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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

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

172 replies on “Pumping autistic children full of an industrial chelator (revisited)”

You miserable cad, the Tribune comments clearly state that “My vaccine injured son has taken OSR and the improvements have been astounding…. He says ‘OSR makes my body quiet and I feel great.'”

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.

This is an innacurate statement about DSHEA. According to the FDA’s letter, the marketing of OSR#1 violated the New Dietary Ingredient regulations of DSHEA. Any product containing a new dietary ingredient must be pre-approved by the FDA before being marketed as a dietary supplement. Boyd Haley did file a NDI application with the FDA. The agency rejected Haley’s application because:

1) ORS#1 does not meet FDA’s definition of a dietary ingredient
2) Haley did not provide the FDA with sufficient evidence that OSR#1 is safe.

Haley also violated certain provisions of Federal drug laws, so the FDA could have taken action at any time regardless of DSHEA. The fact remains that under the NDI regs of DSHEA OSR#1 was always an illegal product.

Given how long this product has been on the market, the real problem continues to be FDA’s lax enforcement of existing laws.

Otto, Do you know what the plural of anecdote is?
Hint, it isn’t data.

I don’t think Otto was being serious….though it can be hard to sort out the tone of some of these posts (of course, others are fairly simple).

One particular poster here has gone on and on about logic is his/her arguments. In this particular case, how logical is it to give a child an industrial chemical that has received no actually scientific testing for its “stated” purpose & on the other hand, has been shown to be extremely toxic and has serious, proven side-effects?

But, I’m sure no one on the anti-vaccination side is working with “profit” in mind, of course they are all atruistic martyrs, right? These people are the horrible.

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

Perhaps. a straw man, but…

A noted chemist whose office is in a warehouse district???

Maybe, the rent is cheap.

Some of the kids having their health destroyed by this chemical must be teenagers, able to think for themselves. I forsee a damm great class action in somebody’s future…..

“You Cad” ?
Otto, you gotta be joking, right ?
or is it 1880, all of a sudden ?
What next, going to call Orac a bounder?
A Rotter ? A gul -durn carpetbagger?

And… I wouldn’t sell sugar pills to kids, let alone industrial grade chelator.

The plural of anecdote is data, but anyway Otto is making a funny – note the “miserable cad”.

I’m curious to know how much money Haley has made from OSR since he began selling the stuff two years ago, and whether that money could be seized as ill-gotten gains from illegal drug sales. You know, just like they do to other gangsters.

The plural of anecdote is datum, a singular event, data of extremely limited statistical power (that is if the anecdote it actually done and reported accurately). When one applies the information provided by anecdotes to a problem using Bayesian statistics, they provide a tiny nudge in the direction of the anecdote. The nudge is positive but small and of indeterminate magnitude.

It is unfortunate that many people take an anecdote as having negative value; that an idea that is plausible with no data, just from first principles becomes less plausible if in addition to the theoretical plausibility there are anecdotes supporting it. This attitude is completely non-scientific and is just as bad as using anecdotes to “prove” something is correct. Anecdotes don’t have the statistical power or rigor to “prove” anything positive or negative. They are ok for hypothesis generation, for generating questions that can be answered with more rigorous work.

Thanks for sharing this, Orac. After I heard about this in a few different places, I decided to subscribe to FDA’s mailing list, including warning letters. I had a surprisingly extended back-and-forth about OSR#1 with some of the AoA regulars on a thread over there, but never received any decent answers. Not even Kim Stagliano bothered much to answer, other than to warn that the comments were off-topic (which, admittedly, they were and acknowledged in a post that never appeared).

@Jeff

As to FDA taking such a long time, I agree that they need to step up enforcement, though I also understand the extreme magnitude of their job; they have an incredibly large number of products to keep tabs on, all while being one of the least-funded agencies in the government. They need to receive more money to expand their workforce, preferably money from Congress, rather than filing fees paid by industry.

