The story broke yesterday that Dr. Boyd Haley has been given a warning letter by the FDA about his chelating product, OSR #1. The FDA has warned Dr. Haley that his own safety tests indicate the possibility for adverse reactions and that since the substance is not found in any food or mineral, it is not a “supplement” as he markets it, but a drug. Drugs require much higher standards of proof of safety.
One could make an easy bet that the Age of Autism blog, which has helped tout the drug/supplement OSR, would come to Dr. Haley’s defense. The way they went about this is quite surprising to me. In Chicago Tribune Protecting Consumers Against Natural Supplement (Again), the Age of Autism writes:
CTI Science got a letter from the FDA about its ingredients. They will respond. Dr. Weil got a similar letter last year when he dared to offer an immune support formula in place of the H1N1 vaccine. Drug companies get the letters every day of the week for their advertising claims. You think 50,000 people in America even know what OSR is? They will now.
Yesthe letter from the FDA is no big deal. One of their favorite alternative medical practitioners got one last year, and the pharmaceutical companies get them too. While it isn’t mentioned in the AoA piece, Dr. Weil appears to have ignored the warning letter without any repercussions as no response has been recorded .
Yes, “you don’t have to respond to the FDA’s letters” appears to be a valid excuse to the Age of Autism.
There is a major difference between the warning letters sent to Dr. Haley and Dr. Weil. Dr. Haley’s letter shows that his own safety data, data not previously made public from what I can see, indicates the drug he is selling has the potential to cause adverse reactions. Dr. Weil appears to be only making claims of efficacy which he can’t back up. Only.
And, yes, big companies flout the FDA letters too. Merck, a giant pharmaceutical company, has one warning letter . One. That’s for Vioxx. Merck didn’t respond. That didn’t exactly go well for them, did it?
The full warning letter to Dr. Weil is quoted below.
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<a href="http://leftbrainrightbrain.co.uk/2010/06/supporters-of-osr-1-drug-given-to-autistic-children-see-fda-warning-as-no-big-deal/">Supporters of OSR #1, “drug” given to autistic children, see FDA warning as no big deal</a>