Yesterday, Peter Gasser, MD, received final approval from the Ethics Committee (Swiss IRB equivalent) for a MAPS-sponsored study to evaluate the safety and efficacy of LSD-assisted psychotherapy for subjects with end-of-life anxiety secondary to life-threatening illness. Dr. Gasser originally submitted his protocol on January 10, 2007, received conditional approval in March, and has been working closely with the Ethics Committee in the meantime to refine the protocol design to address the committee’s concerns. Today, July 13, Dr. Gasser submitted the protocol to SwissMedic, the Swiss equivalent of FDA. Thankfully, like FDA, SwissMedic must respond to the application within 30 days.
Obtaining Ethics Committee approval is the first of three formal regulatory reviews for the protocol to obtain full government approval. After SwissMedic approves the study, Dr. Gasser will submit an application to the BAG (Swiss DEA) for a license to possess and administer the LSD to be used in the study. We were previously informed by a staff member at the BAG that its review process should take about a week, so we are still planning to begin the study by the Fall of 2007.