15 Jul 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Japan's health minister Mr Norihisa Tamura has pointed out that the test data on a widely used Novartis blood pressure drug had been fabricated and falsified and has termed the incident "extremely regrettable". The controversy surfaced when a Novartis employee hid his affiliation during a medical study into the effects of Valsartan.
A study at Kyoto Prefectural University of Medicine concluded that the drug, developed to treat high blood pressure, could also help to prevent strokes and angina. But the university said that the incomplete clinical data had been used to support this finding and that if the firm used patients' records in their entirety, the study would have had a different conclusion.
While Valsartan was effective in controlling high blood pressure, the university said the medication did not necessarily have any effect on strokes or angina. Novartis sells the drug under the name Diovan in Japan, where it is one of the most commonly prescribed drugs on the market. It is licensed for use in more than 100 countries.
The study was led by professor Mr Hiroaki Matsubara, and included among its researchers an un-named Novartis employee, who was identified as an adjunct lecturer at Osaka City University. Mr Matsubara resigned his post at the university in February after scientific journals pulled his papers citing inconsistent data and as the school launched a probe.
Novartis said in a statement that the university was not able to conclude that there was intentional wrong-doing. The Swiss giant said the inconsistencies might be unintentional errors, not the "manipulation" suggested by the university.