Chelation Therapy:

Chelation therapy, as discussed in this article, is a series of intravenous infusions containing disodium EDTA and various other substances. It is sometimes done by swallowing EDTA or other agents in pill form. Proponents claim that EDTA chelation therapy is effective against atherosclerosis and many other serious health problems. Its use is widespread because patients have been led to believe that it is a valid alternative to established medical interventions such as coronary bypass surgery. However, there is no scientific evidence that this is so. It is also used to treat nonexistent "lead poisoning," "mercury poisoning," and other alleged toxic states that practitioners diagnose with tests on blood, urine, and/or hair.

The proponents' viewpoints have been summarized in four books: The Chelation Answer: How to Prevent Hardening of the Arteries and Rejuvenate Your Cardiovascular System (1982), by Morton Walker, D.P.M., and Garry Gordon, M.D.; Chelation Therapy: The Key to Unclogging Y our Arteries (1985), by John Parks Trowbridge, M.D., and Morton Walker D.P.M.; A Textbook on EDTA Chelation Therapy (1989), by Elmer M. Cranton, M.D.; and Bypassing Bypass: The New Technique of Chelation Therapy (2nd edition, 1990), by Elmer Cranton, M.D., and Arline Brecher. The scientific jargon in these books may create the false impression that chelation therapy for atherosclerosis, and a host of other conditions, is scientifically sound. The authors allege that between 300,000 and 500,000 patients have safely benefited. However, their evidence consists of anecdotes, testimonials, and poorly designed experiments.

The primary organization promoting chelation therapy is the American College for Advancement in Medicine (ACAM), which was founded in 1973 as the American Academy for Medical Preventics. Since its inception, ACAM's focus has been the promotion of chelation therapy. The group conducts courses, sponsors the American Journal of Advancement in Medicine, and administers a "board certification" program that is not recognized by the scientific community. ACAM's online directory lists about 850 members, about 550 of whom indicate that they practice chelation therapy.

In 1989, an ACAM protocol for "the safe and effective administration of EDTA chelation therapy" was included in Cranton's "textbook," a 420-page special issue of the journal that contains 28 articles and a foreword by Linus Pauling.

Proponents claim that chelation therapy is effective against atherosclerosis, coronary heart disease, and peripheral vascular disease. Its supposed benefits include increased collateral blood circulation; decreased blood viscosity; improved cell membrane function; improved intracellular organelle function; decreased arterial vasospasm; decreased free radical formation; inhibition of the aging process; reversal of atherosclerosis; decrease in angina; reversal of gangrene; improvement of skin color, healing of diabetic ulcers. Proponents also claim that chelation is effective against arthritis; multiple sclerosis; Parkinson's disease; psoriasis; Alzheimer's disease; and problems with vision, hearing, smell, muscle coordination, and sexual potency. None of these claimed benefits has been demonstrated by well-designed clinical trials.

In a retrospective study of 2,870 patients treated with NaMgEDTA, Olszewer and Carter (1989) concluded that EDTA chelation therapy benefited patients with cardiac disease, peripheral vascular disease and cerebrovascular disease. These conclusions were not justified because the people who received the treatment were not compared to people who did not.

More recently, the results of two randomized, controlled, double-blind clinical trials of chelation therapy were published in peer-reviewed German medical journals. The first was conducted by Curt Diehm, M.D., at the University of Heidelberg Medical Clinic . Diehm studied 45 patients who had intermittent claudication, a condition in which impaired circulation causes the individual to develop pain in the legs upon walking. About half of the patients were treated with EDTA and the rest received Bencyclan, a bloodthinning agent. In addition to determining the effect of each agent on the ability to perform pain-free walking exercises, Diehm measured the progress of the disease process in each patient during the four-week treatment period and three months after treatment was stopped. Statistical evaluation of the results after the blinding code was broken showed that patients in both groups had equally increased ability to perform pain-free walking exercises and that treatment with EDTA did not result in any change in the patients' blood flow, red cell viscosity, red-cell aggregation, or triglyceride and cholesterol levels. Diehm also concluded that the improvements in walking measurements in both groups were directly related to his success in convincing them of his strong interest in their well being and his ability to motivate them to make an effort to perform greater activity.

This is an excerpt from a 1996 flyer from an osteopathic physician whose radio advertisements invite people who have been advised to have coronary bypass surgery to consult him first. There is no published scientific evidence that chelation therapy can render bypass surgery unnecessary or can help people with any of the conditions listed in the ad.

Rebuttal: Plaque is an integral part of the artery wall and not a deposit on its surface. Calcium enters arterial plaque in the late stages of its enlargement. Since EDTA cannot pass through the artery cell membranes it cannot chelate the calcium there. Chelation proponents have never presented evidence that chelation therapy causes softening of hardened arteries, removes calcium from arterial plaque or causes the plaque structure to disintegrate.

Since EDTA infusion solutions include megadoses of vitamin C, the possibility exists that chelation therapy will increase the formation of free radicals that cause tissue damage!

Proposed mechanism #4: Chelation therapy prevents mutations of cells that become an atheroma. Atheromas are benign tumors that arise from mutated artery cells. Artery cells mutate when their DNA is damaged by free radicals. When these cells grow, they become a benign tumor called an atheroma (plaque).

In October 1989, chelation therapy was listed as one of "The Top Ten Health Frauds" in an article in FDA Consumer. The article reported that both the FDA and the American Heart Association have said that there is no scientific evidence that chelation therapy is effective against cardiovascular disease.

Three issues later, a letter from a proponent complained that the listing was inappropriate because the FDA had approved the protocol of a clinical trial that was underway. The letter was followed by "an apology for the error," which stated that the editor had not been aware that chelation therapy had been approved for a study. The editor's note also quoted an FDA official who said that the study should "unequivocally answer at least several questions related to the utility of chelation therapy in . . . intermittent claudication."

Chelation therapists state they have administered millions of EDTA treatments to hundreds of thousands of patients over the past 40 years. Protagonist publications contain their claims of numerous clinical successes and speculations couched in modern scientific terms, seeking to explain how chelation therapy could work. Since there is no evidence showing the treatment has modified the disease process, it is clear that the "benefits" being described are the result of the compassionate attention paid to the problems of the patient and to the encouragement given them to cope with their symptoms, and/or to changes in patients' lifestyle, the same ones recommended by scientific practitioners

"Chelation therapy is a safe, effective and relatively inexpensive treatment to restore blood flow in victims of atherosclerosis without surgery."

"Chelation therapy is used to reverse symptoms of hardening of the arteries, also known as atherosclerosis or arteriosclerosis."

"Every single study of the use of chelation therapy for atherosclerosis which has ever been published, without exception, has described an improvement in blood flow and symptoms."

"Chelation therapy promotes health by correcting the major underlying cause of arterial blockage. Damaging oxygen free radicals are increased by the presence of metallic elements and act as a chronic irritant to blood vessel walls and cell membranes. EDTA removes those metallic irritants, allowing leaky and damaged cell walls to heal. Plaques smooth over and shrink, allowing more blood to pass. Arterial walls become softer and more pliable, allowing easier expansion. Scientific studies have proven that blood flow increases after chelation therapy."

