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Fictitious Medical Device Review Board Led by a Dead Dog (The Value of FDA Approved)
NaturalNews ^

Posted on 03/30/2009 9:42:30 AM PDT by Scythian

(NaturalNews) Just how trustworthy are medical review boards that review and approve medical devices? In a Government Accountability Office (GAO) sting, investigators were able to invent and register a fictitious review board with the Department of Health and Human Services (HHS), complete with a fictitious panel of doctors and a canine president named "Truper Dawg" (named after a real pet dog that had long since passed away).

Names of other board members on the fictitious organization approved by the Department of Health and Human Services included "April Phuls" and "Timothy Wittless." These names apparently did not raise any suspicions at the HHS. (Perhaps the U.S. government thought the review board was being run by a group of badly-named rappers?)

But that's not all: To check out the credibility of existing Independent Review Boards (IRBs), the GAO invented a fictitious medical product called Adhesiabloc -- an adhesive gel used as a kind of "stomach superglue" following surgery. A proposal to begin a clinical trial of this adhesive gel on humans was submitted to an FDA-recognized IRB company, and the company approved it! This, despite the fact that the clinical trial called for pouring one liter of this adhesive gel into the stomach of patients.

Misleading the misleaders The IRB that fell for the ruse was Coast IRB, LLC of Colorado Springs, which after being caught, charged that the GAO investigators violated federal law by misrepresenting themselves when they submitted false credentials to the review company.

But isn't this exactly what a medical review company is supposed to notice and prevent in the first place? This company seems to think they can trust everything they're told by any person or company applying for review, regardless of whether the medical products in question make any sense at all.

Coast IRB is one of 6,300 IRBs (Independent Review Boards) that certify pharmaceutical trials and medical device trials for consideration by the FDA.

The next time you considering using an "FDA-approved" medical device or pharmaceutical, remember this simple truth: In America, the Department of Health and Human Services will certify a fictitious review company headed by a dog!

If the GAO can pull this off after running the sting on just 3 companies, imagine how many of the 6,300 IRBs are certifying fraudulent, dangerous or outright deadly medical devices and pharmaceuticals right now!

What this fiasco really shows is that the medical device oversight system in America today is a complete joke. With the right paperwork, a medical device company could get review board approval for practically anything. And with the HHS accepting the credentials of fictitious review boards, the overseers of the review boards are so incompetent in their own jobs that the credibility of the whole system must be called into question.

Combine this with the corruption at the FDA, and you have to really wonder: Just how safe are the medical devices and pharmaceuticals being used by over a hundred million Americans right now? The answer, of course, is that many of them may have simply been rubber-stamped by dishonest or incompetent review board companies and HHS bureaucrats who have now been utterly exposed as either criminally dishonest or shockingly incompetent.


TOPICS: News/Current Events
KEYWORDS: fda; hhs
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1 posted on 03/30/2009 9:42:30 AM PDT by Scythian
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To: Scythian

“Coast IRB: Keeping it personal in an industry where nobody else does!”

http://www.coastirb.com/

Weird.


2 posted on 03/30/2009 9:47:30 AM PDT by Cicero (Marcus Tullius)
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To: Scythian

>The answer, of course, is that many of them may have simply been rubber-stamped by dishonest or incompetent review board companies and HHS bureaucrats who have now been utterly exposed as either criminally dishonest or shockingly incompetent.

I’d prefer calling them “criminally incompetent AND shockingly dishonest.”


3 posted on 03/30/2009 9:48:12 AM PDT by OneWingedShark (Q: Why am I here? A: To do Justly, to love mercy, and to walk humbly with my God.)
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To: Scythian

MOre proof that ANYTHING the government does is useless

Medcial costs are sky high BECAUSE of the FDA.

If they just insisted drug companies proved and document all the proof of their testing, instead of the incompetant government boobs repeating the testing then drugs would not cost as much

The threat of bankrupting the organization if they did not provide their own adequate testing would guarantee companies would make good drugs (the free market ALWAYS works)

And the cost and wait for new drugs would be less and FASTER

And we would not have stories like this one


4 posted on 03/30/2009 9:48:16 AM PDT by Mr. K (physically unable to proofreed (<---oops))
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To: Scythian
despite the fact that the clinical trial called for pouring one liter of this adhesive gel into the stomach

Oh come on now. Sounds perfectly fine if you're not too uptight, dude.

A department head from a major US pharma company told me after several beers on vacation in Germany that they did not test new drugs on humans. That was the end of my career as a medicine user and should be yours too.

