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A holiday round in the mammography debate

There are times when the best-laid blogging plans of mice and men often go awry, and this isn’t always a bad thing. As the day on which so many Americans indulge in mass consumption of tryptophan-laden meat in order to give thanks approached, I had tentatively planned on doing an update on Stanislaw Burzynski, given that he appears to have slithered away from justice yet again. Then what to my wondering eyes should appear in my e-mail in box but news of a study that practically grabbed me by my collars, shook me, and demanded that I blog about it. As if to emphasize the point, suddenly e-mails started appearing by people who had seen stories about the study and, for reasons that I still can’t figure out after all these years, were interested on my take on the study. Yes, I realize that I’m a breast cancer surgeon and therefore considered an expert on the topic of the study, mammography. I also realize that I’ve written about it a few times before. Even so, it never ceases to amaze me, even after all these years, that anyone gives a rodential posterior about what I think. Then I started getting a couple of e-mails from people at work, and I knew that Burzynski had to wait or that he would be relegated to my not-so-secret other blog (I haven’t decided yet).

As is my usual habit, I’ll set the study up by citing how it’s being spun in the press. My local home town paper seems as good a place to begin as any, even though the story was reprinted from USA Today. The title of its coverage was Many women receiving unnecessary breast cancer treatment, study shows, with the article released the day before the study came out in the New England Journal of Medicine:
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Posted in: Cancer, Diagnostic tests & procedures, Public Health

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Getting NCCAM’s money’s worth: Some results of NCCAM-funded studies of homeopathy

As hard as it is to believe, the Science-Based Medicine blog that you’re so eagerly reading is fast approaching its fifth anniversary of existence. The very first post here was a statement of purpose by Steve Novella on January 1, 2008, and my very first post was a somewhat rambling introduction that in retrospect is mildly embarrassing to me. It is what it is, however. The reason I mention this is because I want to take a trip down memory lane in order to follow up on one of my earliest posts for SBM, which was entitled The National Center for Complementary and Alternative Medicine (NCCAM): Your tax dollars hard at work. Specifically, I want to follow up on one specific study I mentioned that was funded by NCCAM.

Even though I not-so-humbly think that, even nearly five years later, my original post is worth reading in its entirety (weighing in at only 3,394 words, it’s even rather short—for me, at least), I’ll spare you that and cut straight to the chase, the better to discuss the study. It is a study of homeopathy. Yes, in contrast to the protestations of Dr. Josephine Briggs, the current director of NCCAM, that NCCAM doesn’t fund studies of such pure pseudoscience as homeopathy anymore (although she does apparently meet with homeopaths for “balance”), prior to Dr. Briggs’ tenure NCCAM actually did fund studies of the magic water with mystical memory known as homeopathy. Two grants in particular I singled out for scorn. The principal investigator for both grants was Iris Bell, who is faculty at Andrew Weil’s center of woo at the University of Arizona. The first was an R21 grant for a project entitled Polysomnography in homeopathic remedy effects (NIH grant 1 R21 AT000388).
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Posted in: Basic Science, Clinical Trials, Homeopathy

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“Moneyball,” the 2012 election, and science- and evidence-based medicine

Regular readers of my other blog probably know that I’m into more than just science, skepticism, and promoting science-based medicine (SBM). I’m also into science fiction, computers, and baseball, not to mention politics (at least more than average). That’s why our recent election, coming as it did hot on the heels of the World Series in which my beloved Detroit Tigers utterly choked got me to thinking. Actually, it was more than just that. It was also an article that appeared a couple of weeks before the election in the New England Journal of Medicine entitled Moneyball and Medicine, by Christopher J. Phillips, PhD, Jeremy A. Greene, MD, PhD, and Scott H. Podolsky, MD. In it, they compare what they call “evidence-based” baseball to “evidence-based medicine,” something that is not as far-fetched as one might think.

“Moneyball,” as baseball fans know, refers to a book by Michael Lewis entitled Moneyball: The Art of Winning an Unfair Game. Published in 2003, Moneyball is the story of the Oakland Athletics and their manager Billy Beane and how the A’s managed to field a competitive team even though the organization was—shall we say?—”revenue challenged” compared to big market teams like the New York Yankees. The central premise of the book was that that the collective wisdom of baseball leaders, such as managers, coaches, scouts, owners, and general managers, was flawed and too subjective. Using rigorous statistical analysis, the A’s front office determined various metrics that were better predictors of offensive success than previously used indicators. For example, conventional wisdom at the time valued stolen bases, runs batted in, and batting average, but the A’s determined that on-base percentage and slugging percentage were better predictors, and cheaper to obtain on the free market, to boot. As a result, the 2002 Athletics, with a payroll of $41 million (the third lowest in baseball), were able to compete in the market against teams like the Yankees, which had a payroll of $125 million. The book also discussed the A’s farm system and how it determined which players were more likely to develop into solid major league players, as well as the history of sabermetric analysis, a term coined by one of its pioneers Bill James after SABR, the Society for American Baseball Research. Sabermetrics is basically concerned with determining the value of a player or team in current or past seasons and with predicting the value of a player or team in the future.
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Posted in: Clinical Trials, Politics and Regulation, Science and Medicine, Science and the Media

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The result of the Trial to Assess Chelation Therapy (TACT): As underwhelming as expected

Chelation therapy.