So let me get this straight. They don’t want to give their children tested, proven vaccines but they’ll give them untested, unproven, potentially dangerous industrial chemicals. Makes perfect sense to me.

Yes, my children are vaccinated. No, I don’t think it caused either one of them to be autistic (we have a very strong family. As in, ridiculous. As in people would want to study us). And, even if vaccines did indeed cause autism? I’d rather have an autistic child than a child dead from a preventable disease. Why people think that autism is some gosh-awful, feared disease is beyond me. And I’ve got one of the severe ones. See me whining and complaining? No. I’m just a parent trying to do the best with what I have to raise my kids.

Some form of brain compartmentalization has to be taking place with this. In one mental pocket, you rail and rail against toxins. In another you feed toxic chelators to your kid. In another you blame vaccines without proof for all manner of illnesses. In another you revere a man who lied, falsified research, had massive COIs, and developed a vaccine. If this keeps up, their heads are going to explode.

@Todd W,
Yeah, dissonance is right but not as much fun as hammering the points yet again.

Orac refers to Boyd Haley’s “formerly respectable career (which) tanked because he fell into pseudoscience”.

I was curious – does this refer to Haley’s reputation among his peers, or to actual career consequences resulting from his embrace of woo?

Apparently he still has a (?tenured) faculty position at the University of Kentucky with research interests beyond the chelating of children with autism. Have his autism/dental amalgam-related activities had any tangible detrimental effects on his career?

OSR#1 is obviously dangerous and stupid to give to kids. But even if everything about it was kosher, why would you need to give it to a kid more than once or twice. Once he has had the heavy metals chelated, there is no real reason to do it again. Unless you believe that your child is constantly being exposed to mercury and has inadequate mercury excretion ability on his own.

I have actually seen posts on AoA where parents imply both of these things. There is simply no truth which can get in the way of their reality distortion fields.
They take a dangerous supplement to help fix an injury that never happened and keep taking it to help remove mercury that isn’t there because the child has a deficiency that doesn’t exist.

@ Kathleen Seidel
“I’m curious to know how much money Haley has made from OSR since he began selling the stuff two years ago, and whether that money could be seized as ill-gotten gains from illegal drug sales. You know, just like they do to other gangsters.”

Given your experience with the legal system, I’m surprised at your continuing faith in it.

A few comparisons:

The possibility of cadmium exposure at levels lower than that considered unsafe, due to possible ingestion by drinking, the source of such cadmium being in paint on outside of the glasses, results in the Consumer Products Safety Commission issuing a voluntary recall notice a couple of weeks after the promotional item is released, see http://www.cpsc.gov/onsafety/2010/06/shrek-glasses-recalled-due-to-cadmium-risk/ which recall McDonald’s carries out at the cost of several $Millions. see, McDonald’s Recalls ‘Shrek’ Glasses (June 4, 2010) http://online.wsj.com/article/SB10001424052748704764404575285812243788750.html .

As to OSR#1, it takes the FDA some 2 years to issue a warning letter. No recall, injunction or other action by any government agency appears imminent.

Meanwhile, the Center for Science in the Public Interest is going to sue McDonald’s over toys in its Hapless Meals on the theory that parents can’t say “No” to their children. see, McDonald’s Faces Happy Meals’ Lawsuit (June 23, 2010) http://www.latimes.com/news/health/sns-health-mcdonalds-happy-meal-lawsuits,0,1457303.story

No reports of possible suits related to OSR#1 are reported.

The cynic in me suspects that the legal theory known as “find a deep pocket defendant” is in play.

But, there may be more than one means to defur the feline.

