Science-Based Medicine

It never seems to fail. I go away for a few days, in this case to combine fun with pleasure and pleasure with fun by giving a talk to the Chicago Skeptics and at the same time meeting my brand new (well, by this time three weeks old) nephew for the first time, and something always happens. Before I get to what happened, I just want to point out that the talk actually went pretty darned well. I was utterly shocked that it was pretty much standing room only, with perhaps 50 people there to hear me. Honestly, don’t you people have anything better to do on a beautiful Saturday afternoon in August? But, seriously, the whole thing was a blast, and the assembled skeptics there didn’t even let me off the hook, as at least a couple of them asked some fairly challenging questions, one of which, I must admit, I wasn’t prepared for. In any case, my thanks go out to Dr. Jennifer Newport, skeptical Chicago pediatrician extraordinaire and organizer of my talk and the party at her apartment afterward. Between the two events she raised hundreds of dollars for the vaccination drive going on at DragonCon this weekend, Chicago Skeptics, the Women Thinking Free Foundation, and CFI-Chicago for inviting me and being such fantastic hosts.

Back to business. Science-based medicine (SBM) business, that is.

What happened while I was away could almost be characterized by the New England Journal of Medicine (NEJM) singing “Oops, I did it again.” Three weeks ago, the hallowed pages of the NEJM hosted a truly execrably credulous review article about acupuncture. So bad was the article that it “merited” the incredibly rare triple beat-down from this very blog, with posts by Steve Novella, the ever-irascible Mark Crislip, and myself in rapid succession applying the clue-by-four. As I was preparing to leave for Chicago on Thursday, I happened to look at the very latest issue of the NEJM hot off the presses, and what to my wondering (and watering–it is ragweed season) eyes should appear but an article reporting a study on the use of tai chi in treating fibromyalgia. Entitled A Randomized Trial of Tai Chi for Fibromyalgia, the study comes out of the Tufts University School of Medicine and the Newton-Wellesley Hospital in Boston and was carried out by a team led by Chenchen Wang, MD, MPH. Not surprisingly, the study has gotten a lot of play in the media, for example, in this story in the L.A. Times, which is at least reasonably restrained, probably because it an AP wire story by Marilynn Marchione, who has written some excellent articles about “alternative” medicine before. Even the usually reliable GoozNews seems smitten with this study beyond what it rates, characterizing it as “rare victory for the National Institute of Health’s National Center for Complementary and Alternative Medicine and Sen. Tom Harkin (D-IA), who routinely comes under fire for pushing funding for these types of studies.”

I’m less impressed. You’ll see what I mean in a few minutes, I hope. First, however, let’s look at the study itself.
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One of the main topics that we’ve covered here on this blog over the last couple of years is the relatively rapid, seemingly relentless infiltration of pseudoscience into what should be bastions of science-based medicine (SBM), namely medical schools and academic medical centers promoted by academics who should, but apparently don’t, know better. From the very beginning, we’ve written numerous posts about this infiltration and how it has been facilitated by a variety of factors, including changes in the culture of medical academia and our own culture in general, not to mention a dedicated cadre of ideologues such as the Bravewell Collaboration, whose purpose is to blur the lines between science and pseudoscience and promote the “integration” of quackery into science-based medicine. Certainly promoters of what Dr. Robert W. Donnell termed “quackademic medicine” wouldn’t put it that way, but I would. Indeed, promoters of quackademic medicine scored a major victory last month, when a credulous piece of tripe about acupuncture passing as a review article managed to find its way into the New England Journal Medicine, a misstep that was promptly skewered by Mark Crislip, Steve Novella, and myself. It’s rare for more than two of us to write about the same topic, but it was earned by a mistake as dire as the editors of the NEJM allowing rank pseudoscience to sully its normally science-based pages.

