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Dr. Oz and John Edward: Just when I thought Dr. Oz couldn’t go any lower, he proves me wrong

I’ve really come to detest Dr. Mehmet Oz.

You remember Dr. Mehmet Oz, don’t you? How can you escape him? He is, after all, Oprah Winfrey’s protege, and of late he’s really been living up (or down) to the example set by his television mentor, who of late apparently thinks nothing of promoting faith healing quack John of God on her show. Following in the footsteps of his much more famous and well-known mentor, this season on his television show, The Dr. Oz Show, Dr. Oz has in some ways imitated Oprah and in some ways gone her one better (one worse, really) in promoting the Oprah-fication of medicine. And this season has been a particularly bad one for science-based medicine on The Dr. Oz Show. Apparently Dr. Oz felt that he had to surpass what he did last season, which included inviting a man whom I consider to be one of the foremost sellers of quackery on the Internet, Dr. Joseph Mercola. Prior to that, Dr. Oz had done an episode touting the glories of that form of faith healing known as reiki. In between, he made appearances at various panels of woo-friendly physicians trying to coopt President Obama’s health insurance reform initiative to cover more “holistic” care (i.e., “integrative medicine”).

In the next season, in particular over the last couple of months, Dr. Oz showed me just how wrong I had been when I had previously been saying that Dr. Oz seemed to be mostly science-based but with a soft spot for certain kinds of pseudoscience. This season, Dr. Oz has thrown down the gauntlet to science-based medicine (SBM) and, as I like to put it, crossed the Woo-bicon. First, he not only invited Joe Mercola back on his show, but he did it defiantly, defending Mercola against what I consider to be much-deserved charges of being a seller of quackery and lauding him as a “pioneer of holistic treatments.” A couple of weeks later, Dr. Oz pulled the classic “bait and switch” of alternative medicine, featuring a yoga instructor on his show who also advocated all sorts of Ayruvedic quackery. Then, a mere few days later Dr. Oz, apparently not satisfied at his transformation from nominally science-based to being based solely on whatever would bring him higher ratings, completed his journey to the Dark Side of quackery by credulously featuring a faith healer on his show and hosting what has to be the lamest faith healing that I’ve ever seen in my entire life. After that, I didn’t think Dr. Oz could go much lower, although he tried, two examples of which were his anti-vaccine-sympathetic episode on autism in which he featured Dr. Robert Sears and his utterly reversing a previous scientifically correct stance of his and promoting a dubious and potentially dangerous diet.
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Posted in: Health Fraud, Religion, Science and the Media

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Mothering magazine: Peddling dangerous health misinformation to new mothers

Last week, the British Medical Journal (BMJ) published an expose by investigative journalist Brian Deer that enumerated in detail the specifics of how a British gastroenterologist turned hero of the anti-vaccine movement had committed scientific fraud by falsifying key aspects of case reports that he used as the basis of his now infamous 1998 Lancet article suggesting a link between the MMR vaccine and a syndrome consisting of regressive autism and enterocolitis. Indeed, Deer even went so far as to describe Wakefield’s fraud as “Piltdown medicine,” comparing it explicitly to the infamous “Piltdown man” hoax, and in an accompanying editorial the editors of the BMJ agreed. These revelations were not by any means new. Scientists had suspected that something wasn’t quite right about Wakefield’s work almost as soon as it had been published, and by 2004 Brian Deer had uncovered clear evidence of major undisclosed conflicts of interest on Wakefield’s part. Unfortunately, by that time the proverbial cat was out of the proverbial bag, and Wakefield’s fraudulent research, aided and abetted by his flair for self-promotion in the media and some truly execrable, credulous, and sensationalistic coverage by the British press, had ignited a major scare over the MMR vaccine. MMR uptake rates plummeted below levels necessary for herd immunity, and measles came roaring back with a vengeance in the U.K. By the time the British General Medical Council finally ruled about a year ago that Wakefield had committed research fraud and violated research ethics in the work reported in his 1998 Lancet article and recommended that he be “struck off” (i.e., have his license to practice medicine in the U.K. revoked), the damage had been done.

