WE HAVE A FULL AGENDA. I'LL GIVE A SENSE OF WHAT'S COMING UP, THERE'S BEEN A LOT OF ACTIVITY TO PUT TOGETHER A PLAN THAT WOULD INCLUDE INTENSIVE EFFORTS TO DEVELOP A NON-ADDICTIVE PAIN TREATMENTS INTEGRATED WITH TO ADDRESS THE OPIOID CRISIS. THE IPRCC HAS FUNDING THIS TIME WE HAVE BETTER LUCK. WE'RE EXCITED ABOUT THE STRATEGIY ROLLED OUT BY THE IPRCC, ALL THE VOLUNTEERS, OFFICE OF PAIN POLICY, WORK SO HARD TO GET THIS OUT. ALLEN BASBAUM, WHO WAS THE CHAIR, CO-CHAIR OF THE EFFORT WITH LINDA WILL BE CALLING IN DURING THE PRESENTATION. DR. VANILA SINGH PLANS TO TELL US ABOUT THE STATUS OF A NEW TASK FORCE FOR PAIN MANAGEMENT, WE'LL REVIEW CURRENT PAIN MANAGEMENT AND PRACTICE GUIDELINES, SO THIS IS A NEW FACA TASK FORCE BY HHS. WE HAVE UPDATES FROM IPRC REPS FROM THE FDA, HRQ, AND DoD, AROUND CURRENT PAIN-RELATED ACTIVITIES. IN THE AFTERNOON WE'LL SPEND ON UPDATES FOR THE NATIONAL PAIN STRATEGY. ALICIA RICHMOND SCOTT, CATHY UNDERWOOD WILL TAKE ABOUT AWARDS TO ADDRESS THE OBJECTIVES OF THE NATIONAL PAIN STRATEGY AND CHAD HELMICK WILL PRESENT PROGRESS ON THE NATIONAL HEALTH INTERVIEW SURVEY. AND AS I MENTIONED, WE STARTED THAT NIH LED BY DR. COLLINS IS TRYING TO DEVELOP A PUBLIC/PRIVATE PARTNERSHIP TO ADDRESS RESEARCH THAT MIGHT HELP DEVELOP NON-ADDICTIVE EFFECTIVE MEDICATIONS FOR PAIN, AND ALSO BETTER WAYS TO TREAT ADDICTION, KIND OF A TWO-PRONGED EFFORT, AND HE WILL COME AND TELL US ABOUT THAT TOPIC AFTER WHICH NORA VOLKOW AND I WILL TALK ABOUT THE TWO STREAMS, TWO PILLARS OF OPIOID OVER USE DISORDER RESEARCH AND DEVELOPMENT OF NON-ADDICTIVE PAIN TREATMENT. LEAH WILL TALK FROM LINDA'S OFFICE, , POGORZALA. WE HAVE A FEW BRIEF ANNOUNCEMENTS. WE STILL HAVEN'T HAD OFFICIAL APPROVAL OF OUR SLATE OF MEMBERS. LINDA THINKS WITHIN THREE DAYS THAT WILL HAPPEN. THE NOMINEES WE WELCOME, ROGER, JAN CHAMBERS AND DAN CARR HAVE BEEN WAITING PATIENTLY, GLAD THEY COULD JOIN US TODAY AS AD HOCS. WE THANK THEM FOR STAYING ON DURING THE TRANSITION PERIOD AND EXTENDING TERMS. THAT REALLY IS IMPORTANT. WE COULDN'T HAVE DONE IT WITHOUT THEM. WE'RE GOING TO GO QUICKLY BECAUSE WE'RE BEHIND. SINCE THIS IS ABOUT PAIN RESEARCH, I WANT TO MENTION SOME EXCITING BASIC RESEARCH THAT'S COMING OUT ON PAIN. IT'S FAIR TO SAY RESEARCH AND UNDERSTANDING PAIN CIRCUITS IS STILL MOVING AT A RAPID PACE, AND EVERY COUPLE MONTHS THERE'S SOME HIGH PROFILE DISCOVERY THAT'S COMING OUT ON PAIN. SO I THINK WE CAN BE QUITE PROUD AND ENTHUSIASTIC ABOUT THE RESEARCH THAT'S BEING DONE. SO JUST TO THROW OUT A COUPLE THINGS. THIS WAS SOMETHING THAT CAME OUT IN MAY, AND IT TALKS ABOUT PD-L1 IN THE DORSAL ROOT GANGLION CELLS. PD-L1 IS A CHECKPOINT INHIBITORS BEING BLOCKED IN CANCER PATIENTS, AND HAS BEEN REALLY DRAMATIC IN REVERSING SOME TUMORS. IT'S PRODUCED BY SAY MELANOMA CELLS, AND THIS PAPER THEY FOUND THAT THEY COULD ASSAY MELANOMA CELLS AND ALSO DORSAL ROOT GANGLION CELLS, SEEN ON THE LEFT, AND THEN ON THE SCIATIC NERVE SEEN ON THE RIGHT HERE, THE PD-L1 IS TURNING DOWN THE PAIN SIGNAL IN THE DORSAL ROOT GANGLION CELLS. A NICE EXAMPLE DISCOVERIES THAT COME OUT OF CANCER RESEARCH, YOU NEVER KNOW, BECAUSE THEY ARE ALL -- A LOT OF MECHANISMS ARE COMMON TO ALL DIFFERENT TYPES OF CELLS RESEARCH FROM, SAY, CANCER CAN REALLY HELP PAIN. ANOTHER PAPER, I WON'T GO THROUGH THE DETAILS, WHAT THEY DID THERE'S BEEN DISCOVERED THERE'S THIS MICRORNA, SO IT'S AN RNA THAT'S MADE BUT IT'S NOT TURNED INTO A PROTEIN. INSTEAD WHAT IT DOES IS REGULATES A WHOLE SUITE OF OTHER PROTEINS AND THIS microRNA HAS BEEN FOUND TO BE ASSOCIATED WITH 80% OF ALL OF PROTEINS THAT GET TURNED ON IN SOME MODELS OF CHRONIC PAIN. AND SO IN THIS GROUP WHAT THEY CAN DO IS BASICALLY KNOCK OUT THE microRNA AND SO IT'S LIKE THIS MASSIVE SWITCH YOU CAN TURN ON AND OFF, AND THIS IS AN EDITORIAL FROM THAT PAPER, KIND OF SHOWS -- WE TALK ABOUT THE PAIN-O-METER, SOMETHING THAT TURNS UP AND DOWN PAIN, AND SOMETHING YOU COULD MEASURE, SO THIS IS SOMEWHAT SIMILAR. THE PROBLEM IS IT'S IN THE CELLS, NOT SOMETHING WE CAN GET HOLD OF NOW, BUT JUST INDICATES THERE ARE POTENTIALLY MASTER SWITCHES THAT TURN THE GAIN UP ON PAIN, AND IF WE COULD MEASURE SOMETHING LIKE THIS IT WOULD BE OUTSIDE THE DORSAL ROOT GANGLION CELL, IT WOULD REALLY HELP US. THERE'S ANOTHER ONE, THERE ARE RECEPTORS, TRACK B RECEPTORS, AND THIS IS FOR SUBSTANCE P RECEPTORS, ON THE SURFACE OF DORSAL ROOT GANGLION CELLS, AND WE KNOW A LOT ABOUT HOW THEY MEDIATE PAIN. THIS PAPER ACTUALLY IS TALKING ABOUT NOT JUST RECEPTOR ON THE OUTSIDE OF THE CELLS BUT CLAIMING THERE'S A ROLE IN PAIN MODULATION FOR WHEN THE RECEPTOR MOVES OFF THE MEMBRANE INTO THESE LITTLE ENDOSOMES THAT CAN THEN MOVE THROUGH THE CELL. HERE'S A INITIAL PICTURE. IN A, THAT LINE ON THE TOP, THAT'S THE CELL MEMBRANE. THAT'S WHERE MOST OF THE ACTION IS THAT WE'VE ALWAYS BEEN STUDYING. THEN WHAT HAPPENS WHICH IS THE RECENT DISCOVERY IS THAT SOME OF THESE RECEPTORS COME OFF THE MEMBRANE, YOU SEE THAT BLEB, NUMBER 7, WHICH FORMS INTO THIS ENDOSOME NUMBER 8, AND IF YOU CAN BLOCK THAT FROM HAPPENING YOU CAN DECREASE HYPERSENSITIVITY IN SOME MODELS OF PAIN. AN EXAMPLE OF SOMETHING COMPLETELY NEW HOW PAIN IS MEDIATED AT THE CELLULAR LEVEL. I WANTED TO THROW OUT THOSE TEASERS. THERE'S LOTS OF TARGETS TO GO AFTER, WAYS OF MODULATING THE PAIN SYSTEM COMING FROM THE SCIENCE AT WORK THAT'S BEING DONE IN UNIVERSITIES AROUND THE COUNTRY. SO WITH THAT, I'M GOING TO JUMP TO LINDA. SHOULD WE GO AROUND THE TABLE? >> YEAH, THAT WOULD BE GREAT. >> I THINK THE LINES ARE OPEN SO IT WOULD BE GOOD MAYBE IF PEOPLE WOULD GO AROUND THE TABLE AND JUST INTRODUCE THEMSELVES. SO I'M WALTER KOROSHETZ, DIRECTOR OF NINDS, I WORK FOR LINDA WHO IS IN CHARGE OF THE OFFICE OF PAIN POLICY. MARTHA? >> MARTHA SOMERMAN, DIRECTOR OF NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH. >> KATHY UNDERWOOD CEO OF THE AMERICAN PAIN SOCIETY. >> SHARON HERTZ, DIRECTOR OF THE DIVISION OF ANESTHESIA AT FDA CDER. >> DENISE STEINBERG, NATIONAL POLICY DIRECTOR NATIONAL PAIN FOUNDATION. >> CHAD HELMICK MEDICAL EPIDEMIOLOGIST WITH ARTHRITIS PROGRAM AT THE CENTERS FOR DISEASE CONTROL AND PREVENTION. >> CHRISTINA SPELLMAN, MAY DAY FUND. >> JUDY PACE, NORTHWESTERN, DIRECTOR OF THE CANCER PAIN PROGRAM. >> PENNY COWEN, FOUNDER AND CEO OF CHRONIC PAIN ASSOCIATION. >> GOOD MORNING, RIC RICCIARDI, AGENCY FOR HEALTH CARE RESEARCH AND QUALITY. >> HI, MICHAEL PASTORNAK, FACIAL PAIN RESEARCH FOUNDATION. >> ROGER FILLENNEN, UNIVERSITY OF FLORIDA. >> (INDISCERNIBLE) FOR DEPARTMENT DEFENSE. >> DAN CARR, TUFTS UNIVERSITY, PAIN EDUCATION AND POLICY. >> DAVID SHURTLEFF, ACTING DIRECTOR NATIONAL CENTER FOR COMPLEMENTARY AND INTEGRATIVE HEALTH, TAKING OVER FOR JOSIE BRIGGS WHO RETIRED JUST ABOUT A WEEK AGO ACTUALLY. >> BILL MAXNER DUKE UNIVERSITY DEPARTMENT OF ANESTHESIOLOGY. I DIRECT THE CENTER FOR TRANSLATIONAL PAIN MEDICINE WITH MY CO-DIRECTOR DR. RONG JI HIGHLIGHTED ON THE FIRST SLIDE. >> LINDA PORTER, DIRECTORY OF PAIN POLICY NINDS, AN JAN CHAMBERS IS ON HER WAY, HAD A DELAYED FLIGHT THAT LANDED HER IN ATLANTA INSTEAD OF WASHINGTON. IT'S BEEN A ROUGH TRAVEL DAY ALAN BASBAUM IS LISTENING BY VIDEOCAST, WASN'T ABLE TO BE HERE IN PERSON. JAN TABERS HAS A VERY IMPORTANT ANNOUNCEMENT. I GOT AN E-MAIL FROM HER THIS MORNING, SAID SHE HAS A GRANDSON. A VERY NEW GRANDSON. IT'S A BABY BOY. SO WE CONGRATULATE JAN WHEN SHE GETS HERE. SO WE CAN MOVE FROM THERE BECAUSE WALTER HAS NICELY KIND OF RESET US CLOSE TO BEING ON SCHEDULE. WE SENT THE MINUTES FROM THE OCTOBER OR LAST FACE-TO-FACE MEETING OUT ABOUT A WEEK AGO, AND HOPEFULLY YOU HAD A CHANCE TO READ THROUGH THEM. IF NOT THEY ARE IN YOUR PACKET. YOU CAN TAKE A QUICK LOOK NOW AND LET US KNOW IF THERE'S ANYTHING IN THERE THAT YOU SEE THAT'S PROBLEMATIC, WE'LL MAKE THOSE REVISIONS. OTHERWISE WE NEED A FORMAL APPROVAL. WE'LL GIVE YOU A MINUTE OR SO TO LOOK AT IT AND THEN I'LL ASK SOMEONE TO MOVE TO APPROVE. >> MOTION TO APPROVE. >> SECOND. >> ALL IN FAVOR OF APPROVAL OF MINUTE MEETINGS? >> AYE. >> THANKS YOU >> THANKS VERY MUCH. BACK TO WALTER TO INTRODUCE OUR FIRST SPEAKER. >> PLEASED TO HAVE PATRICIA LABOSKY HERE, OVERSEES PROGRAMS INCLUDING COMMON FUND, SHE COVERS SEVERAL COMMON FUND PROJECTS, PLAYED A KEY ROLE IN DEVELOPING CONCEPT PROPOSAL ON PAIN WHICH SHE WILL TALK TO US ABOUT, DONE WITH MEMBERS OF THE NIH PAIN CONSORTIUM, WHICH IS THE TRANS-NIH GROUP HERE THAT INTEGRATES OUR PAIN RESEARCH AND COORDINATES OUR PAIN RESEARCH, AND SHE WILL TELL US ABOUT THE COMMON FUND AND ABOUT THE CONCEPT THAT'S BEING DEVELOPED AS A PROPOSAL AND WE CERTAINLY APPRECIATE ANY ADVICE YOU HAVE ON THIS PROCESS AND TOPIC. SO THANKS. PATRICIA? >> THANK YOU. GOOD MORNING, EVERYBODY. I'M GLAD YOU WERE ABLE TO GET HERE. AND I'M AMAZED AT HOW Y'ALL CHANGED EVERYTHING TO GET IT ON TIME. IT'S REALLY IMPRESSIVE. SO I'M GOING TO TELL YOU JUST A LITTLE BIT ABOUT THE COMMON FUND FIRST, SO THAT YOU CAN KIND OF UNDERSTAND WHERE WE'RE COMING FROM AND THEN I'M GOING TO GO ON TO TELL YOU ABOUT A VERY PRELIMINARY PLAN WE HAVE FOR SOMETHING WE'D LIKE TO TRY TO ADDRESS IN THE AREA OF PAIN. SO THE COMMON FUND IS SITUATED IN THE OFFICE OF THE DIRECTOR, AND THERE'S A BUNCH OF OFFICIAL LANGUAGE UP THERE THAT TELLS YOU, YOU KNOW, WHEN IT WAS -- OH, THANKS -- WHEN IT WAS STARTED AND, YOU KNOW, ALL THE VARIOUS DIVISION NAMES AND ALL OF THAT. BUT I THINK THAT THE MOST IMPORTANT THING FOR US TO THINK ABOUT TODAY IS HOW COMMON FUND IS A LITTLE BIT DIFFERENT THAN THINGS YOU MIGHT BE USED TO HEARING ABOUT. SO THE IDEA IS IT'S SUPPOSED TO BE ALMOST LIKE A VENTURE CAPITAL SPACE WITHIN THE NIH FOR PROJECTS THAT ARE GOING TO BE A LITTLE BIT DIFFERENT. THEY ARE ALWAYS SUPPOSED TO BE -- THEY HAVE TO BE THESE FIVE CRITERIA HERE ON THE LEFT. TRANSFORMATIVE, SO THEY REALLY HAVE TO HAVE AN EXCEPTIONALLY HIGH AND BROADLY APPLICABLE IMPACT. SO WE ALWAYS SAY THAT ALL OF OUR SCIENCE IS TRANSFORMATIVE. THIS IS TAKING THAT UP TO PERHAPS A LITTLE BIT HIGHER LEVEL. THEY ARE ALL CATALYTIC SHORT-TERM PROGRAMS VERY GOAL AND MILESTONE DRIVEN. THEY WON'T JUST WORK TOWARD GOALS. THEY HAVE TO ACCOMPLISH THEM. THEY ARE USUALLY RUN AS COOPERATIVE AGREEMENTS SUCH THAT IF THE GOALS ARE NOT BEING MET THERE ARE CHANGES MADE IN THE PROGRAM, BUDGETARY CHANGES, WHATEVER IT TAKES TO GET THE GOALS AND MILESTONES MET. THEY ARE SYNERGISTIC AND ENABLING, VALUE ADDED TO MULTIPLE NIH INSTITUTES AND CENTERS. IF IT'S A PROJECT DONE IN ONE INSTITUTE OR CENTER THAT WOULD NOT BE APPROPRIATE. IT HAS TO SPAN MANY MISSIONS OF THE CENTERS, THAT'S OBVIOUS FOR PAIN. THEY REQUIRE A HIGH LEVEL OF TRANS-NIH COORDINATION. I'LL SHOW YOU A GROUP OF A BUNCH OF PEOPLE THAT HAVE BEEN BRAINSTORMING ABOUT THIS, HOW TO TRY TO MAKE IT POSSIBLE. THEY USUALLY HAVE COMPLEX ISSUES ARISING THAT REQUIRE TRANS-NIH WORKING GROUPS, TEAMS, EXPERIENCE FROM MANY AREAS OF SCIENCE, AND FINALLY THEY HAVE TO BE NOVEL, SOMETHING THAT HASN'T BEEN DONE BEFORE, NOT AN EXTENSION OF SOMETHING THAT HAS BEEN DONE. IT HAS TO BE DIFFERENT. I LIKE TO THINK OF IDENTIFY AS MOVING THE NEEDLE IN AN AREA OF SCIENCE IN A WAY THAT WOULDN'T BE ABLE TO BE DONE IN ANY OTHER WAY. SO, AGAIN, SHORT-TERM CATALYTICS, FIVE OR TEN YEARS MAX, AND THAT'S PER CONGRESS. SO WE CANNOT RUN ANYTHING OVER 10 YEARS. THIS IS NOT THE WAY TO START SOMETHING THAT YOU WANT TO RUN FOR 20, 30, 40 YEARS TO MOVE SCIENCE AHEAD. SO TO GIVE YOU AN IDEA, THIS IS A LITTLE BIT OUTDATED BUT TO GIVE YOU AN IDEA OF SOME PROGRAMS AT LEAST FROM LAST FISCAL YEAR, THEY ARE HIGHLIGHTED UP THERE. AND YOU PROBABLY HEARD OF SOME OF THESE. HUMAN MICROBIOME IS ONE. THAT'S ONE EVERYBODY HAS HEARD ABOUT LATELY. THE MICROBIOME IS GOING FULL POWER, WE MOVED IT INTO THE HUMAN REALM WITH WORK FROM OUR OFFICE. WE DO THINGS IN TRAINING, ENHANCING DIVERSITY OF THE NIH-FUNDED WORK FORCE, STRENGTHENING BIOMEDICAL RESEARCH WORKFORCE, WE DO THINGS REALLY TRYING TO CHANGE THE LANDSCAPE. LIKE THE FOUR DIMENSIONAL NUCLEOME, NOT JUST THE STRUCTURE OF THE NUCLEUS AND HOW THAT MIGHT BE DIFFERENT BUT OVER TIME AND OVER DISEASE STATES AND THINGS LIKE THAT, BRINGING TOGETHER CUTTING EDGE IMAGING TECHNOLOGY WITH THINGS LIKE HIGH C AND OTHER SEC NECKS TO THINGS. THERE'S PROGRAMS HERE SOME WE MAY COLLABORATE WITH IF THIS PAIN THING HAPPENS. AND ONE OF THOSE IS MOLECULAR TRANSDUCERS OF PHYSICAL ACTIVITY. WE ALL KNOW EXERCISE IS GOOD FOR US, RIGHT? WE'RE TOLD THAT FOREVER. BUT ON A MOLECULAR LEVEL WHAT'S CHANGING AND HOW MIGHT THAT BE OF HAVE MORE BROADLY. SO WHY A COMMON FUND PROGRAM ON PAIN? I THINK IT'S PRETTY OPENS, -- PRETTY OBVIOUS, THERE'S A CHALLENGE HERE, ESPECIALLY A CHALLENGE WHEN YOU THINK ABOUT CHRONIC PAIN. THERE ARE NO OBJECTIVE SIGNATURES OF THE TRANSITION BETWEEN ACUTE AND CHRONIC PAIN, AND THAT IS ONE OF THE SPECIFIC GAPS THAT THIS PROPOSAL IS BEING AIMED FOR. SO THERE ARE A LOT OF THINGS THAT COULD COME OUT OF THAT IF WE WERE ABLE TO IDENTIFY THOSE OBJECTIVE SIGNATURES. AND SOME OF THEM ARE LISTED HERE. IDENTIFICATION OF PATIENTS AT RISK, MAYBE GUIDE PAIN PREVENTION PLANS, I DON'T KNOW, AND GETTING BACK TO THINGS THAT WALTER WAS TALKING ABOUT IN THE BEGINNING, IDENTIFYING MOLECULES THAT MIGHT BE TARGETS FOR NEW DRUGS OR LOTS OF OTHER THINGS WE CAN IMAGINE. SO WHY A COMMON FUND TRANS-NIH PROGRAM? OBVIOUSLY IT'S SOMETHING THAT CUTS ACROSS ALL THE DISEASE SPECTRUMS. WHAT I THINK MIGHT BE DIFFERENT AND A LITTLE BIT UNIQUE HERE, WE'RE TRYING TO PULL IN SCIENTISTS FROM MANY DIFFERENT AREAS OF RESEARCH TO BRING IN SOME DIFFERENT TECHNOLOGIES. SO DIFFERENT OMICS THAT YOU MIGHT ENVISION, PROTEOMICS, ET CETERA. NEUROIMAGING IS HUGE IN THIS PROPOSAL, SENSORY TESTING, PSYCHOSOCIAL TESTING, METABOLOMICS, THINGS THAT WOULD NEED EXPERTISE FROM ACROSS THE NIH TO MAKE SURE THIS HAPPENS. ONE OF THE THINGS THAT'S REQUIRED BEFORE YOU EVEN THINK ABOUT A COMMON FUND PROGRAM IS YOU ALL ARE ON THE SECOND PAGE, I SHOULD HAVE FLIPPED, SORRY. HERE YOU -- MAYBE SOME OF YOU ARE INVOLVED WITH MEETINGS NIDA HOSTED THIS SUMMER, DON'T TRY TO READ ALL THIS BUT SOME OF THE KEY THEMES THAT CAME OUT WERE THAT THERE'S A NEED FOR THESE STANDARDIZED OBJECTIVE BIOMARKERS, AND EXTENSIVE PATIENT PHENOTYPING. SO THE IDEA OF SOME OF THESE OBJECTIVE SCREENS FOCUSED ON TRANSITION FROM ACUTE TO CHRONIC PAIN WAS SOMETHING WE HEARD MULTIPLE TIMES AND IS NOT SOMETHING THAT ONE MIGHT PROPOSE IN AN INDIVIDUAL CLINICAL TRIAL OR OTHER SORT OF NIH PROPOSAL. IT'S MUCH LARGER THAN THAT. THE OTHER THING OF COURSE AS YOU KNOW BETTER THAN I THE FEDERAL RESEARCH PAIN STRATEGY, AND THE LONG-TERM PLANS AND STRATEGIC PLAN YOU'VE WORKED ON. SOME OF THE RECOMMENDATIONS FROM 2017 ARE DIRECTLY -- THINGS WE PULLED DIRECTLY FROM TO DEVELOP THIS PROGRAM, I THINK ESPECIALLY THE SECOND TWO, PROSPECTIVE STUDIES UNDERLYING TRANSITION FROM ACUTE TO CHRONIC PAIN, EXACTLY WHERE THIS IS TARGETED. AND THEN OF COURSE DEVELOPING APPROACHES THAT WOULD INCORPORATE SOME OF THE PRINCIPLES OF PRECISION MEDICINE WHICH WE'RE ALL SO CLOSELY TIED TO IN THE COMMON FUND, TO PREVENT AND MAYBE HOPEFULLY EFFECTIVELY TREAT CHRONIC PAIN. WE'RE AT THE POINT OF CONSIDERING INPUT TO PUT TOGETHER A PROGRAM WE THINK IS THE RIGHT WAY TO ADDRESS THIS. I CAN SAY WE DON'T HAVE A COMMITMENT ON THIS. THIS IS STILL A CONCEPT. AND IT'S SOMETHING WE'RE STILL WORKING ON AND GATHERING INFORMATION AND WE'D LOVE TO HAVE YOUR FEEDBACK ON. WE RECOGNIZE SOME THINGS WILL BE DIFFICULT, PROBABLY THE VERY FIRST ONE I'M GOING TO DESCRIBE HERE. SO WE MIGHT ENVISION A SORT OF CLINICAL TRIAL, AND THAT'S IN THE NEW LINGO, BUT A CLINICAL TRIAL TO OBJECTIVELY -- TO IDENTIFY OBJECTIVE SIGNATURES SUCH THAT I MENTIONED BEFORE. GENETIC SIGNATURES, PERHAPS IMAGING, MOLECULAR, BIOCHEMICAL, METABOLOMIC, ET CETERA, SIGNATURES THAT WOULD ASSOCIATE WITH THE TRANSITION FROM ACUTE TO CHRONIC PAIN. SO THE LARGE DELIVERABLE OF THIS WOULD BE A DATABASE. A DATABASE FOR THE COMMUNITY TO BE ABLE TO ACCESS AND OTHER PEOPLE WOULD DO RESEARCH ON TO TRY TO PULL EVEN MORE INFORMATION OUT OF THIS. I CAN SAY THAT THAT'S SOMETHING -- I DIDN'T SAY BEFORE BUT ONE OF THE THINGS THAT THE COMMON FUND TRIES TO DO IS DELIVER THINGS TO THE COMMUNITY SUCH THAT THE MONEY DOES A LOT MORE THAN JUST BENEFIT THE INDIVIDUALS THAT GET THE GRANTS. THEY ARE BUILDING RESOURCES FOR THE REST OF THE COMMUNITY TO USE, AND, YOU KNOW, TRY TO ANSWER EVEN MORE QUESTIONS, THEY CAN COMPARE THEIR OWN DATA TO IT, ET CETERA. SO THE PIE IN THE SKY IDEA WOULD BE TO RECRUIT PATIENTS WITH A CLEAR T-0 PAIN EVENT, WHICH WE KNOW IS ALMOST IMPOSSIBLE. WE'D HAVE TO DEFINE THAT WELL. OH, GOOD, HE'S SAYING THAT'S NOT IMPOSSIBLE. THAT'S GOOD. >> (INAUDIBLE). >> I KNOW, EXACTLY, RIGHT. BUT THE IDEA WE WOULD BE ABLE TO IDENTIFY SOMETHING THAT WOULD BE CLEARLY ACUTE PAIN INSTANCE AND THEN A TREATMENT AND THEN FOLLOW THOSE FOLKS, DO THEY TRANSITION OR NOT, AND PHENOTYPE THEM ALONG THE WAY. PERHAPS A T-0, SIX MONTHS, MAYBE ONCE IN BETWEEN. IT DEPENDS. REMEMBER THIS HAS TO FIT IN THE FIVE YEAR, PERHAPS LONGER, AS LONG AS FIVE YEARS, BUT USUALLY FIVE YEARS AND THINK ABOUT A SECOND -- AN EXTENSION MAYBE. SO WE WOULD ADDRESS -- WE WOULD LOOK AT ALL THE VARIOUS FACTORS HERE I HAVE LISTED. CLINICAL RECORDS, PSYCHOSOCIAL, PSYCHOPHYSICAL ASSESSMENTS, NEUROIMAGING, AND THEN DEFINITELY DIFFERENT KINDS OF OMIC PHENOTYPING, AND I MENTIONED BEFORE MAYBE GENOMICS, CERTAINLY METABOLOMICS, PROTEOMICS, YOU'VE ALREADY HEARD ABOUT microRNAs THAT HAVE BEEN IDENTIFIED. WE HAVE A WHOLE PROGRAM ON EXTRACELLULAR RNA COMMUNICATION, HUGE DATABASES OF SECRETED RNAs, SOMETHING WE WOULD BE INTERESTED IN COMPARING AND ASSESSING AS WELL. SO ACKNOWLEDGING THAT SIX MONTHS MAY NOT BE IDEAL BUT OBVIOUSLY WE HAVE LIMITS WITH HOW MUCH TIME WE CAN USE AND THERE CERTAINLY WILL BE SOME PEOPLE THAT TRANSITION BY SIX MONTHS. THE PROPOSAL IS TO MAYBE HAVE A PARALLEL CLINICAL TRIAL THAT WOULD BE ALSO DISCOVERY FOCUSED, FOLKS WOULD BE ASSESSED IN THE SAME WAY, THEY WOULD HAVE HAD THE SAME T-0 EVENT, WHATEVER THAT MIGHT BE, IT COULD HAVE BEEN A SURGERY, COULD BE AN INJURY OR TRAUMA, BUT THE PEOPLE IN THIS PARALLEL STUDY WOULD HAVE THAT SAME EVENT BUT WE WOULD -- THEY HAD ALREADY TRANSITIONED TO CHRONIC PAIN SO THEY MAY HAVE HAD THAT EVENT TWO, THREE, TEN, TWENTY YEARS AGO AND WE WOULD BE ASSESSING THEM AT ONE TIME POINT WHICH IS THE NOW, RIGHT? WHEN THEY ARE THE CHRONIC PAIN PERSON. SO THEY WOULD HAVE HAD THAT CHRONIC PAIN GREATER THAN A YEAR AND THEN ASSESS THE SAME FACTORS SO YOU CAN COMPARE AND CONTRAST. AT THE SAME TIME THOSE WOULD BE THE TWO CLINICAL TRIALS, AND AT THE SAME TIME THERE WOULD BE A DATA COORDINATION ANALYSIS CENTER TO IDENTIFY VARIOUS SIGNATURES THAT COULD EITHER PREDICT TRANSITION TO CHRONIC PAIN, OR RESILIENCE TO CHRONIC PAIN. AND THEN ALSO SIGNATURES THAT WOULD DEFINE ESTABLISHED CHRONIC PAIN. THERE MAY BE, ALTHOUGH IT WOULDN'T BE A MAJOR FOCUS, BUT THERE MAY BE SIGNATURES THAT PREDICT THE EFFICACY OF THE PAIN MANAGEMENT STRATEGIES, THAT HAVE CONTROL OVER.HING WE WOULD- WE WOULD LET THE PEOPLE BE TREATED HOWEVER THEY WOULD BE TREATED IN THE SITUATION THAT THEY ARE IN. SO, AGAIN, THE CLINICAL PROJECTS HERE, THESE ARE SOME OF THE REALLY TRICKY THINGS, THE APPLICANTS THEMSELVES WE WOULD LOOK TO THEM TO JUSTIFY WHATEVER THAT ACUTE PAIN EVENT MIGHT BE. THEY WOULD HAVE TO TELL US HOW THEY WOULD RECRUIT PEOPLE, HOW MANY PEOPLE THEY COULD GET, ET CETERA, WHAT THEY HAVE DONE IN THE PAST. AND WHAT THEY WOULD PROPOSE. AND AS ANY PROJECT, IT WOULD BE PEER REVIEWED TO DECIDE WHICH WOULD BE REALLY THE BEST WAY TO DO THIS. THEY WOULD -- OFTEN THE WAY WE DO THIS, I CITED THE EXERCISE PROGRAM, IS WE BRING THE AWARDEES, THE FOLKS THAT MAKE IT THROUGH PEER REVIEW, TOGETHER FOR AN INITIAL PLANNING YEAR. IN WHICH THERE'S NO RECRUITENT YET BUT THEY BANG OUT ALL THE DETAILS AND WE FOUND THIS TO BE INCREDIBLY IMPORTANT BECAUSE YOU HAVE DIFFERENT KINDS OF SCIENTISTS THAT DON'T UNDERSTAND WHAT THE OTHER PEOPLE DO AND THEY NEED TO TALK. AND THEY NEED TO UNDERSTAND HOW THIS WILL WORK AND HOW IT WILL BE SET UP. AND, YOU KNOW, A LOT OF THAT TAKES TIME. THAT'S THE CHAOS PHASE OF IT PERHAPS. EVEN THIS ONE YEAR WOULD BE VERY GOAL AND MILESTONE DRIVEN SUCH THAT THEY WOULD BE EXPECTED TO COME UP WITH VARIOUS DECISIONS AT CERTAIN TIME POINTS, OR IT WOULDN'T MOVE FORWARD. SO THERE ARE THE VARIOUS THINGS THAT THEY WOULD COMPARE. HOW THEY ARE GOING TO MANAGE THE PAIN, WHAT THEY ARE GOING TO MEASURE, HOW THEY ARE GOING TO ASSESS THE PSYCHOSOCIAL ASPECTS THINGS, WHAT IMAGING PROTOCOLS ARE AND THEY WILL START TO TALK ABOUT HOW THEY ARE GOING TO COLLECT VARIOUS SAMPLES, EVERYTHING HAS TO BE STANDARDIZED. WE HAVE OTHER PROGRAMS ALREADY LIKE THIS, LIKE THE EXERCISE ONE IN WHICH THEY HAVE BANGED OUT A LOT OF DETAILS. WE WOULD LEAN HEAVILY ON THEM, BRING SOME OF THEM IN TO TALK TO THIS GROUP AN GET ADVICE AND HOW WOULD YOU DO THIS. WELL, THIS IS HOW WE'RE DOING IT. HOW IS PAIN DIFFERENT THAN EXERCISE? LET'S TALK ABOUT THAT AND WHAT IS DIFFERENT. ONE OF THE BIG DIFFERENCES HERE WOULD BE THE NEUROIMAGING PART. AND I THINK THAT'S GOING TO BE SOMETHING THAT'S GOING TO BE IMPORTANT. IT'S GOING TO BE NOVEL AND TRANSFORMATIVE. AND THAT'S PART OF WHAT MAKES THIS HOPEFULLY WORK. SO, YOU KNOW, WE'VE DIAGRAMMED THIS OUT HERE JUST TO MAKE IT A LITTLE BIT EASIER. I'M NOT SAYING THIS IS THE WHICH IT'S GOING TO BE, REMEMBER. BUT THERE MIGHT BE A CLINICAL COORDINATING CENTER THAT WOULD THEN COORDINATE THE THREE SITES, MAYBE THREE, WE DON'T KNOW YET, SITES WHERE THE FOLKS WOULD BE RECRUITED INTO THE STUDY. THERE WOULD BE A DATA RESOURCE CENTER THAT WOULD DO ALL THE COORDINATION. COORDINATE ALL THE DATA STANDARDS, AFTER THINGS ARE DONE ONCE WE HAVE THE DATA, IT HAS TO BE PUSHED OUT TO THE COMMUNITY SO THAT OTHERS USE IT. SO THAT IT'S BROADLY TAKEN UP AND COMPARED TO AND USED. THEY WOULD DO THE INTEGRATION OF THE DATA. THERE WOULD BE THESE ANALYSIS SITES, AND THERE MIGHT BE MORE THAN -- I MEAN THERE MIGHT BE SIX SITES, MAYBE LESS, MAYBE MORE, SOME SITES MY MIGHT DO MORE THAN ONE THING. THIS IS IN PENCIL. THESE SITES WOULD GENERATE AND DO INITIAL QUALITY CONTROL SORT OF ANALYSIS OF THE DATA. THEY WOULD HAVE TO DEPOSIT EVERYTHING INTO PUBLIC DATABASES THAT WOULD THEN BE INTEGRATED OVER HERE, WITH THE DATA RESOURCE CENTER. AND ALL OF THIS CLINICAL COORDINATING CENTER WOULD COORDINATE ALL OF THE MEETINGS AND CONVERSATIONS AND EVERYTHING THAT NEEDS TO HAPPEN AND THEY WOULD HAVE A VERY TIGHT CONTROL OVER WHAT'S HAPPENING WITH THE GOALS AND MILESTONES THAT THE NIH IS VERY INVOLVED IN. AS I SAID, THESE WOULD BE COOPERATIVE AGREEMENTS SUCH THAT NIH SITS ON THE STEERING COMMITTEE AND BRINGS IN PEOPLE FROM THE COMMUNITY TO SIT ON STARING COMMITTEES AND ADVISORY BOARDS. WE ALWAYS HAVE PROGRAM CONSULTANTS THAT ARE EXTERNAL TO THE AWARDEES, SO WE TRY TO TAKE IN ALL POINTS OF THE COMMUNITY& THAT SHOULD WEIGH IN ON THESE THINGS. SO AGAIN THIS IS VERY SKETCHED OUT IN PENCIL. THIS IS ONE WAY TO APPROACH THINGS. THIS IS RATHER LARGE. SO WHAT WE ARE REALLY THINKING SERIOUSLY ABOUT BEFORE WE WOULD LAUNCH THIS IS MAYBE THINK ABOUT HOW WE COULD PILOT THIS ON A SMALLER SCALE TO MAKE SURE IT WOULD WORK BEFORE WE WOULD GO TO SUCH A LARGE PROGRAM LIKE THIS. AND THAT'S THE SORT OF THING WE'RE WRESTLING WITH NOW AND TRYING TO MOVE IT FROM PENCIL INTO PEN IN SOME SORT OF TIMELY MANNER. I CAN'T GIVE YOU A TIME LINE FOR THAT. I JUST WANT TO ACKNOWLEDGE THERE'S BEEN A LOT OF PEOPLE ACROSS THE NIH TALKING ABOUT THIS BUT THERE'S BEEN A SMALLER GROUP THAT'S BEEN TALKING ABOUT THIS PRECISELY, MANY IN THE ROOM, LINDA, DAVE THOMAS, MYSELF, JOHN SATTERLY HAS BEEN A BIG HELP. WE'VE HAD OTHER PEOPLE FROM MY OFFICE, STEPHANIE AND REBECCA FROM OSC THAT HAVE ALSO BEEN WORKING WITH JUST LITERATURE REVIEWS AND NIH PORTFOLIO ANALYSIS, TRYING TO FIGURE OUT WHAT WE'RE ALREADY DOING AND HOW THAT COULD INFORM WHAT WE'RE TRYING TO DO. AND SO ON. SO I'M HAPPY TO TAKE QUESTIONS. AND WE WOULD REALLY LIKE TO HEAR FROM YOU ABOUT WHAT YOU SEE AS MAYBE DEAL BREAKERS HERE, MAYBE GEMS WE SHOULD POLISH MORE AND BRING TO THE FRONT. AND THAT'S WHAT I HAVE FOR YOU. YES? >> IT'S INTERESTING BECAUSE WE'RE WORKING ON THIS RIGHT NOW IN A PROGRAM WE CALL PASTEUR BIOBANK, GETTING BIOIMAGES FROM OUR SOLDIERS, MAYBE WILL HAVE THE ZERO TIME POINT THAT YOU'RE TALKING ABOUT. WE HAVEN'T GOTTEN STARTED YET. WE'RE WORKING THROUGH THE UNIFORM SERVICES UNIVERSITY WORKING THROUGH PROTOCOLS. WOULD LOVE TO COMPARE NOTES AS WE MOVE FORWARD. >> I SHOULD HAVE MENTIONED PROMIS WAS ONE OF OUR PROGRAMS THAT WASN'T ON THE BUBBLE DIAGRAM, RETIRED A FEW YEARS AGO, SOMETHING WE WOULD LEVERAGE AS WELL. THANK YOU. YES? >> I JUST LIKE TO NOTE THAT, YOU KNOW, NIDCR HAS FUNDED AN ALMOST NOW 15-YEAR STUDY OPERA, WHICH USE AS PROSPECTIVE STUDY DESIGN WITH THE NESTA CASE CONTROL DR. FILLINGEN HAVE BEEN WITH FOR MANY YEARS, THE MODEL SIMILAR TO WHAT YOU'VE GONE THROUGH, I'M SURE THE OPERA TEAM WOULD AVAIL ITSELF TO HELP YOU WITH LESSONS LEARNED AFTER OUR NEARLY 17-YEAR HISTORY IN THE PROCESS. >> THANK YOU. WE'VE LOOKED TO THAT PROGRAM QUITE A BIT FOR GUIDANCE AND TRYING TO PUT THIS TOGETHER. >> OUR SISTER PROGRAM, THE MAPP PROGRAM AS WELL. OVER THE LAST DECADE OR SO THERE ARE A LOT OF LESSONS LEARNED HERE THAT WE CAN ASSIST YOU. >> THANK YOU. THAT'S REALLY HELPFUL. YES? >> THIS IS VERY PROMISING. I'M WONDERING ARE YOU CONSIDERING OTHER PROJECTS AS WELL OR IS THIS -- HOW FAR ALONG ARE YOU IN SETTLING ON PERHAPS DOING THIS? >> CONSIDERING OTHER PROJECTS, YOU MEAN IN THE AREA OF PAIN? >> NO, I MEAN IN OTHER WORDS IS THIS IN COMPETITION WITH OTHER PROJECTS OR DO YOU JUST LOOK DOWN ONE PATH AND . >> I SEE. WELL, THERE ARE ALWAYS OTHER PROJECTS THAT ARE GOING THROUGH THE COMMON FUND. SO, YES, THERE ARE OTHER THINGS THAT WE'RE THINKING OF STARTING IN BOTH FISCAL YEAR 18 AND 19, THERE ARE THINGS THAT WILL COME UP FOR -- AS I MENTIONED WE CAN SOMETIMES HAVE A STAGE 2 AND EXTEND SOMETHING. SO THERE ARE A COUPLE OTHER THINGS THAT, YOU KNOW, ARE IN THE WORKS, BUT THERE'S ALWAYS COMPETITION, YES. >> WHEN WILL WE KNOW WHETHER YOU WOULD GO FORWARD WITH THIS? >> I DON'T KNOW WHEN EXACTLY WHEN WE'LL KNOW WHEN WE'LL HAVE THIS BE THE FINAL THING SUBMITTED. WE TALKED ABOUT FISCAL YEAR 18. I DON'T SEE THAT BEING FEASIBLE BUT MAYBE THAT'S JUST ME. LINDA IS MORE OPTISTIC -- OPTIMISTIC THAN I AM BUT MAYBE FISCAL YEAR 19. SORRY, LINDA. >> OPTIMISTIC BUT NOT REALISTIC PERHAPS. >> YES? >> I THINK THIS MIGHT BE A VERY GOOD OPPORTUNITY TO REVISIT THE RELIANCE UPON RCTs AND META-ANALYSES, EXCLUSIVELY OR LET'S SAY THE HEAVYWEIGHTING THAT'S BEEN GIVEN TO THEM IN LIGHT OF INCREASING INTEREST IN ALTERNATIVE MEANS OF DATA GATHERING, THAT MIGHT FIT BETTER WITH HOW DATA IS GATHERED NOW SUCH AS ELECTRONIC HEALTH RECORD, BIG DATA, SO THAT THE SOURCES OF INPUT INTO THE HYPOTHESES AND OUTCOMES OF THESE PROPOSALS MIGHT LEVERAGE ON WHAT'S BEEN TERMED LIKE THOMAS FRIEDEN'S REVIEW IN THE NEW ENGLAND JOURNAL LAST MONTH, BEYOND RCTs, NOT THAT RCTs SHOULD BE ABANDONED BY ANY MEANS BUT I THINK THIS IS AN OPPORTUNITY TO LEVERAGE ON HOW THE PROCESS OF HEALTH CARE AND DATA ACQUIRED DURING HEALTH CARE ARE EVOLVING. >> YES, ELECTRONIC HEALTH RECORDS WOULD DEFINITELY BE PART OF THIS. I DON'T KNOW THAT ARTICLE. I CAN LOOK INTO THAT. BUT WE WANT TO LEVERAGE AS MUCH OF THAT AS POSSIBLE, YES. GOOD POINT. >> ANY OTHER QUESTIONS FOR TRISH? THANK YOU. >> THANK YOU FOR LISTENING. >> I THINK WE APPRECIATE THIS, REALLY EXCITING IF WE CAN KIND OF GALVANIZE ALL THE INSTITUTES ON A PROJECT LIKE THIS AND THEN I THINK AS DAN MENTIONED, TRYING TO REACH OUT TO SEE IF WE CAN EXPAND IT WITH LARGE NUMBERS ACROSS MULTIPLE DIFFERENT HEALTH CARE SYSTEMS EVEN. TRY AND GET, YOU KNOW, THE COMMON FUND IDEA IS TO DEVELOP A TOOL OR DATA BASE THAT'S GOING TO BE HELPFUL MOVING FORWARD. BUT, YOU KNOW, IF WE GET LUCKY, WE -- IF WE COULD FIND SIGNATURES WHICH PREDICT WHICH PERSONS ARE AT HIGHEST RISK IN ANY GIVEN SITUATION, THAT I WOULD THINK WOULD LEAD VERY QUICKLY TO SOME TYPE OF PROGRAM TO REDUCE THEIR RISK GOING FORWARD. IF YOU CAN DEFINE THE RISK THEN YOU CAN LOOK AND SEE IF SOMETHING REDUCES THE RISK. AND ON THE OUTSIDE CHANCE WE FIND SOME BIOLOGICAL, YOU KNOW, CHARACTERISTIC OF THOSE PEOPLE THAT ARE THEN RESPONSIVE TO, YOU KNOW, A PHARMACOLOGIC INTERVENTION OR NON-PHARMACOLOGIC INTERVENTION, THAT GIVES US A WHOLE NEW AREA TO EXPLORE TRYING TO PREVENT CHRONIC PAIN. SO THE ASPIRATIONS ARE QUITE IMPORTANT IF WE CAN DELIVER ON THEM FOR SURE. SO I GUESS THE -- YOU KNOW, THE ISSUES ARE BARBARA, HERE, THE ISSUES THAT HAVE COME UP, WHAT POPULATION DO YOU PICK? IF YOU PICK A POPULATION 2% OF THE PEOPLE GO ON TO CHRONIC PAIN, FOR EVERY 100 PEOPLE YOU RECRUIT YOU GET 2 TO FOLLOW, SO WE HAVE TO CERTAINLY DEFINE THE POPULATION WELL SO THAT THE CHANCES OF SEEING SOMETHING IN THE EARLY PHASE ARE HIGHER, WHICH GETS US TO THE PROBLEM OF& THE PILOT. THE PILOTS, IF YOU PICK THE WRONG POPULATION YOU COULD STRIKE OUT ON THE PILOT. SO THE PILOTS, WE THINK WE NEED A POPULATION THAT WE THINK IS GOING TO BE HIGHLY INFORMATIVE JUST TO START THINGS OFF, GET OUR SENSE OF VALUE DOWN AND THEN WE CAN GENERALIZE OUT. SO PEOPLE HAVE INFORMATION ON WHAT TYPE OF PATIENT SITUATIONS MIGHT BE BEST. AND DATA ON THAT. WE'D REALLY LIKE TO HEAR IT. THERE ARE DATA ON WHAT THE RATE OF TRANSITION IS, BUT THE DATA CAN SOMETIMES SAVE BETWEEN 20 AND 80% SO THERE'S THESE TREMENDUS VARIABILITY AND ESTIMATES THAT WE'VE BEEN LOOKING AT. SO THAT'S OUR FIRST STEP IF WE CAN GET SOME GOOD DATA FROM FOLKS, WHAT THEY THINK THE ESTIMATES ARE IN A PARTICULAR SITUATION, THAT WOULD BE REAL HELPFUL. YEAH? >> THERE ARE SOME PATIENT POPULATIONS THAT ARE VERY CLASSIC I THINK FOR BEING AT RISK FOR ACUTE TO CHRONIC PAIN TRANSITION, SOME POST-SURGICAL TYPES OF SETTINGS. DOES OPERA LEND ITSELF TO HELPING DETERMINE WHICH ARE THE MORE LIKELY POPULATIONS? >> I THINK OPERA HAS IDENTIFIED A NUMBER OF WAYS OF STRATIFYING PATIENTS. PRIMARILY STRATIFYING FOR ACUTE ONSET TO TMD, MUSCULOSKELETAL PAIN CONDITION BUT MANY VARIABLES IDENTIFIED IN OPERA THERE ARE SMALL STUDIES IN THE PERIOPERATIVE SPACE THAT ARE IDENTIFYING SOME OF SIMILAR IF NOT IDENTICAL FACTORS. WE THINK WHAT WE'VE IDENTIFIED IN OPERA AS RISK TRAJECTORIES BASED ON PHENOTYPE AND BY GRAPHING PHENOTYPES INTO SUBGROUPS THROUGH CLUSTER ANALYSIS AND THEN LOOKING AT THESE MOLECULAR SIGNATURES UNDER THESE CLUSTERS, THIS WILL HELP INFORM PERIOPERATIVE STUDIES. I THINK THERE WILL BE A DIRECT TRANSLATION FOR THE MOST PART WHAT WE'RE SEEING IN OPERA THAT'S PREDICTING TRAJECTORIES THAT WILL HAVE IMPLICATION FOR DESIGN HYPOTHESES IN THE PERIOPERATIVE SPACE. >> AND I MIGHT ADD IT'S IMPORTANT TO CHARACTERIZE SORT OF THE TEMPORAL DYNAMICS OF THIS TRANSITION AND AVOID THE NAIVE VIEW THERE'S AN ON/OFF SWITCH HERE, TRANSITION TO VARIOUS STAGES OF CHRONIC PAIN. SOME PEOPLE HAVE PAIN AT SIX MONTHS DON'T HAVE PAIN THEREAFTER. SOME PEOPLE HAVE PAIN AT VARIOUS POINTS OF ASCERTAINMENT, AND SUBSEQUENT POINTS WILL NOT, SO