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Letter from MAPS President, Rick DoblinPatience, persistence and passion. Recent developments regarding MAPS' research agenda have required as much of these qualities as I can muster. In July 1998, the third draft of the protocol for the MAPS-sponsored MDMA/breast cancer patient safety study was submitted to the FDA by Dr. Charles Grob, MD, Harbor-UCLA Medical Center. The study as currently designed seeks to explore the safety of the use of MDMA-assisted psychotherapy in breast cancer patients. After eight months, we are still waiting for the FDA's comments. The changes suggested by the FDA to the two previous drafts of the protocol (the initial draft was submitted two years ago) have all been incorporated into this third draft. We expect that the FDA has yet more concerns, but won't know how to respond until we receive their comments. Sometimes, it seems as if the FDA would prefer for us to just abandon the effort to conduct MDMA psychotherapy research in the United States. MAPS will not do so, however, in part because of reports like the one on page 56, from a daughter who shared MDMA with her cancer-stricken father to assist him in his dying process.Recent research on MDMA neurotoxicity will be discussed in detail in an upcoming issue of the MAPS Bulletin. Data from these studies are actually helpful in making the case that there is virtually no risk of clinically significant long-term serotonin-related negative consequences from the use of one or several doses of MDMA administered in a psychotherapeutic context. In a major effort, MAPS is sponsoring a scientific conference on clinical research with MDMA to take place in Israel, August 30 to September 1, 1999. MAPS plans bring together MDMA researchers from the US, Switzerland, Spain, and England, all the countries in which regulatory authorities have granted researchers permission to administer MDMA to human subjects. The conference will provide the latest information about MDMA to the Israeli psychiatrists at Ben-Gurion University of the Negev who are working with MAPS to design and obtain approval for a study of the use of MDMA in the treatment of post-traumatic stress disorder. The conference will also facilitate collaboration between teams of MDMA researchers around the world. Obtaining approval for MAPS-sponsored medical marijuana research has also been difficult. As reported in the last Bulletin, the National Institutes of Health (NIH) rejected for the second time the grant application of Dr. Ethan Russo, U. of Montana, for a study of the use of smoked marijuana in people whose migraines are not successfully treated by currently available medicines. The NIH letter explaining the rationale for its decision arrived well after the news of the rejection of the grant. The NIH reviewers focused in large part on an issue that cannot be resolved and that has nothing to do with the scientific merit of the protocol design, the supposed need for preliminary data to supplement extensive historical and anecdotal reports. It is difficult to imagine that the NIH reviewers didn't realize that it is impossible to obtain permission to conduct preliminary studies, or didnšt know that the NIH Expert Committee on the Medical Uses of Marijuana recommended full-scale trials. Despite the Clinton Administration rhetoric in favor of medical marijuana research, the reality is continued obstructionism. In a victory for the opponents of medical marijuana, Dr. Russo has decided that it is futile to reapply to NIH a third time. The Clinton Administration position that the controversy over the medical use of marijuana should be resolved through scientific research rather than at the ballot box will remain dishonest and deceptive until good-faith efforts to conduct research, such as attempted by Dr. Russo and supported by MAPS, are permitted to proceed. Despite the struggles MAPS is engaged in, our strategy remains one of patience and persistence grounded in passion. We draw strength from the original research that MAPS can conduct, such as this issue's feature article on the follow-up to Dr. Janiger's pioneering LSD research. The MAPS staff realize that we are privileged to be able to work on behalf of the MAPS membership on issues about which we care passionately. Rick Doblin, MAPS President
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