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Chelation Therapy and Insurance Fraud

Chelation therapy is a series of intravenous infusions containing EDTA and various other substances. It is claimed to be effective against kidney and heart disease, arthritis, Parkinson's disease, emphysema, multiple sclerosis, gangrene, psoriasis, and many other serious conditions. However, no well-designed research has shown that chelation therapy can help these conditions and manufacturers of EDTA do not list them as appropriate for EDTA treatment. A course of treatment consisting of 20 to 50 intravenous infusions costs several thousand dollars.

Chelation therapy is heavily promoted as an alternative to coronary bypass surgery. It is sometimes claimed to be a "chemical Roto-Rooter" that can clean out atherosclerotic plaque from the body's arteries. However, there is no evidence that it can do this. The organizations that have criticized chelation claims include the American Heart Association, FDA, the National Institutes of Health, the National Research Council, the California Medical Society, the American Medical Association, U.S.Centers for Disease Control and Prevention, American College of Physicians, the American Academy of Family Physicians, American Society for Clinical Pharmacology Therapeutics, American College of Cardiology, American Osteopathic Association, and Federal Trade Commission (FTC).

The primary organization promoting chelation therapy is the American College for Advancement in Medicine (ACAM), which was founded in 1973 as the American Academy for Medical Preventics. Since its inception, ACAM's focus has been the promotion of chelation therapy. The group conducts courses, sponsors the American Journal of Advancement in Medicine, and administers a "board certification" program that is not recognized by the scientific community. The 1998 edition of Encyclopedia of Medical Organizations and Agencies stated that ACAM had 535 members.

In 1989, an ACAM protocol for "the safe and effective administration of EDTA chelation therapy" was included in a 420-page special issue of the journal. The protocol calls for intravenous infusion of 500 to 1,000 ml of a solution containing 50 mg of disodium EDTA per kilogram of body weight, plus heparin, magnesium chloride, a local anesthetic (to prevent pain at the infusion site), several B-vitamins, and 4 to 20 grams of vitamin C. This solution is infused slowly over 3.5 to 4 hours, one to three times a week. Additional vitamins, minerals, and other substances—prescribed orally—"vary according to preferences of both patients and physicians." Lifestyle modification, which includes stress reduction, caffeine avoidance, alcohol limitation, smoking cessation, exercise, and nutritional counseling, is encouraged as part of the complete therapeutic program. The number of treatments to achieve "optimal therapeutic benefit" for patients with symptomatic disease is said to range from 20 ("minimum"), 30 (usually needed), or 40 ("not uncommon before benefit is reported") to as many as 100 or more over a period of several years. "Full benefit does not normally occur for up to 3 months after a series is completed," the protocol states—and "follow-up treatments may be given once or twice monthly for long-term maintenance, to sustain improvement, and to prevent recurrence of symptoms." The cost, typically $75 to $125 per treatment, is not covered by most insurance plans. Chelation therapy is one of several legitimate methods for treating cases of heavy metal poisoning, but the protocols differ from the ACAM protocol.

"Chelation therapy is a safe, effective and relatively inexpensive treatment to restore blood flow in victims of atherosclerosis without surgery."

"Chelation therapy is used to reverse symptoms of hardening of the arteries, also known as atherosclerosis or arteriosclerosis."

"Every single study of the use of chelation therapy for atherosclerosis which has ever been published, without exception, has described an improvement in blood flow and symptoms."

"Chelation therapy promotes health by correcting the major underlying cause of arterial blockage. Damaging oxygen free radicals are increased by the presence of metallic elements and act as a chronic irritant to blood vessel walls and cell membranes. EDTA removes those metallic irritants, allowing leaky and damaged cell walls to heal. Plaques smooth over and shrink, allowing more blood to pass. Arterial walls become softer and more pliable, allowing easier expansion. Scientific studies have proven that blood flow increases after chelation therapy."

"Chelation therapy is an office treatment which improves blood flow throughout the entire vascular system . . .."The reader is advised that varying and even conflicting views are held by other segments of the medical profession. . . . This information represents the current opinion of independent physician consultants to ACAM at the time of publication."

In December 1998, the FTC announced that it had secured a consent agreement barring ACAM from making unsubstantiated advertising claims that chelation therapy is effective against atherosclerosis or any other disease of the circulatory system. The cease-and-desist order is binding only on ACAM itself, not its individual members. Although the FTC could bring action against individual doctors who advertise falsely, it usually leaves that up to the state licensing boards. A few chelation therapists have had their licenses revoked, but most practice without government interference.

Because chelation has legitimate use for treating heavy metal poisoning, some chelation therapists submit fraudulent insurance reports claiming to have treated lead poisoning or another alleged toxic state. Lead poisoning in adults is uncommon and occurs primarily through (a) occupational exposure or (b) repainting an old house that had been painted with lead paint without taking proper precautions. The standard test for lead poisoning is a blood lead level, but some chelation therapists test urine and/or hair. If lead poisoning actually exists, whether discontinuation of exposure is sufficient treatment or chelation therapy should be administered depends on the blood lead concentration, the severity of clinical symptoms, the biochemical and blood abnormalities, and the nature of the exposure. The following questions can help identify deceptive insurance claims:

Do the dates of administration fit a protocol for lead poisoning treatment? Chelation therapy that spans several months should be regarded with great suspicion.

Has the doctor ever submitted a chelation therapy for any other claim?

Is the doctor an ACAM member or known to do chelation therapy for cardiovascular disease? An ACAM directory can be accessed online. (The complete list can be accessed by searching with a comma in the "Last Name" box.)

Do the blood levels justify doing chelation rather than simply advising the person to avoid further exposure or treating the person with oral medication? In adults, the use of chelation therapy should be reserved for those with significant symptoms or signs of toxicity.

Ask for a list of the ingredients (and doses) the doctor uses for chelation therapy, the name of the manufacturer and supplier, and a copy of the product label. Calcium EDTA is a legitimate chelating agent for lead poisoning. However, if the intravenous solution contains disodium EDTA, DMPS, vitamins, or any other ingredients in the ACAM protocol, you can conclude that the treatment is not appropriate for lead poisoning.

Telephone the doctor's office to see what prospective patients are told about chelation therapy, what it costs, and whether it is covered by insurance.

Some chelation therapists don't mention using chelation therapy but use the procedure code for standard intravenous treatments. Thus it would be wise for insurance companies to set up screening procedures to detect chelation services disguised as "infusion therapy."

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EDTA Chelation Therapy for

Planned clinical trials of ethylene-diamine-tetra-acetic acid (EDTA) chelation therapy by the National Center for Complementary and Alternative Medicine and others call for investigation of chelation's biochemistry and pharmacology, its toxicity, and the history of claims made for it.

EDTA Chelation Therapy Protocol

A review of literature data to 1984 concluded, " Chelation therapy with intravenous injections of edetate sodium . . . promoted to treat coronary and other arterial atherosclerosis . . . evidence . . . is lacking." Based on reviews of the world medical literature, these same conclusions were reached by the U.S. Food and Drug Administration, the National Institutes of Health, the National Academy of Sciences and National Research Council, the California Medical Association, the American Medical Association, the Centers for Disease Control, the American Heart Association, the American College of Physicians, the American Academy of Family Practice, the American Society for Clinical Pharmacology Therapeutics, the American College of Cardiology, and the American Osteopathic Association .

Meanwhile the intestinal tract absorbs 0.5-1.0 gm of calcium daily from the diet, while renal conservation occurs as well, if compensatory mechanisms function normally, no net calcium loss from EDTA chelation therapy would occur.

