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At a Haemophilia Society meeting, it was discussed that "Dr Owen stated that in 1977 we would be fully self-sufficient in concentrates. The whole question of commercial concentrates, plasmapheresis, the regional structure of the BTS, and other matters were fully discussed."

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A DHSS meeting minutes recorded Dr Owen stressing "his personal commitment to self-sufficiency".

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Dr Owen took Dr Maycock's advice on his criticism of the regional structure of the blood transfusion service which was recorded in Department of Health minutes.

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Dr John Cash wrote to the BMJ stating, "There is no doubt that the import into the United Kingdom of factor VIII concentrates derived from external sources, however well screened for hepatitis viruses, represents an unequivocal pathway by which the level of a potentially lethal infection into the whole community is being deliberately increased."

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Dr Cooper (Assistant Secretary for US Health, Department of Health, Education and Welfare) commented: "We feel that the warning is quite direct and adequate; in fact, it is generally appreciated in the U.S. that every lot of this particular product is probably contaminated with hepatitis B virus."

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Dr Diana Walford stated that "if somebody applied to the Medicines Division or the licensing authority, as they actually were deemed, for a clinical trial certificate or a clinical trial exemption certificate that was to be considered. It fell to be considered by Medicines Division, whether it needed to go entirely to a Committee on Safety of Medicines Meeting I think might have depended on the product."

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It appeared that there was no site examination at any of the blood collection centres in the USA.

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Dr Diana Walford recalled that upon visiting a USA manufacturing facility, the inspector and herself were very unhappy due to the lack of hygiene among other things.

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At the Haemophilia Reference Centre Directors meeting it was suggested the implication was that the cheaper (Kryobulin produced in the US) product carried the higher risk of plasma viral hepatitis which worried some Directors.

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It was mentioned at the Haemophilia Reference Centre Directors meeting that the European (red) material was still available for those who felt it carried a lower risk of conveying hepatitis, although both were equally safe.

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When marketing Factor 8 Concentrates produced from plasma of US origin and the European based material one, no distinction was made between the labelling nor the accompanying information sheets in order for clinicians to pick whichever they wanted to use.

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In an internal memo, Dr Otto Schwarz managing director of Immuno AG stated that two types of Kryobulin would be sold. KRYOBULIN 1, made from European plasma and KRYOBULIN 2, made from US Licensed Source Plasma.

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A table published in June 1983 showed that Immuno Ltd's sales of Kryobulin (Red) exceeded sales of Kryobulin (Blue) by 4.5 times.

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In a memo from Mr Wrigglesworth to Mr Parker and others it was recorded that "Miles Labs state that FVIII manufactured from plasma collected since March 83' will not be available until August, and Immuno in September 83'".

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In her written witness statement to the Infected Blood Inquiry, Dr Diana Waford made reference to the Immuno's ethical obligation regarding American Kryobulin carrying a higher risk of hepatitis.

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In her written statement to the Infected Blood Inquiry, Dr Diana Walford elaborated on the translation of a German note regarding a "publication" showing that American Kryobulin had a higher hepatitis risk.

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It was stated regarding a Hepatitis Survey that all the cases of clinical hepatitis and almost all asymptomatic hepatitis were confined to patients restricted to commercial concentrates. No significant differences between Hemofil and Kryobulin.

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Dr Saad Al-Ismail told the Inquiry that "maybe in retrospect it was probably a misplaced trust in the medicine licensing agency in the UK, in that we never used a product which is not licensed. We never used a product which has not proved to be efficacious."

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Speywood had a product licence to distribute Cutter's Koate, and by February 1980, Speywood later relabelled the Koate product and sold it as Humanate

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Speywood were informed that they could no longer sell relabelled Koate under the brand Humante as the CSM were unable to ensure the safety of the product.

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