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Department of Health and Human Services Provision of Marijuana and Other Compounds For Scientific Research - Recommendations of The National Institute on Drug Abuse National Advisory CouncilJanuary, 1998 ISSUE: Since its inception in 1974, NIDA has been the sole administrator of a contract to grow cannabis (marijuana) for research purposes and the only legal source for cannabis in the United States. Scientific studies require a source of cannabis materials that have consistent and predictable potency, are free of contamination, and are available in amounts to support research needs. During the 1970s the demand for cannabis materials was high. As much became known from science about the pharmacology of cannabis and its biomedical and behavioral effects, less cannabis research was done and demand for cannabis materials declined markedly. In the last decade or so the research demand has remained relatively low, such that available supply has exceeded the demand. However, recent State initiatives and an NIH-wide scientific workshop in February 1997 co-sponsored by ten NIH components have generated increased interest in research related to the potential medical uses of cannabis. Thus, there may soon be an increase in requests. Some of these requests will come from NIDA grantees or grantees of other NIH Institutes, which guarantees both a peer and Council review. Others, however, may come from individuals receiving State or private funding and may not have undergone equivalent scientific peer review. As a result of these recent developments, it has become important for NIDA to reevaluate its policies related to the Drug Supply Program, and in particular the growing and supplying of cannabis, to ensure that reviews of all proposals are objective, uniform, rigorous, and appropriate, and are so viewed by the disparate communities of interest. Accordingly, there is a need for Council to develop a set of procedures and guidelines on practical and policy issues related to the-provision of cannabis. BACKGROUND: In 1968, the National Institute of Mental Health began funding a Drug Supply Program to provide researchers with compounds necessary to conduct biomedical research. Initially, the program focused on THC and other naturally occurring cannabinoids, and then gradually expanded to a wide range of compounds. (Since its beginning, the program has synthesized or obtained over 1,500 different compounds that have been supplied to over 2,500 researchers.) Cannabis was among the first substances to be made available through the Drug Supply Program for use by scientists conducting both nonhuman research and human research under a variety of investigational new drug protocols. It was grown through a contract with the University of Mississippi. With its establishment in 1974, NIDA became the successor to NIMH as the administrator of the cannabis contract and the sole U.S. source for legal cannabis. NIDA has continued to grow cannabis in order to provide a contamination-free source of cannabis material with consistent and predictable potency for use in biomedical research. Because of international treaty agreements (Single Convention on Narcotic Drugs, 1961) which prohibit entities other than the Federal Government from legally supplying cannabis, NIDA has remained its only legal source. These same treaty agreements as well as DEA regulations require that only the amounts of cannabis needed for medical and research purposes be produced. In addition to the contract with the University of Mississippi, NIDA also supports two contracts with the Research Triangle Institute (RTI) for, among other purposes, the manufacture and distribution of standardized cannabis cigarettes. 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 terminated this practice, but decided that NIDA should continue to supply those patients who were receiving cannabis at the time. Under the current contract with the University of Mississippi for any given year NIDA has the option to grow either 1.5 or 6.5 acres of cannabis, or to not grow any at all, depending on research demand. Generally, 1.5 acres are grown in alternate years. The number of cannabis cigarettes produced from 1.5 acres is about 50,000-60,000, although it can be higher. Cigarettes are produced in three potencies: strength 1 - 3-4 %; strength 2 - 1.8-2.2 %; and strength 3 - placebo, as close to 0% as possible. During the past three years, the following quantities have been shipped: 1994 - 24,000 cigarettes; 1995 - 23, 100 - cigarettes; and 1996 17,700 cigarettes. Virtually all of the cigarettes shipped in the last three years have been for single patient INDs. As of March 1997 there were 278, 100 cigarettes in stock. The cigarettes are maintained in frozen storage and have a useful life of approximately five years. The contract with the University of Mississippi funds the growing, harvesting and storage of cannabis. It also funds potency monitoring and other services for the DEA. The total contract, including DEA activities, is about $480,000 during growing years and $350,000 during nongrowing years. Of these amounts the costs associated with cannabis are about $362,000 during growing years (for 1.5 acres) and $232,000 during nongrowing years. The remaining $118,000/year (approximately) of the contract is used for DEA activities and is not associated with the growing of cannabis. There are currently two contracts with RTI. One of these, totaling $615,571/year, funds the manufacture of cannabis cigarettes, as well as the analysis of cannabis material, and the development and production of standardized reconstituted cannabinoid preparations. About 10% of this contract ($61,557/year) is for the manufacture of cannabis cigarettes. These costs from the contracts with the