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Archive for Neuroscience/Mental Health

Autism Prevalence Higher than Thought

Crossposted from NeuroLogica Blog

Over the last 20 years the prevalence of autism (now part of autism spectrum disorder, ASD) has been increasing. The medical community is largely agreed that this increase is mostly due to expanding the diagnostic category and greater efforts at surveillance. There remains some controversy over whether or not these factors explain all of the measured increase, or if there is a small real increase hidden in there as well. But largely – we are finding more children with ASD because we are casting a wider net with smaller holes.

If this is true, then we do not yet know what the true prevalence of ASD is. There must be a pool of undiagnosed children out there. Eventually the measured prevalence will hit the ceiling of the true prevalence (unless, of course, we expand the definition further) – but where is the ceiling?

That is the question researchers recently set out to answer, and they did so with a comprehensive 5 year study conducted in South Korea. The results surprised even them:
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Chemical castration of autistic children leads to the downfall of Dr. Mark Geier

One of the most persistent myths is one that’s been particularly and doggedly resistant to evidence, science, clinical trials, epidemiology, and reason. It’s also a myth that I’ve been writing about a long time. Specifically, I’m referring to the now scientifically discredited myth that the mercury-containing thimerosal preservative that used to be in quite a few childhood vaccines causes autism. The myth began in the late 1990s and was later fed by the publication of David Kirby’s book Evidence of Harm, which was basically a paean to various brave maverick doctors who promoted the claim that mercury in vaccines cause autism. Among the “scientists” promoted by David Kirby were the father-son team of Mark and David Geier. Mark Geier is a physician who also has a PhD and represents himself as a medical geneticist; his son David has no medical degree, leading to my wondering from the very beginning how it was that he got away with helping his father evaluate and treat autistic children, in essence practicing medicine without a license.

The Geiers are most infamous for their “Lupron protocol,” which I first learned about back in 2006. As I wrote about it in 2009, when the mainstream media finally noticed the Geiers’ dubious medicine and how they were franchising it to different states, it was chemical castration for autism. The short version is that, somehow some way, Mark Geier got the idea in his head that testosterone contributes to autism. That in and of itself isn’t woo, given that scientists have from time to time hypothesized that very thing. What made the Geiers’ conclusions pseudoscience is their explanation. Basically, Geier claimed that testosterone binds mercury from vaccines, making it more “toxic” to the brain and also making it harder to get rid of the mercury using chelation therapy. Never mind that the only paper showing testosterone binding to mercury did it in benzene (hint: your blood is not benzene) under extreme conditions. What was worse, however, was the Geiers’ “solution” to this problem, which was to add to the autism quackery known as chelation therapy another potentially harmful form of quackery, namely chemical castration using Lupron, a drug that shuts down the production of sex hormones, including testosterone. It’s a drug that’s used to treat metastatic prostate cancer, a treatment that replaced the old treatment for metastatic prostate cancer, namely surgical castration. (Not coincidentally, it’s also used to chemically castrate sex offenders.) Even worse still, the Geiers somehow got away with a highly unethical clinical trial in which they packed the Institutional Review Board overseeing it with their cronies, going merrily on their way offering an unethical “clinical trial” untouched and seemingly untouchable.
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“Motivated reasoning,” alternative medicine, and the anti-vaccine movement

One theme that we at Science-Based Medicine keep revisiting again and again is not so much a question of the science behind medical therapies (although we do discuss that issue arguably more than any other) but rather a question of why. Why is it that so many people cling so tenaciously to pseudoscience, quackery, and, frequently, conspiracy theories used by believers to justify why various pseudoscience and quackery are rejected by mainstream science and medicine? Certainly, I’ve touched on this issue before on several occasions, for example, with respect to the anti-vaccine movement, the claim that abortion causes breast cancer, and how we as humans crave certainty.

It turns out that science and science-based medicine are hard for humans to accept because they often conflict with what our senses perceive and brains interpret as irrefutable evidence. The pattern-seeking function of our brain, when evaluating questions of causation in medicine, frequently betrays us. For instance, when a parent sees her child regress into autism sometime not long after being vaccinated, the easiest, most instinctive, and most emotionally compelling conclusion is that the vaccine must have had something to do with it. When scientists tell her that, no, in large studies looking at hundreds of thousands of children, there is no good evidence that vaccination confers an increased risk of autism and a lot of evidence that it does not, it’s a very hard message to believe, because it goes against how the parent interprets what she’s seen with her own eyes. Indeed, how often have we seen believers in the vaccine-autism link pour derision on the concept that when something like autistic regression happens in close temporal proximity to vaccination that the correlation does not necessarily equal causation? Similarly, believers in “alternative medicine” who experience improvement in their symptoms also pour derision on the observation, explained so well by R. Barker Bausell in Snake Oil Science, that people frequently take remedies when their symptoms are at their worst, leading them to attribute natural regression to the mean to whatever nostrum they started taking at the time.