THE SYSTEM THAT HAS ENOUGH TEMPORAL RESOLUTION TO CAPTURE THAT COMPLEX TRAJECTORY OF PAIN IS IMPORTANT. AND I KNOW WE'VE OBSERVED IN OPERA THAT WHEN YOU CAREFULLY MONITOR FOR ONSET OF PAIN, YOU FIND PAIN. WHEN YOU WAIT FOR PAIN TO COME TO YOU, YOU HAVE MUCH LOWER ESTIMATES OF RISK AND PREVALENCE. >> IN TERMS OF THAT, BARBARA WANTS TO THINK ABOUT QUESTIONS THAT SHE NEEDS ANSWERED BUT FOR PILOT WAITING TWO YEARS WOULD BE OFF THE TABLE. WE NEED TO DESIGN MORE AT THE SIX-MONTH LEVEL, WHAT ADVICE YOU COULD GIVE US ON WHAT PAIN POPULATION OR WHAT ASSAY, YOU KNOW, KNOWING IT'S NOT GOING TO BE PREDICTIVE OF TWO YEARS BUT FOR THE PILOT THAT'S THE KIND OF THING WE NEED MORE SHORT-TERM INFO. >> I WOULD SUGGESTING THAT A -- SUGGEST A SIX-MONTH TIME POINT WOULD BE SUFFICIENT FOR PILOT DATA, AND LONG TERM WOULD BE ONE YEAR, TWO YEAR. I THINK BY CURRENT INTERNATIONAL GUIDELINES FOR CHRONIC PAIN, THAT SIX MONTHS WOULD BE SUFFICIENT TO LOOK FOR PERSISTENCE OR CHRONICITY POST EVENT. >> WALTER, JUST IN A RANGE OF PILOTS THAT ARE ALREADY UNDERWAY, WORK BEING DONE IN EMERGENCY MEDICINE DOWN AT UNC BY SAM McLAIN'S GROUP LOOKING AT POST-AUTOMOBILE ACCIDENT AND VICTIMS OF SEXUAL ASSAULT, AND THEY ARE COLLECTING microRNA DATA. SO IT WOULD BE WORTH MINING THAT TO SEE LESSONS LEARNED. >> I HAVE TO WONDER, I MEAN, I UNDERSTAND SELECTION OF POPULATIONS BUT I HAVE TO WONDER DO YOU LOOK AT THEIR LIFESTYLES AND FAMILY INTERVENTIONS? BECAUSE THAT QUITE OFTEN HAS AN IMPACT ON HOW WELL SOMEONE'S GOING TO DO, IF THEY ARE GOING TO FALL IN THE CHRONIC PAIN SPACE. THAT'S I THINK REALLY SOMETHING THAT NEEDS TO BE LOOKED AT. >> SO THIS GOES BACK TO, YOU KNOW, I THINK REQUEST TO THE COMMUNITY THAT WE DEVELOP SURVEYS THAT REALLY TAP INTO ENVIRONMENTAL EXPOSURES ACROSS THE LIFESPAN. THAT THAT'S AN AREA THAT WE'VE -- WE'RE PROBABLY LACKING OUR REALLY GOOD METRICS, GOOD MEASURES OF ENVIRONMENTAL EXPOSURES THAT CAN DRIVE BOTH ONSET AND PERSISTENCE IN THE OMICS UNDERLYING THOSE. SO I THINK THERE CONTINUES TO BE A NEED FOR THE DEVELOPMENT OF SURVEYS THAT TAP INTO ENVIRONMENTAL HISTORY AND EXPOSURES. >> SO AS I'M LISTENING TO THIS CONVERSATION, AND CONCERNS ABOUT DATABASES AND BIG DATA BASES WHAT DO WE DO WITH THEM, ON THE OTHER HAND I'M HEARING INFORMATION THAT WOULD BE GREAT IF COLLECTED IN A GROUP FROM YOU, IF IT WAS COLLECTED SOMEWHERE AND IF ANYONE IS CONSIDERING PUTTING ALL THIS INFORMATION THAT'S HERE IN AN ACCESS PLACE SO THAT WE COULD SEE THE COMMONALITIES AND PULL THEM OUT NOW THAT YOU HAVE THIS SOFTWARE THAT WE CAN DO THESE THINGS WITH. IS ANYBODY DOING THAT? >> I DON'T KNOW IF LINDA WANTS TO COMMENT ON THAT BUT ALL OF THE OPERA ONE FINDINGS, THE VAST MAJORITY, EXIST IN dbGAP. AND WE ARE WORKING ON DATA THAT WAS COLLECTED FOR NINDS PROGRAM PROJECT, THAT DATA IS BEING WORKED YOU THE, AND THAT WILL BECOME MERGED, I HOPE, WITH SOME OF THE ORDER OF MAGNITUDE A ONE SO WE ARE MAKING AVAILABLE SUCH DATA AND I KNOW THE PAIN CONSORTIUM HAS INTEREST IN DEVELOPING THE CONCEPT OF COMMON DATA ELEMENTS AND DEVELOPING A MECHANISM BY WHICH DATABASES CAN BE BROUGHT TOGETHER THAT COULD BE MINED BY THE COMMUNITY. >> TO ADDRESS YOUR QUESTION, THERE'S BEEN A LOT OF EFFORT TO MAKE THE DATA, AS BILL MENTIONED, PUBLIC ON SOME BIGGER STUDIES THAT HAVE ALREADY BEEN DONE. HE'S OBVIOUSLY MAKING BIG CONTRIBUTION THERE. A LOT OF DIFFICULTY PULLING TOGETHER WHAT'S BEEN STANDARDIZED, WHAT'S BEEN COLLECTED, AND SO PUTTING IT ALL INTO A BIG POOL OF DATA, THE COMPLICATION COMES IN THAT DIFFERENT FORMS ARE USED, DIFFERENT PROTOCOLS ARE USED. AND ONE OF THE THINGS THAT WOULD DO DURING THE PLANNING YEAR OF THE CONCEPT THAT WAS PRESENTED WOULD BE TO MAKE SURE THAT ACROSS ALL THE SITES AND ALL THE COHORTS THAT ALL THOSE THINGS WERE COMPLETELY STANDARDIZED. THIS HAS BEEN A BIG PIECE OF CONVERSATION AND WILL CONTINUE TO BE IF HOPEFULLY THE PROPOSAL MOVES FORWARD. THE OTHER THING, I THINK SOME REALLY GOOD SUGGESTIONS HAVE COME UP ABOUT ACROSS THE TABLE THIS MORNING ABOUT SOME STUDIES THAT HAVE BEEN ONGOING, SOME DATA THAT'S ALREADY AVAILABLE. AND WE HAVE BEEN THROUGH TRISH'S OFFICE PULLING TOGETHER A PRETTY COMPREHENSIVE SEARCH OF THE LITERATURE TO MAKE SURE THAT WE'VE GOT ALL THOSE PIECES IN PLACE THAT CAN CONTRIBUTE TO HOW THIS IS PUT TOGETHER. MAKE SURE THAT WE'RE USING THE AVAILABLE KNOWLEDGE AND SMALLER STUDIES THAT HAVE ALREADY BEEN DONE, BECAUSE CLEARLY WE'RE NOT STARTING FROM THE POINT ZERO. THERE HAS BEEN A LOT THAT WILL HELP US DEVELOP AND STRUCTURE A BIG PROJECT LIKE THIS. CINDY? >> I'M WONDERING IS THERE ANY BUDGETARY NUMBERS ASSIGNED TO SOMETHING LIKE THIS? DO YOU HAVE ANY -- YOU SAY THESE ARE BIG PROJECTS WHAT ARE WE TALKING ABOUT IN TERMS OF SCALE? >> IT REALLY DEPENDS ON THE SIZE OF COHORT THAT'S NEEDED. THIS IS CLEARLY A PROJECT THAT WOULD BE MORE THAN ONE INSTITUTE OR A FEW INSTITUTES, WHERE THE PAIN CONSORTIUM COULD MANAGE. I DON'T KNOW WHAT THE WHOLE COMMON FUND PROJECT BUDGET IS BUT BASICALLY WE WERE TOLD AS WE PUT THE BUDGET TOGETHER TO ASK FOR WHAT YOU NEED TO DO THE PROJECT APPROPRIATELY. SO MORE TO COME ON THAT HOPEFULLY AS WE MOVE INTO THE FUTURE. THANKS VERY MUCH. BEFORE WE LEAVE THIS TOPIC AND MOVE INTO THE FEDERAL PAIN RESEARCH STRATEGY, I DID WANT TO REMIND YOU WE'RE GOING TO STEP BACK IN TIME FOR A SECOND HERE. THE 2010 AFFORDABLE CARE ACT HAD THE PAIN CARE BILL EMBEDDED IN IT, AND VERY SPECIFIC RECOMMENDATIONS, THANKS I THINK TO SOME OF YOU WHO ARE AT THE TABLE TO MAKE SURE THAT BILL GOT INTO THE AFFORDABLE CARE ACT, FOR THE PAIN CONSORTIUM, OBVIOUS TO ESTABLISH IPRCC, BUT THE PAIN CONSORTIUM WAS TOLD EVERY NEAR WE NEEDED TO PULL TOGETHER AND SUBMIT A PROPOSAL NOT COMMON FUND. WE WORKED HARD OVER THE YEARS TO DO THAT AND HAVE BEEN ABLE TO TAP INTO SOME PROGRAMS THAT WERE EXISTING AS BIGGER PROGRAMS, NOT PAIN SPECIFIC, FOR EXAMPLE PRAGMATIC TRIALS FUNDED THAT WERE SPECIFIC TO PAIN ON THE HEALTH CARE SYSTEMS COLLABORATORY WHICH IS A BIG COMMON FUND PROJECT. AND THROUGH SPARC THEY ARE FUNDED THROUGH THE COMMON FUND PROGRAMS. THE OFFICE OF STRATEGIC PLANNING SAID WE WOULD LIKE TO SEE A PROPOSAL PUT TOGETHER AND HELPED US SORT OF WITH SOME THOUGHTS THAT THEY HAD ON HOW THIS KIND OF CONCEPT WOULD FIT INTO SOME OF THE OTHER PROJECTS THAT ARE MOVING FORWARD ACROSS THE NIH. WALTER AND NORA AND DR. COLLINS WILL TALK ABOUT THE PUBLIC/PRIVATE PARTNERSHIP THIS AFTERNOON THAT THEY ARE WORKING ON WITH NIH AND THE PHARMACEUTICAL INDUSTRY. AND I THINK YOU'LL KIND OF SEE HOW ALL OF THESE THINGS ARE GOING TO INTERSECT AND WILL HELP ONE ANOTHER MOVE THE MAIN RESEARCH FIELD FORWARD. SO THIS IS HERE JUST AS SORT OF A LITTLE PIECE OF BACKGROUND TO REMIND YOU OF THE COMMON FUND AND ITS CONNECTION TO PAIN. SO LET'S SWITCH HERE TO THE FEDERAL PAIN RESEARCH STRATEGY. THIS IS GOING TO COME UP AGAIN SO I WILL COME TO IT. ALLAN I THINK IS ON THE PHONE BUT PROBABLY MUTED AND IF YOU COULD UNMUTE AND LET US KNOW IF THAT'S INDEED THE CASE, ALLAN? GIVE HIM A SECOND. SILENCE IS NOT ALWAYS GOOD. HE WAS ON. WE KNOW HE WAS HERE A FEW MINUTES AGO. ALLAN, IF YOU COULD COMMUTE YOUR COMPUTER SO WE DON'T HEAR OURSELVES AT THE MEETING THROUGH YOUR VIDEOCAST, BUT UNMUTE YOUR PHONE AND COME BACK TO US, THAT WOULD BE GREAT. MEANTIME I'M GOING TO GET STARTED. GIVE ME A SHOUT IF YOU GET BACK ON. ALLAN WANTED TO BE HERE TODAY, AS YOU ALL KNOW HE CO-CHAIRED THE STEERING COMMITTEE THAT HELPED TO COORDINATE AND OVERSEE THE DEVELOPMENT OF THE FEDERAL PAIN RESEARCH STRATEGY. HE'S PUT IN AN INCREDIBLE AMOUNT OF TIME AND EFFORT. >> YES, I'M HERE. >> THANK YOU, ALLAN. HI, GOOD MORNING. >> GOOD MORNING. >> INTO THIS. AND ALLAN HAS SOME MAJOR COMMITMENTS TODAY AND ON TOP OF THAT HE VERY UNFORTUNATELY LOST HIS HOME, HIS SECOND HOME, IN THE NAPA FIRES. SO I THINK HE'S GOT A LOT ON HIS PLATE NOW AND SO ALLAN, THANKS FOR BEING HERE. I'LL GIVE YOU A SECOND TO SAY HI. >> WE KNEW HE WAS >> I'M HERE. >> IF YOU'VE GOT YOUR COMPUTER ON CAN YOU TURN THE VOLUME OFF. WE'RE HEARING SOMETHING IN THE BACKGROUND. >> IS THAT BETTER? >> YES, IT IS. THANK YOU. OKAY. SO ALLAN WAS GOING TO START THE PRESENTATION AND I WAS GOING TO PICK UP THE SECOND HALF BUT IT'S COMPLICATED WHEN HE'S THERE AND WE'RE HERE. SO I WOULD LIKE TO START OFF JUST BY POINTING OUT THE STRONG CONNECTION AND MISSION BETWEEN THE NIH PAIN CONSORTIUM WHICH I THINK ALL OF YOU AT THIS POINT ARE FAMILIAR WITH IN THAT IT IS A TRANS-NIH COLLABORATIVE WHERE MEMBERS FROM NEARLY ALL THE INSTITUTES AND CENTERS ACROSS NIH WORK TOGETHER TO HELP COORDINATE THE PAIN RESEARCH AGENDA AT THE NIH. AND SO THEIR MISSION STATEMENT HAS BEEN AND REMAINS TO BE TO ENHANCE PAIN RESEARCH AND PROMOTE COLLABORATION AMONG RESEARCHERS ACROSS THE NIH INSTITUTES AND CENTERS, THAT HAVE PROGRAMS AND ACTIVITIES ADDRESSING PAIN. THE IPRCC IS A TRANSAGENCY ORGANIZATION, AS YOU ALL CLEARLY KNOW, AND THEIR MISSION IS INCREDIBLY SIMILAR TO THAT OF THE CONSORTIUM EXCEPT AT A MORE BROAD SCALE IN THAT IT INVOLVES ALL THE AGENCIES IN THE DEPARTMENTS THAT SUPPORT PAIN RESEARCH. SO THEIR MISSION IS TO ENHANCE PAIN RESEARCH EFFORTS, PROMOTE COLLABORATION ACROSS THE GOVERNMENT, WITH THE GOALS OF ADVANCING FUNDAMENTAL UNDERSTANDING OF PAIN AND IMPROVING PAIN-RELATED TREATMENT. AND SO BOTH OF THESE ENTITIES WERE VERY INVOLVED IN THE DEVELOPMENT OF NATIONAL PAIN STRATEGY WITH DIFFERENT RESPONSIBILITIES, THE PAIN CONSORTIUM MORE INVOLVED AT THE BEGINNING IN PLAN STAGES BUT CONTINUING TO HAVE REPRESENTATION ON THE WORKING GROUPS THAT DEVELOPED THE RESEARCH PRIORITIES. INTERAGENCY PAIN RESEARCH COORDINATING COMMITTEE, YOU ALL HAVING A HIGH LEVEL OVERSIGHT, AND ASSISTING WITH COORDINATION AND FEEDBACK THROUGHOUT THE PROCESS OF DEVELOPMENT OF THE STRATEGY. SO EVEN THOUGH WE'VE BEEN TOLD MANY TIMES THAT WE DON'T PUT ENOUGH RESEARCH DOLLARS INTO PAIN, IT IS A FAIRLY LARGE AND FAIRLY COMPLEX PORTFOLIO WHEN YOU LOOK ACROSS THE FEDERAL GOVERNMENT. AND SO IT REALLY DOES NEED COORDINATION. IT REALLY DOES NEED STRATEGIC PLANNING TO MAKE SURE THAT IT MOVES FORWARD OPTIMALLY AND EFFICIENTLY AND WE SPEND FEDERAL DOLLARS IN A WAY THAT'S GOING TO BE REALLY EFFECTIVE IN DEVELOPING A GOOD RESEARCH AGENDA THAT WILL SUPPORT QUALITY TREATMENT FOR PEOPLE WITH PAIN. SO QUICKLY HERE, ON THE LEFT SIDE OF THE SLIDE IS AN EXAMPLE OF HOW THE IPRP DATABASE IS SET UP. THIS IS THE DATA BASE OUR OFFICE COORDINATES BY TAKING ALL THE GRANTS THAT COME IN ACROSS THE FEDERAL GOVERNMENT AND HAND CODING THEM ACCORDING TO A PAIN TAXONOMY THAT'S VERY UNIQUE TO PAIN AND WE HOPE IS REALLY HELPFUL TO THE COMMUNITY AND THAT IT'S MUCH MORE TARGETED AND TAILORED FOR OUR NEEDS THAN BROADER REPORTER SYSTEM THAT'S A PUBLICLY FACING TELLING OF WHAT'S IN THE PAIN RESEARCH PORTFOLIO. WE CAN CLEARLY LOOK AT HOW DOLLARS ACROSS NIH ARE SPENT RELATIVE TO PAIN AND THE BREAKDOWN. THERE'S SEVERAL INSTITUTES THAT HAVE A BIGGER PAIN PORTFOLIO BUT THE COMBINATION OF THESE TOGETHER IS WHAT'S REALLY IMPORTANT. AND THEN THE MIDDLE PIECHART IS THE FEDERAL DOLLAR BREAKDOWN, NIH IS CLEARLY THE BIGGEST FUNDER BUT THE OTHER AGENCIES AND DEPARTMENTS REALLY HAVE SOME REALLY UNIQUE NICHES THAT ARE INCREDIBLY IMPORTANT AND IN THEIR CONTRIBUTIONS TO THE PAIN RESEARCH PORTFOLIO, THE FEDERAL PAIN RESEARCH PORTFOLIO. SO ONE THING THAT THE -- TWO THINGS THE STRATEGY DOES IS FULFILLS THE MANDATE OF THE IPRCC, SO IN THE AFFORDABLE CARE ACT THAT CREATED THE COMMITTEE THE MANDATE WAS TO IDENTIFY GAPS IN RESEARCH AND SYMPTOMS AND CAUSES OF PAIN AND MAKE RECOMMENDATIONS TO ENSURE THAT WE DON'T OVERLAP IN OUR EFFORTS ACROSS THE FEDERAL GOVERNMENT IN WHAT WE FUND. IT ALSO COMPLETES THE RESEARCH SECTION OF THE NATIONAL PAIN STRATEGY. SO FOR THOSE OF YOU WHO HAVE BEEN ON THE COMMITTEE FOR A LONG TIME WILL BETTER REMEMBER THAT WHEN THE NATIONAL PAIN STRATEGY WAS PUT TOGETHER THAT WAS A BIG HUGE EFFORT FOR THIS COMMITTEE WHICH WAS REALLY RESEARCH FOCUSED AND THE NATIONAL PAIN STRATEGY WAS MUCH BROADER THAN ONLY RESEARCH. AND SO THE DECISION WAS MADE AT THE TIME TO PUT THE ENERGY AND RESOURCES OF THE COMMITTEE INTO DEVELOPING THE NATIONAL PAIN STRATEGY, THERE WAS A VERY, VERY CLEAR POPULATION RESEARCH STRATEGY PIECE IN THAT BUT THE BIGGER PIECE OF THE RESEARCH STRATEGY WAS HELD OFF UNTIL LATER SO THAT THERE WAS TIME AND ENERGY THAT WE COULD REALLY FOCUS AND DO THE RESEARCH STRATEGY APPROPRIATELY. SO IT FULFILLS THIS COMMITTEE'S MANDATE AND COMPLETES THE NATIONAL PAIN STRATEGY, I THINK TWO IMPORTANT KEY GOALS THAT HAVE BEEN ACCOMPLISHED. SO THE RESEARCH STRATEGY AS YOU'VE BEEN GETTING NOTICES HOPE FROM DISTRIBUTION LISTS IN THE ROLLOUT PROCESS IS OUT, IT'S PUBLIC. THANKS TO ALL YOUR EFFORTS, I THINK IT'S GOING TO BE AN INCREDIBLY USEFUL AND IMPORTANT DOCUMENT. AND SO REALLY OVERALL FROM THE VERY BEGINNING THIS WAS MEANT TO BE A LONG-TERM STRATEGY, WE'RE LOOKING AT SOMETHING LIKE A 10-YEAR TIME FRAME AND HOPEFULLY BETWEEN NOW AND THEN THERE WILL BE AN OPPORTUNITY WHERE THE COMMITTEE CAN LOOK AND EVALUATE HOW WE'RE DOING ALONG THAT TIME SPAN. AND AS YOU KNOW AGAIN, WE HAD A LOT OF PEOPLE FROM THE OUTSIDE VOLUNTEER TIME, SO 70 TO 80 PEOPLE FROM THE SCIENTIFIC COMMUNITY, FROM THE CLINICAL RESEARCH COMMUNITY, FROM THE ADVOCACY COMMUNITY AND FROM THE FEDERAL STAFF THAT PUT AN INCREDIBLE AMOUNT OF TIME INTO TWO YEARS WORTH OF DISCUSSIONS. SO HERE'S OUR STRUCTURE. YOU'VE SEEN THIS MANY TIMES BEFORE. SO I'M NOT GOING TO DWELL HERE. ALLAN, PLEASE JUMP IN AT ANY POINT WHERE YOU WOULD LIKE TO ADD, SUBTRACT ANYTHING FROM WHAT I'M GOING THROUGH HERE IN MY PRESENTATION. SO WE'VE GOT THE CHAIR OF THE IPRCC, THAT'S WALTER. HE'S SITTING OVER THERE. AND US, YOU GUYS ARE ALL SITTING HERE. AND, YOU KNOW, THERE REALLY WAS AN INTENTION THAT THERE WOULD BE OVERSIGHT BUT ALSO FEEDBACK THROUGH THE PROCESS. SO WE WOULD COME BACK TO YOU AT CERTAIN STAGES IN THE DEVELOPMENT, MAKE SURE THINGS WEREN'T MISSED, MAKE SURE WE WERE ON TRACK. THIS COMMITTEE HELPED SET UP THE STEERING COMMITTEE AND THAT STEERING COMMITTEE GAVE THE CHARGE TO SET OF FIVE WORKING GROUPS, AND THE STEERING COMMITTEE ALSO GOT FEEDBACK FROM THE WORKING GROUP, SORT OF DID MILESTONE CHECKPOINTS ALONG THE WAY AGAIN TO MAKE SURE THINGS WEREN'T BEING MISSED. WE WERE ON THE RIGHT TRACK, WEREN'T DUPLICATING THINGS. AND THEN THE WORK GROUPS WHO DID ALL THAT HEAVY LIFTING AS FAR AS PICKING UP THE MANDATE AND GOING THROUGH STEPS I'LL COME TO IN A SECOND AND THEN OUR OFFICE OF PAIN POLICY AT NINDS WILL PUT TIME IN THE BACKGROUND BUT MEANINGFUL MEANINGFUL RESOURCE. THE WAY THE WORK GROUPS WERE SET UP ALIGNED WITH THE NATIONAL PAIN STRATEGY WAS SET UP NOT IN THE SAME WORK GROUPS AS NATIONAL PAIN STRATEGY BECAUSE THERE WAS TOO MUCH OF A STRUGGLE TO FIT THAT INTO A RESEARCH PORTFOLIO IN A MEANINGFUL WAY. WE HAD CHRONIC PAIN WORKING GROUP AND DISPARITIES AS WITH THE NATIONAL PAIN STRATEGY TO MAKE SURE WE COVERED THE ISSUES, THAT IT WAS HIGHLIGHTED AND THAT IT DIDN'T GET LOST OR DILUTED IN THE WORKING GROUP PRIORITIES. I THINK THAT TURNED OUT TO BE A REALLY KEY DECISION FROM THE PLANNING COMMITTEE. QUESTIONS WERE ASKED FROM THE PART OF THE PATIENT'S PERSPECTIVE, WHAT HAPPENS AND WHAT DOES IT HAPPEN TO, WHY? AND HOW CAN WE BEST MANAGE IT? AND IT ALIGNS WITH SORT OF MORE SCIENTIFIC PIECE OF THE BASIC TO CLINICAL SCIENCE REALM, UNDERSTANDING THE MECHANISMING, TRANSLATING THAT INTO BETTER PAIN CARE. LOTS OF THANK YOUS TO BE SAID AT THIS POINT. AGAIN, ALLAN PUT IN AN INCREDIBLE AMOUNT OF TIME AS CO-CHAIR. HERE IS OUR STEERING COMMITTEE WHO WE ENGAGED A NUMBER OF TIME, HAD SOME REALLY HELPFUL INSIGHTS AS TO HOW TO MAKE THE DOCUMENT BETTER. HERE IS THE STAFF AT THE OFFICE OF PAIN POLICY. AND I THINK EVERYBODY'S HERE EXCEPT FOR PREBIE AND LAUREN. >> LINDA, THE SLIDES ARE NOT CHANGING. >> THEY ARE NOT WHAT? >> THEY ARE NOT MOVING. WE CAN'T SEE ANYTHING NEW. >> JUST REFRESH YOUR PAGE, ALLAN, THEY ARE MOVING HERE. SO LEAH IS HERE. KHARA AND KHERYSE AND YOLANDA ARE HERE, THEY PUT IN AN INCREDIBLE AMOUNT OF WORK. YOLANDA AND PREETHI ARE PROGRAM STAFF, NOT IN MY OFFICE, THEY ARE AT NIDCR. I WOULD LIKE TO TAKE THEM. I'M NOT STEPPING ON ANY TOES HERE. A BIG THANK YOU TO THEM. ALLAN, I DIDN'T PUT YOUR PHOTOGRAPH HERE, I DIDN'T PUT MINE AS THE CO-CHAIR BECAUSE I THOUGHT EVERYBODY KNEW WHAT WE LOOKED LIKE AND THE PICTURE THAT ALLAN CHOSE OF ME LOOKED LIKE I WAS STANDING THERE BOSSING PEOPLE AROUND. I DIDN'T WANT TO PUT IT UP. OTHER CO-CHAIRS AGAIN, THIS WAS A BIG BURDEN FOR THE PEOPLE THAT WE ASKED TO SERVE AS CO-CHAIRS OF EACH OF THE COMMITTEES. AND SO WE HAD DAVE RUBIN, BOB GATHEL, ARDEN AND BOB AND TED PRICE FOR TRANSITION, CHARLES STUCKEY AND ROGER, WHO IS HERE, TO DO THE DISPARITIES PIECE. SO A HUGE THANK YOU TO THIS GROUP AS WELL AS TO THE WORK GROUP MEMBERS. SO WE COULD ADVANCE PAIN RESEARCH AND RELIEVE THE BURDEN OF PAIN. THE TASKS THAT THE PLANNING GROUP SET UP WAS TO ISN'T SIZE OVERVIEW SO THERE WAS PORTFOLIO ANALYSIS, PUT TOGETHER TO UNDERSTAND WHAT WAS GOING ON IN THE PORTFOLIO. AND TO IDENTIFY WHAT WAS HOLDING THEM BACK, OPPORTUNITIES THAT WOULD COME IN FROM OTHER FIELDS WHO WERE USING MORE ADVANCED TECHNOLOGY, OR SOME NEW APPROACHES THAT COULD BE APPLIED TO THE PAIN FIELD, AND THEN TO GO ON FROM THERE TO PUT TOGETHER THEIR SET OF RESEARCH RECOMMENDATIONS THROUGH PHONE CALLS OVER THE PAST I'M TOLD TWO YEARS. IT FELT FASTER THAN THAT. ULTIMATE I PRODUCT WAS COMPREHENSIVE SET OF RECOMMENDATIONS. THE FINAL DOCUMENT IS IN YOUR PACKET. THERE IS ONE MINOR CHANGE, THE VETERANS HEALTH ADMINISTRATION, CHRISTINA SENT IN A CHANGE, SORT OF ALERTING US, WE HAD MISSED AN OPPORTUNITY TO CALL OUT THE NEED FOR OUTCOME MEASURES AND PATIENT ASSESSMENTS, WERE NEEDED FOR PEOPLE WHO ARE DIFFICULTY COMMUNICATING. AND SO THOSE WERE HELPFUL CHANGES, I THINK. THIS IS JUST TO REMIND US THAT WE HAD A PLAN EARLY IN THE BEGINNING. WE STUCK PRETTY CLOSELY WITH THAT PLAN. WE ENDED UP A LITTLE BIT PROBABLY BEHIND SCHEDULE. BUT WE'RE STILL, IN MY MIND, IN EARLY 2017 AND WE'RE IN THE ROLLOUT PHASE SO THAT'S THE GOOD NEWS. ONE OF THE THINGS THAT WE HAD DECIDED FROM THE VERY BEGINNING IN THE PLANNING STAGES THAT THERE WOULD BE A WAY TO SORT OF STRATIFY THE PRIORITIES THAT CAME OUT OF THIS PROJECT TO MAKE SURE THAT IF WE HAD AN ENORMOUS LIST, WHICH IS WHAT WE DIDN'T WANT, TO WHITTLE THEM DOWN A LITTLE BIT AND GET A SHORTER SUPER-HIGH PRIORITY SUPER-IMPORTANT SET OF PRIORITIES SO WE HAD A WAY, THIS KIND OF CHANGED A LITTLE BIT, THE PROCESS TO IDENTIFY TOP PRIORITIES. AND WHAT WE ULTIMATELY DID BECAUSE THE WORK GROUPS ACTUALLY CUT THEIR NUMBER OF PRIORITIES DOWN TO WHAT THEY FELT WERE THE MOST IMPORTANT, AND THEN WE ASKED ACROSS THE WORK GROUPS TO VOTE ON ALL THE PRIORITIES AND RANK THEM AND THE TOP QUARTILE OF THOSE WERE SELECTED AND NOTED HOPEFULLY VERY CLEARLY IN THE REPORT AN APPENDIX AT THE BACK OF THE REPORT AS BEING THE TOP PRIORITIES CONSIDERED BY ALL THE WORKING GROUPS. THESE ARE THE LISTING OF TOP PRIORITIES, PRETTY CLEARLY MARKED IN THE DOCUMENT THAT YOU HAVE. AND SOME OF THEM, THEY ARE COLOR-CODED HERE, I'LL TELL YOU WHY IN A MOMENT. AS WE WENT THROUGH -- LET ME BACK UP FOR A SECOND. YOU WILL SEE SOME OF THESE TOP PRIORITIES SHOWED UP IN TRISH'S PRESENTATION ON THE COMMON FUND. THERE'S A REALLY GOOD ALIGNMENT WITH WHAT THE TASK FORCE WITH RESEARCH STRATEGY FELT WAS IMPORTANT THAT HELPED US AS SORT OF -- YOU KNOW, WE HAVE OUTSIDE STAKEHOLDER INPUT THAT THINKS THIS COMMON FUND INITIATIVE IS MORE THAN. I'LL COME BACK TO THE CONCEPT OF HOW THAT IS USED BY THE AGENCIES. THIS KIND OF DOCUMENT IS USED BY THE AGENCIES TO HELP PUT FORWARD BIG INITIATIVES LIKE THE COMMON FUND AND SMALLER INITIATIVES THAT MIGHT BE INSTITUTE-SPECIFIC, FOR EXAMPLE. SO WE HAD TWO OTHER MEASURES THAT WE WANTED TO MAKE NOTABLE AND THIS WAS A SUGGESTION OF THE STEERING COMMITTEE. SO THEY ASKED US TO HAVE THE GROUPS IDENTIFY AND WE DID THIS WITHIN WORK GROUPS, WHICH OF THE PRIORITIES IN THEIR SET, THEIR INDIVIDUAL WORK GROUP SET, WAS THE MOST IMPACTFUL, WOULD BE THE MOST IMPACTFUL IF MOVED FORWARD. SCIENCE MIGHT NOT BE READY OR READY TO MOVE IT FORWARD RIGHT AWAY BUT WE WANTED THEM TO IDENTIFY IF YOU'VE GOT SEVEN PRIORITIES IN YOUR LIST WHICH ONE WILL BE THE MOST IMPACTFUL TO THE RESEARCH COMMUNITY AND TO PAIN MANAGEMENT. THE OTHER ONE WE ASKED FOR WAS œVALUE.AS THE GREATEST NEAR-TERM IN OTHER WORDS, WHAT CAN BE MOVED FORWARD IMMEDIATELY AS AN IMPORTANT PRIORITY. AND SO THESE, THE YELLOWY ONES AT THE TOP, ARE THE ONES ACROSS THE GROUPS -- THEY ARE ALL TOP PRIORITIES BUT THESE WERE ALSO LISTED IN -- FOR EXAMPLE THE MOST IMPACTFUL WHERE THE COLOR MEANS THEY GOT VOTED ONE OR TWO OR THREE OF THESE THINGS, TOP PRIORITY PLUS MOST IMPACTFUL OR PLUS GREATEST NEAR-TERM VALUE. SO TO ME IN MY MIND THAT ELEVATES THE ONES THAT HAVE THE MULTIPLE COLORS ON HERE AND IT WILL HELP THE FUNDING AGENCIES AS THEY LOOK THROUGH THE DOCUMENT AND SEE WHAT THEY WANT TO TARGET IN THEIR FUNDING PRIORITIES. THESE WERE FELT TO BE THE MOST IMPACTFUL FROM THEIR GROUP, AGAIN MARKED IN YOUR DOCUMENT. THESE ARE THE ONES THAT EACH OF THE GROUPS INDIVIDUALLY FELT HAD THE GREATEST NEAR-TERM VALUE FROM ALL THE PRIORITIES THAT THEY PUT TOGETHER. AND SO WHAT WE HAVE AS A FINAL DOCUMENT IS A COMPREHENSIVE LIST, IT COVERS THE MISSIONS OF ALL THE AGENCIES IN THE DEPARTMENTS THAT WERE INVOLVED IN PULLING THE STRATEGY TOGETHER. IT COVERS -- EACH OF THE WORK GROUPS MADE A BIG EFFORT TO LOOK AT THE STATE OF THE SCIENCE SO THEY SPENT A LOT OF TIME LOOKING THROUGH THE PORTFOLIO, WHAT CURRENT RESEARCH IS BEING DONE. THEY REACHED OUT TO LITERATURE, THEY DID LITERATURE SURVEYS AND REACHED OUT TO EXPERTS IN A SURVEY PROCESS TO FOLKS WHO WERE NOT SERVING ON THE PARTICULAR WORK GROUP SO THEY REALLY LOOKED FOR INPUT FROM A BROADER GROUP THAN WE INITIALLY PUT TOGETHER FOR THE TASK FORCE. AND WE HAD PATIENT ADVOCATES THAT SERVED IN THE WORK GROUPS TO ENSURE THE NEEDS OF PEOPLE WITH PAIN WERE REPRESENTED IN THE STRATEGY, COVERED THE CONTINUUM AND ENDED UP WITH A DOCUMENT THAT HAD TOP PRIORITIES, MOST IMPACTFUL, GREATEST NEAR TERM AND ANOTHER SET OF WHAT WE CONSIDERED REALLY IMPORTANT PRIORITIES. SO AS FAR AS NEXT STEPS, THIS WILL SERVE AS A GUIDANCE DOCUMENT FOR AGENCIES AND DEPARTMENTS THAT SUPPORT PAIN RESEARCH. IT'S NOT A MANDATE TO FUND THIS SET OF PRIORITIES. WE DON'T REALLY HAVE THE AUTHORITY TO DO THAT AND WE KNEW FROM THE BEGINNING WE DIDN'T. AS I SAID, THE AGENCIES AND DEPARTMENTS WERE INVOLVED. WE WANTED TO MAKE REALLY SURE THAT WE COVERED THE SPECTRUM OF RESEARCH THAT WAS OF INTEREST AND WITHIN THEIR MISSION RELEVANCE. THESE WERE -- IT WILL BE A WAY TO HELP THE DEPARTMENTS AND AGENCIES COLLABORATE IN THEIR RESEARCH PROGRAMS AND I THINK THERE'S BEEN A LOT OF THAT TALK THROUGHOUT THE PROCESS. AND THEN WE HAVE FOR THE FUNDING AGENCIES THE SPECIFIC NOTATIONS ATTACHED. AND REALLY QUICK EXAMPLES OF HOW I THINK THE FEDERAL PAIN RESEARCH STRATEGY HAS ALREADY BEGUN TO BE HELPFUL IN OUR PLANNING STAGES FOR INITIATIVES, SO TRISH ACTUALLY HAD THESE FEDERAL PAIN RESEARCH PRIORITIES LISTED IN HER SLIDES. I ADDED ONE AT THE BOTTOM THAT IS RELEVANT TO DATA THAT MIGHT COME OUT OF THE CONCEPT THAT SHE PRESENTED IN THAT WE WILL COLLECT INFORMATION ON HOW PAIN MANAGEMENT IS DONE WITHIN THE COMMON FUND CONCEPT AND SO THIS WOULD BE THE BOTTOM ONE HERE, TRIALS TO DETERMINE ACUTE PAIN MANAGEMENT STRATEGIES, FOR PAIN PREVENTION, CHRONIC PAIN PREVENTION, MIGHT BE A FIRST STEP TOWARDS MOVING TOWARDS THAT PRIORITY. SO WHEN AN AGENCY PULLS TOGETHER AN INITIATIVE LIKE THE COMMON FUND OR WHEN AN INSTITUTE PROPOSES AN INITIATIVE TO THEIR ADVISORY COMMITTEE TO MOVE FORWARD ONE OF THE JUSTIFICATIONS IS WE HAVE REACHED OUT TO THE OUTSIDE STAKEHOLDER COMMUNITY TO MAKE SURE THAT WE ARE ON THE RIGHT TRACK, THAT WE'RE NOT DUPLICATING THINGS, THIS IS AN IMPORTANT GAP AREA. AND SO THE RESEARCH STRATEGY IS REALLY THINK A STRONG PIECE TO SHOW THAT THERE IS JUSTIFICATION FOR THE PARTICULAR KIND OF RESEARCH THAT'S BEING PUT INTO A PROPOSED FUNDING OPPORTUNITY ANNOUNCEMENT. AND I DON'T THINK YOU CAN GET A FUNDING OPPORTUNITY ANNOUNCEMENT CONCEPT THROUGH AN INSTITUTE OR THROUGH THE COMMON FUND WITHOUT THAT KIND OF STAKEHOLDER INPUT. THIS WAS IMPORTANT I THINK IN DEVELOPING THE COMMON FUND PROPOSAL. AND THE OTHER ACTIVITIES GOING ON AT NIH OVER THE PAST SUMMER FOR THE DEVELOPMENT OF PUBLIC/PRIVATE PARTNERSHIP FOR OPIOID OVERDOSE -- OPIOID USE DISORDERS AND BETTER PAIN MANAGEMENT DEVELOPMENT WE HAD THREE CROSS-CUTTING MEETINGS, LOTS MORE INFORMATION COMING THIS AFTERNOON ON THOSE, BUT AT EACH WIN OF THOSE MEETINGS WE PULLED FROM THE FEDERAL PAIN RESEARCH STRATEGY THE RECOMMENDATIONS THAT WERE MADE IN THAT DOCUMENT THAT ALIGNED WITH SOME OF THE ACTION ITEMS THAT CAME OUT OF THOSE MEETINGS. SO AS THOSE ACTION ITEMS MOVED FORWARD, I THINK THAT AGAIN THE RESEARCH STRATEGY WILL BE HELPFUL IN PROMOTING RESEARCH INITIATIVES RELATED TO THOSE. AND HERE THESE ARE SOME OF THE EXAMPLES THAT WE GAVE DURING THE MEETINGS AND DURING THE FOLLOW-UP MEETING AT THE NATIONAL ACADEMY OF MEDICINE, AND SO YOU CAN SEE THE ORANGE IS THE TOPIC FROM THE MEETINGS, AND THEN THE BLACK TYPE-SET ARE TITLES OF THE FEDERAL PAIN RESEARCH PRIORITIES. SO THE POINT IS HERE THAT THE RESEARCH STRATEGY IS AND WILL BE HELPFUL IN MOVING THESE KIND OF RESEARCH OBJECTIVES FORWARD. THAT WAS THE FIRST MEETING. THIS IS THE SECOND MEETING. AND ANOTHER SET OF RESEARCH PRIORITIES STRAIGHT OUT OF THE FEDERAL PAIN RESEARCH STRATEGY THAT ALIGNED WITH THE DISCUSSIONS AND ACTION ITEMS THAT CAME OUT OF THOSE MEETINGS. AND SO RIGHT NOW WE'RE IN THE MIDDLE OF THE ROLLOUT. WE WANTED TO COORDINATE THAT ROLLOUT WHICH IS A DISSEMINATION OF INFORMATION TO AS MANY PEOPLE AS WE CAN GET TO THAT THE STRATEGY IS OUT, AND WE ARE DOING -- WE'RE USING OUR DISTRIBUTION LISTS, OUR WEBSITES, WE HOPE YOU WILL HELP PASS THE MESSAGE ALONG TO YOUR ORGANIZATIONS. AND WHERE IT'S GOING FROM HERE AT LEAST TWO OF OUR WORKING GROUPS ARE WORKING ON A PUBLICATION THAT WILL PUT TOGETHER SOME OF THE DETAILS OF THE CONVERSATIONS THAT THEY HAD OVER THE COURSE OF THE TWO YEARS RELATED TO THEIR WORK GROUP TOPIC THAT DON'T ACTUALLY SHOW UP. A LOT OF BACKGROUND INFORMATION AND WONDERFUL DISCUSSIONS THAT AREN'T REFLECTED COMPLETELY IN THE RESEARCH STRATEGY. SO IT'S HELPING TO SUPPORT THE PUBLIC/PRIVATE PARTNERSHIP, THE COMMON FUND AND HOPEFULLY SOON SOME OTHER FUNDING OPPORTUNITIES THAT MIGHT COME OUT ACROSS THE AGENCIES AND DEPARTMENTS. AND MAY SERVE FOR FUTURE BENCHMARKS HOW WE'RE DOING WITH PAIN RESEARCH OVER THE NEXT TEN YEARS. SO I'LL STOP THERE AND TAKE QUESTIONS. >> IF I COULD JUST ADD A COUPLE THINGS, LINDA. >> GO AHEAD, ALLAN, PLEASE. >> ONE THING, SOME OF THE THINGS THAT YOU JUST SAW SEEM SO OBVIOUS, AND I REALLY URGE EVERYBODY TO ACTUALLY READ THE BACKGROUND DOCUMENT BECAUSE SOME OF THEM MAY EVEN SOUND OVERLAPPING OR OF COURSE WE'RE LOOKING FOR BETTER PAIN MANAGEMENT APPROACHES, BETTER NON-OPIOID APPROACHES, BUT THE DETAILS ARE REALLY IN THE DOCUMENT AND IT'S ABSOLUTELY CRITICAL. I THINK ONE OF THE MOST INTERESTING THINGS THAT DID COME OUT IN THE SLIDES THAT LINDA SHOWED AND IT WAS AN INTERESTING DISCUSSION THAT WENT ON FOR THE WHOLE YEAR IS THIS NOTION OF RESILIENCE. ONE OF THE THINGS WE'RE ALWAYS INTERESTED IN IS WHAT IS IT THAT MAKES AN INDIVIDUAL SUSCEPTIBLE TO DEVELOPING CHRONIC PAIN FROM AN ACUTE PAIN CONDITION OR EVEN THE POSSIBILITY THERE IS NO TRANSITION, THAT A PERSON REALLY IS IN A STATE OF CHRONIC PAIN FROM THE MOMENT THE INJURY OCCURS. ON THE OTHER SIDE WHAT IS IT ABOUT INDIVIDUALS THAT DO NOT TRANSITION, THE NOTION THERE ARE RESILIENCE FACTORS OR EVEN FACTORS THAT WILL ALLOW YOU TO RECOVER MORE QUICKLY IS REALLY RELATIVELY NEW ONE THAT'S NOT BEEN STUDIED. THE ONLY LAST POINT THERE WAS AN INTERESTING DISCUSSION, SHOULD WE ONLY FOCUS ON THINGS THAT AREN'T BEING DONE ALREADY, THAT AREN'T BEING FUNDED, AND THE ANSWER WAS NO BECAUSE WE DIDN'T WANT TO LEAVE THE MESSAGE THAT SOME OF THE ONGOING RESEARCH IS REALLY NOT HIGH PRIORITY. IT OBVIOUSLY IS. AND SO THE DOCUMENT INCLUDES BOTH STUDIES OR SUGGESTION OF STUDIES ONGOING, AS WELL AS NEW DIRECTIONS, HOPEFULLY AREAS TRANSFORMATIVE FOR BETTER UNDERSTANDING OF PAIN MECHANISMS AND OBVIOUSLY FOR MANAGEMENT. >> THANKS, ALLAN. QUESTIONS? >> LINDA, I'D JUST LIKE TO COMPLIMENT YOU AND ALLAN AND THE TEAM FOR THIS INITIATIVE. IT'S BEEN REALLY DIFFICULT THING TO PULL TOGETHER. YOU SHOULD BE APPLAUDED FOR WHAT YOU'VE DONE. I WOULD LIKE TO GO BACK TO AS YOU BEGIN TO IMPLEMENT THIS WHICH IS GOING TO TAKE TIME, YOU NOTED IN ONE OF YOUR FIRST SLIDES THE PIECHART OF FUNDING, AND A COUPLE OF THE INITIATIVES PUT FORWARD THAT ARE ALREADY IMPLEMENTED. AS I UNDERSTAND IT, THE CENTER FOR SCIENTIFIC REVIEW IS NOW DEVELOPING A PAIN FOCUS STUDY SECTION. >> YES. >> IT'S A VERY BIG STEP IN THE RIGHT DIRECTION. AND THE SECOND ITEM THAT I REMEMBER FROM A FEW MEETINGS AGO IS THAT THE CENTER FOR SCIENTIFIC REVIEW HAD AGREED TO USE AN AMERICAN PAIN SOCIETY LIST OF REVIEWERS THAT COULD SERVE AS AD HOC REVIEWERS TO STUDY SECTIONS WHERE THERE AREN'T -- WHERE THERE'S NOT PAIN EXPERTISE. AND I'M CURIOUS WHETHER THAT PROCESS IS STILL OCCURRING. IT'S MY IMPRESSION, ONLY AN IMPRESSION, THAT PROCESS MAY NOT BE FULLY IMPLEMENTED. BUT I THINK THOSE TWO THINGS TOGETHER, A PAIN FOCUS STUDY SECTION AND THEN CRS AS DR. NAKAMURA NOTED THEY WOULD BE USING THIS APS LIST OF REVIEWERS TO HELP SIGN AD HOC RUE VIEWERS TO NON-ORIENTED SECTION, IF THAT'S STILL THE CASE. >> WE HAVE SOMEBODY THAT CAN HELP US WITH THAT TODAY. THEY HAVE USED THE LIST IN THE PAST THOUGH, SO APS WAS SENDING A LIST OF FOLKS THEY HAD SORT OF NOT -- I DON'T WANT TO SAY PRE-CLEARED, BUT THEY POSTED WHAT THE ELIGIBILITY WAS SO PEOPLE WERE AWARE AND COULD SIGN UP AS VOLUNTEERS. CATHY MAY ACTUALLY KNOW WHERE THAT STANDS. WE TALKED ABOUT IT AT OUR -- THE ANNUAL APS BOARD MEETING, NIH MEETING, SO I'LL TURN IT OVER TO HER. >> I KNOW THAT THE LIST HAS BEEN USED, AND AS I UNDERSTOOD FROM ROB JARREAU, THEY WERE CONTINUING TO UPDATE, SO I DON'T THINK THAT'S AN ISSUE. THE PAIN RESEARCH STUDY SECTION WAS ALSO ON OUR AGENDA THAT DAY, AND I BELIEVE THAT'S SLATED FOR JANUARY. STRTED ALREADY. SO ALL OF THE THINGS WE'VE BEEN WORKING FOR ARE HAPPENING. WHICH IS VERY EXCITING. >> ANY OTHER QUESTIONS? OKAY. THANK YOU VERY MUCH. THANK YOU TO THE COMMITTEE FOR YOUR EFFORTS ON THE RESEARCH STRATEGY. THIS WAS A BIG EFFORT ON THE PART OF THE COMMITTEE AND WE'RE DONE. WE'RE DONE STAGE ONE. WE'RE MOVING INTO IMPLEMENTATION NOW. I SAW DR. SINGH MOVE IN. I WANT TO ASK YOU IF WE ARE A LITTLE BIT LATE ON OUR BREAK IF THAT STILL FITS WITH YOUR SCHEDULE FOR TODAY? FIVE OR TEN MINUTES. OKAY. WE'RE SCHEDULED NOW FOR A BREAK. AND IF WE COULD GET BACK HERE BY QUARTER TO ELEVEN ON THE BUTTON WE WILL START THEN. WE GOT THE RIGHT HOUR, YEAH. IT'S A PLEASURE TO INTRODUCE DR. VANILA SINGH, OFFICE OF ASSISTANT SECRETARY, SHE WAS NAMED CHIEF MEDICAL OFFICER THIS SUMMER, JUST BEFORE TOM