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The British Pharmacopoeia did not contain references the risk of AIDs associated with the use of commercial factor concentrates between 1983 and 1985.
Published on:
23 July, 2024
The CSM declined to grant a licence for Serum Cholinesterase.
Published on:
23 July, 2024
In a memo to Mr Wrigglesworth, Dr Fowler recorded the results of the FDA meeting held on 19 July 1983. The possibility of banning all products made before the FDA's March 1983 Regulations was rejected.
Published on:
23 July, 2024
A. W. Burrell (Managing Director, Travenol) wrote a letter to Dr Walford advising her that "well before" the FDA's 24 March recommendation, Hyland had taken steps to introduce screening procedures designed to eliminate high-risk donors.
Published on:
23 July, 2024
The Haemophilia Society planned a meeting with the junior Minister, Geoffrey Finsberg, to seek his assurance that there would be no immediate ban on the importation of US blood products.
Published on:
23 July, 2024
In a memo to Dr Walford, Dr Oliver (DHSS) expressed the opinion that the assurance from pharmaceutical companies that future sales after June 1983 would comply with FDA guidelines was vague.
Published on:
23 July, 2024
A product licence was granted to Cutter for Factor 8 heat-treated via pasteurisation.
Published on:
23 July, 2024
Between 1970 and 1995 there were 144 Yellow Card reports relating to blood products on the Register of Adverse Reactions maintained by CSM.
Published on:
23 July, 2024
Dr Thomas was invited to speak at a meeting of the Scottish National Blood Transfusion Association.He is reported to have said, "Both the commercial products now licensed had come from factories inspected by DHSS; samples and protocols had been sent to the National Institute of Biological Standards and Quality Control...No British blood product underwent similar inspection."
Published on:
23 July, 2024
Hospital Week reported a special message delivered by President Richard Nixon on Health Care in which he called for a a 'safe, fast and efficient blood collection and distribution system' arising from a general understanding by the authorities that the current system was inadequate; hospitals were often forced to buy blood which came from high risk donors such as drug addicts and derelicts.
Published on:
23 July, 2024
Dr Sheila Waiter noted that, "while it is generally accepted that the benefits of having Hemofil available for the treatment of bleeding episodes far out-weigh the risk of acquiring hepatitis B nevertheless the statement that 'every lot of this particular product is probably contaminated with hepatitis B virus' will come as a surprise to many clinicians using the product".
Published on:
23 July, 2024
Dr Harvey J Alter, Professor Paul Vincent Holland, Robert H Purcell and John L Gerin concluded that that RIA testing, which by then was available, was clearly more sensitive than CEP for revealing Hepatitis B surface antigen.
Published on:
23 July, 2024
Dr Maycock observed that the prevalence of hepatitis in the UK associated with UK blood and blood products had "long been smaller" than that in the US, but added "Until concentrate prepared from UK plasma is available, I would have said the benefits attaching to Hemofil and other similar concentrates of antihaemophilic factor, used with discrimination, outweigh the risk".
Published on:
23 July, 2024
Professor Arthur Bloom expressed concerns to Dr Holgate (DHSS). Firstly that material produced by a US company had been sold "through brokerage or other means" to Speywood where it had been relabelled as a product of their own. A second concern was that it had been reported Inter-Pharma intended to market cut price Factor 8 obtained from Cutter and from Hyland".
Published on:
23 July, 2024
Dr Holgate stated (when responding to the Speywood issue): "As I am sure you are aware one of the cornerstones of our philosophy for the licensing of 'biological' products is to have detailed knowledge of and control over early stages of manufacture and in-process control - this including source material."
Published on:
23 July, 2024
Professor Garrott Allen wrote that "it appears that at least two immunologically separate agents are capable of producing hepatitis from the transfusion of blood or the administration of many of its products". He also added that it was considered that the risk of causing hepatitis from blood taken from paid donors was markedly higher than that of blood from unpaid donors.
Published on:
23 July, 2024
CSM provided a suggested Agenda for discussion on AIDS in relation to licensed blood products which was to be held on 3 July 1983. CSM explained that the discussion was to help them decide if any action was needed in respect of AIDS and licensed blood products.
Published on:
23 July, 2024
The Government announced a 10 million payment for the Haemophilia Society to establish a trust (the Macfarlane Trust). It became a separate charity.
Published on:
23 July, 2024
The National Biological Standards Board was established under the Biological Standard Act 1975 and took over management of the National Institute of Biological Standards and Quality Control ("NIBSC").
Published on:
23 July, 2024
In a paper on the Freedom of Information legislation the CSM had concerns about its secrecy of operation.
Published on:
23 July, 2024
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