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Utah Senator Orrin Hatch: A pit bull in defense of the supplement industry

Editor’s note: This weekend was truly NIH grant crunch time. I have to get my final version of my R01 to our university’s grants office by Tuesday, or it might not get uploaded by the July 5 deadline. (Funny how electronic submission, which was supposed to make applicants’ lives easier, seems to have made them harder.) Consequently, I decided to take a few minutes and spiff up a post I did not long ago for my other blog and use it here, mainly because it is particularly relevant to our usual SBM topics. I’ll be back next time with something new.

The weakness and ineffectiveness of the law in the U.S. regulating dietary supplements has been a frequent topic here on Science-Based Medicine, including the continued failure of efforts to address the serious shortcomings of current law and the illogic at its very heart. Indeed, over the last decade or so that I’ve paid attention to relevant issues regarding supplements continually amazed at how much supplement manufacturers can get away with and for how long. For example, one of the most recent atrocities against science occurred when Boyd Haley, disgraced chemistry professor at the University of Kentucky and prominent member of the mercury militia wing of the anti-vaccine movement, tried to sell an industrial chelator as a dietary supplement to treat autistic children. True, that was too much even for the underfunded, undermanned FDA to ignore, but it was amazing how long he got away with it. Apparently it takes someone trying to market a chemical compound that can’t by any stretch of the imagination be characterized as a “nutrient” or “food” to be so obviously against even the travesty of a mockery of a sham of a law regulating supplements (the Dietary Supplement Health and Education Act of 1994, or the DSHEA) that the FDA could take action.

Of course, here at SBM, we’ve written numerous posts on the shortcomings of the DSHEA. Basically, this law created a new class of regulated entities known as dietary supplements and liberalized the sorts of information that supplement manufacturers could transmit to the public. The result has been this:

It [the DSHEA] also expanded the types of products that could be marketed as “supplements.” The most logical definition of “dietary supplement” would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.

One might wonder how such a bad law could survive for so long (seventeen years now), but it has its defenders. One man, in particular, defends the DSHEA against all regulatory threats, foreign and domestic. His name is Senator Orrin Hatch (R-UT), and he was just the subject of a writeup in the New York Times last week referring to him as a “natural ally” of the supplement industry:
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Posted in: Herbs & Supplements, Pharmaceuticals, Politics and Regulation

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“CAM” Education in Medical Schools—A Critical Opportunity Missed

Mea culpa to the max. I completely forgot that today is my day to post on SBM, so I’m going to have to cheat a little. Here is a link to a recent article by yours truly that appeared on Virtual Mentor, an online ethics journal published by the AMA with major input from medical students. Note that I didn’t write the initial scenario; that was provided to me for my comments. The contents for the entire issue, titled “Complementary and Alternative Therapies—Medicine’s Response,” are here. Check out some of the other contributors (I was unaware of who they would be when I agreed to write my piece).

Posted in: Acupuncture, Basic Science, Chiropractic, Energy Medicine, Herbs & Supplements, History, Homeopathy, Medical Academia, Medical Ethics, Science and Medicine

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Et tu, Biomarkers?

Everything you know may be wrong. Well, not really, but reading the research of John Ioannidis does make you wonder. His work, concentrated on research about research, is a popular topic here at SBM.  And that’s because he’s focused on improving the way evidence is brought to bear on decision-making. His most famous papers get to the core of questioning how we know what we know (or what we assume) to be evidence. (more…)

Posted in: Basic Science, Clinical Trials, Diagnostic tests & procedures, Epidemiology, Science and Medicine

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We get mail

There are a few “laws” of the blogosphere, one of them being that a response to a post that comes more than a few weeks later is generally useless or crazy.  But once in a while, someone takes the time to look at an old post and formulate a thoughtful response.

This is not one of those times.

Or maybe it is.  I’ll report (and editorialize), you decide.