One could note that Prof. Haley’s company touts that OSR#1 has the highest “ORAC” score — higher even than chocolate. I’d think that Orac may be entitled to compensation. After all, the “Naked Cowboy” who hangs out in Times Square says that he’s entitled to a franchise fee from the “Naked Cowgirl”, see NYC Naked Cowboy to Naked Cowgirl: Stop copying me (June 22, 2010) http://www.dailycomet.com/article/20100622/APA/1006220721?Title=NYC-Naked-Cowboy-to-Naked-Cowgirl-Stop-copying-me . To me, if getting naked is now an intellectual property right entitling some guy in Times Square to $500 per month from everyone who indulges in that pasttime (or, who only wants to reserve the right to do sometime), then “Orac” should receive compensation from some one who represents that he’s better than chocolate.

I mean, how many things are better than chocolate? That’s quite a claim while using his name. And, such a claim is valuable.

In early 2009, someone,whose name momentarily escapes me,wrote presciently about the coming “bad year” for anti-vaccinationists:it was, and 2010 has proved to be even worse and the damage has extended beyond that narrow, but highly significant area.If I didn’t know better,it would *almost* appear as though there is a *concerted*,sustained effort by a coterie of like-minded opponents of pseudoscience, working tirelessly to overturn dodgy research and over-enthusiastic self-taught “experts”.Each victory is also grist for the conspiracy mills,churning away in near-unison.Fortunately,as the conspiracy grows exponentially to explain more events,its potential audience shrinks proportionately.

Dangerous Bacon,
If you click on Haley’s link to “our group’s publications” you’ll see the list ends in the late 1990’s. I believe Haley is emeritus.

This is madness. It’s incredible to me that people who must be smart and capable (to some degree) can buy into this crap.

What density of anti-vaccine parents will we need before polio becomes endemic among their children?

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.

I just wanted to add, this isn’t about their children either. They simply can’t be thinking about the welfare of their children and give the children such an unsafe chemical.

I am even more protective of my autistic son than my daughters because he can’t always tell me when something is wrong. Were he to have a drug reaction, he wouldn’t understand what was happening to him. It is hard for me to fathom the mentality of parents who are willing to do anything (safe or otherwise) to “cure” their children. They will do anything aside from accepting their child’s condition.

Goddess,

I’d rather have an autistic child than a child dead from a preventable disease. Why people think that autism is some gosh-awful, feared disease is beyond me.

I am with you. To me my son is just my son. I feel like when one decides to become a parent one signs up for bad and good. Whether it be my first son dying of a fatal birth defect, or my second son having autism. I do, however prefer the living autistic son. Go figure.

Dave that is super,

They take a dangerous supplement to help fix an injury that never happened and keep taking it to help remove mercury that isn’t there because the child has a deficiency that doesn’t exist.

Just thought that phrase was awesome enough to be necessitate repetition.

Most heartbreaking of all, infants (who are too young for the vaccine)* are dying of a vaccine preventable disease in California. This is all just a diversion from the real issue. Vaccination is vitally important to public health.

*Que a dickhead troll pointing out that these deaths don’t count since they were Latino babies.

One of the most convincing pieces of research (among many) I have seen that demonstrates the safety of mercury amalgam fillings is this one. Children with amalgam fillings excrete an average of 1.6 µg Hg per gram of creatinine in their urine, children without amalgam fillings an average of 1.4 µg Hg per gram of creatinine. It seems to me this shows that children ingest a significant amount of mercury independent of amalgam fillings (or vaccines for that matter). Mercury is in our food, in the air from burning fossil fuels, and in the soil. I guess that is why some parents have been chelating their children for years, with seemingly no end to the mercury that “comes out of them”.

As for OSR, it is surely far more dangerous than thimerosal in vaccines, in terms of the risk of known or unknown short or long term side effects. Quite how parents who are giving this to their children assess risk is beyond me.

Oh, yes, they are at war. I wish they only tried to talk this issue to death, but they’re taking action. As more and more of them stop immunizing, the whole damn thing is in peril. By “whole damn thing”, I mean THE WHOLE DAMN THING. Earth. Humanity.Reason.

