Guest guest Posted June 26, 2010 Report Share Posted June 26, 2010 Janelle and Natasa, I hope I did not offend you, though it sounds like I did. I totally disagree with the use of this product. This is the only place I can actually go and say it, everywhere else I get attacked for disagreeing. I have a right to my opinion, and it's just that, only my opinion. I agree about some of this, yes Trine would most definitely go after if it was on her radar. However, OSR is an industrial chemical and my point was that parents will readily give it to their children but think twice about giving a child tested medications. This does not make sense to me. We don't all have to agree about this. People should be able to say they don't agree with giving kids a treatment or not. I want all kids with autism to get better, I didn't even know this article was written by Trine, but I myself have questioned many autism treatments that parents pay so much money for and they could be hurting their children (like Dr. Eisenstein giving Lupron to children). There are many charletans that are stealing desperate parents' money (it happened to me way too many times) and when I saw that it was 450 dollars that seems very suspect to me. I respect Dr. Haley and I know he is a good guy but he is a chemist, not a doctor. But I don't like how Trine also manipulates the facts, which is exactly what she was doing. -Jen > > > >> > > > > >> > > > 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 > > > >> > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 26, 2010 Report Share Posted June 26, 2010 I agree, What I said may have angered some but in comparison to what has historically happened in this industry " ANYTHING " good or bad that has not been put through complete and transparent clinical trails should not be market to desperate parents as a miracle cure for autism, period. There have been dozens on FDA approved medication that have turned out to be dangerous in the long run and that is for meds that have been vigorously tested and put through trials. To give a kid an industrial chemical designed to treat toxic run off without appropriate testing is just wrong. To bypass the system by labeling it a food additive is criminal. We have a system in place to protect consumers and in this case critically ill children. It works and needs to be respected. If you disagree with the system, change it. Until then regardless of the good intentions, this is illegal and dangerous. I for one would not give it to my DOG! From: <jlhank80@...> Subject: Re: OSR#1 Date: Saturday, June 26, 2010, 10:03 AM  Janelle and Natasa, I hope I did not offend you, though it sounds like I did. I totally disagree with the use of this product. This is the only place I can actually go and say it, everywhere else I get attacked for disagreeing. I have a right to my opinion, and it's just that, only my opinion. I agree about some of this, yes Trine would most definitely go after if it was on her radar. However, OSR is an industrial chemical and my point was that parents will readily give it to their children but think twice about giving a child tested medications. This does not make sense to me. We don't all have to agree about this. People should be able to say they don't agree with giving kids a treatment or not. I want all kids with autism to get better, I didn't even know this article was written by Trine, but I myself have questioned many autism treatments that parents pay so much money for and they could be hurting their children (like Dr. Eisenstein giving Lupron to children). There are many charletans that are stealing desperate parents' money (it happened to me way too many times) and when I saw that it was 450 dollars that seems very suspect to me. I respect Dr. Haley and I know he is a good guy but he is a chemist, not a doctor. But I don't like how Trine also manipulates the facts, which is exactly what she was doing. -Jen > > > >> > > > > >> > > > 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 > > > >> > > > > > Quote Link to comment Share on other sites More sharing options...
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