Geier Suspension Upheld
• Maryland Authorities Charge "Lupron Protocol" Promoters With Unprofessional Conduct, Unlicensed Practice of Medicine
• Geiers Sue OAP Petitioners' Attorneys For $600,000
• Maryland Medical Board Suspends Dr. Mark Geier's License
• Fraud Watchdog Sounds Autism Fundraising Scam Alert
• 2011 IACC Strategic Plan for Autism Spectrum Disorder Research
• U.S. Supreme Court Ruling in Bruesewitz v. Wyeth
• MIT's Face-to-Face Online Study
• A Complete Abandonment Of Principle
• OSR: Off The Market
• OSR: The Littlest Consumers
• OSR: A Bevy Of Adverse Events
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This afternoon, I sent the following letter to James W. Tracy, Vice President for Research at the University of Kentucky; Ada Sue Selwitz, Director of the University of Kentucky Office of Research Integrity; and Helene Lake-Bullock, Research Compliance Officer, University of Kentucky Office of Research Integrity.
August 1, 2008
Dear Mr. Tracy, Ms. Selwitz and Ms. Lake-Bullock,
I understand that Professor Boyd Haley of the University of Kentucky Chemistry Department has recently developed a chemical compound, N,N’-bis (2-mercaptoethyl)isophthalamide, which he has begun to market as a nutritional supplement under the trade name “Oxidative Stress Relief” or “OSR.” Recent online discussions of OSR raise many questions about the manner in which this product has been represented to the U.S. Food and Drug Administration, and the manner in which it is being promoted for consumption by autistic children. I am writing to share my concerns in detail in the event that the University of Kentucky is in any way involved in Prof. Haley’s enterprise.
As you may already be aware, Prof. Haley is a vocal proponent of the unproven hypothesis that autism is a consequence of mercury poisoning, and of medical therapies that purport to improve health by the chelation of minerals from the body. You may also be aware that Prof. Haley has offered expert testimony in civil lawsuits alleging harm through “mercury poisoning,” although the courts have routinely dismissed his testimony as unreliable. He is also a designated expert witness for petitioners in the Omnibus Autism Proceeding (OAP), which consolidates over 5,000 Vaccine Injury Compensation Program claims. As one of the few scientists who assert that environmental mercury exposure leads to autism, Prof. Haley enjoys a hero’s status among parents who suspect that their children’s autism was induced by thimerosal-containing vaccines.
In February 2007, Prof. Haley registered the corporation “Chelator Technologies” with the Kentucky Department of State. Subsequently, at conferences attended by parents of autistic children and medical professionals who share his unorthodox convictions regarding autism causation, he revealed that he was developing a new drug for the purpose of mercury detoxification. In his lecture at the May 2007 Autism One conference, “Mercury Toxicity and its Relationship to Neurological Diseases,” Prof. Haley described his “New Chelator Concept” (p. 62), and favorably compared the substance he was developing with dimercaptosuccinic acid (DMSA) — an FDA-approved drug for the treatment of lead poisoning — and 2,3-dimercapto-1-propanesulfonic acid (DMPS), an unapproved chelation agent.
Word of the new chelator spread, along with reports of Prof. Haley’s progress in obtaining FDA approval, and hints of a change in marketing strategy.
