The Confessions of a Former FDA Reviewer – an Interview by Martha Rosenberg

Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety

Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety
Martha Rosenberg is an investigative health reporter. Her first book, “Born With a Junk Food Deficiency” has just been released

The Food and Drug Administration (FDA) is often accused of serving industry at the expense of consumers. But even FDA defenders are shocked by reports of an institutionalized FDA spying program on its own scientists, lawmakers, reporters and academics that included an enemies list of “actors” and collaborators. ”

Martha Rosenberg to Ronald Kavanagh:

  • 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.
  • What are some of the ways in which safety risks were minimized in drug evaluation and review? Would you give an example?
  • Like they are trying to pull the wool over the FDA’s eyes?
  • That is shocking. Wouldn’t the FDA managers want safety risks investigated?
  • You have recounted that this is what happened to you with the nerve gas drug pyridostigmine.
  • Another FDA reviewer turned down pyridostigmine before you?
  • So, you were just stating what should have been obvious?
  • Why would the FDA and DoD allow troops to be put in this kind of harm’s way?
  • Your training as a pediatric clinical pharmacologist has made you especially sensitive to drug risks for children. What are some of the unique drug risks children face?
  • Are there other risks with one-size-fits-all doses? Are the risks just ignored?
  • You have also spoken about the dangers of certain ADHD drugs and presented some damning data about Cephalon’s stimulant Provigil.
  • One of the pharma doctors actually tried to downplay SJS with modafinil, saying a child was hospitalized, but was not in the “burn unit,” according to the transcript.
  • The recent revelations of reprisals against FDA device reviewers must not have surprised you at all.
  • That is similar to the FDA’s claim with the device reviewers. Why do efforts to silence free speech always seem to be couched as “trade secrets”?
  • Still, the FDA transparency meeting transcripts indicate you not only went to members of Congress, you appealed to the Health and Human Services inspector general.
  • And in addition to this alleged wrongdoing, the public is at risk from unsafe drugs that were approved?

Read Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety
by Martha Rosenberg, Truthout, Interview 29 July 2012

More about Prescriptions Drugs – the FDA – the Pharmaceutical Industry.

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