Science-Based Medicine

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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We’ve written a lot about anti-vaccine zealotry on this blog, as Steve and I take a particular interest in this particular form of dangerous pseudoscience for a number of reasons. One reason, of course, is that the activities of antivaccine groups like Generation Rescue and its spokesmodel since 2007 (Jenny McCarthy, a frequent topic on this blog) have started to frighten parents about vaccines enough that vaccination rates are falling well below that required for herd immunity in some parts of the country. Indeed, McCarthy, at the behest of her handlers in Generation Rescue, serves up a regular “toxic” brew of misinformation and nonsense about vaccines, most recently in a video that was the subject of a post by Val Jones about her unbelievably pseudoscience-laden blather. Truly, it has to be seen to be believed. Meanwhile, Generation Rescue has sent McCarthy on a media propaganda tour for her latest antivaccine pro-quackery book and set up a misinformation-laden propaganda site called Fourteen Studies (blogged about by Steve Novella, Mark Crislip, and, of course, yours truly) in which they attack well-designed studies that have failed to confirm their pet idea that somehow, some way, vaccines must be the cause of autism. And, when their pseudoscience is criticized, the antivaccine movement has a tendency to launch vicious ad hominem attacks, as they recently did against Steve Novella and have done multiple times in the past against me.

However, there is one other consequence of the antivaccine movement, however, and it is at least as important as the public health implications of the potential dimunition of herd immunity caused by the fear mongering of groups like Generation Rescue. That consequence is the cottage industry of “biomedical” treatments to which desperate parents subject their children. Gluten-free diets, chelation therapy (which has caused deaths), hyperbaric oxygen chambers (a recent story described a child getting severely burned when one of these caught fire), autistic children have been subjected to it all. But of all the biomedical woo to which autistic children have been subjected, one form of woo stands out as being particularly heinous. Indeed, I agree with our fearless leader Steve in characterizing it as an “atrocity.”

I’m referring to Mark and David Geier’s favored “treatment” for autistic children, namely a drug called Lupron.
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Several people have been sending me either links to this paper or even the paper itself:

Young HA, Geier DA, Geier MR. (2008). Thimerosal exposure in infants and neurodevelopmental disorders: An assessment of computerized medical records in the Vaccine Safety Datalink. J Neurol Sci. 2008 May 14 [Epub ahead of print]. (Full text here.)

A few have asked me whether I was planning on deconstructing this study, given that antivaccinationists have apparently been promoting it as “evidence” that it really, truly, and honestly was the mercury in vaccines after all that caused autism. In actuality, I really didn’t feel the need to bother to do a full deconstruction because a new blogger called EpiWonk did a three part take-down that eviscerated this latest bit of “science” from Geier père et fils so thoroughly and with a much greater knowledge of epidemiology than I could ever muster, that I saw no need. Add to that a four-part takedown on the Pathophilia blog, and there was really no need for me to write a detailed deconstruction of my own. Unfortunately, since this study appears to be rearing its ugly head again and again in the blogosphere, I think it’s worth directing you to these discussions. I had been meaning to to this anyway, but had gotten side-tracked by numerous other topics. To make up for my lapse, here we go:

1. New Study on Thimerosal and Neurodevelopmental Disorders: I. Scientific Fraud or Just Playing with Data?
2. New Study on Thimerosal and Neurodevelopmental Disorders: II. What Happened to Control for Confounding?
3. New Study on Thimerosal and Neurodevelopmental Disorders: III. Group-Level Units of Analysis and the Ecological Fallacy

Meanwhile, the Pathophilia blog also has a multi-part deconstruction of the latest Geier study from a different viewpoint:

1. IRB Approval of Geier Autism Study: Yes or No?
2. I’ve Been Sucked Into the Thimerosal-Autism-Geier Vortex
3. Young-Geier Autism Study: What the—? (Part 1)
4. Young-Geier Autism Study: What the—? (Part 2)
5. Young-Geier Autism Study: What the—? (Part 3)
6. Young-Geier Autism Study: What the—? (Part 4)

Ow! That’s gonna leave a mark!
Enjoy! And the next time an antivaccinationist points to this particular study, send ‘em over to see EpiWonk and Pathophilia.

One of the most pernicious medical myths of recent years has been the claim, promulgated by a subgroup of parents of autistic children and facilitated by scientists of dubious repute, that somehow the mercury in the thimerosal (ethyl mercury) preservative used in common childhood vaccines in the U.S. until early 2002 causes autism. Although it had been percolating under the radar of most parents and scientists for several years before, this belief invaded the national zeitgeist in a big way in 2005, beginning with the publication of a book by journalist David Kirby entitled Evidence of Harm: Mercury in Vaccines and the Autism Epidemic: A Medical Controversy. The fires of hysteria were stoked even higher by Robert F. Kennedy, Jr., who published a truly twisted and misleading piece of pseudojournalism and pseudoscience published simultaneously in Rolling Stone and on Salon.com entitled Deadly Immunity. Relying primarily on quote-mining of the transcripts of both a conference held Atlanta by the CDC to discuss the question of whether autism is related to thimerosal in vaccines and an Institute of Medicine report on vaccines while simultaneously misrepresenting the results of two studies by Verstaeten et al to paint a false picture of a government coverup, RFK Jr. almost single-handedly managed to stoke fears that vaccines were causing an “epidemic of autism.”

I say “almost” single-handedly, because, unfortunately, he had help. Relying on the dubious research of a variety of investigators, such as the father-and-son team of Dr. Mark Geier and David Geier, whose prodigious output of badly designed studies emanating from a lab in their home in suburban Maryland, done using a rubberstamp institutional review board stacked with friends and cronies to approve the studies, and published for the most part in non-peer-reviewed journals, activists loudly insisted that mercury in vaccines was the cause of most autism. Others claiming to demonstrate this link include Boyd Haley, a chemist from the University of Kentucky, and a few other vocal scientists and advocates, who claim that autism is, in essence, mercury poisoning. Facilitating the dissemination of this message were reporters such as David Kirby, activists such as Robert F. Kennedy, Jr., and media personalities such as Don Imus. Indeed, some activists claimed that some vaccines were “poisoning” our children, even going so far as show photos of autistic children with the label “mercury-poisoned“ underneath them on placards held aloft at protest rallies. They made quite a splash then, and still do to a lesser extent even today. There’s just one problem.
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I approach this week’s topic with a bit of trepidation, even though I’ve been meaning to discuss it ever since this blog started. Over the weekend, I decided I had put it off long enough.

Why, you might ask, would I approach this topic with trepidation? A reasonable question, and I will give what I hope to be a reasonable answer. For one thing, this topic forces me to drift to areas more political than I normally like and is likely to provoke some angry reactions. More importantly, though, I’m about to discuss a medical organization that is steeped in an utterly toxic brew of bad science and extreme ideology. So what? you might ask. Well, there are some fairly prominent physicians that belong to this organization, including Ron Paul, among others, and you never know who in my own place of employment or referral base might also belong. For all I know, one of my bosses might belong. I sincerely hope this isn’t the case (or if it is they just don’t know about the organization’s extreme views), but you never know, and what I’m about to write is going to be harsh indeed because articles from the journal published by this organization are often cited by cranks and pseudoscientists. Sometimes they even make their way into the mainstream press as though they were legitimate scientific studies. Make no mistake, though, when it comes to medical science, this organization deserves every harsh word that I am about to write because it is a major booster of antivaccinationism, HIV/AIDS denialism, and the now discredited hypothesis that abortion causes breast cancer, while on its pages it regularly attacks the very concept of evidence-based medicine and peer-review. That it is an organization of physicians is all the more appalling.

The group to which I refer is the Association of American Physicians and Surgeons (AAPS), and its journal is the Journal of American Physicians and Surgeons (abbreviated JPANDS, because “JAPS” has some rather obvious negative connotations). It is not an exaggeration to say that the AAPS, through its journal JPANDS, is waging a war on science- and evidence-based medicine in the name of its politics.
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One of the hallmarks of science as it has been practiced for the last century or so is that scientists share their discoveries in the peer-reviewed literature, where their fellow scientists can evaluate them, decide if they’re interesting, and then replicate them, usually as a prelude to building upon them. While the system of publication and peer review in science is anything but perfect (and, indeed, we have discussed many of its shortcomings right here on this very blog), I tend to like to view it in much the same way Winston Churchill characterized democracy:

Many forms of Government have been tried and will be tried in this world of sin and woe. No one pretends that democracy is perfect or all-wise. Indeed, it has been said that democracy is the worst form of government except all those other forms that have been tried from time to time.

I would rephrase this as:

Many forms of evaluating science have been tried and will be tried in this world of sin and woe. No one pretends that peer review is perfect or all-wise. Indeed, it has been said (by me) that peer review is the worst form of evaluating science except all those other forms that have been tried from time to time.

As mainstream medicine has become more scientific over the last century in the wake of the Flexner Report, physicians and medical researchers have similarly come to view publication in the peer-reviewed literature to be a very important component of communicating and evaluating medical discoveries. It’s not as though this is even a particularly high bar to pass, either. After all, many are the absolutely execrable papers that I (and my partners in crime here at SBM) have discussed over the last four years, nearly all of which were in peer-reviewed journals, some very prestigious. After all, if papers on “energy chelation” can find their way into decent journals and the likes of Mark and David Geier can publish in the peer-reviewed literature, while someone like Christopher Shaw can get cringe-worthy confusions of correlation with causation published, I don’t take seriously the whines of cranks who claim that they can’t publish in the peer-reviewed literature for one reason or another.

That’s why I view being published in the peer-reviewed literature as a minimum, but by no means sufficient, requirement good science. It’s also why, whenever I see a new claim, my first reaction is to see if (1) the person making the claim has published on it and (2) there are publications in the peer reviewed literature that support the claim. The first criterion helps me judge whether the person is a serious scientist; the second, whether there is any plausibility to his ideas. Sure, it’s not a foolproof scheme, but it is helpful.

I only wish antivaccinationists would do the same. That they don’t explains why they seem to be embracing someone named Dr. Hanan Polansky.
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I hadn’t planned on writing about the antivaccine movement again this week, so soon after having had to subject myself to yet another round of Jenny McCarthy on Larry King Live and a truly execrable Generation Rescue “study.” I really hadn’t. For one thing, there’s just so much nonsense laid down by antivaccinationists these days that it’s utterly impossible for one blogger to keep up with it all. I could write about them every single day and still not counter the sheer mass of pseudoscience, misinformation, and general ignorance that antivaccine activists spout each and every day, and because this is Autism Awareness Month lately the misinformation has been coming particularly fast and furiously. Sometimes, however, there arrives a bit of misinformation that is so egregious that it requires some response, regardless of how burned out on the topic I might be; so I guess I’ll just have to suck it up and plunge into the morass again.

