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A Japanese university Wednesday said it would retract a study that touted the effectiveness of a blood pressure drug made by Swiss pharmaceutical giant Novartis because it was based on fabricated data.
The move was the latest chapter in a growing scandal over allegations that bogus data were used in a string of Japanese university studies for the drug Valsartan which exaggerated its effectiveness in preventing strokes and angina.
On Wednesday, Tokyo's Jikei University School of Medicine said it would retract research that appeared in respected medical journal The Lancet six years ago.
"We will report the conclusions of our investigation to Lancet so the study can be withdrawn," a university spokesman told AFP.
The school's probe concluded that the research, led by one of Jikei's professors, relied on data analysis by an unnamed former Novartis employee, who was also involved in at least one other school's research which has been thrown into question.
The fresh allegations come less than two weeks after Japan's health minister said it was very likely that tests for Valsartan were based on incomplete clinical data.
Jikei University's probe also found it had received about $85,000 worth of grants from Novartis for the study, pointing to a conflict of interest, it said.
The local unit of Novartis could not be immediately reached for comment Wednesday.
On Monday, Yoshiyasu Ninomiya, head of the Swiss firm's Japanese unit, apologized for the involvement of an employee in university studies.
But he stood by other tests that said Valsartan is effective at preventing strokes and angina, as well as controlling high blood pressure.
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.
Three other Japanese universities are investigating similar claims, local media reported.
© (C) 2013 AFP
4 Comments
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Cricky
Mmmm results for money, who would have thought! Next we hear this/ these people are working for an unnamed power company.
oyatoi
In order for a drug company to obtain release approval for this foreign wonder drug, the Ministry of Health in Japan mandates clinical trials of the drug on human guinea pigs throughout the archipelago. Once all the data is in, only then is approval granted.
That this drug has already passed through all the hurdles and gone on to become a massive money spinner for the company is a damning indictment of the lax oversight of the drug regulatory authority here which signed off on the drug makers fabricated claims about the drugs efficacy. Clinical trials in safety Japan are supposedly governed by all sorts of safeguards to prevent such fraudulence, yet as weve seen here the system is only as strong as its weakest link. Blaming it all on an unamed former Novartis employee just aint gonna cut it, and before this things through we`re going to see a few more gray eminences falling on their proverbial sword in atonement.
TumbleDry
Former Novartis employee being Japanese by any chance? Did Novartis pay the University for bogus data? Seems not. Not an evil foreigner thing it seems. Just old local mess tried to be put on a foreign company?