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OPINION AND RECOMMENDED RULING, FINDINGS OF FACT, CONCLUSIONS
OF LAW AND DECISION OF Administrative LAW JUDGE.
FRANCIS L. YOUNG, Administrative Law Judge
STATES DEPARTMENT OF JUSTICE
Drug Enforcement Administration
In The Matter Of Docket No. 86-22
MARIJUANA RESCHEDULING PETITION
SEP 6 1988
FRANCIS L. YOUNG, Administrative Law Judge
B. ZEESE, Esq.
ARNOLD S. TREBACH, Esq. for National Organization For The
FRANK B. STILWELL, III, Esq. for Alliance for
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
SEP 6 1988
II. RECOMMENDED RULING
REQUIREMENTS FOR SCHEDULING
V. ACCEPTED MEDICAL USE IN TREATMENT
Findings of Fact
VI. ACCEPTED MEDICAL USE IN TREATMENT
Findings of Fact
VII. ACCEPTED MEDICAL
USE IN TREATMENT
- MULTIPLE SCLEROSIS, SPASTICITY &
Findings of Fact
VIII. ACCEPTED SAFETY FOR USE UNDER
Findings of Fact
AND RECOMMENDED DECISION
CERTIFICATION OF SERVICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
OPINION AND RECOMMENDED RULING, FINDINGS OF
FACT, CONCLUSIONS OF LAW AND
ADMINISTRATIVE LAW JUDGE.
This is a rulemaking pursuant to the Administrative Procedure Act, 5
§ 551, et seq., to determine whether the marijuana plant (Cannabis
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 seq. 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, 1972 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)
[footnote 1], predecessor
1 The powers and authority granted by the
Act to the Attorney General
were delegated to the Director of BNDD and subsequently
Administrator of DEA. 28 C.F.R. § 0.100, et seq.
to the Drug Enforcement Administration (DEA or the Agency), asking
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 1972
On September 1, 1972 the Director of BNDD announced his refusal to
the petition for filing, stating that he was not authorized to
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 Director'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
matter in January 1974 for further proceedings not inconsistent
opinion, "to be denominated a consideration on the merits."
A three-day hearing was held at DEA [footnote 2] by Administrative
Lewis Parker in January 1975. The judge found in NORML's favor
issues but the Acting Administrator of DEA entered a final
NORML's petition "in all respects." NORML again petitioned
court for review. Finding fault
2 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).
final order the court again remanded for further proceedings
with its opinion. NORML v. DEA, 182 U.S. App. D.C. 114,
559 F.2d 735 (1977).
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 rulemaking 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
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 marijuana from Schedule
I. 44 Fed. Reg. 36123
(1979). NORML went back to the Court of Appeals.
When the case was called for oral argument there was discussion of
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
of Health and Human Services (HHS), successor agency to HEW,
scientific and medical findings and recommendations on scheduling. DEA
did so and HHS has responded. In a letter dated April 1, 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
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
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
should remain in Schedule I.
pre-hearing sessions were held on August 21 and December
5, 1986 and on February
20, 1987. [footnote 3] During the preliminary
stages, on January 20, 1987,
NORML filed an amended petition for
rescheduling. This new petition abandoned
NORML's previous requests for
the complete descheduling of marijuana or rescheduling
to Schedule V. It
asks only that marijuana be placed in Schedule II.
a pre-hearing conference on February 20, 1987 this amended
Transcripts of these three preliminary pre-hearing sessions are
in the record.
discuss. [footnote 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
dependence. They then agreed that the principal issue in this
would be stated thus:
Whether the marijuana plant, considered as a whole, [footnote
4 The transcript of this pre-hearing conference and of the subsequent
hearing session comprise 15 volumes numbered as follows:
Vol. I - Pre-hearing Conference, October 16, 1987
Vol. II - Cross Examination, November 19, 1987
Vol. III - Cross Examination, December 8, 1987
Vol. IV - Cross Examination, December 9, 1987
Vol. V - Cross Examination, January 5, 1988
Vol. VI - Cross Examination, January 6, 1988
Vol. VII - Cross Examination, January 7, 1988
Vol. VIII - Cross Examination, January 26, 1988
Vol. IX - Cross Examination, January 27, 1988
Vol. X - Cross Examination, January 28, 1988
Vol. XI - Cross Examination, January 29, 1988
Vol. XII - Cross Examination, February 2, 1988
Vol. XIII - Cross Examination, February 4, 1988
Vol. XIV - Cross Examination, February 5, 1988
Vol. XV - Oral Argument, June 10, 1988
of the transcript are cited herein by volume and page, e.g. "Tr. V-
96"; "G-" identifies an Agency exhibit.
Throughout this opinion the term marijuana" refers to "the marijuana
plant, consider as a whole".
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:
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.
stated above, the parties favoring transfer from Schedule I to
are NORML, ACT, CCA and Carl Eric Olsen. Those favoring
in Schedule I are the Agency, NFP and IACP.
During the Spring and Summer of 1987 the parties identified their
and put the direct examination testimony of each witness in
writing in affidavit
form. Copies of these affidavits were exchanged.
