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Marijuana
and Medicine
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Appendixes
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APPENDIX
A
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Workshop
Agendas
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APPENDIX
B
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Scheduling
Definitions
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APPENDIX
C
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Statement
of Task
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APPENDIX
D
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Recommendations
made in Recent Reports on the Medical Use of Marijuana
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APPENDIX
E
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Rescheduling
Criteria
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APPENDIX A
Workshop Agendas
INSTITUTE OF MEDICINE
NATIONAL ACADEMY OF SCIENCES
Division of Neuroscience and Behavioral Health
Medical Used of Marijuana: Assessment of the Science Base
Workshop on
Perspective on the Medical Use of Marijuana: Basic and Clinical Science
December 14-16, 1997
Beckman Center, Irvine, California
WORKSHOP AGENDA
Sunday, December 14, 1997
2:00 Introduction
Constance Pechura, IOM Division Director, Neuroscience and
Behavioral Health
2:30 Public input session, 5 minutes per person
Moderator, Stanley Watson, Jr., IOM Study Investigator
University of Michigan
5:30 ADJOURN
Monday, December 15, 1997
Cannabinoid Neuroscience
8:30 Moderator
Stanley Watson, IOM Study Investigator University of Michigan
8:45 Neuropharmacology of Cannabinoids and Their Receptors
Steven R. Childers, Wake Forest University School of Medicine
9:15 Precipitated Cannabinoid Withdrawal and Sensory Processing
of Painful Stimuli J. Michael Walker, Brown University
9:45 Role of Cannabinoids in Movement Clara Sanudo, Brown University
10:15 Tolerance and Cannabinoid-Opioid Interactions Sandra P. Welch, Medical
College of Virginia
10:45 BREAK
Medical Uses of Marijuana: Clinical Data and Basic Biology
11:10 John A. Benson, Jr., IOM Study Investigator
Oregon Health Sciences University
11:15 Profile of Medical Marijuana Users
John Mendelson, University of California at San Francisco
11:45 Immune Modulation by Cannabinoids
Norbert KaminskI, Michigan State University
12:15 Psychological Effects of Marijuana Use
Charles R. Schuster, Wayne State University
12:45 LUNCH
1:45 Marijuana and Glaucoma
Paul Kaufman, University of Wisconsin
2:15 Effects of Marijuana and Cannabinoids in Neurological Disorders
Paul Consroe, University of Arizona Health Sciences Center
2:45 Neural Mechanisms of Cannabinoid Analgesia
Howard Fields, University of California at San Francisco
3:15 Pain Management.
Michael Rowbotham, University of California at San Francisco
3:45 Wasting Syndrome Pathogenesis and Clinical Markers
Donald Kotler, St. Lukes'-Roosevelt Hospital
4:15 Clinical Experience with Marijuana
Stephen O'Brien, East Bay AIDS Center
4:45 ADJOURN
Tuesday. December 16, 1997
Medical Uses of Marijuana: Clinical Data and Basic Biology
8:30 Moderator
John A. Benson, Jr., IOM Study Investigator
Oregon Health Sciences University
8:45 Marijuana in AIDS Wasting: Tribulations and Trials
Donald I. Abrams, University of California at San Francisco
9:l5 Nausea and Vomiting: Underlying Mechanisms and Upcoming Treatments
Alan D. Miller, The Rockefeller University
9:45 Post-chemotherapy Nausea and Anti-emetics
Richard J. Gralla, Ochsner Cancer Center
10:15 BREAK
Summary Views
10:30 Marijuana is Different from THC: A Review of Basic Research
and State Studies of Anti-emesis
Richard E. Musty, University of Vermont
11:00 Medical Uses of Crude Marijuana: Medical and Social Issues
Eric A. Voth, The International Drug Strategy Institute
11:30 General Questions
Moderator, John A. Benson, Jr., IOM Study Investigator
12:00 ADJOURN
INSTITUTE OF MEDICINE
