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FDA Weighs Fate of Antibiotic Ketek

Expert Panel Hears Testimony on Safety of Controversial Drug

More Serious Cases

But an analysis commissioned by the agency found 35 cases of severe injuries -- including seven resulting in a liver transplant or death -- that analysts say were very likely attributable directly to Ketek.

"What we have is a higher number of these hospitalized patients" than are seen with other drugs, said William Lee, MD, director of the Clinical Center for Liver Diseases at the University of Texas Southwestern Medical Center and one of the analysts commissioned by the FDA.

The advisory committee is scheduled Friday to consider other data linking Ketek to other side effects, including temporary blindness and abnormal heart rhythms.

Senate Criticism

The meeting is taking place against a backdrop of stark criticism from the Republican chairman of the Senate Finance Committee, which has spent the last year investigating the FDA's handing of Ketek's approval.

A committee report released Wednesday concluded that FDA officials did not tell the advisory panel in 2003 that a Sanofi Aventis safety study, called 3014, was flawed.

"In sum, the FDA did not ensure that the public received accurate, science-based information regarding the Ketek (application)," Sen. Charles E. Grassley, R-Iowa, wrote in the report.

"If the FDA could not find a way to present only accurate, science-based information, the FDA should not have presented study 3014 publicly, or alternatively, should have postponed or canceled the [Senate committee] meeting," the report said.

FDA officials have said they did not take that study into account when they approved Ketek. They instead relied on European safety studies attempting to measure Ketek's safety on the market in France, Germany, and other countries.

Jenkins, who leads the FDA division in charge of approving new drugs, said he had not yet digested the 53-page report from Grassley's committee.

"I don't want to get into the details of that today," he told reporters.

Controversy surrounding Ketek's approval is also bringing harsh criticism from inside the agency.

David Graham, MD, a scientist in the FDA's Office of Drug Safety, wrote a brief article in the New England Journal of Medicine in November condemning agency officials for resorting to overseas postmarket safety studies to approve Ketek in 2004. Such data are generally considered far less reliable than controlled studies like the 3014 trial.

In an interview, Graham called the hearings an example of "damage control" over Ketek safety issues that have come back to haunt the FDA.

"This is medicine gone bad, basically," he tells WebMD. "This is FDA lying to the American people. If we can't trust them to be honest in this setting, why can we trust them to be honest with anything?"

Jenkins did not comment on the decision to present the data to the panel in 2004.

He said that no evidence of additional safety issues in 4 million European patients made the officials "comfortable making the decision for approval."


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