President Obama’s nominee to head the Food and Drug Administration, Robert Califf, has been hailed as an expert on the clinical testing of prescription drugs, but he helped lead a clinical trial that was sharply criticized by FDA reviewers and some outside advisors to the agency.
The clinical trial of the blood thinner Xarelto was biased in favor of the experimental drug, an FDA staff review found.
A “lack of care” in the trial’s design and execution might have led to avoidable strokes among test subjects, a senior FDA official wrote.
The FDA approved Xarelto in 2011 over the objections of the primary FDA scientists assigned to study its safety and effectiveness. The report by the reviewers argued that patients could be “at greater risk of harm from stroke and/or bleeding” if they took Xarelto than if they were treated skillfully with warfarin, a blood thinner that has been on the market since the 1950s.