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.        

The Real Cost of FDA’s “Real Cost” E-Cigarette Campaign

 

FDA staff just published a study in the American Journal of Preventive Medicine titled, “The Impact of ‘The Real Cost’ on E-cigarette Initiation among U.S. Youth.” 

The authors describe the campaign advertisements in the study’s appendix:

“Scary Enough.”  Metal monsters representing toxic metal inhalation

“Addiction Isn’t Pretty: Toilet.”  A teen reaches into a toilet to retrieve an e-cigarette thrown there by another teen, then takes a hit before walking out.

“Toxic Taxidermy.”  The interior of a taxidermy shop showing badly preserved animals who talk about formaldehyde in e-cigarettes.

“Don’t Pollute Yourself.”  A serene natural landscape where a pipeline starts dumping sludge, portraying toxic chemicals, into a lake, which is shaped like lungs.

The FDA authors used a nonpublic survey dataset to measure children’s exposure to the ads, and then they performed a “discrete-time survival analysis… to examine the impact of the exposure index on e-cigarette initiation at follow-up by using logistic regression models that controlled for the above-mentioned demographic and environmental variables.”

In other words, they estimated how many kids age 11-18 did not start using e-cigarettes because of the FDA campaign.  They said the ads prevented 444,252 children from starting to use e-cigarettes in 2023-2024, with a 95% confidence interval between 73,639 and 814,866.

Given that their estimate was more like a guesstimate, the authors should have rounded to the thousands or ten thousands. But, for this exercise, let’s assume the authors’ approach is valid, and that the ads prevented people from using e-cigarettes.  We can also assume that the effect that the authors claimed for 18-year-olds – basically adults – applies to the entire adult smoking population of nearly 27 million, per the 2023 NHIS.

Applying the authors’ analytics to the adult population, the FDA Real Cost Campaign prevented 654,477 adult smokers from switching to far less harmful, even life-saving, e-cigarettes.  The 95% confidence interval is 144,770 and 1,164,098.

I don’t believe the FDA ought to be evaluating its own campaign based on a secret dataset.  Between 2023 and 2024, teen vaping declined, so it’s easy for the FDA staff to claim that a concurrent FDA campaign was responsible.  Even worse, these FDA employees attest that they have “no financial disclosures” and that “The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Food and Drug Administration.”  You gotta be kidding me.   

 

Termination of Tobacco Harm Reduction Continuing Medical Education by the Accreditation Council

 

The full scope of tobacco use and related risks to health are misunderstood by all health professionals.  Deficits in health professionals’ knowledge have been documented by recent studies (1,2,3). 

Throughout 2024 there were three separate efforts to implement continuing medical education (CME) programs to address these information deficits.  Unfortunately, tobacco prohibitionists weaponized CME accreditation to terminate all of them. 

Incident 1

The first termination was successful. It occurred in April and involved Medscape, which describes itself as “the leading online global destination for physicians and healthcare professionals worldwide.” Medscape had invited me to serve as faculty in a series of short CME programs on THR (4).  Medscape clearly disclosed that the series was sponsored by Philip Morris International, but our programs were firewalled; faculty were not in contact with or influenced by the sponsor.

Topics included, among others, an examination of nicotine, and the differential risks of combusted versus smoke-free tobacco/nicotine products.  Following publication, anti-tobacco activists threatened in British Medical Journal articles (5,6) to initiate “a rapid global boycott by healthcare professionals disgusted by [Medscape’s] behaviour.”  Medscape abruptly cancelled the programs and permanently removed them from Medscape’s website, with little communication with the faculty (7).  Dr. Sally Satel, another faculty member in the program, also described the incident (8).

At the time, I was confused by Medscape’s seemingly inexplicable cancellation of our program, but in light of future developments, it is now clear that Medscape’s actions were in response to an ACCME complaint that is considered existential by CME providers.

Incident 2

On October 1, Yolanda Richardson, President and CEO of the Campaign for Tobacco-Free Kids; Joanna Cohen, Director of the Institute for Global Tobacco Control at Johns Hopkins University; and Phil Chamberlain, Deputy Director of the University of Bath, UK Tobacco Control Research Group, sent a letter to the ACCME president and CEO (9).  They complained that a THR CME program was being developed by the Physicians Research Institute with support from Global Action to End Smoking (GAES) (emphasis added).  They recommended “that ACCME institute an accreditation policy that specifically excludes the tobacco industry and any entities it funds.” 

Incident 3, University of Louisville (UofL)

(View the course here: https://bit.ly/3Ww7MF5)

In May 2024 I designed and was the course director and sole presenter of a 5-hour CME course to educate health professionals, primarily physicians, nurses, dentists and pharmacists, about less hazardous products that deliver nicotine/tobacco satisfaction and deliver a small fraction of the health risks of smoking. 

