The taintedblood.info timeline  -  what really happened...

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1948, 5 July - Creation of NHS - Crown Immunity
The NHS is created and Crown Immunity is applied to all NHS bodies and premises.
Source: Mr A Kerr MSP, Minister for Health Scotland, Submission from Robert Mackie, Agenda Item 2, HC/S2/06/09/06, 18 April 2006
http://www.taintedblood.info/files/1442173861Ag2MackieSubmission.pdf
Type: Statement (Submission) Scottish Parliament
Location: UK
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1958 - Dr. J. Garrott Allen (Former Professor of Surgery, Stanford University)
In 1958, Dr J. Garrott Allen conducts a survey in the Chicago area where he discovers what he refers to as the "prison effect". He finds that there is 10 times more hepatitis in patients who had received blood transfusions from "professional" paid-for blood than in patients who received transfusions from volunteer-donated blood. Dr Allen, warns that plasma centres and blood banks would have to quickly change their methods of operation.
Source: Douglas Starr, "Blood - An Epic History of Medicine and Commerce"
Type: Survey
Location: USA
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1959 - Dr. Judith Pool - Discovery of Cold-Precipitated Factor VIII
Dr. Judith Graham Pool discovers that Factor VIII can be precipitated by cold from normal human plasma, produced a simple and low-cost method of preparing the Factor VIII protein which could then be easily administered to hemophiliacs.

Dr. Pool later goes on to develop a method for determining the concentration of Factor VIII in human plasma.

Source: Teaching Inclusive Science and Engineering, Ellen Mappen, Susan M. Maskery
http://womens-studies.rutgers.edu/modules.pdf
Additional Source: Memorial Resolution, Judith Graham Pool (1919 - 1975)
http://histsoc.stanford.edu/pdfmem/PoolJ.pdf
Type: Discovery
Location: USA
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1959 - MRC - Human Growth Hormone - Clinical Trial
The Medical Research Council runs a growth hormone programme as a clinical trial which commences in 1959 and runs until 1 July 1977. Between 1959 and 1985, nearly 2000 children are treated with the growth hormone, which is extracted from the pituitaries of cadavers (dead bodies).
Source: Clare Dyer, Legal Correspondent, British Medical Journal, 1996:313:185 (27 July)
http://bmj.bmjjournals.com/cgi/content/full/313/7051/185?
Type: BMJ Article - Legal CJD
Location: UK
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1961, May - Haemophilia B Patient is Infected with Hepatitis C virus (HCV) in May 1961
As early as May 1961, a patient is infected with Hepatitis C virus (formally Non-A Non-B Hepatitis (NANBH) from non-virally inactivated factor IX concentrate administered in Oxford.
Source: The Natural History of HCV in a Cohort of Haemophilic Patients Infected Between 1961 and 1985 -T T Yee, A Griffioen, C A Sabin, G Dusheiko and C A Lee.
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1728144
Type: Research Article - The Natural History of HCV in a Cohort of Haemophilic Patients Infected Between 1961 and 1985
Location: UK
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1963 - Dr. Thelin - First Highly-Purified Dried Factor VIII Concentrate
Dr. Thelin, a hemophiliac working as a scientist at Baxter, begins to develop the first factor VIII concentrate, which he initially tests by injecting himself.

He discovers that the freezing and thawing of blood plasma enables him to obtain a layer rich in factor VIII, resulting in the first highly purified dried concentrate of factor VIII.

Source: Baxter Celebrates 50 Years As a Pioneer And Leader In The Biotechnology Industry
http://www.baxter.com/about_baxter/news_room/news_releases/2003/11-10-03-la_50_anniversary.html
Type: Development
Location: USA
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1964 - Judith Pool, Scientist, Stanford University
Cryoprecipitate is discovered in 1964 by a team of scientists led by Judith Pool, who was a student of Dr. J. Garrott Allen.
Source: ON THE TRAIL OF TAINTED BLOOD, Donna Shaw, INQUIRER STAFF WRITER, Philadelphia Inquirer
FINAL Section: EDITORIAL REVIEW & OPINION Page: E01, SUNDAY April 16, 1995
http://hcvets.com//data/transmission_methods/published_articles/philadelphia_inquirer.htm
Type: Cryoprecipitate Discovery
Location: USA
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1964, 16 October - Election - Change of Government
The Labour Party gains power with Harold Wilson as Prime Minister.
Source: http://en.wikipedia.org/wiki/Harold_Wilson
DirectGov, 10 Downing Street
http://www.number10.gov.uk/output/Page129.asp
Type: Political climate
Location: UK
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1965 - West Germany Introduces a Surrogate Test for NANBH in 1965
In the Haemophilia Society's 'Submission to the Archer Inquiry' of 2007, we learn of how many countries used surrogate tests to determine the presence of Non-A Non-B hepatitis (now Hepatitis C):

"The UK was one of the last countries in the western world to introduce a test for hepatitis C. Prior to the discovery of a specific test in 1989, many countries used surrogate tests. These tested people for raised ALT (liver enzyme) levels or hepatitis B. Although surrogate tests were crude and showed a high number of false positives, many countries thought it best to err on the side of caution."

"West Germany introduced a surrogate test in 1965."

"Other European countries such as Italy and France followed suit. The USA introduced surrogate tests in September 1986."

Note: Whilst the main thrust of this entry is to draw attention to the fact that West Germany introduced a surrogate test in 1965, we dispute the reference in the submission that a specific test for HCV was discovered in 1989. We firmly believe that the Chiron Corporation discovered, cloned and sequenced the Hepatitis C virus - the causative agent of Non-A Non-B Hepatitis (NANBH) two years earlier, in 1987. (see related entries link below.)

Source:
Secondary Source: Haemophilia Society Submission to the Archer Inquiry (2007):
http://www.haemophilia.org.uk/UserFiles/Campaign%20briefings/Haemophilia%20Society%20Submission%20to%20the%20Archer%20Inquiry.pdf
Type: Haemophilia Society - Submission to the Archer Inquiry (2007) - Page 23, paragraph 4.
Location: Germany
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1966 - First Blood Clotting Factors are Produced
The first blood clotting products for haemophiliacs are produced.
Source: Sunday Observer, April 16th 2006
http://observer.guardian.co.uk/focus/story/0,,1754868,00.html
Type: Press timeline
Location: UK
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1966 - Baxter Hyland Division - First Commercially Produced Factor VIII Concentrate
The first commercial Factor VIII concentrate is produced by Baxter's Hyland division in 1966 to treat hemophilia.
Source: Baxter Celebrates 50 Years As a Pioneer And Leader In The Biotechnology Industry
http://www.baxter.com/about_baxter/news_room/news_releases/2003/11-10-03-la_50_anniversary.html
Type: Development
Location: USA
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1966, 31 March - Government
There is now a Labour Government and Harold Wilson is in power. Kenneth Robinson is currently Minister of Health. He remains so until October 1968.
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1968 - Krever Report - Hepatitis B Surface Antigen Test Developed
In 1968, a direct test for the presence of Hepatitis B (HBsAg), (Hepatitis B Surface Antigen) is developed and used to identify persons with the disease.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 753
Type: Testing development
Location: USA
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1968, 1 November - DHSS
Richard Crossman becomes Secretary of State for Health and Social Services.
Source: Wikipedia Encyclopedia
http://en.wikipedia.org/wiki/Secretary_of_State_for_Health#Secretary_of_State_for_Social_Services
Type: Political climate
Location: UK
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1969 - Hyland / Courtland Laboratories, L.A. - Dr. J. Garrott Allen
In a study published in 1969, Dr. J. Garrott Allen states that the laboratories of Hyland and Courtland in Los Angeles manufacture from large pools of blood taken from paid "skid row" donors - and because of the increased chance of viral agents being within the pooled blood, that it has to be heated for longer.

Allen also claims that he has been told that neither the National Research Council nor the Government Regulators have inspected the labs, and that there is evidence there that they are not performing within industry standards.

Source: ON THE TRAIL OF TAINTED BLOOD, Donna Shaw, INQUIRER STAFF WRITER, Philadelphia Inquirer
FINAL Section: EDITORIAL REVIEW & OPINION Page: E01, SUNDAY April 16, 1995
http://hcvets.com//data/transmission_methods/published_articles/philadelphia_inquirer.htm
Type: Study
Location: USA
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1970 (early) - Lister Institute of Preventative Medicine
In the early 1970s it becomes clear that the world-renowned Lister Institute is not holding its own financially.
Source: http://www.lister-institute.org.uk/scientificmore.htm
Type: Historical statement
Location: UK
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1970 - National Institutes of Health - Hepatitis
A study published in 1970 states that it only takes 1 unit of blood contaminated with hepatitis to infect the donor pool - even when diluted to 10 millionths, the hepatitis-tainted blood would still be infectious.
Source: Journal of the American Medical Association
http://hcvets.com//data/transmission_methods/published_articles/philadelphia_inquirer.htm
Type: Study - NIH
Location: USA
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1970 - US Pharmaceutical Companies - Distribute Factor VIII / IX
Four US-based pharmaceutical companies to distribute Factor VIII and Factor IX around the world.
Source: Sunday Observer, April 16th 2006
http://observer.guardian.co.uk/focus/story/0,,1754868,00.html
Type: Press timeline
Location: USA
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1970s (early) - Factor Concentrates Become More Widespread
The use of factor concentrates becomes more widespread.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Development. Taken from DOH Self-sufficiency report
Location: UK
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1970s - BMJ Article - Juhani Leikola
Britain is importing huge quantities of Factor VIII from the USA.
Source: BMJ Editorial, BMJ No 7130 Volume 316, Saturday 14 February 1998. Achieving self sufficiency in blood across Europe: European countries should encourage unpaid donors and dismantle barriers - Editorial
http://bmj.bmjjournals.com/archive/7130/7130e3.htm
Type: Editorial article:
Location: USA
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1970s - Donor Exclusion / Recruiting Paid Donors
In the early 1970's, a test is not yet available for the Non-A Non-B Hepatitis virus, so the only means to prevent the virus from contaminating the US plasma supply is to exclude donors with lifestyles that were inconsistent with good health - precisely the populations from which US Pharmaceuticals companies allegedly recruit paid donors.
Source: First Amended Class Action Complaint (2004) (Case No. C032572 PJH). Page 14
Type: Legal document (complaint)
Location: USA
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1970 (early) - Lord Hunt of Kings Heath
UK Clinicians are aware that there is a risk of Hepatitis being spread.
Source: http://www.publications.parliament.uk/pa/ld200102/ldhansrd/vo011015/text/11015-04.htm
Type: House of Lords Hansard, 15 October 2001: Column 340.
Location: UK
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1970, 18 June - Election: Change of Government
The Conservatives are now in power with Edward Heath as Prime minister. Keith Joseph becomes Secretary of State for Health and Social Services.
Source: Wikipedia Encyclopedia
http://en.wikipedia.org/wiki/Secretary_of_State_for_Health#Secretary_of_State_for_Social_Services
Type: Political climate
Location: UK
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1970, 21 December - DoH Advisory Group - Government Knowledge of the Viral Risk of Blood
A letter from G. M. Bebb to Mr. K. A. Sidford shows that the government had knowledge of the viral risk of blood and blood products as well as the virulence of the HAA agent:

"An Advisory Group has recently been set up by the Department of Health under Dr Maycock's chairmanship to make recommendations on the testing of blood donations for the presence of Hepatitis Associated Antigen (HAA) and it's antibody."

The agent is associated with widely reported deaths in renal failure units.

Source: Letter dated 21 December, 1970 from G. M. Bebb writing to K. A. Sidford
Type: Letter
Location: UK
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1971, November - Hepatitis B Screening Becomes Available
Screening for Hepatitis B becomes available.

Note: The screening of donated plasma for hepatitis B, (HBV) is introduced by BPL in November 1971.

Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006).
Notes from Regional Transfusion Directors meeting. 10th January 1973.
Type: Screening development - HBV. Taken from DOH Self-sufficiency Report
Location: UK
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1972 - First Imports of US Commercial Factor VIII
In 1972, commercial factor VIII is imported from the USA into the United Kingdom for the first time.

The paper, entitled "Haemophilia Treatment in the United Kingdom from 1969 to 1974" by Rosemary Biggs, goes on to state that:

"It has been shown that such commercial blood has been 10 times more likely to transmit hepatitis than blood collected from unpaid donors by National Transfusions services." (Maycock 1972).

Source: Rosemary Biggs - Haemophilia Treatment in the United Kingdom from 1969 to 1974
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=871406&dopt=Citation
Type: Recovered Document - Paper for the British Journal of Haematology 1977, 35, 487.
Location: UK
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1973 (early) - Production of Factor VIII in the UK is Insufficient
It becomes apparent that the production of factor VIII in the UK is insufficient to meet the stated needs of clinicians.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Development. Taken from DOH Self-sufficiency Report.
Location: UK
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1973 - First Imports - UK Starts to Import Factor VIII Products
The UK starts to import Factor VIII products as early as 1973
Source: Berridge (1977), Garfield (1994)
Type: First Imports
Location: UK
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1973 - Bayer, Baxter, Armour, Alpha - Intentional Sourcing of Paid Donors
Defendants, Bayer, Baxter, Armour & Alpha Therapeutic, (allegedly) purposefully seek out paid donors despite knowing that the risk of diseases transmissible by blood is far greater among paid donors than among volunteers.
Source: First Amended Class Action Complaint (2004) (Case No. C032572 PJH). Page 14
Type: Legal document (complaint)
Location: USA
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1973, 6 March - G E Godber, Chief Medical Officer - Foreign Imports of Factor VIII
In a DHSS letter from the Chief Medical Officer to all Senior Administrative Medical Officials, the impending availability of foreign human factor VIII concentrate is discussed:

"Product licences have very recently been granted to two firms which enable them to market foreign human AHG concentrate to hospitals and haemophilia centres in the UK. It has come to the notice of the Department that one of the firms is already engaged in active promotion of the very expensive product." (paragraph 3)

Source: DHSS Letter from Chief Medical Officer (CMO), 6 March 1973:
http://www.taintedblood.info/tlfiles/Chief Medical Officer Letter 6 March 1973.pdf
Type: Recovered Document - Letter from G. E. Godber, Chief Medical Officer (CMO), 6 March 1973
Location: UK
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1973, 6 March - DHSS - CMO - Cost Concerns over Foreign Commercially-Produced Factor VIII
In a DHSS letter of 6 March 1973 from the Chief Medical Officer to all Senior Administrative Medical Officers, it is clear that the availability of American and Austrian commercially-produced Factor VIII concentrate is causing cost concerns for the Department:

"Product licences have very recently been granted to two firms which enable them to market foreign human AHG concentrate to hospitals and haemophilia centres in the UK." (page, paragraph 2)

"It has come to the notice of the Department that one of the firms is already engaged in active promotion of this expensive product. The firm has indicated that they can supply large quantities of human AHG concentrate and this could result in very significant expenditure if amounts were bought in excess of immediate needs." (page 2, paragraph 2)

"The Department hope to let you have a further statement soon. Meanwhile, in view of the impending availability of foreign human AHG concentrate and its very high cost, you may like to let all concerned with the treatment of haemophilia in your region know what is happening." (page 2, paragraph 6)

Note: There is no mention of safety concerns, only the usual emphasis on cost.

Source: http://www.taintedblood.info/tlfiles/DHSS CMO Foreign AHG 6 March 1973.pdf
Type: Recovered Document - DHSS CMO letter to All Senior Administrative Medical Officers. Dated 6th March 1973.
Location: UK
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1973, 20 March - DHSS Haemophilia Expert Committee
DHSS Haemophilia Expert Committee recommends 400,000 blood donations be used for Factor VIII, 275,000 donations as concentrate for the production of 12m iu Factor VIII.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Recommendations
Location: UK
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1973, 20 March - DHSS Haemophilia Expert Committee - NHS should be Self-sufficient
DHSS Expert Group on the Treatment of Haemophilia recommends that the NHS should be self-sufficient in blood products as soon as possible.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Recommendations. Take from DOH Sell-sufficiency Report
Location: UK
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1973, 20 March - DHSS Expert Group - Aim for UK Self-sufficiency in Factor VIII
In the recommendations of the DHSS Haemophilia Expert Committee on the Treatment of Haemophilia, under point 3, the following recommendation is made:

"At the same time the U.K. should aim to become self-sufficient as soon as possible by increasing home production of freeze-dried AHG concentrate." (page 4, point 3)

Source: http://www.taintedblood.info/tlfiles/Expert Group on Treatment of Haemophilia 20 March 1973.pdf
Type: Recovered Document - DHSS Haemophilia Expert Group Committee Recommendations. 20 March 1973
Location: UK
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1973, July - Federal Government Conversion to All-Volunteer Blood Supply
US National Blood Policy is adopted by the Federal Government in July 1973. It advocates conversion to an all-volunteer blood supply. The pharmaceuticals, however, not only continued to use paid donors, but also focus their recruiting efforts on the highest risk populations (allegedly).
Source: First Amended Class Action Complaint (2004) (Case No. C032572 PJH). Page 14
Type: Legal document (complaint)
Location: USA
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1974 - Dr. David Owen, Secretary of State for Health - Announcement of Several Million Allocated
Dr David Owen decides that if enough money is invested, the UK can become self-sufficient and blood would then come only from British sources and would be much more likely to not be contaminated.

David Owen announces in the House of Commons that several million pounds has been allocated - but the initiative does not follow through as there is considerable resistance in the Department of Health against putting in the money.

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1974 - World Health Organisation
The World Health Organisation warns Britain in 1974 not to import blood from areas with a high prevalence of Hepatitis - areas such as the United States.
Source: Sunday Times, Scotland
Submission from Robert Mackie, Agenda Item 2, HC/S2/06/09/06, Page 32, 18 April 2006
http://www.scottish.parliament.uk/business/committees/health/papers-06/Ag2MackieSubmission.pdf
Type: WHO Warning, Sunday Times Scotland, August 20, 2000
Location: Scotland / UK
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1974 - Cutter / Dr. J. Garrott Allen (Former Professor of Surgery, Stanford University)
In a study from Dr. J. Garrott Allen of Stanford University Medical Centre, it states that "Cutter sources blood solely from Skid Row derelicts."
Source: ON THE TRAIL OF TAINTED BLOOD, Donna Shaw, INQUIRER STAFF WRITER, Philadelphia Inquirer
FINAL Section: EDITORIAL REVIEW & OPINION Page: E01, SUNDAY April 16, 1995
http://hcvets.com//data/transmission_methods/published_articles/philadelphia_inquirer.htm
Type: Study
Location: USA
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1974 - Rosemary Biggs - Growth in Use of Commercial Factor VIII
Commercial Factor VIII (introduced in 1972) has now grown to account for 13 per cent (13%) of the available clotting factors for persons with Haemophilia A.

Commercial Factor IX is currently available for purchase in the United Kingdom, but there is enough NHS Factor IX, and only small amounts of commercial Factor IX are required.

Source: Rosemary Biggs - Haemophilia Treatment in the United Kingdom from 1969 to 1974
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=871406&dopt=Citation
Type: Recovered Document - Paper for the British Journal of Haematology 1977, 35, 487.
Location: UK
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1974 - ALT Test - Risk from US Prisoners
An alanine aminotransferase (ALT) test is available to test for elevated levels of liver enzymes called SGOT that indicate the presence of hepatitis.

US prisoners are associated with SGOT levels of over 60 IUs per ml, a level that increases the risk of non-A non-B hepatitis (later known as hepatitis C transmission) by a factor of 6.

Despite knowledge of this risk, the US Pharmaceuticals (allegedly) actively recruit PRISONERS for plasma to be used to manufacture Factor VIII and IX, whilst concealing or failing to disclose the risk to hemophiliacs (plaintiffs), their physicians, or the FDA.

Source: First Amended Class Action Complaint (2004) (Case No. C032572 PJH). Pages 16-17
Type: Legal document (Complaint)
Location: USA
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1974 (onwards) - HCDO (Haemophilia Centre Directors' Organisation)
Haemophilia Centre Doctors are reluctant to stop commercial import of products.

Centre Directors (consultants) sign up to receive products for trials.

Source: Meeting Minutes 1974
Type: Trials decision
Location: UK
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1974, 31 January - HCDO Biggs MRC
Haemophilia Centre Directors meeting (with DHSS representative) endorses the Biggs MRC Working Party report recommending UK self-sufficiency on the grounds of cost. A need is recognised for a minimum of 38m to 53m iu products (550,000 to 750,000 donations) per annum, including 500,000 donations solely for concentrate.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Meeting report
Location: UK
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1974, 4 March - Election - Change of Government
Harold Wilson becomes Prime Minister for the Labour Party.
Source: History of the Labour Party
http://www.labour.org.uk/index.php?id=labourhistory
http://en.wikipedia.org/wiki/Harold_Wilson
Type: Political climate
Location: UK
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1974, 5 March - Government - Change of Minister
Barbara Castle is appointed Secretary of State for Health and Social Services.
Source: Wikipedia Encyclopedia
http://en.wikipedia.org/wiki/Secretary_of_State_for_Health#Secretary_of_State_for_Social_Services
Type: Political climate
Location: UK
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1974, 26 July - Government - Change of Minister
David Owen is appointed Minister for Health. He is Minister for Health for some 26 months - until September 1976.
Source: The David Owen Archive - Biographical and Historical Notes, Chronology
http://sca.lib.liv.ac.uk/collections/Owen/biog.htm#Chronology
Type: Political climate
Location: UK
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1974, 3 August - Non-A Non-B Hepatitis - First Predicted by Prince, et al
NANBH strain of hepatitis is first predicted by Prince et al.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Development
Location: UK
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1974, 10 October - Change of Minister
David Owen is still Minister for Health and remains so until September 1976 when he becomes deputy to the Secretary of State for Foreign and Commonwealth Affairs.
Source: The David Owen Archive - Biographical and Historical Notes, Chronology
http://sca.lib.liv.ac.uk/collections/Owen/biog.htm#Chronology
Type: Political climate
Location: UK
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1974, December - Minister of State Earmarks Central Funds of 0.5m
The Minister of State earmarks central funds of 0.5m (half of which is to be recurring). This is to be used to increase the output of plasma from Regional Transfusion Centres (RTCs) to 275,000 blood donations annually for the preparation of factor VIII and 100,000 donations for cryoprecipitate.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006).
Notes from Regional Transfusion Directors meeting. 10th January 1973.
Type: Allocation. DOH Self-sufficiency Report
Location: UK
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1974, 24 December - DHSS
DHSS letter to Regional Transfusion Directors explains that 0.5m has been allocated to make the UK self-sufficient in blood products aiming at using 275,000 donations for concentrate.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Letter
Location: UK
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circa 1975 - Dr J. Garrott Allen of Stanford University, California
Dr J. Garrott Allen, of Stanford University California, writes to the head of the Transfusion Service in the United Kingdom to warn him of the dangers of using United States pooled plasma from high-risk paid donors.
Source: 1975, World in Action Documentary: Blood Money, Granada TV (1975).
Type: Letter
Location: USA
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1975, (beginning) - Expert Group on Haemophilia - Estimates 275,000 Donations Required...
Expert Group on the Treatment of Haemophilia estimates that 275,000 donations of blood will be required to achieve self-sufficiency in factor VIII.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Estimates
Location: UK
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1975 - Yvonne Cossart - Parvovirus B19 - Discovery
While working in a laboratory in London in 1975, Australian virologist Yvonne Cossart discovers, quite by chance, the human Parvovirus B19. The virus can manifest in the following ways:

Fifth Disease (Erythema Infectiosum)
Fifth disease is a mild rash illness with a red, patchy, "slapped cheek" rash on the face. The rash may appear on other parts of the body, such as arms, torso, buttocks, and thighs. Other symptoms such as fever, headache, body ache, sore throat, congestion, runny nose, cough, nausea, or diarrhoea may come before the rash.

Arthritis
Parvovirus B19 can lead to a seronegative arthritis and joint pains in adults and possibly in children.

Foetal Anaemia in Pregnancy
"Parvovirus infection in pregnant women is associated with hydrops fetalis due to severe foetal anaemia, sometimes leading to miscarriage or stillbirth. The risk of foetal loss is about 10% if infection occurs before week 20 of pregnancy and especially between weeks 14-20, but is minimal after then. This risk may be reduced with correct diagnosis of the anaemia (by ultrasound scans) and treatment (by blood transfusions). Once the baby is born, there is evidence to suggest no developmental abnormalities due to B19 infection during pregnancy."

Chronic Anaemia in the Immunocompromised
In people with a compromised immune system, the B19 parvovirus can manifest clinically as chronic anaemia or pure red cell aplasia.

Source: http://en.wikipedia.org/wiki/Parvovirus_B19
Heegaard ED, Brown KE (2002).
http://www.cha.state.md.us/edcp/factsheets/fifth.html
Type: Research Development
Location: Australia
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1975 - Dr Craske - Sudden Rise in the Incidence of Hepatitis
When commercial factor concentrates are introduced more widely between 1974-1975, there is a sudden exceptional spike of 5.2% in the yearly incidence of hepatitis. The yearly incidence otherwise remains roughly the same for 11 years between 1969 and 1980.
Source: Craske J. Public Health Laboratory. The epidemiology of Factor VIII and IX associated hepatitis in the UK. October 1980.
Type: Proceedings of an International Symposium, Royal College of Physicians, Glasgow.
Location: UK
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1975 - Lister Institute of Preventative Medicine
The Lister Institute of Preventative Medicine Chelsea laboratories are forced to close due to repeated annual deficits and failure to secure adequate government support.

Astonishingly, the government stopped funding the only research facility that could have developed heat-treatment and a screening test for Non-A Non-B hepatitis by as early as 1978.

Source: http://www.lister-institute.org.uk/scientificmore.htm
Type: Scientific Heritage Historical statement
Location: UK
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1975, 6 January - Dr. J. Garrott Allen - Stanford University - Warning Letter to Dr Maycock
Dr J Garrott Allen, (former Professor Of Surgery, Stanford University, USA), writes a letter to Dr William Maycock, Head of Blood Transfusion Service, warning of the risks of commercial blood, particularly with regard to non-A non-B hepatitis and that as far back as 1975, that paying blood donors tempts them to lie about their circumstances and that this can compromise safety.

"As you know, Cutter's product Konye, for Factor deficiency, has proved extraordinarily hazardous, a 50-90 percent rate of icteric hepatitis developing from it. About half of these cases prove fatal."

"Cutter's source of blood is 100 percent from Skid-Row derelicts (Transfusion: May/June, 1974)."

Note: It is sad to read of the detrimental consequences of the UK purchasing commercial Factor VIII and IX upon the USA's attempts to form their own volunteer donor programs.

Source: http://www.taintedblood.info/tlfiles/Warning Letter J Garrott Allen to Maycock 6 January 1975.pdf
Type: Letter. Dr J Garrott Allen writing to Dr William Maycock of BPL. Dated 6th January 1975.
Location: USA
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circa 1975 - David Owen - Money Apportioned-Off for Protection of Haemophiliacs is Diverted
Money that is apportioned off for the protection of haemophiliacs is "diverted to other purposes". (Former Health Minister, Lord Owen speaking with reference to 1975, on the BBC's "Face the Facts" programme in August 2001).
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1975, 22 January - David Owen Announces Programme to make UK Self-sufficient in Blood Products
On 22 January 1975, Dr David Owen as a Minister in the Department of Health and Social Security, announces to the House a programme to make the UK self-sufficient in blood products, particularly Factor VIII.
Source: Hansards, House of Commons, 23 November 1989, end of Column 271
http://www.publications.parliament.uk/pa/cm198990/cmhansrd/1989-11-23/Debate-5.html#Debate-5_spnew2
Type: House of Commons Hansard
Location: UK
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1975, March - DOH - Regions Given Provisional Targets of Increased Production of Plasma
The DOH gives Regions provisional targets of increased production of plasma and invites estimates of the additional expenditure that will be incurred.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Requirements. Taken from DoH Self-sufficiency Report
Location: UK
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1975, 6 March - Dr David Owen - Intention of the Allocated Half-Million for BPL
In a government Written Answer from 6 March, 1975, it clearly shows David Owen's intention for the pledged 500,000 to increase production, not to increase donations; which is where it eventually ended up:

Dr David Owen: "As I told my hon Friend the Member for Sowerby on 17 February, I have authorised the allocation of special finance of up to 0.5m (about half of which would be recurring) to increase the existing production of AHG concentrate within the National Health Service with the aim of the NHS becoming self-sufficient as soon as possible" (final paragraph)

Note: This demonstrates government maladministration as the 500,000 was in fact used by the RTC, leaving BPL Elstree short-changed. The DHSS should have insisted on the extra money being allocated to its intended purpose - which was to fight this threat to public safety.

Source: http://www.taintedblood.info/tlfiles/Hansard Written Answer 6 March 1975.pdf
Type: Recovered Document - Hansard - Written Answer. 6 March 1975.
Location: UK
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1975, 22 April - Dr David Owen - Pledge - Self-sufficiency
David Owen repeats that pledge of making the UK self-sufficient; when he said it, he had hoped that it would be done in 2 to 3 years.
Source: Hansards, House of Commons, 23 November 1989, Column 272
http://www.publications.parliament.uk/pa/cm198990/cmhansrd/1989-11-23/Debate-5.html#Debate-5_spnew2
Type: House of Commons Hansard
Location: UK
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1975, May - WHO Resolution - Each Country Should Supply Sufficient Quantities...
World Health Organisation (WHO) issues a resolution stating that each country should be able to supply sufficient quantities of its own blood and blood products to meet clinical needs.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Resolution
Location: UK
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1975, 13 May - J Walker SHHD and Health Board Secretaries
According to correspondence between J Walker SHHD and Health Board Secretaries:
"In England and Wales the view is taken that in law the activities of health authorities attract Crown Exemption so that the provisions of the Medicines Act are not binding on them. Arrangements are being made whereby health authorities will be brought within the licensing provisions of the Act in a manner analogous to that which applies to commercial pharmaceutical manufacture."
Source: Scottish Parliament, Submission from Robert Mackie, Agenda Item 2, HC/S2/06/09/06, 18 April 2006
http://www.taintedblood.info/files/1442173861Ag2MackieSubmission.pdf
Type: Correspondence on Crown Immunity
Location: UK
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1975, August - Mannucci, et al - Raised ALT Levels...
Mannucci et al. report that 45% of patients with Non-A Non-B Hepatitis (NANBH) had raised ALT Levels.
Source: Mannucci PM, Capitanio A, Del Ninno E, Colombo M, Pareti F, Ruggeri ZM. Asymptomatic liver disease in haemophiliacs. J Clin Pathol. 1975;28(8):620-4.
Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Research
Location: UK
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1975, August - Travenol Hemofil - Outbreak of Hepatitis B
In August 1975, Travenol withdraws Hemofil after the product is associated with an outbreak of Hepatitis B. It is recognised that commercial factor concentrates are associated with these outbreaks.
Source: Lindsay Tribunal Report. Pages 65, 175-176, 274.
Type: Product Withdrawal - Hemofil
Location: UK
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1975, 2 August - Dr Craske, et al
Dr Craske, et al, report in Lancet an outbreak of hepatitis in England that shows that commercial concentrate is more risky than NHS concentrate.
Source: HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Lancet report
Location: UK
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1975, 2 August - Dr Craske, et al. - Hepatitis Outbreak - Commercial Factor VIII
At a haemophilia centre in Bournemouth, there is an outbreak of hepatitis which is associated with 3 out of 4 batches of a commercial brand of freeze-dried factor VIII concentrate between the months of April and June 1974.
  • 18 out of 20 patients receive commercial factor VIII
  • 9 patients become ill out of a total of 18
  • there are 4 cases of hepatitis B within 6 months of product use
  • there are 7 cases of non-B hepatitis
  • 2 of the patients contract both types of hepatitis
Source: Craske J, Dilling N, Stern D. An outbreak of hepatitis associated with intravenous injection of factor-VIII concentrate.
The Lancet: 1975 August 2,2 (7927): 221-3.
http://www.taintedblood.info/tlfiles/Medical Research Council Minutes 1980.pdf
Type: Lancet Article - Hepatitis Outbreak
Location: UK
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1975, Autumn - Hepatitis B Outbreak in Haemophiliac Boys at the Lord Mayor Treloar School, Alton
In the Autumn of 1975, there is an outbreak of hepatitis B infections among haemophiliac pupils at the Lord Mayor Treloar College in Alton, Hampshire.

We know from the witness testimony of a former pupil who was in his second year at the school in 1975, that the epidemic down in Alton concerned hepatitis B infections and the outbreak involved around ten boys from the school. One of them was in his dormitory and, by coincidence, the morning the outbreak was registered was the same morning of the school medical, and he woke up looking yellow-faced. The boys involved were informed that it would take around 6 months for them to fully recover.

Note: It is disconcerting to learn that all of the infected boys were forced to endure the stigma of having small red spots (as markers) put on their meal plates and were required to specifically hand their marked plates in to canteen staff, in person, in order for them to be sterilised.

Source: Former Member of the Lord Mayor Treloar College.
Type: Testimony of Former Member of the Lord Mayor Treloar College in their second year with reference to Autumn 1975.
Location: UK
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1975, December - Dr Craske, et al. - Commercial Factor VIII Associated Hepatitis
A retrospective survey of cases of hepatitis associated with a commercial brand of factor VIII is carried out in 24 Haemophilia Centres in the UK from January 1974 until December 1975. Four of the suspect batches of concentrate are found to be positive for HBsAg.
  • 371 patients are transfused with the commercial product
  • There are 78 cases of hepatitis affecting 66 patients (17.7%)
  • 1 patient dies after contracting Hepatitis B
  • 12 patients contract 2 types of hepatitis: Non-B hepatitis, then HBV later on
Source: Craske J, Kirk P, Cohen B, Vandervelde EM. J Hyg (Lond). 1978 June: 80(3): 327-36.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=649945&dopt=Abstract
Type: Article - Retrospective Study.
Location: UK
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1975, 8 December - BPL
BPL decides to increase donations. The pool size increases from 830 donations to 2,000 donations.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Decision
Location: UK
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1976 - FDA Conference - Factor Concentrates - Liver Dysfunction

In 1976, only a few years after the factor concentrate products of Bayer, Baxter, Armour & Alpha Therapeutic go on the market, the United States Food and Drug Administration (FDA) Bureau of Biologics holds a Conference entitled "Unsolved Therapeutic Problems in Hemophilia."

The research articles compiled from the Conference discuss the high incidence in patients using these products of disorders such as liver dysfunction, enlarged spleen, Hepatitis B, and Non-A Non-B Hepatitis. The articles conclude that these disorders were tied to the patients' use of factor concentrates, and emphasized the risks entailed in producing such concentrates using plasma from paid donors.

Source: MDL 986 Class Action Plaintiffs Complaint (2004) LCHB, LLP Page 12
Type: Legal document (complaint)
Location: USA
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1976 - BTSB - Anti-D Agent Manufactured Using Blood Products from a Jaundiced Donor
The Blood Transfusion Service Board manufactures "Anti-D" agent (from human blood) using blood products that originated from a donor who had jaundice.
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1976 - Dr McDonald - Commercial Factor VIII
Dr. McDonald, in a meeting of the HCDO, states that "commercial factor VIII was at present used in the West of Scotland. In 1976, 14% of all factor VIII was commercial." The supply of NHS factor VIII was increasing and in 1976, 46% of all factor VIII used was freeze dried NHS intermediate potency concentrate.
Source: Agenda item 3, point 3, page 12, headed "Activities of Reference Centre Directors and the supply of Factor VIII"
http://www.taintedblood.info/tlfiles/UKHCDO_1977.pdf
Type: Minutes of the meeting of Haemophilia Centre Directors of the United Kingdom. 13th January 1977, Middlesex Victoria Infirmary London.
Location: Scotland
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1976 - Dr Helen Dodsworth Commenting on BPL Elstree Situation
In a transcript of a Witness Seminar held at the Wellcome Institute for the History of Medicine which took place in London on 10 February 1998, Dr Helen Dodsworth refers (retrospectively) to her time in 1976 when she sat on a committee convened to advise the Department of Health on how much factor VIII concentrate was needed to treat patients in the UK:

Dr Dodsworth speaking in 1998 with reference to 1976: "Our spokesman, Dr Tovey, the Director of the Bristol Transfusion Centre, had been through a similar exercise for the World Health Organization in Geneva. He persuaded us that if we wanted to treat our patients adequately, it would be necessary to fractionate at least 80 per cent of the blood that was donated. At this point the Government decided that money was available for neither extending the fractionation unit at Elstree nor for equipping the transfusion centres to separate yet more plasma from donor units."

Dr Dodsworth speaking in 1998: "So this is really why we found ourselves buying large quantities of factor VIII concentrate from America, and why we infected so many of our patients with HIV."

Source: Transcript of a Witness Seminar held at the Wellcome Institute for the History of Medicine, London, 10 February, 1998, (see pages 29-30):
http://www.taintedblood.info/files/1440596948Haemophilia_Recent_History_of_Clinical_Management_10_Feb_1998.pdf
Type: Transcript, 10th February 1998. Edited by D A Christie and E M Tansey,
Location: UK
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1976, 20 February - DHSS - AHG Concentrate (Factor VIII) - Hepatitis Risk
In a DHSS memorandum of 20th February, 1976, the following is discussed with reference to Factor VIII concentrate:

"The line of reply from Oxford does not surprise me. They are correct in stating that they are a major producer of AHG without which the programme will founder, something we cannot possibly contemplate as the Minister of State has only recently reaffirmed his aim of NHS self-sufficiency in this substance. Quite apart from this, the alternative of buying the commercial product (with its higher hepatitis risk) is more costly than producing our own." (paragraph 1)

Source: http://www.taintedblood.info/tlfiles/DHSS Memorandum 20 February 1976.pdf
Type: Recovered Document - DHSS Memorandum, 20 February 1976
Location: UK
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1976, 25 March - MHRA / Armour (Medicines and Healthcare Regulatory Agency)
The MHRA grants a product licence for Factor VIII (PL 00231/0038 FACTORATE INJECTION - HEAT) to Armour Pharmaceutical Company Limited.

Note: The granting of this licence is one of the earliest Factor VIII product licences that we know of.

The licence documentation for this product clearly states the word "HEAT" in the description of the licence name. The word is in brackets but it appears that some text is missing, as the brackets are not closed. It is interesting to note the use of the word HEAT as early as March 1976.

Source: Medicines and Healthcare Regulatory Agency (MHRA) Marketing Authorisation, Product Licences for Clotting Factors Granted 1974-1978.
http://www.taintedblood.info/tlfiles/MHRA Licences 1974 to 1978.pdf
Type: MHRA Licence
Location: USA
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1976, April - DOH Re-affirms Aim of the UK to Become Self-sufficient in Blood Products
DOH issues a press release re-affirming the aim of the UK to become self-sufficient in the supply of blood products by mid-1977.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Press release. Taken from DoH Self-sufficiency Report
Location: UK
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1976, 5 April - General Election
James Callaghan becomes Prime Minister for Labour on 5th April 1976.
Source: DirectGov, 10 Downing Street
http://www.number10.gov.uk/output/Page127.asp
http://en.wikipedia.org/wiki/James_Callaghan
Type: Political climate
Location: UK
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1976, 8 April - Government - Change of Minister
David Ennals becomes Secretary of State for Health and Social Services on 8 April, 1976 and remains so until 4th May,1979.
Source: Wikipedia Encyclopedia
http://en.wikipedia.org/wiki/Secretary_of_State_for_Health#Secretary_of_State_for_Health
Type: Political climate
Location: UK
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1976, 29 April - Dr David Owen - World Federation of Haemophilia - Speech
In a speech to the World Federation Haemophilia Congress, David Owen repeats the self-sufficiency pledge again, where he states that we hoped to be self-sufficient in blood products by mid-1977, he was not speaking in the House, so that statement did not bind successive Governments.

Note: The Government is, however, responsible for the two earlier pledges that were given in the House. The targets are not achieved and the UK is still not self-sufficient in blood products.

Source: Hansards, House of Commons, 23 November 1989, Column 272
http://www.publications.parliament.uk/pa/cm198990/cmhansrd/1989-11-23/Debate-5.html#Debate-5_spnew3
Type: House of Commons Hansard
Location: UK
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1976, 29 April - Dr David Owen - Self-Sufficiency - Intended Use of Half Million
In a DHSS memo entitled "UK Aims to be Self-Sufficient in Supply of Blood Products", the following is stated by Dr. David Owen:

"Following a special allocation of 500,000 last year substantial progress was now being made in building up production capacity in the NHS, and self-sufficiency in home-produced Factor VIII was expected to be reached in mid-1977." (paragraph 3)

Note: The half million, (intended for building up capacity within the NHS) was, in fact, NOT used for building-up production capacity for self-sufficiency and instead ended up being paid out to increase the amount of people donating blood in the UK.

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1976, 4 May - Expert Group on Haemophilia
Expert Group on Haemophilia meets. The old target of 31m-34m iu is believed to be out-of-date. They agree to wait until the old target is achieved before reviewing the situation.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Meeting
Location: UK
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1976, 4 May - Expert Group on the Treatment of Haemophilia - Factor VIII Concentrates
In the minutes of a meeting at the DHSS of the Expert Group on the Treatment of Haemophilia and Allied Conditions on 4th May, 1976, it was accepted that:

"There was no shortage of concentrate in the UK. Commercial producers could meet all the requirements likely to be made on them, on demand, but at considerable cost." (page 3, paragraph 1)

"It was suggested that the money at present being spent on commercial concentrate might be better spent if it was used to increase still further the output of NHS concentrate but it was generally agreed that money was not the only limiting factor. The Chairman drew attention to the fact that expenditure on commercial concentrate was continuing to rise even though more NHS concentrate was becoming available." (page 3, paragraph 2, lines 1-6)

The Department agreed to bear in mind the following:

"Of the English and Welsh Blood Transfusion Centres only Manchester RTC distributed commercial concentrate at present." (page 6, paragraph 2)

"The view was expressed that the purchase of commercial concentrate should be a Regional rather than an Area responsibility." (page, 6, paragraph 3)

Source: http://www.taintedblood.info/tlfiles/Expert Group on the Treatment of Haemophilia 4 May 1976.pdf
Type: Recovered Document - Minutes of the Expert Group on the Treatment of Haemophilia 4 May 1976
Location: UK
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1976, June - DHSS
DHSS realises need for comprehensive review of future needs of blood products and fractionation capacity.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Review
Location: UK
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1976, 27 July - BPL Elstree - Trial of FVIII Concentrates in Lord Mayor Treloar College
In a document called "Blood Products and Plasma Fractionation Laboratories", it states on page 4 that there is an active collaboration between Elstree and Oxford in 3 clinical investigations (TRIALS):

"Trial of factor VIII concentrate in prophylaxis BPL Elstree, Lord Mayor Treloar College, Alton." (page 4, paragraph 4)

Note: We have to wonder whether the pupils' or parents' consent was gained prior to a trial being conducted in a school? Using a new medicine for the sake of improved health, or improved yield of Factor VIII is one thing, but using the new concentrates as part of trials connected to a collaborative study is quite another.

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1976, 27 July - BPL Elstree / PF Laboratories - Inspection Failings
In a document entitled "Blood Products and Plasma Fractionation Laboratories" there is clear knowledge of the shortcomings of both BPL and the PF Laboratory in July 1976:

"PF Laboratory has been inspected. BPL will be visited in October." (page 7, paragraph 2, line 1)

"It is not unlikely that the accommodation of both laboratories will be criticised and, in certain respects, found inadequate. Both were designed before the Medicines Act was passed and therefore several years before those responsible for applying this Act had formulated the criteria to be met." (page 7, paragraph 3)

Note: It is quite disgusting that these failings at BPL Elstree coincide with the use of their factor VIII concentrates in trials involving children at the Treloar boarding school.

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1976, 12 August - Factor VIII and Cryoprecipitate Supplies - Targets
In a letter dated 12 August 1976, the target of factor VIII production from all sources was a usage of over 40 million international units per annum. Plans had been agreed to produce 35 million i.u. per annum. It was pointed out that in theory this level of production had already been achieved in England and Wales, assuming a yield of 60 i.u. of factor VIII activity per donation of plasma processed to cryoprecipitate.

"We know that in addition clinicians are buying and using or accumulating commercially produced factor VIII concentrate at the rate of 10 million i.u. per annum." (paragraph 3)

"There is some highly potent cryoprecipitate about. I understand that the Edgware product contains levels of 100 i.u. factor VIII or more consistently." (paragraph 4, lines 1 and 2)

Source: http://www.taintedblood.info/tlfiles/Factor VIII Supplies 12 August 1976.pdf
Type: Recovered Document - Letter ref. Factor VIII Supplies, 12 August 1976
Location: UK
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1976, 27 August - MHRA / Porton Speywood Ltd
The MHRA grants Porton Speywood Ltd a product licence for Factor VIII (PL 03070/0004 HUMANATE AHF CONCENTRATE).
Source: Medicines and Healthcare Regulatory Agency (MHRA) Marketing Authorisation, Product Licences for Clotting Factors Granted 1974-1978.
http://www.taintedblood.info/tlfiles/MHRA Licences 1974 to 1978.pdf
Type: MHRA Licence
Location: UK
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1976, 10 September - Government - Change of Minister
Roland Moyle is appointed Minister for Health on 10 September 1976 and remains so until 4th April, 1979.
Source: Ministers who have left the DHSS
http://www.psr.keele.ac.uk/table/york/DHSSresign.html
The Origins of the Faculty of Public Health Medicine, Michael D Warren
http://www.fph.org.uk/policy_communication/downloads/publications/Origins_of_the_Faculty.pdf
Type: Political climate
Location: UK
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1976, October - Dr Alan Dickinson (MRC) on Risk of CJD in Human Growth Hormone
In October 1976, Dr Alan Dickinson, a veterinary scientist of the Agricultural Research Council, who is working on scrapie, telephones the MRC to alert officials to the risk of transmission of CJD through human growth hormone.
Source: Clare Dyer, Legal Correspondent, British Medical Journal, 1996:313:185 (27 July)
http://bmj.bmjjournals.com/cgi/content/full/313/7051/185?
Type: BMJ Article - Legal - CJD
Location: UK
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1976, 15 October - MHRA / Baxter
The MHRA grants a product licence to Baxter Healthcare Limited for Factor IX (PL 00116/0049 PROPLEX FACTOR IX COMPLEX.
Source: Medicines and Healthcare Regulatory Agency (MHRA) Marketing Authorisation, Product Licences for Clotting Factors Granted 1974-1978.
http://www.taintedblood.info/tlfiles/MHRA Licences.pdf
Type: MHRA Licence
Location: USA
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1976, 2 November - Central Committee - NBTS - Readmission of Jaundice Donors
In the minutes of the Central Committee for the National Blood Transfusion Service, under point 3.5 (item 10), testing for hepatitis B surface antigen and its antibody is discussed:

"With the agreement of the Advisory Group, the Department had decided that the recommendation to readmit to donor panels persons with a history of jaundice would be permissive; Regional Transfusion Directors could exercise their individual clinical judgement in the matter." (page 2, line 2)

Note: It is appalling to see that in 1976, the Department allowed the readmission of people with a history of jaundice to return to donor panels. We strongly disapprove of a decision which helped expose persons with haemophilia to hepatitis B.

Source: http://www.taintedblood.info/tlfiles/Central Committee National Blood Transfusion Service 2 November 1976.pdf
Type: Recovered Document - Minutes of the Central Committee for the National Blood Transfusion Service
Location: UK
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1977 - Web source - Anti-D
6 women develop jaundice (later identified as Hepatitis C) shortly after giving birth, after having been treated with contaminated "Anti-D" which is derived from blood products.
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1977 - Department of Health - Human Growth Hormone Programme
The MRC human growth hormone programme is taken over by the Department of Health in 1977.
Source: Clare Dyer, Legal Correspondent, British Medical Journal, 1996:313:185 (27 July)
http://bmj.bmjjournals.com/cgi/content/full/313/7051/185?
Type: BMJ Article - Legal - CJD
Location: UK
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1977, circa - Labour Announces that Britain would be Self-sufficient by 1979...
In an article in the Observer on 24th August 1986 entitled "AIDS Victims Could Sue for Millions, Says Lawyer" we discover a claim by the then Labour government that Britain would be self-sufficient in blood products by 1979...

"The case against the Government hinges upon the time it took to build a huge blood products laboratory at Elstree, Hertfordshire, which could have provided safe supplies of Factor VIII for British sufferers."

"The Labour Government announced in 1977 that the plant would be finished by 1979, and that Britain would be self-sufficient in blood products, and would no longer have to import any from the United States."

Source: Observer Article: 24th August 1986 (Link to Guardian Repository)
Type: Press Article - Observer. AIDS Victims Could Sue for Millions, Says Lawyer. 24th August 1986.
Location: UK
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1977 - NHLBI Report (US)
A report in 1977 by NHLBI (US) notes that albumin, another plasma product, is "heat treated to remove almost all danger of hepatitis".
Source: NHLBI 1977 Report. Id., at p. 49
Type: Report
Location: USA
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1977 - Dr Peter Levine - Immune Complex Disease
Several articles from a US Conference raise alarm over the unprecedented convergence of immune disorders in the US hemophiliac community, and there's a call for close medical monitoring of the situation:

Dr. Peter Levine: "One wonders whether our patients are suffering a sort of immune complex disease as a result of intensive bombardment with foreign antigens...."

Source: Levine, "Unsolved Problems with Current Therapeutic Regimens for Hemophilia" (1977).
Additional Source: MDL 986 Class Action Plaintiffs Complaint (2004) LCHB, LLP. Page 13
Type: Article
Location: USA
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1977, 13 January - HCDO - Hyland - Paid Consultants - Fractionation Expansion Hold-up
Some consultants are in receipt of payments from companies producing Factor VIII products.

Dr Jones is a paid consultant to Hyland Laboratories in 1977.

Professor Blackburn reports that there is a hold-up in the expansion of fractionation in the UK. Prof. Blackburn is planning to organise a meeting to look into ways of expanding the facilities for fractionating.

Source: Minutes of the meeting of Haemophilia Centre Directors of the United Kingdom. 13th January 1977, Middlesex Victoria Infirmary London, Agenda item 3, point 2, page 11, headed "Activities of Reference Centre Directors and the supply of Factor VIII".
Type: HCDO Minutes
Location: UK
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1977, 13 January - Dr Waiter (HCDO) - Use of Facilities at Liberton
Dr Waiter of DHSS tells Haemophilia Centre Directors' meeting of a commitment to use the facilities at Liberton, Scotland.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Meeting
Location: Scotland
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1977, 13 January - Professor Stewart (HCDO) Problem of Distilled Water
In a meeting of the HCDO in 1977, Prof. Stewart of Middlesex Hospital Medical School, states that there is still a problem in finding distilled water to dissolve the NHS concentrate.

Prof. Stewart: "The commercial concentrates were supplied with water for solution which was an advantage." Dr. Ellis said that Elstree was looking into this problem and might in the future supply the water with the concentrate.

Source: Minutes of the UKHCDO. 13th January 1977, Agenda item 3, point 3, page 14, headed "Activities of Reference Centre Directors and the supply of Factor VIII."
http://www.taintedblood.info/tlfiles/UKHCDO_1977.pdf
Type: Minutes - Minutes of the Haemophilia Centre Directors of the United Kingdom. 13th January 1977
Location: UK
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1977, 13 January - HCDO - Factor VIII Supply / Liberton Scotland
In a meeting of the HCDO in 1977, Prof. Blackburn states that it seems as if the PFC at Liberton Scotland has the capacity to supply factor VIII for the whole U.K.

Dr. Waiter states that plans have been made to divert plasma from South of the Border to Liberton when Mr. Watt is ready to receive it. The Factor VIII made from this plasma would return to Centres south of the Border. Agreement in principle has already been reached between the DHSS in London and the Scottish Home and Health Department.

Dr. Rainsford (of the Lord Mayor Treloar College, Hants), asks "if England and Wales would be charged for the use of the fractionation facilities in Scotland? If so, might it be as well to continue to buy commercial concentrates?"

Source: Agenda item 3, point 3, page 13, headed “Activities of Reference Centre Directors and the supply of Factor VIII”:
http://www.taintedblood.info/tlfiles/UKHCDO_1977.pdf
Type: Minutes of the meeting of Haemophilia Centre Directors of the United Kingdom. 13th January 1977, Middlesex Victoria Infirmary London.
Location: Scotland
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1977, 13 January - HCDO - Agreement to Send Haemophiliac Boys to Treloar School
In the minutes of a meeting of the HCDO on 13th January 1977, Dr Rainsford, of the Lord Mayor Treloar College, drew attention to the fact that the number of haemophilic boys applying for admission to the college had decreased and that there were only 4 applications that year compared with 7 the year before.

He wished to know if Haemophilia Centre Directors were changing their policy with regard to sending boys to the College. The comment was made that the decrease in haemophiliacs applying for admission was in all likelihood a reflection of the improvement in haemophilia treatment throughout the United Kingdom both at Centres and by home therapy.

Note: We would like to pose the question as to whether there some sort of agreement between Haemophilia Centre Directors that they would 'channel' their patients toward the school each year on behalf of Dr Rainsford?

Who, then, decided to send the haemophiliac boys to the school? Was it the Local Authorities, school headmasters, GPs or local haemophilia centre Consultants, or did the school approach families direct?

Background: Unfortunately, we have reason to believe that in some cases children were actually 'forced' to go to the school by their Local Education Authorities on the supposed grounds that it was the only way the LEA felt able to fulfil their legal obligation to provide an adequate education... and parents would have been 'forced' into it as well. Also, we would like to point out that some children with haemophilia came from unstable family backgrounds and were encouraged to be just dumped at the school.

Source: http://www.taintedblood.info/tlfiles/Extract of HCDO Minutes 13 Jan 1977 ref Treloar.pdf
Additional Source: Testimony of Former Member of the Lord Mayor Treloar College.
Type: Extract from the Minutes of a meeting of the HCDO 13th January 1977
Location: UK
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1977, February - Dr Alan Dickinson - Safety of Human Growth Hormone
In a letter in February 1977, Dr Alan Dickinson, veterinary scientist, makes 4 suggestions to improve the safety of the human growth hormone. Two suggestions are never acted upon, a third is only partly implemented, and the fourth - which is to exclude the use of pituitaries from cases with dementia - is not put into force until 1980.
Source: Clare Dyer, Legal Correspondent, British Medical Journal, 1996:313:185 (27 July)
http://bmj.bmjjournals.com/cgi/content/full/313/7051/185?
Type: BMJ Article - Legal - CJD
Location: UK
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1977, 2 February - DHSS - Fate of Floundering Lister Institute
In a DHSS letter of 2nd February 1977, a viability study of the world-renowned Lister Institute is discussed. The letter states that a conclusion has been reached:

"the Department should not on financial grounds make a loan or grant to [Lister?] and that the possible consequences of [Lister?] ceasing to produce sera and vaccines should be accepted". (Paragraph 1, lines 3-5)

"Nevertheless we should be faced with very real difficulties if [Lister?] were to be wound up" (Line 4 of paragraph 3)

"Any disruption in production during this interim period, which could well arise if we were forced to act too quickly, would probably cause clinicians to fall back on commercial suppliers of blood products, thus adding to the total cost of the NHS as well as inducing a setback for Ministers' policy of UK self-sufficiency in blood products production" (Last 6 lines of paragraph 3)

Note: This situation ended up with the Lister Institute's Elstree Lab closing in 1978 due to repeated annual deficits coupled with the need for major expenditure in order to modernise the production facilities. The Lister Institute was well-poised to possibly go on to develop heat-treatment or even a test for NANBH by as early as 1978 - if only the Government had made that loan or grant.

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1977, 3 February - MHRA / Lister Institute of Preventative Medicine - Product Licence
The MHRA grants Lister Institute of Preventative Medicine a product licence for Factor VIII (PL 00134/0007 HUMAN ANTIHAEMOPHILIC FRACTION).
Source: Medicines and Healthcare Regulatory Agency (MHRA) Marketing Authorisation, Product Licences for Clotting Factors Granted 1974-1978.
http://www.taintedblood.info/tlfiles/MHRA Licences.pdf
Type: MHRA Licence
Location: UK
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1977, 3 March - MHRA / Lister Institute of Preventative Medicine - Product Licence
The MHRA grants Lister Institute of Preventative Medicine a product licence for Dried Factor VIII Fraction (PL 00134/0008 OCTOCOG ALFA).
Source: Medicines and Healthcare Regulatory Agency (MHRA) Marketing Authorisation, Product Licences for Clotting Factors Granted 1974-1978.
http://www.taintedblood.info/tlfiles/MHRA Licences.pdf
Type: MHRA Licence
Location: UK
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1977, 23 March - Limited Amounts of Cryo may be Produced Literally Overnight
The following was included in the evidence submitted to the Penrose Inquiry, yet made little or no difference.

In "Blood Transfusion for Clinicians" (1977), Dr John Wallace writes about the advantages of cryoprecipitate over Factor VIII concentrates:

"The one great advantage which cryoprecipitate has over the other concentrates of factor VIII is that it can be prepared quickly. With an average daily intake of 500 donations it is possible to maintain a daily production of 100 single donations of cryoprecipitate, and the processing of donations to the finished product takes only 24 hours. On the contrary, the complete processing of large batches of fresh frozen plasma to provide intermediate concentrate of factor VIII may occupy two to three months from start to finish. The total yield of the respective products may be virtually the same over the long period of months, but limited amounts of cryoprecipitate may be produced literally overnight."

Note: Although this entry relates to 1977, the situation with regard to cryo production is pretty much the same in 1984 (see Related Entries link below).

As soon as even the slightest warnings over AIDS started to emerge, it is clear that between the DH and Transfusion Centres (RTCs), they could have mustered up sufficient cryoprecipitate to treat only the most serious of bleeds, and they could have done this much more quickly than we have ever been led to believe...

The tragedy that unfolded was compounded (even caused) by a terrible decision made by the Committee on Safety of Medicines in July 1983, where those present dismissed the possibility of withdrawing clotting factor concentrates from the market and replacing them with cryoprecipitate. The reason cited was that it was not feasible in the UK on grounds of supply.

Source: Blood Transfusion for Clinicians, John Wallace (1977)
http://www.penroseinquiry.org.uk/finalreport/pdf/LIT0013058.PDF
Type: Penrose Evidence File
Location: UK
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1977, June - Target of Early 1975 Attained But Factor VIII Demand Increases...
The Factor VIII production target that was set in the beginning of 1975 is attained; however demand has increased.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Statement. Taken from DOH Self-sufficiency Report
Location: UK
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1977, 2 June - DHSS - RTDs - Biggs Estimate of Demand for Factor VIII
In a letter of June 1977 from the DHSS, entitled "The Distribution of Factor VIII", it states that:

"Biggs in her recent paper (B.Journ.Haemat. 1977,35,487) estimates the clinical demand for factor VIII at 50 million I.U. per annum in the UK of which at least half, and preferably all should be in the form of the concentrate." (Page 1, point 3.)

Source: Letter from DHSS, Med SM4, Hannibal House, 2 June 1977.
http://www.taintedblood.info/tlfiles/DHSS Letter Factor VIII Distribution 1977.pdf
Type: Recovered Document - Letter
Location: UK
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1977, July - BPL Reaches Target of 2.5 Million i.u. per annum
BPL reaches its target of 1,000 litres a week (2.5m iu per annum).
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Target
Location: UK
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1977, 4 July - WHO Report - Another Type of Hepatitis - Unrelated to Hepatitis A or B Virus
In a World Health Organisation (WHO) Report on Viral Hepatitis in 1977, there is evidence of progress in the diagnosis of hepatitis that has revealed a new type that is unrelated to hepatitis A or B virus.

It is stated in the report, that this new type of hepatitis virus appears to be the most common form occurring after blood transfusion - in some areas. (Page 3, paragraph 4)

Source: http://www.taintedblood.info/tlfiles/WHO Report on Viral Hepatitis 4 July 1977.pdf
Type: Recovered Document - World Health Organisation (WHO) Report on Viral Hepatitis. Dated 4th July 1977.
Location: UK
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1977, 14 July - National Blood Transfusion Service - Future of Cryoprecipitate
In a letter to the DHSS from the NBTS, in 1977, the following is expressed in relation to Cryoprecipitate:

"...In view of these facts which, I am sure are well known to everyone, I am surprised that we are exercising our minds towards the improvement of a product which is destined for obsolescence..."

"...Haemophilia Centre staff appear to favour concentrate, it being easier to use, more versatile and having a longer storage life. I, therefore, feel that the only solution that we have in sight for adequately treating the country's haemophilia population is to push wholeheartedly and enthusiastically towards the phasing out of cryoprecipitate."

"Failure to do this is just delaying the inevitable. Probably, time and money would be better used in convincing the health departments to enlarge production facilities to obviate the use of foreign currency for purchase of commercial factor VIII."

