IPRCC Meeting - June 7, 2022

National Institutes of Health

Conference Call

2:00pm to 5:00pm

Federal Register Notice

IPRCC June 7, 2022

2:00 PM- 4:30 PM ET

2:00 PM Welcome, Introductions and Highlights

Dr. Koroshetz, Chair IPRCC

2:30 PM Business Items

Dr. Linda Porter, DFO IPRCC

Approval of the Meeting Minutes from November 2021 IPRCC Meeting

  • Vote for Chair of the Committee
    • Call for nominations
    • Call for vote

2:50 PM Federal Updates

Elizabeth Kato, AHRQ Representative to IPRCC

3:00 PM Clinical Pain Research Workforce Enhancement

Moderator:  Dan Carr, Retired IPRCC Member

  • Linda Porter: the NIH perspective (5 mins)
  • Laura Wandner, Program Director NINDS: overview of K24 and K12 programs (5 mins)
    • American Academy of Physiatry- (speaker TBD) example of success (10 mins)
    • Anesthesiology - Christine Sang (10 min)
    • Moderated discussion of workforce needs/challenges

3:50 PM    Opioid Work Group perspective on the revised CDC Guideline for Opioid Prescribing

Beth Darnall, IPRCC representative and Opioid Workgroup member for Guideline

               Overview of the revisions

               Discussion

4:20 PM wrap up and adjourn

Interagency Pain Research Coordinating Committee

June 7, 2022

Virtual Meeting

On June 7, 2021, at 2:00 p.m., the Interagency Pain Research Coordinating Committee (IPRCC) convened for a virtual meeting. In accordance with Public Law 92-463, the meeting was open to the public. Walter Koroshetz, MD, Director of the National Institute of Neurological Disorders and Stroke (NINDS) presided as chair

The following IPRCC members were in attendance:

  • Federal Members: Elisabeth Kato, MD; Walter Koroshetz, MD; Rigoberto Roca, MD; Friedhelm Sandbrink, MD
  • Scientific Members: Beth Darnall, PhD; Christine Goertz, DC, PhD; Christine Nai-Mei Sang, MD, MPH; David A. Williams, PhD; Todd Vanderah, PhD
  • Public Members: Jim Broatch; Maggie Buckley; Julie Eller; Sue Pinkham; Irma Rodriguez
  • Ex-Officio Members: Rena D’Souza, DDS, PhD; Helene Langevin, MD
  • Designated Federal Official: Linda L. Porter, PhD

Welcome and Introductions –
Walter Koroshetz, MD, Director, NINDS ,
Linda Porter, PhD, Director, Office of Pain Policy and Planning, NINDS

Dr. Koroshetz noted that the process of getting new members on the IPRCC is not simple, and that while waiting for the approval from HHS of six new member nominees, several members were invited to extend their terms until the new members can join: Irma Rodriguez, Christine Sang and Beth Darnall.  He congratulated those members who were pending approval at the last meeting but have since been made official: Todd Vanderah, Friedhelm Sandbrink, Maggie Buckley and Julie Eller.  Lynn Matallana had to withdraw her nomination because of her obligation to National Fibromyalgia Association and other ventures, but we hope to include her in the future.

He noted that the NIH HEAL Initiative has transformed pain research going into the future, providing funding that he hopes will be sustained, and by brining various NIH institutes and centers (ICs) closer together than ever before. He noted a new HEAL program on treating pain in people with co-occurring opioid-use disorder, a population he said is very difficult to treat. Challenges like that bring NIH ICs together in a way that they haven’t before.

Dr. Koroshetz cited the “REJOIN” program, which Dr. Langevin described. REJOIN is an outgrowth of programs focusing on research on myofascial pain and knowledge gaps about those tissues (muscle and connective tissue, or fascia) as pain generators. Applications are being reviewed for research to identify abnormalities among myofascial tissues that may lead to pain. For example, when someone has knee pain, we often think about knee articulation itself, but there are a lot of other tissues around the knee. We don’t know if the pain is coming from the joint, cartilage, or from other tissues, or if there is an interplay between the tissues. REJOIN seeks to look at basic, underlying innervation to better understand these tissues and systematically map them and look at how they alter in terms of aging, pathology and degeneration, and discover any abnormalities that may be reversible.

Dr. Koroshetz noted the temporomandibular joint and pain research being done by the National Institute for Dental and Craniofacial Research (NIDCR). Dr. Webster of NIDCR noted how pain is a major factor that leads people to seek dental care and that pain’s importance to dentistry makes the cross-NIH collaboration so important.

The discussion shifted to NIH’s efforts to enhance the pain research workforce, particularly within clinical research. Dr. Koroshetz described a new research opportunity that was inspired by a conversation at a previous IPRCC meeting, where the committee identified potential workforce shortages as a barrier to research and the need for more structured opportunities for early-stage investigators to learn from more experienced investigators. The new RFA would develop a coordinating center that can work across the country and coordinate pain researchers from different institutions and assist those scientists with career development.

Dr. Porter described a funding opportunity for research on coordinated care in pain, calling for investigations in health care systems that could utilize primary care as a focus and integrate it with specialties. She mentioned other opportunities that had recently closed related to health disparities in chronic pain patients. She said that there numerous opportunities coming for preclinical pain research, from both HEAL and individual NIH ICs.

Dr. Koroshetz noted that many funding opportunities cut across the NIH ICs that deal with pain and can contribute to develop a strong cadre of clinical researchers in the pain space, including the coordinating center and award for mid-career researchers to help support younger trainees.

Questions/comments

It was discussed whether HEAL would put forward more investigator-initiated research opportunities or whether it would continue to favor things like “Data Coordinating Centers”.

The NIH understand that for investigators, especially those from underserved institutions, that may not have a lot of support for grant submission on short deadlines – it can be hard for them to be competitive for grant applications that depend on a coordinating center. The NIH is considering options. For example, the myofascial pain initiative is using an award type known as R61/R33. These are phased awards. The initial part is a planning phase, with additional years of funding if milestones are met. Those don’t depend on a coordinating center, are less difficult to put together, and depends mostly on achieving milestones as pain criteria for transition. The R61/R33 allows people to do exploratory work for first two years and do things that are more high-risk, may not need to be quite so fleshed out as a full 5-year grant.  On the other hand, the PRISM program relies on help that comes from the coordinating center, and some studies are successfully transitioning because of the help they are getting from the coordinating center. So while they are a little bit more complex, there is a benefit to these larger structures. It was also noted that the recent health equity opportunity was as phased award for individual teams.

The group also discussed reviving a K award for senior investigators given the problem of senior scientists leaving the field. Anecdotal evidence from conversations with major researchers in pain suggests that many researchers are considering retirement and are concerned about the future of mentorship within the pain field. It was noted that this is particularly true in the migraine research and dental fields. It was noted that there are sub-specialties within pain research where the workforce is growing, such as in perioperative acute pain and the basic pain research field is not facing the same workforce challenges. The opioid crisis, and a potential reluctance to do research on opioids in favor of non-opioid options may be exacerbating the workforce challenges.

Business Items

Approval of Previous Meeting

IPRCC members voted to approve the minutes from the IPRCC’s previous meeting.

 

Election of IPRCC Chair
Linda Porter, PhD

The IPRCC chair is nominated and elected by IPRCC members and serves a three-year term. The first chair was Storey Landis, who served until 2015 when she retired from NIH. Dr. Koroshetz stepped in as acting chair that year and was formally nominated in late 2015 or early 2016. There is no term limit for chairperson, and every member is eligible to be nominated. Dr. Porter asked if anyone would like to step forward as a nominee or would like to nominate anybody.

