1. keep an accurate record of each donor's weight and monitor for significant weight loss (Petricciani 1983c).

These advisories constituted an interim measure to protect recipients of blood and blood products until specific laboratory tests became available.

The FDA recommendations for plasma fractionators stated that ''extensive discussions among licensed manufacturers, the Office of Biologics and concerned groups such as the NHF, have led to a consensus concerning an appropriate approach to decreasing the potential risk of transmitting AIDS by certain plasma derivatives." The recommendations included (a) do not fractionate plasma collected from donors at increased risk of AIDS into derivatives already known to have a high risk of disease transmission; (b) use plasma from donors in high-risk groups only for the manufacture of albumin, plasma protein fraction, globulin, or in vitro diagnostic products; and (c) all establishments must label products containing plasma proteins from high-risk donors with "caution, for use in …" (Petricciani 1983c). The memo made the restrictions effective immediately. Although the FDA did not call the recommendations in these letters regulations, blood and plasma collection organizations promptly implemented them (Bove, Perkins, Petricciani, Sandler interviews).

Donor Questioning and Opposition to It

A representative from Alpha Therapeutics, a commercial manufacturer of AHF concentrate, announced at the January 4, 1983, meeting that the company had instituted direct donor questioning designed to exclude high-risk individuals from plasma donation. On December 17, 1982, Alpha Therapeutics had required the exclusion of all donors who had been in Haiti, used IV drugs, or, if male, had had sexual contact with another man. The announcement of this action met with a great deal of opposition from many groups, including the volunteer blood banks and the gay community. These groups took the position that donor sexual preference was a private matter and that the questionnaire was an invasion of privacy. Additionally, Alpha Therapeutics took the position at the January 4, 1983, meeting that AIDS should be a reportable disease, in order to assist in donor screening (Alpha Therapeutics 1994).

Representatives from other plasma fractionation companies also present at the January 4, 1983, meeting discussed the potential threat to the safety of plasma and their manufactured products. One representative from the Pharmaceutical Manufacturers Association stated: "The fractionation industry voluntarily led the way several months ago in designing and implementing donor-processing programs that were aimed at minimizing participation in plasma collection by members of AIDS high-risk groups. By the early part of

The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement