Marijuana for PTSD Protocol Resubmitted to HHS; Researchers Await Response

On October 24, 2013, MAPS resubmitted to the U.S. Department of Health and Human Services 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. Currently, the National Institute on Drug Abuse holds a monopoly on the supply of marijuana for research in the U.S. Under current federal policies, reviewers from the Public Health Service (PHS, a division of the Department of Health and Human Services/HHS) must approve all privately funded research seeking to use NIDA marijuana. The FDA approved the protocol in April 2011, but HHS reviewers unanimously rejected the protocol in September 2011, preventing the study from going forward. At the time of the HHS rejection, the study had not yet been approved by an IRB.

In October 2012, the IRB at the University of Arizona approved the study protocol. The IRB accepted all the core elements of our design, added several safety measures and procedures, and rejected HHS’ critiques of the protocol design. We are requesting that HHS agree to sell MAPS the marijuana needed for the study, as well as to abandon the PHS review process entirely, which exists only for marijuana and not for research with any other drug. MAPS is also working with other groups on a Congressional Sign-On letter to HHS Secretary Kathleen Sebelius urging her to eliminate the PHS review and require NIDA to sell marijuana to sponsors of all protocols that obtain approval from FDA, IRB, DEA and relevant state authorities.

View the cover letter to HHS…