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On the dangers of using valid placebo controls in clinical trials of acupuncture

ResearchBlogging.orgI don’t recall if I’ve ever mentioned this before on this blog, but there was a time when I was less skeptical of acupuncture than I am now. It’s true. Don’t get me wrong, though. I never for a minute considered that the whole rigamarole about “unblocking” or “redirecting” the flow of that mystical life force known as qi had anything to do with whether or not acupuncture did or did not have efficacy treating disease or other conditions. That was clearly a holdover from the pre-scientific medicine times in which most beliefs about the causes of disease involved either the wrath of the gods or vitalism, the latter of which is, when you come right down to it, the philosophical basis upon which many “complementary and alternative” (CAM) modalities are based, especially the so-called “energy healing” modalities, such as reiki, therapeutic touch, and, of course, acupuncture.

However, because unlike so many other “energy healing” methods, acupuncture involved an actual physical action upon the body, namely the insertion of thin needles into the skin to specified depths, it did not seem to me entirely unreasonable that there might be some sort of physiological effect that might produce a therapeutic result. At least, that’s what I used to think until I actually started paying attention to the scientific literature on acupuncture. That’s when I started to realize that “there’s no ‘there’ there,” if you know what I mean. Horribly designed studies with either no controls or utterly inadequate controls tend to be the norm in the acupuncture “literature” (if you can call it that). Moreover, acupuncture was touted as having value for conditions and procedures for which there is no plausible (or even mildly plausible) physiological mechanism by which it could be reasonably postulated to have an effect. Arthritis, allergies, headache, back pain, gastroesophageal reflux disease (GERD), Parkinson’s disease, post-operative nausea, hot flashes in breast cancer patients caused by the anti-estrogen drugs they have to take, infertility, it doesn’t matter. Seemingly acupuncture can do it all; it’s the Swiss Army knife of CAM therapies. Moreover, the “explanations” given to explain “how acupuncture works” seemed increasingly less plausible to me. Most of these explanations involve counterirritation or the release of opioids, and I’ve had an increasingly hard time believing that, even if these mechanisms are at play, they could have anything other than nonspecific effects, with no mechanism to explain how acupuncture could possibly do all things attributed to it. One rule of medical skepticism is that you should be very skeptical of modalities that are touted to be useful for a wide variety of medical conditions that have very different pathophysiology. Indeed, a funny thing happens when rigorous placebo controls are introduced, and that’s sometimes the placebo control does better than the “true” acupuncture; i.e., the evidence for acupuncture, taken in its totality, is completely compatible with placebo effect.

As Harriet Hall put it in her excellent analysis of a study purporting to show that acupuncture is useful for GERD:

This study falls into the category of what I call Tooth Fairy science. You could measure how much money the Tooth Fairy leaves under the pillow, whether she leaves more cash for the first or last tooth, whether the payoff is greater if you leave the tooth in a plastic baggie versus wrapped in Kleenex. You can get all kinds of good data that is reproducible and statistically significant. Yes, you have learned something. But you haven’t learned what you think you’ve learned, because you haven’t bothered to establish whether the Tooth Fairy really exists.

One area that acupuncturists keep needling away at is infertility. Somehow, in the CAM community it’s become conventional wisdom that acupuncture can somehow increase the chance of success for couples undergoing in vitro fertilization (IVF). Indeed, early this year I wrote about a meta-analysis that concluded that acupuncture did actually increase the success rate of IVF and why it did not show what its authors thought it showed. Tooth fairy science, indeed.

Now comes yet another study being publicized in the media that examines once again the question of whether sticking needles into women before they undergo IVF can increase their chances of conceiving. I could not help but be extremely amused by the title given to the ScienceDaily story about it: Placebo Acupuncture Is Associated With Higher Pregnancy Rate After IVF Than Real Acupuncture. You have to love a headline like that, and opening paragraphs like this:
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Posted in: Acupuncture, Clinical Trials, Medical Academia, Science and the Media

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Bad Science: Four Things I Learned From Dr. Ben Goldacre

“You cannot reason people out of positions they didn’t reason themselves into.”

