Science-Based Medicine

I realize that the New England Journal of Medicine (NEJM) review of acupuncture has already been covered by Drs. Gorski and Novella. But my ego knows no bounds; so I thought I would add my two cents, especially since this review, more than any paper I have read, generates a deep sense on betrayal.

There was a time when I believed my betters. Then the Annals of Internal Medicine had their absolutely ghastly series on SCAMS, the publication of which was partly responsible for interest in the topic. Since that series of articles, I have doubt whenever I read an Annals article. When a previously respected journal panders completely to woo, they lose all respectability. Sure, the editors that were responsible for that travesty are long gone, but the taint remains. I tell my kids that once a trust has been violated, it is difficult to get it back. The Annals has permanently lost my trust, I am afraid.

But we will always have Paris. I mean the NEJM. The NEJM is the premier medical journal. Just because an article is published in the NEJM doesn’t mean it’s right; the results of clinical trials are always being superseded by new information. But the article has supposedly been rigorously peer reviewed. Its like Harvard and… Oops, Bad example. Harvard, as we have seen, has feet of clay, and so, evidently, does the The New England Journal of Medicine.

Goodness, gracious, great balls of fire, the editors of the NEJM have fallen into the depths of nonsense with this one.

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Here is the conclusion quoted from a recent New England Journal of Medicine (NEJM) review article on acupuncture for back pain:

As noted above, the most recent wellpowered clinical trials of acupuncture for chronic low back pain showed that sham acupuncture was as effective as real acupuncture. The simplest explanation of such findings is that the specific therapeutic effects of acupuncture, if present, are small, whereas its clinically relevant benefits are mostly attributable to contextual and psychosocial factors, such as patients’ beliefs and expectations, attention from the acupuncturist, and highly focused, spatially directed attention on the part of the patient.

Translation – acupuncture does not work. Why, then, are the same authors in the same paper recommending that acupuncture be used for chronic low back pain? This is the insanity of the bizarro world of CAM (complementary and alternative medicine). Yesterday David covered the same article, which I had also covered on NeuroLogica, but we both thought this issue important enough to document our thoughts and objections on SBM.

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One of my goals in writing for this blog is to educate the general public about how to evaluate a scientific study, specifically medical studies. New studies are being reported in the press all the time, and the analysis provided by your average journalist leaves much to be desired. Generally, they fail to put the study into context, often get the bottom line incorrect, and then some headline writer puts a sensationalistic bow on top.

In addition to mediocre science journalism we also face dedicated ideological groups who go out of their way to spin, distort, and mutilate the scientific literature all in one direction. The anti-vaccine community is a shining example of this – they can dismiss any study whose conclusions they do not like, while promoting any horrible worthless study as long as it casts suspicion on vaccines.

Yesterday on Age of Autism (the propaganda blog for Generation Rescue) Mark Blaxill gave us another example of this, presenting a terrible pilot study as if we could draw any conclusions from it. The study is yet another publication apparently squeezed out of the same data set that Laura Hewitson has been milking for several years now - a study involving macaque infants and vaccinations. In this study Hewitson claims a significant difference in brain maturation between vaccinated and unvaccinated macaque infants, by MRI and PET analysis. Blaxill presents the study without noting any of its crippling limitations, and the commenters predictably gush.

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Autism and autism spectrum disorders (ASDs) actually represent a rather large continuum of conditions that range from very severe neurodevelopmental delay and abnormalities to the relatively mild. In severe cases, the child is nonverbal and displays a fairly well-characterized set of behaviors, including repetitive behaviors such as “stimming” (for example, hand flapping, making sounds, head rolling, and body rocking.), restricted behavior and focus, ritualistic behavior, and compulsive behaviors. In more mild cases, less severe compulsion, restriction of behavior and focus, and ritualistic behaviors do not necessarily preclude functioning independently in society, but such children and adults may have significant difficulties with social interactions and communication. Because ASDs represent a wide spectrum of neurodevelopmental disorders whose symptoms typically first manifest themselves to parents between the ages of two and three, the idea that vaccines cause autism and ASDs has been startlingly difficult to dislodge and has fueled an anti-vaccine movement, both here in the U.S. and in other developed nations, particularly the U.K. and Australia. This movement has been stubbornly resistant to multiple scientific studies that have failed to find any link between vaccines in autism or the other favorite bogeyman of the anti-vaccine movement, the mercury-containing thimerosal preservative that used to be in many childhood vaccines in the U.S. until the end of 2001. Add to that the rising apparent prevalence of ASDs, and, confusing correlation with causation, the anti-vaccine movement concludes that vaccines must be the reason for the “autism epidemic.”

