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In a publication Dr Alter and Dr Leonard Seeff made reference to a study conducted in Germany, which measured the impact of adding anti-HBc testing to the screening of a population already tested for ALT. It showed that recipients of anti-HBc positive blood had a five-fold greater risk of developing post-transfusion hepatitis than recipients of blood testing negative.

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Dr Cash asked Dr Gerald Sandler the outcome of the FDA's deliberations and whether the American Red Cross had decided to introduce routine anti-HBc testing of donations.

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Dr Gerald Sandler informed Dr Cash that the American Red Cross had not changed its approach to donor testing but would review whether to introduce anti-HBc/ALT donor testing imminently.

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Dr Brian McClelland stated he would provide data on raised ALT levels in blood donors by Autumn 1986. The SNBTS directors agreed to consider funding

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Dr Forrester appeared sceptical about the introduction of surrogate screening which was reflected in his note on SNBTS Directors' meeting where he commented that there was "no justification for panic measures."

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Dr Forrester asked the Communicable Diseases Surveillance Unit in Glasgow for information on the likely incidence of NANBH in Scotland, the proportion of NANBH attributable to blood transfusion or administration of blood, and how far any proposed test could reduce this proportion.

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A journal article reported an association between anti-HBc and NANBH and that a high percentage of NANBH patients develop chronic hepatitis. It concluded that if surrogate screening could prevent approximately one third of transfusion-associated cases of NANBH, this could represent an annual reduction of 50,000 cases of hepatitis and 2,500 cases of cirrhosis in the US.

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The Statistics Expert Group's Report stated that post-transfusion HCV infections could not be properly estimated before reliable tests were adopted in the early 1990s, and so estimates of the number infected, when based on pre-1990 studies, needed to be treated with great caution.

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The Regional Transfusion Directors' meeting agreed that a study on NANB Hepatitis should not be carried out because of lack of time and resources.

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Dr Contreras wrote to the DHSS saying that a study of anti-HBc in British blood donors should be undertaken.

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Dr Contreras stated in her oral evidence that the pressure to introduce screening was from the liver disease specialists and the Haemophilia Centre Directors

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Dr Contreras stated in oral evidence she felt it was taking too long to secure funding for a study into surrogate testing

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Dr Contreras stated, upon reflection, she had underplayed the risk of NANBH when writing to Dr Barbara in 1987

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Dr Contreras expressed the view changed for Medicines Control Agency (MCA) from 'maximum benefit at minimal cost' to 'if a measure reduces risk, we should take it' and that she shared this change in view in 1991.

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Mr Justice Burton expressed the view that if a measure would prevent or reduce risk, it should be taken unless the disadvantages outweigh the advantages.

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It was argued during the case that the ALT tests were relatively inexpensive. Mr Underhill QC expressed that cost was not a factor in either ALT testing or anti-HBc testing.

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It was Dr Gunson's belief in the 1980s that the risk of infection was 3% for post-transfusion NANBH

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Mr Justice Burton assessed that the introduction of ALT and anti-HBc testing would have lost 2.5% and 4% of donations respectively but this would have been countered by the moving surplus blood supplies to centres in need. He believed there would not be a major shortage as Dr Gunson had described in 1991.

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Mr Justice Burton concludes that the idea of reducing donor numbers that were unwanted was never discussed by ACTTD or ACVSB and neither ALT or HBc testing overlapped. They should have introduced surrogate testing before 1 March 1988.

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Dr Gunson was a proponent of the minimum risk to maximum safety concept and concurred with both the opinions of Dr Barbara and Dr Contreras

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