Dr. Haley’s new chelator will come out around Christmas time? Ho Ho Ho! — ChelatingKids2, September 28, 2007
Is this true? Is he finally done with it? does anyone know anything about this? — ChelatingKids2, September 28, 2007
It’s been done for awhile. It’s in the testing phase which take a lot of time. They have to start with mice and whatever else, then go to primates, I think. — ChelatingKids2, September 28, 2007
I talked with Dr. Haley this past weekend and they are waiting for FDA approval. Since all the safety studies are in place, they are hoping to hear soon. But with this kind of process, you can never know. He is such a brilliant man and I am this product will help many people. — ChelatingKids2, October 3, 2007
Oh, dear. FDA approval for a mercury chelator for something the FDA won’t admit is a problem. That is a problem. — ChelatingKids2, October 3, 2007
I thought he was going to market it as an antioxidant so he didn’t have to deal with FDA approval. — ChelatingKids2, October 3, 2007
In January 2008 Prof. Haley amended the name of his corporation from “Chelator Technologies” to “CTI Science.” The Kentucky Department of State currently indicates that CTI Science is currently an active corporation in bad standing. The company’s one-page website, http://www.ctiscience.com, identifies “CTI” as an acronym for “Chemistry Technology Imagination.” The domain name “ctiscience.com” is owned by Mr. Ramesh Ratan of Lexington, Massachusetts. Mr. Ratan is a former executive with Repligen Corporation, known for its promotion of secretin as a pharmaceutical treatment for autism.
On February 1, 2008, Prof. Haley submitted to the FDA notice of intent “to introduce a new dietary ingredient for use as an antioxidant, N,N’-bis (2-mercaptoethyl)isophthalamide (code name CT-01), into interstate commerce on or after 15 June 2008.” The letter was prepared on CTI Science letterhead, and signed, “CTI Science, Inc., Boyd E. Haley, Ph.D., President; Professor of Chemistry and Biochemistry, University of Kentucky.” Material Safety Data Sheets accompanying the submission indicate that “CT-01” is composed of two chemicals. Cysteamine hydrochloride (also known as mercaptamine hydrochloride) is an animal feed additive also used as an investigational new drug for the treatment of cystinosis, a rare kidney disorder. The second ingredient, isophthalic acid, is used in the manufacture of resins and industrial coatings. (100g of cysteamine hydrochloride can be purchased for about $100; 500g of isophthalic acid costs about $20.) Material Safety Data Sheets indicate that both cysteamine hydrochloride and isophthalic acid are to be used for research and development only, and are not for drug, household or other uses.
In his “Premarket Notification for a New Dietary Ingredient,” Prof. Haley stated:
“We will claim only that CT-01 is an antioxidant.”
At the May 2008 Autism One Conference, Prof. Haley lectured on “The Retention Toxicity of Mercury and its Neurological Implications.” Although the accompanying slides were substantially similar and often identical to the slides he displayed in 2007, in the 2008 version the word “chelator” was in most instances changed to “antioxidant.” For example, “First Generation Mercury Chelating Agents” (2007, p. 63) was changed to “Antioxidant Chelating Agents” (2008, p. 58); “New Chelator Concept” (2007, p. 62) was changed to “New Antioxidant Partitioning Concept” (2008, p. 62); “Toxicity Study of Chelator” (2007, p. 65) was changed to “Toxicity Study of Lipid Soluble Antioxidant” (2008, p. 63).
Whereas Prof. Haley originally stated that animal safety studies were “being done for the purpose of obtaining FDA approval for these new chelators” (2007, p. 66), in 2008 he modified the text to state that the same studies were “being done for the purpose of obtaining FDA approval for these new antioxidants” (2008, p. 64). Whereas in 2007 he maintained that his product was a pharmaceutically effective “chelator” for the removal of mercury, in 2008 he modified the text to state that his invention was an “antioxidant” that “releases” an “antioxidant chelator” for “treatment” of unspecified conditions.
A new chelator releases a very effective mercury chelator that enters hydrophobic areas where most mercury may be located. Because of its hydrophobic nature it stays in the body for a much longer time. (Autism One 2007, p. 62)
The new antioxidants release a very effective antioxidant chelator that enters hydrophobic areas. Entering the hydrophobic regions increases the time in the body enhancing the treatment capability. (Autism One 2008, p. 65)
Interest in the new product mushroomed. Parent reports before and after the conference indicated a common understanding of the reason for the shift in terminology — to bypass FDA regulations for approval of a new drug formulation by representing it as a “dietary supplement.”