It’s one of the most common quackeries out there, used by a wide variety of practitioners for a wide variety of ailments blamed on “heavy metal toxicity.” Chelation therapy, which involves using chemicals that can bind to the metal ions and allow them to be excreted by the kidneys, is actually standard therapy for certain types of acute heavy metal poisoning, such as iron overload due to transfusion, aluminum overload due to hemodialysis, copper toxicity due to Wilson’s disease, acute heavy metal toxicity, and a handful of other indications.

My personal interest in chelation therapy developed out of its use by unscrupulous practitioners who blamed autism on the mercury-containing thimerosal preservative that used to be in many childhood vaccines until 2001 but has since all but disappeared from such vaccines except for one vaccine (the flu vaccine, for which a thimerosal-free alternative is available) and in trace amounts in some other vaccines. Mercury became a convenient bogeyman to add to the list of “toxins” antivaccinationists hype in vaccines. In fact, my very first post after I introduced myself on this very blog discussed the idea that mercury in vaccines was a significant cause of autism and autism spectrum disorders, and I’ve periodically written about such things ever since, in particular the bad science of Mark and David Geier, whose idea that chemical castration of children with Lupron “works” against “mercury-induced” autism is based on a chemically ridiculous idea that somehow testosterone binds mercury and makes it harder to chelate. Unfortunately, this particular autism quackery has real consequences and has been responsible for the death of a child.

Chelation isn’t just for autism, however. Despite many practitioners advertising it for autism, cancer (often with dubious studies that I might have to take a look at), Alzheimer’s disease (which Hugh Fudenberg has blamed on the flu vaccine, a claim parroted by Bill Maher, of course!), and just about every ailment under the sun, it’s easy to forget that the original use for chelation therapy promoted by “alternative medicine” practitioners was for cardiovascular disease. When it is used for coronary artery disease or autism, on a strictly stoichiometric and pharmacological basis, it is extremely implausible. Moreover, it is not without potential complications, including renal damage and cardiac arrhythmias due to sudden drops in calcium levels. Such arrhythmias can and have led to death in children, and in adults complications such as renal failure and death.
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Posted in: Clinical Trials

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The American Medical Student Association: On “integrating” quackery with science-based medicine

There’s a saying in medicine that we frequently hear when a newer, more effective therapy supplants an older therapy or an existing therapy is shown not to be as efficacious as was once thought, and it has to do about how long it takes for the use of that therapy to decline. The saying basically says that the therapy won’t die out until the current generation of established physicians retire and are replaced by the new generation coming up through medical schools. From my perspective, it’s a bit of an exaggeration, because in the mere 13 years that I’ve been a real doctor (i.e., an attending physician) our practices in breast cancer surgery has changed markedly. Although certain core principles of breast cancer care remain the same, there have been major changes in terms of how we deal with the axillary lymph nodes, our use of hormone therapy and chemotherapy, and our very understanding of the different subtypes of breast cancer. Of course, I have spent my entire career as faculty at two different NCI-designated comprehensive cancer centers; so my experience is not representative of that of most physicians, particularly given that I’m super subspecialized. It’s generally expected that if you’re faculty in an academic medical center you will be at the very least up to date, if not beyond at the cutting edge.

Even so, there is some truth to the observation that it takes the rise of a new generation of physicians to force out certain old ideas, which means that how we train our medical students is of utmost importance. Unfortunately, these days, it is medical students who have become a major force for promoting the “integration” of quackery into medicine (which these days is known as, appropriately enough in a way unintended by its proponents, “integrative medicine”). No, I’m not saying that all or even most medical students are prone to the blandishments of quackademic medicine, but rather that there is a large enough contingent of medical students who have gone beyond being shruggies to become activists for unscientific medicine. There are CAM clubs, CAM interest groups, and student-driven CAM electives.

