-Caveat Lector- http://www.cnn.com/2000/HEALTH/11/01/study.funding/index.html Doctor-drug conflicts of interests splashed across JAMA pages November 1, 2000 Web posted at: 9:03 a.m. EST (1403 GMT) ATLANTA, Georgia (CNN) -- A public dispute has erupted between the manufacturer of an HIV medication and researchers who say the anti-HIV drug doesn't work. The fight, between The Immune Response Corp. (IRC) and doctors at the University of California at San Francisco, puts millions of dollars at stake. "The sponsor, by filing an arbitration action against me and the university, is trying to intimidate us from publishing our results, and that won't work," said Dr. James Kahn. Kahn is the lead author of a study of 2,527 HIV-positive patients nationwide, which found the drug in question -- when added to drug regimen for those patients -- failed to decrease the number of deaths and illnesses due to HIV. The drug carries the brand name Remune and is made by IRC. Kahn's findings appeared in Wednesday's editions of the Journal of the American Medical Association. The study was funded, in part, by Carlsbad, California-based IRC. The company, however, contends Kahn and others omitted favorable data and skewed the results. IRC had entered into an arbitration process during which it pushed for changes in the manuscript to make it "more balanced," said Dr. Ronald Moss, the company's vice president of medical and scientific affairs. IRC President Dennis Carlo did not dispute that Remune failed to reduce the number of deaths or illness due to HIV. However, he said the researchers omitted data showing that patients on Remune had lower levels of virus in their blood than patients on a placebo. The study was performed at 77 medical centers. Some of the doctors involved with the study agree with the drug company that pertinent information was not included in the published report. They say Remune has helped their patients. But other doctors involved in the study, including Dr. Kahn, contend the Remune users did not have lower levels of the virus in their blood. Kahn also said IRC tried to suppress publication of his findings, which the company denies. In an arbitration complaint filed last month, IRC demanded $7 million to $10 million from Kahn and the university, claiming dissemination of the negative findings caused it financial harm. The arbitration action shocked the editors at JAMA and others, and sparked an ethical debate about private companies funding medical research. "It makes me very angry that ethical investigators are now faced with a multi-million dollar lawsuit," said Dr. Jerome Kassirer, a former editor of the New England Journal of Medicine who called IRC actions "outrageous." Besides Kahn's study, other findings, articles and editorials published in Wednesday's JAMA take issue with the growing trend of academic research being funded by private industry. Many experts worry that science is being compromised by money and, if the trend continues, more disputes will arise. CNN correspondent Elizabeth Cohen and The Associated Press contributed to this report. � 2000 Cable News Network. All Rights Reserved. ============================ http://jama.ama-assn.org/issues/current/abs/joc01590.html Policies on Faculty Conflicts of Interest at US Universities Mildred K. Cho, PhD; Ryo Shohara; Anna Schissel, MBioethics; Drummond Rennie, MD Context Despite federal regulations on faculty conflicts of interest in federally funded research, academic-industry ties are common, and evidence exists that financial considerations bias the research record. Public scrutiny of these ties is increasing, especially in cases where researchers have financial interests in the corporate sponsors of their clinical research. Objective To review policies on conflict of interest at major biomedical research institutions in the United States. Design Cross-sectional survey and content analysis study conducted from August 1998 to February 2000. Setting and Participants The 100 US institutions with the most funding from the National Institutes of Health in 1998 were initially sampled; policies from 89 institutions were available and included in the analysis. Main Outcome Measures Process for disclosure, review, and management of conflicts of interest and specified management strategies or limitations, according to the institutions' faculty/staff conflict of interest policies. Results Content of the conflict of interest policies varied widely across institutions. Fifty-five percent of policies (n = 49) required disclosures from all faculty while 45% (n = 40) required them only from principal investigators or those conducting research. Nineteen percent of policies (n = 17) specified limits on faculty financial interests in corporate sponsors of research, 12% (n = 11) specified limits on permissible delays in publication, and 4% (n = 4) prohibited student involvement in work sponsored by a company in which the faculty mentor had a financial interest. Conclusions Most policies on conflict of interest in our sample of major research institutions in the United States lack specificity about the kinds of relationships with industry that are permitted or prohibited. Wide variation in management of conflicts of interest among institutions may cause unnecessary confusion among potential industrial partners or competition among universities for corporate sponsorship that could erode academic standards. It is in the long-term interest of institutions to develop widely agreed-on, clear, specific, and credible policies on conflicts of interest. JAMA. 2000;284:2203-2208 View Full Text Author/Article Information Author Affiliations: Stanford University Center for Biomedical Ethics, Stanford, Calif (Dr Cho); University of California, San Francisco, Institute for Health Policy Studies (Mr Shohara and Dr Rennie); and New York University School of Law, New York, NY (Ms Schissel). Dr Rennie is also Deputy Editor, JAMA. Corresponding Author and Reprints: Mildred K. Cho, PhD, Stanford University Center for Biomedical Ethics, 701 Welch Rd, Suite 1105, Palo Alto, CA 94304 (e-mail: [EMAIL PROTECTED]). � 2000 American Medical Association. All rights reserved. <A HREF="http://www.ctrl.org/">www.ctrl.org</A> DECLARATION & DISCLAIMER ========== CTRL is a discussion & informational exchange list. Proselytizing propagandic screeds are unwelcomed. Substance�not soap-boxing�please! 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