As important as Wakefield is to the genesis of the modern anti-vaccine movement, however, there is another force that acts far more “where the rubber hits the road,” so to speak. This force comes in the form of publications and online discussion forums that cater to new mothers, offering all manner of advice and support. Some of these are very good, but all too many of them are hotbeds of anti-vaccine pseudoscience, confidently proclaimed by “elder statesman” members of these forums and included in articles published in glossy, attractive magazines. As a rather ironic coincidence, just as news of Andrew Wakefield’s latest humiliation was finding its way out into multiple news outlets last week, the first issue of 2011 of just such a glossy publication hit the shelves. I’m referring to Mothering, whose tagline is “Inspiring Natural Families Since 1976.” In reality, it should read: “Inspiring quackery and anti-vaccine views since 1976.” Of course, in the world of “alt-med,” the two often go hand-in-hand. In any case, one of our readers sent me a link to the latest issue of Mothering. Unfortunately, I can’t supply you with that link, because it’s for subscribers. I will, however, describe and quote articles and passages that demonstrate just what a wretched hive of scum and quackery Mothering is, particularly with respect to vaccines but not limited to vaccines. Taking into account its large and vigorous online forums, Mothering is major force for the promotion of anti-vaccine views and quackery among new mothers.
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Posted in: Health Fraud, Homeopathy, Science and the Media, Vaccines

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“Piltdown medicine” and Andrew Wakefield’s MMR vaccine fraud

Pity poor Andrew Wakefield. Well, not really. I tend to view what’s happening to him yet again as the chickens coming home to roost.

Let’s put it this way. 2010 was a terrible year for him, and 2011 is starting out almost as bad. In February 2010, the General Medical Council in the U.K. recommended that Wakefield be stripped of his license to practice medicine in the U.K. because of scientific misconduct related to his infamous 1998 case series published in The Lancet, even going so far as to refer to him as irresponsible and dishonest, and in May 2010 he was. This case series, thanks to Wakefield’s scientific incompetence and fraud, coupled with his flair for self-promotion and enabled by the sensationalistic credulity of the British press, ignited a scare about the measles-mumps-rubella (MMR) vaccine in which, afraid that the MMR vaccine causes autism, parents in the U.K. eschewed vaccinating their children in droves. As a result, vaccination rates plummeted far below the level necessary for herd immunity, with the entirely predictable result of massive measles outbreaks in the U.K. Measles, which as of the mid-1990s had been declared under control by British and European health authorities, came roaring back to the point where in 2008 it was declared once again endemic in the British Isles. In a mere decade and a half, several decades of progress in controlling this scourge had been unravelled like a thread hanging off a cheap dress, all thanks to Andrew Wakefield and scandal mongers in the British press.

True, Wakefield had long since moved to Texas, the better to be the founding “scientific director” of a house of autism woo known as Thoughtful House. Thus, the removal of his license to practice had little practical import (or effect on his ability to earn a living), or so it seemed at the time, given that Wakefield did not treat patients and hauled in quite the hefty salary for his promotion of anti-vaccine pseudoscience. Fortunately, karma’s a bitch, and, as a result of the GMC’s action, in short order The Lancet retracted Wakefield’s 1998 paper; Wakefield was pushed out of Thoughtful House; and his latest attempt to “prove” that vaccines cause autism in an animal study was also retracted. Investigative reporter Brian Deer’s investigation finding that Andrew Wakefield had committed scientific fraud in carrying out his Lancet study joined prior findings that Wakefield had been in the pocket of trial lawyers (to the tune of £435 643, plus expenses) seeking to sue the vaccine industry at the time he carried out his “research” and the allegations by renowned PCR expert Stephen Bustin during the Autism Omnibus as to how shoddily Wakefield’s other research was carried out. Finally, the mainstream media started to back away from its previous embrace of Wakefield and his claims. As a result, for a while at least, Wakefield was reduced to lame appearances at sparsely attended anti-vaccine rallies last spring.
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Posted in: Health Fraud, Neuroscience/Mental Health, Vaccines

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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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Death by “alternative” medicine: Who’s to blame? (Revisited)

(NOTE: There is now an addendum to this post.)

