One of the US Food and Drug Administration’s most important jobs is to provide the public with clear information about drug safety. Representative Joe Barton’s (R-TX) recent letter to the US Government Accountability Office (GAO) raises questions about whether FDA is telling us everything it knows.
Barton asked GAO to review FDA’s handling of the contaminated-heparin problems of 2007 and 2008. In his letter, he notes that FDA’s statements to the media in July 2008 indicate that the agency had “conclusively linked” deaths of three patients infused with heparin to oversulfated chondroitin sulfate found in specific lots of the drug manufactured by Baxter Healthcare (Deerfield, IL). Yet when Barton requested information, the agency told him in October 2008 that it was merely “possible” that heparin caused two of the deaths and that it could not assess whether heparin caused the third death.
Baxter’s own investigation concluded that it was unlikely that heparin had caused any of the three deaths. But FDA did not interview Baxter to get more information about the deaths, according to Barton’s letter.
Which way is up? Are we to believe FDA’s public statements or those the agency made to Barton? Why didn’t FDA seek more information from Baxter? Without clear and consistent statements from FDA, we can’t be sure how to use drugs safely.