– Ben Goldacre, MD

Dr. Ben Goldacre is the author of the popular Guardian column, Bad Science. He has recently published a book by the same name. Bad Science received a very favorable review from the British Medical Journal and although I was tempted to write my own review for Science Based Medicine, I decided to cherry pick some concepts from the book instead. I hope you’ll enjoy the cherries.

Honesty & Placebos

As you can imagine, any good book about bad science must devote at least one chapter to the concept of placebos. We are all quite familiar with placebos, and how squarely the vast majority (and some would argue all) of complementary and alternative medicines fit into that category.  Ben surprised me with a couple of points that I hadn’t considered previously. Firstly, that alerting patients to the fact that you’re planning to prescribe them a placebo does not necessarily negate its effects, and secondly that no matter how skeptical or intelligent you are – all humans are subject to placebo effects.

Ben references a 1965 study from Johns Hopkins [Park et al., Archives of General Psychiatry] in which patients were explicitly told that they were going to receive a sugar pill (with no medicine in it at all) as treatment for their neuroses. The researchers reported substantial improvements in many of the study subjects’ symptoms.

This is the script that the physicians were to use to explain the placebos to the study subjects:

Mr. Doe… we have a week between now and your next appointment, and we would like to do something to give you some relief from your symptoms. Many different kinds of tranquilizers and similar pills have been used for conditions such as yours, and many of them have helped. Many people with your kind of condition have also been helped by what are sometimes called ‘sugar pills,’ and we feel that a so-called sugar pill may help you too. Do you know what a sugar pill is? A sugar pill is a pill with no medicine in it at all. I think this pill will help you as it has helped so many others. Are you willing to try this pill?

Wow. I was under the impression that the efficacy of the placebo was in the person’s belief that it was a legitimate medicine/therapy. Perhaps it only matters that the prescribing physician believes it might help? Perhaps snake oil salesmen are wasting their time on linguistic and pseudoscientific mental gymnastics?

Of course, the “gymnastics” do help. Other research has shown that the more complex the associated placebo ritual, the more potent its effects (such as piercing the skin with fine needles in many different locations). Nonetheless, I was surprised that an honest and accurate description of a placebo does not necessarily negate its effects.
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Posted in: Book & movie reviews, Herbs & Supplements, Science and the Media

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Robert F. Kennedy, Jr., vaccines, the EPA, and the interface with science-based medicine and public policy

This blog is entitled Science-Based Medicine for a reason, and that’s because we here at SBM believe that the best method to result in the most efficacious treatments for the most people is through the application of science to the evaluation of the biology, pathophysiology, and treatment of disease and disorders.

I may (or may not) be departing a bit from the views of my co-bloggers with this belief, but for purposes of this blog I consider “medicine” to go far beyond what we as physicians do when we undertake to treat patients. In fact, in my view, the purview of science-based medicine should not be so limited but should include any area where decisions, actions, or policy have a direct impact on health. Thus, my definition of science-based medicine encompasses environmental policy, because of the profound effect on human health environmental pollution and toxins can have. Unfortunately for those of us who don’t like its messiness, such a view drives me even more directly into politics than previous issues I’ve taken on. Like Dr. Novella, I rarely write about politics, but when it directly impacts science-based medicine. Mostly, such discussions here on SBM have involved the regulation of the medical profession by government, as Dr. Atwood discussed recently (1, 2, 3) in the context of the difficulties medical boards have in preventing quackery to my discussion of how a quack like Dr. Rashid Buttar could continue to practice in North Carolina, despite his despicable preying upon desperate cancer patients and the parents of children with autism, not to mention the frequent criticisms of the National Center for Complementary and Alternative Medicine. Dr. Sampson, on the other hand, was more than willing to examine a much more explicitly political issue, namely the number of Iraq War dead (1, 2), and that provoked a bit of disagreement with our commenters, not to mention me.

