Washington et al v. Sessions et al

Filing 1

COMPLAINT against Charles P. Rosenberg, Jefferson Beauregard Sessions, III, UNITED STATES OF AMERICA, US Department of Justice, United States Drug Enforcement Agency (D.E.A.). (Filing Fee $ 400.00, Receipt Number 0208-13935001)Document filed by Jagger Cotte, Alexis Bortell, Cannabis Cultural Association, Inc., Dean Bortell, Jose Belen, Marvin Washington, Sebastien Cotte. (Attachments: # 1 Exhibit Exhibit 1: Quinnipiac Poll, # 2 Exhibit Exhibit 2: Hemp for Victory, # 3 Exhibit Exhibit 3: Daily News Article, # 4 Exhibit Exhibit 4: Harper's Article, # 5 Exhibit Exhibit 5: Decision, # 6 Exhibit Exhibit 6: Cannabis Patent, # 7 Exhibit Exhibit 7: Ogden Memo, # 8 Exhibit Exhibit 8: Cole Memo, # 9 Exhibit Exhibit 9: FinCen Memo, # 10 Exhibit Exhibit 10: ASA Petition)(Hiller, Michael)

Exhibit 5

UNITED STATES DEPARTMENT OF JUSTICE
Drug Enforcement Administration

)

In The Matter Of

)

)

MARIJUANA RESCHEDULING PETITION

)

Docket No. 86-22

~~~~~~~~~~~~~>

OPINION AND RECOMMENDED RULING, FINDINGS OF
FACT, CONCLUSIONS OF LAW AND DECISION OF
ADMINISTRATIVE LAW JUDGE

FRANCIS L. YOUNG, Administrative Law Judge

APPEARANCES:
KEVIN B. ZEESE, Esq.
ARNOLD S. TREBACH, Esq.
for National Organization For The Reform of
Marijuana Laws
FRANK B. STILWELL, III, Esq.
for Alliance for Cannabis Therapeutics
DAVID C. BECK, Esq.
for Cannabis Corporation of America
CARL ERIC OLSEN, Pro Se
CHARLOTTE J. MAPES, Esq.
MADELEINE R. SHIRLEY, Esq.
for the Government
KARL BERNSTEIN
for National Federation of Parents for Drug-Free Youth
VIRGINIA PELTIER, Esq.
for the International Association of Chiefs of Police
DATED:

SEP 6

1968

CONTENTS
I.

INTRODUCTION

l

II.

RECOMMENDED RULING

7

II I.

ISSUES

7

IV.

STATUTORY REQUIREMENTS FOR SCHEDULING

8

v.

ACCEPTED MEDICAL USE IN TREATEMENT
- CHEMOTHERAPY

10

Findings of Fact
Discussion
VI.

10
26

ACCEPTED MEDICAL USE IN TREATMENT
- GLAUCOMA

35

Findings of Fact
Discussion
VII.

35
38

ACCEPTED MEDICAL USE IN TREATMENT
- MULTIPLE SCLEROSIS, SPASTICITY &
HYPERPARATHYROIDISM

40

Findings of Fact
Discussion
VI II.

40
54

ACCEPTED SAFETY FOR USE UNDER MEDICAL
SUPERVISION

56

Findings of Fact
Discussion
IX.

56
65

CONCLUSIONS AND RECOMMENDED DECISION

67

CERTIFICATION OF SERVICE

69

- i -·

UNITED STATES DEPARTMENT OF JUSTICE
Drug Enforcement Administration

l

In The Matter Of

Docket No. 86-22

)

MARIJUANA RESCHEDULING PETITION

)

~~~~~~~~~~~~~>

OPINION AND RECOMMENDED RULING, FINDINGS OF
FACT, CONCLUSIONS OF LAW AND DECISION OF
ADMINISTRATIVE LAW JUDGE
I•

INTRODUCTION
This is a rulemaking pursuant to the Administrative Procedure Act, 5 U.S.C.
§ 551,

et~··

to determine whether the marijuana plant {Cannabis sativa L)

considered as a whole may lawfully be transferred from Schedule I to Schedule II
of the schedules established by the Controlled Substances Act (the Act), 21

u.s.c.

§ 801,

et~·

None of the parties is seeking to "legalize" marijuana

generally or for recreational purposes.

Placement in Schedule II would mean,

essentially, that physicians in the United States would not violate Federal law
by prescribing marijuana for their patients for legitimate therapeutic purposes.
It is contrary to Federal law for physicians to do this as long as marijuana
remains in Schedule I.
This proceeding had its origins on May 18, lg72 when the National Organization for the Reform of Marijuana Laws (NORML) and two other groups submitted a
petition to the Bureau of Narcotics and Dangerous Drugs (BNDD)l, predecessor
1

The powers and authority granted by the Act to the Attorney General were
delegated to the Director of BNDD and subsequently to the Administrator of
DEA. 28 C.F.R. § 0.100, et~·

agency to the Drug Enforcement Administration (DEA or the Agency), asking that
marijuana be removed from Schedule I and freed of all controls entirely, or be
transferred from Schedule I to Schedule V where it would be subject to only
minimal controls. The Act by its terms had placed marijuana in Schedule I
thereby declaring, as a matter of law, that it had no legitimate use in therapy
in the United States and subjecting the substance to the strictest level of
controls. The Act had been in effect for just over one year when NORML submitted
its lg72 petition.
On September 1, lg72 the Director of BNDD announced his refusal to accept
the petition for filing, stating that he was not authorized to institute proceedings for the action requested because of the provisions of the Single Convention on Narcotic Drugs, 1961. NORML appealed this action to the United States
Court of Appeals for the District of Columbia Circuit. The court held that the
Director had erred in rejecting the petition without "a reflective consideration
and analysis," observing that the Di rector's refusal "was not the kind of agency
action that promoted the kind of interchange and refinement of views that is the
lifeblood of a sound administrative process." NORML v. Ingersoll, 162 U.S. App.
D.C. 67, 497 F.2d 654, 659 (1974). The court remanded the matter in January
1974 for further proceedings not inconsistent with its opinion, "to be denominated a consideration on the merits."

Id.

A three-day hearing was held at DEA2 by Administrative Law Judge Lewis
Parker in January 1975. The judge found in NORML's favor on several issues but
the Acting Administrator of DEA entered a final order denying NORML's petition
"in all respects."
2

NORML again petitioned the court for review. Finding fault

DEA became the successor agency to BNDD in a reorganization carried out
pursuant to Reorganization Plan No. 2 of 1973, eff. July 1, 1973. 38 Fed.
Reg. 15932 (1973).
- 2-

with DEA's final order the court again remanded for further proceedings not
inconsistent with its opinion.
735 (1977).

NORML v. DEA, 182 U.S. App. D.C. 114, 559 F.2d

The Court directed the then-Acting Administrator of DEA to refer

NORML's petition to the Secretary of the Department of Health, Education and
Welfare (HEW) for findings and, thereafter, to comply with the rulemaki11'g> procedures outlined in the Act at 21 U.S.C. § 811 (a) and (b).

~

On remand the Administrator of DEA referred NORML's petition to HEW for
scientific and medical evaluation. On June 4, 1979 the Secretary of HEW advised
the Administrator of the results of the HEW evaluation and recommended that
marijuana remain in Schedule I.

Without holding any further hearing the

Administrator of DEA proceeded to issue a final order ten days later denying
NORML's petition and declining to initiate proceedings to transfer
from Schedule I.

44 Fed. Reg. 36123

(1979)~

marij~ana

NORML went back·to the Court of

Appeals.
When the case was called for oral argument there was discussion of the
then-present status of the matter.

DEA had moved for a partial remand.

The

court found that "reconsideration of all the issues in this case would be appropriate" and again remanded it to DEA, observing: "We regrettably find it necessary to remind respondents [DEA and HEW] of an agency's obligation on remand not
to 'do anything which is contrary to either the letter or spirit of the mandate
construed in the light of the opinion of [the] court deciding the case.'"
(Citations omitted.) NORML v. DEA, et al., No. 79-1660, United States Court of
Appeals for the District of Columbia Circuit, unpublished order filed October
16, 1980. DEA was directed to refer all the substances at issue to the Department of Health and Human Services (HHS), successor agency to HEW,for scien-

- 3 -

tific and medical findings and recommendations on scheduling. DEA did so and
HHS has responded.

In a letter dated April l, 1986 the then-Acting Deputy

Administrator of DEA requested this administrative law judge to commence hearing
procedures as to the proposed rescheduling of marijuana and its components.
After the judge conferred with counsel for NORML and DEA, a notice was
published in the Federal Register on June 24, 1986 announcing that hearings
would be held on NORML's petition for the rescheduling of marijuana and its
components commencing on August 21, 1986 and giving any interested person who
desired to participate the opportunity to do so.

51 Fed. Reg. 22946 (1986).

Of the three original petitioning organizations in 1972 only NORML is a
party to the present proceeding.

In addition the following entities responded

to the Federal Register notice and have become parties, participating to varying
degrees:

the Alliance for Cannabis Therapeutics (ACT), Cannabis Corporation of

America (CCA) and Carl Eric Olsen, all seeking transfer of marijuana to Schedule
II; the Agency, National Federation of Parents for Drug-Free Youth (NFP) and the
International Association of Chiefs of Police (IACP), all contending that
marijuana should remain in Schedule I.
Preliminary prehearing sessions were held on August 21 and December 5,
1986 and on February 20, 1987.3 During the preliminary stages, on January 20,
1987, NORML filed an amended petition for rescheduling.

This new petition aban-

doned NORML's previous requests for the complete de-scheduling of marijuana or
rescheduling to Schedule V.

It asks only that marijuana be placed in Schedule

II•

At a prehearing conference on February 20, 1987 this amended petition was
3 ·Transcripts of these three preliminary prehearing sessions are included in
the record.
- 4-

discussed,4 All parties present stipulated, for the purpose of this proceeding, that marijuana has a high potential for abuse and that abuse of the marijuana plant may lead to severe psychological or physical dependence.

They then

agreed that the principal issue in this proceeding would be stated thus:
Whether the marijuana plant, considered as a whole,5 may
4
The transcript of this prehearing conference and of the subsequent hearing
sessions comprise 15 volumes numbered as follows:

Vol. IV

-

v

-

Cross Examination, January 5, 1988

Vol. VI

-

Cross Examination, January 6, 1988

Vol. I
Vol. II
Vol. III

Vol,

Vol. VII

Prehearing Conference, October 16, 1987
Cross Examination, November 19, 1987
Cross Examination, December 8, 1987
Cross Examination, December 9, 1987

Cross Examination, January 7, 1988

Vol. VIII -

Cross Examination, January 26, 1988

-

Cross Examination, January 27, 1988

Vol. XIII -

Cross Examination, February 4, 1988

-

Cross Examination, February 5, 1988

Vol. IX
Vol.

x

Vol. XI
Vol. XII

Vol. XIV
Vol.

xv

Cross Examination, January 28, 1988
Cross Examination, January 29, 1988
Cross Examination, February 2, 1988

Oral Argument, June 10, 1988

Pages of the transcript are cited herein by volume and page, e.g. "Tr. V-96";
"G-" identifies an Agency exhibit.
5

Throughout this opinion the term "marijuana" refers to "the marijuana pl ant,
considered as a whole".
- 5 -

lawfully be transferred from Schedule I to Schedule II of
the schedules established by the Controlled Substances Act.
Two subsidiary issues were agreed on, as follows:
l. Whether the marijuana plant has a currently accepted
medical use in treatment in the United States, or a
currently accepted medical use with severe restrictions.
2. Whether there is a lack of accepted safety for use of
the marijuana plant under medical supervision.
As stated above , the parties favoring transfer from Schedule I to Schedule II
are NORML, ACT, CCA and Carl Eric Olsen .

Those favoring retaining marijuana in

Schedule I are the Agency , NFP and IACP.
During the Spring and Summer of 1987 the parties identified their witnesses
and put the direct examination testimony of each witness in writing in affidavit
form.

Copies of these affidavits were exchanged.

bled their proposed exhibits and exchanged copies .

Similarly, the parties assemOpportunity was provided for

each party to submit objections to the direct examination testimony and exhibits
proffered by the others . The objections submi tted were considered by the
administrative law judge and ruled on.

The testimony and exhibits not excluded

were admitted into the record. Thereafter hearing sessions were held at which
witnesses were subjected to cross·exami nation.

These sessions were held in New

Orleans, Louisiana on November 18 and 19, 1987; in San Francisco, California on
December 8 and 9, 1987; and in Washington, D.C. on January 5 through 8 and 26
through 29, and on February 2, 4 and 5, 1988. The parties have submi tted proposed findings and conclusions and briefs.
judge on June 10, 1988 in Washington.

- 6 -

Oral arguments were heard by the

II.
RECOMMENDED RULING
It is reco111T1ended that the proposed findings and conclusions submitted by
the parties to the administrative law judge be rejected by the Administrator
except to the extent they are included in those hereinafter set forth,

f~r

the

reason that they are irrelevant or unduly repetitious or not supported by a
preponderance of the evidence.

21 C.F.R. § l316.65(a)(l).
Ill.
ISSUES

As noted above, the agreed issues are as follows:
Principle issue:
Whether the marijuana plant, considered as a whole, may
lawfully be transferred from Schedule I to Schedule II of
the schedules established by the Controlled Substances Act.
Subsidiary issues:
1. Whether the marijuana plant has a currently accepted
medical use in treatment in the United States, or a
currently accepted medical use with severe restrictions.
2.

Whether there is a lack of accepted safety for use of
the marijuana plant under medical supervision.

- 7 -

IV.
STATUTORY REQUIREMENTS FOR SCHEDULING
The Act provides (21

u.s.c.

§ 812(b)) that a drug or other substance may

not be placed in any schedule unless certain specified findings are made with
respect to it.

The findings required for Schedule I and Schedule II are as

follows:
Schedule I. (A) The drug or other substance has a high potential
for abuse.
(B) The drug or other substance has no currently accepted
medical use in treatment in the United States.
·
(C) There is a lack of accepted safety for use of the
drug or other substance under medical supervision.
Schedule II. (A) The drug or other substance has a high potential for
abuse.
(B) The drug or other substance has a currently accepted
medical use in treatment in the United States or a currently
accepted medical use with severe restrictions.
(C) Abuse of the drug or other substances [sic] may lead to
severe psychological or physical dependence.
As noted above the parties have stipulated, for the purpose of this proceeding, that marijuana has a high potential for abuse and that abuse of it may
lead to severe psychological or physical dependence. Thus the dispute between
the two sides in this proceeding is narrowed to whether or not marijuana has a
currently accepted medical use in treatment in the United States, and whether or
not there is a lack of accepted safety for use of marijuana under medical supervision.
The issues as framed here contemplate marijuana's being placed only in
- 8 -

Schedule I or Schedule II.

The criteria for placement in any of the other three

schedules established by the Act are irrelevant to this proceeding.

- 9 -

v.
ACCEPTED MEDICAL USE IN TREATMENT
- CHEMOTHERAPY
With respect to whether or not marijuana has a "currently accepted medical
use in treatment in the United States• for chemotherapy patients. the record
shows the following facts to be uncontroverted.

Findings Of Fact
1. One of the most serious problems experienced by cancer patients
undergoing chemotherapy for their cancer is severe nausea and vomiting caused by
their reaction to the toxic (poisonous) chemicals administered to them in the
course of this treatment. This nausea and vomiting at times becomes 1ife
threatening. The therapy itself creates a tremendous strain on the body.

Some

patients cannot tolerate the severe nausea and vomiting and discontinue treatment.

Beginning in the 1970's there was considerable doctor-to-doctor communi-

cation in the United States concerning patients known by their doctors to be
surreptitiously using marijuana with notable success to overcome or lessen their
nausea and vomiting.
2.

Young patients generally achieve better control over nausea and

vomiting from smoking marijuana than do older patients. particularly when the
older patient has not been provided with detailed information on how to smoke
marijuana.
3. Marijuana cigarettes in many cases are superior to synthetic THC
capsules in reducing chemotherapy-induced nausea and vomiting. Marijuana

- 10 -

cigarettes have an important, clear advantage over synthetic THC capsules in
that the natural marijuana is inhaled and generally takes effect more quickly
than the synthetic capsule which is ingested and must be processed through the
digestive system before it takes effect.
4. Attempting to orally administer the synthetic THC capsule-to a
vomiting patient presents obvious problems - it is vomited right back up''before
it can have any effect.
5. Many physicians, some engaged in medical practice and some teaching
in medical schools, have accepted smoking marijuana as effective in controlling
or reducing the severe nausea and vomiting (emesis) experienced by some cancer
patients undergoing chemotherapy for cancer.
6. Such physicians include board-certified internists, oncologists
and psychiatrists.

(Oncology is the treatment of cancer through the use of

highly toxic chemicals, or chemotherapy.)
7.

Doctors who have come to accept the usefulness of marijuana in

controlling or reducing emesis resulting from chemotherapy have done so as the
result of reading reports of studies and anecdotal reports in their professional
literature, and as the result of observing patients and listening to reports
directly from patients.
8.

Some cancer patients who have acknowledged to doctors that they

smoke marijuana for emesis control have indicated in their discussions that,
although they may have first smoked marijuana recreationally, they accidentally
found that doing so helped reduce the emesis resulting from their chemotherapy.
They consistently indicated that they felt better and got symptomatic relief
from the intense nausea and vomiting caused by the chemotherapy.

- 11 -

These patients

were no longer simply getting high, but were engaged in medically treating their
illness, albeit with an illegal substance. Other chemotherapy patients began
smoking marijuana to control their emesis only after hearing reports that the
practice had proven helpful to ·others. Such patients had not smoked marijuana
recreationally.
9.

This successful use of marijuana has given many cancer chemotherapy

patients a much more positive outlook on their overall treatment, once they were
relieved of the debilitating, exhausting and extremely unpleasant nausea and
vomiting previously resulting from their chemotherapy treatment.
10.

In about December 1977 the previously underground patient practice

of using marijuana to control emesis burst into the public media in New Mexico
when a young cancer patient, Lynn Pearson, began publicly to discuss his use of
marijuana.

Mr. Pearson besought the New Mexico legislature to pass legfslation

making marijuana available legally to seriously ill patients whom it might help.
As a result, professionals in the public health sector in New Mexico more
closely examined how marijuana might be made legally available to assist in
meeting what now openly appeared to be a widely recognized patient need.
11.

In many cases doctors have found that, in addition to suppressing

nausea and vomiting, smoking marijuana is a highly successful appetite stimulant.
The importance of appetite stimulation in cancer therapy cannot be overstated.
Patients receiving chemotherapy often lose tremendous amounts of weight. They
endanger their lives because they lose interest in food and in eating.

The

resulting sharp reduction in weight may well affect their prognosis. Marijuana
smoking induces some patients to eat.
found.

The benefits are obvious, doctors have .

There is no significant loss of weight. Some patients will gain weight.

- 12 -

This allows them to retain strength and makes them better able to fight the
cancer.

Pyschologically, patients who can continue to eat even while receiving

chemotherapy maintain a balanced outlook and are better able to cope with their
disease and its treatment, doctors have found.
12. Synthetic anti-emetic agents have been in existence and utilized
for a number of years. Since about 1980 some new synthetic agents have been
developed which appear to be more effective in controlling and reducing chemotherapy-induced nausea and vomiting than were some of those available in the
1970's. But marijuana still is found more effective for this purpose in some
people than any of the synthetic agents, even the newer ones.
13. By the late 1970's in the Washington, D.C. area there was a growing
recognition among health care professionals and the public that marijuana had
therapeutic value in reducing the adverse effects of some chemotherapy treatments.
With this increasing public awareness came increasing pressure from patients on
doctors for information about marijuana and its therapeutic uses.

Many patients

moved into forms of unsupervised self-treatment. While such self-treatment
often proved very effective, it has certain hazards, ranging from arrest for
purchase or use of an illegal drug to possibly serious medical complications
from contaminated sources or adulterated materials.

Yet, some patients are

willing to run these risks to obtain relief from the debilitating nausea and
vomiting caused by their chemotherapy treatments.
14.

Every oncologist known to one Washington, D.C. practicing inter-

nist and board-certified oncologist has had patients who used marijuana with
great success to prevent or diminish chemotherapy-induced nausea and vomiting.
Chemotherapy patients reporting directly to that Washington doctor that they

- 13 -

have smoked marijuana medicinally vomit less and eat better than patients who do
not smoke it. By gaining control over their severe nausea and vomiting these
patients undergo a change of mood and have a better mental outlook than patients
who, using the standard anti-emetic drugs, are unable to gain such control.
15. The vomiting induced by chemotherapeutic drugs may. last up to four
days following the chemotherapy treatment. The vomiting can be intense, protracted and, in some instances, is unendurable.
vomiting is also deep and prolonged.

The nausea which follows such

Nausea may prevent a patient from taking

regular food or even much water for periods of weeks at a time.
16. Nausea and vomiting of this severity degrades, the quality of life
for these patients, weakening them physically, and destroying the will to fight
the cancer. A desire to end the chemotherapy treatment in order to escape the
emesis can supersede the will to live.

Thus the emesis, itself, can truly be

considered a life-threatening consequence of many cancer treatments. Doctors
have known such cases to occur. Doctors have known other cases where marijuana
smoking has enabled the patient to endure, and thus continue, chemotherapy
treatments with the result that the cancer has gone into remission and the
patient has returned to a full, active satisfying life.
17.

In San Francisco chemotherapy patients were surreptitiously using

marijuana to control emesis by the early l970's.

By 1976 virtually every young

cancer patient receiving chemotherapy at the University of California in San
Francisco was using marijuana to control emesis with great success. The use of
marijuana for this purpose had become generally accepted by the patients and
increasingly by their physicians as a valid and effective form of treatment.
This was particularly true for younger cancer patients, somewhat less common for

- 14 -

older ones.

By 1979 about 25% to 30% of the patients seen by one San Francisco

oncologist were using marijuana to control emesis, about 45 to 50 patients per
year.

Such percentages and numbers vary from city to city.

A doctor in Kansas

City who sees about 150 to 200 new cancer patients per year found that over the
15 yea rs 1972 to 1987 about 5% of the patients he saw, or a tot a1 of abou.t; 75,
used marijuana medicinally.
18.

2

By 1987 marijuana no longer generated the intense interest in the

world of oncology that it had previously, but it remains a viable tool, commonly
employed, in the medical treatment of chemotherapy patients. There has evolved
an unwritten but accepted standard of treatment within the community of oncologists in the San Francisco, California area which readily accepts the use of
marijuana.
19. As of the Spring of 1987 in the San Francisco area, patien'ts
receiving chemotherapy commonly smoked marijuana in hospitals during their treatments.

This in-hospital use, which takes place in rooms behind closed doors,

does not bother staff, is expected by physicians and welcomed by nurses who,
instead of having to run back and forth with containers of vomit, can treat
patients whose emesis is better controlled than it would be without marijuana.
Medical institutions in the Bay area where use of marijuana obtained on the
streets is quite common, although discrete, include the University of California
at San Francisco Hospital, the Mount Zion Hospital and the Franklin Hospital. In
effect, marijuana is readily accepted throughout the oncologic community in the
Bay area for its benefits in connection with chemotherapy. The same situation
exists in other large metropolitan areas of the United States.
20.

About 50% of the patients seen by one San Francisco oncologist

- 15 -

during the year 1987 were smoking marijuana medicinally.

This is about 90 to 95

individuals. This number is higher than during the previous ten years due to
the nature of this physician's practice which includes patients from the "tenderloin" area of San Francisco, many of whom are suffering from AIDS-related
lymphosarcoma. These patients smoke marijuana to control their nausea and
vomiting, not to "get high." They self-titrate, i.e., smoke the marijuana only
as long as needed to overcome the nausea, to prevent vomiting.
21.

The State of New Mexico set up a program in 1978 to.make marijuana

available to cancer patients pursuant to an act of the State legislature. The
legislature had accepted marijuana as having medical use in treatment.

It over-

whelmingly passed this legislation so as to make marijuana available for use in
therapy, not just for research. Marijuana and synthetic THC were given to
patients, administered under medical supervision, to control or reduce emesis.
The marijuana was in the form of cigarettes obtained from the Federal government. The program operated from 1979 until 1986, when funding for it was
terminated by the State. During those seven years about 250 cancer patients in
New Mexico received either marijuana cigarettes ·or THC.

Twenty or 25 physicians

in New Mexico sought and obtained marijuana cigarettes or THC for their cancer
patients during that period.

All of the oncologists in New Mexico accepted

marijuana as effective for some of their patients. At least ten hospitals were
involved in this program in New Mexico, in which cancer patients smoked their
marijuana cigarettes. The hospitals accepted this medicinal marijuana smoking
by patients. Voluminous reports filed by the participating physicians make it
clear that marijuana is a highly effective anti-emetic substance.

It was found

in the New Mexico program to be far superior to the best available conventional

- 16 -

anti-emetic drug, Compazine, and clearly superior to synthetic THC pills. More
than 90% of the patients who received marijuana within the New Mexico program
reported significant or total relief from nausea and vomiting.

Before the

program began cancer patients were surreptitiously smoking marijuana in New
Mexico to lessen or control their emesis resulting from chemotherapy treatments.
They reported to physicians that it was successful for this purpose. Phyticians
were aware that this was going on.
22.

In 1978 the Louisiana legislature became one of the first-State

legislatures in the nation to recognize the efficacy of marijuana in controlling
emesis by enacting legislation intended to make marijuana available by prescription for therapeutic use by chemotherapy patients.

