Published on in Vol 5, No 2 (2022): Apr-Jun

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/37749, first published .
Pharmaceutical Payments to Authors of Dermatology Guidelines After Publication

Pharmaceutical Payments to Authors of Dermatology Guidelines After Publication

Pharmaceutical Payments to Authors of Dermatology Guidelines After Publication

Research Letter

1Department of Dermatology, University of Colorado Anschutz Medical Campus, Aurora, CO, United States

2Arizona College of Osteopathic Medicine, Glendale, AZ, United States

3Department of Dermatology, Henry Ford Hospital, Detroit, MI, United States

4Santa Clara University, Santa Clara, CA, United States

5University of Missouri School of Medicine, Columbia, MO, United States

6Dermatology Service, Rocky Mountain Regional Veterans Affairs Medical Center, Aurora, CO, United States

*these authors contributed equally

Corresponding Author:

Robert Dellavalle, MD, MSPH, PhD

Department of Dermatology

University of Colorado Anschutz Medical Campus

1700 N Wheeling St

Aurora, CO, 80045

United States

Phone: 1 7208480500

Email: robert.dellavalle@cuanschutz.edu



Clinical practice guidelines (CPGs) play increasingly vital and influential roles in clinical decision-making, optimization of patient care, and establishment and assessment care quality standards, and can affect insurance coverage. Oftentimes, CPG author expertise is sought by insurance and pharmaceutical companies, creating industry-physician relationships that may influence physicians’ professional decisions. This is known as a conflict of interest (COI). Previous studies [1,2] provide strategies for reducing COI impact on guideline development (eg, restricting voting on final recommendations by committee members with COIs [1], requiring conflict-free periods prior to participation in guideline development [2]). In a June 2020 statement, the American Academy of Dermatology (AAD) announced revisions to its guideline development process, specifying that at least 51% of those authoring guidelines be nonconflicted (ie, no relevant financial COIs) and requiring nonconflicted authors to remain so for the entire guideline development process (ie, no new relevant industry relationships initiated during development) [3]. CPG development ends when the draft guideline is approved by the AAD’s Board of Directors and submitted for publication [4]. The AAD requires disclosure of financial interests occurring within the 2-year period prior to CPG authorship [5]. Although a prior study[6] demonstrated that former Food and Drug Administration committee members frequently received payments from the industry after the approval of dermatologic drugs, to our knowledge, there exists no similar exploration of industry payments to authors of recently published AAD guidelines.

Post hoc general industry payments to AAD guideline authors in the period shortly following guideline publication (defined as publication year and 1 subsequent year) were analyzed. We reviewed all current AAD CPGs, including acne vulgaris, atopic dermatitis, keratinocyte carcinoma (basal cell carcinoma and squamous cell carcinoma, same guideline authors), melanoma, psoriasis, and surgery, with publication dates spanning from 2013 to 2018. General payments made by companies to each CPG author were extracted and aggregated from publicly available data in the Centers for Medicare and Medicaid Services Open Payments database [7]. The psoriasis guideline was excluded from further analysis because, unlike the other guidelines, it was published after the recent changes to the AAD’s COI policy for guideline authors, and Open Payments data was only available through 2020. The Food and Drug Administration Orange [8] and Purple [9] Book databases were searched to identify companies (and subsidiaries, according to US Securities and Exchange Commission filings) that were manufacturers of CPG drugs.

Of the 6 dermatology CPGs (Table 1), total payments to CPG authors by pharmaceutical companies manufacturing CPG-recommended drugs ranged from $46,554 (melanoma) to $1,374,780 (acne).

Of 99 unique CPG authors, 56 (57%) received at least one payment from a company responsible for a CPG-recommended drug (range 39%-74% across guidelines) (Table 2). A total of 22 (22%) received ≥$10,000 and 10 (10%) received ≥$50,000.

Overall, AAD CPG authors received substantial industry payments from companies with financial interests in the guideline recommendations, corroborating previous studies [10]. Industry payments occurring in the early postpublication period were received by more than 51% of the authors of CPGs on atopic dermatitis, acne, and surgery. Efforts to improve the transparency of author disclosures and minimize commercial bias are encouraged, and future studies should assess the impact of the recently implemented changes to the AAD’s guideline development.

