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Science, Reason, Ethics, and Modern Medicine, Part 3: Implausible Claims and Formal Ethics Statements

The Ethics of Implausible Medical Claims (IMC)

In Part 2 of this series* we learned from David Katz, MD, a key member of the Yale School of Medicine’s “integrative medicine” program, that he had been “pushed toward integrative medicine by the needs of [his] patients.” We also learned that Dr. Katz’s rationale for this decision justifies a wide range of quackery—both in principle and in fact. I had previously alluded to arguments like those of Dr. Katz in a comment on SBM several months ago:

…we must be true to medical ethics, no matter what else we do. If that means losing a few patients, so be it. Patients are free agents, and we can only do so much to influence them. To the extent that we don’t do that as well as we might (which is obviously true in some cases), we might do better. But our ethical obligation is to science and truth; it is not, as many modern physicians would have it and as much as we may lament sometimes losing patients to woo, to seducing patients to stick with us no matter what, if the “what” includes engaging in a charade about “integration” or “complementary therapies”…

Realizing that some might argue that physicians’ obligations to patients ought to trump their obligations to “science and truth,” I later revised that statement:

Several weeks ago I argued here that a physician’s primary ethical obligation is to science and truth. In retrospect I probably should have put it a slightly different way: a physician’s primary ethical obligation is the same as everyone else’s. It is to honesty and integrity. For physicians, however, that means being true to real medical knowledge, among other things, and real medical knowledge comes from science.

In spite of that revision, two readers whose opinions I respect challenged my assertion. Dr. Peter Moran’s worthy efforts to educate patients about the realities of “alternative” cancer treatments are considerable. Here on SBM he has repeatedly challenged us to explain how, when confronted with testimonials of “alternative” cures, we ought to respond without using “a high-handed, ‘we know best’ stance” and thus “appear to want to distance [ourselves] from the intimate concerns of [our] patients.” I was thinking mainly of him when I wrote the revision above, because on this key topic—how to respond ethically, but with compassion, to patients who want to believe in implausible treatments—I’ve come to think of Dr. Moran as the “conscience” of Science-Based Medicine. Those with cancer, he has reminded us, “are folk very like you and me who are simply grasping at any straw that might save or prolong their lives.” His take on why IMCs are appealing to those with less ominous problems is well-developed and agrees with my own, mostly. We part ways, however, when he concludes (also here and here) that ethical physicians might have good reasons—unlike Dr. Katz’s—to entertain benign, if implausible treatments:

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Posted in: Health Fraud, Medical Ethics, Science and Medicine

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Science, Reason, Ethics, and Modern Medicine, Part 2: the Tortured Logic of David Katz

In Part 1 of this series* I asserted that a physician’s primary ethical responsibility is to honesty and integrity, which in turn must be largely based on science and reason (I apologize if that sounded preachy; if there had been more time I might have couched it in more congenial terms). I mentioned the fallacious reasoning whereby proponents of implausible medical claims (IMC) point to real and imagined weaknesses of modern medicine to justify their own agenda. I offered, as a favorite example of such proponents, science-based medicine’s having not yet solved every health problem. This week I’ll show how this version of the tu quoque fallacy has led a prestigious medical school to advocate pseudoscience-based medicine.

Modern Medicine: a Brief, Fragile Commitment to Science

First, a few more words about the title of this series. Modern medicine is not science, even if it draws upon science for its knowledge: it is an applied science similar, in that sense, to engineering. Modern medicine is also not synonymous with the “medical profession,” if the term means the collection of all people with MD degrees. That is true for the obvious reason that medicine is more than people, but also because a small but loud minority of MDs rejects modern medicine and science.

