Wednesday, June 27, 2018

Vapers: Tell the FDA You’re Not Merely An Anecdote!

A year and a half ago, I blogged about government agencies ignoring federal survey data showing that 2.5 million former smokers were current vapers (here).  When FDA tobacco center director Mitch Zeller dismissed this evidence as mere “anecdotal reports,”  I argued that such data constitutes legitimate population-level evidence.

Aiming to build a fresh dataset on smokers’ success in using vapor as a quitting aid, the Vapor Technology Association (VTA) and Consumer Advocates for Smoke-Free Alternatives (CASAA) just launched a national campaign called “I Am Not An Anecdote” (here).

The groups are asking vapers to submit to the FDA detailed, sworn statements to “encourage Congress and federal regulators to reject any proposal that would ban OR limit flavored e-liquid products.” The groups note that “FDA Commissioner Scott Gottlieb has said that your ‘personal stories are important to me.’  But, he also refers to your stories of quitting cigarettes with vapor products as ‘anecdotes.’”

While individual cases are, in scientific terminology, anecdotal, their cumulative value is considerable.  Vapor is replacing combustion at dramatic rates worldwide.  My research team used 2013 FDA-funded survey data to produce a peer-reviewed report on U.S. e-cigarette use (here and here).  Our analysis showed that e-cigarettes are the most popular quit-smoking aid among American smokers and that they are the only aid more likely to make them former smokers (i.e., successful quitters) than are cold-turkey attempts (here).

FDA should give weight to published studies, even when they do not conform to visions of a tobacco-free society.  The agency should also recognize the scientific value of mass declarations of smoking cessation accomplished through vaping substitution.

Wednesday, June 20, 2018

American Cancer Society’s Combustible Tobacco Statement Contains Falsehood

The American Cancer Society’s new position statement offering a “bold new framework” for eliminating combustible tobacco use in the U.S. (here) contains a demonstrably invalid statement: “Cigarette smoking is the leading cause of cancer mortality in the United States (1), accounting for as much as 98% of all tobacco-related deaths (2) [emphasis added].

The problem with the highlighted phrase is that no estimate of “all tobacco-related deaths” in the U.S. has ever been produced by the government, academia or health organizations.  The percentage of deaths attributable to smoking, while undoubtedly large, is simply not known.

In reference 2 above, ACS attributes the false assertion to a New England Journal of Medicine article by tobacco researchers Michael Fiore, Steven Schroeder and Timothy Baker (here).  That article made virtually the same statement and cited a citizen petition submitted to the FDA in 2010 by Dr. Joel Nitzkin on behalf of the Tobacco Control Task Force of the American Association of Public Health Physicians (here).  Careful review of the Nitzkin filing reveals nothing to support the ACS or NEJM claim.

This falsehood can be corrected.  With some effort, the very small number of deaths from smokeless use and cigar/pipe smoking can be estimated from large federal datasets.  Government researchers and the ACS have the resources and should make this a priority, in order to provide a scientific foundation for FDA tobacco regulation.

Fabrication, or repetition of false statements, particularly by trusted authorities, organizations, and public figures, can result in widespread acceptance of myth as truth. Such cavalier inattention to fact is not acceptable in scientific discourse or public health policymaking, where actual lives are at stake (here).