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The wrong way to “open up” clinical trials

Science-based medicine rests on twin pillars that are utterly essential to the development of treatments that are safe and efficacious. Both of these pillars depend on science, but in different ways. The first of these is, of course, the basic science that provides the hypotheses to test about the mechanisms behind the diseases and malfunctions that plague the human body. This basic science suggests ways of either correcting or alleviating these malfunctions in order to alleviate symptoms and prevent morbidity and mortality and how to improve health to increase quality and quantity of life. Another critical aspect of basic science is that it also provides scientists with an estimate of the plausibility of various proposed interventions, treatments and cures designed to treat disease and improve health. For example, if a proposed remedy relies upon ideas that do not jibe with some of the most well-established laws in science, such as homeopathy, the concepts behind which violate multiple laws of physics and chemistry, it’s a very safe bet that that particular treatment will not work and that we should test something else. Of course, the raison d’être of this blog derives from the unfortunate fact that in today’s medicine this is not the case and we are wasting incredible amounts of time, money, and lost opportunities in order to pursue the scientific equivalent of fairy dust as though it represented a promising breakthrough that will save medicine, even though much of it is based on prescientific thinking and mysticism. Examples include homeopathy, reiki, therapeutic touch, acupuncture, and much of traditional Chinese medicine and Ayurveda, all of which have managed to attach themselves to medical academia like kudzu.

Of course, basic science alone is not enough. Humans are incredibly complex organisms, and what we consider to be an adequate understanding of disease won’t always result in an efficacious treatment, no matter how good the science is. Note that this is not the same thing as saying that utter implausibility from a scientific basis (as is the case with homeopathy) doesn’t mean a treatment won’t work. When a proposed treatment relies on claiming “memory” for water that doesn’t exist or postulates the existence of a “life energy” that no scientific instrument can detect and the ability to manipulate that life energy that no scientist can prove, it’s a pretty safe bet that that treatment is a pair of fetid dingo’s kidneys. Outside of these sorts of cases, though, clinical trials and epidemiological studies are the second pillar of science-based medicine, in particular clinical trials, which is where the “rubber hits the road,” so to speak. In clinical trials, we take observations from the laboratory that have led to treatments and test them in humans. The idea is to test for both safety and efficacy and then to begin to figure out which patients are most likely to benefit from the new treatment.
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Posted in: Clinical Trials, Science and Medicine

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Andrew Weil and “integrative medicine”: The ultimate triumph of quackery?

A board certification in woo?

I’ve been harshly critical of the entire concept of “integrative medicine” (IM), which has over the last few years nearly supplanted the former term used for non-science-based medicine or medicine based on prescientific ideas represented as though it were scientific medicine, “complementary and alternative medicine” (CAM). Indeed, just last week I pointed out how IM is far more about marketing than it is about science or medicine, and over the last three years I’ve been particularly harsh on the concept of “integrative oncology,” which is actually being represented as a “subspecialty” of IM. Despite the utter lack of a rationale based on science or the scientific basis of medicine, IM has still been making inroads into academic medical centers, where I tend to refer to it with the unapologetically disparaging term “quackademic medicine.” Even worse, now, increasingly, such woo has been insinuating its way into community medical centers as well.

Arguably, the man who has done more than any individual to promote the quackification of science-based medicine is Dr. Andrew Weil. (At least, I can’t think of any single person who’s done more during his lifetime to promote the infiltration of quackery into medicine. Readers are free to chime in if they know of someone who could challenge Weil for the title of King of Quackademic Medicine.) As I pointed out the last time I discussed him, Dr. Weil doesn’t really like science-based medicine. Oh, no, he doesn’t like it at all. Unfortunately, he’s been very successful in promoting quackademic medicine. He’s also arguably been the single most successful person at legitimizing what used to be viewed as quackery. Master of the domain of “integrative medicine,” having formed a model of an “integrative medicine in residency” that’s spread like kudzu through quackademia, all from his redoubt at the University of Arizona, Dr. Weil has now announced his intention for the next phase of his “integrating” pseudoscience with SBM. I learn this from The Integrator Blog, which has as a recent headline from last week Special Report: “Strategic Change in Direction” as Weil’s Arizona Center Commits to Creation of American Board of Integrative Medicine:

In a major strategic shift, the University of Arizona Center for Integrative Medicine (ACIM) has announced that it will lead the creation of a formal specialty for medical doctors in integrative medicine. ACIM, founded by Andrew Weil, MD and directed by Victoria Maizes, MD, is in dialogue with the American Board of Physician Specialties toward establishing an American Board of Integrative Medicine. They are collaborating with leaders of the American Board of Integrative and Holistic Medicine (ABIHM). Here is the ACIM announcement, a statement from two ABIHM leaders, a brief interview with Maizes and the list of 18 founding Board members. Is this the right strategic choice? What impact will this have on integrative medicine and the broader integrative healthcare movement?

