Trowbridge, MD: Stepping Into the Next 60 Years, A Historical Commentary

caduceus-1245442-639x903Chelation Therapy: Stepping Into the Next 60 Years A Historical Commentary
by John Parks Trowbridge, MD

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Reprinted from the May 2013 Townsend Letter with permission

Mind-body medicine, a term well known in medicine, has major roots in observations made in the 1960s by one of my lab directors at Stanford, George Solomon, MD. Intensive study of the “relaxation response,” “healing touch,” “acupuncture,” and similar “soft science” technologies has led to widespread acceptance in the medical and lay communities. At about the same time, startling observations were being made of reversals of increasingly prevalent coronary and peripheral vascular maladies by chelation therapy with intravenous EDTA. Despite “hard science” showing that these beneficial discoveries have been replicated time and again, chelation remains largely unknown or, at worst, vigorously defiled. Paul Dudley White, MD, President Eisenhower’s cardiologist, encountered similar resistance for over two decades to his introduction of the EKG. René Laënnec was more fortunate in securing wide acceptance of the scientific results available with his new “stethoscope” within a decade in the early 1800s. Given a world increasingly aware of pollution with toxic heavy metals, and given a population with younger onset of serious degenerative diseases, and given 60 years of overwhelmingly successful results, why have conventional medicine and regulatory government tossed chelation aside, onto the trash heap of so-called fraudulent diversions?

Going to the Dogs – and Nowhere Else?
What we now unquestioningly call “modern medicine” was largely invented since the late 1940s. Houston cardiovascular surgeon Denton Cooley, MD, studied pediatric procedures in postwar Europe, and his research efforts have saved countless children. Coronary endarterectomy was tried for occlusive disease, but most patients had diffuse involvement and were poorly qualified. Other partners of Houston cardiovascular surgeon Michael Debakey, MD, were Ed Garrett Sr., MD, and Jimmy Howell, MD. In the early 1960s, they were in the forefront of perfecting a technique of removing a peripheral vein and inserting it as an aortocoronary bypass on the heart … of dogs. Endless hours spent in the dog lab led to skills and procedures hitherto unknown. Other complementary technologies were arising at the same time, including selective coronary angiography (to identify and locate high-grade occlusion), the cardiopulmonary bypass “pump” (“heart/lung” machine), and startling advances in anesthesia and antibiosis. Still, the dogs were their only bypass “patients,” and their survival was not the object of the research.

Despite sharing with their cardiology colleagues the potential for success of their new surgical approach, no patients were forthcoming. Finally, cardiologist Ed Dennis, MD, endorsed a last-ditch effort to salvage patients moribund after their infarction. In 1964, Garrett led the team to perform the first successful coronary artery bypass procedure, at Baylor University. The early patients, already preterminal, failed to survive. With the prospect of revascularization too tantalizing to resist, stable patients with severe angina were then referred for surgery. The first two died. The third survived. And a new era of surgical success emerged.

But … Banished Forever to the Pound?
Intravenous EDTA chelation therapy was welcomed directly into patient practice in a most unusual way: in the emergency room. A child presented to the Georgetown University Hospital in 1952, clearly suffering with lead poisoning (from chewing paint off a window sill?). Pediatrician S. P. Bessman, MD, recalled a recent conference wherein neurology researcher Martin Rubin, PhD, described exchanging lead for calcium by a new “chelating” compound … in the test tube. “Can I use it in this kid? How do I dose it?” Serendipity led to clinical success and the child recovered. The case was reported in the Medical Annals, District of Columbia, later read by Norman E. Clarke Sr., MD, a cardiologist in Detroit. He was seeing plumbism (lead intoxication) in battery-factory workers, and thought to try this new chelation treatment. Soon, his patients were reporting less use of nitroglycerin, fewer angina pains, and increased activity without dyspnea. Why not, he thought, try this on “heart patients” who were not suffering with lead toxicity. They, too, dramatically improved with chelation. And a new era of medical success emerged … and was soon to be banished like an old dog.

The NIH TACT Results
Almost 60 years after the first discovery that EDTA chelation therapy could be effective in the treatment of heart and blood vessel diseases, results of the first large randomized double-blind trial were reported at the American Heart Association meeting in November 2012. A number of commentaries have identified “problems” with the 7-year-long National Institutes of Health (NIH) study, under the direction of cardiologist Gervasio Lamas, MD, of the Mt. Sinai Medical Center, Miami Beach, Florida. An 18% reduction of cardiovascular events in the entire treated group suggests a beneficial effect. However, one cadre accounted for substantial improvements: diabetic patients enjoyed a 39% decrease in adverse events compared with placebo (usual medical treatment) controls.

Given the increase in diabetes in the American population – including the younger age of onset for many victims – any treatment offering significant benefit should, in the best of possible worlds, be readily embraced.

Diabetic Complications
Research at the NIH in diabetics during the 1970s showed that normalization of blood sugars preserves endovascular and end-organ tissues, approaching the baseline health seen in normoglycemic populations. Over the past 30 years, there has been an alarming increase of obesity. Enlarging girth is often accompanied by the ominous signs of cardiometabolic syndrome, emphasizing the critical need for early and aggressive control of blood sugar. Nevertheless, ingrained societal patterns – including nutritional debasement in daily food selections – complicate efforts to achieve the lifestyle changes essential for nondrug hyperglycemic control. Drugs, of course, impose the risk of side effects and even hypoglycemic episodes, so many physicians are comfortable allowing patients to float with higher-than-normal fasting and postprandial patterns … and thus tolerating the commensurate development of occlusive changes affecting end organs.

Chronic renal dialysis is one of the most expensive repetitive procedures in modern medicine, and diabetics claim an inordinate volume of these resources. The NIH TACT trial excluded renal failure patterns in order to simplify data analysis. A seminal 2003 study by Lin and Lin-Tan, published in the New England Journal of Medicine, matched patients developing nondiabetic renal failure and carefully treated the intervention group with intravenous EDTA chelation. While the untreated observation group devolved toward dialysis, the treated patients improved toward normal kidney function, presumably due to reduction of lead in the kidneys. Many experienced chelation physicians have seen serum creatinine levels reduce over time in both their diabetic and nondiabetic patients, but a conclusive study remains to be done – and is sorely needed and could be done easily with pooled data.

Beyond Diabetes
Reports of chelation improvements in diabetics have been peppered throughout the medical literature over the past 50 years. In 1964, Carlos P. Lamar, MD, offered his diabetic patients a real chance at a more normal life, saving limbs scheduled for amputation, saving vision in those going blind, and lowering insulin dosages. Kansas City, Missouri, chelation specialists Ed W. McDonagh, DO, and Charles J. Rudolph, DO, PhD, were joined by research professional Emanuel Cheraskin, MD, DMD, to publish 31papers documenting their clinical practice experience over the 1980s and 1990s. Topics included significant improvements of vital importance to diabetics and nondiabetics alike: blood sugar, cholesterol, HDL cholesterol, triglycerides, kidney function and serum creatinine levels, artery blockage disease (even of the aorta), severe heart artery blockage, blockage of neck carotid arteries, hardening of the arteries, platelet clotting functions, fatigue, pulse rate and blood pressure, serum calcium and iron levels, trace element patterns in degenerative diseases, psychological status, and general “clinical change” (improvements) observed in chelation patients. Perhaps of more interest to many readersis the demonstrated reversal of macular degeneration (commonly seen in diabetics) reported by McDonagh and Rudolph’s group in 1994. Their evidence included retina photographs, documenting improvement consistent with increased circulation to the eyes. Pooled objective data from practicing ophthalmologists could easily document a pattern of improvement, offering hope where there is no other treatment.

Coronary Occlusive Disease
The “end organ” of most concern for diabetics and nondiabetics alike is the cardiac muscle. Heart disease “statistics” 60 years ago were generally reported as reduction in symptoms, in angina and infarction, and improvement in EKG patterns. For the past 20 years, we’ve had benefit of the ultrafast CT “heart scan,” helping outline the anatomy of calcified plaque in coronary vessels and allowing for earlier identification of those at risk. For over 50 years, selective coronary angiography has provided “a map for surgery” – but its extensive use in postoperative bypass patients has created an industry ripe for challenge as generally unnecessary and sometimes fallible. For almost 50 years, coronary artery bypass grafting (CABG) has been shown to provide a life-saving alternative for those with significant diffuse disease or “left main” or “left anterior descending” artery occlusion. The 50-year-old technologies of coronary “ballooning” and “stenting” – now impregnated for drug elution – remain popular despite the frequency of restenosis or other complications. The question of whether ultrafast CT is suitable for documenting improvements with chelation remains elusive, since some symptomatically successful patients continue to show advancing calcium scores. Collateral channels are not readily seen in these pictures or even in angiograms, so perfusion studies with stress-and-rest thallium scans can be more revealing.

Salvage of cardiac muscle is the sine qua non of all interventions. Indeed, kinase infusions within the early hours of acute infarction have preserved countless organs with minimal or no damage. Various drugs have found popularity in the conventional cardiology community as possibly reducing or delaying development of coronary occlusions. These include, of course, the “statin” drugs and antithrombotics such as clopidogrel. A number of concerns have been raised regarding their extensive side effects, including interruption of physiologic biochemistry (such as with statins, impaired synthesis of vitamin D, bile acids, coenzyme Q10, and so on). Chelation avoids these challenges to normal functions. Further, chelation has greatest success when occlusion has not progressed to tight stenosis or to the point where unstable plaque threatens to block distal flow. Coronary angiography is still risky, especially with regard to vulnerable plaque. Additionally, it is limited in not being able to discern plaque reduction that yields very slight increases in cross-sectional vessel caliber, a situation wherein fluid dynamics produces a much greater increase in flow volumes. Once again, clinical improvement is one of the best measures of success.

So the question remains: besides lifestyle changes to minimize risks, what actual treatments could enhance myocardial salvage? The almost 60-year history of consistent reports suggests that EDTA chelation has already established itself as an unrecognized but viable alternative, with patient satisfaction and clinical improvements routinely in the 90% range in published studies.

EDTA Chelation and Cardiac Disease
Beginning with Clarke’s initial reports in 1955, anecdotal papers have repeatedly documented that “heart patients” improve with a wide variety of symptoms. Angina episodes, dyspnea on exertion, blood pressure elevations, rhythm disturbances, electrocardiogram patterns – all these were shown to improve in reports over the first 10 years. Other small group reports over the past 50 years have continued to confirm these early findings. The usual critique is that they involve a small number of patients or that double-blinding is absent. These criticisms, of course, ignore that proposed CABG surgery was canceled in the majority as no longer needed, and that people are still walking on limbs scheduled for amputation.

