Former FDA reviewer: intimidation, retaliation, safety marginalizing

Sunday, 29 July 2012 08:37
By Martha Rosenberg, Truthout | Interview

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 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-Iowa), ranking member on the Judiciary Committee, to FDA Commissioner Margaret A. Hamburg, the day after the breadth of the surveillance was reported in The New York Times…

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.”…

Ronald Kavanagh: 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…

Three examples from RK’s history with the FDA:

Pyridostigmine – both FDA and DoD public documents acknowledge increased lethality with other nerve agents such as Sarin, and DoD and other government documents that are public also document that Saddam Hussein was not using Soman and was instead using these other nerve agents exclusively. Yet because I raised this as an objection, I was immediately replaced as the primary reviewer so that I could not document my concerns and so that pyridostigmine could be approved..

Pediatric drug approvals – dosages used for studies in children are often based on approved adult dosages rather than a scientific determination of whether children achieve the same or higher exposures than adults… studies may also use overweight children as well as too few children. Since no allowance is made for race, age, puberty, or actual weight and since there are differences in children’s clearance of drugs, there are often higher exposures to active and toxic metabolites in children compared to adults. Thus there are often unnecessary risks with the doses that are approved.

Racial differences in drug metabolism – one anticancer drug breaks down faster in African Americans, so patients don’t get sufficient exposure to the drug to kill tumors. Yet African Americans were not included in the safety and efficacy studies. When drugs break down faster by one particular pathway, the patients will also sustain greater toxicity and even death from the toxic metabolite that is formed. This is especially true when the company subsequently recommends higher doses to overcome the lower exposure due to faster metabolism. In one case, this occurred with a drug used in pregnant women, where hormonal changes during pregnancy cause a greater breakdown to a metabolite that is suspected to cause mental retardation in children exposed during the pregnancy. Not only does the labeling suggest possible use during pregnancy, the labeling recommends a higher dose during pregnancy. All the while, it appears that the company was aware of the formation of a metabolite that likely affects brain development from well before the drug was ever submitted to the FDA.

You can read the full article with many more examples, including ADHD drugs and the FDA’s complicity with drug companies that know their drugs are toxic, here: http://truth-out.org/news/item/10524-former-fda-reviewer-speaks-out-about-intimidation-retaliation-and-marginalizing-of-safety

See also Jon Rappoport’s excellent article: New zombie medical drug to hit the streets – it’s called Zohydro – at www.nomorefakenews.com

Pharmaceutical drugs, street drugs – is there really a difference, other than corporate snakes wear well-tailored suits and their pushers wear white lab coats and stethoscopes around their necks? Threats of prison and death to reviewers if they don’t approve a drug?  Sounds like duh mob.

Lucky Luciano’s grandson on the Vatican, U.S. Govt, Hoffa, Hollywood… and much, much more!

Gambino said his prime motivation for telling the “inside details” of Mafia corruption is to prove to Americans how the Vatican and U.S. government work together in orchestrating the huge pedophile and drug rings that are destroying the fabric of American society. ~ Greg Szymanski

If you prefer reading to listening, here is a transcription of some of the most interesting points of the first interview, transcribed: http://www.arcticbeacon.com/articles/6-Oct-2007.html