Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

New report identifies research needed on 'modified risk' tobacco products

15.12.2011
A new Institute of Medicine report specifies the types of research that the Food and Drug Administration should require before allowing tobacco companies to sell or advertise 'modified risk' tobacco products as being capable of reducing the health risks of tobacco use.

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
Contacts: Bill Kearney, Director of Media Relations
Lauren Rugani, Media Relations Officer
Office of News and Public Information
202-334-2138; e-mail news@nas.edu
Copies of Scientific Standards for Studies on Modified Risk Tobacco Products will be available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu. Reporters may obtain a pre-publication copy from the Office of News and Public Information (contacts listed above).

[ This news release and report are available at http://national-academies.org ]

INSTITUTE OF MEDICINE
Board on Population Health and Public Health Practice
Committee on Scientific Standards for Studies on Modified Risk Tobacco Products
Jane E. Henney, M.D. (chair)
Professor of Medicine and Public Health Sciences
College of Medicine
University of Cincinnati
Cincinnati
Timothy B. Baker, Ph.D.
Professor of Medicine, and
Associate Director
Center for Tobacco Research and Intervention
University of Wisconsin
Madison
Rebecca Bascom, M.D., M.P.H.
Professor of Medicine
Milton S. Hershey Medical Center
Pennsylvania State University
Hershey
Shyam Biswal, Ph.D.
Associate Professor
Department of Environmental Health Sciences
Johns Hopkins Bloomberg School of Public Health
Baltimore
Daniel Carpenter, Ph.D.
Allen S. Freed Professor of Government, and
Director
Center for American Political Studies
Center for Government and International Studies
Harvard University
Cambridge, Mass.
Constantine Gatsonis, Ph.D.
Professor of Medical Science and Applied Math, and
Director
Center for Statistical Sciences
Brown University
Providence, R.I.
Gary H. Gibbons, M.D. (resigned October 2011)
Professor of Medicine, and
Director
Cardiovascular Research Institute
Morehouse School of Medicine
Atlanta
Bonnie L. Halpern-Felsher, Ph.D.
Professor
Department of Pediatrics
Division of Adolescent Medicine
University of California
San Francisco
Stephen S. Hecht, Ph.D.
Professor and Chair in Cancer Prevention
Department of Medicinal Chemistry
Cancer Center
University of Minnesota
Minneapolis
Peter K. Honig, M.D., M.P.H.
Head
Global Regulatory Affairs
AstraZeneca
Collegeville, Pa.
Richard O'Connor, Ph.D.
Associate Member
Department of Health Behavior
Roswell Park Cancer Institute
Buffalo, N.Y.
Joel L. Schwartz, D.M.D., D.M.Sc.
Professor of Oral Medicine and Pathology
Colleges of Dentistry and Medicine
University of Illinois
Chicago
Donna-Bea Tillman, Ph.D., M.P.A.
Director of Regulations and Policy
Health Solutions Group
Microsoft Corp.
Chevy Chase, Md.
Alastair J. Wood, M.D., F.A.C.P.
Managing Director
Symphony Capital
New York City
Anna H. Wu, Ph.D. (resigned June 2011)
Professor
Preventive Medicine
Division of Epidemiology
University of Southern California
Los Angeles
STAFF
Joel Wu, J.D., M.P.H., M.A.
Study Director

Bill Kearney | EurekAlert!
Further information:
http://www.nas.edu

More articles from Health and Medicine:

nachricht Cholesterol-lowering drugs may fight infectious disease
22.08.2017 | Duke University

nachricht Once invincible superbug squashed by 'superteam' of antibiotics
22.08.2017 | University at Buffalo

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Fizzy soda water could be key to clean manufacture of flat wonder material: Graphene

Whether you call it effervescent, fizzy, or sparkling, carbonated water is making a comeback as a beverage. Aside from quenching thirst, researchers at the University of Illinois at Urbana-Champaign have discovered a new use for these "bubbly" concoctions that will have major impact on the manufacturer of the world's thinnest, flattest, and one most useful materials -- graphene.

As graphene's popularity grows as an advanced "wonder" material, the speed and quality at which it can be manufactured will be paramount. With that in mind,...

Im Focus: Exotic quantum states made from light: Physicists create optical “wells” for a super-photon

Physicists at the University of Bonn have managed to create optical hollows and more complex patterns into which the light of a Bose-Einstein condensate flows. The creation of such highly low-loss structures for light is a prerequisite for complex light circuits, such as for quantum information processing for a new generation of computers. The researchers are now presenting their results in the journal Nature Photonics.

Light particles (photons) occur as tiny, indivisible portions. Many thousands of these light portions can be merged to form a single super-photon if they are...

Im Focus: Circular RNA linked to brain function

For the first time, scientists have shown that circular RNA is linked to brain function. When a RNA molecule called Cdr1as was deleted from the genome of mice, the animals had problems filtering out unnecessary information – like patients suffering from neuropsychiatric disorders.

While hundreds of circular RNAs (circRNAs) are abundant in mammalian brains, one big question has remained unanswered: What are they actually good for? In the...

Im Focus: RAVAN CubeSat measures Earth's outgoing energy

An experimental small satellite has successfully collected and delivered data on a key measurement for predicting changes in Earth's climate.

The Radiometer Assessment using Vertically Aligned Nanotubes (RAVAN) CubeSat was launched into low-Earth orbit on Nov. 11, 2016, in order to test new...

Im Focus: Scientists shine new light on the “other high temperature superconductor”

A study led by scientists of the Max Planck Institute for the Structure and Dynamics of Matter (MPSD) at the Center for Free-Electron Laser Science in Hamburg presents evidence of the coexistence of superconductivity and “charge-density-waves” in compounds of the poorly-studied family of bismuthates. This observation opens up new perspectives for a deeper understanding of the phenomenon of high-temperature superconductivity, a topic which is at the core of condensed matter research since more than 30 years. The paper by Nicoletti et al has been published in the PNAS.

Since the beginning of the 20th century, superconductivity had been observed in some metals at temperatures only a few degrees above the absolute zero (minus...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Call for Papers – ICNFT 2018, 5th International Conference on New Forming Technology

16.08.2017 | Event News

Sustainability is the business model of tomorrow

04.08.2017 | Event News

Clash of Realities 2017: Registration now open. International Conference at TH Köln

26.07.2017 | Event News

 
Latest News

Cholesterol-lowering drugs may fight infectious disease

22.08.2017 | Health and Medicine

Meter-sized single-crystal graphene growth becomes possible

22.08.2017 | Materials Sciences

Repairing damaged hearts with self-healing heart cells

22.08.2017 | Life Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>