The anti-vaccine “biomed” movement: Hijacking legitimate scientific research

As hard as I find it to believe, the fifth anniversary of this blog is fast approaching. When I started this whole endeavor, it was more or less on a whim that struck me on a cold, dreary, gray Saturday in December, and I had no idea that five years later I’d still be at it, much less that I’d have this many readers. One thing that trying to apply a skeptical and scientific world view to various pseudoscience has allowed me to do, more than just the occasional fit of depression at looking at pseudoscience now, comparing it to pseudoscience then and back in my Usenet days in the late 1990s and early 2000s, and realizing that teh well of stupid is deep and unyielding indeed, is to see patterns that I didn’t see before, at least not easily. I don’t claim in any way that I’m making what are necessarily original observations; many skeptics have made them before. But there’s a difference between being told these observations and actually seeing them for yourself.

Another thing I’ve been examining over the last five years, ever since I first discovered it, is a relatively few patterns, which is why I almost feel ashamed that I can’t recall ever having explicitly about what Trine Tsouderos and Patricia Callahan at the Chicago Tribune have written as a followup to their excellent expose on the autism “biomed” (i.e., anti-vaccine quackery) movement. I’m sure I’ve alluded to it before, but I don’t think I put it in quite the same terms in one place. Specifically, it’s about how the autism biomed movement abuses existing legitimate scientific studies to justify its quackery. As Tsouderos and Callahan put it, it’s Autism treatment: Science hijacked to support alternative therapies.

That’s exactly what it is.

The story starts out giving a particularly egregious example:

Dr. Carlos Pardo was trying to head off trouble.

The Johns Hopkins neurologist and his colleagues had autopsied the brains of people with autism who died in accidents and found evidence of neuroinflammation. This rare look inside the autistic brain had the potential to increase understanding of the mysterious disorder.

It also, he knew, could inspire doctors aiming to help children recover from autism to develop new experimental treatments — even though the research was so preliminary the scientists did not know whether the inflammation was good or bad, or even how it might relate to autism.

So when Pardo and his colleagues published their paper in the Annals of Neurology in 2005, they added an online primer that clearly explained their findings in layman’s terms and sternly warned doctors not to use them to develop treatments.

“We were concerned that the study would raise a lot of controversy and be misused,” Pardo said. “We were right.”

Over and over, doctors in the autism recovery movement have used the paper to justify experimental treatments aimed at reducing neuroinflammation.

This is not at all a suprise to those of us who have been following the autism quackery movement over the last few years. If there’s a group that’s better at taking legitimate scientific studies and extrapolating from them far beyond what reason, science, medicine, or ethics would ever allow or even what the scientists doing the research could imagine in their worst nightmares, it’s the autism anti-vaccine quackery movement. Indeed, whole organizations, including Generation Rescue and the Autism Research Institute appear to devote huge amounts of effort to cherry picking legitimate scientific studies and using them to justify unproven treatments, many of which are in my estimation (and that of many other physicians and scientists) rank quackery.

I think part of the explanation comes from an extreme disconnect between what real clinician-scientists view as a scientific basis:

Physicians and others in the movement — many affiliated with the organization Defeat Autism Now! — say their treatment protocols rest on a foundation of solid science

And, yes, we frequently hear this from supporters of autism “biomed,” that they’re really scientists, maaaaan! Science. They keep using that word. I do not think it means what they think it means. (Sorry about that, but I couldn’t resist.) Basically, what these DAN! doctors do is to fixate on a single interesting observation that may or may not be widely accepted in the scientific community yet and then devise what they perceive to be interventions based on these observations. That “neuroinflammation” has something to do with autism is perhaps the most prevalent such observation, and many are the woo-ful interventions, including intravenous immunoglobulin, hyperbaric oxygen, and a drug designed to treat a rare genetic disease. There’s no good evidence that any of them work.

The most blatant example of hijacking legitimate science to justify quackery comes from the father-son team of autism “researchers” who operate out of the basement of the father’s Silver Spring, MD home. I’m referring, of course, to Mark and David Geier, the originators of the “Lupron protocol,” which I first wrote about over three years ago and Tsouderos reported on earlier this year. This protocol was based, in part but by no means all, on the work of world-renowned autism researcher Simon Baron-Cohen. He’s the originator of the concept that autism is a result of an “extreme male brain” involving abnormal levels of testosterone during fetal development. Of course, the Geiers took the concept that elevated levels of testosterone might have something to do with autism and flew right into the woo-osphere with it, postulating that testosterone forms “testosterone sheets” that bind to mercury and that lowering testosterone levels in autistic children with powerful drugs like Lupron allows chelation therapy to work better. Never mind that on a stictly chemical level this entire idea is poppycock, with no support for it whatsoever.

