MEDICAL USE OF WHOLE CANNABIS:
Statement of the Federation of American Scientists
 SUMMARY
The federal government, particularly through the Drug Enforcement
Administration, has strongly resisted research on the therapeutic
uses of whole cannabis, though there is good prima facie evidence that 
it might make valuable contributions to the treatment of a variety of
significant problems.  Moreover, despite its illegality, whole
cannabis is in clinical use; thus even negative results would have
practical use.  
The federal government should remove legal barriers to research, provide
direct or indirect financial support to research and, in the meantime,
allow continued and expanded use of the drug under a compassionate
research program for patients who doctors prescribe whole marijuana.
 BACKGROUND
While a synthetic version of delta-9 tetrahydrocannabinol (THC), the main
psychoactive agent in Cannabis (marijuana), is legally available in the
United States for medical use, the plant material itself, and all of its
other active agents, remain forbidden.[1]  Even the Compassionate
Investigative New Drug program, under which a handful of patients
receive government-produced whole cannabis for the treatment of various
conditions, has been closed to new applicants.[2]
Anecdotal accounts testify to the potential value of whole cannabis in a
wide range of conditions, including appetite enhancement for the wasting
syndrome of AIDS, control of nausea and vomiting associated with cancer
chemotherapy, relief of spasticity and pain associated with multiple
sclerosis, and control of migraine headaches and epileptic seizures.[3]
A substantial proportion of practicing oncologists regard cannabis as a
safe and effective anti-nausea agent.[4].
If indeed whole smoked cannabis has greater efficacy or lesser side
effects than oral delta-9 THC for some patients or conditions - one
careful, though non-randomized, clinical study with chemotherapy patients
has shown greater efficacy [5] - that might be due either to the
advantages of inhaled over oral administration (speed of action plus
more reliable bioavailability [6] and the consequent ability of patients
to self-titrate dosage) or to the action of one or more of the dozens of 
active agents in whole cannabis, or their interactions with each other and
with delta-9 THC.  One study with healthy volunteers showed that a
combination of THC with cannabidiol, another chemical in whole cannabis,
tends to be less anxiety-provoking than THC alone.[7]  Despite its
illegality, whole cannabis is in clinical use.  In a survey of
practicing oncologists, more than four in ten reported having
recommended the material for use by one or more patients.[8]  
A substantial number of AIDS patients reportedly use whole cannabis,
either smoked or orally, as an appetite enhancer, and some of the
"buyers' clubs" which acquire non-FDA-approved medicines for 
such patients apparently are now handling illegal cannabis as well.[9]
Even at black-market prices, whole cannabis is substantially less
expensive per bioavaliable milligram of THC than is the legal synthetic,
sold under the trade-name Marinol.
An unknown number of persons growing cannabis for their own medical use or
distributing it for medical use by others have been arrested, prosecuted,
and had homes and other assets seized and forfeited to the government.
In a few well-publicized cases, charges of marijuana production or 
distribution have been dropped or convictions overturned based on the
defense of "medical necessity;" at least one such defendant has been
subsequently re-arrested.[10]  The absurd and obscene spectacle of
physicians sending patients to black-market drug dealers for medicine,
and other producers and consumers of a therapeutic agent risking arrest,
must end.
TITLE LEGAL AND REGULATORY SITUATION
Legally, there are two barriers to the medical use of whole cannabis.
First, cannabis is a "controlled substance," which cannot be produced,
distributed, or possessed except for approved medical or research
purposes. Second, cannabis has not been approved by the Food and Drug 
Administration as a safe and effective treatment for any condition,
which as a legal matter means that it cannot be produced by a drug
company, distributed by a pharmacist, or prescribed by a physician.
In the ordinary course of things, when a new drug is developed there
is a sponsoring company that is willing to spend the millions of dollars
required to perform the research needed to secure New Drug Approval from
the FDA, because the company's patent on the new compound will allow it
to charge monopoly prices once it has been approved.  But cannabis is
not a new drug; its medical use is thousands of years old, and it was
listed in the United States Pharmacopoeia until 1937.  Therefore it
lacks drug-company sponsorship.  Moreover, the FDA process is biased 
towards refined or synthetic compounds and against herbal medicines,
whose natural variability makes them more difficult subjects of
research, independent of whether their actual clinical performance is
better or worse than their refined or synthetic competitors.
These economic and regulatory facts are half of the explanation for the
relative paucity of carefully controlled clinical studies.
THE POLITICAL SITUATION
The other explanation for the lack of research is that the struggle over
the medical use of cannabis has been caught up in the larger battle over
its legal availability for non-medical purposes.  As a logical matter,
there is no reason for the two issues to be confused.
Cocaine and morphine are both legal medicines, and that does not seem to
have confused anyone about their danger as drugs of abuse.  Nor have
legal cocaine or morphine supplies added in any significant measure to
the illicit markets for cocaine or the opiates.
But, as a political matter, medical marijuana has been seen as a
front-line battle in the war about the War on Drugs.  Patients have been
the collateral casualties of this misconceived battle.  
