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.
15 Responses to “Marketing Drugs as Food to Kids with Autism”
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I hope Trine continues this excellent reporting and possibly investigates whether any of the children subjected to this untested drug have suffered ill effects.
Looking forward to hearing about the project Steve.
I’m grateful that Trine’s article lit a fire under the FDA’s bureaucratic ass. I’ve been waiting for this for two years now. The FDA has been aware that Haley was misrepresenting OSR, a completely synthetic chelator, as a “dietary supplement” ever since August 2008, shortly after he began selling it to the public. That’s when I wrote to University of Kentucky officials to express my concerns about OSR (the university owns the Multidentate Sulfur-Containing Ligands patent from which OSR was derived); I cc’d CDER and CFSAN officials on the letter, and followed up with them to reiterate that OSR was being specifically marketed for consumption by disabled children. That letter is at:
http://www.neurodiversity.com/weblog/article/168/
@kathleenseidel
My viewpoint on FDA (from a limited perspective) is that unless the product is well-known or very, very widely used, and that it poses a significant hazard, they are a bit slow to take action. Usually, if the risk of harm appears to be relatively low, they move somewhat cumbersomely.
That said, they are also grossly underfunded to do the job they’re given. That’s been a problem since they were first created. Tons of products to regulate and not enough people to handle the job well.
Kudos for writing to them, though! I contacted them about those bogus Kinoki foot pads a while back after seeing an infomercial on TV.
GRRRRAAAAAGHGHGHG!
How do parents become so lost to all sense that they will give their child and untested drug?
Here is my reading of the future (I may give up on being skeptic and just join the woo peddlers as a psychic)
It will take the FDA about 4 years to rid the world of this horror. In that time several thousand autistic children will have pancreatic damage and other side effects. Those same parents will then sue Haley and blame the FDA and generally make themselves into victims.
I once again say that if we could instill critical thinking into the population as a whole, the Haleys of the world couldn’t thrive. Not that I am against the regulation of the Haleys. But we have become a nation of people who assume too much. I would guess that at least half of the folks who buy have a vague idea that he couldn’t sell it if was dangerous. The gov wouldn’t let him. Another high percentage decided that the big pharma were bad because drug prices are too high and so that means Big Pharma is selling poison just to make money. (or some derivative of that)
While I think the regulation is necessary, I also wonder if what dulls critical thinking. It helps instill the “someone else is taking care of that” presumption. Of course it isn’t helped by the bad logic associated with big Phara profits.
@Sara
If you can tolerate it, you can get some insight into their thinking if you wander over to AoA and read some of the comments on their post about Trine Tsouderos’ article. I posted a comment, as well, but since they censor me, it won’t show up. Luckily, I cross-post everything over to Silenced by Age of Autism.
There was actually one comment there that scolded AoA. I’m always amazed when those types of posts show up.
SARA-
I think the idea, “someone else is taking care of that,” does dull critical thinking.
It is important for people to understand that regulators can’t possibly deal with everyone making claims, that regulators can get it wrong even when they are paying attention and that regulators often have conflicting interests that they are weighing (Life, liberty and the pursuit of happiness allows for some shenanigans– no?)
I would agree that this situation is a good reason and good opportunity to promote critical thinking.
Wait… do I understand this correctly? Parents who freak out about trace amounts of formaldehyde and what-not in vaccines are feeding their children industrial solvents?!
The quote by Kim Stagliano who sprinkles the white powder on her three daughters’ breakfast sandwiches and orange juice, “We’ve seen some nice ‘Wows!’ from OSR,” really really disturbs me.
I guess if my kids were at risk of hair loss and pancreatic failure due to my unethical actions that would be pretty ‘wow’ too – but not the good kind of ‘wow’.
“Wait… do I understand this correctly? Parents who freak out about trace amounts of formaldehyde and what-not in vaccines are feeding their children industrial solvents?!”
What? You expected rationality from this mob?
Pinky, The AOA managing editor, Kim Stagliano likes to sprinkle, OSR #1 on her 3 daughters’ morning breakfast sandwiches and orange juice drinks. Do you think she intends to take her daughters to the mouse doctor for treatment side effects?
@HHC – anything is possible
*squeak*
WOW!
I just finished my honors thesis using chelating agents to increase metal availability for phytoremediation. These agents are just plain nasty and feeding them to kids is just stupid.
“I have been far busier than I thought completing my project.”
It’s not that Novella brothers ‘boy’ band idea is it? I though Rebecca had talked you out of that one.
“Kim Stagliano who sprinkles the white powder on her three daughters’ breakfast sandwiches and orange juice.”
Doesn’t this count as child abuse? To clarify the situation perhaps someone ought to publish a list of industrial chemicals you can feed your children without being arrested.
Anyone have any hints about HOW to read AoA? Every time I get on their site, my internal BS detector starts ringing so hard that a get a splitting headache.
@CivilUnrest
Well, you could start by purchasing BlatherScrubber 2009. Most of the bugs have been worked out, and it tends to prevent brain scrambles, though there are still certain articles at AoA that are just too much for it. Another option is VirtualLoon 1700 (the versions post-1800 really just have too much science to fully integrate the pseudomedicine to be found over there), which will help you get into a temporary pre-scientific mindset. I am sure other products are available, but those are, I feel, the best ones to prevent mental blue screens of death.