Penn State College of Medicine received a five-year, $20 million federal grant to investigate the harmful effects of alternative tobacco products, research that will help with better regulation and improve public health.
March 13, 2024
The College is one of just seven sites across the country to receive the grant as part of the Food and Drug Administration (FDA) and National Institutes of Health’s (NIH) Tobacco Centers of Regulatory Science (TCORS) funding that was awarded in the fall.
The TCORS award will fund a trio of studies, led by the College’s Center for Research on Tobacco and Health, that explore how the design of alternative tobacco products can affect their toxicity and addictiveness.
“Our center is unique in that we are addressing both the chemical toxicity of tobacco products (the part that causes harms directly to the human body), and the addictiveness of tobacco products (the characteristic that results in people using tobacco products for decades rather than a few months or years),” said Jonathan Foulds, PhD, one of the principle investigators (PI) and professor of public health sciences, psychiatry and behavioral health. “It is the combination of these two factors that determines the overall health effects.”
The single largest contributor toward preventable premature death in the U.S. is cigarette smoking-caused disease, he added, so this research could have a significant ripple effect for public health and policy.
“The benefits to the public are two-fold,” he said. “One is that the scientific results of our studies will be able to clarify the relative harmfulness and benefits of these new products so the public can make better choices. Two, through our research, we can also inform the FDA of the harmfulness and benefits of these products so they can better regulate them in the interest of public health.”
The funding also supports three distinct units as part of the Center for Research on Tobacco and Health, called “cores,” that bring multidisciplinary teams to the table. The Biostatistics and Data Management Core lends a team of statisticians to help researchers properly analyze research data, while the Biomarker and Analytical Chemistry Core guides the biochemical analyses of each of the three research projects.
The Career Enhancement Core (CEC), co-led by Andrea Hobkirk, PhD, assistant professor of psychiatry and behavioral health, public health sciences and neural and behavioral sciences, and Jessica Yingst, DrPH, assistant professor of public health sciences, is a unique component of the TCORS funding: It expands the reach of TCORS to directly involve learners and trainees from different career stages in the tobacco research. The CEC includes undergraduate and medical student summer interns, predoctoral scholars enrolled in doctoral programs at the College, postdoctoral fellows and faculty investigators new to tobacco regulatory science.
The College’s Summer Undergraduate Research Internship Program provides a pipeline for the TCORS CEC and its applicants come from all over the country, Hobkirk said, while the medical students are selected from the College’s medical school programs.
All TCORS research centers are required to have a CEC and each site develops training opportunities that are unique to their own research and expertise – opportunities that are available to trainees at TCORS sites across the country. The chance for learners and trainees to get involved, Yingst said, helps to mold the next generation of tobacco regulatory science researchers.
“Trainees involved with the TCORS and the CEC will be connected with a diverse network of researchers and policy makers across the United States, providing access to unique opportunities and experiences that trainees typically do not receive working in only one laboratory,” she said.
Anyone who is interested in joining in the training didactics or research with the Penn State TCORS team should email [email protected].
Significant impacts on public health
The Center for Research on Tobacco and Health was established through an earlier round of funding in 2013, when the College of Medicine was first designated as a TCORS site. The first round of funding continued through 2018 but notably, Foulds said, the center was able to continue its research into tobacco regulatory science by generating additional grant funding from the NIH and other institutions.
“We’ve been so successful in getting a lot of research funding partly because of the expertise of the faculty, researchers and staff here,” Foulds said. “We have expertise that spans across the disciplines necessary to investigate both chemical toxicity and addiction. For example, parts of our center are led by Joshua Muscat, PhD, an epidemiologist and professor of public health sciences who is co-PI on the TCORS grant, as well as chemists and faculty trained in the psychology of addiction.”
Partly as a result of the first round of TCORS funding and research, both the U.S. and New Zealand governments have proposed a strategy to reduce the allowable amount of nicotine in cigarettes to minimally addictive levels – providing an example, Foulds said, of how this type of research could directly affect government policy and public health.
The Penn State TCORS team will research three alternative tobacco products during this round of funding: e-cigarettes, little cigars and oral nicotine pouches.
While these products aren’t smoking cessation medications (like Chantix), understanding how harmful they are can help researchers discern if there are benefits from cigarette smokers switching to some of these products.
“There are a lot of people who don’t want to take a medication and who like the nicotine effects but don’t like the withdrawal,” Foulds said. “For them, switching to a less harmful nicotine product may reduce their health risks.”
The researchers hope that if some of these less harmful, alternative tobacco products are available in a regulated manner – a big problem right now, with so many unauthorized products on the market – then that, coupled with laws making high-nicotine cigarettes illegal, could spell the beginning of the end of cigarettes altogether.
The public health ramifications would be significant: It would mean an astronomical reduction or near-elimination of smoking-caused diseases like lung cancer and chronic obstructive pulmonary disease.
“In 1997, 25 percent of high school seniors were daily cigarette smokers. Now, less than 2 percent of high school kids smoke cigarettes,” Foulds said. “That 18 to 25 age group is now using e-cigarettes and nicotine pouches rather than cigarettes, and we need to assess the potential health effects. Largely as a result of less smoking, we’re already seeing a fairly rapid decline – 44 percent – in lung cancer rates in men aged 50 to 54 over the past 20 years.”
What the TCORS team will be studying
Project 1: E-cigarettes
Project 1 will explore the question of whether inhaled e-cigarette oxidants and their potential for harm are influenced by product design features. Generally speaking, an oxidant is a chemical that is highly reactive with other chemicals, which can create new chemicals and thus increase the risk for cancer and other diseases. It will also test whether the biological effects of these oxidants can be measured through biomarkers (like urine samples) of both exposure and harm.
The project was originally led by John Richie Jr., PhD, who died in 2023. Project 1 is now co-led by Zachary Bitzer, PhD, assistant professor of public health sciences, and Thomas Spratt, PhD, professor of biochemistry and molecular biology.
Project 2: Little cigars
Project 2 will investigate the potential toxicity related to oxidant production in little cigars (like Swisher Sweets), as well as any product design features that might affect human exposure.
This project is led by Muscat.
Project 3: Nicotine pouches
Project 3 is led by Foulds and it comprises a randomized controlled clinical trial to investigate the effects of smokers using nicotine pouches to reduce their cigarette smoking.
Some of the TCORS studies are expected to get underway this spring. Anyone interested in participating in these studies or others led by the center can fill out this screening form or call 844-207-6392 for details.