The success of anti-smoking initiatives has fostered an avalanche of alternative tobacco products that claim or imply that they are a safer option. However, independent evaluation of the safety of the new products has not been performed.
The alternative products, collectively called “potential reduction exposure products” or PREPs, include “safer” tobacco or nicotine delivery systems which range from low nicotine cigarettes and cigarettes that heat tobacco instead of burn it, to nicotine mints that are now available, and little bags of tobacco, currently being test marketed in the U.S., that users place beneath their upper lip.
Investigation of the products will be lead by a nationwide consortium of researchers, headquartered in Georgetown University Medical Center. GUMC scientists have been awarded a five-year, he first of its kind, $17 million grant by the National Cancer Institute (NCI) to determine if alternative tobacco products reduce health risks as they either overtly claim to or subtly imply.
“Consumers should know if these products truly reduce exposure to carcinogens, and experience tells us this information will not be either forthcoming from the companies that manufacture them, or that we need independent verification of claims,” said the grant’s lead scientist, Peter Shields, M.D., a Georgetown professor of Medicine and Oncology and Director of Cancer Genetics and Epidemiology at the Lombardi Comprehensive Cancer Center.
Figuring out if these products will actually reduce exposures, with the implication that they are safer, is not a simple task, Shields said. These researchers will develop new methods to evaluate and develop new methods for testing tobacco products, and help other researchers learn the best ways to do their research, he said. They also will provide information to smokers so that they can make more informed choices.
“Some of these companies are being careful about not making health claims, while others are already making claims, so we feel it is a public health priority to find out what these products are all about, how people will use them, and how they will affect exposure to tobacco smoke,” Shields said.
Recently, Congress has been considering legislation that will allow the Food and Drug Administration (FDA) to have authority over the labeling of these products, he said. “If that happens, this work can assist the FDA in their deliberations,” Shields said.
The consortium includes researchers from Georgetown University, University of Minnesota, Harvard Medical School, Roswell Park Cancer Institute in Buffalo, New York, and Arista Laboratories in North Carolina, among others.
The study will examine all aspects of these alternatives, collectively called “potential reduction exposure products” or PREPs, from design and chemistry to toxic exposure, and will communicate all findings to the public, Shields said. “We will provide rapid assessments of new products as they come on the market,” he said.
To do that, the multidisciplinary researchers, who have dubbed themselves PREPAC (PREP Assessment Consortia), have divided themselves into teams. Researchers at Georgetown and the University of Minnesota will conduct clinical studies of participants who volunteer to use these products, as well as traditional cigarettes and will develop molecular markers of toxic exposure; Arista Laboratory and Georgetown researchers will analyze the toxicity of the products; investigators at Arista and Roswell will study the product design; and researchers at Harvard and Roswell Park will consider the perception of consumers to these products, and will examine tobacco company documents, including testing reports and patents.
New legislation passed recently in the District of Columbia that provides for smoke-free workplaces contained an exemption for research, “giving Lombardi Comprehensive Cancer Center the ability to conduct studies for this contract,” Shields said. “The D.C. city council was very cooperative with our request to allow research of this kind.”
Some of these researchers have already been working together to study Quest, a cigarette that contains less nicotine than traditional cigarettes.
Shields said the public health community is divided over use of these “safer” alternatives, which includes advocating the use of smokeless tobacco as a safer alternative to smoking. Some experts feel any reduction in risk is beneficial, while others feel that no tobacco should be the only position of the public health community. “There is a danger that may be broader than that for the individual smoker,” Shields said. “A lot of former smokers who still crave nicotine may start to use these new cigarette products or smokeless tobacco. Current smokers may decide not to quit, thinking that they have an alternative that is safe enough.”