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
2. Bover Manderski MT, Steinberg MB, Wackowski
OA, Singh B, Young WJ, Delnevo CD. Persistent Misperceptions about Nicotine
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https://link.springer.com/article/10.1007/s11606-020-06172-8
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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.
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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
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8. Satel S.
Medscape Gets Smoked: Science should be judged on its merits, not on its
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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
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12. Richetti DA. ACCME Response to Recent Communication. November 22, 2024. https://louisville.box.com/s/rcklo4d8h1ty93wblf8aftg4p3lk0skb
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