COTO Report - FDA System Approves Nonexistent Product from Nonexistent Company for Human Testing

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FDA System Approves Nonexistent Product from Nonexistent Company for

Human Testing

January 15, 2011 @ 9:07 pm › laudyms

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by Heidi son 10 January 2011          gaia-health

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,

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,â€

and an employee of the other simply called it “junkâ€.

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 safeâ€.

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, Witless, and Alan Ruse. The company’s

location was listed as Chetesville, Arizona.

The application sailed through.

The Response

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. They went

into action. They reported the fraud. They ordered the immediate termination of

the nonexistent trial. And Dueber testified:

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.

Right.

Dueber went on the aggressive, 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

credentiallingâ€.

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.â€

Representative Bart Stupak of Michigan responded, “You didn’t get

hoodwinked. You took the bait, hook, line, and sinker.â€

The FDA never moved against Coast. However, the good news is that the company

didn’t survive. Their business dried up.

Regarding the sting again 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, 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?â€

The saddest part of this tale is that none of this is news. This happened nearly

two years ago. Nothing has been done to resolve an obviously corrupt system. The

stings revealed an obvious and 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 customers, health 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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