These issues have come to the fore again, thanks to an article by an acquaintance of mine, Chris Mooney, author of The Republican War on Science, Storm World: Hurricanes, Politics, and the Battle Over Global Warming, and Unscientific America: How Scientific Illiteracy Threatens our Future (co-authored with Sheril Kirshenbaum). The article appeared in a recent issue of Mother Jones and was entitled, rather ironically, The Science of Why We Don’t Believe Science. Chris made his name as an author primarily in writing about the science of anthropogenic global warming and the political battles over policies intended to mitigate it and, to a lesser extent, over creationism and evolution denial. Of late he has written about the anti-vaccine movement as an anti-science movement, leading predictably to his being attacked by the likes of J.B. Handley as viciously as I and others have. Also of note, although he was widely praised for The Republican War on Science and Storm World, Mooney has been widely criticized in some circles for being too critical of “new atheists” and for lack of substance. In his current article, he discusses some of the science thus far about why people can cling to beliefs that science doesn’t just cast doubt upon but shows convincingly are totally wrong.
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Posted in: Evolution, Neuroscience/Mental Health, Pharmaceuticals, Politics and Regulation, Science and the Media, Vaccines

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CCSVI Update

I have been following the story of Dr. Zamboni, an Italian vascular surgeon who claims that multiple sclerosis (MS) is primarily caused by blockages in the veins that drain blood from the brain. This results in backup of blood in the brain, leading to inflammation around the blood vessels and MS. He sought to find the cause and cure for MS because his wife suffers from this disease – and he claims to have found one in his own specialty.

New ideas are presented in science and medicine all the time. This is healthy and necessary – we have to keep churning the pot so that new ideas can emerge and our thinking does not become calcified. But science is both a creative and destructive process, and most new ideas fall victim to the meatgrinder of research and peer-review. Ideally this process will take place mostly within the halls of science, and then those ideas that survive at least initial examination will start to penetrate the broader culture.

This is not what often happens today, however. With the internet and mass media, preliminary speculative studies are often presented to the public as if they are a stunning breakthrough. When the scientific community responds with their typical and completely appropriate skepticism, this may lead some to think that they are being stodgy or dogmatic, or even that a cover-up is in the works. The originator of the speculative claim is usually portrayed as a brave maverick, although sometimes the story can be framed as, “Brilliant scientist or dangerous crank? You decide.” When the topic is a new medical treatment, the stakes can be quite high. In this case many patients with progressive MS are seeking treatment with the so-called liberation procedure to treat the highly speculative CCSVI as an alleged cause for their MS.

This story has all the makings of the kind of scientific and medical drama the mass media loves. While the controversy rages, the science is quietly being done in the background, and the results are not heading in a favorable direction for Zamboni. A recent study, the largest to date, drives a further stake into the heart of CCSVI as a cause of MS.

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EMDR and Acupuncture – Selling Non-specific Effects

The scientific approach to understanding the world includes the process of carefully separating out variables and effects. Experiments, in fact, are designed specifically to control for variables. This can be especially challenging in medicine, since the body is a complex and variable system and there are always numerous factors at play. We often characterize the many variables that can influence the outcome in a clinical study as “placebo effects” or “non-specific effect” – things other than a specific response to the treatment in question.

A common error to make when interpreting clinical studies is to confuse non-specific effects – those that result from the therapeutic interaction or the process of observation – with a specific effect from the treatment being studied. While this is broadly understood within the scientific medical community, it seems that within certain fields proponents are going out of their way to sell non-specific effects as if they were specific effects of the favored treatment.

This is perhaps most true for acupuncture. As has been discussed numerous times on SBM, the consensus of the best clinical studies on acupuncture show that there is no specific effect of sticking needles into acupuncture points. Choosing random points works just as well, as does poking the skin with toothpicks rather than penetrating the skin with a needle to elicit the alleged “de qi”.

