Can’t spell Novartis without VART: Drug study retracted for conflict of interest, data issues

JHH(Cover).inddA major scandal in Japan over the Novartis hypertension drug valsartan has resulted in a retraction from the Journal of Human Hypertension. 

Frequent Retraction Watch subject Hiroaki Matsubara resigned his post at Kyoto Prefectural University in 2013, after his work on valsartan was shown to be riddled with data errors and undisclosed conflicts of interest.

Also that year, suspicions about Chiba University hypertension researcher Issei Komuro’s work were first raised by an anonymous blog, which detailed numerous image manipulations in the researcher’s published works. Komuro, who frequently collaborated with Matsubara, has been a senior author on a number of valsartan papers, including the now-retracted one, which reported the results of Novartis-sponsored Valsartan Amlodipine Randomized Trial in 2011 without reporting the Novartis funding.

The paper, which has been cited three times, according to Thomson Scientific’s Web of Knowledge, had already been subject to a correction in 2013

The authors would like to correct the affiliation of Nobuo Shirahashi, who was included in the acknowledgements.

Therefore, the last sentence of the acknowledgements:

‘Statistical analysis organization: Nobuo Shirahashi (Clinical Epidemiology, Osaka City Graduate School).’

Should read: ’Statistical analysis organization: Nobuo Shirahashi (Novartis Pharma KK).’

Forbes reported in September 2014:

The Chiba University investigation obtained testimony from VART investigators and found multiple problems with the paper, including the surreptitious involvement of a Novartis employee. (A similar problem occurred in the Matsubara trials.) The investigation concludes that the VART paper in Hypertension Research should be retracted.

To date the journal has not retracted the paper. I am informed by a reliable source in Japan that a retraction is widely anticipated in the Japanese hypertension community.

Looks like the source was right. Here’s the notice for “Effects of valsartan and amlodipine on home blood pressure and cardiovascular events in Japanese hypertensive patients: a subanalysis of the VART”:

Retraction to:Journal of Human Hypertension (2012) 26, 656–663; doi:10.1038/jhh.2011.91; published online 13 October 2011

The paper has been retracted due to concerns raised by the publishing institution regarding problems with management of conflicts of interest and with the reliability of the published data.

The corrigendum associated with this article, doi:10.1038/jhh.2013.58 has also been retracted.

Nature told us:

We do not generally comment on retractions.  With regards to your request for further information, we would refer you to the retraction notice which you link to and suggest that you contact the authors’ institutions with the specific questions that you may have.

We’ve tried several people at Chiba University Graduate School of Medicine, including the first author. We’ll update if we find anything out.

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