A number of papers co-authored by Novartis, Osaka City University, and Kyoto Prefectural University statistician, Hiroaki Matsurbara, were retracted from their respective journals because of significant data analysis errors. These data analysis errors led to conclusions that Diovan showed benefit for off-label indications. Novartis, then, used these conclusions to promote Diovan and collected $5.6 billion in profit.
Novartis claims that the results of the studies co-authored by Matsurbara, including the Kyoto Heart Study, which helped Diovan become a big seller in Japan, were not used by Novartis in their promotional campaigns for Diovan and, instead, used other publications that "...demonstrated the benefits of valsartan beyond its proven blood pressure-lowering efficacy." These studies include Val-HeFT and VALIANT.
In response to these allegations, Novartis released an official statement: "Novartis takes these allegations very seriously and has launched a comprehensive investigation with independent third party experts to review these allegations", but refused to provide any information about the experts to be consulted by Novartis.
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