Sting on FDA Demonstrates Its Corruption

by Heidi Stevenson

16 September 2009
Note: This article is a rerun.

If the FDA ever existed for the benefit of the people, that time has long passed. A congressional sting demonstrates the malfeasance that places every person who could be subjected to drugs or devices wielded by the medical system at grave risk.

Device Med Systems, a fictitious company, applied for approval to run a trial for Adhesiabloc, which was described as a post-surgical device for healing women after abdominal surgery by pouring a full liter of it into the incision. Device Med Systems sought approval from three IRBs (institutional review boards), independent, for-profit, and obviously unsupervised companies authorized by the FDA to review and supervise drug and medical appliance trials. Two of the three turned them down, but one, Coast IRB, LLC, of Colorado Springs, approved the trial.

In a clear indication that Coast exists only for its own profits, its board unanimously approved the trial. Minutes of that meeting document that they determined the trial protocol was "probably very safe". The other two IRBs called it "junk" and the "riskiest thing I've ever seen on this board."

The sting, operated by the GAO, is a clear demonstration of the utter corruption of the agency that has been entrusted with monitoring the US's medical products industries.

Daniel Dueber, Coast's CEO, complained that his company was "hoodwinked", that they had "never had the experience of having a fraudulent group lying to us about their existences and about their licenses." He even suggested that the GAO had violated state and federal criminal laws in perpetrating the sting. Testifying at a congressional hearing, he self-righteously stated, "Mr Chairman, the question confronting me, and which I hope will occur to you, is whether this Committee and the GAO have lawful authority to defraud an innocent party to prove a political point." It didn't even occur to him that it was his job to protect the public from such fraud, and that he had failed miserably.

Dueber claims that his company has changed its procedures—but that begs the question of why the FDA lets it stay in business.

The story just gets worse. The researchers for a proposed trial are required to give assurances in writing, stating that they'll abide by federal regulations and ethical principles. None of the researchers existed.

Not only did the GAO create a fake research company, it also created fake IRBs, called Phaké Med Devices and E-Z Reviews. E-Z's address was listed as 1234 Phulovit Lane SE, Chetesville, and staff members were name April Phuls, Timothy Wittless and Alan Ruse. [Congressional stings apparently have no need for subtlety!]

E-Z Reviews had a website and advertised in newspapers, with a focus on flexibility and review speed. At least one company opted to apply, looking to gain approval for one of its clinics to do clinical trials for invasive surgery. The outcome of this incident is unknown.

The OHRP—Office for Human Research Protection, a department of Health and Human Services (HHS)—doesn't review IRB registrations or assurance applications, though it is tasked to do so. Though good work may be done by some IRBs, there is little or no oversight in the entire process of drug and medical appliance approval.

How much phony research is being done? How many drugs and medical devices are approved through this process? How many unscrupulous people who do not care that their products may be killers are allowed access to this system? How many approvals are given for deadly products? How many people are maimed and killed?

The FDA is failing utterly in its primary duty to protect the public from dangerous medical products. It's absolutely clear that its allegiance belongs to profit-making corporations, not to the people it's commissioned to defend. It is now pushing to take over control of regulation of foods and supplements as if they were drugs. That, in fact, seems to be its primary goal. What reason could possibly exist other than to protect the pharmaceutical corporations that feed it money and provide wealth to employees who play along, whether through outright bribes or speaking fees or high-salaried positions on leaving the FDA?

There's a stench emanating from the FDA. How many more Vioxxes are we willing to accept?