Toroser Dikran, DeTora Lisa, Cairns Angela, Juneja Renu, Georgieva Anna, Weigel Al, Pepitone Kim
a 1 Amgen, Inc. - Global Medical Writing , Thousand Oaks, CA, USA.
Postgrad Med. 2015;127(7):752-7. doi: 10.1080/00325481.2015.1084211. Epub 2015 Aug 27.
To review guidance from professional medical associations to physicians on the Sunshine Act, with a focus on industry support for medical publications.
Using 'Sunshine Act' as a search term, we searched PubMed (dates February 2013 to November 2014) and the 'grey literature' using Google and Google Scholar. Online information was extracted from websites of pre-identified professional medical associations.
Some professional medical associations have published peer-reviewed recommendations, position statements or general advice on their websites and in journals around the Sunshine Act. Associations also provided broad online educational resources for physicians. There was universal agreement between peer-reviewed publications, including guidelines, for the need for full transparency and disclosure of industry support. Surveys by some professional associations showed variance in opinion on the forecasted impact of the Sunshine Act on physician-industry relationships. There was scarce information specifically related to reporting requirements for industry-supported medical publications.
There is a shortage of information for physicians from professional associations regarding the Sunshine Act and support for medical publications. Due to the lack of clear guidance regarding support for publications, there are presently varying interpretations of the Sunshine Act. The literature debates the potential impact of the Sunshine Act and expresses some concerns that physician-enabled innovation in drug development may be hindered.
回顾专业医学协会针对医生发布的有关《阳光法案》的指南,重点关注医药行业对医学出版物的资助。
以“阳光法案”作为检索词,检索了PubMed数据库(检索时间为2013年2月至2014年11月),并使用谷歌和谷歌学术检索了“灰色文献”。从预先确定的专业医学协会网站上提取在线信息。
一些专业医学协会在其网站及相关期刊上发表了经同行评议的关于《阳光法案》的建议、立场声明或一般性建议。这些协会还为医生提供了广泛的在线教育资源。包括指南在内的同行评议出版物普遍认同医药行业资助需要完全透明和公开披露。一些专业协会开展的调查显示,对于《阳光法案》对医生与医药行业关系的预期影响,各方观点存在差异。关于医药行业资助的医学出版物的报告要求,相关信息非常匮乏。
专业协会向医生提供的有关《阳光法案》及医学出版物资助方面的信息不足。由于缺乏关于出版物资助的明确指南,目前对《阳光法案》存在不同解读。文献对《阳光法案》的潜在影响展开了讨论,并表达了一些担忧,即医生推动的药物研发创新可能会受到阻碍。