Book Review
Managing Relationships with Industry: A Physician's Compliance Manual
N Engl J Med 2009; 360:1366-1367March 26, 2009
- Article
Managing Relationships with Industry: A Physician's Compliance Manual
By Steven C. Schachter, William Mandell, Scott Harshbarger, and Randall Grometstein. 288 pp. Burlington, MA, Elsevier Academic Press, 2008. $39.95. ISBN: 978-0-12-373653-6The core assumption of Managing Relationships with Industry is that “with very few exceptions, physicians are ethical, patient-centered professionals.” Hence, the authors — three lawyers and one physician — aim to guide physicians who wish to avoid being embarrassed, disciplined, fined, or indicted because of their relationships with industry. Anyone who still believes that honesty can be established by declaring that a gift or payment, no matter how small, did not influence a decision had better consult this manual.
Although the authors invoke ethical principles, they are most intent on keeping physicians within legal boundaries. They most frequently discuss gifts, often citing recommendations of the task force that was appointed by the American Board of Internal Medicine (ABIM) Foundation and the Institute on Medicine as a Profession (IMAP), which I cochaired. They accurately summarize the task force's position that there should be a complete ban on gifts, as well as some of the reasoning behind it — mainly the extensive literature in the social sciences that relates gifts to bias in behavior. Indeed, the authors fully appreciate the power of gifts, quoting a former drug representative on how “incredibly effective” they are.
Nevertheless, the authors are impatient with the idea of an absolute ban. Almost every time the position is described, the next sentence begins with a “however,” and continues with a qualifying paragraph. The authors appear agnostic on the question of whether a gift “will unavoidably lead a doctor to act counter to her or her patient's best interest,” and they doggedly insist that drug representatives are “often an important source of valid information,” dispensing data of “clinical and medical value.”
The conflict-of-interest policy that the authors prefer is the code of the American College of Physicians (ACP). It recognizes the power of gifts to influence prescribing but leaves the ultimate decision about whether to accept them to the discretion of the physician. The authors' preference reflects their primary goal — to determine whether a given behavior is lawful or likely to capture the attention of regulators and prosecutors. From this vantage point, they see no need for an absolute ban on gifts when so many physicians accept them, making this behavior a standard of practice. They also point out that several medical societies do not ban gifts and that regulators tolerate gifts that are “modest” (though little guidance is provided on which gifts qualify as modest) and do not seem to carry an overt quid pro quo. According to the authors, if the ACP standards are met, the legal risk is “remote” and physicians — at least those who are not especially risk-averse — need not worry. In short, the behavior is acceptable as long as physicians will not face prosecution.
The discussion of physicians' participation in speakers' bureaus follows an identical pattern. The authors observe that participating in these activities has “come under fire.” The ABIM–IMAP task force recommended that physicians not serve as members because speakers' bureaus are essentially marketing activities that turn medical professionals into company salesmen. But the authors note that no formal codes ban such activity and that the number of such presentations nearly tripled between 1998 and 2006. Thus, physicians should make certain that the company slides are accurate and that the level of compensation represents “fair market payment.” Once again, however, the law, and not a standard of professionalism, shapes the advice.
The authors conclude by urging organizations to design and enforce compliance plans and to train members to avoid legal liability. Everyone should make certain, to use regulatory language, that physicians remain within “safe harbors.” Are such strategies sufficient to address the problem of conflict of interest? Probably not. There is too much writing on the wall in the form of new initiatives from government, industry, and academic medical centers that promote not only disclosure but also transparency. There are also legislative efforts at both state and federal levels that are designed to curtail the largesse of industry. In the final analysis, the manual's overarching goal is to help physicians figure out how to comply with present statutes — not how to get ahead of the curve. Had its authors given more weight to the principles of professionalism instead of to regulations, they might have made a more noteworthy contribution.
David J. Rothman, Ph.D.
Columbia University College of Physicians and Surgeons, New York, NY 10032
djr5@columbia.edu - Citing Articles (1)
Citing Articles
1
J J Gagne, A R Patrick, H Mogun, D H Solomon. (2011) Antidepressants and Fracture Risk in Older Adults: A Comparative Safety Analysis. Clinical Pharmacology & Therapeutics 89:6, 880-887
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