The entities have partnered under Pennsylvania’s medical cannabis research program, and have already launched surveys to study patient outcomes, with many more studies planned.
Trite testified at the Pennsylvania House and Senate hearings on developing regulations for the state’s medical cannabis program. He then finalized the business plan for his vertically integrated company in 2014 with the goal of supporting anecdotal information surrounding medical cannabis with double-blind studies.
“I think it took them way too long to get to the research portion, but they’re there now and we’re excited to work with others within the industry, too, to provide research,” Trite says. “We … feel it’s a great need, both in Pennsylvania as well as nationally.”
Trite entered discussions with Dr. Kent Vrana, chair of the Penn State College of Medicine’s Department of Pharmacology, in 2015. The university called an “academic clinical research center” under Pennsylvania’s medical cannabis research program, selected PA Options as its “clinical registrant” partner in 2019.
“The thing that attracted me in the beginning to Tom is that he’s a practicing pharmacist—he’s trained at the Philadelphia College of Pharmacy, and he ran a company of long-term care facility pharmacists for many years,” Vrana says. “He’s in this with a medical model. It’s all about the patients [and] seeing that the patients are cared for. Aside from having pharmacists involved at every stage—from production to dispensing to follow-up—he’s also interested in publishing data, whether positive or negative. … They have no control over what we publish. We inform them of what we’re doing, but they don’t control that. But he doesn’t care. If we have data that says something doesn’t work, he wants that to be out. I was always very pleased with that.”
Trite and his team were equally pleased with the researchers at Penn State.
“I can’t say enough about the researchers, Kent and his team,” Trite says. “We were excited to be the one they chose. It was a very stringent selection process with them, and we’re happy to come out on the other side. The researchers are phenomenal that they bring to the table, so I think there will be many great things we can do for a lot of people.”
PA Options opened its first dispensary, Vytal Options, in Lower Paxton Township, in the same building as its headquarters, on June 29, taking a major step toward launching its research partnership with Penn State.
Broadly speaking, the studies will focus on improving patient outcomes and quality of life through the use of medical cannabis, as well as the safe use and administration of products. PA Options will survey its patients to determine how various medical cannabis formulations affect the 23 qualifying conditions in Pennsylvania’s program, and eventually, which formulations perform better for which conditions.
“In addition to outcome management of all 23 of the indications, we’re working on various disease states and scientific, independent review board-approved, double-blind studies,” Trite says. “We’re going to be reporting any negative as well as positive results and looking at drug interactions.”
Penn State is no stranger to how cannabis might interfere with other drugs; earlier this month, Vrana and his colleagues published a paper in Medical Cannabis and Cannabinoids that identified 57 drugs with potential drug-to-drug interactions with cannabinoids.
“Imagine that you’re taking Warfarin and your body has learned to handle it, and … the liver takes control of destroying it at a certain rate,” Vrana says. “Now you take a cannabinoid on board, … without checking with your doc, and it can interfere with the metabolism of that Warfarin because the same enzymes that take care of the Warfarin take care of the cannabinoids. There’s a potential for a bad outcome, … so we want people to know about this. We’ve created this document and we’re in the process of creating patient handouts.”
The Pennsylvania Department of Health has distributed Penn State’s paper to the roughly 2,500 doctors registered with the state’s medical cannabis program, Vrana adds, and he is looking forward to advancing this research through the university’s studies with PA Options.
PA Options has already initiated the outcome study with patient surveys, which were created in collaboration with Penn State and the Pennsylvania Department of Health. The surveys will be available on patients’ smartphones, and Vrana anticipates 100 survey participants per day, although patients must opt in to have their information used in the study.
“In the one case, they’re going to be asking these questions only to help the patient and see if they’re improving on a certain medication,” Vrana says. “And the second thing is to ask the patient to see if we can use that information to inform the broader public, and that’s a well-regulated process in which their identifiers are stripped from the data before it would ever be shared, and they have to give their permission before they’re ever enrolled in that. It’s important to understand that we really abide by the rules and we’re going to protect the patients and their identities at all costs. I don’t know how many people will agree to this, but if they don’t agree, we don’t see their data.”
Data collection will continue indefinitely, with the main goal of helping patients decide if the products they are using are improving the symptoms of their medical condition. Penn State will need 1,000 to 2,000 individuals sharing their information with the university in order to have enough data for the study, Vrana says.
“We have a 10-year relationship with PA Options and we’re in it for the long haul,” he says. “I suspect we’ll probably only start looking at the data in a year, maybe 18 months.”
PA Options and Penn State are also designing double-blind clinical studies that will launch at a later date and will focus on how specific medical cannabis products impact individual medical conditions.
“We’re surveying now, and the surveys are pretty positive,” Trite says. “I think in the outcome study, it will be more tracking and making sure the patients are getting the medication they need. … You want to be able to track the quality of the products that the individuals are [using] and then identify individuals that do not receive the [desired] outcomes and try to find the product that’s better indicated for that individual.”
The company also hopes to launch future studies focused on opiate use.
“We plan on … looking for solutions with opiate reduction, getting individuals off the opiates and on much safer and better relief with medical cannabis, as well as working with [veterans] and mothers and children to help as many people as we possibly can,” Trite says.
Ultimately, Trite wants the research collaboration with Penn State to allow PA Options to provide personalized medicine to patients.
“It’s not going to work for everybody, but I think when we get down to personalized medicine, we’ll be able to help more people by coming up with something that is needed for their body to better receive the medication,” he says.
PA Options is starting to grow its first crop at its cultivation facility and after the first harvest, it will manufacture its own products, including oral and topical formulations. For the time being, the company is sourcing products from other licensed grower/processors in the state.
PA Options plans to open its second dispensary in Lancaster within the next month, and has started work on its third location, which Trite says will be operational this fall.
“Now, we just have to further produce evidence-based medicine and then improve upon that even as we move into the future,” Trite says. “Pennsylvania has a great model.”
“I’m just delighted to have the opportunity to participate in something that’s being translated to the patient—that’s a central focus of what we do,” Vrana adds. “This is a case where what we do is going to enhance the health of the people of the Commonwealth and the world in general.”
