Ethos Cannabis and the Sidney Kimmel Medical College at Thomas Jefferson University have launched their first studies under Pennsylvania’s medical cannabis research program.
Pennsylvania’s 2016 medical cannabis law allows medical cannabis operators to seek “clinical registrant” licenses to partner with one of the state’s medical schools, called “academic clinical research centers,” to orchestrate patient-facing clinical studies into the benefits of medical cannabis.
“The medical schools cannot physically touch the plant, but they are interested in doing research,” Ethos President of Pennsylvania and CFO David Clapper told Cannabis Business Times. “They’re really interested in doing research, but to do it, they have to partner with a private group like us that can operate under state cannabis laws in the absence of federal regulation.”
Universities like Jefferson have historically had a difficult time conducting research on medical cannabis, not only for fear of losing their federal funding due to the plant’s Schedule-I status, but also because they lack access to patients and they are unable to identify exactly what the patients are taking.
“They’ve tried to do observational-type research over the years, but one of the biggest challenges is, ‘What exactly are the patients taking?’” Clapper said. “People don’t always remember to bring the medical marijuana bottle or vape labels with them to appointments with their physicians. Even if they know what they’re taking, they often don’t know exactly what is in medical marijuana that they’re using. … It’s been very difficult for Jefferson to do much in the way of real research, where they feel comfortable that they’re getting appropriate information.”
“We can do clinical research with patients that we can work with through their connection with Ethos and the Pennsylvania program,” added Dr. Brooke Worster, a physician in Jefferson University’s Sidney Kimmel Medical College. “It sidesteps that ever-challenging federal regulation whereby an academic medical center that gets federal funding would have to jump through all the hoops, with me having a Schedule I license … [and] getting product only from the University of Mississippi. … It gives us a little more flexibility … to understand what’s helpful, what’s tolerated [and] what adverse effects people are having, with a broad range of conditions and products.”
Under Pennsylvania’s research program, academic teaching hospitals had to apply for licenses first, demonstrating that they had identified a clinical registrant and had a research agreement in place.
“The way the program is set up is to require an ongoing research agreement with the hospital, in order to maintain your license,” Clapper said. “It’s a good program in that it keeps groups like us focused on the research.”
Ethos is one of seven clinical registrants currently licensed by the state to grow, process and dispense medical cannabis in partnership with an academic clinical research center, and the company is funding Jefferson’s research on the dispensary’s patients.
“I think Ethos has always had … an actual, real dedication to the research aspect of cannabis, not just doing it to get them the license,” Worster said. “They made a good partner because they really did have a lot of the same interests as we do, as far as, let’s get more data and more knowledge about this because it’s helpful for us, for our patients, for our caregivers [and] for disease management. … I think that’s what made them a good partner from the start.”
Roughly 300 of Ethos’ patients have enrolled in the first observational research study with Jefferson, which will track which products patients are taking, why they are taking them and specific dosage information. Patients are surveyed regularly for one calendar year to provide insight into how the products are affecting them and their medical condition.
“Just by studying the population here, we’ll start seeing trends that will help us distinguish the signal from the noise on, what is the low-hanging fruit?” Worster said. “What are the things where this seems to be very well tolerated and very helpful?”
Ethos and Jefferson are also considering future studies on opioid use.
“Jefferson has seen anecdotal information that suggests if you pair opiates with medical marijuana, you may be able to lower the amount of opiates used by patients and still get the same level of treatment for the condition,” Clapper said. “Jefferson would like to study patients that are using opiates for specific conditions, pair that with medical marijuana, and see what the results are compared to patients who are using only opiates to treat the condition.”
Another potential study would focus on how medical cannabis affects gastrointestinal cancer symptoms, he added.
“Jefferson is seeing what appears to be a positive correlation between people who are using medical marijuana and their ability to withstand chemo treatments for a longer period of time, and that’s something that can be game-changing for GI cancer,” Clapper said. “What they’ve seen anecdotally is that people who are using medical marijuana to treat their cancer and chemo symptoms are able to maintain a better appetite and positive outlook which is necessary for withstanding extensive chemo treatments.”
The Ethos team will work closely with Jefferson to develop new product formulations that align with the university’s research goals.
“We are talking about doing different studies with a transdermal patch or a metered dose inhaler, products that are out there in some markets, but that haven’t gotten a lot of traction. These types of products may lead to alternative methods for using medical marijuana,” Clapper said. “We can use Jefferson’s research information to help create different products or the right delivery mechanism.”
Through Ethos’ participation in Pennsylvania’s research program, Clapper hopes that medical cannabis can eventually become an accepted part of healthcare.
“People are using medical marijuana to treat many different conditions and symptoms, and a majority of states have passed medical marijuana laws, but there are still a lot of doctors who don’t feel like it’s an appropriate part of healthcare,” he said. “How do you change that? … You start to change it when reputable medical schools like Jefferson perform research and publish the results.”
The research conducted through the program must be published, and every study must be approved through the Pennsylvania Department of Health, which provides a timeline for reporting.
“Marijuana’s not going away; more and more of our patients are turning to it, and we don’t have anywhere near the level of sophisticated data about it that we do lots of other pharmacotherapies,” Worster said. “So, it’s a very interesting, much-needed role that Jefferson’s research machine can play here. I don’t want to say it’s simple, but from our perspective, if we can find the means and the partnership and the interest to pursue needed research, then it’s kind of a no-brainer.”
Published at Wed, 27 May 2020 13:56:00 +0000