PROMPT Challenges PROP’s Petition

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PROMPT Challenges PROP’s Petition in Practical Pain Management, October 2012.
See HTML HERE on PPM’s website and see related articles.

PRACTICAL PAIN MANAGEMENT dedicated a significant portion of their October 2012 issue to the PROP petition, the founding of PROMPT and the  reasons for PROMPT’s materialization.  It is available online at Practical Pain Management’s website HERE.  They did not however include all of the information on their website that was included in the printed version.  if you wish to see the entire portions dedicated to PROP vs. PROMPT, please contact Dr. Fudin through this website.

Per the October 2012 Practical Pain Management Journal, “To further explore these two views of opioid safety, Practical Pain Management invited representatives from both camps—Dr. Fudin and Dr. Kolodny—to write commentaries, which began on page 12. In addition, PPM recently surveyed our editorial board members and asked for their opinions on the subject. A sampling of the board’s responses can be found on page 17.”

Background:

Professionals for Rational Opioid Monitoring & Pharmacotherapy (PROMPT) is a multidisciplinary group of clinicians, researchers and academicians from various fields. Some include areas of Addiction, Anesthesiology, Pain, Pharmacy, Primary Care, Psychiatry, Psychology, and various Board Certified specialties.  PROMPT’s materialization was a direct result of another group, Physicians for Responsible Opioid Prescribing (PROP) that submitted a Citizens petition to the FDA on July 25, 2012 requesting label changes for opioids.  A copy of our PROMPT reply to the FDA can be seen HERE.

We (PROMPT) are in favor of mitigating opioid risks with appropriate proactive and ongoing validated interventions intended for the benefit of patient care and public safety. We advocate for clinician education, proactive risk stratification, and appropriate therapeutic monitoring.

#PROMPTisreal

 

 

18 thoughts on “PROMPT Challenges PROP’s Petition

  1. Opioids are one tool, not the only tool, and we must all realize and incorporate into our clinical being this fact. Further, we must acknowledge that chronic pain is very, very complex. We minimize the complexity when we spend so much time focusing on one modality, whether opioids, interventions or other modality. Further we reduce our chances of successful treatment when we focus on one modality. Chronic pain patients have a multitude of co-morbidities, psychiatric issues, etc… beyond diversion, abuse, misuse and addiction; although these are obviously very important issues and must be dealt with. Further, I have been thinking about treatment in Europe. Since the US uses over 90% of the worlds opioids, do they have better, same or worse outcomes for their chronic pain patients? From what I read, about the same, so this should give us pause (admittedly the studies are difficult to compare for a variety of reasons). Although I use opioids for my patients, I have become much less sanguine about their use as the years have progressed, as I believe every pain practitioner should be.

    For those who keep saying we must do something about the issue of prescription drug overdose deaths and abuse, and for those legislators whose only interest seems to be in airtime and re-election funds, where are the increased funds for in-patient addiction treatment. Where is the call to increase reimbursement for outpatient treatment clinics? Where is the increased research monies to examine old and new treatments for chronic pain.

    Unfortunately, the PROP proposal is just a continuation of the “death of medicine as I knew it”. We, HCPs who actually practice on real patients, no longer have the time necessary to treat such complicated patients. Unfortunately, they will continue to be marginalized even further as physicians and other HCPS (those who actually do the work) have reimbursements cut, treatment options eliminated and increased regulation. You cannot approach these patients by focusing on the “primary complaint”, sorry AAPM and APS, neither can you with one modality; it is linear thinking in a non-linear clinical world. This takes a tremendous time investment, something apparently not valued in our current over regulated medical world.

  2. I am living proof that opioids when taken properly are not the cause of deaths, I have responsibly taken 240mgs of oxycodone for 15 years and i am fully healthy thanks to my medications I have enjoyed the past 15 years without having severe pain in my back.

  3. I just read all of the new articles posted on practical pain management. They were all excellent. Where is the article by Kolodny? I’m a big believer in know thy enemy. I wanted to read his article in practicle pain management.

    1. Andy,

      There wasn’t an actual article written by Dr. Kolodny; instead there was an interview. It doesn’t appear that the electronic version of the online journal has all of the related articles. The printed version however had much more. I will send it directly to you via email. If any readers are interested, let me know.

      1. Dr. Fudin , thank you for e-mailing me the interview. It was well done. The other articles were good too. I liked reading the opinions of health professionals on the PROP petition. I was disappointed, but not surprised, that Kolodny just kept repeating his previous position and talking points. It seems like the members of PROP never really engage in any type of meaningful debate.

