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Thread: Final Appeal: Please Help Me! Please! Dr. Young?

  1. #1
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    Final Appeal: Please Help Me! Please! Dr. Young?

    I've been working on my Fentora medication refill for months now. It's been denied now 3 times. This is my last appeal coming up before an ALJ (Administrative Law Judge). First, I must mail in my reasons I feel I need the drug, etc. etc. I have done this 3 prior times and I thought I had effectively postulated the reasons this drug is desperately needed. I guess they either found my reasons unsubstantial or did not bother really reading it (they marked my age "30" - I am just turned 20!).
    I am begging you with greater wisdom and intellect than I to please offer suggestions or citations, ANYTHING. Doctor Young, is there any material I could include that would, in your determination, sway your opinion? Or, anybody who has been thru the appeal with the ALJ.
    Many heartfelt thanks to ANYONE who can offer me a little advice/support. This entire process has left me depressed and nauseated.

    Thanks Again,
    Micha

  2. #2
    Micha,

    Dr. Young will give you the best advice, but I feel for you. Here is one idea for an opening statement.

    Your honor:

    With central pain, we are dealing with a disease that the public knows nothing about. It is notoriously difficult to treat at all, with any mediation. For a fortunate minority, a medication that works can occasionally be found. That is the case in my situation. However, I have had central pain long enough to know that a case such as this is NEVER about me. It is always about Central Pain and whether it exists. Its name is benign, but it is acknowledged to be the most severe pain state known to man. (Pick off the internet a few articles to hand to him). I know your honor does not have time to read these scientific articles. It is however essentail to know that this very unique, difficult to treat pain state exists. If the court accepts that it exists,and that experts struggle to find drugs which can control central pain, then it can only logically flow that I need this medication. I ask your honor to suspend judgment on my need for a treatment until the court has satisfied itself that central pain actually exists. Once the court is comfortable with that proposition, then I feel certain the court will conclude that if someone with this condition has managed to find a drug which helps. that it should be provided.

    you can probably say this better, but you get the idea. you are not insulting the judges intelligenc, rather you are handing documents which create an awarensss on the court's part. The websites devoted to central pain are one possible source. Pub Med has many articles on how difficult the therapy can be.

    My very favorite for this sort of thing is the piece Ron Melzack wrote in Scientific American in about 1989. You can excerpt the story about the young man who was on meds, got better, and then couldn't get them. That might be one article you would want to locate and highlight the story.
    Last edited by dejerine; 06-25-2007 at 04:10 AM.

  3. #3
    Quote Originally Posted by Michaela
    I've been working on my Fentora medication refill for months now. It's been denied now 3 times. This is my last appeal coming up before an ALJ (Administrative Law Judge). First, I must mail in my reasons I feel I need the drug, etc. etc. I have done this 3 prior times and I thought I had effectively postulated the reasons this drug is desperately needed. I guess they either found my reasons unsubstantial or did not bother really reading it (they marked my age "30" - I am just turned 20!).
    I am begging you with greater wisdom and intellect than I to please offer suggestions or citations, ANYTHING. Doctor Young, is there any material I could include that would, in your determination, sway your opinion? Or, anybody who has been thru the appeal with the ALJ.
    Many heartfelt thanks to ANYONE who can offer me a little advice/support. This entire process has left me depressed and nauseated.

    Thanks Again,
    Micha
    Micha,

    I don't know the details of your pain but I assume that it is neuropathic pain that developed after spinal cord injury. There is a small but growing body of evidence that opioid drugs can relieve neuropathic pin.

    A review article in the Journal of America Medical Association by Eisenberg, et al. (2005), concluded that intermediate term studies demonstrate significant efficacy of opioids over placebo for neuroapthic pain. While reported adverse events were common, they were not life-threatening. Further studies are required but this would seem to be ample justification for treatment of neuropathic. The benefits are real and the risks are not life-threatening.

    According to the Merck Manual, the oral or transdermal route is preferred for long-term use, that formulations of fentanyl are now available for delivery through the oral mucosa. Lozenges are used for sedation in children and effervescent tablets are available as a treatment for breakthough pain.

    In March 27, 2003, Kathleen M. Foley M.D. wrote a very influential editorial in the New England Journal of Medicine, concluding that opioids should be considered more often to treat neuropathic pain.

    Finally, Gilron, et al. (2005) reported that the combination of morphine and gabapentin achieves better analgesia than either of each drug alone. In 2006, Despande, et al. (2006) studied the effects of pain reduction in a clinical trial involving morphine, gabapentin, and morphine-gabapentin combination, finding that very significant effects of improving mood and quality of life.

    I don't know if this is enough for the judge but there are many other papers.


    Wise.