Recently, hot on the heels of the election of Barack Obama in the Presidential election last week, an issue relevant to several aspects of where science-based medicine intersects public policy popped up. Steve Novella has already commented on it on his own blog, as have numerous other medical bloggers, science bloggers, and political bloggers but I feel justified in commenting on it here, for the reasons that I’ve just mentioned. The controversy is that antivaccine activist and true believer in the scientifically discredited notion that mercury in the thimerosal preservative in vaccines causes autism, Robert F. Kennedy, Jr., is being seriously considered by Barack Obama either to head the Environmental Protection Agency or even to be Secretary of the Interior. Like our fearless leader Steve, I believe that such a selection would be an unmitigated disaster for science policy in government.
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Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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Breast cancer and migraines–what is risk, anyway?

ResearchBlogging.orgOne of the questions most often asked in the medical literature is “what is the risk of x?”  It’s a pretty important question.  I’d like to be able to tell my patient with high blood pressure what their risk of heart attack is, both with and without treatment.  And risk is a sexy topic—the press loves it.  Whether it’s cell phones and the “risk” of brain cancer, or vaccines and the “risk” of autism, risk makes for cool headlines.  Take this one for example:

Migraines cut breast cancer risk 30 percent: study

What does this mean?  Should I tell my wife to go out and find some migraines?  I have a feeling one or more of my colleagues will give a more detailed critique of this study, but I’d like to talk to you a bit about what we mean by “risk”.

Risk, in the most basic sense, is a causal association.  If, for example, I find that members of the “Thunderstorm-lovers Golf Association” have a higher incidence of being struck by lightning than golfers who don’t belong to this odd club, I may have stumbled upon a measurable risk.  There is both a measurable association, and a plausible reason to causally link the associated variables.   If I find that members of the National Association of Philatelists have a higher incidence of heart disease than other folks, I may or may not have stumbled on a risk.  Is there a reason that philatelists should have more heart disease?  Is it a coincidence?  Is it worth investigating further?  Is there a confounding variable, e.g. are philatelists in general older, and did I fail to control for this?

Then there is the question of the degree of risk.  How strong is the risk observed?

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Posted in: Science and Medicine, Science and the Media

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“Urban Zen” and homeopathy at Beth Israel Medical Center, or: Dr. Gorski destroys his chances of ever being invited to join the faculty at BIMC or the Albert Einstein College of Medicine

I guess I never really wanted to work in Manhattan anyway. At least, that’s what I keep telling myself.

I mean, why on earth would I want to? What’s the attraction? Living in the heart of it all, all those shows and all those amazing cultural activities, all those world-class restaurants? Being close to Boston, Philadelphia, and other cool East Coast cities, which are all just a quick Acela train ride away? Who cares about those things, anyway?

Apparently I don’t, because I’m about to destroy my chances of working at what has been considered one of the premiere academic hospitals in New York City, specifically Beth Israel Medical Center, an academic affiliate of the Albert Einstein College of Medicine. It’s possible for me to have been ignored when I first included the Albert Einstein College of Medicine and its affliated Continuum Center for Health & Healing in my roll call of shame as a medical center that has not just added woo to its offerings, but actively embraced it. At the time I originally discovered it, though, its offerings seemed limited to fairly mild woo, the usual stuff like acupuncture, what I like to call “gateway modalities” that centers embrace first because they’re relatively tame and commonplace. All too commonly, though, dabbling in gateway modalities leads to the “hard stuff,” outright quackery with zero scientific basis like homeopathy, reflexology, and craniosacral therapy. Such is the pathway an academic medical center follows when it degenerates from science-based medicine to what Dr. R. W. famously dubbed “quackademic medicine,” usually driven by a few famous true believers, which, alas, is exactly what happened at fearless leader Steve Novella’s institution of Yale, thanks to Dr. David Katz and his “more fluid concept of evidence.”

In any case, last week, I realized that I’ve been completely neglecting the aforementioned roll call of shame. Perusing it, I now realize that it’s been over five months since I did a significant update to it. You just know that, given the rate of infiltration of unscientific medical practices into medical academia as seemingly respectable treatment modalities that there must be at least several new additions to this roll of shame. Alas, even today, having been shamed myself by the realization of my failure to keep the list updated, I’m not going to do the full update and revamping that the Roll Call of Quackademic Medicine cries out for. However, that doesn’t mean I can’t do a piecemeal addition here and there. That doesn’t mean I can’t point out new additions as they pop up, even if it takes me a while to find the time to give the list the facelift it cries out for. It doesn’t mean I can’t call out hospitals like Beth Israel when they fall into woo, especially when they dive into quackademic medicine in a big way for cancer patients.
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Posted in: Cancer, Homeopathy, Medical Academia, Science and the Media

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Knowledge Versus Expertise: The View From Consumer Land

“The internet, in democratizing knowledge, has led a lot of people to believe that it is also possible to democratize expertise.”

