Boyd Haley was a professor of chemistry who was very active in the failed thimerosal-causes-autism movement. He earned extra notoriety for trying to coin the phrase “mad child disease” (yes, a variation of mad cow disease) for autistic children. He also found notoriety for marketing a synthetic chemical as a “nutritional supplement”, calling it OSR#1. Prof. Haley is certainly persistent. He’s working on a clinical trial.
How did this come to pass? Well, one of the professors in Prof. Haley’s department found that a certain compound could effectively treat mining waste, removing mercury. Given his own interests, Mr. Haley started a company with an investor with the intent to bring this chelator to the public. The chelators used in medicine today were developed for lead and have been expanded to also treat mercury. I.e. there is no mercury specific chelator and this new compound would fill that gap.
All well and good, but in his zeal to bring this product to market, Prof. Haley cut a few corners. Chelators are drugs. The compound he was working on was synthetic. But Prof. Haley chose to rush the product to market as a “nutritional supplement”. Instead of calling it a chelator, he called it OSR#1. OSR standing for “oxidative stress relief”. Mr. Haley skipped the process to prove that his drug was safe and effective. Supplements have a much lower standard for safety and efficacy testing.
The FDA was not fooled. Mr. Haley and his company were given a warning letter which pointed out that the compound is not a supplement, it is a drug:
Your firm markets OSR#l as a dietary supplement; however, this product does not meet the definition of a dietary supplement in section 201(ff) of the Act, 21 U.S.C. § 321(ff). To be a dietary supplement, a product must, among other things, “bear[ ] or contain[ ] one or more … dietary ingredients” as defined in section 201(ff)(1) of the Act, 21 U.S.C.§ 321(ff)(1). Section 201 (ff)(1) of the Act defines “dietary ingredient” as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories. The only substance listed as a dietary ingredient on the labeling of OSR#1 is N1,N3-bis(2-mercaptoethyl)isophthalamide. N1,N3-bis(2mercaptoethyl) isophthalamide is not a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Further, N1,N3-bis(2-mercaptoethyl)isophthalamide is not a concentrate, metabolite, constituent, extract or combination of any such dietary ingredient. Thus, because OSR#1 does not bear or contain a dietary ingredient as defined in section 201(ff)(1) of the Act, this product does not qualify as a dietary supplement under section 201(ff) of the Act.
Also that the company was making claims that the drug could treat medical conditions and that the labeling was misleading in this regard. Further, that the toxicity was not adequately tested nor reported.
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).
That was in 2010. Prof. Haley and his company are now back, trying to get a clinical trial started on their compound. Essentially, they are trying to do what they should have done in the first place: get proper approval for a drug. An article in Chemical & Engineering News discusses this effort. Actually, it’s part of the cover story, “Building Pharma Molecules”
The story on Mr. Haley’s Company, CTI Science, has contracted with another company, PCI Synthesis, to manufacture the new compound.
The article is, well, a bit of a sales pitch and gets a few facts wrong. There’s a bit of spin on the FDA warning letter, for example:
“The effort to develop the compound as a mercury poisoning therapy accelerated in 2010 when the company received notification from FDA that it couldn’t market NBMI as a nutritional supplement until it underwent the full drug approval process”.
As we’ve just seen above, the compound is not a nutritional supplement at all. It needs the drug approval process because it is a drug.
The CEO of PCI is quoted as stating:
“The main starting material is cysteamine hydrochloride, which is basically an amino acid and found naturally. So it has attributes that could qualify it as a natural product.”
Which was part of the sales pitch for the OSR#1 in the old days and, again, the FDA disagreed. Just because something is synthesized from a natural product, that doesn’t make it a natural product. Otherwise there would be no synthetic products at all. Everything at some level comes from a natural product.
The article discusses how to qualify for a clinical trial the product must meet current Good Manufacturing Practices (cGMP). The article states:
The primary challenge was the removal of impurities to a level that meets cGMP standards
Think about that a moment. Apparently OSR#1 was sold with more impurities than would meet this standard–a standard for food and dietary supplements.
The article notes that, yes, this compound was sold as a product at one time
Sales to date: $1.5 million, as a nutritional supplement
$1.5M in sales. And the only reason it wasn’t higher was because the FDA stepped in. It was only out for about a year, as I recall.
I found this statement interesting, from the Wikipedia page for the compound:
In animal experiments, the amount of mercury in brain tissue was not increased, but also not decreased
So, even if you believe in the failed mercury hypothesis. What exactly were you supposed to get from this compound? I somehow doubt that even the strong believers in the mercury hypothesis think that removing mercury from, say, your liver will cure autism.
It does seem that Mr. Haley and his company are doing some of the right things now. Show that this drug is safe and effective for its intended purpose: chelation. There are some problematical statements that they may market this not as a drug but as a nutritional supplement, which is a non-starter.
By Matt Carey