Pumping autistic children full of an industrial chelator (revisited)

Remember Boyd Haley?

He’s the Professor and former Chairman of the Department of Chemistry at the University of Kentucky whose formerly respectable career tanked because he fell into pseudoscience. For whatever reason, a while back he became enamored first of dental amalgam quackery to the point where he became involved in organizations like Consumers for Dental Choice (a.k.a. “Toxic Teeth“), whose expressed raison d’etre is to “work to abolish mercury dental fillings”). From that position, he promoted the idea that mercury-containing dental amalgams are horrifically toxic, helping to spread the idea that amalgams cause all sorts of chronic diseases and that the way to treat these diseases is to remove these mercury-containing amalgams. Never mind that there is a very long history of safety and no good evidence that amalgams cause the various chronic health problems attributed to the. To Boyd Haley, amalgams are pure evil in your mouth.

From there, it wasn’t much of a stretch at all for Haley to move on to the equally dubious contention that mercury in the thimerosal preservative that used to be in many childhood vaccines is the cause of the “autism epidemic.” It wasn’t too surprising that he would ultimately degenerate to the point where he became, as Peter Bowditch put it, the “darling of both the anti-vaccination liars and the anti-amalgam loons.” If you want an idea of just how far down the rabbit hole Haley has gone since his days as a legitimate scientists, consider that last month he spoke at the recent pathetic anti-vaccine rally in Grant Park in Chicago at which a truly awful band known as The Refusers played (and Andrew Wakefield sang along). It’s pretty hard for scientists to fall much farther than that, unless they end up running a stem cell clinic in Costa Rica or, even worse, writing original material for Mike Adams or Whale.to.

Oh, wait. He might as well be.

When last we left Boyd Haley, he had just been written up by Chicago Tribune reporter Trine Tsouderos in a story revealing how he had been selling an industrial chelator as a “supplement” to parents who had been pumping their autistic children full of it as part of “autism biomed” treatments to “recover” their children. At the time, I marveled at the sheer chutzpah of Haley’s action. There he was, openly selling an industrial chelator as a supplement without any sort of adequate testing and a “wink, wink, nudge, nudge” insinuation that it would chelate that nasty mercury (from vaccines, of course!) away. Now, Haley’s finally getting into the trouble he so richly deserves, as Trine Tsouderos reports in her followup to her original article, FDA warns maker of product used as alternative autism treatment: OSR#1 is not a dietary supplement but a toxic, unapproved drug with serious potential side effects, FDA warns:

A product promoted to parents of children with autism is not a harmless dietary supplement, as claimed, but a toxic unapproved drug that lacks adequate warnings about potential side effects, including hair loss and abnormalities of the pancreas, the U.S. Food and Drug Administration has warned in a letter to its maker.

The FDA’s June 17 letter to Boyd Haley, a retired Kentucky chemist and hero to the autism recovery movement, details five violations of the Federal Food, Drug and Cosmetic Act related to his product, OSR#1. Failing to correct such violations can result in fines, seizure of products and even criminal prosecution.

Haley has 15 business days from receipt of the letter to respond. Personally, because it contains an excellent description of everything that is wrong with what Haley’s doing, I think it’s worth quoting the warning letter to Boyd Haley from the FDA in its entirety:

June 17, 2010

VIA UNITED PARCEL SERVICE

WARNING LETTER CIN-10-107927-14

Boyd E. Haley, President
CTI Science, Inc.
2430 Palumbo Drive, Suite 140
Lexington, Kentucky 40509

Dear Mr. Haley:

This letter concerns your firm’s marketing of the product OSR#1 on your website, www.ctiscience.com.This product is marketed in violation of provisions of the Federal Food, Drug, and Cosmetic Act (the Act) as described below.

Your firm markets OSR#l as a dietary supplement; however, this product does not meet the definition of a dietary supplement in section 201(ff) of the Act, 21 U.S.C. § 321(ff). To be a dietary supplement, a product must, among other things, “bear[ ] or contain[ ] one or more … dietary ingredients” as defined in section 201(ff)(1) of the Act, 21 U.S.C.§ 321(ff)(1). Section 201 (ff)(1) of the Act defines “dietary ingredient” as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories. The only substance listed as a dietary ingredient on the labeling of OSR#1 is N1,N3-bis(2-mercaptoethyl)isophthalamide. N1,N3-bis(2mercaptoethyl) isophthalamide is not a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Further, N1,N3-bis(2-mercaptoethyl)isophthalamide is not a concentrate, metabolite, constituent, extract or combination of any such dietary ingredient. Thus, because OSR#1 does not bear or contain a dietary ingredient as defined in section 201(ff)(1) of the Act, this product does not qualify as a dietary supplement under section 201(ff) of the Act.

