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:Chelation & Cardiovascular-Health: Chelation-agents:
Symptom checklist:
Potential benefits of chelation:
America’s #1 Health Problem The list of symptoms above includes most of the major causes of both disability and death in America today. According to statistics from the American Heart Association 60,000,000 Americans were affected by cardiovascular diseases like hypertension, coronary heart disease, stroke and rheumatic heart disease in 1993 and 954,138 died as a result. In fact, they estimate that 84 percent of all disease caused deaths in this country are the result of the hardening of the arteries. The cost of medical care just for heart disease alone in America is over $40 billion a year, and yet with all this spending, it still takes its toll, accounting for 54.7 percent of all deaths in our country each year. Atherosclerosis, or hardening of the arteries, starts when the inner cellular membrane of the arteries gets damaged by heavy metals or other toxins and lack of optimum levels of Vitamin C and organic sulfur in the blood plasma prevents immediate repair. This damaged area allows low-density lipoproteins (LDL or ‘bad cholesterol’), often present at high levels due to lack of exercise and poor diet, in the plasma cross the endothelial cell layer of the artery at a point where an injury has occurred and are deposited in the subendothelial layer. Monocytes are next attracted to the site of injury, migrating into the subendothelial layer, where they convert to macrophages, engulfing the LDL to become foam cells which form a fatty streak at the injury site. Then platelets, part of the clotting, or damage control system, come to the rescue. They build up a temporary patch and attract substances to bind to them, forming an arterial plaque. The accumulation of foam cells can eventually rupture the endothelial lining causing platelets to aggregate at the site thus forming a fibrous plaque. Platelet growth factor is released, stimulating smooth muscle cell proliferation and the deposition of even more LDL. Smooth muscle cells produce collagen and form a fibrous, collagen-rich cap or plaque over the site. At this stage the plaque contains toxins, cholesterol, lipid particles, and the debris from dead cells, calcium and fibrin. The smooth muscle cell proliferation can also result in an infiltration into the intima of the arterial wall, forming an atheroma (literally, a swelling or ‘tumor’ of the blood vessel wall). If the atheroma continues to enlarge, small blood vessels surrounding it will also rupture and bleed, leading to calcification inside the atheroma. Enlargement of the atheroma also presses inward, narrowing the arterial lumen (opening). Over time, calcium is also deposited in the plaque, acting like a cement to hold the other substances together, just like it does in healthy connective tissues. Ultimately, arterial plaque is like a plaster cast the body produces to strengthen the damaged area of the artery until it has the proper ingredients to repair the damage, including the elimination of the original toxin that started the damage. Note that one of the key ingredients needed to repair the initial damage is Vitamin C. In fact, most animals don’t get atherosclerosis, since they are able to produce vitamin C in their own bodies, while the human body must rely on food and food supplement sources. The only way people can achieve the protective levels of vitamin C produced by animals is to supplement rather high doses of Vitamin C, with the non-acidic poly-ascorbate form (like Triple Ascorbate C) being the best tolerated, absorbed, utilized and retained, especially in high doses. In addition to his intense interest in the role of Vitamin C, Linus Pauling also did work on the role of Lysine as the specific amino acid to which plaque attaches. Providing increased levels of this amino acid in the blood may play a role in the solubilizing and removal of the plaque to permit repair to be completed. Also, lecithin plays a role in maintaining the solubility of the fats after they are pulled off the artery wall so they don’t merely reattach at another site before the liver breaks them down for removal. Chitosan, through its electromagnetic attraction of fats and bile acids is also crucial in the final stage of this elimination chain, as it prevents re-uptake in the lower bowel. This then stimulates the liver to continue utilizing new fats being delivered from the arteries in the production of bile.Diagram Alternatives: You have the right to choose how you want to treat your own body. In order to fully exercise that right, you must be informed about the alternatives and choices that exist. In the landmark case of Union Pacific Ry. v. Botsford, 141 U.S. 250, 251 (1891), the Supreme Court recognized this right of the individual to control his or her own body in stating: “No right is held more sacred, or is more carefully guarded, by the common law than the right of every individual to the possession and control of his own person, free from all restraint or interference of others...” To counterbalance the information you are likely to get from most conventional sources, lets take a fresh look at how America treats cardiovascular disease. Conventional coronary artery bypass surgery (cost: about $35,000) The average mortality rate for CABG (Coronary Arterial By-pass Graft) surgery is 4% to 10%. It also results in a high incidence of disability due to cerebral dysfunction induced during the procedure itself (much of it perhaps from the general anesthesia), as well as kidney failure, heart attacks, strokes, blood clots, permanent brain damage, personality changes and prolonged pain, with serious complications affecting 8%. The technical failure rate for iliac and femoral angioplasties is up to 50%. This is especially significant when you consider that over 400,000 bypasses and other invasive heart operations are performed every year. For all the risk, such conventional treatments only address a few inches of the largest blood vessels that are blocked and 80% of all bypass grafts clog up again within 7 years. And in many patients, the smaller blood vessels are the most severely damaged. Since there are 75,000 miles of these smaller blood vessels in the human body, it makes more sense to use an approach that can clear and maintain all of them. When a vein is transplanted from the leg to the heart in coronary artery bypass surgery, the only benefit over medical therapy ever proven by properly controlled studies is pain relief in a minority of patients. Even this may not be due to the bypass graft itself since the procedure necessarily includes cutting the nerve fibers that transmit pain information from the heart and by reflex may stimulate spasms of the coronary arteries. After ten-years and $24 million, the National Institute of Health (NIH) concluded that bypass had no benefit for most patients compared to drug therapy. There was no statistical increase in either survival or quality of life. No reduction in heart attacks or improvement in work or reacreational abilities. The study funded by taxpayers’ money did not compare the effects of chelation therapy or any non-invasive natural therapies such as exercise, dietary intervention, supplementation or other lifestyle changes. Many people who undergo bypass later have repeat procedures as well. Grafted coronary arteries are more than 10 times as likely to clog up again after 3 years compared with coronary arteries that are not replaced with a graft. Transplants can malfunction or just wind up being smaller than needed, plus other blood vessels may also become filled with plaque. Ten years after surgery, 40% of bypass patients have had grafted vessels close up, plus another 30% have developed further coronary artery narrowing. After bypass, about 30 to 40% need a second operation within 5 years. Even three or more operations is not uncommon. Even by the standards of the medical establishment that promotes bypass, according to a study published in JAMA, only 56% of bypass surgeries are performed for appropriate reasons. In summary, according to Dr. Thomas A. Preston, professor of cardiology at the University of Washington School of Medicine and chief of cardiology at Pacific Medical Center: Coronary-bypass surgery “is the epitome of modern medical technology. Yet, as it is now practiced, its net effect on the nation's health is probably negative.” Balloon angioplasty or ‘roto-rooter’ surgery (cost: about $12,000) These procedures are also risky and invasive, with little hope of long-term benefit. Most importantly, no cardiovascular surgery does anything to correct the underlying terrain or the disease process which continues to do damage throughout the body. Intravenous chelation
therapy: This office procedure typically consists of 20 to 50 infusions (30 average, with some patients needing more than 100), each lasting three to four hours or longer, at least once a week for about 6 weeks to 6 months. This approach benefits every blood vessel in the body and has the advantage of being faster than the oral route. It consists of intravenous infusion of 500 to 1,000 ml of a solution with 50 mg EDTA (ethylene diamine tetraacetic acid) per kilogram of body weight, plus heparin, magnesium chloride, a local anesthetic (to prevent pain at the site of infusion), B-vitamins, and between 4 and 20 grams of vitamin C. The solution is infused slowly for 3 and a half to 4 hours, between one and three times weekly (according to a special issue of the ACAM journal, with a foreward by Linus Pauling). The possible side effects can include minor discomfort, nausea, dizziness, headache and rarely cardiac arrhythmia, tetany, kidney damage, decreased blood clotting, abnormal bleeding, thrombophlebitis, embolism, hypoglycemia, insulin shock, severe vasculitis, autoimmune related hemolytic anemia, dermatitis, pruritus, generalized eczema or clumping of platelets. Contraindications may also include hypocalcemia, kidney impairment, certain allergic conditions, hypoglycemia, blood-clotting problems, congestive heart failure, liver impairment, and tuberculosis. Also, the liver and kidneys need to be working well in order to eliminate the waste products pulled out in chelation (according to Chelation Therapy: Plain Talk, by Robert D. Gutting, published by ACAM). Still, serious side effects occur in less than 0.01% (1 in 10,000 patients) with over 6 million treatments completed on about 700,000 Americans over the last 40 years, making chelation over 300 times safer than bypass. When 19,000 cases of chelation were studied, about 86% showed significant improvement in circulation to the hands and feet. More than 90% of patients benefited after 35+ treatments if they also improved diet, exercise and smoking habits. Only 5% or less showed no clinical evidence of any improvement. The bottom line is that symptoms improve, blood flow increases to stressed organs, use of synthetic medications decreases, and the overall quality of life improves. At worst, even if chelation and other non-surgical therapies do not achieve adequate results, bypass still remains a choice. And any improvement may help the body recover better from the stress of surgery. One concern has been that chelation might overload the kidneys, which must eliminate the heavy metals and other toxins that are mobilized by the treatments. A recent study on 383 patients chelated with EDTA for chronic degenerative diseases showed significant improvement in kidney function following chelation. However, if kidney function is not normal at the outset, intravenous treatments are given more cautiously and with careful monitoring. While it is sometimes argued that not enough double blind studies have been done, the Congressional Office of Technology Assessment (OTA) reports that only 10 to 20 percent of all procedures currently used in medical practices have been shown to be effective by controlled trial. And a pilot double blind study of chelation has already been completed with strongly favorable results. Combine this with the fact that there have been no reported fatalities in this country under the ACAM protocol, and you have every reason to consider a clinical trial of chelation before rushing into surgery. Chelation is one of the mechanisms by which natural substances such as vitamins, minerals and enzymes work. It is a process basic to life itself and goes on naturally in our body at all times. For example, hemoglobin chelates iron, while chlorophyll is virtually identical except that it chelates magnesium. The word is derived from the Greek ‘chele’ which means claw, to describe how a chelator binds a mineral. History of Medical Chelation Chelation’s initial medical use in humans was in World War II when the British used a chelating agent, British Anti-Lewesite (BAL) as an antidote for poison gas. BAL is used in medicine still even now. The most prevalent chelating agent, however, is EDTA. After its discovery in Germany in the 1930’s, EDTA was first patented in the U.S. in 1948 by Frederick Bersworth, a Georgetown University biochemist, to remove lead in cases of toxic lead poisoning. It forms a stable ring structure when it binds to lead or other heavy metals (toxic minerals with a specific gravity over approximately 5.0). EDTA is water-soluble and chelates only metallic ions that are dissolved in water. Physicians using it for this purpose in Detroit with industrial workers suffering from lead poisoning in a battery factory noticed some patients getting better vision, better hearing, decreasing chest pain, walking further and reduction of discomfort related to poor circulation. They reported that the improvements were more likely due to reduced arteriosclerosis rather than the effects of lead detoxification. Shortly thereafter, the U.S. Navy advocated chelation therapy for sailors who had absorbed lead while painting government ships and dock facilities. Physicians then observed that adults receiving EDTA chelation treatments who had atherosclerosis also experienced health improvements: diminished angina, better memory, sight, hearing, sense of smell and increased vigor. A number of physicians then began to treat individuals suffering from occlusive vascular conditions with chelation therapy and reported consistent improvements. Chelation therapy is still the treatment of choice for lead poisoning, often used in children with lead toxicity which can affect learning abilities, bone formation and many other body functions. Today, over 600 American physicians also use chelation therapy for its cardiovascular benefits, but note that the improvements do not normally occur for up to 3 months after a series of treatments is completed and that follow-up treatments may be recommended once or twice a month for long-term maintenance, to sustain improvement and prevent symptoms from recurring. Since 1964, however, despite additional research and documentation of benefits as well as continual refinement of the treatment protocols, chelation in the treatment of cardiovascular disease has remained controversial (i.e. rejected as a treatment option) among conventional heart surgeons (who do however gladly continue to provide surgical alternatives to chelation) and their medical colleagues who prefer to remain accepted by their peers. Possible benefits of chelation to be investigated in addition to heavy metal removal:
Improvements have been reported in:
What is needed scientifically is documented case reports and continued follow-up to show long-term benefits, such as angiograms or ultrasound tests to compare before and after intervention. Oral cardiovascular
nutrition supplements Vitamins like beta carotene B1, B2, B3, B5, B6, B12, PABA, C, and E are frequently recommended for improving cardiovascular nutrition. A good support program should also include minerals like chromium, magnesium, manganese, selenium and zinc. More specific supplement programs may also contain some of the same chelating agents as I.V. chelation therapy (e.g. Vitamin C and EDTA) at about 10% of the cost, since a doctor’s time and office overhead are not involved. The principal advantages of oral chelation, beyond affordability, relate to the convenience of self-administration at home. Some proponents think that oral supplements may be able to reduce the risk of heart attack by as much as 85%. Oral chelation may take about 10 times longer to achieve results compared to I.V. chelation, but when there is time, and especially for purely preventive measures, this may be the best place to start. About 95% of the oral EDTA works to chelate heavy metals in the digestive tract, similar to the effect of Chitosan marine fiber. This prevents re-absorption, a process sometimes referred to in Biological Medicine as ‘toxic ping-pong,’ where the same toxins are recycled over and over between two organs, in this case the liver and the colon. The other 5% of the EDTA, along with most other ingredients, work primarily in the blood vessels and other body tissues to improve circulation, while assisting in detoxification and repair as well as in the reduction of free radical pathology. Absorption of EDTA is increased when taking it on an empty stomach, but this is usually not necessary since its main action orally is in the digestive tract. Richard Passwater, Ph.D. originally coined the term, “oral chelation.” His book “The Chelation Way,” stated, “Orally administered chelation nutrients and pharmaceuticals behave well as disease preventive measures against those many forms of cellular degenerations comprising physical, chemical, thermal, emotional and mental stress in the body. If people living in industrialized Western societies were to apply the principles of preventive oral chelation therapy combined with the chelating benefits of aerobic exercise, it’s likely that the incidence of heart and blood vessel diseases would be cut from 54.7 percent of all deaths each year to one quarter of that figure.” Noted health author, Dr. Morton Walker, says “Of the four books I have written about chelation therapy, information eliciting the greatest response came from readers has been on oral cardiovascular nutrients. People have repeatedly asked me to tell them about anitoxidants and chelating commercial nutrient formulas that they could take on their own . It appears that they want the benefits of chelation therapy, without the monetary expense of the intravenous procedure and without having to spend 3 - 4 hours of time it takes for each treatment - besides the inconvenience of traveling to the chelating physicians who are located at a considerable distance, and the presumed unpleasantness of receiving EDTA through an intravenous feeding tube. From these readers, requests have come to me to investigate the oral formulas and I have done so. Cardiovascular nutritional formulas are among the hottest new products sweeping the health food industry. Commercial nutrient manufacturers are announcing cardiovascular oral programs that are formulated into novel food supplements. They are being especially constructed for cellular renewal, systemic rejuvenation, disease prevention, or as symptomatic remedies and although some have not been assayed by established medical authorities, most of them work well for their purposes. The reason is that these branded preparations are made up of nutritional ingredients with chelation purposes.” (source: Atherosclerosis and Arteriosclerosis by Morton Walker, D.P.M. in Healthworld) What minerals are chelated? Divalent and trivalent minerals, in decreasing order of affinity to EDTA at a normal blood pH of 7.4:
Another mineral that is chelated is arsenic. Chelation of the transition metals, iron and copper, can be beneficial even though they are essential nutrients, because excess levels trigger free radical pathology, similar to that triggered by heavy metals. According to Dr. Cranton, author of Bypassing Bypass, free radical generating forms of iron and copper are released when blood clots form in blocked arteries. These free radicals then oxidize fatty acids to lipid peroxides, which generate a chain reaction called a free radical cascade. These oxidation reactions cause damage to arterial cell-membranes resulting in plaque formation. Normally, iron is chelated by hemoglobin, protecting the body tissues from iron’s potent free-radical generating capacity, but when blood clots form, free ionic iron is released. Ionic iron has two electrons in its outer N orbitals plus 14 electrons in its M shell. That configuration allows ionic iron to accept up to three pairs of electrons from other molecules, oxidizing them in the process, and potentially generating free radicals in the process. As long as one pair of these electrons is left unbound, ionic iron remains highly reactive. When iron is dissolved in water at a pH of 7.0 or more (e.g. plasma at pH 7.4), its three pairs of electrons will bind to three OH groups of the water. The resulting ferric hydroxide is insoluble and precipitates, getting stuck in the arterial site where it was released. To remove this deposit by IV chelation therapy, EDTA chelates two out of the three pairs of electrons, producing a soluble but stable form at pH 7.4 so that it can be mobilized and excreted. Orally, vitamin C works to chelate, dissolve and mobilize iron deposits. In fact, it works so well that people with iron toxicity need to be cautious and start with relatively low doses of vitamin C to begin detoxifying gradually. Cardiovascular nutrition tends to take eight or ten times longer to achieve the observable benefits of IV chelation. That is because greater quantities or chelating agents can be administered through an intravenous infuser than may be swallowed. Elation! may be used for preventive health maintanance or as a nutritional complement before, during and after medical or surgical therapies. Dietary avoidance:
Dietary enhancement through nutritional counseling and increased:
Lifestyle:
Nutrition-Glossary:
History
of Chelation Therapy
from The American College of Advancement in Medicine (ACAM) Position Statement Ethylenediaminetetraacetic acid ("EDTA") is a synthetic amino acid first used in the 1940's for treatment of heavy metal poisoning. It is widely recognized as effective for that use as well as certain others, including emergency treatment of hypercalcemia and the control of ventricular arrhythmias associated with digitalis toxicity. Studies by the National Academy of Sciences/National Research Council in the late 1960's indicated that EDTA was considered possibly effective in the treatment of occlusive vascular disorders caused by arteriosclerosis. Clinical experience with EDTA chelation therapy has convinced substantial numbers of licensed physicians in North America that it is a safe and effective treatment for atherosclerotic vascular disease, as it consistently improves blood flow and relieves symptoms associated with the disease in greater than 80% of the patients treated. As members of the medical profession are generally aware, the pathogenesis of atherosclerotic disease is extraordinarily complex. In its simplest terms, the rationale for its efficacy is that EDTA, in binding ionic metal catalysts and removing them from the body, reduces subsequent abnormal production of oxygen free radical reactive molecules and molecular fragments which react destructively with other molecules. Reference: E. M. Cranton, J. P. Frackelton, Free Radical Pathology in Age-Associated Diseases: Treatment with EDTA Chelation, Nutrition, and Antioxidants, Journal of Advancement in Medicine, Vol. 2, Nos. 1, 2, Spring/Summer, 1989.1 There is now widespread agreement that EDTA removes metallic catalysts which cause excessive oxygen free radical proliferation, thereby reducing pathological lipid peroxidation of cell membranes, DNA, enzyme systems and lipoproteins and allowing the body's natural healing mechanisms to halt and often reverse the disease process. Steinberg, et al., state in the April 6, 1989, New England Journal of Medicine, 1989; 320(14):915-924, concerning Modifications of Low-density Lipoprotein That Increase Its Atherogenicity through free radical peroxidation, "oxidative modification is absolutely dependent on low concentrations of copper or iron in the medium and is therefore completely inhibited by ethylenediaminetetraacetic acid (EDTA)."2 Chelation therapy is considered by the licensed physicians who utilize it to be an effective first step alternative to surgical treatment for atherosclerotic vascular disease in most cases. In the instances where a licensed physician believes that bypass surgery or the interventional cardiac catheterization techniques of thrombolysis and balloon angioplasty are more appropriate, he or she will refer those patients out. These alternatives to chelation therapy though are not without their respective detractors and attendant risks. In September 1978 the Office of Technology Assessment ("OTA"), a branch of the United States Congress, aided by an advisory board composed of leading medical and university school faculty, published a report entitled Assessing the Efficacy and Safety of Medical Technologies. One portion of that report discussed the efficacy and safety of surgery for coronary artery disease, concluding as follows: Coronary artery bypass surgery
is based on a scientific rationale and may be of measurable benefit
to some patients. It is usually performed for angina pectoris and
appears to give substantial relief from symptoms, but the extent to
which this relief is an effect of surgery is not known. Limited studies
suggest that coronary bypass surgery improves life expectancy significantly
for only a small number of patients, with a particular type of coronary
artery disease. Controlled studies have shown no improvement
in life expectancy for patients studied (emphasis added).
