Re: Re: OSR#1 is not a dietary supplement but a toxic, unapproved drug with serious pote

[Guest guest]

Sloan

Sue the pants off the guy. It is the only way to stop this truly criminal

activity!!!! Jerks hurting children for a profit. The stuff probably sell for

$10 a ton in a mining camp and $450 an ounce in autism. Call a good lawyer and

go after a class action for no money down!!!!

This should be a poster for why the whole Homeopathy route needs to be

regulated, not all bad but the snake oil is enough to make you sick.

Bi;;

From: Sloan <Sloan_smith@...>

Subject: Re: OSR#1 is not a dietary supplement but a toxic, unapproved

drug with serious pote

Date: Friday, June 25, 2010, 5:17 PM

 

Sadly, this is one of the supplements my son was on. Sold to us a mild

mild chelator for his heavy metal load. $450.00

>

> latimes.com/news/health/sns-health-illegal-autism-therapy,0,747838.story

>

> latimes.com

> FDA: Autism 'Therapy' Illegal

> OSR#1 is not a dietary supplement but a toxic, unapproved drug with serious

potential side effects, the U.S. Food and Drug Administration warns.

> Trine Tsouderos

>

> Tribune reporter

>

> 5:18 PM PDT, June 23, 2010

>

> Advertisement

>

> A product promoted to parents of children with autism is not a harmless

dietary supplement, as claimed, but a toxic unapproved drug that lacks adequate

warnings about potential side effects, including hair loss and abnormalities of

the pancreas, the U.S. Food and Drug Administration has warned in a letter to

its maker.

>

> The FDA's June 17 letter to Boyd Haley, a retired Kentucky chemist and hero to

the autism recovery movement, details five violations of the Federal Food, Drug

and Cosmetic Act related to his product, OSR#1. Failing to correct such

violations can result in fines, seizure of products and even criminal

prosecution.

>

> The Tribune in January reported that the compound, sold as OSR#1, had been

developed to treat mining wastewater, and that it had not undergone rigorous

testing to ensure it is safe and effective. The report was part of an

investigation into unproven autism therapies offered by health providers who say

they can reverse the disorder.

>

> Haley did not reply to repeated requests for an interview Wednesday. An FDA

spokeswoman said the agency has not received any communication from Haley, who

has 15 working days from the date of the letter to respond.

>

> Last year, Haley told the Tribune: " I am not breaking any law. … We are

being very, very careful. "

>

> The Web site for Haley's company, Lexington, Ky.-based CTI Science, on

Wednesday was still promoting OSR#1 as " a toxicity free, lipid soluble

antioxidant dietary supplement, " and a reporter was able to order 30

100-milligram capsules of OSR#1 for $60 through an online pharmacy.

>

> In the interview last year, Haley called the product " a food " that is " totally

without toxicity. " Haley said the compound had been tested on rats, and a food

safety study was conducted on 10 people. Asked to provide documentation of the

research, he stopped communicating with the Tribune.

>

> The FDA letter lists side effects recorded during Haley's animal studies:

" soiling of the anogenital area, alopecia (hair loss) on the lower trunk, back

and legs, a dark substance on lower trunk and anogenital area, abnormalities of

the pancreas " and a rapid increase in normal cells contained in the lymph nodes.

>

> " It would be hard to imagine anything worse, " said Ellen Silbergeld, an expert

in environmental health who is studying mercury and autism at s Hopkins

University's Bloomberg School of Public Health. " An industrial chemical known to

be toxic — his own incomplete testing indicates it is toxic. It has no record

of any therapeutic aspect of it, and it is being marketed for use in children. "

>

> OSR#1 has been promoted on autism Web sites including Age of Autism, where

Managing Editor Kim Stagliano wrote of sprinkling the white powder on her three

daughters' breakfast sandwiches and orange juice. " We've seen some nice 'Wows!'

from OSR, " she wrote.

>

> In an e-mail, Stagliano wrote that she continues to support Haley, a regular

speaker at autism recovery conferences. " Having met Dr. Haley at conferences,

including Autism One in Chicago last month, I continue to trust his science, "

she wrote on Wednesday. " I'm sure CTI Science will address the letter

appropriately. "

>

> Pharmacologist Dr. Arthur Grollman, director of the Laboratory for Chemical

Biology at State University of New York at Stony Brook, said it is clear from

the product's chemical structure that it is 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 on the scientifically unfounded idea that their

disorder is linked to toxic metals.

>

> 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.

>

> The magazine Medical Veritas in 2006 reported that Haley said he was

interested in developing better chelators for people. " We've made compounds that

.... work tremendously " in a test tube, he was quoted as saying. " 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., records show. Less than a month later, he

notified the FDA he would be introducing the compound as a new dietary

ingredient, a designation rejected by the FDA in its recent letter.

>

> " Because OSR#1 does not bear or contain a dietary ingredient as defined (by

the food and drug act), this product does not qualify as a dietary supplement, "

the letter states.

>

> Instead, according to the letter, it is a new drug. Winning FDA approval

requires proof of safety and efficacy through clinical trials, a process that

can cost hundreds of millions of dollars and take many years.

>

> " Anything might be a cure for anything else, but the odds are it will do

nothing and it might very well be toxic, " said Mailman, a

neuropharmacologist at Penn State University. " That is why drug discovery and

development is so expensive. "

>

> Silbergeld said the product represents a clear example of endangerment of

public health and that the FDA should stop CTI Science from selling it

immediately. She drew a comparison to a city's drinking water system: If

contamination is found, she said, " they turn off the pumps. "

>

> " They don't have to engage in a long discussion with you, " Silbergeld said.

" It would be hard to imagine a more clear example of immediate endangerment of

public health. Turn off the pump. "

>

> Copyright © 2010, Chicago Tribune

>

[Guest guest]

This is disgusting. What kind of sociopath preys on desperate parents with sick

children!

I'm not much for lawsuits, but this guys needs to be stopped!

Robynn

________________________________

From: Bill klimas <klimas_bill@...>

Sent: Fri, June 25, 2010 3:13:14 PM

Subject: Re: Re: OSR#1 is not a dietary supplement but a toxic,

unapproved drug with serious pote

 

Sloan

Sue the pants off the guy. It is the only way to stop this truly criminal

activity!!!! Jerks hurting children for a profit. The stuff probably sell for

$10 a ton in a mining camp and $450 an ounce in autism. Call a good lawyer and

go after a class action for no money down!!!!

This should be a poster for why the whole Homeopathy route needs to be

regulated, not all bad but the snake oil is enough to make you sick.

Bi;;

From: Sloan <Sloan_smith@...>

Subject: Re: OSR#1 is not a dietary supplement but a toxic, unapproved

drug with serious pote

Date: Friday, June 25, 2010, 5:17 PM

 

Sadly, this is one of the supplements my son was on. Sold to us a mild mild

chelator for his heavy metal load. $450.00

>

> latimes.com/news/health/sns-health-illegal-autism-therapy,0,747838.story

>

> latimes.com

> FDA: Autism 'Therapy' Illegal

> OSR#1 is not a dietary supplement but a toxic, unapproved drug with serious

potential side effects, the U.S. Food and Drug Administration warns.

> Trine Tsouderos

>

> Tribune reporter

>

> 5:18 PM PDT, June 23, 2010

>

> Advertisement

>

> A product promoted to parents of children with autism is not a harmless

dietary supplement, as claimed, but a toxic unapproved drug that lacks adequate

warnings about potential side effects, including hair loss and abnormalities of

the pancreas, the U.S. Food and Drug Administration has warned in a letter to

its maker.

>

> The FDA's June 17 letter to Boyd Haley, a retired Kentucky chemist and hero to

the autism recovery movement, details five violations of the Federal Food, Drug

and Cosmetic Act related to his product, OSR#1. Failing to correct such

violations can result in fines, seizure of products and even criminal

prosecution.

>

> The Tribune in January reported that the compound, sold as OSR#1, had been

developed to treat mining wastewater, and that it had not undergone rigorous

testing to ensure it is safe and effective. The report was part of an

investigation into unproven autism therapies offered by health providers who say

they can reverse the disorder.

>

> Haley did not reply to repeated requests for an interview Wednesday. An FDA

spokeswoman said the agency has not received any communication from Haley, who

has 15 working days from the date of the letter to respond.

>

> Last year, Haley told the Tribune: " I am not breaking any law. … We are

being very, very careful. "

>

> The Web site for Haley's company, Lexington, Ky.-based CTI Science, on

Wednesday was still promoting OSR#1 as " a toxicity free, lipid soluble

antioxidant dietary supplement, " and a reporter was able to order 30

100-milligram capsules of OSR#1 for $60 through an online pharmacy.

>

> In the interview last year, Haley called the product " a food " that is " totally

without toxicity. " Haley said the compound had been tested on rats, and a food

safety study was conducted on 10 people. Asked to provide documentation of the

research, he stopped communicating with the Tribune.

>

> The FDA letter lists side effects recorded during Haley's animal studies:

" soiling of the anogenital area, alopecia (hair loss) on the lower trunk, back

and legs, a dark substance on lower trunk and anogenital area, abnormalities of

the pancreas " and a rapid increase in normal cells contained in the lymph nodes.

>

> " It would be hard to imagine anything worse, " said Ellen Silbergeld, an expert

in environmental health who is studying mercury and autism at s Hopkins

University's Bloomberg School of Public Health. " An industrial chemical known to

be toxic — his own incomplete testing indicates it is toxic. It has no record

of any therapeutic aspect of it, and it is being marketed for use in children. "

>

> OSR#1 has been promoted on autism Web sites including Age of Autism, where

Managing Editor Kim Stagliano wrote of sprinkling the white powder on her three

daughters' breakfast sandwiches and orange juice. " We've seen some nice 'Wows!'

from OSR, " she wrote.

