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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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Mike Adams on Dr. Mehmet Oz’s colon polyps: “Spontaneous” disease?

Given that it’s a holiday and I debated whether or not I even wanted to post anything today, I think I’ll keep things light and uncharacteristically brief today. After all, not every post can be like last week’s epic on Avastin or the week before’s epic on peer review. That’s a lot of work, and it is a holiday, after all. Besides, sometimes a perverse mood overtakes me, and I feel the need to go slumming.

Bring on Mike Adams.

Mike Adams, as regular readers may know, runs the website NaturalNews.com from deep in the jungles of Ecuador. His website is a one-stop shop, a repository if you will, of virtually every quackery known to humankind, all slathered with a heaping, helping of unrelenting hostility to science-based medicine and science in general. True, Mike Adams is not as big as, say, Joe Mercola, whose website, as far as I can tell, appears to draw more traffic than NaturalNews.com, but what Adams lacks in fame he makes up for in sheer crazy. If you don’t believe me, check out his latest hip-hop video Vaccine Zombie:

This text will be replaced by the player

Personally, if I had anything to do with the Michael Jackson estate, I’d be suing for copyright infringement. Still, grudgingly, I have to admit that the animation is pretty good, although when Mike Adams raps, “‘Cause livin’ without a brain ain’t half bad,” I don’t think he realizes that he is apparently living proof of that. In fact, so full of crazy is Mike Adams, that there has even been disagreement among SBM bloggers over whether we should lower ourselves to deal with some of his loonier stuff. Guess which side I took?

The reason I argue that, even at the risk of wrestling the proverbial pig in mud, we should not shy away from taking on some of Mike Adams’ lunacy from time to time is because he illustrates certain aspects of the mindset that allows unscientific so-called “alternative” medicine to remain popular. Sometimes, articles on Adams’ website bring up the question of whether Adams really believes the utter nonsense he lays down or whether he is simply a scammer, much like Kevin Trudeau is a scammer, and doesn’t believe a word of it but has such contempt for his followers that he thinks nothing of lying to them to sell them whatever nostrums he’s hawking on his website. You’ll see what I mean in a minute. I hope.

On Friday, Adams decided to attack “America’s doctor” and a promoter of woo whom we have from time to time taken on here at SBM, Dr. Mehmet Oz because, of all things, Dr. Oz apparently underwent colonoscopy and was found to have a precancerous polyp. That this might have happened to him is not at all surprising given that Dr. Oz recently turned 50 and current guidelines recommend commencing screening by colonoscopy at age 50. Indeed, I’m only a couple of years from needing to submit to the same screening myself. In any case, Adams decided to write one of his patented screeds, entitled, Dr. Oz colon polyps raises question of “spontaneous disease” without cause. In it, he inadvertently reveals a lot about alt-med thinking, making it worth a brief discussion.

Adams starts out:
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Posted in: Cancer, Health Fraud

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Alchemy Is Back

Alchemy is alive and well! Yes, that medieval precursor of chemistry, that chimerical search for the philosopher’s stone and the transmutation of lead to gold. Modern alchemists have found the philosopher’s stone and are selling it and teaching people how to make it themselves out of dew and Celtic sea salt.

The philosopher’s stone apparently is an elixir of life that you have to take on a regular basis. According to Nicholas Collette, it “completely eliminates the pharmaceutical industries by curing EVERY disease, and opens the mind to it’s [sic] full potential.”   It extends the life span, reverses the aging process, and opens the door to psychic power.

Instructions for making it are detailed on this website. It takes time and is complicated, but the starting ingredient is simple: morning dew.  (more…)

Posted in: Health Fraud, Science and Medicine

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