  4. I absolutely loved the article. It was well written and clear. You did a wonderful job Dr.Fudin and I cannot wait for the new issue of Practical Pain Management.

    There are a few things about PROP that I would like to note though.

    1) It is unbelievable the number of scientific and philosophic mistakes made by PROP. It is almost hard for me to believe that the members who formed PROP and wrote the citizen petition are doctors. Basic science and philosophy dictate that you cannot quantify a subjective experience, yet that is a significant part of the PROP petition. Furthermore, the members of PROP have created a caricature and straw man of CNCP patients. They basically behave as if all CNCP patients are addicts whose pain is psychological( a.k.a. made up or fake). They behave as if CNCP patients are in need of “detox and rehabilitation.” The PROP members also endorse the idea that the absence of evidence is equivalent to the evidence of absence. I highly recommend that all the members of PROP enroll in undergraduate philosophy classes at the nearest university.

    2) Some members of PROP, like Ada Giudice and Pete Jackson will never change their minds because their children have passed away from the use of opioids. One of which did so in a verifiable illegal manner. They are understandably bitter and want to force their idea of “morality” and “safety,” in regards to pain medications and treatments onto the whole community of CNCP patients no matter the cost or collateral damage. They are trying to turn a negative situation into a positive and that would be very hard to do in their minds if the PROP petition is abandoned or changed. Here are the links supporting this point:

    i) http://www.novusdetox.com/press/dependence.php?include=140374
    ii)http://www.novusdetox.com/press/dependence.php?include=138022
    iii)http://oxywatchdog.com/wp-content/uploads/2012/01/ARPO-Hydrocodone-Letter.pdf

    3) While the FDA will probably ignore their requests, PROP is interacting with at least two members of the U.S Congress who agree with them. PROP is influencing and cooperating with Congresswoman Mary Bono Mack and Senator Tom Udall. Here is a link that shows some of what I claim in this point:

    http://bono.house.gov/uploadedfiles/mbm_ondcp_recs_7_20_12.pdf

    1. I am new to this discussion, since Kaiser Northern California has just instituted a policy of denying all opioids, at any time, to patients in chronic pain from serial failed orthopedic surgeries, even hydrocodone 5mg/APAP 325 mg; PO QHS; #30.
      Haven’t Bono-Mack and Senator Udall now been defeated at the ballot box, and are no longer in office?

      Also, I just read the 2012 PROP petition. I noticed 11/32 signatories are from Washington State; where assisted suicide is legal. These PROP proponents apparently want to be sure you do not have adequate pain medication to live, but are happy to provide medication to kill yourself if you cannot live with the pain anymore. What a twisted perspective!

  5. Just say for sake of argument that opiods kill you within 10 years of use. If you have intractable pain or chronic severe pain and can’t live/can hardly breathe without the medications…you won’t live 10 years anyway. So ……if you have a simple backache or headache take aspirin. If it’s serious chronic pain…and the pills help you move some you are ahead of the game. And I too have met cancer patients who’s pain was not as severe as some other people’s that I’ve met. To solve these problems we need unbiased, knowledgable doctors who understand pain and treatments. Not politicians. I understand there needs to be laws as some doctors are abusing their licenses. But when it’s well known that pain patients are suffering/dying something is wrong with the current plan. Sick people should not be denied. I was denied my regular pain meds in a hospital for another reason!!!! And I had a fax from my pain doctor of my exact meds etc. The hospital wanted to deny me anyway! Of course I am going to file charges against them for this. But why would they even consider cutting medications from a patient like that? And tried to give me other pain meds that were not in my pain contract. Had I taken those pills my pain doctor would have stopped treatment! This sounds insane doesn’t it? Yes…to me too! Oh …after I called the hospital’s administration office they came and I did finally get my regular medications. My reason for being in the hospital has NOTHING to do with pain or my medications. Nothing at all. Pure discrimination! Sad to think a hospital would treat people like this!

  6. “I wanted to make some points to PROP’s Petition and lets see what we can make of it by comparing what it is they say to what we really know.” Mark S. Barletta.

    2. Prescribing of opioids increased over the past 15 years in response to a campaign that minimized risks of long-term use for CNCP and exaggerated benefits.

    “My thoughts,the population has also increased putting much more people at risk of becoming a chronic pain sufferer.”

    3. Long-term safety and effectiveness of managing CNCP with opioids has not been established.

    “Whom did you ask this question ,just anyone that’s never suffered from chronic pain, they cant establish any answer if they have never suffered on a daily basis.
    Only those that suffer from chronic and intractable pain have established relief from their paralyzing chronic pain by following doctors orders and safely taking opiates as prescribed. We that suffer from chronic pain have finally found a way out of the never ending suffering ,why would PROP deny us pain relief.”