>

> In an e-mail, Stagliano wrote that she continues to support Haley, a regular

speaker at autism recovery conferences. " Having met Dr. Haley at conferences,

including Autism One in Chicago last month, I continue to trust his science, "

she wrote on Wednesday. " I'm sure CTI Science will address the letter

appropriately. "

>

> Pharmacologist Dr. Arthur Grollman, director of the Laboratory for Chemical

Biology at State University of New York at Stony Brook, said it is clear from

the product's chemical structure that it is 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 on the scientifically unfounded idea that their

disorder is linked to toxic metals.

>

> 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.

>

> The magazine Medical Veritas in 2006 reported that Haley said he was

interested in developing better chelators for people. " We've made compounds that

.... work tremendously " in a test tube, he was quoted as saying. " 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., records show. Less than a month later, he

notified the FDA he would be introducing the compound as a new dietary

ingredient, a designation rejected by the FDA in its recent letter.

>

> " Because OSR#1 does not bear or contain a dietary ingredient as defined (by

the food and drug act), this product does not qualify as a dietary supplement, "

the letter states.

>

> Instead, according to the letter, it is a new drug. Winning FDA approval

requires proof of safety and efficacy through clinical trials, a process that

can cost hundreds of millions of dollars and take many years.

>

> " Anything might be a cure for anything else, but the odds are it will do

nothing and it might very well be toxic, " said Mailman, a

neuropharmacologist at Penn State University. " That is why drug discovery and

development is so expensive. "

>

> Silbergeld said the product represents a clear example of endangerment of

public health and that the FDA should stop CTI Science from selling it

immediately. She drew a comparison to a city's drinking water system: If

contamination is found, she said, " they turn off the pumps. "

>

> " They don't have to engage in a long discussion with you, " Silbergeld said.

" It would be hard to imagine a more clear example of immediate endangerment of

public health. Turn off the pump. "

>

> Copyright © 2010, Chicago Tribune

>

[Guest guest]

I am thinking about it, after all the money, time and anguish we spent on this

guy.  I think we can all pass on a few lessons.

1. Don't use a doctor who has a commercial intrest in the supplements they sell

2. Use an actual doctor

3. If the practinioner has a side in an unrelated business (weight loss,

suppresses memory syndrome, botox...) suspect that they are out for a quick buck

4.  If they have practiced in multiple states they have probably faced lawsuits

and had their licenses revoked

Pass it on.

From: Sloan <Sloan_smith@...>

Subject: Re: OSR#1 is not a dietary supplement but a toxic, unapproved

drug with serious pote

Date: Friday, June 25, 2010, 5:17 PM

 

Sadly, this is one of the supplements my son was on. Sold to us a mild mild

chelator for his heavy metal load. $450.00

>

> latimes.com/news/health/sns-health-illegal-autism-therapy,0,747838.story

>

> latimes.com

> FDA: Autism 'Therapy' Illegal

> OSR#1 is not a dietary supplement but a toxic, unapproved drug with serious

potential side effects, the U.S. Food and Drug Administration warns.

> Trine Tsouderos

>

> Tribune reporter

>

> 5:18 PM PDT, June 23, 2010

>

> Advertisement

>

> A product promoted to parents of children with autism is not a harmless

dietary supplement, as claimed, but a toxic unapproved drug that lacks adequate

warnings about potential side effects, including hair loss and abnormalities of

the pancreas, the U.S. Food and Drug Administration has warned in a letter to

its maker.

>

> The FDA's June 17 letter to Boyd Haley, a retired Kentucky chemist and hero to

the autism recovery movement, details five violations of the Federal Food, Drug

and Cosmetic Act related to his product, OSR#1. Failing to correct such

violations can result in fines, seizure of products and even criminal

prosecution.

>

> The Tribune in January reported that the compound, sold as OSR#1, had been

developed to treat mining wastewater, and that it had not undergone rigorous

testing to ensure it is safe and effective. The report was part of an

investigation into unproven autism therapies offered by health providers who say

they can reverse the disorder.

>

> Haley did not reply to repeated requests for an interview Wednesday. An FDA

spokeswoman said the agency has not received any communication from Haley, who

has 15 working days from the date of the letter to respond.

>

> Last year, Haley told the Tribune: " I am not breaking any law. … We are

being very, very careful. "

>

> The Web site for Haley's company, Lexington, Ky.-based CTI Science, on

Wednesday was still promoting OSR#1 as " a toxicity free, lipid soluble

antioxidant dietary supplement, " and a reporter was able to order 30

100-milligram capsules of OSR#1 for $60 through an online pharmacy.

>

> In the interview last year, Haley called the product " a food " that is " totally

without toxicity. " Haley said the compound had been tested on rats, and a food

safety study was conducted on 10 people. Asked to provide documentation of the

research, he stopped communicating with the Tribune.

>

> The FDA letter lists side effects recorded during Haley's animal studies:

" soiling of the anogenital area, alopecia (hair loss) on the lower trunk, back

and legs, a dark substance on lower trunk and anogenital area, abnormalities of

the pancreas " and a rapid increase in normal cells contained in the lymph nodes.

>

> " It would be hard to imagine anything worse, " said Ellen Silbergeld, an expert

in environmental health who is studying mercury and autism at s Hopkins

University's Bloomberg School of Public Health. " An industrial chemical known to

be toxic — his own incomplete testing indicates it is toxic. It has no record

of any therapeutic aspect of it, and it is being marketed for use in children. "

>

> OSR#1 has been promoted on autism Web sites including Age of Autism, where

Managing Editor Kim Stagliano wrote of sprinkling the white powder on her three

daughters' breakfast sandwiches and orange juice. " We've seen some nice 'Wows!'

from OSR, " she wrote.

>

> In an e-mail, Stagliano wrote that she continues to support Haley, a regular

speaker at autism recovery conferences. " Having met Dr. Haley at conferences,

including Autism One in Chicago last month, I continue to trust his science, "

she wrote on Wednesday. " I'm sure CTI Science will address the letter

appropriately. "

>

> Pharmacologist Dr. Arthur Grollman, director of the Laboratory for Chemical

Biology at State University of New York at Stony Brook, said it is clear from

the product's chemical structure that it is 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 on the scientifically unfounded idea that their

disorder is linked to toxic metals.

>

> 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.

>

> The magazine Medical Veritas in 2006 reported that Haley said he was

interested in developing better chelators for people. " We've made compounds that

.... work tremendously " in a test tube, he was quoted as saying. " 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., records show. Less than a month later, he

notified the FDA he would be introducing the compound as a new dietary

ingredient, a designation rejected by the FDA in its recent letter.

>

> " Because OSR#1 does not bear or contain a dietary ingredient as defined (by

the food and drug act), this product does not qualify as a dietary supplement, "

the letter states.

>

> Instead, according to the letter, it is a new drug. Winning FDA approval

requires proof of safety and efficacy through clinical trials, a process that

can cost hundreds of millions of dollars and take many years.

>

> " Anything might be a cure for anything else, but the odds are it will do

nothing and it might very well be toxic, " said Mailman, a

neuropharmacologist at Penn State University. " That is why drug discovery and

development is so expensive. "

>

> Silbergeld said the product represents a clear example of endangerment of

public health and that the FDA should stop CTI Science from selling it

immediately. She drew a comparison to a city's drinking water system: If

contamination is found, she said, " they turn off the pumps. "

>

> " They don't have to engage in a long discussion with you, " Silbergeld said.

" It would be hard to imagine a more clear example of immediate endangerment of

public health. Turn off the pump. "

>

> Copyright © 2010, Chicago Tribune

>

[Guest guest]

Just by the article, he has produced enough evidence to be criminally negligent.

A good lawyer would track down all of his other customers and produce a suit

that would generate punitive damages.This is not about the dollars but about

setting an example that the Autism community will not tolerate this kind of

behavior. Strike while the iron is hot as are the parents!!!

This is the system, wok within it and we can get things done!

From: Sloan <Sloan_smith@...>

Subject: Re: OSR#1 is not a dietary supplement but a toxic, unapproved

drug with serious pote

Date: Friday, June 25, 2010, 5:17 PM

Sadly, this is one of the supplements my son was on. Sold to us a mild mild

chelator for his heavy metal load. $450.00

>

> latimes.com/news/health/sns-health-illegal-autism-therapy,0,747838.story

>

> latimes.com

> FDA: Autism 'Therapy' Illegal

> OSR#1 is not a dietary supplement but a toxic, unapproved drug with serious

potential side effects, the U.S. Food and Drug Administration warns.

> Trine Tsouderos

>

> Tribune reporter

>

> 5:18 PM PDT, June 23, 2010

>

> Advertisement

>

> A product promoted to parents of children with autism is not a harmless

dietary supplement, as claimed, but a toxic unapproved drug that lacks adequate

warnings about potential side effects, including hair loss and abnormalities of

the pancreas, the U.S. Food and Drug Administration has warned in a letter to

its maker.

>

> The FDA's June 17 letter to Boyd Haley, a retired Kentucky chemist and hero to

the autism recovery movement, details five violations of the Federal Food, Drug

and Cosmetic Act related to his product, OSR#1. Failing to correct such

violations can result in fines, seizure of products and even criminal

prosecution.