Table 1. Pharmaceutical paymentsa to American Academy of Dermatology (AAD) clinical practice guideline (CPG) authors.
RankAtopic dermatitis guideline drug companyPayments to authors ($)Acne vulgaris guideline drug companyPayments to authors ($)Local anesthesia for dermatologic surgery guideline drug companyPayments to authors ($)BCCb and SCCc guideline drug companyPayments to authors ($)Melanoma guideline drug companyPayments to authors ($)
1Medimetriks Pharmaceuticals223,630.70Galderma (and subsidiaries)453,849.76Teva (and subsidiaries)53,630.20Lilly (and subsidiaries)123,696.59Merck21,546.61
2Pfizer (and subsidiaries)170,815.50Abbvie (and subsidiaries)429,684.33Purdue Pharma12,837.50Novartis (and subsidiaries)73,842.97Bristol Myers Squibb (and subsidiaries)14,548.21
3Novartis (and subsidiaries)147,242.97Valeant Pharmaceuticals209,588.28Sun Pharma (and subsidiaries)9178.76Pfizer (and subsidiaries)16,490.66Novartis7271.78
4Celgene Corporation76,003.29Bayer110,725.18Genentech8394.02Pierre Fabre Pharmaceuticals6842.92Bausch (and subsidiaries)2238.43
5Valeant Pharmaceuticals47,953.71Pfizer (and subsidiaries)85,442.24Novartis (and subsidiaries)5495.04Bausch (and subsidiaries)4496.13Roche (and subsidiaries)949.61
6Galderma (and subsidiaries)35,197.51Sanofi (and subsidiaries)27,533.66Pfizer (and subsidiaries)2561.25Biofrontera540.67d
7Lilly (and subsidiaries)29,300.02Dr Reddy\'s Laboratories (and subsidiaries)19,922.14Bristol Myers Squibb (and subsidiaries)1185.94Smith & Nephew (and subsidiaries)325.56
8Abbvie (and subsidiaries)27,875.65Novartis (and subsidiaries)19,880.38Abbott Laboratories325.00Sun Pharma (and subsidiaries)231.67
9Sanofi-Aventis24,989.05Almirall (and subsidiaries)5565.86Bayer117.13Taro Pharmaceuticals108.78
10Merck (and subsidiaries)22,693.38Sun Pharma (and subsidiaries)4235.73Valeant Pharmaceuticals73.87Genentech61.92
11Astellas Pharma18,777.96Janssen (and subsidiaries)2783.54Merck45.71Almirall33.51
12Roche (and subsidiaries)17,618.10Taro2472.86Lilly35.58Amgen14.33
13Ranbaxy16,385.19Exeltis1750.00Promius Pharma19.14
14GlaxoSmithKline16,102.24Lilly650.40
15Aqua Pharmaceuticals13,812.70Merz (and subsidiaries)565.31
16Taro Pharmaceuticals10,010.42Lupin Pharmaceuticals49.66
17Bayer9000.00Biofrontera30.99
18Dr Reddy\'s Laboratories (and subsidiaries)6680.09Shire22.15
19Leo Pharma (and subsidiaries)5618.60Teva14.86
20Medimmune1844.42Arbor12.77
21Teva (and subsidiaries)1394.09
22UCB SA358.00
Total payments to authors923,303.591,374,780.1093,899.14226,685.7146,554.64

aGeneral payment data from Open Payments was totaled for each AAD CPG author in the year of CPG publication and the subsequent year. General payments include payments or other transfers of value that were not made in connection with a research agreement or research protocol. Company subsidiaries were determined according to recent US Securities and Exchange Commission filings.

bBCC: basal cell carcinoma.

cSCC: squamous cell carcinoma.

dN/A: not applicable.

Table 2. American Academy of Dermatology (AAD) clinical practice guideline (CPG) authors receiving paymentsa from pharmaceutical companies manufacturing CPG-recommended drugs.

