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)

The Biologicals Sub-Committee of CSM recommends that very little is done about the threat of AIDS to haemophiliacs.

• The possibility is considered of withdrawing clotting factor concentrates from the market and replacing them with cryoprecipitate. It is concluded that this is not feasible in the UK on grounds of supply. (Minutes Agenda Point 5.3)

• The possibility is considered of withdrawing US preparations from the UK. It is concluded that this is not at present feasible on grounds of supply. Moreover, the perceived level of risk does not at present justify serious consideration of such a solution. (Minutes Agenda Point 5.4)

In the summary of main points from a consideration of AIDs in relation to licensed blood products by the Committee on Safety of Medicines (Biologicals Subdivision) in July 1983, we read the following:

"There is need for research work on AIDS in the UK, especially in relation to the possible new introduction of this disease into the virgin soil of the United Kingdom.

The Sub-Committee was glad to learn that a number of groups, including the Medical Research Council, are planning and have started research work."

Note: We fail to understand why they talk about the "possible new introduction of this disease". Are we to believe that they somehow helped introduce it to the UK?

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.