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Sometimes science and ethics win out

Yesterday was a good day.It was a good day because it was one of the days that shows that, sometimes, science and ethics do win out after all:

CHICAGO (AP) — A government agency has dropped plans for a study of a controversial treatment for autism that critics had called an unethical experiment on children.

The National Institute of Mental Health said in a statement Wednesday that the study of the treatment — called chelation — has been abandoned. The agency decided the money would be better used testing other potential therapies for autism and related disorders, the statement said.

The study had been on hold because of safety concerns after another study published last year linked a drug used in the treatment to lasting brain problems in rats.Chelation (kee-LAY’-shun) removes heavy metals from the body and is used to treat lead poisoning. Its use as an autism treatment is based on the fringe theory that mercury in vaccines triggers autism — a theory never proved and rejected by mainstream science. Mercury hasn’t been in childhood vaccines since 2001, except for certain flu shots.

But many parents of autistic children are believers in the treatment, and NIMH agreed to test it.The researchers had proposed recruiting 120 autistic children ages 4 to 10 and giving half a chelation drug and the other half a dummy pill. The 12-week test would measure before-and-after blood mercury levels and autism symptoms.The study outline said that failing to find a difference between the two groups would counteract “anecdotal reports and widespread belief” that chelation works.

Except that it wouldn’t have.

Antivaccinationists would never have believed this study if it were negative, and because there was no plausible biological mechanism for chelation therapy to dhave a therapeutic effect , the the chances that any child would benefit were slim and none while the chances of a child being injured were not inconsequential. Steve Novella has already written a post discussing in detail why the proposed study represented both bad science and bad ethics.

Overall, it was an excellent decision to kill this misbegotten and ill-conceived study. Just because a lot of dubious practitioners have profited off of the belief of a vocal minority of parents of autistic children that chelation therapy does anything to improve autistic symptoms is not in and of itself adequate justification to do a clinical trial. Certainly it’s no reason to bypass the usual series of studies necessary to justify and lead up to a clinical trial, including basic science, cell culture models, and animal models, required to provide scientific justification before testing a therapy in humans. Remember, autism is a condition of developmental delay, not developmental stasis. There are not uncommonly periods of little progress followed by periods of rapid progress, and there is a significant fraction of children who “recover,” at least to the point of being able to live independently, even in cases of initially severe-appearing autism. It’s very easy to confuse correlation of improvement with the initiation of some new “treatment” or other with that treatment causing the improvement.Besides, once again, no matter what the results of the study, the true believers wouldn’t believe it anyway. In fact, they’d declare it a conspiracy, just as the antivaccinationists at Age of Autism will no doubt soon be calling it. Indeed, they already have:

So who canned the NIMH chelation study as “too dangerous?” Children are given huge doses of chemotherapy and radiation in a desperate effort to save them from cancer – fully knowing the side effects themselves can be deadly. It’s a fair risk most parents are willing to take to help a sick child.

It’s a silly analogy, because we have science and clinical trials to show that chemotherapy and radiation therapy can result in an 80% or higher survival rate in childhood cancers that, untreated, result in virtually 100% mortality. In the case of chelation therapy we don’t even have a plausible biochemical or physiological mechanism by which it might work, much less all the preclinical and clinical data. Not surprisingly, the conspiracy theories are flying fast and furious, as a commenter named Craig Willoughby furiously states:

So, why do I sense Pauly PrOffit’s grubby, greedy little fingers on this? This smells like something that he would do, and we all know how he hates those “evil” little DAN Doctors for curing those kids that he has worked so hard to poison.

Mr. Willoughby is referring to Dr. Paul Offit, a prominent vaccine scientist and defender, and to the antivaccinationists the Dark Lord of Vaccination. To many antivaccine activists, Dr. Offit is Satan Incarnate because of his vociferous defense of the vaccine program and because he has in the past partnered with big pharma to bring new vaccines to the marketplace.

We should be happy today, though. Sometimes science wins out, and yesterday was just such a day when that happened. Autistic children will not be subjected to risk with almost certainly no potential for benefit, and the money that would have funded this study can be spent elsewhere. If the advocates of chelation can come up with better evidence to support such a study, such as basic science and animal models, then it would certainly be reasonable to reconsider this decision. But until then, with what we know with a high degree of certainty now this trial was all risk and no benefit.

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

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2 thoughts on “Sometimes science and ethics win out

  1. Jules says:

    Please please please tell me that the summary of the NIMH study was a joke.

    What in hell did the study intend to find? Did they seriously think…?

    Never mind, don’t answer that…I’ll just crawl into a hole with a toilet brush and scrub out my brain.

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