Blog | Wednesday, December 14, 2011

QD: News Every Day--E-cigarettes should require third-party health and safety reviews

Modified risk tobacco product manufacturers should consider using FDA-approved, independent third parties to oversee health and safety research on their products, according to an Institute of Medicine report.

Such studies should look at each product's 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, the report continued.

Studies should be reflect the entire population and should also include current and former smokers, beginning smokers and teens, and groups at high risk for tobacco use.

"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," the Institute of Medicine said in a release. "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."

Cigarette use is 20.6% among adults and 19.5% in youth, rates that have been static since the late 1990s, the report said. Of the 46 million adult smokers in the United States, an estimated 70% want to stop. While 45% try to stop during the course of a year, only 6% succeed for one month or more.

Modified risk tobacco products such as e-cigarettes and lozenges could be one part of a comprehensive strategy, especially among the most reluctant to quit, but too little is known about the products' health effects and whether they pose less risk than traditional tobacco 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 the FDA that the product will not only reduce harm to individuals, but also benefit the population as a whole.

While the companies usually do their own FDA safety studies, the tobacco industry lacks the capacity and expertise to do so, the report says. And, the industry's history of improper manipulation of data undermined its credibility and isolated it from the mainstream scientific community, the IoM release said. Many major universities won't accept tobacco funding, and many high-impact scientific and medical journals won't accept manuscripts supported by the tobacco industry.

Transparency would also build trust, the IoM said. 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.