Re: Bogus emails

[Guest guest]

Hello everyone-I just wanted to let all of you know that my email was hacked

into and it automatically sent out a bogus message from my email, with no

subject, that I never sent. Please disregard it.

Gayle

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

> unapproved drug with serious pote

> <mailto:%40>;

> <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

>

>

>

>> >

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>> >

> 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 C 2010, Chicago Tribune

>

>> >

>

>