European Regulators Investigating Clinical Trial of Drug Led By Obama FDA Nominee

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 additional concerns of his own, the Project on Government Oversight reports.

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.

More here