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Should We Study Chelation for Autism?

The National Institute of Mental Health (NIMH) supports doing a study on the effects of oral chelation therapy in autism. The proposal is highly controversial, is drawing criticism from many scientists, but has popular support among parents who believe this type of therapy might help their children with autism. The proposal raises many questions about the ethics of biomedical research.

Chelation and Autism

Chelation therapy is a legitimate FDA approved treatment for heavy metal poisoning. The drugs used for chelation, such as disodium EDTA, bind to heavy metals so that they can be removed from the body. Chelation drugs can be given either orally or intravenously. The treatment is somewhat risky because it can also remove needed electrolytes, like calcium, from the body or causes shifts in the electrolytes that can cause arhythmias and changes in brain function. There are reported cases of cardiac arrest and death due to chelation.

Chelation therapy has a long history of quackery – not for its intended use but for other uses for which there is no evidence. The classic example of this is the use of chelation therapy to treat atherosclerosis to prevent heart disease. This claim persists despite the utter lack of evidence for efficacy and the fact that all proposed mechanisms have been shown to be flawed or false.

In the last decade the belief that mercury in some vaccines (mercury-containing thimerosal was removed from routine childhood vaccines in the US by 2002) might be linked to autism. The scientific evidence clearly shows this is not the case (as I have discussed in many previous posts). But belief persists despite the evidence, mostly among anti-vaccinationist ideologues. But many earnest parents, just wanting to help their autistic children, have been caught up in the pseudoscience and conspiracy-mongering.

Naturally, belief that mercury causes autism has led to claims that chelating mercury cures autism. There is no evidence for this and there is no basic-science reason to suspect this might be the case. Now proponents of this treatment want the government to sponsor a study based upon their unsubstantiated treatment which in turn is based upon a false belief regarding the cause of autism.

The Ethics of Medical Research

Medical research has always been ethically tricky – it requires giving humans experimental treatments with unknown benefits and risks. But over the last few decades (originally triggered by Nazi abuses) there has been evolving ethical standards for medical research. They include many principals, among them that any experimental treatment must be more likely to help the subjects of the study than to hurt them, prior research must show that the treatment is probably safe – or at least is not highly toxic or dangerous, and there must be a plausible belief that the treatment is likely to work. Further, study subjects must be given full informed consent, and regardless of the treatment being studied they must receive at least the minimal current standard of care. In other words, you cannot withhold proven therapies in order to study unproven ones.

For this reason many consider using chelation therapy for autism to be unethical. There is insufficient scientific justification to believe that it might work, at least not enough to justify the safety concerns. Subjecting children to a risky treatment that probably doesn’t work is certainly ethically dubious.

But proponents of the study cite the fact that many parents are already using chelation therapy for their autistic children. Among them is Dr. Thomas Insel, Director of the NIHM. He is reported as saying:

“So many moms have said, `It’s saved my kids.’”

“This is an urgent set of questions. Let’s make innovation the centerpiece of this effort as we study autism, its causes and treatments, and think of what we may be missing.”

This justification comes up often with so-called alternative medicine – people are using it and they want choices, so we should study it. This turns out to be a very poor justification, however. The National Center for Complementary and Alternative Medicine (NCCAM) was founded on this idea – but a decade of research and hundreds of millions of dollars spent on this precise form of wishful thinking has lead to nothing. All of the NCCAM research has not added one solid treatment to the arsenal of scientific medicine, nor has it convinced CAM proponents to abandon a single failed therapy. That is the very purpose of medical research – to change practice. Research into dubious therapies promoted by those who eschew science-based medicine does not achieve that purpose.

Therefore, such research is a waste. But it is more than a waste – it subjects the people in the study to the risks of medical research without any benefit to society. If the treatments are highly implausible, then the probability is there was no benefit to the subjects themselves either. Such research seems to be all expense and risk and no benefit.

This puts advocates of science-based and ethical medicine in a difficult position, however. It is hard to argue against doing research – more information always sounds like a good idea. Refusal to even research a question can easily be made by fanatics to seem like suppression of the truth. This can turn the public against those who are most sincerely advocating for their rights, ironically. This motivates some, like Insel, agree to do the research – but this is a sucker’s bargain. We have been there before – doing the research accomplishes nothing because the people who need to be convinced are not basing their conclusions on scientific evidence in the first place.

What about all those parents who feel that their children were helped by chelation? Frankly, this is not compelling evidence. Again – we have been there before with similar treatments. Many parents thought their children were helped by psychomotor patterning, but the evidence showed conclusively that they weren’t. The scientific community abandoned the treatment – but the true believers cling to it still, even after three decades.

Children with developmental and neurological disorders will often improve as they age. This background maturing can easily be mistaken for improvement in response to a treatment. There is also the numerous psychological effects that highly motivate parents to believe their children are being helped, even when they aren’t (such as confirmation bias and expense justification). The simple fact is that history has shown that anecdotal evidence is not reliable. If a treatment is plausible it may be enough to justify doing controlled research. But for risky and implausible treatments it is not enough. Otherwise we would be spending hundreds of millions of dollars studying numerous implausible modalities to no end (wait a minute – we are doing just that with the NCCAM).

Doing this kind of questionable research is also risky. With a study of this size there is a real chance of a false positive – that the study results will be positive even if the treatment does not work. If that happens it will embolden the proponents of chelation for autism and lure more children to this dubious treatment. One small study is not enough to settle a scientific question or establish an unlikely therapy – so a false positive study will lead to a larger follow-up study. That means more money, more time, and more children subjected to chelation as part of the experiment.

This all stems from doing research on an ideologically charged question. Ideally medical science should take its time with a question, conservatively interpret existing research, and carefully consider the next step. This is not possible when there are groups outside the scientific medical community essentially kibitzing the science. Regardless of their intentions, this taints the scientific process and leads to confusion. It creates a situation in which the public is likely to overreact to preliminary research – for example by demanding treatments that probably don’t work.

Conclusion

I am with those who say that this research is highly unethical. It is being promoted by a fringe movement that has a history of anti-scientific attitudes. There is no reason to believe that the results of the research will settle anything, and it is very unlikely to be truly positive given what we know about autism. Doing this type of research in the hopes of convincing the ideologues is a fool’s notion. Don’t say I didn’t tell you so.

