Tainted blood scandal (United Kingdom)

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The "Tainted Blood Scandal" is the event of around 4,670 British haemophiliacs[1] being infected with Hepatitis C, 1,243 were also infected with HIV, "co-infected" by both viruses, through using Contaminated Clotting Factor Products, supplied by the NHS in the 1970s and 1980s and the subsequent government and corporate reaction.[2]

Over 2,000 British haemophiliacs have died due to their infection and many others are terminally ill.[3] Of the 1,243 Haemophiliacs who were infected with both Hepatitis C & HIV, only around 250 remain alive as of 2017.[4]

The infections were principally due to plasma products such as Factor VIII that unlike regular Blood Donations were often sourced from the United States and elsewhere. The creation of such products involved dangerous manufacturing processes.[5] Large groups of donors were used (as many as 60,000 per batch), it only took 1 infected donor to contaminate an entire batch, which would then infect all of the people that received that material.[6] 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 from the US or other countries, it did however import large quantities of Factor VIII given to Haemophiliacs.(see Factor 8: The Arkansas Prison Blood Scandal). The reason the UK imported dangerous products from overseas was because it had failed to produce enough of its own Factor VIII.[7][8]

No government, health or pharmaceutical entity in the UK has admitted liability for the scandal and no Damages have been paid to those infected or affected. Compensation has been paid in Ireland.[9]

On 24 November 2016 a motion in the House of Commons was passed stating "That this House recognises that the contaminated blood scandal was one of the biggest treatment disasters in the history of the NHS, which devastated thousands of lives".[10]

On 25 January 2017 the Welsh Assembly passed a motion calling on the UK Government to hold a full Public Inquiry into the scandal.[11][12]

Products[edit]

Plasma donations could be collected using a process called Plasmapheresis. In addition to NHS derived Factor produced by BPL, manufacturers that supplied clotting factor products to the UK during the mid-70's and 80's included Abbott (Profilate), Armour (Factorate), Bayer owned Cutter (Koate), Baxter owned Travenol / Hyland (Hemofil), Immuno (Kryobulin), Speywood (Humanate) and Baxter owned Hyland (Interhem).[13]

BPL - In 2013 the UK Government sold an 80% stake in the company to Bain Capital for approximately £230 million.[14] In 2016 BPL was acquired by the Creat Group for £820 Million,[15] the UK government stood to receive an additional £164 Million from its remaining 20% share in BPL.

Armour Pharmaceuticals - In 1978 Armour was purchased by Revlon for $90m[16] who owned the company until 1985 when it was sold to Rhône-Poulenc who purchased Revlon's drug operation for $690 million in cash.[17] In 1996 Armour and Behringwerke were merged and became Centeon. In 1999 Centeon changed its name to Aventis Behring after the parent companies, Rorer & Hoechst AG merged to become Aventis. In 2004, CSL completed its acquisition of Aventis Behring for $925 million, today known as CSL Behring.[18]

Bayer - Cutter Labs which produced Factor VIII was originally owned by Miles Laboratories, in 1974 Cutter Labs was purchased by Bayer, in 1978 Bayer also purchased Miles Labs. In April 1995 Bayer eliminated the Miles Labs brand name.[19] In 2005 a new company, Talecris[20] (Setup by Cerberus Capital & Ampersand[21]) acquired Bayer's plasma business and assets for $590 Million. Bayer however, did not include its recombinant Factor IIIV "Kogenate"[22] 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[23] who charged the deal would be illegal. On 1 June 2011, a year after announcing the $4 Billion deal, Grifols completed a takeover of Talecris.[24]

Hyland / Travenol - Baxter created Travenol Labs in 1949 and acquired Hyland Labs in 1952.[25] In 1993 Baxter was implicated in a lawsuit brought by hemophiliacs infected by HIV in the USA[26] and by the end of that year President James Tobin quit.[27] In 1996 Baxter settled a lawsuit brought by haemophiliacs in Japan.[28] In July 2015 Baxter split-off its Haemophilia sector to create Baxalta.[29] In June 2016 Baxalta was acquired by Shire PLC for $32 Billion,[30] the company has forecast revenues rising to $20 Billion by 2020.

Immuno AG - Immuno AG was purchased by Baxter in 1996 in an effort to keep up with competitors for some $715 Million.[31][32]

Prior knowledge[edit]

The dangers of Factor Concentrates had been raised going back to the early 1970s. In 1974 Judith Graham Pool (Who previously discovered Cryoprecipitate, a safer treatment), described the products as "dangerous", "unethical" and warned against their use.

On 9 May 1983 Dr Spence Galbraith, Director of the Communicable Disease Surveillance Centre (CDSC) in England and Wales sent a paper ‘Action on Aids’ to the Department of Health and Social Security (DHSS) 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". He goes onto say "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?".[33] Despite Galbraith's warning the products were not withdrawn.[34]

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[35] but the products were not withdrawn.

Investigations[edit]

In England successive Westminster governments have refused to investigate the scandal.[36]

In October 2016 Theresa May refused an investigation when responding to a call from Labour MP Diana Johnson.[37]

Cover-Up[edit]

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".[38]

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.[39]

Archer report[edit]

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.[40] Lord Robert Winston described it as "the worst treatment disaster in the history of the National Health Service".[41]

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[edit]

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.[42] 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 Organisation (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[43] 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",[44] and therefore subsequently UK-donated plasma ceased to be used.

