Smokin Moose
Fallen Cannabis Warrior & Ex Moderator
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
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
II. RECOMMENDED RULING
III. ISSUES
IV. STATUTORY REQUIREMENTS FOR SCHEDULING
V. ACCEPTED MEDICAL USE IN TREATMENT
- CHEMOTHERAPY
Findings of Fact
Discussion
VI. ACCEPTED MEDICAL USE IN TREATMENT
- GLAUCOMA
Findings of Fact
Discussion
VII. ACCEPTED MEDICAL USE IN TREATMENT
- MULTIPLE SCLEROSIS, SPASTICITY &
HYPERPARATHYROIDISM
Findings of Fact
Discussion
VIII. ACCEPTED SAFETY FOR USE UNDER MEDICAL
SUPERVISION
Findings of Fact
Discussion
IX. CONCLUSIONS AND RECOMMENDED DECISION
CERTIFICATION OF SERVICE
UNITED STATES DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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).
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
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
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 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.
At a pre-hearing conference on February 20, 1987 this amended
petition was
3 Transcripts of these three preliminary pre-hearing sessions are
included 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 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 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
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".
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.
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.
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 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.
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 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 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.
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 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
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 during 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
marijuana available to cancer patients pursuant to an act of the State
legislature. The legislature had accepted marijuana as having medical
use in treatment. It 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, administered under
medical supervision, to control or reduce emesis. The marijuana was in
the form of cigarettes obtained from the Federal government. The program
operated from 1979 until 1986, when funding for it was terminated by the
State. During those seven years about 250 cancer patients in New Mexico
received either marijuana cigarettes or THC. Twenty or 25 physicians in
New Mexico sought and obtained marijuana cigarettes or THC for their
cancer patients during that period. All of the oncologists in New Mexico
accepted marijuana as effective for some of their patients. At least ten
hospitals 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-
State legislatures in the nation to recognize the efficacy of marijuana
in controlling emesis by enacting legislation intended to make marijuana
available by prescription for therapeutic use by chemotherapy patients.
This enactment shows that there was widespread acceptance in Louisiana
of the therapeutic value of marijuana. After a State Marijuana
Prescription Review Board was established, pursuant to that legislation,
it became apparent that, because of Federal restrictions, marijuana could
be obtained legally only for use in cumbersome, formal research programs.
Eventually a research program was entered into by the State, utilizing
synthetic THC, but without much enthusiasm, since most professionals who
had wanted to use marijuana clinically, to treat patients, had neither
the time, resources nor inclination to get involved in this limited,
formal study. The original purpose of the Louisiana legislation was
frustrated by the Federal authorities. Some patients, who had hoped to
obtain marijuana for medical use legally after enactment of the State
legislation, went outside the law and obtained it illicitly. Some
physicians in Louisiana accept marijuana as having a distinct medical
value in the treatment of the nausea and vomiting associated with certain
types of chemotherapy treatments.
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 final legislation
was crafted, however, of necessity, merely to set up a research program
in order to obtain marijuana from the one legitimate source available -
the Federal Government, which would not make the substance available for
any 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-
participants, accepted marijuana smoking as being an effective anti-
emetic agent.
24. In Boston, Massachusetts in 1977 a nurse in a hospital
suggested to a chemotherapy patient, suffering greatly from the therapy
and at the point of refusing further treatment, that smoking marijuana
might help relieve his nausea and vomiting. The patient's doctor, when
asked about it later, stated that many of his younger patients were
smoking marijuana. Those who did so seemed to have less trouble with
nausea and vomiting. The patient in question obtained some marijuana and
smoked it, in the hospital, immediately before his next chemotherapy
treatment. Doctors, nurses, and orderlies coming into the room as he
finished smoking realized what the patient had been doing. None of them
made any comment. The marijuana was completely successful with this
patient, who accepted it as effective in controlling his nausea and
vomiting. Instead of being sick for weeks following chemotherapy, and
having trouble going to work, as had been the case, the patient was ready
to return to work 48 hours after that chemotherapy treatment. The
patient thereafter always smoked marijuana, in the hospital, before
chemotherapy. The doctors were aware of it, openly approved of it and
encouraged him to continue. The patient resumed eating regular meals and
regained lost 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 chemotherapy.
25. During the remaining two years of this patient's life,
before his cancer ended it, he came to know other cancer patients who
were smoking marijuana to relieve the adverse effects of their
chemotherapy. Most of these patients had learned about using marijuana
medically from their doctors who, having accepted its effectiveness,
subtly encouraged them to use it.
26. A Boston psychiatrist and professor, who travels about the
country, has found a minor conspiracy to break the law among oncologists
and nurses in every oncology center he has visited to let patients smoke
marijuana before and during cancer chemotherapy. He has talked with
dozens of these health care oncologists who encourage their patients to
do this and who regard this as an accepted medical usage of marijuana.
He has known nurses who have obtained marijuana for patients unable to
obtain it for themselves.
27. A cancer patient residing in Beaverton, Michigan smoked
marijuana medicinally in the nearby hospital where he was undergoing
chemotherapy from early 1979 until he died of his cancer in October of
that year. 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 smoked marijuana
medicinally approved, accepting marijuana's therapeutic helpfulness in
reducing nausea and vomiting.
28. In October 1979 the Michigan legislature enacted
legislation whose underlying purpose was to make marijuana available
therapeutically for cancer patients and others. The State Senate passed
the bill 29-5, the House of Representatives 100-0. In March 1982 the
Michigan legislature passed a resolution asking the Federal Congress to
try to alter Federal policies which prevent physicians from prescribing
marijuana for legitimate medical applications and prohibit its use in
medical treatments.
29. In Denver, Colorado a teenage cancer patient has been
smoking marijuana to control nausea and vomiting since 1986. He has done
this in his hospital room both before and after chemotherapy. 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
administrative personnel to handle it.
31. The child's mother read an article about marijuana smoking
helping chemotherapy patients. She obtained some marijuana from friends.
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.
They all accepted smoking marijuana as effective in controlling
chemotherapy induced nausea and vomiting. They were interested to see
the results of the cookies.
32. Soon this child was riding a tricycle in the hallways of
the Spokane hospital shortly after his chemotherapy treatments while
other children there were still vomiting into pans, tied to 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 information about
marijuana to other parents. They approved. They never told the first
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 between their
children after chemotherapy and the first child.
Other parents asked the parents of the first child about it, were told of
the use of marijuana, tried it with their children, and saw dramatic
improvement. They accepted its effectiveness. In the words of the
mother of the first child: ". . . When your kid is riding a tricycle
while his other hospital buddies are hooked up to IV needles, their heads
hung over vomiting buckets, you 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
medicinal use of marijuana by chemotherapy patients is encouraged by the
nursing staff and some physicians.
35. In addition to the physicians mentioned in the Findings
above, mostly oncologists and other practitioners, the following doctors
and health care professionals, representing several different areas of
expertise, accept marijuana as medically useful in controlling or
reducing emesis and testified to that effect in these proceedings:
a. George Goldstein, Ph.D., psychologist, Secretary of
Health for the State of New Mexico from 1978 to 1983 and chief
administrator in the implementation of the New Mexico program utilizing
marijuana;
b. Dr. Daniel Danzak, psychiatrist and former head of the
New Mexico program utilizing marijuana;
c. Dr. Tod Mikuriya, psychiatrist and editor of
Marijuana: Medical Papers, a book presenting an historical perspective of
marijuana's medical use;
d. Dr. Norman Zinberg, general psychiatrist and Professor
of Psychiatry at Harvard Medical School since 1951;
6 Affidavit of Janet Andrews, ACT rebuttal witness, par. 98.
e. Dr. John Morgan, psychopharmacologist, Board-certified
in Internal Medicine, full Professor and Director of Pharmacology at the
City University of New York;
f. Dr. Phillip Jobe, neuropsychopharmacologist with a
practice in Illinois and former Professor of Pharmacology and Psychiatry
at the Louisiana State University School of Medicine in Shreveport,
Louisiana, from 1974 to 1984;
g. Dr. Arthur Kaufman, formerly a general practitioner in
Maryland, currently Vice-President of a private medical consulting group
involved in the evaluation of the quality of care of all the U.S.
military hospitals throughout the world, who has had extensive experience
in drug abuse treatment and rehabilitation programs;
h. Dr. J. Thomas Ungerleider, a full Professor of
Psychiatry at the University of California in Los Angeles with extensive
experience in research on the medical use of drugs;
i. Dr. Andrew Weil, ethnopharmacologist, Associate
Director of Social Perspectives in Medicine at the College of Medicine at
the University of Arizona, with extensive research on medicinal plants;
and
j. Dr. Lester Grinspoon, a practicing psychiatrist and
Associate Professor at Harvard Medical School.
36. Certain law enforcement authorities have been outspoken in
their acceptance of marijuana as an antiemetic agent. Robert T. Stephan,
Attorney General of the State of Kansas, and himself a former cancer
patient, said of chemotherapy in his affidavit in this record: "The
treatment becomes a terror." His cancer is now in remission. He came to
know a number of health care professionals whose medical judgment he
respected. They had accepted marijuana
as having medical use in treatment. He was elected Vice President of the
National Association of Attorneys General (NAAG) in 1983. He was
instrumental in the adoption by that body in June 1983 of a resolution
acknowledging the efficacy of marijuana for cancer and glaucoma patients.
The resolution expressed the support of NAAG for legislation then pending
in the Congress to make 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, issued a
statement emphasizing that the proposed rescheduling of marijuana would
in no way affect or impede existing efforts by law enforcement
authorities to crack down on illegal drug trafficking.
37. At least one court has accepted marijuana as having 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
the degree of public acceptance of marijuana as effective in treating
cancer and glaucoma patients. A poll in Nebraska brought slightly over
1,000 responses - 83% favored making marijuana available by prescription,
12% were opposed, 5% were undecided. A poll in Pennsylvania elicited
1,008 responses - 83.1% favored availability by prescription, 12.2% were
opposed, 4.7% were undecided. These two surveys were conducted by professional polling companies. The Detroit Free Press conducted a telephone poll in which 85.4% of those responding favored access to marijuana by prescription. In the State of Washington the State Medical Association conducted a poll in which 80% of the doctors belonging to the Association favored controlled availability of marijuana for medical purposes.
Discussion
From the foregoing uncontroverted facts it is clear beyond any question that many people find marijuana to have, in the words of the Act, an "accepted medical use in treatment in the United States" in effecting relief for cancer patients. Oncologists, physicians treating cancer patients, accept this. Other medical practitioners and researchers accept this. Medical faculty professors accept it. Nurses performing hands-on patient care accept it.
Patients accept it. As counsel for CCA perceptively pointed out at
oral argument, acceptance by the patient is of vital importance. Doctors
accept a therapeutic agent or process only if it "works" for the patient.
If the patient does not accept, the doctor cannot administer the treatment. The patient's informed consent is vital. The doctor ascertains the patient's acceptance by observing and listening to the patient. Acceptance by the doctor depends on what he sees in the patient and hears from the patient. Unquestionably, patients in large numbers have accepted marijuana as useful in treating their emesis. 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
attorneys- general, officials whose primary concern is law enforcement. A large number of them have no fear that placing marijuana in Schedule II, thus
making it available for legitimate therapy, will in any way impede
existing efforts of law enforcement authorities to crack down on illegal
drug trafficking.
The Act does not specify by whom a drug or substance must be "accepted [for] medical use in treatment" in order to meet the Act's "accepted" requirement for placement in Schedule II. Department of Justice witnesses told the Congress during hearings in 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 vote.
In determining whether a medical procedure utilized by a doctor is
actionable 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
H.R. 13743 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
Appeals was dealing with a claim of medical malpractice resulting from a
surgical procedure claimed to have been unnecessary. The court quoted
from an Arizona court decision holding that
a method of treatment, as espoused and used by . . . a
respectable minority of physicians in the United States,
cannot be said to be an inappropriate method of 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 profession generally.
Ibid. at 294. Noting that the Federal District court in the Arizona case
found a "respectable minority" composed of sixty-five physicians
throughout the United States, the Texas court adopted as "the better
rule" to apply in its case, that
a physician is not guilty of malpractice where the
method of treatment used is supported by a respect-
able minority of physicians.
Ibid.
In Chumbler v. McClure, 505 F.2d 489 (6th Cir. 1974) the Federal
courts were dealing with a medical malpractice case under their diversity
jurisdiction, applying Tennessee law, The Court of Appeals said:
. . . The most favorable interpretation that may be placed on the testimony adduced at trial below is that there is a division of opinion in the medical profession regarding the use of Premarin in the Treatment of cerebral vascular insufficiency, and that Dr. McClure was alone among neurosurgeons in Nashville in using such therapy. The test for malpractice and for community standards is not to be determined solely by a plebiscite. Where two or more schools of thought exist among competent members of the medical profession concerning proper medical treatment for a given ailment, each of which is supported by responsible medical authority, it is not malpractice to be among the minority in a given city who follow: one of the accepted schools.
