Housecalls with Dr. William Ferril
April 30, 2009
Dangerous fake product gets approved for research
This is going to sound like a joke, but I don't think you're going to laugh at the punch line.
Government investigators recently were able to get a fake and potentially dangerous procedure approved for human testing. And then they were able to register a phony institutional review board with a dog named Trooper as its president.
That's right. This joke's on you.
These review boards approve drugs and procedures for use in federally funded human tests. It turns out some of them are indeed a joke, and not just the one with the dog in charge.
Many review boards have been tied to universities and medical institutions in the past, but a growing number have turned this process into a for-profit operation. It seems all you need to do is file some paperwork with the Department of Health and Human Services, and you're in business.
Members of these review boards are generally doctors and scientists, but that alone doesn't always stop them from making bad decisions.
Investigators working for the Government Accountability Office came up with a ridiculous and clearly fake scenario that involved pumping a liter of "Adhesiabloc," a nonexistent gel, into a woman's stomach after surgery to see if it would help reduce scar tissue.
The trial was designed to match what the Food and Drug Administration considers a significant risk.
That didn't seem to be a problem for a review board from Colorado Springs, who essentially told them to go ahead and try it out.
The head of that organization claims they were "hoodwinked" and accused the investigators of violating laws when they misrepresented themselves. That's a little like a burglar calling the trapdoor that caught him unfair and deceptive.
Somehow, two other independent review boards managed to see the procedure for what it was and rejected it. One called it "junk," while a member of the other called it "the riskiest thing I've ever seen."
And that's one of the many, many problems with the process. You may be trying to push risky junk through the system, but you can keep on pushing until you find someone willing to sign off on it.
Officials from both the FDA and the Department of Health and Human Services were quick to defend the system. They say there are protections in place to make sure drug testing is done right.
But who can believe them now?
The stomach-gel procedure will obviously never be attempted despite the approval to do so. But the million-dollar question now is what potentially dangerous products have made it through these independent review boards and are being tested on humans right now?