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  • E-Articles - Doctors And Patients Held Hostage

    You've said it! You've thought it! How much pain medication is enough? The truth is that each patient is born with or develops their own unique pain threshold and tolerance. Supposedly, your medical doctor has been given the licensure to prescribe the right dose level for you.

    We are talking about chronic pain problems here. Ones that drag you into depression, suicidal thoughts, hopelessness, and is
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    olation. You can't live life suffering with intolerable chronic pain. Nobody can.

    Seeking chronic pain relief becomes the one and only concern of any patient with chronic pain. All normal living patterns take second place.

    Now, if that doesn't get your dander up, what will?

    Have you experienced these barriers to your pain treatment?

    • Your very own doctor refuses to give you enough
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    pain medication to make you comfortable enough to go about your daily living chores.

    • Obtaining refills of prescription pain medications, especially narcotic drugs, is a major battle.

    • You are considered a narcotic addict by family, friends, and your doctor.

    • Floods of addiction warnings hit you from every direction.

    • Repeated intimidation and insinuations by health care provider
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    s about your use of pain medication brings you to your knees.

    • You are considered a liar and manipulator first, and a chronic pain sufferer patient secondly.

    • Has anyone taken the time to find out how much pain medication is enough for you?

    And you wonder why all this is being put on you when you don't deserve it? It's so easy to get good strong pain medication for a sprained ankle, but not for persistent pain. If
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    you think there is a lot more going on behind the scenes, you are right!

    It isn't you or your doctor that decides how much pain medication is enough---the DEA (Drug Enforcement Agency) and Medical Boards (appointed by the state governors) are taking over the job.

    They work under the premise that many doctors over-prescribe narcotic pain medications that patients fool doctors into doing, and then patients purpo
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    sely use the medications for street drug business. Your medical doctor is equated with a street drug trafficker.

    The government fight against illegal drug traffic steers right down through your doctor to your low back pain problem.

    How does the DEA find out about a doctor over-prescribing narcotic pain medication?

    1. Pharmacists report
    to the DEA all unusual (let's say---what they personally believe to be amounts of n
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    arcotics that are well above what average doctors prescribe) narcotic over-prescribing practices by local doctors (for patients filling their prescriptions at their pharmacy).

    Although it is not public knowledge, there is an underground railroad of narcotic prescribing habits of doctors circulating among the local and regional pharmacies. Of course they'll deny it forcefully. Who could prove it?

    2. DEA investigations of narcotic addic
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    s that lead back to a doctor.

    3. DEA oversight of the doctor’s use of special approved narcotic prescription pads (issued in at least 8 states) they issue to doctors registered with the DEA (permits them to prescribe Schedule II narcotics).

    4. State Medical Board investigations of "borderline" doctors who repeatedly are in trouble with the board.

    Are many doctors caught over-prescribing? Research indi
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    cated in 1995 that 392 doctors were in violation, 11 were pursued, and one conviction resulted. It sure doesn't sound like much, but the impact is felt throughout the medical profession.

    Doctors are gun-shy of the DEA! Why? Because most doctors are not aware of being investigated for over-prescribing narcotics. Suddenly one day federal agents invade the medical office, conf
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    iscate all records, and threaten the doctor.

    Being blindsided like this commonly ruins the doctor's reputation, destroys the medical practice, and includes Medical Board punishment---even if the doctor is later vindicated of all suspicion of wrong-doing.

    If you were a doctor, would this scare you enough to restrict narcotic prescribing, or even quit prescribing them altogether? Destruction of a doctor's professional ca
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    reer is a powerful motivation not to prescribe narcotics.

    What do patient do?

    • Join chronic pain message boards and forums on the Internet.

    • Rely on non-prescription pain medications that rarely help.

    • Find a doctor willing to take a risk and prescribe narcotics for your pain.

    • Many reach the hopelessness phase and contact any doctor who believes in PAS (patient
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    assisted suicide).

    • Join other forums on the Internet having to do with discussions of pain treatment such as a pain relief forum.

    • Try every form of alternative medical treatment (acupuncture, hypnosis, meditation, etc.) for pain.

    • Search for strategies for coping with chronic pain and illness from all sources.

    Anyone who tells you to, "learn to live with your pain,"
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ng> has never been in chronic pain. They might even need a bodyguard if they say it to you again!

    Patients join chronic pain message boards and forums and discover from other patients strategies for coping with chronic pain and illness. Even pain relief forums are beneficial for educating chronic pain sufferers.

    Many more patients die (or destroy their health) from over-dosing with non-prescription (alternative) pain drugs than from u
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    sing narcotic or prescription pain medications--a fact!

    Tylenol can destroy the liver. Aleve, ibuprofens, and aspirin compounds can cause stomach and intestinal bleeding with ulcers. One study revealed that alternative medications kill 17,000 pain patients a year. That's impressive!

    Narcotic pain treatment can addict you, but it doesn't kill you.

    Want to know the truth about addi
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    tion to narcotics? First, two kinds of narcotic (opiate) addiction exist---psychological and physiological.

    Physiological addiction is that which occurs with the use of narcotic pain medication for treatment of "REAL" pain. When the medication is no longer needed, you taper off the usage and are back to normal.

    Psychological addiction is the narcotic addiction a person depends on to escape r
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    eality and problems of life that they can't face and handle. Stopping the medication releases them back into the insurmountable turmoil of life that they use the narcotics to cover up.

    It's a brain verses pain difference.

    Advice:

    • Join chronic pain message boards and forums on the Internet and communicate with other chronic pain patients who are in the same boat as you. Pain relief forums lead patients to new forms
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    of treatment for chronic pain.

    • Use these forums to discover strategies for coping with chronic pain and illness. You may find the one or two treatments you haven't thought of. Sometimes patients stumble on to the secondary added on treatment that potentiates the effectiveness of the narcotics.

    • Remember to be persistent in your search for chronic pain relief. There are doctors out there who will help you.
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    g>Most will!

    Anyone with chronic pain who doesn't believe that they are being held hostage by the DEA and Medical Boards must believe that their sacrifice is more important than living itself---and must be a DEA or Medical Board employee.

    I understand that saying all these things may put me at risk because I am a medical doctor. Those doctors in practice couldn't and wouldn't write these comments for the general publ
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    ic to read because of repercussions that would follow. Wake up folks! The "1984 Big Brother" era is here.

    If you have the same concerns as I do, make your thoughts known. Don't let the DEA tell you how much pain medication is enough.

    References:

    1. http://orthopedics.about.com/cs/paintreatment/a/chronicpain_4.htm

    2. http://www.painmanagementdirectory.com/Results.aspx?query=Pain Management&sessionid=dhtm0m454jsq2
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    155cdszm3mm&cc=us&ns=1

    Pain management directory

    3. http://www.druglibrary.org/schaffer/asap/DEADLYM.htm

    4. http://www.druglibrary.org/toc.htm

    Links to hundreds of government reports/articles on pain meds.

    5. http://www.webmd.com/hw/pain_management/tr2775.asp

    6. http://www.medscape.com/viewarticle/405853_print

    7. Yeoman, Barry, "Prisoners of Pain" AARP

    Health Report, pp 54:Sept.-Oct. 2005

    Doctors fear FDA and prosecution for prescribing pain meds


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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