While modified risk tobacco products could be one part of a comprehensive strategy to lower tobacco-related death and disease in the U.S., especially among tobacco users who are unable or unwilling to quit entirely, little is currently known about the products' health effects and whether they pose less risk than traditional tobacco products. Examples of modified risk tobacco products may include e-cigarettes and tobacco lozenges.
Companies and other sponsors developing modified risk tobacco products should consider using FDA-approved independent third parties to oversee health and safety research on their products, adds the report, which was completed to fulfill a congressional mandate. Independent oversight would ensure that the data submitted to FDA are reliable and credible, and it could help re-engage the mainstream scientific community in research. Because of the tobacco industry's well-documented history of improper conduct, many institutions and scientists currently refuse to conduct or publish research supported by the tobacco industry.
"Right now there's a shortage of scientific evidence on the health effects of modified risk tobacco products, and the tobacco industry currently lacks the trustworthiness, expertise, and infrastructure to produce it," said Jane Henney, chair of the committee that wrote the report, and professor of medicine and public health sciences at the University of Cincinnati. "Having trusted third parties oversee the conduct of research could help re-engage scientists and enable generation of credible research data on the health effects of these products."
The Family Smoking Prevention and Tobacco Control Act of 2009 requires that modified-risk tobacco products undergo a pre-market approval process similar to drugs and devices. According to the act, a company that wants to market a lower risk tobacco product in the U.S. must offer scientific proof to FDA that the marketing of the product will not only reduce harm to individual users, but also benefit the health of the population as a whole. The act also directed FDA to consult with IOM on how scientific studies of modified risk tobacco products should be designed and conducted.
The IOM's report says that the studies should examine all of the areas needed to forecast and monitor a proposed product's impact on public health, including its composition and addiction potential; the amount of human exposure to harmful components; perceptions about the product's effects and likelihood of addiction; and effects on human health. Studies should be generalizable to the whole population and should also include populations of special relevance, including current and former smokers, beginning smokers, adolescents, and populations at high risk for tobacco use.
While studies submitted to FDA to demonstrate products' safety are usually conducted or sponsored by the companies themselves, the tobacco industry at present lacks the capacity and expertise to conduct such research, the report says. The industry's history of improper manipulation of data undermined the credibility of its research and left it isolated from the mainstream scientific community. Many major universities have policies against acceptance of tobacco funding, for example, and many high-impact scientific and medical journals will not accept manuscripts supported by the tobacco industry.
Using independent, FDA-approved third parties to conduct, provide oversight of, and distribute funding for research could distance the influence and reputation of the tobacco industry from the scientists who are researching their products. Examples of third-party partnerships between industry and government include the Health Effects Institute and the Reagan-Udall Foundation. No similar organization currently exists for the tobacco industry.
Making data publicly available will also build public trust and will allow for independent analysis of data and methods, the report says. FDA should require sponsors of modified risk tobacco products to place all data generated during a product's development and marketing in a public repository selected by the agency.
FDA should also require that studies offered in support of an application to market modified risk tobacco products conform to established standards of good research governance, including appropriately qualified investigators, transparency, independent institutional review board or ethical review, and adherence to federal regulations that ensure the protection of human participants in biomedical research.
The study was sponsored by the Food and Drug Administration. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. For more information, visit http://national-academies.org or http://iom.edu. A committee roster follows.Date: Dec. 14, 2011
[ This news release and report are available at http://national-academies.org ]INSTITUTE OF MEDICINE
Bill Kearney | EurekAlert!
Tuberculosis: New drug substance BTZ-043 is being tested on patients for the first time
11.12.2019 | Klinikum der Universität München
Lighting up cardiovascular problems using nanoparticles
10.12.2019 | University of Southern California
In a joint experimental and theoretical work performed at the Heidelberg Max Planck Institute for Nuclear Physics, an international team of physicists detected for the first time an orbital crossing in the highly charged ion Pr⁹⁺. Optical spectra were recorded employing an electron beam ion trap and analysed with the aid of atomic structure calculations. A proposed nHz-wide transition has been identified and its energy was determined with high precision. Theory predicts a very high sensitivity to new physics and extremely low susceptibility to external perturbations for this “clock line” making it a unique candidate for proposed precision studies.
Laser spectroscopy of neutral atoms and singly charged ions has reached astonishing precision by merit of a chain of technological advances during the past...
The ability to investigate the dynamics of single particle at the nano-scale and femtosecond level remained an unfathomed dream for years. It was not until the dawn of the 21st century that nanotechnology and femtoscience gradually merged together and the first ultrafast microscopy of individual quantum dots (QDs) and molecules was accomplished.
Ultrafast microscopy studies entirely rely on detecting nanoparticles or single molecules with luminescence techniques, which require efficient emitters to...
Graphene, a two-dimensional structure made of carbon, is a material with excellent mechanical, electronic and optical properties. However, it did not seem suitable for magnetic applications. Together with international partners, Empa researchers have now succeeded in synthesizing a unique nanographene predicted in the 1970s, which conclusively demonstrates that carbon in very specific forms has magnetic properties that could permit future spintronic applications. The results have just been published in the renowned journal Nature Nanotechnology.
Depending on the shape and orientation of their edges, graphene nanostructures (also known as nanographenes) can have very different properties – for example,...
Using a clever technique that causes unruly crystals of iron selenide to snap into alignment, Rice University physicists have drawn a detailed map that reveals...
University of Texas and MIT researchers create virtual UAVs that can predict vehicle health, enable autonomous decision-making
In the not too distant future, we can expect to see our skies filled with unmanned aerial vehicles (UAVs) delivering packages, maybe even people, from location...
03.12.2019 | Event News
15.11.2019 | Event News
15.11.2019 | Event News
11.12.2019 | Materials Sciences
11.12.2019 | Information Technology
11.12.2019 | Life Sciences