GAO team wins approval for fake medical product
Fictitious review board also OK'd in screening probe
WASHINGTON - Government investigators looking into lax screening of medical research said yesterday they easily won approval from a private independent review board of a fake product to be used in medical testing on human subjects.
The Government Accountability Office also said it was able to register with the Health and Human Services Department a fictitious institutional review board, a panel of doctors and scientists that must approve any medical drug or device to be used in federally funded testing on humans. The president of this fake board was a dog named Trooper.
The GAO said its investigation showed the system "is vulnerable to unethical manipulation, particularly by companies or individuals who intend to abuse the system or to commit fraud."
Representative Bart Stupak, a Michigan Democrat and chairman of the House Energy and Commerce Committee's oversight and investigations panel, said the findings "raise serious questions" about both the specific board that approved the fake product and "the entire system for approving experimental testing on human beings."
Officials from HHS and the Food and Drug Administration assured lawmakers there were substantial protections in place to ensure that testing is done in a responsible and ethical manner.
The review board that fell for the GAO ruse, Coast IRB LLC, of Colorado Springs, charged that the GAO violated federal and state criminal laws by falsely representing itself to be a medical device company and forging a medical license. "We got hoodwinked," said Daniel Dueber, Coast IRB's chief executive.
"You didn't get hoodwinked," Stupak replied. "You took the bait - hook, line, and sinker."
According to the GAO, two independent review boards rejected the fake medical protocol, which called for a full liter of a fictitious product to be poured into a woman's stomach after surgery. An employee of one called it "junk" while a board member of another said it was the "riskiest thing I've ever seen on this board."
But Coast IRB approved it unanimously and minutes of the meeting obtained by GAO showed that board members thought the bogus protocol was "probably very safe."
Stupak also questioned whether the investigation revealed a tendency of "IRB shopping," where clinical researchers choose the review boards based on how quickly and inexpensively they approve studies.
The GAO said it also registered its own fictitious IRB with HHS using an online registration form. It ran ads for its "HHS-approved" IRB with emphasis on the speed of its review process. A research coordinator who responded to the ads said it was because of the low price and quick turnaround time.
Dr. Jerry Menikoff, director of HHS's Office for Human Research Protections, told lawmakers the registration process does not mean the HHS is giving a stamp of approval to a review board. "Right now we think we have a well-functioning system," he said, adding that there was room for improvement.