Chicago Tribune, Trine Tsouderos's article.
Neurodiversity Weblog: excellent synopsis of how OSR#1 violates federal law, contains the letter from FDA, and links to other blog postings at the weblog concerning OSR#1.
LBRB, first article covering Tsouderos's article.
LBRB, second article covering predictable AoA eh, so what? response.
Prometheus, A Photon in the Darkness.
Autism News Beat.
My earlier coverage.
AoA's response: it's a natural supplement! Can't you leave us alone?
AoA's response is typical, and their loyal readers prove that cogent thought is often just outside their reach.
"It takes a special brand of journalist to so willfully, malfeasantly, and relentlessly insist that the citizenry remain in the dark."
"Exactly Mary, I swear if Big Pharma is freaking out about it, then it must be working... I'm going to give my DAN! a call today! Thanks AOA!"
"Dr. Boyd Haley is a thoughtful and careful scientist who would NEVER release a product unless he had done his due diligence."
"Thanks for reminding me. If the FDA (pharma's lap dog) is going after this stuff, it must work. I better buy this stuff today. The FDA only goes after threats to pharma."
OSR#1 is available at over two dozen pharmacies. I wonder if they're all still selling it in light of this letter from the FDA? I can order it online here, still, for $80, with $9 shipping. I wonder if that last AoAer quoted really believes what she wrote? I hope if she orders it, she shows her commitment to the product by using it on herself FIRST.
If you're of the opinion that pricier means better, you can by OSR here for $220. Wow. Must be good stuff! Here's what the website has to say about it:
"Introducing a new Antioxidant from Boyd Haley that is a highly purified, safe, non-toxic nutritional supplement. Not recommended for children under 4 years or pregnant or lactating women as a precautionary principle.
Serving Size: 100 mgs. Servings per container, 90. Pharmaceutical spoon enclosed delivers 100mgs. Active ingredient: N1, N3-BIS (2-mercaptoethyl)isophthalamide. Other ingredient: None. May be taken with food or drink.
Dosages, indications and any other information contained herein is suggested use only and not to be considered treatment recommendations. Please consult with a healthcare provider for treatment of any illness or condition, especially if you are pregnant, breast-feeding or considering treating a child. We suggest that you consult a licensed physician if you have any health problems and you require a medical diagnosis or medical advice or treatment. Our products are not intended to diagnose, treat, cure, or prevent any disease. For all matters that relate to your health, please contact your physician.
This product is available only to US residents. We regret that we are unable to ship outside of the US."
CTI hasn't changed its website, yet, either, and still asserts that "OSR#1® is a toxicity free, lipid soluble antioxidant dietary supplement that helps maintain a healthy glutathione level. OSR#1® does so by scavenging ROS (free radicals) thereby salvaging the naturally produced glutathione. Both OSR#1® and glutathione scavenge free radicals, allowing the body to maintain its own natural detoxifying capacity."
It's clear from the FDA letter that this doesn't appear to be the case:
"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)."
So much for Haley's claim of "toxicity free."
Haley tweeted on May 13th: "OSR#1 is the world's best lipid-soluble antioxidant. What good is an antioxidant if it can't get inside cells to scavenge ROS?" Back in February, he tweeted this: "Contrary to the Chicago Tribune implication, OSR1 has undergone extensive safety testing. The truth is at www.OSR1.com. Please retweet!" Huh. Guess that retweeting had the FDA looking at that testing, huh? Guess that lead to the letter.
Plenty of people out there are using not only their children but themselves as guinea pigs for things like OSR#1. Especially interesting are some of the messages on the Yahoo Autism-Mercury group, in particular, what Cutler (of the Cutler protocol) has to say about OSR (well worth the read to see one woonut attack another).
What the OSR#1 story shows is that people believe claims with no strong evidence for them, that exclusivity of products make them more appealing, that renegade mavericks going against the man (big pharma) strikes a chord, that presentation matters (being a kindly looking older gentleman), and that people who are hurting (emotionally or physically) are susceptible to buying into dangerous woo when answers are either not forthcoming from mainstream medicine or the opposite of what the individuals wish to hear.