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Of SBM and EBM Redux. Part II: Is it a Good Idea to test Highly Implausible Health Claims?

Review

This is the second post in a series* prompted by an essay by statistician Stephen Simon, who argued that Evidence-Based Medicine (EBM) is not lacking in the ways that we at Science-Based Medicine have argued. David Gorski responded here, and Prof. Simon responded to Dr. Gorski here. Between that response and the comments following Dr. Gorski’s post it became clear to me that a new round of discussion would be worth the effort.

Part I of this series provided ample evidence for EBM’s “scientific blind spot”: the EBM Levels of Evidence scheme and EBM’s most conspicuous exponents consistently fail to consider all of the evidence relevant to efficacy claims, choosing instead to rely almost exclusively on randomized, controlled trials (RCTs). The several quoted Cochrane abstracts, regarding homeopathy and Laetrile, suggest that in the EBM lexicon, “evidence” and “RCTs” are almost synonymous. Yet basic science or preliminary clinical studies provide evidence sufficient to refute some health claims (e.g., homeopathy and Laetrile), particularly those emanating from the social movement known by the euphemism “CAM.”

It’s remarkable to consider just how unremarkable that last sentence ought to be. EBM’s founders understood the proper role of the rigorous clinical trial: to be the final arbiter of any claim that had already demonstrated promise by all other criteria—basic science, animal studies, legitimate case series, small controlled trials, “expert opinion,” whatever (but not inexpert opinion). EBM’s founders knew that such pieces of evidence, promising though they may be, are insufficient because they “routinely lead to false positive conclusions about efficacy.” They must have assumed, even if they felt no need to articulate it, that claims lacking such promise were not part of the discussion. Nevertheless, the obvious point was somehow lost in the subsequent formalization of EBM methods, and seems to have been entirely forgotten just when it ought to have resurfaced: during the conception of the Center for Evidence-Based Medicine’s Introduction to Evidence-Based Complementary Medicine.

Thus, in 2000, the American Heart Journal (AHJ) could publish an unchallenged editorial arguing that Na2EDTA chelation “therapy” could not be ruled out as efficacious for atherosclerotic cardiovascular disease because it hadn’t yet been subjected to any large RCTs—never mind that there had been several small ones, and abundant additional evidence from basic science, case studies, and legal documents, all demonstrating that the treatment is both useless and dangerous. The well-powered RCT had somehow been transformed, for practical purposes, from the final arbiter of efficacy to the only arbiter. If preliminary evidence was no longer to have practical consequences, why bother with it at all? This was surely an example of what Prof. Simon calls “Poorly Implemented Evidence Based Medicine,” but one that was also implemented by the very EBM experts who ought to have recognized the fallacy.

There will be more evidence for these assertions as we proceed, but the main thrust of Part II is to begin to respond to this statement from Prof. Simon: “There is some societal value in testing therapies that are in wide use, even though there is no scientifically valid reason to believe that those therapies work.”

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Posted in: Chiropractic, Clinical Trials, Energy Medicine, Health Fraud, History, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Politics and Regulation, Science and Medicine

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How low can Oprah Winfrey go? Promoting faith healer John of God to the masses

Several of the bloggers on Science-Based Medicine have been — shall we say? — rather critical of Oprah Winfrey. The reason, of course, is quite obvious. Oprah is so famous that if you mention her first name nearly everyone will know exactly of whom you speak. For the last quarter century, her daytime TV talk show has been a ratings juggernaut, leading to the building of a media behemoth and making Oprah one of the richest and most famous women in the world. Unfortunately, part of Oprah’s equation for success has involved the promotion of quackery and New Age woo, so much so that last year I lamented about the Oprah-fication of medicine, which scored me a writing gig in the Toronto Star. Whether it be promoting bio-identical hormones, The Secret (complete with a testimonial from someone who used The Secret to persuade herself not to pursue conventional therapy for breast cancer), Suzanne Somers, the highly dubious medicine promoted by Dr. Christiane Northrup, or foisting reiki aficionado Dr. Mehmet Oz or anti-vaccine “mother warrior” Jenny McCarthy onto a breathless public, arguably no one is a more powerful force for the promotion of pseudoscience in America, if not the world. Truly, the ending of Oprah’s TV show in the spring is a very good thing indeed for science and rationality. Or it would be, were it not for the fact that the reason Oprah is wrapping up her show after a quarter of a century is to start up her own cable channel, so that we can have Oprah-branded and -inspired programming 24/7.

