September 26, 2002Kimball Atwood, M.D. xxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxx
I have now had time to look into the allegations in your letter of June 14th which, incidentally, I shared with Dr. David Eisenberg and he with several others. I have sought consultation about our exchanges and the gist of my response follows.
Some of your concerns and allegations are very helpful and constructive. Perceptions are particularly important in controversial fields where there is limited objective proof. Your cautions and interpretations in this area have been very useful to us.
Some of what you said is just plain wrong. This includes the allegation the Harvard has “a stake” in the area and therefore would not look into your allegations objectively. Relatedly, Dr. Howard Koh has written us a construction of the events in the Massachusetts Special Commission that is strikingly different from yours. And Dr. Anthony Komoroff has pointed out that many of your comments about the InteliHealth treatment of CAM are now grossly out of date as the material inherited from another provider has been reviewed by HMS faculty and modified. [Indeed, you have referred in other correspondence to modifications you have noticed.] Dr. Komaroff also commented on the misleading way your citation the treatment of homeopathy was disconnected from the rest of the paragraph.
Some of what you said is a matter of taste or interpretation, where even well intentioned people may disagree. In this particular area I have weighed your arguments carefully and, in places, learned from them.
But I think the biggest difference may be in a misperception about what our purposes are. The Council of Academic Deans of Harvard Medical School approved beginning a Division of Research and Education in Complementary and Alternative Therapies with exactly the focus described. Our goal is to do peer-reviewed basic and clinical research on the claimed, but unproven, efficacies of complementary and alternative approaches to therapeutics. The recent scientific sessions and requests for proposal held by the Division are clear testament to this intent. In addition, in common with the Association of American Medical Colleges and most of the allopathic schools of medicine, we intend to teach our students something about CAM and in particular how to assess its claims rigorously. We do not, repeat NOT, have any intention of making our students CAM practitioners. They have enough to do learning what we have always focused on.
Daniel D. Federman, M.D.
cc: David M. Eisenberg, M.D.
Archive for Medical Ethics
I only recently began contributing to SBM, bringing not any particular expertise or scholarship but rather the perspective of a student. My goal in blogging is not to focus on issues specific to my school, of which I am quite fond and proud in general. Instead I hope to use my experiences, which SBM editors and readers tell me are not unique, to illustrate how CAM can interact with medical education. When writing, I constantly remind myself, “Everything you know about homeopathy and naturopathy was heavily influenced by the SBM docs, so try not to parrot their arguments lest you look like a brainwashed fanboy. Focus on relaying your experiences and trust readers to reach their own conclusions.” As a result, some have called my critiques a bit mild, but I can accept blandness to avoid seeming arrogant beyond my qualifications.
I was surprised, therefore, to be told by leaders of a campus CAM group that my most recent SBM post was full of personal attacks. (more…)
In Parts I and II of this series* we saw that from 2000 to 2002, key members of the Harvard Medical School “CAM” program, including the Director, had promoted quackery to the legislature of the Commonwealth of Massachusetts. We also saw other explicit or tacit promotions by Harvard institutions and professors, and embarrassing examples of such promotions on InteliHealth, a consumer health website ostensibly committed to “providing credible information from the most trusted sources, including Harvard Medical School….”
Those points were made in an essay that I sent in the spring of 2002 to Daniel Federman, the Senior Dean for Alumni Relations and Clinical Teaching at Harvard Medical School (HMS). I also sent Dr. Federman a treatise on homeopathy, including several examples of credulous Harvard professors and misrepresentations aimed at students, patients, and the public. Much of the content of that treatise has been covered by the series on homeopathy† with which I began my stint here on SBM, so here I’ll post only the parts relevant to promotions by academic physicians, including those at Harvard. There is a bit of redundancy involving InteliHealth, but please bear with me if you’ve made it this far; the discussion will be meatier than the short summary in Part II.
In Part I of this series† we saw that in 2001 Dr. David Eisenberg, the Director of the Harvard Medical School Center for Alternative Medicine Research and Education (CAMRE), and Atty Michael Cohen, the CAMRE’s Director of Legal Programs, had contributed to a report commissioned by the Commonwealth of Massachusetts that would, if accepted as valid by the legislature, provide state protection for a group of quacks to practice ‘medicine.’ We also saw that Dr. Eisenberg had accepted funds from this very group, without having disclosed that information to the relevant state Commission. We saw examples of the quackery that the group espouses, including methods advocated by Thomas Kruzel, the Chief Medical Officer of the school that had contributed money to Dr. Eisenberg’s Harvard “Complementary and Integrative Medicine” course.
We continue now with the essay that I sent in the spring of 2002 to Dr. Dan Federman, the Senior Dean for Alumni Relations and Clinical Teaching at Harvard Medical School (HMS). As before, I’ve provided hyperlinks to many of the citations that I included in my original essay; some, however, are no longer available.
