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UNITED STATES DEPARTMENT OF JUSTICE
Drug Enforcement Administration
_______________________________________
)
In The Matter Of )
) Docket No. 86-22
MARIJUANA RESCHEDULING PETITION )
_______________________________________)
OPINION AND RECOMMENDED RULING, FINDINGS OF
FACT, CONCLUSIONS OF LAW AND DECISION OF
Administrative LAW JUDGE.
FRANCIS L. YOUNG, Administrative Law Judge
DATED: SEP 6 1988
UNITED STATES DEPARTMENT OF JUSTICE
Drug Enforcement Administration
_______________________________________
)
In The Matter Of )
) Docket No. 86-22
MARIJUANA RESCHEDULING PETITION )
_______________________________________)
OPINION AND RECOMMENDED RULING, FINDINGS OF
FACT, CONCLUSIONS OF LAW AND DECISION OF
ADMINISTRATIVE LAW JUDGE.
FRANCIS L. YOUNG, Administrative Law Judge
APPEARANCES:
KEVIN B. ZEESE, Esq.
ARNOLD S. TREBACH, Esq.
for National Organization For The Reform of
Marijuana Laws
FRANK B. STILWELL, III, Esq.
for Alliance for Cannabis Therapeutics
DAVID C. BECK, Esq.
for Cannabis Corporation of America
CARL ERIC OLSEN, Pro Se
CHARLOTTE J. MAPES, Esq.
MADELEINE R. SHIRLEY, Esq.
for the Government
KARL BERNSTEIN
for National Federation of Parents for Drug-Free Youth
VIRGINIA PELTIER, Esq.
for the International Association of Chiefs of Police
DATED: SEP 6 1988
CONTENTS
I. INTRODUCTION 1
II. RECOMMENDED RULING 7
III. ISSUES 7
IV. STATUTORY REQUIREMENTS FOR SCHEDULING 8
V. ACCEPTED MEDICAL USE IN TREATMENT
- CHEMOTHERAPY 10
Findings of Fact 10
Discussion 26
VI. ACCEPTED MEDICAL USE IN TREATMENT
- GLAUCOMA 35
Findings of Fact 35
Discussion 38
VII. ACCEPTED MEDICAL USE IN TREATMENT
- MULTIPLE SCLEROSIS, SPASTICITY &
HYPERPARATHYROIDISM 40
Findings of Fact 40
Discussion 54
VIII. ACCEPTED SAFETY FOR USE UNDER MEDICAL
SUPERVISION 56
Findings of Fact 56
Discussion 65
IX. CONCLUSIONS AND RECOMMENDED DECISION 67
CERTIFICATION OF SERVICE 69
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UNITED STATES DEPARTMENT OF JUSTICE
Drug Enforcement Administration
_______________________________________
)
In The Matter Of )
) Docket No. 86-22
MARIJUANA RESCHEDULING PETITION )
_______________________________________)
OPINION AND RECOMMENDED RULING, FINDINGS OF
FACT, CONCLUSIONS OF LAW AND DECISION OF
ADMINISTRATIVE LAW JUDGE.
1.
INTRODUCTION
This is a rulemaking pursuant to the Administrative Procedure Act, 5
U.S.C. § 551, et seq., to determine whether the marijuana plant (Cannabis
sativa L) considered as a whole may lawfully be transferred from Schedule
I to Schedule II of the schedules established by the Controlled
Substances Act (the Act), 21 U.S.C. § 801, et 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 to the
Administrator of DEA. 28 C.F.R. § 0.100, et seq.
agency to the Drug Enforcement Administration (DEA or the Agency), asking
that marijuana be removed from Schedule I and freed of all controls
entirely, or be transferred from Schedule I to Schedule V where it would
be subject to only minimal controls. The Act by its terms had placed
marijuana in Schedule I thereby declaring, as a matter of law that it had
no legitimate use in therapy in the United States and subjecting the
substance to the strictest level of controls. The Act had been in effect
for just over one year when NORML submitted its 1972 petition.
