CSR1: Treat wastewater, and give to Autistics! No, says FDA.

[SirNitram]

Link

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 Johns 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 Richard 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."

I get that we aren't 'people' in the eye of these people. But do they treat their pets like this?

[Morilore]

Is there any other condition that doctors and lay people try to address so recklessly?

[Simon_Jester]

Yes.

You've got people trying to cure cancer by going on weird diets, for instance.

[LadyTevar]

Of course an autistic child isn't -human-. Human beings are able to talk, think, and converse with their parents, not sit in the floor throwing wild fits that harm themselves and/or others. Even a dog can be taught not to pee on the carpet.
[/sarcasm off]

I wonder how many of these kids will die before the parents are charged with willful poisoning. Hell, the CPS should be TAKING these kids away from them!

[Serafina]

I hope that none of the parents actually do this willingly!
Of course, i would not be surprised if they did - shocked and disgusted, but i would not be surprised. Unfortunately.

[Simon_Jester]

I suspect that mostly they don't understand what they are doing, because they have no ability to understand this stuff beyond "man in lab coat tells me X!" Snake oil salesman prey on the stupid and the desperate, or in this case the children of the stupid and the desperate.

[Ilya Muromets]

As one of my younger brothers is autistic, I find this especially disgusting. I really hope the fuckers don't get off and that they get arrested for this.

And to make an already abhorrent situation worse, you just know some anti-science idiot is gonna latch on to this as proof that science is evil.

[SirNitram]

I hope that none of the parents actually do this willingly!
Of course, i would not be surprised if they did - shocked and disgusted, but i would not be surprised. Unfortunately.

The vast majority are not willing, no. Because Adults With Autism Are Not Allowed. It means you'd need to deal with all of us, in the world, in the workplace, etc. People would have to look full grown humans in the face and realize they are not some tabula rasa to quote the psychopath Lovaas who helped much of modern vaccine 'recovery' folks.

The majority are parents being led along because their children are different. And I suspect no small number are there because their babies are not quiet, self-managing little bundles of cute, but they can't be bothered. But.

And there's this whole setup for these people to get snapped up in snake oil and bullshit, headed by a pair of -CELEBRITIES-. It also nicely feeds into the anti-government paranoia with the anti-vaccine movement.

This drug.. This toxic chemical used for reducing mercery in mine-wastewater.. Is being sold because the Religion of Autism Recovery demands that mercurcy is always the problem, and it came from vaccines.

[MKSheppard]

I fail to see how this is even news. Someone is under investigation by the FDA for Quackery, not exactly earth shaking news.

It's not for nothing the American Cancer Society maintains a "Subcommittee on Alternative and Complementary Methods of Cancer Management" to find and root out Quackery.

[Losonti Tokash]

I fail to see how this is even news. Someone is under investigation by the FDA for Quackery, not exactly earth shaking news.

It's not for nothing the American Cancer Society maintains a "Subcommittee on Alternative and Complementary Methods of Cancer Management" to find and root out Quackery.

People tend to frown on lunatics poisoning children for profit. Just throwing that out there.

Anyway, what I think might be the worst part of the article is the mother that runs an autism website, who puts this crap into her children's food, and still says she trusts the crazy asshole that marketed this stuff.

[MKSheppard]

People tend to frown on lunatics poisoning children for profit. Just throwing that out there.

People also tend to frown just as harshly -- maybe more so -- on lunatics taking advantage of people with life threatening symptoms like cancer to make a quick buck.

But it still happens, despite the best efforts of the FDA; because they can always hide behind the "dietary supplement" dodge.

[LadyTevar]

But it still happens, despite the best efforts of the FDA; because they can always hide behind the "dietary supplement" dodge.

And that is what this quack is doing -- calling it a "dietary supplement' meant to remove the heavy metals (mercury). Because 'everybody knows' that Mercury in Vaccines are what causes Autism, right?

WRONG.
So they are poisoning kids, removing 'heavy metals' that aren't really there, with a 'dietary supplement' that isn't. What scares me is that woman is giving it to *all* her kids... but it doesn't say that all of them are autistic. She may be feeding this to her perfectly healthy kids, just from fears of Mercury Poisoning!

Yes, there's kids out there being poisoned to cure their cancer. It's called chemo and radiation treatment, on top of whatever quackery is being offered. However, those parents are frantically trying to save the life of their child, afraid of them dying horrible deaths.

Parents of Autistic children are afraid of LIFE with a child who can't grin at them and say 'Mommy'. If the child was Deaf, that's ok, there's treatments and schools and a normal life for them. Same if the child was blind. But an Autistic child, one at the far extreme? If it was politic to do so, those kids would be hustled off to a institution like the 'good ol days' and forgotten.

[Broomstick]

There are actually a fair number of parents who can't cope with deaf or blind or otherwise crippled kids, too. Sure, there's a point at which you can't ignore it, but I've known kids with vision problems who were denied glasses and berated for clumsiness and told to "snap out of it". Hard of hearing kids beaten for not responding to verbal commands. That sort of thing.

My Other Half was subjected to unproven experimental surgery that, at one point, almost cost him his right leg. Because it was so fucking important he'd be able to walk normally that it was worth risking life and limb, literally, to attain that goal. (He still has a severe limp. The result was a leg functioning less well than before)

There is so much pressure to produce perfect children, rather than children who will live happy, fulfilling if atypical lives.

[Invictus ChiKen]

Damn when I read the thread title I thought someone had opened a wastewater treatment facility and was giving a portion of the profit to help Autistics and the FDA was trying to ruin it.

This is worse than that... An I can agree with Broomstick, I had that issue when my dyslexia was first diagnosed. The constant pressure to be 'normal' when your not.

[Einhander Sn0m4n]

People tend to frown on lunatics poisoning children for profit. Just throwing that out there.

Yeah, like BP.

People also tend to frown just as harshly -- maybe more so -- on lunatics taking advantage of people with life threatening symptoms like cancer to make a quick buck.

But it still happens, despite the best efforts of the FDA; because they can always hide behind the "dietary supplement" dodge.

Whaaaaaaaat!?? Shep calling for *more* and actually *effective* government oversight and regulation?! But, that's COMMUNISM, comrade!

[Setesh]

Damn when I read the thread title I thought someone had opened a wastewater treatment facility and was giving a portion of the profit to help Autistics and the FDA was trying to ruin it.

This is worse than that... An I can agree with Broomstick, I had that issue when my dyslexia was first diagnosed. The constant pressure to be 'normal' when your not.

I think a pretty broad section of the membership here can testify to being screwed over in this manner in one form or another. Myself included.

On topic: The very worst part is that even if this was a safe treatment for mercury poisoning, it would be useless to treat autism as its mostly due to complex genetic factors, and defects in synapse formation. Environmental factors are claimed but with little evidence beyond an increased chance if the mother is exposed to birth defect causing chemicals. Making this not only bullshit but triple bullshit. It doesn't do whats advertised, what its suppose to do wouldn't work, and the source of the problem they're not fixing isn't real. I set this with 'bleeding' as a treatment.

The 'vaccines cause autism OMG' bullshit started because autistic behaviors tend to start around the same ages vaccinations do. But frankly holds as much water as the idea its caused by chemicals released from the plastic of a water bottle. And yes this was at one time claimed to be the cause of autism.

[PeZook]

Remember, people: Codex Alimentarius (A WHO initiative to introduce a standardized set of food regulations) is going to ruin the health of everyone by regulating dietary supplements!

The lies perpetrated every day by peddlers of "altenative medicine" are just incredible and mind-boggling. Equally incredible is the question of why people constantly believe them...