- SBM Commenter, yeahsurewhatever

I’ve spent the last few years of my life in Internet “Consumer Land,” doing what I can to bring accurate health information directly to patients. Of course, I have been surprised by the push-back, and the demand for misinformation. When I first left full time clinical work, it never occurred to me that people would prefer to read falsehoods when provided a clear choice between truth and error. I guess I was pretty naïve.

Journalist Lesley Stahl provided me with some helpful insights during a recent conference. She explained that the Internet has catalyzed a new method of information transfer – speed trumps accuracy, the line between pundits and journalists is blurred, and anyone who can get to a microphone can become an “expert.” Gone are the days of careful sourcing and fact-checking. And gone is the public trust in “mainstream media.”

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Posted in: Health Fraud, Humor, Public Health, Science and Medicine, Science and the Media

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Placebos in the news again

ResearchBlogging.orgTowards the end of last week, I was contemplating what I would be writing about for Monday. No topic had quite floated my boat, but I hated to dip into the archive of topics I’ve written about before to update a post. After all, I like to be topical whenever possible. Then what to my wondering eyes should appear (yes, I know Christmas is still two months away) but a study in the British Medical Journal by a group lead by Jon C. Tiburt at the Department of Bioethics at the National Institutes of Health in collaboration with investigators at the Osler Institute at Harvard University and the McClean Center for Clinical Medical Ethics at the University of Chicago entitled Prescribing “placebo treatments”: results of national survey of US internists and rheumatologists.

Serendipity? Who cares? The study addresses a very important aspect of science-based medicine.
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Posted in: Herbs & Supplements, Science and Medicine, Science and the Media

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When compassion is outshined by ignorance

In a media-saturated society, public figures have a disproportionate influence on people’s understanding of science and medicine. Most patients see their doctor no more than a couple of times a year, but they watch TV, go online, or read a paper daily. In our newspapers and in our news rooms, dedicated science reporters are becoming vanishingly rare.   A wide range of news sources seep into this gap, but perhaps one of the most unfortunate is the “celebrity health expert”.

Uninformed statements from celebrities are nothing new, but when the queen of the antivaccination movement gets to call someone else stupid, that’s news.

Comedian Dennis Leary did little to advance the cause of humor or medical knowledge when he wrote this:

“There is a huge boom in autism right now because inattentive mothers and competitive dads want an explanation for why their dumb-ass kids can’t compete academically, so they throw money into the happy laps of shrinks . . . to get back diagnoses that help explain away the deficiencies of their junior morons. I don’t give a [bleep] what these crackerjack whack jobs tell you – yer kid is NOT autistic. He’s just stupid. Or lazy. Or both.”

There is no “autism epidemic” as such, but there sure is a lot of ink spilled in ignorance, and Leary certainly seems to have a surfeit of that.  But never fear, Jenny McCarthy will come to the rescue of autistic folks everywhere.

“My fight isn’t with Denis Leary, my fight is with the government — a bigger fish to fry. So I’m still gonna work on the vaccines and I’m still working on pediatricians and Denis Leary can go hopefully be more educated by every mother that stops him from this day forward to give him a piece of their mind,” she said.

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Posted in: Science and the Media, Vaccines

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Dr. Jay Gordon and me: Random encounters with an apologist for the antivaccine movement

27452983Although he doesn’t detest me nearly as much as antivaccine honcho and founder of Generation Rescue J. B. Handley does, Santa Monica celebrity pediatrician Dr. Jay Gordon doesn’t like me very much at all.