Today, I want to riff a bit on one aspect of this phenomenon. As a cancer surgeon, I’ve dedicated myself to treating patients with cancer and then subspecialized even further, dedicating myself to the surgical treatment of breast cancer. Consequently, the interface of so-called “complementary and alternative medicine” (CAM) in the treatment of cancer both interests and appalls me. The reason for my horror at the application of CAM to cancer patients, as you might expect, is that cancer is a disease that is highly feared and can be highly deadly, depending upon the specific kind of cancer. Cancer patients deserve nothing less than the best science-based evidence that we have to offer, free of pseudoscience. Yet in even the most highly respected cancer centers, such as M.D. Anderson Cancer Center and Memorial Sloan-Kettering Cancer Center, there are departments or divisions of what is increasingly called “integrative oncology.” The claim behind “integrative oncology” is that it is “integrating the best of science-based and ‘alternative’ medicine,” but in reality all too often it is “integrating” quackery with science-based medicine. I have yet to hear an explanation of how “integrating” pseudoscience or nonscience into science-based oncology benefits cancer patients, but, then, that’s probably just the nasty old reductionist in me. Let’s find out.
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The longer I’m in this whole science-based medicine thing, not to mention the whole skepticism thing, the more I realize that no form of science is immune to woo. To move away from medicine just for a moment, even though I lament just how many people do not accept evolution, for example, I can somewhat understand it. Although the basics of the science and evidence support the theory of evolution as the central organizing principle of all biology, much of the evidence is not readily apparent to those who don’t make it a calling to study biology, evolution, and speciation. It’s not like, for example, gravity, which everyone experiences and of which everyone has a “gut level” understanding. So, not unexpectedly, when the theory of evolution conflicts with a person’s religious beliefs, for most people it’s very easy to discount the massive quantities of evidence that undergird the theory of evolution. It’s not so easy to discount the evidence for gravity.

In many ways, medicine is similar to evolution, but the situation is possibly even worse. The reason is that much of the evidence in medicine is conflicting and not readily apparent to the average person. There’s more than that, though, in that there are a number of confounding factors that make it very easy to come to the wrong conclusion in medicine, particularly when looking at single cases. Placebo effects and regression to the mean, for example, can make it appear to individual patients that, for example, water (i.e., what the quackery that is homeopathy is) or placebo interventions (i.e., acupuncture) cures or improves various medical conditions. Add to that confirmation bias, the normal human cognitive quirk whereby all of us — and I do mean all of us — tend to remember information that reinforces our preexisting beliefs and to forget information that would tend to refute those beliefs — and, at the level of a single person or even practitioner, it’s very, very easy to be misled in medicine into thinking that quackery works. On the other hand, at the single patient/practitioner level, one can also see evidence of the efficacy of modern medicine; for example, when a person catches pneumonia, is treated with antibiotics, and recovers quickly. Regardless of whether they’re being used to demonstrate quackery or scientific medicine, because personal experience and the evidence that people observe at the level of the people they know can be very deceptive in medicine, science-based medicine, with its basic science underpinnings and clinical trial evidence, is necessary to try to tease out what actually works and what doesn’t.

Medicine does, however, have its version of a theory of evolution, at least in terms of how well-supported and integrated into the very fabric of medicine it is. That theory is the germ theory of disease, which, just as evolution is the organizing principle of biology, functions as the organizing principle of infectious disease in medicine. When I first became interested in skepticism and medical pseudoscience and quackery, I couldn’t envision how anyone could deny the germ theory of disease. It just didn’t compute to me, given how copious the evidence in favor of this particular theory is. It turns out that I was wrong about that, too.

On Friday there was a video released that provides a very clear, succinct explanation of germ theory denialism:

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One of the things that disturbs me the most about where medicine is going is the infiltration of quackery into academic medicine. So prevalent is this unfortunate phenomenon that Doctor RW even coined a truly apt term for it: Quackademic medicine. In essence, pseudoscientific and even prescientific ideas are rapidly being “integrated” with science-based medicine, or, as I tend to view it, quackery is being “integrated” with scientific medicine, to the gradual erosion of scientific standards in medicine. No quackery is too quacky, it seems. Even homeopathy and naturopathy can seemingly find their way into academic medical centers.

Probably the most common form of pseudoscience to wend its way into what should be bastions of scientific medicine is acupuncture. Harvard, Stanford, Yale, M. D. Anderson, and many others, they’ve all fallen under the sway of the idea that somehow sticking thin little needles into points that bear no relationship to any known anatomic structure and that supposedly “unblock” the flow of some sort of “life energy” that can’t be detected by any means that science has. Most recently, as I described, studies that seek to “prove that acupuncture works” have found their way into high quality, high impact journals whose editors should know better but apparently can’t recognize that the evidence in the study doesn’t actually show what the authors claim it shows. Even so, there are some journals that I didn’t expect to see this sort of infiltration of quackademic medicine. Granted, I never expected it to show itself in one of the Nature journals, as it did in the study I just mentioned. I also never expected it to show up in that flagship of clinical journals, a journal that is one of the highest impact and most read medical journals that exists. I’m talking the New England Journal of Medicine, and, unfortunately, I’m also talking an unfortunately credulous article from Dr. Brian M. Berman, who is the founder of the Center for Integrative Medicine, University of Maryland School of Medicine and the holder of multiple NCCAM center grants, and other institutions, entitled Acupuncture for Chronic Low Back Pain.
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One of the recurring themes of this blog, not surprisingly given its name, is the proper role of science in medicine. As Dr. Novella has made clear from the very beginning, we advocate science-based medicine (SBM), which is what evidence-based medicine (EBM) should be. SBM tries to overcome the shortcomings of EBM by taking into account all the evidence, both scientific and clinical, in deciding what therapies work, what therapies don’t work, and why. To recap, a major part of our thesis is that EBM, although a step forward over prior dogma-based medical models, ultimately falls short of making medicine as effective as it can be. As currently practiced, EBM appears to worship clinical trial evidence above all else and nearly completely ignores basic science considerations, relegating them to the lowest form of evidence, lower than even small case series. This blind spot has directly contributed to the infiltration of quackery into academic medicine and so-called EBM because in the cases of ridiculously improbable modalities like homeopathy and reiki, deficiencies in how clinical trials are conducted and analyzed can make it appear that these modalities might actually have efficacy.

