A fake private medical review board, whose president was a dog named Trooper, recently registered its services with the U.S. Department of Health and Human Services, no questions asked, and was hired by a real research firm to certify that its clinic could safely test human beings, a top government investigator told a House hearing Thursday.

The bogus review board was part of a sting operation by the Government Accountability Office to determine whether these independent boards—and the federal government—are adequately protecting men and women enrolled in medical research. 

When GAO investigators informed HHS officials that they had registered a bogus review board run by a dog, they were told the department does not examine board registrations “to assess whether the information submitted is factual,” Gregory D. Kutz, the GAO’s managing director of special investigations, told the committee.

Investigators also created a fictitious new medical “gel” and asked three real for-profit review boards to certify the safety of a clinical trial to test the gel on women. One company, Coast Independent Review of Colorado Springs, Colo., unanimously certified the safety of the fake trial within a few days. Two others rejected it, saying the trial was “a terrible risk for the patient” and “the worst thing I have ever seen.”

The trial called for pouring a full liter of liquid containing the gel into a woman’s abdominal cavity after surgery. A check would have revealed the fake gel was modeled on a real one that was ultimately withdrawn from the market because it caused deaths and infections among patients. A check would have also revealed that the trial was to be carried out by phony doctors at an address that turned out to be strip mall in Virginia.

The GAO’s findings raise serious questions about “the entire system for approving experimental testing on human beings,” said Rep. Bart Stupak, D-Mich., chairman of the Subcommittee on Oversight and Investigations within the House Energy and Commerce Committee. “The results are not reassuring.”

Approximately 10 million people in the United States are involved in clinical trials to test drugs and medical devices. The pressure to bring new drugs and devices to market so far outstrips the capacity of even thousands of institutional review boards at hospitals, universities and medical centers that these private for-profit boards now play a key role in overseeing patient safety, experts say.

By law, companies receiving federal funds or firms that hope to have their drugs or devices approved for sale by the Food and Drug Administration must get an independent review board (IRB) to approve the safety of their human trials.

“Our investigation shows that the IRB system is vulnerable to unethical manipulation,” said Kutz of the GAO. The holes in the system, he said, increase the risk that “experimental products are approved for human testing with little or no substantive due diligence.”

Kutz said that throughout the investigation, which ran from the fall of 2008 to this month, all communication with the boards was through faxes and the Internet. Investigators never had face-to-face meetings, on-site inspections or even telephone calls that might have exposed their ruse.

From 50 to 100 private firms in the United States, operating under FDA rules, are paid by drug companies to monitor safety protocols in trials they hope will lead to FDA approval. But critics contend those boards are for-profit, and the only way they can make money is to approve the trials—a built-in conflict of interest.

Daniel Dueber, president of Coast, complained to the committee that the investigation was a “fraud against my company.” But he did say that Coast planned to institute new safeguards and more checks.

Officials from the FDA and HHS testified at the hearing but refused to say what if any sanctions they would level against Coast for its approval of the bogus trial.

“So what will you do about this company?” asked committee member Joe Barton, R-Texas.

“We will take the GAO investigation and evaluate it,” said the FDA official.

Barton said the federal officials appeared to be “almost indifferent,” while the Coast company president “is incensed we are even asking the questions or doing the investigation.”

(Photo: The House Energy and Commerce Committee)

Barbara Basler is a senior editor at the AARP Bulletin.