(NOTE #2: The videos of Robert O. Young’s interview with Kim Tinkham have been removed, as I predicted in this post that they would be. Fortunately, I downloaded copies before he managed to do that. Part 6 appears to be still there–for now.)

(NOTE #3: It was announced on the Facebook page Caring for Kim that the subject of this post, Kim Tinkham, passed away on December 7, 2010 in the late afternoon. Although it was not revealed what kind of cancer she died of, Tinkham almost certainly died from metastatic breast cancer. Quackery appears to have claimed another victim.)

I hate stories like this. I really do. I hate them with a burning passion that makes it hard for me to see straight when I first find out about them.

In fact, you might even say that stories like this are a major part of the reason why I do what I do, both here and elsewhere. They’re a major part of the reason why I’ve recently branched out into public speaking, something that used to terrify me beyond belief but that lately I’ve become at least competent at–sometimes even not bad at all. Sadly, the story I’m about to tell is one I’ve told before, most recently at the Lorne Trottier Science Symposium, where I gave a talk on cancer cure “testimonials,” although at the time I gave the talk the story’s outcome, although predictable, was not yet known.

Now it is.

The woman to whom I refer is named Kim Tinkham, who was diagnosed with breast cancer over three and a half years ago. Regular readers may recall that Kim Tinkham achieved fame not long after that when she was featured on The Oprah Winfrey Show in an episode about The Secret, an episode I discussed posts entitled The Oprah-fication of Medicine and On the nature of “alternative” medicine cancer cure testimonials. I don’t want to discuss the utter nonsense that is The Secret in any detail here. However, for those unfamiliar with this particular bit of New Age woo, it’s important to point out that The Secret’s “Law of Attraction” takes the germ of a reasonable idea (namely that one’s attitudes and wishes influence whether one gets what one wants in life, something that’s been known for millennia) and goes off the deep end of woo by proclaiming that, in essence, you can get anything you want by wanting it badly enough and thinking positive thoughts. Basically “The Secret” is that you have the power to “attract” good to yourself by thinking happy thoughts (hence “the law of attraction,” which, according to Secret adherents always works). It’s an idea that resonates in so much of “alternative medicine,” such as German New Medicine or Biologie Totale. Of course, the implication of “Secret” thinking is that, if you don’t get what you want, it’s your fault, an idea that also resonates with so much “alternative” medicine, where a frequent excuse for failure is that the patient either didn’t follow the regimen closely enough or didn’t want it badly enough.

Basically, The Secret is what inspired Kim Tinkham to eschew all conventional therapy for her breast cancer and pursue “alternative” therapies, which is what she has done since 2007. Before I discuss her case in more detail, I’m going to cut to the chase, though.

This weekend, I learned that Kim Tinkham’s cancer has recurred and that she is dying. On Saturday, a reader of my other blog sent me an e-mail that informed me:
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Posted in: Cancer, Faith Healing & Spirituality, Health Fraud, Science and the Media

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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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Vaccine Wars: the NCCAM Drops the Ball

If you go to the website of the National Center for Complementary and Alternative Medicine (NCCAM), you’ll find that one of its self-identified roles is to “provide information about CAM.” NCCAM Director Josephine Briggs is proud to assert that the website fulfills this expectation. As many readers will recall, three of your bloggers visited the NCCAM last April, after having received an invitation from Dr. Briggs. We differed from her in our opinion of the website: one of our suggestions was that the NCCAM could do a better job providing American citizens with useful and accurate information about “CAM.”

We cited, among several examples, the website offering little response to the dangerous problem of widespread misinformation about childhood immunizations. As Dr. Novella subsequently reported, it seemed that we’d scored a point on that one:

…Dr. Briggs did agree that anti-vaccine sentiments are common in the world of CAM and that the NCCAM can do more to combat this. Information countering anti-vaccine propaganda would be a welcome addition to the NCCAM site.

