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.