Regarding a piece I first published in September of 2010, a reader writes:

Dear Dr. Gorski:[our managing editor]

I am writing regarding your comments on the following blog

https://www.sciencebasedmedicine.org/index.php/your-disease-your-fault/#more-6747

I am not a doctor but am pursuing an MA and hopefully a PhD in nutrition and public health. I am very familiar with Dr. Fuhrman and his work. I have heard many of Dr. Fuhrman’s lectures and if anything they are all based on concrete scientific research. I must express my disappointment about both the tone and factual content of the article written. I read extensively about nutrition, exercise and their health benefits. Much of the research done in this field has been conducted in small clinical trials or in the laboratory. There is a good reason for this. Only the government has the financial ability to pay the tens of millions of dollars needed to conduct large scale clinical trials in this area since a drug company would in all probability not have any financial gain from a clinical trial showing that individuals eating 10 servings of vegetables each day have a significant reduction in chronic disease. I do feel that all epidemiological as well as clinical work done points to the very clear fact that people die years before they need to due to the poor diets they have. It is also very clear that most physicians have very little knowledge about nutrition since it is generally a very minor part of their education. I agree with doctor Fuhrman that any debate should be both science based and held to the highest ethical standards. From what I see the article written as well as your comments do not meet these standards. I find that most disconcerting due to the fact that individuals put their lives in their hands when they consult with you as a physician.

In closing I would like your comment on the follwing statement that was made by Dr. William Castelli, who ran the Framingham Study for about 20 years. An interviewer asked him what percent of heart disease could be avoided through proper nutrition and exercise. His response was very brief. 100%!! Do you agree with one of foremost reaearcers of the 20th century or do you consider him to be a quack too.

I await your response.

Sincerely,

[Name redacted]

What is instructive here is the usual thoughtful but incorrect “reasoning” used by someone with just enough knowledge to think he understands the topic at hand well enough to rebut.  The rebuttal, however, makes use of the usual fallacies that are the fallback position for the ignorant and the mendacious (and I must point out that I think our Dear Correspondent is the former).

Since I wrote the piece, not Dr. Gorski, I take full responsibility for its content and defend my writing personally.  A bit of a fisking is in order to help us all better understand how to think about these questions properly.

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Posted in: Science and Medicine

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Kudos to Steven Novella

It has just been announced, in the July/August issue of Skeptical Inquirer magazine, that our own Steven Novella has been awarded the 2010 Robert P. Balles Annual Prize in Critical Thinking. It will be formally presented at the CSIcon conference in New Orleans on October 28, 2011. The Prize is a $1500 award given to the author of the published work or body of work that best exemplifies healthy skepticism, logical analysis, or empirical science. The Committee for Skeptical Inquiry (CSI) selects the publication that, in its judgment, has the greatest potential to create positive reader awareness of currently important scientific concerns. Previous awards starting in 2005 were for individual publications. In Dr. Novella’s case, the award was for his entire body of work. In the letter informing him of his selection, CSI Executive Director Barry Karr said,

…you are being honored for your tremendous body of work including The Skeptic’s Guide to the Universe, Science-Based Medicine, Neurologica, your SKEPTICAL INQUIRER column “The Science of Medicine,” as well as your tireless travel and lecture schedule on behalf of skepticism. You may well be the hardest worker in all of skepticism today. And to me, the truly amazing thing is you do all of this on a volunteer basis.

He is also the president and co-founder of the New England Skeptical Society, a fellow of CSI, a founding fellow of the Institute for Science in Medicine, a medical advisor to Quackwatch, a contributor to other blogs, has produced a course for The Teaching Company on “Medical Myths, Lies, and Half-Truths,” and is Senior Fellow and Director of the James Randi Educational Foundation’s (JREF) new Science-Based Medicine project. And I have undoubtedly omitted several of his other accomplishments.

It is hard to believe he hasn’t cloned himself, since all of these achievements are in addition to his demanding day job as a clinical neurologist, assistant professor, and director of general neurology at Yale University School of Medicine.

Congratulations, Steve! The award couldn’t have gone to a better candidate. I want to add my personal thanks for all you do and say how proud I am to be associated with you. You da man!

