Blockbuster Anticlotting Drug Approved on Flawed Studies
- Ticagrelor, a blockbuster anticlotting drug, was approved despite FDA scientists warning it looked less safe and effective than older, cheaper alternatives like clopidogrel
- The landmark PLATO trial used to secure approval showed U.S. patients had worse outcomes on ticagrelor, yet those results were overridden by FDA leadership
- Investigations revealed serious problems with the trial, including altered death records, missing data, and inconsistent monitoring that favored ticagrelor
- Follow-up platelet studies were also misreported, with non-significant results published as significant and some listed authors denying participation
- Knowing these flaws allows you to ask about proven alternatives, reduce your personal heart risk through lifestyle, and avoid dependence on drugs pushed forward with weak, flawed evidence
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