The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity (op

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The lawlessness of the FDA, Big Pharma immunity, and crimes against

humanity (opinion)

 

 

Thursday, June 29, 2006 by Mike Adams, Key concepts: the FDA, Big

Pharma and prescription drugs.

 

 

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?

Related book:

Dangerous Medicine Message Board

Bulletin board site for posting your horror stories about harmful

prescription drugs, hospital stays, surgical procedures and medicine

gone bad. Post your true story and read others now!

 

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.