NATIONAL ACADEMY OF SCIENCES
Division of Neuroscience and Behavioral Health
Medical Use of Marijuana: Assessment of the Science Base
Workshop on
Acute and Chronic Effects of Marijuana Use
January 22-23, 1998
New Orleans Marriott Hotel
New Orleans, LA
WORKSHOP AGENDA
Thursday, January 22, 1998
2:00 Introduction
Constance Pechura, IOM Division Director
Neuroscience and Behavioral Health
2:30 Public Input Session, 5 minutes per person
Moderator, Stanley Watson, Jr, IOM Study Investigator
University of Michigan
4:30 ADJOURN
Friday. January 23. 1998
8:30 Moderator
John A. Benson, Jr., IOM Study Investigator
Oregon Health Sciences University
Health Consequences of Marijuana Use
9:00 Health Consequences of Marijuana Use: Epidemiologic Studies
Stephen Sidney, Kaiser Permanente, Oakland, CA
9:30 Immunity, Infections, and Cannabinoids
Thomas Klein, University of South Florida
10:00 Pulmonary Effects of Smoked Marijuana
Donald Tashkin, Unversity of California at Los Angeles
10:30 BREAK
Tuesday, December 16, 1997
Medical Uses of Marijuana: Clinical Data and Basic Biology
8:30 Moderator
John A. Benson, Jr., IOM Study Investigator
Oregon Health Sciences University
8:45 Marijuana in AIDS Wasting: Tribulations and Trials
VC Donald I. Abrams, University of California at San Francisco
9.15 Nausea and Vomiting: Underlying Mechanisms and Upcoming Treatments
Alan D. Miller, The Rockefeller University
9:45 Post-chemotherapy Nausea and Anti-emetics
Richard J. Gralla, Ochsner Cancer Center
10:15 BREAK
Summary Views
10:30 Marijuana is Different from THC: A Review of Basic Research
and State Studies of Anti-emesis
Richard E. Musty, University of Vermont
11:00 Medical Uses of Crude Marijuana: Medical and Social Issues
Eric A. Voth, The International Drug Strategy Institute
11:30 General Questions
Moderator, John A. Benson, Jr., IOM Study Investigator
12:00 ADJOURN
10-45 Is Marijuana Carcinogenic?
Epidemiological evidence for and against biological evidence for and against
Panel Discussion
Stephen Sidney
Donald Tashkin
12:00 LUNCH
Effects of Marijuana on Behavior
1:30 Marijuana: Addictive and Amotivational States, the Scientific Evidence
John Morgan, City University of New York Medical School
2:00 Marijuana's Acute Behavioral Effects in Humans
Richard Foltin' Columbia University
2:30 Tolerance and Dependence Following Chronic
Administration of oral THC or smoked marijuana to humans
Margaret Haney, Columbia University
3:00 Patterns of Continuity and Discontinuity of Marijuana Use in
Relationship to Other Drugs
Robert Pandina, Rutgers University
3:30 ADJOURN
INSTITUTE OF MEDICINE
NATIONAL ACADEMY OF SCIENCES
Division of Neuroscience and Behavioral Health
Medical Use of Marijuana: Assessment of the Science Base
Workshop on
Prospects for Cannabinoid Drug Development
February 23-24, 1998
National Academy of Sciences Building
Washington, D.C.
WORKSHOP AGENDA
Monday. FEBRUARY 23 , 1998
1:30 Introduction
CONSTANCE PECHURA, IOM Division Director
Neuroscience and Behavioral Health
2:00 Public Input Session, 5 minutes per person
Moderator: JoHN A. BENSON, JR., IOM Study Investigator
Oregon Health Sciences University
5:30 ADJOURN
TUESDAY. FEBRUARY 24. 1998
8:30 Introduction
CONSTANCE PECHURA, IOM Division Director
Neuroscience and Behavioral Health
Moderator: STANLEY J. WATSON, Jr., IOM Study Investigator
University of Michigan
Overviews of Preceding Workshops
8:45 Acute and Chronic Effects of Marijuana
BILLY R. MARTIN, Medical College of Virginia
9:25 Perspectives on the Medical Use of Marijuana
ERIC B. LARSON, University of Washington Medical School
9:55 The Neurobiology of Cannabinoid Dependence
GEORGE F. Koob, Scripps Research Institute
10:25 BREAK
TUESDAY. FEBRUARY 24, 1998
Drug Development
10:45 Regulatory Requirements Affecting Marijuana
J. RICHARD CROUT, Crout Consulting
11:15 Marinol and the Market
Robert E. DUDLEY, Unimed Pharmaceuticals, Inc.
l1:45 Development of Cannabis-based Therapeutics
DAVE PATE, HortaPharm, B.V.
