Fraud Questions Surround New Antibiotic Ketek

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May 18, 2006 9:58 AM

Senator Chuck Grassley said it's "mystifying" why the Food and Drug Administration continues to rely on a "fraudulent clinical trial" regarding the safety of the antibiotic drug Ketek. 

Grassley, who chairs the Senate Finance Committee, is investigating why the FDA approved the drug to treat respiratory infections despite the agency's own findings that the pivotal study on Ketek was riddled with fraudulent information. A doctor who participated in the clinical trials recently pleaded guilty in connection to falsifying information about the study. 

Senator Grassley fired off a letter to acting FDA commissioner Dr. Andrew von Eschenbach demanding to know why the disputed clinical trial is still referenced in safety information on the FDA's website.  Grassley is also asking the FDA for access to investigators, documents and internal e-mails regarding Ketek. 

"The FDA has an obligation to be forthcoming about its actions," Grassley said.  "Serious allegations have been made about misconduct with the drug Ketek, and the public should not be misled about the safety of Ketek that cites a fradulent study."

Sanofi-Aventis, the company that manufactures Ketek, has previously said it was unaware of any fradulent activity regarding the clinical trials.  The FDA has defended Ketek's approval, saying the agency also relied on safety information from countries that had previously approved the drug.

Click here for the FDA's information on Ketek (Telithromycin).

Click here to read Senator Grassley's letter to the FDA Acting Commissioner.