December 2001 Bulletin

Understanding the dilemma created by industry’s support of orthopaedic surgeons

Under what circumstances, if any, is it appropriate for orthopaedic surgeons to accept gifts from industry? It’s not a new question and it’s not easily addressed. The AAOS first tried to answered the question in 1992, with the AAOS "Opinion on Ethics on Gifts and the Orthopaedic Surgeon’s Relationship with Industry." The opinion has been updated several times, most recently in 1997.

Industry support of CME events is widespread, along with the knowledge that many orthopaedic surgeons are offered and accept subsidies to attend such events. Regulations governing industry support of CME events have been developed by the Accreditation Council of Continuing Medical Education (ACCME) and the Food and Drug Administration (FDA) as a safeguard to decrease the risk of bias and to maintain complete independence regarding course content, faculty and design. Non-CME courses are purely commercial, biased and subject to regulation under the labeling and advertising provisions of the Federal Food, Drug and Cosmetic Act.

The value and necessity of continuing education is undisputed. Without the ongoing process of self-improvement, the orthopaedic surgeon is not fulfilling his/her ethical obligation to act in the patient’s best interest. Because of shrinking availability of funding, there has been a considerable increase in industry funded educational events, research, and program development. There is a dilemma, however, which springs from the fact that industry often offers participants subsidies for travel, meals, housing and registration, and may offer samples of products and participation in recreational activities.

Should orthopaedists refuse subsidies, gifts and honoraria, viewing them as marketing devices aimed at swaying their independent judgments? Are the subsidies a quid pro quo, obligating orthopaedists to use one device or pharmaceutical over another? Should orthopaedists use their own judgment on whether or not they are being influenced by the subsidies or should guidelines be developed?

The Academy’s current opinion, reflecting a growing concern about certain gifts from industry to orthopaedic surgeons, states directly, that gifts may be marketing devices designed to promote the use or purchase of equipment and, therefore, may not be consistent with basic principles of medical ethics. To avoid acceptance of inappropriate gifts, the Opinion states that orthopaedists should not accept anything of value from industry unless it primarily benefits patients and is not of "substantial" value (e.g., $100 or more). While subsidies to underwrite the costs of CME courses and other professional meetings are acceptable, orthopaedists should not accept subsidies for travel, lodging or personal expenses.

Reporting to the Board of Directors in February, the Ethics Committee noted that it has been grappling with this issue for the past several years because a large number of practicing orthopaedists are in conflict with the opinion.

Ultimately, The Ethics Committee recommended that the Board adopt a new Opinion, citing three reasons:

The AMA maintains that travel expenses and honoraria should not be paid to physicians. However, the AMA comments, "Medical specialties are in a better position to advise physicians regarding reimbursement for these trips. When the company insists the visits are a means of protection from liability for improper usage, physicians and their specialties should make the judgment. In no case are honoraria appropriate and travel expenses should be only those strictly necessary."

Action on the Ethics Committee’s request was deferred until this month’s Board meeting. In the meantime, the Board of Councilors (BOC) and COMSS considered the issue at a meeting in October.

Different aspects of the issue were presented by Jeanne DelSignore, MD, Ethics Committee chair, who compared the draft Opinion with the current Opinion; Audiey Kao, MD, acting vice president of ethics standards, AMA; Roy Crowningshield, PhD, senior vice president and chief scientific officer, Zimmer, Inc.; and Robert Orsetti, president, International Center for Postgraduate Education at Jobson Publishing.

Six breakout sessions, attended by members of the BOC, COMSS, the AAOS Board and several representatives of the state orthopaedic societies, considered three issues:

David Halsey, MD, BOC chair, was enthusiastic about the assignment, saying it fit the BOC’s role of "taking substantive issues and getting diverse input for the fellowship." He is confident the conclusions will help the Ethics Committee modify the draft opinion.

In the end, Dr. Halsey concluded that while there is a wide range of views on orthopaedists’ relations with industry, many believe that orthopaedists have good judgment and will act in the best interests of their patients. He observed that there was consensus that the AMA position on gifts was too restrictive. An organization "needs to set the bar high, but it should be attainable by more than 1 percent of the group," he observed.

So what is the standard that the AAOS will establish in 2001?

Dr. DelSignore and the ethics committee concur that the current AMA position statement is too restrictive and that it is not consistent with current practice by a large percentage of practicing orthopaedic surgeons. The ethics committee acknowledges that it is appropriate for industry to provide financial and other support to Orthopaedic surgeons if such support has significant educational value, improves patient care, and is able to withstand public scrutiny. While subsidies by industry to underwrite the costs of CME events are acceptable, such events must follow the ACCME and FDA guidelines. It is appropriate for faculty or those providing genuine consulting services to receive honoraria and expense reimbursement.

Ethics committee members do believe that a potential conflict of interest exists whenever an Orthopaedic surgeon receives a gift from industry, regardless of the size. Although altruism is more common among physicians than among most other professions, there must be an acute awareness of the potential for loss of professionalism and erosion of patient trust in this new era. Given the knowledge that industry plays a major role in supporting continuing education events, the committee believes that the opinion statement should reflect current practice and should provide guidelines to assist the membership with making appropriate decisions. Orthopaedic surgeons should never lose sight of their primary ethical responsibilities to provide competent, compassionate patient care, maintaining professionalism and objectivity at all times.

Richard H. Gelberman, MD

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