Contaminated blood scandal in the United Kingdom

Contaminated Blood Scandal

Bottle of factor viii, a product used to treat haemophilia
Date	1970s & 1980s
Location	United Kingdom
Cause	Contaminated Factor VIII & Factor IX
Deaths	1,246+
Inquiries	Contaminated Blood Scandal Inquiry

The Contaminated Blood Scandal in the United Kingdom arose when at least 3,891 people with Haemophilia became infected with hepatitis C of whom 1,243 were also infected with HIV, the virus that leads to acquired immune deficiency syndrome (AIDS), as a result of receiving contaminated clotting factor products supplied by the National Health Service (NHS) in the 1970s and 1980s. As of October 2017 there were at least 1,246 confirmed deaths in the UK of people who were killed by the clotting agents Factor VIII & Factor IX and the viruses they transmitted. Some have estimated that the total number of those who have died could be as high as 2,400 though exact figures are not known.

Media have sometimes misreported the treatments involved as "blood transfusions", the Factor products used were a processed pharmaceutical product falling under the Medicines Act and bore no resemblance to blood transfusion. The infections were principally caused by the plasma derived product known as Factor VIII, a medicinal product that was sourced from the United States and elsewhere. The creation of such products involved dangerous manufacturing processes.^[1] Large groups of paid donors were used (as many as 60,000 per batch, and including prisoners and drug addicts); it only required one infected donor to contaminate an entire batch, which would then infect all of the patients that received that material.^[2] In contrast, this was at a time when the practice of paying donors for whole blood in the United States had effectively ceased; the UK did not import whole blood^[3] from abroad, but it did import large quantities of Factor VIII given to haemophiliacs (as described in the documentary Factor 8: The Arkansas Prison Blood Scandal). It is said that the principal reason that the UK imported these products was that it did not produce enough of its own.^[4][5]

A study published in 1986 showed that 76% of those who used commercial Factor products became infected with HIV, as opposed to none of those who only used previous treatment, Cryoprecipitate.^[6]

No government, healthcare or pharmaceutical entity in the UK has admitted any liability in the scandal, and no damages or compensation have been paid to those infected or affected, although the government has provided some means-tested benefits to some of the surviving victims through a Trust.^[7]

Background

Haemophilia is a mostly inherited genetic disorder that impairs the body's ability to clot, a process needed to stop bleeding.^[8][9] This results in people bleeding longer after an injury, easy bruising, and an increased risk of bleeding inside joints or other parts of the body.

Some people can now be cured from Haemophilia all-together,^[10] but modern "synthetic" or "non-human derived" Factor products such as Recombinant Factor VIII^[11] continue to be widely used. Factor products work by replacing the missing Factor proteins, which can take place at home or in hospital. The clotting factors are made either from Plasma or by recombinant methods. In the 1970s, haemophiliacs began to be treated with "Factor Concentrates", which were sold as a revolutionary treatment. The consequential increase in use led to pharmaceutical companies seeking substantial supplies of plasma, and thousands of donors including prisoners, drug addicts, prostitutes and people known to be infected with HIV or hepatitis were allowed or even paid to give their plasma.

Some of the most famous examples of risky plasma harvesting are those of Luckner Cambronne who became known as "The Vampire of the Caribbean"^[12] and also Crysosan Ltd, a company based in Canada that was found guilty of harvesting plasma from dead Russians bodies and re-labelling it as Swedish.^[13][14][15]

Products

Plasma donations could be collected using a process called plasmapheresis. In addition to NHS derived Factor produced by Bio Products Laboratory (BPL), manufacturers that supplied clotting factor products to the UK during the mid-1970s and 1980s included Abbott (Profilate), Armour Pharmaceuticals (Factorate), Bayer-owned Cutter (Koate), Baxter International-owned Travenol/Hyland (Hemofil/Interhem), Immuno (Kryobulin) and Speywood (Humanate).