The mind boggles.

Still, my dislike for how Oprah promotes New Age mysticism and pseudoscience on a distressingly regular basis aside, I actually did think there were limits to how low she would go. I actually thought there were limits to how egregiously vile a quackery Oprah would endorse. The operative word, of course, is “did,” which now needs to be struck off after last Wednesday, which is when Oprah did an entire show entitled Do You Believe in Miracles? (Guess what answer was implicitly, if not explicitly, endorsed.) Featured prominently in that episode were several segments on the faith healer John of God.
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Posted in: Energy Medicine, Health Fraud, Religion, Science and the Media

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Energy Bracelets: Embedding Frequencies in Holograms for Fun and Profit

A salesman is demonstrating a new product at a sports store in the local mall. He has a customer stand with his arms extended horizontally to the sides; he presses down on an arm and the customer starts to fall over. Then he puts a bracelet on the customer and repeats the test; this time he is apparently unable to make the customer lose his balance. He has the customer turn his head as far as he can without the bracelet, and shows that he can turn his head a few degrees more after he puts on the bracelet. (Try this yourself: if you turn your head, wait a couple of seconds and try again, you will always be able to turn it further on the second trial). He similarly shows that the customer is stronger when he wears the bracelet. The customer and the onlookers are mightily impressed by the demonstration, by the salesman’s testimonials, and by the endorsements of famous athletes: they buy the bracelets to improve their athletic performance.

These so-called energy bracelets (also pendants and cards) allegedly contain a hologram embedded with frequencies that react positively with your body’s energy field to improve your balance, strength, flexibility, energy, and sports performance; and they also offer all sorts of other benefits (such as helping horses and birds and relieving menstrual cramps and headaches). The claims and the language on their websites are so blatantly pseudoscientific it’s hard to believe anyone would fall for them. Here are just a few examples from the Power Balance website:

  • We react with frequency because we are a frequency.
  • Your body’s energy field likes things that are good for it.
  • Why Holograms? We use holograms because they are composed of Mylar—a polyester film used for imprinting music, movies, pictures, and other data. Thus, it was a natural fit.
  • A primitive form of this technology was discovered when someone, somewhere along the line, picked up a rock and felt something that reacted positively with his body.

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Posted in: Energy Medicine

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Uff Da! The Mayo Clinic Shills for Snake Oil

A couple of weeks ago, in a review of the Mayo Clinic Book of Home Remedies, Harriet Hall expressed relief that she hadn’t found any “questionable recommendations for complementary & alternative medicine (CAM) treatments” in that book:

Since “quackademic” medicine is infiltrating our best institutions and organizations, I wasn’t sure I could trust even the prestigious Mayo Clinic.

The Home Remedies book may be free of woo, but Dr. Hall was right to wonder if she could trust the Mayo Clinic. About a year ago I was asked to comment on an article in the American Journal of Hematology (AJH), in which investigators from the Mayo Clinic reported that among a cohort of lymphoma patients who were “CAM” users,

There was a general lack of knowledge about forms of CAM, and about potential risks associated with specific types of CAM…

This suggests the need to improve access to evidence-based information regarding CAM to all patients with lymphoma.

No surprise, that, but I couldn’t help calling attention to the paradox of one hand of the Mayo Clinic having issued that report even as the other was contributing to such ignorance:

The Mayo Clinic Book of Alternative Medicine details dozens of natural therapies that have worked safely for many patients in treating 20 top health issues. You may be surprised that Mayo Clinic now urges you and your doctor to consider yoga, garlic, acupuncture, dietary supplements and other natural therapies. Yet the record is clear. Many of these alternative therapies can help you achieve reduced arthritis pain, healthier coronary arteries, improved diabetes management, better memory function and more.

