• 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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