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METAL CHALLENGE PROTOCOL

Description and Consent Forms

DESCRIPTION

The presence or absence of disease, in relation to heavy metals, is related to:

· The number of toxic metals present in our cells · The concentration of each metal present
· Concomitant medical conditions or illnesses · One’s nutritional status
· The coexistence of organic pollutants that synergize with metal toxins
· One’s genomic detoxification and antioxidant defense abilities

Genetic testing (see Methyl Cycle Genomics on the heartfixer.com website) and nutritional testing (Genova Labs NutrEval) is available to you. We will look for concomitant medical conditions as part of your standard medical evaluation and laboratory testing.

Measuring the content of toxic metals in your cells is more difficult. These metals bind tightly to proteins and other structures; thus, the concentration of metals in our cells is not in predictable equilibrium with the concentration
of heavy metals in our blood or other body fluids. Toxic metal blood levels reflect, as a general rule, recent exposure as opposed to intracellular or total body burden of the metal in question. Blood levels are thus useful only
when monitoring for toxicity in the industrial setting. A tissue metal level would be ideal (i.e. kidney or liver biopsy), but is obviously not practical. Red blood cells remain in our circulation for three months. We can use red
blood cell levels as a rough indicator of one's nutritional mineral status, but the red cell toxic metal level best reflects exposure only over the preceding three months, and is not a good measure of tissue burden. Hair metal
levels reflect only what the body can excrete in the hair, and do not correlate well with other determinations. The best clinical measure of tissue metal burden, and the one best supported in the medical literature, is the
provocative challenge. Here a metal binding or "chelating" agent is administered, followed by an analysis of the level of heavy metals present in a subsequent timed urine sample. The water-soluble chelating agent binds to
the heavy metal, and then ferries it out through the kidney into the urine.

In therapeutic chelation, Magnesium EDTA, infused slowly over 3 hours, is typically used to remove toxic metals such as Lead and Cadmium. DMSA (oral) is used when we are targeting Mercury.

While Mother Nature did not design us to deal with toxic metals, we do try. 90% of endogenous metal detoxification involves the excretion of metals by the liver into the intestines and out into the stool. Unfortunately, metals
flushed out through the liver into the intestines can be reabsorbed, a process known as "enterohepatic recirculation". EDTA-metal complexes can also be flushed out via the liver into the intestine. If our GI tracts are sluggish,
the EDTA-metal bond may break, with reabsorption of the metals. However, if chelating agents are present in the intestines (i.e. EDTA for Lead or DMSA for Mercury) then re-uptake of the toxic metal will be blunted, leading
to improved clearance of toxic metals from the body. Thus, we always recommend concomitant oral chelation when we give you an IV chelator.

While we in the U.S. have been administering EDTA as a Magnesium EDTA complex, typically over 3 hours (the form of EDTA used in the Trial to Assess Chelation Therapy, in which Dr. Roberts was a Principle Investigator) physicians in Europe have used Calcium EDTA, which is administered as a slow IV push. The more rapid administration of the Calcium form of EDTA leads to a higher blood EDTA level, and thus to a more potent chelating
effect. Dr. Blummer of Zurich has reported quite favorable results with his use of Calcium-EDTA in thousands of patients over a 30-year time span. We have been using Calcium EDTA for approximately 15 years, as an
alternative to Magnesium EDTA as a clinical chelator, and within the diagnostic metal challenge protocol, and have not observed any side-effects unique to this form of EDTA chelation. The Trial to Assess Chelation Therapy demonstrated the safety and efficacy of Magnesium EDTA chelation therapy in heart attack survivors already on standard pharmaceutical therapy (18-40% reduction in five-year cardiovascular event rate).

To further improve the ability of Calcium EDTA and oral DMSA to remove toxic metals, we will concomitantly place you on a program of oral chelation, using Med Five which contains (enteric coated) EDTA and phosphatidylcholine. Chelation therapy may remove nutritional as well as toxic metals, so we recommend that you take a broad-spectrum vitamin and mineral supplement while undergoing Chelation Therapy. Pre-treatment
with a vitamin and mineral supplement is not mandatory before a single dose of chelation, given as part of a diagnostic challenge. The challenge protocol is given below.

