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Dr. Donald Berwick and “patient-centered” medicine: Letting the woo into the new health care law?

There’s been a bit of buzz in the health blogs over President Obama’s decision last week to use the mechanism of a recess appointment to be the director of the Centers for Medicare and Medicaid Services (CMS). Recess appointments, for those who may not be aware, allow a President to put a nominee in place when Congress is in recess in order to have him in place without the messy process of having him approved by the Senate. True, the Senate still has to approve a recess appointment by the end of its term, or the seat goes vacant again, but it’s an excellent way to avoid having nasty confirmation fights during election years. Of course, both parties do it, and the reaction of pundits, bloggers, and politicians tend to fall strictly along partisan lines. If you support the President, then a recess appointment is a way to get around the obstructionism of the other party. If you don’t support the President, it’s a horrific abuse of Presidential power. And so it goes. Either way, I don’t really care much about the politics of how such officials are appointed so much as who is being appointed.

The man who was appointed last week to head CMS is Donald Berwick, M.D., CEO of the Institute for Healthcare Improvement. His being placed in charge of CMS will likely have profound consequences not just for how the recent health care/insurance reform law is implemented but for how the government applies science-based medicine to the administration of the this massive bill. Most of the criticism of his views that I’ve seen thus far comes from conservatives, who do not like Berwick’s apparent penchant for health care systems like the British NHS. Ironically, it’s views held by Berwick that will likely come into direct conflict with his mandate to hold down costs that are the problem with Dr. Berwick, at least to me. It is in these views where there is much that is admirable. Unfortunately, I also fear that there is much about Berwick’s views that are very friendly to the possibility of allowing the infiltration of woo into the U.S. health care system as well, and these fears begin with what Berwick is most known for, a term he calls “patient empowerment.”

What a grand word! After all, who doesn’t want to be “empowered”? Certainly not me. Perhaps that’s the reason why it’s become the new buzzword in a movement known as “patient-centered” care. Old fart that I am, when I first encountered the term I was a bit puzzled by exactly what “patient empowerment” means. After all, I’ve always thought I have been practicing patient-centered care, ever since my first days in medical school. Apparently these days it means something different, at least if this article from about a year ago in the New York Times is any indication. It’s an interview with Dr. Donald Berwick, who advocates what he himself calls a “radical” patient-centered care, having at the time recently published an article in Health Affairs entitled What ‘Patient-Centered’ Should Mean: Confessions Of An Extremist. It was unclear to me then and it’s unclear to me now whether Berwick was being sarcastic or flippant in his characterization of himself as an “extremist.”
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Posted in: Politics and Regulation, Public Health, Science and the Media

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Homeopathy in the ICU?

ResearchBlogging.orgEditor’s note: It’s still a holiday weekend in the United States. I had considered simply taking the day off altogether, particularly since I’m busily working on my talk for TAM8–which (holy crap!) is in a mere three days–but then I figured today’s a good time to resurrect a “classic” (if you will) post that I wrote a few years ago, dust it off, and post it. I decided to do this mainly because I had been planning on bringing this post to SBM at some point right from the very beginning of SBM.

Regular readers of this blog are probably familiar with a certain homeopath named Dana Ullman. So persistent is he in his pseudoscientific arguments for the magic that is homeopathy that fellow SBM blogger Kimball Atwood once postulated a humorous law he dubbed the Dull-Man Law:

In any discussion involving science or medicine, being Dana Ullman loses you the argument immediately…and gets you laughed out of the room.

Kimball then pointed to a number of studies that Ullman likes to cite ad nauseam that supposedly “prove” the efficacy of homeopathy. One study Kimball didn’t mention, however, is a favorite of Ullman’s, one he likes to trot out time and time again. Specifically, it’s a study of homeopathy in the ICU that was published, in all places, in Chest, a respectable journal that, as you might expect, is dedicated to research on diseases of the chest, such as chronic obstructive pulmonary disease (COPD), cardiac disease, and basically any disease that manifests its pathology in the chest, although it primarily deals with critical care. I first learned of this study way back in 2007 from Dr. R. W., who at the time commented quite aptly that the article impressed him with just how far into the medical mainstream woo has penetrated, while retired doc also expressed his dismay.

Although I do feel a bit guilty not providing you with more original peerless prose pontificating on medical pseudoscience that you know and (hopefully) love, this article is constantly trotted out by homeopaths, even five years later, and that makes it worth updating an older post from another source. So here’s the abstract:
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Posted in: Clinical Trials, Homeopathy

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The price of opposing medical pseudoscience

EDITOR’S NOTE: This post is a followup to a post from two weeks ago entitled In which Dr. Gorski once again finds himself a target of the “pharma shill” gambit. If you haven’t read that post before, you might want to go back and read it now before proceeding with this post. Please also note the disclaimer.

I want to beg your indulgence this week, hoping that my history as a blogger here on SBM and then as managing editor allows me that. Today’s post will be a little different because last week was really, really, hectic. First and foremost, I was busy writing a preapplication for a Susan J. Komen Foundation grant for a deadline of last Friday. The Komen Foundation, it turns out, has changed its procedures this year so that the preapplication is now evaluated much more rigorously. It’s no longer looked at just to make sure that the proposed project matches the subject matter and criteria for the request for applications (RFA). This year, the preapplication actually matters! Moreover, it’s so long that writing it is practically like writing the entire grant, other than the budget. But I got it done, and it looks pretty good, if I do say so myself. None of that is any guarantee that Komen will invite us to submit a full application, but I’m hopeful because if it does we should have a good shot at the grant.

Then, this weekend I had to pivot on a dime and return to writing the R01 I had been working on with my collaborator. To make the July resubmission deadline, it has to be done, in the can, and submitted by this Friday. In any case, these are the reasons why this post is likely to be uncharacteristically personal in nature.

Oh, those reasons plus a little bit of character assassination launched at me on Monday by Jake Crosby over at the Age of Autism, entitled David Gorski’s Financial Pharma Ties: What He Didn’t Tell You.
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Posted in: Medical Academia, Neuroscience/Mental Health, Vaccines

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Cancer Treatment Centers of America and “naturopathic oncology”

EDITOR’S NOTICE: NOTE THE DISCLAIMER.

On “wholistic” medicine

If there’s one aspect of so-called “alternative medicine” and “complementary and alternative medicine” (CAM) is that its practitioners tout as being a huge advantage over what they often refer to sneeringly as “conventional” or “scientific” medicine is that — or so its practitioners claim — alt-med treats the “whole patient,” that it’s “wholistic” in a way that the evil reductionist “Western” science-based medicine can’t be. Supposedly, we reductionistic, unimaginative physicians only focus on disease and ignore the “whole patient.” Of course, to me this claim is belied by the hectoring to which my own primary care physician has subjected me about my horrible diet and lack of exercise on pretty much every visit I’ve had with her, but then maybe she’s an anomaly, along with Dr. Lipson on this very blog and pretty much every other primary care doctor I’ve ever dealt with. Anecdotal experience, I know, but since alt-med mavens appear to value anecdotal evidence above pretty much all else I thought it appropriate to mention here. Also belying the claim of alt-med practitioners that they “individualize” treatments to their patients in a way that science-based medicine does not is the maddening tendency of various alt-med modalities to settle on just One True Cause of All Disease, be it liver flukes as the One True Cause of Cancer, heavy metal toxicity as the One True Cause of cancer, autism, and various other diseases, or “allergies,” acid, or obstruction of the flow of qi as the One True Cause of All Disease.

Given the claim of “wholism” that is such an advertising gimmick among many of the varieties of woo, I’m always interested when I see evidence that alt-med is imitating its envied and disliked reductionistic competition. True, this is nothing new, given how alt-med has tried to seek legitimacy by taking on the mantle of science-based medicine wherever it can. Examples include the National Center for Complementary and Alternative Medicine (NCCAM), various organizations that try to confer legitimacy to pseudoscience by providing “certification” in various flavors of woo, and moves to push state medical boards to go further than that and confer legally protected status to practitioners by actually licensing them. This latter tactic has been very successful in that many states now license acupuncturists, while some states even license naturopaths and “homeopathic physicians,” the latter of which I find quite amusing because the term perfectly encapsulates what must remain of such a physician’s medical training after being diluted to 30C with woo. The only difference is that, unlike what is claimed with homeopathy, diluting MD medical knowledge with woo does not make it stronger. In terms of naturopathy, though, one of the most alarming aspects of the infiltration of naturopaths into the health care system is that some states in the U.S. and provinces in Canada are seriously considering allowing them to prescribe real pharmaceutical medications, even though they lack the training and knowledge to use such drugs safely.