>

> The Tribune in January reported that the compound, sold as OSR#1, had been

developed to treat mining wastewater, and that it had not undergone rigorous

testing to ensure it is safe and effective. The report was part of an

investigation into unproven autism therapies offered by health providers who say

they can reverse the disorder.

>

> Haley did not reply to repeated requests for an interview Wednesday. An FDA

spokeswoman said the agency has not received any communication from Haley, who

has 15 working days from the date of the letter to respond.

>

> Last year, Haley told the Tribune: " I am not breaking any law. … We are

being very, very careful. "

>

> The Web site for Haley's company, Lexington, Ky.-based CTI Science, on

Wednesday was still promoting OSR#1 as " a toxicity free, lipid soluble

antioxidant dietary supplement, " and a reporter was able to order 30

100-milligram capsules of OSR#1 for $60 through an online pharmacy.

>

> In the interview last year, Haley called the product " a food " that is " totally

without toxicity. " Haley said the compound had been tested on rats, and a food

safety study was conducted on 10 people. Asked to provide documentation of the

research, he stopped communicating with the Tribune.

>

> The FDA letter lists side effects recorded during Haley's animal studies:

" soiling of the anogenital area, alopecia (hair loss) on the lower trunk, back

and legs, a dark substance on lower trunk and anogenital area, abnormalities of

the pancreas " and a rapid increase in normal cells contained in the lymph nodes.

>

> " It would be hard to imagine anything worse, " said Ellen Silbergeld, an expert

in environmental health who is studying mercury and autism at s Hopkins

University's Bloomberg School of Public Health. " An industrial chemical known to

be toxic — his own incomplete testing indicates it is toxic. It has no record

of any therapeutic aspect of it, and it is being marketed for use in children. "

>

> OSR#1 has been promoted on autism Web sites including Age of Autism, where

Managing Editor Kim Stagliano wrote of sprinkling the white powder on her three

daughters' breakfast sandwiches and orange juice. " We've seen some nice 'Wows!'

from OSR, " she wrote.

>

> In an e-mail, Stagliano wrote that she continues to support Haley, a regular

speaker at autism recovery conferences. " Having met Dr. Haley at conferences,

including Autism One in Chicago last month, I continue to trust his science, "

she wrote on Wednesday. " I'm sure CTI Science will address the letter

appropriately. "

>

> Pharmacologist Dr. Arthur Grollman, director of the Laboratory for Chemical

Biology at State University of New York at Stony Brook, said it is clear from

the product's chemical structure that it is 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 on the scientifically unfounded idea that their

disorder is linked to toxic metals.

>

> 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.

>

> The magazine Medical Veritas in 2006 reported that Haley said he was

interested in developing better chelators for people. " We've made compounds that

.... work tremendously " in a test tube, he was quoted as saying. " 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., records show. Less than a month later, he

notified the FDA he would be introducing the compound as a new dietary

ingredient, a designation rejected by the FDA in its recent letter.

>

> " Because OSR#1 does not bear or contain a dietary ingredient as defined (by

the food and drug act), this product does not qualify as a dietary supplement, "

the letter states.

>

> Instead, according to the letter, it is a new drug. Winning FDA approval

requires proof of safety and efficacy through clinical trials, a process that

can cost hundreds of millions of dollars and take many years.

>

> " Anything might be a cure for anything else, but the odds are it will do

nothing and it might very well be toxic, " said Mailman, a

neuropharmacologist at Penn State University. " That is why drug discovery and

development is so expensive. "

>

> Silbergeld said the product represents a clear example of endangerment of

public health and that the FDA should stop CTI Science from selling it

immediately. She drew a comparison to a city's drinking water system: If

contamination is found, she said, " they turn off the pumps. "

>

> " They don't have to engage in a long discussion with you, " Silbergeld said.

" It would be hard to imagine a more clear example of immediate endangerment of

public health. Turn off the pump. "

>

> Copyright © 2010, Chicago Tribune

>

[Guest guest]

I totally agree, Bill. This is why civil suits were created!

Robyn

 

________________________________

From: Bill klimas <klimas_bill@...>

Sent: Fri, June 25, 2010 5:05:10 PM

Subject: Re: Re: OSR#1 is not a dietary supplement but a toxic,

unapproved drug with serious pote

Just by the article, he has produced enough evidence to be criminally negligent.

A good lawyer would track down all of his other customers and produce a suit

that would generate punitive damages.This is not about the dollars but about

setting an example that the Autism community will not tolerate this kind of

behavior. Strike while the iron is hot as are the parents!!!

This is the system, wok within it and we can get things done!

From: Sloan <Sloan_smith@...>

Subject: Re: OSR#1 is not a dietary supplement but a toxic, unapproved

drug with serious pote

Date: Friday, June 25, 2010, 5:17 PM

Sadly, this is one of the supplements my son was on. Sold to us a mild mild

chelator for his heavy metal load. $450.00

>

> latimes.com/news/health/sns-health-illegal-autism-therapy,0,747838.story

>

> latimes.com

> FDA: Autism 'Therapy' Illegal

> OSR#1 is not a dietary supplement but a toxic, unapproved drug with serious

potential side effects, the U.S. Food and Drug Administration warns.

> Trine Tsouderos

>

> Tribune reporter

>

> 5:18 PM PDT, June 23, 2010

>

> Advertisement

>

> A product promoted to parents of children with autism is not a harmless

dietary supplement, as claimed, but a toxic unapproved drug that lacks adequate

warnings about potential side effects, including hair loss and abnormalities of

the pancreas, the U.S. Food and Drug Administration has warned in a letter to

its maker.

>

> The FDA's June 17 letter to Boyd Haley, a retired Kentucky chemist and hero to

the autism recovery movement, details five violations of the Federal Food, Drug

and Cosmetic Act related to his product, OSR#1. Failing to correct such

violations can result in fines, seizure of products and even criminal

prosecution.

>

> The Tribune in January reported that the compound, sold as OSR#1, had been

developed to treat mining wastewater, and that it had not undergone rigorous

testing to ensure it is safe and effective. The report was part of an

investigation into unproven autism therapies offered by health providers who say

they can reverse the disorder.

>

> Haley did not reply to repeated requests for an interview Wednesday. An FDA

spokeswoman said the agency has not received any communication from Haley, who

has 15 working days from the date of the letter to respond.

>

> Last year, Haley told the Tribune: " I am not breaking any law. … We are

being very, very careful. "

>

> The Web site for Haley's company, Lexington, Ky.-based CTI Science, on

Wednesday was still promoting OSR#1 as " a toxicity free, lipid soluble

antioxidant dietary supplement, " and a reporter was able to order 30

100-milligram capsules of OSR#1 for $60 through an online pharmacy.

>

> In the interview last year, Haley called the product " a food " that is " totally

without toxicity. " Haley said the compound had been tested on rats, and a food

safety study was conducted on 10 people. Asked to provide documentation of the

research, he stopped communicating with the Tribune.

>

> The FDA letter lists side effects recorded during Haley's animal studies:

" soiling of the anogenital area, alopecia (hair loss) on the lower trunk, back

and legs, a dark substance on lower trunk and anogenital area, abnormalities of

the pancreas " and a rapid increase in normal cells contained in the lymph nodes.

>

> " It would be hard to imagine anything worse, " said Ellen Silbergeld, an expert

in environmental health who is studying mercury and autism at s Hopkins

University's Bloomberg School of Public Health. " An industrial chemical known to

be toxic — his own incomplete testing indicates it is toxic. It has no record

of any therapeutic aspect of it, and it is being marketed for use in children. "

>

> OSR#1 has been promoted on autism Web sites including Age of Autism, where

Managing Editor Kim Stagliano wrote of sprinkling the white powder on her three

daughters' breakfast sandwiches and orange juice. " We've seen some nice 'Wows!'

from OSR, " she wrote.

>

> In an e-mail, Stagliano wrote that she continues to support Haley, a regular

speaker at autism recovery conferences. " Having met Dr. Haley at conferences,

including Autism One in Chicago last month, I continue to trust his science, "

she wrote on Wednesday. " I'm sure CTI Science will address the letter

appropriately. "

>

> Pharmacologist Dr. Arthur Grollman, director of the Laboratory for Chemical

Biology at State University of New York at Stony Brook, said it is clear from

the product's chemical structure that it is 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 on the scientifically unfounded idea that their

disorder is linked to toxic metals.

>

> 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.

>

> The magazine Medical Veritas in 2006 reported that Haley said he was

interested in developing better chelators for people. " We've made compounds that

.... work tremendously " in a test tube, he was quoted as saying. " 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., records show. Less than a month later, he

notified the FDA he would be introducing the compound as a new dietary

ingredient, a designation rejected by the FDA in its recent letter.

>

> " Because OSR#1 does not bear or contain a dietary ingredient as defined (by

the food and drug act), this product does not qualify as a dietary supplement, "

the letter states.

>

> Instead, according to the letter, it is a new drug. Winning FDA approval

requires proof of safety and efficacy through clinical trials, a process that

can cost hundreds of millions of dollars and take many years.

>

> " Anything might be a cure for anything else, but the odds are it will do

nothing and it might very well be toxic, " said Mailman, a

neuropharmacologist at Penn State University. " That is why drug discovery and

development is so expensive. "

>

> Silbergeld said the product represents a clear example of endangerment of

public health and that the FDA should stop CTI Science from selling it

immediately. She drew a comparison to a city's drinking water system: If

contamination is found, she said, " they turn off the pumps. "

>

> " They don't have to engage in a long discussion with you, " Silbergeld said.

