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Revisiting Daniel Moerman and “placebo effects”

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

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

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Answering another criticism of science-based medicine

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

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

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Consumer Reports drops the ball on alternative medicine

Ever since I was a teenager, I’ve intermittently read Consumer Reports, relying on it for guidance in all manner of purchase decisions. CR has been known for rigorous testing of all manner of consumer products and the rating of various services, arriving at its rankings through a systematic testing method that, while not necessarily bulletproof, has been far more organized and consistent than most other ranking systems. True, I haven’t always agreed with CR’s rankings of products and services about which I know a lot, but at the very least CR has often made me think about how much of my assessments are based on objective measures and how much on subjective measures.

Until now.

I just saw something yesterday on the CR website that has made me wonder just how scientific CR’s testing methods are, as CR has apparently decided to promote alternative medicine modalities by “assessing” them in an utterly scientifically ignorant manner. Maybe I just haven’t been following CR regularly for a while, but if there’s an article that demonstrates exactly why consumer product testing organizations should not be testing medical treatments; they are ill-equipped to do so and lack the expertise and knowledge. The first red flag was the title, namely Hands-on, mind-body therapies beat supplements. The second red flag was the introduction to the article:

A new survey of subscribers to Consumer Reports found that prescription drugs generally performed better than alternative therapies for 12 common health problems. But hands-on treatments such as chiropractic care and deep-tissue massage, as well as mind-body therapies such as yoga and meditation, held their own, especially for certain conditions. Far fewer said that dietary supplements helped a lot.

Prescription drugs helped the most for nine of the conditions we asked about: allergies, anxiety, colds and flu, depression, digestive problems, headache and migraine, insomnia, irritable bowel syndrome, and osteoarthritis.

But chiropractic care performed better than drugs for back pain, and deep-tissue massage beat drugs for neck pain. Massage was as also as good as drugs for fibromyalgia. Those hands-on therapies also scored near the top for osteoarthritis as well as for headaches and migraines.

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Posted in: Science and the Media

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On the Orwellian language and bad science of the anti-vaccine movement: “SmartVax” versus “MaxVax”?

If there’s one thing that’s true of the human race, it’s that when it comes to persuasion language is has power. Words have power. Just ask the advertising industry or politicians, who rely on their skills manipulating language to persuade for their very livelihood and authority. In the specific bailiwick of this blog, Science-Based Medicine, many of us have spent considerable verbiage describing how advocates of unscientific modalities rebranded as “complementary and alternative medicine” (CAM) and/or “integrative medicine” (IM) are incredibly skilled at the manipulation of language and renaming of terms in order to make them sound more persuasive, particularly to make it sound as though their modalities are scientifically supported or that it’s just another “alternative” to SBM. In fact, Kimball Atwood has made a special study of the language of CAM, even going so far to do an amusing feature that he used to call the Weekly Waluation of the Weasel Words of Woo. Indeed, the very name “integrative medicine” is a masterful term that makes it sound as though they’re just “integrating” the best of scientific medicine and “traditional” or “alternative” medicine when in fact what is happening all too often is the “integration” of quackery with medicine or, as I sometimes like to call it, “integrating” fake medicine with real medicine. Unfortunately, my definition of “integrative medicine” doesn’t appear to be winning, although I was gratified that I got several Tweets during our panel at TAM9 quoting my line about integrating quackery with medicine.

The anti-vaccine movement has been pretty good, albeit not as masterful as, say, Andrew Weil, when it comes to manipulating language to its own end. Who can forget three years ago, when the meme started spreading throughout the anti-vaccine movement that it’s “not anti-vaccine but rather ‘pro-safe vaccine'” and started demanding that the government and pharmaceutical companies “green our vaccines.” The reason is obvious; even anti-vaccine activists know that it’s a public relations loser to be explicitly anti-vaccine, which is Jenny McCarthy and the anti-vaccine groups that participated in her “Green Our Vaccines” rally did their best to downplay and hide their radical anti-vaccine base. They failed. (The signs about vaccines as “weapons of mass destruction” rather undercut the “pro-safe vaccine” message. I’ve dealt with this fallacy before in depth, explaining why it is appropriate to call them “anti-vaccine,” even as they strenuously deny that they are. More recently, the preferred narrative has been “too many, too soon,” which leads me to another term coined by the group SafeMinds and promoted on—where else?—Age of Autism.

