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Dummy Medicines, Dummy Doctors, and a Dummy Degree, Part 1: a Curious Editorial Choice for the New England Journal of Medicine

Background

This post concerns the recent article in the New England Journal of Medicine (NEJM) titled “Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma.” It was ably reviewed by Dr. Gorski on Monday, so I will merely summarize its findings: of the three interventions used—inhaled albuterol (a bronchodilator), a placebo inhaler designed to mimic albuterol, or ‘sham acupuncture’—only albuterol resulted in a clinically important improvement of bronchial airflow; for that outcome the two sham treatments were equivalent to “no intervention.” For all three interventions, however, self-reported improvements were substantial and were much greater than self-reported improvements after “no intervention.” In other words, dummy treatments made the subjects (report that they) feel better, whereas real medicine not only made them feel better but actually made them better.

Before proceeding, let me offer a couple of caveats. First, the word “doctors” in the flippant title of this post refers mainly to two individuals: Daniel Moerman, PhD, the anthropologist who wrote the accompanying editorial, and Ted Kaptchuk, the Senior Author of the trial report. It does not refer to any of the other authors of the report. Second, I have no quarrel with the trial itself, which was quite good, or with the NEJM having published it, or even with most of the language in the article, save for the “spin” that Dr. Gorski has already discussed.

My quarrels are the same as those expressed by Drs. Gorski and Novella, and by all of us on the Placebo Panel at TAM. This post and the next will develop some of those points by considering the roles and opinions of Moerman and Kaptchuk, respectively.

A True Story

Late one night during the 1960s a friend and I, already in a cannabis-induced fog, wandered into a house that had been rented by one of his friends. There were about 8-10 ‘freaks’ there (the term was laudatory at the time); I didn’t know any of them. The air was thick with smoke of at least two varieties. After an uncertain interval I became aware of a guy who was having trouble breathing. He was sitting bolt upright in a chair, his hands on his knees, his mouth open, making wheezing sounds. He took short noisy breaths in, followed by what seemed to be very long breaths out, as though he was breathing through a straw. You could hear the wheezing in both directions. Others had also noticed that he was in distress; they tried to be helpful (“hey, man, ya want some water or somethin’?”), but he just shook his head. He couldn’t talk. My friend, who had asthma himself, announced that this guy was having an asthma attack and asked if he or anyone else had any asthma medicine. No one did.

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Posted in: Acupuncture, Cancer, Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Health Fraud, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Pharmaceuticals, Public Health, Science and Medicine, Science and the Media

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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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A Skeptic In Oz

UPDATE 4/27/2011: Here’s the online video of Dr. Novella’s appearance on The Dr. Oz Show:

  1. Controversial Medicine: Alternative Health, Part 1
  2. Controversial Medicine: Alternative Health, Part 2
  3. Controversial Medicine: Alternative Health, Part 3

I must say I was a bit shocked two weeks ago when I was contacted by a producer for The Dr. Oz Show inviting me on to discuss alternative medicine. We have been quite critical of Dr. Mehmet Oz over his promotion of dubious medical treatments and practitioners, and I wondered if they were aware of the extent of our criticism (they were, it turns out).

Despite the many cautions I received from friends and colleagues (along with support as well) – I am always willing to engage those with whom I disagree. I knew it was a risk going into a forum completely controlled by someone who does not appear to look kindly upon my point of view, but a risk worth taking. I could only hope I was given the opportunity to make my case (and that it would survive the editing process).

The Process

Of course, everyone was extremely friendly throughout the entire process, including Dr. Oz himself (of that I never had any doubt). The taping itself went reasonably well. I was given what seemed a good opportunity to make my points. However, Dr. Oz did reserve for himself the privilege of getting in the last word—including a rather long finale, to which I had no opportunity to respond. Fine—it’s his show, and I knew what I was getting into. It would have been classy for him to give an adversarial guest the last word, or at least an opportunity to respond, but I can’t say I expected it.
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Posted in: Acupuncture, Herbs & Supplements, Homeopathy, Science and the Media

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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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Posted in: Chiropractic, Health Fraud, Homeopathy, Legal, Medical Ethics, Naturopathy, Politics and Regulation, Public Health, Science and the Media

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The 2010 Lorne Trottier Public Science Symposium

I really have to give those guys at McGill University’s Office for Science and Society credit. They’re fast. Remember how I pointed out that I’ve been away at the Lorne Trottier Public Science Symposium? This year, the theme was Confronting Pseudoscience: A Call to Action, and I got to share the stage with Michael Shermer, Ben Goldacre, and, of course, our host, “Dr. Joe” Schwarcz. Sadly, I couldn’t stay to see The Amazing Randi do his thing yesterday evening, but at least I did get to have breakfast with him before I left.

