As a follow up to my original post about the FDA approval of Ketek, I did myself a favor and listened to the 16 minute interview Dr. David Ross gave to Rachel Gotbaum on the NEJM website. My goodness, this man deserves a medal of freedom way more than Wolfowitz and Tenet.
I plan to talk more about the FDA in future posts (its becoming my personal mission), but I just want to highlight some of the things Ross said in this interview.
Apparently, the fraud that occurred with Sanofi Aventis’ safety study (you know, the one where the top enroller is in a federal prison, and the second top enroller…is ALSO going to prison)… the company KNEW ABOUT IT and DIDN’T TELL ANYONE!!! What the f&%$!!! Is anyone going to jail for this? When confronted, they basically said “We’re sorry, and we promise we won’t do it anymore.” And the FDA claims in their letter to the Journal they only had “preliminary” evidence that fraud occurred at the approval committees. But, GUESS WHAT??? Dr. Ross says that that’s a bunch of BULLS%^&$!!! They knew the whole time!
In January of this year, the FDA wisely withdrew the indications of AECB and acute sinusitis from the Ketek label because “the risks outweigh the benefits”. Thank goodness they realized it after three long years. BUT WAIT…Dr. Ross told them exactly that…IN 2003!!!!! When he presented his opinion, he was told by his manager to “soften” up his report.
Why would his manager ask such a thing, the interviewer posits. And that’s when Dr. Ross issues my favorite phrase of the interview. He says that as of 10 years ago, the FDA’s mission has changed, and now there is… are you ready?... a “culture of approval”! Yes, that’s what we need at the nation’s safety-in-drugs watchdog.. a culture of approval.
The interview is a tour-de-force. I was speechless. He never mentions von Eschenbech, or any top person at the FDA by name because he is obviously too much of a gentleman or statesman. But one cannot deny that based on this report, the FDA are:
Why do I say “evil”? Well, I don’t know what else to call approving a shoddy drug that led to 4 people dying of liver failure and dozens of others getting liver toxicity NEEDLESSLY!! This wasn’t like they made a medical mistake. They KNOWINGLY approved a drug based on flawed safety data made by a company who covered up the fraud.
As Neil Rogers would say “UN-believable!”