Source: http://www.taintedblood.info/tlfiles/NBTS Letter to DHSS 14 July 1977.pdf
Type: Recovered Document - Letter from the NBTS to the DHSS, dated 14 July, 1977.
Location: UK
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1977, 24 October - Dr McDonald - UKHCD Meeting - Factor VIII supply
In May 1977, Dr McDonald was invited to organise a meeting of representatives of those closely involved in the problems of factor VIII supply; namely DHSS, Scottish Home and Health Department (SHHD), Fractionation Laboratories, Blood Transfusion Centres and Haemophilia Centres. Dr McDonald's preliminary enquiries showed that in some quarters there was little interest in such a meeting. So no meeting had been arranged.
Source: UKHCD Meeting Minutes, 24th October 1977:
http://www.taintedblood.info/tlfiles/UKHCD 24 October 1977.pdf
Type: Minutes of the 8th Meeting of the United Kingdom Haemophilia Centre Directors. Oxford, 24th October 1977.
Location: Scotland
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1977, 25 October - DHSS
DHSS accepts the principle of phased redevelopment of BPL, but current spending restrictions do not favour the expensive rebuilding as yet.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Statement
Location: UK
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1977, December - "Trends"
"Trends" report recommends 50m iu Factor VIII production.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Report
Location: UK
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1977, December - MRC - Professor Cedric Mims / Professor Peter Wildy - Virologists
Two virologists, Professor Cedric Mims of Guy's Hospital and Professor Peter Wildy of Cambridge University, are consulted by the MRC, but not until December 1977. Professor Wildy replies: "Any clinician who uses growth hormone must be made aware of the gruesome possibilities and their imponderable probabilities."
Source: Clare Dyer, Legal Correspondent, British Medical Journal, 1996:313:185 (27 July)
http://bmj.bmjjournals.com/cgi/content/full/313/7051/185?
Type: BMJ Article - Legal - CJD
Location: UK
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1977, December - Working Group Recommends Complete Transfer from the Use of Cryoprecipitate
The Working Group on trends in the demand for blood products confirms estimates 1000 iu per 1000 population pa and recommends complete transfer from the use of cryoprecipitate to fractionated freeze-dried concentrate.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Recommendations. Taken from DoH Self-sufficiency Report
Location: UK
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1978 - Sunday Observer Timeline - Test for Viral Hepatitis in Blood Donors
A test is developed to determine a history of viral hepatitis in blood donors.
Source: Sunday Observer, April 16th 2006
http://observer.guardian.co.uk/focus/story/0,,1754868,00.html
Type: Press timeline
Location: UK
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1978 - Lancet report
The Lancet publishes evidence that the unidentified virus 'might be more serious than previously thought.'
Type: Lancet report
Location: UK
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1978 - Baxter, Cutter, Alpha - Prevalence of Hepatitis B - Immunoglobulin
Baxter, Cutter and Alpha allegedly begin targeting homosexual donors in known urban gay communities. Urban homosexuals had been reported in the 1970's to have exceptionally high prevalence of Hepatitis B infection. The US pharmaceuticals allegedly know that such donors would provide a reliable source of plasma for the manufacture of commercially valuable Hepatitis B Immunoglobulin (HBIG).
Source: MDL 986 Class Action Plaintiffs Complaint (2004) LCHB, LLP Page 18
Type: Legal document (complaint)
Location: USA
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1978 - New Hepatitis B Core (HBc) Test
By no later than 1978, the US Pharmaceuticals allegedly know of the availability of a new Hepatitis B Core (HBc) test that can determine whether an individual has a history of viral Hepatitis, which would disqualify the donor from providing plasma for the manufacture of Factor VIII or IX.
Source: MDL 986 Class Action Plaintiffs' Complaint (2004) LCHB, LLP Page 18
Type: Legal document (complaint)
Location: USA
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1978 - Lister Institute of Preventative Medicine, Elstree - Closure
Lister Institute Laboratory at Elstree closes due to repeated annual deficits coupled with the need for major expenditure in order to modernise the production facilities.

The Institutes' list of achievements are unprecedented in the field of medical science.

Source: http://www.lister-institute.org.uk/scientificmore.htm
Type: Historical statement
Location: UK
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1978, 14 March - Medicines Division - Premature Discussion of the Export of UK Blood Products
In a Medicines Division (DHSS) circular of March 1978, we are surprised to read of attempts from commercial companies, such as Cutter Laboratories, to market through the UK private sector blood products which have been manufactured from raw materials obtained in the UK and Europe:

"A final possibility is that, since the blood products would be emanating from the U.K. they would carry the cache of our good manufacturing practice. No product licence is required for the export of blood (unlike immunological products) but this subtle distinction between the holding of a manufacturers licence and the holding of a product licence would doubtless be missed by the purchaser overseas." (point C, line 3)

"It is my own view that assuming the company elect to go for the manufacture of blood products within the UK followed by export one should make it clear that inspection of the premises established in the UK would be very likely combined with inspection of the premises from which blood was obtained since these are part and parcel of the whole operation. This would certainly be so if product licenses were involved since blood as a raw material is caught under S.I. 1971 No. 1200." (page 2, lines 6-12)

"If this produces alarm and despondency in the hearts of Cutter Laboratories then it would appear that my suspicions are not unfounded and that the firm are trying to dodge tighter requirements in the interests of making a PROFIT disregarding safety." (page 2, from line 12)

Note: What on earth were Medicines Division doing even considering the exportation of blood products overseas when the UK hadn't got anywhere near enough for their own haemophiliacs? This is hard to comprehend in light of the DOH press release of April 1976 where they re-affirmed the aim of the UK to become self-sufficient in the supply of blood products by mid-1977. (see related entries link below)

It's a great shame the DHSS couldn't have concentrated on getting the UK self-sufficient before looking into the idea of exporting blood products.

Source: http://www.taintedblood.info/tlfiles/Medicines Division on Cutter Laboratories 14 March 1978.pdf
Type: Medicines Division Circular, Room 212, F.S.H. Dated 14th March 1978
Location: UK
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1978, 16 September - Prof. FE Preston
Prof. Preston reports in the Lancet that studies at Sheffield are showing a high incidence of chronic liver disease probably related to the use of concentrate. Hepatitis B is not the only factor.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Lancet report
Location: UK
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1978, 26 September - MHRA / Common Services Agency (CSA) - Product Licence
The MHRA grants a product licence to the Common Services Agency (CSA) for Factor VIII (PL 03473/0007 HUMAN ANTIHAEMOPHILIC FRACTION
Source: Medicines and Healthcare Regulatory Agency (MHRA) Marketing Authorisation, Product Licences for Clotting Factors Granted 1974-1978.
http://www.taintedblood.info/tlfiles/MHRA Licences.pdf
Type: MHRA Licence
Location: UK
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1978, 1 October - North West Thames RHA
North West Thames Regional Health Authority takes over joint management of BPL. There is a change of Director and plans are initiated to buy BPL site.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Plans
Location: UK
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1978, 20 November - Haemophilia Centre Directors' Hepatitis Working Party - Armour Batch R8212
In November 1978, a batch of Armour 'Factorate' is associated with 3 cases of Hepatitis in persons with haemophilia who had received treatment from concentrates:

"The Working Party has been informed of 3 cases of hepatitis in haemophiliacs who had previously received treatment with concentrates which included (amongst others) Armour "Factorate" Batch R8212."

Source: Hepatitis Working Party. 20th November 1978:
http://www.taintedblood.info/tlfiles/Oxford Haemophilia Hep Working Party November 1978.pdf
Type: Recovered Document - Letter from Oxford Haemophilia Centre Re: Hepatitis Working Party. 20th November 1978
Location: UK
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1979 - Article - Lee CA, Webster A, Griffiths PD, Kernoff PBA
The first haemophiliac HIV seroconversion is detected in the United Kingdom.
Source: Lee CA, Webster A, Griffiths PD, Kernoff PBA. Symptomless HIV infection after more than ten years [letter].
Lancet 1990 335: 426 and BMJ 2005, 997-998 (29 October 2005).
http://www.bmj.com/cgi/content/full/331/7523/997?rss
Type: BMJ article
Location: UK
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1979, 7 February - MRC / Dr Craske - Non-A Non-B Hepatitis in Chimpanzees
In a letter of February 1979 from the Medical Research Council to Dr Craske of the PHLS, it is clear that some batches of commercial product containing Factor IX have been found to transmit non-A non-B hepatitis (NANBH) to chimpanzees:

"The non-A non-B agent has not yet been purified from the livers of infected individuals or animals, or from the stool."

"Most recently it has been reported that the non-A non-B agent has been transmitted to chimpanzees. There is a preliminary report that the non-A, non-B agent has been visualized by electron microscopy in the livers of chimpanzees. This, however, needs further documentation. While the chimpanzee is a clumsy experimental animal, this will provide new opportunities for characterization of the agent."

Note: It is disconcerting to read of such a lack of respect for research animals that would eventually give their lives to such experiments. Also, in such a context, it is worrying to see mention of the livers of "individuals" ploughed straight into in the same sentence as "animals" or "from the stool".

Source: http://www.taintedblood.info/tlfiles/MRC NANBH Chimpanzees 7 Feb 1979.pdf
Type: Recovered Document - Medical Research Council. Letter to Dr J. Craske, PHLS. Dated 7th February 1979.
Location: UK
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1979, 12 February - Medical Research Council - Expense and Limited Availability of Chimpanzees
In the minutes of a February 1979 meeting of the MRC, the following is stated concerning the cost and availability of chimpanzees:

"He felt that, at present, chimpanzees were the only possible source of reliable antigens and antisera. These animals were, however, expensive, their supply was limited, and maintenance costs were high." (Page 2, Paragraph 5)

"[Deleted Name] pointed out that it remained uncertain whether non-A non-B hepatitis virus was present in the British population and asked whether blood products of British origin were causing non-A, non-B hepatitis." (Page 3, paragraph 3)

Note: On the last page, reference is made to how few infections British Blood was causing. This clearly shows why self-sufficiency should have been achieved. The bottom line is that we all know how research is the only way to progress with any Public Health safety issue, but if the will and money had been made available, we could have achieved the same information via British donations and reduced total infections by at least 80%.

Source: http://www.taintedblood.info/tlfiles/MRC Minutes Chimpanzees 1979.pdf
Type: Recovered Document - MRC Medical Research Council Meeting Minutes. Dated 12th February 1979
Location: UK
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1979, 3 May - Election: Change of Government - Change of Ministers
The Conservatives gain power with Margaret Thatcher as Prime Minister.

Patrick Jenkin is appointed Secretary of State for Health and Social Services on 5 May.

Gerald Vaughan is appointed Minister for Health in 1979 at the DHSS.

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1979, 14 May - PHLS Suggestion to Use Hepatitis-Implicated Factor VIII in the Treloar School
In a letter to the PHLS from Dr A. Aronstam of the Lord Mayor Treloar Hospital, it is clear in May 1979, that there is an intention from the Public Health Laboratory Service (PHLS) of transfusing mild haemophiliacs with a questionable Factor VIII 'material' which would have caused mild haemophiliac patients to develop hepatitis.

Dr Aronstam strongly disagrees with the PHLS suggestion:

"We have not had any cases of hepatitis following N.H.S. Factor VIII. As far as your suggestion about transfusing mild haemophiliacs with this material is concerned, I totally disagree with this concept. I do not wish any of my mild haemophiliacs to develop hepatitis in any form and therefore adopt the policy of either using D.D.A.V.P. or Cryoprecipitate."

Note: It should be pointed out that the Lord Mayor Treloar College was in fact a boarding school for children. It is disturbing to read that the PHLS were trying to persuade the school to adopt some other type of Factor VIII material which would have caused the pupils to develop hepatitis.

What on earth was the PHLS doing contacting a school to 'promote' hazardous medicines?

Source: http://www.taintedblood.info/tlfiles/Treloar Haemophilia Centre Dr Aronstam 14 May 1979.pdf
Type: Recovered Document - Letter to PHLS from Dr A Aronstam of the Lord Mayor Treloar Hospital. Dated 14th May 1979
Location: UK
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1979, 13 June - MHRA / Armour Product Licence
The MHRA grants Armour Pharmaceuticals Co Ltd a product licence for Factor VIII (PL 00231/0044 HIGH POTENCY FACTORATE PFR).
Source: Medicines and Healthcare Regulatory Agency (MHRA) Marketing Authorisation, Product Licences for Clotting Factors Granted 1974-1978.
http://www.taintedblood.info/tlfiles/MHRA Licences.pdf
Type: MHRA Licence
Location: USA
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1979, 16 July - MHRA / Common Services Agency (CSA)
The MHRA grants a product licence to the Common Services Agency (CSA) for Factor IX (PL 03473/0008 HUMAN FACTOR IX CONCENTRATE POWDER (HTDEFIX) FRACTION.
Source: Medicines and Healthcare Regulatory Agency (MHRA) Licence:
http://www.taintedblood.info/tlfiles/MHRA Licences.pdf
Type: MHRA Licence. Marketing Authorisation, Product Licences for Clotting Factors Granted 1974-1978.
Location: Scotland
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1979, 23 July - Medicines Inspectorate Report
Medicines Inspectorate inspection report published on plasma fractionation facilities at BPL recommending a set of actions that should take place immediately, and others that should be implemented in the long term.
Source: Holgate JA. Medicines Division. Report of inspection of the Blood Products.
Type: Report
Location: UK
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1979, 10 September - Medicines Inspectorate Report
Medicines Inspectorate reports on BPL: more investment is needed; there should be no increase in production until essential steps are taken to improved safety.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Report
Location: UK
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1979, 10 September - MHRA / Alpha Product Licence
The MHRA grants a product licence to Alpha Therapeutic GMBH, Langen, Germany for Factor VIII (PL 04029/0001 PROFILATE INJECTION).
Source: Medicines and Healthcare Regulatory Agency (MHRA) Marketing Authorisation, Product Licences for Clotting Factors Granted 1974-1978.
http://www.taintedblood.info/tlfiles/MHRA Licences.pdf
Type: MHRA Licence
Location: Germany
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1980 - Dr. Edward Shanbrom - Solvent Detergent Patent
Dr. Edward Shanbrom, a former Baxter scientist, receives a patent for a solvent detergent treatment process for viral inactivation of factor concentrate. He approaches all 4 US pharmaceuticals about implementing the solvent detergent method, however all 4 companies refuse to implement the method.

Dr. Shanbrom describes the implementation of this process to be "as easy as washing your hands."

Source: MDL 986 Class Action Plaintiffs’ Complaint (2004) LCHB, LLP. Page 20
(Factual Allegations by U.S. Hemophilia Victims, paragraph 2)
http://www.hemophilia-litigation.com/american-hcv-claims.htm
Additional Source: Douglas Starr:
Type: Patent Solvent Detergent Process
Location: USA
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1980, onwards - BPL - Crown Immunity - Incapable of Meeting Requirements of Medicines Act
Since 1980, it is clear that BPL is not capable of meeting the requirements of the Medicines Act 1968 and is actually relying on Crown Immunity to stay in operation.
Source: Self-Sufficiency in Blood Products in England and Wales: A Chronology from 1973 to 1991, page 25.
Type: Report
Location: UK
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1980, 1 January - Dr. Craske - PHLS - Contaminated Batches of Factor VIII
The following statement reveals that physicians knew in 1984 that HTLV-III (HIV) had infected patients from as early as 1st January 1980:

"Some patients who have received commercial factor VIII since 1.1.80 will already have contracted HTLV-3 infection from other infected batches."

Source: Dr Craske. Public Health Laboratory Service. Page 2, letter dated 23, October 1984.
http://www.taintedblood.info/files/Public%20Health%20Laboratory%20Letter.pdf
Type: Letter - PHLS - Contaminated Batches
Location: UK
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1980 - MRC - Human Growth Hormone and Pituitaries
The MRC no longer has the responsibility for collecting and processing pituitaries as of 1980.
Source: Clare Dyer, Legal Correspondent, British Medical Journal, 1996:313:185 (27 July)
http://bmj.bmjjournals.com/cgi/content/full/313/7051/185?
Type: BMJ Article - Legal - CJD
Location: UK
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1980 - RCMP Investigation into Cryosan - Blood Extracted from Russian Cadavers
Following an investigation by Royal Canadian Mounted Police into the practices of Continental Pharma Cryosan, the blood broker pleads guilty in 1980 for falsely re-labelling blood intended for human beings as originating from donors in Sweden when in fact the plasma had actually been extracted from cadavers (dead bodies) of people in Russia.

Here's a quick summary of the main aspects of our concerns about Cryosan:

  • Cryosan Ltd., a blood-broker, obtained blood from Russian cadavers [1]
  • They re-labelled the blood as having originated from Swedish donors [1,12]
  • Cryosan Ltd. repackaged out-of-date blood & exported it to Europe [13,16]
  • They ran a 'vampire operation' in Bogata & sourced from Haitian slums [12,13]
  • Cryosan Ltd. also shipped contaminated Arkansas prison blood [12,19,21]
  • Cryosan pleaded guilty to false re-labelling and was fined in 1980 [1,13]
  • Cryosan shipped huge quantities of plasma to Travenol in Belgium [14,15,17]
  • Over 11 million i.u. of Travenol's Hemofil and Interhem Factor VIII were imported into the United Kingdom between 1980 and 1981 [18]

NOTE: Taintedblood would like to know the exact origin of the source-plasma for this factor VIII...

Numbered sources listed above are available from the following link: Cadaver Blood - Clotting Factors from the Dead

Source: Excerpts from Murray Dobbin: Paul Martin: CEO for Canada? . 2003. Pgs 26-35.
Additional Source: Western Standard. CA., Friday, May 13, 2005 (para. 27)
http://westernstandard.blogs.com/shotgun/2005/05/paul_martins_gh.html
Type: RCMP Investigation
Location: Canada
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1980 - Medical Research Council - Royal Free Hospital - Hepatitis Study
In the first minutes of the Medical Research Council (MRC) in February 1980, the problems of non-A non-B hepatitis (NANBH) are discussed:

"There was a problem of non-A, non-B hepatitis related to freeze-dried factor VIII and IX, both of NHS and commercial types imported from Austria and the USA. ...[Deleted name] described a recent study at the Royal Free Hospital of 11 selected patients of whom 8 received commercial concentrate, 2 NHS concentrate, and 1 cryoprecipitate." (page 2, paragraph 4, lines 1-6)

"Experiments so far showed that there were probably 2 types of non-A, non-B hepatitis associated with factor VIII. The second type had been produced by the same batch of 'HEMOFIL' which was associated with the Bournemouth outbreak in 1974." (Page 3, point 4)

Note: These minutes also show that Factor IX was being made by Immuno Ltd. in Austria; which would therefore constitute a commercial import with regards to Factor IX. (Page 3, point 3.4)

Source: Medical Research Council (MRC) Minutes 14 February 1980:
http://www.taintedblood.info/tlfiles/Medical Research Council Minutes 1980.pdf
Type: Recovered Document - Medical Research Council (MRC) Minutes 14 February 1980
Location: UK
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1980-81 - Brands of Factor VIII Concentrate Used in UK Haemophiliacs in 1980-81
The following list shows the brands and trade names of Factor VIII concentrate used by UK haemophiliacs in 1980 and 1981 (breakdown by manufacturer):

Manufacturer Trade Name
Abbott Profilate
Armour Factorate
Cutter Koate
Hyland Hemofil
Immuno Kryobulin
Speywood Humanate
Hyland Interhem

Note: We would like to draw attention to the fact that the Immuno is listed here as manufacturing a Factor VIII product under the trade name Kryobulin. As we are aware that Immuno Ltd. was a commercial company, we can safely describe 'Kryobulin' as a commercial product. (See the additional source and the related entries link below).

Source: http://www.taintedblood.info/tlfiles/Brands of Concentrates Used in UK in 1980 and 1981.pdf
Additional Source:
http://www.taintedblood.info/tlfiles/Medical Research Council Minutes 1980.pdf
Type: Breakdown of Brands of Factor VIII Concentrate Used in UK Haemophiliacs in 1980-81
Location: UK
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1980 - Dr Alan Dickinson - Human Growth Hormone - Pituitaries
From 1980, the use of growth hormone from pituitaries of cases with dementia is now excluded.
Source: Clare Dyer, Legal Correspondent, British Medical Journal, 1996:313:185 (27 July)
http://bmj.bmjjournals.com/cgi/content/full/313/7051/185?
Type: BMJ Article - Legal - CJD
Location: UK
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1980 (early) - Blood Products Begin to be Heat-Treated
Blood products begin to be heat-treated; however, yield is very low and not shown subsequently to inactivate NANBH.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Development. Taken from DOH Self-sufficiency Report
Location: UK
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1980 - Mr Martin Flannery, MP & Sir George Young, Under Secretary of State for Health
In a Parliamentary debate, Mr Martin Flannery, MP states regarding BPL Elstree:
"It is a tragedy and a disgrace that under-investment and diffused administration have combined to create a situation whereby the facility have not kept up with technological advances".

The Under Secretary of State for Health, Sir George Young, responds: "The laboratory at Elstree was not designed to meet today's standards of pharmaceutical manufacturing".

Source: Mr Martin Flannery, MP & Sir George Young, Under Secretary of State for Health. Parliamentary Debate, 1980
Type: House of Commons Hansard Debate, 1980
Location: UK
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1980 - NHS Transfusions - Prison Blood
Blood from Scottish prisoners is used in NHS transfusions despite serious concerns that the practice is unsafe.
Source: The Sunday Herald, Liam McDougall, Home Affairs Editor, 23 January 2005
http://news.bbc.co.uk/1/hi/scotland/4201253.stm
Type: Action - Press
Location: Scotland
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1980, March - European Directive - Liability for Defective Products - Factor Concentrates
In a document outlining a proposal to exclude the Transfusion Service from strict liability for the adverse effects of its products, the following statement is made:

"It is vital to recognise that these products carry an inherent risk for the recipient which is quite independent of any system of quality control of the manufacturing process. The acceptability of this risk is the basis of modern, life-support therapy, which enables doctors to treat previously fatal conditions."

In the case of the use of imported commercial blood products the source plasma was not given freely, but paid for, so physicians and the Blood Transfusion Service could not enjoy their usual exclusion from any liability. Also, consultants who were using the commercial Factor VIII concentrates were able to by-pass the public bodies set up to protect the patient.

Note: In trials involving infrequently treated patients, doctors could loose their protection under the rules of "Life-support therapy" if the majority of the patients included were not severe haemophiliacs.

Background: When a doctor treats a patient (without consultation) on the basis that they meet the criteria of research such as previously untreated patients "PUPs", we would suggest that they contradict, or even compromise their Hippocratic Oath by letting the research dictate clinical need.

Source: European Directive on Liability for Defective Products:
http://www.taintedblood.info/tlfiles/European Directive Note Liability 1980.pdf
Type: Recovered Document - Proposal - European Directive on Liability for Defective Products
Location: UK
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1980, 3 March - DHSS - Question of Use of Foreign Plasma Within UK Processing Plants
In the minutes of a DHSS meeting of March 1980, attended, inter alia, by Dr Diana Walford, Dr R. S. Lane, Dr G H Tovey and Dr H H Gunson, we are concerned to read of plans for the possible use of imported plasma from paid donors within UK plants:

"On the question of the use of foreign plasma members agreed that because of the risk of contamination, imported plasma from paid donors should not be processed in [the] same plant as UK plasma. However, if industry were to function at ECONOMICAL capacity there might be no alternative but to allow it to fractionate imported plasma from overseas unpaid donors such as that which might be provided by voluntary transfusion services."

"The two types of plasma and finished product would have to be kept separate at all stages and there might have to be separate quality control arrangements. It was thought that monitoring such an arrangement would not be easy." (page 3, paragraph 5)

Note: These comments make it abundantly clear exactly how much the DHSS knew about the risk of contamination from imported plasma from paid donors. They knew about the risks in 1980. In fact, we know that they were warned in January 1975 about the dangers of sourcing commercial blood from paid donors. Now we have it documented, complete with names of attendees, that they knew for sure in 1980 - so there should be no more denials and pathetic statements about 'no wrongful practices' and no more excuses about being caught unawares by the ensuing AIDS crisis.

Under the heading 'Technology' on page 2, we learn of further evidence of an early awareness of the possibility of genetic engineering: "The method of fractionation should be negotiable; (in 5-8 years' time, fractionation by genetic engineering could be the more effective technology.)"

Note: It never ceases to amaze us as to exactly how far back in time the awareness within industry and the DHSS of the process of genetic engineering of synthetic factor concentrates actually goes. We are now able to trace this knowledge right back to March 1980.

Source: http://www.taintedblood.info/tlfiles/DHSS Minutes with Names Visible 3 March 1980.pdf
Original Source: DOH website FOI Volume 71 (pgs 59-62):
http://www.dh.gov.uk/prod_consum_dh/idcplg?IdcService=GET_FILE&dID=150778&Rendition=Web
Type: Minutes of a Meeting of the DHSS at Hannibal House. Date 3rd March 1980.
Location: UK
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1980, 1 May - Dr Lane - BPL State of Deterioration - Implications on Rate of Demand for Factor VIII
BPL is in a state of deterioration and has not expanded since 1977. This has implications on the ever-increasing rate of demand for Factor VIII blood products. If BPL fails to satisfy some of this demand, then products will have to be imported which is likely to cost in excess of 30m based on estimates of the cost of importing just 2 products at today's prices.
Source: Letter dated 1 May 1980, from Dr Lane to Dr Harris of the Dept. of Health.
Type: Letter
Location: UK
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1980, 4 July - Poor Condition of BPL, Elstree - Overseas Plants in even Worse Condition
In a letter dated 4th July, 1980, the condition and low morale of staff at the Blood Products Laboratory, Elstree is discussed:

"The alternative will then be to import NHS requirements if such supplies are indeed available, and there are also grave doubts whether quality of overseas production will be acceptable. My experience of overseas plants generally leads me to believe that quality standards will be no better than those at BPL. Some of the Elstree staff told us that on recent visits to the USA they had visited fractionation plants in which the manufacturing conditions were worse than those at BPL." (pages 2, paragraph 1)

"The cleaning specifications which we agreed was the best that could be achieved in an unsatisfactory building. It is false and dangerous to imply that the revised cleaning programme has produced a safe system." (page 2, final paragraph)

Source: Response to Draft Submissions, Blood Products Laboratory, Elstree, dated 4th July 1980:
http://www.taintedblood.info/tlfiles/BPL JULY 1980.pdf
Type: Recovered Document - Letter, Blood Products Laboratory, Elstree, dated 4th July 1980.
Location: UK
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1980, August - Short-term Upgrading of BPL - Double Production Capacity ?
Short-term upgrading of facilities at BPL is agreed at cost of 1.3m. This is expected to double production capacity from 15m i.u. per annum.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Agreement
Location: UK
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1980, 15 September - Dr Diana Walford - DHSS: Non-A, Non-B Hepatitis Could be Rapidly Fatal
In a letter of 15 September 1980, Dr Diana Walford, a doctor working for the DHSS, recorded that the majority of the hepatitis infections following blood transfusion or treatment with blood products in the USA (and elsewhere) were caused by non-A, non-B hepatitis (NANBH) and that these viruses could be rapidly fatal.

The following was recorded in writing by Dr Walford in 1980: "I must emphasise that 90% of all post-transfusion (and blood-product infusion) hepatitis in the USA and elsewhere is caused by non-A, non-B hepatitis viruses which (unlike Hepatitis B) cannot, at present, be detected by testing donor blood."

Dr Walford goes on to state: "This form of hepatitis can be rapidly fatal (particularly when acquired by patients with pre-existing liver disease) or can lead to progressive liver damage..."

NOTE: We would like to draw attention to the level of knowledge that the DHSS possessed in 1980. This is the knowledge they had then; the very same information that the haemophiliac community are only discovering now. However, this is not a question of government only having the ability to understand the situation with regard to fatalities from viral hepatitis after they had happened, this letter of 1980 demonstrates full comprehension by the DHSS of the gravamen of such infections from commercial imports. Therefore, we must ask why any preventative action wasn't taken by the DOH and why was it that a complete myth was somehow propagated that NANBH was "mild and often asymptomatic"?

Source: http://www.taintedblood.info/files/1440859186Dr_Diana_Walford_Letter_September_1980.pdf
Type: Dr Diana Walford, MED SM4. Letter to Mr Harley. 15 September 1980
Location: UK
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1980, October - Dr Craske - NANBH is Mild and Often Asymptomatic !
Dr John Craske claims that NANBH (non-A, non-B hepatitis) "is mild and often asymptomatic, but might cause chronic liver disease not associated with overt disease.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Claim
Location: UK
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1980, November - BPL Elstree - Funds Allocated to New Fractionation Facility
21m is allocated to the building of a new fractionation facility on existing site at Elstree.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Allocation
Location: UK
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1980, November - NIBSC - Armour AHF Batch J70902
According to the National Institute for Biological Standards and Control (NIBSC), in November 1980, Armour AHF Batch no. J70902 is reported to have given rise to 3 separate incidents of various types of hepatitis in 3 persons with haemophilia.
Source: SNBTS FVIII Study Group, Meeting Minutes. 30th March 1982. Pages 5-6:
http://www.taintedblood.info/tlfiles/SNBTS Study minutes_fviii_14-10-82.pdf
Type: Library Samples of Armour Batch J70902
Location: UK
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1980, 9 December - BPL Elstree - Medicines Inspectorate report
The Medicines Inspectorate visit BPL Elstree and discover that BPL does not conform to acceptable industry standards. The investigation discovers that:
  • There is mould growing on a glycol line that serves one of the vessels.
  • The cold freezer does not have any kind of temperature recording apparatus.
  • There is water dripping from overhead metal panels and again mould growth is noticeable.
  • There is plaster cracking in many parts of the building, resulting in bits of plaster breaking off.
  • The autoclaves in the autoclave area have not been validated. The necessary commissioning using a multi channel recorder has not been done.
  • In Room 13, paper is taped to improve the wooden benches where Factor 8 initial phase processing chromatographic work is carried out, and there are still openable windows present in what should be an aseptic area used for sterilising solutions.
Source: The National Blood Transfusions Service Joint Management Committee (Dept Of Health Northwest Thames Regional Health Authority for the Central Blood Laboratories)
Type: Inspectorate Findings Report
Location: UK
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1980, 22 December - Professor Zuckerman - World Health Organisation
Professor Zuckerman, from the World Health Organisation (WHO), speaking on ITV's World in Action in 1980: The Blood Business, stated that there was an increase in the occurrence of hepatitis indicated by jaundice amongst haemophilia patients and that he believed that this was due to commercial imports of Factor VIII from Europe and the United States.
Source: Zuckermann A.J. "World In Action" documentary "The Blood Business". ITV, 22 December, 1980:
http://www.taintedblood.info/tlfiles/_World_In_Action_22_Dec_1980.pdf
(16 pages, 3.66MB)
Type: Statement: Transcript of "World in Action" - ITV - 22 December, 1980.
Location: UK
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1980, 22 December - Dr Peter Jones / Dr David Owen - World in Action - Underfunding of BPL
The condition and lack of funding of BPL Elstree is discussed at length in ITV's World in Action in December 1980. The following comments are particularly worth noting:

Dr David Owen MP, then Minister of Health acknowledges that no government has put enough money in to BPL: "Well, I don't think we've invested enough. I thought then, on the best evidence that I had, I think it was 500,000 that we found, was going to be sufficient. But what has happened is that although we have increased, as I gather at production, demand increased as well. I left, ceased to be Minister of Health and went to the Foreign Office in 1976, but I think what has been needed is a steady investment, and not just into Blood Products Laboratory, but also into the regional blood transfusion services which have been starved of money." (page 2, paragraph 4)

Dr Peter Jones: "What should have been put in is something more in the region of 25 million..." (page 4, paragraph 2)

Reporter [with reference to hepatitis]: "Research has shown that haemophiliacs are TEN times more likely to contract the disease if they use commercial imports, rather than National Health Service material." (page 11, paragraph 6)

Reporter's Closing Comment: "The Department says there's no money available. That means hospitals will spend millions more on imports, patients will risk the consequences of skid row blood and Britain will become increasingly dependent on the world blood market." (page 16)

Source: http://www.taintedblood.info/tlfiles/_World_In_Action_22_Dec_1980.pdf
(16 pages, 3.66MB)
Type: Recovered Document - Transcript of World in Action - ITV - 22 December, 1980
Location: UK
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1981 - Her Majesty's Inspectorate - Damning Report of BPL, Elstree
Following visits in 1979 and 1980 by Her Majesties Inspectors, a damming report declares BPL to be unfit for the good pharmaceutical manufacturing practice under the provisions of the Medicines Act 1968. As a result of failure in Duty of Care and breach of statutory duties, there was a significant delay in the introduction of a system to pasteurise Factor VIII by heat treatment, thus directly leading to many haemophiliacs becoming infected with Hepatitis C.
Source: The National Blood Transfusions Service Joint Management Committee (Dept Of Health Northwest Thames Regional Health Authority for the Central Blood Laboratories)
Type: Official Report (on BPL)
Location: UK
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circa 1981 - NBTS - Developments in Genetic Manipulation & Recombinant DNA Techniques
In a 1981 report of the NBTS Protein Fractionation Technology Working Party, we read of scientific advances in the manipulation of genetic material that led to technological developments introducing the possibility of large-scale production of proteins [of which Factor VIII is one] for therapeutic use from bacteria or from animal cells cultured in vitro [in the test tube or Petri dish].

There have been two major lines of work toward this end: "One has drawn on recombinant DNA techniques to construct bacteria capable of producing "human proteins". The alternative has been to change the characteristics of animal, including human, cells to make them more amenable to large-scale cultivation in vitro.

We are not surprised to see what criteria the NBTS PFT Working Party use to decide whether or not to implement genetic manipulation techniques:

"It is necessary to decide whether the principal plasma proteins could be generally available at a competitive cost and of proven safety in a time-scale which bears upon the development of BPL. If so it is important to decide whether the technology arising from genetic manipulation is one which BPL would logically become engaged in." (page 27, para 3)

"Given prompt action on the redevelopment of conventional fractionation facilities, the return on investment will have been achieved before genetically engineered products can have a major impact. Nevertheless failure to take account of them may lead to a crisis shortly after the new plant has commenced operation." (page 30, final para)

Note: From 1981, it took 13 years for recombinant clotting factors to be licensed for use within the UK (i.e. in 1994). We believe that this could have been done in far less time, like Hyland, who were running human clinical trials of their recombinant in 1987. We would also like to point out that it took Government until 2006 to fully 'roll-out' recombinant factor concentrate to all adult haemophiliacs across the UK.

From 1981, that's a grand total of 25 years of deferment.

Source: NBTS PFTWP Report 1981, Appendix 8, pgs 27-30.
http://www.taintedblood.info/tlfiles/NBTS PFT Working Party 1981.pdf
Type: National Blood Transfusion Service - Protein Fractionation Technology Working Party Report 1981
Location: UK
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1981, circa January - Sir George Young, Under Secretary of State - Warning over Hepatitis Risk
Sometime in January 1981, Sir George Young, Under Secretary of State in the Department of Health, gives a warning of the "possible risks of hepatitis" from imported products, particularly from those made from plasma supplied by paid donors.

Sir George Young's warning was reported the following month in the Sunday Telegraph (on 01.02.81) in an article entitled: "10 Sick After Factor 8 Doses". The article goes on to say:

"Imports worth an estimated 10 million of Factor 8, the missing factor in a haemophiliac's blood, come from America, Germany and Austria in powdered form to supplement the limited amount made in Britain."

Dr Charles Rizza: "There might be a greater degree of risk from commercial products."

"The National Institute for Biological Standards and Control, [NIBSC] which tests all foreign blood products imported by Britain, rejects a "small amount," believed to be about 5%, of the millions of bottles of Factor 8 brought in each year."

Note: The Under Secretary of State's warning came just one month after the damning Medicines Inspectorate report of the laboratories of BPL Elstree on 9th December 1980 which gives insight into the state of domestic production. This warning over the risks of imported products from paid donors was either ignored or came too late for 10 of the haemophiliac boys attending the Lord Mayor Treloar School in Alton as by the beginning of February, they contract hepatitis from commercial Factor VIII.

They were only children, aged between 9 and 14.

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1981 - Sunday Observer Timeline - CDC Organises Task Force
The US Centre for Disease Control and Prevention organises a task force in response to a disease later called Acquired Immuno Deficiency Syndrome, shortened to AIDS.
Source: Sunday Observer, April 16th 2006
http://observer.guardian.co.uk/focus/story/0,,1754868,00.html
Type: Press timeline
Location: USA
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1981 (Mid) - NBTS Advisory Committee - Demand for Factor VIII will Increase
The Advisory Committee to the NBTS estimates that demand for factor VIII will increase to 100m i.u. per annum by mid-1980s. Regional targets for plasma are set.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006).
Type: Estimates statements
Location: UK
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1981 - SNBTS Minutes - Blood taken from American Troops Stationed in UK
Confidential minutes from meetings held by directors of Scottish National Blood Transfusion Service show increasing quantities of blood taken from American troops stationed in UK.

Note:
In the USA, blood collectors refuse to take blood donations from GI's until at least 2 years have elapsed since visiting the Far East and then only after blood tests have been completed.

Source: The Sunday Herald, Liam McDougall, Home Affairs Editor, 23 January 2005
http://www.sundayherald.com/47265
Type: Minutes
Location: Scotland
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1981, circa February - Behringwerke AG (German blood product manufacturer)
A pasteurization procedure is developed and licensed in Germany by blood product manufacturer Behringwerke AG. It involves heating factor concentrates at 60C for ten hours. An article demonstrating the efficacy of the pasteurization process is published the same year.

Note: Other manufacturers are reluctant to adopt this technique over concerns regarding:

  • 50-90% loss of yield,
  • factor supply could be in jeopardy
  • pasteurized factor will cost ten times more
  • concerns over the effectiveness of inactivating non-A non-B hepatitis
  • patients might develop inhibitors.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 754.
Additional Source: NEJM, Vol 316, No 15 pps 918 - 922.
Type: Pasteurisation procedure licensed
Location: Germany / USA
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1981, 1 February - Treloar School Alton - 10 Children Contract Hepatitis from Commercial Factor VIII
UK Health ministers are warned about the dangers of importing contaminated blood products from the United States:

In February 1981, 10 children at the Treloar specialist school in Alton, Hampshire are infected with hepatitis from contaminated Factor VIII in what we believe to be a second outbreak of hepatitis B. There then follows a warning regarding infected Factor VIII supplies being imported from the USA.

The Department of Health admitted at the time that they knew there was a risk of infection and the then Health Minister, Dr Gerard Vaughan, claimed that the 1.29m being invested in the BPL Elstree would resolve the problem.

Note: We have to wonder if this second outbreak of hepatitis was as a direct consequence of an approach made by the Public Health Laboratory Service (PHLS) two years earlier on 14th May 1979? We can determine from documentation that there was the intention from the PHLS of transfusing mild haemophiliacs with a Factor VIII 'material' which would have caused mild haemophiliac children to go on to develop hepatitis.

In a reply letter of May 1979 to the PHLS from Dr A. Aronstam of the Lord Mayor Treloar Hospital, we read that Dr Aronstam totally disagreed with the PHLS' suggested concept and he adamantly stated that he did not wish any of his mild haemophiliacs to develop hepatitis in any form.

Source: http://www.taintedblood.info/tlfiles/Guardian 1983 Andrew Veitch Medical Correspondent.pdf
Additional Source:
http://www.slowlyslowlycatchymonkey.com/Ten_Sick_after_Factor_8_doses.pdf
Type: Guardian Article, Circa 1983. Extra 30m could have kept out AIDS. Andrew Veitch Medical Correspondent
Location: UK
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1981, April - Conrad Article - Diseases Transmissible by Blood Products
According to the Chronology in the Haemophilia HIV Litigation "Advice on Settlement" document, in April 1981, the Conrad article discussed "the various viruses transmissible by blood products, including exotic ones."

Note: We believe this article to be Conrad ME. Diseases transmissible by blood transfusion: viral hepatitis and other infectious disorders. Semin Hematol 1981; 18:12246.

Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Article
Location: UK
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1981, 1 April - BPL - Pro Rata Distribution of Products
Regions start to received BPL products relative to the amount of plasma supplied (pro rata distribution).
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Development
Location: UK
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1981, 24 April - Treloar Hospital - Pro Rata Distribution of Blood Products
In a circular of 24 April 1981, a meeting of Regional Treasurers on 3 September 1980 is referred to where a discussion takes place regarding the Department's intention to introduce a pro rata distribution of certain blood products from 1 April 1981:

Factor VIII: "It has been decided to make special arrangements for one unit only - the Lord Mayor Treloar Hospital in Wessex whose residential 'school' caters for 40 severe haemophiliac pupils drawn from all over the country. The Hospital will receive an allocation of 300,000 international units of Factor VIII per annum calculated on the basis that the Blood Products Laboratory (BPL) currently produces approximately 7,500 units per severe haemophiliac." (point 2.)

BPL aims initially to return to Regions 80% of the notional gross yield. This equates roughly with the present production levels. The remaining Factor VIII will be used to build up a necessary reserve stock and to meet the allocation for the Lord Mayor Treloar Hospital. (point 3.)

Factor IX: "Treasurers will wish to note that since we are currently self-sufficient in Factor IX and production is expected to keep pace with demand for the foreseeable future, it has been decided to exclude this product from the pro rata system." (point 5.)

Note: This is a useful document for several reasons. Here we have written proof that the Lord Mayor Treloar School was indeed catering for severe haemophiliac pupils, therefore confirming the age-range and we are also given a figure for how many - 40 haemophiliac pupils in 1981.

We are also interested to read that BPL will supply RTCs with certain blood products, such as Factor VIII, by proportional distribution to their input of plasma and that this system excludes Factor IX.

Source: http://www.taintedblood.info/tlfiles/Treloar Factor VIII 24 April 1981.pdf
Type: Circular Ref. Pro Rata Distribution of Blood Products. Dated 24 April 1981
Location: UK
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1981, May - Health Minister, Dr Vaughan is Warned of Danger of Contaminated US Blood Supplies
The Minister for Health, Dr Gerard Vaughan, is warned about the dangers of contaminated blood supplies from the USA.

We know this from an Oral Question raised two years later in Prime Minister's Question Time (3rd May 1983). Mr Race made it clear that Dr Gerard Vaughan, by then former Minister for Health, was warned 2 years earlier, circa May 1981, of the danger of contaminated blood supplies being imported from the USA:

Mr. Race Oral Question, May 1983: "As the House of Commons' favourite own-goal merchant, the Minister for Consumer Affairs, was warned two years ago by his own Department of the danger of contaminated blood supplies coming from the United States, will the Prime Minister rectify that deplorable and disgraceful mistake by immediately authorizing the necessary expenditure within the National Health Service to make Britain independent in its blood supplies?" (see first column, para 9.)

Source: http://www.taintedblood.info/tlfiles/Oral Answer Mr Race and PM 3 May 1983.pdf
Additional source (see para 5)
http://www.taintedblood.info/tlfiles/Health and Social Service Journal May 12 1983.pdf
Type: Oral Answer, Prime Minister's Question Time. 3rd May 1983. Additional Source: Health and Social Services Journal, May 12, 1983. Article by Michael White. (see paragraph 5)
Location: UK
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1981, 5 June - MMWR
Morbidity & Morality Weekly Report (MMWR) publishes first report of the condition which later becomes known as AIDS in an American homosexual men.
Source: Krever Commission Report (1997), Vol 3, Part IV, International Milestones: HIV and AIDS 1981-8.
Type: MMWR report
Location: USA
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1981, 5 June - USA Report
America reports cases of pneumocystis carinii pneumonia in 4 US homosexuals
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Report
Location: USA
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1981, July - BPL
Construction begins on short-term redevelopment of BPL.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Development
Location: UK
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1981, July - CDC Task Force
The CDC creates a task force on Kaposi's sarcoma and opportunistic infections.
Source: Krever Commission Report (1997), Vol 3, Part IV, International Milestones: HIV and AIDS 1981-8.
Type: Development
Location: USA
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1981, 3 July - CDC - Opportunistic Infections - CMV / Hepatitis
The CDC reports unusual and similar immuno-suppressive diseases in 26 homosexuals, noting that all 12 patients tested for cytomegalovirus (CMV) had evidence of "past or present CMV infection", and that past infections with hepatitis "were commonly reported."

The CDC warns doctors to be alert for "opportunistic infections associated with immunosuppression in homosexual men".

Source: MMWR, July 3, 1981, at p. 305 and Id., at p. 307.
Additional Source: MDL 986 Class Action Plaintiffs Complaint (2004) LCHB, LLP. Page 16
Type: Reported findings
Location: USA
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1981, 3 July - USA Report
CDC America, reports on Kaposi's sarcoma, with additional reports of impaired cellular immunity.
Source: MMWR Weekly (1981) Kaposis Sarcoma and Pneumocystis Pneumonia among Homosexual Men - New York City and California, July 4,30 (4); 305-308
Type: CDC Report
Location: USA
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1981, 4 July - BMA Journal
British Medical Journal editorial states that Hepatitis Non-A Non-B is the major cause of chronic liver disease in patients with haemophilia. It points to the dangers of large donor pool sizes.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Editorial Article
Location: UK
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1981, 28 August - Pharmaceutical Companies - Hepatitis - Unsuitable Donors
The reported figures grow to 108 cases and 40% fatalities; 94% of the 101 males were homosexual or bisexual.

Based on this evidence and the high prevalence of hepatitis in the same population, the US Pharmaceuticals (allegedly) should have known by no later than the Summer of 1981 that urban homosexual males were not "suitable donors" within the meaning of federal regulations and/or other applicable standards of care.

Source: MDL 986 Class Action Plaintiffs Complaint (2004) LCHB, LLP. Page 16.
Additional Source: MMWR, August 28, 1981, Id., at p. 409.
Type: Reported Statistics - MMWR
Location: USA
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1981, September - J. B. Brown - Letter to J. Harly - Department of Health
J. B. Brown admits in a letter to Mr J. Harly of the Department of Health that:
"The present facility at Elstree is totally unsuitable for the manufacture of sterile products and incapable of being upgraded to the required standards."
Source: Letter dated September 1981 from J. B. Brown writing to J. Harly, Department of Health
Type: Letter
Location: UK
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1981, 14 September - Government - Change of Minister
Norman Fowler is Secretary of State for Health and Social Services.
Source: Wikipedia Encyclopedia
http://en.wikipedia.org/wiki/Secretary_of_State_for_Health#Secretary_of_State_for_Social_Services
Type: Political climate
Location: UK
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1981, 24 September - Dr J. Craske - Hepatitis Working Party - Non-A Non-B Hepatitis
In the minutes of the Hepatitis Working Party for 1980-81, Dr J. Craske records the following:

"Table (2) compares the figures for B and non-B hepatitis in patients receiving only one product in any year for the years 1977-9 and was presented in last years report."

"It shows that there is a 4-20 times higher incidence of overt non-A, non-B hepatitis associated with U.S. Commercial concentrate compared with NHS." (see Page 1, under A: 'Incidence of Hepatitis due to commercial versus NHS associated hepatitis')

Source: UK Haemophilia Centre Directors' Hepatitis Working Party, Minutes 1980-1981:
http://www.taintedblood.info/tlfiles/HCD HWP 1980 to 1981.pdf
Type: Minutes - HCD Hepatitis Working Party. Minutes 1980-1981.
Location: USA
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1981, 24 September - Dr Craske, Manchester - PHLS
The only way that infectivity for Non-A Non-B hepatitis can be shown (other than human inoculation) is by inoculation in chimpanzees. Since very few of these animals are available, it is difficult to see how every batch treated by this method will have quality control assurance with respect to Non-A Non-B viruses.
Source: Dr Craske. UK Haemophilia Centre Directors' Hepatitis Working Party, Minutes. 24 September 1981:
http://www.taintedblood.info/tlfiles/Haemophilia Centre Directors Hepatitis Working Party Report 1980-1981.pdf
Type: Statement
Location: UK
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1981, 30 September - BPL Policy Steering Group - Manufacture of Products by Genetic Engineering
In an supplementary page (agenda item 3a) of the minutes of the Policy Steering Group for the Redevelopment of BPL in September 1981, we read about whether the redevelopment of BPL would be permitted to produce genetically engineered material in direct competition with Industry.

Manufacture of Products by Genetic Engineering

"At the last meeting of the PSG it was asked whether the redevelopment of BPL would be permitted to produce genetically engineered material in direct competition with Industry."

"As a general principle Ministers are not in favour of NHS facilities engaging in activities which Industry is competent to perform. This does not preclude involvement in product development but, with certain exceptions (eg products derived from human substances) manufacture of products which are or will be available commercially is difficult to justify."

Source: BPL Policy Steering Group PSG 81-10
http://www.taintedblood.info/tlfiles/BPL Policy Steering Group 30 Sept 1981.pdf
Type: Policy Steering Group for the Redevelopment of BPL - Agenda Item 3a. Date of connecting Minutes 30 September 1981.
Location: UK
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1981 (late) - BPL / Department of Health - Heat-Treatment Operation
Following the highly critical report of Her Majesty's Inspectors, plans are drawn up that specifically include a heat-treatment operation for the inactivation of Non-A Non-B hepatitis.

The Government is slow to implement these plans.

Type: Plans
Location: UK
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1981, 30 October - Dr Gerard Vaughan - Extent of NHS Reliance on Commercial Factor VIII
In a DHSS letter from Dr Gerard Vaughan, Minister for Health, to the Chairman of the Haemophilia Society in October 1981, we read about the extent to which the NHS is relying upon commercial blood products:

Dr Gerard Vaughan: "I appreciate your Society's concern about the extent to which the NHS relies upon commercial blood products. As I told you, the upgrading programme being carried out at the Blood Products Laboratory at Elstree will, at present yields, enable the Laboratory to double its output of Factor VIII to 30 million international units by the end of 1982."

Dr Gerard Vaughan: "While this will not eliminate the need for commercial products, it represents a major step forward in NHS production of the vital material."

Source: DHSS Letter from the Minister for Health, Dr Gerard Vaughan
http://www.taintedblood.info/tlfiles/Dr Gerard Vaughan DHSS Oct 1981.pdf
Type: Department of Health and Social Security. Letter from the Minister for Health, Dr Gerard Vaughan to the Chairman, Haemophilia Society. Dated 30th October 1981.
Location: UK
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1981, December - Lancet
The Lancet reports first UK case of AIDS in a homosexual.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Lancet Report
Location: UK
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1981, December - New England Journal of Medicine
In December 1981, the New England Journal of Medicine issues a report of AIDS in heterosexual intravenous drug users.
Source: Krever Commission Report (1997), Vol 3, Part IV, International Milestones: HIV and AIDS 1981-8.
Type: Report (NEJM)
Location: USA
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1982 - Dr David Owen - House was Told in 1975 that UK would be Self-sufficient
David Owen: "When I said that we hoped to be self-sufficient in blood products by mid-1977, I was not speaking in the House, so that that statement did not bind successive Governments. But we are all responsible for the two earlier pledges that were given in the House."

"The targets were not achieved and we are still not self-sufficient in blood products. I was told by a Minister of the present Government that they made the decision to be self-sufficient in 1982. Was Baroness Trumpington unaware that the House had already been told in 1975 that Britain would be self-sufficient? What happened? ...."

Source: Commons Hansard - 23 November 1989, Column 272
http://www.publications.parliament.uk/pa/cm198990/cmhansrd/1989-11-23/Debate-5.html
Type: Commons Hansard
Location: UK
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1982 - Hepatitis Working Party
The Hepatitis working party discusses plans for clotting factor products and requests "exemption from a clinical trials certificate in respect of individual products in order to expedite trials".
Source: Bloom AL, Rizza CR. Letter to all Haemophilia Centre Directors. 11 January 1982. Page 2, Paragraph 3.
http://www.taintedblood.info/files/Oxford%20Letter%2011-01-1982.pdf
Type: Discussion
Location: UK
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1982, 11 January - UKHCDO - Request to Commercial Companies
Commercial companies producing blood products are asked to 'offer appropriate supplies as well as financial support'.
Source: Bloom AL, Rizza CR. Letter to all Haemophilia Centre Directors. 11 January 1982. Page 2, Paragraph 3.
http://www.taintedblood.info/files/Oxford%20Letter%2011-01-1982.pdf
Type: Request
Location: UK
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1982, 11 January - Dr A. L. Bloom & Dr C. R. Rizza - Chimpanzees - Studies in Human Beings

Oxford Haemophilia Centre Letter to All Haemophilia Directors:

4 Commercial Companies are about to release Factor VIII & possibly Factor IX products that have been heat-treated in an attempt of reducing the risk of transmitting Hepatitis B and Non-A Non-B hepatitis.

"Infectivity of initial batches is tested by injecting the product into Chimpanzees. However, it is stated that it is unlikely that Manufacturers would be able to ensure this form of quality control in all future batches."

Note: The letter states that it is important to find out in studies of human beings the extent to which infectivity has been reduced.

Use of Previously Untreated Patients (PUPs) that have not previously used concentrates form large donor pools is suggested.

Controlled Studies on a "named patient-basis" is deemed to be undesirable.

Source: Bloom AL, Rizza CR. Letter to all Haemophilia Centre Directors. 11 January 1982.
http://www.taintedblood.info/tlfiles/Oxford Chimpanzee Letter.pdf
Type: Internal letter
Location: UK
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1982, 13 January - BPL
BPL Elstree decides to increase pool size to 7,500 donations.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Decision
Location: UK
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1982, March - CDC Interagency Meeting USA
The CDC convenes its first interagency meeting with the FDA and the National Institutes of Health in an effort to recruit their assistance in laboratory research and investigation of the history and cause of the disease.
Source: Krever Commission Report (1997), Vol 3, Part IV, chap. 27, page 741
Type: Interagency meeting / NIH
Location: USA
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1982, 1 March - NIBSC Leeway in Assaying FVIII Material before Release to Hospitals
In the Minutes of the Fourteenth Meeting of the Haemophilia Reference Centre Directors on Monday 1st March, 1982,

Professor Bloom welcomed Dr. Aronstam to the meeting and said that he felt sure that the Reference Centre Directors would benefit from Dr. Aronstam's special experience of managing adolescent haemophilic boys.

6: "Assays on commercial concentrates"
"Dr. Kernoff said that he thought NIBSC were responsible for checking factor VIII preparation for assaying the material before it was released for use in hospitals throughout the U.K."
"He had therefore heen very surprised by the letter in the Lancet describing discrepancies between the 'labelled' potency and the 'found' proteins. NIBSC allowed 20%-leeway on the assay value of the material."
"He thought that NIBSC should have been the people to have known about the discrepancies and that it should not have been necessary for the discrepancies to have been brought to light by a Haemophilia Centre. There was some discussion about the functions of NIBSC."
Note: It seems that Factor VIII potency was not the only leeway being allowed for by NIBSC. The licensing authority imposes a "batch release" condition on all foreign blood products under which samples must be supplied for initial batch testing by NIBSC. We know that only the year before, it was recorded that NIBSC was only rejecting a small amount (in the region of 5%) of foreign blood products imported into Britain.
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1982, March - CDC Conference
CDC convenes conference on Kaposi's sarcoma and opportunistic infections.
Source: Krever Commission Report (1997), Vol 3, Part IV, International Milestones: HIV and AIDS 1981-8.
Type: Conference
Location: USA
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1982, 5 March - Government - Change of Minister
Kenneth Clarke becomes Minister of State for Health on 5th March 1982, and remains so until September 1985.
Source: Ministerial membership of DHSS 1970-88
http://www.psr.keele.ac.uk/table/york/DHSS.html
Website, The Rt Hon Kenneth Clarke, QC, MP
http://www.nyt.co.uk/kenneth-clarke.htm
Type: Political climate
Location: UK
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1982, 30 March - SNBTS Factor VIII Study Group - Discussion of Humans as Infectivity Study Models
In the meeting Minutes of the SNBTS Factor VIII Study Group of 30 March 1982, the following disturbing discussion takes place regarding infectivity studies:

"The use of animal models for infectivity study purposes was discussed. Chimpanzees would cost 10,000 per animal test per 6 months. If humans were used it would not be possible to have a "known positive" control. The methods of inactivation available were heat treatment; irradiation or absorption." (Page 5, paragraph 1, line 4)

"It was agreed that infectivity was the crucial question and the dilemma over the use of chimps (an endangered species), owl monkeys (information to be supplied by Dr Sommerville when available) and humans formed the basis of a long discussion." (Page 5, paragraph 2, line 7)

Note: It is disconcerting to read of infectivity study models involving human beings. We would have said that the crucial question should have been over the use of humans in infectivity studies. Did they carry this out, or was it just a discussion of what these doctors thought their options were?

Source: http://www.taintedblood.info/tlfiles/Minutes of Factor VIII Study Group 30 March 1982.pdf
Type: Freedom of Information (Scotland) Document. SNBTS Minutes of Factor VIII Study Group. Dated 30th March 1982
Location: Scotland
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1982, 30 March - Factor VIII Study Group - Prospective Trial of First Time Haemophiliacs
In the minutes of the Second Report of the Factor VIII Study Group of 30th March 1982, we read of further discussion of Chimpanzees:

"It is clear that chimpanzees can be used at a much younger age than was previously mentioned (2 yrs vs. 3 years). It is also rumoured that NIH costs (contracted to a colony in U.S.) are lower than those in Liberia." (Page 4, point b)

On page 5, under the heading "Procurement of Infective Material" we read that:

"Various people were contacted in the U.K., but none had much to offer. C. Rizza in conjunction with J. Craske are running a prospective trial of "first time" haemophiliacs receiving NHS and commercial concentrates." (Page 5, point 3.)

Note: We have to ask what the reference to "first time" haemophiliacs really means in practice? We would suggest that in order to meet the criteria for trials such as this, the haemophiliac subjects should not have been exposed to large pool concentrates - which would almost certainly mean that they were either a young child PUPs (Previously Untreated Patients), or moderate to mild haemophiliacs, who were again likely to be children, but might also have been adults.

Source: http://www.taintedblood.info/tlfiles/Second Report of Factor VIII Study Group Liberton 30 March 1982.pdf
Type: Freedom of Information (Scotland) Document - Second Report of Factor VIII Study Group, Safety Action Group Liberton. Dated 30th March 1982.
Location: Scotland
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1982, May - DHSS - Licence of Hepatitis B Vaccine
A vaccine for Hepatitis B is licensed in the United Kingdom. The DHSS decides not to purchase any vaccine centrally, due to insufficient funding. Instead, each Region is to find funds from existing budgets for the purchase of HBV vaccines.

Note:
Perhaps the question should be posed as to whether the medical profession knew that haemophiliacs already had antibodies to Hepatitis B? Yet, the profession's desire to amass research through trials on PUPs (Previously Untreated Patients) prevailed.

Source: Minutes of the 13th Meeting of UKHCDO, University Hall of Residence, Owens Park, Manchester. Monday 13th September 1982. Page 10, paragraph 2.
http://www.taintedblood.info/files/UKHCDO_13_September_1982.pdf
Type: HBV Licence. HCDO Minutes
Location: UK
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1982, June - CDC (Definition)
The CDC formulates the first definition of what becomes known as AIDS. (MMWR)
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 742.
Type: AIDS Definition (CDC)
Location: USA
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1982, June - Dr E. Harris, DCMO - Awareness of Possibility of AIDS Transmission via Human Plasma
In a confidential DHSS circular of June 1982: "British Plasma-derived Vaccine against Hepatitis B" we learn that the author of the document, the Department's Deputy Chief Medical Officer, Dr Ed. Harris, was fully aware of the possibility of AIDS transmission via human plasma. It should be noted that this was in June 1982...

"Doubts have been raised now about the project, triggered by difficulties with the inactivation process necessary to render any such vaccine non-infective from free virus and by recent concern over the possibility of transmission of AIDS (Acquired Immune Deficiency Syndrome) via the human plasma from which the vaccine is derived."

We can date the source document for this information, since on page 4, under the paragraph with the heading: "Present Situation" we learn that the circular was written sometime in June 1982, and that Dr. Harris, then DCMO, was considering the importation of a US vaccine.

Note: The DHSS seemed more concerned with commercial interests - like whether to continue with the financial contribution they had been making towards the development of a plasma-derived Hepatitis B vaccine which they could exploit commercially - than the safety of products made from source-plasma obtained in questionable circumstances:

"...This is due to concern which has arisen about the possible transmission of AIDS in plasma-derived products, in circumstances where the blood donors likely to be the most productive sources of hepatitis B surface antigen happen often to be individuals at risk of developing AIDS."

It would not have been difficult for the DHSS to have foreseen, from this detailed information, that products manufactured from U.S. or other suspect source-plasma were going to be a huge threat to the lives of haemophiliacs.
Source: http://taintedblood.info/files/1242320606Hep_B_Vaccine_DCMO_June_82.pdf
Type: DHSS Circular - commercial in confidence. June 1982. Dr Ed L. Harris, Deputy Chief Medical Officer (DCMO, DH, 1977-89).
Location: UK
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1982, June - MMWR
There is evidence that AIDS may be sexually transmitted. (MMWR)
Source: Krever Commission Report (1997), Vol 3, Part IV, International Milestones: HIV and AIDS 1981-8.
Type: Evidence (MMWR)
Location: USA
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1982, 11 June - CDC Report
The CDC reports that 281 homosexual men and 33 IV drug users have been diagnosed with similar immunosuppression and opportunistic infections, with a 43% fatality rate.
Source: MDL 986 Class Action Plaintiffs Complaint (2004) LCHB, LLP. Page 17
Type: Reported figures
Location: USA
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1982, July - CDC Working Group
CDC creates a working group to study AIDS in hemophiliacs.
Source: Krever Commission Report (1997), Vol 3, Part IV, International Milestones: HIV and AIDS 1981-8.
Type: Formation of Working Group
Location: USA
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1982, July - Government officials
After public reports of the first hemophilia AIDS cases, US Government officials urge the Pharmaceuticals to implement the HBc test as a "surrogate" or "marker" to eliminate plasma contaminated by the transmitter of AIDS or Hepatitis C.
Source: MDL 986 Class Action Plaintiffs Complaint (2004) LCHB, LLP, page 19.
Type: Recommendation
Location: USA
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1982, July - CDC Meeting - Opportunistic Infections in US Hemophiliacs
The US pharmaceuticals (the Defendants) allegedly attend a meeting where the CDC publicly reports the first 3 cases of opportunistic infections among individuals with hemophilia. All 3 are reported to be heterosexual males.
Source: MDL 986 Class Action Plaintiffs Complaint (2004) LCHB, LLP, page 17.
Type: Meeting Public Report CDC Findings
Location: USA
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1982, 5 July - PHSAC
Public Health Service Advisory Committee is formed.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Committee formed
Location: UK
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1982, 6 July - USA Reports
The first US haemophiliac victim of AIDS is reported. An American report of pneumocystis pneumonia death in a haemophiliac where there was evidence of cellular immune deficiency with possible transference through blood.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Report
Location: USA
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1982, 8 July - CDC - Bruce Evatt, M.D. - 3 US Hemophiliacs with Immune Disease
Bruce Evatt, M.D. of the CDC telephones Paul Phillips, the Executive Director of the National Hemophilia Foundation (NHF), to inform him of the first 3 reported instances of "immune disease" in US hemophiliacs.
Source: Resnik, S. Blood Saga: Hemophilia, AIDS, and the Survival of a Community (1999). Page 115.
Type: CDC Notification of Immune Disease
Location: USA
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1982, 9 July - CDC Director Dr William Foege
The director of the CDC, Dr William Foege, reports the 3 US hemophiliac cases to state and territorial health officers, blood-banking organizations, FDA, the National Institutes of Health, and regional offices of the CDC.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 742.
Type: CDC Report / NIH
Location: USA
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1982, 14 July - National Hemophilia Foundation
The National Hemophilia Foundation (USA) informs hemophilia patients and treating physicians about the 3 hemophiliac cases. They say that the CDC believes that the immune deficiency might be caused by a virus transmitted through blood or blood products, as is hepatitis, but that the risk of contracting this immunosuppressive agent was minimal.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap 27, page 742.
Type: Statement
Location: USA
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1982, 16 July - CDC Findings
The CDC reports that the clinical and immunologic features of the 3 US hemophiliac patients are strikingly similar to those recently observed among homosexual males and heterosexual IV drug users. At the same time, they note that the 3 hemophilia patients do not share the risk factors of the latter two groups. The CDC stated, "Although the cause of the severe immune dysfunction is unknown, the occurrence among the three hemophiliac cases suggests the possible transmission of an agent through blood products."
Source: MMWR, July 16, 1982, Page 366
Type: Findings / Reports
Location: USA
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1982, 16 July - Committee on Opportunistic Infections, USA
At an interagency meeting, the Committee on Opportunistic Infections is established to exchange information about the cases and to conduct surveillance in patients with hemophilia.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 742.
Type: Formation of Committee
Location: USA
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1982, 16 July - DHSS Had Early Awareness of Concerns over the Safety of American Factor VIII
In a DHSS letter of 16 July 1982, we read of an early awareness of research which fairly conclusively demonstrates that:

"....plasma taken from homosexual drug-takers contains a sort of virus which goes undetected when the plasma is tested because it is suppressed by the drugs. However, when used for Factor VIII, it becomes active again."

