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The Sub-Committee on Biological Products stated that on grounds of safety, quality and efficacy it was unable to recommend that the Product Licence be varied for Travenol Laboratories Ltd Hemofil product. It considered that justification should be provided for the inclusion and choice of the heat treatment step and that there was inadequate evidence as to the safety and efficacy of the product.
Published on:
27 August, 2024
CDC Epidemiological Notes and Reports Update on Kaposi's Sarcoma and Opportunistic Infections in Previously Health Persons documented that of the 355 cases reported then, 16% were heterosexual - and a quarter of these were women. Only about half were intravenous drug users.
Published on:
27 August, 2024
The FDA wrote to manufacturers of plasma products to tell them that "although the cause of this outbreak is unknown, the information suggests that a transmissible agent might be involved and concern about transmission through blood and blood products has been raised."
Published on:
27 August, 2024
The National Hemophilia Foundation broke the news to its members that the CDC believed that the immune deficiency might be caused by a virus transmitted through blood or blood products as was hepatitis, but advised that the risk of contracting this immunosuppressive agent was minimal.
Published on:
27 August, 2024
Dr Steven Ojala of Cutter wrote after one meeting in January 1983, quoting a colleague from Hyland, that 'it is unusual for us [the commercial companies] to come away wearing the white hats while the "volunteer" sector wears the black'
Published on:
27 August, 2024
Individual clinicians, gay rights groups, and the National Hemophilia Foundation all joined calls at various stages to obtain more information before taking steps or "stigmatising" donors or users of blood products.
Published on:
27 August, 2024
The California Morbidity and Mortality Weekly Report confirmed that the three people with haemophilia whose cases had been reported in July 1982 had all died
Published on:
27 August, 2024
During a Centers for Disease Control (CDC) meeting, Dr Francis slammed his fist on the table and asked in effect how many AIDS cases, or how many deaths, would be needed before those attending took action.
Published on:
27 August, 2024
In the 1997 Krever Report Mr Justice Krever summarised the Centers for Disease Control (CDC) meeting of January 1983 by noting "there was no consensus on the question whether AIDS was caused by a transmissible agent, on the risk of AIDS from blood donations, or on the desirability of introducing new methods of donor screening or testing to reduce the risk of transmission."
Published on:
27 August, 2024
Recommendations were announced by the US Public Health Service on 4 March 1983, when their principles were endorsed by the American Red Cross, the American Association of Blood Banks, and the Council of Community Blood Centers.
Published on:
27 August, 2024
The US Public Health Service announced recommendations for the prevention of AIDS in patients with haemophilia and for other recipients of blood and blood products so that a uniform set of recommendations might be developed.
Published on:
27 August, 2024
Documents recorded that it was estimated that prison plasma accounted for approximately 2% of the total plasma collected in the US as of mid 1982 and was obtained from no more than six to eight centres.
Published on:
27 August, 2024
Dr Clyde McAuley, Alpha's medical director, was quoted as saying "So long as there is any question about the involvement of blood products, Alpha is taking all possible steps to reduce the potential risk for the hemophiliac receiving our factor VIII and factor IX concentrates."
Published on:
27 August, 2024
By the summer of 1983, 800 potential donors had "voluntarily disqualified themselves from the pool."
Published on:
27 August, 2024
Alpha's insistence on the measures taken pertaining to high-risk donors meant that they lost contracts with some blood banks that sold recovered plasma as they were not prepared to implement them.
Published on:
27 August, 2024
The American Blood Association made a public statement accepting that the cases of AIDS in people with haemophilia "suggest that AIDS may be of infectious etiology" and the organisation urged that "steps be taken as soon as possible to screen plasma donors to minimize the possibility of transmitting AIDS."
Published on:
18 October, 2024
Anti-HBc testing came to be regarded, and argued over, as the most likely surrogate test as the epidemiological pattern of AIDS was considered to be similar to that of Hepatitis B.
Published on:
27 August, 2024
Recommendations by the National Hemophilia Foundation's Medical and Scientific Advisory Committee were for the "Evaluation and implementation (if verified) of surrogate laboratory tests that would identify individuals at high risk of AIDS transmission."
Published on:
27 August, 2024
Dr Ojala of Cutter sent a memo to Whilhelm Schaeffler noting that the time had come for hepatitis core anti-body testing for plasma.
Published on:
27 August, 2024
The Hepatitis B Core Antibody Testing Group published an interim report in March 1984 and a full report in July 1984, and deemed that testing was not necessary.
Published on:
27 August, 2024
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