The Great Opioid Divide: Written and Sealed

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At Pain Week it was written; on this blog it is sealed.  After much introspection of the original agenda as partially outlined in Two “Chairs” for PROMPT, the revised version of what was originally to be an “all out” PROP-PROMPT debate finally happened at Pain Week 2013 on September 6th.  The revised style was entitled, “The Great Divide: the Debate on Long-term Opioid Prescribing for Chronic NonCancer Pain”.  Anticipation by the attendees on this hot topic was reflective by the turnout; it was standing room only with approximately 650 registrants.  The discussions were delayed so the Great Wall could be opened to accommodate overcrowding, eerily analogous to the many non-attendees that were in their own communities repenting for sins from the past year. 

Regardless of the forum, it is clear to most that the highlighted issues became prominently visible following mass media attention given to the obvious divide that surfaced between Physicians for Responsible Opioid Prescribing(PROP) and  Professionals for Rational Opioid Monitoring and Pharmacotherapy(PROMPT).  Reflecting over the past year, these two groups became so dichotomous, it was indicative of biblical xenophobics.

The forum began with an introduction by Dr. Daniel Carr who provided a general overview of how the session would be laid out and an introduction of the expert panel, all who were seated comfortably on the bema.  There was no room for the empty chair originally intended for Dr. Andrew Kolodny who did not participate for various reasons.  The purpose of this session was and remained to provide quality education on the issues, not specifically to endorse or assault one group over the other.  Dr. Carr aptly quoted Maimonides (1135-1204 C.E.), “If anyone declares to you that he has actual proof, from his own experience, of something that he requires for the confirmation of his theory – even though he be considered a man of great authority, truthfulness, earnest words and morality – yet, just because he is anxious for you to believe his theory, you should hesitate”.  Ironically, PROP’s founder Dr. Kolodny, until recently was for many years employed by Maimonides Medical Center. How apropos then that this debate occurred on the second day of Rosh Hashanah and Maimonides was a rabbi, physician, and philosopher.  In keeping with the Holiday theme therefore, certain key words are italicized to remind us of the importance to reflect on behaviors over this past year and how our actions positively or negatively affect others.

Next up was Public Health Policy Educator, Dr. Stephen Ziegler.  He warned, “be careful what you ask for”, with specific attention to public pressure, media, politics, and resultant government intervention for better or for worse. He spoke on historical intended and unintended consequences of regulation and law from the past and how we have learned from these interventions.  He spoke about the positive and negative impact of the 1906 Pure Food and Drug Act, the effect of initiating triplicate prescriptions for prescribing of Schedule II drugs, and Washington state’s most recent 120 mg Morphine Equivalent Dose (MEQ)/day dosage trigger that requires consultation with a pain specialist. He outlined potential pitfalls of accepting a PROP Brochure before development of clinical guidelines.

Epidemiologist and Public Health Expert, Nabarun Dasgupta explained the available data and helped us to determine what it all means.  He reviewed studies on overdose risk from prescription opioids.  He discussed the 2010 opioid prescribing and overdose characteristics from the North Carolina experience, various dose-dependent overdose risk from opioid analgesics, and contribution of benzodiazepines to opioid toxicity which has not been stratified in studies that solely blame opioids as the causative agents.  Additionally, he highlighted data on overdose risk from extended release vs immediate release opioid analgesics.

Dr. Fudin (yours truly), gave a brief overview on the initial citizen’s petition filed by PROP on July 25, 2012, the immediate subsequent formation of PROMPT and their rebuttal to the FDA, and the media blitz to follow.  He noted that while patients are by far the most affected by all of the policies and outcomes, they have clearly had the smallest voice.  He shared a blog in which approximately 100 seemingly legitimate chronic opioid noncancer patients voiced their concerns about the PROP petition, more specifically how their detailed heartfelt stories have largely gone unnoticed. 

Personally, I learned after the program that many of the signatories on the original PROP petition are not in fact members of PROP and that some are in disagreement with the direction PROP has taken.  It is curious to me then why anybody would sign such a petition on the PROP letterhead without knowing this in advance.

