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Tuesday, July 16, 2013

 

Opening Remarks

Dr. Martha Somerman, Director, NIDCR, opened the meeting

News: Sleep-Pain Workshop proposal

Dr. Lee Alekel (NCCAM) presented a proposal to the Pain Consortium to gauge interest in partnering with NCCAM on a sleep-pain workshop.  Dr. Alekel proposed that this could either be a stand-alone workshop or a workshop in conjunction with the annual NIH Pain Consortium Symposium next spring.  Dr. Alekel provided some background on the relationship between sleep and pain noting that the bi-directional relationship between sleep and pain is not well understood, particularly the mechanisms by which sleep disorders affect pain.  Both sleep disorders and chronic pain affect approximately a quarter of the population, and significant overlap exists.  A basic conceptual framework was presented in which there is a bi-directional relationship between sleep and pain, sleep and health behaviors, and health behaviors and pain. Inflammatory processes and mood disturbances were included as potential mediators of the sleep/pain connection.  The proposed workshop would 1) bring together sleep and pain researchers to explore how these two fields might work together in conducting overlapping research with the potential to alleviate sleep disturbances and thereby ameliorate chronic pain; 2) Identify basic mechanistic gap areas/questions in relation to the common neurobiological systems that connect sleep/wake and nociceptive pathways and 3) Identify clinical gap areas/questions, particularly related to non-pharmacologic approaches, to alleviate sleep disturbances that hold promise in reducing chronic pain.  Many of the Pain Consortium representatives expressed interest in collaborating on such a workshop with NCCAM as the lead institute.

News:  Proposed Request for Application (RFA); Fostering the Development of Improved and Safer Pain Medications: Opiate-Sparing Strategies

Dr. Aidan Hampson (NIDA) presented a proposal to develop a research program on opioid-sparing adjunctive therapies.  The goals of the program would be to improve pain relief, patient safety and reduce development of addiction.  Dr. Hampson provided background on the issues with opiate treatment.  While opiates are efficacious analgesics, they have significant adverse effects which cause many long-term opioid patients to discontinue their use.  These side effects include depression, insomnia, withdrawal syndrome and opiate-induced hyperalgesia.  In addition, there are effects that make opiates dose-limiting such as nausea/emesis and respiratory depression (a major factor in accidental deaths).  Therefore, it is advantageous to seek drug therapies that use opioids sparingly. Dr. Hampson performed extensive searches for existing clinical trials for opioid combination therapies and found that overall there was a dearth of literature or clinical outcomes data on this topic.  Therefore, Dr. Hampson queried the consortium on its interest in development of an opioid adjuncts program with the following requirements: 1) Studies should require collaboration between pain specialists and specialists in other areas with unmet pain management needs; 2) Drugs tested should be of optimal clinical relevance (i.e., not intravenous or intrathecal delivery); and 3) Research data sharing plans should outline how data will be conveyed to clinicians outside the pain management field.  Following Dr. Hampson’s presentation, there was discussion about timeline and feasibility of such a project.  Members from the pain consortium executive committee suggested that Dr. Hampson further develop the proposal and include next steps, and budget/timeline components.  

News: Overlapping Chronic Pain Conditions

Dr. Linda Porter (NINDS) reported an update on the overlapping pain conditions workshop that was held in August 2012. Six key recommendations came from this workshop which included: 1) Leveraging of existing resources and data repositories; 2) Coordination of preclinical and clinical research; 3) Conducting longitudinal studies; 4) Studying central sensitization as a theme for discovery of common mechanisms of disease, diagnostics, and treatment; 5) Developing a case definition of chronic overlapping conditions and 6) Developing multidisciplinary research training programs in these disorders for researchers and health care providers; incorporating approaches to address health disparities in pain.  Two recommendations currently are being addressed: to leverage existing resources and data repositories; and study central sensitization as a common mechanism of disease, diagnostics, and treatment.  On June 3rd, there was a discussion with some Interagency Pain Research Coordinating Committee members to facilitate research on overlapping conditions by leveraging currently funded projects.  Three large NIH projects address overlapping chronic conditions: OPPERA II (Orofacial Pain: Prospective Evaluation and Risk Assessment) which focuses on temporomandibular joint disorder (TMJ), headache, low back pain, irritable bowel syndrome (IBS) and widespread bodily pain; MAPP II (Multidisciplinary Approach to Chronic Pelvic Pain) with a focus on chronic bladder/prostatitis pain; and the program project grant: Complex Persistent Pain Conditions which focuses on unique and shared pathways of vulnerability in fibromyalgia, vulvodynia, migraine, IBS, and TMJ.   The program directors of these projects met to discuss bringing together the principal investigators to consider the potential to facilitate consistent and overlapping collection of data elements and the potential to enhance the relevance of the projects to overlapping pain conditions.  Following Dr. Porter’s presentation, other PC representatives stated that they also fund grants that may be ideal for this type of collaboration.  Dr. Porter will follow up with interested program staff and setup a meeting with the principal investigators.

News: FNIH/NIH/Pfizer Partnership

Dr. Porter discussed a potential partnership with NIH and Pfizer which is being facilitated by the Foundation for NIH (FNIH). Pfizer’s medical education group is interested in accelerating the adoption of evidence-based innovations to address gaps in pain care.  Pfizer recently released and funded several requests for proposals (RFAs), which focus on topics such as appropriate opioid medication, diagnostic tools in pain care and optimizing healthcare utilization for chronic pain patients.  One role of the NIH Pain Consortium in the partnership would be to recommend selected research gaps.  Three topics have been selected and approved by the PC executive committee and will be submitted through the FNIH to Pfizer for consideration of their interest levels. 