12:15 LUNCH
Drug Delivery
1:30 Alternative Drug Delivery Technologies for the Therapeutic Use of
Marijuana
PHYLLIS I. GARDNER, ALZA Corporation, Stanford University
2:00 Delivery of Analgesics via the Respiratory Track
REID M. RUBSAMEN, Aradigm Corporation
2:30 Current Concepts for Delivery of THC
MAHENDRA G. DEDHIYA, Roxanne Laboratories, Inc.
3:00 D9-THC-Hemisuccinate in Suppository Formulation: An Alternative to
Oral and Smoked THC
MAHMOUD A. ELSOHLY, University of Mississippi,
ElSohly Laboratories, Inc.
3:30 Concluding Remarks
JOHN A. BENSON, JR., IOM Study Investigator
Oregon Health Sciences University
3:45 ADJOURN
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APPENDIX AA
Individuals and Organizations that Spoke or
Wrote to the Institute of Medicine
A complete list will appear in the published report
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APPENDIX B
Scheduling Definitions
Scheduling Definitions Established by the Controlled Substances Act of
1970
Schedule I (includes heroin, LSD, and marijuana)
(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 the use of the drug or
other substance under medical supervision.
Schedule II (includes Marinol¨ methadone, morphine, methamphetamine, and
cocaine)
(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 may lead to severe
psychological or physical dependence.
Schedule III (includes anabolic steroids)
(A) The drug or other substance has a potential of abuse less than
the drugs or other substances in schedules I and II.
(B) The drug or other substance has a currently accepted medical
use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to moderate or
low physical dependence or high psychological dependence.
Schedule IV (includes Valium(R) and other tranquilizers)
(A) The drug or other substance has a low potential for abuse
relative to the drugs or other substances in Schedule III.
(B) The drug or other substance has a currently accepted medical
use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to limited
physical dependence or psychological dependence relative to the
drugs or other substances in schedule III.
Schedule V (includes codeine-containing analgesics)
(A) The drug or other substance has a low potential for abuse
relative to the drugs or other substances in schedule IV.
(B) The drug or other substance has a currently accepted medical
use in treatment in the United States.
(C) Abuse of the drug or other substance may lead to limited
physical dependence or psychological dependence relative to the
drugs or other substances in schedule IV.
Sources: LeCraw (1996) and 21 U.S.C. 812.
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APPENDIX C
Statement of Task
The study will assess what is currently known, and not known about the
medical use of marijuana. It will include a review of the science base
regarding the mechanism of action of marijuana, an examination of the
peer-reviewed scientific literature on the efficacy uses of marijuana,
and
the costs of using various forms of marijuana versus approved drugs for
specific medical conditions (e.g., glaucoma, multiple sclerosis, wasting
diseases, nausea, and pain).
The study will also include an evaluation of the acute and chronic
effects of marijuana on health and behavior; a consideration of the adverse
effects of marijuana use compared with approved drugs; an evaluation of
the
efficacy of different delivery systems for marijuana (e.g., inhalation
vs.
oral); and an analysis of the data concerning marijuana as a gateway drug,
and an examination of the possible differences in the effects of marijuana
due to age and type of medical condition.
Specific Issues
Specific issues to be addressed fall under three broad categories: the
science base, therapeutic use, and economics.
Science Base
Review of neuroscience related to marijuana, particularly
relevance of new studies on addiction and craving
Review of behavioral and social science base of marijuana use,
particularly assessment of the relative risk of progression to
other drugs following marijuana use
Review of the literature determining which chemical components of
crude marijuana are responsible of possible therapeutic effects
and for side effects
Therapeutic Use
Evaluation of any conclusions on the medical use of marijuana
drawn by other groups
Efficacy and side-effects of various delivery systems for
marijuana compared to existing medications for glaucoma, wasting
syndrome, pain, nausea, or other symptoms
Differential effects of various forms of marijuana that relate to
age or type of disease.