 

 

 

Posted in: Announcements

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Acupuncturist’s Unconvincing Attempt at Damage Control

Acupuncture has been in the news recently. A former President of South Korea had to undergo major surgery to remove an acupuncture needle that had somehow lodged in his lung.  A recent study in Pain compiled a list of 95 published reports of serious complications of acupuncture including 5 deaths. Meanwhile, acupuncturists continue to insist that their procedures are “safe.”

Edzard Ernst et al.’s article Acupuncture: Does it alleviate pain and are there serious risks? A review of reviews was published in the journal Pain in April 2011. It had two parts: (1) it was a systematic review of 57 systematic reviews showing that there was “little truly convincing evidence that acupuncture is effective in reducing pain,” and (2) it tabulated published reports of 5 deaths and 90 other serious complications of acupuncture treatments. I wrote an accompanying commentary, “Acupuncture’s claims punctured: Not proven effective for pain, not harmless.”

William Morris chastised me for not declaring a conflict of interest (!?) in my commentary. Now, in Acupuncture Today, he has criticized the Ernst et al. study itself.
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Posted in: Acupuncture

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Blatant pro-alternative medicine propaganda in The Atlantic

Some of my fellow Science-Based Medicine (SBM) bloggers and I have been wondering lately what’s up with The Atlantic. It used to be one of my favorite magazines, so much so that I subscribed to it for roughly 25 years (and before that I used to read my mother’s copy). In general I enjoyed its mix of politics, culture, science, and other topics. Unfortunately, my opinion changed back in the fall of 2009, when, on the rising crest of the H1N1 pandemic, The Atlantic published what can only be described as an terrible bit of journalism lionizing the “brave maverick doctor” Tom Jefferson of the Cochrane Collaboration. The article, written by Shannon Brownlee and Jeanne Lenzer, argued, in essence, that vaccinating against H1N1 at the time was a horrendous waste of time and effort because the vaccine didn’t work. So bad was the cherry picking of data and framing of the issue as a narrative that consisted primarily of the classic lazy journalistic device of a “lone maverick” against the entire medical establishment that it earned the lovely sarcasm of our very own Mark Crislip, who wrote a complete annotated rebuttal, while I referred to the methodology presented in the article as “methodolatry.” Even public health epidemiologist Revere (who is, alas, no longer blogging but in his day provided a very balanced, science-based perspective on vaccination for influenza, complete with its shortcomings) was most definitely not pleased.

I let my subscription to The Atlantic lapse and have not to this day renewed it.

Be that as it may, last year The Atlantic published an article that wasn’t nearly as bad as the H1N1 piece but was nonetheless pretty darned annoying to us at SBM. Entitled Lies, Damned Lies, and Medical Science, by David Freedman, it was an article lionizing John Ioannidis (whom I, too, greatly admire) while largely missing the point of his work, turning it into an argument for why we shouldn’t believe most medical science. Now, Freedman’s back again, this time with a much, much, much worse story in The Atlantic in the July/August 2011 issue under the heading “Ideas” and entitled The Triumph of New Age Medicine, complete with a picture of a doctor in a lab coat in the lotus position. It appears to be the logical follow up to Freedman’s article about Ioannidis in that Freedman apparently seems to think that, if we can’t trust medical science, then there’s no reason why we shouldn’t embrace medical pseudoscience.

Basically, the whole idea behind the article appears to be that, even if most of alternative medicine is quackery (which it is, by the way, as we’ve documented ad nauseam on this very blog), it’s making patients better because of placebo effects and because its practitioners take the time to talk to patients and doctors do not. In other words, Freedman’s thesis appears to be a massive “What’s the harm?” argument coupled with a false dichotomy; that is, if real doctors don’t have the time to listen to patients and provide the human touch, then let’s let the quacks do it. Tacked on to that bad idea is a massive argumentum ad populum portraying alternative medicine as the wave of the future, in contrast to what Freedman calls the “failure” of conventional medicine.

Let’s dig in, shall we? I’ll start with the article itself, after which I’ll examine a few of the responses. I’ll also note that our very own Steve Novella, who was interviewed for Freedman’s article, has written a response to Freedman’s article that is very much worth reading as well.

