? Unanswered Questions...
During my lifetime, I wish to be fortunate enough to hear someone of an official capacity attempt to provide adequate answers to the following list of currently unanswered questions:
Why, in 1972 and 1973, did Government make the somewhat misguided decision to import US clotting factors from paid donors into the UK and to grant them licenses or in some cases, import the products without granting or even signing licenses?
...and don't forget to mention plasmapheresis... (Def. Plasmapheresis is the centrifuging of blood that has been removed from the body to separate the cellular elements from the plasma..) The process was known about as a means of collecting plasma for fractionation from c. 1964 and could have been used throughout the 1970’s to more rapidly and more efficiently take blood from voluntary donors within the UK. If the answer to the above question on importation included the excuse of insufficient voluntary donor blood being available in the United Kingdom, then could I please have an explanation as to why plasmapheresis was not implemented in the UK, other than for extracting valuable antigen / antibodies c. 1973 from selected haemophiliacs who had been exposed to Hepatitis? Plasmapheresis would certainly have helped the UK towards the much sought-after, and never attained, self-sufficiency in blood products. If the process of plasmapheresis was good enough for the commercial sector in the USA, then why was it not used here in the UK?
Why did Dr William Maycock, head of the Blood Transfusion Service ignore an important warning letter in 1975 from Dr J Garrott Allen, former Professor of Surgery, Stanford University, who wrote to him with regard to the risks of non-A non-B hepatitis from commercial blood from paid donors?
Why, in 1975, was the £500,000 that was supposed to be set aside for the protection of haemophiliacs (by increasing the production of factor VIII as part of the drive for UK self-sufficiency in blood products) somehow diverted to other purposes?
Why were the Lister Institute of Preventative Medicine’s Chelsea Laboratories allowed to become so under-funded that they were forced to close in 1975?
Why did the United Kingdom fail to become self-sufficient in blood products even after the World Health Organisation (WHO) had issued a resolution in 1975 stating that each country should be able to supply sufficient quantities of its own blood and blood products to meet clinical needs?
When the facilities of both the BPL Elstree and PF (Plasma Fractionation) laboratories were found to be inadequate in October 1976, why wasn't anything substantial done to rectify the situation?
Why was a collaborative clinical trial between the condemned BPL laboratory at Elstree and a school called the 'Lord Mayor Treloar College' allowed to take place in 1976? Why was factor VIII concentrate (made in a condemned facility) allowed to be intravenously injected into children?
Why were the world-renowned Elstree laboratories of the Lister Institute forced to be wound up in 1978? Why allow a research facility so well-poised that they could have developed heat-treatment & even a screening test for Non-A Non-B hepatitis to flounder and become so unfeasible?
In 1979, why would any physician write a letter, on behalf of the Public Health Laboratory Service, to a children's hospital in the Lord Mayor Treloar College making the suggestion of transfusing mild haemophiliacs with a questionable 'material' which would have caused the pupils to develop hepatitis? Perhaps Dr Craske could explain?
As Carol Grayson quite rightly points out in her dissertation, when Dr Diana Walford, a DHSS doctor, stated in writing in 1980 that 90% of all post-transfusion & blood product infusion hepatitis in the USA and elsewhere was caused by non-A, non-B hepatitis viruses and could be rapidly fatal (particularly when acquired by patients with pre-existing liver disease), why wasn't any preventative action taken by the DOH, and why was it that a myth was allowed to be propagated that NANBH was "mild and often asymptomatic"?
When the Medicines Inspectorate report of December 1980 found that the laboratory of BPL Elstree did not conform to acceptable industry standards (because there was water dripping from overhead metal panels, mould growth and plaster breaking off in parts of the building), why did Government not close down the facility?
In 1980, when the RCMP (Royal Canadian Mounted Police) conducted their investigation into the shady practices of the international blood-broker Cryosan, did they manage to determine whether any of the cadaveric blood made its way into the United Kingdom, either directly through Cryosan or via U.S. pharmaceutical companies such as Hyland / Travenol Belgium?
In January 1982, when commercial manufacturers were unable to ensure initial batch infectivity by injecting their 'heat-treated' Factor VIII into chimpanzees, why did physicians at the HCDO (now UKHCDO) allow and encourage studies (in vivo infectivity tests) in human beings (including children) in order to test the extent to which virus infectivity had been reduced?
When we discover that in March 1982 that Dr C. Rizza and Dr J. Craske were running prospective trials of "first time" haemophiliacs receiving suspect infective medicines, we have to ask, whether in practice, this meant that the haemophilic subjects being included in these trials would have been patients who were previously unexposed to large pool concentrates and by virtue of this lack of exposure, whether they would have been haemophilic children or mild to moderate haemophiliacs? So why endanger them?
