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The politics of ethics, profits
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CHICAGO — The American Medical Association (AMA) has decided that it is OK for physicians to sell nutritional supplements from their offices, but it is not OK to make a profit. Its Council of Delegates recently approved a set of ethical guidelines in an attempt to regulate the practice. The guidelines from the Council on Ethical and Judicial Affairs (CEJA) were a diluted version of the council’s earlier virtual ban on the practice, which had been rejected by the Board of Delegates the previous year. The new guidelines passed the Board with only six votes.
CJEA leaders said it sought a “reasoned response” to a controversial issue. Even without an absolute ban, they say the guidelines will help protect patients and maintain physicians’ professionalism. “On the surface, some may say this is about restraining physicians’ private practices or restricting patients’ access to services. But, actually, the core issue here is preventing the potential exploitation of patients,” said former CEJA Chair Robert M. Tenery Jr., MD, in an AMA press release. “When patients think of their doctors as entrepreneurs, that’s when trust is jeopardized.”
AMA sets limits
For those physicians who override the AMA’s discouragement, the guidelines outline several limits. Among them: they should validate claims of the products’ medical efficacy and not rely on manufacturers’ potentially biased data; they should not participate in exclusive distributorships in which products are available only through the doctors’ offices; they should instead encourage manufacturers to make products more widely available; and they must fully disclose to patients their financial arrangement with the manufacturer or supplier and the availability of a similar product elsewhere.
R. Scot Hunter, president and chief executive officer of ScienceBased Health (Corte Madera, Calif.), manufacturer and distributor of nutritional supplements sold solely by physicians in the office, said he was initially concerned about the potential effect of the AMA’s guidelines. “It turned out there was no detectable effect at all,” Mr. Hunter said. “For the most part, what our customers and our medical advisers told us was that, ‘the AMA does not speak for me.’ With all due respect to the AMA, our research shows that large numbers of patients prefer to take specialized nutritional supplements under a physician’s supervision, and that physicians are eager to extend assistance to patients by providing our clinically researched, indication-specific formulas. Physicians should be encouraged to become actively involved in nutritional medicine in light of the alarming number of reported medical incidents experienced by self-dosing patients. The positions of the American College of Physicians and the American Society of Internal Medicine make more sense. ScienceBased Health clearly demonstrates the principles of ‘nonmalfeasance’ and ‘beneficence’ in both our disclosure policies and in our insistence on formulating our products based on the latest and most well-documented medical research. And, for those wishing to avoid making a ‘profit,’ on these formulations, we always give our physicians the option of distributing their proceeds to the non-profit foundation of their choice.”
A powerful position
The American College of Physicians and the American Society of Internal Medicine also has taken a position on the practice of physicians selling products out of their offices. In a 1999 position paper, published in the Annals of Internal Medicine, the groups stated: “Physicians occupy a powerful position with respect to patients. Special knowledge, social authority and the power to make available or withhold access to other medical care all give the physician a disproportionate advantage over patients. Products sold out of the office carry the imprimatur of this authority; patients may believe that physicians specifically endorse these products ... The decision to make products available through office sales is complex. Physicians’ fiduciary responsibility requires that such decisions adhere to two fundamental ethical principles: nonmaleficence and beneficence. Clearly, the principle of nonmaleficence prohibits the physician from selling products that pose a threat to patient safety, are not essential to the patient’s care or may interact negatively with other therapy … By adhering to the duties of nonmaleficence and beneficence; by applying the criteria of urgent need, clinical relevance to patients’ conditions, adequate evidence-based data to support clinical use of the item and constraints on patients’ time or geographic access to a product; and by disclosing financial interests and encouraging patients to explore alternatives where appropriate, physicians may maintain high ethical standards while affording patients access to products essential to their care.”
For Your Information:
- Robert M. Tenery Jr., MD, can be reached at 2777 Forest Lane, Ste. B424, Dallas, TX 75230; (972) 566-8200; fax: (972) 233-0129. Dr. Tenery has no direct financial interest in any of the products mentioned in this article nor is he a paid consultant for any companies mentioned.
- R. Scot Hunter can be reached at ScienceBased Health, 300 Tamal Plaza, Ste. 220, Corte Madera, CA 94925; (888) 433-4726; fax: (415) 927-0990; Web site: www.ScienceBasedHealth.com. Mr. Hunter is president and chief executive officer of ScienceBased Health.