Re: Re: Industrial chemical OSR#1 used as autism treatment

February 2, 2010

It shows how desperate some parents are. I just don't understand the wisdom of

eschewing the use of pharmaceuticals, but then choosing to sprinkle an

industrial chemical that hasn't been tested on humans on your kid's morning

cereal.

Robyn

________________________________

From: <jlhank80@...>

Sent: Tue, February 2, 2010 7:21:30 AM

Subject: Re: Industrial chemical OSR#1 used as autism treatment

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,

0,1654619. 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@. ..

>

February 2, 2010

The scary thing about OSR is that it was (maybe still is) being touted as

" well tested " , " all-natural " , " FDA approved " and " absolutely proven to be

safe " by some of the doctors trying to sell it. A few years ago, our

chiropracter asked me to talk to a doctor who was wanting to sell the stuff

through her office to see what I thought about OSR. I was amazed that he

couldn't tell me what was in the product but kept insisting how well tested it

was and absolutely safe. It didn't take much digging to find the FDA report

answering the OSR founder's request to sell it as a supplement/food.

Sadly, you cannot trust all doctors when they tell you something is

" safe " . Parents need to research everything they are considering giving to

their

children.

Gaylen

In a message dated 2/2/2010 9:22:31 A.M. Central Standard Time,

jlhank80@... writes:

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!Ridiculous! And also, recen

>

_http://www.latimes.http://www.lahttp://wwwhttp://wwwhttp://wwwhttp://wwwhttp://\

wwwhttp:_

(http://www.latimes.com/features/health/la-he-autism-chemical1-2010feb01,0,16546\

19.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. The

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

>

> 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@.

>

February 3, 2010

It's true that you need to research everything...including FDA approved drugs.Â

They have approved countless dangerous drugs that are later pulled because of

severe reactions including death.Â For me, FDA approved doesn't mean anything

anymore in terms of safety.Â They are a money making business and often pass up

natural things that are effective because they can't patent them and make

money.Â It's a business like everything else.Â We do need to be careful and

watch what we are putting in our bodies and our children's bodies.Â Whether

it's approved by the FDA or not.

Just wanted to throw that out there as it seems like many on this site take FDA

approval to mean " safe. "

dawn

Â

________________________________

From: " Googahly@... " <Googahly@...>

Sent: Tue, February 2, 2010 10:29:56 PM

Subject: Re: Re: Industrial chemical OSR#1 used as autism treatment