Kristen Sparrow • March 29, 2009
In yet another depressing instance of profit motive undermining patient well-being we are presented with the story of a private company, “Coast Independent Review Board”, charged with overseeing the safety of new drugs and medical devices (An Overseer of Trials in Medicine Draws Fire Published: March 26, 2009 NYtimes.) “Coast,”located firmly inland in Colorado Springs, was snared by undercover federal agents when it approved a make-believe surgical device rejected by two of Coast’s competitors.
“Where was the due diligence of your company?” demanded Congressman Stupak at a Congressional hearing on Thursday March 26th. In retort, remaining as combative and self-righteous as any thug worth his salt, the CEO Drueber griped that he could not imagine why anyone would design a fake trial. (You mean besides catching frauds?) “I cannot believe that my government did this to me and my company. It is unconscionable.”
What is “unconscionable” is a company that is willing to sign off on potentially dangerous drugs or devices for a fee. There have been recent hearings on patient deaths from unsafe devices which were allowed because of fraudulent data submitted to the FDA. The charges against Coast are not trivial. In recent years, review of new medical devices and drugs has shifted from academic medical institutions to private review companies that are paid by the company that develops the new device. This setup can lead to corruption of the process as seems to have happened at Coast.
Following the money we find out from the article that “over a five-year period, Coast reviewed 356 study proposals and rejected only one, according to data presented at the hearing. Meanwhile, since 2004 the company’s revenue has more than doubled, to $9.3 million in 2008.”
It cuts down on outlays if you don’t actually do the work of reviewing and increases profits if drug companies seek you out because you’re known to overlook rather than oversee.
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