CAMLAW: Complementary and Alternative Medicine Law Blog

Advising Patients Regarding Dietary Supplements

Clinicians often ask: "How do I advise patients when evidence concerning dietary supplements is non-existent or conflicting?" And: "Does selling supplements in my office create an ethical conflict?" Here's an approach to tackling these questions.

First, in advising patients regarding any complementary and alternative medical (CAM) therapy, consider four possible categories of therapies, namely, those where the evidence: (A) supports both safety and efficacy; (B) supports safety, but evidence regarding efficacy is inconclusive; (C) supports efficacy, but evidence regarding safety is inconclusive; (D) or indicates either serious risk or inefficacy. This strategy should apply to therapies across the board, whether "conventional" or "CAM," "herbal," pharmaceutical, or "nutraceutical."

In Region (A), the clinician probably will feel comfortable recommending the therapy. On the other hand, in region (D), the clinician should avoid and actively discourage; and in (B) and (C), the clinician should caution the patient regarding concerns about effectiveness and safety respectively, and in any event, continue to monitor conventionally for effectiveness and safety. Cohen MH, Eisenberg DM. Potential physician malpractice liability associated with complementary/integrative medical therapies. Ann Intern Med; 2002;136:596-603.

The law defines malpractice (or negligence) as: (1) providing services below the standard of care for the profession, and (2) thereby injuring the patient. To the extent the clinicians offers a therapy that has serious safety and/or efficacy concerns (i.e., region D), both elements of the tort are likely to be satisfied, meaning that malpractice liability is highly likely. Most therapies, however, tend to fall in regions B and C, where evidence is mixed; one cannot make a ready prediction of liability, particularly in these regions, but obviously the riskier the therapy and the less evidence supporting its use, the more likely both elements of the tort will be met; hence caution and continued conventional monitoring are critical. (Id.)

Under this analysis, if evidence concerning dietary supplements is non-existent, the therapy probably falls within region (D) - and liability is likely to follow. On the other hand, if evidence is mixed, one may be in either region (B) or (C).

Evidence changes over time, so a therapy can shift from category to category. And liability risk management by and large dovetails with clinical good sense: when a patient is using therapies in regions (B) and (C), the clinician should monitor and stand ready to intervene conventionally if the therapy produces direct toxicity, fails, or creates adverse interactions with conventional therapies (e.g., herb-herb; herb-drug). This "caution and monitor" strategy should help minimize risk of patient injury as well as lawsuits.

As to selling supplements in the office, the American Medical Association's Policy E-8.063 (Sale of Health-Related Products from Physicians' Offices)unambiguously provides: "In-office sale of health-related products by physicians presents a financial conflict of interest, risks placing undue pressure on the patient, and threatens to erode patient trust and undermine the primary obligation of physicians to serve the interests of their patients before their own."

The policy goes on to state: "(1)Physicians who choose to sell health-related products from their offices should not sell any health-related products whose claims of benefit lack scientific validity. When judging the efficacy of a product, physicians should rely on peer-reviewed literature and other unbiased scientific sources that review evidence in a sound, systematic, and reliable fashion." The clinician can spin out how most dietary supplements would fare under this language. Under the Dietary Supplement Health Education Act of 1994 (DSHEA), manufacturers can make "structure-function" and other claims without the same level of scientific substantiation and validity as, say, claims for prescription drugs.

The policy further provides that: "(2) Because of the risk of patient exploitation and the potential to demean the profession of medicine, physicians who choose to sell health-related products from their offices must take steps to minimize their financial conflicts of interest." The enumerated steps include: (a) limiting sales to "products that serve the immediate and pressing needs of their patients;" (b) providing products to their patients "free of charge or at cost;" (c) disclosing "fully" their financial arrangement with a manufacturer or supplier to sell such products; and (d)avoiding "exclusive distributorships of health-related products which are available only through physicians' offices."

Here is what the Ethics and Human Rights Committee of the American College of Physicians has said on this issue: "The sale of products from the physician's office raises several ethical issues and may affect the trust necessary to sustain the patient-physician relationship. When deciding whether to sell products out of the office and, if so, which ones, physicians should carefully consider such criteria as the urgency of the patient's need, the clinical relevance to the patient's condition, the adequacy of evidence to support use of the product, and geographic and time constraints for the patient in otherwise obtaining the product. Physicians should make full disclosure about their financial interests in selling the product and inform patients about alternatives for purchasing the product. Charges for products sold through the office should be limited to the reasonable costs incurred in making them available." Povar GJ and Snyder L. Selling Products Out of the Office, Ann Int Med 1999;131:11:863-864 (excerpted on the Bioethics Discussion Blog).

But there are two additional risks beyond the ethical question. The first is that many states regulate clinician sales of dietary supplements. Some states prohibit the practice, while others require disclosure of the clinician's financial interest in the supplements, and still others allow the pracice only with appropriate disclosure and a state-mandated limitation on percentage profits. The second risk is that in a malpractice case, the jury may view selling supplements as enhancing the defendant clinician's culpability. This in fact happened in Charell v. Gonzales, during which the jury viewed the physician's sale of supplements as greedy and therefore constituting recklessness, rather than negligence. (Plaintiffs can get punitive damages for recklessness, whereas they can only receive compensatory damages for negligence).

In short, selling dietary supplements within the office is legally as well as ethically risky.

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Michael H. Cohen, Esq.; 468 North Camden Dr. | Beverly Hills, California 90210 | 310-844-3173