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Posts Tagged National Center for Complementary and Alternative Medic

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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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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Cochrane is Starting to ‘Get’ SBM!

This essay is the latest in the series indexed at the bottom.* It follows several (nos. 10-14) that responded to a critique by statistician Stephen Simon, who had taken issue with our asserting an important distinction between Science-Based Medicine (SBM) and Evidence-Based Medicine (EBM). (Dr. Gorski also posted a response to Dr. Simon’s critique). A quick-if-incomplete Review can be found here.

One of Dr. Simon’s points was this:

I am as harshly critical of the hierarchy of evidence as anyone. I see this as something that will self-correct over time, and I see people within EBM working both formally and informally to replace the rigid hierarchy with something that places each research study in context. I’m staying with EBM because I believe that people who practice EBM thoughtfully do consider mechanisms carefully. That includes the Cochrane Collaboration.

To which I responded:

We don’t see much evidence that people at the highest levels of EBM, eg, Sackett’s Center for EBM or Cochrane, are “working both formally and informally to replace the rigid hierarchy with something that places each research study in context.”

Hallafrickin’loo-ya

Well, perhaps I shouldn’t have been so quick to quip—or perhaps that was exactly what the doctor ordered, as will become clear—because on March 5th, nearly four months after writing those words, I received this email from Karianne Hammerstrøm, the Trials Search Coordinator and Managing Editor for The Campbell Collaboration, which lists Cochrane as one of its partners and which, together with the Norwegian Knowledge Centre for the Health Services, is a source of systematic reviews:

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Posted in: Clinical Trials, Energy Medicine, Medical Academia, Science and Medicine

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Of SBM and EBM Redux. Part IV, Continued: More Cochrane and a little Bayes

OK, I admit that I pulled a fast one. I never finished the last post as promised, so here it is.

Cochrane Continued

In the last post I alluded to the 2006 Cochrane Laetrile review, the conclusion of which was:

This systematic review has clearly identified the need for randomised or controlled clinical trials assessing the effectiveness of Laetrile or amygdalin for cancer treatment.

I’d previously asserted that this conclusion “stand[s] the rationale for RCTs on its head,” because a rigorous, disconfirming case series had long ago put the matter to rest. Later I reported that Edzard Ernst, one of the Cochrane authors, had changed his mind, writing, “Would I argue for more Laetrile studies? NO.” That in itself is a reason for optimism, but Dr. Ernst is such an exception among “CAM” researchers that it almost seemed not to count.

Until recently, however, I’d only seen the abstract of the Cochrane Laetrile review. Now I’ve read the entire review, and there’s a very pleasant surprise in it (Professor Simon, take notice). In a section labeled “Feedback” is this letter from another Cochrane reviewer, which was apparently added in August of 2006, well before I voiced my own objections:

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Posted in: Clinical Trials, Homeopathy, Medical Academia, Science and Medicine

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The NCCAM Strategic Plan 2011-2015: The Good, The Bad, and The Ugly

As hard as it is to believe, it’s been nearly a year since Steve Novella, Kimball Atwood, and I were invited to meet with the director of the National Center for Complementary and Alternative Medicine (NCCAM), Dr. Josephine Briggs. Depending upon the day, sometimes it seems like just yesterday; sometimes it seems like ancient history. For more details, read Steve’s account of our visit, but the CliffsNotes version is that we had a pleasant conversation in which we discussed our objections to how NCCAM funds dubious science and advocacy of complementary and alternative medicine (CAM). When we left the NIH campus, our impression was that Dr. Briggs is well-meaning and dedicated to increasing the scientific rigor of NCCAM studies but doesn’t understand the depths of pseudoscience that constitute much of what passes for CAM. We were also somewhat optimistic that we had at least managed to communicate some of our most pressing practical concerns, chief among which is the anti-vaccine bent of so much of CAM and how we hoped that NCCAM would at least combat some of that on its website.

