A Fine White Powder · Aug 1, 12:00 PM

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.

Sincerely,

Kathleen Seidel
http://www.neurodiversity.com

Recipients:

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

Helene Lake-Bullock
Research Compliance Officer, Office of Research Integrity (ORI)
315 Kinkead Hall
University of Kentucky
Lexington, Kentucky 40506-0057

cc:

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.
Senior Toxicologist
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

Comments


  1. That is a darn good report Kathleen. We shall have to see how this new substance fares. I can hardly wait until they get the data generated and evaluated along the lines of the secretin studies.

    — Patrick    Aug 1, 01:31 PM    #

  2. Thanks, I tried to make it as complete as possible. Both parents and the University of Kentucky deserve to know what's going on here.

    Here's something ironic: the raw materials for OSR come from Sigma Aldrich — the vaccine manufacturer whose lawyers shredded Haley's testimony in Baltimore.

    — Kathleen Seidel    Aug 1, 01:37 PM    #

  3. Amazing. And where is CBS news? Covering this? Of course not!

    This is so extreme. I hope it leads to Dr. Haley being fired. Who knows what kind of damage is being done to autistic children by parents feeding random, basically untested chemicals to their kids?

    — Ms. Clark    Aug 1, 01:56 PM    #

  4. Bravo Kathleen! Excellent investigative reporting, as always.

    — abfh    Aug 1, 02:06 PM    #

  5. Thank you, Kathleen, especially for the information about what OSR is made of. I wonder if limiting the distribution to DAN doctors, and requiring patients to submit to before and after data gathering, is an attempt to meet the “R&D use” limitation. It would be interesting to see the marketing materials that CTI Science, Inc. sends to doctors.

    The word is that you can make OSR in your bathtub, but after reading the MSDS on Cysteamine hydrochloride, I wouldn’t recommend it.

    This is a fascinating example of viral marketing to a vulnerable group of consumers.

    — Anne    Aug 1, 02:19 PM    #

  6. The scariest part was seeing a parent describe their kid having a “prodigious increase in urination and thirst” and not act as if it was anything to be alarmed about. While I rather doubt “OSR” had anything to do with it, that’s a warning sign of Type 1 diabetes, and the proper reaction should be to get the kid’s blood sugar tested pronto.

    This is one of the biggest problems with “alternative medicine”: even if the nostrums used are harmless, it can result in ignoring real conditions. Here a well-known warning sign of a potentially life-threatening condition is being casually dismissed as an “acceptable” side effect of the nostrum.

    — ebohlman    Aug 1, 02:43 PM    #

  7. An excellent, thorough report (as always).

    I’d change one detail.

    You wrote unproven hypothesis that autism is a consequence of mercury poisoning

    I would have written: thoroughly discredited hypothesis that autism is a consequence of mercury poisoning

    — Liz Ditz    Aug 1, 02:57 PM    #

  8. what are u doing to help our children those who say it cant be done should get out of the way of those who are doing it

    — mara lee canno    Aug 1, 03:39 PM    #

  9. Also, this is disgustingly deliberate deception: “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.”

    “Fulfilled” means nothing more than “We filled out the paperwork”. No mention that the FDA has also NOT evaluated their position that the product is SAFE. Using that bit about “fulfilled . . . requirements” for “safety” as a direct foil in the first half of the sentence is particularly odious. That much deliberate deception counts as a LIE.

    Thank you for your meticulous documentation as always, Kathleen.

    — Evonne    Aug 1, 03:48 PM    #

  10. Make that “NOT validated“. They did evaluate the assertions that the product was safe, and decided not to deem it so.

    — Evonne    Aug 1, 03:58 PM    #

  11. Nice work there Kathleen. Great idea to try to get the university to take some measure of accountability for their academics. I tried to get Queen’s University to take an interest in Deborah Elliot’s contribution to that dreadful Vancouver Sun article. We’ll see how that goes.

    — alyric    Aug 1, 04:57 PM    #

  12. Hey Kathleen

    Do you work for PHARMA???

    Just curious

    — LULU    Aug 1, 04:58 PM    #

  13. Mara Lee: What am I doing? Writing articles like this.

    Lulu: Do I work for SATAN PHARMA? No.

    Thanks to ALL of you for visiting and reading this.

    — Kathleen Seidel    Aug 1, 05:19 PM    #

  14. Kathleen,

    I think lying about your intentions to access a support group for parents who are LIVING a life you have no idea about nor will ever know unless you have a child with autism is disgusting. A parent who seeks out help for their sick child is a much better parent then one who sits back and relies on “doctors” to tell them what to do. You have crossed the line personally and professionally and in my opinion you are no better than someone working at the National Enquirer. Like I said, you will never know what these lives are like unless you LIVE them. May God forgive you for whatever damage this “article” hopefully will not do to an autistic child out there trying to be recovered. God help you.

