Panel Features Drug Maker Sanofi-Aventis Official, GAP Client who Discovered Company Knew of Fraudulent Trails

(Washington, D.C.) – Tomorrow, February 12, Government Accountability Project (GAP) client Ann Marie Cisneros will testify at a House Subcommittee on Oversight and Investigations hearing titled “Ketek Clinical Study Fraud: What Did Aventis Know?” The hearing is set for 11:00 a.m. at 2123 Rayburn House Office Building.

Ketek is an antibiotic manufactured by Aventis (now Sanofi-Aventis) that was originally approved to treat a host of respiratory ailments in August 2004. Last February, the FDA withdrew approval for two of three uses for the drug, and issued a “black box warning” for its use in treating community-acquired pneumonia. This warning was issued in the wake of numerous Ketek patients suffering adverse events. As of September 2007, the FDA had received an estimated 93 severe adverse reaction reports for Ketek, including 27 cases of severe liver failure and 12 fatalities.

Cisneros served as a clinical research associate for PPDI, a contract research organization that conducts clinical trials on behalf of drug sponsors. Last February, Cisneros appeared at a hearing held by the same committee focusing on the FDA’s failure to ensure safe prescription drugs. Cisneros testified that Aventis knew of fraudulent clinical trial data involving Ketek, but that the company chose to ignore it. Cisneros also testified that Aventis officials coached a doctor on “how to explain away improper conduct” in the trials. Her revelations only emerged after that doctor was sentenced to 57 months in prison for her role in the fraudulent clinical trial. The court had treated Aventis as an unwitting victim of, rather than an accomplice in, the fraud and actually ordered the doctor to pay restitution to the drug-maker.

Cisneros will appear in the second panel of tomorrow’s hearing, along with several FDA and government investigators who will report their findings into the matter. The first panel will consist solely of Sen. Charles Grassley (R-Ia), a whistleblower champion who has investigated Cisneros’ and FDA officers’ charges of wrongdoing against Sanofi-Aventis and the FDA regarding the drug’s approval.

The third panel includes several corporate representatives. Paul Herbert Chew is the President of the U.S. Research and Development Division of Sanofi-Aventis. This marks the first time a Sanofi-Aventis official will testify regarding Ketek. Also testifying in the third panel will be Fred Eshelman, CEO of PPDI, and Sharon Price, CEO of the Copernicus Group. The Copernicus Group is an “Independent Review Board” that is supposed to report possible risks to patient safety to the FDA. Cisneros contacted the Copernicus Group when she discovered the massive fraud, but Cisneros testified that the Group took no action.

Mark Cohen, GAP Executive Director, represents Cisneros. “The scary news is that the FDA management shepherded this dangerous and unproven drug onto the market, despite flashing red lights from the drug’s clinical trials and dire warnings from FDA’s own medical reviewers,” said Cohen. “The good news for the public health is that people of conscience like Ms. Cisneros were willing to risk their careers to tell the truth about Ketek.”