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The CAM Docket: Boiron I

Author’s note: This will inaugurate a series of occasional posts observing the wheels of justice grind slowly over “CAM.”

In a previous post, I posited that CAM practitioners might well subject themselves to liability for the tort of fraudulent misrepresentation. This misrepresentation could be based on both the lack of scientific evidence of effectiveness and the lack of scientific plausibility for their treatments. One example was homeopathy, which, as Dr. Steven Novella aptly stated,

we can summarize . . . by saying it has extreme implausibility and the clinical evidence shows lack of efficacy. It should not work, and it does not work. There is no legitimate controversy about this.

In the last couple of years five lawsuits have been filed against Boiron, a somewhat prickly company based in France and the world’s largest manufacturer of homeopathic products. In 2011, Boiron had $520,000,000 in sales, although some of this revenue comes from its other products, such as dietary supplements. The plaintiffs are consumers who purchased Boiron’s homeopathic “remedies” and who now allege that they were deceived by Boiron’s false and misleading representations, allegations Boiron denies. Four of the lawsuits are pending in California and one in Illinois.

All of the suits are filed as putative class actions, which generally proceed like this: a plaintiff claims she was injured in a certain manner by the defendant’s conduct and that there are numerous others who were injured in the same, or a similar, way. She asks the court to allow her to proceed with a class action in which she will represent all those other people. In essence, the class members become plaintiffs themselves and are bound by the results of the case. (They can’t, for example, bring their own individual lawsuits.) If the plaintiff is successful, all class members are entitled to relief, including monetary damages. (more…)

Posted in: Homeopathy, Legal, Politics and Regulation

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The Marino Center for Integrative Health: Hooey Galore

Two weeks ago I promised that I would discuss the Marino Center for Integrative Health, identified in the recent Bravewell report as having a “hospital affiliation” with the Newton-Wellesley Hospital (NWH) in Newton, Massachusetts, which is where I work. I also promised in that post that I’d provide examples of ‘integrative medicine’ practitioners offering false information about the methods that they endorse. I’d previously made that assertion here, and Jann Bellamy subsequently discussed its legal and ethical implications here. The Marino Center is a wellspring of such examples.

A Misleading ‘Affiliation’

Let’s quickly dispel the “hospital affiliation” claim. According to the Marino Center website:

Hospital Affiliations

In support of our services and to ensure that our patients have access to exceptional tertiary care, the Marino Center maintains deeply established relationships and affiliations for referrals and admitting privileges with major medical facilities in the Boston area.

The Marino Center:

  • Is a proud member of the Partners Healthcare family
  • Is affiliated with Newton Wellesley Hospital
  • Makes referrals to Mass General Hospital, Dana Farber, Children’s Hospital and more

Well, it wouldn’t surprise me if the Marino Center is a ‘member’ of the Partners Healthcare family, which includes not only the Newton-Wellesley Hospital, but lesser known entities such as the Massachusetts General Hospital and the Brigham and Women’s Hospital. After all, there are already unfortunate pseudomedical schemes involving Partners entities, such as the Osher Center for Complementary and Integrative Medical Therapies and, even under my own roof (I shudder as I write this), a Reiki Workshop. Nevertheless, it’s telling, I hope, that not only does the Marino Center fail to appear under any list of Partners affiliates, Community Health Partnerships, Wellness, Prevention, or any other conceivable category, but it fails to yield a single ‘hit’ when entered as a search term on the Partners website (the term ‘integrative’ yields seven hits, but none appears to be about ‘CAM,’ except possibly for an RSS feed that I’ve no patience to peruse. Is it possible that Partners is embarrassed by the Osher Center? I hope that, too).

I’ve previously asserted that the NWH is not affiliated with the Marino Center, other than that some Marino Center physicians have been—against my judgment, not that I was consulted—granted hospital staff privileges. I made this assertion in my original Bravewell post a couple of weeks ago, after having questioned the NWH Chief Medical Officer, Dr. Les Selbovitz, who verified it; nothing on the NWH website suggests otherwise.

I’ve no reason to doubt the Marino Center’s third bullet above, “makes referrals to Mass General Hospital,” etc., but this is something that any physician can do, regardless of affiliation. I suspect that if there were an ‘integrative hospital‘ in Boston, reason forbid, the Marino Center would make referrals to it.

False and Misleading Information about ‘Services’

Let’s get to the meat of the problem.