Another area of science that the “biomeddlers” like to hijack wasn’t mentioned in the story. Specifically, it’s a variety of studies that suggest differences in glutathione metabolism and methylation in the brains of people with autism. Specifically, it’s been postulated but not well demonstrated that autistic children may make less glutathione. In a perfect case of crank magnetism, because glutathione is involved in mercury detoxification, anti-vaccinationists further postulate that low levels of glutathione in autistic children somehow make them more susceptible to “mercury” toxicity from the thimerosal in vaccines. Sounds nice, neat, and plausible, right? Wrong. For one thing, what was shown was that autistic children may have 33% less of the reduced form of glutathione and nothing about overall glutathione levels being different. It’s based on a flawed understanding of physiology and, like the very idea that the tiny amount of mercury that used to be in vaccines is sufficient to cause neurologic changes consistent with autism, implausible when you look at it more carefully, as Not Mercury described nearly four years ago:

If the average human carries around approximately 6 milligrams of mercury how much glutathione should we require to deal with environmental mercury levels ? Even if several molecules of glutathione were required for each mercury molecule, we should have millions of times sufficient glutathione to get the job done. Compare that to the reported upper limit of exposure through vaccines which has been estimated at less than 250 micrograms. A person so severely deficient in glutathione they would be unable to detoxify 250 micrograms of mercury probably wouldn’t survive long enough to be vaccinated in the first place. Every breath of air would expose them to lethal levels of ozone, pollutants and other oxidants.

Yet that doesn’t stop the “biomeddlers” from prescribing all sorts of “anti-oxidant” and “detoxification” cocktails containing glutathione and or its amino acid precursors, cysteine and glycine, to autistic children to “treat” their nonexistent thimerosal toxicity and/or “heavy metal” toxicity. Basically, once the anti-vaccine movement gets a hold of science, their application of it is related to the original research by coincidence only. Well, coincidence twisted by their over-arching belief that autism is due to vaccines and and “toxins.” This results in subjecting autistic children to pain for no gain:

  1. We tried Oral Glutathione; it resulted in a tremendous yeast outbreak. We also found studies that glutathione supplementation did not survive the digestive process to yield results.
  2. We tried Topical Glutathione; it caused a bad rash and undesired behaviors (this is an understatement!). At the time, there was only a soy-based topical glutathione Рtoday you can acquire cr̬me without soy or other allergens.
  3. We tried an initial dose of IV Glutathione: 250 mg (really an IV Push; 5-10 minutes)
    a. Some hints: We brought a portable DVD Player along, and prepared his arm with a big glob of EMLA cream prior to infusions. At the time, Jeff was 5 years old and around 40 lbs. The first treatment was in Fall 2002.
  4. Another type of glutathione administration is through a nebulizer.

None of this means that they can’t produce a whole bunch of science-y appearing studies in seeming support of their ideas, as both Kent Heckenlively and Terri Arranga tried to do in response to the Trib story, to hilariously misguided effect. Many of them can even draw convincing looking charts showing glutathione metabolism and make all sorts of hand-waving, science-y proclamations about how autistic children are have higher “oxidative stress.” It all sounds very, very plausible to people who are not biochemists. Again, however, it’s extrapolating preliminary data straight into woo land. As has been documented here and elsewhere time and time again, these studies virtually always fall into one of three categories. Either their findings are not related to the treatment claims made by the biomed movement (or only tangentially related), or, alternatively, they are so far in the realm of basic science that, even if the results pan out, they are years, if not decades, from potential clinical use, if they ever demonstrate clinical applicability at all. Finally, the third category of studies cited by the biomed movement are studies done by its members. These are virtually all of very poor quality, often lacking proper controls, or of inadequate power to tell us much of anything. Sometimes, like homeopathy studies, they appear to be “positive” studies of highly implausible hypotheses due to random chance. Worse, there is an intense hypocrisy in these studies. Investigators with massive conflicts of interest, like Andrew Wakefield, can have their “studies” funded by lawyers looking to sue vaccine manufacturers and the biomed movement sees nothing wrong with that. Yet this same movement dismisses any study in which even a single investigator has ever been funded by a pharmaceutical company, sometimes going to truly ridiculous extremes to do so.

