Tobacco Harm Reduction Research & Funding Draw Ad Hominem Attack

The influential journal Science recently posted on its website an article (here) on the Foundation for a Smoke-Free World, an organization funded by a pledge of almost $1 billion from Philip Morris International.  The Foundation supports tobacco harm reduction research with a stated goal of “end[ing] the production and use of combustible cigarettes and help[ing] smokers switch to less dangerous alternatives.”  Asking, should scientists take the funding, the article clearly leans toward “no”.

The only affirmative comments included in the piece are from the Foundation’s director and me, with my response truncated by the author to this: “But public funding to help settle those questions is in short supply, says Brad Rodu, a harm reduction advocate at the University of Louisville in Kentucky who for years has relied on tobacco money.”

As I have written, government funding, predominantly from the National Institutes of Health, keeps academic research aligned with a vision of a tobacco-free society (here).  NIH’s opposition to tobacco harm reduction dates back to the mid-1990s, as seen in the agency’s efforts to undermine my research and reputation (detailed in Jacob Sullum’s book, For Your Own Good, here).

The Science writer casts me as “a harm reduction advocate…who for years has relied on tobacco money,” despite my record of 65 published professional articles (available here, with PubMed links) and 24 years of scientific endeavor, 19 of which were supported by unrestricted grants from tobacco companies to, and administered by, two universities.

Elsewhere in the story, an individual with half as many published articles is respectfully described as a “tobacco control researcher” as he terms the Foundation a “scam”.

I support academic freedom, including the right to use research funding from any lawful source, accompanied by total transparency and full disclosure.  Research ought to be judged on its merits, using objective standards of quality and accuracy.       

The Foundation director is, regrettably, prescient in anticipating “harassment of grantees and staff” and “ad hominem attacks”.  Such behavior is, as he notes, unacceptable.

FDA Advisory Committee: Heat-Not-Burn is Lower Exposure Than Smoke

The FDA Tobacco Products Scientific Advisory Committee (TPSAC) on January 25 unanimously endorsed a claim by Philip Morris International that switching completely from cigarettes to its heat-not-burn IQOS system significantly reduces smokers’ exposure to harmful and potentially harmful chemicals (here).  The committee, however, denied two other claims, that switchers “can reduce the risks of tobacco-related diseases” (8 against, 1 abstention) and that switching “presents less risk of harm” than continued smoking (5-4 against).
 

PMI published numerous short-term studies documenting that toxicant levels from IQOS aerosols were substantially lower than those in smoke, and demonstrating the biologic and medical impact of these differences in cells, animals and humans.  The committee’s denial of the diseases claim was understandable: risks manifest after three or four decades of steady smoke exposure, so risk reduction from switching to IQOS “can” occur over longer time periods. 

However, TPSAC’s close vote rejecting the reduced harm claim is problematic.     

In 2012, the FDA published a list of 93 Harmful and Potentially Harmful Constituents (HPHC) in Tobacco Products and Tobacco Smoke (here and here).  The agency declared that the HPHCs variously posed health hazards as carcinogens, respiratory toxicants, cardiovascular toxicants, reproductive or developmental toxicants, and/or addictive agents.  The agency provided no guidance for the levels of exposure that constitute harm.  This is important, as seen in the case of formaldehyde, a weak carcinogen to which nearly everyone is exposed, but smokers significantly more so (discussed here).

TPSAC rejected impressive evidence of HPHCs reduction in IQOS vapor.  I collected the following information from Appendix C of the FDA Briefing Materials (available here), which standardized toxins in IQOS aerosol and smoke according to nicotine intake.    
 
On average, the reduction in the level of all potential and proven carcinogens (n=29) in IQOS aerosol was 90%.  For the most important carcinogens (n=9), the reduction was 96%.  Average reductions in respiratory (n=18) and cardiovascular (n=8) toxicants were 91% and 93% respectively.  The reductions for all of these individual agents are illustrated in the charts that follow. 

The substantial reductions in all tested HPHCs support the claim that switching completely to IQOS “presents less risk of harm” than continuing to smoke.  There is adequate justification for the FDA to set aside TPSAC’s narrow 5-4 rejection of this claim. 

The two-day hearing raised no significant roadblocks to FDA market authorization for IQOS, which would allow U.S. sales.  Given the significant relative health benefits of this smoke-free product, market authorization is the appropriate action.