Roadblocks to Research

The has the only federally sanctioned marijuana farm for researchers to use. University of Mississippi

By Jayson Chesler and Alexa Ard,

Research on marijuana's potential for medicinal use has been hampered for years by federal restrictions, though nearly half the states and the District of Columbia have legalized the drug in some form.
An analysis by News21 shows that $1.1 billion of the $1.4 billion that the National Institutes of Health spent on marijuana research from 2008 to 2014 went to studies on marijuana abuse and addiction. Only $297 million was spent on its effects on the brain and potential medical benefits for those suffering from conditions like chronic pain.

"We don't have new things to treat for pain," said Todd Vanderah, the University of Arizona's chief of pharmacology. "We're still dealing with narcotics that have been around for thousands of years, and it's led to this issue of people abusing drugs and the rise of heroin."

Some parents with children suffering from seizures contend medical marijuana may treat their children more effectively than current medicine, but the Food and Drug Administration has not approved marijuana-based medicines for seizures.

"We're being denied that because they [federal agencies and doctors] don't know the long-term side effects of medical cannabis," said Heather Shuker of Butler County, Pa., whose daughter has a form of epilepsy.
Researchers like Vanderah have faced challenges getting federal approval and funds to study marijuana's medical uses. "The progress is a little limited, because research is done based off of grants that have been harder and harder to get," he said.

The federal government classifies marijuana as a Schedule 1 drug - like heroin and ecstasy - meaning it has potential for abuse and no medical benefits.
The approval process for any kind of research on marijuana is long and difficult - the FDA, Drug Enforcement Agency (DEA) and National Institute on Drug Abuse (NIDA) all play a role. Fewer than 1,000 NIH-supported projects studied marijuana for purposes other than abuse or addiction in the last seven years.

"It took me three years from the time I got funding to the time I could enroll my first subject," said Mark Wallace, a researcher studying pain treatments at the University of California, San Diego.

Spending disparity

News21 analyzed federally funded drug research projects from 2008 to 2014 using NIH's publicly available database, Project Reporter. The $1.1 billion that NIH spent to study marijuana abuse and addiction was $200 million more than what it spent studying crystal meth, a highly addictive stimulant whose abuse the DEA has called an epidemic.
While NIH spent $297 million on grants for non-abuse research of marijuana, it provide two to four times as much for similar research of opiates and benzodiazepines, including drugs like Xanax, according to the News21 analysis. Opiates are the narcotics that Vanderah said can cause drug dependency that leads to heroin abuse.

The research on marijuana abuse and addiction was largely funded by NIDA, a branch of NIH. The research covered subjects such as how parents can prevent substance abuse and studies of cannabis use disorder, which the American Psychiatric Association calls a problematic pattern of marijuana use.
Mahmoud ElSohly, the director of NIDA's marijuana program, said NIDA's job is to fund abuse and addiction research, not examine the drug's potential benefits. "It's not that NIDA would take it upon itself to investigate the medical aspects of cannabis," he said.

That would fall to other offices within NIH. But those offices have not funded much marijuana research. A National Institute of Neurological Disorders and Stroke (NINDS) spokesperson said that most NIH grants were based on what peer reviewers thought was the most promising science.
The National Institute of Mental Health (NIMH), for example, has spent just $48 million on marijuana medical research despite some states having approved the drug to treat PTSD.

Similarly, despite several states' approval of marijuana and cannabinoids to treat epileptic seizures, NINDS spent just $38 million through 2014 researching the potential effects of marijuana, compared with almost $100 million spent on opiate research, largely to treat different kinds of pain. Researchers said the number is expected to increase this year as more work is done on cannabidiol (CBD) - a major cannabinoid in marijuana that doesn't have psychoactive effects - and its impact on seizures.

Applying to research

Even when researchers are cleared to do federally funded marijuana research, they must obtain marijuana from a Mississippi farm run under the authority of NIDA.
The 12-acre farm, at the National Center for Natural Products Research, is nestled in the 640-acre University of Mississippi campus and surrounded by fencing, guards in towers, and lock vaults. It is the only federally sanctioned marijuana farm.

Before researchers can get marijuana and start their studies, they need an approved investigational new drug (IND) application from the FDA, a letter of approval from NIDA, and a Schedule 1 clearance from the DEA. The last is needed to posses and transport marijuana; researchers must also prove they have a secure facility to store it.
Outside of the university's contract with NIDA, ElSohly said he and other researchers at Ole Miss are conducting marijuana research of their own.

Even though federally approved marijuana is right outside their door, they still have to apply for it.
With a new $68.8 million contract, however, NIDA plans to help marijuana researchers by producing and growing products at the Mississippi farm that more closely mimic what dispensaries are selling to medical marijuana users. "The products were quite limited, as far as what we could get from them" before, Wallace said.
NIDA's marijuana farm is also growing 30 times more marijuana than it did under its last contract with NIDA, ElSohly said, a sign that researchers and NIH branches want more marijuana for studies.

Future of research

Congress could speed up the research process. Legislators have crafted bills to recategorize marijuana to Schedule 2 - which would designate it as federally accepted for medical use and ease the research approval process - and create more federal marijuana farms.
HHS removed the mandatory public health services review from the approval process to cut the steps needed for marijuana research.

Parents campaigning for a form of CBD to treat their children's seizures have already made strides in attracting attention. Vanderah said that research and treatments with CBD should pave the way for future research because it proves that marijuana-based medicine can really work.
"If you have your own child that's having 100 seizures per day and then they take some of this and it stops, you'll look at it very differently," he said.

He, and others predict future development in areas like multiple sclerosis, dementia, Lou Gehrig's disease, and neonatal hypoxic-ischemic encephalopathy (NHIE), a condition that cuts oxygen to infants. To treat such a variety, researchers are going to have to look at marijuana in many different ways, Wallace said. "It needs to be available in a wide range of products," he said.

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