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Friday, July 27, 2018

Pain Consortium Quarterly Meeting

Summary:  Dr. Koroshetz welcomed the group and provided an update on the NIH HEAL Initiative.  The following meetings and workshops were discussed:  CMS/NIH Leadership Forum on Pain and Addiction; Pain Biomarker Discovery Workshop; Cold Spring Harbor Meeting on Models of Pain Care for Management of Chronic Pain; and several pain-related NCCIH-led workshops and meetings.  Updates were given on the following topics:  Interagency Pain Research Portfolio Database/Call for Coders; Research, Condition, and Disease Categorization (RCDC) pain categories; and the Centers of Excellence for Pain Education.

Welcome and Update
Walter Koroshetz, Chair, NIH Pain Consortium Executive Committee

Dr. Koroshetz welcomed the group and provided an update on new funds for pain research. In 2018, Congress appropriated $250 million for pain research. The NIH Pain Consortium and other NIH Institutes and Centers are developing proposals for review by NIH leadership to enhance pain research.  At NINDS, some proposals have been accepted to move forward as part of the NIH HEAL initiative. These proposals are open to the mission of multiple institutes.  FOAs for validation of novel non-addictive pain targets are being considered. An FOA on Analytical and/or Clinical Validation of a Candidate Biomarker for Pain is also under consideration. Funding of the FOA projects will come from the NIH HEAL initiative, not the individual ICs.

A clinical trial network for pain is under development as part of the NIH HEAL Initiative. The trials would be pain disorder specific and involve deep phenotyping of small populations and biomarker validation.  NINDS is developing a preclinical testing platform in animal models of pain, while NCATS is developing an in vitro screening platform for pain for model/device testing.  The Acute to Chronic Pain Transition Common fund FOAs are currently in the FOA module. The tentative timeline for publishing the FOAs is late August.

Information regarding upcoming FOAs will be sent out through the NIH Pain Consortium internal listserv.  Pain consortium representatives are asked to pass along the FOAs to others within their institute that may be interested in signing on. The NINDS Office of Pain Policy and Planning has various distribution lists that reach pain researchers and the larger pain community (stakeholders, professional societies, and patient advocates).  A list of previously or currently funded pain research principal investigators is maintained as well as a list of clinical PIs in the pain field.  PC Reps may contact Linda Porter for distribution of notices and FOAs and include contact information for direct replies.  Webinars will also be held for the various initiatives and in some cases may be combined.  When notices are sent out, each of the ICs can then amplify the message to their respective groups.   The NIH Pain Consortium website will develop a central webpage for pain-related HEAL initiative notices, projects and webinars.  Members discussed ways to simplify the incoming information including a weekly summary or categorizing announcements by preclinical v. clinical.  All NIH HEAL Initiative FOAs will first be posted on the main NIH HEAL website maintained by the Office of the Director.

CMS/NIH Leadership Forum on Pain and Addiction
Linda Porter on behalf of Wilson Compton, Deputy Director, NIDA

Dr. Compton was unable to attend the meeting and will provide an update at the next meeting.  Dr. Porter provided a brief overview. In January 2018, the CMS/NIH leadership council asked for a working group on opioids. From NIH, there are reps from NINDS, NIDA and NCCIH. The goal of the working group is to identify gap areas in the evidence base for pain treatments and medication so that CMS can address current policies for reimbursement and ensure treatments that work are included in their system, and those that do not work, or are not cost-effective are removed. Multiple subgroups were established including a working group on pain management and one on acupuncture, a topic CMS is very interested in.  The primary goal of CMS is to look at comparative effectiveness of different treatments.

Pain Biomarker Discovery Workshop
Mary Ann Pellymounter, Program Director, NINDS

Dr. Pelleymounter announced an upcoming NIH workshop on the ‘Development of biomarkers to facilitate the discovery of non-addictive pain medications’ to be held on Nov. 14-15 at the Marriott in Washington, DC.  The goals are to 1) Develop consensus on definitions of biomarkers, types of biomarkers, and the process of discovery and development of biomarkers; 2) Evaluate the state of the science in pain biomarker development; and 3) Explore scientific collaborative approaches to accelerate the discovery of biomarkers.  Many of the Pain Consortium representatives are on the organization committee (9 ICs). At this stage, approximately 77% of speakers are confirmed.

A meet and greet will be held via teleconference which will be open to all. The teleconference will cover how grants will be administered and awarded as well as receipt and referral.

Cold Spring Harbor Meeting on Models of Pain Care for Management of Chronic Pain
Linda Porter, Director Office of Pain Policy and Planning

Dr. Porter provided an update on an upcoming meeting. The meeting is by invite only. Dr. Porter and pain researcher Dr. Dan Clauw are hosting a meeting on models of pain care addressing important areas that go beyond the research realm.  The meeting will focus on what models of care are currently being utilized and what is or is not working. Discussions will include how to draw in payers to incentivize what’s working and to start to move private and public payers in that direction.  The overall goal would be to enable policy for payment of integrated pain care.    Persons representing primary care, specialty care, pediatrics, elderly, large private payers, self-management, psych mgmt., integrated programs, VA, DoD, NIH, FDA, and CMS will be in attendance.  The meeting is funded by the Mayday Fund and directly follows the IASP meeting in September. 