1. Avoid fish and shellfish the week preceding your challenge study (high in Mercury).
2. Take Med Five, one tab twice daily, 2 days before, the day of, and over the next 2 days.
3. Do not take any mineral supplements on the morning of your challenge study.
4. Empty your bladder before receiving the IV Calcium EDTA and oral Vitamin C and DMSA; then collect all urine over the next 6 hours (and drink plenty of water to help flush the heavy metals out). Ideally, refrigerate the
urine specimen until it is shipped to Doctors Data, and keep the container capped (Mercury can evaporate off). Remember that heavy metals are heavy; be sure to shake up the collection jug before pouring off the portion to be
measured into the test tube provided.
5. If you elect to undergo a program of physician assisted elective heavy metal detoxification, from time to time we can repeat the challenge study, and compare against the baseline values.

Estimated Costs:
1. Triple challenge IV and chelating agents - $145
2. 6-hour urine toxic assessment - $60.00

For additional information, please review our UTube presentations on EDTA Chelation Therapy and the Health Effects of Mercury. The heartfixer.com website contains additional information about metal detoxification. For
a monograph on Lead, please click the Medical Topics section on home page of our heartfixer.com website.

James C. Roberts MD FACC FAARFM 1/1/20

CONSENT FORM

The rationale for provocative challenge testing to estimate one’s body burden of toxic metals is presented within the Metal Challenge Protocol document that you have received. Briefly, you will receive oral and IV EDTA, aiming to bind and remove Lead, Cadmium, and several other metals, oral DMSA to bind and remove Mercury, and oral Vitamin C. Urine will be collected over the following 6 hours, and a portion will be sent to Doctor’s Data in Chicago for metal content analysis. We feel that the provoked challenge is the best clinically available measure of body metal burden.

Most patients feel nothing during the study or over the preceding two days, when they are taking Med Five. Some individuals experience fatigue, as toxic metals are being mobilized. There is always the potential for an allergic reaction, and for this reason we ask you to remain in the office for 30 minutes following IV administration.

The mobilized toxic metals will leave your body via the kidneys, and thus we need to assess kidney function (serum creatinine level within the preceding 4-6 months) before you undergo metal challenge testing. Please maintain oral fluid intake before and during the study.

Calcium EDTA and DMSA are FDA approved drugs. Please remember, just because an agent is FDA approved does not mean that side effects cannot occur. The triple challenge protocol involves the administration of 1000 mg of Calcium EDTA IV, 500 mg of oral DMSA, 1000 mg of oral Vitamin C, and oral EDTA (Med Five).

Dr. Roberts has a great deal of experience with these agents and with metal detoxification in general, and feels that the information obtained from provocative challenge testing is worth the small risk associated with the procedure. With the injection there may be a slight drop in blood pressure; thus, we administer the Calcium EDTA slowly. Transient itching and a somewhat "down mood" following the injection are not uncommon. "Stirring up" mercury and other toxic metals from their storage sites within the body and releasing them into the circulation for excretion via the kidneys or GI tract has the possibility of transiently worsening any toxic metal related symptom in a sensitive individual.

I acknowledge that the challenge protocol has been explained to me, including the rationale for testing. I have reviewed the Metal Challenge Protocol document. After receiving the chelating agents, I agree to drink several glasses of water and to take additional Vitamin C to enhance the body's ability to eliminate the toxin through the kidneys and GI tract, and thereby lessen any symptoms that may from the administration of Calcium EDTA and DMSA.

I acknowledge that my insurer will not cover the cost of the triple challenge study or the urine metal analysis carried out by Doctor’s Data. The charge from the office for Calcium EDTA administration and oral DMSA, Vitamin C, and Med Five will be $145. The lab charge from Doctor’s Data will be $60.

While randomized, double blind, placebo controlled clinical trials support the safety and efficacy of EDTA chelation therapy in the treatment of chronic kidney and coronary disease (Dr. Roberts was a principal investigator in the Trial to Assess Chelation Therapy), the majority of US physicians do not utilize Chelation Therapy and Chelation Therapy is not FDA approved in the treatment of these conditions. I thus understand that Provocative Challenge Testing and Chelation Therapy is not considered as the Standard of Care by Medicare, Major Insurers, FDA, and the American College of Cardiology.

I have read the above information and the Metal Challenge Protocol document. I have had the opportunity to ask questions. I understand the rationale and risks of the Metal Challenge Provocation test and consent to have this study carried out.

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Patient Signature Date

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Witness Date