Id. at page 44. 3 A more recent article in the New England Journal of Medicine (March 22, 1984) reported upon myocardial infarction and mortality in the coronary artery surgery study (CASS) randomized trial, and summarized as follows in the Abstract: Abstract: There were no statistically significant differences in the survival rate or in the myocardial infarction rate between subgroups of patients randomly assigned to medical and to surgical therapy when they were analyzed according to initial group assignment, number of diseased vessels, or ejection fraction. Therefore, as compared with medical therapy, coronary bypass surgery appears neither to prolong life nor to prevent myocardial infarction in patients who have mild angina or who are asymptomatic after infarction in the five-year period after coronary angiography. (emphasis added) 5 The necessity of heart surgery
and the scheduling of such surgery has undergone substantial criticism
of late by many in the medical community. Despite this criticism,
in 1981 an estimated 110,000 patients underwent bypass surgery. By
1983 the annual number of operations had increased to 191,000, and
by 1989 the number had soared to over 368,000.6 [Coronary-bypass surgery] is heralded by the popular press, aggrandized by our profession, and actively sought by the consuming public. It is the epitome of modern medical technology. Yet, as it is now practiced, its net effect on the nation's health is probably negative. The operation does not cure patients, it is scandalously overused, and its high cost drains resources from other important areas of need. (emphasis added) Fully half of the bypass operations performed in the United States are unnecessary. A decade of scientific study has shown that except in certain well-defined situations, bypass surgery does not save lives or even prevent heart attacks: Among patients who suffer from coronary-artery disease, those who are treated without surgery enjoy the same survival rates as those who undergo open-heart surgery (emphasis added). MD Magazine, Feb. 1995. In an article entitled The Appropriateness of Performing Coronary Artery By-Pass Surgery published by the American Medical Association in JAMA 1988, 260:505-509, the authors report the results of a randomized study conducted to determine the level of judiciousness currently being applied by physicians in performing coronary artery bypass surgery. The authors report that only fifty-six percent (56%) of the surgeries were performed for appropriate reasons. As stated in the abstract to this article, "eliminating the performance of [such] inappropriate procedures may lead to reductions in health care expenditures or to improved patient outcomes." (emphasis added) Balloon angioplasty is an alternative to venous grafting which is enjoying increased popularity among vascular surgeons. Experience with this technique, though, has shown that serious complications, including permanent renal failure, occur in up to 8% of cases and that technical failure rates for iliac and femoral angioplasties occur in up to 50% of cases. (emphasis added)7 Moreover, it must be remembered that both this technique and venous grafting are very point specific, in distinct contrast to chelation therapy, which benefits the entire vascular system. Furthermore, the costs associated with the various treatment modalities are widely disparate. A typical bypass surgery costs the patient in excess of $30,000.00, the usual balloon angioplasty over $12,000.00, and an average course of chelation treatments $3,000.00 to $5,000.00, including ancillary costs. (emphasis added) The scientific rationale of chelation therapy is demonstrated in the before noted article of E. M. Cranton, M.D. and J. P. Frackelton, M.D. As stated in the Abstract: Abstract: Recent discoveries in the field of free radical pathology provide a coherent, unifying scientific basis to explain the many and diverse benefits reported from treatment with EDTA chelation therapy. The free radical concept provides a scientific basis for treatment and prevention of the major causes of disability and death, including arteriosclerosis, dementia, cancer, arthritis and numerous other diseases. EDTA chelation therapy, nutritional supplementation, physical exercise and moderation of health destroying habits all have common therapeutic mechanisms which reduce free radical causes of age-related diseases. (emphasis added) Chelation therapy, like bypass surgery and angioplasty, is based upon a scientific rationale and is of measurable benefit to patients. There is no reason why surgery should be condoned, while chelation therapy is often condemned simply because it has not heretofore undergone large-scale, double-blind, placebo-controlled trials. As elaborated upon in the OTA report, only 10 to 20 percent of all procedures currently used in medical practices have been shown to be efficacious by controlled trial. (emphasis added)8 The efficacy of chelation therapy has been clinically demonstrated to thousands of doctors through positive results in hundreds of thousands of cases where this treatment was utilized. One pilot double blind study has already been completed with strongly favorable results. (emphasis added)9 The safety of this therapy, when properly administered, is not an issue. It is estimated that over 500,000 patients nationally have been safely treated with this therapy by physicians utilizing the protocol developed by the American College for Advancement in Medicine.10 No reported fatalities have occurred in the United States when the ACAM protocol has been followed. Whenever chelation is used in its widely-accepted role to combat lead poisoning, the dosages given even to children are administered much more rapidly than those administered to adults under this protocol. The risks associated with surgical procedures are far greater by comparison. The Food and Drug Administration determined that EDTA chelation therapy was safe prior to approving the Investigational New Drug protocol for the ongoing double-blind placebo-controlled studies. (Emphasis added) It is the treating, clinical physician who is best acquainted with the patient's medical history, examination results, condition and needs. It is the attending physician who is in the best position to assess the condition (medical, socioeconomic, and psychological) of the patient as well as what constitutes the best treatment for the patient. Despite criticism in the form of opinions from physicians who characteristically have never utilized the treatment modality, not a single valid study has ever been shown to support or warrant such distraction. Physician Use of Innovative Therapies As noted earlier in this Position Paper, physicians who utilize chelation therapy are treating atherosclerotic vascular disease in accordance with sound scientific principles, and they should not be discriminated against for using safe and efficacious innovative therapies. When a physician becomes licensed by the state, the physician is recognized by the state as capable of the diagnosis and treatment of any human disease, pain, injury, deformity or other physical or mental condition. Such a licensed physician has the right, and indeed, the ethical duty, to treat a patient as he or she thinks best, within the parameters of his or her professional judgment and with the highest regard for the health and welfare of the public. It has long been held that deference must be given to the state of advancement of the profession at the time of treatment. Whether or not a particular therapy should be undertaken is a decision which should be made by the treating physician, who is in the best position to determine whether EDTA chelation therapy is indicated for a particular patient. In Stuart v. Wilson, 211 F. Supp. 700 (D.C. 1963), aff'd, 371 U.S. 576, it was noted that "the requirements of learning, skill and examination provided by the Texas Medical Practices Act for obtaining a license to practice medicine bear a direct, substantial and reasonable relation to the practice of medicine." It seems incongruous that having demonstrated the required learning and skill, and having passed the examination and obtained a license, a physician should not be permitted to exercise the judgment developed from his experience. Moreover, as one court has described the healing arts, medicine is an inexact science, and eminently qualified physicians may legitimately diverge in their beliefs as to what constitutes the best treatment. However, such a difference does not amount to unprofessional conduct. See Fitzgerald v. Manning, 679 F.2d 341, 347 (4th Cir. 1982). This does not mean that the State is required to give credence to every peculiar theory or school of medicine. "Without doubt, it is reasonable for the State to outlaw witch doctors, voodoo queens, bee-stingers and various other cults, which no reasonably intelligent man would choose for the treatment of his ills." England vs. Bd. of Medical Examiners, 259 F.2d 626, 627 (5th Cir. 1958). Asking rhetorically, "Just where is the dividing line?" The England court held: Under all of the cases, we think it is that the State cannot deny to any individual the right to exercise a reasonable choice in the method of treatment of his ills, nor the correlative right of practitioners to engage in the practice of a useful profession. Id. at 627. The critical question, therefore, is whether or not EDTA chelation therapy is a reasonable choice of treatment modality. Given the fact alone that ACAM's membership of hundreds of doctors nationwide have successfully treated hundreds of thousands of patients with EDTA chelation therapy, it is difficult to fathom how anyone could assert that this treatment is not a reasonable choice of therapy. Merely because a particular method
of treatment is not the method which is "prevailing" does
not support a proposition that the method is ineffective or deceitful.
