Jan 19 2010
As part of her series on autism quackery, Chicago Tribune writer Trine Tsouderos has written another eye-opening article – this one about the drug OSR#1 that is being given as a “supplement” to children with autism.
The story highlights what I have been writing for years – that the current supplement regulation in the US under the Dietary Supplement Health and Education Act (DSHEA) is an anti-consumer farse.
OSR#1 is a drug. It is a compound that was manufactured by a company for its pharmacological activity. They claim it was developed as an anti-oxidant, but the Tribune reports that the compound may have originally been developed as an industrial chelator – a compound that binds heavy metals to clean them from soil or industrial spills.
OSR#1 is being marketed now as a “supplement” with claims that it is an antioxidant. But it is being used by parents in the autism community with the (wink wink, nod nod) understanding that it is a chelator, to treat presumed mercury toxicity as a cause of autism (a disproven hypothesis).
Even the antioxidant claims seem bogus. The company claims OSR#1 scavenges hydroxyl radicals, but as Vanderbilt’s Roberts is quoted in the Tribune:
“Hydroxyl radicals are the most reactive radicals that are formed,” he wrote to the Tribune. “They oxidize everything, so in essence all molecules are hydroxyl radical scavengers.”
So in essence the regulations that we have now allow for a company to take an industrial chemical, market it as a “supplement” with trumped up antioxidant claims (the latest buzz word), and yet the market for the drug is children with a serious illness, and the effect of the drug is a powerful pharmacological effect (chelation) that is normally only done under a doctor’s supervision because of the inherent risks. This is all done without providing any evidence for safety or efficacy.
According to the Tribune the FDA is looking into the matter – and says that the company is supposed to provide safety data (which does not mean necessarily research – just information as to why the compound can be expected to be safe, which can be nothing more than – it’s been used for a long time). However, the company has not provided the requisite information, and has not responded to the Tribune’s request for safety data.
All of this, in my opinion, seems like a conscious effort to drive a drug through the giant “supplement” loop whole that DSHEA has created in the regulation of drugs in this country.
Now, chemicals developed as powerful chelators are magically regulated as if they were food because the company slaps the latest supplement buzz words on their website.
DSHEA is broken. It needs to be fixed.
Hopefully the FDA with get a little more proactive, now that some public attention is being shown to this scandal. But the FDA famously lacks resources and teeth enough to deal with all the supplement scams that are out there. The public, and in this case vulnerable children, are left without even the most basic protections from potentially harmful and almost certainly worthless compounds.
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