On January 24, 2013, MAPS Executive Director Rick Doblin, Ph.D., sent an email to the U.S. Department of Health and Human Services reminding the agency that three full months had passed since we resubmitted the protocol for our Food and Drug Administration (FDA) and Institutional Review Board (IRB)-approved study of marijuana for symptoms of PTSD in 50 U.S. veterans with chronic, treatment-resistant PTSD. “We remain eager to engage in a dialogue with the PHS reviewers regarding methodological issues,” Doblin writes “This delay is itself an obstruction of medical marijuana drug development research.”
Subject: 3 Months for PHS Marijuana/PTSD Protocol Review, Chicago Tribune column
Date: January 24, 2014
From: Rick Doblin, MAPS
To: Sarah Wattenberg, HHS
Sarah,
Today completes the third month since Oct. 24, 2013, when we submitted to you our FDA and IRB-approved protocol for PHS review. We remain eager to engage in a dialogue with the PHS reviewers regarding methodological issues. This delay is itself an obstruction of medical marijuana drug development research.
In our letter of Oct. 24, 2013, MAPS also requested that HHS end the PHS protocol review process for privately-funded medical marijuana drug development studies. PHS review is designed for evaluating grant applications for government funding of basic science. PHS review is not appropriate for privately-funded FDA drug development studies designed to meet FDA standards but not to gather basic science information. The PHS review exists only because of NIDA’s DEA-protected monopoly. Rather than the PHS review, NIDA should sell its marijuana at cost to all sponsors of research approved by FDA, DEA, IRB and state authorities. Those agencies already regulate privately-funded research with all other Schedule 1 drugs, without PHS involvement.
As you may have noticed, a column in yesterday’s Chicago Tribune by Steve Chapman, a member of the Tribune‘s editorial board, called on President Obama to end the PHS medical marijuana protocol review process. Since it hasn’t ended yet, I look forward to working with you to find a way to start this much-needed study.
sincerely,
Rick
