Under scrutiny. A Japanese investigative panel is probing Novartis’s potential involvement manipulating clinical trial data on one of its drugs.


Problems Mount for Novartis's Hypertension Drug in Japan

An investigative committee under Japan's ministry of health has confirmed that data in scientific papers resulting from clinical trials of Novartis's blockbuster hypertension drug Diovan were manipulated, several media outlets have reported today. In its interim report, the committee also called for further investigation to determine if Novartis's use of the data to promote the drug constitutes false advertising that is prohibited by Japan’s pharmaceutical laws, according to NHK, the quasi-national broadcaster.

The ministry of health launched its investigation in August after Kyoto Prefectural University of Medicine, in Kyoto, and Jikei University School of Medicine, in Tokyo, reported finding evidence of data fabrication in papers reporting the results of clinical trials of Diovan, known generically as valsartan, conducted after it received marketing approval in Japan in 2000 for controlling hypertension. Those clinical trials sought to study whether the drug also helped prevent angina and stroke. Both of the investigations found that a former Novartis employee helped the two universities’ research teams with data analysis, though that person's link to the company was not disclosed in the papers. The investigations led to the retraction of several papers related to the trials. The lead researcher at the Kyoto school resigned; the Jikei team leader was disciplined. Three other universities that hosted Diovan trials have ongoing investigations.

As in the previous probes, the health ministry panel could not conclude who bears ultimate responsibility for the data fabrication. Officials of Novartis, based in Basel, Switzerland, and Novartis Pharma KK, the Japanese subsidiary, have apologized and pledged their cooperation in the continuing investigation.