The U.S. Federal Trade Commission in 1998 cobtained a consent order barring the ACAM not to advertise EDTA chelation therapy as effective. However, the agreement does not bind individual physicians, who may advertise and practice chelation. The ACAM and supporters succeeded in having 10 states pass "Access to Medical Treatment Acts" (AMTA), the latest being Colorado and Minnesota. These bills forbid state medical boards from disciplining physicians for using ineffective treatments as long as patients agree to receive them. The province of Ontario passed a similar bill, and other bills are before other state and provincial legislative bodies. A similar U.S. federal bill has appeared over the last 6 years but has not passed.

Trowbridge J, Gordon G. Chelation Therapy. Greenwich, CT Devin Adair, 1985.

Cranton E. A Textbook on EDTA Chelation Therapy. New York, NY: Human Sciences Press, Inc.; 1990.

Clarke N. EDTA chelation therapy. Am J Cardiol. 1960;6:233-236.

Chappell L. Chelation therapy should be used more commonly in treatment of vascular disease. Alt Ther Health Med. 1995;1(2):53-57.

Chappell L, Stahl J, Evans R. EDTA chelation therapy for vascular disease: a meta-analysis using unpublished data. J Adv Med. 1994;7:131-142.

Margolis S. Chelation therapy is ineffective for treatment of peripheral vascular disease. Alt Ther Health Med. 1995;1(2):53-57.

Anon. AMA Council on Scientific Affairs: chelation therapy.

Hopf R. The test of alternative medicine: chelation therapy.

Ernst E. Chelation therapy for peripheral arterial disease: a systematic review. Circulation. 1997;96(3):1931-1933.

Sampson W. Pharmacology of chelation therapy. Sci Rev Alt Med. 1997;1(1):25-27.

In December 1996 and January 1997, when Hough was 55 years old, Sinnathamby falsely promised that chelation therapy would clean out his arteries and make him feel generally more energetic.

(d) held himself out as a specialist providing chelation therapy treatment involving the use of Ethylene Diamine Tetraacetic Acid for members of the public requiring the same.

5. The Plaintiff attended the First Defendant and engaged the First Defendant for reward as his specialist medical practitioner to provide advice and information regarding the provision of chelation therapy to the Plaintiff.

(a) alternatively, the Plaintiff attended the First Defendant as the servant and/or agent of the Second Defendant to obtain advice and information regarding the provision of chelation therapy to the Plaintiff.

8. In reliance upon the advice provided by the First Defendant the Plaintiff attended at the Second Defendant's premises and received chelation therapy treatment administered by the First Defendant and the Second Defendant's servants and or agents.

11. The Plaintiff received chelation therapy treatment on the following dates:

12. The Plaintiff did not display the recognised indicators for chelation therapy such as:

13. As a consequence of the chelation therapy the Plaintiff had received, the Plaintiff sustained injuries which included suffering a cardiac arrest on the 14th January 1997 which required the Plaintiff to be resuscitated from ventricular fibrillation.

(a) failing to provide any or any appropriate advice to the Plaintiff of the risks and possible consequences of undertaking chelation therapy;

(b) failing to provide any or any appropriate warning to the Plaintiff regarding the risk of the Plaintiff suffering a cardiac arrest following the provision of chelation therapy;

(d) failing to undertake any or any appropriate investigations, examinations or tests or sufficient investigations, examinations or tests to ascertain whether the Plaintiff was a suitable candidate for chelation therapy;

(e) failing to provide any or any appropriate monitoring of the Plaintiff following the provision of the chelation therapy treatment.

(a) failing to provide any or any appropriate advice to the Plaintiff of the risks and possible consequences of undertaking chelation therapy;

(b) failing to provide any or any appropriate warning to the Plaintiff regarding the risk of cardiac arrest following the provision of chelation therapy;

(c) failing to undertake any or any appropriate investigations, examinations or tests or sufficient investigation, examinations or tests or ascertain whether the Plaintiff was a suitable candidate for chelation therapy;

(d) failing to provide any or any appropriate monitoring of the Plaintiff following the provision of the chelation therapy treatment;

(e) failing to ensure that the Second Defendant's servants or agents assisting the First Defendant possessed the requisite competency, experience and skill so as to ensure that no injury would be occasioned to the Plaintiff by the chelation therapy.

(a) failing to provide any or any appropriate advices to the Plaintiff of the risks and possible consequences of undertaking chelation therapy;

(b) failing to provide any or any appropriate warning to the Plaintiff regarding the risk of the Plaintiff suffering a cardiac arrest following the provision of chelation therapy;

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Over Promotion of "Chelation Therapy"

The American College for Advancement in Medicine (ACAM) has agreed to settle Federal Trade Commission charges that it made unsubstantiated and false advertising claims that non-surgical, EDTA "chelation therapy" is effective in treating atherosclerosis, and that the effectiveness of the therapy has been proven by scientific studies. The proposed settlement would prohibit ACAM from representing, in advertising, that chelation therapy is an effective treatment for atherosclerosis without possessing and relying upon competent and reliable scientific evidence to support the representation.

In addition, ACAM would be prohibited from making any representation about the efficacy or comparative efficacy of chelation therapy for any disease of the human circulatory system unless supported by competent and reliable scientific evidence.

ACAM, based in Laguna Hills, California, is an association comprised principally of physicians who administer traditional and complementary/alternative medical therapies including chelation therapy. ACAM promotes chelation therapy in brochures and promotional materials and by maintaining a Web page on the Internet. Chelation therapy involves the intravenous injection of a prescription drug, ethylene diamine tetra acetic acid (EDTA), which is approved by the Food and Drug Administration for the limited use of ridding the human body of excess heavy metals.

According to the FTC's complaint detailing the charges, ACAM's advertisements and promotional materials for chelation therapy contained such statements as:

Chelation therapy is a safe, effective, and relatively inexpensive treatment to restore blood flow in victims of atherosclerosis without surgery;

Every single study of the use of chelation therapy for atherosclerosis which has ever been published, without exception, has described an improvement in blood flow and symptoms; and

Chelation therapy promotes health by correcting the major underlying cause of arterial blockage. Damaging oxygen free radicals are increased by the presence of metallic elements and act as a chronic irritant to blood vessel walls and cell membranes. EDTA removes those metallic irritants, allowing leaky and damaged cell walls to heal. Plaques smooth over and shrink, allowing more blood to pass. Arterial walls become softer and more pliable, allowing easier expansion. Scientific studies have proven that blood flow increases after chelation therapy.

Through the use of such statements, the FTC alleged, ACAM has represented that EDTA chelation therapy is an effective treatment for atherosclerosis, and that ACAM possessed and relied upon a reasonable basis when making the representations.

The proposed settlement, announced today for a public comment period, would prohibit ACAM from representing that EDTA chelation therapy is an effective treatment for atherosclerosis without possessing and relying upon competent and reliable scientific evidence to substantiate the representations.

In addition, the proposed settlement would require ACAM to possess competent and reliable scientific evidence to support any claims about the effectiveness or comparative effectiveness of chelation therapy for any disease of the human circulatory system.

The proposed settlement would also prohibit ACAM from misrepresenting the existence, validity, results, or contents of any test, study, or research in connection with the advertising or promotion of chelation therapy.

3. Respondent trained as a psychiatrist and engaged in that practice specialty for many years. He has changed his practice and now practices what he describes as chelation therapy, environmental medicine, and general medicine, and a small amount of psychiatry.

