Merck to ask for OVER THE COUNTER ON STATIN

Discussion in 'Health and medical' started by Mfg, Dec 22, 2003.

  1. Mfg

    Mfg Guest

    From the LATimes, Dec 22, 2003 "Drugs and obesity drive trends in 2004"

    "Merck & Co., in a joint effort with Johnson & Johnson, says it will seek Food and Drug
    Administration approval to sell Merck's cholesterol drug, Mevacor, over the counter, some time next
    year. Three years ago, two companies, including Merck, sought approval to make their cholesterol
    drugs available without a prescription but were turned down. Statins are medications that lower
    cholesterol. In use for about 15 years, the drugs — there are many brands on the market — are
    considered safe and effective for most people. The time may be ripe for a change because doctors
    believe many more people could benefit from taking statins. (They already are one of the most
    frequently prescribed drugs). Also, federal regulators are interested in converting more drugs to
    over-the-counter status as a way to help reduce overall health-care spending.

    When the FDA turned down the companies' requests in 2000, regulators said one reason for the denial
    was that the dosage being sought for the over-the-counter statins — 10 milligrams — would be too
    low. It is likely that the companies will request a dosage of 20 milligrams if they reapply, said
    Merck spokesman Tony Plohoros."

    $tatin$$$$$$$$$$$$$$

    Hundreds of thousands of people have been injured by statins. They took this under-tested drug
    rushed onto the market for greed and profit because they were told it would help them. They were
    told it was safe. The manufacturers lied.

    Will there be thousands more injured when statins are bought over the counter? In 1989 Merck took
    out a patent on coenzyme Q10, knowing full well all statins, including their Mevacor, deplete this
    essential enzyme from our bodies. Still today, no statin includes coenzyme Q10. Will people buying
    their OTC statin know that they risk death, injury and permanent disability from the documented side
    effects of statins they take this drug? Many physicians who get their continuing education from
    pharma sponsored junkets remain ignorant of what these drugs can do. How then can we count on clerks
    at Wal Mart or the Esso station to offer counseling of possible statin-induced side effects such as
    muscle myopathy, myositis, rhadomyolysis, peripheral neuropathy, polyneuropathy, memory loss,
    aphasia, transient global amnesia, cognitive problems, ocular myasthenia and cardiomyopathy?

    Citizens Petition to Change the Labeling on all Statin Drugs
    www.fda.gov/ohrms/dockets/dailys/02/May02/
    052902/02p-0244-cp00001-01-vol1.pdf -

    Cardiologist Peter Langsjoen's letter accompanying the citizens petition:

    July 8, 2002

    STATIN-INDUCED CARDIOMYOPATHY

    INTRODUCTION TO THE CITIZEN'S PETITION ON STATINS

    By Peter H. Langsjoen, MD

    The medical profession has, after more than 30 years of excellent propaganda, successfully created
    the wholly iatrogenic - "pseudo-disease" dubbed "hypercholesterolemia" and the associated malady
    "cholesterol neurosis". After decades of dismal failure to cure this "disease" of numbers with low
    fat diets and a host of cholesterol lowering drugs, the medical profession stumbled upon the magic
    bullet, the cure for this dreaded artificial disease - statins (HMG-CoA reductase inhibitors). First
    released on the US market in 1987, statins have rapidly grown into one of the most widely prescribed
    class of drugs in history. Statins do three things:

    52903. They block the body's ability to make cholesterol, thus lowering the blood level of
    cholesterol, thereby curing cholesterol neurosis. Doctors and patients equally neurotic have
    immediate gratification. The "evil" high cholesterol has been dramatically lowered and the
    future is bright and promising. So far...so good.

    52904. Unrelated to their cholesterol lowering, statins have been found to have anti-inflammatory,
    plaque-stabilizing properties which have a slight benefit in coronary heart disease.

    52905. Statins kill people - lots of people - and they wound many, many more. All patients taking
    statins become depleted in Coenzyme Q10 (CoQ10), eventually - those patients who start with a
    relatively low CoQ10 levels (the elderly and patients with heart failure) begin to manifest
    signs/symptoms of CoQ10 deficiency relatively rapidly - in 6 to 12 months. Younger, healthier
    people who's only "illness" is the non-illness "hypercholesterolemia" can tolerate statins
    for several years before getting into trouble with fatigue, muscle weakness and soreness
    (usually with normal muscle enzyme CPK tests) and most ominously - heart failure.

    In my practice of 17 years in Tyler, Texas, I have seen a frightening increase in heart failure
    secondary to statin usage, "statin cardiomyopathy". Over the past five years, statins have become
    more potent, are being prescribed in higher doses, and are being used with reckless abandon in the
    elderly and in patients with "normal" cholesterol levels. We are in the midst of a CHF epidemic in
    the US with a dramatic increase over the past decade. Are we causing this epidemic through our
    zealous use of statins? In large part I think the answer is yes. We are now in a position to witness
    the unfolding of the greatest medical tragedy of all time - never before in history has the medical
    establishment knowingly (Merck & Co., Inc. has two 1990 patents combining CoQ10 with statins to
    prevent CoQ10 depletion and attendant side effects) created a life threatening nutrient deficiency
    in millions of otherwise healthy people, only to then sit back with arrogance and horrific
    irresponsibility and watch to see what happens
    - as I see two to three new statin cardiomyopathies per week in my practice, I cannot help but view
    my once great profession with a mixture of sorrow and contempt.

    Statin-induced CoQ10 depletion is the topic of a recent petition to the FDA requesting that this
    drug/nutrient interaction be identified in a black box warning as part of statin package insert
    information. A comprehensive review of animal and human trials addressing this issue has been
    submitted to the FDA as a supporting document. We, of course, do not expect any response from the
    FDA, but 10 years from now when the full extent of statin toxicity becomes painfully evident, at
    least we can, in good conscience, know that we tried and who knows, sometimes small sparks may
    spread in dry grass.

    See Also:

    Cholesterol Drugs And The Depletion Of Coenzyme Q10: A Review Of Human And Animal Data. By Peter H.
    Langsjoen, MD

    Citizen Petition: Needed - A Change In The Labeling Of All Statin Drugs
     
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