(AP) -- 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 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.