NOVOTNY RETIRED FROM THAT POSITION. PRIMARY MEDICAL ADVISER TO ASSISTANT SECRETARY ON DEVELOPMENT AND IMPLEMENTATION OF HHS-WIDE PUBLIC HEALTH POLICY RECOMMENDATIONS, FOR THE PAST 13 YEARS DR. SINGH HAS BEEN A CLINICAL ASSOCIATE PROFESSOR OF ANESTHESIOLOGY AT STANFORD, SHE'S A BOARD CERTIFIED PRACTITIONER OF ANESTHESIOLOGY AND PAIN MEDICINE, AND SPECIALIZES IN CHRONIC PAIN MANAGEMENT. SHE GRADUATED FROM UNIVERSITY CALIFORNIA BERKELEY, MEDICAL DEGREE FROM GEORGE WASHINGTON UNIVERSITY, COMPLETED INTERNAL MEDICINE INTERNSHIP AT YALE, ANESTHESIA AT CORNELL, IT'S A PLEASURE TO HAVE HER TALK TO US ABOUT A NEW CARA TASK FORCE. VANILA? >> THANK YOU. HI, GOOD MORNING, EVERYBODY. IS THAT TOO LOUD OR IS THAT OKAY? PERFECT. I DON'T HAVE SLIDES. I HOPE THAT'S OKAY. I THINK THAT WHEN I WAS LOOKING AT A COUPLE YEARS AGO HOW MANY POWER POINTS WE ALL DO, I'VE DONE A GAZILLION, AS YOU HAVE, IT'S EXCITING TO DO A MEET AND GREET HOPEFULLY FOR MANY FUTURE VISITS. I COME BY WAY AS I WAS JUST INTRODUCED, AND THANK YOU FOR THE INTRODUCTION, IT'S AN HONOR TO BE HERE. I HAVE BEEN PRACTICING CLINICAL PAIN MEDICINE AT STANFORD FOR THE PAST 13 YEARS WITH SOME OF YOUR COLLEAGUES OUT THERE. AND MY FORTE IS IN ULTRASOUND, GUIDED BLOCKS IN THE PAIN REALM AS WELL AS REGIONAL ANESTHESIA. KIND OF THE WHOLE PERIOPERATIVE PERSISTENT PAIN TO CHRONIC PAIN. AND IT HAS BEEN THE GREATEST HONOR OF MY LIFE TO TAKE CARE OF SOME OF THE MOST, AS WE KNOW, CHALLENGED PATIENTS WHO REALLY GO THROUGH SO MUCH. AND MY BACKGROUND REALLY AT BERKELEY WAS IN MOLECULAR AND CELL BIOLOGY, SO I LOVE THAT. SO JUST HEARING FOLKS TALK ABOUT THAT AND KNOWING THAT THE INTERAGENCY PAIN RESEARCH COMMITTEE IS SPEAKING IN THE REALM OF PAIN AND THAT WE HAVE AN OPPORTUNITY RIGHT NOW AT THIS TIME IN OUR NATION TO REALLY DO THE THINGS THAT MANY OF US HAVE BEEN HOPING FOR FOR DECADES, I THINK WILL BE VERY EXCITING, AND I DO HAVE GREAT FAITH THAT WE WILL RISE TO THE OCCASION. THE OTHER THING IS I GOT INVOLVED WITH POLICY REALLY A FEW YEARS AGO, WHEN I WAS VERY CONCERNED ABOUT MUCH OF WHAT WAS GOING ON, IT WASN'T SO MUCH ABOUT POLITICS BUT RATHER THAT WE REALLY NEEDED THE FOLKS TRULY INVOLVED IN PATIENT CARE TO HELP SHAPE POLICY BOTH IN THE CLINICAL REALM, EDUCATION AND RESEARCH. AND SO MY HOPE IS WE'LL BE ABLE TO ACHIEVE SOME OF THAT. I'M HERE TODAY AT LINDA'S INVITATION. I SUPER APPRECIATE IT. HAVE HAD A WONDERFUL TIME GETTING TO KNOW HER. AND CHAD HELMICK OVER THE E-MAILS, WE FINALLY GET TO IMMEDIATE TODAY AND MANY FOLKS WHO I HAD AN OPPORTUNITY TO MEET AT THE PAIN ROUNDTABLE. WE'RE GOING TO TALK ABOUT THE CARA ACT, COMPREHENSIVE ADDICTION AND RECOVERY ACT OF JULY 2016, PASSED UNDER PRESIDENT OBAMA AND THE REPUBLICAN CONGRESS, SO BIPARTISAN AND VERY NEEDED. THE SUBSECTION ON THAT ACT IS THE SUBSECTION 101 WHICH IS ABOUT ACUTE AND CHRONIC PAIN SO THE CARE ACT HAS BEEN HIGHLIGHTED OF LATE, GIVEN THE OPIATE CRISIS SORT OF CONTEXT, MUCH OF THIS ACT WAS PASSED, AND I THINK THE SILVER LINING IN ALL OF THIS IS THAT IT ASKED FOR A CONGRESSIONALLY MANDATED PAIN TASK FORCE. AND THE PRIMARY OBJECTIVE OF THIS TASK FORCE IS THREE-FOLD. IT IS, ONE, TO GIVE BEST PRACTICE GUIDELINES AS AN ADVISORY COMMITTEE TO THE FEDERAL AGENCIES ABOUT WHAT'S THE BEST WAY TO PRESCRIBE PAIN MEDICINE BUT ALSO MANAGEMENT OF ACUTE AND CHRONIC PAIN. NUMBER TWO IS TO IDENTIFY GAPS AND INCONSISTENCIES THAT MAY EXIST IN THE CURRENT SYSTEM THAT WE HAVE AS OF NOW. AND THEN NUMBER THREE, HOW TO BEST DISSEMINATE THAT INFORMATION. AND THAT LAST PART I THINK IS SO IMPORTANT BECAUSE THOSE OF US WHO HAVE BEEN OUT AND PRACTICING IN THE ACADEMIC ARENA AND HAVE CARED ABOUT THIS ISSUE FROM DIFFERENT LENS, MUCH OF SOMETIMES WHAT'S GOING ON HERE IN WASHINGTON ISN'T NECESSARILY FILTERING TO OUR PARTNERS AND COLLEAGUES OUT ON THE FRONT LINES. AND SO I THINK THAT WILL BE OF GREAT IMPORTANCE. AND SO THE PAIN TASK FORCE BASICALLY I WAS GIVEN THE LEAD FOR THIS. IT SAT FOR ALMOST A YEAR. AND IT SUNSETS IN JULY OF 2019. SO THERE'S A VERY IMPORTANT AND TANGIBLE TIME LINE FOR THIS. SO WITHIN A MONTH OF MY GETTING HERE, THE FIRST THING I HAD TO DO WAS REALLY HOW DO YOU GET THIS UP AND RUNNING? AND SO WE DID ALL THAT. WE GOT THE CHARTER SET, AND ALL THE OTHER PAPERWORK, AND THE APPLICATION SYSTEM WAS OPENED IN AUGUST. AND JUST CLOSED IN SEPTEMBER 27th. I CAN TELL YOU HERE TODAY THAT WE'VE HAD AN INCREDIBLE AMOUNT OF INTEREST FROM EXPERTS ALL AROUND THE COUNTRY. AND THE REQUIREMENTS BY STATUTE ARE VERY SPECIFIC. THEY ARE NOT JUST THE PRESCRIBING PHYSICIANS, SO M.D.s, DOs, BUT ALSO PHARMACIST, DENTISTS, PHARMACY ORGANIZATIONS, MEDICAL ORGANIZATIONS, ALSO PATIENT ADVOCACY GROUPS, REALLY IMPORTANT IN MY VIEW, BECAUSE FOLKS WHO HAVE ACTUALLY -- WHO ACTUALLY CONTINUE TO EXPERIENCE THIS ARE VETERANS, VETERAN ORGANIZATIONS, ALSO FIRST RESPONDERS WHO ARE ON THE FOREFRONT. IN ADDITION TO THAT, LEADERS AND EXPERTS IN THE MENTAL HEALTH TREATMENT COMMUNITY, THE ADDICTION TREATMENT COMMUNITY, AND ALSO REPRESENTATIVES FROM THE STATE MEDICAL BOARDS, AS WELL AS HOSPITAL ASSOCIATIONS. NOW, IT'S A VAST REQUIREMENT AND OF COURSE ONLY CONGRESS COULD COME UP WITH THIS WHERE THEY THREW EVERYTHING IN THE POT, AND SAID COME UP WITH A TASK FORCE. SO THE WAY IT'S GOING TO WORK IS IT'S GOING TO BE NOT TO EXCEED 30-MEMBER GROUP OF FOLKS, OF WHICH 2/3 BY MY ESTIMATE WILL BE NON-FEDERAL PARTNERS, EXPERTS AND STAKEHOLDERS, AND THEN OUR FEDERAL PARTNERS WILL BE FOLKS FROM HHS, CERTAINLY NIH, WHICH WERE GREAT FOR CONTRIBUTING MONEY, NOW I REALIZE, WOW, THAT'S SO IMPORTANT. AND CDC AS WELL AS SAMHSA AND THEN PERHAPS WE'LL ALSO GET THE INDIAN HEALTH SERVICES. IT IS AN INTERAGENCY TASK FORCE SO THE REQUIREMENT IS THAT THE SECRETARY OF HHS CONVENE THE MEETING WITH THE SECRETARY OF THE DEPARTMENT OF DEFENSE AND SECRETARY OF THE VETERANS ADMINISTRATION. SO THAT WILL HAPPEN, AND THAT OF COURSE THEY WILL HAVE REPRESENTATIVES FROM DoD AND V.A. AND ALSO THE DRUGS ONDCP WILL BE REPRESENTED SO AS YOU CAN SEE THIS IS A COMPREHENSIVE TASK FORCE THAT IS MANDATED. AND IT WILL HAVE NO LESS THAN TWO MEETINGS. I ANTICIPATE OUR FIRST MEETING WILL BE EARLY NEXT YEAR, 2018. SO JANUARY, FEBRUARY. WE'RE WORKING ON THAT. WE WERE TRYING TO GET AN AD HOC MEETING TO GET OUR MEMBERSHIP ON BUT SOUNDS LIKE MOVING MOUNTAINS IN THE GOVERNMENT SO THEY FINALLY SAID STOP, TO ME, AND SO WE'RE PROBABLY NOT GOING TO DO THAT. WE'LL GET IT UP AND RUNNING, THE CONVENTIONAL MEETING, IN JANUARY OR FEBRUARY AND THEN A SECOND MEETING TO FOLLOW SUIT. THERE WILL BE SUBGROUPS, WORKING GROUPS, EVEN FOLKS NOT ON THE TASK FORCE MY HOPE IS WE CAN BRING SOME EXPERTS IN TO THOSE SUBGROUPS WHERE THE REAL WORK WILL HAPPEN TO EXPRESS OPINIONS, SO EVEN IF, YOU KNOW, YOU APPLIED AND HAD INTEREST, I'M VERY MUCH SUPPORTIVE THAT THE VOICES ARE THERE. AND SO, YOU KNOW, CERTAINLY OUR COLLEAGUES IN CMS AND OTHER FOLKS WHO REALLY HAVE TO HEAR IT IN ORDER FOR, YOU KNOW, GOOD POLICY WITHOUT COVERAGE, YOU KNOW, IS JUST GOOD THEORY. AND SO WE REALLY WANT THE RIGHT PEOPLE THERE AND I KNOW MANY OF YOU HAVE GREAT INTEREST AND A LOT TO SAY IN THIS SO WE'LL TRY TO INCORPORATE SOME OF THAT. WE'RE NOW IN THE PROCESS WHERE WE'RE GOING TO SET UP OUR APPLICATION REVIEW PROCESS AND HOPEFULLY ANNOUNCE OUR MEMBERS AS WELL AS ALTERNATE MEMBERS GOING FORWARD. AND THAT'S KIND OF THE LARGE OVERVIEW OF THIS. WE HAVE THE BEST TEAM IN TERMS MUCH GETTING FEDERAL CONTRACTORS ON BOARD TO REALLY HELP US DO THIS RIGHT, WHICH I KNOW EVERY ONE OF YOU HERE ARE VESTED IN THAT. I MEAN, IT IS MUSIC TO MY EARS TO COME INTO A CONFERENCE AND HEAR THE TALKS GOING ON BECAUSE THIS IS SO LONG OVERDUE. AND IF I CAN SAY JUST ONE PERSONAL THING, WHEN I WAS DOING MY FELLOWSHIP IN PAIN AT CORNELL, WHICH IS THE MULTI-DISCIPLINARY WITH COLUMBIA AND SLOAN-KETTERING AND HHS, I WAS IN THE BASEMENT WHERE OUR CLINIC WAS, THE BASEMENT WHERE THE TUNNEL SYSTEM IS. IT'S SCARY DOWN THERE. I REMEMBER LIKE, YOU KNOW, THIS IS 15 YEARS AGO, THINKING, YOU KNOW, I DON'T KNOW, AM I THE ONLY ONE WHO SEES THIS? THIS IS AN IMPORTANT FIELD. THAT WAS HOW WE WERE VIEWED. AND RIGHT NOW WE ARE VIEWED I CAN TELL YOU CERTAINLY IN SO MANY REALMS WITH SUCH GREAT INTEREST. I WAS OVER AT THE AMERICAN SOCIETY OF ANESTHESIA THIS LAST WEEKEND. YOU KNOW, THE ANNUAL MEETING IS GOING ON. MANY OF MY BROTHERS AND SISTERS, AND I WENT TO SPEAK ON THE ADMINISTRATION'S RESPONSE TO THE OPIOID CRISIS AND FOCUSED AND BROUGHT FOCUS OF COURSE WHICH WENT INTO PAIN, AND, YOU KNOW, WHAT WE HOPE TO DO. I GAVE ACCOLADES OF COURSE TO NIH, NOT ONLY WITH THE WORK THAT'S BEING DONE BUT THE NEW INTERAGENCY FORCE FOR THE VETERANS AND MILITARY AND $81 MILLION GOING TO THAT, TO THIS COMMITTEE, WHICH HAS, YOU KNOW, BEEN STANDING STRONG WITH FOLKS WHO HAVE BEEN DEDICATED TO THIS, AND I WAS VERY PROUD TO TELL THEM THAT THERE ARE A LOT OF PEOPLE WHO ARE HERE, HAVE THE EXPERTISE AND ARE ALREADY, YOU KNOW, GETTING THE SOLUTIONS ON THE TABLE AND CERTAINLY OUR FDA COLLEAGUES I KNOW SHARON HERTZ IS GOING TO SPEAK LATER ABOUT THE REMs MODIFICATIONS BUT WE HAVE TO BALANCE, AS SOMEBODY WHO SPENT MY WHOLE CAREER TAKING CARE OF PAIN PATIENTS, WE'LL HAVE TO BALANCE THE EFFECTS OF THE MISUSE AND OVERDOSE DEATHS WITH THE APPROPRIATE INDICATIONS FOR OUR PATIENTS WHO WE KNOW ARE ALREADY SUFFERING FROM GREAT STIGMA THAT HAS OWN BEEN HEIGHTENED AND I THINK IT'S GOING TO BE UP TO ALL OF US TO NOT ONLY HELP THEM BUT HOPEFULLY RAPIDLY ADVANCE NOVEL STRATEGIES WITH NEWER PARTNERSHIPS SO THAT WE COME OUT WITH THE THINGS THAT WE'VE ALWAYS WANTED TO DO, WE CAN FINALLY DO THEM. BUT I'M OPEN TO ANSWERING ANY QUESTIONS ABOUT THE PAIN TASK FORCE, OR OVER IN THE OFFICE OF THE ASSISTANT SECRETARY OF HEALTH, ANY OF OUR ONGOING ACTIVITIES. >> WHEN YOU DO YOU THINK THE LIST OF COMMITTEE MEMBERS WILL BE RELEASED? >> SO THAT'S A GREAT QUESTION. AT THIS POINT, I WOULD GUESS IN NOVEMBER, SOMETIME MID-NOVEMBER. YES? >> I WANT TO THANK YOU FOR ALL THE WORK AND OBVIOUS ENERGY THAT YOU'RE BRINGING TO THIS. I DO WANT TO GO ON THE RECORD POINTING OUT AN AREA OF CARA THAT IS OF GREAT CONCERN AS A CLINICIAN. >> PLEASE DO. >> YEAH, THAT IS SECTION 704 UNDER MEDICARE C AND D DOES EXEMPT HOSPICE BUT I'M SUMMARIZING THEY IDENTIFY INDIVIDUALS WHO ARE AT RISK, BENEFICIARIES WHO ARE AT RISK. YET THAT'S NOT REALLY CLEARLY DEFINED. AND FOR THOSE PEOPLE WHO ARE AT RISK AND I HAVE A SENSE IT WOULD PROBABLY BE HOW MUCH OPIOID THEY ARE PRESCRIBED, THEY WILL BE RELEGATED TO HAVE ONE PRESCRIBER AND ONE PHARMACY THAT THEY CAN GO TO. I KNOW THE DEVIL IS IN THE DETAILS. I'M HOPING AS THE CARA ACT MOVES FORWARD PEOPLE CAN WORK THROUGH SOME OF THAT. I CARE FOR PEOPLE WITH CANCER, PEOPLE WITH HEMOPHILIA, BECAUSE WE'RE HEMATOLOGY/ONCOLOGY DIVISION. THAT WOULD BE DEVASTATING. ALL THE PEOPLE THAT I WOULD BE CARING FOR TODAY WOULD HAVE TO GET A PRESCRIPTION FROM SOMEONE ELSE, AND IT WOULD NOT BE VALID. I WANT TO PUT THAT ON THE TABLE. I WANTED EVERYBODY TO BE AWARE THIS IS A CONCERN. THERE'S SO MANY WONDERFUL THINGS IN THE ACT, I DON'T WANT TO DIMINISH THE ENTIRE ACT, BUT THAT'S A PIECE THAT HAS SOME OF US GREATLY CONCERNED. THANK YOU FOR LISTENING. >> WELL, THANK YOU SO MUCH FOR THOSE COMMENTS. I HAVE TO AGREE WITH YOU. I THINK THAT DESPITE THE FACT THAT WE HAVE THE CARA ACT, I THINK WE HAVE TO BE STEWARDS OF WHAT COMES OUT OF THIS, CERTAINLY THE TASK FORCE WILL PLAY A ROLE IN ENSURING CLARITY CONCERNING US. THOSE ARE THEMES THAT ARE COMING UP OFTEN, AND I DON'T THINK WE SHOULD BE SHY IN SAYING IT TO ENSURE THAT, YOU KNOW, AT EVERY POINT IN WHATEVER MANNER WE'RE ALL WORKING AND THE RELATIONSHIPS WE HAVE PROFESSIONALLY, YOU KNOW, IN ALL THAT REALM, THIS STUFF DOES GET OUT, BECAUSE THERE WERE ALREADY, YOU KNOW, FOLKS WHO YOU'RE TREATING AND I KNOW SOME OF MY OWN PATIENTS WHO GAVE ME THEIR BLESSINGS TO COME HERE BUT ARE ALREADY CONCERNED AND ENCOUNTERING PROBLEMS BECAUSE THEY ACTUALLY LEFT OUR CLINIC AND I'M LIKE, NO, NO, NO, GO BACK TO THE CLINIC BECAUSE MY COLLEAGUES ARE OF THE SAME MIND AND DISCIPLINED BUT THEY HAVE ENCOUNTERED, YOU KNOW, SOME OF THE STIGMA IN CHANGE IN PLANS, BY PEOPLE WHO ARE REALLY TAKING THIS AS A BLACK AND WHITE ISSUE AND WE KNOW IT'S SO MUCH MORE COMPLICATED THAN THAT. ANY OTHER QUESTIONS? GREAT. THANK YOU FOR GIVING ME THE TIME. THAT . >> THANK YOU. THAT WAS REALLY HELPFUL. >> THANKS SO MUCH. NOW WE'RE GOING TO GO ON TO UPDATES FROM THE IPRCC MEMBERS. SHARON, IS SHARON UP THERE ALREADY? GOOD. AND RIC RICCIARDI. >> HELLO, EVERYONE. THANKS FOR GIVING ME THE OPPORTUNITY TO UPDATE YOU ON THE REMS AND THINGS WE'RE DOING AT FDA IN THIS SPACE. OH DEAR. THIS IS WHAT HAPPENS WHEN YOU BORROW SLIDES AND YOU DON'T REALIZE THEY ARE -- OKAY. SO JUST -- I'M NOT GOING FAR BACK IN OUR HISTORY BECAUSE WE'VE BEEN DOING THIS ALL ALONG, BUT 2016 WAS A BIG TIME FOR US IN TERMS OF ORGANIZING MORE OUTWARD FACING ACTION PLAN, HAD A NUMBER OF COMPONENTS, AND I'M GOING TO GO THROUGH JUST BRIEFLY EACH OF THESE COMPONENTS AND WHERE WE ARE. SO AGAIN WE'RE ANOTHER ONE OF THE AGENCIES THAT ARE TRYING TO BALANCE BOTH PATIENT ACCESS BUT BETTER SAFETY. AND IT'S AN ONGOING CHALLENGE. SO WE ESTABLISHED EXTENDED RELEASE AND LONG ACTING OPIOID REMs -- WE HAVE THIS NEW AUTHORITY RELATIVELY BY GOVERNMENT STANDARDS TO REQUIRE REMs, RISK EVALUATION MITIGATION STRATEGIES IMPOSED BY FDA BUT RUN BY SPONSORS IMPLEMENTED BY DRUG MANUFACTURING COMPANIES. WE FOCUSED ON THE EARLY PRODUCTS DURING THE DEVELOPMENT OF THE REMS BECAUSE WE FELT THERE WAS A DISPROPORTIONAL RISK FOR BAD OUTCOMES BASED ON ANALYSES, WE THOUGHT IT WOULD CAPTURE A LARGE NUMBER OF OPIOID PRESCRIBERS IN GENERAL, BASED ON FACTORS WE CALCULATED TO BE 320,000 OR SO. THIS WAS BACK IN 2010, 2011 WHEN WE WERE DOING A LOT OF THESE ANALYSES AND PLANNING HOW TO MOVE FORWARD. THIS WAS A NEW CONCEPT FOR US, THESE LARGE SHARED SYSTEM REMS. PART OF THE REASON FOR US TO FOCUS IT BACK AT THIS STAGE WAS WE DIDN'T KNOW WHAT THE IMPACT WAS GOING TO BE. AND GIVEN THAT IT WAS GOING TO BE THE LARGEST SHARED SYSTEM THAT THE AGENCY HAD EVER REQUIRED, WE WERE AFRAID OF POTENTIAL DISRUPTION TO ACCESS, AMONG OTHER THINGS. SO THE REMS WAS APPROVED IN 2012 AND THE PRIMARY FOCUS WAS PRESCRIBER TRAINING. AND THIS WAS TO BE ACHIEVED BY UNRESTRICTED GRANTS FROM PHARMA TO ACCREDITED C.E. PROVIDERS. AND WE ESTABLISHED A BLUEPRINT TO GUIDE THE C.E. COURSES. BUT THERE WAS ALSO -- THERE WERE ALSO OTHER ELEMENTS, MEDICATION GUIDES FOR PATIENTS, A NEW PATIENT COUNSELING DOCUMENT, AND A VARIETY OF OTHER ELEMENTS. WELL, WE'RE AT THE STAGE NOW WHERE WE CAN START ASSESSING WHAT THIS INITIAL REMS HAS BEEN ABLE TO ACHIEVE. AND WE HELD AN ADVISORY COMMITTEE LAST YEAR, AND THE ASSESSMENTS WERE HOT AND COLD. WE FOUND THAT A LOT OF PEOPLE TOOK THE REMS APPROPRIATE TRAINING, AND REACHING OVER 400,000 HEALTH CARE PROVIDERS. HOWEVER, NOT ALL OF THESE WERE THE IDENTIFIED TARGET POPULATION OF PEOPLE WHO WERE ALREADY PRESCRIBING EARLY OPIOIDS. WE ALSO FOUND AS WON'T BE A SURPRISE TO THIS GROUP IT'S REALLY HARD TO EVALUATE THE EFFECT OF EDUCATION ON THE KEY OUTCOMES THAT WE WERE LOOKING TO IMPACT, IN APPROPRIATE PRESCRIBING WHICH ALONE IS HARD TO DEFINE, ESPECIALLY FROM A DATABASE PERSPECTIVE, THE MISUSE AND ABUSE OF THESE PRODUCTS, AND ALSO IN GENERAL THE DEVELOPMENT OF ADDICTION, UNINTENTIONAL OVERDOSE AND DEATH. SO AT THE ADVISORY COMMITTEE WE SOUGHT INPUT TO FIND OUT HOW WE CAN BETTER DEVELOP METHODOLOGIES TO EVALUATE THE PROGRAM, AND BASICALLY ASKED IF WE SHOULD CHANGE IT AT THIS POINT. AND THEY SAID YES. SO THE AREAS WHERE WE WERE GIVEN ADVICE TO CHANGE AND IN PARTICULAR THAT WE HAVE BEEN WORKING ON IS THERE WAS GENERAL AGREEMENT THAT THE BLUEPRINT WAS TOO FOCUSED ON THE DRUGS THEMSELVES, AND SHOULD BE BROADENED TO INCLUDE CONCEPTS OF PAIN MANAGEMENT BEYOND JUST THE USE OF OPIOIDS. NOW, OF COURSE THAT SEEMS VERY RATIONAL AND HELPFUL. WHEN WE TARGETED TRAINING ON OPIOIDS WE FIGURED WE COULD GET ALL THOSE IMPORTANT SAFETY MESSAGES AND APPROPRIATE USE MESSAGES IN, IN ABOUT TWO TO THREE HOURS. WHICH IS A LOT FOR A BUSY CLINICIAN. WELL, NOW WE HAVE A VERY BROAD BLUEPRINT THAT WILL PROBABLY REQUIRE WELL MORE THAN THAT. BUT THERE MAY BE MANY WAYS TO ACHIEVE IT. IT'S NOT THAT YOU HAVE TO SIT DOWN FOR A MARATHON SESSION OF PAIN MANAGEMENT AND GIVE UP A DAY OR DAYS OF PRACTICE. ALSO, WE WERE ADVISED TO INCLUDE ALL OPIOIDS. AGAIN, INITIALLY WE WERE VERY CONCERNED ABOUT ACCESS, BUT AS WE CONTINUED TO ANALYZE THE DATA ON THE PROBLEMS THAT ARE OCCURRING, IT MAKES SENSE TO INCLUDE THE OPIOIDS, PRESCRIBED MORE FREQUENTLY THAN EXTENDED RELEASE, WE ALSO ASKED FOR OTHER MODIFICATIONS, SO MOVING THOSE RECOMMENDATIONS FORWARD WE'RE STILL FOCUSING REMS ON EDUCATION BUT HOW DO WE DELIVER THAT OR HOW DO WE HELP ENSURE THAT THAT'S DELIVERED TO THE POPULATION THAT NEEDS IT THE MOST? AND THAT'S A VERY CHALLENGING IDEA. AT THIS MEETING THAT WE HELD, WE HEARD VERY LOUDLY FROM SEVERAL CAMPS. EDUCATION SHOULD BE MANDATORY. DO NOT MAKE THIS EDUCATION MANDATORY. IT'S A VERY DIFFICULT CHALLENGE. THERE'S GOOD POINTS ON BOTH SIDES OF THOSE POSITIONS. WE'RE ALSO EXPANDING THE BLUEPRINT TO INCLUDE BROAD CONCEPTS OF PAIN MANAGEMENT. RATHER THAN RECREATED WHEEL, WE TOOK A LOOK AT WHAT WAS GOING ON IN THE COMMUNITY BY ORGANIZATIONS WHO HAD THE EXPERTISE TO INFORM WHAT SHOULD BE INCLUDED IN A PROGRAM FOR PAIN MANAGEMENT EDUCATION. THE BLUEPRINT WENT OUT FOR COMMENT. AND -- LET'S SEE. I STRUGGLED WITH THE ORDER. WE'LL GET BACK TO THE BLUEPRINT IN A MOMENT. AND THEN ALSO AT THE SAME TIME OR, OH, AROUND THE SAME PERIOD WE DECIDED THAT WE WOULD EXPAND THE REMS TO INCLUDE IMMEDIATE RELEASE, NOT JUST THE EXTENDED RELEASE AND LONG ACTING OPIOIDS. SO WE SENT A LETTER OUT NOTIFYING COMPANIES THAT THIS WOULD BE THE CASE IN SEPTEMBER. AND WE'VE ALSO EXPANDED THE TARGET POPULATION FROM NOT JUST PRESCRIBERS BUT TO OTHER MEMBERS OF THE HEALTH CARE TEAM, IN PARTICULAR NURSES AND PHARMACISTS, THAT CAN HELP MANAGE -- THAT HELP MANAGE PATIENTS AND COULD ALSO BENEFIT FROM ADDITIONAL KNOWLEDGE IN THIS AREA. SO THE BLUEPRINT WAS BROADENED PRETTY MUCH AS FAR AS WE THOUGHT NECESSARY. SO THERE'S PRINCIPLES OF PAIN MANAGEMENT. BASICALLY HOW TO EVALUATE A PATIENT, HOW TO CREATE A PLAN FOR MANAGEMENT, WHAT THE RANGE OF THERAPIES ARE, AND HOPEFULLY HOW TO IMPLEMENT THEM, STARTING OR INCLUDING BOTH NON-PHARMACOLOGIC TREATMENTS AS WELL AS NON-OPIOID MEDICATIONS. THE IDEA OF CONSIDERING NOT JUST MULTI-DISCIPLINARY CARE BUT WHERE AVAILABLE INTERDISCIPLINARY CARE. AND THEN WE'VE ALSO INCLUDED SOME BASIC INFORMATION ON ADDICTION MEDICINE AND OPIOID USE DISORDER. HOW DO YOU IDENTIFY A PATIENT AT RISK WHEN YOU START TO MANAGE A PATIENT IN PAIN? WHAT ARE THE SIGNS A PATIENT MAY BE GETTING IN TROUBLE? WHAT INFORMATION SHOULD BE CONVEYED TO PATIENTS WHEN THEY ARE STARTING TO BE MANAGED FOR PAIN THAT THEY NEED TO KNOW TO BE PART OF THIS, AN ACTIVE PARTNER IN THEIR HEALTH CARE AND IN AVOIDING UNFORTUNATE OUTCOMES. SO WE GOT A LOT OF COMMENTS, INCLUDING FROM FOLKS HERE. THANK YOU. AND OVER 600 COMMENTS. WE HAVE A PROCESS FOR THAT. IT'S ONE WE DEVELOPED BACK IN 2010 AND 2011. SO WE FOLLOWED A VERY SIMILAR PROCESS. WE WENT OVER ALL OF THE COMMENTS. THE GROUP WORKING ON THE BLUEPRINT CONSIDERED ALL OF IT. THE BLUEPRINT WILL BE -- IT'S GOING THROUGH CLEARANCE AND WILL BE MADE PUBLIC. WE WILL SHARE THIS AGAIN WITH OUR PARTNERS BUT WE WANT TO GET THIS POSTED. AND PEOPLE MAY NOT BE HAPPY WITH WHAT THEY SEE, THINKING PERHAPS WE DIDN'T TAKE INTO CONSIDERATION ALL OF THE COMMENTS BUT WE DID. THE BIGGEST DIFFERENCE BETWEEN A LOT OF THE COMMENTS WE GOT AND THE FINAL PRODUCT IS WE WERE NOT WRITING A COURSE. WE WERE NOT DEVELOPING THE PROGRAM WE WANTED TO DEVELOP AN OUTLINE FROM WHICH ACCREDITED EDUCATIONAL PARTNERS, ACCREDITED C.E. PROVIDERS, COULD DEVELOP COURSES. SO IT'S NOT THAT ANY OF THOSE COMMENTS WEREN'T CONSIDERED IMPORTANT, BUT A LOT OF THEM WERE WAY DOWN IN THE COURSE CURRICULUM LEVEL. SO WHAT YOU'LL SEE IS A VERY HIGH LEVEL TYPE OF BLUEPRINT. GOING ON TO OTHER AREAS, WE COMPLETED LAST DECEMBER A RELABELING ALL OF THE IMMEDIATE RELEASE OPIOID ANALGESICS, AND THE PRODUCTS THAT ARE GOING TO BE IN THE REMS ARE PRODUCTS THAT ARE USED IN THE OUTPATIENT SETTING. SO WE'RE NOT GOING TO BE INCLUDING, YOU KNOW, PERIOPERATIVE OPIOIDS, INTRAOPERATIVE OPIOIDS IN THE REMS. AND WE'RE ALSO NOT INCLUDING PRODUCTS THAT ARE COVERED BY OTHER RISK EVALUATION AND MITIGATION STRATEGIES, FOR INSTANCE TRANSMUCOSAL FENTANYLS, IMMEDIATE RELEASE FENTANYL. WE UPDATED AND THEY NOW ALL HAVE A MEDICATION GUIDE. YOU KNOW, IT'S A CONSTANT SOURCE OF FRUSTRATION. WE TRY TO MAKE DOCUMENTS USABLE. I KNOW FOR A WHILE OPIOID MEDICATION GUIDE WAS LIKE SIX PAGES LONG. WE'VE GOTTEN IT DOWN TO A SINGLE PAGE. UNFORTUNATELY, THEY ARE NOT ALWAYS DELIVERED. SO THAT'S A CHALLENGE RIGHT THERE. WE'VE DONE SOME ADDITIONAL LABELING CHANGES. WE ISSUED A LABELING CHANGE, SAFETY LABELING CHANGE LETTER. THAT'S WHERE WE REQUIRE CHANGES TO LABELING BASED ON SAFETY FINDINGS, A SERIES OF CRITERIA IDENTIFYING WHEN IT'S APPROPRIATE BUT WE'VE BEEN LOOKING IN PARTICULAR AT THE INCREASED RISKS ASSOCIATED WITH CONCOMITANT USE OF BENZODIAZEPINES AND OTHER DEPRESSANTS, WARNINGS HAVE BEEN EXPANDED AND GIVEN MORE DETAIL. AND MORE RECENTLY, WE'VE UPDATED THE LABELING FOR THE AGONIST TREATMENTS, THE MEDICATION ASSISTED TREATMENTS FOR OPIOID USE DISORDER. THIS IS AN INTERESTING SITUATION. WE HAVE SIMILAR RISKS BECAUSE METHADONE AND BEAUTIFUL NOR PHENE ARE USED FOR PAINING MANAGEMENT. THE LABELS ARE NOT THE SAME, THE POPULATIONS ARE NOT THE SAME. THE RISK OF MANAGING SOMEONE WITH OPIOID USE DISORDER AND PAIN HAVE DIFFERENT WEIGHTS BASED ON SITUATION, IT'S NOT ONE SIZE FITS ALL. YOU'LL NOTICE THERE ARE DIFFERENCES IN THE LABELING EVEN FOR COMMON RISK, AN ATTEMPT TO NOT CREATE UNINTENDED CONSEQUENCES. FOR INSTANCE, SOMEBODY'S ON A BENZODIAZEPINE YOU NEED TO TREAT OPIOID USE DISORDER. YOU CAN'T NOT TREAT THEM. THAT'S THE SORT OF PROBLEM WE TRIED TO AVOID WHEN WE DID THIS MORE RECENT LABELING. WE HAVE TEN ABUSE DETERRENT OPIOID FORMULATIONS. ONE IMMEDIATE RELEASE AND NINE EXTENDED RELEASE. CHALLENGE WITH THESE PRODUCTS IS -- OH, THERE'S MULTIPLE CHALLENGES. ONE IS WE DO A LOT OF WORK PRE-MARKETING TO TRY AND PREDICT WHAT MIGHT BE CHARACTERISTICS OF THESE FORMULATIONS THAT WILL MAKE THEM LESS APPEALING FOR ABUSE. BUT UNFORTUNATELY, THE MESSAGE THAT'S BEING CONVEYED THAT WE'RE HEARING GETTING FEEDBACK FROM, THE COMMUNITIES, IS THAT THEY ARE LESS ADDICTIVE, WHICH IS COMPLETELY INACCURATE. THEY ARE SCHEDULE 2 AND 3 OPIOIDS, POTENTIAL FOR ADDICTION HASN'T CHANGED. THE ABILITY TO MANIPULATE PRODUCTS FOR ABUSE BY ROUTES OTHER THAN THE ROUTE INTENDED IS WHAT'S BEING CHANGED. SO CONTINUING TO WORK ON THAT. THIS IS A REALLY CHALLENGING TASK. WE'VE BEEN TOLD BY MANY PEOPLE AND REQUESTED BY MANY GROUPS TO CHANGE THE WAY WE LOOK AT THE RISK AND BENEFIT OF OPIOID ANALGESICS TO TRY AND TAKE INTO CONSIDERATION PUBLIC HEALTH. WELL, WE HAVE BEEN FOR MY WHOLE TIME HERE. OPIOIDS ARE INHERENTLY OPIOIDS, WHEN WE PUT SCHEDULE 2 ON TOP OF THE LABEL THE HOPE IS THE PRESCRIBER WILL UNDERSTAND WHAT THAT MEANS, AND WILL USE THE MEDICATION ACCORDINGLY. THAT HASN'T WORKED OUT SO WELL. SO WE HAVE BEEN GROWING A PROGRESSIVELY LONGER BOXED WARNING ON THESE PRODUCTS, TRYING TO GET PEOPLE'S ATTENTION. WE SOUGHT INPUT FOR HOW TO FURTHER IMPROVE OUR ABILITY TO TAKE OR BALANCE RISK AND BENEFIT. SO WE SOUGHT INPUT FROM NATIONAL ACADEMY OF SCIENCE, ENGINEERING AND MEDICINE, TO HELP. THIS WAS A FOLLOW-UP FROM THE -- I FORGET IF IT'S 2010 OR 2011 REPORT, PAIN IN AMERICA. AND WE GOT INTERESTING AND USEFUL INFORMATION FROM THE LATEST REPORT. NOT SO MUCH IN TERMS OF CONCRETE CONCEPTS FOR HOW TO MODIFY THE RISK/BENEFIT FRAMEWORK, AND WE'RE CONTINUING TO WORK ON THAT. IT'S AN ACTIVE AREA OF WORK FOR US INSIDE THE AGENCY. AND BUT I CAN TELL YOU THAT WE ARE ALWAYS TAKING THE PUBLIC HEALTH INTO CONSIDERATION. FOR INSTANCE, WE RECENTLY REQUESTED THAT EXTENDED RELEASE OPANA, AN OXYMORPHONE PRODUCT BE REMOVED FROM THE MARKET BECAUSE NOT ALL OXY MORPHONE PRODUCTS, THIS PARTICULAR PRODUCT, BECAUSE WE WERE FINDING SIGNALS THAT IT WAS CREATING HARM IN THE POPULATION THAT WAS USING THE PRODUCT. CLEARLY IT'S NOT INDICATED FOR ABUSE. THESE PEOPLE ARE OBTAINING THE PRODUCT ILLEGALLY AND/OR INAPPROPRIATELY BUT THEY WERE BEING HARMED BY ELEMENTS OF THE FORMULATION. SO WENT TO ADVISORY COMMITTEE TO GET INPUT. THERE WAS GENERAL AGREEMENT THAT THE RISK -- BENEFITS NO LONGER OUTWEIGHED THE RISKS FOR THIS PARTICULAR PRODUCT, AND IT IS COMING OFF THE MARKET. MOST MARKETING ASSESSMENT IS UNDERSTANDING WHAT'S GOING ON OUT IN THE WORLD WITH THESE PRODUCTS IS EXTREMELY DIFFICULT. MANY, MANY CHALLENGES AND ASSESSING PATTERNS OF ADDUCTION HAVE LIMITATIONS AND WE TRY TO COUPLE TOGETHER AS COMPLETE A PICTURE AS POSSIBLE, USING A VARIETY OF DATA. TO HELP US, WE CONVENED A PUBLIC WORKSHOP IN JULY OF THIS YEAR, AND THIS IS THE TITLE. SO I THINK IT IS ALSO PRETTY SELF-EXPLANATORY. DATA AND METHODS FOR EVALUATING IMPACT OF OPIOID FORMULATION WITH PROPERTIES DESIGNED TO DETER ABUSE IN POSTMARKET SETTING, HELPING WITH ASPECTS OF UNDERSTANDING IMPACT OF DIFFERENT PRODUCTS IN THE COMMUNITY BECAUSE IT TALKS ABOUT -- THEY DISCUSSED THE AVAILABLE DATA SOURCES, WHERE WERE WERE GAPS, WHERE WE COULD STAND FOR IMPROVEMENTS. AND ADVISORY COMMITTEE MEETINGS, THAT'S ANOTHER PIECE OF THE ACTION PLAN. INITIALLY WE WERE DIRECTED TO TAKE ALL NON-ABUSE DETERRENT AND PEDIATRIC OPIOID APPLICATIONS TO ADVISORY COMMITTEE, AND IN PRACTICE WE'RE TAKING ALL OPIOIDS TO ADVISORY COMMITTEE, INCLUDING ABUSE DETERRENT PRODUCTS, BECAUSE THE SCIENCE IS RELATIVELY NEW, AND EACH PRODUCT AND EACH FORMULATION HAS ITS OWN UNIQUE ISSUES. IN THE WAKE OF THE OPANA E.R. EXPERIENCE WE'RE TRYING TO GET A BETTER SENSE OF THE UNINTENDED CONSEQUENCE OF PEOPLE MANAGING TO DEFEAT THE ABUSE DETERRENT CHARACTERISTIC AND WHEN THEY ARE SUCCESSFUL AND LET'S FACE IT, THE PRODUCTS ARE INTENDED TO DELIVER AN OPIOID, ONE WAY OR ANOTHER YOU CAN GET THE OPIOID OUT. IT'S JUST WHAT GOES WITH IT. AND WILL THOSE OTHER COMPONENTS CREATE HARM. THERE'S A LOT OF INTEREST IN THE ADVISORY COMMITTEE ABOUT THAT AND IT'S ANOTHER AREA OF FOCUS FOR US AS THESE PRODUCTS GO THROUGH DEVELOPMENT. WE ARE TRYING TO DO WHAT WE CAN TO PARTNER WITH NIDA AND PROGRAMS FOR ACCELERATEDNG DEVELOPMENT. YOU MAY KNOW THE FIRST MODIFIED RELEASE WAS RELEASED LAST YEAR, THAT WAS IMPLANTABLE -- BUPORNOPHEN THAT'S NOT THE TECHNICAL TERM. WE'RE GOING TO VALENTINE'S DAY COMMITTEE FOR THOSE, THAT'S BEEN MADE PUBLIC, COMING UP SHORTLY. THERE'S A LOT OF REALLY INTERESTING TOPICS AND FOR ANY OF YOU WORKING THIS AREA I HIGHLY RECOMMEND THAT YOU -- IF YOU CAN'T ATTEND, CERTAINLY TRY TO REGISTER FOR THE WEBEX OR VIDEO COMMUNICATION FOR THE ADVISORY COMMITTEE, AND IF THAT'S NOT SOMETHING THAT YOU CAN DO, THERE WILL BE NOT ONLY MEETING MINUTES PUBLISHED BUT THERE WILL BE A FULL TRANSCRIPT ULTIMATELY PUBLISHED. THIS IS GOING TO BE INTERESTING AS WE TALK ABOUT EFFICACY IN THE CONTEXT OF VERY LONG-ACTING PRODUCTS WHAT RISK MANAGEMENT LOOKS LIKE IN DEPOT FORMULATION. ANOTHER NEW ELEMENT TO FDA'S OVERALL ACTION PLAN IS DEVELOPMENT OF THE STEERING COMMITTEE, THE COMMISSIONER ESTABLISHED THIS COMMITTEE TO EXAMINE REGULATORY AND POLICY ACTIONS TO COMBAT THE CRISIS. THIS INCLUDES TRYING TO FIGURE OUT WHETHER WE ARE THE RIGHT AGENCY TO IMPLEMENT MANDATORY EDUCATION AND HOW TO PURSUE A GOAL, THROUGH THE REMS THE PROBLEMS HAVE BEEN PRESENTED IN A NUMBER MUCH SETTINGS IT WOULD BE ADMINISTRATION AND OVERSEEN BY PHARMA, ONE OF THE CHIEF PROBLEMS. NOW, IT IS THROUGH INDEPENDENT GRANTS BUT PHARMA WOULD BE MANAGING THIS DATABASE AND IT'S NOT AN IDEAL SITUATION. WE HAVE GONE ON TO PUBLISH A DOCKET TO GET ADDITIONAL INFORMATION ON THIS TOPIC. HERE IS THE DOCKET NUMBER. AND THIS GROUP IS ALSO WORKING ON EFFORTS TO REDUCE THE NUMBER OF NEW CASES OF ADDICTION. SO HOW CAN WE DEAL WITH THE PROBLEMS THAT ARE ONGOING AND HOW CAN WE PREVENT FEEDING THE PROBLEM WITH NEW ENTRANTS. SO THIS IS ALL PART OF OUR ONGOING WORK. LET'S SEE. OKAY. SO WE'RE GOING TO CONTINUE USING ALL THE AVAILABLE AUTHORITIES THAT WE HAVE TO TRY AND HELP ADDRESS PROBLEMS WITH PRESCRIPTION OPIOID ABUSE. THERE'S A LOT OF COORDINATED WORK WITHIN FDA AMONG DIFFERENT OFFICES. AND ALSO WE'LL CONTINUE TO WORK AS MUCH AS WE CAN WITH OUR FEDERAL AND NON-FEDERAL PARTNERS. THANKS. ANY QUESTIONS? >> SO THANK YOU. THIS IS AN ENORMOUS AMOUNT OF WORK. I REALIZE YOU'RE NOT PUTTING TOGETHER THE CURRICULUM BUT I'D LIKE TO PUT A WORD IN. THE CHALLENGE THE BOX WARNING ABOUT BENZOS AND OPIOIDS IS IMPORTANT. BUT A BENZOIS NOT A BENZOIS NOT A BENZO. BENZODIAZEPINE. MANY PEOPLE WITH SERIOUS ILLNESS HAVE ADJUSTMENT DISORDER TO BEING DIAGNOSED WITH SCARY DISEASE AND MAY BE ON LOW DOSE OF CLONOZOPAN AS OPPOSED TO AL P RAZOLAM THAT HAS THE RISK. MOST HEALTH CARE PROFESSIONALS& DON'T KNOW THAT. IT'S A HARD THING TO ADD TO THE REMS, AS YOU INDICATED IT'S ALREADY REALLY PACKED AGENDA BUT WE ALL NEED TO KNOW A LOT MORE ABOUT THE DIFFERENCES BETWEEN THE BENZODIAZEPINES. >> WE'RE HOPEFUL THIS TYPE OF DETAIL WILL COME OUT BY THOUGHTFUL CREATION OF THESE PROGRAMS. WE DID NOT USE A CONTRAINDICATION IN LABELING FOR THE CONCOMITANT USE BUT DID SAY AVOID IT WHENEVER POSSIBLE. IT'S VERY HARD TO ANTICIPATE IMPACT OF LABELING. GENERALLY IT EITHER HAS NO IMPACT, IT SEEMS. HENCE THE GROWING BOXED WARNING FOR ALL OF THESE OPIOID ANALGESICS. OR SOMETIMES IT SEEMS TO HAVE AN UNINTENDED CONSEQUENCE WHERE PEOPLE SIMPLY SAY, OKAY, WE'RE NOT SUPPOSED TO DO THIS. THEREFORE WE WILL TREAT IT LIKE A CONTRAINDICATION. AND THAT'S A CHALLENGING BALANCE THAT IS ALWAYS AN ONGOING STRUGGLE. SO I THINK YOU MAKE A VERY GOOD POINT. I'M NOT SURE HOW MUCH WE CAN INTERVENE WITH THAT LEVEL OF DETAIL. >> SHARON, DO YOU KNOW WHETHER THE DIFFERENT HEALTH CARE CURRICULUM INCORPORATE REMS COURSES AS A CRITERIA FOR GRADUATION ASSESSMENT OF COMPETENCY? IT JUST SEEMS THAT, YOU KNOW, WE'RE TRYING TO EDUCATE INDIVIDUALS WHO ARE ALREADY OUT OF THE BOX, RATHER THAN INTRODUCING THESE TO HEALTH CARE PROFESSIONALS WHO GIVEN THE DEARTH OF, YOU KNOW, DIDACTIC, THIS SEEMS IT SHOULD BE AN ACCREDITATION PROCESS TO PRESCRIBE OPIOIDS OR EVEN OPIOID-LIKE SUBSTANCES. I'M JUST WONDERING WHETHER THIS EFFORT SHOULD ALSO EXTEND AT LEAST THE GUIDELINES THAT COULD THEN BE DEVELOPED INTO COURSE WORK, C.E. COURSES AT THE UNIVERSITY LEVEL, HEALTH CARE PROVIDER LEVEL, THAT REALLY BEGIN TO IMPACT LARGE NUMBERS OF INDIVIDUALS HEADING TO PRIMARY CARE AND OTHER AREAS OF HEALTH CARE. >> I CAN'T AGREE WITH YOUR CONCEPT MORE. SO FDA HAS AUTHORITY TO REGULATE INDUSTRY. AND THAT'S AS FAR AS OUR AUTHORITY GOES. SO WE CAN'T REALLY GET TO MEDICAL EDUCATION ACCREDITING BODIES DIRECTLY. THE FACT THAT OUR OPIOID REMS BLUEPRINT HAS EXPANDED WILL HOPEFULLY BE NOTICED BY OTHERS, BUT THAT'S A TOUGH ONE FOR US TO DIRECTLY INTERVENE OR EVEN