FDA BUSTED: Sting Operation found FDA Approved Nonexistent Drug from a Nonexistent Firm

This is from Jan 2011 - so maybe this is old news from some.  I just found this and just had to post it just in case.

FDA System Approves Nonexistent Product from Nonexistent Company for Human Testing

by Heidi Stevenson 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, 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.

The 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. 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 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. 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, 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 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.

Commentary from Health Freedom Alliance:

The FDA describes themselves as being in place to protect the American public. Most people these days know better, especially when reports like the following display to citizens the sort of malicious folly carried out on the daily by the agency. In stings set up by Congress with the General Accountability Office (GAO), the FDA displayed its lack of attention to obvious dangers and fraud by approving medical testing for a ridiculous device and approving a company with laughingly phony names as one of its Institutional Review Boards (IRBs) which are the for-profit companies that really do the testing of products.

The medical device that was approved by one of these established IRBs of the FDA? Adhesiabloc was presented by a nonexistent company, Device Med-Systems, and 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. Even though there was no record of the company and the doctor who was supposed to be leading development was fake, the item was approved to be tested on humans.

Yikes, and now the FDA is poised to gain more money and power with legislation passed by the current administration. Where is the line drawn when it comes to gross neglect of duties? Why is the administration, instead of going through an intensive review process, allowed even more jurisdiction over the health of the American people when they have already been clearly neglecting their proposed responsibilities?

~Health Freedoms

Views: 123

Comment

You need to be a member of 12160 Social Network to add comments!

Join 12160 Social Network

"Destroying the New World Order"

TOP CONTENT THIS WEEK

THANK YOU FOR SUPPORTING THE SITE!

mobile page

12160.info/m

12160 Administrators

 

Latest Activity

Doc Vega's 4 blog posts were featured
4 hours ago
Burbia's blog post was featured

Charlie Kirk Assassination

September 10th 2025 in Utah Turning Point USA CEO has been assassinated. Coincidentally,  answering…See More
4 hours ago
Charles Magus's blog post was featured

FURTHER PROOF OF WALK-INS! Prisoners of the Dulce Base by Sherry Shriner

There is a real connection between the Cabal and what is happening at this Undergroung…See More
4 hours ago
Less Prone favorited Doc Vega's blog post Ashrams and Moonies Perfect Case for Mind Control
4 hours ago
Less Prone commented on tjdavis's blog post Sentient World Simulation
"Cannot open the link"
4 hours ago
Tina Sullivan is now a member of 12160 Social Network
10 hours ago
Doc Vega posted blog posts
20 hours ago
Sandy posted a video

We’re cooked

We’re cooked
22 hours ago
Sandy posted a photo
23 hours ago
tjdavis posted a video

Tom Horn discusses Masonic view of 2025

Startling perspective by Tom Horn of the upcoming year: 2025
yesterday
cheeki kea posted a photo
Tuesday
cheeki kea commented on Doc Vega's blog post Grooming the New Generation of Assassins
"It's a distressing state of affairs when evil leftists hardwire impressionable students and…"
Tuesday
Doc Vega commented on Doc Vega's blog post This Memorable Anthem Given by Nick Freitas Hit the Nail on the Head Please Listen!
"Burbia Charlie Kirk's wife is a real firebrand! God bless that poor woman! "
Monday
Doc Vega commented on Doc Vega's blog post This Memorable Anthem Given by Nick Freitas Hit the Nail on the Head Please Listen!
"Burbia thanks for the videos! "
Monday
Doc Vega posted blog posts
Monday
Burbia commented on tjdavis's video
Thumbnail

Charlie Kirk: Grief And Outrage From Turning Point USA in Phoenix

"Early reports said a.second shooter was there. Talk of Dischord chats. Peyton Gendron was coerced…"
Monday
tjdavis posted a video

America In Crisis: Illegals and Drug Smugglers Have Us Beat

An inside look at how bad the situation is at the Arizona/Mexico border. This exclusive tour with retired Arizona Sheriff Mark Lamb reveals just how bad thin...
Monday
Burbia posted a video

Sam Hyde Show: This is You

support the show: https://www.mde.tv/▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬🔥 BUY EXTREME PEACE on MDE.TV 🔥https://www.mde.tv/series/extreme-peace▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬▬...
Monday
Burbia commented on Sandy's photo
Monday
Burbia commented on Sandy's photo
Monday

© 2025   Created by truth.   Powered by

Badges  |  Report an Issue  |  Terms of Service

content and site copyright 12160.info 2007-2019 - all rights reserved. unless otherwise noted