HOUSE COMMITTEE REQUESTS MORE INFORMATION FOR KETEK INVESTIGATION

Members of the House Committee on Energy and Commerce requested more information from the FDA regarding its approval of the antibiotic Ketek following a subcommittee hearing on the agency's drug approval process.

Representatives sent a letter to HHS Secretary Mike Leavitt asking for data from the planning and review of a controversial study on Ketek's safety known as Study 3014. Agency critics, including Sen. Chuck Grassley (R-Iowa), have accused the FDA of intentionally misleading an advisory committee reviewing Ketek's safety.

At a Subcommittee on Oversight and Investigations hearing last week, clinical research associate Ann Marie Cisneros testified that sanofi-aventis, which manufactures Ketek, knew about fraud committed in Study 3014.

The study's investigator, Anne Kirkman-Campbell, is currently serving a 57-month prison sentence for fraud associated with the study, Cisneros said. Kirkman-Campbell enrolled patients in the study on days when the office was closed, enrolled her entire staff in the study and blatantly forged consent documents, according to Cisneros.

When the FDA audited the site, a sanofi-aventis project manager coached Kirkman-Campbell on how to explain away allegations of improper conduct, Cisneros said. Sanofi-aventis has said it was not aware any fraud was being committed, but Cisneros testified that could not have been true.

The committee members requested all communications between independent contractors, the FDA and sanofi-aventis regarding Study 3014. They also requested records of FDA investigations relating to the study and a list of all people who worked on the review or investigations of Study 3014 in any respect.

( http://www.fdanews.com/did/6_37/ )