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Posted in: Acupuncture, Homeopathy, Medical Ethics, Science and Medicine, Science and the Media

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Informed Consent and CAM: Truth Not Optional

In three recent posts, Drs. Novella, Gorski and Atwood took the Bravewell Collaborative to task over a report on its recent survey of U.S. “integrative medicine” centers. As Dr. Novella noted,

So what is integrative medicine? When you strip away the rebranding and co-opting of features and treatments of mainstream medicine, you are left with the usual list of pseudoscientific practices that have been trying to insert themselves into mainstream medicine for decades through a series of marketing and propaganda strategies. Bravewell has positioned itself at the forefront of that effort.

Among these pseudoscientific practices listed in a chart from the report included by Dr. Gorski in his post were acupuncture, TCM, reiki, therapeutic touch, naturopathy, homeopathy and reflexology.
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Posted in: Acupuncture, Chiropractic, Energy Medicine, Homeopathy, Legal, Medical Ethics, Naturopathy, Science and Medicine

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What is Science?

Consider these statements:

…there is an evidence base for biofield therapies. (citing the Cochrane Review of Touch Therapies)

The larger issue is what constitutes “pseudoscience” and what information is worthy of dissemination to the public. Should the data from our well conducted, rigorous, randomized controlled trial [of 'biofield healing'] be dismissed because the mechanisms are unknown or because some scientists do not believe in the specific therapy?…Premature rejection of findings from rigorous randomized controlled trials are as big a threat to science as the continuation of falsehoods based on belief. Thus, as clinicians and scientists, our highest duty to patients should be to investigate promising solutions with high benefit/risk ratios, not to act as gatekeepers of information based on personal opinion.

–Jain et al, quoted here

Touch therapies may have a modest effect in pain relief. More studies on HT and Reiki in relieving pain are needed. More studies including children are also required to evaluate the effect of touch on children.

Touch Therapies are so-called as it is believed that the practitioners have touched the clients’ energy field.

It is believed this effect occurs by exerting energy to restore, energize, and balance the energy field disturbances using hands-on or hands-off techniques (Eden 1993). The underlying concept is that sickness and disease arise from imbalances in the vital energy field. However, the existence of the energy field of the human body has not been proven scientifically and thus the effect of such therapies, which are believed to exert an effect on one’s energy field, is controversial and lies in doubt.

—Cochrane Review of Touch Therapies, quoted here

 …

Science is advanced by an open mind that seeks knowledge, while acknowledging its current limits. Science does not make assertions about what cannot be true, simply because evidence that it is true has not yet been generated. Science does not mistake absence of evidence for evidence of absence. Science itself is fluid.

—David Katz

When people became interested in alternative medicines, they asked me to help out at Harvard Medical School. I realized that in order to survive there, one had to become a scientist. So I became a scientist.

—Ted Kaptchuk, quoted here.

 …It seems that the decision concerning acceptance of evidence (either in medicine or religion) ultimately reflects the beliefs of the person that exist before all arguments and observation.

 —Ted Kaptchuk, quoted here.

Together they betray a misunderstanding of science that is common not only to “CAM” apologists, but to many academic medical researchers. Let me explain. (more…)

Posted in: Basic Science, Book & movie reviews, Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Homeopathy, Medical Academia, Science and Medicine

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Homeopathy and Its Kindred Delusions

Note: The James Randi Educational Foundation (JREF) is publishing a new series of e-books.  The first two offerings are an excellent new book on critical thinking by Bob Carroll, Unnatural Acts, and the first in a planned series of republications of classic skeptical works, Homeopathy and Its Kindred Delusions, by Oliver Wendell Holmes. I was asked to write the introduction for the latter, and the JREF has kindly given their permission for me to reproduce it here.

————–

The German philosopher Hegel said, “We learn from history that we don’t learn from history.” “Homeopathy and Its Kindred Delusions” is a remarkable little book based on two lectures Oliver Wendell Holmes gave in 1842. It is a masterful debunking of homeopathy. If his lessons had been taken to heart, homeopathy would not have survived and we could have avoided a great number of other medical delusions that continue to plague us today, both from charlatans and from well-meaning advocates who lack Holmes’ critical thinking skills.