Now, the SafeMinds/AoA approach is being dubbed “SmartVax.”
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Posted in: Public Health, Science and the Media, Vaccines

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Spin City: Using placebos to evaluate objective and subjective responses in asthma

As I type this, I’m on an airplane flying home from The Amazing Meeting 9 in Las Vegas. Sadly, I couldn’t stay for Sunday; my day job calls as I’ll be hosting a visiting professor. However, I can say—and with considerable justification, I believe—that out little portion of TAM mirrored the bigger picture in that it was a big success. Attendance at both our workshop on Thursday and our panel discussion on placebos on Saturday was fantastic, beyond our most optimistic expectations. There was also a bit of truly amazing serendipity that helped make our panel discussion on placebo medicine an even bigger success.

If there’s one thing about going away to a meeting, be it TAM or a professional meeting, it’s that it suddenly becomes very difficult for me to keep track of all the medical and blog stuff that I normally keep track of and nearly impossible to keep up with the medical literature. This is the likely explanation for why I had been unaware of a study published in the New England Journal of Medicine (NEJM) on Thursday that was so relevant to our discussion and illustrated out points so perfectly that it was hard to believe that some divine force didn’t give it to us in order to make our panel a total success.

Just kidding. It was TAM, after all. It was, however, embarrassing that I didn’t see the study until the morning of our panel, when Kimball Atwood showed it to me.

Before I get to the meat of this study and why it fit into our nefarious plans for world domination, (or at least the domination of medicine by science-based treatments), a brief recap of the panel discussion would seem to be in order. First, for the most part, we all more or less agreed that the term “placebo effect” is a misnomer and somewhat deceptive because it implies that there is a true physiologic effect caused by an inert intervention. “Placebo response” or “placebo responses” seemed to us a better term because what we are observing with a placebo is in reality a patient’s subjective response to thinking that he is having something active done having something done. In general, we do not see placebo responses resulting improvement in objective outcomes; i.e., prolonged survival in cancer. The relative contributions of components of this response, be they expectancy effects (if you expect to feel better you likely will feel better), conditioning, or one that is frequently dismissed or downplayed, namely artifacts of the design of randomized clinical trials and even subtle (or even not-so-subtle) biases in trial design. This issue of placebo responses being observed only in subjective patient-reported clinical outcomes (pain, anxiety, and the like) and not in objectively measured outcomes is an important one, and it is one that goes to the heart of the NEJM study that so serendipitously manifested itself to us. As Mark Crislip so humorously pointed out, the placebo response is the beer goggles of medicine (this is not a spoiler or stealing Mark’s line; several TAM attendees have already tweeted Mark’s line), and much of what is being observed are changes in the patient’s perception of his symptoms rather than true changes in the underlying pathophysiology. This study drove the point home better than we could.

Another point discussed by the panel is also quite relevant. As more and more studies demonstrate very convincingly that “complementary and alternative medicine” (CAM) or “integrative medicine” (IM) therapies do not produce improvements in symptoms greater than placebo. Moreover, multiple studies, including a famous NEJM meta-analysis and a recently updated Cochrane review, demonstrate, placebo responses probably do not constitute meaningful responses. In light of these findings, CAM apologists, driven by ideology rather than science and masters of spin, have begun to admit grudgingly that, yes, in essence their treatments are elaborate placebos. Not to be deterred, instead of simply concluding that their CAM interventions do not work, they’ve moved the goal posts and started to try to argue that it doesn’t matter that CAM effects are placebo effects because placebos are “powerful” and good and—oh, yes, by the way—there are a lot of treatments in science-based medicine that do little better than placebos. In other words, CAM advocates elevate the subjective above the objective and sell the subjective, and that’s exactly what they are doing with this study.
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Posted in: Acupuncture, Clinical Trials, Medical Ethics

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Anti-vaccine propaganda in The Baltimore Sun

