United Kingdom tainted blood scandal

The tainted blood scandal in the United Kingdom arose after approximately 4,670 people suffering from haemophilia and around 170 non-haemophiliacs became infected with hepatitis C and 1,243 of them were also co-infected with HIV, as a result of receiving contaminated clotting factor products supplied by the National Health Service (NHS) in the 1970s and 1980s.^[1][2] At least 2,400 haemophiliacs have been killed by the clotting agents and many others remain terminally ill.^[3][4] Of the 1,243 victims who were co-infected with both hepatitis C and HIV, less than 250 survive as of 2017.^[5]

It is often misreported by sections of the media that the treatments were "blood transfusions", using images of surgical blood transfusions and blood packs.^[6] Actually, the clotting factor was a processed pharmaceutical product falling under the Medicines Act and bore no resemblance to traditional blood transfusion. The infections were principally caused by the plasma 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.^[7] 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.^[8] In contrast, this was at a time when the practice of paying donors for whole blood in the US had effectively ceased; the UK did not import whole blood^[9] 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). The principle reason that the UK imported these products was that it did not produce enough of its own.^[10][11]

No government, healthcare or pharmaceutical entity in the UK has admitted any liability in the scandal, and no damages have been paid to those infected or affected, although the government has provided some benefits to the victims. In the 1990s the government made ex gratia payments averaging £60,000 to each infected person on the condition that they waived their right to pursue any further legal action.

A privately-funded independent inquiry set up in 2007 described the tainted blood scandal as "horrific" but stopped short of apportioning blame. In Scotland, a 2015 public inquiry concluded little could have been done differently and made just one recommendation; it was described by survivors as a whitewash.^[12] After years of increasing pressure from campaigners and MPs, in July 2017 Prime Minister Theresa May announced a full UK-wide public inquiry into the scandal.^[13][14]

Background

Haemophilia is a mostly inherited genetic disorder that impairs the body's ability to make blood clots, a process needed to stop bleeding.^[15][16] This results in people bleeding longer after an injury, easy bruising, and an increased risk of bleeding inside joints or the brain.

While there is no cure for the disorder, treatment can improve outcomes. Treatment is by replacing the missing blood clotting factors, which can take place at home or in hospital. The clotting factors are made either from human blood or by recombinant methods. In the 1970s haemophiliacs began to be treated with "factor concentrates", which were seen as a revolutionary treatment. The consequential surge in demand led to pharmaceutical companies seeking substantial supplies of blood, and thousands of donors including prisoners and drug addicts were paid to give their blood.

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).^[17]

• BPL: In 2013 the British government sold an 80% stake in the company to Bain Capital for approximately £230 million.^[18] In 2016 BPL was acquired by the Creat Group for £820m;^[19] the government stood to receive £164m from its remaining 20% share in BPL.

• Armour: In 1978 Armour was purchased by Revlon for $90m^[20] which owned the company until 1985 when it was sold to Rhône-Poulenc which purchased Revlon's drug operation for $690m in cash.^[21] 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.^[22]

• 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.^[23] In 2005 a new company, Talecris^[24] (set up by Cerberus Capital Management and Ampersand)^[25] acquired Bayer's plasma business and assets for $590m. Bayer however, did not include its recombinant Factor VIII "Kogenate"^[26] 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^[27] which charged the deal would be illegal. In 2011, a year after announcing the $4bn deal, Grifols completed a takeover of Talecris.^[28]

• Hyland/Travenol: Baxter created Travenol Labs in 1949 and acquired Hyland Labs in 1952.^[29] In 1993 Baxter was implicated in a lawsuit brought by haemophiliacs infected with HIV in the US^[30] and by the end of that year president James Tobin quit.^[31] In 1996 Baxter settled a lawsuit brought by haemophiliacs in Japan.^[32] In 2015 Baxter split-off its haemophilia sector to create Baxalta.^[33] In 2016 Baxalta was acquired by Shire plc for $32bn.^[34]

