| Samples of quotes provided by Michael H. Cohen to the mainstream and academic press “Ethical analysis of CAM and the discussion of informed consent in particular are in their infancy...I don't think an extended theological debate is a prerequisite to any attempt to deliver care that goes beyond the boundary of historically understood medical services. Reasonable patients arguably would want to identify aspects that conflict with their belief systems and withdraw if they so wish.” “It's time for the law to expand beyond the narrow focus of biomedicine and embrace the more inclusive holistic model of healing. ... [I would] like to see a duty to refer run both ways between medical physicians and alternative providers.” |
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“Some people are proceeding cautiously. But alternative medicine is a huge industry, and there a lot of people wanting a piece of the pie.” Michael Cohen, Assistant Professor of Health Law and Policy at the Harvard School of Public Health and co-author of this article about CAM credentials, told me yesterday that “The world is basically divided into two groups: MDs and Everyone Else.” The latter category, he explained, includes allied health professionals -- such as occupational therapists and physical therapists -- and CAM practitioners. The realm of CAM is further divided between licensed and unlicensed practitioners. Checking a licensed CAM practitioner's credentials and performance is similar to checking an MD's, Cohen says. Your state regulatory board, like a state medical board, likely has a Web site on which you can look up a practitioner's name to see whether he has an active license and whether disciplinary action's been taken against him. Some will include a database listing malpractice claims, too. [The controversial Dietary Supplements Health Education Act of 1994] “signaled Congressional recognition that there is a whole other branch of healing....It made it safe to talk about complementary and alternative medicine for the first time.” “Arguments over licensing will only get louder as alternative medicine grows more popular”... “Protectionism is the dark side of quality control. The debate is over whether we want and need this. Does it protect the public?” “The health care system that we know today evolved out of a specific historical, social, political and economic context. At the end of the 19th century, we had rival groups of health care providers competing for authority and preeminence. We did not have the widespread licensure of chiropractors, acupuncturists, massage therapists, naturopaths and others that we have today. We had a health care system in which one particular branch of health care, scientific medicine--for which I have a great deal of respect, and which obviously is very useful and engaging--came to dominate the system. My argument is that as we move into the next century, we're going to start seeing a greater parity between different providers as points of entry into the health care system. If someone has a health issue, it's not going to be seen primarily or exclusively as something to be treated on a surgical or pharmaceutical level. It could be seen as the result of many different factors, some of which might be physiological, emotional, mental or spiritual, and we're going to see different kinds of interventions coming to the fore. What we've previously called 'alternative' will be seen as having greater utility. My prediction is based not only on the increased scientific evidence, but also consumer interest, regulatory interest, and just the way the culture as a whole is moving.” Michael clarified that he was “really looking far into the future” and that parity “depends on the extent to which the culture grants more equal respect to nonmedical providers. One has to put a disclaimer on these forward-thinking proposals, because MDs do have a particular domain. Obviously, when you need surgery, you need surgery; you don't need an acupuncturist when you have to go to the emergency room. What this is really getting at is the idea of greater parity between different providers, and a greater mutual respect and appreciation for what each one can and cannot do. If someone will benefit from manipulation for low back pain rather than surgery, there should be a duty to refer the patient for that kind of treatment.” “I see a trend toward greater respect, greater tolerance and mutual cooperation. I see a team approach with referrals back and forth, but not a duty to refer that is a fear-based model of coercion based on adverse legal consequences. What I would like to see is a model based on appreciation, respect, knowledge, wisdom and caring for the patient; where there's greater team involvement in patient care; where each kind of practitioner understands the breadth of the others' knowledge and the limitations of their own discipline; and where they need to reach out and have a common enterprise. The opposing trend, which is also a possibility for humanity and the health care system, is the trend that has dominated health care since its inception in the U.S. That trend is turf battles, waging war, trying to narrow the scope of authority of others, monopolization--that's what we have seen so far. Which path the professions want to take is up to the leaders in the field, but both are possibilities, and they may go on simultaneously.” “The battle that chiropractors face really exists in the larger context of what kind of health care system we are going to choose in this country: whether we're going to have truly integrative medicine and health care, or a system in which providers and the law carve the patient into a series of different parts. That's the way it works now, and that's the way a lot of people think about patient care. The massage therapists get the muscles; the psychologists get the emotions; the chiropractors get the spine; the dermatologists get the skin; and so on and so forth, and this approach really does not lead to the cure for the whole being, which is my sense of the holistic enterprise. Whether it's chiropractic or medicine, isn't the goal really the same? Isn't it really about helping people?” “The low national rates [for malpractice lawsuits] may stem from the differing standards of care and the more complex relationship between provider and patient.” ...“The law will follow the medical community in many of these cases. The courts across the country opening up a bit to embrace the new model [of integrative and alternative care].” ...“Insurers generally have not reimbursed alternative medical care because they could legally exclude alternative medicine as 'not medically necessary. However, effective alternative medical treatments should be acceptable whether or not the treatment falls within the paradigm or involves drugs or surgery.” ...“With all forms of alternative and conventional medicine, we must come together to understand that we want the best of drugs and the best of natural medicine.” “The Navarro Act [H.R. 3677],” he noted, “marks a significant shift in regulatory thinking about patient access to therapies not approved as safe and effective by the FDA. It signals a change from paternalism at any cost, to respecting autonomous, informed patient choice. This legislation takes what the FDA has established in regulations and codified, with one significant change: it puts the final decision into the hands of the patient.... The legislation could have a trickle-down effect on other areas of law, such as state licensing of health care providers, scope of practice rules, insurance reimbursement practices, malpractice liability and professional discipline arising out of use of complementary and alternative medicine. By giving power back to the patients, without putting the bureaucracy out of the process, the legislation could make state legislatures, medical boards, and courts view deviations from conventional care with a less skeptical eye if accompanied by informed patient choice.... There are several key differences between the Navarro Act and the Access to Medical Treatment Act. The Navarro Act targets clinical holds on investigational new drugs and conditions imposed by the FDA for expanded access to such drugs. [It] only deals with a patient seeking a drug under clinical investigation in a clinical trial. The Access Act grants patients access to any treatment that is not approved by the FDA, that is offered by any health care provider within his or her legislatively authorized scope of practice.... The Access Act is broader, the Navarro Act targeted. The Navarro Act only requires that the patient be 'aware of the risk involved in receiving the investigational new drug, and chooses to receive the drug notwithstanding such risk and notwithstanding the comparable or satisfactory alternative therapy.' Patient protection already is built in to the regulatory process involving investigational new drugs. The Access Act requires, among other things, that: (1) there is 'no reasonable basis to conclude that the treatment itself, when used as directed, poses an unreasonable and significant danger to such individual'; (2) the provider notifies the patient in writing of the nature of the treatment, including, among other things, 'reasonably foreseeable side effects.' ... The bottom-line: the patient protection provisions of the Access Act are more explicit but both pieces of legislation emphasize patient choice of access to the therapy.” “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). “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.” |
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