(BETA) News Briefs: FDA Approves Access to Thalidomide through Manufacturer

(BETA) News Briefs: FDA Approves Access to Thalidomide through Manufacturer

Bulletin of Experimental Treatments for AIDS, No. 26 September 1995
Ronald Baker, PhD

Celgene Corporation on August 29 announced that FDA has approved a compassionate use (open label) study of thalidomide as a treatment for AIDS-related wasting syndrome. Call Celgene at 800-253-1596, extension 4123 for enrollment information. Under most compassionate use programs, individuals receive an experimental drug free from the manufacturer through their physicians. FDA says it will allow Celgene to sell thalidomide at cost to people with AIDS and wasting. The wholesale cost of the drug will be about $5 per capsule ($140 a month). Celgene says it is necessary to charge for the drug in the compassionate use program due to the company's financial situation. Some AIDS activists are concerned that the cost will significantly restrict access to the drug.

Celgene told BETA that the company will set up an indigent program to provide the drug free to PWA who cannot afford it and are without insurance.

FDA has prohibited AIDS Buyers Clubs from selling and distributing thalidomide imported from Brazil. For several months these clubs have sold the drug to people with AIDS who have prescriptions from their personal physicians.

There are ongoing, FDA-sanctioned clinical studies of thalidomide to evaluate its effectiveness for aphthous ulcers (an ACTG study) and weight loss (a Celgene study) and to gauge its ability to lower the level of tumor necrosis factor (TNF), a naturally occuring cytokine that may increase HIV disease progression when present at higher than normal levels. For information about study locations and entry criteria, call 1-800-TRIALS-A. For more detailed information on the potential benefits of thalidomide in AIDS, see pages 57-58 in the June 1995 issue of BETA.

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Always watch for outdated information. This article first appeard in 1995. This material is designed to support, not replace, the relationship that exists between you and your doctor.

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This information is designed to support, not replace, the relationship that exists between you and your doctor.
©1995. AEGIS.