An Inquiry Emerges · 2008-08-14 20:00

Yesterday, I received a response to my August 1 letter to University of Kentucky administrators regarding Prof. Boyd Haley’s development and marketing of Oxidative Stress Relief, or OSR — a minimally-tested chelation drug of unknown toxicity to humans, recently entered into interstate commerce under the guise of a dietary supplement and marketed for consumption by autistic children allegedly suffering from heavy metal toxicity.

August 13, 2008

Dear Ms. Seidel:

This is to acknowledge receipt of your e-mail message of August 1st. We continue to review the situation, and will consider whether or not the University of Kentucky has any involvement. In any event, we will ask Dr. Haley to avoid using the university’s name in any matters involving his activities with an outside company.

I have asked several offices to review your e-mail message and the various hyperlinks you include. Please be assured we take your concerns very seriously, and will give them careful consideration.

Sincerely,

James W. Tracy, PhD
Vice President for Research
University of Kentucky


The following is my reply.

August 14, 2008

Dear Professor Tracy,

Thank you very much for your reply and your willingness to investigate the matter of Prof. Boyd Haley’s chelator-cum-“antioxidant” Oxidative Stress Relief (OSR). Since I originally wrote to you and your colleagues two weeks ago, additional information and questions have arisen about the origins of OSR, and about the role and responsibility of the University of Kentucky in its development and licensing.

1. Molecules which Prof. Haley has described at autism conferences as “chelators” and “antioxidants” are identical to molecules developed by University of Kentucky Prof. David Atwood and encompassed by U.S. Patent 6,586,600, “Multidentate Sulfur-Containing Ligands” (.pdf). The patent is assigned to the University of Kentucky Research Foundation. The chemical structure of one patented molecule, BDETH2, as described in Prof. Atwood’s Powerpoint presentation, “Heavy Metal Binding With Thiolate Chelates,” is identical to the chemical structure of OSR as described in Powerpoint presentations by Prof. Haley. Prof. Atwood’s Powerpoint presentation indicates that BDETH2 is toxic to minnows at 292 ppm — significantly more toxic than ethylene glycol (see p. 11). The chemical structure of a pyridine-based molecule described in Prof. Haley’s Powerpoints is identical to the structure of “PyDET,” a pyridine-based chelator also encompassed by Patent 6,586,600 and described in Matlock, Atwood et al.‘s 2002 paper, “Effectiveness of commercial reagents for heavy metal removal from water with new insights for future chelate designs.” It is clear that both BDETH2 and PyDET are synthetic compounds that do not exist in nature, they are not derived from foods, and are not synthesized versions of naturally-occurring compounds. Neither BDETH2 nor PyDET has a CAS number or a Materials Safety Data Sheet. Neither BDETH2 nor PyDET nor any derivative thereof can honestly be described as a “dietary ingredient” or a “food supplement.”

2. The University of Kentucky Office for Commercialization and Economic Development identifies Prof. Haley and “Haley Tech” as recipient of a startup license in 2007 for development of water soluble chelators. The university website offers no further information regarding the sort of applications for which Prof. Haley d/b/a/ Haley Tech was granted his license, or whether that license extends to the operations of either Prof. Haley’s Chelator Technologies or CTI Science business entities.

3. It has been reported that in addition to the rat toxicity studies described in Prof. Haley’s FDA submission, Prof. Haley has conducted experiments on OSR on goldfish, his own cat, and cats belonging to another family that were poisoned by melamine. It is unclear whether protocols for these pharmaceutical experiments on vertebrate animals have been approved by any Institutional Animal Care and Use Committee.

4. On August 30, 2005, Texas dentist and OSR distributor Paul G. Wilke, DDS was sanctioned by the Texas State Board of Dental Examiners regarding multiple instances of failure to obtain proper informed consent from a patient. According to SBDE Order No. 04-524-0308:

“During the time period from June 26, 2002 through September 26, 2002, the Respondent fell below the standard of care by failing to make, maintain, and keep adequate dental records on patient O.M. Specifically, the record does not include: a written informed consent signed by the patient for the administration of anesthesia on multiple occasions; or written informed consent for extractions performed on June 26, 2002 and July 16, 2002.”

