Another Independent IRB

For the last several months, another independent Institutional Review Board (IRB) has been reviewing Dr. Michael Mithoefer’s MAPS -sponsored MDMA/PTSD protocol. Today, we submitted our response to another series of questions and a revised protocol and informed consent form. We anticipate hearing from the IRB in several weeks. MAPS had considered forming its own IRB and had written a set of required standard operating procedures and obtained commitments from a group of illustrious people to serve on the MAPS IRB. However, before launching the MAPS IRB, we decided to try one more time with an Independent IRB. So far, this IRB has restored our faith in the IRB review process since the review is being based on the scientific merits of the design.

If MAPS does obtain IRB approval, the final step in the approval process will be for Dr. Mithoefer, the Principal Investigator, to obtain a DEA Schedule I license to handle a total of 3 grams of MDMA for administration to all the subjects in the study (12 subjects will each receive a dose of 125 mgs on two occasions, three to five weeks apart, with another 8 subjects will receive placebo on two occasions, also three to five weeks apart). While DEA has held up Dr. Mithoefer’s application for a Schedule I license for MDMA for over a year, and has previously indicated that it might refuse to approve Dr. Mithoefer’s license on the grounds that it considered the study not to be in the public interest, we have more recently gotten the impression that DEA will indeed approve the license once IRB approval for the protocol has been obtained. A legal analysis submitted to DEA by MAPS President Rick Doblin has been helpful in that it showed that the Controlled Substances Act (CSA) was written by a Congress that was suspicious the DEA would seek to block medical research into Schedule I drugs, which has indeed turned out to be the case. Fortunately, the CSA does not permit the DEA to take the vague category of public interest into account when it reviews applications for Schedule I licenses for FDA-approved research but is restricted to using a much more limited set of criteria relating exclusively to whether the physician can be trusted to administer the drugs to the research subjects and not divert any to non-medical uses.

While nothing can be predicted with certainty, it seems that MAPS’ 17-year struggle to start MDMA psychotherapy research (MAPS was founded in 1986) may finally be successful within the next several months. Time will tell…