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Patients requesting more rights in accessing medical marijuana

By E. Wendratama

Some patients with debilitating conditions praised the regulations proposed by the Department of Public Health, noting the DPH has listened to their concerns and revised its first draft. However, they still proposed changes in the regulations.

In a public hearing held April 22 at the DPH office, Steve Saling, who suffers from amyotrophic lateral sclerosis, asked the DPH not to limit a patient to a single marijuana dispensary. Using a voice recording device to communicate his views, he said, “Every treatment center [dispensary] will produce different varieties of medication, and as a patient I should have flexibility to try different brands of medicine until I find what best relieves my symptoms.”

As a patient with motor neurone disorder, Saling said marijuana provides him relief from ALS as it works as a muscle relaxant. “It calms the constant spasms in my muscles and rigidity in my joints without making me even weaker as happens with other medicine,” he said.

Scott Murphy, an Iraq combat veteran, raised concern about the draft’s definition on debilitating conditions. He asked for a broader definition of the term, saying that besides PTSD, there are other stress-related conditions experienced by veterans.

“I ask the DPH to also consider other chronic conditions that are causing a lot of suffering to veterans. And the qualifying conditions should be decided by their doctors,” Murphy said.

The same view was voiced by Linda Brantley, president of the New England Coalition for Cancer Survivorship, who said that debilitating has been defined too narrowly. “Medical marijuana has proven effective as a preventative measure for people struggling with nausea from chemotherapy and some of the after effects of cancer as well, including chronic pain,” she said.

The rights of patients receiving chemotherapy were also raised by Karen Munkacy, a physician and breast cancer survivor. She is asking the DPH to allow children suffering from cancer to use marijuana during chemotherapy. The draft regulations, considering the baneful effect of marijuana on children brain development, only limit the medicine to dying children.

“As a physician I have seen children go through cancer chemotherapy treatments and it is an unspeakable horror. We have many excellent anti-nausea medications, but they don’t always work. When they don’t, children go through agony,” she said.

Munkacy explained that the effectiveness of medical marijuana derives from its active ingredient called Delta 8 THC, which is available only in the plant, not in pill, nor any other form.

She said if only the dying children are eligible for medical marijuana, then it is not legally available for the 80% of children who live longer than 6 months after their cancer diagnosis.

“Childhood cancer is rare, but distraught parents, who are already dealing the nightmare of their child having cancer, shouldn’t also have the nightmare of buying their children’s medicine from back alley drug dealers,”she said.

Munkacy, who is also a board member of Americans for Safe Access, an organization promoting safe and legal access to cannabis, then proposed a requirement in the matter. “For the child to get this medicine, besides the parents or guardian consent, two doctors must agree that the child needs medical marijuana,” she said.

After hearing from the public, a small team in the DPH works on the draft again. Cheryl Bartlett, interim deputy commissioner of the DPH, said, “We will work quickly to synthesize public comment, and where necessary and appropriate, to amend the regulations.” Then, the team will present its new draft to the DPH council on May 8, and if the regulations be adopted by the council that day, they will go into effect by May 24.

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Drug prevention groups asking for stricter marijuana law

Substance abuse prevention groups raised various concerns on medical marijuana dispensation, ranging from possible black market activities, dispensary regulation, to edible marijuana-infused products. In the public hearing on April 22, they shared their views on the marijuana draft regulations.

Dave Morgan, chairperson of the Weymouth Youth Coalition Substance Abuse Prevention Team, said that the maximum limit of 10 ounces for a 60-day supply is extraordinarily high, and it could lead to diversions. “Based on a study, heavy users, who met criteria for marijuana dependence, used an average of 2 ounces per month.  The 10-ounce limit will tempt many people to request a 10-ounce recommendation, use up to 4 ounces per 60 days and divert the rest,” he said.

Morgan also proposed that all marijuana dispensaries should report their sales to the health officials like any other pharmacy. “Medical marijuana treatment centers must submit sales to the state Prescription Monitoring Program, as well as using the physician look-up as pharmacies are currently required to do,” he said.

His suggestion was supported by MaryanneFrangules, executive director of Massachusetts Organization for Addiction Recovery. She said that the system will help physicians identify warning signs of addiction and prevent “doctor shopping” for excessive quantities of prescription drugs.

Another group, Massachusetts Prevention Alliance, advised the DPH to define marijuana-infused product as both a food and a drug, therefore subject to the state’s food and drug safety laws. One of its members, Jody Hensley from Westboro, Mass., argued that the draft regulation runs counter to the public health and well-being of the citizens.

“By excluding these products from being defined as a food or drug, DPH is blatantly circumventing food and drug safety regulations. This exception must be deleted from this definition in this regulation.  Why avoid safety standards?” Hensley said.

She noted that the DPH’s definition will exempt the products, like cookies, chocolate and juice, from the state’s food safety guidelines. “These products should be under supervision of the Massachusetts Food Protection Program, within Bureau of Environmental Health in the Department of Public Health,” she said.

Her view on the food products was also highlighted by Morgan, who said, “This is compounding and it needs to be regulated by FDA and Board of Pharmacy.”

The DPH’s proposed regulation allows any dispensary to have one growing house outside of its distribution store. On this matter, the Massachusetts Prevention Alliance said there should be a notification to the community where a marijuana cultivation will be located. “Communities should be notified. The risk of diversion is too high to leave local officials unaware of potential marijuana sources in the neighborhoods,”Heidi Heilman, president of the Massachusetts Prevention Alliance, said.

Commenting on the draft in general, these organizations shared the same opinion that the state’s oversight obligations are weak because inspections on dispensaries are optional rather than mandatory, and are not regularly scheduled.Heidi Heilmann referred to the recent case in Maine where marijuana growing facilities violated regulations including use of pesticides.  She said the DPH must include a requirement for inspection and testing for contaminants.  “Medical marijuana treatment center licensing fees should be high enough to pay for the staffing required to do this properly,” she said.

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Attorneys and advocacy groups raised comments on dispensary rules

While noting that the majority of the regulations drafted by the DPH are well-thought out, several attorneys and coalitions of entrepreneurs said some regulations related to dispensaries are too restrictive and need to be reconsidered.

In a public hearing at the DPH office held April 22, a Massachusetts-based attorney Douglas Noble addressed two issues related to marijuana dispensary. First, the requirement that a dispensary must be operational within 120 days after its application approved by the DPH.

Noble said, “A hundred and twenty days may be a very unrealistic time frame to become operational with all of the uncertainties which exist with zoning issues, and being the first to open marijuana treatment centers in Massachusetts. But this may become less an issue for future developments.” He  proposed change to allow staff to extend the time frame, so long as the applicant is making substantial continuing progress to completion.

His second concern was related to a requirement that, when applying for a certificate of dispensary, every applicant must put at least $500,000 in an escrow account, which is to ensure that applicants have enough resources to operate. He recommended that upon the approval of an applicant, the escrow money should be released for the purpose of becoming fully operational.

Noble’s suggestion to extend the time frame was also voiced by Kris Krane, managing partner of 4Front Advisors, an Arizona-based consulting firm that provides marijuana dispensaries support in business operations and legal issues.

Krane said, “It will undoubtedly lead to certificate winners being forced to forfeit their permit.  Construction and build out of large-scale cultivation facilities can take a few months, and that doesn’t account for the time needed to pull building permits from local jurisdictions, a process that can take months in and of itself.” As a solution, he suggested the DPH to consider either extending this period to at least six months or building in a mechanism for operators to apply for extensions based on reasonable delays in permitting or construction.

As a representative of an organization whose clients are marijuana dispensaries and business entities throughout the country, Krane also asked the DPH to allow marijuana dispensaries to wholesale amongst themselves, which is similar to the Arizona marijuana program. “Wholesaling or trading amongst them will ensure that dispensaries have a more varied and robust product line for patients. If a dispensary in western Massachusetts is growing an effective strain (high CBD for example), they should be able to make it available to patients in more high-density places like the Boston area by wholesaling or trading with dispensaries in Boston,” he said.

The draft regulation allows a registered qualifying patient to change his or her designated treatment center only once every 120-day period.  Most representatives from the various groups attending the public hearing proposed to change this. One of them was by Tamar Todd, a staff attorney of the Drug Policy Alliance, a California-based advocate group for new drug policies.

Todd said experience in other medical marijuana states shows that producers and dispensaries may experience difficulty consistently providing enough marijuana to the patients in the amount they need. “If a treatment center runs out of marijuana or experiences crop failure or disease, patients registered with that dispensary will be forced to wait up to 120 days before being able to obtain marijuana from another dispensary. This regulation should be revised to allow patients to change their designation before 120 days, or else to allow a patient to designate multiple dispensaries at one time,” he said.

Another issue was raised by Michael Kann, an analytical chemist and pharmaceutical scientist, who argued the current draft is lack of clarity in quality control standards. He said the draft requires only cannabinoid profile testing, which would list ingredients without specific quantities of active cannabinoids. “Marijuana patients should have access to the specific information of the active ingredients. We use this information to make informed choices, just like we know Excedrin displays the number of milligrams of caffeine, ibuprofen, and aspirin found in a pill,” he said.

He admitted the testing is costly and complicated, and argued that reliance on self-regulation can lead to poor quality and compromised safety, as recently seen in the compounding pharmacy, oil industries and a dispensary in Maine that used pesticides in their growing facility.

“A reasonable solution is to specify in the bill a pathway for the creation of certified third-party laboratories that will provide proper cost-effective testing for multiple dispensaries,” he suggested. He said this mechanism will promote a conscientious and transparent medical treatment.

After this hearing, a small team in the DPH works on the draft again. Then, the team will present its new draft to the DPH council on May 8, and if the regulations be adopted by the council that day, they will go into effect by May 24.