Inside the Complicated World of Pennsylvania’s Medical Marijuana System

Act 16 legalized medicinal cannabis, but many dispensaries are still tangled in a web of red tape.

 

It ain’t easy being green. Marijuana, unlike its botanical brethren tobacco and sugarcane, hasn’t been proven to cause disease or addiction. And yet, it took years of wrangling for the Pennsylvania legislature to legalize it for medical purposes. When Act 16 was passed in 2016, the bill’s chief architect and cheerleader, state Sen. Daylin Leach, a Democrat serving parts of Delaware and Montgomery counties, called it “the most significant piece of social policy enacted in Pennsylvania in generations.”

While that remains to be seen, what’s clear is that Act 16 has several Catch-22 legalities, and it stands on somewhat shaky medical ground. The law approved medical marijuana for a petite list of 17 diseases (see sidebar), including cancer, Crohn’s disease, glaucoma and HIV/AIDS. Legal delivery methods are liquids, gels, creams, pills and tinctures. Vaping is allowed, but smoking is not—and neither are edibles. Act 16 also created an intricate grower, dispensary and “prescription” system to be implemented by the Pennsylvania Department of Health.

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How does the system work, and how can you get some? Well, the first thing to know about medical marijuana is that you shouldn’t call it “medical marijuana.” Weed, pot, chronic, blunt, spliff—industry insiders don’t use any of those terms, either. Chris Kohan calls it “MMJ.” Skip Shuda uses the phrase “medicinal cannabis.” Both were awarded licenses to open multiple dispensaries in Pennsylvania.

The Department of Health didn’t exactly roll out the green carpet for MMJ. Obtaining licenses required an American Ninja-style application process. Still, the passage of Act 16 sparked a “green rush” of investors wanting to get into the canna-business. Whether medicinal or recreational, legalized marijuana has two things entrepreneurs look for: demand and growth potential.

Sources familiar with the process say that applying for a grow license required a bankroll of more than $2 million. At approximately $200,000, dispensary applications are more affordable, but they’re still pricey gambles. A Media-based entrepreneur with decades of start-up experience, Shuda knows that every venture carries risk. “We had a one-in-10 chance of getting a dispensary license,” he says. “We would’ve been in for $150,000 and had a 90-percent chance of losing that.”

In June 2017, the Department of Health awarded the highly coveted licenses. Kohan’s Healing Center will open three dispensaries in the southwest corner of the state. That’s Region 5, one of six the Department of Health created to sprinkle dispensaries throughout Pennsylvania.

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GREEN LIGHT

The 17 conditions approved for cannabis treatment through PA’s Act 16

  • Amyotrophic lateral sclerosis
  • Austism
  • Cancer
  • Crohn’s disease
  • Damage to the nervous tissue of the spinal cord, with objective neurological indication of intractable spasticity
  • Epilepsy
  • Glaucoma
  • HIV/AIDS
  • Huntington’s disease
  • Inflammatory bowel disease
  • Intractable seizures
  • multiple sclerosis
  • Neuropathies
  • Parkinson’s disease
  • Post-traumatic stress disorder
  • Severe chronic or intractable pain of neuropathic origin, or severe chronic or intractable pain in which conventional therapeutic intervention and opiate therapy are contraindicated or ineffective
  • Sickle cell anemia

Region 1 includes Philadelphia, Bucks, Montgomery, Delaware, Chester, Lancaster, Berks and Schuylkill counties. Shuda is COO of Chamounix Ventures. Under the name Keystone Shops, he’ll open dispensaries in Devon, King of Prussia and Upper Darby.

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Only 27 dispensary licenses were granted, and the selection process was almost immediately called into question for its lack of transparency. People who wrote checks with a lot of zeroes—including several prominent Main Liners—cried foul. Shuda believes that the solidity of his group’s applications won those licenses. “We put together comprehensive plans,” he says. “Some of the selection process wasn’t completely open, but we were all told what the grading process would be. The state seems to have adhered to that.”

Dispensaries and “grows” had six months to be open for business. That was a tight deadline for dispensaries and nearly impossible for grows. They had to be built, pass a host of inspections, then grow and process plants. Given all of that, most grows won’t have product until March, possibly April. “We can’t open dispensaries until we have product to sell,” Kohan says. “We can’t import it from any other state. It has to come from Pennsylvania.”

And there’s no fudging that, Kohan says. Every legal plant in the state will be tracked through MJ Freeway, a seed-to-sale software system mandated by the Department of Health. Patients and their purchases will also be monitored via MJ Freeway. “The state created this system, and every dispensary has to adhere to it,” he says. “Given the level of vigilance the state is promising, it would be unwise to mess around with that.”

Kohan and Shuda adhered to the state’s strict parameters for the physical composition of their dispensaries, which include extensive video surveillance, secure storage and a complicated delivery system. “Security requirements for dispensaries exceed those for a pharmacy or liquor store,” says Shuda. “Arguably, those are much more dangerous substances. But in order to pass the law in a relatively conservative state like Pennsylvania, legislators had to include those things.”

Kohan and Shuda say their dispensaries are on target to open whenever MMJ becomes available.

But there’s another hurdle. Dispensary owners need something money can’t buy: the cooperation of physicians. To enter a dispensary, you need a state-issued MMJ card. To get the cards, you need letters from doctors. Those letters are recommendations, not prescriptions. Not every physician can issue recommendations. To qualify, they have to register with the state and take four-hour courses.

The local healthcare community is proceeding with caution. As of September, Crozer-Keystone Health System wasn’t participating in the program, and inquiries to Main Line Health went unanswered. Had the state legislature legalized recreational cannabis, physicians wouldn’t have to be involved in MMJ. But as it stands, the Department of Health is asking them to endorse the use of cannabis for medicinal purposes. More than a dozen, all of whom requested anonymity, expressed reservations about recommending MMJ. “Do whatever you want recreationally,” one physician says, “but don’t ask me to sign off on cannabis as medical treatment.”

Dispensaries will be staffed by medical professionals, including doctors, pharmacists, physician assistants and nurse practitioners. Keystone Shops’ dispensaries are creating private areas in which staff members brief patients on how to get physicians’ recommendations and state-issued cards. “We’re also looking at creating centers of excellence at our dispensaries,” Shuda says. “We want to build relationships with patient advocacy groups and become destination sites for cannabis treatment of specific conditions.”

Post-traumatic stress disorder, autism and seizure disorders were among the conditions Shuda listed as possibilities.

But good marketing doesn’t mean it’s good medicine. Despite the widespread belief that cannabis has medicinal value, there’s little research proving it. Dr. Charles Pollack is trying to change that.

Pollack is one of the prominent Main Liners who believes in the future of cannabis. He’s the director of Thomas Jefferson University’s Lambert Center for the Study of Medicinal Cannabis and Hemp. Among its directives are educating healthcare professionals about cannabis treatment and developing solid research on its usage for a variety of medical conditions.

It’s the lack of existing clinical research that makes many physicians hesitant to recommend it to patients. How will MMJ interact with medications that patients are currently taking? What are the correct dosage amounts? Where are the clinical trials proving cannabis’ efficacy? “I understand their concerns,” Pollack says. “I’m accustomed to Phase 1-3 clinical research with placebos, double-blind studies and other FDA protocols. It ain’t gonna happen with cannabis—not anytime soon.”

Marijuana is federally illegal and, therefore, can’t be approved by the Food and Drug Administration. Technically, marijuana is a Schedule 1 drug, making it more dangerous than opioids, cocaine and meth. While many scoff at that, the law stands.

Act 16 does allow for the creation of university-based cannabis research centers in Pennsylvania—sort of. Chapter 20 of the law details requirements for special dispensary licensees, called clinical registrants. Those CRs must have $15 million in capital and affiliate with academic clinical research centers, which are medical schools that have acute-care hospitals. Jefferson qualifies, as do Penn, Temple and Drexel. “It’s an awesome idea, but is widely misunderstood,” Pollack says. “Too many people think that this means academic medical centers will own and operate dispensaries. That would put them in direct violation of federal law and put all of their federal funding at risk.”

