In April the Federation of State Medical Boards of the United States (FSMB) adopted as policy "Model Guidelines for the Use of Complementary and Alternative Therapies in Medical Practice" for state medical boards to use in educating and regulating (1) physicians who use CAM in their practices, and/or (2) those who co-manage patients with licensed or otherwise state-regulated CAM providers."
While the guidelines were under development, FSMB invited input from NCAHF Board members Tim Gorski, MD and Wallace I. Sampson, MD. The final document included some statements they suggested, but it ignored their important recommendation to not recognize "CAM" as if it is a second kind of medicine. Thus, FSMB's guidelines document describes complementary and alternative therapies in medical practice (CAM) as "a fluid concept defined differently by various organizations and groups" and distinguishes it from "conventional medicine." As a definition of CAM, FSMB used a description provided by the National Center for Complementary and Alternative Medicine (http://nccam.nih.gov). This description fails to express CAM as a meaningful concept. It also neglects to point out that CAM is marketing doublespeak that gives the appearance of legitimacy to a wide range of nonvalidated and invalidated approaches to healthcare.
The FSMB guidelines document recognizes that healthcare practices can cause patients economic harm, indirect harm from delay of appropriate treatment, and direct harm. FSMB suggests as criteria for considering whether a physician is practicing appropriate medicine, four categories of treatment: (1) effective and safe, (2) effective, but with some real or potential danger, (3) inadequately studied, but safe, or (4) ineffective and dangerous.
The FSMB proposed seven model guidelines: (1) Evaluation of Patient, (2) Treatment Plan, (3) Consultation and/or Referral to Licensed or Otherwise State-Regulated Health Care Practitioners, (4) Documentation of Medical Records, (5) Education, (6) Sale of Goods from Physicians Offices, (7) Clinical Investigations. The guidelines give consideration to risks to patients, comfort of patients, expectations of benefits, standards of safety and reliability, informed consent, other ethical responsibilities, accuracy and completeness of documentation, responsibility, medical scientific knowledge of physicians, and potential for patient exploitation. The complete document is posted online at www.fsmb.org.
Dean Ornish, MD is the president and director of the Preventive Medicine Research Institute, Sausalito, California and author of five best-selling books. He served on the White House Commission for Complementary and Alternative Medicine Policy (WHCCAMP) which issued recommendations to the President that NCAHF has criticized in a position paper issued March 25th (www.ncahf.org/pp/whcpp.html). Former NCAHF President William M. London, EdD, MPH, who testified at a WHCCAMP public hearing last year, initiated the following e-mail exchange with Dr. Ornish. The exchange is published with Dr. Ornish's permission.
London to Ornish (April 24)
Dean: I'm disappointed that the WHCCAMP never defined CAM; failed to acknowledge that CAM is marketing doublespeak used to conceal from consumers the shortcomings of a melange of mostly irrational, nonvalidated and invalidated methods; referred to CAM as if it is a genuine field of medicine needing special (i.e. legitimizing) regulation, oversight, and, most ominously, integration into our healthcare and medical education system; called for the President to establish an office at the "highest possible level" within the U.S. Department of Health and Human Services; recommended increased funding for research on "CAM practice and products" without regard to the likelihood that they might be shown to be effective.
I'm also disappointed that you did not sign on to the dissenting statement by [WHCCAMP commissioners] Dr. Fins and Dr. Low Dog. I would have thought that since you value scientific scrutiny of medical care you would have agreed with their position: "While dogmatic disbelief of everything that is not currently explainable is foolish, and indeed unscientific, it seems equally foolish to ask the taxpayer to bear the enormous expense of sorting out those areas that are plausible from those that are improbable."
I imagine that you found yourself in a difficult position when it came time to finalize the report. If you have any concerns or misgivings about the WHCCAMP report that you would like to discuss, please contact me.
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Ornish to London (May 5)
Thanks for your note. All of my concerns were added in a section of the introduction, so I did not feel compelled to write a separate dissent (this opportunity was also provided to them). This makes it clear that we are recommending only that CAM modalities (and, for that matter, conventional modalities) be included that are scientifically proven to be both safe and effective. I'm not sure why you or anyone else would have a problem with that.
