Informed Consent and CAM

Source: Ernst E, et al. Informed consent in complementary and alternative medicine Arch Intern Med 2001:161:2288-2292.

The increasing popularity of complementary and alternative medicine (CAM) poses serious challenges for the physician, not the least being the issue of informed consent. Informed consent should include adequate information about the risks and benefits of all treatment options. The information about potential risks, including frequent, non-serious adverse affects and infrequent, serious complications, is crucial for patients to know. Failure to disclose the availability, benefits, and risks of CAM treatments could give rise to malpractice claims. The ethical rules physicians follow in conventional care usually can be applied to treatment with CAM. The focus must be on expressing risks clearly, documenting informed consent adequately, and keeping up-to-date with the emerging evidence on CAM.

As CAM becomes accepted by and integrated into mainstream health care, it will pose a number of serious problems for the physician. One formidable challenge is to formulate and adhere to ethical standards for CAM that compare favorably with those of conventional medicine. Ethical standards, in turn, are a precondition for physicians and other health care providers to assess whether and when to refer patients to CAM practitioners. This review discusses one particular ethical issue, informed consent, which clinicians are called on to provide on a daily basis. Moreover, there are prominent legal implications.

Comment

Informed consent is comprised of three elements: adequate information, reasonable understanding, and non- coercion. It is a basic principle in both law and medicine, and most physicians respect it deeply. Whether one should obtain informed consent for CAM is a thorny, multifaceted problem that already has attracted book-length manuscripts and formal analysis.

The clinical analysis is simpler: Patients are, of their own volition, seeking out non-medical practitioners and practices that are outside the mainstream of medical practice, and often paying for it out of pocket. The medical principle of informed consent often is not in play, as a health care entity is uninvolved. Other principles govern this interaction, e.g., the integrity of business and the "caveat emptor" of the marketplace.

When mainstream physicians offer CAM therapy as therapy, however, they incur the ethical obligations associated with prescription pharmaceuticals, surgical intervention, and other, more standard treatments. Unfortunately, a great deal of the information about many CAM therapies is either unavailable to prescribing physicians or of unacceptable quality. The patient or her surrogate may reasonably understand what information is provided, and may not feel forced to accept the physician’s recommendation. But how much information is adequate, especially about risks and benefits, often is where the rub arises.

The authors present three legal cases concerning CAM and clinical practice. In one, hair analysis was used for cancer diagnosis; in another, nutritional therapies were used in breast cancer treatment after a permission/waiver was signed; and in a third, a patient sued because a physician did not disclose EDTA chelation as an alternative treatment for carotid endarterectomy (the physician was acquitted). Although two of these cases reached the appellate level, the authors appropriately note that case law is sparse and underdeveloped.

The authors attempt to fashion an approach to informed consent in CAM, based on the cases above, and their knowledge of CAM and the legal process. They favor disclosure of available CAM therapies that patients may want. They note that "physicians and patients often disagree on what kind and what level of evidence make a therapy demonstrably safe and effective enough for the physician to tolerate or re- commend the therapy." The latter point is highly contentious: It is one thing to accommodate a patient’s use of CAM; it is another thing altogether to pre- scribe it.

Recommendation

Physicians should attempt to apply ordinary principles of informed consent when recommending a CAM therapy, and should attempt to recommend CAM therapies that are strongly evidence-based. I know of no affirmative obligation to disclose CAM therapies that patients may want but for which the physician cannot reasonably be expected to know the evidence.