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Increases in demand for blood products in the 1970's and limitations on domestic supply and regulation resulted in American companies seeking blood and plasma from what were then low-income countries.

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Plasmapheresis centres supplied US companies from Nicaragua, Mexico, Belize, the Dominican Republic, Costa Rica, El Salvador, Colombia and Haiti.

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American companies established their own plasmapheresis centres along the southern border of the US so that Mexicans could access them on foot, importing the donor rather than the donation.

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President Nixon ordered the US Department of Health, Education and Welfare to make an intensive study of better ways to manage the American blood supply.

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The US Government decided to transfer responsibility for regulation of the blood industry from the Division of Biological Standards to the Food and Drug Administration, which led to the possibility of greater intervention and inspection from a better resourced regulator.

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There were approximately 7,000 blood and plasma centres in the United States.

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Douglas Starr quoted Professor Zuckerman as describing a Hyland facility in Los Angeles as "an offense to human dignity".

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Cheaper imported plasma formed the basic material for concentrates distributed into 1977 and 1978.

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The UK was a marketplace for five main commercial Factor 8 products: Hemofil - manufactured by Hyland Therapeutics, Kryobulin - manufactured by Immuno AG, Profilate - manufactured by Abbott Laboratories and then by Alpha Therapeutic Corporation, Factorate - manufactured by the Armour Pharmaceutical Company, and Koate - manufactured by the Cutter Laboratories Inc.

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Kryobulin and Hemofil, the first products to be licensed for use in the UK, were the subject of a one year central contract for ten million international units between the UK companies importing them and the Department of Health and Social Services and Welsh Office

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The levels of onward purchase by regional hospital boards both for Kryobulin and Hemofil were not as expected.

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Sales figures for the year ending October 1976 showed that Hemofil and Kryobulin were the most used products, followed by Factorate and Profilate.

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Survey of commercially-produced and NHS-produced Factor 8 concentrates refers to Hemofil, Kryobulin and Profilate as three main products licensed in the UK.

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Profilate HT gained market share as a consequence of growing confidence that its technique of "wet heat treatment" reduced, although did not eliminate, the risk of infection with non-A non-B Hepatitis as well as inactivating HIV.

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Profilate licensed with the following warning: "This product is prepared from units of human plasma which have been tested and found nonreactive for Hepatitis Associated Antigen. However, it is recognized that presently available methods are not sensitive enough to detect all units of potential infectious plasma and the risk of transmitting hepatitis is still present".

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Over the years the text of the Profilate warning was amended to take account of changes to screening tests, but the final sentence remained unchanged.

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Profilate HT was provided on a named patient basis in the UK

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The licensing authority required references to heat treatment to be that it was intended to "reduce the risk of transmission of infectious agents" rather than making claims about it reducing the risks of HIV or non-A non-B Hepatitis by name.

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In terms of the distribution of market share for commercial Factor 8 products, Factorate accounted for 42%, Koate for 18% and Profilate and Kryobulin both accounted for around 11% of total usage.

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Armour,/Alpha, Travenol/Hyland, Miles/Cutter and Immuno all confirmed that their plasma came from plants that were licensed by the FDA and that the origins of their plasma were identifiable

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