After Kyoto Prefectural University of Medicine announced on July 11 that the data used in clinical research on Novartis Pharma K.K.’s high blood pressure drug Diovan are suspected to have been manipulated, it came to light that a Novartis employee (who quit in May) was involved in the clinical research not only at the Kyoto university but also at four other universities. A thorough investigation must be carried out to clarify if the research was compromised and guidelines for medical research must be reviewed and revised to avoid conflicts of interest that could taint the integrity of clinical research.
Diovan was developed in the 1990s and sales in Japan began in 2000. Diovan, generically known as valsartan, generates just over ¥100 billion in domestic sales each year. It has been prescribed to more than 1 million patients. Teams at Kyoto Prefectural University of Medicine, Jikei University School of Medicine, Chiba University, Nagoya University and Shiga University of Medical Science started clinical research on the drug in and after 2002, and began publishing scientific papers based on their research in well-known medical journals in 2007.
The teams at Kyoto Prefectural University of Medicine and Jikei University School of Medicine stated in their papers that Diovan was more potent in preventing angina pectoris and strokes than other high blood pressure drugs. After the Japanese Circulation Society and other parties raised questions concerning data used in the research, the five universities launched investigations this year, and the health and welfare ministry established a study panel. After Kyoto Prefectural University of Medicine and Jikei University School of Medicine strongly hinted that data had been manipulated they proceeded to withdraw their teams’ papers.
It also surfaced that the Novartis employee had taken took part in the research at the five universities but concealed his true employment, only introducing himself as a part-time lecturer at Osaka City University. He was involved in the analysis of research data. In addition, it came to light that Novartis Pharma K.K donated a total of ¥1,132.9 million to the teams’ university sections. The Swiss parent firm of the Japanese company said that a third-party investigation commissioned by it revealed no evidence suggesting that the Novartis employee was responsible for manipulating data.
Investigations by the universities also failed to uncover who manipulated the data, thus the truth remains unknown. The panel of the health and welfare ministry should carry out its own thorough investigation that includes direct questioning of the researchers and the former Novartis employee.
The clinical research was important because it involved thousands of patients, and data manipulation could greatly affect people’s health and lives. Oversight of pharmaceutical companies’ corporate donations to universities and of the roles played by their employees in university clinical research must be strengthened to prevent conflicts of interest and to ensure that research results are accurate.