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,
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
recommend about uses in its labeling (package insert) and advertising.
recognize this distinction can have various harmful results.
The FDA Does Not Approve
Uses of Drugs, JAMA, August 24:31, 1984, Vol. 252, No.
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
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
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),
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.