Jan 07 2010

Chelation Fraud

Chelation therapy is a legitimate FDA approved therapy for heavy metal poisoning. It uses either oral or intravenous drugs (EDTA – Ethylene-diamine-tetra-acetate) that bind to heavy metals and make them easier to excrete. The treatment is FDA approved for lead poisoning, hypercalcemia, and digitalis toxicity.

However, as discussed in a recent Forbes article, chelation therapy also leads a double life, and at the fringes of established medicine it has been used off label for decades to treat a long list of diseases and disorders. The first target of fringe chelation therapists, such as Dr. H. Ray Evers who was an early proponent, was cardiovascular disease. Dr. Evers won a court ruling in 1978 validating his right as a physician to prescribe off-label medication. However, of interest Dr. Evers in 1986 had his license to practice medicine revoked for gross malpractice.

The claim for chelation and heart disease is that heavy metals cause the build up of plaque on artery walls, and this plaque can be melted away by leaching off those metals with chelation. “Bypass bypass” has been the slogan of proponents of this idea. It would certainly be nice if physicians could perform a lucrative procedure in their office and improve their patient’s health, and even avoid risky and more expensive interventions. Medical doctors (if not heart surgeons) have every incentive to accept and promote the claims of the chelation therapists – except that it doesn’t work.

What we have is a situation in which a small minority of physicians are promoting a therapy for decades without doing proper trials to demonstrate that it is effective for the indications for which they are using it (such as cardiovascular disease). Small preliminary studies show mixed results, and the well-designed studies are negative. Meanwhile, our basic science understanding of cardiovascular disease goes against the presumed mechanisms of benefit from chelation in heart disease. The science, in other words, relentlessly moves against the claims of chelation therapists.

So, having lost the science, they resort to political means to defend and promote their treatment. They formed the American College for Advancement in Medicine – which is really for the advancement of the unscientific uses of chelation. They fight for the right to practice unscientific medicine, and unfortunately they have been successful enough to keep practicing. They call for more research, as if they will change their practice based upon more research, when they haven’t despite decades of science going against them.

In fact, at this point further research into chelation for cardiovascular disease would be unethical, in my opinion and that of many others. That has not stopped the NIH from conducting just such a study (the TACT study) – a decision that was very controversial. We will see what happens when the study is complete. If the study shows a beneficial effect, that would certainly be a surprise and would force a rethinking of the potential for chelation therapy – although by itself would not wipe away all the existing evidence that chelation does not work. It would upgrade the issue to truly controversial, and then more research would be needed to settle the debate.

If it is negative, given the low plausibility and existing negative evidence, that should be the final nail in the coffin of chelation for cardiovascular disease. Practitioners should accept the results (as some promise) and abandon their claims and practice for chelation and cardiovascular disease. Critics predict that this will not happen, however. Believers will find some excuse to dismiss the results – once you abandon science-based medicine, and embrace the dark side of pseudoscience, forever will it control your destiny.

In fact, chelation proponents have been expanding the list of diseases they believe chelation can treat – a common trend. Again – once you abandon a reasonable scientific approach to medicine, you can subjectively validate any claim, and so there is a clear phenomenon of “indication creep” for scientifically dubious treatments. Further, indication creep equates to an expanding market.

The most significant addition to the chelation therapy claim is autism. Alternative practitioners, based upon the failed hypothesis that autism is linked to mercury toxicity, in vaccines or in the environment, have chelated thousands of autistic children. There is no plausibility and no credible evidence to support its use. The NIH has also considered doing a large trial of chelation in autism, but this study was canceled due to criticism. The difference between the cardiovascular study and the autism study, which were equally criticized, is that the autism study would have involved children who cannot consent for themselves. That seemed to tip the balance against the study.

Anti-vaccine alternative practitioners have also expanded the use of chelation therapy for any and all perceived “vaccine injuries”. The most famous such case is that of Desiree Jennings, who was treated by Dr. Buttar for her “dystonia” which he claimed was an acute mercury toxicity from the flu vaccine. The rapidity of her response only served to reinforce the clinical impression that her symptoms were psychogenic, and not due to any neurotoxicity.

Conclusion

The history of the misuse of chelation therapy reflects the broader issue of science in medicine. If you believe that the best science should be used to determine which therapies are safe and effective for which conditions, and that health care providers should be held to at least a minimal standard of care, then you should also be outraged by the story of chelation therapy. It represents a complete failure to protect the public from useless therapies and for the various mechanisms of regulation to provide for a minimal safety net of science-based practice.

What the history tells us is that it is too easy for dedicated proponents to exploit the weaknesses in the system to practice grossly unscientific medicine out in the open.

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