Doctors, Drug Maker Dispute AIDS Study

C H I C A G O, Oct. 31 -- A study suggesting a vaccine-like AIDS treatmentis ineffective has erupted in a public dispute between themanufacturer that paid for much of the study and doctors who saythe company tried to squelch their research.

The study is being published in Wednesday’s Journal of theAmerican 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 forHIV-infected patients, HIV-1 Immunogen failed to reduce the risk ofdeveloping full-blown AIDS. The drug carries the brand name Remune.

Immune Response Corp., the drug’s manufacturer, contendsresearchers 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 duringwhich it tried to produce “a more balanced manuscript,” said Dr.Ronald Moss, the company’s vice president of medical and scientificaffairs.

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Contract Violation?

Instead, the researchers violated their contractual agreementand published incomplete findings, Moss said.

“It seems like tabloid journalism that JAMA would notinvestigate this further” before publishing, Moss said.

HIV-1 Immunogen was developed by the late Dr. Jonas Salk, whocreated the first polio vaccine. It was developed before powerful“drug cocktails” including protease inhibitors became standardHIV treatment, and Immune Response says subjects’ use of such drugsaffected the findings in the JAMA study.