Presumably, Dr. Wilke has satisfied the terms of his settlement agreement (i.e., payment of a $500.00 fine and completion of continuing education courses in crown and bridge procedures, risk management and recordkeeping). Nonetheless, his disciplinary history and his unprofessional demeanor in the direct-to-consumer sales pitches he has broadcast on Autism Speaks inspire little confidence in his competence to participate in an informed consent process involving OSR consumers, especially those who are not his patients.

After being publicly criticized for stating that “OSR was approved for sale by the FDA in July of 2008,” Dr. Wilke removed the statement from his website (compare this .pdf of the original version). However, his admonition to parents to “Be thankful that OSR was FDA approved and is available” remains viewable on the Autism Speaks message board.

Since you have expressed your intention to explore all of the hyperlinks contained in my previous letter, and since only registered members can access the ChelatingKids2 list on Yahoo!, I have attached .pdf files of several list discussions and posts so that you can verify the quotes and get a better sense of parents’ understanding of the purpose and function of OSR.

Also, since Autism Speaks has announced that it plans to close its message board in September, I have created and have attached .pdf’s of Dr. Wilke’s posts to that forum.

I have published my August 1 letter to you and your colleagues online under the title, “A Fine White Powder.” A second essay, “The Industrial Treatment,” discusses the University of Kentucky patent. I encourage you to read the public comments appended to this material, which include the observations of chemists, doctors, a former FDA fraud investigator, parents of autistic children, and autistic citizens. They offer a range of perspectives on the scientific and ethical implications of Prof. Haley’s development and testing of OSR, and his unconscionably premature and misleading marketing of this drug to the families of vulnerable disabled children.

Best regards,

Kathleen Seidel
neurodiversity.com | honoring the variety of human wiring


2010 UPDATE

All articles about OSR on Neurodiversity Weblog:

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

Articles about OSR in The Chicago Tribune:

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

Comments


  1. Watching you practice accupuncture is a thing of beauty. Skewer on.
    Robert

    — Robert Estrada    2008-08-15 14:37    #

  2. Maybe Haley thought no one would mind that he was cooking stuff up in his house and selling it under false pretenses to people who are down to their last dollars but willing to try anything.

    I’m hearing the Wonder Woman theme again…

    — isles    2008-08-15 17:47    #

  3. Well said, as usual.

    What I wonder about is how it is that Atwood’s research indicates that one of his chelators kills half of minnows exposed to 292 ppm but Haley’s “goldfish” survived. So did Haley give the goldfish much less that 292 ppm? and why would it be that Goldfish would be so much more impervious to MetX and PyDet than minnows would be. It only took 12 ppm to kill fleas, as I recall, making PyDet or MetX (or OSR) a potent little flea killer, it would seem, though maybe I’m not understanding minnow and flea toxicology.

    — Ms. Clark    2008-08-15 18:31    #

  4. Dr. Wilke’s new ad reads like this:

    **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 dramatically raises levels of glutathione (GSH) in the body. GSH is a powerful antioxidant which reduces oxidative stress, inflammation and helps to remove heavy metals.

    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.

    OSR is available for patients of Total Mouth Fitness. **

    — Jeanette    2008-08-18 09:39    #

  5. The marketing of “OSR” as a “dietary supplement” makes it all too apparent that the DSHEA has put a massive loophole in the FDA’s ability to regulate drugs. All Boyd Haley had to do was call his new drug a “dietary supplement” and – like magic – it’s no longer a drug. And the FDA is powerless – thanks to the DSHEA – to do anything about it. To people who feel that the FDA has let them down, this may seem like some sort of victory, but it’s really a defeat for the public at large.

    Clearly, Boyd Haley’s “OSR” is a DRUG. I haven’t heard/read anybody arguing that “OSR” meets the DSHEA definition of “dietary supplement”, so it seems obvious that even his supporters are aware that this is nothing more than an “end run” around the regulations that were put in place to protect the public from inadequately tested drugs.