A review of all of the available medical articles discloses that chelation
therapy is firmly based upon accepted scientific principles and that
both current professional theory and practice have demonstrated the
efficacy of this treatment. The tomato effect in medicine occurs when an efficacious treatment for a certain disease is ignored or rejected because it does not "make sense" in the light of accepted theories of disease mechanism and drug action. The tomato was largely ignored because it was clearly poisonous; it would have been foolish to eat one. In analogous fashion, there have been many therapies in the history of medicine that, while later proved highly efficacious, were at one time rejected because they did not make sense. ...We contend that the tomato effect is in its own way every bit as influential in shaping modern therapeutics as the placebo effect... Recognition of the reality of the tomato effect, while not preventing future errors, may at least help us better understand our mistakes. (emphasis added) It would seem, ...that modern
medicine is particularly vulnerable to the tomato effect. Pharmaceutical
companies have increasingly turned to theoretical over practical arguments
for using their drugs... What is lost in such discussions are the
only three issues that matter in picking a therapy: Does it help?
How toxic is it? How much does it cost? In this atmosphere we are
at risk for rejecting a safe, inexpensive, effective therapy in favor
of an alternative treatment perhaps less efficacious and more toxic,
which is more interesting in terms of our latest views of disease
pathogenesis. In Rogers v. State Board of Medical Examiners, 371 So. 2d 1037 (Fla. App. 1979) aff'd, 387 So. 2d 937 (Fla. 1980), the court discussed the right of the State Board of Medical Examiners to prohibit a physician from administering chelation therapy. Acting Chief Judge Boyer noted that provisions of the Constitution grant a person certain inalienable rights, from which derive the right of a patient to receive, pursuant to a voluntary election, chelation therapy, and in the absence of unlawfulness, harm, fraud, coercion of misrepresentation, the Board was without authority to prohibit the physician from administering such therapy. Id, at 1041. (emphasis added) Utilization of a therapy which is different is not unprofessional or unethical conduct. The converse would also hold true. General acceptance of a therapy does not mean that utilization of that therapy is necessarily professional or competent. Many therapies and treatments thought to be "proper" have now been abandoned as barbaric. The use of alternative means of treatment should not arbitrarily be deemed incompetent care. Time and time again, especially in the field of medicine, experience has taught us that the orthodox view is not necessarily the correct view. As noted by Justice Boyer, and in the concurrence, Justices Melvin and Mills in Rogers, supra (emphasis added): History teaches us that virtually all progress in science and medicine has been accomplished as a result of the courageous efforts of those members of the profession willing to pursue their theories in the face of tremendous odds despite the criticism of fellow practitioners. Copernicus was thought to be a heretic when he theorized that the earth was not the center of the universe. Banishment and prison was the reward for discovery that the world was round. Pasteur was ridiculed for his theory that unseen organisms caused infection. Freud met only resistance and derision in pioneering the field of psychiatry. In our own era chiropractic treatment has been slow in receiving the approval of the other professions of the healing arts. We can only wonder what would have been the condition of the world today and the field of medicine in particular had those in the midstream of their profession been permitted to prohibit continued treatment and therapy and impede progress in those and other fields of science and the healing. Id, at 1041. Any restriction on the use of chelation therapy beyond prescribing conformity with the ACAM protocol is entirely unwarranted. EDTA chelation therapy has long been recognized by a substantial, respected minority of physicians as an acceptable method of treatment, provided that it is administered properly and adheres to the accepted standard of practice. One should not confuse the clear distinction existing between innovative therapy and experimentation. Experimentation has been defined as a procedure with no therapeutic intent, designed to test a hypothesis and/or to develop new knowledge. However, innovative therapy is one which is designed to benefit the individual patient and to manage or solve a particular clinical problem. EDTA has been utilized for nearly 50 years by physicians in this country for various symptoms and ailments. Physicians utilizing EDTA for vascular and other diseases are not intending to generate new knowledge but, rather, to treat the particular needs of the patient with the therapy he or she believes is most appropriate. (emphasis added) The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, established by Congress in 1974, has identified innovative therapies as those designed solely to enhance the well-being of an individual patient, even if such therapies are not approved by a peer group agency. See, DHEW Pub. No. (05)77-0004, 1977. A significant fear in allowing the use of innovative therapies concerns alleged risks to the patient. This is where the physician's intent comes into play. The intent to treat the individual patient's symptoms and needs, not advance the personal goals of the physician, allows the physician to determine the risk-benefit ratios involved. It also causes the physician to follow established protocols in the use of the innovative therapy, which will also protect the needs of the patient. (emphasis added) While experimental research involving humans is subject to federal regulations, the use of innovative therapy is not. There is presently no regulation existing which prohibits or restricts the use of innovative therapies. If every innovative therapy needed prior institutional review board approval, an impossible case load would be created and needed therapies would be delayed to the detriment of the patient. It is for the individual physician to determine whether the risks of a certain therapy are too great for the patient. This decision is to be made in light of alternative therapies and upon review of all relevant studies and literature. There is substantial objective evidence that EDTA chelation therapy is beneficial in the treatment of occlusive arterial disease as well as other diseases. Physicians using EDTA chelation therapy have determined that it is a safe and effective alternative to bypass surgery and other treatments, as demonstrated by the results from independent studies relating to blood flow. An excellent composite of numerous studies dealing with chelation therapy is EDTA Chelation Therapy: A Retrospective Study of 2,870 Patients, found in the Text.11 The authors here chronicle the successful treatment of thousands of patients with chelation therapy. In their conclusion they state "the results of this retrospective analysis suggest that chelation therapy with disodium magnesium EDTA was useful in the therapy of several thousand patients with chronic degenerative, especially cardiovascular, diseases." [This text] contains a series of clinical studies and analyses of other clinical studies that are original publications or republications, all of which are strongly supportive of chelation therapy.12 Clinical studies, scientifically conducted by licensed physicians, must naturally be respected and relied upon in a pioneering area of treatment. It is ACAM's position that the efficacy of chelation therapy is supported better by clinical studies than even bypass surgery. Restriction to FDA Package Insert Guidelines is Inappropriate EDTA was originally approved by the FDA in July 1953 under a version of the Federal Food, Drug and Cosmetic Act which required that the drug be shown "safe", i.e., that the benefits outweigh the risks. In 1962, the Act was amended so that any new drugs must be proven both safe and effective before they could be introduced into interstate commerce. The purpose behind the Act is to keep misbranded drugs out of the channels of interstate commerce. United States v. Evers, 643 F.2d 1043 (5th Cir. 1981). It was clearly not intended to regulate the practice of medicine and was drafted so that nothing in the statute or the regulations thereunder would prevent a physician from prescribing a drug for a purpose for which it had not been specifically approved. Id, at 1048. An unequivocal statement of the Act's policy of noninterference with the discretion of a treating