Financial relationships between pharmaceutical companies and physicians can bias the conduct, findings, and reporting of clinical trials.
1 This problem is well illustrated in the misconduct in Japanese clinical trials of valsartan (hereafter, the valsartan scandal), an angiotensin receptor blocker manufactured by Novartis.
2 With financial and personnel support from Novartis, 5 Japanese medical schools conducted the clinical trials of valsartan in the 2000s, namely, the Kyoto Heart Study (Kyoto Prefectural Medical University),
3 Jikei Heart Study (Jikei University of Medicine),
4 Shiga Microalbuminuria Reduction Trial (SMART) (Shiga University of Medical Science),
5 Valsartan Amlodipine Randomized Trial (VART) (Chiba University),
6 and Nagoya Heart Study (Nagoya University)
7 (Table 1). Their findings were published in international medical journals: the Jikei Heart Study was published in
The Lancet in 2007,
4 and the Kyoto Heart Study was published in
European Heart Journal in 2009.
3 However, these 5 primary and 3 associated studies, including a subanalysis of the Kyoto Heart Study, were retracted after the revelation of the originally unmentioned involvement of a Novartis employee (statistician) in these studies, and numerous instances of data fabrication.