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Randi issues a challenge

Lest I be left out of the fun, I can’t help but point out that yesterday the Amazing One himself, James Randi, issued a challenge to manufacturers of homeopathic remedies and retail pharmacies that sell such remedies, in particular large national chains like Walgreens and CVS and large national chains that include pharmacies in their stores, such as Walmart and Target. This was done in conjunction with the 10:23 Challenge, which is designed to demonstrate that homeopathy is nonsense. All over the world, skeptics and supporters of science-based medicine gathered to engage in overdoses of homeopathic medicines in order to demonstrate that there is nothing in them.

As much as I like Randi, unfortunately, I doubt that the prospect of winning $1 million will make much difference to huge companies like Boiron (a French company that manufactures popular homeopathic remedies), Walmart, or Walgreens, but I do like the spirit of the protest, in particular how it drives home a very simply message about homeopathy: There’s nothing in it.

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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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CAM and the Law Part 4: Regulation of Supplements and Homeopathic Remedies

Another major set of legal standards that apply to alternative medicine are the laws and regulations that govern the manufacturing and availability of homeopathic and herbal remedies and dietary supplements. Although there is less ambiguity in these standards than in some of the areas I’ve covered previously, there are certainly loopholes aplenty available to avoid the need for any truly scientific standards of evaluating safety and efficacy. This is perhaps the area in which the triumph of politics over science is most vivid.

Regulation of Homeopathic Remedies

The Food and Drug Administration was constituted as the agency responsible for regulating medicines and most foods by the Food, Drug, and Cosmetic Act (FDCA) of 1938. The FDCA has been updated and amended in various ways since then, but it is still the primary law governing the regulation of prescription and non-prescription substances used to treat illness. The law identifies substances acceptable for sale as medicines as those listed in its official compendia, the United States Pharmacopeia-National Formulary (USP-NF) and the Homeopathic Pharmacopeia of the United States (HPUS). The HPUS was a list of homeopathic remedies first published by the American Institute of Homeopathy, a professional body for homeopaths, in 1897 and now published and maintained by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), an independent organization of homeopathic “experts.” The inclusion of homeopathic remedies as accepted drugs in the original legislation was primarily due to the efforts of Senator Royal Copeland, a physician trained in homeopathy and one of the principle authors of the FDCA.1
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Posted in: Homeopathy, Legal, Science and Medicine

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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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What’s with the new cough and cold products?

One of my earliest lessons as a pharmacist working in the “real world” was that customers didn’t always act the way I expected. Parents of sick children frequently fell into this category — and the typical vignette went like this for me:

  1. Parent has determined that their child is sick, and needs some sort of over-the-counter medicine.
  2. Parent asks pharmacist for advice selecting a product from the dozens on the shelves.
  3. Pharmacist uses the opportunity to provide science-based advice, and assures parent that no drug therapy is necessary.
  4. Parent directly questions the validity of this advice, and may ask about the merits of a specific product they have already identified.
  5. Pharmacist explains efficacy and risk of the product, and provides general non-drug symptom management suggestions.
  6. Parent thanks pharmacist, selects product despite advice, and walks to the front of the store to pay.

In many ways, a pharmacy purchase mirrors the patient-physician interaction that ends with a prescription being written — it’s what feels like the logical end to the consultation, and without it, feels incomplete. It’s something that I’m observing more and more frequently when advising parents about cough and cold products for children.

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Posted in: Homeopathy, Legal, Science and Medicine

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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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“Integrative” oncology: Trojan horse, quackademic medicine, or both?

