Dear MAPS contributors and other interested people,
The summer is now ending and this is the report I promised on the progress that has been made in the effort to determine if MDMA can become a legal medicine. Though there has been absolutely no change in the attitude of the FDA towards human studies (they refuse to permit research, even in terminal patients for whom the theoretical danger of long term functional consequences of MDMA neurotoxicity seems remote, to say the least), there is a growing body of evidence that may turn this situation around. This evidence is primarily coming from studies in primates, partially funded by donations to MAPS. I would like to thank all of you (there are actually only 75 people who are current supporters of MAPS), for helping to develop sorely needed facts to be used to assess the risk of MDMA neurotoxicity. Many people are supportive of the use of MDMA in psychotherapy, but feel that it is hopeless to work with the FDA, and so they refrain from contributing. Those of you that value this effort are few, and are greatly appreciated and needed.
As I see it now, the FDA will succeed in delaying MDMA research in humans until next summer. The questions that they raise about neurotoxicity, while not really relevant to the single oral administration of MDMA in humans under medical supervision, are not yet resolved completely. Two studies, partially funded by MAPS and conducted by Dr. George Ricaurte at Johns Hopkins, are underway. They address the two fundamental questions about MDMA neurotoxicity. When damage occurs, is it permanent or temporary? When MDMA is given in human relevant doses, does any damage occur at all? Preliminary data indicate that when MDMA does cause neurotoxicity, it is temporary, and that when MDMA is given to primates in a single oral dose of 2.5 mg/kg, there is no neurotoxicity anyway. The studies that MAPS has initiated are going to address these matters, and will be concluded in the spring of 1989. Then, the attempt to open the FDA to human studies will begin again.
One of my talents is in spending all of the money that I have. Yesterday, I sent out checks totalling $12,250, mostly for research and some for a health and regulatory affairs consulting firm to help negotiate with the FDA. If you feel moved to contribute, there are more projects that can be funded. However, the main news is that all the necessary pieces in the neurotoxicity puzzle are under construction, and there is basically nothing to do until the new studies are completed.
Today, I move from my home and begin weaving my way to Cambridge, where I start studying at Harvard’s Kennedy School of Government for a Masters in Public Policy. They say, “if you can’t beat ’em, join ’em”and we all know how often They are right. Anyway, I can now be reached at 23A Shaler Lane, Cambridge, Mass 02138. I hope your summer was as special as mine, and that the winter will be stimulating.