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.