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Posted in: Acupuncture, Clinical Trials, Neuroscience/Mental Health

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The Dark Side of Medical Globalization

“You are not going to change what we do, you’re not going to change our determination to make these patients better. I see these patients, I know these patients, I value these patients, I’ve looked after them for years. I’ve seen them after the procedure, the vast majority are improved.”

The above quote could be a reference to just about any fringe medical treatment. It is partly an expression of faith in anecdotal experience over scientific evidence. It is partly the fallacy of justifying a treatment because it is needed – whereas the real question is whether or not the treatment works. It is an attempt to justify specific claims with compassion, as if the person quoted cares more for the health of their patients than those who might be skeptical of their claims. And it is an expression of stubbornness – I know the truth, so don’t confuse me with evidence and logic.

Is this person talking about acupuncture? Perhaps they run a stem cell clinic in China, India or somewhere outside the reach of regulation. Or maybe they are defending hyperbaric oxygen therapy for unproven indications, like autism. It could be anything, because this sentiment is the standard mantra of the dubious practitioner, practicing outside the bounds of science-based medicine.

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Placebo Effect for Pain

It has long been recognized that there are substantial multifactorial placebo effects that create real and illusory improvements in response to even an inactive treatment. There is a tendency, however (especially in popular discussion), to oversimplify placebo effects – to treat them as one mind-over-matter effect for all outcomes. Meanwhile researchers are elucidating the many mechanisms that go into measured placebo effects, and the differing magnitude of placebo effects for different outcomes.

For example, placebo effects for pain appear to be maximal, while placebo effects for outcomes like cancer survival appear to be minimal.

A recent study sheds additional light on the expectation placebo effect for pain. The effect is, not surprisingly, substantial. However it does not extrapolate to placebo effects for outcomes other than pain, and the results of this very study give some indication why. From the abstract:

The effect of a fixed concentration of the μ-opioid agonist remifentanil on constant heat pain was assessed under three experimental conditions using a within-subject design: with no expectation of analgesia, with expectancy of a positive analgesic effect, and with negative expectancy of analgesia (that is, expectation of hyperalgesia or exacerbation of pain).

What they found was that the positive expectation group reported twice the analgesic effect as the no expectation group, and the negative expectation group reported no analgesic effect. This is a dramatic effect, but not surprising.

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The Flu Vaccine and Narcolepsy

Last year it was reported that there was a possible increase in narcolepsy, a sleep disorder characterized by excessive sleepiness, in children who had received the Pandemrix brand of H1N1 flu vaccine in Sweden, Finland, and Iceland. However a review of the data did not find a convincing connection, although concluded there was insufficient data at present and recommended further surveillance. A narcolepsy task force was formed in Finland, and now we have their preliminary report.

They conclude that the evidence suggests there is a connection:

Based on the preliminary analyses, the risk of falling ill with narcolepsy among those vaccinated in the 4-19 years age group was 9-fold in comparison to those unvaccinated in the same age group. This increase was most pronounced among those 5–15 years of age. No cases were observed among those under 4 years of age. Also, no increase in cases of narcolepsy or signs of vaccination impacting risk of falling ill with narcolepsy was observed among those above 19 years of age.

The World Health Organization (WHO) has reviewed these results and concluded:

WHO’s Global Advisory Committee on Vaccine Safety (GACVS) reviewed this data by telephone conference on 4 February 2011. GACVS agrees that further investigation is warranted concerning narcolepsy and vaccination against influenza (H1N1) 2009 with Pandemrix and other pandemic H1N1 vaccines. An increased risk of narcolepsy has not been observed in association with the use of any vaccines whether against influenza or other diseases in the past. Even at this stage, it does not appear that narcolepsy following vaccination against pandemic influenza is a general worldwide phenomenon and this complicates interpretation of the findings in Finland.

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“Piltdown medicine” and Andrew Wakefield’s MMR vaccine fraud

Pity poor Andrew Wakefield. Well, not really. I tend to view what’s happening to him yet again as the chickens coming home to roost.