The DHSS letter states that information has been received from the American Bureau of Biologics (via NIBSC) indicating there may be considerable publicity in the next couple of weeks concerning the safety of American Factor VIII.

From the following comment, it appears the DHSS are complacent at this stage:

"In any case with our voluntary unpaid donor system we do not have the same problems as in the States where drug addicts are tempted to give blood simply for the money. However, about half of the Factor VIII bought from commercial companies is imported from the USA."

Note: In terms of knowledge in the United Kingdom, this is one of the earlier dates (16 July 1982) which demonstrates that the DHSS had advance "private" knowledge of the safety risks from US commercial factor VIII almost 10 months earlier than we previously thought. This DHSS letter went out 1 year prior to the infamous July 1983 CSM meeting (reported in the Guardian by Sarah Hall on Friday May 25, 2007).

This early knowledge by officials also pre-dates (by 2 months) our earliest known point of awareness of AIDS by the UKHCDO (which was in September 1982). We know that Dr Craske was tasked with looking into reports of the syndrome in 3 haemophiliacs from the United States.

Source: DHSS Internal Circular Room 1208, HS1A. Dated 16 July 1982, Vol 24, page 171
http://www.taintedblood.info/tlfiles/DHSS HS1A Letter American Factor VIII 16 July 1982.pdf
Type: DOH FOI Documents
Location: UK
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1982, 27 July - Naming of Acquired Immune Deficiency Syndrome
The name AIDS (Acquired Immune Deficiency Syndrome) is chosen for the new disease by federal officials, scientists, university researchers and others at a meeting in Washington, DC.
Source: NIH Researcher Recall the Early Years of AIDS
http://aidshistory.nih.gov/timeline/index.html#1
Type: Naming of AIDS
Location: USA
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1982, 3 August - Memorandum - Cutter
At the meeting of the Public Health Service (PHS) and CDC officials in July 1982, CUTTER, BAXTER and ALPHA, fail to disclose facts that they had used cryoprecipitate containing plasma from known targeted homosexuals in the manufacture of Factor VIII and IX blood products. They fail to disclose this despite knowledge that the CDC's primary concern at the meeting is the infection of Factor VIII and IX with viruses.

Unfortunately, the Factor VIII and IX products are already in production and/or already on the shelves in US pharmacies waiting to be infused by hemophiliacs who purchase them.
(CUTTER memorandum dated August 3, 1982)

Source: MDL 986 Class Action Plaintiffs Complaint (2004) LCHB, LLP. Page 24
Type: Memorandum (Development)
Location: USA
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1982, 13 September - UK Haemophilia Centre Directors Organisation - Hepatitis B Vaccine
A licensed Hepatitis B Vaccine will be available in the UK at the end of September 1982. This vaccine is to be offered to "priority patients" with haemophilia.

A trial is to be conducted at Oxford involving Haemophilia A patients, whereby the vaccine is to be administered by subcutaneous route.

Source: Minutes of the 13th Meeting of UKHCDO, University Hall of Residence, Owens Park, Manchester. Monday 13th September 1982. Page 10, paragraph 2.
http://www.taintedblood.info/files/UKHCDO_13_September_1982.pdf
Type: HCDO Minutes
Location: UK
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1982, 13 September - UKHCDO - Autopsies - Deceased Haemophiliac Patients
At a meeting of Haemophilia Centre Directors in 1982, Dr Preston states that information regarding autopsies of all deceased haemophiliac patients will in future be collected by Haemophilia Centre Directors and returned to the UKHCDO for central analysis.

Note: The requirement of an autopsy is applied to ALL persons with haemophilia who have died. There is nothing in the minutes which indicates that the cause of death is taken into account.

Source: Minutes of the 13th Meeting of UKHCDO, University Hall of Residence, Owens Park, Manchester. Monday 13th September 1982. Page 6, paragraph 1.
http://www.taintedblood.info/files/UKHCDO_13_September_1982.pdf
Type: HCDO Minutes
Location: UK
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1982, 13 September - UKHCDO - Dr Craske - Knowledge of US Haemophiliac AIDS Cases
In a Haemophilia Centre Directors' Organisation meeting in September 1982, there is not only knowledge of AIDS infecting haemophiliacs in the USA, but also, there is some understanding of the possible involvement of commercial blood products.

Dr Craske is tasked with looking into reports of the syndrome in 3 haemophiliacs from the United States. HCDO minutes state that: "It appeared that there was a remote possibility that commercial blood products had been involved."

Source: Minutes of the 13th Meeting of U.K. HCDO, University Hall of Residence, Owens Park, Manchester. Monday 13th September 1982. Page 10, paragraph 3.
http://www.taintedblood.info/files/UKHCDO_13_September_1982.pdf
Type: HCDO Minutes
Location: UK
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1982, October - Diagnosis - First Haemophiliac Diagnosed with AIDS
First haemophiliac victim diagnosis of AIDS.
Source: Berridge, V. (1997) "AIDS and the gift relationship in the UK", in Titmuss, R M The Gift Relationship
Type: Development
Location: UK
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1982, 2 October - National Hemophilia Foundation Medical & Scientific Advisory Counsel
The National Hemophilia Foundation (USA) recommends that homosexual men, I.V. drug users, and Haitians be excluded from donating blood or plasma for manufacture in factor VIII or IX concentrates.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 743 & 746.
Type: Recommendation
Location: USA
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1982, 14 October - Factor VIII Study Group - Early Detergent Tests
Early tests are being conducted in the use of detergents to purify factor VIII. The minutes of a meeting of the SNBTS Factor VIII Study Group suggest that not only is the use of detergents possible in late 1982, but also that the process is a valid proposition: "Practically all of the detergents tested so far had proved quite successful, with a good survival rate of FVIII:C."

Note: Despite Dr. Edward Shanbrom patenting and proposing the process to US industry in 1980, solvent detergents are not widely taken up by the leading pharmaceutical companies until 1987.

Source: Minutes of Factor VIII Study Group. SNBTS Headquarters Unit. Thursday, 14th October, 1982. Page 3
http://www.taintedblood.info/files/Factor%20VIII%20Study%20Group%2014%20Oct%201982.pdf
Type: Meeting Minutes - Detergent Tests
Location: Scotland
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1982, post November - Oxford Haemophilia Centre - Cirrhosis in Children
In a document entitled: "A Prospective Study of Hepatitis in Haemophiliacs first treated with Factor VIII or IX Concentrate" it is suggested by the study that with regard to the risk of contracting transfusion hepatitis, there is no difference between NHS and US commercial factor VIII. (Page 1, end of paragraph 2)

"Since there are as yet no confirmed laboratory tests available for non-A, non-B hepatitis the only sure way of assessing the risk of transfusion hepatitis associated with new brands of concentrate where attempts have been made to inactivate hepatitis viruses by heat, ultra-violet light and propiolactone or other methods, is by use of chimpanzee inoculation experiments, or TRIALS of each product compared with an UNTREATED product in a group subjects where the susceptibility to hepatitis is known to be high. We have demonstrated such a group in the patients with mild coagulation defects already studied at Oxford. (Page 1, paragraph 4)

"Some children with cirrhosis have received concentrate for 6-7 years. (Page 2, under "Complications", 16 lines from the bottom of the page.)

Note: The worst thing we are seeing here is that it is seems to be acceptable to these physicians that CHILDREN should have cirrhosis. It should be noted that this is coming from the very people who said that they weren't aware or didn't think that hepatitis was a serious problem.

Source: A Prospective Study of Hepatitis in Haemophiliacs first treated with Factor VIII or IX Concentrate:
http://www.taintedblood.info/tlfiles/Oxford Haemophilia Centre Prospective Study 1982.pdf
Type: Recovered Document - Prospective Study - circa November 1982. Dr C.R. Rizza. Dr. J. Craske
Location: UK
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1982, 30 November - DHSS - Genetically Engineered Factor VIII Known About in 1982
In a DHSS internal circular of 30 November 1982, we learn exactly how far on scientists were in developing genetically engineered Factor VIII as early as 1982.

On reading the circular, we discover that highly purified genetically-engineered Factor VIIIc was already being produced by a team at the Royal Free Hospital and that Genentech owned the RF method. We also read that Speywood signed a collaboration agreement with Genentech in relation to genetic engineering of FVIII.

At the end of the circular, under 'STOP PRESS', we read an alarming statement by the DHSS that they thought there could be valuable spin-off from a story in The Times. The DHSS state that they thought it should prompt the CBLA into examining its proposed investment in light of current developments in genetic engineering:

The DHSS in 1982: "I feel that the sooner this exercise is done the better in order to reassure our financial colleagues and the Treasury - otherwise each new reported 'break-through' will have them rushing to cancel the cheques!"

Note: Rather disgracefully, it took another 12 years for recombinant clotting factors (made synthetically) to be licensed for use within the UK in 1994. Compare this with Hyland running human clinical trials of their recombinant Factor VIII as early as 1987, just over 4 years from the date of this DHSS circular.

From the point of being licensed, why did Government take another 12 years (right up to 2006) to make the safe product available to all adult haemophiliacs across the UK?

From 1982, that's a grand total of 24 years of delays.

Source: DHSS Internal Circular. Dated 30 November 1982
http://www.taintedblood.info/tlfiles/DHSS Genetically Engineered Factor VIII 30 Nov 1982.pdf
Type: DHSS Internal Circular from MED SEB Room 1025A, Hannibal House. Dated 30 November 1982
Location: UK
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1982, December - FDA / Baxter Agreement
The head of Baxter enters into an agreement with officials of the FDA to the effect that they would no longer use prison plasma in the production of factor concentrates.
Source: Class Action Complaint (2004) Case No. C032572 PJH. Page 24.
Additional Source: Baxter Memorandum dated 20th October, 1983.
Type: Memorandum - Baxter
Location: USA
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1982, December - CDC / Blood Products Advisory Committee
Dr Bruce Evatt of the CDC reports to the Blood Products Advisory Committee that the epidemic is growing at an almost exponential rate, doubling every 6 months.

In the same meeting, some suggestion is made that cryoprecipitate might be preferable to concentrates, but no actual recommendations are made.

Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 743 & page 769
Type: CDC Report
Location: USA
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1982, December - Report
There is a report of an occurrence of AIDS after a blood transfusion.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Report
Location: UK
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1982, 1 December - CBLA / BPL
CBLA (Central Blood Laboratory Authority) takes over BPL (Blood Products Laboratory).
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Development
Location: UK
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1982, 9 December - National Hemophilia Foundation
The National Hemophilia Foundation informs its members that 4 new cases among US hemophiliacs have been identified, and stated that "while there is insufficient data to directly link the spread of AIDS to concentrates, there is an increased concern that AIDS may be transmitted through blood products."
"...patients and parents should be aware of the potential risks."
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 769.
Type: Statement
Location: USA
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1982, 10 December - Morbidity & Morality Weekly Report
The 3 US hemophiliac AIDS patients whose cases had been reported in July have since died. There are now 4 more cases of opportunistic infections in hemophiliacs.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 740.
Type: Report (MMWR)
Location: USA
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1982, 10 December - Morbidity & Morality Weekly Report
A 20-month old infant dies in San Francisco, after receiving a blood transfusion from a donor who subsequently developed AIDS. This is the 1st published report of transfusion-associated AIDS in the USA.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 740.
Type: Published Report (MMWR)
Location: USA
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1982, 15 December - BPL - Implications of Commercial Hepatitis-Safe Factor VIII and IX
In the minutes of a meeting at BPL on 15 December 1982, we read that commercial "Hepatitis-Safe" Factor VIII and IX is about to be introduced:

"Price instability in the world market on blood products has introduced many bizarre effects, particularly in Europe. The price battle for Factor VIII intermediate concentrate in the UK is an example. Intense competition and unacceptably low prices is alleged to have resulted in the withdrawal of Hyland Hemophil II from the UK market and the threatened possibility of a second major company withdrawal in 1983."

"Manufacturers entering the trial should undertake to make positive contributions of data and financial support in return for a properly conducted trial in a well-documented community of haemophiliacs."

"It is realised that overseas producers do not have access to trial facilities of equivalent quality and veracity elsewhere." (Page 2)

Note: Again, not enough emphasis on product safety, moreover, we see only cost concerns and world market trends being placed over and above patient safety. Clearly, trials were not being conducted in the product manufacturer's country of origin, for example, the United States, because they knew all too well that such trials would not have been permitted within their law.

Source: http://www.taintedblood.info/tlfiles/Meeting at BPL Wednesday 15 December 1982.pdf
Type: Recovered Document - Meeting at BPL. Wednesday 15 December 1982
Location: UK
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1982, 24 December - Alpha - Direct Questioning Screening
Only 1 manufacturer, Alpha, implements direct questioning donor screening for AIDS. Alpha tells all its plasma collection centres to exclude intravenous drug users, homosexual men, and persons who have resided in Haiti. Donors are asked directly if they are members of the risk groups, and a statement is obtained from every male donor confirming that he has never had sex with a man. Using this method, Alpha excludes 308 donors in just three weeks (from the last week of December 1982 to mid-January 1983).
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 746.
Type: Implementation of Direct Questioning Screening
Location: USA
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1982/3 - NANBH - More Serious than Previously Thought
Studies published that indicate that NANBH (Non-A Non-B Hepatitis) is more serious than previously thought.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Studies. Taken from DOH Self-sufficiency Report
Location: UK
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1983 - BMJ - Non-A Non-B Hepatitis Contraction
British Medical Journal publishes evidence that "a very high percentage of Haemophiliacs contract Non-A Non-B hepatitis after 1st use of concentrates".
Source: Fletcher ML, Trowell JM, Craske J et al. Non-A non-B hepatitis after transfusion of factor VIII in infrequently treated patients. BMJ 1983;287:1754-7.
Type: Article, BMJ
Location: UK
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1983 - US Hemophilia Patients Contract AIDS - Concern Over Commercial Products
US patients with haemophilia who contracted AIDS strengthens concerns over the safety of imported commercial blood products.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Concerns
Location: UK
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1983, 4 January - PHS / CDC / FDA / NIH Public meeting in Atlanta
More than 200 representatives attend a public meeting in Atlanta with the United States Public Health Service (PHS). Hepatitis B Core Antibody (HBc) testing is strongly suggested to the Pharmaceuticals by the CDC. However, representatives of the blood banks and plasma industry object because it would be too expensive.
Dr Donald Francis recommends "direct questioning" of blood donors to reduce transmission, however, representatives of the gay community object to this proposal as it would be discriminatory.
Source: First Amended Class Action Complaint (2004) Case No. C032572 PJH. Page 19.
Additional Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 744.
Type: CDC Public Meeting & Recommendation / National Institutes of Health
Location: USA
Top
1983, 4 January - CDC / PHS Meeting - Donor Screening in USA
Following a CDC meeting, evidence leads the Public Health Service (PHS) to conclude that donors at risk of AIDS transmission should be screened to eliminate them from the US blood supply.
Source: First Amended CLASS ACTION COMPLAINT (2004) Case No. C032572 PJH. Page 29.
Type: Meeting, CDC
Location: USA
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1983, January - James Curran, Head of CDC Task Force
The head of the CDC Task Force, James Curran, states: "The sense of urgency is greatest for haemophiliacs. The risk for others [who receive blood products] now appears small, but is unknown."
Source: Marx J. L. (1983) Health officials seek ways to halt AIDS, Science, 21 January 1983.
Additional Source: Avert.org The History of AIDS, 1981-1986.
Type: Statement / Concerns
Location: USA
Top
1983, 6 January - PMA / Armour, Baxter, Cutter, Alpha - FDA - Warning Labels
At a meeting of the US Pharmaceutical Manufacturer's Association, the blood companies agree not to implement the highly effective Hepatitis B Core Antibody (HBc) donor screening, and instead opt to use ineffective donor questionnaires.

At the same meeting, all four US plasma companies agree to postpone submitting any request to the FDA for permission to amend their warning labels or package inserts and they agree not to apply to the FDA until the other 3 companies have agreed to make their applications and to make the warnings similar in content.

Source: First Amended Class Action Complaint (2004) Case No. C032572 PJH. Pages 19 & 40.
Type: Decision - Warning labels
Location: USA
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1983, 6 January - Meeting Red Cross, AABB, CCBC
At a meeting of the members of the voluntary blood sector - the American Association of Blood Banks, the Red Cross, and the Council of Community Blood Centres an agreement is reached on a number of measures to reduce the risk of transmitting AIDS.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 747.
Type: Meeting / Agreement
Location: USA
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1983, 10 January - Dr Craske Prematurely Considers Factor VIII AIDS Problem Satisfactorily Resolved
In a PHLS letter of January 1983, rather remarkably, we read that the author, Dr J. Craske, considered the problem related to the investigation of factor VIII-related Acquired Immune Deficiency Syndrome (AIDS) "satisfactorily resolved".

His inadequate solution reads as follows: "The problem related to the investigation of factor VIII related Acquired Immune Deficiency Syndrome (AIDS) has been satisfactorily resolved. We will report any patient detected in the U.K. who has received U.K. commercial factor VIII direct to the C.D.C. and will at the same time notify C.D.S.C. at Colindale."

Background: On 13 September 1982, Dr Craske was tasked with looking into reports of the syndrome in 3 haemophiliacs from the United States. The HCDO minutes stated that: "It appeared that there was a remote possibility that commercial blood products had been involved." We hardly think that putting in place a simple detection and reporting protocol could be considered a satisfactory resolution to the problems surrounding AIDS and commercial factor VIII. We are appalled that more wasn't done.

Note: The reference on the letter from the PHLS of 10th January 1982, shows the letters "JC", which we believe are the initials for Dr John Craske.

Source: PHLS Letter to DHSS. 10th January 1983
http://www.taintedblood.info/tlfiles/PHLS Letter of 10 January 1983.pdf
Additional Source:
http://www.taintedblood.info/files/UKHCDO_13_September_1982.pdf
Type: Letter from Dr J Craske of the Public Health Laboratory, Manchester to Department of Health and Social Security. Dated 10th January, 1983
Location: UK
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1983, 13 January - Lederman, Menitove & Desforges (NEJM)
A number of articles in the New England Journal of Medicine on Hemophiliacs and AIDS:

  • Lederman reports widespread immunity abnormalities, possibly linked to AIDS.
  • Menitove states that AIDS has a 40 per cent mortality, and reports widespread cell abnormalities.
  • Desforges recommends Cryoprecipitate rather than concentrate because of the risk of AIDS.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Articles: New England Journal of Medicine
Location: USA
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1983, 13 January - Red Cross, AABB, CCBC
The voluntary sector announces in a statement that medical histories of prospective donors will include specific questions designed to detect symptoms of, or exposure to, AIDS. Prospective donors will be asked whether they have had a history of night sweats, unexplained fevers, unexpected weight loss, or were suffering from lymphadenopathy or Kaposi's sarcoma.

The American Association of Blood Banks, the Red Cross, and the Council of Community Blood Centres states that the use of surrogate tests is currently being evaluated in areas of the US where AIDS is most prevalent.

Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 747 & 761.
Type: Statement
Location: USA
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1983, 14 January - National Hemophilia Foundation (NHF)
The heads of the 4 US pharmaceuticals and the National Hemophilia Foundation (NHF) attend a meeting where the 4 blood companies are concerned that the NHF will insist on a recommendation that Hepatitis B Core Antibody testing be implemented, consistent with the CDC recommendation 10 days earlier.

3 manufacturers: Armour, Cutter, and Hyland - state that they will introduce "active methods" of donor screening within the next two weeks.

BAXTER had already conducted a survey of several donor centers and determined that up to 16% of their donors would not pass the new test, additionally BAXTE'S high titered immunoglobulin donors would be eliminated.

In order to defer the NHF recommendation, Rodell tells officials that testing is currently in the "Research and Development, stage", however, the HBc Antibody test was not in the R and D stage and it had been approved by the FDA in 1979 and was suitable for use as a screening device.
(CUTTER Memorandum dated January 17, 1983.)

Source: Class Action Complaint (2004) Case No. C032572 PJH. Page 26.
Additional Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, Page 747
Type: Meeting
Location: USA
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1983, 15 January - Dr Jones - Link Between AIDS and Common Cell Immunity in Haemophiliacs
A Lancet report by Dr Jones describes the link between AIDS and common cell immunity in haemophiliacs.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Lancet Report
Location: UK
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1983, 20 January - Cutter
CUTTER is engaged in a conspiracy with other US Pharmaceuticals to conceal their use of high-risk donors in factor concentrates that are currently on the market. CUTTER has formed an alliance with the other 3 blood companies in order to avoid timely warnings or effective donor screening and immediate recalls of high-risk blood products.
(ALPHA Memorandum dated January 20, 1983.)
Source: Class Action Complaint (2004) Case No. C032572 PJH Page 26
Type: Memorandum (Alpha)
Location: USA
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1983, 28 January - American Blood Resources Association
The American Blood Resources Association, (a group representing blood product manufacturers), issues a statement recommending that member firms distribute pamphlets designed to discourage high-risk donors, that donors be questioned about symptoms of AIDS, and be required to sign a declaration acknowledging that they are not at high risk of contracting AIDS.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 747.
Type: Statement
Location: USA
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1983, February - Blood Centres / Commercial Plasma Centers
Both voluntary US blood centres and commercial US plasma centres are now asking donors whether they have symptoms of AIDS and are making efforts to avoid recruitment in areas where the population is at high risk of contracting AIDS.
Plasma centres are recommending the use of pamphlets and donor declarations. One plasma centre has implemented direct questioning; and one blood bank has introduced confidential unit exclusion.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 748.
Type: Developments
Location: USA
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1983, 14 February - Confusion Over Whether Crown Immunity Applied in Scotland
In a letter dated 14th February 1983, from B. K. Chambers (DHSS) to Mr Murray (SHHD), there appears to be some considerable confusion as to whether Crown Immunity applied to Scotland.
"The issue of manufacturing licences for the Blood Transfusion Centres in Scotland when similar licences were not issued in England and Wales resulted, as you know, from differing legal advice in each case. Scottish law officers held that Crown Privilege did not apply and that licences were required; legal advice for England and Wales held that Crown Privilege did apply and that licences were not necessary. Licences were therefore issued for BTS Centres in Scotland but not for BTS Centres in England and Wales.
We were advised in 1979 (Mr Sutherland wrote to Mr Firstbrook) that the Scottish law officers had reviewed their original opinion and decided that Crown Privilege did apply to the CSA and Health Boards in Scotland, and that formal licensing of the Blood Transfusion Service in Scotland was no longer required. In other words from that time the BTS in Scotland was on the same footing vis-a-vis the Medicines Act as the BTS in England and Wales."

Note: The differences of opinion do seem to eventually settle on the view that Crown Immunity did apply to Scotland.

Source: http://www.penroseinquiry.org.uk/finalreport/pdf/SNB0087481.PDF
Type: Penrose Evidence File
Location: Scotland
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1983, March - HCDO - Request to Report Any Case of AIDS in Haemophiliac Patients
The Directors of haemophilia treatment centres are requested to report any cases of AIDS in haemophilia patients to their national centre in Oxford. This data is then to be relayed to the Communicable Disease Surveillance Centre.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 33, page 928.
Type: Report
Location: UK
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1983, March - Alpha / ABRA Forum (Dr Nemo)
The Alpha/ABRA Forum includes a false statement attributed to Dr. Nemo: "It is not at all clear, (Dr. Nemo said), that an infectious AIDS agent, if one exists, can be spread by blood products. The link between AIDS and its possible transmission by blood products is very tenuous indeed."

Note: At this time, there is overwhelming scientific evidence supporting the conclusion that AIDS is transmitted by blood products such as factor concentrates.

Source: Highlights from the 1983 ABRA Plasma Forum, A Professional Service of Alpha Therapeutic Corporation,
March 1983
Type: Forum statement
Location: USA
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1983, March - FDA Introduces New Regulations for the Collection of Plasma
FDA introduces new regulations for the collection of plasma excluding donors from high-risk groups.

The use of pre-March 83 stocks are not banned owing to concerns that this would lead to a crisis in supply.

Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Regulations. Taken from DOH Self-sufficiency Report
Location: USA
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1983, 4 March - PHS / Department of Health and Human Services
Public Health Service interim recommendations are announced by the Department of Health and Human Services stating that members of groups at high risk of contracting AIDS be urged to refrain from donating blood. However, these recommendations are not binding on US blood banks.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 744 & 748.
Type: PHS Interim Recommendations
Location: USA
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1983, 7 March - American Red Cross, AABB, CCBC
In a joint-statement by the American Red Cross, the American Association of Blood Banks, and the Council of Community Blood Centres, the principles of the PHS recommendations (of 3 days earlier) are endorsed. Members of groups at high risk of contracting AIDS are to be urged to refrain from donating blood.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 744.
Type: Joint Statement
Location: USA
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1983, 9 March - CSM Sub-Committee on Biological Products / Alpha
The CSM Sub-Committee on Biological Products declines a product licence to Alpha Therapeutic Limited for bulk cryoprecipitate (PL 4447/0004 ANTIHAEMOPHILIC FACTOR HUMAN WET-PASTE BULK CRYOPRECIPITATE). The Sub-Committee are unable to recommend the granting of a product licence for the following reasons:
  • failure to provide adequate details on the manufacturing process
  • failure to provide adequate evidence of the product's efficacy
  • failure to provide evidence that the cryoprecipitate was at least equivalent in quality to that used for the manufacture of Alpha's factor VIII
  • there should be an undertaking offered that a donor list will be available to the manufacturer.
Source: Minutes of the Committee on the Safety of Medicines - Sub-Committee on Biological Products. Appendix C. 9 March 1983.
http://www.taintedblood.info/files/CSM_9_March_1983.pdf
Type: Product Licence Refusal
Location: UK
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1983, 15 March - Cutter
Dr. Bruce Evatt of the CDC informs Cutter that based upon the observed T-cell abnormalities in hemophiliacs, he expects 50% of them to develop full blown AIDS.

The 4 US fractionators (blood companies) are engaged in meetings with the FDA with a common goal of averting a complete recall, the only responsible option available to them.

Source: Class Action Complaint (2004) Case No. C032572 PJH Page 28
Type: Meeting
Location: USA
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1983, 22 March - PHLS - Trials of "Hepatitis Reduced" Factor VIII
In a draft letter outlining the protocol of a trial of "hepatitis reduced" factor VIII, under the heading Procedure it states: "Patients attending any of the collaborating Haemophilia Centres during the course of the project who fulfil the criteria given will be admitted to the study."

"The object of the study will be explained to them, and their consent or that of their parents obtained, if under 16 years of age."

Source: Craske J, Rizza C, Bloom A. Public Health Laboratory Service (PHLS) letter to Haemophilia Centre Directors. 22 March 1983
http://www.taintedblood.info/tlfiles/PHLS Letter 22 March 1983.pdf
Type: Draft PHLS Letter - Trial Protocol
Location: UK
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1983, 22 March - PHLS, J. Craske - Post-AIDS Trials Plans - Involving Previously Untreated Patients
In a draft PHLS letter from J. Craske, Charles Rizza and Arthur Bloom, it is clear that possibly unethical trials of 'Hepatitis Reduced' Factor VIII are still being planned as late as 22nd March 1983:

"You will see that the class of patients to be given these products are those who have had no previous treatment with factor VIII concentrate."

"It is likely that there are only a limited number of these patients in the U.K. who will require factor VIII therapy in any one year. We will be grateful if you notify Dr. J. Craske of any approaches from commercial firms with a proposal to evaluate their product."

Note: This is really damning evidence. It is monstrous that the PHLS are still actively looking for both Previously Untreated Patients (PUPs) and inviting approaches from commercial firms as late as March 1983 in order to expose previously untreated patients to hepatitis for the sake of their trials, especially whilst Dr Craske categorically had knowledge of AIDS from 13th September 1982; at which point, he was tasked with looking into reports of the syndrome in 3 haemophiliacs from the United States where there was the 'remote' possibility that commercial blood products had been involved.

Source: http://www.taintedblood.info/tlfiles/PHLS Letter 22 March 1983.pdf
Additional source:
http://www.taintedblood.info/files/UKHCDO_13_September_1982.pdf
(see page 10, final paragraph)
Type: Recovered Document - Craske J, Rizza C, Bloom A. Public Health Laboratory Service (PHLS) letter to Haemophilia Centre Directors. 22 March 1983
Location: UK
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1983, 23 March - US Food and Drug Administration - Post-March 23rd Regulations
FDA requirements on blood donations introduced.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Regulations
Location: USA
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1983, 24 March - PHS Recommendations
Public Health Service (PHS) replace the interim recommendations with stricter mandatory screening guidelines for US blood and plasma donors in order to reduce the risk of AIDS transmission, because of the evidence supporting transmission of AIDS in factor concentrate. Blood Banks are told to introduce educational programs to inform groups at risk.
Source: Class Action Complaint (2004) Case No. C032572 PJH Page 29.
Additional Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 749.
Type: Recommendations
Location: USA
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1983, 25 March - Krever Report
There are now more than 1,100 cases of AIDS reported in the United States since June 1981, with more than 400 deaths.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 749.
Type: Statistics
Location: USA
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1983, 28 March - NIBSC - AIDS Problem in Relation to Licensed Blood Products
In a letter from the National Institute of Biological Standards and Control (NIBSC) in March 1983, we learn that they thought it would be advisable to consider the problem of AIDS in relation to licensed blood products at a meeting of the CSM(B) (Committee on the Safety of Medicines Biologicals Sub-committee).

The following is stated: "Attached are letters recently released by FDA, on or about the 17th March 1983. You will see that the US are taking steps to avoid the use of blood from high risk groups in the preparation of certain blood products."

Source: http://www.taintedblood.info/tlfiles/NIBSC AIDS and Licensed Blood Products 28 March 1983.pdf
Type: Letter from NIBSC, National Institute for Biological Standards and Control. Dated 28 March 1983.
Location: UK
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1983, 29 March - SNBTS - Collection of Blood from Prisons and Borstal Institutions
In a meeting in 1983, SNBTS Directors warn that the Medicines Inspector has commented adversely on the practice of collecting blood from prisons and borstal institutions.

It is reported by all Directors present that sessions were held in penal institutions in all regions.

Source: Scottish National Blood Transfusion Service, Minutes of Directors' Meeting, SNBTS Headquarters Unit. 29 March 1983
http://www.taintedblood.info/files/MINS_OF_DIRECTORS_MEETING_HQ_29_MAR_1983.pdf
Type: SNBTS Minutes March 29, 1983
Location: Scotland
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1983, Spring - Hyland / FDA
Hyland - Travenol is the first US plasma manufacturer to receive regulatory approval from the FDA to distribute dry heat-treated Factor VIII products.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap 27, page 755 and Krever Commission Report (1997), Vol 3, Part IV, International Milestones: HIV and AIDS 1981-8.
Type: Regulatory Approval
Location: USA
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1983, 30 April - Investigation of Haemophiliacs in an Area Where AIDS Had Not Yet Been Introduced
By 3rd of March, 1983, there were eleven cases of acquired immunodeficiency syndrome (AIDS) in haemophiliacs who had all received factor VIII concentrate. These cases had been reported to the CDC in the USA.

By 30th April, 1983, a letter, entitled: 'Factor VIII Products and Disordered Immune Regulation' was published in the UK in The Lancet by Dr Robert S. Gordon, Jr. of the National Institutes of Health (NIH), Bethesda, USA. The letter stated:

"These observations are consistent with the hypothesis that AIDS is caused by a transmissible agent, presumably a virus, that can be included in blood products, and that some recipients of the agent have not (at least not yet) developed the complete clinical syndrome with its devastating complications."

"These alternative hypotheses might be distinguished through a study of T-lymphocyte subpopulations among similarly treated haemophiliacs in a geographical area to which AIDS has not yet been introduced. The resolution of this question by a timely investigation in some country, where cases of AIDS have not yet been reported would be an immense help to public health workers worldwide. In this situation "negative results" would be of great significance."

NOTE: Please click the 'Find Related Entries' link below to see how this Timeline entry relates to the one for 10th October 1983 regarding the Medical Research Council. It appears that Dr Gordon's letter somehow managed to engender a controlled AIDS study of UK Haemophiliacs; the Edinburgh Haemophiliac Cohort; a study which we believe to have been entirely unethical. TaintedBlood has members who have testified at the Archer Inquiry where they expressed belief that their infections where acquired as a result of this study. (see 2nd link below)

Source: http://www.slowlyslowlycatchymonkey.com/Dr Gordon Letter in Lancet April 83.pdf
Evidence of Robert and Alice Mackie:
http://slowlyslowlycatchymonkey.com/18.html
Type: Letter, The Lancet, 30th April, 1983
Location: Scotland
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1983, May - Construction starts at BPL
Construction started at BPL.

Note: This work should have been completed by approximately 1978, so it stands to reason that this construction at BPL is rather later.

From as early as 1973, Government knew that production of Factor VIII in the UK was insufficient. The aim to become self-sufficient in blood products was already in place, and by 1976 they had re-affirmed their aim to become self-sufficient by mid-1977. There had also been the World Health Organisation (WHO) resolution stating that each country should be able to supply sufficient quantities of its own blood and blood products to meet clinical needs.

Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Development
Location: UK
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1983, May - ECHO Article - Dr Louis Aledort, Medical Co-director of Sinai Hospital, NY
CUTTER publishes an article understating the risk of AIDS by presenting the view of Dr. Louis Aledort who stated: "Put AIDS Disease in Perspective," as follows: "AIDS should not be viewed as a "panic signal" or a reason to change a hemophilia patient's therapy." CUTTER chose to print this statement in enlarged text.

Note: There was substantial evidence to justify a change in therapy and a complete recall of unscreened Factor VIII by May 1983.

Source: Class Action Complaint (2004) Case No. C032572 PJH Page 29
Type: Article (ECHO)
Location: USA
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1983, May - 1st US Product Withdrawal
The first factor VIII product withdrawal in the US occurs in May 1983. The National Hemophilia Foundation does not re-evaluate the use of factor concentrates.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 770.
Type: Development (Product Withdrawal)
Location: USA
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1983, 3 May - Dr Vaughan, ex Health Minister, Was Warned in 1981 of Danger of Contaminated Blood
In an Oral Question in Prime Minister's Question Time on Tuesday 3rd May 1983, Mr Race makes it clear that Dr Gerard Vaughan, former Minister for Health, was warned 2 years earlier, circa May 1981, of the danger of contaminated blood supplies from the USA:

Mr. Race: "As the House of Commons' favourite own-goal merchant, the Minister for Consumer Affairs, was warned two years ago by his own Department of the danger of contaminated blood supplies coming from the United States, will the Prime Minister rectify that deplorable and disgraceful mistake by immediately authorizing the necessary expenditure within the National Health Service to make Britain independent in its blood supplies?" (see first column, para 9.)

Note: This Oral Question reveals that Dr Gerard Vaughan, then Minister for Health, knew sometime in 1981, possibly from as early as May, of the threat of contaminated blood supplies which were being imported from the United States. This is one of the earliest warnings that we are aware of so far and we are astonished to learn of how early this awareness was, and that so little was done. Clearly, we are not being told everything.

Source: http://www.taintedblood.info/tlfiles/Oral Answer Mr Race and PM 3 May 1983.pdf
Additional source (see para 5)
http://www.taintedblood.info/tlfiles/Health and Social Service Journal May 12 1983.pdf
Type: Oral Answer, Prime Minister's Question Time. 3rd May 1983. Additional Source: Health and Social Services Journal, May 12, 1983. Article by Michael White. (see paragraph 5)
Location: UK
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1983, 4 May - Professor Bloom - Attempt to Reassure the Haemophiliac Community
In a letter to the Haemophilia Society in May 1983, Professor Arthur Bloom attempts to 'reassure' members of the Society about the 'true position' in the wake of 'unduly alarmist' press coverage of the AIDS crisis.

We would like to comment in turn on the following statements made by Professor Bloom:

Bloom: "Haemophiliacs, their parents and doctors have always balanced the quality of life and the dangers from bleeding against the risks of treatment."

Note: TRUE regarding the balancing act. But we would have to state that we were not always informed of the risks, in fact, hardly ever, if at all. We know that trials of 'Hepatitis Reduced' Factor VIII were still being planned as late as 22nd March 1983 (after the UKHCDO suspected the link between AIDS and Factor VIII) and that the PHLS were still actively looking for Previously Untreated Patients (PUPs) and courting approaches from commercial firms in order to expose previously untreated patients to hepatitis for the sake of trials.

Bloom: "The cause of AIDS is quite unknown and it has not been proven to result from transmission of a specific infective agent in blood products."

Note: We must take exception with this based upon documented evidence regarding exactly what Professor Bloom knew or strongly suspected at that time. Professor Bloom was Chairman of the UKHCDO at the 13th September 1982 meeting; which was 8 months earlier. It is minuted on page 10, paragraph 3, that Dr Craske was tasked with looking into reports of the syndrome in 3 haemophiliacs from the USA and that it appeared that there was a remote possibility that commercial blood products had been involved.

Bloom: "In addition the importation of licensed blood products has always been strictly monitored and controlled."

Note: We find this shocking statement to be both inaccurate and misleading. We know from the 11 January 1982 Oxford Letter that Professor Bloom had an excellent understanding of the 'named patient' basis and had discussed plans to request exemption from a Clinical Trials Certificate in respect of individual products in order to expedite trials.

Source: http://www.taintedblood.info/tlfiles/Professor A Bloom 4 May 1983.pdf
Additional source:
http://www.taintedblood.info/files/UKHCDO_13_September_1982.pdf
Type: Letter from Professor Arthur Bloom to the UK Haemophilia Society. Dated 4th May, 1983.
Location: UK
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1983, 6 May - DHSS / CDSC - Cardiff Haemophiliac with Symptoms of AIDS
On 6th May 1983, the CDSC telephones the DHSS to inform them that a 23 year old haemophiliac patient in Cardiff is now showing the appropriate symptoms for an AIDS diagnosis.

This man had been infused with American Factor VIII.

Source: http://www.taintedblood.info/tlfiles/DHSS Letter Cardiff Haemophiliac 6 May 1983.pdf
Type: Recovered Document - DHSS Letter. American Factor VIII. Cardiff Haemophiliac. Dated 6th May 1983
Location: UK
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1983, 9 May - PHLS / DHSS - Decision to Withdraw USA Blood Products
In a letter from Dr N. Galbraith of the Public Health Laboratory Service (PHLS) to Dr Ian Field of the DHSS in May 1983, the following is stated:

"... I have reviewed the literature and come to the conclusion that all blood products made from blood donated in the USA after 1978 should be withdrawn from use until the risk of AIDS transmission by these products has been clarified. Appended is a paper in which I set out my reasons for making this proposal. Perhaps the subject could be discussed at an early meeting with haematologists, virologists and others concerned so that a decision may be made as soon as possible."

"In conclusion, I say that I am most surprised that the USA manufacturers of the implicated blood products have not informed their customers of this new hazard. I assume no critical warning has been received in the United Kingdom?"

Note: Why did the DHSS not agree with PHLS (CDSC)? After all, the PHLS were the people who should have had the last word.

Source: http://www.taintedblood.info/tlfiles/Galbraith Letter May 1983.pdf
Type: Recovered Document - Letter from Dr N S Galbraith of the PHLS to Dr Ian Field, DHSS. Dated 9th May 1983.
Location: UK
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1983, 10 May - DHSS - Licensing of Imported Blood Products and Batch Release Conditions
In a DHSS circular of 10th May 1983, the licensing situation in relation to the import of blood products is discussed. The following passages are quoted verbatim from the circular:

IMPORT OF BLOOD PRODUCTS

"Imports of blood products into the United Kingdom for medicinal purposes have to be licensed under the Medicines Act 1958. Licensed products must satisfy the requirements of the Act for safety quality and efficacy."

"It is made a condition of product licences in this field that the licence holder exercises proper quality control, which involves accounting for the source and quality of the blood, its processing and final product examination. On all blood products the licensing authority imposes a "batch release" condition under which samples must be supplied for testing by the National Institute for Biological Standards and Control [NIBSC]."

"Although all medicinal products require a product licence if they are to be promoted for medicinal use, a doctor may prescribe an unlicensed product provided this is on what is known as a "named patient" basis."

Source: DHSS Circular on Import of Blood Products. Dated 10th May, 1983,
http://www.taintedblood.info/tlfiles/Import of Blood Products and Licensing 10 May 1983.pdf
Type: DHSS Circular from HS1A Med SEB on
Location: UK
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1983, 13 May - DHSS - Inaction over AIDS - Decision not to Withdraw US Factor VIII
In a DHSS letter of 13th May 1983, it is clear that the DHSS has had sight of a letter from the CDSC (dated 9th May 1983), in which a recommendation that American FVIII concentrates should be withdrawn from use because of the risk of transmitting AIDS.

Nevertheless, the DHSS appear to take little notice:

"In my view this suggestion is premature in relation to the evidence and unbalanced in that it does not take into account the risks to haemophiliacs of withdrawing a major source of their FVIII supplies".

Note: Where were the DHSS obtaining their medical advice? The HCDO had already had 9 months to consider the problem of imported Factor VIII as Dr Craske had been specifically tasked by the HCDO with looking into reports of AIDS in 3 haemophiliacs from the United States - this was in September 1982. Dr Craske, at that time, had suspected a link to commercial Factor VIII and this was minuted.

Source: http://www.taintedblood.info/tlfiles/DHSS Action on Aids 13 May 1983.pdf
Additional Source: Minutes of the 13th Meeting of U.K. HCDO
http://www.taintedblood.info/files/UKHCDO_13_September_1982.pdf
Type: Recovered Document - DHSS Letter. Med SEB. 'Action on Aids'. Dated 13th May 1983.
Location: UK
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1983, 13 May - HCDO Special Meeting - Inaction Over the Threat of AIDS to Haemophiliacs
In a specially convened meeting of the Haemophilia Reference Centre Directors on 13th May 1983, the Physicians present, (including Dr Diana Walford observer for the DHSS), fail to take any action over the threat of AIDS to haemophiliacs:

"It was agreed that there was insufficient information available from the U.S. experience to warrant changing the type of concentrate used in any particular patient. Moreover once the condition is fully developed it seems to be irreversible so that there would seem to be no clinical benefit to be gained by changing to another type of factor VIII." (page 2, paragraph 2)

"With regard to general policy to be followed in the use of factor VIII concentrates, it was noted that many directors have up until now reserved a supply of National Health Service concentrates for children and mildly affected haemophiliacs and it was considered that it would be circumspect to continue with that policy. It was also agreed that there was, as yet, insufficient evidence to warrant restriction of the use of imported concentrate in other patients in view of the immense benefits of therapy." (page 2, paragraph 3)

Prior to this meeting, physicians should reasonably have known the following:

  • As early as 13th September 1982, Dr J. Craske was tasked with looking into reports of the syndrome in 3 haemophiliacs from the United States, and he suspected a remote possibility that commercial blood products were involved.
  • On 15th January 1983, there had been an article in the Lancet by Dr Jones (a member of the UKHCDO) where AIDS had been linked to common cell immunity in haemophiliacs.
  • By March 1983, the Directors of Haemophilia Centres were requested to report any cases of AIDS in haemophilia patients to the Oxford centre, to then be relayed to the Communicable Disease Surveillance Centre.
  • On 23rd March 1983, in the USA, FDA regulations for the collection of plasma excluding donors from high-risk groups were introduced. However, use of pre-March 1983 stock was unfortunately NOT banned due to supply concerns.
  • On 6th May 1983, the UK's CDSC telephoned the DHSS to inform them that a 23 year old haemophiliac patient from Cardiff was now showing symptoms of an AIDS diagnosis after having been infused with US Factor VIII.
  • On 9th May 1983, the CDSC had written a crucial letter recommending that American FVIII should be withdrawn from use due to the risk of transmitting AIDS.
Source: http://www.taintedblood.info/tlfiles/HCDO Special AIDS Meeting 13 May 1983.pdf
Type: HCDO Haemophilia Reference Centre Directors Organisation - Minutes. Dated 13th May 1983.
Location: UK
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1983, 13 May - Haemophilia Reference Centre Directors - Decision Not to Restrict Imported Factor VIII
At a Meeting of the Haemophilia Reference Centre Directors on 13th May 1983, the Directors decided that, on the evidence available, (and because of the benefits of treatment), that no restriction should be placed on imported Factor VIII concentrate.

The only exception the Directors made was to continue with their policy of only using NHS material for children under the age of 4 and for mild haemophiliacs.

Background: Why didn't the Directors of Haemophilia Centres try and do more to ban imported Factor VIII concentrate? They appear to have ignored the following warnings:

  • Dr Craske had been tasked by the HCDO with looking into reports of the syndrome in 3 haemophiliacs from the United States a whole 9 months before (in September 1982) and he suspected a link to commercial Factor VIII.
  • 5 months earlier, (January 1983) there had been an article in the Lancet by Dr Jones (also HCDO), where AIDS was linked to common cell immunity in haemophiliacs.
  • The FDA requirements on blood donations had already been introduced on 23rd March 1983 - this was 2 months before this decision.
  • On 6th May, (1 week earlier) the CDSC telephoned the DHSS to inform them that a 23 year old haemophiliac patient in Cardiff was now showing symptoms of an AIDS diagnosis after having been infused with US Factor VIII.
  • On 9th May 1983, (4 days earlier), the CDSC had written a letter recommending that American FVIII should be withdrawn from use due to the risk of transmitting AIDS. The DHSS definitely had sight of this CDSC letter by 13th May 1983.
Source: http://www.taintedblood.info/tlfiles/AIDS Background Paper II 31 May 1983.pdf
Additional Source: Minutes of the 13th Meeting of U.K. HCDO
http://www.taintedblood.info/files/UKHCDO_13_September_1982.pdf
Type: Recovered Document - AIDS Background Paper II. Dated 31st May 1983.
Location: UK
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1983, 16 May - DHSS - AIDS and Imported Factor VIII - Fear of Dumping

In a DHSS Circular of 16 May 1983, we read about the fears of UK haemophilia centre directors that contaminated US Factor VIII might be 'dumped' in the United Kingdom following the 24th March 1983 FDA requirements in respect of the selection of donors with the overall aim of reducing the possibility of transmission of AIDS.

"Products manufactured from plasma taken before the new regulations were introduced have to be labelled to indicate this." "However, the UK product licenses do not contain this requirement and there are fears among haemophilia centre directors that the more "dangerous" material may be dumped in the UK."

This DHSS circular goes some way toward posing questions that, if acted upon, could have helped the situation:

  • Is it possible to obtain concentrates made from American plasma which does not come from donor centres in New York (particularly) but also from San Francisco and Los Angeles....?
  • Is it possible to accept only concentrates made from plasma taken after the 24th March regulations?
  • Can we find out, for each manufacturer, the date of plasma collection in relation to each batch of concentrate in current use in the UK?
  • Could Immuno - or other European manufacturers - produce sufficient material derived from European plasma to supply up to 30 million i.u. of FVIII concentrate should it prove necessary to withdraw some or all of the American products?

Note: Clearly this goes somewhere toward showing willing and raising questions over what action to take. So what went wrong and why were these suggestions not followed up?

Source: DHSS Circular. Dated 16 May 1983.
http://www.taintedblood.info/tlfiles/DHSS Factor VIII and AIDS Fear of Dumping 16 May 1983.pdf
Type: DHSS Circular. Dated 16 May 1983 entitled
Location: UK
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1983, 16-20 May - Council of Europe - Draft Recommendations on Coagulation Factors and AIDS
At a Council of Europe meeting in Lisbon (16-20th May 1983), a draft resolution is accepted recommending that the use of coagulation factors prepared from large plasma pools should be avoided except where such a product was specifically indicated for medical reasons.

The terms of the recommendations are as follows:
  • To take all necessary steps and measures in respect of AIDS.
  • To avoid the use of coagulation factor products from large plasma pools, except when such a product is specifically indicated for medical reasons; this is especially important for those countries where self-sufficiency in the production of such products has not been achieved.
  • To inform attending physicians and selected recipients, such as haemophiliacs, of the potential health hazards of haemotherapy and the possibility of minimising these risks.
  • To provide all donors with information on AIDS, so that those in high risk groups will refrain from donating.
  • To pursue rapid and full implementation of recommendations of R(80)5 and R(81)14.
Source: http://www.taintedblood.info/tlfiles/Council of Europe CBLA Notes 16-20th May 1983.pdf
Additional Source: Council of Europe Recommendation No. R (83) 8 for 23rd June 1983:
http://www.coe.int/t/e/social_cohesion/health/recommendations/Rec(83)8.pdf
Type: Recovered Document - Draft Recommendations of the Council of Europe
Location: Lisbon / Europe
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1983, 16th-19th May - Dr Gunson - Informal Report on 6th Meeting of The Council of Europe
In an informal report on the Council of Europe Committee of Experts on Blood Transfusion and Immunohaematology, Dr H. Gunson presents the following extracts in relation to Acquired Immune Deficiency Syndrome (AIDS):
  • The significance of AIDS to the Committee was in relation to the effects with respect to the transfusion of blood and blood products, particularly with coagulation factor concentrates given to patients suffering from haemophilia. Absolute proof that AIDS is cause by a transmissible infectious agent is not yet available, but the consensus in the Committee was that it should be regarded as such that a recommendation should be made to the Council of Ministers at the meeting in June to take necessary steps to minimize the transmission of AIDS by the transfusion of blood products. (page 1, paragraph 4)
  • With respect to the importation of plasma products, particularly from the USA, I find it difficult to believe that these can be phased out in the near future, since the Haemophilia Directors have always maintained that they require up to 100 per cent more Factor VIII for the treatment of haemophilia than can be produced from BPL. No doubt the opinion of the CBLA will be sought on these aspects. (page 2, point 4)
  • It is important, I think to avoid "emotive over-reaction" amongst recipients, a phrase which will also appear in the recommendations. (page 2, final paragraph.)
  • As will be evident from the above, the implications of AIDS in various aspects of blood transfusion practice kept appearing. Undoubtedly it is an important disease with a high mortality rate which has attracted considerable press publicity. Whilst it has not yet reached proportions in Europe as it has in the USA many members of the Committee considered that we may be seeing the beginnings of a problem which could escalate if appropriate steps are not taken now. (page 3, final paragraph)
Source: http://www.taintedblood.info/tlfiles/Council of Europe Lisbon 16 to 19 May 1983.pdf
Type: Extracts of an Informal Report by Dr H. H. Gunson on the Proceedings of the 6th Meeting of the Council of Europe, held in Lisbon, 16th-19th May, 1983.
Location: Lisbon
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1983, 18 May - UK Haemophilia Society - An Appeal Not to Ban Imported Blood Products
The Haemophilia Society appeals to the UK Government not to ban imported blood products and urges patients not to stop treatment in response to concerns over potential risks.

Click here to read the original Sun article for 18 May 1983

Source: link; Toulson L. US Gay Blood Plague Kills Three in Britain. The Sun. 18 May 1983.
Type: Haemophilia Society Appeal
Location: UK
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1983, 20 May - Dr Luc Montagnier - Isolation of LAV
A group of scientists headed by Dr Luc Montagnier, a French Virologist, isolate LAV (lymphadenopathy-associated virus); a new retrovirus that might cause AIDS.
Source: Krever Commission Report, Vol 3, Part IV, International Milestones: HIV and AIDS 1981-8.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=6189183
Additional Source:
http://en.wikipedia.org/wiki/Luc_Montagnier
Type: Article (Science)
Location: France
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1983, 23 May - Dr Bloom - Recommendation that Imported US FVIII Meets New FDA Regulations
In a letter of 23 May, 1983, Professor A. L. Bloom writing to Dr Bolton states the following:

"I do not think that anyone is complacent about the situation but I think that we all agree that it would be counter-productive to ban the importation of blood products at this moment." (Line 6)

Prof. Bloom: "We are however taking steps to recommend that imported products from the U.S.A. at least meet with the new F.D.A. regulations." (Line 8)

"Your comments about the use of cryoprecipitate and N.H.S. factor VIII concentrate have been incorporated into our advice although at the moment we are not rigidly differentiating between cryoprecipitate and N.H.S. concentrate as far as severely affected patients are concerned at any rate." (end of line 9)

Note: It seems that this recommendation, that imported blood products from the US meet the new post-March 1983 FDA Regulations, was not adhered to. WHY did Physicians decide to keep using the 'pre-March 83' high-risk concentrates?

Source: http://www.taintedblood.info/tlfiles/Dr A L Bloom Letter ref FDA 23 May 1983.pdf
Type: Letter, Professor A L Bloom writing to Dr F. E. Bolton. 23rd May 1983.
Location: UK
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1983, 31 May - Stocks of Pre-24th March 1983 Factor VIII Awaiting Batch Clearance by NIBSC
In a Paper on the background of AIDS in May 1983, it transpires that there are large stocks of Factor VIII awaiting batch clearance by NIBSC. It is stated that:

"..this almost certainly includes material made from pre - 24th March plasma." (Page 1, point 2).

"MB4 advise that all FVIII concentrates are subject to full "Stop Orders", which require the manufacturers to submit protocols and samples from every batch they propose to sell in the UK, to Dr Duncan Thomas's department at NIBSC." (Page 1, point 2).

"The content of an individual manufacturer's protocol is very much a matter for agreement between Dr Thomas and the company. Date of plasma collection is thought not to be a requirement at present, but probably could become so if it were thought desirable." (Page 1, point 2).

Note: We are completely dismayed to discover that people knew that stock-piled imported Factor VIII almost certainly included material made from pre-24th March '83 plasma.

Source: http://www.taintedblood.info/tlfiles/AIDS Background Paper III 31 May 1983.pdf
Type: Recovered Document - AIDS Background Paper III. Dated 31st May 1983.
Location: UK
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1983, before 3rd June - Discussion of Unethical Trials Involving PUPs & Mild Haemophiliacs
In a DHSS background paper on the implications of heat-treated Factor VIII concentrates, we learn that a number of commercial manufacturers are hoping to introduce their heat-treated products and that there is a need for controlled clinical trials of heat-treated concentrates with respect to hepatitis infectivity.

"However, such a trial could pose ethical problems at the present time."

Note: We would like to point out that these clinical trials were being considered at a time that we would describe as the heart of the AIDS crisis. Only 3 months earlier, the PHLS were actively looking for Previously Untreated Patients (PUPs) and inviting approaches from commercial firms (March 1983). We know from documented evidence that the PHLS were strongly considering exposing previously untreated patients to hepatitis for the sake of 'meaningful' trials. This is especially unethical, since Dr Craske (PHLS) had knowledge of AIDS in relation to clotting factors from as early as 13th September 1982.

"In earlier discussions on a protocol for such a clinical trial, Haemophilia Centre Directors had been of the opinion that a meaningful trial could only be conducted in patients who had not previously been treated with Factor VIII ie newly diagnosed mild haemophiliacs. However, this is a particular group of patients for whom the Directors have recommended that only NHS material should be used."

Note: It should be pointed out that only 1 month later, we learn in a DHSS letter to Manchester Regional Transfusion Centre, (July 1983), that 3 chimpanzees went on to develop hepatitis after having been injected with Hyland Factor VIII - which had supposedly been heat-treated.

Source: DHSS Background Paper IV. Prior to 3rd June 1983.
http://www.taintedblood.info/tlfiles/DHSS Paper IV Implications of HT FVIII June 1983.pdf
Type: DHSS Paper IV on the Implications of Heat-treated Factor VIII Concentrates. Circa 3rd June 1983.
Location: UK
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1983, 2 June - Dr M. D. Williams - Coventry & Warwickshire Hospital
A letter is sent to parents in the Coventry area by Dr M.D. Williams, Registrar in Haematology stating: "We are sure that you would be aware of the recent publicity about AIDS and the possible risk of this occurring in haemophiliacs using Factor VIII concentrate and we would like to monitor all our haemophiliacs because of this and we would therefore be grateful if you and your child could attend the Blood Bank for a blood test."

Note: This letter suggests that some sort of early blood test was available for HIV (probably termed HTLV-III) as early as June 1983. The date of the test is June 30th at Walsgrave Hospital Blood Bank, and the letter goes on to offer the results by 11 July 1983, which is just 11 days later.

Source: Letter dated 2nd June 1983 from M. D. Williams of Coventry & Warwickshire Hospital
http://www.taintedblood.info/files/CWH_Blood_Test_Letter.pdf
Type: Letter
Location: UK
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1983, 6 June - Diana Walford - Internal Correspondance from DHSS
In a "Chronology - Blood Products/Haemostatic Agents and Hepatitis C/NANBH" submitted to court to assist the Judge, Professor Geoffrey Savidge listed the following:

Internal Correspondence from DHSS - Diana Walford dated 6 June 1983. Under the general heading "Possible Implications of AIDS for Plasma Supply and Manufacture at BPL:

"There are increasing indications that the AIDS may be transmitted by blood and blood products. Because of the number of donations to which they are exposed, haemophiliacs receiving large pool factor VIII concentrates (such as that manufactured at BPL) might be at greater risk than those receiving single donor cryoprecipitate or small pool products. At a recent Council of Europe meeting (16-19 May 1983) a draft resolution was accepted which recommends that the use of coagulation factors prepared from large plasma pools should be avoided except where such a product is specifically indicated for medical reasons. The implication in the resolution is that there should be greater use of single donor or small pool products."

Note: We have been unable to find this internal correspondence of 6th June 1983 in any of the FOI releases. We have also been unable to identify it in the evidence submitted to the Penrose Inquiry, and there is no mention of it in either the Preliminary Report or the Final Report. Therefore, we question whether it was ever released? ...

Source: Chronology - Blood Products/Haemostatic Agents and Hepatitis C/NANBH
http://www.taintedblood.info/files/1458091556Chronology_1965_1983_Prof_Savidge.pdf
Type: Submission by Professor G Savidge
Location: UK
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1983, 9 June - Government Election
The Conservatives are in power for a second term with Margaret Thatcher as Prime Minister.
Source: http://en.wikipedia.org/wiki/Margaret_Thatcher
Type: Political climate
Location: UK
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1983, 13 June - Half of Factor VIII Used in the UK is Imported Concentrate - Mostly from USA
In an DHSS circular of 13 June 1983, it is evident that as much as 50% of the Factor VIII material required for the United Kingdom is large-pool imported commercial concentrate, mostly from the USA.

NHS single-donor cryoprecipitate 17%
NHS large-pool FVIII concentrate33%
Imported large-pool (mostly USA) FVIII concentrate50%

The DHSS circular continues:

"From these figures it can be seen that there is no option but to treat the majority of our haemophiliacs with large-pool products and thus it could be argued that the use of such products is specifically indicated for medical reasons since the risks of non-treatment are greater than the risks of treatment. However, this is a rather dubious 'let-out' and I think we should prefer to see the recommendation re-worded viz:"

  • To avoid wherever possible [practicable] the use of coagulation factor products prepared from large plasma pools: this is especially important for those countries where self-sufficiency in the production of such products has not been achieved.
"On the latter point, the implication is that the need to avoid large-pool products may be lessened if a country is self-sufficient in blood products."

It is clear from these comments that there were attempts within the DHSS at 'skin-saving' and possibly cost-cutting apparently designed to mitigate or even circumnavigate the draft recommendations of the Council of Europe.

(See Related Entries link below for an astounding Kenneth Clarke comment made only 5 months later.)

Source: http://www.taintedblood.info/tlfiles/Half of UK FVIII Needs are US Imported Product 13 June 1983.pdf
Type: DHSS Circular from MED SEB, Room 1025A Hannibal House. Dated 13 June 1983.
Location: UK
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1983, 21 June - AIDS Appeared to be Transmitted Through Blood & Blood Products
In the Minutes of the CBLA (Central Blood Laboratories authority), Central Committee for Research and Development in Blood Transfusion, held on 21 June 1983, we can learn more about when the DHSS actually started to make the link between AIDS transmission and blood and blood products:
"The Chairman outlined the problems caused by AIDS. Since it appeared to be transmitted through blood and blood products then it should be considered by the Committee."