    — Jess E    Aug 1, 11:26 PM    #

  15. For this lover of good writing and well-referenced arguments, Kathleen, your articles are a true joy. I’m immensely grateful for the work you put in. You could teach most TV and newspaper investigative journalists a lesson.

    — isles    Aug 2, 12:31 AM    #

  16. Dr. Wilke wrote, as quoted, that "My whole family is taking it" — so how is OSR a supplement for autism, if everyone in said Dr. Wilke's family is taking it?

    Regarding those studies one sees about "the costs of autism" — what have paying for such alternative treatments "cost" parents?

    Powerful stuff here, Kathleen, and I don't mean the white powder...

    — kristina    Aug 2, 12:55 AM    #

  17. Does anyone know if any independent testing of the safety and effectiveness of this “product”? Preferably by biologists (Prof. Haley seems to be a chemist). I’m not calling for clinical trials in writing this—far from it! I’m referring to the earlier stage, more basic studies on model systems.

    I have to admit the tests as described don’t inspire confidence. Certainly it’d be good to see details (e.g. peer-reviewed publications) of whatever testing has been done, available to the public well before releasing any of the product to anyone_, with sufficient time for objections to be raised (but it appears it may be too late already).

    Leaving aside independent studies, I looked for publications under Prof Haley’s name. I can only find 3 publications of his in PubMed in the last 8 years. He seems to for all practical purposes have stopped publishing since 1999, while having a reasonable number of papers prior (unless the “extra” publications prior to 2000 are from another Haley BE—PubMed name counts can be confusing that way.)

    While difficult to infer from the paper titles alone, none seem directly relevant to testing the product, although the most recent paper at a pinch might have passing relevance. (I’m not connected to the university server at the moment. I might try look further into this if I have time. But don’t hold your breath!)

    While citing wikipedia invokes the usual issues, the article on Prof Haley includes the remarks “Haley surmises that mercury released from dental amalgams could be a potential cause of autism and Alzheimer’s disease. His findings have not been reproduced and the United States Public Health Service and the American Dental Association reject these claims.” (My emphasis.)

    Thus far, it would appear that there is no (formal) confirmation of his underlying claims, never mind peer-review of the product. (The first point isn’t new to many people here, as the underlying claim is an old saw of the anti-vaccine movement, but I think it needs to be made.)

    That he would distribute something prior to publication of his results/hypothesis for peer review, or independent confirmation, or regulatory approval is less than impressive, to be excessively polite about it.

    Jess E: One advantage of being not involved, yet having expertise in an appropriate science, is that you aren’t as easily swayed by the emotional aspects. (You’ll note this effectively puts your objection on its head, and rightfully I think in this case.)

    — Heraclides    Aug 2, 01:50 AM    #

  18. how is that helping my kid the regular doctors do nothing for him and he is in pain shame on you un experienced pompus fool

    — mara lee canno    Aug 2, 02:16 AM    #

  19. Excellent work, as always. I will be most interested to hear their response to you.

    — varkam    Aug 2, 04:56 AM    #

  20. I wonder whence came his goldfish and rats and whether they were housed in a proper facility with approval for animal testing and oversight by animal welfare bodies. We have laws governing such matters in the UK. Is it different in America?

    Also, if it is only being prescribed through doctors who are collecting data on efficiency and looking for side effects isn’t that a clinical trial? We have laws about that as well.

    — mike stanton    Aug 2, 05:30 AM    #

  21. Heraclides, Prof. Haley’s submission (parts of which are appended to the FDA opinion letter) included a “Histopathology Report by Research Pathology Services,” but this was redacted in its entirety from the published docket file; in fact, most of the submission was redacted because it contained trade secrets and other information for which Prof. Haley has a legal right to confidentiality.

    There’s also a reference in Section 3 of the Premarket Notification to testing conducted by “an independent laboratory, Absorption Systems for MB Research.”

    I’m hoping that some scientists will eventually critique the claims made in the section of the premarket notification entitled, "The B-Cell Hyperplasia Seen in Rats Treated With CT-01."

    — Kathleen Seidel    Aug 2, 07:12 AM    #

  22. Jess, you are mistaken in your conclusions about the manner in which I gained access to the CK2 list. Note that CK2 currently has 5,783 members. You cannot reasonably expect that every one of these 5,783 members will remain silent in the face of evidence that a researcher may have misled federal regulators in an attempt to rush to market an inadequately tested drug intended for consumption by disabled children.

    — Kathleen Seidel    Aug 2, 07:56 AM    #

  23. “I think lying about your intentions to access a support group for parents who are LIVING a life you have no idea about nor will ever know unless you have a child with autism is disgusting. A parent who seeks out help for their sick child is a much better parent then one who sits back and relies on “doctors” to tell them what to do.”

    Actually, listening to doctors who practice science-based medicine is far better than subjecting a child to a seemingly never-ending list of quack treatments.

