Inclusion Check-in: Are Integrative Practices in New Federal Opioid Legislation, National Academy, and FDA Activity?

Inclusion Check-in: Are Integrative Practices in New Federal Opioid Legislation, National Academy, and FDA Activity?

One can easily count the chickens of non-pharmacological approaches highlighted in multiple organizational guidelines and state strategies related to pain and opioids. But one definitely cannot count on them hatching inside each new, significant policy initiative. Regular medicine tends to regress toward a non-inclusive mean in pain treatment. And “mean” may be the operative word – at least from the perspective of individuals who remain unaware of the integrative therapies and practitioners that may help them.

This is an irregular Integrator look at the level of inclusion in recent major initiatives related to pain and opioids. To start, the federal opioid legislation – then two from the National Academy of Medicine and late breaking from the FDA.

The Opioid Crisis Response Act of 2018: (Virtually) No Mention in the Senate Version
On September 10, 2018, the US Senate HELP Committee published a 3.5 page executive summary of the version it passed of the Opioid Crisis Response Act of 2018. The Senate promoted its version of the legislation as the result of 6 bipartisan hearings involving an alphabet soup of federal agencies (FDA, NIH, CDC, SAMHSA) plus governors, pain experts, and individuals caught in the crisis of unbalanced chronic pain management. The very first charge, for instance, is to the NIH to find a new, non-addictive pain-killer. That sets the tone. It is not altogether a surprise that the 7 sections and 29 sub-sections of the summary do not include any explicit mention of “complementary” or “integrative” modalities or practitioners. What would be shocking if we were not de-sensitized by the expectation of pro-pharma pandering of Congress is that the term “non-pharmacologic” didn’t make the HELP memo at all. This is despite their elevation in multiple recent pain-related recommendations (see examples in this article and again here).
A separate 18-page memo with a section-by-section analysis of the mammoth piece of legislation, also from the US Senate, offers two very limited specific mention that might please a street beggar:
  • Section 1202 on “Pain Research” suggests “including information on best practices for the utilization of non-pharmacologic treatments.”
  • Section 1502 on Programs for Health Care Workforce “updates pain care programs to include alternatives to opioid pain treatment and by promoting non-addictive and non-opioid pain treatments, and non-pharmacologic treatment.”

Some others brush up against the field, or mention it negatively:

  • Section 1301 on “Clarifying FDA Regulations for Non-Addictive and Non-Opioid Products” focuses mainly on drug solutions but potentially pushes a door ajar.
  • Section 4203 on “Opioid Addiction Recovery Fraud Protection” includes “supplements” as possible agents that may be used with fraudulent promises.
One hopeful sign is a section related to the Substance Abuse and Mental Health Services Administration. This includes a call for Comprehensive Opioid Recovery Centers that are meant to “provide the full continuum of treatment for patients in areas hit hardest by the opioid crisis, this would authorize a grant program for entities to establish or operate a comprehensive opioid recovery center and would require centers to serve as a resource for the community.” Multiple efforts to support mental health and behavioral health services are referenced – which are good steps beyond pharma – including a program to allow masters level, licensed substance use disorder treatment counselors to receive loan repayment for practicing in underserved areas. Nothing on non-pharma approaches.
A September 18, 2018 article in Fortune on the surprising level of bipartisanship backing the bill notes that the work plan is incomplete: “All parties involved do seem to agree on one thing: Whatever form of the opioid bill that reaches President Trump’s desk will just be the next step in fighting the public health scourge, not the last word.” Apparently, even in this time of frightening political polarization, Republicans and Democrats can find common ground more readily than can pharma and non-pharma interests. (Note that I have not read the entire bill and am relying for this reporting on these 2 summaries. The bill has not yet become law but is expected to do so in more-or-less this form.)

National Academy of Medicine #1: Opioid Action Collaborative

On July 31, 2018, the National Academy of Medicine announced that it was launching an “Action Collaborative to Counter Opioid Epidemic – Public-Private Partnership Will Coordinate Initiatives Across Sectors to Drive Collective Solutions.” On the NAM website for the initiative the title is: “Countering the Opioid Epidemic: NAM Action Collaborative.”

