A Frisbee-chasing, three-legged German shepherd named Trooper played a starring role at a congressional hearing Thursday, but not for the usual canine tricks. Instead, the dog was something of a hero, a key player in a yearlong sting operation set up by the Government Accountability Office to catch lax health regulators in the act.
Trooper went undercover last year as "Mr. Trouper Daug," the fake CEO of a fake "institutional review board" or IRB. The GAO has been worried for some time about the unsupervised rise of commercial IRBs.
These are companies that hire doctors and scientists to review and evaluate the testing methods of a drug or device that's being tested in humans. In contrast, in the hospitals and university medical schools where most medical research is conducted, the members of these panels are volunteers and governed by tighter guidelines. The safety of academic IRBs was not in question at the hearing.
Under the dog's name, GAO investigators were able to register the fake company with the Department of Health and Human Services. The fake firm even successfully used that registration as a marketing tool, luring companies eager to test new drugs by touting its review services as cheap and quick. No regulator from HHS ever checked out the legitimacy of the company in any way.
In another part of the sting, the GAO submitted paperwork to three commercial IRBs for a made-up drug, using a fake medical license, fake mailing address, and incomplete characterization of the drug. According to the study design, the researchers were to pour the drug into the abdominal cavities of women "to aid healing."
Two of the commercial IRBs dismissed the proposal out of hand. But one company, Coast IRB, of Colorado Springs, Colo., OK'd the fake study.
"GAO's findings raise serious questions," said Rep. Bart Stupak (D-MI), chairman of the House Energy and Commerce Committee's oversight and investigations panel. "Not only about the specific IRB involved in this investigation, but with the entire system for approving experimental testing in human beings."
The head of Coast IRB told those gathered at the hearing that his company had been hoodwinked by the GAO investigators.
"You didn't get hoodwinked," Stupak said. "You took the bait hook, line and sinker."
Dr. Jerry Minikoff, director of the HHS's Office for Human Research Protections, told Stupak and his colleagues that his office is currently not responsible for evaluating IRBs; it just maintains the list of companies that register. New, tighter regulations administered by the Food and Drug Administration will go into effect this July.
As for Trooper? The CEO shepherd — a pet of a former congressional committee staffer — died last month of natural causes.
By NPR staff
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