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.


Posted in: Neuroscience/Mental Health, Vaccines

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Ear Infections: To Treat or Not to Treat

Ear infections used to be a devastating problem. In 1932, acute otitis media (AOM) and its suppurative complications accounted for 27% of all pediatric admissions to Bellevue Hospital. Since the introduction of antibiotics, it has become a much less serious problem. For decades it was taken for granted that all children with AOM should be given antibiotics, not only to treat the disease itself but to prevent complications like mastoiditis and meningitis.

In the 1980s, that consensus began to change. We realized that as many as 80% of uncomplicated ear infections resolve without treatment in 3 days. Many infections are caused by viruses that don’t respond to antibiotics. Overuse of antibiotics leads to the emergence of resistant strains of bacteria. Antibiotics cause side effects. A new strategy of watchful waiting was developed.


Posted in: Clinical Trials, Pharmaceuticals

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The NCCAM Strategic Plan 2011-2015: The Good, The Bad, and The Ugly

As hard as it is to believe, it’s been nearly a year since Steve Novella, Kimball Atwood, and I were invited to meet with the director of the National Center for Complementary and Alternative Medicine (NCCAM), Dr. Josephine Briggs. Depending upon the day, sometimes it seems like just yesterday; sometimes it seems like ancient history. For more details, read Steve’s account of our visit, but the CliffsNotes version is that we had a pleasant conversation in which we discussed our objections to how NCCAM funds dubious science and advocacy of complementary and alternative medicine (CAM). When we left the NIH campus, our impression was that Dr. Briggs is well-meaning and dedicated to increasing the scientific rigor of NCCAM studies but doesn’t understand the depths of pseudoscience that constitute much of what passes for CAM. We were also somewhat optimistic that we had at least managed to communicate some of our most pressing practical concerns, chief among which is the anti-vaccine bent of so much of CAM and how we hoped that NCCAM would at least combat some of that on its website.

Looking at the NCCAM website, I see no evidence that there has been any move to combat the anti-vaccine tendencies of CAM by posting pro-vaccination pieces or articles refuting common anti-vaccine misinformation. Of all the topics we discussed, it was clearest that everyone, including Dr. Briggs, agreed that the NCCAM can’t be perceived as supporting anti-vaccine viewpoints, and although it doesn’t explicitly do so, neither does it do much to combat the anti-vaccine viewpoints so ingrained in CAM. As far as I’m concerned, I’m with Kimball in asserting that NCCAM’s silence on the matter is in effect tacit approval of anti-vaccine viewpoints. Be that as it may, not long afterward, Dr. Briggs revealed that she had met with homeopaths around the same time she had met with us, suggesting that we were simply brought in so that she could say she had met with “both sides.” Later, she gave a talk to the 25th Anniversary Convention of the American Association of Naturopathic Physicians (AANP), which is truly a bastion of pseudoscience.

In other words, I couldn’t help but get the sinking feeling that we had been played. Not that we weren’t mildly suspicious when we traveled to Bethesda, but from our perspective we really didn’t have a choice: if we were serious about our mission to promote science-based medicine, Dr. Briggs’ was truly an offer we could not refuse. We had to go. Period. I can’t speak for Steve or Kimball, but I was excited to go as well. Never in my wildest dreams had it occurred to me that the director of NCCAM would even notice what we were writing, much less take it seriously enough to invite us out for a visit. I bring all this up because last week NCCAM did something that might provide an indication of whether it’s changed, whether Dr. Briggs has truly embraced the idea that rigorous science should infuse NCCAM and all that it does, let the chips fall where they may. Last week, NCCAM released its five year strategic plan for 2011 to 2015.

Truly, it’s a case of The Good, The Bad, and The Ugly.

Posted in: Basic Science, Clinical Trials, Politics and Regulation

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Randi issues a challenge

Lest I be left out of the fun, I can’t help but point out that yesterday the Amazing One himself, James Randi, issued a challenge to manufacturers of homeopathic remedies and retail pharmacies that sell such remedies, in particular large national chains like Walgreens and CVS and large national chains that include pharmacies in their stores, such as Walmart and Target. This was done in conjunction with the 10:23 Challenge, which is designed to demonstrate that homeopathy is nonsense. All over the world, skeptics and supporters of science-based medicine gathered to engage in overdoses of homeopathic medicines in order to demonstrate that there is nothing in them.

As much as I like Randi, unfortunately, I doubt that the prospect of winning $1 million will make much difference to huge companies like Boiron (a French company that manufactures popular homeopathic remedies), Walmart, or Walgreens, but I do like the spirit of the protest, in particular how it drives home a very simply message about homeopathy: There’s nothing in it.

Posted in: Homeopathy

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Of SBM and EBM Redux. Part IV: More Cochrane and a little Bayes

NB: This is a partial posting; I was up all night ‘on-call’ and too tired to continue. I’ll post the rest of the essay later…


This is the fourth and final part of a series-within-a-series* inspired by statistician Steve Simon. Professor Simon had challenged the view, held by several bloggers here at SBM, that Evidence-Based Medicine (EBM) has been mostly inadequate to the task of reaching definitive conclusions about highly implausible medical claims. In Part I, I reiterated a fundamental problem with EBM, reflected in its Levels of Evidence scheme, that although it correctly recognizes basic science and other pre-clinical evidence as insufficient bases for introducing novel treatments into practice, it fails to acknowledge that they are necessary bases. I explained the difference between “plausibility” and “knowing the mechanism.”

