HHS Report Feedback: Recommendations

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:

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.

Data Mishaps

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.

Co-Prescribing

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”.

Comparative Studies

There is a major emphasis in Task Force’s draft recommendations on the use of

  • anti-inflammatory medications,
  • tricyclic antidepressants,
  • anticonvulsants,
  • 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.

Total Understanding

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.

See also:

7 thoughts on “HHS Report Feedback: Recommendations

  1. david

    Hello Zyp. Tragically the PMTF are, from my perspective, more of the same expertcentric, underpowered, top down visionless pain managerialism with no call for cures, prejudice against regenerative medicine, and fail to call for moral, social ,political, and legal progress in pain care. The PMTF relegated people in pain to “commenters” thereby reflecting their snobbish autocratic antidemocratic stance on pain care. Needless to say the experts on the PMTF werent trained to deal with doubt, democracy, dissent and differences- and it shows. Each one of the PMTF members should have called foul when they knew there was inadequate policy representation for people in pain. They clearly wanted the resume builders and are too morally anesthetized to consider procedural justice for people in pain.
    Make yourselves sheep and wolves will eat you as Benjamin Franklin wrote. No doubt, the PMTF and pain managers and government want docile sheep and not citizens in pain who are active and vigilant and believe in justice, democracy and individualism.
    Morally anesthethized market fundamentalism, social darwinism, narciccissm, visionless expertcentrism characterize the PMTF members and their recommendations. I challenge any of them to debate me and prove me wrong. But since they re just morally anesthetized technocapitists with little or no education in moralit, vision, social emotional intelligence- I think they would only embarass themselves to debate yours truly.

    Liked by 2 people

    Reply
  2. Jan Poole

    Dear Zyp,
    This ranks up there with Dr. Richard Lawhern’s review and recommendations on the HHS Report in terms of the insight, depth of analysis, encouragement, warmth of love and compassion for the pain community it was written for!!!! What a masterpiece!!

    It’s given me new things to consider in my own comments, and to reconsider or rephrase in a more in in a more positive way. Thanks again Zyp, you have many wonderful gifts, love, compassion, analytic mind, kindness, thoughtfulness and many more!!! I wish I could help you with your anxiety! It’s terrible to have to deal with that! There is a peace that only God can give you. If you haven’t tried it, read the gospel of John.

    Liked by 1 person

    Reply
    1. Zyp Czyk Post author

      Wow, your praises really warm my heart!

      I’ve been struggling so much with my my mood lately that I was almost going to take a break from blogging – and run the risk of never getting started again. So, I just wrote it out, thinking that personal experiences might make the best, most impactful comments.

      Liked by 1 person

      Reply
  3. Gregg Kervill

    Hello Again and my apologies IF my offended any innocent party yesterday. Today my pain level is under better control!

    Please let me share 30+ years of experience in creating complex suites of documents and map out a solution to the “Illegal and Legal Drug Crisis” from which we are all suffering, physically, emotionally or in some other way

    The problem with the guidelines, the Draft PLAN and CARA documentation is they all lack clarity and STRUCTURE.
    That is why there are so many differing comments and recommendations for inclusion, deletion or changes.

    I have 30 years+ experience in creating COMPLEX Operational Policies, Plans and Procedures (which I often refer to as the 3P’s or a Documentation Matrix). Several of these exceeded a thousand pages, but offer a simple structure, and clarity for those that used them.
    The “Illegal-Legal Drug” Crisis requires a Three Tier Documentation solution.
    It will never be solved by a ‘flat’ Simple document is (as demonstrated by The Report) and will be IMPOSSIBLE to manage or to change.

    Hence we need to return to the Status Quo Ante (and stop forcing patients to commit suicide) whilst the POLICIES, PLANS AND PROCEDURES are created.

    THE POLICY must first be WRITTEN, AGREED and AUTHORIZED. Only THEN can THE PLAN begin.
    To write PROCESSES or PLANS before a POLICY is authorized will result in much wasted time money and other wasted resources plus huge frustration among those involved.
    That said, it is reasonable to begin creating a GENERIC structure (Boiler-Plates) for PLANS and PROCEDURES, and it is also reasonable to create some of the GENERIC sections to these documents (Examples – Authority of Document – Change Control of this Document , Enforcement…..)