Modern medicine has made an uneven commitment to science and reason. At its best, it has formally embraced them in the faculties and curricula of medical schools, in its codes of ethics, and in its contributions to knowledge, both basic and applied, over the past 150 years or so. As discussed last week, it is because of science and reason that modern medicine has made dramatic, revolutionary advances in a very short time. That is what distinguishes it from every other “healing tradition,” and why there is no legitimate competition. The only valid medicine in the modern world is science-based medicine—not “allopathic,” “Western,” “conventional,” “regular,” “integrative,” “complementary and alternative,” or any of the so-called “whole medical systems.” The pre-scientific (and, ironically, “post-modern”) designation of “schools” or “systems” of medicine, so stridently trumpeted by quacks, is an anachronism—even if it persists in archaic, governmental edicts.

Compared to the actual sciences, however, modern medicine’s commitment to science is fragile. Its recent confusion of error-prone clinical trials with science itself—the project called “evidence-based medicine”—has been a mixed blessing. Its growing tolerance of charlatans and crackpots, at times elevating them to celebrity status, would be unthinkable in physics or biology. Its dalliances with quackery, so depressingly recounted in recent posts here, here, here, and here, are why your SBM bloggers do what we do. Biologists, other scientists, and intellectuals in general have joined the battle against the pseudoscientific travesty known as “intelligent design.” Many physicians, however, even of the brainy, academic variety, act as though the equally pseudoscientific but more dangerous travesty known as “integrative medicine” is either a good thing or, at least, is a necessary addition to medical school curricula.

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Posted in: Health Fraud, Medical Academia, Medical Ethics, Science and Medicine

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A Guide for Confronting Patients

I sometimes lecture on science-based medicine to my colleagues and one of the most common questions I get is how to deal with a patient who expresses belief in unscientific treatments. The dilemma for the physician is that professionalism requires that we do not confront patients regarding their personal beliefs. We are there to inform and advise, not preach. And yet proper medical care is often hampered by unscientific beliefs on the part of patients.

David wrote previously about a case he reviewed in which a woman with a very treatable early stage of breast cancer opted for “alternative” treatment rather than the standard treatment, which carries a > 93% good outcome. As a result her cancer progressed horribly – but she clung to belief in CAM despite its obvious failure in her case. This story highlighted the fact that giving patients proper medical advice sometime requires confronting their false beliefs.

Unscientific and bizarre medical practices are in vogue and are increasingly infiltrating the medical system through a combination of misguided political correctness, stealth, and apathy. This is exacerbating the dilemma for science-based practitioners who are caught between the imperative to do the right thing in accordance with evidence-based guidelines and the default respect for the patient and the desire to maintain a therapeutic relationship.

In my experience, however, these two goals do not have to be mutually exclusive. An uncompromising but non-judgmental approach works very well.

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Posted in: General, Medical Ethics

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Science, Reason, Ethics, and Modern Medicine Part 1: Tu Quoque and History

Several weeks ago I argued here that a physician’s primary ethical obligation is to science and truth. In retrospect I probably should have put it a slightly different way: a physician’s primary ethical obligation is the same as everyone else’s. It is to honesty and integrity. For physicians, however, that means being true to real medical knowledge, among other things, and real medical knowledge comes from science. That is what this and the next several posts will be about.*

First, a little Tu Quoque

After reading some of the comments that followed my posting of two weeks ago, I reluctantly thought to add a few words about the medical profession’s view of physicians selling drugs. It felt tiresome to have to address the issue, because it is beside the point. The series was about “naturopathic medicine,” not about modern medicine. If readers who understand the point will excuse the interruption, I’ll quickly attempt to explain why by posing two extreme possibilities: If MDs are entirely innocent of the relevant breach of ethics, what would that have to do with naturopaths selling drugs? But if MDs are entirely guilty, two wrongs don’t make a right—demonstrating the same irrelevancy.

That is why the ”you should talk” sneer is known, in debate, as the tu quoque (“you too”) fallacy. It’s funny how parents seem to recognize it when faced with children who, in seeking permission to engage in dubious activities, invoke the parents’ own sordid histories or the equally irrelevant, alleged prerogatives of other people’s children. Yet the same parents appear to forget it in other contexts.