One of the main topics that we’ve covered here on this blog over the last couple of years is the relatively rapid, seemingly relentless infiltration of pseudoscience into what should be bastions of science-based medicine (SBM), namely medical schools and academic medical centers promoted by academics who should, but apparently don’t, know better. From the very beginning, we’ve written numerous posts about this infiltration and how it has been facilitated by a variety of factors, including changes in the culture of medical academia and our own culture in general, not to mention a dedicated cadre of ideologues such as the Bravewell Collaboration, whose purpose is to blur the lines between science and pseudoscience and promote the “integration” of quackery into science-based medicine. Certainly promoters of what Dr. Robert W. Donnell termed “quackademic medicine” wouldn’t put it that way, but I would. Indeed, promoters of quackademic medicine scored a major victory last month, when a credulous piece of tripe about acupuncture passing as a review article managed to find its way into the New England Journal Medicine, a misstep that was promptly skewered by Mark Crislip, Steve Novella, and myself. It’s rare for more than two of us to write about the same topic, but it was earned by a mistake as dire as the editors of the NEJM allowing rank pseudoscience to sully its normally science-based pages.

Today, I want to riff a bit on one aspect of this phenomenon. As a cancer surgeon, I’ve dedicated myself to treating patients with cancer and then subspecialized even further, dedicating myself to the surgical treatment of breast cancer. Consequently, the interface of so-called “complementary and alternative medicine” (CAM) in the treatment of cancer both interests and appalls me. The reason for my horror at the application of CAM to cancer patients, as you might expect, is that cancer is a disease that is highly feared and can be highly deadly, depending upon the specific kind of cancer. Cancer patients deserve nothing less than the best science-based evidence that we have to offer, free of pseudoscience. Yet in even the most highly respected cancer centers, such as M.D. Anderson Cancer Center and Memorial Sloan-Kettering Cancer Center, there are departments or divisions of what is increasingly called “integrative oncology.” The claim behind “integrative oncology” is that it is “integrating the best of science-based and ‘alternative’ medicine,” but in reality all too often it is “integrating” quackery with science-based medicine. I have yet to hear an explanation of how “integrating” pseudoscience or nonscience into science-based oncology benefits cancer patients, but, then, that’s probably just the nasty old reductionist in me. Let’s find out.
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Posted in: Acupuncture, Cancer, Homeopathy, Naturopathy

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Taking On Homeopathy in Germany

Homeopathy is having a bad year. From a scientific point of view, it has had a couple of bad centuries. The progress of our scientific understanding of biology, chemistry, and physics has failed to confirm any of the core beliefs of homeopathy. Like does not cure like (this is a form of superstition known as sympathetic magic, with no basis in science). Diluting substances does not make them stronger – a notion that violates the chemical law of mass action and the laws of thermodynamics. And countless clinical studies have shown that homeopathic preparations are nothing more than placebos. That homeopathy cannot work and does not work is settled science, as much as it is possible for science to be settled.

Despite the science, homeopathy has persevered through a combination of cultural inertia and political support. But in the last year there are signs that this trend may be reversing. In the UK The House of Commons Science and Technology Committee (STC) released a report, Evidence Check 2: Homeopathy, in which they conclude that homeopathy is failed science and should be completely abandoned – no further support in the NHS and no further research.

Following that the British Medical Association has openly called for an NHS ban on homeopathy, calling the practice “witchcraft.”

Now German politicians are starting to echo the same sentiments. (more…)

Posted in: Homeopathy

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New CMS Chief Donald Berwick: a Trojan Horse for Quackery?

NB: I posted this on Health Care Renewal a couple of days ago, figuring that Dr. Gorski’s post would suffice for the SBM readership (he and I had discussed the topic while at TAM8 last week). But Managing Editor Gorski has asked me to repost it here, which I’m happy to do. I am especially pleased to demonstrate that I am capable of writing a shorter post than is Dr. Gorski. ;-)

On July 7, President Obama appointed Dr. Donald Berwick as Administrator of the Centers for Medicare and Medicaid Services (CMS). Dr. Berwick, a pediatrician, is well known as the CEO of the non-profit Institute for Healthcare Improvement (IHI), which “exists to close the enormous gap between the health care we have and the health care we should have — a gap so large in the US that the Institute of Medicine (IOM) in 2001 called it a ‘quality chasm’.” Dr. Berwick was one of the authors of that IOM report. His IHI has been a major player in the patient safety movement, most notably with its “100,000 Lives Campaign” and, more recently, its “5 Million Lives Campaign.”

