“Ethical analysis of CAM and the discussion of informed consent in particular are in their infancy,” Michael told Science & Spirit in “Spiritual Side Effects” (July-August 2002).
“Michael Cohen, director of legal programs at Harvard Medical School’s Division for Research and Education in Complementary and Integrative Medical Therapies, [says that] good physicians must respect the personal, cultural, and religious dimensions of each patient … but they must not overestimate potential religious conflicts, particularly for therapies delivered in a secular manner. ‘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’, he says. ‘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,” Michael told Medical Economics in an interview about medical liability for inclusion of complementary and alternative medical therapies (9/24/99). Michael also told Medical Economics that he would “like to see a duty to refer run both ways between medical physicians and alternative providers.”
“The health care system that we know today evolved out of a specific historical, social, political and economic context,” Michael told Dynamic Chiropractic in Whither Goes Alternative Care (7/12/99). “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.”
Michael added: “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.”
Michael observed: “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?”
“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 told the Los Angeles Times in “Alternative, Conventional Care Forge Uneasy Alliance” (9/2/98). And in “Hope or Hype?”, Michael told the Los Angeles Times that the controversial Dietary Supplements Health Education Act of 1994 (the DSHEA) “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.”
“The low national rates” for malpractice lawsuits “may stem from the differing standards of care and the more complex relationship between provider and patient,” Michael told the Business Report on Complementary and Alternative Medicine in “Legal Issues Are Arising As Alternative Medicine Evolves.” “The law will follow the medical community in many of these cases,” Michael said, going on to analyze the way judges might apply legal doctrines such as the ‘respectable minority defense’ and assumption of risk. “The courts across the country opening up a bit to embrace the new model [of integrative and alternative care,” he added.
On the subject of third-party reimbursement, Michael noted: “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.”
Michael concluded: “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.”
Michael also spoke with Alternative Medicine Business News about “Costs and Benefits of Credentialing Alternative Providers” (May 1999), Nutrition in Complementary Care about “Dietary Supplementation: The Newest Specialty” (Fall 1999), Physicians’ Financial News about “Liability Risks in Alternative Medicine” (October 15,1999), Natural Healthline for its story on “Thomas Navarro Medical Freedom Update: Family is Optimistic” (March 1, 2000), and the Houston Chronicle for its story, “Cancer Treatment For Boy, 4, Sought From Burzynski” (Feb. 16, 2000).
“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.”
Michael gave radio interviews on Gary Null’s Natural Living (“Legal Boundaries of Alternative Medicine,” 2/4/99); Orange County Now (“Alternative Medicine,” 12/99); Here’s To Your Health with Deborah Ray and Ronald Carrow, M.D. (“Complementary Care,” 3/88, 9/88; “Children’s Rights,” 2/99; “Informed Consent,” 6/99); and Beyond Wellness (Palm Springs, 6/98).
Michael was interviewed on Discovery Health Channel (“Examining the Alternatives,” 12/99); Total Health Talk (LA cable, 3/98); The Alternative Medicine Show (D.C. cable, 6/98); and The American Health Network (6/98).
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