Path: bloom-picayune.mit.edu!enterpoop.mit.edu!snorkelwacker.mit.edu!americast.com!americast.com!americast-post
Newsgroups: americast.wpost
From: americast-post@AmeriCast.Com
Organization: American Cybercasting
Approved: americast-post@AmeriCast.com
Subject: AIDS Experts Back Trial Of Controversial Vaccine<By Sally Squires<Washington
Date: Tue, 24 Nov 92 04:42:49 EST
Message-ID: <33.1992Nov24.044249@AmeriCast.com>
Lines: 94

AIDS Experts Back Trial Of Controversial Vaccine<By Sally
Squires<Washington Post Staff Writer=

A federal panel voted unanimously yesterday to recommend a clini-
cal trial of a controversial AIDS vaccine despite what the group
said was lack of traditional scientific justification for the
program.

In view of the urgent nature of the AIDS problem, "The panel dis-
cussed in great detail other, nontraditional scientific cri-
teria," said Anthony S. Fauci, director of the Office of AIDS
Research at the National Institutes of Health (NIH) and chairman
of the panel that made the recommendation.

Based on that review, Fauci said, the panel decided that there
were enough data to recommend a large-scale clinical trial of the
vaccine, known as gp160, but added two conditions.

"They said it should be done in combination with other related
products, and that the trial should be done not just in the mili-
tary or in the (Veterans Administration), but in a good represen-
tation of the HIV community in the country."

NIH has traditionally been the arbiter of nearly all AIDS trials
and the drugs used in them. But in a highly unusual move in Oc-
tober, Congress bypassed NIH and ordered a $20 million Defense
Department trial of the gp160 vaccine, a substance made from part
of the outer coating of the AIDS virus.

The move surprised AIDS researchers and activists. Many in the
research community viewed it as an unprecedented invasion of pol-
itics into the realm of science. "NIH was taken out of its usual
role of deciding which therapies and studies, from a scientific
and ethical standpoint should receive federal support," NIH
director Bernadine P. Healy told the panel at its first meeting
on Nov. 5. She likened the process to the "tail wagging the dog."
Congress's action followed lobbying by former senator Russell
Long (D-La.) on behalf of one gp160 vaccine manufacturer, Micro-
GeneSys. The legislation, part of the defense appropriations
bill, stipulated that unless NIH, the Defense Department and the
Food and Drug Administration determined within six months that
the trial should not go forward, the money should be spent on a
large-scale test effort.

The panel's recommendation will now go to an advisory committee
that reports to Healy and is expected to approve yesterday's de-
cision on Dec. 2. Healy will then have to decide whether or not
to recommend the clinical trial.

Gp160 is a genetically engineered protein that coats the AIDS
virus. Since 1989, Robert Redfield and colleagues at the Walter
Reed Army Medical Center have been testing the gp160 vaccine in
HIV-infected volunteers. Known as a therapeutic vaccine, gp160 is
not intended to prevent AIDS. But researchers hope that it might
be able to boost the immune system into fighting the virus. The
hope is that it may keep infected people healthy for a longer
period before they develop full-blown AIDS.

But the scientific results are mixed.

Although there is apparently no question that the vaccine is
safe, doubts remain about its efficacy. The vaccine is intended
to reduce the virus's ability to destroy CD4 cells, an integral
part of the body's immune-system defense. Redfield and his col-
leagues as well as other researchers have found that the vaccine
can cause alterations in the immune response of those infected
with the virus,  a shift regarded as a "surrogate marker" of the
vaccine's ability to fight HIV.

But scientists debate whether or not such surrogate markers are
reliable enough to prove that the vaccine can keep people
healthy. To date, no study has found that the vaccine can do so.

What is still to be determined is how big the trial should be and
whether or not drug companies besides the Connecticut-based Mi-
croGeneSys should be asked to help fund the trial to expand its
scope.  Spokesmen from Genentech and Biocine said that they had
ample vaccine and were willing to participate, although they said
that they could not commit yesterday to paying for additions to
the trial.

FDA Commissioner David A.  Kessler said that the meeting was more
than just about whether or not to go ahead with a clinical trial
of gp160. "This is not about any one particular vaccine," Kessler
said. "Today's meeting really went to the national strategy of
deciding what's our policy going to be for therapeutic vaccine
for AIDS."<02:27 11-24C9999-----

Copyright 1992, The Washington Post.  This story is from the
Washington Post's Capitol Edition On-Line and is not to be ar-
chived or redistributed.

For more information, send-email to American Cybercasting Cor-
poration (usa@AmeriCast.COM)