In late October, as the number of people sickened with a mysterious vaping-related illness grew, federal officials turned to the nation’s leading academic researchers for help.
“They wondered what, in our opinion, they should be taking a look at,” said Robert Tarran, director of the University of North Carolina Center for Tobacco Regulatory Science and Lung Health.
The roughly one dozen researchers in the Oct. 23 meeting told the National Institutes of Health, the Centers for Disease Control and Prevention and the Food and Drug Administration that they wanted to help with the outbreak — but that they are constricted by the government’s own rules.
Most cases had struck patients who vaped THC cartridges, often obtained through informal channels. But university experts typically cannot study these products without risking their federal research grants and their jobs.
Marijuana’s status as a Schedule I drug and the Drug Enforcement Administration’s rules limit academic research. A university lab is effectively banned from inspecting any product containing more than 0.3 percent THC. The potency of cartridges can climb to 80 percent or more concentrated THC.
The result: Amid the rash of deaths caused by vaping illicit THC, there are zero researchers in the United States allowed to do chemical analysis on THC products and recreate the effects of vaping them in the lab.
“That was duly noted by the people in the room, but they said they had no power to change this,” Tarran said.
Through conference calls, academic researchers have still been aiding the government’s investigation into the illness, known as e-cigarette or vaping associated lung injury, or EVALI. But the researchers’ work mostly concerns the health effects of tobacco products or solvents sometimes used in e-cigarettes, not vaping cartridges containing cannabis oils.
Last month, the House Judiciary Committee approved legislation that would deschedule marijuana, which would allow for studies without the DEA hurdles.
Tarran has researched the health risks of inhaling two oils, propylene glycol and vegetable glycerin, found in Juul’s e-cigarette cartridges.
But it’s another “cutting agent,” vitamin E acetate, that the CDC identified as a likely culprit and targeted for further investigation. Vitamin E acetate is commonly available and viscous, making it useful for black-market sellers who want to dilute THC oils in a way that buyers can’t visually detect.
“We can’t use federal money to study THC-related research. But the good news is that we can study the solvents that are commonly used to dissolve THC extract,” said Farrah Kheradmand, a Baylor College of Medicine pulmonary medicine expert who was among those the NIH met with in October.
The NIH confirmed in a statement that there was a closed-door meeting for an “internal working group” to “identify the most pertinent and urgent research questions related to e-cigarette or, or vaping, product use-associated lung injury.” The meeting was “tacked onto” an earlier meeting of the Tobacco Regulatory Science Program, the agency said.
After the meeting, the NIH announced funding opportunities for researchers to study EVALI, including work on liquids that can be used for vaping or the effects of exposure to e-cigarette aerosols.
“Supported research will have substantial public health impact and will inform the ongoing investigation into this illness as well as its diagnosis, treatment, and prevention,” NIH said.
But the limits on academic research directly on THC products restrict the ability of the nation’s vaping experts to get to the bottom of these unknowns and staunch the outbreak, some say.
“We are not allowed to touch any product. We can, and are, studying subjects who use them, but we cannot get product to study,” said Peter Shields, a lung cancer expert at The Ohio State University College of Medicine. “If we cannot study it, we will continue to be in total darkness about risk. The university position is that it is federally an illegal product, and so we cannot do research on this.”
“This subject comes up all the time,” he said.
The FDA is analyzing e-liquids for the presence of a range of chemicals, while the CDC is testing the aerosols vaped by people with EVALI.
“Analysis of aerosol emissions will augment FDA’s ongoing work to characterize e-liquid and will improve our understanding of exposure among case-patients associated with the lung injury outbreak,” a CDC spokesperson said in a statement.
But there are challenges, FDA acting Commissioner Ned Sharpless testified to Congress in September, including low levels of leftover juice and problems in determining which of the products a patient vaped caused the illness.
The New York Department of Health conducted its own testing on products that contributed to EVALI, and first identified vitamin E acetate as a potentially harmful substance when inhaled.
The CDC is also testing biological samples. Vitamin E acetate was discovered in the lungs of 29 sick patients from 10 states.
Academics and legalization advocates have long voiced concerns about restrictions on research — a trio of senators introduced a bill this Congress to ease them — but now those restrictions have collided with a public health emergency.
The protocol for any “learning institution” looking to study a Schedule I drug, including marijuana, involves approval from the Department of Health and Human Services and DEA registration.
The DEA requires that suppliers of cannabis products to universities register with the agency, too. For over 50 years, only one applicant has obtained that authorization: the University of Mississippi, whose marijuana farm supplies a product that researchers call substandard.
Investigators can analyze the lungs of people who smoked THC products, the most critical type of research for studying EVALI. But an academic investigator interested in studying THC products in a lab would have to find a manufacturer of vape cartridges willing to register their products with the DEA for study.
Legalization advocates say the likelihood of the DEA approving that application is low, given an apparent freeze on 33 outstanding applications.
“I’m sure most companies would jump at the chance to supply cannabis and cannabis products to researchers, and many are currently trying,” said Morgan Fox, a spokesman for the National Cannabis Industry Association. “Unfortunately, the DEA has delayed approving any new sources and it has been several years now since they committed to doing so, despite increasing their requested supply quota.”
But the DEA pushed back on the idea that the urgency of vaping-related deaths calls for a review of its application process, or descheduling marijuana.
“Researchers can’t just jump in and help FDA and CDC with their investigation. People must be qualified to handle these types of substances,” DEA spokeswoman Katherine Pfaff said.
“It’s the law. A Schedule I drug is an illegal substance. In order to conduct research, you must be approved to handle those substances because they are illegal,” she continued. “The whole point of [DEA’s] existence is to take those drugs off the streets and make sure they’re not in the wrong hands.”
Some lawmakers also voice concerns about allowing universities to study Schedule I drugs.
“We spent my whole life with smoking cessation of tobacco, and now we’re finally at a place where we’ve done that, and now we’re going to tell the whole country, ‘Let’s all start smoking marijuana instead,’” Pennsylvania Republican Rep. Scott Perry said in a floor debate this year about allowing for research into the potential of Schedule I drugs for medical treatment. “We need a lot more research before we tell our kids this is what they should be doing.”
The NIH did not comment on whether the scheduling of marijuana was impeding the investigation into EVALI, referring those questions to the DEA.
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