OSR: The Littlest Consumers · 2010-07-14 07:15

CTI Science’s online “Recommended Intake” advisory for OSR — a synthetic industrial chelator marketed as a “dietary supplement” since late 2008, subject of numerous articles on this weblog and currently the focus of an FDA investigation and warning letter — features the following recommendations for dosage and administration:

“Recommended dose of OSR#1 for adults is 100 mg once daily… Recommended dose of OSR#1 for children 55-100 pounds is 100 mg once daily. OSR#1 is not recommended for children under 55 pounds or under 4 years of age.“

In a 2009 interview published on Facebook, CTI Science founder Prof. Boyd Haley claimed that OSR was “effective” at binding with mercury and simultaneously altering human metabolism, and that it would be beneficial to autistic children.

“Q: What was your inspiration?”
“A: DMPS and DMSA were invented in 1930’s. We haven’t made a new chelator since then…”
“Q: Is there anything in nature that acts as a chelator?”
“A: …When you get into mercury toxicity, from dental amalgams and vaccines, etc, the body doesn’t have a procedure to protect us, to bind and remove mercury or ethylmercury.”
“Q: How does OSR work in the body?”
“A:OSR goes into lipid/fat stores, mitochondria, etc. It’s not rapidly excreted. Has a long holding time in body and contains two thiol groups. If there is a hydroxy[l] free radical from metal toxicity or any inflammatory process, this thiol group on the OSR will react with it and scavenge it. This scavenging of hydroxyl free radicals salvages glutathione.”
“Q: Besides elevated glutathione, what are other signs that OSR is working?”
“A: Most commonly, bile changes. Feces change, become more normal, less odorous, less sticky/slimy. Intestinal pain decreases. Sleep is better. Eye contact is better. I’m not claiming OSR will cure autism. But it will set us 2 steps ahead…”
“Q: Could OSR help the fish industry?”
“A: Yes, I feel OSR or similar compounds could be used to make fish safer to eat. I’m not advertising this as a chelator though.”

After addressing the matter of dosing, he stated that although OSR’s half-life is unknown, it accumulates in the body.

“Q: What about dosing? Chats are saying different amounts than the bottle.”
“A: The amount we put on the bottle is for compliance with our submission to the FDA. We sell in 50-100-200 mg. That’s an estimate of the amount that is effective…”
“Q: What is the half-life of OSR in the body?”
“A: We don’t know the exact half-life… OSR’s half-life in the body is much longer than DMPS, DMSA and IV given glutathione. It’s a matter of days, not hours.”

He further admitted that no studies had yet validated OSR’s safety for young children, and declared that it should not be administered to them.

“Q: How much do you need to weigh to try OSR?”
“A: We don’t recommend for any child under 40 lbs. While we have no indications of OSR toxicity at any age or size, we also have no studies to infer it’s totally safe under 40 lbs… The safety of OSR should be looked at in a clinical trial. So don’t use OSR for kids under 40 lbs.”

(Prof. Haley did not explain the discrepancy between this 40 lb. minimum weight recommendation and the 55 lb. minimum weight published on the CTI Science website.)

In an apparent attempt to reassure prospective purchasers that he has exercised due caution in marketing OSR for consumption by autistic children, Prof. Boyd Haley includes the following caveats in the OSR product brochure:

“Although OSR#1 is a dietary supplement and not a prescription drug, it is only available through a medical professional or by prescription at this time.”

Doctors, dentists, pharmacists, chiropractors, and others who wish to purchase OSR for resale must acknowledge Prof. Haley’s dosage recommendation in their wholesale agreement:

“I understand that the recommended daily intake of OSR#1 is 100 mg per day for adults and children who are at least 4 years of age and over 55 pounds.”

Prof. Haley’s caveats, disclaimers and legal agreements notwithstanding, since OSR first went on the market in 2008, numerous reports posted to Internet discussion groups suggest that it has been frequently administered to children under 55 pounds and/or under 4 years of age, both by parents acting without a doctor’s supervision, and by recommendation of those authorized by CTI Science to sell OSR to their patients and customers.