" It would be hard to imagine a more clear example of immediate endangerment of

public health. Turn off the pump. "

>

> Copyright © 2010, Chicago Tribune

>

[Guest guest]

Sloane,

I have almost recovered my child on OSR. I do not currently do , but will

see Dr Goldberg if I can't fully recover my son biomedically in the next year.

(It's looking pretty good though) I absolutely respect what Dr G is doing for

children, but didn't want to abandon an intervention I've been doing with sucess

for 2 years. Anyway........I just wanted to explain why I'm on the group list if

I'm not actively doing . I hope not to offend anyone in the group. You guys

are awesome and I respect your protocol!

I wanted you to know there was a response to the Tribune article from Boyd

Haley's. I hope it makes you feel better about your choice to use OSR.

This is what he wrote:

The article by the Chicago Tribune and the warning letter from the FDA are

fueled by a misconception.  The chemical name of OSR#1 is

N1N3-bis-(2-mercaptoethyl)isophthalamide which makes it sound to many like an

exceptionally complex chemical with no natural components.  However, looking at

the structure of OSR it is easily seen that it contains a benzoate group (found

in cranberries) and two cystamines (a metabolite of cysteine and found in all

mammalian cells and on the terminal end of Coenzyme-A). The coupling of

cystamine to benzoate is through the same type of amide linkage found in

connecting amino acids to produce protein.

 

The FDA description of a dietary supplement as extracted from their letter is:

To be a dietary supplement, a product must, among other things, " bear [ ] or

contain [ ] one or more...dietary ingredients " as defined in section 20 I (11)(

I) of the Act, 21 U.S.c.§ 321 (ff)( I). Section 20 1(11)( 1) or the Act defines

" dietary ingredient " as a vitamin, mineral, amino acid, herb or other botanical,

or dietary substance for use by man to supplement the diet by increasing the

total dietary intake. or a concentrate, metabolite, constituent, extract or

combination of any dietary ingredient from the preceding categories.   Using

this description it is obvious to a biochemist that OSR#1 bears and contains two

dietary ingredients.  It appears as if the chemical name (which we had to place

on the label) has confused this issue.  Hopefully this can be cleared up.

 

Regarding the toxic effects the FDA and Chicago Tribune comment on.  The

diarrhea and pancreas problems reported occurred during an UP/DOWN study to

determine the LD-50 of OSR, that is “what amount of OSR would cause 50% of the

test animals to die?â€.  Problem was that during the experimentation, even to

reach the 5 grams/kg body weight they finally achieved, the researchers had to

give the OSR (dissolved in corn oil) at three different times during the day. 

Even then the test animals showed no weight loss or ataxia or other signs of

toxicity except diarrhea and a pancreas abnormality.  They were giving these

animals massive doses (e.g. 1,000 to 5,000 times the recommended level for

humans) trying to kill them.  Almost all supplemental materials would cause

some problems at these levels and the LD-50 of OSR (decided to be greater than 5

g/kg) is considerably below the LD-50 of some commonly used supplemental

compounds used today. 

For example, a 220 lb (100 kg) person would have to take 500 grams/day or 5,000

OSR capsules/day to reach the 5 g/kg body weight level.  We recommend 1 capsule

or 0.1 gram/day level usage (i.e. 100mg) which is 5,000 times below the 5

gram/kg level in this example.  When the long term study was done and the

maximum amount tested was 1 gram/kg body weight the diarrhea and pancreas issues

disappeared.  At 1 gram/kg a 220 lb person would have to take 1,000

capsules/day to reach a level where no toxic effects were noted.  In it’s

initial letter responding to our Premarket Notification the FDA did not mention

these test animal toxicity studies as being of any concern.  I don’t know

what changed their minds to make them go back and review this, but their review

and the comments in this recent letter do not reflect a concern I would agree

with.

 

Also, OSR has never been promoted by CTI Science as a treatment for any specific

disease and FDA disclaimers are on every package.

 

I would point out that the FDA warning letter was not based on any reported

adverse effect.  Since CTI Science has been selling OSR (about 2 years) we have

not had one severe adverse effect reported to our FDA based adverse effect

reporting system.  We have had many very positive responses from physicians and

parents regarding the use of OSR.  However, the fact is that I have to obey the

FDA directive or risk damage to my co-workers as well as myself, and/or spend

the funds to legally counter the FDA decision.  What to do is under study. 

But from the above, you can see why I strongly believe that OSR is a dietary

supplement by FDA criteria and that it is without detectable toxicity at the

levels recommended.

 

Boyd E. Haley, PhD

________________________________

From: Sloan <Sloan_smith@...>

Sent: Fri, June 25, 2010 5:17:11 PM

Subject: Re: OSR#1 is not a dietary supplement but a toxic, unapproved

drug with serious pote

 

Sadly, this is one of the supplements my son was on. Sold to us a mild mild

chelator for his heavy metal load. $450.00

>

> latimes.com/news/health/sns-health-illegal-autism-therapy,0,747838.story

>

> latimes.com

> FDA: Autism 'Therapy' Illegal

> OSR#1 is not a dietary supplement but a toxic, unapproved drug with serious

potential side effects, the U.S. Food and Drug Administration warns.

> Trine Tsouderos

>

> Tribune reporter

>

> 5:18 PM PDT, June 23, 2010

>

> Advertisement

>

> A product promoted to parents of children with autism is not a harmless

dietary supplement, as claimed, but a toxic unapproved drug that lacks adequate

warnings about potential side effects, including hair loss and abnormalities of

the pancreas, the U.S. Food and Drug Administration has warned in a letter to

its maker.

>

> The FDA's June 17 letter to Boyd Haley, a retired Kentucky chemist and hero to

the autism recovery movement, details five violations of the Federal Food, Drug

and Cosmetic Act related to his product, OSR#1. Failing to correct such

violations can result in fines, seizure of products and even criminal

prosecution.

>

> The Tribune in January reported that the compound, sold as OSR#1, had been

developed to treat mining wastewater, and that it had not undergone rigorous

testing to ensure it is safe and effective. The report was part of an

investigation into unproven autism therapies offered by health providers who say

they can reverse the disorder.

>

> Haley did not reply to repeated requests for an interview Wednesday. An FDA

spokeswoman said the agency has not received any communication from Haley, who

has 15 working days from the date of the letter to respond.

>

> Last year, Haley told the Tribune: " I am not breaking any law. … We are

being very, very careful. "

>

> The Web site for Haley's company, Lexington, Ky.-based CTI Science, on

Wednesday was still promoting OSR#1 as " a toxicity free, lipid soluble

antioxidant dietary supplement, " and a reporter was able to order 30

100-milligram capsules of OSR#1 for $60 through an online pharmacy.

>

> In the interview last year, Haley called the product " a food " that is " totally

without toxicity. " Haley said the compound had been tested on rats, and a food

safety study was conducted on 10 people. Asked to provide documentation of the

research, he stopped communicating with the Tribune.

>

> The FDA letter lists side effects recorded during Haley's animal studies:

" soiling of the anogenital area, alopecia (hair loss) on the lower trunk, back

and legs, a dark substance on lower trunk and anogenital area, abnormalities of

the pancreas " and a rapid increase in normal cells contained in the lymph nodes.

>

> " It would be hard to imagine anything worse, " said Ellen Silbergeld, an expert

in environmental health who is studying mercury and autism at s Hopkins

University's Bloomberg School of Public Health. " An industrial chemical known to

be toxic — his own incomplete testing indicates it is toxic. It has no record

of any therapeutic aspect of it, and it is being marketed for use in children. "

>

> OSR#1 has been promoted on autism Web sites including Age of Autism, where

Managing Editor Kim Stagliano wrote of sprinkling the white powder on her three

daughters' breakfast sandwiches and orange juice. " We've seen some nice 'Wows!'

from OSR, " she wrote.

>

> In an e-mail, Stagliano wrote that she continues to support Haley, a regular

speaker at autism recovery conferences. " Having met Dr. Haley at conferences,

including Autism One in Chicago last month, I continue to trust his science, "

she wrote on Wednesday. " I'm sure CTI Science will address the letter

appropriately. "

>

> Pharmacologist Dr. Arthur Grollman, director of the Laboratory for Chemical

Biology at State University of New York at Stony Brook, said it is clear from

the product's chemical structure that it is 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 on the scientifically unfounded idea that their

disorder is linked to toxic metals.

>

> 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.

>

> The magazine Medical Veritas in 2006 reported that Haley said he was

interested in developing better chelators for people. " We've made compounds that

.... work tremendously " in a test tube, he was quoted as saying. " 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., records show. Less than a month later, he

notified the FDA he would be introducing the compound as a new dietary

ingredient, a designation rejected by the FDA in its recent letter.

>

> " Because OSR#1 does not bear or contain a dietary ingredient as defined (by

the food and drug act), this product does not qualify as a dietary supplement, "

the letter states.

>

> Instead, according to the letter, it is a new drug. Winning FDA approval

requires proof of safety and efficacy through clinical trials, a process that

can cost hundreds of millions of dollars and take many years.

>

> " Anything might be a cure for anything else, but the odds are it will do

nothing and it might very well be toxic, " said Mailman, a

neuropharmacologist at Penn State University. " That is why drug discovery and

development is so expensive. "

>

> Silbergeld said the product represents a clear example of endangerment of

public health and that the FDA should stop CTI Science from selling it

immediately. She drew a comparison to a city's drinking water system: If

contamination is found, she said, " they turn off the pumps. "

>

> " They don't have to engage in a long discussion with you, " Silbergeld said.