Note: We note that Dr Diana Walford (on behalf of the DHSS) was present at this meeting.

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1983, 24 June - Bloom - Rizza - Restriction of US Imported Factor VIII Unwarranted Except in Children
In a letter of 24th June 1983, Arthur Bloom and Charles Rizza of the Oxford Haemophilia Centre refer to a previous meeting of May 13th 1983 in which the following general recommendations were agreed:

1. "For mildly affected patients with haemophilia A or von Willebrand disease or minor lesions, treatment with DDAVP should be considered. Because of the increased risk of transmitting hepatitis by means of large pool concentrates in such patients, this is in any case the usual practice of many Directors."

2. "For treatment of children and mildly affected patients or patients unexposed to imported concentrates many Directors already reserve supplies of NHS concentrates (cryoprecipitate or freeze-dried) and it would be circumspect to continue this policy."

"It was agreed that there is as yet insufficient evidence to warrant restriction of the use of imported concentrates in other patients in view of the immense benefits of therapy but the situation will be constantly reviewed."

Source: http://www.taintedblood.info/tlfiles/24 June 1983 Oxford Letter Blood Rizza.pdf
Type: Letter from A. L. Bloom and C. R. Rizza to Haemophilia Centre Directors. Dated 24th June 1983.
Location: UK
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1983, 29 June - NBTS - Heat Treated Factor VIII - Extrapolated Too Far by FDA
In a letter from the National Blood Transfusion Service to the DHSS in June 1983, it is clear that the NBTS, Manchester, considered the F.D.A. to be extrapolating the effectiveness of heat-treatment 'too far' with respect to AIDS; since the agent may not be killed by the heat-treatment process. They knew that that some of the chimpanzees had developed hepatitis but that the incubation period had been prolonged.

Paragraph 3: "Also, I expect we will find this material will be double the cost of the unheated Factor VIII and if demands are made for its use by either Haemophilia Directors or possibly the patients themselves, if they hear or read about it, it will play havoc with the R.H.A.'s finances."

Source: http://www.taintedblood.info/tlfiles/NBTS Heat Treated Factor VIII RHA Finances 29 June 1983.pdf
Type: Recovered Document - National Blood Transfusion Service. Letter to DHSS. Dated 29th June 1983.
Location: UK
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1983, July - Dr Edgar Engleman of Stanford University Blood Bank
Dr Edgar Engleman introduces T-cell testing at the Stanford University blood bank. The test is difficult to implement because the equipment is costly and the test has to be performed manually, but Stanford is conducting immunological research at the time and has the necessary laboratory equipment.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 762.
Type: T-Cell testing introduced
Location: USA
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1983, 1 July - DHSS - Hyland Heat-Treated Factor VIII Transmits Hepatitis to 3 Chimpanzees
In a DHSS letter of July 1983 to Manchester Regional Transfusion Centre, it is stated that 3 chimpanzees went on to develop hepatitis after having been injected with Hyland Factor VIII - which had supposedly been heat-treated.

The DHSS, in reply to the RTC states:

"...However, your comments about the potentially major financial consequences for health authorities, in the event of unjustified demands for this material being made, could be used to support the argument for the need for properly controlled clinical trials before such material is introduced into this country."

Source: http://www.taintedblood.info/tlfiles/DHSS Hepatitis in 3 Chimpanzees 1 July 1983.pdf
Additional source:
http://www.taintedblood.info/tlfiles/Letter from DHSS 1 July 1983.pdf
Type: Recovered Document - DHSS Letter to Manchester RTC. Dated 1st July 1983.
Location: UK
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1983, 13 July - Committee on Safety of Medicines - Biologicals Sub-Committee
The Biologicals Sub-Committee of CSM recommends that very little is done about the threat of AIDS to haemophiliacs.
  • The possibility is considered of withdrawing clotting factor concentrates from the market and replacing them with cryoprecipitate. It is concluded that this is not feasible in the UK on grounds of supply. (Minutes Agenda Point 5.3)
  • The possibility is considered of withdrawing US preparations from the UK. It is concluded that this is not at present feasible on grounds of supply. Moreover, the perceived level of risk does not at present justify serious consideration of such a solution. (Minutes Agenda Point 5.4)
Source: http://www.taintedblood.info/files/Biologicals%20Subcommittee%20of%20CSM%20July%201983.pdf
Additional Sources: Haemophilia HIV Litigation, Advice on Settlement Doc., pp 56-58.
http://www.guardian.co.uk/society/2007/may/25/health.politics
Type: Minutes - Committee on Safety of Medicines
Location: UK
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1983, 13 July - CSM - Biologicals Sub-Committee - Possible AIDS Risk from Hepatitis B Vaccines
In a meeting of the Biologicals Sub-committee of the CSM, the safety of Hepatitis B vaccines are considered. Although there is no evidence at this time of any risk from vaccine material licensed in the UK, the Committee recommends that manufacturers be asked to provide ongoing data relating to "the safety of the product in relation to AIDS".

It is understood that ARVI have recommended that the PHLS undertake surveillance of recipients of Hepatitis B vaccine.

Source: CSM Sub-Committee on Biological Products, Meeting Minutes, agenda point 5.8. 13 July 1983.
http://www.taintedblood.info/files/Biologicals%20Subcommittee%20of%20CSM%20July%201983.pdf
Type: Minutes - Committee on Safety of Medicines
Location: UK
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1983, 13 July - Committee on Safety of Medicines - Biologicals Sub-Committee
In a meeting in July 1983, the Biologicals Sub-Committee of CSM is aware of clotting factor manufacturers preparing advertising material for use within the UK that makes unjustified claims regarding safety in relation to heat-treated factor VIII. Fears are expressed by the Sub-Committee that the unlicensed material might be used in trials on a 'named-patient' basis.(Minutes Agenda Point 5.7, page 3)
Source: Committee on Safety of Medicines.
http://www.taintedblood.info/files/Biologicals%20Subcommittee%20of%20CSM%20July%201983.pdf
Type: Minutes - Committee on Safety of Medicines (CSM)
Location: UK
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1983, 13 July - Introduction of this Disease into the Virgin Soil of the United Kingdom
In the summary of main points from a consideration of AIDs in relation to licensed blood products by the Committee on Safety of Medicines (Biologicals Subdivision) in July 1983, we read the following:

"There is need for research work on AIDS in the UK, especially in relation to the possible new introduction of this disease into the virgin soil of the United Kingdom.
The Sub-Committee was glad to learn that a number of groups, including the Medical Research Council, are planning and have started research work."

Note: We fail to understand why they talk about the "possible new introduction of this disease". Are we to believe that they somehow helped introduce it to the UK?

Source: Para 11, Summary of Main Points from A Consideration of Aids and Licensed Blood Products by CSM(B) 13 July 1983
http://www.penroseinquiry.org.uk/pdf/DHF0028865.PDF
Type: Penrose Evidence File
Location: UK
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1983, 19 July - FDA BPAC Meeting - Donor Identification
In a meeting in July 1983, the recommendations of the FDA Blood Products Advisory Committee (BPAC) for a general recall are successfully deferred by the US pharmaceutical blood companies who act together to lobby the FDA to limit recalls to circumstances in which a donor is identified. This joint action allows the US blood companies to avoid ever recalling any product except when a donor dies of AIDS.
Source: Class Action Complaint (2004) Case No. C032572 PJH Page 40
Type: Meeting
Location: USA
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1983, 19 July - Institute of Medicine Committee Findings (FDA / BPAC Meeting)
With regard to the Blood Products Advisory Committee meeting of 19 July 1983, the Institute of Medicine Committee concludes that the FDA failed to conduct any independent risk-benefit analysis of an automatic recall policy, but based its conclusions solely on the recommendations of the Blood Products Advisory Committee. It adopted a poorly conceived "non-policy", which in the view of the Institute of Medicine committee should have been rejected in favour of a more positive approach.

The Institute of Medicine Committee believes it is not possible to conclude that the FDA made a decision that was clearly in the interest of public health given available information as of July 19, 1983. A close reading of the data suggests that a policy, not only of automatic recall, but of delicensing AHF (anti-hemophilic factor) concentrate until further information was available concerning its role in the transmission of AIDS might have been justified on public health grounds.

Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 759-760.
Type: Committee findings
Location: USA
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1983, Summer - T-Cell Testing
T-cell testing is now sufficiently reliable to form the basis of numerous reliable studies and conclusions about AIDS in US hemophiliacs and other risk groups.
Source: Class Action Complaint (2004) No. C032572 PJH, page 30.
Type: T-Cell testing development
Location: USA
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1983, Summer - Cutter Analysis
Cutter conducts an analysis which acknowledges the risk of 2,000 to 5,000 hemophiliac deaths in the United States due to AIDS transmission through factor concentrates.
Source: Class Action Complaint (2004) No. C032572 PJH, page 30.
Type: Analysis
Location: USA
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1983, 27 July - Concerns Over Blood Collection from Prisons and Borstal Institutions
In a DHSS Circular from 27 July 1983, we learn that the Medicines Division's Inspection Action Group has concerns about the collection and use of blood from borstal institutions and prisons.

"The group considered this practice to be highly questionable because of the incidence of homosexuals and homosexual activity in prisons and the present unease about the incidence of AIDS among this group of people. The Group asked to be advised of Departmental policy on the practice of collecting and using blood from borstals and prisons."

Note: We have now found definite proof that prison blood was being used by Scottish and English Transfusion Centres. We are concerned to learn that Blood Transfusions Centres in Scotland were taking blood from borstal and prison sources and at least some of the English Blood Transfusions Centres were also receiving blood from these sources.

Background: We should point out that serious concerns were raised in the UK in 1980 over the safety of using blood from Scottish prisoners in NHS transfusions - and this was hardly the first warning. There were international warnings from as early as 1958, from Dr. J. Garrott Allen, who after having conducted a survey in the Chicago area, discovered what he referred to as the "prison effect".

We are dismayed to learn that blood was taken from UK prisons and borstal institutions right up until March 1984 - well after prisoners were considered to be high-risk donors. WHY did the Authorities persist with taking blood from prisons?

The following is a quote from a document released under FOI: "Furthermore it is socially and psychologically undesirable to exclude prisoners and volunteers from tropical areas from the donor population. Acceptance of prisoners as donors helps to rehabilitate, and some of these volunteers become regular donors after their release."

Source: DOH Freedom of Information Documents Released July 2007. Volume 30, page 2.
http://www.taintedblood.info/tlfiles/DHSS Letter on Use of Prison Blood 27 July 1983.pdf
Type: DHSS Circular from HS1 MB2
Location: Scotland
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1983, August - CDSC - First UK report of AIDS in a person with Haemophilia
The first report of AIDS in a UK haemophiliac is reported by the Communicable Disease Surveillance Centre. A patient from Wales had received factor VIII concentrate imported from the United States.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 33, page 927.
Type: Report
Location: UK
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1983, circa August - DHSS - Lord Glenarthur - Decision Not To Ban Pre-March 1983 US Factor VIII
In a DHSS letter from The Lord Glenarthur to Clive Jenkins Esq., the following is stated in reference to the continued importing of high-risk pre-March 1983 factor VIII stock:

"Although future supplies of FVIII both for export and for use in America will of course be manufactured from plasma collected in accordance with these regulations, there is still a quantity of stock, some already in this country and more in America awaiting shipment here, which has been made from 'pre-March' plasma" (Paragraph 4, line 3)

"We have to balance the risk of AIDS against the severe risks to haemophiliacs of withdrawing a major source of supply of Factor VIII which cannot be made good from elsewhere in sufficient volume." (Paragraph 4, line 9)

"Haemophilia Society is aware of the situation and has in fact made known to me its opposition to any move to ban American FVIII." (Paragraph 4, last 2 lines.)

Background: The mention of 'pre-March' plasma is a reference to the point in March 1983 where the FDA introduced new regulations for the collection of plasma that excluded donors from high-risk groups. It should be remembered that any plasma intended for FVIII products was likely to have been collected up to 2 years previously. Therefore, even as the FDA restriction came in around March 1983, the products available then could have been made from high-risk 1981-2 plasma.

Note: It is also worth noting that it should have been possible for cryoprecipitate to have been used instead of high-risk Factor VIII - at least until alternative arrangements could have been made, except the production facilities for cryo in the UK were no longer adequate. Just 1 month earlier, in a July meeting of the CSM, the possibility was considered of withdrawing clotting factors from the market and replacing them with cryoprecipitate, except it was concluded that this was not feasible in the UK on grounds of supply. (CSM Minutes Agenda Point 5.3, see additional source below)

Source: http://www.taintedblood.info/tlfiles/DHSS Lord Glenarthur Clive Jenkins Letter August 1983.pdf
Additional Source:
http://www.taintedblood.info/files/Biologicals%20Subcommittee%20of%20CSM%20July%201983.pdf
Type: Recovered FOI Document - DHSS letter from the Office of the Joint Parliamentary Under Secretary of State. Circa August 1983.
Location: UK
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1983, August - First UK haemophiliac dies of AIDS
First UK haemophiliac dies of AIDS from US Factor VIII administered in December 1981.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Development
Location: UK
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1983, September - HCDO - Heat Treated Factor VIII - Types Available for Clinical Trials
A memorandum is circulated to all Haemophilia Centre Directors informing them of the types of heat-treated factor VIII concentrate that will be available for clinical trials in 1983-4.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 33, page 931, paragraph 3.
Type: Memorandum
Location: UK
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1983, September - Hyland Product Recall
In September 1983, lots (batches) of Hyland factor IX and Red Cross factor VIII are recalled.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 770.
Type: Product recall
Location: USA
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1983, September - Dr Montagnier (French team)
The French team, led by Dr Montagnier, presents its findings to North American researchers at a conference held in Cold Spring Harbor, New York, and suggests that LAV is responsible for AIDS.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 756.
Type: Findings
Location: USA
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1983, 1 September - DHSS
DHSS publishes 1st blood donor leaflet.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Donor leaflet
Location: UK
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1983, September - Barcelona Congress - Furious Exchanges about Leftover Unheated Stock
At a meeting of the 7th Congress of the European Society of Haematology in Barcelona in September 1983, there were representatives from commercial companies present, along with haemophilia experts from across Europe:

Two of those present told the BBC of furious exchanges over what to do with leftover non-heat-treated factor VIII. There was talk of certain countries agreeing to take-on those leftover stocks and even talk of money available from 'grateful' commercial companies to support research. Some of those present were shocked and objected, others were more sympathetic.

Source: BBC Newsnight 17 Apr 2007
http://news.bbc.co.uk/player/nol/newsid_6560000/newsid_6566300/6566349.stm?bw=bb&mp=rm
AIDS, hepatitis and hemophilia in the 1980s (see last 3 lines pg 3)
http://www.blackwell-synergy.com/doi/pdf/10.1046/j.1538-7836.2003.00483.x
Type: Citation from Footage of BBC Newsnight, aired Tuesday 17th April 2007.
Location: Barcelona
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1983, 12 September - Connaught / Arkansas - Use of Plasma from U.S. Penitentiaries
In an inter-office memorandum of September 1983 from Connaught Laboratories Limited, under the subject heading: "Use of Plasma from U.S. Centres located in Penitentiaries", it states that:

"Only a few penitentiaries are still being licensed. They are exclusively in the Southern States, including Florida, Louisiana, Mississippi and Arkansas. The respective States' Department of Correctional Services requests the licensing to continue as a moral booster for the inmates."

"Since these centres are licensed and inspected as any other plasmapheresis centre, it is NOT ILLEGAL to use this plasma for the production of fractionation products for HUMAN USE. It is, however, considered MOST IMPRUDENT."

On page 2, under "A.I.D.S. Risk:" the memo states "The Coagulation Factors present a definitive risk."

Note: Surprisingly, under the risk for hepatitis B, they state that in the case of Factor VIII and IX that these should not be released if the plasma pool contains a hepatitis B positive unit or an untested unit.

Rather alarmingly, the memorandum mentions a definitive risk from AIDS, but it does not state that the coagulation factors should be discarded if the plasma pool contains material from a donor subsequently implicated with AIDS.

Source: Memorandum courtesy of Kelly Duda's Factor 8 Movie website
http://www.factor8movie.com/factor8.htm
http://www.taintedblood.info/tlfiles/Connaught Document.pdf
Type: Memorandum from J.C.W. Weber of Connaught Laboratories Limited dated 12 September, 1983
Location: USA
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1983, 14 September - CSM Sub-Committee on Biological Products / Travenol - Hemofil
The CSM Sub-Committee on Biological Products declines a Product Licence to Travenol Limited for Factor VIII (PL 0116/0011 HEMOFIL). Travenol fails to present information that adequately shows the safety and efficacy of the product and that adequately characterises the product in terms of heat-treatment. They also fail to provide justification of the inclusion and choice of heat treatment process.

Note: Travenol are strongly criticised by the Sub-Committee for writing promotional letters making unjustified claims on improved safety margins in respect of AIDS infection.

Source: Minutes of the Committee on the Safety of Medicines - Sub-Committee on Biological Products. Appendix D. 14 September 1983.
http://www.taintedblood.info/files/CSM_14_September_1983.pdf
Type: Product Licence Refusal
Location: UK
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1983, 19 September - DHSS Memorandum - Early Discussion of Genetically Engineered Factor VIII
In a DHSS memorandum regarding a meeting of the Haemophilia Reference Centre Directors on 19th September 1983, we read of further mention of the possibility of genetically-engineered Factor VIII.

Under point 6, it states: "I discussed genetically engineered FVIII - still about 10 years off, is the guess." (Page 2, point 6.)

Note: This estimate of genetically engineered factor VIII being 10 years off was too generous. Somehow, within just 4 years, Hyland (Baxter) had managed to begin human clinical trials of a recombinant Factor VIII concentrate. (See additional source below).

Source: http://www.taintedblood.info/tlfiles/DHSS Discussion of Genetically Engineered FVIII 19 September 1983.pdf
Additional Source: Hyland (Baxter) Milestones
http://www.baxtervaccines.com/?node_id=1247
Type: Recovered Document - DHSS memorandum (ref. cloning). Hannibal House Room 1025A. Dated 19th September 1983.
Location: UK
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1983, 10 October - DHSS - Government Feigns International Search for AIDS-Free Blood Products
The following text is a transcript of a faint copy of a recovered DHSS letter of October 1983 with the heading "AIDS in Blood Products":

"I refer to your minute of 7 October to Dr [Name]. I note you will be considering with Dr [Name] how best to approach other countries about the availability of "AIDS-Free" Factor VIII. I would myself have thought it ill-advised to tackle this through the WHO since we are taking a very independent line which may in fact not necessarily be approved of by the WHO. What if all countries adopted our approach? In fact I do not think we need go too far in exploring the availability of suitable products from elsewhere. Surely it would be sufficient to approach two or three of the "respectable" large countries who have volunteer donor panels to see what they say. If we suspect the answer was negative our approach need go no further." (Transcript of Letter 10 October, 1983)

In an earlier letter of 7 October 1983, the DHSS states: "We are all aware, I think, that this global approach is purely cosmetic (as, indeed, is the letter to the Swiss Red Cross, but this is a rather special case)."

Note: Was the Government only going through the motions in October 1983 by appearing to look for AIDS-free factor VIII from other countries? Britain had its own voluntary donors. The Government had already been told by WHO and the PHLS not to import blood products; and without a test for Aids available, how could any country in the world know that their donors were safe?

Source: DHSS Letter 10 October, 1983:
http://www.taintedblood.info/tlfiles/DHSS AIDS-Free FVIII 10 October 1983.pdf
DHSS Letter 7 October 1983:
http://www.taintedblood.info/tlfiles/DHSS AIDS In Blood Products 1983.pdf
Type: Recovered Documents - DHSS Letter 10 October, 1983 and DHSS Letter 7 October 1983
Location: UK
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1983, 10 October - MRC Working Party - Controlled AIDS Study of UK Haemophiliacs
In an October 1983 meeting of the Medical Research Council, the Chairman, Dr Tyrrell, indicated the need to ensure that the best use be made of the special combination of suitable patients for study and the clinical, immunological, virological and other expertise that was available in the United Kingdom:

"The special features arising in relation to haemophilia were discussed and the possibility of identifying the role of imported Factor VIII concentrate used for UK patients was outlined. There followed discussion on the varying and considerable period of incubation (1 to 4 years) and the possible relationship between the size of inoculum of the PROPOSED AGENT and the length of latency." (page 2, point 3a, line 14)

"It was noted that blood product associated cases could enable some of these alternative hypotheses to be tested." (page 3, end of paragraph 4)

O"pportunities Special to the United Kingdom:"
"The Working Party sought to identify particular opportunities for research unique or special to the United Kingdom. The fact that the epidemic was lagging some three years behind that in the USA was considered an important factor in enabling the background against which AIDS develops to be delineated. This could enhance our ability to detect the emergence of AIDS and virological status of the high risk groups. The underlying immunological and virological status of the high risk groups BEFORE they encountered the "AIDS agent" could thus be defined." (page 4, point 4)

"The UK system for haemophilia treatment and for blood product organisation would allow detailed study of haemophilia associated cases which has not been possible in the USA due to their system of record keeping and organisation." (page 4, end of paragraph 3)

"The organisation of epidemiology in the United Kingdom was well suited to studying this problem. The importance of establishing such studies early in the emergence of disease was again stressed." (page 4, final paragraph, line 5)

"It was noted that in addition the UK offered particular opportunities to pursue carefully controlled and monitored therapeutic trials." (page 5, paragraph 2)

"It was thought that suspect blood products could provide valuable raw materials for work of this type. Indeed, the possibility of fractionating blood from patients with "pre-AIDS" in order to concentrate the agent was a notable suggestion." (page 5, paragraph 4, line 10).

Source: http://www.taintedblood.info/tlfiles/MRC Minutes October 1983.pdf
Type: Minutes - Medical Research Council Working Party on AIDS. Dated Monday 10th October 1983.
Note: The following departmental observers were present at this MRC meeting: Dr W. M. Prentice (SHHD) and Dr Diana M. Walford (DHSS)
Location: UK
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1983, 17 October - UKHCD - Early Knowledge of Risk of AIDS to Spouses of Haemophiliacs
In the notes of the 14th Meeting of the UK Haemophilia Centre Directors on 17th October 1983, it is clear that the Directors have early knowledge of the risk of AIDS to spouses of haemophiliac patients:

Under the heading "AIDS UK Situation" the following is stated:

"Spouses of patients who received FVIII will also be followed. Choice of control group for the above study not decided as yet but is considered critical to the study." (Page 1, circa line 21)

On page 4, under the heading "U.K. Situation", the minutes state:

"Twenty-two patients have N.I.H diagnostic criteria for AIDS - many through contact in USA. 10 patients have so far died. Details of haemophiliac cases (A1 and A4) are contained in Appendix B and the follow-up protocol is to be circulated in due course."

The following comment, made during the AIDS crisis also doesn't bode well:

"...Neither Dr Boulton, Dr Ludlam or myself considered it appropriate to discuss publicly the details of our current 'clinical trial' on heat treated FVIII" (Page 1)

Note: Rather than focussing on control groups and studies, it would have been prudent and more ethically sound to commence an immediate notification exercise with the imparting of advice to the spouses of patients with haemophilia.

Source: http://www.taintedblood.info/tlfiles/UKHCD Minutes October 1983.PDF
Type: Notes of the 14th UKHCD Meeting, Oxford RHA. Dated 17th October 1983
Location: UK
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1983, 17 October - Haemophilia Centre Directors Meeting - Unlimited Supplies of Cryoprecipitate
In the minutes of the 14th meeting of the UK Haemophilia Centre Directors' Organisation on Monday, 17th October 1983, the following is stated regarding "unlimited supplies of cryoprecipitate":

"Dr. Chisholm raised the problem of patients refusing to take up commercial factor VIII concentrate because of the AIDS scare. She wondered in view of the worry of the patients whether the Directors could revert to using cryoprecipitate for home therapy."

"Professor Bloom replied that he felt that there was no need for patients to stop using the commercial concentrates because at present there was no proof that the commercial concentrates were the cause of AIDS. Dr. Chisholm pointed out that there was a further problem in her region because of problems in getting large amounts of commercial concentrates whereas she could get unlimited supplies of cryoprecipitate."

"Other Directors reported that they had the same problems. After discussion it was agreed that patients should not be encouraged to go over to cryoprecipitate for home therapy but should continue to receive the NHS or commercial concentrates in their usual way."

Background: This mention of an 'unlimited' availability of cryoprecipitate, right in the middle of the AIDS crisis in October 1983, demonstrates that there were viable, much safer alternatives for haemophiliacs in the UK.

Note: This statement regarding unlimited availability of cryoprecipitate directly contradicts what was stated in the 13th July 1983 meeting of the Biologicals Sub-Committee of the CSM. During that meeting, those present considered the possibility of withdrawing US clotting factor concentrates from the market and replacing them with cryoprecipitate, but they hastily concluded that this was not feasible in the UK on grounds of supply. (CSM Minutes, Agenda Point 5.3, 13th July, 1983.)

Source: http://www.taintedblood.info/tlfiles/HCDO Complete Minutes 17th October 1983.pdf
Additional source:
http://www.taintedblood.info/files/Biologicals%20Subcommittee%20of%20CSM%20July%201983.pdf
Type: Minutes. UK Haemophilia Centre Directors Organisation, dated Monday, 17th October 1983.
Location: UK
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1983, 17 October - UK Haemophilia Centre Directors - Possibility of Artificial Factor VIII
In the minutes of the 14th meeting of the UK Haemophilia Centre Directors on 17th October 1983, the possibility of the production of artificial factor VIII is discussed:

"The question of the production of an artificial source of factor VIII in the near future (that is within the next two to three years) was raised and discussed. Professor Bloom said that he thought that there was still a lot of work to be done on this type of product before any material would be available for use in patients and it was not likely to be available in the near future." (Page 7, final paragraph)

Source: http://www.taintedblood.info/tlfiles/HCDO Complete Minutes 17th October 1983.pdf
Type: Minutes of the 14th Meeting of the UKHCDO. Oxford, Monday 17th October 1983.
Location: UK
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1983, 20 October - Memorandum - Baxter
Baxter, unbeknownst to the FDA, continues to use prison plasma in factor concentrate production until October 1983, despite having entered into an agreement with the FDA (11 months earlier), that they would no longer use US prison plasma.
Source: Class Action Complaint (2004) Case No. C032572 PJH. Page 24.
Additional Source: Baxter Memorandum dated 20th October, 1983.
Type: Memorandum - Baxter
Location: USA
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1983, 24 October - Mr Kenneth Clarke - Minister for Health - No Imports of Human Blood Plasma?
Mr Kenneth Clarke: "As far as I know no human blood plasma is imported into the United Kingdom by the NHS."

"Over the next three years the blood products laboratory will be redeveloped at a cost of 21m. When completed the laboratory will be of a size capable of making England and Wales self-sufficient in blood products".

Note: Mr Kenneth Clarke has clearly made the most of the way in which the original question was worded. This is a crafty answer, in that if the question had specified 'blood products' then he would have had to divulge information that indicated that blood products have, in fact, been imported into the United Kingdom since 1972. (Source: "Haemophilia Treatment in the United Kingdom from 1969 to 1974" Rosemary Biggs)

Background: There was no question that blood products (as opposed to plasma) were being imported from the USA when Mr Kenneth Clarke made this statement in 1983:

  • In August 1983, Lord Glenarthur of the DHSS failed to ban pre-March 1983 imported American factor VIII. "Regarding blood products from the USA, in March this year the US Food and Drugs Administration (FDA) initiated new regulations for the collection of plasma designed to exclude donors from high-risk groups."
  • It should also be pointed out that the MHRA's CSM (Committee on the Safety of Medicines) sub-Committee on biological products were reviewing product licences between March 1983 and July 1984 for commercial companies Armour, Alpha and Travenol with respect to their factor VIII products and antihaemophilic factor bulk cryoprecipitate.
  • Five months earlier, (June 1983), written evidence can be found from the DHSS that as much as 50% of the Factor VIII requirements of the United Kingdom were indeed imported large-pool commercial concentrates, mostly from the USA.
Source: http://www.taintedblood.info/timeline.php?mode=related&id=17
Mr Kenneth Clarke. Hansards Written Answers: Vol 47, 1983/84, October 24th to November 4th
http://www.taintedblood.info/tlfiles/DHSS Lord Glenarthur Clive Jenkins Letter August 1983.pdf
Type: Hansards Written Answers
Location: UK
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1983, late October - Cutter (& NHF Response)
Cutter orders a recall after being notified that a donor has died of AIDS in Texas. The donor died within 30 days of his last donation and the donor's plasma was used in numerous batches of Factor VIII and IX in the previous 2 years.

Note: In response to Cutter's product withdrawal, the National Hemophilia Foundation astonishingly advises patients to continue the use of concentrates or cryoprecipitate.

Source: Class Action Complaint (2004) Case No. C032572 PJH Page 31.
Additional Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 770.
Type: Product recall
Location: USA
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1983, 27 October - ASTMS Disagrees with the Department's View on the Issue of AIDS
In a reply letter of October 1983 to Lord Glenarthur from the Association of Scientific Technical and Managerial Staffs, it is clear that the Association (ASTMS) does not agree with the Department's view on Acquired Immune Deficiency Syndrome (AIDS):

"You say that there is no conclusive evidence that AIDS is transmitted through blood products. I would argue that the evidence is very strong. There are now about 20 American haemophiliacs with AIDS, and this figure is likely to underestimate the risk because of the apparently long incubation period." (page 1, point 2)

"I also draw your attention to a paper prepared jointly by DHSS staff and the HSE which was submitted to a recent meeting of the Advisory Committee on Dangerous Pathogens (ACDP/83/P9). This paper states quite specifically that "there is now strong circumstantial evidence that AIDS may be transmitted by blood products." I am tempted to ask you what you would consider to be conclusive evidence, particularly in the circumstances where the agent or agents for AIDS are as yet unidentified?" (page 1, point 2)

"I think you are placing undue reliance on the Regulations introduced by the U.S. Food and Drug Administration. These Regulations rely on the use of interviews and questionnaires to identify donors from high risk groups; ...."

"The companies also do not intend to recall contaminated lots after manufactures." (point 3)

"I do not regard the situation concerning "pre-March" plasma to be satisfactory because, in effect, it means that despite the introduction of the above Regulations we are essentially carrying on as before. In such circumstance there must be a real danger that the UK will become a dumping ground for USA companies to get rid of their non-regulated products. I think for this reason your Department should reconsider its rather passive response to the need for Regulations." (Page 3, point 4.)

Source: DOH Freedom of Information Documents released July 2007. Vol 32. Pgs 113-115.
http://www.taintedblood.info/tlfiles/ASTMS Letter 27 October 1983.pdf
Type: Letter to the Lord Glenarthur - Joint Parliamentary Under Secretary of State from the Association of Scientific Technical and Managerial Staffs, ASTMS. Dated 27th October 1983.
Location: UK
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1983, 27 October - ASTMS - Scottish Fractionation Plant Substantially Under-Used
In a letter of 27 October 1983 from the Association of Scientific Technical and Managerial Staffs, it is clear that the ASTMS holds the belief that the Scottish Fractionation plant is substantially under-used and that this appeared to them to be being ignored by the Department.

"...I am advised by my members that PSC could increase its capacity to a level where we could manufacture over two-thirds of the Factor VIII currently purchased from the USA." (page 2, point 5)

Note: We assert that Scotland had the capacity to attain the 1974 'self-sufficiency' target of 40 million units. By 1983, they could have reached the required self-sufficiency target. All the two governments needed to agree on was that Scotland would supply the factor concentrate requirements for the UK until the development of the new English facility came through with genetic 'recombinant' factor products.

The whole of the UK could and should have been using plasma-free products by 1988.

Source: DOH Freedom of Information Documents released July 2007. Vol 32. Pgs 113-115.
http://www.taintedblood.info/tlfiles/ASTMS Letter 27 October 1983.pdf
Type: ASTMS - Association of Scientific Technical and Managerial Staffs Letter to the Lord Glenarthur - Joint
Parliamentary Under Secretary of State. Dated 27th October 1983.
Location: Scotland
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1983, 1 November - Cutter Press Release - No Adverse Reactions
Cutter issues a misleading press release regarding their product recall, stating: "No adverse reactions involving these lots have been reported." This statement is misleading because it was virtually impossible for Cutter to know whether or not any adverse reactions had been experienced at this time.
Source: Class Action Complaint (2004) Case No. C032572 PJH Page 31
Type: Press release
Location: USA
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1983, 14 November - Mr Kenneth Clarke - Evidence that AIDS is Transmitted by Blood Products?
Mr Kenneth Clarke, Minister for Health: "There is no conclusive evidence that (AIDS) is transmitted by blood products."

"The use of factor VIII concentrates is confined almost exclusively to designated haemophilia centres whose directors and staff are experts in this field."

"Professional advice has been made available to all such centres in relation to the possible risk of (AIDS) from this material".

How much proof did he need?

  • In a Haemophilia Centre Directors' Organisation meeting in 13 September 1982, there is not only knowledge of AIDS infecting haemophiliacs in the USA, but also, there is some understanding of the possible involvement of commercial blood products.
  • Then in January 1983, Desforges publishes an articles in the New England Journal of Medicine on Hemophiliacs and AIDS, recommending that cryoprecipitate rather than concentrate be used because of the risk of AIDS.
  • By 6th May 1983, the CDSC telephones the DHSS to inform them that a 23 year old haemophiliac patient in Cardiff is now showing the appropriate symptoms for an AIDS diagnosis. N.b. This man had been infused with American Factor VIII.
  • In a letter of May 1983, Dr N. Galbraith of the PHLS writes to the DHSS stating that he has reviewed the literature and come to the conclusion that all blood products made from blood donated in the USA after 1978 should be withdrawn from use until the risk of AIDS transmission by these products has been clarified. Both this suggestion and warning were ignored.
  • Even when the Council of Europe made their draft recommendations on coagulation factors and AIDS at their meeting in Lisbon (16-20th May 1983), the UK seems to have difficulty remotely following these resolutions - which were, incidentally, accepted. The Council of Europe recommended that the use of coagulation factors prepared from large plasma pools should be avoided except where such a product was specifically indicated for medical reasons.
  • In August 1983, the first UK haemophiliac dies of AIDS from US Factor VIII administered in December 1981.
Source: Hansards Written Answers: Vol 48, 1983/84, 7-24 November, column 328
Type: Hansards Written Answers
Location: UK
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1983, 30 November - Mr John Mackay Secretary of State for Scotland - Common Services Agency
The agreement drawn up by the Common Services Agency includes the provision that blood products supplied by the Blood Transfusion services will not be sold to patients, or to any other establishment either within the United Kingdom or overseas.
Source: Hansards Written Answers, 30 Nov. 1983, Vol 49, Column 513.
Type: Political
Location: Scotland
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1983, December - Dr Johanna Pindyck - Greater New York Blood Program
Dr Johanna Pindyck summarizes the results of anti-core testing done at the Greater New York Blood Program. She reports that 5.5% of male donors under thirty-five years of age are core antibody positive, as were 7.7% of those over thirty-five years. The estimated cost of the test is just $3 US dollars.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 762.
Type: Anti-core testing
Location: USA
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1983, 10 December - Fletcher, et al - NHS Pool Sizes
Fletcher and others in the British Medical Journal conclude that NHS pool sizes are so large as to lose their safety advantage over paid imported blood.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: BMJ
Location: USA
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1983, 10 December - Fletcher, et al - Claims Commercial & BPL Contain Equal Risk...
Studies, such as that by Fletcher et al. confirms that commercial and BPL concentrates contain equal risk of transmitting hepatitis.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Studies
Location: UK
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1983, 13 December - Cutter Memorandum - Hepatitis B Core Test
A memorandum from Cutter's head, Stephen Ojala to various Cutter executives, reports back on a meeting held by all 4 US pharmaceuticals shows that they conspired to propose a "task force" to further study the use of Hepatitis B core test to intentionally delay it's implementation.
Source: Class Action Complaint (2004) Case No. C032572 PJH Page 19
Type: Internal Memorandum (Cutter)
Location: USA
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1983, 15 December - Armour / BPAC / FDA
The head of Armour, Rodell, tells members of the Federal Blood Product Advisory Committee (BPAC) and FDA officials that the US blood companies want a 3 month deferral in the implementation of the Hepatitis B Core Antibody testing of donors. This request for a deferral is a deliberate delaying tactic agreed upon by all the blood companies.
Source: Class Action Complaint (2004) Case No. C032572 PJH Page 33
Type: Request for deferral
Location: USA
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1983, end of - US Blood Bank
By the end of 1983, only one blood bank in the United States has implemented surrogate testing for AIDS.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 762.
Type: Surrogate testing implemented
Location: USA
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1984, January - Alpha product withdrawal
Alpha recalls its factor concentrates in January 1984. The National Hemophilia Foundation again reaffirm its recommendation that patients continue using concentrates or cryoprecipitate as prescribed by their physicians.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 770.
Type: Product withdrawal
Location: USA
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1984, January - New England Journal of Medicine
A summary is published in the US of 18 cases of AIDS, the only risk factors involved are the receipt of blood components in the 5 years before the onset of the illness.
Source: Krever Commission Report (1997), Vol 3, Part IV, International Milestones: HIV and AIDS 1981-8.
Type: Published Summary (NEJM)
Location: USA
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1984, January - Cutter - License / Pasteurization Process
Cutter receives US license to distribute factor concentrates subjected to a liquid pasteurisation process involving heating at 60C for ten hours.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 755.
Type: US License Pasteurization
Location: USA
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1984, January - Armour - Heat-treatment Process Receives Approval from the FDA
Armour is licensed by the Food and Drug Administration in January 1984 for a dry heat process at 60C for thirty hours.

Note: We have to question the speed at which the heat-treatment process was implemented by Armour. According to the Institute of Medicine Committee report, Hyland, Cutter, Alpha, and Armour claimed to have begun processing and distributing heat-treated factor concentrates immediately after receiving their licences, but none had converted production to heat-treated factor concentrates exclusively. (Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 755, paragraph 2, last 4 lines.)

Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 755.
Type: US License
Location: USA
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1984, January - Annals Internal Medicine - AIDS Reported in the Spouse of a Hemophiliac
There is a report of AIDS in the spouse of a hemophiliac.
Source: Krever Commission Report (1997), Vol 3, Part IV, International Milestones: HIV and AIDS 1981-8.
Type: Report - Spouses
Location: USA
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1984, January - Ex Minister for Health & Community Care - Final Collections of Blood from Prisons
The following quotations are taken from correspondence, dated 6th March 2005 from Andy Kerr MSP, the then Minister for Health & Community Care in reply to Fergus Ewing MSP, who had written to him asking numerous questions, some of which concerned the collection of blood from prisons and borstal institutions:

  • Question: "When and why did it end and what were the circumstances?"
  • Answer: "The last collections in penal institutions were in January 1984 in prisons and in March 1984 in Young Offender Institutions. This followed comments made by the Medicines Inspectorate as well as discussions by the Transfusion Directors."

Note: What he fails to mention in the above is that the Medicines Inspectors commented adversely on the collection of prison blood as far back as 1982. These concerns were then reiterated after further SNBTS inspections, also stating the reasons as to why it was not a good idea. The problem was mentioned again in BBC's Frontline Scotland: "Blood and Tears" in June 2005 when a certain Professor, working for the Scottish National Blood Transfusion Service, was asked if it was a good idea to take blood from prisoners, and he circumnavigated the issue by repeating to Eleanor Bradford that they "phased it out". It should be noted that this 'phasing out' rather astonishingly took 2 years to do.

He also fails to mention that the Home Office was warned of the dangers of AIDS in prisons in December 1983 and again in January 1984 by the Assistant Secretary for the Prison Officers Association - we know this from another document released under FOI.

Background: According to documentation released under FOI, it appears that discontinuing the collection of blood from prisons was going to cause considerable problems for the English and Welsh Health Authorities; as they would not be able to meet their annual blood quotas. (Source: FOI document).
It seems, therefore, that collecting blood from prisons was not just to help the prisoners feel good, the Authorities needed the blood for the repeated attempts at achieving the much-promised self-sufficiency.

Source: Correspondence to Fergus Ewing MSP from Andy Kerr MSP, the then Minister for Health & Community Care. Dated 6th March 2005.
Additional Source: BBC Frontline Scotland - Blood and Tears (2005)
Type: Letter, also BBC Frontline Scotland (June 2005)
Location: Scotland
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1984, 4 January - CSM Sub-Committee on Biological Products / Alpha
The CSM Sub-Committee on Biological Products declines a Product Licence to Alpha Therapeutic Corporation for Bulk Cryoprecipitate (PL 4447/0004 ANTIHAEMOPHILIC FACTOR HUMAN WET-PASTE BULK CRYOPRECIPITATE).

Alpha Therapeutic fails to present adequate product information and are unable to confirm that the bulk cryoprecipitate would be prepared only from human source plasma derived from Alpha's own licensed plasmapheresis centres. They fail to provide satisfactory evidence that the product is at least equivalent in quality to Alpha's US Licensed factor VIII products.

Source: Minutes of the Committee on the Safety of Medicines - Sub-Committee on Biological Products. Appendix F. 4 January 1984.
http://www.taintedblood.info/files/CSM_4_January_1984.pdf
Type: Product Licence Refusal
Location: UK
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1984, 1 February - Red Cross - Call-Back
The US Red Cross introduces a less expensive screening measure on a national scale named "Call-back"; whereby persons who are concerned about the blood they have just donated can call the blood centre and request that their blood not be used for transfusion.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 751
Type: Development Call-back
Location: USA
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1984, February - Cutter
Cutter is licensed for a dry heat treatment at 68C for seventy-two hours.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 755.
Type: US License
Location: USA
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1984, February - Alpha - Wet Heat Treatment Process
Alpha receives approval in February 1984 for factor concentrates subjected to a wet heat treatment process at 60C for twenty hours.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 755.
Type: US License
Location: USA
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1984, 2 February - Cryoprecipitate Could be Produced in Emergencies
In the minutes of a Meeting of the Directors of the SNBTS and Haemophilia Directors on 2nd February 1984, there was a discussion about the production of cryoprecipitate:

"(ii) Members discussed the suggestion that the production of cryoprecipitate could now be reduced. Dr Ludlam said that cryoprecipitate was preferred in the treatment of children at present, because of the new danger of AIDS. Dr Hann concurred..."
"...A policy seemed to be emerging however to use less cryo for haemophilia A patients."
"...It was agreed that a certain minimal amount of cryo was required and Dr Cash pointed out that TDs (Transfusion Directors) could produce it in emergencies."

Note: We have to ask what would constitute "an emergency"? Perhaps the fact that by this time, February 1984, we were several years into the AIDS crisis. The DHSS knew all too well that as much as 50% of the Factor VIII requirements of the United Kingdom were being imported as large-pool commercial concentrates, mostly from the USA. There had been numerous warnings (from the CDSC to the 1983 FDA regulations) yet, the DH and HCDO were still conducting trials on PUPs or as the physicians liked to call them 'virgin haemophiliacs'. This was after January 1983, when Desforges published an article in the NEJM on Hemophiliacs and AIDS, recommending that cryoprecipitate rather than concentrate be used, and in August 1983, the first UK haemophiliac had already died of AIDS from US Factor VIII.

So much for the emergency.

Source: Minutes of Meeting of the Directors of the SNBTS and Haemophilia Directors, 2nd February 1984
http://www.penroseinquiry.org.uk/finalreport/pdf/SNB0015252.PDF
Type: Penrose Evidence File
Location: UK; Scotland
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1984, 9 February - Hepatitis Considered a Well-Recognised Side-Effect
In the Draft Minutes of a Meeting on the Infectious Hazards of Blood Products, at NIBSC in February 1984, we learn that those present knew that NANB-hepatitis had been shown to cause 100% infectivity from first exposure to pooled concentrate:

Dr Thomas (NIBSC): "The undoubted therapeutic benefit of Factor VIII concentrates was clouded by a well recognised side-effect, namely hepatitis, and also, more recently, AIDS. It has been shown that the first exposure to concentrate, from whatever source, is associated with a hundred per cent infectivity with non-A, non-B hepatitis."

Note: We are dismayed to read that they dared to consider hepatitis merely a well-recognised side-effect, and to include AIDS in the same context is deplorable. The minutes state that NIBSC was the Institute that gave 'scientific advice to the Licensing Authority and the Committee on the Safety of Medicines'. So this cannot be excused.

Source: Meeting on the Infectious Hazards of Blood Products, NIBSC. (Draft Minutes)
http://www.penroseinquiry.org.uk/finalreport/pdf/SNB0048628.PDF
Type: Penrose Evidence File
Location: UK
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1984, 17 February - SNBTS / NIBSC - Clinical Trials in PUPs - Virgin Haemophiliacs
In a letter of February 1984, from the Scottish National Blood Transfusion Service to the Department of Haematology in Cardiff, we learn of plans for limited clinical studies in haemophiliacs to be held in September 1984, where the author of the letter, Dr John D. Cash, hopes to have sufficient wet heat-treated Factor VIII made available. Note the awful wording in the following:

Dr Cash: "We are particularly keen to see part of this product is put into "virgin haemophiliacs" and would much appreciate the assistance of the U.K. Haemophilia Centre Director's Working Party on Hepatitis."

Note: This letter makes very upsetting reading. At the time this letter was written, February 1984, they were several years into the AIDS crisis. There had been numerous warnings (from the CDSC to the 1983 FDA regulations) yet, we still find trials being conducted on PUPs or as this letter so horrifyingly words it 'virgin haemophiliacs'.

These Doctors knew that there was no cure for AIDS.

Source: http://www.taintedblood.info/tlfiles/Scottish National Blood Transfusion Service 17 Feb 1984.pdf
Additional Source (with name of author visible):
http://www.slowlyslowlycatchymonkey.com/Virgin_Haemophiliacs_Dr_Cash_Prof_Bloom_Feb_1984.pdf
Type: Recovered Document - Scottish National Blood Transfusion Service. Letter dated 17th February 1984
Location: Scotland
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1984, 28 February - CBLA - Detailed Progress in Genetic Engineering of Factor IX
By February 1984, detailed progress had been made with Factor IX and reference is made to the six stages of investigation which need to be passed through for the preparation of genetically engineered blood products. The stages are as follows:
  • Obtaining a clone
  • Development of the clone
  • Fermentation of the clone material
  • Purification of protein
  • Toxicity trials
  • Clinical trials
"It was noted that three groups from the USA had already completed the second stage of developing a clone for Factor IX. [Deleted Name] reported however that no significant progress had been made on Factor VIII, and he outlined the difficulties for its cloning."

"It was noted however that the Genetics Institute, Boston, USA, had reached the stage of obtaining a clone for Factor VIII."

Note: The future role of BPL with regard to genetically engineered products was questioned and the view was expressed that in the long term, the Laboratory would not purely be involved in human products, but rather in the late 1980's or early 1990's it would have the potential for downstream purification of cloned material.

Source: http://www.taintedblood.info/tlfiles/CBLA Research and Development 28 February 1984.pdf
Type: Recovered Document - Central Blood Laboratories Authority - Minutes of 3rd Meeting of the Central Committee for Research and Development in Blood Transfusion. Dated 28th February 1984.
Location: UK
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1984, March - US Plasma Industry Study Group on Hepatitis B Core Testing
The US Plasma Industry Study Group on hepatitis B core testing reviews the Greater New York Blood Program's experience with confidential unit exclusion and recommends that pilot programs be developed in US plasma collection centres.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 751.
Type: Pilot programs
Location: USA
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1984, March - Possible Date for the Cessation of Blood Collection from UK Prisons
The collection of blood from prisons and borstal institutions in the United Kingdom continues right up until March 1984, despite repeated warnings that the practice is unsafe. WHY did the Authorities persist with taking blood from prisoners for so long?

Here is a list of just some of the ignored warnings regarding UK prison blood:

  • In 1958, there was an early warning from a respected international source. Dr. J. Garrott Allen discovered what he referred to as the "prison effect" after conducting a survey in the Chicago area.
  • In 1980 we know that blood from Scottish prisoners was used in NHS transfusions despite serious concerns being raised.
  • Then in 1983, the Medicines Inspector commented adversely on the practice of collecting blood from prisons and borstal institutions.
  • By July 1983, the Medicines Division's Inspection Action Group had expressed serious concerns about the collection and use of blood from borstal institutions and prisons.

Note: We are appalled to learn that the practice of blood collection from UK prisons and borstal institutions continued right up until March 1984 - well after prisoners were considered to be high-risk donors.

Source: Definitive Source Pending. (See Find Related Entries link below for additional sources).
Type: Possible Date for the Cessation of the Practice of Blood Collection from UK Prisons & Borstal Institutions. Circa March 1984.
Location: UK
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1984, 7 March - CSM Sub-Committee on Biological Products / Hoechst Licence
The CSM Sub-Committee on Biological Products grants a Product Licence to Hoechst UK Limited for Factor VIII H.S. (PL 0086/0100 ANTIHAEMOPHILIC).

Certain conditions are imposed by the Sub-Committee in the granting of the licence. The product particulars are to be amended to include a statement that the material is heat-treated, that no claims are made regarding the transmission of HBV and NANBH and that there are to be no claims with reference to AIDS other than in the form of a warning that the blood product may contain the syndrome.

Source: Minutes of the Committee on the Safety of Medicines - Sub-Committee on Biological Products. Appendix B. 7 March 1984.
http://www.taintedblood.info/files/CSM_7_March_1984.pdf
Type: Product Licence Granted
Location: UK
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1984, 13 March - Task Force on Hepatitis B Testing (FDA / Plasma Centers / Voluntary Sector)
An interim summary statement is released by the chairman, Dr Rodell, who states that although the majority of task force members are not in favour of testing, they recognized the need to adopt it if it is to be performed by other manufacturers. The study group held that a positive test for anti-core is not necessarily indicative of AIDS, but is simply a possible means of identifying persons in high-risk groups.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 762.
Type: Statement following Meeting on 6th March 1984.
Location: USA
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1984, 29 March - HCDO
The memorandum of the HCDO on September 1983 regarding the types of heat-treated factor VIII concentrate that would be available for clinical trials in 1983-4, was revised and circulated to directors. At this early stage, the chairman of the Haemophilia Centre Directors' Organisation reported that there were 8 different (heat-treated) products in preparation or available for trial.

Only Hemofil-T, manufactured by Travenol Laboratories Inc, had completed it's clinical trials.

Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 33, page 931, paragraph 3.
Type: Revised memorandum
Location: UK
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1984, 29 March - Oxford Haemophilia Centre - Trials Update - Risk of AIDS Transmission
In a memorandum from Oxford Haemophilia Centre, to all U.K. Haemophilia Centre Directors, an update of trials of 'hepatitis-reduced' Factor VIII is given.

The memorandum states that the products currently available are:-

  • Heated products from Armour, Cutter, Travenol and Alpha Therapeutics
  • NHS Factor VIII prepared from a specially selected donor panel
  • Heated NHS Factor VIII (one brand from PFC Edinburgh, one from Elstree available later in 1984)
  • A heated preparation from Behringwerke, Germany
The memorandum also states, rather importantly, that:

"All products except those derived from NHS factor VIII are made from plasma imported from the U.S.A., and, therefore, they carry a putative risk of transmission of AIDS." (Final paragraph of page 1)

Note: They conducted these trials whilst knowing that there was no cure for AIDS.

Source: http://www.taintedblood.info/tlfiles/Oxford Haemophilia Centre Hepatitis Reduced 29 March 1984.pdf
Type: Recovered Document - Oxford Haemophilia Centre Trials of Hepatitis-Reduced FVIII. Dated 29th March 1984.
Location: UK
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1984, April - Armour, Cutter, Alpha, Baxter
The US Blood Companies finally introduce the Hepatitis B Core Antibody (HBc) test. This is late since the HBc test was reported to be an effective surrogate test for both AIDS transmission and Non-A non-B Hepatitis carriers by 1982.
Source: Class Action Complaint (2004) Case No. C032572 PJH Page 39
Type: Test introduction
Location: USA
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1984, April - National Institutes of Health (USA)
The National Institutes of Health develops and patents a prototype screening test for HIV antibodies and, by May, has solicited applications from various US manufacturers interested in the commercial use of the tests.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 765.
Type: Prototype Screen Test / NIH
Location: USA
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1984, April - National Hemophilia Foundation / CDC
The National Hemophilia Foundation learns that the CDC has received reports of 9 new cases of AIDS among US hemophiliacs in the first quarter of 1984. The National Hemophilia Foundation again fails to recommend any change in treatment.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 771.
Type: CDC Statistics
Location: USA
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1984, April - Bayer - Secures Patent for Pasteurisation Process
Bayer publishes a patented method for the pasteurization of Factor VIII.
Source: Hepatitis C and Heat Treatment Of Blood Products For Haemophiliacs In The Mid 1980s. Scottish Executive – Health Department. October 2000, Annex A, Page 3.
http://www.scotland.gov.uk/library3/health/hepatitis_c.pdf
Type: Patent Publishing
Location: USA
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1984, 23 April - Secretary of Health and Human Services
The Secretary of Health and Human Services announces that the AIDS virus has been identified and that a blood test for AIDS would be widely available within 6 months.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 763.
Type: Announcement
Location: USA
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1984, 23 April - Robert C. Gallo, MD
Gallo announces isolation of Human Immunodeficiency Virus (HIV).
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Announcement
Location: USA
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1984, May - 'Science' Gallo
Gallo publishes a study showing that HTLV-III may cause AIDS.
Source: Krever Commission Report (1997), Vol 3, Part IV, International Milestones: HIV and AIDS 1981-8.
Type: Announcement
Location: USA
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1984, May - HT1 (Heated) Factor VIII - Issued on Trial Basis
Trial issues begin of HT1 factor VIII (heated at 60C for 72 hours).
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Trials
Location: UK
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1984, May - American Association of Blood Banks - New AIDS Test - Patent Pending
In an article in the American Association of Blood Banks in May 1984, under the heading "Probable Cause of AIDS Identified", the following is stated:

Margaret M. Heckler: "We now have a blood test for AIDS which we hope can be widely available within six months" (Paragraph 1)

Heckler: "With the Blood test, we can now identify AIDS victims with essentially 100 per cent certainty." (paragraph 2)

Note: Rather astonishingly, the article also mentions that it was thought by Federal Officials that an AIDS vaccine might well be available within 2 to 3 years. (Paragraph 3)

A patent was pending for the AIDS test, and the US government was said to be interested in either making the test or farming-out it's manufacture to industry. (Final paragraph)

Source: http://www.taintedblood.info/tlfiles/American Association of Blood Banks May 1984.pdf
Type: Recovered Document - American Association of Blood Banks, Vol 7/Number 5
Location: USA
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1984, 11 May - Christine A. Lee - Senior Registrar - Gross Understatement of Risk to Haemophiliacs
In a Haemophilia Society 'Haemofact' leaflet, May 1984 Release No. 3, Christine A. Lee, Senior Registrar at the Royal Free Haemophilia Centre, comments rather too conservatively on the occurrence of AIDS in UK haemophiliacs:

"The occurrence of acquired immunodeficiency syndrome (AIDS) in haemophiliac patients has strongly suggested transmission of the disorder by blood products and epidemiological studies have suggested it may be related to a transmissible agent."

"In Great Britain the number of haemophiliacs who have been reported with AIDS remain at 2. Thus the incidence is less than 1 in 1,000 patients at risk."

Note: We are concerned to read that the incidence of AIDS in haemophiliacs was only described at 0.1%. Surely this was a gross misrepresentation of the risk from blood products? Christine A. Lee's comments on the risk suggests a misleading mindset as she seemed to think the total haemophilia community totalled 2,000. This could not possibly have been right - it should've been nearer 5,000. We have to wonder what statistical information this population figure was based on?

Background: The following list of developments detail what we believe Christine A. Lee should have considered before making the statement; (after all, the clues were there as to the real scale of the risk):

  • In January 1983, Desforges published an article in the NEJM on Hemophiliacs and AIDS, recommending that cryoprecipitate rather than concentrate be used.
  • In August 1983, the first UK haemophiliac dies of AIDS from US Factor VIII administered in December 1981.
  • Whilst in October 1983, in the UK, there were only 2 haemophiliac cases of AIDS, in the USA, however, there were 22 patients with N.I.H diagnostic criteria for AIDS and 10 patients had by that time died.
  • In January 1984, a summary was published in the NEJM of 18 US cases of AIDS where blood components were involved.
  • By April 1984, the National Hemophilia Foundation learned that the CDC had received reports of 9 new cases of AIDS among US haemophiliacs.

Note: We would like to point out that only 10 months later, (March 1985), the DHSS Finance Division (FA1), expresses fears that the haemophiliac population (around 5,000) could be very seriously affected indeed, with two-thirds possibly already sero-positive, and 240 haemophiliacs possibly manifesting AIDS within one year, and as many as 1,200 eventually developing AIDS.

Source: http://www.taintedblood.info/tlfiles/Haemofact AIDS Release No 3 11 May 1984.pdf
Type: Haemophilia Society - HAEMOFACT - AIDS - Release No 3 - Dated 11th May 1984
Location: UK
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1984, June - AIDS Transmitted by Blood Products - Clinical State of the Art Established
In June 1984, an editorial accepted that AIDS was transmitted by blood products. Even though only 1/1000 USA haemophiliacs had AIDS around 50% had immune abnormalities (BMJ 1984: 288,1782). This article is a 'key' document in that State of the Scientific Art was formally declared.

Note: Clinical State of the Art was established about here. All efforts should have been made at this stage to secure heat-treated products for haemophilia A and B patients.

Source: British Medical Journal, 1984: 288,1782.
Additional source:
http://www.taintedblood.info/tlfiles/Aids Haemophilia Med 1981_1986 Chronology.PDF
Type: Chronology of AIDS and Haemophilia 1981-1986.
Location: UK / USA
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1984, 4 July - CSM Sub-Committee on Biological Products - Armour
The CSM Sub-Committee on Biological Products declines a Product Licence to Armour Pharmaceutical for Factor VIII (PL 0231/0072 HEAT TREATED HIGH POTENCY FACTORATE ANTIHAEMOPHILIC FACTOR).

Armour fails to present adequate evidence of safety and efficacy in clinical use, and fails to present adequate biological evidence of the effect of heat-treatment on infectivity and on the transmission of hepatitis.

Source: Minutes of the Committee on the Safety of Medicines - Sub-Committee on Biological Products. Appendix C. 4 July 1984.
http://www.taintedblood.info/files/CSM_4_July_1984.pdf
Type: Product Licence Refusal
Location: UK
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1984, 16 July - Dr Rodell - Task force on Hepatitis B testing
Dr Rodell submits the Task Force on Hepatitis B Testing final report on hepatitis B core testing to the FDA. It acknowledges that although there is divided opinion about the appropriateness of such testing, the majority of members are not in favour of it.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 763.
Type: Task Force Final Report
Location: USA
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1984, 27 July - DHSS - Diagnostic Test for Antibodies to HTLV-III - being used prior to 27 July 84
In a letter from the DHSS, it is clear that there is a diagnostic test available for antibodies to HTLV-III and that it's being used prior to 27 July 1984:

"Since my minute of 6 July there have been further developments regarding the radio immunoassay for antibody to HTLV III. Some 2,000 tests have been carried out on AIDS patients..."

___________

Note: It is clear that in order for some 2,000 tests to have been carried out on Aids patients by the time the DHSS minute was written on 6th July 1984, the early diagnostic tests must have been available some months prior to this time...

Background: We know that by the Summer of 1984, the PHLS had access to 'in house' anti-HTLV-3 assays which were being developed in UK research laboratories.

Source: DHSS Letter, Hannibal House. Dated 27 July 1984:
http://www.taintedblood.info/tlfiles/AIDS - Development of Diagnostic Test HTLV III July 1984.pdf
Type: Recovered Document - DHSS Letter, Hannibal House. 27 July 1984
Location: UK
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1984, summer - PHLS - In House Anti-HTLV-3 Assays Being Developed in UK Research Laboratories
In a PHLS flowchart on the introduction of the early Anti-HTLV3 / LAV assay, we learn that in the Summer of 1984, UK research laboratories were already developing early AIDS antibody tests:

Production, Evaluation & Introduction of Screening Tests

Summer 1984: "In house" anti-HTLV3/LAV assays developed in a few foreign and UK research laboratories. PHLS Virus Reference Laboratory (VRL) and the Middlesex Hospital available as primary testing centres.

NOTE: The discovery of this new information within the latest DOH FOI release (20.05.09) is very important because we are now learning just how early on in time the diagnostic assay for Aids antibodies was available - but only to certain bodies, such as the PHLS. For the actual screening of the UK's blood donors, we had to wait another year and 3 months - i.e. until 14th October 1985, when the UK implemented Donor Screening. This is very disturbing.

Source: http://taintedblood.info/files/1243385043Introduction_of_Anti-HTLV-3_Assay.pdf
Type: DOH FOI Document - PHLS Flowchart for the Introduction of the Anti-HTLV-III / LAV Assay. 4th June 1985
Location: UK
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1984, 31 July - DHSS - Wider Availability of a Diagnostic Test For HTLV-III
In a DHSS letter of 31 July 1984, reference is made to the formation of a note, the contents of which reveal the intention to 'forestall the pressure' for the wider availability of a diagnostic test for HTLV-III - due to the experimental nature of the arrangements for the development of the test at an RTC:

"The note might also need to deal with the question of publicising the research in such a way as both to take credit for Government support for development of the test and to make it clear that the arrangements at the North West London RTC were experimental, ie to forestall pressure for the immediate availability of the test throughout the blood transfusion service and more generally through GPs and STD clinics." (Paragraph 3)

Note: It is not altogether clear what is being implied by this letter. However, it can be said that in a DHSS letter dated 4 days early (27 July 1984), that the radio immunoassay for antibody to HTLV III had already been used to test some 2,000 AIDS patients. (see additional source link below).