In reality, autism and ASDs appear to be increasing in prevalence due to diagnostic substition, better screening, and the broadening of the diagnostic criteria that occurred in 1994. Autism prevalence does not appear to be rising, at least not dramatically, at all, as the prevalence of ASDs, when assessed carefully, appears to be similar in adults as it is in children. If the true prevalence rate of autism and ASDs has increased, it has not increased by very much. In reality autism appears to have a major and probably predominant genetic component, and several scientific studies over the last few years have linked autism with various genetic abnormalities. Not surprisingly, given the varied presentation and severity of ASDs, these studies have not managed to identify single genes that produce autism or ASDs with a high degree of penetrance (probability of causing the phenotype if the gene is present). Indeed, one can argue that the state of current evidence is that ASDs are due to multiple genes, perhaps dozens or hundreds. Again, this is not surprising given the heterogeneity of ASD severity, presentation, and symptoms.

One of the more surprising studies supporting a genetic basis for autism appeared to much fanfare in Nature last week. The study by Pinto et al, looks at the functional impact of global rare copy number variation in autism spectrum disorders. Its results are rather surprising in that the large team of investigators (studies of this type take a lot of people to carry out) found that it may be relatively uncommon copy number variations in various genes that lead to the phenotype of autism or ASDs.
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The development of drugs and other treatments for specific symptoms or conditions relies heavily on either serendipity (the chance finding of a beneficial effect) or on an understanding of underlying mechanisms. In pain, for example, there are limited ways in which we can block pain signals – such as activating opiate receptors or inhibiting prostaglandins. There are only so many ways in which you can interact with these systems. The discovery of a novel mechanism of modulating pain is therefore most welcome, and has the potential of leading to entirely new treatments that may have better side-effect profiles than existing treatments and also have additive clinical effects.

A recent study by Nana Goldman et. al., published in Nature Neuroscience, adds to our understanding of pain relief by identifying the role of adenosine in reducing pain activity in the peripheral nervous system. The researchers, in a nice series of experiments, demonstrated that producing a local painful stimulus in mice causes the local release of ATP (adenosine triphosphate) that peaks at about 30 minutes. This correlates with a decreased pain response in the mice. Further, if drugs are given that prolong the effect of adenosine, the analgesic effect itself is prolonged.

Also, if drugs are given that activate the adenosine A1 receptor, the observed analgesic effect is replicated. When these experiments are replicated in knockout mice that do not have the gene for the adenosine A1 receptor, there is no observed analgesic effect.

Together these experiments are fairly solid evidence that local pain results in the local release of adenosine that in turn binds to the adenosine A1 receptor inhibiting the pain response. This is potentially very exciting – it should lead to further investigation of the adenosine A1 receptor and the effects of activating and inhibiting it. This may lead to the development of drugs or other interventions that activate these receptors and may ultimately be a very useful addition to our ability to treat acute and chronic pain.

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Two recent acupuncture studies have received some media attention, both purporting to show positive effects. Both studies are also not clinical efficacy trials, so cannot be used to support any claims for efficacy for acupuncture – although that is how they are often being presented in the media.

These and other studies show the dire need for more trained science journalists, or science blogging – they only make sense when put into a proper context. No media coverage I read bothered to do this.

