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.