He, on information and belief, has obtained recognition from three groups not recognized by the American Board of Medical Specialties: the "American Academy of Environmental Medicine," the "American Board of Chelation Therapy," and the "American College for the Advancement of Medicine."

6. Respondent caused or authorized to be published in the August 17, 1996 (Sunday) Green Bay Press-Gazette, a general circulation newspaper, an advertisement which stated that a "typical" patient treated with chelation therapy reported that his coronary artery blockage was halved by respondent's chelation therapy, and that "chelation therapy is an effective way to not only combat, but reverse some of the effects of atherosclerosis." Such advertising is false, misleading or deceptive contrary to § Med 10.02(2)(o), Wis. Adm. Code and constitutes unprofessional conduct.

14. Chelation therapy is a treatment which involves the infusion of intravenous EDTA into a patient's bloodstream. There are two kinds of EDTA: calcium EDTA and disodium EDTA. Disodium EDTA is used conventionally to remove calcium from the body, and is well accepted for use in cases where a patient has hypercalcemia and digitalis toxicity. Calcium EDTA is used to remove lead from the body in cases of lead poisoning, and is well-accepted for this use. The patient did not have any of these conditions.

D. Chelation therapy is not an indicated treatment for the circulatory problems, or any other conditions which the patient had.

D. Chelation therapy presents the following dangers to any patient, which dangers are exacerbated when used for a condition for which it is not indicated:

Chelation therapy with EDTA can cause atherosclerotic disease by damaging blood vessels.

22. Respondent represented to the patient that chelation therapy would provide effective treatment for circulatory problems or another condition which the patient had.

23. In fact, chelation therapy is not an effective treatment for any of the patient's conditions.

24. Respondent knew or should have known that chelation therapy would not provide the treatment results represented by Respondent for circulatory problems (or any other condition which the patient had) or Respondent did not have sufficient knowledge of the truth or falsity of these representations and therefore made them without attempting to determine their validity.

33. Respondent administered chelation therapy to this patient, and informed the patient's cardiologist that he was doing so.

B. Chelation therapy presents the following dangers to any patient, which dangers are exacerbated when used for a condition for which it is not indicated:

Chelation therapy with EDTA can cause atherosclerotic disease by damaging blood vessels.

C. Chelation therapy presents the following dangers to any patient, which dangers are exacerbated when used for a condition for which it is not indicated:

Chelation therapy with EDTA can cause atherosclerotic disease by damaging blood vessels.

65. The lead level did not justify chelation therapy, and respondent did not use calcium EDTA for the therapy, which would have been the correct form of EDTA to use if the patient had lead poisoning, but instead used disodium EDTA. Further, his order for chelation therapy did not specify the content of the solution to be infused, and thus was invalid as a physician's order. Notwithstanding this, the patient received 38 chelation infusions between 3/22/93 and 1/12/94.

B. Chelation therapy presents the following dangers to any patient, which dangers are exacerbated when used for a condition for which it is not indicated:

Chelation therapy with EDTA can cause atherosclerotic disease by damaging blood vessels.

69. Additionally, respondent's treatment of the patient by use of chelation therapy, which had no effect upon her cholesterol, constituted excessive and ineffective treatment, and for respondent to continue this treatment even after it failed to reduce her cholesterol constituted an effort to obtain a fee by fraud or deceit, and was unprofessional conduct pursuant to § Med 10.02(2)(m), Wis. Adm. Code.

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Why Chelation Therapy Should Be Avoided

Chelation therapy is a series of intravenous infusions containing EDTA

Chelation Therapy: Unproven Claims and Unsound Theories

Chelation Therapy and Insurance Fraud

Questions and Answers about Chelation Therapy (American Heart Association)

EDTA Chelation Therapy for Atherosclerosis and Degenerative Diseases: Implausibility and Paradoxical Oxidant Effects

FTC Action against Organization Promoting Chelation Therapy

Part III: Required Disclosure Form for Chelation Therapy

Despite all of this, Doctor's Data's reports classify mercury values in the range of 5-10 µg/g as "elevated" and further state that "no safe reference levels for toxic metals have been established." Practitioners typically receive two copies of the report, one for the practitioner and one to give to the patient. Very few patients understand what the numbers mean. They simply see "elevated" lead or mercury, and interpret the "no safe levels" disclaimer to mean that any number above zero is a problem. The patient is then advised to undergo "detoxification" with chelation therapy, other intravenous treatments, dietary supplements, or whatever else the practitioner happens to sell.

This advice is very, very, very wrong. No diagnosis of lead or mercury toxicity should be made unless the patient has symptoms of heavy metal poisoning as well as a much higher nonprovoked blood level. And even if the level is in the 30s—as might occur in an unsafe workplace or by eating lead-containing paint—all that is usually needed is to remove further exposure. Chelation therapy is rarely necessary.

Chelation therapy is a series of intravenous infusions containing a chelating agent and various other substances. One form of chelation therapy is occasionally used to treat lead poisoning. However, lead poisoning is rare and has well-established diagnostic criteria. Slight elevations of lead levels are not poisoning and need no treatment because the body will lower them when exposure is stopped. Proper diagnosis of lead poisoning requires symptoms of lead poisoning, not just a slightly elevated level. Acute poisoning is always accompanied by a rise in zinc protoporphyrin (ZPP), without which it should not be diagnosed. Chronic poisoning would have severe symptoms that would be obvious to anyone in addition to severely elevated lead (and ZPP) levels.

Doctors who offer chelation therapy as part of their everyday practice typically claim that it is effective against autism, heart disease and many other conditions for which it has no proven effectiveness or plausible rationale . One such case was described in a 2009 decision by the U.S. Court of Federal Claims which found no credible evidence that childhood vaccinations cause autism. In that case, Colton Snyder underwent chelation therapy after a Doctor's Data urine test report classified his urine mercury level as "very elevated." After noting that the urine sample had been provoked (with DMSA) and that provocation artificially increases excretion, the Special Master concluded that a non-provoked test would have placed the result in the normal range. He also noted:

The medical records, including reports from Mrs. Snyder, reflected that Colten did poorly after every round of chelation therapy. . . . The more disturbing question is why chelation was performed at all, in view of the normal levels of mercury found in the hair, blood, and urine, its apparent lack of efficacy in treating Colten’s symptoms, and the adverse side effects it apparently caused .

In 2004, CIGNA HealthCare Medicare Administration, which processes Medicare claims for Idaho, North Carolina, and Tennessee, issued a "Progressive Correction Action Review" which concluded that many claim submissions for chelation therapy had been inappropriate. This conclusion was documented by a study of 40 claims which found that in many cases, "heavy metal toxicity" was inappropriately diagnosed and no need for chelation with edetate calcium disodium was documented. The review criticized provoked testing and noted that it does not provide a basis for diagnosing past or current poisoning .

in 2002, the Medical Board of California charged Ilona Abraham, M.D. with unprofessional conduct, incompetence, gross and repeated negligence, and inadequate recordkeeping in connection with her management two patients. In both cases, Abraham had failed to perform an adequate history and physical examination and had administered chelation therapy after diagnosing heavy metal toxicity based on provoked testing. In 2004, the case was settled by a consent agreement and order under which Abraham agreed to serve three years probation, during which time she would (a) pay about $26,000 for costs, (b) take certain remedial courses, and (c) engage the services of a practice monitor .

