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KETEK CLINICAL TRIALS
by Jane Mundy
Clinical trials for the antibiotic Ketek (Telithromycin) have proven to be fraudulent and investigations into Sanofi-Aventis, the manufacturer, are ongoing.
In February 2008, a clinical investigator in a Ketek trial pleaded guilty to fraud and went to prison. Dr. Kirkman Campbell falsified data in her portion of the clinical trials because Ketek seemed to cause liver problems, including liver failure, to a greater extent than would be expected of a common-use antibiotic. Sanofi-Aventis, the manufacturer of Ketek, had concerns about Dr. Campbell early in the trial but chose not to notify the FDA.
On March 19th, the FDA sent a warning letter to Dr. Shah, a second Ketek clinical investigator involved in two studies of the drug, stating that he enrolled ineligible subjects, allowed subjects to take prohibited medications in conjunction with Ketek, improperly kept the study drug in an unlocked cabinet, retroactively modified study records with undated handwritten notes, did not report adverse events and failed to get proper informed consent. On its website, the FDA concluded that Dr. Shah "did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects."
Due to the shoddy manner in which the phase III clinical trials were held, questions have been raised about the validity of data and subjects involved in the trials may have been exposed to unnecessary risks. And the question arises: should Ketek have been approved by the FDA and allowed on the market?
The FDA is also in trouble. Congress asked the Government Accountability Office to examine the agency's reasons for delaying disciplinary proceedings against clinical investigators who have engaged in misconduct, particularly the FDA's handling of handling of fraud committed during a Phase III clinical trial of Ketek.
Back in July 2006, The New York Times reported that an FDA safety official argued that Ketek had not been proven safe, that there were safer alternatives, and the drug should be withdrawn immediately. Three other FDA officials also condemned the approval. At that time, 14 cases of liver failure had been reported, at least four deaths and many adverse side effects, from vision problems to Myasthenia gravis--a chronic autoimmune neuromuscular disease characterized by varying degrees of weakness of the skeletal (voluntary) muscles of the body. The FDA officials asked: "How does one justify balancing the risk of fatal liver failure against one day less of ear pain?"
By April of 2008, at least 18 deaths and 134 cases of liver damage had been reported to the FDA. Some experts believe the death count is much higher.
If you develop symptoms, or you have lost a loved one who was taking this drug, you may want to contact a Ketek attorney who will review your case at no charge.
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