>> WE HAVE A PRETTY PACKED AGENDA. LOTS OF INTERESTING THINGS GOING GOING ON. NOT ONLY HERE TODAY, BUT ACROSS THE COUNTRY, IN THE AREA OF TRYING TO IMPROVE PAIN CARE FOR PATIENTS SO I WANT TO THANK EVERYONE FOR COMING. I THINK IT'S GOING TO BE AN INTERESTING DAY. FOR THOSE FLEW ON THE DIRECTORATE ON NINDS AND SERIES THE ELECTED CHAIR OF THE IPRCC AND I WORK FOR LINDA PORTER. [LAUGHTER] WHICH I AM VERY HAPPY TO DO, I MUST SAY. SO BEFORE JOINING NINDS. I WAS AT HARVARD MEDICAL SCHOOL, VICE-CHAIR OF THE NEUROLOGY DEPARTMENT THERE AND I SPECIALIZE IN CERTAIN AREA BUS I DID A LOT OF GENERAL NEUROLOGY AND TOOK CARE OF PATIENTS WITH CHRONIC PAIN, AS WELL. AND SO HAVE A SENSE OF WHAT THE PROBLEMS ARE FOR THE AFFECTED PAIN ON PEOPLE'S LIVES AND ALSO, AT NINDS, WORK WEALTH OTHER INSTITUTES HERE, MANY OF WHICH ARE INVOLVED IN PAIN RESEARCH, I THINK WE ALL HAVE A REAL STRONG APPRECIATION OF HOW MUCH NEEDS TO BE DONE TO BETTER UNDERSTAND PAIN AND TO IMPROVE HOW OUR HEALTH SYSTEM CAN PROVIDE CARE FOR PATIENTS WITH PAIN SO TODAY, WE HAVE SOME REALLY INTERESTING THINGS TO TALK B. WE FOCUS ON TWO IMPORTANT THINGS FOR IPRCC. ONE IS THE NATIONAL PAIN STRATEGY, WHICH YOU WERE INSTRUMENTAL IN DEVELOPING AND PASSING ALONG TO HHS. AND THEN THE FEDERAL PAIN RESEARCH STRATEGY, WHICH IS CURRENTLY ON GOING, IN ITS DEVELOPMENT AND I THINK IT'S GOING TO HAVE VERY IMPORTANT IMPLICATIONS FOR ALL THE FUNDERS OF PAIN RESEARCH, BOTH IN THE GOVERNMENT, OUTSIDE THE GOVERNMENT AND IN THE GOVERNMENT, AT NIH AND THE OTHER AGENCIES AS WELL. IN ADDITION, WE'LL HEAR FROM PENNY MOORE ABOUT THE EXTENSIVE PAIN RESEARCH INITIATIVES OF PE CORY. OUTCOME RESEARCH INSTITUTE AND FROM JOHNNY RUDER ON PAIN RELEVANT COMPONENTS ON THE PAIN INITIATIVE -- PAIN MEDICINE INITIATIVE. WE'RE REALLY PROUD THAT THE NATIONAL PAIN STRATEGY WAS RELEASED IN MARCH AND ASSISTANT SECRETARY FOR HEALTH APPROVED THE IMPLEMENTATION PLAN AND WE'LL SPEND THE MORNING WITH UPDATES AND PROGRESS TO THE IMPLEMENTATION MAN AND EARLY STEPS BY THE FEDERAL AGENCIES AND THE EXTERNAL STAKEHOLDERS, WHICH INCREASE SOME OF THE OBJECTIVES OF THE NATIONAL PAIN STRATEGY. MUCH OF THE AFTERNOON WE'LL FOLK FOCUS ON THE PERIOD PAIN RESEARCH STRATEGY, WHICH IS REALLY IMPORTANT, AS I MENTIONED, FOR NIH AND YOU KNOW THIS REPORT WILL ALIGN WITH THE IRM RECOMMENDATIONS TO IMPROVE PAIN RESEARCH ACROSS THE FEDERAL GOVERNMENT. IT ALSO FILL ACE MAJOR RESEARCH OBJECTIVES OF THE NATIONAL PAIN STRATEGY'S DEVELOPMENT WAS REALLY FOCUSED ON A STRATEGY FOR PROVIDING PAIN CARE AND NOT REALLY ON THE RESEARCH SIDE. THE RESEARCH SIDE IS REALLY, REALLY GATED TO THIS EFFORT THAT'S CURRENTLY ON GOING THE FEDERAL PAIN RESEARCH STRATEGY A LOT PEOPLE WORKED REALLY HARD ON THAT. SO GETTING UPDATES ON WHERE THAT IS. AND WHAT THAT'S GOING TO LOOK LIKE IS REALLY IMPORTANT. THERE'S A COUPLE OF BRIEF ANNOUNCEMENTS BEFORE WE START. THE NOMINATION SLATE FOR THE 2017 NEW IPRCC MEMBERS IS NOW OPEN. THERE ARE INSTRUCTION ON THE WEBSITE. CAN YOU GOOGLE IPRCC, IT'S AN NIH WEBSITE. WE HAVE OPENINGS FOR THREE PUBLIC, THREE SCIENTIFIC/CLINICAL MEMBERS IN 2017. SO REALLY IMPORTANT TO HAVE GOOD PEOPLE AROUND THE TABLE. PLEASE CONSIDER A NOMINATION PACKET FOR SOMEONE YOU THINK WOULD PROVIDE VALUABLE INPUT TO THE COMMITTEE NOW, YOU ARE A FEDERAL ADVISORY COMMITTEE AND UNTHAT ALL TOO L BECAUSE YOU'RE OBLIGATED TO FILL OUT CONFIDENTIAL 450 FORMS EACH YEAR YEAR. THESE ARE NECESSARY TO ENSURE THAT THE FOLKS WHO ARE ADVISING THE FEDERAL GOVERNMENT DO SO WITH ANY CONFLICTS OUT THERE IN THE OPEN, AND ALSO I MUST SAY THAT WE HAVE NO REASON TO EXPECT T BUT IF THERE ARE ISSUE THAT IS COME UP, IN WHICH YOU CAN BE PERCEIVED AS HAVING A CONFLICT CUE TO SOME FINANCIAL B YOU SHOULD RECUSE YOURSELF AND LEAVE THE ROOM DURING THAT DISCUSSION. WE DO THAT VERY COMMONLY WHEN, WE HAVE OUR MEETINGS AROUND GRANTS. SO IF YOU'RE FROM, YOU KNOW, UNIVERSITY OF WISCONSIN WITH US AND THERE'S A GRANT THAT'S GOING TO BE DISCUSSED ABOUT THE UNIVERSITY OF WISCONSIN WITH US THEN A NUMBER OF THE UNIVERSITY OF WISCONSIN WITH US WOULD LEAVE THE DURING THAT DISCUSSION AND WOULD COME BACK AFTER THE DISCUSSION ABOUT THE GRANT IS OVER. AND CAN YOU SEE WHY THAT WOULD BE IMPORTANT. BUT SIMILARLY HERE, UNFORTUNATELY, THE, WE UNDERSTAND THAT THERE IS A SIGNIFICANT BURDEN ON FOLKS TO GO THROUGHOUT REPORTING AND KITHE GLAZER, FOUNDER OF THE MIGRANT RESEARCH FOUNDATION WAS NOMINATED TO SERVE IN THE IPRCC BUT GIVEN ALL THE THINGS THE GOVERNMENT ASKED HER TO DO, SHE DECLINED TO SERVE. SO WE'RE REALLY DISAPPOINTED SHE WON'T JOIN US, BUT WE CERTAINLY UNDERSTAND THE REASONS AND IT'S NOT THAT UNCOMMON THAT THIS HAPPENS AND ALL OF YOU AROUND THE TABLE KNOW WHAT THE DEMANDS ARE FOR FILLING OUT THESE FORMS AND PUTTING YOUR INFORMATION. ALTHOUGH CONFIDENTIAL, TO THE GOVERNMENT. BUT IT IS CRITICAL. IT IS NECESSARY AND IT IS THE LAW FOR ANY ADVISORY COMMITTEE. IN THE LAST TWO YEARS, WE HAVE HAD SOME SLATE OF DELAY IN THE APPROVE A. WE SEE THE NOMINATIONS. BET THE NOMINATIONS AND THEN RECOMMEND FOLKS TO HHS AND THAT OFFICE AT HHS HAS TO GO THROUGH AND MAKE THE FINAL DETERMINATIONS AND AMOUNT OF TIME THAT TAKES IS VARIABLE. BUT WE DO HAVE SOME SLOTS THAT ARE NOT FILLED BUT WHAT WE DO IN THOSE INSTANCES IS ASK FOLKS TO BE ESPECIALLY PATIENT AND TO EXTEND THEIR TIME-OUT COMMITTEE SO THIS TIME, WE'D LIKE TO THANK ALLEN BUSBOW. PENNY KALEN FOR AGREEING TO REMAIN ON THE COMMITTEE TO ACCOMMODATE THE TRANSITION PERIOD AND THANK THEM IN ADVANCE FOR THE YEARS OF SERVICE TO THE COMMITTEE. THIS WILL BE THE LAST OPPORTUNITY TO DO SO IN PERSON BEFORE THEY ROTATE OFF THE COMMITTEE AND AS YOU KNOW, THEY ALL SPENT AN ENORMOUS AMOUNT OF TIME AND EFFORT TO GET THE COMMITTEE ON TRACK AND MOVING FORWARD AND THEIR INPUT AND EXPERTISE HAS REALLY HELPED US ON IPRCC. SO THANKS VERY MUCH, AL AND BILL AND PENNY. THANK YOU. [Applause]. PENDING MEMBERS. DAN CHAMBERS, DAN CARR, DR. FILLING HAM. MS. CHAMBERER CITIZEN FOUNDER AND PRESIDENT OF NATIONAL FIBRO MIAULINGIA FOUNDATION -- SHE HELPED COFOUND THE NATIONALIFIABLE ROW MYALGIA ASSOCIATION COALITION W GOAL OF BRINGING AWARENESS, POLICY CHANGES, AND BETTER ACCESS TO CARE FOR PEOPLE WITH IF I BROMYALGIA. OTHER FEDERAL EFFORTS, INCLUDING THOSE OF THE FDA. DR. CARR IS A PHYSICIAN AND PROFESSOR AT TUFTS UNIVERSITY SCHOOL OF MEDICINE WHERE HE CORRECTS EDUCATION AND POLICY, IT'S THE ONLY PROGRAM OF ITS KIND, BASED IN DIPLOMAT OF PUBLIC HEALTH AND COMMUNITY MEDICINE. AND DR. CARR HAS CONTRIBUTED HEAVILY TO THE NATIONAL PAIN STRATEGY, AS A MEMBER OF THE PROFESSIONAL EDUCATION WORK GROUP AND CO-CHAIR OF THE PREVENTION AND CARE GROUP. HE'S A CURRENT PERIOD OF THE AMERICAN ACADEMY OF PAIN MEDICINE. HE'S PUBLISHED EXTENSIVELY ON THE SOCIAL AND POLITICAL ASPECTS OF PAIN RELIEVE. INCLUDING THE AMERICAN PAIN SOCIETY'S 4-DICE. DISTINGUISHED IN SERVICE. AND HE CAN LENS IN EDUCATION AWARDS. AMERICAN ACADEMY OF PAIN MEDICINE. FOUNDER'S AWARD AND TWO CITATIONS FROM THE SECRETARY OF HHS. DR. FILLING HAM SAY PSYCHOLOGIST AND PROFESSIONAL PROFESSOR AT UNIVERSITY OF FLORIDA AND COMMUNITY DENTISTRY AND BEHAVIORAL SCIENCE WHERE HE DIRECTS THE PAIN RESEARCH OF EXCELLENCE. HIS RESEARC FOCUSES ON ETHNIC AND GENDER DIFFERENCES AND PAIN, IN RESPONSE TO MEDICINES. PRODUCTS RISK OF CHRONIC ORAL OR FACIAL PAIN. AND CONTRIBUTIONS TO PAIN SENSITIVITY, ANELGESIC RESPONSES AND CHRONIC PAIN RISK. HE HAS BEEN AN NIH GRANTEE FOR A LONG PERIOD OF TIME, PUBLISHED EXTENSIVELY. DR. FILLINGHAM SERVED AS PRESIDENT OF THE AMERICAN PAIN SOCIETY, AND IS RECIPIENT OF THE CLINICAL DICE RECIPIENT AWARD. I'D LIKE TO WELCOME THE NEW MEMBERS, AND THE OLD MEMBERS, TELL THEM ALL THE GOOD THINGS THAT HAPPEN ON THE COMMITTEE AND THE THINGS THAT TOUGH, THEY'LL 13 THOSE FOR THEMSELVES. [Applause]. NOW I THINK WOULD BE A GOOD TIME, ESPECIALLY SINCE WE HAVE NEW MEMBERS, AND PEOPLE LISTENING IN, T -- >> CHRISTINA SPELLMAN. EXECUTIVE DIRECTOR OF THE MAY DAY FUND. >> BILL MAX TER, DUKE UNIVERSITY, DIRECTOR FOR THE CENTER OF TRANSLATIONAL PAIN MEDICINE. >> SCIENTIFIC PROGRAM MANAGER DEPARTMENT OF VETERANS FAIRS. >> DAVE AS. NIDA. AND MEMBER OF THE NIH CONSORTIUM. >> MARTHA SUMMERMAN. DIRECTOR NATIONAL INSTITUTE OF CRANIAL AND FACIAL RESEARCH. >> CHAD HELLMICK WITH THE THAT'S PROGRAM WITH THE CENTERS OF DISEASE CONTROL AND PREVENTION. >> GOOD MORNING, RIC RICCIARDI. DIRECTOR OF THE DIVISION OF PRACTICE IMPROVEMENT AT THE AGENCIES FOR HEALTHCARE RESEARCH AND QUALITY. >> SHARON HERTZ. DIRECTOR FOR THE DIVISION OF ANESTHESIA, ANLAGESSA, AND ADDICTION PRODUCT IT'S FDA CENTER FOR DRUG EVALUATION AND RESEARCH. >> JUDY PACE. NORTHWESTERN IN CHICAGO. >> PENNY CAN, FOUNDER AND C.E.O. OF THE AMERICAN CHRONIC PAIN ASSOCIATION. >> [INDISCERNIBLE] HEALTHCARE RESEARCH OF MEDICAL SCHOOL IN [INDISCERNIBLE] MEDICAL CENTER. >> GOOD MORNING, MICHAEL PASTERNECKT. FOUNDING TRUSTEE OF THE PAIN FACIAL RESEARCH FOUNDATION. HAPPY HALLOWEEN. [LAUGHTER] >> ROGER [INDISCERNIBLE] UNIVERSITY OF FLORIDA. >> DAN CARR TUFTS UNIVERSITY. >> CINDY STEINBERG, NATIONAL DIRECTOR OF POLICY AND ADVOCACY FOR THE U.S. PAIN FOUNDATION, AND MASSACHUSETTS PAIN INITIATIVE. >> JOAN CHAMBERS. NATIONAL FIBRO MY -- >> JOSE BRIGGS. DIRECTOR OF THE NATIONAL CENTER FOR COMPLEMENTARY INTEGRATIVE HEALTH HERE AT NIH. >> ALLEN BETHSTONE, PROFESSIONAL AND CHAIR OF DEPARTMENT OF DEPARTMENT UNIVERSITY OF CALIFORNIA, SAN FRANCISCO. >> LINDA PORTER, PAIN POLICY, NIH . >> OKAY. GREAT. SO I'D LIKE TO DO AT EACH MEETING, INTERESTED IN TRYING TO SYNTHESIZE SOME ADVANCES IN PAIN RESEARCH AND IT'S COMPLICATED MATERIAL, BUT I THINK THE LEVEL OF UNDERSTANDING THE NERVOUS SYSTEM IS DEVELOP BEING AT A RAPID PACE AND IT'S COMPLICATED. THE COMPLEXITY OF THE NERVOUS SYSTEM IS REALLY UNLIKE ANY OTHER ORGAN IN THE BODY. BUT THEN TO, BUT THEN I THINK TO BE ABLE TO INTERPRET THIS KIND OF WORK AND ITS IMPACT, I THINK IS A REALLY IMPORTANT JOB FOR NIH FOLKS, AND I THINK ALSO, FOR EACH OF OUR ADVISORY COMMITTEES IN THEIR DIFFERENT AREAS. SO THE GROUP, LINDA AND SHERRIES AND LEAH, CARA PICKED OUT A COUPLE OF THINGS AND THESE ARE JUST PERFORMS THAT I SAID LET'S TALK ABOUT SOME ADVANCES AND SO I THINK THEY FIXED THE MOST COMPLICATED THINGS AND TO STRESS STRESS ME OUT TO, SEE IF I COULD EXPLAIN THESE THINGS AS WE GO FORWARD. SO THIS IS HOW WE DO. THIS IS A GROUP FROM THE PAPER, AND ALLICIN DISDISWAS PART OF THIS GROUP, SO THIS IS A VERY KIND OF YOU KNOW, VERY DEEP STUDY OF NEW TYPE OF SODIUM CHANNEL THAT THEY FOUND THAT, THEY THINK IS REALLY IMPORTANT IN MEDIATING PAIN SENSITIVITY. AND THIS IS A CHANNEL, YOU KNOW, IT'S BEEN INVOLVED IN EPILEPSY AND HEART FUNCTION. BUT NOT REALLY EVER GIVEN MUCH ATTENTION IN THE PAIN WORLD. AND THEY THINK IT'S IMPORTANT, IT'S IN A -- NUMBER OF DIFFERENT SENSORY CELLS AND GANGLION THAT MEDIATE PAIN. SO HERE'S A STAIN FOR THE SODIUM CHANNEL. CAN YOU SEE IT LIGHTS UP. CELLS ENDORSAL ROOT GANGLION. THEY SCREENED A WHOLE LIST OF TOXINS FROM DIFFERENT CREATURES, THE KIND OF CREATURE THAT IS COME OUT ON HALLOWEEN. LIKE TARANTULAS, FOR INSTANCE. AS WELL AS SPIDERS AND OTHER THINGS. THEY SCREEN THEM TO SEE WHAT TURN ON THE FIRING RACE OF THESE SENSORY NEW SPONSE THEY FOUND A TOXIN CALLED HM1A. AND THAT, ACTUALLY, THEY FIND ACTIVATES -- L INCREASES THE ACTIVITY OF THESE SODIUM CHANNELS SO YOU SEE THE FIRING FREQUENCY IN THE CELLS, ANY UP WHEN YOU ADD THE HOMA TOXIN. THE IDEA IS THEY FOUND A TOXIN THAT, ACTIVATES SODIUM CHANNELS, CAUSES FIRING RATES IN THESE CELLS. AND THEN WHAT'S THE KEEL WITH PAIN. WE MENTIONED DORSAL ROOT GANGLION CELLS ARE INVOLVED IN PAIN REMEDIATION. SO THEY INJECT THE POUR OF AN ANIMAL, A RODENT W TOXIN, WHAT WE FIND HERE IS HERE'S THE VEHICLE THEY JUST PUT IN SALT WATER. AND HERE'S THE TOXIN. WHAT YOU SEE IS IT IT CAUSE NOSAPENSIN BEHAVIOR. SO THE ANIMALS ARE SENSING PAIN WHEN YOU INJECT THE TOXIN. TO SHOW IT'S RETROSPECTIVELY TO THE SODIUM CHANNEL THEY HAVE A MUTANT ANIMAL WHERE THE SODIUM CHANNEL IS KNOCKED OUT. AND THERE YOU SEE THAT EFFECT IS REDUCED SO YOU KNOW THAT SODIUM CHANNEL, WHICH IS ACTSITIED -- OR INCREASED ACTIVATION BY THIS TOXIN S REALLY RESPONSIBLE FOR THE BEHAVIOR WHEN, IT'S INJECTED. THERE ARE MANY DIFFERENT TYPES OF DORSAL GANGLION ROOT -- IT'S VERY SPECIFIC FOR FOR ONE TYPE AND NOT OTHERS. SO MERE, CAN YOU SEE WHEN YOU LOOK AT THE RESPONSE TO HEAT, YOU DON'T SEE ANY DIFFERENCE WITH THE TOXINS. SO THESE CELLS ARE NOT MEDIATING PAIN SENSITIVITY TO HEAT. BUT INSTEAD, THEY SEEM TO BE SPECIFIC OR MUCH MORE SPECIFIC FOR MECHANIC RECEPTION. SO PAIN MEDIATED BY PRESSURE ON THESE MECHANO SENSITIVE ORGANS, SEEMS TO BE WHERE THE TOXIN IS RESPONSIBLE FOR, A CHANGE IN THE THRESHOLD TORQUE WHICH THE ANIMAL WILL PULL AWAY ITS POUR. AND THE EFFECT OF THIS TOXIN IS ON THIS CHANNEL, THAT'S RELATED TO THE MECHANICAL SENSE TEST. SO AN EXAMPLE OF AN IN-DEPTH STUDY, IDENTIFIATION NEW TYPE OF PATHWAY AT A MOLECULAR LEVEL, FOR PAIN SENSITIVITY PERIPHERY. THE INTERESTING THING IS THESE MEANINGFUL CANO-SENSITIVE CHANNEL -- THESE MECHANO-SENSE IF CHAINS, MEMBERSHIP BE IN PEOPLE WITH IRITIABLE BOWEL SYNDROME. SENSITIVITY OF COLONIC RECEPTORS AND PEOPLE WITH IRITIABLE BOWEL SYNDROME. AND IN THIS PAPER, THEY HAVE A MODEL, WHICH THEY SHOW, THOSE CELL THAT IS MEDIATE THAT ARE RUN OFTEN TIMES, OFF THESE SODIUM CHANNELS. SO I THINK THESE, YOU KNOW, WHAT WE'RE PRESENTING, I THINK ARE IMPORTANT FINDINGS. THE ISSUE FOR PEOPLE WITH CHRONIC PAIN IS HOW DOES THIS REALLY TRANSLATE. BUT I THINK HERE, THE ANSWER IS, TRYING TO GET MORE SPES SPECIFICITY IN HOW WE TREAT. WE GIVE SODIUM CHANNEL BLOCKERS FOR PEOPLE PEOPLE WITH PAIN. THEY GO OVER THE BODY AND THEY MAY NOT GET THE KOASES REQUIRED TO SHUT OFF THESE TYPE OF CHANNELS BECAUSE OF THE TOXICITY. BUT IF YOU CAN IDENTIFY WHICH CELLS, AND WHICH CELLS ARE IMPORTANT FOR PAIN, IT GIVE US YOU THE CLUE, IF YOU CAN GET A TREATMENT THAT'S THAT'S MORE SPECIFIC, EARTH THE WAY YOU ADMINISTER IT OR THE TYPE OF MOLECULE IT IS, HOW CELLS TAKE IT UP, YOU CAN POTENTIALLY MAKE ADVANCE. OKAY OKAY. SO THIS IS ANOTHER ONE. AND THIS IS AN INTERESTING PAPER FOR A NUMBER OF DIFFERENT REASONS. BECAUSE THING PAPER ILLUSTRATE THAT IS KIND OF INFORMATION WE HAVE AT THE MOLECULAR LEVEL, IS EXPLODED. PARTICULARLY WITH THE ADVENT OF CRYO ELECTRA MICROSCOPY. WELL, WE TALK ABOUT THESE CHANNELS. NOW, WE'RE GOING TO TALK ABOUT OPIOID RECEPTORS. RECEPTORS ON THE SURFACE OF THE MEMBRANE. AND YOU CAN -- THERE'S KNOW EXPLOSION OF RESEARCH, WHICH IS NAILING DOWN THE STRUCTURE RECEPTORS AT A MOLECULAR LEVEL. NOW, THE OTHER THING TO MENTION, THIS TYPE OF INFORMATION, ALTHOUGH IT'S ONE MOLECULE S INCREDIBLY COMPLEX AT THE MOLECULAR LEVEL. WHAT WE'RE TALKING ABOUT IS HOW TO MODEL NEW COMPOUNDS THAT CAN FIT INTO THIS RECEPTOR. WITH EQUATIONS THAT MODEL THE PHYSICAL INTERACTION BETWEEN THE RECEPTOR AND MANY DIFFERENT AT ONLIES THAT ARE GOING TO BE IN THE MOLECULES WE TALK ABOUT AND THE COMPUTATIONAL COMPONENT IS GIGANTIC. THESE ARE NOW, NOW WE CAN BRING SUPER COMPUTERS TO THE FIELD TO, TRY AND IDENTIFY WHAT TYPE OF COMPOUNDS WE REALLY NEED TO HAVE MUCH MORE EFFECTIVE PAIN MEDICINE. NOW THIS STUDY IS RIGHT DOWN THALY OF WHAT WE'D LIKE TO D. HERE'S A SCHEMATIC OF WHAT WE THINK IS GOING ON THE NEW OPIOID RECEPTOR, THAT IT BINDS TO A RECEPTOR, THAT IT CAUSES AN INCREASE IN CYCLIC AMP AND IT OPENS POTASSIUM CHANNELS AND THAT IS RESPONSIBLE FOR THE ANLAGESSIA. BUT THAT IS NOT THE ONLY THING THAT HAPPENS BECAUSE DOWN STREAM FROM THAT, IT RECRUITS A MOLECULE CALLED BETA ARRESTIN TO THE SURFACE AND BRINGS THE RECEPTOR OFF THE MEMBRANE AND THIS PROCESS WE THINK IS RESPONSIBLE IN SOME PART. FOR THE RESPIRATORY DEPRESSION AND TALENTS THAT DEVELOP TO OPIOID-BASED I DIDN'TS OVER TIME. FOR A LONG TIME, PEOPLE TRY TO FIND A DRUG THAT DOES THIS SIDE OF THE STORY, BUT NOT THIS SIDE OF THE STORY. I SAID IT WAS COMPLICATED. AND THESE THE EQUATIONS, NOT THE PICTURES. SO THEY HAVE THE STRUCTURE OF THE RECEPTOR. AND THEY KNOW KIND OF WHERE THE MOLECULES THAT AFFECT THE RECEPTOR DOCK AND THAT'S WHAT YOU SEE IN YELLOW. HERE, THEY SCREEN 3 MILLION COMPOUNDS AGAINST RECEPTORS. IN THE OLD DAYS, HAVE YOU TO DO AN EXPERIMENT, ONE AFTER THE OTHER, AND YOU MIGHT GET TO 20 OR 50. BUT HERE, WITH THESE COMPUTATION MODELS. YOU GET TO SCREEN, YOU KNOW, MILLIONS OF MOLECULES. 3 MILLION MOLECULES, AND FOR EACH MOLECULE, THERE'S ALWAYS DIFFERENT INTERACTION THAT IS GO ON AT THE BINDING OF THE MOLECULE TO THE RECEPTOR AND THEY WERE ABLE TO INVESTIGATE 1.3 MILLION CONFIGURATIONS FOR EACH OF THESE 3 MILLION COMPOUNDS. THAT'S WHERE THE COMPUTATIONAL PIECE COMES IN. THIS IS SOMETHING THAT IS COMPLETELY NOT DOABLE, PRIOR TO HAVING THE STRUCTURAL INFORMATION AND THE COMPUTATIONAL ABILITIES. THEY FOUND A COLPOUND THAT LOOKED LIKE IT WAS DOCKING NICELY, THEN THEY ACTUALLY, THEY REFINE THAT COMPOUND BECAUSE IT DIDN'T BIND VERY WELL. K.I. WAS 2.5 MICROMOLAR. BUT THEN THEY BASICALLY IN SIMULATIONS, CHANGED THE COMPOUND AROUND T. GET ANOTHER COMPOUND THAT, LOOKED A LITTLE BIT LIKE THE ONE THEY STARTED WITH. THAT HAS MUCH BETTER BINDING AIN'TS DOWN TO 32 NANOMOLECULEER, COMPARED TO 2.5. THEN YOU LOOKED AT THE TWO SEPARATE PATHWAYS. SO THE G.I. ACTIVATION WE THINK IS RELATED TO THE ANESTHESIA CAN YOU SEE THE COMPOUND IS REALLY QUITE GOOD FOR ANESTHESIA. BUT DOES HARDLY ANYTHING TO THE BETA ARREST INRECRUITMENT. HERE, YOU HAVE IN CELL CO, THEN TESTED, EXPERIMENTALLY, TO GET YOU WHAT YOU WANTED TO START WITH SO HERE'S THE VEHICLE. THERE'S NO ANLAGES YEAHSIAIA AND HERE'S THE DIFFERENT CONCENTRATIONS OF THE COMPOUND AND HOT PLATE MODEL OF ANALOGIESIA. IN TERMS OF RESPIRATORY DEPRESSION, I'M NOT SURE YET VEHICLE IN THIS MODEL CAUSES RESPIRATORY DEPRESSION. MORPHINE IS REALLY BAD IN THE VEHICLE AND THIS NEW COMPOUND IS PRETTY MUCH SANE IT MIGHT BE THE CARRIER THAT'S IN THERE OR SOMETHING. BUT ANY WAY, AND THEN THE LAST POINT IS THAT IF YOU COMPARE, YOU KNOW, WE TALKED ABOUT BEFORE, WHICH IS A PERIPHERAL ACTION AND PULLING THE PORT AWAY, THAT THIS COMPOUND IS VERY LITTLE EFFECT ON THE REFLUX COMPONENT -- I'M SORRY. ON THE EFFECTIVE COMPONENT, BUT MUCH MORE ON THE REFLEXIVE COMPONENT. OF THE ANLAGESSIA AN EXAMPLE OF AGAIN, SOMETHING THAT'S REALLY FORWARD LOOKING, THERE ARE COMPOUNDS THAT ARE IN TESTING THAT ARE SOMEWHAT SIMILAR TO THIS ONE. THIS ONE IN THE PAPER, MAY HAVE PROPERTIES, BETTER THAN THE ONE THAT IS HAVE BEEN TESTED I THINK IT DOES SHOW A PATHWAY FORWARD, TOO WHERE WE WOULD LIKE TO GET AT THE END OF THE RAINBOW, WHICH IS A DRUG THAT HAS THE ANLAGESSA PROPERTIES LIKE MORPHINE D. BUT SENT HAVE THE SIDE EFFECTS, AND PRESS PTORY DEPRESSION LEAD SAYS TO DEATH AND SHOCK IN PATIENTS WHO OVER DOSE. AND TELL TOLERANCE TO, A BIG PROBLEM IN TERMS -- CLARAINS IN TERMS MORE AND MORE TO GET THE SAME EFFECT. AND THE LAST ONE IS AN EXAMPLE OF USE OF SOME OF THE NEW TECHNOLOGIES, TOO TRY RESPOND HOW THESE CIRCUIT IT IS, VERY COMPLICATED CIRCUITS ARE FUNCTION NEGLIGENT BRAIN. AND MANY OF THESE TECHNOLOGIES ARE THE KIND OF THINGS THAT COMING OUT OF THE BRAIN INITIATIVE, WHICH IS DEVELOPING TOOLS, WHICH WILL ENABLE US TO LOOKING AT CIRCUIT ACTIVITY IN THE PAIN AND TO MODULATE THAT BRAIN ACTIVITY. SOME OF THE TOOLS FUNDED BY THE BRAIN INITIATIVE, WE LOOKING AT IN THIS PAPER TO, LOOKING AT CELLS AND THE NUCLEUS INCUMBENTS, A STRUCTURE THAT IS IMPORTANT IN KIND OF REWARD AND NEGATIVE AFFECT FOUNDATION OF OUR BEHAVIORS. SO THIS IS THE EFFECTIVE COMCOMPONENT OF PAIN. SO THEY HAVE THIS MODEL, WHERE THEY TIE OFF THE PER ANTIVIAL NERVE AND ANIMALS DEVELOP A CHRONIC PAIN SYNDROME OVER TIME. WHAT THEY CAN DO NOW IS WITH GENETIC TECHNIQUES. THEY CAN LABEL, SPECIFICALLY, THE TYPE OF CELLS IN A NUCLEUS INCUMBENT. TURNS OUT -- AND THIS IS PROBABLY OVER SIMPLIFY T. I'M NOT AN EXPERT ON THIS PART OF IT -- BUT FROM WHAT THE PRESENTATION IS, THERE ARE BASICALLY TWO PATHWAYS TO THE INCUMBENT. ONE IS INDIRECT PATHWAY AND OTHER IS DIRECT PATH WAY. THEY'RE INVOLVED IN DIFFERENT ASPECTS OF BEHAVIOR. THE TRENT PATHWAY, MORE INVOLVED IN THE KIND OF REWARD AND POSITIVE ASPECTS OF BEHAVIOR. THAT'S HOW I UNDERSTAND IT. WITH THE NEW TECHNIQUES, CAN YOU LABEL ONE RED AND ONE GREEN, THEN YOU KNOW WHICH ONE YOU'RE DEALING W THEY BASICALLY PROBLEMS IN DIFFERENT AREAS. HAVE YOU TECHNIQUES YOU CAN BASICALLY LIABILITY CELLS. OTHERWISE, YOU GO IN AND YOU DON'T KNOW WHICH CELLS YOU'RE STUDYING. BUT NOW YOU CAN ACTUALLY LABEL THEM SPECIFICALLY. AND THERE ARE PEOPLE WORKING ON GUYS TO DO THIS. ROGER CHEN, WHO WAS NOBLE PRIDES LAUREATE, JUST DIED, UNFORTUNATELY, A COUPLE OF MONTHS AGO. BUT HE WAS THE CHAMPION OF DEVELOPING THESE, CAN WE PUT INTO NEW SPONSE IDENTIFY THEM. SO WHAT YOU SEE IF YOU THEN GO IN AND RECORD FROM THESE CELLS, THE RED AND THE GREEN ONCE, YOU'RE INTERESTED IF HERE IN THE GREEN ONCE YOU SEE THAT WHEN YOU CAUSE THIS MODEL OF PAIN. -- IN THESE GREAT INDIRECT PATH NEURONS, INVOLVED IN THE NEGATIVE ASPECTS OF BEHAVIOR. WHEN YOU GO IN AND EXAM THE MORPHOLOGY OF THESE CELLS, THEY HAVE CHAFE CHANGED. SO THIS IS A PLOT WHERE YOU BASICALLY HAVE CIRCLES AROUND THE CELL BODY AND YOU JUST COUNT THE NUMBER OF BRANCHES THAT, YOU KNOW, CROSS MULTIPLE, DIFFERENT ZONES AS AWE MOVE OUT. WHAT THEY FIND IS THAT IN THE ANIMALS WITHOUT THE CHRONIC PAIN SITUATION, THEY HAVE FAIRLY ROBUST BRANCHING. BUT THAT IS DECREASE BY THE THE PAIN. SO AN EXAMPLE OF THE PLASTICITY, GOING INSIDE THE BRAIN, WITH A CHRONIC BRAIN MOD KNELT LEG. THEN WHAT THEY ALSO DO, THEY MEASURE, BECAUSE THE INCUMBENT IS RECEIVING DOPAMINE FROM THE VTA NUCLEUS AND THAT DOPAMINE PROJECTION IS REALLY IMPORTANT IN THE REWARDS SYSTEM. WHAT THEY FIND IS THAT IN THE -IN-THE- MODEL OF PAIN, YOU HAVE LES DOPAMINE IN THIS AREA OF THE NUCLEUS -- WHERE HAVE YOU THIS CHANGE IN THE BRANCHING AND HAVE YOU AN INCREASE IN THE FIRING SO THEY'RE REALLY GETTING INTO THE DETAILS OF WHAT'S HAPPENING IN CIRCUIT. AND HERE, YOU SEE THE DENDRITIC CHANGE. BUT HERE, IN THE MODEL. THE DENDRITIC LENGTH WAS DECREASED. TURNS OUT F YOU GIVE L-DOPER PAY PROXIMATEN, CAN YOU GET THE DENDRITIC LANE -- LOOKS LIKE THE DOPAMINE AND THE PAIN PATHWAYS ARE REALLY F BLOCK THEM, INCREASE THE DOPAMINE, GIVE NAPROXEN AND YOU CAN ACTUALLY CHANGE DENDRITIC LENGTH GAIN. IF YOU LOOKING AT THRESHOLD TO STIMULATION. YOU