The reason is that, in retrospect, I now realize that the Jenny and Jim antivaccine propaganda tour was clearly merely phase I of Generation Rescue’s April public relations offensive. In rapid succession last week, courtesy of J.B. Handley, the founder of Generation Rescue, who in order to have a couple of famous faces fronting his organization has allowed himself to be displaced, so that Generation Rescue has now been “reborn” as Jenny McCarthy and Jim Carrey’s Autism Organization (the better to capitalize on her D-list celebrity yoked to Jim Carrey’s formerly A-list (but rapidly plunging) celebrity), announced Generation Rescue’s latest initiative in a post on its antivaccine blog Age of Autism entitled Fourteen Studies? Only if you never read them.:
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As a physician and scientists who’s dedicated his life to the application of science to the development of better medical treatments, I’ve often wondered how formerly admired scientists and physicians fall into pseudoscience or even generate into out-and-out cranks. Examples are numerous and depressing to contemplate. For example, there’s Linus Pauling, a highly respected chemist and Nobel Laureate, who in his later years became convinced that high dose vitamin C could cure cancer. Indeed, Pauling’s belief that high dose vitamin C could cure the common cold and cancer fueled the development of a whole new form of quackery known as “orthomolecular medicine,” whose entire philosophy seems to be based on the concept that if some vitamins are good more must be better. In essence, “orthomolecular medicine” is a parody of nutritional science; indeed, its advocates take credit for how some strains of “complementary and alternative medicine” (CAM) so frequently advocate the ingestion of huge amounts of dietary “supplements.” I could even go farther and say that orthomolecular medicine is clearly a major part of the “intellectual” (and I do use that term loosely) underpinning of the various biomedical treatments for autism that Jenny McCarthy and Generation Rescue advcoate.

There are other examples as well, all just as depressing to contemplate. For example, consider Peter Duesberg, a brilliant virologist who in the 1980s was widely believed to be on track for a Nobel Prize; that is, until he became fixated on the idea that HIV does not cause AIDS. True, lately he’s been trying to resurrect his scientific reputation with his interesting and possibly even promising chromosomal aneuploidy hypothesis of cancer, but, alas, true to form he’s been doing it by acting like a crank. Specifically, he sees his hypothesis as The One True Cause of Cancer and disparages conventional thinking as having been so very, very wrong all these years (with his being, of course, so very, very brilliant that he saw what no one else could see). Then there are people like Dr. Lorraine Day, who was a respected academic orthopedic surgeon in the 1980s. In the late 1980s, she started to flirt with AIDS pseudoscience through a scare campaign about catching AIDS from aerosolized blood. Of course, given the mystery and fear over HIV in the early years of the epidemic, such a fear, although overblown, was not so far out of the mainstream as to be worthy of the appellation crank. However, after being diagnosed with breast cancer, unfortunately Dr. Day rapidly degenerated into a purveyor of rank pseudoscience, as well as a New World Order conspiracy theorist, religious loon, and Holocaust denier. And let’s not forget Mark Geier, who, although not a distinguished scientist, did, before his conversion to antivaccinationism, apparently do a real fellowship at the NIH and appeared to be on track to a respectable, maybe even impressive, career as an academic physician. Now he’s doing “research” in his basement, injecting autistic children with a powerful anti-sex hormone drug and abusing epidemiology. There are innumerable other examples.
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One of the most contentious and difficult aspects of trying to improve medical care in this country is enforcing a minimal “standard of care.” Optimally, this standard of care should be based on science- and evidence-based medicine and act swiftly when a practitioner practices medicine that doesn’t meet even a minimal requirement for scientific studies and clinical trials to support it. At the same time, going too far in the other direction risks stifling innovation and the ability to individualize treatments to a patient’s unique situation–or even to use treatments that have only scientific plausibility going for them as a last-ditch effort to help a patient. Also, areas of medicine that are still unsettled and controversial could be especially difficult to adjudicate. Unfortunately, with medicine being regulated at the state level, there are 50 state medical boards, each with different laws governing licensure requirements and standards for disciplining wayward physicians, our current system doesn’t even do a very good job of protecting the public from physicians who practice obvious quackery. The reasons are myriad. Most medical boards are overburdened and underfunded. Consequently, until complaints are made and there is actual evidence of patient harm, they are often slow to act. Also, in my experience, they tend to prefer to go after physicians who misbehave in particularly egregious ways: alcoholic physicians or physicians suffering from other forms of substance abuse; physicians who sexually abuse patients; or physicians who are “prescription mills” for narcotics. These sorts of cases are often much more clear-cut, but most importantly they don’t force boards to make value judgments on the competence and practice of physicians to nearly the extent that prosecuting purveyors of unscientific medicine does.