The importance of a nonsurgical alternative for coronary disease is highlighted by a recent report on war fighter deaths over 10 years in the Middle East. Autopsies on 3832 service members, killed at an average age of 26, showed that almost 9% had some blockage forming in their heart arteries. About a quarter of these had severe blockage, yet they were asymptomatic and deployed into combat. As more sensitive diagnostic modalities are developed and widely employed, an increasing percentage of the population will “qualify” for treatment of their clinically silent diseases. In such cases, early and consistent use of chelation might dramatically lower medical care costs while improving overall health outcomes.

Anatomy vs. Microphysiology
Perhaps of greatest interest is the effort to understand why – or how – EDTA chelation is responsible for such dramatic cardiac (and other) benefits. Borrowing from the engineering concept of “opening the pipes,” such as with bypass or stenting, early explanations focused on a “Roto-Rooter” effect of “dissolving” the atherosclerotic blockage. While this effect has been observed and documented in some chelation patients over the years, such a view is probably severely limited.

Much more likely is that chelation acts in just exactly the way that it is “approved” by the Food and Drug Administration: it reduces the body burden of toxic heavy metals such as lead, arsenic, cadmium, mercury, and so on. Sadly, the conventional medical community sets the standards and those lab parameters are for acute intoxication (as reflected in blood levels) rather than for total body burden (as reflected in hair or nail clippings or by collecting urine after challenging with a chelating drug). Since the “acute exposure” tests fail to “show toxicity,” insurance carriers decline claims for reimbursement.

The significance of reducing toxic metals cannot be overstated. But the mechanisms by which this result could produce dramatic improvements remain open to rampant speculation.

An early explanation suggested that, in states of impaired antioxidant levels, cholesterol serves as an electron sponge to help protect the endothelium. Oxidized cholesterol, being a “sticky” molecule, then deposits along the vessel margin, especially at sites of branching or disrupted flow. Having a weak activity similar to that of vitamin D, oxidized cholesterol invites calcium to be deposited in a noncovalent binding. Over time, accretion of more cholesterol, calcium, and cellular detritus results in a discrete volume of occlusive plaque, subintimal and medial. Pathologist Rudolph Virchow, MD, called this metastatic calcium, since it was out of the bones and teeth but not bonded in place. Accordingly, EDTA was thought to “pinch” these available calcium atoms and thereby initiate dismantling and dissolution of the plaque. A more sophisticated view might relate to lowering of ionized calcium in circulation, stimulating release of parathyroid hormone, leading indirectly to mobilization of “releasable” calcium in hardened plaque and body tissues.

One fascinating result of such speculation is the inclusion of calcium as a toxic element when it is abnormally deposited in organs through a variety of aging and degeneration mechanisms. While babies are “soft and rubbery,” aging individuals are increasingly hardened and brittle. This one feature – reduction of metastatic calcium depositions, peppered throughout organelles and cells and interstitium as well as in plaque – might be “the key” to results with intravenous EDTA chelation. This speculation receives support from the realization that “sick mitochondria” accumulate excessive calcium and swell (especially in magnesium deficiency), disrupting the stereochemical alignment of the electron transport chain on the cristae shelves, markedly reducing the efficiency of oxidative phosphorylation and, hence, the health of the cell. One way that mitochondria “get sick” is through the selective deposition of lead and other heavy metals, disrupting mitochondrial DNA expression as well as energy production. Reversal of these mitochondrial modifications could explain many (if not most) of the clinical improvements demonstrated with EDTA treatments.

Chelation patients often report significant symptom improvement within the first half-dozen or dozen treatments, long before a major improvement in blood flow “through the pipes” is likely. When reviewing organ failings – as seen with liver, kidneys, and brain in addition to heart – such mitochondrial inefficiency might be a primary mechanism. Similarly, removal of toxic heavy metals by chelation is much more biologically cost effective than the body’s detoxification effort that leads to depletion of intracellular glutathione. Thus, chelation can help to preserve cellular antioxidant status and a more robust ability to regenerate vitamins C and E as electron donors.

Recall also that all other toxic metals are accumulating throughout the tissues as well – mercury, lead, cadmium, arsenic, and so on – with their separate contributions to free radical production and functional impairment. Iron is an essential element that can be present in excess (iron “storage” disorders, even polycythemia), where it also stimulates the generation of free radicals, which are especially toxic in metabolically active tissues such as liver and heart. Jukka T. Salonen, MD, PhD, MScPH, of Finland, reported in 1992 a large prospective study of men with no symptoms of heart disease. Over the next 3 years, the lifetime total of cigarettes smoked was the primary risk factor in those suffering myocardial infarction. The second factor was an elevated blood ferritin level (possibly correlated with a shift toward tissue acidosis). This provides an easy laboratory test to discover those at higher risk – levels rising higher above 100 ng/ml are directly associated with an increasing incidence of coronary events. The iron story is, however, complicated, and ferritin only slowly declines over dozens of EDTA chelation treatments.

A side issue is coming to the forefront: the expanding use of injectable diagnostic imaging contrast agents, such as gadolinium, iron (Feridex), and manganese (Teslascan). Urinary challenge tests with D-penicillamine in some patients have shown very high excretion levels of gadolinium. The clinical significance of these findings is unclear, but the use of chelation treatments in patients who have had repeated contrast studies might prove valuable. Gadolinium use has been linked to onset ofnephrogenic systemic fibrosis.

Another factor deserving study is the effect that chelation might have on the improvement of tissue perfusion by reducing constriction of the tiniest arterioles, which serve as a large bed of peripheral resistance vessels. Where increased arteriolar resistance opposes the systolic pressure, relaxation of these “flow-limiter” muscles can raise tissue perfusion volume considerably. Increasingly sensitive vascular lab studies and digital thermography are two inexpensive and noninvasive methods that can be used to document improved perfusion.