5 posted on 03/30/2009 9:48:28 AM PDT by Veto! (Opinions freely dispensed as advice)
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To: long hard slogger; FormerACLUmember; Harrius Magnus; hocndoc; parousia; Hydroshock; skippermd; ...
Socialized Medicine aka Universal Health Care PING LIST

FReepmail me if you want to be added to or removed from this ping list.


6 posted on 03/30/2009 9:49:09 AM PDT by socialismisinsidious ( The socialist income tax system turns US citizens into beggars or quitters!)
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To: Scythian

And here’s Coast IRB’s Press Release on this matter:

http://www.coastirb.com/press-releases


7 posted on 03/30/2009 9:49:34 AM PDT by Cicero (Marcus Tullius)
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To: Scythian
"If the GAO can pull this off after running the sting on just 3 companies, imagine how many of the 6,300 IRBs are certifying fraudulent, dangerous or outright deadly medical devices and pharmaceuticals right now!"

Just goes to show you what big "nanny state- keep me safe cause we are all too stupid to take care of ourselves- government' is really all about, -the money, and little private government empires for Democrats.

8 posted on 03/30/2009 9:51:24 AM PDT by Nathan Zachary
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To: Scythian

Well, when Obama sees this report, he will add another layer of bureaucracy on top.

A new White House post, perhaps, “Office of the Drug Testing Czar.”


9 posted on 03/30/2009 9:51:55 AM PDT by Cicero (Marcus Tullius)
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To: Scythian

I listen to a homeopathic doctor, Dr. Winer, on the radio. He talks about the side effects of common FDA-approved medications. It is quite scary. He is currently railing against Lipitor, which can cause severe heart problems.


10 posted on 03/30/2009 9:54:13 AM PDT by goodwithagun (My gun has killed less people than Ted Kennedy's car.)
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To: Mr. K
Medcial costs are sky high BECAUSE of the FDA.

Don't ever leave the bambulance chasers out of the mix when discussing high medical costs...


11 posted on 03/30/2009 9:54:23 AM PDT by ErnBatavia (Here's hoping the Kennedy family trust is in deep....with Madoff)
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To: Veto!
What a steaming pile of crap.

We do test drugs on humans before they are brought to market.

I work in pharma, and I hear the terms “first in human” and “phase 3 human trials” all the time.

Are you saying this US pharm company department head was revealing a secret conspiracy, that we CLAIM to test in humans but do not?

12 posted on 03/30/2009 9:55:47 AM PDT by allmendream ("Wealth is EARNED not distributed, so how could it be redistributed?")
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To: Veto!
"A department head from a major US pharma company told me after several beers on vacation in Germany that they did not test new drugs on humans. That was the end of my career as a medicine user and should be yours too."

Oh come now, of course they test new drugs on humans. You just have to use a little common sense and wait for the results in a year or so before trying the stuff out for yourself. If people are getting sick, suffering bad side effects, heart attacks etc. don't take it.

13 posted on 03/30/2009 9:56:35 AM PDT by Nathan Zachary
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To: Scythian
From Coast's website:

"You can rest assured that your study will be reviewed quickly and with no attention to detail spared."

14 posted on 03/30/2009 10:01:21 AM PDT by erikm88
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To: SeaDragon; TheGrimReaper

(sigh)

ping


15 posted on 03/30/2009 10:01:37 AM PDT by RikaStrom (Bitter? Who me? Nah, I'm just clinging to my guns!)
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To: ErnBatavia

Exactly. That is by far, the biggest reason why drugs cost so much in the USA. And because Democrats, who are largely lawyers who made so much money chasing those ambulances, torte reform bills will never see the light of day.


16 posted on 03/30/2009 10:01:56 AM PDT by Nathan Zachary
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To: goodwithagun
"I listen to a homeopathic doctor, Dr. Winer, on the radio. He talks about the side effects of common FDA-approved medications. It is quite scary. He is currently railing against Lipitor, which can cause severe heart problems."

Remember, those homeopathic "doctors"(they aren't real doctors) are trying to sell you something.

How silly to claim it CAUSES heart problems when the people who take it, take it BECAUSE they have heart problems, and are taking lipitor to reduce their colestrol levels.

Lipitor MAY cause side effects, but heart attacks aren't one of them.

These infomercial "doctors" are just trying to sell you their own magical "natural medicine" Hyloronic acid, or some miracle compound that 150 year old Japanese in some remote village nobody has ever heard of, look like they are 20 years old.

