Monday, July 11, 2022

Celebrating Hospice and Palliative Medicine as the Fifth Largest Medical Subspecialty

by Christian Sinclair (@ctsinclair)

We have entered a new age! Spread the word! Hospice and palliative medicine (HPM) is the fifth largest medical subspecialty!

You may have sensed we have been climbing the ranks, but I bet you are still surprised. A close look at the fellowship match data from Dec 2021, shows that HPM has the fifth highest number of matched applicants, behind the big 4: Cardiovascular, Pulmonary and Critical Care, Hematology and Oncology, and Gastroenterology.

When I share this good news with HPM colleagues, few put us anywhere near fifth. I did an informal poll on Twitter and less than half of respondents ranked HPM in the top 10. Of those that did rank HPM, the average rank was 7. Clearly, we are not telling our own story very well.

There are many possible reasons to feel skeptical, but yes, HPM is the fifth largest medical subspecialty! Yet, it still may not feel like that...why might that be? In general, I find HPM clinicians to be a humble, cordial bunch. We may be more introverted. We are not ones to generally boast about our accomplishments as a field. Most of that attention is often dedicated to some new technology or medicine anyway.

Also, maybe we percieve oursleves to be a smaller specialty because access to HPM physicians is still highly variable. Centered in metro areas and more likely to be found wandering the halls of academia, there may be local, regional or organizational reasons why HPM has a smaller footprint in one place, while being a driving force in another. A message can be muddled when telling a large audience to access HPM physicians yet there are none in their area.

Additionally, we are still quite a young specialty, with the birth of HPM as an official specialty being announced in 2005, and getting started in 2008. We have just entered our teenage years. Maybe it is OK to think about ourselves for a bit, and test the boundaries of our newfound confidence like any respectable teenager.

Lastly, many are working in health care organizations which still treat palliative medicine and hospice physicians as “nice to have” instead of “essential.” It is hard to feel like you are part of a larger group when there are not many colleagues around you. The teams we work with may still feel empty without all the key disciplines collaborating. A HPM physician is a good start, but when there are no resources, no infrastructure and not enough people to get the work done, HPM may be limited to being little more than a glossy brochure.

So why do we need to talk about this? Because this is a great opportunity to increase visibility which can help in a variety of ways. The message is simple, HPM is the fifth largest medical subspecialty! We are right behind cardiologists, oncologists, critical care and GI and this should be something (when shared) helps to cement our stature. When you are number five, we should not settle for being relegated to choosing ‘other’ on a list of medical subspecialties. If rheumatology is on there, so are we. If geriatrics is on there, so are we. If infectious disease is on there, so are we.

Sharing this message increases our visibility at our own organizations. We should be including this in our presentations on Hospice and Palliative Medicine 101, or frankly anytime we are asked to speak to outside audiences. We need to share this on social media and in conversations with our colleagues, friends and family. People should want to understand what hospice and palliative medicine doctors do, especially when HPM is the fifth largest medical subspecialty.

We are currently in fellowship application season, so this is a message to share when people come to your program. This increased national visibility will also help bring more people to our field with fresh ideas, diverse backgrounds, and new skills. We have important areas to grow with HPM physicians playing an important part including outpatient and community care, hospice care, pediatrics, and research. Right now, we are not filling all of our fellowship slots (85% filled) and we have a looming HPM physician shortage. What a great time to be popular and get the word out to pre-med students, med students and residents of all primary specialties to put HPM onto their short list. It will be hard to act surprised when learners declare an interest in palliative care, because after all, HPM is the fifth largest medical subspecialty.

I am still surprised this Tweet happened as recently as 2018!



I do not expect that to happen in the future. The more we share the growth of our field, that we are here, that we have numbers, that we are strong, and that we will make an impact, then we can reserve OUR seat at the table to make the important decisions shaping the future of health care. I hope you are thinking of the first person you need to tell that HPM is the fifth largest medical subspecialty. Let’s do it!

Original data here from NRMP. Summary of data for this post below.





For more Pallimed posts by Dr. Sinclair click here.
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For more Pallimed posts about hospice and palliative medince fellowship click here.


Christian Sinclair, MD, FAAHPM is a palliative care physician at the University of Kansas Health System, editor-in-chief of Pallimed, and trying to keep up a resolution to write more about palliative care in 2022.

Monday, July 11, 2022 by Christian Sinclair ·

Friday, May 13, 2022

The Peril and Privilege of Exploration: A Review of Subnautica

by Matt Tyler (@PalliDad)

In the survival game Subnautica, you play the role of a space voyager who has crash landed on an aquatic alien planet. You must find a way to escape while navigating the planet’s beautiful but dangerous flora and fauna. Exploration makes the core of Subnautica, and because I am a palliative care doctor, I couldn’t help but draw a parallel to serious illness conversations. Whether exploring shipwrecks and underwater caverns or the emotions and stories of patients, both require curiosity, methodical skill development, and respect for boundaries.

Any explorer must first and foremost be curious, even in the face of danger. You won’t make progress in Subnautica if you don’t get close to some scary sea monsters. The same is true for serious illness conversations, maintaining curiosity is essential even when encountering a strong emotion like anger. Rather than presuming an angry patient misunderstands the situation, a curious mind wonders about the origins of that anger and the suffering that may be beneath the surface. The empathy that flows from this curiosity can lead to new levels of understanding.

And yet, curiosity alone can only take you so far. At the beginning of Subnautica, your basic equipment will only let you explore a short distance below sea level. To discover the planet’s deepest secrets, you must gradually accumulate the resources necessary to upgrade your diving gear. Likewise, we need more than curiosity to explore the complexities of a patient’s physical, emotional, spiritual, social, and cultural needs in the face of serious illness. It takes time to develop the skillset needed to facilitate these conversations, ideally with observation and feedback from experts.

Even with the most advanced exploration equipment, there are depths in Subnautica that remain out of reach. There are no physical barriers to show that you’ve reached the world’s edge - that understanding only comes with your fully realized abilities. Similarly, seasoned communicators appreciate that although there are parts of a patient’s story that can be explored with advanced skills, there are always boundaries that must be respected. Though it requires a certain level of expertise to see these invisible walls, noticing their presence is vital for creating a patient-centered care plan.

Ultimately, survival in Subnautica depends not on rebuilding the world to suit your specific needs, but on learning how to work with the world on which you’ve crash landed. Building a relationship with our patients requires the same approach. If we are willing to dive into our patient’s world to understand and support what matters most to them, who knows what beauty can be discovered?

Subnautica is available to play on PC (Steam), macOS, PlayStation 5, Xbox and Nintendo Switch systems.

This post has a companion piece video hosted by Digital Doc Games (embedded below). Check out the Digital Doc Games YouTube channel hosted by Dr. Amiad Fredman for videos on how video games have a huge power to have a positive impact on people's lives.





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For more Pallimed posts by Dr. Tyler click here.



Matt Tyler is a palliative care doctor in Chicago. If he's not watching Cocomelon with his daughters, he is probably playing video games.

Friday, May 13, 2022 by Pallimed Editor ·

Monday, May 2, 2022

Simplifying Opioid Conversions

by Drew Rosielle (@drosielle)

A Satirical Monologue in One Act:

“Ok, 3rd year resident, let’s talk about rotating opioids. What do I mean by ‘rotating’ opioids? It’s just therapeutically switching one opioid with another. It’s um, like, a turnstile, I guess? Anyway--first let’s look at this equianalgesic table. Do you know what equianalgesia means? No? It is the concept that different opioids have the same analgesic power but at different milligram doses due to different potencies. That is, the idea that, say, 50 mg of oral morphine has the same analgesic power as 10 mg of hydromorphone. So 50 mg of oral morphine is equivalent to 10 mg of oral hydromorphone.

"Ok, let’s look at this table, every entry on this grid is equianalgesic, meaning that the 30 mg here of oral morphine has the same analgesic power as the 1.5 mg of IV hydromorphone. So, let’s say we have a patient on 100 mg oral morphine. How much hydromorphone is that “equivalent” to? Ok, so what we have to do is set up a cross multiplication problem…here’s how you do that.

[We’ll skip the painful talk-through of the cross multiplication.]

"Ok, so it looks like the answer is 5 mg of hydromorphone IV. Now we have to adjust that dose for incomplete cross-tolerance. Do you know what that is? No? Ok, so incomplete-cross tolerance is the idea that our patient on 100 mg of morphine is somewhat tolerant to the morphine. They are therefore also presumably somewhat tolerant to any other opioid agonist like hydromorphone. The problem is that the tolerance they have to morphine may not fully apply to the tolerance they have to the hydromorphone—the morphine tolerance “incompletely” transfers so to speak to the patient’s hydromorphone tolerance. So, what that means is that even though this table says 100 mg of PO morphine is equal to 5 mg IV hydromorphone, for safety’s sake we need to reduce that 5 mg somewhat to determine what we actually put the patient on. That’s what we mean by reducing for incomplete cross-tolerance.

"If you have 5 minutes, it’s actually an interesting story, because no one is really sure that ‘incomplete cross-tolerance’ is even physiologically a phenomenon, like on the cellular level, our field just calls it that because that’s what it’s always been called. In fact, the idea of ‘incomplete cross-tolerance’ only makes sense if you think there actually is a firm “equianaglesic” potency relationship between morphine and hydromorphone that applies to most patients. In fact, no one actually believes that and the broad consensus is that there is a pretty significant range of ‘equianalgesia’ between any 2 opioids in different patients. I.e., in one patient, 100 mg of oral morphine may end up providing equal analgesia to 12 mg IV hydromorphone, in another patient, 4 mg of IV hydromorphone, etc. It’s a little bit of a crap-shoot.

"Actually, it’s probably far worse even with fentanyl, we’re talking about a far, far wider range of individual responses, and don’t even get me started talking about methadone and buprenorphine [self-knowing chuckle here]!

"So, back to incomplete cross-tolerance. If you’re going to argue that it would just be easier to say ‘dose reductions due to safety’ or ‘dose reductions due to individual variability in responding to opioids’, you’d be right. That’s much easier to understand, and probably more accurate, but maybe it makes us feel like we’re the keepers on secret knowledge to say incomplete cross-tolerance? Who knows?

"Regardless, this is where it gets really interesting, because to properly account for ‘incomplete cross-tolerance’ we have to decide how much less opioid we need to put someone on after we do the initial calculation. Yes, there are 2 calculations: the equianalgesic one, then a 2nd incomplete cross-tolerance one in which we reduce the first amount by a further amount, most people recommend 25-50%.

"How do you choose how much you actually dose reduce? Well, there’s about 10 patient factors you need to balance when making that decision. Yes, I said 10, but don’t worry, if you do this for a couple years it’ll become second nature to you [self-knowing chuckle]!

"Ok, so let’s talk about these 10 patient factors….”

[End]

Dear friends and colleagues, I think we can all do better than this, and here is my current thinking as to a better approach.

In my last post I outlined why I think equianalgesic tables (EATs) are broken and proposed we collectively move instead to using Conversion Tables (CTs) when teaching others how to switch opioids. Briefly, this is because CTs engender much simpler and clearer math; and we can easily adjust the conversion factors in CTs based on emerging data, without having to rejigger every ‘equianalgesic’ relationship which EATs force us to do. My offer from the last blog post still stands: it would be ideal if there could be a consensus process to generate a consensus CT that our professional community can broadly adopt. While I like the CT I made, I don’t think any one person should be setting the conversion ratios alone, even if it is standing on the shoulders of giants! I’m not an investigator but am willing to lend any support I can to this. It is also possible the best option is for organized medicine to lead this, and I’ve been chatting with some folks about this a little already. I’m not sure where it will lead, nor if AAHPM has any appetite for that, we’ll see.

Regardless, I’ve been thinking and talking with others a lot about the entire enterprise of how we teach and talk about opioid switching and I have a lot of ideas that go beyond CTs for potential ways we can improve our approach to this. This post is simply to capture those ideas, none of which I’m claiming are independently mine.

1) We should never utter the phrase “incomplete cross-tolerance” again.

I hope this is not controversial, I’ve yet to meet anyone in the “Incomplete Cross-Tolerance: What a Super Helpful Concept!” camp, but its use continues to pervade discussions of opioid switching. My fundamental objections to incomplete cross-tolerance: it is a concept that requires an entire paragraph of explanation (!!) to someone unfamiliar with it, plus it may not even be a ‘real’ thing, plus there are readily available, broadly understood, completely accurate alternatives to it (e.g., dose reductions for safety, dose reductions due to individual variability, etc.). While the monologue that started this post is satire, I’m sure I’ve uttered every phrase in it for real at one point or the other in the past 20 years. I know I am not alone.

2) We should talk about ‘methods for safe opioid switching’ and not equianalgesia. Equianalgesia is unnecessarily jargony and I don’t think it even exists on the population level.

Incomplete cross-tolerance only makes sense if we think equianalgesia itself is a firm and helpful concept. If you believe that we can announce, without qualification, that 20 mg of IV hydromorphone is ‘equianalgesic’ to 100 mg of oral morphine then maybe it makes sense to talk about incomplete cross-tolerance. But I don’t know of anyone who thinks that “100 mg of oral morphine is equivalent to 20 mg of IV hydromorphone” in any sort of widely generalizable, arbitrary way. I think all of us operating in this realm may acknowledge that across 100 patients maybe the averages end up close to 100:20, but who cares? Honestly, that factoid is a DISTRACTION because the way EAT switching has currently been set up has encouraged us to first focus on this fake-and-based-in-less-science-than-we’d-want notion of equianalgesia, then prompted us to do this secondary work-around-caused-only-by-the-fact-that-we-set-a-ratio-in-the-first place. Why do it this way? Why not just switch at a ratio that works most of the time, instead of nearly none of the time?

The clinical task we are faced with is not an abstract exercise in the variable potencies of different opioid molecules averaged across the human population, instead it’s a practical task of How do I safely switch this patient’s opioids? Safely means two things here: that the patient does not have significant sedation from the switch nor a major worsening of their pain. I do think what I’m arguing here is more than semantics—that going from equianalgesia to ‘methods of safe switching’ is not just me renaming it. It is a significant conceptual frame shift in this critical and common.

Using a concept like ‘equianalgesia’ promotes this idea that there’s a “right answer” to the question of “If I’m switching someone from 100 mg of morphine in a day to IV hydromorphone how much hydromorphone do I prescribe?”

My proposal is there isn’t a right answer. It is not a helpful goal or concept and we need to move onto the more salient task of switching safely. That framework focuses us on a practical clinical task. From talking to colleagues, many of us who prescribe methadone and buprenorphine long ago moved on from any idea that it was our task to somehow divine the ‘equianalgesic’ dose of methadone from another opioid. Instead, we have a protocol to make the switch, the protocol works (‘is safe’), all is well with the world. My proposal here is that this is how we conceptualize all opioid conversions.

3) We must start emphasizing that the absolute dose of opioids involved matters for safe switching.

Stepping back from the finer points of what conversion ratios we should be using for opioids—honestly, if what you’re talking about is doses in the range, say, of 40 mg of oral morphine, I don’t really think it matters what ratios you use to switch. Frankly, it probably doesn’t matter much if you reduce further for safety or not.

Consider someone is on 40 mg a day of morphine PO. You want to put them on IV hydromorphone:

-- Classic EAT: divide by 20 to get 2 mg of IV hydromorphone

-- DOC2 Table: divide by 12.5 to get 3.2 mg of IV hydromorphone

If you reduce further for safety, presumably you’ll still get an answer about 1.2 mg apart between the 2 tables. Honestly, I don’t think the difference there is much of a safety concern. Both are fine. No opioid- tolerant patient became sedated or had a pain crisis because of a difference of 1.2 mg of IV hydromorphone over 24 hours; of course, the ‘fine-tuning’ might be a bit different, but as long as a patient had close follow-up the analgesic outcomes would be about the same too.

But what if the patient was on 400 mg a day of oral morphine? Personally, I would not be so cavalier about saying there is no relevant difference between 20 and 32 mg of IV hydromorphone in a day.

Yet, if you read pretty much all the opioid conversion stuff out there, they all treat these opioid switching ratios as fixed across all ranges of opioid doses. They suggest the same approach for 400 mg of morphine as 40 mg of morphine. To me, this is shocking, and profoundly unsafe. I’ve never met a single person who treats opioid switching ratios as linear across all opioid doses, meaning they would be more ‘conservative’ in their switching for someone going from 400 mg of morphine than 40 mg. I believe I am merely naming here a clinical practice which is already widespread! Yet, for the last twenty years of journal articles, books, national presentations, and local presentations that I’m aware of, this is not splattered in flashing neon ALL CAPS at the top of every table. It is not a core part of our basic nor specialty teaching on this topic. I genuinely don’t understand it.

Fundamentally, I’m arguing that we’ve heaped HUGE amounts of attention on the complex subtleties and nuances of reducing for safety when it comes to opioid switching, and virtually no attention to the nuances of switching at higher dose ranges. I think we got this wrong.

All this leads me to a few practical proposals:

1) “We”* stop using EATs and instead use simple “going from X to Y” conversion tables (see this post for more details).

2) We frame this practice as methods of ‘safe switching’ and do away with ‘equianalgesia’ (at least as a core concept in teaching others about opioid switching) and ‘incomplete cross-tolerance’ (that we can discard completely).

3) We promulgate a conversion table without need for additional dose reductions in most patient scenarios. I appreciate this is in some ways the most radical thing I’m proposing here, and certainly it is the one I’m most tentative about. But I suspect that a lot of our need for “reducing for incomplete cross-tolerance” has come from the fact that in order for any of our EATs to make sense they’ve needed to have on them conversion ratios that are dangerously aggressive. E.g., the for the Classic EAT I would divide the PO morphine dose by 20 to get the IV hydromorphone dose and, truth be told, it would be rare I would dose reduce beyond that: it was a good safe ratio much of the time in my experience. However, the reverse conversion, multiplying the IV hydromorphone dose by 20 to get the PO morphine dose, I regularly, heavily dose reduced (often by 50%). My argument is that to a large extent our need to create that 2nd step of dose-reduction really comes from the fact that we locked ourselves into aggressive conversion ratios with EATs and if we had just a simple “Going from X to Y” conversion table with pre-set ‘safe’/conversative ratios, we can side step this incredibly complex beast we’ve created (the need to reduce for safety / “incomplete cross tolerance”).

How would we do this: my idea is that we create a conversion table which folks broadly agree they’d be comfortable handing to a first month medical intern and telling them: “Young doctor, within these parameters, just use this.” If this idea freaks you out, remember for decades we’ve handed them inscrutable equianalgesic tables with even more inscrutable and hand-waving suggestions about reducing for incomplete cross-tolerance and expected them to know what to do. My hypothesis here is that the method I’m proposing is safer and requires far less needless work for our generalist colleagues.

As an example, we’d create a conversion table for a hypothetical 70-year-old with an eGFR of 50 and mild frailty—something like that. The idea being that most of the conversions happening out there are for patients like that or more physiologically robust, so the table would be built-in safety for a broad range of patients. I think it could be close to my draft Conversion table (Dropbox, Google Drive), but some of the conversions would be more conservative for sure.

The table would need to be explicitly labeled with the dose limits (E.g., this is for patients on 100 mg or less a day of oral morphine, 20 mg a day or less of IV hydromorphone, etc. This would avoid unnecessary calculations of oral morphine equivalents (OMED, OMDD, OMD, or any variation on those abbreviations). What those ‘dose caps’ are would require, I imagine, vigorous discussion, and I don’t strongly believe the, e.g., 100 mg a day morphine cap is actually the right one.

The table and associated teaching strongly emphasize the structure of care and close follow up is what’s most important for switching opioids safely. Don’t switch and walk away, switch and follow up!

Importantly, I’m proposing this is a conversion table for ‘generalists’ who switch opioids. I think the role of palliative and pain specialists is to have a deep knowledge of all this, including the history of opioid switching, and the nuances of dose reductions for safety, etc. All our fellows (and all our colleagues) should read Demystifying Opioid Conversions 2 Ed (aka DOC2) if they haven’t already! However, that book is not for generalists, they aren’t reading it and we can’t expect them to read it. To be clear—I’m not suggesting we jettison that book or the accumulated knowledge of opioids switching, I’m more proposing there are simpler and arguably a little safer way to teach our generalist colleagues about this, keeping in mind that to date we’ve made it so difficult for them most of them are using online calculators of various levels of reliability!

This is just a proposal which has come out of one person’s brain. I very much believe that ideally this is best decided by consensus and committee (in the absence of good clinical data for which there are zero). So, it is meant as a starting point for discussion. Ideally, I’m hoping others will join me and I am talking with CAPC about this and plan on with AAHPM too. I think the new data from MD Anderson which lead to the change in the DOC2 Table are a great opportunity for us as a field to collectively look at all this and try to do something that is far simpler, and at least a little safer. If you’re interested, let me know!

(This post was updated May 3, 2022 to correct an error in the opioid calculations!)

For more Pallimed posts about opioids.
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Drew Rosielle, MD is a palliative care physician at the University of Minnesota M Health Fairview in Minneapolis. He founded Pallimed in 2005. You can occasionally find him on Twitter at @drosielle.



Monday, May 2, 2022 by Drew Rosielle MD ·

Monday, March 21, 2022

Opioid Equianalgesic Tables are Broken

by Drew Rosielle (@drosielle)

I am proposing we do away with equianalgesic table (EAT) as a tool to inform clinical decisions about opioid rotations/conversions. Fundamentally, EATs create too many problems, and there are simpler and safer ways to teach clinicians how to convert between different opioids.

Part 1: New Data Can't Fix the EAT

A couple HPM fellows every year ask me which table do I prefer to use—the old EAT or the new one? By the old one, they refer to the table most of us used or were at least deeply familiar with for the last 10-20 years. By the new one, they mean the one created by Dr. Mary Lynn McPherson, PharmD in her landmark book Demystifying Opioid Conversions, 2nd Ed. If you haven’t read the book, please do, it’s really one of the best things ever written about opioid conversions. My disagreement with the book, which is admittedly a big one, is that the book promulgates the use of EATs, and my entire argument today is really in some ways inspired by the conversations I’ve had with my fellows and others as we grapple with the new EAT in her book. (From here, I’ll refer to the tables as ‘Classic’ and ‘DOC2’.)

Fundamentally, my argument is EATs themselves are intrinsically flawed: they ‘force errors’ in a way that’s entirely unnecessary and avoidable if one just doesn’t use EATs as clinical decision aides (I’ll elaborate on that statement below). Dr. McPherson’s curating and teaching new, reliable clinical data is critically important, yet better data in a flawed model like the EAT creates as many problems as it solves. I feel a little awkward putting all this out like this. Dr. McPherson is one of my heroes. The DOC2 EAT crystallized concerns I’d had over the years, and the followinghas come from conversations about EATs prompted by me and my colleagues grappling with a new table. The new DOC2 EAT is clearly better in important ways, but I also think recapitulates all the problems intrinsic to EATs, so much so we collectively should consider doing away with them.

