Tainted blood scandal (United Kingdom)

The "Tainted Blood Scandal" is the event of nearly 5,000 people being infected with the Hepatitis C and 1,200 being infected with HIV, often during treatment for Haemophilia or Blood Transfusion by the NHS in the 1970s and 1980s and the subsequent government reaction. In 2007 1,600 people had died due their infection and many were terminally ill.[1] The infections were principally due to plasma products such as Factor VIII that were sourced from the United States from large groups of donors who were sometimes paid for their donation. (see Factor 8: The Arkansas Prison Blood Scandal). Manufacturers that supplied blood products to the UK included Abbott (Profilate), Armour (Factorate), Bayer owned Cutter (Koate), Hyland (Hemofil), Immuno (Kryobulin), Speywood (Humanate) and Baxter owned Hyland (Interhem).[2]

To date no government, health or pharmaceutical entity in the UK has admitted liability for the scandal and no compensation has been paid to those infected or affected. Compensation has been paid in Ireland.[3]

Despite numerous calls from campaigners, victims and MP's over the years, successive governments in Westminster have refused to hold a Public Inquiry into the matter.

In a 1990 episode of The Cook Report former British Health Minister Lord David Owen said "I can see why some people would be unhappy with having all the facts revealed because it will show negligence".[4]

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.[5] Lord Robert Winston described it as "the worst treatment disaster in the history of the National Health Service".[6]

Notable findings of the Archer Inquiry:

Missing Documents

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. 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 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[7] 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 it's goal of self-sufficiency for plasma products, "In the 1990s, a new blood-born infection had appeared. Variant Creutzfeldt-Jacob Disease (vCJD) had been identified in blood donated within the United Kingdom, and therefore subsequently UK-donated plasma ceased to be used. The Department of Health purchased a commercial plasma supply company in the United States, and the United Kingdom now employs American commercial plasma for its needs. Thus ended the quest for self-sufficiency".

Key Events

In 1980 Blood from Scottish prisoners is used in NHS transfusions despite serious concerns that the practice is unsafe.[8]

On the 6th Oct 1980 Dr. Edward Shanbrom, a former Baxter scientist, filed a patent for a solvent detergent treatment process for viral inactivation of factor concentrate. He approached all 4 US pharmaceuticals about implementing the solvent detergent method, however all 4 companies refused to implement the method. Dr Shanbrom described the implementation of this process to be "as easy as washing your hands".[9] It wasn't until 1988 (by this time most haemophiliacs had been infected) that the New York Blood Center purchased his patent.[10]

According to the National Institute for Biological Standards and Control (NIBSC), in November 1980, Armour AHF Batch no. J70902 is reported to have given rise to 3 separate incidents of various types of hepatitis in 3 persons with haemophilia.[11]

Professor Zuckerman, from the World Health Organisation (WHO), speaking on ITV's World in Action in 1980: The Blood Business, stated that there was an increase in the occurrence of hepatitis indicated by jaundice among haemophilia patients and that he believed that this was due to commercial imports of Factor VIII from Europe and the United States.[12]

In 1981 the US Centre for Disease Control and Prevention organises a task force in response to a disease later called Acquired Immuno Deficiency Syndrome, shortened to AIDS.[13]

In February 1981, 10 children at the Treloar specialist school in Alton, Hampshire are infected with hepatitis from contaminated Factor VIII, there then follows a warning regarding infected Factor VIII supplies being imported from the USA.[14]

A letter to all Haemophilia Centre Directors on 11 January 1982 reads "Infectivity of initial batches is tested by injecting the product into Chimpanzees. However, it is stated that it is unlikely that Manufacturers would be able to ensure this form of quality control in all future batches".[15]

On 3 February 1982 the New Scientist reported that haemophilia sufferers were at risk of contracting AIDS and in the summer of 1982 some haemophilia patients in the US were diagnosed as suffering from AIDS.

Kenneth Clarke becomes Minister of State for Health on 5 March 1982, and remains so until September 1985.

On the 6th July 1982 the first US haemophiliac victim of AIDS is reported. An American report of pneumocystis pneumonia death in a haemophiliac where there was evidence of cellular immune deficiency with possible transference through blood.[16]

In 1983 British Medical Journal publishes evidence that "a very high percentage of Haemophiliacs contract Hepatitis C after 1st use of concentrates".[17]

In January 1983 an editorial in the New England Journal of Medicine suggested that cryoprecipitate should be used in preference to Factor concentrates." (This did not universally happen in the UK).

On the 15th March 1983 Dr. Bruce Evatt of the CDC informed Cutter that based upon the observed T-cell abnormalities in hemophiliacs, he expects 50% of them to develop full blown AIDS.[18]

In a paper prepared in May of 1983 for the Biological Sub-Committee of the C.S.M., Dr. N. S. Galbraith, Director of the Communicable Disease Surveillance Centre (part of the Public Health Laboratory Service), advised that all products made from blood donation in the USA after 1978 should be withdrawn.[19] (His advice was not put into place).

On 6th May 1983, the CDSC telephones the DHSS to inform them that a 23 year old haemophiliac patient in Cardiff is now showing the appropriate symptoms for an AIDS diagnosis. This man had been infused with American Factor VIII.[20]

On the 13th July 1983 the CSM advised that "very little is done about the threat of AIDS to haemophiliacs".[21]

In a PHLS letter of October 1984, two alternative strategies for the follow-up of haemophiliac patients who have received a HIV implicated batch are deliberated. The option of not informing patients is considered: Dr. Craske: "An alternative strategy would be not to tell the patient of the risks involved but to observe him at regular clinical review four monthly, to collect serum specimens for HTLV-3 antibody examination and send them to me at Manchester.[22]

See also

References

  1. ↑ "Contaminated blood inquiry begins". BBC News. 19 April 2007. Retrieved 3 June 2015.
  2. ↑ "Manufacturers" (PDF).
  3. ↑ "Lindsay Tribunal".
  4. ↑ "The Cook Report - Profits Before Patients".
  5. ↑ Sam Marsden (23 February 2009). "Delays Led to Thousands Receiving Contaminated Blood". Independent.co.uk. Retrieved 2010-02-14.
  6. ↑ "Haemophilia grant protest at Lords". Channel 4. 2008-10-09. Archived from the original on 2008-10-10. Retrieved 2015-03-31.
  7. ↑ "BPL".
  8. ↑ "1980 Scottish Prisoners".
  9. ↑ "Solvent Detergent Patent".
  10. ↑ http://www.legacy.com/obituaries/latimes/obituary.aspx?page=lifestory&pid=156224568#. Missing or empty |title= (help)
  11. ↑ "Armour AHF Batch no. J70902" (PDF).
  12. ↑ "1980 ITV - World In Action" (PDF).
  13. ↑ "CDC Taskforce on AIDS".
  14. ↑ "£30m Could Have Kept AIDS Out" (PDF).
  15. ↑ "Oxford - Chimp Tests Letter" (PDF).
  16. ↑ "Haemophiliac HIV Litigation, Advice on Settlement Document, Appendix 1, Chronology, pp 56-58.".
  17. ↑ "Fletcher ML, Trowell JM, Craske J et al. Non-A non-B hepatitis after transfusion of factor VIII in infrequently treated patients. BMJ 1983;287:1754-7.".
  18. ↑ "Class Action Complaint (2004) Case No. C032572 PJH Page 28".
  19. ↑ "Dr Galbraith Warning" (PDF).
  20. ↑ "First UK Aids Victim" (PDF).
  21. ↑ "CSM Meeting Minutes" (PDF).
  22. ↑ "PHLS Letter October 1984" (PDF).

External links

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