The taintedblood Timeline  -  what really happened...

By 3rd of March, 1983, there were eleven cases of acquired immunodeficiency syndrome (AIDS) in haemophiliacs who had all received factor VIII concentrate. These cases had been reported to the CDC in the USA.

By 30th April, 1983, a letter, entitled: 'Factor VIII Products and Disordered Immune Regulation' was published in the UK in The Lancet by Dr Robert S. Gordon, Jr. of the National Institutes of Health (NIH), Bethesda, USA. The letter stated:

"These observations are consistent with the hypothesis that AIDS is caused by a transmissible agent, presumably a virus, that can be included in blood products, and that some recipients of the agent have not (at least not yet) developed the complete clinical syndrome with its devastating complications."

"These alternative hypotheses might be distinguished through a study of T-lymphocyte subpopulations among similarly treated haemophiliacs in a geographical area to which AIDS has not yet been introduced. The resolution of this question by a timely investigation in some country, where cases of AIDS have not yet been reported would be an immense help to public health workers worldwide. In this situation "negative results" would be of great significance."

NOTE: Please click the 'Find Related Entries' link below to see how this Timeline entry relates to the one for 10th October 1983 regarding the Medical Research Council. It appears that Dr Gordon's letter somehow managed to engender a controlled AIDS study of UK Haemophiliacs; the Edinburgh Haemophiliac Cohort; a study which we believe to have been entirely unethical. TaintedBlood has members who have testified at the Archer Inquiry where they expressed belief that their infections where acquired as a result of this study. (see 2nd link below)

In a specially convened meeting of the Haemophilia Reference Centre Directors on 13th May 1983, the Physicians present, (including Dr Diana Walford observer for the DHSS), fail to take any action over the threat of AIDS to haemophiliacs:

"It was agreed that there was insufficient information available from the U.S. experience to warrant changing the type of concentrate used in any particular patient. Moreover once the condition is fully developed it seems to be irreversible so that there would seem to be no clinical benefit to be gained by changing to another type of factor VIII." (page 2, paragraph 2)

"With regard to general policy to be followed in the use of factor VIII concentrates, it was noted that many directors have up until now reserved a supply of National Health Service concentrates for children and mildly affected haemophiliacs and it was considered that it would be circumspect to continue with that policy. It was also agreed that there was, as yet, insufficient evidence to warrant restriction of the use of imported concentrate in other patients in view of the immense benefits of therapy." (page 2, paragraph 3)

Prior to this meeting, physicians should reasonably have known the following:

• As early as 13th September 1982, Dr J. Craske was tasked with looking into reports of the syndrome in 3 haemophiliacs from the United States, and he suspected a remote possibility that commercial blood products were involved.
• On 15th January 1983, there had been an article in the Lancet by Dr Jones (a member of the UKHCDO) where AIDS had been linked to common cell immunity in haemophiliacs.
• By March 1983, the Directors of Haemophilia Centres were requested to report any cases of AIDS in haemophilia patients to the Oxford centre, to then be relayed to the Communicable Disease Surveillance Centre.
• On 23rd March 1983, in the USA, FDA regulations for the collection of plasma excluding donors from high-risk groups were introduced. However, use of pre-March 1983 stock was unfortunately NOT banned due to supply concerns.
• On 6th May 1983, the UK's CDSC telephoned the DHSS to inform them that a 23 year old haemophiliac patient from Cardiff was now showing symptoms of an AIDS diagnosis after having been infused with US Factor VIII.
• On 9th May 1983, the CDSC had written a crucial letter recommending that American FVIII should be withdrawn from use due to the risk of transmitting AIDS.

At a Council of Europe meeting in Lisbon (16-20th May 1983), a draft resolution is accepted recommending that the use of coagulation factors prepared from large plasma pools should be avoided except where such a product was specifically indicated for medical reasons.

