EVEN THE OLD WALL STREET JOURNAL REPORTED ON THIS!
"Lawmakers have raised concerns over whether IRBs routinely approve medical studies for paying clients. The committee leaders are considering whether to introduce a bill to strengthen IRB regulations.
Two IRBs contacted by the GAO's sting operators -- Argus IRB of Arizona and Fox IRB of Illinois -- rejected the Adhesiabloc proposal because of unanswered safety questions.
"We realized it was a terrible risk for the patient … It is the worst thing I have ever seen," an Argus IRB reviewer said, according to a slide shown at the hearing.
Coast IRB LLC of Colorado Springs, Colo., did approve a study for the fictitious adhesive gel, "Adhesiabloc." Five months after approving the study for abdominal surgery patients, Coast learned that neither Adhesiabloc nor its maker, Device Med-Systems of Virginia, existed.
Coast CEO Dan Dueber said in an interview that the congressional case was illegal entrapment."
AND THEN, IT JUST DROPPED OFF THE RADAR WITH A SLAP ON THE WRIST BY THE FDA, WHO WAS THE ONE WHO ACTUALLY GOT STUNG!
WHY SPEND PUBLIC MONEY TO CONDUCT STINGS AND THEN NOT BOTHER TO PROSECUTE ANYBODY?
ALTHOUGH THIS STORY APPEARED BRIEFLY IN A FEW MAINSTREAM MEDIA NEWSPAPERS, BESIDES THE WALL STREET JOURNAL, I LIKE THE FOLLOWING ACCOUNT BEST:
"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.
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”.
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”.
BUT....APPROVAL DID COME!
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”.
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 Truper, after a three-legged dog, Trooper of a congressional staffer.
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 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. T
hey went into action.
They reported the fraud.
They ordered the immediate termination of the nonexistent trial.
And Dueber testified:
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. T
hey 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”.
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?
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."
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?”
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.
Instead of pulling power away from HHS, the FDA, and companies they’ve authorized, they’ve been given even more power.
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.
JUST IN THE PAST 20 YEARS THE FDA HAS BEEN ACCUSED OF AND FOUND GUILTY OF ABUSES AND FAILURES AGAIN AND AGAIN:
~Allegations that the FDA covered up exportation of unsafe products.
[Bogdanovich, Walt; Eric Koli (May 22, 2003). "2 Paths of Bayer Drug in 80's: Riskier One Steered Overseas". New York Times. ]
~ ~Allegations that unsafe drugs are approved. [David Graham's 2004 testimony to Congress, http://www.senate.gov/~finance/hearings/testimony/2004test/111804dgtest.pdf]
~Allegations that the FDA covered up exportation of unsafe products.
[Bogdanovich, Walt; Eric Koli (May 22, 2003). "2 Paths of Bayer Drug in 80's: Riskier One Steered Overseas". New York Times. ]
~ ~Allegations that unsafe drugs are approved. [David Graham's 2004 testimony to Congress, http://www.senate.gov/~finance/hearings/testimony/2004test/111804dgtest.pdf]
["The Cover-Up Artist". Slate. 2011-11-14. p. 1. http://www.slate.com/articles/health_and_science/medical_examiner/2011/11/sandusky_cover_up_why_is_kenneth_frazier_leading_the_investigation_at_penn_state_.html]
~ Allegations that unsafe food additives and processing technologies are approved.
~ Allegations that unsafe food additives and processing technologies are approved.
[ "Parents warned of additives link". BBC News. 2007-09-06. http://news.bbc.co.uk/1/hi/health/6979976.stm]
[ BBC Europe-wide food colour ban call April 10, 2008 http://news.bbc.co.uk/1/hi/health/7340426.stm]
~ Allegations of undue pharmaceutical industry influence. [Jennifer ross-nazzal. “From Farm to Fork”: How Space Food Standards Impacted the Food Industry and Changed Food Safety Standards page 226. NASA History Division. ]
~ Allegations of undue pharmaceutical industry influence. [Jennifer ross-nazzal. “From Farm to Fork”: How Space Food Standards Impacted the Food Industry and Changed Food Safety Standards page 226. NASA History Division. ]
[Ousted F.D.A. Chief Charges 'Pressure' From Drug Industry . New York Times.]
[ Data gaps in toxicity testing of chemicals allowed in food in the United States. http://www.sciencedirect.com/science/article/pii/S0890623813003298]
[Cauchon D: FDA advisers tied to industry. USA Today. September 25, 2001
[Stockton, Nick. Infoporn: Proof That the FDA Isn’t Protecting Americans’ Health (2015), Wired ]
~ Allegations regarding management and FDA scientists.
[Dying for FDA Reform PDF – June 2007 report from the Competitive Enterprise Institute. http://www.cei.org/pdf/5985.pdf]
GUILTY, AGAIN AND AGAIN, BUT STILL IN CHARGE OF ALL WE CONSUME!
