The taintedblood Timeline - what really happened...
Dr Cash: "We are particularly keen to see part of this product is put into "virgin haemophiliacs" and would much appreciate the assistance of the U.K. Haemophilia Centre Director's Working Party on Hepatitis."
Note: This letter makes very upsetting reading. At the time this letter was written, February 1984, they were several years into the AIDS crisis. There had been numerous warnings (from the CDSC to the 1983 FDA regulations) yet, we still find trials being conducted on PUPs or as this letter so horrifyingly words it 'virgin haemophiliacs'.
These Doctors knew that there was no cure for AIDS.
"Following your letter on your requirements for "virgin" haemophiliacs in Scotland and Northern Ireland, I tried to contact you by telephone last Thursday in order to begin supply as soon as possible. As you were down in London it was obviously difficult!"
"Provided that you were agreeable and that the patients met the criteria, and given agreement by the Haemophilia Directors involved, Jim can provide 8Y from batches set aside for trial purposes."
On page 2, there is a disturbing revelation regarding the status of the source material:
"There is one point, however, that you need to consider. Current batches of 8Y on issue, are not made from certified anti-HIV screened donations. The first individually screened product will not be released for issue until August.
Subsequent batches will all be made from screened plasma. In light of press statements from Armour Pharmaceutical, and rumours from the Haemophilia Service this may have implications for both laboratories. In addition, two parliamentary questions have been submitted on this problem relation to both Elstree and PFC. A written DHSS reply was due today."
In a further letter of 24th July, we can see that BPL are confirming the supply of 50 vials:
"I have now confirmed that BPL are happy to supply 50 vials of 8Y to PFC on the understanding that, in the event that the material is used in suitable virgin patients, appropriate serial samples would be taken to contribute to their overall infectivity study."
Note: Until this discovery, we had wrongly thought that the evidence relating to the use of "virgin" haemophiliacs was limited to Scotland (specifically, the Dr John Cash letter of 17th February 1984 - see Related Links below). However, due to this letter, we can see that the horrors of trials involving "virgin" haemophiliacs have been brought right home to BPL, England.
NANB Transmission in Virgin Haemophiliacs:"Could you let me know the batch of FVIII involved in the transmission of NANB Hepatitis to Dr Ludlam's virgin patient. While this outcome of treatment is not surprising we need to know the batch number and dose to keep our surveillance cross referencing records complete."
Type: Penrose Evidence File
Find related entries
"The strongest evidence on the magnitude of risk of viral transmission from any particular product is derived from 'Virgin Patient' (VP) studies, of which there have been relatively few. It is generally considered that at least 60 patients with uneventful follow-up are needed to satisfactorily prove safety at the 95% level of confidence. To our knowledge, no studies yet carried out have fulfilled this criterion." (page 2, paragraph 1)
Of the products available, or soon to be available in May 1988, there were 8 which were unlicensed and should only have been used on a 'named patient' basis, whilst another 8 products had already been used in 'virgin patient' studies.
Background: In complete contrast to these 'recommendations' for the continued use of plasma-derived factor VIII products, Hyland, in 1987, had already commenced human clinical trials of recombinant Factor VIII concentrate. (Source: Baxter Vaccines - Milestones. See below for link.)
Note: If the UK Haemophilia Centre Directors had genuinely wanted to protect their patients from further risk of viral infection, they would have overcome their fondness for 'virgin patient' studies and directed their need for unlicensed products toward early recombinant trials. After all, we know from a DHSS memorandum that the technology for genetically-engineered factor VIII was known about as early as September 1983.
All rights reserved