• Immuno: Baxter purchased Immuno AG in 1996 in an effort to keep up with competitors for some $715m.^[35][36]

Prior knowledge

The dangers of factor concentrates had first been raised in the early 1970s. In 1974 the American scientist Judith Graham Pool (who previously discovered the frozen blood product cryoprecipitate, a safer treatment), described the products as "dangerous", "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 US.^[37]

In May 1983 Dr Spence Galbraith, director of the Communicable Disease Surveillance Centre in England and Wales, sent a paper entitled "Action on Aids" to the Department of Health and Social Security stating: "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?".^[38] Despite Galbraith's warning the products were not withdrawn.^[39]

A study published in December 1983 showed conclusively that the risk to a haemophiliac of contracting hepatitis C by using these products was 100% upon first exposure.^[40]

Cover-up allegations

In a 1990 episode of The Cook Report, Lord David Owen said "I can see why some people would be unhappy with having all the facts revealed because it will show negligence".^[41]

On 23 September 2016 former Minister of State for Health, Lord David Owen, gave a speech in London stating the scandal had been covered-up.^[42]

Archer report

An Independent Inquiry into Contaminated Blood and Blood Products, chaired by Baron Archer of Sandwell, aimed to uncover the causes of the events that led to thousands of infections and deaths.^[43] Lord Robert Winston described it as "the worst treatment disaster in the history of the National Health Service".^[44]

The Inquiry sought to address the issue of missing evidence and documents relating to the scandal. For example, the ministerial papers of former Health Minister Lord David 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". Lord Jenkin also voiced his difficulties obtaining documents to the Inquiry, although the Inquiry states "He subsequently received from the Department two bundles of documents. One of these was to be treated as confidential".

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 inquiry goes onto state that "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."

Self-sufficiency

It is often highlighted by campaigners and critics that had the British government invested the money to make the UK self-sufficient in blood products, many lives could have been saved.^[45] Looking at this issue the Inquiry noted "it was known in the early 1970s that US commercial products carried an increased risk of infection. Indeed, some patients had become aware of this in various ways and were refusing treatment with those products, although the majority of patients had no idea of the danger". In May 1975, the World Health Organization (WHO) passed a widely circulated resolution, urging all countries to aim at self-sufficiency. Archer notes "it was not until 1978 that officials appreciated the concerns over infections from imported blood products. If that is so, it represents a serious oversight in the Department, or serious distortion of priorities. The destruction of the Departmental papers of Lord Owen and The Rt Hon Lord Jenkin of Roding has precluded us from investigating further the Departmental thinking and the extent to which ministers were made fully aware of the facts".

The BPL^[46] which manufactured UK Blood Products (which throughout the inquiry are described as being safer than US blood products) ran into continual trouble from under funding, the inquiry states "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". Archer goes onto find that "In 1987 Lord Owen learned that the objective of self-sufficiency in blood products had not been achieved. He wrote on 17 November to the Rt Hon John Moore, then Secretary of State for Social Services. Mr Moore replied on 21 January. The fact that the reply required eight weeks of research suggests that self-sufficiency was not a priority theme in the Department". Lord Owen told the Archer Inquiry that "having told Parliament on 8 July 1975 that the target was to achieve self-sufficiency ‘within two to three years’; the fact that the target had not been achieved should have been made known to Parliament".

To present day the UK never achieved its goal of self-sufficiency for plasma products, "In the 1990s, a new blood-born infection had appeared. Variant Creutzfeldt–Jakob disease (vCJD) had been identified in blood donated within the United Kingdom",^[47] and therefore subsequently UK-donated plasma ceased to be used.

References

External links

• Support Group for those affected and infected by Contaminated Blood & Blood Products
• The UK Haemophilia Society
• Video, News and Documentary Archive
• A group for those infected with Hepatitis C, through Contaminated Blood and Blood Products
• A historical chronology of events