There are several important errors in the Nature editorial, 'Ecstasy after-effects.' The statement that there are three MDMA/PTSD studies in Europe is false. There are none. In Madrid, there had been one MAPS-sponsored dose-response study of the use of MDMA-assisted psychotherapy in women survivors of sexual assault with chronic, treatment-resistant PTSD. More than a year ago, however, after some favorable publicity about the study in the Spanish media, the Madrid Anti-Drug Authority managed to intimidate the hospital where the study was taking place to shut down the study in its early stages.

Since the Spanish Ministry of Health has not withdrawn permission, we have been struggling to obtain permission to resume the study. Our efforts have so far not been successful, a failure to which Dr. Ricaurte contributed. One week after his paper in Science was published, he spoke in Madrid at the invitation of the Spanish Anti-Drug Authority (National Plan about Drugs - Plan Nacional sobre Drogas) about the risks that MDMA could cause dopaminergic neurotoxicity. During Summer 2003, Dr. Ricaurte visited Spain several times to speak at conferences and repeated his warnings about MDMA and dopaminergic neurotoxicity well after he had failed to replicate his original, now-retracted results. MAPS has obtained Spanish media articles quoting Dr. Ricaurte to this effect.

The Nature editorial also claims that lack of funding is holding up US MDMA/PTSD research. That is also false. MAPS has enough funding to start the study, though we do need to raise some additional sums, and FDA has issued an IND. However, we have had a very difficult time obtaining IRB approval, again due in part to Dr. McCann and Ricaurte's now-retracted research and Dr. McCann's communications with one IRB that initially approved the study but then revoked approval. We expect that we will obtain IRB approval from a new IRB within a few weeks, though this remains to be seen.

DEA has also resisted for over a year issuing a Schedule I license to the PI, even going so far as to say it might refuse to issue the license because DEA felt the study wasn't in the public interest. In response, I've sent a legal analysis of the Controlled Substances Act to DEA. Fortunately, for research ers with protocols approved by the FDA, DEA is explicitly limited to using specified criteria that focus on diversion control, with the vague 'public interest' not among them. I've since heard from DEA that it is likely to approve the Schedule I license after IRB approval has been obtained.