    1. Eisenberg E, McNicol E and Carr DB (2006). Opioids for neuropathic pain. Cochrane Database Syst Rev 3: CD006146. BACKGROUND: The use of opioids for neuropathic pain remains controversial. Studies have been small, have yielded equivocal results, and have not established the long-term risk-benefit ratio of this treatment. OBJECTIVES: To assess the efficacy and safety of opioid agonists for the treatment of neuropathic pain. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (2nd Quarter 2005), MEDLINE (1966 to June 2005), and EMBASE (1980 to 2005 Week 27) for articles in any language, and reference lists of reviews and retrieved articles. SELECTION CRITERIA: Trials were included in which opioid agonists were given to treat central or peripheral neuropathic pain of any etiology, pain was assessed using validated instruments, and adverse events were reported. Studies in which drugs other than opioid agonists were combined with opioids or opioids were administered epidurally or intrathecally were excluded. DATA COLLECTION AND ANALYSIS: Data were extracted by two independent investigators and included demographic variables, diagnoses, interventions, efficacy, and adverse effects. MAIN RESULTS: Twenty-three trials met the inclusion criteria and were classified as short-term (less than 24 hours; n = 14) or intermediate-term (median = 28 days; range = eight to 70 days; n = 9). The short-term trials had contradictory results. In contrast all nine intermediate-term trials demonstrated opioid efficacy for spontaneous neuropathic pain. Meta-analysis of seven intermediate-term studies showed mean post-treatment visual analog scale scores of pain intensity after opioids to be 13 points lower on a scale from zero to 100 than after placebo (95% confidence interval -16 to -9; P < 0.00001). The most common adverse events were nausea (33% opioid versus 9% control: number needed to treat to harm (NNH) 4.2) and constipation (33% opioid versus 10% control: NNH 4.2), followed by drowsiness (29% opioid versus 12% control: NNH 6.2), dizziness (21% opioid versus 6% control: NNH 7.1), and vomiting (15% opioid versus 3% control: NNH 8.3). Where reported, 23 (11%) of 212 participants withdrew because of adverse events during opioid therapy versus nine (4%) of 202 receiving placebo. AUTHORS' CONCLUSIONS: Short-term studies provide only equivocal evidence regarding the efficacy of opioids in reducing the intensity of neuropathic pain, whereas intermediate-term studies demonstrate significant efficacy of opioids over placebo, which is likely to be clinically important. Reported adverse events of opioids are common but not life threatening. Further randomized controlled trials are needed to establish long-term efficacy, safety (including addiction potential), and effects on quality of life. New England Medical Center, Pharmacy and Anesthesia, Box #420, 750 Washington Street, Boston, MA 02111, USA. ewanmcnicol@comcast.net http://www.ncbi.nlm.nih.gov/entrez/q..._uids=16856116
    2. Eisenberg E, McNicol ED and Carr DB (2005). Efficacy and safety of opioid agonists in the treatment of neuropathic pain of nonmalignant origin: systematic review and meta-analysis of randomized controlled trials. Jama 293: 3043-52. CONTEXT: In the United States, an estimated 2 million persons have neuropathic pain that is often resistant to therapy. The use of opioids for neuropathic pain remains controversial, in part because studies have been small, have yielded equivocal results, and have not established the long-term risk-benefit ratio of this treatment. OBJECTIVE: To assess the efficacy and safety of opioid agonists for the treatment of neuropathic pain based on published randomized controlled trials (RCTs). DATA SOURCES: We searched MEDLINE (1966 to December 2004) and the Cochrane Central Register of Controlled Trials (fourth quarter, 2004) for articles in any language, along with reference lists of reviews and retrieved articles, using a combination of 9 search terms for RCTs with 32 terms for opioids and 15 terms for neuropathic pain. STUDY SELECTION: Trials were included in which opioid agonists were given to treat central or peripheral neuropathic pain of any etiology, pain was assessed using validated instruments, and adverse events were reported. Studies in which drugs other than opioid agonists were combined with opioids or opioids were administered epidurally or intrathecally were excluded. DATA EXTRACTION: Data were extracted by 2 independent investigators and included demographic variables, diagnoses, interventions, efficacy, and adverse effects. DATA SYNTHESIS: Twenty-two articles met inclusion criteria and were classified as short-term (less than 24 hours; n = 14) or intermediate-term (median = 28 days; range = 8-56 days; n = 8) trials. The short-term trials had contradictory results. In contrast, all 8 intermediate-term trials demonstrated opioid efficacy for spontaneous neuropathic pain. A fixed-effects model meta-analysis of 6 intermediate-term studies showed mean posttreatment visual analog scale scores of pain intensity after opioids to be 14 units lower