CAN AGAIN, NORMALIZE THAT WITH INCREASED DOPAMINE AND NAPROXEN. AND THIS IS MEDIATED THROUGH WHAT THEY THINK IS A D-2 RECEPTOR. SO IT KIND OF GETS TO THE POINT THAT THIS IS POTENTIALLY MODIFIABLE BY DRUG THAT IS WE HAVE, WHICH CAN INCREASE ACTIVATION OF DT RECEPTOR. YOU SHOULD BE ABLE TO SEE IMPROVEMENT F YOU HAD THIS IN A PATIENT. IMPROVEMENT IN THE PAIN SITUATION. SO THEY'RE USING NEUROPHARMACOLOGY TO REVERSE AN ABNORMALITY THEY SEE IN A PAIN SITUATION. NOW, THE COOL THING IS THAT EVERYTHING IS PRETTY MUCH THE NEARY, THEOCRATICAL BASIS BEHIND THIS IS STILL ASSOCIATIVE. YOU'RE SEEING CHANGES ASSOCIATED WITH XY AND Z AND IS IT REALLY CAUSAL. L THERE'S A NEW KNEW TECHNOLOGY, CALLED CHEMO GENETICS. SO IN CHEMO GENETICS. YOU CAN PUT A GENE IN THOSE GREEN CELLS AND THAT GENE HAS CODE 3 RECEPTOR THAT, GOES INTO THOSE GREEN CELLS AND THOSE RECEPTORS HAVE BEEN ENGINEERED TO EITHER TURN ON OR TURN OFF THE NEURONS. THE WAY THEY TURN THEM ON OR OFF IS THESE RECEPTORS BIND TO A CHEMICAL WHICH HAS REALLY NO OTHER ACTIVITY IN THE BODY, EXCEPT IN THIS VERY KIND OF ENGINEERED, ART OFFICIAL SYSTEM. SO NOW INSTEAD OF PUTTING ELECTRODE IN, AND STIMULATING THE NEURONS, YOU CAN PUT TEDE VIRALLY INDUCE THESE CELLS, THESE GREEN CELLS WITH THESE CHEMO GENETIC PROBES AND BY GIVING THE ANIMALIA PILL. YOU CAN TURN ON OR TURN OFF THE CELLS, DEPENDING ON WHICH GENE YOU PUT IN. THEY HAVE GENIUS THAT TURN ON THE CELLS AND GENIUS THAT TURN OFF THE CELLS. CAN YOU GET THE CAUSALITY. SO THAT'S WHAT THEY DID. WHEN THEY GIVE THIS MOLECULE P HAS NO OTHER AFFECT, EXCEPT IN THE CELL THAT IS HAVE THIS RECEPTOR. NAVE THE EXCITATORY RECEPTOR AND THEY CAN SEE A CHANGE AND THEY CAN SEE THE OPPOSITE CHANGE. SO ON THE ANIMAL SIDE YOU CAN SEE JUST HOW POWER. THIS. THE ABILITY TO IDENTIFY THE VISUALITY, IDENTIFY THE CELLS, FIND OUT WHAT THEY'RE DOING AND THEN TURN THEM ON OR TURN THEM OFF AT WILL, USING THESE GENETIC MODELS. SO IT REALLY GETS YOU AT CAUSALITY IN TERMS OF THE CIRCUITS FOR PAIN. WILL THIS EVER HAPPEN IN PEOPLE? I THINK IT WILL. I THINK THE CHEMO GENETIC TECHNIQUES ARE THE KINDS OF THINGS THAT CAN GET TO PEOPLE EARLY ON. THEY ARE PUT INTO A VIRAL VECTOR AND THAT'S ALWAYS A BIG CONCERN THAT YOU NEED TO INCORRECT THEM INTO THE BRAIN AT THIS POINT. WE ARE FUNDING STUDIES, AND VERY SAFE DISEASES. KIDS GORGE DIE AND WE ARE INVESTIGATING INJECTING HAVE I VIRUS THAT IS HAVE THE GENE THAT THESE KIDS NEED, TOO TRY TO REVERSE THIS DISORDER. SO THAT'S GOING ON. SO VIRAL DELIVERY IS GOING ON. AND THERE ARE INTERESTING WAYS IN WHICH YOU MIGHT BE ABLE TO DELIVER THE VIRUS, WITHOUT HAVING TO PUT A NEEDLE INTO THE BRAIN. SO THERE'S A TECHNIQUE CALLED FOCUS ULTRASOUND. YOU CAN DIRECT A SOUND WAVE BEAM TO A VERY SMALL AREA OF THE BRING A 1MM SPOT, AND THAT WILL OPEN THE BLOOD BRAIN BEARER. SO IF YOU INJECT SOMETHING AT SAME TIME YOU GATE ULTRA SOUND, IT'LL JUST GO TO THAT SPOT. SO THESE ARE KIND OF FORWARD THINKING IDEAS BUT ACTUALLY ALL THE THINGS I MENTIONED ARE FUNDED OUT OF THE BRAIN INITIATIVE. BUT THESE TECHNOLOGIES ARE GOING TO BE GAME CHANGERS FOR PAIN RESEARCH. AND ALREADY, I THINK WE CAN SEE AN UNDERSTANDING, IF NOT, THE TREATMENT IS ALREADY BENEFITED. I WANTED TO THROW THOSE OUT F. PEOPLE WANTED TO COMMENT ON THIS OR OTHER AREAS AND CERTAINLY, PEOPLE HAVE SUGGESTIONS FOR WHAT THEY'D LIKE TO HEAR ABOUT AT THE NEXT IPRCC MEETING, I'D BE HAPPY TO GET INPUT. SO THANKS VERY MUCH. [Applause]. WE ASK AFTER EACH MEETING THAT, MINUTES THAT WE HAVE ALREADY PUBLICLY POSTED WITHOUT YOUR APPROVAL. THAT YOU REVIEW THEM AND GIVE US AN APPROVAL WHEN YOU PUT THE OFFICIALLY APPROVED MINUTES. SO THESE HAVE BEEN UP HERE FOR QUITE SOME TIME. FOR THOSE WHO WERE HERE AT DECEMBER THIRD MEETING LAST YEAR THERE WAS A LOT OF PUBLICITY RETROSPECTIVELYD TO THE MINUTES. THESE OF COURSE HIGHLY SCRUTINIZE. I KNOW YOU PROBABLY HAVEN'T SEEN THESE IN DETAIL. WE GIVE YOU A COUPLE MINUTES THAT YOU CAN LOOK THROUGH QUICKLY AND SEE IF YOU CAN SITE ANY PROBLEMS OR PLACES. WE NEED REVISIONS. WE'D APPRECIATE THAT. (PAUSE). 1 EVERYTHING NEED MORE TIME? CAN YOU HAV.>> SO MOVED. ALL THOSE IN FAVOR, SAY "AYE." [AYES] OKAY. WE HAVE OUR OFFICIAL VOTE FOR THE MORNING. WE HAVE DR. THOMAS NOVOTNY SCHEDULED TO SPEAK AT 9:30 AND I'M A LITTLE BIT WORRIED HE MIGHT BE ABSOLUTELY HELD UP. SO WHAT WE WILL DO, UNLESS HE SHOWS UP IN THE NEXT MINUTES OR TWO AND WE HAVE ASKED CATHERINE UNDERWOOD TO STEP INTO THE TIME SLOT AND WE'LL ADJUST AS DR. THOMAS NOVOTNY COMES -- HIGH, DID SOMEONE JUST JOIN OUT PHONE. >> HI, THIS IS CHRIS . >> CHRIS, YOU'RE GOING TO BE ABLE TO STAY ON FOR A WHILE. OKAY. WONDERFUL. THANK YOU. YOU HAVEN'T SEEN TOM THIS MORNING HAVE YOU? >> I HAVE NOT. OKAY. GREAT. WE'RE EXPECTING HIM IN A FEW MINUTES. SO I THINK WHAT WE'LL DO, WE'LL ASK KATHY UNDERWOOD TO STEP N. YOU ALL KNOW CATHY SO I'M NOT GOING TO INTRODUCE HER. SHE'S A MEMBER HERE. AND HE'S GOT SOME REALLY INCREDIBLY EXCITING NEWS ABOUT THE NATIONAL PAIN STRATEGY DR. THOMAS NOVOTNY IS DIRECTING THE IMPLEMENTATION OF THE NATIONAL PAIN STRATEGY. SO WHEN HE COMES, HE'LL GIVE YOU AN OVERVIEW IMPLEMENTATION PHASE WILL LOOK, ORGANIZATIONALLY AND STRUCTURALLY. THEY WEREN'T DUE UNTIL 9:30. SO THEY ARE ACTUALLY NOT LATE. OKAY. TOM. I'M WAITING FOR THE ELEVATOR TO GO UP TO THE CONFERENCE ROOM. [LAUGHTER] I'M SORRY ABOUT THIS. LET ME JUST GET THEM SETTLED AND WE'LL GET STARTED. OKAY. GREAT, THANKS, EVERYBODY FOR BEING PATIENT AND TO TOM AND ALICIA FOR MAKING A RUN UP HERE TODAY. BEFORE I INTRODUCE DR. THOMAS NOVOTNY, I WANT TO TAKE A MINUTE TO RECOGNIZE SOMEONE WHO'S BEEN A VERY KEY PLAYER SO FAR IN THE IMPLEMENTATION PROCESS AND I'M WILL BE THROUGHOUT THE FUTURE. SO ALICIA RICHMAN, WHO IS SIT ATHTHE CORNER OF THE TABLE THERE ALICIA RICHMAN SCOTT, ACTUALLY, SHE JOINED DR. NOVOTNY'S OFFICE. SHE BRINGS AN IMPORTANT VIEWPOINT TO THIS PROBLEMS AND? HER PAST, AND CURRENT EXPERIENCE THROUGH HHS. SHE'S WORKED ON SOME REALLY HIGH-LEVEL, AND VERY IMPORTANT INITIATIVES. INCLUDING THERE ARE MANY OTHERS. THE BEHAVIORAL COORDINATING COUNCIL, WHICH SHE'S WORKING ON AT SAME TIME, AS THE NTS. AND STEP TUP, THE SURGEON GENERAL'S CALL TO PROMOTE WALKING AND WALKABLE COMMUNITIES, AND SHE SERVED AS THE DIRECTOR OF OFFICE OF ADOLESCENCE PREGNANCY PROGRAMS. WE WANT TO RECOGNIZE HER EFFORTS WITH GETTING THE IMPLEMENTATION OF THE NPS OFF THE GROUND. THANKS VERY MUCH, ALICIA FOR COMING AND FOR ALL YOUR HELP SO FAR. SO DR. NOVOTNY Y DEPUTY SECRETARY ASSISTANT ANT -- FRESH 1992 TO 2002 AS DEPUTY ASSISTANT SECRETARY FOR INTERNATIONAL AND REFUGEE HEALTH AND ASSISTANT SURGEON GENERAL HE WANT SPENT 23 YEAR IN THE COMMISSION COURSE PUBLIC CORPS OF THE PUBLIC HEALTH SERVICE, INCLUDING AS A FAMILY PHYSICIAN IN CALIFORNIA, AS A CDC EPIDEMIC INTELLIGENCE SERVICE OFFICER, EPIDEMIOLOGY IN THE OFFICE OF SMOKING AND HEALTH AND CKC LIAISON TO UC BERKELEY SCHOOL OF PUBLIC HEALTH AND CDC LIAISON TO THE WORLD BANK IN WASHINGTON. HE'S ALSO BEEN AN EDITOR AND CONTRIBUTOR TO SEVERAL DIFFERENT REPORTS OF THE SURGEON GENERAL, PARTICULARLY ON SMOKING AND HEALTH. AFTER RETIRING FROM THE COMMISSION CORPS IN 2002, HE DIRECT AN INTERNATIONAL PROGRAM FOR HEALTH SCIENCE STUDENTS AND CONDUCTED RESEARCH FOR THE UCS CENTER FOR TOBACCO RESEARCH AND EDUCATION HE WANT LATER BECAME CO-DIRECTOR OF THE Ph.D. OF GLOBAL HEALTH AT SAN DIEGO STATE UNIVERSITY WITH A RESEARCH FOCUS ON GLOBAL HEALTH DIPLOMACY TOBACCO AND NONCOMMUNICABLE DISEASES -- COEPIDEMICS OF TOBACCO AND INFECTIOUS DISEASES SO HE COMES BACK TO HHS WITH AN INCREDIBLE BACKGROUND AND INCREDIBLE FAMILIARITY WITH THE ISSUES AND A LOT ENERGY AND ENTHUSIASM FOR THE NATIONAL PAIN -- . TOM? >> THANK YOU ANOTHER A PLEASURE TO BE HERE AND HAPPY HALLOWEEN, EVERYBODY. I DON'T KNOW IF ANYONE'S PLAN ON GOING DOWN TO GEORGE O GEORGETOWN. BUT MY RECOLLECTION THEY'RE USED TO BLOCK M STREET, AND MAKE IT A FRIGHTENING ENVIRONMENT F. HAVE NOTHING TO DO TONIGHT, YOU MAY BE ATTEMPTED BY BY THAT. AND THANKS FOR INVITE MING THIS MORNING. I HAD A LITTLE TROUBLE GETTING HERE. THEY DIDN'T GET HE'S CAR FROM HHS SO I DO L DROVE MYSELF, THANK GOODNESS FOR CELL PHONE TECHNOLOGY AND AIMING THINGS THAALLOW YOU TOFIGURE OUT THINGS. ALICIA MADE IT HERE, TOO. AND SHE WAS EQUALLY CHALLENGED BY OUR METRO SYSTEM AND PRODUCTION ON THE NORTH-SOUTH ARTERIES THAT CONTROL OUR TRAFFIC. SO I'M PLEASED TO BE BACK IN GOVERNMENT. YOU KNOW I THINK THE OPPORTUNITY TO BE IN PUBLIC SERVICE IS SOMETHING I ENCOURAGE ENCOURAGED ALL OF MY STUDENTS TO DO WHEN I WAS IN THE ACADEMIC REALM. IT'S A REAL GIFT ANOTHER A CHALLENGE. IT'S GOING TO BE MORE CHALLENGING COMING UP SHORTLY. BUT IT'S SOMETHING THAT MAKES A PERSON FEEL CONNECTED TO HIS PROFESSION, TOO HIS COUNTRY TO LOTS OF OTHER COLLEAGUES AND PROFESSIONALS AROUND, YOU KNOW, OUR PUBLIC HEALTHY ENVIRONMENT. AND THIS NATIONAL PAIN STRATEGY IS SOMETHING THAT HAD BEEN LANGUAGE WISHING, SITTING AROUND FOR THREE YEARS, I THINK YOU ALL KNOW THE STORY ABOUT THIS. WHEN I GOT MERE IN GENERAL, THEY SAID, OH, LET'S GET THIS OUT AND YOU KNOW, EASIER SAID THAN DONE KIND OF PROCESS, IT WAS AN INTERESTING SET OF TIMING EVENTS, AS WELL. I'LL MENTION THIS LATER. BUT WE LIVE IN PAIN IN AMERICA. THAT WAS THE IOM REPORT, THE BASIS FOR THIS AND THE GOVERNMENT'S FIRST BROAD RANGING EFFORT TO PURSUE HOW PAIN IS SERRY SEED AND STRESSE STRESSED AND TREATED. IT WAS RELEASED BY THE OFFICE OF THE ASSISTANT SECRETARY, DESALVOIN MARCH, WITH EVERYBODY'S HELP GETTING IT OUT THE DOOR. ON A FRIDAY AFTERNOON, WHICH ISN'T ALWAYS THE MOST SORT OF NOTE WORTHY TIME TO PUT OUT A GOVERNMENT DOCUMENT. THE CDC ISSUED ITS GUIDELINES ON OPIATE PRESCRIBING, WHICH WE'RE NEEDED, WERE COLORFUL NEEDED AS A WAY OF STABILIZING THE OPIOID OVER PRESCRIBING EPIDEMIC AND THE MISTAKES THAT WERE MADE. SOME OTHER THINGS THAT HAVE HAPPENED, THAT MADE IT SO WE CANNOT GET AS MUCH PLAY, ON THE RELEASE OF THE PAIN STRATEGY. BUT NEVERTHELESS, THAT ALLOWED THIS PROCESS TO MOVE FORWARD N TERMS OF IMPLEMENTATION. THE PAIN STRATEGY WAS MORE OF A PLAN TO PLAN. SO NOW, THE PLANNING IS MORE FORWARD GOING. SO SO THE LEAD FOR THE COORDINATION OF IMPLEMENTATION IS IN MY OFFICE. AND MY OFFICE IS A SOURCE FOR UNFUNDED MANDATEDS BUT NEVERTHELESS, WE WORK ACROSS DEPARTMENTS, OR ACROSS AGENCIES, WITH THE OFFICE OF ASSISTANT SECRETARIES TO GET THINGS TO HAPPEN. I'M NOT AN EXPERT IN PAIN. I AM, YOU KNOW, COGNIZANT OF THE ISSUES. I TOOK CARE OF PATIENTS FOR MANY YEARS, RESPOND THE CHALLENGE THAT INCLUDES ARISE IN TERMS OF CHRONIC PAIN. AND WE HAVE SET THIS UP TO REFLECT ON SOME OF THE THINGS WE'VE BEEN DOING. WE HAVE COORDINATING COUNCIL. WHICH WAS HELPED BY CHRISTINA -- ALICIA STEPPED UP TO KEEP THE BACC ON TRACK AS WELL. AND I THINK IT PROVIDES AN EFFECTIVE STRUCTURE FOR BROAD AND LARGE-SCALE INITIATIVES LIKE THIS. SO IT INVOLVES PRINCIPLES' COORDINATING COUNCIL, AND THIS IS WHERE DR. DESALVEO AND PEOPLE LIKE MOTA AND ADMINISTRATOR THERE, ARE THE CHAIRS AND THE PRINCIPLES FROM OTHER AGENCIES BECOME PART OF THIS. AND THIS IS WHERE THE GUIDING IMPLEMENTATION OCCURS SO THAT YOU KNOW, IF RESOURCES ARE NEEDED TO MOBILIZE PERSONNEL