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.scottish.parliament.uk/business/committees/health/papers-06/Ag2MackieSubmission.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 HCV 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)
Type: Allocation. Taken from 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.scottish.parliament.uk/business/committees/health/papers-06/Ag2MackieSubmission.pdf
Type: Correspondence
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 – 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.ucl.ac.uk/histmed/PDFS/Publications/Witness/wit4.pdf
Type: Transcript, edited by D A Christie and E M Tansey: “HAEMOPHILIA: RECENT HISTORY OF CLINICAL MANAGEMENT”.
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
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 – 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 states, “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: Paid Consultants - HCDO
Location: UK
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1977, 13 January - Dr Waiter, HCDO
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, 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
BPL reaches it’s 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
Defendants 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 ‘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 – 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 SSCM Website: www.slowlyslowlycatchymonkey.com

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 Debates, 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 iu pa.
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..." (see pages 16-17 of the PDF link to Carol Grayson's dissertation, below).

Campaigner and researcher Carol Grayson (who sourced this letter), identifies in her MA dissertation the anomaly of why the DOH Self-Sufficiency Report into Blood Products of 2006 insists that the prevailing medical opinion in the 1970s and the early 1980s was that NANBH was "mild and often asymptomatic", when it is quite clear that Dr Diana Walford was fully aware in 1980 that 90% of hepatitis was caused by NANBH and could be rapidly fatal.

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: Carol Grayson: Blood Flows Not Just Through Our Veins But Through Our Minds. How Has The Global Politics of Blood Impacted on the UK Haemophilia Community (pps. 16-17):
http://www.slowlyslowlycatchymonkey.com/Carol_Grayson/ANNEX_A_CHRONOLOGY_OF_EVENTS.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 !
Craske claims that NANBH 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 - 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: Zuckerman AJ. “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 iu pa 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 60°C 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
Conrad article discusses the various viruses transmissible by blood products, including exotic ones.
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) ' Kaposi's 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
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.

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, 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
Top
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
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 predates (by 2 months) our earliest known point of awareness of AIDS by the UKHCDO (in September 1982) where Dr Craske was tasked with looking into reports of the syndrome in 3 haemophiliacs from the United States.

Source: DHSS Circular. Dated 16 July 1982. From DOH FOI Documents, Vol 24, page 171
http://www.taintedblood.info/tlfiles/DHSS HS1A Letter American Factor VIII 16 July 1982.pdf
Type: DHSS Internal Circular Room 1208, HS1A. Dated 16 July 1982
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 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 ‘82 to mid-January ‘83).
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
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1983, 4 January - CDC / PHS Meeting
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
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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 Centers 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 BAXTER’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, 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 4 Page 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.
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 'Import of Blood Products'. Dated 10th May, 1983,
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 'Factor VIII and AIDS'
    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: Self-sufficiency in Blood Products in England and Wales – A Chronology from 1973-1991. DOH (2006), pgs 2, 44.
    Additional Source: 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, 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, 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’s 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, 19 July - FDA BPAC Meeting
    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 (defendants) 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 July 19th 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 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
    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)

    Opportunities 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
    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
    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 60°C 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 60°C 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
    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
    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
    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 68°C 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
    Alpha receives approval in February 1984 for factor concentrates subjected to a wet heat treatment process at 60°C 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, 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 60°C 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 the UK's Own 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 achieve)." (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 Document - Proposed Working Group of the Advisory Committee on the National Blood Transfusion Services - Consequences to the NBTS of Screening for HTLV III. 13 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 68°C 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?

    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 68°C 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 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