This course did not promote any medical interventions.  Rather, it educated health professionals so that they are in a better position to offer lifestyle options, especially to inveterate smokers unable or unwilling to quit nicotine/tobacco entirely.

On October 21, 2024 the UofL School of Medicine launched the course. 

On October 26 a complaint about the course was filed with the Accreditation Council for Continuing Medical Education (ACCME), which immediately informed Staci Saner, Ed.D., M.Ed., Assistant Dean, Continuing and Professional Education.  She immediately cancelled the course.

In a “Notice of Inquiry” dated October 29 (10), the ACCME described the complaint in three parts (my comments added).  One month later (November 22), the ACCME confirmed to UofL that this text comprised the “complete” complaint. 

“An accredited institution – the University of Louisville – is now promoting a CME-eligible course taught by Brad Rodu, on “tobacco harm reduction” - https://louisville.edu/medicine/cme/credits/tobacco-harm-reduction

This was a description of the course. 

Rodu is a well-known proponent of the tobacco industry’s scheme to promote its new, addictive products. He also has a history of being funded by the tobacco industry: https://www.tobaccotactics.org/article/brad-rodu/

This was an ad hominem attack.  I have conducted and published research on THR for 30 years.  THR is not an industry “scheme.”  My “history of being funded by the tobacco industry” has been a matter of public record since 1999.  It is also known to UofL officials, because UofL was the sole recipient and administrator of those grants from 2005 to 2018.  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 journals, other relevant organizations, and the ACCME.  I have no personal or other professional conflict of interest. 

…more information on Rodu, as well as how tobacco companies are co-opting public health harm reduction messages even as they continue to fight furiously against policies and regulations that are proven to decrease smoking rates and therefore prevent death and disease from tobacco use.

(see: https://www.hsph.harvard.edu/news/hsph-in-the-news/opinion-tobacco-industrys-harm-reduction-pledges-ring-false/  and https://thehill.com/opinion/healthcare/4524685-big-tobacco-is-trying-to-hide-its-greed-behind-harm-reduction/ )” 

While this passage started with “more information on Rodu,” the two cited links do not mention my name.

In summary, the complaint was false, vacuous and without merit.  It is important to emphasize that the UofL CME office later documented that during the 5 days the course was online, no participant registered and/or completed any segment.

On November 20 Dr. Saner submitted to the ACCME a preliminary response to the complaint (11).  I provided information to her and other UofL officials, and I received a copy of that response.  However, that is the last information I received from UofL officials until January 9, 2025.  On that date I received additional correspondence from Dr. Saner, which I use to continue this narrative.

In addition to the complaint text, the October 29 Notice of Inquiry stated “Based on a preliminary review of this offering on the University of Louisville School of Medicine’s website and on a complaint submitted by a third party, ACCME is concerned that the content of these activities may not have met the expectations for balance and bias outlined in Standard 1.”

In a letter dated November 22 (12), the ACCME provided more information about “which components or aspects of Standard 1 may not have been met: ACCME’s expectations for content validity are outlined in Standard 1, elements 1 and 2, which require accredited education to be evidence-based and balanced. Preliminary review of the material presented in this course does not demonstrate a balance between the various approaches to supporting smoking cessation, including nicotine replacement therapy, prescription medications, behavioral support, harm reduction strategies, and public policy and environmental supports. The material appears to selectively emphasize one perspective on the value of vaping as a harm reduction strategy, and does not present the range of risks, uncertainties and policy variability that exist for this component of approach to smoking cessation.” (my emphasis)

On December 5 Dr. Saner submitted to the ACCME what appears to be a final response to the Notice of Inquiry (13).  The text in that document refers to unspecified discussions, and it states that “the University agrees with this concern [about Standard 1].”  On December 11, ACCME issued a formal Notice of Noncompliance to UofL (14), which included that UofL had agreed, and would be forced to take the extensive remedial actions.   

 

ACCME Standard 1

Below I list all four elements of Standard 1 (15), even though the ACCME statement only referred to “elements 1 and 2.”  Following are my responses to all four elements of the standard.

1. All recommendations for patient care in accredited continuing education must be based on current science, evidence, and clinical reasoning, while giving a fair and balanced view of diagnostic and therapeutic options.

This element specifies that “fair and balanced” applies to “diagnostic and therapeutic options.”  My course does not discuss patient care, diagnosis or therapy.   The landing page for my course specifies that it “does not promote any medical intervention.  Rather, it educates health professionals so that they are in a better position to offer lifestyle options, especially to smokers unable or unwilling to quit nicotine/tobacco entirely.”  My course is entirely grounded in “current science, evidence, and clinical reasoning.”