The steering committee consists of 5 medical doctors, a PhD and an attorney. There is hardly a whisper of the interprofessionalism that, under the predecessor of current NAM president Victor Dzau, MD, another part of NAM is promoting. The inclusion of Ruth Katz, JD, MPH, one of two women among the 7 and the vice president and executive director for the Health, Medicine and Society Program at the Aspen Institute, appears to be a possible open door. However, that group’s 5-“big ideas” for resolving the crisis in The Hill – co-signed by former HHS secretaries Kathleen Sibelius and Tommy Thompson – only went so far as to mention the importance of behavioral and mental health. No non-pharma beyond this.

The Opioid Action Collaborative’s list of “Participating Organizations” also puts NAM out of step with era of interprofessionalism that is a hallmark of value-based medicine and achieving the Quadruple Aim. The NAM circle opens beyond MDs only to include the American Association of Colleges of Pharmacy, and dentists. Nursing is not even represented, nor social work, nor major organizations representing behavioral and mental health. The accepted membership of the patrician 1950s dominates. No surprise then that profession linked to the licensed integrative medicine fields or acupuncture and chiropractic and Yoga and mindfulness and the other methods many citizens are using to limit drug dependence were not invited to the table.

Action: In this instance, I directly contacted NAM staff to see if this was one of NAM’s “pay to play” initiatives. If so, an integrative health organization such as the Consortium or the Collaborative might hustle up the money to insure that individuals skilled in integrative pain care were at the table. (There is precedent: the Academic Collaborative for Integrative Health (“The Collaborative”) paying dues for the past seven years, through a philanthropic gift, to participate in the NAM Global Forum on Innovation in Health Professional Education. See segment below and Widening the Circle: ACCAHC Report from the 1st IOM Global Forum on Interprofessional Education .) The response I received now two months ago was that the NAM initiative was not organized in this methods and such a door was not open. I urged that NAM place someone with expertise in the dialogue onto the steering committee or in a consulting role. This led to some interest, even openness to one of the professionals who could represent multiple integrative professions who I suggested. As of today, the individual has reportedly been approached but no position secured.

Bottom line: medicine’s regression to its comfort zone of a reductive, mono-professional mean is apparently continuing in full force.

National Academy of Medicine #2: Cherkin/Delitto Co-Chair Non-Pharma Approaches to Pain Management Workshop

This additional NAM initiative, while more limited and lower profile, is much better news. On December 4-5, 2018, the NAM Global Forum on Innovation in Health Professional Education announced that it is co-hosting a workshop entitled The Role of Non-pharmacological Approaches to Pain Management. The Global Forum, under the direction of Patricia Cuff, began as a profoundly interprofessional engagement. Integrative fields have been represented, as noted above, through the Academic Collaborative for Integrative Health. The Global Forum is co-sponsoring the workshop with the National Academies’ Forum on Neuroscience and Nervous System Disorders,

Co-chairing the upcoming workshop are Daniel Cherkin, PhD from Kaiser Permanente and Anthony Delitto, PhD, PT from University of Pittsburg. Cherkin is a well-known researcher in complementary and integrative practices for back pain. He has served as the program director for the major research meeting of the Academic Consortium for Integrative Medicine and Health (The Consortium), and, briefly, on the Research Working Group of the Collaborative. Delitto has a history of collaborative research at U Pitt, with chiropractor Michael Schneider, DC, PhD  and others in his rehabilitation department.

The two paragraphs introducing the purpose of the workshop note a 2011 NAM document that the Collaborative influenced. In 2010, the organization successfully nominated acupuncturist and naturopathic doctor Rick Marinelli, ND, LAc, the former president of what is now the Academy of Integrative Pain Management, to serve on the Committee that produced the report on Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. That document, as the workshop’s statement notes, “advocated for multifaceted approaches for pain management comprised of both pharmacological and nonpharmacological therapies. (The integrative language from the 2011 Blueprint is compiled here.)

