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FDA says diet supplements must be edible

June 24th, 2010 · 6 Comments · Critical thinking, Kudos

Add “snake oil salesman” to Boyd Haley’s list of public descriptors. The chemistry professor and anti-vaccine activist has been warned by the FDA that his erstwhile diet supplement, OSR#1, is a toxic brew with potentially serious side effects.

The Chicago Tribune’s Trine Tsoudeos reports that a June 17 letter from the FDA “details five violations of the Federal Food, Drug and Cosmetic Act related to his product, OSR#1,” and adds “Failing to correct such violations can result in fines, seizure of products and even criminal prosecution.”

Haley, who gave up his day job at the University of Kentucky long ago, started marketing OSR (Oxidative Stress Relief) for autistic children about two years ago. Haley originally conceived the drug as a chelating agent, but when the FDA demanded proof that it was safe and effective, he rebranded OSR as a diet supplement. The active ingredient in OSR, N,N’-bis (2-mercaptoethyl)isophthalamide, is commonly used to treat wastewater mine runoff and polluted soil, and has never been proven safe for human consumption.

Respected scientists quoted in the story expressed shock.

“It would be hard to imagine anything worse,” said Ellen Silbergeld, an expert in environmental health who is studying mercury and autism at Johns Hopkins University’s Bloomberg School of Public Health. “An industrial chemical known to be toxic — his own incomplete testing indicates it is toxic. It has no record of any therapeutic aspect of it, and it is being marketed for use in children.”

Haley is a fixture at anti-vaccine gatherings where he regularly tells parents that autism is caused by mercury poisoning. When Haley introduced OSR at an a national anti-vaccine conference in May, 2008, it was hailed by parents as a chelating agent. The drug was first marketed through Defeat Autism Now practitioners, who tested it for safety on disabled children. In a July, 2008 letter to an anti-vaccine listserve, Haley wrote:

“(We) cannot make enough OSR at this time to supply everyone that wants it. Therefore, we are only supplying OSR to MDs or ODs who are treating autistic children. This is also being done to make sure that nothing out of the ordinary happens with a minority that may be sensitive to any sulfur based antioxidant, including OSR. It is important to have a physician monitor these children as a precautionary principle. Also, I don’t want OSR to be another “pig-in-a-poke” for parents that does not work. Therefore, we are asking all initial users to agree to allow their physician to get before and after (two months later) testing for 3 items: 1. Plasma glutathione level, 2. Urinary prophyrin profile, 3. CRP levels.

According to the Tribune report, when Haley tested the drug on rats he found evidence it caused hair loss and abnormalities of the pancreas.

Anti-vaccine activists who support Haley are dismissing the FDA’s warning letter as no different than the thousands of other letters the agency sends out every year. But Sullivan at LBRB says not so fast: “Dr. Haley’s letter shows that his own safety data, data not previously made public from what I can see, indicates the drug he is selling has the potential to cause adverse reactions.”

Tsouderos first introduced readers to Haley last January. That story quoted an anti-vaccine activist and mother of three as saying “I sprinkle the powder into (my daughter’s) morning juice and onto (my other children’s) gluten free waffle breakfast sandwich. We’ve seen some nice ‘Wows!’ from OSR.”

Tsouderos’ latest investigation is her fifth story on autism quackery since May, 2009. She has previously written about a Maryland physician who chemically castrates autistic children, a Chicago doctor who wants to do the same, and the deliberate misrepresentation of scientific studies to promote unproven treatments. Last May Tsouderos and another Tribune reporter, Patricia Callahan, were recognized with a first place award by the Association of Health Care Journalists.

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