Chelation Therapy Consent Form

In February 2005, Robban A. Sica, M.D., who operates the Center for the Healing Arts in Orange, Connecticut, settled charges related to her care of about about 40 patients. In 2003, she was charged with improperly using chelation therapy to treat cardiovascular disease, failing to obtain adequate consent for such treatment, and failing to properly manage many of these patients whom she said were suffering from heavy metal toxicity. Under the consent agreement 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 this 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 contains 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. Quackwatch has additional information on Sica's background .

PATIENT'S CONSENT FOR ETHYLINEDIAMINETETRACETIC
ACID (EDTA) CHELATION

PATIENT IS TO READ AND INITIAL EACH PARAGRAPH
AND SIGN AT THE BOTTOM

PATIENT'S NAME: __________________________________________

ADDRESS: __________________________________________________

_____________________________________________________________

AGE: ________ SEX: Male  Female

NAME AND ADDRESS OF PHYSICIAN

_____________________________________________________________

_____________________________________________________________

Malignancy, disease, illness or physical condition:

_____________________________________________________________

My physician has explained to me and I fully understand that EDTA chelation may or may not alleviate or cure the condition(s) for which it is offered and further that:

_____ (a) EDTA is administered either as a Calcium Disodium EDTA or Disodium EDTA.

_____ (b) The United States Food and Drug Administration ("FDA") has evaluated Calcium Disodium EDTA and approved its use only for the treatment of lead toxicity.

_____ (c)The United States Food and Drug Administration ("FDA") has evaluated Disodium EDTA and approved its use only for the treatment of hypercalcemia and digitalis toxicity. The FDA required label specifically states that Disodium EDTA is not indicated for treatment of systemic arteriosclerosis due to aging.

_____ (d) The FDA reviews the safety and effectiveness of particular uses of drugs but does not forbid physicians to use approved medications for off-label use.

_____ (e) No scientifically controlled studies (double-blind, randomized, placebo controlled trials) show that blood concentrations of lead less than 10 micrograms per deciliter cause any symptomatic illnesses or conditions. No scientifically controlled studies show that Calcium Disodium EDTA chelation of lead at blood concentrations less than 10 micrograms per deciliter will improve any symptom; several scientifically controlled studies show that chelation of lead at these concentrations does not improve mental or neurological functioning.

_____ (f) No scientifically controlled studies show that EDTA chelation is effective for the treatment of circulatory diseases, specifically including atherosclerosis, hardening of the arteries, vascular insufficiency or diabetes. Three scientifically controlled trials have concluded that Disodium EDTA treated these conditions no more effectively than placebo. The National Institutes of Health is presently conducting a nationwide study of the effectiveness of Disodium EDTA to benefit patients who have already suffered a heart attack (known as the Trial To Assess Chelation Therapy, abbreviated TACT).

_____ (g) There are no scientific studies that show that any chelator successfully removes heavy metals from the brain, and numerous scientific studies that show that chelators do not remove heavy metals from the brain. There are no scientific studies that show that chelation of heavy metals improves the symptoms of neurological dysfunction except in patients with extremely high levels of metal concentration. Scientific studies show that EDTA does not chelate organic compounds of mercury, such as methylmercury, which is the most common form of mercury in the human body.

_____ (h) The Connecticut Department of Public Health has determined that there is published scientific evidence that the use of EDTA chelation therapy may be harmful to a patient's health in that (a) patients may forego the use of medical treatments and drugs that controlled trials have shown are beneficial, and (b) that there have been reports of adverse effects from the use of Disodium EDTA including death, emergency hospitalization, and kidney damage. In addition, the Centers For Medicare and Medicaid Services and the National Institutes of Health consider the use of EDTA chelation experimental. The Connecticut Department of Public Health warns that medical ethics typically do not permit a physician to use an experimental medication except in an approved, supervised experimental study, and that such studies generally do not charge a fee to participating patients. The Connecticut Department of Public Health notes that the United States Federal Trade Commission has issued an order to the American College For Advancement In Medicine (“ACAM”) that advertising that EDTA chelation effectively treats atherosclerosis is misleading until such time as controlled studies demonstrate its effectiveness. Therefore the Connecticut Department of Public Health strongly recommends that patients seek the advice of an internal medicine specialist or other specialist certified by a certification board recognized by the American Board of Medical Specialties for the condition being treated with EDTA chelation. The American Board of Medical Specialties does not recognize the American Board of Chelation Therapists, the American Board of Clinical Metal Toxicology, the American Board of Chelation Therapy, and the Board Of Medical Toxicology.

_____ (i) Neither the American Medical Association, the American Osteopathic Association, the American College of Cardiology, the American Heart Association nor any other board or medical association that is recognized by the American Board Of Medical Specialties recommends the use of Calcium Disodium EDTA chelation for the treatment of any human disease, illness, malady or physical condition other than lead poisoning nor recommends the use of Disodium EDTA for the treatment of any human disease, illness, malady or physical condition other than hypercalcemia and digitalis toxicity;

_____ (j) The federal government, including Medicare and Medicaid, and most insurance companies do not pay for or reimburse for Disodium EDTA chelation for atherosclerosis or other cardiovascular illness.

_____ (k) My doctor will not begin Disodium EDTA chelation until three working days have expired after the date of my execution of this informed consent form;

_____ (l) My doctor will not begin Disodium EDTA therapy until it has been established by appropriate blood and urine tests that my kidney function is adequate. I understand that periodically I will be required to provide blood and/or urine samples to monitor my kidney function during the course of treatment, and that my doctor will monitor the effect of the EDTA on other conditions such as diabetes by performing tests that may require me to provide blood or urine.

_____ (m) I may withdraw from EDTA therapy at any time

_____ (n) I have received a copy of the FDA approved product insert for Calcium Disodium EDTA or Disodium EDTA.

______________________________________________
Physician

Date ________________________

I HAVE READ AND UNDERSTAND THE ABOVE. I HEREBY ELECT TO UNDERGO EDTA CHELATION UNDER THE PROTOCOL RECOMMENDED BY THE AMERICAN COLLEGE FOR THE ADVANCEMENT IN MEDICINE (ACAM).

______________________________________________
Patient

Date ________________________

 

 

This page was posted on February 19, 2005.

Links to Recommended Companies