Posted on behalf of Ichiko Murai.
The credibility of Japan’s clinical research system has come under fire as investigations report manipulation of data and conflict of interest involving the pharmaceutical company Novartis. Six published papers have been retracted, but Novartis has denied any wrongdoing. The country’s health minister has now started its own investigation, which is due to release its findings at the end of September.
In question are five large-scale, post-marketing clinical studies on valsartan, a popular hypertension drug by the Basel, Switzerland-based pharma company. The Kyoto Prefectural University of Medicine, the Jikei University School of Medicine in Tokyo, Chiba University, the Shiga University of Medical Science in Otsu and Nagoya University respectively launched these studies between 2001 and 2004. After a few years of follow-up research, they published papers suggesting additional benefits of the drug — such as the prevention of other cardiovascular events — in addition to lowering blood pressure.