The data used in a clinical study on Novartis Pharma K.K.’s blockbuster blood pressure drug Diovan were manipulated, Kyoto Prefectural University of Medicine has revealed.
The research, based on around 3,000 Japanese with high blood pressure, was started in 2004 by Hiroaki Matsubara, a former professor at the school who published papers between 2008 and 2012.
His study concluded that Diovan, generically known as valsartan, is more potent in reducing angina and strokes than other antihypertensive medicines.
Facing reporters Thursday, a university official said its investigation showed that “it is highly likely that this conclusion was erroneous.” The university said it does not question the drug’s effectiveness at lowering blood pressure.
Asked if Matsubara could have deliberately tweaked the data, Shinji Fushiki, vice president of the university, said the researchers’ conflicting accounts are making it hard to pin down.
“Those involved in the research give accounts that do not match up with each other, so we don’t know who did manipulation where,” Fushiki said.
Last December, Matsubara requested that his papers be withdrawn because of “data problems” after the data in his study were questioned.
Data manipulation in such a large clinical study is thought to be rare, and it is believed the university is considering filing a criminal complaint.
A lawyer representing Matsubara said the researcher did not alter the data.
“We are surprised by what was said at the news conference. We would like to withhold any specific comments at this point. (Matsubara) has not been involved in the manipulation,” lawyer Rei Hashiguchi said.
Matsubara’s research on the drug has been called into question on other fronts as well. A Novartis Pharma employee was involved in analyzing statistical data but the employee’s affiliation was not indicated in the papers. Matsubara’s research team was also known to have received more than ¥100 million in grants from the drugmaker.
Novartis Pharma, a unit of the Swiss pharmaceutical group Novartis, said in a statement that it “cannot confirm if there had been any deliberate acts” of data manipulation in the course of research because of the inadequate account in the university’s report.
The university’s report, however, said Novartis Pharma refused its request to interview the employee in question. The drug company said the request was rejected at the strong behest of the employee, who has retired from the company.
While noting the university’s acknowledgement that its drug effectively lowers blood pressure, Novartis said it regrets the case is causing tremendous concern among university officials and patients. Diovan is one of its flagship products and generates just over ¥100 billion in revenue in Japan.
The Novartis employee in question was also involved in Diovan research at Tokyo Jikei University, Chiba University, Nagoya University and Shiga University of Medical Science.