They are nothing more than snake oil salesmen.

17 posted on 03/30/2009 10:10:53 AM PDT by Nathan Zachary
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To: goodwithagun
I listen to a homeopathic doctor, Dr. Winer, on the radio. He talks about the side effects of common FDA-approved medications. It is quite scary. He is currently railing against Lipitor, which can cause severe heart problems.

I'm sure you're familiar with the efficacy and side effects of common homeopath-approved remedies? Just in case you're not, read this.

18 posted on 03/30/2009 10:16:43 AM PDT by Caesar Soze
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To: goodwithagun

And remember, most of that so called “natural”, homeopathic herbal medicine, or “Natural source” formulations, are made bulk in China, and could contain who knows what left over powders some Chinaman looking for a quick buck bought at a auction sale for some chemical company that went out of business.


19 posted on 03/30/2009 10:19:49 AM PDT by Nathan Zachary
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To: Caesar Soze

I am fully aware of all natural remedies. After all, people die from bee stings and they are all natural. My point is that some FDA-approved drugs are not the answer. Especially when someone is obese and on cholesterol/blood pressure/diabetes/asthma meds.


20 posted on 03/30/2009 10:20:46 AM PDT by goodwithagun (My gun has killed less people than Ted Kennedy's car.)
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To: Caesar Soze
those homopath remedies are checked by the FDA either, although many of them claim to be tested by some independant lab somewhere.

it's just another billion dollar scam industry, no different than cough medicine, diet pills.

American's are the biggest suckers in the world when it comes to pills and medications, always hoping for that magic pill that will make them healthy and trim while sitting on the couch eating bonbons, cheetos, drinking beer and flicking the remote.

21 posted on 03/30/2009 10:25:02 AM PDT by Nathan Zachary
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To: Nathan Zachary

aren’t checked


22 posted on 03/30/2009 10:27:35 AM PDT by Nathan Zachary
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To: Nathan Zachary

Actually the doctor has been in business, successfully, for many years. He came as a recommendation from a friend. I have also recommended him to others and have not had one dissatisfied person yet. He is not anti-western medicine. Also, Lipitor’s website lists the problems that can occur. The site info says that a “small number” of people may have side effects. Do a quick search and find out how many a “small number” is. He is also not a fan of acid reflux meds. They cause some serious problems. He performed a non-invasive, non-painful procedure on my father. He simple manipulated dad’s stomach down off of his esophagus and dad has been fine ever since. He was on the purple pill for years. Dad swears by Dr. Winer and has also suggested him to friends.


23 posted on 03/30/2009 10:27:52 AM PDT by goodwithagun (My gun has killed less people than Ted Kennedy's car.)
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To: Nathan Zachary

“Hyloronic acid”. Is that like Dyhydrogen Monoxide? That stuff is truly dangerous. Just a little in your lungs can kill you! I mean people die from that stuff every year!

All kidding aside, it is a serious issue that this was able to be done. It is also a serious issue that lawyers have spiraled malpractice insurance, drug costs, and research costs into, and probably out of, orbit.

But other lawyers, Congressional Dems, have the “solution” to the problem they and big government ignoramuses created: Yet More Government!

I think I need a liter of that “stomach glue” to make this all make sense.


24 posted on 03/30/2009 10:28:27 AM PDT by M1Tanker (Proven Daily: Modern "progressive" liberalism is just National Socialism without the "twisted cross")
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To: Nathan Zachary

His supplements are all created in the US. Most of his supplements are vitamins and minerals, not herbs. For example, I developed restless leg syndrome during my pregnancy. I could not safely take any meds for this. I did some research and found the cause of rls is iron deficiency. I went to Dr. Winer and he told me the same. He did a blood test, recommended an iron supplement and I was finally able to sleep. The meds were not only dangerous to the baby, but they treat the symptoms and not the cause. He also diagnosed a fungal disease that my the med doctors kept giving me antibiotics for. They said I had a sinus infection. Dr. Winer told me to flush my nasal cavity with a solution of one part hydrogen peroxide and three parts water. He told me all of this over the phone at no charge to me. Two days later, I could breath again.


25 posted on 03/30/2009 10:34:17 AM PDT by goodwithagun (My gun has killed less people than Ted Kennedy's car.)
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To: goodwithagun
"Actually the doctor has been in business, successfully, for many years. He came as a recommendation from a friend. I have also recommended him to others and have not had one dissatisfied person yet."

