Research is key to Minnesota's budding medical pot program

Minnesota is not the first state to legalize marijuana, but it is the first to include medical research as a key requirement on its complicated and uncharted path to turning an illegal recreational drug into a treatment for illness.

Now that the pitched legislative debates over whether to legalize marijuana at all are over, there is an ambitious timetable to put the new law into practice. The Minnesota Department of Health has one year to hire an administrator, choose two in-state companies who will manufacture and dispense marijuana products at up to eight locations, and draft safety guidelines for patients who are under the influence of medical cannabis.

State officials must also gather and analyze existing research on safety and dosing, and create a registration system that allows doctors to certify that their patients have qualifying illnesses. Then patients apply to the state for access to medical marijuana.

Other states have shown that such a registration system is "doable," said Manny Munson-Regala, an assistant commissioner for the state health department. But none have taken on Minnesota's unique and somewhat controversial plan to study each and every patient to see if marijuana works and produces any harmful side effects. In short, Minnesota is designing a system from scratch that simultaneously serves and learns from marijuana recipients.

"The quid pro quo is, yes, you get access to medical cannabis, but you have to report some data," Munson-Regala said.

Minnesota has only legalized marijuana in oil and pill forms and will not allow people to smoke it or grow their own marijuana plants for consumption. It also has excluded marijuana usage by patients suffering from neuropathic pain or post-traumatic stress disorder who can receive it in other states. It will be allowed for eight specific conditions such as cancer, glaucoma and seizure disorders.

Studying how patients fare with various forms of marijuana could address difficult questions about doses and side effects that persist in all 21 states that legalized medical marijuana before Minnesota, Munson-Regala said. The goal is to find out "what works and what doesn't work, what's safe and isn't safe."

A novel system

Addressing them in a structured, science-based way while also launching a novel legalization system in one year will present challenges, though. One dilemma is whether to restrict the doses that are dispensed to patients for these conditions.

Standardizing the doses could produce more consistent results about marijuana's effectiveness for various conditions, but there is little solid evidence about where to start. And any restrictions could frustrate patients who benefit from lower or higher doses than recommended.

Darren Forsythe celebrated Minnesota's passage of a medical marijuana law earlier this year. Nevertheless, the Bloomington man is planning to sell his house and move to Colorado over concerns that Minnesota's research requirement will force him to take too large a dose.

Forsythe already takes a drug that is a synthetic form of THC, the chemical agent in marijuana believed to have therapeutic benefits, but only occasionally to help him sleep or relieve muscle spasms. He worries the state could require him to take a dosage that would be too high and interact with other pain relievers and medications he takes.

"I don't like the idea of being told 'You get to take the strong version,' " he said, "'because we want to know what happens to you when you take it.' "

The research component was in part a concession so that the state's doctors, via the Minnesota Medical Association, wouldn't block the medical marijuana legislation. The doctors' group had expressed a variety of concerns, including that medical marijuana hasn't been subject to the same kinds of rigorous research studies that are used to gain U.S. Food and Drug Administration approval for pharmaceutical drugs.

Minnesota still won't accomplish that — not unless the state designs a true scientific experiment by giving actual marijuana to some patients and a placebo to others. And that isn't planned.

Still, gathering detailed observational data about how every Minnesotan using medical marijuana fares will be valuable, and could inform the rest of the nation about the best products and the proper dosages to treat conditions, said Dr. David Thorson, chairman of the state medical association board. "We want to see this paired with thoughtful clinical studies that can look at dosing, that can look at improvement rates."

Exactly how much information will be reported has yet to be decided, but doctors will be required to provide some level of health information to the state while their patients are receiving medical marijuana, and will need to recertify their patients each year.

Whether patients must submit to additional clinical exams or tests is also unknown, as the state weighs the benefit of thorough information for research with the demands on patients.

"There's a tension between the needs of the researchers — they want everything — and the reality of being patients … and how much a pain reporting is going to be for them," Munson-Regala said.

The absence of details about the research concerns some patients and pro-marijuana advocates. Heather Azzi of Minnesotans for Compassionate Care worries that doctors won't want to certify patients as having conditions treatable with marijuana if the end result is a paperwork burden. Then patients might have to waste time and money visiting multiple doctors to find one who will certify their conditions, she said.

Cost a factor

Minnesota is spending $2.9 million next year to start the registry, and about $1 million per year after that to maintain it and continue the research project. User fees of $200 per patient will help fund it, but Azzi wondered who will bear the cost if patients are required to participate in additional medical exams in order to provide data that researchers need. "This is not something that is going to be covered by medical insurance," she said.

Thorson said he would be willing to certify patients' qualifying conditions, but other doctors aren't so sure. Some health system officials worry they might lose their grants from the federal government, which currently deems marijuana an illegal controlled substance. Allina, Children's, HealthEast and Fairview said their health systems had not yet set any policies one way or another.

There are patients, however, who say the research is worth the price. Kristy Kargel hopes to use the state system next year to access medicinal marijuana that will help her now 9-year-old daughter deal with frequent seizures.

She was already prepared to move to Colorado — possibly splitting the family temporarily while her husband and youngest daughter remained in Minnesota — so providing data for medical research hardly seemed like a burden.

"I'm all for research," the Stillwater mother said. "I mean, we've tried over 21 medications that have failed … I'm willing to put in as much time and effort as we need."

Jeremy Olson • 612-673-7744