Amicus Brief — United States v. Rutherford

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APR § 1979

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IN THE

Supreme Court of the Unite

QOOCTOBER TERM, 1078

No. 78-605

UNITED STATES OF AMERICA, et al.,

Petitioners,

v.

GLEN L. RUTHERFORD, et al.,

Respondents.

Brief Amicus Curiae of The McNaughton Foundation

of California on Behalf of Robert Stickle,

Steve Gadler, Dorothy Schires and Mrs. Doris Keith

Representing a Class of Cancer Patients

STEPHEN TORNAY

Attorney at Law

1831 Fourth Avenue

San Diego, California 92101

Telephone: (714) 232-7171

Attorney for Amicus Curiae

INTERIM PRINTING & MAILING COMPANY

1105 West MORENA BOULEVARD, SAN DIEGO, CALIFORNIA 92110 — 275-3050

i.

TABLE OF CONTENTS

INTEREST OF AMICUS CURIAE ,,,,.,.....5,

SUMMARY OF ARGUMENT ............00008:

QUESTIONS PRESENTED .............eeeeeee

ARGUMENT

I,

II.

WHETHER THE SAFETY AND EFFEC-

TIVENESS REQUIREMENTS OF THE

FEDERAL FOOD, DRUG AND COSME.-

TIC ACT SHOULD BE APPLIED TO

INJECTABLE LAETRILE INTENDED

FOR USE BY TERMINALLY ILL

CANCER PATIENTS WHEN PROCURED

BY A CERTIFIED LICENSED MEDICAL

FRFERTRETEEE S00 intedenrdiacenereres

WHETHER THE JUDGMENT OF THE

TENTH CIRCUIT COURT OF APPEALS

CAN BE UPHELD BY THE HOLDING OF

THE UNITED STATES DISTRICT COURT

FOR THE WESTERN DISTRICT OF

OKLAHOMA THAT THE DENIAL OF

THE USE BY A TERMINALLY ILL

CANCER PATIENT OF LAETRILE

UNDER THE SUPERVISION OF A

PHYSICIAN INVADES THE PATIENT'S

RIGHT OF PRIVACY ............eceeees

CT 5 ha Gees coeabeeaevenens I¥0 ee neas

16

24

“- ° ii

TABLE OF AUTHORITIES CITED TABLE OF AUTHORITIES CITED (Continued)

Page Page

CASES CASES (Continued)

Doe v. Bolton, 410 U.S. 179 (1978) ...cccccceeees i9 United Statea v, General Research Laboratories,

307 F.Supp. 197 (C.D. Cal. 1078) ..cccccccees 6

Dombrowaki v, Pfister, 380 U.S, 479 (1965) ..... 22

: | United States v, Spectro Fooda Corporation,

Eisenstadt v, Baird, 405 U.S, — (1972) ......5. 19 | Civ, - 76-101 (District N.J, 1976) affirmed in

| ' d ' fas

Holy Trinity Church v, United States, | on a selena 6

BN es cecis er tutcnskccvsasess: 22 sas ar 7 ee

; U.S, v, 250 Jara, ete, of U.S, Fancy Pure Honey,

Loving v. Virginia, 388 U.S. 1 (1967) v....ssie, 19 (D.C. Mich, 1963) 218 F.Supp. 208, affirmed

Olmatead v, United States, 227 U.S, 438 ..,...., 18 B44 Fidd 288 vieiiveseeesseseeneneneneneneens 7

People of the State of California v, Privitera, et al,,

WR Woo rnda cdbadeecar iene 20 TEXTS

* is ; ley 2

Pierce v, Society of Sisters, 268 U.S, 510 (1925) , i9 A Clinical Trial of Laetrile (Amygdalin) in the

Treatment of Advanced Cancer,

Prince v, Massachusetts, 321 U.S, 158 (1944) .,. 19 Dr, Charlea G, Moertel, M.D. oo... cc cece, 11

Roe v, Wade, 410 U.S, 113 (1978) voice ces 19 California Laetrile Report, VBI occ ccs 19

Roe v. Whalen, 429 U.S, B99 wo. cc cece cece eee ees 19 Cancer Facta and Figurea,

American Cancer Society, 1977) .........0055 4

Rutherford v, United States,

399 f.Supp. 1208 (W.D, Okla, 1979), 424 F.Supp. | Sanda, Statutes and Statutory Conatruction

566-168 (WB. GER, EBTHD ce cccccccevescccesr 6,15 (4th ed, 1973), Section 58.04 ...cccccccceeees 22

Rutherford v, United States, 498 F.Supp, 1287 ,, 8,17 Toxie Conatituenta of Plant Food Stuffa,

Pane eee C.H, 5, R. D, Montgomery,

Rutherford v, United States, 582 F.2d 1234 .,,.. 5 Academy Press, 1969 ........csccccccececes 6

Skinner v, Oklahoma, 316 U.S, 535 (1942) ..,... 19

» ie

TABLE OF AUTHORITIES CITED (Continued)

