FDA Nominee Oversaw Questionable Clinical Trial for Blood Thinner Xarelto

The nominee to head the Food and Drug Administration, the agency that oversees all prescription drugs marketed in the U.S., led a clinical trial that was sharply criticized as biased in favor of the experimental blood thinner Xarelto, the Project On Government Oversight (POGO) reported today.

Robert Califf, President Obama’s FDA nominee, co-chaired the executive committee of the Xarelto clinical trial. 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. Their review 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, POGO reported

As FDA commissioner, Califf will hold considerable sway over decisions that affect the interests of the drug industry and the health and safety of the public.

“Dr. Califf’s handling of the Xarelto trial raises concerns about his judgement in overseeing the pharmaceutical industry.” POGO Executive Director Danielle Brian said. “As senators consider Dr. Califf's confirmation to run the FDA, they should ask tough questions about the Xarelto clinical trial.”

Like the story of a competing drug, Pradaxa, which was the subject of POGO report, the FDA’s handling of Xarelto illustrates how low the government has set the bar for drug approval, how manufacturer-sponsored clinical trials that serve as the basis for FDA decisions can be of questionable value, and why the words “FDA approved” should not necessarily inspire confidence in prescription drugs.

Follow the link to read POGO’s article on Califf.