AND ACTIVITIES, THEY COME FROM A HIGH ENOUGH LEVEL TO MAKE THAT HAPPEN. MOSTLY ON POLICY DIRECTION AND ALSO, SETTING THE STAGE FOR EVALUATION AND SETTING FUTURE PRIORITIES AS A RESULT OF THE IMPLEMENTATION THAT GETS INTO PLACE. SO THE COUNCIL CAN DIRECT RESOURCES AND IT CAN ALSO HELP REALLY ENFORCE THE GOALS AND OBJECTIVES OF THE MPAS. AND THIS IS KIND OF THING THAT CARRIES OVER INTO THE NEXT ADMINISTRATION. YOU KNOW, WE INTEND TO DO THAT. I AM NOT A POLITICAL A POINT E, SO I GET TO SAY, I ASSUME AND HOPEFULLY, WE'LL CONTINUE TO MAKE SURE THIS MOVES FORWARD, EVEN NOT PRINCIPLES ARE ALL IMPLEMENTAL A POINT ES AND THEY WILL NOT BE HERE. THE COUNCIL MEETS TWICE A YEAR. AND THE PRINCIPLES PROVIDE FEEDBACK AND RECOMMENDATION TO THE WORKING GROUPS THROUGH A STEERING COMMITTEE. SO THE STEERING COMMITTEE ARE PEOPLE LIKE MYSELF, LINDA PORTER WHO DIRECT THE STEERING COMMITTEE. THIS IS WHERE THE WORK GETS DONE AS A RESULT OF THE PRINCIPLES' GUIDANCE, AND OF COURSE, LINDA HAS WORKED WORKED WITH ALL OF THE REPRESENTATIVES OF THE AGENCY AND THE DEPARTMENTS, ON THE DEVELOPMENT OF THE REPORT SO SHE HAS SUCH GREAT TREMENDOUS KNOWLEDGE, AND THE PERSONALITY AND PATIENTS AND DIGNITY TO MAKE THINGS HAPPEN ANOTHER JUST A PLEASURE TO WORK WITH SOMEONE LIKE LIND A. YOU KNOW, YOU REALLY MAKE IT NICE TO COME BACK INTO GOVERNMENT. SO THANKS A LOT YOU FOR THAT. SOME PEOPLE ASK SHE, YOU KNOW, WHAT ARE DOING? YOU LIVED IN SAN DIEGO N THIS NICE, SUNNY SPOT. WELL, YOU KNOW, THERE'S GOOD REASONS TO DO THAT AND A LOT THEM ARE BASED ON PEOPLE THAT ARE STILL HERE. THEY REALLY ARE. >> THE STEERING COMMITTEE THEN IS WHAT WE CHAIR. AND THE MEMBERSHIPS INCLUDE REPRESENTATIVES FROM ARC. ASSISTANT SINGLE FOR FINANCES AND RESOURCE. CDC, CMS, CAPTAIN OF DEFENSE, OASH. ODP. NIH. THESE ARE THE BREAD AND BUTTER PUBLIC HEALTH AGENCIES THAT WORK THROUGHOUT THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, AS WELL AS DEPARTMENT OF DEFENSE AND THE V.A. SO THE STEERING COMMITTEE SETS THE AGENDAS FOR THE PRINCIPLES' MEETINGS AND OVEREXPOSE MONITORING THE EFFORTS OF THE WORK GROUPS, WHICH IS WHERE THE WORK ACTUALLY GETS DONE. SO THE LIMP E.ATION WORK GROUPS ARE COCHAIRED BY A PRINCIPLE. THAT IS, SO THAT WE MAKE SURE THESE ARE NOT JUST SORT OF -- HOW CAN I SAY, PASSIVE ACTIVITIES, BUT REALLY, ACTIVE PRINCIPLES ARE ULTIMATELY WHERE THE BUCK STOPS AND SO THEY ARE ULTIMATELY WHERE THE BUCK STARTS STARTS, TOO. THE WORKING GROUPS, INVOLVE POPULATION RESEARCH, PUBLIC EDUCATION AND TRAINING DISPARITIES, SERVICES AND THEY ARE REFLECTIVE OF WHAT IS IN THE REPORT IN THE NATIONAL PAIN STRATEGY ITSELF. THAT'S THE WAY WE WANTED TO SET THIS UP. THERE'S AN ADDITIONAL WORK GROUP THAT'S NOT INCLUDED IN THE REPORT, THOUGH AND THAT IS TO PROVIDE AN EVALUATION MONITORING OF DELIVERABLES THOUGH THE ASSISTANT SECRETARY EVALUATION. WE HAVE A SYSTEM, IT'S KIND OF LIKE A SHAREPOINT WHERE, YOU KNOW, THE WORK GOES ON AND SO IT CAN BE SHARE SHARED AND VISIBLE AND MONITORS AND VAULTED AS WE GO FORWARD. SO ALICIA IS IS THAT THE UP AND WE HAVE ALL OF OUR WORK GROUP MEMBERS GANG ACCESS TO THAT. IT'S A LITTLE BIT CUMBERSOME, I FOUND, BUT I THINK WE'RE GOING TO MAKE IT WORK. AT ANY RATE, THE WORKING GROUPS ARE MEETING MONTHLY OR EVERY TWO MONTHS, IN CASE THAT'S AUTOS NOT POSSIBLE. AGAIN, WE INTEND TO CONTINUE THIS O. THE INSTRUCTIONS WE'VE BEEN GIVEN RIGHT NOW IN THIS TODAY OF TRANSITION, IS, YOU KNOW, THIS ADMINISTRATION IS HERE UNTIL JANUARY 20 AND WE'RE GOING TO CONTINUE TO WORK UP RIGHT UP UNTIL THE END. AND NOT THINK ABOUT ANYTHING ELSE THAT HAPPENS AFTER THAT. WHEN THE TRANSITION OCCURS, WE'RE ANYTHING TO BE BRIEFING THEM THIS. KIND OF ACTIVITY IS PUT INTO THE BRIEFING BOOK SO WE CAN INFORM THE TRANSITION TEAMS WILL GRADUALLY TAKE OVER WHAT, IS IMPORTANT AND WHAT GOES FORWARD. SO AGAIN WHAT WE'RE TRYING TO DO IS MAKE SURE THIS IS L SORT OF PLANTED AS AN IMPLEMENTATION ACTIVITY. SO THE PROGRESS SO FAR HAS BEEN SLOWLY I HAVE TO SAY, SOME OF THIS IS A RESULT OF NOT HAVING A LOT RESEARCH. WE'VE BEEN STAFFING UP IN MY OFFICE, GRADUALLY, AGAIN, APPRECIATING ALICIA'S JUMPING INTO THE ADMINISTRATIVE SIDE OF THIS ESPECIALLY. BUT WE HAVE DEVELOPED AN INVENTORY OF ON GOING AND PLANNED EFFORTS, THAT ADDRESS DELIVERABLES OF THE NATIONAL PAIN STRATEGY. AND EFFORT THAT IS CAN BE LEVERAGED TO IMPLEMENT THE OBJECTIVES. WE'RE SORTING THESE OUT BY RELEVANCE AND LINDA'S OFFICE WILL POST THEM ON THE IPRCC WEBSITE WHEN WE COMPLETED THIS PROCESS. THE WEBSITE WILL SERVICE ONE MEANS TO UPDATE MPS WE'RE WE'RE NOT GOING TO SET UP A SEPARATE WEBSITE. A MEANS PROVIDE -- WE WE DO WANT TO CONTINUE TO GET ADVICE FROM STAKEHOLDERS. S IN NOT A FACCA PROCESS. IT'S NOT A MATTER OF OFFICIAL SORT OF MEMBERSHIP NOT ON THE WORKING GROUPS BUT THEY ARE ABLE TO PROVIDE INPUTS NOT WORKING GROUPS THAT ARE REQUESTED AND WE INTEND TO DO THAT. THE STEERING COMMIT SENOW SLEEKING STAFF LEADS WITH EXPERTISE TO LEAD THESE ACTIVITIES, THE WORK GROUPS, AND ALL THE MEMBERS TO POPULATE THEM. SO THEY'RE POPULATED BY FEDERAL MEMBERS. IT'S ALSO COLLECTING A LIST OF EXTERNAL STAKEHOLDERS. TO GUIDE SUPPORT AND ADVICE AS APPROPRIATE TO IMPLEMENTATION. SO I'VE HAD LOTS OF MEETING WITH STAKEHOLDERS SO F. I BENEFIT GREATLY FROM THAT. I'VE LEARNED A LOT FROM THEM. YOU MEET IS WITH SOME ELECTED REPRESENTATIVES WHO ARE CONCERN WITH THE STRATEGY AS WELL. SO WE HAVE MET AND WE'RE PLEASED TO SEAT ENTHUSIASM. WE'VE BEEN ATTENDING MEETINGS OF PROFESSIONAL ORGANIZATIONS. CHRISTINE INCISE DISBEFORE SHE SPOKE AT THE -- IT WAS AN AUSTIN MEETING OF THE AMERICAN PAIN ASSOCIATION. SO THAT WAS KIND OF OUR INITIAL FORE TO SAY, YEAH, WE HAVE GOT THIS GOING. BUT I THINK WE'LL HAVE SOME OTHER OPPORTUNITIES. I'M PREPARE SOMETHING PUBLICATIONS RIGHT NOW, BLOCKS AND A JOURNAL ARTICLE THAT WE'LL PUT OUT TO, NOT SO MUCH DESCRIBE PROGRESS, BUT JUST TO KIND OF, YOU KNOW, STATE THE CASE THAT THIS PAIN STRATEGY IS REALLY AN IMPORTANT PRIORITY AND THAT WE'RE GOING TO CARRY IT FORWARD. SO THE TIMELINES, WE HAVE ESTABLISHED THE COUNCIL IN JUNE, WE HAVE CONVENED THE STEERING COMMITTEE AND IDENTIFIED MEMBERS IN SEPTEMBER, LAST MONTH. WE ESTABLISHED THE WORKING GROUP MEETINGS, WORK GROUP MEMBERS IN THIS PROCESS, AND THIS WILL BE COMPLETED BY NOVEMBER, SO THE WORKING GROUPS ARE, YOU KNOW, VARIABLELY NOW, START THEIR WORK OR AT LEAST GETTING NAMED. WE'LL CONVENE TEMVERY SHORTLY AS WELL. THE WILL MEET IN DECEMBER. AGAIN, BEFORE THE END OF THE ADMINISTRATION, SO WE HAVE A CHANCE TO SAY HEY, WE HAVE COME THIS FAR. SO THE COUNCIL WILL MEET AND THAT'S PRINCIPLE, AS I MENTIONED AND WE'LL HAVE AN IMPLEMENTATION AND COMPLETION OF SHORT TERM DELIVERABLES, WE HOPE BY JANUARY OF 18 SO THIS IS SHORT TERM MEETING ABOUT A YEAR. BUT WE'RE GOING TO BE GOING THROUGH THIS TRANSITION. THINGS MAY SLOW DOWN, MAY BE COMPLICATED, BUT AS I SAID, WE HAVE GOT PROFESSIONAL STAFF THAT IS GOING TO CARRY THIS FORWARD AND HAVE A CLEAR PICTURE OF HOW TO DO THAT NEW FOLKS IN THE DEPARTMENT GET SET SETTLED AND NEW PRINCIPLES GET ORIENTED TO THIS ACTIVITY AND WE'LL COMPLETE MEETING TERM DELIVERABLES IN 2018, 2020, I THINK IS SORT OF AN ESTIMATE. LONG-TERM, WE'LL DEVELOP A PLAN FOR LONG-TERM DELIVERANCE NEXT YEAR, AGAINST AFTER THINGS SETTLE, THE DUST SETTLES A BIT AND THOSE LONG-TERM DELIVERABLES WILL BE TARGET FORWARD 2021. AGAIN, THE STEERING COMMITTEE WILL HOLD BILATERAL OUTREACH MEETINGS IN COLLABORATION AND ENSURE DISSEMINATION INFORMATION AS WE PROGRESS. SO WE CAN COUNT ON NOSE SHORTLY AFTER, YOU MIGHT ASK ALICIA IF SHE HAD A THOUGHT IN MIND ABOUT WHEN WE MIGHT HAVE THE FIRST STAKEHOLDER MEETING. I THINK IT'S THE KIND OF THING, THINK ABOUT T. BUT IN CONCLUSION, I JUST WANT TO SAY, WE'RE TAKING VERY SERIOUSLY, THE NEED TO IMPLEMENT THE NATIONAL PAIN STRATEGIC PLAN STRATEGY, AS FULL EASY WE K. TOOK THREE YEARS TO CLEAR AND RELEASE, AND FOLLOW THE RELEASE OF THE CDC OPIOID-BASED I DIDN'T PRESCRIBING GUIDELINES AND HENCE, IT WILL PLAY ACRITICAL ROLE TO ENSURE THAT THOSE NEEDING CHRONIC PAIN CARE WILL RECEIVE THE HELP THEY NEED. WE HAVE A RESPONSIBILITY ACROSS GOVERNMENT AND STAKEHOLDER COMMUNITY TO, INSURE WE CARE APPROPRIATELY FOR ALL IMPORTANCE, SUFFERING FROM CHRONIC PAIN AS A COMPONENT OF THE ETHICAL CARE. THAT IS IN THE MISSION AND GOALS AND VALUES OF THE OFFICE OF ASSISTANT SECRETARY OF HEALTH. SO I WANT TO THANK YOU FOR YOUR ATTENTION. I'LL BE HAPPY TO ANSWER ANY QUESTIONS I CAN. AND LOOK FORWARD TO STICKING AROUND FOR THE MEETING. I WANT TO HEAR WHAT'S GOING ON. AND HOPEFULLY, COME BACK AND MEET UP WITH EVERYBODY AT A LATER INDICATE. >> THANK YOU MUCH, TOM. APPRECIATE YOU HEAR AT THE MEETING TODAY. QUESTION FROM CINDY TO START. >> THANK YOU VERY MUCH, YOU KNOW, YOU'VE BEEN REALLY GENEROUS ABOUT MEETING WITH GROUPS AND STAKE HOLDS ARE AND FOR GETTING UP TO SPEED ON THIS. I THINK THE NATIONAL PAIN STRATEGY HAS BEEN SO WELL-RECEIVED BY ALMOST THE ENTIRE PAIN COMMUNITY. LARGELY, BECAUSE OF THE OUTREACH AND THE FACT THAT ON THE WORKING GROUPS, THERE WERE AT LEAST, I THINK 80 PEOPLE. MANY OF THEM CAME FROM ALL ASPECTS OF THE PAIN COMMUNITY. SO WHEN YOU'RE DESCRIBING THE SET UP YOU'VE CREATED, UNDERSTAND IS THE COUNCIL PRINCIPLE. THE STEERING COMMITTEE, AND THE STRATEGIC PLANS. I'M WONDERINGS, IT SOUNDS LIKE THEY ARE ALL FEDERAL MEMBERS. I'M WONDER WHAT THE THOUGHT WAS AND WHETHER OR NOT YOU COULD ON THE WORKING GROUPS, INCLUDE MEMBERS OF THE PAIN COMMUNITY, TOO GET LARGER BUY-IN, AND B, BECAUSE PUBLIC-PRIVATE PARTNERSHIPS SOUNDS LIKE THEY WILL BE EXTREMELY IMPORTANT IN MOVING FORWARD, GIVEN THAT WE DON'T KNOW WHAT THE RESOURCES ARE. >> CRITICALLY IMPORTANT -- IN TERMS OF IMPLEMENTATION PROCESSES, I MEAN, WE HAVE TO IMPLEMENT THIS WITHIN GOVERNMENT. THAT DOES NOT MEAN WE ARE WORKING WITH THE EXTERNAL STAKEHOLDERS TO GAIN ALL THAT HAVE ENERGY AND WE EXPECT THAT TO HAPPEN. BUT BECAUSE -- IT'S NOT JUST A GOVERNMENT DOCUMENT. THAT'S FOR SURE. IT IS A DOCUMENT THAT INVOLVES, YOU KNOW, NONGOVERNMENT AS WELL. BUT WE HAVE GOAT GOVERNMENT SIDE TELEVISION, FIRST OF ALL, AND TO BE IN PLACE, AS I MENTIONED WE'RE GOING THROUGH A PERIOD OF UNCERTAINTY. WE'RE GOING TO MAKE IN WORK FROM THE PROFESSIONAL SIDE. WHAT WE HAVE HAD TO DO EXPLORE IS WHAT ARE THE IMPLICATIONS OF EITHER MEMBERSHIP OR ADVISORY SORT OF FUNCTIONS AND IF WE WERE TO HAVE MEMBERS, ACTUAL MEMBERS, WE'D HAVE TO GO THROUGH A DIFFERENT SORT OF BUREAUCRATIC PROCESS. IT'S ALMOST LIKE THE FEDERAL ADVISORY COMMITTEE PROCESS R MEMBERS HAVE HAVE TO BE VETTED, NO CONFLICTS OF INTEREST AND I'VE BEEN ON THE ADVISORY COMMITTEES. AND MAYBE I CAN GET A LITTLE BIT OF COMMENT FROM FOLKS AT NINDS BECAUSE YOU DID DO THIS THE IPRCC IS A COMMIT THAT HE REPORTS TO HHS ABOUT PAIN, NATIONAL PAIN STRATEGIES SO I WOULD THINK THAT IPRCC CAN REACH OUT TO THE STAKEHOLDERS AND SERVE IN THAT FUNCTION AS WELL. >> AND I WAS TALKING ABOUT WORK GROUPS. I JUST WANTED TO Z THAT WE'RE DEFINITELY SENSITIVE TESTIFY FANG THAT EXTERNAL PARTNERS, THAT HAVE A VESTED INTEREST IN THIS WORK, AND WE KNOW WE CANNOT DO THIS HEAVY LIFT ALONE. SO AS PART OF THE WORKING GROUPS, WE WILL NOT HAVE A FORMAL MEMBERSHIP, BUT