I thank everyone for my warm welcome to the SBM community. Although vaccine myth is of particular interest to me, I promise that my posts wont all be vaccine related. There is, unfortunately, much to discuss. In fact I had a difficult time deciding which vaccine-related issue to write about for my inaugural post. In the end I came up with more of an opinion piece, but it’s an issue worth airing. Things in anti-vaccine land may be reaching a dangerous turning point.
Archive for Science and Medicine
It is not uncommon for Science Based Medicine to receive complaints about the tone of our writing. Some people feel that it is indelicate to use the “q” word (for the uninitiated, “q” is for “quack”) when describing practitioners who promote disproven therapies with jubilant fervor. Others believe it unkind to lump “well meaning” alternative medicine experts in with those who are engaged in overtly illegal activities.
We are all affected by the tension between wanting to call a spade a spade and respecting our cultural need to be polite. Perhaps one of the clearest examples of this inner conflict is Orac’s Respectful Insolence blog. As the name implies, Orac is both thoughtful and brutally honest – he expresses our communal reticence to make waves, but follows up with a reasoned hostility that is quite understandable, given the circumstances described in each post. Respectful Insolence is fun to read because it is educational, persuasive, and expressive – and it captures how many of us feel about various forms of hucksterism. However, snake oil salesmen and their sympathizers are unlikely to enjoy the blog.
Here at Science Based Medicine, readers find a wide range of expression with a common commitment to science and reason. Just as physicians have different practice styles (some are more nurturing in temperament, others offer “tough love”) so too do we authors vary in tone. For those readers who favor one style over another – I hope you’ll find the voice that suits you and return regularly for more. Please don’t assume that one particular post is representative of the entire blog, and please don’t be offended by the legitimate exasperation of writers who have suffered through decades of observing swindlers swindle.
Of all the posts I and my cobloggers have written for SBM over the last 15 months, most provoke relatively few comments. However, a few stand out for having provoked hundreds of comments. The very first post that provoked hundreds of comments was Harriet’s excellent discussion of the International Network of Cholesterol Skeptics. In fact, Harriet seems to be quite good at writing posts that provoke a lot of comment, as another of her posts, specifically the one in which she discussed circumcision, also garnered hundreds of comments. However, to my great surprise, the one post that stands out as having received the most comments thus far in the history of SBM is one that I wrote. Specifically, it was a post I called Death by “alternative” medicine: Who’s to blame?, which has collected an astonishing 611 comments thus far. The topic of the post was a case report that I had heard while visiting the tumor board of an affiliate of my former cancer center describing a young woman who had rejected conventional therapy for an eminently treatable breast cancer and then returned two or three years later with a large, nasty tumor that was much more difficult to treat and possibly metastatic to the bone, which would make it no longer even potentially curable. My discussion centered on what the obligation of a physician is to such patients who utterly refuse the science- and evidence-based medicine that we know to be able to cure them of a potentially fatal disease, and I was not only surprised but somewhat taken aback by the vehemence of the discussion.
Since that post, I’ve always been meaning to take a look at what, exactly, the effect of choosing “alternative” medicine over “conventional” medicine is on the odds of survival for breast cancer patients. Even though intuitively one would hypothesize that refusing scientific medicine and relying on placebo medicine instead would have a detrimental effect on survival, it turns out that this question is not as easy to answer as you might think. For example, if you do a search on PubMed using terms like “alternative medicine,” “breast cancer,” and “survival,” the vast majority of the hits will be studies of complementary and alternative medicine (CAM) and breast cancer with little reference to what possible effect these therapies might have on survival. I can envision several reasons for this, the first being that–thankfully–relatively few women actually use alternative medicine exclusively to treat their breast cancer. Also, those that do probably drop off the radar screen of their science-based practitioners, and it is difficult, if not impossible, to capture data regarding their outcomes, given that they all too often stick with their alternative healers until the end. True, they may pop up again in their surgeon’s or primary care doctor’s office with huge, fungating tumors, only to be told that they have to undergo chemotherapy to shrink the tumor before any surgery is possible, after which they will often disappear again. Another important reason is that the natural history of breast cancer is extremely variable, from nasty, aggressive tumors that kill within months to indolent, slow-growing tumors that, even when metastatic, women can survive with for several years. (It is, of course, these women who usually show up in “alternative medicine” testimonials, because they can survive a long time with little or no treatment before their tumors progress.)
