Chelation Therapy: What You Need to Know

Chelation therapy has been receiving a lot of attention lately for the accumulating evidence of its effectiveness in treating patients – but also from regulators whose recent actions threaten to eliminate access to important chelation drugs.

Is Chelation Safe?

Despite concerns voiced by regulators, recent evidence has shown that intravenous therapy with edetate disodium (EDTA) to treat cardiovascular disease is safe. In a study of the NIH-sponsored Trial to Assess Chelation Therapy (TACT), Dr. Jeanne Drisko and coauthors concluded, “The experience with 55,222 infusions of edetate disodium or placebo in TACT shows that this therapy is safe when used according to the TACT safe infusion protocol.”¹

What Are the Threats to Future Access?

Recent events show a number of reasons to be concerned about continuing access to chelation therapy in your practice.

FDA compounding rules

. In 2013, Congress passed the Drug Quality and Security Act, which tightened federal control over compounding pharmacies. This law set guidelines for what can be compounded at “traditional” pharmacies (503A facilities) and outsourcing pharmacies (503B facilities). Among other things, these rules limit the substances that can be compounded by traditional pharmacies to those that (1) have US Pharmacopoeia monographs, (2) are components of approved drugs, or (3) appear on a preapproved list by the FDA. 503B facilities will only be able to compound drugs that appear on a separate preapproved list, which has not yet been finalized.

Recent meetings strongly suggest that many natural substances and substances used by integrative doctors are being rejected for inclusion on the FDA’s preapproved list for 503A pharmacies, meaning that they will be illegal to compound. An FDA advisory committee has already rejected curcumin, aloe vera, boswellia, and acetyl-L-carnitine, to name just a few.

This means that it is extremely unlikely that doctors and patients will continue to have access to:

• compounded chelation drugs such as dimercaptosuccinic acid (DMSA)

• DMPS (sodium 2,3-dimercaptopropane-1-sulfonate)

• Compounded IV nutrients

• Compounded supplements (even though many supplements have monographs, the FDA has said supplements must be preapproved to be legally compounded)

Recent regulations have also made it illegal for doctors to keep compounded medications from 503A facilities in their offices without a prescription, a practice known as “office use.” This has increased the cost of these medications, not to mention the added hassle for patients. Medications without prescriptions from 503B facilities can continue, but the list of medications that can be legally compounded by 503B facilities will be limited.

EDTA on the chopping block?

In response to patient deaths allegedly linked to chelation therapy, the FDA is reviewing the “benefit/risk profile of [EDTA] to determine if the benefits of its intended use continue to outweigh the serious risks.”² Given the agency’s antipathy toward integrative medicine, it is likely to take action against EDTA.

State medical board hostility

. State medical boards have been historically aggressive toward doctors using chelation therapy – totaling 194 actions over 40 years. Mostly these actions have been against doctors using chelation without proving heavy metal toxicity with a blood – even though blood tests are not a reliable measure for heavy metal toxicity, since metals circulate in blood for a short time before concentrating in tissue. Medical boards in Tennessee, New Hampshire, and Oregon have taken official positions on chelation that threaten action against doctors’ using chelation beyond FDA-approved uses.³

What Can You Do?

• Follow the developments regarding chelation therapy at ANH-USA.org.

• Participate in ANH-USA action alerts that urge lawmakers and regulators to preserve access to chelation therapy.

• Share your story with ANH-USA at http://www.anh-usa.org/contact-anh-usa.

Notes

1. Drisko JA, Alexander KP, Roberts RS, et al. Poster: post-myocardial infarction treatment with edetate disodium was safe in the Trial to Assess Chelation Therapy (TACT). TACT chelation infusion: disodium EDTA, 3 grams, adjusted downward based on eGFRl ascorbic acid, 7 grams; magnesium chloride, 2 grams; potassium chloride, 2 mEq; sodium bicarbonate, 840 mg; pantothenic acid, thiamine, pyridoxine; procaine, 100 mg; unfractionated heparin, 2500 U; sterile water to 500 mL

2. Information on edetate disodium (marketed as Endrate and generic products) [web page]. FDA. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113736.htm.

3. See, for example, this position statement from the Tennessee Board of Medical Examiners: https://www.tn.gov/assets/entities/health/attachments/g4015060.pdf.