McDonagh and Rudolph, among others, have shown that chelation produces a more normal reduced platelet volume and increased pliability. Ease of flow through capillary beds provides increased perfusion and oxygenation help to maintain normal tissue alkalinization. Reduction of acidotic microenvironments slows the production of free-floating single fibrin fibrils from fibrinogen, further lowering viscosity in the narrow capillaries. Any combination of these microphysiologic changes could explain improved tissue viability and marked improvement in clinical symptoms and organ function.

Peripheral Vascular Disease
Being listed as a “labeled indication” by the Food and Drug Administration usually allows for insurance approval and reimbursement of treatment for a particular condition. Few people know that EDTA was listed in late-1950s editions of the Physician’s Desk Reference (PDR) as “indicated” for the treatment of peripheral vascular disease. A study with about half a dozen patients showing marked improvement had led to labeling approval. Then came the 1962 Kefauver-Harris Amendment to the Federal Food, Drug, and Cosmetic Act, requiring a review of both safety and efficacy in the approval process. When studies were considered insufficient to conform to the new standards, the indication was dropped from the label.

While early studies concentrated on cardiac improvements, concurrent benefits for occluding leg arteries attracted attention. Carlos P. Lamar, MD, in 1964 reported on legs saved from amputation. H. Richard Casdorph, MD, and Charles H. Farr, MD, PhD, confirmed these improvements in a small series in 1983, as did James P. Carter, MD, DrPH, and Efrain Olszewer, MD, in a double-blinded study published in the Journal of the National Medical Association in 1990. McDonagh and Rudolph in the 1980s documented marked enhancement of the ankle/brachial index in 117 patients with occlusive disease. Carter and Olszewer reported in 1988 on a 28-month retrospective analysis of 2870 patients treated with intravenous EDTA: peripheral arterial disease patients showed marked improvement in 91% and good improvement in another 8%. Given that surgical success is lessened with smaller vessels and when near or crossing joints, chelation as a nonsurgical alternative offers hope to thousands.

Thermography specialist Philip P. Hoekstra III, PhD, reported privately to me in 2009 the results of his 13-year study of 19,147 patients with peripheral (leg and arm) artery stenosis, not yet severe enough to require amputation. Arterial perfusion of all extremities demonstrated significant “warming”in 86% of chelated patients.

Carotid Arteries
Carotid arteries act as a special case of the peripheral vascular bed – and their improvements with chelation have been documented repeatedly. Rudolph and McDonagh described in 1991 the striking and highly significant reversal of atherosclerotic stenosis of bothinternal carotid arteries in 30 patients treated with only 30 EDTA infusions over a 10-month period. Ultrasound imaging showed that overall obstruction was decreasedby 21% – and those who showed more severestenosis had even greater reductionof blockage. Their study had been planned after their 1990 case report of one patient having an original 98% occlusion reduced to only 33% after just 30 chelation therapy treatments. Given that strokes can occur as a complication of otherwise successful carotid endarterectomy, chelation can reduce such misadventures for many. Where surgical intervention is warranted, pretreatment with chelation theoretically can improve the postoperative result. Again, more sophisticated equipment can allow easy, inexpensive, and noninvasive documentation of improvement.

Intracranial circulation responds less well. Casdorph in 1981 documented marked improvement in brain arterial flow in a small series of patients. Carter and Olszewer’s 1988 retrospective review showed markedimprovement in 24% and goodimprovement in 30% of patients with cerebrovascular and other degenerative brain diseases. Surprising results are possible. One patient presented to me 18 months poststroke, still severely limited despite constant physical therapy. After 8 chelation treatments, he proudly showed that he could walk down the hall with an assistant holding his belt in the back, and he described having gotten into and out of the tub (with assist) for the first time since his CVA. “Small-vessel ischemic disease,” with or without dementia changes, generally shows stabilization or some improvement. Alzheimer’s dementia, especially when associated with significant toxic heavy metal patterns, can show encouraging benefits when treated early with chelation.

A Potpourri of Problems
Macular degeneration is a special case of vascular supply directly to a central nerve. Direct ophthalmic observation can show gradual deterioration … and gradual improvements. The most rewarding part, though, is having a patient resume reading or once again being able to thread a needle. I asked one patient, who received several dozen chelation treatments, to read this note on a chart cover: “PATIENT IS LEGALLY BLIND.” I then asked him to read whose chart … “Why, that’s mine!” Without glasses.

Atrial fibrillation is the most common arrhythmia, and its frequency elevates with advancing age. The risk of stroke increases considerably, so rhythm control has benefits beyond rising perfusion efficiency. Alfred Soffer, MD, reported on chelation for various heart rhythm disturbances in his 1964 monograph; results were variable but promising. Long-experienced chelation physicians have their anecdotal stories of patients reverting to and maintaining sinus rhythm.

Cardiac valvular sclerosis, sometimes proceeding to calcific stenosis restricting flow and allowing regurgitation, is a troubling problem. Although new percutaneous operations (using technology similar to angiography) are growing in popularity, their risks and success rates are still being evaluated. Theoretically, the decalcifying effect of EDTA chelation therapy should slow (perhaps even reverse?) sclerotic-to-stenotic change. At the very least, chelation should be expected to aid the intended surgical result by increasing the pliability of tissues. Neither angiography nor echocardiography is yet sensitive enough to detect slight reductions in calcium deposits.

