Subject: Congress Investigates Imreg's Handling Of Imreg-1 Drug
Date: Published: 7/22/88 98 lines
Source:  WALL STREET JOURNAL. Copyright Dow Jones & Co. Inc. 

   Congress Investigates Imreg's Handling
   Of Its Experimental Drug Against AIDS
    ----  
   By Marilyn Chase
   Staff Reporter of The Wall Street Journal

   The U. S. House of Representatives has launched an
investigation into the conduct of Imreg Inc. in connection
with its experimental drug Imreg-1 for acquired immune
deficiency syndrome.
   The House Subcomittee on Oversight and Investigations of
the Committee on Energy and Commerce, led by Rep. John
Dingell (D. Mich.)  , is conducting the probe of the New
Orleans-based biomedical company.  One question at the heart
of the probe is understood to be whether the company
improperly promoted the unapproved therapy.  Imreg is seeking
Food and Drug Administration approval for the drug, which it
says can block progression from AIDS-related complex to AIDS
in infected patients.
   "Rep. Dingell has sent a letter to the FDA requesting
copies of documents in possession of the FDA relating to any
pending regulatory activities relating to Imreg," a
subcommittee staff member said, refusing to comment further.
   An FDA official confirmed that a probe was under way,
adding that the subcommittee was examining correspondence in
the FDA's files relating to public statements made by the
company.  The subcommittee's jurisdiction doesn't focus on
science per se, but includes the conduct of publicly traded
companies.
   An Imreg spokesman said, "We have not been contacted by
the committee."  He said that Imreg learned of the probe
through news reports and that it stands by clinical trial
data on the drug.
   The probe is considered unusually sensitive because of
interest in Imreg-1 among AIDS patients, a controversy raging
between skeptics and believers in the drug and the volatility
of the company's stock.
   In national over-the-counter trading yesterday, on the
news of the probe, the company's Class A shares plunged $2.50
to close at $12.875 in heavy trading.
   FDC Reports, a drug trade newsletter, said this week that
the probe would focus on the question of the company's
promotional statements last spring that publicized
encouraging results of Imreg's clinical test -- long before
the release of data last month at the International
Conference on AIDS in Stockholm.  Subcommittee and FDA
officials declined to address such a view, calling it
speculative.  However, pre-approval promotions of an
experimental drug are forbidden by FDA. 
   In Stockholm, Imreg presented results of a 158-patient
study that Imreg said proved that the risk of developing AIDS
was five times greater in an untreated patient than in a
patient taking Imreg-1.  The results were presented by A. 
Arthur Gottlieb, Imreg chief executive officer, and his
physician-wife Marise Gottlieb.
   Dr. Gottlieb said in an interview then that he believes
that Imreg-1 enhances the ability of T-cells, white blood
cells of the immune system, to produce "a cascade" of
interleukin-2, interferon and other immune-boosting proteins.
He said the data was being submitted to a peer review
scientific journal.  The stock climbed steeply in June on news
of the study, and on widespread rumors that a big drug
company might buy the company.
   However, to some scientists at Stockholm, the study raised
questions about Imreg-1.  "This is interesting, but we'd want
to know more and so would the FDA," said Daniel F. Hoth,
director of the AIDS program at National Institute of Allergy
and Infectious Diseases.  Dr. Hoth said he specifically needed
proof that the patients in both the drug and placebo groups
"were equally sick" before the trial began to rule out biased
conclusions.  Dr. Hoth recently was named a consultant to the
FDA in its review of the Imreg data.
   Compounding the controversy were reports at Stockholm that
an independent researcher studying Imreg had removed his name
from the study.  The researcher, who requested anonymity,
declined to comment on the trial.
   Another researcher in the Imreg study, David Henry of
Graduate Hospital in Philadelphia, countered that he thought
the Imreg trial was "well done and results need to get out,"
even while acknowledging it is "controversial."
   Dr. Henry said he expects journals to demand more
information on the numbers of T-4 cells in patients.  T-4
levels are a common index of immune health or weakness, and
their equal distribution among patients is critical to
ensuring the objectivity of all such studies.  When she was
questioned at Stockholm about T-4 distribution in the study,
Dr. Gottlieb said the drug and placebo groups were adequately
analyzed and controlled.

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