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Chelation: Compounding Pharmacy’s Problems

Chelation is the provision of a substance to increase the body’s excretion of heavy metals. In poisoning situations (lead, aluminum, iron, etc.), chelation is medically necessary, objectively effective, and approved for use. But the same term has a completely different meaning in the alternative medicine universe, where proponents often believe heavy metal toxicity is the “one true cause” of disease, and chelation can undo microvascular inflammation, atherosclerosis, and even aging itself. From early days as an unproven treatment of coronary artery disease, its use has expanded to include autism, Alzheimer’s disease, cancer, and dozens of other diseases. Today, chelation is widely available. Regrettably, my own profession, pharmacy,  facilitates this pseudoscience by manufacturing and selling chelation products.

Provoked urine tests are a common entry point to chelation therapy. Patients are given a product to provoke heavy metal excretion. The urine is tested and the patient is informed that they’re “toxic” and require chelation. Unfortunately, these results are meaningless and provide no evidence that chelation is medically necessary. But that’s the justification used for advocating a treatment regimen that will be useless at best and fatal at worst. A recent Medical Letter review concluded:

Medical Letter consultants believe that the use of chelation therapy in non-standard protocols for unsubstantiated indications should be discouraged. The results of provoked urine testing are not an acceptable basis for such treatment.

Providing chelation to patients isn’t a straightforward matter. It’s typically an intravenous infusion (though there are some oral products). Unless you’re part of the dubious TACT trial, which has administration centres across the United States and Canada, there are few products commercially available. For example, edetate calcium disodium (EDTA) is approved for sale in the United States but not Canada. Edetate disodium (also called EDTA) is not approved for sale in either country. But these products are widely available: they’re manufactured by pharmacists in pharmacies.

Not that many decades ago, almost all prescriptions were custom manufactured, or compounded. The pharmacist combined raw chemicals into dosage forms like capsules, tablets, liquids and creams. Compounding allows complete customization of a prescription — from a new strength of a capsule, to a liquid form of a tablet, to creams with combinations of ingredients that can be completely individualized. With the proper equipment, even sterile injectables can be made.

These days, commercial manufacturers supply most drug products, and the need for in-pharmacy compounding has dwindled. At the same time, regulatory oversight, by agencies like Health Canada and the FDA, ensure product uniformity, purity, potency, efficacy, and safety standards for consumers. However, any pharmacy is still capable of providing compounded prescriptions, and some specialize, calling themselves “compounding pharmacies” and aggressively promoting the service. In compounding pharmacies, the same level of regulatory oversight and scrutiny does not exist. Professional Compounding Centers of America, provides training, formulations (recipes), and raw ingredients to compounding pharmacies. To pharmacies and pharmacists, compounding is a business opportunity, and an ideal way for independent pharmacies to compete against large chain stores, which typically do not offer these services.

The relationship between compounding pharmacies that prepare chelation treatments, and the practitioners that prescribe these products, is a symbiotic one — each group needs the other to offer these treatments. Consider this article in a pharmacy publication, entitled, Chelation for Antiaging: The Pharmacist’s Role, which touts the benefits of chelation:

Removing toxic metals from the body is one of the most important antiaging therapies available. The results from many scientific studies indicate that an increased accumulation (body burden) of toxic metals—such as mercury, lead, cadmium, and arsenic—increases the risk for common diseases, including cancer, cardiovascular disease, diabetes, Alzheimer’s disease, and attention-deficit/ hyperactivity disorder.

And:

Serious toxic-metal problems must be managed by an experienced physician. It is becoming increasingly recognized, however, that virtually everyone has a chronic accumulation of toxic metals in the body, which contributes to health problems and accelerates the aging process. Pharmacists who take the time to become knowledgeable about the correct use of OTC detoxification products can provide a much-needed service. At the same time, guiding customers on detoxification protocols also can become a new source of income for pharmacists who charge for their consultation time.

It’s a huge, burgeoning, evidence-free marketplace that pharmacies have stepped in to fill. College Pharmacy in Colorado has a “Hot List” of chelation protocols including the DAN! protocol — all of which can be ordered. Dallas-based ApothéCure offers a huge list of intravenous chelation options. Quantum Pharmacy in San Francisco touts a long list of benefits from EDTA infusions. Smith’s Pharmacy in Toronto offers chelation among a number of biomedical treatments for autism.

If there’s no evidence to support its use, why the persistent interest in chelation? Despite anecdotal evidence of success, my sense is chelation is simply another manifestation of sympathetic magic: specifically, contagious magic. Patients remove these non-existent “toxins” and become “cleansed” through a sciencey-looking purification ritual that is repeated dozens of times. With no objective measurement of efficacy, protocols and treatment measurements vary widely, but typically lack a defined endpoint. According to the Medical Letter, regimens of 20-50 infusions are common, at costs of $100-$300 per treatment.

Regulators have had difficulty finding a balance between allowing the legitimate practice of individualized compounding of products to meet unique patient needs, and the desire to limit pharmacy compounding as a workaround to prepare products that are pointedly not approved for use, or are used as a means of commercially selling products that require FDA evaluation and approval for sale. The FDA has taken action against a number of pharmacies who have been alleged to contravene federal food and drug regulations. There’s been little action from pharmacy regulators themselves against these practices.

Unfortunately for patients, a network of pharmacies continues to facilitate the provision of compounded chelation therapies, in the absence of any persuasive evidence to support their use. That state and provincial pharmacy regulators ignore these activities is an embarrassment to the profession of pharmacy, and consumers quite literally are paying the price.

Posted in: Health Fraud, Medical Ethics, Pharmaceuticals

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