The tobacco industry sought to unduly influence a critical think tank report commissioned a few years ago by U.S. regulators, a team of American and German researchers say.

After gaining regulatory authority over the industry, the U.S. Food and Drug Administration in 1999 commissioned the prestigious Institute of Medicine (IOM), which advises policy makers with scholarly advice, to report on the safety of new tobacco products promising lower health risks, such as "safe cigarettes" or other products mitigating the health risks of smoking.

The IOM in 2010 released the report, "Clearing the Smoke."

When asked for input by the IOM for the report, American tobacco companies devised "complex strategies" to first influence the report writers and then use conclusions to their advantage in regulatory policy proceedings. "Tobacco companies strategically interacted with the IOM to win several favored scientific and regulatory recommendations," the study authors wrote Tuesday in the journal PLOS Medicine.

The investigators specified, however, that tobacco companies acted individually to attempt to influence the IOM, rather than colluding as a group.

The IOM told Medical Daily they had no comment on the report.

In the new analysis of the 2010 IOM report, investigators reviewed previously secret documents from tobacco industry litigation, obtained from the University of California, San Francisco Legacy Tobacco Documents Library, and files made public by the IOM — but said one study limitation would be the withholding of non-public information held by tobacco companies.

The researchers said tobacco companies saw the 2010 IOM report as key to federal public health policy. When invited by the IOM to provide information on tobacco exposure and disease markers for evaluation of their own products, industry participants assembled a group of lawyers, consultants, and in-house regulatory experts to shape presentations from company scientists, the authors said.

"Although the available evidence does not permit drawing cause-and-effect conclusions, and the IOM may have come to the same conclusions without the influence of the tobacco industry, the companies were pleased with the final report," the authors wrote. "The tobacco industry has a history of producing and promoting misleading research to serve its business needs. Consistent with this history, the tobacco companies used their legal and regulatory staff to access the IOM information-sharing process and used this access to deliver specific, carefully formulated messages to serve their business interests."

Also criticized was the presumption by IOM that the health establishment and tobacco industry were both stakeholders in the process, holding polarized but equally legitimate perspectives on the matter — "a dynamic encouraged by the industry," the authors wrote. In presentations to the IOM, R.J. Reynolds Tobacco Company and Phillip Morris USA, both based in the United States, denied evidence that "low-yield" products posed a health risk, arguing with industry research data that the products were much safer than conventional tobacco products.

"Limited scientific rationales for these positions were presented," the authors wrote.

Phillip Morris then used the IOM report to lobby U.S. regulators "by quoting, and at times misinterpreting," the regulatory conclusions of the report committee, the study authors further contended.

The full report is available on the open-access journal PLOS Medicine.

 

Source: Tan CE, Kyriss T, Glantz SA. Tobacco Company Efforts to Influence the Food andDrug Administration-Commissioned Institute ofMedicine Report Clearing the Smoke: An Analysis ofDocuments Released through Litigation. PLOS ONE. 2013.