New Evidence Supports Chelation Therapy – Letter to the Irish Medical Times

Dear Editor,

I found the commentaries (Irish Medical Times, 6.12.13) by Dr. Neville Wilson and Mr. Serif Sultan on the recent cholesterol guidelines, presented at the American Heart Association (AHA) 2003 Scientific Sessions, most informative.

Also presented at that same meeting was a report by Dr. Esteban Escolar, described by Medscape as ‘extraordinary’ chelation effects discovered in patients with diabetes.

This was a sub-study of patients with diabetes enrolled in the previously reported TACT study (The Trial to Assess Chelation Therapy) which found a highly significant 15% absolute decrease in risk of the primary composite endpoint among diabetic patients in the chelation arm compared with the patients treated with the placebo infusions

.

When they broke the composite down to look at their secondary endpoints, they found that they had about a 40% reduction in total mortality, a 40% reduction in recurrent MI, and about a 50% reduction in mortality in the patients with diabetes.

In the TACT trial patients who were randomised to a regimen involving up to 40 separate three hour infusions of a chelation solution (EDTA plus a vitamin combination) experienced an 18% drop in the trials primary endpoint (all/cause death, re-infarction, stroke, or hospitalistaion for angina) compared with patients randomised to a placebo infusion. All patients in the TACT study were aged 50 years or older and had had a prior MI.

Details of this study can be found on Medscape, and were also published in ‘Circulation: Cardiovascular and Quality Outcomes’.

Yours sincerely,

Dr. Sean Dunphy,

Cork Road Medical Clinic,

Carrigaline

Co. Cork

https://dunphymedicalcarrigaline.com/

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Report on the Proceedings of a Summit on New Directions for Chelation Therapy, published in Townsend Letter

From March 13 to 15, 2013, the International College of Integrative Medicine (ICIM) held a summit meeting about what should be accomplished next, now that EDTA chelation therapy has been supported as a useful treatment for vascular disease by the Trial to Assess Chelation Therapy (TACT). Experts from around the world were invited. This article is a summary of the conclusions and recommendations of this gathering. Key presentations were given by Drs. John Trowbridge, Efrain Olszewer, and Eleonore Blaurock-Busch. Representatives from the US, Canada, Indonesia, Brazil, Denmark, the Netherlands, Germany, Ecuador, and New Zealand participated, as well as the attendees for the Advanced Metals Workshop that was part of the spring meeting of ICIM. Recordings of the lectures are available from icimed.com.

Background
EDTA has been used as a treatment for vascular disease since Norman Clarke Jr.’s work in 1952. For a time line of the many studies that have supported its effectiveness, see chelation.me. In 1981, the American Medical Association (AMA) challenged the proponents of chelation therapy to produce a large-scale, randomized, controlled, clinical trial to prove its safety and effectiveness. The members of the American College of Advancement in Medicine (ACAM), led by president Ross Gordon, collaborated with Walter Reed Hospital to begin such a study for treatment of peripheral vascular disease in 1987. Unfortunately, the first Gulf War took the investigators away from the study, and it was not completed. In 1999, Congressman Dan Burton, chair of the Committee on Oversight, held a hearing bringing together the head of the Heart, Lung, and Blood section of the National Institutes of Health and several physicians who testified about their experiences with chelation. NIH subsequently called for proposals, and eventually TACT was funded, with Gervasio Lamas, MD, as chief investigator.

TACT was unique in that it combined university research cardiologists and experienced chelation specialists with private offices. 134 sites from the US and Canada participated in the randomized, placebo-controlled, double-blind, clinical trial. TACT continued for 7 years and included 1708 patients with documented previous heart attacks who continued to receive evidence-based therapy. The primary end point was a composite of new cardiac events to include death, heart attack, stroke, hospitalization for unstable angina, and need for revascularization surgery. TACT showed that the therapy was unquestionably safe, and the group treated with chelation therapy had fewer cardiac events, which was statistically significant. The results were announced by Lamas at the American Heart Association meeting on November 4, 2012, in Los Angeles. (Publication of the results occurred after the summit in JAMA. March 27, 2013;309([12]):1241–1250). The authors called for further studies to confirm the results and explore the mechanisms of action.

Where We Stand Now, According to the Summit
1.  TACT conclusively showed that chelation therapy used according to the recommended protocol is safe.

2.  TACT and the many other studies that preceded it support the use of chelation therapy as an option for patients with vascular disease, especially for those who also have diabetes and those with a history of anterior wall myocardial infarction.

3.  There is not yet enough evidence to state that chelation therapy should be given to all cardiac patients. More studies need to be done. A duplication of TACT would be ideal, as long as it included heavy metal testing. However, another $30 million to repeat the study might be difficult to find.

4.  Strong consideration should be given to doing a challenge test for heavy metals (especially lead) for all patients with vascular disease. If high levels are found, the patients should be treated with chelating agents.

5.  Regulatory agencies, such as medical boards, should immediately stop harassing physicians who offer chelation therapy to their patients who give appropriate informed consent. Physicians who offer chelation therapy have accomplished exactly what the AMA asked them to do in 1981 to justify its use.

6.  Most physicians who offer chelation therapy are happy to serve as consultants for placebo-controlled RCTs, but are uncomfortable with the ethics of giving placebos to patients who have come to them for help. Certainly, patients should not be asked to pay to receive placebos, especially for a potentially life-threatening illness. Physicians who provide chelation are almost always convinced that in their experience the therapy is very effective.

7.  Most chelation doctors believe that their primary goals of showing efficacy and safety with a RCT have been accomplished with TACT. Gaining FDA approval of EDTA for use in vascular disease is secondary, and they encourage qualified investigators to move in that direction.

Recommendations of the Summit
1.  More research should indeed be done on metal toxicity, free radical pathology, and various diseases that have been linked to free radical pathology, especially vascular disease.

2.  Chelation doctors do not have the resources to fund or carry out clinical trials, but they do have the expertise to help plan them.

3.  The conditions that are most likely to show benefit with chelation treatment and thus should have the greatest research priority are as follows:
a.   patients waiting to have limbs amputated due to noninfected vascular disease. For end points, all that is needed is to count the remaining limbs. Claus Hancke’s work is most impressive in this regard;
b.   walking distance and A/B index in patients with peripheral vascular disease. In our experience, a very high percentage of patients improve. Olszewer and Jim Carter documented this. There have been a couple of negative studies published on this subject in prominent journals, but they have been seriously flawed. Stephen Olmstead has written a good research protocol to evaluate chelation treatment for peripheral artery disease that is almost ready to go. He is willing to share his work with others. Attendees at the summit expressed significant concern that opponents of the therapy might proceed with new studies that are designed to fail, which has happened in the past;
c.   brachial artery stiffness and other measurements of vulnerable plaque. Peter van der Schaar is beginning a study on arterial stiffness;
d.   diabetic patients who have evidence of vascular disease;
e.   patients who have suffered an anterior wall MI;
f.    patients who have angina that is difficult to control with drugs;
g.   macular degeneration;
h.   patients who have been told that revascularization surgery is an option;
i.    Quality of Life measurements should be included in all research projects. Chelating physicians insist that their patients feel considerably better with treatment, even though that was not found to be present in TACT.

4.  Other areas that are important to study and are likely to show successful outcomes:
a.   patients with hypertension and elevated lead levels;
b.   arterial intimal thickness and high resolution ultrasound of the carotid arteries (see the work of Robert Bard);
c.   osteoporosis;
d.   mild to moderate Alzheimer’s disease associated with heavy metal toxicity;
e.   autoimmune diseases, especially scleroderma;
f.    fibromyalgia with high levels of toxic metals detected with a challenge test.

5.  There are many biomarkers in the laboratory that can help examine the mechanisms of action of chelation therapy. Expert biochemists (Blaurock-Busch, Jaffe, Quig) are happy to consult with investigators as to which ones are most appropriate to utilize in this assessment.

6.  Various combinations of chelating agents, and different doses of such entities as EDTA and vitamin C are important to study.

7.  Chelation therapy is useful to study at all stages, to include:
a.   preventive
b.   preemptive (early signs of disease)
c.   treatment of established disease
d.   treatment following revascularization procedures
e.   maintenance treatments: very important

8.  Use of NBMI, a compound being studied by Boyd Haley, might turn out to be a powerful therapeutic modality.

9.  Such international lecturers as van der Schaar, Olszewer, Ted Rozema, Hancke, Bruce Dooley, and Gene Godfrey continue to teach physicians on how to use chelation therapy safely and effectively. Organizations such as ACAM, ICIM, and A4M hold workshops in the US. Excellent recent textbooks have been published by van der Schaar and Blaurock-Busch (both are available through the International Board of Clinical Metal Toxicology).

Conclusion
Raising public, political, and media awareness is now essential. Experienced chelating physicians can help provide solid data to support general understanding of efficacy, mechanisms, and positive outcomes in the treatment of vascular diseases. Registries might be the best way for clinicians to collect data without the constraints of a RCT. Self-insured corporations, such as Parker-Hannifin are now paying for chelation therapy. Cooperation among organizations with similar interests, such as ICIM, ACAM, AAEM A4M, ABCMT, IBCMT, and specialized laboratories is strongly encouraged to standardize protocols and set up registries. This can be done quickly and with minimal expense. Physicians from around the world should be included. Experienced chelating physicians can serve as consultants for researchers who are qualified to perform RCTs. NIH and various foundations are encouraged to fund projects discussed in this article. Pollution with heavy metals continues to get worse, and evidence is mounting that their toxicity is an important factor in the development of chronic degenerative diseases.

Cardiovascular Chelation by John Parks Trowbridge, MD, Published in Townsend Letter, May 2010

Personal Pollution and Matters of the Heart
“This can’t be happening” is often the first thought. Gripping, gnawing chest pains give way to a heavier, crushing feeling that generates fear. The idea of “indigestion” soon gives way to “impending doom.” In this setting, 9-1-1 is sometimes a reluctant last resort, after antacids and resting produce only a pitiful response.

The arrival of paramedics brings reassurances from technicians who methodically start oxygen, apply EKG leads, and prepare for transport. Nurses and doctors in the emergency room go about their duties calmly and with dispatch – starting IVs, administering medications that relieve the urgent worry. Transfer to the coronary care unit is swift and easy, and monitors beep with the soothing monotony of a metronome.

From A to Z, everything about the medical team responses engenders trust and dependence in the patient: “These folks really know what they’re doing. Thank God I got here in time.” Trusting eyes gaze into the cardiologist’s face, searching for any clues that the situation is worse than it might appear. Again, reassurance: “You’re here, you’re safe – we need to do some tests to figure out how best to fix you now.”

Slippery slope? Conveyor belt? One-way road to a “dead” end? Many terms have been applied to the “work-up” and “treatments” offered in modern cardiology and cardiovascular surgery. In point of fact, major studies 30 years ago showed that one in six bypass operations are life-saving, when high-grade blockage is worsening in the left main artery or early in the left anterior descending (LAD) artery (the “widow-maker” or “artery of sudden death”).1

Then what of the other five in every six patients? Therein lies the rub.

‘Treating’ with Tests
Everyone knows about the routine resting heart tracing: 12-lead EKG, often with a “rhythm strip” of several seconds. The predictive value is minimal in the absence of symptoms or an irregular pulse.2 A 24-hour (or longer) Holter monitor gives valuable insights into rhythm disturbances but has little use in confirming “ischemic” disease, where blood flow to regions of the heart muscle is becoming compromised. Worthy of comment is that ischemic patterns can be documented in patients without blockage in the heart arteries but with magnesium deficiency or other conditions creating episodes of heart artery spasm. Vasospasticity can constrict blood flow transiently, and chest pains, shortness of breath, weakness, pale complexion, and sweating can mimic heart “angina pains” or even “myocardial infarction (MI).”

Angina simply means reversible chest pain events, often responding to nitroglycerin-type medications. The success of these drugs produces further patient trust that the cardiologist “knows how to treat me.” Myocardial infarction results from sudden blockage of blood flow to a (small or large) portion of the heart muscle. A heart artery already narrowing from deposits of plaque is more easily blocked completely by sudden formation of a platelet plug, also called a “thrombosis” (ACS or “acute coronary syndrome”). More recent studies show that the gunk in plaque is more likely to break off if a smooth hardened surface has not formed (so-called vulnerable plaque). Such free-floating chunks will always find a smaller arteriole and lodge there, blocking blood flow beyond … a heart attack.3

Vasospastic episodes can occur in patients who have artery blockage disease and in those who do not. When tests show minimal blockage that should not be causing angina episodes, cardiologists are sometimes stumped and nevertheless recommend “revascularization” procedures: balloon angioplasty, stents, even heart artery bypass. Each of these operations is based upon a “Roto-Rooter” plumbing concept of heart disease: open the plugged pipes or simply route around them.

This “conventional cardiology concept” comes from the tests upon which they rely in figuring out how to fix heart disease.4 Simply stated, “If the only tool you have is a hammer, then all the problems you see look like nails.” Since many cardiology tests look at the “plumbing,” the treatments advised are designed to address flow blockages that can be seen. That viewpoint creates the fundamental restriction – blinders, if you will – preventing well-trained cardiologists from being able to see the value of treatments other than those in their “plumber’s toolkit.”

One of the most widely known heart tests is the “stress EKG.” A blood pressure cuff is applied, patches with electrical leads are placed on your body, you begin to walk on a treadmill, and the workout is gradually increased to a jog.5 If your legs become fatigued, if you become short of breath, or if the heart tracing shows certain changes – “flags” that indicate problems – then the test is concluded; otherwise, you race along to a calculated heart rate. Comparing your blood pressure changes to the exercise heart tracing gives a hint of how well your heart muscle is working; in other words, how well your blood is flowing to your heart and other muscles.