INDIRECTLY INTERVENE IN A MEANINGFUL WAY. DAN? >> JUST AS A SIDE COMMENT FOR PEOPLE'S INFORMATION, GOVERNOR BAKER IN MASSACHUSETTS TWO OR THREE YEARS AGO CONVENED THE DEANS OF THE FOUR MEDICAL SCHOOLS WITHIN MASSACHUSETTS TO DEVELOP SHARED COMPETENCIES ON PAIN AND ADDICTION. IT WOUND UP AT THE END OF THE DAY IT WAS MORE EMPHASIS ON ADDICTION THAN PAIN BUT BOTH WERE COVERED AND THE IDEA IS EXACTLY TO DR. MIXNERS POINT GRADUATES INITIALLY OF MEDICAL SCHOOLS WOULD BE HELD TO A STANDARD OF DISCIPLINING COMPETENCY IN A SERIES OF STEPS THAT WOULD CORRESPOND TO REMS IF YOU WERE TO BRING IT DOWN TO A MEDICAL STUDENT LEVEL. THIS WAS FOLLOWED BY SIMILAR PANELS THAT DEVELOPED COMPETENCIES FOR DENTISTRY AND NURSING. IT'S EXTENDING INTO SOCIAL SERVICE AND OTHER GROUPS AS WELL. SO AS A POINT OF INFORMATION THIS IS PUBLIC ACCESS. IT WAS RELEASED LAST YEAR AND IF IT'S RELEVANT TO THE DELIBERATIONS I'D BE HAPPY TO PROVIDE THE LINK. >> YOU KNOW, IT'S INTERESTING BECAUSE WE'RE NOT CREATING THIS. LIKE I SAID, WE ARE TRYING TO LEVERAGE THE WORK THAT HAS BEEN DONE BY PEOPLE WHO ARE MORE KNOWLEDGEABLE ABOUT WHAT SHOULD BE IN A CURRICULUM. WE JUST BORROWED THOSE CONCEPTS IN A BROAD SENSE. SO IT'S OUT THERE NOW FOR THE PRACTICING PHYSICIAN. SO CERTAIN STATES ARE NOW MANDATING EDUCATION IN THIS AREA. A NUMBER OF ORGANIZATIONS HAVE COURSE WORK FOR NON-PAIN SPECIALISTS. AND SO AS THIS CONCEPT SPREADS AND HOPEFULLY THE REMS IS ONE MECHANISM FOR SPREADING IT, THE REALIZATION THAT YOU REALLY HAVE TO START IN MEDICAL EDUCATION, IN NURSING EDUCATION, IN PHARMACY EDUCATION, YOU HAVE TO START AT THE VERY BEGINNING OF THE EDUCATION PROCESS, SO THAT PEOPLE COME OUT AND START PRACTICING WITH THIS CLEARLY IN MIND. I CAN'T AGREE WITH THAT MORE. >> I KNOW YOU'RE IN A VERY DIFFICULT POSITION IN TRYING TO BALANCE THE ISSUE OF PATIENTS AND PATIENT ACCESS WITH ABUSE AND WHAT'S GOING ON NOW WITH THE OPIOID CRISIS. I WONDERED IF THE FDA HAS FORMAL PROS PROCESS FOR PATIENT INFORMATION. THE PATIENT COMMUNITY FEELS LIKE THE SCALES HAVE TIPPED AND ACCESS IS INCREDIBLY DIFFICULT AND THE CONVERSATION LOOKS LIKE ALSO ALMOST ALL FOCUSED ON THE HE ILLEGITIMATE USE RATHER THAN THE PREDOMINANT 90% OF THE POPULATION USING APPROPRIATELY, IT FEELS LIKE THE SCALES TIPPED AND WE DON'T HAVE A FORMAL WAY OF GETTING PATIENT INPUT INTO THE FDA PROCESS. >> SO THE INPUT THAT WE GOT FROM THE BLUEPRINT, WE'RE VERY GLAD TO SEE A LOT OF INPUT FROM PATIENT ADVOCACY GROUPS. WE HAD INPUT FROM FEDERAL PARTNERS. WE HAD INPUT FROM MEDICAL ORGANIZATIONS. PHARMACY ORGANIZATIONS, PATIENT ORGANIZATIONS. EVERYBODY HAD AN EQUAL WEIGHT. PATIENT INPUT WAS AS IMPORTANT AS ANYTHING ELSE. WE HAD QUITE A BIT OF IT. WE HAVE PATIENT REP AND CONSUMER REP ON OUR ADVISORY COMMITTEES ALWAYS, AND OFTEN WE HAVE MORE THAN ONE BECAUSE WHEN WE CONVENE THESE ADVISORY COMMITTEES THEY ARE OFTEN JOINT COMMITTEES OF OUR ANESTHESIA AND ANALGESIA ADVISORY COMMITTEE, AS WELL AS THE DRUG SAFETY AND RISK MANAGEMENT COMMITTEE. SO WE'RE TRYING TO MAKE SURE THAT THE ASPECT OF THE FACT THAT THESE ARE IMPORTANT MEDICATIONS FOR MANAGING PAIN IS NOT LOST. WE'VE HAD A NUMBER OF REQUESTS THROUGH CITIZEN PETITIONS AND OTHER MEANS TOO MAKE CHANGES YOU CAN SEE WERE MADE PUBLIC, WE HAVE FELT POTENTIALLY MORE HARMFUL TO PATIENTS THAN BENEFICIAL TO BROADER SOCIETY. WE'RE TRYING VERY HARD. THINK THE MESSAGE IS VERY POORLY COMMUNICATED, BUT WE REGULATE INDUSTRY BUT OUR RESPONSIBILITY IS TO THE PUBLIC. AND TO PROVIDING ACCESS TO NEW AND EXISTING MEDICATIONS. SO I DON'T KNOW HOW TO GET THE PUBLIC CONVERSATION SHIFTED MORE INTO A BALANCED WAY, BUT I CAN TELL YOU THAT WITHIN THE AGENCY OUR DELIBERATIONS VERY MUCH TRY TO INCLUDE WHY THESE MEDICATIONS SHOULD NOT SIMPLY ALL BE TAKEN OFF THE MARKET. SURE, WE CAN NIP THIS WHOLE THING IN THE BUD. NO MORE OPIOIDS. BUT WHAT IS THAT OUTCOME? THAT'S NOT AN ACCEPTABLE OUTCOME. AND THAT'S WHY EVEN WHEN WE WERE THINKING ABOUT THE RISKS ASSOCIATED WITH EXTENDED RELEASE OXYMORPHONE, IT WAS A PRODUCT-SPECIFIC RISK. NOT A DRUG SUBSTANCE RISK. WE'RE TRYING TO MAKE SURE OUR ACTIONS TO THE EXTENT THAT THEY WERE INTERPRETED THE WAY THEY ARE INTENDED ARE SO THAT ACCESS IS PRESERVED. >> THANKS. >> OKAY, THANKS VERY MUCH, SHARON. THAT WAS VERY INFORMATIVE. >> I WAS WONDERING BEFORE WE GO ON, THE COUPLE COMMENTS CAME AROUND TO THE MEDICAL SCHOOL AND IT'S NOT THE FDA'S PURVIEW BUT I WONDER IF PEOPLE THINK WE GOT THE AAMC PEOPLE HERE, AND FIND OUT WHAT THEY ARE DOING AND MAYBE GIVE THEM SOME ADVICE, WHETHER THAT WOULD BE GOOD. BECAUSE THEY ARE IN TOWN. >> I THINK THAT WOULD BE A GREAT IDEA. ALSO-- BUT IT'S ALSO HAPPENING, THERE'S A CONSIDERABLE AMOUNT OF MOMENTUM AND ANOTHER GROUP MIGHT BE PUBLIC HEALTH GROUPS LIKE THE AMERICAN PUBLIC HEALTH ASSOCIATION. I MEAN, THERE'S AN ENORMOUS AMOUNT OF MOMENTUM AND AS YOU ALL KNOW ENORMOUS AMOUNTS TO SOME DEGREE DISCOORDINATED INITIATIVES TAKING PLACE. >> WHAT ABOUT MEDICAL SCHOOL DEANS? BECAUSE AS WE KNOW, IN ACADEMIA IN THIS COUNTRY, AND FOR GOOD REASON, THERE'S A LOT OF INDEPENDENCE AND ACADEMIA WANTS TO MAINTAIN THEIR CONTROL OF THE CURRICULUM. AND SO I THINK THAT, WELL, DAN POINTED OUT GOVERNOR BAKER HAD A COMMISSION, I WAS PART OF WRITING THE LANGUAGE OF THAT COMMISSION. UNFORTUNATELY THE COMMISSION ENDED UP ALMOST NOT USING ANY PAIN CONTENT. IT WAS ALL ON OPIOID PRESCRIBING. EVEN THOUGH IT WAS SUPPOSED TO BE A PAIN MANAGEMENT AND OPIOID COMMISSION. AND EVEN THEN, YOU'RE NOT SURE HOW MUCH THE DEANS REALLY THE CURRICULUM. THAT ENDS UP IN- SO I REALLY THINK ULTIMATELY IT'S THE DEANS OF MEDICAL SCHOOL AND I DON'T KNOW WHERE THESE PEOPLE GO TO FOR GENERAL MEETINGS OR ASSOCIATIONS OR WHATEVER BUT THE LACK OF PAIN MANAGEMENT THERE AND I GUESS THE OTHER PLACE IS IN THE ACCREDITING EXAM WHICH I THINK SCOTT FISHMAN, YOU KNOW, HAD DEALT WITH CORE COMPETENCY WORK. CORE COMPETENCY WORK IS FABULOUS. IT'S NOT BEING USED, NOT BEING INTEGRATED INTO MEDICAL SCHOOL CURRICULUMS. IF WE CAN GET TO THE DEANS WITH THE WORK WHICH IS EXCELLENT AND INTERDISCIPLINARY, THE GOVERNORS ARE CONCERNED ABOUT ONE THING, THEY ARE NOT CONCERNED ABOUT PAIN. WE KNOW WHAT THEY ARE CONCERNED ABOUT. >> A COMMENT AND WE NEED TO MOVE. >> AND I THINK IT'S IMPORTANT TO GET IT AT MEDICAL SCHOOLS. WE TRIED TO DO THAT 15 YEARS AGO. THERE WAS ANOTHER PROJECT FUNDED, IT NEVER HAPPENED BECAUSE THEY SAID THERE'S NO ROOM IN THE CURRICULUM. BUT I THINK THE PROBLEM TODAY WITH ACCESS IS THE PEOPLE PRACTICING. YOU NEED TO GET FAMILY PHYSICIANS, NURSE PRACTITIONERS WHO ARE PRESCRIBING NOW AND EDUCATE THEM, NOT THE ONES WHO WILL BE -- PEOPLE ARE SUFFERING TODAY, NOT EIGHT YEARS FROM NOW WHEN THESE GUYS GRADUATE. I THINK IF YOU'RE LOOKING AT CHANGING MOMENTUM YOU NEED TO TALK TO THE ONES PRACTICING TODAY. BECAUSE THEY DON'T UNDERSTAND A LOT. >> IS RIC HERE? HERE WE GO. >> SINCE I DON'T HAVE ANY SLIDES WOULD IT BE OKAY IF I JUST STAY HERE? >> FINE. >> IT WILL SPEED THINGS UP A LITTLE BIT. AS YOU RECALL I'M A SCIENTIST AT THE AGENCY FOR HEALTH CARE RESEARCH AND QUALITY. I'M JUST GOING TO BRIEFLY MENTION THREE THINGS. ONE THING IS A FOLLOW-UP. YOU PROBABLY RECALL AT THE LAST MEETING, IF YOU READ THE MINUTES WHICH I KNOW YOU DID THERE WAS DISCUSSION ON THE NON-INVASIVE NON-PHARMACOLOGICAL TREATMENT FOR CHRONIC PAIN SYSTEMATIC REVIEW THAT IS ONGOING RIGHT NOW. I WAS HOPING TO HAVE THAT FOR THIS MEETING. HOWEVER, IT'S A GOOD THING BECAUSE IN THE ANALYSIS PORTION GOING ON RIGHT NOW THE EVIDENCE-BASED PRACTICE CENTER IS LOOKING TO TEASE OUT SOME SUBPOPULATIONS, SO THEY ARE DOING ADDITIONAL ANALYSIS ON THE ORIGINAL ANALYTIC PLAN WHICH WAS POSTED. THANK YOU ALL FOR MAKING YOUR COMMENTS ON THE ANALYTIC PLAN AS WELL AS RESEARCH QUESTIONS FOR THE CONDITIONS THAT ARE UNDER STUDY. SO A LITTLE BIT OF A SETBACK. HOWEVER, IT'S A GOOD THING. BECAUSE I THINK WE'LL HAVE A MORE MEANINGFUL SUMMARY OF THE RESULTS BASED ON THE SUBPOPULATIONS THAT THEY ARE TRYING TO SEE IF THERE'S ANY EFFECT. AND I'M HAPPY TO TAKE ANY QUESTIONS ON THAT. WHAT I WILL DO, LINDA, SEND YOU THE LINK ONCE THE DRAFT BECOMES PUBLIC. THE FIRST PUBLICATION WILL BE A DRAFT. AND THEN IT'S OPEN FOR COMMENTS. YOU ALL PLEASE MAKE COMMENTS ON THAT AND THEN YOU HEARD HOW WE DO IN GOVERNMENT WITH COMMENTS. WE TAKE THEM ALL VERY SERIOUSLY. WE SYNTHESIZE AND PROVIDE FEEDBACK. THE SECOND THING I WANT TO HIGHLIGHT, TWO NO RECENT DEVELOPMENTS, TWO WEEKS AGO WE DID AN ENVIRONMENTAL SCAN. AHRQ HAS AN INTEREST IN PRIMARY CARE. AND WE HAVE SOMETHING CALLED THE ACADEMY, WHICH IS A KNOWLEDGE BASE OF TRYING TO INTEGRATE MENTAL HEALTH INTO PRIMARY CARE, HOW CAN PRIMARY CARE WORK BETTER WITH MENTAL HEALTH CENTERS, HOW CAN MENTAL HEALTH CENTERS INTEGRATE WITH PRIMARY CARE. THERE'S A TOX TAXONOMY. WE HAVE FIVE GRANTS AROUND MEDICATION ASSISTED THERAPY IN RURAL PRIMARY CARE PRACTICES. A PRODUCT OF THAT IS AN ENVIRONMENTAL SCAN ON MAT FOR OPIOID USE. WE'RE NOT ABOUT MAT OR OPIOID USE. HOWEVER, THAT SCAN IN VOLUME 2 HAS A TREASURE CHEST OF ALL DIFFERENT KINDS OF WAYS TO ASSESS PAIN, DIFFERENT ORGANIZATIONS, WHAT ARE SOME OF THE BEST PRACTICES, AND THAT MIGHT BE HELPFUL TO LOOK AT. I'LL SEND YOU, LINDA, THE LINK TO THE ENVIRONMENTAL SCAN. THE LAST THING I'D LIKE TO MENTION, A REAL SUCCESS FOREFOR STORY FOR US, PROVIDERS, THIS IS A VERY TOUCHY AREA, USE OF THE ELECTRONIC HEALTH RECORD TO DO SYSTEMATIC IMPROVEMENTS AND TO DO QUALITY IMPROVEMENT IS REALLY HERE TO STAY. SO USING CLINICAL DECISION SUPPORT, WHETHER IT'S EHR, WHETHER IT'S AN APP, WHETHER IT'S A PATIENT DRIVEN APP, ALL KINDS OF WAYS, WE HAVE A WAREHOUSE COORDINATING THAT WITH THE ONC ON DEVELOPING CLINICAL DECISION SUPPORT. I PUSHED AND PITCHED THIS FORWARD BASED ON WORK OF THIS COMMITTEE AND THE NIH PAIN CONSORTIUM, AND OTHER GROUPS, CDC, RELATED TO THE TREATMENT GUIDELINES AND THE WORK IN THE DoD AND V.A. THE SECOND PART OF THE CONTRACT, A TWO-YEAR CONTRACT TO DEVELOP CLINICAL DECISION SUPPORT WILL BE ON THE MANAGEMENT OF CHRONIC PAIN AND ALSO THE PRESCRIBING OF OPIOIDS. SO THAT IS IN ITS VERY EARLY STAGES, MITRE IS DOING AN ENVIRONMENTAL SCAN BASED ON WHAT I SENT THEM. WHATEVER YOU HAVE AROUND THAT AREA PLEASE SEND IT TO ME, I'LL SEND IT TO MITRE. WHAT WE'RE TRYING TO DO IS DEVELOP CLINICAL DECISION SUPPORT TO ASSIST PROVIDERS TO PROVIDERS PRESCRIBING PRACTICE IN PREVENTION AND MANAGEMENT OF NONMALIGNANT CHRONIC PAIN. I'LL SENT THE LINK TO THE WEBSITE FOR THOSE INTERESTED IN THAT WORK. MY COLLEAGUE IS ED LOMATIN WHO IS A PHYSICIAN INFORMATICKIST IST WHO WORKS AT AHRQ. WE'RE EXCITED ABOUT THESE. I'LL STOP THERE UNLESS WE HAVE ANY QUESTIONS. >> GREAT, THANKS, RIC. I'LL MAKE SURE THE INFORMATION GETS TO THE COMMITTEE. SEND THAT TO ME. GOOD. THINGS ARE MOVING ALONG. >> RIC, DO YOU KNOW IF THERE ARE ANY PARTICULAR HOSPITALS OR HEALTH CARE SYSTEMS THAT PICKED IT UP AND ARE USING IT AS KIND OF TEST CASE? >> CLINICAL DECISION. >> YEAH, YEAH, FOR PAIN. >> WE'RE DEVELOPING IT. THE WAY THIS WORKS, YOU TAKE BEST PRACTICE GUIDELINES, TRANSLATE THE TEXT INTO ARTIFACTS, THE ARTIFACTS BECOME DIFFERENT KINDS OF PROGRAMMING MATERIALS THAT CAN BE USED. AND THE CDS CONNECT IS GOING TO BE A REPOSITORY FOR A VARIETY OF DIFFERENT TYPES OF ARTIFACTS. SO THAT THEY WILL BE IN THE PUBLIC DOMAIN, SOME WE WILL PILOT TEST BECAUSE THAT WILL BE PART OF OUR CONTRACT, BUT HOWEVER THE END RESULT WILL BE PUTTING ARTIFACTING INTO THE PUBLIC DOMAIN, NO MATTER THE APP THEY CAN BE INCORPORATED INTO ELECTRONIC HEALTH RECORDS. I'LL LET YOU KNOW AS SOON AS I KNOW WHO WE'RE GOING TO PILOT TEST ON. RIGHT NOW NOTICE THE EARLY STAGES OF DEVELOPMENT IDENTIFYING BEST PRACTICES, WHAT'S THE EVIDENCE TO DEVELOP CLINICAL DECISION SUPPORT ONCE WE HAVE THAT, THEN WE CAN DEVELOP THE ARTIFACTS. IT'S EVOLVING SCIENCE. CLINICAL DECISION SUPPORT IS VERY MUCH IN ITS INFANCY IN A LOT OF WAYS. I KNOW WE ALL HATE THE ALERTS. BUT HOWEVER THOSE -- WHETHER IT'S DIAGNOSTIC OR THERAPEUTIC, THOSE ARE TWO RICH AREAS FOR CLINICAL DECISION SUPPORT TOO. THAT REALLY ARE IN THE -- PARTICULARLY DIAGNOSTIC CLINICAL DECISION SUPPORT IS IN THE VERY EARLY STAGES OF ASSISTING PROVIDERS TO MAKE DIAGNOSIS. THAT WILL BE INCORPORATED ALSO IN TERMS OF THE PAIN ASSESSMENT. HOPEFULLY THAT ANSWERS YOUR QUESTION. >> SINCE THIS IS AT THE VERY EARLY STAGES I WONDER IF YOU HAVE BROAD PHILOSOPHY HOW TO FACTOR IN THE DIFFERING DURATIONS OF TRIALS OR DIFFERENT INTERVENTIONS THAT MIGHT ULTIMATELY WIND UP BECOMING PART OF A RECOMMENDATION, BECAUSE THIS WAS THE TOPIC THAT WAS TRIGGERED IN THE CONSIDERATION OF THE CDC GUIDELINES, DO YOU SIMILARLY NOT COUNT BEHAVIORAL INTERVENTION LESS THAN A YEAR THAT DON'T GO TO A YEAR, I'M SURE THIS IS NOT A UNIQUE SITUATION. I WONDER IF THERE'S ANY PHILOSOPHICAL ORIENTATION TOWARDS THAT? >> THERE WILL BE DEFINITIONS BASED ON WHAT WE HAVE RECOMMENDED HERE IN THIS COMMITTEE IN TERMS OF WHAT ARE SOME OF THE FUNDAMENTAL AREAS THAT WILL BE IN THE INCLUSION AND EXCLUSION CRITERIA BASED ON, YOU KNOW, WHAT WE PUT OUT THERE. HOWEVER, THE CHALLENGE WITH CLINICAL DECISION SUPPORT IS JUST THAT. IT'S DEVELOPING THIS INTERACTIVE ALGORITHM THAT BASED ON WHAT THE PATIENT IN FRONT OF YOU HAS, CAN THAT BE PORTRAYED IN THE ALGORITHM SO THERE IS EVIDENCE BASED ON THE SOCIAL, PHYSICAL AND PAIN ASSESSMENT AND DISEASE PROCESS IN THE ALGORITHM CAN THAT BE INFORMATIVE IN HELPING THE PROVIDERS, THE PROVIDER TEAMS, TO PROVIDE EVIDENCE-BASED THERAPEUTIC OR PREVENTION. IT'S A VERY SOPHISTICATED MODELING AND ALGORITHMS THAT ARE BEHIND THE SCENES IN ALL OF THESE CLINICAL DECISION SUPPORTS, BUT AS YOU SAID THEY ARE ONLY AS GOOD AS THE EVIDENCE IS. THAT'S WHERE WE'RE AT RIGHT NOW IN DECIDING WHAT THE EVIDENCE IS AND HOW CAN WE GENERATE THE ALGORITHMS. >> THERE'S A NUMBER OF PCORI GRANTS GOING RIGHT NOW ON THE DIFFERENT ASPECTS OF TREATING PAIN, WHETHER IT'S GOAL SETTING OR TAPERING AND WHAT ELSE THEY ARE DOING, ONE IS ON RELAXATION. HAVE YOU LOOKED AT THE PCORI GRANT? I CAN SEND YOU A LIST OF SOME I'M AWARE OF. >> IF YOU SEND THE LIST THAT'S GREAT. WE CHARGED MITER TO LOOK AT PCORI, THEY ARE IN THE EARLY STAGES. THEY WILL BE LOOKING AT PCORI RESULTS AND INCORPORATING THOSE. IF YOU HAVE SOME YOU KNOW, SEND THEM TO ME AND I WILL MAKE SURE THAT THEY ARE AWARE OF THOSE. THAT'S VERY HELPFUL. ANYBODY ELSE TOO, WHATEVER YOU HAVE, I KNOW TRIPP SENT ME A LOT OF STUFF FROM V.A. AND DoD WHICH I'VE ALREADY PASSED ON TO THEM. IN FACT, THAT WAS PART OF THE SELLING POINT WHEN I PITCHED THIS TO HHS WAS SOME OF THE WORK THAT WAS ALREADY DONE. BECAUSE A CDS IS ONLY AS GOOD AS WHAT'S DONE. IT'S NOT ABOUT GENERATING EVIDENCE. IT'S ABOUT TAKING EVIDENCE AND TRYING TO MAKE IT INTO A DECISION SUPPORT. OTHER QUESTIONS? AND I KNOW, CHAD, YOU KNOW THE CDC WITH THE OPIOID PRESCRIBING GUIDELINES IS ALREADY WORKING ON CDS. AND WE'RE PARTNERING WITH THEM BECAUSE THE 12 RECOMMENDATIONS IN THAT, SOME OF THEM ARE ALREADY UNDERGOING CDS SO WE JUST HAD A CALL WITH THE CDS TEAM TO TALK ABOUT WHICH ONES ARE THEY WORKING ON AND PERHAPS SOME OF THE WORK THAT WE CAN DO IS WORK ON THE 12 RECOMMENDATIONS THAT ARE NOT BEING PUT INTO CDS. I TRIED TO GET ALL 12 OF THOSE INCORPORATED. >> THANKS. >> THANKS A LOT, RC. NOW TRIPP. >> THANK YOU. I'M AWARE I'M THE ONLY THING BETWEEN YOU AND LUNCH. >> WE DON'T HAVE TO GO THROUGH SECURITY FOR LUNCH. WE'LL BE OKAY. [LAUGHTER] >> I'M CHIP BUCKENMAIER, REPRESENTING THE DEPARTMENT OF DEFENSE. (INAUDIBLE) DEVELOPING A CURRICULUM RECOGNIZING V.A. EMPLOYEES -- (INAUDIBLE) (OFF MICROPHONE) -- BY TRAINING DECIDED TWO HOURS FOR EVERY PRESCRIBER OF OPIATES IN OUR FEDERAL SYSTEM. THIS CURRICULUM IS USED TO ACCOMPLISH THAT. STRANGELY ENOUGH, THE PRESSURE OF WAR THAT WAS THE IMPETUS FOR THIS EFFORT IS SOMEWHAT BEEN RELIEVED AND IN A SITUATION RIGHT NOW WHERE LEADERSHIP -- (INAUDIBLE) THE UNITED STATES GOVERNMENT OR THE UNIVERSITY. THEY LIKE IT WHEN I DISTANCE MYSELF FROM THOSE SITUATIONS. I'M ALWAYS AFRAID OF THESE MICROPHONES. SO YOU'LL NOTE THAT WE'RE A LARGE ORGANIZATION, 9.6 MILLION HEALTH CARE BENEFICIARIES IN THE DoD. AND THE V.A. SLIGHTLY LESS. LARGE BUDGETS. LOTS OF DIFFERENT FACILITIES. LOTS OF FACILITIES NOT JUST THE UNITED STATES BUT WORLDWIDE. WE WANTED -- WHAT I WAS DISCUSSING BEFORE THOUGH IS WE'RE IN A SITUATION RIGHT NOW IN THE DoD WHERE I'M HAVING PROBLEMS WITH MY OWN LEADERSHIP RIGHT NOW EXPRESSING THAT WE EVEN HAVE AN OPIOID ISSUE. OF COURSE IF YOU'RE A SERVICE MEMBER AND HAVE YOU AN OPIOID ISSUE, YOU'RE NO LONGER A SERVICE MEMBER. SO NO PROBLEM. I THINK FOR THE VAST MAJORITY OF MY COLLEAGUES, THAT'S NOT THE WAY THE THINKING IS GOING, BUT IN AN ERA OF SO MANY COMPETING ISSUES WHICH I'M HEARING DESCRIBED IN THIS ROOM RIGHT NOW IT CONTINUES TO BE A CHALLENGE THAT THERE'S EVEN A PROBLEM. WHICH IS SORT OF FASCINATING WITH THE NEWS STORIES ON A DAILY BASIS. I'M CONVINCED THERE'S A CULTURAL CHANGE THAT NEEDS TO HAPPEN, NOT JUST IN OUR PROVIDERS BUT ALSO IN OUR PATIENTS. AND THAT THE ROOT OF THAT IS EDUCATION. IT'S INTERESTING IT WAS MENTIONED ABOUT THE DEANS. THEY ACTUALLY HAD THEIR NATIONAL MEETING LAST WEEK. DEAN KELLERMAN, MY UNIFORMED SERVICES DEAN WAS AT THE MEETING AND PRESENTED THIS SLIDE I'M SHOWING YOU RIGHT NOW. AT THE END OF THE TIME IT'S NOT THAT THE DEANS AREN'T INTERESTED BECAUSE HE WAS SWAMPED WITH REQUESTS ABOUT THIS INFORMATION, PARTICULARLY SINCE THIS IS ALREADY PAID FOR BY YOU AS A TAXPAYER AND IS AVAILABLE, BUT BECAUSE I DO THINK THERE'S REAL INTEREST IN TRYING TO ADJUST CURRICULUM. THE JPEP GOALS, DEVELOPED A CURRICULUM FOR DoD AND V.A., COMMON LANGUAGE, IMPROVING TRANSITION OF SOLDIERS, I'M AN ARMY GUY, I MEAN SERVICE MEMBERS, FROM OUR SYSTEM INTO THE V.A. AND ACTUALLY TRANSITIONING ALSO TO CIVILIAN MEDICINE. ONLY 50% OF OUR SERVICE MEMBERS ACTUALLY GO TO THE V.A. THAT MEANS THE OTHER 50% ARE GOING OUT ON THE ECONOMY. IN THE STREAMLINED PROCESS FOR NEW AND EMERGING IDEAS, ONE OF THE CHALLENGING ISSUES, THIS PROGRAM, IT'S DONE, ENDED IN AUGUST. WE'RE STRUGGLING NOW FOR ANY FUNDING WHATSOEVER TO KEEP THIS ALIVE, AND SUSTAINED. RIGHT NOW WE DO NOT HAVE THAT FUNDING. I BELIEVE THIS WILL PROBABLY BEGIN TO OF DEGRADING ABOUT THIS TIME NEXT YEAR. IT INCLUDES 31 MODULES EACH DELIVERED IN 30 MINUTES, JUST-IN-TIME INFORMATION. IT FOCUSES ON RED FLAGS, HOW TO TREAT, WHAT QUESTIONS TO ASK, WHEN TO REFER, AND THOSE AREAS WHERE EXAMINATION IS IMPORTANT, SPECIFIC JOINTS, SHOULDERS, KNEE EXAMS, ANKLE EXAMS, THERE ARE VIDEOS TO KIND OF TAKE THE PROVIDER THROUGH THAT. SO IF IT'S BEEN A LONG TIME SINCE YOU'VE DEALT WITH SHOULDER PAIN, YOU CAN GO INTO THIS CURRICULUM, GET THE INFORMATION YOU NEED, AGAIN JUST IN TIME, LOOK AT THE VIDEO, AND ANSWER THOSE QUESTIONS. IT'S NOT NECESSARILY DESIGNED TO BE DIGESTED ALL AT ONCE. OBVIOUSLY, 31 MODULES IS A LOT OF MATERIAL. IT WAS DESIGNED IN THESE PIECES SO THAT VARIOUS ORGANIZATIONS COULD CUT IT UP AND USE IT AS THEY DESIRED FOR THEIR NEEDS. AND THEN THERE'S THESE VIDEO ADJUNCTS WHERE THE LAST THINGS WE DEVELOPED, THE V.A. IS CONTINUING SOME OF THIS WORK ON A VARIETY OF DIFFERENT TOPICS. I CAN TELL YOU RIGHT NOW MANY HOSPITAL SYSTEMS WERE ALREADY RUNNING THESE ON THE CLOSED LOOP SYSTEMS, DESCRIBING A LOT OF OUR ISSUES. IF YOU'RE INTERESTED IN THIS MATERIAL, YOU CAN GO TO OUR ORGANIZATION, DVCIPM.ORG, AND GO AHEAD AND TAKE A LOOK AT IT. AGAIN, IT'S OPEN FOR USE. IT IS NOT ON ANY FEDERAL SYSTEM RIGHT NOW BECAUSE THAT CONTINUES TO BE A CHALLENGE. AND SO THE EXISTENCE IS ON OUR WEBSITE. I DO WANT TO MENTION THE DEFENSE AND VETERANS PAIN RATING SCALE. IF I HAD TO PICK ONE ACTIVITY WE'VE DEVELOPED THAT SUMS UP WHAT I THINK HAS TO HAPPEN, IT WOULD BE THE DEFENSE AND VETERANS PAIN RATINGS SCALE. THE PRIMARY FEATURE YOU NOTICE IS THIS FUNCTIONAL LANGUAGE. SO WE'RE GETTING AWAY FROM INTENSITY. I THINK 0-10 SCALE WHICH MUCH OF THE RESEARCH OUT THERE NOW HAS DONE US A REAL DISSERVICE. I'M AN ANESTHESIOLOGIST BY TRAINING. IF MY GOAL IS TO GET TO YOU ZERO PAIN, I GUARANTEE-DAMN-TE, I'LL GET YOUR PAIN TO ZERO. YOU MAY BE ON THE CARPET BLOWING SPIT PUBLISHES. IF INTENSITY IS OUR MEASURE, OPIOIDS ARE THE BEST THING. THAT'S WHAT WE'VE BEEN DOING TO OURSELVES AND OUR PATIENTS. SO WE NEED TO CHANGE THE FRAMEWORK BY WHICH WE'RE ASSESSING PAIN. AND RECOGNIZING THIS IS A BIOPSYCHOSOCIAL PROBLEM AND IT'S REALLY ABOUT FUNCTION. BOTH PHYSICAL FUNCTION WITH AN EMOTIONAL COMPONENT. THE FLIP SIDE TO THIS CARD ACTUALLY TALKS ABOUT THE IMPACT OF PAIN ON GENERAL ACTIVITY, SLEEP, MOOD, AND STRESS. ONE OF THE INTERESTING THINGS THAT'S GOING ON RIGHT NOW THOUGH IS THAT WHILE I CAN'T GET THIS MOVING IN THE DoD, THE STATES ARE COMING TO US, THE FIRST STATE WAS WEST VIRGINIA, BECAUSE THEY ARE FRONT LINES OF THIS ISSUE AND THEY SEEM TO -- WE SEEM TO BE THE UGLY DATE AT THE DANCE WITH THE DoD RIGHT NOW, BUT WITH WEST VIRGINIA THEY SEEM TO SEE THE BEAUTY IN THESE TOOLS. WE HAVE NO PROBLEM WITH HOSPITAL SYSTEMS GOING AHEAD AND TAKING THESE TOOLS AND MAKING THEM THEIR OWN. AND WEST VIRGINIA HAS DONE THAT. WE'RE ACTUALLY HAVING A MEETING NEXT WEEK WITH THE STATE OF VIRGINIA WHICH IS INTERESTING IN JOINING THIS COLLABORATION AND WE'RE GOING TO PROBABLY CONTINUE THIS EFFORT. WE FAILED ENOUGH IN THE DoD RIGHT NOW THAT WE FIGURE THAT SINCE WE'RE A REFLECTION OF CIVILIAN -- I'LL BE TERMINATED IN JUST A SECOND. IF WE'RE SUCCESSFUL WITH STATES WE'LL PENETRATE THE DoD THROUGH THE BACK DOOR ANYWAY. IT SADDENS ME THAT'S THE FOCUS WE'RE TAKING RIGHT NOW BUT I THINK WE'RE SORT OF A MICROCOSM OF THE CHALLENGES THIS GROUP HAS BEEN DEALING WITH ON A NATIONAL LEVEL. AND SO MISERY LOVES COMPANY. BUT I THINK YOU'RE GOING TO HEAR MORE ABOUT THIS COLLABORATION, PARTICULARLY AS OTHER STATES JOIN THAT ARE IN THE FRONT LINES OF THIS ISSUE. BUT THESE MATERIALS ARE AVAILABLE. THEY ARE YOURS. AND YOU'RE CERTAINLY FREE TO LEVERAGE THEM. THANK YOU. I'D BE HAPPY TO TAKE ANY QUESTIONS. ANY QUESTIONS? >> QUESTIONS FOR TRIPP? >> SO, YEAH, I GUESS I'M JUST TRYING TO UNDERSTAND THE POLITICS AS BEST I CAN. >> IF YOU DO, PLEASE LET ME KNOW. >> IN TERMS OF IMPLEMENTATION, THROUGH WHAT ARE THE DIFFERENCE STATES? YOU HAVE USES, OF COURSE, -- ACROSS THE STREET, THE MEDICAL SCHOOL. >> THAT'S OUR EDUCATIONAL -- THE ONLY MILITARY MEDICAL SCHOOL. >> IS THAT -- IS THERE TROUBLE GETTING INTO THE MEDICAL SCHOOL? >> GETTING INTO THE MEDICAL SCHOOL IS NOT A PROBLEM. SO WE'RE ACTUALLY -- WE'VE PENETRATED THE JPEP CURRICULUM INTO THAT FOR THE UNIVERSITY BUT THESE PROVIDERS ARE ON THEIR WAY, WE'RE NOT GOING TO BE SEEING THEM IN LEADERSHIP POSITIONS FOR AT LEAST FIVE TO TEN YEARS. AND AS WAS MENTIONED, WE HAVE A REAL CHALLENGE RIGHT NOW TO GET THIS INFORMATION TO THOSE FOLKS THAT ARE WRITING PRESCRIPTIONS TODAY. >> ARE THERE ACTUAL PAIN TREATMENT CENTERS WITHIN THE MILITARY SYSTEM? >> THERE ARE INTEGRATIVE HEALTH CARE SYSTEMS THAT CAME OUT OF THE PAIN MANAGEMENT TASK FORCE. BUT THE FUNDING FOR THOSE IS STARTING TO EVAPORATE. AND SO THE INTEGRATIVE HEALTH COMPONENTS, IT'S STILL A MIX THROUGHOUT THE SYSTEM BECAUSE THERE'S NO STANDARDIZED POLICY. WE HAVE THE SAME CHALLENGES, AND WE'RE IN SOME RESPECTS VICTIMS OF WHAT'S GOING ON IN CIVILIAN MEDICINE RIGHT NOW BECAUSE THAT'S WHERE WE DRAW OUR STANDARDS. AND SO I'M THRILLED THAT WE'RE TRYING TO MOVE DOWN THESE AVENUES. WE'VE HAD A LOT OF DISCUSSION WITH SOME OF THE OTHER FOLKS FROM THE FDA AND CDC ABOUT BEING PRE-SCRIPT ISSUE OFIVE. PRESCRIPTIVE. BEING IN THE MILITARY 26 YEARS I DON'T SEE A PROBLEM TELLING PEOPLE WHAT TO DO. I DON'T SEE A PROBLEM WITH FOLKS TRYING TO GET A LICENSE TO PRESCRIBE IN THE FIRST PLACE AND MAKE A DECISION WHAT THAT SHOULD BE. I IMAGINE THERE'S LOTS OF FOLKS OUT THERE THAT HAVE VEHEMENTLY DISAGREED WITH ME AT VARIOUS MEETINGS AND PROBABLY FEEL THE SAME WAY NOW BUT WHEN WE'RE FACING THE LARGEST EPIDEMIC IN THE HISTORY OF THIS COUNTRY IT SEEMS DRASTIC MEASURES ARE AT HAND AND FORCING PEOPLE TO GO THROUGH SOME EDUCATION, EVEN IF THEY ARE A PAIN DOC LIKE MYSELF, SEEMS A SMALL PRICE TO PAY TO GET EVERYBODY ON THE SAME LEVEL PLAYING FIELD ON HOW THESE MEDICATIONS SHOULD BE USED, WHEN THEY SHOULD NOT BE USED AND HOW OTHER COMPLEMENTARY TREATMENT PRACTICES ARE AVAILABLE AND SHOULD BE INTEGRATED INTO THEIR CARE. AGAIN, I'M AN ARMY DOCTOR. I'M NOT AGAINST OPIOIDS. I WOULD HATE TO DEPLOY WITHOUT THEM. THEY HAVE THEIR PLACE. JUST LIKE THE REST OF THE COUNTRY, MORPHINE HAS BEEN OUR HAMMER AND WE'VE BEAT EVERY PATIENT LIKE THEY ARE A NAIL. AND NOW WE'RE SUFFERING THE SAME CONSEQUENCES AS THE REST OF THE COUNTRY. IT'S JUST OUR CONSEQUENCES TEND TO GO OUT ON THE ECONOMY INTO THE V.A. THANK YOU. >> THANK YOU, TRIPP. APPRECIATE IT. >> OKAY. SO WE ARE AT OUR LUNCH POINT. THIS AFTERNOON, WE'RE GOING TO START WITH UPDATES TO THE NATIONAL PAIN STRATEGY, KEEPING YOU INFORMED. IT'S HARD TO CHECK IN ON THE WEBSITE EVERY TIME YOU WANT TO KNOW WHAT'S NEW AND WHAT'S BEEN ADDED. ALICIA RICHMOND SCOTT GRACIOUSLY AGREED TO GIVE US A LITTLE BIT OF AN UPDATE ON HOW THE IMPLEMENTATION PROCESS ITSELF IS GOING, AND AS A GROUP WE MET ALICIA BRIEFLY LAST YEAR AT THE FACE-TO-FACE MEETING. SHE'S BEEN WORKING WITH ME AND FORMERLY WITH TOM NOVOTNY AT THE OFFICE OF ASSISTANT SECRETARY, HE HAS RETIRED RECENTLY. SHE'S WORKING TO COORDINATE IMPLEMENTATION OF THE NATIONAL PAIN STRATEGYT HAS BEEN WITH THE OFFICE OF THE ASSISTANT SECRETARY FOR QUITE SOME TIME AND COORDINATED A NUMBER OF OTHER IMPORTANT PROJECTS. SO WE'RE GLAD TO HAVE HER TALENT ON THE NATIONAL PAIN STRATEGY. AND SO SHE'S GOING TO GIVE US A BRIEF OVERVIEW OF THE STATUS AND ACTIVITIES OF THE NATIONAL PAIN STRATEGY, PRIMARILY THE COMMITTEES AND THE WORK GROUPS. SO I'LL TURN IT OVER TO ALICIA. >> THANK YOU. SO I GUESS THANK YOU, LINDA. AND I GUESS THE FIRST THING THAT I WANTED TO JUST BE ABLE TO SHARE WITH THE GROUP, A NUMBER OF THE WORKING COMMITTEES, THE IMPLEMENTATION WORK GROUPS HAVE STARTED. AND THEY ARE CO-CHAIRED, THERE'S GENERALLY TWO AGENCIES THAT ARE CO-CHAIRING EACH OF THE SIX WORKING GROUPS. AND THE WORKING GROUPS ARE BROKEN DOWN BASED ON THE NATIONAL PAIN STRATEGY'S TOPICAL AREAS, POPULATION RESEARCH, SERVICE DELIVERY AND PAYMENT DISPARITIES, PREVENTION AND CARE, PROFESSIONAL EDUCATION AND TRAINING AND PUBLIC EDUCATION AND COMMUNICATION. SO FOR THE CHARGE FOR THE WORKING GROUPS IS TO REALLY FOCUS ON THE DELIVERABLES, SHORT, MEDIUM AND LONG TERM, FOR EACH OBJECTIVE FOR THE VARIOUS TOPICAL AREAS THAT I JUST HIGHLIGHTED. SO I GUESS THE ONE THING THAT I DID WANT TO BE ABLE TO HIGHLIGHT FOR THE GROUP IS THAT AS THESE WORKING GROUPS ARE FORMING AND CONVENING AND KIND OF TALKING ABOUT WHERE WE ARE, WE HAVE AN IDEA OF SOME OF THE ACTIVITIES THAT ARE GOING ON IN THE PRIVATE SECTOR -- IN THE PUBLIC SECTOR, AND PRIVATE SECTOR AS WELL, BUT WE WOULD LIKE TO ALSO, IF THERE ARE KEY THINGS THAT YOU FEEL LIKE YOU WANT TO HIGHLIGHT FOR US, PLEASE LET ME KNOW, AS WELL AS LINDA, BECAUSE WE'RE GOING TO BE INCLUDING EXTERNAL STAKEHOLDERS IN PARTS OF THE WORKING GROUP AS WE MOVE FORWARD WITH THIS VENTURE. SO THAT'S THE ONE THING I WANTED TO KIND OF SHARE. AND THEN THE NEXT THING IS THAT WE'LL DO A CALL FOR CURRENT ACTIVITIES THROUGH HHS, AS WELL AS WE'LL ALSO CONNECT WITH THE V.A. AND THE DoD TO SEE IF THERE ARE ANY NEW ACTIVITIES THAT ALIGN WITH THE NATIONAL PAIN STRATEGY THAT'S COMING UP PROBABLY THAT CALL WILL COME OUT SOME TIME IN NOVEMBER. AND THEN WE'RE ALSO AT THE BEGINNING OF SOMETIME NEXT YEAR KIND OF TRYING TO STRATEGIZE ON THE BEST TIMING BUT WE WILL ALSO HAVE ANOTHE LISTENING SESSION. SO WE HAD ONE LAST YEAR, EXCUSE ME, I'M ALREADY IN NEXT YEAR. WE HAD ONE THIS YEAR IN MAY, AND SO WE'RE FORECASTING WE WANT TO BE ABLE TO PLAN FOR ANOTHER ONE TO TAKE PLACE SOMETIME EARLY NEXT YEAR, EARLY MEANING NOT NECESSARILY JANUARY BUT FEBRUARY OR MARCH. AND KIND OF THINKING ABOUT BEING ABLE TO POTENTIALLY SHOWCASE SOME NEW WORK THAT'S BEING -- THAT'S HAPPENING IN THIS SPACE, SIMILAR TO WHAT WE DID EARLIER THIS YEAR. OKAY. >> THANK YOU SO MUCH, ALICIA. ANY QUESTIONS FOR HER? SHE'S REALLY TAKING A BIG PIECE OF THE WORK NOW THAT TOM HAS LEFT THE OFFICE, AND SO WE REALLY APPRECIATE HER HELP. NO? OKAY, GREAT. SO SHE WILL BE IN TOUCH, AND I'LL BE IN TOUCH FOR UPDATING ACTIVITIES IN THE LONG RUN. SO THERE IS A QUESTION? >> SO ALICIA, I WAS LOOKING AT THE WEBSITE. I DIDN'T SEE ANY RECENT UPDATES ON THIS LAST TIME THAT IT'S UPDATED. >> RIGHT. SO WE DID UPDATES UP THROUGH --& I WANT TO SAY PROBABLY JUNE OF 2016. SO THAT'S WHY WE'RE DOING ANOTHER CALL. WE WILL DO ANOTHER CALL FOR CURRENT ACTIVITIES AND NEW ACTIVITIES IN NOVEMBER. AND THEN WE'LL UPDATE IT AGAIN. >> OKAY. AS I UNDERSTAND BASICALLY THERE'S NOT BEEN NEW INITIATIVES OR NEW MONEY ALLOTTED TO START NEW THINGS. YOU'RE LOOKING FOR WHAT PEOPLE WITH ALREADY DOING THAT'S ALIGNING WITH IT? >> YES, BUT THEN THERE ARE ALSO WORK THAT OTHERS -- WITH THEIR EXISTING FUNDS, THERE MAY BE OTHER WORK THAT THEY ARE DOING THAT THEY HAVEN'T NECESSARILY IDENTIFIED EARLY ON. SO WE WANT TO MAKE SURE THAT WE'RE SENDING ANOTHER CALL OUT TO MAKE SURE THAT WE RECEIVED ALL INFORMATION FROM HHS, AS WELL AS THE OTHERS. V.A. AND DoD, TO SEE IF THERE'S ANY OTHER NEW INFORMATION THEY HAVEN'T ALREADY REPORTED, THAT THEY WANT TO ALSO NOW HIGHLIGHT >> SO WHAT DO WE HAVE TO DO TO GET MORE RESOURCES BEHIND THE NPS THAT WE MAKE PROGRESS INSTEAD OF LOOKING WHAT OTHER PEOPLE ARE DOING AND WHAT IS THE FISCAL YEAR 2018 BUDGET SHOWING US FOR ANY PROJECTS THAT MIGHT BE MINED, I'M WONDERING WHAT THE FUTURE IS BECAUSE RIGHT NOW WE DON'T SEEM LIKE WE'VE MADE A LOT OF PROGRESS. >> THAT'S A DIFFICULT QUESTION, AS ALWAYS. THERE WEREN'T RESOURCES TARGETED FOR THIS OR SET ASIDE FROM THE BEGINNING. I KNOW THAT'S BEEN A PROBLEM. SO AS ALICIA SAID, THE WORK GROUPS ARE UP AND RUNNING, AND ONE OF THE FIRST THINGS THAT THEY ARE TASKED TO DO PUT TOGETHER A WORK PLAN. ONCE THE PLAN IS IN PLACE IT MIGHT BE EASIER FOR THEM TO LOOK FOR RESOURCES AND APPROPRIATIONS COMING UP BUT THERE'S NOTHING SPECIFIC, THERE'S NO GLOBAL POT OF MONEY PUT ASIDE. I'M NOT EVEN SURE HOW WE WOULD KNOW HOW TO BUDGET FOR THAT BECAUSE IT'S SORT OF OBJECTIVE, OBJECTIVE DELIVERABLE, BY DELIVERABLE, I KNOW THERE ARE SOME ASKS IN THE WORK FOR SOME OF THE SMALLER PROJECTS BUT I THINK, YOU KNOW, THAT WILL EVOLVE OVER TIME. NOT A GOOD ANSWER TO A DIFFICULT QUESTION, AND MAYBE WALTER HAS SOME OTHER IDEAS ABOUT WHAT NEXT YEAR'S BUDGET MIGHT LOOK LIKE. YOU KNOW, NIH IS WORKING WITH SOME. OTHER AGENCIES TO LOOK FOR RESOURCES FOR OTHER PROJECTS THAT I THINK WILL COMPLEMENT, ALIGN WITH, AND MAYBE EVEN COVER SOME OF THE DELIVERABLES IN THE NPS BUT THAT'S A PRETTY VAGUE ANSWER AT THIS POINT. >> AND OVERALL APPROPRIATION, OVERALL MONEY FOR NIH? >> RIGHT. YEAH, I KNOW. I'M VERY ENCOURAGED BY ALL THE RESEARCH WORK THAT'S GOING ON, POSSIBILITIES FOR NIH BUT AS FOR THE OTHER AGENCIES, YOU KNOW, NO, IT DOESN'T LOOK LIKE A LOT'S HAPPENING OR BEING PUSHED TO HAPPEN IN OTHER FEDERAL AGENCIES. >> I HAVE A RELATED QUESTION. I'M CURIOUS WHETHER THERE ARE ANY MECHANISMS