physician was provided by the FDA itself: Once [an approved] new drug is in a local pharmacy after interstate shipment, the physician may, as part of the practice of medicine, lawfully prescribe a different dosage for his patient, or may otherwise vary the condition for use from those approved in the package insert, without informing or obtaining the approval of the Food and Drug Administration. This interpretation of the Act is consistent with the Congressional intent as indicated in the legislative history of the 1938 Act and the Drug Amendments of 1962. Throughout the debate leading to the enactment, there were repeated statements that Congress did not intend the Food and Drug Administration to interfere with medical practice and references to the understanding that the bill did not purport or regulate the practice of medicine as between the physician and the patient. Congress recognized a patient's right to seek civil damages in the Courts if there should be evidence of malpractice, and declined to provide any legislative restrictions upon the medical profession. United States v. Evers, supra, 643 F.2d at 1048, quoting 37 Fed. Reg. 16503 (1972). The Alabama District Court explained a physician's freedom to utilize drugs in a manner not set forth upon the package insert as follows: It is well-recognized that a package insert may not contain the most up-to-date information about a drug and the physician must be free to use the drug for an indication not in the package insert when such usage is part of the practice of medicine and for the benefit of the patient. Hopefully, the physician would welcome a well documented package insert because he finds it useful because the information in it is supported by substantial documented evidence. However, the physician can ascertain from medical literature and from medical meetings new and interesting proposed uses for drugs marketed under package inserts not including the new proposed usages. The package insert's most important educational value derives from the fact that it is a well reviewed, authoritative document. New uses for drugs are often discovered, reported in medical journals and at medical meetings, and subsequently may be widely used by the medical profession. But the Federal Drug Administration does not permit the package insert to be amended to include such uses unless the manufacturer submits convincing evidence to support the change. The manufacturer may not have sufficient commercial interest or financial wherewithal to warrant following the necessary procedures to obtain FDA approval for the additional use of the drug. When physicians go beyond the directions given in the package insert, it does not mean that they are acting illegally or unethically and Congress did not intend to empower the FDA to interfere with medical practice by limiting the ability of physicians to prescribe according to their best judgment (emphasis added). The drug-package insert only sets up guidelines, not parameters, for the use of medication. Many drugs are commonly used in a way not specifically listed on the drug enclosure. It is the physician, not the insert, that decides upon the method of treatment, for it is the physician and not the FDA who is treating the patient. The inserts are meant to impart information, not restrict the practice of medicine by those qualified to practice. Dr. John D. Archer of the American Medical Association, in a JAMA editorial, makes a similar observation: The FDA cannot approve or disapprove of how a legally marketed drug is used by a physician in his practice. The agency approves of what a manufacturer may recommend about uses in its labeling (package insert) and advertising. Failure to recognize this distinction can have various harmful results. The FDA Does Not Approve Uses of Drugs, JAMA, August 24:31, 1984, Vol. 252, No. 8. Furthermore, the Forward to the Physicians Desk Reference states in pertinent part as follows: The FDA has also announced that the FD & C Act "does not, however, limit the manner in which a physician may use an approved drug. Once a product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling." Thus, the FDA states also that "accepted medical practice" often includes drug use that is not reflected in approved drug labeling. Physicians Desk Reference, 46th Ed., Medical Economics Company, 1992. Consititutional Considerations
in Restricting Choice in Medical Treatments Without question, the doctor-patient relationship has evolved in recent history from a state of strong paternalism to the era of self-determination largely existent today. At one time, doctors commanded and decided virtually all treatment options for a patient, with no obligation to consider the patient's values or decisions. The assumption existed that the physician unequivocally knew what was best for his or her patient and that the physician's decisions on the medical benefits or potential harms of a given treatment were dispositive factors in making treatment decisions. In recent history, however, paternalism has given way to an era of patient self-determination as consumers have become aware of treatment alternatives and the fact that different doctors favor different approaches, as well as the potentially profound effects that a treatment decision may involve. Patients are increasingly asserting their right to be intimately involved in the decision-making process. As stated by J. Cardozo in Schloendorff v. Society of New York Hospital, 211 N.Y. 125, 105 N.E. 92, 93 (1914), "every human being of adult years and sound mind has a right to determine what shall be done with his own body." Through its adoption of the doctrine of informed consent, the judicial system has embraced the trend towards respecting the personal convictions and values of the individual. This fact was recited as a truism by the Court in Andrews v. Ballard, 498 F. Supp. 1038, 1048, which stated: [I]t is the inalienable nature
of the right to decide to obtain or reject medical treatment, which
forms the very basis of the requirement, enforced throughout America,
that medical practitioners obtain their patients' informed consent
prior to administering treatment. No right is held more sacred, or is more carefully guarded, by the common law than the right of every individual to the possession and control of his own person, free from all restraint or interference of others, unless by clear and unquestionable authority of law. It has subsequently been held, as a matter not only of state common law but also of Federal constitutional law, that the special nature of the doctor-patient relationship precludes unjustifiable State intrusion with patients' rights to decide independently, with the advice of a physician, to obtain or reject medical treatment. Roe v. Wade, 410 U.S. 113 (1973). See also, Planned Parenthood v. Casey, 112 S.Ct. 2791, 2806 (1992), which provides: It is settled now . . . that the Constitution places limits on a State's right to interfere with a person's most basic decisions about family and parenthood, as well as bodily integrity (citations omitted; emphasis added). This judicial maxim derives from the Due Process Clause of the Fourteenth Amendment, which incorporates most of the Bill of Rights against the States. Id. at 2804. It is firmly established that the First Amendment has a penumbra where privacy is protected from governmental intrusion. Griswold v. Connecticut, 381 U.S. 479, 483 (1965). In Griswold, the Court held that the right to privacy was "no less important than any other right carefully and particularly reserved to the people" and that "a government purpose to control or prevent activities constitutionally subject to State regulation may not be achieved by means which sweep unnecessarily broadly, and thereby invade the areas of protected freedoms." Id. at 485. In Andrews v. Ballard, 498 F. Supp. 1038 (S.D. Tex. 1980), the Court expounded on the right of privacy in dealing specifically within the context of patients' rights to alternative medical treatments. After reviewing the Supreme Court jurisprudence, this court determined that two criteria must be met in order to identify those "decisions which will be recognized as among those that an individual may make without unjustified government interference." Id. at 1046. The court explained "first, they must be personal decisions that must primarily involve one's self or one's family. Second, they must be important decisions." Id. (citations omitted). In deciding if health care decisions among alternative medical therapies satisfied these criteria, the court elaborated: The decision to obtain or reject medical treatment, no less than the decision to continue or terminate pregnancy, meets both criteria. First, [such decisions] are, to an extraordinary degree, intrinsically