 

2. All scientific research referred to, reported, or used in accredited education in support or justification of a patient care recommendation must conform to the generally accepted standards of experimental design, data collection, analysis, and interpretation.

All scientific research referred to, reported, or used in my course conforms to the generally accepted standards of experimental design, data collection, analysis, and interpretation.

3. Although accredited continuing education is an appropriate place to discuss, debate, and explore new and evolving topics, these areas need to be clearly identified as such within the program and individual presentations. It is the responsibility of accredited providers to facilitate engagement with these topics without advocating for, or promoting, practices that are not, or not yet, adequately based on current science, evidence, and clinical reasoning.

My course is entirely grounded in “current science, evidence, and clinical reasoning.”

4. Organizations cannot be accredited if they advocate for unscientific approaches to diagnosis or therapy, or if their education promotes recommendations, treatment, or manners of practicing healthcare that are determined to have risks or dangers that outweigh the benefits or are known to be ineffective in the treatment of patients.

My course does not “advocate for unscientific approaches… that are determined to have risks or dangers that outweigh the benefits or are known to be ineffective in the treatment of patients.”  Cigarette smoking kills 480,000 Americans every year.  The strategy, and the products I discuss in my course, are associated with, at most, only 5% or less of the hazard of cigarette smoking, according to the British Royal College of Physicians (16). 

The language in the ACCME statement also misinterprets my course.  The subject of the entire course is tobacco harm reduction, NOT smoking cessation, nicotine replacement therapy, prescription medications or behavioral support.  It was not necessary to include these subjects in my course, because tobacco harm reduction and smoking cessation are complimentary, not competing, strategies.  Both can simultaneously exist and succeed, with the goal of eliminating the 480,000 smoking-attributable deaths annually in the U.S.  I believe the ACCME’s position is unjustified, and other topics are not subjected to this criterion.  For example, a course focused on angioplasty and coronary stents for coronary artery disease would not be expected to provide expert education on coronary artery bypass grants.  The ACCME accredits numerous lifestyle medicine courses, and it is clear from the program details that ACCME has not interpreted Standard 1 similarly (17, examples supplied on request).

The ACCME’s inclusion of “harm reduction strategies” in the statement is incomprehensible, because that is the explicit subject of the course.  Similarly, “environmental supports” is obtuse and unclear.

I discuss differences in “public policy” positions on tobacco harm reduction in the course.

“…does not present the range of risks, uncertainties and policy variability that exist for this component of approach to smoking cessation.” 

This is untrue for various reasons.  First, in the segment entitled “Risks of E-Cigarettes and Heat-Not-Burn Tobacco Explained,” I discuss numerous studies associating e-cigarettes with myocardial infarction, stroke, COPD, emphysema, chronic bronchitis, and pregnancy complications, and I also discuss vaping and smoking among teens.  And I provide source links to all of these studies.

In the segment entitled “Risks of Smokeless Tobacco and Cigar Smoking Explained,” I discuss numerous studies associating smokeless tobacco with oral and other cancers, stroke, myocardial infarction, hypertension, pregnancy complications, and all-cause mortality in Sweden and the U.S.  I also discuss risks of cigar smoking with emphasis on a published study by FDA officials.

Once again, the ACCME labels tobacco harm reduction as “smoking cessation,” which is inaccurate.

 

Conclusions

The ACCME action was initiated by an ad hominem complaint about me that was false, vacuous and without merit.  The complaint did not mention any topic in AACME Standard 1.  The UofL CME office has no record of completion by anyone of even one of the five segments of my course.

On October 29, ACCME issued a “Notice of Inquiry stating “Based on a preliminary review of this offering…” ACCME was “concerned that the content of these activities may not have met the expectations for balance and bi as outlined in Standard 1.”

By December 11, 2024, the ACCME had escalated its claim to a “Notice of Noncompliance.” In this letter ACCME stated that UofL had agreed, and would be forced to take the following extensive actions: (a) Compile a list of the faculty, planners, reviewers involved in the planning and delivery of the activity. If any learners completed this activity (we understand they did not) then compile a list of these learners too. (b) Review the attached draft template for communicating with your faculty and planners (and any learners) and compose both the communication and reference list. (c) Before sending this communication to the activity’s learners, faculty, and planners, please return a copy of your intended communication for ACCME’s approval via email to complaints@accme.org. (d) Once this communication has been approved by the ACCME, and the corrective information has been distributed to all learners, faculty, and planners, you will be required to return a final report by January 30th 2025. (e) Confirm the distribution of the communication. (f) Provide a copy of the communication that was sent. (g) Provide an update related to newly established quality control processes.

