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Context of 'January 8, 2003: FDA Panel Recommends Approval for Ketek Despite Problems with Clinical Study'

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The FDA informs Aventis that it will not approve the drug Ketek until the company has provided enough information to determine the drug’s safety profile. (Aventis 6/4/2001) In April, an FDA advisory board recommended additional clinical studies for the drug because of concerns about potential side effects on the heart and liver (see April 26, 2001).

Aventis contracts Pharmaceutical Product Development, Inc. to do a clinical trial for Ketek, an antibiotic designed to treat respiratory infections. The trial, named “Study 3014,” is being done because of FDA concerns (see Early June 2001) about possible links to heart and liver problems. The company pays doctors $400 for each patient they enroll in the study. Some of the doctors—a bit overzealous in recruiting patients—forge signatures, sign up family members, and invite patients into the study who do not have infections. There are also problems with the way some of the doctors collect and record their data. One doctor, who enrolls 251 patients, does not follow the study’s instructions and fails to report adverse drug reactions. Another physician, Dr. Maria Anne Kirkman-Campbell, who runs a weight-loss clinic, signs up 407 patients—but only 10 percent of them actually take the drug. These problems are discovered by FDA inspectors in fall 2002. (ABC 1/14/2006; Mathews 5/1/2006 pdf file)

After reviewing results of clinical study 3014 for the antibiotic Ketek, an FDA advisory panel recommends that the drug be approved. (Aventis 1/9/2003) The panel makes the decision completely unaware that the FDA had discovered problems with the study only a few months before. (ABC 1/14/2006; Mathews 5/1/2006 pdf file) In October, an FDA examiner found that some doctors were reporting fraudulent results. For example, some doctors had failed to record the data properly while others had invited patients into the study who did not meet the necessary qualifications. In one case, several patients who were enrolled in the study were not actually taking the drug (see October 2001-Fall 2002).

Aventis announces that the FDA has again declined to approve the company’s antibiotic drug Ketek, citing the need for additional analyses and information pertaining to Study 3014 (see October 2001-Fall 2002). (Aventis 1/27/2003)

The FDA’s Division of Scientific Investigations says in a memo that Aventis’s clinical study for the drug Ketek, study 3014 (see October 2001-Fall 2002), “uniformly failed to detect data integrity problems when they clearly existed.” The report notes that doctors participating in the study failed to comply with FDA regulations and were found to have engaged in “multiple instances of fraud.” (Mathews 5/1/2006 pdf file)

The FDA approves the drug Ketek for treatment of chronic bronchitis, acute bacterial sinusitis, and community-acquired pneumonia in patients age 18 and older. (Aventis 4/1/2004) The approval decision is made despite evidence that a 2001-2002 clinical trial for the drug, study 3014, was replete with fraudulent data (see October 2001-Fall 2002). The FDA says the approval is based on data submitted in 2000, other studies, and the drug’s safety record overseas where the drug has been in use for several years. (Mathews 5/1/2006 pdf file)

The Annals of Internal Medicine posts an “early release” version of an article reporting three cases of acute liver failure in previously healthy patients who had taken Ketek. (Alonso-Zaldivar 6/17/2006) The final version of the article will be published in late March. (Clay et al. 3/21/2006) The FDA, responding to the new data, insists the drug presents no more danger to the liver than other antibiotics. The agency even cites the results of Study 3013, which FDA investigators previously determined relied upon fraudulent data (see October 2001-Fall 2002 and March 25, 2004). (Mathews 5/1/2006 pdf file)


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