    The following is my recommended Structure and Description of THREE levels of Documents. (It is EXTREMELY WISE to use a common boilerplate that is the same for to ALL documents, and is agreed by all parties and authorities. If a section is not required merely keep the heading and add a note that “This section is intentionally left blank”. This will make huge saving when editing and referencing between documents):
    FIRST THE POLICY
    Example – “APPROVED OPIOID and ILLEGAL DRUGS POLICY:”
    This should be a 5 to 10 page document (NO MORE THAN 10). THE POLICY establishes the SCOPE and GENERAL intent; it does not include any detail. Keeping this document small is the key and will force the writers to use every word carefully; maximizing clarity and minimising ambiguity.
    Example “SCOPE:
    “This POLICY applies to all legal and illegal drugs and their users.
    It will identify over-the-counter, and prescription medication shall be controlled; the authorization of prescriptions; and Dispensing of Controlled Drugs
    This POLICY defines how those addicted to legal and illegal drugs shall be defined, and their treatment managed.
    This Policy recognizes that some Addicts will fail to respond to treatment – management of these individuals shall be DEFINED by Federal documents #Ref-included, and by individual State regulation as detailed in ANNEX A – List of State Treatment and Management of Addicts.
    Example: “CLASSIFICATION OF PATIENTS:”
    This POLICY define how Patients shall be Classified and Characterized, and their treatment managed: (examples)
    1. ADDICTS requiring short term (less than 10 days) intervention or treatment: shall be defined and reference in #Ref Treatment Plans (#xxxxx)
    2. ADDICTS requiring medium term (less than 31 days) intervention or treatment: how they are defined and reference in #Ref Treatment Plans (#xxxxx)
    3. PATIENTS with SHORT-TERM PAIN: – post operative and similar……. in #Ref Treatment Plans (#xxxxx)
    4. PATIENTS with INTERMEDIATE PAIN: how classified and how treated, and in Contract (#Ref) between Patient and Doctor and in #Ref Treatment Plans (#xxxxx)
    5. PATIENTS REQUIRING LONG-TERM PAIN TREATMENT…… in #Ref Treatment Plans (#xxxxx).
    6. PATIENTS REQUIRING DURATION OF LIFE PAIN TREATMENT; Classification primarily Seniors for whom surgical treatment and other interventions has been exhausted or not cost effective. in #Ref Treatment Plans (#xxxxx).
    7. PATIENTS REQUIRING END OF LIFE PAIN TREATMENT – classification –
    8. PATIENTS REQUIRING TERMINAL AND END OF LIFE PAIN TREATMENT – primarily Cancer and other terminal illness in #Ref Treatment Plans (#xxxxx) and (#xxxxx).
    9. Etc…..
    Example – POLICY AUTHORIZATION AND CHANGE CONTROL PROCESS
    This POLICY is issued and authorized by (name, titles, organization, tel, email)
    If additional classification are required or if changes to this document are required POLICY Change Requests should be completed in accordance to #REF found at url www……
    [EXPLANATION #1 – The reason for including a detail list of ALL classifications and categories is so that ANY or EACH category can be managed or changed WITHOUT disturbing the treatment of other patient groups or categories.]
    [Explanation #2 – each patent category ends with reference to the PLAN or PLANS by which each group is to be managed.]
    [Explanation #3 – THE POLICY Document should be kept small but should allow common treatment planning to be used wherever possible. The RISK is that if each category is developed in isolation the administrative burden (including THE PLANS and Legislative burden) will grow like Topsy!]

    Next we write THE PLAN
    Example “THE OPIOID and ILLEGAL DRUGS PLAN”
    There is usually only ONE PLAN for each category. This document should be less than 50 pages. It is written as a response to one top level POLICY DOCUMENT. (If one protocol can use used for several “Groups” then each PLAN shall be given a unique reference and correspond to each Group, the content of each PLAN is pasted into each, uniquely identified Group. (This will allow for each to be modified at some future date.)
    THE PLAN lists and describes a hierarchy of published Federal and State Plans that address each of the policy items identified in the POLICY.
    [IMPORTANT – Plans only respond to the POLICY – they do not introduce new requirements.]
    [If a new policy is to be created it requires a change to the POLICY document and will “flow-down” via PLANS to PROCESSES. This prevents dubious or “on-the-fly” changes being introduces without the POLICY Authors being aware, and agreeing to additions.]

    Finally we create THE PROCESSES – these

    “THE OPIOID and ILLEGAL DRUGS for ADDICTS requiring short term intervention” (#Ref)
    SCOPE this PROCESS is specifically for ADDICTS requiring medium term (less than 31 days) intervention or treatment.
    Definition of Patent Group:

    Include Detail Treatment using the Boiler Plate or template structure.
    If a section is not relevant then the heading is retained and a note “This section is deliberately left blank” This will save time in the future (if the content become necessary – and when cross-referencing between documents).

    (COMMENT
    • This structure may seem restrictive but if the task is not managed correctly the cost and timelines over-runs will be uncontrollable. (For comparison with a CORPORATE Quality – Development – Reliability Growth and other detailed supporting documentation, would take about 8 months to complete. Depending upon how many detailed PROCESSES are available and can be used, without major changes it should not take much longer to complete and issue this type of documentation matrix.)
    • If we step back and regard the finished Documentation Suite to be a Jig-Saw – and THE PROCESSES to be the pieces of that Jig-Saw.
    Writing, Agreeing and Authorizing THE POLICY and THE PLAN will enable those involved to identify the Federal and State documents that can be used as Pieces necessary to complete the final Jig-Saw.
    Without creating THE POLICY and THE PLAN it will be EXTREMELY difficult to identify what existing documents can be reused.
    • Creating Boiler-Plate formats for THE PROCESSES will make it easier (and MUCH CHEAPER) to complete the final documentation matrix.

    Perhaps this will help. EVEN IF IT REQUIRES A LOT OF RE-WRITING AT THE START.
    And By The Way – I have received huge (thousand page) document ‘dumps’ from former clients that needed Corporate Documentation created.
    The most effective way I found of creating Logical, Useable and Controllable outputs was to use the 3P’s (Policies, Plans and Procedures) structure.
    My first step was always to agree THE POLICY – and get sign-off
    The next step was to agree THE PLAN – and obtain sign-off.
    After that is was a simple, straight forward task (just time consuming) of fitting the “Pieces” together. Importing a common format, and structure (Boilerplate). Final sign-off was then not a big deal because all levels and content had been approved; and expectations had been set and agreed before completion of the job.
    Best regards

    Gregg

    Gregg Kervill DipIM MIIM SMIEEE NCE ICC KK4UEU
    #1 International Amazon Bestselling Author http://www.tinyurl.com/LNqq44u

    Liked by 1 person

    Reply
  4. GZB

    PROPaganda!! :))
    Thanks, great article, again. You’ve really helped to clarify this report that is in sore need of clarification. I will definitely use your suggestions as I draft my response. P.S., please don’t go away!

    Liked by 1 person

    Reply
    1. Zyp Czyk Post author

      And I thank ATIP and Red Lawhern for collecting all this information/data that we can brandish as weapons against anti-opioid zealotry in all its forms. We just have to keep repeating the truth.

      Like

      Reply

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