Even a “negative” (“normal”) stress test is often followed by a “nuclear stress test,” simply because your cardiologist “wants to be sure.” This examination starts with a stress test followed immediately by a radioactive “tracer” injected just as a fancy Geiger counter is placed over your heart. About four hours later, you are placed under the Geiger counter again. Images “after exercise stress” and “at rest” are compared – if the tracer pictures after exercise show “holes” that later “fill,” you have blockage disease restricting the blood flow. If the “holes” don’t “fill” later at rest, then you have had one or more heart attacks where muscle tissue has been replaced by thickened scar. No “holes” after exercise? Then you appear to have adequate blood flow to your heart muscle.

Even a “negative” (“normal”) nuclear stress EKG is often followed by a “coronary angiogram” (heart artery “pictures” – also called an “arteriogram” or “catheterization”), simply because your cardiologist is “being complete” in your evaluation after being admitted for chest pains. Trusting your doctor – and reassured by your test reports so far – you naïvely consent to this much more invasive test. A catheter (tube) is placed into a large artery (as in your groin) and advanced to your heart, where X-ray dye can be injected to outline the pattern of your heart arteries. One tiny technicality: the severity of diameter narrowing is commonly overestimated by 30% to 60%.6 [As the “gold standard” for coronary artery disease, angiograms have several limitations. Recently developed computerized coronary angiography instruments (not yet widely available) will help to work around some of these errors of interpretation.]

Bingo! Narrowing is likely to be identified, since you did come in with chest pains. Now your cardiologist has a reason to recommend “balloon angioplasty” (another tube, this one with a blow-up tip that crushes blockage against the wall of the artery), often with placement of a “stent” (sort of a Chinese finger-trap in reverse, where it is inserted stretched out then “springs open” to press against the wall of the blood vessel). Modern stents are “radioactive” or coated with “chemotherapy,” to reduce your body’s attempt to cover over this strange device, thereby narrowing the artery again.

Balloons? Chemotherapy? Radio­activity? You might have a few questions, but your cardiologist is reassuring that you’ll probably be able to avoid “open heart surgery” (a bypass operation). Now that’s appealing! Once again, you innocently consent to another procedure, hoping that your future will be bright and comfortable. But the results from surgery can’t ever be guaranteed.

Speaking of surgery – what happens if your cardiologist invites a cardiovascular surgeon to discuss a bypass operation with you? For the vast majority of patients, the answer is simple: your lack of knowledge about options will mean that you trustingly agree to have the surgery. Americans are suffering in droves, like lemmings to the sea: in the US in 2005, 469,000 coronary artery bypass procedures were performed on 261,000 patients. An estimated 1,265,000 “stent” procedures were performed; approximately 69% of these were performed on men and approximately 50% on people aged 65, according to the National Center for Health Statistics. During 2006, some 2,192 heart transplantations were performed.7

But What If You’re ‘One of Those Five’?
If only one in six patients has a heart bypass operation8 that is life-saving or life-extending, what is the situation for those other five patients who also often undergo the surgery? Most survive, some do not, many feel better … but their improvements might well have been possible with modern medications and lifestyle changes alone.9 Virtually every “open-heart” patient will suffer some slight or significant degree of “pump syndrome,” neurological or mental changes associated with the heart-lung pump.10 About 1 in 20 bypass patients will die during or soon after surgery. Of those who survive, over half can be expected to suffer fairly dire concerns over the next 12 months: heart attack, stroke, heart rhythm disturbance, congestive heart failure, or rising blood pressure. And each of these events will force these patients back into the trusted arms of their cardiologists and consulting medical specialists.

Perhaps one of the best reviews of the limitations, side-effects, and outright hazards of angioplasty, stents, and bypass surgery can be found in several chapters of the book, Is Heart Surgery Necessary? What Your Doctor Won’t Tell You, by Julian Whitaker, MD.1 Before undergoing any of these procedures, every patient owes his family – and him- or herself – the time to read and understand these risks, in order to question his doctors appropriately and be able to give an actual informed consent, should he so choose.

What About Treating the Patient?
Wait! Can you actually afford to wait, do you have the time – the luxury – to read this and other books, to get the true details for yourself? While doctors sometimes give the impression that “you’re a ticking time bomb, we’ve got to move quickly,” published studies have shown quite the opposite conclusion. Harvard cardiologist Peter Graboys showed, 20 years ago, that patients who chose to wait before having bypass surgery suffered no deaths from heart disease over the next 2½ years.11 A second study showed only a 1.1% annual death rate from heart disease over the following five years for those who politely (or not so!) declined to have an angiogram, likely concluding that this was just “a map for surgery” that they were reluctant to undergo.12 This rate is far below an estimated up to 5% death rate for bypass surgery. Balloon angioplasty surgery offers an estimated 1% deaths, but recurrent procedures are quite likely.

Recognize that Harvard’s cardiology staff used only routine medications available at that time, along with “usual” lifestyle changes – diet, exercise, and so on. As conventional physicians, they had little interest (or faith) in integrative technologies such as nutritional supplements or chelation therapy. The combined use of (even more modern) medications now, along with specific “orthomolecular nutrition” and chelation, would be predicted to enhance further the startling results that they obtained with minimal effort, and clinical experience supports that expectation.

Rather than progressing rapidly to invasive and potentially risky tests, an integrative physician sometimes will order a set of echocardiograms, basically “sonar” ultrasound pictures of heart muscle performance. When valves and heart muscle function appear reasonably normal and the “ejection fraction” (percentage of blood pumped from the heart with each beat) is normal or almost so, then performance has been preserved even though blockage disease might be present. Activity or exercise might display reduced capacity, consistent with blood flow reduction. A patient with frequent angina, and especially with chest pains at rest, is more likely to have blockage changes best treated first by surgery unless he or she refuses and an aggressive nonsurgical treatment program is pursued.13

The recent availability of “heart scanners” (EBT, or electron beam tomography) has helped to quantify the degree of blockage present as well as its location. This 10-minute test uses minimal radiation and gives reasonably reliable pictures, from which a heart artery diagram of calcium-hardened blockage can be constructed. Again, “high-grade” (severe) blockages early in the left-side heart arteries can move a patient toward the “surgical option” for best survival, with follow-up chelation to treat the underlying cause.

An integrative physician offering chelation therapy will, of course, review and consider cardiology tests available from other specialists in order to best plan a treatment program. Angiogram pictures, though, will rarely be required.

Nonsurgical Treatment of Heart Disease?
Can blockage disease be effectively and safely treated without surgery? The answer, as demonstrated by dozens of clinical studies and case reports over the past 50 years, is an unreserved “Yes!”

