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Congressmen On War Path Over FDA Approval Of Ketek

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French drug giant Sanofi-Aventis has stopped enrolling pediatric patients in clinical trials for Ketek. On June 9, 2006, the drug maker said it halted tests on its own to ensure that trials of the drug complied with FDA requirements.

The company denied that the studies were suspended because of safety concerns. However, the move jives with the recently initiated investigations into the FDA's collusion with Aventis in the approval of Ketek by two powerful Congressional Committees.

The FDA's conduct regarding Ketek is under investigation by House Representatives Edward Markey (D-MA), and Henry Waxman (D-CA), senior Democrats on the House Energy and Commerce Committee. On May 1, 2006 the lawmakers sent a letter to the FDA questioning its actions surrounding the approval of Ketek.

In a press release announcing the investigation, the lawmakers said, "though the FDA has consistently assured the public of Ketek 's safety and efficacy, public documents obtained and examined by Reps. Markey and Waxman 's staff indicate that the approval process for this drug was seriously flawed."

Most recently, on June 8, 2006, the Senate Finance Committee sent a letter to the FDA asking: "Is the FDA considering temporary suspension of these trials until the serious concerns and issues related to Ketek are resolved?"

The company had been testing Ketek for treatment of ear infections and tonsillitis in nearly 4,000 children in the US and a dozen or so other countries. A search of the Clinical Trials.gov web site shows three ongoing trials in the US of children ages 6 months to 13 years, including:

(1) TELI COM - Telithromycin in Children With Otitis Media,

(2) TELI TON - Telithromycin in Tonsillitis, and
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(3) Comparative Study to Evaluate the Efficacy and Safety of Telithromycin Given Once Daily Versus Cefuroxime Axetil Given Twice Daily in Children With Middle Ear Infections.

A fourth trial, "TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults," involves children 13 and older.

The FDA approved Ketek on April 1, 2004, for the treatment of adults with community-acquired pneumonia, sinusitis, and acute exacerbation of chronic bronchitis.

Over the past several months, several allegations related to the FDA's approval of Ketek have caught the attention of the Senate Finance Committee Chairman Senator Charles Grassley (R-Iowa).

The Senate Committee has jurisdiction over the Medicare and Medicaid programs and, accordingly, a responsibility to the more than 80 million Americans who receive health care coverage, including prescription drugs, under those programs.
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Senator Grassley 's intense oversight of the FDA began in 2004 over the agency 's reluctance to allow information to become public about the risks of pediatric use of SSRI anti-depressants. He has since put pressure on the FDA to make administrative changes to improve its transparency and post-market surveillance of drugs, in addition to introducing legislation to implement these kinds of reforms.

Among the most serious allegations about Ketek is that the FDA approved the drug despite unresolved questions about the drug 's safety and efficacy, with full knowledge that some of the clinical data submitted to support the drug's approval was tainted by integrity problems. Documents provided to the Senate Committee show that at least one of the clinical trials, Study 3014, was fraudulent.

In April 2001, Ketek's initial approval came before the Anti-Effective Drugs Advisory Committee to consider whether its efficacy in treating respiratory infections supported its use given the risks of cardiac and hepatic toxicity and vision problems associated with Ketek.

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Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.

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