• BPL: In 2013 the British government sold an 80% stake in the company to Bain Capital for approximately £230 million.^[16] In 2016 BPL was acquired by the Creat Group for £820m;^[17] the government stood to receive £164m from its remaining 20% share in BPL.
• Armour (Revlon): In 1978 Armour was purchased by Revlon for $90m^[18] which owned the company until 1987 when it was sold to Rhône-Poulenc which purchased Revlon's drug operation for $690m in cash.^[19] In 1996 Armour and Behringwerke were merged and became Centeon. In 1999 Centeon changed its name to Aventis Behring after the parent companies, Rorer and Hoechst AG merged to become Aventis. In 2004, CSL completed its acquisition of Aventis Behring for $925m, today known as CSL Behring.^[20]
• Bayer: Cutter Labs, which produced Factor VIII, was originally owned by Miles Laboratories. In 1974 Cutter Labs was purchased by Bayer, and in 1978 Bayer also purchased Miles Labs. In 1995 Bayer dropped the Miles Labs brand name.^[21] In 2005 a new company, Talecris^[22] (set up by Cerberus Capital Management and Ampersand)^[23] acquired Bayer's plasma business and assets for $590m. Bayer however, did not include its recombinant Factor VIII "Kogenate"^[24] in the sale and remains active in distribution internationally. In 2009, CSL Limited attempted to takeover Talecris for $3.1 billion but was stopped by the Federal Trade Commission^[25] which charged the deal would be illegal. In 2011, a year after announcing the $4bn deal, Grifols completed a takeover of Talecris.^[26]
• Hyland/Travenol (Baxter): Baxter created Travenol Labs in 1949 and acquired Hyland Labs in 1952.^[27] In 1993 Baxter was implicated in a lawsuit brought by haemophiliacs infected with HIV in the United States,^[28] and by the end of that year president James Tobin quit.^[29] In 1996 Baxter settled a lawsuit brought by haemophiliacs in Japan.^[30] In 2015, Baxter split-off its haemophilia sector to create Baxalta.^[31] In 2016 Baxalta was acquired by Shire plc for $32bn.^[32]
• Immuno AG: Baxter purchased Immuno AG in 1996 in an effort to keep up with competitors for some $715m.^[33][34]

1973 - 1986 - Hepatitis

The dangers of factor concentrates had first been raised since their inception. In 1974, American scientist Judith Graham Pool (who previously discovered the frozen blood product cryoprecipitate, a safer treatment) described the products as "dangerous" and "unethical" and warned against their use. The World Health Organization also warned the UK not to import blood from countries with a high prevalence of hepatitis, such as the United States.^[35]

In May 1975, the World Health Organization passed a widely circulated resolution urging all countries to aim at self-sufficiency in blood-products.

In December 1975 an episode of the World in Action programme highlighted the danger of Hepatitis from imported Factor products.^[36]

By the end of 1978 more than 50% of the Factor VIII used in England was being imported from overseas. This was because the country had failed to become self-sufficient in its own supplies.^[37]

The BPL,^[38] which manufactured UK blood products, ran into continual trouble from under-funding. The Archer Report said, "In July 1979, the Medicines Inspectorate visited BPL. They reported that the buildings were never designed for the scale of production envisaged. They commented: 'If this were a commercial operation we would have no hesitation in recommending that manufacture should cease until the facility was upgraded to a minimum acceptable level'. BPL was rescued by Crown Immunity. Among their recommendations the Inspectorate advised: 'Under no circumstances should production of any product be increased under the existing manufacturing conditions'. Meanwhile, the existing plant continued production, relying on Crown Immunity to dispense with all the requirements of the Medicines Act, but was able to meet only about 40% of the national requirements."

A study published in December 1983 showed conclusively that the risk to a haemophiliac of contracting Hepatitis C by using untreated Factor products was 100% upon first exposure.^[39]

1981 - 1986 - HIV

In July 1982 the American Centers for Disease Control and Prevention (CDC) reported that at least 3 haemophiliacs there had developed Pneumocystis carinii pneumonia, 2 had died, and all 3 had used untreated Factor products.^[40] The CDC said that "the occurrence among the three hemophiliac cases suggests the possible transmission of an agent through blood products".

In March 1983, the CDC reported that "Blood products or blood appear responsible for AIDS among hemophilia patients".^[41]

In May 1983 Dr N. S. Galbraith, director of the Communicable Disease Surveillance Centre in England and Wales, sent a paper entitled "Action on AIDS" to Dr Ian Field at the Department of Health and Social Security in London informing him of the death from AIDS of a haemophiliac who had received Factor VIII concentrate imported from the United States. Galbraith 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 ... 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?"^[42] Despite Galbraith's warning the products were not withdrawn: a Department of Health letter considered that his suggestion was "premature".^[43]

In September 1983 a leaflet distributed to UK blood donors answered the question as to whether AIDS could be transmitted by blood-products to be "Almost certainly yes".^[44]

In November 1983 the UK Health Minister, Ken Clarke told parliament that "There is no conclusive evidence that AIDS is transmitted by blood products" and the importation of infected products continued. When giving evidence to the Penrose Inquiry, Dr Mark Winter said that at the time Ken Clarke made this statement "all haemophilia clinicians by this stage clearly believed that commercial blood products could and were transmitting AIDS".^[45]

In January 1984 Lord Glenarthur (Parliamentary Under Secretary of State at the DHSS) said that "It remains the case that there is no conclusive evidence of the transmission of AIDS through blood products, although the circumstantial evidence is strong",^[46] and again the use of untreated Factor products and importation continued.