Posted in: Clinical Trials, Medical Ethics, Neuroscience/Mental Health, Vaccines

Leave a Comment (83) ↓

83 thoughts on “Should We Study Chelation for Autism?

  1. David Gorski says:

    Amen.

    That Dr. Insel would say something along the lines of “”So many moms have said, `It’s saved my kids’” as a justification for this study shows that he is not qualified to be the head of NIMH. (Apparently he does not know the difference between testimonials and real medical anecdotes.) Also, Dr. Susan Swedo, the principal investigator for the study, has also shown some proclivity for dubious medical hypotheses in the past.

    Personally, having worked on getting clinical trials through the IRB, I’d give my eyeteeth to see the actual protocol under discussion. Specifically, I’d love to see the preliminary data included in the protocol as part of the scientific justification for this trial. It’s got to be really, really thin. I also agree with you that this proposed trial is highly unethical, particularly taking into account the extra obligations under the common rule for IRBs to protect vulnerable populations from shoddily-designed and unethical human experimentation. If there’s a population much more vulnerable than autistic children, I’m hard-pressed to think of one. In a way, though, the news that the trial is on hold heartens me, because from a couple of colleagues I’ve heard it through the grapevine that it is indeed the IRB that’s holding up the trial because of safety concerns and concerns that there is no good evidence for a potential benefit. One can only hope the IRB at the NIH stands tall against the political pressure that will no doubt be brought to bear.

    Clearly, politics is the only reason this trial isn’t totally dead. On science and ethics alone, there’s no way this clinical trial should have ever been approved, much less funded. I blame the decision to include “advocates” on the steering panel mandated by the autism research bill passed last year. No doubt the NIH was trying to be “inclusive” and perhaps even coopt the advocates, but this strategy has backfired miserably.

  2. orDover says:

    What makes this study seem even more useless is the knowledge that those supporting Chelation Therapy won’t stop advocating it even if the study is clearly negative. If there was a chance that the study could be done and change these people’s minds, if it might officially put an end to the Chelation nonsense, then it might be worth it, but knowing full well how dogmatic thought operates there is nothing to be gained.

  3. Calli Arcale says:

    *grrrr*

    What fools. How could the NIH think that a negative study would discourage the chelationists one bit? Chelation for atherosclerosis was the focus of studies fifty years ago, which found no benefit whatsoever — yet today, chelationists are still making a lot of money chelating people to clear out their arteries. It will be the same with autism. Lots of taxpayer money will be spent and, more importantly, childrens’ lives will be put at stake, and it will achieve NOTHING like the lame-o justification put forth for this study.

    And what’s that about “being a centerpiece of innovation”? It shouldn’t be about innovation. It should be about improving the lives of patients. Sometimes that means innovation. But if the focus is innovation in and of itself, then we lose sight of the patient and just spend our time congratulating ourselves for being so clever.

    The arrogance of such an attitude is truly astonishing.

    The study should be killed immediately. Write your congressmen!

  4. Fifi says:

    orDover – Not only is there nothing to be gained but there’s actually something to be lost. Even conducting a study of this kind gives many lay people the impression that science/scientists considers something legitimate enough (and probably enough) to be worth studying. Time and time again, I’ve seen proponents of CAM and woo use this to claim legitimacy and to be science based (even when the studies prove their claims untrue!). When it comes down to it, evidence is lost on those engaged in faith healing. This is simply because faith, by its very nature, is about believing in something EVEN WHEN all evidence points to it being untrue. Which is not to denigrate faith, sometimes we need to believe in success despite the odds or take a leap of faith. However, denial of reality (saying there are no odds) isn’t the same as playing the odds.

  5. “I’d give my eyeteeth to see the actual protocol under discussion.”

    Your wish is my command:

    http://www.circare.org/consents/06-M-0238_protocol.pdf

    (Well, not really mine, of course). Here’s the consent form:

    http://www.circare.org/consents/06-M-0238_consent.pdf

    More later.

  6. Joe says:

    I have wondered a couple things about this.

    First, the simplest experiment is accurate and non-invasive as it is based based on hair and/or urine analysis. Is there any correlation between mercury (Hg) load in affected vs. unaffected individuals? Apparently, only one such study has been done (Wecker L et al. J Mental Defic Res 1985; 29: 15–22) and the result was that no association between Hg and autism was seen. Unless that result is overturned, the study in question is unwarranted.

    Second, the half-life* of ethyl-Hg (in thimerosal) is said to be approximately a week. http://www.pediatrics.org/cgi/content/full/114/3/793 Even if the vaccinations may have approached the limit of safety (as discussed in the article, not a conclusion that the vaccinations are unsafe) the rule of thumb is that the Hg is gone after 6 half lives (98% of the Hg is gone). That’s 6 weeks; chelation more than 6 weeks (let alone years) after the shots is idiotic!

    *The time it takes for the body to naturally clear ethyl mercury.

  7. TheProbe says:

    The real evidence of the effect of chelation on cognition shows that it does not work.

    http://pediatrics.aappublications.org/cgi/content/full/110/4/787

    I cannot find any evidence that chelation *reverses* the damage done by heavy metal toxicity. None. With the half-life of EHg being so short, there is no rational reason to believe that chelation will have the slightest positive effect on the child.

    This “study” is purely political, and is meant to satiate the Mercury-Borg. They are resistant to facts, and their ignorance is irreversible.

    It will only be another endeavor that puffs up their false self-importance.

  8. Matt says:

    Recent articles about chelation have numerous internet ads about chelation therapies–largely the discredited coronary disease therapies.

    At a recent parent convention for autism, there was a talk by one of the people in charge of one of the alt-med organizations, DAN!. Stan Kurtz was talking about how the AAP is committed to “evaluating” DAN! protocols. He implication was that there could be two outcomes: (1) the AAP indicates there is benefit or (2) the AAP says there isn’t benefit and then DAN! knows where and how to attack.

    In the meantime, DAN! gets some credibility for association with AAP.

    The analogy here is clear–there is some credibility given to the idea of chelation due to the fact that NIH has agreed to even consider it. A negative result would likely be interpreted as “flawed” and a positive or neutral result would be hailed as a victory–even if a later study with greater statistical power were to discount the results.

    Kimball: thanks for posting that. I can’t believe that they are leaning on DAN!/ARI surveys and reports by Amy Holmes.

  9. Joe says:

    I was sloppy in my * explanation of half-life. It is a way of describing the natural elimination of something. It refers to the time it takes for half the substance to be removed. After one half-life, 1/2 is gone, after two half-lives, 1/2 of that (or 3/4) is gone, and so on. I recognize the blog authors know this, it is for the general reader.

  10. daedalus2u says:

    The protocol calls for not chelating anyone with undetectable levels of heavy metals (less than 0.1 microgram/dL). The antimercury crowd will say that these are precisely the most mercury toxic children because there is no measurable mercury in their blood.

    With no measurable mercury in their blood, all the mercury in their bodies must be where it cannot be seen, their brains must literally be floating in mercury.

  11. overshoot says:

    daedalus2u:

    The protocol calls for not chelating anyone with undetectable levels of heavy metals (less than 0.1 microgram/dL). The antimercury crowd will say that these are precisely the most mercury toxic children because there is no measurable mercury in their blood.

    He’s not kidding, people. The top theologians of the CoVM have explained the lack of detectable mercury in autistic kids by discovering that autistic kids are unable to transport mercury from the brain to the bloodstream, thus low levels are proof that it’s there.

    Boggle.

    The nice thing about this “explanation” is that there’s no ethical way to test it short of an autopsy.

  12. Maurine Meleck says:

    You people have no idea what you are talking about. It’s obvious you have never chelated an autistic child and seen incredible results or have ever recovered an autistic child due to chelation therapy.
    Why do you waste your time writing on these blogs when you have no stake in this controversy?

  13. AntiVax says:

    Chalation therapy would expose the mercury cause of autism and alzheimer’s, both iatrogenic diseases. Go figure. Not to mention its use for heart disease
    http://www.whale.to/w/Chelation.html

  14. HCN says:

    In any discussion involving science or medicine, citing Whale.to as a credible source loses you the argument immediately.

    http://rationalwiki.com/wiki/Scopie%27s_Law

  15. overshoot says:

    HCN, old friend, I will remind you that “antivax” is none other than your old acquaintance from MHA, John “Whale” Scudamore.

    So citing Scopie’s Law at him is, like, redundant. Of course, him citing whale.to is pretty much an appeal to his own authority.

  16. HCN says:

    I know, but I figured it was worth it for anyone else who was reading this.

  17. durvit says:

    Daedalus and overshoot outline what has been disturbing me about this. Given that the hand-wave explanation is that there is negligible mercury in the bloodstream because it is all sequestered in the brain, how is chelation supposed to remove it from the brain?

    Serious question – is this supposed to be the chemical equivalent of wrapping a kitten – the chelating agent coats the mercury with something to tame it and then it can carry it out? Or is it more Tale of Two Cities? The chelating agent and a friend sneak across the blood-brain barrier; they disguise the sequestered mercury, the mercury is escorted out to freedom while a (presumably benign) friend stays behind (drinking polyjuice?) until the body deals with it?

  18. DavidCT says:

    overshoot

    You don’t need an autopsy – a brain biopsy should do. Considering what these mercury fanatics are willing to do to these poor kids in an attempt to justify their nonsense, such a proceedure would not be out of line. You could have the severly disabled agree to the proceedure by using a ficilitator(FC).

    Once you throw the science out of research, there is ample opportunity to hurt real people. When it comes to woo, there are no ethics that mean anything.

  19. daedalus2u says:

    There was a study that did look at levels of mercury in brain postmortem in ASD and controls. The study was very small and showed only small absolute differences that were non-significant.

    There are populations with measured brain mercury levels that are much higher. I think there was a study of Japanese or Korean brains (where there was more fish in the diet) that was ~5x higher than what was observed in the ASD brains in the small study.

    There have been studies that have looked at partitioning between brain and blood (and other organs), and never has there ever been observed to be a non-proportionality, in any organism.

    In other words, what the antimercury folks are calling “mercury efflux disorder”, which posits a 3 or 4 order of magnitude difference in partitioning between brain and blood or brain and hair (so you could have toxic levels in the brain with negligible levels in blood or hair), has never been observed in any organism (human or other). It is completely at odds with much that is extremely well known about mercury physiology.

    Children in times past were exposed to much more mercury than was ever in vaccines. Teething powders once contained a grain of calomel, 65 mg of HgCl. Tens of millions of doses were sold each year. One company sold 30 million doses in one year. Many tens of millions of children were exposed to many thousands of times more mercury from teething powders than were ever exposed to mercury from vaccines.

    Mercury poisoning in children shows up as pink disease. Over 1000 children died from pink disease which we now know is mercury poisoning from teething powders. When the mercury was removed, pink disease disappeared.

    65 mg of HgCl is 55,000 micrograms of mercury. Compared to that, the 12 micrograms in a vaccine is negligible.

  20. Calli Arcale says:

    You people have no idea what you are talking about. It’s obvious you have never chelated an autistic child and seen incredible results or have ever recovered an autistic child due to chelation therapy.
    Why do you waste your time writing on these blogs when you have no stake in this controversy?

    The “controversy” exists only in the minds of a few conspiracy theorists and the pour souls they’ve tricked into following them.

    Besides, why assume we have no stake? I have a child on the autism spectrum, and a brother who is autistic. I remember when he was little; his troubles started within a month of his first vaccinations (the three-month ones). Were the vaccinations to blame? No. For one thing, the mercury would’ve been completely gone by that time. (This was 1984.)

    He was never chelated. He never received Lupron. He was not placed on a gluten-restrictive diet. Heck, he didn’t even receive psychoactive drugs like Ritalin. Yet today he is a normal, functioning adult. He’s pursuing a career as a photographer. Awesome guy, modest to a fault, very “with it”, highly respected by his coworkers. It took years of customized therapy to help him overcome his difficulties, combined with any child’s incredible natural ability to learn and adapt. That therapy did not involve injecting him with hazardous chemicals on the off chance that they might do something beneficial. It involved patiently working with him, helping him to learn what he needed to know.

    Yeah, it’s not quick and it’s not easy. It takes serious dedication on the part of the family. I know it’s not what parents of autistic children want to hear; they are stressed out, and want something fast, relatively easy, and permanent. But it doesn’t work that way. It’d be like seeking a fast, magical treatment to help a pubescent child bypass the awkwardness of the junior high years. No matter what you do to the kid, he or she has to *learn*. And that takes time. It just does.

  21. Joe says:

    Calli,

    I tip my hat to you.

  22. Michelle B says:

    Moi aussi, Calli, Kudos! Just because one has an emotional stake in an illness, does not mean an evidence-based approach should be discarded to the wind. The same approach Calli described was used for a friend’s autistic son and it bore similar results.

  23. daedalus2u says:

    durvit, it is worse than that, there was a study of chelation of autistic children, run by the Geiers and some other DAN! quacks. They chelated 221 children on the ASD spectrum, and 18 “normal” control children. The only “indication” that the control children had for being chelated for mercury was that their parents presented them for chelation and had a willingness to pay. There were no symptoms, no known exposure, and no prior tests indicating elevated mercury.

    Case-Control Study of Mercury Burden in Children with Autistic Spectrum Disorders

    If you do a Google scholar search on that, a number of pdfs show up that you can download.

    They make a big deal out of finding “significant” mercury. If you do the calculations, the average mercury difference between the ASDs and “controls” was ~1.1 micrograms per day (assuming 20 kg child and 20 mg creatinine/kg/day). Over the 3 days of chelation, that was 3.3 micrograms. That is less than the average amount of mercury in 10 grams of canned albacore tuna (at 0.353 ppm n=399 FDA).

    How can the mercury in 10 grams of canned tuna be considered “significant” or important? This was average, some children showed zero mercury excretion.

    The authors only give averages which is highly misleading because the standard deviation exceeds the mean value showing the distribution is highly skewed.

    cases n=221 4.06 +/- 8.59, 0 to 58.65 for mean +/- std dev, low to high.
    controls n=18 1.29 +/- 1.54, 0 to 6.2 for mean +/- std dev, low to high.

    I tried to get the raw data so I could calculate my own statistics on it, but of course that request was refused.

    If the high is 58, and the mean is 4, that means that there must have been a lot more children with mercury levels below 4 than above 4. To balance out the single 58, you would need 14 at zero.

  24. Harriet Hall says:

    Maurine Meleck said,

    “You people have no idea what you are talking about. It’s obvious you have never chelated an autistic child and seen incredible results.”

    I have never used bloodletting for a fever and seen incredible results. For about 2 millennia, lots of doctors used it and believed they saw incredible results.

    Do you think modern doctors know what they’re talking about when they say bloodletting does more harm than good? Or do you think we should read Medieval testimonials and then try it for ourselves?

  25. Hermano says:

    S. Novella asks “Should We Study Chelation for Autism?”
    If you can, you should, and if you can not, you should not.

  26. Calli Arcale says:

    I have to disagree, Hermano. Just because something *can* be studied does not mean that it *should* be studied. Ignoring the problem of finite resources for research, there are ethical considerations. Many experiments impose risks to the test subjects. This must be considered when deciding whether or not to conduct a test. “Because we can”, or “because we want to be innovative” is not adequate. The potential benefit has to outweigh the risks to the test subjects. And that can be a tricky thing to weigh.

    Hypothetical example: should we do an experiment to determine whether or not people explode when exposed to the vacuum of space, or at least to determine exactly what physiologic changes occur from “sucking space”? Of course not. Such a study would be obviously unethical, since it would result in the deaths of the test subjects. As it happens, such an experiment *was* performed, albeit by accident. The Soyuz 11 crew were wired up for biometric telemetry when they initiated the reentry procedure for their spacecraft. Unfortunately, when the orbital module jettisoned, something caused a pressure equalization valve to open prematurely. Intended to equalize pressure with Earth’s atmosphere, it instead vented the cabin atmosphere to space. The crew lost consciousness in less than half a minute, and were dead by 112 seconds. Autopsies revealed brain hemorrhages, blood in the lungs, and nitrogen bubbles in the blood. You wouldn’t run an experiment to study that. You’d content yourself with the Soyuz 11 data, because to deliberately repeat the accidental experiment would be horrific.

    That’s an extreme example, obviously. I chose it because it was unambiguous. You don’t study things simply because you can. The benefit has to outweigh the risk, or it is a monstrous or at least seriously negligent thing to do.

    In the case of the chelation study, there is significant risk. Chelation isn’t something to mess around with — it’s very potent medicine, and dangerously indiscriminate. So you don’t give it to *children* unless there is a high likelihood of them benefiting enough to justify risking their health.

  27. DLC says:

    Short answer: No.
    Long answer: Chelation is a useful intervention under very specific and limited circumstances. Autism spectrum disorders are not one of those. Autism is not mercury poisoning. The symptoms are not alike.

    (note: I put this as simply as I can, for those who may not be fully informed on the subject)

  28. Matt says:

    I don’t get it. Looking out for the safety of kids is called not having a stake in this controversy?

    Let’s see, a neurologist doesn’t know what he’s talking about when we are talking about a potential treatment for the brain?

    Tell me, do you only use chelationists who have chelated their children?

    Of course, that is a perfect lead in to the Amy Holmes story. Didn’t she claim great gains with chelation only later to announce her departure from the public eye with comments about how her child’s situation belied the claims of progress?

  29. Harriet Hall says:

    Hermano said,
    “S. Novella asks “Should We Study Chelation for Autism?”
    If you can, you should, and if you can not, you should not.”

    We can study bloodletting. Should we?

  30. Maurine wrote: “Why do you waste your time writing on these blogs when you have no stake in this controversy?”

    Others have answered this but I want to chime in also.

    The very purpose of this blog is to advocate for higher scientific standards within medicine and to promote science-based medicine. We care about this because we are physicians – our oaths and careers are based upon bringing the best medical care to our patients and the public.

    The purveyors of unscientific medicine want us to shut up because we are doing our best to expose the fact that they want to remove the scientific standard from medicine to help them line their pockets or promote their ideology.

  31. Michael Barry says:

    Dr Novella or another doctor. This is a little off topic but I could use a moment of your time. My sister-in-law is one of the crazy anti-vaccine people. She just e-mailed me a video called
    VACCINATION THE HIDDEN TRUTH
    Now this is something she purchased as a pay per view. I haven’t watched it yet but I can only imagine what it contains. Do you know anything of this video and do you have any comments that I could slide to my sister-in-law about this video?
    It comes from vaccinationandvaccineinfo.org

    Any help would be appreciated. I have linked her to many of your vaccine posts, she just won’t budge. It was the Thermisol, now it is the toxins and the number of vaccines.

    Thank you in advance.

  32. Hermano says:

    H. Hall wrote “We can study bloodletting. Should we?”
    For what purpose?
    There must be a ton of data available from observing blood donors.

  33. Hermano says:

    Calli,
    I really liked the Soyuz 11 story.
    To remain in the Soviet vein, consider drinking vodka to celebrate brave cosmonauts.
    Should you drink it, or not?
    If you can, you should, if you can not, you should not.

  34. vinny says:

    I want to propose a new topic for Steve since his specialty is neurology. It always confused me to hear the rationale from neurologists for administering aspirin versus aggrenox, versus plavix in terms of secondary stroke prevention. Furthermore, the manufacturer claims that taking dipyridamole and aspirin in separate formulations rather than taking aggrenox is not as effective due to some “magical” property of aggrenox coating. The initial study showing a benefit to aggrenox versus aspirin was small and since then we have seen large scale studies confirming this benefit. However, how good are these studies when it has been shown that taking dipyridamole in addition to aspirin is not benefitial and therefore the rationale for even doing such studies was flawed? It also makes no sense to see a recommendation to switch a patient from aspirin to plavix or aggrenox in a patient with a recurrent stroke. Steve, could you discuss this topic for the benefit of other doctors who read this blog?

  35. Harriet Hall says:

    Hermano said,

    “For what purpose?
    There must be a ton of data available from observing blood donors.”

    Bloodletting was to balance the humours of people who were sick. Blood donors are healthy. Blood donor data is irrelevant.

    I was pointing out that just because we “can” study something doesn’t mean we “should” study it. We are wasting research dollars on treatments that have no better evidence or plausibility than we had for bloodletting. I hope even Hermano recognizes that a study of bloodletting for fever would be a useless waste of money. No, I can’t prove it doesn’t work. There is a tiny possibility that it does work; but there is also a tiny possibility that all the air molecules in the room will find themselves in the other half of the room and you won’t be able to breathe. And there is a significant probability that studying it would harm patients. Bloodletting killed George Washington.

  36. Calli Arcale says:

    I’m glad you enjoyed the story, Hermano. The Russian space program is one of my interests, and there are some fascinating stories — some deeply tragic, some amazingly triumphant, some amusing. Soyuz 11 is an interesting story. The crew had just finished the first ever space station mission, spending a month aboard Salyut 1. It would’ve been a complete success if that valve had stayed shut. Instead, tragically, the world got to learn what really happens when somebody gets spaced. The first change made to the Soviet space program was that all subsequent crews (to this day) have worn sealed pressure suits for the entire entry. We Americans did not manage to learn from Soyuz 11; twelve years later, Challenger exploded, and the crew all lost consciousness and died quickly in the rarified air at their altitude. (Not that suits would’ve saved them; the 200G impact with the water would’ve finished them in any case. They were doomed from the moment of SRB ignition.)

    Tangentially related, a Russian crew is about to step into space. They will be removing an explosive device called a pyrobolt from the Soyuz TMA-12 spacecraft. The last two Soyuz TMA vehicles had problems where the Plane 5 connector failed to unlatch, so the crew will remove the Plane 5 pyrobolt and manually unlock the Plane 5 latch so that it can’t contribute to another rough (9 Gs and spinning like a rifle bullet) ballistic reentry. Engineers still don’t know what caused the problem, but they’re hopeful that inspecting an actual pyrobolt that’s been on orbit for a few months might give them some clues. EVA is scheduled to begin in about 70 minutes. It’ll probably be carried live on NASA TV: http://www.nasa.gov/multimedia/nasatv/index.html

  37. Calli Arcale says:

    Bloodletting….

    I have a friend with a rare disorder that causes him to produce far too many red blood cells. He needs regular phlebotomy (bloodletting, basically) to keep things functioning normally. There is also a difficult-to-detect method of enhancing an athlete’s performance — you draw blood ahead of time, bank it, let the athlete train for a while, and then transfuse the blood back in right before the event. This gives them extra red blood cells, increasing their oxygen-carrying capability for a while. So there are definitely modern applications for the technique, besides drawing blood for the purpose of using or analyzing the blood.

    However, this is a far cry from what the term meant 200 years ago. As the esteemed Dr Hall correctly said, they weren’t bleeding people for any of the reasons mentioned above. They were doing it to balance the four vital humors, imbalances of which they believed were the source of all disease. The simplest method they had for adjusting the balance of humors was to remove blood; many diseases were held to be due to a surplus of blood. They were wrong, of course. There’s no reason to test that today; we know so much more than they did then that it’s easy for us to see just by looking at available data that it was an absurd concept. Testing it experimentally today would simply subject patients to significant harm for no good reason.

    I feel the same way about the chelation study. We know enough to know that there’s no reason it should work. The only reason to test it would be to satisfy a mild curiosity. That’s woefully inadequate justification. Children could die in this study. There has to be a better reason to not just rely on all the data already present about mercury and chelation.

  38. Hermano says:

    Calli,
    I just spent half-hour marveling at the Russian cosmonauts’ space walk on NASA TV. It’s awesome, thank you for letting me know about it.
    They still have 5 1/2 hours left to their walk, I wish them success and safe return.
    BTW, everyone sounded sober, this being an occasion when one should not drink.

  39. Calli Arcale says:

    Always glad to share a little space geekery. ;-) Hey, if you want more space geekery, come on over to http://www.space.com/common/community/forums/

  40. kim spencer says:

    “The purveyors of unscientific medicine want us to shut up because we are doing our best to expose the fact that they want to remove the scientific standard from medicine to help them line their pockets or promote their ideology.”
    EXACTLY, Mr. Novella!
    I just can’t stand it that you want me to shut up because vaccines containing toxins of unproven safety in unproven safe amounts (because proof would be “scientific standard,” right?) have been used on my child to line someone’s pocket, promoting someone’s ideology!

  41. Pingback: Viewsday
  42. Kim,

    No one told you to shut up. YOU questioned our right to express our opinions here (in our own forum).

    Vaccines have been scientifically tested and shown to be extremely safe and effective. You are spouting anti-vaccine propaganda.

    Toxins? Read this – http://www.sciencebasedmedicine.org/?p=9

  43. oderb says:

    I’m trying to more clearly understand the the level and nature of evidence to be employed in determining whether a substance or protocol is scientifically and ethically legitimate grounds for a RCT.

    Regarding autism I find a recent article by an M.D. who founded the Vitamin D Council that suggests – persuasively to me – that low levels of Vitamin D as a major cause of autism.

    I would appreciate if some of you would read his case and comment on whether it meets the threshold for testing.

    http://www.vitamindcouncil.org/health/autism/

  44. HCN says:

    oderb, what you posted was:

    Spam, spam, spam, spam… and more spam.

  45. Harriet Hall says:

    oderb,

    There is nothing in the medical literature about that hypothesis except for one article published in the journal “Medical Hypotheses.” Anything can be a hypothesis, and some really far-out fanciful ones make it into that journal. Without any real evidence, it amounts to nothing more than wild speculation and a kind of mental masturbation. I don’t think most knowledgeable scientists find this hypothesis as persuasive as you did.

    While vitamin D deficiency has been found in some autistics, that can probably be explained by dietary aberrations characteristic of autism and by a significant incidence of vitamin D deficiency in non-autistic children. The link cites a lot of suggestive correlations but correlation doesn’t prove causation. Lots of people are vitamin D deficient, and it’s not a bad idea to check autistic children for deficiency and correct it. A deficiency might even make some autistic symptoms worse. But that doesn’t mean a deficiency of vitamin D “causes” autism.

    How should we choose which suggested causes of autism to study? Just take a look at all the other hypotheses listed at http://en.wikipedia.org/wiki/Causes_of_autism#Vitamin_D

    There is actually some evidence (mostly poor quality) for some of these other hypotheses. The vitamin D hypothesis is simply dismissed as “has not been studied scientifically.”

    It would be reasonable to study whether correcting vitamin D and other nutritional deficiencies improved autistic symptoms, but I don’t think studying it as a “cause” of autism is a reasonable use of research money.

  46. oderb says:

    HCN,

    I thought that this is a site that examines scientifically based medicine. I posted an article from an M.D. who has been a key Vitamin D researcher and who makes the case – using an approach based on the scientific method – developing a hypothesis, discussing how the hypothesis is plausible and is consistent with the facts about Vitamin D and autism as we know them, cites numerous studies that provide some evidence to back up his assertions, and suggests that Vitamin D intake be increased while we wait for the proper RCT’s to be done on his hypothesis.

    HCN, Please be specific as to how my post is ‘spam, spam, spam’. Indicate how and in what manner Dr Connell misinterprets the science or research, or makes observations or conclusions that are patently false or highly questionable.

    If you cannot or choose not to I would ask that you withdraw your
    comment.

    Beverly, while I have found your previous posts and comments on my posts to be reasonable I was taken aback by your comment that the article is ‘wild speculation or a kind of mental masturbation.’

    I would ask you the same questions as i did HCN. What was contained in his highly referenced argument that fits the category of mental masturbation or wild speculation?

    And on what basis would you recommend that Vitamin D be studied to determine whether it would ameliorate symptoms but not be studied as to whether it is a causal factor in autism?

    Unless there is some glaring flaw in his arguments, or he has incorrectly cited the numerous research articles which back up his hypothesis, why shouldn’t his hypothesis be studied – particularly when the explosion of Vitamin D research in recent years suggests that is may well an effective disease preventative and treatment in many many bodily systems.

  47. oderb says:

    Sorry I meant to say Harriet, not Beverly, and excuse the mangled sentence at the end…….

  48. nitpicking says:

    I’d like to thank the anti-vaccine posters here, because their messages are indicative of the mindset involved.

    For instance, the idea that a neurologist who treats autistic people has “no stake” in curing autism shows the amazing conspiracy thinking of the whole CAM movement. They sincerely and reflexively believe that Dr. Novella, who has devoted much of his life to helping people with this syndrome, is somehow determined to prevent their cure.

  49. Harriet Hall says:

    oderb asks,

    “What was contained in his highly referenced argument that fits the category of mental masturbation or wild speculation?”

    The simple fact that he lists everything he can think of that might support his hypothesis without mentioning anything that might not. This kind of exercise is futile. It confuses correlation with causation and depends on confirmation bias. It reminds me of an exercise that was written up in Skeptical Inquirer where they compared two presidents and found so many points of comparison that it would have convinced gullible people that it “must” have been more than coincidence. Since the points of comparison were not pre-determined, it might be possible to find even more (different) points of comparison between any other 2 presidents.

    This is not an area that I am expert in, but I found at least one thing he seems to have gotten wrong. He says the difference in vitamin D metabolism with estrogen and testosterone might explain why more boys have autism, but this study found that “the marked increase in serum testosterone in male puberty has no significant influence on circulating vitamin D metabolite levels.” http://jcem.endojournals.org/cgi/content/abstract/62/3/503
    And at the age when autism is diagnosed, the level of these hormones is practically undetectable.

    The arguments on that website remind me of the arguments of the International Network of Cholesterol Skeptics, which I analyzed in another post. They gather a lot of facts and references but don’t put them into perspective, and they fail to look at facts that would refute their point of view. They have prematurely arrived at a conclusion and are trying to support that conclusion. That kind of exercise is not what inquiring scientists do.

  50. Fifi says:

    Certainly there’s been a lot of research into vitamin D, adults and adequate levels in Northern latitudes where people are prone to being deficient. It’s long been known that children need vitamin D for proper bone growth (it’s why kids used to be given cod liver oil as a means to prevent rickets), that’s why milk is fortified with vitamin D and we don’t see many cases of rickets anymore. Back to the research on adults – vitamin D seems to be preventative for prostate cancer but a trip to Florida for two weeks seems to offer exactly the same preventative effect. What this really means is that a vitamin D deficiency – not enough sunlight or vitamin D from food sources – contributes to the expression of cancer (not that it causes cancer).

    It vitamin deficiencies played into autism in any way, I’d suspect that it’s more likely to be in terms of a the mother. It’s well known that a deficiency in folic acid contributes to birth defects. This doesn’t mean that the birth defect can be “fixed” after birth using vitamins, it would have to be addressed during pregnancy.

    It seems that, shockingly, quite a few autistic parents just let their kids eat junk food. (Though I can understand being tired and just going for what’s easy, or just not understanding basic nutrition – which seems to be the case for quite a lot of America!) I’m sure the behavioral changes that occur once the children are put on healthy diets (rather than Pogos, soda and chips) seem miraculous to the parents of autistic children (and children with ADD). I know one mom who had noticeable results from doing so when she cut out sugar and started feeding her kids vegetables (her non-autistic kids’ behavior changed too). The reality is that any child who goes from eating a crappy diet (which, clearly, lots of children in the US do considering the rates of childhood obesity) to a healthy diet will start to behave differently because they’re not being subjected to sugar induced mood swings.

  51. Harriet Hall says:

    Oderb asks,

    “And on what basis would you recommend that Vitamin D be studied to determine whether it would ameliorate symptoms but not be studied as to whether it is a causal factor in autism?”

    On the basis that we know vitamin D deficiency causes some symptoms and that it’s probably a good idea to correct any nutrient deficiency.

    Oderb says vitamiin D “may well be an effective disease preventative and treatment in many many bodily systems.”

    That might only be true when it is used to correct a pre-existing deficiency. That means deficiencies should be identified and corrected. That doesn’t mean that vitamin D deficiency causes autism. It doesn’t mean that higher doses can be used to prevent or treat autism.

    When I said I don’t think studying it as a “cause” of autism is a reasonable use of research money, I meant in the context of all the other hypotheses for the cause of autism. Other areas have priority. Progress is being made in genetic studies. Once we know the genetic factors, we can start looking at how expression of those genes interacts with environmental and developmental factors. I didn’t mean it should “never” be studied, and we can keep this hypothesis in the back of our minds as we look at other information that might confirm or weaken it.

  52. AntiVax says:

    http://www.whale.to/vaccine/cave.html
    In a study last year, we found that about 40 percent of the children that we looked at (out of a total of perhaps 120) showed marked improvement, particularly in the younger age group. In most of the ones that resolve, the children go from not having any speech or eye contact to complete dialogue with good eye contact. It’s the two, three, and four year olds that resolve most quickly. Within about six to eight months time, they get to a point where you can’t tell that they were ever autistic. It’s amazing. The parents come into our office in tears; they’ll fly across the country just to show the children to us.

    Balancing Biochemistry: An Interview with Stephanie Cave

  53. HCN says:

    AntiVax = John Scudamore = whale.to

    In any discussion involving science or medicine, citing Whale.to as a credible source loses you the argument immediately …and gets you laughed out of the room.

    http://rationalwiki.com/wiki/Scopie%27s_Law

    Oderb, it is a common spam technique for someone to post “Hey, guys what do you think of this!”, and then post a website like you did with some kind “vitamindcouncil” name that implies it is trying to sell Vitamin D. Plus it has nothing to do with chelation. Therefore I assumed you were spamming.

    If you had gone to PubMed and posted one of the eight articles that appear with a search of “autism vitamin d”, then you might have something to start with.

    But since it is just eight papers, and two are from the same author, with one being in the “you pay us, we will print it” Medical Hypotheses journal — we would still not much interest to even bother with it.

    Especially with the most recent article on genetics, http://www.hhmi.org/news/walsh20080711.html , is much more interesting.

  54. Harriet Hall says:

    It took only a few years for the H.pylori hypothesis to be translated into standard medical practice. That didn’t appear in Medical Hypotheses but in mainstream peer-reviewed journals where it was accompanied by data.

    I’m curious. The journal “Medical Hypotheses” has been around since 1975. Does anyone know of any hypothesis that first appeared there, that was confirmed by medical research, and that has been accepted by mainstream medicine?

  55. overshoot says:

    I’m curious. The journal “Medical Hypotheses” has been around since 1975. Does anyone know of any hypothesis that first appeared there, that was confirmed by medical research, and that has been accepted by mainstream medicine?

    That’s an utterly fascinating question, Madame Doctor.

    I confess I haven’t a clue, but knowing the way things run online now leads me to suspect …

  56. AntiVax says:

    here is another site for your Scopie law logical fallacy http://educate-yourself.org

    EDTA chelation therapy has brought relief to more than 93% of patients suffering from ischemic heart disease and it can help avoid bypass surgery in 85% of cases.30 When it is given according to established protocols not one serious side effect has been reported. In fact, thousands of anecdotal stories from patients and physicians support the effectiveness and safety of this relatively inexpensive treatment.

  57. overshoot says:

    Fifi:

    It seems that, shockingly, quite a few autistic parents just let their kids eat junk food. (Though I can understand being tired and just going for what’s easy, or just not understanding basic nutrition – which seems to be the case for quite a lot of America!) I’m sure the behavioral changes that occur once the children are put on healthy diets (rather than Pogos, soda and chips) seem miraculous to the parents of autistic children (and children with ADD). I know one mom who had noticeable results from doing so when she cut out sugar and started feeding her kids vegetables (her non-autistic kids’ behavior changed too). The reality is that any child who goes from eating a crappy diet (which, clearly, lots of children in the US do considering the rates of childhood obesity) to a healthy diet will start to behave differently because they’re not being subjected to sugar induced mood swings.

    Among other things. One of the basic dicta WRT ADHD is that “anything that improves general health will improve ADHD.” Best-case is bad enough, after all. Add sleep deprivation (no, ADHD is not sleep deprivation), junk food (no, ADHD is not caused by junk food), lack of exercise (see above), etc. and you have a formula for disaster.

    It’s amazing the difference it can make, too — one of my ADHD kids finally got a clue (academic suspension can have that effect, I wish it were used more) and started keeping regular hours, eating real food, exercising, etc. and is now getting As in a tough physics program. No change in anything except coping behavior (and yes, it would have been much better had he learned those habits twenty years ago.)

  58. Fifi says:

    overshoot – Better late than never! Even someone without ADHD benefits from eating well, exercising and getting enough sleep. They’re just basic human biological maintenance!

  59. HCN says:

    John Scudamore said “here is another site for your Scopie law logical fallacy http://educate-yourself.org

    Yep, that is just as amusing as Whale.to… it even has a set of pages on “Planet X”! Where did “Planet X” go?

    But your mention of EDTA is not amusing:
    http://pediatrics.aappublications.org/cgi/content/full/118/2/e534

  60. HCN says:

    Antivax = John Scudamore = LIAR

    He lied “EDTA chelation therapy has brought relief to more than 93% of patients suffering from ischemic heart disease and it can help avoid bypass surgery in 85% of cases.30 When it is given according to established protocols not one serious side effect has been reported. In fact, thousands of anecdotal stories from patients and physicians support the effectiveness and safety of this relatively inexpensive treatment.”

    Wrong, wrong, wrongety wrong… From:
    http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=16262904

    “The findings of this systematic review should be of interest to clinicians and patients alike. The use of EDTA by patients as a treatment for cardiovascular disease and as an adjunct or alternative to surgery is not supported by the highest quality of evidence. Considering the cost incurred by patients who use EDTA chelation therapy and the potential for harm associated with any intravenous intervention including the potential for adverse effects attributable directly to EDTA, clinicians should inquire about patient use and highlight the lack of evidence to support its usage.”

  61. AntiVax says:

    Pot, kettle

    Science By Design http://www.whale.to/vaccines/ploy2.html

    Heart Surgery Does More Harm Than Good http://www.whale.to/a/whit.html

    “There are no scientific studies to indicate that this “invasive strategy” is best for patients, but that has not prevented the heart surgery industry from going ahead on the presumption that it is.”

  62. Calli Arcale says:

    “Heart Surgery Does More Harm Than Good http://www.whale.to/a/whit.html

    Are you seriously arguing that because heart surgery is used too much, we should use chelation where it’s not indicated?

    WTF???

    Are you saying that two wrongs make a right or something?

    (Oh, and you still don’t seem to have realized that quoting yourself is not particularly convincing. It’s like Richard Hoagland citing enterprisemission.com.)

  63. AntiVax says:

    After we implemented these therapies for one year, the state re-evaluated Evan for further services. They spent five minutes with Evan and said, “What happened? We’ve never seen a recovery like this.” http://edition.cnn.com/2008/US/04/02/mccarthy.autsimtreatment/index.html

  64. AntiVax says:

    Sums up your vax mercury is safe studies:

    “Any competent epidemiologist can employ particular tricks of the trade when certain results are desired” http://www.newsweek.com/id/135408

  65. HCN says:

    Antivax = John Scudamore = whale.to said (quoting Jenny McCarthy) “After we implemented these therapies for one year, the state re-evaluated Evan for further services. They spent five minutes with Evan and said, “What happened? We’ve never seen a recovery like this.” ”

    Then why is she considering chelating the poor child? See:
    http://leftbrainrightbrain.co.uk/?p=923

  66. David Gorski says:

    I love how John Scudamore counters the claims that Olmsted’s Amish report was a crock by citing…more Olmsted–only this time quoting a crunchy, antivaccination-friendly doctor’s self-admittedly “unscientific” observations.

    Can anyone say “confirmation bias”? Sure, I knew you could.

    Read Autism and the Amish for what Olmsted really did (or, more correctly, failed to do) when “investigating” his story. No wonder he no longer works for UPI.

  67. AntiVax says:

    “I’m still waiting for Mr. Olmsted’s side of the story. ” http://www.whale.to/vaccine/olmsted12.html

    He began calling in 2005 and received no response. In early 2006, he got through to Morton’s wife and CSC co-founder Carolyn Morton and was able to interview her briefly. And that was the last word Dan ever heard from anyone at the CSC. He made repeated attempts to follow up on this phone call, especially after an article published in the March 2006 edition of The New England Journal of Medicine (NEJM) provided data that the CSC had diagnosed autism spectrum disorders in six patients with a rare genetic disorder (see below). Dan has continued calling ever since, with the latest call coming as recently as the fall of 2007. He never received a return phone call.

  68. Calli Arcale says:

    Cool! AntiVax quoted a source other than himself!

    Of course, it was a couple of mass media articles rather than any actual, I dunno, *science*.

    I’m still trying to figure out what excessive use of heart surgery says about excessive use of chelation. I guess he’s trying to say that because doctors sometimes kill patients (according to his own website, natch), alties should be allowed to kill a few patients too.

    :-P

  69. overshoot says:

    He began calling in 2005 and received no response. In early 2006, he got through to Morton’s wife and CSC co-founder Carolyn Morton and was able to interview her briefly. And that was the last word Dan ever heard from anyone at the CSC. He made repeated attempts to follow up on this phone call, especially after an article published in the March 2006 edition of The New England Journal of Medicine (NEJM) provided data that the CSC had diagnosed autism spectrum disorders in six patients with a rare genetic disorder (see below). Dan has continued calling ever since, with the latest call coming as recently as the fall of 2007. He never received a return phone call.

    He might have better luck from a pay phone.

  70. yeahsurewhatever says:

    Sometimes it seems to me that the anti-vax parents (almost invariably mothers?) have cognitive problems just as severe as their children. Is that evidence that autism is hereditary? I’m only half-joking.

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