March 9, 2008

A congressional probe into the safety of Ketek has taken a stunning turn, as it now appears that the head of the Food & Drug Administration (FDA), Andrew von Eschenbach, 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.   In February 2007, the FDA added a black box warning about liver damage to the Ketek label.  At that time, the FDA had reports of at least 54 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.

Congress became involved in the investigation of Ketek after it was discovered that a clinical trial involving the drug was forged by a weight loss clinic in Gadsden, Alabama. The physician in charge of the clinical trial, Dr. Maria Anne Kirkman-Campbell, is now serving five years in prison. Now, Congress seeks to establish what, if anything, Sanofi-Aventis and the FDA knew.

On January 25, 2008, John Dingell and Bart Stupak of the House Oversight and Investigations Subcommittee sent a memorandum stating they intended to subpoena FDA investigators, a private contractor, and various FDA records, which they followed through on several days later.

On February 12, 2008, the House committee held hearings on the matter. Although the FDA admitted that it knew there were “serious protocol violations and regulatory noncompliance by multiple clinical investigators,” the agency says it had no knowledge of whether these problems were ever fixed before approving the drug. However, the FDA was not forthcoming about information that may indicate a von Eschenbach cover-up.

In March 2008, von Eschenbach provided written testimony to the committee on events surrounding the Ketek drug approval. An FDA insider subsequently told the committee that the testimony was not truthful. To learn why it was lied to, the committee recently subpoenaed the FDA records regarding the preparation of this testimony.

On February 12, 2008, the committee was told by the FDA’s parent agency, the Health and Human Services Department, that these documents would not be provided because “The department has serious concerns about providing the kind of materials the committee has subpoenaed…such highly confidential and deliberative materials used to prepare witnesses testifying before Congress risks chilling the open exchange of views that is essential to the effective conduct of agency business.” Now, Congress seems to have hit a brick wall.

Published November 17, 2011 by