Not So Brilliant? Feds Probe AstraZeneca Over Brilinta Trial Data

Six months after a medical journal raised troubling questions about the reliability of a key study that was used to win approval for its Brilinta bloodthinner, AstraZeneca (AZN) says that the US Department of Justice has recently opened an inquiry into the trial, according to a filing with the US Securities and Exchange Commission. The disclosure was made in the most recent earnings report that was released today (see page 28). An analysis last April in The International Journal of Cardiology found a host of disturbing issues with the so-called Plato trial. Nearly three years ago, the FDA questioned aspects of the study and, initially, refused to approve Brilinta and sought additional analysis, although approval was granted in July 2011. To what extent the authorities are probing clinical data is unclear for the moment, but the analysis found several problems. For instance, significantly more cardiac events submitted for Plavix counted in the primary analysis as a myocardial infarction compared to those submitted for Brilinta. The Plato trial compared the use of both bloodthinners along with aspirin. Other findings: an estimated 23 definite or possible cardiovascular events or deaths on Brilinta were either not submitted for adjudication, inactivated, deleted or were downgraded to softer endpoints. Significantly more Brilinta subjects hospitalized after an index event or hospitalization were not being reported as having a primary event compared to Plavix. And 46 percent of th...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs