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Experts Disagree on Impact of Medicine, Industry Relationship

The presence of the pharmaceutical and device industries is felt in all corners of medicine. Media attention to conflicts of interest and industry-medical relationships puts increasing pressure on the profession to reform.

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 medicine.

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 associations.

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 practice.

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 Drug-Industry Influence).

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 handsome royalties.

Relationships Versus Conflicts of Interest

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.

Is Disclosure the Solution?

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 industry?

Mitigation or Prohibition?

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 research.

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.

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