Economics
Costs of various forms of marijuana compared with costs of
existing medications for glaucoma, wasting syndrome, pain, nausea,
or other symptoms
Assessment of differences between marijuana and existing
medications in terms of access and availability
These specific areas, along with the assessments described above will
be integrated into a broad description and assessment of the available
literature relevant to the medical use of marijuana.
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APPENDIX D
Recommendations made in Recent Reports on the Medical Use of Marijuana
Recommendations from five recent key reports pertaining to the medical
use of marijuana are listed by subject. Recommendations made on issues
outside the scope of his report, such as drug law and scheduling clecisions,
are not included here. The following reports were reviewed:
Health Council of the Netherlands, Standing Committee on Medicine.
1996. Marihuana as medicine. Rijswikj, the Netherlands: Health
Council of the Netherlands.
Report of the Council on Scientific Affairs. 1997. Report to the
AMA House of Delegates. Subject: Medical Marijuana.
British Medical Association. 1997. Therapeutic uses of cannabis.
Harwood Academic Publishers, United Kingdom.
National Institutes of Health. 1997. Workshop on the medical
utility of marijuana. Bethesda, MD: National Institutes of Health.
World Health Organization. 1997. Cannabis: a health perspective
and research agenda.
November 1998, the British House of Lords Science and Technology
Committee published, Medical Use of Cannabis, in which they reported their
conviction that "cannabis almost certainly does have genuine medical
applications." The House of Lords report was released too late in the
preparation of the IOM report to permit careful analysis, and is not
summarized here.
It is available on the internet at: www.parliament uk.
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Appendix D
General recommendations
Health Council of the Netherlands
In order to assess the efficacy of marihuanaand cannabinoids, the
committee studied literature published during the past 25 years. Based
on
their findings, the committee concluded that there was insufficient evidence
to justify the medical use of marijuana.
AMA House of Delegates
Adequate and well-controlled studies of smoked marijuana be conducted
in patients who have serious conditions for which preclinical, anecdotal,
or
controlled evidence suggests possible efficacy including AIDS wasting
syndrome, severe acute or delayed emesis induced by chemotherapy, multiple
sclerosis, spinal cord injury, dystonia, and neuropathic pain.
British Medical Association
Further research is required to establish suitable methods of
administration, optimal dosage regimens and routes of administration for
the
above indications.
National Institutes of Health
For at least some potential indications, marijuana looks promising enough
to
recommend that there be new controlled studies done for the following
indications: appetite stimulation and wasting, chemotherapy-induced nausea
and vomiting, neurological and movement disorders, analgesia, glaucoma
(but
see note below). Until studies are done using scientifically acceptable
clinical trial design and subjected to appropriate statistical analysis,
the
question concerning the therapeutic utility of marijuana will likely remain
largely unanswered.
World Health Organization
Therapeutic uses of cannabinoids warrant further basic pharmacological
and experimental investigation and clinical research into their
effectiveness. More research is needed on the basic neuropharmacology
of THC
and other cannabinoids so that better therapeutic agents can be found.
Analgesia
Health Council of the Netherlands
No recommendations
AMA House of Delegates
Controlled evidence does not support the view that THC or smoked
marijuana offer clinically effective analgesia without causing significant
adverse events when used alone Preclinical evidence suggests that
cannabinoids can potentiate opioid analgesia and that cannabinoids may
be
effective in animal models of neuropathic pain. Further research into
the
use of cannabinoids in neuropathic pain is warranted.
British Medical Association
The prescription of nabilone, THC and other cannabinoids should be
permitted for patients with intractable pain. Further research is needed
into the potential of cannabidiol as an analgesic in chronic, terminal
and
post-operative pain.
National Institutes of Health
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Appendix D
Evaluation of cannabinoids in the management of neuropathic pain,
including HIV-associated neuropathy, should be undertaken.
World Health Organization
No recommendations, although the report notes that some newly
synthesized cannabinoids are extremely potent analgesics, however,
separation of the analgesia and side effects remains to be demonstrated.
