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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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The last batch of Koate imported by Speywood was released by DHSS in February 1980.

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Dr Arthur Codd stated that it was known that viruses were transmitted in this way: "we knew there was always a risk there might be other things lurking there" adding that it had always been his advice to create a "pedigree herd" of volunteer donors in order to minimise the risk of infection. A decision was made to import commercial concentrates stating that "We could not have met demand at that time but we could have continued with the older products until Britain became self-sufficient."

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Professor Zuckerman told Michael Gillard that he had visited Immuno in Vienna, and thought it was a poor facility, which lacked medical back-up and had "dubious sources of plasma".

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The New England Journal of Medicine carried an article suggesting the recorded cases of the principal symptoms included in the syndrome might only represent the tip of the iceberg in terms of the prevalence of conditions associated with AIDS.

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It was reported to the World Congress of Blood Transfusion (Budapest) that is was suspected in the US that an infective agent in blood concentrates resulted in people with haemophilia dying of AIDS.

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