BY WHICH DIFFERET AGENCIES WITHIN HHS CAN BE BROUGHT TOGETHER TO IDENTIFY COMMON THEME, COMMON RESOURCE, YOU KNOW, TO BEGIN TO CREATE SUCH RESOURCES OVER TIME. AND IF THERE'S A MECHANISM AND A PROCESS BY WHICH THAT CAN OCCUR. >> SO THAT COULD BE DONE BY THE WORKING GROUPS, AND THEIR WORK PLANS. A SPECIFIC FUNDING MECHANISM, YOU KNOW, IT WOULD REALLY DEPEND ON WHAT THE DELIVERABLE WAS, IF I UNDERSTAND YOUR QUESTION. >> YEAH, JUST I MEAN IT'S JUST A LOT OF WORK HAS GONE INTO THE NATIONAL PAIN STRATEGY, AND IT'S NOW, YOU KNOW, UP A LEVEL ABOVE US, AND SO THE QUESTION IS HOW DO WE BEGIN TO IMPLEMENT SOME OF THIS AND OBVIOUSLY IT REQUIRES RESOURCES AND YES, WORKING PLAN, BUT WILL THOSE WORKING PLANS TRANSLATE INTO A PROCESS BY WHICH DIFFERENT AGENCIES CAN COME TOGETHER TO FUND THE WORKING PLAN. SO I GUESS I'M PERSONALLY NOT CLEAR HOW THE WORKING PLAN GETS TRANSLATED INTO SOMETHING WHICH IS A TANGIBLE. >> SO I WOULD JUST SAY THAT FOR -- I THINK, AGAIN, IT DEPENDS ON THE DELIVERABLE, BUT FOR SOME OF THE ACTIVITIES THE WORKING GROUPS ARE REALLY TALKING ABOUT HOW DO WE -- HOW ARE WE ABLE TO BEST FULFILL THIS SHORT-TERM DELIVERABLE, AND IF IT MEANS BEING ABLE TO CONSOLIDATE RESOURCES, THEN THAT'S SOMETHING THAT WE'RE STARTING TO KIND OF TALK ABOUT. BUT THE OTHER THING IS IF THERE ARE OTHER EXTERNAL PARTNERS THAT WE NEED TO BRING IN, THAT'S THE OTHER QUESTION THAT WE'RE ASKING. WHO ELSE SHOULD BE AT THE TABLE FOR CERTAIN OBJECTIVES AND DELIVERABLES? AND TO THE EXTENT POSSIBLE, TO MAKE SURE THAT WE'RE ALL ALIGNED AND MOVING FORWARD IN THE SAME WAY. SO I KNOW THAT THAT DOESN'T, AGAIN, ANSWER IN TERMS OF NEW MONEY, IN THIS EFFORT, BUT JUST BEING ABLE TO BE MINDFUL OF HOW DO WE -- THE FEDERAL GOVERNMENT CAN'T DO IT ALL SO HOW DO WE& WORK TOGETHER TO BE ABLE TO GET IT DONE IS REALLY THE SECOND PART OF THAT, THAT QUESTION. >> ALICIA, HAVE PAYERS BEEN MENTIONED AS ANOTHER PARTY TO BRING TO THE TABLE? >> SO THAT'S SOMETHING THAT IN TERMS OF THE WORKING GROUPS, THAT'S SOMETHING THAT NEEDS TO BE DISCUSSED. IT HASN'T FULLY BEEN EXPLORED. SO THANK YOU FOR RAISING IT. AND THEN DEFINITELY AS LINDA HAS SAID, YOU KNOW, IN TERMS OF THE WORKING GROUPS, I'M TRYING TO BE ON ALL OF THEM SO THAT AS THESE POINTS ARE BEING MADE THAT I CAN BRING IT BACK SO ALL OF THEM CAN HEAR THE SAME MESSAGE AND BE ABLE TO CONSIDER IT. >> COMMENT? >> YEAH. THIS IS RIC RICCIARDI FROM AHRQ. I WANT TO MAKE SURE YOU'RE ALL AWARE AHRQ IS RESPONSIBLE ALONG WITH THE ASSISTANT SECRETARY TO DO IMPLEMENTATION WORK. SO IT'S NOT HELPFUL IN TERMS OF RESEARCH GENERATION, NEW KNOWLEDGE GENERATION. WHERE IT COULD BE HELPFUL, I'M LOOKING AT THE AHRQ WEBSITE ANY ORGANIZATION THAT HAS A BEST PRACTICE THAT'S SUPPORTED BY EVIDENCE, WHETHER IT'S PCORI EVIDENCE OR NIH EVIDENCE, OR PRIVATE FOUNDATION EVIDENCE, COULD MAKE A NOMINATION THROUGH THE WEBSITE FOR THAT BEST PRACTICE TO BE IMPLEMENTED. NOW, THERE'S A TEAM AT AHRQ THAT LOOKS AT THE EVIDENCE AND WEIGHS THE EVIDENCE. IF IT MEETS THAT GOAL THEN IT WOULD LOOK AT FEASIBILITY STRATEGY OF DOING IMPLEMENTATION. AFTER LOOKING AT FEASIBILITY STRATEGY IF IT PASSES THE TEST FOR BOTH OF THOSE IT WILL BE PUT ON THE LIST FOR A POTENTIAL PILOT STUDIES OR PERHAPS EVEN A FULL SCALE IMPLEMENTATION. FROM MONIES THAT ARE PROVIDED THROUGH THE TRUST FUND. AS LONG AS THAT MONEY KEEPS COMING. SO I JUST PUT THAT OUT THERE. IT'S NOT REALLY TO MEET THE BASIC SCIENCE INITIATIVES OR NEW KNOWLEDGE GENERATION. IT'S MORE ABOUT IMPLEMENTING WORK THAT'S ALREADY BEEN DONE. THAT HAS PROMISING -- YOU KNOW, IS PROMISING TO THE PRACTICE COMMUNITY OR HEALTH SYSTEMS TO PROVIDE -- >> THAT'S AN IMPORTANT POINT. HE'S A CO-CHAIR OF ONE OF THE WORK GROUPS SO THOSE ARE THE KIND OF IDEAS THAT COME UP THROUGH THE WORK GROUP SYSTEMS THAT THERE ARE RESOURCES THAT CAN BE TARGETED BUT THERE IS NO GLOBAL POT OF MONEY. I DON'T THINK THERE WILL BE. >> WELL, I'M ALWAYS MORE OF AN OPTIMIST THAN LINDA. >> SOME DAYS I'M A REALIST. >> IN THIS BUSINESS I THINK BEING PREPARED IS THE FIRST STEP, AND THEN YOU HAVE TO SEE WHAT HAPPENS. SO I THINK THE GOOD NEWS IS THAT, YOU KNOW, WITH ALL THE WORK THAT FOLKS AROUND THE TABLE AND THEIR COLLEAGUES HAVE DONE WITH THE NATIONAL PAIN STRATEGY AND RESEARCH STRATEGY, EVERYTHING IS SET OUT, WHAT WE NEED TO DO AS A COUNTRY IN THESE TWO AREAS, AND THE QUESTION IS WOULD MONEY BECOME AVAILABLE. AND I MEAN I'M NOT -- I THINK, YOU KNOW, WITH THE OPIOID CRISIS BEING RIGHT IN FRONT OF US, I THINK THERE COULD BE -- COULD CERTAINLY BE AN EMPHASIS TO TRY AND DO SOMETHING THERE THAT IS GOING TO TAKE ADVANTAGE OF ALL THE WORK THAT'S BEEN DONE AND HOW BEST TO MANAGE PAIN AND LIMIT ADDICTION. I THINK HAVING ALL THIS READY, I MEAN, IT'S POSSIBLE THAT WE COULD STRIKE OUT WITH FUNDING. I THINK WE JUST HAVE TO WAIT AND SEE. CERTAINLY AS FEDERAL AGENCY WE CAN'T LOBBY FOR FUNDING. THAT'S AGAINST -- WE GO JAIL FOR THAT. SO BUT I THINK WE CERTAINLY ARE PREPARED, FOR SURE, SHOULD FUNDING BECOME AVAILABLE, WHICH IS NOT A TRIVIAL THING TO DO, FOR SURE. SO I THINK WE'RE IN GOOD SHAPE THERE AND WE'LL KEEP OUR FINGERS CROSSED. >> I THINK IN THE OTHER SIDE OF THE COIN, WITH ALL THE WORK THAT'S BEEN DONE TO MAKE THE MOST OF IT, EVEN WITHOUT FUNDS, I THINK THERE ARE LOTS OF PEOPLE WHO WOULD SUBSCRIBE TO THE MISSION THAT'S IN THE NPS AND FEDERAL PAGE RESEARCH STRATEGY. SO AS A GROUP WE COULD THINK ABOUT CONVENING FOLKS AND MAKING SURE THAT PEOPLE WHO ARE IN THE POSITION WHERE THEY HAVE TO DO SOMETHING, MEDICAL SCHOOL LEVEL, HOSPITAL LEVEL, THAT THEY ARE AWARE OF ALL THE GROUND WORK THAT'S BEEN DONE ALREADY. SO I THINK WE SHOULD CONSIDER IN THE FUTURE MEETINGS KEEPING THIS ALIVE AND SEEING WHO WE CAN REACH OUT TO WITH OUR CONVENING POWER. >> CAN I JUST ADD SOMETHING? PART OF THE NATIONAL PAIN STRATEGY WAS TO CHANGE THE CULTURE HOW PEOPLE THINK ABOUT PAIN. A LOT OF WAYS THAT HAS TO BE DONE IN THE PUBLIC ARENA, NOT SO MUCH IN THESE MEETINGS HERE IN THE SCIENTIFIC COMMUNITY. PUBLIC ARENA IS GENERALLY FRIENDLY TO ANYTHING THAT'S NEWS. NEWS FOR THEM IS SOMETHING THEY DIDN'T KNOW BEFORE, EVEN IF IT'S OLD STUFF TO US. SO I THINK THERE ARE ALWAYS OPPORTUNITIES TO HAVE SOME NEW HOOK, EVENT, DATA LIKE THIS TO GET THEM TO COME TO THE MEETING AND SAY LOOK, THINGS ARE HAPPENING HERE, BUILD UP MOMENTUM. THAT MAY HAVE EFFECT ON THOSE MAKING DECISIONS. >> ALL RIGHT. SO WE'RE GOING TO MOVE TO SOME OF THE SPECIFIC PROJECT UPDATES FROM NATIONAL PAIN STRATEGY. WE HAVE A FEW TODAY. AND NEXT UP IS CATHY UNDERWOOD. I THINK SHE'S ALREADY READY TO GO. >> I'VE BEEN READY TO GO BECAUSE I THOUGHT WE WERE ALMOST FINISHED. >> ALMOST ALMOST FINISHED. CATHY BRIEFLY TALKED LAST YEAR ABOUT APS PFIZER GRANTS THAT WERE DIRECTLY TARGETED TO NPS OBJECTIVES BUT AT THAT POINT THINGS WERE STILL SOMEWHAT CONFIDENTIAL. SO SHE IS GOING TO GIVE US MORE DETAIL ON HOW THEY ARE MOVING FORWARD NOW. THANKS, CATHY. >> NO PROBLEM. THIS JUST KIND OF GIVES YOU THE TIMELINE OF WHAT WE WERE WORKING WITH. WE ACTUALLY STARTED THIS IN MAY OF 2015. AND IT REALLY -- WE REALLY BEGAN OUR WORK IN THE BEGINNING OF 2016, AND THEN THE NATIONAL PAIN STRATEGY WAS RELEASED. BUT THE IMPETUS BEHIND THIS, BEHIND WHAT APS WAS TRYING TO DO IS THAT THERE WERE MANY PEOPLE, MANY MEMBERS OF APS THAT WERE INVOLVED IN THE CREATION OF BOTH THE IOM REPORT AND THE NATIONAL PAIN STRATEGY, AND IT HAS -- IT IS ONE OF OUR STRATEGIC GOALS. SO IT'S VERY MUCH ON OUR RADAR AND WANTING TO MAKE SURE THAT WE KNOW THAT SOMETHING'S HAPPENING. AND SO WE FORMED A STEERING COMMITTEE, MOST OF THESE FOLKS ARE PROBABLY FAMILIAR TO YOU BUT THEY DID AN AWFUL LOT OF WORK. AND WE RELEASED THE RFP IN APRIL OF 2016. ULTIMATELY, AFTER A LOT OF I THINK LIKE 100 LETTERS OF INTENT AND A LOT OF WORK GOING BACK AND FORTH TRYING TO REVIEW WHAT WOULD BE APPROPRIATE, THREE PROPOSALS WERE SELECTED. AND I THINK LAST YEAR I DIDN'T -- I'M NOT SURE I EVEN KNOW ALL THAT MUCH. BUT THEY ARE ALL NON-PHARMACOLOGICAL PROJECTS. THEY SPAN FROM YOUTH TO GERIATRIC PERSONS WITH CHRONIC PAIN. EACH TWO YEARS IN LENGTH. AND COINCIDENTALLY THEY ARE GEOGRAPHICALLY DISPERSED, WHICH IS KIND OF NICE. THE FIRST IS A WEB-BASED SELF-MANAGEMENT PROGRAM FOR ADOLESCENTS BEING LED BY TANYA PALERMO AT SEATTLE CHILDREN'S, DISSEMINATING A MOBILE INTERVENTION TO ADOLESCENTS WITH CHRONIC PAIN, NOT SOMETHING THEY INTEND TO MAKE PROPRIETARY AND SO WHAT THEY ARE TRYING TO DO IS SEE WHETHER OR NOT IT WORKS AND THEN MAKE IT AVAILABLE FOR FREE TO OTHER PAIN CLINICS THAT TREAT ADOLESCENTS, TRYING TO MAKE SURE THAT IT CAN BE ATTEND IN REAL WORLD SETTINGS. WE ASKED EACH APPLICANT TO IDENTIFY WHICH OBJECTIVES OF THE NATIONAL PAIN STRATEGY RECOMMENDATIONS THEY ADDRESSED. SO THESE ARE ON THE SLIDES. I'M NOT GOING TO GO OVER THEM. BUT THEY HAD STARTED WITH SOMETHING CALLED WEB MAP. AND IT WAS ORIGINALLY I THINK TONYA HAS BEEN WORKING ON IT A WHILE, IT'S A COMPUTER PROGRAM, AND THEY CREATED AN APP ULTIMATELY AVAILABLE ON IPHONE AND ANDROID, TYING IT IN EIGHT SPECIALTY CARE SITES, PAIN, G.I. FOR ADOLESCENTS, LEARNING HOW TO TO SUSTAIN THE INTERVENTION IN THOSE CLINICAL SETTINGS. ULTIMATELY THEY HOPE TO IMPROVE ACCESS TO EVIDENCE-BASED PAIN SELF-MANAGEMENT FOR ALL YOUTH. AND SO ONE THING I DIDN'T SAY, AND I DON'T KNOW IF I HAVE A SLIDE AT THE END OR NOT, BUT THE GOAL IS TO HAVE A REPORT AT THE ANNUAL SCIENTIFIC MEETING OF THE AMERICAN PAIN SOCIETY IN SPRING OF 2019. SO WE HAVE HAD ONE MEETING WITH ALL OF THE AWARDEES, AND IT WAS FASCINATING TO LISTEN TO THEM TALK ABOUT THEIR WORK AND SHARE AND THEY FELT THERE WERE SOME OVERLAPS THEY COULD WORK ON TOGETHER. IT WAS VERY ENERGIZING, THAT WAS AT THE MAIN MEETING JUST THIS YEAR. SO THERE'S A LOT OF ENTHUSIASM AND CROSS-FERTILIZATION GOING ON. THE SECOND AWARD WAS TO KATHLEEN SOLUCA AND BARBARA RAKEEL AT THE UNIVERSITY OF IOWA. WHAT THEY ARE DOING IS TO USE A NON-PHARMACOLOGICAL TREATMENT FOR ADULTS WITH CHRONIC MUSCULOSKELETAL PAIN. SINCE I CAN'T SAY TENS WITHOUT STUMBLING OVER IT, WHAT THEY ARE DOING IS USING THE EPIC ELECTRONIC HEALTH RECORD TO CREATE STANDARDS AND ALGORITHMS TO BE ABLE TO PRESCRIBE TENS IN THE CASE OF CHRONIC MUSCULOSKELETAL PAIN. AND I THINK WHAT IS PROBABLY THE MOST ENERGIZING ABOUT THIS FOR ME IS THAT EPIC OBVIOUSLY IS IN HOSPITALS AND HEALTH CARE SYSTEMS NATIONWIDE, AND IF, YOU KNOW, -- AND I DREAM BIG, BUT IF THEY ARE SUCCESSFUL AT THIS, IT WOULD BE THE FIRST NON-PRESCRIPTION ALGORITHM THAT WOULD BE PUT INTO THE EPIC SYSTEM. AND ANYBODY THEN THAT HAS THE EPIC SYSTEM PERHAPS THEY WOULD BE ABLE TO ADOPT IT. IT IS INTENDED TO BE USED PRIMARILY FOR PRIMARY CARE PROVIDERS. AND EPIC IS PARTNERING WITH THEM. SO THEY HAVE OUR GRANT AND EPIC IS PARTNERING AS WELL. SO THAT I THINK IS A REALLY GOOD SIGN. THEY ARE GOING TO TRIAL IT IN THREE OUTPATIENT CLINICS AT THE UNIVERSITY OF IOWA HEALTH CARE SYSTEM. AND FOCUS ON FAMILY MEDICINE AND GENERAL INTERNAL MEDICINE. AND THEY ARE INCLUDING 48 PRESCRIBERS. AND THEN THEY ARE GOING TO EVALUATE THE EFFECT ON PRESCRIPTION FREQUENCY OF NON-PHARMACOLOGICAL AND PHARMACOLOGIC TREATMENTS TRYING TO COMPARE IF A PRESCRIPTION OR PRESCRIBER HAS ACCESS TO ALGORITHM TO PRESCRIBE TENS FOR MUSCULOSKELETAL PAIN THEY MIGHT NOT BE SO QUICK TO PRESCRIBE PHARMACOLOGICAL TREATMENT. IF ANYBODY SAW ME LIMP UP TO THE PODIUM, I AM WEARING A BRACE AND I HAVE P.T. TWICE A WEEK FOR THE NEXT TWO MONTHS. MY SURGEON HAS NO IDEA WHAT HAPPENS IN P.T. OR HOW I'M DOING. HE JUST SAYS SEND 'EM TO P.T. AND YOU'RE IN A BLACK HOLE. THE PHYSICAL THERAPISTS WRITE THEIR NOTES, REPORT BACK. YOU KNOW, THEY CHART. BUT THERE'S A DISCONNECT. AND SO THE HOPE IS THAT BY PUTTING IT INTO THE ELECTRONIC HEALTH RECORD THERE WOULD BE A CONNECTION BETWEEN WHAT THE PHYSICAL THERAPIST OR OCCUPATIONAL THERAPIST IS DOING AND WHAT THE PHYSICIAN SEES AS A RESULT OF THEIR PRESCRIPTION, WHICH I THINK IS INCREDIBLY EXCITING. THE THIRD GRANT, SO WE'VE DONE WEST, WE'VE DONE MIDWEST, AND NOW WE'RE ON THE EAST COAST, CARRIE REID AND DEMETRIUS KAOSIS ARE DOING A PERSONALIZED SELF MANAGEMENT PROGRAM FOR OLDER ADULTS WITH CHRONIC PAIN AND NEGATIVE EMOTIONS. BEHAVIORAL SIDE OF THINGS, AND THEY ARE PARTNERING WITH -- MAYBE IT'S ON MY NEXT SLIDE. AGAIN, THIS WAS AN APPLICATION OF SOMETHING THAT THEY HAD ALREADY DEVISED, AND THEY ARE TESTING THAT EFFICACY PATH, THEIR NAME FOR IT, PATH PAIN, VERSUS USUAL CARE FOCUSING ON ADULTS OVER 60 YEARS OLD WITH CHRONIC PAIN, AND NEGATIVE EMOTIONS, WITH WIDE RANGE OF COGNITIVE FUNCTIONING. WHICH, AGAIN, IS SOMETHING NEW AND DIFFERENT BECAUSE THEY RECOGNIZE THE FACT THAT'S AN IMPORTANT PIECE OF THE PAIN TREATMENT, ESPECIALLY IN OLDER ADULTS. AND THEY ARE LOOKING TO REDUCE PAIN INTENSITY AND PAIN-RELATED DISABILITY. THEY ARE -- THIS IS REALLY A LOT OF THE WORK. THEY ARE GOING TO MANUALIZE, WHAT THEY HAVE DONE IS BASICALLY CREATE A TEACHING MANUAL WITH AN 8-WEEK EMOTIONAL REGULATION SELF-MANAGEMENT PROGRAM FOR PRIMARY CARE PATIENTS. THE PATIENTS HAVE TO BRING THEIR CAREGIVER WITH THEM SO IT'S A PARTNERSHIP, AND THEY BOTH GO THROUGH THE PROGRAM, SO THAT THEY SUPPORT EACH OTHER SO THAT THE PATIENT ISN'T THE FOCAL POINT. IT'S BOTH THE PATIENT AND THE CAREGIVER. AND THEN THERE ARE BOTH GROUP AND INDIVIDUAL EDUCATIONAL SESSIONS. THEY HAVE ALSO MANUALIZED -- THAT'S FOR THE PEOPLE THAT ARE GOING THROUGH IT. THEY HAVE ALSO MANUALIZED IT FOR THE TREATMENT DELIVERED IN PRIMARY CARE. AND SO THEY HAVE AN EDUCATIONAL MANUAL CALLED TAKE CHARGE OF YOUR PAIN, AND THEY ARE WORKING THROUGH THIS ON A TRAIN-THE-TRAINER PROCESS TO REDUCE INTENSITY AND PAIN-RELATED DISABILITY. THEY ARE -- I DIDN'T PUT DOWN THE GROUP THAT THEY ARE COLLABORATING WITH BUT THEY HAVE 50,000 OLDER ADULTS AS THEIR COHORT, BECAUSE THEY ARE WORKING WITH THE -- ROGER, I CAN'T EVEN REMEMBER THE NAME OF IT BUT IT'S A GERIATRIC CENTER AT WEILL CORNELL. TRIPLE CENTER, THANK YOU. I THINK THERE'S A PERSON'S NAME ON IT TOO BUT THEY HAVE ACCESS TO 50,000 PEOPLE. AND I THINK THIS IS SOMETHING THAT THEY ARE VERY EXCITED ABOUT. ALL THREE OF THESE, NOT SO SURE ABOUT UNIVERSITY OF IOWA BUT TONYA AND CARRIE HAVE BEEN GIVEN A GRANT TO DO, INTERESTED IN MAKING IT AVAILABLE TO EVERYBODY. WHICH, AGAIN, IS EXACTLY WHAT APS WAS HOPING WE WOULD BE ABLE TO DO WITH PFIZER'S MONEY, AND OUR HOPES HAVE BEEN REALIZED. SO THE NEXT THING IS WE DID ALREADY CONVENE THEM. I TALKED ABOUT THAT. AND THEN WE WILL CONTINUE TO GET PROGRESS REPORTS FROM THEM. THERE IS A THOUGHT THAT WE'LL BRING THEM TOGETHER AGAIN MID-POINT, TO SEE HOW THEY ARE DOING AND MAKE SURE THEY ARE ENGAGED AND WORKING, IF IT'S APPROPRIATE, WITH ONE ANOTHER AND WE'LL BE PRESENTING THE OUTCOMES AT THE 2019 ANNUAL MEETING WHICH WILL PROBABLY BE IN THE SPRING OF THAT YEAR. SO DOES ANYBODY HAVE QUESTIONS? I'M GLAD I GOT TO GIVE YOU AN UPDATE. THANK YOU. >> CATHY, I'D LIKE TO MAKE A COMMENT THAT I THINK THAT THIS IS AN EXAMPLE OF, YOU KNOW, STAKEHOLDERS COMING FORWARD AND PROVIDING TECHNOLOGIES THAT WILL HELP NOT ONLY WITH PAIN MANAGEMENT BUT WITH THE OPIOID CRISIS. AND IT GOES BACK TO EARLIER DISCUSSION, WHERE THESE ARE REALLY INTERWOVEN EPIDEMICS, AND WHEN WE TALK ABOUT DEVOTING RESOURCES TO PAIN MANAGEMENT, WE'RE ALSO TALKING ABOUT I THINK DEVOTING RESOURCES TO THE OPIOID CRISIS. AND SO IT'S REALLY, YOU KNOW, THESE ARE TO THE POINT -- REALLY TRULY INTERWOVEN, AND SO I FIND IT DIFFICULT TO -- WE THINK ABOUT THE NATIONAL PAIN STRATEGY AND MOVING FORWARD WITH RESOURCE ALLOCATION, THAT WE NEED TO THINK ABOUT IT IN DUAL TERMS BECAUSE I THINK THERE'S HUGE PAYOFF FOR THE COUNTRY WHEN WE DO SO. >> OKAY. THANK YOU. >> JUST BEFORE YOU GO, COULD YOU BE ABLE TO SAY TO US, YOU KNOW, WHAT KIND OF RESOURCES HAVE BEEN GOING INTO THESE DIFFERENT GROUPS AND . >> WE STARTED -- I WAS COUNTING ON YOUR MEMORIES. WE STARTED WITH $2 MILLION GRANT FROM PFIZER AND WERE ABLE TO GIVE THE THREE PROGRAMS, $580, 000, TO $780, $780,000, A GOOD IMPLEMENTATION GRANT AS OPPOSED TO CREATING NEW DATA. >> THANK YOU, CATHY. >> DID YOU HAVE A QUESTION? >> I JUST HAD A QUICK QUESTION. THANK YOU. THESE ARE EXCITING. ARE SOME OF THESE LEADING TO BEST PRACTICES? >> YES. SO I THINK IT WAS YOU WHO SAID THAT THE WEBSITE WAS GOING -- >> IT WAS RIC. >> THAT'S RIGHT. THIS WAS SOMETHING THAT WOULD GO ON THE WEBSITE TO BE BEST PRACTICES OR TO HAVE REVIEW? >> IF YOU'RE LOOKING FOR NEW FUNDING, THAT WOULDN'T HELP BECAUSE THESE HAVE ALREADY BEEN FUNDED. NOW, IF THEY LOOK -- IF IN THE FUTURE THEY ARE GOING TO BE LOOKING TO FOR GRANTS, TONYA IS LOOKING FOR DISSEMINATION GRANT, MORE MONEY. WHAT APS WANTED TO DO WAS MAKE A FIRST STEP IPSC STEP, IT WAS ONE OF OUR STRATEGIC GOALS. >> THANK YOU. >> OKAY, GREAT. THANKS A LOT, CATHY. CHAD IS GOING TO TALK ABOUT HOW THE NATIONAL HEALTH INTERVIEW SURVEY DATA MINING IS COMING ALONG AND FOLLOW-UP STEPS TO THAT. >> HAPPY TO BE HERE FROM CDC TALKING ABOUT SOMETHING CLOSE TO OUR HEARTS DOWN THERE, THE NATIONAL HEALTH INTERVIEW SURVEY. A COUPLE THINGS I'LL BE TALKING ABOUT. ONE IS WHAT SOMEBODY SAID WAS MINING THE DATA ON PAIN. THE SECOND THING WILL BE ABOUT RESTRUCTURING. I'M JUST GIVE YOU BRIEF BACKGROUND BECAUSE THIS GOES BACK IN IPRCC HISTORY A BIT AND I'LL GET INTO THE TWO ISSUES WE'RE TALKING ABOUT HERE. THE BACKGROUND IS THAT IN OCTOBER 2012, FIVE YEARS AGO, ASSISTANT SECRETARY FOR HEALTH DR. COACH CHARGED WITH A NATIONAL PAIN STRATEGY CREATION, THE SECOND THING INCLUDE CHRONIC PAIN OBJECTIVES FOR HEALTHY PEOPLE 2020, NOT SOMETHING THAT PEOPLE HAD HEARD ABOUT BUT THAT WAS SOMETHING THAT HAPPENED. NATIONAL PAIN STRATEGY HAS HAPPENED SINCE THAT TIME. AND HEALTHY PEOPLE 2020 HAS MADE PROGRESS SINCE THAT TIME. SO HEALTHY PEOPLE 2020 FOR THOSE WHO ARE NOT FAMILIAR WITH IT ARE THE HEALTH OBJECTIVES FOR THE NATION, DEPARTMENT MUCH HEALTH AND HUMAN SERVICES CREATES. NOBLE GOALS TO ATTAIN HIGHER QUALITY LONGER LIVES, HEALTH EQUITY, BETTER ENVIRONMENTS AND PROMOTE QUALITY OF LIFE. TO BECOME AN OBJECTIVE FOR HEALTHY PEOPLE 2020, WE DID THIS OURSELVES, A VARIETY OF POTENTIAL OBJECTIVES. WE ENDED UP SETTLING ON A FEW OF THESE. THESE WE CREATED WITH A GROUP AGAIN WHO PUT A LOT OF WORK INTO DECIDING HOW SHOULD WE DEFINE PAIN IN THIS INSTANCE, AND THEN WHAT ARE THE OBJECTIVES WE SHOULD HAVE, AND THIS FEEDS INTO THE NATIONAL HEALTH INTERVIEW SURVEY I'LL TALK ABOUT IN A MINUTE. SO WE WERE LUCKY TO GET FOUR DEVELOPMENTAL OBJECTIVES AT THE TIME. DEVELOPMENTAL MEANS THESE WERE APPROVED AS VERY WORTHY OBJECTIVES BUT THERE BETTER BE DATA OR THEY WILL BE KICKED OUT. MAIN OBJECTIVES IS TO DECREASE PREVALENCE OF ADULTS HAVING HIGH IMPACT CHRONIC PAIN. HIGH IMPACT CHRONIC PAIN IS SOMETHING WE SPEND A LOT OF TIME THINKING ABOUT AND DEFINING FOR OUR OWN PURPOSES. YOU'LL HEAR ABOUT THAT IN A MINUTE. WE ALSO HAD THREE OTHER OBJECTIVES WE THOUGHT WERE IMPORTANT. ONE TO INCREASE PUBLIC AWARENESS AND KNOWLEDGE THAT I JUST TALKED ABOUT, INCREASE SELF-MANAGEMENT OF HIGH IMPACT CHRONIC PAIN AND REDUCE IMPACT ON FAMILY AND SIGNIFICANT OTHERS. SO WITH NINDS FUNDING WE WERE ABLE TO GET TWO QUESTIONS ADDED TO THE NATIONAL HEALTH INTERVIEW SURVEY FOR 2016 AND 2017. IT'S A NATIONALLY REPRESENTATIVE SURVEY OF THE CIVILIAN NON-INSTITUTIONALIZED POPULATION, STANDARD SURVEY TO USE WHEN YOU'RE MEASURING HEALTHY PEOPLE 2020 OBJECTIVES AND IT GIVES A GOOD IDEA WHAT'S GOING ON WITH THE POPULATION AS A WHOLE, SURVEY OF 35,000 PEOPLE EVERY YEAR. OUR PAIN QUESTIONS BOTH USED SIX-MONTH TIME HORIZON TO ASK HOW OFTEN DID YOU HAVE PAIN AND HOW OFTEN DID PAIN LIMIT YOUR WORK OR LIFE ACTIVITIES. YOU CAN SEE FROM THE BOLDING, OUR DEFINITION IS CHRONIC PAIN IF IT WAS ON MOST DAYS OR EVERY DAY, AND IT WAS LIMITING IF IT WAS LIMITING ON MOST DAYS OR EVERY DAY. THE CONCEPT TO CREATE CHRONIC AND NON-CHRONIC PAIN CATEGORIES, LOW IMPACT AND HIGH IMPACT PAIN CATEGORIES AND SEE HOW THOSE WOULD PERFORM. WE'VE BEEN WORKING WITH THE NATIONAL HEALTH INTERVIEW SURVEY STAFF SINCE THAT TIME AND THEY HAVE THEIR OWN INTERESTS IN ALL THIS. THEIR INTEREST IS TO SAY, OKAY, FINE, YOU HAVE YOUR DEFINITION OF HIGH IMPACT CHRONIC PAIN, I'M GOING TO LOOK FROM THE BEGINNING AGAIN AND SEE WHAT WE THINK ABOUT IT SO THERE'S BEEN A LOT OF METHODOLOGICAL EXPLORATION OF HOW PAIN MIGHT BE DESCRIBED IN THIS SURVEY. THEY LOOKED A LOT OF SOCIODEMOGRAPHIC CHARACTERISTICS TO SEE IF THEY PARALLEL WHAT IS KNOWN ALREADY AND LOOKED AT HEALTH OUTCOMES, SERIOUS PSYCHOLOGICAL DISTRESS, LIMITATIONS, WORK LIMITATIONS, HEALTH STATUS, BAD DAYS, SLEEP. AND THEY BASICALLY AGREED HIGH IMPACT CHRONIC PAIN SHOULD BE DEFINED THE WAY WE'VE DONE IT, WHICH IS GOOD NEWS. THAT'S A POSITIVE DEVELOPMENT THERE. WE ARE HAVING ONGOING DELIBERATIONS WITH THIS GROUP. WE WANT TO COMPLETE THE ANALYSIS OF THE 2016 DATA AND WE WANT TO DECIDE HOW TO PUBLISH THAT. AND NEXT YEAR WE WOULD BE ADDING THE 2017 DATA WHICH WILL GIVE US MORE STATISTICAL POWER TO LOOK AT MORE DETAIL WHAT'S HAPPENING THERE. I MENTIONED PUBLICATIONS AND ISSUES WE'RE DEALING WITH ON PUBLICATIONS IS HOW TO DO THIS, A COUPLE WAYS TO DO IT. THERE'S THE MMWR, CDC HOUSE JOURNAL MORBIDITY AND MORTALITY WEEKLY REPORT. YOU MAY HAVE HEARD OF THAT. THAT HAS ADVANTAGE OF SOMETHING THAT CAN COME OUT VERY QUICKLY AND IT'S REVIEWED BY ALL THE MAJOR MEDIA IN THE UNITED STATES. THE WIRE SERVICES AS WELL. SO IT'S A GOOD WAY TO GET A MESSAGE OUT TO THE GENERAL POPULATION. IT'S A VERY BRIEF REPORT. THE OTHER WAY TO DO THIS IS THROUGH AN ACADEMIC JOURNAL WHERE YOU'RE ALLOWED TO HAVE MORE DETAILS BUT THIS IS NOT QUITE SUCH A BIG AUDIENCE. THOSE WE'RE THINKING OF DOING ONE OR MAYBE BOTH OF THESE ROUTES TO GET THE MESSAGE OUT. THAT'S WHERE WE STAND WITH ANALYZING THE EXISTING DATA WE HAVE. NOW WE CAN TALK ABOUT RESTRUCTURING. SO NATIONAL HEALTH INTERVEW SURVEY IS A BIG NATIONAL SURVEY, THEY HAVE THE STANDARDS AND EVERY 10 YEARS REDESIGN AND REFORMAT TO MAKE SURE IT'S STILL PERFORMING THE WAY THEY WANT IT TO PERFORM. THE BAD NEWS IS THAT THEY ARE CUTTING QUESTIONS FROM THE SURVEY SO THEY ARE CUTTING QUESTIONS OUT. THE REASON THEY ARE DOING THIS IS BECAUSE THEIR RESPONSE RATES HAVE BEEN GOING DOWN OVER THE YEARS LIKE MOST SURVEY RESPONSE RATES HAVE BEEN GOING DOWN AND CALCULATE THEY SHORTENED THE SURVEY THAT WILL INCREASE RESPONSE RATES, SOMETHING THEY WANT TO DO. THEY ARE IN DELIBERATIONS ABOUT HOW THAT WOULD HAPPEN. I WORK ON AN ARTHRITIS CHAPTER IN THERE. THERE WILL BE ARTHRITIS QUESTIONS CUT FROM THE NATIONAL HEALTH INTERVIEW SURVEY BUT WE'RE PREPARED FOR THAT FOR THE ARTHRITIS WORLD. THE GOOD NEWS IS THEY ARE PRETTY EXCITED ABOUT HAVING PAIN QUESTIONS IN HERE. SO THEY HAVE DECIDED THAT THEY WILL HAVE PAIN QUESTIONS AS PART OF A ROTATING MODULE EVERY TWO YEARS. THAT'S GOOD NEWS. A LOT OF CONDITIONS DON'T MAKE IT IN THERE AT ALL. THE ONE SLIGHT GLITCH TO THIS IS THAT THEY WANT TO USE A THREE-MONTH TIME HORIZON, NOT A SIX-MONTH TIME HORIZON. THE REASON THEY WANT TO DO THIS IS BECAUSE IT IS A PREVIOUSLY ESTABLISHED INTERNATIONAL STANDARD THAT WE DIDN'T KNOW ABOUT WHEN WE WERE DESIGNING OUR QUESTIONS. THAT THEY FEEL COMPELLED TO GO ALONG WITH THAT. EXPERTS IN OUR GROUP FEEL WE CAN LIVE WITH THAT SORT OF CHANGE, STILL BE HIGH IMPACT, JUST USING THREE-MONTH TIME HORIZON INSTEAD OF SIX-MONTH TIME HORIZON. VERY GOOD NEWS IS THAT THEY ARE CONSIDERING ADDING QUITE A FEW OTHER QUESTIONS ON PAIN. SO THEY HAVE ONE ON WORK LIMITATIONS ATTRIBUTABLE TO PAIN BEING CONSIDERED RIGHT NOW. THESE ARE ALL UNDER CONSIDERATION. THERE'S NO FINAL WORD ON THIS. BUT THIS IS A PARTICULARLY IMPORTANT BECAUSE THEY WERE TRYING TO GET RID OF QUESTIONS THAT ATTRIBUTE PROBLEMS TO A ARE CONSIDERING THIS FOR PAIN SO THAT'S VERY GOOD. BEING ABLE TO ATTRIBUTE SOMETHING TO PAIN IS A VERY POWERFUL MESSAGE THAT WE HAVE IF WE CAN KEEP THAT IN THERE. NEXT TWO ARE STARRED. THEY LOOK FAMILIAR, HOW HAS PAIN AFFECTED YOUR FAMILY, SIGNIFICANT OTHERS, BOTH 2020 OBJECTIVES. WE WILL NOT ACHIEVE THEM FOR HEALTHY PEOPLE 2020 BUT THIS WILL GIVE AN OPPORTUNITY TO ADD TO HEALTHY PEOPLE 2030 WHICH ALSO THEY CHANGE EVERY TEN YEARS AS WELL AND WE'LL ADD THOSE OBJECTIVES AT THAT TIME AND HAVE A WAY TO MEASURE THEM. FINALLY THEY ARE LOOKING AT QUITE A NUMBER OF QUESTIONS GETTING AT THE ANATOMICAL SITE OF PAIN, THIS SURPRISED ME A BIT. I DON'T KNOW WHETHER THIS IS THEIR WISH LIST OF THINGS BUT THIS IS IN PLAY AND COULD HAPPEN, SOMETHING PEOPLE WANTED TO SEE. WE'LL SEE WHAT COMES OF THAT. FINALLY I PUT DOWN OPIOIDS THERE. I THINK A LOT OF THEIR INTEREST IN PAIN HAS TO DO WITH INTEREST IN OPIOIDS AS WELL. THEY ARE GETTING AT THE ENTANGLEMENT OF THE TWO PROBLEMS, WORKING FOR THE BENEFIT OF THE NATIONAL SURVEY. I WILL STOP THERE AND TAKE ANY QUESTIONS PEOPLE HAVE. YES? >> CHAD, WHEN DO YOU THINK YOU'LL HAVE THE 2016 DATA ANALYZED? >> WELL, THE GOOD THING IS WE'VE BEEN WORKING WITH NCHS ANALYSTS. THEY GET AN EARLY VERSION, WORKING THROUGH THE SPRING AND SUMMER. PUBLIC VERSION CAME OUT IN AUGUST I THINK SOMETIME. >> (INAUDIBLE). >> THEY PUBLISHED A TINY VERSION IN THE MWR VERSION ONE TIME. WE'VE BEEN MEETING, AND I HOPE WE WOULD HAVE A DECISION MADE ON WHAT WE THINK WE LEARNED FROM THE 2016 DATA, ONCE WE HAVE THAT IT'S A MATTER OF DECIDING, OKAY, WHAT PIECE DO WE WANT TO PULL OUT FOR AN MMWR AND I THINK WITH THE GENERAL INTEREST IN PAIN AND OPIOIDS, ESPECIALLY AT CDC AND HHS, WITH ANY SORT OF PUSH FROM NIH OR WHATEVER, THEY WOULD BE WILLING TO SORT OF DO THAT RELATIVELY QUICKLY, MORBIDITY AND MORTALITY WEEKLY REPORT. THE JOURNAL ARTICLE WOULD JUST BE ON THE USUAL JOURNAL ARTICLE SCHEDULE. >> THANK YOU. >> YEAH. >> SO GREAT NEWS, CHAD. REALLY GREAT NEWS. THAT YOU REALLY PULLED THIS OFF. I REALLY APPRECIATE ALL THE WORK YOU DID TO GET THIS GOING. SO ANY PREVIEWS FOR US ON THE DATA? >> NO. [LAUGHTER] I CAN'T DO THAT. A LOT OF METHODS WORK SHOWED HIGH IMPACT PAIN DEFINITION PERFORMED AS YOU MIGHT EXPECT BASED ON OUTCOMES. >> THAT WAS GOOD. AND SO I WOULD ENCOURAGE YOU TO DO BOTH MMWR GETS A LOT OF ATTENTION, SO WHEN YOU KNOW, CAN YOU LET US KNOW WHEN THAT'S COMING OUT? IT WOULD BE GOOD IF WE HAD WARNING AND COULD GET SOME PRESS. >> I TRY TO SHARE THAT AS MUCH AS I CAN. WHAT I DO, SINCE AT CDC I'M CDC'S PAIN INTEREST ON ON THE SIDE, I DO THIS ON THE SIDE, THERE ISN'T REALLY A LOCUS OF PAIN INFORMATION AT CDC HISTORICALLY BECAUSE WE DEALT WITH INFECTIOUS DISEASE. CDC DOES A LOT WITH OPIOIDS BECAUSE WE MEASURE MORTALITY AND THERE'S BEEN OPIOID MORTALITY, SO CDC HAS BEEN ASSIGNED TO DEAL WITH THAT. THERE'S A LOT OF ATTENTION AND FDEs AND MONEY FOR THAT MY JOB IS TO SPREAD THE WORD WITHIN CDC ABOUT THESE PAIN ISSUES, AS WELL AS WITH YOU AND OTHERS OUT THERE. AGAIN, ANY NEW DATA THAT COMES UP IS A HOOK FOR THE MEDIA AND THEY TEND TO LOVE THIS STUFF. WE JUST HAVE TO TAKE ADVANTAGE OF THAT. >> I WANT TO GET A SENSE OF THE 2030 HEALTHY PEOPLE. WHEN DOES THAT GO INTO -- IN OTHER WORDS, WHEN IS THE DATA ACTUALLY COLLECTED FOR THAT, IF IT'S GOING TO BE REPORTED, HENCE THE 2030? >> FOR HEALTHY PEOPLE 2020, THE OBJECTIVES WERE FINALIZED IN 2009 I THINK. WE CAN PROBABLY EXPECT 2030 OBJECTIVES TO BE FINALIZED IN 2019. NOW, TO BE AN OBJECTIVE YOU HAVE TO HAVE AT LEAST TWO DATA POINTS DURING THAT DECADE. PEOPLE THAT ORGANIZE HEALTHY PEOPLE DON'T HAVEFULLY MONEY. SO IF YOU WANT TO BE HEALTHY PEOPLE OBJECTIVE, YOU NEED TO GET THE DATA DONE SOME WAY YOURSELF. THE ONE GOOD THING I THINK ABOUT THE PAIN QUESTIONS WE HAVE IN HERE IS I THINK THEY ARE GOING TO BE PART OF A CORE ROTATING MODULE WHICH DOES NOT INVOLVE ANY SPENDING ON OUR PART HERE. I HOPE THAT'S THE CASE BUT WE'LL SEE. SO IF IT'S ROTATING EVERY TWO YEARS WE WOULD START SEEING DATA IN 2020 OR 2019 EVEN POSSIBLY. EVERY TWO YEARS AFTER THAT, TO SEE HOW THINGS ARE CHANGING. THIS ACTUALLY FITS IN VERY WELL WITH THE POPULATION RESEARCH WORK GROUP THAT I'M WORKING ON WITH RICHARD NAHAN. WE JUST GOT STARTED WORKING ON THOSE ISSUES AND WE'RE TRYING TO IMPLEMENT NATIONAL PAIN STRATEGY FROM THAT. >> I'M CONFUSED. WHAT YOU'RE SAYING IS WE COLLECTED THIS DATA NOW IN 2016. ARE THOSE TWO QUESTIONS THAT WE'VE HAD GOING TO BE IN IT AGAIN, ANOTHER, WHAT, 2018? >> NO. THEY WON'T. BUT THEY ARE GOING TO GIVE US A HEAD START ON WHAT'S GOING TO -- WHAT THE ISSUES ARE. THEY WILL STAND BY THEMSELVES IS WHAT SOMETHING LOOKED LIKE IN 2016 AND 2017. THE QUESTIONS STARTING IN 2019 ARE SIMILAR AGAIN. THEY MIGHT GIVE US A LITTLE DIFFERENT ESTIMATE BUT WE'LL BE USING THAT THREE-MONTH TIME PERIOD STARTING FROM 2019 INTO THE FUTURE. BUT I THINK WHAT WE DO IN 2016 AND 2017 WILL, AGAIN, GIVE US A LOT OF EXPERIENCE ON HOW TO RELATE, TO LOOK NOT ONLY AT THE PAIN QUESTIONS IN THERE BUT HOW THESE PAIN QUESTIONS RELATE TO ALL THE OTHER QUESTIONS IN THERE. ALWAYS A LOT OF COMORBIDITY ISSUES. THE SURVEY ASKS ABOUT CONDITIONS LIKE ARTHRITIS AND CHRONIC BACK PAIN AND SUCH. SO IT WILL GIVE US A CHANCE TO DECIDE WHAT ARE THE RESEARCH QUESTIONS THAT WE HAVE FROM A POPULATION RESEARCH POINT OF VIEW. ANSWER THEM WITH THESE OLDER DATA AND THEN BE READY WHEN THE 2019 DATA BECOME AVAILABLE IN 2020, ACT FAST, ANALYZE THOSE. DOES THAT ANSWER YOUR QUESTION? >> YES, THANK YOU. OKAY. YEAH? >> YEAH, SO I THINK IT'S GREAT THAT THEY ARE INTERESTED IN THE ANATOMICAL DISTRIBUTION OF PAIN SO I HOPE THAT MAKES IT IN. HAS THERE BEEN DISCUSSION OF LOOKING AT THE DURATION OF PAIN? >> JUST THE INITIAL QUESTION OF CHRONICITY, THREE MONTHS OR SIX-MONTH TIME PERIOD ON MOST DAYS, OR EVERY DAY. NOT BEYOND THAT. BUT THAT'S SOMETHING WE STILL CAN RAISE, I THINK, DURATION OF PAIN, SEVERITY OF PAIN ARE ALL ISSUES OF INTEREST TO US. EACH QUESTION HAS A COST, EITHER DIRECTLY IN DOLLARS OR IN SOME OTHER WAY, YOU KNOW. WE ASKED THOSE QUESTIONS ON DELAYS OR SEVERITY, WE MAY LOSE QUESTIONS ON ANATOMY. WE DEALING WITH ALL THAT. WE'LL TRY TO KEEP PEOPLE AWARE OF WHAT THE LATEST NEGOTIATIONS ARE. YEAH? >> THERE'S A RED LIGHT ON YOUR MICROPHONE. I THOUGHT YOU HAD A QUESTION. OKAY. ANYTHING ELSE? OKAY. >> THANKS VERY MUCH, CHAD. THAT WAS A NICE UPDATE. WE HAVE PROBABLY TEN MINUTES BEFORE DR. COLLINS IS HERE. ANYTHING YOU WANT TO TALK ABOUT, WALTER? >> LINDA, IF YOU HAVE A FEW MINUTES AS A FOLLOW-UP WITH THIS, I KNOW THAT RICHARD AND HEIN HAD DONE CREATIVE EPIDEMIOLOGY RESEARCH WITH OLD DATA, AND NOW THAT WE HAVE THIS NEW DATA CROSS-REFERENCED WITH OLDER DATA, I BET HE COULD DO EVEN MORE CREATIVE RESEARCH IF THAT WAS POSSIBLE. I DON'T KNOW WHAT ENABLED HIM TO DO THAT FINANCIALLY BUT IS THAT A POSSIBILITY? >> I THINK HE PROBABLY WANTS TO. HE'S SEARCHING -- SERVING AS CO-CHAIR WITH CHAD. ONCE THE SURVEY DATA CAME IN, HE HAS A STATISTICIAN ON. MAYBE DAVID SHURTLEFF WANTS TO SAY MORE. >> RICHARD IS A FULL-TIME EPIDEMIOLOGIST IN THE INSTITUTE WORKING ON SURVEYS INCLUDING THE NHIS, AND WE DO RELY ON CDC AND CENTER FOR STATISTICS TO HELP US SO THE PARTNERSHIP IS CRITICAL. HE HAS ONE OTHER FULL-TIME EQUIVALENT WORKING WITH HIM AS WELL, RICHARD DOES. SO WE'RE COMMITTED TO PUSHING OUT THESE DATA AS FAST AS POSSIBLE. HE'S ALREADY PUBLISHED SOME VERY INTERESTING DATA ABOUT PREFERENCE OF CHRONIC PAIN. HE'S VERY