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Independent investigations revealed data integrity issues in the PLATO trial for ticagrelor, highlighting regulatory reforms may be necessary to protect public trust.
Ticagrelor, marketed in Mexico as Brilinta®, was approved based on the PLATO trial, despite mounting international concerns over data integrity, authorial inconsistencies, and adjudication bias. Independent investigations by The British Medical Journal (BMJ) revealed manipulated endpoints, missing platelet data, and geographic discrepancies favoring AstraZeneca. In Mexico, the cause-of-death reports for two patients were allegedly altered, potentially biasing the efficacy outcomes in favor of the drug. The drug’s high cost raises ethical and economic concerns compared to generic clopidogrel. We urge regulatory reforms in Latin America to ensure transparent, evidence-based approval processes, safeguard public trust, and protect patients from scientifically questionable therapies.
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Castañeda‐Hernández et al. (2025) studied this question.
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