Medical Marijuana Conference Has Attendees Buzzing About the Future

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by Tony West

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After a five-year struggle in the General Assembly, Pennsylvania became the 25th state to legalize medical marijuana on Apr. 17. But it will take at least six months for the Dept. of Health to craft regulations that permit this new industry to begin, with a couple of years of road-testing after that.

This process began with a bang at St. Joseph’s University on Jul. 8, where State Sen. Daylin Leach (D-Montgomery), the prime sponsor of Act 16, convened a “Medical Marijuana Regulatory Palooza” that drew 300 experts from across the nation – physicians, lawyers, businesses, producers, patients and public officials – to share their experiences in the industry, in hopes that the Keystone State can learn from others’ successes and snafus.

Pennsylvania’s wait may pay off with better regulations. “We have learned two things from other jurisdictions: The sky does not fall” when marijuana is legalized in any fashion,” Leach said, “and there is a way to do this professionally.”

But much remains to be done in order for medical marijuana to work as an industry. Coordinating these efforts will fall mainly on the DOH. But local governments, law-enforcement agencies, and medical and financial professionals will all have to adapt as well.

At present, said Sarah Speed, executive director of the House Judiciary Committee, “The DOH does not have a system. All entities must agree on a joint course of action.”

The Distribution Conundrum

Act 16 envisions 150 dispensaries across the state. But it is not clear that some rural counties can support one. These businesses are expected to have at least $500,000 in the bank before they even apply for a license. Since the act envisages strict controls to keep cannabis out of the hands of recreational users, they must bear substantial compliance costs. Too many costs with too few patients can kill off clinics, as New Jersey has learned to its chagrin.

Some participants suggested that fewer dispensaries – but with delivery options – may prove more viable in some areas. Marijuana usage will be permitted for 17 different medical conditions, some of which make it hard for patients or care-providers to get around.

Other areas will have to grapple with Act 16’s geographical limits on clinics, which cannot be within 1,000 feet of schools and similar facilities. “Philadelphia is mostly red (off limits),” said Leach’s Chief of Staff Zachary Hoover, while noting the DOH has the power to waive this restriction.

STATE SEN. Daylin Leach organized an intensive conference to ponder the complexities of medical-marijuana regulation in Penna.

STATE SEN. Daylin Leach organized an intensive conference to ponder the complexities of medical-marijuana regulation in Penna.

“Polls show there is 88% support for these clinics – but not necessarily on your block,” Hoover added.

Overzealous local zoning and regulations can pose another threat to viability. Some municipalities will seek moratoria on clinic development; others will try to impose their own security inspections on top of the state inspections. And in some, noted Jay Czarkowski of Canna Advisors, “local support is sold to the highest bidder.”

“I urge you to delineate the boundaries between local and state regulators,” said Jeremy Unruh of PharmaCann LLC, which is involved in the medical marijuana industry in several states. “As a cultivator and investor, and former prosecuting attorney, I don’t want that.”

Adam Fine, a Massachusetts attorney, said strong Commonwealth regulations there have made municipalities comfortable with staying out of the fray.

“Clinics shouldn’t be overregulated or underregulated by local zoning codes,” remarked David Kimmerley, a city planner in Allentown.

But there was pushback in favor of local control. Philadelphia Councilman at Large Derek Green stated, “The locality must take the lead in educating the public.” And he worried that this new state legislation might “mirror the gaming process” that stripped municipalities of any say over the location of casino venues.

Hoover replied that the legislation started out with a very state-run orientation but did make concessions to local input as it was rewritten.

Taking a Patient Approach

Dispensaries don’t just need permits; they need patients. And patients need doctors. Physicians cannot “prescribe” marijuana since it is a plant, not a specific drug; but they can write a “certification” of medical need that amounts to the same thing.

The growth of the medical marijuana movement has been driven largely by patient groups, not by care providers. These groups have decided, after much unscientific (and illegal) trial and error, that marijuana does not deserve the “Class I” status it has been stuck with under the federal Scheduled Substances Act. “Class I” means the drug has no recognized medical value that cannot be met by other drugs processed by the pharmaceutical industry.

In fact, these advocates argue, it is a far superior remedy for sufferers of many debilitating conditions whom the lawful pharmacopoeia is failing.

But at the moment, no one knows how many of these patients there are in Pennsylvania – either movement activists or potential recruits – a status unlikely to change until information on the new system has a chance to spread amongst affected patients and their families.

All affected patients (and/or caregivers who shop for them) must register with the DOH, which will issue them photo IDs. But until the DOH creates a database, it will be hard to predict who and where the patients are.

Research for Tomorrow

The lack of applicable medical research into marijuana compounds is primarily a result of its Class I status, which most legal and medical experts now consider an obsolete classification. As a result, the best work in the field is now being done abroad. Clinicians and researchers in attendance at the event bemoaned this national failure, in one way or another. They want to find out what works, and they want to start now. They don’t care about historic influencers like the 1936 film, Reefer Madness, which portrayed marijuana as an enemy of civilization and decided its Schedule I status.

But this may change. On May 27, Thomas Jefferson University launched the Medical Cannabis Research & Education Research Center as a first-in-the-nation sponsor of serious scientific inquiry into this topic. Its head, Dr. Charles Pollack, called it “very collaborative in nature.”

On the agricultural front, farming must be done in Pennsylvania. This is to eliminate the inconvenient conflict between state and federal laws, the latter of which prohibit interstate commerce in pot. That’s great for local business, but may result in higher costs for consumers.

In 2013, Deputy US Attorney General James Cole wrote what is now known as the “Cole memo.” It’s a legal fig leaf in which the Feds promise to leave states that legalize marijuana alone, without conceding the ultimate authority of federal statutes. It can be revoked by the next President.

Clinicians at the conference said physician education was key. Doctors won’t recommend what they do not know.

Some said the younger generation of doctors was more receptive to medical marijuana. But an out-of-state attorney said she specialized in setting up marijuana practices for older physicians toward the end of their career – starting with her own father. “It’s less work and they have less to lose,” she explained.

Medical experts want to know what’s in their medical marijuana precisely. They have called for strict reporting under Act 16 which will enable clinicians to study which strains of cannabis will work best for which conditions.

Marijuana contains 85 related compounds. The top two are tetrahydrocannabinol and cannabidiol. But different strains of the plant have different levels of all these chemicals and nobody is really sure which work best for which problems, or which cause which problems. Researchers can’t work without controlled data, and they’re hoping Act 16 will be regulated in a way that facilitates research.

Solving Logistical Puzzles

One puzzle is the role of the attending physician or pharmacist at a dispensary, as required by Act 16. Other parts of the act forbid physicians who recommend cannabis from a financial interest in dispensaries. The conference agreed this pro could be an employee but not an investor. And there was a strong sense that the job would be more appropriate for pharmacists in most cases.

Dr. Stephen Hunt, a radiologist at the University of Pennsylvania, said attention must be focused on how to “solve the piece of the purpose of the attending physician.” The Commonwealth’s Prescription Drug Monitoring Program (primarily targeted at opioids these days) provides a good regulatory framework that is already in place, and he advised regulators to copy it for cannabis.

Banking is another conundrum for the medical marijuana industry. Most banks, including all large ones, are regulated by the Federal Deposit Insurance Corp. Since marijuana remains illegal at the federal level, these banks cannot accept money from a marijuana business even if it is legal at the state level. This can create challenges for people who are used to transparent dealings. One attorney recounted the discomfiting experience of carrying a satchel stuffed with cash through Manhattan after a meeting with a client.

However, state-regulated banks and credit unions may do business with this industry, although many of these smaller institutions are leery of such potentially controversial clients. On the West Coast, some banks have gotten into trouble for embracing marijuana money too openly.

In addition, attorney Stephen Schain pointed out, the administrative challenges of medical marijuana money may not make it cost-effective for smaller institutions. “The reporting requirements are very onerous,” he stated. “If you’re a banker, you want to make money.”

However, reported Schain, a US Treasury source counted 321 institutions across the nation that are quietly accepting legal cannabis accounts. In Philadelphia, United Savings Bank is said to be working with one dispensary in its start-up phase. Even so, there is no guarantee that a bank will continue such a relationship once a dispensary is open.

But there were many consultants at the conference who promised to facilitate banking arrangements, for a fee.

Law-enforcement departments will also face new challenges. To aid police on the street, Act 16 was specifically crafted to exclude “flower,” the part of the plant most people identify with smoking cannabis. Medical marijuana can only be consumed in pills, oils, ointments, vapor inhalers, tinctures or liquids.

But these products begin with highly concentrated extracts, with up to 90% of potent ingredients. And that can create dosing problems, said Teresa Lazo, Gov. Wolf’s chief counsel for the Board of Medicine. Many patients find it easier to regulate their intake by smoking pot, where the concentration can be much lower – say, 15%. They are looking for symptom relief, but want to avoid getting high.

“To say that 15% is not OK but 90% is OK seems to get it backwards,” Lazo said. But this compromise was necessary to get the law passed. Public support for recreational marijuana is not as strong as for medical use.

Ready or not, this industry will find public support is now there, Leach said.

“We had to deal with reams of misinformation at first,” he said. “But the public has changed dramatically in the last five years. All the opposition melts away in the face of a sick kid.”

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