Similarly, the parties assembled
their proposed exhibits and exchanged
copies. Opportunity was provided for
each party to submit objections to
the direct examination testimony and exhibits
proffered by the others.
The objections submitted 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
were subjected to cross-examination. These sessions were held in
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
have submitted proposed findings and conclusions and briefs.
were heard by the judge on June 10, 1988 in Washington.
It is recommended that the proposed findings and conclusions
the parties to the administrative law judge be rejected by
except to the extent they are included in those
hereinafter set forth; for
the reason that they are irrelevant or unduly
repetitious or not supported
by a preponderance of the evidence. 21
C.F.R. § 1316.65(a)(1).
As noted above, the agreed issues are as follows:
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
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.
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
with respect to it. The findings required for Schedule I and
are as follows:
Schedule I. -
(A) The drug or other substance has a high potential
(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
(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
or physical dependence.
As noted above the parties have stipulated, for the purpose of this
that marijuana has a high potential for abuse and that abuse
of it may lead
to severe psychological or physical dependence. Thus the
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
The issues as framed here contemplate marijuana's being placed only
I or Schedule II. The criteria for placement in any of the
other three schedules
established by the Act are irrelevant to this
MEDICAL USE IN TREATMENT
With respect to whether or not marijuana has a "currently accepted
use in treatment in the United States" for chemotherapy patients,
record shows the following facts to be uncontroverted.
1. One of the most serious problems experienced by cancer
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 life 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 communication
in the United
States concerning patients known by their doctors to be surreptitiously
using marijuana with notable success to overcome or lessen their nausea
2. Young patients generally achieve better control over nausea
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 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
medical schools, have accepted smoking marijuana as effective
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,
7. Doctors who have come to accept the usefulness of marijuana
or reducing emesis resulting from chemotherapy have dose
so as the result
of reading reports of studies and anecdotal reports in
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
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. 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
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
10. In about December 1977 the previously underground patient
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
legislation 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
11. In many cases doctors have found that, in addition to
and vomiting, smoking marijuana is a highly successful
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. The benefits are obvious,
doctors have found. There is
no significant loss of weight. Some patients
will gain weight.
This allows them to retain strength and makes them
better able to fight
the cancer. Psychologically, 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
12. Synthetic anti-emetic agents have been in existence and
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
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
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
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
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
and, in some instances, is unendurable. The nausea
which follows such vomiting
is also deep and prolonged. 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
to control emesis by the early 1970'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
for younger cancer patients, somewhat less common for
ones. By 1979 about 25% to 30% of the patients seen by one San
oncologist were using marijuana to control emesis, about 45 to
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 years 1972 to 1987 about 5% of
the patients he saw, or a
total of about 75, used marijuana medicinally.
18. By 1987 marijuana no longer generated the intense interest
in the world
of oncology that it had previously, but it remains a viable
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,
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
the Bay area where use of marijuana obtained on the streets
common, although discrete, include the University of California
Francisco Hospital, the Mount Zion Hospital and the Franklin Hospital.
In effect, marijuana is readily accepted throughout the oncologic
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
the year l987 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
to cancer patients pursuant to an act of the State
legislature. The legislature
had accepted marijuana as having medical
use in treatment. It overwhelmingly
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,
medical supervision, to control or reduce emesis. The
marijuana was in
the form of cigarettes obtained from the Federal government.
operated from 1979 until 1986, when funding for it was terminated
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
patients during that period. All of the oncologists in New Mexico
marijuana as effective for some of their patients. At least ten
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 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. Physicians
were aware that this was going on.
22. In 1978 the Louisiana legislature became one of the first-
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,
be obtained legally only for use in cumbersome, formal research
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,
study. The original purpose of the Louisiana legislation was
the Federal authorities. Some patients, who had hoped to
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.
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 oncologist and other
Georgia physician, including the Chief of
oncology at Grady Hospital and
staff oncologist at Emory University Medical
Clinic. Sponsors of the
legislation originally 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
was crafted, however, of necessity, merely to set up a
in order to obtain marijuana from the one legitimate source
the Federal Government, which would not make the substance available
any other 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 44 evaluable marijuana smoking patient-
accepted marijuana smoking as being an effective anti-
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.
None of them
made any comment. The marijuana was completely successful with
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 hours after that chemotherapy treatment. The
thereafter always smoked marijuana, in the hospital, before
The doctors were aware of it, openly approved of it and
encouraged him to
continue. The patient resumed eating regular meals and
regained lost eight,
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
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
found a minor conspiracy to break the law among oncologists
and nurses in
every oncology center he has visited to let patients smoke
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 obtained
marijuana for patients unable to
obtain it for themselves.
27. A cancer patient residing in Beaverton, Michigan smoked
in the nearby hospital where he was undergoing
chemotherapy from early 1979
until he died of his cancer in October of
that year. 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. His parents accepted his marijuana smoking as effective and helpful.
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
medicinally approved, accepting marijuana's therapeutic
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
marijuana for legitimate medical applications and prohibit
its use in
29. In Denver, Colorado a teenage cancer patient has been
to control nausea and vomiting since 1986. He has done
this in his hospital
room both before and after chemotherapy. His doctor
and hospital staff know
he does this. The doctor has stated that he would prescribe marijuana for this
patient if it were legal to do so. Other patients in the Denver area smoke marijuana
for the same purpose. This patient's doctor, and nurses with whom he comes in
contact, understand that cancer patients smoke marijuana to reduce or control
emesis. They accept it.
