Coast CEO is chided by congressional panel
Members of a congressional subcommittee ripped into the chief executive of a Colorado Springs company on Thursday.
The House Energy and Commerce Committee's Investigations and Oversight panel questioned Dan Dueber, chief executive of Springs-based Coast Independent Review Board, as part of an investigation into for-profit institutional review boards, which help ensure the safety of patients in medical tests.
Coast IRB was caught in a sting operation conducted by the Government Accountability Office in which GAO investigators set up a fake study of a fake medical procedure and submitted it to three IRB companies for review. Coast was the only one of the three to approve the trial, and several committee members found that troubling.
"The evidence suggests that Coast was more concerned with its bottom line than it was with patient safety," said subcommittee Chairman Rep. Bart Stupak, D-Mich.
Rep. Joe Barton, R-Texas, asked an official from the Food and Drug Administration if any regulatory actions could be taken to put Coast out of business.
"I'm so mad at the company I can hardly be civil," he said. "We ought to have their butt kicked out the door within the week."
Dueber, however, admitted no wrongdoing in the hearing and accused the GAO of fraud in pursuing its investigation.
"I can't believe my government did this to me and my company, and it's completely unconscionable," Dueber said in the hearing.
Dueber said Coast's review panel did nothing wrong in approving the trial.
"We had five doctors who said it was safe," he told the committee.
The sting began in September, shortly after Dueber took over at Coast, when the fake company, Device Med-Systems, sought approval of the rules under which its study of a fictitious product called Adheasiabloc would be completed. Coast's review board, which includes doctors and other medical professionals, approved the study's protocols in November.
Coast uncovered the fakery in March when the subcommittee asked Dueber to testify about the study. In reality, the fake company's address is a mail drop in a Virginia strip mall, and its medical director doesn't exist, nor does its product, which supposedly was to reduce scar tissue after surgery.
Coast supervises about 400 such studies at any one time and has reviewed between 4,000 and 5,000 such studies in its seven-year history, Dueber said. Federal rules do not require companies like Coast to audit every study, he said.
Committee members said that wasn't good enough, pointing to the two review firms that rejected the study.
"Two other IRBs both rejected our proposal out of hand," Stupak said. "Coast IRB approved the protocol unanimously, 7-0."
Dueber said Coast changed its procedures after learning of the fakery, and he said he was in favor of regulatory changes that would make it more difficult for companies to "shop" review boards in search of one that will approve their trials.
He said he invited the FDA to conduct a top-down review of Coast.
"We're in favor of improving the system and making it more difficult to do that because, obviously, that's not healthy," he said.
A representative for Coast said that Dueber was traveling after the hearing and was unavailable to comment.
Nick Choate, a spokesman for Stupak, said the IRB investigation is ongoing and several bills to improve IRB oversight are in the works.
The investigation came less than a year after Coast founder Darren McDaniel, who still owns the company, resigned as chief executive.
His resignation came after the FDA suspended Coast for two months from giving expedited approval of medical testing procedures. The agency suspended Coast amid allegations that the company violated federal rules in approving an advertisement for test subjects by a California firm.
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