The latest event sponsored by “integrative medicine” proponents on my medical school campus featured the naturopath “Dr.” PB, a 2003 graduate and valedictorian from Bastyr University. Advertisements all over campus billed the lecture as “Stress, nutrition, and the GI tract,” which seemed innocuous enough. However, the lecture title as written on PB’s slide show was “Naturopathic apologetics for treating the gut.” He explained “treating the gut” to mean that for a wide variety of symptoms the naturopath’s diagnosis inevitibly focuses on the intestine and interventions nearly always involve dietary changes or supplements. Apparently some critics find this preoccupation to be excessive; hence “apologetics,” a word that connotes rational defense of articles of faith. This word choice was appropriate, as the lecturer wove snippets of basic physiology, but never any direct evidence, into a just-so story about how nearly all disease is caused by the modern lifestyle and can be ameliorate with dietary intervention.
Is it ethical to overstate the efficacy of a treatment option, if it might lead to a patient’s enhanced experience of that treatment? Your response to this question may reveal the degree to which you favor Complementary and Alternative Medicine (CAM). Let me explain.
As far as I can tell, no CAM treatment has been proven effective beyond placebo. (If you’re not convinced of this, I suggest you take a look at Barker Bausell’s book on the subject.) That means that treatments like acupuncture, homeopathy, Reiki, energy healing, Traditional Chinese Medicine (such as cupping), and others (like “liver flushes”) perform about as well as placebos (inert alternatives) in head-to-head studies. Therefore, the effects of these treatments cannot be explained by inherent mechanisms of action, but rather the mind’s perception of their value. In essence, the majority of CAM treatments are likely to be placebo therapies, with different levels of associated ritual.
For the sake of argument, let’s assume that CAM therapies are in fact placebos – the question then becomes, is it ethical to prescribe placebos to patients? It seems that many U.S. physicians believe that it is not appropriate to overstate potential therapeutic benefits to patients. In fact, the AMA strictly prohibits such a practice:
“Physicians may use [a] placebo for diagnosis or treatment only if the patient is informed of and agrees to its use.”
Moreover, a recent article in the New England Journal of Medicine concludes:
“Outside the setting of clinical trials, there is no justification for the use of placebos.”
However, there is some wavering on the absolute contraindication of placebos. A recent survey conducted by researchers at the Mayo Clinic asked physicians if it was permissible to give a dextrose tablet to a non-diabetic patient with fibromyalgia if that tablet was shown to be superior to no treatment in a clinical trial. In this case 62% of respondents said that it would be acceptable to give the pill.
The authors note:
“Before 1960, administration of inert substances to promote placebo effects or to satisfy patients’ expectations of receiving a prescribed treatment was commonplace in medical practice. With the development of effective pharmaceutical interventions and the increased emphasis on informed consent, the use of placebo treatments in clinical care has been widely criticized. Prescribing a placebo, it is claimed, involves deception and therefore violates patients’ autonomy and informed consent. Advocates of placebo treatments argue that promoting the placebo effect might be one of the most effective treatments available for many chronic conditions and can be accomplished without deception.”
How do you feel about placebos? Are they a legitimate option in some cases, or a violation of patient autonomy and informed consent?
The primary goal of science-based medicine (SBM) is to connect the practice of medicine to the best currently available science. This is similar to evidence-based medicine (EBM), although we quibble about the relative roles of evidence vs prior plausibility. In a recent survey 86% of Americans said they thought that science education was “absolutely essential” or “very important” to the healthcare system. So there seems to be general agreement that science is a good way to determine which treatments are safe and work and which ones are not safe or don’t work.
The need for SBM also stems from an understanding of human frailty – there are a host of psychological effects and intellectual pitfalls that tend to lead us to wrong conclusions. Even the smartest and best-meaning among us can be lead astray by the failure to recognize a subtle error in logic or perception. In fact, coming to a reliable conclusion is hard work, and is always a work in progress.
There are also huge pressures at work that value things other than just the most effective healthcare. Industry, for example, is often motivated by profit. Institutions and health care providers may be motivated by the desire for prestige in addition to profits. Insurance companies are motivated by cost savings. Everyone is motivated by a desire to have the best health possible – we all want treatments that work safely, often more so than the desire to be logical or consistent. And often personal or institutional ideology comes into play – we want health care to validate our belief systems.
Thankfully, I don’t receive all that much blog-related mail. But this weekend I received several communications about a piece in popular liberal blog. The piece is (ostensibly) about Lyme disease, which coincidentally happens to be one of the topics of my first post here at SBM. In fact, I’ve written about Lyme disease a number of times, and Dr. Novella has a very good summary of the controversy at one of his other blogs. Since we’ve discussed this so many times, I won’t be reviewing the entire controversy, but looking at this particular blog post to examine how our personal experiences and errors in reasoning can distort our view of reality.
The topic of Lyme disease has come up recently in the press, and as the weather improves, cases in the northeastern U.S. should start to increase soon. Just as a reminder, so-called “chronic” Lyme disease is not Lyme disease at all. Lyme disease can have early and late manifestations, none of which correspond to the vague, protean symptoms labeled as “chronic” by some. The disease is often diagnosed without resort to objective evidence, such as reliable, positive lab tests. But let’s look at the blog post in question and see what’s there.
The overriding them, the raison d’être if you will, of this blog is science-based medicine. However, it goes beyond that in that we here at SBM believe that science- and evidence-based medicine is the best medicine. It’s more than the best medicine, though; it’s the best strategy for medicine to improve therapy for our patients. We frequently contrast science-based medicine with various forms of “complementary and alternative medicine,” specifically pointing out that SBM changes its practices as new science and new evidence mandates it while CAM tends to rely on ancient, vitalistic, pre-scientific or pre-modern scientific beliefs about how disease occurs as the basis for its therapies. Although it may be painfully slow and frustrating at times and even though there may be major stumbles along the way, the overall course of SBM over the last century has in general been to produce ever more effective therapies and to discard therapies that are either ineffective or whose risk-benefit ratios are insufficiently favorable. The one single most important thing behind the advancement of medicine is good science.
That’s why I really, really hate scientific fraud, and I’m really, really upset, perhaps even more so than Dr. Atwood, over the discovery last week of what is arguably one of the most massive scientific frauds in medical history. It doesn’t matter that Dr. Atwood is an anaesthesiologist and I am not, meaning that the specific scientific fraud unearthed, which was perpetrated by an anesthesiologist studying multimodal anesthesia, as reported in Anesthesiology News, the Wall Street Journal, and the New York Times. I am a surgeon, and the relief of surgical pain in my patients is an important part of my practice. If the scientific basis of what my colleagues in anesthesiology do before, during, and after my operations is called into doubt, I have to wonder if I am giving my patients the best surgical care. Aside from that, there is the intellectual outrage I feel as a result of seeing science and patients betrayed in such a systematic and blatant manner.
