MAR 30, 2018

Pennsylvania State Medical Marijuana Program Paves the Way for Innovative Clinical Research Partnerships

WRITTEN BY: Mauri Brueggeman

The availability of legal medicinal cannabis is growing across the United States; to this day there are only two states, Idaho and Kansas, where the law does not recognize medical cannabis use in some way according to the Marijuana Policy Project.  States are creating meaningful Medical Marijuana Programs (MMPs) which shows great progress for patients to remain in the area of their support network and access potentially therapeutic options for their conditions.  There is still the challenge of the federal government’s Schedule I classification of marijuana (listed as a dangerous and addictive drug with no medical benefits), which greatly affects research support.  Pennsylvania (PA) might have a solution and is the first state to include legal language regarding support for strategic partnerships between accredited Medical Schools in PA and dispensaries or growers in PA. 

The state of PA began issuing medical marijuana dispensary and grower approvals as part of their MMP earlier this year.  In addition to these, the MMP in PA had the foresight to value the need for research surrounding the use, efficiency, and application of medical marijuana as part of patient care.  Title 28, Part IX, Chapter 1210 of the Rules and Regulations of the PA Department of Health was released March 17, 2018 and outlines the regulations of medical marijuana and clinical partnerships with academic research institutions to further scientific and medical advancement of medical marijuana use. 

“28 PA. Code CH. 1210” for short is a supplement to the MMP for the state and provides temporary regulations for these partnerships until March 2020.  Growers and dispensaries are considered “clinical registrants” and academic clinical research centers (“ACRCs”) can apply to enter into partnerships and be approved by the PA Department of Health. ACRCs must be accredited Medical or Osteopathic Schools and there are already multiple medical schools interested include the University of Pittsburg School of Medicine.  28 PA. Code CH. 1210 indicates that approved ACRCs and clinical registrants will be listed and required to document Institutional Review Board (IRB) approval for proposed research.  It is not clear if the Department of Health in PA will maintain its own IRB along with that of the academic institution approved as an ACRC.  These partnerships are novel because the state government is outlining the regulations for allowable sale or exchange of cannabis seeds, immature or mature plants, cannabis products between approved clinical registrants and the academic institution for research purposes.  The reach and capacity for clinical research at a Medical School goes far beyond the capacity of individual approved medical marijuana providers or groups involved with production/dispensaries.  The infrastructure is already present including the recruitment, planning, implementing and evaluating support necessary to see clinical research through to fruition.

From an educator’s perspective, right now medical students, residents, or other medical providers (Nurse Practitioners, Physician Assistants, etc.) get little to no education or information about the benefits of cannabis as part of their medical curriculums.  Current practitioners don’t see information about medical cannabis unless they seek it out.  Articles like that in the Journal for Drug and Alcohol Dependence indicate that physicians in training do not have the preparation to recommend medical marijuana.  These partnerships not only bridge a gap in potential research but also in the potential for infusing information quickly into medical education in PA; whereby that information can get disseminated as those students graduate and become residents, spreading new knowledge and research before it may get into peer-reviewed publications.   There are already vast amounts of information packed into these programs but even a little scientific information can go an incredibly long way.  Learning about the endocannabinoid system and how medical marijuana and compounds of cannabis work on the cellular level is eye opening and incredibly valuable to understanding the process and sensation of pain in the body.   Hopefully more states can support and promote partnerships like this.  There are rumors of other states that have considered similar language and planning as part of their MMP but have not been able to put it all together to implement.  Some states with some amount of legalization of cannabis (medical or recreational) have been able to create opportunities for research but it is in the shadows.  University of South Florida school of Pharmacy is one and the University of California-San Diego created the Center for Medicinal Cannabis Research which has been in place for almost two decades.

Sources: Pennsylvania Medical Marijuana Program, 28 PA.CodeCH1210, Marijuana Policy Projecthttps://www.mpp.org/, Journal for Drug and Alcohol Dependence, Triblive, Center for Medicinal Cannabis Research,