EACH OF THE FEDERAL WORK GROUPS WILL REACH OUT TO STAKEHOLDERS AND ASK FOR INPUT ALONG THE WAY. SO IT'S NOT AS IF WE WERE OPERATING IN A VACUUM. THERE WILL BE OPPORTUNITIES FOR BUY-IN AS WELL AS CHECK-IN TO MAKE SURE THAT WE'RE MOVING ON THE RIGHT TRACK. IN ADDITION TO THAT, AS DR. NOVOTNY SAID, DOLLAR GOING TO BE TWO STAKEHOLDER MEETINGS AS WELL. IN WHICH WE'LL BE PRESENTING THE INFORMATION TO A LARGER GROUP OF STAKEHOLDERS AND IN THOSE INSTANCES, THERE WILL ALSO BE OPPORTUNITIES FOR DISCUSSION, BUY-IN, ARE WE GOING TO -- ARE WE ON THE RIGHT TRACK AND WAYS IN WHICH WE CAN WORK TOGETHER. SO I WANTED POINT OUT THOSE TWO THINGS SOTHANK YOU FOR RAISING THAT. IF IT DOESN'T SEEM LIKE IT'S SUFFICIENT, YOU KNOW WHO TO CALL. WILL THIS BE PUBLISHED SO WE ARE A WAY. IS THERE BEHIND OF PUBLIC NOTIFICATION SO WE KNOW ABOUT IT. >> YEAH, WE TALKED ABOUT THIS A LITTLE BIT, PENNY AND IT'S NOT QUITE, WE HAVE VISIONS FOR HOW WE DO THE BIANNUAL STAKEHOLDER MEETINGS. THE OTHER PIECE THAT ALICIA MENTIONED WOULD BE ARE ON A CONTINUUM BASIS. IF THERE'S AN EXPERT THAT NEEDS TO WEIGH IN ON ONE PARTICULAR GROUP, THEY WOULD BE CALLED IN. BUT FOR A LARGER MEETING, WE HAVE THROUGH OUR OFFICE, I THINK A PRETTY GOOD DISTRIBUTION LIST AT THIS POINT OF REACHING OUT TO PEOPLE. SO WE HAVE GOT THE WEBSITE, I THINK SEVERAL THOUSAND PEOPLE NOW ON OUR LIST SERVE, THAT HAVE SIGNED IN WE HAVEN'T GOTTEN QUITE DOWN TO THE DETAILS OF HOW WE'RE LOOKING AT ALL THE PEOPLE TOGETHER. BUT LETTING THEM KNOW WHEN, WHERE AND HOW TO GET IN TOUCH. I THINK WE'RE PRETTY WELL SET UP FOR THAT ALREADY. >> HI, LIND ADJUST A QUICK QUESTION. I THINK THAT'S ONE OF THE THINGS WE HAVE TO BE CAREFUL. IS WITH COP P CONFLICT OF INTEREST, THAT IT WAS MENTIONED. WHAT I THINK IT'S MORE DIFFICULT TO DO THOUGH IS TO BALANCE THE BIAS THAT PEOPLE MAY HAVE. THING ALMOST EVERYBODY NOW HAS BIAS. EITHER IN FAVOR OF OPIATEORS AGAINST. HOW CAN WE MAKE SURE WE HAVE A FAIR REPRESENTATION OF THE DIFFERENT THINKING GROUPS THERE. >> WHEN THE WORK GROUPS ARE SET UP, WE HAVE A PRETTY CLEAR MESSAGE FROM THE NATIONAL PAIN. >> Announcer: PLEASE PARDON INTERRUPTION. YOUR CONFERENCE CONTAINS LESS THAN THREE PARTICIPANTS AT THIS TIME. >> [LAUGHTER] SORRY ABOUT THAT. WE HAVE A LIST OF KEY PEOPLE WHO SHOULD BE ON THESE MEETINGS, AND I THINK IT WILL BE VERY MUCH ALIGNED WITH THE KINDS OF GROUPS THAT WERE INVOLVED IN THE NATIONAL PAIN STRATEGY DEVELOPMENT TO BEGIN WITH. YOU KNOW, CLEARLY, WE NEED, AS TOM MENTIONED, TOO AWARE OF THE RELATED ISSUES, AND THE INTERSECTIONS. THING COMMITTEE IN PARTICULAR, PEOPLE WHO PUT TOGETHER THE NATIONAL PAIN STRATEGY, REALLY, REALLY WANT TO KEEP IN MIND IT'S IMPORTANT. THIS IS A PAIN STRATEGY. AND THAT LABORATORY PRIMARY FOCUS. >> THANK YOU MUCH FOR THE PRESENTATION. I'M CURIOUS. YOU KNOW, GIVE THE FACT THAT WE HAVE TWO FOUNDAMENTAL EPIDEMICS OCCURRING, THE CHRONIC PAIN EPIDEMIC AND THE OPIOID EPIDEMIC. AND THE ALMOST COINCIDENTAL RELEASE OF GUIDELINES AND NP SERGEANT I'M WONDER ATHTHE LEVEL OF HHS WHETHER THESE INITIATIVES ARE GOING TO COME TOGETHER AT SOME LEVEL, WHERE THERE'S SYNERGY CONTINUE WHAT WILL BE OCCUR WITHING MPS AND HHS AND THE OPIOID EPIDEMIC. ESPECIALLY SINCE I THINK THE MAGNITUDE IS DIFFERENT SLATED OR FOR CHRONIC PAIN. I'M JUST CURIOUS AS TO WHETHER THERE'S AN OPPORTUNITY TO BRING SOME OF THESE THINGS TOGETHER. >> IT'S NOT JUST AN OPPORTUNITY OF THE I THINK IT'S A RESPONSIBILITY. AND THAT'S WHAT PIQUE TRYING TO COMP THE SURGEON GENERAL HAS GONE ON AN OPIOID TOUR. I THINK 13 DIFFERENT VENUES, WHERE HE'S TALKING MOSTLY ABOUT REFORMING -- PRESCRIBING PRACTICES. BUT WHAT WE DID AND OVER TIME HE WENT OUT, I ASKED DIRKS BY DOS THIS? MENTION THE PAIN STRATEGY. LET PEOPLE KNOW, THIS IS THE OTHER SIDE OF THE COIN, SO THAT IT ISN'T SOMETHING THAT PENDULUMS BACK. AND SOMETHING THAT HAS BEEN TAKEN NOTE BY THE JAIL ACTUALLY, AND ABOUT THAT VERY ISSUE. THEY RECOGNIZE THE POTENTIAL FOR THIS TO HAPPEN AND THE PAIN STRATEGY IS THERE TO MAKE SURE THAT THERE IS A COEXISTING CONCERN FOR THE ISSUES OF PAIN MANAGEMENT. WE NEED TO KEEP MAKING COMMUNICATION HAPPEN, THAT WOULD BE AGAIN, AT SOME SCIENTIFIC MEETINGS, MEDICAL MEETINGS. PLACES LIKE OPHA. SOME BLOGGING AND TO MAKE SURE THAT WE LET THE SORT OF PUBLIC KNOW, THROUGH AS MANY VENUES AS WE K. FOR INSTANCE, WE HAVE 10 REGIONAL OFFICES OF THE PUBLIC HEALTH SERVICE SO I'VE BEEN ON THE CALL, A COUPLE OF TIMES. SO IT IS THAT'S WHAT THE OFFICE OF ASSISTANT SECRETARY DOES. TO MAKE SURE THESE THINGS GET TRANSFERRED, TRANSLATED, TRANSDUCED, HOOKED UP, IN OTHER PLACES. SO I THINK IT'S OUR RESPONSIBILITY TO DO THAT. IT'S NOT AN OPPORTUNITY. ALONE. THERE ARE A COUPLE OF INSTANCES ALREADY, WHERE SOME OF THE GOVERNMENT INITIATIVES OPIOIDS, HAS ACTUALLY INTELLECTED WITH PULLING RESOURCES OR PUSHING INITIATIVES ON CHRONIC PAIN. SO RICK IS GOING TO TALK ABOUT SYSTEMATIC REVIEW THAT'S BEING DONE TO LOOKING AT NON-PHARMAO LOGICAL PAPER MANAGEMENT ACROSS THE COUNTRY, AND THE UTILIZATION. WHEN THE RESEARCH AGENDA CAME OUT ON OPIOID-BASED I DIDN'T THIS IS SUMMER, IT WAS VERY INCLUSIVE OF SOME PAIN MANAGEMENT PIECES. I THINK THOSE KIND OF THINGS, SUGGEST THAT THE MESSAGES THAT, THOMAS SAID, THAT PEOPLE FROM INSIDE AND OUTSIDE OF COURSE TRYING TO GET AROUND, BUT IT IS HAPPENING. >> YOU'RE RIGHT. THE RESOURCES. AND WE HAVE HAD THIS EPIDEMIC OF GREAT CONCERN. AND C CDC IS A VERY EFFECTIVELY COMMUNICATING ORGANIZATION IS VERY GOOD. I USED TO WORK THERE. I KNOW. I'M GOING TO BE HIRING ONE SENIOR LEVEL STAFF PERSON. >> AND JUST ONE FOLLOW-UP COMMENT, YES, I THINK SUBSTANTIAL RESOURCES AND RIGHTLY DEVOTED TOWARDS HELPING THE AFFLICTED AND TOWARDS PREVENTION, BUT WHERE I THINK THERE'S A DIMINISHED RESOURCE IS SOLUTION. IS MITIGATING THE NEED FOR OPIOIDS THROUGH DISCOVERY. AND IF ONE CAN MITIGATE THE NEED FOR OPIOIDS, ELIMINATING AS MUCH AS POSSIBLE, OPIOIDS FROM CLINICAL PRACTICE, WITH NEW DELIVER, NEW METHODS, THEN BOTH EPIDEMICS ARE LARGELY RESOLVED. >> THAT WILL BE THE SINGLE OVERRIDING COMMUNICATION OF THIS OBJECTIVE. >> [SPEAKING AWAY FROM MICROPHONE] >> I'M SORRY. WHAT'S THE BEST WAY OF FOLLOWING WHAT'S MAPPING ON THE OPIOID SIDE WHATEVER HHS IS DOING. I KNOW THERE'S A LOT OF CDC. I DON'T KNOW IF THERE'S LEADERSHIP ELSEWHERE. A LARGE PART OF THE PULPIT HAS BEEN TAKEN UP BY THE SURGEON GENERAL. THAT'S BEEN A STRONG FOCUS OF HIS WORK AND RIGHTFULLY SO. HOW ARE WE GOING TO FOLLOW THAT? , I GUESS, YOU KNOW, WE DO FAIRLY CAREFUL REPORTING ON ACTIVITIES, QUARTERLY REPORT IS GIVEN TO THE SECTOR FOR FINANCE AND RESOURCE ON VARIOUS PRIORITY ISSUES. FOR INSTANCE, THE OPIOID INITIATIVE. AND I GO TO THOSE, NOW. SO I THINK WE HAVE THE OPPORTUNITY TO CONTINUE TO PLUG PLUG THAT IN AND BE AWARE OF WHAT THE INTERACTIONS ARE. IT'S AMAZING WE SPEND ALL DAY LONG GOING TO MEETINGS. AND THE REST OF THE TIME IS, WE'RE DOING DOCUMENT THAT IS COME THROUGH THREW THAT HAVE REPORTS ON VARIOUS THINGS SO THOSE ARE THE OPPORTUNITIES WE HAVE TO, YOU KNOW, CONNECT UP ON WHAT WE DO WITH THE OPIOID EPIDEMIC. AND THERE CERTAINLY IS COMMUNICATION ON THIS. KEEP IT VISIBLE ON THE PAIN SIDE BECAUSE THE OPIOID SIDE IS PRETTIED MUCH IN EVERYBODY'S MIND AND I THINK THE PAIN SIDE HAS TO BE BALANCED OUT. IT'S WHAT WE'RE TRYING TO DO AND LOOK FOR THE HELP THAT ALL OF YOU CAN PROVIDE, AS A VISIBILITY ISSUE AS WELL. JUST THE GRANULAR QUESTION ABOUT THE STATUS OF THE COMPILATIONS WHATEVER IS AVAILABLE RIGHT NOW. THERE'S AN ENORMOUS ACTIVITY GOING ON AT STATE LEVEL. MANY OF THESE EFFORTS, BEGIN BY SAYING, WE OUGHT TO GET TOGETHER, EVERYTHING IN ONE PLACE AND I'M JUST CURIOUS AS TO IS THERE NOW A LINK THAT PROVIDES SOME OF THIS MATERIAL OR WHAT'S THE TIMELINE FOR ASSEMBLING THAT. SO THAT THE STATE EFFORTS DON'T RE-INVENT THE WHEEL. >> LIND A COULD YOU SPEAK TO THAT BY ANY CHANCE? >> Linda Porter: I DON'T HAVE MUCH INPUT AS TO WHERE WE WOULD BE ABLE TO LOOK. AND BOY, THERE'S A LOT GOING ON AS DAN MENTIONED. S I MEANT FEDERAL EFFORT THAT IS CAN INFORM STATE EFFORTS LIKE WHAT ARE MODEL CURRICULA. WHAT ARE OPIOID MANAGEMENT RECOMMENDATION FROM DIFFERENT PROFESSIONAL SOCIETIES. >> Linda Porter: I MEAN, I WOULD GUESS THE AVENUE IS NOW WHAT WE HAVE FOR COMMUNICATION. >> I THINK HE'S ASKING BETTER INVENTORY. I MENTIONED WE'RE GOING TO BE POSTING ON THE I'M SORRY WEBSITE AND WE HAVEN'T YET DONE THAT I KNOW. PART OF THE STATE SYSTEM THE PERSON ONE. THIS IS WHERE OUR REGIONAL DIRECTORS -- THIS GIVE HE IS AN IDEA TO GET THEM INTO ACTION. SO THEY'RE DON'T THIS AND NOT JUST SORT OF PERIPHERAL OFFICES. SO THAT'S THE KIND OF THING WE MIGHT BE ABLE TO ASK THEM TO DO A DATA CALL. ALONG THE LINES OF THE STATES TO SEE WHERE WE CAN GET MORE INFORMATION FROM THE STATESIDE. >> I WILL JUST EMPHASIZE, THINGS A TIME-SENSITIVE OPPORTUNITY, AND THERE'S NO STATE, WHICH WOULD NOT DRAW UPON, SUCH AN INVENTORY RIGHT NOW. THE CONFERS I HEAR IS ONE COMMONLY THAT, WE'RE GOING TO DEEP WILLIAM OPIOID DRUG PROBLEM, BY FINDING NEW AND BETTER DRUGS. I STILL DON'T HEAR A LOT ABOUT INTEGRATIVE MEDICINE. I JUST FINISH AID MEETING WEEK W AMERICAN MESSAGE THERAPY ASSOCIATION. THE D.O.D. IS VERY INVOLVED WITHAC PUNKURE, MESSAGE, BIOFEEDBACK. BUT WE'RE THOUGHTED, I THINK, BECAUSE OF THE DIFFICULTY ON A NATIONAL LEVEL FOR PAIN FOR THESE TYPES OF NON-PHARMACOLOGIC MO CALLITIES AND AND I'M HOPING, BECAUSE I'VE HEARD IT BEFORE FROM THIS BODY, THAT'S GOING TO REMAIN A FOCUS AS WE GO FORWARD THAT, WE INVEST JUST AS MUCH IN THESE PROVEN MODALITIES, AS WE DO TRYING TO FIND THE NEXT SILVERBULLET FOR PAIN MANAGEMENT MANAGEMENT. THANK YOU. >> Catherine Underwood: WHEN WE WERE IN THE WORK GROUPS, DEVELOPING THE NATIONAL PAIN STRATEGIC PLAN YEAR, WE WERE ASKED TO LIST THE VARIOUS AGENCIES AND PROFESSIONAL ORGANIZATIONS, ET CETERA, ET CETERA, AS KEY STAKEHOLDERS IS IT A RIGHT ASSUMPTION TO BELIEVE, THOSE ARE THE EXACT TYPES OF MAKEUP OF THE WORK GROUPS OR NOT? >> THAT LIST OF KEY STAKEHOLDERS TO BE INVOED WILL BE SENT TO THE WORK GROUPS AND WHERE WE HAVE SPECIFIC NAMES, PEOPLE OR ORGANIZATION VS. VOLUNTEERED, EITHER, YOU KNOW, THROUGH CONVERSATIONS, WITH TOM AND ALICIA AND MYSELF OR AT MEETINGS OR THROUGH OUR PUBLIC COMMENT PERIOD, WE HAVE GOT ALL THAT KIND OF IN THE WORKS. >> ANYMORE QUESTIONS FOR TOM. >> THANK YOU UPON. AND THANK YOU MUCH, TOM, FOR MAKING THE TREK OVER HERE. WE HAVE SCHEDULED NOW, A BREAK UNTIL 10:30. AND THEN WE'LL MOVE BACK INTO SOME UPDATES ON THINGS THAT OF COURSE HAPPENING, RELATIVE TO THE NATIONAL PAIN STRATEGY OBJECTIVES AND CHRIS, I THINK YOU'RE THE ONLY ONE ON THE PHONE. WILL YOU BE ABLE TO JOIN BACK IN AT 10:30? >> CHRIS: YUP. >> THANKS VERY MUCH. THERE'S COFFEE DOWNSTAIRS AND WE HAVE THAT MACHINE OVER THERE, I THINK ALLEN KNOWS HOW TO WORK IT. [LAUGHTER] SO WHAT WE HAVE PLANNED FOR THE NEXT PART OF THE MORNING, IS RUN THROUGH SOME OF THE STEP THAT IS OF COURSE TAKEN TO ADDRESS THE NATIONAL PAIN STRATEGY OR SOME THAT HAVE BUBBLED UP FROM OTHER EFFORTS ACROSS THE GOVERNMENT THAT ACTUALLY DO ADDRESS THE NATIONAL PAIN STRATEGY OBJECTIVE AND WE'LL ALSO HAVE SOME UPDATES ON SOME OF THE PROGRESS STEP THAT IS WE PRESENTED TO YOU IN THE