    — Orac    Aug 2, 12:56 PM    #

  24. Why can’t you neurodiversity people just mind your own business? If my child is sick with major gut issues, food intolerances, latent viruses, etc. Why is it your business to stop me in helping my child get well? I am not trying to change my child, but make her healthy so she can one day function independently in life. How is that your business? And why don’t you realize that these kids have health issues? Why is every odd thing an “autistic” child does just considered a part of the “autism”? Why not find out why the child is smearing feces or pushing on his eyes? Mainstream medicine just chalks it all up to that darn autism.

    It’s my opinion that the kids we’re seeing today do not have Kanner’s autism, but are toxic, sick kids. But your group of lazy, ‘follow the herd’ morons just want to accept the “autism” because it’s so mystical and beautiful. Get your head out of your ass.

    — Michelle    Aug 2, 01:40 PM    #

  25. Michelle said “It’s my opinion that the kids we’re seeing today do not have Kanner’s autism, but are toxic, sick kids.”

    Why does your opinion count? Have you done a proper evaluation of all of the children diagnosed with autism in your area? Did you obtain their educational reports and talk to their doctors? Did you perform the tests of their bodily fluids to check for specific levels of certain chemicals?

    You continued: “But your group of lazy, ‘follow the herd’ morons just want to accept the “autism” because it’s so mystical and beautiful.”

    And how does getting sucked into buying the latest “supplement” that was pushed on a Yahoo group not “following the herd”?

    And you finished with: “Get your head out of your ass.”“

    Is this because we don’t necessarily believe what you believe?

    — HCN    Aug 2, 03:10 PM    #

  26. http://aegisofautism.stripgenerator.com/

    I hope Boyd Haley is fired and has to pay for this error for the rest of his life. Do I understand it that the “h” family is testing out OCR on a 20 month old baby? A diagnosis of autism isn’t even certain at 20 months! The family is using mail order laboratories to tell them if their baby is “mercury toxic”?? I believe that some of Boyd’s biggest fans may turn into people wanting to sue him or worse if OCR harms their children, but I don’t know if he’s liable for destruction of children’s health since this is just a cat chelator. :[ I wonder how badly this stuff is redistributing heavy metals into their brains and how much damage it is doing to their kidneys?

    — Aegis of Autism    Aug 2, 04:39 PM    #

  27. I’m reminded of Dr. Bennett Leventhal’s testimony in Dwyer v. HHS . Tom Powers, an attorney, framed a series of questions as “Do you believe (this)?” and “Do you believe (that)?” Dr. Leventhal, a scientist, did not use the term “believe” in any of his responses. At one point, Powers asked,

    “Do you believe that prenatal thalidomide exposure can contribute to the appearance of autism in some children?”

    Leventhal responded,

    “This is not a matter of belief.”

    Later, Powers asked:

    “I am asking you specifically if you believe that there’s a causal association between these various prenatal exposures and the appearance of autistic symptoms in the children who were the product of those exposed pregnancies. Do you believe that there is scientific evidence supporting that there is a causal relationship?”

    Leventhal answered:

    “As I said to you, I don’t believe. There’s what I know and what I don’t know. I am not aware of, I have no knowledge of, a causal link between rubella and autism. There’s an association but there’s not a causal link to my awareness.”

    The difference in their use of language reflects a fundamental difference in attitude towards the concepts of evidence, proof, precision and certainty.

    — Kathleen Seidel    Aug 2, 04:45 PM    #

  28. HCN, do you really believe there isn’t an “autism” epidemic? How many families did you or your parents know who were affected by autism when you were growing up? As an adult I personally know 6 families with autistic kids. How can that be normal? How can anyone say there isn’t a problem? Better diagnosis? What were all of these doctors doing before? How come they only found one or two out of 10,000 20 years ago, but suddenly they are diagnosing 1 in 150? Are they all misdiagnosing? Do you believe everything the government feeds you?

    [link to Gary Null's "Vaccine Nation" video]

    — Michelle    Aug 2, 04:54 PM    #

  29. Michelle said “How many families did you or your parents know who were affected by autism when you were growing up? As an adult I personally know 6 families with autistic kids. How can that be normal?”

    The plural of anecdote is not data. If you have any science I would be willing to look at that.

    Just a small point: a Gary Null video is not science, nor is it data.

    Why are you defending the selling of an unproven “supplement”?

    She continued “How come they only found one or two out of 10,000 20 years ago, but suddenly they are diagnosing 1 in 150?”

    There is no “all of a sudden”. If you claim that, then you have no understanding of the history of disability policy, statistics, education policy, nor much of anything else. But that is only my opinion based on what you have written.

    She continued “Do you believe everything the government feeds you?”

    Which government? The UK, USA, Denmark, Canada, Japan, and others that have shown through several studies that there is no relationship between autism and vaccines?

