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"Protecting the health and informed consent rights of children since 1982."

February 6, 2002 NY Times
Study Says Clinical Guides Often Hide Ties of Doctors

WASHINGTON, Feb. 5 - A survey of medical experts who write guidelines for
treating conditions like heart disease, depression and diabetes has found
that nearly 9 out of 10 have financial ties to the pharmaceutical
industry, and the ties are almost never disclosed.
It has long been known that contact with the pharmaceutical industry can
influence individual doctors' prescribing patterns and that financial
support from drug manufacturers can affect the course of academic
But the survey, a relatively small study conducted by a team from the
University of Toronto, is the first to document the extent to which the
industry may influence so-called clinical practice guidelines. These
voluntary guidelines, which are typically published in medical journals
and endorsed by medical societies, set standards that are followed by
countless doctors.
"These clinical protocols should be seen by the public as unbiased," said
Sheldon Krimsky, a health policy expert at Tufts University who has
written extensively on financial conflicts of interest. "The fact that
there is a veil of secrecy over most of these does not bode well for a
clinical community which is trying to ensure trust in the public."
The survey, in this week's issue of The Journal of the American Medical
Association, sought the opinions of 192 medical experts who participated
in writing 44 sets of practice guidelines covering treatment for asthma,
coronary artery disease, depression, diabetes, high cholesterol,
pneumonia and other ailments.
Of the 100 who responded, roughly 9 out of 10 had some type of financial
relationship with a drug manufacturer, including research financing and
speaking, travel or consulting fees. About 6 out of 10 had financial ties
to companies whose drugs were either considered or recommended in the
guidelines they wrote.
Eleven of the 44 practice guidelines were underwritten by pharmaceutical
companies and carried declarations stating so. But of the 44 guidelines,
just one reported a potential conflict of interest.
"That's a problem," said Dr. David Blumenthal, a health policy expert at
Harvard Medical School who has written about financial conflicts in the
medical profession. "This is just emblematic of the extensive, often
undisclosed relationships that exist between medical experts and
pharmaceutical companies."
Financial conflicts of interest are the subject of intense debate in
medicine. Pharmaceutical companies often underwrite the cost of medical
conferences and hire prominent academic doctors to serve as speakers or
to lead symposiums at which the companies' drugs are discussed.
Proponents say the companies are helping to educate doctors. But critics
have complained that such financial relationships jeopardize the
integrity of scientific research. This week, more than two dozen
prominent scientists and doctors sent a letter to more than 200
scientific journals urging them to strengthen their requirements for
disclosing conflicts of interest.
Among those who signed is Dr. Marcia Angell, the former editor of The New
England Journal of Medicine. In an interview today, Dr. Angell said that
disclosing financial ties to industry was the least doctors could do and
added that in most cases, the ties should be simply severed.
"Most consulting arrangements are simply a way for researchers to make
money and the industry to buy their good will," Dr. Angell said.
"Researchers serve on advisory boards and speakers' boards, and they
travel around the world, ostensibly to educational programs. But really,
they are just enriching themselves, and the drug companies retain
influence over them to a remarkable extent."
Others, including Dr. Allan S. Detsky, an author of the Toronto study,
take a less stringent view, arguing that conflicts should be made public
and that doctors should discuss them openly before writing guidelines.
"It's not possible to stamp this out," Dr. Detsky said. "The answer is to
sensitize people to accept that it's a problem."
Only 7 percent of the doctors in the Toronto study said they believed
that their relationships with industry influenced their recommendations,
although 19 percent said financial ties influenced the recommendations of
their colleagues.
A spokesman for the Pharmaceutical Research and Manufacturers
Association, an industry trade group, said today that the organization
was not opposed to doctors' disclosing their ties with industry.
But the spokesman, Jeff Trewhitt, said drug companies did not want to see
doctors with drug industry ties excluded from writing guidelines.
"Too many exclusions would mean not allowing some well-respected experts
to work on these important guidelines," Mr. Trewhitt said.
February 6, 2002 JAMA

