PA Trailblazing in Medical Cannabis Research
Medical cannabis passed in PA, in 2016. Pennsylvania is leading the pack in clinical research into marijuana, with a process for researching the therapeutic effects of medical cannabis. Advocates express that combining medical cannabis and in-depth scientific studies of its efficacy for certain ailments, is a huge step. Clinical research will also aid in discovering the proper dosing and combinations of cannabis compounds to bring relief. Research will determine if patients are getting their money’s worth and allow for new treatments for patients who have exhausted all other conventional options. “This is the first time there has been any responsibility taken for improving the science behind medical cannabis,” said Dr. Charles V. Pollack Jr., director of the Lambert Center for the Study of Medical Cannabis and Hemp at Thomas Jefferson University in Philadelphia.
While Pennsylvania may be in the forefront of research, the federal government still views cannabis as a Schedule I drug. This groups it into the same category as harder drugs like heroin and LSD. Marijuana’s negative stigma keeps federal funders leery of funding scientific research into its beneficial effects. Surprisingly, there is a small fraction of funds set aside for such research. The National Institutes of Health split up $28 million among a lengthy list of research studies exploring the effects of cannabis or its components on conditions including Alzheimer’s disease, opioid use disorders, low back pain, sickle cell disease, and adapting to anxiety, depression and stress. The $28 million totaled close to one-tenth of one percent of the $17 billion NIH awarded that year for research projects. The National Institute on Drug Abuse (NIDA) adds that research “suggests that THC and other cannabinoids, may have potential in the treatment of pain, nausea, epilepsy, obesity, wasting disease, addiction, autoimmune disorders, and other conditions.” However, the body of research hasn’t grown to a size large enough for drawing conclusions and winning FDA approval for the use of cannabis in most circumstances. “The FDA requires carefully conducted studies (clinical trials) in hundreds to thousands of human subjects to determine the benefits and risks of a possible medication,” NIDA stated. “So far, researchers haven’t conducted enough large-scale clinical trials that show that the benefits of the marijuana plant (as opposed to its cannabinoid ingredients) outweigh its risks in patients it’s meant to treat.”
In line with every other detail of the Pennsylvania Medical Marijuana Program, rigid requirements limit those doing research to only organizations who meet certain criteria and are licensed. The goal of researchers is to become an approved Academic Clinical Research Center (ACRC). Eligible candidates must be an accredited medical school in Pennsylvania that additionally operates or joins with a Pennsylvania-based, and licensed, acute care hospital. The research institution signs a research contract with a “clinical registrant,” which receives a special permit to operate as a grower/processor with up to six dispensaries. This clinical enrollee will produce the medical cannabis being used for the study and appoint research subjects through coordination with the dispensaries.
Participating patients must have Pennsylvania medical marijuana cards, along with a doctors’ certification stating that they have a qualifying medical condition. The state grants the school a special permit as a “certified ACRC,” allowing them to run clinical research into medical cannabis. Up to eight permits can be awarded statewide. So, how does this system maneuver federal restrictions, including the need for DEA approval of research into Schedule I drugs? They solve these issues by making sure that the academic hospital can review data, but isn’t physically handling the product. The law says that the certified ACRC “will provide medical advice to the approved clinical registrant regarding, among other areas, patient health and safety, medical applications, and dispensing and management of controlled substances.”
Within the health care institutions eligible for applying, news reports note that the University of Pittsburgh School of Medicine, Penn Medicine, Drexel University, and Thomas Jefferson University are among some that are interested in getting permits. “It is important to note that Pennsylvania is the first and only state in the country to institute such a program, and we believe that the research will be of great importance in determining the safety and efficacy of medical cannabis products in treating specific diseases,” the University of Pittsburgh School of Medicine said in a statement. Thomas Jefferson University has long signaled its desire in the field. The Center for Medical Cannabis Education and Research was renamed The Lambert Center for the Study of Medicinal Cannabis and Hemp at Thomas Jefferson University. This was done to honor a $3 million gift from an Australian philanthropist, whose granddaughter found relief from devastating seizures through medical cannabis in 2016. “We see an area in which clinicians are working with patients without ‘the net’ of underlying evidence, and we feel a compulsion to try to fill that gap,” said Lambert director Pollack. “We want to ease patient suffering. We want to educate physicians, nurses, and pharmacists better.” A Philadelphia attorney, specializing in medical cannabis law, adds that medical researchers must sort through the hundreds of different cannabis cannabinoids – or chemical components — to figure out the right combinations that work on a specific medical condition. When an effective combination is found, researchers can turn it into a medical product, apply for patents, and the partner grower/processors could win exclusive licenses to sell that product.
The director of the Pennsylvania Medical Marijuana Program, John Collins, told reporters that “there seems to be a high interest in doing research around pain management and as a replacement for opioids.” Whichever direction researchers choose, supporters hope that Pennsylvania’s leadership will start to bring scientific clarity to an unclear field. “The issue is: A doctor is certifying that a patient can use medical marijuana for treating a specific condition, but that doctor . . . is just sort of authorizing medical marijuana as a treatment,” said Peter Murphy, regulated substances attorney at Eckert Seamans. “Then, currently, it’s left up to the grower-processors to decide what kinds of products they’re going to make. Well, those products might not be the best ones for certain conditions. Having a clinical registrant model, where the science and medicine and cultivation and development of products are together—it kind of closes that gap.”