Novartis Probes Researcher’s Employment Status

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Drug maker staff found to have joined research without identifying

OSAKA, May 24 — (KYODO) _ An employee of Pharma K.K. is found to have participated in clinical research using a major blood pressure treatment without identifying employment in research papers, with some papers having been retracted due to problems with data.

Norvatis Pharma, a Japanese unit of Swiss drug company Novartis AG, said that “nothing has been found so far that points to any intentional data manipulation.” Universities and academic societies that had conducted the research have launched investigations.

The drug in question is Diovan, generically called valsartan, a treatment for high blood pressure and a major product in Novartis Pharma’s lineup. It generated 108.3 billion yen in revenue in Japan from the drug.

A team including Hiroaki Matsubara, a former professor with the Kyoto Prefectural University of Medicine, published seven papers in academic journals between 2008 and 2012. Of them, six have been withdrawn. A journal cited “fatal problems with data” for its retraction of papers from late last year to this year.

The data concerned 3,000 Japanese patients with high blood pressure and showed Diovan works better than other blood pressure lowering drugs in reducing brain strokes and angina.

In a 2009 paper outlining the method of research, a then employee of Novartis Pharma is listed as one handling statistical analyses but identified as affiliated only with the Osaka City University where the person was serving as a lecturer. The paper said Norvatis Pharma “is not involved in data analyses.” The employee has retired from the company.

Matsubara’s office received a total of more than 100 million yen from Novartis Pharma between fiscal 2009 and 2012 in the name of donations to encourage studies. The use of the fund was not necessarily limited to the research in question.

The hospital affiliated with the university…Read more

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