The question is not, "Should Americans be using CAM modalities," because so many already are. As you know, more money is spent out of pocket for CAM modalities than conventional ones. Thus, I think it should be an important priority to increase funding for CAM research in order to bring some real science to this area which so badly needs it. Good science can help people sort out what works, what doesn't, for whom, and under what circumstances. I would think that you and your organization would welcome the idea of bringing good science to this area.
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London to Ornish (May 20)
It isn't good science or a good use of taxpayers' money to investigate methods of implausible value. [London's following sentences to Ornish were the text of the NCAHF Newsletter item TAXPAYERS FLEECED BY OAM/NCCAM PROJECTS from page 1 of March/April 2002 issue. The item concerned a paper by Saul Green published in The Scientific Review of Alternative Medicine.] Since the paper was published, grant award data have been removed from the Web page of the National Center on Complementary and Alternative Medicine.
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Ornish to London (May 20)
Thanks for your note. As you know, whether or not something is "good science" is a function of methodology and integrity, not whether the results show therapeutic efficacy. If many Americans are using alternative methods and well-conducted studies can show that these are of no value or even harmful, then those studies have great value in avoiding wasted time, resources, and keeping people out of harm's way.
And not all alternative interventions are worthless. When I began conducting research in 1977, the idea that the progression of coronary heart disease could be stopped or reversed by making intensive changes in diet and lifestyle was thought to be impossible; now, after 25 years of conducting randomized controlled clinical trials using quantitative coronary arteriography, cardiac PET scans, radionuclide ventriculography, and cardiac thallium scans, that idea has become mainstream.
I believe in the value of science in helping people sort out what works from what doesn't, for whom, and under what circumstances. To a priori believe that something is worthless before it is studied is as unscientific and anti-intellectual as believing something has value before it is studied.
Being a "true non-believer" is no more defensible than being a "true believer."
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London to Ornish (May 20)
As far as I know, the idea that the progression of coronary heart disease could be stopped or reversed by making intensive changes in diet and lifestyle does not conflict with laws of chemistry and physics. (I hope the results for your program can be independently verified and we can also learn if any components can be omitted.)
On the other hand, many CAM methods conflict with the laws of chemistry and physics. Thus, advocates of many CAM methods attempt to rewrite the laws of chemistry and physics to justify their work. They don't impress many chemists or physicists. Their extraordinary claims require extraordinarily strong evidence to support them (and rewrites of chemistry and physics textbooks accordingly), not findings for which chance or confounding are more plausible explanations.
It is scientific to discard what has been shown not to work and it is scientific to take an open-minded approach, but instead WHCCAMP took an empty-minded approach that doesn't call for discarding anything. (I imagine you can think of non-"CAM" practices to discard, just as I can. How about some "CAM" practices?)
In his 1988 Microeconomics textbook, Paul Heynes summed up empty-mindedness this way:
The search for knowledge of any kind necessarily begins with some commitments on the part of the inquirer. We cannot approach the world with a completely open mind, because we weren't born yesterday. And completely open minds would in any event be completely empty minds, which can learn nothing at all.
When people take an empty-minded approach in their attempts to be open-minded, it's no surprise to see them embrace and endorse all sorts of vitalistic preachings and phantom forces for "healing."
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Ornish to London (August 8)
Only in cults or fundamentalist religions are laws immutable, and I doubt that you want to be in that company. As you know, the history of science is replete with examples of laws that were revised, discarded, or expanded as new scientific data became available (e.g., Newtonian physics).
I agree that "extraordinary claims require extraordinarily strong evidence to support them," but how can one gather evidence without funding? It was very difficult for my colleagues and me to obtain funding for our early research from traditional sources (there was no NCCAM 25 years ago) as "everyone knew that the progression of coronary heart disease cannot be reversed." Yesterday's heresy may be today's orthodoxy.