Page

MISCELLANEOUS

California Health and Safety Code,

LE sv ba bin hue Salen ch ee OK bhi a OKON 20

ELE | sn Ga EV ead beens unae snub nshte 20

Supreme Court Rule 42(1) vc. ccccccceeeeeeeeeeees |

21 U.S.C,

SN EE 2. ons woes 0 60 Gad4useN eee 5,9

EN, tbc ic Aweduv ahiod odeeebendeeieds 20

IN THE

Supreme Court of the United States

OCTOBER TERM, 1978

No, 78-605

UNITED STATES OF AMERICA, et al,,

Petitioners,

u,

GLEN L, RUTHERFORD, et al,,

Reapondenta,

Brief of Amicus Curiae of The McNaughton Foundation

of California on Behalf of Robert Stickle,

Steve Gadler, Dorothy Schires and Mrs, Doris Keith

Representing a Class of Cancer Patients

INTEREST OF AMICUS CURIAE

Pursuant to Supreme Court Rule 42(1), thia Amicua Curiae

brief ia submitted on behalf of the class of persona described

as American cancer patienta who have gone to the Republic of

Mexico to receive treatment for cancer including the use of

laetrile, These patienta number in the thousands, One clinic,

Centro Medico Delmar, Tiguana, Mexico, has served in excess

_ -

of 15,500 patients since 1974 and currently is receiving

patients from the United States at the rate of approximately

3,700 new patients annually. Clinica Cydel, Tijuana, Mexico,

has served approximately 3,500 patients since opening its

doors and is receiving patients from the United States at the

approximate rate of 850 new patients annually.

The staff of these facilities reveal that approximately eighty

percent (80%) of the United States patients have come to these

clinics after having been advised that their condition is

terminal, conventional medicine can give them no further

help; they seek treatment with laetrile as a last resort.

Treatment in Mexico by the clinics consists of a special diet,

vitamins, minerals and enzymes; adequate rest and exercise;

injectable and oral laetrile. Radiation therapy, conventional

chemotherapy and surgery are used by these clinics at the

discretion of the clinic’s medical director.

The average stay in Mexico is approximately three weeks.

Some patients stay at motels near the border in San Ysidro,

California, and travel each day to the clinics approximately

ten to fifteen miles away. Some patients stay at motels in

Tijuana or in small bungalows provided by the clinics at a

moderate rate of $14.00 per day for double occupancy. After

approximately three weeks, the patient’s initial course of

treatment has been completed and many of the patients have

improved to the point where they are ready to continue their

treatment at home in the United States. The patient is

supplied with a quantity of laetrile, both injectable and oral,

as is determined by his attending physician. This initial

supply is brought into the United States by the patient upon

i

presentation of the physician’s affidavit and payment of

applicable customs duties.

The vast majority of these returning patients desire to

continue treatment with laetrile at their homes in the United

States. It is at this point that the class of patients in whose

interest this brief is being submitted emerges. Under the

current affidavit system in use they are permitted to obtain

additional supplies upon presentation of the physician’s

affidavit and the appointment of a properly designated agent

for the importation of laetrile. It is this class of patients that

will require appropriate relief from this Honorable Court in

order to continue vheir treatment. The vast majority of these

patients experience varying degrees of relief and benefits.

These patients are generally free from pain without the use of

narcotics; the quality of their lives is improved and the length

extended.

SUMMARY OF ARGUMENT

Amicus concurs in the decision of the Tenth Cir-uit Court of

Appeals but requests that this Court should expand the relief

granted to the class of patients to include laetrile for oral

administration. Whether on the grounds of a determination

that the terms “safety” and “effectiveness” have no meaning

to the terminally ill cancer patient or on the grounds of right

of privacy. Access to laetrile, both intravenous and oral,

should not be denied these patients until the clinical trials to

be conducted under the direction of the National Cancer

Institute, Department of Health, Education and Welfare, have

been completed. Amicus urges the continued use of the current

affidavit system pending the outcome of these clinical trials.

-

QUESTIONS PRESENTED

I.

WHETHER THE SAFETY AND EFFECTIVENESS

REQUIREMENTS OF THE FEDERAL FOOD, DRUG AND

COSMETIC ACT SHOULD BE APPLIED TO INJECTABLE

LAETRILE INTENDED FOR USE BY TERMINALLY ILL

CANCER PATIENTS WHEN PROCURED BY A CERTI-

FIED LICENSED MEDICAL PRACTITIONER.

II.

WHETHER THE JUDGMENT OF THE TENTH CIRCUIT

COURT OF APPEALS CAN BE UPHELD BY THE

HOLDING OF THE UNITED STATES DISTRICT COURT

FOR THE WESTERN DISTRICT OF OKLAHOMA THAT

THE DENIAL OF THE USE BY A TERMINALLY ILL

CANCER PATIENT OF LAETRILE UNDER THE SUPER-

VISION OF A PHYSICIAN INVADES THE PATIENT'S

RIGHT OF PRIVACY.

ay

ARGUMENT

I.