The 2010 table is the Classic EAT, the 2018 table is the DOC2 EAT. You can see it’s changed throughout, but the big changes are the around hydromorphone, with the biggest changechanging the20:1 PO morphine:IV hydromorphone ratio to a 12.5:1 ratio.



The big changes in the DOC2 EAT are based on this study by Dr. Akhila Reddy and colleagues looking at real life data about converting hospitalized cancer patients from IV hydromorphone to PO morphine, PO hydromorphone, or PO oxycodone. Reddy et al found that the average IV HM to other drug ratios were 1:2.5 for oral hydromorphone, 1:11 for oral morphine, and 1:8 for oral oxycodone (meaning in this population, a patient on 10 mg/24 hours of IV HM, on average would end up on 25 mg PO HM / 110 mg PO MS / 80 mg PO oxycodone per 24 hours). Importantly these doses are lower than what the Classic EAT would predict, and for PO morphine and hydromorphone, a lot lower (Classic EAT promotes a 1:5 ratio for IV HM:PO HM; 1:20 ratio for IV HM:PO MS; and 1:10 ratio for IV HM:PO oxycodone)!

To the best of my knowledge, the DOC2 EAT exists largely to better account for these ratios going from IV hydromorphone, considering that Reddy et al is undoubtedly the best/biggest real-patient study looking at this very relevant real-life clinical question. (It also tweaked the IV to PO morphine ratio in a small manner, going from 1:3 to 1:2.5. Probably small enough not to matter for patient care, but enough to make for more challenging math, but that is a small quibble).

I want to observe that I think the Reddy et al study is a landmark study, and I think it provides the best evidence we have of ‘real-world’ “equianalgesia” when going from IV HM to those other opioids. I absolutely think we should all be modeling our clinical practice of opioid conversions on these data as best we can!

The problem is, however, when you try to ‘map’ these data onto the rigidity of an EAT, in which every ‘relationship’ between opioid doses/routes is fixed and bidirectional, you encounter all sorts of problems, ALL OF WHICH exist due to fact that you are using an equianalgesic table in the first place. What I mean is that all the problems that are introduced by creating a new EAT from this study, merely exist because we, as a professional community, have decided that EATs are the best format for presenting information to guide opioid conversions. The fixed and bidirectional nature of EATs itself creates the problem, and my argument is that all this will go away if we discarded EATs entirely as teaching tools/clinical decision aides for opioid switching.

Let’s look at the IV HM to PO MS ratio in the EATs as an example. In the Classic EAT there is a 1:20 (look at the table: 1.5:30 is a 1:20 ratio). Meaning you’d convert 1 mg of IV hydromorphone to 20 mg of PO morphine, and you’d convert 20 mg of PO morphine to 1 mg of IV HM (before dose-adjusting due to ‘incomplete cross tolerance, patient factors, safety, etc).

Reddy et al gave us good reason to believe that when converting from IV HM to PO MS, that 1:20 is too aggressive: the morphine dose is too high. So, if you change the EAT from 1:20 to 1:12.5 which is what the DOC2 EAT recommends, you get a conversion that’s more in line with current knowledge.

So far, so good! But, now look at what happens when you use the tables to convert from PO MS to IV HM. 100 mg PO morphine in 24 h converts to 5 mg IV HM in 24 h using the Classic EAT ratio of 20. Using the DOC2 EAT ratio of 12.5 you get 8 mg of IV hydromorphone. We’ve all of a sudden made the conversion in the reverse direction far more aggressive than it previously was with the Classic EAT! Is there any data to support being far more aggressive in this direction? No, not that I know of; the data are only about going from IV HM to other opioids, not to IV HM.

So, in making a conversion more conservative/more evidence based in one direction, we’ve made it substantially more aggressive in the opposite direction, and done so without any evidence backing it up.

The same thing happens with IV to PO HM. Reddy et al suggests IV HM going to PO HM is a 1:2.5 ratio which is reflected in the DOC2 EAT (Classic EAT has a 1:5 ratio). However, that makes a user of that table use twice the amount of IV HM when going from PO HM than the Classic EAT suggests. This doubling-of-how-aggressive-we-should-be with that conversion, as far as I can tell, is not based on any data, and I argue it’s no small thing to put out a EAT which encourages doubling the dose of IV hydromorphone compared to prior practice without safety data, but it’s an unavoidable byproduct of the Reddy data being forced into the format of an EAT.

My point here is that using an EAT forces us to do this. There is no way around this in the format of an EAT: the fixed bidirectionality of EATs causes this. So—why do we even use EATs?

The best data we have about going from IV HM to PO oxycodone is that it’s a 1:8 ratio. However, the new DOC2 EAT uses the Classic EAT 1:10 ratio. Why? I’m assuming it’s an effort to keep the DOC2 EAT coherent. Think about what it would look like if you used a 1:8 ratio. In the DOC2 EAT, 2 mg of IV HM would map to 16 mg of PO oxycodone. But that means that 16 mg PO oxycodone would map to 25 mg of PO morphine! What a bleeding mess!

And that’s the point: EATs exist in some sort of fantasy universe in which we have for some reason assumed, based as far as I can tell, on no data whatsoever, that the RATIO of morphine to hydromorphone, has to exist in a fixed and eternal relationship with the relationship between, say, oxycodone and hydromorphone. Based on EATs, if you tweak the relationship between oxycodone and hydromorphone it impacts the potency relationship between morphine and oxycodone! They all are forced to shift together because the whole idea behind an EAT is that every value in every cell of that table is ‘equianalgesic’ with the other values.

Why? I don’t see any data to think this has to be the case, at all. All of this strikes me as an overly simplistic and rationalistic assumption of how incredibly complex things work, that creates all of these issues I’ve been elaborating above when you try to do the right thing, which is what Dr McPherson did when she updated her EAT based on good data! The problem is that the format of the EAT itself undermines any effort to use better data to improve it.

Dear colleagues, we don’t have to keep doing this to ourselves. There is another way, some of you are probably already using different methods anyway, and I’ll propose one in a bit, but first I want to make one more argument against EATs in general: they force people into doing unnecessarily complex math.

Part 2: Complex Math is Complex

EATs encourage people to do unnecessarily complicated math. I’m sure I’m not the only greying palliative clinician who’s realized the last several years that a large number of the fellows and residents I work with don’t actually know how to use an EAT. They instead use opioid conversion smartphone apps or websites. Years ago they didn’t know how to use EATs either for the most part, what’s changed now is that they can avoidlearning how to use them completely due to the software converters. (By the way, every single app/website I’ve looked at base their math on EATs and so have in them all the fixed bidirectional problems I mentioned above).

A few months into the fellowship year when I’m working with fellows and one is using an app I’ll ask them to walk me through an opioid conversion calculation. It’s not uncommon for me to realize that they just can’t do it. These are physicians, these are people who are highly educated and know their way around algebra, but they still avoid doing EAT math because it’s clunky, it’s easily confusing, and legitimately easy to make mistakes. This is because they are taught that the way you use EATs to calculate the dose of the new opioid is this:



Holy smokes we make them do cross multiplication!

I’ve learned that cross multiplication makes some people really uncomfortable. And frankly I don’t blame them—it’s easymake mistakes— it’sto multiply when you should divide, etc. I myself, long before my current thoughts about wanting to discard the clinical application of EATs began to solidify, had just completely stopped using cross multiplication in doing these conversions over a decade ago. I have always looked at the table, calculated a conversion factor, and just used that.

For example, looking at the Classic EAT, it suggests 1.5 mg IV hydromorphone is ‘equipotent’ to 30 mg PO MS. That’s a conversion factor of 20: 1.5 x 20 = 30, right? So if a patient was on 10 mg of IV hydromorphone, I’d just multiply that by 20 to get 200 mg of PO morphine, and go from there (adjust the dose down for patient safety reasons etc). I would’t bother doing cross multiplication at all.

This math is much easier to my brain, and also easier to ‘gut check double check’ your math, because you ‘know’ a morphine dose is 20 times the HM dose. With cross-multiplication, those relationships are less obvious, and so easy to invert, especially for novice users, who don’t have an intuitive sense for instance if PO hydromorphone is more or less potent than, say, IV morphine!

Making people to cross-multiplication was a huge pedagogical error. Thankfully, it’s totally unnecessary.

Part 3: Conversion Tables as a Better Tool (?)

All this adds up to my modest proposal: that we do away with EATs entirely as we teach others how to convert between opioids, and replace them with Conversion Tables, that aren’t really tables, just a condensed clinical decision aide in prompting clinicians with easy math and individualized, conservative conversion recommendations that are specific to each conversion. For instance, the conversion tip for going from IV hydromorphone to PO morphine exists independently of the conversion tip for any other conversion including even a different ratio for converting from PO morphine to IV hydromorphone.

I want to acknowledge that I did not invent this idea. I’ll be honest, I’m not sure where in the depths of my memory it came from, but in some ways it’s such an obvious idea I hope when I post this people will comment with examples of opioid rotation decision tools which use the conversion factor approach instead of an EAT! I’m sure it’s out there. If anything is novel about what I’m writing today, it’s mostly in the call to broadly give up on the EAT as a clinical decision tools, not the novelty of using conversion factor tables.

From all this, I’ve mocked up a Conversion Table (pics below of an abbreviated pocket card sized Table and part of the full, annotated Table, with all my explanations and anxious thoughts about the factors, and links to more detailed (but not ready for clinical implementation-see below) versions: Dropbox, Google Drive).



This is one section of the longer, annotated Table:



Benefits and Caveats of Conversion Tables:

• Every single conversion can have its own ratio, and that ratio can evolve/change over time (due to new data or clinical wisdom) easily, without messing up any of the other conversions. You can change the IV HM to PO morphine conversion without that having ripple effects on every other conversion!
• Along those lines, we can have different ratios going from, e.g., IV HM to PO morphine than when we go from PO morphine to IV HM. My argument is that a key reason to do it this way is safety, mainly because if we as a professional community tighten up one conversion it doesn’t force us to ‘liberalize’ its reverse.
• It prompts easier math. Every conversion is just one multiplication or division problem.
• This is true in my opinion of all opioid conversions, regardless of which table you are using: we should increasingly become more and more cautious in all opioid conversions the higher the doses that are involved. I personally think all conversion tables and EATs should have a huge warning on them that says something like “DO NOT USE THESE RATIOS FOR OPIOID DOSES HIGHER THAN 150 MG OF ORAL MORPHINE EQUIVALENTS—CONSULT AN EXPERT” or something like that. (Feel free to argue with me about the 150 mg figure—I don’t myself know what the limit should be other than that number is something that feels good in my gut but that’s all.) I wrote about this in detail in 2019. The bottom line is that I think we should treat all opioid conversion ratios as non-linear at high doses, like we do with methadone at all doses, and that every single guide to opioid conversions needs to SCREAM this.
• Along those lines, I can imagine someone saying about all this, “Look, does it really matter which table we use because, let’s say we’re going from PO to IV hydromorphone, does it really matter if the final answer is 2 or 4 mg!” I would say I am highly sympathetic to that perspective. Look, the reality is, at lower doses, for the vast majority of our patients, it honestly doesn’t make that much of a difference! But, my argument is, the higher the doses involved, the more this stuff really starts making a difference. I am NOT going to lose sleep over if my fellow puts a patient on 2 vs 4 mg of IV hydromorphone a day. I am going to lose sleep over 20 vs 40 mg of IV hydromorphone a day though! This is why 1) I think whatever we put out there for the non-specialist clinician to use needs to be conservative because clinicians will use these at high doses if we put them out there, and 2) we need to signal/emphasize/warn on EATs or Conversion Tables that they are not to be applied at those higher doses! Honestly, I think that’s an even more critical safety practice than fine-tuning the actual conversion ratios.
• Please look through the draft/mock ups of the conversion tables. I don’t mean these to be implemented in clinical settings currently!! I have spent more time arguing with myself about the actual numbers (conversion factors) I put down on paper in those tables than I have writing this cruelly long blog post (you can see some of my comments about my decisions in the Annotated Tables—I’ll let you know that at one point these included conversions around IV fentanyl and I just gave up it’s such a mess). Part of the debate I have with myself is, from a pedagogical standpoint, just how conservative should these numbers be? Should we automatically make them so conservative that we can say that for the ‘average patient’ you don’t need to dose-reduce further? Should we still even be incorporating ideas of incomplete cross tolerance, which, I probably don’t need to tell you, is an incredibly complex, and nuanced thing we inflict upon others. I.e., we show people these tables, tell them to use them, then say, "Oh by the way once you’ve done that you need to make a highly complicated, patient-specific decision about manipulating the final dose ever further, based on these TEN DIFFERENT FACTORS!" I do wonder if we can do better than that.
• I’m not sure what the right answer is here. Certainly, I’m not the one to be deciding this, either! My dream would be that something like this is workshopped and researched with clinical and pedagogical leaders then tested in some way for safety, and I think the ‘best answers’ as to how conservative these numbers should be would come out of that dream process. What I’ve mocked up are things I’d feel comfortable handing a fellow personally, but I just want to be clear to the world I am not proposing my draft tables as anything more than an example of what a hypothetical conversion table could look like in the future. That’s it.

