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T O P I C     R E V I E W
glassman  - posted
note that this is an op-ed, and not a News article:

Pharmaceutical Immunity Inexcusably Sought Over Objections of Career FDA Officials
October 30, 2008 - 09:24 PM

I start with the simple question: Does the Food and Drug Administration exist to protect the public health, or to shield pharmaceutical giants from responsibility for defective drugs or inadequate labeling?

After reviewing an astonishing report just submitted to Representative Henry Waxman's Committee on Oversight and Government Reform, I regrettably conclude that for the last 7 years the current adminstration has carried on an unprecedented and relentless assault upon this agency with the sole purpose of removing any meaningful protections for the consuming public in favor of insulating pharmaceutical interests from responsibility for the harms their products cause. The article makes it plain that even the career administrative heads and scientists were helpless to defend against the politically motivated "sea change" in philosophy that the administration forced upon them. The goal was to wipe out , once and for all, civil responsibility for defective drugs and devices under the auspices of "Federal Pre-emption," and not to follow the FDA's primary charter, "to protect the public health."

In the report entitled, "FDA Career Staff Objected to Agency Preemption Policies," it is first noted that the FDA's regulatory role in approving drugs and labeling requirements has historically been viewed as only one arm of the consumer protection process. Before the Bush administration, the FDA always viewed private litigation in State courts as a complimentary and "additional layer of protection against unsafe drugs." After all, the FDA must rely on the sponsors of the drugs for their testing and truthful reporting to evaluate the drug's effectiveness and dangers. Where the testing was inadequate, or the risks and hazards were concealed or understated, the results would be determined "in the field," i.e., when consumers were harmed or sickened by the drug.

In an effort to reverse this long-embedded viewpoint of the FDA, the Bush administration, through a series of modest regulatory changes, sought to make the FDA's approval of a drug or device sacrosanct and unassailable. To do this, the new regulations prohibited manufacturers from disclosing any new safety risks to the public without obtaining FDA approval first.


http://redding.injuryboard.com/fda-and-prescription-drugs/pharmaceutical-immunit y-inexcusably-sought-over-career-fda-officials-and-scientists-objections.aspx?go ogleid=250422

now? my question is: how does this affect "free market" principles?

it sure looks to me like socialism of risk and privatization of profit.

the Bush admin has done this across the board.


On November 3, 2008, the day before our country goes to the polls to determine the next administration, the case of Wyeth v. Levine will be argued before the U.S. Supreme Court. Potentially, this case will decide if the FDA has preempted the field and thereby nullified any ability on the part of individual consumers to recover for their injuries caused by defective drugs.
 
bdgee  - posted
I don't have a link to it, but there was a long article in our paper this morning about the Administration trying to sneak under the noise and hubbub of the election a whole series of measures to remove oversight and regulations (not just in drugs, but all sorts of things, particularly pollution and wildlife)across the board before the change to a new administration and make it impossible for states to oversee their own interest.
 
rhwdetroit  - posted
When it comes to deregulation and a smaller or more moderately sized government, I generally side with the republicans way of thinking. However, the pubs start to worry me when they take things to far. Anything that could have a potentially serious side effect on the nation bothers me. Drugs are not telecommunications. Pharmaceutical companies are already out of control and it seems to me that the pubs would like nothing more than to let them monitor themselves.
 
bdgee  - posted
The trouble with the republican's "smaller government" is that they refuse to define that term or allow it to be defined or allow that any specific size for it be determined. They have no interntion of following up on their blather. In other words, it is purely a pie in the sky scare tactic.

Just look at the size government is now after domination by republicans for years, then note that, with all that enormous size and cost, it isn't doing much of anything but using the Treasury to funnel funds from the middle class into the offshore accounts of huge corporations.
 
raybond  - posted
We have seen the affects of what the republicans mean by smaller government,and it sure stinks.