Imagine my combination of bemusement and alarm, then, when I learned of a new specialty of pseudoscience, namely the field of naturopathic oncology.

Be afraid. Be very afraid. (I know I was when I first encountered this specialty.)
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Posted in: Cancer, Chiropractic, Homeopathy, Science and Medicine

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The genetics of autism

Autism and autism spectrum disorders (ASDs) actually represent a rather large continuum of conditions that range from very severe neurodevelopmental delay and abnormalities to the relatively mild. In severe cases, the child is nonverbal and displays a fairly well-characterized set of behaviors, including repetitive behaviors such as “stimming” (for example, hand flapping, making sounds, head rolling, and body rocking.), restricted behavior and focus, ritualistic behavior, and compulsive behaviors. In more mild cases, less severe compulsion, restriction of behavior and focus, and ritualistic behaviors do not necessarily preclude functioning independently in society, but such children and adults may have significant difficulties with social interactions and communication. Because ASDs represent a wide spectrum of neurodevelopmental disorders whose symptoms typically first manifest themselves to parents between the ages of two and three, the idea that vaccines cause autism and ASDs has been startlingly difficult to dislodge and has fueled an anti-vaccine movement, both here in the U.S. and in other developed nations, particularly the U.K. and Australia. This movement has been stubbornly resistant to multiple scientific studies that have failed to find any link between vaccines in autism or the other favorite bogeyman of the anti-vaccine movement, the mercury-containing thimerosal preservative that used to be in many childhood vaccines in the U.S. until the end of 2001. Add to that the rising apparent prevalence of ASDs, and, confusing correlation with causation, the anti-vaccine movement concludes that vaccines must be the reason for the “autism epidemic.”

In reality, autism and ASDs appear to be increasing in prevalence due to diagnostic substition, better screening, and the broadening of the diagnostic criteria that occurred in 1994. Autism prevalence does not appear to be rising, at least not dramatically, at all, as the prevalence of ASDs, when assessed carefully, appears to be similar in adults as it is in children. If the true prevalence rate of autism and ASDs has increased, it has not increased by very much. In reality autism appears to have a major and probably predominant genetic component, and several scientific studies over the last few years have linked autism with various genetic abnormalities. Not surprisingly, given the varied presentation and severity of ASDs, these studies have not managed to identify single genes that produce autism or ASDs with a high degree of penetrance (probability of causing the phenotype if the gene is present). Indeed, one can argue that the state of current evidence is that ASDs are due to multiple genes, perhaps dozens or hundreds. Again, this is not surprising given the heterogeneity of ASD severity, presentation, and symptoms.

One of the more surprising studies supporting a genetic basis for autism appeared to much fanfare in Nature last week. The study by Pinto et al, looks at the functional impact of global rare copy number variation in autism spectrum disorders. Its results are rather surprising in that the large team of investigators (studies of this type take a lot of people to carry out) found that it may be relatively uncommon copy number variations in various genes that lead to the phenotype of autism or ASDs.
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Posted in: Neuroscience/Mental Health, Science and Medicine, Vaccines

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In which Dr. Gorski once again finds himself a target of the “pharma shill” gambit

EDITOR’S NOTICE: NOTE THE DISCLAIMER. Also note that there is a followup to this post entitled The price of opposing medical pseudoscience that is highly recommended after you read this post.

The “pharma shill gambit”: The quack’s favorite flavor of ad hominem argument

One of the very favorite and most commonly used tactics to attack criticism in the armamentarium of pseudoscientists, cranks, and quacks (not to mention politicians) is the ad hominem fallacy. In this fallacy, rather than addressing the actual evidence and science that demonstrate their favorite brand of woo to be nothing more than fairy dust, the idea is to preemptively attack and discredit the person. The ad hominem is not just insults or concluding that someone is ignorant because, well, they say ignorant things and make stupid arguments (in which case calling someone stupid or ignorant might just be drawing a valid, albeit impolitic, conclusion from observations of that person’s behavior), but rather arguing or insinuating that you shouldn’t accept someone’s arguments not because their arguments are weak but because they have this personal characteristic or that or belong to this group or that. Truly, the ad hominem is right up there with demanding public “debates” with skeptics as a favored defense strategy of cranks of all stripes.

