Marijuana: the hardest legal drug to get?

Date: 8/20/2015

Dispensaries’ struggle with licensing process leaves patients with few options

Editor’s note: This is the first in a three-part series in which Reminder Publications will explore issues related to medical marijuana in Massachusetts – the current status of registered marijuana dispensaries, medical uses of marijuana, and law enforcement.

While multiple petitioned questions for the November 2016 ballot aimed at legalizing marijuana for recreational use are awaiting approval, the jury is still out on the drug’s first approved use in the state – medicinal purposes.

The Act for the Humanitarian Medical Use of Marijuana was approved by 63 percent of voters at the November 2012 election, but the efficacy of not only the drug, but the rules and regulations governing it, remain in question largely because for most in the state, the product has yet to be available for widespread distribution.

Because marijuana is not approved by the Food and Drug Administration (FDA) for medicinal use and remains classified a Schedule 1 drug by the Drug Enforcement Agency, it cannot be distributed by the same means as other prescription medications, most commonly through a pharmacy. With that in mind, the Department of Public Health has attempted to devise a policy through which patients can get the medication they are legally approved to take.

“The Department of Public Health has attempted to work within the law approved by the voters and establish protocols through which medical marijuana can be made available to the public safely,” Scott Zoback, DPH spokesperson, told Reminder Publications.

There’s just one problem.

“Medical use was approved in January 2013; two and a half years later, there are still no dispensaries [in Western Massachusetts],” Dr. David Getz of MariMed Consults, a Springfield-based physician’s office specializing in the certification needed to obtain medical marijuana, said.

Since medical marijuana policies were enacted, just one registered marijuana dispensary (RMD), Alternative Therapies Group located in Salem, has opened.

Soon, however, Western Massachusetts residents will at least have some opportunity to obtain the drug through a dispensary with the anticipated September opening of New England Treatment Access (NETA) in Northampton.

“We’re the only dispensary west of Salem and we take this responsibility very seriously,” Norton Arbelaez of NETA said. “There has been a lot invested in this – a lot of blood, sweat and tears, so to reach this point, we’re very excited. There are many patients who have been waiting anxiously for the opportunity to access the medicine they need, so we are looking forward to a lot of success.”

NETA also has proposed a facility in Brookline that is awaiting a Certificate of Registration and both locations would sell marijuana cultivated in a facility in Franklin.

NETA has a target open date of Sept. 15 and is in the process of hiring 25 staff members ranging from managers to patient services representatives to security.

Northampton officials confirmed to Reminder Publications NETA was in compliance with zoning and building regulations and while health officials did not respond to a request for comment, Arbelaez said the operation will operate within local and state guidelines.

All the nonprofit is waiting on is the final go-ahead from the DPH.

“We are a vertically integrated operation, which means we have to have 100 percent of our products ready for our patients,” Arbelaez said. “We are in the midst of our first harvest. The hold up is making sure it is all ready for sale. Then we have one final DPH inspection.”

In the meantime, NETA has been developing community relations. Northampton Mayor David Narkewicz has also toured both the retail dispensary and the cultivation operation. On Aug. 12, the company hosted a well attended “meet-and-greet” at the Fairfield Inn and Suites as an opportunity to introduce themselves to the public.

Also, in an effort to streamline the process prior to the RMD’s official opening, NETA is inviting patients to its facility to receive educational materials and assistance with the registration process.

“We hope patients will visit the facility and register with us so that they can learn about the broad range of products we will offer. This is a great opportunity for patients to have their questions answered regarding the process and to see for themselves what safe, legal access will look like in Western Massachusetts,” Arnon Vered, executive director of NETA, said.

Patients can visit NETA Thursday and Friday, noon to 7 p.m., and Saturday, 10 a.m. to 3 p.m., until the facility opens. More information is available at www.netacare.org.

Variety of treatments

The company advertises a variety of strains of marijuana, as well as other products, ranging from topical treatments – including lotions or balms – to edibles – such as lozenges, gel tabs and baked goods – to non-combustible products for vaporizers.

“We will have a range of non-smoke-able products,” Arbelaez said. “As time goes on, we will be able to offer even more options for patients.”

Zoback indicated that any product other than the actual plant material needs to be licensed approved for use by the state.

“Under the law, dispensaries are allowed to sell plant products,” he said. “For edibles and other forms, they would have to be licensed as well. The manufacturers would have to report things such as other chemicals in the product and there are packaging standards that have to be adhered to as well.”

Arbelaez said all products sold by NETA have been approved, adding, “We’ve had to submit thousands of pages of documents outlining all aspects of our operation.”

How much the products will cost consumers is not known because state law prohibits RMDs from advertising their prices.

The RMD also claims its products would be available in high-cannabidiol (CBD) formats.  

Dr. Kevin Hill, director of the Substance Abuse Consultation Service in the Division of Alcohol and Drug Abuse at Boston’s McLean Hospital, assistant professor of psychiatry at Harvard Medical School and author of “Marijuana: The Unbiased Truth About the World’s Most Popular Weed,” explained high CBD could be the most beneficial of marijuana varieties when used medicinally.

Cannabidiol is one of the two major components found in marijuana, the other being the psychoactive THC, which provides the “high” recreational users seek.

“Cannabidial is really in many way different from THC. It’s not psychoactive; it doesn’t make you high,” Hill said. “The reality is with the marijuana plant that you buy, you can essentially adjust the THC to CBD ratio one to one, so if you increase the THC, the CBD goes down more or less. If you were really interested in using marijuana to get you high, you want the high-THC marijuana. If you are somebody more interested in medicinal purposes, then you would want high-CBD marijuana.”

Procedural issues

Even with an RMD coming to Western Massachusetts, availability is still a huge problem, with the most apparent obstacle being the state’s rigid approval process.

According to state records, as of Aug. 13, NETA is one of just four dispensaries to receive its Certificate of Registration, meaning it was authorized to commence operations, pending a final inspection.

State law initially allowed for 35 dispensaries throughout the Commonwealth. Originally, RMDs had to submit applications by Nov. 21, 2013 and the state’s original plan was to announce which applicants received preliminary approval and would move on to a second phase. During that second phase, RMDs were required to complete the build-out of their cultivation and dispensing facilities for inspection by the state.

However, the process was beleaguered by delays.

The state originally announced 20 RMDs would be awarded permits in January 2013, but then in June stated that just 11 of the original 20 would advance to an inspection phase, a move that left the state’s three largest communities – Boston, Worcester and Springfield – out of the process.

To date only 15 facilities, run by 13 entities, were even able to gain provisional certifications with another four, including Patriot Care Corp.’s proposed Greenfield location, earning that status in November 2014.

According to the state law, at least one RMD license must be granted in each of the 14 counties.

In response to criticism regarding the policies, Gov. Charlie Baker’s administration and the Department of Public Health announced in April an overhaul of the application process in an effort to alleviate some of the concerns of nonprofits wishing to open facilities.

The new application process was structured to mirror that of other healthcare facilities under the DPH’s purview.

“The applications for medical marijuana dispensaries will be handled in a similar manner to applications for pharmacies,” Zoback said.

With new application regulations, there is no deadline; applications can be submitted on a rolling basis, which will allow the state to evaluate each applicant independently, provided they meet the standards of the policies related to safety and background checks, which were also strengthened in the overhaul.

“The Commonwealth has an obligation to license dispensaries consistent with the requirements of the law,” Secretary of Health and Human Services Marylou Sudders said. “The [previous] methods we inherited have prevented our ability to do so, requiring changes to deliver a more timely and transparent application process with the end goal of assuring patients have safe access to the care they deserve.”

Arbeleaz said he sympathizes, especially with patients voicing criticism in the process, but said overall, the delays have been equally understandable.

“Big picture, we have to remember that we are undoing 70 years of prohibition, so it’s a big change for state and local government,” he said. “If I were a patient, I can understand the position that this process has been very slow, but with something this complicated, you can expect a learning curve. We have been working with regulators hand-in-glove.”

Patients still waiting for relief

In the meantime, however, no options currently exist for patients in the Greater Springfield area. Local municipalities have released requests for proposals for RMDs and 104 dispensary applications statewide have been received, but none of the applicants have gone farther than the submission stage through the new process. Those applicants must also submit management and operations and siting profiles.

Locally, three Springfield corporations – Debilitating Medical Condition Treatment Centers Inc., Mass Alternative Care Inc. and Holistic Industries Inc. – have filed applications of intent, with the first two submitting one and the latter issuing three. Hampden Care Facility Inc. in Chicopee and Heka Health Inc. of Westfield also each filed three applications.

Elsewhere in Western Massachusetts, Happy Valley Compassion Center Inc. (one) and Far East Operations Limited (one), both of Greenfield, Manna Wellness Inc. of Pittsfield (three) filed applications.

As of Aug. 13, Hampden Care Facility Inc., Mass Alternative Care and Debilitating Medical Condition Treatment Centers Inc. have been invited to submit a management and operations profile.

With nowhere else to turn, patients have had only one legal option.

“Rather than encourage going to drug dealers, the DPH sort of has allowed anyone with medical permission to grow for personal use,” Getz explained.

According to the law, until the RMDs are open, patients approved by a doctor and certified with the state, or their certified caregiver, are allowed to grow up to a 60-day supply for their own medicinal purposes.

Regulations also state if an RMD is not "within a reasonable distance of the patient's residence" and there are no RMDs that offer delivery, that person can apply for a hardship cultivation registration, for an additional $100 fee. If an RMD up and running locally, but there are circumstances that prevent a patient or caregiver from accessing it, they may be granted that status as well.

A 60-day supply is considered to be 10 ounces of marijuana, however, the law doesn’t specify how many plants can be grown. A recent memo to law enforcement states only “there should be no more than what is necessary to meet the patient’s individual needs.”

Because many caretakers are responsible for multiple patients, House Bill 2065, sponsored by state Rep. Frank I. Smizik (D-Brookline), was sent to Beacon Hill requesting, among other things, that the law be changed to allow caretakers to grow enough to serve 10 patients.

That bill went before the Joint Committee on Public Health for its first hearing on July 14.

Part two of this series will examine the medical uses of marijuana and the perceived benefits and pitfalls.