Fake Medical Product Gets Approval for Testing
The Government Accountability Office in a sting operation found lax screening by review boards and this would now result in stricter regulations for medical research groups that monitor clinical trials.
Details of the sting operation were detailed at a House Energy and Commerce Committee hearing Thursday and GAO said it was able to register a fictitious company as well as a fake medical device, a surgical gel and apply to three institutional review boards or IRBs for approval to begin testing the adhesive on human subjects.
GAO said they were able to register a fictitious institutional review board whose president was a dog named Trooper with the Health and Human Services Department. 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."
As per rules drug and device makers along with hospitals and university research facilities must retain an independent IRB to oversee the methodology and safety issues for human studies. Food and Drug Administration approval for products is not given without an IRB certifying their clinical trials. There are approximately 6,350 IRBs registered with the Department of Health and Human Services.
There have been concerns about whether IRBs approving medical studies for clients who pay and committee leaders are toying with the idea of introducing a bill to strengthen IRB regulations.
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."
According to the GAO, the fake medical protocol, which involved a full liter of a fictitious product to be poured into a woman's stomach after surgery, was rejected by two independent review boards Argus IRB of Arizona and Fox IRB of Illinois. 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."
The third review board, Coast IRB LLC of Colorado Springs, Colo., approved a study for the fictitious adhesive gel. Coast IRB charged that 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."
Dueber said his company was taken in because they had "never had the experience of having a fraudulent group lying to us about their existences and about their licenses." He said the company has since changed its operating procedures.
At the hearing, Mr. Dueber testified, "The GAO perpetrated an extensive fraud against my company. You pulled the wool over our eyes -- congratulations."
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.
Dr. Jerry Menikoff, director of HHS's Office for Human Research Protections said, "Right now we think we have a well-functioning system," he said, adding that there was room for improvement. He added that his bureau had only recently received the committee information about Coast, and would look into the matter.
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