In February 1982, a revised insert was added to the Medicare Carriers Manual, stating "our decision not to cover Chelation therapy for the prevention or treatment of atherosclerosis is based on PHS's findings that there is a lack of well-designed, controlled clinical trials of its effectiveness, and that the risks to health and safety attendant upon its use are a cause for concern." EDTA is an FDA-approved drug. It is approved for the removal of metal ions in heavy metal poisoning. Normally, any use of an FDA-approved drug prescribed by a physician is covered…Why, then, is EDTA the "Exception to the rule?"
A clinical trial of effectiveness is based on statistics derived from use on human subjects over a period of time. Physicians using EDTA for atherosclerosis have recorded and documented an excess of 1000 reports, involving thousands of case studies and established without any doubt that EDTA Chelation improves circulation in atherosclerosis. Yet, red tape has consistently blocked its acceptance and use in treatment in the United States.
FDA Refuses to Examine Evidence
Normally, when a drug is observed to improve a major killing disease, there is a rush to research and approve the drug in order to make it immediately available to the victims of the disease. Why, then, is there such a sluggish response in the case of EDTA Chelation? As demonstrated by reference to existing scientific literature, EDTA therapy is a safe and effective treatment for atherosclerosis. In 1962, the FDA was required to examine the effectiveness of drugs marketed from 1938 to 1962, which included EDTA. As a result of the review, the FDA gave manufacturers the opportunity to submit evidence to support EDTA effectiveness in treatment of occlusive vascular disorders. The manufacturers of EDTA chose not to respond. However, the American Academy of Medical Preventics did respond. The Academy submitted reams of data on EDTA to the FDA, but the FDA refused to review the data! At a time when official concern for escalating health care costs is heightened, chelation therapy fits the criteria espoused officially for reducing costs. The therapy does not require hospitalization, or surgery, and the lasting effects of EDTA chelation equal or exceed those of alternate treatments. The FDA has received extensive documentation stating those conclusions. Yet, the FDA continues to effectively block the use and application of EDTA chelation. These critics of EDTA repeatedly refer to obsolete studies, written by scientists with little personal expertise in the use of EDTA for occlusive arterial disease.
Hundreds of thousands of coronary artery bypass surgical procedures have been performed without benefit of controlled studies to prove safety and effectiveness. Medical insurance companies, including Medicare, have traditionally paid for these very expensive surgical procedures without exception. The U.S. Public Health Service evaluated and recommended against the use of EDTA for the treatment of occlusive arterial disease. They based their conclusions on recommendations from cardiovascular surgeons, from the American Heart Association, and the American College of Cardiology, assuming that those groups represent experts in the field of EDTA therapy.
Politically powerful and traditional medical organizations have a vested interest in arterial bypass surgery. This is a $2 billion-a-year industry! Many hospitals depend on these procedures for financial stability and the surgeons derive their income from bypass surgery and related treatment. A successful cardiovascular surgeon earns up to $500,000 each year. Yet, these are the very people asked to evaluate the effectiveness of an alternative treatment. Is there any way the FDA can claim to have obtained an unbiased opinion?
Toxicology of EDTA: Are the Risks a Serious Cause for Concern?
Stedman's Medical Dictionary defines toxicology as "the science of poisons—their source, chemical composition, action, tests, and antidotes." Normally, one speaks of poisons as those chemicals, drugs, and biologicals that induce severe illness, bodily injury, and/or fatality. Examples are lye, arsenic, and cobra venom. These substances induce poisoning in minimal quantities.
One does not consider, usually, baking soda, aspirin, or adrenaline as poisons, at least in the relatively small dosages to which we are exposed. This brings up a key point of toxicology. That is, at what dosage, or concentration does a chemical begin to induce poisoning? For substances such as baking soda, the dose level has to be quite high before symptoms of illness begin. Indeed, there is a quantitatively defined level for each and every substance beyond which toxic reactions occur. Therefore, every substance has a point of toxicity; even such beneficial things as water and vitamins. EDTA chelation, then, has toxicity at some measurable level. The question arises, what is that level at which EDTA induces toxicity, and is that level relevant to the normal concentration used in an EDTA treatment program?