    4. Recent surveys of CNCP patients receiving COT have shown that many continue to experience significant chronic pain and dysfunction.

    “Yes this is correct once a chronic pain sufferer always a chronic pain sufferer, if surgery took our pain away we would have it but this is not available for me or people like me. I was told by many Surgeons and Pain Experts ,you cervical spine cant be surgically repaired, you will suffer the rest of your life. Stay with Pain Management, its your only option.”

    5. Recent surveys using Diagnostic and Statistical Manual of Mental Disorders or DSM criteria found high rates of addiction in Chronic Non-Cancer Pain or CNCP patients receiving Chronic Opioid therapy or COT.

    “Chronic Opioid Therapy is used for Chronic – Non Cancer Pain patients so they don’t have to suffer and be paralyzed with chronic pain curled up in bed .
    Most all never become addicted to these life saving medications, just somewhat dependent upon the medications so we can return to a Active Member of Society instead of suffering every day. Addiction is the misuse of opiates despite harm. All chronic pain patients are already harmed by the never ending chronic pain that confines us to our homes. We need freedom from our pain ,after all America is Land of the Free Home of the Brave.”

    6. A large sample of medical and pharmacy claims records found that two-thirds of patients who took opioids on a daily basis for 90 days were still taking opioids five years later.

    “That’s why it called intractable and chronic ,its not going away,so this is a fine example of why we need COT, this helps us live a somewhat normal life.”

    7. Patients with mental health and substance abuse co-morbidities are more likely to receive COT than patients who lack these risk factors, a phenomenon referred to as adverse selection.

    “Adverse selection, anti-selection, or negative selection is a term used in economics, insurance, statistics, and risk management. It refers to a market process in which “bad” results occur when buyers and sellers have asymmetric information (i.e. access to different information): the “bad” products or services are more likely to be selected. A bank that sets one price for all its checking account customers runs the risk of being adversely selected against by its low-balance, high-activity (and hence least profitable) customers. Two ways to model adverse selection are with signaling games and screening games.
    How this equates to those that suffer from chronic pain, I don’t see the link. I thought we where talking about chronic – non cancer pain and the medications that give us a life worth living without suffering.
    Is this how PROP views all people that suffer from chronic pain as BAD PEOPLE.”

    8. Three large observational studies published in 2010 and 2011 found dose-related overdose risk in CNCP patients on COT.
    9. COT at high doses is associated with increased risk of overdose death, emergency room visits and fractures in the elderly.

    “ As with all medical treatments of any kind of medical disorder risk are involved, there is no guarantee’s in life ,we must live life to the fullest extent.
    Every day we get in our car there is a risk of a bad accident. If we can prevent the suffering of good people why not give them what they need to survive another day,life is just way to short to cut people off of medications that can give them a better quality of life.
    Limiting opioid medications is like saying your better off suffering, isn’t life cruel enough for those in never ending chronic pain.
    Putting dosage limits on opioids is like taking the caffeine out of coffee why drink it, why go on suffering yet another day in never ending chronic pain.
    This is cruel and unusual punishment for those that never asked to be in chronic pain in the first place. Can we all please stop the slander and get along.
    We gain nothing by arguing amongst ourselves, it just causes stress we all don’t need. That tightening you feel in your chest is stress getting worse each day that passes,why make it any worse. Thank you,

  7. Thank you for allowing us, Chronic Pain patients, to be heard! I am still bewildered that just having Cancer is the only painful condition in PROP’s eyes worthy of managing and/or even discussing pain mgmt options. I have known several people that have had cancer, half have died, but more then half did not even have pain bad enough until it was the very end. So by just having cancer does not automatically mean severe intractable pain.

    I have always said that at least with terminal cancer, you know that the pain is going to stop. There are genetic conditions and diseases, or victims of horrible accidents or abuse that are left trying to literally pick up the pieces and live some kind of life. Having metal plates and bone infections in your face, with several reconstructive surgeries, is really, no walk in the park. Especially when the corrective surgery to save your life ends up damaging major facial nerves and you are left in more pain then you ever started with, even when I was first assaulted.

    I am already hearing of more and more suicides, of those not able to get their medications. Is that really caring and compassionate to stop treating or not treat at all someone that only wants to live? It is extremely hard to live when you have such pain every other moment of the day that you cannot even brush your teeth or other basic hygiene. I know what it is like to live like that, but with medications, I am able to live and contribute to my family life. Without a doubt, if PROP gets their way, I will be just another statistics, another one that just couldn’t take one more day–and why? Because a group of ‘doctors’ that have never really dealt with pain head on, are deciding what is best for me, instead of my doctor. What kind of EGO TRIP ARE THESE PEOPLE ON? They know SO MUCH BETTER then my Doctor that has studied pain and medications most of his life–yet he has to be fearful of the politicians and inflated egos of other power hungry ‘people’, not doctors. Shame on them all.

