Major Pot Research Barrier Goes Up in Smoke

One ‘shameful’ hurdle falls, but another needs to go, researchers say.

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Dr. Sue Sisley, pictured, says elimination of Public Health Service reviews will ease barriers to marijuana research. But she and others say further reform is needed.

Dr. Sue Sisley, pictured, says elimination of Public Health Service reviews will ease barriers to marijuana research. But she and others say further reform is needed.

Medical marijuana advocates and researchers are celebrating a surprise decision by the Obama administration to scrap reviews that delayed – sometimes for years – private and state-funded research into marijuana’s medical value.

Researchers will no longer need to submit proposed pot studies to the U.S. Public Health Service for review, ending a hurdle that does not exist for research of other drugs listed as Schedule I substances – the controversial federal classification that puts marijuana alongside LSD and ecstasy.

The Department of Health and Human Services, announcing the change in a Monday notice, said the reviews – required since 1999 – are redundant. The Food and Drug Administration conducts similar vetting for pot studies as part of investigational new drug, or IND, reviews, the notice says.

“HHS is aware that this committee review is perceived to be an obstacle to non-federally funded research,” a Health and Human Services spokeswoman says. “The department expects the action announced today will help facilitate further research to advance our understanding about the health risks and any potential benefits of medications using marijuana or its components or derivatives.”

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Experts agree that the change will significantly streamline research.

Dr. Igor Grant, director of the University of California’s Center for Medicinal Cannabis Research, has been involved with seven studies that went through the process.

“It’s a process that took on average a year – as short as six months, as long as 18 months,” he says. “It was a significant burden on investigators to do this.”

Even so, Grant’s California government-funded studies fared better than some other research efforts.

Dr. Sue Sisley, formerly of the University of Arizona, says she waited three years for the Public Health Service to approve her proposed study into marijuana’s effects on post-traumatic stress disorder.

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Sisley says she received investigational drug approval from the FDA in April 2011 and mailed the proposal to the PHS the same day. They approved the study in late March 2014, she says, without requiring a single change. Part of the three-year delay was the lag time between an initial rejection and resubmission of the proposal.

More than 20,000 veterans committed suicide during the delay, Sisley says, some of whom may have been helped by the research.

“That review was designed specifically to impede marijuana research in this country,” she says. “[It] served as a shameful tactic used by opponents of marijuana research who never wanted the American citizenry to see objective data about the efficacy of marijuana.”

It was difficult to find a bad word about the change, which was floated in sweeping pot reform legislation introduced this year by Sens. Rand Paul, R-Ky., Cory Booker, D-N.J., and Kirsten Gillibrand, D-N.Y.

“I didn’t personally advocate for it, but I’m supportive,” says Dr. Stuart Gitlow, an American Medical Association delegate and psychiatrist who works with the anti-marijuana legalization group Smart Approaches to Marijuana.

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“Marijuana and its various components should be researched in the same manner as other potential medicines,” Gitlow says. “In this case, we’re well aware of risks associated with marijuana; that should be taken into consideration as we would for any other potential medicine with known associated risks.”

Though one bureaucratic berm is gone, there’s another more famous impediment still in place preventing a flood of research: the National Institute on Drug Abuse’s monopoly on growing legal marijuana.

Brad Burge, director of communications and marketing at the Multidisciplinary Association for Psychedelic Studies, or MAPS, which supports Sisley’s research, says it’s been easier for the association to research MDMA – another Schedule I drug also known as ecstasy – than marijuana. And, he says, it likely will remain more difficult to study pot.

That’s because all pot researchers must acquire the drug from a single NIDA-approved grow site at the University of Mississippi. Though medical marijuana is legal under local law in 23 states, the Mississippi plot remains the only indisputably legal source of marijuana in the country. Pot sold legally under state law remains illegal federally.

The NIDA-approved grow site, critics say, is woefully inadequate to meet research needs.

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“My own recommendation is there be licensed producers that are well-regulated in multiple locations,” Grant says. “You can’t really do it with just one source if there’s going to be a lot of research. If the research is very, very modest, obviously one source could accommodate it.”

The monopoly has kept Sisley from beginning her PTSD study, which will be done in cooperation with Johns Hopkins University and which won a grant from the state of Colorado.

“We were celebrating in March of last year thinking we had overcome the biggest obstacle, but that’s not true,” she says. “The biggest obstacle is we can’t get [the] study drug. We’ve had to wait 15 months for marijuana. Any expert grower in the country could have had marijuana grown to spec for us in three months. Only the federal government is so incompetent, it’s just pathetic.”

Sisley’s research will begin as soon as NIDA is able to provide her the drug, for which she needs a Schedule I license from the Drug Enforcement Administration, which she also can’t get before the drug is ready for delivery.

“The removal of each barrier against investigative research to determine the beneficial effects of this plant and plant extracts is good for public health,” says Lyle Craker, a University of Massachusetts Amherst plant scientist who struggled for years to open a second site for growing marijuana for research.

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Craker, with backing from MAPS, applied for DEA permission to open a second farm for pot research in 2001. He won the endorsement of a DEA administrative law judge in 2007, but the DEA’s then-leader, Michele Leonhart – a fiery marijuana critic – spiked the idea in 2009 and the U.S. Court of Appeals for the 1st Circuit ruled against him in 2013.

Leonhart resigned earlier this year following a sex party scandal and her interim successor, Chuck Rosenberg, is expected to make marijuana less of a priority.

Burge says MAPS is preparing a new request asking the DEA to allow a research grow site affiliated with the University of Massachusetts, and he’s hopeful Leonhart’s exit and the demise of Public Health Service reviews are signs the Obama administration is ready to open the doors wide to research.

“We’re hoping the overall political environment has shifted enough where we will actually get permission from the DEA to start this farm and then we won’t have to go through NIDA at all,” Burge says. “It’s a great opportunity for the Obama administration to show it’s progressive on marijuana issues. We’re pretty hopeful.”

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Mike Liszewski, director of government affairs at the pro-medical marijuana group Americans for Safe Access, called Monday “a landmark day for the advancement of cannabis therapeutics.” But he cautioned against irrational exuberance so long as medical pot use remains illegal federally.

“Any fruits of the research born of today’s announcement will not come for many years to come, yet we have millions of patients currently legally using marijuana under state law and their physician’s supervision to treat their medical conditions,” he says. “These patients, their physicians, caregivers and those who produce their medicine desperately need protection from federal interference.”