This happened in March not today on April 1st. But this seems the best day to report it.
There are many naïve people who really believe that government health services and institutions do actually work for the benefit of the public, as their names would indicate.
Anyone investigating the work of the Federal Drug Administration, (FDA) which is obviously a lackey of the pharmaceutical industry would find that out at once. But occasionally the professional deceivers of the public get shown up very clearly for how incompetent and untrustworthy they really are. And this incident makes anyone with more than a single digit IQ wonder how they stay in office.
Whenever a new drug or a new medical device is invented or discovered by some organization it has to be reviewed by an Independent Review Board (IRB). This is supposed to be an organization that is independent of the inventors and will give an unbiased review of the new thing.
Drug and device makers along with hospitals and university research facilities must retain an IRB to oversee the methodology and safety issues for human studies. Corporations cannot get FDA approval for their products unless an IRB certifies their clinical trials.
The IRB’s are registered with the Department of Health and Human Services (HHS), which monitors which IRBs are good enough for the job. This two step process is allegedly there to ensure that everything that can be done to ensure the effectiveness of the new treatment or device has been done.’For your protection,’ as the secret police vans say in V for Vendetta.
There is actually a government institution that does honest work. It is the Government Accountability Office (GAO) and the people in this group have often found out how astonishing are some of the things that go on in the name of public service. But this one wins a prize.
The GAO were interested on the reliability of the chain: Inventors to IRB to HHS to FDA. So they registered a completely fictitious review board (IRB) with the HHS.
Now we all know that politicians never read the Acts they vote on before they vote. Nobody read the 700 or so pages of the Patriot Act for example. But they voted for it. And we know that forms designed by government offices are often impossible to fill out if your native language is English and not officialese.
To register a review board with the HHS requires a great deal of skilled form filling and attachments of required data concerning the qualifications of the professionals of the IRB. The GAO people of course live in the world of officialese and filled in the forms perfectly. But to ensure that ANYONE with a single digit IQ would be suspicious of it they gave the name of the president of this new IRB as ‘Truper Dawg.’ That was accepted. Some other officials of this IRB were named as ‘April Phuls’ and ‘Timothy Wittless.’ These caused no problem probably because all the spaces in the forms were filled in.
The president was named after a real, three legged, pet dog of a GAO staffer. It had died some time back. This seemed a good way apparently to ensure continuation of the name. But wouldn’t you have felt a little insecure at granting possible life or death decisions to a review board with those cartoon names? I bet if they were on a voting list someone would ask questions.
Well, that invented IRB was to test how difficult it was to be registered by HHS. Not very difficult apparently for a skilled form filler.
At the same time the GAO also invented a device company and its fictitious medical product named Adhesiabloc. This was supposed to be an adhesive gel that was poured into the patient after stomach surgery and had the effect of sticking together any loose bits and pieces from the operation. A sort of universal grout for any patterns of incisions, and scar tissue. The procedure involved pouring over a quart of this gel into the stomach of the patient.
The GAO used this totally absurd invention to test the reliability of three FDA approved IRBs. They asked the three IRB’s to initiate a clinical trial of this medical marvel and its effect on human patients. The IRB that took the bait was Coast IRB, LLC of Colorado Springs. Don’t forget that a medical review company is supposed to notice anything odd in an application for a clinical trial. They are our stalwart defenders against quackery. Ha ha. There are currently 6,300 of these IRBs that certify drug trials and medical device trials for the FDA to consider.
So, what value is an “FDA-approved device or drug when you know that in this land of experts the Department of Health and Human Services will certify a totally fictitious IRB that stated it was headed by a dog. Don't ask.
That’s one in three of the IRBs tested that took the whole thing in as fact. Apparently they never ever considered that a company might have them try out something that made no medical sense. It’s rather like having a police force of people who cannot, or are not allowed to think that some people are dishonest, or breakers of the law.
Oversight of medical devices in America has been shown by the GAO to be a travesty. If you know how to fill in the paper work you could get anything through the system somewhere.
It’s pretty clear that some IRBs will routinely approve medical studies for clients with ready cash. Two honest, or at least competent IRBs contacted by the GAO's sting operators -- Argus IRB of Arizona and Fox IRB of Illinois rejected the Adhesiabloc proposal because of some perceived safety issues.
But Coast IRB LLC of Colorado Springs, Colo., did approve a study for the fictitious adhesive gel, Adhesiabloc. It took five months after approving the study for abdominal surgery patients before Coast found out that neither Adhesiabloc nor its maker, Device Med-Systems of Virginia, existed. And they didn’t start looking into it until they were invited to a hearing.
According to the GAO, the two IRB’s mentioned above rejected the fake medical protocol, which called for a full liter of a fictitious product to be poured into a woman's stomach after surgery. An employee of one called it "junk" while a board member of another said it was the "riskiest thing I've ever seen on this board." Apparently they read the protocol.
But the Coast IRB board approved it unanimously and minutes of the meeting obtained by GAO showed that board members, who included several MD’s, thought the protocol was "probably very safe."
The GAO said its investigation showed that the current system "is vulnerable to unethical manipulation, particularly by companies or individuals who intend to abuse the system or to commit fraud." Maybe they had bankers in mind.
Rep. Bart Stupak, D-Mich., chairman of the House Energy and Commerce Committee's oversight and investigations panel, said the findings "raise serious questions" about both the specific IRB that approved the fake product and "the entire system for approving experimental testing on human beings." That seems to be an understatement.
At the hearing in March, the toughest complaints were reserved for HHS. Rep. Joe Barton of Texas, the committee's ranking Republican, asked one HHS official: "Do you have any sense of outrage?" Referring to Coast, he continued, "What steps are being taken right now to decertify these charlatans?"
The director of HHS's office that registers IRBs, Jerry Menikoff, said at the hearing that his bureau had only recently received the committee information about Coast, and would look into the matter. Sure.
Officials from HHS and the Food and Drug Administration assured lawmakers ‘that there were substantial protections in place to ensure that testing is done in a responsible and ethical manner.’ Anyone who believes that now deserves to believe it. Helluva job Brownie!
Until the invitation to the hearing Coast didn’t ever check on Device Med-Systems, who was the supposed developer of the gel. It does not exist, except as a P.O.Box in a shopping mall. Dr. Jonathan Q. Kruger, the Virginia doctor with a four-page curriculum vitae who was supposed to be leading the research doesn’t exist either.
Coast IRB, defended themselves by saying that the GAO violated federal and state criminal laws by falsely representing itself to be a medical device company and forging a medical license.
"We got hoodwinked," said Daniel Dueber, Coast IRB's chief executive officer.
"You didn't get hoodwinked," Stupak replied. "You took the bait, hook, line and sinker."
Coast did not do its due diligence. It investigated nothing about the company for five months and only began to do so when Coast’s medical board, which includes several physicians, as I said before, asked for the patient consent form to be revised. That was in October. A Coast official spoke on the phone to the supposed head of Device Med-Systems who agreed to make the requested changes. That was their investigation.
Today, April 1st, April Fool’s Day. there were still indications of the GAO investigation on the Web. I checked on Device Med-Systems.com and copied this from the ad.
Device Med-Systems is a professional science and technology organization that explores developmental areas of science and technology and manages clinical laboratories for customers. We provide a complete set of integrated and flexible clinical trial services to support biotechnology and medical device clients.
Device Med-Systems is a complete full-service provider. We are equipped to apply advanced scientific and technological expertise along the development process.
HHS Assurance Number FWA00013107
If you still believe the statements of government entities after this ask alternative health providers, the auto workers’ unions, the Indians, the polar bears or the whales. My opinion I think you already know.
