Did Alere INRatio Alter Xarelto Trial Results?
In fall of 2015, Bayer and Johnson and Johnson notified the FDA that the device used in the clinical trials for their drug Xarelto (a blood thinner and direct competitor to warfarin) was recalled for giving inaccurate results. The device in question? The Alere INRatio.
The clinical trial for the blockbuster blood thinner Xarelto (called the Rocket AF) directly compared bleeding events in patients taking Xarelto to those taking warfarin. Because the Alere INRatio has now been discovered to give inaccurate results, some doctors and even the FDA are taking a closer look into the clinical trials for Xarelto to see if the INRatio skewed the results.
In February of 2016, the Duke Clinical Research Institute and the European Medicines Agency both published their own analyses concluding that the Alere INRatio did not affect the Xarelto trials’ outcome. Duke, who oversaw the Rocket AF clinical trials, performed a study after they became aware that the Alere INRatio was recalled, and ultimately ended up with very similar results to the Rocket AF trials. Because of their similar results, they concluded that the Alere INRatio did not skew the results in Xarelto’s favor.
Although both studies have found very similar results to the Rocket AF clinical trials, the FDA is still taking a closer look into the issue, and many doctors are still skeptical. The current Xarelto litigation has brought to light allegations that there were emails sent during the Rocket AF trials where doctors were questioning whether or not the Alere INRatio was functioning properly.
Only time will tell whether or not the Alere INRatio had a significant effect on the results on the Rocket AF clinical trials. Further investigation by the FDA and independent sources (other than those who oversaw the original Rocket AF trials) may reveal that the Alere INRatio had a clinically significant effect on the trials. If the Alere INRatio did have a clinically significant effect on the Rocket AF trials, it could ultimately have led to FDA approval of Xarelto, which is now the subject of extensive litigation with over 2,000 pending cases against its manufacturers.