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Sawano T, Ozaki A, Saito H, Shimada Y, Tanimoto T. Payments From Pharmaceutical Companies to Authors Involved in the Valsartan Scandal in Japan. JAMA Netw Open. 2019;2(5):e193817. doi:10.1001/jamanetworkopen.2019.3817
What is the extent of payments from pharmaceutical companies to authors who wrote the 5 retracted articles on the valsartan clinical trials after the revelation of the scandal in 2013?
A retrospective cross-sectional analysis using pharmaceutical companies’ data in 2016 showed that 29 of 50 authors (58%) associated with the 5 articles received payments from pharmaceutical companies, with 10% of authors receiving payment in the Japanese yen of more than ¥5 million. The total payment to the corresponding author of these 5 articles accounted for 43.4% of the total payments.
Study finding suggest that clinical trial practitioners received large payments from the pharmaceutical industry even after the unprecedented scandal.
Financial relationships between pharmaceutical companies and physicians can bias the conduct, findings, and reporting of clinical trials. In Japan, the valsartan scandal was a significant event: all 5 key articles on the valsartan clinical trials were retracted after the revelation of data falsification. Consequently, the Japan Pharmaceutical Manufacturers Association issued transparency guidelines, and pharmaceutical payments have been publicly disclosed since 2013. However, the distribution of payments from pharmaceutical companies among authors involved in the valsartan scandal after its revelation has not been studied to date.
To identify the characteristics and distribution of payments from pharmaceutical companies to researchers involved in the valsartan scandal in Japan by using a comprehensive payment database.
Design, Setting, and Participants
This retrospective cross-sectional study, conducted from January 1, 2016, through September 30, 2017, used information on payments from 78 pharmaceutical companies to 50 authors of 5 articles retracted after the valsartan scandal: the Kyoto Heart Study, Jikei Heart Study, SMART (Shiga Microalbuminuria Reduction Trial), VART (Valsartan Amlodipine Randomized Trial), and Nagoya Heart Study. Payments from companies to physicians were analyzed during the period from January 1, 2016, to September 30, 2017.
Main Outcomes and Measures
The main outcomes were the amount and proportion of payments made by pharmaceutical companies to authors, and the forms of these payments.
Of 50 eligible authors, 29 (58%) received payments from pharmaceutical companies in 2016. The payments in the Japanese yen totaled ¥64 188 393 (US $564 858) and the mean (SD) payment was more than ¥1 283 768 (¥2 999 919) (US $11 297 [$26 399]). Five authors (10%) received more than ¥5 million (US $44 000) and 3 authors (6%) received more than ¥10 million (US $88 000). The total payments to the corresponding author of each article was ¥27 826 374 (US $244 872), accounting for 43.4% of the total payments. Regarding forms of the payments, lecture fees accounted for 81.3% of the total payment (¥54 182 972 [US $476 810]).
Conclusions and Relevance
Many authors involved in the valsartan scandal received payments from the pharmaceutical industry. Although whether such payments to these authors have decreased since the scandal is unclear, the findings appear to demonstrate that their financial relationships with the industry are still prominent. The findings of the study appear to support the need to encourage more transparency in such relationships because misconduct can occur within unclear relationships.
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