A few weeks after one Japanese university reported possible data manipulation in a study done on a Novartis Pharma drug, the Jikei University School of Medicine has found out through an investigation that the research conducted in their school may have also been tainted. The guest professor who led the study may have been financially involved with the pharmaceutical company, while a former employee may have altered the data as well.
The chairman of the Jikei investigation committee, Kazuhiro Hashimoto, said that their interim report showed that a former worker may have manipulated the clinical research data on Diovan, a drug that purports to lower blood pressure. A large part of the blood pressure data was different from the actual medical records. This data was the basis for the paper written by the leader of the research group, guest professor, Seibu Mochizuki. The paper also claimed that the data analysis group is independent from Novartis, despite the fact that the former employee was part of the research group.
The interim report also showed that Novartis donated 84 million yen between 2005-2007 to a Jikei division where Mochizuki was part of, although that fact was mentioned in the paper he wrote and there are no supposed ethical issues. The investigation therefore concluded that the professor’s paper lacks credibility and is not reliable due to the reasons stated. Mochizuki has volunteered to withdraw his paper due to the doubts that have come out.
Earlier this month, an investigation team at the Kyoto Prefectural University of Medicine also revealed that they found discrepancies in the medical records of the patients who participated in the study, and that the same former employee participated as a data analyst in the research. Novartis however said that a third-party investigation concluded that there was no evidence the former employee altered the data.
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