    See: [WHO Global Advisory Committee on Vaccine Safety Statement on Thimerosal]
    … “Four independently conducted epidemiological studies investigating associations and frequency of neurobehavioural disorders in relation to vaccination with thiomersal-containing vaccines have been completed in the United Kingdom of Great Britain and Northern Ireland and Denmark.”

    (studies between MMR and autism from several countries)

    By the way, if you have some actual scientific literature showing that the DTaP is more dangerous than diphtheria, tetanus and pertussis, please present that (not videos, not random webpages, not news reports on any media, anecdote, not meeting minutes and other non-peer reviewed sources). Thank you.

    — HCN    Aug 2, 05:19 PM    #

  30. Is this the same product as the cat chelator you reported on just a month or two ago?

    You have done an excellent job in the investigation of this and superb writing. It really scares me to see how eager parents are to use this product.

    I hope your letter works in waking up those folks up at the U of Kentucky. Boyd Bailey is a disgrace to science, and this will reflect on the school.

    — storkdok    Aug 2, 05:26 PM    #

  31. Thank you, storkdok. Yes, it is the same stuff he’s been talking about ever since he registered his new corporation. (I haven’t found a patent yet, but there’s probably a pending application wallowing on some hapless USPTO staffer’s desk, not yet ready for primetime.) I haven’t dug deeply enough into the literature pertaining to veterinary use of cyseteamine hydrochloride to know what kind of use it might have for cats — I know it’s added to poultry feed to fend off some kind of problem — or whether the references to cats originated with reports of Prof. Haley experimenting on his own house cats. There’s more digging to do. And maybe someday, someone with real scientific understanding can critique the scientific portions of Haley’s application . There’s a lot there to chew on if you have the right teeth.

    — Kathleen Seidel    Aug 2, 05:41 PM    #

  32. Do you all really think that Boyd did his clinical trials of OSR only on CATS???

    Not likely. He isn’t that clueless…

    Kathleen you don’t have all of your facts.

    — LULU    Aug 2, 07:26 PM    #

  33. Kathleen, what is your interest in autism and autism treatments?

    — Mike    Aug 2, 07:49 PM    #

  34. I keep telling you to stop being a girl and being the man you really are instead – John!

    Sack Boyd! Sack Boyd! Sack Boyd! Hope you do get a reply, K!

    — Lulu's GF    Aug 2, 08:22 PM    #

  35. Mike, one of my biggest interests has to do with the exploitation of families and mistreatment of children by opportunistic entrepreneurs.

    — Kathleen Seidel    Aug 2, 08:33 PM    #

  36. Mike wrote “Kathleen, what is your interest in autism and autism treatments?”

    Go back and read her blog entry dated May 26th (High Profile for a “New Wave”), and then go back and read the first entry in this blog (it is easy to get to, just change the number in the URL from 168 to 1).

    — HCN    Aug 2, 08:39 PM    #

  37. Lulu, I’m not under the impression that Haley only tested on cats; his submission indicates that he tested on rats, also. And if Dr. Wilke is to be believed, Haley also gave some OSR to goldfish. That doesn’t mean the stuff is safe for humans.

    If you want facts, why don’t you actually read the article in its entirety, and read the FDA docket file, too. I’ve gathered all of the facts that are publicly available at this time, and included links to sources wherever possible. If you have any more to add, I welcome you to share them.

    — Kathleen Seidel    Aug 2, 08:44 PM    #

  38. “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.

    Bloody unbelievable! With testing on some goldfish, maybe some rats, and a senile cat, you are ready to start experimenting on helpless human beings!

    To repeat what I constantly hear from the anti-vaccine crowd: what about the long-term effects? What about chronic toxicity?

    — Tsu Dho Nimh    Aug 2, 09:41 PM    #

  39. How would vaccines do in Dr. Haley’s safety-testing protocol?

    Would the people who are using it on their children agree that passing Dr. Haley’s “the cat is fine” standard is an adequate screen for vaccine safety?

    — D. C. Sessions    Aug 2, 09:49 PM    #

  40. Kathleen, I have been raising Autistic children for over 17 years. I do thank God every day for not letting their be the quackery that exists today when my first child was diagnosed.
    Instead, I got to watch my oldest grow up to be what she should be…with traditional therapies (speech, OT, Play, etc), she has become quite an amazing young woman.
    Thanks to her, we have learned how to raise our other children.
    Thank you for the research. I hope you can keep at least one child from succumbing to the quackery their parent’s are searching for with OSR.

    — Jeanette    Aug 2, 10:16 PM    #

  41. @Mike Stanton-
    If he did any studies on vertebrate animals then Haley would need an IACUC. Check out this pdf of the guidelines by NIH

    If he didn’t then he’d be violating U of Ky policy, state laws, and federal laws.

