Final Solution aka Final Rule

[Guest guest]

=The lawlessness of the FDA, Big Pharma immunity,

and crimes against humanity =

 

by Mike Adams

(opinion)

 

June 30, 2006 is a day that will be long remembered as

a dark milestone in the history of FDA and its

campaign against health consumers.

 

On June 30, an FDA " Final Rule " goes into effect,

establishing a regulatory power grab of such scale and

scope that it attempts to bypass all laws, the will of

Congress and fundamental protections for consumers.

 

This " Final Rule, " which may as well be called a

" Final Solution " for drug consumers, claims that

consumers can no longer sue drug companies for the

harm caused by any FDA-approved drug, even if the

drug's manufacturer intentionally misled the FDA by

hiding or fabricating clinical trial data.

 

In one blatantly illegal act, the FDA is attempting to

pull off the greatest Big Pharma coup of all: The

outright elimination of any responsibility whatsoever

for the suffering and death caused by deadly

pharmaceuticals.

 

In the preamble of the FDA's new " Final Rule " to take

effect on June 30, the agency asserts that FDA

approval of prescription drugs -- and their implied

safety -- may no longer be second-guessed by consumers

or organizations of any kind. The FDA's stamp of

approval, the agency claims, is an absolute

declaration of safety of all such drugs, for any use

whatsoever, including off-label use (the use of drugs

on health conditions that were never tested in

clinical trials).

 

But such a position has no basis in law. During a June

6, 2006 hearing, a New Jersey state court judge Carol

E. Higbee characterized the FDA's preamble as, " a

political statement by the FDA " and explained that the

ploy has, " ...nothing to do with science. ...It is

contrary to the U.S. Supreme Court's decisions. It is

contrary to all the law on preemption. ... In addition

to being contrary to the law of the land, it is also

contrary to the Constitution of the United States. "

 

The FDA is dangerous to America

That this outrageous assertion by the FDA would take

place at a time when so many Americans are routinely

killed by the harmful side effects of prescription

drugs only contributes to the arrogance and absurdity

of this rogue agency that has now become the No. 1

threat to the health and safety of the American

people. Even a terrorist nuclear attack on a major

U.S. city would not equal the number of Americans who

have already been killed by the negligent actions of

the FDA.

 

FDA-approved prescription drugs injure 2.2 million and

kill approximately 100,000 Americans each year,

according to peer-reviewed published studies, and more

realistic estimates put the number of deaths at over

200,000 people annually in the United States alone

(see Death By Medicine for detailed statistics).

Vioxx, according to senior FDA drug safety researcher

Dr. David Graham, appears responsible for the deaths

of over 60,000 Americans, and further deaths due to

beta blockers, antidepressant drugs, statins and other

medications continue to mount by the hour.

 

The resulting FDA body count of American casualties

makes the casualties of war look small in comparison.

The Vietnam War claimed the lives of approximately

50,000 Americans (plus many more Vietnamese), and a

memorial in Washington D.C. honors those who died. But

FDA-approved prescription drugs have killed well over

a million Americans, yet no memorial will be built, no

honors bestowed, and now the FDA would deny the

families of those victims their legal right to fight

for any sort of compensation.

 

It's not like these consumers were killed by enemy

gunfire in a foreign land; they were killed by

American companies, on American soil, with the full

permission and approval of an American regulatory

agency! The enemy from within is, indeed, far more

dangerous than any foreign threat to the lives of

American citizens. Not since World War II have so many

Americans died from a single, common, preventable

cause, and it almost seems that the FDA has declared

war on the American people and is using chemical

weapons to win that war.

 

The scourge of dangerous prescription drugs, combined

with willful collusion at the FDA, has now created a

chemical holocaust on U.S. soil that will continue to

claim the lives of mothers, fathers, daughters and

sons until the American people demand that justice be

served and that the FDA / pharmaceutical industrial

complex be dismantled and condemned through some

modern-day equivalent of the Nuremberg Trials. How

many millions more have to die from this chemical

holocaust before this reign of medical terror is

brought to an end?