LOL…..it’s an “antioxidant!” not a chelator. Important not to call it a chelator. ;~) All I hear is all’s going well and we’re close. — ChelatingKids2, March 31, 2008
…if this stuff does what it is supposed to do it will be a gem of a ‘super antioxidant’
Ahumm……… C h e l …. a t or. — AutismWeb, May 21, 2008
Please! More informations about the new Boyd Haley’s ANTIOXIDANT. Will it be Rx only? Is it in oral or TD form? Where will it be available for purchase? (And, please, let’s call it ANTIOXIDANT, as Dr. Haley wants.) — ChelatingKids2, May 26, 2008
Parents expressed their eagerness to try out the new product on their autistic children as soon as it became available.
Hey everybody. I’ve heard that an announcement was made at Autism One Conference regarding B. Haley’s new antioxidant being available on June 19th… My son’s DAN wants to start chelation in July, so this could be good timing!!! — Autism Speaks, May 26, 2008
I want to start getting the metals out of my boy, but wonder is the OSR better than DMSA and ALA? I read Boyd Haley’s slide presentation from the Autism one conference, and he makes DMSA and DMPS sound like antiquated and ineffective chelators invented in the 1940’s. But so many parents have used them with success. What is a parent to do? Time is of the essence, and I hate the thought of waiting until there is more data on the new stuff, but yet on the other hand, do not want to shortchange my son if there is a better chelator out there. — ChelatingKids2, July 9, 2008
As new interventions go, considering the source, I believe it offers the most promise of anything to come around in years (and yes, we’ve doing this for years). Some won’t be comfortable trying it until they see a study (or least a LOT of positive anecdotal evidence from other parents), whereas others (like me), with tough nut kids who have basically exhausted most options, will be among the first to order. — Autism-Mercury, July 12, 2008
On June 17, FDA’s Division of Dietary Supplement Programs issued an opinion detailing specific problems with Prof. Haley’s submission. No evidence was presented to establish that OSR or its components have any established use as a food for human beings. Since cysteamine hydrochloride has been and continues to be classified as an Investigational New Drug, it cannot also be legally classified as or incorporated into a dietary supplement.
It is unclear on what basis you assert that “N,N’-bis(2-mercaptoethyl)isophthalamide” that is the subject of your notification is a “dietary ingredient” …that may be lawfully used in dietary supplements. A dietary supplement means, among other things, a “product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).
FDA requests that you submit information explaining your basis for asserting “N,N’-bis(2-mercaptoethyl)isophthalamide” falls under the definition of a dietary ingredient…
In addition, your notification states… that “[t]here may be enzymes that could hydrolyze the amide linkage producing the two products shown below.” This statement is followed by a discussion of the safety of isophthalic acid (1,3 dicarboxybenzoate) and cysteamine.
The statutory definition of dietary supplement… includes and excludes from the definition of dietary supplement certain “articles” based on their regulatory and marketing history. While the term dietary supplement “does include an article that is approved as a new drug… and was, prior to such approval… marketed as a dietary supplement or as a food” …the term dietary supplement does not include an article… authorized for investigation as a new drug… for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval… or authorization marketed as a dietary supplement or as a food.
In order to determine the eligibility of “N,N’-bis(2-mercaptoethyl)isophthalamide” to be a dietary supplement, FDA requests that you provide information as to whether “N,N’-bis(2-mercaptoethyl)isophthalamide” may be used as a dietary source of cysteamine.
The opinion ended with a warning of the likelihood that OSR cannot legally be marketed for human consumption.
For the reasons discussed above, the information in your submission does not provide an adequate basis to conclude that your “N,N’-bis(2-mercaptoethyl)isophthalamide” will reasonably be expected to be safe. Therefore, your product may be adulterated under 21 U.S.C. 342(f)(1)(B) as a dietary supplement that contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Introduction of such a product into interstate commerce is prohibited under 21 U.S.C. 331(a) and (v). — June 17, 2008; filed to FDA’s public docket July 6, 2008
An FDA opinion, however, is just that — an opinion with no force of law, which the recipient may either heed or disregard. Prof. Haley chose to disregard it. As online discussions continued, several individuals stepped forward to report “inside information” allegedly originating with Prof. Haley himself, indicating that the product would soon be available for purchase from doctors associated with Defeat Autism Now.