Dr. Koroshetz nominated Dr. Langevin, and Dr. Langevin nominated Dr. Koroshetz. Each provided a few words about their vision for the IPRCC. Dr. Koroshetz said the IPRCC has been valuable in helping set where the NIH’s future pain research directions. He noted that he comes from a fairly standard medical background, with a focus on neuroscience, similar previous chair Dr. Landis, and there may be some reasons to have a chairperson with a different background. Dr. Langevin said she came from a similar internal medicine background, but as director of NCCIH she said the center views pain through non-pharmacological approaches and has a strategic plan that really stresses the importance of treating the whole person, that pain is a symptom and involves a complex set of biopsychosocial factors. She said that the HEAL Initiative has been a great example of how to handle research on the complexity of pain and that the IPRCC should make sure NIH is not missing important directions in pain research.

Members selected Dr. Langevin as the new chairperson. Her leadership will take effect in the next IPRCC meeting after her selection is relayed to the NIH director and HHS secretary. Dr. Koroshetz, who will stay on as a committee member, was thanked for his service.

Federal updates –
Elizabeth Kato, MD, MRP, Medical Officer at the Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality

Dr. Kato updated the committee on the systematic reviews of pain research being undertaken by the Agency for Healthcare Research and Quality. A systematic review on treatments for acute and chronic pain will be wrapping up this summer (2022); no additional studies are being added to the review and there are no plans for updates at this time. A “living” systematic review of research on cannabis and other plant-based treatments will continue to be updated through 2025. The review is being managed by the AHRQ’s evidence-based practice center that reviews new literature every few months and updates the review as appropriate. There are two reviews being conducted on clinical decision support (CDS) for pain management, including a review on clinician and patient-facing CDS apps for chronic pain management (publication in process) and a review on how to scale up interoperable EHRs for CDS in patient-centered chronic pain (results expected 2024). A review on the management of opioids for older adults in primary care is expected in 2023.

Rigoberto Roca, MD, Director, Division of Anesthesiology, Addiction Medicine and Pain Medicine, Office of Neuroscience, Office of New Drugs, Food and Drug Administration

Dr. Roca reported that there are no major updates from the Food and Drug Administration. He said that the agency is holding pre-investigational new drug (IND) application meetings and are always interested in having interactions with researchers early in the drug development stage so that they can ensure those wanting to do first-in-human trials have enough information to support their study protocols. He said the FDA is very open to communication with NIH ICs who are being contacted by new drug developers.

Jennifer Webster-Cyriaque, DDS, PhD,  Deputy Director, National Institute of Dental and Craniofacial Research

Dr. Webster mentioned that NIDCR has a new initiative focused on temporomandibular joint (TMJ) pain.

Clinical pain research workforce update and discussion
Linda Porter, PhD and  Laura Wandner, PhD, Office of Pain Policy and Planning, NIND

The IPRCC discussed an initiative that the NIH has launched to expand and enhance the clinical pain research workforce. There is an urgent need to bring people into the field and keep them in the field, given the numerous challenges that researchers face. We have previously provided updates on a survey that we sent out to clinical pain researchers in 2021, which asked questions about what resources they have had access to in their careers that would help them come into the field, stay in the field or drive them out of the field. While it wasn’t a fully representative survey, there were enough responses to give us an idea of what some of the crucial challenges are and some thoughts on where NIH could try to fill in some of those gaps. Some of the issues that we heard about included a lack of access over time to training and mentoring in the research arena, how to start in a research career, and access to funding to support protected time. Respondents also mentioned the complexity of managing two different careers and working in a clinical environment where you might not be able to prioritize conducting research.