WHETHER THE SAFETY AND EFFECTIVENESS

REQUIREMENTS OF THE FEDERAL FOOD,

DRUG AND COSMETIC ACT SHOULD BE APPLIED

TO INJECTABLE LAETRILE INTENDED FOR USE

BY TERMINALLY ILL CANCER PATIENTS WHEN

PROCURED BY A CERTIFIED LICENSED

MEDICAL PRACTITIONER.

The Federal Food, Drug and Cosmetic Act (Act) defines a

new drug as a drug “not generally recognized by qualified

experts as safe and effective for its intended use,” 21 U.S.C.

321, p. 1.

The decision of the Tenth Circuit Court of Appeals,

Rutherford v. United States, 582 F.2d 1234, held that “as a

matter of law, that the safety and effectiveness requirements

of the statute as now written have no application to

terminally ill cancer patients who desire to take the drug

‘laetrile’ intravenously,” ibid. at page 1237. The Court further

limited the procurement of intravenous injections to persons

who are certified by a medical practitioner to be terminally ill

of cancer.

S

The Tenth Circuit, in effect, continued the relief granted the

patients in the United States District Court on grounds other

than that upon which such relief was based in the District

Court. Unfortunately, the relief limited the acquisition of

laetrile to injectable laetrile.'/

i/ The term laetrile is being used in this brief to avoid any

confusion that might come about by the use of the term amygdalin.

Footnote 1 continued on following page.

x

It is urged by Amicus that the Tenth Circuit was correct in

holding that the Commissioner of Food and Drugs

erroneously applied the Federal Food, Drug and Cosmetic Act

to the distribution of intravenous laetrile to terminally ill

cancer patients. It is strongly suggested that that portion of

the decree which permits only intravenous injections of

Footnote 1 continued

More properly, the subject matter being dealt with before the Court is

the substance amygdalin. Amygdalin is extracted from the kernels of

various fruits, mostly of the prunus species. Amygdalin is extracted

from peach, bitter almond, prune and apricot kernels. The most

available is apricot kernels, thus, most of the amygdalin that is

extracted is extracted from this source. The term lae:rile was first

“coined” by Dr. Ernst T. Krebs, Jr. and is now used interchangeably

with the term amygdalin. There have been several judicial

determinations that have equated laetrile and amygdalin. United

States v. Spectro Foods Corporation, Civ. - 76-101 (District N.J. 1976)

affirmed in part, reversed in part, 544 F.2d 1175 (3rd Cir. 1976);

United States v. General Research Laboratories, 397 F.Supp. 197

(C.D. Cal. 1975); Rutherford v. United States, 399 F.Supp. 1208, 1211

(W.D. Okla. 1979), 424 F.Supp. 105106 (W.D. Okla. 1977).

Cyanogenetic glucocides appear in many foods eaten by man

including cassava, sweet potato, yam, maize and millet, bamboo and

sugar cane, peas and beans (especially lima beans), kernel of

almond, lemon, lime, arple, par, cherry, apricot, prune, peach and

plum, (Toxic Constituents of Plant Food Stuffs, C.H. 5, R.D.

Montgomery, Academy Press, 1969). (Lest wrong impressions be

created by the title of the book “Toxic Constituents of Plant Food

Stuffs,” it should be noted that upon reading the article by R. D.

Montgomery, one would quickly conclude that virtually no danger

exists from ingestion of these food stuffs when eaten in normal

quantities.)

<s

laetrile should be broadened to include laetrile for administra-

tion by oral route.?/

(1) The rationale and basis upon which food, drugs and

cosmetics are regulated is to protect the unwary customers in

vital matters of health. U.S. v. 250 Jars, etc. of U.S. Fancy

Pure Honey, (D.C. Mich. 1963) 218 F.Supp. 208, affirmed 344

F.2d 288. The line of cases that characterize this as the |

2/ The current practice by experienced laetrile physicians in

Mexico is to commence the treatment of cancer patients with high

intravenous doses of laetrile. When the patient’s condition justifies it,

the patient is switched to a mixture of injectable as well as oral

laetrile. This is an integral part of the entire treatment given by these

physicians with laetrile. Undoubtedly, the ruling of the Tenth Circuit

expressed by inference a possible misunderstanding as to the toxicity

of laetrile by oral administration. The same Court also apparently

revealed its unfamiliarity with current clinical practice in the

administration of laetrile. It should be observed at this point that the

route of oral administration presents no danger to the cancer patient

when under the guidance of a licensed physician. Laetrile like any

other substance, can be ingested in toxic quantities but this is true of

many over-the-counter drugs sold without prescription and also of

prescription items. This is not a valid reason to withhold it when

recommended by a physician. The fears expressed by the U.S.

Government and some of the amicus briefs reveal a lack of under-

standing of the toxicity of laetrile. The American Cancer Society has

estimated that as many at 70,000 cancer patients in the United

States have received laetrile therapy. This would, by necessity,

include oral administration. The report of two deaths which are in

themselves suspect and inconclusive leaves much to be desired in

supporting claims of the toxicity of laetrile. It is estimated that as

many as 1200 deaths occur annually in the United States from

ingestion of aspirin. (Center for Disease Control, Atlanta, Georgia.)

