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Posts Tagged ‘drug approval’

Corrupt practi9ces at the FDA

Posted by Jonathan Chamberlain on August 13, 2012

Many people believe ‘science’ is the only true validator of any new drug. But what happens if that science is corrupt? Well, then – or so you would think – the watchdogs at the FDA would uncover the fraud and then punish the originator of that fraud. Or would they? Perhaps they would just wave the fraud through. That is the claim of a former FDA drugs analyst.

Ronald Kavanagh was a drug reviewer for the FDA in the Center for Drug Evaluation and Research from 1998 to 2008. In a recent interview he claims that the FDA bypassed or ignored safety issues on major drugs approved during his employment. In an interview  with Martha Rosenberg for the online news magazine Truth-Out he said:

There is … irrefutable evidence that managers at CDER have placed the nation at risk by corrupting the evaluation of drugs and by interfering with our ability to ensure the safety and efficacy of drugs. While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. We were prevented, except in rare instances, from presenting findings at advisory committees.

In 2007, formal policies were instituted so that speaking in any way that could reflect poorly on the agency could result in termination. If we asked questions that could delay or prevent a drug’s approval – which of course was our job as drug reviewers – management would reprimand us, reassign us, hold secret meetings about us, and worse. Obviously in such an environment, people will self-censor.”

For the full story read:


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