University of Mississippi and RTI that are associated with the growing of cannabis and the production and shipping of cigarettes are approximately $420,000 during a growing year and $300,000 during a nongrowing year. Funding at this level allows for the production of cannabis cigarettes with a uniform potency and purity, consistency of seed stock, the analysis of THC content and adjustments when necessary, and other activities crucial to the production of research grade cannabis cigarettes. If it were necessary, NIDA could exercise a contract option with the University of Mississippi to grow an additional five acres at a cost of $310,000. Additional costs would then also be incurred in the RTI contract for the production of the cannabis cigarettes. The other RTI contract for $1,735,400/year funds the synthesis and analysis of other compounds that are available through NIDA's Drug Supply Program and the purification of other compounds. NIDA's present policy is to provide cannabis for medical research purposes to either grantees or nongrantees whose research and protocols have scientific merit, providing the research is determined to be an appropriate use of NIDA resources and the principal investigator obtains the necessary licences. For NIDA-funded projects, the project officer reviews the protocol, determines whether the amounts requested are justified and makes recommendations to the NIDA drug supply officer. If the request is from someone who is not a NIDA grantee, the project is reviewed by two outside experts for scientific merit, protocol, and amount of drug requested. Each reviewer then makes a recommendation as to whether or not NIDA should supply the cannabis. If the outside experts differ in their recommendations, a third expert is asked to review the request. In all cases, if cannabis is supplied, there is no cost to the researcher. NIDA absorbs all of the costs associated with the production and shipping of the cannabis, whether it is being provided to a NIDA grantee or a non-NIDA grantee. In recent years, growing 1.5 acres every other year has been adequate to supply both the seven patients receiving cannabis under individual patient INDs and cannabis research grants. There are indications now, however, that the number of requests may increase, perhaps dramatically. The Division of Research Grants has already reported the submission of three grant applications that deal directly with studying the medical use of cannabis -- one on the short-term effects of cannabinoids in HIV patients, a second on ocular cannabinoid effects, and a third on cannabis in the treatment of acute migraine. In addition, the number of requests from non-NIH applicants also may increase substantially. For example, pursuant to a 1991 law that establishes a Therapeutic Research Program within the Massachusetts State Department of Health and Human Services and a 1996 law that makes it legal for patients in the program to have cannabis in their possession, the Massachusetts Department of Public Health has sought assurances that NIDA will supply cannabis for clinical trials on the plant material as a therapeutic modality. NIDA also has received inquiries from the Executive Director of Special Research Programs at the University of California concerning the provision of cannabis for research purposes. This request is associated with a measure that is currently before the California legislature that would establish a California Medical Cannabis Research Center at the University of California. An additional consideration relative to the supply of cannabis is the possibility that investigators may request cannabis cigarettes with either a THC potency of greater than 4% or with varying amounts of other cannabinoids. For example, NIDA has received a request for cigarettes with an 8 % potency. Currently, the highest potency manufactured is 4 %. To obtain the higher potency, NIDA would either have to use more crude material or use special, more costly, growing methods. CURRENT STATUS: NIDA is evaluating its policies related to the Drug Supply Program, in particular the growing and supplying of cannabis, to ensure consistency and uniformity. The National Advisory Council is being requested to assist NIDA through the development of clear guidelines and policies related to this issue. A subcommittee of the Council has met and determined that the questions listed below should be considered by the full Council. Background and the Council subcommittee recommendations are included for each question.
The subcommittee takes note that NIDA over the years has supported research on the clinical pharmacology of cannabis and recommends that NIDA now consider conducting research on the clinical pharmacology of cannabis at varied potencies and with different cannabinoid mixes. Most clinical studies have been conducted using cannabis cigarettes with a potency of 2-4% THC. However, it is anticipated that there will be requests for cannabis cigarettes with a higher potency or with other mixes of cannabinoids. For example, NIDA has received a request for cigarettes with an 8 % potency. The subcommittee notes that very little is known about the clinical pharmacology of this higher potency. Thus, while NIDA research has provided a large body of literature related to the clinical pharmacology of -cannabis, research is still needed to establish the safety of new dosage forms and new formulations. Furthermore, drug interactions with other pharmaceuticals and alcohol have seldom been studied for any of the potencies. The subcommittee feels that it is within NIDA's purview to conduct research to address the clinical pharmacology and safety of cannabis and it recommends that NIDA continue to vigorously conduct this type of research. |
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