505 F.2d at 492 (Emphasis added). See, also, Leech v. Bralliar, 275
F.Supp. 897 (D.Ariz., 1967).
How do we ascertain whether there exists a school of thought
supported by responsible medical authority, and thus "accepted"? We
listen to the physicians.
The court and jury must have a standard measure
which they are to use in measuring the acts of a
doctor to determine whether he exercised a reasonable
degree of care and skill; they are not permitted to
set up and use any arbitrary or artificial standard
of measurement that the jury may wish to apply. The
proper standard of measurement is to be established
by testimony of physicians, for it is a medical
question.
Hayes v. Brown, 133 S.E. 2d. 102 (Ga., 1963) at 105.
As noted above, there is no question but that this record shows a
great many physicians, and others, to have "accepted" marijuana as having
a medical use in the treatment of cancer patients' emesis. True, all
physicians have not "accepted" it. But to require universal, 100%
acceptance would be unreasonable. Acceptance by "a respectable minority"
of physicians is all that can reasonably be required. The record here
establishes conclusively that at least "a respectable minority" of
physicians has "accepted" marijuana as having a "medical use in treatment
in the United states." That others may not makes no difference.
The administrative law judge recommended this same approach for
determining whether a drug has an "accepted medical use in treatment" in
The Matter Of MDMA Scheduling, Docket No. 84-48. The Administrator, in
his first 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
the Administrator 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
scheduling of 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]
9 Ibid., at 36558.
10 Grinspoon v. Drug Enforcement Administration, 828 F.2d 881 (1st.
Cir., 1987).
11 53 Fed. Reg. 5156 (1988). A second final rule had been issued on
January 20, 1988. It merely removed 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.
12 In neither the first nor the third final rule in the MDMA case does
the Administrator 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
representatives were mistaken or to explain why he now has abandoned
their interpretation. They wrote that language into the original
bill.
That third final rule dealing with MDMA is dealing with a synthetic,
"simple", "single-action" drug. What might be appropriate criteria for a
"simple" drug like MDMA may not be appropriate for a "complex" substance
with a number of active components. The criteria applied to MDMA, a
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
Administrator that he should not treat the absence of FDA interstate
marketing approval as conclusive evidence of lack of currently accepted
medical use. The court did not forbid the Administrator from considering
the absence of FDA approval as a factor when determining the existence of
accepted medical use. Yet on remand, in his third final order, the
Administrator adopted by reference 18 of the numbered findings he had
made in the first final order. Each of these findings had to do with
requirements imposed by FDA for approval of a new drug application (NDA)
or of an investigational new drug exemption (IND). These requirements
deal with data resulting from controlled studies and scientifically
conducted investigations and test.
Among those findings incorporated into the third final MDMA order
from the first, and relied on by the Administrator, was the determination
and recommendation of the FDA that the drug there in question was not
"accepted". In relying on the FDA's action the Administrator apparently
overlooked the fact that the FDA clearly stated that it was interpreting
"accepted medical use" in the Act as being equivalent to receiving FDA
approval for lawful marketing under the FDCA. Thus the Administrator
accepted as a basis for his 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
findings. Again, the central concern in these findings was the content
of test results and the sufficiency or adequacy of studies and scientific
reports. A careful reading of the criteria considered in the 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
tell doctors whether they should or should not accept a drug or substance
for medical use. The statute directs the Administrator merely to
ascertain whether, in fact, doctors have done so.
The MDMA third final order mistakenly looks to FDA criteria for
guidance in choosing criteria for DEA to apply. Under the Food, Drug and
Cosmetic Act the FDA is deciding - properly, under that statute - whether
a new drug should be introduced into interstate commerce. Thus it is
appropriate for the FDA to rely heavily on test results and scientific
inquiry to ascertain whether a drug is effective and whether it is safe.
The FDA must look at a drug and pass 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?"
In the MDMA third final order DEA is actually making the decision
that doctors have to make, rather than trying to ascertain the decision
which doctors have made. Consciously or not, the Agency is undertaking
to tell doctors what they should or should not accept. In so doing the
Agency is acting beyond the authority granted in the Act.
It is entirely proper for the Administrator to consider the
pharmacology of a drug and scientific test results in connection with
determining abuse potential. But abuse potential is not in issue in this
marijuana proceeding.
There is another reason why DEA should not be guided by FDA criteria
in ascertaining whether or not marijuana has an accepted medical use in
treatment. These criteria are applied by FDA pursuant to Section 505 of
the Federal Food, Drug and Cosmetic Act (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
today "new drugs" are developed by pharmaceutical companies possessing
resources sufficient to bear the enormous expense of testing a new drug,
obtaining FDA approval of its efficacy and safety, and marketing it
successfully. No company undertakes the investment required unless it
has a patent on the drug, so it can recoup its development costs and make
a profit. At oral argument Government counsel conceded that "the FDA
system is constructed for pharmaceutical companies. I won't deny that." [footnote 15]
13 21 U.S.C. § 355.
14 Alice M. O'Leary, direct, par. 9.
Since the substance being considered in this case is a natural plant
rather than a synthetic drug, it is unreasonable to make FDA-type
criteria determinative of the issue in this case, particularly so when
such criteria are irrelevant to the question posed by the act: does the
substance have an accepted medical use in treatment?
Finally, the Agency in this proceeding relies in part on the FDA's
recommendation that the Administrator 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
establishes 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.
VI.
ACCEPTED MEDICAL USE IN TREATMENT
GLAUCOMA
Findings of Fact
The preponderance of the evidence establishes the following facts
with respect to the accepted medical use of marijuana in the treatment of
glaucoma.
1. Glaucoma is a disease of the eye characterized by the
excessive accumulation of fluid causing increased intraocular pressure,
distorted vision and, ultimately, blindness. In its early stages this
pressure can sometimes be relieved by the administration of drugs. When
such medical treatment fails adequately to reduce the intraocular
pressure (IOP), surgery is generally resorted to. Although useful in
many cases, there is a high incidence of failure with some types of
surgery. Further, serious complications can occur as a result of
invasive surgery. Newer, non-invasive procedures such as laser
trabeculoplasty are thought by some to offer much greater efficacy with
fewer complications. Unless the IOP is relieved and brought to a
satisfactory level by one means or another, the patient will go blind.
2. Two highly qualified and experienced ophthalmologists in
the United States have accepted marijuana as having a medical use in
treatment for glaucoma. They are John C. Merritt, M.D. and Richard D.
North, M.D. Each of them is both a clinician, treating patients, and a
researcher. Dr. Merritt is also a professor of ophthalmology. Dr. North
has served as a medical officer in ophthalmology for the Department of
Health, Education and Welfare and has worked with the Public Health
Service and FDA.
3. Dr. Merritt's experience with glaucoma patients using
marijuana medicinally includes one Robert Randall and, insofar as the
evidence here establishes per petitioners' briefs, an unspecified number
of other patients, something in excess of 40.
4. Dr. North has treated only one glaucoma patient using
marijuana medicinally - the same Robert Randall mentioned immediately
above. Dr. North had monitored Mr. Randall's medicinal use of marijuana
for nine years as of May 1987
5. Dr. Merritt has accepted marijuana as having an im portant
place in the treatment of "End Stage" glaucoma. "End Stage" glaucoma,
essentially, defines a patient who has already lost substantial amounts
of vision; available glaucoma control drugs are no longer able adequately
to reduce the intraocular pressure (IOP) to prevent further, progressive
sight loss; the patient, lacking additional IOP reductions, will go blind.
6. Robert S. Hepler, M.D., is a highly qualified and
experienced ophthalmologist. He has done research with respect to the
effect of smoking marijuana on glaucoma. In December 1975 he prescribed
marijuana for the same Robert Randall mentioned above as a research
subject. Dr. Hepler found that large dosages of smoked marijuana
effectively reduced Robert Randall's IOP into the safe range over an
entire test day. He concluded that the only known alternative to
preserve Randall's sight which would avoid the significant risks of
surgery is to include marijuana as part of Randall's prescribed medical
regimen. He further concluded in 1977 that, if marijuana could have been
legally prescribed, he would have prescribed it for Randall as part of
Randall's regular glaucoma maintenance program had he been Randall's
personal physician.
Nonetheless, in 1987 Dr. Hepler was of the opinion that marijuana did
not have a currently accepted medical use in the United States for the
treatment of glaucoma.
7. Four glaucoma patients testified in these proceedings.
Each has found marijuana to be of help in controlling IOP.
8. In 1984 the treatment of glaucoma with Cannabis was the
subject of an Ophthalmology Grand Rounds at the University of California,
San Francisco. A questionnaire was distributed which queried the
ophthalmologists on cannabis therapy for glaucoma patients refractory to
standard treatment. 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 treatment.
9. In about 1978 an unspecified number of persons in the
public health service sector in New Mexico, including some physicians,
accepted marijuana as having medical use in treating glaucoma.
10. A majority of an unspecified number of ophthalmologists
known to Arthur Kaufman, M.D., who was formerly in general practice but
now is employed as a medical program administrator, accept marijuana as
having medical use in treatment of glaucoma.
11. In addition to the physicians identified and referred to in
the findings above, the testimony of patients in this record establishes
that no more than three or four other physicians consider marijuana to be
medically useful in the treatment of glaucoma in the United States. One
of those Physicians actually wrote a prescription for marijuana for a
patient, which, of course, she was unable to have filled.
12. There are test results showing that smoking marijuana has
reduced the IOP in some glaucoma patients. There is continuing research
underway in the United States as to the therapeutic effect of marijuana
on glaucoma.
Discussion
Petitioners' briefs fail to show that the preponderance of the
evidence in the record with respect to marijuana and glaucoma establishes
that a respectable minority of physicians accepts marijuana as being
useful in the treatment of glaucoma in the United States.
This conclusion is not to be taken in any way as criticism of the
opinions of the ophthalmologists who testified that they accept marijuana
for this purpose. The failure lies with petitioners. In their briefs
they do not point out hard, specific evidence in this record sufficient
to establish that a respectable minority of physicians has accepted their
position.
There is a great volume of evidence here, and much discussion in the
briefs, about the protracted case of Robert Randall. But when all is
said and done, his experience presents but one case. The record contains
sworn testimony of three ophthalmologists who have treated Mr. Randall.
One of them tells us of a relatively small number of other glaucoma
patients whom he has treated with marijuana and whom he knows to have
responded favorably. Another of these three doctors has successfully
treated only Randall with marijuana. The third testifies, despite his
successful experience in treating Randall, that marijuana does not have
an accepted use in such treatment.
In addition to Robert Randall, Petitioners point to the testimony of
three other glaucoma patients. Their case histories are impressive, but
they contribute
little to the carrying of Petitioner's burden of showing that marijuana
is accepted for medical treatment of glaucoma by a respectable minority
of physicians. See pages 26-29, above.
Petitioners have in evidence copies of a number of newspaper
clippings reporting 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 extra-judicial statements,
neither tested by informed inquiry nor supported by a doctor's opinion,
are not entitled to much weight. They are of little, if any,
materiality.
Beyond the evidence referred to above there is 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
a group of San Francisco ophthalmologists is ambiguous, at best. The
relevant document establishes merely that most of the doctors on the
grand round, who responded to an inquiry, believed that the THC capsules
or marijuana ought to be available.
In sum, the evidence here tending to show that marijuana is accepted
for treatment of glaucoma falls far, far short of quantum of evidence
tending to show that marijuana is accepted for treatment of emesis in
cancer patients. The preponderance of the evidence here, identified by
petitioners in their briefs, does not establish that a respectable
minority of physicians has accepted marijuana for glaucoma treatment.
VII.
ACCEPTED MEDICAL USE IN TREATMENT
MULTIPLE SCLEROSIS, SPASTICITY
AND HYPERPARATHYROIDISM
Findings Of Fact
The preponderance of the evidence clearly establishes the following
facts with respect to marijuana's use in connection with multiple
sclerosis, spasticity and hyperparathyroidism.
1. Multiple sclerosis is the major cause of neurological
disability among young and middle-aged adults in the United States today.
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 initial stages
of the disease nerve impulses are transmitted with only minor interruptions. As the disease progresses, the plaques may completely obstruct the impulses along certain nerve systems. These 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
and abnormal contraction of muscle or muscle fibers. (Spasticity can
also result from serious injuries to the spinal cord, not related to
multiple sclerosis.)