In this, the autism “biomed” movement is very much of a piece with crank and pseudoscience movements of all kinds, be they creationists, believers in “alternative” medicine, 9/11 Truthers, moon hoaxers, Holocaust deniers, or believers in the paranormal. The ideas, even the fields, are different, but flaws in reasoning and science are the same. Studies are hijacked to have scientific implications far beyond what is justified by any reasonable scientific inference. Evidence itself is abused and twisted to appear to support a predestined conclusion, while the mountains of evidence that either do not support that conclusion is either ignored or attacked as the product of a conspiracy theory or conflicts of interest. This attitude leads to “unsinkable rubber ducks,” as James Randi called them, among them irreproducible complexity, the idea that the fall of the Twin Towers was an inside job, and homeopathy.

And anti-vaccine autism quackery, more popularly known as “autism biomed.”

Because, like all pseudoscience movements, autism biomed is based on faith more than science, all these factors conspire to lead to attitudes like that of Jeff Bradstreet:

Bradstreet said he would try IVIG on every young child with autism if he could.

“Every kid with autism should have a trial of IVIG if money was not an option and IVIG was abundant,” Bradstreet said. “It makes sense to try and would be ideal to give every young child a chance at it.”

His practice offers a playroom “infusion suite” that includes a train set, a TV and toys. “IVIG is so easy for the kids once the IV is in,” Bradstreet wrote in an e-mail.

The treatment is “extremely safe,” Bradstreet said. “In 10 years we have had no significant side effects apart from short-term headaches or fevers in about 10 percent of the kids.”

Bradstreet said in an interview that he had extensively discussed the Pardo paper with a co-author, Dr. Diana Vargas, at a meeting.

Vargas tells another story.

“I do not recall a conversation with Dr. Bradstreet about the topic,” Vargas wrote in an e-mail. “I agree with Dr. Pardo and Dr. Zimmerman that our study did not suggest there being a use for IVIG in autism.”

There’s no scientific evidence that IVIG works to do anything in autism, but Bradstreet thinks that every autistic child should have a trial of it anyway, relying on anecdotes rather than clinical trials.

Now, as much as I lambaste the autism “biomeddlers,” as I sometimes call them, I realize that they are not stupid people. Some of them are actually pretty intelligent. The is that the think they understand the scientific method, but they do not. They also have a very different view of what constitutes adequate “prior plausibility” of a medical treatment to justify using it on patients. Those of us in real clinical research (yes, in reference to the anti-vaccine movement, I meant that exactly the way it sounds) understand that you can’t just try any wild idea that comes to mind on a real patient. The Belmont Report, Helsinki Accord, and the Common Rule, all designed to protect human subjects, together demand that clinical research have a large amount of preclinical data from animal, cell culture, and observational studies to justify doing clinical trials from an ethical standpoint. Absent that evidence, doing clinical trials of unproven remedies is unethical. Absent clinical trials evidence, treating patients with such unproven remedies is similarly unethical.

Although I can’t understand it from personal experience, I can understand how parents of autistic children, particularly severely autistic children, can become desperate and think that they can’t wait. I can even understand to some extent the attitude of Kim Stagliano, whom I’ve roundly criticized on multiple occasions for her support of quackery. The problem is that she and other such advocates of biomedical quackery construct a false dichotomy. To them, if scientific medicine can’t cure their children, then they feel justified in using unproven and highly implausible remedies. Some even become like Kent Heckenlively, seeking out pseudoscience after pseudoscience, quackery after quackery, until he is spending $15,000 to take his daughter to Costa Rica for “stem cell injections” straight into her cerebrospinal fluid by lumbar puncture. It’s hard to be told that their children can’t be “cured” and will never be normal. Even so, Kim Stagliano is profoundly mistaken in labeling an expose of autism quackery as the “mainstream media” telling parents of autistic children to “let your children burn.” It’s far more like warning those who have not yet fallen under the spell of various quacks about treatments that either have no basis in science, are highly implausible from a scientific standpoint, and/or result from what I call an extrapolation of existing science far beyond what the data will support. The vast majority of themare ineffective at best or harmful at worst. In this, the Chicago Tribune has done the most amazing public service for autistic children and their parents that I’ve seen since I started blogging, given the harm these “biomed” doctors do.

Although I do blame some of the more obtuse parents, such as J.B. Handley, Jenny McCarthy, and Kim Stagliano, for in the arrogance of their ignorance continuing to promote the scientifically discredited myth that vaccines cause autism and all the attendant pseudoscience that derives from it, I don’t blame most parents. It is the numerous quacks who promote the myth that autism is “vaccine injury” and use that myth to sell various nostrums who most benefit and are most to blame. Some of them may honestly think they are helping; others may be scammers; but all of them forget the very first rule of medicine: First, do no harm.