" It would be hard to imagine a more clear example of immediate endangerment of

public health. Turn off the pump. "

>

> Copyright © 2010, Chicago Tribune

>

[Guest guest]

What works is true for that indiviual each of us is trying to find what would

help thier child, be that that right or wrong in another's eyes. Its subjective

what is true is true no matter how wrong someone else may thing it is provided

its for the good and does not harm the child.

Kavita

The article by the Chicago Tribune and the warning letter from the FDA are

fueled by a misconception.  The chemical name of OSR#1 is

N1N3-bis-(2-mercaptoethyl)isophthalamide which makes it sound to many like an

exceptionally complex chemical with no natural components.  However, looking at

the structure of OSR it is easily seen that it contains a benzoate group (found

in cranberries) and two cystamines (a metabolite of cysteine and found in all

mammalian cells and on the terminal end of Coenzyme-A). The coupling of

cystamine to benzoate is through the same type of amide linkage found in

connecting amino acids to produce protein.

 

The FDA description of a dietary supplement as extracted from their letter is:

To be a dietary supplement, a product must, among other things, " bear [ ] or

contain [ ] one or more...dietary ingredients " as defined in section 20 I (11)(

I) of the Act, 21 U.S.c.§ 321 (ff)( I). Section 20 1(11)( 1) or the Act defines

" dietary ingredient " as a vitamin, mineral, amino acid, herb or other botanical,

or dietary substance for use by man to supplement the diet by increasing the

total dietary intake. or a concentrate, metabolite, constituent, extract or

combination of any dietary ingredient from the preceding categories.   Using

this description it is obvious to a biochemist that OSR#1 bears and contains two

dietary ingredients.  It appears as if the chemical name (which we had to place

on the label) has confused this issue.  Hopefully this can be cleared up.

 

Regarding the toxic effects the FDA and Chicago Tribune comment on.  The

diarrhea and pancreas problems reported occurred during an UP/DOWN study to

determine the LD-50 of OSR, that is “what amount of OSR would cause 50% of the

test animals to die?â€.  Problem was that during the experimentation, even to

reach the 5 grams/kg body weight they finally achieved, the researchers had to

give the OSR (dissolved in corn oil) at three different times during the day. 

Even then the test animals showed no weight loss or ataxia or other signs of

toxicity except diarrhea and a pancreas abnormality.  They were giving these

animals massive doses (e.g. 1,000 to 5,000 times the recommended level for

humans) trying to kill them.  Almost all supplemental materials would cause

some problems at these levels and the LD-50 of OSR (decided to be greater than 5

g/kg) is considerably below the LD-50 of some commonly used supplemental

compounds used today. 

For example, a 220 lb (100 kg) person would have to take 500 grams/day or 5,000

OSR capsules/day to reach the 5 g/kg body weight level.  We recommend 1 capsule

or 0.1 gram/day level usage (i.e. 100mg) which is 5,000 times below the 5

gram/kg level in this example.  When the long term study was done and the

maximum amount tested was 1 gram/kg body weight the diarrhea and pancreas issues

disappeared.  At 1 gram/kg a 220 lb person would have to take 1,000

capsules/day to reach a level where no toxic effects were noted.  In it’s

initial letter responding to our Premarket Notification the FDA did not mention

these test animal toxicity studies as being of any concern.  I don’t know

what changed their minds to make them go back and review this, but their review

and the comments in this recent letter do not reflect a concern I would agree

with.

 

Also, OSR has never been promoted by CTI Science as a treatment for any specific

disease and FDA disclaimers are on every package.

 

I would point out that the FDA warning letter was not based on any reported

adverse effect.  Since CTI Science has been selling OSR (about 2 years) we have

not had one severe adverse effect reported to our FDA based adverse effect

reporting system.  We have had many very positive responses from physicians and

parents regarding the use of OSR.  However, the fact is that I have to obey the

FDA directive or risk damage to my co-workers as well as myself, and/or spend

the funds to legally counter the FDA decision.  What to do is under study. 

But from the above, you can see why I strongly believe that OSR is a dietary

supplement by FDA criteria and that it is without detectable toxicity at the

levels recommended.

 

Boyd E. Haley, PhD

________________________________

From: Sloan <Sloan_smith@...>

Sent: Fri, June 25, 2010 5:17:11 PM

Subject: Re: OSR#1 is not a dietary supplement but a toxic, unapproved

drug with serious pote

 

Sadly, this is one of the supplements my son was on. Sold to us a mild mild

chelator for his heavy metal load. $450.00

>

> latimes.com/news/health/sns-health-illegal-autism-therapy,0,747838.story

>

> latimes.com

> FDA: Autism 'Therapy' Illegal

> OSR#1 is not a dietary supplement but a toxic, unapproved drug with serious

potential side effects, the U.S. Food and Drug Administration warns.

> Trine Tsouderos

>

> Tribune reporter

>

> 5:18 PM PDT, June 23, 2010

>

> Advertisement

>

> A product promoted to parents of children with autism is not a harmless

dietary supplement, as claimed, but a toxic unapproved drug that lacks adequate

warnings about potential side effects, including hair loss and abnormalities of

the pancreas, the U.S. Food and Drug Administration has warned in a letter to

its maker.

>

> The FDA's June 17 letter to Boyd Haley, a retired Kentucky chemist and hero to

the autism recovery movement, details five violations of the Federal Food, Drug

and Cosmetic Act related to his product, OSR#1. Failing to correct such

violations can result in fines, seizure of products and even criminal

prosecution.

>

> The Tribune in January reported that the compound, sold as OSR#1, had been

developed to treat mining wastewater, and that it had not undergone rigorous

testing to ensure it is safe and effective. The report was part of an

investigation into unproven autism therapies offered by health providers who say

they can reverse the disorder.

>

> Haley did not reply to repeated requests for an interview Wednesday. An FDA

spokeswoman said the agency has not received any communication from Haley, who

has 15 working days from the date of the letter to respond.

>

> Last year, Haley told the Tribune: " I am not breaking any law. … We are

being very, very careful. "

>

> The Web site for Haley's company, Lexington, Ky.-based CTI Science, on

Wednesday was still promoting OSR#1 as " a toxicity free, lipid soluble

antioxidant dietary supplement, " and a reporter was able to order 30

100-milligram capsules of OSR#1 for $60 through an online pharmacy.

>

> In the interview last year, Haley called the product " a food " that is " totally

without toxicity. " Haley said the compound had been tested on rats, and a food

safety study was conducted on 10 people. Asked to provide documentation of the

research, he stopped communicating with the Tribune.

>

> The FDA letter lists side effects recorded during Haley's animal studies:

" soiling of the anogenital area, alopecia (hair loss) on the lower trunk, back

and legs, a dark substance on lower trunk and anogenital area, abnormalities of

the pancreas " and a rapid increase in normal cells contained in the lymph nodes.

>

> " It would be hard to imagine anything worse, " said Ellen Silbergeld, an expert

in environmental health who is studying mercury and autism at s Hopkins

University's Bloomberg School of Public Health. " An industrial chemical known to

be toxic — his own incomplete testing indicates it is toxic. It has no record

of any therapeutic aspect of it, and it is being marketed for use in children. "

>

> OSR#1 has been promoted on autism Web sites including Age of Autism, where

Managing Editor Kim Stagliano wrote of sprinkling the white powder on her three

daughters' breakfast sandwiches and orange juice. " We've seen some nice 'Wows!'

from OSR, " she wrote.

>

> In an e-mail, Stagliano wrote that she continues to support Haley, a regular

speaker at autism recovery conferences. " Having met Dr. Haley at conferences,

including Autism One in Chicago last month, I continue to trust his science, "

she wrote on Wednesday. " I'm sure CTI Science will address the letter

appropriately. "

>

> Pharmacologist Dr. Arthur Grollman, director of the Laboratory for Chemical

Biology at State University of New York at Stony Brook, said it is clear from

the product's chemical structure that it is 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 on the scientifically unfounded idea that their

disorder is linked to toxic metals.

>

> 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.

>

> The magazine Medical Veritas in 2006 reported that Haley said he was

interested in developing better chelators for people. " We've made compounds that

.... work tremendously " in a test tube, he was quoted as saying. " 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., records show. Less than a month later, he

notified the FDA he would be introducing the compound as a new dietary

ingredient, a designation rejected by the FDA in its recent letter.

>

> " Because OSR#1 does not bear or contain a dietary ingredient as defined (by

the food and drug act), this product does not qualify as a dietary supplement, "

the letter states.

>

> Instead, according to the letter, it is a new drug. Winning FDA approval

requires proof of safety and efficacy through clinical trials, a process that

can cost hundreds of millions of dollars and take many years.

>

> " Anything might be a cure for anything else, but the odds are it will do

nothing and it might very well be toxic, " said Mailman, a

neuropharmacologist at Penn State University. " That is why drug discovery and

development is so expensive. "

>

> Silbergeld said the product represents a clear example of endangerment of

public health and that the FDA should stop CTI Science from selling it

immediately. She drew a comparison to a city's drinking water system: If

contamination is found, she said, " they turn off the pumps. "

>

> " They don't have to engage in a long discussion with you, " Silbergeld said.

" It would be hard to imagine a more clear example of immediate endangerment of

public health. Turn off the pump. "

>

> Copyright © 2010, Chicago Tribune

>

[Guest guest]

sorry for the mis-spellings:

their child and think.

Its a decision each parent must make.

