OSR#1 Not A Dietary Supplement, Serious Side Affects Warns FDA
The Chicago Tribune is running a follow up story on the status of OSR#1, a drug that was peddled as a "cure" for Autism and a dietary supplement.Â It seems the FDA has looked into the "supplement", and found that it contains no dietary benefits, and instead is a powerful chelator, binding to heavy metals to remove from the system.Â That, in and of itself is dangerous, if chelation is not necessary, as the body requires heavy metals to survive.Â
When the Tribune investigated this drug last year, they specifically asked the company developing this substance, CTI Science Inc., for the research they claimed had proven the safety and efficacy of the product.Â The company stopped returning phone calls at that point.Â
But now the FDA has had a look at the research (on lab rats), and found that there were some side effects recorded:Â 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.Â
Ellen Silbergeld of Johns Hopkins University has warned against the substance, and Pharmacologist Dr. Arthur Grollman identified the substance as a powerful chelator that can be toxic if only normal amounts of heavy metals are found in the body.
The FDA has denied the labeling of this substance as a "dietary supplement" because it does not bear or contain a dietary ingredient.Â Therefore it is, in fact, a new drug, which requires proof of safety and efficacy through clinical trials.Â This process is very lengthy and expensive, as noted by Richard Mailman of Penn State University, and is that way for a reason.Â It needs to be proven safe, and reputable drug companies take the time and pains to make sure that is the case.Â It seems that CTI Science Inc. has failed to meet these standards.
I'm not going to judge the efficacy of OSR#1, but without any proven safety research and the long list of possible side effects, I would say that it would be irresponsible for any parent to give such a substance to their children.Â
And to Mr. Boyd Haley, the creator of this snake oil, I say "Shame on you".Â