Subject: REVIEW & OUTLOOK (Editorial):  AIDS and 1962
Date: Published: 7/14/88 92 lines
Source:  WALL STREET JOURNAL. Copyright Dow Jones & Co. Inc. 

   REVIEW & OUTLOOK (Editorial):  
   AIDS and 1962

   As the President's AIDS Commission prepared for its final
meeting recently, we wrote that it should recommend
suspending the 1962 Kefauver amendments to the FDA Act.
Kefauver mandates clinical trials to prove a drug is
effective before it's made publicly available.  This rule is
separate from the noncontroversial drug-safety requirement,
which was mandated in 1938.  We said this single step would
help AIDS patients more than any other measure currently
being discussed.
   So when the Commission released its final report we were
gratified to find the following recommendation on page 53:  
"The Food and Drug Administration should fund an independent
scientific organization to conduct an independent review of
safety (sic) regulations dictated by the 1962 Kefauver
amendments to determine whether they should be relaxed for
drugs used under Treatment IND regulations that are intended
for terminally ill patients who have given informed consent."
   This is a beginning.  It is a first step toward correcting
the deficiencies of the current regulatory framework.  An
attorney for the Lambda Legal Defense and Education Fund
recently called that framework "virtually useless in helping
people with AIDS.  " People with AIDS, however, should
understand that the forces arrayed to kill any proposal to
suspend Kefauver are formidable.  In the letters column
nearby, FDA Commissioner Frank Young makes the argument
against this idea.  He believes that double-blind,
placebo-controlled trials are the "fastest" way to develop
effective AIDS therapies.
   A wide-open debate over Kefauver would be useful, because
it would lay on the table the primary -- and in our opinion,
often competing-interests at play in the battle against AIDS. 
People with AIDS primarily want the alleviation of their
agony; scientific researchers primarily want statistical
confirmation of their strenuous intellection; the FDA wants
to avoid AIDS precedents that diminish its control of other
U. S. drug research; and the drug companies want to bring a
product to market with a federal seal of approval on the box.
   AIDS-relief advocates are acutely familiar with the delays
these issues have caused.  They've heard promises so many
times about "speeding up the system" that they have reason to
regard anyone's proposals with skepticism.  So let us make the
central focus of our own idea clear.
   We are not against a statutory requirement to ensure
 safety, with the caveat that the question of safety must be
related to the severity of the disease.  Nor are we against
the basic idea of clinical trials of effectiveness, though we
believe these can continue after the drug's release to the
public.  The key issue is:  How do the clinicians get their
control groups to take blinded placebos?  Usually in a blinded
placebo-controlled experiment, one group gets the
experimental drug, and the other basically gets nothing.  The
resulting deaths in the group that got nothing "controls" the
evaluation of the genuine.  In the midst of a medical crisis
such as this, where does it say in the Hippocratic oath that
patients have to accept a 1962 FDA efficacy rule (based on a
sedative given to pregnant women) that forces half of them in
these trials to accept a placebo?  
   One of the things people with AIDS would discover if they
looked into the Kefauver issue is that in fact there was a
functioning process of drug discovery before Kefauver.  In
"New Drug Development:  A Regulatory Overview" (Omec
International, Washington, D. C.)  one finds the following:  
"The 1950s marked a golden era for pharmaceutical
manufacturers...  .  According to one authority, the apex of
new drug innovation was reached in 1949, when 559 new
products were reported.  By contrast the comparable figure in
1969 (seven years after Kefauver) was only 83...  .  The
costs of regulatory compliance were relatively minor and the
average regulatory review time was seven months."
   In his letter this morning, Commissioner Young says that
suspending Kefauver "would not be supported by American
science or most AIDS patients."  We know where "American
science" stands.  But let's find out if Frank Young is right
about the AIDS patients.  We propose that a referendum,
limited to people who have tested HIV-positive, be conducted
to determine whether they would support or oppose lifting the
Kefauver requirements for the AIDS crisis.  Let them read this
editorial, Frank Young's letter and whatever else -- and then
vote.

[This article is made available here by Dow Jones Co. for the 
personal and non-commercial use of callers to this bbs, in the 
hope that it will be of some help to those who are suffering 
from the disease and others who are seeking to help them.]