 

The ramifications of the FDA's Final Rule

The FDA's new " Final Rule " would allow drug companies

to operate with impunity, shouldering absolutely no

responsibility for the harmful (even fatal) side

effects of their prescription drugs, many of which we

are now learning were only approved under highly

suspicious circumstances that smack of fraud,

corruption and outright criminal intent. Consumers

harmed or killed by toxic prescription drugs -- even

drugs that their manufacturers knew were extremely

dangerous -- would have no recourse whatsoever.

 

If such a rule were to go unchallenged, the degree of

profiteering by Big Pharma would be unprecedented.

Free to charge monopoly prices thanks to the

FDA-enforced domestic drug racket that outlaws

international competition, and unburdened by the

financial risk of lawsuits from consumers harmed by

their drugs, Big Pharma would be emboldened to unleash

a dystopian era of unprecedented disease mongering,

bribery of doctors, false advertising and the mass

drugging of children, adults and seniors alike... with

absolutely nothing to hold them in check.

 

This result may, in fact, have been the intention all

along. This " Final Rule " appears to be little more

than a thinly-veiled attempt to establish wide-ranging

authority where none exists by burying it in the

language of a drug labeling rule. A more detailed

legal criticism is offered by Karen Barth Menzies, an

attorney at Baum Hedlund in Los Angeles:

 

On Wednesday, Jan.18, 2006, the Food and Drug

Administration issued new regulations regarding the

labeling of prescription drugs, including regulations

aimed at providing doctors and patients with clearer

information about the risks associated with

prescription drugs. However, in the preamble to these

new regulations, the FDA inserted conclusory and

legally unsupported statements that tort lawsuits

alleging a failure to warn of known or reasonably

knowable safety risks are preempted by federal law.

This attempted power-grab by the FDA wholly ignores

the prerogative of Congress, contradicts both

statutory and case law precedent, disregards the

parallel but distinct roles played by FDA and tort

liability law, fails to provide an avenue through

which consumers may be compensated for drug-induced

injury, neglects any federal replacement of applicable

state policing and enforcement procedures, and shirks

constitutionally established principles of federalism

which protect the jurisdiction granted to states in

matters involving public safety and health. By

inserting preemption language into the Final Rule

without an official consultation with state and local

government groups concerning the preemption language,

the FDA also violated Executive Order (E.O.)13132.

(When an Executive department or agency proposes to

act through adjudication or rule-making to preempt

State law, the department or agency shall provide all

affected States notice and an opportunity for

appropriate participation in the proceedings. Exec.

Order No. 13132, [[4(e), 64 Fed.Reg. 43255, 43257

(1999). According to the National Conference of State

Legislatures (NCSL), the preemption language inserted

into the preamble of the Final Rule is a thinly veiled

attempt on the part of FDA to confer upon itself

authority it does not have by statute and does not

have by way of judicial ruling. The NCSL called FDA s

action an abuse of agency process and a complete

disregard for our dual system of government.

 

The fallout of the FDA's " Final Solution "

The ramifications of this " Final Rule " action by the

FDA cannot be overstated. If this rule is allowed to

stand, it represents the end of health justice, the

end of the power of Congress, and the surrender of

absolute power to an agency of such arrogance and evil

that it has conducted armed raids on vitamin clinics,

organized the raid of a church, and even ordered the

destruction of recipe books it didn't want to see

published. (Supporting documents are available for all

of these statements).

 

The FDA, through its willful negligence, is indirectly

responsible for the deaths of more Americans than all

terrorists, murderers and drunk drivers combined. As

the deaths continue to mount, and drug companies

become even more aggressive with outlandish disease

mongering and advertising efforts, the FDA rears up to

unleash a new wave of corporate terrorism upon the

American people by emboldening drug companies to care

even less about the safety of their synthetic chemical

products, most of which cause harm by their very

nature of being foreign to the human body.