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Posted in: Medical Academia, Politics and Regulation

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Survey says, “Hop on the bandwagon of ‘integrative medicine’!”

A Brief Clinical Vignette

In researching this post, I found an article published nearly two years ago in The Hospitalist entitled Growth Spurt: Complementary and alternative medicine use doubles, which began with this anecdote:

Despite intravenous medication, a young boy in status epilepticus had the pediatric ICU team at the University of Wisconsin School of Medicine and Public Health in Madison stumped. The team called for a consult with the Integrative Medicine Program, which works with licensed acupuncturists and has been affiliated with the department of family medicine since 2001. Acupuncture’s efficacy in this setting has not been validated, but it has been shown to ease chemotherapy-induced nausea and vomiting, as well as radiation-induced xerostomia.

Following several treatments by a licensed acupuncturist and continued conventional care, the boy’s seizures subsided and he was transitioned to the medical floor. Did the acupuncture contribute to bringing the seizures under control? “I can’t say that it was the acupuncture — it was probably a function of all the therapies working together,” says David P. Rakel, MD, assistant professor and director of UW’s Integrative Medicine Program.

The UW case illustrates both current trends and the constant conundrum that surrounds hospital-based complementary medicine: Complementary and alternative medicine’s use is increasing in some U.S. hospitals, yet the existing research evidence for the efficacy of its multiple modalities is decidedly mixed.

My jaw dropped in horror when I read this story. Acupuncture for status epilepticus? There’s no evidence that it works and no scientific plausibility suggesting that it might work. And what does the questionable research suggesting that acupuncture might ease chemotherapy-induced nausea and vomiting or radiation-induced xerostomia (which, if you look more closely at the studies, it almost certainly does not, but that’s a post for another time) have to do with this case, anyway? Nothing. Worse, Dr. Rakel fell for the classic post hoc ergo propter hoc fallacy; i.e., despite his disclaimer, he appears to be implying that, because the child recovered, acupuncture must have contributed to his recovery. He also repeats the classic fallacy that I’ve written about time and time again in the context of cancer therapy, namely that if a patient is using quackery as well as science-based medicine, then either it was the quackery that cured him or the quackery somehow made the conventional medical care work better.

I expect better from an academic medical center like the University of Wisconsin. Unfortunately, increasingly I’m not getting it. Quackademic medicine is infiltrating such medical centers like kudzu.
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Posted in: Faith Healing & Spirituality, Medical Academia, Science and the Media

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Chemotherapy doesn’t work? Not so fast…

“CHEMOTHERAPY DOESN’T WORK!!!!!”

“CHEMOTHERAPY IS POISON!!!!”

“CHEMOTHERAPY WILL KILL YOU!!!!”

I’ve lost count of how many times I’ve come across statements like the ones above, often in all caps, quite frequently with more than one exclamation point, on the websites of “natural healers,” purveyors of “alternative medicine.” In fact, if you Google “chemotherapy doesn’t work,” “chemotherapy is poison,” or “chemotherapy kills,” you’ll get thousands upon thousands of hits. In the case of “chemotherapy kills,” Google will even start autofilling it to read “chemotherapy kills more than it saves.” The vast majority of the hits from these searches usually come from websites hostile to science-based medicine. Examples include Mercola.com, the website of “alternative medicine entrepreneur” Dr. Joe Mercola and NaturalNews.com, the website of Mike Adams, where you will find cartoons like this one, which likens the administration of chemotherapy to a Nazi death camp:

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Posted in: Cancer, Science and Medicine

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Quoth the anti-vaccine group SANE Vax: Beware HPV DNA in Gardasil!

Every so often, there’s a bit of misinformation that starts spreading around the Internet that shows up in enough places that our readers take notice and e-mail us about it. What happens is that these in essence become “requests.” We at SBM are, of course, happy to consider all requests and sometimes will actually take them on, particularly when doing so will be educational about the mission of this blog, namely discussing science-based medicine and providing much needed critical analysis to the pseudoscience that is, alas, becoming more and more common in medicine. A frequent topic of this blog is, not surprisingly, the anti-vaccine movement, which is arguably the most dangerous (to public health, at least) pseudoscience movement currently in existence. The misinformation about vaccines that anti-vaccine activists spread through websites, podcasts, radio, TV, and other media is protean, and it’s difficult to keep up with it all.

