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In Japan, Novartis Official Apologizes for Problematic Drug Trials, Promises Reforms
3 October 2013 1:15 pm
TOKYO—After a deep ritual bow while cameras clicked and flashed, David Epstein, division head of Novartis Pharmaceuticals, apologized for "the great concern and inconvenience experienced by patients, their families, and health care practitioners" as a result of flawed Japanese clinical trials involving one of the company’s drugs. Novartis employees participated in the trials of the hypertension drug Diovan, but the potential conflict was not reported by researchers. And a ministry of health panel reported earlier this week that there was data manipulation in scientific reports resulting from the trials, but could not conclude who did it or why.
Diovan, known generically as valsartan, was approved to treat hypertension in Japan in 2000. Later clinical trials conducted at several universities sought to study whether the drug also helped prevent heart disease and stroke. Investigators found that a former Novartis employee helped two university research teams with data analysis, though that person's link to the company was not disclosed in published papers.
The various investigations have indicated that the university researchers turned to Novartis employees for help in the statistical analysis. "In retrospect, people did not have the skills in academia to conduct these trials, nor did we have the controls in place to ensure our people participated in an appropriate manner," Epstein said. He said that he agreed with the interim finding of the health ministry panel that both Novartis and the universities involved shared blame.
"We will correct what has been done and make sure it doesn't happen again," Epstein said, explaining that the company has already taken corrective steps. He said the fact that the studies were controversial at the time they were published should have gotten more attention from the company. Their countermeasures include making sure that, in the future, published data are complete and proper.
Regarding ongoing probes, including the possibility that the company violated drug marketing laws, Epstein said: "We are committed to cooperate with any government investigation."