3. The symptoms of multiple sclerosis vary according to the
area of the nervous system which is affected and according to the severity of the disease. The symptoms can include one or more of the following:
weakness, tingling, numbness, impaired sensation, lack of coordination,
disturbances in equilibrium, double vision, loss of vision, involuntary
rapid movement of the eyes (nystagmus), slurred speech, tremors,
stiffness, spasticity, weakness of limbs, sexual dysfunction, paralysis,
and impaired bladder and bowel functions.
4. Each person afflicted by multiple sclerosis is affected
differently. In some persons, the symptoms of the disease are barely
detectable, even over long periods of time. In these cases, the persons
can live their lives as if they did not suffer from the disease. In
others, more of the symptoms are present and acute, thereby limiting
their physical capabilities. Moreover, others may experience sporadic,
but acute, symptoms.
5. At this time, there is no known prevention or cure for
multiple sclerosis. 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
the specific indication of spasticity. These drugs are Dantrium and
Lioresal baclofen.
6. Unfortunately, neither Dantrium nor Lioresal is a very
effective spasm control drug. Their marginal medical utility, high
toxicity and potential for serious adverse effects make these drugs
difficult to use in spasticity therapy.
7. As a result, many physicians routinely prescribe
tranquilizers, muscle relaxants, mood elevators and sedatives such as
Valium to patients experiencing spasticity. While these drugs do not
directly reduce spasticity they may weaken the patient's muscle tone, thus making the spasms less noticeable. Alternatively, they may induce sleep or so tranquilize the patient that normal mental and physical functions are impossible.
8. A healthy, athletic young woman named Valerie Cover was
stricken with multiple sclerosis while in her early twenties. She
consulted several medical specialists and followed all the customary
regimens and prescribed methods for coping with this debilitating disease
over a period of several years. None of these proved availing. Two
years after first experiencing the symptoms of multiple sclerosis her
active, productive life - as an athlete, Navy officer's wife and mother -
was effectively over. The Social Security Administration declared her
totally disabled. To move about her home she had to sit on a skateboard
and push herself around. She spent most of her time in bed or sitting in
a wheelchair.
9. An occasional marijuana smoker in her teens, before her
marriage, she had not smoked it for five years as of February 1986. Then
a neighbor suggested that marijuana just might help Mrs. Cover's multiple
sclerosis, having read that it had helped cancer patient's control their
emesis. Mrs. Cover acceded to the suggestion.
10. Just before smoking the marijuana cigarette produced by her
neighbor, Mrs. Cover had been throwing up and suffering from spasms.
Within five minutes of smoking part of the marijuana cigarette she
stopped vomiting, no longer felt nauseous and noticed that the intensity
of her spasms was significantly reduced. She stood up unaided.
11. Mrs. Cover began smoking marijuana whenever she felt
nauseated. When she did so it controlled her vomiting, stopped the
nausea and increased her 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
jeopardize the career of her Navy officer husband, Mrs. Cover stopped
smoking marijuana several times. Each time she did so, after about a
month, she had retrogressed to the point that her multiple sclerosis
again had her confined to bed and wheelchair or skateboard. As of the
Spring of 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
first exhibited symptoms of multiple sclerosis at age 19 and it was
diagnosed at that time. Her condition has grown progressively worse.
She has been under the care of physicians and hospitalized for treatment.
Many drugs have been prescribed for her by her doctors. At one point in
1983 she listed the drugs that had been prescribed for her. There were 17 on the list. None of them has given her the relief from her multiple sclerosis symptoms that marijuana has.
15. During the early stages in the development of her illness
Ms. Hirsch found that smoking marijuana improved the quality of her life,
keeping her spasms under control. Her balance improved. She seldom
needed to use her cane for support. Her condition lately has deteriorated. As of May 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,
the attendant, treats a number of patients who smoke marijuana for relief
of multiple sclerosis symptoms. In about 1980 another patient told Ms.
Hirsch that he knew many patients who smoke marijuana to relieve their
spasms. Through him she met other patients and found that marijuana was
commonly used by many multiple sclerosis patients. Most of these persons
had told their doctors about their doing so. None of those doctors
advised against the practice and some encouraged it.
17. Among the drugs prescribed by doctors for Ms. Hirsch was
ACTH. This failed to give her any therapeutic benefit or to control her
spasticity. It did produce a number of adverse effects, including severe
nausea and vomiting which, in turn, were partly controlled by rectally
administered anti-emetic drugs.
18. Another drug prescribed for her was Lioresal, intended to
reduce her 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.
There was 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
Prudential Insurance 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
prescribe it 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 eventually substituted.
22. One day Paufler became semi-catatonic while sitting in his
living room at home. He was rushed to the hospital emergency room. He
nearly died. Lab reports indicated, among other things, a nearly total
lack of potassium in his body. He was given massive injections of
potassium in the emergency room and placed on an oral supplement.
Paufler resolved to take no more steroids.
23. From time to time, prior to this point, Paufler had smoked
marijuana socially with visiting friends, seek some relief from his
misery in a temporary "high". He now began smoking marijuana more often.
After some weeks he found that he could stand and then walk a bit. His
doctor dismissed the idea that marijuana could be helpful with multiple
sclerosis, and Paufler, himself, was skeptical at first. He began
discontinuing it for a while, then resuming.
24. Paufler found that when he did not smoke marijuana his
condition worsened, he suffered more intense spasms more frequently.
When he smoked marijuana, his condition would stabilize and then improve;
spasms were more controlled and less severe; he felt better; he regained
control over his limbs and could walk totally unaided. His vision, often
blurred and unfocused, improved. Eventually he began smoking marijuana
on a daily basis. He ventured outdoors. He was soon walking half a
block. His eyesight returned to normal.
His central field blindness cleared up. He could focus well enough to
read again. One evening he went out with his children and found he could
kick a soccer ball again.
25. Paufler has smoked marijuana regularly since 1980. 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
necessity" in court when charged with using or possessing marijuana. He
learned that doctors, researchers and other multiple sclerosis patients
had supported Diana's position in the court proceeding.
27. Irwin Rosenfeld has been diagnosed as having Pseudo Pseudo
Hypoparathyroidism. 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
causes enormous 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.
Various drugs were prescribed for him for pain relief. He was taking
extremely powerful 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
relaxants.
30. At college in Florida Rosenfeld was introduced to marijuana
by classmates. He experimented with it recreationally. He never
experienced a "high" or "buzz" or "floating sensation" from it. One day
he smoked marijuana while playing chess with a friend. It had been very
difficult for him to sit for more than five or ten minutes at a time
because of tumors in the backs of his legs. Suddenly he realized that,
absorbed in his chess game, and smoking 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.
Something
certainly was - there was a drastic decrease in Rosenfeld's need for such
drugs as Dilaudid and Demerol and for sleeping pills. The quality of
pain relief which followed his smoking of marijuana was superior to any
he had experienced before. As his dosages of powerful conventional drugs
decreased, Rosenfeld became less withdrawn from the world, more able to
interact and function. So he has continued to the present time.
32. After some time Rosenfeld's doctor accepted the fact that
the marijuana was therapeutically helpful to Rosenfeld and submitted an
IND application to FDA to obtain supplies of it legally for Rosenfeld.
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 support of
legislation to make marijuana available for therapeutic purposes in that
State.
33. In 1969, at age 19, David Branstetter dove into the shallow
end of a swimming pool and broke his neck. He became a quadriplegic,
losing control 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 of long-term
addiction. His spasms then became uncontrollable, often becoming so bad
they would throw him from his wheelchair.
34. In about 1973 Branstetter began smoking marijuana
recreationally. He discovered that his severe spasms stopped whenever he
smoked marijuana.
Unlike Valium, which only masked his symptoms and caused him to feel
drunk and out of control, marijuana brought his spasmodic condition under
control without impairing his faculties. When he was smoking marijuana
regularly he was more active, alert and outgoing.
35. Marijuana controlled his spasms so well that Branstetter
could go out with friends and he began to play billiards again. The
longer he smoked marijuana the more he was able to use his arms and
hands. Marijuana also improved his bladder control and bowel movements.
36. At times the illegal marijuana Branstetter was smoking
became very expensive and sometimes was unavailable. During periods when
he did not have marijuana his spasms would return, preventing Branstetter
from living a "normal" life. He would begin to shake uncontrollably, his
body would feel tense, and his muscles would spasm.
37. 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
marijuana while several, directly and indirectly, have encouraged him to
continue. Branstetter knows of almost 20 other patients, paraplegics,
quadriplegics and multiple sclerosis sufferers, who smoke marijuana to
control their spasticity.
40. In 1981 a State of Washington Superior Court judge, sitting
without a jury, found Samuel D. Diana not guilty of the charge of
unlawful possession of marijuana. In so doing the judge upheld Diana's
defense of medical necessity. Diana had been a multiple sclerosis
patient since at least 1973. He testified that smoking marijuana
relieved his symptoms of double vision, tremors, unsteady walk, impaired
hearing, tendency to vomit in the mornings and stiffness in the joints of
his hands and legs.
41. Among the witnesses was a physician who had examined
defendant Diana before and after he had used marijuana. This doctor
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 sclerosis who
testified in detail as to marijuana's beneficial effect on their illness.
42. In acquitting defendant Diana of unlawful possession of
marijuana the trial judge found that the three requirements for the
defense of medical necessity had been established, namely: defendant's
reasonable belief that his use of marijuana was necessary to minimize the effects of multiple sclerosis; the benefits derived from its use are greater than the harm sought to be prevented by the controlled substances law; and no drug is as effective as marijuana in minimizing the effects of the disease in the defendant.
43. Denis Petro, M.D., is a neurologist of broad experience,
ranging from active practice in neurology to teaching the subject in
medical school and employment by FDA as a medical officer reviewing IND's
and NDA's. He has also been employed by pharmaceutical companies and has
served as a consultant to the State of New York. He is well acquainted
with the case histories of three patients who have successfully utilized
marijuana to control severe spasticity when other, FDA-approved drugs
failed to do so. Dr. Petro knows of other cases of patients who, he
has determined, have effectively used marijuana to control their spasticity. He has heard reports of additional patients with multiple sclerosis, paraplegia and 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,
particularly in Veterans Hospitals, routinely smoke marijuana to reduce
spasticity. While this mode of treatment is illegal, it is generally
tolerated, if not openly encouraged, by physicians in charge of such
wards who accept this practice as being of benefit to their patients.
There are many spinal cord injury patients in Veterans Hospitals.
45. Dr. Petro sought FDA approval to conduct research with
spasticity patients using marijuana. FDA refused but, for reasons
unknown to him, allowed him to make a study using synthetic THC. He and colleagues made such a study. They concluded that synthetic THC effected a significant reduction in spasticity among multiple sclerosis patients, but study participants who had also smoked marijuana reported consistently that
marijuana was more effective.
46. Dr. Petro accepts marijuana as having a medical use in the
treatment of spasticity in the United States. If it were legally
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,
Arizona, who also teaches at the University of Arizona College of
Medicine, accepts marijuana as having a medical use in the treatment of
spasticity. In multiple sclerosis patients the muscles become tense and
rigid because their nerve supply is interrupted. Marijuana relieves this
spasticity in many patients, he has found. He would prescribe it to
selected patients if it were legally available,
49. Dr. Lester B. Collins, III, a neurologist, then treating
about 20 multiple sclerosis patients a year, seeing two or three new ones
each year, stated in 1983 that he had no doubt that marijuana worked
symptomatically for some multiple sclerosis patients. He said that it
does not alter the course of the disease but it does relieve the symptoms of spasticity.
50. Dr. John P. Morgan, board certified in internal medicine,
Professor of Medicine and Director of Pharmacology at CCNY Medical School
in New York and Associate Professor of Medicine and Pharmacology at Mt.
Sinai School of Medicine, accepts marijuana as having medical use in
treatment in the United States. If he were practicing medicine and
marijuana were legally available he would prescribe it when indicated to
patients with legitimate medical needs.
Discussion
Based upon the rationale set out in pages 26 to 34, above, the
administrative law judge concludes that, within the meaning of the Act,
21 U.S.C. § 812(b)(2)(B), marijuana "has a currently accepted medical use
in treatment in the United States" for spasticity resulting from multiple
sclerosis and other causes. It would be unreasonable, arbitrary and
capricious to find otherwise. The facts set out above, uncontroverted by
the Agency, establish beyond question that some doctors in the United
States accept marijuana as helpful in such treatment for some patients.
The record here shows that they constitute a significant minority of
physicians. Nothing more can reasonably be required. That some doctors
would have more studies and test results in hand before accepting
marijuana's usefulness here is irrelevant.
