Ketek whistleblower knew years before about liver injury danger

On Feb. 12, 2007, Dr. David Ross was vindicated in his Ketek findings. That was the day that the former Food and Drug Administration (FDA) finally removed bronchitis and sinusitis from the list of appropriate Ketek uses, and added stronger warnings about the possibility of serious liver failure and even death – all of which Dr. Ross noted years before.

So why if FDA scientists knew about the dangers did the agency approve Ketek? That question strikes straight at the heart of an investigation into FDA practices, and specifically how it allegedly “shuts up” scientists who want to tell the truth.

Despite knowing the risks of harassment and loss of his job, Dr. Ross told the Bloomberg News that he had to come forward with his findings and testify before a congressional committee in February 2007. "I felt like if I didn't do something and people got hurt, I wouldn't be able to stand it," he said. "I'm getting a chance to say what the problems are, and I'm getting a chance to fix them." Dr. Ross left the FDA in November 2006.

A similar incident occurred during the congressional Vioxx hearing. Dr. David Graham was that drug’s whistleblower despite attempts by the FDA to keep him from testifying. He also had comments on Ketek that were published in a letter in the November 23, 2006 issue of the New England Journal of Medicine. There are many other examples of FDA scientists being coerced into silence, which perhaps made Dr. Ross’s job this time around a little bit easier.

Dr. Ross described an environment where scientists were routinely asked to follow the party line. His initial safety review of Ketek noted that its side effects and possible liver injury meant that the antibiotic was too dangerous for common infections like sinusitis and bronchitis. However one of his superiors asked him to “soften up” his position, despite his scientific arguments.

The main problem is that many scientists use their time at the FDA as a sort of proving ground before accepting higher-paying jobs at the pharmaceutical companies. With this lack of “arm’s length” regulation, it is not surprising that many drugs reach market that should not. Ketek was approved in 2004 after being rejected in 2001 and 2003 – despite objections like those from Dr. Ross.

Ultimately it is the drug manufacturers like Ketek’s Sanofi-Aventis that are responsible for the safety of their products. If you have been injured by Ketek or any other type of medication, contact a Jim S. Adler & Associates personal injury attorney for a free case review. We can help you understand why the drug is harmful for you, and what you can do legally to get compensation for your injuries. Call us directly or fill in the form on this page with the details of your Ketek experience, and we will contact you.

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