The Pharmaceutical Industrial Complex: A Deadly Fairy Tale

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It has been
a particularly bad month for the pharmaceutical industrial complex
in its ongoing litigations in American courts. Among the main pharmaceutical
headlines, Merck’s Gardasil vaccine for HPV, now being widely
administered to pre-teens, was found to be linked to amyltrophic
lateral sclerosis, commonly known as Lou Gehrig’s disease;
following a $1.4 billion fine in promoting one of its blockbuster
drugs Zyprexa off-label, deceptive correspondence was uncovered
by Eli Lilly gaming the system again by promoting another one of
its drugs, Cymbalta, off-label for fibromyalgia; AstraZeneca was
fined $160 million for scamming the Medicaid system in Kentucky
after being fined $215 million for ripping off Alabama; Glaxo lost
a Pennsylvania trial for failing to warn doctors and pregnant women
of the dangers of its antidepressant drug Paxil related to birth
defects; and Pfizer scored a record-breaking fine of $2.3 billion
for illegally marketing several drugs over the years: Bextra, Zyvox,
Geodon and Lyrica. These kinds of charges, among the many others,
have become a habit for drug makers for the past dozen years.

When we speak
of the pharmaceutical industry complex, it does not refer solely
to private drug manufacturers. The complex, like a Matrix that holds
captive the health of the nation in medical slavery by its own design
and manipulation, is a consortium, a spiders’ web woven with
financial attachments throughout the medical profession. In addition
to the pharmaceutical and medical device firms, this complex includes
every government health agency – the Food and Drug Administration
(FDA), the Centers for Disease Control (CDC), the National Institutes
of Health (NIH), and of course the Department of Health and Human
Services (HHS) – as well as drug lobbying firms now employing
a large number of former Congresspersons, insurance and HMO companies,
all of the leading professional medical associations such as the
American Medical Association (AMA) and the American Psychiatric
Association (APA), the majority of medical schools and their research
departments who are heavily funded by drug money, many of the most
prestigious medical journals, and ultimately all of this filtering
downward to the physicians who diagnose our illnesses and prescribe
our medications and treatments.

America is
rightly regarded as having led much of the world in many qualitative
innovations in all fields. That reputation is duly deserved. However,
there is a new dynamic at work that is causing this reputation to
be challenged. We are a nation that prides itself in our humanity,
our sense of fairness, but today there is a growing concern that
we are now being monikered as a country held hostage to a national
security complex, which includes the largest military complex in
the world, an obscenely expensive healthcare system and self-serving
bureaucracies and private industries that serve their own financial
ends. So it is not surprising that after spending this year $2.6
trillion on healthcare, we have such little health to show for it.
There are second world countries where people live longer and healthier
lives. And we have the worst healthcare among developed nations.
So what have we received for our $2.6 trillion.

As the current
healthcare debate continues to rage over in sundries – the
$200 billion net profit health insurance industry – the entire
deliberation over disease prevention and treatment has been overshadowed.
And amidst this partisan and ideological anarchy, perpetuated by
our elected officials, the media, and fueled by the pharmaceutical
complex, two other areas America excels as a leader above all other
developed nations is in being the premier breeding ground for the
pharmaceutical industrial complex’s greatest profits and, second,
as the world’s exemplar in medical fraud and corruption. The
fairy tale of America’s health as being best served by drugs
is a creation of this complex, a lullaby that brings ill citizens
repeatedly to their doctors and hospitals for diagnosis and treatment,
or simply to deny healthcare altogether to the uninsured.