On September 1, 1972 the Director of BNDD announced his refusal to
accept the petition for filing, stating that he was not authorized to
institute proceedings for the action requested because of the provisions
of the Single Convention on Narcotic Drugs, 1961. NORML appealed this
action to the United States Court of Appeals for the District of Columbia
Circuit. The court held that the Director had erred in rejecting the
petition without "a reflective consideration and analysis," observing
that the 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 remanded the
matter in January 1974 for further proceedings not inconsistent with its
opinion, "to be denominated a consideration on the merits." Id.
A three-day hearing was held at DEA [footnote 2] by Administrative
Law Judge Lewis Parker in January 1975. The judge found in NORML's favor
on several issues but the Acting Administrator of DEA entered a final
order denying NORML's petition "in all respects." NORML again petitioned
the 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).
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with DEA's final order the court again remanded for further proceedings
not inconsistent 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
for scientific and medical evaluation. On June 4, 1979 the Secretary of
HEW advised the Administrator of the results of the HEW evaluation and
recommended that marijuana remain in Schedule I. Without holding any
further hearing the Administrator of DEA proceeded to issue a final order
ten days later denying NORML's petition and declining to initiate
proceedings to transfer 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
the then-present status of the matter. DEA had moved for a partial
remand. The court found that "reconsideration of all the issues in this
case would be appropriate" and again remanded it to DEA, observing: "We
regrettably find it necessary to remind respondents [DEA and HEW] of an
agency's obligation on remand not to 'do anything which is contrary to
either the letter or spirit of the mandate construed in the light of the
opinion of [the] court deciding the case.'" (Citations omitted.) NORML
v. DEA, et al., No. 79.1660, United States Court of Appeals for the
District of Columbia Circuit, unpublished order filed October 16, 1980.
DEA was directed to refer all the substances at issue to the Department
of Health and Human Services (HHS), successor agency to HEW, for scien-
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tific 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
was published in the Federal Register on June 24, 1986 announcing that
hearings would be held on NORML's petition for the rescheduling of
marijuana and its components commencing on August 21, 1986 and giving any
interested person who desired to participate the opportunity to do so.
51 Fed. Reg. 22946 (1986).
Of the three original petitioning organizations in 1972 only NORML
is a party to the present proceeding. In addition the following entities
responded to the Federal Register notice and have become parties,
participating to varying degrees: the Alliance for Cannabis Therapeutics
(ACT), Cannabis Corporation of America (CCA) and Carl Eric Olsen, all
seeking transfer of marijuana to Schedule II; the Agency, National
Federation of Parents for Drug free Youth (NFP) and the International
Association of Chiefs of Police (IACP), all contending that marijuana
should remain in Schedule I.
Preliminary prehearing sessions were held on August 21 and December
5, 1986 and on February 20, 1987. [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.
At a prehearing conference on February 20, 1987 this amended
petition was
_______________
3 Transcripts of these three preliminary prehearing sessions are
included in the record.
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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 or physical
dependence. They then agreed that the principal issue in this proceeding
would be stated thus:
Whether the marijuana plant, considered as a whole, [footnote
5] may
________________
4 The transcript of this prehearing conference and of the subsequent
hearing session comprise 15 volumes numbered as follows:
Vol. I - Prehearing 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
Pages of the transcript are cited herein by volume and page, e.g. "Tr. V-
96"; "G-" identifies an Agency exhibit.
5 Throughout this opinion the term marijuana" refers to "the marijuana
plant, consider as a whole".
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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.
As stated above, the parties favoring transfer from Schedule I to
Schedule II are NORML, ACT, CCA and Carl Eric Olsen. Those favoring
retaining marijuana in Schedule I are the Agency, NFP and IACP.
During the Spring and Summer of 1987 the parties identified their
witnesses and put the direct examination testimony of each witness in
writing in affidavit form. Copies of these affidavits were exchanged.
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 witnesses
were subjected to cross-examination. These sessions were held in New
Orleans, Louisiana on November 18 and 19, 1987; in San Francisco,
California on December 8 and 9, 1987; and in Washington, D.C. on January
5 through 8 and 26 through 29, and on February 2, 4 and 5, 1988. The
parties have submitted proposed findings and conclusions and briefs.
Oral arguments were heard by the judge on June 10, 1988 in Washington.
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II.
RECOMMENDED RULING
It is recommended that the proposed findings and conclusions
submitted by the parties to the administrative law judge be rejected by
the Administrator except to the extent they are included in those
hereinafter set forth; 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).