In the December 11 letter, ACCME explicitly threatened the UofL CME program, “we would hope to close the inquiry without a change in status of your accreditation. Please be aware that information related to this inquiry will be included in materials reviewed at the time of your organization’s next application for continued accreditation.”

I was not aware of these actions until January 9.  It is clear that UofL and the ACCME closed the matter one month earlier.

In summary, the cancellation of my CME course on tobacco harm reduction was precipitated by a false, vacuous and meritless ad hominem complaint.  Subsequently, the ACCME served as prosecutor, judge and jury with respect to faulted interpretation of one of its standards that was not mentioned in the original complaint.  In addition to cancelling my course, the ACCME imposed burdensome sanctions on UofL’s entire CME program.  It is crystal clear to me that this weaponization of CME accreditation also resulted in Medscape’s actions detailed earlier.

References

1. Delnevo CD, Jeong M, Teotia A, et al. Communication Between US Physicians and Patients Regarding Electronic Cigarette Use. JAMA Netw Open. 2022;5(4):e226692. doi:10.1001/jamanetworkopen.2022.6692 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2791164   

2. Bover Manderski MT, Steinberg MB, Wackowski OA, Singh B, Young WJ, Delnevo CD. Persistent Misperceptions about Nicotine among US Physicians: Results from a Randomized Survey Experiment. Int J Environ Res Public Health. 2021 Jul 21;18(14):7713. doi: 10.3390/ijerph18147713. PMID: 34300168; PMCID: PMC8306881.  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8306881/   

3. Steinberg, M.B., Bover Manderski, M.T., Wackowski, O.A. et al. Nicotine Risk Misperception Among US Physicians. J GEN INTERN MED 36, 3888–3890 (2021). https://doi.org/10.1007/s11606-020-06172-8  https://link.springer.com/article/10.1007/s11606-020-06172-8    

4. Rodu B.  Medscape on Tobacco Harm Reduction: Part 1 – Nicotine.  March 17, 2024. https://rodutobaccotruth.blogspot.com/2024/03/medscape-on-tobacco-harm-reduction-part.html

5. Boytchev H.  Exclusive: Outcry as Philip Morris International funds smoking cessation courses on Medscape. BMJ 2024;385:q830 http://dx.doi.org/10.1136/bmj.q830 . April 9, 2024.

6. Boytchev H. Medscape caves in on courses funded by tobacco giant Philip Morris, while medics fear global push into medical education. BMJ 2024;385:q948 http://dx.doi.org/10.1136/bmj.q948 . April 26, 2024.

7. Rodu B.  What Medscape Subscribers Really Thought About Its Tobacco Harm Reduction Programs.  May 7, 2024  https://rodutobaccotruth.blogspot.com/2024/05/what-medscape-subscribers-really.html

8. Satel S.  Medscape Gets Smoked: Science should be judged on its merits, not on its funders.  City Journal. May 2, 2024.  https://www.city-journal.org/article/medscape-gets-smoked

9. Richardson Y, Cohen J, Chamberlain P, et al.  Letter to ACCME president regarding continuing medical education courses. October 1, 2024. https://louisville.box.com/s/ulch8xs4ixhng0rz9esrpgw9qk36vkbl

10. Richetti A.  Notice of Inquiry from ACCME. October 29, 2024. https://louisville.box.com/s/ba3b1t5pd44gngkayj83t6mgg21yullm

11. Saner S. Preliminary Response of University of Louisville to Notice of Inquiry. November 20, 2024.  https://louisville.box.com/s/ef6c02qu8q98k1j4n998owglcskjcihg

12. Richetti DA.  ACCME Response to Recent Communication.  November 22, 2024.  https://louisville.box.com/s/rcklo4d8h1ty93wblf8aftg4p3lk0skb

13. Saner S. Response of University of Louisville to Notice of Inquiry. December 5, 2024.  https://louisville.box.com/s/vyfq6kdo8ppcgezlwt0401kqcxnsce0l

14. Richetti DA.  ACCME Notice of Noncompliance.  December 11, 2024. https://louisville.box.com/s/8c2xbb4ncem5weczehac34u5s1glm7bj

15. ACCME. Standards for Integrity and Independence in Accredited Continuing Education. https://accme.org/rules/standards/

16. Royal College of Physicians. Nicotine without smoke: Tobacco harm reduction. London:

RCP, 2016. https://www.rcp.ac.uk/media/xcfal4ed/nicotine-without-smoke_0.pdf

17. Rodu B. Examples of Lifestyle Medicine Courses Accredited by ACCME. https://louisville.box.com/s/p81xp9zykm8lfwnb6bc38u6792ibr65p