ChicagoTribune.com: OSR#1: Industrial chemical or autism treatment? Parents giving kids compound created for use in mining, sold as supplement

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chicagotribune.com OSR#1: Industrial chemical or autism treatment? Parents

giving kids compound created for use in mining, sold as supplement

By Trine Tsouderos

http://www.chicagotribune.com/health/chi-autism-chemicaljan17,0,708616,print.sto\

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Tribune reporter

January 17, 2010

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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 '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 s

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. , 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 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. "

ttsouderos@...

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