Another perspective on Abubakar Tariq Nadama

Recently, I took Dr. Mary Jean Brown, Chief of the Lead Poisoning Prevention Branch of the Centers for Disease Control to task for some ill-considered and ill-advised comments about the death by chelation therapy of a five year old autistic boy named Abubakar Tariq Nadama in August. I wasn't the only health care professional who thought her remarks to be pretty off base. Indeed, Dr. Kimball Atwood also thought her remarks were pretty poorly considered:

Roy Poses was absolutely correct that Dr. Mary Jean Brown, the CDC’s “expert in chelation therapy,” missed the real point of the tragedy: that the child was a victim of quackery, not merely of “medical error.” The truth is even more disturbing than that, however. Dr. Brown may have been technically correct that if calcium-disodium EDTA had been used instead of disodium EDTA, the child would likely not have died of hypocalcemia (though he might have died of another complication; calcium-disodium EDTA is also a dangerous drug). But this was not a simple case of mistaken drug identity, or "look-alike/sound-alike medications," as Dr. Brown supposed. Disodium EDTA is the form of EDTA preferred by the major advocacy group for all implausible uses of "chelation therapy," the American College for Advancement in Medicine (ACAM)*—the same organization that the FTC had cited in 1998 for “false or misleading” claims regarding “chelation therapy” and atherosclerosis.

The reason for that preference seems to be that when EDTA was first being pushed as a miracle cure for atherosclerosis (‘60s-‘70s), its purported mechanism was to leach calcium from plaques. That claim, which can still be found in pro-chelation literature, has largely given way to the theory that chelation works as an anti-oxidant by removing heavy metals such as mercury, lead, copper, and iron. Both of these theories are implausible on stoichiometric and physiological grounds. The disodium form of EDTA persists as the ACAM-recommended preparation, not only for atherosclerosis but for arthritis, Alzheimer’s, Parkinson’s, psoriasis, high blood pressure, scleroderma, cancer, macular degeneration, and more. The rationale for “chelation therapy” in autism, according to advocates, is that the disease is caused by mercury poisoning—mainly from childhood immunizations. This claim is not supported by epidemiologic studies.

More damning, he points out the NIH-funded trial looking at chelation as a "therapy" for atherosclerotic disease and sees Dr. Brown's remarks as an unintentional indictment of the NIH for funding that trial:

The NIH language implies that disodium EDTA for any other purpose is merely “off-label” and is safe, which is what chelationists and their influential champions assert (see p.2 of this slow-loading document). But this is misleading, because the FDA has specifically contraindicated disodium EDTA for atherosclerosis, and a “black box” warning states: “The use of this drug in any particular patient is recommended only when the severity of the clinical condition justifies the aggressive measure associated with this type of therapy.” Thus the numerous unapproved uses of disodium EDTA, prescribed by that strange subculture of practitioners who preach “detoxification” as a near-panacea, do not meet FDA standards for off-label use. On p. 37 of the TACT protocol, version 2, NIH investigators refer to such practitioners as “prominent experts.”

Perhaps unbeknownst to Dr. Brown, her statements would seem to challenge the NIH to explain why it would expose human subjects to a drug that the CDC considers highly dangerous, when a less dangerous substitute is readily available. The larger question is why the NIH would expose 2300 human subjects in a Phase III study of a treatment that has yet to successfully graduate from Phases I or II, and that has not been substantially studied in animals. Federal Code states: “Phase III studies…are performed after preliminary evidence suggesting effectiveness of the drug has been obtained…” The Declaration of Helsinki states: “Medical research involving human subjects must…be based on a thorough knowledge of the scientific literature…and on adequate laboratory and, where appropriate, animal experimentation.”

Indeed. It has never ceased to amaze me that a therapy like chelation therapy for cardiovascular disease, a disease for which there is no evidence that it works and plenty of evidence to suggest that it is no better than placebo, has graduated to a major NIH-funded Phase III study without having passed through the usual hurdles required of new therapies, namely evidence of effectiveness in animal models and then Phase I and/or Phase II studies. Alties frequently complain that "conventional medicine" doesn't give them a chance, doesn't let them prove themselves on a level playing field. It's true that alternative medicine doesn't compete on a level playing field with conventional medicine, but not in the way alties think. In actuality, alternative medicine is held to much lower standards than conventional medicine. In fact, the chelation therapy trial described above is perhaps the best example of giving alties a pass on the usual standards of evidence before funding a major Phase III trial. It is in essence affirmative action for "alternative medicine" and quackery. No drug developed by big pharma, not even Vioxx, got that big a pass. If I were to submit a grant application to fund a trial to test the efficacy of a conventional medication based on evidence as thin as the evidence that got this trial funded and the even thinner evidence that got the trial for the Gonzalez therapy for pancreatic cancer funded, I'd be laughed out of the study section and my application filed in the circular file.

Dr. Poses of the same blog also has a take on this issue that I should have thought of before, namely how a CAM misadventure with a therapy that was being used for a disease for which it should never have been used is attributed to a "drug mixup," just as if it were a medical error:

Chelation therapy for conditions other than lead poisoning has been advocated widely in the complementary and alternative medicine (CAM) community, as per this post in Quackwatch. It is easy to find CAM web-sites that tout chelation therapy for autism, e.g., here and here. There is no good evidence from clinical research to support the use of chelation with calcium disodium EDTA for autism. Substituting a similar, but more dangerous medication for an anecdote-based CAM treatment was not a medical error, because it did not occur in the course of conventional medical treatment. So perhaps it should have been called a "CAM error."

Physicians who attempt to base their practice on science have already been saddled with the responsibility for innumerable medical errors. They do not deserve to also be made responsible for the misadventures of alternative practitioners.

I wish I'd said that.

Even if Dr. Roy Kerry, the quack who killed Abubakar, did mix up the medications, the bottom line is that attributing Abubakar's death to a "medication error" partially lets Dr. Kerry off the hook. It implies that, if he had simply not screwed up the medication (a contention that is not at all clear or proven) that it would then have been acceptable for him to use a potentially lethal medication for a condition for which there is no credible scientific or clinical evidence that this medication does any good. It wouldn't have been acceptable, and it wasn't. Dr. Brown's remarks in essence excuse Dr. Kerry's quackery.