Yet aspirin is freely available to anyone who wishes to purchase it.

i

4

rationale behind the act are numerous, repetitious and center

around the attempt to protect the consumer. The requirement

of both safety and effectiveness in new drugs as provided by

the Act is commendable and should be interpreted and

enforced in a rational manner so as to give effect to the under-

lying purpose. Perhaps it is unworthy to say, but a necessary

observation to make, that the safety and effectiveness require-

ments of the Federal Food, Drug and Cosmetic Act as related

to the treatment of cancer is and has been more a statement of

wishful thinking than a reality.

Unfortunately, statistics bear out the fact that virtually all

methods of treatment of capcerous conditions by accepted

modalities are neither “safe” nor “effective.”3/ & 4/

(Footnotes 3 and 4 are quoted from Judge Bohanon’s decision in

Rutherford v. United States, 438 F.Supp. 1287.)

3/ “ . ,. the treatments that are available are very often

disfiguring; they can be painful; they can be unpleasant; they can

even be risky.” Emil J. Freireich, Professor of Medicine at the

University of Texas, School of Medicine, Houston.

4/ 1977 Cancer Facts and Figures by the American Cancer

Society estimates that 1977 will have produced an estimated 690,000

new cancer cases; and that over 54 million Americans now living will

eventually have cancer, whichis one out of every four Americans

living. The pamphlet also states that over the years cancer will strike

in approximately two of every three families, that in the 1970's there

will be an estimated 3.5 million cancer deaths, 6.5 million new cancer

cases, and more than 10 million people under medical care for cancer.

Only about 1/3 of all people who get cancer this year will be alive five

years after treatment, according to the publication.

-9-

It is therefore submitted that exceptions to the safety and

effectiveness requirements of the Food and Drug

Administration have been carved out when dealing with

cancer since drugs that are neither safe nor effective have

been approved.

Safety is described in the brief by the United States by way

of footnote at page 31, footnote 18, ‘(A) a drug is safe when the

expected therapeutic gain justifies the risk entailed in using

it...”, Dr. Theodore G. Klumpp, Chief Drug Division, F.D.A.

June 23, 1941.

Therefore, it appears that safety as a term is used in the

relative context in relation to the risk involved. Effectiveness

relates only to general recognition among “experts qualified

by scientific training and experience to evaluate the safety

and effectiveness of drugs as safe and effective for such

use...”, 21 U.S.C. 321 p. 1.

The foregoing provides little guidance and in the light of the

current methods of treatment for cancer, afford little

assurance to the cancer patient.

The Tenth Circuit Court of Appeals was able to perceive this

within the narrow limitation set forth by that Court. The ,

decision is limited to terminally ill cancer patients and is

further limited to intravenous injections of laetrile procured

by a licensed practitioner. The Court cited no authority fo rits

decision. Perhaps no such authority exists. However, this

Honorable Court has never been bound by authority nor

shackled by precedent. In enacting a statutory scheme of

reguiation such as the Federal Food, Drug.and Cosmetic Act,

Congress can never be expected to spell out conditions for all

- 10-

circumstances that may arise in the complex nature of our

societies. It is for the judiciary, therefore, to sometimes

interpret a statute amidst the realities of life and to base its

decision on grounds of reason and principle apart from

authority.

The Tenth Circuit Court of Appeals in its decision revealed

a depth of understanding of the terminally ill cancer patient’s

problems. The decision should be upheld but it is again

suggested that the Court expand the relief granted to include

access to laetrile in the oral administration form.

(2) The brief filed by the United States and that of two

amicus briefs (Commonwealth of Massachusetts, State of

California) have in greater or lesser degrees claimed inherent

dangers from the use of laetrile due to its toxicity and further

due to its ineffectiveness. Neither isue is properly before the

Court but if unanswered, wrong impressions could be created.

Therefore, a few comments should be made relative to these

two subject matters.

Initially, it should be observed that as of this date (March,

1979) eighteen states in the United States have legalized the’

sale, and/or manufacture, of laetrile within those states.°/

5/ The following states have already legalized laetrile: Arizona,

Alaska, Washington, Oregon, Idaho, Nevada, North Dakota, South

Daketa, Kansas, Oklahoma, Texas, Louisiana, Florida, Illinois,

Indiana, Maryland, New Hampshire, and New Jersey. (Bills have

passed in one house of the State Legislature of the states of Michigan

and Montana.) It is anticipated with reasonable certainty that a

majority of the states will have legalized laetrile within the next year

or two.

. =

Amicus will ask the Court to take judicial notice that the

legislative bodies of each of the several states have hearings

and testimony offered, both pro and con, when considering a

bill involving a substance that has apparently been as

controversial as laetrile. Amicus will further request the Court

to take judicial notice that each of these States, in the exercise

of it(s) respective police powers, is primarily concerned with

the safety, health and welfare of its citizens. Accordingly,

based on this rather overwhelming indication of confidence

as expressed by the legislative bodies of the states footnoted

below, it becomes apparent that the toxicity claims are

appreciably dissipated and the claims of ineffectiveness are

similarly suspect. It is not the purpose or the function of this

brief to delve into the effectiveness or into the safety of laetrile

although on each of these factors, the Court would

undoubtedly find some input useful.

The Court should be informed that currently the prestigious

Mayo Clinic in Rochester, Minnesota, 55901, is designing a

common protocol for the five institutions which have been

selected by the National Cancer Institute, Department of

Health, Education and Welfare, to carry out the forthcoming

clinical trials of laetrile. In a copy of the proposed clinical trial

obtained through the Freedom of Information Act, the

following statement by Dr. Charles G. Moertel, M.D., of the

Mayo Clinic appears as an introductory to the protocol for the

clinical trials.*/

6/ A Clinical Trial of Laetrile (Amygdalin) in the Treatment of

Advanced Cancer

I. Introduction

Laetrile (Amygdalin, Vitamin B-17) is one of the many natural

cyanogenic glycosides. This substance was perhaps first isolated by

Footnote 6 continued on following page.

Fr

Thus, finally, adequate clinical triala are about to be

commenced in which the question of efficacy will soon be

“

Footnote 6 continued

German chemists in 1832 and it was listed in the Merck Index in the

late 19th century with no defined therapeutic indication.

Current use of Laetrile, dating from the early 1950's, can be

ascribed to Dr. Ernest T. Krebs Jr. who theorized 1) Laetrile is.

metabolized by mammalian cells with the release of cyanide, 2)

Detoxification of cyanide by the normal cell occurs promptly,

converting free cyanide to thiocyanate, 3) An enzyme inhibition in

the cancer cell prevents this detoxification and the free cyanide is

therefore allowed to be specifically toxic to the cancer cell.

Animal tumor model studies of Laetrile have been generally stated

to show no antineoplastic activity. Initial studies conducted at

Memorial-Sloan Kettering by Kanematsu Sugiura, however, were

reported as showing delayed appearance and growth of pulmonary

metastasis in a spontaneous breast tumor system. He also claimed

temporary retardation of growth of small primaries, inhibition of

appearance of new tumors, and better health and appearance of

treated mice. Later studies at the same institution conducted by

Franz Schmidt guve results confirming the observations of Sugiura

in one study out of three and this was only at borderline significance.

The other two studies were negative. More recent investigations

directed by Daniel S. Martin, C. Chester Stock, and Elizabeth

Stockert have been uniformly negative. Some of these latter investi-

gations have been blinded and conducted with direct participation

by Doctor Sugiura. A large group of animal studies were also

conducted at the Southern Research Institute and were stated to be

negative, although analyses of these results by some have raised the

question of antitumor activity in one of three dosage levels tested.

Published negative evaluations in animal model systems also

include those of Hill et al (Cancer Res. 36:2102) and Wadinsky

(Cancer Chemother Rep 59:939). It must be concluded that in animal

tumor studies, the effect of Laetrile has probably been negligible.

Toxicity of Laetrile in dosages currently employed for human

cancer is assumed to be minimal, although toxic reactions have

never been systematically observed and recorded. Apparently the

Footnote 6 continued on following page.

1d:

anawered; the queation of efficacy belongs in the clinica not in

the courta,

Footnote 6 continued

only observed side effect is transient hypotension immediately

following injection, and this is exceedingly rare. Nausea and

vomiting have occurred infrequently after oral ingestion and these

symptoms are said to subside with continued use. Animal toxicology

studies of parenterally administered drug indicate that the dosages

currently employed clinically are far below those at which

significant toxic reactions would be anticipated. Toxicology of the

orally administered drug, however, reveals that there are species to

species differences. Though the dose tolerated in dogs is well above

that planned in this study the defined Lethal Dose in the monkey

and the rat is in the order of 2 grams/m?. This is in contrast to the

~ large clinical experience in humans where larger than proposed

doses are prescribed and administered with little to no reported

toxicity.

In the past, consideration of a clinical trial for Laetrile has been

rejected by the medical and scientific community on the basis of

inadequate preclinical evidence of antineoplastic activity. The usual

‘criteria for according a new drug high priority for clinical trial, as

established by both the National Cancer Institute and the Food and

Drug Administration, have included at least a reasonable demon-

stration of antineoplastic activity in animal tumors. Although

complete reliance on rodent tumor experience for admission of drugs

to human clinical trial can be scientifically questioned, such s

general policy seems reasonable in view of the lack of promising

alternative screening procedures for therapeutic activity. A case for

waving this precedent could only be made under exceptional

circumstances, but such circumstances do now seem to exist for

Laetrile. Today in the United States, Laetrile has become one of the

most commonly employed chemotherapeutic agents for the

treatment of cancer. It has been estimated that during 1977 some

2000 American practitioners were involved in administering over

1,000,000 grams of Laetrile per month to over 50,000 patients. From

the standpoint of magnitude of use alone, Laetrile has become a

public health issue of major significance.