    I’ve heard how Dr. Haley wanted to save time and money and get his “next generation” of chelators to “the people who need it”. It’s a touching story of a selfless scientist who wants to “do the right thing”. It’s also a story of amazing hubris, where a scientist thinks that he knows more than anyone else and is determined to carry out his plans, come what may.

    It’s also been touching to read the comments from parents who have “faith” in Dr. Haley – so much so that they are willing to accept his assurances (in the face of inadequate data) that OSR is safe and effective. I sincerely hope that their trust is not misplaced. I sincerely hope that their story won’t some day be read as a cautionary tale of how the pursuit of false hope can lead to real calamity.

    I anticipate that Haley’s success in getting a drug to market by calling it a “dietary supplement” will prompt other would-be pharmaceutical entrepreneurs to put their drugs into the “dietary supplement” market, as well. Let’s all hope that MS&D, Lilly, Pfizer and other members of “Big Pharma” don’t decide to save billions of dollars and market their next development direct to the public, courtesy of the DSHEA loophole.

    I await the University of Kentucky’s response to this legal but unethical manipulation of DSHEA. I hope they will “do the right thing”, but I have little expectation that they will. More likely, the whole matter will get tied up in legal wrangling and “due process” and little or nothing will be done, apart from generating reams of legal briefs.

    Meanwhile, all of the autistic children and “mercury toxic” adults who use this drug will be acting in place of the rats, hamsters and guinea pigs who would otherwise be doing the dangerous work of product safety testing. Good luck to them all.

    I hope this story has a “happy ending”, but I don’t think that it will. This scenario has more similarity to a Greek tragedy than a “happily ever after” story.

    You have the “hero”, consumed by hubris, convinced that he knows what is right, marching boldly to disaster. You have the FDA, playing the role of the chorus, warning the “hero” of his impending doom – and the hero unable to hear it. Of course, you also have the “ensemble” – the children who will suffer and the anguished parents who will be the instruments of Fate in the downfall of the “hero”; first encouraging him to over-reach and then punishing him when he fails.

    I hope I’m wrong about this, I really do.

    Prometheus

    — Prometheus    2008-08-20 15:32    #

  6. Prometheus, this seems more like the sort of situation your brother, Epimetheus, would get into. His motto is, “On second thoughts, maybe this wasn’t such a good idea.”

    Like you, I really hope this doesn’t turn into a major disaster for a lot of innocent people.

    — LW    2008-08-20 17:53    #

  7. we need to know what is in the new product osr. what are the side effects?, i have a little girl with autism but also epilipsy , will this cause problems or damage the liver.

    — caroline    2008-11-19 12:38    #

  8. I want to respond to this as someone who knows both about the supplement business and specifically about some details of Dr. Haley’s supplement. As the owner of www.jigsawhealth.com I had discussions with Boyd about Jigsaw being the marketing company for the new supplement. It was decided that we would not market the supplement as he wanted to do it himself which was fine. But we would have marketed it very differently than he has chosen to do. But he is well within his rights to market as he is.

    As part of our due diligence we submitted everything that was known about the ingredients to our lawyer who specializes in supplements and the FDA. We also submitted the same info to our consultant who advises us regarding FDA and DSHEA rules and regulations. After analysis they both advised us that there was absolutely no reason why it could not be marketed as nutritional supplement as long as we proved it’s safety and submitted that info to the FDA.

    This is also not unlike the thousands of chemicals that get a GRAS (generally regarded as safe) designation. Aspartame and MSG are in this class. Both have demonstrated strong negative effects in some humans and yet they are GRAS.

