Table of Contents
Preliminary Statement
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.
Introduction
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.
Therapeutic History of Chelation Therapy
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. 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.
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. See, 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
The importance of this analysis is its recognition, though over
70,000 operations were performed in 1977, that the benefits of
such surgery have yet to be demonstrated.4
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.
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
As stated by 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 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.
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."
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.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.
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.
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.