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| place = [[United Kingdom]]
| place = [[United Kingdom]]
| cause = Contaminated Factor VIII & Factor IX
| cause = Contaminated Factor VIII & Factor IX
| reported death(s) = 1,246+
| reported death(s) = Over 2,400<ref name="Johnson1">{{cite news|last1=Johnson|first1=Diana|title=Blood contamination has killed 2,400. Why was this disaster ignored for so long?|url=https://www.theguardian.com/commentisfree/2017/jul/11/blood-contamination-has-killed-2400-why-was-this-disaster-ignored-for-so-long|accessdate=5 March 2018|work=The Guardian|date=11 July 2017}}</ref><ref name="Kazarian1">{{cite news|last1=Kazarian|first1=Melinee|title=The possible outcomes for victims of the tainted blood scandal, 40 years on|url=https://www.independent.co.uk/life-style/health-and-families/the-possible-outcomes-for-victims-of-the-tainted-blood-scandal-40-years-on-a7973266.html|accessdate=5 March 2018|work=The Independent|date=29 September 2017}}</ref>
| inquiries = [[Contaminated_blood_scandal_inquiry|Contaminated Blood Scandal Inquiry]]
| inquiries = [[Contaminated_blood_scandal_inquiry|Contaminated Blood Scandal Inquiry]]
| suspects =
| suspects =
Line 16: Line 16:
}}
}}
{{Use British English|date=August 2017}}
{{Use British English|date=August 2017}}
The '''tainted blood scandal''' in the United Kingdom arose after 3,891 people with [[Haemophilia]] became infected with [[hepatitis C]] and 1,243 of them were co-infected with [[HIV]], the virus that leads to [[HIV/AIDS|acquired immune deficiency syndrome]] (AIDS), as a result of receiving [[Contaminated haemophilia blood products|contaminated clotting factor products]] supplied by the [[National Health Service]] (NHS) in the 1970s and 1980s.<ref>{{cite web|title=The Fall-Out|url=https://www.factor8scandal.uk/the-fallout/|website=Factor 8 Campaign UK}}</ref> There are currently over 2,400 confirmed deaths in the UK of people who were killed by the clotting agents Factor VIII & Factor IX and the viruses they transmitted. Around 5,000 haemophiliacs became infected with hepatitis C and HIV following treatment with contaminated blood products, and many others remain [[Terminal illness|terminally ill]].<ref name="Johnson1" /><ref name="Kazarian1" />
The '''tainted blood scandal''' in the United Kingdom arose when at least 3,891 people with [[Haemophilia]] became infected with [[hepatitis C]] of whom 1,243 of those were co-infected with [[HIV]], the virus that leads to [[HIV/AIDS|acquired immune deficiency syndrome]] (AIDS), as a result of receiving [[Contaminated haemophilia blood products|contaminated clotting factor products]] supplied by the [[National Health Service]] (NHS) in the 1970s and 1980s.<ref>{{cite web|title=The Fall-Out|url=https://www.factor8scandal.uk/the-fallout/|website=Factor 8 Campaign UK}}</ref> 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<ref>{{cite web|url=https://static1.squarespace.com/static/58a18aeb2e69cf7248eeddbc/t/5af560a31ae6cf4b30e9d4b1/1526030500118/DH+Figures.jpg}}</ref>. Some have estimated that the total amount of those who have died could be as high as 2,400 though exact figures are not currently known.