This enactment shows that

there was widespread acceptance in Louisiana of the therapeutic value of marijuana. After a State Marijuana Prescription Review Board was established,
pursuant to that legislation, it became apparent that, because of Federal restrictions, marijuana could be obtained legally only for use in cumbersome, formal
research programs.

Eventually a research program was entered into by the State,

utilizing synthetic THC, but without much enthusiasm, since most professionals
who had wanted to use marijuana clinically, to treat patients, had neither the
time, resources nor inclination to get involved in this limited, formal study.
The original purpose of the Louisiana legislation was frustrated by the Federal
authorities. Some patients, who had hoped to obtain marijuana for medical use
legally after enactment of the State legislation, went outside the law and
obtained it illicitly.

Some physicians in Louisiana accept marijuana as having

a distinct medical value in the treatment of the nausea and vomiting associated
with certain types of chemotherapy treatments.

- 17 -

23.

In 1980 the State of Georgia enacted legislation authorizing a

therapeutic research program for the evaluation of marijuana as a medically
recognized therapeutic substance.

Its enactment was supported by letters from a

number of Georgia oncologists and other Georgia physicians, including the Chief
of Oncology at Grady Hospital and staff oncologists at Emory University Medical
Clinic. Sponsors of the legislation orginally intended the enactment of a law
making marijuana available for clinical, therapeutic use by patients. The bill
was referred to as the "Marijuana-as-Medicine" bill. The final legislation
was crafted, however, of necessity, merely to set up a research program in order
to obtain marijuana from the one legitimate source available - the Federal Government, which would not make the substance available for any purpose other than
conducting a research program. The act was passed by an overwhelming majority in
the lower house of the legislature and unanimously in the Senate.

In January

1983 an evaluation of the program, which by then had had 44 evaluable marijuana
smoking patient-participants, accepted marijuana smoking as being an effective
anti-emetic agent.
24.

In Boston, Massachusetts in 1977 a nurse in a hospital suggested

to a chemotherapy patient, suffering greatly from the therapy and at the point
of refusing further treatment, that smoking marijuana might help relieve his
nausea and vomiting. The patient's doctor, when asked about it later, stated
that many of his younger patients were smoking marijuana. Those who did so
seemed to have less trouble with nausea and vomiting. The patient in question
obtained some marijuana and smoked it, in the hospital, immediately before his
next chemotherapy treatment.

Doctors, nurses and orderlies coming into the room

as he finished smoking realized what the patient had been doing.

- 18 -

None of them

made any comment.

The marijuana was completely successful with this patient,

who accepted it as effective in controlling his nausea and vomiting.

Instead of

being sick for weeks following chemotherapy, and having trouble going to work,
as had been the case, the patient was ready to return to work 48
that chemotherapy treatment.

hour~

after

The patient thereafter always smoked ma,ri j4,ana,

in the hospital, before chemotherapy.

The doctors were aware of it, openly

approved of it and encouraged him to continue, The patient resumed eating
regular meals and regained lost weight, his mood improved markedly, he became
more active and outgoing and began doing things together with his wife that he
had not done since beginning chemotherapy.
25.

During the remaining two years of this patient's life, before his

cancer ended it, he came to know other cancer patients who were smoking
marijuana to relieve the adverse effects of their chemotherapy, Most of these
patients had learned about using marijuana medically from their doctors who,
having accepted its effectiveness, subtly encouraged them to use it.
26.

A Boston psychiatrist and professor, who travels about the country,

has found a minor conspiracy to break the law among oncologists and nurses in
every oncology center he has visited to let patients smoke marijuana before and
during cancer chemotherapy.

He has talked with dozens of these health care

oncologists who encourage their patients to do this and who regard this as an
accepted medical usage of marijuana.

He has known nurses who have obtai.ned

marijuana for patients unable to obtain it for themselves,
27.

A cancer patient residing in Beaverton, Michigan smoked marijuana

medicinally in the nearby hospital where he was undergoing chemotherapy from
early 1979 until he died of his cancer in October of that year.

- 19 -

He smoked it in

his hospital room after his parents made arrangements with the hospital for him
to do so.

Smoking marijuana controlled his post-chemotherapy nausea and vomiting,

enabled him to eat regular meals again with his family, and he became outgoing
and talkative.
helpful.

His parents accepted his marijuana smoking as effective and

Two clergymen, among others, brought marijuana to this patient's home.

Many people at the hospital supported the patient's marijuana therapy, none
doubted its helpfulness or discouraged it. This patient was asked for help by
other patients.

He taught some who lived nearby how to form the marijuana

cigarettes and properly inhale the smoke to obtain relief from nausea and
vomiting. When an article about this patient's smoking marijuana appeared in a
local newspaper, he and his family heard from many other cancer patients who
were doing the same. Most of them made an effort to inform their doctors.

Most

physicians who knew their patients smoked marijuana medicinally approved,
accepting marijuana's therapeutic helpfulness in reducing nausea and vomiting.
28.

In October 1979 the Michigan legislature enacted legislation whose

underlying purpose was to make marijuana available therapeutically for cancer
patients and others.

The State Senate passed the bill 29-5, the House of

Representatives 100-0.

In March 1982 the Michigan legislature passed a

resolution asking the Federal Congress to try to alter Federal policies which
prevent physicians from prescribing marijuana for legitimate medical
applications and prohibit its use in medical treatments.
29.

In Denver, Colorado a teenage cancer patient has been smoking

marijuana to control nausea and vomiting since 1986. He has done this in his
hospital room both before and after chemotherapy.
know he does this.

His doctor and hospital staff

The doctor has stated that he would prescribe marijuana for

- 20 -

this patient if it were legal to do so.
marijuana for the same purpose.

Other patients in the Denver area smoke

This patient's doctor, and nurses with whom he

comes in contact, understand that cancer patients smoke marijuana to reduce or
control emesis.
30.

They accept it.

In late 1980 a three year old boy was brought by his parentjls to a

hospital in Spokane, Washington.
Surgery was performed.

The child was diagnosed as having cancer.

Chemotherapy was begun.

The child became extremely

nauseated and vomited for days after each chemotherapy treatment.
eat regularly.

He lost strength.

He lost weight.

He could not

His body's ability to ward

off common infections, other life-threatening infections, significantly decreased.
Chemotherapy's after-effects caused the child great suffering.
watching parents great suffering.
were tried by the child's doctors.
nausea or vomiting.

They caused his

Several standard, available anti-emetic agents
None of them succeeded in controlling his

Learning of the existence of research studies with THC or

marijuana the parents asked the child's doctor to arrange for their son to be
the subject of such a study so that he might have access to marijuana. The doctor
refused, citing the volume of paperwork and record-keeping detail required in
such programs and his lack of administrative personnel to handle it,
31.

The child's mother read an article about marijuana smoking helping

chemotherapy patients.

She obtained some marijuana from friends,

cookies for her child with marijuana in them.
marijuana in it.

She baked

She made tea for him with

When the child ate these cookies or drank this tea in

connection with his chemotherapy, he did not vomit.
regained lost weight,

His strength returned.

He

His spirits revived. The parents told the doctors and ·

nurses at the hospital of their giving marijuana to their child.

- 21 -

None objected.

They all accepted smoking marijuana as effective in controlling chemotherapyinduced nausea and vomiting. They were interested to see the results of the
cookies.
32.

Soon this child was riding a tricycle in the hallways of the

Spokane hospital shortly after his chemotherapy treatments while other children
there were still vomiting into pans, tied to intervenous bottles in an attempt
to re-hydrate them, to replace the liquids they were vomiting up.

Parents of

some of the other patients asked the parents of this "lively" child how he seemed
to tolerate his chemotherapy so well. They told of the marijuana use. Of those
parents who began giving marijuana to their children, none ever reported back
encountering any adverse side effects.

In the vast majority of these cases, the

other parents reported significant reduction in their children's vomiting and
appetite stimulation as the result of marijuana. The staff, doctors and nurses
at the hospital knew of this passing on of information about marijuana to other
parents.

They approved. They never told the first parents to hi de their son's

medicinal use of marijuana.

They accepted the effectiveness of the cookies and

the tea containing marijuana.
33.
and spread.

The first child's cancer went into remission. Then it returned
Emotionally drained, the parents moved the family back to San

Diego, California to be near their own parents. Their son was admitted to a
hospital in San Diego. The parents informed the doctors, nurses and social
workers there of their son's therapeutic use of marijuana.

No one objected.

The child's doctor in San Diego strongly supported the parent's giving marijuana
to him.

Here in California, as in Spokane, other parents noticed the striking·

difference between their children after chemotherarpy and the first child.

- 22 -

Other parents asked the parents of the first child about it, were told of the
use of marijuana, tried it with their children, and saw dramatic improvement.
They accepted its effectiveness.

"

..

In the words of the mother of the first child:

When your kid is riding a tricycle while his other hospital buddies are

hooked up to IV needles, their heads hung over vomiting buckets, you doif'1t need
a federal agency to tell you marijuana is effective. The evidence is in.front
of you, so stark it cannot be ignored. n6
34.

There is at least one hospital in Tucson, Arizona where medicinal

use of marijuana by chemotherapy patients is encouraged by the nursing staff and
some physicians.
35.

In addition to the physicians mentioned in the Findings above,

mostly oncologists and other practicioners, the following doctors and health
care professionals, representing several di.fferent areas of expertise, accept
marijuana as medically useful in controlling or reducing emesis and testified to
that effect in these proceedings:
a.

George Goldstein, Ph.D., psychologist, Secretary of Health for

the State of New Mexico from 1978 to 1983 and chief administrator in the implementation of the New Mexico program utilizing marijuana;
b Dr. Daniel Danzak, psychiatrist and former head of the New
Mexico program utilizing marijuana;
c.

Dr. Tod Mikuriya, psychiatrist and editor of Marijuana:

Medical Papers, a book presenting an historical perspective of marijuana's
medical use;
d.

Dr. Norman Zinberg, general psychiatrist and Professor of

Psychiatry at Harvard Medical School since 1951;
6

Affidavit of Janet Andrews, ACT rebuttal witness, par. 98.
- 23 -

e.

Dr. John Morgan, psychophannacologist, Board-certified in

Internal Medicine, full Professor and Director of Pharmacology at the City
University of New York;
f.

Dr. Phillip Jobe, neuropsychopharmacologist with a practice in

Illinois and former Professor of Pharmacology and Psychiatry at the Louisiana
State University School of Medicine in Shreveport, Louisiana, from 1974 to 1984;
g.

Dr. Arthur Kaufman, formerly a general practitioner in Maryland,

currently Vice-President of a private medical consulting group involved in the
evaluation of the quality of care of all the U.S. military hospitals throughout
the world, who has had extensive experience in drug abuse treatment and rehabilitation programs;
h.

Dr. J. Thomas Ungerleider, a full Professor of Psychiatry at

the University of California in Los Angeles.with extensive experience in research
on the medical use of drugs;
i.

Dr. Andrew Weil, ethnophannacologist, Associate Director of

Social Perspectives in Medicine at the College of Medicine at the University of
Arizona, with extensive research on medicinal plants; and
j. Dr. Lester Grinspoon, a practicing psychiatrist and Associate
Professor at Harvard Medical School.
36. Certain law enforcement authorities have been outspoken in their
acceptance of marijuana as an antiemetic agent. Robert T. Stephan, Attorney
General of the State of Kansas, and himself a former cancer patient, said of
chemotherapy in his affidavit in this record:

"The treatment becomes a terror."

His cancer is now in remission. He came to know a number of health care
professionals whose medical judgment he respected.

- 24 -

They had accepted marijuana

as having medical use in treatment.

He was elected Vice President of the

National Association of Attorneys General (NAAG) in 1983.

He was instrumental

in the adoption by that body in June 1983 of a resolution acknowledging the
efficacy of marijuana for cancer and glaucoma patients.

The resolution expressed

the support of NAAG for legislation then pending in the Congress to make mari,,.t~

juana available on prescription to cancer and glaucoma patients.
was adopted by an overwhelming margin.

The

re~plution

NAAG's President. the Attorney General

of Montana, issued a statement that marijuana does have accepted medical uses
and is improperly classified at present.

The Chairman of NAAG's Criminal Law

and Law Enforcement Committee, the Attorney General of Pennsylvania. issued a
statement emphasizing that the proposed rescheduling of marijuana would in no
way affect or impede existing efforts by law enforcement authorities to crack
down on illegal drug trafficking.
37.

At least one court has accepted marijuana as having medi.cal use in

treatment for chemotherapy patients.

On January 23. 1978 the Superior Court of

Imperial County. California issued orders authorizing a cancer patient to possess
and use marijuana for therapeutic purposes under the direction of a physician.
Another order authorized and directed the Sheriff of the county to release marijuana from supplies on hand and deliver it to that patient in such form as to be
usable in the form of cigarettes.
38.

During the period 1978-1980 polls were taken to ascertain the

degree of public acceptance of marijuana as effective in treating cancer and
glaucoma patients.

