Pumping autistic children full of an industrial chelator (revisited again)

As much fun as I had at TAM8, there is one consequence of being out of town and not paying attention to the blog or the Internet as much as I usually do. Well, actually, there are multiple consequences. One is a momentary lapse in insanity. In other words, it’s good for the mental health to cut back on the blogging. True, such is the level of my insanity that I didn’t just stop altogether for five or six days, as I probably should have, but what can I say? Another consequence is that inevitably one or more things pop up that under normal conditions I’d be going full mental Orac on that somehow escape a loving application of a heapin’ helpin’ of not-so-Respectful Insolence.

There are exceptions, of course.

One of these exceptions is Boyd Haley, whose vileness I can’t let pass uncommented upon. Truly, in Boyd Haley’s case, it’s better a couple of days late than never, particularly in this case. For those of you who aren’t regular readers and may not remember who Haley is, he’s a former chairman of the department of chemistry at the University of Kentucky who several years ago somehow fell into the woo pit and became convinced, as so many cranks before him, that dental amalgams are the root canal of all evil. Basically, to Haley, dental amalgams leech toxic quantities of mercury into your mouth and poison you slowly over time. It doesn’t matter that there is copious evidence that dental amalgams are safe and no real convincing evidence that they are not other than the dubious claims on anti-amalgam websites. Haley believes. Unfortunately, his chemistry background has made him more convincing, but in my book Haley is proof positive that it is quite possible to become a crank in one’s own field of expertise and then move on.

Where Haley moved on to, not surprisingly, is anti-vaccine crankery, in particular the belief that proliferated towards the end of last century and the beginning of this one that the mercury-containing preservative commonly used in childhood vaccines until the end of 2001 (thimerosal) caused and “autism epidemic.” Never mind that this is a myth that has been thoroughly discredited from a scientific standpoint. Never mind that even the anti-vaccine movement has been backing away from this concept since 2007–well, until recently, I guess, given that Mark Blaxill and Dan Olmsted are writing a book blaming the “autism epidemic” on mercury. The book is so…2004. The conspiracy theory has moved on, and the goalposts have shifted since then, but apparently Boyd Haley hasn’t gotten the message. Doesn’t he know it’s now “Too many too soon” and “Green our vaccines”? To him, everything old is new again.

Unfortunately, as has been reported by Trine Tousderos (as well as the FDA warning letter sent to Haley’s company) and documented extensively by Kathleen Seidel before that, Boyd Haley’s mercury mania, the same nonsense that led him to label autism as “mad child disease,” continues to lead him down the rabbit hole of pseudoscience. Specifically, Haley has marketed a fine white powder consisting of an industrial chelator as a “dietary supplement” to be used to chelate mercury and heavy metals. So blatant was Haley’s attempt to slip his chemical in under the radar as a “dietary supplement” rather than a drug that the FDA has gotten on his case and rightfully so, albeit far later than it should have.

Finally, Haley has responded.

Haley’s response took the form of an op-ed piece published Monday in the Lexington Herald-Leader entitled Dietary supplement safe for right use chemical name might be confusing; toxic effects low. I have no idea why any reputable editor would allow such a disingenuous and misleading, self-righteous cube of concentrated nonsense see print in its editorial pages, but apparently this editor did. In it, Haley repeats the same misinformation that his company has been using to promte the dietary supplement OSR#1 ever since the beginning. But first, he has to start with the ad hominem attack:

This is just one of several Chicago Tribune articles focusing on criticism of doctors who treat autistic children, raising similar concerns to that of a fringe group called Neurodiversity, which thinks autism should be celebrated instead of treated.

How can Haley use logical fallacies? Let me count the ways. Let’s see, there’s the ad hominem attack, referring to his critics as “fringe” and denigrating neurodiversity. Then there’s a bit of tu quoque in referring to his critics as “fringe,” when in fact it is the autism “biomed” movement that lionizes Haley that is truly fringe in that it defends the practice of selling a chemical designed as an industrial chelator as a dietary supplement when OSR#1 is not, nor is it derived from, any natural dietary ingredient. But let’s put it this way. Even if all of Haley’s critics were radical neurodiversity types (whatever that is; I have no idea what such a person would look like), it would be irrelevant to whether their criticisms of Haley are valid from an evidentiary and scientific viewpoint.

Haley then writes something that is demonstrably untrue:

It is critical to be noted that there has been no report of any significant adverse effect for OSR#1. Our legal representation has contacted the Food and Drug Administration and we are working with the agency to resolve its concerns.

