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"To no one will we sell, to no one deny or delay, right or justice."
Magna Carta - 15th June, 1215

 
No of entries selected: 3 of 711
1983
22 March
PHLS, J. Craske - Post-AIDS Trials Plans - Involving Previously Untreated Patients
In a draft PHLS letter from J. Craske, Charles Rizza and Arthur Bloom, it is clear that possibly unethical trials of 'Hepatitis Reduced' Factor VIII are still being planned as late as 22nd March 1983:

"You will see that the class of patients to be given these products are those who have had no previous treatment with factor VIII concentrate."

"It is likely that there are only a limited number of these patients in the U.K. who will require factor VIII therapy in any one year. We will be grateful if you notify Dr. J. Craske of any approaches from commercial firms with a proposal to evaluate their product."

Note: This is really damning evidence. It is monstrous that the PHLS are still actively looking for both Previously Untreated Patients (PUPs) and inviting approaches from commercial firms as late as March 1983 in order to expose previously untreated patients to hepatitis for the sake of their trials, especially whilst Dr Craske categorically had knowledge of AIDS from 13th September 1982; at which point, he was tasked with looking into reports of the syndrome in 3 haemophiliacs from the United States where there was the 'remote' possibility that commercial blood products had been involved.

Source: Additional source:
Link #2
(see page 10, final paragraph)
Type: Recovered Document - Craske J, Rizza C, Bloom A. Public Health Laboratory Service (PHLS) letter to Haemophilia Centre Directors. 22 March 1983
Location: UK
1983
4 May
Professor Bloom - Attempt to Reassure the Haemophiliac Community
In a letter to the Haemophilia Society in May 1983, Professor Arthur Bloom attempts to 'reassure' members of the Society about the 'true position' in the wake of 'unduly alarmist' press coverage of the AIDS crisis.

We would like to comment in turn on the following statements made by Professor Bloom:

Bloom: "Haemophiliacs, their parents and doctors have always balanced the quality of life and the dangers from bleeding against the risks of treatment."

Note: TRUE regarding the balancing act. But we would have to state that we were not always informed of the risks, in fact, hardly ever, if at all. We know that trials of 'Hepatitis Reduced' Factor VIII were still being planned as late as 22nd March 1983 (after the UKHCDO suspected the link between AIDS and Factor VIII) and that the PHLS were still actively looking for Previously Untreated Patients (PUPs) and courting approaches from commercial firms in order to expose previously untreated patients to hepatitis for the sake of trials.

Bloom: "The cause of AIDS is quite unknown and it has not been proven to result from transmission of a specific infective agent in blood products."

Note: We must take exception with this based upon documented evidence regarding exactly what Professor Bloom knew or strongly suspected at that time. Professor Bloom was Chairman of the UKHCDO at the 13th September 1982 meeting; which was 8 months earlier. It is minuted on page 10, paragraph 3, that Dr Craske was tasked with looking into reports of the syndrome in 3 haemophiliacs from the USA and that it appeared that there was a remote possibility that commercial blood products had been involved.

Bloom: "In addition the importation of licensed blood products has always been strictly monitored and controlled."

Note: We find this shocking statement to be both inaccurate and misleading. We know from the 11 January 1982 Oxford Letter that Professor Bloom had an excellent understanding of the 'named patient' basis and had discussed plans to request exemption from a Clinical Trials Certificate in respect of individual products in order to expedite trials.

Source: Additional source:
Link #2
Type: Letter from Professor Arthur Bloom to the UK Haemophilia Society. Dated 4th May, 1983.
Location: UK
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1983
before 3rd June
Discussion of Unethical Trials Involving PUPs & Mild Haemophiliacs
In a DHSS background paper on the implications of heat-treated Factor VIII concentrates, we learn that a number of commercial manufacturers are hoping to introduce their heat-treated products and that there is a need for controlled clinical trials of heat-treated concentrates with respect to hepatitis infectivity.

"However, such a trial could pose ethical problems at the present time."

Note: We would like to point out that these clinical trials were being considered at a time that we would describe as the heart of the AIDS crisis. Only 3 months earlier, the PHLS were actively looking for Previously Untreated Patients (PUPs) and inviting approaches from commercial firms (March 1983). We know from documented evidence that the PHLS were strongly considering exposing previously untreated patients to hepatitis for the sake of 'meaningful' trials. This is especially unethical, since Dr Craske (PHLS) had knowledge of AIDS in relation to clotting factors from as early as 13th September 1982.

"In earlier discussions on a protocol for such a clinical trial, Haemophilia Centre Directors had been of the opinion that a meaningful trial could only be conducted in patients who had not previously been treated with Factor VIII ie newly diagnosed mild haemophiliacs. However, this is a particular group of patients for whom the Directors have recommended that only NHS material should be used."

Note: It should be pointed out that only 1 month later, we learn in a DHSS letter to Manchester Regional Transfusion Centre, (July 1983), that 3 chimpanzees went on to develop hepatitis after having been injected with Hyland Factor VIII - which had supposedly been heat-treated.

Source: Link #1
Type: DHSS Paper IV on the Implications of Heat-treated Factor VIII Concentrates. Circa 3rd June 1983.
Location: UK
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