The country
is pacified by a blind belief that the drugs being prescribed to
them have been proven safe because our government health agencies
have our physical health and well-being in their best intentions.
This is a lie, an extraordinarily deadly lie. Iatrogenesis, medically
induced injury and death, is the number one cause of death in American
medicine annually, since only a small percentage of these deaths
are actually reported. Each year more Americans die from preventable
deaths due to our medical system than all military causalities in
the two world wars combined. This is tantamount to medical genocide.
One of the major causes of these deaths is the overmedication of
Americans in all ages. The constant need for profits has created
an environment that allows the pharmaceutical industrial complex
to use their enormous financial and political clout to literally
make normal life experiences into new diseases, such as social anxiety
disorder, in order to sell its drugs. The pharmaceutical industry
has been given the authority to pathologize life, with the drugging
of our children, seniors, etc. For example, the leading cause of
AIDS deaths today is a result of liver failure. This is not a condition
of HIV infection, but a direct result of the anti-HIV drug AZT.
Is it little wonder then that we are being intimidated and frightened
into believing that mandatory vaccination is being touted even though
the science of efficacy and safety, even the need, for these new
swine flu vaccines is patently unproven. It is perhaps one of the
largest falsehoods ever perpetuated on humanity that dwarfs the
sleaze on Wall Street.

If any one
of us committed manslaughter, we would be behind bars instead of
walking a crimson carpet into the offices of our elected officials
in the Congress and Senate or past the gates guarded by the nation’s
Cerberus, Rahm Emmanuel, to lobby the White House. Yet if we are
a pharmaceutical executive, or a lobbyist representing a drug company
who has collected a litany of charges including medical fraud, criminal
salesmanship, gaming the insurance industries, repeated lying to
federal officials, and manipulation of data regarding life-threatening
adverse effects of drugs that have killed so many people, we can
walk away with a fine, a surge in the stock market after a settlement,
a financial bonus, and the personal satisfaction in not having to
apologize so we can continue business as usual. This is the power
the pharmaceutical industrial complex possesses and its usurped
right to distain every noble principle in the Hippocratic Oath that
every physician dedicates her or himself to live by, “That
I will exercise my art solely for the cure of my patients, and will
give no drug and perform no operation for a criminal purpose.”

Every American
who is prescribed a drug by a physician has the belief that that
pill has undergone rigorous trials to scrutinize its safety. And
when there are known potential adverse effects, we blindly assume
these are known to the attending physician. However, this is a myth
perpetuated not only by drug makers, but by our own federal health
agencies. A 2003 investigation published in The Independent in the
UK reported that “under pressure from the pharmaceutical industry,
the FDA routinely conceals information it considers commercially
sensitive, leaving medical specialists unable to assess the true
risks [of approved drugs].” One case involved a very popular
over-the-counter drug, the painkiller ibuprofen. The investigators’
search uncovered concealed data showing that ibuprofen increased
heart attack risks by 25 percent. Even Freedom of Information (FOI)
filings to the FDA do not produce all the information being requested.
For example, a group of Swiss investigators filed an FOI to procure
trial data about the musculoskeletal pain drug Celecoxib and received
back only 16 of the 27 trials conducted on it. A separate FOI concerning
a similar drug, Valdecoxib, had pages and paragraphs deleted because
sections of the document were marked as “trade secrets.”
An even worse case involving a leaked report concerning internal
memos and secret FDA reports provided detailed evidence that the
FDA approved 9 different antidepressants, representing a total of
22 studies enrolling 4,250 children, while knowing full well that
the risk of “suicide-related events” was twice as high
as children taking a placebo. These are just several examples among
numerous others.

The pharmaceutical
industrial complex is perhaps the largest, most influential cartel
in the world. This becomes evident after considering the billions
of dollars and other currencies drug companies have been forced
to pay for a wide variety of corruption charges. Our analysis of
724 legal settlements from a random sampling among the over one
hundred thousand by pharmaceutical corporations totally $87 billion
is just a small indication about how pervasive Big Pharma’s
criminality since the vast majority of settlements are concluded
outside of court and remain confidential.

It is extremely
difficult to comprehend why the United States' principle federal
health agencies, particularly the FDA and National Institutes of
Health (NIH), with the specific mandate to provide oversight on
all pre-approved drug applications and delegated with the task to
assure drugs are safe or at least specify clearly their known dangers,
are so reprehensible and inept. There is only one rational answer
and that is the pharmaceutical industry is the FDA’s largest
client, and this relationship goes much deeper than the FDA functioning
as an objective regulator investigating pharmaceutical products
before being released upon the American population. It is not to
far afield to suggest that as it stands now the US regulatory agencies
are an extension of corporate America.

As serial offenders
of product safety cover-ups for over a decade, drugs have injured
and killed millions. In the case Merck’s Vioxx, this one drug
has killed 44,000 people and injured 120,000 others. Only in America
could you kill 44,000 and not go to jail and get a raise. Should
we assume, therefore, that the pharmaceutical complex should be
trusted without challenge? We have also been asked to believe that
the manufacturers were guided by a sense of public service. But
when examining the top ten drugs sold, the facts reveal otherwise.
In one example, manufacturers marked up a drug an astounding 500,000%
over its equivalent generic version. Six other drugs were marked
up 2000%. Pharmaceutical companies make profits higher than oil
companies.

Big Pharma’s
impact is felt almost everywhere. But nowhere is it felt more than
in the legal system. In a recently concluded, short-term study,
we found 724 cases involving Big Pharma in which either the case
ended in a verdict against the pharmaceutical company or the company
settled. The number of cases is staggering, as are the dollar amounts.
These cases cover practically every type of civil and criminal case.
From products that kill, harm and maim, to false claims, to not
paying taxes, to patent infringements, to bribery, to publishing
false scientific journals. Yet, in spite of the tens of thousands
of lawsuits won against Big Pharma, it still conducts business as
usual.

Eli Lilly flooded
state Medicaid programs with Zyprexa: its superstar, antipsychotic
drug. In 2003, worldwide sales of Zyprexa grossed $4.28 billion,
amounting to almost one third of Lilly’s total sales. In the
United States, during the same year, Zyprexa grossed $2.63 billion.
A whopping 70 percent of these sales were directly related to government
agencies – principally Medicaid. Fast-forward six years to 2009,
Eli Lilly pleaded guilty for having illegally marketed Zyprexa for
an unapproved use to treat dementia, and will pay $1.42 billion
to settle civil suits and end the criminal investigation. Lilly
agreed to pay $800 million to settle civil suits. It will pay $615
million to resolve the criminal probe, and plead guilty to a misdemeanor
in violation of the Food, Drug and Cosmetic Act for promoting Zyprexa
as a dementia treatment.

Did Lilly also
know of the possibility that Zyprexa could cause diabetes, which
was also kept concealed under the protection of the FDA? They most
certainly did, which makes their behavior all the more reprehensible.
In 2002, British and Japanese regulatory agencies issued a warning
that Zyprexa may cause diabetes. In addition, even after the FDA
issued a similar warning in 2003, Lilly did not pull Zyprexa from
the market. This becomes all the more understandable after it is
taken into consideration that Lilly is also the largest maker of
diabetes medications.

An article
by Mike Adams, the Natural News editor, states that Merck employees
had a “hit list” of doctors they sought to “neutralize.”
This allegation was confirmed when documents that had been secret
were revealed during a Vioxx court case. The Australian revealed
that the documents surfaced in the Federal Court in Melbourne and
exposed the criminal intent of Merck employees who admitted they
were going to “stop funding to institutions” and “interfere
with academic appointments.” One Merck employee testified (about
the doctors on the hit list), “We may need to seek them out
and destroy them where they live.” Merck threatened or intimidated
at least eight clinical investigators, testimony in court revealed.
There are other, similar stories in which Merck deals with dissent
by attempting to destroy the lives and careers of academics who
don’t review their drugs favorably.

Merck is steeped
in a well-documented record of criminality. Such actions include,
but are not limited to, intentionally hiding the liver-damaging
effects of its cholesterol drug, intentionally withholding the release
of clinical data that revealed the failures of another cholesterol
drug; it has dumped vaccine waste and manufacturing chemicals into
water supplies; it opened up offshore banking accounts to avoid
paying billions of dollars in U.S. taxes, and it was caught in a
huge scheme of scientific fraud when it was discovered that the
company used in-house writers to secretly write so-called “independent”
studies that were published in peer-reviewed medical journals.

