Opinion
EDITORIAL
Industry Influence in Dermatology Clinical Practice
Guideline Development
Kenneth A. Katz, MD, MSc, MSCE
In his farewell address to the nation, in 1961, President Dwight
D. Eisenhower warned about the rising influence of the mili-
tary establishment and the arms industry. The potential for
the disastrous rise of misplaced power exists, the President
said, referring to the military-industrial complex, and will
persist.1
Forty years after that speech, as I began my dermatology
residency, another complex with potential for misplaced power
was ascending: the dermatology-industrial complex. Topical
calcineurin inhibitors for atopic dermatitis and biologic drugs
for psoriasis had just arrived, and marketing efforts were
pardon the punon steroids.
Industry was my partner, I was taught, as I learned to be a
dermatologist. Indeed, I learned by reading textbooks and jour-
nals gifted to me by pharmaceutical companies and their rep-
resentatives; attended lectures by drug company reps and in-
dustry-paid thought leaders
at industry-sponsored events;
Related article provided patients with pre-
scription and nonprescrip-
tion drug samples from closets stocked by drug company reps,
who also offered freebies for personal use (You can have a life-
time supply, one would promise, referring to his companys
moisturizers. You just cant have it all at once!); and went to
the American Academy of Dermatologys (AAD) annual meet-
ingitself underwritten in large part by industry partners companies that paid an author (except food and beverage,
courtesy of pharmaceutical companies, which during the days
distributed not only free samples but also company-
monogrammed bags in which to carry them, and during the eve-
nings hosted lavish parties, with free booze and, occasionally,
a performance by a B-list celebrity (no offense, Pat Benatar;
thanks for rocking out during the AAD meeting in New Orleans
in 2002).
In the years since I completed residency, the pendulum
has in some ways swung in the other direction. I now decline
free lunches, swag, party invitations, and other goodies
offered by pharmaceutical companies. Many institutions
including Kaiser Permanente, where I workhave banned
prescription drug samples and drug companysponsored
lunches. More broadly, the Institute of Medicine has recom-
mended policies and procedures to mitigate conflicts of
interest (COIs) arising from physician-industry interactions
in medical research, education, and practice.2
What about industry influence in dermatology clinical
practice guidelines (CPGs)? Industry ties among CPG contribu-
tors have been reported,3 and a study by Checketts et al4 pub-
lished in this issue of JAMA Dermatology seeks to address that
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question for dermatology specifically. Its an important ques-
tion, because CPGs influence decision making by physicians,
patients, and insurers.5
Checketts et al4 conducted a cross-sectional study of fi-
nancial COIs (FCOIs) among authors of dermatology CPGs. The
study had several aims: (1) to identify dermatology CPGs pub-
lished in the United States from 2013 to 2016; (2) to quantify
amounts and types of pharmaceutical company payments, if
any, received by CPG authors, by querying the federal govern-
ments Open Payments database; (3) to assess whether pub-
lished CPGs adequately disclosed authors FCOI; (4) to deter-
mine whether authors of a CPG received payments from
companies that manufactured products relevant to that CPG;
and (5) to determine whether AAD adhered to its own admin-
istrative regulations (ARs) regarding identifying, managing, and
disclosing FCOI in CPG development.
Checketts et al4 identified and analyzed 3 CPGs for acne
vulgaris, 6 local anesthesia in office-based dermatologic
surgery,7 and atopic dermatitis (AD).8-11 The 4-part AD CPG was
counted as a single CPG. Among 49 CPG authors, according to
Checketts et al, 40 authors (82%) received at least 1 of various
payment types from 2013 to 2015, with 12 authors (24%) each
receiving more than $100 000. Among the 40 authors receiv-
ing payment, Checketts et al categorized 22 FCOI disclosures
(55%) as discrepant, defined as failing to include 1 or more
which was not included in the discrepancy analysis).
For each CPG, Checketts et al4 report at least 2 companies
with products relevant to the CPG that made payments to most
of that CPGs authors. According to the study, none of the CPGs
included fully accurate FCOI disclosures for authors who re-
ceived payments from companies making relevant products.
As for AAD adherence to its ARs for CPG development,12 Check-
etts et al report important gaps, including exceeding the al-
lowable percentage of authors with FCOI to serve on each CPG.
Three questions arise from the study by Checketts et al.
First, are the results valid? Its not clear, in many ways. Sev-
eral examples follow.
Time Frames
The study assessed payments made from the date of the ini-
tial literature search to the date of publication for each CPG.
On the front end, the study likely failed to capture payments
occurring during development of the literature search strat-
egy, underestimating FCOI among CPG authors. On the back
end, the study likely included payments made after CPG de-
velopment ended, but before CPG publication. The upshot is
(Reprinted) JAMA Dermatology Published online October 18, 2017 E1
 Opinion Editorial

