Georgia CTSA KL2 Scholar Co-Authors NEJM Perspective Piece

"The Georgia CTSA is an incredible group of colleagues to build together. My experience in the Georgia CTSA KL2 Program is just one example of how an investigator is being supported by this talented team of people and comprehensive resources to make exciting advances and produce outstanding work," says Dr. Joshua Levy.

Joshua M Levy, MD, MPH, Emory Sinus, Nasal & Allergy Center; Assistant Professor, Department of Otolaryngology-Head & Neck Surgery, Emory University School of Medicine; and Georgia Clinical & Translational Science Alliance (Georgia CTSA) KL2 Scholar co-authored a paper about how researchers have limited access to cannabis products for clinical trials to confirm benefits or harms of these products that patients are using to treat themselves. This Perspective was published on May 14, 2020, in The New England Journal of Medicine (NEJM) in "The State of Cannabis Research Legislation in 2020".

“The credit for helping me explore a relevant ethical issue that is currently impacting clinical research belongs to Dr. Blumberg, Principal Investigator, Georgia CTSA KL2 and TL1 programs, and the Georgia CTSA MSCR program. The research that I do to improve outcomes for patients with combined allergy, sinus, and airway conditions is only tangentially related to cannabinoids. In the joint MSCR-CPTR ethics class, which is part of the NIH curriculum for funding recipients, we discussed in a group format different ethical issues that we can see developing and what our thoughts are. I came up with this very simple question: If my research is successful that would then support clinical trials using commercially available cannabis products is that even possible today? The answer is mostly no. Nothing is impossible, but it's incredibly prohibitive and very difficult given all of the understandable legal issues surrounding products that come from marijuana,” says Levy. “So, my friend and classmate Dr. Jennifer Friediani, who is enrolled in the Georgia CTSA CPTR program, and I, along with our colleague Dr. Ali John Zarrabi, submitted this issue and our recommendations to The New England Journal of Medicine (NEJM). We are pleased NEJM published our submission as a Perspective piece especially since it's very timely. It speaks to legislation that's currently in front of Congress. With this paper being released so quickly, it can speak to the public commentary period before the House.”

“I am a proponent for science; the more research that can be done, the better. There are major public health implications of our lack of research into these cannabis products. A growing number of patients ask their physicians and healthcare providers their thoughts on these chemicals and compounds that these patients are using freely under the guise of healthcare and for health benefits. Unfortunately, since researchers are unable to access commercially available cannabis products for clinical trials, we don't have the evidence to support if it's beneficial or harmful. Also, we're seeing vast respiratory disease outbreaks, and there's a concern with COVID-19 that people who use marijuana are at higher risk for complications. The more we can specifically study what these patients are using, the more informed our treatments can be.”

“There's friction between federal government regulating access and controlling what can be studied clinically and states doing the exact opposite by legalizing medicinal marijuana and allowing recreational cannabis sales. That has to be resolved. The federal government is being asked to allow institutions to study the products that patients are using to treat themselves. The fact that this issue is now before Congress is a positive step. There needs to be improved access with appropriate oversight. This lack of access is preventing the appropriate study of compounds that patients are freely using on their own that impacts their health.”

As a KL2 Scholar, Dr. Levy has been encouraged to explore ethical, legal, and social issues of responsible clinical research. Dr. Levy adds, “I feel so lucky and grateful for the opportunity to be a Georgia CTSA KL2 Scholar. The KL2 program has allowed me to take my interest and passion and provide me the skills and resources to make it my career. Research is what I think about in the morning. It has been rewarding to connect with a community of people who have the same feeling. Being a KL2 Scholar allows me to work with people like Jennifer, who from a clinical and research standpoint does very different things than I do, and shows us how to find common ground. Through this program, we’ve already written a paper that's now being published at a high level and expands our net of who we work with and what we can accomplish.”

The KL2 program provides the opportunity for didactic training, in large part through the Emory Master of Science in Clinical Research (MSCR) or the Certificate Program in Translational Research (CPTR) programs, and also requires that the trainee have an established and successful lead mentor, as well as an Advisory Committee, who could provide further guidance and training for those pursuing careers in clinical and/or translational investigation.

“This program has allowed me to work side-by-side and develop a true friendship with my outstanding mentor, Dr. David Guidot. Otherwise, it would just be a strictly professional clinical relationship. I get more satisfaction out of that than any other part of my career,” comments Levy.

Dr. Levy’s mentor concurs. “The opportunity to work with Josh as a mentor on his clinical research was serendipitous and has been one of the great pleasures of my academic career. Josh is smart, talented, creative, incredibly motivated, and remarkably self-directed. My main role as his mentor is to not get in his way and just enjoy the ride,” remarks David M. Guidot, MD, Jeffrey R. Pine Chaired Professor of Medicine and Director, Division of Pulmonary, Allergy, Critical Care & Sleep Medicine, Emory University School of Medicine.

The goal of the Georgia CTSA KL2-Mentored Clinical and Translational Research Scholars Program is to support and enhance career development for junior faculty (MD, PhD, MD/PhD, or PharmD) from a wide variety of disciplines at Emory University, Morehouse School of Medicine (MSM), Georgia Institute of Technology (Georgia Tech), and University of Georgia (UGA) College of Pharmacy. The Georgia CTSA KL2 Core is committed to assisting junior faculty at partner institutions to become independent, established, and ethical clinical and/or translational research investigators.

The Georgia CTSA is a statewide partnership between Emory, MSM, Georgia Tech, and UGA and is one of over 60 in a national consortium striving to improve the way biomedical research is conducted across the country. The consortium, funded through the National Center for Advancing Translational Sciences (NCATS) and the National Institutes of Health's Clinical and Translational Science Awards, shares a common vision to translate laboratory discoveries into treatments for patients, engage communities in clinical research efforts, and train the next generation of clinical investigators. For more information, click here.