Heat-treated Factor VIII and Factor IX produced by Bio Products Laboratory (BPL) in the mid 1980s were evaluated in several haemophilia centres in England and Wales. The results from these studies have been published by the investigators in medical journals.
BPL developed 8Y in 1985 and studies on the efficacy of BPL’s heat treatment undertaken after 1986 showed that the process was very efficacious. Clinical trials and laboratory studies reported in 1985 had previously demonstrated the safety and clinical efficacy of the heat-treated product made by the Plasma Fractionation Laboratory of Churchill hospital Oxford, which was destined to become the BPL heat treated factor VIII product (8Y).
The report “Self Sufficiency in Blood Products in England and Wales” provides a section on heat treatment which contains information on trials undertaken by a number of commercial companies. The supporting references are all in the public domain.
(2) by what date she expects her Department to finish its identification and review of all the documents currently held relating to the safety of blood products between 1970 and 1985; and if she will make a statement.
[holding answer 19 March 2007]: The report on the internal review of documents held by the Department relating to the safety of blood products between 1970 and 1985 is being finalised. This report will also take account of missing documents. We expect to complete the report shortly, and a copy will be placed in the Library.
The internal audit report will be referenced in the internal review of documents and we will make all reference documents available.