And then there’s the American Medical Students Association (AMSA), specifically its various initiatives in “integrative medicine.” I fear that each successive generation of medical students is more prone to embracing unscientific medicine than the last.
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Posted in: Medical Academia

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Mortality and lack of health insurance

The 2012 election campaign is in full swing, and, for better or worse, health care is one of the major defining issues of the election. How can it not be, given the passage of the Patient Protection and Affordable Care Act (PPACA), also colloquially known as “Obamacare,” was one of the Obama administration’s major accomplishments and arguably the largest remaking of the American health care system since Medicare in 1965? It’s also been singularly unpopular thus far, contributing to the Republican takeover of the House of Representatives in the 2010 elections, as well as the erosion of Democratic control of the Senate. Given that this is a medical blog dedicated to discussing the scientific basis of medicine and not a political or health policy blog, I am not going to go into the reasons for a lot of this. What I am going discuss is a recent eruption of the central problem that led President Obama to make the PPACA one of the central policy initiatives, if not the central policy initiative, of his first term. That problem is the issue of people without health insurance, who number roughly 50 million, with a further estimate that 86.7 million people were uninsured at some point during the two year period from 2007 to 2008, representing about 29% of the total U.S. population under 65.

The question that bubbled to the surface last week in the form of a statement by Republican challenger Mitt Romney, and a tear-inducing op-ed piece published yesterday in the New York Times by Nicholas Kristof entitled A Possibly Fatal Mistake, is what the health impact of not having insurance is for those millions of people. This is a question that can be addressed scientifically and is, despite its politically charged nature, correctly within the purview of science-based medicine. What to do about it, in contrast, is a matter for politics and public policy. So first let’s examine the question.
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Posted in: Politics and Regulation, Public Health

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The antivaccine lie that just won’t die: The claim that shaken baby syndrome is really due to “vaccine injury”

As I mentioned recently, as hard as it is to believe, this blog is rapidly approaching the end of its fifth year of existence. Our first post was delivered to the anxiously waiting world on January 1, 2008; so thus upcoming January 1 will represent our fifth anniversary. In the blogging world, that’s almost the equivalent of a fiftieth anniversary, given how fast most blogs turn over. Something that is even more satisfying than mere longevity is that we really have found a niche in the medical blogosphere to the point where we’ve become quite influential. People notice us. Our targets notice it when we discuss them. Sometimes even the press notices us. This is all a very good thing.

Unfortunately, even though we’ve been at this for just shy of five years, there are still topics we haven’t covered, or at least haven’t covered in sufficient depth. The topic of my post today is one of the latter topics. We’ve mentioned it before; we’ve alluded to it before (for instance when discussing the antivaccine website Medical Voices and the Ayn Rand-worshiping Association of American Physicians and Surgeons; but there hasn’t been a post dedicated to this particular topic. I find this particularly odd because it was one a piece of misinformation promoted by elements of the antivaccine movement that truly shocked and disgusted me. Before I learned of this particular myth, I was surprised to learn that there are really people who think that vaccines are dangerous and cause autism, but I viewed it as being of a piece of a lot of other quackery I was discovering at the time.

Way back in the day, when I first encountered antivaccine views in that wretched Usenet swamp of pseudoscience, antiscience, and quackery known as misc.health.alternative (m.h.a.), there was one particular antivaccine lie that disturbed me more than just about any other. As I mentioned, it wasn’t the claim that vaccines cause autism, which is more or less the central dogma of the antivaccine movement. Even ten years ago, before the series of studies that have been released since then that fail to find a hint of a whiff of causation between vaccines and autism, that wasn’t a particularly difficult myth to refute. Indeed, given newer studies, refuting that myth has only gotten easier over the years. Emblematic of how far into the depths that particular myth has been pummeled, I know it’s gotten pretty easy when even the mainstream media start to accept that the claim that vaccines cause autism is a myth and report matter-of-factly on issues such as Andrew Wakefield’s fraud and don’t give nearly as much copious and prominent media time to the likes of Jenny McCarthy. Let’s just put it this way. When the hosts of a “morning zoo”-type radio show in Salt Lake City pummel the latest antivaccine celebrity to make a fool of himself, Rob Schneider, you know that, from an informational standpoint at least, the tide appears to have turned from several years ago, when the media took this myth a lot more seriously. That’s not to say that we don’t still have a problem. After all, “philosophical” exemption rates are going up based on a lot of this sort of misinformation, but at least the media are less insistent on “telling both sides” of a science story that doesn’t really have two sides.
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Posted in: Vaccines

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Mouse “avatars”: New predictors of response to chemotherapy?

Over the years, I’ve written a lot about “personalized medicine, mainly in the context of how the breakthroughs in genomic medicine and data pouring in from the Cancer Genome Atlas is providing the raw information necessary for developing truly personalized cancer therapy. The problem, of course, is analyzing it and figuring out how to apply it. Another problem, of course, is developing the necessary targeted drugs to attack the pathways that are identified as being dysregulated in cancer cells. Oh, and there’s that pesky evolution of resistance to antitumor therapies. Indeed, most recently, the Cancer Genome Atlas is bearing fruit in breast cancer (a study that I’ve been meaning to blog about).