30. In late 1980 a three year old boy was brought by his parents to a hospital
in Spokane, Washington. The child was diagnosed as having cancer. Surgery was
performed. Chemotherapy was begun. The child became extremely nauseated and vomited
for days after each chemotherapy treatment. He could not eat regularly. He lost
strength. He lost weight. His body's ability to ward off common infections, other
life-threatening infections, significantly decreased. Chemotherapy's after-effects
caused the child great suffering. They caused his watching parents great suffering.
Several standard, available anti-emetic agents were tried by the child's doctors.
None of them succeeded in controlling his nausea or vomiting. 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
personnel to handle it.
31. The child's mother read an article about marijuana smoking
patients. She obtained some marijuana from friends.
She baked cookies for
her child with marijuana in them. She made tea for
him with marijuana in
it. When the child ate these cookies or drank this
tea in connection with
his chemotherapy, he did not vomit. His strength
returned. He regained lost
weight. His spirits revived. The parents
told the doctors and nurses at the
hospital of their giving marijuana to
their child. None objected.
all accepted smoking marijuana as effective in controlling
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
hospital shortly after his chemotherapy treatments while
other children there
were still vomiting into pans, tied to intravenous
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
marijuana to other parents. They approved. They never told
parents to hide their son's medicinal use of marijuana. They accepted
the effectiveness of the cookies and the tea containing marijuana.
33. The first child's cancer went into remission. Then it
returned and spread.
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
children after chemotherapy and the first child.
parents asked the parents of the first child about it, were told of
of marijuana, tried it with their children, and saw dramatic
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 don't need a federal agency to tell you
marijuana is effective. The evidence
is in front of you, so stark it
cannot be ignored." [footnote 6]
34. There is at least one hospital in Tucson, Arizona where
of marijuana by chemotherapy patients is encouraged by the
and some physicians.
35. In addition to the physicians mentioned in the Findings
oncologists and other practitioners, the following doctors
and health care
professionals, representing several different areas of
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
b. Dr. Daniel Danzak, psychiatrist and former head of the
New Mexico program
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.
e. Dr. John Morgan, psychopharmacologist, Board-certified
in Internal Medicine,
full Professor and Director of Pharmacology at the
City University of New
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
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
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, ethnopharmacologist, Associate
Director of Social Perspectives
in Medicine at the College of Medicine at
the University of Arizona, with
extensive research on medicinal plants;
j. Dr. Lester Grinspoon, a practicing psychiatrist and
at Harvard Medical School.
36. Certain law enforcement authorities have been outspoken in
of marijuana as an antiemetic agent. Robert T. Stephan,
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. They had accepted marijuana
having medical use in treatment. He was elected Vice President of the
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 marijuana
available on prescription to cancer and
glaucoma patients. The resolution
was adopted by an overwhelming margin.
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,
statement emphasizing that the proposed rescheduling of marijuana
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 medical
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
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. 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.
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. Medical faculty professors accept it. Nurses performing
hands-on patient care accept it.
Patients accept it. As counsel for CCA perceptively pointed out at
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. They 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
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
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 1970 preceding 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 . . . is not made by any part
of the federal government. It is made by the medical community as to whether or
not the drug has medical use or doesn't". [footnote 7]
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. Seldom, if ever, do all lawyers agree on a point of law.
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 plebiscite of all
doctors in the country on such a question every time it arises, to obtain a majority
In determining whether a medical procedure utilized by a doctor is
as malpractice the courts have adopted the rule what it is acceptable for a doctor
to employ a method of treatment supported by a respectable minority of physicians.
Drug Abuse Control Amendments - 1970: Hearings on H.R. 11701 and
Before the Subcommittee on Public Health and Welfare of
the House Committee
on Interstate and Foreign Commerce, 91st
Congress, 2d Sess. 678, 696, 718
(1970) (Statement of John E.
Ingersoll, Director, BNDD).
In Hood v. Phillips, 537 S.W. 2d 291 (1976) the Texas Court of Civil
was dealing with a claim of medical malpractice resulting from a
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
of physicians in the United States,
cannot be said to be an inappropriate
method of treat-
ment 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
at 294. Noting that the Federal District court in the Arizona case
a "respectable minority" composed of sixty-five physicians
the United States, the Texas court adopted as "the better
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.
In Chumbler v. McClure, 505 F.2d 489 (6th Cir. 1974) the Federal
dealing with a medical malpractice case under their diversity
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 medical authority, it is not
malpractice to be among the minority in a given city who follow: one of the accepted
F.2d at 492 (Emphasis added). See, also, Leech v. Bralliar, 275
How do we ascertain whether there exists a school of thought
responsible medical authority, and thus "accepted"? We
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
proper standard of measurement is to be established
of physicians, for it is a medical
v. Brown, 133 S.E. 2d. 102 (Ga., 1963) at 105.
