So, imagine my mental confusion when I learned that "chelation therapy" is getting a serious look from our federally funded scientific entities. The AP had the grace to call it a "fringe" treatment, and I assume that they are using the term "treatment" quite loosely.
Apparently, the sole rationale for conducting this study--in children, actual human children--is "pressure" from parents. Excuse me? Since when did "pressure" from people with anecdotes drive federally funded "scientific" research in human children? Did somebody just have a lobotomy? Where is the process here?
For people to get a cancer therapy into the clinical trial pipeline, they must first demonstrate efficacy of the therapy in vitro and in vivo, usually two different ways in the latter. They preferably also demonstrate a mechanism, have a molecular pathway by which the therapy works. They must demonstrate that it is deliverable. They must demonstrate that the side effects, the physical costs, do not outweight the benefits. They must do all of this before they're allowed to sit a single person down in a chair and even ask them a question about a clinical study.
Yet, the director of the National Institutes of Mental Health, Dr. Thomas Insel, appears to believe that mechanism or process or demonstrations of effectiveness or issues of side effects are not that relevant, because, to quote him in the AP story, "So many moms have said, `It's saved my kids.'" Hey! Scientific method be damned! Let's do it!
Chelation can kill. Chelation is indicated for lead poisoning. Chelation is used in cases of heavy metal poisoning when the benefits of the treatment will outweight its costs.
So, let's talk science. The premise of using chelation in children with autism is that their disorder arises from heavy metal poisoning. The deeper premise is that the metal exposure comes via vaccines, more specifically by the mercury-based preservative in those vaccines, thimerosal. Really really low levels of thimerosal, which, by the way, was removed from most vaccines in the US in 2001, except for the flu vac.
Let's talk facts: Real scientific studies indicate that chelation isn't effective unless heavy metal concentrations are high. Chelation unquestionably causes dangerous side effects and even death. As it turns out, there's this metal your body needs to survive--it's called calcium--and chelators aren't too choosy about which metals to strip from your blood, so they'll take your calcium along with anything else you've got floating around in there. And your white blood cell count could plummet--bye bye, immunity! But at least you'd be "cured" of your autism.
And let's talk stupidity. I mentioned that animal studies are usually a precursor to clinical trials. Guess who's done some "animal studies"? Why, yes. Our dear friends over at Thoughtful House, whose fearless leader at least, I'm glad to say, has given over paying children at birthday parties for their blood. They've tortured some poor macaques in their quest to demonstrate...well, as you'll see below, they're not actually very clear on what it is they're trying to demonstrate. Note that the posting is dated from May of this year.
The abstracts for their work appear on the Website for Safe Minds (natch). There is no reference to peer review or actual publication. Let's take a look at the "Background" they provide (italics mine):
Background: Macaques are commonly used in pre-clinical vaccine safety testing, but the combined childhood vaccine regimen, rather than individual vaccines, has not been studied. Childhood vaccines are a possible causal factor in autism, and abnormal behaviors and anomalous amygdala growth are potentially inter-related features of this condition.
Hmmm....OK. There's actually no peer-reviewed published research confirming this statement--especially the "causal" part--and a substantial amount countering it, but let's move on.
Here's their "Objectives" section of the abstract, which immediately follows the "Background" (again, italics mine):
Objectives: The objective of this study was to compare early infant cognition and behavior with amygdala size and opioid binding in rhesus macaques receiving the recommended childhood vaccines (1994-1999), the majority of which contained the bactericidal preservative ethylmercurithiosalicylic acid (thimerosal).
Whoa, hey! Suddenly, it's not the vaccines, it's the thimerosal, which they claim was in the "majority" of childhood vaccines until 1999. Actually, there's reason enough to stop reading right there. Go here and review this table. Note the almost constant use of the words "never" and "free." Doesn't look anything like a "majority" to me, unless you mean a majority never had thimerosal and are currently free of it. Note that the MMR never had it.
Furthermore, why should anyone care in 2008--when children are still being born with autism, when genetics studies are increasingly finding more and more evidence for encoded correlative factors for autism, when thimerosal hasn't been in vaccines since 2001, except the flu vac--why should anyone give a rat's ass about thimerosal? Even if it had been clinically relevant almost 10 years ago, it's not now. That taken together with the fact that plenty of children who have never received a single thimerosal-containing vaccine have autism should be reason enough to read no further. The thought process should go like this. "(1) I think it's thimerosal causing autism. (2) Hey, look ma! No thimerosal, and there's still autism. (3) Bye bye, pet theory. Must look elsewhere." Sounds pretty straightforward, doesn't it? Yet some people seem to find it so hard to encompass.
And let's get back to that rat's ass. Where are the rats? The mice? The in vivo models that demonstrate what is necessary to demonstrate before we start flooding autistic children with chelators using federal money? An in vivo modeling that demonstrates the following:
1. There's some relevant exposure route to mercury that results in autistic symptoms in an animal model.
2. Exposure via this route elicits these symptoms at the relevant developmental time periods.
3. Exposure via this route results in detectable levels in relevant tissues.
4. These levels must produce these symptoms at environmentally relevant exposures (i.e., reflect those that people are exposed to via routes at which people are exposed).
5. Chelation ameliorates these symptoms.
Hello? Is this thing on? Has anyone seen these demonstrated? No?
And that takes us to Susan Swedo. She gets namechecked in the AP article, partly for her high profile for suggesting that OCD and a case of strep throat in childhood might be connected (woo), and then for wanting to take 120 autistic children and give half of them DMSA (a potent chelator) and the other half a placebo. And she'd test pre- and post-"treatment" mercury levels.
Ah, but there's the rub. Why give someone a chelator for heavy metal poisoning unless they have high levels of heavy metal in their blood? And if they do, then the chelator is medically indicated and it would be unethical not to give it to them. Thus, any child with the appropriate indicator for chelation would have to receive the chelation. Any child without a sufficient heavy metal load shouldn't receive it at all. The study would be either unethical or biased or both from the start. And let's not forget that anecdote, rather than a substantiated, scientific rationale, lies behind it.
And the rats themselves have actually spoken: A study has shown that DMSA exposure in rats causes, um, "lasting brain problems." Apparently, no mind is safe from some people.
Where's the science? The method? The stringency? Insel is quoted as saying that he wants to make innovation the centerpiece of "this effort as we study autism." Innovation is all fine and dandy, but that's not an opening to get creative with the scientific method just to cater to a whacky, uninformed agenda. Luckily, I'm not alone in that conviction. The proposed DMSA study is on hold, thanks to the prevailing of cooler scientific heads, and hopefully, it will stay that way.