The first study comes out of South Korea and involves using acupuncture in a rat model of spinal cord injury. The researchers used a standard method of inducing spinal cord injury in rats, and compared various acupuncture locations to no-acupuncture control. They followed a series of metabolic outcomes, as well as the extent of spinal cord injury and functional recovery. They conclude:

Thus, our results suggest that the neuroprotection by acupuncture may be partly mediated via inhibition of inflammation and microglial activation after SCI and acupuncture can be used as a potential therapeutic tool for treating acute spinal injury in human.

The notion that acupuncture will actually improve outcome after acute spinal cord injury is, of course, extraordinary. This goes far beyond a subjective decrease in pain or some other symptomatic benefit. Therefore similarly extraordinary evidence should be required to support such a claim – and this study does not provide that.

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An article entitled “The Burden of Suboptimal Breastfeeding in the United States: A Pediatric Cost Analysis,” by Bartick and Reinhold, was published in Pediatrics 2010 April 5. According to this news report, it showed that 900 babies’ lives and billions of dollars could be saved every year in the U.S. if we could get 90% of mothers to breastfeed for at least 6 months. It says breastfeeding has been shown to reduce the risk of stomach viruses, ear infections, asthma, juvenile diabetes, Sudden Infant Death Syndrome and even childhood leukemia.

This new study did not provide any new evidence. It simply took risk ratios from a three year old government report, extrapolated, and estimated the costs.
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Over the past two plus years of the existence of Science-Based Medicine (SBM) we have been highly critical of the National Center for Complementary and Alternative Medicine (NCCAM) – going so far as to call for it to be abolished. We are collectively concerned that the NCCAM primarily serves as a means for promoting unscientific medicine, and any useful research it funds can be handled by other centers at the NIH.

So we were a bit surprised when the current director of the NCCAM, Josephine Briggs, contacted us directly and asked for a face-to-face meeting to discuss our concerns.

That meeting took place this past Friday, April 2nd. David Gorski, Kimball Atwood and I met with Dr. Briggs, Deputy Director Dr. John Killen, Karin Lohman PhD (Director, Office of Policy, Planning, and Evaluation) and Christy Thomsen (Director, Office of Communications and Public Liaison).

Dr. Briggs very graciously began the meeting by telling us that she and her staff have been reading SBM and they find our arguments to be cogent and serious. She shares many of our concerns, and feels that we are an important voice and are having an impact. She then essentially turned it over to us to discuss our primary concerns regarding the NCCAM.

We were prepared for this.

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In the Wall Street Journal last week was a particularly bad article by Melinda Beck about acupuncture. While there was token skepticism (by Edzard Ernst, of course, who is the media’s go-to expert for CAM), the article credulously reported the marketing hype of acupuncture proponents.

Toward the end of the article Beck admits that “some critics” claim that acupuncture provides nothing more than a placebo effect, but this was followed by the usual canard:

“I don’t see any disconnect between how acupuncture works and how a placebo works,” says radiologist Vitaly Napadow at the Martinos center. “The body knows how to heal itself. That’s what a placebo does, too.”

That is a bold claim, and very common among CAM proponents, especially acupuncturists. As the data increasingly shows that acupuncture (and other implausible treatments) provides no benefit beyond placebo, we hear the special pleading that placebos work also.

But is that true? It turns out there is a literature on the placebo effect itself, and the evidence suggests that placebos generally do not work.

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One of the basic principles of science-based medicine is that a single study rarely tells us much about any complex topic. Reliable conclusions are derived from an assessment of basic science (i.e prior probability or plausibility) and a pattern of effects across multiple clinical trials. However the mainstream media generally report each study as if it is a breakthrough or the definitive answer to the question at hand. If the many e-mails I receive asking me about such studies are representative, the general public takes a similar approach, perhaps due in part to the media coverage.

I generally do not plan to report on each study that comes out as that would be an endless and ultimately pointless exercise. But occasionally focusing on a specific study is educational, especially if that study is garnering a significant amount of media attention. And so I turn my attention this week to a recent study looking at acupuncture in major depression during pregnancy. The study concludes:

The short acupuncture protocol demonstrated symptom reduction and a response rate comparable to those observed in standard depression treatments of similar length and could be a viable treatment option for depression during pregnancy.

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