Department of Health and Human Services
Talking Points on Medical Marujuana Policy 7/12/94

Public Health Service
Office of the Assistant Secretary for Health
Washington DC 20201

1. Background:

In 1978, as a result of a settlement agreement in a lawsuit against the government, a procedure was devised to allow patients to receive marijuana cigarettes under the single patient investigative new drug (IND) procedure at FDA., This procedure allows individuals whose physicians think they will benefit from unapproved drugs to receive them. From that time until June, 1991, about fifteen patients were awarded single patient INDs for marijuana cigarettes.

In 1991, marijuana activists started advertising the free medicinal marijuana policy and offering assistance to anyone who wanted to apply to FDA. This publicity led to a tripling in the number of applications to FDA, which would have exhausted the government research supply, and triggered a review of the policy by then Assistant secretary for health, James 0. Mason, M.D. Pending applications -- most of them from patients with HIV wasting syndrome -- were put on hold during the review.

2. History of Research:

In an effort to determine the efficacy of smoked marijuana NIH reviewed available research on the substance as a treatment for symptoms associated with five diseases and decided that there was no evidence that smoked marijuana was better than available alternative therapies. There was also concern that smoked marijuana could be harmful to people with impaired immune systems, particularly AIDS patients, who were susceptible to lung infections such as pneumocystis pneumonia. (NIH-supported research presented at the Ninth International AIDS conference in Berlin in the summer of 1993 has increased these concerns, showing that smoking marijuana is significantly associated with bacterial pneumonia among XIV-infected individuals.)

In March of 1992, the HHS secretary decided that PHS would not supply any marijuana to now patients applying for it under the single patient IND. Physicians for patients with pending applications were contacted and counseled on alternative therapies. Patients already receiving marijuana cigarettes under the program were also contacted and encouraged to find alternative therapies. If, however, they wanted to continue receiving the marijuana, they were allowed to do so.

3. Current Policy on Medicinal marijuana:

PHS will not reopen the single patient investigational new drug program for therapeutic marijuana to additional patients.

At the request of members of Congress, a review of the medicinal marijuana policy was initiated in 1993.

Scientists at NIH have again concluded, after careful reexamination of the existing data, that there is no clinical evidence from either animal or human research to suggest that smoked marijuana is superior to currently available therapies glaucoma, weight loss and wasting associated with AIDS, nausea and vomiting associated with cancer chemotherapy, muscle spasticity associated with multiple sclerosis or intractable pain.

Given the status of scientific information now available, PHS has also carefully considered whether the single patient IND process would be helpful in providing scientific evidence to support the various claims of benefits. After consultation with experts in the design of clinical studies, it is clear that the single patient IND process cannot produce useful scientific information. Under these circumstances, it would not be adequate for demonstrating safety and efficacy for the FDA approval process.

4. There Are Alternative Therapies:

Dronabinol (marketed under the trade name Marinol), contains THC, the principal active ingredient in marijuana. Marinol is commercially available as an antiemetic for cancer patients and to treat anorexia associated with weight loss in patients with AIDS.

Other drugs and treatments are available for conditions associated with requests for marijuana cigarettes including 24 drugs approved by the FDA for glaucoma and many for nausea associated with cancer chemotherapy and chronic pain. Many of these drugs are considered superior to marijuana in effectiveness and safety.

Information is available from PHS on treatments for the five illnesses associated with requests for medicinal marijuana. Patients who wish more information can have their physicians contact the expert designated by NIH in the fact sheet discussing their particular illness.

5. Possibilities for Research:

The FDA is prepared to follow its customary practice of discussing with any potential sponsors of clinical trials the federal regulations governing the use in humans of investigational new drug substances and the requirements of approval for a now medication.

As with all controlled substances, therapeutic marijuana would be subject to all of the requirements of the U.S. Controlled Substances Act. DEA must register all physicians who prescribe controlled substances. This is a process independent from FDA's review of IND applications and is also required in order for clinical studies to proceed.