-----Mensagem original----- De: owner-lbo-talk at lists.panix.com [mailto:owner-lbo-talk at lists.panix.com]Em nome de Doug Henwood Enviada em: quarta-feira, 1 de novembro de 2000 16:05 Para: lbo-talk Assunto: suing a med journal
Chronicle of Higher Education - web daily - November 1, 2000
Pharmaceutical Company Challenges Researchers' Finding That Drug Doesn't Counter HIV By KATHERINE S. MANGAN
A drug manufacturer is demanding up to $10-million from an AIDS researcher and the University of California at San Francisco over a study published in today's issue of The Journal of the American Medical Association that concluded that the company's drug is ineffective against H.I.V., the virus that causes AIDS.
The company, Immune Response Corporation, filed an action with the American Arbitration Association this week, accusing James O. Kahn of omitting favorable data in his report. The company, which paid for the study, also charged that he violated an agreement to keep the findings confidential.
Dr. Kahn, an associate professor of medicine at U.C.S.F., countered that the company is trying to intimidate him into withholding his findings. He said that the university's agreement with Immune Response allowed it to publish the findings, and that the company withheld final data from the researchers.
"They're like bullies in a sandbox who take away their toys when you don't agree with them," Dr. Kahn said in an interview Tuesday.
The other lead author was Stephen W. Lagakos, a professor of biostatistics at Harvard University's School of Public Health. He was out of the country and unavailable for comment.
The study, begun in 1996, involved 2,527 H.I.V.-infected patients in 77 medical centers in the United States. The authors concluded that H.I.V.-1 Immunogen, which also goes by the brand name Remune, had no effect in slowing progression of the disease into full-blown AIDS.
Immune Response officials countered that a small group of patients who were given more-frequent doses did improve, but that Dr. Kahn omitted that information.
Dr. Kahn said that's not true. "The patients trusted us to independently analyze the data and determine whether it would help them," he said. "We answered that it doesn't help -- it's no different than a placebo. Let's move on and find something that does help."
An official with the drug company said he's still optimistic the drug will ultimately be approved by the U.S. Food and Drug Administration.
"We're hoping we'll survive this and that there will be data in the near term that will suggest that these guys were dead wrong," said Ronald B. Moss, vice president for medical and scientific affairs. Dr. Moss is also an assistant clinical professor of medicine at the University of California at San Diego.
The new issue of JAMA, in which Dr. Kahn's findings are outlined, is devoted to conflicts of interest in medical research. Of 100 research-intensive medical schools studied, 55 percent required all faculty members to disclose potential conflicts, while 45 percent required them from principal investigators only. Nineteen percent of the policies set limits on faculty financial interests in companies that sponsored research.
-This seems to be very serious. If researchers are subject to those risks, -then marketing will be briefly substituted for serious research. As medical -oncologist, I´m somewhat frightened by the way pharmaceutical companies are -forcing us to accept new (and expensive) therapies as standard treatments -withouth clear evidence of benefits, in many stances based on works -published as Abstracts in Medical meetings (so we can´t get access to -details of methodology used). The former rigis FDA seems to be inolved in -this bullshit too, since it approved Paclitaxel to be used as adjuvant -therapy in breats cancer based in a study with a ridiculous follow up -period.....
Alexandre Fenelon