Again, I am reminded of the Ninja Turtles:
Leonardo – “Shredder, you gotta listen to reason, you’re going to destroy us all!”
Shredder – “Then so be it!”

Shredder then proceeds to bring down the dock and the buildings above it, killing himself.

Kristen @21:

I think those parents are focusing on a very narrow idea of what their children “should” be, rather than on who their children actually are. It’s the same distorted thinking that leads parents to beat gay children and then throw them out on the street. Sure, they might wish that their kids were neurotypical and heterosexual–but that should be on the same level of “it would be nice” as wishing that the kid was valedictorian, or star of the football team, or had perfect pitch and could sing professionally. None of those are things parents should demand, or torture their children to try to make them live up to.

I’m not saying it’s easy. Parenting is important work, and sometimes difficult. From what you’ve posted here, you’re doing that work, and doing it well. Not everyone can let go of expectations, can see that even if they would have liked a star quarterback or someone to take over the family electronics business, the child they have is there, is who s/he is, and someone they can and do love.

This is completely off-topic, but a friend just sent me this link to a blog about a girl who is chronicling her cancer treatment here in my home city of Vancouver. Those of us who are interested in cancer patient experiences (and maybe why some people resort to woo) should take a look at this – it’s moving stuff.

Oh, and autism and vaccines, chelators, amalgam. Yeah! (Thread-jackery narrowly avoided through extreme smokescreen-y cleverness!)

MikeMa wrote:

Some form of brain compartmentalization has to be taking place with this. In one mental pocket, you rail and rail against toxins. In another you feed toxic chelators to your kid.

One of the characteristic traits of the scientific method is that it should not matter who comes up with the theory, who does the experiment, or why they do it. It doesn’t matter what the scientist’s attitude is, or whether they are sinful, or in a state of grace — not if they are honest when it comes to following procedures.

Science specifically evolved to assume, and then eliminate bias. It trusts no one. The focus is on the objective process, not the subjective person. If you do the same thing, you will get the same results. Nature doesn’t “care” about people, so that results differ depending on who is “worthy” or not.

Unscientific thinking tends to reject this. People matter more than method, and intention provides the clue to where you should put your trust. If a pharmaceutical company feeds toxins to kids, their intent is bad, and so it will cause harm. If a Brave Maverick Doctor feeds toxins to kids, his intent is good, so there will be no harm. It’s like reading a story. The good guys don’t need the careful scrutiny, the checks and balances, you put on the bad guys.

They’re consistent in trusting the good guys, and not trusting the bad guys. They think science – and nature — do the same.

yeah, and while you’re at it you should be onto that,like, chemo thing. As someone else mentioned, I heard it can cause hair loss and burns. Oh yeah, and it’s like so fitting that, like, the FDA (which is a totally cool and upstanding regulatory body) would be coming down on OSR. OMG! and wow, what a surprise that Johns Hopkins and the NIMH (Dr’s Silbergeld and Halsey, no strangers to the vaccine world) have pulled the plug on the mercury chelation study. That Tribune sure is on the ball! See:

http://www.alexa.com./siteinfo/chicagotribune.com#

Orac, you and your partnership with [university redacted] Sanofi-Aventis/Pasteur (second largest vaccine manufacturer) is, like, totally a surprise too. I doubt you will print this. I double dare you to.

Looking at google scholar, the only stuff Haley published after 1999 is mercury related, in such prime journals as Medical Veritas and International Journal of Toxicology. How he staid department head until 2005 without doing any research I don’t know, he officially retired in 2008. But his academic career was over at age 60, very early for a tenured faculty. So DB, I think Orac is correct to classify it as “tanked”.

@ Sastra 26

“They’re consistent in trusting the good guys, and not trusting the bad guys.”

Very good analysis.
I should remember this. I tend too easily to write off anti-vaxers as stupid, where it’s more about who they trust.

