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
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
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 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
"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
- Dr. David Graham, senior drug
safety researcher at the Food and Drug Administration, and Vioxx whistleblower
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