Nausea and vomiting
Health Council of the Netherlands
No recommendations
AMA House of Delegates
Research involving THC and smoked marijuana should focus on their
possible use in treating delayed nausea and vomiting, and their adjunctive
use in patients who respond inadequately to 5-HT3 antagonists. The use
of an
inhaled substance has the potential for benefit in ambulatory patients
who
are experiencing the onset of nausea, and are thus unable to take oral
medications.
British Medical Association
Further research is needed on the use of A8-THC as an anti-emetic, the
use of cannabidiol in combination of THC, and the relative effectiveness
of
cannabinoids compared with 5-HT3 antagonists. Further research is needed
in
other cases, such as post-operative nausea and vomiting.
National Institutes of Health
Inhaled marijuana merits testing in controlled, double-blind,
randomized trials for nausea and vomiting.
World Health Organization
More basic research on the central and peripheral mechanisms of the
effects of cannabinoids on gastrointestinal function may improve the ability
to alleviate nausea and emesls.
Wasting syndrome and appetite stimulation
Health Council of the Netherlands
No recommendations
AMA House of Delegates
THC is moderately effective in the treatment of AIDS wasting, but its
long duration of action and intensity of side effects preclude routine
use.
The ability of patients who smoke marijuana to titrate their dosage
according to need and the lack of highly effective, inexpensive options
to
treat this debilitating disease create the conditions warrants formal
clinical trial of smoked marijuana as an appetite stimulant in patients
with
AIDS wasting syndrome.
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Appendix D
National Institutes of Health
There is a need for further research where long term administration of
marijuana might be considered for therapeutic purposes. individuals who
are
HIV-positive or who have tumors or diseases where immune system function
may
be important in the genesis of the disease.
Areas of study for the potential appetite-stimulating properties of
marijuana include the cachexia of cancer, HIV/AIDS symptomatology, and
other
wasting syndromes. Investigations should be designed to assess long-term
effects on immunology status, the rate of viral replication, and clinical
outcomes in participants as well as weight gain . In therapeutic trials
of
cachexia, research should attempt to separate out the effect of marijuana
on
mood versus appetite. Some questions need to be answered in the studies:
(1)
Does smoking marijuana increase total energy intake in patients with
catabolic illness. (2) Does marijuana use alter energy expenditure? (3)
Does
marijuana use alter body weight, and to what extent? (4) Does marijuana
use
alter body composition and to what extent?
World Health Organization
No specific recommendation, although the report notes that dronabinol
is an effective appetite stimulant for patients with AIDS wasting syndrome.
Muscle spasticity
Health Council of the Netherlands
No recommendations
AMA House of Delegates
Considerably more research is required to identify patients who may
benefit from THC or smoked marijuana, and to establish whether responses
are
primarily subjective in nature. A therapeutic trial of smoked marijuana
or
THC may be warranted in patients with spasticity who do not derive adequate
benefit from available oral medications, prior to their considering
intrathecal baclofen therapy or neuroablative procedures.
British Medical Association
A high priority should be given to carefully controlled trials of
cannabinoids in patients with chronic spastic disorders which have not
responded to other drugs are indicated. In the mean time, there is a case
for the extension of the indications for nabilone and THC for use in chronic
spastic disorders unresponsive to standard drugs.
National Institutes of Health
Few available therapies provide even partial relief for the neuropathic
pain that complicates many diseases affecting the central nervous system.
Cannabinoid drugs are potentially valuable in these areas, especially
if
deivered by other than the smoked route. More research is needed.
Movement disorders
Health Council of the Netherlands
No recommendations
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Appendix D
AMA House of Delegates
Considerably more research is required to identify dystonic patients
who may benefit from THC or smoked marijuana, and to establish whether
responses are primarily subjective in nature.
British Medical Association
The potential of (+) 210 for neruodegenerative disorders should be
explored through further research
National Institutes of Health
More studies are needed in movement disorders
World Health Organization
No recommendations, although the report notes that cannabinoids have
not yet been proven useful in the treatment of convulsant or movement
disorder or in treating multiple sclerosis.
Epilepsy
Health Council of the Netherlands
No recommendations
AMA House of Delegates
No recommendations
British Medical Association
Trials with cannabidiol (which is non-psychoactive) used to enhance the
activity of other drugs in cases not well controlled by other anticonvulants
are needed.
