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The Lawlessness of the FDA,
Big Pharma Immunity, and Crimes Against Humanity - by Mike Adams
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
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
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
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
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
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:
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
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