Thursday, September 20, 2012

FDA System Approves Human Testing for Nonexistent Product and Company

© Gaia Health Blog
FDA System Approves Human Testing for Nonexistent Product and Company
Sept 20, 2012 | Heidi Stevenson

A sting nailed a company that Health and Human Services had 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 never noticed.

The FDA farms out drug and medical device testing. It’s in the hands of the companies hoping to gain approval for their products. Overview, though, is required. Study plans must first be approved before testing can proceed on humans.

However, the FDA doesn’t review the testing plans. That’s done by for-profit companies called Institutional Review Boards (IRBs).

Who do you suppose pays the IRBs? The corporations hoping to gain FDA approval for their products, of course!

It’s a conflict of interest on top of a conflict of interest.

The First Sting

Congress became suspicious of the IRB system, 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 person 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”.

However, 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”.

That’s right. Coast IRB had no problem approving a product described as mopping up after stomach surgeries by pouring at least a liter into the wound to collect left over bits and pieces.

Coast IRB’s Response

Daniel Dueber, Coast IRB’s CEO, was subpoenaed to testify to Congress. That must have clued him in that something might be wrong. Apparently, he or someone else in his company went through their files to search for irregularities. Adhesiabloc popped out. Oops! This was five months after the approval. So, they went into action. They reported the fraud. They ordered immediate termination of the nonexistent trial. And Dueber testified before Congress:
We are doing our level best to ensure protection for subjects of clinical trials under our review, an objective we share with the Food and Drug Administration. We are legally and morally obliged to report any unlawful conduct we find occurring in a clinical trial and, so, fulfilled that responsibility in this case.

Dueber went on the attack, saying that sting operations are illegal unless they’re approved by the courts. He went into high dudgeon, playing the poor innocent. He claimed that congressional investigators had “perpetrated an extensive fraud against my company.” Coast IRB further stated that they were “violating wire fraud, mail fraud, and state laws against fraud and false credentialling”.

Ummm … Exactly what was Coast doing? Wasn’t that fraud? And on a much grander scale—one that can result in the deaths of huge numbers, like Vioxx, and Avastin, and Hormone Replacement Therapy, and so many others.

Finally, he told the congressional committee, “We got hoodwinked.” Representative Bart Stupak of Michigan responded, “You didn’t get hoodwinked. You took the bait, hook, line, and sinker.”

The FDA never moved against Coast. Fortunately, the company didn’t survive. Their business dried up. It does, though, leave you wondering who has stepped into Coast’s shoes, doesn’t it? If a company can do something that blatant—and that stupid—yet not have any criminal charges levied against any of the guilty parties—it’s hard to believe that some other unscrupulous players haven’t stepped into the breach.

A Second Sting

You have to wonder how an IRB as sloppy as Coast was licensed in the first place. The GAO did a second sting that shows us. It targeted the Department of Health and Human Services (HHS) itself—the parent of the FDA.

The GAO 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.

What Was the Point of the Stings?

Regarding the sting against HHS, Congressman Greg Walden of Oregon was displeased, and on the day of the inquiry, stated, “Nobody picked up on names like Phake Medical Devices, April Phuls, Timothy Witless and Alan Ruse—in the town of Chetesville, Arizona?” Representative Joe Barton of Texas exclaimed to an HHS official, “Do you have any sense of outrage?”

The saddest part of this tale is that none of it is news. This happened over three years ago. Nothing has been done to resolve this obviously corrupt system. The stings revealed an utter lack of concern for the quality, safety, and efficacy of drugs and medical products by the agencies tasked with overseeing them.

Not a single step has been taken to safeguard the public. Not even lip service has been paid.

In fact, the opposite has happened. Instead of pulling power away from HHS, the FDA, and companies they’ve authorized, they’ve been given even more power. And they’ve used that power recklessly against innocents and healthy products, such as raw milk producers and their customershealth food products and stores, and other healthy products, like walnuts. They’re doing this while allowing more and more truly dangerous and useless products to continue to be produced and sold by those who hold the real power over them: Big Pharma and Big Medicine.

The FDA supports the profits of Big Pharma and Big Medicine over the rights and health of the people.

HHS supports the profits of Big Pharma and Big Medicine over the rights and health of the people.

Other than a little showboating, Congress supports the profits of Big Pharma and Big Medicine over the rights and health of the people.


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