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1984, Summer - CDC Tests
Tests are carried out at the CDC which show that non-heat treated intermediate purity factor products are known to be contaminated with HIV. The tests demonstrate that 70% of type A severe hemophiliacs and 40% of type B hemophiliacs are HIV positive.
Source: Class Action Complaint (2004) Case No. C032572 PJH Page 35
Type: Development - Test Results
Location: USA
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1984, August - CBLA - Batch of Factor VIII in Scotland with High Attack Rate of HTLV-III
In the minutes for the fourth meeting of the Central Committee for Research and Development in Blood Transfusion:

"Dr [Deleted Name] referred to a batch of Factor VIII in Scotland, fractionated in November, 1983, which was discovered to contain anti-HTLV3 in August, 1984. It was noted that a virus attack rate on this product could be as high as 80%. The remainder of the product had been withdrawn, but the incident served to highlight the difficulties that lay ahead in this context." (Page 2, point 8.2, paragraph 3)

Under the heading "Trials of SNBTS Heat Treated Factor VIII" the following is stated:

"[Deleted Name] confirmed that he would be able to test the Scottish material whilst continuing to test that supplied by the Director BPL. [Deleted name] considered that some assistance towards such trials could be forthcoming from the S.W. Region..." (Page 3, point 9/84, paragraph 1)

"It was noted that there was not sufficient suitable patients in Scotland to test its heat treated Factor VIII whilst [Deleted Name] explained that the trials might have to be re-thought in view of the HTLV3 virus" (Page 3, point 9/84, final paragraph.)

Source: http://www.taintedblood.info/tlfiles/Central Blood Laboratories Authority 9 Nov 1984.pdf
Type: Recovered Document - CBLA Minutes for the fourth meeting of the Central Committee for Research and
Development in Blood Transfusion. 9 November 1984
Location: Scotland
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1984, 13 August - NBTS - Pursuit of United Kingdom-Owned HTLV-III Antibody Test
In an NBTS Advisory Committee paper of 13 August, 1984, the need for a UK virus isolate is discussed:

"You will be aware of the recent development by [deleted name] of a radioimmunoassay for HTLV III antibody and the findings that the limited use of this test has revealed." (Page 1, point 2.)

"...it is hoped to extend the screening test to at least two other Regional Transfusion Centres. This, of course, depends on our ability to scale-up productions of reagents for the test using either the virus isolate from Dr Gallo's laboratory or a UK isolate (yet to be achieved)." (Page 1, point 2, lines 7-11)

"The information collected from the use of a screening test in three centres will provide a basis on which to base policy decisions about extending the test more widely to the whole of the NBTS. We would therefore be in a strong position to make decisions about the need to buy from one of the five US pharmaceutical companies who have licensed to produce a screening test and are likely to wish to start marketing these tests in the UK in the next few months." (Page 1, point 2, from line 8.)

Note: Five US pharmaceuticals were poised to start marketing HTLV tests in late 1984. Yet, there seemed to be some reluctance in the NBTS to buy in the test from abroad; perhaps due to cost or the availability of the isolates. Nevertheless, there appeared to be a 'race' on for Britain to find it's own test - an action which may have served to delay the wider release of these urgently needed tests.

Source: http://www.taintedblood.info/tlfiles/Proposed Working Group of the Advisory Committee NBTS.pdf
Type: Recovered FOI Document - Proposed Working Group of the Advisory Committee on the National Blood Transfusion Services - Consequences to the NBTS of Screening for HTLV-III. 13th August 1984
Location: UK
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1984, 20 August - The Institute of Cancer Research - Sensitive and Specific HTLV III Antibody Test
In a draft question and answer briefing for Officials on a proposed article in the Lancet regarding AIDS, the following is stated:

"Officials have been aware for some weeks that research workers have developed a test which detects antibody in the serum of AIDS patients and others to HTLV III and LAV viruses both of which are believed to be agents involved in the development of AIDS."

"The test is based on isolates of HTLV III obtained from [Deleted name, probably Dr Gallo's?] laboratory at the National Institutes of Health, Bethesda, USA who made them available to research workers in the UK on the basis of exchange of material resorted to by such people. The test appears to be sensitive and specific and is possibly more reliable than other tests currently available in the USA and elsewhere." (Pg 2)

Source: http://www.taintedblood.info/tlfiles/Publication of a Paper in the Lancet.pdf
Type: Recovered Document - Publication of a Paper in the Lancet on the Use of a Screening Test for AIDS. 20 August 1984
Location: UK
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1984, September - The Lancet - Dr Jay A. Levy, et al.
Confirmation that HIV is susceptible to heat is first reported in The Lancet by Dr Jay A. Levy and colleagues in September 1984. Dr Levy added mouse retroviruses to human plasma and found that freeze-dried material had to be heated at 68C for several hours before substantial quantities of the infectious virus were inactivated.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 755.
Type: Heat treatment research
Location: USA
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1984, September - CDC / Hemophilia Treating Physicians
At a conference for treating physicians and CDC officials, there is agreement that physicians treating hemophiliacs should consider changing to heat-treated factor concentrates, even though there is as yet insufficient proof that heat treatment is effective in inactivating the AIDS virus.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 756.
Type: Conference
Location: USA
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1984, 1 September - Chiengsong Popov et al
Chiengsong Popov and others in the Lancet announce reliable tests for HIV:

34% of tested English haemophiliacs have virus.

Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: The Lancet
Location: UK
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1984, 10 September - Reports on Factor VIII Batches Received by Cardiff & Bristol AIDS Cases
In a letter entitled 'Current Situation Regarding AIDS', the Public Health Laboratory presents a table and accompanying histograms based upon reports received from Haemophilia Centres about the patients who received the same batches of blood products as the Cardiff and Bristol AIDS cases.

The batch numbers in question are detailed in the following table:

109790098004180049800017900679S1010112078T40405
12378R5910R2709R97906R6511 09M07980110477P1A12710M6375

Note: This shows that Haemophilia Centres had a good enough system of record-keeping so as to be able to identify and trace which patients had received which batch. We have to ask whether patients were warned so that they could inform and protect their partners/spouses?

Source: http://www.taintedblood.info/tlfiles/Public Health Laboratory Batches 10 September 1984.pdf
Type: Public Health Laboratory Table and Histograms. Dated 10th September 1984
Location: UK
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1984, 29 September - Dr Levy, JA
Dr Levy publishes in the Lancet a definitive paper showing that heat-treatment eliminates HIV.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: The Lancet
Location: UK
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1984, October - CDC Report - Cutter
The CDC reports that 74 percent of US hemophiliacs who used unheated product are HIV positive. The same CDC report indicates that a study done with Cutter showed that heat-treatment rendered HIV "undetectable" in factor concentrate.
Source: Class Action COMPLAINT (2004) Case No. C032572 PJH, page 22.
Type: Report / Study
Location: USA
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1984, October - CDC Report - MMWR
The CDC reports that there are 52 cases of AIDS in Hemophiliacs.
Source: Krever Commission Report (1997), Vol 3, Part IV, International Milestones: HIV and AIDS 1981-8.
Type: CDC Statistics
Location: USA
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1984, December - UKHCDO - AIDS Advisory Document - NANBH
In December 1984, the UKHCDO issues an "AIDS Advisory Document" which mentions that dry heat treatment of Factor VIII at 68C inactivates the AIDS virus, but only notes in passing that it is unlikely that the process will completely inactivate Non A Non B Hepatitis.
Source: Hepatitis C and Heat Treatment Of Blood Products For Haemophiliacs In The Mid 1980s. Scottish Executive Health Department. October 2000, Page 9, Point 33.
http://www.scotland.gov.uk/library3/health/hepatitis_c.pdf
Type: Advisory Document
Location: UK
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1984, 4 October - Wessex RTC - Recall of Contaminated BPL Factor VIII - Batch HL3186
In a letter from Wessex Regional Transfusion Centre (WRTC) to the Head of Quality Control, BPL, we learn of a male blood donor who has been admitted to "a Bournemouth hospital; the clinical diagnosis is almost certainly AIDS."

The letter outlines the previous donations of the male donor, who had donated blood in November 1982 in Leeds, and three more times at Bournemouth in September 1983, March 1984 and September 1984.

"There is also the possibility of a donation before November 1982 in this region, which we are attempting to trace." It appears that the September 1983 and March 1984 donations were already used.

Note: We cannot help but wonder why there aren't any recommendations here to alert patients?

In another WRTC letter from the Deputy Medical Director to various Consultant Haematologists in the South, including the Lord Mayor Treloar school, the author explains the reason for the recall. The Deputy Medical Director makes the following unethical request of the centre directors:

"In order to prevent undue worry to your patients, may I ask for your discretion here and, for the time being at least, to keep this news to yourself."

Note: We are perturbed to read that Doctors are specifically told not to tell patients, thereby putting partners/spouses at risk.

Source: Wessex Regional Transfusion Centre Letters Dated 4th October 1984
http://www.taintedblood.info/tlfiles/Wessex RTC Letters ref Batch HL3186 04 Oct 1984.pdf
Type: Letters from Wessex Regional Transfusion Centre to Head of Quality Control BPL. Dated 4th October 1984
Location: UK
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1984, October - CDC - Heat Treatment
The CDC publishes the results of research which suggests that the virus identified by Gallo could be inactivated by the use of heat in dry Factor VIII concentrate.
Source: Report of the Tribunal of Inquiry, Lindsay Final (2002), page 60:
http://www.taintedblood.info/tlfiles/Lindsay_Final.pdf
Type: Development - Research
Location: USA
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1984, 5 October - DHSS - HS1 - AIDS Contamination of Factor VIII Concentrate
In handwritten briefing notes entitled 'AIDS Contamination of Factor VIII Concentrate' from DHSS HS1 division, we learn that there were substantially more vials of contaminated Factor VIII made from the suspect donation of March 1984.

In fact, a total of 885 units were supplied as follows:

  • 485 vials were sent to Wessex RBTS on 10th August 1984
  • 400 vials were supplied to Cardiff RBTS on 17th August 1984

The notes go on to say that: "They were passed down to Haemophilia Centres for supply to patients. Thus it is known by the Centres precisely which patients received supplies from this batch. BPL are recalling the batch and this is under control."

Note: It is interesting to observe that the title of these briefing notes makes use of the term 'AIDS' when the diagnosis of the donor wasn't officially confirmed until eleven days later (on 16th October 1984).

Source: http://www.taintedblood.info/tlfiles/DHSS HS1 AIDS Contamination of Factor VIII 5 October 1984.pdf
Type: DHSS HS1 Handwritten Briefing Notes Reference - Contaminated Factor VIII - Batch HL3186 - DHSS HS1 AIDS Contamination of Factor VIII. Dated 5th October 1984
Location: UK
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1984, 8 October - Wessex RTC - 390 Contaminated Vials Unreturned - FVIII Batch HL3186
In a letter from the Wessex Regional Transfusion Centre (WRTC) to BPL, the details of a contaminated Factor VIII batch HL3186 are discussed along with how many vials were unreturned. Of the 485 that had been sent out, only 95 were returned.

  • This clearly leaves 390 contaminated vials unaccounted for.

Note: We are extremely concerned to read that 167 vials of this contaminated batch were used up at the Lord Mayor Treloar College, Alton - a well-known specialist school, catering for boys with haemophilia. Only 33 vials out of a total of 200 were returned from the Treloar school.

Note: We believe that there was a good chance that the WRTC were aware that most, if not all, of the 390 unreturned vials had already been transfused into patients. Presumably these patients could have been easily traced and informed?

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1984, 16 October - Wessex RTC - Contaminated BPL Factor VIII - Batch HL3186
In a letter of 16 October 1984, from WRTC to all Haemophilia Centre Directors in Wessex, we find confirmation that: "the diagnosis of AIDS has now been confirmed." The Deputy Medical Director goes on to say that further contact will be made: "within the next day or so" regarding follow-up of patients, but that: "in the meantime I have been asked to suggest a policy of discrete surveillance be pursued."

Note: It is disgusting to read that despite the donor having a confirmed AIDS diagnosis, the official line of the Deputy Medical Director and the WRTC is still not to inform patients.

Then in a letter from WRTC dated the same day, a Consultant Pathologist is notified at the Royal Naval Hospital, Gosport, Hants. This correspondence is obviously the first the RN Hospital has heard of the contaminated batch - and for some reason 12 days later than anyone else.

In a third letter of 16th October 1984, the WRTC write to the Queen Alexander Hospital, Portsmouth, where we learn of another hospital where this notification is the first they've been told about receiving the contaminated batch.

Note: As with the Naval hospital, why weren't these hospitals informed earlier?

Source: Letters from Wessex Regional Transfusion Centre. Dated 16 October 1984
http://www.taintedblood.info/tlfiles/Wessex RTC Letters Ref Batch HL3186 of 16 Oct 1984.pdf
Type: Letters from Wessex RTC Ref. Contaminated BPL Factor VIII Batch HL3186
Location: UK
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1984, 23 October - PHLS - Dr Craske - Contaminated BPL Batch - HL3186
A letter from the Public Health Laboratory Service (PHLS) in Manchester, details the discovery of a batch of Factor VIII [Batch No. HL3186] that was made from pooled plasma where one of the donors was later confirmed to have antibodies to HTLV-3 (HIV). The letter also confirms that epidemiological follow-up studies are to be carried out on the recipients of that batch.

  • We know that Dr Craske had detailed knowledge about the situation regarding AIDS in the USA, especially since he was tasked with looking into reports of the syndrome in 3 haemophiliacs from the United States in September 1982.
  • Dr Craske even knew about the connection between AIDS and US commercial blood products.
  • We also know that from October 1983, the UK Haemophilia Centre Directors had considerable, documented awareness of the risk of AIDS to the spouses of haemophiliac patients.
With this in mind, we strongly believe that the physicians involved in this BPL product recall were remarkably casual in their approach to dealing with it. The delays incurred in telling patients meant that their wives and partners were put at risk. We would suggest that this was because of directives from Dr Craske.

Source: Dr Craske. Public Health Laboratory Service. Letter dated 23, October 1984.
http://www.taintedblood.info/files/Public%20Health%20Laboratory%20Letter.pdf
Type: Letter
Location: UK
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1984, 23 October - Dr Craske - PHLS - Whether or Not to Inform Patients of Exposure to HTLV-III
In a PHLS letter of October 1984, two alternative strategies for the follow-up of haemophiliac patients who have received an HTLV-III implicated batch are deliberated. Surprisingly, the option of NOT INFORMING patients is considered:

Dr. Craske: "An alternative strategy would be not to tell the patient of the risks involved but to observe him at regular clinical review four monthly, to collect serum specimens for HTLV-3 antibody examination and send them to me at Manchester." (page 3, section ii)

"There is evidence that HTLV-3 infection can be transmitted by sexual contact. Therefore some sexual partners of recipients of factor VIII contaminated with HTLV-3 may be at risk." (page 2, point 5)

Investigation of spouses:

"This will be at the discretion of the Haemophilia Centre Director, and will depend upon whether it is decided to inform the index patient of the possibility that the batch of factor VIII was contaminated with HTLV-3 virus." (page 3, section d)

Note: Even after Dr Craske knew that HTLV-III infection could be transmitted to spouses by sexual contact, he was still deliberating the option of not informing patients. In an Appendix on page 5, Dr Craske does eventually state that the option of informing the patient is "the only one tenable on moral and ethical grounds." However, this conclusion should not even have required discussion, never mind arriving at it almost as an afterthought.

Source: http://www.taintedblood.info/tlfiles/PHLS Letter 23 October 1984.pdf
Type: Recovered Document - PHLS Letter from Dr Craske. Dated 23 October 1984.
Location: UK
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1984, late October - Alpha, Hyland, Cutter
Alpha, Cutter, and Hyland start to distribute heat-treated factor IX concentrate in late October 1984.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 756.
Type: Development
Location: USA
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1984, November - Cutter Meeting - Excess Non-Heated Inventory
In the minutes of a CUTTER meeting, they state that "there is excess non-heated inventory," and that the company plan to "review international markets again to determine if more of this product can be sold."
Source: First Amended CLASS ACTION COMPLAINT (2004) Case No. C032572 PJH. Page 22
Type: Minutes
Location: USA
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1984, 9 November - CBLA - Significant Progress in the Cloning of Factor VIII
In the minutes of the CBLA in November 1984, there is mention of progress in the cloning of factor VIII:

"The Chairman confirmed that following [Deleted Names] attendance at the Committee's last meeting, he and the Director of BPL had recently visited the USA to discuss possible research and development collaboration for the preparation of Factor VIII through genetic engineering". (Page 1, point 8.1)

"Two firms, namely [Company Names Deleted], had now made significant progress in cloning Factor VIII" (Page 1, point 8.1, line 5.)

Source: http://www.taintedblood.info/tlfiles/Central Blood Laboratories Authority 9 Nov 1984.pdf
Type: Recovered Document - CBLA Minutes for the fourth meeting of the Central Committee for Research and Development in Blood Transfusion. 9 November 1984
Location: UK
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1984, 18 November - John Patten - Aids and Blood Products
In a departmental press release to be relayed to TV, radio, and other media outlets, the following is stated on behalf of John Patten, Parliamentary Secretary for Health:

"The Government is already committed to self-sufficiency in blood products by trebling the manufactured output from British donors."

"On 23 March this year Norman Fowler, Secretary of State for Social Services laid the foundation stone for the re-building of the Elstree Blood Products Laboratory - part of the NHS - and increased production should begin in January 1986."

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1984, 19 November - BPL
Blood Products Laboratory (BPL) announces that by April 1985 it will begin heat-treating factor concentrates to 60C for thirty minutes.
Source: The Lord Glenarthur. Letter to Tanner AJ, The Haemophilia Society. 12 December 1984.
Type: Announcement
Location: UK
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1984, 19 November - John Patten - Britain to be Self-sufficient in Blood Products by 1986...
In a DHSS Press Release of 19 November 1984, John Patten, Parliamentary Secretary for Health announces that Britain should be self-sufficient in blood products by late 1986. He also announced that action was being taken on four fronts to combat the spread of Acquired Immune Deficiency Syndrome (AIDS) in this country.

Mr Patten said: "Our multi-million pound development project at the Blood Products Laboratory, Elstree, is on target for completion early in 1986 and this should enable us to become self-sufficient in blood products, such as Factor VIII which is the clotting agent required by haemophiliacs, by the end of that year..."

"...This will mean we no longer have to import factor VIII from abroad."

Note: So what went wrong? ...

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1984, 20 November - DHSS
DHSS announces that NHS heat-treatment will commence from next year.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Announcement
Location: UK
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1984, 20 November - Dr Seale - Attempts for 2 Years to Alert Public Health Officials of AIDS Threat
In an article in The Standard, it states that Dr Seale had been trying to alert public health officials to the implications of the threat of AIDS for nearly two years:

Dr John Seale: "I wrote to both Mrs Thatcher and the Public Health Laboratory Services to suggest blood transfusion policy changes then." (paragraph 4)

Note: This article shows that both Margaret Thatcher and the PHLS were notified circa November 1982 and could reasonably have been expected to know about the threat of AIDS to the Blood Transfusion Service and thus to haemophiliacs.

Source: http://www.taintedblood.info/tlfiles/Decision on AIDS Too Late 20 Nov 1984.pdf
Type: Recovered Document - Article in The Standard, by Alan Massam. 20th November 1984
Location: UK
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1984, 27 November - DHSS Working Party on AIDS
DHSS Working Party on AIDS unanimously recommends donor screening and heat-treatment as soon as possible.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Recommendations
Location: UK
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1984, late - Krever report
Voluntary confidential reports from microbiologists who are working in UK laboratories where HIV tests were carried out voluntarily provide surveillance of HIV infection.
Source: Krever Commission Report (1997) Vol 3, Part IV, Chap 33, page 928.
Type: Statement
Location: UK
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1984, December - BPL
38 UK haemophiliacs receive factor concentrate from a contaminated batch:
A contaminated batch of factor VIII concentrate has to be withdrawn by BPL when it is discovered that one of the donors who has supplied plasma for it has been admitted to hospital with AIDS.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 33, page 932-3.
Type: Batch withdrawal
Location: UK
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1984, December - The Lancet (Editorial) - HIV Sensitive to Heat
An editorial in The Lancet states that HIV is sensitive to heat, and that heat treatment could be rapidly introduced. The editorial concludes that it is "reasonable to switch to heat-treated factor VIII concentrate," and "indefensible" to do otherwise.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 756
Type: Editorial (The Lancet)
Location: UK
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1984, December - National Hemophilia Foundation - Distribution of Heat-treated Factor IX Commences
The National Hemophilia Foundation informs its members that Alpha, Cutter, and Hyland have started to distribute heat-treated factor IX concentrate as of late October 1984.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 756
Type: Statement
Location: USA
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1984, December - FDA
The Food and Drug Administration publishes a recommendation that all US blood banks introduce a screening method of providing donors with an opportunity to withdraw their blood confidentially.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 751
Type: Recommendation published
Location: USA
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1984, 3 December - Institute of Cancer Research - Suggestion of An Independent AIDS Test for UK
In a letter to the DHSS from the Office of Professor R. A. Weiss of the Institute of Cancer Research, it is clear that the advice to Ministers is that the U.K. should probably drop the use of any American reagents and have a local and independent AIDS test:

"I am Just writing to confirm that in view of (a) having a local, independent isolate of the AIDS retrovirus and (b) the requirement in [Deleted Name's] letter for the U.K. to negotiate with American commercial licensees, we should probably drop the use of any American reagents in scaling-up our methods for serological screening and develop our own independently."

Note: This is an example of COST concerns overriding Physicians' urgency to inform patients of their status. The emphasis, here, is on the cost of the commercial isolates for the AIDS test, which is overriding the importance of CLINICAL NEED.

Source: http://www.taintedblood.info/tlfiles/Institute of Cancer Research 3 December 1984.pdf
Type: Recovered Document - Letter to the DHSS from Institute of Cancer Research. 3rd December 1984
Location: UK
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1984, 10 December - Haemophilia Centre Directors Meeting at BPL - Product of Choice is Heated
In a meeting of the HCD at BPL it is established that Heated product is preferred for all new patients, (subject to availability); otherwise it is to be preferentially offered for the treatment of HIV- patients.

BPL confirms all factor VIII will be heated by April 1985. Heating is expected to carry a 15-20% yield penalty.

Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Meeting
Location: UK
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1984, 10 December - Dr R S Lane (BPL) - Spiking of Factor VIII with Active Antigen
In the notes of the Haemophilia Reference Centre Directors Meeting of 10th December 1984, we read that factor VIII was spiked with antigen prior to heating:

"Dr Lane remarked that in order to determine the effectiveness of the heat-treatment, spiking of Factor VIII with antigen was required prior to heating. The present methods used by the NHS and commercial companies may still leave an active antigen. BPL would therefore be looking for follow-up studies during 1985 with Haemophilia Centre Support". (page 8, paragraph 4)

Note: We have seen documents that state that physicians felt it had never been appropriate to test the final factor VIII concentrate in an attempt to demonstrate its safety from viral infection - because the available techniques were not adequately sensitive to identify infectivity, i.e. concentrates which test negative on virological investigation can still transmit viral infection.

Are we to assume that after the Factor VIII concentrates were deliberately spiked with whichever antigen to a potentially fatal virus, that there was no way to know for sure if the heat-treatment had killed-off the pathogen, until haemophiliac patients received the "spiked" factors and either went on to contract the virus or not?

IS THIS AN EXAMPLE OF NON-CONSENSUAL RESEARCH?

Source: Notes of the Haemophilia Reference Centre Directors Meeting, Blood Products Laboratory, Elstree, 10 December 1984:
http://www.taintedblood.info/tlfiles/UKHCDO Meeting BPL 10 December 1984.pdf
Type: Recovered Document - Notes of the Haemophilia Reference Centre Directors Meeting. 10 December 1984.
Location: UK
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1984, 10 December - Haemophilia Directors Decide Whether to Inform Patients of HTLV III Results
In the minutes of the Haemophilia Reference Centre Directors meeting in December 1984, under the heading of "Dealing with haemophiliac patients", it states:

"Patients who asked their HTLV-III antibody test results should be informed of them otherwise it is up to individual Directors to decide whether or not they wish to tell patients their results." (Page 1, final paragraph)

"...Moreover the virologists considered that there was no evidence that haemophiliacs already HTLV III antibody positive would suffer if they received further doses of antigen (this view is based entirely on theoretical consideration)." (Page 2, paragraph 1, line 8)

December 1984: "Most agreed that untreated BPL Factor VIII could continue to be used until heat treated Factor VIII was available from Elstree." (Page 2, paragraph 1, line 14.)

Note: These minutes demonstrate that doctors were testing haemophilia patients' blood for HTLV III without consultation. This practice denied the patient's rights concerning pre- and post-test counselling.

Source: http://www.taintedblood.info/tlfiles/Meeting of the Haemophilia Reference Centre Directors 10 December 1984.pdf
Type: Recovered Document - Meeting of the Haemophilia Reference Centre Directors. 10 December, 1984
Location: UK
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1984, 10 December - Early HTLV-III Antibody Test - Available Only on a Research Basis
In a meeting of the Haemophilia Reference Centre Directors in December 1984, the EARLY existence and availability (in 1984) of the HTLV-III Antibody screening test is discussed:

Dr Tedder: "the Gallo cell line was available for investigation although the USA had made the isolates difficult to obtain." (Page 1, item 2, point i)

Dr Craske: Under the subject heading "Availability of Tests", Dr Craske advised that currently, the reagents were only available on a research basis, and that substantial resources would be required to enable the proposed workload to be undertaken. (Page 2, point ii)

Source: Notes of the Haemophilia Reference Centre Directors Meeting, Blood Products Laboratory, Elstree, 10 December 1984:
http://www.taintedblood.info/tlfiles/UKHCDO Meeting BPL 10 December 1984.pdf
Type: Recovered Document - Notes of the Haemophilia Reference Centre Directors Meeting. 10 December 1984
Location: UK
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1984, 10 December - HCDO Meeting - Haemophiliac Patients Regarded as a Research Project
In a meeting of the Haemophilia Reference Centre Directors in December 1984, the testing of haemophiliac patients for HTLV III (now termed HIV) is discussed:

"Inconsistencies in the results of the tests reveal that a study of the haemophiliac population would provide the invaluable material to increase our knowledge of the disease. [Deleted Name] has developed the same test as [Deleted Name] using the Gallo isolate obtained with his permission through Professor Weiss."

"I believe a study of haemophiliac patients could be regarded as a research project now and Dr Mortimer could provide facilities for doing these tests." (Point a. Paragraph 2.)

Note: Firstly, the choice of wording used here is disgraceful. Secondly, it is clear from this, that the Physicians' main priority was studying haemophiliacs as a 'research project' - whilst people were dying.
Again, we are seeing RESEARCH dictating and overriding CLINICAL NEED.

Source: http://www.taintedblood.info/tlfiles/Meeting of the Haemophilia Reference Centre 10 Dec 1984.pdf
Type: Recovered Document - Meeting of the Haemophilia Reference Centre Directors. 10 December 1984
Location: UK
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1984, 10 December - Dr Kernoff - Informing Patients of Testing Results Considered Irrelevant
The notes of a meeting of the Haemophilia Centre Directors held at BPL (Blood Products Laboratory), Elstree, on 10th December 1984, show a somewhat laissez-faire attitude to testing for AIDS:

Dr Jones: "A long discussion took place on whether persons found to be +ve were to be informed. Several differing views were expressed. It was agreed that each clinician would decide for each case depending on the facts of the case but in general to provide information if asked for." (page 4)
Dr P. Kernoff commented that as some 70% of haemophiliacs are now +ve it may be considered irrelevant if one tells or doesn't tell the results of testing. (page 5)
Note: These doctors should have given a strong line of advice to follow - that patients and spouses should not only be informed of the test results, but also that they had a right to know. Dr Kernoff might have considered it "irrelevant", but we doubt that the intimates and spouses of the patients with haemophilia would have thought so.
Source: Notes of the Haemophilia Reference Centre Directors Meeting, Blood Products Laboratory, Elstree, 10 December 1984:
http://www.penroseinquiry.org.uk/finalreport/pdf/SNF0013850.PDF
Type: Penrose Evidence File
Location: UK
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1985 - Studies - NANBH - Unsterilised Large Donor Pool Concentrates...
Studies reveal almost 100% transmission of NANBH following treatment with unsterilised large donor pool clotting factor concentrate.

Hay et al. report that progressive liver disease in patients with haemophilia is an understated problem.

Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Studies
Location: UK
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1985 - UKHCDO - Colombo et al. - NANBH Still Transmitted Despite Heat-Treatment
Evidence emerges that Non-A Non-B Hepatitis is still being transmitted in haemophilia blood products even after the concentrates have been heat-treated to eliminate HIV. 11 of 13 Previously Untreated Patients (PUPs) go on to develop Non-A Non-B Hepatitis, despite heat-treatment.
Source: Colombo M, Mannucci PM, Carnelli V, Savidge GF, Gazengel C, Schimpf K. Transmission of non-A, non-B hepatitis by heat-treated factor VIII concentrate. Lancet. 1985;2(8445):1-4.
Type: Development
Location: UK
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1985 - DoH - SNBTS - Work on New Facility in Scotland Only Just Starting
As a test becomes available for HIV, the Government is still dragging it's heels. The work on the new facility in Scotland is only just being started, and consequently, it takes a further 2 years to implement heat-treatment in Scotland.

Extract:
The Scottish National Blood Transfusion Service were around 18 months behind the Bio Products Laboratory in England in producing a heat-treated product which was subsequently found to have eliminated the hepatitis C virus.

Source: Hepatitis C and Heat Treatment Of Blood Products For Haemophiliacs In The Mid 1980s. Scottish Executive - Health Department. October 2000, Page 2, Point 3
http://www.scotland.gov.uk/Resource/Doc/158690/0043060.pdf
(77 KB, 22 pages.)
Type: Development
Location: Scotland
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1985 - Armour
According to an internal memorandum in 1985, Armour know that the heat treatment procedures they are using in the manufacture of their factor VIII are not inactivating viruses.

The memorandum also demonstrates the standpoint of Armour Pharmaceuticals in 1985 that to withdraw the product from circulation would seriously affect their profits and their corner of the market.

Source: Witness Evidence of Dr. Peter Jones, Lindsay Tribunal Report. Page 457.
Type: Internal Memorandum
Location: USA
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1985 - MRC - Human Growth Hormone - CJD
The human growth hormone programme discontinues in 1985 following reports of the first deaths from CJD in the United States, after which synthetic hormone is used.
Source: Clare Dyer, Legal Correspondent, British Medical Journal, 1996:313:185 (27 July)
http://bmj.bmjjournals.com/cgi/content/full/313/7051/185?
Type: BMJ Article - Legal - CJD
Location: UK
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1985, beginning - Protein Fractionation Laboratory, Scotland - Inadequate Heat-Treatment Method
In a DHSS letter of 1985, late seroconversions of haemophiliac patients who became HTLV-III positive, despite receiving heat-treated factor VIII are discussed in relation to variations in the adequacy of heat-treatment methods:

"Certain heat-treated products are not being subjected to sufficient inactivation. There is considerable variation between the methods used by commercial firms and in particular the Protein Fractionation Laboratory in Liberton in Scotland introduced on a short term basis a very quick method which they thought might inactivate the virus, at the beginning of the year. I believe that it is this latter which may be implicated in the information I have received."

Source: http://www.taintedblood.info/tlfiles/DHSS Heat Treated FVIII 28 Nov 1985.pdf
Type: Recovered Document - Letter DHSS, Hannibal House, 28 November, 1985
Location: Scotland
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1985, January - Krever Report
HTLV-III and LAV are shown to be related viruses.
Source: Krever Commission Report (1997), Vol 3, Part IV, International Milestones: HIV and AIDS 1981-8.
Type: Development
Location: USA
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1985, January - DHSS - BPL - Date Set for Heat Treatment
DHSS confirms that BPL has begun the process of heat-treatment and that routine heat-treatment of all factor VIII concentrate will start in April 1985.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 33, Page 932, Paragraph 2.
Type: DHSS Confirmation
Location: UK
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1985 - Haemophilia Society Bulletin - Allegation against the Press Dramatizing the AIDS Problem
In the Haemophilia Society's Bulletin, Volume 34 of 1985, under the heading "AIDS PROBLEM", the following rather unbelievable statement is made:

"And although the press has been dramatizing the AIDS problem and the risk of imported blood coming into this country, I think it is very important not to forget that without the imported product the quality of life of those who need Factor VIII and Factor IX would have been much poorer."

Background: What was known: In August 1983, the UK's CDSC reported the first case of AIDS in a UK haemophiliac, a patient from Wales, who had received factor VIII concentrate imported from the United States.

By October 1983, the USA had seen 15 AIDS cases in haemophiliacs and the UKHCD (Haemophilia Centre Doctors) were privy to this information and could reasonably have been expected to be able to work out that the risk from US commercial products was much higher. With reference to the U.K. Situation, 2 haemophiliac cases of AIDS (A1 and A4) were also known about in October 1983.

Note: The Bulletin statement speaks for itself. However, it should be noted that cryoprecipitate could have been used. [Edgware made highly potent cryoprecipitate that had levels of 100 i.u. of factor VIII or more - consistently.] Moreover, on 17th October 1983, in the midst of the AIDS crisis, we know that a doctor present at a meeting of the UKHCDO stated that she could obtain "unlimited supplies of cryoprecipitate". The Press were right to dramatize, when more than two-thirds of the infected haemophiliac community have since passed away. 'Quality of life' hardly comes into it.

Source: http://www.taintedblood.info/tlfiles/Haemophilia Society The Bulletin 1985.pdf
Type: Recovered Document - The Bulletin, Haemophilia Society, Vol 34, No.1 1985
Location: UK
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1985, January - FDA - First AIDS Antibody Test for Screening
The FDA approves the first AIDS antibody test, which is immediately used to screen the USA's blood banks.
Source: Pear R. (1985), "AIDS blood test to be available in 2 to 6 weeks", the New York Times, March 3, 1985.
http://www.avert.org/his81_86.htm
Type: Testing Development
Location: USA
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1985, circa 17 January - Ministers Aware of Genetically Engineered Factor VIII - Prior to 1986
In a recovered document entitled "Self Sufficiency in Blood and Blood Products in the UK" the following is stated:

"Ministers will be aware that Factor VIII, the most significant blood product, has been produced in the laboratory by genetic engineering methods." (Point 7. Lines 1 & 2.)

"...it is considered that it will take up to five years at least for this product to be available on a commercial scale." (Point 7, lines 4 & 5)

"This possible development has been borne in mind and the plans for BPL are sufficiently flexible to allow the refining of such products from genetically engineering source material when available in the future." (Point 7. Lines 6-8)

Note: We know that Ministers had knowledge of genetically engineered Factor VIII from as early as November 1982. We should point out, that this knowledge was 3-4 years prior to the completion of the BPL re-development project of 1986.

Background: We know from a DHSS internal circular, around 3 years earlier, that a discussion of genetic engineering or the cloning of Factor VIII took place as early as November 1982. (See Additional Source below).

Source: http://www.taintedblood.info/tlfiles/Self Sufficiency in Blood Products circa 1985.pdf
Additional Source:
http://www.taintedblood.info/tlfiles/DHSS Genetically Engineered Factor VIII 30 Nov 1982.pdf
Type: Recovered Document - Self Sufficiency in Blood and Blood Products in the UK. Date circa 17 January 1985
Location: UK
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1985, 19 January - Lancet - Heterosexual Transmission of "Pre-AIDS" to Partners
In a Lancet Article published on 19th January, 1985, the issue of transmission to partners and children is discussed:

"...Concentrate-treated haemophiliacs may transmit this agent to their spouses or children, resulting in pre-AIDS or AIDS."
"Our observations support the theory that pre-AIDS can be transmitted heterosexually to partners not otherwise at risk for AIDS and suggest that AIDS can be transmitted to the offspring of haemophiliacs either vertically, through the female sexual partners, or through close maternal-infant or paternal-infant contact."
Source: Lancet Article:
http://www.penroseinquiry.org.uk/finalreport/pdf/LIT0015042.PDF
Type: Penrose Evidence File
Location: UK
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1985, 22 January - Kenneth Clarke - Naive Comment - Do We Need This & Heat-Treatment of Blood?
In an internal circular dated 22 January 1985, Kenneth Clarke makes the following disturbing comments:

"Before we all panic further, it is presumably the case that the ending of the collection of blood from homosexuals greatly reduces the risk from blood collected in this country?

Also, as only haemophiliacs have died and they may have had Factor VIII from American blood, is it the case that we have not had one AIDS fatality from blood donated in this country yet?"

'...only haemophiliacs...' What does he mean by this? Whatever he meant, only 6 weeks later we find distasteful comments from the DHSS Finance Division regarding the potential SAVINGS that could be generated when haemophiliacs died. (see related entries link below)

Kenneth Clarke, 22 January 1985: "Do we need this and heat treatment of the blood?"

Note: The extent of naivety in these comments should not surprise us. We only need to remind ourselves that this apparent lack of understanding emanates from a man who had already stated 13 months earlier (in October 1983) that as far as he knew no human blood plasma was imported into the United Kingdom by the NHS. What rubbish. There should have been no question in his mind as to whether blood products (as opposed to plasma) were being imported from the USA in 1983.

Note: Even more remarkably, in November 1983, Mr Kenneth Clarke (then Minister for Health) offers us further counsel without knowledge: "There is no conclusive evidence that (AIDS) is transmitted by blood products." He obviously wasn't paying attention to the Council of Europe Recommendations on coagulation factors and AIDS at the Lisbon meeting in May 1983. (see related entries link below for a plethora of proof.)

No wonder in recent correspondence (2007) with Taintedblood, Mr Kenneth Clarke unfortunately appears to be experiencing 'selective memory loss'.

Source: http://www.taintedblood.info/tlfiles/Kenneth Clarke Comment 22 January 1985.pdf
Type: Kenneth Clarke Internal Circular. Dated 22 January 1985
Location: UK
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1985, February - Dr Lawlor referring to SBTS - Factor IX Suspended
The Scottish Blood Transfusion Service (SBTS) suspends the issue of its own factor IX in February of 1985. During this period of suspension of its own factor IX, they investigate the thrombogenic effect of heat treating their product.
Source: Lindsay Tribunal Report. Page 53
Type: Witness Evidence
Location: Scotland
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1985, February - The Lancet
A study shows that use of heat-treated factor concentrates prevents HIV infection in haemophiliacs.
Source: Krever Commission Report (1997), Vol 3, Part IV, International Milestones: HIV and AIDS 1981-8.
Type: Study
Location: UK
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1985, February - First Issue of HT2 / Trial Issue of HT3 Factor VIII
First issue of HT2 factor VIII (heated at 70C for 24 hours) along with a trial issue of HT3 factor VIII (heated at 80C for 72 hours).
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Developments - Trial
Location: UK
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1985, 1 February - BPL Product License Necessary Despite Crown Immunity
In the 17th meeting of the CBLA held at BPL on 1st Feb 1985, the fact that BPL had no product licence was discussed:
"Dr Thomas referred to the excess of Factor 8 now on the market saying that non-heat treated Factor 8 was no longer available commercially. He believed the Committee on the Safety of Medicines was licensing standard Factor 8 when heat-treated without trial. He pointed out that BPL had no product license and thought that a license was necessary, despite Crown privilege. Dr Lane stressed the desirability of producing this new safer product (Factor 8Y) as early as possible."

Note: These minutes also mention a meeting with Kenneth Clarke.

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1985, 19 February - FDA / Public Health Service
The Food and Drug Administration issues a memorandum about the implementation of the Public Health Service recommendations. It states that tests will soon be licensed and that blood centres should voluntarily begin testing as soon as supplies become commercially available.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 767
Type: Memorandum
Location: USA
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1985, circa 26 February - Application for Ethical Approval - Consent Form
In 1985, circa 26 February, a consultant with the initials C.A.L. made an application for ethical approval to the Ethics of Medical Research Sub-Committee for Medicine and Clinical Oncology. Each protocol being submitted for ethical approval was required to have an accompanying "consent" form. The form asks a number of important questions with serious implications, however, the answers the consultant provides leave a lot to be desired:

5. What is the Object of the Project? (explain in terms appropriate to an intelligent layman)

"To follow up haemophiliacs negative for anti HTLV-III (viral cause of AIDS) who are treated with heated SNBTS Factor VIII in which it is anticipated the virus will have been killed."
According to the Penrose Inquiry transcripts, on Day 39, Tuesday, 28th June, 2011, Professor Christopher A. Ludlam appeared again to give oral evidence. His answers to the questions on the form in LOT0014973 were cross-examined, as follows:

Under Question 16: "Will informed consent be obtained from all subjects?" Mr. Di Rollo: And your answer is?

Prof. Ludlam: "Their cooperation will be sought."

Mr. Di Rollo: Is there something wrong with not just a simple "yes" there? What's the difference between "yes" and "their cooperation will be sought?"

Under Question 18: How will consent be recorded?

Prof. Ludlam: "I was not planning to record this."

Q. Were all of the patients who were looked at here aware that they were HIV positive?

Prof. Ludlam: A lot of these patients were HIV negative.

Q. Yes, I understand that. That was a bad question. I'm sorry. The question I meant to ask you is: all of those who were HIV positive that you were looking at, were they aware that they were HIV positive?

Prof. Ludlam: They might not have been.

Q. Those that aren't, how would they give informed consent for this work?

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1985, March - FDA Informs United Kingdom DHSS of New Testing Requirements
Blood is now routinely tested in the United States, and the FDA informs the UK's DHSS of these new requirements.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: New requirements
Location: USA
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1985, 1 March - Expert Advisory Group on AIDS - Freezer Studies Without Consent
In March 1985, the Expert Advisory Group on AIDS gives consideration to the idea of conducting studies on samples collected from patients without consent:

"[Deleted Name] expressed his unease at 'freezer' studies being carried out on samples collected from individuals attending STD clinics who would not necessarily have given consent for such investigations to be carried out." (Page 4, point 12).

Source: Minutes of the Expert Advisory Group on AIDS. 1st March 1985:
http://www.taintedblood.info/tlfiles/Expert Advisory Group on AIDS 1 March 1985.pdf
Type: Recovered Document - Expert Advisory Group on AIDS - Screening Test Sub-Group. Dated 1st March 1985.
Location: UK
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1985, 2 March - Abbott - Department of Health and Human Sciences / FDA
The Department of Health and Human Services announces that HIV test kits manufactured by Abbott have been approved and licensed by the Food and Drug Administration.
Source: Krever Commission Report (1997), Part IV, Chap. 27, page 768 and Krever Commission Report (1997), Vol. 3, Part IV, International Milestones: HIV and AIDS 1981-8.
Type: USA HIV test approval
Location: USA
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1985, 5 March - DHSS Disgraceful Comment - Doomed Haemophiliacs Will Generate Savings
In a DHSS Finance Division circular of 5 March 1985, we read of disturbing figures regarding the infections of UK haemophiliacs:

"If, however, your figures are right Britain's haemophiliac population, which I think is 5000, could be very seriously affected. You question whether the one-third sero-positive is accurate. The table below suggests what the implications of one-third sero-positive and two-thirds sero-positive would be:

One-third sero-positive Two-thirds sero-positive
Sero-positive 1,500 3,000
AIDS within one year 120 240
AIDS eventually 600 1,200

Frightening figures.

The Finance Division circular goes on to make the following utterly monstrous comment:

"Of course the maintenance of the life of a haemophiliac is itself EXPENSIVE, and I am very much afraid that those who are already doomed will generate SAVINGS which more than cover the COST of testing blood donations. At this stage I do not want to have your minute or mine copied outside Finance Division." [Quoted verbatim. DHSS Finance Division: FA1. Dated 5th March 1985.]

Note: We find it hard to believe that the DHSS dared to commit such a disgraceful comment to paper. It is disgusting beyond belief that whilst haemophiliacs are dying, the first thing going through the minds of the FINANCIERS is the MONEY that will be saved by the deaths of these 'EXPENSIVE' haemophiliacs and that such SAVINGS can be spent on blood screening.

The DHSS Finance Division should be ashamed of themselves.

Source: http://www.taintedblood.info/tlfiles/DHSS Doomed Haemophiliacs Comment 05 March 1985.pdf
Type: Circular DHSS Finance Division FA1. Dated 5th March 1985.
Location: UK
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1985, 12 March - Mr Kenneth Clarke - Awareness that Imported FVIII was Subject to the Medicines Act
In a House of Commons debate on 12th March 1985, the subject of product licences with respect to imported heat-treated factor VIII was discussed as follows:

Dr. McDonald asked the Secretary of State for Social Services how many applications for product licences in respect of imported heat-treated factor VIII have been received by his Department; and how many were granted in 1984 and in 1985.

Mr. Kenneth Clarke: Further to my reply on 20 February at columns 498-500, to my hon. Friend the Member for Peterborough (Dr. Mawhinney), all the seven applications made since November 1984 for product licences under the Medicines Act for heat-treated factor VIII were granted earlier this year. All of these were for imported products.

Dr. McDonald asked the Secretary of State for Social Services if exactly similar tests are applied to imported factor VIII products as to Blood Products Laboratory products; and if he will make a statement.

Mr. Kenneth Clarke: The Central Blood Laboratories Authority, which is a special health authority, ensures the safety and quality of products made at its blood products laboratory. Imported, commercially manufactured factor VIII is subject to the formal licensing arrangements under the Medicines Act 1968.

Dr. McDonald asked the Secretary of State for Social Services if he will place in the Library a copy of his Department's studies of the economics of self-sufficiency against the continued importation of factor VIII products.

Mr. Kenneth Clarke: I refer the hon. Member to my reply to the hon. Member for Portsmouth, South (Mr. Hancock) on 19 February at columns 446-47.

Note: Two years earlier (Sept. 1983) Travenol were strongly criticised by the Sub-Committee of the CSM for writing promotional letters making unjustified claims on improved safety margins in respect of AIDS infection.

Source: http://hansard.millbanksystems.com/written_answers/1985/mar/12/factor-viii
Type: Hansard - House of Commons Debate, 12th March 1985, vol 75, c117W.
Location: UK
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1985, March (late) - ELISA Testing
Testing for HIV with the new ELISA test begins late March 1985.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 768.
Type: ELISA Testing
Location: USA
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1985, April - BPL
In April 1985, Blood Products Laboratory (BPL) starts heat-treatment of Factor VIII concentrate.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Development
Location: UK
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1985, April - National Hemophilia Foundation - Recommends Against Recall
The National Hemophilia Foundation reverses its earlier recommendation for the recall of factor concentrates that may have been derived from a donor with AIDS.

Now that heat-treated factor concentrates are available, it recommends against recall because:

"HTLV-III [HIV] appears to be adequately killed under currently licensed heat treatment procedures."

Only non-heat-treated factor concentrates, it said, should be recalled.

The NHF now informs its members that heat-treated factor concentrates "may be the preferred products" for infants and children under 4 years of age with severe hemophilia and for newly identified hemophiliacs who have never been treated with factor concentrates.

Note: It has now taken 23 months for the National Hemophilia Foundation to revise its treatment recommendations regarding carrying on treating with concentrates despite the product recalls which began in May 1983. They now recommend physicians to alter treatment.

Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 758.
Additional Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 770-1.
Type: Decision Reversal
Location: USA
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1985, 12 April - The Death of a Baby from AIDS - Coroner's Verdict: 'Death by Misadventure'
In a DHSS Internal Circular of 12th April 1985, we learn that Coroners can report any case of death by misadventure in which it is considered that future occurrences could possibly be prevented by some organisation...

AIDS - Death of a Baby

"The death of a baby from AIDS, at Gt Ormond Street hospital on Wednesday night has been attributed to an American blood transfusion. It has stimulated Press interest in the safety of blood transfusions here; and particularly about progress on a blood screening test within the National Blood Transfusion service. The Coroner's inquest verdict of death by misadventure is likely to attract Press attention too."

"The Coroner of St Pancras recorded the verdict of death by misadventure without disputing the Consultant's view that the baby died of AIDS following a blood transfusion in America. No pathological examination has been attempted."

"Coroners may report any case of death by misadventure in which it is considered that future occurrences could possibly be prevented by some organisation. The St. Pancras Coroner is writing accordingly to CMO. Officials do not consider the need for proper evaluation should in any way be prejudiced by the Inquest result."

Source: http://taintedblood.info/files/1244268883AIDS_Death_of_a_Baby.pdf
Type: DOH Freedom of Information document released 20th May 2009. (DHSS Internal Circular HS1A Hannibal House dated 12th April 1985.)
Location: UK
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1985, May - HIV Antibody Testing
HIV-antibody testing begins in the USA.
Source: Krever Commission Report (1997), Vol 3, Part IV, International Milestones: HIV and AIDS 1981-8.
Type: Testing Development
Location: USA
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1985, May - FDA Request - Withdrawal of Non-Heat Treated FVIII
The FDA requests a meeting with the 4 US pharmaceuticals to order them to comply with their voluntary agreement to withdraw non-heat treated product from the market.

Dr. Harry M. Meyer, the FDA's regulator of blood products at the time, later states in legal papers that:

"It was unconscionable for them to ship that material overseas."
Source: First Amended Class Action Complaint (2004) (Case No. C032572 PJH). Page 22.
Additional Source: New York Times Article May 22, 2003.
Type: FDA Request
Location: USA
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1985, 2 May - Transmission of HTLV-III to Chimpanzees Using Brain Material from Aids Patients
In a report on a visit to the USA International Conference on AIDS held in Atlanta between 14-17th April 1985, we learn about the awareness that HTLV III could be found in the brain...

HTLV-III in the Brain:

"23. It is believed that the HTLV III itself is responsible for an encephalopathy. The titre of virus in the brain [of?] patients is known to be high. Transmission of HTLV III to chimpanzees has been achieved by using brain material from AIDS patients." (see page 5 of the pdf)
Source: http://taintedblood.info/files/1244158560Report_on_Aids_Conference.pdf
Type: DoH FOI Document released 20.05.09. Report on a Visit to the USA and the International Conference on AIDS
in Atlanta
. 2nd May 1985.
Location: USA
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1985, 7 May - FDA - Memorandum
The FDA issues memorandum that reaffirms the importance of providing US donors with an opportunity to withdraw their blood confidentially.
Source: Report (1997), Vol 3, Part IV, Chap. 27, page 751.
Type: Memorandum
Location: USA
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1985, 13 May - DHSS - Product Recall - Armour Factor VIII Batch Y69402
In May 1985, the DHSS writes to the Directors of the BTS (England and Scotland) regarding a recalled batch of Factor VIII Armour Y69402 (Product Licence PL/0231/0038):

"I am writing to advise you that [deleted name] have recalled batch number Y69402 of the above product because one of the US donors of the original plasma, although passing all screening tests at the time, has subsequently developed AIDS."

Note: See link to Chimpanzee Oxford Letter (below), "Use of products on a named-patient basis is often justifiable but by-passes these controls which have been established in the interest of patients".

Background: Also commercial products imported into the UK would have been sourced two years earlier at which time (circa 1983) a screening test for HIV was not officially available.

Source: http://www.taintedblood.info/tlfiles/DHSS Armour Product Recall Letter May 1985.pdf
Additional Source: Chimpanzee Oxford Letter:
http://www.taintedblood.info/tlfiles/Oxford Chimpanzee Letter.pdf
Type: Recovered Document - DHSS - Letter to Blood Transfusion Service Directors. 13th May, 1985
Location: UK
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1985, June - DHSS / BPL
Despite the DHSS confirmation that BPL should have begun routine heat-treatment of all factor VIII concentrate by April 1985, unfortunately by June 1985, a substantial number of haemophilia centres are unbelievably still using non-heat-treated domestic Factor VIII concentrate. Domestic heat-treated Factor IX concentrate was not yet available.

One reason for the continued use of non-heat-treated factor IX concentrate is that the heat-treated variety has to be purchased from foreign commercial sources, whereas the domestic non-heat-treated variety is supplied free of charge by the BPL.

Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 33, Page 932, Paragraph 2.
Type: Statement
Location: UK
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1985, June - New York Blood Center (NYBC) - Solvent Detergent License Obtained from FDA
The New York Blood Center ("NYBC") obtains a license from the FDA to implement the solvent detergent process for manufacture of Factor VIII.
Source: Krever Report (1997), Vol 3, Part IV, Chap. 27, page 756.
Report of the Tribunal of Inquiry: Lindsay Final
http://www.taintedblood.info/tlfiles/Lindsay_Final.pdf
Type: FDA License
Location: USA
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1985, June - American Association of Blood Banks, Red Cross, Council of Community Blood Centers
HIV testing is implemented by the American Association of Blood Banks, the Red Cross, and the Council of Community Blood Centers.

They release recommendations for notifying donors testing positive for the test as well as recipients of previous donations from infected individuals.

Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 774.
Type: HIV Testing Development
Location: USA
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1985, 28 June - Suspected Aids in a Recipient of a Blood Transfusion - DHSS Fear of an Inquest
In an FOI document released on20th May 2009, we discover a DHSS minute (from June 1985) where a suspected case of Aids in the recipient of a blood transfusion was reported.

"Further to my minute of the 26 June I have heard this afternoon that this patient is very ill indeed and not expected to live long. Initial antibody tests on his blood are positive but have not yet been confirmed however the clinical history is fairly indicative."

"It seems probable that in the event of his death the case will be reported to the Coroner which could result in an Inquest."

Note: It is interesting to see the degree to which the DHSS anticipated, possibly feared, the prospect of a Coroner's Inquest. We believe this still to be the case today - since an Inquest can always return the verdict of unlawful killing.

Source: http://taintedblood.info/files/1244156779Recipient_of_Blood_Transfusion_Suspected_Aids.pdf
Type: DoH FOI Document released 20.05.09. Internal minute of MED SEB. 28th June 1985.
Location: UK
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1985, July - FDA - Recommendation of Blood Product Look-Back Policy
FDA recommends that blood and plasma centres establish a "look-back" policy for blood products that may be contaminated.
Source: Krever Commission Report (1997), Vol 3 Part IV, International Milestones: HIV and AIDS 1981-8.
Type: Recommendation
Location: USA
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1985, July - Armour H.T. Factor VIII - Two Cases of Seroconversion in UK Haemophiliacs
Two cases of seroconversion in haemophiliacs are associated with the use of H.T. Factorate - a heat-treated factor VIII concentrate manufactured by Armour.
Source: Krever Commission Report (1997) Vol 3, Part IV, chapter 33, pg 933.
Type: Development
Location: USA
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1985, July - Trials of a New High Purity Product 8Y
Trials of a new, high purity product, 8Y, are being conducted in selected patients.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Trials
Location: UK
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1985, July - Dr Prince - Non-A Non-B Hepatitis - Chimpanzee Tests
Research by Dr. Prince published in the Lancet in 1985 shows that the original tests done on chimpanzees with Non-A Non-B hepatitis were not conclusive.

In clinical trials, patients given heat-treated factor concentrates still went on to develop NANB Hepatitis.

Dr. Prince said that the reason the chimpanzee study was inaccurate was because of a design flaw in the study, in that the amount of virus that was used to spike the factor concentrates given to the chimpanzees was too low.

Source: Lindsay Tribunal Report. Page 416.
Type: Lancet Article
Location: UK
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1985, 4 July - DHSS Request an Assurance That No Further UK Haemophiliacs will be Infected
In a DHSS internal circular of 4 July 1985, the author asserts that all UK-produced Factor VIII has been heat-treated at Elstree as of April 1985.

"[Deleted name] of NIBSC has just informed me that since 19 December 1984, all imported Factor VIII cleared by NIBSC has been heat-treated. All Elstree material received since April has been heat treated and Scottish supplies have been heat treated since the 23 January 1985."

At the end of the circular we discover the following handwritten request:

"Can you please translate this into an assurance I can give to the SoS next week that no haemophiliacs will be infected in the UK from now on."

Note: Whether of not this assurance was given to the Secretary of State, we are saddened to report that in the same month (July 1985), there were two cases of seroconversion in haemophiliacs associated with the use of Armour's H.T. Factorate - an apparently heat-treated factor VIII concentrate.

Background: With regard to UK-produced Factor VIII, it should be pointed out that within just 4 more months, evidence is found of haemophiliacs seroconverting to become HTLV-III (HIV) positive, despite being given heat-treated Factor VIII manufactured in the United Kingdom.

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1985, 6 July - Colombo et al - The Lancet - Infectivity Trials of NANB Hepatitis in Children
In an infectivity trial in human beings contrasted against an animal model involving chimpanzees, 11 out of 13 Previously Untreated Patients (PUPs) go on to develop Non-A Non-B Hepatitis after being administered commercial heat-treated Hemofil-T made from around 5,000 North American pooled plasma donations, collected in 1982, 1983, and 1984.

The findings were contrasted with the absence of non-A, non-B hepatitis in chimpanzees given the same heated concentrate. The Hemofil-T lot numbers were: 820628A, 820817A, 840120A, 830121A, 833010A.

Of the 13 patients, 9 of them were aged between only 3 months old and 15 years of age. Five of these patients were just 12 month-old babies. In fact, there were only 2 patients who were over the age of 18.

Consent:
On page 2, under the heading 'Patients', it states that those who met the criteria "gave their written informed consent".

Note: Eight of these patients were in the age-range of a 3-month-old baby up to 3 years of age and would therefore not even have been able to write. In the case of the 9 patients under the age of 18, their parents would have been required to give their informed written consent.

We have to wonder if ANY parent would knowingly consent to hepatitis infectivity trials of this kind, especially if they were genuinely informed and cognizant of exactly what was involved.

Source: Colombo M., Mannucci P.M. et al (1985) Transmission of Non-A Non-B Hepatitis by Heat-Treat Factor VIII Concentrate. The Lancet. Saturday 6 July 1985. 2(8445):1-4.
http://www.taintedblood.info/tlfiles/The%20Lancet%20July%206%201985.pdf
Type: Recovered Document - Copy of Lancet Article Within the DOH FOI Released Documents
Location: UK
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1985, 18 July - BPL - Contaminated Factor VIII Batches HLA3046 and HLB3046
In 2 letters of 18 July 1985, the Head of Quality Control at BPL writes to 2 different regional centres of the National Blood Transfusion Service about contaminated unheated Factor VIII batches:
  • HLA3046 (557 vials)
  • HLB3046 (559 vials)
The batches of unheated Factor VIII were compromised by the inclusion in the plasma pool of blood taken from a donor who later went on to develop AIDS symptoms and serology.

"The plasma was prepared on 5th November, 1982 and fractionated at BPL in March, 1983. You received 170 vials of HLB3046 as part of your allocation for June, 1983." (page 1 paragraph 2)

"Obviously product recall is not relevant - the product date-expired in April, 1984 and was almost certainly used long before that." (page 1 paragraph 3)

Source: http://www.taintedblood.info/tlfiles/Contaminated Batches HLA3046 and HLB3046 July 18 1985.pdf
Type: Letter from Head of Quality Control, BPL to NBTS. Dated 18 July 1985.
Location: UK
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1985, 25 July - EEC - Product Liability Directive
The EEC adopts a Product Liability Directive (85/374/EEC).
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1985, 30 July - Expert Advisory Group on AIDS - Hepatitis B and HTLV-III Testing Without Consent
In the minutes of the Expert Advisory Group on AIDS in July 1985, it is clear that the Expert Group felt that it was acceptable to conduct Hepatitis B and HTLV-III antibody testing without always gaining the patient's consent:

"Patient's permission for hepatitis B testing was not always sought and, with a variety of tests being taken, it should not be necessary to inform the patient in all cases that these included a test for HTLV-III antibody." (Page 4, from line 8)

"It was also agreed that the result of the HTLV-III antibody test should not be awaited before undertaking other tests which might be critical in the treatment of the patient. [Deleted Name] said that with hepatitis B it was now acceptable that other tests should be done while the result of the hepatitis B test was awaited." (See page 4, from line 11.)

Source: http://www.taintedblood.info/tlfiles/Expert Advisory Group on AIDS 30 July 1985.pdf
Type: Recovered Document - Minutes of the Fifth Meeting of the Expert Advisory Group on AIDS. Dated 30th July 1985.
Location: UK
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1985, 15 August - DHSS - Deputy Chief Medical Officer - BPL Heat Treatment
Deputy Chief Medical Officer of the DHSS writes to all haemophilia centre directors telling them that the Blood Products Laboratory (BPL) has been heat-treating Factor VIII concentrate since April (85) and gives them current information about the availability of these concentrates.

The letter states that only limited supplies have been available in the past and although production levels have increased, it is still necessary to import heat-treated factor concentrates.

Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 33, Page 932, Paragraph 3.
Type: DHSS Letter
Location: UK
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1985, 15 August - DHSS - Deputy Chief Medical Officer - Overconfident on Heat Treatment
In a DHSS letter of August 1985, the Deputy Chief Medical Officer, states that it was apparent that certain Haemophilia Centres were still using Factor VIII that had not been heat-treated:

Dr E. Harris: (DCMO) I understand that all commercial Factor VIII imported into this country is also heat treated. There would thus appear to be no longer any need to use un-heat-treated Factor VIII concentrate.

Note: This statement turned out to be overconfident and wrong, as within only six months, Armour Batch A28306 infects haemophiliac boys in the Birmingham area (Lindsay Tribunal Report, pg 53) and by March 1986, Armour has to be questioned by the DHSS about the efficacy of its heat-treatment methods. (Krever Report, Volume 3, Part IV, Chapter 33, page 933).