Chronology of events[edit]

A historical chronology of events can be found at: http://www.taintedblood.info/timeline.php

See also[edit]

References[edit]

  1. ^ Evans, Andrew. "taintedblood.info". 
  2. ^ "The history of contaminated blood". 
  3. ^ "Contaminated blood inquiry begins". BBC News. 19 April 2007. Retrieved 3 June 2015. 
  4. ^ "OUR REMIT". 13 May 2016. 
  5. ^ "Bad Blood: A Cautionary Tale". 
  6. ^ User, Super. "Hemophilia Federation (India) - Product Safety". 
  7. ^ Meikle, James; correspondent, health (19 August 2002). "Owen demands inquiry into infected blood scandal" – via The Guardian. 
  8. ^ "HIV blood disaster papers 'were pulped'". 
  9. ^ "Lindsay Tribunal". 
  10. ^ "Contaminated Blood - Hansard Online". 
  11. ^ "Motion for Contaminated Blood". Factor News. 
  12. ^ "Call for contaminated blood inquiry after 70 deaths in Wales". ITV News. 
  13. ^ "Manufacturers" (PDF). 
  14. ^ "'Is there no limit to what this Government will privatise?': UK plasma". 18 July 2013. 
  15. ^ "PRESS RELEASE: Creat Group Corporation agrees to acquire Bio Products Laboratory Ltd. - Bio Products Laboratory Ltd.". 
  16. ^ https://www.nytimes.com/1977/07/06/archives/revlon-set-to-buy-armour-drug-units.html?_r=0
  17. ^ "RORER BUYS DRUG UNIT OF REVLON". The New York Times. 30 November 1985. 
  18. ^ "Saving Lives For More Than A Century - CSL Behring". 
  19. ^ AG, Bayer. "1988-2001 – A Journey through the History of Bayer". 
  20. ^ "Announcing the Launch of Talecris Biotherapeutics: Combining a Proud History of Patient Care with a Bold New Vision - Business Wire". 
  21. ^ "Ampersand". 
  22. ^ "Kogenate® FS, Antihemophilic Factor (Recombinant)". 
  23. ^ "FTC Authorizes Suit To Stop CSLs Proposed $3.1 Billion Acquisition of Talecris Biotherapeutics - Federal Trade Commission". 
  24. ^ "Grifols Worldwide :: Acquisition of Talecris". 
  25. ^ "History of Baxter International Inc. – FundingUniverse". 
  26. ^ "AIDS Suit Accuses Companies of Selling Bad Blood Products". AP. 4 October 1993 – via The New York Times. 
  27. ^ Letter, The Pharma. "TOBIN RESIGNS FROM BAXTER - Pharmaceutical industry news". 
  28. ^ FARLEY, MAGGIE (4 March 1996). "Baxter Is in Talks to Settle Tainted-Blood Suit in Japan" – via LA Times. 
  29. ^ "Baxalta Spins Off from Baxter - GEN Genetic Engineering & Biotechnology News - Biotech from Bench to Business - GEN". 
  30. ^ "Subscribe to read". 
  31. ^ Lipin, Steven; Journal, Thomas M. Burton Staff Reporters of The Wall Street (29 August 1996). "Baxter Will Acquire Immuno In Deal Valued at $715 Million" – via Wall Street Journal. 
  32. ^ "Baxter Purchasing Immuno, Swiss Blood-Products Maker". The New York Times. 30 August 1996. 
  33. ^ http://www.taintedblood.info/tlfiles/Galbraith%20Letter%20May%201983.pdf
  34. ^ "Preliminary Report Chapter 8: HIV and AIDS". 
  35. ^ Fletcher, M. L.; Trowell, J. M.; Craske, J.; Pavier, K.; Rizza, C. R. (10 December 1983). "Non-A non-B hepatitis after transfusion of factor VIII in infrequently treated patients.". Br Med J (Clin Res Ed). 287 (6407): 1754–1757. doi:10.1136/bmj.287.6407.1754. PMID 6416577 – via www.bmj.com. 
  36. ^ CampaignTB (14 September 2016). "Prime Minister's Questions - Diana Johnson MP - 14th September 2016" – via YouTube. 
  37. ^ "Correspondence regarding an Independent Panel to consider the Contaminated Blood Scandal". 
  38. ^ "The Cook Report - Profits Before Patients". 
  39. ^ Factor8Scandal (30 September 2016). "Lord David Owen - Bad Blood Speech 29/9/16" – via YouTube. 
  40. ^ Sam Marsden (23 February 2009). "Delays Led to Thousands Receiving Contaminated Blood". Independent.co.uk. Retrieved 2010-02-14. 
  41. ^ "Haemophilia grant protest at Lords". Channel 4. 2008-10-09. Archived from the original on 2008-10-10. Retrieved 2015-03-31. 
  42. ^ "BBC News - HEALTH - Haemophiliac HIV tragedy 'needless'". 
  43. ^ "BPL". 
  44. ^ "800 haemophiliacs given tainted blood at risk of vCJD". 20 May 2009. 

External links[edit]