To realize just how remarkable this book is, imagine the world of 1842.  Samuel Hahnemann, the inventor of homeopathy, was still alive. Roentgen wouldn’t discover x-rays until 1895. The germ theory was not yet established. Semmelweis wouldn’t make his observations on puerperal fever until 3 years later. It wasn’t until 1854 that John Snow removed the Broad Street pump handle and stopped a cholera epidemic. Koch’s postulates for determining infectious causes of disease weren’t published until 1890. Doctors didn’t wash their hands or use sterile precautions for surgery. Bloodletting to “balance the humors“ was still a common practice. The randomized placebo-controlled trial wouldn’t appear for another century. Contemporary medicine often did more harm than good. In fact, Holmes himself famously quipped “I firmly believe that if the whole materia medica could be sunk to the bottom of the sea, it would be all the better for mankind and all the worse for the fishes.” (more…)

Posted in: History, Homeopathy

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Pediatrics & “CAM” II: just wrong

In November, the journal Pediatrics published an entire supplement devoted to Pediatric Use of Complementary and Alternative Medicine: Legal, Ethical and Clinical Issues in Decision-Making. The authors purport to have “examined current legal, ethical, and clinical issues that arise when considering CAM use for children and identified where gaps remain in law and policy.” (S150) Their aim is to “illustrate the relevance and impact of identified [ethical, legal and clinical] guidelines and principles,” to recommend responses, identify issues needing further consideration, and thus “assist decision makers and act as a catalyst for policy development.” (S153)

Unfortunately, as we saw in Pediatrics & “CAM” I: the wrong solution, the authors’ solution for the “issues that arise when considering CAM use for children” consist, in the main, of placing a huge burden on the practicing physician to be knowledgeable about CAM, keep up with CAM research, educate patients about CAM, warn patients about CAM dangers, refer to CAM practitioners, ensure that CAM practitioners are properly educated, trained and credentialed, and so on.

Limit CAM? Not happening

Curiously absent are recommendations placing responsibility on those who profit from the sale of CAM products and services — the dietary supplement manufacturers, homeopaths, acupuncturists, and the like — whose actions are directly responsible for the deleterious effects on patients’ health detailed in the supplement articles and described in the earlier post.

Apparently the authors’ view is that there is no accommodation to CAM too onerous to ask the practicing physician or the patient to bear. Even though they plainly locate the problems they describe — a missed diagnosis, ineffective treatments, drug therapy interactions, poor advice — in the CAM services and products themselves, suggesting that these services and products be limited or eliminated never seems to cross their minds.

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Posted in: Acupuncture, Chiropractic, Herbs & Supplements, Homeopathy, Legal, Medical Ethics, Politics and Regulation, Vaccines

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Pediatrics & “CAM” I: the wrong solution

Oh no!  Not again! The venerable medical journal Pediatrics devotes an entire supplement this month to Pediatric Use of Complementary and Alternative Medicine: Legal, Ethical, and Clinical Issues in Decision-Making.

We sense from the very first sentence that we are in familiar territory:

Rapid increases the use of complementary and alternative medicine (CAM) raise important legal, ethical, clinical, and policy issues. (S150)

“Rapid increases”? And evidence of these “rapid increases?” None cited.

We do, however, see the same shopworn reference to popularity deconstructed elsewhere on SBM. What we learned by actually examining “the large 2007 US survey” which purportedly “revealed that ~4 in 10 adults and 1 in 9 children and youth used CAM products or therapies within the previous year”(S150) is that

…most hard-core CAM modalities are used by a very small percentage of the population. Most are less than five percent. Only massage and manipulation are greater than 10 percent. These numbers are also not significantly different from 10 or 20 years ago — belying the claim that CAM use is increasing.

We also find this definition of “CAM”:

a broad domain of healing resources …other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period. (S150)

I’m not sure what it takes to become “intrinsic” to the “politically dominant” healthcare system. If it includes being legal, licensed or covered by public and/or private insurance, that would appear to disqualify dietary supplements, chiropractic, acupuncture, homeopathy, homeopathic products and naturopathy as “CAM” in some, or in some cases all, of the American states.

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Posted in: Acupuncture, Chiropractic, Herbs & Supplements, Homeopathy, Legal, Medical Ethics, Naturopathy, Politics and Regulation, Science and Medicine, Vaccines

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Defining what a “physician” is

The very concepts of “complementary and alternative medicine” (CAM) and “integrative medicine” (IM), the former of which “complements” science-based medicine with quackery and the latter of which “integrates” pseudoscience-based with science-based medicine are all about slapping a veneer of scientific legitimacy onto something that has failed to achieve such legitimacy through actual basic, translational, and clinical science. The reason I start out by saying this is to emphasize that CAM/IM is all about using language to persuade that pseudoscience is actually science-based. It’s far more about marketing than accurately communicating concepts. In CAM, everything is “holistic,” and doctors “care for the whole patient,” while “Western medicine” is “reductionistic” and “allopathic.” At the very heart of this language is a false dichotomy: That you must either embrace pseudoscience or that you somehow can’t provide care as compassionate and caring as what the quacks supposedly provide, nor are you able to provide for the emotional needs of your patients. There are two false dichotomies, actually, in that there is also the not-so-subtle implication in CAM that you can’t be truly “holistic” without—you guessed it—embracing the pseudoscience that is at the heart of many CAM/IM modalities.