Of course, there is not sufficient funding to study everything, but if a large number of people are using specific CAM modalities, then it can be as useful to do studies that show that these modalities are worthless as it is to show that they are effective. Given the amount of money that is spent each year on CAM treatments, I think funding for the NCCAM should be increased. I am all for good science and would think that you and your colleagues would be as well.
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The Medical Letter, an independent evaluation service for health care providers, issued a statement expressing doubt about the clinical efficacy and safety of spinal manipulation. [Vol. 44 (W1131C) May 27, 2002; www.medicalletter.org/freedocs/spinal.pdf] It noted the failure of clinical trials to demonstrate advantages over other treatments for neck pain, low back pain, and non-migrainous headaches, or advantages over sham interventions in treating asthma, dysmenorrhea, and enuresis. It stated:
Given the popularity of spinal manipulation, serious adverse effects are relatively rare, but repeated reports of arterial dissection and stroke associated with cervical spine manipulation and cauda equina syndrome [which has signs such as leg weakness, and loss of bladder or bowel control] associated with manipulation of the lower back suggest a cause-effect relationship. The vertebral artery, which is anchored to the base of the skull, appears to be most commonly affected after manipulation of the neck; vertebral artery dissection and thrombosis can cause brain-stem stroke.
NCAHF is an official supporter of the third annual National Fraud Awareness Week (August 4-10, 2002). According to the Web site for the week (www.fraudweek.com): "The Association of Certified Fraud Examiners in conjunction with leading public and private sector supporters utilizes the week to educate people about the prevalence of fraud and how to deter it." The Web site provides a link to NCAHF's Web site.
Fairview-University Medical Center announced that it will close its Mind Body Spirit Clinic on August 16. The clinic, co-sponsored by the University of Minnesota, opened in 1999 and has been losing hundreds of thousands of dollars per year ever since. Health insurers did not pay for most of the clinic's services which included massage, acupuncture, and so-called healing touch. Mary Jo Kreitzer, head of the university's Center for Spirituality and Healing said "None of [the similar] clinics around the country are making it." [Lerner M. Fairview-U plans to close alternative therapy clinic. Minneapolis Star-Tribune June 11, 2002.]
"Psychic" healing promoter and psychiatry professor Elisabeth Targ, MD died July 18, sixteen days before her 41st birthday and less than four months after she had surgery (April 5th) for a brain tumor diagnosed as glioblastoma multiforme. Dr. Targ directed the Complementary Medicine Research Institute of the California Pacific Medical Center-a part of the University of California School of Medicine-where she was the principal investigator of multi-year studies funded with taxpayers' dollars by the National Center for Complementary and Alternative Medicine on the effects of distant healing intention (e.g. prayer) on people with AIDS and on people with glioblastoma.
The minutes of the Spring 2002 general business meeting of the San Francisco Community Consortium (providers of care to people with HIV infection) included this request: "Please direct an intention for health and wellbeing in Elisabeth's direction." A Web site set up by people who had distant healing intentions for Dr. Targ (www.etarg.org) announced that it will provide a full obituary, the entire story of the ordeal of her illness, and information on her life's work.
To the Editor of The New York Times Book Review from William M. London, NCAHF Program Director:
In her May 12th review of Living Proof: A Medical Mutiny, Natalie Angier wrote that author Michael Gearin-Tosh "put together a semipersonalized program of Chinese breathing exercises, acupuncture, coffee and castor oil enemas, megadoses of vitamins and a diet rich in raw vegetables and fresh juices and stripped of salt, sugar and cooked fat" and survived eight years following his diagnosis of multiple myeloma. She suggested the possibility that Gearin-Tosh might have been a statistical outlier found in every patient population. But considering that the five-year relative survival rate for patients with multiple myeloma is more than 25%, Gearin-Tosh's survival is not extraordinary.
