Subject: REVIEW & OUTLOOK (Editorial):  Medicine Fights Back
Date: Published: 5/9/88 103 lines
Source:  WALL STREET JOURNAL. Copyright Dow Jones & Co. Inc. 

   REVIEW & OUTLOOK (Editorial):  
   Medicine Fights Back

   The controversy over Accutane, the acne drug, has had the
look and sound of a familiar script, with the same cast of
characters that has appeared in many past dramas over an
accused drug.  Federal drug officials blow the whistle on the
drug's dangers, an outraged voice is heard from Capitol Hill,
consumer advocates threaten lawsuits, and headlines appear in
the press.  The word "thalidomide" is uttered.
   The script calls for doctors and drug companies to run for
cover, and the drug and anything like it are banished from
American's pharmacies, to the cheers of a grateful citizenry.
But this time, the script fell apart.  Medicine fought back.
   Everyone understood when Accutane was approved in 1982
 that it could cause birth defects if taken by pregnant women,
and warnings have been issued and re-issued.  In six years,
birth defects associated with the drug have been reported in
62 cases, in a generally declining trend from 24 in 1984 to
eight in 1986 and one in the first seven months of 1987.  But
two weeks ago Accutane headlines suddenly erupted, based on
an FDA office's statistical extrapolation from a Michigan
Medicaid population.  Three FDA officials charged that most
birth defects weren't reported, that most patients didn't
need the drug, and that up to 1,300 babies may have been born
malformed to mothers who used Accutane while pregnant.
    "We believe the data presented in this document warrant
active consideration of removal from the market," the FDA
officials concluded.  "I see no reason why this course should
not be followed," Rep. Ted Weiss commented predictably.
Consumer advocate Sidney Wolfe recited a familiar line from
memory:  "American families are too important to be left to a
Reagan administration that seems to give deference to the
drug industry."
   But Hoffmann-La Roche, the drug's manufacturer, denounced
 the agency's extrapolation study as "invalid" and
"essentially meaningless."  And doctors rushed to defend the
competence of their profession.  "To suggest that 97% of
patients don't deserve treatment with Accutane is at least
silly," said Dr. James Leyden of the University of
Pennsylvania medical school.  "It's outrageous to say that."
    Nobody talks to the FDA like that.  At least they never
used to.
   This time the patients got a hearing.  Accutane is widely
regarded as a "miracle drug," the only available therapy for
cystic acne.  Its effect on this virulent, disfiguring ailment
is depicted in the accompanying photographs (see accompanying
illustration -- WSJ May 9, 1988).  Moreover, it virtually
eliminates the condition permanently.
   Accutane defeats difficult acne because it shuts down
certain rapidly dividing cells.  It can distort a fetus in the
same way.  Theoretically, compounds like this could also
combat cancers; indeed, Roche is testing a closely related
substance on some intractable cancers.
   Some in the FDA, the Congress and the scare industry would
react to these realities by banning the drug, because even
with strict warnings human error will always occur.  Since
thalidomide, this bureaucratic absolutism is the level at
which much discussion of drugs, and much FDA action, has
dealt with such issues.  The real task obviously is to
accommodate the needs of both potential beneficiaries and
victims.  By fighting back this time, the doctors and
Hoffmann-La Roche have pushed the controversy back toward the
center of serious disagreement, where it is more likely to
receive a balanced resolution.
   For example, in response to Roche's startlingly harsh,
uncompromising critique, an FDA spokesperson said the staff
study didn't "represent the agency's position...  .  It
hasn't been peer-reviewed or presented to a group of
scientists."  A doctor on the FDA advisory committee charged
with reviewing the evidence told a reporter:  "If the drug is
used correctly it is a highly effective drug.  If it is used
incorrectly it is highly dangerous.  You are allowing a few
people to ruin it for the people who are using it correctly.
 That's not fair."
After a day of often heated discussion before the advisory
committee, the panel offered FDA Commissioner Frank Young a
range of options for resolving the controversy.  His decision
is expected in about a month.  It is of course possible that
Dr. Young will impose draconian restrictions on Accutane.  But
the force of the medical community's reaction to the crude
attack on a helpful therapy, and on the practice of medicine
in the U. S., marks progress.  It may be that after watching
victims of AIDS and Alzheimer's argue that the needs of
patients should prevail over the needs of statistical
proceduralism, doctors and the pharmaceutical industry have
finally decided that their rights also deserve a fair
hearing.
   The goal of this forward movement is a more sensible,
humane system that recognizes both risks and benefits, not
only the dangers inherent in progress and indeed life, but
 also the needs of patients and their families who are
standing at the edge of medical science asking for help.

[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.]