The terms of the recommendations are as follows:

• To take all necessary steps and measures in respect of AIDS.
• To avoid the use of coagulation factor products from large plasma pools, except when such a product is specifically indicated for medical reasons; this is especially important for those countries where self-sufficiency in the production of such products has not been achieved.
• To inform attending physicians and selected recipients, such as haemophiliacs, of the potential health hazards of haemotherapy and the possibility of minimising these risks.
• To provide all donors with information on AIDS, so that those in high risk groups will refrain from donating.
• To pursue rapid and full implementation of recommendations of R(80)5 and R(81)14.

In an informal report on the Council of Europe Committee of Experts on Blood Transfusion and Immunohaematology, Dr H. Gunson presents the following extracts in relation to Acquired Immune Deficiency Syndrome (AIDS):

• The significance of AIDS to the Committee was in relation to the effects with respect to the transfusion of blood and blood products, particularly with coagulation factor concentrates given to patients suffering from haemophilia. Absolute proof that AIDS is cause by a transmissible infectious agent is not yet available, but the consensus in the Committee was that it should be regarded as such that a recommendation should be made to the Council of Ministers at the meeting in June to take necessary steps to minimize the transmission of AIDS by the transfusion of blood products. (page 1, paragraph 4)
• With respect to the importation of plasma products, particularly from the USA, I find it difficult to believe that these can be phased out in the near future, since the Haemophilia Directors have always maintained that they require up to 100 per cent more Factor VIII for the treatment of haemophilia than can be produced from BPL. No doubt the opinion of the CBLA will be sought on these aspects. (page 2, point 4)
• It is important, I think to avoid "emotive over-reaction" amongst recipients, a phrase which will also appear in the recommendations. (page 2, final paragraph.)
• As will be evident from the above, the implications of AIDS in various aspects of blood transfusion practice kept appearing. Undoubtedly it is an important disease with a high mortality rate which has attracted considerable press publicity. Whilst it has not yet reached proportions in Europe as it has in the USA many members of the Committee considered that we may be seeing the beginnings of a problem which could escalate if appropriate steps are not taken now. (page 3, final paragraph)

In a "Chronology - Blood Products/Haemostatic Agents and Hepatitis C/NANBH" submitted to court to assist the Judge, Professor Geoffrey Savidge listed the following:

Internal Correspondence from DHSS - Diana Walford dated 6 June 1983. Under the general heading "Possible Implications of AIDS for Plasma Supply and Manufacture at BPL:

"There are increasing indications that the AIDS may be transmitted by blood and blood products. Because of the number of donations to which they are exposed, haemophiliacs receiving large pool factor VIII concentrates (such as that manufactured at BPL) might be at greater risk than those receiving single donor cryoprecipitate or small pool products. At a recent Council of Europe meeting (16-19 May 1983) a draft resolution was accepted which recommends that the use of coagulation factors prepared from large plasma pools should be avoided except where such a product is specifically indicated for medical reasons. The implication in the resolution is that there should be greater use of single donor or small pool products."

Note: We have been unable to find this internal correspondence of 6th June 1983 in any of the FOI releases. We have also been unable to identify it in the evidence submitted to the Penrose Inquiry, and there is no mention of it in either the Preliminary Report or the Final Report. Therefore, we question whether it was ever released? ...

In an DHSS circular of 13 June 1983, it is evident that as much as 50% of the Factor VIII material required for the United Kingdom is large-pool imported commercial concentrate, mostly from the USA.

NHS single-donor cryoprecipitate	17%
NHS large-pool FVIII concentrate	33%
Imported large-pool (mostly USA) FVIII concentrate	50%

The DHSS circular continues:

"From these figures it can be seen that there is no option but to treat the majority of our haemophiliacs with large-pool products and thus it could be argued that the use of such products is specifically indicated for medical reasons since the risks of non-treatment are greater than the risks of treatment. However, this is a rather dubious 'let-out' and I think we should prefer to see the recommendation re-worded viz:"

• To avoid wherever possible [practicable] the use of coagulation factor products prepared from large plasma pools: this is especially important for those countries where self-sufficiency in the production of such products has not been achieved.

