SciTech Daily: In a follow-up investigation into the multibillion-dollar drug ticagrelor, The BMJ has identified new concerns.
For more than a decade, the multibillion dollar drug ticagrelor (Brilinta in the US and Brilique in Europe) has been recommended in the treatment of patients with acute coronary syndrome. As generic versions of the antiplatelet drug prepare to launch this year, The BMJ has investigated the evidence underpinning the drug’s approval and continued use. In our first story we revealed serious data integrity problems in the PLATO study, the 18 000 patient randomised trial that brought ticagrelor to market.1
The BMJ now turns its attention to two key supporting AstraZeneca studies that convinced doctors of ticagrelor’s ability to rapidly and consistently inhibit platelets—critical for managing patients following percutaneous coronary intervention. Our investigation was based on interviews with trial investigators and platelet experts and access to the underlying trial data submitted to regulators, as well as readouts from laboratory equipment used in the studies. We found evidence that the trials were inaccurately reported. In one instance AstraZeneca’s trial failed to show statistical significance, but was published in a leading cardiology journal as significant. Extraordinarily, most investigators, including the principal investigator and the drug company, were unreachable or declined to be interviewed. The findings raise even deeper questions over the approval and decade long use of the drug.