A poll in Nebraska brought slightly over 1,000 responses -

83% favored making marijuana available by prescription. 12% were opposed, 5%
were undecided.

A poll in Pennsylvania elicited 1.008 responses - 83.1% favored

availability by prescription, 12.2% were opposed, 4.7% were undecided.
- 25 -

These

two surveys were conducted by professional polling companies. The Detroit Free
Press conducted a telephone poll in which 85.4% of those responding favored
access to marijuana by prescription.

In the State of Washington the State

Medical Association conducted a poll in which 80%.of the doctors belonging to
the Association favored controlled availability of marijuana for medical
purposes.

Discussion
From the foregoing uncontroverted facts it is clear beyond any question
that many people find marijuana to have, in the words of the Act, an "accepted
medical use in treatment in the United States" in effecting relief for cancer
patients.

Oncologists, physicians treating cancer patients, accept this. Other

medical practitioners and researchers accept this.
accept it.

Medical faculty professors

Nurses performing hands-on patient care accept it.

Patients accept it.

As counsel for CCA perceptively pointed out at oral

argument, acceptance by the patient is of vital importance. Doctors accept a
therapeutic agent or process only if it "works" for the patient.

If the patient

does not accept, the doctor cannot administer the treatment. The patient's
informed consent is vital. The doctor ascertains the patient's acceptance by
observing and listening to the patient. Acceptance by the doctor depends on
what he sees in the patient and hears from the patient.

Unquestionably,

patients in large numbers have accepted marijuana as useful in treating their
emesis. The have found that it "works". Doctors, evaluating their patients,
can have no basis more sound than that for their own acceptance.
Of relevance, also, is the acceptance of marijuana by state attorneys-

- 26 -

general, officials whose primary concern is law enforcement.

A large number of

them have no fear that placing marijuana in Schedule II, thus making it
available for legitimate therapy, will in any way impede existing efforts of law
enforcement authorities to crack down on illegal drug trafficking.
The Act does not specify by whom a drug or substance must be "accepted
[for] medical use in treatment" in order to meet the Act's "accepted" requirement for placement in Schedule II.

Department of Justice witnesses told the

Congress during hearings in 197D preceeding passage of the Act that "the medical
profession" would make this determination, that the matter would be "determined
by the medical community." The Deputy Chief Counsel of BNDD, whose office had
written the bill with this language in it, told the House subcommittee that
"this basic determination • •
ment.

• is not made by any part of the federal govern-

It is made by the medical community as to whether or not the drug has

medical use or doesn't")
No one would seriously contend that these Justice Department witnesses
meant that the entire medical community would have to be in agreement on the
usefulness of a drug or substance.
point of law.

Seldom, if ever, do all lawyers agree on a

Seldom, if ever, do all doctors agree on a medical question.

How many are required here? A majority of 51%?

It would be unrealistic to

attempt a plebescite of all doctors in the country on such a question every time
it arises, to obtain a majority vote.
In determining whether a medical procedure utilized by a doctor is
actionable as malpractice the courts have adopted the rule that it is acceptable

7

Drug Abuse Control Amendments - 1970: Hearings on H.R. 11701 and H.R. 13743
Before the Subcommittee on Public Health and Welfare of the House Committee
on Interstate and Foreign Co11111erce, 9lst Congress, 2d Sess. 678, 696, 718
(1970) (Statement of John E. Ingersoll, Director, BNDD).
- 27 -

for a doctor to employ a method of treatment supported by a respectable minority
of physicians.
In Hood v. Phillips, 537

s.w.

2d 291 (1976) the Texas Court of Civil

Appeals was dealing with a claim of medical malpractice resulting from a
surgical procedure claimed to have been unnecessary. The court quoted from an
Arizona court decision holding that
a method of treatment, as espoused and used by ••• a
respectable minority of physicians in the United States,
cannot be said to be an inappropriate method of treatment or to be malpractice as a matter of law even though
it has not been accepted as a proper method of treatment
by the medical profession generally.
Ibid.

at 294.

Noting that the Federal District court in the Arizona case found

a "respectable minority" composed of sixty-five physicians throughout the United
States, the Texas court adopted as "the better rule" to apply in its case, that
a physician is not guilty of malpractice where the
method of treatment used is supported by a respect·
able minority of physicians.
Ibid.
In Chumbler v. McClure, 505 F.2d 48g (6th Cir. 1974) the Federal courts
were dealing with a medical malpractice case under their diversity jurisdiction,
applying Tennessee law. The Court of Appeals said:
••• The most favorable interpretation that may be
placed on the testimony adduced at trial below is
that there is a division of opinion in the medical
profession regarding the use of Premarin in the Treatment of cerebral vascular insufficiency, and that Dr.
McClure was alone among neurosurgeons in Nashville in
using such therapy. The test for malpractice and for
community standards is not to be determined solely by
a plebiscite. Where two or more schools of thought
exist among competent members of the medical profession concerning proper medical treatment for a given
ailment, each of which is supported by responsible

- 28 -

medical authority, it is not malpractice to be among
the minority in a given city who follow one of the
accepted schools.
SOS F.2d at 492 (Emphasis added). See, also, Leech v. Bralliar, 27S F.Supp.
897 (D.Ariz., 1967).
How do we ascertain whether there exists a school of thought

suppo~,.ed

by

responsible medical authority, and thus "accepted"? We listen to the
physicians.
The court and jury must have a standard measure
which they are to use in measuring the acts of a
doctor to determine whether he exercised a reasonable
degree of care and skill; they are not permitted to
set up and use any arbitrary or artificial standard
of measurement that the jury may wish to apply. The
proper standard of measurement is to be established
by testimony of physicians, for it is a medical
question.
Hayes v. Brown, 133 S.E. 2d. 102(Ga., 1963) at lOS.
As noted above, there is no question but that this record shows a great
many physicians, and others, to have "accepted" marijuana as having a medical
use in the treatment of cancer patients' emesis.

True, all physicians have not

"accepted" it. But to require universal, 100% acceptance would be unreasonable.
Acceptance by "a respectable minority" of physicians is all that can reasonably
be required.

The record here establishes conclusively that at least •a respec-

table minority• of physicians has "accepted" marijuana as having a "medical use
in treatment in the United States." That others may not makes no difference.
The administrative law judge recommended this same approach for determining
whether a drug has an "accepted medical use in treatment• in The Matter Of MOMA
Scheduling, Docket No. 84-48. The Adminstrator, in his first final rule in that
proceeding, issued on October 8, 19868, declined to adopt this approach.
8

Sl Fed. Reg. 36SS2 (1986).
- 29 -

He

ruled, instead, that DEA's decision on whether or not a drug or other substance
had an accepted medical use in treatment in the United States would be determined simply by ascertaining whether or not "the drug or other substance is
lawfully marketed in the United States pursuant to the Federal Food, Drug and
Cosmetic Act of 1938 • • • • •9
The United States Court of Appeals for the First Circuit held that the
Administrator erred in so ruling.10 That court vacated the final order of
October 8, 1986 and remanded the matter of MOMA's scheduling for further consideration.

The court directed that, on remand, the Administrator would not be

permitted to treat the absence of interstate marketing approval by FDA as conclusive evidence on the question of accepted medical use under the Act.
In his third final rulell on the matter of the scheduling of MOMA the
Administrator made a series of findings of fact as to MOMA, the drug there under
consideration, with respect to the evidence in that record.

On those findings

he based his last final rule in the case.12
9

Ibid., at 36558.

10 Grinspoon v. Drug Enforcement Administration, 828 F.2d 881 (1st, Cir.,

1987).

11 53 Fed. Reg. 5156 (1988). A second final rule had been issued on January
20, 1988. It merely removed MOMA from Schedule I pursuant to the mandate of
the Court of Appeals which had voided the first final rule placing it there.
Subsequently the third final rule was issued, without any further hearings,
again placing MOMA in Schedule I. There was no further appeal,
12

In neither the first nor the third final rule in the MOMA case does the
Administrator take any cognizance of the statements to the Congressional
con111ittee by predecessor Agency officials that the determination as to
"accepted medical use in treatment" is to be made by the medical community
and not by any part of the federal government. See page 27, above. It is
curious that the Administrator makes no effort whatever to show how the BNDO
representatives were mistaken or to explain why he now has abandoned their
interpretation. They wrote that language into the original bill.
- 30 -

That third final rule dealing with MOMA is dealing with a synthetic, "simple", "single-action" drug.

What might be appropriate criteria for a "simple"

drug like MOMA may not be appropriate for a "complex" substance with a number
of active components. The criteria applied to MOMA, a synthetic drug, are not
appropriate for application to marijuana, which is a natural plant substance.
The First Circuit Court of Appeals in the MOMA case told the AdminiStrator
that he should not treat the absence of FDA interstate marketing approval as
conclusive evidence of lack of currently accepted medical use.

The court did

not forbid the Administrator from considering the absence of FDA approval as a
factor when determining the existence of accepted medical use.

Yet on remand,

in his third final order, the Administrator adopted by reference 18 of the numbered findings he had made in the first final order.

Each of these findings had

to do with requirements imposed by FDA for approval of a new drug applic'ation
(NOA) or of an investigational new drug exemption (IND).

These requirements

deal with data resulting from controlled studies and scientifically conducted
investigations and tests.
Among those findings incorporated into the third final MOMA order from the
first, and relied on by the Administrator, was the determination and recommendation of the FDA that the drug there in question was not "accepted".

In relying

on the FDA's action the Administrator apparently overlooked the fact that the
FDA clearly stated that it was interpreting "accepted medical use" in the Act as
being equivalent to receiving FDA approval for lawful marketing under the FDCA.
Thus the Administrator accepted as a basis for his MOMA third final rule the FDA
recommendation which was based upon a statutory interpretation which the Court.

- 31 -

of Appeals had condemned.
The Administrator in that third final rule made a series of further findings.
Again, the central concern in these findings was the content of test results and
the sufficiency or adequacy of studies and scientific reports.

A careful reading

of the criteria considered in the MOMA third final order reveals that the
Administrator was really considering the question:
for medical use?; rather than the question:

Should the drug be accepted

Has the drug been accepted for

medical use? By considering little else but scientific test results and reports
the Administrator was making a determination as to whether or not, in his opinion,
MOMA ought to be accepted for medical use in treatment.
The Agency's arguments in the present case are to the same effect.
word, they address the wrong question.

It is not for this Agency to

In a

tel~

doctors whether they should or should not accept a drug or substance for medical
use.

The statute directs the Administrator merely to ascertain whether, in

fact, doctors have done so.
The MOMA third final order mistakenly looks to FDA criteria for guidance in
choosing criteria for DEA to apply.

Under the Food, Drug and Cosmetic Act the

FDA is deciding - properly, under that statute - whether a new drug should be
introduced into interstate commerce.

Thus it is appropriate for the FDA to rely

heavily on test results and scientific inquiry to ascertain whether a drug is
effective and whether it is safe. The FDA must look at a drug and pass judgement on its intrinsic qualities. The DEA, on the other hand, is charged by 21
U.S.C. § 812(b)(l)(B) and (2)(B) with ascertaining what it is that other people
have done with respect to a drug or substance:
"Should they accept it?"

- 32 -

"Have they accepted it?;" not

In the MOMA third final order DEA is actually making the decision that
doctors have to make, rather than trying to ascertain the decision which doctors
have made.

Consciously or not, the Agency is undertaking to tell doctors what

they should or should not accept.

In so doing the Agency is acting beyond the

authority granted in the Act.

'1'

It is entirely proper for the Administrator to consider the pharmacO'logy of
a drug and scientific test results in connection with determining abuse potential.
But abuse potential is not in issue in this marijuana proceeding.
There is another reason why DEA should not be guided by FDA criteria in
ascertaining whether or not marijuana has an accepted medical use in treatment.
These criteria are applied by FDA pursuant to Section 505 of the Federal Food,
Drug and Cosmetic Act (FOCA), as amended.13 When the FDA is making an inquiry
pursuant to that legislation it is looking at a synthetically
The marijuana plant is anything but a new drug.

formed~

drug.

Uncontroverted evidence in this

record indicates that marijuana was being used therapeutically by mankind 2000
years before the Birth of Christ.14
Uncontroverted evidence further establishes that in this country today "new
drugs" are developed by pharmaceutical companies possessing resources sufficient
to bear the enormous expense of testing a new drug, obtaining FDA approval of
its efficacy and safety, and marketing it successfully.

No company undertakes

the investment required unless it has a patent on the drug, so it can recoup its
development costs and make a profit.

At oral argument Government counsel con-

ceded that "the FDA system is constructed for pharmaceutical companies.
13

21

u.s.c.

§ 355.

14 Alice M. O'Leary, direct, par. 9.

- 33 -

I won't

deny that.• 15
Since the substance being considered in this case is a natural plant rather
than a synthetic new drug, it is unreasonable to make FDA-type criteria determinative of the issue in this case, particularly so when such criteria are irrelevant to the question posed by the Act: Does the substance have an accepted
medical use in treatment?
Finally, the Agency in this proceeding relies in part on the FDA's
recommendation that the Administrator retafo marijuana in Schedule I. But, as
in the MOMA case, that reco111nendat1on is based upon FDA's equating •accepted
medical use" under the Act with being approved for marketing by FDA under the
Food, Drug and Cosmetic Act, the interpretation condemned by the First Circuit
in the MOMA case. See Attachment A, p.24, to exhibit G-1 and exhibit G-2.
The overwhelming preponderance of the evidence in this record establishes
that marijuana has a currently accepted medical use in treatment in the United
States for nausea and vomiting resulting from chemotheraphy treatments in some
cancer patients. To conclude otherwise, on this record, would be unreasonable,
arbitrary and capricious.

15

Tr. XV-37.
- 34 -

VI.
ACCEPTED MEDICAL USE IN TREATMENT
- GLAUCOMA
Findings of Fact
The preponderance of the evidence establishes the following facts with
respect to the accepted medical use of marijuana in the treatment of glaucoma.
1. Glaucoma is a disease of the eye characterized by the excessive
accumulation of fluid causing increased intraocular pressure, distorted vision
and, ultimately, blindness.

In its early stages this pressure can sometimes be

relieved by the administration of drugs.

When such medical treatment fails

adequately to reduce the intraocular pressure (IOP), surgery is generally resorted
to.

Although useful in many cases, there is a high incidence of failure with

some types of surgery. Further, serious complications can occur as a result of
invasive surgery.

Newer, non-invasive procedures such as laser trabeculoplasty

are thought by some to offer much greater efficacy with fewer complications.
Unless the IOP is relieved and brought to a satisfactory level by one means or
another, the patient will go blind.
2. Two highly qualified and experienced ophthalmologists in the United
States have accepted marijuana as having a medical use in treatment for
glaucoma. They are John

c.

Merritt, M.D. and Richard D. North, M.D.

Each of

them is both a clinician, treating patients, and a researcher. Dr. Merritt is
also a professor of ophthalmology.

Dr. North has served as a medical officer in

ophthalmology for the Department of Health, Education and Welfare and has worked
with the Public Health Service and FDA.
- 35 -

3. Dr. Merritt's experience with glaucoma patients using marijuana
medicinally includes one Robert Randall and, insofar as the evidence here
establishes per petitioners' briefs, an unspecified number of other patients,
something in excess of 40.
4. Dr. North has treated only one glaucoma patient using marijuana
medicinally - the same Robert Randall mentioned immediately above.

Dr. North

had monitored Mr. Randall's medicinal use of marijuana for nine years as of May
1987.
5. Dr. Merritt has accepted marijuana as having an important place in
the treatment of "End Stage" glaucoma.

"End Stage" glaucoma, essentially,

defines a patient who has already lost substantial amounts of vision; available
glaucoma control drugs are no longer able adequately to reduce the intraocular
pressure (IOP) to prevent further, progressive sight loss; the patient, lacking
additional IOP reductions, will go blind.
6. Robert
ophthalmologist.

s.

Hepler, M.D., is a highly qualified and experienced

He has done research with respect to the effect of smoking

marijuana on glaucoma.

In December 1975 he prescribed marijuana for the same

Robert Randall mentioned above as a research subject. Dr. Hepler found that
large dosages of smoked marijuana effectively reduced Robert Randall's IOP into
the safe range over an entire test day.

He concluded that the only known

alternative to preserve Randall's sight which would avoid the significant risks
of surgery is to include marijuana as part of Randall's prescribed medical
regimen.

He further concluded in 1977 that, if marijuana could have been

legally prescribed, he would have prescribed it for Randall as part of Randall's
regular glaucoma maintenance program had he been Randall's personal physician.

- 36 -

Nonetheless, in 1987 Dr. Hepler was of the opinion that marijuana did not have a
currently accepted medical use in the United States for the treatment of
glaucoma.
7.

Four glaucoma patients testified in these proceedings.

Each has

found marijuana to be of help in controlling IOP.
8.

In 1984 the treatment of glaucoma with Cannabis was the sub.feet of

an Ophthalmology Grand Rounds at the University of California, San Francisco. A
questionnaire was distributed which queried the ophthalmologists on cannabis
therapy for glaucoma patients refractory to standard treatment.
have glaucoma patients who have asked about marijuana.

Many of them

Most of the responding

ophthalmologists believed that THC capsules or smoked marijuana need to be available for patients who have not benefitted significantly from standard treatment.
9,

In about 1978 an unspecified number of persons in the public health

service sector in New Mexico, including some physicians, accepted marijuana as
having medical use in treating glaucoma.
10. A majority of an unspecified number of ophthalmologists known to
Arthur Kaufman, M.D., who was formerly in general practice but now is employed
as a medical program administrator, accept marijuana as having medical use in
treatment of glaucoma.
11.

In addition to the physicians identified and referred to in the

findings above, the testimony of patients in this record establishes that no
more than three or four other physicians consider marijuana to be medically
useful in the treatment of glaucoma in the United States.

One of those

physicians actually wrote a prescription for marijuana for a patient, which, of
course, she was unable to have filled.

-~

-

12. There are test results showing that smoking marijuana has reduced
the IOP in some glaucoma patients. There is continuing research underway in the
United States as to the therapeutic effect of marijuana on glaucoma.

Discussion
Petitioners' briefs fail to show that the preponderance of the evidence in
the record with respect to marijuana and glaucoma establishes that a respectable
minority of physicians accepts marijuana as being useful in the treatment of
glaucoma in the United States.
This conclusion is not to be taken in any way as criticism of the opinions
of the ophthalmologists who testified that they accept marijuana for this purpose.

The failure lies with petitioners.

In their briefs they do not point out

hard, specific evidence in this record sufficient to establish that a respectable
minority of physicians has accepted their position.
There is a great volume of evidence here, and much discussion in the briefs,
about the protracted case of Robert Randall. But when all is said and done, his
experience presents but one case. The record contains sworn testimony of three
ophthalmologists who have treated Mr. Randall.

One of them tells us of a

relatively small number of other glaucoma patients whom he has treated with
marijuana and whom he knows to have responded favorably.

Another of these three

doctors has successfully treated only Randall with marijuana. The third testifies, despite his successful experience in treating Randall, that marijuana
does not have an accepted use in such treatment.
In addition to Robert Randall, Petitioners point to the testimony of three
other glaucoma patients. Their case histories are impressive, but they contribute
- 38 -

little to the carrying of Petitioner's burden of showing that marijuana is accepted
for medical treatment of glaucoma by a respectable minority of physicians.

See

pages 26-29, above.
Petitioners have placed in evidence copies of a number of newspaper clippings
reporting statements by persons claiming that marijuana has helped their glaucoma.
The admi ni strati ve law judge is unable to give significant weight to this evidence.
Had these persons tesified so as to have been subject to cross-examination, a
different situation would be presented.

But these newspaper reports of

extra-judicial statements, neither tested by informed inquiry nor supported by a
doctor's opinion, are not entitled to much weight.

They are of little, if any,

materiality.
Beyond the evidence referred to above there is little other "hard"
evidence, pointed out by petitioners, of physicans accepting marijuana for treatment of glaucoma.

Such evidence as that concerning a survey of a group of San

Francisco ophthalmologists is ambiguous, at best.

The relevant document establishes

merely that most of the doctors on the grand rounds, who responded to an inquiry,
believed that the THC capsules

~marijuana

ought to be available.

In sum, the evidence here tending to show that marijuana is accepted for
treatment of glaucoma falls far, far short of the quantum of evidence tending to
show that marijuana is accepted for treatment of emesis in cancer patients.

The

preponderance of the evidence here, identified by petitioners in their briefs,
does n'ot establish that a respectable minority of physicians has accepted
marijuana for glaucoma treatment.

- 39 -

VII.
ACCEPTED MEDICAL USE IN TREATMENT
- MULTIPLE SCLEROSIS, SPASTICITY
AND HYPERPARATHYROIDISM
Findings Of Fact
The preponderance of the evidence clearly establishes the following facts
with respect to marijuana's use in connection with multiple sclerosis,
spasticity and hyperparathyroidism.
1. Multiple sclerosis is the major cause of neurological disability
among young and middle-aged adults in the United States today.
disease.

It is a life-long

It can be extremely debilitating to some of its victims but it does

not shorten the life span of most of them.

Its cause is yet to be determined.

It attacks the myelin sheath, the coating or insulation surrounding the
message-carrying nerve fibers in the brain and spinal cord.

Once the myelin

sheath is destroyed, it is replaced by plaques of hardened tissue known as
sclerosis. During the initial stages of the disease nerve impulses are transmitted with only minor interruptions. As the disease progresses, the plaques
may completely obstruct the impulses along certain nerve systems.

These obstruc-

tions produce malfunctions. The effects are sporadic in most individuals and
the effects often occur episodically, triggered either by malfunction of the
nerve impulses or by external factors.
2. Over time many patients develop spasticity, the involuntary and
abnormal contraction of muscle or muscle fibers.

(Spasticity can also result

from serious injuries to the spinal cord, not related to multiple sclerosis.)
3. The symptoms of multiple sclerosis vary according to the area of
- 40 -

the nervous system which is affected and according to the severity of the disease.
The symptoms can include one or more of the following:

weakness. tingling,

numbness, impaired sensation, lack of coordination, disturbances in equilibrium,
double vision, loss of vision, involuntary rapid movement of the eyes (nystagmus),
slurred speech, tremors, stiffness, spasticity, weakness of limbs, sexual dysfunction, paralysis, and impaired bladder and bowel functions.
4.

Each person afflicted by multiple sclerosis is affected differently.

In some persons, the symptoms of the disease are barely detectable, even over
long periods of time.

In these cases, the persons can live their lives as if

they did not suffer from the disease.

In others, more of the symptoms are present

and acute, thereby limiting their physical capabilities. Moreover, others may
experience sporadic, but acute, symptoms.
5.
sclerosis.

At this time, there is no known prevention or cure for multiple
Instead, there are only treatments for the symptoms of the disease.

There are very few drugs specifically designed to treat spasticity.
often cause very serious side effects,

These drugs

At the present time two drugs are

approved by FDA as "safe" and "effective" for the specific indication of
spasticity.
6.

These drugs are Dantrium and Lioresal baclofen.
Unfortunately, neither Dantrium nor Lioresal is a very effective

spasm control drug.

Their marginal medical utility, high toxicity and potential

for serious adverse effects make these drugs difficult to use in spasticity
therapy.
7.

As a result, many physicians routinely prescribe tranquilizers,

muscle relaxants, mood elevators and sedatives such as Valium to patients
experiencing spasticity. While these drugs do not directly reduce spasticity

- 41 -

they may weaken the patient's muscle tone. thus making the spasms less noticeable,

Alternatively, they may induce sleep or so tranquilize the patient that

normal mental and physical functions are impossible.
8. A healthy, athletic young woman named Valerie Cover was stricken
with multiple sclerosis while in her early twenties.

She consulted several

medical specialists and followed all the customary regimens and prescribed
methods for coping with this debilitating disease over a period of several years.
None of these proved availing.

Two years after first experiencing the symptoms

of multiple sclerosis her active, productive life - as an athlete, Navy officer's
wife and mother - was effectively over. The Social Security Administration
declared her totally disabled.

To move about her home she had to sit on a skate-

board and push herself around.

She spent most of her time in bed or sitting in

a wheelchair.
9. An occasional marijuana smoker in her teens, before her marriage,
she had not smoked it for five years as of February 1986. Then a neighbor
suggested that marijuana just might help Mrs. Cover's multiple sclerosis, having
read that it had helped cancer patient's control their emesis.

Mrs. Cover

acceded to the suggestion.
10. Just before smoking the marijuana cigarette produced by her neighbor,
Mrs. Cover had been throwing up and suffering from spasms.

Within five minutes

of smoking part of the marijuana cigarette she stopped vomiting, no longer felt
nauseous and noticed that the intensity of her spasms was significantly reduced.
She stood up unaided.
11. Mrs. Cover began smoking marijuana whenever she felt nauseated.
When she did so it controlled her vomiting, stopped the nausea and increased her

- 42 -

appetite.

It helped ease and control her spasticity.

Her limbs were much easier

to control. After three months of smoking marijuana she could walk unassisted,
had regained all of her lost weight, her seizures became almost nonexistent.
She could again care for her children.

She could drive an automobile again.

She regained the ability to lead a normal life.

"·

12. Concerned that her use of this illegal substance might jeOflardize
the career of her Navy officer husband, Mrs. Cover stopped smoking marijuana
several times.

Each time she did so, after about a month, she had retrogressed

to the point that her multiple sclerosis again had her confined to bed and wheelchair or skateboard.

As of the Spring of lg87 Mrs. Cover had resumed smoking

marijuana regularly on an "as needed" basis.
are under excellent control.

