Some of the
country's major AIDS treatment activist groups signed on to a statement
admonishing the developer of a potential AIDS vaccine for claiming that
a recent clinical trial shows it might protect Asians and blacks.
The groups slammed
VaxGen Inc. of Brisbane, Calif., saying the data does not back up the company's
claims and could raise false hopes.
"AIDSVAX fails
to protect; VaxGen's claims of efficacy in black and Asian participants
are misleading and premature," the groups said in the statement. "We call
on VaxGen to submit the findings to a panel of outside experts assembled
by the National Institutes of Health for a full examination of the data
..."
The company
said Monday that initial results of an important clinical trial of the
AIDSVAX vaccine showed it did not prevent HIV infection better than a placebo.
But it claimed
"statistically significant" data showing that the vaccine might protect
ethnic minorities, particularly blacks.
HIV infection
in the United States is growing most rapidly among minorities, and AIDS
has become a leading killer of black males, according to the National Institute
of Allergy and Infectious Diseases in Bethesda, Md.
The crisis caused
by high rates of HIV infection and AIDS in Africa is undermining the future
of entire countries.
AIDS groups
say the data doesn't support VaxGen's claim because the number of minority
patients in the trial was very small, making it impossible to draw any
conclusions.
VaxGen pins
its assertions on nine infections among 111 blacks receiving a placebo
and four infections out of 203 blacks who received the vaccine, according
to the advocacy groups. The statement from the groups says the company's
interpretation of the data could spur false hopes and stir racial divisions.
"The smaller
the sample size, the less certain the results ... While the desperate need
for an HIV vaccine is clear, especially among the underserved communities
that bear the brunt of the pandemic, hope cannot take flight on the gossamer
wings of dubious subgroup analyses," the activist organizations said in
their statement.
Major AIDS treatment
activist groups including the AIDS Vaccine Advocacy Coalition, Project
Inform and the Treatment Action Group have already signed the statement.
Representatives of the groups predict many more signatures from other groups.
"We are going
to ask (VaxGen) to stop leaving the impression that this thing is effective
in the African American community," said Martin Delaney with Project Inform
in San Francisco.
VaxGen Chief
Executive Officer Lance Gordon described the data on blacks as a "marvelous
result" on the CNN Financial Network. He said the company would still push
for approval of the vaccine by the Food and Drug Administration, possibly
for use with high-risk groups or populations where the vaccine might be
effective.
VaxGen did not
return calls seeking comment.
--
Copyright 2003 by United
Press International.
All rights reserved.
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