A Pennsylvania judge has halted the state's new medical marijuana research program. The injunction, announced on May 22, comes just a week after Pennsylvania Gov. Tom Wolf announced that Penn’s medical school would become one of eight university institutions in Pennsylvania selected to be part of the state's new initiative.
As part of the program, the selected medical schools would design research studies for marijuana companies, who would then collect data from patients using their marijuana products.
Penn Medicine was set to team up with PalliaTech, a cannabis producer in Massachusetts, to conduct its research.
A group of 11 cannabis growers and dispensaries put a temporary stop to the program when they contested it in court. Now, Pennsylvania's Department of Health is no longer allowed to hand out additional licenses to companies seeking to pair with medical schools while the program's regulations are under legal review.
Although Penn Medicine and other medical schools are able to keep their permits, research is dependent on the marijuana companies, and no company has yet received its license, including PalliaTech.
Judith Cassel, a lawyer for the firm representing this group, said that part of the concern over the program comes from a lack of proper vetting for companies conducting research.
Cassel said that unlike other marijuana companies, entities labeled “Clinical Registrants” by Chapter 20 of Pennsylvania’s medical marijuana act would not have to obtain a grower/processor or dispensary permit to sell their cannabis products. Instead, they would only need to produce a contract with a medical school to conduct research.
"They created these super-permits that are just big commercial entities that haven’t gone through the vetting process that are going to be automatically rubber-stamped and put into action to sell in the commercial market," Cassel said. "It isn’t what the act intended.”
PalliaTech, for example, was eliminated in the first round of applications for grower permits in Pennsylvania last year and placed 105th in a group of 164 applicants. Under this program, however, PalliaTech would still be permitted to conduct medical marijuana research despite its placement.
Cassel also said that one of the questions is whether the research is unbiased given that registrants like PalliaTech would be trying to sell the product they were researching. Going forward, Cassel said that the program should either be adjusted so that registrants “would be growing and dispensing product purely and exclusively for research” or so that commercial registrants would have to go through a competitive vetting process.
“Then you can assure Pennsylvanians that the research results are at least being conducted by the best of the best in the state,” Cassel said.
Researchers have also raised concerns about the quality of data that could come from the program.
“It sounds like the engagement between Penn and those growers/dispensers within Pennsylvania is going to lead to research that is primarily observational in nature,” said Penn Medicine Psychology professor Marcel Bonn-Miller. “That research is important but it’s also limiting, meaning what’s really needed in the field of cannabinoid research is clinical trials.”
Observational studies, unlike clinical trials, are not randomized or controlled. Bonn-Miller, who currently investigates the effects of cannabinoids in relation to PTSD, said that such studies allow a company to track the effectiveness of a product at a much lower cost than more rigorous clinical trials.
While Bonn-Miller said that “cheap observational studies” can allow for “quick, fast reward,” he also noted that the lack of a controlled environment can lead to bias in the data that patients report.
“There’s so much hype and expectation around cannabis right now that everybody thinks it’s going to work for everything,” Bonn-Miller said. “The problem is that with such high expectations you have a lot of individuals — well I’ll say it this way — you have a high placebo response.”
Johns Hopkins University Psychiatry professor Ryan Vandrey, who investigates the behavioral pharmacology of cannabis, said that a lot more changes need to be made for cannabis research to advance.
In addition to stating the need for better standards for the manufacturing and testing of cannabis products, Vandrey said that low funding and extensive regulations pose barriers to cannabis research.
“There are a number of hurdles here,” Vandrey said. “They’re not insurmountable but it takes a lot of time and a lot of patience and a lot of approvals to be able to do the work that we do. “
“At the end of the day, a lot more needs to be done in the context of cannabis research,” Vandrey added.