personal. It is the individual making the decision, and no one else, who lives with the pain and the disease. It is the individual making the decision, and no one else, who must undergo or forego the treatment, and it is the individual making the decision, and no one else, who, if he or she survives, must live with the results of that decision. One's health is a uniquely personal possession. The decision of how to treat that possession is of no less personal nature. Second, it is impossible to discuss the decision to obtain or reject medical treatment without realizing its importance. The decision can either produce or eliminate physical psychological, and emotional ruin. It can destroy one's economic stability. It is, for some, the difference between a life of pain and a life of pleasure. It is, for others, the difference between life and death. Id. at 1046-1047. The Florida Supreme Court has specifically and unanimously upheld chelation therapy as a valid exercise of a physician's right to practice medicine. In State Board of Medical Examiners of Florida v. Rogers, 387 So. 2nd 937 (Fla. 1980) aff'g., 371 So. 2d 1037 (Fla. App. 1979), the Court held that the State Board of Medical Examiners was without authority to deprive a licensed physician's patients of the voluntary election to receive chelation therapy, as the State had not shown the therapy to be harmful. The fact that the therapy was not endorsed by the majority of the medical profession was unpersuasive. The Court observed: Although the State has the power to regulate the practice of Medicine for the benefit of the public health and welfare, this power is not unrestricted. The regulations imposed must be reasonably related to the public health and welfare and must not amount to an arbitrary or unreasonable interference with the right to practice one's profession which is a valuable property right protected by the due process clause. Doe v. Bolton, 410 U.S. 179, 93 S. Ct. 739, 35 L. Ed. 2d 201 (1973); Dent v. West Virginia, 129 U.S. 114, 9 S. Ct. 231, 32 L. Ed. 623 (1889). Under the particular facts of this case, we conclude that the Board's action unreasonably interferes with Dr. Rogers' right to practice medicine by curtailing the exercise of his professional judgment to administer chelation therapy. The record before us fails to evidence harmfulness as a reasonable basis for the Board's action in restricting use of this treatment... The Board's findings do not support a conclusion of quackery, and the State-imposed limitation on the administration of chelation treatment has not been shown by the evidence to have a reasonable relationship to the protection of the health and welfare of the public. Id., at 939-40. See also, Clair v. Centre Comm. Hosp., 317 Pa. Super. 25, 463 A.2nd 1065 (1983); Vest v. Cobb, 76 S.E. 2d 885, 893 (W. Va.). Some states are taking affirmative legislative steps to explicitly safeguard and provide substantial deference to the treating physician's clinical judgment where patient harm is not an issue. In Alaska Code Annotated, Title 8, Chapter 64, Article 2, at Section 08.64.326, it expressly provides in pertinent part: The [Medical] board may not base a finding of professional incompetence solely on the basis that a licensee's practice is unconventional or experimental in the absence of demonstrably physical harm to a patient. Both the House and the Senate of the State of Washington supported a bill proposed by the House Committee on Health Care allowing the use of non-traditional treatment. This bill became law in June 1991. In its House Bill Report, the House Committee stated: The state medical disciplinary board has discriminated against physicians who practice alternative health care, considered non-traditional medicine. Many patients who receive no satisfaction with traditional medical care have gotten relief from physicians who practice under other theories, including holistic medicine. The Board should not discriminate unreasonably against these physicians as long as no harm is being done. Their patients demand a freedom to choose this health care that they believe is best for them, and this freedom is adversely affected by discrimination and harassment from state disciplinary authorities (emphasis added). HOUSE BILL REPORT, at 2 (1991). Of note is that the Washington State Medical Association also supported the enactment of this bill. Similarly, North Carolina amended its medical practice act effective in June 1993 to add the following language: The Board shall not revoke the license of or deny a license to a person solely because of that person's practice of a therapy that is experimental, non-traditional, or that departs from acceptable and prevailing medical practices unless, by competent evidence, the Board can establish that the treatment has a safety risk greater than the prevailing treatment or that the treatment is generally not effective. N.C. Gen. Stat. Section 90-14(a)(6). In recent years, the trend in federal constitutional law is clearly toward greater recognition that the patient's right to a choice of treatment is a fundamental right of privacy. Roe v. Wade, supra; Doe v. Bolton, supra; Planned Parenthood v. Casey, supra; and Andrews v. Ballard, supra. Considerable deference is accorded the patient's determination of what course of treatment to pursue, and there is judicial concern that decisions about personal health care be made by the patient in consultation with his or her physician, free from state regulation. The developments in both state and federal law recognize a "right to be let alone;" i.e., that the final decision among alternative medical treatments - or between treatment and no treatment - belongs to the treated. See, Olmsted v. United States, 277 U.S. 438, 478 (1928). First Amendment Protection of Commercial Speech "[T]he best test of truth is the power of the thought to get itself accepted in the competition of the market..." Abrams v. United States, 250 U.S. 616, 630 (1919) (J. Holmes dissenting). This oft-quoted maxim of First Amendment jurisprudence provides some illumination on the genesis of the First Amendment's application to commercial speech. As stated later by the Supreme Court in the commercial context, "it is the purpose of the First Amendment to preserve an uninhibited marketplace of ideas in which truth will ultimately prevail..." Red Lion Broadcasting Co. v. F.C.C., 395 U.S. 388, 390 (1969); 89 S. Ct. 1794, 1806. "Commercial speech" is defined as that which proposes a commercial transaction. Bd. of Trustees of State Univ. of N.Y. v. Fox, 109 S. Ct. 3028, 3031 (1989). Although the question of whether Justice Holmes' "marketplace of ideas" postulation on free speech extended to the commercial arena was debated for some time, that question was "squarely before" the Court in Virginia Pharmacy Board v. Virginia Citizens Consumer Council, Inc., 425 U.S. 748, 760 (1976); 96 S. Ct. 1817, 1825. In concluding that commercial speech was entitled to protection under the First Amendment, the Court began its analysis with a review of several propositions that were already "settled or beyond serious dispute." It was clear that paid advertisement constituted protected speech. Likewise, speech was protected even though it was carried in a form that was "sold" for profit "and even though it may involve a solicitation to purchase or otherwise pay or contribute money." Id. at 1825. In concluding that commercial speech was entitled to First Amendment protection, the Court reasoned that: As to the particular consumer's interest in the free flow of commercial information, that interest may be as keen, if not keener by far, than his interest in the days most urgent political debate. So long as we preserve a predominantly free enterprise economy, the allocation of our resources in large measure will be made through numerous private economic decisions. It is a matter of public interest that those decisions, in the aggregate, be intelligent and well informed. To this end, the free flow of commercial information is indispensable and if it is indispensable to the proper allocation of resources in a free enterprise system, it is also indispensable to the formation of intelligent opinions as to how that system ought to be regulated or altered. Therefore, even if the First Amendment were thought to be primarily an instrument to enlighten public decision making in a democracy, we could not say that the free flow of information does not serve that goal Id. at 1826-1827. Subsequent decisions have affirmed these principles. See Central Hudson Gas v. Public Service Com'n of N.Y., 447 US 557, 100 S. Ct. 2343, 2349 (1980) ("commercial expression not only serves the economic interest of the speaker, but also assists consumers and furthers the societal interest in the fullest possible dissemination