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Appendixes


APPENDIX A
Workshop Agendas
APPENDIX B
Scheduling Definitions
APPENDIX C
Statement of Task
APPENDIX D
Recommendations made in Recent Reports on the Medical Use of Marijuana
APPENDIX E
Rescheduling Criteria





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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issued by the National Academy of Sciences, the National Academy of

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