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.
- 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.”
- 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.
- 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.”
- 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
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OA, Singh B, Young WJ, Delnevo CD. Persistent Misperceptions about Nicotine
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34300168; PMCID: PMC8306881. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8306881/
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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
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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.
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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
