A third-party, one that was contracted to oversee Ketek's safety trials, noted irregularities in the doctor's data and had a teleconference with Sanofi-Aventis to inform company officials of the irregularities. However, the drug-maker took no immediate action in the incident.
Meanwhile the FDA sent its own officials to top-enrolling doctor's offices. In all, the FDA investigators visited ten high-enrolling offices and found serious problems at each office. Despite this, FDA officials told scientists not to inform an advisory panel, one that would recommend whether or not the FDA should approve Ketek, about their concern regarding the validity of Ketek's safety information.
All of this occurred after Ketek was rejected by the FDA. In 2001, Sanofi-Aventis filed for approval but the FDA turned the company down saying that it required additional safety information before it could approve the drug. And yet, despite requesting further safety information and receiving data from a study filled with misinformation, the FDA ultimately approved Ketek for patient use.
Dr. Ross, as quoted in the St. Petersburg Times, noted that Ketek was used for illnesses that often clear up on their own over time. "This was not a drug that anybody thought was necessary in terms of public health," he said. "But it was important for the company financially."
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Ketek is known generically as telithromycin and was approved by the FDA in 2004. It was initially approved to treat acute bacterial exacerbation of bronchitis and acute bacterial sinusitis. However, it is no longer approved for those conditions and is now only approved to treat community-acquired pneumonia (that is, pneumonia acquired outside of a hospital) of mild to moderate severity. Ketek also now carries a black box warning about potentially deadly side effects including liver failure and aggravation of myasthenia gravis.