Your website includes claims such as the following:

  • “OSR#1® … helps maintain a healthy glutathione level.”
  • “Both OSR#1® and glutathione scavenge free radicals, allowing the body to maintain its own natural detoxifying capacity.”

The claims listed above make clear that OSR#1 is intended to affect the structure or any function of the body of man or other animals. Accordingly, OSR#l is a drug under section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1). Disclaimers on your website, such as “OSR#l® is not a drug and no claim is made by CTI Science that OSR#1® can diagnose, treat or cure any illness or disease,” do not alter the fact that the above claims cause your product to be a drug.

Moreover, this product is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of OSR#1 without an approved application violates these provisions of the Act.

Your website includes the following statements: “Thyroid conditions, hypertension, and diabetes: Because thyroid conditions, hypertension, and diabetes have been associated with low glutathione levels …” and “OSR#1® … helps maintain a healthy glutathione level.” These statements suggest that OSR#1 is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Because thyroid conditions, hypertension, and diabetes are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use it safely for its intended uses. Thus, OSR#1’s labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). OSR#1 is not exempt under 21 C.F.R. §§ 201.100(c)(2) and 201.115 from the requirement that its labeling bear adequate directions for use because OSR#1 lacks an approved application.

Additionally, under section 502(a) of the Act, 21 U.S.C. § 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the Act, 21 U.S.C. § 321(n), provides that, “in determining whether a drug’s labeling or advertising is misleading, there shall be taken into account (among other things) not only representations made or suggested … but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations ….” Your website states that” [s]ome reports of temporary diarrhea, constipation, minor headaches have been reported but these are rare and the actual causes are unknown,” as well as “OSR#1 is without detectable toxicity” and “OSR#1® … has not exhibited any detectable toxic effects even at exceptionally high exposure levels.” However, animal studies that you conducted found various side effects to be associated with OSR#1 use, including, but not limited to, soiling of the anogenital area, alopecia on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas, and lymphoid hyperplasia. Based on these animal studies and side effects known to be associated with chelating products that have a similar mechanism of action to OSR#1, we believe the use of your product has the potential to cause side effects, and the before-mentioned website statements falsely assert that the product does not have the potential to cause side effects. Therefore, these statements render your product’s labeling false or misleading. As such, OSR#1 is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a).

Because the labeling does not warn consumers of the above-mentioned potential for side effects, the product OSR#1 is also misbranded under section 502(f)(2) of the Act, 21 U.S.C. § 352(f)(2), in that the labeling lacks adequate warnings for the protection of users. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act, 21 U.S.C. §§ 331(a).

The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. In this regard, please note that products are misbranded under section 502(j) of the Act, 21 U.S.C. § 352(j) if they are dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the products’ labeling.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action, without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Furthermore, please advise this office what actions you will take to address product that you have already distributed. Additionally, if another firm manufactures the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Address your reply to the Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237, Attention: Stephen J. Rabe, Compliance Officer.

A description of the new drug approval process can be found on FDA’s internet website at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.
Sincerely,
/s/

Teresa C. Thompson
Cincinnati District

I could never understand how people like Boyd Haley can get away with making claims that this chelator is perfectly safe. I always suspected that it coulsd have potentially serious side effects. After all, any chemical that is as powerful a chelator as OSR#1 is is virtually bound to have at least the potential for serious side effects. Even worse, apparently Haley completely downplayed results that he knew about indicating that the drug could cause in experimental animals soiling (nothing like a little anal seepage to brighten up your day), alopecia (hair loss), and lymphoid hyperplasia. No doubt Haley will represent lymphoid hyperplasia as “evidence” that OSR#1 is revving up the immune system, but in reality one always has to worry about whether such hyperplasia is potentially premalignant if it becomes chronic. Of course, every chemical is basically “toxicity-free” if you don’t bother–oh, you know–to actually look for toxicity or if you minimize any evidence of toxicity that you find in your preclinical testing. Perhaps that’s how on its website CTI can actually describe OSR#1 as “a toxicity free, lipid soluble antioxidant dietary supplement that helps maintain a healthy glutathione level.”

Of note, the usual suspects over at Generation Rescue and Age of Autism have been promoting OSR#1 relentlessly for over a year now. For example, a year and a half ago, AoA was hawking something called the CTI Science Foundation with the purpose of allowing families to experience the wonders of OSR#1 regardless of their ability to pay for the chelator. It would be a wonderful thing if they were paying for science-based treatments or for support for the parents of autistic children, but that’s not what the CTI Science Foundation is about. It’s about providing OSR#1. Given that Founding members included AoA regulars such as Katie Wright, Julie Obradovic, and Jenny McCarthy’s “co-author” Dr. Jerry Kartzinel, it’s not at all surprising that AoA has been promoting OSR#1 for quite a while now, with posts by some of their luminaries such as Kim Stagliano, who wrote a post entitled Unlock Your Health with OSR, The Powerful Antioxidant From CTI Science. Most hilariously, last fall AoA published a post entitled CTI Science’s OSR1 Boosts ORAC Score Better than Acai and other Touted Foods.