The website for the upcoming workshop does not presently include a list of the committee members who typically guide such processes. I have heard via the grapevine that Elizabeth Goldblatt, PhD, MPA/HA, who serves as the Collaborative’s member on the Global Forum, is serving on this group. While it is good news to have a representative from the licensed integrative healthcare fields represented, and Goldblatt has a history of networking with key players in the integrative health and medicine space, she hasn’t the depth of clinical or research familiarity that Marinelli and others in the field have. Hopefully, the committee will include subject matter experts from the integrative practice fields and Goldblatt will have an opportunity to connect the committee with others who live, eat and breath the integrative pain environment. .

Meantime, the introductory language for the workshop notes that it will “bring together key stakeholders to discuss these treatments and integrative health models for pain management.”  The objectives are excellent, and leave this review on a hopeful note:

Workshop Objectives:

  • Review the current state of evidence on the effectiveness of nonpharmacological treatments and integrative health models for pain management, as well as available evidence on use patterns and patient interest. Examples may include acupuncture, manual therapies, physical therapy and exercise, cognitive behavioral therapy, tai chi, yoga, meditation, and neurostimulation.

  • Consider multimodal approaches and potential synergies between pharmacological and nonpharmacological approaches to pain management.

  • Consider multimodal approaches and potential synergies between devices and nonpharmacological approaches to pain management.

  • Discuss research gaps and key questions for further research.

  • Examine health professions’ current approaches for educating students, trainees, and practicing clinicians on nonpharmacological pain management, and discuss potential next steps to improve training and education within and across health professions.

  • Explore policies, such as those related to reimbursement, that would enable broader dissemination and implementation of evidence-based nonpharmacological treatments when appropriate.

Cherkin and Delitto can draw on a broad network of complementary and integrative experts if they chose. A minor concern is with a reductive decision that Cherkin’s former employer Group Health Research Institute made in 2010 when its prescient paper on the opioid crisis made no mention of any value from complementary and integrative strategies. This stemmed apparently from a decision to only examine research that specifically looked at complementary and integrative methods for people on opioids – there were then very few – rather the considering the problem in the broader context of the nation’s failure to appropriately utilize all possible resources in a chronic pain strategy. The workshop objectives, and language, suggest a broader framework.

Late-Breaking: FDA’s Opioid Risk Evaluation and Mitigation Strategy Includes Non-Pharma

As I was completing this check-in on inclusion, I received some good news from Bob Twillman, PhD, executive director of the Academy of Integrative Pain Management (AIPM). The FDA Opioid Analgesic Risk Evaluation and Mitigation Strategy was announced September 18, 2018 and included significant evidence of inclusion of non-pharmacologic approaches -with direct mention of “complementary therapies.” An evaluation from AIPM’s director of legislative and regulatory affairs, Katie Duensing, JD, notes the following:

  • Education A section on education of health care practitioners (HCPs) suggests that preparation for practice should include “the range of therapeutic options for managing pain, including nonpharmacologic approaches and pharmacologic (non-opioid and opioid analgesics) therapies.”
  • Coverage “If HCPs encounter potential barriers to managing patients with pharmacologic and/or nonpharmacologic treatment options, such as lack of insurance coverage or inadequate availability of certain HCPs who treat patients with pain, attempts should be made to address these barriers.”
  • General Principles of Non-Pharmacologic Approaches  Duensing share this explanatory text from the document: “Pain can arise from a wide variety of causes. There are a number of nonpharmacologic and self-management treatment options that have been found to be effective alone or as part of comprehensive pain management plan, particularly for musculoskeletal pain and chronic pain. Examples include, but are not limited to, psychological, physical rehabilitative, and surgical approaches, complementary therapies, and use of approved/cleared medical devices for pain management. HCPs should be knowledgeable about the range of treatment options available, the types of pain that may be responsive to those options, and when they should be used as part of a multidisciplinary approach to pain management. HCPs should also be aware that not all nonpharmacologic options have the same strength of evidence to support their utility in the management of pain, and some may be more applicable for some conditions than others.”

Twillman notes that this list is not inclusive. In themselves, these are good steps from an FDA that many in the alternative-complementary-integrative zone would assume – by their own biases – would be the last federal agency to promote broader education about, and use of, non-pharma approaches. The FDA’s 42-page strategy teaches that it serves none of us to regress to a pre-integrative, polarized mean.

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