Kavita

The article by the Chicago Tribune and the warning letter from the FDA are

fueled by a misconception.  The chemical name of OSR#1 is

N1N3-bis-(2-mercaptoethyl)isophthalamide which makes it sound to many like an

exceptionally complex chemical with no natural components.  However, looking at

the structure of OSR it is easily seen that it contains a benzoate group (found

in cranberries) and two cystamines (a metabolite of cysteine and found in all

mammalian cells and on the terminal end of Coenzyme-A). The coupling of

cystamine to benzoate is through the same type of amide linkage found in

connecting amino acids to produce protein.

 

The FDA description of a dietary supplement as extracted from their letter is:

To be a dietary supplement, a product must, among other things, " bear [ ] or

contain [ ] one or more...dietary ingredients " as defined in section 20 I (11)(

I) of the Act, 21 U.S.c.§ 321 (ff)( I). Section 20 1(11)( 1) or the Act defines

" dietary ingredient " as a vitamin, mineral, amino acid, herb or other botanical,

or dietary substance for use by man to supplement the diet by increasing the

total dietary intake. or a concentrate, metabolite, constituent, extract or

combination of any dietary ingredient from the preceding categories.   Using

this description it is obvious to a biochemist that OSR#1 bears and contains two

dietary ingredients.  It appears as if the chemical name (which we had to place

on the label) has confused this issue.  Hopefully this can be cleared up.

 

Regarding the toxic effects the FDA and Chicago Tribune comment on.  The

diarrhea and pancreas problems reported occurred during an UP/DOWN study to

determine the LD-50 of OSR, that is “what amount of OSR would cause 50% of the

test animals to die?â€.  Problem was that during the experimentation, even to

reach the 5 grams/kg body weight they finally achieved, the researchers had to

give the OSR (dissolved in corn oil) at three different times during the day. 

Even then the test animals showed no weight loss or ataxia or other signs of

toxicity except diarrhea and a pancreas abnormality.  They were giving these

animals massive doses (e.g. 1,000 to 5,000 times the recommended level for

humans) trying to kill them.  Almost all supplemental materials would cause

some problems at these levels and the LD-50 of OSR (decided to be greater than 5

g/kg) is considerably below the LD-50 of some commonly used supplemental

compounds used today. 

For example, a 220 lb (100 kg) person would have to take 500 grams/day or 5,000

OSR capsules/day to reach the 5 g/kg body weight level.  We recommend 1 capsule

or 0.1 gram/day level usage (i.e. 100mg) which is 5,000 times below the 5

gram/kg level in this example.  When the long term study was done and the

maximum amount tested was 1 gram/kg body weight the diarrhea and pancreas issues

disappeared.  At 1 gram/kg a 220 lb person would have to take 1,000

capsules/day to reach a level where no toxic effects were noted.  In it’s

initial letter responding to our Premarket Notification the FDA did not mention

these test animal toxicity studies as being of any concern.  I don’t know

what changed their minds to make them go back and review this, but their review

and the comments in this recent letter do not reflect a concern I would agree

with.

 

Also, OSR has never been promoted by CTI Science as a treatment for any specific

disease and FDA disclaimers are on every package.

 

I would point out that the FDA warning letter was not based on any reported

adverse effect.  Since CTI Science has been selling OSR (about 2 years) we have

not had one severe adverse effect reported to our FDA based adverse effect

reporting system.  We have had many very positive responses from physicians and

parents regarding the use of OSR.  However, the fact is that I have to obey the

FDA directive or risk damage to my co-workers as well as myself, and/or spend

the funds to legally counter the FDA decision.  What to do is under study. 

But from the above, you can see why I strongly believe that OSR is a dietary

supplement by FDA criteria and that it is without detectable toxicity at the

levels recommended.

 

Boyd E. Haley, PhD

________________________________

From: Sloan <Sloan_smith@...>

Sent: Fri, June 25, 2010 5:17:11 PM

Subject: Re: OSR#1 is not a dietary supplement but a toxic, unapproved

drug with serious pote

 

Sadly, this is one of the supplements my son was on. Sold to us a mild mild

chelator for his heavy metal load. $450.00

>

> latimes.com/news/health/sns-health-illegal-autism-therapy,0,747838.story

>

> latimes.com

> FDA: Autism 'Therapy' Illegal

> OSR#1 is not a dietary supplement but a toxic, unapproved drug with serious

potential side effects, the U.S. Food and Drug Administration warns.

> Trine Tsouderos

>

> Tribune reporter

>

> 5:18 PM PDT, June 23, 2010

>

> Advertisement

>

> A product promoted to parents of children with autism is not a harmless

dietary supplement, as claimed, but a toxic unapproved drug that lacks adequate

warnings about potential side effects, including hair loss and abnormalities of

the pancreas, the U.S. Food and Drug Administration has warned in a letter to

its maker.

>

> The FDA's June 17 letter to Boyd Haley, a retired Kentucky chemist and hero to

the autism recovery movement, details five violations of the Federal Food, Drug

and Cosmetic Act related to his product, OSR#1. Failing to correct such

violations can result in fines, seizure of products and even criminal

prosecution.

>

> The Tribune in January reported that the compound, sold as OSR#1, had been

developed to treat mining wastewater, and that it had not undergone rigorous

testing to ensure it is safe and effective. The report was part of an

investigation into unproven autism therapies offered by health providers who say

they can reverse the disorder.

>

> Haley did not reply to repeated requests for an interview Wednesday. An FDA

spokeswoman said the agency has not received any communication from Haley, who

has 15 working days from the date of the letter to respond.

>

> Last year, Haley told the Tribune: " I am not breaking any law. … We are

being very, very careful. "

>

> The Web site for Haley's company, Lexington, Ky.-based CTI Science, on

Wednesday was still promoting OSR#1 as " a toxicity free, lipid soluble

antioxidant dietary supplement, " and a reporter was able to order 30

100-milligram capsules of OSR#1 for $60 through an online pharmacy.

>

> In the interview last year, Haley called the product " a food " that is " totally

without toxicity. " Haley said the compound had been tested on rats, and a food

safety study was conducted on 10 people. Asked to provide documentation of the

research, he stopped communicating with the Tribune.

>

> The FDA letter lists side effects recorded during Haley's animal studies:

" soiling of the anogenital area, alopecia (hair loss) on the lower trunk, back

and legs, a dark substance on lower trunk and anogenital area, abnormalities of

the pancreas " and a rapid increase in normal cells contained in the lymph nodes.

>

> " It would be hard to imagine anything worse, " said Ellen Silbergeld, an expert

in environmental health who is studying mercury and autism at s Hopkins

University's Bloomberg School of Public Health. " An industrial chemical known to

be toxic — his own incomplete testing indicates it is toxic. It has no record

of any therapeutic aspect of it, and it is being marketed for use in children. "

>

> OSR#1 has been promoted on autism Web sites including Age of Autism, where

Managing Editor Kim Stagliano wrote of sprinkling the white powder on her three

daughters' breakfast sandwiches and orange juice. " We've seen some nice 'Wows!'

from OSR, " she wrote.

>

> In an e-mail, Stagliano wrote that she continues to support Haley, a regular

speaker at autism recovery conferences. " Having met Dr. Haley at conferences,

including Autism One in Chicago last month, I continue to trust his science, "

she wrote on Wednesday. " I'm sure CTI Science will address the letter

appropriately. "

>

> Pharmacologist Dr. Arthur Grollman, director of the Laboratory for Chemical

Biology at State University of New York at Stony Brook, said it is clear from

the product's chemical structure that it is 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 on the scientifically unfounded idea that their

disorder is linked to toxic metals.

>

> 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.

>

> The magazine Medical Veritas in 2006 reported that Haley said he was

interested in developing better chelators for people. " We've made compounds that

.... work tremendously " in a test tube, he was quoted as saying. " 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., records show. Less than a month later, he

notified the FDA he would be introducing the compound as a new dietary

ingredient, a designation rejected by the FDA in its recent letter.

>

> " Because OSR#1 does not bear or contain a dietary ingredient as defined (by

the food and drug act), this product does not qualify as a dietary supplement, "

the letter states.

>

> Instead, according to the letter, it is a new drug. Winning FDA approval

requires proof of safety and efficacy through clinical trials, a process that

can cost hundreds of millions of dollars and take many years.

>

> " Anything might be a cure for anything else, but the odds are it will do

nothing and it might very well be toxic, " said Mailman, a

neuropharmacologist at Penn State University. " That is why drug discovery and

development is so expensive. "

>

> Silbergeld said the product represents a clear example of endangerment of

public health and that the FDA should stop CTI Science from selling it

immediately. She drew a comparison to a city's drinking water system: If

contamination is found, she said, " they turn off the pumps. "

>

> " They don't have to engage in a long discussion with you, " Silbergeld said.

" It would be hard to imagine a more clear example of immediate endangerment of

public health. Turn off the pump. "

>

> Copyright © 2010, Chicago Tribune

>

[Guest guest]

>

> that must be for a bulk purchase a person I know buys it for under £60 a

> month, and that is including import taxes shipping etc...

>

>

>

>

>

>

>>> > >

>>> > > latimes.com/news/health/sns-health-illegal-autism-therapy,0,747838.story

>>> > >

>>> > > latimes.com

>>> > > FDA: Autism 'Therapy' Illegal

>>> > > OSR#1 is not a dietary supplement but a toxic, unapproved drug with

>>> serious potential side effects, the U.S. Food and Drug Administration warns.

>>> > > Trine Tsouderos

>>> > >

>>> > > Tribune reporter

>>> > >

>>> > > 5:18 PM PDT, June 23, 2010

>>> > >

>>> > > Advertisement

>>> > >

>>> > > A product promoted to parents of children with autism is not a harmless

>>> dietary supplement, as claimed, but a toxic unapproved drug that lacks

>>> adequate warnings about potential side effects, including hair loss and

>>> abnormalities of the pancreas, the U.S. Food and Drug Administration has

>>> warned in a letter to its maker.