that assessments of FCOIincluding discrepant FCOI
among authors, including chairs, might be inaccurate.
Relevance of a Manufacturers Products to a CPG
Study methods do not state criteria by which such determi-
nations were made. The assertion by Checketts et al4 that botu-
linum toxin was a focus area of the office based surgery guide-
lineit is clearly not a focus of the CPG, which covers use of
local anesthesia in office based surgeryraises questions about
the validity of those determinations.
AAD Adherence to ARs
[M]ore than 70% of authors received payments in all CPGs,
Checketts et al4 state, which is much higher than the allow-
able 51% stated in the Regulations. That misrepresents the ARs,
which cap the percentage of CPG work group members with
FCOI that is relevantnot simply any FCOIat 49% (not
51%).12 Given concerns about time frames and determination
of relevance of products to CPGs, it is not clear in fact that AAD
violated its ARs, at least in this regard.
Version of ARs
The version of the regulation13 cited by Checketts et al was out
of date when the acne and local anesthesia CPGs were pub-
lished. Both of those CPGs refer to AAD ARs revised in 2012
(with a subsequent revision since then12). Lack of attention to
that detaileven though the versions do not seem to differ sub-
stantiallyundermines confidence in the study.
Second question: Does it matter whether authors of derma-
tology CPGs have relevant FCOI? As Checketts et al4 acknowledge,
that question is one that the study did not address. The answer,
though, is likely yes. Just as FCOI likely influences physicians in
other roles,2,5 its a fair assumption that the same applies to writ-
ing CPGs. Even in the absence of clear evidence that FCOI resulted
in biased CPGs, avoiding such a perception should spur efforts
to manage FCOI as effectively as possible.5
That leads to the third question: What should be done?
Checketts et al4 urge AAD to increase transparency and en-
forcement of FCOI policies and procedures, and to decrease
the allowable percentage of CPG work group members with
FCOIs to 33% from 49%. Whether adopting those or other mea-
sures would improve CPGs is an open question, in light of the
dearth of research on how best to manage FCOI in CPG
development.3 Given the questions that Checketts et al raise,
however, AAD should itself audit its adherence to its ARs, re-
port the findings, and implement changes, if needed. The AAD
should also incorporate, as they emerge, evidence-based best
practices in CPG development.
We must take nothing for granted, President Eisen-
hower said, in encouraging Americans to guard against the in-
fluence of the military-industrial complex. The same goes for
our specialtys interactions with industry. The study by Check-
etts et al4 study serves as a reminder that physicians and other
stakeholders should continue to guard against the potential for
ties to industry, including among CPG authors, to inappropri-
ately influence the way we care for our patients.

ARTICLE INFORMATION
Author Affiliation: Kaiser Permanente, San
Francisco, California.
Corresponding Author: Kenneth A. Katz, MD, MSc,
MSCE, Kaiser Permanente, 1600 Owens St, Ninth
Floor, San Francisco, CA 94158 (kenneth.katz
@gmail.com).
Published Online: October 18, 2017.
doi:10.1001/jamadermatol.2017.4323
Conflict of Interest Disclosures: In the previous
year (but not currently), Dr Katz has owned stock in
Arrowhead Pharmaceuticals and Prevention Health
Labs. No other disclosures are reported.
REFERENCES
1. Eisenhower DD. Military-Industrial Complex
Speech. 1961. http://avalon.law.yale.edu/20th
_century/eisenhower001.asp. Accessed August 24,
2017.
2. Lo B, Field MJ. IOM (Institute of Medicine).
Conflict of Interest in Medical Research, Education,
and Practice. Washington, DC: National Academies
Press; 2009.
3. Mitchell AP, Basch EM, Dusetzina SB. Financial
relationships with industry among National
Comprehensive Cancer Network guideline authors.
JAMA Oncol. 2016;2(12):1628-1631.
4. Checketts JX, Sims MT, Vassar M. Evaluating
industry payments among dermatology clinical
practice guidelines authors [published online
October 18, 2017]. JAMA Dermatol. doi:10.1001
/jamadermatol.2017.3109
5. IOM (Institute of Medicine). Clinical Practice
Guidelines We Can Trust. Washington, DC: National
Academies Press; 2011.
6. Zaenglein AL, Pathy AL, Schlosser BJ, et al.
Guidelines of care for the management of acne
vulgaris. J Am Acad Dermatol. 2016;74(5):945-73.e33.
7. Kouba DJ, LoPiccolo MC, Alam M, et al.
Guidelines for the use of local anesthesia in
office-based dermatologic surgery. J Am Acad
Dermatol. 2016;74(6):1201-1219.
8. Eichenfield LF, Tom WL, Chamlin SL, et al.
Guidelines of care for the management of atopic
dermatitis: section 1, diagnosis and assessment of
atopic dermatitis. J Am Acad Dermatol. 2014;70(2):
338-351.
9. Eichenfield LF, Tom WL, Berger TG, et al.
Guidelines of care for the management of atopic
dermatitis: section 2, management and treatment
of atopic dermatitis with topical therapies. J Am
Acad Dermatol. 2014;71(1):116-132.
10. Sidbury R, Davis DM, Cohen DE, et al; American
Academy of Dermatology. Guidelines of care for the
management of atopic dermatitis: section 3,
management and treatment with phototherapy
and systemic agents. J Am Acad Dermatol. 2014;71
(2):327-349.
11. Sidbury R, Tom WL, Bergman JN, et al.
Guidelines of care for the management of atopic
dermatitis: section 4, prevention of disease flares
and use of adjunctive therapies and approaches.
J Am Acad Dermatol. 2014;71(6):1218-1233.
12. American Academy of Dermatology and AAD
Association. Administrative Regulations.
Evidence-Based Clinical Practice Guidelines.
Administrative Revision, May 1, 2014.
https://www.aad.org/Forms/Policies/Uploads/AR
/AR%20Evidence-Based%20Clinical%20Practice
%20%20Guidelines.pdf. Accessed August 24,
2017.
13. American Academy of Dermatology and AAD
Association. Administrative Regulations.
Evidence-Based Clinical Practice Guidelines.
Revised by Board of Directors, May 22, 2010.
https://www.aad.org/practicecenter/quality
/clinical-guidelines/guideline-development-process.
Accessed August 24, 2017.

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