As noted above, there is no question but that this record shows a
physicians, and others, to have "accepted" marijuana as having
a medical use in the treatment of cancer patients' emesis. True, all
have not "accepted" it. But to require universal, 100%
would be unreasonable. Acceptance by "a respectable minority"
physicians is all that can reasonably be required. The record here
conclusively that at least "a respectable minority" of
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
whether a drug has an "accepted medical use in treatment" in
Matter Of MDMA Scheduling, Docket No. 84-48. The Administrator, in
final rule in that proceeding, issued on October 8, 1986
[footnote 8], declined
to adopt this approach. 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 . . . ." [footnote 9]
The United States Court of Appeals for the First Circuit held that
erred in so ruling. [footnote 10] That court vacated
the final order of October
8, 1986 and remanded the matter of MDMA'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 rule [footnote 11] of the matter of the
MDMA the Administrator made a series of findings of fact as
to MDMA, 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. [footnote 12]
Ibid., at 36558.
Grinspoon v. Drug Enforcement Administration, 828 F.2d 881 (1st.
53 Fed. Reg. 5156 (1988). A second final rule had been issued on
20, 1988. It merely removed MDMA 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 MDMA in Schedule
I. There was no further appeal.
In neither the first nor the third final rule in the MDMA case does
take any cognizance of the statements to the
Congressional committee 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 BNDD
were mistaken or to explain why he now has abandoned
They wrote that language into the original
third final rule dealing with MDMA is dealing with a synthetic,
"single-action" drug. What might be appropriate criteria for a
"simple" drug like MDMA may not be appropriate for a "complex"
with a number of active components. The criteria applied to MDMA,
synthetic drug, are not appropriate for application to marijuana, which
is a natural plant substance.
The First Circuit Court of Appeals in the MDMA case told the
that he should not treat the absence of FDA interstate
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 application (NDA)
or of an investigational new drug exemption
(IND). These requirements
deal with data resulting from controlled studies
conducted investigations and test.
Among those findings incorporated into the third final MDMA order
first, and relied on by the Administrator, was the determination
of the FDA that the drug there in question was not
In relying on the FDA's action the Administrator apparently
fact that the FDA clearly stated that it was interpreting
medical use" in the Act as being equivalent to receiving FDA
for lawful marketing under the FDCA. Thus the Administrator
accepted as a
basis for his MDMA third final rule the FDA recommendation
which was based
upon a statutory interpretation which the Court of Appeals had condemned.
The Administrator in that third final rule made a series of further
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 MDMA third
final order reveals
that the Administrator was really considering the
question: Should the drug
be accepted for medical use?; rather than the
question: 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, MDMA
ought to be accepted for medical use in treatment.
The Agency's arguments in the present case are to the same effect.
In a word,
they address the wrong question. It is not for this Agency to
whether they should or should not accept a drug or substance
use. The statute directs the Administrator merely to
ascertain whether, in
fact, doctors have done so.
The MDMA third final order mistakenly looks to FDA criteria for
in choosing criteria for DEA to apply. Under the Food, Drug and
Act the FDA is deciding - properly, under that statute - whether
a new drug
should be introduced into interstate commerce. Thus it is
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 judgment on its intrinsic qualities. The DEA, on the other hand,
is charged by 21 U.S.C. § 812(b)(1)(B) and (2)(B) with ascertaining what
it is that other people have done with respect to a drug or substance: "Have
they accepted it?;" not "Should they accept it?"
the MDMA third final order DEA is actually making the decision
have to make, rather than trying to ascertain the decision
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.
It is entirely proper for the Administrator to consider the
of a drug and scientific test results in connection with
potential. But abuse potential is not in issue in this
There is another reason why DEA should not be guided by FDA criteria
whether or not marijuana has an accepted medical use in
criteria are applied by FDA pursuant to Section 505 of
the Federal Food,
Drug and Cosmetic Act (FDCA), as amended. [footnote 13]
When the FDA is making
an inquiry pursuant to that legislation it is
looking at a synthetically
formed new drug. The marijuana plant is
anything but a new drug. Uncontroverted
evidence in this record
indicates that marijuana was being used therapeutically
by mankind 2000
years before the Birth of Christ. [footnote 14]
Uncontroverted evidence further establishes that in this country
drugs" are developed by pharmaceutical companies possessing
sufficient to bear the enormous expense of testing a new drug,
FDA approval of its efficacy and safety, and marketing it
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 conceded that "the FDA
system is constructed for
pharmaceutical companies. I won't deny that." [footnote 15]
21 U.S.C. § 355.
Alice M. O'Leary, direct, par. 9.
Since the substance being considered in this case is a natural plant
than a synthetic drug, it is unreasonable to make FDA-type
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
that the Administrator retain marijuana in Schedule I.
But, as in the MDMA
case, that recommendation 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 MDMA case. See
Attachment A, p.24, to exhibit G-1 and exhibit G-2.
The overwhelming preponderance of the evidence in this record
that marijuana has a currently accepted medical use in
treatment in the United
States for nausea and vomiting resulting from
chemotherapy treatments in
some cancer patients. To conclude otherwise,
on this record, would be unreasonable,
arbitrary and capricious.