Dr. Laura Wandner further described specific issues facing the clinical pain management research workforce pipeline and NIH efforts to address each issue:

  • Not enough early career researchers to replace those leaving the field and respond to the increase in pain RFAs.
    • In response, the NIH HEAL Initiative has released an RFA for a national K12 where early career pain researchers would receive enhance training, mentorship, guidance, salary support and protected time in order to support their first grant application to NIH. It is modeled after the national K12 awards for neurology and pediatric neurosurgery.
    • HEAL has also released training supplements for early-stage investigators and those who are new to research.
    • There are also efforts to increase the translational pain management workforce by having early and mid-career scientists apply to open K18 announcements for experience in translation at an industry lab, or academic or government research center performing therapeutic development activities.
  • Early career pain researchers need better access to mentors and more opportunities for collaboration with researchers across the pain spectrum.
    • HEAL is seeking applicants to establish a pain research coordinating center that would provide training and enhanced mentorship year round, establish an annual meeting for researchers to network and help facilitate communication between pain researcher across the preclinical, translational and clinical spectrum.
  • There are too few mentors to train the next generation of pain researchers.
    • HEAL-awarded grants to provide protected time for both mid- and late-stage HEAL investigators to provide mentoring.
  • A lack of diversity within the pain research workforce.
    • HEAL encouraged investigators to apply for NIH-wide supplements to increase diversity among the scientific workforce.  
  • Because of COVID, NIH officials weren’t travelling or getting to meet with potential applicants.
    • The NIH Pain Consortium has been hosting webinars instead to answer questions about grant mechanisms and provide tips and trips to applicants. Each webinar is posted on the Pain Consortium website.

Dr. Wandner said that she has been publicizing these efforts during conferences and webinars, and the feedback from the community has been positive.  The NIH workforce efforts are appreciated by the community and researchers would like us to continue releasing workforce RFAs. It may also be important to target people in grad school/medical school, fellowships, and post-docs so they can receive the training needed to apply for early career NIH awards.  

Perspective from physiatry community
John Whyte, MD, PhD, Association of Academic Physiatry  
 

Dr. John Whyte, a physiatrist and experimental psychologist and emeritus scientist at the Moss Rehabilitation Institute in Philadelphia provided details about efforts within the physiatry/rehabilitation field to grow the research workforce. When their efforts began, there were very few rigorously trained researchers, little research funding, and a lack of theory and methodology. There was a need for a deeper training in relevant domains of science, but few people with strong research backgrounds to provide mentorship for a someone on a research career trajectory. The field pursued an intervention involving mentored career development and felt it was important to provide mentors who could model successful funding and provide overarching guidance on how you put all of these pieces together as you move throughout a complex clinical research career, helping trainees find domains relevant to their research directions and help immerse them in a multidisciplinary milieu that modeled the kinds of research that interested them.

In 1995 the NIH began providing a K12 grant to support research by physiatrists, which ran until 2017, when it was turned into an R25 with similar support infrastructure, such as a research workshop for career development, small group meetings to review individual trainee goals and progress and set them up for independent research.

The R25-funded Rehabilitation Medicine Scientist Training Program (RMSTP) is divided into three phases. During the pre-applicant phase, trainees define one’s direction, identify a mentor and build a bio-sketch that is competitive for extramural career development funding. During the applicant phase, once they have found a mentor and have some aims for a career development research project, they are able to attend an annual workshop with more advanced content and are offered pre-reviews of grant applications. During the funded phase, participants have received either a K or R grant or similar funding from another agency and are given support in maximizing productivity during their funded career development, facilitating a transition to independence (such as negotiating a position).

There are currently trainees in all areas of rehabilitation research at all points along the research spectrum, including biopsychosocial models.

Questions/comments

The committee discussed whether enough is known about the structures of this model that could be generalizable to other fields.

  • The structure that puts different levels of researchers engaged in the same challenging tasks with close contact in a supportive way is important, especially in preventing people from departing from the field. It’s important for trainees to hear about the frustration and failure that occurs along the way and to hear that it is normalized and supported. The three phases of the R25 program don’ have to be set in stone but there is a logic to them that could be applied more broadly. As the program has matured there is feedback that participants value small group activities with people who are more senior to them who can provide guidance in a more individually tailored way.
  • There are parallels between physiatry and pain - any field where a mature scientist is likely to be working in a multidisciplinary setting, that makes the training of the scientist more challenging because there aren’t as many good role models.