The same is true with respect to the hyperparathyroidism from which
Irvin Rosenfeld suffers. His disease is so rare, and so few physicians
appear to be familiar with it, that acceptance by one doctor of marijuana
as being useful in treating it ought to satisfy the requirement for a
significant minority. The Agency points to no evidence of record tending
to establish that marijuana is not accepted by doctors in connection with this most unusual ailment.
Refusal to acknowledge acceptance by a significant minority, in light of
the case history detailed in this record, would be unreasonable,
arbitrary and capricious.
VIII.
ACCEPTED SAFETY FOR USE UNDER MEDICAL SUPERVISION
With respect to whether or not there is "a lack of accepted safety
for use of [marijuana] under medical supervision", the record shows the
following facts to be uncontroverted.
Findings of Fact
1. Richard J. Gralla, M.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
side effects.
2. Andrew T. Weil, M.D., who now practices medicine in Tucson,
Arizona and is on the faculty of the College of Medicine, University of
Arizona, was a member of the first team of researchers to perform a
Federal Government authorized study into the effects of marijuana on
human subjects. This team made its study in 1968. These researchers
determined that marijuana could be safely used under medical supervision.
In the 20 years since then Dr. Weil has seen no information that would
cause him to reconsider that conclusion. There is no question in his
mind but that marijuana is safe for use under appropriate medical
supervision.
3. The most obvious concern when dealing with drug safety is
the possibility of lethal effects. 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
cannabis-induced fatality.
5. This is a remarkable statement. First, the record on
marijuana encompasses 5,000 years of human experience. Second, marijuana
is now used daily by enormous 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
single death.
6. By contrast aspirin, a commonly used, over-the-counter
medicine, causes 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 success. Simply
stated, researchers have been unable to give animals enough marijuana to
induce death.
8. At present it is estimated that marijuana's LD-50 is around
1:20,000 or 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
marijuana cigarettes weigh approximately .9 grams. A smoker would
theoretically have to consume nearly 1,500 pounds of marijuana within
about fifteen minutes to induce a lethal response.
9. In practical terms, marijuana cannot induce a lethal
response as a result of drug-related toxicity.
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
adverse effects.
11. A commonly used over-the-counter product like aspirin has a
therapeutic 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
recommended (therapeutic) dose.
13. There are, of course, prescriptive drugs which have much
lower therapeutic ratios. Many of the drugs used to treat patients with
cancer, glaucoma and multiple sclerosis are highly toxic. The
therapeutic ratio of 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, while being
properly employed.
14. By contrast, marijuana's therapeutic ratio, like its LD-50,
is impossible to quantify because it is so high.
15. In strict medical terms marijuana is far safer than many
foods we commonly consume. For example, eating ten raw potatoes can
result in a toxic response. By comparison, it is physically impossible
to eat enough marijuana to induce death.
16. Marijuana, in its natural form, is one of the safest
therapeutically
active substances known to man. By any measure of rational analysis
marijuana can be safely used within a supervised routine of medical care.
17. Some of the drugs most widely used in chemotherapy
treatment of cancer have adverse effects as follows:
Cisplatin, one of the most powerful 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
patient's intravenous lead slips during treatment and
this drug gets on or under the skin the patient may
suffer serious injury including temporary, and in
extreme cases, permanent, loss of use of the arm.
Procarbizine, also used for Hodgkins disease -
has known psychogenic, i.e., emotional, effects.
Cyoxin, also known as Cyclophosphanide -
suppresses patient's immune system response; results
in serious bone marrow depletion; studies indicate
this drug may also cause other cancers, including
cancers of the bladder.
Adriamycan, has numerous adverse effects; is
difficult to employ in long term therapies because it
destroys the heart muscle.
While each of these agents has its particular adverse effects, as
indicated above, they also cause a number of similar, disturbing adverse
effects. Most of these drugs cause hair loss. Studies increasingly
indicate all of these drugs may cause other forms of cancer. Death due
to kidney, heart or respiratory failure 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
patients who have smoked marijuana. These have occurred in marijuana-
naive persons, usually older persons, who are extremely anxious over the
forthcoming chemotherapy and troubled over the illegality of their having
obtained the marijuana. Such persons have responded to simple person-to-
person communication with a doctor and have sustained no long term mental
or physical damage. If marijuana could be legally obtained, and
administered in an open, medically-supervised session rather than
surreptitiously, the few instances of such adverse reaction doubtless
would be reduced in number and severity.
19. Other reported side effects of marijuana have been minimal.
Sedation 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 being employed
as an agent under medical supervision.
20. All drugs have "side effects" and all drugs used in
medicine for their therapeutic benefits have unwanted, unintended,
sometimes adverse effects.
21. In medical treatment "safety" is a relative term. A drug
deemed "safe" for use in treating a life-threatening disease might be
"unsafe" if prescribed for a patient with a minor ailment. The concept
of drug "safety" is relative. Safety is measured against the
consequences a patient would confront in the absence of therapy. The
determination 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
that glaucoma, untreated, progressively destroys the optic nerve and
results in eventual blindness. The danger, then, to patients with
glaucoma is an irretrievable loss of their sight.
23. Glaucoma is not a mortal disease, but a highly specific,
selectively incapacitating condition. Glaucoma assaults and destroys the
patient's most evolved and critical sensory ability, his or her vision.
The vast majority of patients afflicted with glaucoma are adults over the
age of thirty. The onset of blindness in middle age or later throws
patients into a 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 fully adjust
to their new, uncertain circumstances.
24. Blindness is a very grave consequence. Protecting patients
from blindness 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
practice, physicians often provide glaucoma patients with drugs which
have many serious adverse effects.
25. There are only a limited number of drugs available for the
treatment of glaucoma. All of these drugs produce adverse effects.
While several government witnesses lightly touched on the side effects of
these drugs, none provided a full or detailed description of their known
adverse consequences.
26. The adverse physical consequences resulting from the
chronic use of 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, increases and
decreases in heart rate and pulse, disruption of heart function, chronic
and acute renal disease, and bone marrow depletion.
27. Finally, each FDA-approved drug family used in glaucoma
therapy is capable of producing a lethal response, even when properly
prescribed and used. Epinephrine can lead to elevated blood pressure
which may result in stroke or heart attack. Miotic drugs suppress
respiration and can cause respiratory Paralysis. Diuretic drugs so alter
basic body chemistry they cause renal stones and may destroy the
patient's kidneys or result in death due to heart failure. Timolol and
related beta-blocking agents, the most recently approved family of
glaucoma control drugs, can trigger severe asthma attacks or cause death
due to sudden cardiac arrhythmias often producing cardiac arrest.
28. Both of the FDA-approved drugs used in treating the
symptoms of multiple sclerosis, Dantrium and Lioresal, while accepted as
"safe" can, in fact, be very dangerous substances. Dantrium or dantrolene sodium carries a boxed warning in the Physician's Desk Reference (PDR) because of its very high toxicity. Patients using this drug run a very real risk of developing sympto-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
failure.
29. The adverse effects associated with Lioresal baclofen are
somewhat less severe, but include possibly lethal consequences, even when
the drug is properly prescribed and taken as directed. The range 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
and Associate Professor of Medicine at Harvard Medical School, accepts
marijuana as safe for use under medical supervision. He believes its
safety is its greatest advantage as a medicine in appropriate cases.
32. Tod H. Mikuriya, M.D., a psychiatrist practicing in
Berkley, California who treats substance abusers as inpatients and
outpatients, accepts marijuana as safe for use under medical supervision.
33. Richard D. North, M.D., who has treated Robert Randall for
glaucoma with marijuana for nine years, accepts marijuana as safe for use
by his patient under medical supervision. Mr. Randall has smoked ten marijuana cigarettes a day during that period without any evidence of adverse
mental or physical effects from it.
34. John C. Merritt, M.D., an expert in ophthalmology, who has
treated Robert Randall and others with marijuana for glaucoma, accepts
marijuana as being safe for use in such treatment.
35. Deborah B. Goldberg, M.D., formerly a researcher in
oncology and now a practicing physician, having worked with many cancer
patients, observed them, and heard many tell of smoking marijuana
successfully to control emesis, accepts marijuana 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 under medical
supervision. (See finding 17, above.)
36. Ivan Silverberg, M.D., board certified in oncology and
practicing that 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
care professionals 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.
Discussion
The Act, at 21 U.S.C. § 812(b)(1)(C), requires that marijuana be
retained in Schedule I if "[t]here is a lack of accepted safety for use
of [it] under medical supervision." If there is no lack of such safety,
if it is accepted that this substance can be used with safety under
medical supervision, then it is unreasonable to keep it in Schedule I.
Again we must ask - "accepted" by whom? In the MDMA proceeding the
Agency's first Final Rule decided that "accepted" here meant, as in the
phrase "accepted medical use in treatment", that the FDA had accepted the
substance pursuant to the provisions of the Food, Drug and Cosmetic Act.
51 Fed. Reg. 36555 (1986). The Court of Appeals held that this was
error. On remand, in its third Final Rule on MDMA, the Agency made the
same ruling as before, relying essentially on the same findings, and on
others of similar nature, just as it did with respect to "accepted
medical use." 53 Fed. Reg. 5156 (1988).
The administrative law judge finds himself constrained not to follow
the rationale in that MDMA third Final Order for the same reasons as set
out 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
acceptance as safe is to assert that more studies, more tests are needed.
The Agency has presented highly qualified and respected experts,
researchers and others, who hold that view. But, as demonstrated in the
discussion in Section V 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 States.
Findings are made above with respect to the safety of medically
supervised use of marijuana by glaucoma patients. Those findings are
relevant to the safety issue even though the administrative law judge
does not find accepted use in treatment of glaucoma to have been shown.
Based upon the facts established in this record and set out above
one must reasonably conclude that there is accepted safety for use of
marijuana under medical supervision. To conclude otherwise, on this
record, would be unreasonable, arbitrary and capricious.
IX.
CONCLUSION
AND
RECOMMENDED DECISION
Based upon the foregoing facts and reasoning, the administrative law
judge concludes that the provisions of the Act permit and require the
transfer of marijuana from Schedule I to Schedule II. The Judge realizes
that strong emotions are 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 potential.
Transferring marijuana from Schedule I to Schedule II will not, of
course, make it immediately available in pharmacies throughout the
country for legitimate use in treatment. Other government authorities,
Federal and State, will doubtless have to act before that might occur.
But this Agency is not charged with responsibility, or given authority,
over the 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 of
other regulatory bodies are the concerns of those bodies, not of this
Agency,
There are those who, in all sincerity, argue that the transfer of
Marijuana to Schedule II will "send a signal" that marijuana is "OK" generally for recreational use. This argument is specious. It presents no valid reason for refraining from taking an action required by law in light of
the evidence. If marijuana should be placed in Schedule II, in obedience
to the law, then that is where marijuana should be placed, regardless of
misinterpretation of the placement by some. The reasons for the placement can, and should, be clearly explained at the time the action is taken. The fear of sending such a signal cannot be permitted to 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
accepted as capable of relieving the distress of great numbers of very
ill people, and doing so with safety under medical supervision. It would
be unreasonable, 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
conclude that the marijuana plant considered as a whole has a currently
accepted medical use in treatment in the United States, that there is no
lack of accepted safety for use of it under medical supervision and that
it may lawfully be transferred from Schedule I to Schedule II. The judge
recommends that the Administrator transfer marijuana from Schedule I to
Schedule II.
Dated: SEP 6 1988
Francis L. Young
Administrative Law Judge
CERTIFICATE OF SERVICE
This is to certify that the undersigned on SEP 6 1988, caused a copy
of the 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
and caused a copy to be mailed, postage paid, to each of the following:
National Organization for the Carl Eric Olsen
Reform of Marijuana Laws Post Office Box 5034
Attn: Kevin B. Zeese, Esq. Des Moines, Iowa 50306
Zwerling, Mark, Ginsberg and Lieberman, P.C.
1001 Duke Street Cannabis Corporation of
Alexandria, Virginia 22313 America
Attn: Laurence O. McKinney
National Federation of Parents President
for Drug-Free Youth c/o McKinney & Company
Attn: Karl Bernstein 881 Massachusetts Avenue
Vice President Cambridge, Massachusetts 02139
8730 Georgia Avenue
Suite 200 International Association of
Silver Spring, Maryland 20910 Chiefs of Police
Attn: Virginia Peltier, Esq.
Alliance for Cannabis Therapeutics Assistant Legal Counsel
c/o Frank B. Stillwell, III, Esq. 13 Firstfield Road
Steptoe & Johnson P.O. Box 6010
Attorneys at Law Gaithersburg, Maryland 20878
1330 Connecticut Avenue, N.W.
Washington, D.C. 20036
David C. Beck, Esq.