Which is probably why I hadn’t heard this bit of misinformation about the HPV vaccine from an anti-vaccine group I hadn’t heard of before (or at least didn’t remember) called SANE Vax. (I include the “Inc.” because SAFE Vax, Inc. itself insists on using it frequently in all its press releases.) If you’ve been in the biz a while, as I have, you can tell right away from the very name of this website exactly where its creators are coming from. Here’s a hint. It’s not the mission that the website claims that it is, which is stated thusly:
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Posted in: Science and Medicine, Vaccines

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Seven Deadly Medical Hypotheses revisited

Back in February, Mark Crislip and I both deconstructed an article written by Dr. Reynold Spector that appeared in the March/April issue of Skeptical Inquirer (SI), the flagship publication for the Committee for Skeptical Inquiry (CSI). The article was entitled Seven Deadly Medical Hypotheses, and, contrary to the usual standard of articles published in SI, it used a panoply of spin, bad arguments, and, yes, misinformation to paint a picture of seven horrifically deadly “medical hypotheses,” most of which, even if the reader accepted Dr. Spector’s arguments at face value in a worst case scenario, weren’t actually all that deadly at all, with the alleged deadliness of the others being in dispute. In addition, Dr. Spector painted a picture of medical science that is not nearly rigorous enough. While we at SBM would probably agree that much of medical science is insufficiently rigorous, given how so-called “complementary and alternative medicine” (CAM) or “integrative medicine” (IM) has found a prominent place in medical practice in all too many academic and private medical centers, Dr. Spector got it so wrong that he wasn’t even wrong when he conflated preliminary, hypothesis-generating studies with the big, randomized, phase III clinical trials necessary to achieve FDA approval for a new drug or device. This latest article by Dr. Spector seemed to be of a piece with his previous article in the January/February 2010 issue of SI entitled The War on Cancer A Progress Report for Skeptics, which was so negative in its assessment of scientific progress against cancer that for a moment I was wondering if I were reading NaturalNews.com or Mercola.com.

Unfortunately, Seven Deadly Medical Hypotheses itself is not yet online on the CSI website; so readers without a subscription to SI cannot at the present time judge for themselves whether Mark and I were too harsh on Dr. Spector, but our criticisms, along with that of SBM partner-in-crime Harriet Hall, did have an impact. Seemingly genuinely stunned at the level of criticism leveled at an article published in SI, SI’s editor Kendrick Frazier, to his credit, invited several responses to Dr. Spector’s article, which Harriet Hall, Mark Crislip, Carol Tavris, Avrum Bluming, and I eagerly provided. These letters were originally scheduled to be published a couple of issues ago, along with Dr. Spector’s response. Unfortunately, publishing in dead tree media being what it is, Harriet Hall and I were disappointed to find that the latest issue of SI still didn’t contain our rebuttals. Fortunately, Mr. Frazier has posted this material online for your edification, although, again, I wish he had also published the original article as well.
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Posted in: Cancer, Clinical Trials, Science and Medicine

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The College of Physicians and Surgeons of Ontario’s muddled draft policy on “non-allopathic” medicine

Detroit is my hometown, and three and a half years ago, after nearly twenty years away wandering between residency, graduate school, fellowship, and my first academic job, I found myself back in Detroit minted as surgical faculty at Wayne State University and practicing and doing research at the Barbara Ann Karmanos Cancer Institute. One thing that I had forgotten about while I was away for so many years is just how intimately southeast Michigan interacts with Canada. This closeness is not surprising, given that Detroit and Windsor are separated by only about a half mile of Detroit River. Indeed, a there are a lot of Canadians who cross the border on a daily basis to work in the Detroit area, many of them in the medical center within which my cancer center is located. The reason I point this out is not to wax nostalgic for trips to Windsor or for the occasional trip to Stratford to see plays but to point out that Ontario is right next to us. What happens there is of concern to me because I know quite a few people who live there and because it can on occasion influence what goes on over here on the U.S. side of the border.

I recently learned that the College of Physicians and Surgeons of Ontario (CPSO) has been working on updating its policy on the use of nonconventional medical therapies. The wag in me can’t help but wonder why such a policy would need to say anything other than that, if it isn’t science- and evidence-based, the CPSO doesn’t support using it, but in a less sarcastic moment I realized that such a policy is probably not that bad an idea, as long as it doesn’t legitimize pseudoscience, which is, of course, the biggest pitfall to be avoided when writing such a policy. Not too long ago, the CPSO released its draft policy and has asked for public comments, with the deadline being September 1. I was happy to learn that I had not missed the deadline, because there is much to comment about regarding this policy, but it’s definitely true that time’s short. Unfortunately, I wasn’t so happy when I read the title of the draft policy, namely Non-Allopathic (Non-Conventional) Therapies in Medical Practice, with a subtitle of “Formerly named Complementary Medicine.” The full policy in PDF form can be found at this link.
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Posted in: Homeopathy, Politics and Regulation, Public Health

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“Integrative medicine”: A brand, not a specialty

Author’s note: This post was inspired in part by a post by Wally Sampson entitled Why would medical schools associate with quackery? Or, How we did it.

