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A temporary reprieve from legislative madness

While doctor visits for influenza-like illnesses seem to be trending downward again, and ”swine flu” is becoming old news, I’d like to draw attention to an H1N1 story that has received very little coverage by the mainstream media.

Doctors in several states can now protect their most vulnerable patients from the H1N1 virus without worrying about breaking the law. In order to save lives, several states have announced emergency waivers of their own inane public health laws, which ban the use of thimerosal-containing vaccines for pregnant women and young children.

Legislators in California, New York, Illinois, Missouri, Iowa, Delaware, and Washington state have enacted these science-ignoring laws in response to pressures from the anti-vaccine lobby and fear-struck constituents. Except for minor differences, each state’s law is essentially the same, so I will focus on the one from my state of New York.

New York State Public Health Law §2112 became effective on July 1, 2008. It prohibits the administration of vaccines containing more than trace amounts of thimerosal to woman who know they are pregnant, and to children under the age of 3. The term “trace amounts” is defined by this law as 0.625 micrograms of mercury per 0.25 mL dose of influenza vaccine for children under 3, or 0.5 micrograms per 0.5 mL dose of all other vaccines for children under 3 and pregnant women. Because thimerosal (and thus, mercury) exists only in multi-dose vials of the influenza vaccines (both seasonal and novel H1N1), this law really only applies to these vaccines. The mercury concentration of the influenza vaccines is 25 micrograms per 0.5 mL, which therefore makes their use illegal. Unfortunately, the only form of the H1N1 vaccine initially distributed, and that could be used for young children and pregnant women, was the thimerosal-containing form. The thimerosal-free vaccine was the last to ship, and in low supply, and the nasal spray is a live-virus vaccine, not approved for use in pregnancy or children under 2. That meant, without a waiver of the thimerosal ban, these groups could not be vaccinated.
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Posted in: Politics and Regulation, Public Health, Science and Medicine, Vaccines

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Naturopaths and the anti-vaccine movement: Hijacking the law in service of pseudoscience

Time and time again, we’ve seen it. When pseudoscientists and quacks can’t persuade the scientific and medical community of the validity of their claims, they go to the law to try to gain the legitimacy that their claims can’t garner through proving themselves by the scientific method. True, purveyors of pseudoscience and unscientifically-derived medical practices do crave the respectability of science. That’s why they try so hard to take on the trappings of science. The problem is that they just can’t do it right, try as they might, or when they do it right their methods are shown to be no more effective than a placebo, aside from the occasional seeming “positive” results that would be expected based on random chance alone. However, failing to achieve the respectability that the mantle of science provides, practitioners and advocates of pseudoscience frequently try to codify their woo into the law.

The reason that they would do this is not too hard to discern. Few legislators and politicians are scientists, and even fewer are scientifically inclined. Back when I still lived in New Jersey, I may have been lucky enough to have had a Congressional Representative who really was a rocket scientist (well, a physicist, actually), but now that I live in Michigan I’ve gone from having a scientifically inclined Congressional representative to having one of the dimmest bulbs in Congress representing me. What that means is that it’s far easier to persuade politicians that this woo or that woo deserves to be permitted or even licensed. That’s how we now have many states licensing acupuncturists, naturopaths, and even “homeopathic physicians,” as Arizona does. The pressure for this sort of acceptance of unscientific medical modalities is building, as well, as Kimball Atwood has documented. Another example is the Dietary Supplement Health and Education Act (DSHEA), which was passed in 1994 and in essence ties the FDA’s hands when it comes to regulating most supplements. Indeed, the very existence of the National Center for Complementary and Alternative Medicine (NCCAM) is a testament to the success of this approach, as a powerful Senator (Tom Harkin, D-IA) almost single-handedly foisted this scientific atrocity on the NIH against the desires of scientists. The results have included a $30 million scientific boondoggle of a trial to test chelation therapy and a profoundly unethical trial of Dr. Nicholas Gonzalez’s “protocol” for pancreatic cancer patients that a recent clinical trial has shown to be worse than useless. The most recent example of this trend is the way that CAM supporters have tried to hijack President Obama’s health insurance reform initiative to insert coverage for everything from any licensed “alternative medicine” practitioner to Christian Science prayer healing.

Recently, two new fronts have been opened up in this battle. One is disturbingly close to me, as it involves the Canadian province of Ontario whose north shore on the Detroit River is less than two and a half miles from my office, the other in Oregon, which, although it’s happening nearly 2,000 miles away from where I live and practice, could portend a new and disturbing tactic of the anti-vaccine movement to do what various other purveyors of pseudoscience have done before and try to win in state legislatures where they can’t win in science or the courts. Of course, in a democratic republic, it is the right of everyone, even supporters of quackery, to try to petition his or her legislators, but it is equally the responsibility of those of us supporting science-based medicine to try to educate legislators why allowing them to alter the law to protect their pseudoscience has the potential to result in great harm.
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Posted in: Herbs & Supplements, Politics and Regulation, Public Health, Vaccines

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Why Universal Hepatitis B Vaccination Isn’t Quite Universal

I am just a parent with some questions about vaccine safety and was happy to find your website.  I have noticed that the Scandinavian countries do not routinely recommend HepB vaccination unless the mother is a known carrier.  I did not see this addressed anywhere on your website and I hope you or one of your colleagues might consider discussing the reasons that some advanced countries are not routinely giving this particular vaccine. Thank you.”

Vaccination is a complicated and at times confusing topic that generates a large number of quite reasonable questions by parents like the one above.  At the same time, the ever-wandering aim of the anti-vaccinationist movement appears once again to be falling on the vaccine against Hepatitis B, and I’ve heard them pose this very question with the intent of sowing doubt in the current vaccination schedule.  Regardless of the source, this question is clearly on the mind of some parents, and I am happy to answer it.

As usual, this question has quite a bit to parse out.  I think it may be most helpful to examine why we vaccinate against Hepatitis B the way we do in the US, how most countries in the world approach the problem, and finally examine the reason why eight European countries do not universally vaccinate against HBV.  First things first though: what is Hepatitis B?

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Posted in: Public Health, Science and Medicine, Vaccines

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The autism “biomed” movement: Uncontrolled and unethical experimentation on autistic children

Ever since I first discovered the anti-vaccine movement, first on Usenet, specifically on a Usenet newsgroup devoted to discussing alternative medicine (misc.health.alternative, or m.h.a. for short) and then later on web and on blogs, there have been two things that have horrified me. First, there are the claims that children suffer all sorts of harm from vaccines, be it being made autistic (with the attendant “autism epidemic” caused by vaccines), suffering neurological damage, immune system damage, and all manner of other adverse consequences. There is no good evidence for these claims (although, as has been documented right here on this very blog time and time again, anti-vaccine activists will trot out all manner of awful studies to support their contentions), but that doesn’t keep useful celebrity idiots like Jenny McCarthy, Jim Carrey, Don Imus, or Bill Maher from repeating the same myths over and over again. Worse, the permeation of society with these myths about vaccines has led to declining vaccination rates and the resurgence of potentially deadly vaccine-preventable diseases. It began first in the U.K. in the wake of Andrew Wakefield’s trial lawyer-funded, incompetent, and possibly fraudulent “research,” and has spread to the U.S., thanks to Jenny McCarthy and her ilk, who won’t take responsibility for their words and actions.

Even worse, the myth that vaccines cause autism has led to ideas. Dangerous ideas, and not because they “challenge” medical orthodoxy. These ideas are dangerous because they have direct consequences for children with autism. These consequences take the form of subjecting children to unscientific treatments that are ineffective at best and harmful at worst, sometimes even life-threatening. Indeed, I have written about case histories in which children were subjected to injections of “stem cells” into their cerebrospinal fluid by lumbar puncture and various other “treatments,” as well as chemical castration in combination with chelation therapy. That latter bit of quackery is something I wrote about years ago, but that the mainstream press only just noticed earlier this year. Better late than never, I guess. Even better than that, though, the same reporting team at the Chicago Tribune that reported on Mark and David Geier’s advocacy of Lupron to treat autistic children back in May. Sadly, the result of that story does not appear to have been actions by the State of Maryland to take away Dr. Mark Geier’s medical license or to go after his son David for practicing without a license. Neither does it appear to have resulted in insurance companies going after them for prescribing an expensive drug for an indication for which it is not appropriate. What it does appear to have done, however, is to inspire the same journalist, Trine Tsouderos, along with another journalist from the Chicago Tribune, Patricia Callahan, to pursue an even bigger target that Mark and David Geier, namely the entire “autism biomed movement,” which is for the most part rank quackery, in the following articles:

This is another rare case of excellent reporting on this issue, and I hope that this report (another installment of which was published early this morning after I had written this post) will grab the attention of more reporters and news outlets, leading to shining a light on the dark underbelly of the autism biomed movement.
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Posted in: Health Fraud, Herbs & Supplements, Public Health, Vaccines

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Conflicts of interest in science-based medicine