    — Bartholomew Cubbins    Aug 2, 10:53 PM    #

  42. And a bit more – if he used a standing IACUC somehow related to U of Ky and didn’t have an appropriate protocol, in other words if he just used an old protocol or a buddy’s that was for a different set of experiments, that alone is grounds for dismissal.

    — Bartholomew Cubbins    Aug 2, 11:06 PM    #

  43. “I got to watch my oldest grow up to be what she should be…with traditional therapies (speech, OT, Play, etc), she has become quite an amazing young woman” So much for the commitment to repudiate anecdotal claims. Just how much and what kind of testing would be sufficient to determine safety of OSR? I wonder if it may have effects as a chelator, considering that it’s structure contains 2 thiol groups(due to the bis (2-mercaptoethyl) part of the name of the compound).

    — lurker    Aug 3, 01:02 AM    #

  44. http://www.merck.com/mmpe/sec16/ch223/ch223h.html

    — Diane    Aug 3, 01:19 AM    #

  45. Hi Michelle,

    “HCN, do you really believe there isn’t an “autism” epidemic?”

    I am ready to believe you. Do you have any convicing scientific evidence that there is an autism epidemic?

    “How many families did you or your parents know who were affected by autism when you were growing up?”

    Two. But the definition of “autism” has changed, and the criteria for autistic disorder have broadended. PDD-NOS and Asperger’s were just on their way (which now make up two thirds of ASD’s by the current descriptive epidemiology).

    “As an adult I personally know 6 families with autistic kids.”

    Congratulations.

    “How can that be normal?”

    Compared to what?

    “How can anyone say there isn’t a problem? Better diagnosis? What were all of these doctors doing before?”

    Making occasional diagnoses. They were unfamiliar with autism and autism spectrum disorders (since the concept of autism as a spectrum of disorders didn’t even exist).

    “How come they only found one or two out of 10,000 20 years ago, but suddenly they are diagnosing 1 in 150?”

    Do you have a citation to support “one or two out of 10,000”? And, there is no suddenly. Are you completely unfamiliar with all the changes in the definition and criteria for diagnosing autism spectrum disorders?

    “Are they all misdiagnosing? Do you believe everything the government feeds you?”

    Yes. The government is the creator of ultimate truth. Science is meaningless. Statistics are meaningless. If it comes from the CDC, it might as well have been cast down from the heavens. Everyone knows the government controls nature and the physical laws of the universe. Science is the guvmint’s biatch.

    — Freddy    Aug 3, 01:54 AM    #

  46. great research! you will, unfortunately be seen as a naysayer but experience shows that chelators are dangerous and caution is needed with this new chelator.
    i have put a link to your post on my chelation page

    — Andrew    Aug 3, 04:28 AM    #

  47. Kudos on yet another masterpiece of investigation, Kathleen.

    — Dave    Aug 3, 08:30 AM    #

  48. What bothers me the most about OSR is that the product is being sold, by doctors and dentists, as being “FDA Approved”.
    If you call the FDA, they will tell you it is a Food Supplement, therefore does not need FDA Approval.
    It still amazes me what naive parents will purchase for the sake of a “cure”….Scary Stupid.
    But, I am thrilled about a particular parent who is ingesting the product….maybe it will kill the bug up her butt.

    — Jeanette    Aug 3, 07:18 PM    #

  49. Kathleen…I don’t think that you would be writing a rant like this if you had autism the way my nephew and son have autism…with a side order of Inflammatory Bowel Disease (with debilitating arthritis for my 12 year old son), Tourette’s, and seizures (all diagnoses associated with autism.) They are very much like you except that they get to look forward to multiple surgeries, debilitating seizures and making embarrassing movements in public for the rest of their lives (which unfortunately will most likely be shorter than most.)

    So what do you choose to do with your life? Obviously you are a very intelligent person. Perhaps you could sacrifice your career (in many ways) and work countless hours doing research to look for something that will help sick children’s and adult’s bodies work better so that their bodies can heal themselves?

    Or…ummm…Perhaps you could spend your life raging against people like Boyd Haley, that while they have no personal stake in autism, just want to help these sick people who are like, but unlike yourself.

    You choose what you will do with your life…oh wait…you already have.

    — CC    Aug 3, 11:57 PM    #

  50. CC,

    As I wrote earlier being one-step removed can help you have a more unbiased view on things.

    Your little diatribe reads as ironic to me on several points including that you hold Boyd up for being, in your eyes, independent, yet put Kathleen down for the very same thing.

    Boyd is the President of the company selling the “product”, not an independent advisor to it, or “merely” an independent scientist granting rights to use his invention under license or whatnot. With that in mind he isn’t independent as you say; in fact this was one of the points that Kathleen was making.

    — Heraclides    Aug 4, 06:12 AM    #

  51. CC, thank you for visiting and for reading even part of what I’ve written. I’m guessing you’ve only read enough of my letter to gather that I am critical of the actions of someone you look upon as a hero. If you read all the way through, you may see that I am motivated by the same concern that motivates those who are critical of "Big Pharma" — i.e., concern over the need for adequate testing and accurate labeling of pharmaceutical products.

