Some parents using industrial chemical as alternative autism treatment

From the Chicago Tribune:

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.

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.

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.

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, 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 that was once a part of childhood vaccines, a supposed link that numerous scientific studies have failed to prove.

"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.

Stagliano, the Web site'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 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.

Federal law allows manufacturers of dietary supplements to market them without the rigorous testing for safety and efficacy the FDA requires of drugs. Developing, testing and bringing a drug to market can cost hundreds of millions of dollars, according to some studies.

But the law does require makers of supplements containing new dietary ingredients -- such as OSR#1 -- to establish that the product can be expected to be safe.

In June 2008, an FDA senior toxicologist sent a letter to Haley that questioned on what basis the product could be expected to be safe and could be considered a dietary ingredient. According to FDA spokeswoman Siobhan DeLancey, Haley has not responded to the request for more information.

DeLancey declined to discuss OSR#1 specifically, but she said the government prohibits companies from selling a product until the safety requirement is satisfied. Penalties can include warning letters, seizure of products or criminal prosecution. DeLancey said she did not know of any actions taken against Haley or his company.

Haley did not respond to questions from the Tribune about the FDA.

The question of whether OSR#1 was developed as an industrial chemical apparently was first raised by blogger Kathleen Seidel of neurodiversity.com, who wrote several long posts about the product.

On its Web site, CTI Science flatly denies that the supplement is an industrial chelator.

"There is an Internet rumor that OSR#1 is an Industrial Chelator. Is this true?" a statement reads. Then it answers: "No."

Haley said he is marketing the product only as an antioxidant supplement.

"I am not breaking any law," Haley said. "We are being very, very careful."

Because taking chelators carries significant risks, treatments for metal poisoning are carried out under a doctor's care, with regular lab testing and only in severe cases. Among other dangers, chelating drugs can strip the body of metals necessary for health.

"Treatment of autistic children with a potent chelator is potentially hazardous and offers no benefits," Grollman said.

A note on CTI Science's Web site indicates the product has been "rarely associated with short term diarrhea, constipation or fever."

The Web site also states that OSR#1 "scavenges" hydroxyl free radicals, "allowing the body to maintain its own natural detoxifying capacity."

But Vanderbilt's Roberts said that claim is absurd.

"Hydroxyl radicals are the most reactive radicals that are formed," he wrote to the Tribune. "They oxidize everything, so in essence all molecules are hydroxyl radical scavengers."

Consumers must get the product through a dentist or doctor, according to the Web site, which lists more than 550 doctors, dentists and others who work with the company. But the Tribune was able to buy 30 capsules of OSR#1 for $60 directly from a compounding pharmacy listed on the site.

A year after the FDA requested answers about the safety of Haley's product, an autism group interviewed him about OSR#1. In the interview, posted on YouTube, Haley warns parents to be exacting when choosing what to give their children.

"Parents should know if you can't test and show the efficaciousness of anything you are taking for your child, don't do it," he said. "There are so many snake oil salesmen out there, it's just incredible."