IN 2012, THESE HEADLINES ABOUT A TOP 'DOG' AT THE FDA GRABBED VERY LITTLE ATTENTION :
IN 2012, THESE HEADLINES ABOUT A TOP 'DOG' AT THE FDA GRABBED VERY LITTLE ATTENTION :
"FDA Deputy Director arrested in prostitution sting scandal".
"A ranking Food and Drug Administration official is facing four counts of soliciting prostitution and a single count of disorderly conduct stemming from his arrest by Howard County, Md., Police last month."
YEAH, YEAH, WHO CARES, RIGHT?
THAT'S HIS PRIVATE BUSINESS...BUT PRIVATE LIVES LAP OVER INTO OFFICES WHEN SOMEONE HAS AN EXSPENSIVE "HABIT" AND NEEDS FUNDING FOR IT.
"According to spokeswoman Erica Jefferson. "Dr. Maisel is still employed by the agency and is working."
THAT'S NICE.
WE ALSO OBVIOUSLY DIDN'T CARE WHEN A LOT OF DEPARTMENT OF DEFENSE WORKERS GOT BUSTED FOR PARTICIPATION IN A CHILD PORNOGRAPHY RING.
THE DEFENSE DEPARTMENT'S ADDICTION SHOULDN'T SURPRISE ANYONE AS THEIR TOP GOVERNMENT CONTRACTORS HAVE BEEN ACCUSED OF AND PROVED TO HAVE BEEN DEALING IN HUMAN TRAFFICKING AS WELL AS SUPPORTING CHILD SEX RINGS MANY TIMES,
A FEW OF THOSE HAVE EVEN BEEN INDICTED FOR MURDER.
NO BIGGIE...IT'S OUR "UNCLE SAM'S" BOYS, YES?
OUR JUSTICE DEPARTMENT WAS BUSTED IN 2010 FOR A PFIZER RULING THAT SAW THE BIG DRUG COMPANY GET OF SCOT FREE AFTER BEING CAUGHT DRUG-DEALING!
"Last September, we reported “Pfizer slapped with $2.3 billion fine for illegally dealing drugs.” No one went to jail and Pfizer paid a tiny portion of its profits from illegally dealing Bextra from 2001 thru 2005. In 2005 alone, Pfizer made $1.7 billion on that drug. Now, CNN has revealed that the Department of Justice allowed Pfizer to set up a dummy corporation to take the rap, so that Pfizer could maintain its Medicare and Medicaid contracts.
On April 2nd, CNN reported, “when it came to prosecuting Pfizer for its fraudulent marketing, the pharmaceutical giant had a trump card: Just as the giant banks on Wall Street were deemed too big to fail, Pfizer was considered too big to nail.
“Why? Because any company convicted of a major health care fraud is automatically excluded from Medicare and Medicaid. Convicting Pfizer on Bextra would prevent the company from billing federal health programs for any of its products. It would be a corporate death sentence.”
“Prosecutors said that excluding Pfizer would most likely lead to Pfizer’s collapse, with collateral consequences: disrupting the flow of Pfizer products to Medicare and Medicaid recipients, causing the loss of jobs including those of Pfizer employees who were not involved in the fraud, and causing significant losses for Pfizer shareholders.”NOW YOU OR I WOULD HAVE GONE TO FEDERAL PRISON FOR THIS, BUT PFIZER DIDN'T, NOR HAVE OTHER DRUG COMP[ANIES CAUGHT DOING THE SAME THING!
"MORE PFIZER FRAUD REVEALED IN ITS GENETICALLY ENGINEERED AIDS-LIKE VIRUS PROGRAM"
In another stunning legal matter, Pfizer recently lost an employment claim when scientists became infected with a genetically-engineered AIDS-like virus, reports Raw Story. Pfizer supervisors threatened to falsify an employee’s reviews if she didn’t keep quiet about safety violations, eventually firing her.WHAT'S PFIZER UP TO TODAY?
WE DON'T KNOW!
OUR GOVERNMENT MAKES THE WORLD'S RENOWN MAFIAS LOOK LIKE SAINTS.
MASTER CRIMINALS SEEM TO BE IN HIGH DEMAND IN VERY HIGH PLACES.
LOOK AT THE "SHAKEUP" IN THE CIA AND THE FALL OF SOME OF THE PENTAGON'S BIGGEST NAMES...AND THE WHOLE SCENARIO REPLAYS AGAIN AND AGAIN.
BUT WHO CARES WHO'S IN CHARGE AND WHO CARES IF WE'RE SAFE FROM MEDICAL FRAUD SO BIG PHARMA CAN PROSPER, AND WHO CARES IF SICKOS ARE SITTING IN GOVERNMENT OFFICES LOOKING AT PHOTOS OF NUDE AND SEXUALLY ABUSED KIDS...OR IF THE FDA WOULD APPROVE HUMAN STUDIES ON A NONEXISTENT DRUG...OR...OR ANYTHING?
CRIMINAL AGENCIES NEED CRIMINALLY-MINDED STAFF, RIGHT?
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