As VaxGen Inc. prepares to unveil further analysis
of its AIDS vaccine study at a scientific conference today, its
reports of potential benefits to minority groups last month continue
to draw both interest and scrutiny.
A coalition of AIDS activist groups is calling for an independent
review by the National Institutes of Health to assess the Brisbane
company's claim that AIDSVAX holds the potential to protect blacks
and other minority groups from HIV infection, though it failed for
the mostly white study participants.
And a growing number of shareholder lawsuits accuse company
executives of puffing up weak data on the possible benefits to some
trial participants. The suits allege VaxGen was trying to cushion
the inevitable price drop of its shares when the largely
disappointing trial results hit the market Feb. 24. The company
denies those claims.
"You announce what you are confident in, what you feel has been
vetted properly, and you let the data speak for itself," said
company spokesman Lance Ignon.
VaxGen's announcement of the results of the first completed
late-stage AIDS vaccine trial ignited cross-volleys of controversy,
however -- not only about its scientific validity, but about its
social impact. Some AIDS groups called the company irresponsible for
spotlighting preliminary data suggesting a protective effect for
people of African or Asian descent when the number of such study
participants was very small.
But minorities and others blasted statements that called the
vaccine trial an overall failure. Critics said the interests of
other racial groups were being ignored because AIDSVAX didn't work
for white participants.
A month later, in spite of continuing skepticism over VaxGen's
claims, a coalition of seven AIDS activist groups is presenting a
united front. It supports a comprehensive NIH review to decide
whether further studies on AIDSVAX should proceed.
"To let it drop would be a huge, huge error, in my opinion," said
Phill Wilson of the Black AIDS Institute, a member of the coalition.
"But by that I don't necessarily mean a need for a new Phase III
trial of 5,000 black people."
The coalition said VaxGen should release its proprietary AIDSVAX
data to an outside NIH panel to clear up statistical criticisms of
the company's conclusion that the vaccine may benefit certain racial
groups.
"If such effects are real, they need to be followed up on with
further research," coalition members said in a letter to Dr. Anthony
Fauci, director of the NIH's National Institute of Allergy and
Infectious Diseases.
"If they are the result of an artifact, the public needs to be
informed of this expeditiously so researchers and the affected
communities can move on to explore more promising vaccine
approaches."
Fauci said he wants a "very, very thorough, unbiased good look"
at the VaxGen data, and plans to convene a panel that honors
activists' requests for significant minority representation. If the
panel finds some promise of benefit, NIAID will move to the question
of funding another trial.
"We will seriously consider it," Fauci said.
Ignon, VaxGen's spokesman, said the company's presentation at the
Keystone Symposia in Canada will be one of many opportunities for
the scientific community to review the AIDSVAX data and company
analyses that are continuing.
Declining to outline the scope of today's session, he said the
company would cooperate with an NIH review.
E-mail Bernadette Tansey at
btansey@sfchronicle.com.