Guest guest Posted June 25, 2010 Report Share Posted June 25, 2010 To share my family's experience, we used OSR#1 for more than a year with tremendous gains until our son recovered to the point we no longer needed this particular supplement. I've never heard a price tag of $450 for this supplement -- maybe that was for a large quantity. I personally paid $60/month for this particular supplement. ly, Boyd Haley is one of the good guys with our kids' interests truly at heart. He has gone out on a limb personally and professionally for our kids with this product but also with his tireless research and outspokenness on our children's behalf. I wish there were more of the good guys out there like him. In terms of the money he has made on this supplement, my understanding is that it is minimal at best. He came up with and formulated the supplement but has released all rights to this other company. He truly formulated it to help kids, not to make himself rich. Trine Tsouderos, on the other hand, seems to be trying to systematically go after the docs/researchers/parents in the autism community who are trying to make our children better. She has had several of these types of articles in the recent past that have gone against our community and those who are trying to help our community. Consider this reporter (journalist, not scientist) for what she is: a person who writes about how kids with autism don't really have more gut problems than other kids, etc. (Clearly she knows little about the actual issues related to autism). She is a food reporter turned " science " reporter who seems to have a bee in her bonnet for the people who are trying to recover kids with autism. My opinion is to take this article and any others she may write with a grain of salt. I say, ignore this article and any others she may write. Janelle 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 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 Inflammatory articles are usually written to defame the good that people are doing on the behalf of autistic children ( Dr Wakefield comes to mind )..yet the world is not flat, and the truth will come out; I believe the cascade has begun, and we must rally behind it, and the message is that our children are truly sick, and need/ deserve treatment.... 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 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 second that, Trine T is a scumbag, the only reason she has not vented > against and DrGoldberg so far is that she most likely does not know he > exists. She will viciously attack anything and anyone that helps our kids, > make no mistake about it. OSR was the big news in the DAN world, that is why > she went for it (i.e. she heard about it). > > She went after WPI and drMikovitz only a few weeks ago, but luckily did not > have much negative to say... > > this is what Hillary had to say on her and Chicago Tribune > ³quackbusting² and the level of journalism in general: > > http://oslersweb.com/blog.htm?post=710020 > > there is no way she will NOT attack viciously once she knows about it!!! > > I also second that about Boyd, definitely one of the good guys acting out of > best interests of our children, whether you agree with theories of > metals/chelation or not. > > Do think twice before taking sides here please guys > > Natasa > > > > > > > > To share my family's experience, we used OSR#1 for more than a year with > tremendous gains until our son recovered to the point we no longer > needed this particular supplement. I've never heard a price tag of $450 > for this supplement -- maybe that was for a large quantity. I > personally paid $60/month for this particular supplement. ly, > Boyd Haley is one of the good guys with our kids' interests truly at > heart. He has gone out on a limb personally and professionally for our > kids with this product but also with his tireless research and > outspokenness on our children's behalf. I wish there were more of the > good guys out there like him. In terms of the money he has made on this > supplement, my understanding is that it is minimal at best. He came up > with and formulated the supplement but has released all rights to this > other company. He truly formulated it to help kids, not to make > himself rich. > > Trine Tsouderos, on the other hand, seems to be trying to systematically > go after the docs/researchers/parents in the autism community who are > trying to make our children better. She has had several of these types > of articles in the recent past that have gone against our community and > those who are trying to help our community. Consider this reporter > (journalist, not scientist) for what she is: a person who writes about > how kids with autism don't really have more gut problems than other > kids, etc. (Clearly she knows little about the actual issues related to > autism). She is a food reporter turned " science " reporter who seems to > have a bee in her bonnet for the people who are trying to recover kids > with autism. My opinion is to take this article and any others she may > write with a grain of salt. I say, ignore this article and any others > she may write. > > > Janelle > > > > > 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 > > > >> > > >> > > 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 absolutely agree! When journalists are being " rewarded " for going the line that autism is genetic and there is no epidemic (us crazy parents are just looking for someone to blame but ourselves). That article she printed on Dr. Judy Mikovits made me sick. I can't believe she tried to diminish her and make her appear to be some fringe scientist. The only reason Dr. Mikovits is still going is because she has the XMRV prostate link that hurts grown up men and it looks like we have a positive XMRV paper on the horizon from the FDA and NIH. If there was no prostate link, I would not be surprised if the NIH and FDA could not find XMRV, just like the psychologists in England and the Netherlands.  Jill > > From: Sloan <Sloan_smith@... <mailto:Sloan_smith%40> > <mailto:Sloan_smith%40> > > Subject: 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 > > > >> > > >> > > 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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