[Messages from the ChelatingKids2 list moderator]
“[T]his is just me, forwarding a private message from Boyd Haley to me that he said I could share. He is in the very early stages of working on a new chelator…”
[nine months later]
“Anyone know when Boyd Haley’s chelator is coming out? …I’m hearing late fall…”
[one year later]
“Just trying to check on the dosage of OSR. …I have (from a very reliable source): The recommended dose is 100mg/day for patients over 50 lbs. We measured it and found that 1/16th of a teaspoon (called a minispoon) has about 140mg of OSR. So we have the little kids take half a minispoon or about 70 mg per day.“
ChelatingKids2, December 18, 2006; September 10, 2007; September 3, 2008
“My son has been on OSR for one day now and the only changes we have seen (not that we have expected to see any this quick) have been a prodigious increase in urination and thirst…”
[the next day]
“Second day of OSR. Again, A. is urinating profusely and drinking a lot of juice…”
[two days later]
“3rd and 4th days [on OSR] have brought a reduction in thirst and urination, however, my 20 month old son is still drinking more and urinating more than usual… We are taking 1/16th of a teaspoon (50mg) 2wice daily.”
ChelatingKids2, August 1, 2008
“We just got it from our DAN… [he] could never understand why the dosage was so low of 1/16th or 1/32nd of a teaspoon, he always said that this is low. BTW my son is 43 lbs.“
ChelatingKids2, October 12, 2008
“My son’s Dr. has me give him 1/8th of a teaspoon at night on an empty stomach. My son is 45 lbs. …He has had several poops lately that look like sand is in there what is this caused by??? …My Dr. is Kenneth Stoller in Santa Fe NM.”
ChelatingKids2, October 13, 16, 2008
“My son takes the same dose as yours and he is almost 50 lbs., so I think that’s about right. We use Dr. Stoller too…”
ChelatingKids2, October 12, 2008
“We’re just starting and my guy is only 27 months, so I’m a bit nervous… Our doctor is using it in Asheville.“
AutismWeb, November 20, 2008; October 29, 2008
“My 2-1/2 y.o. son (40 lbs) has been on OSR for 1 month. We give him 2 scoops at midday… Our DAN had us work up to 200mg daily. We started very slowly as directed with just 1/4 scoop to start and then added another 1/4 scoop every couple days… We… drive to Pleasanton each week to see our DAN, Dr. Lynn Mielke. We’re doing IV chelation.”
ChelatingKids2, March 10, 2009; July 23, 2009
“My son seems to be tolerating it just fine. We began with 1/4 scoop and now up to 1 scoop. We’re going to stay there for a while and then slowly increase to 2 scoops, which is the max for my son (5 yr. 50 lb).“
ChelatingKids2, March 9, 2009
“[My son] started on 1/4 of a capsule and is now on one capsule. He started at 48 pounds and is now at 50… We are not chelating with other chelators.”
ChelatingKids2, March 9, 2009
“[My son] was on 50 mg divided into 3 dosage daily in the past… We built up to 100 mg. Now I give him 100 mg at one time 4 days a week. He is about 50 pounds.“
[four weeks later]
“My son has been completely off OSR since mid March, soon after I posted our OSR experience. Having some uncertainty on my part, I decide to take a break from OSR and do another round of tests first and go from there… We had seen improvements in language development when on OSR, but we also experience some complication.”
ChelatingKids2, March 13, 2009; April 8, 2009
“Our DAN wants us to start this for our little peanut. I’m kind of scared though as she is only 36 lbs and it says on Boyd Haley’s site not to us for kids under 55 lbs. He wants us to start out with 25 mg and work our way up to 250 mg a day.”
[ten months later]
“My daughter is 5 yrs. old and we have been on OSR for about 7 months now. She is 42 lbs and we worked up slowly to 100mg… Urine Toxic Metal test showed that she was excreting: Aluminum, Arsenic, Barium, Cadmium, Cesium, Lead, Nickel, Thallium, Tin, and Tungsten… Fecal Metal test showed that she was excreting: Mercury (YAY!!!!), Antimony, Arsenic, Bimuth, Cadmium, Copper, Lead, Nickel, Platinum, Thallium, Tungsten, and Uranium.”
AutismWeb, May 1, 2009; March 12, 2010
“We are using it for my 24 lb almost three year old and 55 and 57 lb 7 and 9 year olds. We have had some trouble with sleep with the youngest…”
AutismWeb, May 1, 2009
“We put 26 month old DS on it in April.”
AutismWeb, June 19, 2009
“My son is 3 1/2 and has PDD-NOS, non-verbal… I read that OSR is only recommended for children over 4 years old and over 55 pounds. Is this absolutely necessary? and why? Our DAN! said I need to figure out what I want to do next, and he’ll help me do it…”
[six weeks later]
“…We’ve been on OSR for two weeks now. I started him on 1/4 of a capsule (Lee Silsby didn’t have the straight powder) and we’re up to 1/3 of a capsule now. He’s 38 lbs 3 1/2 years old. Has anyone ever heard of or experienced a side effect with OSR that might make him itchy? He’s scratching it seems all over. Even his teacher at school wrote me a note about it today.”
ChelatingKids2, May 27, 2009; July 10, 2009
“We’ve started OSR, but only every other day since, at 38lbs, he is below the weight level of 55lbs.“
ChelatingKids2, August 8, 2009
“[What dose of OSR are you on and how fast did you ramp it up?]”
“100 mg a day, he is 40 lbs. We started with maybe 10 mg (eye-balled), and ramped up to 100 mg over 3 weeks because I did not see adverse reactions, except after about 2 weeks I had a sulfur reaction… He got hyper and aggressive.”
ChelatingKids2, August 14, 2009
“We just met with my son’s DAN here in the Chicago suburbs and we’ll be using OSR as a ‘chelating agent,’ although Dr Boyd Haley does not call it that… My son is 3 and a half and has been diagnosed with autism.“
ChelatingKids2, July 23, 2009; August 15, 2009

