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Controversial antibiotic Ketek will face more FDA scrutiny

Dec 10, 2006 | USA Today

As antibiotics go, Ketek has had a pretty high profile.

Sen. Chuck Grassley, R-Iowa, tried in vain last week to block Andrew von Eschenbach's confirmation as Food and Drug Administration commissioner, partly because of what the senator views as FDA efforts to hinder his investigation of clinical trials of the drug, which has been linked to fatal liver problems.

"The way the FDA under this nominee has handled the investigation of Ketek shows the agency would like to keep its business secret," Grassley said on the Senate floor Thursday prior to von Eschenbach's confirmation. "It doesn't want these issues made public or subjected to the scrutiny."

In addition, just two months after the FDA approved Ketek in April 2004 for the treatment of pneumonia, sinusitis and bronchitis, the Public Citizen Health Research Group, a patient advocacy organization based in Washington, D.C., added the antibiotic to its list of "do not use" drugs.

Public Citizen cited reports of liver toxicity, serious vision problems and the possibility of heart rhythm disturbances.

Some of these issues will be discussed Thursday and Friday when the FDA convenes a joint meeting of its Anti-Infective Drugs and its Drug Safety and Risk Management advisory committees to discuss what it calls Ketek's "overall benefit-to-risk considerations."

Doug Greene, chief U.S medical officer for Paris-based Sanofi-Aventis, which markets Ketek, says his company is looking forward to presenting "lots of scientific information that we feel strongly reinforces the positive benefit/risk equation for Ketek for serious infections."

Worldwide, Greene says, 28 million people have taken Ketek. In the USA, Ketek sales totaled nearly $200 million in 2005, according to IMS Health, a pharmaceutical information and consulting company.

"With any new drug, there's always an ongoing process to continue to gather new information," Greene says. "We're following that process, the FDA is following that process. It's working. That's why we are here to have this discussion" at the advisory panel meeting.

But John Powers, former lead medical officer for the FDA's anti-microbial drug development and resistance initiative, calls the meeting "a kangaroo court."

Powers says he spent eight years at the FDA before leaving two months ago because of the lack of a "scientific approach, especially in the area of antibiotics."

Sanofi executives "are going to get up there and yammer on and on: 'In a test tube our drug is more potent than these older drugs,' " says Powers, who is to testify at the hearing Friday as a public citizen. "What we want to know are what are the effects in human beings?"

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