Among the very favorite flavors of ad hominem attack used by quacks, cranks, and pseudoscientists is the fallacy of poisoning the well. This particular fallacy alludes to the medieval European myth that the Black Plague was caused by Jews poisoning town wells. Not surprisingly, this myth was used as a justification for pogroms and the persecution of the Jews. The idea is to poison how others view your opponent by preemptively attacking them. Well do I know this fallacy, having been at the receiving end of it many times! Basically, it involves invoking something bad or biased about a person’s situation or personality and then using a phrase something like, “Of course he (or she) would say that” to dismiss a person’s arguments, the implication being that the person receives such benefits from holding the position being attacked or has such a personality that he couldn’t argue otherwise regardless of the evidence. In my admittedly anecdotal experience, far and away the most common use of the ad hominem from quacks and pseudoscientists is what I once described as “the pharma shill gambit.” The idea behind this gambit when it comes to attacking those of us who promote science-based medicine is to tar one’s opponent as being a “shill” for big pharma or claiming that we have a conflict of interest so blatant that “of course we would say that.” In most cases, the bogey man is big pharma, in whose pockets we SBM bloggers are supposed to be safely (and profitably) ensconced, blogging away in our underwear for big bucks and, following the orders of our supposed paymasters, attacking anything that has even a whiff of being “alternative” or that “questions” the safety and/or efficacy of vaccines.

While I realize that there is such a thing as an “astroturf” campaign, in the vast majority of cases, the pharma shill gambit is nothing more than the variant of the ad hominem fallacy known as poisoning the well. I also realize that conflicts of interest (COIs) matter, particularly undisclosed COIs. Indeed, I wrote a rather lengthy post (I know, I know, do I write any other length of post?) about 8 months ago laying out my views regarding COIs in science-based medicine. The short version is that we all have COIs of some sort or another, be they financial, belief-based, or emotional, and more disclosure is usually better, to let the reader decide for himself. As far as COIs related to big pharma or finances, I think Mark Crislip put it quite well in his most recent Quackcast when he said that if a study is funded by big pharma, he decreases the strength of the evidence in his mind by a set amount. However, evidence is evidence, and, although it is reasonable to increase one’s level of skepticism if there is a major COI involving the authors, be it big pharma or otherwise, it is not reasonable to use that COI as the sole reason for rejecting its findings out of hand. That’s just an intellectually lazy excuse to dismiss the study, nothing more. Indeed, one prominent difference between a scientist and a pseudoscientist or quack is that in general scientists understand this and struggle to assign the correct degree of skepticism due to a COI when analyzing scientific studies, while quacks and pseudoscientists do not. It’s far easier for them just to put their fingers in their ears and scream “Conflict of interest! Conflict of interest!” and then use that to dismiss completely their opponent’s argument. It’s simple, neat, and it doesn’t require all that nasty thinking and weighing of evidence..
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Posted in: Medical Ethics, Neuroscience/Mental Health, Public Health, Vaccines

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Certainty versus knowledge in medicine

I don’t want knowledge. I want certainty!

— David Bowie, from Law (Earthlings on Fire)

If there’s a trait among humans that seems universal, it appears to be an unquenchable thirst for certainty. It is likely to be a major force that drives people into the arms of religion, even radical religions that have clearly irrational views, such as the idea that flying planes into large buildings and killing thousands of people is a one-way ticket to heaven. However, this craving for certainty isn’t expressed only by religiosity. As anyone who accepts science as the basis of medical therapy knows, there’s a lot of the same psychology going on in medicine as well. This should come as no surprise to those committed to science-based medicine because there is a profound conflict between our human desire for certainty and the uncertainty that is always inherent in so much of our medical knowledge. The reason is that the conclusions of science are always provisional, and those of science-based medicine arguably even more so than many other branches of science.

