AIDS DRUG RESEARCHERS SAY
FIRM PRESSURED THEM
By Richard Saltus
Boston Globe 1 Nov. '00
It's just what traditionalists warned about as private investors took on an
ever-growing role in US medical research: the company that pays for a drug
study has the power to pressure scientists to make results look better than
That's exactly what scientists from Harvard University and the University of
California at San Francisco say happened to them when they tried to publish
results from a massive AIDS drug trial. Offering a rare look at the politics
behind modern science, the researchers say the biotech company that funded
their study tried to put a positive spin on the results, then, when that
failed, attempted to block publication altogether.
The study in its unaltered form appears in today's Journal of the American
Medical Association, but the fight is far from over. The company that funded
the study, Immune Response Corp., has filed a multimillion dollar binding
arbitration claim against the University of California and the lead
scientist, alleging damage to its business.
Officials of Immune Response ''really tried to stymie our efforts at
communicating with our colleagues,'' Dr. James O. Kahn, the study leader,
said in an interview. ''And finally they tried intimidation'' by filing the
arbitration action seeking monetary damages.
In their defense, officials at the Carlsbad, Calif.-based company deny
treading on scientific freedom. They say they tried in vain to get the
researchers to include data that the company felt were relevant - and that
some other researchers in the multicenter trial did, too. They say they only
resorted to legal action when that failed.
But, as the clashes between researchers and their private backers over
publication rights become more frequent, scientific organizations are
reacting with alarm.
Cases like this ''are a major, major concern to us,'' said Irving Lerch, who
heads a committee on Scientific Freedom and Responsibility for the American
Association for the Advancement of Science.
''There are too many that have hit the public spotlight to make me think
these are very rare events, and I think we have a problem we have to deal
with,'' said Dr. David Korn, an official of the American Association of
The study involved 2,500 patients infected with HIV, the virus that causes
AIDS, and was the largest AIDS drug trial of the 1990s. Immune Response,
founded by the late polio vaccine pioneer Jonas Salk, wanted to test its
''therapeutic vaccine'' called Remune.
The company's hope - and the hope of the scientists who tested it - was that
giving the vaccine to people infected with HIV would spur their immune
defenses to slow or halt the progression to AIDS.
In 1995, Kahn, an associate professor of medicine and AIDS specialist at UC
San Francisco, was chosen as the leader of a team that included Stephen
Lagakos and Deborah Weng Cheng, biostatisticians at the Harvard School of
Public Health, and Dr. Kenneth Mayer, an AIDS researcher at Brown
Begun in 1996, the research study was halted in 1999 when a monitoring
committee determined that patients who got the Remune injections were faring
no better than those who got standard antiviral drugs without Remune.
When it came time to write up the data for publication, Kahn, Lagakos, and
others on the team concurred that the analyses showed no benefit from the
drug. But scientists from Immune Response performed their own analysis of
blood tests on a sample of 250 patients in whom, the company argued, some
benefit could be seen - not in longer survival, but in having lower levels
of virus in their blood.
Dr. Ronald Moss, the company's medical director, argued that those data
should be part of the report manuscript.
''The Company never wanted to stop a publication - we just wanted it to be
representative of the viewpoints of the other clinical investigators, as
well as ours,'' Moss wrote in a statement. The goal was ''to present
information we felt was important to include to the scientific community,
and let people decide for themselves what the meaning was,'' he added in a
Kahn and the others, saying the analysis wasn't statistically sound,
''The sponsor wanted a specific small piece of data included that they think
shows their product works,'' Kahn said in an interview. ''We declined. We
didn't think it was a valid analysis.''
In response, the company demanded the right to approve the researchers'
manuscript before publication. They refused again.
Lagakos said: ''The company did not want our original analysis to go
forward. We were put in a position where we had to agree to terms that were
unacceptable to us. We decided to go forward with what we had.''
In September, Immune Response filed an action with the American Arbitration
Association that attempted to block publication of the report, and sought
damages of $7 million to $10 million from the university and Kahn.
The arbitration process has yet to begin, said Christopher Pitti, counsel
for the University of California.
The AIDS study is just the latest in a string of disputes over the past
several years pitting scientists' freedom of inquiry against rights asserted
by their employers or commercial sponsors. In some cases, the scientists
were required to sign ''nondisclosure'' agreements forbidding them to talk
about their findings for a specified period of time.
In one high-profile case, a pharmaceutical company suppressed a finding by
another UC San Francisco scientist that a popular thyroid drug, Synthroid,
was no better than cheaper rivals. The study, originally to be published in
1995, was withdrawn by the authors following legal threats by the company,
Knoll Pharmaceutical Co. It was finally published in 1997.