I showed, with several examples, that in the EBM lexicon the word “evidence” refers almost exclusively to the results of clinical trials: thus, when faced with equivocal or no clinical trials of some highly implausible claim, EBM practitioners typically declare that there is “not enough evidence” to either accept or reject the claim, and call for more trials—although in many cases there is abundant evidence, other than clinical trials, that conclusively refutes the claim. I rejected Prof. Simon’s assertion that we at SBM want to “give (EBM) a new label,” making the point that we only want it to live up to its current label by considering all the evidence. I doubted Prof. Simon’s contention that “people within EBM (are) working both formally and informally to replace the rigid hierarchy with something that places each research study in context.”

In Part II I responded to the widely held assertion, also held by Prof. Simon, that there is “societal value in testing (highly implausible) therapies that are in wide use.” I made it clear that I don’t oppose simple tests of basic claims, such as the Emily Rosa experiment, but I noted that EBM reviewers, including those employed by the Cochrane Collaboration, typically ignore such tests. I wrote that I oppose large efficacy trials and public funding of such trials. I argued that the popularity gambit has resulted in human subjects being exposed to dangerous and unethical trials, and I quoted language from ethics treatises specifically contradicting the assertion that popularity justifies such trials. Finally, I showed that the alleged popularity of most “CAM” methods—as irrelevant as it may be to the question of human studies ethics—has been greatly exaggerated.


Posted in: Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Medical Academia, Medical Ethics, Science and Medicine

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Complementary and alternative medicine in hospice care

A number of news outlets (e.g. Bloomberg Business Week, MSN.Com, US News, etc) have recently reported that use of complementary and alternative therapies (CAT) is widespread in hospice care facilities. This is based on a report from the Centers for Disease Control, Complementary and Alternative Therapies in Hospice: The National Home and Hospice Care Survey, Untied States, 2007. According to most news reports, about 42% of hospice care providers offer some kind of CAT.

I was initially inclined to find this a little worrisome. In my own field of veterinary medicine, advocates of alternative therapies are prominent among the organizers of the nascent hospice care movement. And while I am strongly supportive of better and more available veterinary hospice care, the involvement of CAM advocates raises the concern that animals at the end of their life might receive ineffective palliative care, or be denied the benefits of conventional treatments by some CAM providers, who often characterize “allopathic” treatments as “unnatural” and harmful.

Posted in: Cancer, Science and Medicine

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Dr. Mehmet Oz completes his journey to the Dark Side

A couple of weeks ago, both Steve Novella and I criticized Dr. Mehmet Oz (a.k.a. “America’s doctor”) for not only hosting a man I consider to be a major supporter of quackery, but going far beyond that to defend and promote him. After that, I considered Dr. Oz to be a lost cause, with nothing to excuse him for his having embraced a man whose website is a wretched hive of scum and quackery almost as wretched as (in my opinion, of course). Unfortunately, apparently Dr. Oz’s defense of Dr. Mercola was only the beginning of the end of whatever minimal credibility Dr. Oz had left as a practitioner of evidence-based medicine.

This week, Dr. Oz put the final nails in the coffin of his credibility as a practitioner of science-based medicine. I realize that some would argue that he did that long ago. Fair enough. However, I always held out some hope that he might stop mixing pseudoscience like reiki with science. Then he embraced Dr. Joseph Mercola. Strike one! Unfortunately, strikes two and three followed over the last week or so.

Posted in: Faith Healing & Spirituality, Religion, Science and the Media

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The Safety Checklist

During my recent stint covering the Neuro ICU I noticed for the first time a checklist posted above each patient bed. The checklist covered the steps to undergo whenever performing an invasive procedure on the patient. I was glad to see that the checklist phenomenon had penetrated my hospital, although the implementation of safety checklists is far from complete.

A recent study published in the BMJ offers support for the efficacy of using checklists to reduce complications and improve patient outcomes. This is a retrospective study looking at mortality and length of stay in Michigan area ICUs, comparing those that had implemented the Michigan Keystone ICU project (including a safety checklist for the placement of central lines) with local ICUs that had not implemented the project. They found a 10% decrease in overall mortality, but the results were not significant for length of stay. Because this was a retrospective study it was not designed to prove cause and effect, but it is highly suggestive of the efficacy of implementing such checklists.

The checklist trend represents a culture change within medicine – and a good one. This change received its greatest boost with the publication of The Checklist Manifesto by Dr. Atul Gawande. He presents a compelling case for the need and efficacy of using checklists in order to minimize error.


Posted in: Public Health, Science and Medicine, Surgical Procedures

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Dr. Paul Offit appears on The Colbert Report

For a touch of the lighter side, here’s Dr. Paul Offit appearing on The Colbert Report to discuss his new book:

Looks like a win to me. I particularly like how Dr. Offit says that the question of whether vaccines cause autism has been “asked and, fortunately, answered.” Heh. That’s a shot across the bow to J.B. Handley, who, as Steve Novella has pointed out (as have I) is utterly clueless about science and how to interpret the medical literature, as he has demonstrated time and time again with his “14 Studies” nonsense. Of course, anyone who calls Handley out on his ignorance is subject to personal attack. Reporters have felt it. Steve Novella has felt his wrath. So have I. Meanwhile Handley gloats over the decline in confidence in vaccines that his organization Generation Rescue has helped foster.

Fortunately, Colbert appears to get it. I like how Colbert does a faux rejection of one of Dr. Offit’s points by pointing out that he is “ruled by fear.” I particularly like how he mentions Andrew Wakefield, but not by name (rather like Lord Voldemort), and how he asks Dr. Offit a bunch of questions based on talking points the anti-vaccine movement likes to use to frighten parents. No wonder the anti-vaccine collective at Age of Autism is going crazy, having posted (and reposted) numerous attacks old and new on Paul Offit ever since it was announced that he was going to be on The Colbert Report last night, all topped off with one by J.B. Handley himself in which he calls Dr. Offit a “blowhard liar.”

Stay classy, J.B. Stay classy.

Posted in: Science and the Media, Vaccines

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