And as in the best stories, some of the perceived good guys are not that good, and even if their goals are noble, they will cause harm.
If all bad guys in the real world could call themselves something like Wormtongue or Dark Helmet, life would be easier.
Sadly, there is no good guys and bad guys, only bad guys. Simply, there are not all working on the same side.
Figuring out which side is the good one is the tricky part.

Further to #28, there’s been an excellent 5-part NY Times series on the Dunning-Kruger effect. The effect is that folks who know little don’t realize just how ignorant they are, so they self-assess as smart, while those who know a great deal are painfully aware of how much they have yet to learn, so self-assess much more critically.

Along with ignorance and the resulting inflated self-assessment come (1) a corresponding lack of respect for “experts,” since the ignorant believe they know all the important stuff and a contrary conclusion is therefore just a contrary opinion; and (2) an inability to critically assess the competence of others, so there is no way to spot a scam artist’s lack of relevant knowledge.

Thus folks who don’t have the background (and who may therefore be concerned about being taken advantage of) are ironically fertile soil for others pushing conspiracy theories all about what “They don’t want you to know.”

Sounds distressingly familiar in the context of “I’m selling you the cure-all Big Pharma doesn’t want you to have!”, doesn’t it?

Lessons:

“Natural” OSR with known harmful side effects= Good
Natural squalene with no known side effects= Bad

Disgraced researcher struck off for ethics violations= Good
Respected researcher with a vaccine patent= Bad

Advertising dollars from poorly-regulated compounding pharmacies= Good
Grants from successful “Big Pharma” co= Bad

Poor illegal immigrants killed by preventable disease= good
Rich white people diagnosed with autism= bad

We should start a class action against Haley. Can someone list the names of what must be thousands of people who have had a serious reaction to OSR. While we’re at it, let’s get Wakefield to. Can someone post the thousands of names of parents who have issued complaints against him. What! We can’t find a single person for either? Luckily, we have thimerosal (ethylmercuric chloride) as an antidote for OSR! Let’s do some science also. Orac, you take 100 mg of thimerosal and I’ll take 100 mg of OSR (like I have everday for the last 1.5 years).

“I tend too easily to write off anti-vaxers as stupid, where it’s more about who they trust.”

I think this is an important point. As someone who used to be anti-vacc, I think that this is a large part of it. I remember when the lightbulb went on for me and I realized that it’s about the data itself not the person presenting it.

Cattleprod were you this stupid before the OSR treatment or is it a new development?

Cattleprod writes:

I’ll take 100 mg of OSR (like I have every day for the last 1.5 years).

And you take that much OSR because…you gargle thermometers for a living?

Orac, you and your partnership with Sanofi-Aventis/Pasteur (second largest vaccine manufacturer) is, like, totally a surprise too. I doubt you will print this. I double dare you to.

Jen’s record remains unbroken.

@Cattleprod

One other thing. Whether thimerosal has adequate clinical trials or not says absolutely nothing about OSR#1. If you make a claim that “thimerosal was not properly tested, therefore OSR#1 is fine (or doesn’t need testing)”, you’re engaging in logical fallacy. The evidence for OSR#1 should stand or fall on its own merits.

@D. C. Sessions

Apparently, prolonged exposure to AoA’s Flavor Aid turns one into a valley girl. As evidence, I present the “like, totally new and stuff” jen.

“oh I am so smart, OSR is so toxic”…haha this is laughable compared to “pumping children full of one of the biggest neurotoxins on the planet known as mercury”. Get a clue you morons!!!

Has jen been drinking? What a weird post.

Does she seriously not understand that knowing that a drug can be harmful and understanding the risks and side effects is different than having no idea what the side effects are, or having any information about how dangerous it is? Also, chemotherapy is used for something that could kill you, so most people are willing to accept some risk.

And does anyone know what that Sanofi-Aventis/Pasteur reference is all about?

Poogles :”As someone who used to be anti-vacc, I think that this is a large part of it. I remember when the lightbulb went on for me and I realized that it’s about the data itself not the person presenting it.”