PAST, BUT JUST KIND OF WHERE THEY ARE NOW F THEY HAVE MOVED FORWARD A LITTLE BIT. SO A FEW OF THESE THINGS WILL BE FAMILIAR TO PEOPLE IN THE GROUP AND SOME OF THEM I THINK ARE BRAND-NEW. SO IT'S REALLY, AN INFORMATIONAL SESSION. WE'LL LEAVE TIME AT THE END OF EACH OF THE SESSIONS SO IF YOU DO HAVE QUESTIONS, WE CAN RUN THROUGH THEM. AND WHAT I'LL START OFF WITH IS SOMETHING YOU HEARD ABOUT IS IN THE WORKS BUT IS NOW, A COMPLETE EFFORT IF YOU WILL. SO WHEN THE POPULATION RESEARCH GROUPS DEVELOPING THE NATIONAL PAIN STRATEGY, THEY ACTUALLY SAT DOWN AND VERY CAREFULLY PUT TOGETHER A SCREENING TOOL TO REALLY ADDRESS HOW PAIN INTERFERES WITH PEOPLE'S LIVES, AND USE THAT TO SORT OF HELP UNDERLINE THE DEFINITION OF HIGH-IMPACT CHRONIC PAIN THAT CAME UP THROUGHOUT NATIONAL PAIN STRATEGY. AND SO THAT GROUP DEVELOPED, AN ASSESSMENT TOOL, MEANT FOR SURVEY LEVEL RESEARCH AND RECOGNIZED, THAT THERE WAS A NEED TO ACTUALLY VALIDATE THE QUESTION AND IT IS TOOL, TO MAKE SURE THAT THEY WERE PUT TOGETHER PROPERLY AND WOULD BE MEANINGFUL IN LARGE SCALE STUDIES AND SO MICHAEL LON LONCORFF APPLIED FOR FUNDING THROUGH THE NIH. WITH AN ACTUAL SMALL AMOUNT OF MONEY, TOO RUN A SURVEY, AND TO WORK WITH SOME HEALTHCARE DATA IN THE LARGE HEALTHCARE SYSTEM TO TEST SOME OF THE QUESTION AND IT IS SCREENING TOOL THAT THEY HAD DEVELOPED AND THEY PUT TOGETHER A PAPER. THEY PUBLISHED THE FINDINGS ON THIS. AND THAT PAPER WAS RELEASED VERY RECENTLY. I'VE GOOD GOTTESMAN AT THE BOTTOM OF THE SLIDE HERE, THE REFERENCE, BUT IF I THINK YOU WENT TO PUB MED AND LOOK UP SON KOUR. IF ANYONE WANT ACE PUBLICATION, THEY CAN SEND HE'S QUERY AND I'LL FORWARD IT BY E-MAIL. THAT PAPER ADDRESSED THE FIRST OBJECTIVE OF THE NATIONAL PAIN RESEARCH, THE DELIVERABLE ON THE DOCUMENT WAS ADDRESS ADDRESSED BY TESTING BRIEF ASSESSMENT TOOL. SKY HERE, THE NUMBERS THEY DID THE PILOT ON FROM THE HEALTH PLAN, FOR THE -- IT WAS ACTUALLY A MAIL-IN SURVEY, QUITE LARGE. 7 70 PEOPLE AND THEN THE EXAMINATION OF THE ELECTRONIC HEALTH RECORDS TO LOOKING AT USE OF CARE SERVICES BY PEOPLE WITH HIGH IMPACT CHRONIC PAIN. AND A HUGE NUMBER OF HEALTHCARE RECORDS. A COUPLE OF THE FINDINGS THEY HAD FROM THIS TEST, PRIMARY, IT WAS TO VALIDATE THE TOOL BUT THEY FOUND THAT THE RESPONDENTS, 14% OF THE ENROLLEES IN THE HEALTHCARE PLAN, THAT THEY SURVEYED, HAD HIGH IMPACT CHRONIC PAIN, ACCORD ACCORDING TO THE DEFINITION OF THE NATIONAL PAIN STRATEGIC PLAN YEAR, THEY HAD HIGH USE OF HEALTHCARE SERVICES AND FROM THE ELECTRONIC HEALTHCARE DATA, COST OF HEALTHCARE SERVICES WAS HIGHER THAN THIS GROUP. MOST OF THEIR TREATMENT WAS RECEIVED THROUGH THE PRIMARY CARE COMPONENTS OF THE HEALTHCARE SYSTEM OF WHICH THEY WERE ENROLLED AND I THINK MORE IMPORTANTLY, AND I'M NOT SURE WHAT MOWER? I THINK IT WAS SUPPOSED SUPPOSED TO BE LOWER. THAT WAS MY TYPO. BUT THEY HAVE A LOWER QUALITY OF LIFE. SO THIS IS A REALLY NICE, I THINK, GOING TO BE A HELPFUL TOOL IN THE LONG RUN MEANT FOR LARGER POPULATION STUDIES TO REALLY DEFINE HIGH-IMPACT CHRONIC PAIN. AND THE HEALTHY PEOPLE 2020 AND THE NATIONAL HEALTH GROUP SURVEY EFFORTS WERE ALSO RETROSPECTIVELIED TO THE OBJECTIVES OF THE POPULATION RESEARCH GROUP FOR THE NATIONAL PAIN STRATEGY. CHAD HELL MACK WAS THE LEADER ON ALL THE EFFORTS THAT I'M GOING TO MENTION, RELATE TO THESE TWO EFFORTS. THE HEALTHY PEOPLE 2020 AND HEALTHY PEOPLE 2030, AS WELL AS THE HEALTH INTERVIEW SURVEY QUESTION AND HE CONTINUES TO WORK ON THESE, AS WE MOVE FORWARD TO GET OBJECTIVES, RELATED TO HIGH IMPACT CHRONIC PAIN, INTO HEALTHY PEOPLE 2030. IT'S A VERY SORT OF COMPLEX PROCESS WISE, TASK TO GET THESE THINGS ACCEPTED. SO HEALTHY PEOPLES IS SOMETHING THAT WAS DEVELOPED BY THE SECRETARY'S OFFICE. I THINK PROBABLY DECADES AGO, PROBABLY AT 90 AND IT HAS FOUR PRIMARY OBJECT ITCHES TO LOOKING AT WAYS AND SORT OF MONITOR WAYS THAT THE PUBLIC HEALTH AT LARGE CAN HAVE A HIGHER QUALITY AND LONGER LIFE, THEY LIVE FREE AND PREVENTIBLE DISEASE DISABILITY AND PREMATURE DEATH. HEALTH EQUITY WAS AN IMPORTANT PART OF IT, TOO IMPAIRED PROVE THE HEALTH OF GROUPS ALL ACROSS THE POPULATIONS AND THEN TO CREATE SOCIAL AND PHYSICAL ENVIRONMENTS TO PROMOTE GOOD HEALTH, AGAIN FOR ALL POPULATIONS AND PROMOTE QUALITY OF LIFE, HEALTHY DEVELOPMENT, AND HEALTHY BEHAVIORS ACROSS THE LIFE SPAN. SO TO GET AN OBJECTIVE INTO HEALTHY PEOPLE 2020, I THINK CHAD MET THE DEADLINE FOR ALL OF THE PIECES AND FORMS AND INFORMATION THAT HAD TO BE TOGETHER BY TODAY. IT WAS PRETTY TIGHT. BUT HE KEPT PUSHING THROUGH. -- THE ADULT LEVEL POPULATION IS WHAT WE HAD ENOUGH BASELINE DATA ON IS WHY THIS WAS TARGETD TO ADULTS. IT'S THE FIRST STEP. SO THERE ARE THREE REMAINING OBJECTIVES THAT THE GROUP FELT WERE REALLY IMPORTANT THAT HOPEFULLY, WILL MAKE IT INTO HEALTHY PEOPLE 2020 -- 2030. SORRY. AND I THINK, YOU KNOW, SO IN ORDER TO GET AN OBJECTIVE INTO HEALTHY PEOPLE, YOU NEED TO HAVE BASELINE DATA AND THE DATA IN THE NATIONAL HEALTH INTERVIEW SURVEYS, WASN'T REALLY TARGETED TO HIGH IMPACT CHRONIC PAIN AS DEFINED BY THE NATIONAL PAIN STRATEGY. EXPERTS GOT TOGETHER AND DEVELOPED A SET OF QUESTION THAT WOULD TRY AND GET AT THE HIGH IMPACT CHRONIC PAIN QUESTION. THESE COGNITIVELY TESTED THROUGH THE GROUP AT CDC THAT SPECIALIZE THAT IS N THAT EFFORT AND QUESTIONS WERE PAID FOR AND PUT INTO THE 2016-17 NATIONAL HEALTH INTERVIEW SURVEYS. HAVE YOU TO HAVE TWO YEARS OF BASELINE DATA THEY ARE CHANGING THE SET OF QUESTIONS? 2018. CHAD HAS LED THE GROUP W FOLKS, AND SOMEHOW GET THESE QUESTIONS INTO THE NATIONAL HEALTH INTERVIEW SURVEY OF HOW WE MIGHT EXPECT AND WHAT WE WERE HOPING FOR, RELATED TO HIGH IMPACT AND CHRONIC PAIN FOR 2018 ONWARDS. SO THAT'S INCLUDED IN THE NEXT STEPS FOR THIS PROJECT. SO THE DATA FOR 2016, OBVIOUSLY, OUT SOON, 2017, WE HAVE ANOTHER YEAR TO WAIT R WAIT BEFORE THAT'S OUT. BUT THE STEPS TO ADDRESS THE PAIN STRATEGY ARE TO ANALYZE WHAT WE GET BACK FROM THAT SURVEY DATA AND AND PERHAPS REVISE THE QUESTIONS F THEY HAVEN'T COME BACK WITH THE ADEQUATE INFORMATION THAT WE NEED. WE WILL HAVE TO LOOK FOR FUND FOR EXAMPLE ADDITIONAL QUESTIONS. THE FIRST TWO WERE FUNDED BY NINDS. THANKS TO WALTER'S GENEROSITY AND THEY ARE NOT INEXPENSIVE. THEN TO BEGIN PLANNING FOR HEALTHY PEOPLE 2030. AND CHAD'S ON THAT, AND I THINK ONE OF THE CONCERNS THAT HE HAS RELAYED TO US S THEY EXPECT TO CUT THEM DOWN BY ALMOST 50%. SO TRYING TO GET CHRONIC PAIN IN THERE IS GOING TO BE A BIGGER CHALLENGE THAN IT WAS. WE HOPE THAT KIND OF SUPPORT WILL HELP PUSH THESE THROUGH AND THEN REDESIGN OF THE QUESTIONS OF SOME OF THAT WORK HAS ALREADY BEEN INITIATED. SO IF PEOPLE HAVE QUESTIONS FOR MAD, WE WILL COME BACK TO THAT AT THE END. I'VE LEFT TIME FOR QUESTIONS. >> SO ONE OF THE OTHER EVERIES RELATED TO NATIONAL PAIN STRATEGY THAT YOU'VE HEARD OCCUPYDATES ON, OVER TIME IS THE CENTERS OF EXCELLENCE FOR PAIN EDUCATION. THIS EFFORT HAS BEEN LED BY DAVE THOMAS FROM NEED A. IT'S A PAIN CONSORTIUM EFFORT AND THE IDEA IS WE HAVE REACHED OUT THROUGH, TOO CONTRACTUAL SUPPORT, TOO CENTERS OF EXCELLENCE ACROSS THE COUNTRY, WHO HAVE RESEARCH EXPORTS ON PAIN AND EDUCATION EXPERTS AND WHAT THEY WILL DO, ROBBERY TO SET UP, EACH ONE, EACH OF THOSE CENTERS WILL BE SETTING UP OR HAVE SET UP FUNDS ALREADY, MODULES THAT ARE CASE-BASED MOST OF VERY COMPLEX AND COMPLICATED AND THE IDEA IS THAT THESE TOOLS AS PART OF THE CONTRACT S THE PEOPLE WHO, THE CENTER OF EXCELLENCE HAS TO EVALUATE THE TOOLS IN THEIR OWN CURRICULUM AND THEY ARE REQUIRED TO DISSEMINATE THOSE TOOLS ONCE THEY'VE BEEN EVALUATED TO OTHER SCHOOLS TO USE THEM AND THEN FOR OUR PART AT THE NIH, WE WILL POST THESE ONLINE, THROUGH THE PAIN CONSORTIUM WEBSITE, AS THEY BECOME AVAILABLE. SO AETNA IS ALREADY UP ONLINE AND HOPEFULLY, BEING PUT INTO USE. THIS ONE'S BEEN EVALUATED. THERE'S BEEN A PAPER PUBLISHED ON ITS EFFECTIVENESS IN A GROUP OF MEDICAL STUDENTS AND IT'S VERY, VERY INFORMATIVE AND SO IF YOU GET A CHANCE TO LOOKING AT IT. CAN YOU GO TO THE PAIN CONSORTIUM WEBSITE. FROM WHAT I UNDERSTAND, FROM DAVE IS THAT THE CASE-BASE SCENARIO ON YOU BURNING MOUSE SIN CHROME IS COMING OUT ALMOST MOMENTARILY. SO THIS WILL BE THE SECOND ONE THAT WILL BE POSTED AND READY FOR ALL OF I HAVEN'T SEEN IT YET. BUT I'M ACTUALLY REALLY ANXIOUS TO LOOK THROUGH T. AND SHORTLY AFTER THAT, WE EXPECT TO FOLLOW THIS PERSON'S NAME IS PETER JAMES AND HE'S A VETERAN. THESE ARE REAL PEOPLE, WHO HAVE PHANTOM LIMB PAIN AND THAT CASE IS ALSO QUITE CLOSE. MAYBE END OF THE YEAR EXPECTATION. SO THESE ARE ALL, TOO SOME EXTENT, CONSISTENT AND THEY ARE PUBLICLY AVAILABLE THROUGHOUT PAIN CONSORTIUM WEBSITE. THE IDEA WITH THE NATIONAL PAIN STRATEGY IS THAT THIS WILL SERVE AS ONE SET OF TEACHING RESOURCES THAT AT SOME POINT, WILL BE COLBEHIND, I MEAN, THERE'S AN ENORMOUS AMOUNT OF INFORMATION OUT THERE ALREADY THROUGH ORGANIZATIONS, THROUGH PROFESSIONAL SOCIETIES, AND THAT AT SOME POINT, WE WILL FIND OR HOPEFULLY, A CENTRAL REPOSITORY WHERE THESE CAN BE KEPT, MONITORED AND UPDATED. THIS IS SOMETHING YOU MAY NOT HAVE HEARD ABOUT YET, BUT I THOUGHT WAS REALLY EXCITING, ONCE I SAW HOW IT WAS PUBLISHED. SO EARLY THIS YEAR, THE SECRETARY ASKED ALL THE HHS AGENCIES TO PULL TOGETHER INFORMATION FROM THEIR RESEARCH PORTFOLIOS, THAT RELATED TO OPIOIDS AND ADDITION AND ALSO TO CHRONIC PAIN MANAGEMENT AND SO YOU'VE GOT, YOU KNOW, HERE'S THE BALANCE PIECE COMING IN THE AGENCIES PULLED TOGETHER A PORTFOLIO AND OFFICE SET UP RESEARCH PRIORITIES THAT CAME BACK TO THE AGENCIES AND SAID, WHICH ONCE ARE YOU CURRENTLY WORK O. WHICH ONCE CAN YOU GET STARTED O. HOW SOON, HOW MUCH MONEY, ET CETERA. ET CETERA. AND WHEN WE WENT THROUGH THE PRIORITY, THERE WERE MANY RELATED TO CHRONIC PAIN. AND SO THING HERE, WE'RE SEEING ONE OF THE PERFORMS, WHERE THE GOVERNMENT IS VERY SENSITIVE TO THE FACT THAT IF WE DON'T FIX THE CHRONIC PAIN PROBLEM THROUGH RESEARCH AND OTHER -- WE'RE STILL GOING TO BE DEALING WITH OPIOID PROBLEM. THIS IS POST BOD THE WEBSITE, NOT IN DETAIL, IT'S MORE OF A SUMMARY. SO YOU MAY NOT SEAT SPECIFICS RESEARCH OBJECTIVES IN THIS THERE THAT CAME THROUGHOUT PAIN STRATEGIC PLAN YEAR, BUT THEY'RE THERE. SO ONE I WANTED TEAMINGS, THAT WE'RE MOVING FORWARD ON. SO WHEN THE SECRETARY'S RESEARCH AGENDA CAME OUT. WE KIND OF LOOKED THROUGH AND WERE ASKED, WERE THERE SOME PROBLEMS THAT CAN GET STARTED IN 2017. AND I THINK THERE WAS A VERY NICE OPPORTUNITY, WHERE WE COULD WORK WITH SOME INVESTIGATORS, WHO HAVE ALREADY, A VERY LARGE PRAGMATIC TRIAL ON GOING, LOOKING AT INGRATED CARE FOR CHRONIC PAIN IN A PRIMARY CARE SETTING, WHERE THEIR HEALTHCARE SYSTEMS, WOULD GIVE THEM ACCESS TO A LARGE PATIENT COHORT THAT WAS ALREADY ESTABLISHED, AN ELECTRONIC HEALTHCARE RECORD SYSTEMS THAT WERE ALREADY IN PLACE. THAT WOULD MEET ONE OF THESE OBJECTIVES. SO DeBAR PRAGMATIC TRIAL, THEY ARE WILLING TO TAKE ON SOME NEW EFFORTS, RETROSPECTIVELIED TO THE TRIAL AND WE'LL BE WORKING TO TRY AND ANSWER AGAIN, SOME OF THE QUESTIONS, DIRECTLY FROM THE SINGLE'S AGENDA, THAT WAS RELATED TO THE NATIONAL PAIN STRATEGY. SO THIS WILL INVOLVE THIZE NORTHWEST HEADACHE SYSTEM GROUP HEALTH AND VETERAN'S HEALTH TO ADDRESS THE