NEGATIVE STUDY PROMPTS CLAIMS OF
ATTEMPTS TO SUPPRESS RESEARCH
By Lindsey Tanner
AP 31 Oct. '00
Chicago -- A study suggesting a vaccine-like AIDS treatment is
ineffective has erupted in a public dispute between the manufacturer that
paid for much of the study and doctors who say the company tried to squelch
The study's conclusions, published in Wednesday's Journal of the American
Medical Association, echo doubts about HIV-1 Immunogen expressed several
years ago by advisers to the Food and Drug Administration.
The results suggest that when added to the drug regimen for HIV-infected
patients, HIV-1 Immunogen failed to reduce the risk of developing full-blown
AIDS. The drug carries the brand name Remune.
Immune Response Corp., the drug's manufacturer, contends researchers omitted
favorable data and skewed the results.
The company entered a fairly common arbitration process during which it tried
to produce "a more balanced manuscript," said Dr. Ronald Moss, the company's
vice president of medical and scientific affairs.
Instead, the researchers violated their contractual agreement and published
incomplete findings, Moss said.
"It seems like tabloid journalism that JAMA would not investigate this
further" before publishing, Moss said.
HIV-1 Immunogen was developed by the late Dr. Jonas Salk, who created the
first polio vaccine. It was developed before powerful "drug cocktails"
including protease inhibitors became standard HIV treatment, and Immune
Response says subjects' use of such drugs affected the findings in the JAMA
Dr. James Kahn of the University of California at San Francisco, the study's
lead author, said the company withheld important data and then tried to
The company denies both claims. In an arbitration complaint last month,
Immune Response also demanded $7 million to $10 million from Kahn and the
university, claiming dissemination of the negative findings caused it
financial harm, UCSF attorney Christopher Patti said.
The study of 2,527 patients nationwide found that Remune did boost levels of
infection-fighting white blood cells, but the authors questioned whether the
effect was clinically significant.
The university contends Kahn was allowed to publish the results.
JAMA editor Dr. Catherine DeAngelis defended the journal's decision to
publish. "This study stands on its own scientific merit," she said. "It was
peer-reviewed as such.''
In a JAMA editorial, she said the dispute illustrates what can happen when
disagreement erupts between researchers and a funding sponsor who "has a
proprietary interest in the findings."
Moss said the study was published without the consent of some of the
researchers. The company and one of the dissenting researchers, Dr. John
Turner of Graduate Hospital in Philadelphia, drafted a letter Monday to
DeAngelis, decrying publication of a manuscript that contains "incomplete and
The final manuscript contains "some major statistical flaws," said Turner,
who believes HIV-1 Immunogen can slow disease progression.
"If I were HIV-positive, I would batter down any door necessary to get it,
period," Turner said.