Source: http://www.taintedblood.info/tlfiles/DHSS Deputy Chief Medical Office 15 August 1985.pdf
Type: Recovered Document - DHSS letter from the Deputy Chief Medical Officer. 15 August 1985
Location: UK
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1985, 23 August - John Patten - Date Set for Donor Screening
The Parliamentary Secretary for Health, John Patten, announces that routine screening of all blood donations for antibodies to the AIDS virus should be introduced by mid-October 1985.
Source: Department of Health and Social Security Press Release 85/277, Dated 23 August 1985.
http://www.taintedblood.info/tlfiles/John Patten - Date Set for AIDS Screening Test.pdf
Type: DHSS Press Release - Donor Screening
Location: UK
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1985, September - BPL - New 8Y Heat-Treated Product
BPL begins general issue of its new 8Y heat-treated factor VIII.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Development
Location: UK
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1985, September - Dr. Margaret Hilgartner - Hemophilia Physician - Cornell Medical Center
Dr. Margaret Hilgartner understates the risk of AIDS and exaggerates the need for factor concentrate products.

"The current risk of persons with hemophilia developing AIDS is directly related to their need for blood products to stop bleeding. The risk is extremely low."
"There is no evidence to warrant changing the current use of Factor VIII or Factor IX."

Note: The evidence was just the opposite. Non-heat treated products were known by September 1985 to be contaminated with HIV by virtue of testing done at the CDC in the Summer of 1984.

Source: First Amended Class Action Complaint (2004) Case No. C032572 PJH. Pages 34-35.
Type: Article ECHO Magazine Vol. 6, September 1985
Location: USA
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1985, 26 September - DHSS Press Release - Effectiveness of Heat Treated Blood Products
In a DHSS Press Release in September 1985, the steps to safeguard the recipients of blood and blood products from AIDS infection is discussed:

"Preparations for the introduction of routine screening of all blood donations in mid-October are well advanced. The blood clotting agent Factor VIII needed by haemophiliacs is now being heat treated. And the major redevelopment, costing 38 million, of the Blood Products Laboratory in Elstree should ensure our self-sufficiency in blood products by the end of 1986." (page 2, paragraph 3, lines 4-6)

Note: The DHSS seem quite confident that the heat-treatment process is working effectively. However, it should be pointed out that 2 months later, (28th November 1985), evidence is found of haemophiliac patients seroconverting to become HTLV-III positive despite being given heat-treated Factor VIII.

Source: http://www.taintedblood.info/tlfiles/DHSS Press Release 26 September 1985.pdf
Type: Recovered Document - DHSS Press Release 26 September 1985
Location: UK
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1985, October - The Lancet - Misleading Article Catastrophically Misrepresenting Safety
Dr John Petricciani, the director of the Division of Blood and Blood Products of the FDA, writes in The Lancet that:
"Infectious LAV/HTLV-III [HIV] is unlikely to be present in currently licensed heat-treated factor concentrates, and that the use of such factor concentrates should not result in additional cases of AIDS in persons with hemophilia."

Note: See the Find Related Entries link below to learn why this article was so misleading.

Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 756.
Type: Article
Location: USA
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1985, October - Dr Lawlor referring to BTST - Un-Heated Factor IX
The BTSB continues to issue un-heat treated factor IX as well as heat treated factor IX from October to the end of December 1985. It is about half and half.
Source: Lindsay Tribunal Report. Page 52
Type: Witness evidence
Location: UK
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1985, October - Armour - Third Case of Seroconversion in a Haemophiliac
A 3rd case of seroconversion in an haemophiliac is associated with the use of Armour's H.T. Factorate.
Source: Krever Commission Report (1997) Vol 3, Part IV, Chap. 33, page 933.
Type: Development
Location: USA
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1985, October - Dr Lawlor referring to SBTS
The Scottish Blood Transfusion Service (SBTS) overcome the difficulties of the suspension of its own Factor IX with investigations into the thrombogenic effect of heat treating the product and they go back into production of heat treated factor IX.
Source: Lindsay Tribunal Report, Page 53
Type: Witness Evidence
Location: Scotland
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1985, 2 October - BPL - Heat-treated Factor IX Issued
Heat-treated Factor IX is issued from BPL.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Development
Location: UK
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1985, 2 October - BPL Letter - Mr Snape - Un-heated Factor IX Still In Use After 2nd October 85
In a letter from Mr Snape of BPL it is stated that October 2nd 1985 is the date when heat treated Factor IX is issued in the United Kingdom. Mr Snape goes on to say that he gathers that there is still some un-heated product in use after this date in the UK.
Source: Lindsay Tribunal Report. Page 53
Type: BPL Letter. Mr Snape.
Location: UK
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1985, 7 October - BPL - Trials of Heat-Treated Factor IX Concentrate
In a letter of October 1985 from the Product Services Department of BPL to Haemophilia Centre Directors, it is clear that infectivity trials are still being conducted in 1985, at least 3 years after the knowledge of the threat of AIDS:

"This new product, containing a nominal 600 iu per vial has been dry heated at 80C for 72 hours to inactivate viral agents (including hepatitis and AIDS viruses) but it cannot yet be assumed to be free from viral infection." (Page 2 paragraph 2)

BPL, October 1985: "Clinical trials at specified Haemophilia Centres are now in progress to gain evidence of reduction or elimination of viral transmission, particularly NANBH virus transmission. If you have under your care, suitable patients who would be able to participate in a clinical trial, the enclosed protocol should be used only for this purpose." (Page 2, paragraph 5)

"In accordance with the regulatory requirements, the product should be issued by clinicians on a named patient basis until a product licence has been granted." (Page 2, Paragraph 6)

Source: http://www.taintedblood.info/tlfiles/BPL Letter to Haemophilia Centre Directors 7 October 1985.pdf
Type: Recovered Document - BPL Product Services Department letter to the Haemophilia Centre Directors. 7 October 1985.
Location: UK
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1985, 14 October - UK Donor Screening
Blood donors in the UK are now screened.
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.
Type: Development
Location: UK
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1985, 15 October - BTSB - Commences Donor Testing for HIV
On 15th October 1985 the Blood Transfusion Services Board commences the testing of donors for HIV.
Source: Lindsay Tribunal Report. Page 52
Type: Screening development
Location: UK
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1985, 21 October - HTLV-III Survey at UK Haemophilia Centres - 44% Found to be HIV Positive
In the minutes of the 16th Meeting of the United Kingdom Haemophilia Centre Directors the results of an HTLV-III (now termed HIV) antibody survey in UK Haemophilia Centres were presented by Dr Rizza.

"The response from Centres had been good and information had been received from 81 Centres, giving results for HTLV-III tests on a total of 2,570 patients." (see page 6, last paragraph)

  • Analysis of the results showed that 44% of the Haemophilia A patients tested were found to have HTLV-III antibodies.
  • Therefore, 1,130 out of 2,570 Haemophilia A patients tested in the UK in October 1985 were HIV positive.

Note: We have to ask ourselves how infection rates with figures this high could have happened? Were we not informed by Dr Christine A. Lee via a Haemofact leaflet of May 1984, that the incidence of AIDS in UK Haemophiliacs was merely 1 in 1,000, representing only 0.1%? So how did this happen?

Background: The DHSS Finance Division were right about one thing, in March 1985 they expressed fears that the haemophiliac population (circa 5,000) could be very seriously affected indeed, with two-thirds possibly already positive with as many as 1,200 eventually going on to develop AIDS. (see Related Entries link below)

Source: http://www.taintedblood.info/tlfiles/UKHCD Minutes 21 Oct 1985.pdf
Type: Minutes of the 16th Meeting of the UKHCDO. 21 October 1985
Location: UK
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1985, 21 October - Patients Asking Questions about Risk of Transmission to Their Wives / Partners
In the minutes of 16th meeting of the United Kingdom Haemophilia Reference Centre Directors in October 1985, Dr Ludlam and Dr Craske present a comprehensive questionnaire that is designed to study HTLV-III (now HIV) prevalence in household / sexual 'contacts' of haemophilia patients:

"Dr. Hill (Birmingham) agreed that back-up counselling was needed for the patients and families involved."

"Professor Bloom wondered whether, a comprehensive questionnaire could be handled by the peripatetic expert in sexual epidemiology."

"Dr. Jones (Newcastle) said that the proposed study had been discussed by the Reference Centre Directors at 2 recent meetings and he had made known his strong objections to the study. He thought the proposed study was insensitive, unscientific and unethical. It would cause great anxiety to the families and it did not take into account bisexuals or homosexuals."

"Professor Bloom emphasised that no one was forced to participate in the study. The Haemophilia Society's representatives were asked for their views and Mr. Knight replied that the Society was not yet convinced that Haemophilia Centres were the right place for this kind of study to be done."

"Dr Hill felt that patients would co-operate with Centres as they were already asking these questions about the risk of antibody positivity and transmission to wives. The validity of the study was queried if Centres provided only numbers of patients and contacts involved, rather than identifying individual patients and households."

"Dr. Craske replied that he would prefer the individuals and their families to be identified, rather than simply be given total numbers by each Centre."

Background: Two years earlier, the UKHCDO possessed detailed knowledge of the risk of AIDS to the spouses of haemophiliacs. That was in October 1983. Why then, 2 years later, are these physicians having difficulty deciding whether to issue an epidemiological questionnaire to haemophiliac patients and their families? There was NO question; the patients needed to know their status in order to avoid transmission to partners/spouses.

Note: We are asking ourselves whether the questionnaire was designed to reinforce known statistics already held regarding transmission of HIV to partners, or was it designed to investigate possible modes of infection by seropositive haemophiliacs. We would suggest the use of the word 'epidemiology' implies that the questionnaire was merely a study of the incidence and distribution of HIV? This is further supported by Dr Craske's intriguing comment that: "In due course when the few HTLV III [positive] sexual partners are identified...". Does this mean that Craske was already aware of the number at this point?

Source: http://www.taintedblood.info/tlfiles/UKHCD Minutes 21 Oct 1985.pdf
Type: Minutes of the 16th Meeting of the UKHCDO. 21 October 1985. See page 6, paragraph 3.
Location: UK
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1985, 24 October - Sir Donald Acheson CMO - Draft Speech to PHLS on AIDS
In the final draft of a speech by the then CMO, Sir Donald Acheson to the PHLS in October 1985, we discover a certain overconfidence regarding his belief that no new cases of AIDS infection should occur in the future in the haemophiliac group...

Sir Donald Acheson, October 1985: "These data show that HTLV3 infection:

  1. has increased in prevalence among homosexuals in London. Elsewhere it may also be increasing in prevalence but remains less common that [than?] in the capital;

  2. It is prevalent among haemophiliacs, particularly sufferers from Type 'A' haemophilia. Fortunately however no new cases of infection should now occur in this group;

  3. it has appeared, so far at low prevalence among female partners of haemophiliacs;

  4. it remains relatively uncommon among drug abusers."

NOTE: We must point out that the CMO's comment was somewhat overconfident since that very same month, there was the third is a spate of cases of seroconversion in UK haemophiliacs associated with the use of an imported commercial concentrate; Armour's H.T. Factorate - and this was only 2 and a half months after the Deputy Chief Medical Officer (Dr E. Harris, DCMO) had expressly stated that:

"all commercial Factor VIII imported into this country is also heat treated. There would thus appear to be no longer any need to use un-heat-treated Factor VIII concentrate." (August 1985).

Apart from the complete underestimation of the ongoing risk to spouses, by November 1985, there is hearsay evidence that even more haemophiliac patients are seroconverting to become anti-HTLV III positive despite having received heat-treated Factor VIII. Even as late as February 1986, we still have a new HIV infection in a UK haemophiliac caused by Armour batch A28306.

Source: http://taintedblood.info/files/1243387745Draft_CMO_Speech_to_PHLS_on_AIDS.pdf
Type: DOH FOI Document - CMO Final Draft of Speech to PHLS on AIDS. 24 October 1985.
Location: UK
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1985, 25 October - BTSB - First HIV Positive Donor
By 25th October 1985, BTSB records discovering the first HIV positive donor.
Source: Lindsay Tribunal Report. Page 52
Type: Development
Location: UK
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1985, 29 October - National Blood Transfusion Service - Anti-HTLV III - Screening
In a letter to the DHSS from the NBTS West Midlands Regional Health Authority in October 1985, the NBTS shows startling overconfidence:

"I should add that we have screened over 24,000 donations by now, without discerning a single seropositive case...."

"I think the public and Parliamentary concern is exaggerated and misplaced. Much greater funds and concern should be invested in the more difficult area of influencing attitudes and behaviour rather than allowing them to be dissipated and assuaged in the area of blood transfusion."

Note: This statement is overconfident and unhelpful.

Source: http://www.taintedblood.info/tlfiles/NBTS Screening 29 October 1985.pdf
Type: Recovered Document - NBTS Letter, 29 October, 1985
Location: UK
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1985, 29 October - NBTS - Quarantined Stocks of Pooled Plasma for Fractionation
In a letter from the NBTS to the DHSS in October 1985, the following overconfident comment is made:

"Fortunately for us, we were able to start anti-HTLV-III screening unofficially from the 23rd September 1985."

"Naturally we cannot comment on quarantined stocks of pooled plasma for fractionation at Elstree but assume that the heat inactivation will cover that aspect."

Background: The NBTS are ASSUMING that BPL Elstree's heat-treatment process will inactivate any possible virus in pooled plasma that was QUARANTINED for some reason. They unwisely put a lot of trust in the heat-inactivation process, especially if they are using untested or virus-implicated plasma pools. We know that only 2 months later several haemophiliac patients become HTLV-III positive after receiving Factor VIII; despite it allegedly being heat-treated.

Source: http://www.taintedblood.info/tlfiles/NBTS DHSS Quarantined Stocks 29 October 1985.pdf
Type: Recovered Document - NBTS Letter to DHSS, 29 October, 1985
Location: UK
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1985, November - House of Commons / Social Services Committee
The House of Commons requests its Social Services Committee briefly review the measures taken in the United Kingdom to reduce the transmission of HIV through blood and blood products.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chapter 33, Page 927, Paragraph 1.
Additional Source: U.K. House of Commons, Third Report of the Social Services Committee. Problems Associated with AIDS, Vol. 1. London: HMSO, 1987.
Type: Request for Review
Location: UK
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1985, November - BTSB - Armour - Dr Lawlor Testimony
The BTSB receives a total of 450 vials of Armour product in November and December of 1985. It is decided that hospitals will order their own product, therefore 350 vials are sent back to Armour. It then appears as if Armour re-issues the product direct to the hospitals.
Source: Lindsay Tribunal Report. Page 53
Type: Witness Evidence
Location: USA
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1985, 28 November - DHSS - Heat Treated Factor VIII - Late Seroconversions
In a DHSS letter of November 1985, there is mention of hearsay evidence that haemophiliac patients are seroconverting to become anti-HTLV III positive despite being given heat-treated Factor VIII. Possible causes include:

"They have seroconverted some months after having received a non-treated product"

"Certain heat-treated products are not being subjected to sufficient inactivation. There is considerable variation between the methods used by commercial firms and in particular the Protein Fractionation Laboratory in Liberton in Scotland introduced on a short term basis a very quick method which they thought might inactivate the virus, at the beginning of the year. I believe that it is this latter which may be implicated in the information I have received."

"The Blood Products Laboratory at Elstree were rather late starters in heat treating their Factor VIII but are probably now producing the safest product in the world. There is good evidence that the prolonged and high temperature treatment, is inactivating the non-A non-B agent. It has been apparent for some time that commercial heat treated Factor VIII does not inactivate this agent."

Source: http://www.taintedblood.info/tlfiles/DHSS Heat Treated FVIII 28 Nov 1985.pdf
Type: Recovered Document - Letter DHSS, Hannibal House, 28 November, 1985
Location: UK
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1985, December - Dr Lawlor referring to BTST
Blood Transfusion Services Board discontinues issuing un-heat-treated factor IX.
Source: Lindsay Tribunal Report. Page 52
Type: Witness Evidence
Location: UK
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1985, December - Armour / BTSB (Dr Lawlor) - Armour Product No Longer Stocked
The BTSB no longer stocks Armour product, as of December 1985.
Source: Lindsay Tribunal Report. Page 53
Type: Witness Evidence
Location: USA
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1985, December - National Hemophilia Foundation
In December 1985, the National Hemophilia Foundation recommends that physicians prescribe only heat-treated concentrates for patients with severe hemophilia.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 771.
Type: Recommendation
Location: USA
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1986 - BPL - A New Facility - Bio Products Laboratory, Elstree is Opened
A new facility "with the capacity for national self-sufficiency" is opened at Bio Products Laboratory, Elstree.
Source: Martlew 1997
Type: Development
Location: UK
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1986, February - Dr Peter Jones
Dr Peter Jones, at an AIDS conference in February 1986, reports on the haemophiliac seroconversion cases related to the use of imported heat-treated Factor concentrates.
Source: Krever Commission Report (1997), Vol 3, Part IV, chap. 33, page 933.
Type: AIDS Conference Report
Location: UK
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1986, circa 13 February - CMO - Donald Acheson - Patients Infected by Heat-Treated Factor 8
In a Guardian article of Tuesday, 15th April, 1986, we learn that 2 months earlier, Dr Donald Acheson, Chief Medical Officer, dismissed evidence of patients being infected by heat-treated Factor 8:

"Doctors in Amsterdam reported that a 27-year-old man had been infected after being given supplies of the blood clotting agent which had been heat-treated to kill the virus..."

"Senior Department of Health and Social Security officials were studying the report yesterday."

"Two months ago the Government's Chief Medical Officer, Dr Donald Acheson, dismissed evidence that Dutch patients had been infected by heat-treated Factor 8, and assured British haemophiliacs that US supplies were safe."

Legal Note: There was little question, in this case, of a clear causal relationship between the conduct of a US blood product manufacturer and the result of this commercial product on the patient - since the Amsterdam-based physicians had reported in the Lancet that their patient had been given exclusively heat-treated Factor VIII originating from the United States.

NOTE: There were grave consequences to the CMO's dismissal of the Dutch evidence. Only a week later, (on 21 February 1986) Armour batch A28306 is found to be the likely cause of HIV infection in a UK haemophiliac. By late September '86, Armour's H.T. Factorate is again reported to have led to seroconversions in another two haemophiliacs in the UK.

Source:
http://archive.guardian.co.uk/Repository/ml.asp?Ref=R1VBLzE5ODYvMDQvMDUjQXIwMDIwMg==&Mode=Gif&Locale=english-skin-custom
Type: Guardian Article - Aids threat remains in safe Factor 8. Tuesday, 15 April 1986.
Location: UK
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1986, 21 February - Dr Lawlor referring to Armour - Late Seroconversions
Armour batch A28306 is the likely cause of HIV infection in a UK haemophiliac on 21 February 1986.

(The Armour product was heat treated at 60 Centigrade for 30 hours and was made from plasma of untested donors. This product is associated with up to 12 cases of late seroconversion.)

Background: Only a week or so earlier, the Government's CMO, (Chief Medical Officer), Dr Donald Acheson, dismissed evidence that Dutch patients had been infected by heat-treated Factor 8, and assured British haemophiliacs that US supplies were safe.

NOTE: It should be noted that the Amsterdam-based physicians had reported in the Lancet that their patient had been given exclusively heat-treated Factor VIII originating from the United States.

Source: Source: Lindsay Tribunal Report. Page 53
Additional Source:
http://archive.guardian.co.uk/Repository/ml.asp?Ref=R1VBLzE5ODYvMDQvMDUjQXIwMDIwMg==&Mode=Gif&Locale=english-skin-custom
Type: Witness Evidence
Location: UK
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1986, 21 February - Dr Lawlor referring to Armour - Infection from Batch A28306
The untested plasma that Armour batch A28306 originates from was made into similar types of Armour product which infect haemophiliac boys in the Birmingham area.
Source: Lindsay Tribunal Report. Page 53
Type: Witness Evidence
Location: UK
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1986, March - DHSS / Armour - Efficacy of Heat Treatment
DHSS questions Armour about the efficacy of its heat-treatment methods.

Departmental staff meet with Armour officials to review the data on inactivating viruses.

Source: Krever Commission Report (1997), Vol 3, Part IV, Chapter 33, page 933.
Type: Questioning / Meeting
Location: USA
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1986, 11 March - Expert Advisory Group on AIDS - Safety of Heat-Treated Factor VIII
In the minutes of the Expert Advisory Group on AIDS in March 1986, the safety of Factors VIII and IX are discussed with reference to the effect of heat-treatment:

"...She said that [Deleted Name] had made a statement at the Newcastle Conference in February to the effect heat-treated Factor VIII was not safe with regard to transmission of HTLV III..." (Page 4, Point 9.2)

"...He had subsequently written to the CSM advocating that material manufactured by [Deleted Brand, probably Armour] in particular should be withheld." (Page 4, Point 9.2, lines 5-6)

Note: In England, 12 patients received treatment from the implicated batch. One of the patients who sero-converted as a result of this batch, was only a mild haemophiliac who had not received any treatment in the previous 6 years. (Page 4, Point 9.2, ii.)

Background: It is also worth noting that these infections occurred just 7 months after the Deputy Chief Medical Officer expressly stated that "all commercial Factor VIII imported into this country is also heat treated." (see link below to DHSS letter 15 August 1985)

Source: http://www.taintedblood.info/tlfiles/Expert Advisory Group on AIDS 11 March 1986.pdf
Additional Source: DHSS letter from the Deputy Chief Medical Officer. 15 August 1985:
http://www.taintedblood.info/tlfiles/DHSS Deputy Chief Medical Office 15 August 198
Type: Recovered Document - Minutes of the Expert Advisory Group on AIDS. 11 March 1986
Location: UK
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1986, 12 March - Headmaster Letter, School - Antibodies Present in your Child?
Parents in Coventry area receive a letter from a Middle School Headmaster demanding to know "whether or not the antibodies are present in your child"!
Source: Ainscough H. Letter to family in Coventry area. 12 March 1986.
Type: Letter
Location: UK
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1986, April - The Lancet
The Lancet issues reports of HIV infection among haemophiliacs using dry heat-treated factor concentrates.
Source: Krever Commission Report (1997), Vol 3, Part IV, International Milestones: HIV and AIDS 1981-8.
Type: Report
Location: UK
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1986, May (end of) - Krever Commission Report (1997)
There are now 17 haemophiliac cases of AIDS in the UK.

There are now 6 cases of UK transfusion patients with AIDS.

Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 33, page 928.
Type: Statistics
Location: UK
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1986, June - US Blood Banks
US blood banks announce that recipients of blood or blood products made from donations by donors who have tested positive for HIV should be located.
Source: Krever Commission Report (1997), Vol 3, Part IV, International Milestones: HIV and AIDS 1981-8.
Type: Announcement
Location: USA
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1986, 12 June - Armour - Heat-Treated Factor VIII - Spouses Left Exposed to Infection
In a DHSS internal circular of 12 June 1986, we read of evidence that seroconversion has occurred in a haemophiliac patient after having received Armour 'Heat-Treated' Factor VIII. Clearly, the author of the circular and treating doctors are in no hurry whatsoever to inform the person concerned:

"The patient who remains well has yet to be approached and this will not occur until the physicians return from annual leave."

Note: A rather poor decision was made to approach the patient until the physician returned from annual leave. This meant that the patient himself was not informed as to the results of his test and was thus NOT able to protect his sexual partner(s).

Background: As early as October 1983, the UKHCDO had shown knowledge of the risk of AIDS to the spouses of haemophiliacs, and we believe it to be quite outrageous that 3 years later physicians are still putting partners at risk.

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1986 (Mid) - BPL Re-development Project Costs Escalate
The costs of BPL re-development project escalate to around 52m; however the project remains fully-funded owing to Government's commitment to self-sufficiency.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Statement
Location: UK
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1986, July - National Institutes of Health
At a National Institutes of Health consensus conference, it is agreed that since testing is imperfect, US blood banks should introduce confidential unit exclusion.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 751.
Type: Consensus Conference / NIH
Location: USA
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1986, 24 July - BPL Provides 8Y Material for Virgin Haemophiliac Trials
In a letter from N. Pettet, Product Services Manager at Blood Products Laboratory (BPL) to Dr R. J. Perry, Director of the PFC in Edinburgh, we can see clearly that BPL were involved in the provision of 8Y material for trials involving "Virgin" haemophiliacs:

"Following your letter on your requirements for "virgin" haemophiliacs in Scotland and Northern Ireland, I tried to contact you by telephone last Thursday in order to begin supply as soon as possible. As you were down in London it was obviously difficult!"
"Provided that you were agreeable and that the patients met the criteria, and given agreement by the Haemophilia Directors involved, Jim can provide 8Y from batches set aside for trial purposes."

On page 2, there is a disturbing revelation regarding the status of the source material:

"There is one point, however, that you need to consider. Current batches of 8Y on issue, are not made from certified anti-HIV screened donations. The first individually screened product will not be released for issue until August.
Subsequent batches will all be made from screened plasma. In light of press statements from Armour Pharmaceutical, and rumours from the Haemophilia Service this may have implications for both laboratories. In addition, two parliamentary questions have been submitted on this problem relation to both Elstree and PFC. A written DHSS reply was due today."

In a further letter of 24th July, we can see that BPL are confirming the supply of 50 vials:

"I have now confirmed that BPL are happy to supply 50 vials of 8Y to PFC on the understanding that, in the event that the material is used in suitable virgin patients, appropriate serial samples would be taken to contribute to their overall infectivity study."

Note: Until this discovery, we had wrongly thought that the evidence relating to the use of "virgin" haemophiliacs was limited to Scotland (specifically, the Dr John Cash letter of 17th February 1984 - see Related Links below). However, due to this letter, we can see that the horrors of trials involving "virgin" haemophiliacs have been brought right home to BPL, England.

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1986, 4 August - Transmission of NANB Hepatitis to a Virgin Patient
A letter from R.J.Perry to Dr Frank Boulton of the Blood Transfusion Service at the Royal Infirmary, Edinburgh, reports the disturbing news that non-A non-B hepatitis had been transmitted to a "virgin" haemophiliac patient.

NANB Transmission in Virgin Haemophiliacs:

"Could you let me know the batch of FVIII involved in the transmission of NANB Hepatitis to Dr Ludlam's virgin patient. While this outcome of treatment is not surprising we need to know the batch number and dose to keep our surveillance cross referencing records complete."
Source: http://www.penroseinquiry.org.uk/pdf/SNB0076022.PDF
Type: Penrose Evidence File
Location: Scotland
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1986, September - DHSS AIDS Leaflet Includes Mention of Haemophiliacs
The DHSS "AIDS leaflet" is revised for a 4th time, and now includes mention of haemophiliacs.

It now states that if haemophiliacs have received non-heat-treated factor concentrates at any time since 1978, then they are at risk of contracting AIDS.

Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 33, page 930.
Type: DHSS donor leaflet
Location: UK
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1986, September - FDA Blood Products Advisory Committee - Confidential Unit Exclusion
In September 1986, the practice of confidential unit exclusion also receives the endorsement of the FDA's Blood Products Advisory Committee.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 751.
Type: FDA BPAC Endorsement
Location: USA
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1986, late September - Armour - H.T. Factorate Haemophiliac Seroconversions
Another 2 seroconversion cases are reported in persons with haemophilia in the UK who have been treated with Armour's H.T. Factorate.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 33, page 933.
Type: Development
Location: UK
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1986, October - FDA Blood Banks - Recommendation of Confidential Unit Exclusion
In October 1986, the FDA once again issues a recommendation to US blood banks in support of confidential unit exclusion, stating that, at a minimum, the procedure should allow for removal of designated units, strict confidentiality of the donor's decision and a confidential environment in which to make the decision, HIV testing of all donated units, notification of donors with positive test results, and assurances to donors that units confidentially excluded would be used only for laboratory testing.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 752.
Type: FDA Recommendation
Location: USA
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1986, 6 October - DHSS / Armour Voluntary H.T. Factorate Withdrawal
DHSS staff meet again with Armour officials. At this meeting, Armour agrees to voluntarily withdraw all H.T. Factorate from the U.K. market.

The company also agrees to relinquish its product licences for all factor VIII concentrate products.

Source: Krever Commission Report (1997), Vol 3, Part IV, Chapter 33, page 933.
Type: Meeting
Location: USA
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1986, 29 October - BPL / BTSB - Witness testimony of Dr Lawlor - Heat-Treatment
A delegation from Elstree (BPL) fractionation centre in London visit the BTSB. This delegation meet Mr Keyes and Mr Hanratty and inform them that the Elstree centre is fractionating factor VIII and using a heat treatment protocol of 80° centigrade for 72 hours (HT3).

It is noted that in 18 months of use, no evidence of Non-A, Non-B Hepatitis has emerged, where previously all recipients of factor concentrates had developed Non-A, Non-B hepatitis.

The product is now presumed safe in terms of HIV.

Source: Lindsay Tribunal Report. Page 55
Type: Witness Evidence
Location: UK
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1986, 20 November - BTSB / BPL - From the testimony of Dr Lawlor
The Minutes of a BTSB Board Meeting notes that the Board is not making progress towards the Government's policy on self-sufficiency. Because of this, 2 companies, Cutter and Armour, are going to fractionate plasma for BTSB.

In this same Board Meeting, visitors from Elstree are seeking Anti-D material, and it is agreed to make some available to them.

They quote a price for factor IX fraction for consideration of plasma. It is noted that Elstree will not be taking any outside work until 1st January 1988, thereupon the entire plasma programme will have to be reviewed.

Source: Lindsay Tribunal Report. Page 55
Type: Board meeting minutes
Location: UK
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1986, 20 November - DoH had Knowledge in 1982 that AIDS could be Transmitted by Blood Products
In the House of Commons on Thursday 20th November 1986, Mr. Dobson asks Mr. Newton when the Department first became aware that Aids could be transmitted through blood and blood products:

Mr. Dobson asked the Secretary of State for Social Services when his Department first became aware that acquired immune deficiency syndrome could be transmitted through blood and blood products.

Mr. Newton [pursuant to his reply, 17 November 1986, c. 78]: We became aware in 1982 of reports from the United States of America that haemophiliacs were contracting AIDS. Although the mechanics of infection was not known it was presumed that it had been transmitted through the use of blood products such as Factor VIII. Evidence that the AIDS infection could also be transmitted by blood transfusion emerged from the United States of America in 1983.

Note: According to Hansard, Dr Gerard Vaughan, then Minister for Health, had knowledge, sometime in 1981, possibly from as early as May, of the threat of contaminated blood supplies which were being imported from the United States. This is one of the earliest warnings that we are aware of (so far) and we are astonished to learn of how early this awareness was, and that so little was done. Clearly, we are still not being told everything. (see related entries link below.)

We also know that in July 1982, the DHSS had early knowledge in of "a sort of virus" found within plasma taken from "homosexual drug-takers" which went undetected when the plasma was tested but when it was used for Factor VIII, it became active again.

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1986, 4 December - Graham L. Ross - Early Suggestion of No Fault Compensation
In a letter to Mr D Watters of the Haemophilia Society, solicitor Graham Ross somehow reveals as early as 1986 (nearly 3 years before the Haemophilia HIV Litigation got properly underway) that in relation to investigating the cases of haemophiliacs:

"the final outcome would be some element of no fault compensation for all haemophiliacs".

Note: It is extremely odd that a solicitor should mention "no fault compensation" (which could be considered a "compromise") in an opinion disclosed so early on. In fact, the opinion was committed to paper nearly 3 years before the Haemophilia / HIV Litigation really got off the ground.

Source: Graham L. Ross, J. Keith Park & Co. Solicitors, Southport. Letter to Mr D Watters, Haemophilia Society, London, dated 4 December 1986:
http://www.taintedblood.info/tlfiles/Legal_Aids_HS_1986.pdf
Type: Graham L. Ross, J. Keith Park & Co. Solicitors, letter to Mr D Watters, Haemophilia Society, dated 4 December 1986
Location: UK
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1986, 5 December - Concern over Indemnities for Patients in Trials Who Suffer Adverse Effects
On 5th December, 1986, Dr F. E. Boulton (Deputy Director of the Edinburgh and South-East Scotland Regional Blood Transfusion Service) writes to Dr John Cash, National Medical Director, SNBTS:
"...I have discussed the situation with Christopher Ludlam concerning the use of patients for half-life and recovery studies and he still has some reservations."
"I know that Crown Immunity has been removed from BPL and I assume (although I have not heard specifically) that the same applies to PFC. Christopher is concerned about the situation as far as indemnity to patients who suffer as a result of being infused with the trial material. I have a strong feeling that he will be unwilling to agree to such trials unless there is a specific commitment by the SHHD that any patients who suffer adverse effects as a result of the infusion will be given appropriate compensation."

Note: We would have to disagree that Crown Immunity was removed from BPL or PFC in 1986. At most, this is about the right point in time when these laboratories were becoming aware of the coming changes in legislation, such as Product Liability under CPA in 1988. Despite the Medicines Act being in force from 1968, the products of BPL failed to come within the scope of the licensing arrangements required under the Act and it was not until 1st April 1991 that Crown Immunity came to an end.

Source: http://www.penroseinquiry.org.uk/pdf/SNB0076274.PDF
Type: Penrose Evidence File
Location: Scotland
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1987 - Cutter, Alpha, Baxter - Detergent Process - Delayed Implementation
CUTTER, ALPHA and BAXTER are now using the solvent detergent process to virally inactivate their Factor VIII blood products.

Note: 7 years earlier, all four US plasma companies were approached by Dr. Edward Shanbrom, who presented his solvent detergent treatment process. Sadly, all 4 companies declined his process and as a result countless hemophiliacs' lives were lost.

Source: First Amended CLASS ACTION COMPLAINT (2004) Case No. C032572 PJH. Pages 20-21.
Type: Development - Solvent Detergent Process
Location: USA
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1987 - Hyland - Recombinant FVIII - Human Trials
Hyland begins the first human clinical trials of a recombinant FVIII concentrate.
Source: Baxter Vaccines - Milestones
http://www.baxtervaccines.com/?node_id=1247
Type: Recombinant Human Trials
Location: USA
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1987 - Chiron Corporation - Discovery of Hepatitis C Virus (HCV)
A team of scientists, working at the Chiron Corporation, discover, clone and sequence the Hepatitis C virus - the causative agent of Non-A Non-B Hepatitis (NANBH).

The pioneering work of scientist Michael Houghton, Ph.D. and colleagues Qui-Lim Choo, Ph.D. and George Kuo, Ph.D. goes back as far as 1982.

Source: Chiron Corporation (Part of the Novartis Group)
http://www.chiron.com/public/about/pr/101100cbt.jsp
Type: Development
Location: USA
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1987, circa - Margaret Thatcher - The Correct Course of Redress Is Through the Courts...
In the book "The End of Innocence", we learn that sometime in 1987, the Prime Minister of the time, Margaret Thatcher, held the belief that the correct course of redress for the haemophiliacs who had suffered the HIV contamination was through the courts:

...And so a campaign got underway. Letters went to MPs, sympathetic stories appeared in the press, people threatened to sue their district or regional health authority.

Margaret Thatcher had always insisted that the correct course of redress was through the courts and it was clear she had sought advice on the matter.

The former Prime Minister's legal stance was also referred to in an article in The Scotsman, on 12th December 1990:

The announcement was seen as a breakthrough on the issue for the Government which, under Mrs Thatcher's leadership, had insisted that compensation would remain a matter for the courts.

Source: http://taintedblood.info/files/1243366529Courts_Quote_End_of_Innocence.pdf
Additional Source:
http://www.taintedblood.info/files/1440870237AIDS_PRESS_CUTTING_121290.pdf
Type: Extract - Simon Garfield. The End of Innocence - Britain in the Time of AIDS. Pg. 208. The Scotsman - Haemophiliac victims of AIDS offered 51m deal. 12 December 1990.
Location: UK
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1987 - Armour - Solvent Detergent Process
Armour is still not using the solvent detergent process to virally inactivate their Factor VIII blood products.
Source: First Amended Class Action Complaint (2004) Case No. C032572 PJH. Page 21.
Type: Development
Location: USA
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1987 - BMJ Article
In 1987, the British Medical Journal publishes an article that is critical of the years of neglect by central management at BPL Elstree. The author is National Medical Director of the Scottish National Blood Transfusion Service.
Source: BMJ Vol 1295 No 6599 pps 617-619.
Type: Article
Location: UK
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1987, 9 February - Position of Blood and Blood Products under the Consumer Protection Bill
On 9 February 1987 Peter Lambert, of the Department of Trade and Industry, Consumer affairs Division 5, wrote to Mr G. Calder, SHHD (Scottish Home and Health Department) regarding the position of blood and blood products under the Consumer Protection Bill.

"We have considered at some length the position of blood and blood products under both the EC product liability Directive and the Bill."
"For the purposes of the Bill, blood and blood products would in our view fall within the meaning of "goods" as defined in clause 45(1) and the provision of such products would fall within the meaning of "supply" as defined in clause 46(1) either as a sale, a contract for work and materials or, in the case of the NHS, products supplied in the course of a statutory function."
"We are not persuaded that there is any justification in removing the supply of blood and blood products from the legislation in the way you suggest (non-supply provides a defence under clause 4(1)(b)); and indeed it was recognised by DHSS, in the course of the negotiations, that they would be covered."
"Such products would be considered defective for the purposes of Part I of the Bill only if their safety is not such as person generally are entitled to expect. That is a test which is to apply to all products and it would seem unjustified to make an exception in the case of blood products."
"The article you enclosed in your letter points out that at any given time infectious agents that are unknown to medical service may exist, undetected and undetectable, in blood products. AIDS (until 1985) is one such example. The case of a product containing an undetectable defect is covered by clause 4(1)(e) of the Bill which provides that it will be a defence for a person to show that the state of scientific and technical knowledge was not such that a producer of products of the same description as the product in question might be expected to have discovered the defect. The availability of this defence should, I hope, go some way to removing your concern about blood products."
Source: http://www.penroseinquiry.org.uk/finalreport/pdf/SGH0050155.PDF
Type: Penrose Evidence File
Location: UK; Scotland
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1987, March - Blood Banks / CDC - Recommendation that Patients be Tested
Blood banks endorse the CDC's recommendation that patients transfused between 1978 and April of 1985 be tested.
Source: Krever Commission Report (1997), Vol 3, Part IV, International Milestones: HIV and AIDS 1981-8.
Type: Endorsement
Location: USA
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1987, 23 March - Miss Cunningham / BTSB - HT3
It is now known (in 1987) that dry heating is ineffective in preventing Non-A Non-B Hepatitis. In a scientific meeting, Miss Cunningham, discusses various methods of heat treatment, and notes that the British protocol of pasteurisation of 80 Centigrade for 72 hours is effective against transmission of Non-A, Non-B Hepatitis and AIDS.
Source: Lindsay Tribunal: Page 56
http://www.digitalop.com/ihs/ole/images/Lindsay_Tribunal.doc
Type: Scientific Meeting
Location: UK
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1987, April - SNBTS - Heat Treated Factor VIII
The SNBTS is able to make their Factor VIII product available for clinical use. The product is heat treated at 80 degrees C for 72 hours.

Note: The arrival of this heat-treated product has been delayed by 2 years due to the Government dragging it's heels over the work on the new fractionation facility in Scotland which was begun in 1985.

Source: Hepatitis C and Heat Treatment Of Blood Products For Haemophiliacs In The Mid 1980s. Scottish Executive – Health Department. October 2000.
http://www.scotland.gov.uk/library3/health/hepatitis_c.pdf
Type: Development - Heat Treatment
Location: Scotland
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1987, May - Social Services Committee
18 months after the Social Services Committee began its task, they issue the report on AIDS, which endorses the actions taken by the National Blood Transfusion Service in safeguarding the blood supply.

The SSC states: "We commend the way in which the Blood Transfusion Service has responded to the challenge of AIDS, protecting donor and recipient alike, and urge a constant review of policy and procedures to maintain that high standard."

Source: Krever Commission Report (1997), Vol 3, Part IV, Chapter 33, page 927.
Additional Source: U.K. House of Commons, Third Report of the Social Services Committee. Problems Associated with AIDS, Vol. 1. London: HMSO, 1987.
Type: SSC Report 1987
Location: UK
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1987, 11 June - Government Election - Change of Minister
The Conservatives are still in power for a third term with Margaret Thatcher as PM. John Moore is appointed Secretary of State for Health and Social Security on 13th June.
Source: Wikipedia, encyclopedia
http://en.wikipedia.org/wiki/Secretary_of_State_for_Health#Secretary_of_State_for_Health
Type: Political climate
Location: UK
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1987, 3 July - BMA - Doctors Decide to Test for AIDS in Secret.
On 3rd July, 1987, the Guardian's Medical Correspondent, Andrew Veitch reported that the Health Department was questioning the legality of a new BMA practice - to test for AIDS in secret.

"The BMA's annual representative meeting in Bristol voted by 183 votes to 140 for the motion, which would allow doctors to test patients at their discretion and without necessarily asking consent."

The Department's reaction was echoed by Dr Samuel Galbraith, the Labour MP who is a member of the General Medical Council:

Dr Samuel Galbraith: "I think the legality of the decision is in question. A test that involves withdrawal of blood is an assault unless the patient has consented to it."

Professor Michael Adler: "It's a very sad day... Allowing potential patients to feel that any doctor sticking any needle into them may be testing them for the Aids virus without their consent will inevitably drive risk groups underground."

General Practitioners, surgeons, and anaesthetists maintain that they could be infected when they treat patients...

Dr Laurie Allan: "It is time to be realistic. I for one feel my life and those of my medical and nursing colleagues are more important than the future insurance and employment prospects of infected individuals."

Mr Brian Hopkinson: "Don't die of ignorance. Test the lot - before surgery at least."

Source:
http://archive.guardian.co.uk/Repository/ml.asp?Ref=R1VBLzE5ODcvMDcvMDMjQXIwMDEwMA==&Mode=Gif&Locale=english-skin-custom
Type: Guardian Article - Doctors to Test for Aids in Secret by Andrew Veitch, Medical Correspondent. 3rd July 1987
Location: UK
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1987, 17 November - David Owen Letter - Concern as to How Haemophiliac HIV Situation Occurred
In a letter to the Rt. Hon John Moore MP, then Secretary of State for Health, David Owen states the following:

"I am glad to see that you have made an ex-gratia payment for haemophiliacs who, as a result of transfusion, find themselves HIV positive."

"What concerns me however is how this situation has been allowed to occur. I note that in Hansard 393 on 22 January 1975, I said "I believe it is vitally important that the National Health Service should become self-sufficient as soon as practicable in the production of Factor VIII, including AHG concentrates"."

"On 22 April in a written answer I was even more explicit "l hope that the National Health Service can become self-sufficient in the production of all forms of Factor VIII within two or three years". The same answer was very much reiterated on 8 July (column 108).

"I would be grateful if you could let me know what happened to the extra money that was allocated to the regional transfusion centres, and why they did not become self-sufficient. I think I should in fairness warn you that I have it in mind to refer the issue to the Ombudsman on grounds of maladministration unless I receive a satisfactory explanation."

Source: http://www.taintedblood.info/tlfiles/David Owen Letter to John Moore 17 November 1987.pdf
Type: Letter dated 17th November 1987. David Owen writing to the Rt. Hon John Moore MP, then Secretary of State for Health
Location: UK
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1987, December - Plasma Testing Centres
Testing of HIV only becomes mandatory in US plasma centers in December 1987.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 768.
Type: Testing Development
Location: USA
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1987, 10 December - NANBH Factor VIII Trial Infrequently Treated Patients
In a trial of thirty previously untreated and infrequently treated patients, a 12-year-old haemophiliac boy with 11% factor VIII level is infected with Non-A Non-B Hepatitis from NHS factor VIII. Prior to the trial, he is a previously untreated patient PUP who has never received NHS or Commercial factor VIII. He has no previous hepatitis, and there was no serological evidence of past hepatitis B.

During the trial the young haemophiliac patient develops raised transaminase activity of 894 IU when prior to the study, he had levels of only 5 IU.

Note: This 12-year-old haemophiliac boy was deliberately allowed to acquire hepatitis for the sake of a trial. [Clinical diagnosis of hepatitis defined by raised aspartate and alanine transaminase activity of over 150 IU; at least four times the upper limit of normal.]

Source: Fletcher ML, Trowell JM, Craske J, Pavier K, Rizza CR. British Medical Journal, Vol 287, 10th December 1987.
Type: Trial - Infrequently Treated Patients
Location: UK
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1988 - Sunday Observer Timeline - UK Importing US Blood Products
UK reveals in 1988 that it is relying on American imports of blood products.
Source: Sunday Observer, April 16th 2006
http://observer.guardian.co.uk/focus/story/0,,1754868,00.html
Type: Press Timeline
Location: USA
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1988, January - BTSB - Armour Voluntarily Withdraws Heat-Treated Factor VIII
Armour voluntarily withdraws heat-treated factor VIII which is suspected of causing seroconversion in Canadian hemophiliacs.
Source: Lindsay Tribunal Report. Page 56 (Witness Testimony of Dr. Lawlor of BTSB)
Type: Development (Witness Testimony)
Location: USA
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1988 - Hyland - Solvent Detergent
In 1988, Hyland, was the first commercial manufacturer of Factor VIII in the USA to make concentrate using the solvent detergent process which is also purified by monoclonal antibody technology.
Source: Baxter Vaccines - Milestones
http://www.baxtervaccines.com/?node_id=1247
Report of the Tribunal of Inquiry: Lindsay Final, page 95:
http://www.taintedblood.info/tlfiles/Lindsay_Final.pdf
Type: Solvent Detergent Development
Location: USA
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1988, 27 January - BTSB - Armour Pharmaceutical Seeks an Indemnity from BTSB
Armour Pharmaceutical seeks an indemnity from BTSB, under which Armour cannot be held responsible by BTSB from all third party liability in respect of HIV, Hepatitis or other viral infection arising from the sale or use of factor concentrate, including, settlement costs, judgements and attorney's fees. All Armour trademarks and company names are to be removed from products supplied to the BTSB. This request for an indemnity arose because there was a move in the U.S. away from dry heated treatment, towards high purity product. Armour did not want to manufacture two different products.

Note: However, Armour does in fact continue to fractionate for the BTSB for some time.

Source: Lindsay Tribunal Report. Pages 56-7
Type: Request for Indemnity
Location: USA
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1988, February - David Owen, MP - Commissioner's Refusal to Investigate
Lord Owen first complained on behalf of a constituent to the Ombudsman's predecessor, the Parliamentary Commissioner for Administration, in 1988. He was then MP for Plymouth Devonport. He said health officials should have admitted to subsequent Ministers that the target of self-sufficiency could not be met without more money. But the Commissioner would not investigate, saying that parliamentary answers Dr Owen had given in 1975 did not suggest the risk of contamination had been a major factor.
Source: James Meikle, Health Correspondent, Guardian, Monday August 19, 2002
Type: National Press Article
Location: UK
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1988, 17 February - BTSB Board Meeting - Armour Indemnity - Serious Implications
The request from Armour for an indemnity from BTSB is discussed at a BTSB Board Meeting. The CEO explains that this request has very serious implications for the Board. The production of factor VIII will cease on 31st December 1988, after which the Board will be faced with a choice of Monoclate or pasteurised product. Both products have implications on the goal of self-sufficiency.

Product Liability Acts are about to become law.

Source: Lindsay Tribunal Report. Page 57
Type: Meeting
Location: USA
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1988, 1 March - Law - Product Liability
Under new legislation in Scotland, England and Wales, there is now protection for products supplied after 1st March 1988 - if the products do not reach a reasonable level of safety.
Source: The Consumer Protection Act 1987 (Modification) (Scotland) Order 2001 (Statutory Instrument 2001 No. 265) and the Consumer Protection Act 1987 (Modification) Order 2000 (Statutory Instrument 2000 No. 2771) (England and Wales).
Type: Legislation - Consumer Protection
Location: UK
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1988, 10 March - Macfarlane Trust Formed
The government agrees funding for the Macfarlane Trust charity to assist haemophiliacs who contracted HIV from contaminated blood products.
Source: http://www.dwp.gov.uk/advisers/z1/part1/thelaw3.asp
Additional Source: Sunday Observer, April 16th 2006
http://observer.guardian.co.uk/focus/story/0,,1754868,00.html
Type: MFT Formation - Observer Press Timeline
Location: UK
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1988, 11 March - Dr Perry - History of Factor VIII Batch 023110090 Associated with HIV Transmission
Batch History of FVIII Batch No. 023110090 Associated with HIV Transmission to SHS Haemophiliacs:

"This batch was associated with the transmission of HIV to approximately 15 Edinburgh Haemophiliacs. The details of these seroconversions have been extensively reported in the literature of Dr Ludlam."

"FVIII Batch No 023110090 was manufactured in November 1983 from plasma collected in the Autumn 1983. Clearly this preceded the availability or introduction of plasma donation testing or product treatments to inactivate HIV (eg heat treatment) either in the UK or internationally."

"Following the reports of product infectivity, attempts were made to identify the specific donation(s) which led to the product being infective. These were unsuccessful."

"Attached is a summary of the action taken by Dr McClelland and Dr Cuthbertson to effect a batch recall after initial notification by Dr Ludlam of seroconversions."

"Batch No 023110090 was in all other respects compliant with the product specification at that time and there were no notable events during the manufacturing process."

NOTE:

Please click the 'Find Related Entries' link below to see how this Timeline entry relates to the one for 10th October 1983 regarding the Medical Research Council (MRC) and what should be referred to as a controlled AIDS study of UK Haemophiliacs; the Edinburgh Haemophiliac Cohort; a study which we believe to have been entirely unethical.

Source: http://www.taintedblood.info/files/1440870483patients_allegedly_infected.pdf
Additional Source:
http://www.taintedblood.info/files/1440870671SNBTS_Response_to_Batch_023110090.pdf
Type: Scot Blood FOI Document - Summary of SNBTS Response to HIV Contamination of PFC Coagulation Factors. 11 March 1988.
Location: Scotland
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1988, April - BPL - Plasma Fractionation Plant, Elstree
In an effort to achieve self-sufficiency in blood products, BPL begin to construct a new and larger plasma fractionation plant at Elstree in Hertfordshire.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 33, page 924, paragraph 2.
Type: Development
Location: UK
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1988, May - BTSB - Mr. Keyes - Possible Product Liability Problems for Factor VIII
According to Mr Keyes, BTSB has 3 options:

  • To continue production of factor VIII
  • To change to monoclonal-derived factor VIII
  • To change to pasteurised product

It is also noted that continuing with factor VIII may present product liability problems.

Source: Lindsay Tribunal Report. Page 57
Type: Decision
Location: UK
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1988, 16 May - UK Haemophilia Reference Centre Directors - Virgin Patient Studies
In May 1988, against a background of recognised hazards in haemophilia therapy of HIV / AIDS infection, the UK Haemophilia Reference Centre Directors present a paper of 'recommendations' on the choice of therapeutic products for the treatment of haemophilia A, haemophilia B, and Von Willebrand disease:

"The strongest evidence on the magnitude of risk of viral transmission from any particular product is derived from 'Virgin Patient' (VP) studies, of which there have been relatively few. It is generally considered that at least 60 patients with uneventful follow-up are needed to satisfactorily prove safety at the 95% level of confidence. To our knowledge, no studies yet carried out have fulfilled this criterion." (page 2, paragraph 1)

Of the products available, or soon to be available in May 1988, there were 8 which were unlicensed and should only have been used on a 'named patient' basis, whilst another 8 products had already been used in 'virgin patient' studies.

Background: In complete contrast to these 'recommendations' for the continued use of plasma-derived factor VIII products, Hyland, in 1987, had already commenced human clinical trials of recombinant Factor VIII concentrate. (Source: Baxter Vaccines - Milestones. See below for link.)

Note: If the UK Haemophilia Centre Directors had genuinely wanted to protect their patients from further risk of viral infection, they would have overcome their fondness for 'virgin patient' studies and directed their need for unlicensed products toward early recombinant trials. After all, we know from a DHSS memorandum that the technology for genetically-engineered factor VIII was known about as early as September 1983.

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1988, July - Article EEC / UK - Crown Immunity and Product Liability
The EEC's strict Directive on Product Liability is introduced in the UK, along with a possible future Directive to remove Crown Immunity from NHS establishments.
Source: Quarterly information for hospitals served by the National Blood Service, March 2000, Issue 3, page 4.
http://www.blood.co.uk/pdfdocs/blood_matters_3.pdf
Type: Legislation
Location: UK
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1988, 25 July - DHSS Demerger
The Department of Health splits from the Department of Social Security. Kenneth Clarke is now Secretary of State for Health.
Source: Ministerial membership of DoH 1988-97
http://www.psr.keele.ac.uk/table/york/Health.html
Type: DHSS Demerger
Location: UK
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1988, September - Spiking - Studies in Living Subjects to Determine Adequacy of Viral Inactivation
In an article by Dr Margaret V. Ragni entitled, 'AIDS and Treatment of Hemophilia Patients', we learn that blood products had to be spiked with infectious virus in order to demonstrate safety or adequate inactivation - only these studies were clearly performed on living subjects...

"One problem in determining efficacy of any inactivation technique, however, was the inability of various isolation and serologic assays to detect HIV viral particles, viral antigen or antibody in concentrates."

"Thus, products had to be spiked with infectious virus and the log reduction of virus established for in vitro studies; for in vivo studies, patients had to be followed for HIV seroconversion, hepatitis B markers or transaminase elevation {for non-A, non-B hepatitis}, in order to demonstrate safety or adequate inactivation." (see page 180, PDF page 9)

NOTE:

We are dismayed to see such a direct reference to seroconversion as a result of these studies. This wording makes it abundantly clear that 'spiked' infectious product made its way through to being administered intravenously to haemophiliac patients:

"...patients had to be followed for HIV seroconversion"

In vivo:
We should also point out that according to Wikipedia, in vivo refers to experimentation using a whole, living organism as opposed to a partial or dead one. Animal testing and clinical trials are two forms of in vivo research. In vivo testing is often employed over in vitro (in the test tube) because it is better suited for observing the overall effects of an experiment on a living subject.

Source: http://www.penroseinquiry.org.uk/finalreport/pdf/LIT0010598.PDF
Additional source:
http://en.wikipedia.org/wiki/In_vivo
Type: Plasma Therapy and Transfusion Technology, Vol. 9, No.2: 173-191. AIDS and Treatment of Hemophilia Patients. Margaret V. Ragni, MD
Location: UK
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1988, September - The UK is Still Not Self-sufficient in Blood Products
The UK is still not self-sufficient in blood products owing to errors in estimating both the amount of plasma stockpiled and the net yield for factor VIII production at BPL, and can only be expected to become self-sufficient in another couple of years.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Statement. Taken from DOH Self-sufficiency Report
Location: UK
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1989, April - DoH / Haemophiliacs - Civil Action
A number of haemophiliacs begin a Civil Action against the Department of Health.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 33, page 940, paragraph 3.
Type: Civil Action
Location: UK
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1989, April - 2 Articles in Science 1989 - Choo, et al. - HCV
HCV (Hepatitis C Virus) is finally isolated and fully identified in April 1989.

Now it becomes clear that the vast majority of cases of NANBH were in fact due to HCV.

Source: Choo QL, Kuo G, Weiner AJ, Overby LR, Bradley DW, Houghton M. Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome. Science 1989;244:359-362
Type: Articles / Development
Location: USA
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1989, April - RTCs - Cross-Charging System is Put in Place
A system of cross-charging is put in place to encourage Regional Transfusion Centres (RTCs) to produce maximal amounts of plasma.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Development
Location: UK
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1989, June - Litigation Commences
The co-ordinated litigation commenced in June 89 with a hearing before the nominated judge, Mr Justice Ognall.
Source: HIV Haemophiliac Litigation, Advice on Settlement Document, Page 6, Point 5a
http://www.taintedblood.info/files/Advice%20on%20Settlement.pdf
Type: Legal Action
Location: UK
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1989, 3 July - ACVSB Advocates Further Study of Stored Haemophiliac Sera
In the Third Meeting of the Advisory Committee on the Virological Safety of Blood (ACVSB) in July 1989, we learn that a high-powered Government advisory committee wished to study and collect data on haemophiliacs.

Under the heading "Non-A Non-B Hepatitis" we read about the "need for a prospective study of post transfusion NANB in blood recipients or stored sera from haemophiliacs." (see page 2 of PDF link below)

Further on in the minutes, we read in handwritten notes:

"Data on Haemophiliacs to go to Dr A Rejman" (see page 4 of PDF link below).
Please note that Dr A Rejman was a Departmental haematologist, DHSS Med SEB/B.

"The Chiron test had been used in first time recipients of Factor 8Y. Preliminary results had shown no positives, while most recipients of earlier concentrates were Chiron positive. Further study of stored haemophiliac sera was advocated." (see page 6 of PDF below).

Note: It is worth remembering that the new Chiron HCV assay was being used much earlier than we previously thought, since these ACVSB minutes record the use of the HCV test in July 1989 - which in terms of HCV testing was considerably early.

LEGAL NOTE: We should point out that this non-consensual Hepatitis C testing was advocated by a Government advisory committee at a time when English and Welsh haemophiliacs were litigating against the Department. These vulnerable patients were kept in the dark about their HCV status by both the Department of Health and their treating consultants. It goes without saying that this knowledge would have impacted upon their cases. This is an example of material non-disclosure by the defence.

Source: Minutes of the Advisory Committee on the Virological Safety of Blood (ACVSB)
http://www.taintedblood.info/files/1440871803ACVSB_Meeting_3_Section_2.pdf
Type: ACVSB Minutes
Location: UK
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1989, 2 August - SNBTS Secretively Tests 146 Haemophiliacs for HCV
By 2nd August 1989 the SNBTS had evaluated the Ortho-Chiron ELISA Hepatitis C test kits.

Since the rediscovery of the once-missing ACVSB minutes, we now know that the SNBTS conducted HCV testing on 146 Haemophiliacs in Glasgow. They found that 92 (63%) of these haemophiliacs were positive (and repeat reactive) for HCV as early as August 1989. (see page 10 of PDF source below.)

These clinical trials of the new HCV test were conducted almost certainly without the knowledge of the haemophiliac community and were also carried out at an inopportune time - whilst English and Welsh Haemophiliacs were involved in the HIV Civil Litigation against the Department of Health which had been filed 3 months earlier; back in April 1989. It is clear that this should never have happened during litigation because the information garnered from Scotland impacted on our case in relation to Whitehall and the fact that it was allowed to occur amounts to nothing less than a gross miscarriage of justice on behalf of Government.

Note: It never ceases to amaze us as to the level of the apparent deception and duplicity directed at us by Government. It is clear from the minutes of the ACVSB, a high-powered committee whose responsibility it was to advise Ministers and the CMO, that they were fully aware that haemophiliacs had tested positive for Hepatitis C from as early as August 1989. This was well over one year before the waivers emerged - meaning that people with haemophilia were prohibited from suing in respect of HCV. It is now widely believed that these waivers were illegal.

Source: Advisory Committee on the Virological Safety of Blood, Volume 4:
http://www.taintedblood.info/files/1441217294ACVSB_Meeting_4_Section_5_Pg_10.pdf
Type: ACVSB File, Vol 4. Section 5, Page 10
Location: Scotland
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1989, 9 October - HCDO - Haemophilia Centre Directors Organisation - HCV Testing
Haemophilia Centre Directors' Organisation conduct HCV Testing in October 1989:

In the minutes of the Twenty-First meeting of the Haemophilia Centre Directors (HCDO) held on Monday 9th October 1989, it is clear that one of the doctors present, Dr Mortimer of the PHLS, was:

"willing to accept samples for Hepatitis C (HCV) testing. The Working Party would be looking at HCV testing in haemophiliacs." (see page 10 of PDF below).

Note: We find this appalling, especially since the date of the minutes is so early, i.e. October 1989. Many haemophiliacs (including two of the authors of this Timeline) were not informed of their HCV status until as many as 3 years later. This was also an extremely sensitive time, since persons with haemophilia in England and Wales were at least 6 months into the HIV Haemophilia Civil Litigation which had begun in April 1989.

From these minutes, we can determine that there was a drive amongst the HCDO Haemophilia Consultants to garner samples of UK Haemophiliacs' blood for early HCV testing. The report of the Independent Inquiry, chaired by Lord Archer of Sandwell, was satisfied that some patients were subjected to tests without knowledge of their purpose and without their consent. It is our belief that results were deliberately withheld from patients until after the signing of the 1991 waivers.

Source: Minutes of the 21st Meeting of the Haemophilia Centre Directors Organisation (HCDO). Monday 9th October 1989
http://www.taintedblood.info/files/1440767748October_1989_UKHCDO.pdf
Type: HCDO Minutes
Location: UK
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1989, 9 October - Dr. Rejman: Compensation Must be Sought in the Courts
In the Minutes of the 21st Meeting of the Haemophilia Centre Directors Organisation, on Monday, 9th October 1989, a discussion takes place about the ongoing Haemophilia HIV Litigation.

"Dr. Jones said that the Secretary of State, Regional Health Authorities and Committee for Safety of Medicines were being sued; doctors were not being sued. Mr Justice Ognall wished to proceed with the trial quickly."

"Broadly the claim was that the DHSS had failed to stop the use of imported concentrate and had been slow to produce heat-treated concentrates."

"Dr. Rejman, representing the Department of Health, stated that the Governments position was that there was no case for an out of court settlement and that compensation must be sought in the courts. ....He drew attention to the problem that might arise with the Committee on Safety of Medicines (CSM) if individual members could be sued as this might lead to great difficulty recruiting people who would be prepared to serve on the Committee. It was not a simple problem."

"Dr. Green asked Dr. Rejman if the case could be settled out-of-court if the claim against the CSM was withdrawn. Dr. Rejman was unable to answer this question but said it was the policy decision of different Governments that was being challenged."

Background: At first glance, the above suggests a classic example of the State influencing legal process. For example, there appears to be a dropping of the 'Duty of Care' allegation. In 1990, Justice Ognall made a 'statement of direction' in which he invited all parties to give 'anxious consideration' to the prospect of a compromise of the proceedings. This was leaked into the press on 26th June 1990. It should be pointed out that the plaintiffs were not made party to this statement until October 1990, 2 months later.