of information"); Discovery Network, Inc. v. City of Cincinnati, 946 F. 2d 464, 469 (6th Cir. 1991), aff'd Cincinnati v. Discovery Network, Inc., 113 S.Ct. 1505, 123 L.Ed. 2d 99 (1993) ("commercial advertising is essential because it conveys information that permits each person to decide which trades and economic decisions are best for that person... As such, commercial speech also has a high value to the society as well"). It is thus unequivocal that commercial speech is protected under the First Amendment. This protection even applies when the speech communicates only an incomplete version of the relevant facts. "The First Amendment presumes that some accurate information is better than no information at all." Bates v. State Bar of Arizona, 433 US 350, 97 S. Ct. 2691, 2704 (1977). No serious argument can be made that the practice of medicine does not involve commerce, consumers, marketing and money. The medical profession clearly involves numerous commercial transactions. Commercial speech is likewise inherently intertwined in the doctor-patient relationship. So long as such speech is not misleading, any state regulation affecting such speech is subject to judicial scrutiny. In Central Hudson Gas v. Public Service Com'n of N.Y. (1980), 447 US 562, 564; 100 S. Ct. 2343, 2350, the Court held that if a commercial speech communication "is neither misleading nor related to unlawful activity," a government regulation burdening such speech must satisfy the following test: The State must assert a substantial interest to be achieved by restrictions on commercial speech. Moreover, the regulatory technique must be in proportion to that interest. The limitation on expression must be designed to carefully achieve the State's goal. Compliance with this requirement may be measured by two criteria. First, the restriction must directly advance the state interest involved; the regulation may not be sustained if it provides only ineffective or remote support for the government's purpose. Second, if the governmental interest could be served as well by a more limited restriction on commercial speech, the excessive restrictions cannot survive. The Central Hudson Court explained that the careful design requirement on such limitations "recognizes that the First Amendment mandates that speech restrictions be "narrowly drawn." Id. at 2351. The Court also pointed out that speech restrictions that posed no danger to the asserted state interest or merely "conditional and remote eventualities" could not justify suppressive regulation. Id. at 2351, 2353. The Court also noted that regulations completely suppressing commercial speech were reviewed with "special care" and that "in recent years this Court has not approved a blanket ban on commercial speech unless the expression itself was flawed in some way, either because it was deceptive or related to unlawful activity. Id. at 2351, n. 9. The narrow tailoring requirement of the Central Hudson Test was further elaborated upon by the Supreme Court in Bd. of Trustees of State Univ. of N.Y. v. Fox (1989), 109 S. Ct. 3028. In Fox , the Court stated that the regulation must not "burden substantially more speech than is necessary to further the government's legitimate interest." Id. at 3034. The Court then explained that: What our decisions require is a "fit" between the legislature's ends and the means chosen to accomplish those ends - a fit that is not necessarily perfect, but reasonable; that represents not necessarily the single best disposition but one whose scope is "in proportion to the interest served," that employs not necessarily the least restrictive means but,... a means narrowly tailored to achieve the desired objective. We reject the contention that the test we have described is overly permissive. It is far different, of course, from the "rational basis" test used for Fourteenth Amendment equal protection analysis... Here we require the government goal to be substantial, and the cost to be carefully calculated. Moreover, since the state bears the burden of justifying its restrictions, it must affirmatively establish the reasonable fit we require (emphasis provided). Id. at 3035. Thus, while the protection of the public health is concededly a substantial interest, the State bears the burden of demonstrating affirmatively that chelation therapy is inefficacious or unsafe if it intends to burden commercial speech on the matter. It is respectively posited that the State cannot succeed in this endeavor, given the safe and tremendously successful experience physicians have had in utilizing this therapy with their patients. Just as with the doctrine of the right of privacy, the underlying rationale with the commercial speech doctrine is simply a recognition that reasonable people are quite capable of deciding for themselves what is best for them. In responding to the Plaintiff's arguments regarding the need to protect the public, the Supreme Court in Virginia Pharmacy Board v. Virginia Citizen's Consumer Counsel, Inc., 96 S.Ct, 1817, 1829 (1976) summarily stated: There is, of course, an alternative to this highly paternalistic approach. That alternative is to assume that this information is not in itself harmful, that people will perceive their own best interests if only they are well enough informed, and that the best means to that end is to open the channels of communication rather than to close them . . . It is precisely this kind of choice, between the dangers of suppressing information, and the dangers of its misuse if it is freely available, that the First Amendment makes for us. Conclusion As is apparent from the foregoing, it is ACAM's position that a more than sufficient quantum of evidence exists to support the use of EDTA chelation therapy as a safe and efficacious treatment modality and, thus, licensed physicians utilizing this therapy should not be impeded in their use of it with their patients. Under the common law, the State may not deny an individual the right to exercise a reasonable choice in medical care, nor the correlative right of licensed practitioners to provide such care, and the United States Constitution precludes unfair burdening of choice in treatment decisions. Under both the Doctrine of the Right of Privacy and the Commercial Speech Doctrine, substantial deference is given to the individual to make important decisions regarding his own body. As recently reiterated by the Supreme Court, "At the heart of [protected] liberty is the right to define one's own concept of existence, of meaning, of the universe, and of the mystery of human life." Planned Parenthood v. Casey, supra, 112 S.Ct. at 2807. ACAM's position as set forth herein is adopted not only for the medical profession, but more importantly, for the individual patients who can benefit from this treatment.
Table of Legal Authorities
Citations
EDTA Chelation vs. Conventional Therapy for Vascular Disease Researchers started to notice EDTA in the days during and after World War II when men who worked in battery factories or painted ships with lead based paint began coming down with lead poisoning. EDTA was found to be extremely effective for removing the lead from the men's bodies, but what really made people sit up and take notice was an apparent reduction in symptoms of heart disease in these men. The first systematic study of EDTA in people with atherosclerosis was published in 1956. When the researchers gave 20 patients with confirmed heart disease a series of 30 IV EDTA treatments, 19 of these patients experienced improvement, as measured by an increase in physical activity. Another study 4 years later in a similar population found that 3 months of EDTA infusions resulted in decreases in the severity and frequency of anginal episodes, reduced use of nitroglycerin (a common anti-angina drug) increased work capacity and improved ECG (electrocardiogram) findings. It soon became clear from these and later studies that EDTA treatments result in progressive and widespread improvement and stabilization of cardiovascular function. This is in contrast to standard treatments, such as angioplasty or CABG (Coronary Arterial By-pass Graft) which instantaneously restore normal function in the few treated arteries, but leave the rest of the body completely untreated (there's every reason to believe that if arteries are clogged in the heart, they're also clogged in other vital organs, like the kidney's and brain). High tech treatments for heart disease, such as angioplasty and CABG (Coronary Arterial By-pass Graft), long hailed as medical breakthroughs, are in fact, oversold, overpriced and ineffective, especially when compared to EDTA Chelation. The truth of this assertion has been demonstrated on numerous occasions over the last 2 decades:
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