Given this thesis, if there’s one aspect of medical education that I consider to be paramount, at least when it comes to understanding how to analyze and apply all the evidence, both basic science and clinical, it’s a firm grounding in the scientific method. Unfortunately, in medical school there is very little, if any, concentration on the scientific method. In fact, one thing that shocked me when I first entered what is one of the best medical schools in the U.S., the University of Michigan, was just how “practical” the science taught to us as students was. It was very much a “just the facts, ma’am,” sort of presentation, with little, if any, emphasis on how those scientific facts were discovered. Indeed, before I entered medical school, I had taken graduate level biochemistry courses for a whole year. This was some truly hard core stuff. Unfortunately, I couldn’t get out of taking medical school biochemistry my first year, but taking the course was illuminating. The contrast was marked in that in medical school there was very little in the way of mechanistic detail, but there was a whole lot of memorization. The same was true in nearly all the other classes we took in the first two years. True, for anatomy it’s pretty hard not to have to engage in a lot of rote memorization, but the same shouldn’t necessarily be true of physiology and pharmacology, for example. It was, though.

Over time, I came to realize that there was no easy answer to correcting this problem, because medical school is far more akin to a trade school than a science training school, and the question of how much science and in what form it should be taught are difficult questions that go to the heart of medical education and what it means to be a good physician. Clearly, I believe that, among other things, a good physician must use science-based practice, but how does medical education achieve that? That’s one reason why I’m both appalled and intrigued by a program at the Mt. Sinai School of Medicine for humanities majors to enter medical school without all the hard sciences. It’s a program that was written up in the New York Times last Wednesday in an article entitled Getting Into Med School Without Hard Sciences, and whose results were published in Medical Academia under the title Challenging Traditional Premedical Requirements as Predictors of Success in Medical School: The Mount Sinai School of Medicine Humanities and Medicine Program.

Let’s first take a look at how the NYT described the program:
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On Friday, one of my partners in crime here at Science-Based Medicine, Dr. Kimball Atwood, wrote an excellent Open Letter to Dr. Josephine Briggs. Dr. Briggs, as most regular readers of SBM know, is the Director of the National Center for Complementary and Alternative Medicine (NCCAM). As most regular readers of SBM also know, we at SBM have been quite critical of NCCAM for its funding of studies of dubious scientific value, including one that I mentioned quite early on in the history of this blog, in which an R21 grant was awarded to investigators at the University of Arizona for a project entitled Dilution and succussion in homeopathic remedy dose-response patterns. The purpose of this project was to compare the effectiveness of a homeopathic remedy at different dilutions. It even compared remedies that are succussed (vigorously shaken) at each dilution step against remedies that were merely stirred. Although this is merely the most egregious example I could find at the time, two years ago I did catalog many more examples, as well as the “educational” grants disbursed through NCCAM in order to teach (and, by doing so, promote) CAM.

Given NCCAM’s long history of promoting pseudoscience, we were all quite surprised when early this year we received an e-mail from Dr. Briggs herself inviting us to NCCAM to meet with her. Unfortunately, due to our work obligations, Steve Novella, Kimball Atwood, and I were not able to coordinate our schedules to travel to Bethesda and enter the heart of darkness itself until early April. Our conversation with Dr. Briggs and her staff was cordial and mutually respectful, as Steve Novella described, and we assured her that we understood that studies such as the one I mentioned above were funded before her tenure. At the same time we were a bit disappointed that Dr. Briggs appeared far too eager to dismiss such problems as being before her time. Still, we understood and approved of Dr. Briggs’ stated goal of making NCCAM more scientifically rigorous, even though we did point out that there is nothing done at NCCAM that couldn’t be done as well in the NIH’s structure before NCCAM existed.