Just because "a friend", sucked into the mans sales pitch, recommended him doesn't qualify him as a "doctor". He is NOT a doctor.

As for him "manipulating" your dads stomach off his esophagus, (an impossibility) Should have flashed "QUACK" signs to you right off the bat. If my dads stomach was in his neck I'd have taken him to the hospital for immediate surgery.

26 posted on 03/30/2009 10:49:32 AM PDT by Nathan Zachary
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To: goodwithagun
His supplements are all created in the US.

he's a liar.

27 posted on 03/30/2009 10:51:06 AM PDT by Nathan Zachary
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To: goodwithagun
His supplements are all created in the US.

he's a liar.

The pills he's selling you make have been relabeled and repackaged in the USA, but the reality is they are made bulk in China mostly.

28 posted on 03/30/2009 10:52:27 AM PDT by Nathan Zachary
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To: Nathan Zachary

Who peed in your Cheerios this morning? Am I demanding that you see this doctor for your ailments? You may do as you choose. For some of my medical problems, especially during my pregnancy, these things worked. Dad has had his esophagus checked for further damage and there is none. He is fine now, the acid reflux is gone (after being told he would be on meds the rest of his life), and he does not have to worry about the nasty side effects. You know that antacid meds are linked, scholarly, to alzhiemers don’t you? By the way, the esophagus goes all the way down to the stomach. His stomach, as with all hiatal hernias, was pushed up onto the end. It was not in his neck, a$$bag. Please refer to an anatomy chart before responding again.


29 posted on 03/30/2009 10:58:20 AM PDT by goodwithagun (My gun has killed less people than Ted Kennedy's car.)
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To: Nathan Zachary

If you could please reference your source, I would appreciate it. Otherwise, piss off.


30 posted on 03/30/2009 10:59:32 AM PDT by goodwithagun (My gun has killed less people than Ted Kennedy's car.)
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To: goodwithagun
And if you really want to stop acid reflux, just take a teaspoon of vinegar when you have heart burn. It will stop your galbladder from producing bile. The reason those antacids don't cure heartburn is because they reduce the acids in your stomach temporarily, which then causes incomplete digestion, triggering your stomach to call for more bile. Vinegar is an acid, so it tricks your digestive sytem into thinking it has enough bile, so it stops calling for more.

Eventually, your digestive system will return to normal, and you won't need to take vinegar after a week or so.

Taking antacids just trains your system to produce too much bile all the time.

So there, I just saved you a small fortune worth of expensive homopathic medicines made from special herbs found only on the south side of a remote mountain in tibet that grows only one night every three years when theres a blue moon.

31 posted on 03/30/2009 11:03:17 AM PDT by Nathan Zachary
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To: goodwithagun
My source? just look up any medical chart and see where your stomach is, and feel your own neck to find where your esophagus is.

Your stomach can't "be on your esophagus, the esophagus leads to your stomach, and has a pancreas gland and ducts on it near where it attaches to your stomach.

No need to get all pissy just because I'm LMAO at your stupid Homopathic "doctor"

32 posted on 03/30/2009 11:07:45 AM PDT by Nathan Zachary
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To: Nathan Zachary

I think I mentioned that his supplements are vitamin and mineral based, not plant based. Oh, and his biggest “prescription” is teaching people how to properly eat. And he is not a small fortune. His office visits are covered by my insurance. Luckily, I have only had to go a few times. I was going to the doctors over and over for my rls, only to be told in the end that they could do nothing due to my pregnancy. Now that is a waste of money.


33 posted on 03/30/2009 11:07:50 AM PDT by goodwithagun (My gun has killed less people than Ted Kennedy's car.)
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To: goodwithagun
I also have a friend who runs a health foods and natural "medicines" import business. He supplies the bulk stuff to health food/ homopathic remedies retailers. It's just a big scam market is all it is, mostly just harmless snake oil, but some stuff can kill you if you take it with other "harmless on it's own" stuff, or with real meds.

With homopathic medication pushers, they do not watch for, nor have any training to know what could be dangerous interactions between seemingly harmless "natural" compounds, or between them and the "natural" compounds in traditional real Doctor prescribed pharmaceuticals.

34 posted on 03/30/2009 11:17:24 AM PDT by Nathan Zachary
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To: allmendream

We report, you decide. I don’t take any new drugs. Ten-year-old drugs work fine.