One problem with modeling the pathways based on next generation sequencing data and expression profiling is testing whether therapies predicted to work from these analyses actually do work without actually testing potentially toxic drugs on patients. Cell culture is notoriously unreliable as a predictor. However, there is another way that’s intriguing. Unfortunately, as intriguing as it is, it has numerous problems, and, unfortunately, it’s being prematurely marketed to patients. Although I had heard of this technique as a research tool before, I learned about its marketing to patients when I came across an article by Andrew Pollack in the New York Times entitled Seeking Cures, Patients Enlist Mice Stand-Ins. Basically, it’s about a trend in science and among patients to use custom, “personalized’ mouse xenograft models in order to do “personalized” therapy:
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Posted in: Basic Science, Cancer, Clinical Trials, Diagnostic tests & procedures

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Antivaccine versus anti-GMO: Different goals, same methods

Countering ideologically motivated bad science, pseudoscience, misinformation, and lies is one of the main purposes of this blog. Specifically, we try to combat such misinformation in medicine; elsewhere Steve and I, as well as some of our other “partners in crime” combat other forms of pseudoscience. During the nearly five year existence of this blog, we’ve covered a lot of topics in medicine that tend to be prone to pseudoscience and quackery. Oddly enough, there’s one topic that we haven’t really written much about at all, and that’s genetically modified organisms (GMOs). GMOs, as you know, are proliferating, and it’s quite worth discussing the potential and risks of this new technology, just as it is worthwhile to discuss the potential benefits versus the risks of any new technology that can impact our health, not to mention the health of the planet. Unfortunately, GMOs have become a huge political issue, and, I would argue, they have become just as prone to pseudoscience, misinformation, and bad science as vaccines, with a radical group of anti-GMO activists who are as anti-science as any antivaccinationist or quack.

Leave it to that quackery promoter to rule all quackery promoters, Mike Adams, to give me just the opportunity to show you what I mean. Over the last couple of weeks, Mike has been in a fine lather about GMOs, with multiple posts with titles such as The GMO debate is over; GM crops must be immediately outlawed; Monsanto halted from threatening humanity and The evil of Monsanto and GMOs explained: Bad technology, endless greed and the destruction of humanity. In other words, it’s a series of post with Adams’ typical hyperbole. If you were to believe him, GMOs are the product of a plot by Satan, Monsanto, big pharma, and the government, and he’s not sure which one of these is the most evil of the bunch.
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Posted in: Cancer, Genetically modified organisms (GMOs), Politics and Regulation, Public Health

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News flash! Doctors aren’t all compliant pharma drones!

There’s an oft-quoted saying that’s become a bit of a cliché among skeptics that goes something like this: There are two kinds of medicine: medicine that’s been proven scientifically to work, and medicine that hasn’t. This is then often followed up with a rhetorical question and its answer: What do call “alternative medicine” that’s been proven to work? Medicine. Of course, being the kind of guy that I am, I have to make it a bit more complicated than that while driving home in essence the same message. In my hands, the way this argument goes is that the whole concept of “alternative” medicine is a false dichotomy. There is no such thing. In reality, there are three kinds of medicine: Medicine that has been shown to efficacious and safe (i.e., shown to work); medicine that has not yet been shown to work (i.e., that is unproven); and medicine that has been shown not to work (i.e., that is disproven). So-called “complementary and alternative medicine” (CAM or, its newer, shinier name, “integrative medicine”) consists almost completely of the latter two categories.

Part of the reason why this saying and its variants have become so commonplace among those of us who support science-based medicine is that they strike at a common truth about medicine, both science-based and “alternative.” That common truth is what we here at SBM have been arguing since the very inception of this blog, namely that there must be one science-based standard of evidence for all treatments, be they “alternative” or the latest creation of big pharma. That point informs everything I write here and everything my blogging parters in crime write about too. What that means is a single, clear set of standards for evaluating medical evidence, in which clinical evidence is coupled to basic science and scientific plausibility. Indeed, one of our main complaints against CAM and its supporters has been how they invoke a double standard, in which they expect their therapies to be accepted as “working” on the basis of a much lower standard of evidence. Indeed, when they see high quality clinical trials demonstrating that, for example, acupuncture doesn’t work, they will frequently advocate the use of “pragmatic” trials, lower quality trials of “real world effectiveness” that do not adequately control for placebo effects. It’s putting the cart before the horse.
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Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation

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