Healthy Skepticism Library item: 15449

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Publication type: news

Meier B.
Overseer of Medical Trials, Under F.D.A. Pressure, Agrees to Suspension
The New York Times 2009 Apr 14
http://www.nytimes.com/2009/04/15/business/15device.html?_r=2&ref=business

Full text:

A Colorado company that approved a make-believe clinical trial run by doctors who did not exist got a dose of reality on Tuesday.

Under pressure from the Food and Drug Administration, the company agreed to temporarily suspend approving federally regulated medical studies or enrolling new patients in ones currently under way.

The agreement by the company, Coast Independent Review Board of Colorado Springs, could have an impact on its future operations. It may also affect some of 300 active studies involving human patients that Coast currently oversees on behalf of makers of drugs or medical devices.

Coast said last month that it planned to overhaul its procedures, a theme it emphasized in a statement released Tuesday. “Coast I.R.B. is changing everything, said the company’s chief executive Dan Dueber. “We are revamping every aspect of the company.”

Drug and device manufacturers pay companies like Coast to make sure that medical trials are performed ethically and that patient safety is protected. But last month, Coast first embarrassed itself, then became a Congressional whipping boy.

Coast’s troubles started when undercover federal investigators prepared plans for a sham medical study involving a make-believe surgical product to see how closely companies like Coast evaluate the studies they are paid to review. There is growing concern that commercial review boards may too easily accommodate companies that pay for their services.

Two of Coast’s competitors refused to approve the study plan. But Coast fell for the bait.

The company’s image was not helped by testimony last month by Mr. Dueber, at a Congressional hearing about his company’s actions. Mr. Dueber struck a combative attitude and claimed that the government had carried out an “extensive fraud” against Coast.

During that hearing, before the House Energy and Commerce Committee’s oversight and investigations subcommittee, several lawmakers questioned why the F.D.A., which oversees the conduct of clinical trials, had not taken action against Coast or even put it out of business.

On Tuesday, those lawmakers got something of an answer. The agency sent Coast a warning letter saying that it had found its actions and procedures in connection with the sham trial unacceptable.

For its part, Coast agreed to temporarily stop approving new clinical trials regulated by the F.D.A. until it had given the agency an acceptable plan of corrective actions. The F.D.A. is allowing trials now under way to continue, but Coast also agreed not to enroll any new patients in them until its corrective plan was approved.

At last month’s hearing, it was disclosed that Coast reviewed 356 study proposals over a five-year period and rejected only one of them. Since 2004, the company’s revenue has more than doubled, to $9.3 million in 2008.