US Cannabis Research Is Still Hindered, So What Regulatory Changes Do Scientists Want to See?
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There has arguably never been a more important time for cannabis research. As more states elect to legalize the medical and recreational consumption of cannabis within their jurisdictions, an increasing number of Americans will begin using products that remain federally unregulated and unapproved.
While this cannabis is tested for contaminants and other safety issues at the state level, current federal regulations still tie the hands of many researchers who wish to further study the general safety of these products and the wider cannabinoids on the human body.
In a recent paper published in the New England Journal of Medicine, scientists from the Emory University School of Medicine and School of Nursing outline the current state of cannabis research-related legislation in 2020, and recommend future next steps that could improve research capabilities.
The appetite for legal reforms
As the scientists explain, researchers who plan to conduct clinical trials using cannabis must currently go through a lengthy process of seeking separate approvals for their project from both the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA).
This can take a year or more to complete. And even when approval is secured, researchers can only access cannabis grown from one single government-authorized farm at the University of Mississippi, a source that has been previously criticized for its poor product quality and its inability to reflect the types of product currently available on the market.
“Right now, we are really quite stuck by the lack of regulation surrounding cannabis,” Dr Joshua Levy, an assistant professor of otolaryngology and director of resident research at Emory University’s Department of Otolaryngology, tells Analytical Cannabis.
“It is differentially regulated on both state, local, and federal levels. Because of that, physicians and other researchers who seek to appropriately study this potential medicine are really hamstrung. Even if we do follow the rules that are prescribed by the government and we use the only federally-regulated source for the plant, we’re actually still not studying the exact material that is being sold by state dispensaries and that is being attributed to reported health benefits.”
In the wake of the e-cigarette or vaping associated lung injury (EVALI) crisis, there has been a clear need to allow researchers to investigate the cannabis products that are currently available on the market. Perhaps doubly so now with the ongoing coronavirus pandemic, these kinds of health crises highlight the poor access that physicians have to reliable evidence and data illustrating the effects of cannabis products on the respiratory system and on the rest of the body.
“A fantastic question that I have not seen evidence one way or the other for is whether this vaping may have predisposed [some people] to Covid-19, or altered the effects of infection. And we just don’t know,” says Levy.
“My hope is that the response to the coronavirus pandemic will further increase the appetite and the recognition that cannabis needs to be studied. But other than a rising chorus of voices, so far nothing has been done.”
Bettering access for researchers
The Emory scientists recommend two specific policy changes, which if implemented could improve the access that researchers have to cannabis suitable for high-quality research, they say.
First, in states where medical or recreational cannabis is legal, the federal government could start accepting applications from academic institutions for Schedule 1 licenses for cannabis research, thus lifting the burdensome application process for individual researchers at these institutions. Allowing multiple researchers to work under a single institutional license could significantly increase the quality and quantity of cannabis-related research, the authors say.
Secondly, institutions with such a license could be permitted to contract with state-sanctioned and licensed dispensaries to investigate the products that are currently being sold on the market to patients and recreational users.
“The ultimate goal of the viewpoint was just to increase access so that we can do the proper studies – both to find the positive attributes of marijuana use or cannabinoid use, as well as the potential harms,” Levy explains. “These [current] limitations that really confuse the issue and muddy the waters.”
“The call that we have for private industry [such as licensed dispensaries] to take a lead really was one out of feasibility. I have no preference or even appropriate insight to advocate for a government-run program versus private-public partnerships. Any organization that can provide quality and really ensures that we’re studying the compounds that we think we are is fantastic.”
The new FDA research guidance – a step in the right direction?
In late-July, the FDA issued draft guidance aimed at encouraging cannabis-related clinical research. While the guidance is limited predominantly to cannabis-related pharmaceutical drug development, it does allow for these drug development researchers to use any hemp products legal under the 2018 Farm Bill (i.e. containing less than 0.3 percent THC) for studies, freeing research beyond the hemp material produced by the federal source at the University of Mississippi. This bears a striking resemblance to the second of the two policy changes that the Emory scientists recommend for the wider field of cannabis research.
“I think it’s certainly a step in the right direction,” says Levy, when asked about this new guidance.
“If for political reasons – which is my read on it – that has to be limited to hemp products as opposed to a higher THC-containing product, that’s okay with me. That’s at least the first step and hopefully one regulation will lead to the next.”
Looking to the future, Levy is optimistic that a more accessible framework for cannabis research can be built and implemented to serve the nation’s academics and researchers.
“I have a lot of hope. The need is so clear,” he says. “I am not aware of any compound in the history of drug development that is so widely used for medicinal purposes, yet still regulated [in this way]. I think the need and the market will, in its own right, push for reform.”
“But as you add EVALI and Covid-19 and these other acute issues that need more research and understanding into the mix, they will certainly add to our need to understand risk and treatment options. I think it’s just a perfect storm to push things forward, and hopefully, that will happen sooner rather than later.”
Analytical Cannabis also reached out to Dr Raphael Mechoulam – the pioneering cannabis researcher credited with the first synthesis of THC – for comment on the FDA’s new research guidelines. Although based in Israel, Dr Mechoulam has helped lay the research foundations for a new class of synthetically stable cannabinoid compounds, which are due to enter the first phase of FDA approval testing in the US.
“The guidelines require some knowledge of FDA procedures, which I do not have,” Mechoulam tells Analytical Cannabis.
“[But] I received an analysis of the new FDA guidelines from a publication (Harris Bricken’s Canna Law Blog). I found that most of their analysis parallels mine.”
The concluding insight from Mechoulam’s cited report reads as follows:
“It remains to be seen whether these standards would prove burdensome for hemp drug developers, but these [dry weight] calculation methods are particularly interesting in that they are the first practical cannabis-related guidance published by the FDA.”
“Though drugs are regulated differently from other categories of products that fall under the authority of the FDA, these methods of calculation provide hemp CBD stakeholders with a potential framework for calculating the delta-9 THC and CBD dosage of finished products.”
“All that said, this guidance is not binding, it is merely a reflection of the FDA’s current thinking on the manufacturing and testing of hemp-derived drugs. As such, it remains to be seen if the FDA’s current recommendations will become legal requirements following the 60-day public comment period.”