viernes, 7 de junio de 2013

NOVARTIS: A dónde van con DIOVAN...? (I): Diovan trials may have been run by Novartis staff

Several post-marketing clinical trials of the blockbuster blood pressure drug Diovan may have been run by employees of the drug’s manufacturer Novartis

 While the firm is not naming the employees or the trials by name, one is believed to relate to the cardiologist Hiroaki Matsubara, a former Kyoto Prefectural University researcher, who has had a number of his Diovan studies retracted in Japan, the US and Europe. 

 Another large trial, the Jikei Heart Trial, also came under scrutiny when it was revealed that a Novartis employee, Nobuo Shirahashi, was involved with both studies, but his only listed affiliation was Osaka City University. 

 Novartis originally said Shirahashi had ‘an adjunct position’ at the University and, “being famous in the statistician community, merely gave advice on what type of statistical analysis to use”. 

 But in March Japanese newspaper The Mainichi reported that Novartis invested ¥100 million in the University’s research. Novartis admits in its statement “one of our former employees [presumably Shirahashi] had varying levels of involvement in five investigator initiated valsartan trials in Japan”. 

 Novartis went on: “There have been allegations of an undisclosed conflict of interest related to five Japanese post-registration investigator initiated valsartan [Diovan] trials

 “The conflict of interest allegations include two former Novartis employees who were allegedly involved in the trials and who were not appropriately disclosed in the trial publications as Novartis employees.”  (Más)

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NOVARTIS: A dónde van con DIOVAN...?

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