FDA Approves Nonexistent Product from Nonexistent Company for Human Testing

FDA Approves Nonexistent Product from Nonexistent Company for Human Testing

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.

please follow the link and read the whole article

one of those who had been caught in the sting actually claimed they were setup and the whole operation was illegal;
that congressional investigators had “perpetrated an extensive fraud against my company.”

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.

I don't know about you, but I think that anything with the label of FDA approval isn't to be trusted as far as it can be thrown away, what do you think?

in related news : The USDA’s Organic Deception

reply to post by DerepentLEstranger


Nice reporting! Something really needs to be done about this *munch munch* but I'm so busy........ Oh hey a shiny set of keys... What was going on again?

reply to post by DerepentLEstranger



Oh jeez. Especially this bit:

“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.

Good story. Unfortunately.

Good thread! The importance of Accountability again surfaces. But it seems that all of those who decide who is to be held accountable, are elected officials...often elected simply by the depth of their pockets or in rigged elections. So, on the surface the perception is, that we the people actually chose them.

It is not surprising that holes in the system are so easily shown. The real problem is how to fix it. Being two years on since the last test and things have only gotten worst is a very concerning sign. While bribery is legitimised in government with lobbying and other techniques, it is just unable to respond to implement a fair and just system. The corporations have the money and the government is becoming a tool for them rather than a way of balancing the competing social interests.

This is why "FDA approval" doesn't give me that warm fuzzy feeling it should. Since I got laid off last year and have been home during the late morning-early afternoon its been hard not to notice the non-stop barrage of commercials from law firms asking me to call them if I took this or that FDA approved drug because of the side-effects that accompany them. The way to fix it is to take the money out of it, health professionals should be motivated by the desire to help people, not to get filthy rich. Undoubtedly, that would mean less drugs, procedures, doctors, etc...but I still think in the end we'd all be better off if doctors were knocked off of their pedestal, were compensated less, and pharmaceutical companies could not buy product placement and diagnosis from them.

Wow, a real post with real documentation and basis in fact. Great post OP!! Thanks

How many times must those who are sitiing in high places be shown to be utter fools, whose morals are far less than upright?
Ths is another tooth grinding example of the kind and quality of the people who are in control of our lives and health.
Subnormal IQ? No hindrance to sitting in positions of grave ressponsibility, provided you are a member of the in group, or can bribe your way into it.

There has to be an end to this kind of utter stupidity somewhere.....i hope it is not our undoing first.

reply to post by DerepentLEstranger


Anything that is run by the government is a big waste of time. They only care about 1 thing and that is how much money can they get from us before we have had enough. Do you think they really care about our well being? Do you even hear anything about the oil spill anymore? All the dead birds and dead fish must be caused by fireworks or some lightning storm right? Just in our drinking water we drink many different drugs each day but nothing is done about that. It is a sad time in our history, the government is all about saving itself rather than the people. They see what they are doing and don't care, when the time comes the will head off to there underground facilities while we sit here and suffer.

reply to post by DerepentLEstranger


Strange bed fellows indeed.
This could also be called a Ponzi Scheme...in the financial world.

This one was caught, how many are not?
Great Post Op,

Thanks for the links and the charts are great.
I have one of them in my kitchen but was outdated, until now.

S&F!

thank you all for your replies

I'm a bit rushed today so as an answer to the posts by:

burntheships
lightsource
budaruskie
stirling

indeed, you simply cannot place your trust in any of these agencies to the detriment of your health/life.
and there doesn't seem to be any point at trying to fix any of this "within the system" [which is how TPTB want you to try]. we are just simply going to have to do our best on our own and stop giving our sanction/support.

here is another example about how these agencies work in this case the AMA which started out as legitimate private organization and was literally taken over and perverted into a money making scheme by this disgusting little fellow : Morris Fishbein - AMA Enemy Of American Health

kwakakev: yeah, our so called representatives are all bought and owned by special interests, and have long shown their true motivations and yet people continue sanctioning/supporting this system.

soficrow: what with all the $$$$$$ signs clouding their vision, it's no surprise at all.

totalmetal: uhh, thanks

WOW.. excellent thread OP!!!


IMO the FDA is a criminal govt run org.. just as everyone else with any ability to think/read here does. The problem is that we rarely get to see the screw-ups proving this as glaringly as you just pointed out! Thank you.

The FDA scares me. Ive had a lot of experience ( more now than when I was working in the med field) to experience it first hand. My middle daughter is a transplant recipient and on many drugs to keep her alive. I study the drugs the team speaks of switching her to and etc and WOW.. what they okay is incredible. If it doesnt kill you they think its okay or if it only kills or maims a certain percentage of human beings its okay to mass prescribe?! Scary indeed.

IMO it seems like they are getting nmore careless these days or we simply have more access to the information. Either way, we need to pay much closer attention to what we consume because they are carelessly approving things that are so very dangerous to us within our food, our meds, and etc.

Before I started coming here several years ago I really thought the FDA was looking out for us.. at this time Im right there with you conspiracy guys concerning the FDA..

before signing off thought I'd share this with you all

[atsimg]http://files.abovetopsecret.com/images/member/5f65480558aa.jpg[/atsimg]

Really, what this whole situation comes down to is funding. There source of the money, (you and I) has no way of keeping people accountable. Remember, the government simply acts as a clearing house for our money. It's not theirs so they have no compelling reason to be prudent in spending it. Tax dollars are like a free-flowing well of never-ending cash.

The only way to rein in this fraud is through oversight with penalties as stringent as what the IRS uses to collect the money in the first place. Hold the FDA, HHS and all the rest of them accountable for not doing due diligence. As it is now, it's like the fox guarding the hen house. Until some people go to prison for fraud, nothing will change. It should be taken all the way to the top; Kathleen Sebelius. She should be fined and/or fired for not properly overseeing her own department.

These government employees will be the first ones to pat themselves on the back when they accidentally do something right but don't think they should be held accountable when they screw up. They should be fired for incompetence, at the very least and imprisoned and the most.

Why are tax dollars being wasted on this stuff ..
If there is a new potential drug or treatment and a doctor and patient willing to try it why should it be the governments business. Simple contracts between willing people would cover everything, and I bet they pay attention when its personal.

Great information. Thanks for sharing. I will link this thread to mine as I think this provides an (indirect) link to my question on why a perfectly safe drug, prescribed for a number of ailments for decades in Europe, didn't get approved in the US until 1994 by the FDA. I want to know why and this confirms that the reasons are more than likely nefarious.

Just want to clarify for some people who may be confused that the ficticious company Device Med Systems garnered approval to begin clinical trial procedures from the Coast IRB. This is extremely different from the FDA approving a product for an indication to be used by the public.

I'm not denying that this incident is disturbing, and definitely raises questions about the amount of oversight that is being done. It definitely sheds more light on the use of for-profit IRB's and the potentially inherent conflict of interest.

Although it is quite scary to think about the consequences if this hadn't been a sting operation and the product had been used on clinical volunteers without proper review prior to initiating trials - I think it's important to realize that such a product would likely never make it to the market under an FDA approval due to the extensive peer review process the multiple staged trial results would have been subjected to.

Also, just wanted to provide a link for another source I came across that includes original articles from both the New York Times and the Wall Street Journal from back when this story first came out.
AHRP.org

reply to post by Lebowski achiever


hey dude, how are things going for you?

sure link away.

reply to post by LuckyOscar

thank you for your post.
however, to the degree that this seems business as usual [they sit in their air conditioned offices and farm out all the real work], don't be disturbed.
be very disturbed.