Her multiple sclerosis symptoms

She has obtained a full-time job. She still needs

a wheelchair on rare occasions, but general.ly has full use of her limbs and can
walk around with relative ease.
13. Mrs. Cover's doctor has accepted the effectiveness of marijuana in
her case.

He questioned her closely about her use of it, telling her that it is

the most effective drug known in reducing vomiting. Mrs. Cover and her doctor
are now in the process of filing an Investigational New Drug (IND) application
with FDA so that she can legally obtain the marijuana she needs to lead a reasonably normal life.
14. Martha Hirsch is a young woman in her mid-thirties. She first
exhibited symptoms of multiple sclerosis at age 19 and it was diagnosed at that
time.

Her condition has grown progressively worse.

She has been under the care

of physicians and hospitalized for treatment. Many drugs have been prescribed
for her by her doctors.

At one point in 1983 she listed the drugs that had been

- 43 -

prescribed for her. There were 17 on the list.

None of them has given her the

relief from her multiple sclerosis symptoms that marijuana has.
15. During the early stages in the development of her illness Ms.
Hirsch found that smoking marijuana improved the quality of her life. keeping
her spasms under control.

Her balance improved.

She seldom needed to use her

cane for support. Her condition lately has deteriorated. As of May 1987 she
was experiencing severe. painful spasms.
bladder.

She had an indwelling catheter in her

She had lost her locomotive abilities and was wheelchair bound. She

could seldom find marijuana on the illegal market and, when she did. she often
could not afford to purchase it. When she did obtain some. however. and smoked
it. her entire body seemed to relax. her spasms decreased or disappeared, she
slept better and her dizzy spells vanished. The relaxation of her leg muscles
after smoking marijuana has been confirmed by her personal care attendant's
examination of them.
16. The personal care attendant has told Ms. Hirsch that she. the
attendant. treats a number of patients who smoke marijuana for relief of multiple sclerosis symptoms.

In about 1980 another patient told Ms. Hirsch that he

knew many patients who smoke marijuana to relieve their spasms. Through him she
met other patients and found that marijuana was commonly used by many multiple
sclerosis patients. Most of these persons had told their doctors about their
doing so.

None of those doctors advised against the practice and some encouraged

it.,:

17. Among the drugs prescribed by doctors for Ms. Hirsch was ACTH.
This failed to give her any therapeutic benefit or to control her spasticity. It
did produce a number of adverse effects. including severe nausea and vomiting
which. in turn. were partly controlled by rectally administered anti-emetic
- 44 -

drugs.
18. Another drug prescribed for her was Lioresal, intended to reduce
her spasms.

It was not very effective in so doing.

to have hallucinations.

But it did cause Ms. Hirsch

On two occasions, while using this drug, Ms. Hirsch

"saw" a large fire in her bedroom and called for help.
stopped using that drug.

There was no firet''

She

Ms. Hirsch has experienced no adverse reactions'' with

marijuana.
19. Ms. Hirsch's doctor has accepted marijuana as beneficial for her.
He agreed to write her a prescription for it, if that would help her obtain it.
She has asked him if he would file an IND application with FDA for her.
replied that the paperwork was "overwhelming".

He

He indicated wi 11 i ngness to help

in this undertaking after Ms. Hirsch found someone else willing to put the paperwork together.
20.

When Greg Paufler was in his early twenties, employed by Prudential

Insurance Company, he began to experience the first symptoms of multiple sclerosis.
His condition worsened as the disease intensified.
He lost the ability to walk, to stand.

He had to be hospitalized.

Diagnosed as having multiple sclerosis,

a doctor prescribed ACTH for him, an intensive form of steroid therapy.
all control over his limbs and experienced severe, painful spasms.

He lost

His arms and

legs became numb.
21.

ACTH had no beneficial effects.

The doctor continued to prescribe

it over many months.

ACTH made Paufler ravenously hungry and he began gaining a

great deal of weight.

ACTH caused fluid retention and Paufler became bloated,

rapidly gaining weight.

His doctor thought Paufler should continue this steroid

therapy, even though it caused the adverse effects mentioned plus the possiblity
of sudden heart attack or death due to respiratory failure.
- 45 -

Increased dosages

of this FDA-approved drug caused fluid to press against Paufler's lungs making
it difficult for him to breathe and causing his legs and feet to become swollen.
The steroid therapy caused severe, intense depression marked by abrupt mood
shifts.
control.

Throughout, the spasms continued and Paufler's limbs remained out of
The doctor insisted that ACTH was the only therapy likely to be of any

help with the multiple sclerosis, despite its adverse effects. Another, oral,
steroid was eventually substituted.
22. One day Paufler became semi-catatonic while sitting in his living
room at home. He was rushed to the hospital emergency room.

He nearly died.

Lab reports indicated, among other things, a nearly total lack of potassium in
his body,

He was given massive injections of potassium in the emergency room

and placed on an oral supplement.
23.

Paufler resolved to take no more steroids.

From time to time, prior to this point, Paufler had smoked

marijuana socially with visiting friends, seek some relief from his misery in a
temporary "high".

He now began smoking marijuana more often. After some weeks

he found that he could stand and then walk a bit. His doctor dismissed the idea
that marijuana could be helpful with multiple sclerosis, and Paufler, himself,
was skeptical at first.
24.

He began discontinuing it for a while, then resuming,

Paufler found that when he did not smoke marijuana his condition

worsened, he suffered more intense spasms more frequently.

When he smoked

marijuana, his condition would stabilize and then improve; spasms were more
controlled and less severe; he felt better; he regained control over his limbs
and could walk totally unaided.

His vision, often blurred and unfocused,

improved.

Eventually he began smoking marijuana on a daily basis. He ventured

outdoors.

He was soon walking half a block. His eyesight returned to normal.

- 46 -

His central field blindness cleared up.
again.

He could focus well enough to read

One evening he went out with his children and found he could kick a

soccer ball again.
25.

Paufler has smoked marijuana regularly since 1980.

time his multiple sclerosis has been well controlled.
astonished at Paufler's recovery.
foot with his eyes closed.
seems miraculous.

Paufler can now run.

Since that

His doctor has been
He can stand Oll'!one

The contrast with his condition. several years ago,

Smoking marijuana when Paufl er feels an attack coming on

shortens the attack.

Paufler's doctor has looked Paufler in the eye and told

him to keep doing whatever it is he's doing because it works.

Paufler and his

doctor are exploring the possbility of obtaining a compassionate IND to provide
legal access to marijuana for Paufler.
26.

Paufler learned in about 1980 of the success of one Sam Diana, a

multiple sclerosis patient, in asserting the defense of "medical necessity" in
court when charged with using or possessing marijuana.

He learned that doctors,

researchers and other multiple sclerosis patients had supported Diana's position
in the court proceeding.
27.
thyroidism.
the body.

Irwin Rosenfeld has been diagnosed as having Pseudo Pseudo HypoparaThis unco11111on disease causes bone spurs to appear and grow all over

Over the patient's lifetime hundreds of these spurs can grow, any one

of which can become malignant at any time.

The resulting cancer would spread

quickly and the patient would die.
28.
mous pain.

Even without development of a malignancy. the disease causes enorThe spurs press upon adjacent body tissue, nerves and organs.

In

Rosenfeld's case, he could neither sit still nor lie down. nor could he walk,

- 47 -

without experiencing pain. Working in his furniture store in Portsmouth,
Virginia, Mr. Rosenfeld was on his feet moving furniture all day long. The
lifting and walking caused serious problems as muscles and tissues rubbed over
the spurs of bone.

He tore muscles and hemorrhaged almost daily.

29. Rosenfeld's symptoms first appeared about the age of ten.
drugs were prescribed for him for pain relief.
narcotics.

Various

He was taking extremely powerful

By the age of 19 his therapy included 300 mg. of Sopor (a powerful

sleeping agent) and very high doses of Dilaudid.

He was found to be allergic to

barbiturates. Taking massive doses of pain control drugs, as prescribed, made
it very difficult for Rosenfeld to function normally.

If he took enough of them

to control the pain, he could barely concentrate on his schoolwork.

By the time

he reached his early twenties Rosenfeld's monthly drug intake was between 120 to
140 Dilaudid tablets, 30 or more Sopor sleeping pills and dozens of muscle
relaxants.
30. At college in Florida Rosenfeld was introduced to marijuana by
classmates.

He experimented with it recreationally.

"high" or "buzz" or "floating sensation" from it.
while playing chess with a friend.

He never experienced a

One day he smoked marijuana

It had been very difficult for him to sit

for more than five or ten minutes at a time because of tumors in the backs of
his legs. Suddenly he realized that, absorbed in his chess game, and smoking
martjuana, he had remained sitting for over an hour - with no pain.

He

experimented further and found that his pain was reduced whenever he smoked
marijuana.
31. Rosenfeld told his doctor of his discovery. The doctor opined
that it was possible that the marijuana was relieving the pain.

- 48 -

Something

certainly was - there was a drastic decrease in Rosenfeld's need for such drugs
as Dilaudid and Demerol and for sleeping pills.

The quality of pain relief

which followed his smoking of marijuana was superior to any he had experienced
before.

As his dosages of powerful conventional drugs decreased, Rosenfeld

became less withdrawn from the world, more able to interact and function':

So he

has continued to the present time.
32. After some time Rosenfeld's doctor accepted the fact that the
marijuana was therapeutically helpful to Rosenfeld and submitted an IND application to FDA to obtain supplies of it legally for Rosenfeld.
insisted, however, that he not be publicly identified.
IND application was granted.
NIDA.

The doctor has

After some effort the

Rosenfeld is receiving supplies of marijuana from

Rosenfeld testified before a committee of the Virginia legislature in

about 1979 in support of legislation to make marijuana available for therapeutic
purposes in that State.
33.

In 1969, at age 19, David Branstetter dove into the shallow end of

a swimming pool and broke his neck.

He became a quadraplegic, losing control

over the movement of his arms and legs.
he returned home.

After being hospitalized for 18 months

Valium was prescribed for him to reduce the severe spasms

associated with his condition.

He became mildly addicted to Valium.

Although

it helped mask his spasms, it made Branstetter more withdrawn and less able to
take care of .himself.
long-term addiction.

He stopped taking Valium for fear of the consequences of
His spasms then became uncontrollable, often becoming so

bad they would throw him from his wheelchair.
34.

In about 1973 Branstetter began smoking marijuana recreationally.

He discovered that his severe spasms stopped whenever he smoked marijuana.

- 49 -

Unlike Valium. which only masked his symptoms and caused him to feel drunk and
out of control, marijuana brought his spasmodic condition under control without
impairing his faculties.

When he was smoking marijuana regularly he was more

active. alert and outgoing.
35. Marijuana controlled his spasms so well that Branstetter could go
out with friends and he began to play billiards again.

The longer he smoked

marijuana the more he was able to use his arms and hands.

Marijuana also

improved his bladder control and bowel movements.
36. At times the illegal marijuana Branstetter was smoking became very
expensive and sometimes was unavailable.

During periods when he did not have

marijuana his spasms would return, preventing Branstetter from living a "normal"
life. He would begin to shake uncontrollably, his body would feel tense; and
his muscles would spasm.
37.
marijuana.

In 1979 Branstetter was arrested and convicted of possession of
He was placed on probation for two years.

During that period he

continued smoking marijuana and truthfully reportd this, and the reason for it,
to his probation officer whenever asked about it.

No action was taken against

Branstetter by the court or probation authorities because of his continuing use
of marijuana, except once in the wake of his publicly testifying about it before
the Missouri legislature. Then, although adverse action was threatened by the
judge, nothing was actually done.
38.

In 1981 Branstetter and a friend, a paraplegic, participated in a

research study testing the therapeutic effects of synthetic THC on spasticity.
Placed on the THC Branstetter found that it did help control his spasms but
appeared to became less effective with repeated use.

- 50 -

Also, unlike marijuana,

synthetic THC had a powerful mind-altering effect he found annoying.

When the

study ended the researcher strongly suggested that Branstetter continue smoking
marijuana to control his spasms.
39. None of Branstetter's doctors have told him to stop smoking marijuana while several, directly and indirectly, have encouraged him to continue.
~·

Branstetter knows of almost 20 other patients, paraplegics,

quadraplegic~

and

multiple sclerosis sufferers, who smoke marijuana to control their spasticity.
40.

In 1981 a State of Washington Superior Court judge, sitting with-

out a jury, found Samuel D. Diana not guilty of the charge of unlawful possession of marijuana.

In so doing the judge upheld Diana's·defense of medical

necessity. Diana had been a multiple sclerosis patient since at least 1973. He
testified that smoking marijuana relieved his symptoms of double vision, tremors,
unsteady walk, impaired hearing, tendency to vomit in the mornin9s and stiffness
in the joints of his hands and legs.
41. Among the witnesses was a physician who had examined defendant
Diana before and after he had used marijuana. This doctor tesified that
marijuana had been effective therapeutically for Diana, that other medication
had proven ineffective for Diana and that, while marijuana may have some detrimental effects, Diana would receive more benefit than harm from smoking.it. The
doctor was. not aware of any other drug that would be as effective as marijuana
for Mr. Diana.

