Novartis Hit by Scandal Over Japanese Drug Studies
Probes Uncover Altered Research Data; Swiss Giant Stands by Heart Medicine Diovan
Faulty Data on Novartis Drug Rattles Japan
Investigations by Japanese universities found data had been manipulated in studies on Diovan, a blood-pressure drug manufactured by Swiss drug maker Novartis. The WSJ’s Kana Inagaki tells Mariko Sanchanta what the scandal means for the company’s business in its second-largest market.
- The Wall Street Journal reported that over the past month two university-led investigations into Novartis-related research discovered data regarding the company's cardiovascular drug Diovan had been "manipulated," casting doubt on claims of the drug's benefits.
- One investigation said the raw data for certain clinical tests in one study did not show reduced cardiovascular risks, while another said raw data on patient hypertension levels was likely altered during the statistical analysis. The universities said their probes did not reach firm conclusions about who altered the data.
- Three other Japanese universities that conducted Diovan research have also opened investigations, but have not yet finished. The health ministry launched its own probe this month.
- Novartis denies involvement in the alleged research distortions, and stands by the efficacy of its angiotensin II receptor blocker.
- Nonetheless, at least eight Japanese hospitals have said they will stop prescribing the medication in the wake of the controversy, with one Tokyo hospital director stating "it's morally problematic to keep using a drug that's faced questions on effects that have been its feature."
- Meanwhile, in the US, FDA spokesperson Erica Jefferson said "the drug has a well-established safety and efficacy profile," adding that "the agency has seen no new safety concerns with this drug."