>>> > >

>>> > > The FDA's June 17 letter to Boyd Haley, a retired Kentucky chemist and

>>> hero to the autism recovery movement, details five violations of the Federal

>>> Food, Drug and Cosmetic Act related to his product, OSR#1. Failing to

>>> correct such violations can result in fines, seizure of products and even

>>> criminal prosecution.

>>> > >

>>> > > The Tribune in January reported that the compound, sold as OSR#1, had

>>> been developed to treat mining wastewater, and that it had not undergone

>>> rigorous testing to ensure it is safe and effective. The report was part of

>>> an investigation into unproven autism therapies offered by health providers

>>> who say they can reverse the disorder.

>>> > >

>>> > > Haley did not reply to repeated requests for an interview Wednesday. An

>>> FDA spokeswoman said the agency has not received any communication from

>>> Haley, who has 15 working days from the date of the letter to respond.

>>> > >

>>> > > Last year, Haley told the Tribune: " I am not breaking any law. … We are

>>> being very, very careful. "

>>> > >

>>> > > The Web site for Haley's company, Lexington, Ky.-based CTI Science, on

>>> Wednesday was still promoting OSR#1 as " a toxicity free, lipid soluble

>>> antioxidant dietary supplement, " and a reporter was able to order 30

>>> 100-milligram capsules of OSR#1 for $60 through an online pharmacy.

>>> > >

>>> > > In the interview last year, Haley called the product " a food " that is

>>> " totally without toxicity. " Haley said the compound had been tested on rats,

>>> and a food safety study was conducted on 10 people. Asked to provide

>>> documentation of the research, he stopped communicating with the Tribune.

>>> > >

>>> > > The FDA letter lists side effects recorded during Haley's animal

>>> studies: " soiling of the anogenital area, alopecia (hair loss) on the lower

>>> trunk, back and legs, a dark substance on lower trunk and anogenital area,

>>> abnormalities of the pancreas " and a rapid increase in normal cells

>>> contained in the lymph nodes.

>>> > >

>>> > > " It would be hard to imagine anything worse, " said Ellen Silbergeld, an

>>> expert in environmental health who is studying mercury and autism at s

>>> Hopkins University's Bloomberg School of Public Health. " An industrial

>>> chemical known to be toxic — his own incomplete testing indicates it is

>>> toxic. It has no record of any therapeutic aspect of it, and it is being

>>> marketed for use in children. "

>>> > >

>>> > > OSR#1 has been promoted on autism Web sites including Age of Autism,

>>> where Managing Editor Kim Stagliano wrote of sprinkling the white powder on

>>> her three daughters' breakfast sandwiches and orange juice. " We've seen some

>>> nice 'Wows!' from OSR, " she wrote.

>>> > >

>>> > > In an e-mail, Stagliano wrote that she continues to support Haley, a

>>> regular speaker at autism recovery conferences. " Having met Dr. Haley at

>>> conferences, including Autism One in Chicago last month, I continue to trust

>>> his science, " she wrote on Wednesday. " I'm sure CTI Science will address the

>>> letter appropriately. "

>>> > >

>>> > > Pharmacologist Dr. Arthur Grollman, director of the Laboratory for

>>> Chemical Biology at State University of New York at Stony Brook, said it is

>>> clear from the product's chemical structure that it is 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 on the scientifically unfounded idea that

>>> their disorder is linked to toxic metals.

>>> > >

>>> > > 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.

>>> > >

>>> > > The magazine Medical Veritas in 2006 reported that Haley said he was

>>> interested in developing better chelators for people. " We've made compounds

>>> that ... work tremendously " in a test tube, he was quoted as saying.

>>> " 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., records show. Less than a month

>>> later, he notified the FDA he would be introducing the compound as a new

>>> dietary ingredient, a designation rejected by the FDA in its recent letter.

>>> > >

>>> > > " Because OSR#1 does not bear or contain a dietary ingredient as defined

>>> (by the food and drug act), this product does not qualify as a dietary

>>> supplement, " the letter states.

>>> > >

>>> > > Instead, according to the letter, it is a new drug. Winning FDA approval

>>> requires proof of safety and efficacy through clinical trials, a process

>>> that can cost hundreds of millions of dollars and take many years.

>>> > >

>>> > > " Anything might be a cure for anything else, but the odds are it will do

>>> nothing and it might very well be toxic, " said Mailman, a

>>> neuropharmacologist at Penn State University. " That is why drug discovery

>>> and development is so expensive. "

>>> > >

>>> > > Silbergeld said the product represents a clear example of endangerment

>>> of public health and that the FDA should stop CTI Science from selling it

>>> immediately. She drew a comparison to a city's drinking water system: If

>>> contamination is found, she said, " they turn off the pumps. "

>>> > >

>>> > > " They don't have to engage in a long discussion with you, " Silbergeld

>>> said. " It would be hard to imagine a more clear example of immediate

>>> endangerment of public health. Turn off the pump. "

>>> > >

>>> > > , Chicago Tribune

>>> > >

>> >We did the vitamin & chelation( very little) thinking it was metals You

>> desperatly want to help your child get better. Our child got only sicker I

>> thank God we are doing what is right for him now. I agree with Sloan it is

>> the Wild West out there.

> Carole

>

>

>

>

>

[Guest guest]

>

>

> which guy have you spent your money on ???

>

>

> Natasa

>

>

>

> I am thinking about it, after all the money, time and anguish we spent on this

> guy.  I think we can all pass on a few lessons.

> 1. Don't use a doctor who has a commercial intrest in the supplements they

> sell

> 2. Use an actual doctor

> 3. If the practinioner has a side in an unrelated business (weight loss,

> suppresses memory syndrome, botox...) suspect that they are out for a quick

> buck

> 4.  If they have practiced in multiple states they have probably faced

> lawsuits and had their licenses revoked

> Pass it on.

>

>

>

>

> From: Sloan <Sloan_smith@... <mailto:Sloan_smith%40> >

> Subject: Re: OSR#1 is not a dietary supplement but a toxic, unapproved

> drug with serious pote

> <mailto:%40>

> Date: Friday, June 25, 2010, 5:17 PM

>

>  

>

> Sadly, this is one of the supplements my son was on. Sold to us a mild mild

> chelator for his heavy metal load. $450.00

>

>

>

>> >

>

>> > latimes.com/news/health/sns-health-illegal-autism-therapy,0,747838.story

>

>> >

>

>> > latimes.com

>

>> > FDA: Autism 'Therapy' Illegal

>

>> > OSR#1 is not a dietary supplement but a toxic, unapproved drug with serious

>> potential side effects, the U.S. Food and Drug Administration warns.

>

>> > Trine Tsouderos

>

>> >

>

>> > Tribune reporter

>

>> >

>

>> > 5:18 PM PDT, June 23, 2010

>

>> >

>

>> > Advertisement

>

>> >

>

>> > A product promoted to parents of children with autism is not a harmless

>> dietary supplement, as claimed, but a toxic unapproved drug that lacks

>> adequate warnings about potential side effects, including hair loss and

>> abnormalities of the pancreas, the U.S. Food and Drug Administration has

>> warned in a letter to its maker.

>

>> >

>

>> > The FDA's June 17 letter to Boyd Haley, a retired Kentucky chemist and hero

>> to the autism recovery movement, details five violations of the Federal Food,

>> Drug and Cosmetic Act related to his product, OSR#1. Failing to correct such

>> violations can result in fines, seizure of products and even criminal

>> prosecution.

>

>> >

>

>> > The Tribune in January reported that the compound, sold as OSR#1, had been

>> developed to treat mining wastewater, and that it had not undergone rigorous

>> testing to ensure it is safe and effective. The report was part of an

>> investigation into unproven autism therapies offered by health providers who

>> say they can reverse the disorder.

>

>> >

>

>> > Haley did not reply to repeated requests for an interview Wednesday. An FDA

>> spokeswoman said the agency has not received any communication from Haley,

>> who has 15 working days from the date of the letter to respond.

>

>> >

>

>> > Last year, Haley told the Tribune: " I am not breaking any law. Š We are

>> being very, very careful. "

>

>> >

>

>> > The Web site for Haley's company, Lexington, Ky.-based CTI Science, on

>> Wednesday was still promoting OSR#1 as " a toxicity free, lipid soluble

>> antioxidant dietary supplement, " and a reporter was able to order 30

>> 100-milligram capsules of OSR#1 for $60 through an online pharmacy.

>

>> >

>

>> > In the interview last year, Haley called the product " a food " that is

>> " totally without toxicity. " Haley said the compound had been tested on rats,

>> and a food safety study was conducted on 10 people. Asked to provide

>> documentation of the research, he stopped communicating with the Tribune.

>

>> >

>

>> > The FDA letter lists side effects recorded during Haley's animal studies:

>> " soiling of the anogenital area, alopecia (hair loss) on the lower trunk,

>> back and legs, a dark substance on lower trunk and anogenital area,

>> abnormalities of the pancreas " and a rapid increase in normal cells contained

>> in the lymph nodes.