Other witnesses included three persons afflicted with multiple

sclerosis who tesified in detail as to marijuana's beneficial effect on their
illness.
42.

In acquitting defendant Diana of unlawful possession of marijuana

the trial judge found that the three requirements for the defense of medical
necessity had been established, namely: defendant's reasonable belief that his
- 51 -

use of marijuana was· necessary to minimize the effects of multiple sclerosis; .
the benefits derived from its use are greater than the harm sought to be prevented by the controlled substances law; and no drug is as effective as marijuana
in minimizing the effects of the disease in the defendant.
43.

Denis Petro, M.D., is a neurologist of broad experience, ranging

from active practice in neurology to teaching the subject in medical school and
employment by FDA as a medical officer reviewing IND's and NDA's.

He has also

been employed by pharmaceutical companies and has served as a consultant to the
State of New York.

He is well acquainted with the case histories of three

patients who have successfully utilized marijuana to control severe spasticity
when other, FDA-approved drugs failed to do so.

Dr. Petro knows of other cases

of patients who, he has determined, have effectively used marijuana to control
their spasticity.

He has heard reports of additional· patients with multiple

sclerosis, paraplegia and quadriplagia doing the same-. There are reports published in the literature known to Dr. Petro, over the period at least 1970 1986, of clinical tests demonstrating that marijuana and THC are effective in
controlling or reducing spasticity in patients.
44.

Large numbers of paraplegic and quadriplegic P.atients, particularly

in Veterans Hospitals, routinely smoke marijuana to reduce spasticity.

While

this mode of treatment is illegal, it is generally tolerated, if not openly
encouraged, by physicians in charge of such wards who accept this practice as
being of benefit to their patients.

There are many spinal cord injury patients

in Veterans Hospitals.
45.

Dr. Petro sought FDA approval to conduct research with spasticity

patients using marijuana.

FDA refused but, for reasons unknown to him, allowed

- 52 -

him to make a study using synthetic THC.

He and colleagues made such a study.

They concluded that synthetic THC effected a significant reduction in spasticity
among multiple sclerosis patients. but study participants who had also smoked
marijuana reported consistently that marijuana was more effective.
46.

Dr. Petro accepts marijuana as having a medical use in the-,

treatment of spasticity in the United States.

If it were legally availaMe and

he was engaged in an active medical practice again, he would not hesitate to
prescribe marijuana, when appropriate. to patients afflicted with uncontrollable
spasticity.
47._ Dr. Petro presented a paper to a meeting of the American Academy
of Neurology.

The paper was accepted for presentation.

After he presented it

Dr. Petro found that many of the neurologists present at this most prestigious
meeting were in agreement with his acceptance of marijuana as having a medical
use in the treatment of spasticity.
48.

Dr. Andrew Weil, a general medicine practitioner in Tucson.

Arizona, who also teaches at the University of Arizona College of Medicine.
accepts marijuana as having a medical use in the treatment of spasticity.

In

multiple sclerosis patients the muscles become tense and rigid because their_
nerve supply is interrupted. Marijuana relieves this spasticity in many
patients. he has found.

He would prescribe it to selected patients if it were

legally available.
49.

Dr. Lester B. Collins, III, a neurologist, then treating about 20

multiple sclerosis patients a year, seeing two or three new ones each year,
stated in 1983 that he had no doubt that marijuana worked symptomatically for
some multiple sclerosis patients.

He said that it does not alter the course of

- 53 -

the disease but it does relieve the symptoms of spasticity.
50. Dr. John P. Morgan, board certified in internal medicine, Professor
of Medicine and Director of Pharmacology at CCNY Medical School in New York and
Associate Professor of Medicine and Pharmacology at Mt. Sinai School of .Medicine,
accepts marijuana as having medical use in treatment in the United .States.

If

he were practicing medicine and marijuana were legally available he would prescribe it when indicated to patients with legitimate medical needs .
'

Discussion
Based upon the rationale set out in pages 26 to 34, above, the administrative
law judge concludes that, within the ·meaning of the Act, 21

u.s.c. § 812(b)(2)(B),

marijuana "has a currently accepted medical use in treatment in the United States"
for spasticity resulting from multiple sclerosis and other causes.

It would be

unreasonable, arbitrary and capricious to find otherwise. The facts set out
above, uncontroverted by the Agency, establish beyond question that some doctors
in the United States accept marijuana as helpful ·in such treatment for some
patients . The record here shows that they constitute a significant minority of
physicians. Nothing more can reasonably be required. That some doctors would
have more studies and test results in hand before accepting marijuana's usefulness here is irrelevant.
The same is true with respect to the hyperparathyroidism from which Irvin
Rosenfeld suffers.

His disease is so rare, and so few physicians appear to be

familiar with it, that

accepta~ce

by one doctor of marijuana as being useful in

treating it ought .to satisfy the requirement for a significant minority. The
Agency points to no evidence of record tending to establish that marijuana is
- 54 -

not accepted by doctors in connection with this most unusual ailment.

Refusal

to acknowledge acceptance by a significant minority, in light of the case history detailed in this record, would be unreasonable, arbitrary and capricious.

- 55 -

VIII.
ACCEPTED SAFETY FOR USE UNDER MEDICAL SUPERVISION
With respect to whether or not there is •a lack of accepted safety for use
of [marijuana] under medical supervision", the record shows the following facts
to be uncontroverted.

Findings of Fact
1. Richard J . Gralla,

M ~ O.,

an oncologist and Professor of Medicine

who was an Agency witness, accepts that in treating cancer patients oncologists
can use the cannabinoids with safety despite their side effects.
2. Andrew T. Weil, M.D., who now practices medicine in Tucson,
Arizona and is on the faculity of the College of Medicine, University of
Arizona, was a member of the first team of researchers to perform a Federal
Government authorized .study into the effects of marijuana on human subjects.
This team made its study in 1968. These researchers determined that marijuana
could. be safely used under medical supervision.

In the 20 years since then Dr.

Weil has seen no .information that would cause him to reconsider that conclusion .
There is no question in his mind but that marijuana is safe for .use under
appropriate medical supervision.
3. The most obvious concern when dealing with drug safety is the
possibility of lethal effects.
4.

Can the drug cause death?

Nearly all medicines have toxic, potentially lethal effects . But

marijuana is not such a substance. There is no record in the extensive medical
literature describing a proven, documented cannabis-induced fatality •

... 56 ...

5. This is a remarkable statement.

First, the record on marijuana

encompasses 5, 000 years of human experience . Second, marijuana is now used
daily by enormous

of people throughout the world.

num~ers

Estimates suggest

that from twenty million to fifty million Americans routinely, albeit il_
legally,
smoke marijuana without the benefit of direct medical supervision.

Yet , despite

this long history of use and the extraordinarily high numbers of social smokers,
there are simply no credible medical reports to suggest that consuming marijuana
has caused a single death.
6. By contrast aspirin, a commonly used, over-the-counter medicine,
causes hundreds of deaths each year.
7.
LD-50.

Drugs used in medicine are routinely given what is called an

The LD-50 rating indicates at what dosage fifty percent of test animals

receiving a drug will die as a result of drug induced toxicity.

A number of

researchers have attempted to determine marijuana's LD- 50 rating in test animals,
without success.

Simply stated, researchers have been unable to give animals

enough marijuana to induce death.
8.

At

presen~

1 :20,000 or 1 :40,000.

it is estimated that

marijua~a's

LD-50 is around ·

In. layman terms this means that in order to induce

death a marijuana smoker would have to consume 20,000 to 40,000 times as much
marijuana as is contained in one marijuana cigarette.
cigarettes weigh approximately .9 grams.

NIDA~supplied

marijuana

A smoker would theoretically have to

consume nearly 1,500 pounds of marijuana within about fifteen minutes to induce
a lethal response.
9.

In practical terms , marijuana cannot induce a lethal response -as a

result of drug-related toxicity.

- 57 -

10. Another common medical way to determine drug safety is called the
therapeuic ratio.
effective

~ose

This ratio defines the difference between a therapeutically

and a dose which is capable of inducing adverse effects.

11. A commonly used over-the-counter product like aspirin has .a
therapeutic ratio of

aro~nd

1:20. Two aspirins are the recommended dose for

adult patients. Twenty times this dose, forty aspirins, may cause a lethal
reaction in some patients, and will almost certainly cause gross injury to the
digestive system, including extensive

tntern~l

bleeding.

12. The therapeutic ratio for prescribed drugs is co1111lOnly around 1:10
or lower.

Valium, a comnonly used prescriptive drug, may cause very serious

biological damage if patients use ten".times the recommended (therapeutic) dose.
13. There are, of course, prescriptive drugs which have much lower
therapeutic ratios.

Many of the drugs used to treat patients with cancer,

glaucoma and multiple sclerosis are highly toxic. The therapeutic ratio of
s.ome of the drugs used in antineoplastic therapies, for example, are regarded as
extremely toxic poisons with therapeutic ratios that may fall below 1:1.5.
These ' drugs ~lso have very low LD-50 ratios and can result in toxi c, even lethal
reactions, while being. properly employed.
14. By contrast, marijuana's therapeutic ratio, like its LD-50, is
impossible to quantify because it is so high.
15.

In strict medical terms marijuana is far safer than many foods we

commonly consume.
response.

For example, eating ten raw potatoes can result in a toxic

By comparison, it is physically impossible to eat enough marijuana to

induce death.
16. Marijuana, in its natural form, is one of the safest therapeutically

- 58 -

active substances known to man.

By any measure of rational analysis marijuana

can be safely used within a supervised routine of medical care.
17.

Some of the drugs most widely used in chemotherapy treatment of

cancer have adverse effects as follows:
Cisplatin, one of the most powerful chemotherapeuic agents used on humans - may cause deafness ;
may lead to life-threatening kidney difficulties and
kidney failure; adversely affects the body 1 s immune
system, suppressing the patient 1 s ability to fight a
host of common infections.
Nitrogen Mustard, a drug used in therapy for
Hodgkins disease - nauseates; so toxic to the skin
that, if dropped on the skin, this chemical literally
eats it away along with other tissues it contacts; if
patient 1 s intravenous lead slips duri ng treatment and
this drug gets on or under the skin the patient may
suffer serious injury including temporary, and in .
extreme .cases, permanent, loss of use of the arm.
Procarbizine, also used for Hodgkins disease has known psychogenic, i.e., emotional, effects.
Cytoxin, also known as Cyclophosphanide suppresses patient 1 s immune system response; results
in serious bone marrow depletion; studies indicate
this drug may also cause other cancers, including
·
cancers of the bladder .
Adriamycan, has numerous adverse effects; is .
difficult to employ in long term therapies because it
destroys the heart n1.1scle.
While each of these. agents has its particular adverse effects, as indicated
above, they also cause a number of similar, disturbing adverse effects. Most of
these drugs cause hair loss.

Studies increasingly indicate all of these drugs

may cause other forms of cancer.

Death .due to kidney, heart or respiratory

failure i$ a very real possibility with all of these agents and the margin for
error is minimal.
by his cancer.

Similarly, there is a danger of qverdosing a patient weakened

Put simply, there is very great risk associated with the medical
- 59 -

use of these chemicals agents.

Despite these high risks, all of these drugs are

considered "safe" for use under medical supervision and are regularly administered
to patients on doctor's orders in the United States today.
18. There have been occasional instances of panic reaction in patients
who have smoked marijuana. These have occurred in marijuana-naive persons,
usually older persons, who are extremely anxious over the forthcoming chemotherapy
and troubled over the illegality of their having obtained the marijuana.

Such

persons have responded to simple person-to-person communication with a doctor
and have sustained no long term mental or physical damage.

If marijuana could

be legally obtained, and administered in an open, medically-supervised session
rather than surreptitiously, the few instances of such adverse reaction doubtless
would be reduced in number and severity.
19.

Other reported side effects of marijuana have been minimal.

tion often results. Sometimes mild euphoria is experienced.

Seda-

Short periods of

increased pulse rate and of dizziness are occasionally experienced. Marijuana
should not be used by persons anxious or depressed or psychotic or with certain
other health problems.

Physicians could readily screen out such patients if

marijuana were being employed as an agent under medical supervision.
20.

All drugs have "side effects" and all drugs used in medicine for

their therapeutic benefits have unwanted, unintended, sometimes adverse effects.
21.

In medical treatment "safety• is a relative term.

A drug deemed

"safe" for use in treating a life-threatening disease might be "unsafe" if prescribed for a patient with a minor ailment.
relative,

The concept of drug "safety" is

Safety is measured against the consequences a patient would confront

in the absence of therapy. The determination of "safety" is made in terms of

- 60 -

whether a drug's benefits outweigh its potential risks and the risks of permitting the disease to progress.
22.

