AstraZeneca's Brilinta Under Scrutiny: New Allegations Raise Questions About Trial Data Integrity

AstraZeneca's blood thinner Brilinta (ticagrelor) faces renewed controversy as fresh allegations emerge regarding the integrity of its clinical trial data. The British Medical Journal (BMJ) has uncovered discrepancies in multiple studies that supported the drug's initial approval, casting a shadow over its decade-long use in the pharmaceutical market.

Data Integrity Concerns Extend Beyond Pivotal Trial

Following the BMJ's December report on data integrity issues in the pivotal Phase 3 PLATO trial, an expanded investigation has revealed inaccuracies in two additional supporting studies. The Onset/Offset and Respond trials, which were instrumental in demonstrating Brilinta's platelet inhibition capabilities, are now under scrutiny.

Key findings from the BMJ's investigation include:

• Inaccurate reporting of primary endpoint data in the cardiovascular journal Circulation
• Elimination of over 60 platelet machine readings from FDA datasets
• Questionable competence of trial sites involved in the Onset/Offset study
• Missing patient baseline data and unusual platelet aggregation patterns

The BMJ report also highlights irregularities in study authorship, with one investigator omitted from the author list and another denying involvement in the trial.

AstraZeneca's Response and Market Impact

AstraZeneca has defended the integrity of the trials, stating they remain confident in the evidence supporting Brilinta. However, the company did not respond to the BMJ's request for comment during the investigation.

These allegations come at a critical time for Brilinta:

• The drug's patent exclusivity in the U.S. expired in May 2025
• Pediatric market exclusivity extends to November 2025
• Sales have declined from a peak of $1.6 billion in 2020 to $751 million in 2024

Implications for the Pharmaceutical Industry

The controversy surrounding Brilinta raises broader questions about data integrity in clinical trials and the approval process for new drugs. As the industry grapples with these issues, regulatory bodies may face increased pressure to enhance scrutiny of trial data and strengthen safeguards against potential manipulation.

The situation also underscores the challenges pharmaceutical companies face in maintaining trust and transparency, particularly as blockbuster drugs near the end of their patent protection periods.