35 posted on 03/30/2009 11:20:09 AM PDT by Veto! (Opinions freely dispensed as advice)
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To: goodwithagun

You can even do one step better, and eliminate both real doctors, and those pretend homopathetic “doctors” from your life and just find a good nutritionist/ dietitian.

You can get absolutely everything your body needs just by eating the right foods, and staying moderatly active.


36 posted on 03/30/2009 11:22:16 AM PDT by Nathan Zachary
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To: Scythian

I dated a girl named April Phuls one time. ;)


37 posted on 03/30/2009 11:24:05 AM PDT by Perdogg (Go Tarheels)
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To: Nathan Zachary

www.painreleaseclinic.com


38 posted on 03/30/2009 11:24:10 AM PDT by goodwithagun (My gun has killed less people than Ted Kennedy's car.)
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To: goodwithagun
"I think I mentioned that his supplements are vitamin and mineral based, not plant based."

Where do you think vitamins and minerals come from?

39 posted on 03/30/2009 11:24:13 AM PDT by Nathan Zachary
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To: Nathan Zachary

I wait many years.

To illustrate: My friend with major blood pressure problem was put on this and that up-to-the-minute miracle drug by a prominent physician. Still a problem. Then her HAIRDRESSER suggested an old blood pressure med that DID NOT cause hair to fall out. She switched to the very old med. Blood pressure fine for the first time in decades, hair growing in.


40 posted on 03/30/2009 11:24:55 AM PDT by Veto! (Opinions freely dispensed as advice)
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To: Nathan Zachary

You know what I mean. They are vitamins like B12 and minerals like calcium. Not exotic nocturnal African nightshade.


41 posted on 03/30/2009 11:25:25 AM PDT by goodwithagun (My gun has killed less people than Ted Kennedy's car.)
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To: goodwithagun
"And he is not a small fortune. His office visits are covered by my insurance"

Oh, so it costs us all a small fortune then... Which insurance company is that? I'll make sure I avoid it.

42 posted on 03/30/2009 11:25:40 AM PDT by Nathan Zachary
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To: Veto!
Not for the fraudulent and absolutely false reasons you claim, as human testing IS done; but not a bad idea overall to limit your drug intake to those drugs that have been in “human trials” wide-scale for over ten years.
43 posted on 03/30/2009 11:26:04 AM PDT by allmendream ("Wealth is EARNED not distributed, so how could it be redistributed?")
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To: Veto!

That happened to me as well. I was put on that latest pain miracle pill, and had that heart attack.

That was before the lawsuits started flying around, and the docs couldn’t figure out why I had the heart attack. Had to go through that angiogram procedure, all for nothing.


44 posted on 03/30/2009 11:35:01 AM PDT by Nathan Zachary
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To: allmendream

I’m not “claiming” anything. I’m reporting what a drug company dept head told me in private.

Basically, I take NO drugs. And because I don’t, I probably never will need them.


45 posted on 03/30/2009 12:30:40 PM PDT by Veto! (Opinions freely dispensed as advice)
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To: Nathan Zachary

Sorry to hear about your drug problems, glad you made it through. Scary.


46 posted on 03/30/2009 12:32:27 PM PDT by Veto! (Opinions freely dispensed as advice)
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To: Veto!
You think people who never take drugs never get cancer?

Take your arms from around the tree, spit out that granola, put down the bong.

47 posted on 03/30/2009 12:55:57 PM PDT by allmendream ("Wealth is EARNED not distributed, so how could it be redistributed?")
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To: Scythian; socialismisinsidious; bamahead; Lurking Libertarian; FormerACLUmember; SunkenCiv; ...
This is a story obviously written by some lefty to create fear in the public and thereby drum up support for even more government involvement in the drug and medical devices approval procedure.

It has been argued by many for decades that drawn out bureaucratic FDA approval procedures already in force have caused needless deaths and disabilities in the general population, to say nothing of added costs passed on to the consumer.

48 posted on 03/30/2009 2:16:17 PM PDT by justiceseeker93
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To: Nathan Zachary

Health Assurance and it doesn’t cost you shit. It is part of my benefit package from my employer.


49 posted on 03/30/2009 2:21:09 PM PDT by goodwithagun (My gun has killed less people than Ted Kennedy's car.)
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To: Scythian

thnx for the post

http://www.neoperspectives.com/fda_tyranny.htm


50 posted on 03/30/2009 2:38:50 PM PDT by traviskicks (http://www.neoperspectives.com/Ron_Paul_2008.htm)
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