This is too good to keep to myself. I just got an e-mail from Boyd Haley, who informed me that according to his lawyer, final approval to sell OSR (Oxidative Stress Relief) came through just today. I’m on an e-mail list to receive eventual ordering instructions, and I’ll post them as soon as I do. — ChelatingKids2, July 1, 2008
I asked Boyd about this via e-mail. He was very coy about discussing anything but its antioxidant properties, but did clearly state that he has no concerns about its safety for use in both adults & children, regardless of their ‘oral status’ (his words). — ChelatingKids2, July 7, 2008
A buddy of mine and I are getting very impatient; he wants to try some on his father who has Alzheimer’s as well as on his 6 year old son with Autism. My son will be 9 in October. Surely someone must know Boyd Haley well and can find out what the hold up is. — ChelatingKids2, July 20, 2008
I’ve heard that they had to wait for final FDA approval and the encapsulating company was in the middle of a flood in Indiana. Also, Haley has decided to start off (for precautionary reasons) channeling the stuff through some DAN docs so that reactions, etc. can be monitored and some pre and post testing can be done. — ChelatingKids2, July 20, 2008
A person using the pseudonym “Human Clay” joined the Autism Speaks forum on June 1, 2008. He or she has since functioned as a conduit for communications purporting to originate from Prof. Haley’s private mailing list, and has posted exclusively on the subject of OSR.
The OSR (oxidative stress relief) should be out June 19th. Boyd Haley was kind enough to send me a sample of the compound and I have been taking it for myself because I had some redistribution problems from ALA+DMSA. Hopefully it will help with the headaches from the DMSA and ALA. Haley said he has been taking it for over a year, and he has never felt better! — Autism Speaks, June 1, 2008
[I]t should be available through a website on June 19th… I don’t have a weblink to where it would be sold. I will post as soon as I find out. I don’t know the cost either, but he did say he wanted to make it as affordable as possible! — Autism Speaks, June 6, 2008
The OSR is not available yet, he was hoping the approval process would be over by now. I don’t have a date yet. Boyd has me on his email list and will send me the link when it is available to sell. He really can’t share any specifics on tests right now. He does tell me that toxic people have had their Hg levels checked after a month, and they have decreased significantly. I can’t get a definitive answer on whether OSR crosses the blood brain barrier. He also told me toxins are not excreted through the urine, so I asked if it comes out through bile, stool, and did not get a response. He has to be really hush hush about this. But, he has responded to pretty much all my emails, and for a couple of weeks, we were emailing everyday. He was kind enough to send me another bottle as I ran out. I am happy to report my headaches from redistribution are gone after only 2 weeks of use. I also had a period of no acid reflux for 5 days, which normally hits every day. I’ll keep you all updated, I know it’s tough waiting, but I know he is a good man and is doing all he can to make sure that this stuff gets out to you. — Autism Speaks, June 27, 2008
I bring forth good news to you all!! This is Boyd’s response to one of my questions. ‘OSR is now legally for sale as we have met the needed information for safety that the FDA requires. Boyd’ I just emailed him to get where it would be sold. It won’t be much longer!! YAY… He responded and told me I was on the list on how to order OSR, he will send me the info on how to order later on this week!! I’m so excited!! My toxic family needs this stuff. — Autism Speaks, June 30 – July 1, 2008
The latest news on OSR. Right now, OSR has to be ordered by a physician. I know a doc that knows Boyd and is ordering some for myself. It costs $180, will come in 18 gram bottles, 100 mg per day, which is a 6 month supply. Let me know if you have any questions. — Autism Speaks, July 8, 2008
On July 23, 2008, an announcement was posted to an Autism Speaks Message Board discussion of OSR by a new member, “biodds,” who stated that he had a supply of OSR for sale, and welcomed readers to visit his website, http://www.totalmouthfitness.com. Dr. Paul G. Wilke is a San Antonio, Texas “biological dentist,” practitioner of “cavitation surgery,” and former treasurer of the San Antonio Bible Based Science Association, which promotes “young earth scientific creationism.” Dr. Wilke’s website describes OSR as a dietary supplement, then suggests that it influences metabolic processes purportedly involved in a range of medical conditions, including autism.