NOTE: It would appear that an 'agenda of compromise' was being proactively worked towards long before Justice Ognall's statement of direction was made public. This can be substantiated by the fact that the government's intransigent position was absolutely clear until it was confirmed that the Licensing Authority and Committee on Safety of Medicines (CSM) were to be left out of the proceedings. We know that as soon as the Department had confirmation from all parties that physicians and the CSM were going to be omitted from the allegations they conceded to an out-of-court compromised offer. It is clear to us now that the State and the medical profession influenced legal opinion and legal process.

Source: Minutes of the 21st Meeting of the Haemophilia Centre Directors Organisation (HCDO). Monday 9th October 1989:
http://www.taintedblood.info/files/1440767748October_1989_UKHCDO.pdf
Type: HCDO Minutes (see pps. 5-7)
Location: UK
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1989, 17 October - ACVSB - DHSS Receives Advice on Donor Screening from Dr Tuddenham
On 17th October 1989, the Mr J. Canavan of the DHSS received advice from Dr E.G.D. Tuddenham (Director, Haemostasis Research Group) that:

"...It may well be that screening donor blood by such an assay could reduce the transmission rate of non A, non B hepatitis in single donor products and in some pooled plasma derivatives."

Note:

This letter, which was sent to the Advisory Committee on the Virological Safety of Blood, constitutes official advice to the DHSS and as of this point in October 1989, the DHSS were deemed to have been advised that they were aware that screening of donor blood for single donor products (and some pooled plasma derivatives) could reduce transmission of non A, non B hepatitis (NANBH). This knowledge drew a clear legal line in the sand regarding the urgent need for implementation of HCV screening and use of the test.

Source: http://taintedblood.info/files/1244009173Tuddenham_Letter_to_DHSS_17_Oct_89.pdf
Type: ACVSB Minutes Fourth Meeting, October 1989.
Location: UK
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1989, 6 November - Mrs. Virginia Bottomley - Government Not Closed to Further MFT Funding
Mrs. Virginia Bottomley, Health Secretary: "The 10 million that the Government provided to set up the Macfarlane Trust was an ex-gratia payment and not compensation. I understand that the trust funds are not yet fully committed, but, as we made clear when the 10 million grant was announced, we shall not be closed to any representations about further funding which may be made at a later date."

"Some haemophiliacs who are HIV positive are now pursuing compensation through the courts and I am advised that this matter is now sub judice."

Source: Hansards Commons Answers, 6 November 1989, Column 449
http://www.publications.parliament.uk/pa/cm198889/cmhansrd/1989-11-06/Writtens-4.html#Writtens-4_dpthd1
Type: Government Statement: Ex-gratia Payment - Not Compensation / Sub judice
Location: UK
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1989, 14 November - Mr. Freeman MP - Ex-gratia Payment
Mr. Freeman: "The Government have already provided an ex-gratia payment of 10 million to set up the Macfarlane Trust to meet the special needs of haemophiliacs infected with HIV and their dependants. Claims for compensation are now being pursued through the courts and I am advised these matters are sub judice."
Source: Hansards Commons Answers. 14 November 1989, Column 192, Paragraph 5.
http://www.parliament.the-stationery-office.co.uk/pa/cm198889/cmhansrd/1989-11-14/Writtens-14.html#Writtens-14_wqn0
Type: Government Statement
Location: UK
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1989, 23 November - Dr David Owen - Failure of Parliamentary Ombudsman to Investigate
Lord Owen: "I have tried to persuade the parliamentary ombudsman to investigate this issue, but failed, for if ever there has been a clear and graphic case of maladministration, this must be it. We are all responsible".
Source: Commons Hansard, 23 November 1989, Column 272, Paragraph 2.
http://www.publications.parliament.uk/pa/cm198990/cmhansrd/1989-11-23/Debate-5.html#Debate-5_spnew2
Type: Commons Hansard
Location: UK
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1989, 23 November - Mr Kenneth Clarke - Sense of Shock at the Unique Position of Haemophiliacs
Mr Kenneth Clarke: "The Government share the universal sense of shock at the unique position of haemophiliacs who have been infected by the AIDS virus."
Source: Commons Hansard: Thursday 23 November 1989, Column 11.
http://www.publications.parliament.uk/pa/cm198990/cmhansrd/1989-11-23/Writtens-1.html#Writtens-1_spnew3
Type: Commons Hansard
Location: UK
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1989, 23 November - Dr David Owen - Others Infected by Viruses After NHS Treatment
In reference to Mr Kenneth Clarke's answer above, Dr. David Owen states: "I share that shock, but we must not let the Government get away with feeling that it is unique. Unfortunately, others have been infected by viruses as a result of being given treatment under the NHS. An example is infective hepatitis as a result of blood transfusions."
Source: Commons Hansard: Thursday 23 November 1989, Column 271
http://www.publications.parliament.uk/pa/cm198990/cmhansrd/1989-11-23/Debate-5.html#Debate-5_spnew2
Type: Commons Hansard 23/11/1989
Location: UK
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1990 - Article - Crown Immunity - NHS
Crown Immunity is soon to be removed from NHS establishments.
Source: Quarterly information for hospitals served by the National Blood Service, March 2000, Issue 3, page 4.
http://www.blood.co.uk/pdfdocs/blood_matters_3.pdf
Type: Crown Immunity Development
Location: UK
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1990, 17 January - Hepatitis C Screening Could Not Be Delayed Much Beyond FDA Approval
In an undated letter of the beginning of January 1990, Professor A. Zuckerman replies to Dr A. Rejman's letter of 7 December, 1989 concerning the professor's views on the justification for introducing hepatitis C virus testing for routine blood donor screening.

Professor Zuckerman, a member of the ACVSB Committee, looks forward to the Fifth Meeting of the Advisory Committee on the Virological Safety of Blood to be held on 17th January 1990, and states in his letter the following in relation to the introduction of the HCV Screening test:

Professor Zuckerman: "The projected cost of this screening test is, at least initially, very high, but considering the overall morbidity of chronic non-A non-B hepatitis (including apparently autoimmune liver disease and hepatocellular carcinoma), and litigation which would be indefensible, the introduction of screening could not be delayed much beyond FDA approval." (January 1990).

Source: http://www.scotblood.co.uk/site/pubdocs/19900117_acsvb_5th_meeting.pdf
Type: ACVSB Minutes. Fifth Meeting. 17th January 1990. (see pages 21 and 22 of pdf)
Location: UK
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1990, 17 January - Fate of Pre-existing Plasma Stocks ...To Avoid Repeat of HIV Story...
In a note to the Fifth Meeting of the Advisory Committee on the Virological Safety of Blood held on 17th January 1990 the following is stated:

HCV Testing:

"Majority view was that sufficient evidence of test positive/infectivity correlation to justify implementation - overriding factor was question of Product Liability."

"Evidence that the USA FDA will recommend implementation for cellular/single donor products but not for fractionated product - two independent sightings of this of this rumour (Rotblat and Thomas) but as yet unconfirmed. Importance of policy decision on fate of pre-existing plasma stocks before implementation of test to avoid repeat of HIV story."

Conclusion:

"No recommendation yet to ministers to implement test." (17th January 1990)

Source: http://www.scotblood.co.uk/site/pubdocs/19900117_acsvb_5th_meeting.pdf
Type: Type: ACVSB Minutes. Fifth Meeting. 17th January 1990. (see page 10 of pdf)
Location: UK
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1990, 29 January - Macfarlane Trust - Special Payments Trust Established
The Macfarlane (Special Payments) Trust is established on 29 January 1990, (partly out of funds provided by the Secretary of State).

The Government, in acknowledgement of its responsibilities for haemophiliacs who contracted HIV from contaminated blood products, makes an ex gratia payment to each one (or to the bereaved families) of 20,000 each.

Source: Department of Work and Pensions.
http://www.dwp.gov.uk/advisers/z1/part1/thelaw3.asp

Additional Source: Macfarlane Trust Funding Bid 2006-7, page 4, paragraphs 3-5.
Type: MFT (Special Payments)
Location: UK
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1990, 12 February - Haemophilia Centre Directors Discuss the HIV Litigation and HCV Testing Data
In the minutes of the Nineteenth Meeting of the AIDS Group of Haemophilia Centre Directors held at The Royal Free Hospital on 12th February 1990, a discussion takes place in relation to the ongoing Haemophilia HIV litigation and situation with HCV testing data. Dr Aronstam, of the Treloar Haemophilia Centre, Alton, is placed in a somewhat questionable position by his colleagues at this meeting.

"Dr Savidge raised the point that one member of the AIDS Group was acting as an expert on behalf of the Plaintiffs' and wondered whether it was acceptable for him to take part in the Group's discussions on Litigation and the Defence of the main statement of Claim. Dr Aronstam said he was the person referred to. He had not been asked to be a medical expert witness for the plaintiffs. If the group felt it was awkward for him to be present he would leave the meeting. He pointed out that some other directors were in a similar position and more might be in the future..."

"Dr Rejman said that the cases of Plaintiffs in the Wessex Region were being held back at present and would follow on after the lead cases had been considered. Dr Aronstam said he knew of at least two cases involving his patients which were going ahead as lead cases; it was news to him that Wessex cases were being put back."

"With regard to Health Authorities' Defence to the Re-amended Statement of Claim, Dr Savidge said that he had been using heat-treated Factor VIII as early as 1983 and he was trying to get the Defence's Statement amended as it said heat-treated factor VIII was not used until the end of 1984."

"Dr Lowe suggested that Dr Simpson's advice should be sought regarding the Haemophilia Society's request for information on hepatitis. Was hepatitis likely to be another item for which haemophiliacs would seek litigation and was it advisable for the Haemophilia Centre Directors to continue to collect data? Dr Simpson said it would not be advisable for the Directors to stop collecting data as they had already started to do so. Dr Hill pointed out that hepatitis was not a new thing; only the test was new. After further discussion, Dr Simpson agreed that the Haemophilia Society should not be given hepatitis data."

"Dr Lowe thought there was a difference between testing LFTs and testing for Hepatitis C and he wondered whether the patient's consent to testing should be sought Prof Bloom didn't see why permission needed to be asked for Hepatitis C tests as this was just another LFT. Dr Savidge said that patients were now becoming more and more conscious of what tests were, so he would advise caution at present."

Prof Preston quoted results presented at a recent meeting on prevalence of anti HCV in spouses of haemophiliacs. A figure of 20% was found which he thought was very worrying.

Note: The Joint Secretary of the 3 Defence Unions was present at this meeting, as was Dr A. Rejman, Senior Medical Officer (SMO), haematologist and DH Secretariat to the ACVSB.

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1990, (early) - BTSB - Haemophilia Patients Noticed to be Suffering from Hepatitis C
Some patients with haemophilia and other blood problems (who have used BTSB blood products) also noticed to be suffering from Hepatitis C.
Source: http://flag.blackened.net/revolt/ws/ws50_btsb.html
Type: Development
Location: UK
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1990, April - Dr Christine Lee - ACVSB Submission Paper - HCV in Haemophiliacs
During the Sixth Meeting of the ACVSB in April 1990, Dr Christine A. Lee (now Professor) submitted a paper in which she revealed:

"The use of the Ortho Hepatitis C assay kit has confirmed anti-HCV seropositivity in all haemophiliacs with well documented NANB hepatitis." (See pages 44-45 of PDF link below)

"Between 1978 and 1983 there have been 50 haemophiliac studies, 31 of them prospective." "The majority of multi-transfused haemophiliacs are shown to be positive for HCV antibody."

Note: We find it quite scandalous that this paper should be submitted in April 1990 to the ACVSB, a government advisory committee - right in the middle of the proceedings of the HIV Haemophilia Litigation. We should also draw attention to the use of the "Ortho Hepatitis C assay kit", the new HCV test, which demonstrates that genuine HCV testing was being conducted.

Source: Minutes of the Advisory Committee on the Virological Safety of Blood (ACVSB), Volume 6, section 5:
http://www.scotblood.co.uk/site/pubdocs/19900424_acsvb_6th_meeting.pdf
Type: ACVSB Minutes
Location: UK
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1990, 24 April - ACVSB on Spiking - Deliberate Addition of Significant Amounts of a Virus...
In a submission paper entitled "Guidelines for Validation of Virus Removal and Inactivation Procedures" for the Sixth meeting of the Advisory Committee on the Virological Safety of Blood on Tuesday 24th April 1990, the contentious issue of 'spiking' is discussed:

Point 3.3 the document states:

"The object of validation is to estimate quantitatively the level of virus clearance obtained along the various stages of purification and/or any viral inactivation stages. This will be achieved by the deliberate addition ("spiking") of significant amounts of a virus to the crude bulk to be purified and to different fractions obtained during the various purification stages and its removal during the subsequent stage of purification determined."

Point 4.2:

"The selection of viruses should take into account viruses which are known to be potential contaminants of the source material or of the production method. Thus, e.g. consideration should be given to validating the removal of hepatitis B virus, HIV, etc, from products derived from human blood."

Point 6: Limitations of the Validation:

"In vitro virus validation studies will be required for marketing authorization of a biological produced from animal or human sources. However, such studies have limitations and extrapolation from in vitro virus clearance/inactivation studies to virus safety in clinical use has not always been justified. Indeed confirmation that the product is virus-safe will be given only by long-term post-marketing clinical studies. Recipients of the product should be monitored clinically for seroconversion and for viral illnesses."

NOTE: This paper was included in the once-destroyed ACVSB minutes. It should be borne in mind that we were never meant to see these documents and those attending the meetings and providing submission papers would never have dreamt that we would be reading this today. The very purpose of the ACVSB was to provide advice to Ministers at a high-powered level - and by virtue of the exemptions provided for by Section 35 of the FOI Act, we most certainly would not have had sight of these minutes had a full set not resurfaced.

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1990, 5 May - Oklahoma Blood Institute
The first test for HCV (1.0) becomes available to USA blood centres on May 5, 1990. Oklahoma Blood Institute (OBI) immediately put this test into place.
Source: http://www.obi.org/bloodfacts/hepatitis.html
Type: Development
Location: USA
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1990, 26 June - Mr Justice Ognall Statement of Direction
Mr Justice Ognall makes a statement in chambers in which he invited the parties (defendants) to this litigation to give "anxious consideration" to the prospect of a compromise of these proceedings.

NB Plaintiffs were made party to this statement in October 2 months later (see entry 4th October).

Source: http://www.taintedblood.info/files/Harry%20Ognall.pdf
Type: Justice Ognall statement document
Location: UK
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1990, 31 July - Mr Justice Rougier - Prima Facie Case
"As to the facts, whilst stressing that I desire to express no opinion whatever on the ultimate outcome, the documents I have read which have already been disclosed to my mind are sufficient to show that the plaintiffs can raise a Prima Facie case if they can surmount the initial hurdle of showing that they are in the position to sue".
Source: Public Interest Immunity Hearing (22a of his judgement), Immunity Appeal Document, Page 36, Paragraph 2.
http://www.taintedblood.info/files/Immunity%20Appeal%20final.doc
Type: HIV Litigation
Location: UK
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1990, 5 August - Sir Donald Acheson, Chief Medical Officer - Kenneth Clarke
The Chief Medical Officer (CMO) gives advice to Kenneth Clarke to settle the litigation out of court to avoid the Government being forced to hand over sensitive documents revealing decisions taken when contaminated blood products were imported.
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1990, 5 August - Alf Morris - Chairman - Commons Committee on Disability
The delay caused by the legal argument also goes against assurances given by the Prime Minister that any legal action would be concluded as quickly as possible.

"It is a very serious matter if a department of state is acting in direct contradiction to the PM".

"She speaks for the government as a whole, and once she said that no obstacles will be put in the way that should be it".

Source: Sunday Times Article 5th August 1990
http://www.taintedblood.info/files/Sunday%20Times%20Article.JPG
Type: Political
Location: UK
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1990, 5 August - Margarette Driscoll - Sunday Times Reporter
Health authorities which are also being sued, are tiring of the complex and costly business of preparing their defence. The legal adviser to one authority last week privately admitted it was a symptom of "corporate madness"

A meeting of the authority representatives last month decided to ask the Department of Health to investigate ways of settling the matter out of court. If the action goes ahead, government legal cost will run into millions of pounds.

Source: Sunday Times Article 5th August 1990
http://www.taintedblood.info/files/Sunday%20Times%20Article.JPG
Type: Media
Location: UK
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1990, 7 September - Plaintiffs Counsel - Letter to Defendants
After hearing nothing from the defendants concerning Justice Ognall's statement (June 26th 1990) the Plaintiffs' Steering Committee wrote to the defendants on 7/9/90 asking for 80M to 90M.
Source: HIV Haemophiliac Litigation, Advice on Settlement Document, Settlement Negotiations, Page 7, Point 8b
http://www.taintedblood.info/files/Advice%20on%20Settlement.pdf
Type: Legal letter from Steering Committee
Location: UK
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1990, 20 September - Lord Justice Gibson
Lord Justice Gibson held that the haemophiliacs' right to proper presentation of their case overrode the right to public interest immunity, and that the plaintiffs had "a good arguable claim in law based upon common law negligence."

He said that it was very likely that the documents in question would contain material that would lend substantial weight to their claim: The plaintiffs need the documents for the proper presentation of their case in order for them to obtain the necessary expert evidence directed to the explanations for that failure which the documents will reveal. It seems to me to be necessary for the fair and proper disposal of the case that there should be known to both sides the actual grounds for the various decisions which led to the continued use of imported and other blood products capable of infecting a patient with HIV.

Source: Court Of Appeal Judgement Re: HIV Haemophiliacs Litigation, Court of Appeal (Civil Division), 20 September 1990.
Type: Legal Judgement
Location: UK
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1990, 20 September - HIV Litigation - Counsel Opinion - Duty of Care
E LEGAL ISSUES (2) DUTY OF CARE

28. "In the tort of negligence it is necessary to establish that there is a duty of care owed by the defendant to the plaintiff, a breach of that duty, and the causation by the breach of damage. In order to show that there was a duty of care it is necessary to show that there was sufficient proximity between the parties, and that it is just and reasonable to impose a duty of care."

"Furthermore, there is no duty of care owed for policy decisions made by the government unless they are shown to be unreasonable and it is strongly arguable that there is no duty of care for many decisions made by the government. These issues where helpfully ventilated before the court of Appeal in September 1990 when the plaintiffs succeeded in obtaining documents where public interest immunity was claimed."

Source: Haemophiliac HIV Litigation, Advice on Settlement Document, Dated 12/12/90, Page 15, point 22, (E Legal Issues (2) Duty of Care)
http://www.taintedblood.info/files/Advice%20on%20Settlement.pdf
Type: Legal Opinion from the Advice on Settlement Document - HIV Litigation - Ref. Duty of Care
Location: UK
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1990, 21 September - Hariett Harman - Ministers Knowingly Put Lives at Risk to Penny-Pinch on NHS
In a Guardian article entitled: "Appeal court backs HIV blood victims" on Friday, 21st September, 1990, the following is stated:

"Harriet Harman, Labour's health spokeswoman, claimed that the Government was concerned that if official papers were read out in open court the public would see that ministers had knowingly put lives at risk in order to penny-pinch on the NHS."

NOTE: Harriet Harman's claim is in direct contrast to the obvious implications of the following extract (regarding Kenneth Clarke) from the Scotsman on the same day in 1990:

"The Health Secretary, Kenneth Clarke, tried to insist that to the best of his knowledge the papers contained nothing that could help the claimants. But that begs the question why his department should then be so keen to keep them secret."

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1990, 21 September - Lord Justice Bingham - The Tragedy Was Avoidable ...
In an article in the Courier and Advertiser on Friday, 21 September, 1990 we learn that Lord Justice Bingham believed that the haemophiliac HIV / AIDS tragedy was largely avoidable if different measures had been taken:

Lord Justice Bingham:

"The tragedy was avoidable in the sense that, had different measures been taken in the 1970s and early 1980s, it could, at least in large measure, have been prevented."

Source: http://www.slowlyslowlycatchymonkey.com/Haemophiliacs_Can_See_Documents.pdf
Type: Press Article - Haemophiliacs can see documents about Aids. 21 September 1990.
Location: UK
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1990, 3 October - Department of Health - Legal Response Letter
The DoH rejected the possibility of settlement and suggested that the needs of the haemophiliacs should be met through the Macfarlane Trust
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, dated 12/12/90
http://www.taintedblood.info/files/Advice%20on%20Settlement.pdf
Type: HIV Litigation
Location: UK
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1990, 10 October - Plaintiffs Counsel - Letter to Department of Health
Steering committee wrote to the DoH asking for 55M to 60M. This was rejected by the department, as being totally out of the question. It became clear that no settlement could be reached except on the following terms.

1. DoH would not put forward any sum in settlement, but indicated it should be in the region of 30M.

2. All plaintiffs would have to settle, or there would be no settlement for any of them.

3. If and when the Department decide to settle, a settlement would have to take place quickly.

Source: Haemophiliac HIV Litigation, Advice on Settlement Document, dated 12/12/90
http://www.taintedblood.info/files/Advice%20on%20Settlement.pdf
Type: Legal Opinion HIV Litigation
Location: UK
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1990, 15 October - Kenneth Clarke - Health Secretary
"Ministers are, of course, and rightly, accountable to Parliament for their decisions on policies and priorities."
Source: Commons Hansard: 15 October, 1990, Column 661
http://www.publications.parliament.uk/pa/cm198990/cmhansrd/1990-10-15/Writtens-5.html#Writtens-5_spnew52
Type: Commons Hansard
Location: UK
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1990, 2 November - Government - Change of Minister
William Waldegrave is now Secretary of State for Health.
Source: Hansards - 2 October 1990. Additional source: Hansard 20 November 1990, Column 123
http://www.publications.parliament.uk/pa/cm199091/cmhansrd/1990-11-20/Orals-1.html
http://www.psr.keele.ac.uk/table/york/Health.html
Type: Political climate
Location: UK
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1990, 9 November - Steering Counsel - Letter to Department of Health
The sum of 42M was put forward with little enthusiasm. A response was asked for by 15th November 1990
Source: Haemophiliac HIV Litigation, Advice on Settlement Document, dated 12/12/90
http://www.taintedblood.info/files/Advice%20on%20Settlement.pdf
Type: Legal Opinion HIV Litigation
Location: UK
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1990, 28 November - Government - PM Appointed
John Major is appointed Prime Minister for the Conservatives on 28th November 1990.
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1990, 11 December - Mr Waldegrave - Health Minister - Liability in relation to Crown Immunity
Mr Waldegrave: "We believe that our case is legally strong and that the plaintiffs would not succeed in proving negligence on the part of the Department of Health. None the less the Government have always recognised the very special and tragic circumstances of the haemophiliacs infected by HIV and of their families."

"The Government have therefore agreed in principle to meet the Steering Committee's proposals."

"...the proposed settlement will require the formal approval of all individual plaintiffs, and in the case of minors, of the court,..."

Note:
It is interesting to note that the Health Minister is surprisingly confident concerning Department of Health liability in relation to Crown Immunity, especially considering that he had only been Minister for just over 1 month.

Source: Hansards: Commons Answers, 11 December, 1990, Column 365
http://www.publications.parliament.uk/pa/cm199091/cmhansrd/1990-12-11/Writtens-5.html#Writtens-5_spnew4
Type: Commons Hansard
Location: UK
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1991 - BTSB - Alert from an English Hospital over Anti-D Agent is Disregarded
The BTSB is alerted by an English hospital to the possibility that the six 1977 women cases may be linked to its "Anti-D" blood derived agent.

However, this alert is disregarded.

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1991 - Compensation Scheme
The Observer campaigns to extend compensation scheme to non-haemophiliacs affected similarly.
Source: Sunday Observer, April 16th 2006, press timeline
http://observer.guardian.co.uk/focus/story/0,,1754868,00.html
Type: National Press
Location: UK
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1991, 1 February - House of Commons Hansard Debate
On 1st February 1991 in a House of Commons debate regarding the proposed introduction of a National Health Service Compensation Bill, Mrs Barnes states:

"It is now academic whether there was negligence by the NHS. We all know that imported blood products were used some time after the possible dangers of those products were known."

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1991, 2 February - Mr Stephen Dorrell - BPL - Not Covered By Licensing Requirements
BPL is still not covered by the licensing requirements of the Medicines Act because of Crown Immunity.

However, some of its products and facilities are already so licensed and it will be seeking licences for other products, including high purity Factor VIII, under the arrangements leading to the removal of Crown Immunity. For many years the BPL has been inspected by the Medicines Inspectorate and its products have been tested by the National Institute of Biological Standards and Control, as are similar licensed pharmaceutical products.

Source: Commons Hansard, 19 February 1991, Column 86.
http://www.publications.parliament.uk/pa/cm199091/cmhansrd/1991-02-19/Writtens-2.html#Writtens-2_spnew12
Type: Commons Hansard
Location: UK
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1991, 25 February - FDA - Approval of Interferon-Alpha
The United States Food and Drug Administration (FDA) approves Interferon-Alpha to treat hepatitis C (HCV) on 25 February 1991.
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1991, 1 April - Mrs. Virginia Bottomley - End of Crown Immunity
Crown Immunity comes to an end as of 1 April 1991. The products of BPL are now within the scope of formal licensing arrangements of the Medicines Act.
Source: Commons Hansard, 7 November 1991, Column 254.
http://194.128.65.4/pa/cm199192/cmhansrd/1991-11-07/Writtens-8.html#Writtens-8_spnew32
Type: Commons Hansard
Location: UK
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1991, 1 April - Mr A Kerr MSP - Minister for Health, Scotland
The Crown immunity that was applied to all NHS bodies from the date of the creation of the NHS in 1948 is to be removed by means of the NHS and Community Care Act 1990 which comes into force on 1 April 1991.
Source: Mr A Kerr MSP, Minister for Health Scotland, Submission from Robert Mackie, Agenda Item 2, HC/S2/06/09/06, 18 April 2006.
http://www.taintedblood.info/files/1442173861Ag2MackieSubmission.pdf
Type: Submission Statement - Scottish Parliament
Location: Scotland / UK
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1991, 25 April - Michael Brooke, Plaintiffs' Counsel
So far as Plaintiffs who are pursuing medical negligence claims, the legal Aid Board is maintaining its position that it cannot waive the statutory charge. It is the intention that the matter should be put to Mr Justice Ognall at a hearing suggested for May 1st 1991, if we are unsuccessful, I am afraid there is nothing more that can be done and these plaintiffs will have to accept that if they pursue their medical negligence claims the charge will continue to apply to their settlement awards.
Source: Main Settlement Note from Junior Counsel
http://www.taintedblood.info/files/Settlement%20Note.pdf
Type: Legal Opinion HIV Litigation
Location: UK
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1991, 3 May - Macfarlane Trust Special Payment No 2 (MFTSP2)
The Macfarlane (Special Payments) (No. 2) Trust is established on 3 May 1991 (partly out of funds provided by the Secretary of State).

Further capital payments are made in settlement of potential litigation; these payments, which vary in amount according to the recipient's age and family status, total (by May 1993) about 44 million (including 316,000 paid to 158 people who had begun litigation proceedings).

Note: Over a third of the surviving registrants would have been classified as 'INFANTS' at the time of the 1991 settlement payments and, in consequence, received only 21,500 each.

Source: The Department of Work and Pensions
http://www.dwp.gov.uk/advisers/z1/part1/thelaw3.asp
Additional Source: Macfarlane Trust Funding Bid 2006-7, page 4, paragraphs 3-5.
Type: Special Payment No 2 (MFTSP2)
Location: UK
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1991, 10 June - Mr Waldegrave - Secretary of State for Health
"I welcome the announcement today in court of the conclusion of this litigation and the acceptance of the terms of a settlement by the overwhelming majority of those in England and Wales who were pursuing action. The Macfarlane Trust special payment [2] set up on May 3rd has already begun to make payments."
Source: Hansard Answers, June 10, 1991
http://www.publications.parliament.uk/pa/cm199091/cmhansrd/1991-06-10/Writtens-7.html#Writtens-7_spnew17
Type: Haemophilia Ex-gratia No-liability Recompense
Location: UK
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1991, September - Second-generation HCV Screening Assays
Second-generation HCV screening assays become widely used in the screening of donor blood in the UK.
Source: Self-sufficiency in Blood Products in England and Wales - A Chronology from 1973-1991. DOH (2006)
Type: Internal review document. Taken from DOH Self-sufficiency Report
Location: UK
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1992 - Hyland - Genetically Engineered Factor VIII
In 1992, Hyland markets the first genetically engineered FVIII concentrate.
Source: Baxter Vaccines - Milestones
http://www.baxtervaccines.com/?node_id=1247
Type: Development - Genetically Engineered FVIII
Location: USA
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1992, 17 February - Mr Waldegrave - Payments to Apply to Spouses, Partners and Children
Mr Waldegrave, Health Secretary:
"I have decided that the special provision already made for those with haemophilia and HIV is to be extended to those who have been infected with HIV as a result of National Health Service blood transfusion or tissue transfer in the United Kingdom. The payments will also apply to any of their spouses partners and children to whom their infection may have been passed on. The rates of payments are shown in the table. Similar help will be available throughout the United Kingdom."
Source: Hansard Answers, 17 February, 1992, Column 12
http://www.publications.parliament.uk/pa/cm199192/cmhansrd/1992-02-17/Writtens-2.html#Writtens-2_spnew8
Type: Hansard Answers
Location: UK
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1992, 9 April - Election - Change of minister
John Major continues as Prime Minister for the Conservatives.

The following day, Virginia Bottomley becomes Secretary of State for Health.

Source: http://www.number10.gov.uk/output/Page125.asp
Written Hansards. Additional source: Ministerial membership of DoH 1988-97
http://www.psr.keele.ac.uk/table/york/Health.html
Type: Political climate
Location: UK
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1992, 29 September - ACVSB Minutes - Parvovirus B19 Contamination of Factor Products
In the 14th meeting of the Advisory Committee on the Virological Safety of Blood (ACVSB) in 1992, the Chairman, Dr J. S. Metters, stated that a paper had been prepared on the detection of Parvovirus B19 in blood products in order to seek a view on whether the advisory committee should consider the matter more carefully at a future meeting. (see 1st source below, page 5 of PDF)

Surprisingly, in discussion, there was no agreement as to the degree of risk B19 posed in fractionated blood products. It was stated that although Parvovirus B19 could be eliminated, that effective testing could only be done on single donations and not on pools.

Detection of Parvovirus B19 in Blood Products:
In an Edinburgh study conducted over 3 months, the DNA of Parvovirus B19 "was detected in two-thirds (18 out of 27) separate batches of non heat-treated factor VIII and IX concentrate manufactured from plasma donations unscreened for B19 DNA."

"Dry heat treatment of 8OC for 72 hours reduced but did NOT always eliminate detectable B19 from factor VIII concentrates, consistent with recent observations that current methods of viral inactivation during blood product manufacture are insufficient to entirely eliminate B19 infectivity." (see 2nd source below, page 3 of PDF.)

There is convincing serological evidence for transmission of B19 by non-heat treated factor VIII and prothrombin complex concentrates. In one study, serological testing of haemophiliacs found elevated rates of Parvovirus B19 infection in recipients of dry or steam-treated Factor VIII.

"The frequency of PCR-positive donations detected in the above study (1/3300 donations) indicates that B19 might frequently contaminate blood products where pools of 3,000-10,000 plasma donations are used as raw material in the manufacturing process."

NOTE: It is horrifying to learn that another pathogen, Parvovirus B19, made its way into our factor concentrates in the 1980s and early 1990s. We pose the question: How many people with bleeding disorders were exposed to Parvovirus in this period?

Top
1993 - National Hemophilia Foundation - Defendant in Class-Action
The National Hemophilia Foundation is the 5th defendant in the Chicago Class-action lawsuit on behalf of all U.S. hemophiliacs who acquired the AIDS or HIV from factor concentrates.

The National Hemophilia Foundation is said to have been too financially dependent on the plasma companies to have been an effective advocate for hemophiliacs. The foundation denies this, insisting that it believes the products' benefits outweigh the risks.

Source: ON THE TRAIL OF TAINTED, Donna Shaw, INQUIRER STAFF WRITER, Philadelphia Inquirer
FINAL Section: EDITORIAL REVIEW & OPINION Page: E01, SUNDAY April 16, 1995
http://hcvets.com//data/transmission_methods/published_articles/philadelphia_inquirer.htm
Type: Legal Action
Location: USA
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1993, 29 March - Eileen Trust Formed
The Eileen Trust is established out of funds provided by the Secretary of State to support people who have become HIV positive because of NHS treatment, transfusions or needlestick injury.
Source: Department of Work and Pensions, 1.3 Exempt payments (d)
http://www.dwp.gov.uk/advisers/z1/part1/thelaw3.asp
Additional Source, Patient UK, Ref. Eileen Trust
http://www.patient.co.uk/showdoc/26739097/
Type: Trust Formed
Location: UK
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1993, 1 April - National Blood Authority - Creation
The National Blood Authority is created in April 1993.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 33, page 923.
Type: DoH Statement
Location: UK
Top
1993, July - Institute of Medicine
The Secretary of Health and Human Services asks the Institute of Medicine to review the events of the early 1980s relating to the transmission of HIV through the US blood supply.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 739.
Type: Request for review
Location: USA
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1993, July - Institute of Medicine Committee (Founded)
The Institute of Medicine appoints a special committee to Study HIV Transmission through Blood and Blood Products. The Institute of Medicine Committee is composed of experts in various disciplines throughout the USA. The Committee investigates for 2 years.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 739.
Type: Committee is formed
Location: USA
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1993, October - First US Litigation (MDL 986) - Consolidation of 13 Cases
The Judicial Panel on Multidistrict Litigation consolidates 13 hemophilia cases before the Honorable Judge John F. Grady of the United States District Court for the Northern District of Illinois, Chicago.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 783, paragraph 1.
Type: USA Litigation
Location: USA
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1993, 6 November - NIBSC Batch-Testing Of All Blood Products Released for Use in the UK
On Saturday, 6 November 1993, an article in The Scotsman entitled "Assurance After AIDS Contamination Scare" reveals a surprising statement that NIBSC batch-tested all blood products released for use in the UK, yet found no contamination with HIV...

A statement from the Department of Health said:

"The National Institute for Biological Standards & Control have batch-tested all blood products released for use in this country including those from IMMUNO. No HIV contamination has been found in any products authorised for release by the NIBSC."

NOTE:

If no HIV contamination was found in the products authorised for release by NIBSC ~ which from the mention of Immuno clearly included imported products ~ how was it possible that 1,200+ UK haemophiliacs became HIV positive which led to the deaths of over 900 of them?

Legal Note: Should the batch release certificates ever be disclosed by NIBSC to our solicitors, we dare say that NIBSC could be held liable for releasing contaminated products which were batch-tested and deemed safe. We believe Crown Immunity will be of little use as a defence since the products being tested included imported commercial concentrates. The very fact that these were not manufactured in the UK from 'altruistically' donated blood weakens the aegis of Crown Exemption that applied to all NHS bodies and premises until 1st April 1991. NIBSC may well find that the provisions of the Medicines Act are, in fact, binding on them in this case.

Source: http://www.taintedblood.info/files/1440871521AIDS_Press_Cutting_061193.pdf
Type: Press Article. The Scotsman. Assurance After AIDS Contamination Scare. 6th November 1993
Location: UK
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1994 - BTSB - Records of Hep C Positive Donors Examined - Anti-D Found to be Contaminated
The records of 15 Hepatitis C positive donors are examined. 13 are found to have been given the "Anti-D" agent. A connection is established and the BTSB announces that "Anti-D" was contaminated, and given, (unknowingly), to women about to give birth.
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1994 - Recombinant - First Licence
Recombinant Factor VIII is licensed for the first time for use within the UK.
Source: The Haemophilia Society, Fact Sheet, April 2004
http://www.haemophilia.org.uk/UserFiles/Fact%20sheets/recombinant%20headed.pdf
Type: License for Recombinant
Location: UK
Top
1995 - B19 Parvovirus - CPMP
In 1995 the Committee on Proprietary Medicinal Products (CPMP) encourages the development and introduction of steps to inactivate non-enveloped viruses, including Parvovirus B19.
Source: CPMP Note for Guidance on Plasma-Derived Medicinal Products, CPMP/BWP/269/95
http://www.emea.eu.int/pdfs/human/bwp/408000en.pdf
Type: Guidance Note
Location: UK
Top
1995, 5 July - Government - Change of Minister
Stephen Dorrell is Secretary of State for Health
Source: Ministerial membership of DoH 1988-97
http://www.psr.keele.ac.uk/table/york/Health.html
Type: Political climate
Location: UK
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1995, 13 July - Institute of Medicine Committee Report
The Committee publishes a report in which it examines events relating to donor screening, communicating information about risk to both physicians and patients, inactivating viruses in blood products, recalls, surrogate testing, and informing transfusion recipients of contaminated blood and blood products.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chapter 27, Page 739.
Type: Publication of Report
Location: USA
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1996, 28 March - Professor Dusheiko: "No Concerted Attempt to Introduce Heat Treated Products"
In an expert report in 1996, Prof. Geoffrey Dusheiko, hepatologist at the Royal Free Hospital, London, states:
"There was no concerted attempt to introduce heat treated products, even though studies in animals had suggested that heat treatment could be effective."
Type: Expert Report
Location: UK
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1996, April - Variant Creutzfeldt-Jakob Disease (vCJD) - First Documented
A new disease, vCJD, is first described and documented in April 1996. The first cases of Variant CJD (vCJD) actually appeared in 1995, but it was not until 1996 that the new variant of CJD was recognised.
Source: Lancet 1996: 347: 921- 25. A new variant of Creutzfeldt-Jakob disease in the UK
http://www.cjd.ed.ac.uk/lancet.htm
Department of Health. CJD
http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/CJD/fs/en
Type: Lancet Article - Development
Location: UK
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1996, 27 July - Clare Dyer, Legal Correspondent - Human Growth Hormone / CJD
In the first compensation claim over a pharmaceutical product over deaths from CJD to succeed in the British courts, Mr Justice Morland rules that the two bodies, Medical Research council (MRC) and the Department of Health were negligent in not passing on concerns raised by scientists that would probably have led to the human growth hormone treatment's suspension from July 1977.

Mr Justice Morland stated that the Scientific Steering Committee overseeing the manufacture of the hormone were told, the Clinicians' Committee is "deliberately kept in the dark".

Source: Clare Dyer, Legal Correspondent, British Medical Journal, 1996:313:185 (27 July)
http://bmj.bmjjournals.com/cgi/content/full/313/7051/185?
Type: BMJ Article - Legal - CJD
Location: UK
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1996, December - CDC
By the end of December 1996, the CDC compiled data reports that there are now 4,674 US hemophiliacs and 8,261 US recipients of blood transfusions who have contracted AIDS.
Source: Krever Commission Report (1997), Vol 3, Part IV, Chapter 27, Page 738.
Type: Data (CDC)
Location: USA
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1997, 1 May - General Election - Change of Minister
There is now a Labour Government with Tony Blair as Prime Minister.
2 days later, Frank Dobson becomes Secretary of State for Health.
Source: Ministerial membership of DoH 1988-97
http://www.psr.keele.ac.uk/table/york/Health.html
Type: Political climate
Location: UK
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1997, 8 May - First US Litigation - MDL 986 - Conclusion
Judge Grady gives his final approval to the settlement, marking the conclusion of the original US class action for US haemophiliacs: "Factor VIII or IX Concentrate Blood Products Liability Litigation".
Source: Krever Commission Report (1997), Vol 3, Part IV, Chap. 27, page 784, paragraph 2.
Type: Legal Action - Conclusion
Location: USA
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1998, February - HM Government
Government announces Recombinant Factor is to be made available in the UK for all children under 16 or all previously untreated patients (PUPs).
Source: Haemophilia Society, Fact Sheet, April 2004
http://www.haemophilia.org.uk/UserFiles/Fact%20sheets/recombinant%20headed.pdf
Type: Announcement
Location: UK
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1998, 30 May - Clare Dyer, Legal Correspondent - BMJ - Growth Hormone / CJD
Mr Justice Morland, the judge handling the litigation, ruled in 1996 that the Medical Research Council (MRC), which ran the growth hormone programme from 1959, was negligent from 1 July 1977 in failing to pass on warnings from scientists that the hormone could be contaminated by the infective agent for CJD.

That ruling resulted in compensation in 8 cases in which treatment had started after that date. Two other cases in which treatment was finished before that date were ineligible for compensation.

Source: British Medical Journal 1998:316:1625 ( 30 May )
http://bmj.bmjjournals.com/cgi/content/full/316/7145/1625/i
Type: BMJ Article - Legal CJD
Location: UK
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1998, 27 June - Clare Dyer, Legal Correspondent - BMJ - Fear of CJD
The Judge said that the psychological illnesses experienced by the 6 people granted the awards were not caused by irrational fears. They were due to "rational fears" about one day "succumbing to a ghastly lingering death from Creutzfeldt-Jakob disease."

The Judge added:

"No amount of psychotherapy or counselling can obliterate the truth. Each plaintiff remains indefinitely at risk of [the disease], which is inevitably fatal and not subject to amelioration or treatment."

Source: British Medical Journal 1998:316:1929 (27 June)
http://www.bmj.com/cgi/content/extract/316/7149/1929
Type: BMJ Article - Legal CJD
Location: UK
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1999, 6 August - FDA - First Test for Parvovirus B19
The FDA approves the first diagnostic test for parvovirus B19 infection in August 1999.
The test, manufactured by MedImmune Inc./ Biotrin International, is an enzyme immunoassay which works by detecting the B19 virus IgM antibodies in human serum and plasma. The test will be helpful in diagnosing and managing parvovirus B19 infection.

The test is expected to be available commercially in the U.S. by 2001.

Source: FDA Approved Products Developed with Technologies from the NIH Intramural Research Program
http://ott.od.nih.gov/about_nih/fda_approved_products.html
Type: First Diagnostic Test - Parvovirus B19
Location: USA
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1999, 11 October - Change of Minister
Alan Milburn is Secretary of State for Health.
Source: Full List of HM Government, Weekly Information Bulletin: 20th November 1999
http://www.publications.parliament.uk/pa/cm199900/cmwib/wb991120/hmg.htm
Type: Political climate
Location: UK
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2000, April - Caroline Flint MP - Internal Investigation - Shredded Documents
An internal investigation is undertaken in April 2000 by the Department's Internal Audit following the discovery that documents relating to the Advisory Committee on the Virological Safety of Blood between 1989 and 1992 had been destroyed in error.
Source: Commons Hansard, 23 May 2006, Column 1742W
http://www.publications.parliament.uk/pa/cm200506/cmhansrd/cm060523/text/60523w0029.htm#06052520000281
Type: Commons Hansard Destroyed Documents (Blood Products)
Location: UK
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2000, 13 September - Parvovirus B19 - EMEA Workshop on Viral Safety - CPMP
The EMEA Workshop on Viral Safety states in a report that "Parvovirus B19 DNA can be detected in many plasma-derived medicinal products and in particular coagulation factors."

"Parvovirus B19 is difficult to inactivate, as it is resistant to many of the current inactivation techniques." Inactivation of the virus in coagulation factors by pasteurisation or heat treatment is only partly effective, or not effective at all. Filtration requires an extremely small pore size, and such filters have not been practical for blood products.

New inactivation techniques are in development. "Testing of plasma mini-pools and pools by NAT for parvovirus B19 DNA in order to reduce virus load on the manufacturing process can diminish product contamination and complement other safety measures."

Source: EMEA Workshop on Viral Safety, Report, CPMP/BWP/BPWG/4080/00
http://www.emea.eu.int/pdfs/human/bwp/408000en.pdf
Type: Report
Location: UK
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2001, 10 January - Government Compensation for vCJD - Mr Alan Milburn
Government compensation scheme announced at the weekend. To date, there have been 101 deaths from vCJD. The compensation payments for the first 250 cases will come out of a 55m trust fund. Trustees on the independent body are to be appointed by the Department of Health.

Accepting the compensation does not rule out the possibility of the Government being sued for negligence, if it is felt there could be a case to answer.

Mr Milburn said: "I hope that these payments go some way towards recognising the pain and trauma experienced by victims and their families.

"vCJD is a national and personal tragedy for those affected. It is right that the families receive this compensation," he added.

Source: http://www.bbc.co.uk/devon/news/102001/01/mcvey.shtml
Type: CJD BBC News
Location: UK
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2001, 29 February - Alan Milburn - Health Secretary - NHS Must Change
The long-term Medical Alliance in London on 29/1/01, "The culture of the health service has to change. The days of cover-ups have got to end. Where the system fails the lessons need to be learned. The days have gone when the NHS could act as a secret society. It cannot operate behind closed-doors; it cannot keep patients in the dark. It has to take patients into its confidence; it has to communicate the risks of treatments. It has to explore options for the patient, if things go wrong it needs to explain why. It needs to be quicker at saying sorry".
Source: Sunday Times Article 30 September 2001
Type: National Press
Location: UK
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2001, 5 February - Britain Sells nvCJD Blood to 11 Countries
In an article by James Meikle and Alex Bellos in the Guardian on 5th February 2001, the following was stated:

Blood products donated by three people who were later struck down with the human form of BSE have been sold to 11 countries. Thousands of patients worldwide, and an unknown number of haemophiliacs in Britain, might have received treatments with the products between 1996 and last year. The risk of infection - which health department officials insist is only theoretical - has now been closed off by restricting blood sources to the US.

BPL had informed appropriate regulatory bodies abroad that nvCJD patients had donated blood. It had also written to wholesalers in each country and had confirmation they had told their relevant ministries. "We have tried our very best", said a spokesman.

WHERE IT WENT:

  • Ireland: Polio vaccine - 83,500 doses
  • Brazil: Albumin - 44,864 vials, immunoglobulin 80 vials
  • Dubai: Albumin - 2,400 vials
  • India: Albumin - 953 vials
  • Turkey: Immunoglobulin - 840 vials
  • Brunei: Albumin - 400 vials
  • Egypt: Albumin - 144 vials
  • Morocco: Albumin - 100 vials
  • Oman: Immunoglobulin - 100 vials
  • Russia: Factor VIII - 23 vials
  • Singapore: Immunoglobulin - 3 vials
Source: CJD link to blood Britain sold abroad, Guardian, Monday 5th February 2001
http://www.guardian.co.uk/uk/2001/feb/05/bse.alexbellos
Type: Press Article
Location: UK
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2001, 14 February - Alan Milburn Health Secretary - vCJD - Interim Compensation
Health Secretary Alan Milburn has announced that families of the victims of the brain disease vCJD will receive 25,000 as an interim compensation payment.

The Phillips report into BSE criticised ministers and civil servants for failing to respond quickly enough to warnings that BSE in cattle could enter the food chain and infect humans.

He said: "This interim payment will be made as soon as possible and will begin a round of negotiations between the government's lawyers and lawyers of the families to put in place a no fault scheme of compensation for the families designed to compensate losses and to meet needs."

Source: http://news.bbc.co.uk/1/hi/health/1170268.stm
Type: Political CJD / BSE
Location: UK
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2001, 26 March - Landmark Legal Action - Mr Justice Burton - HCV Litigation
A landmark case, A vs. National Blood Authority, is brought by 114 people infected with HCV via contaminated blood. Mr Justice Burton rules compensation be paid by the National Blood Authority and Velindre NHS Trust.
Source: Hansard, 12 March 2002, Column 765
http://www.publications.parliament.uk/pa/ld200102/ldhansrd/vo020312/text/20312-25.htm
Additional Source: A vs. National Blood Authority
http://www.ipsofactoj.com/international/2001/Part03/int2001(3)-009.htm
Type: Legal Action (Hansard)
Location: UK
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2001, 26 March - Commencement of Anti-Hep C Screening by Country

On 18th November 1987, Chiron Corporation filed a priority application in the USA for a patent describing the cloning and characterization of Hepatitis C virus as the causative agent of Non-A, Non-B Hepatitis.

The development of HCV tests then followed, with Chiron developing an alliance with Ortho Clinical Diagnostics. Understandably, following these discoveries, time was required in order to validate and register the HCV assay globally.

However...

The following timetable shows when various countries commenced anti-Hep C screening in relation to the Ortho test evaluation and trials:

tr> tr> tr> tr> tr>
Nov 1989 Japan
Feb 1990 Australia
Mar 1990 France (1 March): Luxembourg (new donors only, 1 March)
Apr 1990 Finland (1 April all donations: partially started 1 February)
May 1990 USA
May 1990 Austria (2 May): Amsterdam (other Netherlands Centres later)
Jun 1990 Canada: Germany (by 1 July)
Jul 1990 Belgium (1 July)
Aug 1990 Switzerland (1 August)
Sep 1990 Luxembourg (all donors)
Oct 1990 Italy: (many centres)
Oct 1990 Spain: (all by 12 October, some earlier)
1990/91 Norway
Jan 1991 Sweden (legal requirement published 24 January to start as soon as possible)
Mar 1991 (not before Mar) Portugal (mandatory)
Mar 1991 (some earlier): Cyprus: Greece: Hungary: Iceland: Malta
Apr 1991 Netherlands (mandatory 1 April)
Jun 1991 Denmark
Aug 1991 Italy (balance)
Sep 1991 UK (1 September)
Sep/Oct 1991 Ireland

Note: It is clear that the United Kingdom were in no hurry to introduce anti-HCV screening. Indeed, they could be said to have deliberately procrastinated, making them the last-but-one country in this list to introduce screening. This is consistent with what the Science and Technology Select Committee Inquiry report referred to as an over-optimistic "wait and see" stance, instead of taking the maximum precautionary approach. It is also possible to learn more about what can only be described as procrastination and stalling of the introduction of HCV testing by reading Chapter 9 of the Penrose Preliminary Report.

Source: A and Others -v- National Blood Authority and Another QBD 26 Mar 2001
http://www.bailii.org/ew/cases/EWHC/QB/2001/446.html
Type: Court Ruling - Justice Burton Judgment
Location: UK
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2001, 26 March - Countries which Introduced Surrogate Testing

Surrogate testing involved the use of non-specific tests for the purpose of reducing the incidence of transfusion association NANB Hepatitis. It is notable that routine ALT (alanine aminotransferase) testing was in effect in West Germany from 1965.

Germany 1965 (ALT)
Italy 1970 (ALT)
USA September 1986 onwards (both)
Luxembourg October 1 1986
Mid 1987 (for new donors)
(ALT)
(Anti-HBc)
France 15 April 1988
3 October 1988
(ALT)
(anti-HBc)
Switzerland 1 June 1988 (ALT)
Malta Early 1989 (ALT)

"There was some partial routine ALT testing in certain centres in Austria, Belgium and Spain, from about 1987, and Queensland (alone of the Australian states) introduced compulsory ALT testing in about April 1989. Dr Hgman told the Council of Europe in 1987 that Sweden was to introduce anti-HBc testing for first time donors, but he explained in evidence that this was intended in fact as a supplementary Hepatitis B screening. No other countries, so far as is known, ever introduced either test."

Note: It is unsurprising that surrogate testing had not been introduced in the UK - something that the claimants alleged should have happened, especially in light of the fact that the USA introduced both ALT and anti-HBc from September 1986 onwards.

Source: A and Others -v- National Blood Authority and Another QBD 26 Mar 2001
http://www.bailii.org/ew/cases/EWHC/QB/2001/446.html
Type: Court Ruling - Justice Burton Judgment
Location: UK
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2001, 20 April - Dr F G Williams - WBS - HCV Litigation: Reason Minister Decides Not to Appeal
Dr F G Williams, Director of the Welsh Blood Service in a paper for a Velindre NHS Trust Board Meeting entitled "Effects of the Hepatitis C Litigation", includes mention of the reason why ministers decided not to appeal. Under point 9, Dr Williams writes:

"After careful consideration the Minister has decided not to appeal against this judgement. As the Consumer Protection Act was enacted as a direct result of the European Directive this would be taken to the European Court as final arbiter and, as stated previously, the European Directive was tighter in its wording then the Act in the United Kingdom."

Source: Dr F G Williams, Director, Welsh Blood Service, Minutes Paper for Velindre NHS Trust Board Meeting. 27 April 2001
Type: Minutes Paper - HCV Litigation: Decision Not to Appeal
Location: UK
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2001, 23 April - Lord Burlison - Health Minister - Government Decide Not to Appeal Against Judgment
Lord Burlison: "The Government have decided not to seek leave to appeal against the judgment. Although an appeal would have provided an opportunity to seek clarification on some aspects of the judgment that may have a bearing on the future liability of the National Health Service bodies, the Government did not wish to subject the claimants to a further period of uncertainty while an appeal was under way".

Note: The reason not to appeal was just the opposite. Any appeal would have gone straight to the European Court as final arbiter.

Source: Hansards Debate Official Report, Column 75-77
http://www.publications.parliament.uk/pa/ld200001/ldhansrd/vo010423/text/10423-13.htm#10423-13_para91
Type: Hansards Lords Debate - Hepatitis C
Location: UK
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2001, 23 April - Lord Morris - Reference to Vicky Vidler - Haemophiliacs were Human Guinea-pigs
In a House of Lords Hansard (23 April 2001) Lord Morris of Manchester states the following:

"That no public inquiry has yet been held into a medical disaster on this scale - leaving 95 per cent of patients with the devastating complications of two life-threatening viruses - is without precedent in the modern era. And it does nothing to assuage the anguish and anger of the victims and their dependants to hear Ministers saying that so grave a disaster is now best forgotten; that it is time to "draw a line" under what happened; and that the haemophilia community should "move on". Indeed, they regard such statements as offensive and bereft of any understanding of the extent of sorrow and grief in their small, closely-knit community as more and more of them become terminally ill and die of infection by unclean NHS blood products."

"Yet fortunately they are not without friends good and true, as I was reminded again this morning by a deeply well informed and very moving letter of support for them from Vicky Vidler, who chairs the Royal College of Nursing's Haemophilia Nurses' Association."

"In effect, people with haemophilia given NHS blood products in the 1970s were human guinea-pigs for a new form of treatment. The risks were not explained to them; and despite the scientific knowledge then available to Whitehall that hepatitis could be transmitted in blood, no warnings were given to enable haemophilia patients to make an informed choice."

Source: http://www.publications.parliament.uk/pa/ld200001/ldhansrd/vo010423/text/10423-13.htm#10423-13_para28
Type: Lords Hansard. 23rd April 2001 - Column 66.
Location: UK
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2001, 7 June - General Election
There is a second term of Labour and Tony Blair is still Prime Minister.
Source: Full List of HM Government as at 13 June 2001, Weekly Information Bulletin
http://www.publications.parliament.uk/pa/cm200102/cmwib/wb010623/hmg.htm
Type: Political climate
Location: UK
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2001, 30 September - Alan Milburn - Health Secretary - Impact of CJD
The National CJD Surveillance Unit has so far traced 22 patients but they have not been informed, under guidelines set by the Department of Health, this is under review at the moment. The article states that Alan Milburn the Health Secretary is thought to be deeply concerned about the impact on people of being told that they have been exposed to a disease for which there is no conclusive test or cure.

The Ministry for Health may be able to stop them donating blood or organs to the rest of the general public, but this will not stop the risk of this disease being spread to their family and close friends, who could at this very moment be nursing the patients back to health after their operation during which they needed to receive blood.

Source: Jonathan Leake, Science Editor, Sunday Times Article, 30 September 2001
Type: National Press
Location: UK
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2001, 9 November - Jacqui Smith - Health minister - High Court Decision / CPA
The recent decision by the High Court has no implications for anyone infected with hepatitis C before the Consumer Protection Act came into force in March 1988. This includes the vast majority of HAEMOPHILIACS who were probably infected before that date.
Source: Hansard Commons Answers, 9 November 2001, Column 470w.
http://www.publications.parliament.uk/pa/cm200102/cmhansrd/vo011109/text/11109w11.htm#11109w11.html_spnew5
Type: Statement
Location: UK
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2002, 25 February - Yvette Cooper - Need for CJD Infectivity Screening Test for Blood Donations
In a Commons Hansard of February 2002, Yvette Cooper responds to questions regarding the increased 'theoretical' risk of contracting CJD through blood transfusions:

Yvette Cooper: "We are supporting a number of avenues of research into a diagnostic test for CJD to enable a screening test to be developed for blood donations."

Yvette Cooper: "At the request of the panel, the Department has commissioned independent consultants to provide an updated review of the potential CJD infectivity of blood and blood products."

Note: We are concerned to read from these comments that after as long as 5 years, the Government have announced yet a further consultation into the risks from blood products with regard to CJD. (See link below for SEAC February 2007 Papers 97-5).
Source: http://www.publications.parliament.uk/pa/cm200102/cmhansrd/vo020225/text/20225w78.htm#20225w78.html_spnew1
Additional Source: SEAC Meeting Notes for 10th May 2007, see points 1, 2,7,11
http://www.seac.gov.uk/papers/97-5.pdf
Type: Commons Hansard 25 Feb 2002 : Column 976W
Location: UK
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2002, 11 June - Ms Hazel Blears, MP - Cryoprecipitate Disadvantages
"There are no plans to hold a public inquiry or to investigate haemophilia treatment practices in the 1970s."

"We understand that treatment with cryoprecipitate carried a number of disadvantages compared to pooled clotting factors."

"It required the patient to be treated in hospital"

Source: Hansards Health Answers, 11 June 2002, [56024] [56026]
http://www.publications.parliament.uk/pa/cm200102/cmhansrd/vo020611/text/20611w24.htm#20611w24.html_wqn1
Type: Hansards Written Answers
Location: UK
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2002, 19 August - Lord Owen - Private Office Papers Inexplicably Pulped
Lord Owen said that in 1988 he had been unable to give evidence of his personal view that the source of donors was unreliable because his private office papers had "for some inexplicable reason been pulped." But the decision for self-sufficiency was never made only to save money.
Source: James Meikle, Health Correspondent, Guardian, Monday August 19, 2002
Additional Source:
http://www.taintedblood.info/tlfiles/Lord Owen Papers Disposed Of.pdf
Type: Statement - Press Article
Location: UK
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2002, 19 August - Lord Owen - No Doubt the Government Hasn't Got a Leg to Stand On
"I have no wish to go to court, but I have no doubt whatsoever that if someone starts to take serious legal action, the Government hasn't got a leg to stand on."
Source: James Meikle, Health Correspondent, Guardian, Monday August 19, 2002
Type: Statement
Location: UK
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2002, 1 October - Hazel Blears MP - Parliamentary Under Secretary of State for Public Health
Since 1971 all products made in or imported to the UK for medicinal use, including clotting factors from the US, require a product licence under the Medicines Act 1968. Advice on the quality, safety and efficacy from the Committee on the Safety of Medicines is given to the Health Secretary, and this is the basis for any product licence. "It is therefore not the case that these products were, for their time, not the best products available."

Note: The text in bold above may not make sense immediately, due to the double negative, but we have double-checked the source letter and it is quoted here verbatim.

Source: Hazel Blears MP. Letter to Charles Clarke MP. 1 October 2002
Type: Political
Location: UK
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2003, 12 February - HM Government
Government announces it will be extending the roll-out of recombinant Factor products to adults in England. They allocate 88m over the following 3 years.
Source: Haemophilia Society, Fact Sheet, April 2004
http://www.haemophilia.org.uk/UserFiles/Fact%20sheets/recombinant%20headed.pdf
Type: Announcement
Location: UK
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2003, 27 February - Philip Dolan Scottish Haemophilia Group Forum
Hepatitis C records go "missing"

Vital information from the medical records of Haemophiliacs infected with contaminated blood has gone missing.

Philip Dolan, chairman of the Scottish National Group Forum (SHGF) stated "When they contacted the hospitals, some were told it would take a very long time, others eventually got their records but parts were missing, particularly between 1980 and 1985.

Mr Dolan refused to say whether he thought there had been a cover-up but said: "You can get a bit cynical about your records disappearing. If you (a hospital) make a mistake once or twice, fine, but if it gets done three times, you start to think again."

The Scottish Executive refused to comment on the allegations, saying it was a matter for individual NHS trusts. However, Mr Chisholm promised to investigate the claims of missing records.

Source: http://news.bbc.co.uk/1/hi/scotland/2802585.stm
Type: BBC News website
Location: UK
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2003, 10 April - Contingent Liability - MFT - Mr Hutton Written Answer
In a Written Answer by Mr Hutton of 10 April 2003, the following is stated in relation to 'Contingent Liability' and the funding by the Department of the Macfarlane Trust (MFT):

"The Government originally paid 42 million to a trust from which payments are made to haemophiliacs infected with HIV virus, following treatment by the NHS with infected blood products. The Department has agreed to pay to the TRUST any sums required to make payments if the funds already provided prove insufficient."

Background: We should point out that Mrs. Virginia Bottomley, former Health Secretary, had already made the following statement in November 1989: "I understand that the trust funds are not yet fully committed, but, as we made clear when the 10 million grant was announced, we shall not be closed to any representations about further funding which may be made at a later date." [Source: Verbatim quotation, Hansards Commons Answers, 6 November 1989, Column 449 ]

Note: We have to ask why the Macfarlane Trust continually struggles to balance their finances and why the Department have largely ignored the crux of the detailed MFT Funding Bid and the 2003 Long Term Review? If the Department need reminding of their responsibilities, then they need to read this Written Answer. We know that the Macfarlane Trust cannot meet their remit and are prevented from doing the work they have been charged to do under the terms of their Trust Deeds. So where is the extra funding that was promised by the DOH?

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2003, 14 April - Newcastle Journal - HCV Tests Kept Secret
Claims that hundreds of hospital patients were secretly tested for a killer disease and then kept in the dark for up to 6 years about the results are to be investigated by the GMC.

Lord Morris, president of the Haemophilia Society, said: "At the very least the Government has a moral responsibility to compensate these people. With every new piece of information that comes to light the need for a public inquiry increases."

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2003, 14 April - icNewcastle The Journal - Consent - Right to Refuse Permission for Tests
GMC guidelines state health professionals "must obtain consent before testing for a serious communicable disease. Some conditions, such as HIV, have serious social and financial, as well as medical, implications. In such cases, you must make sure that the patient is given appropriate information about the implications of the test, and appropriate time to consider and discuss them."

GMC guidelines state that even for the purposes of research, patients must be given full counselling and the right to refuse permission for the test.