Connecticut has included a provoked testing ban in settlement agreements with two practitioners. In 2005, Robban Sica, M.D., signed a consent order under which she was prohibited from using a provoked test to diagnose heavy metal toxicity . In 2006, George Zabrecky, D.C., was ordered to stop all testing that might be preliminary to chelation therapy .

In 2007, the Pennsylvania Board of Medicine temporarily suspended the license of Roy Kerry, M.D. following the death of a a 5-year-old autistic child to whom he administered chelation therapy . In 2009, Kerry signed a consent order under which he was suspended for six more months, to be followed by 2 1/2 years of probation. He was also barred from chelating children under age 18 in the future. Kerry was also sued by the victim's parents .

In 2009, 43-year-old Ronald Stemp sued Jesus Caquias, CARE Clinics, the clinic's owner, and Doctor's Data for fraud, negligence, and conspiracy. The suit petition states that Stemp originally sought help for memory loss, inability to sleep, difficulty concentrating, and depression. After taking a urine toxic metals test and several other tests, he was falsely diagnosed with heavy metal poisoning and advised to undergo intravenous chelation therapy. Stemp's insurance company was reportedly billed for a total of $180,000 . Caquias is also facing charges from the Texas Medical Board .

In February 2010, in a suit against naturopath Mathew Schlechten, a Montana jury awarded $501,007.68 to the widow of John Sisson, who died of a heart attack at age 52 . Testimony in the case indicated that although Schlechten knew that Sisson had anginal pain, he failed to refer him for medical evaluation. Instead he administered chelation therapy after using a provoked urine test to persuade Sisson that he was toxic.

In May 2010, the Texas Medical Board charged "autism specialist" Seshagiri Rao, M.D. with nontherapeutic prescribing, failure to secure informed consent, and fraudulent billing related to his mismanagement of five children with autism or autism spectrum disorder. The complaint states that Rao used an inappropriate urine test to diagnose nonexistent "heavy metal toxicity," inappropriately treated the patients with chelation therapy, and pretended to insurance companies that he was treating heavy metal toxicity rather than autism .

Green S. Chelation therapy: Unproven claims and unsound theories. Quackwatch, July 24, 2007.

Clinical policy bulletin: Chelation therapy. Aetna, revised May 7, 2010.

The Pharmacology of Chelation Therapy

Chelation therapy using small amounts of EDTA is ineffective and could not work the way proponents claim it does. It is still potentially dangerous because it can increase the free radical load instead of reducing it.

Chelation Therapy: Unproven Claims and Unsound Theories (Quackwatch article)

Chelation Therapy and Insurance Fraud (Quackwatch article)

Questions and Answers about Chelation Therapy (American Heart Association)

Pentel P, Jorgensen C, Somerville J. Chelation therapy for the treatment of atherosclerosis. Minnesota Medicine 67(2):101-103, 1984.

false advertising claims that non-surgical, EDTA "chelation therapy"

would prohibit ACAM from representing, in advertising, that chelation therapy

the efficacy or comparative efficacy of chelation therapy for any disease

medical therapies including chelation therapy. ACAM promotes chelation therapy

the Internet. Chelation therapy involves the intravenous injection of a

and promotional materials for chelation therapy contained such statements

Chelation therapy is a safe, effective, and relatively inexpensive

Every single study of the use of chelation therapy for atherosclerosis

Chelation therapy promotes health by correcting the major underlying

blood flow increases after chelation therapy.

that EDTA chelation therapy is an effective treatment for atherosclerosis,

would prohibit ACAM from representing that EDTA chelation therapy is an

or comparative effectiveness of chelation therapy for any disease of the

in connection with the advertising or promotion of chelation therapy.

Larry Doss, MD, who practices in Ohio, does chelation therapy. He also promotes "Bioactive Cell Complex," a product made from organ cells of young animals, that, when taken by mouth allegedly "congregate at the human counterpart of the organ from which they were taken and "imprint" their vigor and vitality upon like organs in the human body" to give the user vigor; renewed sexual satisfaction, and a more youthful appearance . (This claim is nonsense because any such cells would be digested and not enter the body intact.)

Douglas Hunt, MD,* who practices in Burbank, California and has hosted a radio show. The directory of the American College for Advancement of Medicine (ACAM) lists his specialties as allergy, bariatrics, chelation therapy, hypoglycemia, metabolic medicine, nutrition, preventive medicine, and "yeast syndrome." (ACAM is a professional organization that promotes chelation therapy and many other dubious treatment methods. In1998, the FTC secured a consent agreement barring ACAM from making unsubstantiated advertising claims that chelation therapy is effective against atherosclerosis or any other disease of the circulatory system .)

Ron Kennedy, MD, who operates the Anti-Aging Medical Clinic in Santa Rosa, California, and a large Web site called The Doctor's Medical Library The ACAM directory lists his specialties as chelation therapy, bariatrics, cardiovascular disease, degenerative disease, diabetes, endocrinology, and nutrition.

Gary S. Ross, MD,* practices in San Francisco and teaches nutrition and clinical science at Meiji.College of Oriental Medicine in Berkeley. The ACAM directory lists his specialties as allergy, chelation therapy, degenerative disease, family practice, nutrition, and preventive medicine.

Carol Uebelacker, MD,* who practices in Milwaukee and is listed in the ACAM directory with specialties of allergy, cardiovascular disease, bariatrics, chelation therapy, family practice, and gynecology.

Paul (Pavel) Yutsis, MD,* who operates the Yutsis Center for Integrated Medicine, Brooklyn, New York, where he offers "hyperbaric oxygen therapy, preventive medicine, nutritional therapy, general practice, clinical ecology, pediatrics, and chelation therapy." He is also "Assistant Professor of Medicine" at the Capital University of Integrative Medicine, a nonaccredited school in Washington, D.C., that advocates a wide range of quack practices.

Dennis Harper, DO, who practices in Utah, is listed in the ACAM directory as specializing in allergy, chelation therapy, osteopathic manipulation, and "yeast syndrome."

James R. Privitera, MD, who practices in Covina, California, and is listed in the ACAM directory as specializing in allergy, chelation therapy, metabolic medicine, nutrition. In 1975, he was convicted of conspiring to prescribe and distribute laetrile (a quack cancer remedy) and was sentenced to six months in prison.

Donald C. Thompson, MD, DPh,* a family practitioner in Morristown, Tennessee, whose activities and interest have included pain management, hormones, herbs, exercise, meditation, anti-aging therapies, orthomolecular treatment, chelation therapy, glandulars, homeopathy and psychotherapy.

Medical association settles false advertising charges over promotion of "chelation therapy." FTC news release, Dec 8, 1998.

Chelation therapy is a series of intravenous infusions containing EDTA and various other substances. Proponents claim it is effective against atherosclerosis and many other serious health problems.

However, no controlled trial has shown that chelation therapy can help any of them. Chelation therapy with EDTA is one of several legitimate methods for treating cases of lead poisoning, but the protocol differs from that used inappropriately for other conditions.

To its credit, the AOA has adopted a negative position statement on chelation therapy:

WHEREAS, chelation therapy utilizing calcium disodium edetateis currently labeled by the Food and Drug Administration and recognized by most physicians as medically acceptable only in the management of acute or chronic heavy metal poisoning; now, therefore, be it

RESOLVED, that pending the results of thorough, properly controlled studies, the American Osteopathic Association does not endorse chelation therapy as useful for other than its currently approved and medically accepted uses. Adopted 1985, revised and reaffirmed, 1990, 1995 .

