2013年4月30日火曜日

Pharmalot: Novartis Admits Employees Participated In Independent Diovan Trials

Novartis Admits Employees Participated In Independent Diovan Trials


For the first time since opening an internal probe into clinical trials run in Japan for its Diovan blood pressure drug, Novartis has acknowledged signs of wrongdoing. In a statement on its web site, the drugmaker has admitted that two employees had varying levels of involvement in clinical trials that were initiated by investigators but were supposed to have been independent.
“Our current understanding is that one of our former employees had varying levels of involvement in five investigator-initiated (Diovan) trials in Japan. In addition, a second former employee, who reported to the first former employee, had involvement which was limited to one of these trials,” the drugmaker writes.
The admission comes after several papers were retracted and a prominent researcher, who was the principal investigator in most cases, resigned a position from a major university. The cascading chain of events has prompted increasingly unflattering coverage in the media in recent months, which ultimately prompted Novartis to investigate.
We will repeat some background from an earlier story: The controversy erupted after several papers co-authored by Hiroaki Matsurbara, formerly of Kyoto Prefectural University, were retracted. These included the main publication of the Kyoto Heart study, which was published in the European Medical Journal in 2009 and claimed Diovan reduced the risk of heart attacks and strokes, which Novartis used in its promotions. The study helped Diovan become a huge seller in Japan (the back story)..
Another paper found Diovan helped diabetics avoid heart disease and a third paper claimed the drug could benefit high-risk patients with high blood pressure. More recently, Novartis Pharma employee Noburo Shirahashi was listed as a statistician on yet another paper concerning Diovan – the Jikei heart trial that was published in The Lancet (see here) - but he was only listed as being affiliated to Osaka City University, which has received more than $1 million in donations from the drugmaker.
So what has Novartis learned? The “first former employee was mentioned in the acknowledgements of several papers for investigator-initiated studies” and the drugmaker admits he should have requested the authors “to identify him as a Novartis employee on all publications. In some cases, he ran data analysis, although Novartis insists “there has been no indication” so far that this led to “any manipulation of the data in these studies.”
The drugmaker also maintains there is nothing to suggest a “specific company strategy to integrate” the employee into the five trials, but his superiors in Japan knew of his participation and supported his activities. Why? “They believed that employees of a business that had academic titles could perform clinical research support as academics, without any conflict of interest issues arising” (HERE IS THE STATEMENT).
But Novartis says there is no indication they “knew or approved” of his decision not to disclose his ties to the drugmaker in the published studies. At the same time, “some, if not all, of the physicians involved in conducting the studies were aware of his employment by Novartis.” In other words, everyone but the public knew of the conflict.
The drugmaker also corrected previous statements about the involvement of its Japanese unit in the Kyoto Heart study, which “were provided based on the information which was available at the time and were believed to be accurate. We are correcting those statements by issuing this update based on the latest information which was obtained from the ongoing independent investigation and we apologize for the statements made without verification.”
But there is more to come. Novartis (NVS), notes that the investigator-initiated trials were not used for registering Diovan with regulatory authorities, says its probe is ongoing.
STORY ENDS HERE


http://www.pharmalive.com/novartis-admits-employees-participated-in-independent-diovan-trials

http://megalodon.jp/2013-0525-1158-19/www.pharmalive.com/novartis-admits-employees-participated-in-independent-diovan-trials

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