The Drug Enforcement Administration seemingly squashed medical marijuana last week when it refused to reclassify the drug, mainly citing a lack of research supporting its benefits.
The news was salt in a wound to researchers in Colorado who have been striving to do such studies but feel thwarted by the entities that say no good research exists.
It’s a Catch-22, renowned marijuana researcher Sue Sisley said.
The Food and Drug Administration requires researchers to order medical marijuana from the federal government and test patients in a controlled environment. Until last week, that marijuana was nearly impossible to get.
Researchers were forced to do observational trials with patients who bought and used various marijuana strains on their own. Patients were in charge of their own medical care; the doctors merely watched.
And therein lies the problem, the DEA says. Support for medical marijuana has largely been based on stories, not studies.
The same can be seen in Colorado Springs. Residents who spoke to the City Council this year about the benefits of medicinal marijuana had only their personal experiences to back them up.
At the May 10 meeting, Bobby Patton told the council he suffers from depression, attention deficit disorder, nightmares and post-traumatic stress disorder, for which he was heavily medicated. “But now I don’t use any of those,” Patton told the council, saying marijuana helped treat his symptoms.
Parents Clint and Rebecca Lockwood say medical marijuana allowed them to keep their autistic son in their home.
“He’s so severe he eats our house; he eats our furniture,” the Lockwoods said, adding their son has been hospitalized after eating things he shouldn’t. Recently, though, they found a marijuana strain that helps alleviate his systems enough to get him back in school and in successful therapy.
“He was miserable before cannabis,” the Lockwoods told the council.
The Children’s Hospital Colorado website notes that, “Recent stories about children who have had positive outcomes from the marijuana derivative cannabidiol (CBD) give reason for hope and should encourage further studies.”
There’s not a complete lack of research in the state.
The Colorado Department of Public Health and Environment research division has put $9 million toward nine studies that could show marijuana’s health benefits in treating a number of ailments.
Children’s Hospital Colorado is involved in four of those studies, looking at the benefits of marijuana on adolescents and young adults with inflammatory bowel disease, pediatric brain tumors and two studies on pediatric epilepsy, according to the state website.
The University of Colorado School of Medicine at the Anschutz Medical Campus is looking at the drug’s tolerability and efficacy on tremor in Parkinson’s disease and its effectiveness as a painkiller over oxycodone.
The Department of Psychiatry at the University of Pennsylvania and the VA National Center for PTSD are conducting studies on treating PTSD with marijuana. National Jewish Health is looking at the use of marijuana as a sleep aid.
But the funding for that research came about “inadvertently,” grant program manager Ken Gershman said. The department accumulated surplus funding through fees on medical marijuana licenses, and state legislators decided in 2014 that the money could only be used for medical marijuana research.
Even that has been a slow process, said Sisley, whose group received the largest of the grants to study the efficacy of four potencies of smoked marijuana to manage chronic, treatment-resistant PTSD in veterans.
The process leading up to the study took seven years, Sisley said. And though the study was approved in 2015, they’re just now starting to accept patients and order their marijuana, she said.
Clinical trial leader for the study Rebecca Matthews said they’re hopeful the study will begin within the next month. They’ll be working with 76 veterans in Arizona and Maryland. Paula Riggs of the University of Colorado is one of the advising investigators in the study, Matthews said.
“Anyone who thinks it’s easy to do cannabis research, they just need to look at the saga that we’ve been through,” said Sisley, also an adjunct faculty member at Colorado State University-Pueblo.
Conversely, money generated from taxes on retail marijuana supplied the $2.4 million put into marijuana public health research grants aimed at exploring the “potential harm” of the drug, Gershman said.
Though the state health department has not selected the studies that will participate, applications indicated the department is particularly interested in the health effects of marijuana on fetuses and developing brains in adolescents.
“Although many people believe marijuana has medical benefit, there’s obviously a large body of evidence about some harmful things marijuana can do, and that’s also important to learn more about as well,” Gershman said.
The studies “are actually complementary,” Gershman said of two separate grants, “because together they try to look at a wider array of questions about marijuana.”
Even those studies may not be very helpful in persuading the FDA to make marijuana a viable treatment option, though.
Only three of the state’s nine medical marijuana studies are controlled clinical trials, and according to researcher Dr. Kevin Chapman, it’s only those double-blind, placebo-controlled studies that carry weight with the FDA.
Even his own study falls short of the mark, Chapman said.
The pediatric neurology and epilepsy specialist with Children’s Hospital Colorado is studying cannabis’ effect on epilepsy in children, but they’re not supplying the marijuana and they’re not controlling which strains are used or how much. They’re observing, retrospectively, the results parents see in the number of seizures their child suffers after starting cannabis.
“The DEA did look at what literature is out there, and if you hold the studies that are out there to a high standard, most of them – including our own – are of a pretty low level of evidence,” Chapman said.
Still, Chapman said there is value in studies like his because they’re “a bit more real-world.” They look at what Colorado families are actually doing to treat symptoms and the benefits they see, he said.
“It provides some information; it’s just not the highest level of information that we would like,” Chapman said.
His study is accepting new patients, he said. To sign up, visit CHC’s website at childrenscolorado.org.
A national study, though, may take medical marijuana to the next level, Chapman said.
GW Pharmaceuticals is believed to be close to producing the first U.S.-approved marijuana-based prescription drug. The U.K. biopharma is using cannabidiol, with the THC agent removed, to reduce the number of monthly seizures in patients with Lennox-Gastaut syndrome.
Patients in the clinical trial had 44 percent fewer seizures when given the drug in addition to the anti-epileptic drug regimens they were already on, according to early study results. Participants who received the placebo had a 22 percent reduction.
The firm plans to take the trial results to the FDA for approval in 2017.
“I sympathize with everyone’s concerns that the DEA didn’t deescalate the classification, but at the same time I would say there is data, at least for CBD, that is going to be coming out pretty soon,” Chapman said.
The biggest barrier left to cannabis efficacy research has been the DEA’s monopoly on who can provide the drug, researchers say. Until now, only the federal government’s marijuana farm at the University of Mississippi has been licensed to supply the drug for studies.
But the DEA said last week that it will open the field to other growers.
Even that has a caveat, Sisley warned, calling her reaction to the announcement a “muted celebration.”
The DEA blocked any growers already in operation from signing up for a schedule I license because, though it may be legal in their state, it remains federally illegal. That means a loss of institutional knowledge, Sisley said.
But it does open the door for other universities to apply and opportunities for new growers looking to get into the business, she said.
“It could mean a renaissance of cannabis research over the next 10 years,” Sisley said, cautioning with the words “could mean” because the announcement was not accompanied by a timeline for when new growers would be approved.
If the DEA is sincere in its promise to help make cannabis research more accessible, the U.S. should see movement within the next year, Sisley said.
“If they’re not sincere, we’ll know pretty quickly,” Sisley said.
News Moderator: Katelyn Baker
Full Article: Marijuana Researchers Cautiously Optimistic About Future Of Cannabis
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