I’m very curious what people think about this. Who’s already moved away from EATs to conversion tables or something similar? What do people think of my draft Tables? I am not an investigator, but if someone who is, and knows how to lead an investigation into validating something like this (not that EATs themselves were ever validated), please ping me. I’d love to chat. I smell a Delphi study!

Post-script, because I sure someone is going to bring this up, and rightfully so: I’m not arguing that we entirely discard EATs for every single application out there, just the clinical/pedagogical ones. They arguably have a role in research and public health—e.g., the ideas in EATs give us a way to calculate OMEs/MEDDs (24 h oral morphine equivalent dose). I think the idea of the OME has its utility at least in research contexts, and we need some way to calculate it, and sure an EAT is an ok way to do that, although I’ll also point out that the OME has been weaponized in the last several years by those who insist, for example, that an OME of 50 mg is some sort of evidence-based hard limit on safe opioid dosing, and the insidious carceral/cops-in-medicine ‘tool’ that is the NarxCare Score.

For more Pallimed posts about opioids.
For more Pallimed posts by Dr. Rosielle click here.



Drew Rosielle, MD is a palliative care physician at the University of Minnesota & M Health Fairview in Minneapolis. He founded Pallimed in 2005. You can occasionally find him on Twitter at @drosielle.



Monday, March 21, 2022 by Drew Rosielle MD ·

Monday, January 24, 2022

The Annual Assembly and COVID

by Christian Sinclair (@ctsinclair)

Last week, many hospice and palliative care clinicians and advocates received the unfortunate news that the 2022 Annual Assembly of Hospice and Palliative Care (#hapc22) was moving from hybrid (both in person and virtual) to virtual only. The board of directors of AAHPM and HPNA "considered the current strain on health care systems, personnel and their families" when making the decision. And then one week later, many presenters found out their presentations were not going to be in the virtual-only assembly. That is immensely disappointing. I received notice that my talks - on which colleagues and I had spent hours working - were canceled too. I was shocked at first, then mad, a little incredulous, then sad I would not get to share my work with a wider audience. Online, others shared similar emotions about the bad news. It really stinks.

I think it is critical to direct the majority of ire at COVID, which threw us all a curve ball with omicron. Honestly going into October and November, many clinicians I know were beginning to regain that hope and return to normal. The clinic visits were more often in-person (rather than telehealth). We had meetings with small groups in big rooms. All signs pointed to "Yes!" An in-person Annual Assembly in Feb 2022 seemed possible. So when you feel angry, make sure to direct that anger at COVID..

As for mitigation of risk, or different strategies, or communication planning around this issue, it is reasonable to ask for more information from the two organizations, but let's make sure we are asking the right questions and the right people. The strategy is the responsibility of the board of an organization. The staff of an organization is responsible for executing on the plan set out by the board. Boards need to make very difficult decisions. From personal experience, those conversations before the decision can also be quite challenging. I think the business meetings for both HPNA and AAHPM should be high on your priority list if you want to hear more about how we got here. If you want more information or have issues with how things were handled, reach out to board members to tell them what is important to you.

One thing to keep in mind is that leadership is likely feeling some of the same emotions we are feeling. I know this from personally working with the AAHPM and HPNA staff. They put a lot of time and effort into making the 2022 Annual Assembly happen, and now a lot of that work is lost. So when reaching out to them for clarification or giving feedback, make sure to appreciate the ripple effects of COVID and that many of these decisions are often more difficult than they appear on the surface.

And if you still don't like how leaders are making decisions, then consider running for a volunteer position. Influence in a way that you think is best. There are always volunteer roles to fill. And it offers a perspective that things are often more difficult than they appear on the surface.

And lastly,I'm sorry that your work and the work of your colleagues and mentees won't get the attention of a national meeting. And yet, the good work is done. It just needs a little extra effort to find a home. Like one of my favorite quotes from Austin Kleon, "Do good work, and put it where people can see it." Already online, there are venues like HAPC Virtual Didactics, Friday Chalk Talk, GeriPal, and even Pallimed, making themselves available to repurpose or rework content. Honestly, this is something I would love to see our field do more of. Don't stop at "Well, I presented at the Annual Assembly. My work is done here." Call up colleagues at other institutions and let them know you have an excellent presentation for their next grand rounds. Do a media tour for the field: pitch your content to your local news media or write an editorial for national outlets like NYT, WaPo, The Atlantic, etc. Write a paper and publish it in an academic journal. Some of this you can do all on your own, some of it may require activating your mentor and peer network. So yes, feel your feelings, and then get to work finding a home for your great work. All is not lost.



For more Pallimed posts about AAHPM.
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For more Pallimed posts by Dr. Sinclair click here.



Christian Sinclair, MD, FAAHPM is a palliative care physician at the University of Kansas Health System, editor-in-chief of Pallimed,and trying to keep up a resolution to write more about palliative care in 2022.

Monday, January 24, 2022 by Christian Sinclair ·

Monday, January 17, 2022

Difficult Conversations About Racism

by Christian Sinclair (@ctsinclair)

There are many difficult situations we encounter in palliative care and hospice. Our training and experience equip us with words and skills to explore emotion-inducing topics. Yet there are still moments many clinicians can be caught speechless, and one of those is when we encounter racist language in the midst of our work.

If I had to pick the most influential article in 2021, it would be "Power, Silence, and Debriefing: Hidden Harms When Palliative Teams Encounter Racism" by Rev. Florence Moss and Dr. Kate McKillip, published in the Journal of Pain and Symptom Management in June 2021. I have shared it numerous times with colleagues and trainees, so much so, "Moss McKillip" regularly autofills on my search engine.

I was reminded of the power of this article with Rev Moss and Dr. McKillip presented for Friday Chalk Talk* led by Dr. Martin Bazelak this past week. If you are looking for speakers for your next Grand Rounds, I would put these two on your 2022 short list.

The article is a case based format, stemming from a real consult in which a patient used a racial slur, and there was no response in the moment. What follows is a very open portrayal of the debrief, which touches on the harm caused and the missed opportunities for responding in a way which supports the anti-racist work we should be supporting in health care. I am so appreciative of the thoughtful and honest writing by the authors. It was difficult for me to read the first few times, because I would frequently reflect on missed opportunities I have had in my career. It hurts to reflect on moments you could reduce harm to others, but you didn't. This is an important step, and it gets easier to read, because you can focus on the framework McKillip and Moss give to make better choices in the future.

One critical point is our communication tools of empathic silence and immediate debrief are not enough to handle these situations. McKillip and Moss let us in on their inner thoughts as they work through this case. They did a lot of work together to make things better for their own future work alone and together. They could have kept this work private, but they transformed it into something that could have a much larger impact in the world. I am so appreciative. I have already put some of their work into practice.

This article differs from other important work like the 2016 NEJM article Paul-Emelie, Smith, Lo and Fernández, "Dealing with Racist Patients." Most articles focus on what to do about the care of the patient now and in the future if they ask to be reassigned. That is important to consider as well, but what I appreciate about McKillip and Moss' work is that it focuses on the team, and the role we all must have in working towards a more caring and supportive community at work.

COI: Peer-to-peer mentorship - Mckillip, Bazelak

*Friday Chalk Talk is a great weekly resource. I need to write about that too!

For more Pallimed posts about race and healthcare.
For more Pallimed posts about ethics.
For more Pallimed posts by Dr. Sinclair click here.



Christian Sinclair, MD, FAAHPM is palliative care physician working in outpatient clincs at the University of Kansas Health System in Kansas City, KS. He currently is inspired to learn more about low-car transportation planning in cities like Berlin.

Monday, January 17, 2022 by Christian Sinclair ·

Monday, January 3, 2022

Cloaked Suffering

by Lyle Fettig (@FettigLyle)

The suffering in our hospital is cloaked by tinted windows and shiny new steel, a serene architectural specimen which betrays the internal chaos of each person who experiences illness behind each door.

Even for people who work there, it is sometimes surreal to approach the building in its beauty with the dissonant knowledge of what can happen in all manner of disease in between the walls. It’s the perfect place to hide the devastation of a pandemic.

Were the death and agony in the streets for all to see, perhaps the choices that are obvious to you and me would be obvious to all. How could a person not take every step they could to prevent this ongoing calamity?

This is not the bubonic plague to be seen in the gutters but rather a plague silenced by the plastic of the tubes you have placed in many airways hoping that after days, Weeks, Months, those voices will be heard again, knowing that some will go unheard for all of eternity.

Speak the truth with the ferocity and compassion I always hear from you. Tell the world what you have witnessed. Then go back into it with pride that no matter how your message has been received, you can rest your weary head knowing you have done the best this world will allow.

Originally published on Twitter Dec 27, 2021



For more Pallimed posts about COVID.
For more Pallimed posts by Dr. Fettig click here.



Dr. Lyle Fettig is an Assistant Professor of Clinical Medicine in the Department of Medicine/Division of General Internal Medicine and Geriatrics. Dr. Fettig directs the IUSM Palliative Medicine Fellowship and works clinically with the Eskenazi Health Palliative Care Program.



Monday, January 3, 2022 by Pallimed Editor ·

Tuesday, November 30, 2021

Say No! More - A Video Game Review

by Matthew Tyler (@pallidad)

Consider the last time you said “Yes” to something when you would have preferred to have said “No.” Maybe you worried saying “No” would damage a relationship. Or maybe you didn’t want to put your job at risk. In Studio Fizbin’s Say No! More you assume the role of a corporate intern on a quest to reclaim their lunch stolen by upper management. You go to battle with your manager, the C-suite, and beyond, wielding the power of a word never-before spoken within the walls of your office. Say No! More demonstrates in an over-the-top fashion how being able to say “No” can be a positive.

Although silly on the surface, Say No! More addresses the matter of social conditioning. From the moment we are born, we are taught to associate the word “Yes” with being agreeable and “No” with being disagreeable. As we age, our desire to be perceived as agreeable leads us to answer “Yes” to almost any question, even when it works against our best interests. As a facilitator of serious illness discussions, I am always looking for a way to frame questions so that the person feels comfortable answering in a way that honors their genuine selves. I realize people will often reflexively answer “Yes” and so I will rework questions to remove the onus of answering “No.”

