On June 18th, after a five month review process, the National Institute of Drug Abuse-Public Health Service (NIDA-PHS) finally responded to our revised vaporizer research protocol, submitted for review January 16, 2008. The submission included three supportive letters from peer-reviewers, confirming the scientific merit of the study and urging NIDA-PHS to approve it. By responding, NIDA/PHS avoided MAPS filing another lawsuit for unreasonable delay, which wed intended to file in the middle of August.
MAPS has still been waiting two years and nine months for NIDA/PHS to respond to our September 2005 reply (PDF) to their rejection of our previous vaporizer protocol (PDF), which we initially submitted in June 2003, after which it took them more than two years to evaluate! We submitted the revised protocol in January 2008 to see if that might motivate NIDA to respond, which it has.
According to Rick, The review is filled with issues designed to delay and exhaust us, that have little importance to the safety or relevance of the intended research, but I don’t think it will deter us for too long. We’ll respond thoroughly and quickly before the end of July, and then wait yet again for a reply. Now that NIDA/PHS are familiar with the issues and have articulated their concerns, their response to our comments should be faster. We’re already making progress in that the strategy of delay has been overcome and a review was issued.
If this situation werent so genuinely tragic for all the sick people who might benefit from this research, then it would simply appear ridiculous. All MAPS is requesting to do is purchase ten grams of marijuana–something virtually any high school student in the US could obtain–so that we can move forward with a study of a non-smoking delivery system for marijuana that might benefit people suffering from a wide range of debilitating, difficult-to-treat illnesses.
The FDA has thirty days to review complicated human protocols. With NIDA/PHSs dysfunctional review process, they have provided us with powerful evidence for why we need to break the NIDA monopoly on the supply of marijuana that can be used in research, said Doblin.
MAPS has been waiting since February 12, 2007 for the DEA to issue a final ruling in response to DEA Administrative Law Judge Bittners recommendation (PDF) that the NIDA monopoly on the production of marijuana legal for research be ended, and that Professor Lyle Craker be issued a DEA license for a MAPS-sponsored medical marijuana production facility.