Footnote 6 continued on following page.

Amicus, representing the class as set forth at the beginning

of thie brief, would like to briefly touch upon the method by

Footnote 6 continued

Most important with regard to the Laetrile question are the serious

social, economic, political, and legal issues which have surrounded it.

Organized medicine, the American Cancer Society, the National

Cancer Institute, and the Food and Drug Administration, have

previously taken strong stands against the use of Laetrile, but this

stance has not seemed to be acceptable to the general public.

Organized medicine has been depicted as depriving the dying cancer

patient of a harmless treatment that could conceivably provide

palliation, and, even if therapeutically inactive, could provide a

psychologically beneficial placebo effect. Laetrile has become one of

the most popular subject on the news media with heavy coverage in

newspapers, magazines, radio, and television. Prominent United

States Senators and Congressmen have called publically for a re-

evaluation of the Laetrile question and the Senate Subcommittee on

Health has held public hearing regarding Laetrile. On the state level,

Laetrile has been legalized for either human use of manufacture or

both in 17 of the 50 states. Any contention that these actions simply

represented a response to a vocal minority would seem to be

contradicted by a Harris poll in which a nationwide sampling

favored legalization of Laetrile by a strong 53 to 23 percent majority.

Laetrile has been, or is being. considered in 16 cases before Federal

Courts. In those cases which have been decided, the decisions have

overwhelmingly favored Laetrile. Use of Laetrile by the terminal

cancer patient has been made legal through Federal District Court

decision and this decision has been upheld by the Federal Court of

Appeals. This issue is now pending before the United States Supreme

Court. Laetrile is now allowed for treatment of any cancer patient,

requiring only a short form be filled out which states little more than

the patient has cancer and desire such treatment.

Certainly it may be argued that there is a segment of the American

public that will pursue quack treatment regardless of what evidence

is presented to them. The Laetrile issue, however, has clearly gone

far beyond the point of just another quack medicine. Sound, sensible

Americans are obviously confused and they are not convinced by the

Footnote 6 continued on following page.

7a.

which continued use of laetrile can be experienced by the

terminally ill cancer patienta pending the outcome of the

clinical triala about to be commenced,

Certain references have been made to the “affidavit

system.” Briefly, this is a system worked out following the

orders of the United States District Court for the Western

District of Oklahoma following the decision of that Court in

Rutherford v. United States, 499 F.Supp. 1208. In practice, the

system is one in which duly licensed physicians or court

approved foreign physicians, may sign affidavits. Cancer

patients then, with this affidavit in hand, can obtain their

supplies of laetrile as prescribed by their doctor.

Footnote 6 continued

arguments of Laetrile opponents or by the fact that Laetrile has no

activity in experimental animals. Their concern has been overtly

expressed by their elected representatives and by their Federal

Courts. The welfare of this large segment of the American public

cannot be dismissed with the argument that a handful of Laetrile

zealots will never be convinced regardless of evidence.

If Laetrile is indeed worthless and a cruel hoax for the cancer

victim, then the thinking, sensible American citizen should be

presented with convincing evidence that will serve to protect him

against such exploitation. If, on the other hand, the widespread

public acceptance of Laetrile is indicative of some useful palliative

effect, it is even more important that this effect be demonstrated in a

convincing manner.

Considering the scope and impact of the Laetrile issue today, there

would seem to be no reasonable alternative to a therapeutic trial

conducted with objective methodology by experienced clinical cancer

research groups whose results will be credible in the eyes of the

medical community, the communications media, and the American

public.

~ os

Amicus strenuously urges the Court that this system

(affidavit) should be continued pending the outcome of the

clinical tests on laetrile. The thousands of patients that

Amicus represents should not be made exiles from their own

country in order to continue their treatment. By granting the

relief requested, pending completion of the clinical trials of

laetrile by the National Cancer Institute, no conceivable harm

could be caused to the government’s position whereas

irreparable harm could be sustained by the thousands of

patients Amicus represents should the relief requested be

denied and the clinical trials demonstrates the efficacy of

laetrile.

II.

WHETHER THE JUDGMENT OF THE TENTH

CIRCUIT COURT OF APPEALS CAN BE UPHELD

BY THE HOLDING OF THE UNITED STATES

DISTRICT COURT FOR THE WESTERN DISTRICT

OF OKLAHOMA THAT THE DENIAL OF THE USE

BY A TERMINALLY ILL CANCER PATIENT OF

LAETRILE UNDER THE SUPERVISION OF A

PHYSICIAN INVADES THE PATIENT’S RIGHT

OF PRIVACY.

The government argues in its brief that a terminally ill

cancer patient enjoys no constitutional right of privacy which

would protect him against an intrusion by the United States

Government that would deny him access to the drug laetrile.

Three postulates are urged by the government. The first

suggests that (1) laetrile is toxic, the second (2) denies the

constitutional right of the patient to take a particular drug or

. e

class of drugs for medical purposes and the third (3) alleges

that even if such a constitutional right of privacy exists, such

right to use laetrile is outweighed by compelling government

interest in protecting the public health. Amicus contends that

the United States is wrong on all three postulates.

A. The government first urges that laetrile is toxic. It is

interesting to note that the District Court in which

nontoxicity was found is the Court in which the evidence was

reviewed. Questions of toxicity raised the spectre of possible

deaths and the Court was thus entrusted with the sacred task

of ruling on a possible death-dealing substance. The U.S.

District Court for the Western District of Oklahoma,

Rutherford v. United States, 438 F.Supp. 1287, found adequate

proof by people who had actually used laetrile, as opposed to

those who had not, that laetrile indeed was not toxic. The

question of toxicity, properly speaking, is not really before

this Court. The attempt at this late date to make it an issue

before the Court is beyond the scope of this appeal. However,

it would be appropriate to repeat that virtually every drug in

use today is toxic when ingested or administered by other

methods in excessive amounts. When laetrile is prescribed by

an attending physician, it is perfectly safe. It should also be

noted that a finding by the Commissioner that a drug is not

recognized as safe by qualified experts is not a determination

of toxicity. The range of safety does not limit itself to toxicity

but it involves safety in varying degrees. In any event, when

prescribed by a licensed medical practitioner, clearly there is

no danger or the spectre of any harm to any person.

B. Next, the government claims that there is no

constitutional right of privacy to use unproven or ineffective

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drugs. This untenable argument fails to consider the fact that

there are no safe drugs or treatments and there are no

effective drugs or treatments for the care, treatment or

prevention of cancer. Cast in this light, denial of even an

unproven or ineffective drug that gives the terminally ill

cancer patient hope and is taken by him under the guidance of

a physician invades the right of privacy as described by

Justice Brandeis in Olmstead v. United States, 227 U.S. 438,

478:

“(T fhe makers of our Constitution undertook to

secure conditions favorable to the pursuit of

happiness. They recognized the significance of

man’s spiritual nature, of his feelings and of

his intellect. They knew that only a part of the

pain, pleasure and satisfactions of life are to be

found in material things. They sought to

protect Americans in their beliefs, their

thoughts, their emotions and their sensations.

They conferred, as against the government, the

right to be let alone - - the most comprehensive

of rights and the right most valued by civilized

men. To protect, that right, evéry unjustifiable

intrusion by the government upon the privacy

of the individual, whatever the means

employed, must be deemed a violation. . . .”

The cancer patient is left upon the horns of a dilemma; he is

offered either unsafe and ineffective remedies sanctioned by

the Federal Government or a nontoxic naturally occurring

substance which has been present in the diet of man since

before the dawn of history. Faced with these alternatives, the

terminally ill cancer patient has, and understandably, fre-

quently selected laetrile as his method of treatment. Little has

_ e

been said about the improved quality of life that is achieved

by the patient receiving laetrile. Appetite is restored, weight

increases, pain reduces and the patient experiences an

increased sense of well-being. These are the findings of the

California Laetrile Report of 1953. Within the framework of

this circumstance the cancer patients represented by Amicus

assert a right of privacy to make this “important decision.” To

deny him this right is truly an invasion of an area of privacy

that has been long recognized by this Court in case after case.

This Court has recognized that the right of privacy exists in

many areas of our lives. Abortion, Roe v. Wade, 410 U.S. 113

(1973), Doe v. Bolton, 410 U.S. 179 (1973); marriage, Loving v.

Virginia, 388 U.S. 1 (1967); procreation, Skinner v. Oklahoma,

316 U.S. 535 (1942); contraception, Eisenstadt v. Baird, 405

U.S. (1972); family relationships, Prince v. Massachusetts,

321 U.S. 158 (1944); child rearing and education, Pierce v.

Society of Sisters, 268 U.S. 510 (1925). This Court has

described the breadth of the right as “. . . independence in

making certain kinds of important decisions.”’ Roe v. Whalen,

429 U.S. at 599-600. Important decisions are not limited to

those areas in which this Court has formerly found this

fundamental right to exist.

The Government argues at page 60 of its brief, “the right

claimed here of caring for one’s health by obtaining a

particular drug without government hindrance does not fall

into any of those categories.” A failure to fall “into any of

those categories” (former decisions) does not mean that the

right does not exist in other categories. In all probability, it is

partly for this reason that this case is before this Court.

-.

This is a case of first impression before this Court. There

can be little doubt that this decision, one of life and death, is

the type of “important decision” that this Court has

recognized in determining the parameters of the right of

privacy.

Recently the Supreme Court of the State of California, Sup.

Ct. No. CR-32978, ____ Cal.3d ____ (1979), had an opportunity

to rule on the constitutionality of a State Statute (Health and

Safety Code 1707.1) which provides for criminal sanctions to

any person, including a physician, who sells, delivers,

prescribes or administers any drug or device used in the

diagnosis, treatment, alleviation or cure of cancer which has

not been approved by the federal agency (21 U.S.C. Section

355) or by the State Board (Cancer Advisory Council) (Health

and Safety Code Section 1704).

Defendants, convicted under this statute, claimed a right of

privacy in the patient to receive laetrile, the physician

defendant claimed a derivative right from his patients. The

convictions had been reversed by the District Court of

Appeals in California, People of the State of California v.

Privitera, et al., 141 Cal.Rptr. 764, in a decision written by

Judge Robert O. Staniforth holding that both the doctors’ as

well as the patients’ right of privacy had been invaded. This

searching opinion became the opinion of the dissent and was

reprinted in the California Supreme Court. The logical

arguments of Judge Staniforth are barely resistable.

However, the Supreme Court held that the section under

scrutiny (1707.1 of the Health and Safety Code of the State of

California) did bear a reasonable relationship to the

achievement of a legitimate state interest in the health and

safety of its citizens.

- 21 -

It should be carefully pointed out, however, that this

decision is very narrow in its terms dealing strictly with the

constitutionality of the statute in the case under consideration

by that Court. A quotation from this case (with apologies for

lack of the page number) states as follows:

“Defendants can take no comfort in the Court

of Appeals decision for unlike Rutherford

(referring to 582 Fed. 2d, 1234), this case is not

an action on behalf of the class of terminally ill

cancer patients. Whatever may be said in favor

of permitting terminal cancer patients access

to laetrile, there is no indication in the records

that defendants sought to restrict their

activities to that class when prescribing, distri-

buting and administering laetrile. Indeed, the .

record reflects that Dr. Privitera sometimes

neither took a medical history from, nor per-

sonally examined the patients for whom he

prescribed laetrile. The lay defendants, of

course, were not qualified to diagnose cancer,

much less to determine whether a cancerous

condition was ‘terminal.’ ” (Emphasis by

Court)

Thus it would appear that the California Supreme Court did

recognize that terminally ill cancer patients fall within a

totally different class; as to them, the right of privacy might

easily have been found to exist for this class by the same

Court. Certainly this is a reasonable inference.

C. The third argument of the government on the right of

privacy contends that application of the safety and efficacy

requirement of the Food, Drug and Cosmetic Act to laetrile is

a reasonable means of serving a compelling government

- 22 -

interest in protecting the public health. Amicus agrees that

the “safe” and “effective” requirements of the Food, Drug and

Cosmetic Act are reasonable means of serving a compelling

government interest in protecting health. There is no quarrel

here. However, this broad statement is not reasonably related

to the application of laetrile for reasons previously stated. In

Sands, Statutes and Statutory Construction (4th ed. 1973),

Section 58.04, the following statement appears:

“Because of the deeply entrenched commit-

ment of western society and law to the values

of individualism, there is a pervasive

preference for interpretations of doubtful

statutes which favor individual rights. Thus

statutes which impinge on fundamental

freedoms are strictly construed.” Dombrowski

v. Pfister, 380 U.S. 479 (19665).

Also, from Holy Trinity Church v. United States, 143 U.S.

457 at 459 (1891):

“It is a familiar rule, that a thing may be

within the letter of the statute and yet not

within the statute, because not within its spirit,

nor within the intention of its makers . . . This

is not the substitution of the will of the judge

for that of the legislator, for frequently words

of general meaning are used in a statute, words

broad enough to include an act in question, and

yet a consideration of the whole legislation, or

of the circumstances surrounding its enact-

ment, or of the absurd results which follow

from giving such broad meaning to the words,

makes it unreasonable to believe that the legis-

lator intended to include the particular act.”

- 23 -

It must be remembered that the specific subject matter

before this Court is laetrile in its application only to termi-

nally ill cancer patients under the supervision of a licensed

physician. The Tenth Circuit Court’s decision based upon

reason and principle held that “safe and effective” require-

ments have no meaning to terminally ill cancer patients.

Whether the restriction on government regulation of laetrile is

thus obtained on a rule of statutory construction or on the

constitutional grounds of right of privacy makes little

difference to the suffering cancer patient who is told he is

about to die. The relief requested is what is needed.

Cancer patients should not be made “exiles” from thir own

country, they should not be required to go to foreign jurisdic-

tions in order to obtain the laetrile treatment which is a

treatment of their own choice.

Finally, it is worthy to comment and speculate that the

Tenth Circuit Court sensed the constitutional underpinnings

in its decision but indulged in a rule of statutory construction

to avoid the constitutional issue which is now before this

Court. It is urged that a right of privacy exists in a terminally

ill cancer patient to seek and obtain laetrile under the

guidance of his physician for his personal use without

unwarranted interference by the government.

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CONCLUSION

For the reasons set forth in this brief it is respectfully urged

that the Tenth Circuit Court decision should be affirmed, the

relief expanded to include oral laetrile. Amicus recommends

that the affidavit system now in use should be continued

including oral laetrile pending the completion of the clinical

trials under the direction of the National Cancer Institute,

Department of Health, Education and Welfare.

Respectfully submitted,

STEPHEN TORNAY

Attorney for Amicus Curiae