Medical cannabis research can be conducted in Pennsylvania, but only with product from a single government-designated grow located in Mississippi. Neither Jefferson nor any other university can do clinical research on the medical cannabis grown in Pennsylvania. “Bottom line is that the real potential of Chapter 20 is limited until federal law changes,” Pollack says.

Despite the lack of clinical research, Pollack believes MMJ is safe to use for specific conditions. “There are certain indications for which there is reasonably good—but not great—data,” he says. “Many of my colleagues have yet to dip their toes into the cannabis-treatment literature that does exist. Before you say that you don’t trust cannabis, take our four-hour course and learn what’s out there.”

You don’t have to be a rocket scientist—or have a medical license—to understand some of marijuana’s effects. People with depression and anxiety-related disorders have been self-medicating with it for years. Cannabis stimulates appetite, which is why it seems almost inhumane to deny it to people undergoing chemotherapy and those with AIDS. Parkinson’s, Huntington’s and multiple sclerosis—these nasty, incurable diseases cause extreme suffering and are approved for MMJ as part of Act 16. But there’s healthy skepticism around other approved ailments. Case in point: back pain. “All of the other conditions in Act 16 are a bit more serious and rare, but chronic pain is almost ubiquitous,” says Dr. Ari Greis, one of the only doctors who agreed to speak on the record.

A Rothman Institute physician, Greis specializes in the non-operative treatment of spinal and musculoskeletal disorders. Have his patients been asking about MMJ? “All the time,” he says. “Many of those patients aren’t candidates for surgery, or had surgery and still have pain. A majority have tried different pain-management treatments without relief and are desperately looking for new options.”

Greis is in favor of MMJ as an option when conventional pain management has failed. He’s actively involved with the Lambert Center’s research and has fulfilled the state’s requirements so that he can prescribe MMJ when it becomes available.

How does MMJ heal bulging or herniated disks that cause back pain? It doesn’t. Cannabis seems to work on the brain’s perception of that pain. “The brain registers the pain signal coming from the spine, which is neuropathic pain,” Greis explains. “Cannabis has been shown to be moderately effective in treating neuropathic pain in adults. But that doesn’t mean it’s right for every patient.”

One of MMJ’s half-proven benefits is that it can reduce patients’ need for opioids. “There is some evidence that cannabis can have a synergistic analgesic effect when used with opioids,” Greis says. “Chronic-pain patients with access to medical cannabis have been shown to use less opioids—perhaps by as much as 50 percent. States with legalized medical marijuana have seen, on average, a 25-percent reduction in deaths from opioid overdoses.”

While open-minded, Greis is far removed from the “green doctors” who populate other states. He does have reservations about MMJ. “The drug is coming out before we’ve done our due diligence and properly studied cannabis,” he says. “Most docs—myself included and many Rothman docs—are hesitant because we don’t know the best ways to prescribe it.”

But there’s no denying that MMJ is in demand. “If patients want MMJ, they’ll find a doctor who can support their decision to try it,” Kohan says.

Shuda puts it more gently. “We see patient demand being the primary driver,” he says. “We also want to get behind educational programs for patients and physicians.”

Meanwhile, Leach is angling to get recreational cannabis legalized through Senate Bill 213. “Many of [the senator’s] colleagues—including some of the most conservative—tell him privately they support legalized marijuana, but that they can’t support it publicly,” says Steve Hoenstine, Leach’s spokesman. “They cite objections from prosecutors and law enforcement. But they also see that it no longer makes sense to spend hundreds of millions of dollars to lock up people for smoking a plant. Marijuana will be legal very soon, both because an overwhelming majority of Pennsylvanians support it and because the state budget would realize an extraordinary infusion of funding, without requiring an increase in the sales tax or income tax.”

Stay tuned, Hoenstine says. Sooner or later, Pennsylvania will be rolling in green.

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