We are proud to announce the release of an EXCITING new dietary supplement called OXIDATIVE STRESS RELIEF (OSR). Research shows that many chemicals and drugs induce oxidative stress in our bodies. Oxidative stress also plays a role in many diseases such as Autism, Rheumatoid Arthritis, heavy metal poisoning, Parkinson’s, ALS, Alzheimer Disease and others. OSR was just approved for sale by the FDA (Food and Drug Administration) in July of 2008. This is too new to make any definite predictions, but Dr. Wilke feels that this may be the best dietary supplement in decades. It will be available in capsules in the near future but for now, it is only available in a powder form. A six month supply is $350.00 and is available for purchase at our office. Call us today!
In further posts to the Autism Speaks forum, Dr. Wilke contended that mercury from dental amalgam and thimerosal-containing vaccines impairs embryonic and infant development, and assured list members that OSR was “FDA approved.”
Dentistry has a great deal to do with Autism. The mercury from mercury amalgam fillings vaporizes continuously affecting both the sperm and egg at conception. The embryo then concentrates the mercury from the mothers blood by about four fold. If this doesn’t cause a birth defect or miscarriage due to the death of the embryo, then the newborn drinks the mothers milk which is laced with the mercury from the fillings. Then add the 200 times more toxic ethyl mercury (compared to the elemental mercury from fillings) in the vaccines and it’s a miracle more of our precious babies don’t have Autism. So, what does a lowly dentist have to do with Autism, a whole lot! It’s the dentists from the IAOMT that educated Dr Boyd Haley about the harmful effects of mercury from fillings. Be thankful that OSR was FDA approved and is available. Whether you buy it from me or someone else, if you can find it, makes no difference to me. I invested $8400 in a supply for my family, friends, and patients and will offer it to anyone for the same price I charge my patients. Paul G Wilke DDS — Autism Speaks, July 23, 2008
When list members protested the price of OSR, called attention to the fact that the FDA does not approve but only “lists” dietary supplements, and observed that it is illegal to market a dietary supplement with assurances that it is “FDA-approved” and without a “Supplement Facts” label, Dr. Wilke described the product’s development and testing, declared his and his colleague’s benevolent intentions, and personally disparaged his questioners.
Wow, there sure are a lot of backbiting, contentious replies in this thread! Most of you need to chill. Dr. Haley developed this supplement especially for ASD. He said if the FDA didn’t (I’m not sure what word to use here since some are so particular about the word “approved” by the FDA) agree that OSR is safe for humans, that he would publish the recipe on his website and we could all make it in our kitchens. He wants to help people so strongly and he is so convinced about the safety of OSR that he would forgo all profits as the OSR developer as long as people could have it. I have not seen such a pure motive by anyone in years!
Haley first started with goldfish to test the toxicity of many different possible compounds. He added it to their water. If they survived he did further testing. The one he selected, isopthalamide, is fat soluble I believe. Note that heavy metals accumulate in the fatty tissues of our body. To make it water soluble to increase absorption he added two molecules of glutathione (GSH) which I believe is our bodies’ main antioxidant.
Haley is working on an article to satisfy everyones desire for the facts on his scientific studies on OSR. My limited knowledge comes from two conferences where he spoke. These were the most recent IABDM and IAOMT meetings. Yes, both biologic/holistic/alternative dentist meeting. These dentists have learned a great deal about heavy metal poisoning because our profession is responsible for the main source of mercury poisoning in the population from mercury amalgam fillings. We learn how to properly and safely remove them.