Scleroderma is another special case, where distinctive arteriolar changes (in all organs but especially the skin) are associated with autoimmune patterns. Raynaud’s phenomenon appears to be prodromal in many patients. Conventional medications are often frustrating, and the addition of EDTA chelation therapy has been quite successful for many patients. Similarly, other autoimmune patterns – rheumatoid arthritis and systemic lupus erythematosus – have shown promising improvements with chelation. Benefits with “fibromyalgia” have routinely been reported by patients. These observations raise speculation that EDTA might be affecting membrane pathology, possibly related to or amplified by toxic heavy metals – induced through the mechanism of free radical attack? D-penicillamine, loosely called a “chelator” but acting by means of paired thiol groups, has long been used in conventional medicine to help with scleroderma and rheumatoid patterns.

Mitochondrial pathology has been recognized in many forms over the past decade, but the contribution of toxic heavy metals has been poorly appreciated. In the 1990s, laboratory studies by the Environmental Protection Agency showed startling changes in mitochondrial protein production seen in isolated organelles after exposure to “physiologic” levels of lead. Research into toxic heavy metal effects on mitochondria, endoplasmic reticulum, nuclear membranes, and cell-limiting membranes might offer the most fruitful future explanations for pathology and chelation benefits – but the laboratory funding required would be substantial.

Along Came A Spider …
A little-known effect of chelation is to neutralize biological venoms from snakes, spiders, scorpions, and the like. These poisons are a mixture of metalloenzymes, and inactivation occurs with displacement or removal of the critical metal cation. Appropriate research could lead to treatment protocols (intravenous, oral, topical) far more effective – and dramatically less expensive – than current antivenom preparations, which can cost thousands of dollars.

Venoms, as metalloenzymes, bring up a whole realm of possible treatments aimed at specific induction and function of enzymes throughout the body. In perhaps a third of instances, physiologic cations (magnesium, zinc, iron, manganese, molybdenum, copper, others) are positioned in the active site and help establish the functional conformation of the protein. As research shows which enzyme clusters are more sensitive to inhibition by toxic heavy metals displacing the expected cation, the prospect of targeted chelation could become a reality. One factor complicating targeted treatment is that chelators need to penetrate through the interstitial space into the cytoplasm and into mitochondria and even into the nuclear space. Similar concerns arise with penetrating the blood–brain barrier. Nanoparticle delivery systems, being developed for targeted chemotherapy, might be designed to enhance chelation efficiency at the “end-organelle” level rather than merely the “end-organ.” Again, laboratory and clinical expenses could be a major barrier.

Nutritional physiology is still poorly understood, and studies might reveal new ways to increase the benefits of chelation treatments. Mildred S. Seelig, MD, MPH, confirmed in the 1980s that higher blood levels of magnesium are correlated with reduced complications of myocardial infarction. Chelation therapists have long added extra magnesium to intravenous EDTA in order to amplify many of the cardiovascular benefits of treatment. Realizing that lower magnesium levels are common in diabetes, hypertension, atherosclerosis, cardiomyopathy, and a panoply of other pathologies opens an interesting door: what minerals (and vitamins), when supplemented specifically, might enhance the effectiveness of chelation treatments in particular clinical settings? Incidentally, in patients who appear to have an “allergic” reaction to a chelating drug, supplementation with molybdenum might blunt that response for the future.

Stem cell implants offer special considerations here – could they be more effective when combined with certain minerals … or after bathing in selective chelation solutions? Rotifers are primitive multicellular microscopic waterborne “animals” that accumulate calcium over their lifespan. Alfred M. Sincock, PhD, reported in 1975 on almost doubling the lifespan by bathing the organisms in various calcium-binding chelators. Similarly, the length of DNA telomeres – hence, the potential number of cell replications before genetic losses – might also be preserved by chelation treatments. The possible interactions of hormones and EDTA or other chelators is a field ripe for investigation. These cell physiology studies are technical and expensive, but the benefits might be unexpectedly rewarding.

Cost/Benefit Comparisons
Given the socioeconomic impact of medical and health choices, no discussion is complete without highlighting the “competing therapies” for cardiovascular and other diseases. Chelation treatments reasonably cost about $5 to $10,000 to produce outstanding benefit for about 90% of patients with coronary, carotid, or peripheral vascular disease. Or all three at the same time. While surgery addresses only a few inches of “blockage” with each operation, chelation works throughout the body – a real bargain for the majority of patients, who have diffuse disease. Charges for CABG range about $75 to $150,000 – for each operation – assuming no serious complications requiring extended hospitalization. A small but certain percentage of bypass patients (perhaps 2% to 3% or more, depending on many factors, especially comorbidities or more profound blockage) never return home. Many patients suffer with postoperative morbidity, including myocardial infarction, stroke, rhythm disturbances, worsening high blood pressure, and neurocognitive changes (“pump syndrome”). Repeat operations are frustratingly common, often within 10 years. (If it worked so well the first time, why is another operation needed?) Aorta and peripheral vascular operations usually cost one-third to one-half of heart bypass procedures. Balloon angioplasty and stenting are increasingly popular (with a failure rate of about 5%), reducing the need for open surgery of the chest or limbs except for those with critical ischemia. Perhaps 20% of patients require repeated angioplasty procedures, dramatically changing the cost profiles with each session ranging from about $30 to $50,000. L. Terry Chappell, MD, and John P. Stahl, MD, in 1993 published a meta-analysis of 19 carefully qualifying studies, concluding that almost 90% of cardiovascular patients showed objective clinical improvements. The savings possible with the early choice of chelation rather than the later choice of repeated operations will become increasingly important for an aging population.