Same here. Except, I used to be “pro-vax”. I too remember looking at the data and realizing something isn’t right here. Somebody’s not being entirely truthful. Turns out a lot of propaganda is used when selling mass vaccination.

“Science is built up of facts, as a house is with stones. But a collection of facts is no more a science than a heap of stones is a house.” -Henri Poincare

And does anyone know what that Sanofi-Aventis/Pasteur reference is all about?

The university where Orac’s Super-Sekrit Identity works has received some funding from S-A/P, although not for his lab or department. Thus, by the Transitive Property of Pharma Shill Contamination, Orac is a complete slave to all of the members of Big Pharma, unable to think a single thought or type a single word without their approval.

Smarter Than You, you have been around here long enough to get a clue yourself. You should know by now that the mercury discussed in reference to vaccines is ethylmercury, it is not bioaccumulative, and that the toxicity is different than other forms of mercury. The distinction is important. Also, the doses are very small. And dose does matter.

Somehow I missed jen’s wonderful comments. Sadly, I predict this is only the first of many idiot anti-vax people posting stupid comments about “Sanofi-Aventis/Pasteur” and Orac’s funding. This is because they’ll take at face value the comments of a deceitful Jake Crosby and completely ignore what Orac himself said about it.

Which is hard to believe, because its not like anti-vaxxers have a track record of ignoring the truth because they’d rather believe some random jerk on the internet.

Oh goody, STY is back. How’s the groundbreaking revolutionary publication going? Clearly, working on it hasn’t made you any more coherent or logical. Ah well, I guess them’s the breaks.

@Travis – Jake Crosby posted an “exposé” of Orac’s “friend’s” ties to S-A over at AoA. Apparently because he works at a university that, like all universities, gets partial research funding from a pharmaceutical company, he is therefore inextricably linked to Big Pharma. Doesn’t matter that his research has nothing to do with autism or vaccines, and that he doesn’t get any money from the pharmaceutical companies, and has no reasonable expectation to receive any in the future… none of that is important. Jen has decided to live up to her usual level of cognitive function and quote an article that has been thoroughly debunked both here and on several other blogs.

Chelation therapy for autism has killed several people, including some young children.

google search:

Kids Chelat™ Chelator
http://www.evenbetternow.com Use Kids Chelat™ to chelate heavy metals from your child. Proven safe Google Checkout

Search ResultsBoy with autism dies after chelation therapy – Autism: The Hidden …
Aug 25, 2005 … Boy with autism dies after chelation therapy. 5-year-old was receiving controversial treatment in doctor’s office …

FWIW, when I typed a quick search into google, the google ads gave me a number of links to buy chelators for my autistic children. Looks like the FDA is bailing out an ocean with a tea spoon.

@Travis

jen is regurgitating a bunch of nonsense over at Age of Autism. I have a post on it (well, mostly on the comments) over at Silenced by Age of Autism. You see, jen reads something over at Age of Autism and, rather than think critically about it, swallows it whole and then spews it out over here, as if what she says had any actual scientific merit.

Hmm, interesting. I cannot stomach AoA and Jake any longer so I rarely read what is going on over there. I definitely missed that. Couldn’t a silly, non-link like that just as easily be made to some of the anti-vax heroes? They must be part of the conspiracy as well.

Thanks for all the answers about my question. I should have said that before.

I just reread jen’s comment. I love the little part about her daring Orac to post it. Does she still not notice how little moderation actually goes on here?

@Travis

I just reread jen’s comment. I love the little part about her daring Orac to post it. Does she still not notice how little moderation actually goes on here?

Well, she has been thoroughly steeped in the AoA culture, where censorship moderation is the norm, so it’s not surprising that she would think that the “enemy” would suppress her comment.

But she has been here for a long time, I would have thought their might be some basic pattern recognition available that would allow her to notice that almost everything gets posted eventually.

