House committee issues subpoenas in Ketek investigation

WASHINGTON Days after announcing that it was beginning to investigate current and former investigators for the Food and Drug Administration over the possibility of approving the antibiotic Ketek, even though they knew of possible health concerns, the House Energy and Commerce Committee has voted on issuing subpoenas to FDA officials and for agency documents.

The individuals subpoenaed are current FDA criminal investigators Robert West and Douglas Loveland, former investigator Robert Ekey and clinical research associate Ann Marie Cisneros, who testified before the subcommittee in February 2007 that the manufacturer, Sanofi-Aventis was aware of fraud committed in the Ketek clinical trial known as Study 3014.

The clinical investigator in that trial, Anne Kirkman-Campbell, was sentenced to 57 months in prison for fraud associated with the study. 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.

The documents to be subpoenaed include, but are not limited to, all communications among senior staff at the FDA, the agency’s Office of Legislative Affairs, the Health and Human Services Office of Legislative Affairs and Budget and the HHS Office of the General Counsel, “including communications from the FDA Office of Chief Counsel to Commissioner von Eschenbach and his senior staff.”