In fact, one of the hardest things for many people to accept about science-based medicine is that the conclusions of science are always subject to change based on new evidence, sometimes so much so that even those of us “in the biz” can become a bit disconcerted at the rate at which knowledge we had thought to be secure changes. For example, think of how duodenal peptic ulcer disease was treated 25 years ago and then think about how it is treated now. Between 1984 and 1994, a revolution occurred on the basis of the discovery of H. pylori as the cause of most of the gastric and peptic ulcer disease we see. Where in 1985 we treated PUD with H2-blockers and other drugs designed to block gastric acid secretion, now antibiotics represent the mainstay of treatment and are curative at a much higher success rate than any treatment other than surgery and without the complications of surgery. I’m sure any other physician here could come up with multiple other examples. In my own field of breast cancer surgery, I look back at how we treated breast cancer 22 years ago, when I first started residency, and how we treat it now, and I marvel at the changes. If such changes can be disconcerting even to physicians dedicated to science-based medicine, imagine how much more disconcerting they are to lay people, particularly when they hear news reports of one study that produces one result, followed just months later by a report of a different study that gives a completely different result.
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Posted in: Diagnostic tests & procedures, Medical Academia, Neuroscience/Mental Health

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Another overhyped acupuncture study misinterpreted

acupinhead

Perhaps the most heavily studied of “alternative medicine” modalities is acupuncture. Although it’s hard to be sure as to the reason, I tend to speculate that part of the appeal to trying to do research in this area is because acupuncture is among the most popular of actual “alt-med” modalities, as opposed to science-based medical modalities co-opted by believers in alt-med and rebranded as “alternative” (diet and exercise, for instance, to which is all too often added the consumption of huge quantities of unproven nutritional supplments) or activities that make people feel better, whether they’re healthy or ill (massage, for instance). In contrast, acupuncture involves actually sticking needles into the skin. Never mind that the rationale for acupuncture, namely “redirecting” the flow of the “life energy” known as qi when it is blocked by sticking needles in “meridians” like some electrodes in some imaginary qi battery, is pure bunkum, as we’ve pointed out here at SBM time and time again. Somehow the image of needles sticking out of the skin, apparently painlessly and making some extreme acupuncture practices resemble Pinhead from the Hellraiser movie series, seems “sexy” as far as “alternative” therapies go, particularly since it’s “Eastern” as opposed to that reductionistically evil “Western medicine,” and, as we all know at SBM, “Western” is bad and “Eastern” is good.

So the fascination with acupuncture remains, so much so that an inordinate amount of research dollars are spent on studying it. Unfortunately, that money is largely wasted. As Steve Novella has pointed out, in general in medicine (at least these days), the trajectory of research is usually from bench research to animal models to small scale, less rigorous, pilot studies in humans to large scale, rigorously designed studies using many subjects. True, this order doesn’t always hold. For instance, if physicians make a compelling observation “at the bedside” of response to therapy or how a disease progresses, frequently, after making closer observations to confirm the initial observation, researchers will jump back to animal models and bench top research to try to figure out what’s going on. For such a progression to be useful, though, scientists have to be sure that the phenomenon in human patients under study actually exists.

Unfortunately, in acupuncture, the evidence is still unconvincing that there is any “there” there in that acupuncture effects appear to be no greater than placebo effects. As larger, more well designed studies using real placebo or sham acupuncture techniques, have increasingly shown that acupuncture does not function any better than placebo in human beings (and sometimes even worse), acupuncturists and acupuncture believers have been reversing the usual order of things, doing smaller studies and “pragmatic” (i.e., uncontrolled) clinical trials, where the placebo effect is not controlled for. Never mind that it doesn’t matter where the needles are placed (thus blowing the whole “meridian” idea out of the water) or even if the needles puncture the skin. Toothpicks work just as well as needles. Also never mind that the mythology of acupuncture as having been routinely practiced for over two thousand years (or, sometimes, four thousand years, is largely a creation of Chairman Mao, who elevated what was a marginal practice at the time to a modality that the state supported and promoted (1,2,3,4). Unfortunately, even the National Center for Complementary and Alternative Medicine (NCCAM) falls for this mythology.

Every so often, I’m amazed when an acupuncture study ends up in a high impact journal like Nature Neuroscience. Of course, when I read such articles, virtually inevitably I discover that what is being studied is not really “acupuncture” per se, but rather sticking needles into either people or animals. Sometimes, “electroacupuncture” (which is in reality not acupuncture at all, given that there was no source of electricity hundreds of years ago in China when acupuncture was supposedly invented) is misrepresented as acupuncture. Since a bunch of readers, both here and at my other blog, have deluged my mail box with this particular study, I felt obligated to have a look at it, even if Steve Novella has already weighed in with his excellent deconstruction. This particular study is especially annoying, because it’s been hyped to the nth degree, and even some news sources where the reporters should know better have fallen for it.
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Posted in: Acupuncture, 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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