    "Little Pharma" needs to play by the rules, too.

    I wish you and your family well.

    — Kathleen Seidel    Aug 4, 06:27 AM    #

  52. Michelle writes:

    “Why is it your business to stop me in helping my child get well?”

    Others include similar sentiments in their comments.

    My question is this: how does reporting the facts stop someone from helping their child? I would think that knowing ALL the facts would HELP rather than HINDER someone in their quest for the best treatment for their autistic child.

    FACT: Boyd Haley is selling a new chelator (OSR) to the public.

    FACT: This new chelator is being marketed as a “dietary supplement” even though it doesn’t meet even the common-sense definition of a “dietary supplement”. It is not DERIVED from a food item, nor is it a “vitamin”, a “mineral” or an extract from a food item. The only reason I can imagine to explain why Dr. Haley would be using this route is to bypass the FDA regulations for new drugs.

    OSR meets the common-sense definition of a “new drug” in that it is a synthetic compound that does not exist in nature and is not simply a new method of administering a previously approved drug.

    Nor is it a drug – like aspirin – which was in widespread use prior to the establishment of the FDA.

    FACT: Some of the people selling OSR do not make it clear to their patients/customers that this DRUG has not been tested to anywhere NEAR the standard for a new drug.

    FACT: The FDA, in its opinion, states that OSR should not be simply expected to be safe and needs further testing.

    The FDA is unable to do anything further because the DSHEA bars them from requiring anything more than a notification from Dr. Haley that he intends to market this DRUG as a dietary supplement. Imagine the chaos if Merck or Lilly decided that they were going to market their newest drug as a “dietary supplement” in order to save the money it costs to meet the FDA “new drug” standards.

    FACT: People who take this DRUG or give it to their children are taking a significant risk. It may well turn out that OSR is as safe as table salt – and I hope, for the sake of the children who have already received it, that it is – but it could ALSO turn out to be the next thalidomide. A few studies on rats (and, apparently, goldfish) will not reveal that sort of delayed or subtle toxicity.

    In essence, every person who takes (or is given) OSR is taking the place of laboratory rats who SHOULD have been used to test this DRUG.

    Prometheus

    — Prometheus    Aug 4, 11:28 AM    #

  53. Kathleen said: Mike, one of my biggest interests has to do with the exploitation of families and mistreatment of children by opportunistic entrepreneurs.

    Hi again Kathleen. Your stated interest is indeed a noble pursuit, I just hope you are doing it for the right reasons.

    I’ve met a few kids now who are no longer autistic thanks to some of the “quackery” that gets dealt with so harshly by some of the posters on this site.

    I really hope some of the resentment expressed towards these treatments and improving children does not come from some deep psychological guilt of parents who have done nothing but slander what others do.

    — Mike    Aug 4, 07:45 PM    #

  54. Take this – aimed at the HPV vaccine Gardisil: “Merck has demonstrated that they are more than willing to gamble our children’s health on an unproven vaccine in return for immense profits. This magnitude of evil is rare, even for a drug company.”(from VACCINES, “The HPV Scandal” by Dr. Julian Whitaker)

    It becomes this: “Boyd Haley has demonstrated that he is more than willing to gamble our children’s health on an unproven drug in return for immense profits. This magnitude of evil is rare, even for a drug company.”

    — Tsu Dho Nimh    Aug 4, 08:51 PM    #

  55. Mike said “I really hope some of the resentment expressed towards these treatments and improving children does not come from some deep psychological guilt of parents who have done nothing but slander what others do.”

    All you have to do is show that the treatment really works, and is based on good science. Show us which quackery worked, with good documentation of the child before and after.

    This has not been demonstrated with this latest nostrum.

    All we ask is for some real science. Is that too much to ask?

    — HCN    Aug 4, 08:57 PM    #

  56. NAC is also very mobilising of heavy metals and i have seen plenty of brains ruined by it over the years

    large doses of MSM also have a very bad effect on brain neuron trees

    real science is nice in theory but a lot of the research about is very low quality and since the area of interest is so large, its just not there and you have to make use of your own observations and reading or you can be killed

    — Andrew    Aug 4, 09:47 PM    #

  57. “HCN, do you really believe there isn’t an “autism” epidemic? How many families did you or your parents know who were affected by autism when you were growing up? As an adult I personally know 6 families with autistic kids.”

    I actually didn’t know anyone growing up. I mean I didn’t know them by that label. It wasn’t until the late 1990s that I found that I’m autistic. Later I realized my dad is autistic, that my two brothers are possibly autistic, and that a cousin is autistic. My wife’s dad, also apparently autistic. And of course, I have a son who is autistic. I did know I had an uncle with mental retardation. I can tell he’s actually Fragile X, never tested for it. I have an aunt with Schizophrenia. She could’ve easily been called autistic too.

