108th Congress

“Marijuana and Medicine: The Need for a Science -Based Approach” – hearing before the House Government Reform Subcommittee on Criminal Justice, Drug Policy and Human Resources (Representative Mark Souder [R-IN], Chairman)

April 1, 2004

Witnesses:

• Dr. Nora Volkow, Director, NIDA. NIH
• Dr. Robert Meyer, Director, Office of Drug Evaluation II, Center for Drug Evaluation and Research, FDA
• Ms. Patricia Good, Chief of Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration

The House Government Reform Subcommittee on Criminal Justice, Drug Policy and Human Resources (Representative Mark Souder [R-IN], Chairman) held a hearing to examine the use of marijuana for “medical” purposes. In attendance were Chairman Souder, Ranking Member Elijah Cummings (D-MD), Delegate Eleanor Holmes Norton (D- DC), Representatives Linda T. Sanchez (D-CA), and John R. Carter (R-TX).

The Government witnesses testified on the first panel. Dr. Volkow presented testimony on the progress that NIDA has made over the past 15 years to inform the public about marijuana and its health consequences. Marijuana has been and continues to be the most widely used illegal drug in this country. It is not a benign drug and is an addictive substance that has adverse health and behavioral consequences. Since 1995, there has been a 164 percent increase in emergency room visits involving marijuana. Dr. Volkow reported that marijuana disrupts memory, attention, judgment, and other cognitive functions. It can impair motor coordination, time perception and balance, and is likely to contribute significantly to motor vehicle accidents. Marijuana can affect almost every organ and system in the body, including the immune system, the heart and the lungs. Smoked marijuana has many carcinogenic chemicals and can increase the likelihood of some cancers. Marijuana itself is not just a single drug, it contains more than 400 chemicals. Tetrahydrocannabinol, or THC, is a primary ingredient in marijuana that causes an intoxicating effect, or “high.” Dr. Volkow said that while researchers were investigating why marijuana is abused and how it affects the brain, they discovered a new neuro-transmitter system. They found the brain has specific sites where marijuana has an effect called cannabinoid receptors. Many of these receptors are found in the brain areas related to pleasure, motivation, memory and movement coordination. Recently, a second type of cannabinoid receptor was discovered, which is outside the brain, and is involved in immune function and in pain perception. The discovery of these cannabinoid receptor systems is now allowing scientists and pharmaceutical companies to develop some very useful medications not just for drug abuse, but for a wide variety of medical conditions, including chronic pain, obesity, smoking and alcoholism, among others. Both the NIH and IOM maintain that further research into the potential medical uses of marijuana is justified. NIH has been open to receiving research proposals on this topic. One current NIH study is looking at the effects of oral THC and smoke marijuana on appetite, weight gain, and other behavioral and performance measures on HIV-infected patients. In order to maximize research opportunities, HHS created a mechanism to provide research-grade marijuana on a reimbursable basis, to non-federally-funded researchers. Currently, there are 17 protocols from a California funded research center that have been approved. The protocols cover a range of medical conditions including pain, spasticity, nausea and HIV infections. Dr. Volkow said that these represent a substantial increase in scientifically valid research studies involving marijuana. This research, coupled with the recent discovery of the cannabinoid system and the tremendous science advances that have followed, are leading NIDA to discover a wealth of new opportunities for the development of useful non-addictive cannabinoid- based medications, for a variety of health conditions.

Dr. Meyer informed the Subcommittee about the FDA drug approval process. Dr. Meyer said that botanical marijuana is not approved for any indication in the United States. Pursuant to the Food, Drug and Cosmetic Act, FDA is responsible for the approval and marketing of drugs for medical use, including controlled substances. The DEA is the lead Federal agency responsible for regulating controlled substances and enforcing the Controlled Substances Act (CSA). The CSA separates controlled substances into five schedules depending upon their approved medical use and abuse potential. Schedule one controls substances such as marijuana or those deemed not to have any legitimate medical use, as well as a high potential for abuse. The criminal penalties related to Schedule One controlled substances are far greater under the CSA than those available under the Food, Drug and Cosmetic Act for the distribution of an unapproved drug. The FDA regulates marijuana when it is being investigated for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or animals. Much of that research is focused currently on smoked marijuana, Dr. Meyer said. However, due to the inherent toxicity of the smoking, it is likely that any future approvals would not be of a smoked botanical marijuana. To date, FDA has approved two drugs, Marinol and Cesamet, for therapeutic use in the U.S., both of which contain active ingredients related to those present in botanical marijuana. Dr. Meyer stated FDA will continue to be receptive to sound scientifically based research into medical uses of botanical marijuana and its derivative cannabinoids. Ms. Good testified about the process of applying for a registration under the CSA to grow marijuana for scientific research. In the United States, anyone who wishes to cultivate marijuana to supply scientific requirements would have to obtain a bulk manufacturer registration from the Drug Enforcement Administration. Ms. Good said that the DEA will carefully consider any application for registration of the bulk manufacturer of marijuana consistent with the relevant statutory criteria.

The second panel consisted of witnesses addressing recent state laws in Oregon and California that legalize marijuana for medical purposes and a California physician using marijuana to treat ADD. One of the witnesses was Dr. Robert Dupont, a former NIDA Director now with the Institute for Behavior and Health, Inc., who testified about the hazards of labeling smoked marijuana as a medicine.