There are two
allegations regarding the circumstances about how the FDA approved Ketek for
the marketplace: Questions arose about how
There are two allegations regarding the circumstances about how
the FDA approved Ketek for the marketplace: Questions arose about how the FDA’s
management instructed FDA officials to present fraudulent data to the Advisory
Committee because discussing issues regarding data integrity and the conduct of
a safety study would not be productive; and, did the FDA actually presenting
fraudulent study data to the Advisory Committee?
About two months prior to the 2003 Advisory Committee meeting, the study site
with the largest number of enrolled subjects (407) was under investigation by
FDA’s Office of Criminal Investigations. The FDA also inspected the second and
third highest enrolling sites and found them to have similarly violated the
protocol. In addition, 72 other sites raised red flags for FDA officials and
investigators, including non adherence to the study protocol, which recommended
between 4 and 50 study subjects per site. FDA officials also questioned how
quickly more than 24,000 patients were enrolled in the study.
The FDA official charged with presenting at the Advisory Committee stated that
he was not satisfied with what he knew about the integrity of a study and was
against presenting it. When asked why he did indeed present a study he knew to
have data integrity problems, the official replied that he was asked directly
by the FDA Division Director.
The Advisory Committee members said they were not aware of the data integrity
problems until July 7, 2006. Several Advisory Committee members also responded that
knowledge of the data integrity problems might have affected their vote.
Ketek received a seal of approval amidst and botched and questionable study of
participants who never existed.
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or died after taking ketek antibiotic, you may have grounds for a ketek lawsuit. Find out what your options are by
contacting the personal injury/product liability lawyer, Michael Monheit : ketek lawyer
