Advocacy group Public Citizen is calling on the FDA to investigate the use of Alere’s INRatio blood testing device during a clinical trial supporting approval of Bayer’s blood thinner Xarelto, claiming that false readings by the device could have skewed trial results in favor of the drug.
From 2006 to 2010, the Rocket AF trial compared Xarelto (rivaroxaban) with warfarin for prevention of stroke and systemic embolism in patients with atrial fibrillation.
In a letter sent to the FDA last week, Public Citizen says its analysis of the FDA’s Manufacturer and User Facility Device Experience database shows 9,469 malfunction reports and 1,445 injury reports from 2002 through November of this year with INRatio devices.
However, last week, the Rocket AF Clinical Trial Executive Committee released its secondary analysis of the Phase 3 trial, claiming the findings are consistent with the results from the original trial and do not alter the conclusions that rivaroxaban is a reasonable alternative to warfarin for preventing stroke and systemic embolism with less intracranial hemorrhage and fatal bleeding.
Public Citizen also raises questions on FDA Commissioner nominee Robert Califf’s role in choosing the measuring device to interpret the study. At the time, Califf was co-chairman of the industry steering committee advising Johnson & Johnson on the study.
“Hundreds of reports of injuries or malfunctions with the INRatio device occurred before this trial started,” says Sidney Wolfe, co-founder and senior adviser of Public Citizen’s Health Research Group.
“The device was known to give faulty readings and injure patients. Why did Dr. Califf and the steering committee that he co-chaired agree to use it in the trial?” Wolfe adds.
FDA spokeswoman Katie Conover did not respond to a request for comment on Public Citizen’s call to investigate Califf’s role in choosing the device for the study.
However, she tells IDDM that Califf is recused from the matter, and that the agency is reviewing relevant trial data.
Manesh Patel, a member of the Rocket AF Executive Committee, told IDDM that the device was chosen for several technical reasons, and because it had FDA and CE Mark approval in the U.S., Europe and other potential countries.
He maintains that during the planning and execution of the trial, the executive committee was not aware of any issues with the device.