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The FDA and The Socipathic Business Model™ Case Study

The FDA and The Socipathic Business Model™ Case Study

Congress Seal

The essence of good government is trust.

Kathleen Sebelius

From JAMA:

 The Food and Drug Administration (FDA) acted without regard for employees’ whistleblower rights, according to a joint staff report released February 26 by Rep Darrell Issa (R, Calif), chairman of the House Committee on Oversight and Government Reform, and Sen Chuck Grassley (R, Iowa), ranking member of the Senate Judiciary Committee.

Read the full report:


In 2009, several FDA scientists expressed concerns to Congress and the White House transition team that the agency was approving unsafe and risky medical devices. According to the report, when the FDA learned that scientists disclosed information about pending device applications, the agency began monitoring their computers at work. This allowed the agency to obtain sensitive information and protected communications between the scientists and their personal attorneys, Congress, and the Office of Special Counsel, which protects federal employees’ abilities to act as whistleblowers, stated the report.

Let’s run this activity through The Sociopathic Business Model ™, shall we?

The SBM with Logo final

-The FDA manipulated and did not recognize the rights of their employees.

– The FDA viewed their employees as accomplices who eventually became victims.

-The FDA showed lack of shame or guilt when intercepting protected communication of their employees.

-The FDA was shown to act irresponsibly towards their employees and perhaps even taxpayers.

Only the victim employees could answer this section:

Did the FDA motivate through fear?

Did the FDA create hopelessness?

Did the unethical actions of the FDA create an unhappy and unproductive work environment?

It’s implied that the FDA is rarely challenged by their employees since they resorted to illegal tactics.

Remember exposure to the truth which could damage the image of the abuser is the enemy to The Sociopathic Business Model ™.

Some other concerns I had:

This is one case we know about, so how many other times has this happened and the truth wasn’t exposed?  And were the employees concerns valid?  The report did not examine the merits of those underlying claims and takes no position on whether the devices in question posed a risk to public health.  So where does that leave all of us?  Are there unsafe devices out exposed by this case?  Are there unsafe medical devices out there that aren’t related to this case study? And has this ever happened with pharmaceuticals?  A lot of questions and not a lot of answers.

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