Intracranial small vessel ischemic disease is virtually untreatable by conventional means, so even slight improvements with chelation therapy are a bargain at any price. Similarly, degenerative patterns such as scleroderma, rheumatoid arthritis, macular degeneration, distal peripheral arterial occlusion, and nondiabetic chronic renal failure are poorly treated with traditional approaches, making chelation appealing and very cost effective. Perhaps the “greatest value” is seen in vague or poorly diagnosable medical conditions – including fatigue, asthenia, delayed healing, a sense of “unwellness,” multiple sclerosis – wherein chelation can provide benefits not seen with aggressive drug treatments or even surgery. Stubborn infectious diseases, such as Lyme disease or even MRSA, can show improvement with chelation. While the mechanisms of action often remain obscure, the clinical benefits can be quite obvious in patients’ lives. A “chelation registry” might document improvements across a broad range of pathologies, but the effort would be expensive and likely of little value in convincing skeptics.

One other factor should be addressed: cancer prevention. Walter Blumer, MD, in Switzerland reported his experience in 1980 with calcium EDTA intravenous treatments administered over 10 years, showing a 90% reduction in cancer incidence in the 59 patients. His follow-up report showed a 90% reduction in cancer deaths over 18 years, compared with the untreated controls similarly exposed to lead from automobile exhaust, industrial pollution, and other carcinogens. When treating heart and vascular disease, magnesium EDTA is preferred, in order to “mobilize calcium and reduce blockage.” In a private communication related to me by Garry Gordon, DO, MD(H), Blumer noted that his patients “didn’t suffer with heart attacks.” These delightful results are most likely related to removal of toxic heavy metals, since calcium EDTA does not perturb ionized calcium levels, but unknown effects of EDTA might contribute as well. Considering that cancers of all cell types are the third leading cause of death in the US, what could be the true prevention benefit when the cost of chelation treatment is compared with that of traditional oncology care?

Any review of environmental toxic metal exposures shows the alarming explosion of pollution concentrating up the food chains in the biosphere. One area where unexpected progress is coming is with mercury exposure from dental amalgams. The just-completed World Mercury Treaty, a three-year project of the World Health Organization, proposes that countries completely phase out their reliance on mercury restorations in both children and adults. Controversial studies have related mercury to autism and Alzheimer’s dementia, among other problems. The startling fact is that many adults are unknowingly carrying around their primary source of the world’s most potent neurotoxin, in their “fillings” or root canals. This raises the specter of worsening environmental pollution through the water effluent from dental offices as these restorations are replaced, because mercury scavenging units – to be disposed of as biohazard waste – are not yet in widespread use. Boyd Haley, PhD, emeritus chair of chemistry at the University of Kentucky, assures us that newer chelating compounds are in development and that they could be used not only orally in humans but also to remediate mercury-contaminated rivers and bodies of water.

Blumer’s study, among others, provokes a critical question: If removal of toxic heavy metals is the most important factor in producing clinical results, how much can be accomplished by using oral “chelating” drugs, alone or in combination with intravenous chelation? Oral administration is much easier, has fewer risks, and can be applied across broad populations, especially in a preventive context or to address early pathophysiology. Since 1995, I’ve used customized combined programs of oral chelators along with intravenous EDTA. Our early studies suggested more rapid reductions in the body burden of toxic heavy metals. Further research into dithiol compounds as well as classical chelators might be very cost effective and exceptionally fruitful. If taste-enhancing technology can mask the noxious sulfur aroma of oral chelators, the potential exists for design of prescription “chelator foods,” vastly expanding the access for this treatment approach. These would be “drug-supplemented” foods, not merely sulfur-rich onions and garlic.

Some Final Thoughts
The great majority of our “medical” problems are directly related to “personal health choices,” known as lifestyle issues: tobacco use, alcohol excess, caloric surplus, nutritionally bereft foods, poor choice of food variety, sedentary habits, dental deterioration, limited sleep, unlimited stress, and so on. Unsuspected toxic heavy metal and chemical exposures challenge our organ performance at a rapidly expanding pace. Where personal responsibility fails to minimize our survival threats, what should be the societal commitment of resources to restore function and comfort?

The future face of medical care is difficult to predict. An enlarging patient base in the US poses increasing financial demands on already stressed budgets. Technological advances can be expected in virtually every arena, from diagnostic testing through treatment planning. CT scans, MRIs, and PET scans have sharpened our accuracy and understanding to allow earlier diagnosis and treatment, for better outcomes and longer survival. Same-day surgicenters and endoscopic procedures dramatically reduced the costs associated with many common procedures, such as cholecystectomy and most knee repairs. Will the changes still to come bring similar cost savings or will they, like organ transplant procedures, impose greater economic strains on a nation unprepared to ration “high-tech” care?

Victor Fuchs, PhD, in his seminal book Who Shall Live?, claimed in 1974 that we must deliver the very best care to the president because of his critical position in the society – but he cautioned that we simply cannot afford to deliver “presidential medicine” to the people. Just because we can do it – CABG surgery, angioplasty, total joint replacement, organ transplants – challenges us with the ethical question of whether we should do it. Or do it for some but not for others. Or do it for younger adults but not for “the elderly.” The reasonable cost and minimal resources required to offer chelation therapy “to the masses” suggest that this largely ignored treatment might soon evolve to play central roles in both preventive and therapeutic spheres in our emerging care system.