“The university where Orac’s Super-Sekrit Identity works has received some funding from S-A/P, although not for his lab or department. Thus, by the Transitive Property of Pharma Shill Contamination, Orac is a complete slave to all of the members of Big Pharma, unable to think a single thought or type a single word without their approval.”

Plus the contamination spills over into the comments, meaning everyone here who makes pro-science statements is in thrall to Big Pharmavax.

I love being in thrall. Gives me goose bumps, it does.

I am a grad student and just started working with a company, in a collaborative fashion, that makes instruments that pharmaceutical do use. I guess that means I am now doubly tainted after commenting on here.

Can someone list the names of what must be thousands of people who have had a serious reaction to OSR. While we’re at it, let’s get Wakefield to.

In mailing lists, and in the Omnibus Hearings, you will find parents who report adverse effects from chelation therapy. However, you’ll never see them file lawsuits against the snake-oil peddlers. The reasons for that should be fairly obvious. For one, they’d have to admit making a huge mistake and endangering children themselves.

@Ian and Travis: If you read Science Based Medicine, you will also learn that (gasp!) Orac’s Sooper Sekrit Identity (hereby known as SSI) person is doing research using medicines!. In fact, he’s using a drug that some other person found really cool uses for, and he’s investigating its possible use as an adjunct drug for breast cancer treatment.

BUT, like many other drugs, it has other uses, and is being investigated for use in people who have obsessive-compulsive disorder, including (wait for it…….) children with autism! Even though children with autism are just one small subgroup of the main investigative group, this means that anyone using the drug is in the pockets of Big Pharma.

So therefore, Orac is in the pockets of Big Pharma even though he knew nothing about the drug being investigated for this other use. He also does not get the drug for free. Really, if I was going to be a Pharma Shill, I would at least insist that I get the damn drug for free. Research money is tight and getting the drug for free would help a lot.

(Man, as this thread goes on, I become happier that I killfiled STY a long time ago. May just do that to ‘jen’ too; it’s sad to think my Canadian relatives could have embarrassing neighbors like her.)

What’s interesting is that jen’s post was held up for moderation, and then allowed to go through. It popped into existence between two comments that were sequential earlier in the day. I don’t know if I’m the only person who checks these things obsessively frequently enough to notice that kind of stuff…

MI Dawn, I sadly run into Canadians like her on a fairly regular basis. I wish we had fewer of them but woo is fairly strong here.

In all fairness to jen, I did redact the name of my university. Not that it’s hard to find or anything, but I saw no reason why I should make it so easy that even STY could find it.

It is worthy of note that this warning letter was posted on FDA’s site very quickly. There could be any of several reasons for this, but it is quite likely that FDA wants to shut this operation down right away. The nature of the complaint is such that Boyd Haley will have no choice but to stop shipping OSR#1. Given the risk to public health, the sooner that happens, the better.

I would have thought their might be some basic pattern recognition available that would allow her to notice that almost everything gets posted eventually.

If she were vulnerable to cognitive dissonance, she wouldn’t be the Jen we know, eh?

Jen,

Did you read the letter from the FDA? They said:

– you call it a supplement, but it’s not by any legal definition of the word supplement.
– you say it’s not a drug, but you claim it does things drugs do. Therefore you’re selling it as a drug.
– if you’re going to sell it as a drug, you need to follow the rules that prove safety and effectiveness. You also need to follow the rules about informing people of the possible side effects.
– please stop these clear violations of the rules.

Chemotherapy drugs (as I understand it) went through a process of proving them to be effective and safe (with a particular meaning of the word safe). They do have side effects; some are pretty nasty. Those side effects are spelled out and disclosed to the doctors and the patients.

So I’m unclear on why you think it’s so wrong for the FDA to “come down on OSR” for not following the rules, but you think they should come down on chemotherapy drug manufacturers who did.

First of all the FDA sent this letter via UPS instead of the US Postal Service. Exactly how accountable is this agency?