MEDICAL USE IN TREATMENT
Findings of Fact
The preponderance of the evidence establishes the following facts
to the accepted medical use of marijuana in the treatment of
1. Glaucoma is a disease of the eye characterized by the
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
invasive surgery. Newer, non-invasive procedures such as laser
are thought by some to offer much greater efficacy with
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.
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
- 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 im portant
place in the
treatment of "End Stage" glaucoma. "End Stage" glaucoma,
essentially, defines a patient who has already lost substantial amounts
vision; available glaucoma control drugs are no longer able adequately
reduce the intraocular pressure (IOP) to prevent further, progressive
loss; the patient, lacking additional IOP reductions, will go blind.
6. Robert S. Hepler, M.D., is a highly qualified and
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
effectively reduced Robert Randall's IOP into the safe range over
entire test day. He concluded that the only known alternative to
preserve Randall's sight which would avoid the significant risks of
is to include marijuana as part of Randall's prescribed medical
He further concluded in 1977 that, if marijuana could have been
he would have prescribed it for Randall as part of
Randall's regular glaucoma
maintenance program had he been Randall's
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
subject of an
Ophthalmology Grand Rounds at the University of California,
A questionnaire was distributed which queried the
ophthalmologists on cannabis
therapy for glaucoma patients refractory to
standard treatment. Many of them
have glaucoma patients who have asked
about marijuana. Most of the responding
ophthalmologists believed that
THC capsules or smoked marijuana need to be
available for patients who
have not benefited significantly from standard
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
above, the testimony of patients in this record establishes
that no more
than three or four other physicians consider marijuana to be
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
IOP in some glaucoma patients. There is continuing research
underway in the
United States as to the therapeutic effect of marijuana
Petitioners' briefs fail to show that the preponderance of the
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
of the ophthalmologists who testified that they accept marijuana
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
There is a great volume of evidence here, and much discussion in the
about the protracted case of Robert Randall. But when all is
said and done,
his experience presents but one case. The record contains
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
other glaucoma patients. Their case histories are impressive, but
to the carrying of Petitioner's burden of showing that marijuana
for medical treatment of glaucoma by a respectable minority
See pages 26-29, above.
Petitioners have in evidence copies of a number of newspaper
statements by persons claiming that marijuana has
helped their glaucoma.
The administrative law judge is unable to give
significant weight to this
evidence. Had these persons testified so as
to have been subject to cross-examination,
a different situation would be
presented. But these newspaper reports of
neither tested by informed inquiry nor supported
by a doctor's opinion,
are not entitled to much weight. They are of little,
Beyond the evidence referred to above there is a little other "hard"
evidence, pointed out by petitioners, of Physicians accepting marijuana
for treatment of glaucoma. Such evidence as that concerning a survey of
group of San Francisco ophthalmologists is ambiguous, at best. The
document establishes merely that most of the doctors on the
who responded to an inquiry, believed that the THC capsules
ought to be available.
In sum, the evidence here tending to show that marijuana is accepted
treatment of glaucoma falls far, far short of quantum of evidence
to show that marijuana is accepted for treatment of emesis in
The preponderance of the evidence here, identified by
petitioners in their
briefs, does not establish that a respectable
minority of physicians has
accepted marijuana for glaucoma treatment.
MEDICAL USE IN TREATMENT
MULTIPLE SCLEROSIS, SPASTICITY
Findings Of Fact
The preponderance of the evidence clearly establishes the following
with respect to marijuana's use in connection with multiple
1. Multiple sclerosis is the major cause of neurological
young and middle-aged adults in the United States today.
It is a life-long
disease. 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
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 obstructions 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
contraction of muscle or muscle fibers. (Spasticity can
also result from
serious injuries to the spinal cord, not related to
3. The symptoms of multiple sclerosis vary according to the
area of 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
stiffness, spasticity, weakness of limbs, sexual dysfunction,
and impaired bladder and bowel functions.
4. Each person afflicted by multiple sclerosis is affected
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. At this time, there is no known prevention or cure for
Instead, there are only treatments for the symptoms
of the disease. There
are very few drugs specifically designed to treat
spasticity. These drugs
often cause very serious side effects. At the
present time two drugs are
approved by FDA as "safe" and "effective" for
indication of spasticity. These drugs are Dantrium and
6. Unfortunately, neither Dantrium nor Lioresal is a very
control drug. Their marginal medical utility, high
toxicity and potential
for serious adverse effects make these drugs
difficult to use in spasticity
7. As a result, many physicians routinely prescribe
relaxants, mood elevators and sedatives such as
Valium to patients experiencing
spasticity. While these drugs do not
directly reduce spasticity 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
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
totally disabled. To move about her home she had to sit on a
and push herself around. She spent most of her time in bed or
9. An occasional marijuana smoker in her teens, before her
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
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
she did so it controlled her vomiting, stopped the
nausea and increased her
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
career of her Navy officer husband, Mrs. Cover stopped
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 1987 Mrs. Cover had resumed
smoking marijuana regularly on an
"as needed" basis. Her multiple
sclerosis symptoms are under excellent
control. She has obtained a full-time
job. She still needs a wheelchair
on rare occasions, but generally 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
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 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
found that smoking marijuana improved the quality of her life,
spasms under control. Her balance improved. She seldom
needed to use her
cane for support. Her condition lately has deteriorated. As of May l987 she was
experiencing severe, painful spasms. She had an indwelling catheter in her bladder.
