【Medicine】Novartis research scrutinised in Japan:“extremely regrettable”Japanese health minister, Norihisa Tamura, said

swissinfo.ch July 12, 2013
The Basel-based pharmaceutical firm Novartis has admitted that there was an undisclosed conflict of interest in a study of one of its drugs carried out at a Japanese university, but says guidelines now in place are followed by all its employees.

An unnamed researcher, reported to be an adjunct lecturer at Osaka City University, had hidden the fact that he was an employee of the Japanese unit, Novartis Pharma K.K., when he was taking part in a study of the Novartis drug Valsartan, the Japanese health minister said on Friday, describing this as “extremely regrettable”.

The Kyoto Prefectural University of Medicine said on Thursday that incomplete clinical data had been used in the study of the drug, marketed in Japan under the name of Diovan, which is commonly prescribed for high blood pressure.

It said that if the researchers had used the patients’ records in their entirety, it was “highly likely” they would have reached a different conclusion. The Kyoto heart study had already been retracted from the European Heart Journal earlier in the year

The university did not dispute the drug’s ability to control high blood pressure, but said it was not necessarily able to prevent strokes and angina, as the study claimed.

The minister, Norihisa Tamura, said he would set up a special committee to work out ways to avoid similar cases in future, and to review ethical guidelines.

[NHK NEWS WEB] 薬効のデータに“操作の疑い”
[東洋経済] 医師主導の臨床試験で、多数のデータ操作が判明