Many U.S. medical schools are willing to give companies that sponsor
studies of new drugs and treatments considerable control over the
results, according to survey results that some doctors found
troubling.
Half of the schools said they would let pharmaceutical companies and
makers of medical devices draft articles that appear in medical
journals, and a quarter would allow them to supply the actual results.
But academics draw the line at gag orders that keep researchers from
publishing negative findings.
"This is totally beyond reasonable practice. What you're seeing here
is a willingness by some institutions to give more leeway than they
should," said Dr. Harlan Krumholz, a Yale University cardiologist and
epidemiologist who was not involved in the survey.
Private industry funds more than two-thirds of medical research at
U.S. universities, a situation that has led increasingly to
conflict-of-interest suspicions. Two decades ago, the federal
government was the main benefactor.
The study, led by Michelle Mello of the Harvard School of Public
Health, appears in Thursday's New England Journal of Medicine.
Harvard researchers sent surveys to the nation's 122 accredited
medical schools to gauge what kinds of standards exist between
researchers and sponsors. All but 15 responded.
The researchers did not directly establish exactly how much control
universities actually give to companies.
But the medical schools overwhelmingly agreed that they would not
enter into contracts that would allow companies to edit research
articles or suppress negative results. The schools were split on other
issues. Fifty percent would allow companies to draft research papers,
while nearly 25 percent would let them provide the data.
Three-fourths had disputes over payment after a contract was signed,
and 17 percent argued over access to data.
"These results are really bothersome," said Dr. Jerome Kassirer,
former editor in chief of the journal and author of a recent book
about conflict of interest in research. "Some investigators may be
willing to accept constraints just to maintain good relations with the
company," said Kassirer, who had no role in the survey.
The Pharmaceutical Research and Manufacturers of America, a trade
group, insists that corporate sponsors do not interfere with
researchers' independence.
The group publishes voluntary research guidelines stating that
companies will sometimes help analyze and interpret results and have
the right to review articles before publication. The guidelines also
note that sponsors own the data and have sole discretion over who has
access to the information.
Recent controversies involving companies accused of suppressing
unfavorable results have led to demands for more public disclosure of
industry-sponsored research. Drug manufacturers GlaxoSmithKline and
Merck were recently accused of hiding information about the
antidepressant Paxil and the painkiller Vioxx, respectively.
An accompanying editorial noted several efforts under way to change
the situation, among them:
_The American Medical Association is working with the industry to
eliminate gag clauses in research contracts.
_The Association of American Medical Colleges is developing a set of
principles for researchers and sponsors of studies.
_A bill is pending in Congress that would require public and private
sponsors to register their studies in a government database.
_Eleven members of the International Committee of Medical Journal
Editors last year promised not to publish any studies not registered
in the database.
Source Given From: Misc.health.alternative
# posted by madthumbs @ 4:46 PM