Smaller means rotten deadly food,filthy air,education in the crapper,overcrowding in correction,crime festering in expanding economic hell and health care becomeing more and more of a luxury instead of more available to Americans and unfit water to drink in most cities and farm areas.

Good-by republicans I would like to give each and everyone of you a boot in the butt as you leave in the custody of a federal marshall
 
glassman  - posted
don't hold back bond [Smile]
 
Propertymanager  - posted
quote:
Smaller means rotten deadly food,filthy air,education in the crapper,overcrowding in correction,crime festering in expanding economic hell and health care becomeing more and more of a luxury instead of more available to Americans and unfit water to drink in most cities and farm areas.
Have you been studying under Professor Gibberish? I don't know where you live, but here in Ohio the food is good; the air is very clean; education has not changed (except that the liberals have destroyed discipline in schools); prisons are not nearly crowded enough; healthcare is still available to all; and the water is clean and pure! Maybe you should move!
 
glassman  - posted
quote:
Originally posted by Propertymanager:
quote:
Smaller means rotten deadly food,filthy air,education in the crapper,overcrowding in correction,crime festering in expanding economic hell and health care becomeing more and more of a luxury instead of more available to Americans and unfit water to drink in most cities and farm areas.
Have you been studying under Professor Gibberish? I don't know where you live, but here in Ohio the food is good; the air is very clean; education has not changed (except that the liberals have destroyed discipline in schools); prisons are not nearly crowded enough; healthcare is still available to all; and the water is clean and pure! Maybe you should move!
once again you have serious problem with truth. we've already had this discussion here, so you should know better...

Lake Erie is in Ohio. it's better than it was when it and the Cayahoga river caught on fire. That incident is what triggered the Clean Water Act of 1972...

and i beleive Ohio has the most superfund sites of any state...

Cleanup Planned for Two Toxic Creeks Near Ohio Superfund Site




CHICAGO, Illinois, July 14, 2008 (ENS) - A month-long public comment period begins today on a proposed $3.8 million plan to clean a toxic insecticide from soil and sediment in two creeks near the Nease Chemical Superfund site in Columbiana County, Ohio.
The Superfund site covers 44 acres along state Route 14, 2.5 miles northwest of Salem on the Columbiana-Mahoning county line.

 
Propertymanager  - posted
quote:
... month-long public comment period begins today on a proposed $3.8 million plan to clean a toxic insecticide from soil and sediment in two creeks near the Nease Chemical Superfund site in Columbiana County, Ohio.
The Superfund site covers 44 acres along state Route 14, 2.5 miles northwest of Salem on the Columbiana-Mahoning county line.

So your argument is that 44 acres are poluted out of the 26,451,200 acres that make up Ohio? That's funny!
 
glassman  - posted
quote:
Originally posted by Propertymanager:
quote:
... month-long public comment period begins today on a proposed $3.8 million plan to clean a toxic insecticide from soil and sediment in two creeks near the Nease Chemical Superfund site in Columbiana County, Ohio.
The Superfund site covers 44 acres along state Route 14, 2.5 miles northwest of Salem on the Columbiana-Mahoning county line.

So your argument is that 44 acres are poluted out of the 26,451,200 acres that make up Ohio? That's funny!
LOL you're funny, take your corner  -

here's the EPA Superfund list, which are the worst of the worst:

* Allied Chemical & Ironton Coke (Ironton, OH)
* Big D Campground (Kingsville, OH)
* Buckeye Reclamation (St. Clairsville, OH)
* Chem-dyne (Hamilton, OH)
* Copley Square Plaza (Copley, OH)
* E.H. Schilling Landfill (Hamilton Township, OH)
* Feed Materials Production Center (USDOE) (Fernald, OH)
* Fields Brook (Ashtabula, OH)
* Fultz Landfill (Jackson Township, OH)
* Industrial Excess Landfill (Uniontown, OH)
* Lammers Barrel Factory (Beavercreek, OH)
* Miami County Incinerator (Troy, OH)
* Mound Plant (USDOE) (Miamisburg, OH)
* Nease Chemical (Salem, OH)
* New Lyme Landfill (New Lyme, OH)
* North Sanitary Landfill (Dayton, OH)
* Old Mill (Rock Creek, OH)
* Ormet Corp. (Hannibal, OH)
* Powell Road Landfill (Dayton, OH)
* Pristine, Inc. (Reading, OH)
* Reilly Tar & Chemical Corp. (Dover Plant) (Dover, OH)
* Sanitary Landfill Co. (Industrial Waste Disposal Co., Inc.) (Dayton, OH)
* Skinner Landfill (West Chester, OH)
* South Point Plant (South Point, OH)
* Summit National (Deerfield Township, OH)
* TRW, Inc. (Minerva Plant) (Minerva, OH)
* United Scrap Lead Co., Inc. (Troy, OH)
* Van Dale Junkyard (Marietta, OH)
* Wright-Patterson Air Force Base (Dayton, OH)
* Zanesville Well Field (Zanesville, OH)

SUPERFUND SITES THAT HAVE CONTAMINATED OR THREATENED DRINKING WATER SOURCES SERVING MORE THAN 100,000 PEOPLE
CHEM-DYNE BUTLER County OHIO
WRIGHT-PATTERSON AIR FORCE BASE GREENE County OHIO

SUPERFUND SITES THAT HAVE CONTAMINATED OR THREATENED DRINKING WATER SOURCES SERVING 10,001 TO 100,000 PEOPLE
PRISTINE, INC. HAMILTON County OHIO
ZANESVILLE WELL FIELD MUSKINGUM County OHIO


 
Propertymanager  - posted
quote:
SUPERFUND SITES THAT HAVE CONTAMINATED OR THREATENED DRINKING WATER SOURCES
It must have been "threatened" because I've lived in Ohio a long time and don't remember reading about anyone getting sick from the water! "Threatened" is another way to say that the water's fine - come on in!!!
 
glassman  - posted
quote:
Originally posted by Propertymanager:
quote:
SUPERFUND SITES THAT HAVE CONTAMINATED OR THREATENED DRINKING WATER SOURCES
It must have been "threatened" because I've lived in Ohio a long time and don't remember reading about anyone getting sick from the water! "Threatened" is another way to say that the water's fine - come on in!!!
you do it then..
 
glassman  - posted
i'm sure Ohio is a better place to live than MS, we cannot even eat wild fresh-water fish here that are over a year old because of the ag-pollution...

it's just not as clean as you want to think it is.

fact is? the average American does want a job and safe food and drugs and a clean environment too...

we are competing against a nation that until very recently could care less...

have you noticed that melamine has now shown up in baby formula, milk and eggs in China?

WE discovered it in dog food which had Chinese imports in it early last year...

we raised the issue with them, and they stopped loaning US so much money... in particular mortgage money.

Paulson wnet there in July last year to ask them to loan US more, and they refused.

that's when the "crisis" started... [Wink]

funny how "free trade" works huh?
 
bdgee  - posted
quote:
Originally posted by Propertymanager:
quote:
SUPERFUND SITES THAT HAVE CONTAMINATED OR THREATENED DRINKING WATER SOURCES
It must have been "threatened" because I've lived in Ohio a long time and don't remember reading about anyone getting sick from the water! "Threatened" is another way to say that the water's fine - come on in!!!
Heavy metals bring on Mad Hatter problems, you know, dementia. It may not show to the affected.
 