COMMITTED TO THIS. WE HAVE A VERY GOOD RELATIONSHIP WITH YOU, CHAD AS WELL. >> AN IMPORTANT QUESTION TO ASK. RIGHT, NOW WE'RE NEGOTIATING WHAT QUESTIONS WILL GET IN THERE. IT DOESN'T MEAN THE NATIONAL CENTER FOR HEALTH STATISTICS WILL HAVE TIME AND WILLINGNESS TO ANALYZE IT THEMSELVES. THEY MAY DO THAT THEMSELVES BECAUSE THEY VIEW THE PAIN OPIOID CONNECTION AS SOMETHING USEFUL FOR THEM TO BE VISIBLE FOR THEM BUT IT'S GOOD TO HAVE SOMEBODY LIKE NAN OR CDC READY TO JUMP IN. WE LIKE TO GET THE DATA OUT AS QUICKLY AS POSSIBLE. >> THERE'S THE DATA, THE ANALYSIS, AND THEN THE MOST IMPORTANT PART OF THIS IS PUBLICIZING IT. WE'VE GOT TO GET THAT DATA OUT THERE TO CREATE PUBLIC AWARENESS BECAUSE THAT'S THE ONLY THING THAT'S GOING TO MOVE THE NEEDLE FORWARD WITH PAIN, PERIOD. AND SO, YOU KNOW, THE COVERAGE THAT RICHARD GOT FROM KAISER ON THAT ONE PIECE WAS FABULOUS. I MEAN, IT REALLY MADE HEADLINES. SO THE MORE WE CAN DO TO GET NOTICED THAT THIS DATA IS COMING OUT SO WE CAN CONTACT JOURNALISTS AND MAKE SURE IT'S POSSIBLED IN POPULAR VERSUS JOURNALS. I LOVE JOURNALS BUT WE'VE GOT TO GET THIS IN THE PUBLIC DOMAIN. >> GOOD POINT. WE HAVE A VERY GOOD COMMUNICATIONS DEPARTMENT AND WE WILL PUSH THAT INFORMATION TO THE PRESS. EVEN IF IT'S PUBLISHED IN A PROFESSIONAL JOURNAL WE'LL DO A PRESS RELEASE. THAT INFORMATION GETS PUSHED IN A WAY THE PUBLIC CAN APPRECIATE WHAT WE'RE DOING AND WE HAVE AN OPPORTUNITY TO TALK TO THE LAY PRESS AS WELL TO PUSH THAT INFORMATION FORWARD. WE MAKE EVERY EFFORT TO DISTRIBUTE THAT INFORMATION BROADLY. IT'S A VERY GOOD POINT WE HAVE TO BE AWARE OF. IF IT SITS IN A PROFESSIONAL JOURNAL IT'S NOT DOING ANYBODY ANY GOOD. >> RIGHT. >> NOT THE IMPACT WE HOPE. >> CHAD, ANY INSIGHT AS TO WHAT KIND OF QUESTIONS RELATED TO OPIOID USAGE, WE'LL BE COMING FORWARD, THEY WILL BE IN 2030, IS THAT CORRECT? GOOD WELL, OPIOID QUESTIONS WILL BE IN THE SAME YEAR THE PAIN QUESTIONS COME OUT, PROBABLY 2019 OR 2020, DEPENDING HOW THEY DO IT. YOU KNOW, I'VE BEEN PART OF THOSE DISCUSSIONS AS WELL. AND THOSE ARE MUCH MORE DIFFICULT QUESTIONS TO TRY TO DEFINE. THEY ARE EVEN HAVING TROUBLE DEFINING WHAT AN OPIOID IS FOR THE PUBLIC. THESE ARE SELF-REPORT SURVEYS SO PEOPLE HAVE TO RECOGNIZE WHAT THEY ARE TAKING IS AN OPIOID, AND THEY DON'T ALWAYS DO THAT. THERE'S A LOT OF DISCUSSION HOW DO YOU DO THAT ACCURATELY, MANY OTHER QUESTIONS RELATED TO OPIOIDS THAT THEY ARE BEHIND US IN TERMS OF PAIN IS READY, WE KNOW WHAT THEY WANT TO DO. BUT OPIOID, USING A NATIONAL SURVEY OF SELF-REPORT, MUCH TOUGHER QUESTION. >> IF THERE ARE NO OTHER ISSUES WITH THAT COULD I TAKE US BACK TO SOMETHING THIS MORNING? DR. SINGH WAS SUPPOSED TO TALK ABOUT THE INTERSECTION BETWEEN -- THE INTERSECTION WITH I RPCC AND PAIN TASK FORCE, I MUST HAVE MISSED IT, I'M NOT SURE HOW THEY RELATE OR IF THEY DO. IT WAS AT 10:55 WHEN DR. SINGH SPOKE BUT I THINK I NEED LINDA TO ANSWER THE QUESTION. SHE MAY KNOW. WALTER, MY QUESTION, MAYBE LINDA IS GOING TO HAVE TO ANSWER THIS, THE LINE BENEATH THE PAIN MANAGEMENT TASK FORCE, CARA, INTERSECTIONED WITH IPRCC. WHAT IS THAT INTERSECTION? IS THERE ANY RELATIONSHIP WHATSOEVER OR IS THIS DUPLICATION? >> NO, IT'S THE INTERSECTION WITH THE RESEARCH RECOMMENDATIONS THAT COME FROM THE IPRCC AND THAT COULD BE BY WAY OF THE RESEARCH STRATEGY. SO DR. SINGH HAS BEEN VERY COMMUNICATIVE WITH US ABOUT WHERE THE PAIN TASK FORCE GETS AND SO HOPEFULY WITH THIS INITIAL CONVERSATION WE'LL KEEP THE COMMUNICATION BACK AND FORTH WITH HER. >> WALTER WAS ASKING IF THERE ARE OTHER SUPER BRIEF UPDATEES WE COULD GIVE. CHRIS JONES CAME LAST YEAR TO THE FACE-TO-FACE MEETING. ACTUALLY I THINK HE CALLED IN BY WEBEX AND TALKED ABOUT A PILOT STUDY THAT THEY HAD DONE TO LOOK AT REIMBURSEMENT, AND POLICY PROTOCOLS FOR COVERAGE FOR LOW BACK PAIN. SO IT INCLUDED A SMALL -- LIKE ONE OF THE PHARMACY, I THINK IT WAS PUREMARK AND ONE STATE MEDICAID AND ONE PRIVATE INSURER TO SEE WHAT THEY COVERED, HOW MUCH OF WHAT THEY COVERED FOR DRUGS AND FOR NON-PHARMACOLOGICAL TREATMENTS FOR LOW BACK PAIN. AND SO THAT STUDY GOT CLOSED OUT, GOT SOME GOOD INFORMATION FROM IT. AND THEY EXPANDED IT TO A MUCH -- THEY ARE EXPANDING IT. THEY ARE IN THE PROCESS OF DOING THE STUDY NOW THROUGH THE SAME CONTRACTOR, DONE THROUGH JOHNS HOPKINS. THEY DID A REALLY NICE JOB WITH IT. SO THEY HAVE EXPANDED THE STUDY TO LOOK NATIONWIDE. THEY ARE LOOKING AT 13 STATE MEDICAID PROGRAMS, THEY ARE LOOKING AT OFF THE TOP OF MY HEAD I DON'T REMEMBER WHICH OF THE BIG HEALTH CARE SYSTEMS BUT IT'S A MUCH BIGGER STUDY. IT'S STILL TARGETED TO LOW BACK PAIN AND THERE ARE A LOT MORE INTERVIEW QUESTIONS THAT THEY TALKED TO THE COMPANIES ABOUT WHERE IT WOULD BE HELPFUL TO SORT OF INFORM THE DATA THAT THEY ARE COLLECTING FROM THEIR RECORDS. AND SO THAT SHOULD BE COMPLETED IN ANOTHER THREE OR FOUR MONTHS. I THINK THAT WILL BE REALLY HELPFUL JUST TO LOOK AT WHAT DRUGS ARE COVERE, HOW MANY ARE COVERED. THE QUESTIONS ARE COMING UP, ARE THE INSURANCE COMPANIES COVERING OPIOIDS WHEN THERE ARE BETTER OPTIONS EVEN IN THE PHARMACEUTICAL TREATMENT, SO DR. COLLINS IS HERE. AND WELCOME, DR. COLLINS. AND REBECCA. REBECCA BAKER. AND I'LL TURN IT OVER TO WALTER. >> THANK YOU, FRANCIS. THANKS FOR JOINING. I WONDERED IF IT MIGHTING BE ABOUT FOR FOLKS TO GO AROUND THE TABLE TO LET DR. COLLINS KNOW, OF COURSE HE'S THE DIRECTOR OF NIH, AND AS YOU'LL BE HEARING HE'S A CONVERT TO OUR MISSION, WHICH IS -- [LAUGHTER] -- TO STAMP OUT PAIN AND OPIOID ADDICTION. WE'RE ALL ON THE SAME TEAM HERE, FRANCIS. AND SO WHY DON'T WE GO AROUND THE TABLE. MARTHA, YOU KNOW MARTHA. >> HI. >> CATHY UNDERWOOD, CHIEF EXECUTIVE OFFICER OF THE AMERICAN PAIN SOCIETY. >> SHARON HERTZ DIRECTOR FOR DIVISION OF ANESTHESIA AT FDA CDER. >> CINDY STEINBERG. >> JAN CHAMBERS PRESIDENT OF NATIONAL FIBROMYALGIA AND CHRONIC PAIN ASSOCIATION. >> CHRISTINA SPELLMAN MAY DAY FUND. >> JUDY PACE FROM NORTHWESTERN. >> PENNY COWEN. >> RIC RICCIARDI. >> LONGER FILLINGIM UNIVERSITY OF MA. >> CHIP BUCKMIRE. >> DAN CARR, TUFTS PAIN RESEARCH EDUCATION AND POLICY. >> BILL MAXNER DUKE UNIVERSITY. >> THANKS FOR THE OPPORTUNITY TO SPEAK WITH YOU, A THREE-PERSON PRESENTATION BETWEEN MYSELF, NORA AND WALTER, TO BRING YOU UP TO SEED ON SOMETHING THAT'S BEEN MOVING VERY QUICKLY OVER THE COURSE OF THE PAST FEW WEEKS AND WHICH WE THOUGHT THE IPRCC WOULD BE PARTICULARLY INTERESTED IN, GIVEN YOUR DEDICATION TO THIS ISSUE OF COMING UP WITH BETTER SOLUTIONS FOR ACUTE AND CHRONIC PAIN AS WELL AS COMING UP WITH WAYS TO DEAL WITH THIS REALLY TERRIBLE PUBLIC HEALTH EMERGENCY, OPIOID ADDICTION AND OVERDOSE. I'M JUST GOING TO LAY OUT SOME GENERAL BACKGROUND OF WHERE WE HAVE COME FROM IN A PRETTY INTENSE EFFORT THAT HAS CAUSED ME TO SPEND MORE HOURS IN CONFERENCE ROOMS WITH NORA AND WALTER THAN I EVER THOUGHT WOULD HAPPEN IN MY LIFE. BUT ALL IN A GOOD CAUSE. AND THEN I ASKED THEM TO GO THROUGH SOME OF THE DETAILS OF WHERE WE ARE RIGHT NOW AND WHAT I THINK IS AN UNPRECEDENTED AND AUDACIOUS EFFORT HERE TO TRY TO SEE IF THERE'S A WAY THAT WE CAN TAKE SCIENTIFIC SKILLS, CAPABILITIES AND PROMISES AND BRING THEM TO BEAR AT A TIME OF PARTICULAR URGENCY ON THIS SET OF ISSUES. YOU'RE ALL FAMILIAR WITH THE CRISIS WE'RE FACING. BY THE WAY, PRIMARILY I'LL BE TALKING ABOUT OPIOID OVERDOSE AND ADDICTION ISSUES. I DON'T IN ANY WAY MEAN TO MINIMIZE THE FACT THAT WE NEED TO BE SURE WE'RE COMING UP WITH EFFECTIVE STRATEGIES TO HELP PEOPLE, 25 MILLION PEOPLE WHO SUFFER FROM PAIN EVERY DAY. I'M WORRIED SOMETIMES THERE SEEMS TO BE A SENSE THAT IT'S ONE OR THE OTHER. ACTUALLY WE HAVE TO COME UP WITH SOLUTIONS THAT ARE EFFECTIVE FOR BOTH. HERE YOU SEE DRAMATICALLY WHAT'S HAPPENED IN THE SPACE OF THE LAST TWO DECADES IN TERMS OF THE WAY IN WAY OPIOID ADDICTION CRISIS HAS AFFECTED VIRTUALLY ALL PARTS OF THE COUNTRY, PARTICULARLY SO IN CERTAIN PLACES LIKE THE APPALACHIAN REGION AND THE SOUTHWEST AND YOU'RE ALL FAMILIAR I THINK WITH THE DEVASTATING STATISTICS OF THE NUMBER OF PEOPLE WHOSE LIVES ARE BEING LOST EVERY DAY TO THIS UNPRECEDENTED DRUG OVERDOSE EPIDEMIC NOW MADE MUCH WORSE BY FENTANYL AND CARFENTANIL FINDING THEIR WAY IN THE HEROIN SUPPLY. WE DO WANT TO PAY CLOSE ATTENTION TO THE FACT THAT WE HAVE 25 MILLION ADULTS WHO HAVE PAIN EVERY DAY IN THE U.S. AND THAT OPIOIDS ARE OVERPRESCRIBED AND NOT EFFECTIVE FOR MANY OF THOSE CASES OF CHRONIC PAIN. MAYBE THIS SHOULD HAVE BEEN A LITTLE BIT QUALIFIED IN THE WAY THAT'S STATED. MORE THAN TWO MILLION AMERICANS ESTIMATED TO BE ADDICTED TO OPIOIDS, MOST OF THOSE 80% STARTING WITH PRESCRIPTION MEDICINES. SO THIS IS AN EPIDEMIC THAT IN MANY WAYS HAD ITS ORIGINS IN CHANGES THAT WERE MADE IN TERMS OF PRESCRIBING PRACTICES IN THE LATE 1990s DONE WITH ALL GOOD INTENTIONS WITH MISUNDERSTANDING ABOUT WHAT PEOPLE PERCEIVED AT A LOW RISK OF ADDICTION FOR PEOPLE WHO HAD ACTUAL PAIN AND TURNED OUT TO BE ABSOLUTELY WRONG. WE DO KNOW M.A.T. IS AVAILABLE AND EFFECTIVE FOR OPIOID USE DISORDERS. BUT IS DRASTICALLY UNDERUTILIZED. AND THERE'S A LOT WE DON'T KNOW ABOUT IT. PARTICULARLY HOW LONG TREATMENT NEEDS TO BE KEPT IN PLACE IN ORDER TO AVOID RELAPSE, AND IT LOOKS AS IF THE ANSWER IS PROBABLY QUITE A LONG TIME. IN MANY PROGRAMS THAT ARE CURRENTLY BEING SUPPORTED, BY FUNDS FROM PLACES LIKE THE 21ST CENTURY CURES BILL, MAY IN FACT BE INSUFFICIENT IN THEIR DURATION. THINK IT'S FAIR TO SAY WE HAVE REVOLUTIONIZED OUR UNDERSTANDING OF ADDICTION AND PAIN, THERE'S A LOT OF GREAT SCIENCE HERE BUT WE HAVE LIMITED ALTERNATIVES TO THE THREE MAJOR WAYS OF TREATING ADDICTION AND ARE WORRIED ABOUT WHETHER OVERDOSE REVERSAL WITH NARCAN WILL BE SUFFICIENT TO DEAL WITH MORE POTENT OPIOIDS PARTICULARLY FENTANYL, CARFENTANIL. AND I THINK WE CAN ALL AGREE IT IS REALLY UNFORTUNATE WE HAVE A LIMITED REPERTORY PAIN MEDICINESES. WE'D LIKE TO SPEED UP THE PROCESS OF DEVELOPING AND GETTING APPROVAL OF ALTERNATIVES. THIS IS A SLIDE I BORROWED FROM NORA, A NICE WAY OF GRAPHICALLY SHOWING WHAT ARE THE THREE AREAS PARTICULARLY IMPORTANT TO FOCUS ON HERE IN DEALING WITH THE CRISIS. ADDICTION TREATMENT OVERDOSE REVERSAL AND THEN PAIN MANAGEMENT. WE WANT TO TALK ABOUT ALL THREE OF THOSE IN THE COURSE OF THIS AFTERNOON'S TRIO OF PRESENTATIONS. IT'S FAIR TO SAY NIH HAS A LOT OF EQUITIES IN THIS SPACE. A LOT OF RESEARCH GOING ON THAT HAS LED TO SIGNIFICANT ADVANCES THAT WE CAN POINT TO. AND CAN BUILD UPON. SO THIS IS SORT OF A COLLAGE FORM BUT SUCH THINGS AS VERY BASIC SCIENCE EFFORTS THAT HAVE REVEALED POTENTIAL TARGETS FOR ANALGESICS ON THE BASIS OF GENETIC STUDIES OF INDIVIDUALS WHO HAVE CHRONIC CONGENIC PAIN AND MISSPELLINGS IN SODIUM CHANNELS, PARTICULARLY NAV 1 AND 7. ANOTHER POTENTIALLY APPEALING APPROACH IS TO TAKE APART WHAT THE OPIOID RECEPTOR ACTUALLY IS ALL ABOUT AND RECOGNIZE THAT THERE ARE TWO OUTCOMES OF BINDING MORPHINE TO THAT RECEPTOR, ONE THROUGH A G-PROTEIN WHICH LEADS TO PAIN RELIEF AND THE OTHER THROUGH BETA ARRESTIN, THERE'S SOME POSSIBILITY, FAR FROM A DONE DEAL, THAT ONE CAN IDENTIFY AGONISTS TO THIS RECEPTOR WHICH WOULD ACTIVATE G-PROTEIN BUT NOT THE BETA ARRESTIN, YOU MIGHT GET A BIAS THAT MIGHT BE SAFE WITHOUT THE OTHER ISSUES, SOMETHING WE'RE WORKING ON. WE IN THIS CASE, A LOT OF WHAT TIME TALKING ABOUT IS WITHIN THE DRUG ABUSE INSTITUTE. PROBUTHINE IN A WAFER, A FORM OF BUPRENORPHINE, A STEP IN COMNG UP WITH MEANS OF M.A.T. THAT DOESN'T REQUIRE DAILY ADMINISTRATION, WHICH IS ALSO ASSOCIATED WITH HIGH RELAPSE RATE AND DEVELOPMENT OF NASAL SPRAY VERSION OF NALOXONE HAS BEEN AN EFFORT NIDA WORKED WITH A COMPANY TO ACHIEVE AND HAS NOW BECOME THE MAJOR SOURCE OF OVERDOSE REVERSAL THAT IS USED BY FIRST RESPONDERS AND DOESN'T REQUIRE ANY SPECIAL TRAINING OR USE OF A NEEDLE. VIVITROL, INJECTABLE FORM OF NALTREXONE, ANOTHER USEFUL ALTERNATIVE TO ASSIST PEOPLE RECOVERING FROM ADDICTION. WE AGREE IT WOULD BE GREAT IF HAD YOU A VERSION OF THIS THAT DIDN'T LAST A MONTH BUT MAYBE LASTED SIX MONTHS. THAT'S GOING TO BE CHALLENGING JUST BECAUSE THE VOLUME THAT WOULD HAVE TO BE ASSOCIATED WITH THAT BUT THERE ARE POTENTIAL OTHER ALTERNATIVES. NIH HAS BEEN IN THIS SPACE FOR A WHILE BUT I THINK WHAT WE'RE TRYING TO SAY IS WE NEED TO RATCHET THIS UP WITH ALL OF THE COLLEAGUES AND COLLABORATORS WE CAN FIND TO TRY TO SPEED UP FINDING SOLUTIONS AT A TIME OF SUCH A PUBLIC CRISIS. YOU COULD ALSO IMAGINE WE NEED TO BUILD THIS BUILDING THAT BOTH TACKLES THE PROBLEM OF PAIN WITH SAFE EFFECTIVE NON-ADDICTIVE STRATEGIES, COMES UP WITH SOLUTIONS FOR ADDICTION IN TERMS OF TREATMENT AND PREVENTING AND REVERSING OVERDOSE BUT NONE OF THAT WORKS UNLESS YOU HAVE A WAY TO TEST TREATMENTS WHICH MEANS A NATIONAL RESEARCH NETWORK, BUILDING ON SOME OF THE CAPABILITIES THAT ARE ALREADY THERE LIKE THE CLINICAL TRIALS NETWORK, AND EMERGENCY ROOM CAPABILITIES, IN FACT EXTENDING IT TO MAKE IT POSSIBLE TO DO MORE OF THIS, MORE QUICKLY. HOW DO WE GET DOWN THIS ROAD HERE OVER THE LAST FEW MONTHS OF WHAT IS NOW A VERY INTENSE EFFORT INVOLVING NIH, FDA AND MULTIPLE COMPANIES? IN APRIL, AFTER DIRECT INSTRUCTION FROM THE PRESIDENT IN A MEETING I HAD WITH THE PRESIDENT IN THE OVAL OFFICE IN MARCH, I MADE THE CASE TO THE HEADS OF R&D AND BIG PHARMA AT A MEETING ONCE A YEAR, RIGHT THEN WHICH WAS TIMELY, THAT IT WAS GOING TO BE ESSENTIAL IF WE'RE GOING TO TACKLE THIS, TO HAVE AN UNPRECEDENTED LEVEL OF PARTNERSHIP BETWEEN PUBLIC AND PRIVATE SECTORS. INDUSTRY AGREED AROUND THAT TABLE THAT THAT WAS SOMETHING THEY WOULD MAKE A PRIORITY BUT WE HAD TO FIGURE OUT THEN WHAT WOULD IT LOOK LIKE. THAT'S LED TO A SERIES OF CUTTING EDGE SCIENCE MEETINGS HELD AT NIH INVOLVING ACADEMIA, INDUSTRY AND GOVERNMENT TO IDENTIFY SPECIFIC NEW APPROACHES WHERE THIS KIND OF PARTNERSHIP WOULD SPEED UP THE PROCESS OF DEVELOPING WHAT WE NEED IN TERMS OF OPIOID ABUSE AND TREATMENT OF PAIN. THAT THEN LED TO ANOTHER SERIES OF DISCUSSIONS IN SEPTEMBER FROM LARGE AND SMALL PHARMACEUTICAL COMPANIES, INCLUDING SUPPORT FROM PHARMA, THE TRADE ORGANIZATION, PART OF THIS. A MEETING IN TRENTON CONVENED BY GOVERNOR CHRISTY IN MID-SEPTEMBER. MULTIPLE CEOs FROM PHARMACEUTICAL COMPANIES ALSO REPRESENTED. I WOULD SAY ALONG THE WAY THE MOMENTUM BUILT BEHIND THIS AND THERE WAS STRONG ENTHUSIASM FOR PUSHING THIS FORWARD. THAT WAS USED TO THEN DESIGN TWO NEW PARTNERSHIP EFFORTS. NORA AND WALTER WILL TELL YOU MORE ABOUT THOSE IN DETAIL SO I'LL GIVE YOU THE VERY BASIC OUTLINE. PROJECT 1 TO FOCUS ON OPIOID USE DISORDERS AND PREVENT REVERSE OVERDOSE. NEW TREATMENTS, TREATMENTS FOR OVERDOSE PREVENTION AND DEVICES TO PREVENT MISUSE AND OVERDOSE. PROJECT 2 IS THIS ACCELERATION OF DEVELOPMENT OF NON-ADDICTIVE PAIN THERAPIES TO ADVANCE ONES IN THE CURRENT PIPELINE AND THERE ARE QUITE A NUMBER OF PRE-CLINICAL AND EVEN A FEW CLINICAL STUDIES ON NEW PAIN MEDICINES THAT WOULD NOT BE EXPECTED TO HAVE THE SAME ADDICTIVE POTENTIAL BUT NEED FOR BIOMARKERS TO PREDICT RESPONSES TO BE ABLE TO TAKE PAIN SYNDROMES AND APPROPRIATELY DIVIDE THEM UP INTO SUBSETS THAT HAVE DIFFERENT PATHOGENESIS. ESTABLISH MORE OF A DATA SHARING COLLABORATIVE. THOSE ARE THE THINGS THAT SORT OF BUBBLED UP TO THE TOP AS BEING OF THE HIGHEST PRIORITY FROM BOTH PUBLIC AND PRIVATE SECTOR VIEW. THIS BY NO PARTICULAR ACCIDENT HAPPENS TO BE THE TWO AREAS WHERE THE PRESIDENT'S COMMISSION IN THEIR INTERIM REPORT AT THE END OF JULY POINTED TO NIH AND ASKED US TO HELP AND THESE VERY SAME ISSUES THAT I'VE JUST MENTIONED WERE OUTLINED THERE. THE FINAL REPORT IS DUE NOVEMBER 1 AND I'M QUITE SURE IT WILL ALSO HIGHLIGHT HOW THE SAME ISSUES BECAUSE OF THE CLOSE RELATIONSHIP WITH FOLKS WORKING ON THAT. SO WE'RE IN A SPACE OF RESPONDING TO THEIR CALL. WHERE ARE WE NOW? AFTER THESE MEETINGS IN SEPTEMBER, WE BASICALLY SENT OUT A REQUEST AND WE IN THIS CASE IS NIH JOINTLY WITH STEVE UBAL OF PHARMA ASKING COMPANIES WHETHER THEY WERE IN FOR THE NEXT STEP WHICH IS TO NAME A SENIOR PERSON WHO COULD REPRESENT THE INTEREST OF THEIR COMPANY TO TAKE PART IN A SERIOUS DESIGN PHASE OF A WORK PLAN THAT WOULD TACKLE THESE TWO AREAS THAT I'VE JUST MENTIONED AND WHICH NORA AND WALTER WILL GO THROUGH IN MORE DETAIL. 33 COMPANIES CAME BACK WITH A YES ON THAT. THAT'S PRETTY UNPRECEDENTED TO HAVE THAT NUMBER. AND SOME OF THOSE ARE SMALLER COMPANIES THAT ARE ACTUALLY ALREADY IN THIS SPACE WORKING ON FORMULATION FOR INSTANCE OF DIFFERENT KINDS OF WAYS TO DELIVER M.A.T. OR OVERDOSE TREATMENT. AND SOME OF THEM ARE BIG PHARMAs WHO ARE INTERESTED PARTICULARLY IN THE AREA OF DEVELOPING NEW NON-ADDICTIVE PAIN MEDICINES AND ARE CITED FDA IS PART OF THIS AS WELL BECAUSE THEY ARE PERCEIVED FDA AS POTENTIALLY HAVING A HIGH BARRIER FOR THESE KINDS OF NEW NON-ADDICTIVE PAIN MEDICINES AND KNOWING THAT FDA IS NOW SYMPATHETIC WITH HOW IMPORTANT THIS IS IS ENCOURAGING THEM PERHAPS TO CONSIDER PUTTING MORE INVESTMENT INTO IT. WE HAD A DISCUSSION JUST LAST FRIDAY, OCTOBER 20, OF THE REPRESENTATIVES OF THOSE 33 COMPANIES ABOUT WHAT THE NEXT STEPS WOULD BE. IT WAS IN THE HALLWAY RIGHT DOWN THERE, WE HAD THIS CALL. I THINK IT WENT EXTREMELY WELL. THE FOLLOW-UPS FROM THAT WHICH ARE DUE TOMORROW AT COB FOR EACH COMPANY TO SAY WHICH OF THE SUBSET PROJECTS, BECAUSE EACH HAS VARIOUS SUBCOMPONENTS, THEY WOULD LIKE TO TAKE PART IN AS FAR AS THE SPECIFIC DESIGN. I SUSPECT WE'RE GOING TO GET STRONG RESPONSES THERE. WE ALSO ARE GATHERING INFORMATION ABOUT WHAT THE COMPANIES CAN BRING TO THE TABLE HERE IN TERMS OF ASSETS AND TOGETHER WEAR WE'RE GOING TO PUT TOGETHER GOALS AND MILESTONES AND SPECIFIC BUDGET. WE OF COURSE AT NIH HAVE OTHER AREAS THAT DON'T NECESSARILY FIT WELL WITH THE PARTNERSHIP WHERE WE HAVEN'T GOTTEN AS MUCH EMBRACE, AT LEAST NOT YET WITH COMPANIES. WE WANT TO PUSH THOSE FORWARD , SUCH AS THE PUSH ON DEVICES, SUCH AS VACCINES, AREAS THAT WE THINK ARE PROMISING AND EVEN WITHOUT INDUSTRY ENTHUSIASM IS PART OF A PARTNERSHIP I THINK WE WANT TO PURSUE THOSE. WE AIM FOR DETAILED PROJECT PLAN IN DECEMBER. THIS IS REALLY FLAT-OUT FOR SOMETHING INVOLVING THIS MANY PARTNERS BUT WE'RE DETERMINED AND I THINK WE HAVE A LOT OF RECOGNITION OF THE URGENCY HERE. AND THIS IS GOING TO TAKE RESOURCES FROM BOTH THE PUBLIC AND PRIVATE SECTOR, A TOPIC STILL SOMEWHAT UP IN THE AIR IN TERMS OF EXACTLY WHERE THESE RESOURCES ARE GOING TO COME FROM BUT LOTS OF DISCUSSION TO DID THIS FORWARD AS QUICKLY AS IT NEEDS TO BE. THAT'S WHAT I WANTED TO PUT IN FRONT OF YOU BY WAY OF SETTING THE STAGE. I THINK NOW NORA AND WALTER CAN STEP UP AND GIVE YOU SOME MORE DETAILS ABOUT WHERE WE ARE WITH THESE AREAS. BEFORE I ASK NORA TO COME, ARE THERE SPECIFIC QUESTIONS FOR ME? I REGRET I'M GOING TO HAVE TO DASH OFF AFTER THIS TO OTHER THINGS THAT ARE CALLING TO ME. IT'S NOT A QUIET DAY OVER IN BUILDING 1. ANY QUESTIONS THAT I CAN HELP YOU WITH BEFORE WE GO ON? YES? >> DR. COLLINS, VERY IMPRESSIVE INITIATIVE. YOU KNOW, I'M JUST CURIOUS WHETHER YOU FEEL IMPLEMENTATION OF THIS PROCESS BY BIG PHARMA WHICH HAS BEEN GETTING OUT OF THE NEUROSCIENCE BASE INCLUDING PAIN, WHETHER THE THRESHOLD SET BY FDA WILL BE SUFFICIENT TO BRING THEM BACK, ARE THERE OTHER WAYS OR MEANS THAT WE CAN BRING PHARMA INTO THIS SPACE WITH GREAT ENTHUSIASM FOR WHA WE WANT TO DO? >> I THINK IT'S CLEAR THEY ARE RATCHETING UP THEIR INTERESTS SUBSTANTIALLY AND I THINK FDA AND STATEMENTINGS FROM JANET WOODCLOCK ABOUT THEIR WILLINGNESS TO REFRAME THE BAR IN TERMS OF TOLERANCE FOR ANY SIDE EFFECTS AT ALL, WHICH WAS PREVIOUSLY PERCEIVED AS BEING ESSENTIALLY ZERO, NOW THAT YOU HAVE TENS OF THOUSANDS OF PEOPLE DYING FROM OPIOIDS IT'S CLEAR AN ALTERNATIVE TO GIVES SOMEBODY INDIGESTION MAY NOT BE SO BAD IF IT'S POTENT AND NON-ADDICTIVE. THAT'S A BIG PUSH. OTHER FACTORS HAVE BEEN KICKED AROUND. I DON'T THINK SO FAR IT SEEMS ABSOLUTELY ESSENTIAL TO PUT THOSE ON THE TABLE BUT I WOULDN'T BE SURPRISED IF THEY CAME BACK UP. SUCH THINGS AS PRIORITY VOUCHERS, SUCH THINGS AS ACCELERATED APPROVALS. I THINK FDA HAS HINTED THEY WOULD BE QUITE FAVORABLE, MORE THAN HINTED. SCOTT GOTTLIEB HAS ACTUALLY SAID THIS, IF SOMEBODY BROUGHT FORWARD A NON-ADDICTIVE PAIN MEDICINE THEY WOULD TRY TO PUT THIS THROUGH, THE BREAK-THROUGH DESIGNATION AND GET IT APPROVED ON A SPEEDY TRACK AND NOT IN THE SLOWER PATHWAY. >> IS THERE ANY ROOM FOR THE INTEGRATIVE HEALTH PRACTICES, YOU HAVE YOUR OWN CENTER FOR NCCIH RECOGNIZING THIS IS A PUSH BY PHARMA BUT THE IDEA BEHIND INTEGRATIVE HEALTH IS HOW OTHER MODALITY IT'S LIKE MASSAGE, ACUPUNCTURE WOULD INTEGRATE, THERE IS NO SILVER BULLET DRUG SOLUTION TO THIS PROBLEM, LIKELY NEVER ABOUT BE, AND SHOULD WE NOT PARTICULARLY WITH LEADERSHIP OF NIH START HAVING THAT CONVERSATION NOW INSTEAD OF COMPARTMENTALIZING THIS ISSUE AGAIN WITH PHARMA, LOOKING FOR THAT MAGIC BULLET? >> YOU KNOW, GOOD QUESTION. CERTAINLY AS YOU SAY, WE NIH ARE INTENSELY INTERESTED IN LOOKING FOR THOSE KINDS OF INTEGRATIVE SOLUTIONS, AND ANY KIND OF TESTING WE'RE GOING TO BE DOING IN THE FUTURE ABOUT WAYS TO MANAGE CHRONIC PAIN ARE GOING TO NEED TO CONSIDER WHAT ALL THE MODALITIES ARE AND HOW POTENTIALLY THEY WORK IN A GIVEN SITUATION. WE'RE HAVING A DISCUSSION FOR INSTANCE ABOUT AN EFFORT TO UNDERSTAND TRANSITION FROM ACUTE TO CHRONIC PAIN AND PREDICTIVE FACTORS AND WHAT KIND OF INTERVENTIONS MIGHT BLOCK THAT TRANSITION THAT WERE NOT DRUGS BUT HAD OTHER KINDS OF VALUE. WHETHER YOU COULD CONVINCE PHARMA WHEN THEIR BUSINESS IS MAKING PILLS TO ACTUALLY PUT THEIR FINANCIAL RESOURCES INTO SPECIFIC EFFORTS THAT WOULD PROMOTE OTHER MODALITIES THAT MIGHT BE A LITTLE BIT OF A HARD SELL. BUT I DO THINK WE'RE KIND OF AT A UNIQUE MOMENT, RECOGNIZING WE HAVE A NATIONAL CRISIS, CERTAINLY THE WILLINGNESS OF LEADERS IN PHARMACEUTICAL INDUSTRY TO RECOGNIZE THEY HAVE A ROLE TO PLAY NOT JUST ABOUT THE FINANCIAL BOTTOM LINE IS PRETTY APPARENT AND WE SHOULD DO EVERYTHING WE CAN TO BUILD ON THAT. YES? >> EXCITED TO HEAR PAIN MAY GET COMMON FUND FUNDING, WHAT ARE YOUR THOUGHTS AFTER ALL THESE YEARS OF WAITING GET A COMMON FUND PROJECT. >> THE TIME IS RIGHT, ONE CAN EMPHASIZE HOW CRITICAL THIS IS IN TERMS OF AREA OF RESEARCH THAT NEEDS FOR ATTENTION. I THINK THE PARTICULAR PROJECT THAT'S BEING FORMULATED IN THIS INSTANCE HAS THE RIGHT KIND OF PROPERTIES TO BE COMMON FUNDABLE. IT'S STILL GOT SEVERAL STEPS TO GO THROUGH TO BE ABLE TO SAY THAT, YES, THIS IS GOING TO FIND ITS WAY INTO THE ON-RAMP, OF COURSE SOME DEPENDS ON WHAT HAPPENS TO THE BUDGET BECAUSE THE COMMON FUND IS PRETTY TIGHTLY SUBSCRIBED. ONCE THE DUST SETTLED, IF FY 18 BY THE TIME WE GET TO DECEMBER 8 LOOKS LIKE A GOOD YEAR FOR NIH AND SENATE AND HOUSE ARE INDICATING THEY WANT IT TO BE, THEN WE'LL HAVE MORE BREATHING ROOM TO TACKLE NEW THINGS IN THE COMMON FUND AND EVERYWHERE ELSE TOO. THANK YOU VERY MUCH. I'M GOING TO TURN IT OVER TO NORA, NEXT UP, AND I WILL BID YOU FAREWELL BUT THANK YOU FOR YOUR HARD WORK IN THIS SPACE AT A CRITICAL TIME. IT'S ALWAYS BEEN A CRITICAL TIME BUT THE VISIBILITY HAS NEVER BEEN MORE APPARENT THAN RIGHT NOW. >> GOOD AFTERNOON. I'M GOING TO TAKE FROM WHERE FRANCIS LEFT. AS YOU SEE THERE'S BEEN AN ENORMOUS AMOUNT OF WORK THAT HAS BEEN GOING ON ALL ALONG, VERY MUCH ACCELERATED WITH THE ENERGY AND ENTHUSIASM THAT FRANCIS HAS BROUGHT AND HIS COMMITMENT TO ADDRESS HOW THE NIH CAN PARTNER AND CREATE A PROJECT THAT CAN ACCELERATE DISCOVERY. NOW, WHAT I'M GOING TO START TO SHOW, THE GEOGRAPHICAL MAP FROM 1999 TO 2015, IDENTIFYING THE SIGNIFICANT INCREASES IN FATALITIES ASSOCIATED WITH OPIOID EPIDEMIC. THAT OF COURSE HAS GAL GALVANIZED THE COUNTRY LEADING TO RECOGNITION THE WAY WE ARE ADDRESSING PAIN IS ACTUALLY HAVING A VERY NEGATIVE EFFECT. UNFORTUNATELY, AS IT HAPPENS FREQUENTLY WITH ANYTHING THAT RESULTS IN A CRISIS, YOU RAPIDLY BECOME POLARIZED. ONE OF THE ISSUES THAT HAS HAPPENED AS A CONSEQUENCE OF THESE OPIOID CRISIS HAS BEEN THE QUESTIONING OF THE VALUE OF OPIOID MEDICATIONS FOR THE MANAGEMENT OF PAIN. WHILE EFFECTIVELY THE DATA SEEMS TO SUGGEST THAT IN GENERAL WHEN YOU REPEATEDLY ADMINISTER AN OPIOID, AS IT'S THE CASE FOR CHRONIC PAIN CONDITION, YOU RAPIDLY BECOME TOLERANT, NONETHELESS EVIDENCE FOR CERTAIN PATIENTS OPIOIDS MAY BE ONLY ONE OF THE FEW ALTERNATIVES. WHAT IT DOES HIGHLIGHT IN MY VIEW THE OPIOID CRISIS, I COME FROM THE NATIONAL INSTITUTE ON DRUG ABUSE SO I'M SEEING IT FROM THE PERSPECTIVE OF THE OPIOID ADDICTION YET AT THE SAME TIME RECOGNIZE IF WE DO NOT ADDRESS THE TREMENDOUS NEED THAT THERE IS FOR PATIENTS SUFFERING FROM PARTICULARLY CHRONIC PAIN AS WELL AS CHANGING OUR PRACTICES ABOUT HOW WE PRESCRIBE OPIOIDS FOR ACUTE PAIN CONDITIONS, WE'RE NOT GOING TO BE SO ABLE TO SOLVE THIS CRISIS. NOW, WHAT IS THE ESSENCE OF ISSUE WITH OPIOIDS? THIS IS ILLUSTRATED WITH DIFFERENT TYPE OF MAP. THIS IS A MAP OF THE RECEPTOR CONCENTRATION WITH C1 1 CARFENTANIL AND POSITRON EMISSION THERAPY. OPIOID RECEPTORS IN THE HUMAN BRAIN, AND OPIOID RECEPTORS ARE TARGET FOR MEDICATIONS WE USE FOR TREATMENT OF PAIN. THERE ARE MANY VARIETIES AND THEY DIFFER IN TERMS OF PHARMACOKINETICS, BIOAVAILABILITY AND SPECIFICITY FOR BINDING AS OPPOSED TO THE OTHER TWO TIMES OF OPIOID RECEPTORS. WHAT RAPIDLY EMERGES IS JUST BY LOOKING AT THIS IMAGE IT SPEAKS BY ITSELF YOU CAN START TO UNDERSTAND WHY THESE MEDICATIONS ARE SO EXTRAORDINARY EFFECTIVE IN ADDRESSING AND MITIGATING PAIN, BECAUSE THEY BASICALLY ARE INHIBITORY TO SIGNALING IN THE BRAIN OF THE NETWORK THAT IS ACTUALLY RESPONSE FOR PROCESSING PAIN. THAT RELATES TO IMAGE THAT ALLOWS FILTERING OF SIGNAL AS IT'S HAPPENING IN THE THALAMUS AND REGIONS THAT RESPOND TO COGNITIVE SUCH AS CINGULATE GYRUS AND AMYGDALA. THERE'S A HIGH CONCENTRATION OF NEW OPIOID RECEPTORS IN THE NUCLEUS ACCUMBENS, INCLUDING THE OPIOID AGONIST DRUGS, ALL OF THEM HAVE THE POTENTIAL OF PRODUCING ADDICTION. IT'S VERY UNFORTUNATE. WHAT IS ALSO UNCLEAR AS WE KNOW MORE ABOUT THE NEUROBIOLOGY IS EXTENT WE CAN GET AWAY WITH THIS EEXTENT, THE ACTIVATION SYSTEM IS PART OF THE ANALGESIC THERAPEUTIC EFFECT IN ADDICTION TO EFFECTIVENESS. IF THAT WERE THE CASE IT'S GOING TO QUESTION VERY MUCH WHAT HAS ELUDED US UNTIL NOW, DEVELOPMENT OF ALTERNATIVE OPIOID AGONISTS THAT DO NOT HAVE REWIRING AND ADDICTIVE POTENTIAL, ONE OF THE GREATEST CHALLENGES OF ALL. WHAT WAS THE RESULT OF THE OPIOID CRISIS? IT WAS AN OVERPRESCRIPTION OF OPIOID MEDICATIONS SO WE WENT FROM 76 MILLION IN 1991 TO 290 MILLION FOR THE PRESCRIPTION OF -- THIS IS JUST REPRESENTED FOR PRESCRIPTION OF OXYCODONE AND HYDROCODONE, MOST FREQUENTLY PRESCRIBED OPIOIDS. THIS REFLECTED OUR REACTION TO THE VERY NEGATIVE ATTITUDE THAT WE HAD TAKEN AS A CULTURE REGARDING THE PRESCRIPTION OF OPIOIDS AND THE FEAR THAT WE HAD THEY WILL PRODUCE ADDICTION EVEN WHEN ADMINISTERED FOR ACUTE MANAGEMENT OF PAIN. IT WENT COMPLETELY IN THE OPPOSITE DIRECTION WHEN IT STARTED TO ACTUALLY BE PUSHED AS BASICALLY THE SENSE THAT IF IN THE CONTEXT IF YOU HAVE PAIN YOU WILL NOT BECOME ADDICTED LED PHYSICIANS TO PROPOSE INCREASING DOSES WITHOUT FEAR A PERSON WITH PAIN WILL BECOME ADDICTED BUT INCREASING DOSE LIAR WITH THE NOTION IF YOU BECOME TOLERANT YOU WILL NOT BE AT RISK FOR OVERDOSING WITH YOUR OPIOID MEDICATION. UNFORTUNATELY, THESE TWO BELIEFS WERE NOT CORRECT AND WE'RE FINDING PATIENTS THAT ARE BEING TREATED WITH OPIOID MEDICATIONS ARE ACTUALLY BECOMING ADDICTED. WE DON'T KNOW WHAT PERCENTAGE IT IS. WE ACTUALLY ESTIMATE THAT IT IS PROBABLY BETWEEN 6 AND 8%. THE REASON WHY THE NUMBERS VARY, YOU CAN READ ARTICLES THAT SAY 24, 30%, THOSE ARE ARTICLES CONFUSING BECOMING PHYSICALLY DEPENDENT WHICH IS SOMETHING THAT HAPPENS BASICALLY TO ALL OF US IF WE'RE REPEATEDLY ADMINISTERED OPIOIDS THAT ADDICTION, A PROCESS THAT TAKES MUCH LONGER THAT DEVELOP, MUCH LESS PREVALENT. IT IS BETWEEN 6 AND 8%, SO NONETHELESS BECAUSE OF THE LARGE NUMBER OF INDIVIDUALS THAT ARE PRESCRIBED OPIOIDS THAT IS NOT A NEGLIGIBLE AMOUNT. PATIENTS THAT ARE GIVEN VERY, VERY HIGH DOSES OF OPIOID MEDICATIONS, PARTICULARLY NOTABLE WHEN YOU START TO GET OVER 100 MILLIGRAMS OF MORPHINE EQUIVALENT ARE AT SIGNIFICANTLY HIGHER RISK OF OVERDOSE. WE DON'T UNDERSTAND WHY A PATIENT MIGHT BE STABLE AND THEN OVERDOSE, WE'VE SEEN FOR INDIVIDUALS TAKING VERY HIGH DOSES, ABUSING HAD ABUSING HEROIN, STABLE AND THEN ONE DAY OVERDOSING. WE'RE ALL AWARE, WE'RE ALSO AWARE THAT DESPITE THIS INCREASE IN OPIOID PRESCRIPTION AS FRANCIS SAID BASED ON GOOD INTENTION TO GIVE TREATMENT FOR THOSE SUFFERING FROM PAIN, ALSO DID NOT MEAN, THE FACT THAT YOU'RE OVERPRESCRIBING THAT YOU WERE PROPERLY TAKING CARE OF PATIENTS. THERE IS NO EVIDENCE THAT THE INCREASES THAT WE OBSERVE ARE GOING IN PARALLEL WITH INCREASE IN IMPROVEMENT IN THE OUTCOMES OF PATIENTS PARTICULARLY SUFFERING FROM CHRONIC PAIN FOR WHICH CLEARLY THERE IS AN ENORMOUS NEED OF MUCH GREATER TYPE OF INVESTMENT TO COME AT FROM GOVERNMENT AS WELL AS PUBLIC/PRIVATE -- PRIVATE INDUSTRY TO DEVELOP BETTER ALTERNATIVES FOR TREATMENT. CHANGES IN THIS INSURANCE SYSTEM TO ENSURE THAT THESE PATIENTS AT LEAST ARE GIVEN THE EVIDENCE-BASED TREATMENT. BECAUSE OF THESE THERE'S BEEN A STRONG CAMPAIGN TOWARDS INCREASING AMOUNT OF OPIOIDS BEING PRESCRIBED FOR MANAGEMENT OF PAIN. INDEED SINCE 2010 THERE HAS BEEN A SIGNIFICANT DECREASE IN THE NUMBER OF PRESCRIPTION AND IN THIS CASE WHAT YOU'RE SEEING IS MORPHINE MILLIGRAM EQUIVALENCE, PRACTICES LED TO EXPECTATION THESE WOULD FINALLY LEAD TO A DECREASE, LEVELING OFF OF OVERDOSES AND FATALITIES FROM OPIOIDS. UNFORTUNATELY, THAT HAS NOT BEEN THE CASE. AND THIS IS THE ESTIMATED DATA BASED ON CDC OF WHAT THE OVERDOSE THAT WILL BE FOR 2016, IT'S NOT OFFICIAL SINCE NOT ALL OF THE STATES HAVE RETURNED THEIR STATISTICS BUT BASED ON THESE ANALYSIS WHICH WAS PUBLISHED ON SEPTEMBER 2 AT THE "NEW YORK TIMES" ESTIMATED 64,000 PEOPLE DIED IN 2016 AND GOING UP, WE HAVE NOT BEEN ABLE TO MOVE IT AROUND REGARDLESS OF INTERVENTION. I WANT YOU TO NOTE HOW BAD IT IS. THIS IS THE PEAK NUMBER OF FATALITIES ASSOCIATED WITH HIV DEATHS IN 1995, AT THE PEAK OF THE HIV UP 'EM EPIDEMIC, AND WE HAVE MASSIVELY SURFACED THAT, GALVANIZING THE COUNTRY TO REALIZE WE NEED TO DO MUCH MORE TO PREVENT AND REVERSE THIS CRISIS. WHAT IS DRIVING, I THINK IT IS EXTREMELY IMPORTANT. AS WE MAKE THESE DISCUSSIONS AND COME UP WITH SOLUTIONS NEED TO UNDERSTAND WHAT IS DRIVING THE OVERDOSES AND FATALITIES. I ALSO WOULD PUT FORWARD THAT THIS IS SOMETHING THAT ILLUMINATES DYNAMICS BUT THERE'S MORE WE NEED TO KNOW IN TERMS OF DEPLOYING SOME SOLUTIONS. FOR EXAMPLE, THIS IS THE CDC DATA WHERE THEY STARTED TO LOOK AT CONSEQUENCES OF FATALITIES AS FUNCTION OF THE DIFFERENT TYPE OF OPIOIDS ASSOCIATED WITH FATALITIES. THIS IS WHAT INITIATED PRESCRIPTION OPIOIDS AND WE SEE THATTER THERE CONTINUING TO INCREASE. WHEN THEY STARTED TO DIVIDE IT IN TERMS OF ALSO THE HEROIN AS OPPOSED TO PRESCRIPTION OPIOIDS YOU SEE AS OF RECENTLY 2010 HEROIN CONTRIBUTED TO APPROXIMATELY 2,000 FATALITIES, FOR MANY YEARS. AND THEN IT ROSE VERY, VERY PRECIPITOUSLY. THIS IS RISE REFLECTS TWO PHENOMENA, ONE IS AS PEOPLE THAT BECAME ADDICTED TO PRESCRIPTION OPIOIDS FOUND IT