House Energy and Commerce Subcommittee on Oversight and Investigations hold hearing today on “Ketek Clinical Study Fraud: What did Aventis know?”

Sanofi-Aventis, a medical research company, is being charged with knowingly engaging in clinical study fraud in a large Ketek study called Study 3014 that was headed by Dr. Anne Kirkman-Campbell, who is now serving prison time. Ketek is an antibiotic that was originally intended to treat bronchitis, sinusitis and pneumonia, but was only cleared to be prescribed for community-based pneumonia.

Ms. Ann Marie Cisneros, Former Senior Clinical Research Associate at PPD, Inc., testified that Aventis knew that there was something wrong with Dr. Kirkman-Campbell’s findings and did nothing. Cisneros states that a number of “red flags” were apparent, including discrepancies with every informed consent, one consent that was “blatantly forged,” and the fact that she enrolled her entire staff in the study. Cisneros summed up her view of Dr. Kirkman-Campbell by stating that she only seemed interested in getting more business from Aventis as an investigator to conduct more and more clinical tests, receiving $400 per patient tested. One point of interest was the fact that even when Cisneros reported her findings to Copernicus, an Independent Review Board (IRB), she said that Copernicus “never did audit or blacklist the site, or report any irregularities to the FDA.”

Following Ms. Cisneros, Special Agent Douglas Loveland, Office of Criminal Investigation of the FDA, described Dr. Kirkland-Campbell as sloppy, and the fact that Aventis was willing to submit “sloppy data” reflected poorly on the company. Loveland stated what actually made it difficult to bring Aventis to court was the fact that the FDA wants reliable data, and “sloppy or fraudulent data is not reliable.” Aventis used sloppy data so that they would not have to throw up a “fraud flag,” which would make the fraud more easily detectable. Aventis proceeded with releasing the inaccurate data even though they themselves had written up 11 different sites where they believed erroneous studies took place.