American College for Advancement in MedicineTable of Contents
- Introduction
- Therapeutic History Of Chelation Therapy
- Physician Use Of Innovative Therapies
- Restriction To FDA Package Insert Guidelines Is Inappropriate
- Constitutional Considerations In Restricting Choice Of Medical Treatments
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.
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.
***
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.
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.”
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.
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.
Constitutional Considerations in Restricting Choice in Medical Treatments
The Right of Privacy
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.
It is now well settled that American law generally protects the
patient’s right to choose among licensed practitioners to treat
illnesses and, correspondingly, the right of licensed practitioners
to determine within the scope of their licenses the appropriate
treatment. In the early case of Union Pacific Ry. v. Botsford,
141 U.S. 250, 251 (1891), the Supreme Court recognized the right
of the individual to control his 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, 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.
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.
*ACAM gratefully acknowledges the special contribution of its
counsel, Gregory D. Seeley, Esq.,
of Seeley, Savidge & Ausem in developing this position paper.
Table of Legal Authorities
Abrams v. United States, 250 U.S. 616 (1919)
Andrews v. Ballard, 498 F. Supp. 1038
(S.D. Tex. 1980)
Bates v. State Bar of Arizona, 433 US 350, 97
S. Ct. 2691 (1977)
Bd. of Trustees of State Univ. of N.Y. v.
Fox, 109 S. Ct. 3028 (1989)
Central Hudson Gas v. Public Service Com’n of
N.Y., 447 US 557, 100 S. Ct. 2343 (1980)
Cincinnati v. Discovery Network, Inc., 113 S.Ct.
1505, 123 L.Ed. 2d 99 (1993)
Clair v. Centre Comm. Hosp., 317 Pa. Super. 25, 463 A.2nd 1065 (1983)
Dent v. West Virginia, 129 U.S. 114, 9 S. Ct. 231, 32 L. Ed. 623 (1889)
Discovery Network, Inc. v. City of Cincinnati, 946 F. 2d 464 (6th Cir. 1991)
Doe v. Bolton, 410 U.S. 179, 93 S. Ct. 739, 35 L. Ed. 2d 201 (1973)
Fitzgerald v. Manning, 679 F. 2d 341 (4th Cir. 1982)
Griswold v. Connecticut, 381 U.S. 479 (1965)
Olmsted v. United States, 277 U.S. 438 (1928)
Planned Parenthood v. Casey, 112 S.Ct. 2791 (1992)
Red Lion Broadcasting Co. v. F.C.C., 395 U.S. 388 (1969)
Roe v. Wade, 410 U.S. 113 (1973)
Rogers v. State Board of Medical Examiners, 371 So. 2d 1037 (Fla. App. 1979)
Schloendorff v. Society of New York Hospital, 211 N.Y. 125, 105 N.E. 92, 93 (1914)
State Board of Medical Examiners of Florida v. Rogers, 387 So. 2nd 937 (Fla. 1980)
Stuart v. Wilson, 211 F. Supp. 700 (D.C. 1963)
Union Pacific Ry. v. Botsford, 141 U.S. 250 (1891)
United States v. Evers, 643 F.2d 1043 (5th Cir. 1981)
Vest v. Cobb, 76 S.E. 2d 885 (W. Va.)
1 A copy of this article is contained in the book, “A Textbook on EDTA Chelation Therapy” Journal of Advancement in Medicine, Vol. 2, Nos. 1, 2, Spring/Summer, 1989, pp. 17-54 (hereinafter, this book will be referred to as “Text”). This combined issue is in print and copies are available through Human Sciences Press, Inc., 233 Spring Street, New York,
NY 10013-1578.
2A free radical is defined as any atom or molecule in a particular state with one unpaired electron in outer orbit. The conversion of molecular oxygen to toxic oxygen radicals occurs by single electron transfer by the mitochondrial or microsomal electron transport chain or through oxidant enzyme systems, such as xanthine oxidase, aldehyde oxidase, flavin dehydrogenase, amine oxidase, cycloxygenase and lipooxygenase. See R. A. Hinder, J. H. Stein, Oxygen-Derived Free Radicals, Arch Surg 1991; 126:104-105. This article also refers to the implications of oxygen-derived free radicals in atherosclerosis and other diseases.
3Hereinafter referred to as”OTA Report at p. ___.”
4OTA Report at p. 43.
5Myocardial Infarction and Mortality in the Coronary Artery Surgery Study (CASS) Randomized Trial, N.Eng.J. Med. 1984, 310, No. 12:750-758.
6P. Gundy, Cardiovascular Diseases Remain Nation’s Leading Cause of Death, JAMA 1992; 267:335-336.
7D. M. Widlus, F.A. Osterman, Evaluation and Percutaneous Management of Atherosclerotic Peripheral Vascular Disease, JAMA 1989; 261:3148-3154.
8OTA Report at pp. 60,94.
9E. Olszewer, F. Sabbag, J. Carter, A Pilot Double Blind Study of Sodium-Magnesium EDTA in Peripheral Vascular Disease, published in J. of Natl. Med. Assn., March, 1990.
10Text, supra. n.1, at pp. 269-305.
11See Text, supra n. 3, at pp. 197-211.
12Id, at pp. 107-226.
Jim Strohecker
Daniel Redwood DC