Draft Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations – PPM Editorial – Authors of this commentary are: Richard A Lawhern, PhD and Stephen E Nadeau, MD – Feb 2019
Here is a great example of an excellent commentary on the Draft Report from the HHS. We can all use this as a template for how to organize our own comments.
The following review comments were submitted in response to the draft report, Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations, published by the HHS Pain Management Best Practices Inter-Agency Task Force.
To Be Praised
I urge everyone to start with the positive to make our later criticism more palatable. We have to remember the person reading our comments and try to be what they would regard as “reasonable”. Otherwise, I fear our commentary will be left unread and disregarded.
There is much to praise in the Task Force’s draft recommendations, including their:
- recognition of the vast scale of the chronic pain problem;
- emphasis on patient quality of life rather than just optimization of function;
- highlighting of the negative effects of patient stigmatization; and
- recognition that there is no one-size-fits-all patient or therapy plan.
The emphasis on increasing the number of well-qualified pain practitioners recognizes the severe inadequacy of our current pain treatment infrastructure.
The recommendation that urine testing must never be used as a basis for firing patients is most welcome.
This is something we can all praise without reservation.
I had not noticed this point in my reading and commenting, which I laid out in three blog posts:
- HHS Report on Pain Mgmt Best Practices – part 1
- HHS Report on Pain Mgmt Best Practices – part 2
- HHS Report on Pain Mgmt Best Practices – part 3
To Be Challenged
However, there are also significant areas where corrections and redirection are particularly needed.
Failure to take action at this time may leave in place processes likely to both perpetuate harmful effects on patients in pain and inhibit a shift in public policy focus to the heart of the opioid crisis: users of illicit drugs.
For me these are the primary issues:
Get law enforcement out of our pain management!
Stop treating all pain patients on opioid therapy
like we are suffering from addiction.
Stop minimizing the severity of our pain and
undervaluing the relief we get from opioids.
Stop standardizing the opioid doses we need
to treat the multiple aspects of our pain.
The CDC guideline is fatally flawed in process and content, and it is actively dangerous to patient health and physician practice on multiple grounds.
For instance, the guideline reflects:
- an overestimation of the role of medically managed opioids in addiction and opioid mortality4,5
- a broad and unacknowledged anti-opioid bias that is unsupported by science and current practice
- a naïve declaration that opioids are ineffective for long-term treatment6 (clinical trial evidence has successfully circumvented the challenges of conducting opioid trials and demonstrates major benefit)
- an equally naïve declaration that non-opioid therapies are available and “preferable” for treatment of chronic pain, despite the complete absence of comparative effectiveness studies, thereby opening the door to mandated substitution for analgesic therapy7
- a failure to recognize and embrace the inherent genetic variability of opioid metabolism between individuals, which provides the basis for a 15-fold variability in effective dosage.
This is a “nice” way of saying their research and statistics were heavily biased. (see https://edsinfo.wordpress.com/tag/research-bias/)
The draft recommendations appropriately cite the Dasgupta, et al, study, but fail to reference two important papers that also demonstrate the low case fatality rates associated with opioids in the treatment of chronic nonmalignant pain, even when prescribed in substantial dose (0.25% – 0.5% per year).
These are Gomes, et al, and Bohnert, et al, which demonstrate that intended risks of opioid-related mortality are comparable to those experienced by patients treated with rivaroxaban or warfarin, respectively, for prophylaxis of stroke due to atrial fibrillation
Such risks seem almost certain to be acceptable to most patients with moderate to severe chronic pain.
Large studies of post-surgical patients treated with opioids for pain reveal that medical exposure to opioids incurs a less than 0.6% risk of alleged opioid use disorder (OUD) in opioid-naïve patients
The incidence of sustained prescribed opioid therapy after common surgical procedures is less than 6%, plausibly reflecting not medication misuse, but rather, the emergence of chronic post-procedural pain.
The American Medical Association has publicly rejected the CDC guideline as a basis for either mandated prescribing limits or sanctions against healthcare providers for “over-prescribing.”
The OUD Factor
Repeated emphasis on OUD in the Task Force’s draft recommendations fosters the idea that there is high risk of this disorder in patients with chronic pain treated chronically with opioids.
Though a great improvement over the CDC guideline, this document is still much more concerned with opioid misuse than appropriate opioid use for the relief of intractable pain.
The scientific evidence shows that the risk of OUD is very low, certainly less than 3% in the authors’ judgment, and probably much lower.
Perpetuation of this myth of high risk may inhibit prescribers from initiating opioid therapy and titrating properly. Implicitly linking prescription opioids to OUD will further incentivize efforts to deal with the opioid crisis by limiting prescriptions rather than effectively managing the complex problems of illicit drug use.
This is the continuing problem with all policies and reports: they see our prescribed opioids as being the cause of the “opioid crisis” even though the real problem is from illicit drugs.
Also problematic is an unproven assumption presented in the draft report that the combination of opioids with benzodiazepines is inherently dangerous.
In the meantime, the pain management community lack good alternatives for treatment of comorbid anxiety, insomnia, and pain due to muscle tension and spasm, even as such treatment may be instrumental to achieving control of pain and reducing opioid dosage.
As someone who suffers from periods of crippling anxiety, I sometimes feel like the impact of this on me will be deadly. I’m gripped by a nameless terror, paralyzed by a malignant fear of the future, incapable of escape, and facing certain doom, yet I’m not allowed the medication (a benzodiazepine) that would ease this overwhelming misery.
This sort of generalized anxiety is another biological consequence of my genetic condition, Ehlers-Danlos Syndrome. I have a genetic component that manifests as depression/anxiety and no amount of therapy and “understanding it’s not real” has been able to ease it.
But, when I have to fear the loss of my only effective pain relief, forced to live in the misery of biochemical anxiety spells, already disabled from being able to earn a living, perhaps my fears are perfectly reasonable.
In these circumstances, I cannot even make a cognitive argument against my fears because they are really happening in my “real life”.
There is a major emphasis in Task Force’s draft recommendations on the use of
- anti-inflammatory medications,
- tricyclic antidepressants,
- various alternative therapies,
- “restorative” therapies, and
- behavioral health approaches
to managing chronic pain, despite the absence of comparative effectiveness studies supporting these approaches.
Further, there are even fewer studies demonstrating the effectiveness of these therapies in enabling reduction of opioid dosage. To date, no alternative therapy has been vetted by a Phase III trial.
The paper by Krebs, et al., in the authors’ opinion was flawed by a failure to include participants representative of the population of patients with moderate to severe chronic pain and a failure to adequately titrate opioid dosage.
However, its repeated reference in the draft recommendations perpetuates the myth that opioids are not effective in treating chronic pain. There is strong countervailing scientific evidence.
Overall, a correction is needed in the Task Force’s current emphasis on the management of presumed but un-demonstrated risks of opioid therapy.
In many acute and chronic disorders, and for the great majority of patients, opioids are safe and almost uniquely effective in pain management.
To argue for mandated withdrawal of such therapy in the absence of proven alternatives is fundamentally irresponsible.
Yes, that’s a good way to address the focus on taking away opioids when there are no effective alternatives.
Detailed analysis of data published by the CDC itself demonstrates that rates of opioid-related mortality from all sources (ie, legal, diverted, and illegal) are unrelated to rates of prescription by doctors.
It also demonstrates that patient demographics on chronic pain and addiction are largely disjoint, with the highest rates of overdose mortality occurring in youthful populations that receive the fewest prescriptions.
This is becoming glaringly obvious, yet this truth remains submerged under the storm of PROPaganda pushed by most media outlets.