For the reader with any interests in snus and snus science, please note that the TPSAC references below are not unimportant. The same TPSAC (Tobacco Products Scientific Advisory Committee) at FDA recommended FDA against granting Swedish Match a Modified Risk Tobacco Product status for some products.
Article in it’s entirety with total credit and gratitude to Professor Brad Rodu. It is from early 2015 but has re-emerged as hugely important in lieu of the Swedish Government proposing to raise the warning levels on snus.
NIH Funding Stifles Tobacco Harm Reduction Research and Support in Academia
As a pathologist working at two large medical centers, I have studied the effects of smoking on health for over 20 years. I’ve published scores of papers on the impressive benefits of switching from cigarettes to safer, non-combustible forms of tobacco (such as Swedish snus). This strategy – called tobacco harm reduction – has vast potential for improving public health.
In countless discussions about smoking’s devastation, people ask me: “If tobacco harm reduction is a viable quit-smoking option with huge public health benefits, why don’t U.S. medical schools advocate this concept? Why are you almost alone among American university professors in openly endorsing tobacco harm reduction?”
The answer resides within a powerful government agency, the National Institutes of Health.
The NIH is the pre-eminent source of research funding for virtually all universities and medical centers; it is the cudgel in the government’s campaign to create “a world free of tobacco use.” (here). The NIH “invests nearly $30.1 billion annually in medical research for the American people,” according to its website (here). “More than 80% of the NIH’s funding is awarded through almost 50,000 competitive grants to more than 300,000 researchers at more than 2,500 universities, medical schools, and other research institutions in every state and around the world.”
The NIH hostility to tobacco harm reduction was demonstrated in 1994, when the National Cancer Institute attacked me and my university because I published an article in a scientific journal (here). Nothing has changed in 20 years. For example, a recent NIH announcement to fund research on smokeless tobacco, which is 98% safer than cigarettes, called for investigators “to develop an evidence base to inform smokeless tobacco control efforts, and to develop effective ways to limit the spread and promote cessation of smokeless tobacco use.” This prohibitionist mindset produces NIH-funded researchers who are hostile to tobacco harm reduction; the rest are cowed into silence.
It is hard to overestimate the influence of NIH funding. Universities aggressively pursue grants, and retaining NIH support is obligatory for faculty survival at most universities – influence and prestige are directly proportional to the size of one’s grants. Due to its magnitude, NIH funding is hugely influential in determining “legitimate” areas of research conducted by hundreds of thousands of university faculty throughout the U.S. The agency’s influence is compounded by the NIH peer review system, in which groups of 20 colleagues pass judgment on grant proposals, and from which emerges a nationwide network of researchers who are intolerant of politically incorrect topics like tobacco harm reduction.
NIH dollars are vitally important to faculty and to institutions. Agency grants cover direct research costs, which typically pass through the university as faculty, staff and graduate student salaries, equipment and other project-specific charges. More importantly, the NIH also covers indirect costs, which are not specific to the project but involve administration and facility support. These are negotiated by each university, and they range from 25% to 100+% of direct costs. If a principal investigator (or PI – the faculty member leading the project) gets a $1 million grant at a university with a 50% indirect cost rate, the university pockets $500,000.
How much money does the NIH spend on tobacco research? I conducted a search of the NIH Research Portfolio Online Reporting Tools (here) for the word “tobacco”. In 2014, the NIH (mainly the National Cancer, Heart Blood Lung, Drug Abuse and Mental Health Institutes) dispensed $623 million (total costs) in 1,300 grants to over 1,000 PIs at almost 300 universities, medical centers and other institutions. That works out to about $600,000 for each investigator. Few researchers will jeopardize grants of that size by doing or saying anything that conflicts with NIH dogma.
To explore the influence of NIH funding, start with members of the FDA Tobacco Products Scientific Advisory Committee. TPSAC advises the FDA about regulatory actions, including “any application submitted by a manufacturer for a modified risk tobacco product,” which is a vital part of tobacco harm reduction.
A federal judge ruled last year that members of TPSAC, including current chairman Jonathan Samet, had significant conflicts of interest in the form of funding from (1) pharmaceutical manufacturers who compete with tobacco companies for the nicotine market, and (2) lucrative contracts to testify in lawsuits against the very industry they judge. He called TPSAC’s findings and recommendations “at a minimum, suspect, and, at worst, untrustworthy.” (here)
TPSAC members also have a conflict of interest with respect to NIH funding: In 2014, six of the nine current TPSAC members had grants totaling $28 million (Table 1). Such outsized funding must be assumed to color decision-making, particularly on regulations as NIH-toxic as tobacco harm reduction.
|Table 1. NIH Support in Fiscal Year 2014 for Tobacco Projects to Members of the FDA Tobacco Scientific Advisory Committee|
|TPSAC Member||University/Institution||Total Support (million $)|
|Jonathan Samet||Southern California||8.00|
|Warren Bickel||Virginia Tech||0.39|
|Thomas Eissenberg||Virginia Commonwealth||3.91|
|Richard O’Connor||Roswell Park||0.47|
|Kurt Ribisl||North Carolina||9.21|
Followers of this blog know that major health organizations aggressively oppose tobacco harm reduction; they also receive considerable NIH funds to pursue tobacco-related projects. In 2014, the American Academy of Pediatrics received $406,000 in support of Adolescent Smoking Cessation in Pediatric Primary Care. The American Cancer Society was awarded $343,000 for Building Research and Capacity on the Economic Policy-Tobacco Control Nexus (the title was truncated in the database). The American Heart Association scored $7.5 million for its Tobacco Regulation and Addiction Center and other projects.
Another big grantee last year was the American Legacy Foundation, recipient of $2.1 million for eight projects. One of its employees, David Levy, obtained $703,000 via Georgetown University for Modeling the Policy Impact of Cigarette and Smokeless Tobacco Use on U.S. Mortality. (I will be eager to see Dr. Levy’s mortality estimate from smokeless tobacco use, as my research indicates that it is close to zero.)
Individuals at the University of California San Francisco have engaged in an aggressive campaign against e-cigarettes (examples here and here). Table 2 shows that they were awarded $12.5 million in 2014, with over half going to PI Stanton Glantz.
|Table 2. NIH Support in Fiscal Year 2014 for Tobacco Projects to Faculty at the University of California San Francisco|
|Faculty Member||Total Support (million $)|
*Also affiliated with Stanford University
I have discussed in this blog distorted research results concerning smokeless tobacco and harm reduction from several investigators, including Gregory Connolly (here and here), Christopher Haddock (here), Stephen Hecht (here and here, Irina Stepanov (here) and Robert Klesges (here and here). Together, they received $8.5 million for tobacco projects in 2014 (Table 3). Haddock and Klesges continued work on tobacco use in the military: Haddock studied Barriers to Effective Tobacco Control Policy Implementation in the U.S. Military, while Klesges was PI on a project with a particularly intimidating title: Preventing Relapse Following Involuntary Smoking Abstinence (my emphasis).
|Table 3. NIH Support in Fiscal Year 2014 for Tobacco Projects to Individuals Aggressively Campaigning Against Smokeless Tobacco|
|Faculty Member||University/Institution||Total Support (million $)|
|Christopher Haddock||National Development and Research||0.57|
The federal government, via the Department of Health and Human Services, is engaged in a coordinated, expensive campaign to create a tobacco-free society. The NIH, which contributes annually $24 billion to the American research establishment and $623 million specifically for tobacco research, strongly influences some in the academic community to vigorously oppose – and many others to ignore – tobacco harm reduction.