Conducting Tobacco Harm Reduction Research Despite Constant Headwinds

 

Sensible Medicine is a website “featuring the voices of leading physicians, scientists, and thinkers.  The goal of Sensible Medicine is to showcase a range of ideas and opinions about all things bio-medicine.”  Recently I was honored when the editors published my article, “Six Urban Myths About Smoke-Free Nicotine.

The publication drew several courteous and intelligent comments, including an inquiry about my funding:

“…transparency around funding is important. A quick search suggests your research has received support from tobacco and nicotine companies. While that doesn’t necessarily impact the validity of your conclusions, some might see it as a source of bias. Of course, I may have missed something, but I’m curious…Should researchers with industry ties be more upfront? And how do we ensure strong research isn’t dismissed solely because of its funding source? I’d love to hear your thoughts.”

My response:

“I have conducted and published research on tobacco harm reduction since 1994 (https://louisville.app.box.com/file/1793592529260?s=ztqsq1ue1bdisllarvhpmi2ogrrvvjzj), and my funding has been a matter of public record for the entire period. From 1999 to 2018 my research was supported by unrestricted grants to the University of Alabama at Birmingham (UAB, 1999-2005) and to the University of Louisville (UofL, 2005-2018), which were publicly acknowledged. I now report no conflict of interest (COI), as six years without industry funding is a longer period than specified by the COI policies of professional journals and other relevant organizations. I have no personal or other professional conflict of interest.”

University research funding has been a hot topic in the national press recently due to a Trump Administration proposal to reduce indirect cost payments to universities to 15% of direct research costs.  I won’t comment on that proposal, but I will explain basic facts about faculty life in a research university medical school.

Medical school faculty members are expected to contribute to the university’s mission: teaching, service and research.  Their salaries are partitioned according to their percentage time commitment to those three components.  While the first component, teaching, is ostensibly paid for by tuition money and/or state support, teaching is low on the mission list because it doesn’t generate income; service and research are the income-earners.  Faculty prestige and salary are based on how many dollars one can generate from outside sources.

I started at UAB in 1979 in a cancer fellowship, and in 1981 I was an assistant professor in the department of pathology.  I had a heavy teaching load: hundreds of hours of contact time all year long with dental and dental hygiene students, as well as dental, oral pathology and medical residents.  Fifty percent of my time was paid by the university for teaching; I had to cover the other half.  A quarter of my time was spent providing service.  I saw hundreds of clinic and hospital patients and examined 2,000 specimens a year under the microscope, producing modest amounts of money for the school.  The final 25% was for research, and this is where I struggled.  I never was the principal investigator of a coveted R01 research grant from NIH, which provides money for supplies, salaries and lucrative indirect payments to administrators.  I survived with a small salary offset as co-investigator on other faculty members’ grants, and I conducted and published research on my own time.

My first study on tobacco harm reduction, which I did on my own time with no financial support, was published in Nature in 1994.  Epidemiologist Philip Cole and I found that the average loss in life expectancy from smokeless tobacco use was 15 days, compared with a loss of eight years for smokers.  One colleague noted, “A publication in Nature can make a career!” and he was right.  The publication made my career… miserable. 

My surprising, counterintuitive Nature report conflicted with mainstream medicine’s opinion that smokeless tobacco was a mouth cancer death sentence.  A point-counterpoint appearance on Good Morning America (here) was quickly followed by denunciation of me and of UAB by the nation’s primary source of research funding, the National Cancer Institute (complete story here).  NCI, asserting that telling smokers about safer ways to consume nicotine/tobacco was unethical, suggested that UAB was wrong having me on its faculty, and the agency filed a complaint with the federal office protecting patients from undue research risk.  It was an existential allegation that was proven baseless, but it led to three dreadful years of intense scrutiny (story here).

After my credibility and reputation was restored at UAB, it was clear that my important research was never going to be funded by NIH.  Using minimal financial support from the university, I continued to publish studies until around 1998, when my chairman gave me an ultimatum: while he was supportive of my work, I had to attract outside funding or my career would suffer.

I was at a crossroads.  Either obtain outside funding and continue to work on tobacco harm reduction, or abandon the field entirely.  After long discussions with Dr. Cole, I chose the former.

