Ketek and the FDA coverup

Dr. David Ross, former Food and Drug Administration (FDA) physician who helped review Ketek, said that there were "lessons to be learned" from the events leading to Ketek's eventual FDA approval. Just seven months after it was approved, according to Dr. Ross, the first death from Ketek-associated liver failure occurred. Since then there have been at least 53 other cases of severe liver injury or failure, and a total of at least four deaths.

Although Dr. Ross himself does not come out and say that the FDA tried to cover up its role in this tragedy, his descriptions of the events and the FDA's own rebuttal in the New England Journal of Medicine (NEJM) seems to support that viewpoint. In his NEJM editorial “The FDA and the Case of Ketek” published April 19, 2007, Dr. Ross gave a timeline of the Ketek approval process. Sanofi-Aventis, the drug’s manufacturer, submitted and re-submitted its application three times before it was finally approved in April 2004.

However the interesting part is that during the Ketek approval process, the FDA raised its standards in terms of the types of clinical trials a drug must pass before it can be approved. Specifically, the FDA decided that new drugs should be tested against current treatment methods to compare effectiveness. Conducting clinical trials that simply measure itself against a placebo, called a “noninferiority” test, was not considered to be good enough anymore.

But this was exactly the kind of test the FDA allowed Sanofi-Aventis to conduct when it first asked for more safety data back in 2001. So, in a sort of “grandfather clause,” the FDA let it slide, and approved Ketek based on this trial.

To make matters worse the clinical trial, called Study 3014, was riddled with problems from its basic approach to the fact that there was rampant fraud – one doctor is serving 57 months for fabricating patient lists to collect the $400 per Ketek sign-up from the company.

Yet despite this, the FDA approved Ketek mostly on the weight of this clinical trial. Dr. Ross said that it was “marked by pronounced departures from accepted review practices” and also said that there were internal pressures by senior FDA management to get Ketek approved. In its rebuttal letter, the FDA stated that there was “no intention to deceive” members of the review committee about the fraudulent claims in the clinical trial, and that although the noninferiority tests are “no longer considered acceptable,” that they were at the time Ketek was approved.

Perhaps most telling was the fact that former FDA acting commissioner Andrew von Eschenbach explicitly told reviewers not to discuss Ketek outside of the agency. This directive, given at a June 2006 meeting, was “in the face of Congressional subpoenas and unfavorable publicity” according to Dr. Ross. In other words, the FDA was in full damage control, covering up its own role in the approval of the deadly drug as much as possible.

Regardless of the FDA’s role in the Ketek tragedy, it is ultimately the drug’s manufacturer, Sanofi-Aventis, that is responsible for the safety of its medications. If you or a loved one has suffered severe liver damage while taking Ketek, even if it was for a very short time, contact  a Jim S. Adler & Associates personal injury lawyer. The firm can give you a full review of your case, and give you free advice about your compensation claim. Call directly right now, or fill out the form on this page with the details of your Ketek injuries, and someone from Jim S. Adler & Associates will get back to you with your free case review.

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