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Excessive toxic metal exposure from the air, food, water, dental amalgams, and other sources is becoming a recognized and established underlying cause of both acute and chronic disease. With ongoing medical research validating the link between chronic diseases like heart disease and environmental exposure to toxic metals, it is more important than ever for doctors and patients to be well-informed about the detrimental effects of toxic metals and the potential treatments for heavy metal toxicity, including IV chelation therapy.

What is chelation?

The Greek word “chele” means claw. Chelation is the binding of metals (like lead) or minerals (like calcium) to a protein “chelator” in a pincer-like fashion, forming a ring-like structure. Chelation is an important treatment protocol for the removal of toxic metals such as lead and mercury from the body’s bloodstream and tissues. Natural chelation, although weak, regularly occurs from eating certain foods such as onions and garlic. A stronger chelation effect can be induced when certain supplements, such as some amino acids, are taken orally. The strongest chelation effect is achieved with intravenous chelation. 

What is chelation used for?

Intravenous chelation therapy is used and accepted within conventional medicine as an FDA-approved treatment for the removal of toxic minerals such as lead from the body in cases of severe poisoning. However, it is also used in a  less conventional way: the repeated administration of intravenous chelating agents is used to reduce blood vessel inflammation caused by specific toxic metals and to reduce the body’s total load of those metals, especially lead. It has been shown that the risk of dying from cardiovascular events begins when a person’s blood level of lead is still well within the established normal reference range.[1]

IV chelation therapy often utilizes the chelating agent disodium ethylene diamine tetraacetic acid (EDTA) and is sometimes referred to as EDTA chelation. EDTA chelation is being used in the treatment of all forms of atherosclerotic cardiovascular disease, especially heart disease and peripheral artery disease. Although there is less published research in these areas, chelation therapy is also being used to treat macular degeneration; osteoporosis; mild to moderate Alzheimer’s disease associated with heavy metal toxicity; autoimmune diseases, especially scleroderma; and fibromyalgia or chronic fatigue syndrome with high levels of toxic metals detected with a challenge test.[4]

Does chelation really work?

The most recent study to examine the effects of EDTA chelation therapy showed compelling value for preventing cardiovascular events, especially in people with diabetes who had a history of heart attack. The controversial Trial to Assess Chelation Therapy, or TACT, found an amazing 40% reduction in total mortality, 40% reduction in recurrent heart attacks, and about a 50% reduction in overall mortality in patients with diabetes who had previously suffered from a heart attack.[2] TACT was a large, randomized, placebo-controlled study published in JAMA that randomized patients to a series of IV chelation using EDTA or placebo.[3]

What kinds of doctors offer IV chelation therapy?

Doctors must be well-trained in chelation therapy in order to utilize the correct tests and treatments. Testing for toxic metal exposure is not straightforward since blood tests typically identify only those with severe and acute toxicity but fail to identify those with toxic metals stored in the tissues due to chronic exposure. Applying the appropriate chelating agent to properly treat toxic metal accumulation is also not a straightforward endeavor. Different chelating agents bind with different affinity to different metals. Some chelating agents may be taken orally, while others are administered intravenously.

Chelation therapy is not taught in conventional medical school but rather through various professional medical organizations. The most recognized leader in educating and certifying healthcare professionals, including MDs and NDs, in chelation therapy is the American College for the Advancement of Medicine (ACAM). ACAM’s chelation therapy training teaches doctors how to diagnose and treat patients with heavy metal toxicity as well as how to use diet and nutrients to optimize toxic metal chelation strategies and protocols.

[1] ACAM website. Detoxification / IV Chelation. Downloaded Jan 7, 2014.

[2] Medscape Heartwire. 2013, Nov 19. ‘Extraordinary’ Chelation Effects…. Downloaded Jan 7, 2014.

[3] JAMA. 2013;309(12):1241-1250.

[4] Townsend Ltr. 2013 Aug/Sept. Report on the Proceedings of a Summit…. Downloaded Jan 7, 2014.

This article was originally published in 2014 and has been updated.

Today, the U.S. Food and Drug Administration issued a final rule amending FDA’s list of drug products that may not be compounded under certain sections of the Food, Drug, and Cosmetic Act (FD&C Act) that allow the marketing of unapproved compounded drugs.

Drug products on the list may not be compounded because the drug products have been withdrawn or removed from the market for safety or effectiveness reasons. The list appears in the Code of Federal Regulations at Title 21, section 216.24.

The final rule:

• Adds 24 types of drugs to the withdrawn or removed list.
• Modifies the withdrawn or removed list to allow one type of drug product to be compounded under certain circumstances.
• Clarifies that the withdrawn or removed list applies to sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

In addition, FDA published a discussion in the Federal Register that clarifies the procedure FDA intends to use to amend the withdrawn or removed list.

FDA’s website has additional information on compounding.

