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Dr Smith was concerned that the few blood product recipients who had not already been infected with hepatitis might be engaged in testing other products to establish, for licensing authorities considering the grant of licences in respect of those products, whether they did, indeed, reduce non-A non-B Hepatitis as claimed.

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Dr Smith said that PFL/BPL had elected to try dry heating of an existing product, 8CRV. In the proposal he recognised "our late start."

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"The Lancet" published an article which in its summary said that the findings reported in it "support the possible role of retroviruses in AIDS, and indicate that factor VIII concentrates must be heated to inactivate these infectious viruses."

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Dr Lane wrote to Dr Edmund Harris at the DHSS to notify him of his plan to dry heat all the Factor 8 to be produced "on the empirical basis that it has a satisfactory process efficacy for inactivation of HTLV-III."

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Dr Harris asked Dr Lane to refer his plan to an advisory group to consider if the evidence for inactivation of HTLV-3 by heat was "sufficient to warrant" taking such a step, "particularly if a screening test can be made available."

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Dr Lane reported promising trials of a heat-treated product to the CBLA Central Committee for Research and Development in Blood Transfusion and that the time scale for the new product he had in mind ("8Y") was a year.

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Dr Lane's team gave him a "very provisional" date of 1 April 1985 for the implementation of heat treatment, and said it was "impossible to judge its feasibility."

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Dr Smith told Dr Lane: "US companies say they can provide UK with more than enough heated product, today."

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Dr Smith told Dr Lane: "Anything going into PFL's oven on 11th December will not be issuable until January", and asked if there should be an interim policy on the issue of "what little dry-heated 8CRV we already stock?"

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In an editorial "The Lancet" said that the time had come when it was now reasonable to switch to heat-treated products.

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Cutter and Alpha both published the results of tests which showed that their heating processes had inactivated HTLV-3/HIV virus load to a degree sufficient to show they were almost certainly (generally) safe, and the use of heat-treated product had been strongly endorsed by "The Lancet".

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Dr Snape wrote to the haemophilia centre directors to inform them that "limited supplies" of a heated Factor 8 concentrate would be available in early February and that would be "the product generally available for the next three to four months, the amounts being 50-60% of what would otherwise have been supplied as unheated concentrate."

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BPL had started to heat treat its Factor 8 and "limited amounts will be distributed to the National Health Service for clinical trials within the next two weeks. Heat-treatment capacity is being increased, and it is hoped that, by April this year, all BPL factor VIII will be heat-treated."

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Dr Snape wrote to Dr Lane: "a significant number of HTLV-III Christmas disease patients, treated only with NHS IX and with no other risk factors, argues strongly for haste with manufacture of heated factor IX."

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BPL were in a position to issue information sheets which stated that the clinical trials of 8Y at six haemophilia centres showed that several patients had by then safely passed the point at which the first evidence of non-A non-B Hepatitis viral transmission would normally occur with non-heated Factor 8.

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BPL and PFC recalled unheated Factor 9 in October 1985.

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Dr Harris of Armour wrote to haemophilia centre directors recommending the return of all non-donor tested Factorate so that it could be exchanged for material manufactured from screened donations.

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An internal Cutter memo showed that all heat-treated product made commercially carried a significant, though reduced, risk of hepatitis. None had been eliminated.

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The Committee on Safety of Medicines considered the safety of heat-treated Factor 8.

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Dr Peter Fernandes accidently discovered an appropriate stabiliser and by December 1978 had moved on to show those which worked with the globulin could work with antihaemophilic factor.

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