According to a recent article in the Wall Street Journal (9/82), the American Medical Association is quoted as stating in unconditional terms that EDTA chelation is dangerous. Let's see how dangerous EDTA actually is in pure toxicological terms. Toxicology defines the lethal dose (LD50) as the concentration of a specified substance which will induce death in 50% of the organisms to which it is exposed. The LD50 is the official standard used in medical pharmacology to determine and define the lethal dose and compare it with (he drug's effective dose, that is, the dose that is maximally beneficial. When the effective dose equals or is only slightly less than the LD50, there is only a minimal or no margin of safety between effective treatment and death. The drug digoxin (digitalis), used in treatment of heart failure, has an LD50 which is only five times greater than its effective dose. This means, for instance, if a patient is prescribed 0.25 mg. of digoxin, and the patient consumes 1.25 mg. of digoxin, he stands a reasonable chance of serious poisoning, and possibly death (at a dose only 5 times greater than the regularly prescribed level.) Thus, digoxin is a relatively dangerous medication. If the Wall Street Journal article's premise is correct, that EDTA is dangerous, it is reasonable to expect that the comparative LDso safety margin of EDTA would be at least as bad, if not worse, than digoxin. In other words, in comparing two drugs, digoxin and EDTA, the safest drug is the one with the highest LD50 in relation to the effective dose.
In The Scientific Basis of EDTA Chelation Therapy by Bruce Halstead, M.D. (1979, Golden Quill Publishers, Colton, CA) reference is made to toxicological studies of Barnes (1964), Stecher (1968), Christensen (1974), and Catsch (1976). Using the rat as a testing animal, these investigators injected EDTA and other drugs or substances into the abdominal cavity. The LD50 was measured for each. The results are listed below:
LD50 Values for Drugs Injected in Rat
1. EDTA: 1900 milligrams per kilogram weight of the rat
2. Aspirin: 420 milligrams per kilogram weight of the rat
3. Digitoxin: 3.7 milligrams per kilogram weight of the rat
4. Tetracycline: 320 milligrams per kilogram weight of the rat
5. Ethyl alcohol (liquor): 1225 milligrams per kilogram weight of the rat
It is clear in this data that EDTA has a much higher lethal dose50 than the commonly used heart medication digitoxin, the pain remedy aspirin, and the antibiotic tetracycline. The opinion of the AMA fails to provide any new data on LD50 of EDTA that clearly demonstrates a dangerous toxicity (which is expected if EDTA is truly dangerous.)
A specifically named risk widely proclaimed by opponents of EDTA treatment is its possible toxicity to the kidney, known as nephrotoxicity. A comment can be made that all substances, as previously mentioned, have toxicity, including kidney toxicity. The risks of kidney toxicity are dependent on the level of the chemical in the body within a given length of time. In Halstead's evaluation of EDTA chelation, nephrotoxicity is generally the "result of using dangerously high doses of the drug and too rapid a rate of infusion." The protocol currently under use for EDTA chelation specifies maximal concentrations of EDTA, maximal frequency of infusion of EDTA, and provision for rest between treatments. Yes, kidney toxicity is a documented fact, as it is with many other beneficial drugs. But today, a case of kidney toxicity is very rare, because of the limited dose and frequency, and careful laboratory monitoring of the kidney and genito-urinary system.
Beyond the kidney dysfunction and toxicity, it is possible to experience transient symptoms such as post-treatment hypocalcemia (calcium drop), and some patients have complained of headaches, nausea, weakness, fatigue, anemia, and dermatitis, but these reactions are rare, and may be a result of element and vitamin deficiency. In terms of the actual chelation process, the risks of EDTA DO NOT POSE CAUSE FOR CONCERN.
The Joy of Chelation Therapy
Can any medical treatment be a joy, a pleasure? Not many, not even a few can claim such bliss. One treatment, however, may fill such a role. The process of EDTA chelation therapy is noticeably cheering to the patient. The method of chelation appears outwardly to be all-so-medical. An individual is plugged into an I.V. bottle containing EDTA in solution. Sitting for three to four hours, watching the liquid drip slowly into one's arm is hardly entertainment! Or is it? Observing a group of patients receiving EDTA chelation in the doctor's office is a remarkable experience. One sees live and gregarious activity, friendly discussion, sharing medical and personal experience, laughter, mutual and fraternal association and even new friendships. Of course, these are hallmarks of any group activity, but how many groups are centered around medical treatments? EDTA chelation is not a philosophy, an encounter group, nor a fraternal society. It is an AMA-approved treatment for lead poisoning. Moreover, it is a process for reversing atherosclerosis, the disease that clogs the arteries. That such a treatment is a joy is something observed in hundreds of offices throughout the U.S., including this one, on a daily basis. It is a celebration of hope.