However, reduction of blockage should be considered only a possible and desirable side effect and not the goal of a chelation treatment program. An early thought in the late 1950s was that chelation “worked” by removing artery blockage. This seemed a logical way to explain observed improvements in heart function, EKG patterns, congestive heart failure, chest X-ray images, angina chest pains, shortness of breath, and activity levels.14Without question, some patients do show reduced blockage, as demonstrated by before-and-after-treatment heart scan images in two patients reported to the American Chemical Society in 1994.15 Of interest is that virtually 9 out of 10 patients show improved heart performance – but not all of those show reduced blockage disease by any test performed.16

Another factor to recognize is that our tests are less than precise in quantifying the degree of blockage present, whether improving or worsening patterns. Several assumptions are made in each test setting (heart, carotid neck arteries, abdominal aorta, legs, and so on). The presumed “gold standard” – such as heart angiograms – are difficult to interpret at best … and the same test can be read differently on different days … by the same cardiologist. If blockage doesn’t disappear with chelation, then what could explain the obvious and dramatic clinical improvements in the vast majority of patients? In actual fact, blockage probably is reduced in many arteries: a 10% to 15% increase in “cross-sectional diameter” (the area through which blood can flow, where larger diameters have less resistance to flow) produces double (or more) blood volume delivered to tissues downstream.17 Current tests fail to reliably detect such small reductions in blockage with increases in blood vessel diameter – but the patients can clearly feel and enjoy the improvements, as overwhelmingly noted with chelation therapy. The use of artery bypasses and stents is based upon increasing the diameter of a “feeding” vessel, but such operations involve many risks and the duration of improvements can be limited. Indeed, the diameter increases of bypasses and stents are noted only at the operation site and not generalized throughout the arterial system as with chelation therapy. 

Studies documenting patient improvements with chelation are well summarized elsewhere.18-20 What has received very little attention is how much these improvements can be attributed to decreased toxic metal burdens – coincidentally reducing inflammation – and other mechanisms. When platelets have less free radical inflammatory injury, they become less “sticky,” less likely to form sudden “clots” or “plugs” and completely block ailing arteries. When magnesium is provided in large doses, blood vessels more readily dilate to increase flow volume and have less spastic tendency to restrict flow. Vitamins B6 and C, amino acids lysine and proline, essential fatty acids, zinc – these and other nutritional supports that are provided during a series of chelation treatments clearly help to stimulate improved clinical function, detoxification, and tissue repair. Even nattokinase (or lumbrokinase), which lowers blood flow “viscosity” by reducing free-floating monomer fibrin strands, might help explain some of the benefits seen in advanced chelation programs.

What About ‘Personal Pollution’?
All chelating medications share in common one key property: forming a particular chemical bond with certain positively charged ions (metal atoms).21 This drug–metal complex allows for easier removal of the metals through the kidneys. In many cases, the chelating drug prefers to bond with so-called heavy metals that are toxic to the body. Reducing the presence of toxic metals allows for usual “physiologic” chemical reactions to proceed more normally.

Toxic metals insert themselves in place of appropriate metals (such as magnesium or zinc), “sitting” on active sites in enzymes and blocking needed chemical reactions. In addition, they stimulate a tremendous increase in the rate of production of “free radicals” (also described as “oxidants” or “ROTS,” “reactive oxygen toxic species”) that inflict lasting damage to body cell structures, especially those involved in the mitochondria, the tiny “energy-factories” that produce the ATP that powers all cell processes in all cells. (Antioxidant vitamins – such as vitamins C and E and beta-carotene – glutathione, and other molecules help to protect vital molecules from free radical injury.22) Another concept to describe free radical production is inflammation, the destructive and powerful process that creates the pain of arthritis, of heat and chemical burns, and basically all departures from normal function and physiology. Blockage within blood vessels, of course, is one of these “departures.”

A better understanding of how toxic metals lead to suffering and death is found in several observations over the past 40 years, almost from the time humans began in earnest to poison the planet. Animal studies have shown that heavy metals are uniformly neurotoxic, immunotoxic, carcinogenic, and directly harmful to all vital organ systems. The onset and severity of suffering depends, of course, on the dose and exposure patterns as well as cellular compartmentalization and tissue equilibration. Death follows slowly or rapidly based on the same criteria. Toxic heavy metals are throughout the environment (air, food, water, objects) and there is no way to avoid them entirely. Since they come into your body easily but leave much more slowly, all of them accumulate over time and increasingly interfere with body metabolism. 

Every person will suffer some (slight or increasingly significant) degree of impairment among his or her many organ systems, based upon his or her exposures, nutritional status, biochemistry, physiology, and so on. Basically, the “weakest link” in each individual will begin to show toxic damage first. In a more global wholistic view, virtually all human ailments (including expression of genetic aberrations) can be aggravated by – or even directly attributed to – increasing burdens of toxic heavy metals.23 Since bioaccumulation from the environment cannot be avoided, attention must be directed to minimizing exposure and removing those that have gained entry. The medical procedure of removing them, of course, is called “chelation therapy.” 

A general idea of the magnitude of “toxicity” can be gleaned from providing tainted cage water to rodents, where their only liquid source is laced with a heavy metal. Daily water intake is based on animal weight. Thus, calculations can be made regarding how much of a particular toxic metal was required to kill any individual animal. The lowest dose that killed the first one is noted. Amounts are recorded all the way up to the highest dose, the one that finally killed the last remaining animal in a group of 100. These name for this group of concentrations is lethal dose (LD), and a number is appended, to indicate the population percentage that has succumbed to that amount of toxic metal. For example, the LD1 is the concentration to kill the first animal; LD50 is enough dosage to kill half of the subjects (50 out of the 100). The LD100 dose is the amount that will kill all of the animals. 

Of greater concern to people who think they have only minimal exposure to toxics is that small amounts of different toxic heavy metals can combine to create ever more destructive changes. The overwhelming majority of people are lulled into a false sense of security that they “don’t have too much toxics on board, their levels are really ‘low.'” One rodent study showed that combining the LD1 level of mercury with 1/20th the LD1 level of lead in the cage water did not kill just 2 animals (addition), it did not kill 4 or even 8 animals (multiplication) – this seemingly inconsequential combination killed all 100 of the rodents (amplification).24 Extending the implications to human beings is sobering, particularly when we are making our environment increasingly toxic. Modern medicine has no other method to remove toxic metals (as or after they enter) than the chemical process of chelation. Indeed, this is the only FDA-approved method of detoxifying from this heavy-metal toxic body burden.

Treating the ‘Personal Pollution’
The question, does chelation work? was well answered in the very earliest studies, in the 1950s, by Norman E. Clark Sr., MD, the “father of chelation therapy in America.”25Subsequent studies have confirmed his early observations, with rare exception (and those often criticized as having faulty scientific design or controls). But two questions arise: first, will chelation help all blood vessel problems? And second, what about over-the-counter oral products that might work just as well as the intravenous treatments?

