Japan confirms Novartis clinical trial data fabrication

Japan’s ministry of health has concluded that studies based on clinical trials for Novartis’s blood pressure drug Diovan contain manipulated data. It is now investigating whether the company has broken Japanese law by citing these studies to promote the product.

Diovan was approved for use in Japan in 2000, but recently two universities who hosted and analysed trials for Novartis – the Kyoto Prefectural University of Medicine and Jikei University School of Medicine – reported finding evidence of data fabrication. In August, the ministry of health launched an investigation, which has led to the retraction of several papers relating to Diovan’s ability to prevent angina and stroke. Some hospitals have stopped offering the drug, and investigations are now underway at three other universities that hosted Diovan clinical trials.

It is not yet clear who is responsible. As the investigation continues, officials at both Novartis HQ in Switzerland and Novartis Pharma KK, the Japanese subsidiary, have pledged their cooperation.