Industrial chemical OSR#1 used as autism treatment

[Guest guest]

http://www.latimes.com/features/health/la-he-autism-chemical1-2010feb01,0,165461\

9.story

Industrial chemical OSR#1 used as autism treatment

Used for toxic cleanup, it's also sold as a dietary supplement, even though it

hasn't been evaluated for safety.

By Trine Tsouderos

February 1, 2010

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 '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 s 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. , 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.

" 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.

The question of whether OSR#1 was developed as an industrial chelator apparently

was first raised by blogger Kathleen Seidel of neurodiversity.com, which covers

autism issues, who wrote several long posts about the product.

On its website, 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. "

He did not respond to questions about the FDA.

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 website indicates the product has been " rarely

associated with short term diarrhea, constipation or fever. "

The website 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. Because hydroxyl radicals

are so very reactive, he said, pretty much any molecule in the body would react

with them and in essence " scavenge " them.

Consumers must get the product through a dentist or doctor, according to the

website, which lists more than 550 doctors, dentists and others who work with

the company. But the Chicago 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@...

Copyright © 2010, The Los Angeles Times

[Guest guest]

Ridiculous! And also, recently Kirkman labs had a huge recall on supps because

they were laced with heavy metals and came from China. We have to be careful

about supplements!!! They aren't always safe!

>

>

http://www.latimes.com/features/health/la-he-autism-chemical1-2010feb01,0,165461\

9.story

>

> Industrial chemical OSR#1 used as autism treatment

> Used for toxic cleanup, it's also sold as a dietary supplement, even though it

hasn't been evaluated for safety.

>

> By Trine Tsouderos

>

> February 1, 2010

>

> 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 '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 s 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. , 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.

>

> " 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.

>

> The question of whether OSR#1 was developed as an industrial chelator

apparently was first raised by blogger Kathleen Seidel of neurodiversity.com,

which covers autism issues, who wrote several long posts about the product.

>

> On its website, 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. "

>

> He did not respond to questions about the FDA.

>

> 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 website indicates the product has been " rarely

associated with short term diarrhea, constipation or fever. "

>

> The website 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. Because hydroxyl radicals

are so very reactive, he said, pretty much any molecule in the body would react

with them and in essence " scavenge " them.

>

> Consumers must get the product through a dentist or doctor, according to the

website, which lists more than 550 doctors, dentists and others who work with

the company. But the Chicago 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@...

>

> Copyright © 2010, The Los Angeles Times

>