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