Anesthesiologist and Pain Specialist Dr. Jane Ballantyne followed with a nicely packaged careful overview of the available data.  She reviewed the observational and trial evidence for long term use of opioids for noncancer pain in terms of efficacy and safety outcomes.  She talked about the randomized controlled trials(RCT) with so-called “strong” opioids (morphine) and “weak” opioids (tramadol).  Her review of the RCT short duration efficacy studies from various trials indicated that, compared to placebo, opioids significantly decrease nociceptive and neuropathic pain.  Specifically, her slide detailed that the efficacy of opioids in nociceptive and neuropathic pain is similar; the length of treatment was only up to 8 months; doses were moderate (up to 180 mg/day morphine); no conclusion on tolerance and addiction (patients at risk of addiction excluded); and no systematic assessment of function.  She ended by asking three unanswered questions…

Does the analgesia last?

Does the treatment improve function and quality of life?

What is the risk of addiction?

Surely, we can all agree that better studies are needed to satisfy the unanswered questions.  All of these unanswered questions are high on the radar screen for both PROP and PROMPT and they are important issues for sure. 

Neurologist and Pain Specialist Dr. Charles Argoff presented several cases to illustrate the importance of a “clinical reality check”.  He spoke on rational polypharmacy and the multimodal therapeutic strategies that need consideration based on the individuality of each patient.  He showed obvious flaws associated with previous data drawn from gabapentin and antidepressants and likened this to some dilemmas that stand before us with opioids.  Although he presented much more, perhaps the most succinct but intense messages from his slides were that “The dichotomy of ‘pro-opioid’ and ‘anti-opioid’ is false, and does not serve healthcare professionals, patients, or society well; ethical healthcare providers are ‘pro-health’ and make treatment decisions within that context, and clinicians must learn how to select patients for all pain management therapies when indicated; and manage patients on pain management therapies as safely and effectively as possible.

Dr. Ballantyne was up again and spoke on why dose matters, and what the epidemiological data have revealed about high doses.  Specifically she outlined that higher doses are clearly linked to higher death rates, but she did acknowledge that it could in part be due to sicker patients requiring these high doses.  She nicely outlined the difficulty in taking patients off of opioids after 90 days of continuous use if opioid discontinuation was in fact indicated,  She spoke on the inability of patients to return to the workplace as opioid doses increased, but Dr. Argoff showed at least one case in which a carefully selected patient did in fact have positive outcomes including return to work, as is supported (though unconfirmed) by many blog comments available in the link above.  He also showed cases in support of Ballantyne’s presentation that chronic opioids are risky even in the well-intentioned patient and when prescribed by a careful clinician.  Dr. Ballantyne gave several examples how certain authorities set the daily MEQ limit at 50mg, some at 100mg, 120mg, and others up to 180mg.

The dosage equivalent issues were countered by Dr. Fudin who presented data from a recent study showing that opioid conversion calculators vary in MEQs from -55% up to +242%, the highest disparity being for fentanyl and methadone. In fact, he showed that when converting a fentanyl 75mcg/hour patch to a daily MEQ, there was a (+/-)132mg difference for just one standard deviation using online calculators that mathematically are matched against commonly utilized opioid equivalency charts.  This 264mg total difference is more than twice the 100mg maximum daily morphine equivalent proposed by PROP.   This was topped off with a statement that even if we could agree on a universal equivalent (which is not possible due to several patient variables), consideration for drug interactions arising from metabolism and oral absorption may also contribute to what constitutes an acceptable MEQ for an individual patient.

For all the planning, discussion, and bantering that occurred over the past year, the forum was quite a success.  But, this week it was written and now it is sealed.  After careful self-reflection, it seems that the views of PROP and PROMPT perhaps have more similarities than differences.   It is the approach to solving these issues that has resulted in extensive time, energy, and sacrifice.  But looking ahead to next year, it seems that both sides and attendees are now prepared for a HEATED debate on how to best resolve the issues moving forward.   

 

7 thoughts on “The Great Opioid Divide: Written and Sealed

  1. I would like to, I NEED to actually, just use a platform like this one, where intelligent professionals will hopefully actually read what everyday citizens are really encountering….unintended consequences (hope they are unintended).

    In a previous post, while I admit a bit off topic, I was trying to share how the current pharmacy/patient issues, are having a far reaching trickle down effect. This month for example, my husband had to take Monday off, as I had my monthly appt with pain mgmt Dr., and I would have been home on time to pick up my children from school, if I didn’t have to do the “Pharmacy Crawl”.

