Contaminated blood scandal in the United Kingdom

Contaminated blood was given to many thousands of people in the United Kingdom during the 1970s and 1980s.

On July 11, 2007, Kelly Duda testified at the Lord Archer Inquiry on Contaminated Blood in the Parliament of the United Kingdom. The British inquiry aimed to uncover the British government's part in a scandal that led to thousands of infections and deaths. Duda gave evidence as to the United State's role in the tragedy in what Lord Robert Winston has dubbed as "the worst treatment disaster in the history of the National Health Service".

Background 1959-1974

1948, 5 July - Creation of NHS - Crown Immunity The NHS is created and Crown Immunity is applied to all NHS bodies and premises.

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.

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.

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).

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.

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.

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.

1964, 16 October - Election - Change of Government The Labour Party gains power with Harold Wilson as Prime Minister.

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.

1966 - First Blood Clotting Factors are Produced The first blood clotting products for haemophiliacs are produced.

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.

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.

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.

1968, 1 November - DHSS Richard Crossman becomes Secretary of State for Health and Social Services.

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.

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.

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.

1970 - US Pharmaceutical Companies - Distribute Factor VIII / IX Four US-based pharmaceutical companies to distribute Factor VIII and Factor IX around the world.

1970s (early) - Factor Concentrates Become More Widespread The use of factor concentrates becomes more widespread.

1970s - BMJ Article - Juhani Leikola Britain is importing huge quantities of Factor VIII from the USA.

970s - 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.

1970 (early) - Lord Hunt of Kings Heath UK Clinicians are aware that there is a risk of Hepatitis being spread.

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.

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.

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. 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).

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.

1973 - First Imports - UK Starts to Import Factor VIII Products The UK starts to import Factor VIII products as early as 1973

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.

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."

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."

"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."

"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."

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.

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.

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."

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

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.

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.

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."

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.

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.

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.

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.

1974, 4 March - Election - Change of Government Harold Wilson becomes Prime Minister for the Labour Party.

4, 5 March - Government - Change of Minister Barbara Castle is appointed Secretary of State for Health and Social Services.

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. 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.

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.

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.

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.

See also

• Tainted blood scandal
• Contaminated haemophilia blood products

See also

• Tainted blood scandal
• Contaminated haemophilia blood products