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 their research.
The study is being published in Wednesday’s Journal of the American Medical Association.
The study in question refers to a trial that was stopped in May 1999, according to Laura Hansen, spokeswoman for the company. Other trials are ongoing with the vaccine, including one started in September 1999 with another company that is still enrolling 550 patients. Another National Institutes of Health study, which began earlier this year, is on hold, she said.
The results of the JAMA study 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.
Such data includes results showing that patients taking the vaccine and other new antiretroviral drugs had a decrease in the amount of virus in their blood compared to people who only took the drugs, Hansen says.
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 study.
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 suppress publication.
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.
Were Results Clinically Significant?
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 inaccurate information.”
The final manuscript contains “some major statistical flaws,” said Turner, who believes HIV-I Immunogen can slow disease progression.
“If I were HIV-positive, I would batter down any door necessary to get it, period,” Turner said.
ABCNEWS.com’s Robin Eisner and The Associated Press contributed to this report.