Subject: REVIEW & OUTLOOK (Editorial):  An AIDS Crisis Proposal
Date: Published: 6/15/88 99 lines
Source:  WALL STREET JOURNAL. Copyright Dow Jones & Co. Inc. 

   REVIEW & OUTLOOK (Editorial):  
   An AIDS Crisis Proposal

   With a preliminary report including nearly 600
scatter-shot recommendations, the President's AIDS commission
looks terminally ill.  This commission exists only because
AIDS victims shouted that the system's response to their
crisis has been inadequate, but the commission's answer has
been anti-bias laws and proposals to build more FDA
buildings, leaving the system not only intact but expanded.
   AIDS is not a civil-rights problem; it is a fatal virus.
One that destroys the human immune system, leaving a person
defenseless and after much suffering, dead.  The commission
meets again tomorrow and Friday in Washington to consider
amendments to its preliminary report, so there is still a
chance for its members to demonstrate that they understand
they're talking about a medical crisis.  The Gordian knot is
before them, in the Kefauver Amendments to the Food and Drug
Act.
   Ever since Congress passed Kefauver in 1962, a drug's
sponsor has had to prove not only that a drug is safe, which
has been required since 1938, but that it's also efficacious
 -- that it works.  It is the efficacy requirement that
requires double-blind, placebo-controlled, multi-center
trials with statistically significant outcomes.  This standard
 -- created in response to an unsafe sleeping pill called
thalidomide -- makes utterly no sense for an incurable,
terminal disease.
   The commission's own report is eloquent on the point:  
 -- "Witness criticism of the drug approval process dealt
mainly with the length of time involved from start to
finish."
 -- "In spite of the best efforts of the Commissioner of
the FDA, with respect to newly developed anti-viral drugs or
immunomodulators, the treatment IND program is a failure for
persons with AIDS. 
 -- "Methods of obtaining drugs that are available through
this program are poorly understood and seem unnecessarily
complicated."
 -- "Some representatives expressed concern that if they
did apply for a treatment IND, their subsequent NDA {this is
in the Kefauver-mandated phase of approval} would not be
favorably approved."
 -- "We have received many calls and letters from concerned
patients, their friends and families seeking help.  They were
unable to find answers to the simplest questions about the
availability of drugs.  There was no centralized information
network, and no one to help them through the FDA maze."
 -- "Individuals who qualify for this program are by
definition desperately or terminally ill, and it is
unacceptable that this situation has languished this long
without resolution."
   As AIDS patients confront the situation just described, we
somehow doubt that the first thing on their minds is civil
rights.  The commission needs to do something for their human
rights.  In recognition of a national medical emergency, it
should recommend suspending the drug-approval requirements of
the Kefauver Amendments for AIDS drugs.
   Anyone familiar with the U. S. drug-approval process will
see immediately that this one step would radically expand and
speed access to promising AIDS therapies.  The government
would retain its statutory authority to monitor and regulate
the safety of new AIDS compounds prior to approval for public
sale.  Once a substance is deemed acceptably safe, however,
the FDA would release the AIDS drug to the public, as it did
with all drugs from 1938 until 1962.  Determinations about the
drug's efficacy would be left to three groups -- the research
community, attending physicians and patients.
   Parts of the FDA bureaucracy would oppose such a proposal.
Some members of the research establishment would scream that
standards of efficacy would be compromised.  But if the AIDS
community is forced to accept the research establishment's
current bench marks of "efficacy" -- dramatic, AZT-type
improvements or killing of the virus -- victims will be
waiting and dying into the next century.  What "works" in our
view is any nonlethal drug that alleviates suffering or pain,
that gives an AIDS patient the consolation that he or she
fought back with something of promise, rather than going
passively to certain death.
   Suspending Kefauver for these people would be a
compassionate, appropriate and indeed moral response to the
AIDS crisis.  With their nearly 600 recommendations, the
commissioners are in great danger of failing to see the
forest for the trees.  So far, they seem intent to expand the
status quo.  They must shrink a regulatory status quo that
they themselves have just judged to be unacceptable.  As a
first, significant step to that goal the commission should
release the AIDS crisis from the unnecessary and destructive
burden of the Kefauver Amendments.

[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.]