A few years ago a fake supplement was marketed to autism parents for use on their children. The “supplement” was called “OSR #1”, OSR for “oxidative stress releif” or something to that effect. The name was a bit of a dodge, just as packaging it as a supplement rather than a drug was a dodge. It was/is a chelator. The chemical used–a novel synthetic chemical–was developed for use in environmental heavy metal polution.
This is obvious but worth noting: one can not “supplement” one’s intake of a chemical that humans have never been exposed to before.
If you remember OSR #1, you probably remember that the drug was pulled from the market. But you may be surprised to hear that it may be about to resurface.
The FDA found out that this chelator, this drug, was being sold as a supplement (which avoids thorough tests for safety and efficacy). The FDA sent the Boyd Haley, whose company was selling the “supplement” a warning letter that made it very clear:
The claims listed above make clear that OSR#1 is intended to affect the structure or any function of the body of man or other animals. Accordingly, OSR#l is a drug under section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1). Disclaimers on your website, such as “OSR#l® is not a drug and no claim is made by CTI Science that OSR#1® can diagnose, treat or cure any illness or disease,” do not alter the fact that the above claims cause your product to be a drug.
Moreover, this product is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of OSR#1 without an approved application violates these provisions of the Act.
Even as a supplement, OSR#1 appeared to be mislabled. Customers were not fully informed of potential side effects, per the FDA letter:
Your website states that” [s]ome reports of temporary diarrhea, constipation, minor headaches have been reported but these are rare and the actual causes are unknown,” as well as “OSR#1 is without detectable toxicity” and “OSR#1® … has not exhibited any detectable toxic effects even at exceptionally high exposure levels.” However, animal studies that you conducted found various side effects to be associated with OSR#1 use, including, but not limited to, soiling of the anogenital area, alopecia on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas, and lymphoid hyperplasia. Based on these animal studies and side effects known to be associated with chelating products that have a similar mechanism of action to OSR#1, we believe the use of your product has the potential to cause side effects, and the before-mentioned website statements falsely assert that the product does not have the potential to cause side effects. Therefore, these statements render your product’s labeling false or misleading. As such, OSR#1 is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a).
Mr. Haley’s company reportedly sold about $1.5M of OSR#1 as a supplement from his company CTI Science. I saw reports that OSR#1 was selling for about $2/pill so that’s maybe 750,000 pills. That’s a lot for somethiing untested for safety or efficacy. CTI appears to be a shortened version of the original name of the company: Chelator Technologies, Inc.. Chelators are drugs, not supplements.
But obviously I haven’t written all this to say that CTI Science doesn’t exist. It’s not ermesmedical (as their link would suggest), it’s EmeraMed. No idea why they have this confusion over ermesmedical/emeremed. That said, Emeramed describes themselves as:
EmeraMed Limited is a biotechnology firm developing the antidote – heavy metal chelator and antioxidant – Irminix® (Emeramide). The Company is working to obtain marketing authorization in the EU and the US for the treatment of mercury toxicity. Phase 1 and Phase 2a clinical studies have been performed.
They have offices in Ireland, Swedend and the US (Kentucky–home of Boyd Haley). But no mention on the website about who is involved with the company, which I find rather odd. They note that the drug is not yet approved, but that they may be able to supply it to people under an “early access program”. Yes, why wait for actual approval and confirmation of safety and efficacy. This would be for use as a chelator–no mention of work as an autism treatment. There never was a good reason to use this for autism. Boyd Haley was long a proponent that autism is a form of mercury poisoning. Put simply, Boyd Haley was wrong. Very clearly wrong.
As noted in their literature, they have been involved with clinical trials. For mercury poisoning. In Ecuador. No small irony there: many of Mr. Haley’s supporters complain that “big pharma” performs their clinical trials (or experiments, as his supporters would characterize them) in developing countries.
They are still pursuing patents for the treatment neurological disorders. No trial that I have found. Likewise for evidence of efficacy in humans. But a patent application.
A similar patent for treatment of COPD.
Should OSR#1 (under whatever new name) be approved for chelation, we can expect that it will return to the fake autism treatment world. Many still subscribe to the failed idea that autism is caused by mercury poisoning. That idea, pushed by Mr. Haley and others, was based largely on the idea that as mercury exposure from infant vaccines increased, so did the rate of identified autism. Biologically the idea was clearly wrong (autism and mercury poisoning are not similar). Also, even though mercury was removed from infant vaccines, autism rates have not fallen.
All that clear logic said, there still are people who chelate as an “autism treatment” and a new product will almost certainly cause a spike in the numbers trying chelation.
So, yeah, OSR#1 is gone. Except it may return soon under a new name. And likely a higher price tag. And it still won’t be a real treatment for autism.