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Former FDA Reviewer Reveals Shocking Intimidation and Retaliation Within Agency



The FDA is often accused of serving industry at the expense of consumers. But even FDA defenders are shocked by reports this week of an institutionalized FDA spying program on its own scientists, lawmakers, reporters and academics that included an enemies list of "actors" and collaborators.


The paranoid and retaliatory email monitoring program, which sought to suppress the safety opinions of those hired to give their safety opinions, has provoked swift action from Capitol Hill. "I am writing to express my disappointment and disbelief with the way the Food and Drug Administration (FDA) has retaliated against whistleblowers who expressed concern to Members of Congress and the Office of Special Counsel (OSC) regarding safety concerns about medical products," wrote Sen. Charles E. Grassley, (R-IA), Ranking Member Committee on the Judiciary to FDA Commissioner Margaret A. Hamburg, the day after the breadth of the surveillance was reported in the New York Times. (Grassley)


Government agencies cannot discourage whistleblowing and reporting of wrongdoing by monitoring employees, echoed a White House memo sent to all government agencies about the FDA spy program.


"Devicegate" dates back at least to January 2009 when scientists in the FDA's Center for Devices and Radiological Health wrote President Obama that top FDA managers "committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along." Review procedures at the agency (which approves stents, breast implants, MRIs and other devices and machinery) were so faulty, that unsafe devices including those that emit excessive radiation were approved, charged the scientists, provoking an Office of Special Counsel investigation.


For reporting the safety risks, the scientists became targets of the now disclosed spy program and some lost their jobs. "It has been brought to our attention that FDA management may have just recently ordered the FDA Office of Criminal Investigations (OCI) to investigate us, rather than the managers who have engaged in wrongdoing!" wrote the FDA scientists in a follow-up letter a few weeks later to President Obama. "It is an outrage that our own Agency would step up the retaliation to such a level because we have reported their wrongdoing to the United States Congress."


During the same time period, Ronald Kavanagh, B.S.Pharm., Pharm.D, Ph.D., an FDA drug reviewer in the Center for Drug Evaluation and Research encountered similar intimidation and suppression of safety research. Truthout met with Dr. Kavanagh on several occasions to learn about his FDA whistleblowing experiences.


Rosenberg: You were an FDA drug reviewer from 1998 to 2008, working on well-known drugs like Cymbalta, Zyprexa, Concerta, Invega, Provigil and Saphris, and encountered the same kind of coercive working environment as the device reviewers.


Kavanagh: That's correct. 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.

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