Research Hurdles: An Inside Look at the Burdens Imposed by Pot’s Schedule I Status

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The University of Washington’s medical research campus is a lengthy strip of buildings connected by a walkway that stretches nearly a quarter mile. It even appears to crown in the middle. As a postdoctoral scientist researching if cannabinoids are effective in treating epilepsy and autism, I’ve logged many miles in these halls. Every morning that I run experiments, I meet my dealer on the opposite end, 15 floors up.

My dealer is a research scientist from the Stella Lab, a global leader in cannabinoid pharmacology. She hands me a small transparent vial with the description, “cannabidiol” and the date. It’s a legal exchange. The cannabidiol was provided by the British biopharmaceutical company, GW Pharmaceuticals, but because it’s a Schedule I drug, the red tape doesn’t end with the handoff.

Before the turn of the 20th century, the federal government was silent on drug control policy. Yet, it was hard to ignore that morphine use remained high among Civil War veterans decades after Appomattox. Opium use was also spreading westward alongside railroad expansion. The flourishing opioid popularity and rising addiction rates forced the government’s hand. By 1970, there were over 200 federal drug laws covering the spectrum of abused drugs. Numerous inconsistencies across the laws made enforcement especially challenging.

In response, Richard Nixon signed the Controlled Substance Act (CSA) into law, essentially combining all prior federal drug laws to regulate the manufacture, distribution and possession (including research) of drugs through a classification schedule from 1 (the most harmful with no medicinal benefit) to 5. Developers of the CSA fretted over where marijuana fit into the schedule so it was listed as a Schedule I drug, pending review. Two years later, the National Commission on Marihuana and Drug Abuse, now known as the Shafer Commission, issued its report suggesting that there was no serious health threat to using marijuana and the government should consider decriminalizing its possession. But political motives steeped in racism and fear of “amotivational syndrome” blocked any change to marijuana’s Schedule I classification. The “Just Say No” Reagan era and its wake solidified marijuana’s status.

Even derivatives of marijuana, including a medicinal favorite, cannabidiol, fall into the CSA’s Schedule I classification. By this definition, their high potential for abuse in combination with no accepted medicinal benefit puts them in the same category as heroin and LSD. The recent DEA decision to retain Schedule I classification status for marijuana does not prevent researchers from studying its potential medicinal benefits. In fact, in 2015, $21.2 million dollars in federal grant money was awarded to projects investigating the therapeutic potential of cannabinoids, and $9 million in grant money going to research on cannabidiol alone. These studies, and those that preceded them, have contributed to two FDA-approved medications containing marijuana derivatives and a host of human clinical trials for treating disorders from schizophrenia to epilepsy. But despite the apparent recognition of clinical cannabis’ therapeutic utility, marijuana remains a Schedule I drug.

The DEA calls my dealer an “officer” (although I prefer to announce to my lab that I’m off to see my dealer). Along with the lab’s Principal Investigator (i.e., the boss), she’s the only one allowed to directly handle the drug. Before dilution, cannabidiol must be held in a locked box, behind a locked door. Only the officers have access to these keys, and they must remain with them throughout the day. Removal of cannabidiol from the box is meticulously recorded on carbon copy paper and signed by a witness (yes, they still use carbon copy paper!). These pages must be surrendered during random DEA audits. The Stella Lab has successfully weathered all three random audits during their 15 years of holding a Schedule I license (up until a couple months ago, they held the only license to obtain Schedule I drugs at the University of Washington), but more labs who are looking to “get in the game” are lining up and waiting the two-year approval period for this privilege.

And a privilege it is. Cannabis research is a hot area now that recreational marijuana is legal in four states, medicinal marijuana is legal in 25, and medicinal cannabidiol in 15 others. Here in the state of Washington, marijuana is legal and can be purchased in one of 250 dispensaries (500 licenses have been issued, so the number is growing). Yet, because research at the University of Washington is supported by federal dollars, if I want to give rodents cannabidiol, I have to jump through regulatory hoops that would be laughable if they weren’t so time consuming.

The effort required to legally study cannabis is discouraging, but this important research needs to be conducted. Increasing anecdotal evidence points to the therapeutic efficacy of marijuana and its derivatives (e.g., cannabidiol) in disorders, including our lab’s focus in epilepsy, anxiety and autism-like social deficits. However, the basic science to support these findings is in its nascent stages. These controlled, double-blinded studies in rodents and humans are critical for determining the patient populations who will see the greatest benefit of using medicinal cannabis, as well as proper dosing levels and frequency. My patient is a mouse with a genetic mutation that causes it to have epileptic seizures and autistic-like social impairment.

Before beginning experiments, I enlist a graduate student to volunteer their time to witness my injections. Together, we trudge down to the mouse house, a series of rooms in the basement of the medical research building. It’s isolated, quite and free of distractions, for the mice, and myself. The mice receive cannabidiol via injection into their abdominal cavity. It’s the only reliable way of making sure they all get the same dose at the same latency for testing. I inject one hour before testing to hit the peak brain cannabidiol concentration. (This quick cannabidiol action results from the intraperitoneal injection. In humans, oral cannabidiol consumption leads to a peak brain concentration at approximately 3-4 hours.)

With each injection, I log the exact amount of cannabidiol administered, to the microliter, calculate the remaining volume and get signed off by the witnessing graduate student. Remaining cannabidiol will be stored in a safe that can only be accessed by following a trail requiring three separate keys. Any spill, or missed injection, is suspicious and must be reported. If the log doesn’t precisely match the remaining drug volume, an untimely DEA audit could bring an end to my research.

Fear of failing to pass a DEA audit is justified.

The DEA employs hundreds of Diversion Investigators who have the right to show up at any time, without warning. Even negligent misconduct, as opposed to willful misconduct, can carry a $10k fine and block further research. A couple calculation errors, and we’re toast. With handwritten logs and on-the-spot calculations over hundreds of iterations, mistakes can be made. The Diversion Investigator enters the audit with the mindset that a fat-fingered calculator error is indistinguishable from willful skimming of small amounts of drug. The repercussions would be disastrous if we were found to be non-compliant. Currently held grants could be forfeited and future grants no longer acquired, accounting for thousands to millions of dollars in lost research revenue. Not only would I no longer be able to acquire cannabidol from the lab holding the Schedule I license, but my error could cause them to lose their license.

Losing the ability to acquire a critical research tool, cannabidiol in this case, would require me to scrap the project and forgo years of research. This could be catastrophic to the lab’s success. Funding agencies, including the National Institute of Health, view long periods of “inactivity” (i.e., no publications or conference presentations) as major penalties against a candidate, making it increasingly more difficult to receive funding. Thus goes the downward spiral.

So I dot my I’s, cross my T’s, and calculate twice.

American Mary is a recreational marijuana dispensary a mile from the medical research building. You can walk there in 20 minutes. With only my ID and a bit of cash, I can purchase grams upon grams of concentrated cannabis derivatives across the spectrum of CBD:THC ratios. I can consume it all, no questions asked. But a mile down the hill, I need collaborative justification and access to a lab with a rare Schedule I drug license. This is clearly the most difficult part. But I also need special limited access rooms and drug safes. I need busy lab members to volunteer their time to be witnesses. I need error-free accounting. And maybe I just need a research environment that’s as open to medicinal marijuana experimentation as the one that exists beyond the university’s boundaries.

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