In 1999, the U.S. Tobacco Company signed an agreement with UAB to support my THR research for five years.  The funds constituted an unrestricted “gift” (in IRS terminology), meaning UST had no expectation or control regarding any work product.  While 100% of gifts go to the researcher’s program, and 0% to indirect costs, I was able to partition 50% of my salary for THR research, enabling me to transfer some of my teaching to my colleagues.  It also allowed me to conduct my research sabbatical in Sweden in 2002, resulting in a series of published studies examining how snus products made by Swedish Match, the major competitor of UST at that time, had made Sweden a THR model for the rest of the world. 

In 2005, I retired from the Alabama system and moved to a new position at the University of Louisville Brown Cancer Center.  My new boss, Cancer Center Director and THR supporter Dr. Donald Miller, duplicated my UAB support structure at UofL.  From 2005 to 2018, my research was supported by grants from industry to UofL.  I was fortunate to obtain funding for my entire program until 2018, when my last unrestricted grant from tobacco manufacturers to UofL ended. 

My groundbreaking work in THR would not have been possible without the support of leadership at two universities who believed in the validity and value of my research, and who had confidence in the legitimacy of accepting and administering grants from controversial sources.

Academia in the U.S. is a pressure cooker for faculty who are required to attract funding from external sources.  Excluding small grants from pharma and medical device companies, the only game in town is NIH.  When NIH makes a researcher non gratis, it poses an existential threat.  I took the only other opportunity, producing and publishing as much as possible, using the proceeds of unrestricted corporate gifts to my university employers.        

Judith Curry Perfectly Describes a Bad Recipe for Tobacco Science

 

Judith Curry is a brilliant American climatologist and former Chair of the School of Earth and Atmospheric Sciences at Georgia Tech.  The author of over a hundred scientific papers, she served on many high-level government panels: the National Research Council's Climate Research Committee; NASA’s Advisory Council Earth Science Subcommittee; the National Oceanic and Atmospheric Administration’s Climate Working Group; and the National Academies’ Space Studies Board and Climate Research Group. 

Professor Curry publishes a blog, Climate Etc., which “provides a forum for climate researchers, academics and technical experts from other fields, citizen scientists, and the interested public to engage in a discussion on topics related to climate science and the science-policy interface.”

Her recent blog entry, “A Bad Recipe For Science,” which addresses political corruption of science generally, perfectly describes the terrible recipe to undermine tobacco harm reduction that has been concocted by the World Health Organization and its partners.  Following are excerpts from the blog, with my added tobacco harm reduction-related emphasis and [note]. 

__________________________________________________________________

Politically-motivated manufacture of scientific consensus corrupts the scientific process and leads to poor policy decisions

An essay with excerpts from my new book Climate Uncertainty and Risk.

In the 21st century, humankind is facing a myriad of complex societal problems that are characterized by deep uncertainties, systemic risks and disagreements about values. Climate change and the Covid-19 pandemic are prominent examples of such wicked problems. For such problems, the relevant science has become increasingly like litigation, where truth seeking has become secondary to politics and advocacy on behalf of a preferred policy solution.

How does politics influence the scientific process for societally relevant issues? Political bias influences research funding priorities, the scientific questions that are asked, how the findings are interpreted, what is cited, and what gets canonized.  Factual statements are filtered in assessment reports and by the media with an eye to downstream political use.

How does politics influence the behavior of scientists? There is pressure on scientists to support consensus positions, moral objectives and the relevant policies.  This pressure comes from universities and professional societies, scientists themselves who are activists, journalists and from federal funding agencies in terms of research funding priorities. Because evaluations by one’s colleagues are so central to success in academia, it is easy to induce fear of social sanctions for expressing the ideas that, though not necessarily shown to be factually or scientifically wrong, are widely unpopular.

Activist scientists use their privileged position to advance moral and political agendas. This political activism extends to the professional societies that publish journals and organize conferences. This activism has a gatekeeping effect on what gets published, who gets heard at conferences, and who receives professional recognition. Virtually all professional societies whose membership has any link to climate research have issued policy statements on climate change, urging action to eliminate fossil fuel emissions.

The most pernicious manifestation of the politicization of science is when politicians, advocacy groups, journalists, and activist scientists intimidate or otherwise attempt to silence scientists whose research is judged to interfere with their moral and political agendas.

The road ahead requires moving away from the consensus-enforcing and cancel culture approach of restricting dialogue surrounding complex societal issues such as climate change [and smoking-related mortality]. We need to open up space for dissent and disagreement.  By acknowledging scientific uncertainties in the context of better risk management and decision- making frameworks, in combination with techno-optimism, there is a broad path forward for humanity to thrive in the twenty-first century and beyond.

