MAPS' top priority regarding medical marijuana research is to continue to support the efforts of Dr. Donald Abrams of UC San Francisco to obtain permission for a study comparing the use of smoked marijuana with that of the FDA-approved orally-administered THC capsule (Marinol) in the treatment of weight loss associated with the AIDS wasting syndrome. We have been working for the last three and a half years to initiate this research. Our effort is the first attempt in over a decade to obtain permission to evaluate scientifically some of the medical risks and benefits of marijuana. We don't intend to give up until all the necessary regulatory approvals for the study have been granted.
Background
After a two year protocol design and review process, Dr. Abrams obtained approval for his study from the FDA, the UC San Francisco Institutional Review Board, the California Research Advisory Panel and the Scientific Advisory Committee of the San Francisco Community Consortium. Nevertheless, he was unable to obtain a legal supply of marijuana. The National Institute on Drug Abuse (NIDA), which has a monopoly on the supply of marijuana that can legally be used in research studies, refused to provide any for his study. (Incidentally, all the psychedelic research studies that have been conducted in the US over the last five years have used drugs from sources other than NIDA, which does not have a monopoly on the supply of those drugs.)
Regardless of its conclusions, the results of Dr. Abrams' study could benefit a substantial number of AIDS patients. Thousands of people with AIDS are already using marijuana because they believe that smoked marijuana is more effective and has fewer side effects than Marinol. Perhaps the study will verify these anecdotal reports. It is also possible the study will demonstrate that marijuana is harmful to the immune systems of the AIDS patients and does not make a positive contribution to their health and longevity. Either way the study turns out, it should be conducted.
Incidentally, if the medical use of marijuana is proven safe and effective, patients and the health care system could save a substantial amount of money over the sums spent on Marinol. Dose for dose, marijuana would be substantially less expensive than Marinol.
A New Grant Application
At a meeting with medical marijuana activists in July 1995, Dr. Alan Leshner, the Director of NIDA, indicated that he would reconsider his refusal to supply marijuana to Dr. Abrams' study if the study were redesigned, submitted to the National Institutes of Health (NIH) as part of a grant application, and approved by the NIH's peer review process. In the fall of 1995, MAPS donated $5,000 ($1,000 of which was a grant from the Drug Policy Foundation) to the San Francisco Community Consortium in order to cover some of the costs incurred in the preparation of the NIH grant application.
Dr. Abrams and his associates are planning to submit their grant application to NIH before the next grant cycle deadline of May 1, 1996. NIH will announce the results of its review of the grant application around October 1996, right in the midst of a heated Presidential election campaign.
The study is being redesigned to take into account the concerns expressed by NIDA and the DEA. The new proposal will be more comprehensive than the initial pilot study that was approved by the FDA and substantially more expensive to conduct. We had hoped to submit the proposal to NIH by its January 1 deadline but the redesign of the study has proven more complicated and comprehensive than anticipated. While none of the final details of the new proposal are finalized, the proposal is taking shape. NIDA criticized the previous design because it was only a pilot study and not a full-scale clinical trial, despite the fact that the results of a pilot study are needed to determine the appropriate size of a full-scale clinical trial. To respond to NIDA's criticism, the NIH proposal will include both an inpatient and an outpatient study. The inpatient study will be designed to gather pilot data and the outpatient study will be designed as a full-scale clinical trial.
The Inpatient Study
The first part of the NIH grant proposal is the inpatient study. The experimental subjects will spend a yet to be determined time living on a hospital ward being fed a standardized diet and being administered measured amounts of their medications on a fixed schedule. The total numbers of subjects are still to be determined as are the number of different experimental groups. The previous design that involved the use of three different doses of marijuana (high, medium or low potency) may be retained.
By using an inpatient study design, all the experimental variables such as diet, amount of marijuana used, exercise, etc. can be controlled. In addition, the DEA's concerns about drug diversion will be resolved because the patients will not be given supplies on a take-home basis. Most importantly, the inpatient study will gather the data required to design a full-scale clinical trial.
The subjects who agree to live in the hospital for the inpatient study are making an enormous sacrifice in the quality of their lives, especially considering that their life span has already been limited by their illness. All attempts will be made to make the hospital ward as warm and enjoyable a place to live as possible.
The Outpatient Study
The second part of the grant application involves an outpatient study in which the subjects will be administered the experimental drugs on a take-home basis. This part of the grant application will study the effects of the test drugs in the manner in which they will actually be used - by people who are not confined to a hospital ward. The outpatient study will involve sufficient subjects to count as a full-scale clinical trial. The inpatient study will begin before the outpatient study. Once the data from the inpatient study has been analyzed, it will be possible to calculate with precision the number of subjects needed in the outpatient study. The number of subjects to be enrolled in the outpatient study will be adjusted, either up or down, depending on the data of the inpatient study.
The NIH Review
There are three possible outcomes of the NIH peer review process. The scientific design of the study could be rejected as flawed, the scientific design of the study could be approved but not funded, or the study could be approved and funded.
If the study design is rejected, NIDA would definitely not provide marijuana for the study. If the study is approved but not funded, it is not clear what NIDA will do. If the study is approved and funded, NIDA would probably provide the marijuana so that the study could proceed.
In order to build support for a decision by NIDA to provide the required marijuana, MAPS and the Marijuana Policy Project, led by Rob Kampia and Chuck Thomas, have conducted an educational campaign directed at the members of NIDA's Drug Abuse Advisory Council and the NIH's Office of AIDS Research's Program Evaluation Working Group. We feel that most of the members of these oversight committees are sympathetic with the need for scientific research to resolve the controversy over the medical use of marijuana. We are asking them to recommend that NIDA provide marijuana to Dr. Abrams' study if is is approved by the NIH peer-review process, whether or not funding is provided.