 

As Menzies explains:

 

Pharmaceutical industry lobbying efforts and zealot

tort reformers have sired a new wave of brazen

attempts to shield drug manufacturers from tort

liability. The preemption language in the preamble to

the Final Rule is but the latest attempt. Preemption

has become the argument du jour and politically

appointed regulatory officials the mouthpieces. The

crafty messages sound of consumer protection, but are

just the opposite. Limiting the liability of drug

companies will not improve public safety. The FDA's

purported position on preemption assumes that the FDA

is infallible and that negligent misconduct by

pharmaceutical companies should be the sole purview of

FDA. Recent regulatory failures demonstrate that FDA

is neither infallible nor does it have the capability

of policing drug manufacturers negligent misconduct.

 

Want to see the real FDA at work? Read the story of

Rezulin, and you'll be shocked to learn the truth

about the real agenda that drives this rogue agency.

 

The end is near for the Big Pharma / FDA racket

Why would the FDA engage in such an obviously unlawful

power grab? Because Big Pharma co-conspirators have

realized that lawsuits threaten to bankrupt the drug

companies. The products of these companies are so

universally harmful, and their ability to hide this

truth is slipping away so rapidly, that the financial

burden of settling lawsuits (or defending them in

court) threatens to crush the entire pharmaceutical

empire.

 

Merck alone is defending itself against literally

thousands of lawsuits from just one drug: Vioxx. As

the truth emerges about the dangerous side effects

from the long-term use of other widely-prescribed

drugs, class action lawsuits will reach a momentum

that will make the Big Tobacco settlements seem like a

friendly game of Friday-night poker.

 

Truth be told, there is not enough money in the world

to pay for all the pain, suffering and death that has

already been caused by prescription drugs, and if drug

companies are held responsible for even a small

fraction of the patients their products have harmed

and killed, they will rapidly fall from the most

wealthy corporations in the world to the most

bankrupt, both financially and morally.

 

And so the FDA is jumping in with one last, desperate

attempt to cast a spell of immunity over all drug

companies in order to preempt the coming flood of

class action lawsuits. But even this effort will fail,

as the truth about the dangers of prescription drugs

can no longer be censored. Through a tidal wave of new

books, documentaries and health websites, consumers

are learning the shocking truth about Big Pharma and

the FDA, and the beginning of the end of the age of

chemical medicine is already under way.

 

Reading suggestions: The Truth About the Drug

Companies by Marcia Angell, M.D., Psyched Out by Kelly

Patricia O'Meara, or Death by Prescription by Ray

Strand.

 

You see, the arrogance and greed of drug companies

will ultimately be their downfall. They have pushed

too hard, too far, and they have landed themselves in

a realm of such obvious scientific fraud and criminal

negligence that the backlash is inevitable. The

rampant disease mongering, the mass drugging of

schoolchildren with amphetamines, the false claims of

drug ads, the bribery of doctors, the collusion at the

FDA... it's all coming to the surface now, and by the

time this house of cards comes tumbling down, the

resulting criminal trials against drug company

executives and FDA officials will make the Enron

trials sound like a high school debate.

 

It is not only inevitable that drug company executives

and FDA senior officials will do prison time for their

crimes against humanity, it is important that they be

loudly condemned via such punishments for knowingly

defrauding, harming and ultimately killing countless

Americans in exchange for one thing: Corporate

profits.

 

American medicine is now the shame of the world, and

the conduct of senior officials at the FDA is nothing

less than criminal. There is now no greater threat to

the health and safety of the American people than the

U.S. Food and Drug Administration.

 

" As currently configured, the FDA is not able to

adequately protect the American public. It's more

interested in protecting the interests of industry. It

views industry as its client, and the client is

someone whose interest you represent. "

 

- Dr. David Graham, senior drug safety researcher at

the Food and Drug Administration, and Vioxx

whistleblower

 

 

All content posted on this site is commentary or

opinion and is protected under Free Speech. Truth

Publishing LLC takes sole responsibility for all

content. Truth Publishing sells no hard products and

earns no money from the recommendation of products.

Newstarget.com is presented for educational and

commentary purposes only and should not be construed

as professional advice from any licensed practitioner.

Truth Publishing assumes no responsibility for the use

or misuse of this material. For the full terms of

usage of this material, visit www.NewsTarget.com/terms.shtml