The Lancet just retracted the Jikei Heart Study:
RETRACTED: Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality study, 2007
This retraction followed the retraction by the European Heart Journal of the Kyoto Heart Study in February this year :
RETRACTED: Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: KYOTO HEART Study, 2009
Both of these studies found benefit for the blood pressure-lowering drug valsartan (Diovan, made by Novartis). Both had several authors in common.
There was an investigation at Jakei University about the Jakei Heart study. It found:
“We believe, therefore, that the data were intentionally altered.” ... “We suspect that the data were altered during their statistical analysis.”The person responsible for the statistical analysis, Mr. Shirahashi, had taken an unpaid position with Jakei University for several years while being employed by and paid by Novartis. This conflict was not revealed in the study's publication.
Note that it took several years to investigate and formally retract these studies, during which time valsartan continued to generate profits. In 2005, Valsartan was prescribed more than 12 million times in the United States and global sales were approximately $6.1 billion in 2010. It almost doesn't matter that they get caught. Shirahashi recently retired from Novartis, and Novartis made their money on valsartan, the patent for which expired in September 2012.
Also, the senior author of the retracted Kyoto Heart Study, Dr. Matsubara, is at the root of several allegations of fraud involving published studies in the journals Hypertension, Circulation, and Circulation Research, all American Heart Association journals.