The hypothesis that vaccines cause autism has been about as thoroughly falsified through research as any health hypothesis can be. Even if, by bending over backward into a back-breaking contortionist pose to be “open-minded”, some people will concede that there’s still a bit of room for reasonable doubt about whether there is no link between vaccines and autism in “susceptible” populations, there is no room for reasonable doubt left over whether vaccines caused the so-called “autism-epidemic” of the last two decades. They did not. Similarly, the mercury-containing preservative thimerosal, which used to be in several childhood vaccines until the end of 2001, when thimerosal was removed from all but some flu vaccines, has been about as cleared of being a cause of autism as it is possible for a substance to be. Basically, if thimerosal-containing vaccines were a cause of autism, we would have expected to see a decrease in autism prevalence beginning three to five years after the removal of thimerosal. Epidemiological studies have failed to find such a decline and have also failed to find evidence of correlation. I realize that anti-vaccine activists argue that there are still trace amounts of thimerosal in some vaccines, but, even so, thimerosal exposure in children fell almost overnight to levels lower than the 1980s, which was before the beginning of the “autism epidemic.” At the very least, one would expect autism rates to fall back to 1980s levels if thimerosal in vaccines were a driving force behind this “epidemic.” They haven’t. Quite the contrary, they’ve continued to climb.

So why does the manufactroversy that vaccines cause autism persist? There is no longer a scientific controversy; by and large, the question has been asked and answered. Vaccines do not cause autism, as far as we can detect. True, it’s impossible to completely prove a negative hypothesis, but if there is any way that vaccines do cause autism, it’s at a level below the ability of large epidemiological studies with tens or even hundreds of thousands of children to detect. Yet the fear persists.

One reason is that it’s very hard to eradicate a false belief, once entrenched. I’ve discussed many times how difficult it is to change people’s minds, as motivated reasoning leads them to seek confirming evidence and discount all else. Disconfirming evidence can even lead people to harden their beliefs even more. In particular, the hardcore anti-vaccine activists who persist in spreading the vaccine-autism myth have an interest and motivation in this mythology at least as potent as the interest pharmaceutical companies have in defending vaccines—more so, arguably, given the emotional attachment people have for their children. After all, all pharmaceutical companies are interested in, according to this mythology, is profit. If a parent, correctly or incorrectly, somehow comes to believe that something or someone has hurt his or her child, it is among the most potent motivations known to do something about it.

Another reason is that the concept has become entrenched in our culture—or at least parts of our culture—to the point where it appears regularly in the media, thus reinforcing the idea among those who don’t pay attention to the issue or those who do but haven’t decided if they believe that vaccines cause autism that maybe there is something to fear. Maybe there is still a controversy. A perfect example appeared in The Baltimore Sun over the weekend entitled We don’t know enough about childhood vaccines and subtitled Researcher asks: Are 36 doses of vaccine by age 2 too much, too little, or just right? I contend that the editors of The Baltimore Sun, by publishing this anti-vaccine propaganda, which would have been at home on the websites of the anti-vaccine blog Age of Autism or on the website of anti-vaccine groups SafeMinds, Generation Rescue, the International Medical Council on Vaccination or the National Vaccine Information Center (NVIC). Examining this article, written by Margaret Dunkle, described as a “senior research scientist at the Department of Health Policy at George Washington University and director of the Early Identification and Intervention Collaborative for Los Angeles County” and as having “a family member who is vaccine-injured,” is what I would consider a “teachable moment” in analyzing the tactics of the anti-vaccine movement.
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Posted in: Public Health, Science and the Media, Vaccines

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An open letter to NIH Director Francis Collins regarding his appearance at the Society for Integrative Oncology

Note from the editor: Since today is a holiday in the U.S., I had planned on taking the day off. Then I saw the subject of today’s post and had to respond. Also, please remember that, as always, the usual disclaimers apply. This letter represents my opinion, and my opinion alone. It does not represent the view or opinion of my university or cancer center—or anyone else, for that matter, other than me.

Francis S. Collins, MD, PhD
Director, National Institutes of Health

Dear Dr. Collins:

I am normally not one for writing open letters, but in this case I feel compelled to make an exception. This letter will have little or nothing to do with what seems to be the usual criticism leveled against you, namely your intense religious faith and claims. Personally, as a physician and scientist I don’t much care about what religion you follow and, unlike some writers such as Sam Harris, most definitely do not consider your strong Christian faith a disqualification for holding the position that you now hold. All I care about in an NIH director is how well he or she shepherds the scientific mission of the NIH and runs the organization. As a past (and hopefully future) NIH grantee, I want the NIH to fund and support only the most rigorous science and to be a well-run organization. Thus far in your tenure, I haven’t seen any anything major to worry about on that score.

