By Heidi Stevenson
A sting nailed a company the HHS authorized to oversee human drug trials. The absurdities in the application are belly laugh funny, but in their rush to keep the money coming, they approved it.
The FDA farms out drug and medical device testing. It’s in the hands of the companies hoping to gain approval for their products, but they must first get approval before doing tests on humans. Even here, though, there’s a catch. The FDA doesn’t review the testing plans. That’s done by more for-profit companies, Institutional Review Boards (IRBs). But it gets worse. The IRBs are paid by the companies hoping to gain FDA approval for their products. So, it’s a conflict of interest on top of a conflict of interest.
The First Sting
Congress became suspicious, so they got together with the General Accountability Office (GAO) to set up a sting. They sent out an application for testing of a nonexistent product, Adhesiabloc, by a nonexistent company, Device Med-Systems.
Subtlety is apparently not one of the GAO’s strong suits. Adhesiabloc was described as a gel that would be poured into a patient’s stomach after surgery to collect the bits and pieces left over from the operation. The instructions were to pour more than a liter into the wound.
Not one of the IRBs bothered to check the credentials of Device Med-Systems. Not one noted that the company’s headquarters was listed as a post office box in a shopping mall. The doctor who was supposed to have been leading development, Jonathan Q. Kruger, didn’t exist either. Not one checked to see if the product had ever been registered in development. Even so, two of the IRBs turned them down. Apparently, they actually read the testing protocol. The board member of one stated that it was the “riskiest thing I’ve ever seen on this board,” and an employee of the other simply called it “junk”.
Coast IRB LLC of Colorado Springs apparently didn’t see any value in reading the documentation. Their board members, several of whom were MDs, approved it unanimously, describing it as “probably very safe”.
The Second Sting
If that isn’t bad enough, the GAO did a second sting—and this one was on the Department of Health and Human Services (HHS), the parent of the FDA.
You have to wonder how an IRB as sloppy as Coast was licensed in the first place. This sting shows us. They put together an application to set up an IRB and sent it to HHS. They named their sting Trooper, after a three-legged dog of a congressional staffer. (Some reports state that the company name or the CEO was Trooper, but that doesn’t fit the scheme, as you’ll see.)
The name of the fake company was Phake Medical Devices. The names of the principals were April Phuls,Timothy Witless, and Alan Ruse. The company’s location was listed as Chetesville, Arizona.
The application sailed through.
Read full post at gaia-health