Novartis has apologised to patients in Japan over the alleged manipulation of data in five trials of its blockbuster blood pressure drug Diovan.
After meeting health minister Norihisa Tamura in Tokyo, the head of Novartis’ pharma division, David Epstein, said: “We express our deep regret for the concern that the issue has brought to patients, to the medical society as well as the ministry.”
In comments reported by Reuters, he went on: “We are very willing to work with them and take additional actions and potential sanctions in order to bring the issue to a good conclusion.”
There is no detail on what sanctions may be forthcoming, but Novartis has been under the microscope since allegations emerged that several post-marketing clinical trials of Diovan (valsartan) may have been run by company staff.
The health ministry is to make its own report into the affair but Epstein has said that the activities of one ex-employee went “way beyond what we consider appropriate” - although the firm has never named anyone.
However, one cardiologist, Hiroaki Matsubara, a former Kyoto Prefectural University researcher who unexpectedly resigned from his post in February, had a number of his Diovan studies retracted in Japan, the US and Europe.
Another study, the Jikei Heart Trial, came under scrutiny when it was revealed that Novartis employee Nobuo Shirahashi was involved with both - although his only listed affiliation was Osaka City University.
Japanese newspaper The Mainichi has previously reported that Novartis invested ¥100 million in the university’s research.
In December 2012, the Japanese Circulation Society retracted two of Matsubara’s papers, citing ‘serious errors in data analysis’ in both.
A 2012 paper claimed that Diovan helped diabetics to avoid heart disease - the other, published in 2011, claimed benefits for high-risk hypertensive patients.
In addition there have been five retractions of Matsubara’s Diovan studies by the American Heart Association, and the major Kyoto Heart Study was also retracted from the European Heart Journal.
Matsubara has stood by his conclusions, saying that the errors were accidental, and a Kyoto Prefectural University committee in January found no signs of misconduct.
Adam Hill
http://www.pharmafile.com/news/181134/novartis-sorry-diovan-data?
After meeting health minister Norihisa Tamura in Tokyo, the head of Novartis’ pharma division, David Epstein, said: “We express our deep regret for the concern that the issue has brought to patients, to the medical society as well as the ministry.”
In comments reported by Reuters, he went on: “We are very willing to work with them and take additional actions and potential sanctions in order to bring the issue to a good conclusion.”
There is no detail on what sanctions may be forthcoming, but Novartis has been under the microscope since allegations emerged that several post-marketing clinical trials of Diovan (valsartan) may have been run by company staff.
The health ministry is to make its own report into the affair but Epstein has said that the activities of one ex-employee went “way beyond what we consider appropriate” - although the firm has never named anyone.
However, one cardiologist, Hiroaki Matsubara, a former Kyoto Prefectural University researcher who unexpectedly resigned from his post in February, had a number of his Diovan studies retracted in Japan, the US and Europe.
Another study, the Jikei Heart Trial, came under scrutiny when it was revealed that Novartis employee Nobuo Shirahashi was involved with both - although his only listed affiliation was Osaka City University.
Japanese newspaper The Mainichi has previously reported that Novartis invested ¥100 million in the university’s research.
In December 2012, the Japanese Circulation Society retracted two of Matsubara’s papers, citing ‘serious errors in data analysis’ in both.
A 2012 paper claimed that Diovan helped diabetics to avoid heart disease - the other, published in 2011, claimed benefits for high-risk hypertensive patients.
In addition there have been five retractions of Matsubara’s Diovan studies by the American Heart Association, and the major Kyoto Heart Study was also retracted from the European Heart Journal.
Matsubara has stood by his conclusions, saying that the errors were accidental, and a Kyoto Prefectural University committee in January found no signs of misconduct.
Adam Hill
http://www.pharmafile.com/news/181134/novartis-sorry-diovan-data?
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