Under the Foreign
Corrupt Practices Act, which the U.S. Department of Justice and
the SEC enforce, it is illegal to bribe a foreign government official
in order to obtain or retain business. Apparently, Bristol-Myers
and Schering Plough were unaware of this law. According to the Associated
Press, both drug makers were engaged in influencing government officials
in Germany and Poland respectively.

Earlier this
year, an article in the Boston Business Journal reported that a
former drug company sales executive pleaded guilty in Boston federal
court to telling the roughly 100 representatives she supervised
that they should promote a pain drug for uses she knew had been
rejected by the FDA. Bextra was the drug she pleaded guilty to inappropriately
selling. Pfizer has since pulled it from the market. According to
a press release from U.S. Attorney Michael Sullivan’s office, “Holloway
was aware of the FDA’s safety concerns, but…she nonetheless had
her sales staff of approximately 100 employees sells Bextra for
precisely the uses that the FDA refused to approve.”

The pharmaceutical
complex has also infiltrated the majority of American medical schools
and medical research departments. A recent survey in the Journal
of the American Medical Association discovered that 60% of academic
department chairs have personal ties to industry (as consultants,
board members, or paid speakers), while 66% of the academic departments
had institutional ties to industry. Researchers who receive funding
from drug and medical-device manufacturers are up to 3.5 times as
likely to state their study drug or medical device works than are
researchers without such funding.

In America,
one can hardly turn on the television or pick up a newspaper without
reading about the hot-button issue of health care reform. Why such
emotion? Why are, seemingly, rational people so intransigent and
unwilling to budge from their positions? Could lobbyists have anything
to do with this? According to OpenSecrets.org, there are 3093 lobbyists
in the health field and Big Pharma now spends approximately $1.2
million daily to persuade Congress to act according to their script.
An investigation conducted by Medical Verdicts & Law Weekly
found that 30 key lawmakers are involved in health legislation totaling
$11 million in health investments. Three of every four major health
firms have at least one lobbyist who worked for a congressman. Startlingly,
nine lobbyists employed by Big Pharma are former congressional staffers
who are still well-connected to Capitol Hill. The conflicts of interest
are everywhere. Judd Gregg (R-NH), the Obama nominee for Commerce
Secretary, who withdrew because of opposition to the Administration’s
agenda, is a senior member of the Health Committee. He revealed
that he has $254,000–$560,000 in health stocks."

In 2000, Mylan
Labs settled a case for $100 million. What the numbers don’t
tell you is the story behind the numbers. In 1998, Mylan raised
the wholesale price of clorazepate, a generic tranquilizer, to $377.00
(for 500 tablets) from $11.36 in one year. This represents a 3000%
increase on a generic drug.

It was subsequently
revealed that Mylan conspired with the main manufacturer of the
active, indispensible ingredient to have an exclusive agreement.
The agreement prevented any other manufacturers from producing the
drug, for without the active ingredient, the drug could not be made.
Mylan’s deception was uncovered and it had to pay $100 million
to settle an FTC antitrust case. But Mylan represents only an infinitesimal
percentage of such examples. In all likelihood, the vast majority
of similar cases remain undetected. The FDA’s under-regulation
and erroneous oversight encourages this type of corruption.

Another case
included in our study states, “TAP [Taketa-Abbott Pharmaceutical]
Pharmaceutical Products Inc. – $875,000,000 under the False Claims
Act.” TAP agreed to pay $875 million to resolve criminal charges
and civil liabilities in connection with its fraudulent drug pricing
and marketing conduct regarding the drug Lupron, according to a
press release from the Department of Justice. Lupron is used by
male cancer patients to suppress the production of testosterone.
Another drug worked as well, so to make Lupron the drug of choice
for this condition, TAP played dirty by giving kickbacks to physicians
prescribing the drug, thus ensuring its ridiculously high price
would be maintained. Even though criminal indictments were filed
against TAP Pharmaceutical officials, Lupron’s price remains
overly inflated.

Read
the rest of the article

October
23, 2009

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