The medical marijuana program in Pennsylvania is about to enter unprecedented territory as it embarks on the nation's first state-sanctioned research program.
Medical schools will partner with marijuana companies. The med schools will design research studies. The companies, which will grow cannabis and sell it at their dispensaries, will enlist patients for the studies. The companies will collect patient data to be analyzed by the medical schools.
Unlike traditional drug studies, which provide experimental medicines at no cost, patients will buy the drug under investigation.
"It's not a normal pharmaceutical research structure by any means," said Eric Hagarty, deputy chief of staff to Gov. Wolf. "The conflict with federal law is primarily the reason for that."
The federal government considers all forms of marijuana to be illegal.
Backers say the program's research arm is unique in the U.S. and could make the state a global hub for cannabis science. Philadelphia may host up to five academic centers investigating applications for the drug.
Enabling this to happen is a provision of the marijuana law many call the "Jefferson Amendment."
Nicknamed after Philadelphia's Jefferson Health system, which was instrumental in the law's creation, the Jefferson Amendment is officially known as Chapter 20 of the state's medical marijuana act. It allows as many as eight health systems to each pair with a private company. A health system, under the law, is defined as a medical school with an acute-care hospital.
In language only a bureaucrat could love, the law calls the medical schools "Academic Clinical Research Centers" (ACRCs) and deems the marijuana companies "Clinical Registrants" (CRs).
"The whole goal is to bring research and sophistication to cannabis that doesn't exist in the rest of the state or the country," said James Connolly, a former vice president at drug maker Wyeth. Connolly will head Solterra Care, LLC, the CR affiliated with Jefferson. "It will put us on the map if Philadelphia has three, four or five research centers and brings some credibility to the industry."
Drexel, Temple, and the University of Pennsylvania are each expected to participate as research centers. Philadelphia College of Osteopathic Medicine is also angling to get in, though the school lacks a hospital on campus.
The state Department of Health will begin accepting applications on April 5.
The research program will run parallel with the state's commercial medical marijuana enterprise, which was launched Feb. 15.
Jefferson was one of the first academic institutions in the United States to move aggressively into the cannabis space. In 2016, Thomas Jefferson University created the Lambert Center for the Study of Medicinal Cannabis and Hemp, the first center of its kind, to support marijuana education and research.
Lambert director Charles Pollack was among the first to see the value of collecting cannabis patient data on a statewide scale.
"It's not the kind of research that will change the world, but it's an important step in the right direction," Pollack said. "It's limited to observational studies [without a control group], but it will create a pathway to do more rigorous investigations."
Even before the state published the regulations that govern the research program on March 17, Jefferson had inked a memo of understanding with MainLine Investment Partners, a private-equity firm based in Wynnewood.
MainLine's CEO is William Landman, who is also the former chairman and current member of Jefferson Health's Board of Trustees. Landman is widely given credit for instigating the research idea and pitching it to state lawmakers.
The program was considered so unlikely that national marijuana advocacy groups never expected it to happen.
"No one had ever gone through this because of the legal and political implications," said Becky Dansky, legislative counsel for the Marijuana Policy Project.
Other states that have legalized marijuana had considered research programs, Dansky said, but dropped the idea because federal funding for universities and hospitals could be in jeopardy. "We didn't think any state would go through with it," she added.
Pennsylvania came up with a novel way to skirt the perils. Other states had proposed to house all marijuana operations on school campuses. In Pennsylvania, only the firms will handle the plant and products. The medical schools will stick to analyzing patient data.
Adding Chapter 20 earned support for the marijuana bill from reluctant Republicans in Pennsylvania. "It pushed it over the line in the house," said State Rep. Katharine Watson (R., Bucks), who sponsored it.
Landman's business partner, David Clapper, said many Jefferson doctors were strong supporters of medical marijuana before the law was passed.
"One oncologist said 30 percent of his cancer patients were already using it" to relieve acute pain and stimulate their appetites, Clapper said.
MainLine is making "a sizable investment" to build the Solterra CR from scratch. The state requires a minimum commitment of $15 million, "but it's going to cost a lot more than that," said Clapper.
After the permits are awarded in June, it may take Solterra about nine months to become operational, Clapper said. "We don't have the benefit of being part of a larger group."
The state medical marijuana market is forecast to grow from $350 million to $600 million by 2020. Clapper said sales will help recoup MainLine's investment. But intellectual property — proprietary knowledge garnered from the development of novel cannabis strains and medicine delivery — may generate the biggest profits, analysts said.
Industry insiders said many of the state's eligible med schools already have aligned with marijuana producers, which will be awarded permits without having to go through the competitive process. The state required the first phase of commercial marijuana growers and dispensaries to undergo a scoring review by an anonymous panel of judges.
Chris Visco, co-owner of TerraVida Holistic Center dispensaries, fears that pioneers such as herself may be squeezed out by the better-funded CR start-ups. "These research people can just buy their way into the program," said Visco. "The permits are going to be just handed to them."
Hagarty said the CR companies would be judged as critically as anyone who received a commercial permit. "It's not in our interest to give a permit to just anyone who wants one," he said.
It's unclear if research can be conducted by commercial growers or dispensaries who are not formally affiliated with med schools through the Chapter 20 program.
Pollack, of Jefferson's Lambert Center, said he thought the department of health had done its best to create a level playing field.
"I don't think there is going to be any shortage of customers," Pollack said.