Sharing serious news with a patient requires an environment conducive to discussion, and a big part of that is getting the timing right. A mindful clinician might first ask the patient “Is this a good time to talk?” but this phrasing risks receiving that reflexive “Yes” whether it’s actually a good time or not. We can work around this dynamic by instead asking “Is this a bad time to talk?” That way, the patient can give a “Yes” and will follow up with when it would be a better time, or they reply with a “No” that allows them to feel ownership of the conversation that follows. Timing is equally important when calling a family on the phone (where many serious conversations have been taking place these days). I often find clinicians diving in with difficult news the moment they hear “Hello” on the other end of the line. The obvious problem is that the person receiving the call could be in the middle of an important meeting or stuck driving in traffic. Asking “Is this a bad time?” disrupts the autopilot responses so common on distracted phone calls and creates the opportunity to either say “Yes” in a way that protects their needs in the moment or say “No” in a way that helps shift their focus to the conversation at hand.

Clinicians wishing to address questions of life prolonging therapy will often ask their patients questions like, “Do you still want us to do everything?” or “Would you like to go home?” Both questions can be problematic as they bias towards an affirmative response. Experts in serious illness communication recommend asking patients about what matters most to them before jumping into choices. Once the patient’s values are made explicit, we can pose a question that necessitates introspection and a prioritization of values regardless of whether the answer is “Yes” or “No.” That may sound something like this: “I am hearing that spending as much time at home with your family is very important to you, but that you are also interested in this clinical trial. Would you be willing to risk that time at home for the chance to extend your life?” In this case, “No” allows the patient to establish clear boundaries on treatment to preserve what they value most, whereas “Yes” makes explicit the hierarchy of their priorities to help the clinician offer their best advice on next steps.

Palliative care aims to help patients take control of their lives in the context of a serious illness. Creating space for patients to say “No” when needed is one way to foster that sense of control. Next time you need to have an important conversation with someone, consider how that discussion may be enriched by giving them the opportunity to Say No! More.

This post has a companion piece video hosted by Digital Doc Games (embedded below). Check out the Digital Doc Games YouTube channel hosted by Dr. Amiad Fredman for videos on how video games have a huge power to have a positive impact on people's lives.



Say No! More is available to play on PC (Steam), iOS and Nintendo Switch systems.



For more Pallimed posts about games.
For more Pallimed posts about culture and media.
For more Pallimed posts by Dr. Tyler click here.



Matt Tyler is a palliative care doctor in Chicago. If he's not watching Cocomelon with his daughters, he is probably playing video games.

References

1 Voss, C., Raz, T. (2017). Never split the difference: Negotiating as if your life depended on it. Random House Business Books

2 Ury, W. (2007). The power of a positive No: How to say No and still get to Yes. New York: Bantam Books.



Tuesday, November 30, 2021 by Pallimed Editor ·

Monday, November 22, 2021

The Limits of Advance Care Planning

by Michael Pottash (@mpottash)

Several luminaries of palliative care – writing in the Journal of the American Medical Association – recently outlined a strong case against advance care planning, referring specifically to advance directives and the efforts to plan for a future illness state. Planning for the end of life and documenting preferences was meant to improve “goal-concordant care” by providing a road map of a person’s wishes for the end of their life when they can no longer communicate for themselves.

When the United States Supreme Court ruled against the family of Nancy Cruzan, they effectively placed a limit on the right to refuse medical treatment for those unable to speak for themselves, declaring that while there may be a “right to die” even for an incapacitated patient, the state may require clear evidence to overrule its interest in the sanctity of life. In addition to the changing legal landscape came our growing anxieties around medical technology and its encroachment on the boundary between life and death. We have become enamored by the idea that clearly documented preferences, whether in a legal document or in a medical chart, could save us from some future purgatory between life and death.

As the advance directive industrial complex grew, it soon became en vogue to claim that the ubiquitous completion of these documents could even curb healthcare spending. The common wisdom became: 1) people don’t want aggressive medical interventions at the end of life - they want to die peacefully at home, and 2) medical interventions at the end of life (that people don’t really want anyway) is expensive, so 3) if we can get people to document their preferences, we can save a lot of money by avoiding unwanted, expensive medical interventions at the end of life.

The drum of discontent over advance care planning, especially advance directives, has been beating for a while now. In reviewing the landscape of evidence, it seems that advance directives may not be able to consistently influence end of life care in a measurable way. Therefore, it is not surprising that the theorized cost savings to the healthcare system never materialized. Not only do the vast majority of Americans not complete advance directives, but there is good evidence that they don’t actually want their documented preferences to be followed. They would rather have their doctor and someone they trust make those decisions in real time.

More concerning, focusing on advance directives may not even be ethical. It asks people to make decisions for their future disabled selves – often focusing on function and independence. Yet we know that people are generally more resilient than they believe and adapt to all kinds of changed and debilitated states. We also know that able bodied people tend to discount the quality of life of someone living with a disability, even when that person is our future selves. This issue alone has driven a wedge between the disability community and medicine, and continues to be a blemish on the otherwise inclusive culture of palliative care. There are serious ethical problems in asking people to decide today what their future selves would consider a life worse than death.

In the JAMA article, the authors recommend that advance directives and future-oriented conversations be deemphasized in favor of 1) documenting a healthcare surrogate - someone to relay our values and guide clinicians based on what they believe would be in our best interests - and 2) training clinicians to have “high-quality discussions” in the moment, when “actual (not hypothetical) decisions must be made.” That makes a lot of sense. And yet, we still require a framework for how to care for our patients before critical illness and end of life, for those patients still living with serious illness. What are the metrics of success if not completing advance directives or documenting future preferences? In our outcomes obsessed healthcare system, where is the value in informing our patients of what to expect in the future?

Perhaps a better framework for thinking about these future-oriented conversations is to be found in the work being done as part of Ariadne Labs Serious Illness Care Program and others like it. This program is training clinicians to have Serious Illness Conversations with their patients before they end up in the final stage or in intensive care. Instead of measuring success in outcomes, such as an advance directive or a documented preference, they want to know if patients and their clinicians find these conversations valuable. For example, they ask patients: 1) Did this conversation give you a greater (or lesser) sense of control? 2) Did you get the right amount of information from this discussion? And they ask clinicians: 1) Did you learn something surprising about your patient? 2) How did this discussion affect your patient’s emotional state? 3) Did your patient have a good understanding of prognosis? They seem to favor process questions: Were these conversations feasible, acceptable, and were you satisfied?

This approach to serious illness conversations – focusing on the process of informing and tending to emotion in lieu of attempts to influence future outcomes – may be a big (and possibly disappointing) paradigm shift for our outcomes-driven health system. Occasionally, Medicine’s role is to heal or to cure, sometimes it is to ease suffering, and often, all it can do is inform and provide counsel. It can be hard for us clinicians to realize that we cannot fix. Sometimes the only reason to do something is because it is what patients expect, it is what they need, and because it is the right thing to do. Is that enough of a reason to invest resources in hiring people to do this work, and to train others to become proficient? Though it may not lead to universal “goal-concordant care” or to cost savings, is it enough for us to do it because it is right? And can we live with that?

For more Pallimed posts about Advance Care Planning.
For more Pallimed posts by Dr. Pottash click here.

Michael Pottash MD MPH is a Palliative Medicine Physician at MedStar Washington Hospital Center and Associate Professor of Medicine at Georgetown University School of Medicine.


Monday, November 22, 2021 by Pallimed Editor ·

Friday, September 17, 2021

Roger Chou’s Undisclosed Conflicts of Interest: How the CDC’s 2016 Guideline for Prescribing Opioids for Chronic Pain Lost Its Clinical and Professional Integrity

by Chad D. Kollas MD, Terri A. Lewis PhD, Beverly Schechtman and Carrie Judy

“I'm present. Uh … I do have a conflict. I receive funding to conduct reviews on opioids, and I'll be recusing myself after the um, director's, uh, um, um, uh… update.”

- Dr. Roger Chou, Center for Disease Control and Prevention (CDC) National Center for Injury Prevention and Control (NCIPC) Board of Scientific Counselors (BSC) Meeting Friday, July 16, 2021.

Introduction
For those familiar with the controversial relationship between the anti-opioid advocacy group, Physicians for Responsible Opioid Prescribing (PROP, recently renamed, Health Professionals for Responsible Opioid Prescribing), and the Centers for Disease Control’s CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016, (2) (hereafter called “the 2016 Guideline”), Dr. Roger Chou’s disclosure represented a stunning admission (3, 4). Chou had originally announced his intention to help influence opioid policy in a 2011 article that he co-authored with PROP’s founders (5), and he was a bold signatory to PROP’s 2012 Petition to the Food and Drug Administration (FDA) to change opioid labeling (6; See Figures 1a and 1b: First page and signatory page.)

Figure 1a: First Page of PROP Petition to FDA


Figure 1b: Signatory Page of PROP Petition to FDA


Through his participation in these PROP activities, Chou established himself as a significant contributor to PROP efforts. Yet he never formally served as a leader or member of PROP, and until the CDC NCIPC-BSC Meeting on July 16, 2021, Chou avoided all allegations of conflicts of interest (COI) between his opioid research and co-authorship of the 2016 Guideline, unlike several other PROP members (2). Given that the CDC had strict reporting guidelines for COI’s for those involved in the creation of the 2016 Guideline, Chou’s startling disclosure raises many important questions about his involvement in the original publication. It also raises many concerns about his role in the creation of any “draft, updated and/or expanded Guideline (hereafter called the “2022 Guideline”) that might arise from such conflicts (7).

Did Chou fail to disclose a prior conflict of interest (COI) when he drafted the 2016 Guideline? Wouldn’t such a failure to disclose a past COI undermine the integrity of that Guideline? Does Chou’s recent COI disclosure compromise the integrity of the upcoming 2022 Guideline, even before its publication? In making such a mysterious disclosure, was Chou recusing himself from the July 16, 2021, CDC NCIPC/BSC meeting only, or did his statement refer to a recusal from the 2022 Revised and Expanded Guideline entirely? The answers to these questions have profound implications for the CDC’s Opioid Prescribing Guideline’s professional integrity and clinical credibility. This could, in turn, substantially bring into question the CDC’s entire national opioid policy, both in how it was applied in the past, as well as how it might be viewed in the future.

PROP’s Beginnings (2000-2015): Washington State’s War on Opioids in Labor and Industries (the state’s Workman’s Compensation Program)

The AMDG Pain Guidelines

Chou’s entanglement with competing interests began years before the CDC began the process of creating its 2016 Guideline, rooted in the state of Washington’s war on opioids prescribed to Labor and Industry recipients. In 2005, Gary Franklin, MD, MPH, Director of the Labor and Industry Program, who would later become PROP’s Vice President of State Regulatory Affairs, published an article alleging that “that tolerance or opioid-induced abnormal pain sensitivity may be occurring in some workers who use opioids for chronic pain (9).” He concluded that “[o]pioid-related deaths in this population may be preventable through use of prudent guidelines regarding opioid use for chronic pain (7).” Franklin also served on the Washington State Agency Medical Directors Group (AMDG) via the Washington State Department of Labor and Industries (9).