What makes chelation a joy? The first and foremost concern is that EDTA is a drug, a chemical, and therefore certain to cause certain side effects and possibly a serious toxicity. Nothing could be further from the truth. Let's look at sheer statistics. Bruce Halstead, M.D., has documented careful scientific studies of the toxicity of EDTA. On a scale of 1 to 10, where one is the most safe and ten is the most hazardous, EDTA ranks close to aspirin, about 2 to 3. A major heart medication derived from digitalis ranks 7 to 8. Doctors treating a certain disease may think nothing of prescribing a drug with a high toxicity, when its benefits outweigh the potential for harm, and when properly administered! We hear a lot of criticism about the toxicology of EDTA. There is no dispute that if EDTA is given in a dosage 100 times its normal prescription, it is harmful. But the same statement can be about digitalis, diuretics, pain medication, tranquilizers and sedatives, antibiotics, and even aspirin. So, while EDTA is a chemical, drug, it does not often cause side effects and rarely (very rarely) induces a serious toxicity. The same cannot be said for many commonly prescribed medications. For a patient on chelation therapy, experiencing no side effects or toxicity, this is a joy! Halstead cites that in the U.S. from 1970–1980, 100,000 patients received in excess of 2,000,000 treatments of EDTA chelation without any report of significant toxicity. For a "drug," EDTA has certainly demonstrated a very effective record of safety.
One does not measure joy on the basis of escaping pain, however. How does EDTA chelation therapy produce joy? Reversing hardening of the arteries is one sure-fire way. EDTA treatment provides an increase m blood supply and oxygen delivery to tissues throughout the body. Such circulatory rejuvenation improves convalescence during heart attack and stroke; relieves symptoms of transient ischemic attacks (mini-strokes), angina and intermittent claudication of the extremities (pain on walking.) Work published by the International Association of Gerontology and Aging documents EDTA's role in reversing the aging process by altering enzymes in the walls of the artery. Peer review literature in 1981–82 documents significant improvements in circulation through the carotid arteries and coronary arteries following chelation therapy (see Casdorph, H.R. in the Journal of the American Holistic Medical Association.)
Such studies carried out using the state-of-the-art cardiovascular tools via nuclear scanning techniques, defines objective evidence for the role EDTA plays in reversing atherosclerosis. When one can get up and walk several miles without experiencing any pain, this is joy. When one can play and work hard and cease to experience the incapacitating chest pain of angina, this is joy. Regaining memory and concentration thought to be long gone—this is joy. The joy is the change in relationships one shares with others following chelation therapy!
The Men and Women Who Prescribe Chelation
In terms of international medicine in 1982, EDTA chelation therapy is being practiced most openly in the United States. The EDTA treatment is very prominently at what Marilyn Ferguson (author of Aquarius Conspiracy, 1980) terms the leading edge of medical research. Already established as a treatment of atherosclerosis administered according to a medical protocol, it is under close scrutiny by expert researchers in several medical universities. Organizations supporting its use include the American Academy of Medical Preventics in Los Angeles, CA., the International Academy of Preventive Medicine in Kansas, the Northwest Academy of Preventive Medicine in Bellevue, WA, the American Holistic Medical Association in Virginia, and others. University related research was formerly carried out actively by Norman Clarke Sr, M.D., and Norman Clarke Jr, M.D., at the Detroit General Hospital in Detroit, Michigan. More recently John Olwin, M.D., Professor of Surgery at Rush Medical College in Chicago, has investigated chelation therapy. Other investigators performing university research are H. Richard Casdorph, M.D. of Long Beach, CA.; Bruce Halstead, M.D. of Colton, CA.; Lloyd Grumbles, M.D. of Philadelphia, PA. The National Institutes of Health and the American College of Cardiology have been requested by the U.S. Department of Health and Human Services to carry out a well-designed evaluation of EDTA over the next two years. It is appropriate, then, to devote some attention to those individuals prescribing chelation.
