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As the Food and Drug Administration moved to approve Pfizer’s Covid-19 vaccine earlier this week, some were quick to point out that cannabis is said to have no medicinal value by the organization when trying to sow seeds of doubt about the vaccine. 

But as longtime cannabis advocates who actually change laws, as opposed to focusing their attention on social media notoriety, attempting to compare the two doesn’t make sense. 

NORML Deputy Director Paul Armentano was quick to tell L.A. Weekly that attempting to compare the pace the Pfizer vaccine made it through the FDA process to cannabis is like comparing apples to oranges. 

“The existing FDA approval system is designed for the assessment of privately produced compounds that go through conventional P1, P2, and P3 trials – so the Pfizer vaccine comports with the existing regulatory model. Cannabis does not. It is an illicit botanic product,” Armentano said.

Armentano went on to explain the FDA approval process is not designed to evaluate such products.

“In fact, under the existing regulatory and legal environment, there is no process for which the FDA could review or approve herbal cannabis – as acknowledged by the DEA and others who are familiar with the process,” Armentano said. “The DEA acknowledged this publicly in 2016 and has done so repeatedly since.”

We asked Armentano if the recent move by the DEA to increase the pool of producers of research-grade marijuana could be the gateway to changes at the FDA. 

“It potentially could be,” Armentano replied. “When the system was set up in 1968 – and keep in mind that the system as it was envisioned more than 50 years ago, is essentially remained unchanged since that time – that system was established to promote limited federal research. That system was never established with the intent of potentially bringing any sort of whole-plant cannabis drug to market. And so not surprisingly, one could not engage in such an endeavor with this system in place as it currently is.”

Armentano went on to explain that anyone who wanted to bring the cannabis-derived product forward for trials would have to be a legally licensed producer of whole-plant cannabis, and then conduct the necessary phase one, phase two and ultimately phase three trials to establish safety and efficacy of the use of herbal cannabis to treat a specific medical condition. Then they’d have to bring that data to the FDA for review. 

“Currently, and since 1968, the only legal entity in America that could engage in that pursuit, if it wished to do so, is the University of Mississippi, and the University of Mississippi has no interest in trying to bring a potential whole-plant cannabis drug to market through the FDA review process,” Armentano explained.

But now, with the expansion of the DEA licensing system to include private entities that would therefore be legally permitted to grow marijuana for clinical research purposes, it is possible, or theoretical, that one of these licensed entities could be growing marijuana for the purpose of ultimately trying to create a dossier of clinical research data.

“Establishing the safety and efficacy of their whole-plant marijuana or their whole-plant marijuana product whether, say, it’s a tincture or an extract or a concentrate derived from the whole plants that they grow under that federal license,” Armentano said. 

Armentano believes they would have at least a theoretical route with which to engage in those processes. As for the future? It remains to be seen who these newly licensed entities are and whether it is the intent of any of those entities that are granted a license to ultimately try to bring an FDA-approved marijuana product to market.

We asked Armentano if it was reasonable to suspect the newly licensed farms could be licensed by larger entities to try and develop these products to run through FDA testing with the eventual goal of bringing the market.

“They are seen as very attractive to larger entities that might potentially have the capital, or the experience, bringing new drugs to market, although again, when we’re talking about a botanical product, that wouldn’t be a space that most of the major sort of conventional pharmaceutical entities would have a whole lot of experience in,” Armentano replied. “They have experience isolating single synthetic compounds, testing those compounds, and then bringing those compounds to market to try to treat a single endpoint.”

Armentano closed by emphasizing it’s important to understand the context of a lot of the cannabis research up to this point. He doesn’t want people to think that blind placebo tests involving cannabis research aren’t happening. It’s just they’re happening in the pursuit of expanding knowledge as opposed to making a buck, so there is only so much money for that kind of research to happen. 

“They’re just doing it for research purposes. Were one of those entities really trying to bring marijuana to market, they could theoretically do a phase three trial using that design,” Armentano said. “It would just have to include a lot more people and be longer in duration and then they’d have to actually take that data and go to the FDA, which of course they couldn’t do because they would have no proprietary rights over the marijuana they use because right now, to do the trial, they had to get the marijuana from the University of Mississippi.”

In the end, to get the FDA to move on marijuana’s medical value, someone will have to really want to make a buck off it. 

One person that’s had a long history of trying to prove medical value to the FDA is Multidisciplinary Association for Psychedelic Studies founder Rick Doblin. Doblin has worked long and hard over the years to clinicalize the debate around the value of cannabis and other substances like MDMA for medical value. 

We asked if it was tough to compare the clinical trials he’s gone through over the years with what happened with the Pfizer approval?

“Yes, yes it’s very different,” Doblin replied. “But the FDA does want to regulate botanical medicines. They are trying to find ways to make that happen. They’ve already said that we can look at the toxicity of the safety profile, without having to identify all the different ingredients in the plant and do separate studies with each one of them. Then we can do safety just on the outcomes to the people in general without having to piece apart that mechanical medicine. It’s been much simplified because the FDA does want to try to regulate chemical medicines and botanical medicines that aren’t necessarily as controversial as marijuana.”

Doblin said his most recent study in regards to PTSD and veterans proved safety but not efficacy. Many have argued a big reason for that was the quality of medical cannabis they have access to for the research. We asked Doblin to weigh in on the popular take. 

“Possibly yes, and for our new study, we are importing marijuana from somewhere. We’re not sure yet where – Australia, Canada or Israel, most likely,” Doblin replied. 

Doblin noted even with the recent openings of DEA-approved farms, he expects it to be a year and a half at the very least before the domestic supply of true research-grade cannabis is stable enough to use for research purposes. 

The National Cannabis Industry Association noted the FDA should not be forcing cannabis producers to undergo the expensive and lengthy Investigational New Drug process for products that are clearly outside that scope and available in dozens of states. 

“Since they seem to be unable to meet deadlines or consider this process reasonably, it may be up to Congress to mandate sensible CBD regulations,” Morgan Fox, NCIA Media Relations Director, told L.A. Weekly. “In the meantime, the lack of FDA regulations is discouraging bigger retailers from carrying CBD products, which is creating a glut that encourages producers to find other unregulated but more popular alternatives for the use of their stockpiles, specifically D8 and other relatively unknown and unresearched cannabinoid variants.”

Fox believes the best solution is to deschedule cannabis, and the longer we wait to do so, the more we are going to see unregulated cannabinoids flooding the market. 

“The least the government can do is move forward with reasonable science-based CBD regulation since it is clearly within their power to do so,” Fox said. “The FDA punting on this is only creating further nuances and headaches for Congress to deal with, not to mention advocates.”

 

LA Weekly