Saturday, March 04, 2006

Chelation therapy deaths: wrong drug or wrong indication?

I recently linked to an article in MMWR, a CDC sponsored periodical, about three chelation therapy deaths. Although other bloggers covered the issue thoroughly some months ago it resurfaced with the March 3 MMWR piece and the spate of media reports that followed. Reporting on the issue of chelation deaths was distorted from the beginning and the distortion persists in this latest barrage. A piece from the Pittsburg Post-Gazette characterized the death of 5 year old Abubakar Tariq Nadama as an example of medication error. CDC’s Dr. Mary Jean Brown is quoted "It's a case of look-alike/sound-alike medications." But this misses the larger point: chelation therapy was given to the child for the unproven and unapproved “indication” of autism.

The case has been well covered by other bloggers. Orac has blogged about it since August. I just found this insightful post by Dr. Kimball Atwood at Health Care Renewal who points out that Dr. Brown misses the real tragedy. It is not a simple case of medical error.

The January 18 Post-Gazette article quotes Dr. Brown as making the misleading statement “that it was medical error, and not the therapy itself” that caused the death. Worse, the article reports “Dr. Mary Jean Brown, chief of the Lead Poisoning Prevention Branch of the Atlanta-based Centers for Disease Control and Prevention, said yesterday that Abubakar Tariq Nadama died Aug. 23 in his Butler County doctor's office because he was given the wrong chelation agent.” Now I’m confused. That statement implies the existence of a “right” chelation agent. But can there be a right agent for a wrong indication? Although chelation therapy has seen an exponential rise in popularity as a treatment for autism there’s no scientific evidence that it works. According to this Quackwatch article, “The use of chelation therapy to treat autistic children is completely bogus.”

Maintaining that calcium EDTA is safer than disodium EDTA (used in the treatment of Abubakar Tariq Nadama) Brown “quoted from a 1985 CDC statement: Only Calcium Disodium EDTA should be used. Disodium EDTA should never be used ... because it may induce fatal hypocalcemia, low calcium and tetany."

That’s interesting, because as I pointed out (so did Atwood in the Health Care Renewal Blog) disodium EDTA, this dangerous drug which the CDC expert says should never be used, is exactly what is being used in the NCCAM sponsored Trial to Assess Chelation Therapy (TACT). Maybe the NCCAM should have checked with the CDC before launching the study. As I understand it TACT is to be the definitive study to determine whether chelation therapy is ready for prime time in the treatment of cardiovascular disease. But aren’t there safety standards that must be followed in such trials? One of the purposes of phase 1 and 2 studies in mainstream drug development, as I understand it, is to help establish conditions for optimal drug safety in phase 3 studies and beyond. Well, this isn’t mainstream drug development.

But I digress. Another chelation related death mentioned in the MMWR article involved a 53 year old woman being treated in a naturopathic practitioner’s office. In my previous post I didn’t comment on the appropriateness of the treatment because the indication wasn’t given. However, I subsequently found this report which states the treatment was given for “clogged arteries.” The type of chelation solution she received is apparently not known. The media seem most interested in finding out what type of preparation was used, downplaying the more important issue of pseudoscience.

The CDC and its media accomplices have wrongly spun these cases as examples of medication mix ups. In fact only one of the three deaths profiled in the MMWR report, the case of a child being chelated for lead poisoning, was attributable to medication error. The best information we have indicates that the other two patients were being treated for purported indications not scientifically validated. In the absence of any scientific indication for the modality in question there’s little point in talking about the right versus the wrong drug. There’s no right drug for a wrong indication.

3 comments:

Anonymous said...

Your statement: " But this misses the larger point: chelation therapy was given to the child for the unproven and unapproved ‘indication’ of autism."

Your assumption is wrong. The “indication” for use of chelation of heavy metals in children is that they have heavy metal toxicity. The children also happen to have been labeled with the diagnostic term “autism” but this label has no physiological meaning or significance. No responsible physician, and there are many, who use chelation with heavy metals for children with heavy metal toxicity, will use chelation without substantial blood work and urine analysis to determine if the biomarkers of heavy metal toxicity are present. Chelation with CaEDTA is used in children only for heavy metal toxicity. It is your incorrect assumptive opinion that it is being used to treat "autism."

The MMWR was accurate and helpful. Endrate or disodium EDTA is used by some practitioners to pull calcium from adult heart patients. This form of chelation is completely unrelated to the chelation used to pull metals from children with heavy metal toxicity.

The tragedy of the case of the five year old boy near Pittsburgh is that a mistake was made and the wrong drug was used. Many physicians used that opportunity to criticize chelation in general without knowing that the wrong drug was used.

Like all therapies and drugs chelation carries side effects and risks. That is why responsible practitioners carefully monitor children undergoing chelation for liver toxicity, mineral depletion and other side effects. That is the responsible medical approach when using chelation for heavy metal toxicity in children.

May I ask why you set up a straw man that you can knock down by claiming that chelation is used to treat “autism”. Your assumption that chelation is being used to treat “autism” is simply incorrect. No one knows what “autism” is – it is a diagnosis based on a checklist established by the APA based on observed behaviors and has no relevance to physiological conditions, except to point to the fact that something is physiologically wrong with a sick child.

Rather than condemn those who use chelation for children who are seriously ill, perhaps we should all pressure the government to conduct proper studies of the prevalence of heavy metal toxicity in children today and the use of chelation to remedy that condition and its related symptoms.

R.J. Krakow, Parent

R. W. Donnell said...

Anonymous,
The newspaper article to which I linked in my post said the chelation was being given to treat autism. If provided with evidence that that is not true I'll revise my statement, and so should the Pittsburg Post-Gazette.

I agree with you that the only indication for chelation therapy is the treatment of heavy metal toxicity. I also agree that no responsible physician would offer such therapy without careful documentation of the biomarkers of heavy metal toxicity.

It is not my assumptive opinion that chelation is being used to *treat* autism. Indeed I don't believe chelation can treat autism at all. But I do have reason to believe chelation is being *promoted* by many (not the responsible physicians to whom you refer) as a treatment for autism.

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