McDermott, Will & Emery
1850 K Street, N.W.
Washington, D.C. 20006
Attorney for Cannabis Corporation of America
Dianne L. Martin
Hearing Clerk
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
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
II. RECOMMENDED RULING
III. ISSUES
IV. STATUTORY REQUIREMENTS FOR SCHEDULING
V. ACCEPTED MEDICAL USE IN TREATMENT
- CHEMOTHERAPY
Findings of Fact
Discussion
VI. ACCEPTED MEDICAL USE IN TREATMENT
- GLAUCOMA
Findings of Fact
Discussion
VII. ACCEPTED MEDICAL USE IN TREATMENT
- MULTIPLE SCLEROSIS, SPASTICITY &
HYPERPARATHYROIDISM
Findings of Fact
Discussion
VIII. ACCEPTED SAFETY FOR USE UNDER MEDICAL
SUPERVISION
Findings of Fact
Discussion
IX. CONCLUSIONS AND RECOMMENDED DECISION
CERTIFICATION OF SERVICE
UNITED STATES DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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).
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
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
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 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.
At a pre-hearing conference on February 20, 1987 this amended
petition was
3 Transcripts of these three preliminary pre-hearing sessions are
included 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 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 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
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".
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.
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.
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 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.
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 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 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.
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 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
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 during 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
marijuana available to cancer patients pursuant to an act of the State
legislature. The legislature had accepted marijuana as having medical
use in treatment. It 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, administered under
medical supervision, to control or reduce emesis. The marijuana was in
the form of cigarettes obtained from the Federal government. The program
operated from 1979 until 1986, when funding for it was terminated by the
State. During those seven years about 250 cancer patients in New Mexico
received either marijuana cigarettes or THC. Twenty or 25 physicians in
New Mexico sought and obtained marijuana cigarettes or THC for their
cancer patients during that period. All of the oncologists in New Mexico
accepted marijuana as effective for some of their patients. At least ten
hospitals 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-
State legislatures in the nation to recognize the efficacy of marijuana
in controlling emesis by enacting legislation intended to make marijuana
available by prescription for therapeutic use by chemotherapy patients.
This enactment shows that there was widespread acceptance in Louisiana
of the therapeutic value of marijuana. After a State Marijuana
Prescription Review Board was established, pursuant to that legislation,
it became apparent that, because of Federal restrictions, marijuana could
be obtained legally only for use in cumbersome, formal research programs.
Eventually a research program was entered into by the State, utilizing
synthetic THC, but without much enthusiasm, since most professionals who
had wanted to use marijuana clinically, to treat patients, had neither
the time, resources nor inclination to get involved in this limited,
formal study. The original purpose of the Louisiana legislation was
frustrated by the Federal authorities. Some patients, who had hoped to
obtain marijuana for medical use legally after enactment of the State
legislation, went outside the law and obtained it illicitly. Some
physicians in Louisiana accept marijuana as having a distinct medical
value in the treatment of the nausea and vomiting associated with certain
types of chemotherapy treatments.
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 final legislation
was crafted, however, of necessity, merely to set up a research program
in order to obtain marijuana from the one legitimate source available -
the Federal Government, which would not make the substance available for
any 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-
participants, accepted marijuana smoking as being an effective anti-
emetic agent.
24. In Boston, Massachusetts in 1977 a nurse in a hospital
suggested to a chemotherapy patient, suffering greatly from the therapy
and at the point of refusing further treatment, that smoking marijuana
might help relieve his nausea and vomiting. The patient's doctor, when
asked about it later, stated that many of his younger patients were
smoking marijuana. Those who did so seemed to have less trouble with
nausea and vomiting. The patient in question obtained some marijuana and
smoked it, in the hospital, immediately before his next chemotherapy
treatment. Doctors, nurses, and orderlies coming into the room as he
finished smoking realized what the patient had been doing. None of them
made any comment. The marijuana was completely successful with this
patient, who accepted it as effective in controlling his nausea and
vomiting. Instead of being sick for weeks following chemotherapy, and
having trouble going to work, as had been the case, the patient was ready
to return to work 48 hours after that chemotherapy treatment. The
patient thereafter always smoked marijuana, in the hospital, before
chemotherapy. The doctors were aware of it, openly approved of it and
encouraged him to continue. The patient resumed eating regular meals and
regained lost 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 chemotherapy.
25. During the remaining two years of this patient's life,
before his cancer ended it, he came to know other cancer patients who
were smoking marijuana to relieve the adverse effects of their
chemotherapy. Most of these patients had learned about using marijuana
medically from their doctors who, having accepted its effectiveness,
subtly encouraged them to use it.
26. A Boston psychiatrist and professor, who travels about the
country, has found a minor conspiracy to break the law among oncologists
and nurses in every oncology center he has visited to let patients smoke
marijuana before and during cancer chemotherapy. He has talked with
dozens of these health care oncologists who encourage their patients to
do this and who regard this as an accepted medical usage of marijuana.
He has known nurses who have obtained marijuana for patients unable to
obtain it for themselves.
27. A cancer patient residing in Beaverton, Michigan smoked
marijuana medicinally in the nearby hospital where he was undergoing
chemotherapy from early 1979 until he died of his cancer in October of
that year. 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 smoked marijuana
medicinally approved, accepting marijuana's therapeutic helpfulness in
reducing nausea and vomiting.
28. In October 1979 the Michigan legislature enacted
legislation whose underlying purpose was to make marijuana available
therapeutically for cancer patients and others. The State Senate passed
the bill 29-5, the House of Representatives 100-0. In March 1982 the
Michigan legislature passed a resolution asking the Federal Congress to
try to alter Federal policies which prevent physicians from prescribing
marijuana for legitimate medical applications and prohibit its use in
medical treatments.
29. In Denver, Colorado a teenage cancer patient has been
smoking marijuana to control nausea and vomiting since 1986. He has done
this in his hospital room both before and after chemotherapy. 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
administrative personnel to handle it.
31. The child's mother read an article about marijuana smoking
helping chemotherapy patients. She obtained some marijuana from friends.
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.
They all accepted smoking marijuana as effective in controlling
chemotherapy induced nausea and vomiting. They were interested to see
the results of the cookies.
32. Soon this child was riding a tricycle in the hallways of
the Spokane hospital shortly after his chemotherapy treatments while
other children there were still vomiting into pans, tied to 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 information about
marijuana to other parents. They approved. They never told the first
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 between their
children after chemotherapy and the first child.
Other parents asked the parents of the first child about it, were told of
the use of marijuana, tried it with their children, and saw dramatic
improvement. They accepted its effectiveness. In the words of the
mother of the first child: ". . . When your kid is riding a tricycle
while his other hospital buddies are hooked up to IV needles, their heads
hung over vomiting buckets, you 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
medicinal use of marijuana by chemotherapy patients is encouraged by the
nursing staff and some physicians.
35. In addition to the physicians mentioned in the Findings
above, mostly oncologists and other practitioners, the following doctors
and health care professionals, representing several different areas of
expertise, accept marijuana as medically useful in controlling or
reducing emesis and testified to that effect in these proceedings:
a. George Goldstein, Ph.D., psychologist, Secretary of
Health for the State of New Mexico from 1978 to 1983 and chief
administrator in the implementation of the New Mexico program utilizing
marijuana;
b. Dr. Daniel Danzak, psychiatrist and former head of the
New Mexico program utilizing marijuana;
c. Dr. Tod Mikuriya, psychiatrist and editor of
Marijuana: Medical Papers, a book presenting an historical perspective of
marijuana's medical use;
d. Dr. Norman Zinberg, general psychiatrist and Professor
of Psychiatry at Harvard Medical School since 1951;
6 Affidavit of Janet Andrews, ACT rebuttal witness, par. 98.
e. Dr. John Morgan, psychopharmacologist, Board-certified
in Internal Medicine, full Professor and Director of Pharmacology at the
City University of New York;
f. Dr. Phillip Jobe, neuropsychopharmacologist with a
practice in Illinois and former Professor of Pharmacology and Psychiatry
at the Louisiana State University School of Medicine in Shreveport,
Louisiana, from 1974 to 1984;
g. Dr. Arthur Kaufman, formerly a general practitioner in
Maryland, currently Vice-President of a private medical consulting group
involved in the evaluation of the quality of care of all the U.S.
military hospitals throughout the world, who has had extensive experience
in drug abuse treatment and rehabilitation programs;
h. Dr. J. Thomas Ungerleider, a full Professor of
Psychiatry at the University of California in Los Angeles with extensive
experience in research on the medical use of drugs;
i. Dr. Andrew Weil, ethnopharmacologist, Associate
Director of Social Perspectives in Medicine at the College of Medicine at
the University of Arizona, with extensive research on medicinal plants;
and
j. Dr. Lester Grinspoon, a practicing psychiatrist and
Associate Professor at Harvard Medical School.
36. Certain law enforcement authorities have been outspoken in
their acceptance of marijuana as an antiemetic agent. Robert T. Stephan,
Attorney General of the State of Kansas, and himself a former cancer
patient, said of chemotherapy in his affidavit in this record: "The
treatment becomes a terror." His cancer is now in remission. He came to
know a number of health care professionals whose medical judgment he
respected. They had accepted marijuana
as having medical use in treatment. He was elected Vice President of the
National Association of Attorneys General (NAAG) in 1983. He was
instrumental in the adoption by that body in June 1983 of a resolution
acknowledging the efficacy of marijuana for cancer and glaucoma patients.
The resolution expressed the support of NAAG for legislation then pending
in the Congress to make 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, issued a
statement emphasizing that the proposed rescheduling of marijuana would
in no way affect or impede existing efforts by law enforcement
authorities to crack down on illegal drug trafficking.
37. At least one court has accepted marijuana as having 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
the degree of public acceptance of marijuana as effective in treating
cancer and glaucoma patients. A poll in Nebraska brought slightly over
1,000 responses - 83% favored making marijuana available by prescription,
12% were opposed, 5% were undecided. A poll in Pennsylvania elicited
1,008 responses - 83.1% favored availability by prescription, 12.2% were
opposed, 4.7% were undecided. These two surveys were conducted by professional polling companies. The Detroit Free Press conducted a telephone poll in which 85.4% of those responding favored access to marijuana by prescription. In the State of Washington the State Medical Association conducted a poll in which 80% of the doctors belonging to the Association favored controlled availability of marijuana for medical purposes.
Discussion
From the foregoing uncontroverted facts it is clear beyond any question that many people find marijuana to have, in the words of the Act, an "accepted medical use in treatment in the United States" in effecting relief for cancer patients. Oncologists, physicians treating cancer patients, accept this. Other medical practitioners and researchers accept this. Medical faculty professors accept it. Nurses performing hands-on patient care accept it.
Patients accept it. As counsel for CCA perceptively pointed out at
oral argument, acceptance by the patient is of vital importance. Doctors
accept a therapeutic agent or process only if it "works" for the patient.
If the patient does not accept, the doctor cannot administer the treatment. The patient's informed consent is vital. The doctor ascertains the patient's acceptance by observing and listening to the patient. Acceptance by the doctor depends on what he sees in the patient and hears from the patient. Unquestionably, patients in large numbers have accepted marijuana as useful in treating their emesis. 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
attorneys- general, officials whose primary concern is law enforcement. A large number of them have no fear that placing marijuana in Schedule II, thus
making it available for legitimate therapy, will in any way impede
existing efforts of law enforcement authorities to crack down on illegal
drug trafficking.
The Act does not specify by whom a drug or substance must be "accepted [for] medical use in treatment" in order to meet the Act's "accepted" requirement for placement in Schedule II. Department of Justice witnesses told the Congress during hearings in 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 vote.
In determining whether a medical procedure utilized by a doctor is
actionable 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
H.R. 13743 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
Appeals was dealing with a claim of medical malpractice resulting from a
surgical procedure claimed to have been unnecessary. The court quoted
from an Arizona court decision holding that
a method of treatment, as espoused and used by . . . a
respectable minority of physicians in the United States,
cannot be said to be an inappropriate method of 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 profession generally.
Ibid. at 294. Noting that the Federal District court in the Arizona case
found a "respectable minority" composed of sixty-five physicians
throughout the United States, the Texas court adopted as "the better
rule" to apply in its case, that
a physician is not guilty of malpractice where the
method of treatment used is supported by a respect-
able minority of physicians.
Ibid.
In Chumbler v. McClure, 505 F.2d 489 (6th Cir. 1974) the Federal
courts were dealing with a medical malpractice case under their diversity
jurisdiction, applying Tennessee law, The Court of Appeals said:
. . . The most favorable interpretation that may be placed on the testimony adduced at trial below is that there is a division of opinion in the medical profession regarding the use of Premarin in the Treatment of cerebral vascular insufficiency, and that Dr. McClure was alone among neurosurgeons in Nashville in using such therapy. The test for malpractice and for community standards is not to be determined solely by a plebiscite. Where two or more schools of thought exist among competent members of the medical profession concerning proper medical treatment for a given ailment, each of which is supported by responsible medical authority, it is not malpractice to be among the minority in a given city who follow: one of the accepted schools.
