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AIDS Treatment News
Drugs for Infants and Children: Call for Reform
John S. James
November 4, 1994
AIDS TREATMENT NEWS Issue #210, November 4, 1994

Infants and children with life-threatening diseases face a shocking lack of drugs tested for safety in children -- and tested for the stability of the improvised formulations doctors are often forced to use. At the same time, unnecessary efficacy testing in children -- for example, testing in children of biologically inappropriate ages -- delays treatment availability, and creates obstacles to the testing which is necessary. Arthur J. Ammann, M.D., Research Director of the Pediatric AIDS Foundation, and a member of the National Task Force on AIDS Drug Development, analyzed these problems in a presentation to the Task Force on October 28. He made 14 recommendations for improvement, directed toward the approval of drugs for life-threatening conditions simultaneously for both children and adults.

We cannot summarize the 10-page testimony of Dr. Ammann -- an expert in drug development who was formerly a leading researcher at Genentech, Inc. The bottom line is that this problem is far more serious than generally realized -- and far more correctable. The kinds of re-thinking proposed would improve drug development generally, for adults as well as for children.

For more information, contact Dr. Ammann at the Pediatric AIDS Foundation, 81 Digital Drive, Novato, CA 94949, 415/883- 1796.