    It’s really not possible, statistically, for large families to not have members with mental disabilities. Just from IQ distribution, 3% of the population will have an IQ below 70. About 15% will have an IQ below 80. Anyone who claims their family is perfect is either lying, or somehow the disabled family members had been sent away and forgotten.

    — Joseph    Aug 5, 11:22 AM    #

  58. “I’ve met a few kids now who are no longer autistic thanks to some of the “quackery” that gets dealt with so harshly by some of the posters on this site.”

    If you look on the web, you will see that there are several testimonials about autistic children who have been “cured” by Homeopathy. In your view, is this a good basis to reconsider the claim that water has memory?

    There’s a reason why science matters, especially when it comes to autism. Up to 20% of autistic children diagnosed at age 2 will lose their label by age 7. No one knows why. It’s kind of like asking, “why do normal children begin to speak? what causes it?”

    Obviously, many of those children will have tried a variety of treatments (including homeopathy and others) and their parents no doubt attribute the loss of label to those treatments.

    About 13% of Kanner’s patients, at a time when the word autism was virtually unheard of and there were no autism interventions whatsoever, had a successful outcome.

    — Joseph    Aug 5, 11:47 AM    #

  59. Joseph said “If you look on the web, you will see that there are several testimonials about autistic children who have been “cured” by Homeopathy. In your view, is this a good basis to reconsider the claim that water has memory?”

    I have read about one parent pushing homeopathy as a “cure” for her son’s autism. Though as I dug deeper I found out that the child was never formally diagnosed as autistic.

    This is why I would have to see real evidence of a child who was given a good formal diagnosis from qualified evaluators, then given the stated “quack treatment” without any other standard therapies (speech therapy, occupational/physical therapy, educational therapies)… and then re-evaluated again by qualified persons.

    By the way my experience is having two sons who both had language issues as two-year olds.

    The oldest still had not real speech by age three and needed over ten years of speech therapy starting at age two and educational supports (starting with a specialized preschool). He is still fairly disabled and attends community college with disability services. (note: he also had a history of seizures starting at age 48 hours, a year on anti-convulsants, and last seizure at age 15 months during an illness)

    The younger boy did get language therapy starting at age three (he had been officially diagnosed with dysphasia, an actual “late talker”), but tested at “low normal” within two years, and has never required any special education services. He is now a high school honor student and works as a lifeguard.

    If I had used any Bradstreet nostrum or other chemical additions on both boys, then one would conclude that I did not do it right for the first one… and that it worked for the younger boy.

    But I did not. I took my boys to real speech language pathologists and a very good child neurologist… plus a very good school district.

    — HCN    Aug 5, 12:11 PM    #

  60. “It’s really not possible, statistically, for large families to not have members with mental disabilities. Just from IQ distribution, 3% of the population will have an IQ below 70. About 15% will have an IQ below 80. Anyone who claims their family is perfect is either lying, or somehow the disabled family members had been sent away and forgotten.”

    Large families aren’t comparable enough to the whole population. I wonder to what extent that the genetic similarity in large families could constrain the level of variation in intelligence among those family members.

    — lurker    Aug 5, 05:42 PM    #

  61. lurker wrote:

    “Large families aren’t comparable enough to the whole population.”

    While they might possibly more frequently have parents conceiving at an older age, I would think that once corrected for this I would think that those from large families are largely (pun intended) biologically the same as the rest of us.

    There is an association of (relatively!) advanced age at conception and various developmental and neurological disabilities in off-spring.

    A point here is that if this were the issue, its not the family size itself that would matter, but the age of the parents at conception. (I’m not familiar with the actual distribution of conception ages in large families compared to the population as a whole, so this argument is hypothetical—my point about the association of age of conception and disabilities in offspring isn’t however.)

    “I wonder to what extent that the genetic similarity in large families could constrain the level of variation in intelligence among those family members.”

    The size of the family has no bearing on genetic similarity of the offspring—I suspect you are confusing family size with inbreeding, which does have a bearing on this.

    — Heraclides    Aug 5, 08:00 PM    #

  62. Boy, shining a light on Boyd Haley sure brings out the righteous fury in some people. It’s as if they cherish their right to pay large sums to play roulette with their kids’ safety.

    — isles    Aug 5, 09:03 PM    #

  63. the problem with chelation is subtle because it often gives good results to start with which you might expect from “oxidative stress release” which most chelators do to some extent.

    however long term you have the problem of increasing cumulative damage to the brain, thyroid and kidneys and this can take six months or a a year to become very obvious which is apprently what is required for most parents to realise that all is not going well.

    getting sustainable, minimally heavy metal mobilising and damaging, “oxidative stress relief” is what the compendium™ and bcd™ are all about

    however a complex dietary and supplement approach seems not be in favour even though its all that works and the slow erosion of certain doom from sought quick fixes and nutty medicalization holds its devotees in thrall…………..