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,
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
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
18. Another drug prescribed for her was Lioresal, intended to
spasms. It was not very effective in doing. But it did cause
Ms. Hirsch to
have hallucinations. On two occasions, while using this
drug, Ms. Hirsch
"saw" a large fire in her bedroom and called for help.
no fire. She stopped using that drug. 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 the FDA for
her. He replied that the paperwork was
"overwhelming". He indicated
willingness to put the paper work together.
20. When Greg Paufler was in his early twenties, employed by
Company, he began to experience the first symptoms
of multiple sclerosis.
His condition worsened as the disease intensified. He had to be hospitalized.
He lost the ability to walk, to stand. Diagnosed as having multiple sclerosis,
a doctor prescribed ACTH for him, an intensive form of steroid therapy. He lost
all control over his limbs and experienced severe, painful spasms. His arms and
legs became numb.
21. ACTH had no beneficial effects. The doctor continued to
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 possibility
of sudden heart attack or
death due to respiratory failure. 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.
Throughout, the spasms continued and Paufler's limbs remained out of control.
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
22. One day Paufler became semi-catatonic while sitting in his
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.
Paufler resolved to take no more steroids.
23. From time to time, prior to this point, Paufler had smoked
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. He began
discontinuing it for a while, then
24. Paufler found that when he did not smoke marijuana his
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.
central field blindness cleared up. He could focus well enough to
One evening he went out with his children and found he could
kick a soccer
25. Paufler has smoked marijuana regularly since 1980. Since
that time his
multiple sclerosis has been well controlled. His doctor
has been astonished
at Paufler's recovery. Paufler can now run. He can
stand on one foot with
his eyes closed. The contrast with his condition,
several years ago, seems
miraculous. Smoking marijuana when Paufler
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
possibility 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
in court when charged with using or possessing marijuana. He
doctors, researchers and other multiple sclerosis patients
Diana's position in the court proceeding.
27. Irwin Rosenfeld has been diagnosed as having Pseudo Pseudo
This uncommon disease causes bone spurs to appear
and grow all over the body.
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. Even without development of a malignancy, the disease
pain. The 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, 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.
were prescribed for him for pain relief. He was taking
narcotics. 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
30. At college in Florida Rosenfeld was introduced to marijuana
He experimented with it recreationally. He never
experienced a "high"
or "buzz" or "floating sensation" from it. One day
smoked marijuana while playing chess with a friend. It had been very
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 marijuana, 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.
was - there was a drastic decrease in Rosenfeld's need for such
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
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
was therapeutically helpful to Rosenfeld and submitted an
to FDA to obtain supplies of it legally for Rosenfeld.
The doctor has insisted,
however, that he not be publicly identified.
After some effort the IND application
was granted. Rosenfeld is
receiving supplies of marijuana from NIDA. Rosenfeld
testified before a
committee of the Virginia legislature in about 1979 in
legislation to make marijuana available for therapeutic purposes
33. In 1969, at age 19, David Branstetter dove into the shallow
end of a
swimming pool and broke his neck. He became a quadriplegic,
over the movement of his arms and legs. After being
hospitalized for 18 months
he returned home. 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. He
stopped taking Valium for fear of the consequences
addiction. His spasms then became uncontrollable, often becoming
they would throw him from his wheelchair.
34. In about 1973 Branstetter began smoking marijuana
discovered that his severe spasms stopped whenever he
Valium, which only masked his symptoms and caused him to feel
drunk and out
of control, marijuana brought his spasmodic condition under
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. In 1979 Branstetter was arrested and convicted of
possession of marijuana.
He was placed on probation for two years.
During that period he continued
smoking marijuana and truthfully reported
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. 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
while several, directly and indirectly, have encouraged him to
Branstetter knows of almost 20 other patients, paraplegics,
and multiple sclerosis sufferers, who smoke marijuana to
control their spasticity.
40. In 1981 a State of Washington Superior Court judge, sitting
jury, found Samuel D. Diana not guilty of the charge of
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
hearing, tendency to vomit in the mornings and stiffness in
the joints of
his hands and legs.
41. Among the witnesses was a physician who had examined
before and after he had used marijuana. This doctor
testified 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
testified in detail as to marijuana's beneficial effect on
42. In acquitting defendant Diana of unlawful possession of
trial judge found that the three requirements for the
defense of medical
necessity had been established, namely: defendant's
reasonable belief that
his 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,
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 quadriplegia 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 patients,
Veterans Hospitals, routinely smoke marijuana to reduce
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
using marijuana. FDA refused but, for reasons
unknown to him, allowed 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
of spasticity in the United States. If it were legally
available 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,
who also teaches at the University of Arizona College of
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
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
the disease but it does relieve the symptoms of spasticity.
50. Dr. John P. Morgan, board certified in internal medicine,
Medicine and Director of Pharmacology at CCNY Medical School
in New York
and Associate Professor of Medicine and Pharmacology at Mt.
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
Based upon the rationale set out in pages 26 to 34, above, the
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 the United States" for spasticity resulting from multiple
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
Rosenfeld suffers. His disease is so rare, and so few physicians
be familiar with it, that acceptance by one doctor of marijuana
useful in treating it ought to satisfy the requirement for a
minority. The Agency points to no evidence of record tending
that marijuana is not accepted by doctors in connection with this most unusual
Refusal to acknowledge acceptance by a significant minority, in
the case history detailed in this record, would be unreasonable,
arbitrary and capricious.
SAFETY FOR USE UNDER MEDICAL SUPERVISION
With respect to whether or not there is "a lack of accepted safety
use of [marijuana] under medical supervision", the record shows the
following facts to be uncontroverted.
Findings of Fact
1. Richard J. Gralla, M.D., 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
2. Andrew T. Weil, M.D., who now practices medicine in Tucson,
is on the faculty of the College of Medicine, University of
a member of the first team of researchers to perform a
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
3. The most obvious concern when dealing with drug safety is
of lethal effects. Can the drug cause death?
4. 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
5. This is a remarkable statement. First, the record on
5,000 years of human experience. Second, marijuana
is now used daily by enormous
numbers of people throughout the world.
Estimates suggest that from twenty
million to fifty million Americans
routinely, albeit illegally, 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
6. By contrast aspirin, a commonly used, over-the-counter
hundreds of deaths each year.
7. Drugs used in medicine are routinely given what is called
an LD-50. 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
stated, researchers have been unable to give animals enough
8. At present it is estimated that marijuana's LD-50 is around
1:40,000. 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. NIDA-supplied
weigh approximately .9 grams. A smoker would
theoretically have to consume
nearly 1,500 pounds of marijuana within
about fifteen minutes to induce a
9. In practical terms, marijuana cannot induce a lethal
response as a result
of drug-related toxicity.
10. Another common medical way to determine drug safety is
called the therapeutic
ratio. This ratio defines the difference between
a therapeutically effective
dose and a dose which is capable of inducing
11. A commonly used over-the-counter product like aspirin has a
ratio of around 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 internal bleeding.
12. The therapeutic ratio for prescribed drugs is commonly
around 1:10 or
lower. Valium, a commonly used prescriptive drug, may
cause very serious
biological damage if patients use ten times the
13. There are, of course, prescriptive drugs which have much
ratios. Many of the drugs used to treat patients with
cancer, glaucoma and
multiple sclerosis are highly toxic. The
therapeutic ratio of some 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
also have very low LD-50
ratios and can result in toxic, even lethal reactions,
14. By contrast, marijuana's therapeutic ratio, like its LD-50,
to quantify because it is so high.
15. In strict medical terms marijuana is far safer than many
foods we commonly
consume. For example, eating ten raw potatoes can
result in a toxic response.
By comparison, it is physically impossible
to eat enough marijuana to induce
16. Marijuana, in its natural form, is one of the safest
active substances known to man. By any measure of rational analysis
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 chemo-
therapeutic agents used on humans
- may cause deafness;
may lead to life-threatening kidney difficulties and
kidney failure; adversely affects the body's immune
system, suppressing the
patient'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
lead slips during treatment and
this drug gets on or under the skin the patient
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.,
Cyoxin, also known as Cyclophosphanide -
suppresses patient's immune system
in serious bone marrow depletion; studies indicate
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 muscle.
each of these agents has its particular adverse effects, as
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 is a very real possibility with
all of these agents and the margin
for error is minimal. Similarly,
there is a danger of overdosing a patient
weakened by his cancer. Put
simply, there is very great risk associated with
the medical 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
have smoked marijuana. These have occurred in marijuana-
naive persons, usually
older persons, who are extremely anxious over the
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
would be reduced in number and severity.
19. Other reported side effects of marijuana have been minimal.
often results. Sometimes mild euphoria is experienced. 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
as an agent under medical supervision.
20. All drugs have "side effects" and all drugs used in
for their therapeutic benefits have unwanted, unintended,
21. In medical treatment "safety" is a relative term. A drug
"safe" for use in treating a life-threatening disease might be
"unsafe" if prescribed for a patient with a minor ailment. The concept
of drug "safety" is relative. Safety is measured against the
consequences a patient would confront in the absence of therapy. The
of "safety" is made in terms of
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
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,
incapacitating condition. Glaucoma assaults and destroys the
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 wholly 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 retraining, 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
place, hold meaningful jobs, but many aspects of the life
they once took
for granted cannot be recaptured. Other patients may never
to their new, uncertain circumstances.
24. Blindness is a very grave consequence. Protecting patients
is considered so important that, for ophthalmologists
generally, it justifies
the use of toxic medicines and uncertain surgical
procedures which in other
contexts might be considered "unsafe." In
often provide glaucoma patients with drugs which
have many serious adverse
25. There are only a limited number of drugs available for the
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
26. The adverse physical consequences resulting from the
chronic use of commonly
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,
decreases in heart rate and pulse, disruption of heart function,
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
patient's kidneys or result in death due to heart failure. Timolol and
related beta-blocking agents, the most recently approved family of
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
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-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, gastric irritation, abdominal
cramps, speech disturbances, seizure, visual disturbances, diplopia, tachycardia,
erratic blood pressure, mental confusion, clinical depression, renal disturbances,
myalgia, feelings of suffocation and death due to liver
29. The adverse effects associated with Lioresal baclofen are
severe, but include possibly lethal consequences, even when
the drug is properly
prescribed and taken as directed. The range on
sublethal toxic reactions
is similar to those found with Dantrium.
