A recent investigation by The BMJ raises significant concerns about data integrity in the PLATO trial, which supported the FDA approval of ticagrelor, a drug costing the US over $750 million annually. Despite demonstrating potential benefits in reducing vascular deaths, the trial’s findings, published in 2009, showed inconsistencies, particularly among US patients, leading to skepticism from experts, including FDA medical officer Thomas Marciniak, who criticized the trial’s submission for approval. Following concerns about the reliability of the data, experts like Victor Serebruany and Eric Bates have called for a reexamination of ticagrelor’s clinical guidelines. Moreover, discrepancies in patient death reporting and trial oversight have surfaced, with The BMJ revealing that the authors of a key statistical paper lacked impartiality due to a connection with AstraZeneca. The investigation suggests that the monitoring systems may have influenced outcomes unfavorably at sites overseen by third-party groups. AstraZeneca has declined further comments on the findings, while the NEJM acknowledged reporting gaps without commitment to amend them. Serebruany advocates for renewed involvement from the US Department of Justice to further investigate the trial’s integrity for the sake of transparency and public safety.
