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By Susan Okie
Editors at the world's most prominent
medical journals, alarmed that drug companies are exercising
too much control over research results, have agreed to adopt
a uniform policy
that reserves the right to refuse to publish drug company-sponsored
studies unless the researchers involved are guaranteed scientific
independence.
The New England Journal of Medicine, the
Lancet, the Annals of Internal Medicine and the Journal of
the American Medical Association (JAMA) are among the journals
that have agreed to publish a joint editorial in mid-September
outlining the new policy, which was drafted by a committee
of editors over the last several months.
The unprecedented move could have a significant
impact on how medical research is conducted and
reported by giving researchers more leverage in their dealings
with the pharmaceutical industry. Companies are eager to publish
studies in these prestigious journals because doctors view
them as credible sources of information to help them decide
which drugs to prescribe to patients.
Editors said the new policy is a response
to companies' increasingly tight
hold over how research is done -- and, in many
cases, over whether and how the results are made public. In
recent years, drug companies have become the dominant funder
of biomedical research, especially of large studies of medicines'
safety and effectiveness.
The authors who receive top billing on
drug studies published in respected, peer-reviewed journals
are usually medical school professors who are experts in their
fields, but much of the research is paid for, and in large
measure carried out, by companies with an enormous financial
stake in the outcome. Company employees usually collect and
analyze the data, and they often decide how it should be presented
and write the reports.
The journal editors decided to act after
several recent cases involving charges that drug
companies tried to withhold research results or present them
in the most favorable way, several said during
interviews last week.
"It's become a huge problem,"
said Frank Davidoff, who as editor of the Annals of Internal
Medicine was among those who decided to take a stand on the
issue at an international meeting of medical journal editors
in May in Philadelphia.
Catherine D. DeAngelis, the editor of
JAMA, said her journal already has a policy of demanding that
study authors vouch for the integrity of their data. "The
goal would be that all of the major journals would adopt similar
. . . principles," she said.
Jeffrey M. Drazen, editor in chief of
the New England Journal of Medicine, confirmed that the editorial
is to be published in mid-September but declined to discuss
its content other than to say "it's an important issue."
The decision was praised by several observers
of biomedical studies who have become alarmed
about the influence of the drug industry on the
integrity of medical research.
In large, company-sponsored drug trials
involving multiple hospitals, all of the information collected
is typically held by the company, said Marcia Angell, former
editor in chief of the New England Journal of Medicine. "Not
even the principal author sees all the data," she said.
As editor of the journal, Angell recalled,
she sometimes received manuscripts from company-sponsored
studies that had the "methods" section -- the explanation
of how the study was carried out -- left blank.
"They'd say, 'This is proprietary,' " she said.
Surveys of the medical literature have
shown that studies paid for by drug companies are more
likely than those with other sponsors to show
results favorable to the product tested, said Lisa
Bero, a professor of clinical pharmacy and health policy at
the University of California at San Francisco.
Many medical schools include clauses in
grant agreements with companies stating that researchers will
be free to publish even if the results are negative. "But
even if you have one of those, you can still get hassled,
still get pressure put on you for fear that you won't get
any future funding," Bero said.
Robert J. Temple, director of medical
policy at the Food and Drug Administration's Center for Drug
Evaluation and Research, said, "One of the things I learned
a long time ago is that the person who writes the rough draft
has a lot of control.
"What the journals have to figure
out is, if that's the way it's done, should it be explained
that way? Should the senior author say, 'This was drafted
for me, but I believe it?' " he said.
The journal editors decided to issue the
joint editorial in response to "three or four well-known
egregious examples, and many less well-known" cases in
which companies tried to block
publication of unfavorable studies or tried to
put a positive spin on the findings, said Davidoff, who stepped
down as editor of the Annals in July.
In a case last year, researchers at the
University of California at San Francisco defied a corporate
sponsor by publishing a study concluding that Remune, a vaccine-like
product developed as an HIV therapy, did not benefit patients
who were already receiving standard treatments. The company,
Immune Response Corp. of Carlsbad, Calif., is seeking $7 million
to $10 million in compensatory damages from the university
for harming its business.
University of Toronto physician Nancy
Olivieri lost her research contract with Apotex Inc., a Canadian
drug company, after she spoke out and published an article
in 1998 about a serious side effect of deferiprone, a drug
for a blood disorder. Olivieri's contract with Apotex contained
a nondisclosure clause. Elie Betito, director of public and
government affairs for Apotex, said Olivieri's contract was
terminated because she failed
to follow the protocol specifying how the study
should be carried out, not because she published her findings.
In the early 1990s, UCSF pharmacologist
Betty J. Dong found that cheaper generic versions of thyroid
hormone worked as well as Synthroid, the brand-name drug whose
maker had funded the research. The company, Knoll Pharmaceuticals,
successfully blocked publication of Dong's findings for seven
years. In 1999, Knoll agreed to pay 37 states almost $42 million
to settle a suit alleging that it had made false claims that
Synthroid was superior to competing brands and had interfered
with the publication of the study.
James Wright, a professor of clinical
pharmacology at the University of British Columbia, predicted
that if medical journals
take a stand in favor of scientific independence,
it will have an impact on drug companies' behavior. "The
company wants [its drug] to be in one of these prestigious
journals," he said. "All they need to do is say,
'We won't publish it unless it has all the information.' "
Washington
Post August 5, 2001; Page A01
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