National Institutes of Health
No recommendations
World Health Organization
No recommendations
Glaucoma
Health Council of the Netherlands
No recommendations
AMA House of Delegates
Neither smoked marijuana nor THC are viable approaches in the treatment
of glaucoma, but research on their mechanism of action may be important
in
developing new agents that act in an additive or synergistic manner with
currently available therapies
British Medical Association
Cannabinoids do not at present look promising for these indications,
but much further basic and clinical research is needed to develop and
investigate cannabinoids which lower intraocular pressure, preferably
by
topical application (ea. eye drops, inhalant aerosols), without producing
unacceptable systemic and central nervous system effects.
National Institutes of Health
Further studies to define the mechanism of action and to determine the
efficacy of delta9-tetrahydrocannabinol and marijuana in the treatment
of
glaucoma are justified.
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Appendix D
World Health Organization
No recommendations
Physiological harms
Health Council of the Netherlands
No recommendations
AMA House of Delegates
No recommendations
British Medical Association
Further research is needed to establish the suitability of cannabinoids
for immunocompromised patients, such as those undergoing cancer chemotherapy
or with HIV/AIDS.
National Institutes of Health
Additional studies of long term marijuana use are needed to determine
if there are or are not important adverse pulmonary, central nervous system
(CNS), or immune system problems. The suggested design for clinical studies
is to add marijuana, oral THC, or placebo to standard therapy under
double-blind conditions: (1) Establish dose-response and dose-duration
relationships for IOP and CNS effects. (2) Relate IOP and blood pressure
measurements longitudinally to evaluate potential tolernce development
to
cardiovascular effects. (3) Evaluate CNS effects longitudinally for
tolerance development.
World Health Organization
Further studies are required of marijuana use on fertility effects,
respiratory function and disease, immunological function, and cardiovascular
effects.
Psychological harms
Health Council of the Netherlands
No recommendations
AMA House of Delegates
No recommendations
British Medical Association
No recommendations
National Institutes of Health
No recommendations
World Health Organization
There is a need for controlled studies investigating the relationships
between cannabis use, schizophrenia and other serious mental disorders.
Insufficient research has been undertaken on the 'amotivational' syndrome
which may or may not result from heavy cannabis use. It is not clear that
the syndrome exists, even though heavy cannabis use is sometimes associated
with reduced motivation to succeed in school and work. New research is
needed to show whether the reduced motivation seen in some cannabis users
is
due to other psychoactive substance use and whether it precedes cannabis
use. Further
----------------------------------------------------------------------------
Appendix D
development of cognitive and psychomotor tests for controlled studies
that
are sensitive to the performance effects of cannabis use and that reflect
the complexity of specific daily functions (e.g., driving, learning,
reasoning) also need additional research. More research in examining the
relationship between THC concentrations in blood and other fluids and
the
degree of behavioral impairment produced.
Physiological harms
Health Council of the Netherlands
No recommendations
AMA House of Delegates
No recommendations
British Medical Association
No recommendations
National Institutes of Health
There significant health risks associated with smoked marijuana that
must be considered not only in terms of immediate adverse effects, but
also
long-term effects in patients with chronic diseases. The possibility that
frequent and prolonged marijuana use might lead to clinically significant
impairments of immune system function is great enough that relevant studies
should be part of any marijuana medication development research.
World Health Organization
Research on chronic and residual cannabis effects is also needed. The
lack of knowledge restricts the ability of researchers to relate drug
concentrations in blood or other fluids and observed effects.
More studies are needed on the fertility effects in cannabis users, in
view of the high rate of use during the early reproductive years.
More research is required on the effects of cannabis on respiratory
function and respiratory diseases. More studies on whether cannabis affects
the risk of lung malignancies and what level of use that may occur. More
studies are needed to clarify the rather different results of pulmonary
histopathological studies in animals and man.
More clinical and experimental research is needed on the effects of
cannabis on the immunological function. More clarity should be sought
concerning the molecular mechanisms responsible for immune effects,
including both cannabinoid receptor and non-receptor events.
