Another study report on Novartis drug found inappropriate

Kyodo

Shiga University of Medical Science on Thursday became the third Japanese institution to conclude that a clinical study report on Novartis Pharma K.K.’s Diovan blood pressure-lowering drug contained doubtful data and was inappropriate.

A Novartis Pharma employee’s participation in the clinical study on the drug was problematic, said the university’s in-house committee investigating suspected manipulation of clinical data for the report.

The Kyoto Prefectural University of Medicine and the Tokyo-based Jikei University School of Medicine earlier found that the employee had been involved in their respective studies on the drug and their reports, which have since been retracted, included manipulated data.

The Shiga university committee said 10.1 percent of patient data in its report released in 2007 failed to match original data in clinical records.

The committee said that overall, the data seem to have been changed to reflect figures, which worked to the advantage of Diovan.

The university in Shiga Prefecture conducted the clinical study, covering 150 hypertension patients with diabetes, between 2003 and 2006 to check if Diovan could not only lower blood pressure but protect kidneys.

Novartis Pharma, a sales unit of Swiss pharmaceutical group Novartis, had the employee participate in the study and contributed ¥60 million to the university.

In addition to the three institutes, Chiba University and Nagoya University have implemented clinical research on the same Novartis drug.