505 F.2d at 492 (Emphasis added). See, also, Leech v. Bralliar, 275
F.Supp. 897 (D.Ariz., 1967).
How do we ascertain whether there exists a school of thought
supported by responsible medical authority, and thus "accepted"? We
listen to the physicians.
The court and jury must have a standard measure
which they are to use in measuring the acts of a
doctor to determine whether he exercised a reasonable
degree of care and skill; they are not permitted to
set up and use any arbitrary or artificial standard
of measurement that the jury may wish to apply. The
proper standard of measurement is to be established
by testimony of physicians, for it is a medical
question.
Hayes v. Brown, 133 S.E. 2d. 102 (Ga., 1963) at 105.
As noted above, there is no question but that this record shows a
great many physicians, and others, to have "accepted" marijuana as having
a medical use in the treatment of cancer patients' emesis. True, all
physicians have not "accepted" it. But to require universal, 100%
acceptance would be unreasonable. Acceptance by "a respectable minority"
of physicians is all that can reasonably be required. The record here
establishes conclusively that at least "a respectable minority" of
physicians has "accepted" marijuana as having a "medical use in treatment
in the United states." That others may not makes no difference.
The administrative law judge recommended this same approach for
determining whether a drug has an "accepted medical use in treatment" in
The Matter Of MDMA Scheduling, Docket No. 84-48. The Administrator, in
his first 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
the Administrator 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
scheduling of 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]
9 Ibid., at 36558.
10 Grinspoon v. Drug Enforcement Administration, 828 F.2d 881 (1st.
Cir., 1987).
11 53 Fed. Reg. 5156 (1988). A second final rule had been issued on
January 20, 1988. It merely removed 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.
12 In neither the first nor the third final rule in the MDMA case does
the Administrator 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
representatives were mistaken or to explain why he now has abandoned
their interpretation. They wrote that language into the original
bill.
That third final rule dealing with MDMA is dealing with a synthetic,
"simple", "single-action" drug. What might be appropriate criteria for a
"simple" drug like MDMA may not be appropriate for a "complex" substance
with a number of active components. The criteria applied to MDMA, a
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
Administrator that he should not treat the absence of FDA interstate
marketing approval as conclusive evidence of lack of currently accepted
medical use. The court did not forbid the Administrator from considering
the absence of FDA approval as a factor when determining the existence of
accepted medical use. Yet on remand, in his third final order, the
Administrator adopted by reference 18 of the numbered findings he had
made in the first final order. Each of these findings had to do with
requirements imposed by FDA for approval of a new drug application (NDA)
or of an investigational new drug exemption (IND). These requirements
deal with data resulting from controlled studies and scientifically
conducted investigations and test.
Among those findings incorporated into the third final MDMA order
from the first, and relied on by the Administrator, was the determination
and recommendation of the FDA that the drug there in question was not
"accepted". In relying on the FDA's action the Administrator apparently
overlooked the fact that the FDA clearly stated that it was interpreting
"accepted medical use" in the Act as being equivalent to receiving FDA
approval for lawful marketing under the FDCA. Thus the Administrator
accepted as a basis for his 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
findings. Again, the central concern in these findings was the content
of test results and the sufficiency or adequacy of studies and scientific
reports. A careful reading of the criteria considered in the 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
tell doctors whether they should or should not accept a drug or substance
for medical use. The statute directs the Administrator merely to
ascertain whether, in fact, doctors have done so.
The MDMA third final order mistakenly looks to FDA criteria for
guidance in choosing criteria for DEA to apply. Under the Food, Drug and
Cosmetic Act the FDA is deciding - properly, under that statute - whether
a new drug should be introduced into interstate commerce. Thus it is
appropriate for the FDA to rely heavily on test results and scientific
inquiry to ascertain whether a drug is effective and whether it is safe.
The FDA must look at a drug and pass 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?"
In the MDMA third final order DEA is actually making the decision
that doctors have to make, rather than trying to ascertain the decision
which doctors have made. Consciously or not, the Agency is undertaking
to tell doctors what they should or should not accept. In so doing the
Agency is acting beyond the authority granted in the Act.
It is entirely proper for the Administrator to consider the
pharmacology of a drug and scientific test results in connection with
determining abuse potential. But abuse potential is not in issue in this
marijuana proceeding.
There is another reason why DEA should not be guided by FDA criteria
in ascertaining whether or not marijuana has an accepted medical use in
treatment. These criteria are applied by FDA pursuant to Section 505 of
the Federal Food, Drug and Cosmetic Act (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
today "new drugs" are developed by pharmaceutical companies possessing
resources sufficient to bear the enormous expense of testing a new drug,
obtaining FDA approval of its efficacy and safety, and marketing it
successfully. No company undertakes the investment required unless it
has a patent on the drug, so it can recoup its development costs and make
a profit. At oral argument Government counsel conceded that "the FDA
system is constructed for pharmaceutical companies. I won't deny that." [footnote 15]
13 21 U.S.C. § 355.
14 Alice M. O'Leary, direct, par. 9.
Since the substance being considered in this case is a natural plant
rather than a synthetic drug, it is unreasonable to make FDA-type
criteria determinative of the issue in this case, particularly so when
such criteria are irrelevant to the question posed by the act: does the
substance have an accepted medical use in treatment?
Finally, the Agency in this proceeding relies in part on the FDA's
recommendation that the Administrator 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
establishes 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.
VI.
ACCEPTED MEDICAL USE IN TREATMENT
GLAUCOMA
Findings of Fact
The preponderance of the evidence establishes the following facts
with respect to the accepted medical use of marijuana in the treatment of
glaucoma.
1. Glaucoma is a disease of the eye characterized by the
excessive accumulation of fluid causing increased intraocular pressure,
distorted vision and, ultimately, blindness. In its early stages this
pressure can sometimes be relieved by the administration of drugs. When
such medical treatment fails adequately to reduce the intraocular
pressure (IOP), surgery is generally resorted to. Although useful in
many cases, there is a high incidence of failure with some types of
surgery. Further, serious complications can occur as a result of
invasive surgery. Newer, non-invasive procedures such as laser
trabeculoplasty are thought by some to offer much greater efficacy with
fewer complications. Unless the IOP is relieved and brought to a
satisfactory level by one means or another, the patient will go blind.
2. Two highly qualified and experienced ophthalmologists in
the United States have accepted marijuana as having a medical use in
treatment for glaucoma. They are John C. Merritt, M.D. and Richard D.
North, M.D. Each of them is both a clinician, treating patients, and a
researcher. Dr. Merritt is also a professor of ophthalmology. Dr. North
has served as a medical officer in ophthalmology for the Department of
Health, Education and Welfare and has worked with the Public Health
Service and FDA.
3. Dr. Merritt's experience with glaucoma patients using
marijuana medicinally includes one Robert Randall and, insofar as the
evidence here establishes per petitioners' briefs, an unspecified number
of other patients, something in excess of 40.
4. Dr. North has treated only one glaucoma patient using
marijuana medicinally - the same Robert Randall mentioned immediately
above. Dr. North had monitored Mr. Randall's medicinal use of marijuana
for nine years as of May 1987
5. Dr. Merritt has accepted marijuana as having an im portant
place in the treatment of "End Stage" glaucoma. "End Stage" glaucoma,
essentially, defines a patient who has already lost substantial amounts
of vision; available glaucoma control drugs are no longer able adequately
to reduce the intraocular pressure (IOP) to prevent further, progressive
sight loss; the patient, lacking additional IOP reductions, will go blind.
6. Robert S. Hepler, M.D., is a highly qualified and
experienced ophthalmologist. He has done research with respect to the
effect of smoking marijuana on glaucoma. In December 1975 he prescribed
marijuana for the same Robert Randall mentioned above as a research
subject. Dr. Hepler found that large dosages of smoked marijuana
effectively reduced Robert Randall's IOP into the safe range over an
entire test day. He concluded that the only known alternative to
preserve Randall's sight which would avoid the significant risks of
surgery is to include marijuana as part of Randall's prescribed medical
regimen. He further concluded in 1977 that, if marijuana could have been
legally prescribed, he would have prescribed it for Randall as part of
Randall's regular glaucoma maintenance program had he been Randall's
personal physician.
Nonetheless, in 1987 Dr. Hepler was of the opinion that marijuana did
not have a currently accepted medical use in the United States for the
treatment of glaucoma.
7. Four glaucoma patients testified in these proceedings.
Each has found marijuana to be of help in controlling IOP.
8. In 1984 the treatment of glaucoma with Cannabis was the
subject of an Ophthalmology Grand Rounds at the University of California,
San Francisco. A questionnaire was distributed which queried the
ophthalmologists on cannabis therapy for glaucoma patients refractory to
standard treatment. 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 treatment.
9. In about 1978 an unspecified number of persons in the
public health service sector in New Mexico, including some physicians,
accepted marijuana as having medical use in treating glaucoma.
10. A majority of an unspecified number of ophthalmologists
known to Arthur Kaufman, M.D., who was formerly in general practice but
now is employed as a medical program administrator, accept marijuana as
having medical use in treatment of glaucoma.
11. In addition to the physicians identified and referred to in
the findings above, the testimony of patients in this record establishes
that no more than three or four other physicians consider marijuana to be
medically useful in the treatment of glaucoma in the United States. One
of those Physicians actually wrote a prescription for marijuana for a
patient, which, of course, she was unable to have filled.
12. There are test results showing that smoking marijuana has
reduced the IOP in some glaucoma patients. There is continuing research
underway in the United States as to the therapeutic effect of marijuana
on glaucoma.
Discussion
Petitioners' briefs fail to show that the preponderance of the
evidence in the record with respect to marijuana and glaucoma establishes
that a respectable minority of physicians accepts marijuana as being
useful in the treatment of glaucoma in the United States.
This conclusion is not to be taken in any way as criticism of the
opinions of the ophthalmologists who testified that they accept marijuana
for this purpose. The failure lies with petitioners. In their briefs
they do not point out hard, specific evidence in this record sufficient
to establish that a respectable minority of physicians has accepted their
position.
There is a great volume of evidence here, and much discussion in the
briefs, about the protracted case of Robert Randall. But when all is
said and done, his experience presents but one case. The record contains
sworn testimony of three ophthalmologists who have treated Mr. Randall.
One of them tells us of a relatively small number of other glaucoma
patients whom he has treated with marijuana and whom he knows to have
responded favorably. Another of these three doctors has successfully
treated only Randall with marijuana. The third testifies, despite his
successful experience in treating Randall, that marijuana does not have
an accepted use in such treatment.
In addition to Robert Randall, Petitioners point to the testimony of
three other glaucoma patients. Their case histories are impressive, but
they contribute
little to the carrying of Petitioner's burden of showing that marijuana
is accepted for medical treatment of glaucoma by a respectable minority
of physicians. See pages 26-29, above.
Petitioners have in evidence copies of a number of newspaper
clippings reporting 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 extra-judicial statements,
neither tested by informed inquiry nor supported by a doctor's opinion,
are not entitled to much weight. They are of little, if any,
materiality.
Beyond the evidence referred to above there is 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
a group of San Francisco ophthalmologists is ambiguous, at best. The
relevant document establishes merely that most of the doctors on the
grand round, who responded to an inquiry, believed that the THC capsules
or marijuana ought to be available.
In sum, the evidence here tending to show that marijuana is accepted
for treatment of glaucoma falls far, far short of quantum of evidence
tending to show that marijuana is accepted for treatment of emesis in
cancer patients. The preponderance of the evidence here, identified by
petitioners in their briefs, does not establish that a respectable
minority of physicians has accepted marijuana for glaucoma treatment.
VII.
ACCEPTED MEDICAL USE IN TREATMENT
MULTIPLE SCLEROSIS, SPASTICITY
AND HYPERPARATHYROIDISM
Findings Of Fact
The preponderance of the evidence clearly establishes the following
facts with respect to marijuana's use in connection with multiple
sclerosis, spasticity and hyperparathyroidism.
1. Multiple sclerosis is the major cause of neurological
disability among young and middle-aged adults in the United States today.
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 initial stages
of the disease nerve impulses are transmitted with only minor interruptions. As the disease progresses, the plaques may completely obstruct the impulses along certain nerve systems. These 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
and abnormal contraction of muscle or muscle fibers. (Spasticity can
also result from serious injuries to the spinal cord, not related to
multiple sclerosis.)
