Impact of pharmaceutical industry involvement in the external review of clinical practice guidelines-A case study.

Abstract

RATIONALE AND AIM\nExternal review is important when developing clinical practice guidelines. Involving pharmaceutical companies may influence guideline recommendations in their favour and is therefore controversial. Our study aimed to measure stakeholder participation in the external review of the 2016 European acne guideline and assess the extent to which comments submitted by pharmaceutical companies suggested changes favouring their own products.\n\n\nMETHODS\nRetrospective, partially blinded case study using qualitative analysis of comments submitted during external review.\n\n\nRESULTS\nFour stakeholder groups participated in the review: pharmaceutical company representatives (five out of five invited), professional association members (2/222), journal reviewers (n\xa0=\xa02), and visitors to the project website (n\xa0=\xa01). Of 78 comments submitted, 48 were from company representatives, 24 from journal reviewers, and six from others. Each comment suggested one change to the guideline. Of the comments submitted by companies, 41.7% related to writing or formatting, 16.7% to presentation of results, 12.5% to background information for main recommendations, and 12.5% to the strength of treatment recommendation . In 54.2% (26/48) of these comments, a change was suggested that put the companies own products in a more positive light. Five of these changes were implemented by the guideline authors in the way suggested by the company representatives.\n\n\nCONCLUSION\nParticipation of professional societies, patients, and the general public in the external review of the 2016 European acne guideline was unacceptably low. This is in concordance with reports of low participation of these groups in other European dermatology guidelines. While involving the pharmaceutical industry in the review substantially increased the number of comments received, many of these sought changes that would have put companies own products in a more favourable light. Our findings underscore the need to manage reviewer comments in a robust and transparent fashion. Solutions to encourage participation of all relevant stakeholders are needed.