The double standard of the anti-vaccine “autism biomed” movement never ceases to amaze me.
Imagine if you will, that a pharmaceutical company examined a chemical used for industrial purposes. Imagine further that the chemical this pharmaceutical company decided to look at originated as an industrial chelator designed to separate heavy metals from polluted soil and mining drainage. Imagine still further that that pharmaceutical company wanted to use that chemical as a treatment for autism, a chelator to be given to children. Finally, imagine that the drug company was giving this chemical to children without anything resembling any sort of competent preclincal testing or toxicology testing. Then suppose that, in order to avoid having to obtain FDA approval, the pharmaceutical company rebranded its chelating agent as a “supplement,” using the DSHEA of 1994 to bypass any need for extensive clinical trial testing for safety and efficacy in order to be able to market this chemical directly to consumers. What do you think the reaction would be of the crew at Age of Autism and other anti-vaccine blogs?
I think I know. They’d scream bloody murder. That’s what they’d do. And they’d be absolutely right.
Yet, that’s exactly what Professor Boyd Haley, a Professor of Chemistry at the University of Kentucky and former chairman of the Department of Chemistry there whose career tanked after he fell down the rabbithole of mercury-autism pseudoscience has done. Trine Tsouderos of the Chicago Tribune, the reporter who has worked on two previous excellent exposes of the anti-vaccine movement and “autism biomed” movement has documented something that I had from time to time been meaning to write about but for whatever reason hadn’t, has documented it in a third excellent story to add to her trifecta entitled OSR#1: Industrial chemical or autism treatment? Parents giving kids compound created for use in mining, sold as supplement.
An industrial chemical developed to help separate heavy metals from polluted soil and mining drainage is being sold as a dietary supplement by a luminary in the world of alternative autism treatments.
Called OSR#1, the supplement is described on its Web site as an antioxidant not meant to treat any disease. But the site lists pharmacies and doctors who sell it to parents of children with autism, and the compound has been promoted to parents on popular autism Web sites.
“I sprinkle the powder into Bella’s morning juice and onto Mia and Gianna’s gluten free waffle breakfast sandwich,” wrote Kim Stagliano, managing editor of Age of Autism and mother of three girls on the autism spectrum, in an enthusiastic post last spring. “We’ve seen some nice ‘Wows!’ from OSR.”
A search of medical journals unearthed no papers published about OSR#1, though the compound’s industrial uses have been explored in publications such as the Journal of Hazardous Materials.
Ah, testimonials for giving your autistic children an untested industrial chemical! Don’t you love the double standard?
Depressingly, but not surprisingly, not only is the anti-vaccine movement not criticizing this practice, but it’s enthusiastically embracing it. Indeed, the anti-vaccine crank blog, Age of Autism, has been enthusiastically pimping Haley’s wonder supplement for over a year now. Examples include Kim Stagliano’s glowing testimonial that attributes imporvements that could almost certainly be due to growth and development that Tsouderos quoted in her article:
My three girls began taking OSR several months ago. OSR has been the only recent addition to their treatment. I can tell you that Gianna is now in two mainstream classes in school, Mia is telling me what day it is and what’s on her schedule at school and Bella is…. well, Bella is cuter than ever and her receptive speech has improved to where she can follow directions and communicate with her PECS. I’ve seen some minor sleep disruption that passed in two of the three girls.
Because OSR makes autistic children cuter, I guess. Oddly enough, Stagliano and the crew at AoA seem not at all concerned that this chemical has not undergone adequate safety testing. Indeed, when AoA got wind that Tsouderos’s article would soon see print, it launched a pre-emptive attack. In the comments the mercury cultists even stooped so far as to make fun of Tsouderos’ first name. Stay classy, AoA. Stay classy. Oh, well. I suppose it’s not as bad as being portrayed as a baby-eating cannibal.
In any case, Haley does not like being questioned about OSR by anyone who’s not a toady, sycophant, or lackey (like AoA) whose message he can’t easily control (as he can AoA’s), and he really doesn’t like being questioned by skeptical reporters. No, he doesn’t like it at all:
Boyd Haley, president of the Lexington, Ky.-based company that produces the compound, acknowledged its industrial origins but calls his product “a food” that is “totally without toxicity.” He said he has been taking the supplement for nearly three years.
“Look, I put myself on the line,” he said. “I have taken 250 milligrams per day, on the average.”
Federal law requires manufacturers to explain why a new dietary ingredient reasonably can be expected to be safe. The Food and Drug Administration told the Tribune that Haley had not submitted sufficient information.
In an interview, Haley said that the compound had been tested on rats and that a food safety study was conducted on 10 people. Asked to provide documentation of the studies, he stopped communicating with the Tribune.
More telling is comparing Boyd Haley from four years ago to Boyd Haley now:
In a 2006 interview for the magazine Medical Veritas, Haley told a reporter from AutismOne Radio that he was interested in developing better chelators for people.
“We’ve made compounds that … work tremendously” in a test tube, he said. “However, we’ve got to show that they’re not toxic. That costs a lot of money and it’s very difficult to do, you have to have the right facilities. That’s where we’re hung up right now, the question is, ‘How do we get somebody to do these studies?’”
In January 2008 Haley changed the name of his company from Chelator Technologies Inc. to CTI Science Inc. Less than a month later, he notified the FDA he would be introducing the compound as a new dietary ingredient.
Heh. I like how Tsouderos described Medical Veritas as a “magazine” and not a journal. That’s perfect, because MV is as cranky a journal as JPANDS.
I will give Haley credit for chutzpah, tough. On the OSR website, the company denies explicitly that OSR is a chelator, even though it appears to be chemically identical to…an industrial chelator developed by Haley’s colleague David Atwood at the University of Kentucky! Curiouser and curiouser. Indeed, the ever-vigilant Kathleen Seidel first documented that this was the case a year and a half ago in a series of posts that included A Fine White Powder; The Industrial Treatment; and An Inquiry Emerges. All are worth your reading completely, as they show unequivocally that OSR is indeed a chelator and that Haley had been discussing his new “chelators” at various autism quackery conferences, his attempt to “rebrand” it as an anti-oxidant and deny its industrial past.
More interesting still is how the company claims that the drug has undergone extensive toxicity testing in both rats and humans but the results of that testing are nowhere to be found in the medical literature. Even if that’s true, I find it irresponsible to the point of recklessness to give an industrial chemical like this to children without its having undergone phase 1 clinical testing to define its toxicity and maximal tolerated dose and its having undergone phase 2 and 3 testing to show that it’s actually good for a medical condition and that the risk-benefit ratio is favorable. In the absence of this data, what we are dealing with is unethical experimentation on autistic children.
Not that this is anything new for the anti-vaccine movement. Think Lupron.
Tousderos’s story is instructive in two ways. First, it reveals more plainly than anything I can think of the utter hypocrisy and double standard behind the anti-vaccine movement and the “autism biomed” movement. They say they want “natural” treatments like dietary manipulations and supplements; yet, they are not only not fearful of sprinkling a white chemical powder made for industry on their children’s food. Secondly, it shows how the DSHEA of 1994 has allowed nearly free rein to the unscrupulous to sell virtually anything with minimal FDA interference, even if it’s selling synthetic chemicals to children. All they have to do is to declare it a “supplement,” and they can sell virtually anything.
More importantly, however, this story shows a new trend that began last year in the media. This most welcome trend involves newspapers and media outlets deemphasizing the false “balance” construct so common in lazy journalism about pseudoscientific movements like the anti-vaccine movement. In its place, at least in this case, there is a more realistic portrayal of the state of medical science. Experts say plainly that there’s nothing too this stuff and it might be dangerous. No more swallowing the claims of psuedoscience credulously, without checking out these claims and finding out that, far more often than not, they don’t check out.