Berwick’s CMS gig is a “recess appointment”: it was made during the Senate’s July 4th recess period, without a formal confirmation hearing—although such a hearing must take place before the end of this Senate term, if he is to remain in the position. A recent story suggested that Obama had made the recess appointment in order to avoid a reprise of “last year’s divisive health care debate.” The president had originally nominated Berwick for the position in April, and Republicans have opposed “Berwick’s views on rationing of care,” claiming that he “would deny needed care based on cost.”

A “Patient-Centered Extremist”

If there is a problem with the appointment, it is likely to be roughly the opposite of what Republicans might suppose: Dr. Berwick is a self-described “Patient-Centered Extremist.” He favors letting patients have the last word in decisions about their care even if that means, for example, choosing to have unnecessary and expensive hi-tech studies. In an article for Health Affairs published about a year ago, he explicitly argued against the “professionally dominant view of quality of health care”:

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Posted in: Health Fraud, Homeopathy, Medical Ethics, Politics and Regulation, Science and Medicine, Science and the Media

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Cancer Treatment Centers of America and “naturopathic oncology”

EDITOR’S NOTICE: NOTE THE DISCLAIMER.

On “wholistic” medicine

If there’s one aspect of so-called “alternative medicine” and “complementary and alternative medicine” (CAM) is that its practitioners tout as being a huge advantage over what they often refer to sneeringly as “conventional” or “scientific” medicine is that — or so its practitioners claim — alt-med treats the “whole patient,” that it’s “wholistic” in a way that the evil reductionist “Western” science-based medicine can’t be. Supposedly, we reductionistic, unimaginative physicians only focus on disease and ignore the “whole patient.” Of course, to me this claim is belied by the hectoring to which my own primary care physician has subjected me about my horrible diet and lack of exercise on pretty much every visit I’ve had with her, but then maybe she’s an anomaly, along with Dr. Lipson on this very blog and pretty much every other primary care doctor I’ve ever dealt with. Anecdotal experience, I know, but since alt-med mavens appear to value anecdotal evidence above pretty much all else I thought it appropriate to mention here. Also belying the claim of alt-med practitioners that they “individualize” treatments to their patients in a way that science-based medicine does not is the maddening tendency of various alt-med modalities to settle on just One True Cause of All Disease, be it liver flukes as the One True Cause of Cancer, heavy metal toxicity as the One True Cause of cancer, autism, and various other diseases, or “allergies,” acid, or obstruction of the flow of qi as the One True Cause of All Disease.

Given the claim of “wholism” that is such an advertising gimmick among many of the varieties of woo, I’m always interested when I see evidence that alt-med is imitating its envied and disliked reductionistic competition. True, this is nothing new, given how alt-med has tried to seek legitimacy by taking on the mantle of science-based medicine wherever it can. Examples include the National Center for Complementary and Alternative Medicine (NCCAM), various organizations that try to confer legitimacy to pseudoscience by providing “certification” in various flavors of woo, and moves to push state medical boards to go further than that and confer legally protected status to practitioners by actually licensing them. This latter tactic has been very successful in that many states now license acupuncturists, while some states even license naturopaths and “homeopathic physicians,” the latter of which I find quite amusing because the term perfectly encapsulates what must remain of such a physician’s medical training after being diluted to 30C with woo. The only difference is that, unlike what is claimed with homeopathy, diluting MD medical knowledge with woo does not make it stronger. In terms of naturopathy, though, one of the most alarming aspects of the infiltration of naturopaths into the health care system is that some states in the U.S. and provinces in Canada are seriously considering allowing them to prescribe real pharmaceutical medications, even though they lack the training and knowledge to use such drugs safely.

Imagine my combination of bemusement and alarm, then, when I learned of a new specialty of pseudoscience, namely the field of naturopathic oncology.

Be afraid. Be very afraid. (I know I was when I first encountered this specialty.)
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Posted in: Cancer, Chiropractic, Homeopathy, Science and Medicine

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