December 1, 2015 — Concerns have been raised about the integrity of data from the ROCKET-AF clinical trial, which compared Xarelto to warfarin, after investigators found that the study relied on defective device to calibrate warfarin usage.
The Alere INRatio and INRatio2 PT/INR Monitor System was subject to a Class 1 recall one year ago because it could provide INR results (blood-clotting rates) that were significantly too low. The problem could result in patients being given more warfarin than necessary, which would increase their risk of bleeding and death.
The ROCKET-AF trial concluded that Xarelto and warfarin caused similar rates of bleeding. However, faulty INR blood-testing devices could have skewed the results in favor of Xarelto.
Problems with the INRatio’s erroneous readings are nothing new — the FDA issued warning letters about the issues in 2005 and 2006. Even so, the devices were used in the ROCKET-AF trial when it opened enrollment in 2006.
The results of the study were published in 2011 and Xarelto was approved soon afterward, over the objections of some FDA reviewers who said warfarin was not administered in an optimal way.
The Project on Government Oversight reports that researchers at Duke University are re-assessing the data to determine whether faulty INR results influenced the study. The European Medicines Agency is also investigating, according to MedPage Today.
The co-chairman of the ROCKET-AF trial, Dr. Robert Califf, was responsible for designing and overseeing the trial. He is President Obama’s nominee to be the next FDA Commissioner, but some say he is too close to the industry he is being called on to regulate. Dr. Califf worked as a consultant for drug-makers and ran a $200 million clinical research institute at Duke University that received most of its funding from the pharmaceutical industry, according to the New York Times.
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