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Novartis blockbuster linked to retracted papers

Japanese media are reporting some uncomfortable ties between Novartis and some suspicious Japanese research linked to valsartan (Diovan), a lucrative blood-pressure drug.

Sales of the drug hit ¥119.2 billion (US$1.3 billion) in 2011, making it the top-selling drug for Novartis’s Japanese subsidiary and the third-best-selling drug in Japan. The boom in sales followed reports that it not only lowered blood pressure but also reduced the risk of stroke and heart attack. Novartis used the results in advertisements.

But then Hiroaki Matsubara, the professor at the Kyoto Prefectural University of Medicine who was heading the group that published those results, ran into trouble. In December 2012, the Japanese Circulation Society retracted two of Matsubara’s papers, citing “serious errors in data analysis” in both. A 2012 paper claimed that the drug helped diabetics to avoid heart disease. The other, published in 2011, claimed benefits for high-risk hypertensive patients. Matsubara stood by his conclusions, saying that the errors were accidental. A university committee in January found no signs of misconduct.

But the situation has spiraled since then. In February, the European Society of Cardiology retracted a similar 2009 paper on valsartan by Matsubara. The notice raised the level of alarm: “Critical problems existed with some of the data reported in the above paper.”

Since then the Japanese Circulation Society has requested another investigation by Matsubara’s university. On 28 February, he resigned. A day later, the university began an investigation.

Novartis has maintained its distance from the research. When it was revealed that a scientist working for Novartis co-authored an earlier study (also on valsartan) with the group but used an Osaka City University affiliation, Novartis responded by saying that its employee has an adjunct position at the university and, “being famous in the statistician community, merely gave advice on what type of statistical analysis to use”. Yesterday, The Mainichi newspaper also reported that Novartis invested ¥100 million in the group’s research.

 

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    Florian Fritzsche said:

    The ultimate question seems how to separate health and money-making. The only difference to the business model of more shady drug dealers is the level of sophistication and PR work.
    Will this be just another incident to be reported and forgotten (for whatever reasons), or will responsible governments start to act in the interest of ALL their citizens?
    So long, I will risk my heart disease and stay sober.

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