MAPS Bulletin Autumn 1990 Vol. 1, No. 3
MAPS has assisted several research groups prepare applications for FDA approval of MDMA research in humans, all of which have been denied. FDA required MDMA’s neurotoxic risk to be clarified in animals before human studies would be permitted. The three critical questions about MDMA neurotoxicity are, 1) does it occur at human relevant doses, 2) If it occurs is it permanent or temporary, and 3) lf if occurs, is it beneficial, harmful, or neutral?
While the risk benefit calculations of the FDA are politically skewed, they are constrained somewhat by data. Millions of dollars invested by the government in MDMA research are beginning to yield a clearer picture of the risks of MDMA. MAPS builds on government funded research by using our limited resources to support small pilot studies examining the effects of human relevant doses, overlooked in most studies which tend to explore the effects of higher doses.
The scientific data tends to support the conclusion that MDMA ncurotoxicity, if it even occurs at average doses, extracts no measurable price when MDMA is used irregularly and in normal amounts. The scientific data, however, cannot yet precisely evaluate the risk to subjects in an MDMA research protocol. What is required for FDA approval is continued support for small pilot studies defining the threshold dose at which MDMA no longer causes neurotoxicity, the rate and extent of regeneration, and functional consequences, if any, of ncurotoxicity. Your contributions to MAPS, however small, make a critical difference in this research.