    After quite a few different pharmacies, I heard lots of excuses etc.. However, a new one, for me at least, was attempting to use compounding pharmacies, at the recommendation of the Dr office, I was told the following: “We only get a small allotment of these medications, and when those are gone (our allotment), we can order the ingredients to compound the medication, HOWEVER, because you have insurance, we cannot fill for you, as we have to pay so much more for these compound ingredients, we lose money if we go through insurance. And no, you can’t pay cash if you have insurance, because, well that, that is illegal.” …..I didn’t get home until after three, so of course, my husband had to take entire day off.
    Day two, Tuesday. Found a Pharmacy, but would only agree to fill my medication, if I transferred not only all of my prescriptions, but every single family member. My husband lost another hour or two, tracking down his prescriptions, which of course, had no refills. The pharmscists said unless I had two more additional prescriptions, he would not order my prescriptions (after of course he has them, kept them, as when I get all of my family medications transferred, he will order them, and no I normally would never leave them, but they were not doing me any good waking around with them)

    So for day three, Wednesday, my husband is taking off work again, to go to an actual Dr appt, to get his inhaler type medications prescriptions. I can only hope this will satisfy the pharmacist holding my prescriptions hostage until Thursday.

    To sum up…because I have insurance, many pharmacies will not take me as a customer, sure, because they get more from cash paying”clients” (sounds a lot like legalized drug dealing, and no suggestions please how I should file a complaint, lol I don’t have that much time). I have to go to a pharmacy 30 minutes away from my house, that does not have ideal weekend hours for when my children,or I, get sick and need an antibiotic, as I am basically agreeing to have ALL my current and future prescriptions filled only st this pharmacy, if I want to have my pain medications filled (two actual pain medications, out of six, plus two additional non pain medications). My husband is missing additional time from work, when those days are really needed for him, as he is human and does get sick, and he already has to cover for me on days when I am physically unable to adequately function as a parent, which, btw, as each month goes by with less and less medications, those days are happening way more often.

    I appreciate the opportunity to share this snapshot of actual reality for many people like myself. I really want to believe that many that are allowing this pharmacy shortage (yes, I know, we keep hearing that,
    there is no shortage, or the fear that pharmscists are now experiencing, every time a DEA agent stops by) , yes I want to believe that these were NOT THE INTENDED CONSEQUENCES, however, in reality, this is exactly what is happening. Thank you again for all your efforts Dr. Fudin, and your colleagues.

  2. Applying for and being approved for Social Security Disability was one of the toughest decisions i have ever had to make. I loved my job in the Automotive and Retail industry! My body, not so much. It took a toll on me. I have a form of osteoarthritis that causes bone spurs all over my body. My neck has deteriorated to the point that I can HEAR my bones grinding together when I turn my head. There is no way I can even function without these meds. I get up in the morning early because I am in pain. I take my long acting pain medicine that is supposed to last 12 hours, but obviously does not because I am up early, LESS than 12 hours since my last dose. I take a Goody’s powder to get rid of SOME of the stiffness. If I am still hurting in an hour, I take an immediate release medicine to bring my pain down to a level that I can tolerate. So, within about an hour of getting out of bed I have taken three medicines that are supposed to relieve pain. Some days I am in so much pain ALL day that I am unable to do much of anything physical. Some WEEKS I have flares from fibromyalgia and I am unable to go without taking the immediate release medicine through out the day. On those days, my pain level is too high to be able to even walk down my stairs to check the mail. Try to imagine being in a roll over accident where you are thrown around and bruised all over. That’s what my body feels like. One GIANT bruise! Now, without the pain medicine, I would feel like that every single day with no relief. Does my medicine help? Yes! Absolutely! Do I get high? NO! Absolutely NOT! Could I be functional without these meds? NO WAY!

    I am terrified that PROP will become law and myself and many other pain patients will have no where to turn. TY Dr. Fudin for all you do! Please, don’t ever quit!

  3. As we live our lives it appears we have anarchy and chaos happening all around us. Then non-related events take place clashing in to one another. Situations like that of PROP’s proposal to the FDA happen and we think to our self what’s going on here ,why would a doctor with such credentials
    come up with such a Citizens Petition then present it to the FDA with signatures of well known doctors.