Last week the story broke that Scott Reuben, an anesthesiologist and clinical researcher at Baystate Medical Center in Springfield, MA, had falsified data in at least 21 publications over a period of at least 12 years—making it one of the most enduring examples of scientific fraud in memory. Almost all of Reuben’s papers had reported innovative methods for providing post-operative pain relief (analgesia); many of them involved ‘multimodal’ regimens for painful orthopedic procedures such as spinal fusions and total knee replacements. Recent papers reported regimens that included celecoxib (Celebrex) and pregabalin (Lyrica), both made by Pfizer. Much of Reuben’s research had been funded by Pfizer, and Reuben has been a member of the Pfizer speaker’s bureau (that information is included because the reader would otherwise wonder, but there is no indication that Pfizer has been intentionally involved in Reuben’s fraud).
I will not discuss this case in detail; look for a more comprehensive piece on SBM next week. Rather, I present it now to offer a local example of how such a breach of trust affects those who rely on clinical research to inform their care of patients.
One of the consistent themes of SBM since its very inception has been that, when it comes to determining the efficacy (or lack thereof) of any particular medicince, therapy, or interventions, anecdotes are inherently unreliable. Steve Novella explained why quite well early in the history of this blog, and I myself described why otherwise intelligent people can be so prone to being misled by personal experience and anecdotal evidence. Unfortunately, as I have also demonstrated, it’s not just patients who can allow themselves to be misled by anecdotes, but certain physicians who do not understand the scientific method but in their hubris think that their “personal clinical experience” trumps science, clinical trials, and epidemiology.
None of this is to say that there aren’t frequent instances when applying data from population-based studies to individual patients is problematic. It can indeed be. However, it often goes beyond that, and, indeed, if there is one defining characteristic of a quack that I’ve never failed to find when looking at individual cases, it’s a belief that he is able to identify when a treatment works based on his own personal experience and anecdotes. Unfortunately, it’s not just quacks who sometimes fall prey to this, because humans are cognitively wired to infer causation from correlation. This tendency, which was no doubt adaptive early in our evolution, simply doesn’t work well when it is applied to medicine and science. Without a doubt, it is the key driver, for example, behind the widely believed myth that vaccines somehow cause autism and that chelation therapy and other biomedical quackery can “cure” autism, a view popularized most recently by the very popular but very ignorant Jenny McCarthy in the U.S. and before that by the outright dishonest Andrew Wakefield in the U.K.
One of the other reasons why testimonials for quackery seem convincing is because most people simply do not know enough about disease, be it my specialty (cancer) or any other disease, how it is treated, and what its natural course can be expected to be. That is why, when I came across an example of just such a testimonial, specifically a breast cancer testimonial, I saw what is known as a “teachable moment. This teachable moment occurred on the very popular science blog Pharyngula, written by the ever sarcastic biology professor from Minnesota, P.Z. Myers. It actually surprised me in that the usual topics on Pharyngula include evolution, biology, the pseudoscience known as “intelligent design” creationism, politics, and atheism. P.Z. doesn’t usually dabble much in the realm of medical quackery, but my guess is that he was attracted to this particular piece of pseudoscience because of the religious angle.
Specifically, the quackery under consideration is known as God’s Answer to Cancer (GAC). Basically, it looks a lot like any number of quack electronic devices that promise to cure cancer; examples include Bill Nelson’s Electro Physiological Feedback Xrroid (EPFX) machine (1, 2, 3), Hulda Clark’s parasite zapper, or Alan Back’s Advanced Bio-photon Analyzer. All of these devices promise, in essence, to use low level electrical energy to “boost the immune system” and “replenish your life energy” plus or minus an additional promise to “zap parasites” (Hulda Clark’s unique spin on these devices, in which she claims that all cancer, AIDS, and most other diseases are due to a liver fluke, which her device supposedly “zaps.” Like these devices, the maker of GAC promises vague “immune system boosts,” but with the added twist that he claims that all disease is due to original sin (along, apparently, with the conventional alt-med “toxins,” diminished qi, and uncharacterized immune dysfunction). Amusingly, the Monsignor who created this device also disses Hulda Clark and advocates the use of laetrile and Linus Pauling’s orthomolecular medicine. The main difference is that he claims to have received the design for the device from God through a dream.