Also, in cases where a patient is in denial about his or her illness, the GMC states that a doctor has a duty to disclose that information.

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2003, 6 May - Dr Charles Saunders - British Medical Association
"I think you have to accept the fact that things were done differently in the past"

A spokesman said: "We are looking into the issue of the way patients were treated for blood borne diseases."

"We will look at the complaints and if we have found that there is evidence of professional misconduct we can take it to a final public hearing."

Dr Charles Saunders, the chairman of the British Medical Association's Public Health Committee in Scotland, said it was a "very disturbing" story.

Source: http://news.bbc.co.uk/1/hi/scotland/3002495.stm
Type: BBC News website
Location: UK
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2003, 30 May - Canadian Red Cross - Dr Pierre Duplessis
The Canadian Red Cross pleads guilty to distributing blood tainted with HIV and hepatitis C in a health disaster that has killed more than 3,000 people. The organization, which distributed the blood in the 1980s, will pay a fine of just $4,000 for causing more than 1,000 Canadians to contract blood-borne HIV and as many as 20,000 to become infected with hepatitis C.

Canadian Red Cross Secretary General Dr. Pierre Duplessis issues a public apology via videotape which is played in the courtroom to survivors of the victims. It states: "[The] Canadian Red Cross Society is deeply sorry for the injury and death ... for the suffering caused to families and loved ones of those who were harmed."

Source: http://www.worldnetdaily.com/news/article.asp?ARTICLE_ID=44529
Type: Canadian Red Cross Apology and Fine
Location: Canada
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2003, 13 June - Change of Minister
John Reid is now Secretary of State for Health.
Source: Commons Hansard, 27 Oct 2003, Column 84
http://www.publications.parliament.uk/pa/cm200203/cmhansrd/vo031027/debtext/31027-23.htm#31027-23_spmin1
Type: Political climate
Location: UK
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2003, 4 July - Lord Warner - Fresh Frozen Plasma - Parvovirus B19
With reference to the safety of fresh frozen plasma (FFP), Lord Warner states:

"Virally inactivated pooled FFP is subjected to a single virus reduction step. Two viruses (hepatitis A and parvovirus) are not susceptible to this form of inactivation. It is also possible that a new virus could appear that is not susceptible to the inactivation treatment and could spread to those transfused via the pooling of many donations."

Source: House of Lords Written Hansard, 4 July 2003, Column WA152
http://www.publications.parliament.uk/pa/ld200203/ldhansrd/vo030704/text/30704w03.htm#30704w03_spnew2
Type: Written Hansard
Location: UK
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2003, 14 July - Coroline O'Doherty
TWO former senior blood bank officials are to stand trial accused of infecting women with hepatitis C in an unprecedented action which could have implications for other investigations into contaminated blood products.

Detectives from the National Bureau of Criminal Investigation arrested Dr Terry Walsh and Cecily Cunningham at their homes in Dublin yesterday, before bringing them before the district court on charges relating to the infection of seven named women between 1977 and 1992.

Source: RTE.ie News, PDA Edition, 23 July 2003
http://www.rte.ie/news/2003/0723/blood.html
Type: Press Article
Location: Republic of Ireland
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2003, 29 August - Government Financial Assistance Scheme
A financial assistance scheme is announced by HM Government for those infected with HCV.
Source: House of Lords Hansard, 11 December 2003, Column 925, paragraph 4.
http://www.publications.parliament.uk/pa/ld200304/ldhansrd/vo031211/text/31211-13.htm#31211-13_spnew2
Type: HM Government Announcement
Location: UK
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2003, 7 September - Sue Leonard - DHSS Study
Papers seen by The Sunday Times show doctors had linked cases of hepatitis C to specific brands of blood-clotting agents during a monitoring project in the 1970s.

The study, funded by what was then the Department of Health and Social Security (DHSS), found that 197 cases of hepatitis C were reported by haemophilia centre directors between 1974 and 1979.

Source: Sue Leonard, Sunday Times Scotland, 7 September 2003
Type: Press Article
Location: UK
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2003, 7 September - Dr John Craske - PHLS - Suspect Batch
In 1982, Dr John Craske, of the Public Health Laboratory Service (PHLS), recommends that the surveillance should continue:
"He thought it might be necessary to again ask for details of all patients who had received treatment with a particular "suspect batch"," the report said.
Source: Sue Leonard, Sunday Times Scotland, 7 September 2003
Type: Press Article
Location: UK
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2003, 7 September - Scotland on Sunday (Ian Johnston) - Foreknowledge of Hepatitis
NHS knew of lethal blood for nine years.

SCOTTISH haemophiliacs were given contaminated American blood for nine years after health service bosses first linked the tainted supplies to hepatitis, documents obtained by Scotland on Sunday reveal.

Although the damning papers show the NHS began recording cases of the deadly disease "associated" with the clotting agents as far back as 1974, patients in Scotland continued to be given the infected blood until 1983.

However, haemophiliacs said the 1982 report showed enough was known at that time and before to have raised serious concerns. Brian Adam, an SNP MSP who has been a vocal supporter of haemophiliacs, said the documents were "explosive stuff". He said he would ask the Health Committee of the Scottish Parliament to consider recalling some NHS staff who had given evidence.

"It significantly strengthens the case of the campaigners seeking a public inquiry," he said. "There is certainly prima facie evidence of a cover-up. I cannot accept that the health community did not know what was going on in the light of this."

Source: http://scotlandonsunday.scotsman.com/health.cfm?id=984822003
Type: National Press
Location: Scotland
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2003, 14 September - Haydn Lewis - Secretary, Haemophilia Wales
Scottish Health Minister, Malcolm Chisholm gave evidence to the Health Committee with reference to the Hepatitis C recompense scheme for NHS patients who became infected via blood products.

In defence of his decision to make ex gratia payments far short of the recommendations made by Lord Ross in the Expert Group Report, the minister stated several times that the amount he has suggested was based on the limitations of the health budget he has to spend.

Source: British Nursing News Archives, Monday, 29 September 2003, paragraph 8
http://www.haemophilia.org.uk/UserFiles/Campaign%20briefings/CHRONOLOGY%20August%202006.pdf
Type: Press Article, Scotland on Sunday
Location: Scotland / UK
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2003, 21 September - vCJD Notification - Lord Warner PQ Response
A patient notification exercise is commenced in England to alert recipients of plasma products of their possible increased risk of vCJD disease. This exercise is still in progress.
Top
2003, December - vCJD Notification Exercise - Lord Warner PQ Response
15 recipients who received whole blood products in England are notified (Dec. 2003) of their possible increased risk of vCJD disease.
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2003, December - Gullone et al v. Bayer - Multidistrict Litigation - MDL 986 93 C 7552
The United States Judicial Panel on Multidistrict Litigation (MDL) transfers the Second Generation cases of MDL 986 filed by Lieff Cabraser Heimann & Bernstein, LLP as part of "In re Factor VIII or IX Concentrate Blood Products Litigation".
Source: Multidistrict Litigation - MDL 986 93 C 7552
http://www.hemophilia-litigation.com/index.htm
Type: Legal Action
Location: USA
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2004 - Sunday Observer Timeline - UK HCV Patients - Payment
UK Patients infected with hepatitis C from contaminated blood to receive at least 20,000.
Source: Sunday Observer, April 16th 2006
http://observer.guardian.co.uk/focus/story/0,,1754868,00.html
Type: Press Timeline
Location: UK
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2004, 23 January - HM Government - Hepatitis C
It transpires that Widows are excluded from the ex gratia financial assistance scheme.
Source: House of Lords Hansard, 5 February, 2004, Column 800
http://www.publications.parliament.uk/pa/ld200304/ldhansrd/vo040205/text/40205-03.htm
Type: Announcement
Location: UK
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2004, 2 February - Dr. John Reid, MP - Health Secretary
"the NHS has been grossly underfunded over the past 50 years."
Source: Dr. John Reid, MP. BBC Radio 2, The Jeremy Vine Show. 2 February 2004.
Type: Quotation
Location: UK
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2004, 7 September - Health Protection Agency Colindale - vCJD Product Recall
The Health Protection Agency, Colindale, provides those responsible for tracing vCJD-implicated blood products with tables listing batch numbers of plasma products which have been manufactured in the UK by Bio Products Laboratory (BPL) and the Protein Fractionation Centre (PFC).

The World Federation of Hemophilia website refers to this as "a precautionary measure", "as there is no known case of transmission of vCJD by a plasma-derived treatment product and no one with hemophilia has been diagnosed with vCJD."

Source: vCJD and Plasma Products - Tables of vCJD implicated batch numbers, 7th September 2004
Health Protection Agency, Colindale
http://www.wfh.org/2/docs/Safety_Supply/Recall_BPL_Sept2004.pdf
WFH Product Recalls
http://www.wfh.org/2/9/9_2_Product_Recalls.htm
Type: Letter - vCJD Product Recall
Location: UK
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2004, 21 September - Announcement of vCJD-Implicated Batches
24 batches of Factor VIII and IX are administered to persons with haemophilia and the batches are later identified as containing the blood of donors who has been found to have vCJD. There is still no test for vCJD and some health professionals maintain that the risk from vCJD in blood products is only "theoretical".
Source: Hansard 28 October 2004, Column 1395
http://www.publications.parliament.uk/pa/ld200304/ldhansrd/vo041028/text/41028-01.htm
Type: Announcement of vCJD
Location: UK
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2005, 5 May - General Election
The Labour Party achieves a third consecutive term in power. Tony Blair is Prime Minister. The following day, Patricia Hewitt MP is appointed Secretary of State for Health.
Source: Full list of HM Government, Weekly Information Bulletin
http://www.publications.parliament.uk/pa/cm200506/cmwib/wb050521/hmg.htm
Type: Political Climate
Location: UK
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2006, 25 July - Canada - Hepatitis C Settlement
Thousands of Canadians who contracted Hepatitis C through tainted blood products before 1986 and after 1990 will now each collect anything between 468 and 140,500.
Source: Canadian Press. 25 July 2006.
http://www.canada.com/globaltv/national/story.html?id=b4b96bb3-6b8d-47cd-85d7-c37c322f690b
Type: Settlement Press Article
Location: Canada
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2005, 25 October - Lord Jenkin of Roding
The Right Honourable Lord Jenkin of Roding writes to Sir Nigel Crisp requesting a meeting to discuss record management within the Department of Health. (Ref. Missing 600 Documents.)
Top
2005, 17 November - Dr Charles RM Hay - UKHCDO - Funding for Recombinant 2006/7
In a letter to William Connon of the Department of Health, Dr. Charles RM Hay, Chairman of the UKHCDO, expresses concerns that if the funding for recombinant for the 2006-7 financial year is not forthcoming, then there is likely to be considerable patient protest, with multiple judicial reviews and other legal activity, that will inevitably cause complete chaos both for the Department of Health and for Haemophilia Centre Directors.

Dr Hay states that, "Many centre directors are already fighting a low grade guerrilla war with patient activists who want a hepatitis C enquiry and who are reporting their centre directors to the GMC and manipulating both newspapers and television."

Dr Hay also points out that BPL have cut back their production of plasma-derived factor VIII and other manufacturers have removed their plasma-derived factor VIII from the UK market altogether.

Source: Dr Charles RM Hay. Letter to William Connon, General Health Protection, Department of Health. 17 November 2005.
Type: Letter
Location: UK
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2005, 1 December - Sir Nigel Crisp - Destruction of Files - Inexperienced Member of Staff
Sir Nigel Crisp replies to Lord Jenkin's enquiry as to why documents recently requested under the Freedom of Information Act (FOI) pertaining to contaminated blood were shredded allegedly in the early 1990s. The letter describes how it was believed that an inexperienced member of staff mistakenly marked the files for destruction.
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2006 - Sunday Observer Timeline - Government Urged to Increase Financial Support
Trustees of the Macfarlane and Eileen Trusts urge the government to increase financial support to those patients still alive.
Source: Sunday Observer, April 16th 2006
http://observer.guardian.co.uk/focus/story/0,,1754868,00.html
Type: Press Timeline
Location: UK
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2006, 1 January - Goudemand et al. - Increase in Inhibitors with Recombinant
Goudemand et al., report in a study in France, that the development of inhibitors in patients receiving recombinant factor products has increased as much as 3 times over plasma-derived products.
Source:
http://www.bloodjournal.org/cgi/content/abstract/107/1/46
Type: Retrospective Study - Article - Blood Journal
Location: France
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2006, January - Voluntary Suspension - PFC - Protein Fractionation Centre
Following an inspection by the MHRA, shortcomings in quality assurance processes are noticed and consequently, production at the Protein Fractionation Centre at Liberton, Scotland, is voluntarily suspended.

The NHS in Scotland is now expected to have to obtain the required products from alternative sources.

Source: Scottish Executive News, 26 June 2006.
http://www.scotland.gov.uk/News/Releases/2006/06/26131748
Type: News Article
Location: Scotland
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2006 5 January - FNC Ruling - Factor VIII / IX Concentrate Blood Products Litigation
A U.S. Court grants the pharmaceuticals' motion to dismiss the claims of the United Kingdom plaintiffs on the grounds of Forum Non Conveniens (FNC). The Court finds that the United Kingdom is an adequate alternative forum, and that the public interests weighs in favour of the United Kingdom claims proceeding in the United Kingdom instead of in the United States.
Source: Lieff Cabraser Heimann & Bernstein, LLP.
http://www.hemophilia-litigation.com/update_20060100.htm
Type: Legal Ruling (FNC)
Location: USA
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2006, 21 January - Lancet - International Scientists Warn of Emerging Pathogens
A team of international scientists publish a report in the Lancet warning of the possible ongoing threat of new pathogens to persons with bleeding disorders.

The article, "Clinical Perspectives of Emerging Pathogens in Bleeding Disorders" refers to factor concentrates, (which are now deemed to be safe with regards viruses such as HBV, HCV and HIV), however, the scientists emphasise that emerging pathogens could pose a threat in the future, especially if they are resistant to methods of virus inactivation.

According to Jamie Siegel, MD, associate professor of medicine at Jefferson Medical College and Director of the Hemophilia Treatment Center at Thomas Jefferson University:

"There will always be emerging pathogens and we won't always know what they are. We know that these pathogens may be in the blood supply, and if we have a population dependent on plasma derived products, they are always at risk."
Source: Ludlam CA, Powderly WG, Bozzette S, Diamond M, Koerper MA, Kulkarni R, Ritchie B, Siegel J, Simmonds P, Stanley S, Tapper ML, von Depka M. Lancet. 2006 Jan 21:367(9506):252-61.
http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx?menuid=122&contentid=497
Type: Lancet Article
Location: UK
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2006, 27 February - Lord Warner - Destruction of 600 HIV Litigation Papers
Lord Warner (The Minister of State, Department of Health): "Officials at the Department of Health have established that these documents related to the minutes and papers of the Advisory Committee on the Virological Safety of Blood between 1989 and 1992. These papers were destroyed between July 1994 and March 1998. A decision, most probably made by an inexperienced member of staff, was responsible for the destruction of these files."

Note: It is odd to observe the explanation that these documents were destroyed by "an inexperienced member of staff" when the Government itself (House of Lords) admits just 3 months later that only staff of "Executive Officer Grade or above" (Payband IP2), would have had the authority to do this.

Source: House of Lords Written Hansard, 27 Feb 2006: Column WA26
http://www.parliament.the-stationery-office.co.uk/pa/ld199900/ldhansrd/pdvn/lds06/text/60227w08.htm#60227w08_sbhd2
Type: House of Lords Written Hansard
Location: UK
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2006, 27 February - Department of Health - Publication of Self-sufficiency Report
The Department of Health releases a report into Self Sufficiency in Blood Products in England and Wales, A Chronology from 1973 to 1991.

The report came out of the opinion held by Ministers that the infection of haemophiliacs could have been avoided had the United Kingdom achieved self-sufficiency in blood products; a policy Government initiated in 1975.

Note:
The review conveniently omits important correspondence between Government bodies in the timeframe 1973-79, and instead concentrates more on efforts to address the failings highlighted in the Medicines Inspectorate report of BPL Elstree, which, if they had been any normal business, would certainly have been closed down. However, due to Crown Immunity, the Government avoided the closure of BPL and they continued to process blood products in a condemned facility. The question must therefore be asked as to why this facility was allowed to fall into such disrepair?

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2006, 27 February - Press Statement - Review Published on Infected Blood Products
The Department of Health publishes a report into how patients were infected with Hepatitis C and HIV through contaminated blood in the 1970s and early 1980s.

The press release presents conclusions as fact rather than opinions, whereas the Department of Health report itself concludes that "The information gathered during this review has been at times contradictory and incomplete, but the following conclusions can be "inferred"."

Note: The report is a review which focuses upon "surviving" documents from 1973 (when a decision was made to pursue self-sufficiency for England and Wales) to 1991 (when a validated screening test for HCV was introduced in the UK).

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2006, 28 February - Haemophilia Society - Condemns Department of Health Self-sufficiency Report
The Haemophilia Society condemns the report by the Department of Health into self-sufficiency in blood products as "an attempt to gloss over the details of a medical disaster that left a generation of people with haemophilia infected with life-threatening viruses."

The following shortcomings are mentioned:

  • The report does not have a named author
  • There is no mention of what information was given to patients regarding the safety of products to enable them to give informed consent
  • The report fails to mention the use of UK prison blood in clotting factors
  • The report fails to explain why the phased redevelopment of the Government facility for producing blood products took a year to implement and why the laboratory was allowed to continue manufacturing whilst having been declared 'unfit' under the Medicines Act 1968.
Haemophilia Society Press Release Feb 06
Source: Haemophilia Society Press Release February 2006
Type: Press Release
Location: UK
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2006, 30 March - Lord Warner - Department of Health Notified of Fraud Against Skipton Fund
Lord Warner, the Minister of State for the Department of Health, states in answer to a question by Lord Morris of Manchester: "In January 2006, Department of Health officials were notified about a fraud against the Skipton Fund. Officials in the department and the NHS Counter Fraud and Security Management Services are working with the Skipton Fund to ensure that the necessary arrangements are in place to handle the administration of the scheme and prevent potential cases of maladministration."
Source: House of Lords Written Hansard, 30 March 2006, Column WA147
http://www.publications.parliament.uk/pa/ld200405/ldhansrd/pdvn/lds06/text/60330w05.htm#wa_st_32
Type: Written Hansard Ref. Skipton Fund
Location: UK
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2006, 19 April - Caroline Flint MP - Announcement of the Continuation of Recombinant For All
At a reception hosted by Lord Morris of Manchester in the House of Lords, the Minister of State for Public Health, Caroline Flint MP, announces in a speech that 'recombinant for all' will continue in 2006-7.

Note: The speech contains no mention of the 'behind-the-scenes' perspective of Dr Charles RM Hay, chairman of the UKHCDO, who in correspondence to William Connon, expresses fears of considerable patient protest and in particular, states that he hopes "DoH will look upon your bid for recombinant financing favourably, because the alternative is almost too awful to contemplate".

Source: The Haemophilia Society, Campaigns, Latest News
http://www.haemophilia.org.uk/index.php?content_id=46
Dr Charles RM Hay. Letter to William Connon, General Health Protection, Department of Health. 17 November 2005.
Type: Announcement - Political
Location: UK
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2006, 15 May - Lord Warner - Grade of Officer - Shredding of Documents
In answer to a question from Lord Morris regarding what grade of official can make an order for the shredding of documents within the Department of Health, Lord Warner states:

"Current guidance states that decisions on retention or destruction should be made by, "whoever has best knowledge of the subject matter. The reviewer should be in Payband IP2 (Executive Officer Grade) or above."

Departmental policy on records management also states that, "Line managers are responsible for ensuring that record keeping within their areas is consistent and meets Departmental standards.""

Source: House of Lords Written Hansard, 15 May 2006, Column WA5, [Ref. HL5511]
http://www.publications.parliament.uk/pa/ld199900/ldhansrd/pdvn/lds06/text/60515w02.htm#60515w02_sbhd0
Type: House of Lords Written Hansard
Location: UK
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2006, 23 May - Caroline Flint MP - Documents Destroyed In Error - Internal Investigation
Caroline Flint: "During the HIV litigation many papers were recalled, and following that we understand papers were not adequately archived and were unfortunately destroyed in error. Officials subsequently established during the hepatitis C litigation that documents relating to the Advisory Committee on the Virological Safety of Blood between 1989 and 1992 had been destroyed in error. Following this discovery, an internal investigation was undertaken in April 2000 by the Department's Internal Audit."

Note:
With regard to the "Hepatitis C Litigation", persons with haemophilia were excluded from these Consumer Protection Act (CPA) cases because the legal profession assumed that our hepatitis C infection occurred before product liability was absorbed into the Consumer Protection Act in 1987/88.

Source: Commons Hansard, 23 May 2006, Column 1742W
http://www.publications.parliament.uk/pa/cm200506/cmhansrd/cm060523/text/60523w0524.htm#06052520000281
Type: Commons Hansard - Shredded Documents (Blood Products)
Location: UK
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2006, 24 May - Lord Warner - Recovery of HIV Litigation Papers
"My Lords, we have established that a number of documents that have been disclosed by the department in the HIV and hepatitis C litigation were held by Blackett Hart & Pratt Solicitors. It agreed to return the papers to our solicitors, who are now considering them with other departmental officials. Advice has yet to be given to Ministers on the significance of the returned files."
Source: House of Lords Written Hansard, 24 May 2006: Column 825
http://www.publications.parliament.uk/pa/ld199900/ldhansrd/pdvn/lds06/text/60524-03.htm#60524-03_spnew8
Type: House of Lord - Written Hansard - Shredded Documents
Location: UK
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2006, 24 May - Lord Jenkin of Roding - 12 Lever-arch Files of Documents
"My Lords, the files that have turned up came from the archives of more than one firm of English solicitors. Given the substantial volume of documents passed to the department's solicitors - I am told that there are no fewer than 12 big lever-arch files and the fact that what they have is a small fraction of the material that has been held in solicitors' archives..."
Source: House of Lords Hansard, 24 May 2006: Column 826
http://www.publications.parliament.uk/pa/ld199900/ldhansrd/pdvn/lds06/text/60524-03.htm#60524-03_spnew9
Type: House of Lords - Written Hansard
Location: UK
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2006, 7 June - Confusion Over Total Amount Already Paid Via the Macfarlane & Eileen Trusts
In a Written Answer of Wednesday, 7 June 2006, with the subject heading HIV/AIDS (Blood Transfusions), there appears to be some confusion over the total amount already paid via the Macfarlane (MFT) and Eileen Trusts:
  • Pete Wishart (Perth & Perthshire North, Scottish National Party): To ask the Secretary of State for Health how much compensation has been paid by the UK Government to those who contracted HIV through blood transfusions. [74297]
  • Caroline Flint (then Minister of State for Public Health, DOH): Up to March 2006, the United Kingdom Government have distributed a total of 39,787,617 via the Macfarlane and Eileen Trusts, to those who contracted HIV infection from blood transfusions or from treatment with blood products.
Note: We have to take issue with the above use of the word 'compensation'. No 'compensation' has ever been paid - that would require an acceptance of liability as compensation schemes tend to arise in circumstances where responsibility has been admitted.

Background: We have to wonder whether the DOH are confused and ignorant as to how much the Trusts have received over the years. On 10th April 2003, Mr Hutton quoted 42 million as a total figure: "The Government originally paid 42 million to a trust from which payments are made to haemophiliacs infected with HIV virus...". Why then, over 3 years later, do we find a discrepancy of over 2 million?

Note: The Department goes to great pains to portray that they have every sympathy with our position, however, their SINCERITY is perhaps questionable when they appear to have no idea how much they've paid out and that they regard the matter of contaminated blood as having been dealt with legally; as demonstrated to us by their belief that the haemophilia community has received 'compensation'.

Source: http://www.publications.parliament.uk/pa/cm200506/cmhansrd/cm060607/text/60607w0022.htm#06060874005257
Additional Source: www.They Work For You.com:
http://www.theyworkforyou.com/wrans/?id=2006-06-07b.74297.h
Type: Hansard Written Answers, 7 Jun 2006 : Column 715W.
Location: UK
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2006, 16 June - Health Minister - Refusal of Public Inquiry
Andy Kerr, Health Minister Scotland, rules out the possibility of conducting a Public Inquiry into the infection of patients with hepatitis C in Scotland.

A judicial inquiry had been requested by a Holyrood committee to investigate how thousands of people contracted HCV from blood products in the 1970s and 80s.

"I do not believe a public inquiry would uncover any new information that is relevant to the causes of the infection of NHS patients " Health Minister, Andy Kerr.

Source: Lorna Martin, Sunday Observer (Scotland Edition), Sunday June 18, 2006
http://observer.guardian.co.uk/uk_news/story/0,,1800309,00.html
BBC News, Friday June 16, 2006
http://news.bbc.co.uk/1/hi/scotland/5087444.stm
Type: Announcement of Refusal
Location: Scotland
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2006, 22 June - Japanese Court Orders Payments in Blood Scandal
A court in Osaka, Japan this week ordered the Japanese government and 2 pharmaceuticals to compensate HCV patients who acquired the disease through contaminated blood products.

Of the 9 plaintiffs, 4 were awarded compensation by manufactures, and 5 received compensation from the government. The compensation awarded had a total value of GBP 1.2m (an average of 133,000 per plaintiff.)

Source: Associated Press, 21 June 2006
http://www.aegis.com/news/afp/2006/AF0608D0.html
Type: Associated Press
Location: Japan
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2006, 26 June - Closure of PFC - Protein Fractionation Centre, Scotland
The PFC at Liberton, Edinburgh, is deemed "no longer viable" following a strategic review of the plasma products manufacturing division of the SNBTS. Due to the move away from plasma-derived blood clotting factors and the risks of vCJD, plasma is to be obtained from sources outside of the UK.

Any required plasma products will probably need to be imported.

Source: Scottish Executive News, 26 June 2006.
http://www.scotland.gov.uk/News/Releases/2006/06/26131748
Type: News Article
Location: Scotland
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2006, 30 June - Aptivus / Tipranavir - Treatment Safety Alert
The FDA are notifying healthcare professionals of 14 serious reports of both fatal and non-fatal intracranial haemorrhage in patients receiving the medicine Aptivus (Tipranavir) co-administered with Ritonavir.
Source: Food and Drug Administration Notification
http://www.fda.gov/medwatch/safety/2006/safety06.htm#Aptivus
Type: FDA Treatment Warning
Location: USA
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2006, 26 July - Irish Government - Decision Not to Pursue Litigation
The Government of the Republic of Ireland decides not to pursue legal action against certain international pharmaceutical companies which supplied blood products tainted with HIV and HCV. This follows consultations with expert legal counsel both in the United States and Ireland regarding the likelihood of a successful lawsuit.

Note: This decision may not be entirely to do with the feasibility and strength of the case against the pharmaceuticals, it might well also be to do with the understandable desire to avoid drawing attention to the legal implications surrounding the unpropitious actions of various governments around the world in the whole tainted blood affair.

Source: Department of Health and Children. 26 July 2006.
http://www.dohc.ie/press/releases/2006/20060726.html
Type: Government Decision
Location: Republic of Ireland
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2006, 7 December - SEAC - Proposal to Anonymously Screen Blood with Prototype vCJD Test
In the Minutes of the 95th Meeting of the SEAC in 2006, it is clear that they wish to anonymously screen samples of donated blood using a prototype blood test. The discussion revolves around a test that can provide substantial data relatively quickly, but that the success of which will depend upon the performance of the prototype blood tests and they are used to confirm reactive samples from the initial screening tests. (Page 18)

Note: We have to wonder if our blood samples might have already been tested without our consent? We also wonder what pre-and post-test counselling provisions will be put in place, if any?

Source: http://www.seac.gov.uk/minutes/95.pdf
Type: Minutes - Draft Minutes of the 95th meeting of the Spongiform Encephalopathy Advisory Committee. 7th December 2006.
Location: UK
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2007, 12 February - Amorfix - Canada - New Blood Test for vCJD
Amorfix Life Sciences Ltd. announced today that it is presenting for the first time results from its Epitope Protection technology, a prototype commercial scale blood test for the diagnosis of variant Creutzfeldt-Jakob Disease, (EP-vCJD) at the Cambridge Health Institute's 11th Annual Conference on TSE Diseases in Baltimore, Maryland.

Dr. George Adams: "Our EP-vCJD" blood test is a major step forward because for the first time it allows for the rapid screening of tens of thousands of blood samples to determine how many people have been infected with vCJD and how many people are incubating the disease."

Dr. George Adams: "As Judge Krever noted in his report on Canada's HIV-AIDS blood testing, if transmission by blood transfusion is possible, then a blood transfusion service must act as if a disease is being spread through blood transfusions unless it has scientific proof it is not present. To date, four people in the United Kingdom have contracted vCJD by blood transfusion, with the latest case reported January 18, 2007. With our "EP-vCJD" test, we can finally determine the appropriate level of surveillance necessary to protect the blood supply from vCJD."

Source: http://www.amorfix.com/2007_02_12_CHI_Conf_2007.pdf
Type: Testing Development - vCJD Amorfix Life Sciences Ltd.
Location: Canada
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2007, 19 February - Lord Morris - The Archer Report will be Self-Standing
On Monday 19th February 2007, BBC News Scotland reported on Lord Morris as he explained why the Archer Independent Inquiry was being held. During the footage, Lord Morris made the following powerful statement about the Archer report:

Lord Morris: "I think you'll find that at the end of this Inquiry, that such is the standing of the people involved, that it's report will be self-standing, it's report itself, will be one of commanding authority that can't be dodged by anyone."
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2007, 10 May - DoH Seeks Advice from SEAC of Likely vCJD Infectivity of Plasma Products
In the Meeting Papers for the 97th meeting of SEAC, we read that the Department of Health have sought advice on the future assessment of likely vCJD infectivity associated with plasma products.

ADVICE SOUGHT FROM THE COMMITTEE:

Point 7:
The Department of Health requests that the committee assesses, at a future meeting, the likely removal of infectivity during the process of producing plasma products from blood contaminated with the vCJD agent and considers the likely time period when infections from plasma products, if they took place, may have occurred.

Point 11:
The committee is requested to agree to assess, at SEAC 98 [on 20th July 2007], the likely infectivity of, and possible timing of infections from, plasma products derived from blood contaminated with the vCJD agent and produce a position statement.

Note: We are curious to read of this instruction, especially since in the earlier minutes of 95th SEAC meeting, we learn of a proposal to 'anonymously' screen samples of donated blood using prototype blood tests which they believe may also provide substantial data relatively quickly.

Is there a vCJD test? Persons with haemophilia should bear in mind that as early as October 2005, Chiron had a sensitive prototype vCJD test for human blood, and by February 2007, Canadian company, AMORFIX announced that they can now perform thousands of tests in a single day using a prototype commercial-scale blood test (EP-vCJD) for the diagnosis of variant Creutzfeldt-Jakob Disease.

Source: SEAC Meeting Notes for 10th May 2007, see points 1, 2,7,11
http://www.seac.gov.uk/papers/97-5.pdf
Additional Source: SEAC 95
http://www.seac.gov.uk/minutes/95.pdf
Type: Meeting Papers of the Spongiform Encephalopathy Advisory Committee (SEAC)
Location: UK
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2007, 15 May - Caroline Flint: "...Back It Up With Evidence and We'll Investigate"
On Question Time on 3 May, 2007, the Secretary of State for Health Patricia Hewitt, invited people to send her their questions, via the programme, about the NHS. Haemophiliac campaigner, Andrew March, wrote in to ask the following:

Question:

On Question Time (Thursday, 26th April), Caroline Flint, health minister, stated quite clearly: "If you make an allegation, back it up with evidence and we'll investigate". This may sound straightforward, however, it should be said that there is a problem with this procedure, in that the burden to present compelling evidence seems to be required prior to any inquiry taking place. Caroline Flint went on to say: "I think you need to have the evidence to put forward, to, I think have an inquiry because I think there is a problem of people just asking for inquiries on the basis of speculation?".

It is clear that the Department of Health (DoH) are rather fond of hiding behind this Catch-22-style situation and they have been known to help perpetuate this by withholding key evidence required by the haemophiliac community infected with HIV and Hepatitis C after receiving contaminated blood products under the NHS. How can there ever be a government-initiated inquiry into the contaminated blood catastrophe when the evidence required to provoke such an inquiry is still being suppressed?

A considerable amount of documentation has been released under the Freedom of Information Act and contained within this material was more than enough damning evidence which the Department of Health should surely have been privy to over the years, and particularly since July 2006. Speculation aside, infected and affected persons with haemophilia have issued a sharp accusation-based polemic against the government, the DoH and the medical profession. Yet, despite thoroughly backing-up such allegations with empirical evidence, the DoH remains silent.

Copies of Tainted Blood's "accusations documents" were sent to most senior officials at the DoH and we also know that a copy was forwarded to you from the Private Office of Her Majesty The Queen. Do you think it is fair or courteous not to respond?

I now urge the secretary of state for health to make an immediate statement, followed by expeditious action, whether in the form of a government inquiry, criminal prosecutions or other remedial measures.

___________________________________________________________________________

Answer: (Secretary of State for Health, Patricia Hewitt)

Terrible suffering has been caused to many haemophiliacs who were infected with hepatitis C or HIV through NHS treatment in the 1970s and early 1980s. That is why we set up the hepatitis C ex-gratia financial assistance scheme in July 2004, with the Macfarlane Trust supporting patients infected with HIV and their families.

There is a very substantial published body of evidence on the state of medical knowledge in the 1970s and early 1980s when non-A, non-B hepatitis (later known as hepatitis C) was initially viewed as a mild disease. The treatment that the NHS gave at the time was in line with that medical knowledge, which only changed as a result of research during the1980s.

As you say, the Department of Health has already released a great deal of information on this matter. The Department has also reviewed all the papers it holds between 1970 to 1985 that refer to non-A, non-B hepatitis. A copy of the review document will be made available on request to the Department.

Source: http://news.bbc.co.uk/1/hi/programmes/question_time/6656937.stm
Type: BBC Question Time - Patricia Hewitt answers your questions. 15th May 2007
Location: UK
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2007, 25 July - Professor Franklin Clarifies SNBTS Position on Spiking of Factor VIII with Viruses
On 25th July 2007, Professor Ian Franklin of the SNBTS gave an interview during the sixth hearing of Lord Archer's Independent Public Inquiry into Contaminated Blood & Blood Products:

Professor Ian Franklin:

"It has been discussed at this inquiry and also at other forums about the ethics of the trials. We certainly were driven in SNBTS by a desire to provide safe and sufficient products for patients. I would like to confirm that SNBTS has never provided any products for clinical use to which viruses have been added deliberately, nor has blood or plasma been imported by SNBTS to make plasma products up until the ban on UK plasma came into force in around 1988/99 due to BSE variant CJD precautions. So prior to that we never imported plasma to make Factor VIII.

"Now, obviously we do add viruses to samples in order to check in the laboratory that the steps aren't {are?} killing them off but these are done, quarantined away from patients' samples in different laboratories in a strictly controlled way to make sure that there is no possibility of cross contamination.

"I think it is a matter of regret and obviously perhaps a reflection on the lack of trust that it should even be thought that such testing as giving deliberately contamination treatments to patients has occurred. SNBTS certainly never did do that and I am not actually sure that some of the other comments by people really did reflect that that is what they were doing. I think they were perhaps purely {poorly?} drafted comments."


NOTE: Professor Franklin's testimony should be contrasted carefully with the information we already have on the practice of spiking. (see Related Entries link, below.)

Background: We know back in 1984, it was recorded that the methods used by the NHS and commercial companies could still leave active antigen in the product, so it is not surprising that TaintedBlood should read that BPL would then have to look at 'follow-up studies during 1985 with Haemophilia Centre Support'. If the virus-spiked product had been quarantined away from patients' samples in different laboratories in the strictly controlled manner that Professor Franklin described, then there would be no need to make reference to follow-up studies in actual haemophilia patients. We also know that in 1988, the products which were spiked with infectious virus for in vivo studies must have found their way into haemophiliacs' blood streams during what could only have been clinical use. Why else would documented evidence clearly state that patients then had to be followed-up for HIV seroconversion, hepatitis B markers or transaminase elevation so that the safety or adequacy of viral inactivation could be demonstrated?

Source: http://www.archercbbp.com/files/hearing/61_blood250707.doc
Type: Sixth Day Hearing Transcript (25.07.07) - Independent Public Inquiry into Contaminated Blood and Blood Products, chaired by Lord Archer of Sandwell.
Location: UK
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2007, 19 September - Professor Savidge - Other Sources of Obtaining Treatment ...
On Wednesday, 19th September 2007, Professor Geoffrey Savidge attended the Ninth Day Hearing of Lord Archer of Sandwell's Independent Inquiry. We can learn from Professor Savidge's statement that other sources of treatment were available - such as Japanese or German-produced, but it was not that there would not be any treatment, moreover, it was implicit upon the fact that there was an absence of money...

LORD ARCHER OF SANDWELL: "But the general wisdom on a number of these committees seems to have been: all right, there is a risk, (a), of an infection, and (b), that if there was an infection, it could be quite serious, but as against that there is the risk of not being able to obtain the treatment at all. That is what they were talking about, as far as I can see."

PROF. SAVIDGE: "I think it was not quite that from some of the understanding I have had from other sources. It was not that there would not be any treatment; it was that an absence of treatment would be detrimental, but that is implicit upon the fact that there is an absence of money."

LORD ARCHER OF SANDWELL: "Otherwise, there were other sources of getting it?"

PROF. SAVIDGE: "Sure."

LORD ARCHER OF SANDWELL: "I see what you mean."

PROF. SAVIDGE: "You had the Germans producing it, you had the Japanese producing it. Admittedly, half of the executive board of the Japanese Green Cross committed hara kiri after they found out that they had been transmitting a disease."

Source: Ninth day of Hearings - Mainly Scientific Community: Wednesday, 19th September 2007.
http://www.archercbbp.com/files/hearing/67_bc190907.doc
Type: Hearing Transcript of the Archer Independent Inquiry, 19th September 2007. (pgs 141-143)
Location: UK
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2007, 23 October - Lord Darzi of Denham - Department's Dealings with the Archer Inquiry
In a House of Lords Hansard of 23 October 2007, we read about 2 meetings between the Department of Health and the Independent Archer Inquiry, one of these meetings being as recent as 19 September 2007:

Lord Jenkin of Roding asked Her Majesty's Government:

"Why the Department of Health's response to the letter of 14 August from Mrs Harriet Bullock of Southwold, Suffolk, the widow of a National Health Service patient infected with contaminated National Health Service blood products, informed her that the independent public inquiry into contaminated blood products headed by Lord Archer of Sandwell had ignored the department's offer of a meeting with the inquiry; when the department's head of blood policy first saw Mrs Bullock's letter; when he informed Lord Archer of Sandwell of his view of the letter; under whose supervision the response was sent; and whether apologies have been offered both to the inquiry and to Mrs Bullock." [HL5488]

The Parliamentary Under-Secretary of State, Department of Health (Lord Darzi of Denham):
"I am very sorry that the reply from the department to Mrs Bullock to her letter of 9 July was open to misinterpretation. The letter was prepared by the customer service centre, using information supplied by the department's blood policy team, but did not fully reflect the department's dealings with the Archer inquiry. No criticism of the Archer inquiry team was intended in the reply of 14 August. An apology for the unfortunate wording of the original reply was sent to Mrs Bullock on 17 September and this was copied to the inquiry team."

"Our officials are co-operating fully with the Archer inquiry team, and have met with them twice, on 25 April and 19 September. In addition, we are releasing copies of official documents from 1970 to 1985 to assist their inquiries. It is expected that the final batch of documents will be released by the end of October."

Note: We have to pose the question: Why have the major campaign groups not been informed by the 'Public' Inquiry team that a further meeting with the Department has taken place. We are very disappointed that we have had to find out about such an important move through the Parliament website, and it is only thanks to the prudent actions and campaigning zeal of Mrs Harriet Bullock that we are even able to learn of this second meeting through public domain Hansard.

Source: http://www.publications.parliament.uk/pa/ld200607/ldhansrd/text/71023w0003.htm#07102331000019
Type: House of Lord Hansard - 'Health: Contaminated Blood Products', dated 23 October 2007 - Column WA104.
Location: UK
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2008, June - Is the USA a Safe Source of Plasma? Three vCJD cases found in U.S. since 2008
Since variant CJD was first reported in 1996, a total of 208 patients with this disease from 11 countries have been identified. The USA was initially deemed to be a safe source of plasma, but the country went on to have their own BSE crisis after the discovery of the first case on 23rd December, 2003.

From 1999, Life Resources Incorporated, USA, started supplying BPL Elstree, with plasma. It was stated in government Hansard that Life Resources Inc had "extremely high quality and safety standards overseen by the US Food and Drugs Administration and the UK Medicines Control Agency."

However, as of June 2008, three variant CJD cases had already been reported in the United States, along with one from Canada. Two of the three U.S. cases were likely to have been exposed to the BSE agent whilst residing in the United Kingdom. (Source: CDC factsheet, see link below).

Note: The statistics do not begin and end with vCJD, there are cases of classic CJD too. Between 1959 and 1985, thousands of people were treated with hGH (human growth hormone), and by May 1985, there were three U.S. cases of classic CJD recorded among the 10,000 hGH recipients. (Source: see ACVSB Volume 1, April 1989 below).
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2008, 12 June - Frank Maguire - Department of Health Are Acting Unlawfully in Not Holding an Inquiry
On Thursday, 12th June, Mr Frank Maguire, Solicitor Advocate, gave evidence at the final public hearing of the Archer Independent Inquiry into Contaminated Blood and Blood Products.

Mr Maguire pointed out that: 'The position in Scotland ... is very, very substantively the same issues with regard to England and Wales.'

When questioned by Mr Mehan, secretary to the Archer Inquiry, as to why he thought there was no English case which mirrored Lord Mackay's view about Article 2 of the Human Rights Act, he replied as follows:

Mr Maguire: "I do not understand why there's not, because the principles upon which the Scottish judgment is made is based on European law principles and also House of Lords judgments and Court of Appeal judgments.

"The leading case, the case of Takushis (?) [* Takoushis] where your Court of Appeal, and I mean England and Wales Court of Appeal, gave the circumstances under which Article 2 is applied in respect of NHS deaths, that is a judgment that Lord Mackay followed and that is one where he found that there must be an Inquiry in respect of a death arising out of a transfusion and a death arising out of Factor VIII. So there is no reason whatsoever in principle why the same -- why there cannot be a case in England to do the same, as happened with Lord Mackay's case. In any event, Lord Mackay, his pronouncement is giving the law as it is in the UK, not as it is in Scotland."

Mr Maguire: "Yes. But I think it has to be said, and this is my view based on Lord Mackay's judgment, that just now, the Department of Health and the Ministers and Westminster are acting unlawfully in not holding an Inquiry, contrary to Article 2."

"So it is not just a political question as to whether they want one or not. It is a legal question that they are acting unlawfully and are obliged to hold one."

"Now, the question that arises, and I have raised with the Civil Servants, is that it is inevitable that the facts and circumstances of the conduct we were looking at is here in Westminster and the Department of Health. So if anyone thinks that the Scottish inquiry stops at the borders of Scotland, it does not."

* R (Takoushis) v Inner North London Coroner [2006] 1 WLR 461

Source: http://www.archercbbp.com/files/hearing/72_blood120608v2.doc
Additional Source:
http://www.scotcourts.gov.uk/opinions/2008CSOH21.html
Type: Transcript of the Independent Inquiry into Contaminated Blood & Blood Products, 12th June 2008. (pp. 60-102).
Location: UK
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2009, 15 February - First Haemophiliac Known to have Contracted vCJD from Plasma Products
On 15th February 2009, the Telegraph reported that an elderly person with haemophilia had contracted vCJD from NHS Plasma products. The man was said to have died from another cause but vCJD was discovered following a post-mortem.

In September 2004 health officials wrote to 4,000 people with bleeding disorders, warning them that they were at a "small increased risk" of variant Creutzfelt-Jakob disease, the human form of mad cow disease. Most of these people were haemophiliacs.

Following the publication on 23rd February 2009 of the report and recommendations of the Lord Archer's Independent Inquiry into the issue of contaminated blood and blood products (see 3rd link below), TaintedBlood very much hopes that, following this latest disgraceful example of Department of Health incompetence over the handling of 'at-risk' patients, the Government finally tackles this appalling scenario head on and deals with it once and for all. This is the very least that could be expected for this small, vulnerable, grievously damaged community.

NOTE: TaintedBlood would like to express particular disgust at the way in which this news was released. We understand that none of the agencies dealing with the haemophilia community, such as the Haemophilia Society, were informed of what had happened. None of the 4,000 people known to have received vCJD-implicated batches of plasma products - most of whom were haemophiliacs - were afforded the opportunity to have any help or counselling prior to this announcement. We do not, however, express any element of surprise, since we have been warning of exactly this scenario since 1995/1996.

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2009, 23 February - Subsequent Health Crises, such as vCJD, Could Have Been Avoided...
On 23rd February 2009, Sophie Goodchild, Health Editor for the Evening Standard reported that Lord Archer of Sandwell, chairman of the Inquiry into Contaminated blood and blood products said that subsequent health crisis, such as vCJD, could have been avoided if officials had taken swift action...

"Lord Archer of Sandwell, who chaired the investigation, criticised ministers for failing to respond earlier to the disaster by halting imports of infected blood from countries including the US during the Seventies and Eighties. The former solicitor general said subsequent health crises such as variant CJD, the human form of mad cow disease, could have been avoided if officials had taken swift action."

In the transcript of the Press Conference, Lord Archer said: "The matter is not closed, because we are discovering viruses now that no one knew existed. So we could have learned all sort of lessons."

According to the Evening Standard, Lord Archer said:

"There could have been a system in place (if action had been taken earlier) and issues such as CJD might have been foreseen and even avoided"

Note: Please follow this link for the transcript of Lord Archer of Sandwell's Press Conference speech.

Source: http://www.thisislondon.co.uk/standard/article-23650189-details/Infected+blood+victims+%27deserve+apology+and+proper+compensation%27/article.do
Type: News Article - Evening Standard. Infected blood victims deserve apology and proper compensation 23.02.09
Location: UK
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2009, 24 February - Dr Charles Hay - Chairman UKHCDO - Ironic Comments on vCJD
On 24th February 2009, one day after the release of the report of the Archer Independent Inquiry, we find Dr Charles R. M. Hay making disturbing comments in the Telegraph. Dr Charles Hay, chairman of the UK Haemophilia Centre Doctors Organisation, stated the following:

"it is a misconception that the risk of contracting Hepatitis C was lower if patients were given UK products instead of American although it would have reduced the risk of catching HIV."

We would suggest that this statement is fundamentally flawed. It is the risk factors of the individual donor population that determine the overall level of risk, not the pool size during fractionation. UK sourced products often came from specially selected volunteer donor panels. Dr Hay goes on to state:

"...the irony was that if self sufficiency had been achieved then a larger proportion of haemophiliacs would have been exposed to donations from donors who went on to develop vCJD."

We absolutely disagree with this statement and pose the following questions as to who was responsible for allowing CJD (BSE) to enter into the human food chain: Who ignored all the warnings of scientists such as Dr Dealler? Who disregarded the significance of prions in blood products as shown in the minutes/background paper of the ACVSB meeting of January 1991? Who failed to develop and implement genetically-engineered factor products, i.e. recombinant, at the earliest opportunity?

We find it disturbing to see the chairman of the UKHCDO making such comments in the Daily Telegraph, since this was the very paper that, only 9 days earlier, had leaked devastating news about the first haemophiliac found to have vCJD at post-mortem. This patient was technically in the care Dr Hay in his role as chairman of the UKHCDO. We find it completely mystifying that on release of this article he did not speak out.

Comment: We feel the need to stress that BSE should never have made its way into the human food chain in the first place. It is, however, even more regrettable that Dr Charles Hay failed to seize this opportunity to apologise to the haemophilia community about the manner in which this news was broken. We are appalled to see him use the word irony in connection with a human tragedy of this magnitude.

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2009, 5 March - Lords Debate; The Earl of Onslow:
On Thursday, 5th March 2009, a short debate took place in the House of Lords. This was in response to a question by the Rt Hon The Lord Morris of Manchester asking when the Government could be expected to respond to the recommendations of the Independent Public Inquiry headed by Lord Archer of Sandwell into the 'infection and death of patients contaminated with HIV and hepatitis C by National Health Service blood and blood products':

The Earl of Onslow: My Lords, there is an expression that I was brought up with, which goes "fair words butter no parsnips".

Noble Lords: Liberal Democrats!

The Earl of Onslow: "My Lords, I am on my feet. Why should I break the habit of the lifetime? Fair words butter no parsnips. Would it not be much easier just to say that both Governments have made a terrible error in this issue and that compensation will be paid, period? That is all that needs to be said."

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2009, 8 March - Over 90% of Population to Receive Unsafe Blood?
It has been revealed that NHS patients who eat meat may be banned from receiving the safest blood supplies in order to halt the spread of variant Creutzfeldt-Jacob disease (vCJD). Only vegetarians and children under the age of sixteen who need transfusions would get imported blood, which the Government believes is free of vCJD.

The suggestion was apparently made as long ago as last year by the Government's advisory Committee on the Safety of Blood, Tissues and Organs (SABTO) and was apparently put forward as a result of the growing concern that contaminated blood from UK donors could lead to a second wave of infection.

According to the minutes of SABTO meetings from an unknown date last year, experts are considering this move as a: "risk reduction option" to ensure safer blood supplies for those who are less likely to have been exposed to vCJD in the 1990s, if the measures: "could not be applied to all recipients on the grounds of feasibility or cost-effectiveness." The blood would be sourced from countries where there has been no outbreak of vCJD in an attempt to reduce the risk of importing infected blood. However, this would not guarantee safety as Britain does not currently test blood for the presence of vCJD. According to the Government, a test of this kind is thought to be about a year away.

The population of the United Kingdom is approximately 61,000,000, of which only 5-10% is known to be vegetarian. Not all of these will have been vegetarian for life and will therefore have eaten meat at some stage. This means that at least 90% of the population would not receive "safer blood".

Comment:

  • We are appalled that, once again, history appears to be repeating itself. First of all, it is alarming that this issue of patient safety should only be brought to our attention by the press, particularly in light of the recent death of a Haemophiliac with vCJD, contracted from contaminated NHS blood.
  • At present, white cells and plasma are imported from America for this very reason, and yet we know that cases of vCJD have been identified in America, so we would pose the question: 'If the Government is prepared to accept this risk now, how can we guarantee safe imports in future?'
  • SABTO's proposals include plans to protect the under sixteens - the babies and children. Again, history seems to be repeating itself, as a similar ruling was in place when Colin Smith was given imported blood at two years of age. He went on to die of AIDS aged just seven.
  • We believe that it is perfectly possible to accurately test donated blood for vCJD now, and that the Government is employing dangerous delaying tactics, as they did with Hepatitis C, with cataclysmic results.
  • Even if these proposals never reach fruition, we would question the integrity of a Government advisory committee that discusses the health of our nation with such utter disregard for the past and such a shameful dismissal of our future. We believe that the government are putting cost-effectiveness before patient safety.
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2009, 17 March - House of Lord Debate - Amendment 133 - Moved by Lord Morris of Manchester
On Tuesday 17th March 2009, Amendment 133 of the Health Bill, moved by Lord Morris of Manchester, was debated at Committee stage in the House of Lords.

Lord Morris of Manchester: "For parliamentarians, there can be no higher duty than that of ensuring just treatment for those afflicted and bereaved by contaminated and life-threatening medication supplied by the state, and the emphatic backing of the report's recommendations by the mass media as a whole shows how clearly that duty is understood by the people of this country."

"It was just as clearly understood, too, by my right honourable friend Harriet Harman MP, Deputy Leader of the Labour Party and Leader of the House of Commons, when speaking on 5 March. Already having thanked my noble and learned friend Lord Archer, for his "important work", she told my honourable friend Dr Brian Iddon of her, "congratulations to the campaigners", on having, "brought to the public's attention the injustice that they have suffered", from contaminated NHS blood and blood products. She also made it clear to the House of Commons that: "The Government will respond shortly". Thus the Haemophilia Society now looks forward to a positive response to the landmark report that she so fulsomely welcomed.

Baroness Campbell of Surbiton: "The scandalously slow reaction by previous Governments to safeguard blood products imported from the United States meant that we failed to protect nearly 5,000 people who died or are now living with HIV/AIDS, hepatitis C or, now, CJD. The amendment proposes establishing a committee that will go some way to righting a great wrong which was done to those people. It is not a big initiative it is just a committee which would be a small, uncostly affair." (Column GC93-GC94)

Baroness Barker: "What I am most concerned about is that the Government's response should be timely and appropriate. It is a great shame that the Government did not contribute to the inquiry chaired by the noble and learned Lord, Lord Archer, but they are under an obligation to respond in a timely fashion. The government response perhaps needs to be in two parts: one an urgent response to the needs of people who are currently living with the consequences of being given these blood products, whose needs are urgent and serious, and the other on the wider question of what we should learn from the inquiry. That response would be much longer and more detailed." (Column GC94)

Earl Howe: "One of the things that I have learnt from the report is that there are too many haemophilia patients currently suffering hardship and serious distress as a result of this worst of all healthcare accidents in the history of the NHS. The Government have a moral obligation to give careful consideration to the report and to respond to its recommendations for the sake of those patients." (Column GC95)

Baroness Masham of Ilton: "A united committee could give support and information to those involved with this challenging speciality, which needs all the support it can get. This amendment may be the last on the Bill, but this is an important issue. The work with prions needs top scientists to find a way of protecting everybody from the dangers of contaminated or tainted blood. It could affect anyone at any time."

Lord Rea: "I have a quote from the report, which sums up the problem in a nutshell. Page 105 states:
"We must now look to the future. We cannot undo the damage done, nor turn back the clock to take a closer view of those past events and decisions. We must address the ongoing needs of those affected and consider how the state can ensure these citizens are recompensed.". This amendment does just that."

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2009, 17 March - Lord Morris of Manchester on Crown Immunity and BPL
On Tuesday 17th March 2009, Lord Morris of Manchester made important reference to Crown Immunity and BPL (raised in the Archer report) during the Committee Stage debate of Amendment 133 of the Health Bill:

CROWN IMMUNITY:

Lord Morris of Manchester: "The other issue to which I must finally refer is that of Crown immunity, on which the Archer report raises in commenting on behaviour of the Blood Products Laboratory (BPL). The report says:

In July 1979, the Medicines Inspectorate visited BPL. They reported that the buildings were never designed for the scale of production envisaged. They commented: "If this were a commercial operation we would have no hesitation in recommending that manufacture should cease until the facility was upgraded to a minimum acceptable level.".

"...The report then says: "BPL was rescued by Crown Immunity", and goes on to say that, "the existing plant continued production, relying on Crown Immunity to dispense with all the requirements of the Medicines Act, but was able to meet only about 40 per cent of the national requirements".

Lord Morris of Manchester: "Surely, words have lost their meaning if this does not mean that by the use of Crown immunity, a relic of feudal England, the lives of countless haemophilia patients were blatantly and gravely put at risk."

"...There could be no clearer text for describing the enormity of the use by the BPL of Crown immunity to dispense with all the requirements of that renowned and vital statute. I beg to move."

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2009, 17 March - vCJD: Sombre Threat Now of a Third Scourge Facing the Haemophilia Community
On Tuesday 17th March 2009, in a House of Lords Debate on Amendment 133 of the Health Bill, Lord Morris of Manchester makes important reference to the threat of vCJD to the haemophilia community:

"There are two other issues to which I must briefly refer. The first is the sombre threat now of a third scourge facing the haemophilia community. I refer to the increasing number of haemophilia patients known by the Department of Health to have received blood from donors who subsequently died of vCJD, and the recently reported case of one hepatitis C-infected patient, a post mortem on whom revealed vCJD in his spleen."

"I was informed more than once on the authority of the Chief Medical Officer that the risk for recipients of blood donors who subsequently died of vCJD was purely "hypothetical"; but that demonstrably is not the case now."

"Is donated blood currently being screened, or filtered to remove vCJD infection? If it is not, can my noble friend in replying to the debate say what protection is in place to safeguard recipients of donated blood? I understand, and my noble friend will confirm whether it is so, that technology is now available to remove by filter the abnormal prions which are the causative agent of vCJD and that it has passed EU-wide safety testing and clinical trials as required for its use in the UK..."

"...The haemophilia community, like Members of both sides of both Houses of Parliament, are anxious to secure ministerial assurances of urgent and effective action in this policy area, and I look forward to my noble friend's response to the questions that I have raised."

Source: House of Lords Debate: Amendment 133. Moved by Lord Morris of Manchester:
http://www.publications.parliament.uk/pa/ld200809/ldhansrd/text/90317-gc0008.htm#09031795000319
Type: Lords Hansard
Location: UK
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2009, 23 April - Lord Morris Was Told That vCJD Risk in Haemophiliacs Was Purely Hypothetical...
On 23rd April, 2009, Lord Morris of Manchester states that he was told on the authority of the Chief Medical Officer that the risk of infection in such cases was purely "hypothetical":

"In response to Parliamentary Questions about the growing number of haemophilia patients known by the Department of Health to have been treated with blood from donors who have since died of variant CJD, I was told on the authority of the Chief Medical Officer that the risk of infection in such cases was purely "hypothetical"."

"Today that demonstrably is no longer true, a recent post-mortem on a hepatitis C-infected patient having found vCJD in his spleen. Thus an urgent updating of ministerial statements made to Parliament on the vCJD threat is called for. Specifically we need to know the department's current figures for the number of patients treated with blood from vCJD-infected donors. We need also to know what action Ministers have taken since the post-mortem on the implications of its findings."

Background: In January 2001, the Government stated that the risk of infection with vCJD was merely hypothetical. At the time, Lord Morris stated in response to this that all he could say was that he was "quite certain that senior health officials would not want that theory to [be] put to the test on themselves..." (see Find Related Entries link below)

Source: http://www.publications.parliament.uk/pa/ld200809/ldhansrd/text/90423-0002.htm#90423-0002.htm_para7
Type: House of Lords Hansard - 23rd April 2009, Columns 1608-1609.
Location: UK
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2010, 19 Janaury - Lord Morris of Manchester - Role of Crown Immunity in Protecting BPL
In Lords Hansard of 19th January, 2010, unstinting supporter and advocate for the plight of persons with haemophilia, Lord Morris of Manchester, asked Baroness Thornton what part Crown Immunity played in protecting BPL from legal proceedings:

Lord Morris of Manchester:

To ask Her Majesty's Government what part Crown Immunity played in protecting the Blood Products Laboratory from legal proceedings for failing to comply with the Medicines Act 1968 to the hurt of haemophilia patients treated with contaminated NHS blood and blood products. [HL1134]
Baroness Thornton:
Crown Immunity gave no protection from civil legal proceedings. Some affected individuals who had acquired HIV infection through their treatment with blood products did bring a civil action in 1990, which was settled out of court.
Source: 19 Jan 2010: Column WA237. Health: Contaminated Blood Products
http://www.publications.parliament.uk/pa/ld200910/ldhansrd/text/100119w0004.htm
Type: Lords Hansard
Location: UK
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2010, 8 September - Penrose Preliminary Report - Crown Immunity and Licensing in Scotland
The Preliminary Report of the Penrose Inquiry, discusses the situation with respect to Crown Privilege and immunity from the licensing requirements of the Medicines Act:
"Unless otherwise provided, the Crown and its agencies are exempt from regulation. The Medicines Act provided that no exemption in the Act should be construed as derogating from Crown Immunity. This was interpreted as meaning that parts of the NHS such as health boards and the blood transfusion services did not have to comply with the licensing regulations, so long as the Act remained unqualified. The facilities at BPL (Elstree), PFL (Oxford) and PFC (Edinburgh) were part of the National Health Service and therefore were considered to have immunity from the Medicines Act 1968. On 1 April 1991 Crown Immunity was removed from the NHS by the National Health Service Community Care Act 1990."
Source: Preliminary Report of the Penrose Inquiry, Chapter 12.23
http://www.penroseinquiry.org.uk/preliminary-report/chapter-12/
Type: Penrose Evidence File
Location: Scotland
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2011, 24 February - SNBTS Operated Under Crown Immunity & Eventually Licensed in 1991
On 24th February 2011, a letter was sent from Thompsons Solicitors to Douglas Tullis, Solicitor for Penrose, stating:
"It should be noted that although SNBTS operated under Crown Immunity this operation was inspected by the UK Medicines Inspectorate and was found to be suitable and was eventually licensed when Crown Immunity was withdrawn in 1991."
Source: http://www.penroseinquiry.org.uk/finalreport/pdf/PEN0100386.PDF
Type: Penrose Evidence File
Location: Scotland
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2011, 13 October - Most Patients Included in These Figures Will Have Been children When Treated
In Chapter 22 of the Penrose Inquiry Final Report, our worst fears are confirmed as to the prevalence of children testing positive for HCV:

"Of the 29, six - all Haemophilia A patients - tested positive for HCV. The status of 14 patients (with Haemophilia A or B, von Willebrand disease, or, in one case a Haemophilia B carrier) was not known. Most patients included in these figures will have been children when treated."(9)
Source 9:
Professor Lowe: "And I think at that time all haemophilia directors were asked to look back at their patients during the period of time that you mentioned and produce data for that Inquiry as to how many patients at each haemophilia centre were treated for the first time with a blood product, and out of those 13 in the West of Scotland, my memory is that the majority of those would be children attending Yorkhill Hospital, the children's haemophilia centre, because obviously it's as a child that most patients with haemophilia get their first exposure to a blood product."
Source: Chapter 22 of the Penrose Inquiry Final Report, Source (9) (Professor Lowe - Day 54, page 60)
http://www.penroseinquiry.org.uk/downloads/transcripts/131011.PDF
Type: Penrose Evidence File
Location: Scotland
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