Dr Haley said that GSH levels quadruple in the test animals. The first animal he tried it on was his nearly dead elderly cat. His cat is now running around like a kitten. He also treated cats that were poisoned with melamine, the Chinese pet food poison. For instance two cats from one family were poisoned and Haley only treated the cat that was worse. It fully recovered. The cat with much fewer symptoms was not treated and went on to eventually die.
He said that rats were injected with six times the lethal dose of mercury. If not treated they would die in six hours. If given OSR, they totally recovered with only a few symptoms for a day or two. He gave some animals I believe 1000 times the recommended dosage of OSR for extended time periods. They were then sacrificed and tissue samples examined by a pathologist. No organ damage or neoplastic changes were seen in any areas of their bodies.
My whole family is taking it and I believe it is the most significant nutritional supplement in decades. For many reasons, some legal, many things can’t be said about nutritional supplements. No one should make any health claims about OSR. Please understand, if this was approved as a drug, very few of us would be able to afford it. You really don’t know how selfish you sound when you complain about less than $2.00 per day for an adult dose. Have you seen the price of some pharmaceuticals these days? I think some are $1000 a month or more.
OSR will be available in capsules, but for now it’s only available in powder form. It has a slight sulfur smell when consumed in water. Add it to juice and it’s no problem to take. Or mix it in some organic peanut butter. Also, at this time no measuring scoops are available yet. 100mg is about 1/16 tsp. Half this dose for people 55lbs and under.
As soon as Haley sends me his article I will try to scan it on this site.
My website is www.totalmouthfitness.com. Click on news, then call my staff if you would like to buy some. May God Bless, Paul G Wilke DDS — Autism Speaks, July 26, 2008
I called Dr. Wilke’s office on July 29 to inquire about the composition of OSR, and was informed by a staff member that Prof. Haley “invented it in his kitchen.” She was unable to provide any information about its chemical composition; rather, she encouraged me to contact CTI Science directly by email.
Also on July 29, an email purportedly authored by Prof. Haley circulated on the ChelatingKids2 list on Yahoo!, AutismWeb, and the Autism Speaks message board.
To All Parents:
We make no claims that OSR can treat any disease or cure any illness. OSR stands for Oxidative Stress Relief which is based on our initial observations that taking OSR increases plasma glutathione levels significantly. OSR has been extensively tested by 3rd party FDA certified toxicology laboratories and no toxic effects have been observed in rats at OSR levels 100 to thousands of times greater than we recommend be used in humans. Also, 3rd party labs have reported that OSR is non-mutagenic, has a good ORAC (oxygen radical absorbance capacity) score and had no effect on pregnancy outcomes when given to pregnant rats in massive doses. We have no indications of any toxicity that can be caused by OSR even at very high doses—which are not recommended. We have fulfilled the FDA new dietary ingredient requirements regarding support of its safety, however, the FDA has not evaluated our position that OSR is an effective antioxidant and a useful dietary ingredient.
OSR is an antioxidant that has the ability to partition into the lipophilic (fatty) tissues of the body and to scavenge damaging free radicals. OSR seems to be of value for a safe process to help in a dietary way those who are suffering from inflammation and oxidative stress. Just being able to scavenge the free radicals (which are the damaging chemicals produced in inflammation) seems to allow the body to salvage much of its reduced glutathione (GSH) most likely causing the increase in body GSH levels. GSH is used for detoxing the body of many toxicants and to protect enzymes from oxidation. I personally have been taking the compound for about 1.5 years and my latest physical showed no abnormal blood chemistry and I have zero physical problems. My personal plasma glutathione levels (LabCorp) was 1,225 with the average index being 669.