The possibility that chronic cannabis use has adverse effects on the
cardiovascular system.
Smoked marijuana and use of plants as medicine
Health Council of the Netherlands
Not recommended. The committee believes that physicians cannot accept
responsibility for a product of unknown composition that has not been
subjected to quality control
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Appendix D
AMA House of Delegates
NIH should use its resources to support the development of a smoke-free
inhaled delivery system for marijuana or THC to reduce the health hazards
associated with the combustion and inhalation of marijuana.
British Medical Association
Prescription formulations of cannabinoids or substances acting on the
cannabinoid receptors should not include either cigarettes or herbal
preparations with unknown concentrations of cannabinoids or other chemicals.
National Institutes of Health
NIH should use its resources and influence to rapidly develop a
smoke-free inhaled delivery system for marijuana or THC. This will also
bring this research effort in line with other Government initiatives to
curtail cigarette smoking. "Taking the smoke" out of an inhaled dosage
form
of marijuana or THC would remove an important obstacle to the accurate
determination of inhaled marijuana's beneficial and deleterious effects.
World Health
Not discussed in the context of medical use, although many health
hazards associated with chronic marijuana smoking are noted.
Drug development
Health Council of the Netherlands
Not discussed
AMA House of Delegates
NIH should use its resources to support the development of a smoke-free
inhaled delivery system for marijuana or THC to reduce the health hazards
associated with the combustion and inhalation of marijuana.
British Medical Association
Pharmaceutical companies should undertake basic laboratory
investigations and develop novel cannabinoid analogues which may lead
to new
clinical uses.
National Institutes of Health
NIH should use its resources and influence to rapidly develop a
smoke-free inhaled delivery system for marijuana or THC. This will also
bring this research effort in line with other Government initiatives to
curtail cigarette smoking. "Taking the smoke" out of an inhaled dosage
form
of marijuana or THC. would remove an important obstacle to the accurate
determination of inhaled marijuana's beneficial and deleterious effects.
World Health Organization
Not discussed.
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APPENDIX E
Rescheduling Criteria
DEA's Five Factor Test for Rescheduling
(Formulated in 1992 in Response to Court Challenge to Scheduling)
(1) The Drug's Chemistry Must Be Known and Reproducible
The substance's chemistry must be scientifically established to permit
it to be reproduced in dosages which can be standardized. The listing
of the
substance in a current edition of one of the official as defined by section
201 (I) of the Food, Drug and Cosmetic Act, 21 USC 321(f), is sufficient
generally to meet this requirement.
(2) There Must be Adequate Safety Studies
There must be adequate pharmacological and toxicological studies done
by all methods reasonably applicable on the basis of which it could be
fairly and responsibly concluded, by experts qualified by scientific
training and experience to evaluate the safety and effectiveness of drugs,
that the substance is safe for treating a specific, recognized disorder.
(3) There Must Be Adequate and Well-Controlled Studies Proving Efficacy
There must be adequate, well-controlled, well-designed, well-conducted,
and well documented studies, including clinical investigations, by experts
qualified by scientific training and experience to evaluate the safety
and
effectiveness of drugs on the basis of which it could fairly and responsibly
be concluded by such experts, that the substance will have its intended
effect in treating a specific, recognized disorder.
(4) The Drug Must Be Accepted by Qualified Experts
The drug must have a New Drug Application (NDA) approved by the Food
and Drug Administration...Or, a consensus of the national community of
experts, qualified by scientific training and experience to evaluate the
safety and effectiveness of drugs, accepts the safety and effectiveness
of
the substance for use in treating a specific, c, recognized disorder.
A
material conflict of opinion among experts precludes a finding of consensus.
(5) The Scientific Evidence Must Be Widely Available
In the absence of NDA approval, information concerning the chemistry,
pharmacology, toxicology and effectiveness of the substance must be
reported, published, or otherwise widely available in sufficient detail
to
permit experts, qualified by scientific training and experience to evaluate
the safety and effectiveness of drugs, to fairly and responsibly conclude
the substance is safe and effective for use in treating a specific,
recognized disorder.
Sources: LeCraw (1996) and 57 Fed. Reg. 10499- (1992).
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