Atopic dermatitisAcne vulgarisLocal anesthesia for dermatologic surgeryBCCb and SCCcMelanomaTotal unique guideline authors
Total payments to guideline authors ($)923,303.591,374,780.1093,899.14226,685.7146,554.642,665,223.18
Total guideline authors, n232214311699
Authors receiving payments, n (%)17 (74)14 (64)8 (57)12 (39)7 (44)56 (57)
Mean payment to authors receiving payments ($)54,311.9898,198.5811,737.3918,890.486650.6647,593.27
Median payment to authors receiving payments ($)9319.0223,475.751940.41256.342194.874939.40
Authors receiving payments ≥$10,000, n (%)7 (30)11 (50)1 (7)3 (10)1 (6)22 (22)
Authors receiving payments ≥$50,000, n (%)3 (13)5 (23)1 (7)1 (3)0 (0)10 (10)

aGeneral payment data from Open Payments was totaled for each AAD CPG author in the year of CPG publication and the subsequent year. General payments include payments or other transfers of value that were not made in connection with a research agreement or research protocol.

bBCC: basal cell carcinoma.

cSCC: squamous cell carcinoma.

Conflicts of Interest

RD is editor-in-chief of JMIR Dermatology, a joint coordinating editor for Cochrane Skin, a dermatology section editor for UpToDate, a social media editor for the Journal of the American Academy of Dermatology (JAAD), and a podcast editor for the Journal of Investigative Dermatology (JID). He is a coordinating editor representative on Cochrane Council. TES is an editorial board member at large for JMIR Dermatology.

RD receives editorial stipends (JAAD, JID), royalties (UpToDate), and expense reimbursement from Cochrane Skin. TES receives fellowship funding from Pfizer Inc.

  1. Sox HC. Conflict of Interest in Practice Guidelines Panels. JAMA 2017 May 02;317(17):1739-1740. [CrossRef] [Medline]
  2. Williams MJ, Kevat DAS, Loff B. Conflict of interest guidelines for clinical guidelines. Med J Aust 2011 Oct 17;195(8):442-445. [CrossRef] [Medline]
  3. Freeman EE, McMahon DE, Fitzgerald M, Robinson S, Frazer-Green L, Hariharan V, American Academy of Dermatology Ad Hoc Task Force on Modernizing Clinical Guidance. Modernizing clinical practice guidelines for the American Academy of Dermatology. J Am Acad Dermatol 2020 Jun;82(6):1487-1489 [FREE Full text] [CrossRef] [Medline]
  4. Guideline Development Process. American Academic of Dermatology Association.   URL: https://www.aad.org/member/clinical-quality/guidelines/development [accessed 2022-06-10]
  5. Disclosures. American Academic of Dermatology Association.   URL: https://disclosures.aad.org/ [accessed 2022-06-10]
  6. Kuschel SL, Ricotti CM, Dunnick CA, Hugh J, Dellavalle RP. Analysis of conflicts of interest in pharmaceutical payments made to Food and Drug Administration physician advisers after dermatologic drug approval. J Am Acad Dermatol 2019;81(6):1419-1420. [CrossRef]
  7. Search Open Payments. Open Payments.   URL: https://openpaymentsdata.cms.gov/ [accessed 2021-05-31]
  8. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Food and Drug Administration.   URL: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm [accessed 2021-01-07]
  9. Purple Book Database of Licensed Biological Products. Food and Drug Administration.   URL: https://purplebooksearch.fda.gov/ [accessed 2022-06-10]
  10. Checketts JX, Sims MT, Vassar M. Evaluating Industry Payments Among Dermatology Clinical Practice Guidelines Authors. JAMA Dermatol 2017 Dec 01;153(12):1229-1235 [FREE Full text] [CrossRef] [Medline]


AAD: American Academy of Dermatology
COI: conflict of interest
CPG: clinical practice guideline
JAAD: Journal of the American Academy of Dermatology
JID: Journal of Investigative Dermatology


Edited by R Alhusayen; submitted 04.03.22; peer-reviewed by J Solomon, A Finstad; comments to author 20.04.22; revised version received 27.05.22; accepted 06.06.22; published 20.06.22

Copyright

©Torunn E Sivesind, Mindy D Szeto, Jarett Anderson, Jalal Maghfour, Maya Matheny, Quan Nguyen Minh Le, Michael Kamara, Robert Dellavalle. Originally published in JMIR Dermatology (http://derma.jmir.org), 20.06.2022.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Dermatology Research, is properly cited. The complete bibliographic information, a link to the original publication on http://derma.jmir.org, as well as this copyright and license information must be included.