IPRP Database Update and Call for Coders
Cheryse Sankar, Senior Policy Analyst, NINDS

Dr. Sankar provided an update on the Federal Pain Research Database also known as the Interagency Pain Research Portfolio (IPRP).  Grants from 2012-2016 are now publicly available on the paindatabase.nih.gov website. Over the last year, the site and data were optimized to ensure accurate information and facilitate future coding.  Coding will now occur on an annual basis to keep the database as up to date as possible. Drs. Grady and Koroshetz initiated a discussion about the potential for tracking HEAL initiative grants through the pain database.  Tracking supplements may be challenging.  Members discussed initiating a conversation with external stakeholders regarding the pain research budget and expected changes given the HEAL initiative funding.

Updates on RCDC pain categories
Partap Khalsa, Director Division of Extramural Activities, NCCIH

Dr. Khalsa provided an overview of the RCDC Pain Conditions – Chronic Category Revisit Session held in early May.  In an effort to update their coding guidelines, the RCDC staff asked pain experts across the institutes and centers to attend a meeting to clarify coding parameters for chronic pain.  There were approximately 10 ICs represented.  The RCDC staff sought clarification in the following areas:  Differentiating between the Pain Research and Pain Conditions – Chronic categories; Defining “chronic pain”; Chronic conditions that may be painful and painful conditions that may be chronic;

Inclusion of basic research studying “pain in general”; Extent of inclusion of opioid research; Palliative care/end of life care/suffering; and Mental health and chronic pain.  Some consensus was reached regarding the discussion areas:

  • Projects that examine pain in a chronic condition are relevant to the category because it is difficult to draw the line between acute and chronic pain in these conditions. If there is a hallmark of pain to the chronic condition (fibromyalgia, complex regional pain syndrome, migraine, sickle cell disease, neuropathies, etc.) it is included. Agreed that the category name of pain conditions - chronic is confusing and voted to change the name to “Chronic Pain.” This name change will be submitted to Governance for final approval.
  • Routine definition of chronic pain is pain that persists beyond the normal period of healing. A more quantifiable definition is pain that persists or recurs for more than 3 months. As there is no one agreed-upon definition and researchers may not mention duration in their discussion of pain, the experts did not feel that it would be conducive to supply specific criteria for what could be considered “chronic pain.”
  • Regarding inclusion of basic research in the category: agreed that neuropathies are always relevant (chemotherapy-induced, diabetic, peripheral, etc.); agreed that any basic research had to have a pain outcome or be in a chronic pain population.
  • Opioid research should not be immediately included, especially if the focus is on addiction, dependence, tapering, or misuse, unless these aspects are being studied in a chronic pain population. The experts agreed that all research in a chronic pain population is relevant, even when not focused on the pain, because this research could inform chronic pain research.
  • Palliative care research needs to be specifically managing or measuring chronic pain to be included.
  • Mental health research that informs chronic pain mechanisms or susceptibility is relevant.

NCCIH Activities at IASP, NAS workshop on non-pharmacological pain management, Natural Products workshop
Wen Chen, Program Director, NCCIH

Dr. Chen provided information on upcoming meetings and workshop being hosted by NCCIH. 

The International Association for the Study of Pain (IASP) meeting will take place September 11-16th in Boston, MA.  A one-day IASP satellite symposium entitled “Chronic Pain: The Science of Complementary and Integrative Health Approaches” will be held on 9/11/2018 in Boston.  The symposium is co-sponsored by NCCIH, NIH OBSSR and the NIH Pain Consortium.  More information may be found here: https://nccih.nih.gov/chronic-pain-symposium-2018

An open format workshop, led by Dr. Emmeline Edwards, at IASP on music, the brain and chronic pain will be held on 9/13/2018.

An open National Academy of Science meeting on natural products is currently in the planning stages with a tentative goal of April 2019. A workshop for the meeting will be held on December 4-5th, 2018. The meeting is co-sponsored by multiple ICs. Dr. David Julius has agreed to co-chair. Suggestions for an additional co-chair are welcome.

Updates on the Centers of Excellence for Pain Education
Dave Thomas, Program Director, NIDA

The Centers of Excellence in Pain Education (CoEPEs) is an ongoing program with support from NIDA and the NIH Pain Consortium.  The 10th CoEPEs module has been released and is on the Pain Consortium – CoEPEs website.  Dr. Thomas stated that there are bi-weekly meetings that are ongoing and that an in-person meeting will be held at the end of September.  The goal is to get dedicated funding for the infrastructure and promotion of the program modules.  An update to the CoEPEs website will include an ‘iFrame’ which will contain updates and events related to provider education on pain.  Ultimately, Dr. Thomas would like to develop a pain portal that incorporates the CoEPEs and other National Pain Strategy Provider Education components.

Dr. Koroshetz announced that Dr. Patricia Grady will be retiring as Director of NINR.  This meeting marks her last NIH Pain Consortium meeting.  Dr. Koroshetz and other members thanked Dr. Grady for her service and wished her well. 

The next quarterly meeting will take place on October 26th from 3:30 p.m.-5:00 p.m.