AEGiS-GMHC: The FDA and Underground Thalidomide

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

The FDA and Underground Thalidomide

Treatment Issues; Vol. 9, No. 5 - May 1995
Brett Lowell

Last Fall, the Food and Drug Administration warned AIDS buyers' clubs not to provide access to thalidomide to people with AIDS-related wasting. Taking the FDA pressure under consideration, the PWA Health Group in New York and Healing Alternatives in San Francisco have set up an "Underground Thalidomide Compassionate Use Program" to cautiously provide regular access to the drug. To get thalidomide through this program a person must 1) have a prescription, 2) have read and signed a booklet on how to use thalidomide safely and 3) agree to return any unused medication. The program will only provide a ten-day supply of thalidomide at a time. Since thalidomide might mask the TNF-associated symptoms of other diseases, the buyers' clubs caution that people with AIDS taking thalidomide be regularly monitored for tuberculosis and MAC.

Despite the precautions and great care that the buyers' clubs have taken in designing this program, the FDA called the buyers' clubs on May 9 and again warned them not to sell thalidomide.

The buyers' clubs have set up a meeting with FDA officials for the third week of June. Sally Cooper, executive director of the PWA Health Group, says that if all of their work provoked the FDA into promoting an official compassionate use program for AIDS-related wasting, their mission would have been accomplished.

The PWA Health Group may be reached at 212/255-0520 for further information on the thalidomide program's status. Healing Alternatives' telephone number is 415/626-2316. --TS

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