Mayo Clinic cover

Nor could such a paradox be explained by the right hand not having known what the left was doing: Brent Bauer, MD, the Director of the Mayo Clinic Complementary and Integrative Medicine Program, is both the medical editor of the Book of Alternative Medicine (MCBAM) and a co-author of the article in the AJH.

As chance would have it, I had picked up a copy of the latest (2011) edition of the MCBAM only a couple of days before Dr. Hall’s post. Does it live up to its promises? Do its “straight answers from the world’s leading medical experts” respond to “the need to improve access to evidence-based information regarding CAM?” Let’s find out. In some cases I’ll state the implied questions and provide the straight answers.

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Posted in: Acupuncture, Book & movie reviews, Chiropractic, Energy Medicine, Health Fraud, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Science and Medicine, Science and the Media

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Reflexology. Insert Nancy Sinatra Reference Here.

In the last post on acupuncture, I noted that the University of Maryland offered reflexology along with other supplements, and complementary and alternative medicine (SCAMs). I was uncertain as to the particulars of this SCAM, and this post is a result of those investigations.

Although messy in reality, science is a tool that gives us an idea as to how the real world functions. People will observe some aspect of nature, often for a lifetime, and from those observations discover a pattern in the data. Tycho Brahe spent a life carefully measuring the orbits of the planets; the data was used later by Kepler to determine that the planets orbit in an ellipse with the sun at one of the foci. If you have knowledge of the history of science, you realize what an amazing feat this represents, both in the measurement of the orbits and the analysis of the data. Careful observation, analysis of the data, then conclusions.

This is in contrast to SCAMs, where so many of the interventions are discovered by revelation, and then developed independently of data and observation. Palmer and chiropractic, von Peczely and iridology, Usui and reiki are examples. These geniuses discovered aspects of existence unseen by anyone before or after.

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Posted in: Energy Medicine, Science and Medicine

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Eric Pearl “Reconnects” with Hands-Off Healing

I first became aware of chiropractor Eric Pearl through the reprehensible movie The Living Matrix. Several months ago I reviewed that movie and described its segment featuring Pearl as follows:

A 5 year old with cerebral palsy was allegedly healed by “reconnective healing” by a chiropractor who is shown waving his hands a few inches away from the child’s body. Problem: There was no medical evaluation before and after to determine whether anything had objectively changed, and video of the child after treatment shows that his gait is not normal.

I have since learned that Pearl is far more than an eccentric oddball. He is a whole industry. He is teaching his “reconnective healing” methods to others worldwide through seminars in several languages, he engages in aggressive marketing, he offers practice-building advice to his many disciples, and he even foists his beliefs on groups of impressionable young children. I use the word disciples intentionally because there are strong religious overtones to this healing method. 

What is Reconnective Healing? 

“The Reconnection” is similar to therapeutic touch, but goes much farther. He does not need to physically touch patients because they can feel his touch without any contact. They close their eyes and he moves his hands around their bodies but several inches away. They feel a presence, see colors unknown on Earth, and often see angels (one particular angel is George, a multicolored parrot). Afterwards, they report miraculous healings of “cancers, AIDS-related diseases, epilepsy, chronic fatigue syndrome, multiple sclerosis, rheumatoid and osteoarthritis, birth disfigurements, cerebral palsy and other serious afflictions.” (more…)

Posted in: Energy Medicine

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The Living Matrix: A Movie Promoting Energy Medicine Beliefs

It’s boring to try to ferret out reliable health information from dry medical journals. It’s easier and more fun to watch a movie. A new movie promises to change the way you think about your health. To bring you breakthroughs that will transform your understanding of how to get well and stay well. To share the discoveries of leading researchers and health practitioners about miracle cures that traditional medicine can’t explain.

If this makes your baloney detector light up, good for you!

The Living Matrix: A Film on the New Science of Healing is an atrociously bad movie that falls squarely in the tradition of What the Bleep Do We Know? In his book Nonsense on Stilts, Massimo Pigliucci characterized the “Bleep” movie as “one of the most spectacular examples of a horribly tangled mess of science and nonsense,” and this new movie is more of the same. Bleep was just silly, but The Living Matrix is potentially dangerous because it might persuade patients to make poor decisions about their medical care. (more…)

Posted in: Energy Medicine

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No Education? No Training? No License? No Problem!