    — Andrew    Aug 6, 02:09 AM    #

  64. The problem with chelation (and other “alternative” therapies) is that it’s hard to distinguish them from placebos.

    Like most placebos, the initial results are often much better than the long-term effects. And, as with most placebo “effects”, once they “wear off”, they rarely occur with the same “therapy” again.

    “Dietary supplements” are – more times than not – simply a “kinder, gentler” way of promoting medical quackery. Whether it’s “Dr. Floyd’s Vegetable Elixer” or “Biofilm Carbohydrate Diet”, if it doesn’t have anything other than testimonials (or “narrative data”, the modern equivalent) to support it, it’s all just a bunch of “Just So Stories”.

    Now, if you have some real data…..

    Prometheus

    — Prometheus    Aug 6, 06:23 PM    #

  65. prometheus, a person of sense wrties with regard to what is true or not, not just some aggressive spin up

    — Andrew    Aug 6, 06:52 PM    #

  66. POST FOR: Kathleen Seidel

    BY: CK

    RE: “OSR”

    DATE: 8-6-2008

    Dear Kathleen, I have read your Bio here, and I still cannot clearly determine how you (and/or your husband) actually earn a living and how you support your family financially.

    So, I ask you, how exactly do you (& your husband) earn a living and support your family financially?

    I am asking you this so that we may determine here that you (& your husband) do not have any livelihood-type dependencies and/or do not have any financial income stream that would be threatened by the success of a product like OSR.

    In other words, do either you or your husband earn a living and/or receive a financial income stream that would be jeopardized by the success of a product like OSR?

    I think that this question to you is only fair, since you are making an inquiry via your letter here if the:

    University of Kentucky sponsors, sanctions or benefits in any way from Prof. Haley’s research and entrepreneurial activities.

    Also, what are you doing to help your own ASD child treatment-wise, and how severe is your own child’s ASD disorder? What progress do you have to show with the treatment of your own ASD child?

    Finally, why do you not just wait and let people try the OSR product for a while to see if it actually works before you trash it?

    After all, certainly you would have a much stronger case for trashing this product (that is how I would characterize your letter here, trashing the OSR product, trashing Boyd Haley, and trashing Paul Wilke) if you first waited a while to see if this product will be shown by its use by the public at-large to mostly be an ineffective dud.

    More simply put, why are you making such a grandiose near-missionary-zealous attack on this product (with this letter and this letter’s U of K recipients and governmental agency cc’s) NOW, while the public-at-large jury is still out on this product??

    Your actions here (this letter) just seem premature to me.

    For the record, I plan to use the OSR product myself (I have already placed my order) to see if it can effectively detox Mercury, which I have multiple-test-verified that I have excess levels of.

    I will be doing an ongoing tracking of the efficacy of this product via Urinary Porphyrins testing of myself. FYI, Urinary Porphyrins testing is the most advanced test yet devised for testing the total body burden (total load) of systemic Mercury in humans.

    It will really be quite simple for me to verify the efficacy of this product; if the levels of my Urinary Porphyrin markers for Mercury go down, then the OSR product works. Very scientific, I think.

    I will also be closely monitoring your ongoing attack on this product, and I will ongoing be trying to determine why you are spending so much of your own personal time & effort attacking this product at this time, especially from the standpoint of what you may potentially personally/financially stand to gain by trashing this product and what you may personally/financially stand to lose from the success of this product.

    I will look forward to your answers to my questions posted here.

    Sincerely,

    -CK

    — CK    Aug 6, 07:53 PM    #

  67. “It will really be quite simple for me to verify the efficacy of this product; if the levels of my Urinary Porphyrin markers for Mercury go down, then the OSR product works. Very scientific, I think.”

    no, the question is, does the mobilised mercury or other heavy metals cut any large scale neural structures in the brain and long term do any kidney or thyroid problems develop

    my observations over the years is this always happens with chelation

    in my view boyd haley has been adversley affected by his year and a half trial of OSR

    — Andrew    Aug 6, 08:23 PM    #

  68. A few comments on the article and the comments thus far. The assumption that FDA approval equals safety or even good sense is just that, a big-assed assumption.

    An unrelated but important topic that Kathleen might like to investigate next is HRT. Premarin was FDA tested and approved. When the women’s study came out the data showed that equine estrogen increased the risk of estrogen sensitive cancer. Not a total surprise, horse estrogen is a quite different molecule than human estrogen. Plus it had to be given to women in whopping doses in order to achieve symptomatic relief of menopause symptoms, because it wasn’t human hormone, it was an analog. With this news Wyeth instantly lost billions in annual sales as scared women dropped the product for good. FDA did not pull Premarin from the market. Wyeth, Premarins owner’s move? to petition the FDA to ban compounding pharmacies from filling physician&