Recently, however, I was very disappointed to discover that you will be the keynote speaker at the 8th International Conference of the Society of Integrative Oncology (SIO) in November. I hope that, when you agreed to accept this speaking engagement, you didn’t know just what it is that what you were accepting or what the Society for Integrative Oncology is, other than a professional society that was interested in hearing your views on faith and spirituality in cancer. In brief, it is our position that “integrative oncology” is a discipline that, at its core, is dedicated to “integrating” pseudoscience with science. No doubt you will think I am exaggerating, but I am not, as I hope to demonstrate. Worse, by agreeing to speak to the SIO, you will be providing it with the imprimatur of your position as NIH director. The NIH, as you know, is the most respected biomedical research institution in the U.S., if not the world, and that respect rubs off wherever you speak.
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Posted in: Faith Healing & Spirituality, Politics and Regulation, Science and the Media

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Utah Senator Orrin Hatch: A pit bull in defense of the supplement industry

Editor’s note: This weekend was truly NIH grant crunch time. I have to get my final version of my R01 to our university’s grants office by Tuesday, or it might not get uploaded by the July 5 deadline. (Funny how electronic submission, which was supposed to make applicants’ lives easier, seems to have made them harder.) Consequently, I decided to take a few minutes and spiff up a post I did not long ago for my other blog and use it here, mainly because it is particularly relevant to our usual SBM topics. I’ll be back next time with something new.

The weakness and ineffectiveness of the law in the U.S. regulating dietary supplements has been a frequent topic here on Science-Based Medicine, including the continued failure of efforts to address the serious shortcomings of current law and the illogic at its very heart. Indeed, over the last decade or so that I’ve paid attention to relevant issues regarding supplements continually amazed at how much supplement manufacturers can get away with and for how long. For example, one of the most recent atrocities against science occurred when Boyd Haley, disgraced chemistry professor at the University of Kentucky and prominent member of the mercury militia wing of the anti-vaccine movement, tried to sell an industrial chelator as a dietary supplement to treat autistic children. True, that was too much even for the underfunded, undermanned FDA to ignore, but it was amazing how long he got away with it. Apparently it takes someone trying to market a chemical compound that can’t by any stretch of the imagination be characterized as a “nutrient” or “food” to be so obviously against even the travesty of a mockery of a sham of a law regulating supplements (the Dietary Supplement Health and Education Act of 1994, or the DSHEA) that the FDA could take action.

Of course, here at SBM, we’ve written numerous posts on the shortcomings of the DSHEA. Basically, this law created a new class of regulated entities known as dietary supplements and liberalized the sorts of information that supplement manufacturers could transmit to the public. The result has been this:

It [the DSHEA] also expanded the types of products that could be marketed as “supplements.” The most logical definition of “dietary supplement” would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.

One might wonder how such a bad law could survive for so long (seventeen years now), but it has its defenders. One man, in particular, defends the DSHEA against all regulatory threats, foreign and domestic. His name is Senator Orrin Hatch (R-UT), and he was just the subject of a writeup in the New York Times last week referring to him as a “natural ally” of the supplement industry:
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Posted in: Herbs & Supplements, Pharmaceuticals, Politics and Regulation

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Blatant pro-alternative medicine propaganda in The Atlantic

Some of my fellow Science-Based Medicine (SBM) bloggers and I have been wondering lately what’s up with The Atlantic. It used to be one of my favorite magazines, so much so that I subscribed to it for roughly 25 years (and before that I used to read my mother’s copy). In general I enjoyed its mix of politics, culture, science, and other topics. Unfortunately, my opinion changed back in the fall of 2009, when, on the rising crest of the H1N1 pandemic, The Atlantic published what can only be described as an terrible bit of journalism lionizing the “brave maverick doctor” Tom Jefferson of the Cochrane Collaboration. The article, written by Shannon Brownlee and Jeanne Lenzer, argued, in essence, that vaccinating against H1N1 at the time was a horrendous waste of time and effort because the vaccine didn’t work. So bad was the cherry picking of data and framing of the issue as a narrative that consisted primarily of the classic lazy journalistic device of a “lone maverick” against the entire medical establishment that it earned the lovely sarcasm of our very own Mark Crislip, who wrote a complete annotated rebuttal, while I referred to the methodology presented in the article as “methodolatry.” Even public health epidemiologist Revere (who is, alas, no longer blogging but in his day provided a very balanced, science-based perspective on vaccination for influenza, complete with its shortcomings) was most definitely not pleased.

I let my subscription to The Atlantic lapse and have not to this day renewed it.

Be that as it may, last year The Atlantic published an article that wasn’t nearly as bad as the H1N1 piece but was nonetheless pretty darned annoying to us at SBM. Entitled Lies, Damned Lies, and Medical Science, by David Freedman, it was an article lionizing John Ioannidis (whom I, too, greatly admire) while largely missing the point of his work, turning it into an argument for why we shouldn’t believe most medical science. Now, Freedman’s back again, this time with a much, much, much worse story in The Atlantic in the July/August 2011 issue under the heading “Ideas” and entitled The Triumph of New Age Medicine, complete with a picture of a doctor in a lab coat in the lotus position. It appears to be the logical follow up to Freedman’s article about Ioannidis in that Freedman apparently seems to think that, if we can’t trust medical science, then there’s no reason why we shouldn’t embrace medical pseudoscience.

Basically, the whole idea behind the article appears to be that, even if most of alternative medicine is quackery (which it is, by the way, as we’ve documented ad nauseam on this very blog), it’s making patients better because of placebo effects and because its practitioners take the time to talk to patients and doctors do not. In other words, Freedman’s thesis appears to be a massive “What’s the harm?” argument coupled with a false dichotomy; that is, if real doctors don’t have the time to listen to patients and provide the human touch, then let’s let the quacks do it. Tacked on to that bad idea is a massive argumentum ad populum portraying alternative medicine as the wave of the future, in contrast to what Freedman calls the “failure” of conventional medicine.

Let’s dig in, shall we? I’ll start with the article itself, after which I’ll examine a few of the responses. I’ll also note that our very own Steve Novella, who was interviewed for Freedman’s article, has written a response to Freedman’s article that is very much worth reading as well.

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Posted in: Acupuncture, Medical Academia, Medical Ethics, Nutrition, Science and the Media

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Science-based medicine, skepticism, and the scientific consensus

Editor’s note: This weekend was a big grant writing weekend for me. I’m resubmitting my R01, which means that between now and July 1 or so, my life is insanity, as I try to rewrite it into a form that has a fighting chance of being in the top 7%, which is about the level the NCI is funding at right now. This weekend, I buried myself in my Sanctum Sanctorum and tried like heck to try to pound the revision into a really good draft that I can distribute to my colleagues for feedback. Fortunately, I have some old posts that I can pull out, tart up (i.e., update a bit, as in correcting the parts that led me to groan as I reread them, thereby hopefully making them better). I think they’re quite good, if I do say so myself; so hopefully you will too.

There are some arguments made in blogs, articles, or books that strike me so hard that I remember them, even three and a half years later. Sometimes I even file them away for later use or response if the issue raised by them is interesting, relevant or compelling enough to me. Although this topic is a bit broader than many of the topics I write about for this blog, I think it also goes to the heart of science-based medicine and communicating scientific skepticism about medicine to the masses. A few years back, a Swedish blogger named Martin Rundkvist made a rather provocative observation about skepticism. Specifically, he argued that a “real skeptic always sides with scientific consensus.” Among his reasons was this one:

Science presupposes that all participants have a skeptical frame of mind and arrive at conclusions through rational deliberation. If a large group of knowledgeable people working in this way arrive at a consensus opinion, then there is really no good reason for anybody with less knowledge of the subject to question it. Informed consensus is how scientific truth is established. It’s always provisional and open to reevaluation, but as long as there’s informed consensus, then that’s our best knowledge. Humanity’s best knowledge.

Although at the time I saw where Martin was coming from, I found this viewpoint somewhat disturbing, leading me to echo Martin’s own words in response to his own rhetorical question asking whether accepting a scientific consensus is nothing more than “kowtowing to white-coated authority”: Well, yes and no.
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Posted in: History, Medical Academia, Science and Medicine

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