The American Association of Health Freedom
Kruzel and Harvard’s Michael Cohen are listed as key figures—Kruzel the Secretary, Mr. Cohen the only lawyer on the Advisory Board—in a lobbying organization known as the American Association of Health Freedom (AAHF). Formerly known as the American Preventive Medical Association (APMA), it was founded by Julian Whitaker, MD, a former orthopedic surgical resident who decided that “natural therapies” offered a more lucrative career path. Its purpose, as suggested by the standard euphemism, is to convince government of the validity of dubious medical claims through political influence rather than science. The AAHF lobbies heavily for the passage of the annually defeated federal “Access to Medical Treatment” act, which would allow quacks to prey freely on unwary consumers.
Here at Science-Based Medicine we’ve been getting a lot of letters from medical students. This is a good thing and a bad thing. I’m glad people see us a a resource for SBM, but I’m unhappy that medical students: 1) need us; 2) don’t have someone to approach on campus. Let’s explore some of the more subtle ways cult medical practices infiltrate medical education.
In order to give all of their students experience in outpatient medicine, most med schools must reach out to the community. Sure, some med schools have big enough clinics to support an experience for all of their students, but that’s the minority. For their internal medicine, pediatrics, and family medicine rotations, med students often spend time at private doctors’ offices. These offices are minimally vetted, and I’d venture to guess that the vetting does not include checking for non-standard practices. In fact, schools are so desperate for spots, that almost any office will do. It’s good for students to see how medicine is practiced in the “real world” but that real world often involves cult medicine practices. Along the same lines, many practitioners are not up to date on the most recent best practices. I remember a family doc I worked with who used to give huge doses of intramuscular steroids to people for seasonal allergies. This isn’t the best idea, but I was a student. Who was I to tell him how to practice medicine?
We don’t police our colleagues very effectively—we have surrendered that duty largely to the courts. However, if doctors want a medical school affiliation, it seems a small price to allow the school to come in and see if the office practices medicine according to the standard of care. In addition to checking for the most minimal quality standards, it would rule out docs who are offering voodoo in place of medicine.
Early in the history of this blog, I wrote a rather long post expressing my dismay at the infiltration of unscientific “complementary and alternative medicine” (CAM) or “integrative medicine” (IM) modalities into American medical schools. In it, I listed the medical schools that had embraced pseudoscience through having started a CAM/IM program (a list desperately in need of an update). Moreover, we have also complained vociferously here about a clear effort on the part of advocates of faith-based medicine to infiltrate bastions of science-based medicine and to piggyback their agenda onto President Obama’s health care reform initiative in a clear political strategy to slip CAM/IM into any health care reform legislation as a form of “preventative medicine.” It’s all part of a multi-pronged strategy to claim popular and legal legitimacy in the absence of scientific legitimacy. At one point I even despaired because of the apparent success of half physician, half CAM huckster Dr. Andrew Weil at developing a CAM/IM curriculum that would be part of the mandatory training program in several family medicine residencies, while the rest of us watch Senator Tom Harkin try to promote pseudoscience in the halls of the Senate.
However, since one of our newest co-bloggers, medical student Tim Kreider, arrived, I’ve come to appreciate that medical schools and medical school curriculae are ground zero in the battle for science- and evidence-based medicine. Besides the infiltration of non-science-based modalities into the standard curriculum, another technique for making medical students believe that woo is equal to science is the student “campus CAM group” that invites, for example, homeopaths and naturopaths to give talks to medical students, too many of whom are too timid to challenge them on their pseudoscience. However, a reader of a “friend” of mine wrote me an e-mail that truly appalled me. In fact, it appalled not just me, but all of my co-bloggers who read it. It’s from a medical student in an American medical school. It’s not Harvard or a huge famous medical school. However, it is in medical schools like this one where the vast majority of medical students are trained in this country. If the infiltration of CAM/IM into medical schools continues in this way, we’ll have more than just “integrating” woo into the medical school curriculum from day one. We’ll have more tales like this; eventually, no one will find such tales unusual or even unacceptable anymore. The shruggies will no longer even shrug anymore. Such clinics will become simply the way medical students are educated. The following e-mail is de-identified, and I’ve edited it a bit to make as sure as I can that it is not traceable:
When beginning a discussion of a controversial topic I like to establish the common ground upon which most or all people can agree. Everyone seems to agree that real conflicts of interest in medical research and practice is a bad thing and steps should be taken to minimize, eliminate, and illuminate any such conflicts. The controversy revolves around what constitutes a real conflict of interest.
There is broad agreement that researchers should not have a personal financial stake in the outcome of their own research – they should not make more money if their research is positive than if it’s negative. That creates a clear and powerful bias. There is also now broad agreement and adoption of standards that speakers, authors, and researchers should disclose any potential conflicts of interest – primarily the source of their funding. If someone is being paid by a drug company to say that their drug is effective for a particular disease, they should disclose that up front.
These same standard are now being applied to IRBs – institutional review boards, and that seems apprpriate. Every institution that does biomedical research must have an IRB, which is a committee of appropriate professionals (and there are rules as to the IRB’s constitution) that review all human research proposals to make sure they meet ethical guidelines and that subjects are adequately protected. This is a good system that generally works.
