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Archive for Neuroscience/Mental Health

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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Posted in: Neuroscience/Mental Health

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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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Posted in: Neuroscience/Mental Health, Science and 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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Posted in: Neuroscience/Mental Health, Pharmaceuticals

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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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Posted in: Neuroscience/Mental Health, Vaccines

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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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Posted in: Clinical Trials, Neuroscience/Mental Health, Pharmaceuticals, Science and the Media

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Freeways, autism, and correlation versus causation

I have a love-hate relationship with epidemiology.

On the one hand, I love how epidemiology can look for correlations in huge sample sizes, sample sizes far larger than any that we could ever have access to in clinical trials, randomized or other. I love the ability of epidemiology to generate hypotheses that can be tested in the laboratory and then later in clinical trials. Also, let’s not forget that epidemiology is sometimes the only tool available to us that can answer some questions. Such questions generally involve hypotheses that can’t be tested in a randomized clinical trial because of either ethical concerns or others. A good example of this is the question of whether vaccines cause autism. For obvious ethical reasons, it’s not permissible to perform a randomized clinical trial in which one group of children is vaccinated and one is not, and then outcomes with respect to neurodevelopmental outcomes, such as autism and autism spectrum disorders, are tracked in the two groups. The ethical concern with such a study, of course, is the potential harm that would be likely to come to the unvaccinated control group, children who would be left unprotected against common and postentially deadly communicable diaseases.

On the other hand, epidemiology is one of the messiest of sciences, and epidemiological studies are among the most difficult in all of science to perform truly rigorously. The number of factors that can confound are truly amazing, and as a result, it’s very, very easy for an epidemiological study to detect apparent correlations that are either spurious or appear much stronger than the “true” correlation. There can be confounding factors beneath confounding factors wrapped in more confounding factors, the relationships among which are not always apparent. Not infrequently, a condition can appear to be correlated with, for instance, an environmental factor, but in reality that environmental factor and the condition both correlate with a third, unknown confounder. Worse, epidemiologists know that correlation does not necessarily equal causation, but the general public, for the most part, does not, which is why, when anti-vaccine activists, for instance, point out to a rising autism prevalence and then point out that autism prevalence started rising around the same time the vaccine schedule was expanded, to the average layperson the argument sounds compelling. As a result, the design of an epidemiological study is paramount in order to account for or minimize such factors. That’s why I always said I can’t be an epidemiologist. Even though I was very good at math in college, the statistics still made my brain hurt, and I don’t have the patience for the messiness of trying to account for all the possible confounding factors.

However, for all their strengths and flaws, epidemiological studies are an integral part of science-based medicine. They are used to identify predisposing factors to diseases and conditions, environmental contributors to disease, and adverse reactions to drugs, among many other useful pieces of data. That’s why, from time to time, I like to examine epidemiological studies, particularly if they’re epidemiological studies that are getting a lot of press.

The use and abuse of autism epidemiology studies

For instance, studies like this one described in a story in the Los Angeles Times on Friday entitled Proximity to freeways increases autism risk, study finds: More research is needed, but the report suggests air pollution could be a factor:
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Posted in: Epidemiology, Neuroscience/Mental Health, Public Health, Vaccines

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Chronic Pain: A Disease in its Own Right

Melanie Thernstrom has written a superb book based on a historical, philosophical, and scientific review of pain: The Pain Chronicles: Cures, Myths, Mysteries, Prayers, Diaries, Brain Scans, Healing, and the Science of Suffering. Herself a victim of chronic pain, she brings a personal perspective to the subject and also includes informative vignettes of doctors and patients she encountered at the many pain clinics she visited in her investigations. She shows that medical treatment of pain is suboptimal because most doctors have not yet incorporated recent scientific discoveries into their thinking, discoveries indicating that chronic pain is a disease in its own right, a state of pathological pain sensitivity.

Chronic pain often outlives its original causes, worsens over time, and takes on a puzzling life of its own… there is increasing evidence that over time, untreated pain eventually rewrites the central nervous system, causing pathological changes to the brain and spinal cord, and that these in turn cause greater pain. Even more disturbingly, recent evidence suggests that prolonged pain actually damages parts of the brain, including those involved in cognition. (more…)

Posted in: Book & movie reviews, Neuroscience/Mental Health

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PTSD Breakthrough?: It’s Not Science Just Because Someone Says So

It infuriates me when someone misappropriates the word “science” to promote treatments that are not actually based on science. I have just read a book entitled The PTSD Breakthrough: The Revolutionary Science-Based Compass Reset Program by Dr. Frank Lawlis, a psychologist who is the chief content advisor for Dr Phil and The Doctors. There is very little science in the book and references are not provided. It amounts to an indiscriminate catalog of everything Dr. Lawlis can imagine that might help post-traumatic stress disorder (PTSD) patients.  (more…)

Posted in: Book & movie reviews, Neuroscience/Mental Health

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