OBJECTIVE. AND VERY BRIEFLY, THEY'RE GOING TO USE PAIN-RELATED SURVEYS AND TO JUST SORT OF PULL QUESTIONS RELATED TO NATIONAL HEALTH INTERVIEW SURVEY, RELATED TO HIGH-IMPACT CHRONIC PAIN, AND THEY ARE ALSO GOING TO LINK UP THEIR ELECTRONIC HEALTHCARE DATA SYSTEMS TO PULL SOME INFORMATION ON THE PREVALENCE OF CHRONIC PAIN, ACROSS THE POPULATIONS, THE USE OF SERVICES ACROSS THE POPULATION AND BREAK THIS DOWN INTO SPECIFIC AREAS THAT WERE REQUESTED IN THE SECRETARY'S RESEARCH OF OBJECTIVES ..., FROM THE NATIONAL PAIN STRATEGY. SO WE'RE PRETTY EXCITED ABOUT THAT AND WE'LL GIVE AN UPDATE AS THAT WORK MOVES ALONG. A MEANS GET INFORMATION ABOUT STEPS THAT ARE MOVING FORWARD ON THE NATIONAL PAIN STRATEGY. SO WE NOW HAVE POSTED AND THE LINKS AREN'T LIVE YET, BUT IT'LL GIVE YOU A SAMPLE OF WHAT'S TO COME HERE. WE HAVE A WEB PAGE ON THE IPRCC WEBSITE THAT'S DEVOTE TO THE IMPLEMENTATION OF THE NATIONAL PAIN STRATEGY SO THIS JUST GIVE US YOU A PICTURE OF WHAT KIND OF INFORMATION IS UP THERE. THE INSTRUCT THAT YOU ARE TOM MENTIONED IN HIS PRESENTATION, IT LIFTS OUT HOW THE DIFFERENT LEVELS OF IMPLEMENTATION AT THE GOVERNMENT -- ON THE GOVERNMENT SIDE ARE STRUCTURED, SO YOU HEARD THAT THIS MORNING AND IT ALSO LISTS WHAT THE OBJECTIVES ARE IN THE NATIONAL PAIN STRATEGY, KIND OF AS A REMINDER, AND I THINK MOST IMPORTANT FOR THE FUTURE THESE ARE SOME SAMPLES THAT ARE IN THERE NOW, OF STEPS THAT OF COURSE TAKEN TO ADDRESS THE DELIVERABLES OF THE NATIONAL PAIN STRATEGY. SO YOU'VE HEARD ABOUT A COUPLE THEM HERE THIS MORNING. YOU'LL HEAR A LITTLE BIT MORE FROM RICK, FOR EXAMPLE. THEY'RE VERY BRIEF AT THIS POINT. WHAT WE HOPE OVER THE NEXT BIT OF TIME. ADD A LITTLE OF INFORMATION, WE'LL PROVIDE LINKS, FOR EXAMPLE, TO THE PAPERS THAT THESE REFER BACK TO OR THE STUDIES OR WEBSITES WHERE YOU CAN GET MORE INFORMATION. AND THEN AS WE SORT OF PULL TOGETHER THE INFORMATION THAT CAMOTES AND ALICIA HAS BEEN WORKING HARD ON THIS. THE INVENTORY OF EFFORTS GOING OACROSS THE GOVERNMENT. RELATIVE TOO, WE WILL ADD THOSE ON TO THIS WEB PAGE. SO AND YOU KNOW, WE HAVE TRIED TO GET IN INFORMATION OUT. WE'LL MAKE A BIGGEST, ONCE WE GET A LITTLE MORE DETAIL UP HERE TO LET PEOPLE KNOW, THEY'RE AVAILABLE AS A RESOURCE AND WE WILL KEEP IT AS UP TO DATE AS WE POSSIBLY K. HOPEFULLY, THERE WILL BE KINDS OF STUFF TO PUT UP THERE. IT'LL BE HARDTOPDATE. WE'LL TRY. WE HOPE. SO I'LL STOP HERE. IF ANYBODY HAS QUESTIONS SPECIFICALLY FOR TAD RELATED TO HEALTHY PEOPLE OR FOR DAVE, THEY'RE A LITTLE BIT MORE DEEPLY INVOLVED THAN I AM. >> LINDA. SO I HAVE A QUESTION ABOUT THE PATIENT PRESENTATIONS, THE EXAMPLES WHAT IT WASN'T CLEAR IS TO WHOM THEY WERE TARGETED AND I FELT BRING TUP BECAUSE MANY YEARS AGO, I USED TO ORGANIZE A SESSION AT THE AMERICAN PAIN SOCIETY CALLED THE PAIN PATIENT FOR THE BASIC SCIENTIST BECAUSE MOSTEST FUNDAMENTAL CLINICAL SCIENTISTS MAY NEVER SEE A PATIENT. WHAT WAS MOST INTERESTING, SO THE BASIC SCIENTIST SHOWED UP BUT THE ROOM WAS USUALLY FILLED WITH CLINICIANS BECAUSE MANY OF THEM DON'T SEE THOSE INTERESTING PATIENTS. IN THESE MODULES. THEY CAN BE DEDICATE TO THE CLINICIAN, THE BASIC SCIENTIST OR THE PUBLIC. AND I WONDER WHETHER IT'S TRYING TO DO ALL THREE OR THERE'S A WAY TO MEET THE NEEDS OF THE THREE DIFFERENT GROUPS. >> >> FARM ACE AND RELATED TRAINING. IT CAN BE USED FOR THE PUBLIC. IT'S OPEN FOR PUBLIC. IT CAN BE USED FOR CME. EACH MODULE WILL SAY WHO IT'S DIRECTED MOST FOR AND WE SAW, THERE WAS A NEED. NOT MUCH TRAINING ON PAIN IN THOSE SCHOOLS. SO WE WERE, INSTEAD OF JUST GOING TO CME, WE KIND OF NIPPED IT IN THE BUD IN A WAY AND TRIED TO MOVE INTO THAT SPACE. >> CERTAINLY, WE HAVE WAYS EACH MODULE IS FOCUSED ON A PATIENT. BUT THEN YOU GO TO RESOURCES AND PAPERS. THERE'S A PAIN PATHWAYS, MODULE. A SENDING, DESCENDING SORT OF THING. WE DON'T HAVE THEM EMBEDDED IN EVERY MODULE WE'RE GOING TO HAVE EACH MODULE IS FOCUSED ON A PARTICULAR PATIENT. >> [INDISCERNIBLE] >> SURE, THANK YOU, I HAD A QUESTION FOR CHAD. , I GUESS I WOULD JUST LIKE TO UNDERSTAND A LITTLE BIT MORE ABOUT WHERE WE'RE AT WITH THE COLLECTION THAT HAVE DATA SO I KNOW YOU'VE GOT QUESTIONS. THANK YOU MUCH FOR ALL YOUR WORK. YOU'VE GOT QUESTION IN THE INTERVIEW SURVEY. SO MY QUESTION IS FIRST OF ALL, IS INFORMATION BACK YET FROM THAT? AND THERE'S THE PIECE OF GETTING THEM IN, WHICH I'M SURE COST MONEY TO ADMINISTER THEM B. THEN THERE'S THE ANALYSIS PIECE TELEVISION, AND THE COMMUNICATION PIECE T. BOTH THE ANALYSIS AND COMMUNICATION PIECE ALSO COST A FAIR AMOUNT OF MONEY THE COMMUNICATION SIDE AS INN IMPACT. LIKE THE EDUCATIONAL PIECE. ET CETERA. SO WHERE ARE WE CAN THE DATA AND COMMUNICATION OF QUESTIONS YOU ALREADY ASKED. >> YOU HAVE TO HAVE AT LEAST TWO YEARS OF DATA, THAT'S WHY WE'RE COLLECTING IT IN 2016 AND 2017. THE DATA IS GENERALLY AVAILABLE SIX MONTHS AFTER THE CALENDAR YEAR. SO THE 2016 DATA WILL NOT BE AVAILABLE UNTIL NEXT JUNE OR JULY. AND THE ANALYSIS THAT, JOB RELATIVELY STRAIGHTFORWARD. JUST PREVALENCE ESTIMATES HERE: THE INTERESTING THING IS LOOKING AT OTHER FACT THAT'S RELATE TO THESE QUESTIONS AND THERE ARE A LOT OF QUESTIONS ISN'T NATIONAL HEALTH INTERVIEW SURVEY. A LOT OF DISEASE FACTORS, AND OTHER THINGS LIKE THAT. SO THAT'S A LITTLE MORE COMPLICATED AS FAR AS COMMUNICATING IT, WE HAVE THE WEBSITE. I DON'T THINK THERE'S ANY PLAN RIGHT NOW. I DON'T KNOW IF WE HAVE A PLAN FOR COMMUNICATING THINGS. BUT WE OFTEN DO AT CDC, HAVE A SUMMARY ARTICLE ON WHAT WE QUALITY MORBIDITY, MORTALITY, WEEKLY REPORT, WHICH IS SORT OF AN INHOUSE PUBLICATION AND ADVANTAGE S IT'S REVIEWED BY ALL THE MAJOR MEDIA.<$ TAB SO THEY CAN PICK UP ON THIS. AND YOU CAN SEE IT EVOLVING THROUGH THE COMMUNICATION SOMETIME. BUT THAT'S NOT GUARANTEED. IT'S T JUST DEPENDS ON WHAT'S HAPPENING THAT WEEK. SOMETHING BIG WOULD IN SOCIETY AND OUR ARTICLES GOT LOST. WE'LL HAVE TO THINK ABOUT HOW TO DO IS THAT. CAN I ANSWER ALL YOUR QUESTIONS. >> I JUST WANT TO MENTION, REALLY BRIEFLY, THAT THE PERSON BEHIND CINDY IS MARK PITCHER AND MARK DID A DETAIL IN MY OFFICE LAST YEAR, AND ACTUALLY SPENT A LOT OF TIME LOOKING INTO THE NATIONAL HEALTH INTERVIEW SURSAY, RELATED TO CHRONIC IN YEARS PRIOR TO WHERE WE HAD THESE MORE SPECIFIC QUESTIONS. AND I THINK AT SOME POINT, THE INFORMATIONALLY'S PUT TOGETHER, JOULE FIND, ONCE IT GETS IN A PUBLICATION, IS A REALLY IMPORTANT CONTRIBUTION, EVEN WITHOUT THE SPECIFIC QUESTIONS, JUST THE WAY HE WAS ABLE TO PULL OUT, YOU KNOW, THE THINGS WE NEED TO KNOW, FROM WHAT'S IN THERE BUT A DIFFERENT WAY. SO BACK TO SENDY. >> VITAL SIGNS IS SOMETHING THAT IS VERY PROMINENT. I KNOW MOST HEALTH DEPARTMENTS ADJOURN AMIST IT IS, HAVE THEIR ICE ON THE VITAL SIGNS REPORTS. I'M SURE THESE MUST BE SCHEDULED WAY IN V. HOW DO WE GET A VITAL SIGNS REPORT FROM CDC ON THE DATA THAT HAVE YOU AND THEN, AGAIN, I COULD WAIT FOR THESE QUESTIONS. THE SECOND ONE PIECE OF THAT, IS RICHARD NAHEEN HAS DONE SOME GREAT WORK WITH OLDER DATA THAT IT ON GOT GREAT PRESS, PARTICULARLY, A YEAR AGO, AUGUST. IT WAS WIDELY COVERED AND I'M WONDERING HOW HIS WORK RELATES TO THE INFORMATION -- CDC HAS SIGHT WILL SIGNS TO, BRING EVERYTHING TOGETHER AROUND IMPORTANT HEALTH TOPICS. THESE HAVE TO BE SCHEDULED FAR IN ADVANCE. THEY'RE VERY RIGOROUS AND DEMANDING. I'M NOT SURE HOW YOU GET ONE AT CDC ON PAIN PER SE. AND I'M A CDC REPRESENTATIVE BECAUSE I WORK IN THE THAT'S PROGRAM, PAIN AND OUTCOMES OF INTEREST. THERE MIGHT BE A BETTER CHANCE OF GETTING CDC VITAL SIGNS OR OPIATES, WE HAVE TO GET A LOT DATA TOGETHER, WHICH WE DON'T HAVE RIGHT NOW. SO IT'S SOMETHING TO THINK ABOUT IN THE FUTURE. WHEN IT'S A LITTLE MORE MATURE, IS A PUBLIC HEALTH PROBLEM. MAYBE NOT RIGHT NOW. YOU SAID RICHARD ARE MEAN, I'M NOT THAT FAMILIAR WITH HIM. THE ANALYSIS SHEETS WERE REFERRING TO USE OLDER NIHS DATA, AS WELL AS THE SUPPLEMENT AT NCHIS. AND THE USE OF INTEGRATIVE MEDICINE APPROACHES AND SO WE MADE PRETTY EXTENTSIVE USE OF THIS DATA. >> SO THAT WAS JUST PUBLISHED. AT LEAST SURPRISED ME. CAME OUT IN AUGUST OF 2015 AND IT WAS REALLY WELL COVERED IN THE MEDIA BUT HE'S VERY PRODUCTIVE EPIDEMIOLOGY, TURNING OUT A STEADY STREAM OF PAPERS ON PAIN AND COMPLEMENTARY APPROACHES AND INTEGRATIVE MEDICINE APPROACHES. WILL THE CHANGING PERSPECTIVE ON PAIN, AS THE FIFTH VITAL SIGN, AFFECT THE CHECKED OF THE INFORMATION WE NEED? ESPECIALLY IN THE ELECTRONIC HEALTH RECORDS. >> THAT'S A GOOD QUESTION. I DON'T REALLY HAVE A SENSE OF THAT. YOU KNOW, THE SURVEYS WE'RE USING ARE NOT USING IT AS A FIFTH VITAL SIGN. WE'RE JUST ASKING GENERALLY, ABOUT PAIN, AND THE QUESTION THAT IS SAW SO I DON'T HAVE A GOOD SENSE OF HOW THAT WORKS. OTHERS MAY HAVE A BETTER IDEA ABOUT THAT. INFORMATION HOW RECORDS ARE CAPTURED, IS INDIVIDUALIZED IN EHR SYSTEMS BUT WE ARE SEEING INCREASING UPTAKE OF THE PROMISE RELATED APPROACHES TO CAPTURING SOME OF THE QUALITY OF LIFE ISSUES, INCLUDING PAIN QUESTIONS BUT I THINK IT'S A VERY IMPORTANT AREA FOR THIS BODY TO CONTINUE PAYING ATTENTION TO. YOU'RE GOING TO HEAR A PRESENTATION LATER TODAY, FROM YOU JONI RUDER, ON PRECISION MEDICINE INITIATIVE. WE, IN THE PRECISION MEDICINE INITIATIVE, HAVE KEPT PAIN VERY HIGH ON THE LIST OF ISSUES TO COPYRIGHTER. BUTT ABILITY TO CAPTURE THIS INFORMATION WILL, OF COURSE, IN PART, DEPEND ON HOW THE VARIOUS VENDORS ARE APPROACHING PAIN ARE RELATED INFORMATION. IT'S AN AREA OF PUTTING RAPID FLUX AND CHANGE. BUT I THINK IT IS ONE THAT IS APPROPRIATE FOR CONTINUED DISCUSSION HERE. THERE WAS SOME FAN FAIR IN THE PAIN COMMUNITY WHEN, CDC BEGAN TO DIRECT DATA INFRASTRUCTURE DATA, I THINK IT MAY HAVE BEEN CDC. IT COULD HAVE BEEN THE NATIONAL HEALTH SURVEY. ON THE IMPACT OF CHRONIC PAIN. SO AT THAT POINT, CHRONIC PAIN WAS THEN MOVED UP TO HAVE THE SAME STATURE, IF YOU WILL, AS HEART FAILURE. I'M SURE YOU KNOW WHAT I'M TALKING ABOUT. THE HIGH IMPACT PAIN, IS NOT POSITIONED AS SOMETHING THAT JUST STARTED YESTERDAY, BUT BEFORE THERE WAS THE CURRENT CRISIS MENTALITY, THIS WAS IMPORTANT ENOUGH TO SURVEY AN IMPORTANT FRAMEWORK THROUGHOUT FEDERAL EFFORTS. STATISTICS, SOMETIMES THEY GET QUESTIONS LIKE THAT. THEY'RE BASED HERE IN WASHINGTON. DOWN IN ATLANTA WE MAY NOT KNOW THAT MUCH ABOUT IT. BUT I'M SURE THEY DID THAT. >> THANKS. THANK YOU MUCH. I THINK WE NEED TO MOVE O. WE HAVE CHRIS JONES ON THE PHONE. IF YOU CAN HOLD OI'M GOING TO DO A BRIEF INTRODUCTION. AND THEN HE'LL TALK TO YOU ABOUT ANOTHER PILOT STUDY THAT'S RELEVANT TO MOVING DELIVERABLES OF THE NATIONAL PAIN STRATEGY MOVING FORWARD. SO DR. JONES CURRENTLY SERVICE AS THE DIRECTOR OF DIVISION OF SCIENCE POLICY N THE OFFICE OF SECRETARY ASSISTANTANCE PLANNING AND EVALUATION. HIS OFFICE SERVES AS THE LEAD OF BIOMEDICAL SCIENCE HEALTH INITIATIVES. SO VERY IMPORTANT HE'S INVOLVED IN THE STEPS FOR IMPLEMENTATION. HE'S DIRECT AID NUMBER OF DIFFERENT AND VERY FORTUNATE HEALTHY LEVEL INITIATIVES ACROSS SEVERAL FEDERAL AGENCIES. HE SERVED AS SENIOR ADVISER IN OFFICE OF APPROXIMATELY PICTURE HEALTH STRATEGY AND A ANALYSIS. AND ON THE COMMISSIONER AT FDA. COMPLETED A DETAIL AT THE WHITE HOUSE. -- DURING THAT PARTICULAR DETAIL, HE WAS KEY TO DEVELOPING THE ADMINISTRATION'S 2011 