The topic of conflicts of interest among medical researchers has recently bubbled up to the public consciousness more than usual. The catalyst for this most recent round of criticism by the press and navel-gazing by researchers is the investigation of Senator Charles Grassley (R-IA) of nine psychiatric researchers, one of which held $6 million in stock in a company formed to bring a drug for depression to market, but had allegedly concealed this, even though he was an investigator on an NIH grant to study the drug he was developing. From my perspective, there is more than a little politics going on in this story, given that for the last decade federal law, specifically the Bayh-Dole Act, and policy have actually encouraged investigators and universities to co-develop drugs and treatments with industry, but it does bring into focus the issue of conflicts of interest, in particular undisclosed conflicts of interest. There are two articles of note that recently appeared in the scientific literature discussing this issue, one in Science in July (about the Grassley investigation) and an editorial in the Journal of Psychiatry and Neuroscience by Simon N. Young, PhD, the Co-Editor-in-Chief of the journal and faculty at McGill University. I was more interested in the latter article because it takes a much braoder view of the issue. Science-based medicine (SBM) depends upon the integrity of the science being done to justify treatments; so it’s useful to discuss how conflicts of interest intersect medical research.

In most public discussions of conflicts of interest (COIs), Young notes, the primary focus is on payments by pharmaceutical companies to investigators. Make no mistake, this is a big issue, but COIs are not just payments from drug companies. Indeed, I’ve written about just such COIs that have arguably impacted patient care negatively right her on this very blog, for example seeding trials (in which clinical trials are designed by the marketing division of pharmaceutical companies), a case of fraud that appeared to have been motivated by COIs. What needs to be understood is that every single scientific and medical investigators have COIs of one sort or another, and many are not financial. That’s why I like Young’s introduction to what COIs are:
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Posted in: Clinical Trials, Medical Academia, Politics and Regulation, Vaccines

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Pseudo-expertise versus science-based medicine

I am a skeptic.

My support for science-based medicine, as important as it is and as much time, sweat, and treasure I spend supporting it, is not the be-all and end-all of my skepticism, which derives from a scientific world view. That’s why, every so often, I like to step back from medicine a bit and look at the broader picture. It’s a good idea to do this from time to time, because to me, many of the topics that I and my fellow SBM bloggers write about are not just manifestations of anti-science and pseudoscience in medicine, but rather of a broader problem of anti-science and pseudoscience in society at large. I concentrate on medicine because it’s what I do and because manifestations of pseudoscience in medicine have the potential to harm or even kill large numbers of people.

Look no further than the anti-vaccine movement if you don’t believe me. Already, a mere decade after Andrew Wakefield’s lawyer-funded, incompetent, and perhaps even fraudulent “study” about a supposed relationship between the MMR vaccine and autism, uptake of MMR vaccines have plummeted throughout the U.K., with some areas of London reporting only 50% uptake, far too low for effective herd immunity. Thanks to J.B. Handley, Jenny McCarthy, Jim Carrey, and the know-nothing band of celebrities and activists, we are in serious danger of having the same sort of thing happen right here in the U.S. Indeed, Jenny McCarthy herself has even acknowledged that, although in her characteristically self-absorbed and vulgar manner, she refused to take responsibility for her part in this impending public health debacle, dismissing her role by saying, “I do believe sadly it’s going to take some diseases coming back to realize that we need to change and develop vaccines that are safe. If the vaccine companies are not listening to us, it’s their fucking fault that the diseases are coming back. They’re making a product that’s shit. If you give us a safe vaccine, we’ll use it. It shouldn’t be polio versus autism.” Meanwhile autistic children suffer from the quackery to which they are subjected in a futile attempt to “recover” them from “vaccine injury”-induced autism.

But it’s not just the anti-vaccine movement. It’s cancer quackery, promoted by “luminaries” such as Suzanne Somers and Bill Maher, given aid and comfort by doctors gone bad such as Dr. Rashid Buttar and Dr. Nicholas Gonzalez, “bioidentical hormone” woo promoted by the aforementioned Suzanne Somers and Dr. Christiane Northrup. It’s all manner of other faith-based and definitely non-science-based medicine so called “complementary and alternative medicine” (CAM, which is neither complementary nor medicine, although there is no doubt that it’s “alternative”) or “integrative medicine” (which “integrates” pseudoscience with effective medicine to the detriment of patients) finding its way into our academic medical schools, even to the point of being mandatory at at least one medical school and being a strongly touted option at many others. Meanwhile, the misbegotten behemoth of woo, funded by your tax dollars and mine, the National Center for Complementary and Alternative Medicine (NCCAM) promotes remedies based on a prescientific understanding of how the body works and what causes diseases, even going so far as to promote “integrative medicine” residencies. Meanwhile science-based medical students face a serious dilemma: Go with the flow or fight.
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Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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Yes, But. The Annotated Atlantic.