ACTUALLY HARDER TO GET MEDICATIONS, SHOULDN'T CALL THEM MEDICATIONS SOME WERE TO GET THE DRUGS IN THE BLACK MARKET, THEY SHIFTED TO HEROIN BECAUSE IT WAS MUCH MORE ACCESSIBLE AND MUCH LESS EXPENSIVE. THE OTHER FACTOR THAT CONTRIBUTED TO THE VERY SIGNIFICANT INCREASE IN HEROIN OVERDOSE, HEROIN, THE AMOUNT OF HEROIN THAT CAME INTO THE COUNTRY WAS DRAMATICALLY INCREASED, DELIVERED FROM AFGHANISTAN, PRODUCED IN MEXICO, HIGH PURITY, ACCESSIBLE AND FLOODED THE UNITED STATES. THAT FACILITATED PURITY, HIGHER RISK, FLOODING OF THE UNITED STATES MARKET WITH HEROIN MADE IT SO MUCH MORE EASIER. IN THE PROCESS ANOTHER PHENOMENA HAPPENED WHICH WAS THAT IN 2013 MORE OR LESS WE SEE THIS BLUE DROP, WHICH IS SOMETHING WE HAVE NEVER SEEN IN THE UNITED STATES, THERE HAS BEEN A SERIES OF CASES OF FENTANYL OVERDOSE AT THE BEGIN OF 2000s, WHEN THEY CLOSED THE SYNTHETIC LABORATORY, AND WE SEE THE STEEP INCREASE, FENTANYL COMING FROM CHINA, IT'S ACTUALLY USED TO LACE HEROIN AND ALSO LACE PRESCRIPTION OPIOIDS. FENTANYL HAS 50 TIMES HIGHER POTENCY THAN HEROIN AND AT THE RISK OF FATALITIES IS MUCH MUCH HIGHER. THERE ARE OTHER SYNTHETIC ANALOGS, FRANCIS MENTIONED CARFENTANIL. WHEN YOU PLAY WITH SYNTHETIC DRUG RISK OF OVERDOSS JUMPS HIGHER BECAUSE IT'S TO START WITH VERY DIFFICULT TO QUANTIFY PROPERLY WHAT DOSES A PERSON SHOULD TAKE. THESE ARE THE CHALLENGES WE'RE FACING NOW. PEOPLE THAT HAVE BECOME ADDICTED TO PRESCRIPTION OPIOIDS, 6 TO 8% TRANSITIONING TO HEROIN, DOESN'T SOUND MUCH, IF YOU THINK ABOUT IT WE'RE PRESCRIBING ENORMOUS NUMBERS OF PRESCRIPTION OPIOIDS, THAT TURNS OUT TO BE 80% OF THE NEW CASES OF HEROIN ABUSE, BASICALLY WERE PATIENTS THAT BECAME -- I SHOULDN'T CALL THEM PATIENTS, THAT'S ANOTHER MISTAKE WE'RE MAKING IS MANY OF THOSE INDIVIDUALS INITIATED PRESCRIPTION OPIOID FOR THEIR ABUSE POTENTIAL AND REWARDING EFFECTS, NOT NECESSARILY PATIENTS THAT HAD PAIN. IN FACT ONE OF THE THINGS WE DON'T KNOW YET IS WHAT PERCENT OF DOSING INDIVIDUALS TRANSITIONED TO HEROIN INITIATED ON PRESCRIPTION OPIOIDS FOR PAIN, WE KNOW IT'S NOT NEGLIGIBLE BUT DON'T KNOW WHAT PERCENTAGE IT IS. THEY ACTUALLY BECOME ADDICTED TO HEROIN AND BECOME TOLERANT TO HEROIN, SOME OF THEM ARE ACTIVELY SEEKING FOR MORE POTENT SYNTHETIC DRUGS. THIS IS WHERE WE ARE NOW AND WHAT WE NEED TO SOLVE. SO FRANCIS PRESENTED THE SLIDE THAT HAS BEEN SHOWING FOR SEVERAL YEARS, A TRIANGLE. A PURPOSE A TRIANGLE IN WHICH I'M PUTTING AT THE TOP THE NEED TO ADDRESS PAIN MANAGEMENT BECAUSE THIS IS DRIVING -- THIS IS WHAT TRIGGERED THE PHENOMENA EVEN IF NOT PATIENTS THAT HAD PAIN THAT THEN BECAME ADDICTED, THE FACT WE WERE OVERPRESCRIBING MEDICATIONS FOR ACUTE OR CHRONIC MANAGEMENT MUCH PAIN FACILITATED THEIR DIVERSION, WENT INTO THE BLACK MARKET AND THEN PEOPLE STARTED TO ABUSE. WE NEED TO ADDRESS PATIENTS WITH PAIN ARE NOT GOING TO GO AWAY AND AS FRANCIS SAID 25 MILLION AMERICANS ARE SUFFERING FROM IT. IT'S ONE OF THE MOST DEVASTATING CONDITIONS WHEN IT IS NOT TREATED. SO IT'S NOT -- THAT'S WHY IT'S NOT ACCEPTABLE UNDER ANY CONDITIONS TO SAY, OKAY, THERE'S NOT GOING TO BE ANY MORE OPIOID MEDICATIONS, ALL ALONG, WITHOUT PROVIDING ALTERNATIVES. SO I ALSO WELCOME THE COMMENT WE NEED TO ALSO FIGURE OUT THE WAY IN WHICH WE CAN GENERATE MODELS FOR INTEGRATIVE CARE OF PAIN FOR WHICH YOU GET REIMBURSEMENT BECAUSE THAT'S THE OTHER PART AND MAJOR CHALLENGE. ON THE BASIS OF THIS PYRAMID WE HAVE ISSUES THAT RELATE SPECIFICALLY TO HOW CAN SCIENCE ADVANCE OPIOID ADDICTION TREATMENT AND HOW CAN SCIENCE ADVANCE PREVENTION OF OVERDOSES AND OVERDOSE REVERSAL AND THIS IS WHERE UNIQUE OPPORTUNITIES COME WITH PUBLIC/PRIVATE PARTNERSHIP. WHAT DO WE HAVE IN THE SPACE OF TREATING INDIVIDUALS WITH OPIOID USE DISORDERS? METHADONE IS A FULL AGONIST, IT REQUIRES DAILY ADMINISTRATION. IT'S USUALLY TYPICALLY ACHIEVED IN A METHADONE CLINIC. YOU CANNOT GO TO YOUR PHYSICIAN PROVIDER AND HE CANNOT PRESCRIBE METHADONE. YOU HAVE TO GO TO A CLINIC, IN MANY INSTANCES PATIENTS HAVE TO TRAVEL ONE OR TWO HOURS, PLACES IT'S NOT EASILY AVAILABLE MAKING IT HARD FOR A PERSON TRYING TO RECOVER TO MAKE THE DECISION ON A DAILY BASIS TO GO TO THE METHADONE CLINIC WHILE TRYING TO KEEP A JOB. I THINK THAT IS PRACTICALLY QUITE UNREALISTIC. WE HAVE BUPRENORPHINE. BECAUSE IT'S A PARTIAL AGONIST, IT MAY NOT BE SUFFICIENT TO PREVENT WITHDRAWAL. FINALLY FRANCIS MENTIONED THIS, THERE IS AN ANTAGONIST EXTENDED RELEASE, NALTREXONE, NAMED VIVITROL, DEVELOPED IN PARTNERSHIP WITH NIDA. THIS MEDICATION IS ONE MORE MEDICATION WHICH IS WONDERFUL, YOU DON'T NEED TO BE GOING ON A DAILY OR TWICE OR THREE TIMES A WEEK. ALL OF THESE MEDICATIONS REGARDLESS DO EVERYTHING THEY ARE SUPPOSED TO DO. DECREASE OPIOID USE, DECREASE OVERDOSE DEATHS. THAT HAS BEEN SHOWN BY INDEPENDENT STUDIES, I'LL SHOW YOU DATA. DECREASE CRIMINAL ACTIVITY, DISEASE TRANSMISSION, HIV, HEPATITIS C TRANSITION, VERY IMPORTANT SECONDARY NEGATIVE EFFECT OF THE OPIOID CRISIS. THEN IT INCREASES SOCIAL FUNCTIONING, RETENTION AND TREATMENT, IMPROVEMENT ON OUTCOMES FOR INDIVIDUALS FOR BABIES BORN WITH NEONATAL SYNDROME. DESPITE ALL OF THESE POSITIVE AND PRETTY LARGE EFFECTS FOR MANY OF THEM, THEY ARE MASSIVELY UNDERUTILIZED. STILL WHEN THEY IMPROVE SIGNIFICANTLY OVER TREATMENT AS USUAL WITH NO MEDICATION, THE RELAPSE RATE IS HIGH WHICH REFLECTS DIFFICULTY OF SOME RETAINING COMPLIANCE WITH MEDICATIONS. HERE INDICATING OPPORTUNITY TO IMPROVE ON THESE TREATMENTS. HOW BAD IS THIS SITUATION OF UNDERUTILIZED? I PRESENT LIKE THE CASCADE INITIALLY METRIC DEVELOPED FOR HIV. FOR THE OPIOID USE DISORDER JUST TO SEE HOW BAD WE ARE, SO IN BLUE IS WHERE WE ARE. APPROXIMATELY, SAY, AWAY HE KNOW 2.5 MILLION PEOPLE ARE ADDICTED TO OPIOIDS, AND PROGRAMS 1.5 ON DIAGNOSED, WE ENGAGE IN CARE, 600,000 AND SEE NUMBERS DRAMATICALLY REDUCING THOSE INITIATED ON MEDICATION ASSISTED TREATMENT, 300,000. HOW MANY ARE RETAINED IN SIX-MONTH TREATMENT OR YOU'RE GOING TO RELAPSE, AND MAINTAINING CONTINUOUS ABSTINENCE LESS THAN 2%. WHAT WE FACED MORE IMMEDIATE SOLUTIONS LOWER-HANGENING FRUIT IS DEVELOP ALTERNATIVE FORMULATIONS OF MEDICATIONS THAT HAVE BEEN SHOWN TO BE EFFECTIVE AND THIS IS THE NALTREXONE, VIVITROL AND ONE-MONTH FORMULATION OF NALTREXONE, ANOTHER MEDICATION, SIX-MONTH BUPRENORPHINE MEDICATION THAT DELIVERS EQUIVALENT AMOUNT, THOSE ACHIEVED WITH EQUIVALENT DOSE FOR SIX MONTHS OF BUPRENORPHINE. THE ONLY PROBLEM IS IT IS THE EQUIVALENT OF 8 MILLIGRAMS OF BUPRENORPHINE, A RELATIVELY DIFFERENTLY LOW DOSE. THERE IS AN INTEREST FOR EXTENDED RELEASE BUPRENORPHINE THAT CAN ACHIEVE LEVELS EQUIVALENT TO THOSE OF 16 MILLIGRAMS OR 22 MILLIGRAMS AND SIMILARLY ENORMOUS AMOUNT OF INTEREST TO EXTEND THE FORMULATIONS FOR ONE TO TWO MONTHS, IDEALLY SIX MONTHS. THOSE ARE SOME CHALLENGES WE WOULD LIKE TO UNCOVER WITH THE PUBLIC/PRIVATE PARTNERSHIP. IN THE MEANTIME WE'RE ARE ACTUALLY WORKING WITH THESE COMPANIES AND ACADEMIC CENTERS TO DEPLOY SERVICES AND IMPLEMENTATION RESEARCH TO DEVELOP MODELS THAT CAN TAKE ADVANTAGE OF THESE NEW FORMULATIONS IN THE HEALTH CARE HEALTH CARE SYSTEM, WE'RE OPTIMIZING THIS PRIORITY. WHILE THIS STUDY WAS DONE, ON EMERGENCY DEPARTMENTS, WITH SUBLINGUAL BUPRENORPHINE, IT WAS INITIATED WHEN YOU ENDED UP IN THE EMERGENCY DEPARTMENT, AT 30 DAYS THE USE OF HEROIN WAS MUCH& LOWER THAN WHEN YOU ACTUALLY SEND THEM TO RESEVERAL TO TREATMENT OR DID A BRIEF INTERVENTION. HIGHLIGHTING A VERY SIMPLE INTERVENTION ON THE EMERGENCY DEPARTMENT, DECREASED UTILIZATION OF EMERGENCY DEPARTMENTS WHEN YOU INITIATED. IT IS EXPECTED AND WE'RE ALL HOPING IT WILL HAPPEN RELATIVELY SOON IN THE NEXT YEAR WE MAY HAVE TWO NEW FORMULATIONS OF BUPRENORPHINE THAT WILL HAVE AT LEAST ONE OF THEM ONE MONTH DURATION AND THE OTHER ONE, TWO OTHER ONES THAT WILL EXTEND, ONE FOR ONE WEEK, TWO FOR ONE MONTH WHICH WILL MAKE IT EASIER FOR PHYSICIANS IN THE EMERGENCY PHYSICIANS OR PHYSICIANS THAT ARE ACTUALLY SPECIALIZING IN PAIN TO ALSO ACTIVELY ENGAGE IN THE TREATMENT OF THE OPIOID USE DISORDER. WE'RE ALSO DEVELOPING ALTERNATIVE MODELS THAT WILL ALLOW PATIENTS TO TAKE BUPRENORPHINE HOME ON A 30 OR 60 OR 90 DAY BASIS WITH MINIMIZING AND PROTECTING THEM FROM DIVERTING AND FOR THEM TO ENCOURAGE THEM TO PROPERLY TAKE MEDICATIONS AND THIS IS AN EXAMPLE WHERE THEY ACTUALLY WERE VERY, VERY SUCCESSFUL IN RETAINING PATIENTS IN ABSTINENCE FOR 12 WEEKS BY SENDING THEM HOME WITH BUPRENORPHINE DELIVERY SYSTEM THAT DID NOT PREVENT TAMPERING WITH IT. YOU SEE THE PARTNERSHIP, THE NO BUPRENORPHINE, THOSE THAT REMAINED IN ABSTINENCE BASICALLY ZERO VERSUS THE HOME DELIVERY SYSTEM. INCREDIBLE, THESE ARE RELATIVELY SIMPLE DEVICES THAT COULD BE ACTUALLY MADE AVAILABLE RELATIVELY RAPIDLY THAT COULD HELP COVER FOR THE LACK OF INFRASTRUCTURE IN CERTAIN PLACES, FOR DELIVERY OF THESE MEDICATIONS. THIS IS ANOTHER EXAMPLE JUST TO ILLUSTRATE VIVITROL WAS DONE IN PRISONERS, INDIVIDUALS THAT WERE GIVEN TREATMENT AS USUAL, RELAPSE FREQUENCE AND PLACED ON EXTENDED RELEASE NALTREXONE. NOTABLE, LOOK AT OVERDOSES IN WEEKS, HIGHLIGHTING THE NOTION THAT THESE MEDICATIONS COULD HELP PREVENT OVERDOSES. IN THE TERMS OF RESEARCH AND ONE OF THE THINGS THAT WE HAVE ACTUALLY AS WE'RE DISCUSSING WITH PUBLIC/PRIVATE PARTNERSHIP WE'VE BEEN DISCUSSING NOTION OF DEVELOPING EXTENDED RELEASE FORMULATIONS OR DRUG COMBINATIONS FOR TREATMENT OF OPIOID USE DISORDER OR TO ACTUALLY REPURPOSE MEDICATIONS FOR THE USE OF OPIOID USE DISORDER FOR WHICH PHARMACEUTICALS MAY HAVE COMPOUNDS FOR WHICH ACTUAL APPROVAL MAY BE EASIER BECAUSE THERE'S CLINICAL AND TOXICITY DATA. IN PARALLEL WE HAVE BEEN WORKING AS PART OF THE BASIC SCIENCE TO CHARACTERIZE NEUROCIRCUITRY AND NEUROTRANSMITTERS AND MODULATORS ASSOCIATED AND CHANGED BY THE EXPOSURE TO DRUGS. AND USING THEM TO DEVELOP PHENOTYPES THAT CAN BE TARGETED AS OPPOSED TO TRYING TO COME UP WITH MEDICATION THAT WILL TAKE CARE OF EVERYTHING DISRUPTED BY ADDICTION. IF YOU WERE TO DEVELOP MEDICATIONS THAT WILL REDUCE STRESS INDUCED, YOU COULD HAVE A MEDICATION THAT WOULD BE USEFUL FOR POSTTRAUMATIC STRESS DISORDER, TO ARE DEPRESSION AND MAY EVEN HAVE VALUE FOR TREATMENT OF PAIN. SO THE TARGETING ENDOPHENOTYPE EXPANDS THE OPPORTUNITY OF HAVING MORE THAN ONE INDICATION FOR AN INTERVENTION. FRANCIS MENTIONED WE'VE BEEN FUNDING, THIS IS AN AREA FOR WHICH THERE IS NOT MUCH INTEREST AS OF NOW FOR PHARMA, SOME PHARMA ARE INTERESTED ON GETTING THE LICENSING FOR SOME OF THE VACCINES WE'VE HELPED DEVELOP, SPECIFICALLY FOR HEROIN AND THERE IS AN INVESTIGATOR AT THE SCRIPPS INSTITUTE THAT IS DEVELOPING VACCINE AND ANTIBODIES FOR FENTANYL BECAUSE THIS IS ONE OF THE MOST CHALLENGING ISSUES AS RELATES TO PREVENTING OVERDOSES. THIS IS WHAT LED TO THE PUBLIC/PRIVATE PARTNERSHIP THAT FRANCIS WAS DISCUSSING AND THIS IS WHERE WE ARE SPECIFICALLY WITH A LIST OF PROJECTS, 33 COMPANIES HAVE PARTICIPATED TO GET A SENSE OF WHAT THEIR INTERESTS MAY BE. THERE IS INTEREST, I WOULD SORT OF SAY FOR ALL OF THE 33 COMPANIES BASICALLY MOST OF THEM HAVE EXPRESSED SIGNIFICANT INTERESTS FOR THE PROJECTS THAT WILL BE DELINEATED BY WALTER AS IT RELATES TO ADVANCING PAIN MEDICATIONS, NEUROBIOLOGY OF PAIN. THERE IS MUCH LESS INTEREST ON THE DEVELOPMENT OF MEDICATIONS FOR OPIOID USE DISORDERS BECAUSE IN GENERAL BIG PHARMA HAS NOT PARTICIPATED IN THIS SPACE. ONE OF THE ASPECTS WE WERE HOPING TO ACHIEVE AS PART OF THE PUBLIC/PRIVATE PARTNERSHIP IS TO BE ABLE TO ENGAGE THEM BECAUSE THEIR PARTICIPATION ON THE BASIS OF THEIR SCIENTIFIC EXPERTISE AND EXTRAORDINARY RESOURCES WILL ACCELERATE OUR ABILITY TO DEPLOY MEDICATIONS THAT MAY BE ABLE TO FOR EXAMPLE TREAT INDIVIDUALS THAT SUFFER FROM AN OPIOID USE DISORDER IN WAYS THAT ARE MOST EFFECTIVE BUT ALSO IMPORTANTLY DO INTERVENTIONS THAT MAY PREVENT PATIENTS BEING TREATED WITH OPIOID MEDICATIONS TO DEVELOP ADDICTION. WE ALSO ARE INTERESTED IN OF COURSE IN SOME BASIC JUST LIKE WE WILL BE HEARING FROM WALTER, SOME OF THE BASIC SCIENCE, WHETHER THE PUBLIC/PRIVATE PARTNERSHIP COULD BE UTILIZED TO DEVELOP RESEARCH NETWORK THAT WOULD ALLOW US AS PART OF DOING PROSPECTIVE STUDIES ON PATIENTS TREATED WITH OPIOID MEDICATIONS WHICH WILL BE DEVELOPING AN OPIOID USE DISORDERS AND CAN WE ACHIEVE BIOMARKERS TO HELP PREDICT WHEN THIS IS THE CASE. AND THIS IS MY LAST SLIDE, IT SHOWS WHAT HAS NIDA BEEN DOING. WE HAVE BEEN PARTNERING FOR MORE THAN 20 YEARS WITH PHARMACEUTICAL INDUSTRY TO RISK COMPOUNDS BECAUSE PHARMACEUTICAL INDUSTRY OTHERWISE WOULD HAVE NOT GONE INTO THE SPACE. WE'VE GENERATED GRAND MECHANISMS THAT ARE SPECIFICALLY TARGETED TO ACTUALLY CREATE AN INTERACTION BETWEEN AN ACADEMICIAN AND PHARMACEUTICAL TO CONDUCT STUDIES TO DEVELOP ANSWERS RELATIVELY RAPIDLY SO THE TWO MECHANISMS, GRANT OPPORTUNITY AND STRATEGIC ALLIANCE, ACTUALLY GIVE MONEY OVER THREE YEARS BUT A SIGNIFICANT AMOUNT UP TO $5 MILLION PER YEAR IN ORDER TO GET GO-NO GO DECISIONS FASTER THAN WE WOULD OTHERWISE BE DOING IT. WE HAVE A NIDA TRANSLATIONAL AVANT-GARDE AWARD TO ENCOURAGE RESEARCHERS WITH HIGH RISK INTERVENTION THAT COULD HAVE HIGH PAYOFF AND ALSO HAVE A VERY ACTIVE SBIR AND STTR PROGRAM AT NIDA THAT IS PRIORITIZING MEDICATION DEVELOPMENT WHETHER IT IS FOR SUBSTANCE USE DISORDERS OR WHETHER IT IS FOR THE DEVELOPMENT OF PAIN MEDICATION THAT ARE NON-ADDICTIVE. AND THEN WE HAVE CONTRACTS THAT ACTUALLY FOR WHICH WE PROVIDE CONFIDENTIAL WORK THAT RELATES -- THAT COULD HELP PHARMACEUTICAL DEVELOP THEIR PRODUCT INCLUDING INVESTIGATING A PARTICULAR FOR EXAMPLE ANALGESIC MEDICATION BEING DEVELOPED HAS REWARDING EFFECT IN ANIMAL MODELS AS WELL AS HUMANS. WITH THAT I WANT TO END MY PRESENTATION, I DO NOT KNOW IF THE QUESTIONS ARE NOW OR LATER, AND IF THEY ARE LATER I THEN WOULD LIKE TO -- WELL, WALTER DOES NOT NEED AN INTRODUCTION. >> OPEN FOR QUESTIONS FIRST. >> AN IMPRESSIVE AMOUNT OF WORK HAS GONE FORWARD. I'M WONDERING GIVEN THE SUM OF THE COMMON RULE MECHANISMS THAT MAY SURROUND OUD AND CHRONIC PAIN, HYPOTHETICAL BUT STILL VERY LIKELY, AND WHETHER IT'S WORTH CONSIDERING AGENTS LIKE BUPRENORPHINE NOT ONLY FOR OUD BUT TRIALS WITH CHRONIC PAIN AS WELL. AND OTHER MEDICATIONS WHERE THAT MAY TARGET COMMON NEUROMECHANISMS BETWEEN CHRONIC PAIN STATES AND OUD. AND RATHER THAN PUTTING THEM IN TWO SEPARATE BUCKETS MAYBE A VENN DIAGRAM WHERE WE BEGIN TO TRY TO IDENTIFY TARGETS THAT ARE SHARED IN COMMON AND THEN TO IDENTIFY AGENTS THAT WE CAN GO AFTER BOTH POTENTIALLY TOGETHER. >> YEAH, NO, I RESONATE WITH THAT RECOMMENDATION, AND I MEAN I THINK THAT YESTERDAY AT THE ANESTHESIOLOGY MEETING METHADONE PREVENTED USE OF OPIOIDS FOR SURGERY, THAT WAS JUST A CLINICAL STUDY NOT BASED ON ANY PRE-KNOWN MECHANISM THAT IS COMMON TO THE NEUROPLASTICITY ASSOCIATED WITH ADDICTION, THIS IS AN OPPORTUNITY THAT WE NEED TO ALSO RESHAPE OUR NARRATIVE AND I KNOW THAT SHARON IS RAISING HER HAND SO MAYBE SHE WANTED TO ALSO ADDRESS IT. >> THERE ARE ALREADY TWO PRODUCTS SHOWN EFFECTIVE IN CHRONIC PAIN TO BUPRENORPHINE PRODUCTS. THERE'S TRANSDERMAL SYSTEM AND A TRANSMUCOSAL. SO IT'S ALREADY BEEN DONE. >> YEAH, BUT THAT IS IN TERMS OF BUPRENORPHINE, AND THE EUROPEANS USE BUPRENORPHINE AS AN ANALGESIC. I THINK THE QUESTION ALSO GOES BEYOND THAT AS WE UNDERSTAND THE ADAPTATION, NEUROPLASTIC ADAPTATION LINKED WITH CONVERSION FROM ACUTE TO CHRONIC OR CONVERSION FROM ACTUALLY DRUG EXPERIMENTATION AND ADDICTION, THOSE TRANSITIONS, WHAT ARE THE NEUROPLASTIC CHANGE AND THERE'S SOME EVIDENCE SOME OF THEM MAY BE COMMON PLUS AS MENTIONED NEUROCIRCUITRY ACTUALLY HAS AN ENORMOUS AMOUNT OF OVERLAP WHICH GIVES US OPPORTUNITIES, THAT'S IN ITEMS OF NEUROCIRCUITRY AND ENDOPHENOTYPES THAT'S RELEVANT NOT JUST FOR ADDICTION BUT I THINK ALSO FOR THE NEUROBIOLOGY OF PAIN. BUT, YEAH, I THINK WE NEED TO EXPAND IT AND I WOULD HOPE THAT IN THIS PUBLIC/PRIVATE PARTNERSHIP THAT NARRATIVE ACTUALLY IS EMERGING, OTHERWISE IT'S EASIER TO JUST DIVIDE THEM BUT WE'RE MISSING AN OPPORTUNITY OF WHAT THE IMPETUS AND INERTIA WILL COME FROM BOTH OF THEM COMING TOGETHER. >> TWO QUESTIONS. DOES THE SPECIAL PLACE NEED TO BE CARVED OUT FOR PEOPLE WHO HAVE OPIOID USE DISORDER OR SUBSTANCE USE DISORDER, AND CHRONIC PAIN AT THE SAME TIME? BECAUSE TREATMENTS FOR EACH SEEM TO BE DIFFERENT. AND I'M WONDERING DOES THAT AREA ESPECIALLY WHEN PEOPLE ARE IN THE PUBLIC AREA TRYING TO GO THROUGH FOR INSTANCE DRUG COURT SYSTEMS. >> YEAH, I WOULD SAY AS A PSYCHIATRIST THAT'S PROBABLY ONE OF THE MOST CHALLENGING SITUATIONS WHERE YOU HAVE A PATIENT THAT HAS A SEVERE PAIN CONDITION AND HAS BECOME ADDICTED TO THEIR OPIOID MEDICATION AND DON'T RESPOND TO OTHER TREATMENTS SO WE'RE CONDUCTING A LARGE CLINICAL TRIAL TO SEE AND COMING BACK TO SHARON'S POINTs THE VALUE ON THOSE PATIENTS, WHETHER WE COULD MAINTAIN THEM ON BOTH FOR CONTROL THE CRAVING AND PREVENT THE WITHDRAWAL, AND AT THE SAME TIME MANAGE THEIR PAIN WITH BUPRENORPHINE, AND RESULTS WERE VERY POSITIVE. WHAT'S EVEN MORE ENCOURAGING, FRANCIS PUT THE BULLET POINT, HOW LONG DO WE NEED TO TREAT PATIENTS WITH OPIOID USE DISORDERS? IF YOU SPEAK WITH CLINICIANS WORKING ON THE FIELD FOR MANY YEARS MANY WOULD SAY SOME PATIENTS HAVE TO BE ON IT FOR LIFE. AND WE WERE INTERESTED TO ADDRESS THAT QUESTION, ON THAT PARTICULAR GROUP OF PATIENTS, BECAUSE IN GENERAL IF YOU HAVE A PAIN PATIENT THAT HAS BECOME ADDICTED TO THEIR OPIOIDS THEY TEND TO HAVE SHORTER HISTORIES AND THEY TEND TO USE LOWER AMOUNTS THAN ABUSERS CONSUMING FOR 20 OR 30 YEARS. THE STUDY SHOWED AT THREE YEARS 30% OF THOSE PATIENTS WERE ABLE TO BE TAPERED OFF BUPRENORPHINE AND DO VERY, VERY WELL. 30% SUSTAINED REMISSION ON BUPRENORPHINE. AND THE OTHERS WERE LOST TO THE FOLLOW-UP. WHICH ACTUALLY CONSIDERING THAT AT LEAST IN THIS POPULATION WE WERE ABLE TO SHOW POSITIVE RESULTS AND GOOD OUTCOMES IN 30s THEM 30% WHERE WE WERE ABLE TO TAPER OFF THE BUPRENORPHINE. THERE IS EVIDENCE CERTAINLY BUPRENORPHINE IS ONE OF THE TOOLS THAT CAN BE HELPFUL. >> THANK YOU. I LOOK FORWARD TO THE RECORDING OF THE SECOND STUDY. THE SECOND ONE IS WHEN I HEAR THE 25 MILLION PEOPLE IN PAIN DAILY, IS THIS THE HIGH IMPACT CHRONIC PAIN OR IS THERE A BIG DIFFERENCE BETWEEN THE 25 MILLION THAT NIDA RECOGNIZES AND THE 100 MILLION THAT ARE RECOGNIZED IN THE IOM REPORT? >> YEAH, NO, AND I'VE ACTUALLY ASKED MYSELF THAT QUESTION. I SORT OF SAID I NEED TO GO BANG TO THE IOM TO LOOK AT IT IN TERMS OF WERE THEY SPEAKING OF 100 MILLION ON DAILY PAIN, AND I DON'T THINK THEY WERE REFERRING TO IT BUT AS I SAY IT'S IN MY IN BOX OF MY BRAIN BUT I HAVEN'T ACTED UPON IT TO SEE IF IT IS. I THINK IT IS 100 MILLION AMERICANS, IF YOU ASKED THEM HAVE YOU SUFFERED PAIN IN A CERTAIN AMOUNT OF TIME, THAT'S WHERE I THINK. BUT AGAIN WE ALL -- I NEED TO CHECK. MAYBE WALTER OR LINDA KNOW THAT OR SOMEONE ELSE KNOWS BUT OTHERWISE WE'LL LOOK AT IT AND GET BACK TO YOU. >> NORA, YOU GOT IT RIGHT. THE 100 MILLION IS PEOPLE WHO HAVE HAD PAIN WITHIN THE LAST THREE MONTHS. 25 MILLION PEOPLE HAVE PAIN DAILY. AND HIGH IMPACT WHICH ACTUALLY INTERFERES WITH YOUR LIFE, YOU CAN'T GO TO SCHOOL, CAN'T GO TO WORK OR ANOTHER MEASURE, A SMALLER AMOUNT THAN THAT. I WANT THAT SAY THAT'S 2 MILLION-PLUS. AND THERE'S ANOTHER NUMBER IN THERE, EIGHT-SOMETHING MILLION, SEVERE DAILY PAIN. MOST OF THIS COMES OUT OF THE NAHAN SAT OF PAPERS, RICHARD NAHAN >> I'M WONDERING WHEN YOU TOOK THE PEOPLE LIVING WITH PAIN AND STARTED USING THE BUPRENORPHINE DID YOU GIVE THEM ANY OTHER PAIN MANAGEMENT MODALITIES OTHER THAN JUST FOCUS ON MEDICATION? BECAUSE I THINK THAT ONE MODEL OF JUST GIVING THE MEDICATION IS NOT GOING TO HELP A PERSON LIVE A FULL LIFE OF PAIN. AND IF YOU PROVIDED THEM WITH ALL THE OTHER COMPONENTS OF PAIN MANAGEMENT, AND THEN THE SELF MANAGEMENT, THEY MIGHT ACTUALLY BE ABLE TO TAPER OFF QUICKER AND ACTUALLY BE ABLE TO FUNCTION BETTER. I MEAN, IT'S A COMBINATION OF THERAPIES THAT HELP. >> IT IS ONE OF THE INSTANCES WHERE I ACTUALLY LOOK AT THE WE HAD THOUGHT OF THAT WHEN WE WERE DESIGNING THE TRIAL. SO WE DIDN'T. SO WE BASICALLY LEFT THE TREATMENT OF PAIN AS USUAL WITHOUT TRYING TO CONTROL IT WHICH WOULD HAVE ALLOWED US OF COURSE TO ADDRESS THE EXTENT TO WHICH IF YOU PROBABLY HAVING THE INTEGRATIVE PAIN MODEL IS IT EASIER THEN TO WEAN YOU OFF THE BUPRENORPHINE, AND WE DON'T HAVE THAT. I WOULD PUT FORWARD THE CONCEPT IN TERMS OF TREATMENT IN GENERAL OF THESE PATIENTS THAT YOU NEED AN INTEGRATIVE APPROACH AND BECAUSE THEY ARE SO SO VERY VULNERABLE, AND ANOTHER ASPECT THAT'S ALSO WE DON'T KNOW SUFFICIENT IS IN TERMS OF I SAY THE PATIENTS THAT OVERDOSE AND END UP IN THE EMERGENCY DEPARTMENT OR UNFORTUNATELY MAY DIE, WHAT PERCENTAGE OF THEM TO WERE GIVEN THE OPIOID FOR PAIN, WE KNOW IT'S NOT NEGLIGIBLE AND WE DON'T KNOW WHAT PERSONAL AND DON'T KNOW WHICH PERCENTAGE MAY BE ACTIVE SUICIDE ATTEMPT. WHICH IS THE OTHER SIDE THAT WE DON'T SPEAK VERY MUCH ABOUT, SEVERE PAIN, WHERE PATIENTS, THE RATE OF SUICIDE GOES UP. AND WITH COMORBIDITY OF DEPRESSION IS SO HIGH. I HIGHLIGHT IT BECAUSE WE NEED TO FACE THE FACT THAT IT'S INCREDIBLY DIFFICULT TO SUFFER, I MEAN DEVASTATING TO SUFFER FROM PAIN AND THAT WE NEED TO ADVANCE THIS WHOLE FIELD >> SO FIRST OF ALL THANK YOU SO MUCH FOR YOUR SENSITIVITY ABOUT THESE TWO VERY COMPLEX ISSUES. DRAWING ON WHAT JAN WAS SAYING, THE ISSUES OF PEOPLE WHO HAVE A SERIOUS ILLNESS, WHO HAVE EITHER PRIOR OR CURRENT SUBSTANCE USE DISORDER, WHO NOW NEED TREATMENT WITH OPIOIDS, THAT'S THE GROUP THAT I'M TREATING NOW. PEOPLE WHO HAVE SUBSTANCE USE DISORDER AND CANCER OR ANOTHER LIFE-THREATENING ILLNESS. WE HAVE NO DATA TO HELP GUIDE US IN THE CLINICAL SETTING SO THAT WOULD BE A WONDERFUL AREA OF INVESTIGATION AMONGST THE MANY LONG LIST OF THINGS THAT YOU'RE TRYING TO STUDY. THANK YOU. >> YEAH, I AGREE. WE DID THE CLINICAL TRIAL BUT OBVIOUSLY IT BEHOOVES IS, THE THIRD THAT FRANCIS HAD IS PUBLIC/PRIVATE PARTNERSHIP, CLINICAL RESEARCH NETWORK THAT WOULD ALLOW US TO ADVANCE QUESTIONS LIKE THAT, WHAT IS DIVERSITY OF THAT POPULATION, ARE THERE DIFFERENCES BETWEEN MEN AND WOMEN? WOMEN ARE OVERPRESCRIBED OPIOIDS WHEN COMPARED WITH MALES, RATES OF FATALITIES HIGHER WITH MALES, EXCEPT FOR OPIOIDS WHERE RATE OF FATALITY AMONG 45 TO 64 IS AS HIGH FOR WOMEN AS MALES, NOT YOUR DEMOGRAPHICS OF ABUSE AND JUST YOU'RE TAKING IT BECAUSE OF REINFORCING. IT BEHOOVES US TO UNDERSTAND THAT AND THERE IS DATA TO SHOW FROM NEUROBIOLOGY THERE MAY BE SIGNIFICANT DIFFERENCES IN EXPRESSION PATTERNS FOR SOME OF THE -- FOR KAPPA RECEPTOR, OPIOID RECEPTOR SYSTEM BUT WITHOUT DOING RESEARCH WE'RE MISSING THE OPPORTUNITY OF DOING A PERSONALIZED INTERVENTION. >> JUST WANTED TO THANK YOU FOR YOUR COMMENTS RIGHT NOW AND YOUR OPENING COMMENTS THAT A CRISIS TENDS TO POLARIZE THE COMMUNITY BECAUSE THE WORK THAT YOU'VE PUBLISHED AND ALSO YOUR STATEMENTS NOW, THOSE OF YOUR CO-WORKERS, THEY ARE ALL IMMENSELY VALUABLE, AT THE STATE LEVEL. THE VOICE OF BALANCE IS IMMENSELY HELPFUL AND I WOULD URGE YOU TO CONTINUE TO DISPLAY THAT SENSITIVITY. WE KNOW PATIENTS WITH CHRONIC ILLNESS PARTICULARLY CHRONIC PAIN ARE VICTIMS OF STIGMATIZATION. SO IN THE POLITICIZED OR POLARIZED CLIMATE HAVING YOUR STATEMENTS IN A NUMBER OF PUBLISHED PLACES IS EXTREMELY HELPFUL SO THANK YOU. >> NO, THANKS TO YOU BECAUSE IT'S ULTIMATELY THAT UNDERSTANDING COMPLEXITY OF OPIOID CRISIS, DIFFERENT FROM OTHER SUBSTANCE USE EPIDEMICS WHICH NEVER HAVE REACHED THESE WHERE YOU SAY, WELL, IF WE GOT RID OF COCAINE EVEN THOUGH IT'S A LOCAL ANESTHETIC NO ONE WILL SUFFER. GET RID OF METHAMPHETAMINE, EVEN USED FOR TREATMENT OF ATTENTION DEFICIT DISORDER, NO ONE WILL SUFFER. THIS IS LIFE-SAVING WHEN USED PROPERLY. WE CAN IMPROVE TO OPTIMIZE THE PHARMACOLOGICAL BENEFITS OF OPIOID MEDICATIONS WHEN THEY ARE INDICATED AND NEEDED BUT ACTUALLY MINIMIZED THE UNTOWARD EFFECTS THAT CAN BE QUITE DEVASTATING. NOW I INTRODUCE WALTER KOROSHETZ, DIRECTOR OF NEUROLOGY INSTITUTE AND PAIN CONSORTIUM AND IPRCC AND PARTNER IN THE PUBLIC/PRIVATE PARTNERSHIP. HE'S THE LEFT BRAIN AND I'M THE RIGHT BRAIN. >> VERY GOOD. YOUR LEFT BRAIN WORKS BETTER THAN MY LEFT. OKAY. I'D LIKE TO GO THROUGH WHAT HAS COME UP AS POTENTIAL PLANS FOR THIS PUBLIC/PRIVATE PARTNERSHIP AND THEN MAYBE OPEN UP FOR DISCUSSION ON GETTING ADVICE ON HOW TO MOVE FORWARD. THE CAVEAT THAT FRANCIS BROUGHT OUT BECAUSE THIS IS ABOUT A PARTNERSHIP WITH PHARMACEUTICAL COMPANIES, YOU KNOW, IT'S A REALLY CONFINED SPACE IN TERMS OF PAIN. BUT I THINK WE ARE TRYING TO TAKE ADVANTAGE OF THESE OPPORTUNITIES THAT THE OPIOID CRISIS PRESENTS TO DEVELOP BETTER PAIN THERAPIES, BECAUSE THAT'S WHAT PATIENTS NEED AND ALSO IF WE CAN -- IF WE CAN TURN OPIOIDS INTO SOMETHING THAT'S NOT NECESSARY ANYMORE THEN WE COULD GET RID OF THE OPIOID CRISIS, ALTHOUGH THAT IS A MAGIC BULLET AS TRIPP SAID THAT MAY BE HARD TO ACHIEVE IN TOTALITY BUT WE DO HAVE OTHER NON-ADDICTIVE PAIN MEDICINES THAT IF YOU HAVE RIB FRACTURES, NONSTEROIDALS WORK GREAT. WHEN THEY WEAR OFF, IT HURTS. SO CAN WE GET MORE EFFECTIVE NON-ADDICTIVE MEDICINES, THAT'S WHERE THE INTEREST OF THE PHARMACEUTICAL COMPANIES WOULD BE AND THAT'S KIND OF THE SPACE WE'RE OPERATING IN. AND THERE'S A LOT THAT COULD POTENTIALLY BRING THEM INTO THE SPACE BECAUSE AS WE ALL KNOW PAIN IS SO COMMON BUT WE ALSO SHOULD ALSO KNOW THAT THIS IS A BIG MARKET FOR PAIN MEDICINES AND SO THIS IS PROFITABLE, SHOULD SOMEBODY HIT A NON-ADDICTIVE VERY EFFECTIVE ANALGESIC AGENT OR SOMETHING THAT PREVENTS CHRONIC PAIN, THAT THIS IS NOT SOMETHING THE MARKET SHOULD SHY AWAY FROM BUT A LOT OF COMPANIES HAVE SHIED AWAY FROM PAIN, AS BILL MENTIONED, DOING PAIN RESEARCH, AND THAT'S NOT GOOD FOR US. WE DO RESEARCH HERE AT NIH AND DEVELOP NEW TARGETS FOR PAIN MEDICINES AND NO ONE PROSECUTES THOSE TARGETS TO MAKE COMMERCIAL PRODUCTS, THEN THE PATIENT NEVER BENEFITS. SO WE ARE REALLY TIED TO THE INDUSTRY IN TERMS OF GETTING OUT TO PATIENTS BUT WE MAKE A STRONG CASE TO THE INDUSTRY THAT IF THE BIOLOGY LINES UP THAT THIS IS SOMETHING THEY SHOULD BE INTERESTED IN, THEY SHOULD NOT BE SHYING AWAY AND SO HOW TO DO THAT. I ALLUDED TO THIS IN THE PREVIOUS SLIDE, THAT THE WORK THAT'S BEING DONE IN THE LABORATORIES NOW ARE COMING UP WITH A PLETHORA OF NEW TARGETS FOR PAIN THERAPY DEVELOPMENT. SO THESE ARE ONES THAT ARE IN A REVIEW THAT WERE PUT TOGETHER BUT THIS MORNING WE DIDN'T HAVE A LOT OF TIME TO TALK ABOUT IT. EVERY MONTH OR SO IN THE MAJOR HIGH IMPACT SCIENCE JOURNAL THERE'S ANOTHER PAPER WITH ANOTHER TARGET THAT NO ONE HAD EVER IMAGINED BEFORE. AND TO MAKE USE OF THESE THINGS FOR PATIENTS WE NEED TO SOMEHOW DEVELOP WAYS OF TURNING THESE INTO MEDICATIONS OR NON-PHARMACEUTICAL THERAPIES THAT ATTACK THESE TARGETS. BUT IT'S NOT THAT WE DON'T HAVE THINGS TO GO AFTER. THE THING IS THAT THE PROCESS FOR MOVING THINGS OUT FROM DISCOVERY TO PATIENTS HAS BEEN INCREDIBLY SLOW FILLED WITH FAILURES AND EXPENSE IRV AND THAT'S WHERE THE PHARMACEUTICAL COMPANIES ARE HAVING SECOND THOUGHTS OR THIRD THOUGHTS OR FOURTH THOUGHTS. SO ONE THING WHICH WE'LL COME BACK TO IS THE FACT THAT THERE IS THIS WHAT WE ALL KNOW AROUND THE TABLE THAT PAIN IS ALL NOT THE SAME. IT ALL HURTS BUT THERE ARE DIFFERENT PAIN SYNDROMES AND THE BIOLOGY OF THESE DIFFERENT PAIN SYNDROMES ARE GOING TO BE VERY DIFFERENT IN SOME ASPECTS AND MAY CONVERGE IN SOME AREAS OF THE BRAIN THAT NORA TOLD YOU ABOUT BUT THERE MAY ALSO BE WAYS TO KIND OF GO AFTER PARTICULAR PAIN CONDITIONS AND THESE MAY BE, YOU KNOW, LESS ENTANGLED WITH REWARD SYSTEMS IN THE BRAIN WHERE THE CURRENT OPIOID DRUGS ARE PLAYING A ROLE BOTH IN PAIN AND IN REWARD, AND TRYING TO SEPARATE THOSE OUT PHARMACOLOGICALLY WHAT FRANCIS SAID, THERE'S ONE WAY OF DOING IT. THE OTHER WAY IS TARGET DIFFERENT CIRCUITS, PREFERENTIALLY TO REDUCE THE ADDICTIVE AND NON-ADDICTIVE PROPERTIES. DORSAL GANGLION CELLS, OPIOIDS ARE IMPORTANT IN TERMS OF MODULATING DORSAL GANGLION CELLS BUT THAT'S NOT WHERE ADDICTION COMES FROM. OKAY. THE OTHER SIDE OF THE COIN HERE IS SOMETHING WHICH WE'LL COME TO IN THE NEXT SLIDE WHICH IS AT THE MEETINGS WE MADE A LIST OF THE -- THIS IS THE PHARMACEUTICAL COMPANIES TALKING ABOUT WHAT ARE THE BIG CHALLENGES THAT THEY ARE FACING IF WE WANT TO GET THERAPIES OUT, WE HAVE TO MEET THESE CHALLENGES. AND AS FRANCIS SAID, YOU KNOW, EVERYBODY LOVES TO BLAME THE FDA. SHARON, SHE'S USED TO IT. DOESN'T MATTER. BUT, YOU KNOW, THE FDA IS THERE TO PROTECT THE COUNTRY FROM THINGS THAT ARE DANGEROUS, AND A MEDICINE THAT'S GOING INTO 22 MILLION PEOPLE, YOU KNOW, IF IT ACTUALLY CAUSES CARDIAC DEATH THAT'S GOING TO BE A PROBLEM. AND THAT'S NOT SOMETHING THE FDA CAN LET GO FORWARD. SO HOW DO YOU MOVE OFF THAT BASE? AND THE IDEA THAT CAME UP WAS REALLY RELATED TO THE PREVIOUS SLIDE WHICH IS ONE WAY TO DO THIS IS TO INSTEAD OF GOING AFTER MEDICATION THAT'S GOOD FOR ALL THE PAIN AND 25 MILLION PEOPLE IS GOING TO TAKE IT IS SEGMENT THE PAIN POPULATION INTO DISCRETE SUBTYPES, PARTICULARLY THOSE THAT HAVE NOT SO VERY GOOD TREATMENTS AND THERE, YOU KNOW, IF YOU DEVELOP A TREATMENT FOR THE COMBINED SUBSET THEN THE RISK/BENEFIT IS GOING TO BE EASIER TO PUT YOUR HANDS AROUND AND, YOU KNOW, IF IT DOESN'T WORK THEN YOU FOUND OUT IT DOESN'T WORK. IF IT DOES WORK, THEN FOR YOU TO GO TO ANOTHER POPULATION YOU HAVE TO DO ANOTHER CLINICAL TRIAL, THEN MOVE INTO THE NEXT POPULATION, BUT IT'S NOT ALL OF A SUDDEN GOING INTO WIDESPREAD DISTRIBUTION TO MILLIONS AND MILLIONS OF PEOPLE. SO THERE WE SEE THERE MAY BE A WINDOW FOR GETTING THE COMPANIES INTERESTED IN TAKING ON A DIFFERENT KIND OF RISK/BENEFIT SCENARIO WITH ADVICE FROM THE GROUPS AND PATIENTS WHO SUFFER AND IN CONCERT WITH THE FDA. SHARON, DID I PUT THAT RIGHT? THAT WAS OKAY. OKAY, GOOD. THE NEXT PROBLEM WHICH CAME UP IS THAT THE MODELS THAT THE COMPANY'S BEEN USING TO BRING THINGS OUT OF THE PRE-CLINICAL SPACE INTO THE CLINICAL SPACE HAVE HAD FAILURES. AND IN THEIR MIND IT'S A CRISIS. SO YOU HAVE TO BLAME SOMEBODY FOR A CRIES IT. CRISIS, AND THEY BLAME THE MICE. IT MIGHT THE NEW BE THE MICE, MIGHT BE THE PEOPLE, SCIENTISTS WORKING WITH THE MICE BUT THEY ARE BLAMING THE MICE. OTHER PEOPLE SAID ANYTHING YOU GOT INTO PEOPLE ALWAYS WORKED IN THE RODENT, THAT'S HOW YOU GOT IT OUT TO PEOPLE. THERE AREN'T EXAMPLES OF THINGS THAT WORKED IN PEOPLE THAT DIDN'T WORK IN RODENTS BUT THERE'S A LOOED OF THINGS THAT WORK IN RODENTS THAT DON'T WORK IN PEOPLE. CAN YOU DO BETTER, CAN YOU DEFINE THE PRE-CLINICAL EXPERIMENTATION ALGORITHM WHERE YOU'RE CHECKING IF THIS WORKS AND THIS WORKS AND THIS WORKS WE GO INTO PATIENTS, CAN WE ENGINEER THAT BECAUSE IT HASN'T BEEN LOOKED IT IN AN ENGINEERING FASHION. MOST OF THE COMPANIES USE CROs, SEND COMPOUNDS OUT, THE COMPANIES IN OREGON GIVE YOU THE DATA BACK BUT THERE'S NOBODY THINKING, GEE, THAT WASN'T VERY PREDICTIVE AND LET'S SEE WHAT WAS WRONG AND IF WE CAN CHANGE IT. SO THIS WOULD BE AN IDEA THAT POTENTIALLY COULD HELP EVERYONE IF WE COULD FIGURE OUT A BETTER WAY TO TEST THINGS HIGHER PREDICTABILITY WHEN YOU GO INTO HUMANS AND THIS COULD NOWADAYS INVOLVE HUMAN CELLS BECAUSE YOU CAN MAKE DORSAL ROOT GANGLION CELL LIKE CELLS FROM CELLS