The range of occlusive (blockage) blood vessel disorders – in the heart, neck, brain, central core (including kidneys), and legs – has been widely studied. The results are uniformly positive, though the percentages of those areas that improve rise with increasing distance from the brain. As a clinical rule-of-thumb, “brain” and “eye” problems improve significantly about 75% of the time, heart problems about 88%, and leg problems about 92%. (Some studies have suggested even better results.26,27) The differences deserve further investigation, but suffice it to say that they probably relate in some degree to different forms of calcium deposition (“hardening”) in the different artery walls.

The most common diseases causing significant blood vessel blockages are diabetes (both types, especially when poorly controlled) and high blood pressure (“hypertension”). In both conditions – as in most others – the improvements with chelation can be startling. Legs scheduled for amputation – a frequent conclusion for diabetics – have been largely saved by chelation treatments.28,29 Clinical experience confirms that blood sugar control is often improved, sometimes dramatically, and dosages of insulin or oral hypoglycemics can be reduced for many patients … reducing side effects, of course.

The sugar-control implications for “metabolic syndrome” (an inaccurate title for “insulin resistance syndrome”) are overwhelming. Also misnamed “cardiometabolic syndrome,” this pattern shows elevating blood pressure, blood sugar, and triglycerides, lowered HDL (“heart protective”) cholesterol, along with enlarging waistline. This cluster of disease findings is associated with higher incidences of heart attacks and strokes, two of the top three leading killers in the US. Chelation therapy produces impressive results in these patients. Results in other disease conditions (such as Raynaud’s phenomenon, scleroderma, sys­temic lupus, rheumatoid arthritis, Parkinson’s, and so on) are similarly encouraging.30

So the second question – “over-the-counter” items that might help – raises some interesting concerns. For example, when people order the latest hyped-up bottle from a newsletter or other brochure, are they really worsening inside while they delay seeking actual, scientific, evidence-based chelation therapy? Younger people, with lesser exposures to toxics and fewer degenerative issues, might “buy some time” with such readily obtained “nutritionals.” Older folks – especially those with degenerative diseases or (even unknown) history of prolonged or extraordinary exposures – are walking straight into the lions’ den. While any one individual might live a long and fruitful life without actual chelation, the vast majority are likely to succumb to the common killers, usually at the common ages. Even sequential “negative” (“normal”) test reports showing minimal blockage changes in arteries are no protection against sudden blockage from “sticky” platelets or other results of localized inflammation.

The longer-lived European (especially Mediterranean and Baltic) societies, particularly those whose citizens remain vital and active late in life, can offer some hints as to useful dietary counsel. Sulfur – found in onions, garlic, many grains, legumes, red meats, eggs, nuts and seeds, broccoli, cabbages, even milk and asparagus – readily binds with toxic heavy metals, but only weakly. Selenium – found in brazil nuts and a variety of meats – also can bind to heavy metals. When foods are grown (or animals are raised) in sulfur- or selenium-deficient soils, they have minimal amounts of these valuable minerals. Their use as significant “chelators” – even in the form of alpha-lipoic acid or methyl-sulfonyl methane (“MSM”) or N-acetyl-cysteine (“NAC”) – has not been adequately studied.

Some publicly promoted products have cilantro, chlorella or other algae, and other botanical nostrums and are widely touted as helping to remove toxic metals. Again, their use as significant “chelators” has not been persuasively studied. Claims are made for EDTA in various products administered orally, but none of these have been subjected to rigorous scientific studies in any ways that successful intravenous EDTA chelation has been evaluated. Indeed, a number of formulas also have the nutritional element chromium listed as an ingredient in the same capsule or tablet. Once EDTA “finds” the included chromium, it binds more strongly than with almost anything else and is only slowly released. So, you get virtually no benefit from the chromium or chelation value from the oral EDTA.

If neither foods nor over-the-counter “oral chelators” offer much prospect of demonstrable lasting improvement, then what options exist other than intravenous chelation therapy? Here we are treading on “unstudied ground” once again. Heavy toxic metals interfere in so many ways – blocking enzyme and other metabolism reactions, creating inflammation, making “sticky” platelets, “rusting” the inner linings of blood vessels and thereby encouraging blockage, damaging brain and nerve functions, impairing immune defenses, encouraging the development of cancer, and so on. Theoretically the reduction of the total body burden, by any means, should aid the restoration of more normal functions.

Several chelation medications – such as D-penicillamine and DMSA – have been given orally, safely, for many years. Perhaps the detoxification of heavy metals cannot work nearly as successfully as intravenous EDTA. However, speculation can be offered: carefully prescribed use of various oral chelation medications might, over long periods of time, offer important benefits to people unable or unwilling to take in-the-vein treatments; however, they might forego some (possibly critical) improvements with artery blockage disease. In the near future, this would be a fruitful area for study by the National Center for Complementary and Alternative Medicine (in the US National Institutes of Health).

When Hot Dogs Are Banned …
Based on the studies available over the past 60 years, should we be optimistic regarding chelation therapy – whether intravenous EDTA or various oral chelator medications – finally becoming available for the majority of Americans? Absolutely not.

At a recent trial, where I was serving as an expert witness for the defense, the state medical board attorney noted: “Since EDTA and other chelation medications are approved by the FDA for removal of toxic metals, then really their use is ‘conventional’ medicine practice, not ‘alternative’ or ‘integrative,’ right?” My reply: “Well, yes, except for one teeny-tiny technicality.” “What’s that?” asked the prosecutor. “The state medical boards.” “Why do you say that?” he asked, surprised. “Isn’t that why we’re in this trial? All of the medical boards ignore approval by the FDA, ignore the clear evidence found in the medical literature, and ignore the overwhelming reports of patient benefits from chelation – and they prosecute the doctors offering the treatment, just as you are today.”

A recent pediatrics study claims that 10,000 emergency-room visits are made each year for children who are choking on hot dogs. Some six dozen reportedly die. Each year. If that many patients suffered death as a result of chelation therapy properly administered, the treatment would have been banned several dozen years ago. In sharp contrast to the “wiener losers,” whenever any single patient complains of “side effects” or – as happens every few years, when a patient ill enough to finally seek chelation treatments dies anytime during the therapy program – the state launches a full-scale investigation, usually seeking to remove the “offending” doctor’s license to practice medicine.31 As a society, we tolerate dozens of deaths from the lowly hot dog – at the same time we tolerate dozens of millions of preventable deaths and untold suffering from heart attacks, strokes, high blood pressure, kidney failure, macular degeneration, and amputations for gangrene, among the many disease conditions that could have been helped by chelation. When will the public demand a change of policy that we can believe in?