    Then a compassionate doctor named Jeffery Fudin comes along and puts things in perspective and things seem to come together like a finely crafted novel.
    By Dr. Fudin forming PROMPT and his rebuttal to the FDA about PROP’s Petition, this gave people that suffer from Chronic pain a voice, and it put things in perspective.
    It seems things have begun to fall in to place for all that suffer from chronic pain.

    This is not about an assault on PROP but coming to a conclusion about the ongoing debate on the Long – Term Opioid prescribing for Chronic NonCancer pain.
    Our voices have been heard and we that suffer from chronic pain will get the treatment we need so badly. Hopefully we have turned a corner to this debate about how opioids should be prescribed and its time we come to a conclusion so chronic pain sufferers of America no longer have to suffer. With “Prescription Monitoring Programs” in place this will help and proper education and careful prescribing of opioid medications.

    Best Regards,
    Mark S Barletta

  4. As a pain patient, I can only echo what many other pain patients, chronic pain patients, are saying, and that is that our voices are indeed not being heard or considered, leavingus with the conclusion that we no longer have a legitimate place in society (of course, having advocates on our side that society does listen to, does, at times, gives us a glimmer of hope for the future).

    It is very confusing, at least for me, especially lately, as I am being squeezed out of my role in life. First, I had a college degree, worked very hard for many years and had a very good career and life. Then, I had children (adopted one only to find out I was also having one, double blessing). Ah, so I was a contributing member of society, a wife, a mother, home owner, etc. Then, one by one, I began to lose each of those identities.

    Due to bone infections and resulting nerve damage etc., I found myself in constant pain. After a couple years, it became evident that I wouldn’t be able to work. But hey, still had my role as wife and mother, then, this last year has really made me question how I could even consider myself a wife or mother, as the media hysteria and the Dr.s and pharmscists suddenly were too afraid to adequately treat patients like me, my quality of life has quickly diminished. I no longer have a role as a wife, since I am under treated, many of my days and nights are spent alone in big bed. I am too afraid to climb the stairs to say goodnight to my children (additional back issues etc and balance issues, I end up paying physically dearly when I attempt), I have been cut back so drastically on my medication, that I, at age of 42, had to use a wheelchair the last time I tried to do a family outing, and now I find myself more cut off from a society, including my own family.

    Perhaps this was the intended agenda after all, to just get rid of the perceived drain on our society. If only they knew, they are really causing additional issues for our society. My husband is missing more and more work, which could lead to him losing his job, and then us losing our house etc etc. These are real people with a real place in their own little community, but it seems like that is not a consideration at all.

  5. Maimonides also said “Teach thy tongue to say ‘I do not know,’ and thou shalt progress.”
    There is much we do not know that we need to know in order to provide safer and more effective relief from chronic pain. Dr. Fudin has performed a great public service by creating a forum to reveal the many facets of the known and unknown pertaining to chronic opioid therapy. Meanwhile, as “the great opioid debate” rages on, the voices of millions of people living with debilitating pain continue to go unheard, and lack of access to comprehensive pain care is the rule. And physicians, NPs and PAs on the front lines who are responsible for the care of these patients, increasingly have much to fear when prescribing due to the activation of payday attorneys and politicians by PROPs publically-voiced spurious allegations and personal attacks on legitimate practices and practitioners—voiced with a certainty that defies the wisdom proffered by Maimonides. This chum, that has been so carelessly strewn in the water for and abetted by those in search of a financial bonanza, political hay or frenzied media attention, is impeding much-needed scientific and social progress by creating such distraction in the field of pain medicine that little else can emerge.

    1. Dr. Fine, Thank you for that wise and insightful soliloquy. I couldn’t have said it better. I know you’ll keep up your patient advocacy efforts and visions for future successful pain treatments, and much needed education.

  6. I was forced to retire from a job that I loved. Due to pain in my knee. Working construction was no longer something I could do. May not sound like the end of the world for most people but for me it was. Now after working for over 50 years I was sitting at home and hating every minute of it. Not only could I not work I couldn’t do anything but sit on the couch. The pain kept me up most all night and I couldn’t be on my feet for more then a half hour before the pain was to great. I had the knee replaced but it never worked right and I was told by 3 top knee guys that doing another replacement would do little to no good at all. Thanks to a pain management doctor I now can enjoy what time I have left with my wife of 50 years. I can go places with my grandchildren to the beach with my wife life is good again. All I can say is god bless the pain management doctors for giving me a second chance at life. Thanks Terry

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