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Ashcraft & Gerel
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Congressional Investigation of Possible Clinical Study Fraud Involving Ketek
The United States Congress is investigating possible clinical
study fraud involving a key study of Ketek. On February 12, 2008, witnesses testified at a Congressional hearing concerning the approval of Ketek, and more specifically concerning Study 3014, the clinical study that was found to have results based on potentially fraudulent and false data.
The government web page reporting the Congressional investigation can be viewed
by clicking
here. A video of the hearing can be viewed by clicking
here.
The witnesses, in front of the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations, included among others:
Ann Marie Cisneros, who served as a senior clinical research assistant with Pharmaceutical Product Development Inc. ("PPD") in Wilmington, N.C. PPD was the contract research organization which was hired by Sanofi-Aventis to monitor Study 3014. Ms. Cisneros was tasked with monitoring the site headed by Dr. Anne Kirkman-Campbell, of Gadsden, Ala., one of 1,800 private physicians involved in the actual testing that made up Study 3014. Dr. Kirkman-Campbell later pleaded guilty to mail fraud in connection with her participation in Study 3014, and she was sentenced to four years in prison.
Ms. Sharon Hill Price, CEO and chairwoman of the board for the Copernicus Group Institutional Review Board ("IRB"). IRBs are tasked with general oversight of patient safety in clinical trials.
Robert West, special agent with FDA's Office of Criminal Investigations.
Paul Herbert Chew, president, U.S. Research and Development Division of Sanofi-Aventis.
Among the highlights of the various testimony, Ms. Cisneros testified that she noticed some medical consent forms were initialed by Kirkman-Campbell rather than the patients, that the doctor's staff and family were enrolled in the 407-patient study, and medical records had been altered. Ms. Cisneros also stated that she had relayed those concerns to the Copernicus Group, which sets the protocols for trials, but that no action was taken. Ms. Hill Price, Copernicus's CEO, testified in response that she never received the message.
Mr. West testified that in July 2003, after the Dr. Kirkman-Campbell allegations, he recommended to his superiors that the FDA launch an investigation of Sanofi-Aventis' role in the clinical study, but his request was ignored.
Mr. Herbert Chew testified that his company was not able to confirm fraud in the clinical trials. He added that the company has since changed training and procedures.
Sen. Charles Grassley, R-Iowa, who chaired the House committee before he was elected to the Senate, testified that the investigation into Ketek has been marked by foot-dragging. He stated that it took a year for the FDA to respond to his questions about Ketek. In fact, Rep. John Dingell (D-Mich), chairman of the committee in charge of the investigation, stated he would consider holding Health and Human Services (HHS) Secretary Michael Leavitt in contempt after
he refused to turn over the FDA briefing documents subpoenaed by the committee as part of its investigation. The documents were used to prepare FDA Commissioner Andrew von Eschenbach for his appearance before lawmakers last year.
The Committee noted that it would continue to pursue all the documents subpoenaed in relation to this matter, and if further hearings on this issue are necessary, they will certainly occur.
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