FDA warns maker of alternative autism treatment
The U.S. Food and Drug Administration in June sent a warning letter to the maker of a product that was being used to treat symptoms of autism, the Chicago Tribune reported. The product, OSR#1, was being sold as a dietary supplement by a Kentucky company, but the FDA wrote that it was an unapproved drug with inadequately disclosed side effects. The company, CTI Science, was founded by Boyd Haley, Ph.D., an emeritus professor of chemistry at the University of Kentucky, who is well known in alternative autism treatment circles for his concern about mercury toxicity.
The June 17 letter said that failure to correct violations of the Federal Food, Drug and Cosmetic Act could result in legal action. In a July 12 op-ed in the Lexington, Ky. Herald-Leader, Haley defended the product’s composition, described his safety testing and wrote that his legal representative had contacted the FDA to resolve its concerns. In a July 22 communication to healthcare providers and pharmacies that had registered on the CTI Science Web site to dispense OSR#1, Boyd wrote that he had decided not to contest the FDA’s assertion that the product is a drug and opted to remove it from the market, as of July 29, until it could be re-offered with FDA approval.
Promotional materials say that OSR#1 is a toxicity-free, lipid-soluble antioxidant that helps maintain healthy glutathione levels by scavenging free radicals; they do not mention autism. “What led to the use of OSR#1 by doctors is the fact that autistic children suffer from oxidative stress,” Haley wrote in the Herald-Leader.
But its chemical makeup puts it among a group of chelators that University of Kentucky chemists developed originally to remove heavy metals from soil and mining effluent, according to the Tribune and one of its sources, Kathleen Seidel, M.L.S., of Peterborough, N.H. Seidel writes the blog Neurodiversity.com and has been following Haley since 2004. In July 2008, she read on message boards that Haley was planning to introduce a new chelator, which eventually morphed into a dietary supplement. (CTI Science used to be called Chelator Technologies, Inc.)
“This had every appearance of Boyd Haley attempting to do an end run around FDA regulations by marketing this substance as a dietary supplement until the FDA tells him to stop,” says Seidel, who has a college-age son with Asperger’s. “Yes, the regulatory system is flawed. Still, it doesn’t mean a small pharmaceutical manufacturer should be able to take shortcuts with drug development.”
The Web site Age of Autism endorsed OSR#1 in an April 2009 post. Editor Kim Stagliano, who lives in Connecticut and has three autistic daughters, described sprinkling the powder on her children’s morning juice and breakfast sandwiches with positive results. She declined an interview request.
A CTI Science registered provider, Mark Breiner, D.D.S., of Whole Body Dentistry in Trumbull, Conn., was not concerned about OSR#1’s history as an industrial chelator or the ethics of Haley testing his product himself. Breiner has prescribed it to about 100 patients with no adverse effects. He says lab tests show the product raises glutathione levels “tremendously.” He has not prescribed it for autism, but says it would make perfect sense to do so. In June 2009, he wrote in his practice newsletter that OSR originally meant Oxidative Stress Relief but was changed to Optimize, Strengthen and Rejuvenate.
“We’re just about out of it,” Breiner says. “It’s a shame to take away a product that could help people out. It’s not a toxic drug.” In contrast, a July 12 post on Neurodiversity.com includes a long list of side effects gleaned from online discussion groups.
While spirited comments on the Tribune articles have boomeranged around the blogosphere, Lisa Jo Rudy, M. Div., the About.com autism guide, hasn’t come across anyone who has tried OSR#1.
“It’s become a big to-do, yet honestly, it’s not really a commonly-used treatment,” says Rudy, who runs the site from her Falmouth, Mass. home and has a son diagnosed with PDD-NOS. She says the crux of the issue is that parents of autistic children feel marginalized by the medical establishment and will rally to defend a champion they feel is being attacked.
“Over time, a community of people has arisen who believe strongly that their kids’ autism was caused by a medical community willing to let it happen and further that the harm can be undone by medical and biomedical interventions, diet supplements, chelation and other things,” Rudy says. So when what appears to be a promising treatment is withdrawn, “there’s a feeling of conspiracy that the government and big pharma are deliberately trying to squelch potential cures for autism.”
Parents may want alternatives, but Seidel says they are spending many millions of dollars on unproven alternative treatments and supplements pushed by a small crew of doctors and therapists who exploit their belief in vaccine injury and other causation theories. CTI Science suggested retailing OSR#1 for $60 for a 30-day supply of 100 mg capsules and $180 for a 90-day supply of powder.
Science blogger Steven Novella, M.D., brings to the discussion his perspective as a neurologist at the Yale University School of Medicine, but is not involved in autism research. He is losing patience with the “mercury militia.”
“Using a chelating agent to treat autism is based on the premise that mercury toxicity causes autism. That, scientifically, is a dead issue,” Novella says. “If there were any relation between thimerosal and autism, we should have seen a dramatic effect on autism rates when thimerosal was removed from the vaccine schedule.”
He could understand parents feeling marginalized by the establishment 30 years ago when autism was neglected and stigmatized, but today autism is a highly recognized disorder that attracts significant funding for research and support services, he says.
“People who disagree are on the fringe, and their beliefs are based on anecdote and conspiracy theory, not evidence,” Novella adds.