Is it ethical to overstate the efficacy of a treatment option, if it might lead to a patient’s enhanced experience of that treatment? Your response to this question may reveal the degree to which you favor Complementary and Alternative Medicine (CAM). Let me explain.
As far as I can tell, no CAM treatment has been proven effective beyond placebo. (If you’re not convinced of this, I suggest you take a look at Barker Bausell’s book on the subject.) That means that treatments like acupuncture, homeopathy, Reiki, energy healing, Traditional Chinese Medicine (such as cupping), and others (like “liver flushes”) perform about as well as placebos (inert alternatives) in head-to-head studies. Therefore, the effects of these treatments cannot be explained by inherent mechanisms of action, but rather the mind’s perception of their value. In essence, the majority of CAM treatments are likely to be placebo therapies, with different levels of associated ritual.
For the sake of argument, let’s assume that CAM therapies are in fact placebos – the question then becomes, is it ethical to prescribe placebos to patients? It seems that many U.S. physicians believe that it is not appropriate to overstate potential therapeutic benefits to patients. In fact, the AMA strictly prohibits such a practice:
“Physicians may use [a] placebo for diagnosis or treatment only if the patient is informed of and agrees to its use.”
Moreover, a recent article in the New England Journal of Medicine concludes:
“Outside the setting of clinical trials, there is no justification for the use of placebos.”
However, there is some wavering on the absolute contraindication of placebos. A recent survey conducted by researchers at the Mayo Clinic asked physicians if it was permissible to give a dextrose tablet to a non-diabetic patient with fibromyalgia if that tablet was shown to be superior to no treatment in a clinical trial. In this case 62% of respondents said that it would be acceptable to give the pill.
The authors note:
“Before 1960, administration of inert substances to promote placebo effects or to satisfy patients’ expectations of receiving a prescribed treatment was commonplace in medical practice. With the development of effective pharmaceutical interventions and the increased emphasis on informed consent, the use of placebo treatments in clinical care has been widely criticized. Prescribing a placebo, it is claimed, involves deception and therefore violates patients’ autonomy and informed consent. Advocates of placebo treatments argue that promoting the placebo effect might be one of the most effective treatments available for many chronic conditions and can be accomplished without deception.”
How do you feel about placebos? Are they a legitimate option in some cases, or a violation of patient autonomy and informed consent?
Last week, two events took place in Washington that ought to inspire trepidation in the minds of all who value ethical, rational, science-based medicine and ethical, rational, biomedical research. One was the Senate Panel titled Integrative Care: A Pathway to a Healthier Nation, previously discussed by my fellow bloggers David Gorski, Peter Lipson, and Steve Novella, and also by the indefatigable Orac (here and here); the other was the ”Summit on Integrative Medicine and the Health of the Public“ convened by the Institute of Medicine (IOM) and paid for by the Bravewell Collaborative, previewed six weeks ago by fellow blogger Wally Sampson. This post will make a few additional comments about those meetings.
Senator Harkin and the Scientific Method
Thanks to Dr. Lipson, I didn’t have to listen to the Senate Panel video to find out that Senator Tom Harkin (D-Iowa) made this statement of disappointment regarding his own creation, the National Center for Complementary and Alternative Medicine (NCCAM):
One of the purposes of this center was to investigate and validate alternative approaches. Quite frankly, I must say publicly that it has fallen short. It think quite frankly that in this center and in the office previously before it, most of its focus has been on disproving things rather than seeking out and approving. (from last week’s hearings, time marker approx. 17:20)
Are scientists at the NIH really too afraid of Harkin to explain to him how science works? Apparently so. Otherwise Harkin might learn that his statement is more wrong-headed than it would be for one of us to complain that the Supreme Court ought to assume that a defendant is guilty until proven innocent, rather than the other way around. In scientific inquiry, for those who don’t know, good experimental design is always directed at disproving a hypothesis, even one that pleases its investigator. The rest of Harkin’s sentiment—”seeking out and approving”—is incoherent.
The Selling of ‘Integrative Medicine’: Snyderman Trumps Weil
Spin doctors shilling for ‘integrative medicine,’ which the NCCAM defines as “combining treatments from conventional medicine and CAM,” appear to have now decided that subtler language is more likely to sell the product. We’ve previously seen an example offered by ‘integrative’ Mad Man Andrew Weil:
This week we’ll take a break from lambasting the National Center for Complementary and Alternative Medicine, as worthy as that task is, in order to confront some of the latest events involving the pseudomedical cult that calls itself “naturopathic medicine.”* Intrepid nurse and anti-healthfraud activist Linda Rosa reports that Colorado is dangerously close to becoming the next state to endorse ”NDs” as health care practitioners, and Scott Gavura of Science-Based Pharmacy called my attention to a report that British Columbia is considering enlarging the scope of practice for NDs, who are already licensed there, and that Alberta is on the verge of licensing them. In each case, those whom the public trusts to make wise decisions have betrayed their ignorance of both pseudomedicine and the realities of governmental regulation.
To explain why, it will first be necessary to make a few assertions, which are linked to developed arguments where necessary: