News21: America’s Weed Rush

Responding to questions about research spending, Mahmoud ElSohly, the director of NIDA’s marijuana program, said that NIDA’s job is to fund abuse and addiction research and that other NIH branches should be funding other kinds of research.

“It’s not that NIDA would take it upon itself to investigate the medical aspects of cannabis,” ElSohly said. “It’s not the charge of NIDA. It’s the charge of other institutes within the NIH to investigate the use of cannabis.”

But the other parts of the NIH 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 medical marijuana research despite states approving it to treat PTSD. Yet the NIMH gave grants totaling $91 million for ketamine research —largely to treat depression —and almost $120 million for amphetamine research —largely to treat attention disorders.

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 to almost $100 million spent on opiate research, largely to treat different kinds of pain. Researchers said that 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 seizures.

Schedule 1

In 1970, Congress passed the Controlled Substances Act (CSA), which created one piece of federal law classifying all drugs. The law organized drugs into schedules based on their potential for abuse, status in international treaties and medical benefits.

Marijuana was temporarily designated as Schedule 1, but President Richard Nixon created a commission to do a review of the drug to determine if it should keep the most restrictive scheduling. The commission’s findings from research projects and public polls made up almost 4,000 pages of reports and technical papers published in four volumes in 1972. It concluded that marijuana should not be criminalized and suggested rescheduling the drug. But Nixon decided otherwise.

One hundred and sixty substances have been removed, added or transferred from one schedule to another since the CSA went into effect.

Investigators working with Schedule 1 drugs need an additional level of clearance from the DEA, also created during the Nixon administration to enforce the laws of the CSA, and to regulate the use of controlled substances. Wallace, the doctor at UCSD, cited five separate state and federal groups that sent him requests before he received approval for his research on how different doses of marijuana might be used to treat pain.

If marijuana were to be classified as a Schedule 2 drug, which would mean it has a federally accepted medical use, researchers would no longer need Schedule 1 clearance from the DEA to work with it.

“The Schedule 1 designation makes it challenging,” Wallace said. “I think if they move it to Schedule 2, it’s going to get a lot easier to research.”

That change is easier said than done, according to Matthew Barden, a DEA spokesman.

“A lot of people in the marijuana debate say to just put it under a different schedule, but in order to do that the FDA would have to change everything…” Barden said. “So we, the DEA, can’t just put something in Schedule 2. That would be a violation of how things are scheduled.”

Rescheduling can be done two different ways —by congressional action or administrative action. A few different bills have been proposed in Congress to give marijuana a different classification, but they’ve always died in committee.

The administrative route involves more steps and more agencies. To get the ball rolling, a petition must be filed by an interested outside party or the secretary of health and human services. The attorney general reviews the petition, and then forwards it back to the secretary of HHS to request scientific and medical evaluation by the FDA.

Findings and recommendations from HHS are reported to the attorney general, who then makes the decision whether to proceed with rulemaking after reviewing the evidence, which it will often do in consultation with the DEA. The DEA and FDA have the power to deny the petition if there is not sufficient scientific and medical evidence. If the attorney general can go forward with the rulemaking process, then the White House will decide if the rule could have economic effects or raises important policy issues.

Applying to research

Even when researchers are cleared to do federally funded marijuana research, they must obtain marijuana from a farm at the University of Mississippi, which operates with the authority of NIDA. The farm is located at the National Center for Natural Products Research, nestled in the eastern portion of the 640-acre Ole Miss campus, just steps away from the stadium where the Rebels play football.

The heavily secured farm is surrounded by fencing, guards in towers and lock vaults. The sprawling 12-acre, outdoor marijuana farm and growing room is the only federally sanctioned marijuana grow in the country.

“The National Institute on Drug Abuse is the only agency that is allowed under the federal law … to actually be in charge of the manufacturing and distribution of cannabis for any purpose,” ElSohly said.

HHS removed the mandatory public health services review from the marijuana research approval process to reduce the number of approval steps for marijuana research.

Parents campaigning for a form of CBD to treat their children’s seizures have already made strides in attracting public attention to marijuana research. 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,” Vanderah said. “They look at it as a medication, instead of how we always think of something like marijuana.”

Wallace, Vanderah and Schultz predicted future development in areas like multiple sclerosis, dementia, Lou Gehrig’s disease and neonatal hypoxic-ischemic encephalopathy (NHIE), a condition that cuts the flow of oxygen in infants. To treat such a wide variety of conditions, researchers are going to have to look at marijuana in many different ways —not just the extracts that companies like GW work with, Wallace said.

“I think what we’re going to find is a wide range of patient preferences, so we can’t think that we can just do away with the leaf and just extract it,” Wallace said. “It needs to be available in a wide range of products.”

This is from a continuing series from America’s Weed Rush, an investigation of marijuana legalization in America, a 2015 project of the Carnegie-Knight News21 program produced by the nation’s top journalism students and graduates.

This is from a continuing series from America’s Weed Rush, an investigation of marijuana legalization in America, a 2015 project of the Carnegie-Knight News21 program produced by the nation’s top journalism students and graduates.

This article appears in Oct 15-21, 2015.