OK secondly, does OSR#1 remove heavy metals or not?

Last, didnt the FDA come down on Cheerios for making a claim that the cereal was good for your heart?

@65

1 – I’m really not sure how that is relevant. My work uses Purolator as a courier service rather than Canada Post, even though we are technically a government agency. Does that impair the quality of our research findings in any way?

2 – That is a bad question. First of all, it assumes that removing heavy metals from autistic children is useful. The literature is pretty clear that autism is not mercury damage; they don’t even look similar. Secondly, it doesn’t take into account that it may not be safe for use in humans. Rusty nails have lots of iron in them, but I wouldn’t recommend eating them as a treatment for anemia.

3 – I’m not sure what the regulations are in the U.S., but Health Canada has cracked down similarly on consumer product health claims. General Mills is not, for example, allowed to say that eating Cheerios reduces your risk of heart attack. What they are allowed to say is that a diet with lots of fibre lowers your cholesterol, and that Cheerios is a good source of fibre (or something along those lines). There is a rigorous process that products must go through in order to be allowed to make specific health claims, and if they haven’t undergone that process there are legitimate grounds for restricting what you can say about them.

@42:
“Sty” posted pretty much the same comment at LBRB earlier today. Apparently, he’s spamming through blogs rather than giving us the benefit of his conversation.

Another link, this one more on-topic:

One is Enough

This is a woman’s plea to have people vaccinate, since losing her child to pertussis. I kind of want to lock Sid Offit in a room with her, give her a spiked bat, and paint a target on Sid’s scrotum. Luckily, I have no way to make that happen (and in all probability wouldn’t stand for it if I did have the means).

MI Dawn, what’s really sad is how the kids are getting screwed out of any fair look at this issue. I do have to credit Orac for not screening out my post.

@65 – @bensmyson

I think Ian addressed your points 1 and three very well. One additional comment on point 2.

In the letter from the FDA it says:

“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.

Is there any proper (in the FDA meaning of the term) study you’re aware of that was done to prove these claims? If so, I would think the manufacturer would provide them to the FDA and clear this up.

And my question back to you: had some Large Pharmaceutical Company sold the exact same product using the exact same claims and with the exact same level of proof of safety and efficacy, would you defend them as well?

OK secondly, does OSR#1 remove heavy metals or not?

Who knows? That is what research is for. Doesn’t look like much of any has been done for this chemical.

Several children have died from chelator therapy. That “research” was done the hard way.

And lastly, why does it matter whether these chelators remove heavy metals or not? Scientists have looked hard for any connection between autism and heavy metals. It isn’t there, they have nothing to do with autism.
As the kooks always forget, thimerosal was removed from vaccines years ago. Didn’t make a damn bit of difference in the occurrence of autism.

jen,
Kids are getting protected from the unknown dangers presented by an inadequately tested agent. They are being cheated by their parents searching for ways to fix them when they are not broken.

Raven – Several children died? From OSR#1? Really?

It is my understanding that pediatricians chelate children when their heavy metal levels are extremely high, lead, mercury, antimony, uranium, arsenic, etc can be toxic and wreck a child. Does heavy metal cause serious health issues in children? Yes. Is there another way of removing these toxins?

As a shill for big supplement. I make my living selling pills.

I support science. Science is what discovered treatments for berri berri, pellagra, xerophthalmia, scurvy etc. Science is what determined correct levels of calcium for women to consume at a young age to reduce the risk of osteoporosis. It is an awesome process, AND I LOVE IT!! I also respect all the work pharmaceutical researchers do to treat illness. I detest woo, DETEST IT.

Oral chelators make no sense. How do you make sure it doesn’t chelate out all the metal ions known as electrolytes, unless the OSR is designed to bind to only mercury. Which I am not willing todo research on tonight.

And Ethyl mercury is as different from methyl mercury as Proanthocyanidins or cyanocobalamin are from hydrogen cyanide or potassium cyanide.

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