Japan’s Health Ministry said it will be investigating the claims that health care company Novartis AG may have violated some laws when it used allegedly manipulated data in its drug trial tests for the blood pressure drug Diovan. In the draft report of the investigative committee, it says that the charges against the pharmaceutical company may cause harm to Japan’s national interest.
The report stated that part of the country’s growth strategy is “pushing for high-quality clinical studies necessary to develop pharmaceuticals” and allegations like this can affect the trust and confidence of the international medical community in Japan. The ministry will be conducting on-site investigations at Novartis Pharma, the Japanese arm of the company, to check if they committed violations against the Pharmaceutical Affairs Act.
Earlier this year, an investigative team from Kyoto Prefectural University of Medicine revealed that there may have been data manipulation in the results of the study for Diovan as they discovered there were discrepancies in the patients’ medical records. While the drug is indeed effective in treating high blood pressure, the conclusion that it is better than other drugs for brain strokes and angina may be wrong. Hiroaki Matsubara, a former professor of cardiovascular internal medicine at the university, led the study conducted in 2009, but when the allegations started coming up, he resigned from the university. They also found out that one employee from Novartis Pharma was part of the study as a statistical data analyst. A second Japanese university, the Jikei University School of Medicine, has also investigated whether the study conducted at the institution also had faulty data.
[ via Global Post ]