Drugs for Infants and Children: Call for Reform

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.