It is often misreported by sections of the media that the treatments were "blood transfusions", this is not the case.<ref>{{cite web|title=Factor 8 Campaign|url=https://www.factor8scandal.uk/about-factor/|website=Factor 8 Scandal}}</ref> Actually, Factor products were a processed pharmaceutical product falling under the [[Medicines Act 1968|Medicines Act]] and bore no resemblance to traditional blood transfusion. The infections were principally caused by the [[Blood plasma|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.<ref>{{cite web|url=http://www.kpbs.org/news/2011/aug/04/bad-blood-cautionary-tale/|title=Bad Blood: A Cautionary Tale|publisher=}}</ref> 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.<ref>{{cite web|url=http://www.hemophilia.in/index.php/patient-education/product-safety|title=Hemophilia Federation (India) – Product Safety|publisher=}}</ref> 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<ref>{{cite web|last1=Simon|first1=Glenarthur|title=Blood: Licensing Requirements|url=http://hansard.millbanksystems.com/lords/1983/dec/05/blood-licensing-requirements|website=Hansard|publisher=House of Commons}}</ref> 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 principle reason that the UK imported these products was that it did not produce enough of its own.<ref>{{cite web|url=https://www.theguardian.com/society/2002/aug/19/NHS.medicineandhealth|title=Owen demands inquiry into infected blood scandal|first1=James|last1=Meikle|first2=health|last2=correspondent|date=19 August 2002|publisher=|via=The Guardian}}</ref><ref>{{cite web|url=https://www.telegraph.co.uk/news/uknews/1557187/HIV-blood-disaster-papers-were-pulped.html|title=HIV blood disaster papers 'were pulped'|publisher=}}</ref>
It is often misreported by sections of the media that the treatments were "blood transfusions", this is not the case.<ref>{{cite web|title=Factor 8 Campaign|url=https://www.factor8scandal.uk/about-factor/|website=Factor 8 Scandal}}</ref> Actually, Factor products were a processed pharmaceutical product falling under the [[Medicines Act 1968|Medicines Act]] and bore no resemblance to traditional blood transfusion. The infections were principally caused by the [[Blood plasma|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.<ref>{{cite web|url=http://www.kpbs.org/news/2011/aug/04/bad-blood-cautionary-tale/|title=Bad Blood: A Cautionary Tale|publisher=}}</ref> 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.<ref>{{cite web|url=http://www.hemophilia.in/index.php/patient-education/product-safety|title=Hemophilia Federation (India) – Product Safety|publisher=}}</ref> 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<ref>{{cite web|last1=Simon|first1=Glenarthur|title=Blood: Licensing Requirements|url=http://hansard.millbanksystems.com/lords/1983/dec/05/blood-licensing-requirements|website=Hansard|publisher=House of Commons}}</ref> 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 principle reason that the UK imported these products was that it did not produce enough of its own.<ref>{{cite web|url=https://www.theguardian.com/society/2002/aug/19/NHS.medicineandhealth|title=Owen demands inquiry into infected blood scandal|first1=James|last1=Meikle|first2=health|last2=correspondent|date=19 August 2002|publisher=|via=The Guardian}}</ref><ref>{{cite web|url=https://www.telegraph.co.uk/news/uknews/1557187/HIV-blood-disaster-papers-were-pulped.html|title=HIV blood disaster papers 'were pulped'|publisher=}}</ref>

Revision as of 17:10, 13 May 2018

Contaminated Blood Scandal
Bottle of factor viii, a product used to treat haemophilia
Date1970s & 1980s
LocationUnited Kingdom
CauseContaminated Factor VIII & Factor IX
Deaths1,246+
InquiriesContaminated Blood Scandal Inquiry

The tainted blood scandal in the United Kingdom arose when at least 3,891 people with Haemophilia became infected with hepatitis C of whom 1,243 of those were co-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.[1] 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[2]. Some have estimated that the total amount of those who have died could be as high as 2,400 though exact figures are not currently known.

It is often misreported by sections of the media that the treatments were "blood transfusions", this is not the case.[3] Actually, Factor products were 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 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.[4] 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.[5] 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[6] 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 principle reason that the UK imported these products was that it did not produce enough of its own.[7][8]

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.[9]

A privately funded independent review set up in 2007 described the tainted blood scandal as "horrific" but stopped short of apportioning blame and had no powers under the Inquiries Act. In Scotland, a public inquiry concluded in 2015 that little could have been done differently and made just one recommendation; it was described by survivors as a whitewash.[10]

In July 2017 a group legal action was brought against the government on behalf of more than 500 people.[11][12] After years of increasing pressure from campaigners and MPs, Prime Minister Theresa May announced a full UK-wide public inquiry into the scandal.[13][14] In September 2017 a court ruling found in favour of the victims allowing them to launch a High Court action to seek damages.[15][16][17]

Background

Haemophilia is a mostly inherited genetic disorder that impairs the body's ability to clot, a process needed to stop bleeding.[18][19] 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,[20] but modern "synthetic" or "non-human derived" Factor products such as Recombinant Factor VIII[21] 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"[22] 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.[23][24][25].

