Drug Trial Company Finds Itself Under Scrutiny

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http://www.nytimes.com/2009/03/13/business/13sting.html?_r=1&ref=todayspaper

Testing Firm Finds Itself Being Tested

By BARRY MEIER
Published: March 12, 2009


Like other federal undercover operations, this one had the usual trappings, like a company whose address turned out to be a P.O. box in a strip shopping mall and a businessman whose credentials proved fraudulent.

But the investigation had an unusual focus: determining whether companies that are paid to oversee the safety of patients in clinical studies of drugs and medical devices do their job. The inquiry came to light this week when one of its targets, a Colorado company, exposed it — via news release.

The company, Coast Independent Review Board, said it had been duped by federal officials last year when it agreed to oversee a study of Adhesiabloc, a product designed to reduce scar tissue after surgery.

As it turns out, there is no such product. Its developer, Device Med-Systems, does not exist. And neither, apparently, does Dr. Jonathan Q. Kruger, the Virginia doctor with a four-page curriculum vitae who was supposedly leading the research.

“The fraudulent trial was apparently commenced as part of a Congressional ‘sting’ operation,” Coast, which is based in Colorado Springs, said in its release.

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