FROM INDUCED PLEURIPOTENT, OR ORGANOIDS, WHERE THE INDUCED PLEURIPOTENT CELLS ARE ALLOWED DIFFERENTIATE INTO THINGS IN CERTAIN INSTANCES THAT ARE LIKE THE RETINA OR CORTEX, COULD WE DO THAT IN THE DORSAL OR SPINAL COLUMN? MAYBE. OKAY. THE OTHER PROBLEM WHICH IS KEEPING US BACK NOT JUST IN PAIN BUT IN PRETTY MUCH ALL THE NEUROLOGICAL DISORDERS WHERE WE CAN'T IMAGE THE PATHOLOGY ON A REGULAR BASIS IS THAT WE DON'T HAVE BIOMARKERS FOR THESE CONDITIONS AND SO A COMPANY IS FORCED TO GO FROM THE RAT INTO A HUMAN, NOT KNOWING WHAT'S GOING ON IN THE BRAIN, JUST WAITING SIX MONTHS AND SEEING WHAT'S HAPPENED. YOU KNOW, THE BRAIN IS BASICALLY TREATED AS A BLACK BOX. YOU MAY HAVE SOME IDEA WHAT THE DRUG IS SUPPOSED TO DO. AND YOU CAN MAYBE TEST THAT IN THE ANIMAL, MEASURE SOMETHING THAT RELATES TO WHAT THE DRUG IS DOING IN THE ANIMAL, BUT YOU REALLY LIKE TO GO INTO THE HUMAN AND FIND OUT, YOU KNOW, AT THE DOSE YOU CHOSE, AT THE DURATION YOU GAVE THE DRUGS, AT THE FORMULATION THAT YOU USED TO GIVE THE DRUG, DID IT ACTUALLY DO WHAT YOU THINK IT WAS GOING TO DO FROM YOUR RAT EXPERIMENT, SO BIOMARKERS CAN BE MEANING A LOT OF THINGS, IN THIS SPACE WE'RE TALKING ABOUT MEASUREMENTS MADE IN THE HUMAN THAT REFLECT THAT THE DRUG IS ACTUALLY HITTING ITS TARGET, TARGET ENGAGEMENT OR PROOF OF PRINCIPLE THAT THE DRUG IS DOING SOMETHING IN THE HUMAN THAT YOU WANTED IT TO DO FROM YOUR ANIMAL MODELS. SO THESE KIND OF BIOMARKERS ARE INCREDIBLY IMPORTANT. TRIPP SHOWED HIS DIAGRAM OF HOW BAD YOUR PAIN IS, THE LAST ONE I KNOW IS CAN'T GET ANY WORSE. THAT'S WHAT IT WAS? WHAT WAS THE LAST -- WHAT? >> (INAUDIBLE) >> NOTHING ELSE MATTERS, RIGHT, RIGHT. THERE'S ANOTHER ONE FROM MY EXPERIENCE WAS THE PAIN CANNOT GET ANY WORSE. I CAN'T IMAGINE HOW IT CAN GET ANY WORSE. AND THE NEXT MONTH I CAN'T IMAGINE HOW IT COULD GET WORSE BUT IT IS WORSE. SO PAIN IS AMAZING IN TERMS OF JUST HOW BAD IT CAN GET. BUT WHAT WE USE NOW ARE SCALES, AND THEY DEPEND PROBABLY ON NOT JUST THE IMPULSES COMING FROM THE DORSAL ROOT GANGLIA BUT OTHER THINGS, HARD TO KNOW WITH A DRUG WHAT IT'S HITTING. WE HAD SOME KIND OF OBJECTIVE MEASURE OF NOCICEPTION EVEN OR MAYBE EVEN GOING BEYOND NOCICEPTION TO THAT EXPERIENCE OF PAIN THAT COULD BE MEASURED, DRUGS COULD BE TESTED AGAINST IT, THAT WOULD BE ALSO REALLY TRANSFORMATIVE. THE LAST THING WHICH REALLY HAS RELATIONSHIP TO ALL THESE THINGS IS THAT THE CLINICAL RESEARCH RESOURCES THAT WE HAVE FOR PAIN RESEARCH REALLY PALE IN COMPARISON TO SAY WHAT WE HAVE FOR CANCER RESEARCH WITH BIG CANCER CENTERS AROUND THE COUNTRY OR EVEN HAVE A STROKE NETWORK WITH 25 SITES AROUND THE COUNTRY, EACH HAVING 5 TO 6 HOSPITALS SO 300 SITES TO DO PAIN RESEARCH, I THINK, YOU KNOW, THE QUESTION FOR THE GROUP WHICH I'D REALLY LIKE TO HEAR ABOUT IS HOW WOULD WE PUT SOMETHING LIKE THAT TOGETHER FOR THAT PAIN RESEARCH BECAUSE WE MAY HAVE THE OPPORTUNITY TO DO THAT HERE AS I'LL SHOW YOU. THESE ARE THE KIND OF MENU OF ITEMS THAT CAME OUT OF THE DISCUSSIONS THAT ARE NOW KIND OF ON THE TABLE AND AS FRANCIS MENTIONED, THE COMPANIES HAVE BEEN TALKED TO, THEY HAVE SAID WE'RE GOING TO WORK WITH YOU. THEY HAVEN'T SAID WHAT THEY ARE GOING TO WORK ON YET. WE HAVE A MENU TO GAUGE INTEREST ON WHICH ONE OF THESE THINGS CAN GO FORWARD. WE THINK ALL ARE VALUABLE. THE FIRST HAS VERY LITTLE TO DO WITH NIH, NIH WOULD BE A NEUTRAL BROKER FOR THE INDUSTRY TO SHARE INFORMATION AND DATA ON THE PAIN THERAPY PROJECTS THAT THEY HAVE HAD IN TERMS OF WHAT FAILED, WHAT WORKED, AND THE IDEA HERE WAS SIMPLY FOR THE INDUSTRY TO HELP THEMSELVES FROM NOT FAILIG. THEY NOW HAVE INFORMATION THAT WOULD, YOU KNOW, ANOTHER COMPANY IS DOING SOMETHING SIMILAR TO WHAT THEY ALREADY DID AND THEY KNOW IT'S NOT GOING TO WORK BUT THEY DON'T TELL ANYBODY AND SO THE QUESTION CAME UP, AMONG INDUSTRY FOLKS, MAYBE IT'S TIME TO CHANGE THAT. THE NEXT ONE IS A CLINICAL TRIAL NETWORK WHICH I JUST WAS TALKING ABOUT TO KIND OF GO DOWN AND SPECIFY WITH SPECIFIC PAIN CONDITIONS TO STUDY THOSE PATIENTS, DEEPLY PHENOTYPE THEM, TRY TO DEVELOP BIOMARKERS AND THEN TEST THERAPIES IN THOSE CONFINED GROUPS. THAT WOULD REQUIRE, YOU KNOW, A NETWORK TO DO THAT BECAUSE IT'S NOT GOING TO BE THE MOST COMMON PAIN CONDITION. IT'S GOING TO BE PAIN CONDITIONS PROBABLY LESS COMMON, DEFINITE NEED GROUPS TO WORK TOGETHER THERE. IF WE'RE GOING TO DO BIOMARKER WORK WE'RE GOING TO NEED A NETWORK. THERE ARE INDUSTRY -- INDUSTRY HAS BEEN SAYING THEY HAVE DEPRIORITIZE, IT MIGHT BE ABLE TO TEST THEM TO SEE IF SOME OF THOSE THINGS THAT THEY HAVE SHELVED CAN BE HELPFUL. COMBINATION THERAPIES IS SOMETHING THAT CAME UP FROM THE PHARMACEUTICAL COMPANIES IN ONE OF THE RECENT MEETINGS TO TEST. THE BIOMARKER IDEA I KIND OF TALKED ABOUT, IT WOULD BE USEFUL TO TEST WHETHER A DRUG HITS TARGET TO STRATIFY PAIN POPULATIONS, BETTER PREDICT CLINICAL OUTCOMES IN RESPONSE TO CLINICAL TREATMENT, PHASE 2 CLINICAL TRIALS AND DEVELOP OBJECTIVE MEASURES FOR ACTUAL PAIN SENSATION OR DAVE THOMAS' FAMOUS PAIN-O-METER, FOR PHASE 2 TRIALS, NOT BIG PHASE 3 INDICATION TRIALS BUT BIOLOGICAL MEASURES TO KNOW FOR THE PHARMACEUTICAL COMPANY TO KNOW THEY HAVE SOMETHING THAT MIGHT WORK. I TALKED ABOUT REENGINEERING CLINICAL PLATFORM. WHAT NIH DOES IS TO WORK ON DISCOVERING NEW TARGETS, WE'LL CONTINUE DOING THAT BUT WORKING WITH INDUSTRY YOU MIGHT BE ABLE TO FIGURE OUT WAY WE CAN MOVE THOSE TWO THERAPIES QUICKER. NIH IS INTERESTED IN WORKING OUT THIS PROGRAM OF THE PREVENTION OF THE TRANSITION FROM ACUTE TO CHRONIC PAIN. AND ALWAYS DEVELOPING NEW TECHNOLOGIES TO DISCOVER, YOU KNOW, MORE IMPORTANT IMPACTFUL PAIN TARGETS. WITH THAT I'D LIKE TO END AND IT WOULD BE GREAT IF WE COULD HAVE SOME DISCUSSION. NORA AND I WOULD CERTAINLY APPRECIATE YOUR THOUGHTS ON, YOU KNOW, HOW WE MIGHT ACTUALLY OPERATIONALIZE SOME OF THESE THINGS GOING FORWARD. FOR THE PAIN FIELD WOULD BE A NEW WORLD IF WE COULD GET THE RESOURCES FRANCIS IS PUSHING FOR. WITH THAT I'LL HAVE A SEAT AND HAPPY TO OPEN THE DISCUSSION. >> QUESTIONS FOR WALTER? >> LET ME ASK WHAT'S ON MY MIND. WHO DO PEOPLE THINK IS THE BANDWIDTH FOR THE COUNTRY'S PAIN CENTERS TO DO KIND OF HIGH LEVEL CONSORTIUM RESEARCH AT THIS POINT? WHAT WOULD IT TAKE TO GET THOSE GROUPS TOGETHER? >> I'LL START THE COMMENTS. I THINK THE TIME IS RIGHT. THERE HAVE BEEN SEVERAL RELATIVELY LARGE COHORT STUDIES DONE AT SEVERAL UNIVERSITIES AND MEDICAL CENTERS THAT SPEAK TO ABILITY OF GROUPS TO PUT TOGETHER MODELS, STUDY DESIGNS WHERE ONE COULD LOOK AT RISK DETERMINANTS, MOLECULAR SIGNATURES UNDER BOTH HETEROGENEOUS AND HOMOGENOUS POPULATIONS. AND THERE'S EVIDENCE THAT THIS TYPE OF APPROACH HAS LED TO TARGET DEVELOPMENT THROUGH REVERSE TRANSLATION THAT CAN BE VALIDATED, HAS BEEN VALIDATED IN ANIMALS, CELLULAR MODELS THAT GO FORWARD BACK TO HUMAN. SO I THINK THERE'S SEVERAL NETWORKS THAT EXIST AND CAN BE EXPANDED EASILY, ALL THE WAY FROM THE ONE THAT I'M MOST FAMILIAR WITH WITH ROGER'S OPERA BUT THERE'S MAPP, THERE'S ACTION, THERE'S SEVERAL NETWORKS THAT EXIST THAT I THINK ARE WELL POISED TO BEGIN TO TAKE ON THIS CHALLENGE. AND THAT WOULD WORK TOGETHER TO DEVELOP THE RIGHT DESIGNS, TO DEVELOP THE DATA SHARING PROCESSES, AND TO WORK TOWARDS TARGET DEVELOPMENT. AND I THINK I KNOW THAT INDUSTRY HAS INTEREST IN THIS PROCESS. >> CAN I ADD I THINK THE V.A. AND DoD HEALTH CARE SYSTEMS ARE WORTH EXPLORING GIVEN THE POPULATION AND GIVEN THE FACT THAT WE ARE -- AT LEAST NIH IS WORKING MORE CLOSELY WITH THOSE GROUPS THAT THERE'S MOMENTUM TO THINK ABOUT HOW TO PARTNER WITH THEM IN THE FUTURE. >> EXCUSE ME. OH, SORRY. YOU GO FIRST. >> ARE WE FOCUSED MOSTLY ON THE MOLECULAR? IS THERE INTEREST IN BIOMECHANICAL RESEARCH? >> I MEAN, DISCUSSION WITH PHARMACEUTICAL COMPANY SO FAR, NO. EVEN DEVICE AREA, YOU KNOW, DORSAL COLLAR STIMULATORS ARE EFFECTIVE IN SOME PEOPLE. WE HAVEN'T BEEN ABLE TO REALLY GET INTEREST AT THAT LEVEL YET. >> BUT I ACTUALLY, IN FAIRNESS, WE PUT ENORMOUS AMOUNT OF EFFORT AND WERE SUCCESSFUL IN GARNERING SUPPORT WITH PHARMA BUT DON'T HAVE THE SAME WITH DEVICES, FRANCIS REACHED OUT TO BIOTO OF FOR POTENTIAL PARTNERS, ANOTHER POSSIBILITY FOR PUBLIC/PRIVATE PARTNERSHIP AND I THINK THAT WE NEED TO CARRY THROUGH THE ISSUES HOW MUCH BANDWIDTH WE HAVE IN DEVELOPING THE PUBLIC/PRIVATE PARTNERSHIP, WE WANT TO GET THIS FLYING AND TALK WITH SOME OF THE NEXT ONE WITH DEVICE INDUSTRY BECAUSE IT'S A DIFFERENT SPACE. >> WALTER, WE TRIED TO PUT TOGETHER A NETWORK OF PEDIATRIC PAIN RESEARCHERS. I THINK SHARON IS AWARE OF PRN PAIN. WE GAVE SO MANY CORE FUNDING TO BUILD THEIR COLLEGIALITY, AND YOU MENTIONED CONVENING BEFORE, YOU MAY BE POISED TO CONVENE PEOPLE WHO NORMALLY COMPETE WITH EACH OTHER, IF THEY ARE LOOKING FOR A GRAND FROM YOU BUT IF YOU RAISE THAT BAR A BIT HIGHER AND SAY WE NEED TO GET LARGER SCALE DATA IN MULTIPLE INSTITUTIONS THEY COME FORWARD. SO SOME KIND OF INCENTIVIZING GRANT TO BUILD A NETWORK. >> I THINK IT WOULD BE HELPFUL IF WE CAN HARNESS YOUR CONTACTS TO PUBLICIZE THINGS BECAUSE WHAT HAPPENS IS WE -- WHAT THE NIH DOES IS PUT OUT A CALL FOR SITES AND THE MOST PREPARED EVENTUALLY WIN IN THE PEER REVIEW PROCESS. SO IF WE HAVE THE OPPORTUNITY TO DO THIS THEN WE GET THE WORD OUT, PEOPLE START COMING TOGETHER, THAT WOULD BE GREAT. >> IF I COULD PIGGYBACK, I DON'T KNOW HOW PCORI WORKS WELL BUT THEY WORK ON A COLLABORATIVE MODEL AND I THINK WE COULD EASILY LEVERAGE WHAT WE WANT TO DO FROM THEIR NETWORKS AS WELL. I THINK IT'S ALMOST AT THAT -- YOU HAVE TO CAPTURE PEOPLE'S IMAGINATIONS THAT THEY CAN WORK TOGETHER AND THEN THEY WANT TO. >> I WANT TO MAKE ANOTHER COMMENT FOR INTEGRATIVE HEALTH. I UNDERSTAND THE ISSUE WITH MEDICATIONS IS WHERE THE MONEY IS COMING FROM, ANESTHESIOLOGISTS HAVE BEEN PUSHING DRUGS ALL MY LIFE, BUT USING THE EXAMPLE OF THE V.A./DoD STEP CARE MODEL THERE IS A ROLE FOR INTEGRATIVE HEALTH ALONG WITH MEDICATIONS SO THE DISCUSSION WITH THE PHARMACEUTICAL COMPANIES IS YOU'RE SOMEWHERE IN THE MIX BUT YOU'RE PART OF THE MIX. YOU CAN STILL MAKE YOUR MONEY BUT ALONG THE WAY YOU'LL HAVE TO INVEST IN WHERE THIS WORKS IN AN INTEGRATIVE LET PROGRAM WHICH INCLUDE NON-DRUG MODALITIES WHERE MEDICATIONS COULD BE WORKING WITH THOSE MODALITYS. THE FACT IS UNFORTUNATELY THAT'S NOT WHERE ANY OF THE MONEY IS. BUT I CAN TELL YOU THAT THE SOLDIERS RIGHT NOW, THE SERVICE MEMBERS, ARE VOTING WITH THEIR FEET. THE JOKE BEING WE USED TO HAVE TATTOO PARLORS AND PEEP SHOWS OUTSIDE THE GATE. NOW WE HAVE ACUPUNCTURE CLINICS AND MASSAGE THERAPISTS, THIS POPULATION IS MAKING A DECISION FOR US. IT WOULD BE A MISTAKE NOT TO INSIST DURING THIS PUBLIC/PRIVATE PARTNERSHIP THAT RESOURCES ARE DIRECTED IN THIS MANNER AGAIN USING THAT V.A. STEP CARE MODEL, AN APPROACH TO HOW I THINK PAIN MANAGEMENT SHOULD BE APPROACHED IN THIS COUNTRY. >> BUT THERE'S ALREADY A FAIRLY ROBUST LITERATURE THAT SUPPORTS THE USE OF AN INTEGRATIVE MODEL, INTERDISCIPLINARY MODEL IN MANAGING PATIENTS IN TERMS OF IMPROVING FUNCTION, IMPROVING ABILITY TO RETURN TO WORK, LESS USE OF RESOURCES. I MEAN, IT'S NOT LIKE -- (INAUDIBLE) -- A SCIENTIFIC QUESTION THAT NEEDS TO BE ANSWERED. THE LITERATURE IS THERE. THE PROBLEM IS WHO IS GOING TO PAY FOR IT? RIGHT NOW -- >> THE PHARMACEUTICAL COMPANIES. >> THEY MIGHT BE -- WE MIGHT HAVE A HOOK TO GET THEM INTO RESEARCH PROTOCOLS BUT THAT'S NOT THE ISSUE. THE ISSUE IS -- PART OF THE REASON I THINK WE'VE SEEN THE REMARKABLE RISE IN OPIOID PRESCRIBING IS IN THE '90s WE BECAME AWARE PEOPLE WEREN'T GETTING PAIN MANAGED VERY WELL AND A LOT OF EFFORT WENT TOWARD TRYING TO IMPROVE PAIN MANAGEMENT. AND WHAT WE ALSO FOUND, IT WAS SOMEBODY HERE WHO HAD PRESENTED THIS AT A PRIOR MEETING AS WELL, I KNOW THERE'S AN AhRQ REVIEW, PRACTITIONERS WITH INTERDISCIPLINARY CLINICS WERE NOT GETTING REIMBURSEMENT AND COULDN'T KEEP DOORS OPEN. IF YOU LOOK AT AVAILABILITY OF THAT TYPE OF PAIN CARE IN THIS COUNTRY RELATIVE TO ANY OTHER SIMILARLY ECONOMIC LEVEL COUNTRY IN EUROPE, THE AVAILABILITY IN THIS COUNTRY HAS BEEN DECLINING AND IN OTHER COUNTRIES INCREASING. PEOPLE SAY WHY DO WE USE 90% OF THE WORLD'S OPIOIDS IT'S BECAUSE THAT'S WHAT GETS REIMBURSED. IT'S GOOD TO BRING CMS IN BUT THAT'S NOT ENOUGH BECAUSE CMS ONLY COVERS A SMALL FRACTION. IF WE DON'T GET PAYORS IN IT DOESN'T MATTER WHAT AMAZING DRUG IS DEVELOPED IF NO ONE IS WILLING TO PAY FOR IT. WE HEAR THERE'S A CHALLENGE GETTING EVEN THE CURRENTLY AVAILABLE NON-OPIOID ANALGESICS REIMBURSED. SO IF WE DON'T TAKE THIS ELEMENT INTO CONSIDERATION AND FIND SOME WAY TO GET THESE PAYORS INTO THIS MODE, IT DOESN'T REALLY MATTER WHAT ELSE GETS DONE. THE COST OF TREATING PAIN ACUTELY OR TREATING CHRONIC PAIN UP FRONT IS HIGH. SO IT'S EASIER FOR A THIRD PARTY PAYOR TO JUST USE AN INEXPENSIVE MANAGEMENT TECHNIQUE. BUT THE COST DOWNSTREAM THEN IS BORNE BY SOCIETY. AND THE PATIENTS. AND NOT THE THIRD PARTY PAYOR. SO THAT DISCONNECT IS A SYSTEMATIC PROBLEM AND UNTIL THAT'S ALSO PART OF THIS, SO WORKING WITH CMS IS GOING TO BE HELPFUL BUT IT'S GOING TO BE AN ONGOING ISSUE. >> I WOULD ARGUE THAT WE'RE NOT CAPTURING THE WASTED COSTS NOW. I'VE SAID THIS EXAMPLE BEFORE BUT I DO MOST OF MY WORK IN POLICY. I'VE RUN A VERY LARGE SUPPORT GROUP FOR THE LAST 17 YEARS. MORE THAN 350 PEOPLE HAVE COME TO THIS LITTLE LOCAL GROUP WITH EVERY IMAGINABLE KIND OF PAIN. THERE IS NOT A SINGLE PERSON THAT HAS COME TO THIS GROUP THAT HASN'T HAD TO SEE AT LEAST FIVE PRACTITIONERS AND I CAN'T EVEN TELL YOU HOW MANY TESTS, NEEDELS THAT HAVEN'T WORKED. SO WE'RE WASTING ENORMOUS AMOUNTS OF MONEY. INSURANCE COMPANIES ARE PAYING FOR IT ONE WAY OR ANOTHER. AND WHAT WE HAVEN'T CAPTURED IS THE LACK OF COST EFFECTIVENESS, THE WASTED RESOURCES THAT GO INTO PAIN BECAUSE WE'RE TAKING SUCH A POOR, POOR CARE OF IT. THE MODEL OF THE SUPPORT GROUP AND EXPOSURE THAT I'VE BEEN ABLE TO GIVE THESE PEOPLE TO DIFFERENT PRACTITIONERS AND THE IDEA THAT PAIN IS SOMETHING, A CHRONIC CONDITION, IT'S NOT GOING TO GO AWAY, YOU HAVE TO LEARN TO LIVE WITH IT, SO THE COMBINATION OF SUPPORT NETWORKS, SHOWING COST EFFECTIVENESS OF THOSE THINGS IS PERHAPS A WAY TO INTEGRATE THE KIND OF THING TRIPP IS TALKING ABOUT AS WELL. I STILL FEEL STRONGLY FOR PEOPLE WITH VERY SEVERE PAIN PHARMACOLOGY HAS GOT TO BE IN THE MIX. IT'S JUST YOU'RE NOT GOING TO BE ABLE TO THINK AWAY WITH MIND/ BODY TECHNIQUES EXTREME PAIN. >> FIRST I THINK THE CONCEPT OF BUNDLED SERVICES THAT CMS WILL ENDORSE ANDEN REIMBURSED FOR MULTI-SPECIALTY TREATMENT AND BIOSPHERE, INCLUDING THERAPY, IS ONE WAY WE MOVE FORWARD AND BEGIN TO BRING PATIENTS OFF THE STREETS AND BACK INTO OUR CLINICS IF WE CAN MOVE TO REIMBURSEMENT MODELS THAT MOVE FROM RVU TO A BUNDLED SERVICE TIME MODEL. THE SECOND COMMENT SOMEWHAT RELATED IS THAT GOING BACK TO THE DISCOVERY AND CLINICAL TRIALS, TWO PHASES, ONE DESIGNED TO LOOK AT TARGET IDENTIFICATION IN SUBPOPULATIONS OF INDIVIDUALS. THE SECOND IS USING PRAGMATIC TRIALS TO LOOK AT SIGNAL AND POTENTIAL EFFICACY OF AGENTS IN A CLINICAL SETTING WHERE MANY ALTERNATIVE METHODS WILL BE USED TO MAKE THIS GENERALIZABLE IN REAL WORLD. I THINK AT LEAST TWO PHASES OF IN THIS DISCOVERY PHASE OF TARGET DEVELOPMENT VALIDATION THROUGH REVERSE TRANSLATION AND WHEN WE MOVE FORWARD WITH A COMPOUND THAT WILL BE DONE IN A PRAGMATIC SETTING WHERE IDEALLY YOU WOULD WANT TO HAVE BUNDLED SERVICES THAT WOULD PAY FOR THIS. >> YEAH, I THINK SORT OF JUMPING IN ON THIS, YOU MENTIONED IN ONE OF YOUR SLIDES, WALTER, IT WAS INTEREST IN COMBINATION THERAPY, I PRESUME PHARMA HAS INTEREST IN DRUG COMBINATIONS, BUT BECAUSE INTEGRATIVE APPROACHES HAVE BIOLOGICALLY EFFECTS, ACTIVE AGENTS, TO ME AN OPENING FOR STUDYING AND INSISTING ON STUDY OF TREATMENTS IN COMBINATION WITH OTHER PHARMACOTHERAPIES NOT IMPOSSIBLE BUT DIFFICULT TO ARGUE AGAINST. >> THE NATIONAL ACADEMY OF SCIENCE HAD A WORKSHOP ON MULTI-MODAL TREATMENTS. UNFORTUNATELY IT DEALT WITH PSYCHIATRIC AND NEUROLOGIC. UNFORTUNATELY THERE WASN'T A TOPIC FOR PAIN. BUT A STUDY HOW TO BEST THINK ABOUT DOING THIS MIGHT BE A FIRST STEP. AND MAYBE THE NATIONAL ACADEMY COULD DO SOMETHING IN THAT AREA, I DON'T KNOW, BUT THEY HAVE TACKLED IT FOR OTHER CONDITIONS. >> A COUPLE OF COMMENTS AND QUESTIONS. FIRST IS TO GO BACK TO THE DIALOGUE ABOUT THE PUBLIC/PRIVATE PARTNERSHIP AND HOW CAN THAT BE PUSHED IN A SUITABLE DIRECTION. THE CONCEPT OF MULTI-MODAL ANALGESIA IS AN OLD CONCEPT, CERTAINLY IN ACUTE PAIN, THERE MIGHT BE A BIAS AGAINST APPROVING AGENTS WHICH ARE DESIGNED TO BE ONE COMPONENT OF MULTI-MODAL THERAPY, BECAUSE IF YOU'RE ADDING A SECOND OR THIRD AGENT IT'S A TRICKIER THING TO DEMONSTRATE AN EFFECT. IN ADDITION, AS MY LIMITED UNDERSTANDING OF NEW DRUGS APPROVAL GOES, IF YOU WERE TO HAVE A DRUG THAT HAD NO OTHER EFFECT UPON PAIN OTHER THAN TO SPARE OPIOIDS, THAT WOULD PROBABLY NOT GET APPROVED. YOU'D HAVE TO HAVE AN ANALGESIC EFFECT PRIMARILY. >> ABSOLUTELY UNTRUE. >> OKAY. SO IF THERE WERE NO -- WELL, LET ME GET TO THE POSITIVE. THE POSITIVE POINT WOULD BE THAT I THINK IT WOULD BE WORTH REEXAMINING THE PITCH TO PHARMA WHICH IS TO SAY WE'D LIKE TO GET YOUR DRUG APPROVED AND WE'RE ALTERING THE PROCESS IN LIGHT OF PUBLIC HEALTH ISSUE OF OPIOIDS IN THE SENSE THAT MANUFACTURER WOULD BE INCENTIVIZED TO DESIGN DRUGS DESIGNED TO BE ONE PHONENT -- COMPONENT OF A COCKTAIL. EVEN IF FIRST GLANCE VIEWED AT TRIVIAL, IF YOU HAD TWO OR THREE AGENTSES, EACH CAPABLE OF A TWO-POINT REDUCTION ON 0 TO 10 SCALE YOU HAVE A REGIMEN PRACTICAL FOR PATIENTS. ONE THING TO GET ON THE TABLE FOR DISCUSSION IS REEXAMINE THE INCENTIVIZATION TO DEVELOP AGENTS DESIGNED TO BE ONE COMPONENT OF MULTI-MODAL THERAPY. THIS HAS BEEN GOING ON FOR A WHILE IN ANESTHESIA. ANOTHER POINT TO GET ON THE TABLE IS THAT WE'VE KIND OF ASSUMED IN THESE DISCUSSIONS NOCICEPTION DRIVES PAIN EXPERIENCE BUT WE UNDERSTAND FROM IMAGING FORGOTTEN HALF OF THE PAIN EQUATION HAS TO DO WITH STIGMA, ISOLATION, MARGINALIZATION AND FROM TYPICAL EXPERIENCE OF A MOTHER COMFORTING A CHILD AFTER A BRUISE, IT IS HIGHLY EFFECTIVE, DEVELOPING PHARMACOLOGICAL WAYS THREE OXYTOCIN OR ANALOGS THAT COMBINE WITH RECEPTOR ACTIVITIES. THEY HAVE BIOLOGIC EFFECTS. THE OTHER HALF OF THE PAIN EQUATION IS DYSPHORIA ISOLATION. WE NEED TO FIGURE OUT HOW LONG SHOULD TRIALS LAST. PEOPLE DISMISS LITERATURE BECAUSE NOT MUCH HAS BEEN DONE IN EXCESS OF A YEAR. THERE ARE A LOT OF REASONS BUT THERE NEEDS TO BE REVISITING OF THAT SO THAT AT THE END OF ALL THIS IF ONE WINDS UP FUNDING 20 TRIALS, EACH LASTING THREE MONTHS YOU DON'T HAVE SOME CONGRESSMAN SAYING THAT'S IRRELEVANT, I WANT TO SEE AT LEAST A YEAR, AND IF YOU DIDN'T HAVE A YEAR'S DURATION WHY WASN'T THERE A YEAR. >> I AGREE WITH A LOT SAID AROUND THE MULTI MODAL APPROACH, WHAT I HAVEN'T HEARD IS WE'RE NOT GIVING THE PERSON WITH THE PAIN RESPONSIBILITY TO FOLLOW THROUGH. WE CAN HAVE ALL THE PASSIVE THERAPY WE WANT BUT WE HAVE TO TEACH THEM AS WELL ON HOW TO MANAGE THAT PAIN. THAT'S A COMPONENT THAT I HAVEN'T HEARD BUT WE NEED TO FOCUS A LITTLE BIT MORE ON THAT BECAUSE THAT'S REALLY HOW WE'RE GOING TO LONG TERM MAINTAIN THEIR WELLNESS IF WE TEACH THEM. >> THERE'S NO FUNDING FOR THAT. IT'S VERY HARD TO DO THAT KIND OF THING WITH SELF MANAGEMENT PROGRAMS BUT WITHOUT FUNDING TO CONTINUE THAT. WE CAN'T CONTINUE THAT. WE DON'T HAVE FUNDING ENOUGH TO DO THAT, THE KIND OF -- >> I DON'T KNOW. I'VE BEEN DOING -- I'M NOT SURE WHAT KIND OF FUNDING YOU NEED. IT'S FREE. >> THOSE GROUPS DON'T CONTINUE. I MEAN, THE REAL ITY MOST GROUPS DON'T CONTINUE FOR A LONG PERIOD OF TIME BECAUSE THERE'S, YOU KNOW, VOLUNTEERS RUNNING THEM THAT REALLY NEED SUPPORT TO BE ONGOING AND TEACHING OF LEADERS AND ALL THAT KIND OF THING >> ANOTHER TOPIC I JUST WANTED TO ASK A QUESTION ABOUT IS THE ISSUE OF BIOMARKERS WHICH HAS BEEN OF HIGH INTEREST AND CONCERN AND THE PAIN COMMUNITY AND SORT OF WHAT THE DISCUSSION AROUND THAT HAS BEEN AROUND IS THERE A GOAL OF SORT OF SUPPLANTING THE PATIENT'S EXPERIENCE WITH BIOMARKER THAT DOESN'T REQUIRE HAVING TO ASK THE PATIENT HOW THEY FEEL OR USING BIOMARKERS TO MEASURE SORT OF DISEASE ACTIVITY IN SOME SENSE TO SUPPLEMENT PATIENT REPORT OR TO IDENTIFY THE TARGET IN THAT PATIENT. I JUST THINK IT'S IMPORTANT TO MAKE SURE BIOMARKERS ARE USED IN OPTIMAL WAY IN THIS SETTING. >> ALL RIGHT. I THINK IT DEPENDS ON WHAT LEVEL YOU CAN MAKE YOUR MEASUREMENT. FOR INSTANCE, THE EXAMPLE I USED TODAY, IF YOU COULD MEASURE THE microRNA 183 THAT WOULD BE TREMENDOUS, IN TERMS OF, YOU KNOW, UP AND DOWN REGULATING PAIN IN THE DRG, THAT'S A SPECIFIC BIOMARKER TAG TO ONE PARTICULAR PROCESS WHICH IF YOUR NA 1.7, THAT WOULD BE THE SPECIFIC BIOMARKER THAT WOULD BE RELATED TO A PARTICULAR TREATMENT WHERE THE TARGET AND BIOMARKER ARE LINKED. THE OTHER SIDE FURTHER AWAY FROM THAT IS, YOU KNOW, FUNCTIONAL MRI, THE WORK, WORKING ON A PAIN SIGNATURE THAT'S SEPARATE FROM NOCICEPTIVE SIGNAL, TEASE THEM APART, THAT WOULD BE AMAZING. I DON'T THINK IT WOULD SUPPLANT BUT I SUSPECT YOU WOULD FIND IT WOULD HELP YOU SEGMENT THE POPULATION OF PATIENTS AND ALLOW YOU TO DEVELOP TREATMENTS BETTER LIKELY TO BE SUCCESSFUL IN ONE SEGMENT THAN THE OTHER. I THINK THE THING ABOUT THE PROCESS WE'RE TALKING ABOUT IS GETTING AWAY FROM JUST THROWING OR HOW ABOUT A WHOLE BUNCH OF PILLS OUT WAITING SIX MONTHS AND SEEING WHAT HAPPENS. I THINK IN TERMS OF THE -- YOU KNOW, INTEGRATIVE CARE OF THE PATIENT WITH PAIN, YOU KNOW, IF IN THE CASES WHERE, YOU KNOW, THAT'S THE STANDARD OF CARE, WE'RE NOT, YOU KNOW, THOSE ARE WHERE THINGS WOULD BE TESTED AGAINST. ONE THING A COMMUNITY COULD DO IS -- OF COURSE WE HAVE THE BIGGEST PROBLEM IN OUR NETWORKS BECAUSE EVERYONE HAS A DIFFERENT STANDARD OF CARE IS TO STANDARDIZE. CAN YOU GO SO FAR WHERE DATA IS NOT THERE, YOU CAN'T FORCE PEOPLE IN, BUT TO GET A GROUP TOGETHER AND SAY THIS POPULATION, THIS IS THE STANDARD OF CARE, MAYBE SOME PEOPLE WOULD SAY THAT'S NOT WHAT WE DO BUT MAYBE WE SHOULD AND FOR THE RESEARCH THAT WOULD HAPPEN. >> YOU ALSO HAVE TO BALANCE IN THE CONTEXT OF PUTTING THE PHARMACOLOGIC THERAPY INTO MULTI-MODAL OR INTERDISCIPLINARY MODEL IS YOU'RE GOING TO BE CREATING A LOT MORE -- NOT THAT EFFICACY IS FORMULATIONS NOISE BUT HOW DO YOU DETERMINE IF THE DRUG IS HAVING AN EFFECT? IN TERMS OF CREATING BARRIERS YOU'RE MAKING IT HARDER TO DETECT THE SIGNAL. A LOT OF WORK BEING DONE BY A NUMBER OF GROUPS IS TRYING TO FIGURE OUT HOW TO IMPROVE THE SIGNAL DETECTION IN TERMS OF ANALGESICS. IN THE CONTEXT OF USING THE PATIENT AS THE REPORTER OF SUCCESSFUL OUTCOME, IF YOU KEEP DECREASING BACKGROUND PAIN HOW DO YOU DETERMINE IF THE NEW AGENT IS HAVING AN EFFECT? I THINK WHAT WE NEED TO CONSIDER IS MORE COMPREHENSIVE LOOK AT THE DEVELOPMENT PROGRAM. PHASE 2 HAS ALL BUT DISAPPEARED IN DRUG DEVELOPMENT AND I THINK THAT WHAT COULD REALLY BE IDEAL IS TO TAKE A STEP BACK AND STOP SKIPPING THE FUNDAMENTAL ELEMENTS THAT THEN SET YOU UP FOR SUCCESSFUL PHASE 3 STUDY. HAVING BETTER EXPLORATORY WORK IN PHASE 2 WHERE YOU COULD HAVE SOME IN THE CONTEXT OF MORE COMPLETE MANAGEMENT AND SOME, WHERE THE BACKGROUND MANAGEMENT IS LESS, LOOK IN PHASE 2 AND SEE WHAT IS POSSIBLE. IT'S GOING TO ALWAYS BE THAT BALANCE BETWEEN HOW DO YOU SHOW EFFECT OF A DRUG AS AN EFFICACY QUESTION AND HOW DO YOU SHOW THE VALUE OF A DRUG IN THE CONTEXT OF COORDINATED PAIN MANAGEMENT. THOSE ARE DIFFERENT QUESTIONS. AND THE LATTER IS MUCH -- IS AN EXTRA AMOUNT OF POTENTIAL BURDEN. >> IF I COULD JUST PILE ON IN THE CONVERSATION HERE, WHEN WE WERE TALKING ABOUT THE COMMON FUND CONCEPT THAT'S GOING THROUGH AND THE BIOMARKER PIECE OF THAT, THE IDEA WAS THEY ARE LOOKING FOR A SIGNATURE PROBABLY A COMBINATION OF A NUMBER OF DIFFERENT THINGS TO SEE REALLY LOOK FOR RISK FACTOR WITH TRANSITION TO CHRONIC PAIN AND PATIENT REPORTED OUTCOMES, PSYCHOSOCIAL SCREENING TOOLS ARE VERY MUCH A PART OF THAT PIECE THAT WE'RE LOOKING FOR FOR SIGNATURES THERE >> I WASN'T TOO CONCERNED ABOUT THAT BUT IN THE CONTEXT OF CLINICAL TRIALS FROM SOME PERSPECTIVE THAT MIGHT BE IDEAL TO SHOW THE PATIENTS GOT BETTER EVEN IF THEY DIDN'T KNOW THEY GOT BETTER, RIGHT? >> MY UNDERSTANDING IS THAT WE ARE TO DISCUSS THINGS THAT WILL HELP FRANCIS COLLINS ACCOMPLISH HIS GOALS. AND SO IF WE ARE PUTTING THINGS IN THE FRAMEWORK RESEARCH INITIATIVE TO DEFINE RISK OF CONVERSION FROM ACUTE TO CHRONIC PAIN THE SOCIAL STIGMATIZATION CANNOT BE MENTIONED STRONGLY ENOUGH. AND THERE ARE MANY GROUPS THAT FEEL 80% OF PAIN IS ACTUALLY PSYCHOLOGICAL CONDITION, NOT THAT PEOPLE ARE CATASTROPHIZING OR INTENTIONAL DOING SOMETHING, THEY ARE SO MARGINALIZED WITH INTERFACE WITH HEALTH CARE SYSTEM. THE COMMUNITY AND PATIENTS, HOW SIGNIFICANT THIS COMPONENT IS, IS REALLY IMPORTANT AND TO CINDY'S POINT ABOUT THE SUPPORT GROUPS PEOPLE FIND A LOT OF ALLEGIANCE, THEY GET VALIDATION THEY AREN'T CRAZY AND THAT THEY HEAR NEW IDEAS, YES OF COURSE, BUT THE PSYCHOLOGICAL COMPONENT OF IT I THINK FITS IN VERY STRONGLY WITH DR. COLLINS' EFFORTS. >> SORT OF RELATED TO THAT COMMENT I THINK IT'S, YOU KNOW, IMPORTANT FOR THE PUBLIC TO UNDERSTAND THE MIND/BODY RELATIONSHIP AND THAT WE'RE REALLY NOT TALKING ABOUT MIND AND SEPARATION OF BODY BUT THERE IS ESSENTIALLY AN INTERACTION AND THAT PAIN CONDITIONS, THOUGH THEY MAY NOT HAVE VISIBLE SIGNS AND SYMPTOMS EXTERNALLY, THERE'S AND UNDERLYING NEUROBIOLOGY, YOU KNOW, AS REAL AS ALZHEIMER'S OR ANY OTHER CNS DISEASE. I THINK PROMOTING THE UNDERSTANDING OF THE LACK OF SEPARATION BETWEEN MIND AND BODY AND THE FACT THAT THERE IS A NEUROBIOLOGY THAT UNDERLIES PAIN IS VERY IMPORTANT. AND WHETHER WE USE PSYCHOLOGICAL INTERVENTIONS, THEY ARE IN FACT WORKING ON THE SAME SYSTEMS, IF YOU WILL, OR SIMILAR SYSTEMS, AS ENDOGENOUS OPIOIDS WORK ON. SO THAT WE'RE INFLUENCING THE NEUROBIOLOGY OF THE BRAIN WHICH INFLUENCES SENSORY PERCEPTION. THAT SEEMS TO GET LOST, NOT ONLY TO THE PUBLIC BUT WITH MANY HEALTH CARE PROVIDERS, THAT, YOU KNOW, THESE INDIVIDUALS ARE PSYCHIATRIC PATIENTS AND NOT PATIENTS WHO HAVE SOME TYPE OF A MORE PERIPHERAL GENERATOR TO THEIR PAIN CONDITIONS. AND TRYING TO BREAK THROUGH THAT STIGMA IS I THINK VERY IMPORTANT. >> JUST A QUICK COMMENT, WHICH CHAD BROUGHT UP INITIALLY AND I THINK THIS AHRQ HAS THAT'S PUBLIC EDUCATION AND THAT YOU HAVE A RARE OPPORTUNITY WITH TRYING TO PUT TOGETHER THIS COLLABORATION OF GIVING THE PUBLIC A SNAPSHOT ON WHERE PAIN IS NOW AND WHERE IT NEEDS TO GO BECAUSE THAT WILL ALSO OPEN UP ALL SORTS OF FLOODGATES OF PEOPLE WHO WANT TO PARTICIPATE. NATIONAL GEOGRAPHIC DID THE SPECIAL ON ADDITION. DID ANYBODY SEE IT? IT WAS THE COVER STORY. EVERYBODY ON AIRPLANES WAS READING IT. THEY WERE THINKING ABOUT THE ISSUES. WE HAVE TO THINK ABOUT MOVING THIS DEBATE FROM A TABLE LIKE THIS TO WHERE PEOPLE START SAYING TO THEIR CLINICIANS, HOW CAN I MAKE SENSE OF WHAT'S GOING ON? SO JUST A PLEA. >> THIS IS REALLY GOOD. HOPEFULLY WE'LL HAVE MORE TO TALK ABOUT. MAYBE SOME MONEY BEHIND IT, WHICH WOULD BE GREAT. >> HI, I'M LEAH PORGORZALA, SCHEDULED FOR FIVE MINUTES, I'LL TAKE TWO SO YOU CAN CATCH YOUR PLANES. WE'VE BEEN WORKING FOR A LONG TIME TO REVAMP THE WEBSITE, NINDS REVAMPED THE WEBSITE. IT'S BEAUTIFUL. THE PAIN CONSORTIUM WEBSITE HAS ALSO BEEN REDONE. I JUST WANTED TO SHOW A COUPLE OF THINGS SO THIS IS OUR NEW WEBSITE. EVERYTHING, IF YOU LOOKED AT OUR OLD WEBSITE YOU KNOW THINGS WERE SCATTERED AND HARD TO NAVIGATE. WE THINK THIS ONE IS A LOT BETTER, AND WE'RE WORKING ON MAKING IT EVEN BETTER. SO IF YOU ALL WOULDN'T MIND, JUST CHECKING IT OUT, IF YOU HAVE ANYTHING THAT SHOULD BE ON HERE THAT'S NOT PLEASE LET ME KNOW. AND SO I JUST WANTED TO POINT OUT THAT THE IMPLEMENTATION -- I'M SORRY. THIS IS -- THAT'S NOT THE RIGHT ONE. IF YOU'RE LOOKING FOR THE NATIONAL PAIN STRATEGY IMPLEMENTATION GOALS, THEY ARE UNDER THE OBJECTIVE AND UPDATES, THEY NOW HAVE THESE NIFTY LITTLE COLLAPSING WINDOWS. AND AS ALICIA MENTIONED EARLIER, WE WILL BE UPDATING THESE AS SOON AS WE GET MORE INFORMATION. SO THIS IS ONGOING. THE FEDERAL PAIN RESEARCH STRATEGY, PLEASE SEND THIS LINK TO ALL OF YOUR FRIENDS AND ANYONE WHO MIGHT BE INTERESTED. YOU ALL HAVE THIS IN YOUR FOLDERS BUT WE'RE VERY PROUD OF IT. THAT'S ALL I HAVE UNLESS ANYONE HAS ANY SPECIFIC QUESTIONS. >> I HAVE A QUESTION. HAS THE LINK TO THE NATIONAL PAIN STRATEGY CHANGED, I'VE USED THAT LINK BEFORE. IS THERE A NEW LINK, A NEW PATH? >> A NEW LINK, YES. I'M SORRY, THAT'S THE OTHER THING. >> WE'LL HAVE TO UPDATE THAT STUFF. >> YES, THE MAIN PAGE IS STILL THE SAME IPRCC.NIH.GOV. IN FACT A LOT SHORTER NOW. >> THANKS. >> LINDA, IF WE'RE NEAR CLOSING I WANT TO THANK YOU SO MUCH FOR THE INCREDIBLE WORK YOU AND WALTER HAVE DONE, BRINGING BOTH THE FEDERAL PAIN RESEARCH STRATEGY AND NATIONAL PAIN STRATEGY TO A CLOSURE. IT WAS A HUGE, HUGE AMOUNT OF WORK. I MEAN, YOU'VE BEEN THERE ALL THE WAY WITH GUIDING THAT. THERE'S 80 PEOPLE ON PARKED ON BOTH PROJECTS, THEY ARE HUGE, BIG UNDERTAKING, THAT AND THE PORTFOLIO SETS US UP FOR SAYING, LOOK, HERE'S THE WORK READY TO DO ON A PLATTER. KNOW IF WE CAN GET THE FUNDING AND COMMON FUND PIECE, IT'S LIKING LIKE WE'RE GETTING REAL MOVEMENT. SO THANKS A LOT FOR ALL THAT YOU'VE DONE TO REALLY BRING US TO FRUITION. [APPLAUSE] >> OKAY. I WANT TO SAY ONE THING BEFORE WE GO. AT THE LAST MEETING WE HAD THE NATIONAL ACADEMY OF MEDICINE ON THIS TOPIC WE WENT THROUGH THINGS. AGAIN, WE HAD REPRESENTATIVES FROM CMS AND MEDICAID AT THE TABLE. AND THEY WERE VERY INTERESTED IN HELPING GET BETTER PAIN TREATMENT. SO IT WAS SHARI LING FROM CMS, SHE'S GREAT. AND THEN THE GUY FROM MEDICAID, HE SAID HE SPENDS 50% OF HIS TIME ON PAIN-RELATED WORK. >> WHERE ARE THESE PEOPLE? WHEN WE REACH OUT TO THEM WE HAVEN'T BEEN ABLE TO FIND THE PEOPLE WITHIN CMS. IN FACT CMS' OPIOID STRATEGY THE LAST PART HAD TO DO WITH SORT OF COVERING, YOU KNOW, MULTI-MODAL PROGRAMS, HAD NOTHING IN IT LIKE THEY DIDN'T HAVE -- THEIR OPIOID STRATEGY, THERE'S NOTHING IN IT. IT WAS BIZARRE. WE HAVEN'T BEEN ABLE TO FIND PEOPLE SUPPORTIVE MUCH THIS WHOLE PAIN ISSUE. >> THEIR NAMES WOULD BE ON THE ROSTER FROM THE NATIONAL ACADEMY OF MEDICINE ON OCTOBER 11th. I DON'T REMEMBER HIS NAME. >> YEAH, SURE. WE'D LOVE TO TALK TO THEM. >> THEY ARE BY REGULATION, THEY HAVE LOTS OF LIMITS ON WHAT THEY CAN DO. BUT THEY REALLY WANTED TO HELP. >> SO ONE FINAL NOTE BEFORE EVERYBODY LEAVES IS IN THE FEDERAL REGISTER NOTICE THAT THE MEETING IS COMING ALONG, WE PUT OUT A CALL FOR PUBLIC COMMENT. THAT'S A FACA REGULATION. WE NEED TO DO IT EACH TIME WE HAVE A MEETING. WE HAVEN'T HAD AN ORAL PUBLIC COMMENT FOR QUITE SOME TIME BUT I WANT TO LET YOU KNOW AT THE BACK OF YOUR PACKAGE PLEASE MAKE SURE YOU LOOK THROUGH THIS. THIS WAS A WRITTEN COMMENT THAT CAME IN. IT WAS APPROVED FOR YOUR PACKET. PROTECTING ACCESS TO PAIN RELIEF COALITION HAS SENT IN A THREE-PAGE SUMMARY OF MAJOR ACTIVITY THEY ARE INVOLVED IN AND THEY WANTED TO LET THE IPRCC KNOW ABOUT IT. SO PLEASE HAVE A LOOK AT THAT. >> NEXT MEETING IS NEXT WEEK. [LAUGHTER] >> WALTER. NO, I'M NOT SURE YET. WE'LL GET SOMETHING ON THE SCHEDULE. BUT THANK YOU ALL VERY MUCH. >> THANKS, EVERYBODY.