Questionable,FDA,Practices,Reg health Questionable FDA Practices Regarding Ketek
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There are two allegations regarding the circumstances about howthe FDA approved Ketek for the marketplace: Questions arose about how the FDAsmanagement instructed FDA officials to present fraudulent data to the AdvisoryCommittee because discussing issues regarding data integrity and the conduct ofa safety study would not be productive; and, did the FDA actually presentingfraudulent study data to the Advisory Committee?About two months prior to the 2003 Advisory Committee meeting, the study sitewith the largest number of enrolled subjects (407) was under investigation byFDAs Office of Criminal Investigations. The FDA also inspected the second andthird highest enrolling sites and found them to have similarly violated theprotocol. In addition, 72 other sites raised red flags for FDA officials andinvestigators, including non adherence to the study protocol, which recommendedbetween 4 and 50 study subjects per site. FDA officials also questioned howquickly more than 24,000 patients were enrolled in the study. The FDA official charged with presenting at the Advisory Committee stated thathe was not satisfied with what he knew about the integrity of a study and wasagainst presenting it. When asked why he did indeed present a study he knew tohave data integrity problems, the official replied that he was asked directlyby the FDA Division Director. The Advisory Committee members said they were not aware of the data integrityproblems until July 7, 2006. Several Advisory Committee members also responded thatknowledge of the data integrity problems might have affected their vote. Ketek received a seal of approval amidst and botched and questionable study ofparticipants who never existed.
Questionable,FDA,Practices,Reg