President Obama's nominee to head the FDA helped "design and oversee" an approved drug whose clinical trial is now under investigation by European regulators.
Robert Califf, the deputy commissioner of the FDA, co-chaired the executive committee of the Xarelto clinical trial while at the Duke Institute for Clinical Research. Xarelto, a drug used to thin the blood in heart patients, could put patients "at greater risk of harm from stroke and/or bleeding."
The drug’s trial came under criticism but was ultimately approved in 2011 despite concerns from some scientists. The official who issued the FDA’s approval of the drug expressed additionally concerns of his own, the Project on Government Oversight reports.
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.
The official who issued the FDA’s decision to approve the drug expressed a series of misgivings about it.
"The decision was made difficult by the limitations in the design and conduct" of the clinical trial, FDA Deputy Division Director Stephen M. Grant said in a November 2011 memo explaining the agency’s reasoning.
"Although ultimately coming to a different conclusion than some of the reviewers, both the Division Director and the Deputy shared the team’s concerns," Grant wrote.
AllGov.org adds more detailing the European investigation:
The clinical trial relied on blood testing devices that were the subject of two FDA warning letters before the trial began and an FDA recall notice after the trial ended, according to the Project on Government Oversight (POGO). Certain devices in the INRatio product line, the warning notice read, could deliver false test results and that use of those devices may "cause severe or life-threatening injuries, including death."
The EMA has said it "is currently investigating whether the data generated from the INRatio device could have had any impact on the trial results and the extent of this impact, if applicable."
An FDA staff review of the trial showed that it was biased in favor of approving Xarelto, POGO reported last month. Patients using Xarelto were said to be "at greater risk of harm from stroke and/or bleeding" than if they were treated with warfarin, a blood thinner that has been on the market since the 1950s.
More than 2,000 lawsuits have been filed around the United States alleging uncontrollable bleeding from patients taking Xarelto which in some cases led to death.
Xarelto is manufactured by Bayer and marketed in the United States by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Califf was a paid consultant for numerous companies while at the Duke Institute for Clinical Research, including Johnson & Johnson. In 2012, Califf received an $87,500 payment from the company.