DOJ Launches Probe Over Questionable Brilinta Clinical Trials

  • Written by: Irvin Jackson

Pharmaceutical manufacturer AstraZeneca faces an investigation into its conduct regarding clinical trials for the blood thinner Brilinta, following accusations that the company downplayed or outright hid data on possible heart problems.  

The federal probe was announced by AstraZeneca in a third-quarter earnings report (PDF), indicating that the U.S. Justice Department (DOJ) has requested documents and information on a late-stage Brilinta clinical trial known as PLATO.

The announcement did not say why the probe was being launched. However, the investigation comes after a report in August in the International Journal of Cardiology, titled “Inactivations, deletions, non-adjudications, and downgrades of clinical endpoints on ticagrelor: Serious concerns over the reliability of the PLATO trial.” Ticagrelor is the active pharmaceutical ingredient in Brilinta.

According to the August report, which looked at data from an FDA review, the PLATO trial has a number of irregularities that raise suspicions about whether AstraZeneca manipulated data to make Brilinta appear safer than the results actually suggested. Among those irregularities was, for example, the fact that an independent review of the data found that 46% of all primary endpoint events favoring Brilinta came from just two countries, Poland and Hungary, despite the participation of subjects from numerous other countries. The review also found that heart attacks linked to Brilinta were under-reported in the clinical trial’s findings.

“[A]n estimated 23 definite or possible cardiovascular events or deaths on ticagrelor were either not submitted for adjudication, inactivated, deleted or were downgraded to “softer” endpoints,” the researchers found. The PLATO study compared Brilinta to its competitor, Plavix, and found signs that data on Plavix problems was reported more harshly and more often in the clinical trial than when the same problems occurred with Brilinta test subjects.

Just last month a study was presented at the European Society of Cardiology, where researchers from the Netherlands warned that a significant number of patients are dropping the drug due to side effects of Brilinta, which include breathlessness and other health problems.

Brilinta (ticagrelor) is a type of blood thinner known as a platelet aggregation inhibitor. It was developed by AstraZeneca and approved by the FDA in July 2011. It carries a black box warning for bleeding risks, similar to that of other blood thinners.

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  1. diane Reply

    I have a cousin hospital gave her brilinta one day 2 pills. She is now on permanent oxygen, steroids and has gone down hill since Dec 3, 2014. Now in a nursing home. Never told the side effects.

  2. Martha Reply

    Well, I’ve been on Brilinta for a little over three months now, and was just released from the hospital with severe anemia due to acute bleeding (menstrual), low blood pressure (90/46), and low heart rate. I was told this drug was “safer and more effective” than Plavix or aspirin, but neither of those sent me to the hospital thinking I was having another heart attack. After doing a bit of research, I’ve found out that I probably never should have been prescribed this drug in the first place.

  3. Jean m Reply

    Took drug for 6 months after a l artey stint surgery. No damage was done to heart due to light attack. Drug made me unable to walk across room without extreme shortness of breath and excruiting chest pains,. test of lungs show COPD which I did not have before..I have never smoked nor drank alcohol and I am 25 lbs overweight. Now Dr. says my heart is skipping a beat.

    This is a killer drug. Think aspiran is safer.

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