Subject: FDA Studies Data Submitted on New AIDS Drug by Imreg
Date: Published: 7/28/88 83 lines
Source:  WALL STREET JOURNAL. Copyright Dow Jones & Co. Inc. 

    FDA Study of Imreg Is Apparently Tied
    To Data Submitted on New AIDS Drug
    ----  
    By Marilyn Chase
    Staff Reporter of The Wall Street Journal

   Imreg Inc., already the target of a congressional inquiry,
is said to be under investigation by the Food and Drug
Administration for possible "irregularities in data"
submitted on its AIDS drug Imreg-1.
   Word of the new investigation surfaced in FDA Reports, a
drug-trade newsletter popularly known as "the pink sheets."
The newsletter said this week that "FDA inspection of the
firm's New Orleans facilities reportedly began the week of
July 18, and is ongoing."  In Bethesda, Md., an FDA official
declined to comment on the report, referring a reporter to
the company.
   Arthur Gottlieb, who with his wife Marise Gottlieb head
the New Orleans biological concern, confirmed the inspection
of Imreg facilities took place, but said it was "a routine
investigation" accelerated because of the priority given
drugs against acquired immune deficiency syndrome.
   He denied any implication that the visit was spurred by
suspected flaws in its data.  "I'm astounded," Dr. Gottlieb
said.  "The trial was sound.  We know of no irregularities.  I
think this is a clean result, and an important report, and
it's being muddied by these allegations."
   The Gottliebs say the drug achieved a five-fold reduction
in the risk of progressing from AIDS related complex, or ARC,
to AIDS. 
   The House Subcommittee on Investigations and Oversight is
poring over FDA files on Imreg, in an inquiry believed to
focus in part on the question of whether the company breached
FDA rules by pre-approval promotion of its drug.
Questions about the design of the Imreg-1 study, and
whether the data actually support such a dazzling therapeutic
claim, surfaced among scientists at the Fourth International
Conference on AIDS in Stockholm last month.  The company
repeatedly has defended its work.
   But one of the independent researchers participating in
the Imreg-1 study takes issue with its conclusions.  Sheldon
Landesmann, a physician researcher at the State University of
New York Health Sciences Center in Brooklyn, N. Y., removed
his name from the Imreg study in a dispute with the company.
Dr. Landesmann declined public comment citing a
confidentiality agreement with Imreg.
    Dr. Gottlieb said the researcher's defection resulted
because Dr. Landesmann "was asking to see a complete data set
outside our confines so that he could study it for an
extended period of time for his own purposes.  We didn't need
Landesmann to act as a second FDA.  "
   Outside scientists who weren't participants but who looked
at the company's presentation say it raises several
questions.  Among them:  were volunteers properly grouped at
the study's outset, according to how weak or strong their
immune systems were, as measured by levels of T4 cells, key
immune sentries decimated by the AIDS virus.
   California researcher Paul Volberding said he needed to
know how Imreg grouped the sickest patients -- those with
below 200 T-4 cells -- into groups receiving the drug or a
placebo, or dummy drug.  In addition, a number of patients
were withdrawn from the study and given drugs other than
Imreg.  The fate of such patients could potentially affect the
study's conclusions.
   Adding fuel to the fire over Imreg is the intense interest
taken by bullish brokers with major holdings, and by
short-sellers who devour news of its current troubles.  In
national over-the-counter trading yesterday, Imreg Class A
common stock closed at $11.875 a share, down 87.5 cents.
   One AIDS researcher says he maintains an open mind about
the virtues of Imreg-1, but questions the study's technical
correctness.  "This drug could work," he said.  "I just think
it deserves a better trial."

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