Healthy Skepticism Library item: 15343

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Publication type: news

Meier B.
Testing Firm Finds Itself Being Tested
The New York Times 2009 Mar 12
http://www.nytimes.com/2009/03/13/business/13sting.html

Full text:

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.

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.

“They want to come out of this grandstanding” he said, referring to the House subcommittee.

Nick Choate, a spokesman for Mr. Stupak, declined to comment on the inquiry. But he said that Coast would be part of a hearing later this month, and “all the facts related to this investigation will be discussed at that time.”

The undercover investigation of the trial industry was conducted by the Government Accountability Office, a research arm of Congress, at the subcommittee’s request, a G.A.O. spokesman said.

Medical experts say that companies that oversee clinical trials need, at the very least, to be familiar with the sponsors of the trials and to ensure that the doctors are qualified to conduct them and are in good standing with state medical boards.

As for Coast, its due diligence seems to have started late.

In a telephone interview, Mr. Dueber said his firm began investigating the bona fides of the Adhesiabloc study last week – five months after it gave Device Med-Systems approval to begin its clinical trial. Prompting that credential check was a letter from Mr. Stupak’s panel inviting Mr. Dueber to Washington to testify about the study.

In the days since, Mr. Dueber said the company discovered that the address given for Device Med-Systems, the site where the study was supposed to be conducted, was a store that rents mail boxes in a strip mall in Clifton, Va. He also learned that the Virginia medical licenses of the physicians involved in the study were fake, including the one for the principal investigator, Dr. Kruger. (There is an ophthalmologist named Dr. Jonathan P. Kruger who is licensed in Virginia; he could not be reached for comment on Thursday.)

Asked why Coast had not undertaken those background checks when it agreed last October to monitor the study, Mr. Dueber said it never occurred to him that anyone would develop a study that was not real.

He added that the only issue raised in October by Coast’s medical board, which includes several real doctors, was a request for revisions in the study’s patient consent form. A Coast official, he said, had spoken by phone with the supposed head of Device Med-Systems, who identified himself as Paul Jennings and agreed to make the requested changes. “It was very congenial,” Mr. Dueber said.

He said that Coast had followed all federal rules in approving the Adhesiabloc study, but that the company had now revised its own policies.

As for the undercover investigation, signs of it were still visible on Thursday. The Web site for Device Med-Systems was still operating, as was a telephone number for the company.

Calls placed to Dr. Jonathan Q. Kruger and Paul Jennings at the number listed for Device Med-Systems were not returned.