Ketek approved despite not meeting FDA standards

In an editorial published in the New England Journal of Medicine (NEJM) on April 19, 2007, Dr. David Ross revealed that Ketek was approved for use despite the fact that its testing process did not meet current Food and Drug Administration (FDA) standards. The drug, approved three years ago, is an antibiotic that was initially marketed as the first in a “new generation” class of antibiotics that could destroy drug-resistant infections. However since that time Ketek has been linked to at least 53 cases of severe liver injury, including 12 cases of liver failure and four reported deaths.

Dr. Ross recounted the whole approval history of Ketek. Sanofi-Aventis, the drug’s manufacturer, first submitted it for approval in 2000. An FDA committee initially rejected the drug, asking that the company conduct a study to obtain safety data for its target patients.

Sanofi-Aventis did create a clinical trial for Ketek, the now infamous “Study 3014.” Right from the beginning, this trial was riddled with problems including poor research procedures, misleading findings, and many cases of outright fraud (one doctor is serving a 57-month sentence for her submission of fraudulent results). These instances of fraud are likely a result of the fact that doctors were paid as much as $400 to sign up patients.

Further, the study was considered to be a “noninferiority” trial. This means that the success of the drug is only measured against those patients who do not receive it. It is now generally accepted by scientists and by the FDA that new drugs must also be compared with available treatments to find how much better (or worse) the new treatment is. At no time was Ketek compared against other antibiotics.

Dr. Ross stated that once the FDA had already established that such a clinical trial could not prove Ketek’s effectiveness, “it might reasonably have been argued that the welfare of prospective patients ought to outweigh any promise to manufacturers. Yet the FDA accepted the trials without discussion of either the patients who might be exposed to a drug that had serious toxic effects — and for which there was no evidence of effectiveness — or the failure of the trials to meet the FDA's own standards at the time of approval.”

In a rebuttal letter printed in the same NEJM issue, a group of FDA officials admitted that the basis for Ketek’s approval would not be enough for the drug to be accepted today, but that “noninferiority studies were considered acceptable as the basis for approval for treatment of certain respiratory infections when the Ketek New Drug Application was submitted.” In other words, they had already made an agreement with the drug company and felt that it was more important to honor that agreement than to protect the safety of the American public.

If you or a loved one has been injured while taking Ketek or any other pharmaceutical drug, contact  Jim S. Adler & Associates personal injury attorney to get a fair and free case review of your rights. You may be entitled to a large settlement package to compensate you for your medical bills, lost work, and pain and suffering. But you should hurry – your statute of limitations could be running out. Contact Jim S. Adler & Associates directly by phone or fill in the facts of your Ketek case in the form on this page, and we will contact you. Make an informed choice!

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