Re: Rivaroxaban: can we trust the evidence?
We at the Project On Government Oversight have been writing about this issue in the United States and applaud The BMJ for drawing attention to it.
The situation The BMJ describes poses a test of the system. Having employed the suspect devices in the Xarelto trial, can the people who conducted that trial be relied upon to review their own work objectively? Having apparently overlooked the problem in their original vetting of the drug for patients with atrial fibrillation, can the regulators be counted on to conduct thorough and impartial investigations now?
As we reported in November, the brand of blood-testing device used in the Xarelto trial was the subject of two FDA warning letters before the trial began. And, as we’ve reported, one of the co-chairmen of ROCKET AF’s executive committee—the group responsible for designing the trial—is today deputy commissioner of the FDA and President Obama’s nominee to head the agency.
A footnote: Though the FDA issued a recall notice in December 2014, the recall did not require that the systems be withdrawn from the market. They remain in use. The manufacturer “is working diligently to develop a software upgrade” for the devices to “address the potential for inaccuracies,” a spokeswoman for the company told us in November.
For more coverage of this subject, see “Drug Problems: Duke Reassessing Data From Trial Led By FDA Nominee” and links to related articles at this URL:
Project On Government Oversight
Competing interests: I've written about this topic and continue to cover it as a journalist for the Project On Government Oversight (www.pogo.org).