By 2007, the Washington State Agency Medical Directors Group (AMDG) published its “Interagency Guideline on Opioid Dosing for Chronic Non-Cancer Pain (8),” which was updated in 2010 and 2015 (11). This guide introduced the concept of a hard dosing threshold for opioid analgesics, despite an FDA criticism that the concept lacked scientific support and encouraged reduced opioid prescribing or tapering of opioid doses based on these arbitrary thresholds (2, 11). It was also used by the Washington State Department of Labor & Industries to guide prescribing for the state’s “Medicaid patients, Workers’ Compensation recipients, and state employees,” which led to increased use of methadone, which Franklin selected as a less expensive alternative to other opioid analgesics (12).

Harms from the Workmen’s Compensation Program and AMDG Pain Guidelines

The harms from the AMDG Pain Guidelines as applied to Washington’s Workers’ Compensation and Medicaid programs had become evident by 2009. Scott Fishman, MD, and Lynn Webster, MD publicly criticized AMDG’s hard dosing threshold for opioid analgesics, particularly regarding the use of methadone (15) They noted that while a “starting dosing regimen of 10 mg of methadone four times per day, as allowed by most conversion tables, would fall below the 120-mg morphine equivalent level… this amount of methadone [had] been fatal in some instances (15).” They further noted that the AMDG failed to collaborate with pain management experts when creating its guideline and cited formal opposition to the AMDG Guideline by multiple professional pain societies: the American Academy of Pain Medicine (AAPM), the American Pain Foundation (APF) and the American Pain Society (APS) (14).

In a Pulitzer-prize winning series published in the Seattle Times, investigative reporters Michael J. Berens and Ken Armstrong reported that while encouraging prescribers to use methadone may have saved the state of Washington millions of dollars, it also resulted in the deaths of many of the state’s Medicaid recipients (14, 16). The series highlighted the egregious harms suffered by Washington’s “Medicaid patients, Workers’ Compensation recipients and state employees” due to increased use of methadone, encouraged by Franklin via the AMDG Guideline (12). Their reporting prompted the state of Washington to “issue a public health advisory that singles out the unique risks of methadone” as contributing to the deaths of at least 2,173 people between 2003 and late 2011 (14). Despite the identification of these recognized harms, the forces behind the creation of the AMDG Guidelines broadened their efforts to reduce opioid prescribing when they joined forces with PROP, a group whose creation Chou had announced in a co-authored article in 2011 (4).

Exploring Chou’s COIs in co-authoring the Centers for Disease Control’s CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016 (2008-2018)

The Significance of the CDC’s Reporting Requirements for Conflicts of Interest

Prior to participating in the creation of the 2016 Guideline, CDC stated the following with regard to handling potential conflicts of interest (COIs):

• Experts must reveal possible conflicts of interest, such as financial relationships with industry, intellectual preconceptions, or previously stated public positions (18).

• Experts could not serve if they had conflicts that might have a direct and predictable effect on the recommendations (Italics ours, 18).

• They ‘excluded experts who had a financial or promotional relationship with a company that made a product or that might be affected by the guideline.’ (18).

• They had reviewed potential nonfinancial conflicts carefully (e.g., intellectual property, travel, public statements, or positions, such as congressional testimony) to determine if the activities would have a direct and predictable effect on the recommendations (18).

• They determined the risk of these types of activities to be minimal for the identified experts (18).

• All experts completed a statement certifying that there was no potential or actual conflict of interest (18).

• Activities that did not pose a conflict (e.g., participation in Food and Drug Administration [FDA] activities or other Guideline efforts) were disclosed (18).



Based on this, CDC had two main categories of COIs for which it excluded participation in the creation of the 2016 Guideline: 1) financial conflicts and 2) non-financial conflicts, specifically a conflict that “might have a direct and predictable effect on the recommendations (18).” CDC originally published that no members (italics ours) of the 2016 Guideline Core Expert, Peer Reviewer, or Technical Expert groups had any COI’s that were in violation of CDC’s conflicts policies. However, years after the 2016 Guideline was published, members of PROP eventually disclosed multiple serious conflicts of interest. For example, PROP President, Jane Ballantyne, MD, disclosed “that she has served as a paid consultant to Cohen Milstein Sellers and Toll, PLLC, and has special advisory committee responsibilities on the Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategies Committee (18).” PROP Board Member, Gary Franklin, MD, MPH, disclosed “authorship of the AMDG Interagency Guideline on Prescribing Opioids for Pain (18).” Otherwise, the Core Expert Group (CEG) members and Opioid Guideline Workgroup (OGW), both of which included Chou, a PROP ally, “disclose[d] that they have no financial conflicts of interest (4,18).” Of note, Roger Chou, also disclosed no non-financial COIs related to the professional content of his contributions to the 2016 Guideline (18). Thus, it is now clear that the CDC did not hold the authors and contributors to the 2016 Guideline to its own clearly stated conflicts of interest and ethical policies.

Chou’s Non-Financial COIs in the 2016 Guidelines: Co-Authorship of Opioid Reviews and Professional Criticisms Regarding His Flawed Methodologies

In 2008, Chou authored an article for a special issue of Pain Medicine about interpreting and applying systematic reviews and clinical practice guidelines (19), an activity that one would have reasonably expected to “have a direct and predictable effect on the recommendations (18)” on the 2016 Guideline. A group of physicians, including the lead author of four articles in that same special issue of Pain Medicine (20-23), criticized Chou’s misinterpretation of pain guidelines by the American Society of Interventional Pain Physicians (ASIPP) in the special issue (24):

• They noted that Chou had “focused solely on randomized clinical trials; consequently, [the] evidence may be misinterpreted (24).”

• They further explained that it “is not the stringent standard which shows the evidence, or lack therefore of, but developing guidelines without appropriate expertise on the subject and randomized trials performed by non-specialist academicians (Italics ours, 24).

• They concluded that “[w]ithout any proof that evidence-based medicine is effective and it is based on evidence, it will be best if evidence synthesizers follow the rules appropriately, rather than injecting personal, biased opinions (Italics ours, 24.)”



Similarly, in 2010, a group of authors again took issue with Chou’s interpretation (25) of the American Pain Society (APS) Clinical Practice Guidelines for Interventional Techniques (23):

• Specifically, they wrote that Chou “utilized multiple studies inappropriately and… excluded appropriate studies (26).”

• They also asserted that Chou failed to eliminate bias in his evaluations of the APS Clinical Practice Guidelines for Interventional Techniques (24) …

• Which one would again reasonably expect to “have a direct and predictable effect on the recommendations (21)” on the 2016 Guideline.



Additionally, in 2014, Chou co-authored a systematic review and critical appraisal of guidelines for chronic pain (27). The article concluded, “Despite limited evidence and variable development methods, recent guidelines on chronic pain agree on several opioid risk mitigation strategies, including upper dosing thresholds; cautions with certain medications; attention to drug-drug and drug-disease interactions; and use of risk assessment tools, treatment agreements, and urine drug testing (27).” Ironically, in 2013 Chou had co-authored an AHRQ-sponsored article in which he stated, “Since evidence syntheses depend on the published literature accurately representing what’s known about medical therapies, reporting biases threaten the veracity of what we know (italics ours, 28). This indicates that Chou understood reporting bias, co-authored reviews of guidelines for managing chronic pain, but failed to report what a reasonable individual would correctly interpret as a conflict that “might have a direct and predictable effect on the recommendations,” prior to or during his co-authorship the 2016 Guideline (18). Under the CDC’s rules for inclusion in the creation process of its 2016 Guideline, Chou should have disclosed these conflicts before contributing as a co-author, and these conflicts should have disqualified him from participating in the process of creating the 2016 Guideline (Italics ours.) This is particularly concerning when taken in context with concerns about the strength of evidence upon which the 2016 Guideline were based. As the American Medical Association noted, “It seems incongruous that virtually all of the specific guidelines carry a graded recommendation that CDC believes should ‘apply to all patients with chronic pain and that… most patients should receive the recommended course of action,’ given the limitations of the evidence, especially where CDC experts’ opinions are the essential foundation for the recommendation (Italics ours; 29).”

Chou’s Financial COIs in Both Pain GLs: Funding from PROP/Group Health/Kaiser, AHRQ and the CDC Foundation

Chou also shared financial conflicts through his relationship with PROP and its funding, which “might have a direct and predictable effect on the recommendations” of the 2016 Guideline (18). As mentioned earlier, Chou was a co-author of a 2011 journal article that announced the formation of PROP, and while PROP has resolutely avoided identifying its donors over the last decade, Chou’s group received funding from Group Health Foundation, which lead-author, Michael Von Korff, disclosed as a potential conflict of interest at the time (4). The Group Health Foundation and PROP co-sponsored a National Summit on Opioid Safety on October 16, 2012 (30), during which Chou provided the keynote address, acknowledged funding from the Agency for Healthcare Research and Quality (AHRQ), and disclosed a financial relationship with Palladian Health for implementation of low back pain guidelines (31).

Palladian Health described itself as “comprehensive muscular skeletal health care company that integrates physical therapy, chiropractic, health and fitness with patient care advocacy to improve clinical and economic outcomes,” and listed Chou as a member of its Clinical Advisory Board (32). This represented a conflict with both financial and non-financial implications for his co-authorship of the 2016 Guideline. More importantly, Oregon Health and Science University (OHSU), Chou’s employer, announced on August 31, 2012, that it had received from AHRQ a five-year contract to serve as an Evidence-Based Practice Center, which funded Chou’s work (33). In the 2016 Guideline, Chou acknowledged that he had represented the Oregon Health and Science University with funding from his 2014 systematic review and critical appraisal of guidelines for chronic pain coming from AHRQ Grant HS17954 (18). This marked the beginning of an early funding loop between PROP (through Group Health Foundation, at that time) and AHRQ for work that Chou used to create the 2016 Guideline.

Over the next several years, Chou would expand this tangled web of financial conflicts of interest by adding the CDC Foundation as an indirect funder for his clinical reviews on opioid analgesics. According to its website, “The CDC Foundation is an independent nonprofit and the sole entity created by Congress [in 1992] to mobilize philanthropic and private-sector resources to support the Centers for Disease Control and Prevention’s critical health protection work (34, 35).” Of note, as part of its policy to avoid conflicts of interest, the CDC Foundation is prohibited from “[p]artnership with an organization that represents any product that exacerbates morbidity or mortality when used as directed (36).

Kaiser Permanente acquired Group Health Cooperative in 2017 and formed a new 501(c)(4) foundation from the proceeds from the acquisition, which “was previously part of Group Health Cooperative [but would then] operate collectively as ‘Group Health Foundation’ (37, 38).” The Kaiser Foundation Hospitals Centers for Health Research, which is part of the Kaiser Permanente Center for Health Research (39), is listed as a philanthropic donor to the CDC Foundation (40). In retrospect, Kaiser Permanente attended, as an invited guest, a 2015 online CDC webinar during which the CDC unveiled the 2016 Guideline, which was met with fierce criticism from other medical professional stakeholders (41). By the time the 2016 Guidelines were released, the CDC Foundation was firmly established as part of the Chou self-funding loop already created by PROP/Group Health/Kaiser Permanente and AHRQ.