Relationships Between Authors of Clinical Practice Guidelines and the
Pharmaceutical Industry

Niteesh K. Choudhry, MD, FRCPC; Henry Thomas Stelfox, MD, FRCPC; Allan S.
Detsky, MD, PhD, FRCPC

Context: Increasing contact has been reported between physicians and the
pharmaceutical industry, although no data exist in the literature
regarding potential financial conflicts of interest for authors of
clinical practice guidelines (CPGs). These interactions may be
particularly relevant since CPGs are designed to influence the practice
of a large number of physicians.

Objective: To quantify the extent and nature of interactions between
authors of CPGs and the pharmaceutical industry.

Design, Setting, and Participants: Cross-sectional survey of 192 authors
of 44 CPGs endorsed by North American and European societies on common
adult diseases published between 1991 and July 1999. One hundred authors
(52%) provided usable responses representing 37 of 44 different CPGs that
we identified.

Main Outcome Measures: Nature and extent of interactions of authors with
drug manufacturers; disclosure of relationships in published guidelines;
prior discussion among authors regarding relationships; beliefs regarding
whether authors' own relationships or those of their colleagues
influenced treatment recommendations in guidelines.

Results: Eighty-seven percent of authors had some form of interaction
the pharmaceutical industry. Fifty-eight percent had received financial
support to perform research and 38% had served as employees or
consultants for a pharmaceutical company. On average, CPG authors
interacted with 10.5 different companies. Overall, an average of 81% (95%
confidence interval, 70%-92%) of authors per CPG had interactions.
Similarly, all of the CPGs for 7 of the 10 diseases included in our study
had at least 1 author who had some interaction. Fifty-nine percent had
relationships with companies whose drugs were considered in the guideline
they authored, and of these authors, 96% had relationships that predated
the guideline creation process. Fifty-five percent of respondents
indicated that the guideline process with which they were involved had no
formal process for declaring these relationships. In published versions
of the CPGs, specific declarations regarding the personal financial
interactions of individual authors with the pharmaceutical industry were
made in only 2 cases. Seven percent thought that their own relationships
with the pharmaceutical industry influenced the recommendations and 19%
thought that their coauthors' recommendations were influenced by their

Conclusions: Although the response rate for this survey was low, there
appears to be considerable interaction between CPG authors and the
pharmaceutical industry. Our study highlights the need for appropriate
disclosure of financial conflicts of interest for authors of CPGs and a
formal process for discussing these conflicts prior to CPG development.
JAMA. 2002;287:612-617

Author Affiliations: Departments of Medicine (Drs Choudhry, Stelfox, and
Detsky) and Health Policy, Management and Evaluation (Dr Detsky),
University of Toronto, and Department of Medicine, University Health
Network and Mount Sinai Hospital (Drs Choudhry and Detsky), Toronto,
Ontario; and the PhD Program in Health Care Policy, Harvard University,
Boston, Mass (Drs Choudhry and Stelfox). Corresponding Author and
Reprints: Allan S. Detsky, MD, PhD, FRCPC, Mount Sinai Hospital, Room
427, 600 University Ave, Toronto, Ontario, Canada M5G 1X5.

Disclaimer:  This study received no financial support from the
Acknowledgment: We thank the guideline authors, in particular those who
responded to 2 surveys and those who participated in interviews, for
their assistance and honesty. We are also indebted to Darren Merker,
Kevin Lumb, Kevin Schwartz, Heather Smith-St. Kitts, and Kimberley
Britnell for their invaluable assistance with data collection and survey

Financial Disclosures: Drs Choudhry and Stelfox have attended numerous
Department of Medicine educational rounds sponsored by the pharmaceutical
industry. Dr Detsky has received honoraria for speeches, consulting fees,
and research grants from pharmaceutical manufacturers.
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