Subject: Letters to the Editor:  FDA's Role in AIDS Drug Therapy
Date: Published: 7/14/88 58 lines
Source:  WALL STREET JOURNAL. Copyright Dow Jones & Co. Inc. 

   Letters to the Editor:  
   FDA's Role in AIDS Drug Therapy

   Your June 15 editorial "An AIDS Crisis Proposal" attempts
to convince readers that a good way to speed the access of
promising AIDS therapies is to approve drugs that are safe -- 
even if they don't work.  I think this viewpoint is very
shortsighted, and would not be supported by American science
or most AIDS patients.  In the guise of giving the dying
"hope," your editorial would undercut the science that can
lead to a true and useful therapy.
   Decades of experience with the development of drugs and
vaccines has led us to the well-accepted concept that
systematic, phased clinical trials are the best and indeed
the fastest and surest way of developing effective treatments
for diseases such as AIDS.  I think this point is underscored
by the recent success with Retrovir (formerly AZT).  In
double-blind, placebo-controlled trials lasting only six
months, this drug was shown to prolong the lives of AIDS
patients, and in 107 days, it was approved for commercial
use.
   There is not a single bit of evidence that AZT would have
been available one day sooner if "only" safety data had been
reviewed.  In fact, the opposite was true.  It was the
overwhelming evidence of the efficacy of AZT that outweighed
its severely toxic side-effects and allowed it to be
commercially available in record time.
   In addition, with the Food and Drug Administration's
Treatment IND (investigational new drug) program, drugs can
be made available to AIDS patients even before they're
approved for commercial distribution.  In September 1986 -- 
about six months before commercial approval -- the FDA
granted a Treatment IND for AZT, making it available to more
than 4,000 AIDS patients before its final approval in March
1987.
   In the absence of good scientific evidence that a drug is
safe and effective, it is impossible to know if it "works" or
that it gives the AIDS patient the "consolation that he or
she fought back with something of promise."  The Gordian knot
is not the Kefauver amendments to the Food and Drug Act.  It's
finding AIDS drugs that work! When we find such a drug -- 
such as AZT -- the FDA will see that the drug is available as
fast as is humanly possible.
   Frank E. Young M. D. 
   Commissioner of Food and Drugs
   Food and Drug Administration
   Department of Health and Human Services
   Rockville, Md.

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hope that it will be of some help to those who are suffering 
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