PRELUDE

Once upon a time, there was quackery.

Long ago, back in the mists of time before many of our current readers were even born and far back in the memory of even our wizened elders of medicine, “quackery” was the preferred term used to refer to ineffective and potentially harmful medical practices not supported by evidence. Physicians, having a grounding in science and prior plausibility, for the most part understood that modalities such as homeopathy, reflexology, and various “energy healing” (i.e., faith healing) methodologies were based either on prescientific vitalism, magical thinking, and/or science that was at best incorrect or at the very least grossly distorted. More importantly, physicians weren’t afraid to call quackery quackery, quacks quacks, and charlatans charlatans.

Not surprisingly, quacks and charlatans did not like this.
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Posted in: Homeopathy, Science and Medicine, Science and the Media

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Revisiting Daniel Moerman and “placebo effects”

About three weeks ago, ironically enough, right around the time of TAM 9, the New England Journal of Medicine (NEJM) inadvertently provided us in the form of a new study on asthma and placebo effects not only material for our discussion panel on placebo effects but material for multiple posts, including one by me, one by Kimball Atwood, and one by Peter Lipson, the latter two of whom tried to point out that the sorts of uses of these results could result in patients dying. Meanwhile, Mark Crislip, in his ever-inimitable fashion, discussed the study as well, using it to liken complementary and alternative medicine (CAM) as the “beer goggles of medicine,” a line I totally plan on stealing. The study itself, we all agreed, was actually pretty well done. What it showed is that in asthma a patient’s subjective assessment of how well he’s doing is a poor guide to how well his lungs are actually doing from an objective, functional standpoint. For the most part, the authors came to this conclusion as well, although their hedging and hawing over their results made almost palpable their disappointment that their chosen placebos utterly failed to produce anything resembling an objective response improving lung function as measured by changes (or lack thereof) in FEV1.

In actuality, where most of our criticism landed, and landed hard—deservedly, in my opinion—was on the accompanying editorial, written by Dr. Daniel Moerman, an emeritus professor of anthropology at the University of Michigan-Dearborn. There was a time when I thought that anthropologists might have a lot to tell us about how we practice medicine, and maybe they actually do. Unfortunately, my opinion in this matter has been considerably soured by much of what I’ve read when anthropologists try to dabble in medicine. Recently, I became aware that Moerman appeared on the Clinical Conversations podcast around the time his editorial was published, and, even though the podcast is less than 18 minutes long, Moerman’s appearance in the podcast provides a rich vein of material to mine regarding what, exactly, placebo effects are or are not, not to mention evidence that Dr. Moerman appears to like to make like Humpty-Dumpty in this passage:
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Posted in: Acupuncture, Basic Science, Clinical Trials, Neuroscience/Mental Health, Science and the Media

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Answering another criticism of science-based medicine

In the three and a half years that the Science-Based Medicine blog has existed, we contributors have come in for our share of criticism. Sometimes, the criticism is relatively mild; often it’s based on a misunderstanding of what SBM is; but sometimes it’s quite nasty. I can’t speak for the rest of the SBM crew on this, but I’ve gotten used to it. It comes with the territory, and there’s little to do about it other than to skim each criticism as it comes in to see if the author makes any valid points and, if he doesn’t, to ignore it and move on. Indeed, there’s enough criticism being flung our way that I rarely respond directly anymore. Exceptions tend to be egregious examples, incidents that spark real problems, such as when Age of Autism blogger and anti-vaccine activist Jake Crosby tried to paint me as being hopelessly in the thrall of big pharma, which resulted in the anti-vaccine horde who read that blog to try to get me fired by sending complaints to the Board of Governors at my university and the dean of my medical school. Other examples tend to be what I call “teachable moments,” in which the mistakes made in the criticism provide fodder for making a point about SBM versus alternative medicine, “complementary and alternative medicine” (CAM), or “integrative medicine” (IM)—or whatever the nom du jour is.

File this next one under the “teachable moment” variety of criticism directed at SBM.
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Posted in: Basic Science, Clinical Trials, Science and Medicine

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