Distortion of Drug Data

Special Investigation Division of Tokyo District Public Prosecutor’s Office arrested a former employee of Novartis Pharma, Nobuo Shirahashi, on suspicion of violation against Pharmaceutical Affairs Law on Wednesday. He was suspected to have committed to distortion of data about medicine for treatment of hypertension, Diovan, in some medical colleges. The arrest might be a first step to investigation on greater scandal.

Shirahashi participated in a study of Kyoto Prefectural University of Medicine, in which he analyzed data about clinical test of Diovan. The data showed superiority of Diovan to other rivaling drugs, and the result was published on overseas magazine in 2009. Shirahashi was also involved in studies of other four universities, and three of those studies concluded Diovan as effective in lowering blood pressure or working for diabetic treatment. Novartis Pharma advertized the effect of Diovan taking advantage of data in those studies, and Diovan sold ¥100 billion last year.

Not only participation of an employee of drug company in data analysis was worth amazing, Shirahashi was suspected to have submitted distorted data to the universities. While actual result of experiment on 223 cases was that two with Dioban and other two with other medicine suffered from stroke, Shirahashi distorted it to only one with Dioban and eleven with other medicine invited stroke. Because prescription of Pharmaceutical Affairs Law was three years, the prosecutor’s office arrested Shirahashi not on data distortion in 2009, but on a similar study in 2011.

Novartis Pharma paid ¥1.1 billion to those five universities that cooperated in clinical study of Diovan. There must have been a deal between university and company. University needs money for study, and company needs academic authorization on their products. This is a typical connection of business and academism.

If the universities recognized the distortion of data by Shirahashi, they may also be accused in violation of the law. Moreover, it is unlikely that Shirahashi could do all of those by himself without any help from Novartis. If the company had deeply been involved in those false activities, it would be a great scandal of medical industry.

Japan has a lot of regulations on medical study and treatment. It took a long time to deregulate generic medicines, because of high pressures from medical doctors negative for selling them. Ministry of Health, Labor and Welfare made a new guideline, which required clinical studies to have third party supervisor. Business group of drug companies decided not let their employees to be involved in clinical studies. However, same kind of crime will not eliminated as long as competition between drug companies would exist.