Drug Study Overseer Gets Studied in Sting Operation

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Filed under: Fraud and Deception

Testing Firm Finds Itself Being Tested
by Barry Meier
The New York Times
March 13, 2009

rep-bart-stupakLike 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.

The company\”™s president, Daniel Dueber, said he believed the operation was an unwarranted effort by the House Energy and Commerce Committee\”™s Subcommittee on Investigations and Oversight to embarrass firms like his. The subcommittee, whose chairman is Bart Stupak, Democrat of Michigan, has been investigating companies and others that monitor the safety of patients in medical studies.

Critics contend that too many of the companies in that business may be slipshod in monitoring trials because they do not want to alienate the companies that pay them, a contention that officials like Mr. Dueber rejects.

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