By Gillian Mohney for Healthline
Republican Senator Orrin Hatch of Utah has introduced a bill to relax medical marijuana research regulations.
“On the one hand, it’s a political victory. I think having a bill that even touches on the subject from Orrin Hatch is considered a win, but on the other hand, we’re of the mind the research is there, the research is done.[Medical marijuana] programs have been around for 20 years. A research bill was more appropriate in the late 1990s and early 2000s.” - David Mangone, JD
Medical marijuana is now legal in 29 states, but the drug’s various effects on the human body are a mystery in many ways.
Federal regulations have made it difficult for scientists to study marijuana’s effects on human health.
But Sen. Orrin Hatch, R-Utah, may finally help make it easier to understand what exactly marijuana does to the body.
Hatch, who’s against any recreational use of marijuana, introduced a bill earlier this month aimed at relaxing some of the stringent regulations that affect the study of medical marijuana.
“Under current law, those who want to complete research on the benefits of medical marijuana must engage in a complex application process and interact with several federal agencies,” he said. “These regulatory acrobatics can take researchers over a year, if not more, to complete. And the longer researchers have to wait, the longer patients have to suffer.”
Hatch said he was moved to introduce the bill in part due to the ongoing opioid epidemic and the fact that he’s heard from constituents in Utah who want nonnarcotic pain alternatives.
“Medical marijuana is just one such alternative. And after careful, deliberative thought, I’ve concluded that it’s an alternative worth pursuing,” he said.
Hatch’s bill focuses on making it easier for scientists and doctors to study medical marijuana in laboratory settings.
Difficulties of studying medical marijuana
While 29 states and Washington, D.C., have legalized medical marijuana, it’s classified as a schedule 1 drug.
The Drug Enforcement Agency (DEA) defines schedule 1 drugs as having “no currently accepted medical use and a high potential for abuse.”
As a result of this classification, researchers and scientists still face difficulty in getting approved substances to study in a laboratory setting.
They also face a daunting approval process to get government-approved medical marijuana.
Researchers who want to study if these drugs can have a medical use face extra scrutiny and regulations from federal agencies, including the DEA, the U.S. Food and Drug Administration (FDA), and the National Institute on Drug Abuse.
These regulations include applying for a special license from the DEA to work with the material, outfitting their laboratory with special safety features, and waiting for marijuana to be grown by the single government-approved grower of medical marijuana.
Dr. Daniel Friedman, an associate professor in the department of neurology at NYU Langone Medical Center, has studied the effects of a marijuana component called cannabinoids on people with epilepsy.
He said the process to start the study involved getting a “one ton safe” and going through multiple checks with federal officials.
“It certainly was challenging, and you know it obviously helped that there was a pharma company who was able to pay for some of the logistical challenges,” he told Healthline.
Friedman said these extra requirements mean researchers may seek backing from a pharmaceutical company for their research. As a result, this affects the kinds of diseases they’re willing and able to study.
“It does become problematic for investigators who are not interested in studying a particular disease state or a disease state that is not in line with what a [pharmaceutical company] is interested in,” he said.
Hatch’s bill, which is co-sponsored by Sen. Brian Schatz, D-Hawaii, would make a variety of changes to the way medical marijuana is regulated for researchers.
These changes include requiring the attorney general to respond to medical marijuana producer applicants within 30 days, not limit the number of manufacturers and distributors who can apply, and meet demand from researchers for medical marijuana.
In addition to Hatch’s bill, another bill introduced by Sen. Cory Booker, D-N.J., would amend federal law to allow states to set their own medical marijuana policies.
Dispensary marijuana vs. laboratory marijuana
Nehal P. Vadhan, PhD, and an associate investigator at the Feinstein Institute for Medical Research in New York, said since there’s only one current supplier of medical marijuana, the products available to study may not match what’s in a local dispensary, which are more plant-based.
If researchers want to study aspects of marijuana other than THC, “you're stuck with what the government produces, which doesn’t have the greatest variety,” he told Healthline.
Advocacy groups have been trying to raise awareness of restrictions on researchers for years. Some said that while the progress is helpful, it doesn’t go far enough.
David Mangone, JD, legislative analyst for the medical marijuana advocacy group Americans for Safe Access, said the fact that Hatch — a Mormon Republican from Utah — had introduced the bill counted as a victory.
“On the one hand, it’s a political victory,” he told Healthline. “I think having a bill that even touches on the subject from Orrin Hatch is considered a win, but on the other hand, we’re of the mind the research is there, the research is done.”
Mangone said there’ve been enough studies that marijuana has some health benefits. It should be clear it has some medicinal benefit.
“[Medical marijuana] programs have been around for 20 years,” he said. “A research bill was more appropriate in the late 1990s and early 2000s.”
Last year, after pressure to change the marijuana classification, the DEA announced they’d allow more producers to grow medical marijuana for research.
However, they didn’t change marijuana’s classification as a schedule 1 drug.
A DEA spokesman said since that announcement, they received 25 applications from potential growers, but the Justice Department has currently suspended those reviews. It’s unclear if there’ll be more producers of medical marijuana.
Still a roadblock
Natalie Ginsberg, policy and advocacy director of the Multidisciplinary Association for Psychedelic Studies (MAPS), said they “certainly are excited and encouraged… on doing further cannabis research.”
Researchers affiliated with MAPS are currently working on a study to see if marijuana can help veterans living with post-traumatic stress disorder (PTSD).
However, Ginsberg said even with the legislation, they still have a major roadblock.
The FDA requires that drugs used in a phase III trial be the same as what’s brought to market.
With such a limited supply available to researchers, it’d be difficult for some marijuana products to get through such a drug trial. Additionally, since NIDA can't be contracted by private companies to grow cannabis for the public, researchers can't use their product in phase III and market sale.
“It is something to consider that NIDA is not able to grow the different strains that we requested,” Ginsberg told Healthline. “You have to use the same source of medicine for phase III that you need to use for sale.”
For Friedman, who plans to continue studying how marijuana products affect people with epilepsy, he said his biggest concern is that the restraints on medical marijuana research leave doctors without the ability to give good advice to patients, who want to get medical marijuana from their local dispensary.
“I think it’s important to get the conversation going, especially in the context of this rapidly growing access in all the states,” he said.
