The Pennsylvania Department of Health on Thursday announced that it had approved three companies to grow medical marijuana for research in partnership with medical schools at Drexel, Thomas Jefferson, and Penn State in Hershey, Pa.
“This research is essential to providing physicians with more evidence-based research to make clinical decisions for their patients,” Pennsylvania Secretary of Health Rachel Levine said in a news release. "It is the cornerstone of our program and the key to our clinically-based, patient-focused program for those suffering with cancer, PTSD, and other serious medical conditions.”
The research program comes nearly two years into Pennsylvania’s medical-marijuana program, which has 1,140 of the state’s 51,000 physicians approved to administer cannabis to the 106,000 residents who have registered to use it to treat conditions such as ALS, autism, and cancer.
The three research-partnership approvals followed unexpected delays in the program, touted by state officials as a feature that set Pennsylvania’s legalization of medical marijuana apart from other states.
First, the state had to amend the 2016 medical-marijuana law to get around a lawsuit that challenged the constitutionality of the original design of the research program, which allowed medical schools to pick their growers. Then, in December, regulators rejected all eight applications in the first round of applications, saying they were incomplete and riddled with mistakes.
Among those handed rejections Thursday were marijuana growers allied with Temple, Philadelphia College of Osteopathic Medicine, and the University of Pennsylvania for permits that also allow growers to open six dispensaries. Additional rejections went to growers affiliated with the University of Pittsburgh and Lake Erie College of Osteopathic Medicine, in Erie.
A third application round will occur, but no timeline has been set, a Health Department spokesperson said.
Under the research program, the health systems will design research studies for the cannabis companies, The Inquirer reported in March. The researchers will not be allowed to work with the plant or its products, because federal law outlaws marijuana in any form. Handling the drug would jeopardize federal grants and funds flowing from Medicare and Medicaid. That also means patients will be self-reporting data, making any research unlikely to be considered by typical peer-reviewed scientific journals.
Each company will sign up patients for studies, collect patient data, and share the information with the health system research team. The companies will pay for any research expenses. Many of Pennsylvania’s currently operating commercial cannabis companies say they are already sharing patient data with research institutions.
The three approved research growers are: PA Options for Wellness Inc., affiliated with Penn State College of Medicine in Hershey; Agronomed Biologics LLC, affiliated with Drexel University College of Medicine; and MLH Explorations LLC, affiliated with Sidney Kimmel Medical College at Thomas Jefferson University.
“We are delighted that the state Department of Health has awarded a clinical registrant permit to MLH Explorations LLC, with whom we have entered into a definitive services agreement and research agreement,” Jefferson said.
Among the financial backers of MLH Explorations, which plans to operate as Solterra Care LLC and will grow marijuana in Fairless Hills, is William Landman, a member of the Thomas Jefferson University board of directors.
Jefferson said its initial research will include an examination of “the impact of medical marijuana on the quality of life in patients with serious medical conditions” and the collection and cataloging of “which doses and forms of medical marijuana relieve symptoms in specific medical conditions.”
Drexel’s partner is Agronomed Biologics LLC, which plans to grow marijuana in Chester. With its win in hand, the company has six months to open the growing facility and a dispensary, chief executive Jonathan Cohn said. As to Agronomed’s work with Drexel, “we’ll come together with a candidate list of research studies we want to perform and they want to perform, prioritize those, and then kick them off,” he said.
Clinical trials at Drexel will examine the use of medical cannabis to treat conditions such as HIV, neuropathies, and PTSD, Drexel said. Pilot studies are expected to investigate the treatment of autism and opioid addiction with medical marijuana.
Penn and PCOM said they were disappointed that their marijuana-growing partners were not approved.
“We will continue to pursue opportunities to contribute to the development of new knowledge around the use of medical cannabis as a potential strategy to improve symptoms associated with chronic and acute illnesses among patients with unmet needs,” Penn spokesperson Patrick Norton said.
Penn’s partner was Curaleaf PA LLC, of Wakefield, Mass.
PCOM’s partner was Cansortium Pennsylvania LLC, a unit of a Miami company. “We are working with Cansortium to determine the best ways to move forward,” spokesperson Renee Cree said.
Temple, which was partnered with Laurel Harvest Labs LLC, of Lancaster, had no comment.
The Health Department said that it will meet next month with all eight medical schools and the three approved companies to discuss their research and the goals for patients.