NOT THE SHARPEST KNIVES IN THE DRAWER: Fake Product Gets Thumbs Up For Taxpayer-Funded Human Trial
In a sting operation aimed at exposing shoddy screening and rubber-stamping of federally funded clinical trial protocols, the Government Accountability Office shopped a bogus study proposal to test a surgical adhesive gel to several for-profit institutional review boards until it found one that gave it the green light, and registered its own phony IRB using a form posted on the Department of Health and Human Services Web site, reports The Wall Street Journal:
Two IRBs contacted by the GAO's sting operators - Argus IRB of Arizona and Fox IRB of Illinois - rejected the Adhesiabloc proposal because of unanswered safety questions. …
Coast IRB LLC of Colorado Springs, Colo., did approve a study for the fictitious adhesive gel, "Adhesiabloc." Five months after approving the study for abdominal surgery patients, Coast learned that neither Adhesiabloc nor its maker, Device Med-Systems of Virginia, existed.
At a House Energy and Commerce Committee hearing about the sting, Coast IRB, LLC complained of entrapment, and “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,” reports The Associated Press:
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." …
"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."
HHS was also on the receiving end of ridicule for certifying an IRB with a CEO named Truper Dawg, and other key personnel named "April Phuls" and "Timothy Wittless" without checking it out.
[Hat Tip: The Heel, an Ivy-educated attorney with a prestigious New York firm, and occasional contributor to this blog.]
Comments