An Inquiry Emerges · Aug 14, 08:00 PM

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

Comments


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

    — Robert Estrada    Aug 15, 02:37 PM    #

  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    Aug 15, 05:47 PM    #

  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    Aug 15, 06:31 PM    #

  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    Aug 18, 09:39 AM    #

  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    Aug 20, 03:32 PM    #

  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    Aug 20, 05:53 PM    #

  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    Nov 19, 12:38 PM    #

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