Document 0654
 DOCN  M9590654
 TI    Thalidomide, the FDA, and us -- what do you have? Underground
       compassionate use. Food and Drug Administration. Clearinghouse, P.O. Box
       6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.
 DT    9509
 SO    Notes Undergr. 1995 Winter;(no 29):1-3, 8. Unique Identifier : AIDSLINE
       AIDS/95700301
 AB    It comes as no surprise to those in the underground that thalidomide, a
       TNF-inhibitor, is still defined by its teratogenicity, or ability to
       cause birth defects. In the late 1950s, thousands of babies were born
       with horrific birth defects after a company started marketing the drug
       as safe for morning sickness. Forty years later, after three double
       blind placebo-controlled studies, numerous case studies, and hundreds of
       anecdotal reports from doctors treating oral and throat ulcers, the drug
       is still in clinical trials, and not yet available to treat
       AIDS-relatetd wasting. Pilot studies of the drug show significant weight
       gain for patients. In addition, the drug is inexpensive and offers a
       specific mechanism of inhibiting an inflammatory chemical called
       TNF-alpha, the substance which presumably aggravates weight loss in
       people with AIDS. The Underground Thalidomide Compassionate Use Program
       will begin providing thalidomide as soon as they can secure a safe
       pharmaceutical supply.
 DE    Acquired Immunodeficiency Syndrome/COMPLICATIONS  Cachexia/*DRUG THERAPY
       Clinical Trials  Human  Teratogens  Thalidomide/ADVERSE
       EFFECTS/*THERAPEUTIC USE  United States  United States Food and Drug
       Administration  NEWSLETTER ARTICLE

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).