An investigation team at the Kyoto Prefectural University of Medicine disclosed that the results of a study of a drug to treat high blood pressure may contain errors due to manipulation. The team found discrepancies in the patients’ medical records for a study on the drug Diovan from Novartis Pharma.
Results of the study showed that the drug is more effective compared to other similar drugs to reduce brain strokes and angina. But the investigative team discovered that 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. The team looked into the medical records of 223 out of 3,000 patients who participated in the study. It was discovered that 34 of them falsely stated that they may or may not have had a stroke. Hiroaki Matsubara, former professor of cardiovascular internal medicine at the university, led the group that conducted the study and released the report in 2009. But allegations regarding its credibility led to his resignation in February this year.
The investigative team also discovered that one employee from Novartis Pharma was part of the study as a statistical data analyst. When the university contacted the company to interview the employee, they refused, saying the person has already left the company. Novartis Pharma denies that any data manipulation occurred or that they denied the request for the interview. They claim to have contacted the former employee but he/she declined to be interviewed.
Toshikazu Yoshikawa, president of the university, apologized for causing trouble during a news conference. They assured the public that they will be taking further steps to ensure that this will never happen again. An official from the Health Ministry said that once they receive the reports from four other universities who conducted an investigation into their own studies, they will then decide on the best preventive measures for this situation.
[ via NHK ]
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