on a scale from 0 to 100 than after placebo (95% confidence interval [CI], -18 to -10; P<.001). According to number needed to harm (NNH), the most common adverse event was nausea (NNH, 3.6; 95% CI, 2.9-4.8), followed by constipation (NNH, 4.6; 95% CI, 3.4-7.1), drowsiness (NNH, 5.3; 95% CI, 3.7-8.3), vomiting (NNH, 6.2; 95% CI, 4.6-11.1), and dizziness (NNH, 6.7; 95% CI, 4.8-10.0). CONCLUSIONS: Short-term studies provide only equivocal evidence regarding the efficacy of opioids in reducing the intensity of neuropathic pain. Intermediate-term studies demonstrate significant efficacy of opioids over placebo for neuropathic pain, which is likely to be clinically important. Reported adverse events of opioids are common but not life-threatening. Further RCTs are needed to establish their long-term efficacy, safety (including addiction potential), and effects on quality of life. Pain Relief Unit, Rambam Medical Center, and Haifa Pain Research Group, the Technion-Israel Institute of Technology, Haifa, Israel. e_eisenberg@rambam.health.gov.il http://www.ncbi.nlm.nih.gov/entrez/q..._uids=15972567
    3. Foley KM (2003). Opioids and chronic neuropathic pain. N Engl J Med 348: 1279-81. http://www.ncbi.nlm.nih.gov/entrez/q..._uids=12660393
    4. Gilron I, Bailey JM, Tu D, Holden RR, Weaver DF and Houlden RL (2005). Morphine, gabapentin, or their combination for neuropathic pain. N Engl J Med 352: 1324-34. BACKGROUND: The available drugs to treat neuropathic pain have incomplete efficacy and dose-limiting adverse effects. We compared the efficacy of a combination of gabapentin and morphine with that of each as a single agent in patients with painful diabetic neuropathy or postherpetic neuralgia. METHODS: In this randomized, double-blind, active placebo-controlled, four-period crossover trial, patients received daily active placebo (lorazepam), sustained-release morphine, gabapentin, and a combination of gabapentin and morphine--each given orally for five weeks. The primary outcome measure was mean daily pain intensity in patients receiving a maximal tolerated dose; secondary outcomes included pain (rated according to the Short-Form McGill Pain Questionnaire), adverse effects, maximal tolerated doses, mood, and quality of life. RESULTS: Of 57 patients who underwent randomization (35 with diabetic neuropathy and 22 with postherpetic neuralgia), 41 completed the trial. Mean daily pain (on a scale from 0 to 10, with higher numbers indicating more severe pain) at a maximal tolerated dose of the study drug was as follows: 5.72 at baseline, 4.49 with placebo, 4.15 with gabapentin, 3.70 with morphine, and 3.06 with the gabapentin-morphine combination (P<0.05 for the combination vs. placebo, gabapentin, and morphine). Total scores on the Short-Form McGill Pain Questionnaire (on a scale from 0 to 45, with higher numbers indicating more severe pain) at a maximal tolerated dose were 14.4 with placebo, 10.7 with gabapentin, 10.7 with morphine, and 7.5 with the gabapentin-morphine combination (P<0.05 for the combination vs. placebo, gabapentin, and morphine). The maximal tolerated doses of morphine and gabapentin were lower (P<0.05) with the combination than for each drug as single agent. At the maximal tolerated dose, the gabapentin-morphine combination resulted in a higher frequency of constipation than gabapentin alone (P<0.05) and a higher frequency of dry mouth than morphine alone (P<0.05). CONCLUSIONS: Gabapentin and morphine combined achieved better analgesia at lower doses of each drug than either as a single agent, with constipation, sedation, and dry mouth as the most frequent adverse effects. Department of Anesthesiology, Queen's University, Kingston, Ont, Canada. gilroni@post.queensu.ca http://www.ncbi.nlm.nih.gov/entrez/q..._uids=15800228
      http://content.nejm.org/cgi/content/...ct/352/13/1324

  4. #4
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    dejerine and Dr Wise (very appropriate name, indeed! ),

    I thank you both deeply and from my heart. You have helped enormously.

    Micha.

  5. #5
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    The nature of my pain is 2-pronged: neuropathic & non-neuropathic, quite specifically, bone pain in my lower back/coccyx area. The neuro pain acts as a catalyst, serving to enhance my bone pain and make me suffer a general malaise in an excruiciating form. I was lucky, indeed. Imagine my elation when my crappy Part D paid for my overpriced (2,000$) medication! Then, imagine my despair when the pharmacist - my buddy! my pal! - told me after Jan.2007, Fentora was "pre-auth". This was my 2nd (or 3rd, or 8th.) decent into the fiery pits of hell. A place that now feels like a dreaded visit to a 2nd home I'm trying to take of the market. I digress... I'm going to have to buck-up (how DO I hate that saying), write this letter and say a little prayer to whomever looks after us pagan-Atheists that this AL Judge is a decent-hearted man and not a soulless a-hole who holds my destiny in his hands. Or, will hold, anyway.

    Micha.

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