    First, 100’s if not 1,000’s of new supplements, many with very unique ingredients are introduced every year using the exact procedure that Haley
    used with his new supplement. All that is required is to provide evidence of safety to the FDA. Efficacy does not have to be proven. They have 75 days to study your submission. If they do not ask for more proof, you have the right to market that supplement. Dr. Haley did exactly that. In fact, I thought he went way overboard with the number of different tests that he ran on the supplement to prove it’s safety. He hired a couple of different firms who determined that it was extremely safe and determined LD 50. Meaning what dose is required to kill half the test subjects (obviously not done with human subjects). As I understand it, it was determined that there was no dose that would kill any of the subjects. It was proven to be very safe. I can confidently say, Dr. Haley was more far more thorough than was needed.

    I believe it is unfortunate that he decided to market it as an antioxident. It is a mistake because it makes it appear he is not being straight forward. Fact is, the supplement is high in glutathione which is in fact an antioxident. So he is correct.

    My interest in the supplement was the fact that it clearly demonstrated strong chelation properties specifically for mercury. I won’t go into the details because I think it would be inappropriate for me to do so. But the experiments done by Dr. Haley were nothing short of amazing and I personally saw what he and his assistant did.

    If it were Jigsaw, we would market it very clearly as a supplement that does remove mercury from the body. And we would have the clinical proof that it does do this.

    Now, this does not make it a drug. It could be a drug though there are many reasons why Dr. Haley would make the decision to market it as supplement instead and there is no question in my mind he made the right decision.

    First is cost. The process to make it a drug costs a minimum of $300 million and takes years. The only real advantage to pursue this as drug is that Haley could then have patent protection and could specifically state that it could treat mercury poisoning, a disease condition.

    Under DSHEA, supplement companies cannot make disease condition claims. They can only say that an ingredient “may” support a particular system of the body, like the cardiovascular system as an example.

    I know that Dr. Haley was very concerned about saying the supplement had anything to do with mercury because he has been so closely associated with this controversy for so many years. So he decided to market it as an antioxidant, which in fact is true.

    Truth is, he could market it as supplement that “removes mercury from the body.” This is NOT a disease claim. It is a function claim. Function claims are allowed under DSHEA as long as they are true. Dr. Haley has direct and powerful proof that the supplement does in fact remove mercury from the body. I personally think this is how Dr. Haley should market the product. The way he is doing it opens him up to exactly the kind of criticism that he is getting here and elsewhere. I believe if he marketed it with a straight function claim using the clear and reproducible proof that he has, he would be much better off and actually on more solid ground both scientifically and marketwise. And under DSHEA he would be well within his rights as long as he does NOT make any disease claim, like it “cures autism,” or “mercury poisoning”, or “prevents Alzheimers” etc. That would absolutely be a violation of DSHEA.

    As it is, his choice to market it as an antioxident is accurate. But I don’t think it is the best way to market what he has. But he is well within his rights and he has followed the exact FDA procedure required. In fact, he far exceeded their requirements.

    Pat Sullivan

    — Pat Sullivan    2008-11-22 23:56    #

  9. Pat’s got the Quibble Alarm ringing off the hook. You see, academic scientists are expected to be truthful and to progress understanding of the natural world rather than to wordsmith the wares they peddle on Yahoo! lists. He’s pathetic, Pat, and so are you. Some people who sell snakeoil are liars and some are just simply idiots. I wonder which applies in this case? Hmmmm…

    — Quibble Alert    2008-11-23 09:07    #

  10. Pat,
    I’m wondering if you have a correct understanding of the GRAS concept.

    Generally recognized – that implies that a group of experts has generally recognized the substance as safe. This implies that the substance has a track record. In the case of OSR, it is a completely new compound. It doesn’t have any track record, because it did not exist before Prof. Haley’s colleague – yes it wasn’t Haley himself – synthesized it for the first time. This is not the same as aspartame, which is an amino acid, and exists in nature. OSR does not exist in nature. It’s not a supplement.

    Let’s take another example of a compound which there is a big track record. There are lots of tests, showing that it is non-toxic, and safe for humans. It’s been shown to be non-carcinogenic, non-mutagenic, not dangerous in pregnancy.

    The compound’s name is
    4,4’-dihydroxydiphenyldimethylmethane

    So, should I be able to market this as an OTC dietary supplement?