Dayton: Chelation Therapy: Yesterday, Today, and Tomorrow

88_dr_dayton_computerby Martin Dayton, DO, MD, MD(h)
Reprinted from the February/March 2006 Townsend Letter with permission

Chelation (pronounced ke’lat’shun) therapy in medicine is generally regarded to be the use of chelating agents to remove toxic heavy metals from the body. Toxic heavy metals include – but are not limited to – arsenic, cadmium, lead, and mercury. All metals, however, can be toxic when present in large enough concentrations.

The first widely used medical chelating agent, British Anti-Lewisite (BAL), also known as dimercaprol, was developed in the 1940s. Lewisite is an arsenic-based compound used in gas warfare. The chelating agent Ethylene Diamine Tetra Acetic Acid (EDTA) was also first used clinically in the 1940s. EDTA comes in two injectable forms that have been approved by the U.S. Food and Drug Administration (FDA): Calcium disodium EDTA, to treat lead toxicity; and Disodium EDTA, to treat elevated blood concentrations of calcium. EDTA is effective in removing calcium while BAL is not. BAL is effective in removing mercury, but not calcium. Both remove lead. These and other medical chelating agents such as 2, 3 dimercapto-propane sulfonate (DMPS), dimercaptosuccinic acid (DMSA), 3-mercapto-D-valine (penicilliamine), and desferrioxamine (DFO), all have distinctive characteristics governing circumstance-dependent usefulness.

Magnesium disodium EDTA is created by the addition of magnesium to commercially available disodium EDTA. This is the form of ETDA complex that has been popularly used to intravenously treat cardiovascular, autoimmune, and other degenerative diseases. Despite five decades of use in the treatment of cardiovascular disease, intravenous EDTA is not embraced by mainstream medicine nor approved by the FDA for treatment of cardiovascular conditions.

Studies favoring the use of intravenous EDTA in treatment of cardiovascular disease and other degenerative diseases have appeared in the medical literature since the 1950s. In 1956, N.E. Clarke published a study in the American Journal of Science, in which results showed that 19 of the 20 patients with angina studied received unusual relief, with some patients experiencing a normalization of electrocardiograms. Other benefits reported during this period, still being reported today, include improved memory; better sight; hearing and smell; and an increase in energy. Heavy metal toxicity interferes with normal physiologic function and repair, leading to numerous symptoms and contributing to many diseases. Multiple conditions may be alleviated simultaneously in the same person through reduction of heavy metal toxicity.

Various studies, both pro and con, have been performed to test the benefits of chelation therapy. However, studies performed thus far have been unable to gain universal acceptance because they were either too small (in number of subjects), not of acceptable design, scientifically biased, or otherwise flawed. In a 1993 study by L.T. Chappell. et al. in the Journal of Advancement in Medicine, the authors examined the overall effects of chelation therapy on 22,765 patients. Of those patients, 87% demonstrated objective benefit. Since then, the popularity of chelation therapy has continued to grow with ever-increasing numbers of success stories. Battles have raged, as they continue to rage today, between physicians promoting chelation, based upon best available evidence, and mainstream conservative clinicians who wish to restrict chelation usage unless a universally accepted study is performed that definitively proves efficacy. Approximately a decade after the study mentioned above, the National Institutes of Health gave the nod and, more importantly, $30,000,000 in funding, to perform a definitive study with 2,372 patients, 50 years of age or older, who have a history of a previous heart attack. The study is taking place at over 100 private medical offices, clinics, and centers across the USA, including prestigious institutions such as Mount Sinai Hospital, Miami Beach; the Mayo Clinic; and the University of Missouri .

The study, Trial to Assess Chelation Therapy (TACT), is led by cardiologist GervasioA.Lamas, MD, director of cardiovascular research and academic affairs at Mount Sinai Medical Center, Miami Beach. The study was carefully designed with input and agreement from both mainstream physicians and experts experienced in chelation therapy.

TACT follows a randomized double-blind format. Participating patients are placed into four different groups via a randomization process to help assure homogeneity.

One-half of the patients are given intravenous infusions of magnesium EDTA, while the other half receives infusions of a liquid placebo. All patients receive oral vitamin and mineral supplements to take home. To distinguish the contribution of the vitamin and mineral supplements from that of the intravenous infusions to clinical outcome, the two groups are subdivided into equal numbers of participants, each receiving either high-dose or low-dose vitamin and mineral supplements. The actual compositions of the infusions administered and supplements dispensed are not disclosed to the patients or to the administering /dispensing personnel, hence, the phrase, double-blind. All treatment records are coded for later evaluation.

Patients receive three-hour infusions weekly for 30 weeks, followed by ten more bi-weekly infusions for a total of 40 infusions. Throughout the study, routine medical care otherwise continues as before under the care of the patients’ own physicians. All patients participating are followed until the end of the study, up to five years, to determine presence or absence of clinical benefits, such as reduced incidence of heart attack, stroke, hospitalization for angina, coronary revascularization, and death. Effects on quality of life and cost of health care savings will also be assessed. In addition to potentially gaining personal health benefits at no cost, patients participating in the study are also rewarded in knowing that their participation will contribute to the future well being of others who have or are at risk of developing coronary artery disease. If TACT proves chelation to be effective and cost-effective, mainstream medicine will be forever changed for the better. There is no charge to patients for participating.