Bruce Halstead, M.D. is a premier researcher of marine toxicology. He is the sole author of a three-volume compendium exhaustively detailing the anatomy, physiology, and toxicology of marine organisms. Research exploration has brought him into medical consultation with more than 120 nations, including a rare consulting status with the first Soviet Medical School at Moscow and Vladivlostock. With an esteemed background in toxicology, Bruce Halstead has established a chelating medical practice in Loma Linda and, more recently, in Colton, CA. Halstead states in the preface of his book, The Scientific Basis of EDTA Chelation Therapy, "After having taken an extensive series of EDTA chelation/treatments, and having administered several thousand treatments to others, I have developed a deep appreciation of the clinical value of the therapy."
In Chelation Therapy: How to Prevent or Reverse Hardening of the Arteriesby Dr. Morton Walker, numerous chelating physicians are highlighted. H. Ray Evers, M.D., of Cottonwood, Alabama administered EDTA to Dr. George W. Frankel, M.D., Chief of E.N.T. of two Long Beach, CA, hospitals in 1971. The E.N.T. Chief observed his diabetic ulcers and gangrene clear up under The EDTA Chelation prescribed by Evers. Yiwen Y. Tang, M.D., F.A.B.F.P., of San Francisco, CA, chelated Roland 0. Hohnbaum, D.O., a Richmond, CA, chiropractor in 1975. The photographs of Hohnbaum's feet before and after chelation are clear statements of medical reversal. Vascular surgeons advised Hohnbaum prior to chelation therapy to have his legs amputated. The illustrations reveal the elimination of the diabetic gangrene? The chiropractor was able to return to full-time work. Robert Vance, D.O., of Salt Lake City treated Dean Baxter, an executive of the Atlantic Richfield Oil Company of Houston in 1980. Dean was diagnosed by coronary angiography to have 10% blockage in one heart vessel, 90% blockage in two other major heart vessels. Dean turned down flatly orders given by several heart surgeons of Houston's prestigious bypass surgery centers. Instead, he traveled to Utah and received a series of EDTA chelations. Post chelation radionuclide studies of the heart revealed major improvement of circulatory flow through the formerly blocked vessels. Baxter was given new medical orders to return to full activity and follow-up his dietary modifications. The doctors who ordered bypass surgery could not believe that chelation influenced this improvement! Harold Harper, M.D., of Los Angeles, CA., infused EDTA in a Houston physician suffering a heart attack in 1974. The patient, Lester Tavel, D.O., required electrical shock to restore his heart's rhythm to normalcy, and the heart expanded, filling the chest. Enzymes demarking heart functioning were profoundly abnormal. Following a course of EDTA chelation given by Harper, Dr. Tavel was reexamined and found to have normal heart functioning.
Dr. Morton Walker narrates similar medical reports from chelating physicians Robert Rogers, M.D. of Melbourne. Florida; Sibyl W. Anderson, D.O. of Jenks, Oklahoma; Warren M. Levin, M.D., F.A.A.A.P., New York City; the late Carlos R Lamar, M.D., F.I.C.A., of San Juan, Puerto Rico; Charles Farr M.D., Ph.D., of Norman, Oklahoma; Garry F. Gordon, M.D., of Sacramento, CA; Gus Schreiber, M.D., of Dallas, Texas; Leo J. Bolles, M.D., of Bellevue, WA; William Mauer, M.D., of Zion, Illinois, and more.
One Doctor's Office
Gone the sterile hushed atmosphere of the doctor's office. No more urgent whispered voices of softly-stepping nurses hurrying on nursely errands. Take one moment to visit the office of Dr. Jonathan Collin, M.D., a practicing preventive medicine doctor, in Port Townsend, WA.
You park in front of a restored Victorian home, painted spring-fresh green with leaded windows, a winding brick walkway, and of course, a picket fence. As you pass through the gate, you already begin to relax as you admire the manicured lawn, and feast your eyes on the multi-colored flora. As you near the office door, you hear the hum of excited and happy voices. When you open the door, you are at least prepared for a new experience.
At the front desk reigns Jill, office manager, guru in charge of cheerfulness, decor, and prompt payment of your bill. In a homey room to the left are a couch, recliners, chairs, tables, and lots of good reading. If you have a heart problem, you are likely to spend a lot of time in this room; a not-so-unpleasant idea, considering that here is the source of the happy voices. And why are these folks so happy? After all, they are suffering from a serious and debilitating disease. Perhaps, there is a joy in the experience of receiving EDTA…
Reprinted from Heart Disease In Transition: A Medical Newsletter Written For The Patient