November 6, 2019

Stanton A. Glantz, PhD

DEA is obstructing figuring out what is causing electronic cigarette/vaping lung injury (EVALI); someone high up needs to order them to stop

The biggest problem scientists who want to help figure out what is causing the epidemic of vaping-induced lung injury is that it is impossible for investigators to study the actual products that are being used.

This is because the Drug Enforcement Administration DEA prohibits investigators going out and buying legal (at the state level) cannabis products to study.  A university that violates this DEA policy could lose all federal funding under the Safe and Drug Free Schools Act.  The only cannabis that can be studied is from a farm in Mississippi that grows it under contract with NIDA.  This cannabis is not like cannabis grown today.  DEA has said they are going to authorize more grower contracts (they just got sued over this), but is moving very slowly.  More important in terms of the vaping lung disease epidemic, even if DEA allows more growers, this will not solve the problem of the need to study the THC devices that are causing the disease.

Fixing this does not require a change in the law.  All that has to happen is for the Administration to tell the DEA to allow legitimate investigators to go buy products for study and study them.

Of course, DEA might worry that local pot shops could declare themselves researchers and exploit this rule to sell more product.

This could be avoided by implementing the following policy:

The DEA should allow researchers to study cannabis or CBD in legally-available (at the state level) without a Schedule I research registration from the DEA as long as this work is done under an animal or human research subjects protocol approved by the local federally-recognized animal or human IRB.  (Chemical studies of the product itself would be considered “animal” studies.)

This exemption should also streamline the process for getting DEA registration to study cannabis(e.g., by creating a separate schedule for ‘research purposes’).  Creating such a research exemption from Schedule I because of the EVALI crisis would have the longer-term benefit ot allowing researchers to study the diversity of products which could lead to rescheduling to cannabis if ther are proven medical benefits.

Another problem in getting to the bottom of EVALI is that neither CDC nor FDA will make tissue samples available to university investigators to do studies that study things that CDC and FDA are not doing (genetics and proteomics, for example).  People are very frustrated that FDA has spent millions building the capacity at the Tobacco Centers for Regulatory Science (TCORS) like the one I direct, as well as to other grantees to develop important research capacity that may not be at the CDC or FDA. 

But neither the FDA nor the CDC are providing tissue samples from people stricken with vaping-caused ling disease to meaningfully contribute to solving the problem.

Another problem is that the overall framing that CDC and FDA are using is that this is an "outbreak" similar to a batch of tainted lettuce getting distributed and causing GI problems or an infectious disease outbreak where there is a "Patient 0."  This approach implicitly excludes the possibility that the problem is endemic to the product, which is what I and many others think is the case.

FDA and, to a lesser extent, CDC, are focusing on the THC devices and downplaying the nicotine devices.  While more people are using THC devices than nicotine devices, there is a lot of use of both because most people who developed EVALI were dual users.

My guess is that dual use is worse than either product alone because they tend to use different solvents.  (I would be surprised that THC or nicotine per se are causing the problems.)  I also doubt that the problems are the result of "tainted" product because the outbreak is so widespread.

Because, the largest group of victims are dual users (THC and nicotine), it is important to study the particular risks of dual use, i.e., the interaction between the solvents and other constituents in nicotine and THC devices that are different.  Another important question is what are the solvents that are used in the THC devices?  What do we know about how they interact with propylene glycol/vegetable glycerin, the most-used solvent in nicotine e-cigarettes?  What about the effects of flavors and how they interact with the solvents?

Answering these questions requires getting the actual products people are actually using.

The DEA has to allow this to keep the amount of unnecessary disease and death as low as possible. 

The question is: Who can order DEA to do this? 

In the meantime, the public, the press, and bipartisan members of Congress who are concerned about EVALI need to press for the answer.

And FDA and CDC need to start sharing samples with expert outside investigators.

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