Originally published June 29 2006
The lawlessness of the FDA, Big Pharma immunity,
and crimes against humanity (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.
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
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