3. The symptoms of multiple sclerosis vary according to the
area of the nervous system which is affected and according to the severity of the disease. The symptoms can include one or more of the following:
weakness, tingling, numbness, impaired sensation, lack of coordination,
disturbances in equilibrium, double vision, loss of vision, involuntary
rapid movement of the eyes (nystagmus), slurred speech, tremors,
stiffness, spasticity, weakness of limbs, sexual dysfunction, paralysis,
and impaired bladder and bowel functions.
4. Each person afflicted by multiple sclerosis is affected
differently. In some persons, the symptoms of the disease are barely
detectable, even over long periods of time. In these cases, the persons
can live their lives as if they did not suffer from the disease. In
others, more of the symptoms are present and acute, thereby limiting
their physical capabilities. Moreover, others may experience sporadic,
but acute, symptoms.
5. At this time, there is no known prevention or cure for
multiple sclerosis. 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
the specific indication of spasticity. These drugs are Dantrium and
Lioresal baclofen.
6. Unfortunately, neither Dantrium nor Lioresal is a very
effective spasm control drug. Their marginal medical utility, high
toxicity and potential for serious adverse effects make these drugs
difficult to use in spasticity therapy.
7. As a result, many physicians routinely prescribe
tranquilizers, muscle relaxants, mood elevators and sedatives such as
Valium to patients experiencing spasticity. While these drugs do not
directly reduce spasticity they may weaken the patient's muscle tone, thus making the spasms less noticeable. Alternatively, they may induce sleep or so tranquilize the patient that normal mental and physical functions are impossible.
8. A healthy, athletic young woman named Valerie Cover was
stricken with multiple sclerosis while in her early twenties. She
consulted several medical specialists and followed all the customary
regimens and prescribed methods for coping with this debilitating disease
over a period of several years. None of these proved availing. Two
years after first experiencing the symptoms of multiple sclerosis her
active, productive life - as an athlete, Navy officer's wife and mother -
was effectively over. The Social Security Administration declared her
totally disabled. To move about her home she had to sit on a skateboard
and push herself around. She spent most of her time in bed or sitting in
a wheelchair.
9. An occasional marijuana smoker in her teens, before her
marriage, she had not smoked it for five years as of February 1986. Then
a neighbor suggested that marijuana just might help Mrs. Cover's multiple
sclerosis, having read that it had helped cancer patient's control their
emesis. Mrs. Cover acceded to the suggestion.
10. Just before smoking the marijuana cigarette produced by her
neighbor, Mrs. Cover had been throwing up and suffering from spasms.
Within five minutes of smoking part of the marijuana cigarette she
stopped vomiting, no longer felt nauseous and noticed that the intensity
of her spasms was significantly reduced. She stood up unaided.
11. Mrs. Cover began smoking marijuana whenever she felt
nauseated. When she did so it controlled her vomiting, stopped the
nausea and increased her 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
jeopardize the career of her Navy officer husband, Mrs. Cover stopped
smoking marijuana several times. Each time she did so, after about a
month, she had retrogressed to the point that her multiple sclerosis
again had her confined to bed and wheelchair or skateboard. As of the
Spring of 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
first exhibited symptoms of multiple sclerosis at age 19 and it was
diagnosed at that time. Her condition has grown progressively worse.
She has been under the care of physicians and hospitalized for treatment.
Many drugs have been prescribed for her by her doctors. At one point in
1983 she listed the drugs that had been prescribed for her. There were 17 on the list. None of them has given her the relief from her multiple sclerosis symptoms that marijuana has.
15. During the early stages in the development of her illness
Ms. Hirsch found that smoking marijuana improved the quality of her life,
keeping her spasms under control. Her balance improved. She seldom
needed to use her cane for support. Her condition lately has deteriorated. As of May 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,
the attendant, treats a number of patients who smoke marijuana for relief
of multiple sclerosis symptoms. In about 1980 another patient told Ms.
Hirsch that he knew many patients who smoke marijuana to relieve their
spasms. Through him she met other patients and found that marijuana was
commonly used by many multiple sclerosis patients. Most of these persons
had told their doctors about their doing so. None of those doctors
advised against the practice and some encouraged it.
17. Among the drugs prescribed by doctors for Ms. Hirsch was
ACTH. This failed to give her any therapeutic benefit or to control her
spasticity. It did produce a number of adverse effects, including severe
nausea and vomiting which, in turn, were partly controlled by rectally
administered anti-emetic drugs.
18. Another drug prescribed for her was Lioresal, intended to
reduce her 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.
There was 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
Prudential Insurance 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
prescribe it 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 eventually substituted.
22. One day Paufler became semi-catatonic while sitting in his
living room at home. He was rushed to the hospital emergency room. He
nearly died. Lab reports indicated, among other things, a nearly total
lack of potassium in his body. He was given massive injections of
potassium in the emergency room and placed on an oral supplement.
Paufler resolved to take no more steroids.
23. From time to time, prior to this point, Paufler had smoked
marijuana socially with visiting friends, seek some relief from his
misery in a temporary "high". He now began smoking marijuana more often.
After some weeks he found that he could stand and then walk a bit. His
doctor dismissed the idea that marijuana could be helpful with multiple
sclerosis, and Paufler, himself, was skeptical at first. He began
discontinuing it for a while, then resuming.
24. Paufler found that when he did not smoke marijuana his
condition worsened, he suffered more intense spasms more frequently.
When he smoked marijuana, his condition would stabilize and then improve;
spasms were more controlled and less severe; he felt better; he regained
control over his limbs and could walk totally unaided. His vision, often
blurred and unfocused, improved. Eventually he began smoking marijuana
on a daily basis. He ventured outdoors. He was soon walking half a
block. His eyesight returned to normal.
His central field blindness cleared up. He could focus well enough to
read again. One evening he went out with his children and found he could
kick a soccer ball again.
25. Paufler has smoked marijuana regularly since 1980. 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
necessity" in court when charged with using or possessing marijuana. He
learned that doctors, researchers and other multiple sclerosis patients
had supported Diana's position in the court proceeding.
27. Irwin Rosenfeld has been diagnosed as having Pseudo Pseudo
Hypoparathyroidism. 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
causes enormous 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.
Various drugs were prescribed for him for pain relief. He was taking
extremely powerful 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
relaxants.
30. At college in Florida Rosenfeld was introduced to marijuana
by classmates. He experimented with it recreationally. He never
experienced a "high" or "buzz" or "floating sensation" from it. One day
he smoked marijuana while playing chess with a friend. It had been very
difficult for him to sit for more than five or ten minutes at a time
because of tumors in the backs of his legs. Suddenly he realized that,
absorbed in his chess game, and smoking 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.
Something
certainly was - there was a drastic decrease in Rosenfeld's need for such
drugs as Dilaudid and Demerol and for sleeping pills. The quality of
pain relief which followed his smoking of marijuana was superior to any
he had experienced before. As his dosages of powerful conventional drugs
decreased, Rosenfeld became less withdrawn from the world, more able to
interact and function. So he has continued to the present time.
32. After some time Rosenfeld's doctor accepted the fact that
the marijuana was therapeutically helpful to Rosenfeld and submitted an
IND application to FDA to obtain supplies of it legally for Rosenfeld.
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 support of
legislation to make marijuana available for therapeutic purposes in that
State.
33. In 1969, at age 19, David Branstetter dove into the shallow
end of a swimming pool and broke his neck. He became a quadriplegic,
losing control 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 of long-term
addiction. His spasms then became uncontrollable, often becoming so bad
they would throw him from his wheelchair.
34. In about 1973 Branstetter began smoking marijuana
recreationally. He discovered that his severe spasms stopped whenever he
smoked marijuana.
Unlike Valium, which only masked his symptoms and caused him to feel
drunk and out of control, marijuana brought his spasmodic condition under
control without impairing his faculties. When he was smoking marijuana
regularly he was more active, alert and outgoing.
35. Marijuana controlled his spasms so well that Branstetter
could go out with friends and he began to play billiards again. The
longer he smoked marijuana the more he was able to use his arms and
hands. Marijuana also improved his bladder control and bowel movements.
36. At times the illegal marijuana Branstetter was smoking
became very expensive and sometimes was unavailable. During periods when
he did not have marijuana his spasms would return, preventing Branstetter
from living a "normal" life. He would begin to shake uncontrollably, his
body would feel tense, and his muscles would spasm.
37. 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
marijuana while several, directly and indirectly, have encouraged him to
continue. Branstetter knows of almost 20 other patients, paraplegics,
quadriplegics and multiple sclerosis sufferers, who smoke marijuana to
control their spasticity.
40. In 1981 a State of Washington Superior Court judge, sitting
without a jury, found Samuel D. Diana not guilty of the charge of
unlawful possession of marijuana. In so doing the judge upheld Diana's
defense of medical necessity. Diana had been a multiple sclerosis
patient since at least 1973. He testified that smoking marijuana
relieved his symptoms of double vision, tremors, unsteady walk, impaired
hearing, tendency to vomit in the mornings and stiffness in the joints of
his hands and legs.
41. Among the witnesses was a physician who had examined
defendant Diana before and after he had used marijuana. This doctor
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 sclerosis who
testified in detail as to marijuana's beneficial effect on their illness.
42. In acquitting defendant Diana of unlawful possession of
marijuana the trial judge found that the three requirements for the
defense of medical necessity had been established, namely: defendant's
reasonable belief that his use of marijuana was necessary to minimize the effects of multiple sclerosis; the benefits derived from its use are greater than the harm sought to be prevented by the controlled substances law; and no drug is as effective as marijuana in minimizing the effects of the disease in the defendant.
43. Denis Petro, M.D., is a neurologist of broad experience,
ranging from active practice in neurology to teaching the subject in
medical school and employment by FDA as a medical officer reviewing IND's
and NDA's. He has also been employed by pharmaceutical companies and has
served as a consultant to the State of New York. He is well acquainted
with the case histories of three patients who have successfully utilized
marijuana to control severe spasticity when other, FDA-approved drugs
failed to do so. Dr. Petro knows of other cases of patients who, he
has determined, have effectively used marijuana to control their spasticity. He has heard reports of additional patients with multiple sclerosis, paraplegia and 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,
particularly in Veterans Hospitals, routinely smoke marijuana to reduce
spasticity. While this mode of treatment is illegal, it is generally
tolerated, if not openly encouraged, by physicians in charge of such
wards who accept this practice as being of benefit to their patients.
There are many spinal cord injury patients in Veterans Hospitals.
45. Dr. Petro sought FDA approval to conduct research with
spasticity patients using marijuana. FDA refused but, for reasons
unknown to him, allowed him to make a study using synthetic THC. He and colleagues made such a study. They concluded that synthetic THC effected a significant reduction in spasticity among multiple sclerosis patients, but study participants who had also smoked marijuana reported consistently that
marijuana was more effective.
46. Dr. Petro accepts marijuana as having a medical use in the
treatment of spasticity in the United States. If it were legally
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,
Arizona, who also teaches at the University of Arizona College of
Medicine, accepts marijuana as having a medical use in the treatment of
spasticity. In multiple sclerosis patients the muscles become tense and
rigid because their nerve supply is interrupted. Marijuana relieves this
spasticity in many patients, he has found. He would prescribe it to
selected patients if it were legally available,
49. Dr. Lester B. Collins, III, a neurologist, then treating
about 20 multiple sclerosis patients a year, seeing two or three new ones
each year, stated in 1983 that he had no doubt that marijuana worked
symptomatically for some multiple sclerosis patients. He said that it
does not alter the course of the disease but it does relieve the symptoms of spasticity.
50. Dr. John P. Morgan, board certified in internal medicine,
Professor of Medicine and Director of Pharmacology at CCNY Medical School
in New York and Associate Professor of Medicine and Pharmacology at Mt.
Sinai School of Medicine, accepts marijuana as having medical use in
treatment in the United States. If he were practicing medicine and
marijuana were legally available he would prescribe it when indicated to
patients with legitimate medical needs.
Discussion
Based upon the rationale set out in pages 26 to 34, above, the
administrative law judge concludes that, within the meaning of the Act,
21 U.S.C. § 812(b)(2)(B), marijuana "has a currently accepted medical use
in treatment in the United States" for spasticity resulting from multiple
sclerosis and other causes. It would be unreasonable, arbitrary and
capricious to find otherwise. The facts set out above, uncontroverted by
the Agency, establish beyond question that some doctors in the United
States accept marijuana as helpful in such treatment for some patients.
The record here shows that they constitute a significant minority of
physicians. Nothing more can reasonably be required. That some doctors
would have more studies and test results in hand before accepting
marijuana's usefulness here is irrelevant.
The same is true with respect to the hyperparathyroidism from which
Irvin Rosenfeld suffers. His disease is so rare, and so few physicians
appear to be familiar with it, that acceptance by one doctor of marijuana
as being useful in treating it ought to satisfy the requirement for a
significant minority. The Agency points to no evidence of record tending
to establish that marijuana is not accepted by doctors in connection with this most unusual ailment.
