Under control. a Japanese inquiry scrutinizes the potential involvement of Novartis handle clinical trial data on one of its drugs.
Novartis
A commission of inquiry under the Japanese Ministry of Health has confirmed that the data in scientific papers resulting from clinical trials of the blockbuster hypertension drug Novartis Diovan have been handled, several media reported today. In its interim report, the committee also called for further investigation to determine whether the use of Novartis data to promote drugs constitutes false advertising that is prohibited by pharmaceutical laws of Japan, according to NHK, the broadcaster quasi- national.
The Ministry of Health launched the investigation in August after Kyoto Prefectural University of Medicine, Kyoto, and the medical school of the Jikei University in Tokyo, reported finding evidence of manufacturing data in the documents reporting the results of clinical trials of Diovan, known generically as valsartan, driving after receiving marketing approval in Japan in 00 to control hypertension. These clinical trials have sought to investigate whether the drug has also helped to prevent angina and stroke. Both surveys found that a former employee Novartis helped the research teams from both universities with data analysis, although the link that person to the company was not disclosed in the newspapers. The investigations led to the retraction of several records of testing. The senior researcher at the Kyoto school has resigned; Chief of Jikei team was disciplined. Three other universities that hosted Diovan trials ongoing investigations.
As in previous probes, the panel of the Ministry of Health could not conclude bears ultimate responsibility for making data. Novartis officials, based in Basel, Switzerland, Novartis Pharma KK, the Japanese subsidiary, apologized and promised their cooperation in the investigation continues.
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