Xref: pa.dec.com sci.med:28368 sci.psychology:5734 alt.religion.scientology:295
Newsgroups: sci.med,sci.psychology,alt.religion.scientology
From: sdb%hotmomma@uunet.uu.net (Scott Ballantyne)
Subject: FDA Dismisses Scientology's Claims about Prozac
Message-ID: <1991Aug5.041337.4740@hotmomma.UUCP>
Sender: sdb%hotmomma@uunet.uu.net (Scott Ballantyne)
Organization: ScotSoft Research
Date: Mon, 5 Aug 1991 04:13:37 GMT

The following press release from the FDA should be of interest to
those who have been following the Prozac/Scientology battles.

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   On July 26, 1991, FDA informed the Citizens Commission on Human
Rights (CCHR), a group affiliated with the Church of Scientology, that
the agency was denying its request to withdraw marketing approval for
the antidepressant drug Prozac (fluoxetine hydrochloride).  The agency
decided that withdrawal proceedings were not warranted.

   CCHR submitted its petition to FDA in October 1990, and
supplemented it with further submissions in November 1990 and June
1991.  The petition, along with other letters from the group, asked
the FDA to withdraw Prozac from the market because of its purported
links to suicide, violent behavior and movement disorders, as well as
its alleged addictive nature.

   FDA reached these conclusions after carefully reviewing each of
these charges and the evidence provided by the group.  In addition,
FDA examined data supplied by the drug's manufacturer, Eli Lilly and
Company of Indianapolis, including data from controlled clinical
studies on the drug.  Adverse reaction reports involving Prozac were
also carefully scrutinized, as well as relevant published material on
the drug.

   FDA's review revealed no basis for concluding that Prozac caused
these adverse clinical events.  For example, CCHR based many of its
claims that Prozac caused increased suicidality in depressed patients
on increased frequency of adverse reaction reports of suicide and
attempted suicide among depressed patients on Prozac.  These data,
however, provide no way of distinguishing the role of the patients'
underlying medical condition and the role of the drug in causing these
suicidal events.  Depression itself is highly associated with suicide.
An analysis of controlled clinical trials that allowed a direct
comparison of the incidence of emergent suicidal thoughts and actions
among individuals on Prozac, placebo or other antidepressants failed
to find any greater risk among those on Prozac.

   In general, FDA rejected CCHR's contention that the number of
adverse reaction reports that have involved Prozac constituted
evidence that the drug should be removed from the market.  CCHR, in
its petition and in other material, has stated that the agency
received more adverse reaction reports about Prozac than any other
drug in 1990.  However, this fact must be evaluated in the proper
context.

   CCHR's argument ignores the wide variation in types of adverse
reactions reported for Prozac.  Many of these reports involve
relatively minor problems.  Moreover, the volume of adverse reactions
associated with Prozac is not unexpected for a product that is widely
used and that has been the focus of intense public interest.

   FDA, in its denial letter to CHHR, did inform the group that the
agency will continue to assess new information.  To this end, the
agency will convene a meeting of its Psychopharmacological Drugs
Advisory Committee to consider the issue of suicidality associated
with antidepressant drugs, including Prozac.  All pertinent data on
the possible relationship between these drugs and suicidality will be
thoroughly reviewed at this meeting in order to resolve any concerns
on this issue.
   CONTACT:  Food and Drug Administration Press Office, 301-443-3285