Saturday, July 20, 2013


Last Friday, the Japanese Minister of Health Norihisa Tamura and officers of the Kyoto Prefectual University, issued a statement to say it is very likely that the data in the Kyoto Heart Study were fabricated, making it null and void. This because the lead investigator, Dr Hiroaki Matsubura, was found to have committed fraud and last year 5 premier journals had retracted the article from their publication.
This brings to question the other paper that Dr Hiroaki was also the lead author, namely the Jikei Heart Study.
Of course both study involved the use of Valsartan ( Novartis ). Both  the Kyoto heart Study , which was announced with great fan fare at ESC 2010, Stockholm, and Jikei Heart study showed that the use of Valsartan was associated with a lowering of MACCE when added to conventional anti-hypertensive therapy.
Actually, the fraud was first brought to light by internet blogs, namely Retraction Watch and Cardiobrief. Their wok showed that the numbers did not add up and so the conclusion to the study was incorrect.
Dr Hiroaki Matsubura had since resigned from the Kyoto Prefecture University.

This brings to light the bigger question of evidence based edicine. Does that mean that all the clinical guidelines that used data from these two studies should now be revised. nd also the culpability and responsibility of Novartis, at Basel. Did they know that the numbers did not add up? Did they ask the important questions and the pertinent time? I must say that in 2010, I felt that the Kyoto Heart Study was good for Asian Cardiac patients and that it may have influence me in my prescribing pattern. I know that Valsartan certainly did not harm my patients.

Well we all learn our lessons. Is this problem only confined to Novartis and Valsartan or is there a wider issue with all the other multinational pharmas? Has any one committed hara kiri, or is that no longer fashionable?


Diane J Standiford said...

Taking meds is always a risky business. :(

hmatter said...

Agreed Diane.
However, some patients like medication and sometimes it is so difficult to talk them out of it.