The 1998 member referral list of the American College for Advancement of Medicine (ACAM) , the principal group promoting chelation therapy, identifies about 400 MD members and 121 DO members who list chelation therapy as a specialty. These numbers strongly suggest that the percentage of osteopathic physicians doing chelation therapy is about four or five times as high as the percentage of medical doctors doing it. Curiously, Ronald A. Esper, DO, of Erie, Pennsylvania, who was AOA's president in 1998, is an ACAM member and does chelation therapy.

95% OF DOCTORS THAT PRACTICE CHELATION THERAPY ARE M.D.s. CHELATION THERAPY IS 85-95% EFFECTIVE IN ALL PATIENTS THAT TAKE A FULL COURSE OF THERAPY. WHOEVER THE STUPID MOTHERFUCKER IS THAT MADE THIS WEB PAGE SUCKS DICKS AND DESERVES TO DIE OF THROAT CANCER.

The Illinois corporate database states that the American Board of Chelation therapy qualified for nonprofit status in 1986 but its registration status was revoked in 2004 .

I do not believe they will gain any such recognition because the underlying premises of chelation therapy and their diagnoses of "toxicity" are unsound. Most (if not all) "clinical metal toxicologists" claim that "heavy metal toxicity" is an underlying cause of heart disease, autism, and many other diseases, including cancer. Their favorite test for diagnosing alleged toxicity is a "provoked" urine test for which urine is collected after a chelating agent is administered . Chelation and other methods are then used to "detoxify" the body, which proponents say will enable it to heal whatever disease they claim to treat. Provoked testing is a fraud , and chelation therapy has no rational use against the diseases that "clinical metal toxicologists" claim to treat .

Theodore Rozema, M.D., an ABCMT director who practices in North Carolina, was dismissed from the U.S. Air Force in 1963 following a court marshal proceeding in which he was found guilty of indecent assault of two female officers . In 1978, the North Carolina Medical Board placed him on three years' probation in response to a 1976 felony extortion conviction in Massachusetts . 1984, the North Carolina board charged him with using chelation therapy to treat patients with atherosclerotic heart disease, which the board considered to be improper conduct. This charge, however, was not pursued . In 1986, after he admitted to the State Board of South Carolina that he had presigned prescription blanks, that board suspended his licensed for six weeks and then placed him on indefinite probation . In 1990, after a federal court dismissed Rozema's appeal of the South Carolina board order, the North Carolina board placed him on probation, which he served until 1997.

The ABCMT's secretary John Parks Trowbridge, M.D., who practices in Texas, was charged in 1990 with false advertising in connection with "nonsurgical face lifts", chelation therapy, and cytotoxic testing . After further consideration, however, the Texas Board of Medicine dismissed these charges . In 1998, without admitting fault, Trowbridge signed an agreed order under which the Texas board reprimanded him for using patient testimonials in advertising . Trowbridge has also had tax trouble. In 2003, a tax court ruled that he had improperly failed to pay more than $420,000 in income taxes for 1996 and 1997 by setting up sham trusts and then simply refusing to pay . He was assessed $116,000 in penalties and another $25,000 for frivolously appealing these determinations . He appealed again, but in 2004, the court denied his appeal and sanctioned him $6,000 more for pursuing his frivolous arguments .

Robban Sica, M.D., an ABCMT director who practices in Connecticut, has had legal trouble related to "detoxification." In 2003, the Connecticut Department of Health charged her with improperly using chelation therapy to treat cardiovascular disease, failing to obtain adequate consent for such treatment, and failing to properly manage patients whom she said were suffering from heavy metal toxicity. In February 2005, she signed a consent order under which she agreed to (a) stop using a provoked test to diagnose heavy metal toxicity, and (b) use a patient consent form which states that chelation therapy has not been scientifically substantiated .

The ABCMT's chairman, Rashid A. Buttar, DO, was sued by the U.S. Justice Department in 1997 for failing to repay a $113,783.59 military scholarship obligation. In 1999, the case was settled with a consent agreement under which he agreed to pay $115,500 . Buttar is currently facing two complaints filed by the North Carolina Medical Board. One accuses him of charging four cancer patients exorbitant fees for worthless tests and treatments . The other accuses him of mistreating four patients whom he falsely diagnosed with mercury toxicity . During a hearing held in April 2008 related to an earlier version of the first complaint, Buttar indicated that nearly all the patients he sees are diagnosed with heavy metal toxicity and receive chelation therapy, and an ABCMT board advisor who testified in his defense, John L. Wilson, Jr., M.D., stated that he had administered well over 200,000 intravenous infusions. . Wilson is also a board member of Moms Against Mercury, a group that is trying to get the use of dental amalgam banned.

Green S. Chelation therapy: Unproven claims and unsound theories. Quackwatch, July 24, 2007.

42. At the time Defendants administered chelation therapy to HB, they knew or should have known that the American Medical Association had issued a policy statement that states that "if chelation therapy is to be considered a useful medical treatment for anything other than heavy metal poisoning, hyperglycemia or digitalis toxicity, it is the responsibility of its proponents to conduct properly controlled scientific studies, to adhere to FDA guidelines for drug investigation, and to disseminate study results in the usually accepted standards."

43. Defendants heavily advertised chelation therapy as a "cure" for autism and performed chelation therapy on HB at an extremely high rate of profit, but did not conduct properly controlled scientific studies, adhere to FDA guidelines for drug investigation, or disseminate study results in the usually accepted standards.

44. Defendants failed to follow protocols that are recommended for those conducting trials of chelation therapy in autistic children. Defendants failed to conduct challenge doses in order to evaluate the likely effectiveness of chelation therapy, and once therapy was initiated, failed to monitor the results in order to evaluate the propriety of continued treatment.

45. Defendants represented that there was "no downside" to the chelation therapy they performed on HB. Defendants represented to Plaintiffs that the treatment was risk free. In fact, chelation therapy presents significant risks of which Plaintiffs were not informed.

46. One of the risks of chelation therapy is the possibility that patients undergoing chelation therapy may contract neutropenia, a blood condition seen most commonly in cancer patients undergoing chemotherapy. After undergoing the chelation treatment recommended by Defendants, HB was diagnosed with neutropenia.

Chelation therapy is a series of intravenous infusions containing EDTA and various other substances. Proponents claim it is effective against atherosclerosis and many other serious health problems. However, no controlled trial has shown that chelation therapy can help any of them. Chelation therapy with EDTA is one of several legitimate methods for treating cases of lead poisoning, but the protocol differs from that used inappropriately for other conditions.

WHEREAS, chelation therapy utilizing calcium disodium edetateis currently labeled by the Food and Drug Administration and recognized by most physicians as medically acceptable only in the management of acute or chronic heavy metal poisoning; now, therefore, be it

The 1998 member referral list of the American College for Advancement of Medicine (ACAM) , the principal group promoting chelation therapy, identifies about 400 MD members and 121 DO members who list chelation therapy as a specialty.

These numbers strongly suggest that the percentage of osteopathic physicians doing chelation therapy is about four or five times as high as the percentage of medical doctors doing it. Curiously, AOA President Ronald A. Esper, DO, of Erie, Pennsylvania, is an ACAM member and does chelation therapy.

Evers then moved to Montgomery, Alabama, where, despite FDA efforts, a judge allowed him to continue doing chelation therapy.