Although Angier wrote that Gearin-Tosh's diagnosis came with an "imminent-death verdict," it is not clear from her review that Gearin-Tosh actually wrote that his doctors told him his death was imminent. Did Gearin-Tosh's account of what his doctors told him about his illness accurately reflect what his doctors actually said? If his account was accurate, it is nevertheless possible that his doctors gave him an incorrect diagnosis or an overly pessimistic prognosis.
According to Angier "there is something to be said for challenging the use of toxic chemotherapy regimens when a cure is out of question." But most patients tolerate standard chemotherapy for multiple myeloma very well. Many patients experience no adverse reactions. And the chemotherapy has been shown to extend patients' lives-in many cases, for years. The same is true with chemotherapy for many other cancers.
Gearin-Tosh's refusal of chemotherapy and selection of an irrational treatment program followed a consultation with Ernst Wynder, a former professor at Memorial Sloan-Kettering Cancer Center. Angier wrote that Wynder said that "[i]f Gearin-Tosh so much as touched chemotherapy...he was 'a goner.'" Angier did not mention that Wynder developed in 1993 a very curable follicular thyroid cancer, initially refused surgery and radiation treatment, dabbled with a program similar to the one adopted by Gearin-Tosh, eventually submitted to surgeries after his cancer spread, and then died soon afterward in July 1999 at age 77.
Health fraud persists as a serious public health problem in part because of the failure of leaders in medicine and public health to speak out against the promotion of irrational healthcare methods. In an essay calling for cardiologists to be open-minded about patients' use of practices that have come to be known by the acronym "CAM," Douglas P. Zipes, MD, FACC, as president of the American College of Cardiology wrote:
The power of the mind as a tool for healing is an extraordinary but elusive attribute, often unsupported by conventional scientific data. But anecdotes attest to extraordinary things the mind appears to mediate from time to time -- help a mother wrench open a car door to pull her child from danger, walk on hot coals without burning one's feet (performed by my wife and me many years ago), or bend a spoon into modern art aided by the power of thought (Fig. 1 [a picture of a bent spoon]). These are the inexplicable events the human brain can help perform; no less miraculous may be the inner peace that comes with yoga or meditation or the benefits that seem to accompany sipping tea or undergoing acupuncture. We don't understand why these approaches may work, and some defy biologic mechanisms that we have been taught must underlie acceptable medical practices; but we must resist the temptation to discard all of them out of hand merely because we don't understand them. Experience one of them personally, and you become a believer. [Zipes DP. President's page: Complementary and alternative medicine: Ignore at doctors' and patients' peril. Journal of the American College of Cardiology 37:2166-2169;2001. See page 2168.]
The mother wrenching open a car door is a variation on an anecdote listed on various Web sites devoted to urban legends about a mother actually lifting the car to save her child. Walking on hot coals without burning one's feet has nothing to do with the power of the mind and much to do with walking fast on ash, which has poor heat conductivity. It would indeed be extraordinary if Dr. Zipes walked barefoot over hot frying pans without his feet getting burned. The spoon bending feats of those who claim psychokinetic ability are easily replicated using trickery. To consider reports of people experiencing inner peace miraculous suggests a low standard for declaring miracles. Reviews of the literature have not revealed any miraculous benefits accompanying sipping any kind of tea or undergoing acupuncture. A recent review in The Scientific Review of Alternative Medicine cast doubt on reports claiming effectiveness of acupuncture for specific conditions. President Zipes fails to appreciate how vulnerable people are to misinterpreting personal experiences and making errors of causal attribution related to their health status.
President Zipes referred to "CAM" practices as "blended medicine." He wrote that the term was suggested by Earl Bakken who founded the North Hawaii Community Hospital (NHCH), which on its Web site [planet-hawaii.com/nhch], promotes itself as "fast becoming a prototype for the careful integration of select complementary healing practices with high quality medical care." The Web site advertises the service of "Healing Touch"-a practice that provides neither healing nor touch. It is one of the first hospitals in the United States to include licensed naturopaths, chiropractors, and acupuncturists on its consulting medical staff.
According to Dr. Zipes: "American College of Cardiology members are also doing their part to help distinguish between snake oil and useful remedies." [p. 2168]