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Ketek Hearing Winners and Losers

Wednesday, February 13, 2008

After listening to the Feb. 12 hearing by the House Energy and Commerce’s Subcommittee on Oversight and Investigations probing study fraud and the antibiotic Ketek, one thing is clear: PPD, which monitored the study in question sponsored by Aventis (now Sanofi-Aventis), took the least hits from Congress. And it is also quite clear that many in Congress, including committee staff, don’t seem to understand much about the research process.

Outside of the FDA—which the committee would like to hold in contempt of Congress for failing to respond to a subpoena— taking the toughest criticism from the committee was Sharon Hill Price, founder and chief executive officer of Copernicus Group, the institutional review board (IRB) which oversaw the study.

Price, who admitted to being a bit nervous, was hammered by Michigan Democratic Rep. Bart Stupak, chairman of the oversight and investigations subcommittee, and House Energy and Commerce Committee Chairman John Dingell.

Stupak was upset that Copernicus didn’t provide in a timely fashion a call log of a phone call from Ann Marie Cisnernos, the former PPD study monitor and whistleblower, who reported the fraud that led to the conviction of Anne Kirkman-Campbell, a clinical investigator on Study 3014. Price told committee members she doesn’t recall talking to Cisneros.

Visibly frustrated with Price’s answers, Stupak at one point asked Price, “Why do you exist?” Presumably Stupak was referring to the IRB and not Price herself. Many of Stupak’s and Dingell’s questions showed a clear lack of understanding of clinical research. At one point Stupak was baffled at what “GCP” stood for. He was told Good Clinical Practices, the research standard. Ouch.  Dingell seemed lost when trying to figure out where in the research process an IRB figured in.

Besides Copernicus, it was evident from the hearing title “Ketek Clinical Study Fraud: What Did Aventis Know?” that Sanofi-Aventis would come under prolonged fire. And the company did.  FDA investigator Douglas Loveland called Aventis’ handling of the study a “catastrophic failure” and later “willful blindness on steroids.”

“The decision making process Aventis used to investigate these (fraud) problems was illogical and ineffective and it could have led them to come to the wrong conclusion,” Loveland said.

However, Loveland said it couldn’t be proven “beyond a reasonable doubt” that Aventis was aware of the fraud when the company submitted the study data on Ketek to the FDA. He added that believed the statute of limitations had expired on bringing charges against the company.

Still, Dr. Paul Herbert Chew, president of U.S. research and development for Sanofi-Aventis Pharmaceuticals, held up well under the committee’s glare. He was well versed on the study’s problems and what the company was doing to prevent similar frauds in the future. With all those charges flying, in an encouraging sign for contract research organizations, PPD came away pretty much unscathed.

Cisnernos didn’t really go after PPD. And, in a telling exchange, Stupak asked Chew how well PPD did monitoring the study.  Chew responded: “PPD did a good job.”

Fred Eshelman, chief executive officer of PPD, did take some revealing questions concerning how PPD selects investigators and whether it relies on FDA’s debarment list during that process. Committee members were incensed with the FDA that Kirkman-Campbell was not on the list and prevented from doing clinical research even though she was convicted of fraud. Eshelmann said the company does check the FDA list.

“If the debarment process is flawed, it could present serious issues,” Eshelman told members. The committee released a report critical of the debarment process Feb. 12. Read it here.

While CROs can be buoyed a bit from the hearing, they and their lobbying group, ACRO, still have a big job ahead of them keeping Congress informed about how research actually works. We are sure they will be asked more questions about the debarment list and investigator selection. Keeping Congress informed on these issues is a very big job.

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