Update:  Interagency Pain Research Coordinating Committee (IPRCC)

Dr. Porter provided an update on the IPRCC activities.  The IPRCC met on June 3rd, 2013 on the NIH campus. The major topics of discussion were the federal research portfolio analysis, public private partnerships, review of pain applications at the NIH, and recommendation 2.2 from the IOM report ‘Relieving Pain in America’.  

The federal research portfolio analysis is ongoing and currently in phase 4.  In phase 1, broad research categories were established to categorize the data and all IPRCC agencies were asked to code their pain-related research.  In phase 2, which was completed in October 2012, a two-tier coding system was established: In tier 1, grants were coded as basic, clinical and/or translational; in tier 2, grants were coded with more specific categories that covered specific topics such as mechanisms, training, drug development, and others.  In phase 3, these data were analyzed by most frequently coded pain conditions, groupings of related pain conditions and most frequently coded tier 2 categories and were submitted to the IPRCC for review.  In phase 4, IPRCC members selected a condition or set of conditions to further analyze and specifically address the following: 1) Overview of the research area; 2) Potential for overlap or shared interests among agencies or NIH institutes; 3) Relevance to other conditions; 4) Opportunities to share resources or collaborate; and 5) Potential gaps: research needed but not represented in the portfolio.  These analyses were presented at the June 3rd meeting.  The next step for the portfolio analysis is to develop a FY2011 portfolio analysis report. 

Dr. Maria Freire from the Foundation for NIH (FNIH) gave a presentation describing public private partnerships and the role of FNIH in facilitating and executing such partnerships.

Dr. Richard Nakamura, Director of the Center for Scientific Review gave a presentation at the June 3rdmeeting.  He gave an overview of the review process and provided data from an analysis of pain research peer review.  A large portion of pain grants are reviewed in the Somatosensory and Chemosensory Systems (SCS) study section.  The SCS section reviewed 49% of pain grants versus 43% taste and smell, and 8% other.  Overall, the pain peer review, which focused on unsolicited R applications, showed no major differences in the percent discussed, mean priority score or percentile within the SCS study section or in Human Subjects pain applications.  

In October 2012, the Assistant Secretary for Health, Department of Health and Human Services tasked the IPRCC and NIH to address IOM recommendation 2.2 which states: “develop a comprehensive, population health-level strategy for pain prevention, treatment, management, education, reimbursement, and research that includes specific goals, actions, time frames, and resources”. To address this goal, the IPRCC has established an oversight panel and 5 working groups: 1) Professional education and training; 2) Public education and communication; 3) Population research; 4) Public Health: Prevention, care, & disparities; and 5) Public Health: Services and reimbursement.  The Oversight panel will be chaired by Dr. Sean Mackey from Stanford University and Dr. Linda Porter, Health Policy Advisor for Pain.  The members of the oversight panel have been established and include members of the IPRCC.  Currently, the chairs and members of the ‘Professional education and training’ and ‘Public education and Communication’ working groups are being established.  An operational flow chart and preliminary timeline has also been prepared.

Update: Centers of Excellence for Pain Education (CoEPEs)

Dr. Dave Thomas (NIDA) gave a brief update on the CoEPEs. The CoEPEs are in the process of developing curriculum case studies to educate students at medical, pharmacy, nursing, and dental schools.  The Pain Consortium members are asked to provide review of these case studies.  Dr. Thomas attended the American Pain Society in May and gave a presentation on the CoEPEs which was well attended.  Currently, Dr. Thomas is working with the Foundation for NIH to discuss opportunities for additional CoEPEs projects.

Update: Evidence Based Workshop on Chronic Pain and Opioids

Dr. Thomas provided an update on the evidence-based workshop on chronic pain and opioids.  This workshop is designed to evaluate selected questions related to opiate efficacy in the treatment of chronic pain.  To date, a small group of representatives have met to discuss a number of focus questions for the workshop.  A subsequent meeting is planned with the chairs of the workshop committee to further establish the questions and timeline.

Update:  Stanford, NIH Pain Registry

Dr. Richard Denisco (NIDA) provided an update on the Stanford and NIH Pain Registry.  To date, development of a functional prototype of the pain registry and preliminary use of clinician and patient scenarios has been accomplished.  Data has been collected on over 1500 patients.  The data collected include initial longitudinal measures of health status (integrated PROMIS measures) and male and female body maps (used to select areas where pain is experienced).  In June 2013, an expanded ontology was developed and implemented.  Future opportunities provided by the registry data include its use in comparative effectiveness studies and scaling the registry to other sites. In addition, a physician interface to visualize and interact with longitudinal patient data is being developed as well as an ongoing cross-platform multi-browser support system for mobile devices.

Update:  Twitter

Dr. Tara Schwetz (NINDS) informed the Pain Consortium members that the Office of Pain Policy has established a twitter account (@NIHPainResearch). This account was created to provide pain-related updates of activities from the NIH Pain Consortium, the Interagency Pain Research Coordinating Committee (IPRCC) and the National Pain Strategy.  In addition, the account will be used to relay information about FOAs, recent science advances, etc. that may be of interest to the pain community.  This account was created on June 19th, and has already increased the number of visits to the Pain Consortium and IPRCC websites.

Important Dates for 2013

Pain Consortium Quarterly Meetings 2013

  • October 22, 2013, 1PM – 2:30 PM  Bldg 31,  8A28, Call-in: 1-877-249-7084, Passcode: 2022985