Looking at the NCCAM website, I see no evidence that there has been any move to combat the anti-vaccine tendencies of CAM by posting pro-vaccination pieces or articles refuting common anti-vaccine misinformation. Of all the topics we discussed, it was clearest that everyone, including Dr. Briggs, agreed that the NCCAM can’t be perceived as supporting anti-vaccine viewpoints, and although it doesn’t explicitly do so, neither does it do much to combat the anti-vaccine viewpoints so ingrained in CAM. As far as I’m concerned, I’m with Kimball in asserting that NCCAM’s silence on the matter is in effect tacit approval of anti-vaccine viewpoints. Be that as it may, not long afterward, Dr. Briggs revealed that she had met with homeopaths around the same time she had met with us, suggesting that we were simply brought in so that she could say she had met with “both sides.” Later, she gave a talk to the 25th Anniversary Convention of the American Association of Naturopathic Physicians (AANP), which is truly a bastion of pseudoscience.

In other words, I couldn’t help but get the sinking feeling that we had been played. Not that we weren’t mildly suspicious when we traveled to Bethesda, but from our perspective we really didn’t have a choice: if we were serious about our mission to promote science-based medicine, Dr. Briggs’ was truly an offer we could not refuse. We had to go. Period. I can’t speak for Steve or Kimball, but I was excited to go as well. Never in my wildest dreams had it occurred to me that the director of NCCAM would even notice what we were writing, much less take it seriously enough to invite us out for a visit. I bring all this up because last week NCCAM did something that might provide an indication of whether it’s changed, whether Dr. Briggs has truly embraced the idea that rigorous science should infuse NCCAM and all that it does, let the chips fall where they may. Last week, NCCAM released its five year strategic plan for 2011 to 2015.

Truly, it’s a case of The Good, The Bad, and The Ugly.
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Posted in: Basic Science, Clinical Trials, Politics and Regulation

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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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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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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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Tai chi and fibromyalgia in the New England Journal of Medicine: An “alternative” frame succeeds

It never seems to fail. I go away for a few days, in this case to combine fun with pleasure and pleasure with fun by giving a talk to the Chicago Skeptics and at the same time meeting my brand new (well, by this time three weeks old) nephew for the first time, and something always happens. Before I get to what happened, I just want to point out that the talk actually went pretty darned well. I was utterly shocked that it was pretty much standing room only, with perhaps 50 people there to hear me. Honestly, don’t you people have anything better to do on a beautiful Saturday afternoon in August? But, seriously, the whole thing was a blast, and the assembled skeptics there didn’t even let me off the hook, as at least a couple of them asked some fairly challenging questions, one of which, I must admit, I wasn’t prepared for. In any case, my thanks go out to Dr. Jennifer Newport, skeptical Chicago pediatrician extraordinaire and organizer of my talk and the party at her apartment afterward. Between the two events she raised hundreds of dollars for the vaccination drive going on at DragonCon this weekend, Chicago Skeptics, the Women Thinking Free Foundation, and CFI-Chicago for inviting me and being such fantastic hosts.

Back to business. Science-based medicine (SBM) business, that is.

What happened while I was away could almost be characterized by the New England Journal of Medicine (NEJM) singing “Oops, I did it again.” Three weeks ago, the hallowed pages of the NEJM hosted a truly execrably credulous review article about acupuncture. So bad was the article that it “merited” the incredibly rare triple beat-down from this very blog, with posts by Steve Novella, the ever-irascible Mark Crislip, and myself in rapid succession applying the clue-by-four. As I was preparing to leave for Chicago on Thursday, I happened to look at the very latest issue of the NEJM hot off the presses, and what to my wondering (and watering–it is ragweed season) eyes should appear but an article reporting a study on the use of tai chi in treating fibromyalgia. Entitled A Randomized Trial of Tai Chi for Fibromyalgia, the study comes out of the Tufts University School of Medicine and the Newton-Wellesley Hospital in Boston and was carried out by a team led by Chenchen Wang, MD, MPH. Not surprisingly, the study has gotten a lot of play in the media, for example, in this story in the L.A. Times, which is at least reasonably restrained, probably because it an AP wire story by Marilynn Marchione, who has written some excellent articles about “alternative” medicine before. Even the usually reliable GoozNews seems smitten with this study beyond what it rates, characterizing it as “rare victory for the National Institute of Health’s National Center for Complementary and Alternative Medicine and Sen. Tom Harkin (D-IA), who routinely comes under fire for pushing funding for these types of studies.”

I’m less impressed. You’ll see what I mean in a few minutes, I hope. First, however, let’s look at the study itself.
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