Reposted on 11/8 with multiple typo corrections.

The Atlantic recently published an article called “Does the Vaccine Matter?.” The quick answer is “yes”. If you want to know more, keep reading. They concluded, based on a narrow interpretation of a small subset of the data, that vaccines probably do not matter. The tone suggests that the vaccine is a vast boondoggle perpetuated on the American people by frightened doctors and greedy pharmaceutical companies. At least that is my take on the article, your mileage may vary. Lets look at that article, and its review of the influenza vaccine, and see whatthe authors  say, how they say it, and, perhaps more importantly, what they don’t say.

Unfortunately, I do not have a good story to tell with protagonists and antagonists and lone voices protesting the evil medical industrial complex. I don’t have a morality tale to tell, with good guys and bad guys. I have the medical literature, with its numbers and uncertainties and nuance. I also have patients I have to treat and have to apply the medical literature to as best I can.
This entry may be a bit of a repetition for those who read my previous entry on vaccine efficacy, but my entry hit the blogosphere a few days before the Atlantic article, so I did not get a chance to incorporate it into my entry. (more…)

Posted in: Science and the Media, Vaccines

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J.B. Handley of the anti-vaccine group Generation Rescue: Misogynistic attacks on journalists who champion science

There’s been something I’ve been meaning to write about all week, but only just got around to it. There were lots of other things going on at my other online locale, and this topic is such old hat for so many that I really wasn’t sure if it was worth bothering with. My reluctance may also be, sadly, because I’ve become a bit jaded at the nastiness that anti-vaccine groups such as Generation Rescue (i.e., “Jenny McCarthy and Jim Carrey’s Autism Organization”–at least these days) and its erstwile founder J.B. Handley routinely lay down when someone points out that the emperor has no clothes, that vaccines do not cause autism. I’m referring, of course, to Amy Wallace, who wrote what is the best example of an article in the mainstream media about the anti-vaccine movement that “gets it.” The article was called An Epidemic of Fear: How Panicked Parents Skipping Shots Endangers Us All and appeared in WIRED Magazine.

It was a thing of beauty. There was no false “balance” that puts cranks pushing dangerous pseudoscience on the same plane as real scientists like Paul Offit. There was even a section calling out purveyors of vaccine misinformation. Several luminaries of the the anti-vaccine movement were there, including ones discussed frequently on this blog, like Jenny McCarthy and Jim Carrey, and Robert F. Kennedy, Jr. But that wasn’t all! There was even a section on how to debunk anti-vaccine canards. What more could an advocate of science-based medicine ask for?
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Posted in: Science and the Media, Vaccines

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The effective wordsmithing of Amy Wallace

One of the most engaging and clearly-written pieces of science journalism over the last year or so was published in Wired magazine last week. Now in the midst of a firestorm of attention, Amy Wallace’s, “An Epidemic of Fear: How Panicked Parents Skipping Shots Endangers Us All,” is part interview with rotavirus vaccine developer, pediatric infectious disease physician and immunologist, Dr Paul Offit, and description of the anti-vaccination movement in the United States.

Wallace’s work is the centerpiece of a masterful collection of smaller articles providing science-based information about vaccination that also refuts common anti-vaccination myths including “How To Win An Argument About Vaccines” and “The Misinformants: Prominent Voices in the Anti-Vaccine Crusade”.

Wired’s follow-up discussion of the issue includes, “A Short History of Vaccine Panic,” for those of us who “have a day job” and not enough time to read Paul Offit’s 2008 book, “Autism’s False Prophets.”
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Posted in: Public Health, Science and the Media, Vaccines

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A Not-So-Split Decision

For those who battle tirelessly against the never ending onslaught of anti-vaccine propaganda, misinformation, and fear, there was great news the other day from Merck. The pharmaceutical company, and maker of the MMR vaccine against measles, mumps, and rubella, has decided not to resume production of the individual, or “split”, components of the vaccine. A Merck representative made the announcement during a meeting of the CDC Advisory Committee on Immunization Practices (ACIP) on Tuesday. During previous ACIP meetings, science experts on that committee presented compelling arguments against  continued, large scale production of the monovalent components of the MMR vaccine, which were echoed by scientists in Merck’s vaccine division. In a moment, I’ll discuss the arguments against the split vaccine, and why this is so important a decision. First, some background on the issue of splitting the MMR.
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Posted in: Science and Medicine, Vaccines

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