How CDC leader
hiding secret VaxGen job deal campaigned
for trials like AidsVax
The
failure of AidsVax to prevent infection
with HIV - in clinical trial results
published in 2003 - triggered an intense
debate about the controversial product
and its manufacturer, VaxGen Inc of
Brisbane, California. Mail to this
website, maintained by Brian Deer, shows that
existing material on a VaxGen-AidsVax
index is read by significant
numbers. This page seeks to further
inform the discussion
An
influential paper by Dr William Heyward
et al, from the US Centers for Disease
Control, published in the Journal
of the International Association of
Physicians in Aids Care in
August 1997, caricatured scientific
debates over Aids vaccines as between
"theorists" and
"empiricists". Lambasting the
"theorists" - including
scientists at the National Institutes of
Health and academic institutions
worldwide - the paper cheers the
"empiricists", who in the face
of basic problems "argue that it is
only through phase III efficacy trials
that such dilemmas may be resolved, or
that these perceived obstacles may in
fact turn out to be irrelevant".
The
article was one of a series which
contributed to Heyward's subsequent
disgrace, after it was discovered later
that he had concealed a deal to join
VaxGen Inc, the only company to be
preparing such a trial. In October 1998,
a VaxGen-sponsored supplement to the
journal Aids Research and Human
Retroviruses continued to hammer
his message, this time roping-in an
official of the Food and Drug
Administration. Here, Heyward spoke of
the "so-called 'theorists', who feel
that more knowledge is necessary before
we can intelligently proceed with vaccine
development, and the 'empiricists', who
take a more pragmatic, but cautious,
trial-and-error approach and feel that
some of the current candidate vaccines
deserve to be tested in large-scale
trials." This section is footnoted
to the article refered to above.
Both
articles, along with various conference
interventions, track back to yet another
crusading text, published by Heyward and
Dr Jose Esparza, HIV vaccine coordinator
at UNAIDS and the World Health
Organization. [Jose Esparza was later to
attempt a crucial intervention for the
company in February 2003, spinning the
failure of VaxGen's phase III trial as a
success.] In the journal Aids
in 1996 (10(auppl A, s123-132) the two
men used their prestige to campaign for
trials thus:
"Some
proponents feel that further basic
research is needed and maintain that
efficacy trials should not be initiated
until we have a better understanding of
the immune correlates of protection
against HIV infection in humans, and new
candidate vaccines are developed based on
such information. Others argue that some
of the existing candidate vaccines based
on envelope recombinant proteins have
been shown to induce protective immunity
in chimpanzees, are safe and immunogenic
in Phase I/II trials in humans, and are
reasonable candidate vaccines available
now for Phase III efficacy trials. In
this article we propose that a parallel
development process - additional basic
research of different vaccine concepts in
close interaction with vaccine efficacy
trials - may represent the most rational
approach to accelerate the process of HIV
vaccine development."
Only
one phase III trial was to happen in the
forseeable future: that of VaxGen's
AidsVax, which later featured in the 1999
Sunday Times investigation The VaxGen
Experiment by Brian Deer. Under
Heyward's leadership, CDC lobbied other
government agencies to support VaxGen,
allocated $8m in CDC grants to the phase
III and gave the company vital
credibility with private investors. But
Heyward was secretly engaged to join the
company as vice-president, and after Deer
supplied documents to the federal
inspector general for health and human
services, Heyward was prosecuted and
plea-bargained a $32,500 fine.
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