Two U.S. lawmakers voice concerns over Philip Morris tobacco trials

Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) say they have fresh concerns over clinical trials conducted by Philip Morris International as it seeks U.S. clearance to market its iQOS electronic tobacco product as less risky than cigarettes. The senators cited reports that showed problems with the trials that supported Philip Morris’s application to FDA. Blumenthal reportedly plans to send a letter to FDA Commissioner Scott Gottlieb regarding the new concerns. In October, Blumenthal, Durbin and two other Democratic senators wrote to the agency urging a thorough review of the iQOS product, warning that tobacco companies "have a long history of making false claims about the risks their products pose." Outside advisors to FDA recently said the company should not be allowed to claim the product is less risky than cigarettes based on the available data. The expert panel concluded that the product exposes users to lower levels of harmful chemicals but said the company had not shown that lowering exposure to those chemicals is reasonably likely to translate into a measurable reduction in disease or death. The recommendation is nonbinding and FDA could still allow Philip Morris to make such a claim. Some analysts think the agency might ask for additional data to do so.