The profession of medicine is grappling with a wide spectrum of
conflict-of-interest issues, particularly in terms of relationships with the
pharmaceutical and medical-device industries. The Institute of Medicine's
(IOM) Committee on Conflict of Interest in Medical Research, Education, and
Practice has held multiple public meetings with stakeholders within and
outside of medicine to evaluate these relationships and to learn how they
affect the education, practice, research, ethics, and professionalism in
At a public meeting on March 13 organized by the IOM, representatives from
consumer advocacy groups, the pharmaceutical and medical-device industries,
medical schools, professional associations, and a medical journal presented
their assessments of the current situation and offered opinions and
recommendations for national guidelines for resolving or managing conflict of
interest in medicine. The committee's intent was to "gather
information" and "review a variety of perspectives,"
according to the IOM Committee chair. APA President Carolyn Robinowitz, M.D.,
and others gave testimony representing the perspective of physician membership
Almost all participants at the meeting used the word"
ubiquitous" to describe the relationships with pharmaceutical and
device industries in various areas of medicine—from training to
Some of these relationships have been highly publicized. Industry funds
preclinical and clinical research conducted at medical schools and
institutions; provides free lunches to students, residents, and practitioners
who attend educational seminars and continuing medical education (CME)
courses, seminars, and symposia; gives money to foundations and organizations
for patients with certain diseases; and advertises and exhibits at
professional association meetings. Industry marketing representatives
frequently interact with physicians, including those in training, and give
them promotional materials as well as small gifts like pens and pads.
Physicians receive information about drugs and medical devices from the
manufacturers, including journal article reprints. At least half of all CME is
funded by educational grants from industry (see Medical Schools Grapple With
Some relationships between industry and medicine are indirect and less
apparent. Faculty members who teach students and residents may be involved in
industry-sponsored clinical or nonclinical research. Experts who serve as
consultants or speakers for companies may be authors of therapeutic guidelines
and advisors to the Food and Drug Administration (FDA). Universities may have
patented and sold technologies to industry for development, while receiving
While relationships with industry are common, opinions differed, however,
on when such relationships constitute conflict of interest and which
relationships are beneficial or detrimental to medicine and public health. A
number of participants pointed out that not all relationships present
conflicts of interest or lead to negative consequences.
Industry funding, licensing, and collaboration are mostly beneficial to
academia in discovery research, said Joseph Martin, M.D., Ph.D., a former dean
of Harvard Medical School, and Philip Pizzo, M.D., current dean of Stanford
University Medical School. Too much restriction on industry funding for
research, they believe, would stifle innovation in the current environment of
flat or declining funding by the National Institutes of Health (NIH).
John Walsh, president of the Alpha-1 Foundation, told the IOM committee
that the foundation relies on industry funding for research and patient-aid
activities in rare diseases. The Alpha-1 Foundation is a nonprofit devoted to
finding resources for research in alpha-1 antitrypsin deficiency, a rare
genetic disease. To make treatment available to patients with rare diseases,
the FDA cannot afford to exclude all experts with ties to the industry from
advisory committees, because there are usually few experts in the field. Many,
if not most, experts are involved in research sponsored by industry because of
a scarcity of other funding sources.
"It would be irresponsible to take away the expertise and limit the
number of experts on an advisory committee that have potential conflict of
interest," Walsh commented.
Unlike in academic research, several presenters expressed greater concerns
about the industry's involvement in direct patient care and medication
education. Mark Levine, M.D., chair of the AMA's Council on Ethical and
Judicial Affairs, said that the AMA has long been concerned about the issue of
conflict of interest in medical education and how it may be eroding
professionalism. The gifts, lunches, and frequent contact with pharmaceutical
representatives "create a culture of entitlement" in educational
settings that has troubled the AMA. Small gifts can create a favorable
relationship between company representatives and practicing physicians that
may influence clinical decisions in a subtle and subconscious way.
Many meeting participants, including representatives from the
Pharmaceutical Research and Manufacturers of America, Biotechnology Industry
Organization, and a medical-device association, believe disclosure of
potential conflicts is the key to preventing problems related to conflict of
interest in medicine.
Representatives from consumer groups, including Consumers Union and the
Center for Science in the Public Interest, strongly advocated for complete
disclosure of all relationships each medical professional has with industry.
They recommended that all pharmaceutical and device companies release
information about how much money they pay which physicians and for what, so
that consumers can find out what types of relationships their own physicians
have with industry.
Disclosure has become the standard in peer-reviewed biomedical journals,
according to Harold Sox, M.D., the editor of Annals of Internal
Medicine. Most major publications require authors and reviewers to
disclose fully anything that may potentially cause bias and leave it to the
readers to weigh the evidence presented. Sox admitted, however, that journal
editors do not have the means to verify every disclosure, and intentional
omissions have happened.
For patients who seek health care and physicians who read clinical
guidelines, however, disclosure alone may not be particularly useful.
"Disclosure... assumes that people being disclosed to can deal with
this information rationally," said the AMA's Levine. "Disclosure
does not eliminate conflict of interest, but sometimes can have a perverse
effect of perpetuating it." Can average patients differentiate between
their physicians' consulting contract and research collaboration with
Consumer groups have called for the prohibition of all potential conflict
of interest in medical education, CME, the FDA approval process, and clinical
guidelines. They also called for increased government funding for
Others disagreed that prohibition is a realistic solution. The Alpha-1
Foundation, for example, pools industry donations and distributes the funds to
researchers without ties to specific products. Industry representatives stated
that current rules and guidelines issued by the FDA and other regulatory
agencies, if consistently enforced, are sufficient to guard against conflict
of interest. Several participants noted that industry funding is supporting
many efforts at smaller hospitals and departments that would not have been
possible without it.
Robinowitz described to the IOM committee the strict standards adopted by
APA to prevent conflict of interest. For example, all DSM-V task
force members are required to have no more than $10,000 derived from industry
sources (excluding unrestricted research grants) during any calendar year as
long as they are on the task force, "a policy more stringent than the
limits for NIH employees and FDA advisory committee members." A similar
policy applies to practice guidelines issued by APA.
Representatives from several other medical associations pointed out that
the most an association can do to unethical practitioners is revoke their
membership. Beyond that, their power is limited to education and raising
awareness because a large proportion of physicians do not belong to
professional organizations. At most, professional organizations can report
inappropriate conduct to the licensing board.
Participants generally agreed that the medical profession is losing public
trust because of conflict-of-interest problems. The frequent scandals reported
in the lay media are creating a perception that physicians place their gains
from relationships with industry above patients' well-being. Industry
representatives also acknowledged the risk of losing public trust and the need
for increased transparency. However, many participants were wary of more
regulations that may require universities and hospitals to police their
employees' financial and other relationships with the industry.
The IOM committee noted that its final report and recommendations will be
released in the fall. ▪