A consortium of 25 Pennsylvania marijuana dispensaries announced it will collect patient research data for a national study on chronic pain already underway at the University of Michigan.
Sue Sisley is one of the lead researchers on the Michigan pain study. An Arizona physician who has conducted DEA-approved marijuana studies at the Scottsdale Research Institute to treat veterans suffering from PTSD, Sisley said the pain study already has enlisted about 600 patients in Nevada and Michigan.
Patients who use cannabis for chronic pain will be asked to complete a confidential online survey on an iPad at the participating dispensaries.
If the Michigan project signs up enough people — Sisley said 3,000 participants would yield publishable results — it could render the idea of Pennsylvania's state-sanctioned research program moot. It would show meaningful investigations into the drug could be conducted without granting special privileges to marijuana companies that enter into exclusive arrangements with Pennsylvania health-care systems.
"All medical cannabis license holders have a duty to participate in science right now and not wait for anyone else to fund that or get the Institutional Review Board approvals that they could be getting themselves," Sisley said.
The announcement of the Michigan pain project comes in the wake of a Commonwealth Court decision this week that, on its own, has the potential of derailing Pennsylvania's research program.
The state's current marijuana growers and dispensers — many of which are participating in the Michigan pain study — filed suit in March, claiming that the regulations governing the research program were unconstitutional and unlawful.
Judge Patricia A. McCullough found merit in the complaint and issued a temporary injunction on Tuesday. stopping the Department of Health from moving forward.
A spokeswoman said in a statement that the department "will continue to pursue our nation-leading research component and we are evaluating our legal options."
Pennsylvania statute allows eight of the state's health-care systems — called Academic Clinical Research Centers (ACRCs) — to pair with marijuana companies, which are referred to as Clinical Registrants (CRs).
Earlier this month, the health department approved five Philadelphia institutions to become ACRCs: Jefferson Health, the University of Pennsylvania, Temple University, Drexel University and Philadelphia College of Osteopathic Medicine.
The ACRC health-systems already have chosen their CR marijuana company partners, despite the fact that the arrangements must be approved by the state. But the existing growers say that by giving the schools the power to choose their partners, without a rigorously scored application process, the state "unlawfully" delegated the Health Department's permitting duties to the schools. The complaint hinted at allegations of pay-to-play.
Andrew Sacks, a lawyer who cochaired the Pennsylvania Bar Association's Committee on Medical Marijuana, said he had warned the Health Department "it would get in trouble" because the law and regulations did not appear to be fair and competitive.
"There's no provision to eliminate a CR unless the Health Department finds proof it bribed a health system," Sacks said.
"Hopefully the DoH will sit down with petitioners and work out something that is fair and competitive," said Sacks. "And by 'competitive' I mean open bidding for health system contracts by the companies, complete disclosures for both company and the health systems, and that they go through an application process that allows for other bidders who can be scored just like anybody else."
In testimony given before McCullough rendered her opinion, the director of the state's marijuana program, John Collins, said an injunction would be "quite simply, horrific" because it would be "extremely disruptive to the patients that are suffering in Pennsylvania." McCullough wrote that Collins' testimony overlooked the fact that qualified patients are already receiving medical marijuana.
A representative for Collins did not return calls requesting comment.
Anthony Campisi, spokesman for a group of investors who have paired with Jefferson Health, called the suit "an attempt to delay the work of world-renown academic research centers to get a competitive advantage on the part of these plaintiffs."
Judith Cassell, the lawyer representing the current growers and dispensary owners, said she expected Judge McCullough to hold hearings before the end of the summer.
"We are not against research," Cassell said. "We already have people who are growing and processing medical marijuana. The Department of Health could give them CR status. Many of them would love that status. And that would expedite the research. They'd be ready to go tomorrow."