Medical University Study in Kyoto manipulated data

I work in research setting, and this news caught my attention. According to the investigation conducted by the Kyoto Prefectural University of Medicine, the results of a clinical trial to study a drug to treat high blood pressure were manipulated and as a result, it contain errors. The investigation team found discrepancies in the patients’ medical records for this clinical trial.

The original result suggested that the drug Diovan from Novartis Pharma was more effective in treating brain strokes and angina. Drug is effective in treating high blood pressure, but this drug is not anymore effective in treating brain strokes and angina than other drugs available in the market. The investigation team reviewed 223 patients’ medical records out of 3000 participants but 34 of them falsely stated that they have or have had a stroke. A former professor of cardiovascular internal medicine at Kyoto University resigned in February this year.

The investigative team also found that there was a conflict of interest. One employee from Novartis Pharma was part of the clinical trial as a statistical data analyst, but Novartis Pharma denies the allegation that data manipulation occurred. Toshikazu Yoshikawa, president of the university apologized for the trouble during a conference. Matsubara, who was leading this clinical trail investigation have received more than 100 million yen in grants from the drugmaker.

Diovan has generated over 100 billion yen in revenue in Japan.

I wonder if this is the first case of research groups falsifying the data to receive the credit and funding from the pharmaceutical companies. Nevertheless this is unethical, and Kyoto university should do further investigation to decide whether to file a criminal complaint to the principal investigator of the research.