MAPS Bulletin Autumn 1994 Vol. 05, No. 2 Building Towards Clinical Trials
Water Pipe and Vaporization Study
The $25,000 MAPS/California NORML marijuana smoke filtration study is well underway. Marijuana smoke from three different water pipes, a prototype of a hot-air vaporizer, a specially-designed filtered cigarette and unfiltered marijuana are all being evaluated by one of the nation’s premier smoke analysis laboratories. MAPS has already made the initial payment of $9,000 as well as a second payment of $8,000 which was due at the midpoint of the six-month experiment. Final results are expected by Spring, 1995. This study is part of a larger effort to test the safety and efficacy of smoked and vaporized marijuana in the treatment of a variety of clinical indications. A grant application for an expanded analysis of the most effective filtration devices has been submitted to the Drug Policy Foundation. AIDS Wasting Syndrome Study
A substantial amount of MAPS’ staff time and effort has been spent in an effort to secure governmental approval for Dr. Donald Abrams’ study designed to compare the use of smoked marijuana versus the oral THC capsule in the treatment of weight loss associated with the AIDS wasting syndrome. If and when it begins, this study will become the first experiment in over a decade to evaluate the clinical use of marijuana in human subjects. The last MAPS newsletter contained an article reporting in substantial detail on MAPS’ efforts in support of Dr. Abrams’ study. In that article, the various regulatory roadblocks preventing the initiation of the study were detailed and a series of possible strategies to overcome those obstacles were outlined. Shortly after the newsletter was mailed out, however, a new and totally unexpected development took place.
The last MAPS newsletter reported that the main problem preventing the study from going forward was Dr. Abrams’ difficulty in obtaining an approved source of marijuana for the study. Attempts to import marijuana from a firm in the Netherlands which had legal permission to grow it had been rejected by the Drug Enforcement Administration (DEA). Since the only legal domestic source of marijuana was the National Institute on Drug Abuse (NIDA), and MAPS had previously been told that it did not have the higher potencies of marijuana that the FDA required us to use in the experiment, we were temporarily stymied. Alternative options considered were to continue to seek a Permit to Import, to try to raise funds to contract privately with NIDA’s marijuana grower at the University of Mississippi, to try to used confiscated supplies, or to try to start a non- profit domestic marijuana growing operation. Unfortunately, non of these options seemed likely to succeed.
Fortuitously, a new option entered the equation when we learned that NIDA does have very limited but sufficient quantities of higher potency marijuana. This higher potency marijuana had been grown at NIDA’s marijuana farm for the first time during the 1993 harvest, and was sitting on a shelf in a warehouse with no competing requests for its use. Though the quantities NIDA had in stock were relatively small and the potency wasn’t quite as high as the variety which MAPS had tried to import (NIDA’s supply was 7.57% THC while we wanted to import marijuana with 10% THC), NIDA’s marijuana was more than sufficient for Dr. Abrams’ pilot study.
In August,1994, after it became clear that domestic supplies were indeed available, Dr. Abrams made a formal request to NIDA for the marijuana necessary for his study. We assumed that since FDA had approved the study, NIDA’s agreement to donate its marijuana would naturally and quickly follow. It seemed unthinkable that the Administration could justify refusing to reschedule marijuana because of a lack of scientific evidence, and at the same time refuse to permit research. Hope for easy access to NIDA’s marijuana supply proved to be wishful thinking. Since obtaining a supply of marijuana assures that the study will take place, opposition to this research effort has intensified. As a result, MAPS sought help in trying to influence NIDA’s decisionmaking process. Support for Dr. Abrams’ protocol has come from Congressman Barney Frank, Congresswoman Nancy Pelosi, the Physicians Association for AIDS Care (the nation’s oldest and largest association of physicians interested in AIDS research and treatment), the Federation of American Scientists, NORML, the Drug Policy Foundation, and numerous policy analysts, activists, patients, and physicians. The main arguments we are making are that the controversy over the medical use of marijuana should be decided through scientific research, and the medical needs of patients should not be sacrificed to the War on Drugs.
Due to the controversial nature of this issue, the decision about access to NIDA’s marijuana will be made by Dr. Philip Lee, the Assistant Secretary of Health. Participating in the decision are representatives of the White House Office of National Drug Control Strategy, DEA, FDA, NIDA, the National Institutes on Health, and a few Senators and Representatives who have the courage of their convictions. A decision is expected very shortly. MAPS will keep you informed as to the latest developments.