On November 20, 2018, Chou’s employer, the Oregon Health and Science University, received a delivery order, funded by the AHRQ under Evidence-based Practice Centers, with a potential value of $500,000 (42). The streaming of this funding became clearer in December 2019, when the AHRQ awarded the Pacific Northwest Evidence-based Practice Center (EPC), a program within OHSU directed by Roger Chou, a five-year contract “to develop evidence reviews to inform healthcare decision-making [sic]; promote the uptake of evidence, including health systems; and invest in research methods to improve the quality, usefulness and efficiency of evidence reviews (43).” Chou publicly acknowledged his funding from AHRQ in a presentation at AMDG's "Patient-Centered Approach to Chronic Opioid Management Conference," held on August 9, 2019 (45). Chou, again publicly, albeit in a quiet, subtle way, acknowledged his AHRQ funding as a relevant financial COI in a correction to an article published in Annals of Internal in November 2019 (46, 47). The full extent of Chou’s COI disclosure is only revealed when one follows the link to the article’s complete International Committee of Medical Journal Editors (ICMJE) Disclosure of Interest form (48). Furthermore, while Chou disclosed his financial relationships with AHRQ and CDC related to “funding to conduct reviews on opioids for chronic pain,” he characterized this conflict as relevant activity outside of the submitted work (48). In doing so, he avoided being directly identified as failing to disclose a COI in the Correction published by Annals of Internal Medicine, which explicitly called out PROP members Anna Lembke, MD and Jane Ballantyne, MD, instead (47). More specifically, Ballantyne finally disclosed her involvement with PROP and her consultative fees for consulting in the multibillion-dollar Multi District Opioid Litigation. Lembke also took this belated opportunity to disclose her involvement with PROP (47, 48). They also clarified that the article had misrepresented PROP as “A 501(c)(3) charitable organization (47, 48),” although “PROP is not a registered charity with the Internal Revenue Service (49).”

The Yet-to-be-Released, Revised and Expanded 2022 Guideline (2018-Present)

By the end of 2019, AHRQ had delivered the full amount of its $500,000 award to OHSU for the work done by Chou’s Pacific Northwest EPC (50), and unbeknownst to anyone but the CDC, Chou had moved on to co-authoring the expanded 2022 Guideline. Just a few months later, in April 2020, PROP and Chou were again linked to an AHRQ-funded study examining the “effectiveness of opioids in treating chronic pain (51).” In trying to determine whether PROP and Chou would be involved in writing the 2022 Guideline, Pain News Network filed a request to CDC under the Freedom of Information Act (FOIA). However, PNN received 1,500 pages of documents “so heavily redacted they were completely blank (52, 53; See Figure 2 Below). PNN has filed an appeal for the CDC’s violations of this FOIA request.

Figure 2: CDC’s Redacted Replies to the FOIA Request from PNN




In June 2021, the AHRQ solicited public comments on its Draft Report on Integrated Pain Management Programs, although the draft report is no longer available for review (53, 54). Many stakeholders submitted review comments, including the lead author on this article, who expressed a concern about the AHRQs policy for handling potentials COIs in its report, specifically AHRQ’s statement that “Technical Experts must disclose any financial conflicts of interest greater than $5,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content expertise, individuals with potential conflicts may be retained. The TOO and the EPC work to balance, manage, or mitigate any potential conflicts of interest identified (55).”

A month later, during the Roll Call for the Center for Disease Control and Prevention (CDC) National Center for Injury Prevention and Control (NCIPC) Board of Scientific Counselors (BSC) Meeting, Roger Chou disclosed a COI related to receiving “funding to conduct reviews on opioids (1).” In the BSC-NCIPC meeting’s immediate aftermath, participants posted written comments that cited Chou’s COI disclosure as a cause for questioning the legitimacy of his role in co-authoring both sets of Opioid Prescribing Guidelines, especially because of his long-term relationship with PROP (2, 56). Advocate Tamera Lynn Stewart offered live comments during the meeting that bluntly addressed concerns about Chou’s financial COIs (57): “Chou’s been involved in calling for opioid guidelines or restrictions since around 2011. The CDC gets funding for these guidelines, the CDC pays AHRQ to write reviews on which these guidelines are going to be based. AHRQ not only contracts with Dr. Chou to conduct reviews of the opioid studies, but Chou also helped set the AHRQ priorities. Chou is one of the five authors who wrote the draft of the [CDC Opioid Prescribing] Guidelines based on the reviews he was paid to create. Finally, Chou is on the Board of Scientific Counselors, who approves or denies any opposition comments from the (Opioid) Working Group and, being on the BSC, Chou has a say in the final approval of the Guidelines themselves. All of this, and there’s no mention of a conflict of interest until today, July 16th, around 9 AM (57).”

Ultimately, the Opioid Work Group (OWG) of the CDC NCIPC-BSC expressed multiple serious concerns about the 2022 Guideline, “warning the CDC that a draft revision of its 2016 Opioid Prescribing Guideline is focused too heavily on the risks of taking opioid medication, with not enough attention paid to the benefits that opioids have for many pain patients (58).” Chou’s COI disclosure and recusal from the CDC BSC-NPIPC meeting on July 16, 2021, also had many stakeholders wondering whether this signaled an end to his involvement in the further development and roll-out of the 2022 Guideline (1). The answer came at the next scheduled meeting of the CDC BSC-NPIPC, when, on July 29, 2021, during the Roll Call, Chou listed himself as, “Present, no conflicts (59).” This implies that his COI disclosure and self-recusal during the CDC NCIPC-BSC Meeting on July 16, 2021 (1), was meant only for that meeting.

Growing Evidence of Emerging Harms from the CDC Pain Guidelines

Harms from Opioid Tapering

By early 2018, it became increasingly clear to clinicians that misapplication of the Chou co-authored 2016 Guideline had begun to result in serious patient harms (60). This included concerns about a growing number of “suicides within and outside of the Veterans Affairs Healthcare System in the United States” from forced or involuntary tapers off opioid analgesics (60). In response to growing reports of patient harms from misguided opioid policies, in November 2018, the American Medical Association adopted a new policy that opposed hard dosing limits for opioid analgesics, encouraged individualized care when prescribing opioids, and called for the AMA to advocate against ongoing misapplication of the 2016 Guideline (61). By March 2019, an array of medical professional stakeholders had submitted written requests to CDC to speak out against misapplication of its 2016 Guideline, especially regarding their opposition of involuntary opioid tapers due to rising concerns about patient harms (62-64). These efforts prompted both the Food and Drug Administration (FDA) and the CDC to issue public announcements opposing the sudden discontinuation of opioid pain medicines and misapplication of the 2016 Guideline (65-67).

Despite these warnings, researchers have documented growing clinical evidence of patient harms arising from CDC’s opioid policies. In May 2019, Medicaid patients in Vermont who experienced “faster rates of opioid tapering” suffered from “a greater probability of adverse events” than those not tapered or tapered more slowly (8). An August 2019 study noted that opioid tapering was associated with termination of care in 78 of 207 cases (38%), prompting the authors to recommend caution when considering tapers and calling for more research to “fully understand the risks and benefits of opioid tapers (69).” By March 2020, a group researching patients in the Veterans Health Administration observed that “patients were at greater risk of death from overdose or suicide after stopping opioid treatment, with an increase in the risk the longer patients had been treated before stopping (70).” They further noted that “strategies to mitigate the risk in these periods are not currently a focus of guidelines for long term use of opioids (70).” Results such as these prompted a group of clinicians to conclude in June 2020 that policies mandating nonconsensual opioid dose reductions are “not justified clinically or ethically (71).” More recently, a retrospective cohort study of pharmacy claims and enrollment data found that “among patients prescribed stable, long-term, higher-dose opioid therapy, tapering events were significantly associated with increased risk of overdose and mental health crisis (72).

Harms to Patients with Cancer Pain or Receiving Palliative Care


Of greater concern than harms from tapers, several 2021 studies suggest that misapplication of the 2016 Guideline has begun to affect patients who were not intended targets for the 2016 Guidelines: patients with cancer pain or those receiving palliative care. Specifically, “the Guideline [was] not intended for patients undergoing active cancer treatment, palliative care, or end-of-life care because of the unique therapeutic goals, ethical considerations, opportunities for medical supervision, and balance of risks and benefits with opioid therapy in such care (2).” For reasons that were not clarified by its authors, the 2016 Guideline apply to “cancer survivors with chronic pain who have completed cancer treatment, are in clinical remission, and are under cancer surveillance only (2),” without considering legacy status or the frequent presence of well-recognized chronic, cancer-related pain syndromes, which often require multi-modal care for sufficient management, including opioid analgesia, when medically appropriate (73).

In a recent study examining prescriptions dispensed to patients with painful bone metastasis from active cancer using a large commercial claims database, opioid prescribing declined significantly between 2011 and 2017 (74). The authors expressed concerns that claims data did “not provide information regarding clinical indication or appropriateness of opioid prescriptions,” and expressed worry that a decline in opioid prescribing to this group of patients may lead to “a rising rate of undertreated pain (74).” A similar study examined Emergency Department (ED) visits by patients dying from cancer and observed that “opioid use among patients dying of cancer has declined substantially from 2007 to 2017. Rising pain-related ED visits suggests that EOL cancer pain management may be worsening (75).” Furthermore, a recently published study that used structured interviews of patients with advanced cancer found that “the US opioid epidemic has stigmatized opioid use and undermined pain management in individuals with advanced cancer (76).” Despite growing evidence of increasing harms to patients, the CDC has not issued any additional, substantive announcements since April 2019 (67). In fact, despite acknowledging inaccuracies in its own overdose death data, the CDC recently doubled down on rhetoric about prescription opioids: “Regardless of the method used to calculate the total numbers, prescription opioids continue to be involved in a significant proportion of drug overdose deaths (77).”

Where Should We Go from Here?

In this article, we have provided substantial evidence that Roger Chou’s conflicts of interests, undisclosed to the public before the July 16, 2021, had “a direct and predictable effect on the recommendations” contained within the 2016 Guideline, the very language used by the CDC to define a relevant conflict. By virtue of his COI disclosure on July 16, 2021, Chou’s role as a co-author and reviewer of the 2022 Guideline has compromised the professional and clinical integrity of the 2016 Guidelines, and the entire creation process of the Guideline has undermined the credibility of the CDC. Put simply, Roger Chou has been placed in the position of “advocating his own work as national healthcare policy (78).” Despite this, when confronted by stakeholders about harms arising from misapplication of the Pain Guidelines, the CDC response was limited at best (67) or defiant at worst (78).

Given this, we offer the following robust recommendations, several of which enjoy the support of prominent stakeholders seeking balanced opioid policy (79, 80):

1) The CDC should immediately rescind the most harmful or misapplied portions of the 2016 Guideline. This should include renouncing and rescinding arbitrary dosing thresholds, commonly referred to as MME, by health insurers, state and federal governments and pharmacies (81). It should also include a ban against involuntary opioid tapers.

2) The CDC should announce its strong commitment to balanced opioid policy, including individualized care for patients with chronic pain, explicitly acknowledging that some patients with chronic pain – especially those with serious illness – may benefit from treatment of opioid analgesics when medically appropriate.

3) The CDC should suspend indefinitely any plan to implement its 2022 Guideline, which are currently expected to be published in the Federal Register in late 2021. (82).


In addition to these measures, we call on the United States Congress or the U.S. Department of Justice to investigate Roger Chou, PROP and the Centers for Disease Control to determine whether they violated any federal laws or policies when creating either the 2016 or the expanded 2022 Opioid Prescribing Guidelines. We also encourage legal scholars to examine the harms inflicted upon patients with chronic pain as result of the 2016 Guideline, or from their misapplication, to determine whether these harms could be remedied through litigation. Undoing the ongoing harms of the CDC’s Opioid Prescribing Guideline for Chronic Pain and preventing further harms from the expanded 2022 Guideline - which were drafted with all the same ethical conflicts of the 2016 Guideline yet will affect even more patient populations - is an imperative for all invested in public health and the treatment of pain. Undoing the harms of the CDC Pain Guidelines represents a critical step in restoring balanced pain policy, which must include access to judiciously prescribed opioid analgesics, to the millions of Americans living with chronic pain every day of their lives.

