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Update on Josephine Briggs and the NCCAM

Dr. Gorski is in the throes of grant-writing, so I’m filling in for him today by following up on a topic introduced a few months ago. It involves a key medical player in the U.S. government: Dr. Josephine Briggs, Director of the National Center for Complementary and Alternative Medicine (NCCAM).

Background

Steve Novella and I first encountered Dr. Briggs at the 2nd Yale Research Symposium on Complementary and Integrative Medicine in March, 2010. I reported here that she seemed well-meaning and pro-science but that she also seemed naive to the political realities of her office and to much of the content of “CAM” (as illustrated by her recommending the NCCAM website, which is full of misinformation; previously I’d noticed her unfortunate innocence of “acupuncture anesthesia,” which is to be expected of most academics but not of the CAM Explicator-in-Chief).

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Posted in: Clinical Trials, Health Fraud, Herbs & Supplements, Homeopathy, Naturopathy, Politics and Regulation, Science and Medicine, Vaccines

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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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Surprise, surprise! Dr. Andrew Weil doesn’t like evidence-based medicine

ResearchBlogging.orgDr. Andrew Weil is a rock star in the “complementary and alternative medicine” (CAM) and “integrative medicine” (IM) movement. Indeed, it can be persuasively argued that he is one of its founders, at least a founder of the its most modern iteration, and I am hard-pressed to think of anyone who did more in the early days of the CAM/IM movement, back before it ever managed to achieve a modicum of unearned respectability, to popularize CAM. In fact, no physician that I can think of has over the course of his lifetime done more to promote the rise of quackademic medicine than Dr. Weil. The only forces greater than Dr. Weil in promoting the infiltration of pseudoscience into academic medicine have been the Bravewell Collaborative and the National Center for Complementary and Alternative Medicine (NCCAM). Before there was Dr. Mehmet Oz, Dr. Dean Ornish, Dr. Mark Hyman, or any of the other promoters of IM, there was Dr. Weil.

And why not? Dr. Weil looks like an aging 1960s rock star, and, operating from his redoubt at the University of Arizona, is quite charismatic. For all the world he has the appearance of a kindly, benevolent Arizona desert Santa Claus, an ex-hippie turned respectable dispensing advice about “natural” medicines, writing books, and making himself ubiquitous on television and radio whenever the topic of alternative medicine comes up. Before Dr. Oz told Steve Novella that “Western” science and medicine can’t study woo like acupuncture, Dr. Weil was there, paving the way for such arguments, previously considered ludicrous, to achieve a patina of respectability.

In fact, he’s still at it, doing it far better and far more subtly than the ham-handed Dr. Oz. Unfortunately, it’s the same anti-science message and the same appeal to other ways of knowing built upon tearing down straw men versions of evidence-based medicine (EBM) with gusto. This was brought home last week when Dr. Weil co-authored an opinion piece with Drs. Scott Shannon and Bonnie J. Kaplan for the journal Alternative and Complementary Therapies entitled Safety and Patient Preferences, Not Just Effectiveness, Should Guide Medical Treatment Decisions, an article that was noted at the blog Booster Shots in a credulous, fawning post entitled Dr. Weil says there’s a better approach to evaluating clinical drug trials. In contast, Steve Novella put it far more succinctly (and accurately) in the title of his post: Andrew Weil Attacks EBM. That’s exactly what Weil and company did in this article.

While Steve is absolutely correct, I also see it more as Dr. Weil demonstrating once again that, upstarts like Dr. Oz aside, he is still the master of CAM/IM apologia, much as, even though both were Sith Lords, Emperor Palpatine remained master over Darth Vader until just before the end. You’ll see why in terms of the arguments, both subtle and not-so-subtle, that Dr. Weil and his acolytes make. Moreover, even though his disciple Shannon is granted the coveted first author position, the arguments presented leave little doubt that it’s Weil who’s driving the bus.
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Posted in: Clinical Trials, Medical Academia

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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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An ICD Code for the Running Piglets!

… animals are divided into (a) those that belong to the emperor; (b) embalmed ones; (c) those that are trained; (d) suckling pigs; (e) mermaids; (f) fabulous ones; (g) stray dogs; (h) those that are included in this classification; (i) those that tremble as if they were mad; (j) innumerable ones; (k) those drawn with a very fine camel’s-hair brush; (l) etcetera; (m) those that have just broken the flower vase; (n) those that at a distance resemble flies.

— Jorge Luis Borges (1899–1986)1

Not too long ago, I came across a disease taxonomy proposed by a certain East-West Medical Research Institute (EWMRI), that includes the kind of fantastic afflictions — such as “running piglet” disorder — fit for the best Borgesian list.

This obscure institute, located at Kyung Hee University in Seoul, Korea, is one of the 800 WHO Collaborating Centres designated to carry out various activities in support of the Organization’s programs. With the collaboration of China, Japan, Vietnam, Australia, and the US, this center is working to incorporate medieval Asian disease nomenclature to the 11th version of the International Classification of Disease (ICD-11).
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Posted in: Acupuncture, Basic Science, Science and Medicine

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The risks of CAM: How much do we know?

Working in pharmacies where supplements are sold alongside traditional (over-the-counter) medications, I’m regularly astonished at the different perceptions consumers can have about the relative efficacy and safety of different types of products. Once, speaking with a customer about a medical condition she wanted to treat, I indicated that there were no effective non-prescription therapies — she needed to see a physician for access to an effective treatment by prescription — and I gestured behind the counter. “Back there?!” she pointed. “That’s where you keep the stuff that kills people! I want something natural!” Suggesting that my patients with heart disease or HIV had a somewhat different perspective, I tried (unsuccessfully) to talk her out of a questionable-looking supplement (Hint: avoid anything from a company with a P.O. box as a mailing address.) This appeal to nature, combined with a perception that natural products are safe, and conventional drugs are unsafe, is pervasive. (more…)

Posted in: Herbs & Supplements, Pharmaceuticals

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For Good Reason…

This one crept up on me by surprise. You see, I recorded an interview with D.J. Grothe, President of the James Randi Educational Foundation and host of the podcast For Good Reason back in November. I wasn’t sure when it would appear. Well, it turns out that it popped up on my iTunes podcast feeds sometime over the last few days. (It’s been really busy at work, and I haven’t really been paying attention to podcasts–at least, not until yesterday.)

So, here it is. I haven’t listened to it all yet, but hopefully I explained myself well enough and did credit to my fellow SBM bloggers. DJ is a good interviewer, which means he presses his subjects a bit and sometimes gets them out of their comfort zone.

Posted in: 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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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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