What is the U.S. government’s Compassionate Investigational New Drug (IND) program for medical marijuana

What is the U.S. government’s Compassionate Investigational New Drug (IND) program for medical marijuana?

Issue: U.S Government & Medical

Sub-Issue: The 7 Legal U.S. Medical
Marijuana Patients

Q: What is the
U.S. government’s Compassionate Investigational New Drug
(IND) program for medical marijuana?

General Reference
(not clearly pro or con)

Photos of the government
distributed to federal IND patients

Photos by

The National Institute on Drug Abuse (NIDA) states in
their January 1998 subcommittee report on their practice and costs of
growing marijuana and supplying it to researchers, the DEA, and 7

"The National Institute of Drug Abuse (NIDA)
administers a contract with the University of Mississippi to grow
cannabis for research purposes and is the only legal source for cannabis
[marijuana] in the United States.

NIDA also supplies cannabis to seven patients under
single patient so-called ‘compassionate use’ Investigational New Drug
Applications (IND). In 1978, as part of a lawsuit settlement by the
Department of Health and Human Services, NIDA began supplying cannabis
to patients whose physicians applied for and received such an USID from
from the FDA. In 1992 the Secretary [of Health and Human Services]
terminated this practice, but decided that NIDA should continue to
supply those patients who were receiving cannabis at the time.

NIDA has overseen the farm since the institute’s
inception in 1974. NIDA’s predecessor, National Institutes of Mental
Health, founded a drug supply program in 1968 to provide researchers
with the compounds necessary to conduct biomedical research and cannabis
was among the first substances to be made available. They ‘provide a
contamination-free source of cannabis material with consistent and
predictable potency’ (as per NIDA, 1-98) for biomedical research.

The University of Mississippi has the option to grow
either 1.5 or 6.5 acres of cannabis per year or to not grow any,
depending on demand.

Generally (as of January 1998) 1.5 acres are grown in
alternate years which can typically produce 50,000-60,000 cigarettes per
year of three grades of potencies [strength 1: 3-4% THC; strength 2:
1.8-2.2% THC; strength 3: placebo, as close to 0% THC as possible].
Virtually all of the nearly 65,000 cigarettes produced between 1994-1996
were for single patients.

As of March 1997 there were 278,100 cigarettes in stock
which are maintained in frozen
for up to five years."

(1/98) National Institute on Drug Abuse 

The U.S. Food and Drug Administration states on their web
site in an article dated 2/12/02:

"Access to unapproved drugs can occur through many
legal mechanisms, including enrolling in clinical trials, a special
exception or compassionate exemption, an emergency Investigational New
Drug (IND), and a Treatment IND.

If the eligibility criteria in a study protocol are not
suitable for a particular patient, it may still be possible to be
treated according to the study protocol as a special exception
(sometimes called compassionate exemption).

Treating a patient as an exception is at the discretion
of the investigator and sponsor, and usually requires filing extra
paperwork, including sending a request to the FDA."

(2/12/02) U.S. Food and Drug Administration

The Marijuana Policy Project’s 2002 "Medical Marijuana
Briefing Paper" states:

"In 1975, Robert Randall, who suffered from glaucoma,
was arrested for cultivating his own marijuana. He won his case by using
the "medical necessity defense,", forcing the government to find a way
to provide him with his medicine. As a result, the Investigational New
Drug (IND) compassionate access program was established, enabling some
patients to receive marijuana from the government.

In 1992, in response to a flood of new applications
from AIDS patients, members of the Bush administration closed the
program to all new applicants. On December 1, 1999, the U.S. Department
of Health and Human Services updated its medical marijuana policy,
restating that the IND program would not be reopened. Consequently, the
IND program remains in operation only for the seven surviving previously
approved patients."
(2002) Marijuana Policy Project

Robert Randall, a glaucoma patient, who became the first
individual (1978) granted the legal right to regularly use marijuana
medically, co-wrote the following (with his wife Alice O’Leary)
description of the halting of the Compassionate IND Program for medical

"[I]n the early 1990s when FDA was compelled to expand
the nation’s Compassionate IND program for medical marijuana to include
HIV+ people and Americans afflicted by neurologic disorders like
paralysis, multiple sclerosis, and muscular dystrophy…. federal drug
agencies were whipsawed by these accelerating demands for care.

DEA steadfastly maintained marijuana has no medical value even
as FDA authorized marijuana’s compassionate medical use for the
treatment of an expanding number of life- and sense-threatening
diseases. By April 1991, this profound contradiction in federal policy
brought the medical prohibition into crisis….

In March 1992,
War on Drugs hardliners in the bureaucracy won. Bush killed FDA’s
Compassionate IND program for medical marijuana. FDA dumped hundreds of
Compassionate IND applications into the trash and scores of patients
were arbitrarily denied promised access to medical care. Only a handful
of patients — those already receiving medical marijuana — were
spared."  [Read
the full document

(1999) Robert Randall



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