While I have no doubt that Haley’s lawyers are working overtime to try to save his tuchas from being hauled into court, it is not true that there have been no reports of significant adverse events. The ever-intrepid Kathleen Seidel has spent considerable time and verbiage documenting just such reports. Of course, what allows Haley to keep up a patina of plausible deniability is the fact that the parents who subject their children to chemicals of unknown toxicity with no evidence that they are safe, much less effective, don’t in general complain to the FDA when such “supplements” cause adverse events. Instead, they go to the Internet and to mailing lists like chelatingkids2. There, Seidel has documented parents reporting all sorts of adverse events that sound suspiciously as though they are related to OSR#1. These include increased thirst, urination, salivation, and mucus production; constipation, diarrhea, and gastrointestinal distress; upper respiratory symptoms; insomnia, emotional lability, agitation, and cognitive and behavioral changes; headaches and fatigue; fever; rashes, hives, and bruising; seizures; yeast infections; increased menses; and lowered platelet counts. Indeed, there have even been some reports of hospitalizations. Just to give you a flavor of the sorts of things Seidel reported, here are a few examples:

There were a couple of kids and a couple of adults that ended up in the ER with very high temps and viral titers through the roof. Adding OSR at full dosing was the only change and none were “sick” with other symptoms, this happened within 24 hours of starting. We do not necessarily know who will react that way, that is why we advise ramping up dosing slowly to avoid viral reactivation. [Dr.] Julie Buckley will go over what we have seen, the good the bad and the ugly at NAA.

Then there are cases suggesting that OSR#1 could be lowering platelet counts:

I started my son on OSR last September… We initially saw charcoal-back stools, which got me worry, as black stools can suggest blood in the stools. I spoke with Dr. Klinghardt about this. He said that OSR could thin the blood. For children with inflamed gut, OSR could cause very mild bleeding initially and some inflamed gut mucus could be flushed out. He said not to worry, but if the black stools remained after a few days, I should stop OSR and collect stool sample to test for blood in stool. After 3 or 4 days, my son’s stools returned back to his normal stool color; I never did test him for blood in the stool. Still I was not at all easy with OSR, so I decided to take OSR myself one month after my son had been on it. There was not much information online about it and still isn’t… I was on OSR for two months. And two months in a row my periods for the first time in my life lasted for about two weeks each time, during which my blood gushed down like waterfall each time when I used the restroom. Because of the earlier conversation with Dr. Klinghardt, I started to suspect that OSR might thin the blood and increase blood flow by virtue of lowering blood platelets… I then tested my son’s blood platelet level, for first time in 3 years of periodically testing, my son’s blood platelets dropped below the reference range… I also exchanged a few emails with a mom who posted at another group that her teenage girls’ periods became irregular after the use of OSR…

Then there was bruising:

My son started getting bruises on OSR with Phospholipid exchange — followed doc’s dosing instructions. I stopped OSR after ~3days cos new bruises kept showing up each day that he was on it. Bruises eventually disappeared and no new bruises showed up after stopping OSR.

These are just a handful of the reports on chelatingkids2 that Kathleen Seidel culled from discussions of OSR#1. Who knows which of these adverse events are caused by OSR#1? That’s not what the adverse event reporting system is designed to do. It’s designed to serve as an early warning system to suggest problems that might be due to a drug. In order to detect possible adverse events, we need to know what sorts of problems occur after taking a drug and then look for patterns to see if these problems are likely to be due to the drug. The problems described in the postings to chelatingkids2 above are exactly the sorts of reactions or events that are reported during clinical trials of potential new drugs, testing that OSR#1 hasn’t gone through, at least nothing resembling the testing all new drugs must undergo before approval. After cell culture and animal testing, all new drugs have to undergo testing known as phase I tests, which involve giving increasing doses to people with the condition for which the drug is designed until signs of toxicity are found. These trials determine the maximum tolerated dose and suggest a dose to use in subsequent clinical trials to test efficacy. As far as I can tell, OSR#1 has never undergone a properly designed phase I trial with proper dose escalation and monitoring for signs of toxicity.

Instead, what we see is in essence completely uncontrolled experimentation using children as experimental subjects with completely inadequate informed consent informing parents of known risks. So many human experimentation ethics appear to be being violated that it’s hard to know where to start. Moreover, if OSR#1 were being properly tested or marketed, these adverse events would be reported to the FDA by physicians and practitioners. Not OSR#1. The only reason there are no reports of adverse events potentially attributable to OSR#1 is because Haley appears not to look for them and OSR#1 users appear not to report them anywhere other than on chelation therapy discussion forums on the Internet. Can you imagine what Haley and his supporters would say if a pharmaceutical sold one of its products that way? Truly, the double standard at play here beggars belief.