>

>> >

>

>> > " It would be hard to imagine anything worse, " said Ellen Silbergeld, an

>> expert in environmental health who is studying mercury and autism at s

>> Hopkins University's Bloomberg School of Public Health. " An industrial

>> chemical known to be toxic ‹ his own incomplete testing indicates it is

>> toxic. It has no record of any therapeutic aspect of it, and it is being

>> marketed for use in children. "

>

>> >

>

>> > OSR#1 has been promoted on autism Web sites including Age of Autism, where

>> Managing Editor Kim Stagliano wrote of sprinkling the white powder on her

>> three daughters' breakfast sandwiches and orange juice. " We've seen some nice

>> 'Wows!' from OSR, " she wrote.

>

>> >

>

>> > In an e-mail, Stagliano wrote that she continues to support Haley, a

>> regular speaker at autism recovery conferences. " Having met Dr. Haley at

>> conferences, including Autism One in Chicago last month, I continue to trust

>> his science, " she wrote on Wednesday. " I'm sure CTI Science will address the

>> letter appropriately. "

>

>> >

>

>> > Pharmacologist Dr. Arthur Grollman, director of the Laboratory for Chemical

>> Biology at State University of New York at Stony Brook, said it is clear from

>> the product's chemical structure that it is 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 on the scientifically unfounded idea that their

>> disorder is linked to toxic metals.

>

>> >

>

>> > 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.

>

>> >

>

>> > The magazine Medical Veritas in 2006 reported that Haley said he was

>> interested in developing better chelators for people. " We've made compounds

>> that ... work tremendously " in a test tube, he was quoted as saying.

>> " 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., records show. Less than a month later,

>> he notified the FDA he would be introducing the compound as a new dietary

>> ingredient, a designation rejected by the FDA in its recent letter.

>

>> >

>

>> > " Because OSR#1 does not bear or contain a dietary ingredient as defined (by

>> the food and drug act), this product does not qualify as a dietary

>> supplement, " the letter states.

>

>> >

>

>> > Instead, according to the letter, it is a new drug. Winning FDA approval

>> requires proof of safety and efficacy through clinical trials, a process that

>> can cost hundreds of millions of dollars and take many years.

>

>> >

>

>> > " Anything might be a cure for anything else, but the odds are it will do

>> nothing and it might very well be toxic, " said Mailman, a

>> neuropharmacologist at Penn State University. " That is why drug discovery and

>> development is so expensive. "

>

>> >

>

>> > Silbergeld said the product represents a clear example of endangerment of

>> public health and that the FDA should stop CTI Science from selling it

>> immediately. She drew a comparison to a city's drinking water system: If

>> contamination is found, she said, " they turn off the pumps. "

>

>> >

>

>> > " They don't have to engage in a long discussion with you, " Silbergeld said.

>> " It would be hard to imagine a more clear example of immediate endangerment

>> of public health. Turn off the pump. "

>

>> >

>

>> > , Chicago Tribune

>

>> >

>

>

[Guest guest]

Warren Levin outside of DC. He is a Lyme specialist and our experience with him

did not turn out well.

Sent from my iPhone

On Jun 28, 2010, at 3:05 PM, Neno/Natasa <neno@...> wrote:

>

>

> which guy have you spent your money on ???

>

>

> Natasa

>

>

>

> I am thinking about it, after all the money, time and anguish we spent on this

> guy. I think we can all pass on a few lessons.

> 1. Don't use a doctor who has a commercial intrest in the supplements they

> sell

> 2. Use an actual doctor

> 3. If the practinioner has a side in an unrelated business (weight loss,

> suppresses memory syndrome, botox...) suspect that they are out for a quick

> buck

> 4. If they have practiced in multiple states they have probably faced

> lawsuits and had their licenses revoked

> Pass it on.

>

>

>

>

> From: Sloan <Sloan_smith@... <mailto:Sloan_smith%40> >

> Subject: Re: OSR#1 is not a dietary supplement but a toxic, unapproved

> drug with serious pote

> <mailto:%40>

> Date: Friday, June 25, 2010, 5:17 PM

>

>

>

> Sadly, this is one of the supplements my son was on. Sold to us a mild mild

> chelator for his heavy metal load. $450.00

>

>

>

>> >

>

>> > latimes.com/news/health/sns-health-illegal-autism-therapy,0,747838.story

>

>> >

>

>> > latimes.com

>

>> > FDA: Autism 'Therapy' Illegal

>

>> > OSR#1 is not a dietary supplement but a toxic, unapproved drug with serious

>> potential side effects, the U.S. Food and Drug Administration warns.

>

>> > Trine Tsouderos

>

>> >

>

>> > Tribune reporter

>

>> >

>

>> > 5:18 PM PDT, June 23, 2010

>

>> >

>

>> > Advertisement

>

>> >

>

>> > A product promoted to parents of children with autism is not a harmless

>> dietary supplement, as claimed, but a toxic unapproved drug that lacks

>> adequate warnings about potential side effects, including hair loss and

>> abnormalities of the pancreas, the U.S. Food and Drug Administration has

>> warned in a letter to its maker.

>

>> >

>

>> > The FDA's June 17 letter to Boyd Haley, a retired Kentucky chemist and hero

>> to the autism recovery movement, details five violations of the Federal Food,

>> Drug and Cosmetic Act related to his product, OSR#1. Failing to correct such

>> violations can result in fines, seizure of products and even criminal

>> prosecution.

>

>> >

>

>> > The Tribune in January reported that the compound, sold as OSR#1, had been

>> developed to treat mining wastewater, and that it had not undergone rigorous

>> testing to ensure it is safe and effective. The report was part of an

>> investigation into unproven autism therapies offered by health providers who

>> say they can reverse the disorder.

>

>> >

>

>> > Haley did not reply to repeated requests for an interview Wednesday. An FDA

>> spokeswoman said the agency has not received any communication from Haley,

>> who has 15 working days from the date of the letter to respond.

>

>> >

>

>> > Last year, Haley told the Tribune: " I am not breaking any law. … We are

>> being very, very careful. "

>

>> >

>

>> > The Web site for Haley's company, Lexington, Ky.-based CTI Science, on

>> Wednesday was still promoting OSR#1 as " a toxicity free, lipid soluble

>> antioxidant dietary supplement, " and a reporter was able to order 30

>> 100-milligram capsules of OSR#1 for $60 through an online pharmacy.

>

>> >

>

>> > In the interview last year, Haley called the product " a food " that is

>> " totally without toxicity. " Haley said the compound had been tested on rats,

>> and a food safety study was conducted on 10 people. Asked to provide

>> documentation of the research, he stopped communicating with the Tribune.

>

>> >

>

>> > The FDA letter lists side effects recorded during Haley's animal studies:

>> " soiling of the anogenital area, alopecia (hair loss) on the lower trunk,

>> back and legs, a dark substance on lower trunk and anogenital area,

>> abnormalities of the pancreas " and a rapid increase in normal cells contained

>> in the lymph nodes.

>

>> >

>

>> > " It would be hard to imagine anything worse, " said Ellen Silbergeld, an

>> expert in environmental health who is studying mercury and autism at s

>> Hopkins University's Bloomberg School of Public Health. " An industrial

>> chemical known to be toxic — his own incomplete testing indicates it is

>> toxic. It has no record of any therapeutic aspect of it, and it is being

>> marketed for use in children. "

>

>> >

>

>> > OSR#1 has been promoted on autism Web sites including Age of Autism, where

>> Managing Editor Kim Stagliano wrote of sprinkling the white powder on her

>> three daughters' breakfast sandwiches and orange juice. " We've seen some nice

>> 'Wows!' from OSR, " she wrote.

>

>> >

>

>> > In an e-mail, Stagliano wrote that she continues to support Haley, a

>> regular speaker at autism recovery conferences. " Having met Dr. Haley at

>> conferences, including Autism One in Chicago last month, I continue to trust

>> his science, " she wrote on Wednesday. " I'm sure CTI Science will address the

>> letter appropriately. "

>

>> >

>

>> > Pharmacologist Dr. Arthur Grollman, director of the Laboratory for Chemical

>> Biology at State University of New York at Stony Brook, said it is clear from

>> the product's chemical structure that it is 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 on the scientifically unfounded idea that their

>> disorder is linked to toxic metals.

>

>> >

>

>> > 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.

>

>> >

>

>> > The magazine Medical Veritas in 2006 reported that Haley said he was

>> interested in developing better chelators for people. " We've made compounds

>> that ... work tremendously " in a test tube, he was quoted as saying.

>> " 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., records show. Less than a month later,

>> he notified the FDA he would be introducing the compound as a new dietary

>> ingredient, a designation rejected by the FDA in its recent letter.

>

>> >

>

>> > " Because OSR#1 does not bear or contain a dietary ingredient as defined (by

>> the food and drug act), this product does not qualify as a dietary

>> supplement, " the letter states.

>

>> >

>

>> > Instead, according to the letter, it is a new drug. Winning FDA approval

>> requires proof of safety and efficacy through clinical trials, a process that

>> can cost hundreds of millions of dollars and take many years.

>

>> >

>

>> > " Anything might be a cure for anything else, but the odds are it will do

>> nothing and it might very well be toxic, " said Mailman, a

>> neuropharmacologist at Penn State University. " That is why drug discovery and

>> development is so expensive. "

>

>> >

>

>> > Silbergeld said the product represents a clear example of endangerment of

>> public health and that the FDA should stop CTI Science from selling it

>> immediately. She drew a comparison to a city's drinking water system: If

>> contamination is found, she said, " they turn off the pumps. "

>

>> >

>

>> > " They don't have to engage in a long discussion with you, " Silbergeld said.

>> " It would be hard to imagine a more clear example of immediate endangerment

>> of public health. Turn off the pump. "

>

>> >

>

>> > Copyright © 2010, Chicago Tribune

>

>> >

>

>