I was also weary and wary of those who would draw me into a strawman debate pitting the medical profession against any group of sectarian health advocates. I have only a small sense of “solidarity” with the group of people who have MD degrees, and even less so with organized medicine. My first allegiance, as I’ve explained elsewhere, is to science and reason. Those modes of inquiry, together with their obvious bearing on the integrity of all claims about nature, are the bases for my objections to naturopathy and to pseudoscience in general. The medical profession per se is related but not central to the issue. While thinking about these things, it dawned on me that a discussion of why that is might be useful. (more…)

Posted in: Medical Ethics, Science and Medicine

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Should We Study Chelation for Autism?

The National Institute of Mental Health (NIMH) supports doing a study on the effects of oral chelation therapy in autism. The proposal is highly controversial, is drawing criticism from many scientists, but has popular support among parents who believe this type of therapy might help their children with autism. The proposal raises many questions about the ethics of biomedical research.

Chelation and Autism

Chelation therapy is a legitimate FDA approved treatment for heavy metal poisoning. The drugs used for chelation, such as disodium EDTA, bind to heavy metals so that they can be removed from the body. Chelation drugs can be given either orally or intravenously. The treatment is somewhat risky because it can also remove needed electrolytes, like calcium, from the body or causes shifts in the electrolytes that can cause arhythmias and changes in brain function. There are reported cases of cardiac arrest and death due to chelation.

Chelation therapy has a long history of quackery – not for its intended use but for other uses for which there is no evidence. The classic example of this is the use of chelation therapy to treat atherosclerosis to prevent heart disease. This claim persists despite the utter lack of evidence for efficacy and the fact that all proposed mechanisms have been shown to be flawed or false.

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Posted in: Clinical Trials, Medical Ethics, Neuroscience/Mental Health, Vaccines

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Another State Promotes the Pseudoscientific Cult that is “Naturopathic Medicine.” Part 4

The “Science” and Ethics of “Natural Medicines” (and Nutrition) cont.

This is the continuation of a discussion concerning the explicit claim of “naturopathic physicians”* to being experts in the use of “natural medicines,” defined as “medicines of mineral, animal and botanical origin.” Last week’s post established that the cult has chosen to profit from the “retail selling of medications,” as evidenced by the relevant Position Paper of the American Association of Naturopathic Physicians (AANP) and by that organization’s having made a deal with a drug company to make profits for both itself and its members.

The Position Paper observes that such selling “could be construed as a conflict of interest on the part of the physician.” That is true, if embarrassingly understated: anyone representing himself as a physician, who both recommends and sells the same medications for a profit, has conflicting interests. The conflict undermines his claim to offering responsible advice regarding those medications, and as such is a breach of medical ethics.

The AANP’s deal with MotherNature.com was even worse: by promoting such peddling in a formal, institutional fashion, NDs and their national organization went beyond the already widespread problem of practitioners hawking drugs. It is unclear whether the deal still exists, by the way: MotherNature.com was a victim of the “dot com” bust of a few years ago. It has since been resurrected, but a quick perusal of its new website fails to reveal the old AANP relationship. Nevertheless, I have seen no evidence to suggest that the AANP has changed its view of that sort of deal.

Are NDs Truly “Learned Intermediaries” in the Use of “Natural Medicines?”

This entry discusses the other part of the claim of expertise: that, aside from their conflicting interests, NDs have real knowledge of “natural medicines.” It will become clear during the discussion that the purported naturopathic expertise in nutrition—another standard claim—is also under review. I will include or cite abundant evidence for my assertions, because I’ve found that a predictable response of representatives of the highest levels of “naturopathic medicine” is to flatly deny them. I apologize again for including excerpts from previously published material.