2000 - Destroyed Evidence Investigation

In April 2000 the Department of Health published an internal audit to examine the loss of records relating to Hepatitis C litigation. The report concluded that "an arbitrary and unjustified decision, most likely taken by an inexperienced member of staff, was responsible for the destruction of a series of files containing the minutes and background papers of the Advisory Committee on the Virological Safety of Blood (ACSVB)".

2009 - The Archer Report

In the early 2000s the former Solicitor General for England and Wales, Lord Archer, campaigned for an inquiry into the tainted blood scandal alongside Lord Owen, who was the Health Minister from 1974 to 1976, Lord Jenkin, former Shadow Health Secretary, and others. They were unsuccessful.

In a 1990 episode of The Cook Report, Owen said: "I can see why some people would be unhappy with having all the facts revealed because it will show negligence".^[47] In September 2016 Owen gave a speech in London during which he said the scandal had been covered-up.^[48]

Archer chaired a privately funded independent investigation set up in 2007. The Archer Report was published in 2009 and aimed to uncover the causes of the events that led to the thousands of infections and deaths.^[49] The report held no legal or official status and was unable to subpoena witnesses or demand the disclosure of documents.^[35] Nonetheless, it sought to address the issue of missing evidence and documents relating to the scandal. For example, the ministerial papers of Lord Owen had been destroyed. "We have been unable to ascertain who carried out the destruction of the papers, and who gave the instructions. But the conclusion appears inescapable that some official made a decision which he or she had no authority to make, or that someone was guilty of a serious error of judgement. The consequence is that Lord Owen has done his best to recollect details of events a quarter of a century ago, but both he, and we, have been deprived of the primary sources", Archer reported. Lord Jenkin also voiced his difficulties obtaining documents for the inquiry, although the report stated: "He subsequently received from the Department two bundles of documents. One of these was to be treated as confidential". Lord Jenkin felt that the destruction of records was deliberate, and done “in order to draw a line under the disaster”.^[50]

Another handling error is described in the inquiry: "mishandling of documents arose in connection with a number of files relating to the Advisory Committee on the Virological Safety of Blood between May 1989 and February 1992 which were found to be missing". The report went on to state: "They were in fact destroyed over a period from July 1994 to March 1998". When summarising these events it is stated "some of those who gave evidence to us suspected that there was an exercise in suppressing evidence of negligence or misconduct."

2015 - Scottish Penrose Inquiry

In 2008 the Scottish government announced a public inquiry into the scandal covering Scotland only, to be chaired by Lord Penrose. The inquiry's terms of reference outlined five deaths that were to be examined, but only one of those victims was a haemophiliac and that person had been infected with hepatitis C in the 1960s, before the factor concentrates were introduced.

Published in 2015, the inquiry was described as a whitewash and waste of public money (over £12 million) by critics after it made just one recommendation and failed to apportion any blame in the scandal. Its recommendation was to offer blood tests to anyone in Scotland who had a blood transfusion before 1991 and who had not already been tested for hepatitis C.

2017 - Legal Action & UK Public inquiry

In July 2017 a group legal action "Jason Evans & Ors" was brought against the government on behalf of more than 500 people by Collins Solicitors.^[51][52] After years of increasing pressure from campaigners and MPs, Prime Minister Theresa May announced a full UK-wide public inquiry into the scandal.^[53][54] In September 2017 a court ruling found in favour of the victims allowing them to launch a High Court action to seek damages.^[55][56][57]

2018 - False Ministerial Statements Withdrawn

In June 2018 the Department of Health issued an apology, because for 2 years Ministers had told Parliament that in relation to Contaminated Blood Scandal evidence; “All documents up to 1995 are available through the National Archive”.^[58]

Government Support

Successive governments, both Labour and Conservative, have been criticised for their handling of the case, limited support schemes and refusal to conduct a public inquiry (until 2017). Some limited support has been provided to selected individuals through charitable trusts^[7] which is often subject to means testing, though no damages or compensation have ever been paid to UK victims or their families.^[59][60]

In 1991 the Conservative government made £42 million available to those affected by HIV,^[61] this equates to around £29,000 on average between the 1,437 people who received a payment. By 1996 the majority of HIV victims were dead.

In 2017 the Conservatives announced more funds for those with first-stage chronic hepatitis C, but this additional money was reportedly to be sourced from funds for other tainted blood victims. The Department of Health was accused of robbing one set of victims to pay another. Officials stated that it had made available an extra £125 million, more than any previous government, but critics said this money was simply accounted for as a cost to the NHS of extending treatments to hepatitis C sufferers sooner.^[62]

References