Coast Independent Review Board, a Colorado company that drug and medical device manufacturers pay to oversee patient safety during clinical trials, has come under criticism at a Congressional hearing regarding whether the company performed its duties adequately. Undercover federal investigators created a fake medical trial of a bogus surgical product called Adhesiabloc in order to see how closely companies like Coast monitored the studies they were paid to review. Two of Coast’s competitors refused to approve the study’s design, while Coast approved the trial.
Coast’s chief executive officer, Daniel Dueber, accused the government of "extensive fraud" against his company and remained combative throughout the hearing. He said he cannot imagine why the government would create a fake trial and also cannot believe the American government would do something like this to his company.
The hearing was initiated after incidents in recent years involving patients dying during clinical trials or companies submitting fraudulent information to the Food and Drug Administration (FDA) in order to get new medical products approved. During this period of time, the oversight of clinical trials has shifted from academic medical institutions to companies like Coast. There is a growing concern that these commercial review boards may be too heavily influenced by the drug and device companies that pay for their services. Critics also say that manufacturers will shop around for a board that will accommodate them after other reviewers reject their research plans. Over a period of five years, Coast reviewed 356 studies and only rejected one. Meanwhile, the company has more than doubled its revenue since 2004. A separate FDA inspection last year led to Coast receiving a warning letter after officials discovered an unqualified person was used to approve an advertisement to recruit trial subjects.
In a recent report, officials at the Government Accountability Office (GAO), a research arm of Congress, said they found the commercial review system to be extremely susceptible to manipulation. It was the GAO who set up the sting mission at Coast. According to the FDA, Coast has since submitted a plan to improve its procedures following GAO’s investigation. The hearing also focused on whether the FDA and Department of Health did their job in overseeing clinical trials to protect the patients.
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