"When they allow a talk show host to play them like a two-dollar banjo, they demonstrate what kind of backbone they'll bring to the job later on, if we elect them. After they get elected will they continue to allow Jeff Crank to put a nickel in them and wind them up every Saturday morning?"

Barry Noreen, former columnist, Colorado Springs Gazette

Friday, June 19, 2009

The Curious Case of Coast IRB

On the morning of May 14th, 2009 a dark comedy of sorts played out in Colorado Springs.

The dark comedy was played out by two casts of characters: the men with jobs on one side, the men and women without jobs on the other. Their actions couldn’t have been more perfectly choreographed. The men with jobs arrived at a lifeless office on the morning of May 14th, 2009 and began dismantling desks, cubical walls, and offices. The men and women without jobs arrived at unemployment offices and filed for their benefits. And as each cast played out their parts separate from one another, they were indeed linked by the dark and cynical clutches of fate-and Coast Independent Review Board (IRB). Had Coast IRB not gone out of business and thus laid off their 137 employees, neither cast would have intersected at the crossroads of fate. Maybe the roles would have been reversed and the movers, without work, could have headed towards the unemployment offices.

Ah, life’s little ironies.

But who cares, right? We’re somewhere near the middle of the Great Recession, and so stories of lay-offs, unemployment, and offices being emptied by movers have become rather routine, haven’t they?

Coast IRB is different. The chain of events that culminated in the little dark comedy of May 19th is unlike anything I have ever seen before. Is this a story about a sloppy company who violated the law or an over-reaching government witch hunt? Take a look at what happened and decide for yourself.

For those of you who are not familiar, IRB’s are review boards that are paid by “drug and device makers to oversee clinical trials and independently ensure that patient safety is protected.” In other words, they work with medical companies, pharmaceuticals, etc. which as even the most irregular political observer knows is a favorite whipping boy for a political party which shall remain nameless…

In any case, a few months ago the U.S. Government Accountability Office (GAO) working off of the instructions of the U.S. House Subcommittee on Oversight and Investigations for the House Committee on Energy and Commerce decided to “test” IRBs. They created a false medical device, a company, and other reports to submit to IRBs in an attempt to see if the IRB would discover the fake out and thus deny the company their application to proceed with trials.

Apparently Coast IRB didn’t pass the test. According to the GAO report and congressional testimony, Coast IRB “approved our bogus research protocol for human subjects testing after only minor edits to our submission materials, even though we were a bogus company with falsified credentials and an unproven medical device.”

After Coast IRB approved the factious company’s request to begin human trials, the CEO received a letter from the FDA informing him of the sting and the subsequent results. Soon thereafter warning letters were issued, congressional testimony was given and clients lost confidence. An agreement was reached between Coast IRB and the FDA, and the reviews ceased. Inevitably, Coast IRB closed and 137 people lost their jobs.

Who’s to blame for the downfall of Coast IRB and the sad intersection of fate that resulted? Do we blame Coast IRB and their business practices that could have endangered lives? Or do we blame an over zealous congress engaged in witch hunts against “big pharmaceutical” or “big drug companies”? Did Coast IRB fall asleep at the wheel, or did the GAO set them up for failure.

Here are the articles regarding what happened. I invite you to look at them and decide for yourself.

http://blogs.wsj.com/health/2009/04/14/after-falling-for-fake-study-review-board-steps-aside/

http://online.wsj.com/article/SB124042341694744375.html

http://www.coastirb.com/coastirb_fda

http://www.fda.gov/bbs/topics/news/2009/new01996.html

http://www.reuters.com/article/pressRelease/idUS233806+11-Mar-2009+BW20090311

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