More Media Clips
Arguments over licensing will only get louder as alternative medicine grows more popular, Michael H. Cohen told the Independent Weekly in "Licensing Battle Brewing Over Alternative Medicine."
"Michael Cohen, assistant professor of medicine and director of legal programs at Harvard Medical School. Cohen, who has written about credentialing efforts in other states and has a blog on the issue (www.camlawblog.com) says licensing proposals have led to 'deep philosophical debates' about whether alternative medicine should be regulated the way conventional medicine has been for a century or more.
"Protectionism is the dark side of quality control, Cohen says. The debate is over whether we want and need this. Does it protect the public?"
The article (1/26/06) described efforts to achieve licensure for naturopathic doctors in North Carolina--as well as efforts by lay naturopaths to derail such legislation. According to Barbara Solow's article, in North Carolina, "massage therapists, acupuncturists and chiropractors are currently the only non-traditional healers who are recognized by law....The state Medical Society has been one major roadblock to licensing. Many doctors are reluctant to grant naturopaths--who focus on preventing disease through diet, exercise, biofeedback and herbal remedies--an official stamp of approval. But an equally serious challenge is coming from within--from naturopaths and other alternative practitioners who see licensing as a threat to their livelihoods."
[For the record: as explained in Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives, title licensure is one viable option for mediating the interests of both sides. This was raised in the interview, though the short quotation without further context leaves ambiguous who might be considered 'protectionist' and what might best 'protect the public.']
Michael H. Cohen was interviewed in August 2005 by Applied Neurology on the topic of why it is important for all physicians (and neurologists in particular) to be aware and informed about complementary and alternative medicine from a legal perspective.
To quote from the article, available at www.appeurology.com:
"The field is growing and interest is growing," said Michael H. Cohen, JD, MBA, assistant [clinical] professor of medicine at Harvard Medical School, a principal in his own law firm, and author of [4] books on the legal implications of CAM.
"The fact that there are now 29 academic medical centers with integrative medicine programs tells you that this is an expanding phenomenon and that there are credible people in legitimate medical centers," he continued. "Even the diehards who still say this is all bunk are being forced to confront these issues, because if patients are using these therapies, then a responsible clinician has to know how to converse intelligently, dispassionately, neutrally, and in a way that is mindful of legal and ethical obligations."
In terms of practical guidance for the clinician, a starting point, according to Cohen, is the test for informed consent in conventional medicine: would a reasonable patient, in a similar situation, find the information regarding the complementary and alternative therapy to be material to the decision to use or forgo that therapy?
"My position has been that the same principles from health law that apply to conventional medicine can be applied across the board--whether you label a therapy conventional or complementary," said Cohen. "So the obligation of informed consent is the obligation to disclose and discuss with patients all material treatment possibilities."
What if a physician doesn't know about the alternatives? "Ignorance is no excuse," Cohen said. "To disclose and discuss all material treatment alternatives--now what's material? States interpret that differently. Some states say 'material' is what a reasonable MD in that position would consider significant, and half of the states say that it is what a reasonable patient would consider significant."
Is there room for argument? "There's room for argument on what is a reasonable physician," Cohen responded. "Certainly, if your patient is taking an herb or dietary supplement and you do not inquire about it, I would say there is arguable failure to do due diligence there. The ostrich approach is probably not to be recommended," he said.
The Whole Child: An Integrative Pediatrics Forum Hosted by Dr. Larry Rosen described the case of Abraham Cherrix, a 16 year-old with Hodgkin's disease who has been refusing further conventional cancer treatment and would like to solely pursue the controversial alternative Hoxsey method. "Legal CAM expert Michael Cohen, author of the CAMLAW blog, offers guidelines in several landmark publications. The most recent, "Legal and Ethical Issues Relating to Use of Complementary Therapies in Pediatric Hematology/Oncology" (March 2006), helps us frame the discussion around standard ethical principles like nonmaleficence (do no harm), beneficence (do good), and autonomy (the patient's right to choose treatment or not treatment). But, as Cohen points out, "...the choice to include CAM therapies is richer than a black-and-white decision between ethical / unethical." He discusses the 2005 Institute of Medicine report on CAM therapies, noting several factors which may help clinicians decide when CAM use is appropriate; these include severity and acuteness of illness, curability with conventional treatment, invasiveness and side-effects of conventional treatment, and quality of evidence of safety and efficacy of the CAM treatment. In Abraham's case, all of these factors are up for debate....Interestingly though, the legal battle in this case does not seem to be centering on which alternative therapy he chooses, but mainly on Abraham's right to choose for himself his course of action." (July 19, 2006).
Featured in The Integrator Blog's piece on Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration:
"The guidance reads more like an assertion of potential FDA jurisdiction than an actual guide to industry conduct. And consistent with its history, the FDA is asserting as broad a potential jurisdictional reach as possible."Some of this may be motivated by ‘homeland security’ concerns (see, for example, the discussion of biological products). Some may simply be agency expansionism. Some may simply reflect the paternalistic stance of being too controlling in trying to protect consumers from bad outcomes. And some may simply be an attempt to clarify a confusing regulatory landscape.
"I would encourage the agency to be ever more mindful of the balance between consumer protection (regulate where you can) and consumer freedom (abstain from regulating except to require sufficient disclosure as to facilitate informed consumer choices). And I think it would be healthy for the FDA to actually articulate this balance.
"In drawing the balance more accurately, one place where we still need an injection of creative thinking is the confusing borderland between supplements and drugs. For example, prohibited disease claims mysteriously convert a 'supplement' into a 'drug.' I think it might have been Stephen DeFelice, MD who coined the apt term, 'epistemological chaos.' A substance is what it is regardless of the claim.
"There has to be a more intelligent way to regulate manufacturer labeling, perhaps by tying allowed language to existing clinical data, or simply drilling down more into the notion of what is false and misleading. And, state licensing laws and scope of practice rules can take up the slack in dealing with practitioners who make overbroad claims.
"In general, and particularly in the age of the Internet, the whole regulatory structure needs to give more credit to consumers’ ability to make wise choices concerning what goes into their bodies. That stance, as opposed to asserting the long arm of jurisdiction, will help the FDA increase its legitimacy and credibility while providing a negotiated buy-in for manufacturers, practitioners and patients."
Read earlier Media Clips.