 

 

 

Stanton Glantz’s Tainted Science: The Rest of the Story

 

Journalist Marc Gunther recently authored articles for Undark (here) and Medium (here) about “The tainted science of Stanton Glantz.” 

It is evident that Gunther interviewed or corresponded with numerous Glantz research critics. Gunther’s sources include the author of this blog, who provided extensive documentation of Glantz’s questionable work. However, since Gunther fails to tell the whole story, I will provide the rest of it here.

Fake Heart Attacks

The most important items in Gunther’s articles are his descriptions of Glantz’s flawed heart attack study that appeared in the Journal of the American Heart Association – a work that was retracted eight months after its publication in June 2019. Gunther described that study and its repercussions in his Undark article as follows:

“…when describing the second study, published in 2019 in the Journal of the American Heart Association, Glantz said it provided ‘more evidence that e-cigs cause heart attacks.’… Critics pounced on what they called glaring flaws in the analyses. Some of the e-cigarette users had previously smoked, for example, muddying the correlation. Brad Rodu, a University of Louisville professor who has numerous and longstanding connections to the tobacco industry, dug into the raw data and found that at least 11 of the 38 heart-attack victims cited in the Journal of the American Heart Association study had suffered their heart attacks before they started vaping — some as many as 10 years before. Glantz was made aware of the temporality problem before publication because it was raised by a peer reviewer, the journal’s editor subsequently realized.

 

“Sixteen tobacco researchers wrote to the journal editor asking for a retraction, and the Journal of the American Heart Association ultimately did just that — something it has done only a handful of times in its history. Its editor, though, was careful to state in a letter to Glantz that ‘the retraction notice is intentionally absent of any language suggesting scientific misconduct.’

 

“Andrew Gelman, a professor of statistics at Columbia University who followed the controversy on his blog, was unimpressed with Glantz’s response to the retraction, calling it ‘anti-scientific.’ He wrote: ‘If someone points out an error in your work, you should correct the error and thank the person. Not attack and try to salvage your position with procedural arguments.’”  

Gunther is correct: I had discovered that Glantz deliberately deceived the journal’s editors and readers by counting heart attacks before people had vaped. My comments on this appeared in a USA Today article by Jayne O’Donnell on July 17, 2019. O’Donnell wrote, “However, when Rodu obtained the federal data, he found the majority of the 38 patients in the study who had heart attacks had them before they started vaping — by an average of 10 years earlier. In his letter to the editors [dated July 11, 2019], Rodu called Glantz's findings ‘false and invalid…Their analysis was an indefensible breach of any reasonable standard for research on association or causation…We urge you to take appropriate action on this article, including retraction.’” (emphasis added) 

As noted, I publicly called for a retraction on July 17, 2019. But Gunther credited the retraction to “sixteen tobacco researchers,” linking to a letter they wrote to the journal editor on January 20, 2020. In the USA Today article I also called for a federal investigation, and I followed up a year later with a full analysis of the fraudulent findings, which was published in the journal Addiction (discussed here). 

Gunther correctly cited influential statistician Andrew Gelman. I had corresponded with Gelman in 2018 about Glantz’s woefully defective Pediatrics study, which also elicited a retraction demand from me (here, here, here and here). Gelman’s account of our correspondence is here (see Episode 1). Three months before Pediatrics retracted the study, Gelman ran the analysis of it that I had recommended to researchers world-wide in November 2019. 

In his Medium article, Gunther identifies a group of “respected veterans of the anti-smoking movement (Steven Schroeder, Ken Warner, David Abrams, Raymond Niaura and [Michael] Siegel),” and he provided links to their university profiles. Later in the article, he attributes the JAHA retraction to “other scholars”, followed by a comment from me, who he characterizes again with “whose work has been supported by the tobacco industry.” Gunther makes no mention of my 27 years of research into tobacco harm reduction, and provides no link to my university webpage profiles (here and here). 

Perhaps Gunther was influenced by the established (anti-) tobacco research and policy community, some of whom switched to support safer products only after e-cigarettes became popular. Gunther writes that they tolerated Glantz’s defective studies.

“‘Stan has always been an advocate and ideologue willing to twist the science,’ says David Abrams, a New York University professor and veteran tobacco researcher. He says that some scientists ignored flaws in his work when Glantz focused on combustible tobacco because they, too, strongly opposed smoking. ‘Frankly, none of us cared if he was a little bit sloppy with his research because the ends justified the means,’ Abrams says.” 

