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Ignoring the advice of government scientists, the US Army is to spend
$20 million of federal funds on a large-scale trial of an experimental immune
therapy in HIV-positive people. Members of the panel that advised against
the trial are appealing to the US Secretary of Defense in a final attempt
to block it.

Army scientists want to test a vaccine based on a genetically engineered
form of HIV’s coat protein, gp160, in infected people to see whether it
boosts their immune systems against the virus. The vaccine is made by MicroGeneSys,
a small company in Connecticut. Last autumn, Congress awarded the army
$20 million specifically for a trial of the company’s product. Bernadine
Healy, director of the National Institutes of Health, objected on the grounds
that scientists, not politicians, should decide the details of clinical
trials (This Week, 24 October 1992).

A panel of scientists and representatives of people with HIV was set
up before Christmas to advise the directors of the NIH and the Food and
Drug Administration on the plan. The panel said there was no clear scientific
justification for a large study of the vaccine. Instead, the army should
spend the money on a trial comparing several different experimental vaccines.
The NIH and the FDA accepted the panel’s advice and recommended a broader
trial (This Week, 5 December 1992).

But a spokeswoman for the army confirmed last week that the trial would
go ahead as originally planned. ‘We were instructed to study gp160,’ she
said.

Å®ÉúСÊÓƵs and activists attending a research meeting in Albuquerque
reacted angrily to the decision. Members of the advisory panel wrote an
open letter to the defence secretary, Healy and David Kessler, Commissioner
of the FDA. ‘It is a matter of considerable regret that the Department of
Defense has chosen to utterly ignore the recommendation of the NIH and
the FDA,’ says the letter.

Last month MicroGeneSys withdrew gp160 from the US government’s network
of AIDS clinical trials run by the NIH. ‘The scientific grounds for this
withdrawal are highly dubious,’ say the panel’s members in their letter.
‘It is therefore curious that the company seeks federal funding for a non-comparative
trial of its product, while simultaneously rejecting funding for an objective
trial of its product . . . Individuals with HIV deserve more respect.’

The letter was signed by three leading AIDS researchers from the panel:
Dani Bolognesi from Duke University, Lawrence Corey from the University
of Washington, Seattle, and David Ho from the Aaron Diamond AIDS Research
Center in New York.