©2010 John Parks Trowbridge

Toxic metals have no purpose inside the body. Whenever present, they interfere with normal, necessary biochemical reactions, often by displacing and “substituting for” the usual physiologic metals in enzyme molecules. Impaired enzymes cease their conversions of “Substance A” to “Substance B,” eventually bringing cell metabolism, repair, and reproduction to a standstill. Apoptosis (dissolution) of such poisoned cells is the common result. Unfortunately, the toxic metal is still present in the body and can affect other cells as well. One unexpected result of osteoporosis is due to the body’s attempt to sequester (“hide”) lead in the bones, keeping it farther away from more essential cells and tissues. As bone dissipates in older age, lead is released and can cause increasing damage even though it might have been present for dozens of years. These and other observations might explain many of the wonderful results claimed by most patients, as their heavy toxic metal body burden is reduced through chelation therapy.

Common Toxic Metals
lead | mercury | arsenic | cadmium | nickel | tin | aluminum | antimony … among others

Chelation drugs have long been approved as safe and effective by the US Food and Drug Administration (FDA). In fact, the Evers case (1978) was a hallmark advance in guaranteeing that doctors may use drugs approved for one purpose for any other condition; a chelator was the subject of dispute with the government.

Commonly Used Chelators

  • Calcium-EDTA (Sodium-EDTA was recently withdrawn from the market but is available by special compounding)
  • D-penicillamine
  • DMSA
  • desferrioximine
  • DMPS (widely approved around the world, available in the US by special compounding)
  • BAL (the very first, less commonly used)

Various formulations are available, including intravenous, oral, rectal, intramuscular, and transdermal.

John TrowbridgeJohn Parks Trowbridge, MD, has been certified since 1985 as a chelation specialist by the American Board of Clinical Metal Toxicology, for which he now serves as secretary. A Fellow of the American College for Advancement in Medicine, he has served as director, officer, or president of a number of professional and public associations. Popular as a professional and public speaker, he co-authored Bantam’s bestselling The Yeast Syndrome among several other books, CDs, and DVDs. His upcoming book, Life Long Health, presents chelation perspectives gathered from 27 years of offering this treatment. He provides a broad array of integrative medical therapies at his solo practice, Life Celebrating Health in Humble (Houston), Texas: jptlch@earthlink.net, 800-FIX-PAIN.

1.   Coronary Artery Surgery Study, Veterans Administration Study, and the National Institutes of Health Study, each well summarized by Whitaker J. Is Heart Surgery Necessary? What Your Doctor Won’t Tell You. Washington, DC: Regnery Publishing; 1995.
2.   Reliance on a standard EKG can be foolhardy: despite a “normal” tracing at 2 p.m., I admitted an elderly gentlemen to a monitored bed because his story wasn’t quite right; at midnight, he was rushed to the CCU within minutes of the start of his heart attack. Had he been home, he likely would have died.
3.   Corti R, Farkouh ME, Badmon JJ. The vulnerable plaque and acute coronary syndromes. Am J Med 113(8):668-680, 2002.
4.   Each of the ideas presented here applies to other blood vessel problems as well – such as “peripheral artery disease (PAD, or “abdominal aortic aneurysm [AAA])” or “carotid artery disease” – but this commentary is focused on heart disease issues. 
5.   If arthritis, weakness, or other conditions prevent you from walking or running, medications can be injected that will race or work (“stress”) your heart, in order to perform this test.
6.   Lim MC-L. Advanced CT imaging: effective diagnosis of coronary disease. Asian Hosp Healthc Manag. http://www.asianhhm.com/diagnostics/ct_imaging.htm. Accessed February 18, 2010. 
7.   Heart disease and stroke statistics – 2008 update. A report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee.Circulation. Epub 2008;117:e25–e146.
8.   Also called “coronary artery bypass graft” operation, or “CABG” (pronounced “cabbage”)
9.   These statistics were derived in studies some 30 years ago, long before many of the advanced heart and blood pressure and rhythm-controlling medications were available to cardiologists.
10. Butler J, Rocker GM, Westaby S. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg. 1993 February;55(2):552–559.
11. Graboys TB, Biegelson B, et al. Results of a second-opinion program for coronary artery bypass grafting surgery. J Am Med Assoc. 1987;258:611–614.
12. Graboys TB, Biegelson B, et al. Results of a second-opinion trial among patients recommended for coronary angiography. J Am Med Assoc. 1992;258(2):537–540.
13. Patients often expect to receive the treatments that they have self-selected as “appropriate” – surgery is sometimes the best choice, since other treatments can be done only on live patients.
14. Clarke NE, Clarke CN, Mosher RE. The “in vivo” dissolution of metastatic calcium, an approach to atherosclerosis. Am J Med Sci. 1955;229:142–149.
15. Rubin M, Rozema TC, Casdorph HR, Scarchilli A. Cardiac decalcification by Na2MgEDTA. Presented at: American Chemical Society, 208th meeting. Washington DC, 1994; as reported in Messerli FH, ed. Cardiovascular Drug Therapy. 2nd ed. New York: WB Saunders Company; 1996:1613–1617.
16. In my clinical experience, not unusual is the patient showing clinical improvement while the follow-up heart scans show reduced calcium scores (correlating to blockage) in some arteries and increased scores in others. Further, I have had one patient whose ultrasound showed moderately severe carotid neck artery blockage; one side showed dramatic reduction of blockage while the other clearly intensified, leading to referral for carotid endarterectomy surgery on just the worsening side (“CEA”). 
17. As described by the Hagen-Poiseulle equation in fluid dynamics, ignoring that the flow of noncompressible blood across an irregular lining might show marked reduction of turbulent disruptions as the luminal diameter is increased and the plaque surface becomes smoother, leading to even greater gains in blood volume delivered distally.
18. Research sponsored by Hoekstra III PP, Gedye JL, Hoekstra Jr P, et al. Serial infusions of magnesium disodium ethyleneamine tetraacetic acid enhance perfusion in human extremities. Prepublication draft: Therma-Scan Inc., 26711 Woodward Ave., Huntington Woods, MI 48070.
19. Chappell LT, Stahl JP, Evans R. EDTA chelation therapy for vascular disease: a meta-analysis using unpublished data. J Adv Med. 1994;7:131–142.
20. A complete listing of the dozens of persuasive articles by McDonagh E, Rudolph C, et al. is available online at http://www.mcdonaghmed.com/abstracts.htm.
21. Alfred Werner won the 1913 Nobel Prize for inorganic chemistry with his delineation of “complexion” (chelation) chemistry.
22. Interestingly, two glutathione molecules might be useful for intracellular detoxification but they only weakly bind to one atom of a toxic metal. However, the GSH molecule cannot be taken by mouth and is “expensive” to produce. Glutathione is essential to be present in high enough concentrations to recycle vitamins C and E, for enhanced antioxidant protection.
23. As an example, low levels of environmental lead have shown a direct relationship with elevated blood pressure without the classic presentation of lead toxicity: Batuman V, Landy E, Maesaka JK, Wedeen RP. Contribution of lead to hypertension with renal impairment. NEJM. July 7, 1983;309(1):17–21.
24. Schubert J. Combined effects in toxicology-a rapid systematic testing procedure Cadmium, Mercury and lead. J Toxic Environ Health. 1978;4:763–776.
25. Clarke NE, Clarke CN, Mosher RE. Treatment of angina pectoris with disodium ethylene diamine tetraacetic acid. Am J Med Sci. 1956;232:654–666.
26. Olszewer E, Sabbag FC, Carter JP. A pilot double-blind study of sodium-magnesium EDTA in peripheral vascular disease. J Natl Med Assoc. 1990;82(3):173–177.
27. Olszewer E and Carter JP. EDTA chelation therapy: a retrospective study of 2,870 patients. Medical Hypoth. 1988;27:41–49.
28. Lamar CP. Chelation therapy of occlusive arteriosclerosis in diabetic patients.Angiology. 1964;15:379–394.
29. Casdorph HR, Farr CH. EDTA chelation therapy, III: treatment of peripheral arterial occlusion, an alternative to amputation. J Holistic Med. 1983;5(1):3–15.
30. Boyle AJ, Clarke NE, Mosher RE, et al. Chelation therapy in circulatory and other sclerosing diseases, such as scleroderma and rheumatoid arthritis. Fed Proc 20 (Part II supp). 1961;10:243–251.
31. Carter JP. Racketeering in Medicine: The Suppression of Alternatives. Norfolk, VA: Hampton Roads; 1992.

