-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.

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