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Posted in: Book & movie reviews, Health Fraud, Herbs & Supplements, Medical Ethics, Nutrition, Politics and Regulation

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Another State Promotes the Pseudoscientific Cult that is “Naturopathic Medicine.” Part 3

The “Science” and Ethics of “Natural Medicines”

This and the next entry in the current “Naturopathic Medicine” series* deal with the cult’s claim of expertise in “natural medicines” or “natural remedies.” These include herbs (“botanicals”), glandular extracts, vitamins, and minerals. A large fraction of the Textbook of Natural Medicine (TNM), “the most thoroughly researched and carefully referenced text on natural medicine,” is devoted to these agents.[1] They are keys to the practice of naturopathy and to a core claim of “naturopathic physicians” that legislators tend to swallow: that NDs offer something that most MDs do not.

During the deliberations of the Massachusetts Special Commission, NDs produced Dr. Alan Trachtenberg, a fresh-faced ingenue who had briefly been Acting Director of the federal Office of Alternative Medicine, to testify on their behalf. He suggested to the Commission that naturopaths could be the “learned intermediaries” that the public needed to help make sense of the myriad “natural remedies” that became freely available in the wake of the Dietary and Supplement Health and Education Act of 1994 (DSHEA). This is from his written testimony:

Another advantage of state licensure, is that the holder of a professional license who provides or recommends a product, then becomes responsible for the quality and safety of a product. In an unregulated marketplace, such a learned intermediary can be invaluable to the consumer. Since naturopaths do often provide dietary supplements and herbal products directly to their patients, it is vital that they have an enforceable code of professional ethics. Such a code of ethics becomes enforceable with State licensure.

It is also beneficial for the patient to have a practitioner who knows enough about biochemistry, physiology, pharmacology, and physical diagnosis to adequately assess a patient’s clinical response to a product. These products are essentially complicated but unregulated drug mixtures. My understanding is that licensable naturopathic doctors have all taken these courses during their four years of training and passed standardized exams that test their mastery. There is no such quality assurance for the other kind of naturopathic practitioner.

Instead of relying on Dr. Trachtenberg’s “understanding,” let’s submit his two assertions—that of a “code of ethics” and that of “mastery” of the topic of “natural medicines”—to real scrutiny. In doing so I confess that I have plagiarized, to some extent, pieces that I’ve written elsewhere.

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Posted in: Health Fraud, Herbs & Supplements, Medical Ethics, Politics and Regulation

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The media versus the frontiers of medicine and surgery

A couple of months ago, one of my esteemed co-bloggers, Wally Sampson, wrote an excellent article about borderlines in research in conventional medicine. Such borderlines are particularly common in my area of expertise (cancer, which is also Dr. Sampson’s area of expertise) because there are so many cancers for which we do not as yet have reliably curative therapies. Patients faced with unresectable pancreatic cancer (as, for example, Patrick Swayze and the President of the American Medical Association have been diagnosed with) or metastatic solid cancers against which medicine generally has mostly palliative treatments, it is very tempting to take a “what have we got to lose?” attitude and pursue increasingly aggressive therapies that may actually shorten what little life a patient has left, all too often making that little bit of life more miserable than it had to be. As Dr. Sampson described in great detail, this sort of push to the borderlines and beyond led to the widespread acceptance during the 1990s of bone marrow transplantation as a treatment for advanced or inflammatory breast cancer based on uncontrolled studies that suggested a benefit. Later studies demonstrated no survival benefit (and possibly even a detriment), and that, or so it would seem, was that.

