Pharmaceutical manufacturer AstraZeneca faces an investigation into its conduct regarding clinical trials for the blood thinner Brilinta, following accusations that the company downplayed or outright hid data on possible heart problems.
The federal probe was announced by AstraZeneca in a third-quarter earnings report (PDF), indicating that the U.S. Justice Department (DOJ) has requested documents and information on a late-stage Brilinta clinical trial known as PLATO.
The announcement did not say why the probe was being launched. However, the investigation comes after a report in August in the International Journal of Cardiology, titled “Inactivations, deletions, non-adjudications, and downgrades of clinical endpoints on ticagrelor: Serious concerns over the reliability of the PLATO trial.” Ticagrelor is the active pharmaceutical ingredient in Brilinta.
According to the August report, which looked at data from an FDA review, the PLATO trial has a number of irregularities that raise suspicions about whether AstraZeneca manipulated data to make Brilinta appear safer than the results actually suggested. Among those irregularities was, for example, the fact that an independent review of the data found that 46% of all primary endpoint events favoring Brilinta came from just two countries, Poland and Hungary, despite the participation of subjects from numerous other countries. The review also found that heart attacks linked to Brilinta were under-reported in the clinical trial’s findings.
“[A]n estimated 23 definite or possible cardiovascular events or deaths on ticagrelor were either not submitted for adjudication, inactivated, deleted or were downgraded to “softer” endpoints,” the researchers found. The PLATO study compared Brilinta to its competitor, Plavix, and found signs that data on Plavix problems was reported more harshly and more often in the clinical trial than when the same problems occurred with Brilinta test subjects.
Just last month a study was presented at the European Society of Cardiology, where researchers from the Netherlands warned that a significant number of patients are dropping the drug due to side effects of Brilinta, which include breathlessness and other health problems.
Brilinta (ticagrelor) is a type of blood thinner known as a platelet aggregation inhibitor. It was developed by AstraZeneca and approved by the FDA in July 2011. It carries a black box warning for bleeding risks, similar to that of other blood thinners.