The story sounds too lurid to be true – ignoring FDA regulations, a retired chemistry professor takes a chemical used to treat toxic waste, and repackages it as a dietary supplement for disabled children. Welcome to the world of autism quackery.
The story in Sunday’s Chicago Tribune is the latest in a year-long investigation into America’s anti-vaccine movement, and its spin-off treatment industries. Last May the newspaper introduced us to <a href=”http://www.chicagotribune.com/health/chi-autism-lupron-geiers-may21,0,983359.story”>a Maryland physician</a> who purports to treat autism with Lupron, a powerful castration drug also used to treat sex offenders. In November, reporters Trine Tsouderos and Patricia Callahan showed how alternative practitioners <a href=”http://www.chicagotribune.com/health/chi-autism-science-nov23,0,6519404,full.story”>misrepresent legitimate science</a>, and <a href=”http://www.chicagotribune.com/health/chi-autism-treatments-nov22,0,7095563,full.story”>use phony lab results</a>, to push quack autism treatments. “There is a whole industry that preys on people’s fears of heavy metal poisoning,” said Dr. Carl R. Baum, director of the Center for Children’s Environmental Toxicology at Yale- New Haven Children’s Hospital, something that comes as no surprise to the nation’s 60,000 pediatricians.
The latest story introduces us to Prof. Boyd Haley, a retired former head of the Department of Chemistry at the University of Kentucky, and a micro-celebrity in the vaccine-rejection community. His wonder-drug, called OSR#1, was first formulated as an industrial chemical that separates heavy metals from polluted soil and mining drainage. Haley first repurposed the chemical as a chelating agent for treating autism, but when FDA approval was not forthcoming, he rebranded OSR as a nutritional supplement. Only one problem – the FDA says food supplements must be, uh, edible.
No wonder Haley runs from publicity he can’t control.
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.
Experts expressed dismay upon hearing children were consuming a chemical not evaluated in formal clinical trials for safety, as would be required for a drug prescribed by doctors.
Ellen Silbergeld, an expert in environmental health and a researcher funded by the National Institutes of Health studying mercury and autism at Johns Hopkins University Bloomberg School of Public Health, said she found the sale of the chemical as a supplement for children “appalling.”
“I would worry a lot about giving anything to a small child that hasn’t been scrutinized for both safety and efficacy by the FDA,” said antioxidant expert Dr. L. Jackson Roberts, a pharmacologist at Vanderbilt University School of Medicine.
The anti-vaccine movement has long relied on message control to convince parents that vaccines were more risky than the diseases they protect us against, and for too long credulous editors and reporters obliged with dutiful stenography and false balance. The Tribune’s coverage shows us that those days are numbered.
Cross-posted at AutismNewsBeat.com
Left Brain Right Brain 
Meanwhile, the hicks at NAA are having a big beg-fest over on Facebook, and it’s being promoted to hell and back on Twitter. McCarthy/Carey, GenRescue, AoA, and the whole quackery perp-list has turned out for the festivities. And the rabble of naïve, cause-hungry bystanders are all doing as they’re told.
The mindlessness of wannabe do-gooders who can’t be bothered to do their homework is depressing.
The active ingrediant in OSR#1 is N1, N3-bis(2-mercaptoethyl)isophthalamide. Thimerosal is made from ethylmercurrichloride. I wonder what word the bimbo from Johns Hopkins would use to describe this. A simple seach of a Merck manual would show which substance is by far the most toxic (and it’s not N1, N3-bis(2-mercaptoethyl)isophthalamide).
The Dietary Supplement Health and Education Act of 1994 (DHSEA) states that the term “dietary supplement”:
Maybe I’m missing something, but I don’t see that a synthetic chemical like “OSR” meets that definition in any way.
The DSHEA also has another means for testing if a “dietary supplement” meets the criteria:
In addition, the DSHEA states:
So, I still don’t see how OSR meets the definition of “dietary suuplement”. The real “meat” of the issue, however, might be contained in this part of the DSHEA:
In others words, it is up to the FDA to prove that “OSR” either isn’t safe or isn’t a dietary supplement. Given the other demands on the FDA (and the extraordinary proof it needed to “ban” ephedra), it is not surprising that they’ve not pursued “OSR”.
However, if Dr. Haley feels that he is in compliance with the DSHEA, he is using a rather eccentric reading of the law. With any luck, he’ll have the opportunity to discuss legal interpretations with a US Attorney before a child is injured or killed by his “supplement”.
Prometheus
Regarding Dr. Geier, I determined a month or two ago that his license will be up for renewal. I suggest a concerted effort to ensure that this is denied. That will be the next best thing to what I think should be done, which is to sentence him to a century or so of prison time for child abuse.
So Boyd Haley’s product is a chemical used “to treat toxic waste”. According to the EPA, any liquid that exceeds 200 ug/l mercury is hazardous waste based on toxicity characteristics. Mercury is added to multi-dose vaccine vials at a concentration of 50,000 ug/l. Sounds like the use of this product is indeed applicable.
As Far as putting Dr. Mark Geier in prison, they better leave room for the 60,000+ pediatricians!
Maggy, actually attempting to try to understand what EPA limits are, and what they are for, would have helped you avoid making an idiot of yourself.
You are implicitly claiming that huges swathes of people are openly and explicitly flouting government guidelines – yet no-one cottoned on until recently. The sheer idiocy of that conspiracy theory leaves me speechless. Yet people believe it AND hold themselves as intellectually superior to people that don’t.
Simply amazing.
Perry,
if you want to compare toxicity, try comparing thimerosal with DMSA.
The MSDS sheets show a health rating of 2 for thimerosal…the same rating for DMSA. Note that DMSA is given to autistic kids sometimes daily for years.
Thimerosal
http://www.sciencelab.com/xMSDS-Thimerosal-9925236
MSDS
http://www.sciencelab.com/xMSDS-meso_2_3_Dimercaptosuccinic_Acid-9923784
the LD50 for thimerosal is lower: 91mg/kg (mouse) for thimerosal, and 5011 mg/kg (mouse) for DMSA, a common chelating agent.
DMSA treatment for a recent study was 30mg/day. 0.6% of the LD50.
A 25microgram thimerosal dose (0.025mg) in a vaccine is 0.03% of the LD50, and is only given once (if at all anymore as thimerosal has been phase out of pediatric vaccines).
So, parents are subjecting their children to a higher toxic load, for long periods of time, in order to rid their children of toxins.
Ironic, isn’t it.