For information in regard to TACT or participating in TACT call or visit the following:888-644-6226

Web sites:
http://nccam.nci.nih.gov/chelation/studysite.htm
http://www.clinicaltrials.gov/show/NCT00044213

EDTA may be used preventively as well as therapeutically. W.Blumer and E.M.Cranton published a study in the Journal of Advancement of Medicine, which followed 231 subjects over the course of 18 years and reported a 90% reduction in cancer mortality in patients who had received ten or more Calcium EDTA infusions compared to those who did not.

Oral EDTA is used today preventively and therapeutically. Despite a five-percent EDTA absorption per the oral route, studies have validated benefit. EDTA may also enhance detoxification in form of rectal suppositories and as an additive to bath water.

Transdermal use of DMPS, a sulfur-containing chelator, provides benefit where other routes of DMPS administration are less desirous. Sulfur-containing foods such as eggs, garlic, and broccoli contribute to reducing the body burden of susceptible toxic metals. The common herb/spice cilantro has gained much recognition for its ability to reduce toxic metal burden. Nutritional supplements such as ascorbic acid, lipoic acid, malic acid, and DL methionine may be used to address metal toxicity as circumstances dictate. Various non-prescription preparations synergistically combining substances to enhance chelating properties are constantly being introduced into the marketplace. An innovative product based on zeolite has recently been introduced. Infrared heat saunas, magnetic mattresses, galvanic current, mineral baths, and sweat-inducing exercise also have proven to benefit metal toxicity.

Metabolic and genomic testing offers information regarding our individual abilities to detoxify. With such information in hand, physicians can target inherited and acquired weaknesses nutritionally, medically, and via lifestyle modification to aid heavy metal detoxification.

Drs. A. Yasko and G. Gordon are researching the viral influences that affect heavy metal retention. The use of virus-specific, RNA-based oral supplementation has demonstrated impressive clinical results in detoxification of heavy metals recalcitrant to previous attempts of removal with chelating agents alone. This futuristic technology is available for use today.

For more information, visit the following web sites: www.autismanswer.com; www.holistichealth.com; www.gordonresearch.com

The American Board of Chelation Therapy, which certifies physicians with toxic metal expertise, inclusive of chelation therapy, has recently changed its name to the American Board of Clinical Metal Toxicology. This was done in part to better reflect the need to address the bigger picture of heavy metal toxicity. We need to be environmentally proactive, to clean up contaminated areas, to control industrial and agricultural wastes, to remove toxic metals from vaccines and dentistry, and to educate the public in regard to the presence of toxic metals in products we use, including the foods we consume.

Organizations sponsoring chelation training for physicians include the following: American College for Advancement in Medicine (ACAM)
800-532-3688
Web site: http://www.acam.org

International College of Integrative Medicine (ICIM)
866-464-5226
Web site: http://www.icimed.com

Chelation: Technical Sidebar
Chemically, chelation is the process of binding an electrically charged metal atom with another molecule, the chelating agent (chelator), to form heterocyclic ring molecular structures. A heterocyclic ring contains dissimilar atoms. Chelating agents are molecules that have the capacity to form such structures when binding with metals. The electrical charge of the metal is neutralized by the sharing of electrons in chemical bonds between the metal and chelating agent. The resultant metal complex is a chelate. Such chemical bonds have been metaphorically depicted as grasping pincers of a claw. The word chelation is derived from the Greek language, chele, meaning claw.

EDTA Metal Metal – EDTA
The metal is generically depicted by the letter M. Metals that bind to EDTA include metals essential to life, such as magnesium and calcium, as well as toxic metals, such as cadmium and lead. Any metal can be toxic when present in too great a quantity. Nitrogen (N), oxygen (O) and carbon (C) atoms compose the basic ring elements of EDTA. The letter H depicts a hydrogen atom bonded with oxygen (O) to form OH. H2 depicts two hydrogen atoms, which are bound to ring forming carbon (C) atoms. The single solid lines ( / ) between EDTA ring forming atoms represent single chemical bonds. The parallel lines (=) reflect double chemical bonds. The broken lines (—) depict “claw-like” bonds between non-metallic elements of EDTA and the chelated metal (M). Although Sulfur (S) atoms are not found in EDTA, they may be found in other chelating agents. The distinct chemical makeup of various chelating agents provide them with unique abilities to bind different metals under differing circumstances. Chelating agents are selected for therapeutic use based on their respective properties.

Chelation may be used to deliver metals into and remove metals from the body. Magnesium ascorbate (vitamin C) is a chelate found in orange juice and in nutritional supplements. Chelation involves reversible binding of metals. Thus, ascorbate may release the essential metal magnesium in the body and complex with the toxic metal lead to form lead chelate. The lead exits the body complexed as lead chelate, reducing the body burden of lead. Chelates generally exit the body through the kidneys, via urine or through the bile via the stool. However, chelates may not necessarily eliminate toxic metals, but rather redistribute them in the body. Since many orange juice drinkers and daily vitamin and mineral-tablet users have excess mineral toxicity and related diseases, the medical field of clinical metal toxicology has much to offer. Clinical metal toxicology, which includes chelation therapy, deals with various issues in regard to preventing and reducing metal toxicity.

Chelating agents are prevalently found in industry, including textile dyeing, water softening, enzyme deactivation, and food preservation. Besides being useful in medicine, chelation is essential for life. Chlorophyll is a chelate of the metal magnesium. Vitamin B12 is a chelate of cobalt. Heme, a component of hemoglobin, is a chelate of iron.

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