Jun 25 2010

Marketing Drugs as Food to Kids with Autism

It has been a slow blogging week for me. I have been far busier than I thought completing my project – which I will be happy to tell you all about once I have the green light to promote it.

Meanwhile, here is an excellent article by Trine Tsouderos regarding OSR#1, which is an oral chelator being used by some to treat their kids with autism. The marketing of OSR#1 represents many of the problems that I and others have been blogging about for years.

OSR#1 was originally developed as a chelating agent to be used in industry – not for medical use. It binds to heavy metals, like mercury, and therefore those in the anti-vaccine community who still cling to the discredited notion that autism is a form of mercury toxicity believe it can be used to treat autism.

Boyd Haley, a retired chemist, and apparently innocent of any actual medical training, has been selling OSR#1 online as a treatment for autism. Using a powerful industrial chelator to treat a disease like autism certainly sounds like it should qualify as a drug – and therefore should fall under the purview of the FDA – and the FDA agrees. That is why the FDA is now going after Haley, and it seems that their investigation was triggered by a previous report written by Trine about unproven Autism therapies.

But Haley tried to pull a fast one, taking his lead from the supplement industry. He actually attempted to market OSR#1 as a dietary supplement. Trine reports:

In the interview last year, Haley called the product “a food” that is “totally without toxicity.” Haley said the compound had been tested on rats, and a food safety study was conducted on 10 people. Asked to provide documentation of the research, he stopped communicating with the Tribune.

Meanwhile, Haley’s own limited testing in animals showed that the drug can cause serious side effects, like hair loss and pancreatic damage – clearly not without toxicity.

The game Haley is playing is not fundamentally different than the one that many supplement marketers play, and are allowed to play by the lax regulations in this country and many others. They sell drugs clearly intended for their pharmacological actions as if they were supplements so that they do not require any evidence of safety or effectiveness.

Haley’s problem is that his drug, OSR#1, is blatantly not a nutritional supplement and is being used to treat a disease – an FDA no-no. Even still it took an expose in a major newspaper to get the FDA’s attention. So far they have sent a letter of warning to Haley and have threatened action, but have not yet taken any direct action. Hopefully they will soon – nothing short of shutting down Haley entirely would be appropriate. In fact, It certainly seems to me that Haley is attempting to practice medicine without a license. There was a time in this country when that meant something.

As you might expect, the Age of Autism and the anti-vaccine movement in general have embraced Haley. Even though he is giving a toxic drug without proper testing to children, he is a hero in their eyes simply because he is backing up their unscientific beliefs about mercury. That’s all it takes, apparently – believe their pseudoscience and you are a hero, doubt it and you are a baby-eater. It’s such a stark black and white world they live in.

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