Abstract

Clinical Practice Guidelines (CPGs) play significant roles in most medical fields. However, little is known about the extent of financial Conflicts of Interest (FCOIs) related to pharmaceutical companies (Pharma) selling dermatology prescription products and dermatology CPG authors in Japan. The aims of this study were to elucidate the characteristics and distribution of payments from Pharma to dermatology CPG authors in Japan, and to evaluate the extent of transparency and accuracy in their FCOI disclosures. We analyzed the records of 296 authors from 32 dermatology CPGs published by the Japanese Dermatological Association from the beginning of 2015 to the end of 2018. Using the payment data reported by 79 Pharma between 2016-2017 in Japan, we investigated the characteristics of the CPG authors and the payments from the Pharma to them. Furthermore, we evaluated the transparency and accuracy of the FCOI disclosures of the individual CPG authors. Of the 296 CPGs authors, 269 authors (90.6%) received at least one payment from the Pharma. The total monetary value of payments for the 2-year period was $7,128,762. The median and mean monetary value of payments from the Pharma reporting were $10,281 (interquartile range $2,796 -$34,962) and $26,600 (standard deviation $40,950) for the two years combined. Of the 26 CPG authors who disclosed FCOIs due to the monies received from Pharma, only the atopic dermatitis CPG authors and the acne vulgaris CPG authors published their potential FCOIs. In Japan, most dermatology CPG authors received financial payments from Pharma. The transparency of the CPGs, as reported by the CPG authors, was inadequate, and a more rigorous framework of reporting and monitoring FCOI disclosure is required to improve the accuracy and transparency with relation to possible Conflicts of Interest.

Highlights

  • There is increasing global attention on transparency with respect to the financial relationships between the pharmaceutical companies (Pharma) and healthcare professionals, with increasing concern about corrupt or unethical behavior

  • Using the payment data reported by 79 Pharma between 2016–2017 in Japan, we investigated the characteristics of the Clinical Practice Guidelines (CPGs) authors and the payments from the Pharma to them

  • In the analysis of 296 dermatology CPG authors in Japan, we revealed that 90.6% were reported by Pharma to have received at least one payment

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Summary

Introduction

There is increasing global attention on transparency with respect to the financial relationships between the pharmaceutical companies (Pharma) and healthcare professionals, with increasing concern about corrupt or unethical behavior. In Japan, the Japan Pharmaceutical Manufacturers Association (JPMA) developed a transparency guideline in the year 2011, with all member companies from 2013 onwards required to voluntarily publish all payments made to physicians, including for lecturing, writing and consultancy work, itemizing the value of payments along with individuals’ names and affiliations [4]. Among various medical fields in Japan, dermatology attracts one of the largest amounts of payment from the Pharma. Our previous research elucidated that Executive Board members of the Japanese Dermatological Association (JDA) received the second highest payments in the median values among those representing 18 basic medical fields in Japan [5]. The plausible explanations of this is a large market size (JPY 203 billion (US$186 million) in 2016) and development of novel and expensive biologic therapies over the last decade, such as ustekinumab (STELARA, approval year 2011), adalimumab (HUMIRA, approval year 2016), secukinumab (COSENTYX, approval year 2014) and brodalumab (LUMICEF, approval year 2016), as well as novel ointments

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