The Mainichi： Drug company may have given company-wide support to alleged data fudging
Drug company may have given company-wide support to alleged data fudging
Pharmaceutical company Novartis Pharma K.K., a former employee of which is suspected of fudging statistical data in clinical research on the company's blood pressure drug Valsartan, or Diovan, may have given company-wide support for the scam, it has been learned.
Some of the suspected research was held at Jikei University in Tokyo from 2002. Former professor at the school Seibu Mochizuki, 72, has told school authorities that the former Novartis Pharma K.K. employee did not say he belonged to the company and presented a business card that only said he was a part-time teacher at Osaka City University.
According to Osaka City University, the employee carried the title of a part-time teacher there from 2002 through 2012 academic years, but did not actually teach. Jikei University says that the employee had four different kinds of business cards he used, both with and without the Novartis Pharma K.K. name on them.
Meanwhile, a Novartis Pharma K.K. official in charge of marketing introduced the employee to Mochizuki as a "statistics specialist" to aid in research.
According to Novartis Pharma K.K. internal documents, due to rapid growth in the blood pressure drug market it upped its original sales goal for Valsartan, which it began selling in November 2000. In 2002, the company started a project team to aim for 100 billion yen in sales of the drug a year, twice the initial goal of 50 billion yen. An insider reveals that the budget for advertising the drug was increased. The company pitched the idea of a clinical test of its drug to various universities, hoping to get results that would show its drug had additional benefits besides lowering blood pressure.
The former employee participated in clinical tests on the drug at five universities and in 2009 received an award from the company president. The president at that time was Hiroyuki Mitani, currently top adviser to the company. He says, "I didn't know the research papers were suspicious. Now I regret (giving the award.)"
The former employee belonged to the company's marketing division. Many of the employee's superiors at the time have since left the company. Novartis Pharma K.K. has investigated the matter but says that it did not find conclusive evidence of data tampering by the former employee or instruction by the former employee's bosses to tamper with research data. However, the company did not question those bosses that have since left the company because, it says, it does not have the legal authority to compel them to speak.
The clinical research at Jikei University was published in 2007 in the leading medical journal "The Lancet." From soon after the publication, doubts over the research's authenticity were raised from experts in different countries. An insider source says that, "In order to quell the skepticism, an article reporting on a round-table talk by domestic and foreign authorities in the field of high blood pressure was run in a specialist magazine."
Large-scale clinical tests on over 3,000 patients, like those done with Valsartan at Jikei University and Kyoto Prefectural University of Medicine, are said to cost as much as billions of yen to tens of billions of yen. Novartis Pharma K.K. gave scholarship donations, which do not have their usage limited, worth 104.4 million yen to Kyoto Prefectural University of Medicine from the academic years 2009 to 2012, and worth 84 million yen to Jikei University from the academic years 2005 to 2007. Novartis Pharma K.K. has said that it gave the donations "with the intention and expectation that they would be used in support of research."
A man who used to work at Novartis Pharma K.K. said, "For donations of tens of millions of yen, explanations to executives and their agreement is necessary. The top levels of management won't be able to deny knowledge of the donations."
An investigative committee under the direct jurisdiction of the health, labor and welfare minister is to question the former employee suspected of data tampering on Aug. 9.