Let’s put it this way. 2010 was a terrible year for him, and 2011 is starting out almost as bad. In February 2010, the General Medical Council in the U.K. recommended that Wakefield be stripped of his license to practice medicine in the U.K. because of scientific misconduct related to his infamous 1998 case series published in The Lancet, even going so far as to refer to him as irresponsible and dishonest, and in May 2010 he was. This case series, thanks to Wakefield’s scientific incompetence and fraud, coupled with his flair for self-promotion and enabled by the sensationalistic credulity of the British press, ignited a scare about the measles-mumps-rubella (MMR) vaccine in which, afraid that the MMR vaccine causes autism, parents in the U.K. eschewed vaccinating their children in droves. As a result, vaccination rates plummeted far below the level necessary for herd immunity, with the entirely predictable result of massive measles outbreaks in the U.K. Measles, which as of the mid-1990s had been declared under control by British and European health authorities, came roaring back to the point where in 2008 it was declared once again endemic in the British Isles. In a mere decade and a half, several decades of progress in controlling this scourge had been unravelled like a thread hanging off a cheap dress, all thanks to Andrew Wakefield and scandal mongers in the British press.

True, Wakefield had long since moved to Texas, the better to be the founding “scientific director” of a house of autism woo known as Thoughtful House. Thus, the removal of his license to practice had little practical import (or effect on his ability to earn a living), or so it seemed at the time, given that Wakefield did not treat patients and hauled in quite the hefty salary for his promotion of anti-vaccine pseudoscience. Fortunately, karma’s a bitch, and, as a result of the GMC’s action, in short order The Lancet retracted Wakefield’s 1998 paper; Wakefield was pushed out of Thoughtful House; and his latest attempt to “prove” that vaccines cause autism in an animal study was also retracted. Investigative reporter Brian Deer’s investigation finding that Andrew Wakefield had committed scientific fraud in carrying out his Lancet study joined prior findings that Wakefield had been in the pocket of trial lawyers (to the tune of £435 643, plus expenses) seeking to sue the vaccine industry at the time he carried out his “research” and the allegations by renowned PCR expert Stephen Bustin during the Autism Omnibus as to how shoddily Wakefield’s other research was carried out. Finally, the mainstream media started to back away from its previous embrace of Wakefield and his claims. As a result, for a while at least, Wakefield was reduced to lame appearances at sparsely attended anti-vaccine rallies last spring.
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Posted in: Health Fraud, Neuroscience/Mental Health, Vaccines

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Placebo effects without deception? Well, not exactly…

In discussing “alternative” medicine it’s impossible not to discuss, at least briefly, placebo effects. Indeed, one of the most common complaints we at SBM voice about clinical trials of alternative medicine is the lack of adequate controls — meaning adequate controls for placebo and nonspecific effects. Just type “acupuncture” in the search box in the upper left hand corner of the blog masthead, and you’ll pull up a number of discussions of acupuncture clinical trials that SBM bloggers have written over the last three years. If you check some of these posts, you’ll find that in nearly every case we spend considerable time and effort discussing whether the placebo or sham control used was adequate, noting that, the better the sham controls, the less likely acupuncture studies are to have a positive result.

Some of the less clueless advocates of “complementary and alternative medicine” (CAM) seem to realize that much of what they do relies on placebo effects. As a result, they tend to argue that what they do is useful and good because it’s “harnessing the placebo effect” for therapeutic purpose. One problem that advocates of SBM (like those of us at SBM who have taken an interest in this topic) tend to have with this argument is that it has always been assumed that a good placebo requires on some level at least some deception of the patient by either saying or implying that he is receiving an active treatment or medicine of some kind. This, we have argued, is a major ethical problem in using placebos in patients, and advocates of placebo medicine appear to agree, because they frequently argue that placebo effects can be harnessed without deception. Indeed, just last week there was an example of this argument plastered all over multiple news outlets and blogs in the form of stories and posts with headlines and titles like:

Except for one, every one of these articles or blog posts discussing a new study in PLoS ONE that purports to have found that placebo effects can be elicited in irritable bowel syndrome (IBS) without deception buys completely into that very thesis. For example, here is an example, taken from the Reuters story about this study:

Placebos can help patients feel better, even if they are fully aware they are taking a sugar pill, researchers reported on Wednesday on an unusual experiment aimed to better understand the “placebo effect.”

Nearly 60 percent of patients with irritable bowel syndrome reported they felt better after knowingly taking placebos twice a day, compared to 35 percent of patients who did not get any new treatment, they report in the Public Library of Science journal PLoS ONE.

“Not only did we make it absolutely clear that these pills had no active ingredient and were made from inert substances, but we actually had ‘placebo’ printed on the bottle,” Ted Kaptchuk of Harvard Medical School and Beth Israel Deaconess Medical Center in Boston, who led the study, said in a statement.

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