AstraZeneca’s anti-clotting medication Brilinta has been linked to life-threatening side effects like bleeding, heart attack, stroke, and death. Investigators are concerned that these risks may have been downplayed in clinical trials.
Did AstraZeneca Manipulate Trial Data?
In July 2011, the FDA approved Brilinta for patients with a history of heart attack or acute coronary syndrome. The approval was based on data from the 18,000-patient PLATO clinical trial, a study that showed lower rates of heart attack, stroke, and death for patients on Brilinta compared to Plavix.
In October 2013, FDA investigators published a report describing “multiple serious deficiencies” in adverse event reporting in the PLATO trial. For example:
“An estimated 23 definite or possible cardiovascular events or deaths on [Brilinta] were either not submitted for adjudication, inactivated, deleted or were downgraded to “softer” endpoints (this was not shown in the FDA review).”
Twice as many patients in the study came from Poland and Hungary than the United States and Canada combined. Nearly half of the patients who had good outcomes came from Poland or Hungary. In the part of the study based on the United States, results were opposite — Brilinta patients were 27% more likely to experience heart attack, stroke, or vascular death.
The FDA blamed the irregularity on some U.S. patients being given doses of aspirin above 100-mg, which could decrease the effectiveness of Brilinta. The label now carries a “Black Box” warning about this interaction.
According to the Wall Street Journal, a federal lawsuit was also filed against AstraZeneca by Dr. Victor Serebruany, a medical professor at Johns Hopkins Hospital who warned that data from the study may have been manipulated. The U.S. Department of Justice (DOJ) also opened an investigation, but ended the probe nine months later without taking any action.