Actually, I’m not sure whether that’s entirely true or not, but Dr. Gordon sure doesn’t like it when I criticize him for his antivaccine rhetoric. He affects an oh-so-wounded posture and self-righteously assures me that he is not “anti-vaccine” and that it is “beneath me” to use such rhetoric against him. Whether such rhetoric is “beneath me” or not, however, I’ve never quite understood why Dr. Gordon gets so upset at when I describe him as “anti-vaccine.” After all, his words are frequently apologetics for the anti-vaccine movement, and his actions frequently give it aid and comfort. After all, he is Jenny McCarthy‘s son Evan’s pediatrician, and as a result of that connection he has been giving speeches to antivaccine rallies, such as the “Green Our Vaccines” rally in Washington, D.C. in June. (He is the man in the sunglasses behind Jim Carrey in the picture at the top of this post by me.) After all, he has been palling around with luminaries of the antivaccine movement, such as Jenny McCarthy and her boyfriend Jim Carrey, the aforementioned J. B. Handley, Robert F. Kennedy, Jr., Boyd Haley, and numerous others at events like the “Green Our Vaccines” rally.

But, above all, over the last three or four years, Dr. Gordon has become the go-to pediatrician that the media seemingly always wants to interview when a vaccine “skeptic” with an MD after his name is required to provide the “balance” that journalists worship above all else, even when that “balance” gives undue credence to pseudoscientific nonsense. He clearly relishes that role, too, most infamously on his appearance with Jenny McCarthy on Larry King Live!, in which McCarthy shouted down pro-vaccine physicians and yelled “Bullshit!” (as if she who yells the loudest and is the most foul-mouthed wins the debate) and as evidenced by his appearances on certain antivaccination mailing lists, from which messages are occasionally forwarded to me.

What else am I supposed to think, except that Dr. Jay is at the very least an apologist for the antivaccine fringe, if not a card-carrying member himself?

Unfortunately, Dr. Gordon strikes me as being mostly a nice guy. I say “unfortunately” because it would be much easier to be as harsh on him as his promotion of antivaccine pseudoscience deserves if he were not. He also clearly believes that he is right based on the evidence. Based on science and clinical evidence, he most definitely is not. Recently, I had decided more or less to lay off him for a while, so as to avoid the wounded cries that invariably accompany valid charges that he is an apologist for the antivaccine fringe. Also, I felt kind of bad beating up on him so regularly and thought that perhaps a respite was in order. Then I found out that Dr. Gordon wrote the foreword to Jenny McCarthy’s new antivaccine and pro-autism quackery book, Mother Warriors: A Nation of Parents Healing Autism Against All Odds. Then, one of my readers actually took the time to transcribe Dr. Gordon’s foreword and e-mail it to me.

I read it, and I was appalled.
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Posted in: Neuroscience/Mental Health, Public Health, Science and the Media, Vaccines

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A natural product of his environment

I’m delighted to have the opportunity to join this outstanding group of medical professional bloggers in adding my natural products angle to the application of science-based medicine.  With the exception of Dr. Gorski, who holds MD and PhD degrees, I believe I am the first “only a PhD” to be invited to SBM.  However, I have spent much of my career training, and training with, physician-scientists; so enthusiastic am I about the special qualities of the physician-scientist that I married one (or, rather, she chose to marry me, truth be told.).  Conversely, I view the invitation to write here as a responsibility in representing what my fellow basic scientists bring to bear on discussions of the scientific arguments for and against modalities classified broadly as complementary and alternative medicine or integrative medicine.

Why write about herbal medicines and natural products?

I have long been interested in bringing objective scientific information to the public, perhaps as early as my college years in bars while visiting my working-class hometown of Wallington, NJ, or while shooting darts with Philadelphia cops across from my undergrad apartment.  Any chat I’d have with an old buddy or bartender about drugs, cancer, or drugs and cancer would invariably draw some interest from fellow patrons overhearing my discussions.  These were usually followed by, “Hey, aren’t you Frankie Kroll’s boy?,” or “I’ve heard the government is hiding the cure for cancer – do you have any inside dope on that?”
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Posted in: Herbs & Supplements, Medical Academia, Pharmaceuticals, Science and Medicine, Science and the Media

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