    It sounds pretty similar to the compound Prof. Haley calls OSR:

    N,N’-bis (2-mercaptoethyl)isophthalamide

    What if I told you that the common name was Bisphenol A? Would you still say that is was a supplement?

    — Jennifer    2008-11-23 20:23    #

  11. “After analysis they both advised us that there was absolutely no reason why it could not be marketed as nutritional supplement as long as we proved it’s safety and submitted that info to the FDA.”

    Apparently the FDA thought differently in their June 17th response. Did you read it Pat?

    — The Pat Pat show sucks    2008-11-23 20:49    #

  12. Please Ms. K use your investigative powers to answer to the best of your ability the following questions. Perhaps then you will understand the big picture. How did the FDA test the safety of thimerosal in vaccinces? What injectable dose of thimerosal was/is considered safe by the EPA for a newborn infant? an elderly person? How did the FDA/CDC keep track of the amount of thimerosal in the increasing number of vaccines children were given over the last 10 years? Are there individual differences in a persons ability to excrete mercury? Where does meercury go once it is injected into your body? Why did the CDC decide to remove thimerosal from vaccines? (except flu vaccine) If lets say, you want to introduce a new vaccine do you have to test it or do you have special privledges that require no testing (via the Homeland Security Bill?) After you, Ms.Kathleen answer these questions for yourself..then and only then will you get the big picture. Your outrage at lack of testing should be directed toward the vaccine industry…but then again that is just my opinion..maybe it will be yours after you do your own homework.

    — hb    2008-12-24 18:49    #

  13. So, hb, even if your “big picture” were as outrageous as you suggest, would two wrongs ever make a right?

    It’s too bad the holidays have you feeling so cranky. Merry Christmas anyway!

    — Kathleen Seidel    2008-12-25 10:39    #

  14. 14.Why don’t you find out if it is so outrageous…if you are so concerned about the welfare of children as you say. Or do you just like keeping the picture small..like the incidence of Autism according to you. hb,not cranky,just informed

    — hb    2008-12-28 20:45    #

  15. If what hb says about the FDA & vaccines is true, it would seem that there are far more children in danger (in addition to many others deserving renumeration) than from Haley’s gambit.

    I do find it curious that you continuously target certain areas of controversy to the exclusion of others.

    As both a watcher from the sidelines, as well as a parent with a personal stake in the outcome, I have to wonder why you haven’t investigated the many accusations against the vaccine industry?

    I agree & disagree with things from both sides of these arguments, but I am completely baffled at how you and the commenters at your site speak of the FDA as if it wore a white hat & dispensed silver bullets given its fairly discomforting track record.

    Regardless of how one feels about RU-486, just look at it as one blatant example of how political pressure over-rode all the normal procedures for putting people’s safety first.

    IOW, it’s do-able, it has happened many times before, it will happen again unless something is changed – so why are we supposed to believe that it didn’t happen & to have faith that our vaccines really are as safe as we are being encouraged to believe by people who have vested interests in maintaining that blind trust?

    Such an investigation would also do a lot to show that your concern for those who may or may not have been affected is sincere rather than the result of some kind of personal animus as it frequently comes across in your skewering.

    [And if your investigation comes out the way you are already clearly confident that it will, then it gives you an even greater opportunity to show up David Kirby & Dan Olmsted! How could you possibly resist? ;-)]

    — crucifer    2009-01-17 01:19    #

  16. crucifer said “If what hb says about the FDA & vaccines is true,”

    What I could see is that hb did not say anything about the FDA except a bunch of accusations, without proof.

    Then continue “I do find it curious that you continuously target certain areas of controversy to the exclusion of others.”

    It is her blog and she can research whatever she wants. If you do not like it, do not read it.

    — Chris Haynes    2009-01-20 18:21    #

  17. OSR works! It works well. I am so much better. So are my ASD child and my ASD husband.

    — Julie    2009-03-21 22:26    #

  18. Julie, the plural of anecdote is not data.

    — Chris    2009-04-14 16:40    #