FDA considers an independent body to monitor tobacco research

Thomson Reuters

By Jacob Hale Russell

(Reuters) – The Federal Drug Administration is considering a recommendation that an independent body should monitor some research put to the agency by tobacco companies, underscoring the growing concern about conflicts of interest in scientific research.

The recommendation was submitted by the Institute of Medicine, a scientific research organization that’s part of the National Academy of Sciences, and is based on its 2011 report. It suggests that any research provided to the FDA by manufacturers of so-called modified-risk tobacco products, which companies want to market as “less” risky, should be overseen by an independent body.

Under the Family Smoking Prevention and Tobacco Control Act of 2009, the FDA must consult with the Institute of Medicine on the regulation of these products. The law allows the FDA to approve them only if research demonstrates their health benefits.

Although it is far from certain the FDA would mandate the creation of an independent overseer, mostly because there is no consensus on how it would work, there are other possible courses of action.

The FDA might adopt informal guidance that would pressure the tobacco industry to voluntarily fund one or more independent oversight groups, said Daniel Carpenter, a Harvard government professor who was on the committee that authored the 2011 report.

“(Tobacco has) basically competed on price and a whole bunch of other things, not legitimacy grounds,” said Carpenter, drawing a comparison to pharmaceutical regulation, where drugmakers compete with each other to produce trustworthy research.

“One productive thing that might come out of this is to incentivize a degree of credibility competition among tobacco companies,” he said.

On March 19 and 20, the FDA held a workshop in Maryland, attended by industry and public-health researchers, to consider the institute’s proposal. Third parties, it said, should design and conduct research, oversee studies and distribute sponsor funds for research.

Such steps are necessary because of the tobacco industry’s “history of hiding and misrepresenting information about the risks of tobacco products” and lack of “expertise to produce the necessary range of credible and reliable data,” the proposal said.



Michael Ogden, senior director of regulatory oversight at RAI Services, a division of RJ Reynolds Tobacco, disagreed with the premise. “If you set up the proper conduct of studies, you should not mandate who can do those studies. You establish the quality and performance criteria, and any vendor who meets those criteria should be able to be used,” Ogden said during the conference.

The institute’s report cited one model of an independent research agency, the Health Effects Institute, a non-profit funded by the automobile industry and the federal government. That group, it said, has helped produce credible research in the controversial field of air pollution, but in a departure from the Institute of Medicine’s proposal, it does not release studies on specific products, only on general issues of public health and air quality.

In recent years, public-policy experts have expressed concern that some scientific researchers are compromised by financial incentives. For instance, medical journals have come under fire for insufficient disclosure of researchers’ investments in drug companies that hire them to conduct studies.

This problem is worse in the tobacco context because the government and public-health experts have lost trust in the tobacco industry, and few top universities accept funding from the sector to conduct research, said Carpenter.

If the FDA or the tobacco industry embraced the institute’s idea for third party oversight, the research would be separated from those who fund it.

To date, the FDA has sought to eliminate conflicts of interest in pharmaceutical research by requiring disclosure of financial incentives, though it’s unclear how, if at all, disclosure has affected the FDA’s approval process of pharmaceuticals, said Jeffrey Gibbs, a lawyer with Hyman, Phelps & McNamara who represents healthcare companies before the FDA.

“What the FDA does with these disclosures is unknown to industry and the outside world,” said Gibbs. It is unlikely that the FDA would change the structure by which pharmaceutical companies do research, he said.

But Scott Ballin, an attorney and health-policy consultant who presented at last week’s conference, argued that the FDA should treat all scientific research the same.

“We’re talking about setting standards and integrity that should be across-the-board, whether it’s tobacco, pharmaceuticals, medical devices, food companies or anybody else,” he said. “We shouldn’t be treating tobacco as so unique anymore, now that they’re under a regulatory authority.”


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