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).[26]

  • BPL: In 2013 the British government sold an 80% stake in the company to Bain Capital for approximately £230 million.[27] In 2016 BPL was acquired by the Creat Group for £820m;[28] the government stood to receive £164m from its remaining 20% share in BPL.
  • Armour (Revlon): In 1978 Armour was purchased by Revlon for $90m[29] which owned the company until 1987 when it was sold to Rhône-Poulenc which purchased Revlon's drug operation for $690m in cash.[30] 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.[31]
  • 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.[32] In 2005 a new company, Talecris[33] (set up by Cerberus Capital Management and Ampersand)[34] acquired Bayer's plasma business and assets for $590m. Bayer however, did not include its recombinant Factor VIII "Kogenate"[35] 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[36] which charged the deal would be illegal. In 2011, a year after announcing the $4bn deal, Grifols completed a takeover of Talecris.[37]
  • Hyland/Travenol (Baxter): Baxter created Travenol Labs in 1949 and acquired Hyland Labs in 1952.[38] In 1993 Baxter was implicated in a lawsuit brought by haemophiliacs infected with HIV in the US[39] and by the end of that year president James Tobin quit.[40] In 1996 Baxter settled a lawsuit brought by haemophiliacs in Japan.[41] In 2015 Baxter split-off its haemophilia sector to create Baxalta.[42] In 2016 Baxalta was acquired by Shire plc for $32bn.[43]
  • Immuno AG: Baxter purchased Immuno AG in 1996 in an effort to keep up with competitors for some $715m.[44][45]

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.[46]

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 US. 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?".[47] Despite Galbraith's warning the products were not withdrawn: a Department of Health letter considered that his suggestion was "premature"[48]

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.[49]

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[9] which is often subject to means testing, though no damages or compensation have ever been paid to UK victims or their families.[50][51]

In 1991 the Conservative government made £42 million available to those affected by HIV,[52] 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.[53]

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.[54]

Independent inquiry

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".[55] In September 2016 Owen gave a speech in London during which he said the scandal had been covered-up.[56]

Archer chaired a privately funded independent report set up in 2007, which concluded in 2009 and aimed to uncover the causes of the events that led to the thousands of infections and deaths.[57] The report held no legal or official status and was unable to subpoena witnesses or demand the disclosure of documents.[46] 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”. [58]

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."

Scottish Penrose Inquiry

Main article: 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.

Public inquiry

In July 2017 the Prime Minister Theresa May announced that a full, UK-wide public inquiry would take place into the contaminated blood scandal. Following the announcement victims and campaigners decided to boycott the involvement of the Department of Health, who are alleged to be a liable party[59]. The victims have suggested the Cabinet Office or Ministry of Justice should oversee the inquiry to avoid possible conflicts of interest.[60]

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.[61] Looking at this issue Archer's inquiry noted that "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 passed a widely circulated resolution urging all countries to aim at self-sufficiency. Archer noted that "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 Lord Jenkin has precluded us from investigating further the Departmental thinking and the extent to which ministers were made fully aware of the facts".

The BPL,[62] 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 stating that "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 also found 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 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 the 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",[63] and therefore subsequently UK-donated plasma ceased to be used.

References

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  3. ^ "Factor 8 Campaign". Factor 8 Scandal.
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  35. ^ "Kogenate® FS, Antihemophilic Factor (Recombinant)".
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  56. ^ Factor8Scandal (30 September 2016). "Lord David Owen – Bad Blood Speech 29/9/16" – via YouTube.{{cite web}}: CS1 maint: numeric names: authors list (link)
  57. ^ Sam Marsden (23 February 2009). "Delays Led to Thousands Receiving Contaminated Blood". Independent.co.uk. Retrieved 14 February 2010.
  58. ^ The Archer Inquiry. 2009. On 13 April 2005 Lord Jenkin met Sir Nigel, who apologised for the original reply. Lord Jenkin was left with the clear impression from their subsequent conversation that all the files bearing upon the issue of contaminated blood products had been destroyed, and that this had been done 'with intent, in order to draw a line under the disaster'.
  59. ^ editor, Rowena Mason Deputy political (31 August 2017). "Andy Burnham urges Theresa May to rescue contaminated blood inquiry". The Guardian. {{cite web}}: |last1= has generic name (help)
  60. ^ "Former Liverpool Bishop to meet families affected by contaminated blood products". ITV News.
  61. ^ "Haemophiliac HIV tragedy 'needless'". BBC.
  62. ^ "About BPL – Bio Products Laboratory Ltd". www.bpl.co.uk.
  63. ^ "800 haemophiliacs given tainted blood at risk of vCJD". 20 May 2009.
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