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
It is far different, of course, from the "rational basis"
test used for Fourteenth
Amendment equal protection analysis... Here we require the government
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.
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
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
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 Contents
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.)
Virginia Pharmacy Board v. Virginia Citizens Consumer Council, Inc., 425 U.S. 748 (1976);
96 S. Ct. 1817, 1825
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,
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.