Used for toxic cleanup, OSR#1 also sold as a dietary supplement even though… (Antonio Perez / MCT )
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.
The supplement, called OSR#1, is described on the company website 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 websites.
"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 the Age of Autism blog 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 for toxic cleanup have been explored in publications such as the Journal of Hazardous Materials.
Boyd Haley, who is president of the Lexington, Ky.-based company that produces the OSR#1 supplement, 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 Chicago 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 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."
Antioxidant expert Dr. L. Jackson Roberts, a pharmacologist at Vanderbilt University School of Medicine, said, "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."
OSR#1 supplements are one of many risky, unproven therapies given to children with autism by doctors who say they can successfully treat the disorder, which has no cure and very few proven treatment options. Last year, Chicago Tribune reporters examined alternative treatments for autism and uncovered a trail of junk science and false hopes.
Haley, a retired professor at the University of Kentucky who once was chairman of the chemistry department, has spoken at autism conferences promoting alternative therapies. His fiery presentations connect autism and the mercury preservative that was once a common part of childhood vaccines, a proposed link that numerous scientific studies have failed to confirm.
"We need to get mad," he told an audience of hundreds at a national autism conference in Chicago last year.
One of the most prominent autism groups, Generation Rescue, once named him to its Hall of Fame, citing his "clear, thoughtful, feisty testimony and writings" about mercury.
On the Age of Autism blog, parents have hailed him as a hero for his new supplement, which Haley said "easily 1,000 people" have taken.
"Boyd Haley should be 'Man of the Year,' " wrote one reader of the blog.
Stagliano, the Age of Autism website's managing editor, declined to comment.
The company that makes the supplement, CTI Science, describes it as an antioxidant. But pharmacologist Dr. Arthur Grollman, director of the Laboratory for Chemical Biology at State University of New York at Stony Brook, said it is obvious from the product's chemical structure that it is also a "powerful chelator" -- a compound that binds to heavy metals such as mercury.
The FDA has approved several chelators as drugs to treat heavy metal poisoning. Some doctors also use the drugs -- which carry significant risks -- to treat children with autism based on the scientifically unfounded idea that their disorder is linked to toxic metals.
But the chemical being sold as OSR#1 is part of a family of chelators originally developed for industrial purposes, according to a U.S. patent issued in 2003 and assigned to the University of Kentucky Research Foundation.
A university spokesman said Haley's company has licensing rights to that patent, which discusses ways to use the compound to remove heavy metals from soil and acid mine drainage.
In a 2006 interview for the magazine Medical Veritas, Haley told a reporter from AutismOne Radio, produced by an autism parent organization, that he was interested in developing better chelators for people.