 

 

Consult your doctor before using any of the treatments found within this site.

Subscriptions are available for Townsend Letter, the Examiner of Alternative Medicine magazine, which is published 10 times each year.

Search our pre-2001 archives for further information. Older issues of the printed magazine are also indexed for your convenience. 
1983-2001 indices recent indices

Once you find the magazines you’d like to order, please use our convenient form, e-mail subscriptions@townsendletter.com, or call 360.385.6021 (PST).

 

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© 1983-2010 Townsend Letter for Doctors & Patients 
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Website by Sandy Hershelman Designs
May 26, 2010

A Timeline for EDTA Chelation Therapy as a Treatment for Vascular Disease by Terry Chappell, John Trowbridge, and Michael Schachter, published in Townsend Letter

Definition of Chelation:  Chelation, from the Greek word “chele” meaning claw, implies that an organic molecule binds a cation (charged mineral) in a pincer-like fashion, forming a heterocyclic ring structure. The most widely accepted (and FDA approved) use of chelation therapy is for the removal of toxic minerals such as lead from the body. A more controversial indication, discovered serendipitously during treatment of patients suffering with lead toxicity, involving the use of the chelating agent disodium ethylene diamine tetraacetic acid (EDTA), is in the treatment of all forms of atherosclerotic cardiovascular disease.

1893
Alfred Werner proposed the theory of metal-ligand binding (“the pincer-like fashion”), which provided the foundation for modern chelation chemistry and development of treatment.

1930s
The textile industry required a chelating agent to remove calcium during textile processing and this led to the synthesis of polyamino-carboxylic acids, one of which was EDTA. A patent was filed for EDTA in Germany in 1935.

1940s
Martin Rubin, PhD, professor at Georgetown University, who was involved in getting a patent for EDTA (along with chemist Frederick Bersworth), discovered its biological effects on calcium homeostasis. This led to its laboratory use as an anticoagulant, for which it is still used today (“purple-top tubes”).  Dr. Rubin helped to achieve approval by the FDA  for the treatment of lead poisoning (CaEDTA) and hypercalcemia (disodiumEDTA), and later collected the world literature on chelation.

1950s
Norman E. Clarke, Sr. and Albert Boyle separately published several articles showing improvement in patients with heart disease who were being treated for lead poisoning.

Foreman reported that high doses of disodium EDTA over a short period of time can cause kidney damage, leading to the development of safe treatment protocols.

1960s
In 1960, Dr. Marvin Seven and other authors edited a book entitled “Metal Binding in Medicine”, which contained papers on chelation that had been presented at two major symposia. Dr. Seven, who was associated with the National Institutes of Health, was killed in auto accident in 1961. This was considered by many to be a major blow to the development of EDTA chelation therapy, because he was a leading advocate of the therapy.

Kitchell and Meltzer wrote several articles reporting on positive effects of EDTA treatment for heart disease but their last article had a negative conclusion(not supported by their reported data), which discouraged further research by conventional doctors. A 1980’s re-examination and critique pointing out glaring errors in this negative article, by Cranton and Frackelton, was ignored by mainstream medicine.

Ray Evers and Carlos Lamar each collected huge volumes of anecdotal data showing vascular improvements with chelation therapy.  Lamar published his experiences in a series of articles, particularly documenting the salvage of legs with diabetic peripheral vascular disease.  Evers won a precedent-setting court case establishing that once a drug is approved for any purpose, it can be used for other indications at the discretion of a physician, which allowed the use of EDTA for vascular disease as well as for the use of dozens of other drugs by all American specialists.

In 1969, Abbott’s patent for EDTA expired, which resulted in decreased motivation to promote EDTA as a treatment for cardiovascular disease.

1970s
The American Institute of Medical Preventics, later called the American College for the Advancement in Medicine (ACAM), was formed in 1973 by Harold Harper, Ross and Garry Gordon and others to promote and teach chelation therapy. Since that time, ACAM has sponsored conferences and workshops on cutting edge subjects involving nutritional medicine and chelation therapy twice a year. Many physicians were trained in the safe administration of EDTA chelation therapy.

Garry Gordon and Robert Vance wrote an article about the mechanisms of action of EDTA chelation therapy.

Bruce Halstead wrote the book Scientific Basis of Chelation Therapy, This book was later updated by Ted Rozema.

1980s
Richard Casdorph, a practicing cardiologist, showed improvements in ejection fractions of the heart and in cerebral blood flow with chelation therapy in several articles.

McDonagh, Rudolph, and Cheraskin published about 30 articles documenting various positive effects with chelation therapy, including improvement in lipids, carotid blood flow, and lung function and no adverse effect on bone density.  This group and Cranton each wrote articles showing no problems with kidney function in patients treated with EDTA according to the published protocol.

The American Medical Association called for studies to see if chelation worked.  At the same time, conventional cardiologists wrote several editorials against the therapy.

The American Board of Chelation Therapy in 1983 was formed to certify doctors who give the therapy. It was later called the American Board of Clinical Metal Toxicology. ACAM also certified doctors who took its workshop on chelation therapy and passed its written and oral examinations.

The Great Lakes College of Clinical Medicine, later called the International College of Integrative Medicine (ICIM) was formed in 1983 to teach and do research on chelation and other integrative therapies.

After complex negotiations, in the late 1980’sWalter Reed Army Hospital agreed to do a randomized clinical trial on EDTA chelation therapy, but part way through the study it was discontinued, allegedly because the investigators were called to serve in the Gulf war and did not return to complete the study.

