What The Probe Into The Brilinta Trial May Mean For AstraZeneca

The drumbeat of investigations launched by this or that government agency into a big drugmaker is often shrugged off, at least by investors, who play wait-and-see since the outcome of such probes can amount to nothing. However, the news that the US Department of Justice is investigating a key trial for the Brilinta bloodthinner sold by AstraZeneca prompted a cautious response from one analyst. What are the feds looking at? As we wrote last week, the inquiry is focused on the PLATO trial, which was used to win FDA approval. There were no other details, but the disclosure came six months after a small group of researchers raised troubling questions about the reliability of the study in a medical journal article. The principal investigators quickly issued a staunch defense. The researchers wrote in The International Journal of Cardiology that an estimated 23 definite or possible cardiovascular events or deaths on Brilinta were either not submitted for adjudication, inactivated, deleted or downgraded to softer endpoints. More Brilinta subjects hospitalized after an index event or hospitalization were not reported having a primary event compared to Plavix. And 46 percent of the primary endpoints favoring Brilinta came from just two countries (back story with a link to the abstract). As Sanford Bernstein analyst Tim Anderson points out in an investor note, these are not new allegations, but perhaps investors have largely written off concerns about any lasting damage. “Many times,...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs