Source: https://www.regenmedky.com/chelation-phosphatydil-choline-plaquex-and-heart-disease/
Timestamp: 2019-04-22 14:30:55+00:00

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Chelation therapy is used in selected patients – those with cardiovascular disease. Chelation involves an intravenous infusion of Sodium EDTA (defined below) and other nutrients, given over a 1-1/2 to 3 hour period, weekly 1-2x per week for 20-40 weeks, then once every two weeks for three months, then usually monthly. Chelation has been used for a myriad of diseases with good results /clinical improvement of patients symptoms. These include heart disease, mini-strokes, peripheral arterial disease causing claudication/ leg pain, arthritis, elevated heavy mental toxicity from lead etc. However if one researches the Web, chelation remains controversial in spite of a tremendous amount of both research and clinical experience data proving it is beneficial to patients. The primary reason we use chelation for cardiovascular disease is that patients are able to see and measure the benefit of this therapy by evaluating the effect on their symptoms. Patients, for example, who have angina (chest pain caused by inadequate blood flow to the heart) can tell when the frequency of the pain decreases or stops, or when they can perform certain activities without having their chest pain.
We also use Plaquex (phosphatidyl choline) for cardiovascular problems, generally in conjunction with EDTA. The properties of this material are extraordinary. Phosphatidyl choline is essential for the function of all cell membranes in the body, and supplementation with phosphatidyl choline increases the level and activity of HDL (“good” cholesterol – the one that effectively removes the “bad” cholesterol components from arteries and other areas of deposition). Phosphatidyl choline also enhances liver function, brain and CNS function, and that of many other organs. I am excited about this addition to our treatment regimens! For more information, visit www.Plaquex.com.
We know chelation works for cardiovascular disease and can prove this through beneficial effects experienced by patients, primarily by their relief of cardiovascular symptoms like chest pain, shortness of breath and improved exercise tolerance. Since chelation therapy is a highly charged topic, you may find the following material helpful.
The purpose of this Position Paper is to address and elaborate on questions pertaining to physician administration of EDTA chelation therapy in accordance with ACAM’s protocol. This therapy has been safely and effectively utilized by physicians throughout the nation and hundreds of thousands of patients have received demonstrable benefit from it.
The American College for Advancement in Medicine (“ACAM”) was founded in 1973 as a non-profit corporation and is presently comprised of approximately 750 licensed physicians, many of whom are engaged in the treatment of, or research in, occlusive vascular disease and its related fields. Member physicians study and use innovative and advanced cardiovascular therapies that involve, inter alia, the early detection and identification of risk factors in patients and intensive education in modifying the individual patient’s lifestyle to alter such risk factors. Among the purposes of ACAM are to advance support for and to further research in the application of EDTA chelation therapy and other sound innovative therapies for occlusive vascular disease and degenerative diseases associated with aging. As a professional organization, ACAM presents biannual educational seminars to its membership which qualify for ACCME Category 1 Continuing Medical Education credits.
It is ACAM’s position, as more fully explained in the discussion that ensues, that chelation therapy is a valid and proper course of treatment, based upon scientific rationale, supported by many published clinical studies, and consistent with sound medical practice. Restricting its use by qualified physicians would amount to a wholly unneeded restraint upon the practice of medicine that would adversely affect the standard of medical care available to patients. Such restriction would be contrary to law and a disservice to the public.
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.
As members of the medical profession are generally aware, the pathogenesis of atherosclerotic disease is extraordinarily complex. The scientific principles underlying the efficacy of EDTA chelation therapy in impeding each step of the disease process are beyond the scope of this position paper, but they are elaborated upon in the many published clinical studies and research papers available.
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.
[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. 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.
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. 7Moreover, 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.
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.
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.
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.
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.
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 Chelation 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.
Section II of the 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.
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.
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 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.
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.
[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.
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).
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.
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.
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.).
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.
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).
“[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.
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.
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).
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.
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.
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.

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