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A new bill could completely change cannabis research


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Thor Benson / Cannabis News Box Contributor

If anyone knows how hard it is to study the medicinal benefits of cannabis, it’s Dr. Sue Sisley.

Sisley is a physician who has worked with veterans for over 20 years and has been studying how cannabis could help treat Post-Traumatic Stress Disorder (PTSD). Sisley has dealt with burdensome regulations, a DEA and FDA that are not nearly as cooperative as they should be and much more. Possibly the worst part has been having to use the atrocious cannabis the government supplies for research.

“It’s very sub-optimal material,” Sisley told Cannabis News Box.

There is some hope, as Sen. Orrin Hatch (R-Utah) recently introduced a bill that would help make it easier to research the benefits of cannabis. It would increase the amount of cannabis available for research and get rid of some of the regulations that make research so difficult, meaning there would be less steps involved to get started on research. Hatch said when he introduced the bill that he is staunchly against people using cannabis socially, but he thinks there could be medicinal reasons to use the drug.

“It’s high time to address research into medical marijuana,” Hatch said, attempting to be funny. “Our country has experimented with a variety of state solutions without properly delving into the weeds on the effectiveness, safety, dosing, administration, and quality of medical marijuana.”

One of the biggest problems researchers face is the government only allows them to use cannabis grown by a National Institute on Drug Abuse (NIDA)-supported facility at the University of Mississippi. This is often referred to as the “NIDA monopoly.” Like I said earlier, their cannabis is not very good.

“The cannabis from the University of Mississippi—scientists have held that this cannabis is obviously sub-standard, and we worry that the quality of this cannabis may have been harming efficacy studies on cannabis for years now,” Sisley said. “You wonder why patients, especially veterans, are reporting such robust responses to cannabis, yet the efficacy trials aren’t baring that out completely, and we think that’s because of the quality of cannabis we’re forced to use for controlled trials is not representative of the real world.”

The DEA announced it would end NIDA’s cannabis monopoly last year, but no changes have occurred since the announcement. According to a Washington Post article from last month, that appears to be because Trump’s Justice Department won’t allow it.

Furthermore, the NIDA cannabis is only allowed to be used for academic research, so although Sisley will be ready to start phase 3 trials in the next couple years, there is no cannabis that’s legally allowed to be used for phase 3 trials. That’s been baked into laws surrounding NIDA cannabis for decades. This new bill would help fix that.

“From our perspective, the most important thing is being able to put cannabis through the entire FDA drug development process,” Sisley said. “That’s something we can’t do right now, because we don’t have a study drug for phase 3 trials. NIDA cannabis from the University of Mississippi cannot be used for phase 3 trials, so that effectively shuts down any effort from any scientist who wants to put it through the entire FDA drug development process. There’s no federally allowed cannabis for phase 3.”

Hatch’s bill would expand the number of growers that can cultivate research cannabis, and they would potentially provide better cannabis than what NIDA has been producing. Sisley is hoping to be able to use a wide variety of cannabis strains for phase 3 trials.

Dr. J. Hampton Atkinson, co-director of the Center for Medicinal Cannabis Research at the University of California, San Diego, said he is hopeful that this bill could help speed up progress in medical cannabis research.
 
“It might some day help streamline and expedite the approval process for research and expand the range and supply of cannabis products available for testing,” Atkinson told Cannabis News Box. “As it now stands it takes 12-18 months for protocols to gain approval from the FDA, NIDA, and the DEA. And many more months before NIDA ships the material requested for study. So any movement on either front would be welcome.”

Until researchers have access to as much cannabis as they need, the quality they need and more, real medical cannabis research is never going to get done. If the government is serious about medical cannabis, then it needs to make research far easier to accomplish.

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