February 14, 2007 The Pump Handle 0Comment

by Susan F. Wood 

Yesterday’s hearing (Feb 13, 2007) before the House Energy and Commerce Oversight and Investigations Subcommittee was amazing in several ways.  What struck me was the willingness of senior FDA physician-scientists (who have recently left FDA) to speak publicly about their concerns about the ignoring of safety and efficacy data quality when there is an apparent push for approval.  The specific product they were talking about is Ketek, an antibiotic that has had much written about it including on the Pumphandle.  The specific issues identified have to to with the use of non-inferiority studies to assess efficacy, significant safety concerns being overlooked when Ketek was approved for conditions such as sinusitus, and the reality of serious fraud during the safety trials that was not revealed to the advisory committee.

This hearing is worth viewing in it’s entirity (should be posted here soon), or if you have to shorten your viewing time watch the second panel, consisting ofDavid Ross, MD, PhD (a primary safety reviewer and safety team leader for Ketek), John Powers, MD,(lead medical officer for antimicrobial development and resistance initiatives) and Anne Marie Cisneros (research associate at the contract research organization that oversaw the safety study).

FDA and the company which manufactures Ketek (Sanofi Aventis) are expected to testify in future hearings, to give their views on these issues.  But, tellingly, FDA issued an announcement the day before the hearing, adding a black box warning to the label of Ketek, and removing two of the three indications for its use. 

Acting the day before a hearing is starting to be a pattern (similar to the announcement of probable approval of emergency contraception to go over-the-counter, which came out the day before Dr. Andrew von Eschenbach’s Senate confirmation hearing). 

These hearings apparently help to focus the agency’s mind to do what needs to be done, but this is not a good way for FDA decisions to be made.  There must be a better way forward.

Susan Wood is Research Professor at George Washington University School of Public Health and Health Services, where she is part of the Project on Scientific Knowledge and Public Policy (SKAPP).

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