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The CDC published a report on "Immunodeficiency among Female Sexual Partners of Males with Acquired Immune Deficiency Syndrome (AIDS)".

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I Marshall, of Alpha Therapeutic, wrote to Professor Bloom in relation to AIDS and precautionary steps being introduced to minimise the risk of the disease being transmitted via donors to people with haemophilia, including donor screening and leafleting.

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Lederman et al published a report in the New England Journal of Medicine titled "Impaired cell-mediated immunity in patients with classic hemophilia".

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It was asserted in a meeting with Immuno that "it is not known if AIDS is caused by a virus or an attacker inimical to T cells".

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People with haemophilia who were without symptoms of HIV but who had received factor concentrates had abnormalities in their T cells, but those who had received cryoprecipitate did not.

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Medical News published an article entitled "Preventing AIDS transmission: should blood donors be screened?" reporting on the connection between AIDS and the infusion of blood and blood products.

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The Centers for Diseases Control published an article in its Morbidity and Mortality Weekly Report, which reported over 1,200 cases of AIDS from 34 states since June 1981, explained statistics and made reference to the parallel between AIDS and Hepatitis B.

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According to Dr Kingdon, the United States plasma collection centres tended to be located near areas where there was likely to be a population willing to spend 2-3 hours donating plasma for a small payment (near universities, army bases and in the lower socio-economic sections of a city).

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The size of pool used by Hyland/Travenol appears to have increased over time as, in his draft statement of 1990, Dr Kingdon referred to "start pool" sizes of up to 15,000 donations. He did not provide further details of when, how and why the pool size had changed.

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Dr Kingdon recorded that:"All importation stopped following the FDA direction that source plasma and the centres producing source plasma be licensed; the FDA would not inspect offshore sites which meant that imported plasma would not be approved plasma and therefore could no longer be used in the manufacture of blood products. As a result, since approximately 1978, all plasma used for the production of concentrates in the United States has been obtained from donors in the United States."

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There was a single centre in Belize, which was also licensed for fractionation (and hence should have been inspected) by the FDA.

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A meeting was held at the National Institute for Biological Standards and Control ("NIBSC") between civil servants, American and British fractionators, clinicians and scientists. Among the issues discussed was the size of donor pools.

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At an NIBSC meeting the National Hemophilia Foundation's position that products should be automatically recalled where a donor was diagnosed with AIDS or characteristics strongly suggestive of AIDS was explained.

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The WHO Resolution urged Member States to promote national self-sufficiency on the basis of voluntary donations and to "enact effective legislation governing the operation of blood services and to take other actions necessary to protect and promote the health of blood donors and of recipients of blood and blood products."

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A letter sent by the US Assistant Secretary for Health to the UK Chief Medical Officer, confirmed that "Source plasma used in manufacturing licensed plasma derivatives, in the US or overseas, must be collected in facilities with US licenses."

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Dr Cooper indicated that he would be interested in the views of Dr Yellowlees both on the labelling of the products and the "benefit-to-risk considerations".

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Dr Cooper stated stated that "Source plasma collected outside the U.S. and shipped to overseas consignees manufacturing products not licensed by us are not subject to any U.S. regulations."

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The Krever Report notes that by March 1982, 257 cases of PCP or Kaposi's sarcoma (including 25 of both) had been linked to immunosuppression (demonstrated by a reversal of the usual T-helper/suppressor ratio) and identified to the CDC task force.

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The Krever Report recorded that "In the autumn of 1983 and early 1984, U.S. fractionators added warnings about the risk of AIDS to the information in the product inserts - Armour, for its factor VIII concentrate, in October 1983; Cutter, for its commercial factor VIII concentrate, in January 1984; and Hyland, for its factor VIII concentrate, in March 1984."

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A committee on opportunistic infections in patients with haemophilia in the US met to exchange information about the cases and to conduct surveillance. At its second meeting in Washington DC it was agreed that the possibility must be explored and that techniques should be developed immediately to reduce or eliminate the risk of infection from Factor 8 concentrates.

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