Needless exposure of children to inadequately tested, potentially hazardous substances is indefensible, regardless of whether the instigator is a multinational corporation, an academic research center, a public residential institution, or a powder-peddling moonshiner working the alternative autism treatment hero circuit. The FDA is to be commended for finally investigating OSR, the target market for which is among the most vulnerable in society. Any action that the agency might take to prevent its further distribution to the public will serve to protect its littlest consumers, and to mitigate the exploitation of these children and of loving parents who long to alleviate their difficulties, by medical cultists and ideological entrepreneurs who recklessly profit from their misplaced trust.


All articles about OSR on Neurodiversity Weblog:

Haley’s Chelator: For Cats Or For Kids? (April 26, 2008)
A Fine White Powder (August 1, 2008)
The Industrial Treatment (August 8, 2008)
An Inquiry Emerges (August 14, 2008)
FDA To Haley: OSR#1 A Misbranded, Mislabeled, Unsafe Drug (June 24, 2010)
OSR: Fuel For Thought (July 7, 2010)
OSR: A Bevy Of Adverse Events (July 12, 2010)
OSR: The Littlest Consumers (July 14, 2010)

Articles about OSR in The Chicago Tribune:

OSR#1: Industrial chemical or autism treatment? (January 17, 2010)
FDA warns maker of product used as alternative autism treatment (June 23, 2010)
Supplement seller says FDA may be ‘confused’ (July 12, 2010)

Comments


  1. Wow! That is astonishing and disturbing.

    What I don’t understand is why the FDA has not already raided CTI. Children are being put in direct harm’s way.

    "On October 17, 2002, FDA investigators accompanied U.S. Marshals in a seizure of dietary supplements making drug claims from the Humphrey Laboratories of Lake Oswego, Oregon, doing business as Kirkman Laboratories. U.S. Marshals seized hundreds of bottles of Kirkman’s HypoAllergenic Taurine Capsules after FDA determined that these products made unsubstantiated claims to treat autism, a neurobehavioral disorder that begins in early childhood. Although the article is labeled as a “dietary supplement,” it is promoted by Kirkman Laboratories for autism on its Internet website and by accompanying pro­duct literature."

    http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm095929.htm

    That is a case of a company selling a real dietary supplement – their breach was advertising it as a treatment for autism. The case of OSR#1 is much more egregious – this is a totally synthetic chemical of substantially unknown toxicity, and potential long-term risks.

    — Broken Link    2010-07-14 08:07    #

  2. I believe that one is not allowed to submit a substance as a supplement after one has started clinical trials and made public announcements about the substance. I wonder how the actions surrounding OSR fit into that.

    The disclaimer about young children and low weights appears to be just a formality—ignored by all.

    — Sullivan    2010-07-14 23:12    #

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