Let me just be very clear: Orac has nothing to do with unproven, dubious supplements like OSR1 and would never give such an unproven chemical to children, autistic or neurotpyical. Orac has morals and follows research ethics, unsuccessful attempts to slime him as otherwise by the certain reality-challenged youth contingent of the vaccine-autism contingent notwithstanding. Before a chemical like OSR#1 can be given to children, a lot more preclinical evidence for both safety and efficacy is required. It’s not there for OSR#1.

There, now that that’s clear, let’s move on.

Of course, while I’m now apparently Satan Incarnate among the AoA commenter crowd, the irony is not lost on me how this very same crowd can contort language into pretzels of pseudoscience and logical fallacies so compact that they threaten to form black holes of stupid that suck every last bit of intelligence and science out of our solar system. This same crowd would go on to do the same to the universe if given the opportunity. Don’t believe me? Just read the comments after AoA’s response to Tsouderos’ article. Unfortunately, this time around, most of the responses boil down to, in essence, “now 50,000 people will know about OSR1!” and “Trine Tsouderos is a poopy head.” Meanwhile, real scientists, as opposed to scientists who have lost their way and descended into what is, in my opinion, promoting quackery, are appalled, as Tsouderos reports:

“It would be hard to imagine anything worse,” said Ellen Silbergeld, an expert in environmental health who is studying mercury and autism at Johns Hopkins University’s Bloomberg School of Public Health. “An industrial chemical known to be toxic — his own incomplete testing indicates it is toxic. It has no record of any therapeutic aspect of it, and it is being marketed for use in children.”

And:

“Anything might be a cure for anything else, but the odds are it will do nothing and it might very well be toxic,” said Richard Mailman, a neuropharmacologist at Penn State University. “That is why drug discovery and development is so expensive.”

Careful and rigorous scientists and physicians involved in drug development do adequate testing of their candidate compounds that they propose to use as a drug. This testing is rigorous, long, and expensive. Even then, there are sometimes adverse reactions that are not detected until the drug is approved and taken by much larger numbers of people than are possible to test pre-release. Imagine the sorts of harm that could occur if drugs like OSR#1–and make no mistake, OSR#1 is a drug–were released “in the wild,” so to speak, with only minimal pre-clinical testing and so little human testing that it’s the functional equivalent of none at all.

Another aspect of this whole incident is that it highlights the problems with the DSHEA of 1994, which in essence exempts dietary supplements from regulation as long as they don’t make claims that are too specific. The DSHEA is the very reason that Haley tortured logic, science, and reason to try to represent an industrial chemical as a “natural dietary supplement,” aided and abetted by the anti-vaccine movement. I would argue that the DSHEA is the reason that Haley got away with it for so long. The FDA’s hands were tied until it could nail Haley for making claims to treat specific diseases and misrepresenting the drug’s safety profile. While it’s true that a warning letter doesn’t represent proof that Haley did all this, the listing of evidence in the letter his highly compelling. I can’t wait to see Haley try to respond.

Finally, the case of Boyd Haley demonstrates about as well as is possible the utter hypocrisy of the anti-vaccine movement. They lambaste and castigate any of their perceived enemies for “conflicts of interest” and unethical behavior, whether there is a COI or unethical behavior being completely irrelevant to the character assassination that is the purpose of these charges; yet when one of their own engages in appallingly unethical and, according to the FDA, illegal behavior, they circle the wagons and attack the messenger. The same thing happened with Andrew Wakefield and Mark and David Geier. You just have to remember that this isn’t about ethics. It’s about war. The anti-vaccine movement views itself as being at war–at war with the pharmaceutical companies, at war with the government, at war with physicians, at war with scientists. They’re only partially correct. They are at war with science and medicine. Unfortunately, they’re also on the wrong side of that war.

Other commentary:

  1. FDA To Haley: OSR#1 A Misbranded, Mislabeled, Unsafe Drug by the ever-intrepid Kathleen Seidel. Also included is a linkfest to all her previous extensive detailed work on the topic.
  2. FDA Issues warning letter on “OSR”
  3. FDA warns maker of OSR #1, dietary supplement for autistic children is a “toxic” “drug”
  4. Supporters of OSR #1, “drug” given to autistic children, see FDA warning as no big deal
  5. FDA Steps Up to the Plate on OSR#1
  6. AoA: Come On, He’s A Nice Guy! The FDA is Mean and So Are You!
  7. FDA says diet supplements must be edible