In March 1982, at a time when chimpanzees were an endangered species and cost £10,000 per animal for just 6 months testing, how could it be deemed ethical and even remotely appropriate to consider using humans instead of animal models for (in vivo) infectivity studies? (follow the link to read the quotation.)
When the UK Haemophilia Centre Directors' Organisation had knowledge of AIDS in 1982 and of US haemophiliacs being infected through commercial blood products, why did the UKHCDO not do more to protect UK haemophiliacs?
In 1983, after having received a serious warning letter from Dr N. Galbraith of the PHLS, why did the DHSS not withdraw US blood products made from blood donated from 1978 onwards?
When the Council of Europe agreed a resolution in 1983 to take all necessary steps and measures in respect of AIDS, why did the UK find it so difficult to even remotely follow this recommendation?
How was it possible for the Committee on Safety of Medicines (CSM), Biologicals Sub-Committee to fail to withdraw contaminated US clotting factors and replace them with cryoprecipitate during the AIDS crisis in 1983? Why did the government's advisers on medicine, who knew that patients were at risk of contracting Aids from imported blood products as early as 1983, rule against a ban? (Read Sarah Hall's article in the Guardian)
Why did Lord Glenarthur of the DHSS state (rather incredibly) that he was satisfied that the decision in 1983 to carry on using the current stock of contaminated United States Factor VIII was justified?
In 1983, it was recorded in minutes that the Directors of the HCDO (Haemophilia Centre Directors' Organisation) had clear knowledge of the risk of AIDS to spouses of haemophiliac patients. Why did these doctors merely decided to monitor spouses, waiting for them to become infected too, instead of informing them as soon as they knew the risks?
In October 1983, how could it possibly be considered ethical for the Medical Research Council to have exploited the fact that the AIDS epidemic in the UK was lagging 3 years behind the USA? Is it not somewhat perverse that the MRC sought to identify opportunities to study haemophilic patients in order to research the virological status of high risk groups BEFORE they encountered the "AIDS agent"? Surely this foreknowledge would have constituted a prime opportunity to save the haemophilic patients from infection?
What kind of doctor, in February 1984 during the AIDS crisis, would lower himself to such a depth as to use the awful choice of words that he was "particularly keen to see part of this product was put into "virgin haemophiliacs"" as part of trials of so-called wet heat-treated Factor VIII conducted on PUPs (Previously Untreated Patients)? Why, at a time when the world was several years into the AIDS crisis and after numerous warnings, do we still find trials being conducted on 'virgin haemophiliacs' or PUPs?
What possessed scientists to conduct an unethical infectivity trial of heat-treated Hemofil-T on infant human beings in a contrasted study against chimpanzees (where 11 out of 13 patients went on to develop non-A non-B hepatitis), as they did in the Colombo, Mannucci et al 'comparative study' published in The Lancet in July 1985?
In 1985, right in the middle of the AIDS crisis, what manner of person would make the following comment.....?
"Of course the maintenance of the life of a haemophiliac is itself expensive, and I am very much afraid that those who are already doomed will generate savings which more than cover the cost of testing blood donations. At this stage I do not want to have your minute or mine copied outside Finance Division." [Quoted verbatim. DHSS Finance Division: FA1. Dated 5th March 1985.]
In 2003, when persons with haemophilia, who were living in the UK, initiated civil litigation against commercial blood product manufacturers and pharmaceuticals companies based in the USA, why did the UK litigants encounter so much difficulty obtaining their medical records from NHS Trusts, and when (or if) they eventually received their medical notes, how was it possible that huge portions were missing; particularly sections relating to the "key" timeframe of 1980-85?
As identified by Carol Grayson in her dissertation, why does the 2006 DOH Self-Sufficiency Report into Blood Products state that the prevailing medical opinion in the 1970s and the early 1980s was that NANBH was mild and often asymptomatic, when Dr Diana Walford, a DHSS doctor, stated in 1980 that 90% of all post-transfusion & blood product infusion hepatitis in the USA and elsewhere was caused by non-A, non-B hepatitis viruses and could be rapidly fatal, particularly when acquired by patients with pre-existing liver disease?
Acknowledgements:
I would like to thank the following individuals and campaign groups for their tireless devotion and hard work in research and document procurement: The Manor House Group, Taintedblood, Carol Grayson of Haemophilia Action UK, the UK Haemophilia Society, Haemophilia Society North West Group and Haemophilia Scotland.