Pennsylvania is kicking off its medical marijuana research program, announcing that three of the state’s medical schools have received a green light to investigate the potential benefits and risks of using medicinal cannabis to treat health conditions.
In the June 20 announcement, the Pennsylvania Department of Health approved partnerships between Drexel University College of Medicine and Agronomed Biologics LLC, Sidney Kimmel Medical College at Thomas Jefferson University and MLH Explorations LLC, and Penn State College of Medicine and PA Options for Wellness. The Department of Health plans to approve five more partnerships between the state’s colleges and licensed cannabis growers later this summer, WHYY reported.
Pennsylvania’s research program has been more than three years in the making. The governor signed the state’s Medical Marijuana Act into law in April 2016. Built into the law was the promotion of high-quality research, where a licensed cannabis cultivator could seek a “clinical registrant” license to partner with one of the state’s medical schools, called an “academic clinical research center.”
State regulations allow a cannabis business to be licensed as a grower/processor or as a dispensary—not both—but businesses granted clinical registrant licenses may become vertically integrated and sell their products through their own retail channels.
“[The state] provided a mechanism whereby these companies could become these super grower/processor/dispensers, but they had to do so in partnership with a medical school,” Dr. Kent Vrana, chair of Penn State College of Medicine’s Department of Pharmacology, told Cannabis Business Times. “There are nine medical schools in the commonwealth. Eight of the nine chose to go down this path, and we were one of them.”
Late last year, the state scrapped all of the medical marijuana research applications it had received, saying that none of the applicants met the necessary requirements.
Regulators vowed to restart to program in 2019, and once the eight schools were approved as academic clinical research centers, they could choose a licensed clinical registrant as a partner. Penn State chose to form its partnership with PA Options for Wellness.
“We had selected them as our corporate partner about a year ago, and I’ve been working with their president, Tom Trite, to flesh out how our working relationship would work,” Vrana said. “What was most attractive about PA Options for us here at Penn State is that Tom is actually a trained pharmacist, and his former career was managing pharmacy programs for long-term health facilities. So, he gets the medical model.”
Now that the partnership is official, Penn State plans to pursue a series of studies on which forms of medical cannabis and which ratios of CBD and THC are effective treatments for different medical conditions, Vrana said. Pennsylvania has more than 20 qualifying conditions in its medical marijuana program.
“We have tons of these stories where someone has a loved one who smoked pot when they had renal cell cancer and ended up being cured, but we have no controlled experiments, so that’s, I think, the game-changer here,” Vrana said. “[This program] will provide resources to conduct these high-quality, double-blind, placebo-controlled trials, where the pharmacist doesn’t know what’s being given to the patient, the patient doesn’t know what they’re getting, and after two weeks, for instance, they can be evaluated.”
For Agronomed Biologics, the cannabis firm that has partnered with Drexel, this sort of research will improve the overall quality of medicine that can be targeted in efficacy for specific conditions.
“When you look at cannabinoid and terpene profiles, … some work very well for anxiety,” said Agronomed CEO Jon Cohn. “Others can cause anxiety. Some work well for weight loss. Many of it works well as an appetite stimulus and weight gain. So, it’s important that patients are using the right profiles to solve the right problems, or else they will certainly not be causing benefit. … Doing that [research] through evidence-based, double-blind, placebo processes is really the accepted way of doing it and tends to be the most accurate way of doing it.”
Agronomed produces formulations targeted at neuropathy, PTSD and immunotherapy, which are all areas of interest for Drexel, Cohn said. “Drexel can provide us access to resources and very intelligent people that can do the research, and they also can provide equipment that we may not want or be able to afford in all those stages of research, so it seemed to be a win-win.”
Drexel and Agronomed will form a research committee, which will prioritize research studies, Cohn said. Multiple studies will run concurrently, he added, with Agronomed’s dispensary capturing anecdotal evidence from patients, as well as conducting plant-touching research, while Drexel performs the data-driven research.
At Penn State, Vrana plans to focus initial efforts on studying medical cannabis’s impact on pain and cancer, using animal and cell culture models to test which cannabinoids and ratios of cannabinoids are effective in treating the conditions.
Although Pennsylvania regulators legalized the use of smokable medical marijuana (after an initial smoking ban), Penn State will not be working in that space. “I can’t do high-quality research with that material, but we’ll be focused on marijuana extracts,” Vrana said.
Because cannabis remains a Schedule I substance, Penn State will not dispense the extracts to patients, and it will not take possession of any materials from PA Options, Vrana said. Instead, Penn State will work in consultation and collaboration with PA Options, providing them with survey instruments.
“Let’s just use as an example that somebody comes in [to the dispensary and] they’ve been approved for medical marijuana for chronic pain,” Vrana said. “They would come in and take a survey asking, ‘What is the level of pain right now, and what medications are you taking?’ They would get their marijuana extract, go off, and then when they come back to renew their … dispensation—which can only be done once a month—they would come back and take that same survey. The data would be entered into a database, and we would help PA Options monitor that database and mine it to find out what types of marijuana material are effective for pain.”
State law mandates that the medical school must approve the research conducted by the cannabis company, and Penn State’s review board will review PA Options’ protocols to ensure patient safety, Vrana said. PA Options will provide Penn State with financial support over the next 10 years to conduct pre-clinical studies.
“Now, the fly in that ointment is that we’re not taking possession of PA Options’ stuff, so we will get our marijuana from the federal government, which has a contract with the University of Mississippi to grow it for research purposes,” Vrana said. “We will get marijuana from Mississippi through the National Institutes of Health, and then we’ll make our own extracts here using the same protocols as PA Options. We’ll study those extracts, and we’ll do experiments with CBD and THC that we can purchase from licensed vendors that are approved by the NIH. We have to keep a firewall between us and the company because if we were to take possession of their material, we could be considered to violate federal law, so we just aren’t going to do that.”
PA Options is probably still four to six months out from conducting clinical trials, Vrana added, although Penn State has received several calls and emails from patients eager to participate.
But the partnerships between the state’s medical schools and cannabis businesses are a first and important step in the process, Vrana said. Now that Pennsylvania has opened the door to these clinical studies, the research centers can conduct the kind of high-quality research that has been largely off-limits due to cannabis’ Schedule I status.
“With these  states and D.C. that have approved some form of legalized marijuana and the federal decision not to prosecute those states, I think we’ve got a micro-environment that allows us to do research, and now we’ve got the first of the states that’s actually promoting high-quality research,” Vrana said. “So, we’re going to get beyond these stories of someone who did pot and it helped. We know there are … millennia of evidence or suggestions that marijuana could be beneficial, but we have very little high-quality research that proves that. [Now,] we can get beyond stories and start publishing findings.”
Published at Fri, 28 Jun 2019 14:53:00 +0000