In 1980, he opened the ninety-bed Evers Health Center in Cottonwood, Alabama. His letter to prospective patients stated that his practice was "limited to the diagnosis and treatment of chronic degenerative diseases by the nutritional, non-toxic, metabolic method including chelation therapy" and offered "special regimes of treatment" for arthritis, amyotrophic lateral sclerosis, multiple sclerosis, diabetes, cancer, Parkinson's disease, and other diseases. According to the clinic brochure, a patient's typical day would include a visit with Dr. Evers, spinal manipulation by his chiropractic associate, chelation therapy (three hours), and other therapies such as hyperbaric oxygen and colonic irrigation.

Michael Gerber, M.D., had his California medical license revoked after hearings before the California Board of Medical Quality Assurance in which he was accused in 1984 of improperly administering to patients. One patient was a fifty-six-year-old woman with treatable cancer who had allegedly died as a result of Gerber's neglect while he treated her with herbs, enzymes, coffee enemas, and chelation therapy.

Garry Gordon, M.D., has been president of the American Academy of Medical Preventics (currently called the American College of Advancement in Medicine), a group of doctors who do chelation therapy. He has also been medical director and board chairman of Mineralab (a large commercial hair analysis laboratory) and director of a subsidiary that sold questionable nutritional products.

Although he maintained that ADS was a "nutritional supplement," analysis showed it to be 99.4 percent water and a brownish sludge composed mainly of coliform bacteria (the same bacteria found in human feces). Halstead, who operated the Halstead Preventive Medicine Clinic in Colton, California, has been a leading promoter of laetrile, chelation therapy, and many other questionable practices.

So called "chelation therapy" is a case in point.

Some practitioners believe that they can use Magnesium Disodium EDTA or Disodium EDTA for allegedly removing calcium from atheromatous plaques which line diseased arteries. Atheromata(pl. of atheroma) are pathological collections of cells deep in the walls of arteries which contain various forms of cholesterol. Occasionally, some of these atheromata calcify. The "chelation therapists" mistakenly believe that treatment with Magnesium Disodium EDTA will remove this calcium and remove the atheromata. This belief is unsupported by scientific theory, scientific fact, and practical experience. A number of reviews on the topic of chelation therapy for treating atherosclerosis (the presence of atheromata) in the lining of arteries of major importance (aorta, coronary arteries, and major arteries to the extremities) has shown that this therapy is not only ineffective, but may also cause damage to the walls of arteries and actually cause atheromata to appear. The use of any form of EDTA for treatment of atheromata or atherosclerosis is not approved by the U.S. FDA.

At the very best, even the proponents of chelation therapy for atherosclerosis therapy admit that this concept is experimental.

Where chelation therapy advocates have suggested any success it has been with the ability of people with severe peripheral vascular disease of the legs to improve their walking distances slightly after therapy. Even these claims are controversial, and there are data to suggest that these claims, largely supported by only subjective data, are specious.

At the very best, chelation therapy with EDTA for treatment of atheromatous cardiovascular disease, is unproven and experimental.

Since their consent decree with the FTC, however, ACAM has apparently developed a scheme to make it appear that their members are participating in an "experiment" where EDTA therapy is "tested" "clinically". This alleged "study" has some of the trappings of a clinical trial, but none of the substance. It appears to be, in my opinion, a pseudoscientific babble of imprecise, unclear activities for its members to present to unsuspecting, often elderly patients who have real cardiovascular diseases. I have personally reviewed multiple cases of patients who were directed away from potentially life-saving, or life-prolonging, conventional, evidence-supported treatments for cardiovascular disease to chelation therapy which provided no benefit other than to enrich the practitioner who promoted and performed it. I have personally seen several patients maimed and several deaths by such careless practitioners.

Chelation therapy is only one of many such areas of illegitimate human experimentation. I have seen the elderly (and others) regularly victimized in schemes for "cancer cures", treating Amyotrophic Lateral Sclerosis, alleged heavy metal poisoning, heart disease, and neurodegenerative disorders. The since delicensed Colorado dentist, Hal Huggins, emptied the bank accounts of an elderly Kansas farm couple after convincing them that he could treat the wife's breast cancer and her husband's ALS. The husband nearly died during treatment when he aspirated unnecessary pills which were to allegedly "detoxify" him from his dental fillings.

32. From in or around December 1997 to in or around March 2002, Scott Rulon Werner, M.D., defendant herein, knowingly and willfully devised and intended to devise a scheme and artifice to defraud public and private health care benefit programs and to obtain money from such programs by means of false and fraudulent pretenses, representation, and omissions, in that the defendant submitted false claims representing that he had rendered IV therapy services for beneficiaries, when in truth and fact the defendant rendered chelation therapy services for beneficiaries, resulting in payments from health care benefit programs to which the defendant was not entitled.

33. It was part of the artifice and scheme to defraud that the defendant recommended and performed chelation therapy services for beneficiaries who presented with various illnesses and symptoms other than those associated with heavy metal toxicity.

35. It was further part of the artifice and scheme to defraud that the above claims were submitted to reflect falsely that a beneficiary had received IV therapy services when in truth and fact the beneficiary had received chelation therapy services.

The information contained in the HCFA-1500 claims prepared at the defendant's direction and control failed to disclose any information which would have put the public and private health care benefit programs on notice that the defendant has performed chelation therapy services for their respective beneficiaries.

37. During in and around 199, the defendant, o clinic personnel acting at the defendant's direction and control, began altering patient chart entries from "chelation therapy" to "IV therapy." The changes were made in different ways, including among others: (a)placing a sticker containing a false chart entry for "IV" over a chart entry for "chelation" therapy; and (b) revising the chart entry template on the clinic's computer from "chelation" therapy services to "IV" therapy services. The foregoing protocol was either in effect or implemented shortly after the clinic was served on or around September 20, 1999 with a Medicaid subpoena for records relating to specific beneficiaries .

In December 2001, the Wisconsin Medical Examining Board charged Eleazar M. Kadile, M.D., of Green Bay, Wisconsin, with ten counts of unprofessional conduct. The charges included false advertising; failure to give adequate informed consent; failure to keep adequate medical records; obtaining payment by fraud and deceit; and falsely representing that patients were suffering from toxic conditions. in November 2003, the case was settled with a consent agreement (stipulation) under which Kadile agreed to abide by a Final Decision and Order that requires him to (a) implement a strict mandatory disclosure procedure for patients contemplating chelation therapy; (b) undergo an evaluation to determine his fitness to continue practicing medicine, (c) fulfill certain educational requirements; (d) have his practice monitored for at least two years by an independent expert approved by the Board; and (e) pay costs related to the disciplinary process for an amount determined by the Board.

ACID (EDTA) CHELATION THERAPY

Malignancies, diseases, illnesses or physical conditions diagnosed for medical treatment by EDTA chelation therapy (list all):

(c) that EDTA chelation therapy has NOT been established through controlled trials to be effective for the treatment of circulatory diseases, specifically including atherosclerosis, hardening of the arteries (arteriosclerosis), vascular insufficiency, diabetes or any other condition beyond those mentioned in (a);

(f) that neither the American Medical Association, the American Osteopathic Association, the American College of Cardiology, the American Heart Association, the American College of Physicians, or the American Academy of Family Physicians, recommends the use of EDTA chelation therapy for the treatment of any human disease, illness, malady or physical condition other than those for which it is labeled;

(g) That therapy with EDTA chelation may not be begun until three days have expired after the date of my execution of this informed consent form, unless I have furnished records showing that I am presently receiving chelation therapy from another physician.

