Government investigators looking into lax screening of medical research said Thursday they easily won approval from a private 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 review board was a dog named Trooper.
The GAO said its investigation showed that they system “is vulnerable to unethical manipulation, particularly by companies or individuals who intend to abuse the system or to commit fraud.”
Rep. Bart Stupak, D-Mich., chairman of the House Energy and Commerce Committee’s oversight and investigations panel, said the findings “raise serious questions” about both the specific IRB 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 that 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 officer.
“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.” (read the rest here)