As if we didn't have enough difficulty interpreting results when study design is inadequate, blinding is violated, sample sizes are underpowered, or there are differences in enrollment – we must also be worried about gross scientific misconduct.
This concerns the Jikei Heart Study and the Kyoto Heart Study – evaluations of valsartan conducted and published in 2007 and 2009, respectively. In short, a series of investigations into the integrity of the studies revealed the following, as quoted:
"We believe, therefore, that the data were intentionally altered."and
"We suspect that the data were altered during their statistical analysis."The Lancet, in their retraction notice, note specific challenges in following up and identifying the affiliation for the study statistician, who appeared to not disclose his employment by Novartis.
When the stakes are high, the temptation to use every potential advantage to generate favorable study results is simply too great. Jeffrey Drazen has asked us to "Believe the Data" – I think the onus is on those who generate the data to earn our trust.
"Retraction—Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality study"