EXECUTIVE SUMMARY

Marketing claims on websites of complementary and alternative medicine (CAM) therapies practitioners regarding allergy and asthma often included interventions that were not scientifically supported, according to a new study. Some ethical concerns:

  • Most of the advertised treatments lacked evidence of efficacy.
  • People may be making important treatment decisions based on unreliable information.
  • Clinicians have the same informed consent obligations whether they are providing conventional or CAM therapies.

A significant percentage of the public seeks health advice from complementary and alternative medicine (CAM) practitioners. “People may be relying on this information to make important treatment decisions,” says Timothy Caulfield, LLM, FRSC, FCAHS, one of the study’s authors and research director at University of Alberta’s Health Law Institute in Canada.

Much of this advice relates to allergies and asthma. “We thought it important to get a sense about what is being offered,” says Caulfield. Researchers analyzed marketing claims made on 392 websites by Canadian chiropractors, naturopaths, homeopaths, and acupuncturists relating to the diagnosis and treatment of allergy and asthma.1

Naturopath clinic websites have the highest rates of advertising at least one diagnosis, treatment, or efficacy for allergy or sensitivity (85%) and asthma (64%), followed by acupuncturists (68% and 53%, respectively), homeopaths (60% and 54%), and chiropractors (33% and 38%).

Of the interventions advertised, few are scientifically supported. The majority lack evidence of efficacy, and some are potentially harmful, found the researchers.

“While we knew that CAM providers were working in the areas of allergy and asthma, we were surprised how common it was to mention treatments,” says Caulfield.

Eighty-five percent of naturopaths, for example, advertised a diagnostic procedure or treatment, or commented on the efficacy of these approaches. “Given the lack of evidence to support these practices, this is a worrisome trend,” says Caulfield.

Caulfield believes regulators should monitor the use of misleading health claims. “These claims appeared on the websites of individuals and clinics holding themselves out as healthcare professionals,” he says. “I think we can all agree that the public should have access to reliable health information.”

Clinicians have the same informed consent obligations whether they are providing conventional or CAM therapies, says Michael H. Cohen, JD, a Silicon Valley, CA-based attorney specializing in healthcare legal and regulatory issues, especially involving CAM and integrative medicine. Cohen is a former assistant professor of medicine at Harvard Medical School.

This means discussing the potential risks, benefits, and alternatives of a given therapy. Many therapies carry some risk of harm, whether conventional or CAM. “This does not mean they are inherently unethical,” says Cohen. “It does mean that providers must take the time to have clear discussions with patients, and document that these conversations have occurred.”

Failure to provide adequate informed consent generally is considered unethical, adds Cohen, and can be grounds for a malpractice action. Additionally, when physicians create their own line of products, going beyond clinical recommendations to their patients, such physicians can face enforcement actions from the FDA and the Federal Trade Commission (FTC). While the FDA generally does not intrude on the practice of medicine, says Cohen, “it does have jurisdiction over products in interstate commerce, and this is interpreted broadly.”

FDA and FTC require that manufacturers and distributors of healthcare products substantiate their claims through “competent and reliable scientific evidence,” explains Cohen.

“Beneficence includes recommending therapies of potential benefit whether they are in the conventional or ‘CAM’ domain,” Cohen adds. The physician has an ethical duty not only to do no harm, but also to actively promote the patient’s well-being. “The best way to do this is through an open mind that reviews the literature, listens compassionately and sensitively to the patient, and takes into account the panoply of therapeutic options, with the patient actively engaged in decision-making,” says Cohen.

Intent Is Relevant

Geraldine M. Jacobson, MD, MPH, MBA, chair and professor in the department of radiation oncology at West Virginia University School of Medicine in Morgantown, points out that chiropractors, naturopaths, homeopaths, and acupuncturists all are represented by professional associations which have codes of ethics.

“Common themes in these codes of ethics are to focus on the care of the patient and not to take advantage of the patient for personal or financial gain,” says Jacobson.

When a health practitioner recommends a treatment, the principle of autonomy, which includes informed choice of treatment, dictates that the practitioner should be honest about the potential benefits and harms, says Jacobson.

“If the practitioner is aware that there is no scientific basis to the recommended treatment, that information should be shared with the patient,” she says. Jacobson says the following are unethical practices:

  • if the practitioner promotes a treatment solely for financial gain without the expectation of benefit to the patient;
  • if a practitioner is promoting a treatment that he or she knows is potentially harmful, and does not share this information with the patient.

When recommending treatments that are not scientifically supported, the practitioner’s intent matters, says Jacobson. If the practitioner has experience with a treatment, has found it beneficial, and has not been informed of harmful effects, it may be ethical to recommend the treatment, if the intention is to benefit the patient.

“Not all alternative forms of treatment have been scientifically tested,” notes Jacobson. For example, acupuncture has now been shown to be effective for multiple conditions, but has been practiced for centuries without being subject to scientific investigation. Jacobson says this approach is best: “In a situation where there is lack of supporting data for a treatment, but practical experience suggests benefit, this information should be truthfully shared with the patient.”

REFERENCE

  1. Murdoch B, Carr S, Caulfield T. Selling falsehoods? A cross-sectional study of Canadian naturopathy, homeopathy, chiropractic and acupuncture clinic website claims relating to allergy and asthma. BMJ Open 2016; 16;6(12):e014028.

SOURCES

  • Timothy Caulfield, LLM, FRSC, FCAHS, Trudeau Fellow and Professor, Faculty of Law and School of Public Health/Research Director, Health Law Institute, University of Alberta, Canada. Phone: (780) 492-8358. Email: caulfield@ualberta.ca.
  • Michael H. Cohen, JD, Michael H. Cohen Law Group, Palo Alto, CA. Phone: (310) 844-3173. Web: www.michaelhcohen.com.
  • Geraldine M. Jacobson, MD, MPH, MBA, Chair/Professor, Department of Radiation Oncology, West Virginia University School of Medicine, Morgantown. Phone: (304)-293-7227. Email: gmjacobson@hsc.wvu.edu.