This use and abuse of language for propagandistic purposes in CAM/IM is not limited to just these examples. In fact, the misuse of language infuses the whole enterprise of CAM/IM to the point that its adherents, not content with being mere “practitioners,” are trying to claim the very title of “physician” for themselves. I learned this from John Weeks, the main force behind the Integrator Blog, a blog dedicated to issues of CAM and IM. He’s the one who first let me know about Andrew Weil’s attempt to put together a board certification in IM. In particular, his reporting on the reaction of CAM/IM practitioners, both physicians and non-physicians, to this initiative by Andrew Weil was most illuminating to me. What was most telling was how further propagandistic use of the language focused on “dominance” by MDs, which in this case struck me as actually being closer to the truth than the usual CAM-speak is. In any case, Dr. Weil’s initiative does indeed appear to be more about taking control of CAM for physicians, his high-minded language about “establishing standards” notwithstanding.

This time around, Weeks has provided me with an education about how alternative/CAM/integrative practitioners now covet the title of “physician”. In the process, he also uses and abuses language in the same way that Andrew Weil and CAM/IM advocates do. This time around, it’s all about co-opting the title of “physician” for non-physician CAM practitioners. It’s bad enough to me when actual physicians are seduced by the pseudoscience of CAM, but this effort appears to be an intentional strategy designed to confuse the public by proclaiming as physicians practitioners who lack the essential skills to be a physician, such as acupuncturists, chiropractors, homeopaths, and naturopaths.
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Posted in: Chiropractic, Homeopathy, Naturopathy, Politics and Regulation

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Dummy Medicine, Dummy Doctors, and a Dummy Degree, Part 2.2: Harvard Medical School and the Curious Case of Ted Kaptchuk, OMD (cont. again)

“Strong Medicine”: Ted Kaptchuk and the Powerful Placebo

At the beginning of the first edition of The Web that has no Weaver, published in 1983, author Ted Kaptchuk portended his eventual academic interest in the placebo:

A story is told in China about a peasant who had worked as a maintenance man in a newly established Western missionary hospital. When he retired to his remote home village, he took with him some hypodermic needles and lots of antibiotics. He put up a shingle, and whenever someone came to him with a fever, he injected the patient with the wonder drugs. A remarkable percentage of these people got well, despite the fact that this practitioner of Western medicine knew next to nothing about what he was doing. In the West today, much of what passes for Chinese medicine is not very different from the so-called Western medicine practiced by this Chinese peasant. Out of a complex medical system, only the bare essentials of acupuncture technique have reached the West. Patients often get well from such treatment because acupuncture, like Western antibiotics, is strong medicine.

Other than to wonder if Kaptchuk had watched too many cowboy ‘n’ Native American movies as a kid, when I first read that passage I barely blinked. Although the Chinese peasant may have occasionally treated someone infected with a bacterium susceptible to his antibiotic, most people will get well no matter what you do, because most illnesses are self-limited. Most people feel better even sooner if they think that someone with special expertise is taking care of them. If you want to call those phenomena the “placebo effect,” in the colloquial sense of the term, fine. That, I supposed, was what Kaptchuk meant by “strong medicine.”

Turns out I was mistaken. Let’s briefly follow Kaptchuk’s career path after 1983. In the 2000 edition of The Web, he wrote:

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Posted in: Acupuncture, Basic Science, Book & movie reviews, Chiropractic, Clinical Trials, Homeopathy, Medical Academia, Science and Medicine

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Homeopathy and Plausibility

The fundamental concept of science-based medicine (SBM) is that medical practice should be based upon the best available science. This may seem obvious, but there are many important details to its application, such as the relationship between clinical and basic science. Clinical claims require clinical evidence, but clinical evidence can be tricky and is often preliminary. It is therefore helpful (I would say essential) to view the clinical evidence in light of all of the rest of science.

A thorough basic and clinical science analysis of a medical claim can be summarized by the term “plausibility,” or “prior probability” if you want to put it into statistical terms. When we say a certain belief is plausible we mean it is consistent with what we know from the rest of science. In other words, because of the many weaknesses of clinical evidence, in order for a therapy to be generally accepted as part of SBM it should have a certain minimal supporting clinical evidence and overall scientific plausibility.

These can exist in different proportions – for example one therapy may be highly plausible (it would be shocking if it were not true) and have modest supporting clinical evidence, while another may have unknown plausibility but with solid clinical evidence of efficacy. But no therapy should have clinical evidence that suggests lack of efficacy, nor extreme implausibility (not just an unknown mechanism, but no possible mechanism).

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