Minister says drug data likely fabricated
Source: AFP |
July 13, 2013, Saturday
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Print Edition
Print Edition
JAPAN'S health minister said yesterday it was very likely that test data on a widely used blood pressure drug from Swiss pharmaceutical giant Novartis had been fabricated and falsified.
Norihisa Tamura described as "extremely regrettable" an incident in which an employee of the world's No.2 drug maker had hidden 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 on Thursday incomplete clinical data had been used to support this finding and that had patients' records been used 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.
The firm used the study to market its drug, playing up its supposed other benefits.
Tamura said the case "highly suggests fabrication and falsification of data" and he would be establishing a special committee to work out how to prevent this in future studies and to review ethical guidelines.
In a statement yesterday, Novartis stressed that the university was not able to conclude that there was intentional wrong doing.
Norihisa Tamura described as "extremely regrettable" an incident in which an employee of the world's No.2 drug maker had hidden 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 on Thursday incomplete clinical data had been used to support this finding and that had patients' records been used 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.
The firm used the study to market its drug, playing up its supposed other benefits.
Tamura said the case "highly suggests fabrication and falsification of data" and he would be establishing a special committee to work out how to prevent this in future studies and to review ethical guidelines.
In a statement yesterday, Novartis stressed that the university was not able to conclude that there was intentional wrong doing.
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