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
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.D., a psychiatrist practicing in
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
marijuana for nine years, accepts marijuana as safe for use
by his patient
under medical supervision. Mr. Randall has smoked ten marijuana cigarettes a day
during that period without any evidence of adverse
mental or physical effects
34. John C. Merritt, M.D., an expert in ophthalmology, who has
Randall and others with marijuana for glaucoma, accepts
marijuana as being
safe for use in such treatment.
35. Deborah B. Goldberg, M.D., formerly a researcher in
oncology and now
a practicing physician, having worked with many cancer
them, and heard many tell of smoking marijuana
successfully to control emesis,
accepts marijuana is 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
supervision. (See finding 17, above.)
36. Ivan Silverberg, M.D., board certified in oncology and
specialty in the San Francisco area, has accepted
marijuana as a safe anti-emetic
when used under medical supervision.
Although illegal, it is commonly used
by patients in the San Francisco
area with the knowledge and acquiescence
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
referred to in the findings in Sections V, VI and VII,
above, who tolerate
or permit patients to self-administer illegal
marijuana for therapeutic benefit,
accept the substance as safe for use
under medical supervision.
The Act, at 21 U.S.C. § 812(b)(1)(C), requires that marijuana be
in Schedule I if "[t]here is a lack of accepted safety for use
under medical supervision." If there is no lack of such safety,
is accepted that this substance can be used with safety under
then it is unreasonable to keep it in Schedule I.
Again we must ask - "accepted" by whom? In the MDMA proceeding the
Agency's first Final Rule decided that "accepted" here meant, as in
phrase "accepted medical use in treatment", that the FDA had
substance pursuant to the provisions of the Food, Drug and Cosmetic
51 Fed. Reg. 36555 (1986). The Court of Appeals held that this was
error. On remand, in its third Final Rule on MDMA, the Agency made the
ruling as before, relying essentially on the same findings, and on
of similar nature, just as it did with respect to "accepted
use." 53 Fed. Reg. 5156 (1988).
The administrative law judge finds himself constrained not to follow
rationale in that MDMA third Final Order for the same reasons as set
above in Section V with respect to "accepted medical use" in oncology.
See pages 30 to 33. 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 judgment 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 MDMA 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?
The gist of the Agency's case against recognizing marijuana's
as safe is to assert that more studies, more tests are needed.
has presented highly qualified and respected experts,
researchers and others,
who hold that view. But, as demonstrated in the
discussion in Section V above,
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
Findings are made above with respect to the safety of medically
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
reasonably conclude that there is accepted safety for use of
medical supervision. To conclude otherwise, on this
record, would be unreasonable,
arbitrary and capricious.
Based upon the foregoing facts and reasoning, the administrative law
concludes that the provisions of the Act permit and require the
of marijuana from Schedule I to Schedule II. The Judge realizes
emotions are aroused on both sides of any discussion
concerning the use of
marijuana. 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
Transferring marijuana from Schedule I to Schedule II will not, of
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 myriad 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
other regulatory bodies are the concerns of those bodies, not of this
There are those who, in all sincerity, argue that the transfer of
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
evidence. If marijuana should be placed in Schedule II, in obedience
law, then that is where marijuana should be placed, regardless of
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 override 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
as capable of relieving the distress of great numbers of very
and doing so with safety under medical supervision. It would
arbitrary 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
the marijuana plant considered as a whole has a currently
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
SEP 6 1988
Francis L. Young
Administrative Law Judge
CERTIFICATE OF SERVICE
This is to certify that the undersigned on SEP 6 1988, caused a copy
foregoing to be delivered to
Madeleine R. Shirley, Esq.
Office of Chief Counsel
Drug Enforcement Administration
1405 I Street, N.W.
Washington, D.C. 20537
caused a copy to be mailed, postage paid, to each of the following:
Organization for the Carl Eric Olsen
Reform of Marijuana Laws Post Office
Attn: Kevin B. Zeese, Esq. Des Moines, Iowa 50306
Ginsberg and Lieberman, P.C.
1001 Duke Street Cannabis Corporation of
Alexandria, Virginia 22313 America
Attn: Laurence O. McKinney
Federation of Parents President
for Drug-Free Youth c/o McKinney & Company
Attn: Karl Bernstein 881 Massachusetts Avenue
Vice President Cambridge, Massachusetts
8730 Georgia Avenue
Suite 200 International Association of
Spring, Maryland 20910 Chiefs of Police
Attn: Virginia Peltier, Esq.
for Cannabis Therapeutics Assistant Legal Counsel
c/o Frank B. Stillwell,
III, Esq. 13 Firstfield Road
Steptoe & Johnson P.O. Box 6010
at Law Gaithersburg, Maryland 20878
1330 Connecticut Avenue, N.W.
C. Beck, Esq.
McDermott, Will & Emery
1850 K Street, N.W.
Attorney for Cannabis Corporation of America