British drug maker AstraZeneca in under investigation by the U.S. Department of Justice over a major clinical trial involved in the approval of its heart drug Brilinta (ticagrelor).
AstraZeneca said on Thursday that it had received a civil investigative demand from the Department of Justice (DOJ) for documents and information about the so-called PLATO study (PLATelet Inhibition and Clinical Outcomes). AstraZeneca chief executive Pascal Soriot said the company would cooperate with the investigation. Soirot said he was “very confident” in the findings of the clinical trial, because “a strong academic group” had overseen the trial, 4-Traders.com reports.
The company did not disclose the nature of the investigation, and DOJ spokesman Peter Carr had no immediate comment on the case, according to 4-Traders. The PLATO study, which included 18,000 patients was first reported at a medical meeting in 2009 and then formed the basis of drug approval applications in the United States and other countries. Brilinta, a blood thinner, received Food and Drug Administration (FDA) approval in July 2011.
Aspects of the PLATO study have been criticized, 4-Traders reports. Twenty-one percent of the subjects were recruited from Poland and Hungary, more than double the number for the United States and Canada combined. Researchers James DiNicolantonio of Ithaca, New York, and Ales Tomek of Charles University in Prague raised questions about the conduct of the study in a recent article in the International Journal of Cardiology. Their analysis showed that patients in the trial monitored by AstraZeneca were reported to experience more beneficial effects from Brilinta than those monitored by an independent clinical research organization, according to 4-Traders. Lars Wallentin of Uppsala Clinical Research Center in Sweden, the principal investigator on PLATO, strongly disputes those conclusions. At the time of the drug’s approval, The New York Times reported that trial results were worse in the U.S. than in the rest of the world, for reasons that weren’t clear.
Brilinta was approved to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS), such as unstable angina or heart attack, which could result from reduced blood flow to the heart. Brilinta works by preventing the formation of new blood clots. Brilinta carries a boxed warning that aspirin doses above 100 milligrams per day decrease the effectiveness of the medication, and the drug carries the same boxed warning about bleeding risks that Plavix and other blood thinners carry.