Jan 19 2010

Tribune Covers Autism “Supplement” Scandal

As part of her series on autism quackery, Chicago Tribune writer Trine Tsouderos has written another eye-opening article – this one about the drug OSR#1 that is being given as a “supplement” to children with autism.

The story highlights what I have been writing for years – that the current supplement regulation in the US under the Dietary Supplement Health and Education Act (DSHEA) is an anti-consumer farse.

OSR#1 is a drug. It is a compound that was manufactured by a company for its pharmacological activity. They claim it was developed as an anti-oxidant, but the Tribune reports that the compound may have originally been developed as an industrial chelator – a compound that binds heavy metals to clean them from soil or industrial spills.

OSR#1 is being marketed now as a “supplement”  with claims that it is an antioxidant. But it is being used by parents in the autism community with the (wink wink, nod nod) understanding that it is a chelator, to treat presumed mercury toxicity as a cause of autism (a disproven hypothesis).

Even the antioxidant claims seem bogus. The company claims OSR#1 scavenges hydroxyl radicals, but as Vanderbilt’s Roberts is quoted in the Tribune:

“Hydroxyl radicals are the most reactive radicals that are formed,” he wrote to the Tribune. “They oxidize everything, so in essence all molecules are hydroxyl radical scavengers.”

So in essence the regulations that we have now allow for a company to take an industrial chemical, market it as a “supplement” with trumped up antioxidant claims (the latest buzz word), and yet the market for the drug is children with a serious illness, and the effect of the drug is a powerful pharmacological effect (chelation) that is normally only done under a doctor’s supervision because of the inherent risks. This is all done without providing any evidence for safety or efficacy.

According to the Tribune the FDA is looking into the matter  – and says that the company is supposed to provide safety data (which does not mean necessarily research – just information as to why the compound can be expected to be safe, which can be nothing more than – it’s been used for a long time). However, the company has not provided the requisite information, and has not responded to the Tribune’s request for safety data.

All of this, in my opinion, seems like a conscious effort to drive a drug through the giant “supplement” loop whole that DSHEA has created in the regulation of drugs in this country.

Now, chemicals developed as powerful chelators are magically regulated as if they were food because the company slaps the latest supplement buzz words on their website.

DSHEA is broken. It needs to be fixed.

Hopefully the FDA with get a little more proactive, now that some public attention is being shown to this scandal. But the FDA famously lacks resources and teeth enough to deal with all the supplement scams that are out there. The public, and in this case vulnerable children, are left without even the most basic protections from potentially harmful and almost certainly worthless compounds.

30 responses so far

30 thoughts on “Tribune Covers Autism “Supplement” Scandal”

  1. provaxmom says:

    What I like most, is that despite all the negative press, personal attacks and even lawsuits that Amy Wallace endured, that Trine Tsouderos still stood up and wrote and published the article.

  2. superdave says:

    It’s very telling that in the comments on the tribune website for that article, there are very few pro OSR comments, even among anti vaccine commenters.

    The facts simply speak for themselves. I don’t know how anyone could defend this.

  3. CrookedTimber says:

    Wow, very frightening for the children being treated as lab rats. If this isn’t endangerment, I’m not sure what is.

    Until I began reading this blog (and others) a couple years ago I had no idea that the supplement industry was so lawless. I think this message needs to reach more people.

    provaxmom – good call. Trine Tsouderos is really showing some backbone to continue to get the word out in the face of the anti-vaccine movements recent litigations.

  4. kikyo says:

    Hopefully this article will make a difference, but my guess is that “toxins” aren’t the real fear that parents who turn to alternative remedies have. I think the underlying reason that parents turn to alternative therapies is because of the measure of control it gives them over their child’s care, as opposed to letting a doctor prescribe drugs and make a treatment plan. With alternative therapies, they choose what their child takes. They may even go so far as to be allowed to control what their child eats, wears, etc and feel that these decisions make some difference to their child’s health. It is probably a psychological crutch when dealing with a problem that makes them feel so helpless.

  5. daedalus2u says:

    I think that many of the curebie parents want a magical tranformation, a transformation that no reputable health care provider will give them, but a transformation that quacks promise can be achieved all the time, if you just practice their woo.

  6. sonic says:

    Two questions-

    1) How has mercury toxicity as a cause of autism been disproved? What is the study that makes that claim?

    2) To what degree is the article cited here about OSR#1 an exercise in false dilemma? (Certainly we could start with the headline…)

  7. Sonic – I know you have followed my blog long enough to know the answer to #1. It is, of course, no single study, but many studies, summarized here: http://sciencebasedmedicine.org/reference/vaccines-and-autism/

    Collectively, these studies are sufficient to reject the mercury-autism hypothesis, which was never very plausible in the first place.

    Regarding point #2 – I, too, criticize bad headlines, and that headline is a false dichotomy. But journalists don’t write their own headlines.

    But I disagree that the point of the article is a false dilemma. Sure, an “industrial” chemical could also turn out to be useful to treat a disease or disorder, even autism. The point is how OSR#1 is being marketed and regulated. If OSR#1 can be considered a “supplement” – then the word “supplement” has no coherent meaning, and certainly does not mean what the public likely thinks it means.

  8. ChrisH says:


    How has mercury toxicity as a cause of autism been disproved? What is the study that makes that claim?

    First, what evidence is there that autism is caused by mercury toxicity? Where would kids get that mercury? By the time the very bad paper was published in “Medical Hypotheses” the use of thimerosal was being removed from pediatric vaccines, which had absolutely no impact on the numbers of autism diagnoses.

    There is not one study that makes claims that autism is not mercury toxicity, there are several (another thing is that genuine mercury toxicity is very different from autism). Here is a two page list of studies on thimerosal going back to 1999, covering several countries:

    If you need more, just go to PubMed and look. You should also go to your local library and check out Paul Offit’s book Autism’s False Prophets, which has a detailed explanation of the controversy and the science (including the correction of flaws in one study, page 93 of the hard back edition). You can also check the articles in relating to autism and vaccines here:

    How is the title “OSR#1: Industrial chemical or autism treatment?” a false dilemma? You are not being a given of choice to make a decision between two different things. Here the title refers to what is OSR: Is it an industrial treatment or is it an autism cure? Then it goes to explain that it is an industrial chemical that is being given to children, even though its safety has not been tested on children.

  9. provaxmom says:

    I read this blog post as well as Orac’s and followed the links provided on both (and wish I hadn’t!). I’m still amazed at this–I’m assuming that all these AoA parents, GR parents, etc., that their kids are all receiving the same therapies as my child. Speech, OT, PT, etc. It still amazes me that time and time again, these parents completely dismiss (by refusing to acknowledge) the value or successes of those therapies. The gains or progress that their child has is always because of some supplement, or special diet, or because they stopped vaxing…….they never ever, not even once, give credit to a teacher or therapist. I’d be really pissed off, if I was a special ed teacher who spends day in, day out, with these kids, and not even one time can the parents give you a public “thank you” or acknowledgement of your efforts.

  10. sonic says:


    I agree that there has been no link to mercury in vaccines and autism. (Or vaccines and autism at all). I agree that there has been no link to autism and increased levels of mercury in the blood (on the contrary–see study below)

    However, this does not disprove that mercury is a cause of autism. Consider that we could say that the level of peanut is the same in 100 people. This would not disprove that the person who was struggling to breathe didn’t have a problem with peanuts just because the other 99 were not having any problem.

    Regarding false dilemma-

    I know the author probably didn’t write the headline, but

    “An industrial chemical developed to help separate heavy metals from polluted soil and mining drainage is being sold as a dietary supplement by a luminary in the world of alternative autism treatments.”

    is the opening of the story and in this case the headline is a pretty good summary of the first half of the article.

    (I think there are other examples- e.g.- either the FDA says it’s good or it isn’t- seems a basic premise…)

    Consider that the article contains no information about any actual person who has been harmed or helped by the treatment. What am I supposed to be basing my opinion on?

  11. sonic,
    “However, this does not disprove that mercury is a cause of autism. ”

    Actually as science goes, it sort of does. You’ve been around here long enough that you should understand how science works. We can safely say that mercury is not a significant (statistically detectable) cause of autism, and if it is a cause at all, it’s effect is so minuscule as to be undetectable. Couple that with a complete lack of a plausible biological mechanism, and you can pretty much close the book on mercury as a cause of autism without loosing a wink of sleep.

    As a side note: I am not aware of any studies that disprove tiny elves or vacuum fluctuations as causes of autism; shall we seriously consider any and all speculations of causes of autism that have not been disproved?

  12. sonic says:

    You need to re-evaluate your position–

    From the article I cited-

    “The researchers cautioned, however, that the study is not an examination of whether mercury plays a role in causing the disorder.

    “The bottom line is that blood-mercury levels in both populations were essentially the same. However, this analysis did not address a causal role, because we measured mercury after the diagnosis was made.” ”

    You are suggesting that the researchers at UC Davis don’t know how science works.
    I know of no study that doesn’t suffer from the same difficulty- perhaps you can point one out.

    Further you seem to imply that ‘mercury is to neurological disorder as tiny elves and vacuum fluctuations are to neurological disorder’. I know that you are not that ignorant- so what is the point?

  13. sonic,

    Unlike some people, as a critical thinker, I do re-evaluate my position, every time new information comes along. So far, there has been nothing compelling enough to change my position.

    “I agree that there has been no link to autism and increased levels of mercury in the blood (on the contrary–see study below)

    However, this does not disprove that mercury is a cause of autism.”

    Your link was provided in the context to support your claim that there has been no link shown. If you intended to use the link to support your claim for mercury not being disproved as a cause of autism, you should have placed the link after that claim..

    “You are suggesting that the researchers at UC Davis don’t know how science works.”

    You are inferring something which I neither suggested or implied, but thanks for the straw man. I have no problem with what the researchers at UC Davis said in that article. However, There is a vast body of research on the subject of autism and mercury beyond the UC Davis study, I stand by my statement.

    “I know that you are not that ignorant- so what is the point?”

    You can’t really be that ignorant or have such a superficial understanding of neurological conditions caused by mercury toxicity and neurological conditions such as autism that you are incapable of understanding the thought process behind my my analogy, so what’s your point? Would you have preferred I had used toxoplasmosis and thallium instead of elves and vacuum fluctuations?

  14. tmac57 says:

    The part of the article that caught my eye was this:
    “A year after the FDA requested answers about the safety of Haley’s product, an autism group interviewed him about OSR#1. In the interview, posted on YouTube, Haley warns parents to be exacting when choosing what to give their children.

    “Parents should know if you can’t test and show the efficaciousness of anything you are taking for your child, don’t do it,” he said. “There are so many snake oil salesmen out there, it’s just incredible.” ”

    This just proves what a hypocrite Haley is. And it is hard to believe that any concerned parent of an autistic child would consider for a moment giving their child this substance without any peer reviewed research to back up it’s safety,much less what they coyly imply it’s efficacy is.

  15. eyesoars says:


    You can stop trolling now. The removal of mercury from childrens’ vaccines, if the mercury theory were true, would have yielded a substantial decline in its incidence over the last decade. That hasn’t happened. The mercury-causes-autism theory is *still* dead.

    At this point, the evidence is conclusive that aspartame or HFCS or any
    other common chemical or drug introduced into general usage in the last
    30 years is much more likely to be causing autism.


    On the other major topic, “supplements”, there is essentially no regulation. As a supplement manufacturer, you can put pretty much anything into a supplement and sell it, just so long as you don’t make specific claims of efficacy.

    Thus there was the tryptophan/eosynophil scandal of several years ago, where contaminated tryptophan maimed quite a few people. It’s very reminiscent of the situation that allowed the Massengill Corporation to poison a few hundred children in the 1930s:


    The company marketed a product that was sulfanilamide (the first effective antibiotic) dissolved in diethylene glycol. No punishment was meted out because the label listed both ingredients, despite the fact that it killed over 100 children particularly gruesomely (by kidney failure). What punishment was meted out (a fine of $16,800) was ostensibly due to it being falsely advertised as an elixir when it contained no alcohol.

  16. KathyO says:

    Karl is right about the non-link between mercury and autism. But the headline of that article he posted didn’t go far enough. It’s not that autistic kids had the same mercury levels as other kids. What it actually said was:

    At the outset, the children with autism appeared to have significantly lower blood-mercury levels than the typically developing children. But children with autism tend to be picky eaters and, in this study, ate less fish. When adjusted for their lower levels of fish consumption, their blood-mercury concentrations were roughly the same as those of children with typical development.

    In other words, autistic children tend to have much less mercury in their systems than non-autistic children. Personally, I can’t see how anyone can keep up the mercury/autism facade after hearing this.

  17. Draal says:

    If anyone else is interested, here’s a link for those more interested in the origins of CSR#1 and what the molecular structure looks like (aka MetX, CT-01, N,N’-bis (2-mercaptoethyl)isophthalamide, Benzene-1,3-diamidoethanethiol (BDETH2)).

    Neither 1,3-benzenediamidoethanethiol nor N,N’-bis (2-mercaptoethyl)isophthalamide appears in the Chemical Abstracts Service (CAS) Registry. Neither chemical name has a corresponding Materials Safety Data Sheet; neither has been thoroughly tested to determine its toxicity and pharmacodynamics in human beings.

    That’s a bit scary.

    comment #8 is interesting and explains why CSR#1 is being marketed as an antioxidant.

    And some related skeptic reporting.

  18. Draal says:

    my missing quote from comment #8:
    I believe it is unfortunate that he decided to market it as an antioxident. It is a mistake because it makes it appear he is not being straight forward. Fact is, the supplement is high in glutathione which is in fact an antioxident. So he is correct.

  19. sonic says:

    I’m sorry. There has been some confusion. I thought that your comments were directed to the statements made in the link I provided.

    I would agree with the statement that the link between mercury and autism has not been shown. I would further agree that if mercury does cause autism we currently have no evidence to support that.

    This is a different from the claim that causation has been disproved.

    As far as the idea that mercury poisoning and autism might be linked–


    For fetuses, infants, and children, the primary health effect of methylmercury is impaired neurological development….Impacts on cognitive thinking, memory, attention, language, and fine motor and visual spatial skills have been seen in children exposed to methylmercury in the womb.
    For elemental mercury–
    Symptoms include these: tremors; emotional changes (e.g., mood swings, irritability, nervousness, excessive shyness); insomnia; neuromuscular changes (such as weakness, muscle atrophy, twitching); headaches; disturbances in sensations; changes in nerve responses; performance deficits on tests of cognitive function.

    Since autism is a ‘spectrum’ disorder, it does not seem to me that the well known symptoms of mercury poisoning rule out the possibility that mercury has something to do with autism.

    So my complaint is with the claim of ‘disproof’- a very specific claim.

    I also thing the article relies on false dilemma rather than evidence- has anyone ever had any problem with the treatment reported on?

  20. sonic says:

    Kathy O, eyesoars-
    people who die of anaphylaxis often have less peanut butter in their system then those they are with. Does this disprove the hypothesis that peanut butter caused the anaphylaxis?

  21. ChrisH says:

    Trying to get back on topic. Suppose a child did the same that that this man did, and actually had heavy metal poisoning (do note that he recovered completely in just a couple of months). Do you think that giving Haley’s untested powder would be a good thing or a bad thing?

    sonic, stop ignoring the large body of work that has been presented to you. At a minimum read this explanation of the difference between autism and mercury poisoning: Thimerosal and Autism?. Until then try to comprehend that …

    … the science has been done, the link between vaccines and autism does not exist. It is a dead link… “It’s not pinin’! ‘It’s passed on! This link is no more! It has ceased to be! It’s expired and gone to meet its maker! It’s a stiff! Bereft of life, it rests in peace! If you hadn’t nailed it to the perch it’d be pushing up the daisies! Its metabolic processes are now ‘istory! It’s off the twig! It’s kicked the bucket, it’s shuffled off its mortal coil, run down the curtain and joined the bleedin’ choir invisible!! THIS IS AN EX-LINK!! ” (hat-tip to Monty Python and the dead parrot sketch)

  22. HHC says:

    I bet Boyd Haley is doing a brisk supplement business in Harkin’s Iowa. Its economic base is agriculture. There’s no mining or major manufacturing there. But what the heck!

  23. sonic says:

    try to understand, I have not suggested that there is a link between autism and vaccines. In fact I have specifically stated that I do not believe there is one.
    No need to defend something that has not been questioned.

  24. Shockstrut says:

    So given we are all apparently in agreement that vaccines do not cause autism … why mercury in particular? Agreed, in sufficient doses, it can cause the list of problems sonic presented above, but so do heaps of other things. What is it with the mercury?

  25. eiskrystal says:

    try to understand, I have not suggested that there is a link between autism and vaccines. In fact I have specifically stated that I do not believe there is one.

    Thus you wasted perfectly good digital bits waffling about nothing so you could think you’re superior for telling us all how good science should be done.

    Any effect of mercury from vaccines would be swamped by the mercury found in fish. So even if there was a a link, it wouldn’t matter in the scheme of things. Its like complaining about the lack of tests on m&m’s while letting them eat peanut butter.

  26. Draal says:

    Here’s my take. Testing a hypothesis proves certain explanations are false leaving one or more explanations that have not been proven false, yet (inferring that one or more explanations more more likely to be correct). Science does not prove one hypothesis to be 100% correct but will disprove certain hypothesis to be incorrect.
    Now, concerning mercury and autism. There has not been rigorous testing to indicate that mercury does or does not causes autism. BUT… reality sets in. It would be highly improbably that such testing would be conducted on human infants by purposefully exposed to elemental, methyl-mercury or ethyl-mercury (my opinion on the definitive test). So… it is impractical to demand absolute proof that mercury does not cause autism. We can logically infer relationships from the growing body of evidence, particularly from the discontinuation of ethyl-mercury in most vaccines and the apparent non-decrease in the appearance of autism.

  27. Saying there is no evidence to support the claim of a link between mercury and autism is not a sufficient summary of the situation. There is evidence for the absence of a link. That evidence has crossed the threshold to where we can reject the hypothesis. It is acceptable layman’s colloquial to say that such a link has been disproved by the evidence.

    Regarding mercury and neurotoxicity – no one denies this. But clinical neurologists (like me) distinguish specific and non-specific neurological signs and symptoms. There are no specific features that are shared by mercury toxicity and autism. It’s a poor medical hypothesis. Not impossible, just not very plausible.

    It’s as good as saying – hey, mercury causes neurological stuff, and Parkinson’s disease is a neurological thingy, so maybe mercury causes Parkinson’s.

  28. stargazer9915 says:

    Seems like someone has touched on Sonic’s ‘sacred cow’. All the proof that is needed is pretty much been put out there by the commentors, but it seems to have little effect.

    This would be a good topic for a 5×5 episode. (Hint to Dr Steve)


  29. sonic says:

    Allow me to apologize–

    The word ‘disproof is being used as ‘acceptable layman’s colloquial’ for the situation. I thought that was a scientific and/or logical claim.
    My bad.

    Regarding mercury poisoning and autism-
    I agree, not impossible- not very plausible.
    But there is a world of difference between those two and I misinterpreted some statements to imply that this difference doesn’t matter.
    My bad.

    I admit that I habitually doubt, question, and disagree with assertions (especially of certainty). My instinct is to question generally accepted conclusions.
    I can be a pain in the neck.
    (That last is not an apology.)

  30. Neuroskeptic says:

    The scheme of selling a drug as a “supplement” is nothing new… in the world of recreational drug users. There are various new compounds that the law hasn’t got around to banning yet, but in most countries there’s a general rule that you can’t sell anything as a medicine for human consumption without the proper authorization. So people sell these chemicals as “air fresheners”, “plant fertilizers”, “vitamin supplements”, etc.

    Good to see the autism biomedical crowd are up with the latest methods.

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