The most recent instance of this is the decision by a second-level
official at the Drug Enforcement Administration, a lawyer without any
research or medical credentials, to block the supply of cannabis for
an FDA-approved study by a leading AIDS researcher on the use of
whole cannabis in the wasting syndrome of AIDS, because some of the
people supporting it have politically incorrect views on drug abuse
control policy.
Putting the substance of the medical cannabis question aside, it is an
outrage for a law enforcement official to interfere with medical
research.  Anyone curious about what becomes of a society where the
government blocks any scientific research that might lead to politically
inconvenient results could learn much by studying conditions in Leningrad
or the German Democratic Republic.
NEXT STEPS
The most important thing the Federal government needs to do about medical
cannabis is to get out of the way of research.  A recent report by the
Institute of Medicine recommended removing the power of the Drug
Enforcement Administration over research with Schedule I (non-approved) 
drugs, [11] and the story of the study of cannabis for the AIDS wasting
syndrome strongly suggests that the suggestion was a wise one.
At the same time, funds need to be made available to get the necessary
clinical studies done, either directly through the National Institutes of
Health or indirectly by giving some firm or non-profit entity limited
patent protection for cannabis under the Orphan Drug Development program.
As part of that funding process either the NIH or the organization which
assumes the sponsorship of medical cannabis research should set aside
money to supply cannabis on a compassionate basis to patients whose
physicians certify they need it, even before it receives formal 
approval. The compassionate IND program, as it was called, was canceled
as it applied to marijuana partly for ideological reasons and partly
because an upsurge of demand for cannabis from AIDS patients threatened
to exhaust the NIDA budget. That program should be restarted, but in a
way that yields usable research results.  A methodology that would
accomplish this goal has been proposed by FDA.
But compassionate use, as urgent as it is to those currently suffering,
is only a stop-gap. There is no substitute for clinical research that
alone can make cannabis an approved medicine, available as other
medicines are through ordinary pharmaceutical channels.
Prepared by Mark A.R. Kleiman
Chairman, FAS Committee on Drug Policy
Footnotes:
[1] In June 1985, FDA approved the synthetic drug for marketing under the
chemical name dronabinol, and the trade name Marinol.  In April 1986, DEA
rescheduled synthetic THC to Schedule 2.
[2] The program was closed to new applicants during the Bush
Administration by Assistant Secretary of Health James O. Mason.  Dr.
Phillip Lee, the current Assistant of Health, reviewed the decision 
by his predecessor and in July, 1994 decided to keep the Compassionate
program closed on the grounds that the program "is not the type of
clinical trial that would produce useful scientific information." 
Letter from Dr. Lee to Rep. Barney Frank.
[3] Grinspoon, D L and Bakalar, J. _Marijuana, the Forbiddden Medicine_,
Yale University Press.  New Haven, CT 1993.
[4] Doblin R, Kleiman MAR. Marijuana as antiemetic medicine; A survey of
oncologists' experience and attitudes. _J Clin Oncol._ 1991;9:1314-1319.
[5] Vinciguerra V, Moore T, Brennen E. Inhalation of marijuana as an
antiemetic for chemotherapy.  _NY State J Med_, 1988; 88:525-527.
[6] Ohlsson A, Lindgren JE, Wahlen A, et al. Plasma x-9,THC
concentrations and clinical effects after oral and intravenous
administration and smoking.  _ClinPharmacol Ther._ 1980;28:409-416.
[7] Zuardi AW, Shirakawa E, Finkelharb E, Karniol IG.  Action of
cannabidiol on the anxiety and other effects produced by x9-THC in
normal subjects. _Psychopharm_ 1982;76:245-250.
[8] Doblin R, Kleiman MAR. _Medical Use of Marijuana Annals Int Med._
1991;114:809-810.
[9] Simmers, Tim. Many Chronically Ill Find Relief in Marijuana Shop,
_Oakland Tribune_, September 18, 1994. p.D1.
[10] Vallarie Corral is the person arrested twice.  She is both a
marijuana patient and a grower/distributor to other patients.
[11] Development of Anti-Addiction Medications: Issues for the
Government and Private Sector.  Committee to Study Medication
Development and Research at the National Institute on Drug Abuse.  
Division of Biobehavioral Sciences and Mental Disorders.  Institute of
Medicine. 1994.
ABOUT THE FEDERATION OF AMERICAN SCIENTISTS
"There is no other group that so truly represents the conscience of the
American scientist as the FAS."
--Jerome B. Weisner
Science Advisor to Presidents Kennedy and Johnson
The Federation of American Scientists, born as the Federation of Atomic
Scientists (FAS), is the oldest organization dedicated to ending the
arms race and avoiding the use of nuclear weapons.  FAS combines the
scholarly resources of its scientists, including 47 Nobel laureates,
with a knowledge of practical politics.  As a non-profit organization
licensed to lobby in the public interest, FAS is uniquely 
qualified to bring the scientific perspective to the legislative arena
through direct lobbying, membership and grassroots work, and expert
testimony at Congressional hearings.
Federation of American Scientists
307 Massachusetts Avenue, N.E.
Washington, D.C. 20002  (202) 546-3300
___
 X Blue Wave/QWK v2.20 X
--- Maximus 3.01
---------------