BOSTON – Today the The Public Health Council approved regulations for the medical marijuana program that was supported by voters in 350 out of 351 communities last November. Advocates praised the Department of Public Health (DPH) for its efforts to solicit input from patients and concerned citizens from across the state through a series of Listening Sessions that began in February and concluded in April.

“DPH should be commended on the process it established to hear from hundreds of stakeholders as it crafted the regulations that were approved by the Public Health Council today,” said Matthew J. Allen, director of the Massachusetts Patient Advocacy Alliance (MPAA). “These regulations demonstrate a dedication to ensuring safe access for patients while including strict controls to prevent misuse of the system. Regulations require that doctors complete a full clinical check up before issuing a recommendation, and recommendations expire after one year. No use of medical marijuana will be allowed on MMTCs premises, and they and will face restrictions on advertising and signage.”

MPAA is a coalition of medical marijuana patients, their family members, medical professionals, and public health groups advocating for safe access to medical marijuana for patients with a doctor’s recommendation. MPAA helped bring the medical marijuana ballot initiative to the voters, and has since been working to ensure that patients have a voice in implementation.

Peter Hayashi, a board member of the organization, is one of the many advocates who testified at the six sessions held by DPH. He is a former clinical neuropsychologist and was a member of the Harvard Medical School Faculty until 2000. Dr. Hayashi suffers from condition called allodynia, which causes a type of neuropathic pain resistant to available medications.

“This is an improvement on the first draft. I’m glad the regulations have increased the financial hardship income threshold.” he said. “This means that more patients will be eligible to receive their medicine from treatment centers at discounted rates, which is very important since medical marijuana is not covered by insurance.”

The regulations approved today will go into effect on May 24. They allow the department to establish a competitive application process for non-profits seeking certifications that will permit them to operate. DPH is required to certify at least 14, but no more than 35, medical marijuana treatment centers to open by January, 2014.

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CONTACT: Matthew J. Allen, Massachusetts Patient Advocacy Alliance, mjpatients@gmail.com, 508.410.1547

BOSTON – Today the Department of Public Health (DPH) held its final public hearing on recently released draft regulations for the medical marijuana program. Patients gathered in Boston to voice their concerns.

“MPAA is very appreciative for the department’s efforts, especially their commitment to input from patients and others,” said Matthew J. Allen, director of the Massachusetts Patient Advocacy Alliance (MPAA). “DPH is very close to designing the best-in-nation program, and we are hopeful they will get there in the final regulations.” MPAA filed five pages of comments on particular aspects of the regulations.  

MPAA is a coalition of medical marijuana patients, their family members, medical professionals, and public health groups advocating for safe access to medical marijuana for patients with a doctor’s recommendation. MPAA helped bring the medical marijuana ballot initiative to the voters, and has since been working to ensure that patients have a voice in implementation. Many members commended the department for the steps they have taken to enact the law.

The New England Coalition for Cancer Survivorship (NECCS) submitted written testimony. “We are thankful that DPH is moving forward quickly but thoughtfully with implementation, so that cancer patients and survivors can have access to an effective treatment, but there are a few issues in the draft regulations that could restrict access,” said Linda Brantley, President of NECCS, in a statement, “We are concerned that debilitating has been defined too narrowly, as medical marijuana has proven effective as a preventative measure for people struggling with nausea from chemotherapy, and from some of the after effects of cancer as well, including chronic pain.”

Scott Murphy, a disabled combat veteran who spoke at the Boston hearing, echoed this concern. “I want to make sure that medical marijuana is available to my fellow service  members coming back from deployment who suffer from PTSD and other combat related  conditions. The decision about appropriate medical use should be up to doctors and patients, not restricted through regulations.” 

The department is expected to make changes to the draft regulations based on the feedback they received today. The final draft will then be sent to the Public Health Council on May 8th. If approved by the council, regulations will go into effect on May 25.