"On the latter point, the implication is that the need to avoid large-pool products may be lessened if a country is self-sufficient in blood products."

It is clear from these comments that there were attempts within the DHSS at 'skin-saving' and possibly cost-cutting apparently designed to mitigate or even circumnavigate the draft recommendations of the Council of Europe.

(See Related Entries link below for an astounding Kenneth Clarke comment made only 5 months later.)

In the Minutes of the CBLA (Central Blood Laboratories authority), Central Committee for Research and Development in Blood Transfusion, held on 21 June 1983, we can learn more about when the DHSS actually started to make the link between AIDS transmission and blood and blood products:

"The Chairman outlined the problems caused by AIDS. Since it appeared to be transmitted through blood and blood products then it should be considered by the Committee."

Note: We note that Dr Diana Walford (on behalf of the DHSS) was present at this meeting.

In an October 1983 meeting of the Medical Research Council, the Chairman, Dr Tyrrell, indicated the need to ensure that the best use be made of the special combination of suitable patients for study and the clinical, immunological, virological and other expertise that was available in the United Kingdom:

"The special features arising in relation to haemophilia were discussed and the possibility of identifying the role of imported Factor VIII concentrate used for UK patients was outlined. There followed discussion on the varying and considerable period of incubation (1 to 4 years) and the possible relationship between the size of inoculum of the PROPOSED AGENT and the length of latency." (page 2, point 3a, line 14)

"It was noted that blood product associated cases could enable some of these alternative hypotheses to be tested." (page 3, end of paragraph 4)

O"pportunities Special to the United Kingdom:"
"The Working Party sought to identify particular opportunities for research unique or special to the United Kingdom. The fact that the epidemic was lagging some three years behind that in the USA was considered an important factor in enabling the background against which AIDS develops to be delineated. This could enhance our ability to detect the emergence of AIDS and virological status of the high risk groups. The underlying immunological and virological status of the high risk groups BEFORE they encountered the "AIDS agent" could thus be defined." (page 4, point 4)

"The UK system for haemophilia treatment and for blood product organisation would allow detailed study of haemophilia associated cases which has not been possible in the USA due to their system of record keeping and organisation." (page 4, end of paragraph 3)

"The organisation of epidemiology in the United Kingdom was well suited to studying this problem. The importance of establishing such studies early in the emergence of disease was again stressed." (page 4, final paragraph, line 5)

"It was noted that in addition the UK offered particular opportunities to pursue carefully controlled and monitored therapeutic trials." (page 5, paragraph 2)

"It was thought that suspect blood products could provide valuable raw materials for work of this type. Indeed, the possibility of fractionating blood from patients with "pre-AIDS" in order to concentrate the agent was a notable suggestion."� (page 5, paragraph 4, line 10).

Batch History of FVIII Batch No. 023110090 Associated with HIV Transmission to SHS Haemophiliacs:

"This batch was associated with the transmission of HIV to approximately 15 Edinburgh Haemophiliacs. The details of these seroconversions have been extensively reported in the literature of Dr Ludlam."

"FVIII Batch No 023110090 was manufactured in November 1983 from plasma collected in the Autumn 1983. Clearly this preceded the availability or introduction of plasma donation testing or product treatments to inactivate HIV (eg heat treatment) either in the UK or internationally."

"Following the reports of product infectivity, attempts were made to identify the specific donation(s) which led to the product being infective. These were unsuccessful."

"Attached is a summary of the action taken by Dr McClelland and Dr Cuthbertson to effect a batch recall after initial notification by Dr Ludlam of seroconversions."

"Batch No 023110090 was in all other respects compliant with the product specification at that time and there were no notable events during the manufacturing process."

NOTE:

Please click the 'Find Related Entries' link below to see how this Timeline entry relates to the one for 10th October 1983 regarding the Medical Research Council (MRC) and what should be referred to as a controlled AIDS study of UK Haemophiliacs; the Edinburgh Haemophiliac Cohort; a study which we believe to have been entirely unethical.