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.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.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.

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.

An enlightening article entitled The Tomato Effect-Rejection of Highly Efficacious Therapies was published by the American Medical Association in JAMA, 1984; 251:2387-2390. In this article, Drs. James S. Goodwin and Jean M. Goodwin describe the tomato effect in medicine:

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.

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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. (Emphasis added)

In an age when nearly half of the coronary artery bypass surgeries conducted in the United States are recognized as being conducted for inappropriate reasons and the efficacy of such surgery has been frequently called into question, in contrast to the successful experience physicians have had with chelation, it appears that the "tomato effect" has indeed taken place with chelation therapy. The efficacious use of this therapy in treating arteriosclerosis has been demonstrated in patients world-wide. It is only in recent years that the scientific rationale to explain the benefits of chelation therapy has been elucidated in published research on free radical pathology.

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.

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:

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 arts (emphasis added). 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.

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.