In any case, the reason I have to hand it to Dr. Joe and his team at McGill is because they’ve already uploaded all the videos for symposium events. Here’s the main page with the videos (the 2010 Trottier Symposium occurred on October 17, 18, and 19), and here are the individual links:

And, because I can’t resist, here are some photos taken with various people’s cell phone cameras. First, we have a lovely poster of woo that I saw at the restaurant where we had lunch on Sunday and just had to snap a quick picture of:
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Posted in: Announcements, Science and Medicine, Science and the Media

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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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The Weekly Waluation of the Weasel Words of Woo #10

The W^5/2 Hits Double Figyiz!

OK, I gotta admit that my friend Orac moved me to render this Special 10th Edition of the W^5/2™ (after a brief hiatus) by mentioning it today in the context of an article that used, er, the topic of our venerable game to great advantage! Some of it is brilliant, unprecedented even:

Perhaps most tellingly, the U.S. Internal Revenue Service approved acupuncture as a deductible medical expense in 1973.

My hat is off to whoever came up with that one! Hey, y’gotyer basic logical fallacies, right? Y’gotyer appeal to tradition, yer appeal to popularity (or, as Orac put it, yer argumentum ad populum—sheece, is he a snob er what?), yer appeal to authority, which, I shpoze, an appeal to the IRS is a species of, as it were (hmmm: is that appeal heard in Tax Court?)…but there’s something just a little more special about this than just that. Therefore I propose, in the Tremendous (and Trendy!) Tradition of Trademarked Titles long associated with the Wonderful W^5/2™, a bran’, spankin’ new fallacy of its own, presented, of course, in a tasteful Madison Avenue format:

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Posted in: Acupuncture, Homeopathy, Humor, Science and Medicine, Science and the Media

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Nine differences between “us and them,” nine straw men burning

I’ll start this post by admitting right up front: I blatantly stole the idea for the title of this post from Mark Crislip’s most excellently infamous post Nine questions, nine answers. Why? Because I really liked that post and felt like it. Also, there seems to be something about the number nine among anti-vaccine zealots: Nine “questions.” Nine circles of hell.

Nine straw men.

I’m referring to an amazing post that appeared on the anti-vaccine crank blog Age of Autism over the weekend by contributing editor Julie Obradovic entitled The Difference Between You and Me. In this post, Julie describes not one difference, but nine differences, that she perceives between herself (and, apparently, by generalization other parents who have become believers in the myth that vaccines cause autism) and people like SBM contributors and (I hope) the vast majority of our readers, who support science-based medicine, understanding that correlation does not necessarily equal causation and that, most importantly, science not only does not support the belief that vaccines cause autism but provides us with copious evidence that there almost certainly no link between the two. Actually, there are more than nine differences, as Ms. Obradovic packs multiple apparently related differences around each of her nine “differences” and then complains that Alison Singer and, apparently by generalization the rest of us who support SBM and oppose the anti-vaccine movement, misrepresent the reasons why she and her merry band of anti-vaccine activists reject the science that has failed spectacularly to validate their deeply held belief that vaccines cause autism and all sorts of other health consequences. Her post ends up being a collection of straw men constructed to Burning Man size, each of which she then applies a flamethrower of burning nonsense to with self-righteous gusto.
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Posted in: Public Health, Science and the Media, Vaccines

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Is there a role for speculative journals like Medical Hypotheses in the scientific literature?

The core information supporting science-based medicine resides in the scientific literature. There, scientists and physicians publish the results of experiments and clinical trials that seek to understand the biological mechanisms by which the human body functions and through which disease forms and to apply this understanding to test new treatments for diease. Consequently, the quality and integrity of the biomedical literature are topics of utmost importance to supporters of science-based medicine. We’ve discussed problems with the scientific literature before here, ranging from how pseudoscientific “complementary and alternative medicine” journals have insinuated themselves into the medical literature and how drug companies have managed exercise undue influence over clinical trials and journals.

One question that perhaps we have not dealt with so much is the question of the very nature of a good scientific journal, particularly what is suitable material for such a journal. For purposes of this discussion, I will focus mainly on the biomedical literature, which spans a range from basic science journals dealing with biomedical science to clinical journals, which mainly report the results of clinical trials and clinical research. Of these journals, there are in general two types, journals that primarily report original research and those that present reviews of existing research. Most journals do a mix of the two, the majority tending towards a form where most of the articles are reports of orginal research mixed in with a much smaller number of review articles.

There is one journal, however, that is different. It is a journal known as Medical Hypotheses. It is a journal that (or so it claims) exists to present radical scientific ideas, the more radical the better. Here is how the journal is described on its website:
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Posted in: Medical Academia, Science and Medicine, Science and the Media

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