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Ketek Probe Raises Questions About FDA Head

Mar 10, 2008 | Parker Waichman Alonso LLP

A congressional Ketek probe has taken a stunning turn, as it now  appears that the head of the Food & Drug Administration (FDA) may have committed perjury when he gave written testimony to a committee investigating the agency's approval of the defective drug, Ketek.

Ketek was approved by the FDA in 2004 to treat respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia.   Soon after its approval however, the FDA began to receive reports that Ketek was causing liver damage in some patients.   This past February, the FDA added black box warnings about liver damage to the Ketek label.  In total, the FDA had reports of at least 53 cases of liver damage linked to Ketek.  At least five of those cases were fatal, and one required a liver transplant.  The FDA also withdrew Ketek’s approval to treat sinusitis and bronchitis.

In February,  the subcommittee issued subpoenas to Health and Human Services (HHS) Secretary Michael Leavitt, asking him to produce unredacted records prepared for the FDA commissioner’s appearance at a March 2007 hearing on Ketek. Leavitt’s department oversees the FDA.  The committee also approved subpoenas for two current FDA investigators, one former FDA investigator and a former employee of a company that monitored the fraudulent Ketek clinical trials.  The subpoenas were necessary because the Bush Administration had refused to release the documents or allow any of the officials to testify.  At first Leavitt refused to turn over the documents, but finally gave in when he was threatened with Contempt of Congress charges.

Those documents in question deal with FDA Commissioner Andrew von Eschenbach's written testimony regarding events surrounding the Ketek drug approval. According to an article on the American Chronicle website, the committee subsequently learned from an FDA insider and those familiar with the approval that the testimony was not truthful.

According to American Chronicle  "Von Eschenbach is a cancer-industry insider who took the job at the FDA so he could get quick approval of new biotech drugs while using humans for cruel experiments in the name of "progress." His nomination as permanent head of the FDA took place during the 2006 lame duck session of Congress and was rubber stamped by Big Pharma friendly Senators."

During Von Eschenbach's confirmation hearings, Senator Charles Grassley, a Republican, criticized the Bush Administration on the floor of the Senate for naming Von Eshenbach to head the FDA.   "People ought to be ashamed of saying Dr. Andrew von Eschenbach has done a superb job in the position he is currently occupying [acting head of the FDA].…That is an insult….In my interactions with the Department of Health and Human Services and the FDA these last 8 months, I have seen a complete and utter disrespect for congressional authority and hence the law.… This body [the Senate] should not walk hand in hand with the executive branch and sit idly by as instances of abuse and fraud continue to endanger the health and safety of American people," Grassley said.