Flint, Michigan recently declared a "State of Emergency" in the wake of lead contaminated drinking water. As a result, we are once again faced with the age-old discussion regarding the health implications of lead accumulation. We know that protecting all people from lead exposure is extremely important to lifelong good health. Children, however, are particularly vulnerable to the harmful effects of lead because they absorb lead much more readily than adults. The current controversy over treatment revolves around three questions:

1. Who should be considered at higher risk for harm and offered treatment?
2. What treatments should be offered to individuals with elevated lead levels?
3. At what blood lead level burden is it appropriate to start therapy?

Unfortunately, this tragedy goes far beyond Flint, Michigan. People worldwide continue to be exposed to potentially harmful levels of many toxic metals that can profoundly affect their health. They face potentially enduring, serious and complicated health issues.  Perhaps the major question, especially in children, is the level of lead in the blood to cause concern.

The CDC states, “Experts now use a reference level of 5 micrograms per deciliter to identify children with blood lead levels that are much higher than most children’s levels. This new level is based on the U.S. population of children ages 1-5 years who are in the highest 2.5% of children when tested for lead in their blood.  In the past, blood lead level tests below 10 micrograms per deciliter of lead in blood may, or may not, have been reported to parents. The new lower value means that more children will likely be identified as having lead exposure allowing parents, doctors, public health officials, and communities to take action earlier to reduce the child’s future exposure to lead.”

The CDC also states, “What has not changed is the recommendation for when medical treatment is advised for children with high blood lead exposure levels. The new recommendation does not change the guidance that the therapy used to eliminate lead from the body be considered only when a child has been tested with a blood lead test result greater than or equal to 45 mcg/dL.” [http://www.cdc.gov/nceh/lead/ACCLPP/blood_lead_levels.htm]

However, medical science has determined that even very low blood lead levels in children can affect IQ, ability to pay attention and future academic achievement. It is now clear that IQ loss in lead-exposed children can occur at levels below 5.0 mcg/dL. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2212280/, from Neurotoxicology, 2006 Sep; 27(5): 693–701.

The American College for Advancement in Medicine (ACAM), an educational organization and a leading authority in the field of heavy metal toxicity and treatment believes, as the CDC does, that “no safe blood lead level in children has been identified.” The effects of lead exposure on child cognitive development and behavior may be permanent if no intervention occurs. Experts from ACAM believe that certain interventions may be useful in lessening the symptoms and long-term neurocognitive damage that lead causes in children.

ACAM experts also contend that the myriad, harmful effects that lead can cause in other organ systems in people of any age should also be lessened. The original guidelines for intervention in lead poisoning were based on early FDA drug approval studies from the minimal research conducted in pediatric patients with blood lead levels above 45 mcg/dL. ACAM believes that appropriate medical intervention may be beneficial to those suffering from lead levels even at the current CDC cutoff of 5 mcg/dl, the level that places the child in the upper 2.5% of tested individuals.

Due to the lack of current, cohesive, long-term studies in children with elevated blood levels below 45 mcg/dL, the decision when to initiate chelation therapy is a personal choice between a patient and their physician. To better elucidate what is the best treatment strategy for lead poisoning, ACAM is calling for the immediate initiation of a collaborative long-term research project. The project, conducted through appropriate channels, could provide immediate medical attention and intervention to all children and adults in Flint who have high blood lead levels (>5 mcg/dl). This research project should also investigate assessing those common genetic and metabolic defects that could render individuals even more susceptible to the harmful effects of lead.

We can take a more proactive approach to prevent permanent damage and disability not only in the population of Flint, MI but to everyone exposed to the potential devastation caused by lead.

ABOUT ACAM:
The American College for Advancement in Medicine (ACAM) is a not-for-profit organization dedicated to educating physicians and other health care professionals on the safe and effective application of integrative medicine. ACAM's healthcare model focuses on prevention of illness and strives for total wellness. ACAM has been educating physicians in metal removal techniques such as chelation therapies since 1973. A recent NIH sponsored study has demonstrated that the chelation technique using EDTA is safe when it is used by physicians educated in these techniques.

FIND A PHYSICIAN NEAR YOU FOR ASSISTANCE:
ACAM offers Physician+Link – a free service provided to the public for finding integrative practitioners in their area. Call 1.800.532.3688 for personal assistance or visit www.acam.org/ACAMPL

ADDITIONAL RESOURCES:
A rationale for lowering the blood lead action level from 10 to 2 μg/dL

Effect of Chelation Therapy on the Neuropsychological and Behavioral Development of Lead-Exposed Children After School Entry

American Academy of Pediatrics: Lead Exposure in Children: Prevention, Detection, and Management

Safety and Efficacy of DMSA in children with elevated blood level concentrations

Children with moderately elevated blood lead levels: a role for other diagnostic tests?

What level of lead in blood is toxic for a child?