I never tolerated Glantz’s flaws and sloppy research, and I published numerous critical comments in journal forums and in my blog starting in 2004. Gunther mentioned two examples but did not acknowledge the active role I played in correcting Glantz’s record.

Fake Teen Gateway

Gunther’s biggest error is his description of Glantz’s “2018 study in Pediatrics, [which] also claimed that e-cigarette usage encourages more young people to smoke…a gateway effect, but the alleged link between vaping and smoking disappeared when other teen behaviors, such as using marijuana, were taken into account.”

I replicated that study’s analysis and proved that Glantz’s team had fabricated false results, which I described in detail in a letter to the editors that included a call for retraction (here). That led to an extended exchange with Glantz and Pediatrics editors, with the latter going to great lengths to defend the flawed research (here, here and here).   

The “Helena Miracle”

Gunther noted the “Helena miracle”, in which Glantz credited public smoking bans for a decrease in hospital admissions for heart attacks in the small Montana town. Gunther wrote, “The small sample size in Helena — four cases per month during the ban, compared to seven beforehand — should have raised red flags; random fluctuations could have explained the drop in hospital admissions.” As I had told Gunther, bright red flags were raised by me in comments to the BMJ in 2004 (here) and 2006 (here). My analysis showed that the number of hospital admissions in Helena and other miracle localities was so small that “the relevant question is whether [the Helena] report involves anything more than random variation.” (here)

I attempted to reproduce Glantz’s tiny city reports by conducting an analysis using state-wide data. My study, published in 2011 (discussed here), was subsequently referenced by other researchers (here). I found that rates of death due to heart attacks in states with smoking bans were no different than those in states with no ban, and that heart attacks had been declining everywhere for years. The last point is something Glantz never took into account; in fact, he freeloaded his second-hand smoke heart-attack results on the decades-long downward trend in heart attack rates.

Fake “Softening” of the Smoking Population

In 2015, Glantz proclaimed in Tobacco Control that there is no public health basis for advising smokers that smokeless tobacco and e-cigarettes are safer cigarette alternatives, because the smoking population in the U.S. was “softening”, i.e., becoming more likely to quit (abstract here). Once again, I found that his analysis was seriously flawed, as he failed to consider a number of other significant factors. My research group recreated his analysis and took into account the missing factors; we found that Glantz’s “softening” disappeared.  We published our study in the journal Addiction (discussed here). 

Other Glantz Publication Problems

Glantz Redefined Youth Smoking, 2014  https://rodutobaccotruth.blogspot.com/2014/04/ucsf-redefines-youth-smoking-journals.html

Glantz Falsely Linked E-Cigarettes to Smoking, 2014 https://rodutobaccotruth.blogspot.com/2014/03/ucsf-study-falsely-links-e-cigarettes.html

Glantz Misrepresented IQOS Studies to the FDA, 2017 https://rodutobaccotruth.blogspot.com/2017/11/smoke-but-no-fire-iqos-opponent.html

Glantz Used Complicated Models to Try to Change NYTS Data, 2017 https://rodutobaccotruth.blogspot.com/2017/02/complicated-models-cant-alter-data.html

https://rodutobaccotruth.blogspot.com/2017/02/complicated-models-cant-alter-data-part.html

Glantz’s Failed Attempt to Link Teen Smoking to Cinematic Smoking, 2017 https://rodutobaccotruth.blogspot.com/2017/08/teen-smoking-unconnected-to-cinematic_30.html

Another E-Cigarette Gateway Claim by Glantz Based on Tiny Numbers, 2018 https://rodutobaccotruth.blogspot.com/2018/04/another-uc-san-francisco-e-cigarette.html

Trace Toxins in Teens Improperly Blamed on E-Cigarettes, 2018 https://rodutobaccotruth.blogspot.com/2018/03/beyond-headlines-trace-toxins-present.html

Federal Funds Misspent on Glantz’s Research, 2020 https://rodutobaccotruth.blogspot.com/2020/02/federal-funds-misspent-on-anti-vaping.html

 

Since 2006, the National Institutes of Health has funneled $51 million to Glantz at the University of California San Francisco. In addition to the flawed heart attack work, which may be viewed as research misconduct using federal funds, he published 300 other articles. I list above only the worst offenders and note my attempts to correct them.