Posted: May 15, 2018
How to deal with marijuana is a major national policy question. Although marijuana remains illegal under federal law, 29 states allow medical marijuana and another eight allow recreational marijuana. Policymakers routinely debate questions such as the impact of marijuana on opioid addiction, the drug's safety, and the effects of marijuana on driving.
But experts say factual information is hard to come by because of a lack of scientific research.
Now, Massachusetts may have the potential to change that -- if researchers can overcome the hurdles.
"Given the investment in technology, the staggering array of biotech and scientific expertise, it virtually ensures Massachusetts will be an important player," said Staci Gruber, director of MIND, Marijuana Investigations for Neuroscientific Discovery, at McLean Hospital in Belmont.
The state law legalizing marijuana authorizes licenses for marijuana research facilities, defined as an academic institution, nonprofit or corporation. Such facilities are allowed to cultivate or buy marijuana for the purpose of conducting research. A research facility cannot sell marijuana. Applications for research facility licenses opened May 1.
McNabb is CEO and co-founder of the Cannabis Community Care and Research Network, a Somerville-based research start-up formed in January 2017. She spent the last year urging state lawmakers to adopt a research agenda for cannabis. Her organization runs education and networking events on cannabis science.
McNabb said the organization plans to do its own research. It also aims to create an online portal where researchers can share findings and data.
"Now, someone publishes one study on cannabis and opioids, another looks at youth prevention, they're all in silos," McNabb said, adding that a place for open sharing of data could "drive science and evidence-based practices" and inform policy.
It remains unclear how this will impact Massachusetts, which legalized marijuana in 2016.
But any marijuana research facility will face challenges, mostly related to marijuana's federal classification as an illegal drug.
For one, federal law governs clinical trials. The only way to scientifically test marijuana's effects on people is by getting approval from a federal agency and using marijuana grown under National Institute on Drug Abuse auspices at the University of Mississippi.
But researchers say the marijuana grown by government researchers is not the same as what's available on the market. The plants generally have less THC than commercially available marijuana, although NIDA has recently broadened its inventory that is available for research. The products available for research are mostly flower rather than oils, tinctures or edibles, all of which are available in state-legalized markets.
"The products the government grows and oversees for research may not have any bearing on products patients are using in the real world," said Gruber, who has received research funding from NIDA.
In August 2016, the U.S. Drug Enforcement Agency announced that it will allow growers to register with them to produce marijuana for research purposes.
Gruber has been researching recreational marijuana for 25 years and medical marijuana for around three years.
She said there are "creative" ways of studying the effects of cannabis on individuals, despite the federal rules. For example, she can ask questions of patients who receive medical marijuana from a Massachusetts dispensary. And, researchers can create their own oils or edibles from NIDA products. But Gruber said it would be easier if the federal government allowed her to partner with a state grower or dispensary.
She said the restrictions create a Catch-22. "It's difficult to change laws without empirically sound data, but you can't do clinical trials that represent what most people are taking," Gruber said.
Harvard Square neighbors sued Healthy Pharms for violating the federal RICO statute by operating a state-licensed medical marijuana dispensary.
It is not always easy to get federal approval to acquire marijuana. UMass Amherst professor of plant biology Lyle Craker started applying for a license from the federal government to study marijuana in 2002. He wants to study the properties of the plant to see what medicinal effect it has. His application was denied, and he has reapplied every year since.
"I keep requesting one, but they don't even answer me anymore," Craker said. "Before, they just said no."
Under the new state law, Massachusetts labs will be allowed to acquire marijuana from local growers to use in tests that do not include clinical trials.
But researchers must also find funding. While scientific research is often funded by government grants, there are few grants available for cannabis research. Universities can be reluctant to pursue marijuana research because it could jeopardize their federal funding.
McNabb said most states that have marijuana research programs -- such as Colorado, Pennsylvania and Washington -- suffer from "a sore lack of funding."
So far, Massachusetts lawmakers have allocated just $70,000 to the Cannabis Control Commission for research.
The marijuana industry typically has not seen value in funding research, and few investors are interested. "That's our big conundrum -- who's going to fund us," McNabb said.
There have been some federal advances. The U.S. Food and Drug Administration recently took a step toward approving a marijuana-based drug for epilepsy, which would be the first marijuana-based drug ever given FDA approval.
Can Massachusetts become a leader in marijuana research?
But federal law can impede research. Michael Kahn, president of MCR Labs in Framingham, a marijuana testing facility, said his lab gathered data with a university professor -- but the university refused to publish the research because it worried about losing federal money.
Experts say there is a need for research on everything from the safety and efficacy of marijuana to the difference between using flowers and using concentrates.
"There's countless research studies that can be started very quickly, should certain restrictions be cleared," Gruber said.
Massachusetts has the potential to be a center not just for academic study but for industry. Kahn said MCR Labs is primarily a testing facility, but it also does research to inform that testing. Company researchers have examined how much THC is delivered through a vaporizer and what is the best way to keep marijuana fresh.
Manna Molecular Science CEO Nial DeMena opened the Worcester-based company in 2017. The company uses technology similar to a 3D-printer to create transdermal patches meant to deliver cannabis through the skin.
Manna Molecular Science brings unmedicated patches to different states, then sets up equipment in a cannabis company's lab and infuses the patches with the company's cannabis.
DeMena said Manna Molecular Science plans to apply for a research license, which will allow researchers to work with larger amounts of cannabis oil and test the patches with different types of cannabis.
"Right now, we can't really do a lot of hands-on work with the material," DeMena said.
DeMena said today, Israel is the world leader in exporting intellectual property related to cannabis, and he hopes Massachusetts could move into a similar role. "We have 3-D printers, biopharmaceuticals, medical devices, world class researchers, hospitals, universities...You can reach anyplace in the state within two-and-a-half hours," DeMena said. "I see (Massachusetts) as being the Israel of the U.S.
May 14, 2018
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