EDITORS NOTE: Schedule I substances are considered "dangerous
narcotics with NO KNOWN MEDICAL APPLICATIONS."
______________________________________________________________
Excerpted from U.S. Federal Court Decision in the Case of Alliance
for Cannabis Therapeutics, et al., vs. U.S. Drug Enforcement
Administration (IRS):
          In the Matter of MARIJUANA MEDICAL RESCHEDULING PETITION
          September 6, 1988, Docket No. 86-22:FRANCIS L. YOUNG,
          Administrative Law Judge
     "Based upon the facts established in this record and set
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...."
     "The cannabis plant considered as a whole has a currently
accepted medical use in treatment in the United States, there is no
lack of accepted safety for use under medical supervision and it
may lawfully be transferred from Schedule I to Schedule II. The
judge recommends that the Administrator transfer cannabis."
_________________________________________________________________ 
          Section III: Issues To Be Heard And Decided In This Case
          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.
     VII: Cannabis/Marijuana's Accepted Safety For Use Under
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 (cannabis) 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
cannabis encompasses 5,000 years of human experience. Second,
cannabis is now used daily by enormous numbers of people throughout
the world. Estimates suggest that 20-million to 50-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 cannabis has caused a single death.
     6. By contrast aspirin, a commonly used, over-the-counter
medicine, causes hundreds of deaths each year.
     7. Drugs 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
cannabis's LD-50 rating in test animal, without success. Simply
stated, researchers have been unable to give animals enough
cannabis to induce death.
     8. At present it is estimated that cannabis'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 cannabis as is contained within about 15
minutes to induce a lethal response.
     9. In practical terms, cannabis 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 anti-neoplastic
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 may
foods we commonly consume. For example, eating 10 raw potatoes can
result in toxic response. By comparison, it is physically
impossible to eat enough cannabis 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 cannabis can be safely used with a supervised
routine of medical care.
     18. There have been occasional instances of panic reaction in
patients who have smoked marijuana. These have occurred in
cannabis-naive persons, usually older persons, who are extremely
anxious over the forthcoming chemotherapy and troubled over the
illegality of their having obtained the cannabis. Such persons have
responded to simple person-to-person communication with a doctor
and have sustained no long term mental or physical damage. If
cannabis 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 cannabis have been minimal.
Sedation often results. Sometimes mild euphoria is experienced.
Short periods of increased pulse rate and of dizziness are
occasionally experienced. Cannabis 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
cannabis were being employed as an agent under medical supervision.
     DISCUSSION OF LEGAL OBLIGATIONS
     The Act, at 21 USC 812(b)(1)(C), requires that marijuana be
retained in Schedule I if "there is lack of accepted safety for use
of [it] under medical supervision," then it is unreasonable to keep
it in Schedule I. The only proper question for the Agency here is:
Have a significant minority of physicians accepted cannabis as safe
for use under medical supervision?
     The gist of the Agency's case against recognizing cannabis'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 cannabis 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 conclude that there is accepted safety for use of
cannabis under medical supervision. To conclude otherwise, on this
record, would be unreasonable, arbitrary and capricious.
          IX. CONCLUSION & RECOMMENDED DECISION
     Based upon the foregoing facts and reasoning, the
administrative law judge conclude that the provisions of the Act
permit and require the transfer of cannabis from Schedule I to
Schedule II. The judge realizes strong emotions are aroused on both
sides of any discussion concerning the use of cannabis. 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 can be 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 cannabis 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 cannabis can
actually be legally available. This Agency is charged merely with
determining the placement of cannabis 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 cannabis 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 cannabis should be
placed in Schedule II, in obedience to the law, then that is where
cannabis 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
sufferers for the relief cannabis can provide when prescribed by a
physician in a legitimate case.
     The evidence in this record clearly shows that cannabis has
been accepted as capable of relieving the distress from great
numbers of very ill people, and doing so with safety under medical
supervision. It would be unreasonable, arbitrary and capricious for
the DEA to continue to stand between those sufferers and the
benefits of this substance in the light of the evidence in this
record.
     The administrative law judge recommends that the Administrator
conclude that the cannabis 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 cannabis from Schedule I to Schedule II.
Francis L. Young
DEA Administrative Law Judge
          APRIL 1991:DECISION UPHELD BY FEDERAL APPEALS COURT
     Docket No.90-1020:"The DEA Administrator exercised with a
vengeance his prerogative to reject the recommended decision."
END