cottonjim  - posted
quote:
Originally posted by bdgee:
quote:
Originally posted by Propertymanager:
quote:
SUPERFUND SITES THAT HAVE CONTAMINATED OR THREATENED DRINKING WATER SOURCES
It must have been "threatened" because I've lived in Ohio a long time and don't remember reading about anyone getting sick from the water! "Threatened" is another way to say that the water's fine - come on in!!!
Heavy metals bring on Mad Hatter problems, you know, dementia. It may not show to the affected.
I havn't missed a day of work ywt cause of heavy metal's. http://www.youtube.com/watch?v=1qKGZ4Ysy5M
 
bdgee  - posted
quote:
Originally posted by cottonjim:
quote:
Originally posted by bdgee:
quote:
Originally posted by Propertymanager:
quote:
SUPERFUND SITES THAT HAVE CONTAMINATED OR THREATENED DRINKING WATER SOURCES
It must have been "threatened" because I've lived in Ohio a long time and don't remember reading about anyone getting sick from the water! "Threatened" is another way to say that the water's fine - come on in!!!
Heavy metals bring on Mad Hatter problems, you know, dementia. It may not show to the affected.
I havn't missed a day of work ywt cause of heavy metal's. http://www.youtube.com/watch?v=1qKGZ4Ysy5M
Yeah, well, being like a mad hatter is mental, not physical, so it probably wouldn't stop you working. And like I said, it doesn't necessarily show to the one that has it.

What is it they say? It's people that are crazy that are the ones that are sure they aren't? People like you and me, cj.
 
glassman  - posted
there's a dirty little secret about heavy metals poisoning, (not the Judas Preist type).

since i work with colored glass, and even the clear glass is loaded with toxic heavy metals, i've done alot of reading up on it.

back in the 70's? when they switched to unleaded gas? they said it was cuz catalytic converters couldn't run with it...
lead does interfere with the catalysts

* Oxidation catalysts: Palladium (Pd) and platinum (Pt) metals in very small amounts (to keep the catalytic converter price down) convert the hydrocarbons of unburned gasoline and carbon monoxide to carbon dioxide and water.
* Reduction catalysts: Palladium and rhodium (Rh) metals also in very small amounts convert the nitrogen oxide to nitrogen and oxygen. Nitrogen oxide is a big contributor to smog.



however, lead was ADDED to gasoline as cheap lubricant for the valves, and as an anti-pre-ignition agent..
pre-ignition is simply the gasoline lighting before the valves close...


what they don't like to talk about is that lead in gasoline was raising blood-lead levels across America.

since it was banned? blood-lead levels across the US have dropped 75%...

this has also associated with a lower crime rate...

there are dozens of studies linking non-toxic (moderate) exposure to lead and other heavy metals with juvenile delinquency..


GM scientists hit on in the early 1920s was to add a lead compound, tetraethyl lead, to gasoline. The resulting fuel was to be marketed by GM and Standard Oil under the name Ethyl. But in 1924, as tests were being conducted on the substance at a Standard Oil facility in New Jersey, several workers died from a form of sudden lead poisoning in which they became delirious and violent. Newspapers soon reported that other workers had died similar deaths at a DuPont Company plant, and that the company had tried to keep any word of the fatalities from getting out.


the surgeon general at the time was General Hugh Cumming, he proposed that "ethyl" be banned, but it failed to go thru...
 
bdgee  - posted
On the flip side of the lead poisoning from tetraethyl lead in gasoline question, though there has been that dramatic drop in the entire population's lead blood levels, with its associated drop in criminal juvenile delinquency, in recent years evidence is emerging of a significant problem effect of those same lowered lead blood levels in teen age boys, that brings on an uncontrollable urge to wear their pants so low they are barely held up.

Research into the phenomenon has, so far, not been able to find conclusive evidence that teen age girls have any increased interest in dropping their pants from low lead levels too, as, preliminary studies do not show a statistically significant increase in numbers of teen age pregnancies, but that consideration has only recently and not thoroughly been considered. Should it prove to be , after appropriate sufficient studies have been done, a problem in girls too, then, because it would show that the absence of leaded gasoline is acting as antibirth control device, Congress will be expected to form a comittee to study ways to combat the problem with appropriate input from outside interest groups, the Catholic Church in particular.
 



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