Except it wasn’t. Indeed, the other point that Dr. Sampson made was how the press covers these sorts of issues. He discussed a story that appeared in the San Francisco Chronicle about a young woman with advanced breast cancer who underwent stem cell transplantation for stage IV breast cancer at M.D. Anderson Cancer Center and was embroiled in a fight with Kaiser Permanente, her insurer, which refused to cover the treatment because it was deemed experimental and was at the time covering the cost of radiation therapy but refusing to cover the costs of extra followup scans required by the M.D. Anderson protocol. The article, not surprisingly, covered the story from the angle of the brave young cancer victim being further victimized by a greedy insurance company. And Evanthia Pappas is no doubt brave, and no one could read about her plight without rooting for her to beat the odds. The problem is that no consideration was given to just how unlikely this incredibly expensive treatment was to benefit her and whether it was even ethical to be doing such a study in which the patient bore over $200,000 of the cost for a treatment that was indeed experimental and being studied in an uncontrolled clinical trial. There are some very thorny medical, ethical, and financial issues there indeed.

Perhaps the reason Dr. Sampson’s post resonated with me was because it reminded me of a story that was extensively discussed last year, so much so that I saved the link to it. The story (Cancer Patients, Lost in a Maze of Uneven Care) appeared on the front page of the New York Times last summer. The article in question starts out by telling a truly sad story about a 35 year-old woman who, after giving birth, was diagnosed with Stage IV colon cancer as the human interest “hook” with which to represent what is described as a systemic problem with cancer care in this country:
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Posted in: Cancer, Medical Ethics, Science and Medicine, Science and the Media, Surgical Procedures

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Stem Cell Therapy and the Need for Transparency

Dr. Geeta Shroff is an Indian physician who is running a New Delhi clinic offering embryonic stem cell therapies for a large number of various medical conditions. The only thing these medical conditions have in common is that they are incurable. Indian law allows for the use of unproven treatments for terminal or incurable diseases. I cannot know Dr. Shroff’s intentions, but she has rejected the ethics and standards of science-based medicine and in so doing has transformed herself into a dangerous charlatan.

Embryonic Stem Cell Therapy

Embryonic Stem Cells (ESC) are controversial because of the ethical and moral consideration regarding harvesting ESC and the rights of an embryo. But that is not what makes Dr. Shroff’s treatments controversial, and not what I am going to write about here. The question, rather, is the state of the science of ESC therapy.

ESC’s are scientifically interesting because they have the potential to turn into any type of cell in the body. The hope for ESC therapy is that they can be used to replace dead or abnormal tissue in the body, something which is not now possible for many conditions. (Organ and bone marrow transplants are among the current treatments to replace failing tissue.) For example, an injured spinal cord might be repaired by using ESC’s to replace the damaged motor neurons and reestablish a connection between the brain and muscles. Atrophied muscles themselves can be repaired by having ESC’s turn into working muscle cells.

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Posted in: Clinical Trials, Medical Ethics, Science and Medicine, Science and the Media

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The TACT is at least as Bad as We Predicted

I had wanted to follow Dr. Sampson’s discussion of “Healing Touch” with one of my own, because I had an interesting experience with one of its proponents years ago, and I’ll do that soon. I had also wanted to begin a series of posts about acupuncture, which I’ll also do eventually. Just yesterday, however, Liz Woeckner, co-author of our recently published critique of the NIH Trial to Assess Chelation Therapy (TACT), made a startling discovery: the TACT “Portal” website, intended for investigators and others associated with the trial and previously password protected, is now available to anyone: http://www.chelationwatch.org/s/tact/index.html It is a goldmine of information and I’ve barely begun to look at it, but so far it verifies much of what we’ve written and more. For example, the latest version of the Consent Form is dated 2006 and includes this statement under “risks”:

EDTA, or ethylenediamine tetraacetate is in the chelation solution. It is approved for use by the FDA as a treatment for lead poisoning but not for coronary artery disease.

Yet three Investigator Brochures, dating back to 2003, contain this language:

Edetate disodium USP should not be confused with its calcium salt (calcium edetate), which is used to treat lead toxicity.

We had called attention, in our article, to TACT literature repeatedly conflating Na2EDTA and the safer CaNaEDTA. Now we have reason to believe that this has been done cynically, with eyes wide open.

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Posted in: Clinical Trials, Medical Ethics, Politics and Regulation, Science and Medicine

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