Challenges slow cannabis research despite rapidly expanding industry

Start with the wrong seeds or harvest at the wrong time and Cornell Hemp and the farmers it supports would be in trouble with the federal government for growing illegal marijuana.

That’s because the difference between hemp and marijuana is not botanical, but regulatory. Federal law defines hemp as cannabis with less than 0.3% THC, while plants with more than 0.3% THC are considered marijuana and must be destroyed.

And a new federal rule redefined THC to also include its chemical precursor, making the 0.3% restriction harsher to the point that 61% of Cornell Hemp’s CBD variety plants became noncompliant. This and other regulations governing hemp producers nationwide will hang in the balance until the U.S. Department of Agriculture reviews nearly 5,000 public comments on the rule and publishes an updated version by November 2021.

Toth said that the previous THC limit, let alone the new rule, was already causing problems for their goal to create a hemp variety high in CBD, the product for which 77% of hemp was planted nationwide in 2019.

He said the problem with the restriction is that CBD and THC occur together in consistent ratios that breeders have not yet succeeded in separating. For hemp varieties high in CBD production, the ratio is about 20-to-1, making plants with more than 6% CBD noncompliant with the original THC rule. That cap forbids researchers’ access to already existing plants bred to produce as high as 20% CBD.

George Stack, another Cornell doctoral student who researches hemp’s resistance to pathogens and insects, said the 0.3% THC limit restricts breeders’ ability to innovate.

“In plant breeding you are trying to take the best genes from the widest diversity you can find,” Stack said. “If you are restricting what diversity you can work with based on these regulations, that’s going to drastically hamper research and breeding, so that’s going to hamper the entire industry.”

Stack and Toth hope that New York will grant separate hemp licenses for researchers that will be more flexible than the national guidelines, such as a license that would allow researchers to grow plants noncompliant with federal law as long as their goal is to produce compliant plants.

This flexibility for research will likely have to come from state governments, since only Congress has the authority to change the 0.3% limit.

If the regulatory hoops involved in hemp research are any indicator, the difficult legalities of marijuana research are another side of the same coin.

Marijuana is classified as a Schedule I substance in the federal Controlled Substances Act, which is its strictest category and defined as “drugs with no currently accepted medical use and a high potential for abuse.” Other drugs in the category include heroin and LSD.

For researchers, Schedule I translates to difficult access to the substance. It also forbids doctors from prescribing marijuana without a rare Schedule I license from the federal Drug Enforcement Administration. Medical marijuana programs allow physicians to authorize patients with a medical marijuana card, but information from these patients can’t be used to conduct clinical trials, which involve a doctor giving patients a drug in a controlled study.

The medical societies of New York, New Jersey, and Connecticut recently issued a joint statement to promote moving cannabis to Schedule II in order to allow easier access to marijuana research licenses and data through clinical trials.

“There’s a lot of evidence that could be gathered and it’s just not being done,” said Arthur Fougner, president of the Medical Society of the State of New York.

As an OB-GYN, he is especially afraid of the potential developmental risks cannabis could have if used by pregnant women. He’s also worried about lung illnesses related to cannabis vaporizer products. But he said the medical evidence isn’t there to substantiate his concerns one way or the other and that the world of marijuana is overrun with anecdotal “I-tried-it-and-it-worked” type information.

“We desperately need research,” he said. “Most of the stuff that’s being done is on the same level as late-night TV infomercials.”

Fougner said states legalizing recreational marijuana is putting the cart before the horse considering the lack of evidence about marijuana’s health benefits and risks.

“This needs to be done at the federal level, to take this drug out of schedule I to allow research labs access,” he said.

Five out of six marijuana bills under congressional review this year seek to do exactly that.

Two bills, the Marijuana Opportunity Reinvestment and Expungement (MORE) Act and the Marijuana Freedom and Opportunity Act, seek to completely remove cannabis from the Controlled Substances Act.

Another bill, the Medical Cannabis Research Act of 2019, would establish a new registration process for growers of cannabis for research purposes. For cannabis researchers interested in studying plant material itself, as opposed to derived products like extracts, the University of Mississippi remains the only U.S. grower permitted by the federal Drug Enforcement Administration. The Cannabis Research Act would replace the DEA’s current process that has had more than 30 pending marijuana grower applications since it opened in 2016.

Yet another bill seeks to amend the CSA to increase marijuana’s accessibility to researchers, and the fifth bill would move marijuana to Schedule II.

As DEA approved researchers with a Schedule I license, Columbia University professors Diana Martinez and Margaret Haney are currently conducting a clinical trial with cannabis extracts. Martinez, a professor of psychiatry at Columbia University Irving Medical Center, said that proven medical uses of cannabis show it doesn’t fit the criteria of a Schedule I drug.

“There’s little question that it should be rescheduled,” she said.

Though it is unclear if and when cannabis might be rescheduled, the DEA has increased the number of registered marijuana researchers by 155% in the past five years, the DEA said in a statement. But getting DEA approval to study marijuana is only half the battle, Martinez said.

The other half is confronting the lack of cannabis companies willing to provide the safety information federally required for clinical trials, she said.

In their trial, Martinez and Haney are studying the effectiveness of chemicals from cannabis to treat chemotherapy-related symptoms in cancer patients. To do so, they are giving patients different strengths of THC and CBD in pills.

But when Martinez and Haney embarked on the study last year, they had difficulty finding a cannabis producer willing to meet the Food and Drug Administration’s standards. The FDA requires drug producers involved in any clinical trial, whether for cannabis or not, to provide safety data such as proof the drug is free of pathogens, mold, bacteria, and heavy metals, and that it has been safely given to humans.

Martinez and Haney contacted several medical cannabis companies and dispensaries that were all unwilling to go through the necessary process with the FDA.

“Companies are selling cannabis products and they’re making huge profits and so they don’t want to bother showing me or showing the FDA that their product is safe,” Martinez said.

She said that for marijuana research to improve, it is essential not only that the DEA improve accessibility to licenses, but also that cannabis companies be held accountable to comply with federal research regulations.

“I understand it’s a pain but it’s important and it has to be done,” Martinez said.

Back on the hemp side of the cannabis research equation, Cornell Hemp’s researchers are busy developing a profitable hemp crop for New York with a major caveat: avoid THC at all costs. Stepping over that 0.3% line opens an entirely separate rule book.

After hemp was bundled with marijuana when cannabis was illegalized in 1971, the U.S. destroyed its entire collection of agricultural data on the crop and eradicated 4.7 billion hemp plants nationwide. Five years ago, Cornell Hemp had to start again from square one.

Despite hemp’s centuries of cultivation in the U.S., recent history makes a difficult task of unknotting hemp’s ties to its high-THC counterpart.

In the lab, Toth opens a freezer taller than himself, packed with boxes of plant material taken from the greenhouses — plenty to run more genetic tests with, like the one Toth developed to tell the difference between marijuana-type and hemp-type plants.

It’s one piece in the puzzle of Cornell’s breeding program that means the difference between lawful and criminal for Cornell Hemp researchers and the New York farmers they serve.