Subject: Letters to the Editor:  Medical Ethics Govern Clinical Drug Trials
Date: Published: 8/1/88 54 lines
Source:  WALL STREET JOURNAL. Copyright Dow Jones & Co. Inc. 

   Letters to the Editor:  
   Medical Ethics Govern
   Clinical Drug Trials

   Your July 14 editorial "AIDS and 1962" is commendable in
the Journal's continuing series of critical articles pointing
out the seemingly glacial pace of drug testing and seemingly
counterpoint regulations mandated by the FDA Act.  You note
the miasma of vested interests, both private and federal,
that may serve to impede meaningful progress toward
expeditious development of beneficial therapeutic agents
through the established mechanism of clinical trials.
   The article distills the clinical-trial debate down to:  
"How do clinicians get their control groups to take blinded
placebos?" and goes on to imply that the nearly inevitable
death of the placebo-treated AIDS patient somehow validates
the evaluation of the experimental drug being tested.  In
 reality, the only way a drug vs. placebo clinical trial can
 be justified is if the efficacy of the drug is sufficiently
equivocal that its benefit is thought to be about as good as
or perhaps slightly better than no treatment at all.  Any
other drug vs.  placebo scenario is clearly unethical.
   As a member of several Data Monitoring and Safety
Committees for National Institutes of Health-sponsored
clinical trials and occasional consultant viewer of new
clinical-trial proposals to NIH, it is apparent to me that
 attention to ethics is not a lip-service function but rather
is the acid test in determining the scientific merit of a
study.  Currently, the ethical problem you pose of mortality
in placebo groups is largely circumvented by masked trials
designed to evaluate the comparative efficacy of two drugs or
therapies concurrently so that all patients receive a course
of treatment believed to hold promise.  In the case of AIDS,
properly designed trials can achieve significant results in a
relatively short period of time with reasonably small patient
populations and maintain strike-force flexibility to address
new therapeutic agents as they are developed.  Witness Food
and Drug Administration Commissioner Frank Young's letter to
the editor of the same date.
    The key issue is not the placebo problem but may be the
larger issue of societal tolerance, which nurtures vested
interests-sometimes at the expense of the common interest.
   Edward B. McLean, M. D. 
   Seattle

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