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Fake company gets approval for risky trial

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posted on Apr, 2 2009 @ 03:16 PM
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YOU would hope that a fake company, proposing to test a risky medical procedure, would be turned down flat. But that's not what happened in an elaborate "sting" operation set up to probe the US system for protecting volunteers in clinical research.


Fake company gets approval for risky trial

Amazing that most physicians, and physician students, with whom I speak would contend (wrongly) that the process for getting medicines, procedures, and medical devices to market is so costly, that this factor alone is why health care is so expensive in the US.

But here's a wrinkle....


The GAO submitted the fake proposal to three commercial IRBs, two of which rejected it. But Coast IRB of Colorado Springs approved the proposed trial by a unanimous vote, describing it as "probably very safe". The Committee on Energy and Commerce also found that Coast approved all 356 proposals it received in the past five years, and earned $9.3 million for its services in 2008 alone.


Anyone think we're any safer than before the IRB process was implemented?




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