The committee discussed if there were challenges for encouraging people to become mentors or bringing in the best mentors.

  • There aren’t enough mentors everywhere to provide support, so that they needed to be provided on a national basis. The R25 panel rarely provides mentorship themselves for the trainees, but help trainees find labs where they could provide mentorship that fits their needs.

It was discussed if the R25 program has an evaluation component for the mentors, and if so, what those evaluations look like?

  • There is a formal evaluation of the RMSTP mentors (evaluation of their lectures, small group facilitation, etc.,), and of the workshop and the program overall. There is no formal evaluation of the local K-funded mentor(s) because they are almost always "one-off" panels put together by the trainee. Quarterly meetings provide a "qualitative critique and the program helps facilitate resolution of problems with the local mentor where possible.

Perspective from anesthesiology
Christine Nai-Mei Sang, MD, MPH, Associate Professor of Anesthesia, Harvard Medical School Linda Porter, Laura Wandner, John Whyte, Christine Sang

Dr. Sang described a webinar held in May hosted by the American Union of Anesthesiologists (AUA) and the Anesthesiology Research Council (ARC). The webinar included presentations on workforce enhancement data from the ARC and NIH. These stakeholders noted common goals with the respect to the need to cultivate the next generation of physician scientists in anesthesiology and to build the pain research workforce pipeline overall.

Dr. Sang described the ARC’s Working Group on the Status & Future of the Anesthesiology Physician Scientist Pipeline. The working group’s goal was to support a commitment of anesthesiologists to discovery and clinical science, which is being threatened by decline of physician scientist workforce. The group had four charges:

  • Charge 1: Evaluate past and present research pipeline to define the scope of workforce shortage.
  • Charge 2: Identify factors associated with successful physician scientist launch.
  • Charge 3: Address diversity in the pipeline and factors that may differentially affect groups from background typically underrepresented in research.
  • Charge 4: Create series of strategic recommendations for individual physicians, scientific mentors, departmental chairs, medical school deans, funding agencies and policymakers to facilitate workforce growth.

The working group administered several surveys to assess support for research training in anesthesiology departments.

  • Survey 1 was administered to department chairs, residency program directors, federally funded investigators to assess research exposure, support and culture.
    • Around one-third of departments could do more to foster more research among medical students and could do more to foster research among residents. A majority of residents did not participate in any structured research during their residency.
    • Other findings included that: more mentors have mentored women than have been mentored by women; and more mentors have mentored those in underrepresented groups than those who have been mentored by a those from underrepresented groups.  This suggests that while there is currently a lack of diversity among mentors, there could be more female mentors and mentors from underrepresented backgrounds in the future.  
  • Survey 2 examined characteristics of programs and T32 grant trainees.
    • Among the 14 of 16 T32 director responded, 9 said that more than half of their trainees are still conducting research as a significant portion of their time (40 percent time for 2 years).

ARC research has also found that NIH funding to anesthesiology departments has increased over time, but relative rank in NIH funding in total dollars compared to other specialties is low. Additionally, the number of T32 awards for anesthesiology has remained stagnant but the number of K awards as risen

Ultimately, the Working Group reached the following conclusions:

  • Number of anesthesiology departments with NIH T32 funding has remained unchanged over 10 years;
  • Overall NIH funding to anesthesiology departments has increased over 10 years but remains low compared to other specialties;
  • Diversity of anesthesia research workforce, from trainees to mentors, remains an issue.

Some of the possible factors for these challenges included:

  • Individual level – a long training period.
  • Institutional – tension between clinical and research responsibilities;
    • Reduced protected time;
    • Attrition of senior physician scientists as mentors.
  • National - Poor recognition of importance of anesthesiology research;
    • Diverse and multidisciplinary nature of anesthesia research;
    • Lack of diversity in research workforce;
    • Need for career development programs at all stages.

And opportunities that were identified included:

  • Individual – expand support of trainees and mentors;
    • Increase diversity among trainees/mentors.
  • Institutional – attract grad/medical students to anesthesia/pain research;
    • Form research networks around questions that garner institutional interest;
    • Provide protected time for research to junior staff;
    • Support mentorship networks within and between institutions.
  • National - Promote importance of anesthesiology research;
    • Recognize interdisciplinary teams in pain research;
    • Refine metrics and track career development and progression.

During the open moderated session of this webinar, the questions and comments generated included:

    • Would NINDS and other institutes consider funding mechanisms similar to the R03 GEMSTAR (NIA) where foundations can partner to support the PDP?
    • Pain management is interdisciplinary; is NIH exploring or advancing anesthesiology partnerships with reearchers from other disciplines?
    • Would NIH consider the T35 grant mechanisms for med students that allow enrollment at multiple institutions?

Finally, the stakeholders acknowledged a common vision/mission:

  • Proposed shared research workforce vision: a robust anesthesiology/pain research infrastructure comprised of physician-scientists at all stages of career development, whose work informs outstanding patient care through novel discoveries and technologies.
  • Proposed shared research workforce mission: to advance scientific discovery through the development and dissemination of research in anesthesiology/pain medicine.

Questions/comments

It was suggested that there could be some kind of informal systematic review of training programs to increase the pain-related research workforce, to assess the common elements/assumptions in these programs.

The impact on the research workforce of academic institutions becoming part of larger hospital systems, which may not support an academic/research mission in the same way was discussed.

  • Even when there is support to do research, staff are overwhelmed by patient care.
  • Reimbursement rates may be one way to encourage or incentivize research training programs

It was asked if there is a way to evaluated outcome measure among patients who have been treated by physicians who have received research training and mentorship versus those who have not.

  • Patients will be part of advisory panels in a pair of upcoming NIH awards aimed to enhance the pain research workforce.

Dr. Kato as asked if it would be possible for AHRQ to do a systematic review of training programs aimed at increasing the research workforce.

  • While AHRQ is examining topics like this, defining the right outcomes and models would be a challenge, and taking up a topic like that would require having a robust panel of technical experts to make it productive.
  • It is challenging to do such a review in the rehabilitation space.

It was noted that HEAL gives us an opportunity to develop ambitious pain training programs that will likely be open to all relevant disciplines. The key is to get the message out to wide variety of health professionals that they should take advantage of these multidisciplinary opportunities.

CDC Opioid Prescribing Guidelines Update – Beth Darnall and Christine Goertz

Dr. Darnall and Dr. Goertz both participated in a working group that provided feedback on the Centers for Disease Control and Prevention’s update of opioid prescribing recommendations published in 2016. Dr. Darnall outlined the group’s role in the process and their concerns about the content of the updated guidelines.

Dr. Darnall described how the 2016 guidelines was meant to be limited to prescribing opioids in primary care (rather than in pain management) but said it was misinterpreted and misapplied with dose threshold suggestions that were taken as rigid rules that were in some cases codified into state law. As a result, numerous publications found evidence of harms and negative consequences of this misinterpretation of the guidelines. With the proposed revision, a key question was how the CDC was going to prevent harms due to misinterpretation. A working group was convened with 22 members tasked with reviewing the anticipated guidelines and making recommendations.

The working group’s guiding principles included minimizing bias in evidence; ensuring clinical evidence and data from real-worked patients were weighted appropriately; ensuring scientific integrity; ensuring inclusivity in terms of the complexity of the chronic pain experience, including patients with rare diseases; mitigating harms from unintended consequences documented after the 2016 guidelines wer adopted; ensuring conclusions in the updated guidelines were clear and would have a minimal influence on state or national policies.

