AstraZeneca is under investigation for manipulating clinical trial data on Brilinta (ticagrelol), a blood-thinning medication, raising concern about serious side effects like bleeding, heart attack, stroke, and death.
What is Brilinta?
Brilinta (ticagrelor) is a prescription blood-thinning medication for people who have had a recent heart attack or severe chest pain (unstable angina) due to a blood clot clogging an artery. It helps lower the chances of another heart attack, stroke, or death. It works by preventing platelets (small cells in the blood) from sticking together and forming a clot.
Brilinta Side Effects
Brilinta has been linked to the following severe side effects:
- Heart attack
- Sudden death
- Cardiovascular events
Justice Department Investigates Data-Manipulation in PLATO Study
In October 2013, the U.S. Department of Justice began investigating allegations of data-tampering in the PLATO clinical trial, an 18,000-patient study that AstraZeneca completed in 2009 and used to gain approval for Brilinta in July 2011.
The PLATO study compared Brilinta to its major competitor, Plavix (clopidogel), a similar blood-thinning drug. Overall, Brilinta plus aspirin was more effective at preventing heart attack, stroke, or death compared to Plavix plus aspirin.
However, in August 2013, FDA medical reviewers published a concerning critique of the PLATO study, pointing out a list of irregularities that suggest AstraZeneca may have manipulated data to make Brilinta appear safer than Plavix.
“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).”
Other examples of suspicious data:
- Patients in the PLATO trial who were monitored by AstraZeneca were reported as having more benefits from Brilinta than those monitored by an independent organization.
- 21% of all subjects came from Poland and Hungary — more than double the United States and Canada combined — and 46% of all favorable outcomes for Brilinta came from Poland and Hungary
- Significantly more heart attacks and hospitalization events were counted against Plavix, but similar events were not counted against Brilinta.
- Patients could easily tell whether they were getting the “dummy” Plavix by simply breaking open the tablet.
In August 2014, the Justice Department closed its probe of the PLATO trial without taking any action. No further action is planned by U.S. authorities.
Lack of Reversal Agent
The most common serious side effect of Brilinta is major bleeding, but in an emergency, it may be difficult or impossible to stop bleeding because Brilinta has no reversal agent. In November 2014, Reuters reported that AztraZeneca was developing an antibody treatment to reverse the blood-thinning effects of Brilinta.