In the context of glaucoma therapy, it must be kept in mind that

glaucoma, untreated, progressively destroys the optic nerve and results in
eventual blindness.

The danger, then, to patients with glaucoma is an

irretrievable loss of their sight.
23. Glaucoma is not a mortal disease, but a highly specific, selectively
incapacitating condition. Glaucoma assaults and destroys the patient's most
evolved and critical sensory ability, his or her vision.

The vast majority of

patients afflicted with glaucoma are adults over the age of thirty.

The onset

of blindness in middle age or later throws patients into a wholely alien world.
They can no longer do the work they once did.

They are unable to read a

newspaper, drive a car, shop, walk freely and do all the myriad things sighted
people take for granted.

Without lengthy periods of retaining, adaptation and

great effort these individuals often lose their sense of identity and ability to
function.

Those who are young enough or strong-willed enough will regain a

sense of pl ace, hold meaningful jobs, but many aspects of the 1i fe they once
took for granted cannot be recaptured.

Other patients may never fully adjust to

their new, uncertain circumstances.
24.

Blindness is a very grave consequence.

Protecting patients from

blindness is considered so important that, for ophtholmologists generally, it
justifies the use of toxic medicines and uncertain surgical procedures which in
other contexts might be considered "unsafe."

In practice, physicians often

provide gl.aucoma patients with drugs which have many serious adverse effects.
25. There are only a limited number of drugs available for the

- 61 -

treatment of glaucoma.

All of these drugs produce adverse effects.

While

several government witnesses lightly touched on the side effects of these drugs,
none provided a full or detailed description of their known adverse consequences.
26. The adverse physical consequences resulting from the chronic use
of conrnonly employed glaucoma control drugs include a vast range of unintended
complications from mild problems like drug induced fevers, skin rashes, headaches,
anorexia, asthma, pulmonary difficulties, hypertension, hypotension and muscle
cramps to truly serious, even life-threatening complications including the formation of cataracts, stomach and intestinal ulcers, acute respiratory distress,
increases and decreases in heart rate and pulse, disruption of heart function,
chronic and acute renal disease, and bone marrow depletion.
27. Finally, each FDA-approved drug family used in glaucoma therapy is
capable of producing a lethal response, even when properly prescribed and used.
Epinephrine can lead to elevated blood pressure which may result in stroke or
heart attack. Miotic drugs suppress respiration and can cause respiratory
paralysis.

Diuretic drugs so alter basic body chemistry they cause renal stones

and may destroy the patient's kidneys or result in death due to heart failure.
Timolol and related beta-blocking agents, the most recently approved family of
glaucoma control drugs, can trigger severe asthma attacks or cause death due to
sudden cardiac arrhythmias often producing cardiac arrest.
28. Both of the FDA-approved drugs used in treating the symptoms of
multiple sclerosis, Dantrium and Lioresal, while accepted as "safe" can, in
fact, be very dangerous substances.

Dantrium or dantrolene sodium carries a

. boxed warning in the Physician's Desk Reference (PDR) because of its very high
toxicity.

Patients using this drug run a very real risk of developing sympto-

- 62 -

matic hepatitis (fatal and nonfatal}.

The list of sublethal toxic reactions

also underscores just how dangerous Dantrium can be.

The PDR, in part, notes

Dantrium commonly causes weakness, general malaise and fatigue and goes on to
note the drug can also cause constipation, GI bleeding, anorexia, gastri.c irritation, abdominal cramps, speech disturbances, seizure, visual disturbances,, ·
diplopia, tachycardia, erratic blood pressure, mental confusion, clinical ·aepression, renal disturbances, myalgia, feelings of suffocation and death due to
liver failure.
29. The adverse effects associated with Lioresal baclofen are somewhat
less severe, but include possibly lethal consequences, even when the drug is
properly prescribed and taken as directed. The range of sublethal toxic reactions
is similar to those found with Oantrium.
30.

Norman E, Zinberg, M.D., one of Dr. Weil's colleagues in the 1968

study mentioned in finding 2, above, accepts marijuana as being safe for use
under medical supervision.

If it were available by prescription he would use it

for appropriate patients.
31.

Lester Grinspoon, M.D., practicing psychiatrist, researcher and

Associate Professor of Medicine at Harvard Medical School, accepts marijuana as
safe for use under medical supervision. He believes its safety is its greatest,
advantage as a medicine in appropriate cases.
32. Tod H. Mikuriya, M.O., a psychiatrist practicing in Berkley,
California who treats substance abusers as inpatients and outpatients, accepts
marijuana as safe for use under medical supervision.
33, Richard D. North, M.D., who has treated Robert Randall for glaucoma
with marijuana for nine years, accepts marijuana as safe for use by his patient

- 63 -

under medical supervision. Mr. Randall has smoked ten marijuana cigarettes a
day during that period without any evidence of adverse mental or physical effects
from it.
34. John C. Merritt. M.D •• an expert in ophthalmology. who has
treated Robert Randall and others with marijuana for glaucoma, accepts marijuana
as being safe for use in such treatment.
35. Deborah B.

Goldb~rg.

M.D., fonnerly a researcher in oncology and

now a practicing physician, having worked with many cancer· patients, observed
them, and heard many tell of smoking marijuana successfully to control emesis,
accepts marijuana as proven to be an extremely safe anti-emetic agent.

When

compared with the other. highly toxic chemical substances routinely prescribed
to cancer patients, Dr. Goldberg accepts marijuana as clearly safe for use under
medical supervision.
36.

(See finding 17, above.)

Ivan Silverberg, M.D •• board certified in oncology and practicing

that specialty in the San Francisco area, has accepted marijuana as a safe
antt-emitic when used under medical supervision. Although illegal, it is
commonly used by patients in the San Francisco area with the knowledge and
acquiesence of their doctors who readily accept it as being safe for such use.
37.

It can be inferred that all of the doctors and other health care

professionals referred to in the findings in Sections V, VI and VII, above, who
tolerate or permit patients to self-addminister illegal marijuana for therapeutic
benefit, accept the substance as safe for use under medical supervision.

- 64 -

Discussion
The Act, at 21

u.s.c.

§ 812{b)(l)(C), requires that marijuana be retained

in Schedule I if "[t]here is a lack of accepted safety for use of [it] under
medical supervision.•

If there is no lack of such safety,· if it is accepted

that this substance can be used with safety under medical supervision, then it
is unreasonable to keep .it in Schedule I,
Again we must ask - "accepted" by whom?

In the MOMA proceeding the Agency's

first Final Rule decided that "accepted" here meant, as in the phrase "accepted
medical use in treatment", that the FDA had accepted the substance pursuant to
the provisions of the Food, Drug and Cosmetic Act. 51 Fed. Reg. 36555 (1986).
The Court of Appeals held that this was error.

On remand, in its third Final

Rule on MOMA, the Agency made the same ruling as before, relying essentially on
the same findings, and on others of similar nature, just as it did with respect
to •accepted medical use."

53 Fed. Reg. 5156 (1988).

The administrative law judge finds himself constrained not to follow the
rationale in that MOMA third Final Order for the same reasons as set out above
in Section V with respect to "accepted medical use" in oncology.
to 33.

See pages 30

Briefly, the Agency was looking primarily at the results of scientific

tests and studies rather than at what physicians had, in fact, accepted. The
Agency was wrongly basing its decision on a judgement as to whether or not
doctors ought to have accepted the substance in question as safe for use under
medical supervision.

The criteria the Agency applied in the MOMA third Final

Rule are inappropriate. The only proper question for the Agency here is: Have a
significant minority of physicians accepted marijuana as safe for use under
medical supervision?

- 65 -

The gist of the Agency's case against recognizing marijuana's acceptance as
safe is to assert that more studies, more tests are needed.

The Agency has

presented highly qualified and respected experts, researchers and others, who
hold that view. But, as demonstrated in the discussion in Section V abqve, it
is unrealistic and unreasonable to require unanimity of opinion on the question
confronting us.

For the reasons there indicated, acceptance by a significant

minority of doctors is all that can reasonably be required.

This record makes

it abundantly clear that such acceptance exists in the United States.
Findings are made above with respect to the safety of medically supervised
use of marijuana by glaucoma patients.

Those findings are relevant to the safety

issue even though the administrative law judge does not find accepted use in
treatment of glaucoma to have been shown.
Based upon the facts established in this record and set out above one must
reasonably conclude that there is accepted safety for use of marijuana under
medical supervision.

To conclude otherwise, on this record, would be unreasonable,

arbitrary and capricious.

- 66 -

IX.
CONCLUSION
ANO
RECOMMENDED DECISION
Based upon the foregoing facts and reasoning, the admi ni strati ve l<iw judge
concludes that the provisions of the Act permit and require the transfer of
marijuana from Schedule I to Schedule II. The judge realizes that strong
' emotions are
marijuana.

arou~ed

on both sides of any discussion concerning the use of

Nonetheless it is essential for this Agency, and its Administrator,

calmly and dispassionately to review the evidence of record, correctly apply the
law, and act accordingly.
Marijuana can be harmful.

Marijuana is abused. But the same is true of

dozens of drugs or substances which are listed in Schedule II so that they can
be employed in treatment by physicians in proper cases,, despite their abuse
potenial.
Transferring marijuana from Schedule I to Schedule II will not, of course,.
make it immediately available in pharmacies. throughout the country for legitimate use in treatment.

Other government authorities, Federal and State, will

doubtless have to act before that might occur. But this Agency is not charged
with responsibility, or given authority, over the 111Yriad other regulatory
decisions that may be required before marijuana can actually be legally available.

This Agency is charged merely with determining the placement of marijuana

pursuant to the provisions of the Act. Under our system of laws the responsibilities of other regulatory bodies are the concerns of those bodies, not of
this Agency.
There are those who, in all sincerety, argue that the transfer of marijuana
- 67 -

to Schedule II will "send a signal" that marijuana is "OK" generally for
recreational use.

This argument is specious.

It presents no valid reason for

refraining from taking an action required by law in light of the evidence.
marijuana should be placed in Schedule II, in obedience to the law,

the~

If

that is

where marijuana should be placed, regardless of misinterpretation of the placement by some. The reasons for the placement can, and should, be clearly explained
at the time the action is taken.

The fear of sending such a signal cannot be

permitted to ov.erride the legitimate need, amply demonstrated in this record, of
countless suffers for the relief marijuana can provide when prescribed by a
physician in a legitimate case.
The evidence in this record clearly shows that marijuana has been accepted
as capable of relieving the distress of great numbers of very ill people, and
doing so with safety under medical supervision.

It would be unreasonable,

arbitrar.y and capricious for DEA to· continue to stand between those sufferers
and the benefits of this substance in light of the evidence in this record.
The administrative law judge recommends that the Administrator conclude
that the marijuana plant considered as a whole has a currently accepted medical
use in treatment in the.United States, that there is no lack of accepted safety
for use of it under medical supervision and that it may lawfully be transferred
from Schedule I to Schedule II.

The judge recommends that the Administrator

transfer marijuana from Schedule I to Schedule II.
Dated:

SEP 6 1988

ranc1s
Adminis
.. ··.·~:.... -.. ·.~-· .

- 68 -

CERTIFICATION OF SERVICE
This is to certify that the undersigned on
copy of the foregoing to be delivered to

SEP 6

1988

, caused a

Madeleine R. Shirley, Esq.
Office of Chief Counsel
Drug Enforcement Administration
1405 I Street, N.W.
Washington, D.C. 20537
and caused a copy to be mailed, postage paid, to each of the following:
National Organization for the
Reform of Marijuana Laws
Attn: Kevin B. Zeese, Esq.
Zwerling, Mark, Ginsbe~and Lieberman, P.C.
1001 Duke Street
.
Alexandria, Virginia 22313
National Federation of Parents
for Drug-Free Youth
Attn: Karl Bernstein
Vice President
8730 Georgia Avenue
Suite 200
Silver Spring, Maryland 20910

Carl Eric 01 sen
Post Office Box 5034
Des Moines, Iowa 50306
Cannabis Corporation of
America
Attn: Laurence O. McKinney
President
c/o McKinney &Company
881 Massachusetts Avenue
Cambridge, Massachusetts 02139
International Association of
Chiefs of Police
Attn: Virginia Peltier, Esq.
Assistant Legal Counsel
13 Firstfield Road
P.O. Box 6010
Gaithersburg, Maryland 20878

. Alliance for Cannabis Therapeutics
C/O Frank B. Stilwell, III, Esq.
· Steptoe & Johnson
Attorneys at Law
1330 Connecticut Avenue, N.W.
Washington, D.C. 20036
David c. Beck, Esq.
McDermott, Will & Emery
1850 K Street, N.W.
Washington, D.C. 20006
Attorney for Cannabis Corporation
of America

;(SlgnedE
Dianne L. Martin
Hearing Cl erk

- 6g -