Frackelton and Cranton published a landmark study about free radical control as the primary mechanism for chelation therapy in 1984.

Olszewer and Carter published a study in in 1988 in Medical Hypothesis documenting 87% of vascular patients showing improvement with chelation therapy.  They later published a small cross-over clinical trial in 1990, documenting significant results in peripheral vascular disease, in the Journal of the National Medical Association.

Arlene Brecher lectured throughout the country and wrote a popular book (Forty Something Forever) promoting chelation therapy from the patient’s point of view.

Blumer and Cranton raised the possibility that EDTA therapy might prevent cancer in a population exposed to environmental lead exposure in a study with an 18-year follow-up.

1990s
Three groups of cardiovascular surgeons published small clinical trials on chelation therapy.  None had enough subjects to come close to clinical significance.  All were severely criticized in letters to the editor because of procedural errors.  All came to negative conclusions.  One even admitted that their purpose was to disprove the therapy.  At the initiative of Claus Hancke, the Guldager study was criticized for its shortcomings by the Danish supreme court.  Hancke and Flytlie published an article showing that 58/65 patients on the waiting list for cardiac bypass and 24/27 peripheral vascular patients also on a surgical waiting list were able to cancel their surgeries after receiving EDTA chelation therapy.

Peter van der Schaar, a Dutch cardiovascular surgeon, published several favorable studies and wrote a massive textbook on the therapy, recently in its 10th edition.

Michael Schachter had an article published titled: “Overview, Historical Background and Current Status of EDTA Chelation Therapy for Atherosclerosis” in 1996.

Elmer Cranton published a Textbook on Chelation Therapy, into its 2nd edition in 2001.

Terry Chappell published two meta-analyses summarizing the literature to date and coming to the conclusion that treatment with EDTA chelation therapy was very closely correlated to measurable improvement in vascular function

Opponents of chelation therapy, as well as almost all alternative therapies, call themselves “quackbusters”.  This small group of doctors has infiltrated the Federation of State Medical Boards and travels around the country making formal complaints about doctors who provide the therapy.

They tried to outlaw the therapy in California.  ACAM testified in defense of chelation and the California Medical Board voted down the proposal.

The Federal Trade Commission filed a complaint against ACAM for making a claim in a brochure that chelation was effective for vascular disease.  ACAM submitted almost 100 articles in support of the claim, but the FTC insisted that a large randomized trial was required to make that claim.  ACAM finally gave up after spending a million dollars in legal fees and signed a consent order saying they would not make such a claim any more, based on the evidence at that time.

Articles began appearing in the conventional medical literature that too much heart surgery was being done in the United States.  The outcomes from medical therapy were just as good for many patients, if not better.

Steve Olmstead, a research cardiologist from the University of Washington Medical School, wrote a 100 page monograph discussing in detail the mechanisms, chemistry, and scientific evidence on chelation therapy.  One of his conclusions was that the preponderance of the evidence was in favor of the therapy for peripheral vascular disease.  This document was distributed to every medical school library in the United States.

2000s
Representative Daniel Burton, chairman of the Congressional Oversight Committee held a hearing with testimony from the NIH and from experienced chelation physicians.  The conclusion was that a large study was clearly indicated.  Subsequently, the NIH sent out a call for proposals.  A review panel turned down the first proposal, but approved the second one, called the Trial to Assess Chelation Therapy (TACT).  The chief investigator is Gervasio A. Lamas, who is a world-renowned researcher.  Several prominent medical schools (Miami, Duke, Harvard) and experienced chelation physicians agreed to participate.

Several articles appeared in major journals showing that even small amounts of lead can increase the risk for hypertension and vascular disease.

Lin and Lin Tan published a leading article in the New England Journal of Medicinethat chelation can improve moderate non-diabetic kidney failure, presumably by removing lead and improving circulation to the kidneys.

Terry Chappell and seven colleagues published a study showing that patients with known vascular disease treated with chelation therapy had a much lower incidence of subsequent cardiac events, such as heart attacks and the need for surgery, than a comparable group of patients treated with conventional cardiac care.  These were the same end points as TACT, but the study was much smaller and was not a randomized, double-blind study.

2010s
It was reported by the Center for Disease Control (CDC) that a child died after receiving the wrong medication, disodium EDTA, in a short intravenous push.  It is very important to know that calcium EDTA, which is approved to treat lead toxicity can be given as a short IV push, but that disodium EDTA, which has been described in this timeline as a potential treatment for vascular disease, must always be given by a slow intravenous drip, at a rate no more than 1 gram per hour. Otherwise, the calcium blood level can drop dangerously fast.  The unfortunate child was given the wrong preparation, and that is the reason for the death.

Because many cardiologists discouraged patients from participating in TACT, enrollment proceeded slowly.  For several months, the study was delayed because a complaint by the “quackbusters” saying that it should be stopped immediately. The same group convinced a reporter from the Chicago Tribune to write a negative article about the study, even though no data had yet been released.  However, after seven years the study was finally completed on October 31, 2011.  The findings of the study are to be presented at the American Heart Association meeting in Los Angeles on November 4, 2012.  All we know at this point is that over 1700 patients enrolled nationwide, and the safety committee, which was active throughout the study, found no concerns for safety, using the study protocol.

Virtually all of the studies noted in the timeline used intravenous disodium EDTA with various vitamins and minerals.  The protocol for the safe administration of intravenous EDTA chelation therapy has been published by ACAM and ICIM in their training courses, and is used in certifications by ACAM and ABCMT.  Despite numerous claims, that oral EDTA might be similarly effective, there is no published evidence that oral EDTA might be helpful for treating vascular disease. Oral EDTA is only about 5% absorbed, which might make it useful for prevention for those exposed to high levels of lead on an ongoing basis, but most doctors who utilize intravenous disodium EDTA for vascular disease do not recommend oral EDTA for primary treatment.

The references for the articles cited in this timeline are available in Schachter’s historical article, in Chappell’s meta-analysis, and from L. Terry Chappell at P.O. Box 248, Bluffton, Ohio 45817 or at lterryc@wcoil.com.  A good number of additional articles and events were not included in the timeline for lack of space.

 

 

Consult your doctor before using any of the treatments found within this site.

Subscriptions are available for Townsend Letter, the Examiner of Alternative Medicine magazine, which is published 10 times each year.

Search our pre-2001 archives for further information. Older issues of the printed magazine are also indexed for your convenience.
1983-2001 indices recent indices

Once you find the magazines you’d like to order, please use our convenient form, e-mail subscriptions@townsendletter.com, or call 360.385.6021 (PST).

Who are we? | New articles | Featured topics | 
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 | Subscriptions | Contact us | Links | Classifieds | Advertise |Alternative Medicine Conference Calendar | Search site | Archives |
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© 1983-2012 Townsend Letter for Doctors & Patients
All rights reserved.