Last updated on: 5/30/2008 | Author:

What Is the US government’s Compassionate Investigational New Drug (IND) Program for Medical Marijuana?

General Reference (not clearly pro or con)

The government marijuana distributed to federal IND patients
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The National Institute on Drug Abuse (NIDA) stated the following in a Jan. 1998 report titled “Provision of Marijuana and Other Compounds for Scientific Research – Recommendations of the National Institute on Drug Abuse National Advisory Council,” available on the NIDA website:

“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 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 storage for up to five years.”

Jan. 1998 - National Institute on Drug Abuse (NIDA)

The US Food and Drug Administration (FDA) stated the following in an article dated Feb. 12, 2002 on its website:

“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.”

Feb. 12, 2002 - US Food and Drug Administration (FDA)

The Marijuana Policy Project’s 2002 “Medical Marijuana Briefing Paper” stated:

“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 (MPP)

Robert C. Randall, a glaucoma patient who, in 1978, became the first individual granted the legal right to regularly use marijuana medically, in 1999 co-wrote with his wife Alice O’Leary the following description of the halting of the Compassionate Investigational New Drug (IND) Program for medical marijuana:

“[I]n the early 1990s when FDA [U.S. Food and Drug Administration] 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 [U.S. Drug Enforcement Administration] 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.”

1999 - Robert C. Randall