Former FDA Drug Reviewer Speaks Out About Pressures to Approve Drugs

Jul 29th, 2012 | By | Category: FDA

Martha Rosenberg for Truthout (here) interviewed Ronald Kavanagh B.S. Pharm., Pharm. D. Ph.D who reviewed drugs for the Center for Drug Evaluation and Research. There he says reviewers such as himself encountered suppression of safety research and intimidation.

Kavanagh tells Truthout:

     “In the Center for Drugs [Center for Drug Evaluation and Research or CDER], as in the Center for Devices, the honest employee fears the dishonest employee. There is also 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.”

Ronald Kavanagh says the recent reprisal against FDA medical device reviewers did not surprise him at all.  Earlier this year, a group of five current and former FDA medical device reviewers filed a whistleblower lawsuit claiming they were spied on by the agency when they spoke out and questioned the safety of certain medical devices. Background story here.

Kavanagh says when he too went to Congress to report problems within the FDA, “I saw a strange cursor movements on my computer when I was just sitting at my desk reading that I suspected was evidence of spying.”  He was threatened with prison if he released “trade secret information” to Congress.

Kavanagh says a manager threatened his young children at a large meeting and he, Kavanagh, was  referred to as a “saboteur.”

Why do efforts to silent speech always appear as “trade secrets? asks Rosenberg.

You can read the rest of the  Truthout article here.

In this blog which has partial transcripts from the FDA’s meeting on transparancy, Kavanagh says he was fired from the FDA for going to Congress, the Inspector General’s Office, and threatening to go to the FBI.

Rosenberg recently published “Born with a Junk Food Deficiency” (here) about the food and pharmaceutical industries and how consumers are kept in the dark.

 

 

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.