    1. Barbie, E11,
      I’m sorry you two have to suffer so much, right when I think my chronic pain is bad I read your stories and I don’t feel so bad after all. I know there are millions of people out there that suffer much more than me and I feel bad for them. I really don’t think this petition will fly so don’t get worked up ,its just making your pain worse than its needs to be.
      If I could fix your pain and make it go away I would but the next best thing is willing your pain away to a higher entity. I know that sounds a little odd, but try stepping aside yourself and leave that suffering body beside you and walk on past that pain, leaving it behind you for a while, step on over to the other side. It worked for me more than a few times. I use to think suffering was something I needed to go through to get where I need to be . I was so much older then, I’m younger than that now.

      1. Mark, thank you for your concern. I do, indeed, spend a majority of my time praying for others. This benefits them and keeps my eyes off myself and onto God. What people don’t realize about me is I spent 51 years fighting through pain that grew so severe I couldn’t be touched or jostled. My husband is the greatest man on earth for the years we lost…when touch was a kiss or our fingertips touching was enough. Opiates helped me live again and my husband (Mark) and for 3 years I have been doing fun things like motorcycling through the countryside. My husband deserves a wife with somewhat controlled pain! You see, love is not a feeling, it’s an action. Affection is the feeling behind love and for 33 years we have had both. Only God could sustain us, and if opiates are denied me, only God can get me through it. I appreciate the advice, and yet mind over matter takes too much concentration when you have neuropathic pain as well as the pain of VEDS, and other illnesses. I hope you will research VEDS, ankylosing spondylitis , RA and see the combination of pain I’m fighting. My MD/PhD geneticist said my immune system hates me and I’m going to die. I will die fighting pain if something isn’t done to help people like me.

  8. Thank you for championing appropriate opiate usage for people like me who have rare diseases. I was diagnosed with 3 genetic diseases, one of which is not only horrific, pain-wise, but fatal. It is a collagen vascular disease called vascular Ehlers-Danlos Syndrome; causing less to no collagen (the glue that holds us together) and weakened vasculature (causing excessive bleeding, anemia, varicose veins at an early age (14 for me), thin skin, poor wound healing, broken blood vessels, and a variety of other awful symptoms. One other disease affects the lower lumbar spine and sacrum, ankylosing spondylitis, as well as Central Sensitization Syndrome. Now I have inflammation in my hands and my joints are swollen and disfigured. I had two severe car accidents: the first when I was stopped in traffic and hit from behind by an 18 wheel semi, the second when I was t-boned by an elderly lady with Alzheimer’s. Despite this, I only sought pain care 3 years ago after I clenched so hard from the pain that I broke several teeth that had to be crowned. Imagine my surprise when my current pain doctor was suddenly forced to return to his native country and the pain practice stopped chronic pain management. So, now I am not only in terrible pain, I also have to find a pain doctor.

  9. I know there is a problem with people who abuse pain medications ,this will always be and there is not much we can do to curb the misuse of these life saving medications for those that suffer from chronic pain. After viewing the changes PROP wants to make I see no reason to bring up such changes because it will just harm those who need help from these quality of life medications.These medications made all the difference in the world to my quality of life after suffering for 10 years. The only way these medications can harm you is if you don’t follow directions by your doctor . So PROP think about the quality of life issues your brining upon people who need these medications the most. Don’t let drug addicts ruin quality of life issues for all that suffer from chronic and intractable pain . For every reason you give me as to why these medications should be used at quantity limits, I can give you 3 reasons why your wrong .
    There is no easy fix for the people who don’t really need these medications and abuse them putting their life at risk. Each and every time someone takes pain medications not prescribed to them it sets bad example for all involved. Don’t set your sights on all people that depend upon these medications to live a somewhat normal life, we’ve suffered long enough, move on to something that really helps and not harms all that suffer from chronic pain.
    This petition is a slap in the face to all pain patients that take these quality of life medications and the doctors that prescribe them.
    I’m appalled at PROP’s utter disregard for the suffering of the United States. Land of the Free and Home of the Brave. Yet we are not free of the Chronic pain that confines us to our homes.
    Pain patients in Florida cant even get their scripts filled, this only harms and does not help those in need of pain relief.

    With regards to all that suffer from cancer and NON-CANCER chronic pain.
    Mark S. Barletta

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