Unfortunately, not too long before or after Dr. Briggs met with us, she also met with a group of homeopaths, leading us to worry that perhaps in her quest to appear “open-minded,” Dr. Briggs was being so open-minded that her brain was in acute danger of falling out, particularly after we saw her infamous “science must be neutral” director’s newsletter a month later, which Dr. Kimball skewered as part of his open letter and I recently used as an example of misinterpreting what scientific “neutrality” means during my talk at the SBM Workshop at TAM8 a couple of weeks ago. In fact, I now wonder if I missed a little gray matter oozing out of Dr. Briggs’ ears during the meeting even though I sat right next to her.

Unfortunately, Dr. Atwood’s open letter gives me even more reason to despair, because in it he pointed out that Dr. Briggs will be speaking at the 25th Anniversary Convention of the American Association of Naturopathic Physicians (AANP) from August 11-15 in Portland, OR. (One wonders if Mark Crislip would be willing to make an appearance there for a Very Special Episode of his Quackcast and thereby continue to expand his Internet empire. I realize that doing so would really be “taking one for the team,” but think of the blogging and podcast material!) Kimball’s explanation why this is disturbing is excellent and detailed, as usual, but one thing he didn’t do as much of as I would have is to go into a bit more detail of what sorts of dubious medical modalities and even outright quackery Dr. Briggs will be associating herself with by speaking at this particular convention. He probably didn’t feel the need, given that he referenced his two comprehensive deconstructions of the quackery that is naturopathy, but I’m not as well-versed in naturopathy as he is, and, I suspect, neither are you. Dr. Atwood didn’t need to delve into the woo that will be presented at the AANP. I do. That’s why I thought a bit of a survey of what will be presented at the conference was in order.
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Josephine P. Briggs, M.D.

Director, National Center for Complementary and Alternative Medicine

Dear Dr. Briggs,

As you know, we’ve met twice. The first time was at the Yale “Integrative Medicine” Symposium in March. The second was in April, when Drs. Novella, Gorski and I met with you for an hour at the NCCAM in Bethesda. At the time I concluded that you favor science-based medicine, although you are in the awkward position of having to appear ‘open-minded’ about nonsense.

More about that below, but first let me address the principal reason for this letter: it is disturbing that you will shortly appear at the 25th Anniversary Convention of the American Association of Naturopathic Physicians (AANP). It is disturbing for two reasons: first, it suggests that you know little about the tenets and methods of the group that you’ll be addressing; second, your presence will be interpreted as an endorsement of those methods and of that group—whether or not that is your intention. If you read nothing more of this letter or its links, please read the following articles (they’re “part of your education,” as my 91 y.o. mother used to say to me):

Naturopathy: A Critical Appraisal

Naturopathy, Pseudoscience, and Medicine: Myths and Fallacies vs Truth

The first article is an introduction to the group to which you will be speaking; the second is my response to complaints, from that group and a few of its apologists, about the first article. It was a surprise to me that the editor, George Lundberg, preferred that I make my response a comprehensive one.

Thus the second article inevitably became the crash course—call it CAM for Smarties—that your predecessors never offered you, replete with examples of useless and dangerous pseudoscientific methods, real science being brought to bear in evaluating such methods, proponents’ inaccurate or cherry-picked citations of biomedical literature, bits of pertinent but little-known history, the standard logical fallacies, embarrassing socio-political machinations, wasteful and dangerous ‘research’ (funded—unwittingly, I’m sure—by the NCCAM), bait-and-switch labeling of rational methods as “CAM,” vacuous assertions about ‘toxins’ and ”curing the underlying cause, not just suppressing the symptoms,” anti-vaccination hysteria, misleading language, the obligatory recycling of psychokinesis claims, and more.

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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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A few weeks ago I posted an article about bogus diagnostic tests. I cited Doctor’s Data, Inc. (DDI), as “a company with a long history of dubious offerings.” I also wrote:

You can’t help but have noticed that many of the links in this post are to articles on Quackwatch. That’s because the site is chock full of useful information about bogus tests, far more than can be found elsewhere. There you will find a more comprehensive list of bogus tests than I’ve mentioned here, and a larger list of laboratories peddling them. You’ll also find an article on “Dubious Genetic Testing” co-authored by the Quackwatch founder, Stephen Barrett, and our own Harriet Hall, and an article about bogus “biomedical treatments” for autism showing that—surprise!—Doctor’s Data and Genova Diagnostics are major players there, too.

I stand by all of those statements. It turns out that Doctor’s Data is not pleased that Dr. Barrett has so thoroughly blown the company’s cover.

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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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