Justice for Abubakar Tariq Nadama at last?

A little more than a year ago, an autistic boy named Abubakar Tariq Nadama died of a cardiac arrest due to hypocalcemia at the hands of an “alternative medicine” practitioner named Dr. Roy Kerry while chelation therapy was being administered to him intravenously. Dr. Kerry, who trained as an ENT doctor, now bills himself as an “allergist” and an alternative medicine practitioner. Tariq’s tragic and unnecessary death lead to a round of posterior covering by mercury militia enabler David Kirby and a rather blithe acceptance and dismissal by some who routinely go ballistic whenever someone undergoing conventional treatments dies as a result of that treatment.

Finally, it now appears that justice, long delayed, is finally coming for Dr. Kerry:

PITTSBURGH (AP) — State officials have filed disciplinary charges against a doctor who prescribed a therapy for people with lead poisoning to a 5-year-old autistic boy who had a heart attack and died.

Dr. Roy E. Kerry, 68, of Greenville, was charged Sept. 8 with six counts that include engaging in unprofessional conduct and breaching the standard of care. Abubakar Tariq Nadama died in August 2005 following his third chelation treatment at Kerry’s clinic, the Advanced Integrative Medicine Center in Portersville, about 25 miles northwest of Pittsburgh.

This is good, but it still irritates the heck out of me to see the nature of the charges. Like the CDC‘s emphasizing the use of the “wrong” chelation agent (there is no “right” chelation agent for autism, because chelation therapy doesn’t do anything for autism, because, as more and more evidence shows, there is no good epidemiological or scientific evidence that autism is caused by “mercury poisoning”), the State of Pennsylvania makes the same mistake:

The Department of State alleges, among other things, that Kerry prescribed an IV push — meaning the drugs are administered in one dose intravenously — despite warnings that this method can be lethal. He also prescribed the wrong formula of the drug, officials said.

No, no, no. The use of chelation therapy to “treat” autism that leads to serious complications should be sufficient cause in and of itself for action. The formulation used isn’t the issue (although certainly Kerry was reckless and incompetent in choosing disodium EDTA). The use of a non-evidence-based, ineffective, and potentially dangerous treatment is. Couple that with Dr. Kerry’s apparent cluelessness in giving the “wrong” chelation agent and you have a recipe for disaster. It’s hard not to conclude either that Dr. Kerry is a quack using potentially dangerous and unproven treatments for autism or that he’s an incompetent doctor who, in trying to use a relatively safe but unproven and almost certainly ineffective treatment for autism, screwed it up and used the wrong chelator, leading to the death of a child. Either way, it astounds me that this guy has kept his medical license thus far, and that it’s taken 14 months for the state to bring disciplinary charges against him.

And what are the potential penalties for Dr. Kerry? Far too lenient, I’m afraid:

If the State Board of Medicine finds any of the charges to be true, Kerry could have his medical license revoked, suspended or restricted and could pay up to $10,000 in fines for each violation.

A maximum of $60,000 fines and revocation of his medical license for the death of a child due to blatant quackery? Does that sound proportionate to the offense to you? And Kerry has even been allowed to continue practicing for 14 months plus however long the legal proceedings take from this point forward. One can only hope that Tariq’s parents sue for malpractice, as they would very likely win. One phrase in this article in particular leapt out at me, though:

Some people believe autism can be linked to a mercury-containing preservative once commonly used in childhood vaccines. Chelation therapy has been advocated as a remedy.

“Some people believe”? That about sums up the entirety of the evidence supporting the concept that chelation therapy can do anything to help children with autism. Unfortunately, in this world where evidence doesn’t matter and alternative medical therapies do not even have to show biological plausibility to attract research funding, particularly from the National Center for Complementary and Alternative Medicine (NCCAM), even a therapy with so little evidence to suggest even a hint of efficacy can attract funding. Yes, I’m talking about chelation therapy for autism, for which a new clinical trial has been opened. Surprisingly (and disappointingly), the study is not being sponsored by NCCAM, as would be expected. Instead, it’s being run by the National Institute of Mental Health (NIMH):

Chelation of metals is widely used in the community to treat individuals with Autism Spectrum Disorder (ASD), with some surveys estimating that 1 in 12 children with autism have undergone chelation. This widespread use reflects the hypothesis that many cases of ASD are caused by exposure to thimerosal, an ethylmercury-based compound used previously in the US as a vaccine preservative for routine childhood immunizations. The prevalent use of chelation therapy stands in stark contrast with the lack of scientific or clinical evidence of efficacy, and creates a public health imperative for empiric data. Thus we propose a controlled trial of the effects of chelation on the core behavioral symptoms and overall functioning of children with ASD. The present investigation is a double-blind, randomized placebo-controlled study of the oral chelating agent meso-2,3-dimercaptosuccinic acid (DMSA; succimer) among 120 children, ages four to ten years, who meet criteria for ASD. Pre- and post-treatment behavioral ratings will be used to evaluate the efficacy of chelation. In addition, children will undergo comprehensive medical history, physical examination and laboratory analyses.

Our objective is to quantify differences in behavioral functioning between the chelation treatment group and the placebo control group. Analysis of mercury levels before and during the course of treatment will be used to confirm the expected DMSA-induced excretion of mercury and to identify differences among children in the extent of excretion. Our primary hypothesis is that, on average and relative to the control group, children with ASD who undergo chelation with DMSA will show greater improvements in communication and social behavior.

It makes me wonder if reforming NCCAM (or even the more radical step of dismantling NCCAM and folding its research activities into the relevant NIH institutes) would have any effect at all on the funding of studies of alternative medicine therapies based on unsupported hypotheses. The concept that a therapy need not have biological plausibility or compelling preclinical evidence to suggest efficacy to be eligible to be studied in a large clinical trial seems to have metastasized beyond NCCAM into other NIH institutes.

I’ll sum up the rationale of this trial very succinctly. It’s very much like the statement in the article about Tariq Nadama above and goes something like this: “Some” people believe that mercury in vaccines causes autism, despite the lack of clinical, basic science, or epidemiological evidence to support the hypothesis that it does and the fact that each successive study over the last couple of years has failed to find a link (“the prevalent use of chelation therapy stands in stark contrast with the lack of scientific or clinical evidence of efficacy”). These people are a pain in our rears and believe in this treatment with an almost religious fervor. So we should waste all sorts of money doing a clinical trial in the hopes of showing that the proposed therapy works no better than placebo, and maybe that will get these people to leave us alone.

Yes, I think I’ve probably paraphrased the rationale pretty accurately. Unfortunately, it seems to be the rationale for a lot of trials in alternative medicine these days.

Normally, I would almost sympathize with such a viewpoint and would support such a trial just to provide objective evidence. Indeed, the basic randomized design of the trial seems sound enough to test the hypothesis that chelation positively impacts behavioral parameters in autism.The problem is the premise more than the design. The hypothesis itself is what’s dubious and unsupported by existing evidence. Worse, this trial strikes me as unethical. Chelation therapy is a treatment for mercury poisoning, and there is no evidence that mercury levels are elevated in autistic children. Indeed, there is evidence that blood and hair levels of mercury are no different in children with autism or autistic spectrum disorder than they are in children without such a diagnosis. In addition, one of the inclusion criteria (detectable blood mercury level greater than 0.1 mcg/dl) overlaps so much with the reference level for mercury of 1 mcg/dl in unaffected children that it is clear that the vast majority of the study subjects will have in essence normal mercury levels. Indeed, children with grossly elevated mercury levels are explicitly excluded from the study, presumably because they clearly need treatment and randomizing any of them to a placebo group would be unethical. Another problem with the study that practically leaps out of the text is that it excludes patients who have had previous chelation therapy. While this is a reasonable, indeed almost mandatory, exclusion criterion on a strictly scientific basis, in the real world the very parents attracted to this study will be ones who have already chelated their children. These parents are unlikely to have any interest in taking a chance of being in the placebo group and thus are unlikely to sign up. Other parents who aren’t true believers will be a lot less likely to want to expose their children to treatment that is so implausible and that has so little evidence to suggest efficacy–that is, unless the NIMH pushes the study.

Mike Stanton summed it up well:

Note that autistic children with heavy metal poisoning are not eligible for this study. They need treatment and it would be unthinkable to put them on a placebo. But this means that to be eligible for a study in which you may be treated for heavy metal poisoning you must be completely healthy and not have heavy metal poisoning.

Autistic children with traces of heavy metals in their blood that are no different from the levels in NT children are going to be subject to unnecessary medical treatment to see if it alters their behaviour. Well, it would certainly alter mine!

I wonder why they are only recruiting autistic children? Perhaps NT children with the same reference levels of mercury would also benefit from a dose of chelation therapy. But what self respecting parent of a healthy child would submit their child to that? And that goes for the parents of healthy autistic children as well.

Indeed. It almost makes me think that I spoke too soon when I lamented about institutional review boards’ (IRBs) overreach that results in their frequent tendency to make research with a low risk of harm to patients too burdensome. This NIMH trial is an example where the IRB apparently didn’t go far enough, didn’t ask the hard questions, and didn’t put the researchers on the spot as they should have. After all, the examples that I gave of IRB excesses were for studies that did not involve giving an actual drug to patients; they merely involved questionnaires and interview studies. The NIMH study involves giving a drug designed to lower mercury levels to children, most of whom by definition in the inclusion criteria, will not have evidence of elevated mercury levels and indeed explicitly excludes children who do! (On the other hand, I suppose, I could choose to look at this travesty of a trial as evidence that supports my point that all this increasing aggressiveness by IRBs do not necessarily protect patient safety.) In any case, I can’t believe this study in its current form through a well-functioning IRB. Certainly, it never would have passed muster at our IRB, nor would a second NIMH study being started that will subject some autistic children to invasive procedures like lumbar punctures for unclear reasons.

I think Mike Stanton described the strange ethics of this study quite well:

There is a final ethical consideration I would like to raise.

Parents approach DAN! practitioners with a false belief about their child’s health, seeking treatment for that child. The DAN! practitioner shares their belief and provides the treatment.

Parents approach a NIMH doctor with a false belief about their child’s health, seeking treatment for that child. The NIMH doctor does not share their belief. In fact they have to establish that the child is not ill. But they still provide the treatment requested by the parent.

Who has made a moral decision here; the DAN! practitioner or the NIMH doctor?

You could almost ask the same question, inserting the name of Dr. Roy Kerry in the place of the DAN! practitioner. In fact, there’s almost no need to make such a substitution; Dr. Kerry is a DAN! practitioner. I’ll even go one step further. I’ll give Dr. Kerry the benefit of the doubt and assume that he is a True Believer, that he honestly thought he was doing Tariq good, and that he was sincere. I’ll assume that his motives were good, but that he probably didn’t know better.

NIMH, on the other hand, should know better than to set up a trial based on a dubious hypothesis backed by no convincing basic scientific or clinical evidence that would justify a trial of this magnitude. More’s the pity.