Haley also makes this claim:

CTI Science has never made any medical claim regarding OSR#1; no claims to use OSR#1 to treat autistic children have ever been made. Our Web site was previously approved by legal experts to ensure it was not in violation of FDA regulations.

Uh, no. Although I have no doubt that legal experts approved the CTI website, complete with a quack Miranda warning, Trine Touderos documented quite well that health claims were being made, as did the FDA. Still, that’s not what irritated me the most about Haley’s article. Actually, I don’t know if I want to laugh or cry to see a once respected professor of chemistry, the chairman of his department, write something like this. Actual chemists out there (and I know you’re out there) please put your coffee down before you read this next passage. I won’t be responsible for ruined keyboards from your spew:

The letter from the FDA might also have been caused by a naming misconception. The chemical name of OSR#1 is N1N3-bis-(2-mercaptoethyl)isophthalamide, which might imply a complex chemical with no natural components.

However, the structure of OSR#1 contains a benzoate group (found in cranberries) and two cystamines (a metabolite of cysteine and found in all meats).

The FDA description of a dietary supplement extracted from their warning letter is: “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.”

It is apparent that OSR#1 bears and contains one or more dietary ingredients and is why OSR#1 was submitted over two years ago to the FDA for consideration as a dietary supplement. It might be that the chemical name we placed on the label has confused this issue.

Uh, no. Once again.

There’s been no mistake. After all, as is documented in this recent paper in the peer reviewed chemical journal Fuel by Lisa Blue, Partha Jana, and David Atwood of Haley’s very own department of chemistry and by Kathleen Seidel, BDTH2 (the abbreviation for the chemical that became OSR#1) was designed from the beginning to be a chelator.

Perhaps the most unintentionally hilarious part of this excuse is the part where he talks about a benzoate group and cystamine groups. I can’t conclude anything from this passage but that Haley must have utter contempt for his audience. Chemical groups when combined can often result in chemicals with very different chenmical properties than the constituent groups. This is Organic Chemistry 101 here, people, but Haley seems to think his audience is too ignorant to know that you can put different chemical groups together and come up with a product that has very properties.

As the “naturalness” of OSR#1, get a load of how it’s synthesized:

This general procedure can be scaled to prepare smaller or larger amounts of BDTH2. Triethylamine (TEA; 52 mL, 38 g, 375.53 mmol) in chloroform (100 mL) is added slowly to a stirring solution of cysteamine hydrochloride (21.20 g, 186.6 mmol) in chloroform (200 mL) in a 3 L round-bottom flask with a nitrogen stream passed over the mouth of the vessel. The reaction mixture is stirred magnetically with a 1 in. Teflon stir bar. Isophthaloyl dichloride (12.48 g, 61.48 mmol) in chloroform (100 mL) is then added to the solution and allowed to stir for 12 h. At the end of the reaction time, the solution is clear violet in color. The chloroform solution is washed with a 10% HCl solution (500 mL x 2, VWR) in a 2 L separatory funnel. The chloroform layer is transferred to a 1 L Erlenmeyer flask and dried by stirring over sodium sulfate (Na2SO4) for 1 h and filtered. Nitrogen is passed over the solution to evaporate the solvent and induce precipitation of the product. The product is allowed to dry further, open to air, for one day before characterization by melting point, IR, 1H NMR and MS. Yield without optimization: 12.51 g (72%).

But, hey, it’s all natural. Yes, I know that everything is made of chemicals, but nothing in the synthesis of OSR#1 appears to come directly from anything that is eaten. Sullivan gave a good counterexample to Haley. Basically, he suggested that we imagine a pill containing both vitamin C and vitamin D. Both are regular dietary constituents, and if they were put into a pill together they would still act individually because they are separate chemicals. They don’t undergo a chemical reaction to be joined with chemical bonds, as the benzoate and cystamine do. In fact, if you made a pill containing sodium benzoate and cystamine together, do you think they’d work as a chelator the way that OSR#1 does? If you answered “no,” you’d be right, because when put together in a pill they do not undergo a chemical reaction to form OSR#1. That takes chemical synthesis as described above to take the constituent groups and put them together to form a new molecule that didn’t exist before.

Yet Haley wants you to believe it’s all a perfectly natural part of the diet, just put together as a supplement. How stupid does he think you are? Jenny McCarthy-grade stupid apparently. Burning Man-sized flaming stupid, apparently. So stupid that you don’t have two neurons to rub together were it not for the spirochete connecting them. If I were in the anti-vaccine movement, if I really believed that vaccines caused autism, I’d be profoundly insulted by what Haley has done and how he has justified it.