When Daniel David Palmer, the inventor of chiropractic, and his acolytes first took up the practice of chiropractic, around the turn of the last century, they were jailed for the unlicensed practice of medicine. If history had left them there, we might not be fighting a continuing battle with the pseudoscience that is “alternative” medicine today.

Unfortunately, the Kansas legislature intervened on the chiropractors’ behalf and passed the first chiropractic practice act in 1913. Over the years, state by state, the notions that subluxations interfere with nerve flow, causing ill health, and that only chiropractors could “correct” these subluxations, thereby restoring health, were incorporated into state law. As well, chiropractors were given a broad scope of practice and allowed to call themselves “doctor.” In 1974, Louisiana’s passage of a chiropractic practice act made chiropractic legal in all 50 states.

Acupuncturists and naturopaths copied this successful formula by convincing state legislatures to incorporate their pseudoscientific ideas directly into practice acts, thereby managing to become licensed health care providers. Legislative fiat triumphed over scientific facts time after time.

Laws allowing the practice of “alternative” medicine did not totally eliminate resistance to pseudoscientific practices from some quarters. Insurance companies, for example, refused to pay for treatments they considered experimental. Medicare did not cover chiropractic. Labs and x-ray facilities wouldn’t allow use of their services. But for each roadblock science tried to put in the way, state and federal legislators were there to remove it, paving the way toward “acceptance.”
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Posted in: Acupuncture, Energy Medicine, Herbs & Supplements, Homeopathy, Politics and Regulation

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Mainstream Media’s Sub-Par Health Coverage, Part 2

I recently wrote about an experience that I had with a reporter (Erica Mitrano) who interviewed me about energy healing at Calvert Memorial Hospital in southern Maryland. Erica was very friendly and inquisitive, and we had a nice conversation about the lack of scientific evidence supporting any energy healing modality. I thought it would be fun to post what we had discussed at SBM, and then wait to see what trickled down into the finished piece.

When the final article appeared I was very disappointed. Not only was I not quoted, but there was no skeptical counter-point at all. The story read like an unquestioning endorsement of junk science, and I wondered if it was worth it to continue speaking to journalists to offer expert advice. It seemed to me that this experience was emblematic of all that’s wrong with health reporting these days. (Just ask Gary Schwitzer – who has recently given up on reviewing TV health stories in mainstream media since they are generally so inaccurate.) (more…)

Posted in: Energy Medicine, Science and the Media

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The 2nd Yale Research Symposium on Complementary and Integrative Medicine. Part II

The Main Event: Novella vs. Katz

The remainder of the Symposium comprised two panels. The first was what I had come to see: a Moderated Discussion on Evidence and Plausibility in the Context of CAM Research and Clinical Practice, featuring our Founder, Steve Novella, who is also Assistant Professor of Neurology at Yale; and David Katz, the speaker who had borne the brunt of the criticism after the 2008 conference (as I wrote in Part I). According to the Symposium syllabus, he is:

David L. Katz, MD, MPH, FACPM, FACP, an internationally renowned authority on nutrition, weight management, and the prevention of chronic disease, and an internationally recognized leader in integrative medicine and patient-centered care. He is a board certified specialist in both Internal Medicine, and Preventive Medicine/Public Health, and Associate Professor (adjunct) in Public Health Practice at the Yale University School of Medicine. Katz is the Director and founder (1998) of Yale University’s Prevention Research Center; Director and founder of the Integrative Medicine Center at Griffin Hospital (2000) in Derby, CT; founder and president of the non-profit Turn the Tide Foundation; and formerly the Director of Medical Studies in Public Health at the Yale School of Medicine for eight years. He currently serves as Chair of the Connecticut Chapter of the Partnership to Fight Chronic Disease and represents Yale University on the Steering Committee of the Consortium of Academic Health Centers for Integrative Medicine.

The syllabus had excerpted that statement from a much larger, remarkable document, which I urge you to review.

I will attempt to report the Moderated Discussion as neutrally as possible, as though I were a disinterested journalist (don’t worry: later I’ll rail).

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Posted in: Energy Medicine, Medical Academia, Medical Ethics, Science and Medicine, Science and the Media

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