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Posted in: Acupuncture, Medical Academia, Medical Ethics, Nutrition, Science and the Media

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The Dow of Accutane

At home the kids current TV show of choice is How I Met Your Mother, supplanting Scrubs as the veg out show in the evening. Both shows are always on a cable channel somewhere and are often broadcast late at night. Late night commercials can be curious, and as I work on projects, I watch the shows and commercials out of the corner of my eye.

Law firms trolling for business seem common. If you or a family member has had a serious stroke, heart attack or death from Avandia, call now. The non-serious deaths? I suppose do not bother. One ad in particular caught my eye: anyone who developed ulcerative colitis or Crohn’s disease (collectively referred to inflammatory bowel disease, or IBD) after using Accutane, call now. Millions have been awarded.

My eye may have been caught because of my new progressive lenses, but I will admit to an interest in inflammatory bowel disease, having had ulcerative colitis for years until I took the steel cure. It also piqued my interest as these were three conditions among which I could not seen any connections. Accutane, ulcerative colitis, and Crohn’s. One of these is not like the other.

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Posted in: Legal, Politics and Regulation, Science and Medicine

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Exorcism and Sorcery as Health Benefits?!

Luis Fernando Verissimo, a Brazilian writer, once proposed “voodoopuncture”. Instead of going to the acupuncturist, you would be treated without leaving home. The voodoopuncturist would stick acupuncture needles in the voodoo dolls of you! I add that voodoopuncture could be outsourced to Haiti and/or China. It is a win-win-win situation!

— Leonardo Monasteri, Brazilian economist

As unbelievable as this might sound, “voodoopuncture” is no fiction at all.

The practice is called “Tong Ren healing,” and involves needling or hammering an acupuncture mannequin, as if it were a voodoo doll. The main Tong Ren “Master” in the US is an acupuncturist in the Boston area by the name of Tom Tam. He treats groups of terminally ill and debilitated patients in a deliverance ceremony that is noting but a revamped Taoist exorcism — only the clay or straw doll is replaced by a plastic mannequin:

Unfortunately, Tom Tam is not the only licensed healthcare provider who is treating patients with hocus pocus and crackpottery. There are over 30,000 other adepts of Traditional Chinese Medicine (TCM) in the US who practice medicine based on notions of health and disease that are rooted in paranormal and magical beliefs. Some of these practitioners take their delusions to the outer limits of absurdity: consider, for instance, “acutonics” and “colorpuncture” as described in these videos:

In anthropology of religion, the principles that underline the above practices are called “imitation” (e.g. using a doll to affect a person), and “correspondence” (e.g. using a sound to affect an object). They are the hallmarks of what is called “sympathetic magic,” meaning the belief that a person, or a thing, can be affected through something that represents it, or that has similar attributes.1 The principle of magical correspondence in TCM is called wu xing (五行) in Chinese, and is known as the Five Phases/Elements Theory in English. It can be summarized as follows:
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Posted in: Acupuncture, Politics and Regulation, Public Health

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The Value of Replication

Daryl Bem is a respected psychology researcher who decided to try his hand at parapsychology. Last year he published a series of studies in which he claimed evidence for precognition — for test subjects being influenced in their choices by future events. The studies were published in a peer-reviewed psychology journal, the Journal of Personality and Social Psychology. This created somewhat of a controversy, and was deemed by some to be a failure of peer-review.

While the study designs were clever (he simply reversed the direction of some standard psychology experiments, putting the influencing factor after the effect it was supposed to have), and the studies looked fine on paper, the research raised many red flags — particularly in Bem’s conclusions.

The episode has created the opportunity to debate some important aspects of the scientific literature. Eric-Jan Wagenmakers and others questioned the p-value approach to statistical analysis, arguing that it tends to over-call a positive result. They argue for a Bayesian analysis, and in their re-analysis of the Bem data they found the evidence for psi to be “weak to non-existent.” This is essentially the same approach to the data that we support as science-based medicine, and the Bem study is a good example of why. If the standard techniques are finding evidence for the impossible, then it is more likely that the techniques are flawed rather than the entire body of physical science is wrong.

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Posted in: Neuroscience/Mental Health

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