Chelation therapy involves the administration of a substance that combines with metallic chemicals to increase their excretion by the kidneys. The most common form is a series of intravenous infusions that contain a chelating agent (EDTA) and various other substances. Doctors who offer chelation therapy as part of their everyday practice typically claim that it is effective against autism, heart disease and many other conditions for which it has no proven effectiveness or plausible rationale .

The "Urine Toxic Metals Test" is used to trick people into thinking that they have lead or mercury poisoning. The heart of the process is "provoked" testing in which a chelating agent is given before the specimen is obtained. This artificially raises the levels of lead, mercury, and/or other heavy metals in the urine. The test report, a copy of which is given to the patient, states that its "reference values" are for non-provoked specimens. However, if a test level exceeds the reference values—which it usually will—it is reported as "elevated" even though it should be considered insignificant. The patient is then advised to undergo "detoxification" with chelation therapy, other intravenous treatments, dietary supplements, or whatever else the practitioner happens to sell . This advice is very, very, very wrong. No diagnosis of lead or mercury toxicity should be made unless the patient has symptoms of heavy metal poisoning as well as a much higher non-provoked blood level. And even if the level is elevated—as might occur in an unsafe workplace or by eating lead-containing paint—all that is usually needed is to remove further exposure.

Chelation therapy occasionally leads to electrolyte imbalances and organ damage. The biggest danger arises from the fact that it is marketed as a substitute for coronary bypass surgery. People who use chelation instead of necessary medical or surgical care put their life at risk.

Green S. Chelation therapy: Unproven claims and unsound theories. Quackwatch, July 24, 2007.

15. During the period of January 1, 2002 through the date of this Statement of Charges, respondent has administered and/or prescribed EDTA chelation therapy for coronary and/or vascular diseases and for diagnoses of various metal toxins in approximately 40 patients.

Chelation therapy is a series of intravenous infusions containing EDTA and various other substances. It is falsely claimed to be effective against cardiovascular disease and many other diseases and conditions. Chelation has valid use in some cases of heavy metal poisoning. However, chelationists often diagnose it in patients with no history of toxic exposure and use treatment protocols that differ from standard protocols .

In February 2005, Sica and the Connecticut licensing authorities signed a settlement under which she agreed to: (a) serve a year of probation, (b) stop using DMPS as a chelating agent, (c) stop using a provoked test to diagnose heavy metal toxicity, (d) use a patient consent form which states that chelation therapy has not been scientifically substantiated, and (e) have her practice monitored by an independent consultant. The agreement also contained stringent recordkeeping and reporting requirements and a provision that Sica could not own shares or serve as an officer of any professional corporation or other form of medical practice in which she does not render a substantial amount of patient care .

In addition to chelation therapy, Sica offers other questionable services, the most notable of which is "electrodermal screening" with the Listen System, which Sica says can "help identify patterns of environmental sensitivities." However, the device merely measures skin resistance to a low-level electric current. According to a proponent's patent application:

Barrett S. Chelation therapy and insurance fraud. Quackwatch, May 11, 2000.

Another clinical trial of chelation therapy began in 2003. The study—called the Trial to Assess Chelation Therapy (TACT)—is funded by the National Institutes of Health with an estimated completion date of July 2009. The chelation is supposed to be administered at more than 100 facilities, many of whose operators have been in serious trouble and should not be regarded as trustworthy. In September 2007, the Government's clinical trial Web site indicated that most sites had not finished recruiting patients, so it is not clear whether this study will be completed. Meanwhile, of course, it is trumpeted as evidence that chelation works and that participating doctors are competent researchers.

In 1995, the Georgia Board of Medical Examiners charged Edelson with (a) failing to document an initial physical examination in a patient's chart and failing to have adequate progress noted in another patient's chart, which constituted failure to conform to minimal an acceptable standards of prevailing medical practice; and (b) failing to keep adequate records of narcotic drugs prescribed for himself and members of his family. The case was settled with a consent agreement under which he was fined $5,000 and placed on two years' probation with a condition that he not perform chelation therapy except in cases of heavy metal poisoning, unless done as part of an approved clinical trial . A few months later, based on the Georgia action, New York State issued a censure and reprimand and placed him on probation . When Georgia's probationary period ended, he was no longer restricted. However, in 2004, the Georgia board reprimanded him again, ordered a fine, and placed him on indefinite probation.

After receiving the test results, Edelson recommended that the boy undergo a lengthy and expensive course of chelation therapy and intravenous gamma globulin treatment, followed by "detoxification" with dietary supplements.

The treatments were difficult and painful, involving multiple intravenous treatment (chelation therapy) with frequent needle changes due to technician errors. The nutritional regimen included about 50 pills and capsules a day, which often caused the boy to vomit.

Barrett S. Misconceptions about immunization: Thimerosal causes autism; chelation therapy can cure it. Quackwatch, April 20, 2002.

Green S. Chelation therapy: Unproven claims and unsound theories. Quackwatch, revised March 28, 2002.

Green Bay Press-Gazette, a general circulation newspaper, an advertisement which stated that a "typical" patient treated with chelation therapy reported that his coronary artery blockage was halved by respondent's chelation therapy, and which quoted a patient as saying "I have no doubt that chelation therapy is an effective way to not only combat, but reverse some of the effects of atherosclerosis." The Board finds that there are not sufficient data to support these representations, and they may therefore be misleading.

6. In resolution of this matter, the Board makes no findings concerning the efficacy of EDTA chelation therapy for vascular disease at this time, but finds that respondent's records of the patients whose charts were examined were deficient in other respects, as noted above, from which the Board infers "negligence" as defined by law.

Respondent may offer chelation therapy only if the patient signs the form which is attached to this Order as REQUIRED DISCLOSURE FOR ETHYLENEDIAMINETETRAACETIC ACID (EDTA) CHELATION THERAPY. Respondent shall not in any way attempt to defeat or minimize the message of the approved disclosure forms with other documents or oral statements. Respondent shall comply with ch.

Before chelation therapy is administered, and contingent upon the consent of the patient, the patient's primary care physician or a relevant specialist (e.g. a cardiologist) shall be informed, and all legend components of the therapy shall be disclosed.

WebMD Health contains many staff-generated articles that promote nonsensical "alternative" methods, including homeopathic treatment of earaches and cancer. Colonic irrigation is senseless and has killed people. But instead of telling the truth, an article states that it "has yet to gain the endorsement of any mainstream medical organization." WebMD also includes an extensive collection of articles from Healthwise that fail to adequately criticize what they describe. Its chelation therapy article, for example, states that, "Chelation therapy has also been used by some health professionals to treat atherosclerosis and/or coronary artery disease, although there is inadequate current scientific evidence that proves this treatment is effective. Some believe that EDTA binds with calcium deposits (the part of plaque that obstructs the flow of blood to the heart) in the arteries and then the calcium deposits are 'cleaned out' of the arteries by the EDTA, reducing the risk of heart problems. This treatment is controversial, and research results have been inconsistent." An honest presentation would say there is no logical reason to believe EDTA chelation is helpful against cardiovascular problems and that the "inconsistent results" consist of poorly designed studies that claimed benefit and well-designed studies that found none.