Subject: Imreg Attacks FDA's Refusal To Back Its Drug for AIDS 
Date: Published: 11/22/88 88 lines
Source:  Wall Street Journal.  Copyright Dow Jones & Co. Inc. 

    Technology:  
    Imreg Attacks FDA Committee's Refusal
    To Back Distribution of Its Drug for AIDS
    ----  
    By Dianna Solis
    Staff Reporter of The Wall Street Journal

    Imreg Inc. lashed out at Food and Drug Administration
 staff members for "incomplete and incorrect" analyses of its
 clinical tests of a treatment to combat AIDS. 
    On Friday, the biomedical concern was dealt a serious blow
 when an outside advisory committee to the FDA withheld
 recommendation for limited distribution of Imreg's compound.
 During the committee's meeting, tough questions from FDA
 staff members prompted more than a 50% decline in Imreg's
 stock price as some spectators in the crowd of about 120
 carried mobile phones to relay information quickly to
 traders.
    The outside panel requested more time to examine further
 the FDA's analysis of Imreg's data and to review the
 company's response to the agency.
    Yesterday, Imreg's president and chief executive officer,
 A. Arthur Gottlieb, said that the company would address all
 of the FDA's concerns, but had no plans to redo its clinical
 trials on 158 patients who had either acquired immune
 deficiency syndrome or AIDS-related complex, a precursor to
 AIDS.  "We have valid answers to everything they raised," Dr. 
 Gottlieb said.  "We do not accept their conclusion that the
 drug has not proven its case."
    In general, he accused the FDA staff of treating Imreg
 "very shabbily," saying that the company was "confronted on
 very short notice with a portion of their analysis, and then
 on the day of the meeting, without any prior {knowledge,} we
 had a large amount of additional information to digest."
    But the physician executive declined to address a central
 FDA concern regarding "insufficient safeguards" in the
 placebo control group during clinical trials.  Since a major
 international conference on AIDS in Stockholm last June,
 Imreg has been dogged by criticism in the scientific
 community that the sickest of the sick received a placebo in
 Imreg trials, while the healthiest of those infected with the
 AIDS virus received the Imreg compound.
    In national over-the-counter trading yesterday, Imreg
 stock fell further, closing at $4.125, down 37.5 cents.  The
 stock traded as high as $16.375 in July.
    At the FDA, a spokesman characterized the eight-and-a-half
 hour meeting as "certainly spirited," then he issued a short
 statement that the FDA and Imreg agree that certain questions
 must be resolved before the Imreg compound can be approved as
 an investigational drug.
    As an investigational drug with proven effectiveness, the
 compound would be available to patients even before being
 approved for commercial marketing.  When data are presented
 that are technically unassailable -- as was the case with
 Burroughs-Wellcome Co. 's anti-AIDS drug AZT -- the FDA has
 shown itself willing to grant investigational status in a
 mere five days.  Imreg's study, by contrast, raised more
 questions than it answered.
    "I saw nothing in the record of the data presented on
 Friday which would justify" granting such status, said Daniel
 Hoth, director of the AIDS program for the National Institute
 of Allergy and Infectious Diseases.  Dr. Hoth has been asked
 to consult with the FDA in its Imreg review.
    Imreg, which is based in New Orleans and went public in
 1984, has yet to record a profit or bring a product to
 market.
    ---
    Marilyn Chase contributed to this article.
    (See:  "Corrections & Amplifications:  Imreg Inc.  " -- WSJ
 Nov. 22, 1988 which appears below:  )

    Corrections & Amplifications:  
    Imreg Inc. 

    IMREG INC. criticized staff members of the U. S. Food and
 Drug Administration for their analyses of clinical tests of
 the company's proposed AIDS drug.  A headline in an earlier
 edition incorrectly suggested the company had criticized an
 outside advisory panel to the FDA. 

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