In anticipation of SBM’s Vaccine Awareness Week, I decided to find out whether such a welcome addition has come to fruition. The short answer: nope.

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Posted in: Chiropractic, Health Fraud, Homeopathy, Legal, Medical Ethics, Naturopathy, Politics and Regulation, Public Health, Science and the Media

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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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Chelation: Compounding Pharmacy’s Problems

Chelation is the provision of a substance to increase the body’s excretion of heavy metals. In poisoning situations (lead, aluminum, iron, etc.), chelation is medically necessary, objectively effective, and approved for use. But the same term has a completely different meaning in the alternative medicine universe, where proponents often believe heavy metal toxicity is the “one true cause” of disease, and chelation can undo microvascular inflammation, atherosclerosis, and even aging itself. From early days as an unproven treatment of coronary artery disease, its use has expanded to include autism, Alzheimer’s disease, cancer, and dozens of other diseases. Today, chelation is widely available. Regrettably, my own profession, pharmacy,  facilitates this pseudoscience by manufacturing and selling chelation products.

Provoked urine tests are a common entry point to chelation therapy. Patients are given a product to provoke heavy metal excretion. The urine is tested and the patient is informed that they’re “toxic” and require chelation. Unfortunately, these results are meaningless and provide no evidence that chelation is medically necessary. But that’s the justification used for advocating a treatment regimen that will be useless at best and fatal at worst. A recent Medical Letter review concluded:

Medical Letter consultants believe that the use of chelation therapy in non-standard protocols for unsubstantiated indications should be discouraged. The results of provoked urine testing are not an acceptable basis for such treatment.

Providing chelation to patients isn’t a straightforward matter. It’s typically an intravenous infusion (though there are some oral products). Unless you’re part of the dubious TACT trial, which has administration centres across the United States and Canada, there are few products commercially available. For example, edetate calcium disodium (EDTA) is approved for sale in the United States but not Canada. Edetate disodium (also called EDTA) is not approved for sale in either country. But these products are widely available: they’re manufactured by pharmacists in pharmacies.
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Posted in: Health Fraud, Medical Ethics, Pharmaceuticals

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Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 2

NB: If you haven’t yet read Part 1 of this blog, please do so now; Part 2 will not summarize it.

At the end of Part 1, I wrote:

We do not need formal statistics or a new, randomized trial with a larger sample size to justify dismissing the Gonzalez regimen.

In his editorial for the JCO, Mark Levine made a different argument:

Can it be concluded that [the] study proves that enzyme therapy is markedly inferior? On the basis of the study design, my answer is no. It is not possible to make a silk purse out of a sow’s ear.

That conclusion may be correct in the EBM sense, but it misses the crucial point of why the trial was (ostensibly) done: to determine, once and for all, whether there was anything to the near-miraculous claims that proponents had made for a highly implausible “detoxification” regimen for cancer of the pancreas. Gonzalez himself had admitted at the trial’s inception that nothing short of an outcome matching the hype would do:

DR. GONZALEZ: It’s set up as a survival study. We’re looking at survival.

SPEAKER: Do you have an idea of what you’re looking for?

DR. GONZALEZ: Well, Jeff [Jeffrey White, the director of the Office of Cancer Complementary and Alternative Medicine at the NCI—KA] and I were just talking a couple weeks ago. You know, to get any kind of data that would be beyond criticism is—-always be criticism, but at least three times.

You would want in the successful group to be three times — the median to be three times out from the lesser successful groups.

So, for example, if the average survival with chemo, which we suspect will be 5 months, you would want my therapy to be at least — the median survival to be at least 15, 16, 17 months, as it was in the pilot study.

We’re looking for a median survival three times out from the chemo group to be significant.

Recall that the median survival in the Gonzalez arm eventually turned out to be 4.3 months.

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Posted in: Cancer, Clinical Trials, Health Fraud, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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