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What defines a 60-day supply? What defines a bona fide patient relationship? How tightly controlled will be the list of qualifying conditions? How will dispensaries and cultivation sites be regulated?

Those are among the questions that many hope to have answered Friday.

The draft regulations follow a series of listening sessions held in February across the state and open the door for additional public comment before they are adopted in May.

Massachusetts voters passed Question 3 — also known as “An Act for the Humanitarian Medical Use of Marijuana” — in November. Advocates for and against the use of marijuana as medicine have offered their input to the DPH as it has worked to create its draft regulations.

Among those waiting are George and Allison Jones of Rutland. Mrs. Jones, a registered nurse, was nearly crushed to death in an accident three years ago when a car landed on top of her as she helped the victim of an accident. She was left with myriad broken bones — including her spine and pelvis, which were broken in two places, and nearly all of her ribs — and a laundry list of high-powered drugs to manage the pain: morphine, OxyContin, oxycodone, Dilaudid and Percocet, to name just a few.

“I was put in the precarious position of being both her spouse and her caregiver,” Mr. Jones said, adding that he managed dispensing her pills. “When you see someone that you love hurting that badly, it is so hard to say you have to wait another two hours. And the last thing I wanted to see was her hooked on prescription drugs.”

They were drugs Mrs. Jones wanted to get off of, especially after a drug interaction caused her kidneys to fail.

She turned to medical marijuana and, in a year’s time, is now free of all prescribed controlled substances.

“I was so impressed with how much better I felt physically and emotionally now that all of these chemicals were out of my body,” Mrs. Jones said. “It has helped me so much that I would like to see people have that option. I know it may not be for everyone, but I have been helped so much by it.”

Mrs. Jones said she is happy to see the state moving quickly in issuing its regulations and hopes doctors will be comfortable recommending medical marijuana to their patients.

Meanwhile, Dr. Richard V. Aghababian, president of the Massachusetts Medical Society, said there is still much research to be done to prove the efficacy of the marijuana leaf as medicine. But now that this is a law, he said, the Massachusetts Medical Society is working with the DPH to provide patients with the relief they need as well as protecting doctors who are still taking a risk if they support marijuana treatment for their patients. This is because it still violates a federal law.

“Doctors are in a quandary, “Dr. Aghababian said. “Doctors are being put in a position to do something that a patient is asking them to do, but it puts the physician in a position that violates federal law. I am not saying they shouldn’t do that, but those who do so, do it with some risk.”

While the medical society remains opposed to the recreational use of marijuana, it did adopt new policies for the clinical use of marijuana in December, and supports a “responsible implementation” of the law.

“We want to make certain that the process is based on sound scientific decision-making and the physicians issuing the certification have done a thorough work-up on the patients for which they are issuing a certification,” Dr. Aghababian said. “We want to make sure it is in the hands of the people who need it according to the law.”

Dr. Aghababian said the medical society will look for the regulations to ensure that safeguards are in place to prevent doctor- and prescription-shopping, and that marijuana will only be used for medicinal purposes and not diverted to teenagers or resold.

In addition, the medical society would prefer that the marijuana plant undergo the same rigorous testing that other botanical drugs are subject to before it is widely available.

“There are medical applications that appear, anecdotally, to be beneficial, but that is so antithetical to the approach we use with biologicals in that they have to go through a course of rigorous study to make sure there are no long-term adverse effects,” Dr. Aghababian said. “We are certainly willing to work with the DPH to figure out how all this will work. Like anything, there is a risk-benefit assessment. If the potential benefit outweighs the risk, then we’d like to have that substantiated by science.”

Dr. Aghababian added that as recently as a few weeks ago, the federal Drug Enforcement Administration wrote that it would not reconsider reclassifying marijuana and that it would remain a Schedule I drug, meaning one classified as having a high level for abuse and no accepted medical use in the United States.

“The government doesn’t feel that there is sufficient research to justify using botanical marijuana,” Dr. Aghababian said.

The Massachusetts Medical Society will continue to offer its comments and concerns throughout the comment and hearing process.

The Massachusetts Patient Advocacy Alliance — the group with which the Joneses are involved — plans to continue to work with patients as well as educating the public on what it sees as the medical benefits of marijuana.

“We want to ensure that patients continue to have a voice,” said Matt Allen, executive director of the Massachusetts Patient Advocacy Alliance.

The Public Health Council will formally present the draft regulations to the Department of Public Health for discussion and feedback. A public hearing is scheduled for April 19, and the public comment period will close on April 20.

The Department of Public Health is then expected to act on the revised regulations, which are expected to go into effect on May 24.

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The regulations say patients must have a debilitating condition — defined as causing weakness, wasting syndrome, intractable pain or nausea, or impairing strength or ability and limiting major life activities — to receive written certification from their doctor to buy the drug.

The rules also list qualifying conditions, including cancer, glaucoma, HIV/AIDS, hepatitis C, and amyotrophic lateral sclerosis, or ALS, but ultimately allow doctors and their patients to decide what other conditions would qualify for treatment.

Dr. Lauren Smith, interim public health commissioner, said her agency heeded the many requests from patients who testified during public hearings in February that the decision is best left to doctors and their patients.

“We shifted the focus away from the disease and more appropriately to how that disease affects the patient,” Smith said during a teleconference with reporters.

Voters in November approved a ballot referendum that legalized marijuana for medical use, but the measure left it to the health department to issue regulations that would implement the law.

The referendum allowed patients to possess up to a 60-day supply of marijuana for personal use, but did not define the specific amount. The draft regulations define that supply as up to 10 ounces in a 60-day period. The department said it took into account the “best practices” from 17 other states that have legalized marijuana for medical use in crafting Massachusetts’ proposed regulations.

But some advocates said 10 ounces may not be enough to address the pain and other symptoms of some patients.

Whitney Taylor, field director of the American Civil Liberties Union of Massachusetts, noted that Washington state, which adopted a medical marijuana law more than a decade ago, allows patients to possess up to 24 ounces of marijuana in a 60-day period.

“Washington state has had all these years of experience, and they have a policy statement on why they chose 24 ounces, so why do something else?” she said.

Another patient advocacy group, Americans for Safe Access, said it found the rules “generally acceptable,” but is concerned about several of the new provisions, including one that would require physicians to undergo mandatory training before being authorized to recommend marijuana to their patients.

The group said in a statement that this might “chill physician participation in the program and make it more difficult for patients to obtain a recommendation.”

The 45 pages of rules also would require applicants wishing to open a medical marijuana treatment center, known as a dispensary, to be organized as a nonprofit and to operate both a cultivation and dispensing facility. No wholesale distribution of marijuana products would be allowed.

Scott Hawkins, who heads a Boston consulting firm that has advised industry and elected officials on medical marijuana issues in several states, said Massachusetts’ draft rules are unlike those in many other states because they allow dispensary owners to cultivate their crop at an alternate in-state site.

“It allows for Western Massachusetts to participate by having a greenhouse operation,” Hawkins said. “This allows for greater economics in production, making it less expensive to produce, which would allow patients, in theory, to receive less expensive medicine.”

The regulations require dispensary applicants to document that they have at least $500,000 in an escrow account, a high hurdle particularly for nonprofit organizations that typically rely on federal funding, said Wayne Dennison, an attorney at the Boston firm Brown Rudnick.

Despite the existence of marijuana dispensaries in 17 other states, federal authorities do not recognize the them as legal operations, making them potentially subject to criminal prosecution.

“Any nonprofit that is pretty heavily federally regulated would likely run away from trying this because of their funding source,” Dennison said.

Massachusetts regulators said they intend to “minimize home cultivation” through a variety of approaches, including requiring the industry to provide and finance discounted rates for low-income residents at all dispensaries, allowing “secure home delivery where necessary,” and encouraging patients’ personal caregivers to pick up products in lieu of growing marijuana at home.

“In this proposal, we have sought to achieve a balanced approach that will provide appropriate access for patients, while maintaining a secure system that keeps our communities safe,” said Smith, the interim commissioner.

Addressing concerns raised by many substance abuse prevention advocates, the rules severely restrict marijuana access to patients under age 18, requiring guardian approval and certification by two physicians, one of them a pediatrician or pediatric specialist. These younger patients would only be certified to receive marijuana if they had a “life-limiting illness, likely to result in death within six months,” according to the rules.

Smith’s department also recommends strict rules for dispensary advertising, allowing no illuminated signs or signs larger than 16 by 18 inches outside the buildings. The rules prohibit the dispensaries from advertising their prices outside their facilities, and will not allow the sale of any “promotional gifts, such as T-shirts or novelty items,” bearing any symbols or references to marijuana or marijuana products.

The department said it will accept written comments immediately from patients, interested parties, and the public at large. On April 10, the department will present the draft regulations to the Public Health Council, an appointed body of physicians, academics, and policy makers that is responsible for reviewing the department’s recommendations and approving final regulations.

On April 19, public hearings will be held in Northampton, Boston, and Plymouth, and on April 20 the public comment period will close, the department said.

State Representative Jeffrey Sánchez of Boston, House chairman of the Joint Committee on Public Health, said in a statement that the public should realize the rules issued Friday are only a “midpoint” of a long regulatory process.

“There is still time for citizens to weigh in on this proposal, and I encourage them to do so through the department’s public hearings or through written comment,” Sanchez said.

The Public Health Council is scheduled to vote on final rules May 8, and if approved, those rules would go into effect May 24, the department said.

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Beacon Hill’s Eric McCoy, 59, has multiple sclerosis. His upper body is totally mobile, but he has difficulty moving his legs. He navigates the winding, steep streets of his neighborhood with the help of a motorized chair.

McCoy’s apartment is lined with wooden and brass railings, which he uses to lift his body and move around. And just as helpful for mobility, McCoy said, is Marijuana.

“Medical marijuana allows me to live my life everyday,” McCoy said. “It relieves muscle spasms in my legs, allows me to go from point A to point B in my apartment. And that’s what I need to do in order to live properly without assistance.”

McCoy inhales from a vaporizing device that heats marijuana and releases active ingredients. He takes a few other medications — injections and pills — for other MS symptoms, such as fatigue. But he has concerns about the side affects associated with the pills.

“I’ve don’t take anything but marijuana for my leg problem — stiffness, spasms,” McCoy said. “I started using medical marijuana 17 years ago based on the fact that I’d heard other folks with MS were using it and it was helpful. And I’d never used marijuana.”

McCoy inhales from his vaporizer several times a day, as needed, he said. He doesn’t think it has much of an effect on his brain or his mood. He buys marijuana on the black market, and has to leave his apartment building to do so. But now that medical marijuana is legal in Massachusetts, McCoy wants to grow it at home. That’s what prompted him to testify before the state Department of Public Health on Thursday.

“Hello, my name is Eric McCoy and I have MS,” McCoy told the DPH Thursday. “I’m also here because I have difficulty traveling and I request that MS patients should have the hardship cultivation ability.”

But the National Multiple Sclerosis Society was not represented at the hearing. In fact, the organization is not taking a stance on medical marijuana.

“The society does not have a position on medical marijuana,” said Steve Sookikian, spokesman for the New England Chapter of the National Multiple Sclerosis Society. “We don’t support or oppose the issue. The society has funded research into the use of orally administered cannabinoids. And we believe more research is needed to determine their efficacy, and particularly their effects on spasticity and pain without cognitive impairment.”

Cancer patients are among the most vocal users of marijuana for medical reasons. But the American Cancer Society does not advocate inhaling marijuana or even legalizing it. Like the MS Society, they’re calling for more research into the benefits of cannabinoids.

But those who are testifying at the hearing speak passionately about the use of marijuana to calm and lessen pain related to cancer, nerve damage, Parkinson’s disease — even post-traumatic stress disorder.

Newton’s Scott Murphy, an Iraq War combat veteran, argued for PTSD’s inclusion.

“As you might be aware, we’re losing one soldier a day,” Murphy said tearfully. “If medical marijuana could help one person with PTSD, I hope you would consider that.”

“People very much want their condition not to be excluded, recognizing that only a specific number of conditions were mentioned by name in the statute,” said Lauren Smith, interim commissioner of the Massachusetts Department of Public Health.

She’s been at the hearings and she says the state has received so much input – from patients, pharmacists, doctors, lawyers and lawmakers – it may not make the May 1 deadline to craft regulations.

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Meanwhile, the DPH held its first public medical-marijuana “listening session” on February 13 in Worcester, and a second one the next day in Roxbury. A third is planned for next week in Holyoke. These informal listening sessions aren’t meant to take the place of the public hearings required by law, which have yet to be scheduled. But along with Patrick’s interview, the sessions are providing the first glimpse into what has been an opaque process — and they have already drawn an emotional response from both advocates and DPH Interim Commissioner Dr. Lauren Smith.

On the morning of Valentine’s Day, Smith arrived at Roxbury Community College and took a seat at a long table next to her senior staff. Initially, Smith said she’d be leaving the session early — but she ended up staying for the duration.

On flyers distributed outside the meeting room, the DPH listed specific issues for speakers to address, including patient eligibility, debilitating medical conditions, guidance for physicians, treatment-center operations, and hardship cultivation registrations. Law-enforcement officers, businesspeople, lawyers, and medical professionals came prepared with targeted talking points.

But some patients’ voices cracked as they tried to squeeze years of physical suffering into three-minute speeches.

A military veteran shared concerns about VA doctors not being able to issue medical-marijuana recommendations. He broke down while speaking of PTSD, and Smith appeared to wipe her eyes along with him. The panel took notes, nodded often, and thanked the public for coming out. But while the regulatory drafting process is slightly less murky, it’s still unclear exactly who will be in charge of the DPH program.

“We haven’t made a final decision yet on what bureau or department within DPH will supervise it — but we’re probably pretty close,” says Dave Kibbe, communications director for the DPH. “As you can see, we’re working diligently moving the process forward.”

Even with emotions running high for the course of the event, it was never a scene from the Freedom Rally. Advocates came dressed for a day in court. Patient coalition leaders and members also seized the opportunity to be heard, sharing deeply personal accounts of suffering and the search for relief. Members of the Massachusetts Patient Advocacy Alliance and the Coalition for Responsible Patient Care repeatedly urged the DPH not to limit qualifying conditions, or restrict hardship-registration requirements — as had been recommended in a bill floated by State Senator John F. Keenan.

“Listing which conditions are worthy of receiving medical marijuana and which aren’t would be a form of oppression and judgment . . . it should be between ourselves and our doctors,” said John Kelly, a disability-rights advocate. “Don’t put yourself into the position of a moral judge.”

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The Feb. 27 informal hearing, scheduled for 1:30 to 4:30 p.m. at Holyoke Community College’s Kittredge Business Center, is one of three “listening sessions” held by DPH as it drafts regulations for the state’s new medical marijuana system.

Massachusetts voters approved the legalization of medical marijuana in November by a margin of 63 percent to 37 percent. While the new law went into effect on Jan. 1, DPH has until May 1 to draw up its regulations.

The three sessions—including ones held last week in Worcester and Boston—are opportunities for the public to weigh in on those regulations. In particular, DPH says it’s looking for public input on what medical conditions would make a patient eligible for medical marijuana, training for prescribing physicians, security measures and monitoring of medical marijuana dispensaries, regulation of food products containing marijuana, and standards for allowing patients who demonstrate a hardship to grow their own marijuana. DPH says its aim is to “put in place a system that is right for Massachusetts, ensuring both appropriate access and safe and secure communities for our children and families.”

The state is also accepting written comments through Feb. 28. They can be sent by email to MedicalMarijuana@state.ma.us or by letter to the Department of Public Health, Attn: Medical Marijuana Listening Sessions, 250 Washington St., 2nd Floor, Boston, MA 02108.

The Worcester Telegram & Gazette reported that speakers at the Worcester session included city officials who expressed concern about the potential negative effects a dispensary could have on the community, as well as the city’s health commissioner, who said there are no dosing standards for marijuana and no sufficient evidence that it’s medically effective. That’s also the position of the Mass. Medical Society, which opposed last year’s medical marijuana ballot question and has called on the federal Drug Enforcement Agency to reclassify marijuana to allow more scientific study of its medical efficacy.

Northampton attorney Dick Evans, a long-time advocate for marijuana law reform, attended the Feb. 13 Worcester session. In written comments he shared with the Advocate, Evans reported that about 250 people attended, along with several DPH staffers “with dutifully blank faces.”

Evans wrote that the “overwhelming majority” of people in attendance “urged the DPH to adopt regulations to carry out the will of the voters in a timely fashion so that this medicine will be available to qualifying patients without delay. … Speaker after speaker told heart-rending stories of weaning themselves off prescription narcotics, the side effects of which were devastating to their health, when they ‘finally’ turned to medical marijuana.”

Attendees who spoke out against medical marijuana included “the usual suspects, zealous defenders of prohibition and familiar opponents of reform,” said Evans, who left the session confident that medical marijuana “enjoys solid public support.”

Matt Allen, executive director of the pro-medical marijuana Mass. Patient Advocacy Alliance, said the listening sessions show that DPH “is moving forward with crafting thoughtful and effective regulations.” His group, he told the Advocate, is “working to bring forward patients, their family members, medical professionals and public health groups to ensure they have a voice in the process, and that the final regulations meet the needs of patients suffering with serious health conditions.”

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The District 2 councilor was the first to speak out in opposition to Councilor-at-Large Konstantina B. Lukes’ effort to stonewall the citing of a medical marijuana dispensary in the city and thus thwart the will of voters who sent a clear message that sick people should have access to pot.

“It is far too premature for us to be making any decision on this because the state hasn’t even yet come out with its regulations and criteria,” Palmieri noted.

The full council agreed and voted 8-2 on Tuesday to essentially kill the resolution offered by Lukes, but she’s not the only official in Massachusetts who wants to restrict or even ban drug dispensaries in their communities before medical marijuana becomes legal next month.

The new law to legalize medicinal pot was approved by more than 60 percent of the voters, but many misguided officials throughout Massachusetts appear eager to maintain the failed war on drugs, even as their constituents voice a growing acceptance of pot as medicine and even as a recreational substance.

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The new law, which voters approved by a 63-37 margin in a statewide referendum, allows for 35 centers across the state where marijuana can be grown and dispensed; the law calls for at least one, but no more than five, in any single county. Those facilities must be approved by the state Department of Public Health, which will oversee their operation.

But the promise of DPH involvement hasn’t stopped local politicians from rushing into the fray. Some are seeking to ban dispensaries altogether. Votes to do that have already happened in Saugus, Wakefield, Reading, and Peabody, while Melrose is also contemplating a ban. Others want to forbid dispensaries in downtowns or in areas that have churches, schools, or parks. Approaches like that are under consideration in Woburn and Quincy.

Before they take effect, such changes will have to be reviewed by Attorney General Martha Coakley, whose office is charged with deciding whether they are consistent with the state’s constitution and laws. And she will rightly consider which of these local bans are legally out of step with a measure that was passed by a sizable majority of voters.

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