
MASSDEVICE ON CALL — Two former Novartis AG (NYSE:NVS) employees were involved in a massive data fabrication scandal surrounding the Kyoto Heart Study, a post-market trial examining the company’s Valsartan drug in more than 3,0000 patients.
The scandal broke when prominent Japanese cardiologist Dr. Hiroaki Matsubara was accused of fabricating study results, prompting medical journals Circulation, Circulation Research, and Hypertension to retract 5 studies connected to the doctor’s Kyoto Heart Study research, according to TheHeart.org.
Novartis has since announced that it wrapped up a 3rd-party investigation of its employees’ involvement, confirming their role in the analysis of the heart study results. The accused doctors are no longer employed at Novartis.
A company statement said the "former employees and their managers misunderstood the appropriate level of involvement," and confirmed conflict of interest issues.
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