Study: Scientifically Unproven Marketing Claims Very Common on Websites

Medical Ethics Advisor Logo

Michael H Cohen has been interviewed by the Medical Ethics Advisor, a well established publication that focuses on current healthcare issues.

Here are some of the comments made by Michael H Cohen:

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 unethi-cal,” 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.

For the full article, click here

Book your Legal Strategy Session now
Michael H Cohen Healthcare & FDA Lawyers

Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.

Related Posts

Start typing and press Enter to search