FDA approval really does (NOT) put my mind at rest

Congress appointed stinger

Even I, seasoned cynic that I am, found this hard to believe.   My eyes widened, my jaw dropped as I reached for pills to calm me down (no, not really).

A US congressional sting carried out several years ago exposed the FDA system for approving human trials in a way that is incredible, but true.   As Heidi Stevenson of Gaia Health wrote (see end for link to full article):

“The FDA farms out drug and medical device testing. It’s in the hands of the companies hoping to gain approval for their products. Overview, though, is required. Study plans must first be approved before testing can proceed on humans.

However, the FDA doesn’t review the testing plans. That’s done by for-profit companies called Institutional Review Boards (IRBs).”

Congress was not sure about this system, and got together with the General Accountability Office (GAO) to set up a sting.  A sting, for my non-native English readers, is a complicated game of deceit, used either to steal or, as in this case, to see whether people are doing what they are supposed to do…

First they set up a false company with a false, dangerous-sounding product – which was approved for testing.

Then they set up a proposal for a (fictitious) IRB.  The company name was Phake Medical Devices.  Company principals included Ms. April Phuls and Mr. Timothy Witless.  The application sailed through.

Well, really.  I leave you to draw your own conclusions…

Here’s the link for the full article.  Look at the links at the end of the article itself, as they give even more background to the story.