Japanese researchers have withdrawn studies that promoted the benefits of one of Novartis’s best selling drugs, the heart medicine Diovan (valsartan).
The news of the withdrawal came after university-led investigations found data had been manipulated to create false results, according to seekingalpha.com. At least eight hospitals in Japan have said they will stop prescribing the drug. One university investigation said the raw data for the clinical tests in one study didn’t show reduced cardiovascular risks, the Wall Street Journal reports. Another investigation said raw data on patient blood pressure levels was likely altered during the statistical analysis phase of the study. The universities reached no firm conclusions about who altered the data.
The impact to Novartis is expected to be limited in the U.S., where Diovan is a well established medication. Its U.S. patent expired in 2012, opening the market to generic valsartan. The Wall Street Journal reports that Diovan has been used to treat millions of patients in the U.S. for more than 15 years. Erica Jefferson, a spokeswoman for the U.S. Food and Drug Administration (FDA), said, “The drug has a well-established safety and efficacy profile,” adding that the FDA “has seen no new safety concerns with this drug.” A Novartis spokesman said the company stands by Diovan’s health benefits, citing unchallenged research from 25 other countries, including the U.S
Diovan is an angiotensin receptor blocker (ARB), used to treat high blood pressure and heart failure. Lowering blood pressure can reduce the risk of stroke and heart attack. According to the Mayo Clinic, valsartan is also used to treat heart failure and left ventricular failure after a heart attack.