CTI Science is a beginning company and cannot make enough OSR at this time to supply everyone that wants it. Therefore, we are only supplying OSR to MDs or ODs who are treating autistic children. This is also being done to make sure that nothing out of the ordinary happens with a minority that may be sensitive to any sulfur based antioxidant, including OSR. It is important to have a physician monitor these children as a precautionary principle. Also, I don’t want OSR to be another “pig-in-a-poke” for parents that does not work. Therefore, we are asking all initial users to agree to allow their physician to get before and after (two months later) testing for 3 items: 1. Plasma glutathione level, 2. Urinary prophyrin profile, 3. CRP levels. This testing will tell a parent if their child needs attention to oxidative stress or specific toxicities or if they are under inflammatory stress. It will also tell them if the OSR did any good with regards to helping alleviate the oxidative stress. Please contact your physician to see if they are aware of OSR if you are interested in trying it. Please understand, I just don’t have the time or the amounts of OSR to send out individual bottles to parents at this time, but I will accomplish this in the near future.
Boyd Haley — ChelatingKids2, July 29, 2008
It appears that OSR has found its way from Prof. Haley’s Kentucky laboratory to Dr. Wilke’s Texas office, then into the body of at least one autistic child.
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. We are taking 1/16th of a teaspoon (50mg) twice daily. Both his behavior and energy level seem unchanged at the moment. Going to gather urine tomorrow (perhaps a 6 to 12 hour collection) to see if there will be any metal pulls. Just thought I would let everyone know. For those of you interested in buying it, I purchased it through a Dentist named Wilke in Texas. It was a whopping 350 for a 6 month supply. Who knows. I know I am swinging for the fences a bit but I felt like taking it low and slow for a while on this, capture some data, pay close attention to my child, and see if this “antioxidant” chelator is up to the hype. Below is the url for OSR. Good luck! — ChelatingKids2, July 30, 2008
Prof. Boyd Haley enhances his credibility by virtue of his affiliation with the University of Kentucky. He routinely notes his status as a faculty member, including in the Autism One presentations described above, and in his submission to the FDA. He makes no apparent distinction between his university-sponsored and private endeavors.
I therefore ask — does the University of Kentucky sponsor, sanction or benefit in any way from Prof. Haley’s research and entrepreneurial activities? Does the university condone Prof. Haley’s public comparisons of OSR’s action with FDA-regulated drugs for the treatment of metal toxicity at the same time that he represents OSR to the FDA as a “dietary supplement” — albeit a “dietary supplement” consisting of chemicals clearly labeled “for research and development use only,” one of which has been designated an Investigational New Drug? Does the university condone Prof. Haley’s failure to publicly disclose the FDA’s opinion that the distribution of OSR may well be illegal? Does the university condone Prof. Haley’s apparent plans to conduct uncontrolled post-marketing toxicity studies and efficacy testing on disabled children before initiating any large-scale testing on adults? And is the university’s Institutional Review Board providing any ethical review of Prof. Haley’s studies of the effect of OSR on human beings?
I look forward to your reply.
James W. Tracy
Vice President for Research
311 Main Building
University of Kentucky
Lexington, Kentucky 40506-0302
Ada Sue Selwitz
Director, Office of Research Integrity (ORI)
315 Kinkead Hall
University of Kentucky
Lexington, Kentucky 40506-0057
Research Compliance Officer, Office of Research Integrity (ORI)
315 Kinkead Hall
University of Kentucky
Lexington, Kentucky 40506-0057
Leslie K. Ball, M.D.
Director, Division of Scientific Investigations (HFD-47)
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue, Room 5342
Silver Spring, Maryland 20993
Linda Pellicore, Ph.D.
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, Maryland 20740
Dr. Robert Moore
Compliance and Enforcement Team
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, Maryland 20740
Jennifer Carpenter, Esq.
Office of the Attorney General
Drug Investigations Branch
1024 Capitol Center Drive, Ste. 200
Frankfort, Kentucky 40601
Office of the Attorney General
P.O. Box 12548
Austin, Texas 78711-2548
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)