III.
ISSUES
As noted above, the agreed issues are as follows:
Principle issue:
Whether the marijuana plant, considered as a whole, may
lawfully be transferred from Schedule I to Schedule II of
the schedules established by the Controlled Substances Act.
Subsidiary issues:
1. Whether the marijuana plant has a currently accepted
medical use in treatment in the United States, or a
currently accepted medical use with severe restrictions.
2. Whether there is a lack of accepted safety for use of
the marijuana plant under medical supervision.
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IV.
STATUTORY REQUIREMENTS FOR SCHEDULING
The Act provides (21 U.S.C. § 812(b)) that a drug or other substance
may not be placed in any schedule unless certain specified findings are
made with respect to it. The findings required for Schedule I and
Schedule II are as follows:
Schedule I. -
(A) The drug or other substance has a high potential
for abuse.
(B) The drug or other substance has no currently accepted
medical use in treatment in the United States.
(C) There is a lack of accepted safety for use of the
drug or other substance under medical supervision.
Schedule II. -
(A) The drug or other substance has a high potential for
abuse.
(B) The drug or other substance has a currently accepted
medical use in treatment in the United States or a currently
accepted medical use with severe restrictions.
(C) Abuse of the drug or other substances [sic] may lead to
severe psychological or physical dependence.
As noted above the parties have stipulated, for the purpose of this
proceeding, that marijuana has a high potential for abuse and that abuse
of it may lead to severe psychological or physical dependence. Thus the
dispute between the two sides in this proceeding is narrowed to whether
or not marijuana has a currently accepted medical use in treatment in the
United States, and whether or not there is a lack of accepted safety for
use of marijuana under medical supervision.
The issues as framed here contemplate marijuana's being placed only
in
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Schedule I or Schedule II. The criteria for placement in any of the
other three schedules established by the Act are irrelevant to this
proceeding.
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V.
ACCEPTED MEDICAL USE IN TREATMENT
- CHEMOTHERAPY
With respect to whether or not marijuana has a "currently accepted
medical use in treatment in the United States" for chemotherapy patients,
the record shows the following facts to be uncontroverted.
Findings Of Fact
1. One of the most serious problems experienced by cancer
patients undergoing chemotherapy for their cancer is severe nausea and
vomiting caused by their reaction to the toxic (poisonous) chemicals
administered to them in the course of this treatment. This nausea and
vomiting at times becomes 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
and vomiting.
2. Young patients generally achieve better control over nausea
and vomiting from smoking marijuana than do older patients, particularly
when the older patient has not been provided with detailed information on
how to smoke marijuana.
3. Marijuana cigarettes in many cases are superior to
synthetic THC capsules in reducing chemotherapy-induced nausea and
vomiting. Marijuana
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cigarettes have an important, clear advantage over synthetic THC capsules
in that the natural marijuana is inhaled and generally takes effect more
quickly than the synthetic capsule which is ingested and must be
processed through the digestive system before it takes effect.
4. Attempting to orally administer the synthetic THC capsule
to a vomiting patient presents obvious problems - it is vomited right
back up before it can have any effect.
5. Many physicians, some engaged in medical practice and some
teaching in medical schools, have accepted smoking marijuana as effective
in controlling or reducing the severe nausea and vomiting (emesis)
experienced by some cancer patients undergoing chemotherapy for cancer.
6. Such physicians include board-certified internists,
oncologists and psychiatrists. (Oncology is the treatment of cancer
through the use of highly toxic chemicals, or chemotherapy.)
7. Doctors who have come to accept the usefulness of marijuana
in controlling or reducing emesis resulting from chemotherapy have dose
so as the result of reading reports of studies and anecdotal reports in
their professional literature, and as the result of observing patients
and listening to reports directly from patients.
8. Some cancer patients who have acknowledged to doctors that
they smoke marijuana for emesis control have indicated in their
discussions that, although they may have first smoked marijuana
recreationally, they accidentally found that doing so helped reduce the
emesis resulting from their chemotherapy. They consistently indicated
that they felt better and got symptomatic relief from the intense nausea
and vomiting caused by the chemotherapy. These patients
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were no longer simply getting high, but were engaged in medically
treating their illness, albeit with an illegal substance. Other
chemotherapy patients began smoking marijuana to control their emesis
only after hearing reports that the practice had proven helpful to
others. Such patients had not smoked marijuana recreationally.
9. This successful use of marijuana has given many cancer
chemotherapy patients a much more positive outlook on their overall
treatment, once they were relieved of the debilitating, exhausting and
extremely unpleasant nausea and vomiting previously resulting from their
chemotherapy treatment.
10. In about December 1977 the previously underground patient
practice of using marijuana to control emesis burst into the public media
in New Mexico when a young cancer patient, Lynn Pearson, began publicly
to discuss his use of marijuana. Mr. Pearson besought the New Mexico
legislature to pass 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 need.
11. In many cases doctors have found that, in addition to
suppressing nausea and vomiting, smoking marijuana is a highly successful
appetite stimulant. The importance of appetite stimulation in cancer
therapy cannot be overstated. Patients receiving chemotherapy often lose
tremendous amounts of weight. They endanger their lives because they
lose interest in food and in eating. The resulting sharp reduction in
weight may well affect their prognosis. Marijuana smoking induces some
patients to eat. The benefits are obvious, doctors have found. There is
no significant loss of weight. Some patients will gain weight.
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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 found.
12. Synthetic anti-emetic agents have been in existence and
utilized for a number of years. Since about 1980 some new synthetic
agents have been developed which appear to be more effective in
controlling and reducing chemotherapy-induced nausea and vomiting than
were some of those available in the 1970's. But marijuana still is found
more effective for this purpose in some people than any of the synthetic
agents, even the newer ones.
13. By the late 1970's in the Washington, D.C. area there was a
growing recognition among health care professionals and the public that
marijuana had therapeutic value in reducing the adverse effects of some
chemotherapy treatments. With this increasing public awareness came
increasing pressure from patients on doctors for information about
marijuana and its therapeutic uses. Many patients moved into forms of
unsupervised self-treatment. While such self-treatment often proved very
effective, it has certain hazards, ranging from arrest for purchase or
use of an illegal drug to possibly serious medical complications from
contaminated sources or adulterated materials. Yet, some patients are
willing to run these risks to obtain relief from the debilitating nausea
and vomiting caused by their chemotherapy treatments.
14. Every oncologist known to one Washington, D.C. practicing
internist and board-certified oncologist has had patients who used
marijuana with great success to prevent or diminish chemotherapy-induced
nausea and vomiting. Chemotherapy patients reporting directly to that
Washington doctor that they
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have smoked marijuana medicinally vomit less and eat better than patients
who do not smoke it. By gaining control over their severe nausea and
vomiting these patients undergo a change of mood and have a better mental
outlook than patients who, using the standard anti-emetic drugs, are
unable to gain such control.
15. The vomiting induced by chemotherapeutic drugs may last up
to four days following the chemotherapy treatment. The vomiting can be
intense, protracted and, in some instances, is unendurable. 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
using marijuana 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 particularly true
for younger cancer patients, somewhat less common for
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older ones. By 1979 about 25% to 30% of the patients seen by one San
Francisco oncologist were using marijuana to control emesis, about 45 to
50 patients per year. Such percentages and numbers vary from city to
city. A doctor in Kansas City who sees about 150 to 200 new cancer
patients per year found that over the 15 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
tool, commonly employed, in the medical treatment of chemotherapy
patients. There has evolved an unwritten but accepted standard of
treatment within the community of oncologists in the San Francisco,
California area which readily accepts the use of marijuana.
19. As of the Spring of 1987 in the San Francisco area,
patients receiving chemotherapy commonly smoked marijuana in hospitals
during their treatments. This in-hospital use, which takes place in
rooms behind closed doors, does not bother staff, is expected by
physicians and welcomed by nurses who, instead of having to run back and
forth with containers of vomit, can treat patients whose emesis is better
controlled than it would be without marijuana. Medical institutions in
the Bay area where use of marijuana obtained on the streets is quite
common, although discrete, include the University of California at San
Francisco Hospital, the Mount Zion Hospital and the Franklin Hospital.
In effect, marijuana is readily accepted throughout the oncologic
community in the bay area for its benefits in connection with
chemotherapy. The same situation exists in other large metropolitan
areas of the United States.
20. About 50% of the patients seen by one San Francisco
oncologist
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