Refusal to acknowledge acceptance by a significant minority, in light of
the case history detailed in this record, would be unreasonable,
arbitrary and capricious.
VIII.
ACCEPTED SAFETY FOR USE UNDER MEDICAL SUPERVISION
With respect to whether or not there is "a lack of accepted safety
for use of [marijuana] under medical supervision", the record shows the
following facts to be uncontroverted.
Findings of Fact
1. Richard J. Gralla, M.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
side effects.
2. Andrew T. Weil, M.D., who now practices medicine in Tucson,
Arizona and is on the faculty of the College of Medicine, University of
Arizona, was a member of the first team of researchers to perform a
Federal Government authorized study into the effects of marijuana on
human subjects. This team made its study in 1968. These researchers
determined that marijuana could be safely used under medical supervision.
In the 20 years since then Dr. Weil has seen no information that would
cause him to reconsider that conclusion. There is no question in his
mind but that marijuana is safe for use under appropriate medical
supervision.
3. The most obvious concern when dealing with drug safety is
the possibility of lethal effects. 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
cannabis-induced fatality.
5. This is a remarkable statement. First, the record on
marijuana encompasses 5,000 years of human experience. Second, marijuana
is now used daily by enormous 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
single death.
6. By contrast aspirin, a commonly used, over-the-counter
medicine, causes 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 success. Simply
stated, researchers have been unable to give animals enough marijuana to
induce death.
8. At present it is estimated that marijuana's LD-50 is around
1:20,000 or 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
marijuana cigarettes weigh approximately .9 grams. A smoker would
theoretically have to consume nearly 1,500 pounds of marijuana within
about fifteen minutes to induce a lethal response.
9. In practical terms, marijuana cannot induce a lethal
response as a result of drug-related toxicity.
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
adverse effects.
11. A commonly used over-the-counter product like aspirin has a
therapeutic 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
recommended (therapeutic) dose.
13. There are, of course, prescriptive drugs which have much
lower therapeutic ratios. Many of the drugs used to treat patients with
cancer, glaucoma and multiple sclerosis are highly toxic. The
therapeutic ratio of 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, while being
properly employed.
14. By contrast, marijuana's therapeutic ratio, like its LD-50,
is impossible to quantify because it is so high.
15. In strict medical terms marijuana is far safer than many
foods we commonly consume. For example, eating ten raw potatoes can
result in a toxic response. By comparison, it is physically impossible
to eat enough marijuana to induce death.
16. Marijuana, in its natural form, is one of the safest
therapeutically
active substances known to man. By any measure of rational analysis
marijuana can be safely used within a supervised routine of medical care.
17. Some of the drugs most widely used in chemotherapy
treatment of cancer have adverse effects as follows:
Cisplatin, one of the most powerful 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
patient's intravenous lead slips during treatment and
this drug gets on or under the skin the patient may
suffer serious injury including temporary, and in
extreme cases, permanent, loss of use of the arm.
Procarbizine, also used for Hodgkins disease -
has known psychogenic, i.e., emotional, effects.
Cyoxin, also known as Cyclophosphanide -
suppresses patient's immune system response; results
in serious bone marrow depletion; studies indicate
this drug may also cause other cancers, including
cancers of the bladder.
Adriamycan, has numerous adverse effects; is
difficult to employ in long term therapies because it
destroys the heart muscle.
While each of these agents has its particular adverse effects, as
indicated above, they also cause a number of similar, disturbing adverse
effects. Most of these drugs cause hair loss. Studies increasingly
indicate all of these drugs may cause other forms of cancer. Death due
to kidney, heart or respiratory failure 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
patients who have smoked marijuana. These have occurred in marijuana-
naive persons, usually older persons, who are extremely anxious over the
forthcoming chemotherapy and troubled over the illegality of their having
obtained the marijuana. Such persons have responded to simple person-to-
person communication with a doctor and have sustained no long term mental
or physical damage. If marijuana could be legally obtained, and
administered in an open, medically-supervised session rather than
surreptitiously, the few instances of such adverse reaction doubtless
would be reduced in number and severity.
19. Other reported side effects of marijuana have been minimal.
Sedation 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 being employed
as an agent under medical supervision.
20. All drugs have "side effects" and all drugs used in
medicine for their therapeutic benefits have unwanted, unintended,
sometimes adverse effects.
21. In medical treatment "safety" is a relative term. A drug
deemed "safe" for use in treating a life-threatening disease might be
"unsafe" if prescribed for a patient with a minor ailment. The concept
of drug "safety" is relative. Safety is measured against the
consequences a patient would confront in the absence of therapy. The
determination 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
that glaucoma, untreated, progressively destroys the optic nerve and
results in eventual blindness. The danger, then, to patients with
glaucoma is an irretrievable loss of their sight.
23. Glaucoma is not a mortal disease, but a highly specific,
selectively incapacitating condition. Glaucoma assaults and destroys the
patient's most evolved and critical sensory ability, his or her vision.
The vast majority of patients afflicted with glaucoma are adults over the
age of thirty. The onset of blindness in middle age or later throws
patients into a 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 fully adjust
to their new, uncertain circumstances.
24. Blindness is a very grave consequence. Protecting patients
from blindness 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
practice, physicians often provide glaucoma patients with drugs which
have many serious adverse effects.
25. There are only a limited number of drugs available for the
treatment of glaucoma. All of these drugs produce adverse effects.
While several government witnesses lightly touched on the side effects of
these drugs, none provided a full or detailed description of their known
adverse consequences.
26. The adverse physical consequences resulting from the
chronic use of 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, increases and
decreases in heart rate and pulse, disruption of heart function, chronic
and acute renal disease, and bone marrow depletion.
27. Finally, each FDA-approved drug family used in glaucoma
therapy is capable of producing a lethal response, even when properly
prescribed and used. Epinephrine can lead to elevated blood pressure
which may result in stroke or heart attack. Miotic drugs suppress
respiration and can cause respiratory Paralysis. Diuretic drugs so alter
basic body chemistry they cause renal stones and may destroy the
patient's kidneys or result in death due to heart failure. Timolol and
related beta-blocking agents, the most recently approved family of
glaucoma control drugs, can trigger severe asthma attacks or cause death
due to sudden cardiac arrhythmias often producing cardiac arrest.
28. Both of the FDA-approved drugs used in treating the
symptoms of multiple sclerosis, Dantrium and Lioresal, while accepted as
"safe" can, in fact, be very dangerous substances. Dantrium or dantrolene sodium carries a boxed warning in the Physician's Desk Reference (PDR) because of its very high toxicity. Patients using this drug run a very real risk of developing sympto-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
failure.
29. The adverse effects associated with Lioresal baclofen are
somewhat less severe, but include possibly lethal consequences, even when
the drug is properly prescribed and taken as directed. The range 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
and Associate Professor of Medicine at Harvard Medical School, accepts
marijuana as safe for use under medical supervision. He believes its
safety is its greatest advantage as a medicine in appropriate cases.
32. Tod H. Mikuriya, M.D., a psychiatrist practicing in
Berkley, California who treats substance abusers as inpatients and
outpatients, accepts marijuana as safe for use under medical supervision.
33. Richard D. North, M.D., who has treated Robert Randall for
glaucoma with marijuana for nine years, accepts marijuana as safe for use
by his patient under medical supervision. Mr. Randall has smoked ten marijuana cigarettes a day during that period without any evidence of adverse
mental or physical effects from it.
34. John C. Merritt, M.D., an expert in ophthalmology, who has
treated Robert Randall and others with marijuana for glaucoma, accepts
marijuana as being safe for use in such treatment.
35. Deborah B. Goldberg, M.D., formerly a researcher in
oncology and now a practicing physician, having worked with many cancer
patients, observed them, and heard many tell of smoking marijuana
successfully to control emesis, accepts marijuana 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 under medical
supervision. (See finding 17, above.)
36. Ivan Silverberg, M.D., board certified in oncology and
practicing that 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
care professionals 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.
Discussion
The Act, at 21 U.S.C. § 812(b)(1)(C), requires that marijuana be
retained in Schedule I if "[t]here is a lack of accepted safety for use
of [it] under medical supervision." If there is no lack of such safety,
if it is accepted that this substance can be used with safety under
medical supervision, then it is unreasonable to keep it in Schedule I.
Again we must ask - "accepted" by whom? In the MDMA proceeding the
Agency's first Final Rule decided that "accepted" here meant, as in the
phrase "accepted medical use in treatment", that the FDA had accepted the
substance pursuant to the provisions of the Food, Drug and Cosmetic Act.
51 Fed. Reg. 36555 (1986). The Court of Appeals held that this was
error. On remand, in its third Final Rule on MDMA, the Agency made the
same ruling as before, relying essentially on the same findings, and on
others of similar nature, just as it did with respect to "accepted
medical use." 53 Fed. Reg. 5156 (1988).
The administrative law judge finds himself constrained not to follow
the rationale in that MDMA third Final Order for the same reasons as set
out 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
acceptance as safe is to assert that more studies, more tests are needed.
The Agency has presented highly qualified and respected experts,
researchers and others, who hold that view. But, as demonstrated in the
discussion in Section V 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 States.
Findings are made above with respect to the safety of medically
supervised use of marijuana by glaucoma patients. Those findings are
relevant to the safety issue even though the administrative law judge
does not find accepted use in treatment of glaucoma to have been shown.
Based upon the facts established in this record and set out above
one must reasonably conclude that there is accepted safety for use of
marijuana under medical supervision. To conclude otherwise, on this
record, would be unreasonable, arbitrary and capricious.
IX.
CONCLUSION
AND
RECOMMENDED DECISION
Based upon the foregoing facts and reasoning, the administrative law
judge concludes that the provisions of the Act permit and require the
transfer of marijuana from Schedule I to Schedule II. The Judge realizes
that strong emotions are 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 potential.
Transferring marijuana from Schedule I to Schedule II will not, of
course, make it immediately available in pharmacies throughout the
country for legitimate use in treatment. Other government authorities,
Federal and State, will doubtless have to act before that might occur.
But this Agency is not charged with responsibility, or given authority,
over the 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 of
other regulatory bodies are the concerns of those bodies, not of this
Agency,
There are those who, in all sincerity, argue that the transfer of
Marijuana to Schedule II will "send a signal" that marijuana is "OK" generally for recreational use. This argument is specious. It presents no valid reason for refraining from taking an action required by law in light of
the evidence. If marijuana should be placed in Schedule II, in obedience
to the law, then that is where marijuana should be placed, regardless of
misinterpretation of the placement by some. The reasons for the placement can, and should, be clearly explained at the time the action is taken. The fear of sending such a signal cannot be permitted to 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
accepted as capable of relieving the distress of great numbers of very
ill people, and doing so with safety under medical supervision. It would
be unreasonable, 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
conclude that the marijuana plant considered as a whole has a currently
accepted medical use in treatment in the United States, that there is no
lack of accepted safety for use of it under medical supervision and that
it may lawfully be transferred from Schedule I to Schedule II. The judge
recommends that the Administrator transfer marijuana from Schedule I to
Schedule II.
Dated: SEP 6 1988
Francis L. Young
Administrative Law Judge
CERTIFICATE OF SERVICE
This is to certify that the undersigned on SEP 6 1988, caused a copy
of the 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
and caused a copy to be mailed, postage paid, to each of the following:
National Organization for the Carl Eric Olsen
Reform of Marijuana Laws Post Office Box 5034
Attn: Kevin B. Zeese, Esq. Des Moines, Iowa 50306
Zwerling, Mark, Ginsberg and Lieberman, P.C.
1001 Duke Street Cannabis Corporation of
Alexandria, Virginia 22313 America
Attn: Laurence O. McKinney
National Federation of Parents President
for Drug-Free Youth c/o McKinney & Company
Attn: Karl Bernstein 881 Massachusetts Avenue
Vice President Cambridge, Massachusetts 02139
8730 Georgia Avenue
Suite 200 International Association of
Silver Spring, Maryland 20910 Chiefs of Police
Attn: Virginia Peltier, Esq.
Alliance for Cannabis Therapeutics Assistant Legal Counsel
c/o Frank B. Stillwell, III, Esq. 13 Firstfield Road
Steptoe & Johnson P.O. Box 6010
Attorneys at Law Gaithersburg, Maryland 20878
1330 Connecticut Avenue, N.W.
Washington, D.C. 20036
David C. Beck, Esq.
McDermott, Will & Emery
1850 K Street, N.W.
Washington, D.C. 20006
Attorney for Cannabis Corporation of America
Dianne L. Martin
Hearing Clerk