Dr. Rashid Buttar: Autism and cancer

The reason I’ve been thinking about this issue again is because last Friday it was announced that one of the most dubious of dubious physicians of which I have ever become aware, Dr. Rashid Buttar of North Carolina, was, after many years of practice, finally disciplined by the North Carolina Board of Medical Examiners. Basically, the Board restricted his practice so that he could no longer treat children or cancer patients (more on why those two particular restrictions were imposed below). Once hailed as a hero by antivaccinationists and even once having testified to the Subcommittee on Wellness & Human Rights on autism issues, he is now disgraced.

Dr. Buttar runs a clinic called the Center for Advanced Medicine and Clinical Research, which features on its front page this quote:

“All truth passes through 3 phases: First, it is ridiculed. Second, it is violently opposed, and Third, it is accepted as self-evident.”- Arthur Schopenhauer, 1788-1860.

I can’t resist mentioning that any time I see this particular quote, I know that I’m almost certainly dealing with someone who is far on the fringe, because what one first has to realize about the quote is that non-”truth” never makes it past phase one or two–and rightly so. Right off the bat, we can see that Dr. Buttar has a greatly inflated view of his own importance.
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Introduction: The following is the text of a letter that I mailed to Bob Sliva, General Manager of WXYZ-TV in Detroit in response to arguably the most biased and incompetent “investigative report” about mercury, vaccines, or autism that I have ever seen. I sent the letter by snail mail, because I was always taught that that gets a station manager’s attention far better than e-mail. My plan was to allow the three days until today for the letter to arrive and then to publish the text of my letter here on SBM as an open letter. After I mailed my letter, I worried that no one would bother to look at links that they had to type in themselves, which is why I wanted to post this as an open letter whose link I could then e-mail to the station.

I also worried that maybe I had been insufficiently polite and persuasive, given that one is always urged not to be too insulting or strident when writing to a media outlet. After all, if I were too strident, Mr. Sliva would find it easy to write me off as a biased crank. I also worried that maybe I should have e-mailed Mr. Wilson first. On the other hand, Mr. Wilson is a serial offender. In 2003 and 2004, he did a series on mercury, vaccines, and autism that credulously parroted all the pseudoscience, distortions, and misinformation that we’ve come to expect from the anti-vaccine movement. About two weeks before the “Green Our Vaccines” rally, my routine monitoring of the anti-vaccine underground turned up references to a story that Wilson was working on about the rally and the thimerosal issue. Believers in the myth that vaccines cause autism described Wilson and his earlier report in glowing terms, which sent up huge red flags to me. The original links no longer function, but, thanks to the Wayback Machine, I was able to find the transcripts of the original reports (1, 2, 3, 4, 5). This “reporting” (if you can call it that) somehow garnered an Emmy Award, showing that an award, even a normally prestigious one, is no guarantee of anything resembling scientific accuracy in reporting.

However, it was Mr. Wilson’s comments and behavior after a post by a friend of mine, Dr. Peter Lipson, that made me realize that dealing directly with Wilson was a waste of time and that I was right to go straight to the General Manager. I’ll show why in an addendum and will also add references to sources that refute Wilson’s one-sided and credulous reporting. It’s funny how such a pit pull of an “investigative journalist” who goes after politicians and others with such tenacity can’t find it in himself to ask even a mildly probing question when interviewing “luminaries” such as Boyd Haley or parents with no scientific background repeating anti-vaccine talking points. In any case, here follows the text of the letter that I sent to Bob Sliva, the Vice President and General Manager of WXYZ-TV:

July 9,2008Bob Sliva
Vice President/General Manager
WXYZ-TV
20777 West Ten Mile Road
Southfield, MI 48037

Dear Mr. Silva:
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