Dr. Darnall said that the working group had two months to review the 200-page document. She described the revision as more of a pain treatment guideline rather than an opioid prescribing guideline, and expands its scope to pain specialists rather than just primary care. She said that the updated scope could create new risks of misinterpretation, and noted that certain pain conditions were excluded without an evidence base explaining why. Working group members were particularly concerned about recommendations for opioid tapering, which were not present in the prior guidelines, and how they may be misapplied.  She noted that the tapering guidelines seem at odds with 2019 tapering guidance from the Health and Human Services Dept., and that this could create confusion.

She said that some areas of the revised guideline were non-controversial – such as using caution when initiating opioids – but many if not most of the other areas engendered a high degree of discussion – there were divergent opinions, extensive debate on a few items. She was critical of aspects of the process including a lack of pain clinicians as part of the guideline’s authorship team and how the working group was sunset after its report was issued.

Dr. Goertz noted the difficulty of creating a document that is generally useful while also flexible enough to be patient-centered and physician-centered. She hoped that it was an improvement over the 2016 guideline and that there was an effort to incorporate opinions from the working group. However, she expressed concern about how the guidelines would be implemented, communicated and ultimately used.

Questions/comments

The group discussed if areas other than dosing and tapering that were at risk of being misapplied.

  • There there are vulnerabilities each step of the way, and that it is unclear that they are general guidelines or that the decision-making should be contextualized in individual diagnoses. There is a section on psychosocial and behavioral therapies, but there is not widespread access to these kinds of treatments and not every patient would respond favorably.
  • The guidelines need a greater appreciation of the complexity of individual patients that are being treated.

It was asked how the IPRCC can advocate that the new guidelines won’t be misapplied and not corrected for years, like with the 2016 version?

  • There is a lot of data on how the guidelines could be misapplied
  • It was suggested that there would be a system for monitoring for misapplication of the guidelines, but that the draft didn’t include that.
  • Alliance to Advance Comprehensive Integrative Pain Management issued a public comment on behalf of 44 individuals and organizations. Signers represent people with pain, the spectrum of health care providers, payors, academia and more: https://painmanagementalliance.org/2022/04/21/aacipm-responds-to-cdc-opioid-guideline/

It was asked how the CDC decided what diagnoses were excluded from the guidelines.

  • Some were excluded (cancer, sickle-cell disease) apparently because prescribing guidelines already exist for those conditions, but that exclusions could cause unnecessary confusion among clinicians.
  • The intent was to exclude to conditions where the harms had been clear, but important information to explain such exclusions was not included.
  • It is difficult to draft the guidelines in a way that it is specific enough to be useful yet broad enough not to cause unintended harms.

Several members asked if the IPRCC should do anything to address the guidelines.

  • It was noted that it is difficult for people to access opioid alternatives. Current payment policies, even for treatments that have strong evidence, are not broadly available to patients. It was suggested that the IPRCC could do more to push this issue to the forefront.
  • Concerns were raised about the omission of certain relevant studies. Confusion could arise between the updated guideline’s treatment of opioid tapering compared to the 2019 HHS guidance.

Dr. Porter reminded the group that non-federal members could write a letter about the guidelines if they would like, but that it would have to be clear that it was not speaking for the entire committee, as the federal agencies represented took part in the initial development process.

It was suggested that the IPRCC could recommend areas where there are research gaps in terms of the effectiveness of opioids, particularly with regard to rare chronic pain conditions and tapering concerns. Thre of the most underserved pain conditions are X-linked hypophosphatemia (XLH), complex regional pain syndrome (CRPS) and Ehlers-Danlos syndrome.

Closing remarks

Dr. Koroshetz and Dr. Langevin concluded the meeting by noting that the IPRCC has helped the NIH prioritize pain research and identify blind spots, encouraging the NIH to be creative and listen to patient views about what’s working, what’s not working and where more research is needed. Dr. Langevin encouraged IPRCC members to reach out before the next meeting with areas that the NIH should be focusing on.

Meeting adjourned.

 

These minutes were prepared by the Office of Pain Policy and Planning. - They have not yet been formally approved by the IPRCC. 

 

 

 

 

 

 

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