About the Authors

Lead author, Chad Kollas, serves as the Medical Director for Palliative and Supportive Care at the Orlando Health Cancer Institute in Orlando, FL. He can be reached by e-mail at chad.kollas@orlandohealth.com or via Twitter at @ChadDKollas.

Terri A. Lewis serves in Rehabilitation and Mental Health Counseling, National Changhua University of Education (NCUE), in Changhua, Taiwan/Republic of China.

Bev Schechtman is a chronic pain and illness patient who has spent the last four years volunteering as a patient advocate. She is currently the VP of the non-profit, The Doctor Patient Forum, and she has been with the volunteer organization, Don't Punish Pain, since its inception in 2017. She is a passionate researcher and advocate and hopes to give a voice to those in pain.

Carrie Judy is an unpaid contributor and researcher at The Doctor Patient Forum.

Competing Interests

Dr. Kollas currently serves as the Secretary of the Board of Directors of the American Academy of Hospice and Palliative Medicine (AAHPM). He also serves as the AAHPM Delegate to the American Medical Association (AMA) House of Delegates, he is the Chair of the AMA Pain and Palliative Medicine Specialty Section Council and is a member of the AMA Opioid Task Force. Dr. Kollas has provided testimony at a 2004 Congressional Hearing on OxyContin. Dr. Kollas has served as a medical expert witness in cases involving opinions regarding the standard of care in internal medicine and hospice and palliative medicine. He has received educational research grants from the AMA Education and Research Foundation, Geisinger Clinic and M. D. Anderson Cancer Center Orlando. He serves as the editor for the Advocacy section of AAHPM Quarterly and is a member of the Editorial Advisory Board and review for the Journal of Pain and Symptoms Management. He has also served as a reviewer for the Journal of Palliative Medicine, Annals of Internal Medicine, Journal of General Internal Medicine, Journal of Graduate Medical Education, and the Educational Clearinghouse for Internal Medicine.

Dr. Lewis, Ms. Schechtman and Ms. Judy report no competing interests.

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Pallimed posts by Dr. Kollas click here. References

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26. Manchikanti L, Datta S, Derby R, Wolfer LR, Benyamin RM and Hirsch JA. A Critical Review of the American Pain Society Clinical Practice Guidelines for Interventional Techniques: Part 1. Diagnostic Interventions. Pain Physician. May/June 2010; 13:E141-174.

27. Nuckols TK, Anderson L, Popescu I, Diamant AL, Doyle B, Di Capua P, Chou R. Opioid prescribing: a systematic review and critical appraisal of guidelines for chronic pain. Ann Intern Med. 2014 Jan 7;160(1):38-47

28. Balshem H, Stevens A, Ansari M, Norris S, Kansagara D, Shamliyan T, Chou R, Chung M, Moher D, Kay Dickersin K. Finding Grey Literature Evidence and Assessing for Outcome and Analysis Reporting Biases When Comparing Medical Interventions: AHRQ and the Effective Health Care Program. In: In: Methods Guide for Effectiveness and Comparative Effectiveness Reviews [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008–. AHRQ Methods for Effective Health Care. 2013 Nov 18.

20. Madara JL. Letter to Thomas Freiden, Director, Centers for Disease Control and Prevention. Re: Docket No. CDC-2015-0112; Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain. January 12, 2016. See https://searchlf.ama-assn.org/undefined/documentDownload?uri=%2Funstructured%2Fbinary%2Fletter%2FLETTERS%2Fcdc-opioid-guidelines-12jan2016.pdf.

30. See https://www.slideshare.net/grouphealth/national-summit-on-opioid-safety.

31. See https://www.slideshare.net/grouphealth/3-chou-opioid-summit-10-31-12.

32. Palliadian Health, LLC. Palladian's Distinguished Clinicians Present at APTA's National CSM Convention in San Diego on 'Evidenced Informed Management of Chronic Low Back Pain Without Surgery.’ March 16, 2010. See https://www.prnewswire.com/news-releases/palladians-distinguished-clinicians- present-at-aptas-national-csm-convention-in-san-diego-on-evidenced-informed- management-of-chronic-low-back-pain-without-surgery-87763542.html.

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34. See https://www.cdcfoundation.org/our-story.

35. See https://www.cdcfoundation.org/FAQ.

36. See https://www.cdcfoundation.org/guiding-principles-partner-collaboration.

37. See https://grouphealthfoundation.org/about-ghf/faqs/.

38. See https://www.gih.org/grantmaker-focus/group-health-foundation/.

39. See https://research.kpchr.org/

40. See https://www.cdcfoundation.org/partner-list/foundations

41. Anson P. Special Interest Groups Behind CDC Opioid Guidelines. Pain News Network, September 24. 2015. See http://www.painnewsnetwork.org/stories/2015/9/24/3xz1qq23yuilyeluz63kgwckplwh21.

42. See https://govtribe.com/award/federal-contract-award/delivery-order-hhsa290201500009i-75q80119f32018.

43. See https://effectivehealthcare.ahrq.gov/news/epc-contracts-awarded-december-2019.

44. See https://www.ohsu.edu/evidence-based-practice-center/about.

45. Chou R. Reviewing the Evidence on Outcomes of Opioid Tapers. Patient-Centered Approach to Chronic Opioid Management Conference, August 9, 2019. See http://www.agencymeddirectors.wa.gov/Files/COTS/4_Chou_Tapering%20Bree%20Collaborative%208.19_revised.pdf.

46. Chou R, Ballantyne J, Lembke A. Rethinking Opioid Dose Tapering, Prescription Opioid Dependence, and Indications for Buprenorphine. Ann Intern Med. 2019 Sep 17;171(6):427-429. doi: 10.7326/M19-1488. Epub 2019 Aug 27. Erratum in: Ann Intern Med. 2019 Nov 5;171(9):684. PMID: 31450240.

47. Correction: Rethinking Opioid Dose Tapering, Prescription Opioid Dependence, and Indications for Buprenorphine. Ann Intern Med. 2019 Nov 5;171(9):684. doi: 10.7326/L19-0595. Erratum for: Ann Intern Med. 2019 Aug 27;:null. PMID: 31683287.

48. See https://rmed.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-1488&_ga=2.63881967.1144280822.1629813752-857333589.1616690931.

49. Anson P. PROP President Discloses Conflicts of Interest, Pain News Network, November 12, 2019; https://www.painnewsnetwork.org/stories/2019/11/12/prop-president-discloses-conflicts).

50. See https://govtribe.com/award/federal-contract-award/delivery-order-hhsa290201500009i-75q80119f32018.

51. Anson P. PROP Linked to New Federal Opioid Study. Pain News Network, April 20, 2020. See https://www.painnewsnetwork.org/stories/2020/4/20/prop-linked-to-new-federal-opioid-study.

52. Anson P. What is the CDC Trying to Hide? Pain News Network, April 16, 2020. See https://www.painnewsnetwork.org/stories/2020/4/15/what-is-cdc-trying-to-hide.

53. See, for example, https://www.aapmr.org/members-publications/member-news/member-news-details/2021/06/08/ahrq-seeks-comments-regarding-two-pain-management-systematic-reviews.

54. Formerly https://effectivehealthcare.ahrq.gov/products/integrated-pain-management/draft-research. As of August 24, 2021, this link is no longer active; please contact the authors for a PDF copy of this document.

55. Kollas CD. Comments on the AHRQ Draft Report on Integrated Pain Management Programs. Submitted to AHRQ on June 7, 2020. PDF available from authors by request.

56. Lawhern R. Comments to the July 16, 2021 Meeting of The US CDC National Center for Injury Prevention and Control Board of Scientific Counselors. Published on July 18, 2021. See https://www.linkedin.com/pulse/comments-july-16-2021-meeting-us-cdc-national-center-injury-lawhern/?trackingId=UDFjJsc3SYazTQYxt78y3g%3D%3D.

57. Stewart TL. Let me get this straight… P3Alliance speaks on Chou’s COI during Public comment. July 16, 2021. See https://www.youtube.com/watch?v=DndVrnlc0y0.

58. Anson P. CDC Advisory Panel Warns Revised Guideline Ignores Benefits of Opioids. Pain News Network, July 16, 2021. See https://www-painnewsnetwork-org.cdn.ampproject.org/c/s/www.painnewsnetwork.org/stories/2021/7/16/advisory-panel-warns-cdc-revised-opioid-guideline-ignores-risk-of-undertreating-pain.

59. Kollas CD. Personal observation at 10 AM from the Roll Call of the CDC BSC-NPIPC Meeting on July 29, 2021.

60. Darnall BD, et al (including Kollas CD). International Stakeholder Community of Pain Experts and Leaders Call for an Urgent Action on Forced Opioid Tapering. Pain Medicine, 2018; 0:1-4. See https://pubmed.ncbi.nlm.nih.gov/30496540/.

61. See Resolution 235 at https://www.ama-assn.org/system/files/2018-11/i18-refcomm-b-annotated.pdf.

62. Health Professionals for Patients in Pain (HP3), led by Alford DP (and including Kollas CD). Professionals Call on the CDC to Address Misapplication of its Guideline on Opioids for Chronic Pain through Public Clarification and Impact Evaluation. March 6, 2019. See https://healthprofessionalsforpatientsinpain.org/the-letter-1.

63. Carlson RW, et al. Letter to Deborah Dowell, Chief Medical Officer, Opioid Response Coordinating Unit, CDC National Center for Injury Prevention and Control. February 13, 2019. See https://www.asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/2019-NCCN-ASCO-ASH-Letter-CDC.pdf.

64. Nicholson KM, Hoffman DE, Kollas CD. Overzealous use of the CDC’s opioid prescribing guideline is harming pain patients. Stat News, December 6, 2018. See https://www.statnews.com/2018/12/06/overzealous-use-cdc-opioid-prescribing-guideline/.

65. FDA Drug Safety Communications. FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering. April 9, 2019. See https://www.fda.gov/media/122935/download.

66. FDA Drug Safety Podcast. FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering. April 17, 2019. See https://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes#:~:text=On%20April%209%2C%202019%20FDA,%2C%20psychological%20distress%2C%20and%20suicide.

67. CDC Media Relations. CDC Advises Against Misapplication of the Guideline for Prescribing Opioids for Chronic Pain. Embargoed Until: Wednesday, April 24, 2019, 5 PM, EDT. See https://www.cdc.gov/media/releases/2019/s0424-advises-misapplication-guideline-prescribing-opioids.html.

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71. Kertesz SG, Manhapra A, Gordon AJ. Nonconsensual Dose Reduction Mandates are Not Justified Clinically or Ethically: An Analysis. J Law Med Ethics. 2020 Jun;48(2):259-267. doi: 10.1177/1073110520935337. PMID: 32631183; PMCID: PMC7938366.

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78. See https://www.cdc.gov/opioids/data/analysis-resources.html.

79. Mukkamala B. AMA Letter to Gwendolyn H. Cattledge, PhD, MSEH, Deputy Associate Director for Science, National Center for Injury Prevention and Control Centers for Disease Control and Prevention. July 22, 2021. See https://searchlf.ama-assn.org/letter/documentDownload?uri=%2Funstructured%2Fbinary%2Fletter%2FLETTERS%2F2021-7-22-Letter-to-Cattledge-re-CDC-BSC-Comments-final.pdf.

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82. Anson P. Revised CDC Opioid Guideline Not Expected Until Late 2022. Pain News Network, July 9, 2021. See https://www.painnewsnetwork.org/stories/2021/7/9/revised-cdc-opioid-guideline-not-expected-until-late-2022.



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