PRESCRIPTION DRUG ABUSE PREVENTION PLAN. HE ALSO LED THE DRUG SAFETY AND RISK COMMUNICATION TEAM IN THE FDA CENTER FOR DRUG EVALUATION. SO HIS EXPERIENCE REALLY SPREADS ACROSS A NUMBER OF DIFFERENT AGENCIES THAT ARE RELEVANT TO THE PAIN STRATEGY. HE'S BEEN VERY SUPPORTIVE OF THIS STRATEGY, AND IS SERVING CURRENTLY ON THE IMPLEMENTATION STEERING COMMIT TOW KEEP IT MOVING FORWARD. SO CHRIS. YOUR SLICED ARE UP. AND I THINK YOU ARE ALL SET TO G. THANKS FOR JOINING US. >> CHRIS JONES: THANKS, LEND A. THANKS FOR THOSE FROM IN PERSON, AND WHO ARE ON THE PHONE. I ENJOYED HEARING THE CONVERSATIONS TODAY AND WANTED TO REITERATE FROM THE OFFICE OF SECRETARY LEVEL. BACK IN JULY, I WAS LEADING THE EFFORT OTHERS RESEARCH AGENDA, AND MADE A VERY CONSCIOUS DECISION TO TRY TO BLEND WHAT HAD BEEN HAPPENING IN THE OVER DOSE WITH THE NATIONAL PAIN STRATEGY. CLEARLY, VERY RELATED AND KNEW THAT THERE WERE TENSIONS THERE, THAT YOU KNOW, PEOPLE WERE ON THE MBS SIDE, VERSUS THE OPIOIDS SIDE. IT DIDN'T MAKE SEPTS. WE WERE ALL WORKING TOWARDS THE SAME GOAL. SO IT WAS AN INTENTIONAL EFFORT ON BEHALF OF THE DEPARTMENT TO SAY, YOU KNOW, WHAT WERE THE PRIORITY AREAS IN THIS LARGER SPACE THAT WE NEED TO BE WORKING ON AND WE DO HAVE, AS LINDA MENTIONED, THERE'S AN ISSUE BRIEF TYPE DOCUMENT THAT TALKS IN BROADER TERMS AS THE SYNTHESIS OF WHAT RESEARCH IS GOING ON. BUT WE DID ALSO CREATE ESSENTIALLY A SPREADSHEET OF DIFFERENT RESEARCH PROBLEMS THAT ARE BEING INTRAMURALLY DIRECTED EYE HHS STAFF OR INTRAMURALLY FUNDED ON THE WEBSITE CAN YOU SEE INDIVIDUAL STUDIES THAT ARE BEING DONE IN A VARIETY OF DIFFERENT DOMAINS IN THE OPIOID-BASED I DIDN'TS MISUSE. THE LARGER GOAL OF THE NATIONAL STRATEGY LET'S SEE, I WAS HOPING I'D BE ABLE TO ADVANCE MY SLIDES. SO THE REASONING THAT WE CONDUCTED THIS STUDY SO IN MATCH, THE CDC GUIDELINES CAME OUT. WE KNOW TARGET GUIDELINES, BOTH FROM NATIONAL ORGANIZATIONS, AS WELL AS STATES HAVE PUT OUT GUIDELINES REALLY, THE NATIONAL PAIN STRATEGY FOR CLINICIANS TO USE THE FULL COMPLEMENT OF TREATMENT. I THINK EVERYONE RECOGNIZES THERE HAS BEEN IN MANY CASES, AN OVER RELIANCE ON OPIOID-BASED I DIDN'TS AND WE NEED TO ENSURE, PROVIDERS KNOW WHAT TYPES OF TREATMENTS ARE AVAILABLE AND THOSE PAIN TREATMENTS ARE AVAILABLE AND ATTRACT COMES DOWN TO A QUESTION OF WHETHER OR NOT TREATMENTS ARE COVERED UNDER INSURANCE, AND WHAT IS THE EXTENT OF THAT COVERAGE. CERTAINLY F TREATMENTS ARE NOT COVERED OR THERE ARE SIGNIFICANT BALANCER SUCH AS MEDICAL NECESSITY CRITERIA OR PRIOR AUTHORIZES OR THERAPIES, THOSE TREATMENTS WILL BE UNDER UTILIZED MORE OR LESS LIKELY TO BE UTILIZED, ONLY AS FIRST-LINE THERAPY. WE ALSO RECOGNIZE N THINKING ABOUT THE STUDY THAT, WE DON'T REALLY KNOW A LOT AROUND CURRENT COVERAGE RAMIREZ TERES AND WE FELT FROM A POLICY PERSPECTIVE, HAVING THIS INFORMATION, COULD BE INFORMATIVE TO ENGAGE PUBLIC AND PRIVATE PAYERS, TOO THINK ABOUT HOW ARE WE COVERING THE VARIETY OF PAIN TREATMENT OPTION. THIS SLIDE REPRESENTS THE LIST OF FOLK WHO IS ENTER THED, SO A NUMBER OF FOLKS FROM NIH ARE IN THE ROOM TODAY. WE ALSO HAD -- FROM THE INJURY CENTER, JOHN COSTER, WHO'S THE CORRECTOR OF PHARMACY DIVISION AT MEDICAID, WITHIN CMS AND OUR HOPKINS COLLEAGUES WERE LEADING THE RESEARCH. ASK AND IT WASSA ROUGHLY A 12-WEEK PROJECT THAT WE UNDERTOOK THIS PAST SUMMER. SO THE DESIGN AND GOALS THE UNIVERSE OF TYPES OF PAIN IS LARGE AND CAN GET UNWEILDY, COCOVERAGE ALL TYPES OF PAIN Z. WE FOCUS ON TREATMENTS FOR ACUTE AND CHRONIC BACK PAIN, RECOGNIZING IT'S A VERY COMMON CONDITION AMONG PATIENTS AND THAT THERE ARE A VARIETY OF DIFFERENT TREATMENTS THAT MIGHT BE USEFUL FOR BACK PAIN. SO OUR GOALS TO DEVELOP A METHODOLOGY TO EXAMINE COVERAGE, POLICIES, SO THAT CAN INCLUDE BENEFIT PLAN SUMMARIES, FORMULARS FOR MEDICATION, CONVERSATIONS WITH PLANNED ADMINISTRATORS. TO BE ABLE TO EXTRACT OUT INFORMATION ON COVERAGE. WE HAD THREE PARTICULAR PROGRAMS IN THIS PILOT. WE WANTED TO A MEDICAID PROGRAM SO WE CHOSE A LARGE MEDICAID PROGRAM, MEDI-CAL. IN PARTICULAR FOR THE PILOT. WE'VE BEEN LOOKING AT FEE FOR SERVICE, BUT NOT THE MANAGED CARE. BUT THE FEE FOR SERVICE PROGRAM. WE LOOKED AT ANATHEMAS AN EXAMPLE OF A LARGE PRIVATE INSURER, AND CARE MARKETS AS A PRIVATE MANAGER SO WE'RE LOOKING AT THE MEDICATION SIDE. SO WE WANTED TO DETERMINE, HOW OPIOID-BASED I DIDN'T DIFFERS, AS WELL AS NONFARM LOGICAL TREATMENT, AND DETERMINE THE FEASIBLE OF CONDUCTING A NATIONAL LEVEL ASSESSMENT, BASED ON WHAT WE FOUND FOR THIS PARTICULAR ANALYSIS. FARM LOGICAL INTERVENTIONS THAT WE INCLUDED, OBVIOUSLY, A LARGE LIST OF DIFFERENT OPIOID PRODUCTS. I'LL JUST POINT OUT THAT WE DID INCLUDE METHADONE, BUT ONLY INCLUDED THOSE PRODUCTS WHERE THEY WOULD BE USE FORWARD PAIN. SO WE DID NOT INCLUDE THE BOXONE OR SUBSIDOL FOR OPIOID USE DISORDER AND METHADONE WOULD BE USE FORWARD PAIN BECAUSE IT CAN ONLY BE DISPENSED FOR OPIOID TREATMENT PROGRAMS. WE ALSO LOOKED AT A VARIETY OF OTHER MEDICATION THAT IS MIGHT BE USED FOR BACK PEN, SO A NUMBER OF NONSTEROIDS ANTOINE FLAM FLAMTORY DRUGS THAT ARE ON BRING. SO IT'S TRADITIONAL. NON-STORED AND CELEBREX. WE LOOKED AT AT NON-UPON STEROID MUSCLE RELAXANTS. LIGHT CAIN PATCHES. PREGAFF LYNN GAVAPINCIN. USE FORWARD BACK PAIN AND WE LOOKED AT A NUMBER OF [INDISCERNIBLE] THAT MIGHT BE USED FOR BACK PAIN. SO IN TOTAL, THERE WERE 64 DIFFERENT PRODUCTS THAT WERE INCLUDED. THIS SLIDE BASICALLY SHOWS WHICH PARTICULAR PRODUCTS WERE INCLUDED ACROSS THE THREE PROGRAM THAT IS WE LOOKED AT. SO MEDICAL, AND YOU CAN SEELY, THERE WERE 18 MOLECULES OF THE 64 PRODUCTS THAT WERE INCLUDED IN ALL THREE. AND THERE WERE EIGHT MOLECULES THAT WERE NOT INCLUDED IN ANY OF THE PROGRAMS. SO YOU CAN SEE HERE THEY KIND OF CUT ACROSS THE DIFFERENT CATEGORIES, DRUGS, AS FAR AS WHAT IS NOT COVERED. AND MANY OF THOSE IN PARTICULAR, THE NON-OPIOID ARE OFTEN TIMES, SORT OF FOLLOW-ON PRODUCTS OF PRODUCT THAT IS MIGHT BE AVAILABLE GENERICAL. SO CAN YOU SEE WHY, FROM A COST-PREP OF OF A PHARMACY BENEFIT MANAGER, THEY MIGHT THINK THEY HAVE GOT THAT PRODUCT ESSENTIALLY COVERED FROM OLDER PRODUCT THAT IS ESSENTIALLY WORK IN THE SAME WAY. WHEN WE LOOKING AT SPECIFIC PROGRAM, AGAIN, FOR THE PERCENTAGE OF PRODUCTS IN EACH CATEGORY ACROSS THE PROGRAMS THAT WERE COVERED, YOU CAN SEE THERE IS VARIATION IN HOW MANY OPTIONS ARE AVAILABLE. TYPICALLY, I WOULD SAY THE MEDI-CAL HAD A LITTLE BIT MORE RESTRICTED FORMULAR. FEWER PRODUCTS CHOOSE FROM ACROSS THE MAJORITY OF THE CATEGORIES, COMPARED TO ANTHEM OR CBS CAREMARK AND GENERALLY, THERE WERE PRODUCTS AVAILABLE FAULT CATEGORIES WITH THE EXCEPTION OF [INDISCERNIBLE]. NOTICE THE PRODUCTS WE EXAMINED WERE COMPED UNDER THAT FORMULAR. WHEN WE LOOKING AT SOME OF THE UTILIZATION MANAGEMENT TYPES OF PROGRAMS THAT AN INSURER OR PVM MIGHT PUT IN PLACE, NON-OPIOIDS ARE WE LIKELY FOR A YOU -- CAN YOU SEE,A THERE'S VARIATION, MORE PARODY IF THE ANTHEM PROGRAM AROUND PRIOR AUTHORIZATIONS. YOU CAN Z IT'S SORT OF FLIPPED BETWEEN MEDICAL AND CBS CARE MARK WHERE THERE ARE MORE PRIOR AUTHORIZATIO FOR OPIOID, THAN NON-OPIOIDS, AND THE REVERSE FOR MEDI-CAL. CAN YOU SEE PRETTY LOW UTILIZATION OF SET THERAPIES ONLY 5% OF THE PRODUCTS FOR NON-OPIOID, AND THE ANTHEM PLAN AND CBS AND CARE MARK DID NOT HAVE ANY. AND THE MEDICATE PROGRAM OR SOME OF THE OPIOID DURATION LIMIT. CAN YOU Z THE GENERAL THEME IS THAT THERE'S VARIATION ACROSS THE PROGRAM. WHEN WE LOOKED AT THE NONFARM LOGICAL INTERVENTIONS, YOU CAN SEE HERE, WE LOOKED AT A PRETTY BROAD RANGE. I'M NOT GOING TO GO THROUGH ALL OF THOSE, THAT HAVE ACCESS TO THE SLIDE. THIS IS THE BREAK DOWN FOR HOW DO YOU GET COVERAGE AND WHAT TYPE OF COVERAGE CAN YOU GET IN THE MEDICAL PROGRAM FOR A NONFARM INTERVENTION, I'LL START WITH SAYING, THERE WERE A NUMBER OF NONFARM LOGICAL PATIENTS THAT WERE NOT COMPED AT A. SO BIOFEEDBACK. STIMULATION. TRIGGER POINT INJECTIONS. CBT, YOGA AND TENS WERE NOT COMPED UNDER THE MEDI-CAL PROGRAM. AND FOR THE OTHER PHYSICAL THERAPY. ACPUNKURE, CONTRACTIC CARE, SPINAL NEUROSTIMULATION. THERE IS VARIATION IN WHAT TYPE OF AUTHORIZATION IS REQUIRED, IS THE PRESCRIBEER A PARTICULAR TYPE OF PRESCRIBEER REQUIRED TO RECOMMEND OR SIGN OFF ON IT, WHO HAS TO APPROVE IT YOU KNOW, FOR CYTOMURAL STIMRATION, YOU HAVE TO HAVE TRIED SOME OTHER THINGS BEFORE IT'S COVERED. THERE ARE COVERAGE LIMITS, BOTH DURATION AND QUANTITY, FOR PHYSICAL THERAPY AND QUANTITY FOR SOME OF THE OTHERS AND THEN SOME OF THE SPECIFIC LIMITS ARE IN THE LAST COLUMN. WHERE YOU CAN SEE HERE, IN SOME INSTANCES, LOOKS LIKE THE LIMITS ARE NOT NECESSARILY CONSISTENT WITH FULLY ADDRESSES THE PATIENT NEED. WHEN WE COMPARE TO ANTHEM, CAN YOU SEE HERE, THE MAJORITY OF THE INTERVENTIONS REQUIRE MEDICAL NECESSITY DEMONSTRATION. SOME HAVE SORT OF A FAIL-FIRST OR STEP THERAPY POLICY. A FEW OF THEM REQUIRE SPECIFIC AUTHORIZATION AND THEN THEY DO HAVE SOME LIMITS AND AGAIN, BIOFEEDBACK, COGNITIVE BEHAVIORAL THERAPY AND I DON'T GO ARPNOT COVERED UNDER THE EIGHTEEN ANTHEM PROGRAM. AND THOSE WERE SIMILAR TO ONES THAT WERE NOT COVERED UNDER MEDI-CAL. WHAT DATA SERVICES ARE AVAILABLE. AND SMALL SAMPLE SIZE. WE'RE NOT ATTEMPTING TO GENERALIZE THIS TO ANYTHING. BUT WE DO, WE DID FIND OUT ALSO THAT SOME OF THE PUBLICLY AVAILABLE SITES DO NOT PROVIDE AS MUCH DETAIL AS WE'D LIKE. ONE OF THE REALLY THINGS WE WOULD LIKE TO LOOKING AT IS CO-PACE VERSUS CO-INSURANCE, ESPECIALLY LOOKING AT FARM LOGICAL, VERSUS NONFARM LOGICAL INTERVENTIONS. IF PATIENTS CAN GO AND PAY $15 FOR CO-PAY FOR OPIOID, YET THEY'RE PAYING 25 CO-PAY FOR OCCUPYINGAL THERAPY, THERE ARE BARRIERS TO UTILIZING THOSE TYPES OF TREATMENT SOCIOLOGY WE'RE NOT ABLE TO LOOKING AT THAT IN THIS PARTICULAR ANALYSIS. PARTLY, BECAUSE IN ORDER TO GET THAT INFORMATION, WE NEEDED TO IDENTIFY VERY SPECIFIC PLANS AND THAT WAS JUST NOT WITHIN THE SCOPE OF THIS MIGHT. WE WERE LIMITED TO CONDUCT INTRODUCE DURING THE SHORT PILOT STUDY, ALTHOUGH WE DID TALK TO SOME PLAN ADMINISTRATORS, ON HOW DECISIONS ARE MADE. SO THE CONCLUSIONS IN THE SMALL SAMPLE, WE DID SEE VARIATION IN COVERAGE FOR AMATEURS, ACROSS ALL THREE PROGRAMS. SOME, NONFARM LOGICAL LOGICAL INTERVENTION THAT IS HAVE UTILITY FOR BACK PAIN, WERE NOT COMPED AT ALL EITHER AS THE MEDICAL PLANS, THE MEDICAID OR PRIVATE INSURANCE PLAN. THERE ARE DETERMINATIONS OF MEDICAL NECESSARY NECESSITY FOR MANY OF THE NONFARM LOGICAL THERAPIES, FOR EFFECTIVE BARRIERS USING THESE TREATMENTS. WE FEEL WE HAVE DEVELOPED A METHODOLOGY THAT CAN BE USED IN THE FUTURE. AND INFORMATION COULD DRIVE EFFECTIVE POLICY. WE'RE NOW IN CONFERSES WITHIN HHS AND HOPKINS AS WELL, TOO COME UP WITH SAMPLING STRATEGY TO DO THIS AS A NATIONAL LEVEL. WE COTHINK THIS IS REALLY IMPORTANT. BOTH IN THE CONTEXT OF, YOU KNOW, OPERATIONALLIZING THE CDC GUIDELINES, BUT REALLY, MORE BROADLY NN MAKING SURE THAT AS A DEPARTMENT, WE ARE INTERESTED IN INSURING BROAD ACCESS TO PAIN TREATMENT. YOU KNOW, WE NEED TO MAKE SURE THAT THERE IS COVERAGE OF THE TREATMENTS, AND THAT WE CAN ENGAGE AND DO IT IN A DATA-DRIVEN BASED WAY. AND SO WE ARE IN THE INITIAL DISCUSSIONS OF SCALING UP. SO HOPEFULLY, AT SOME FUTURE DATE, I CAN COME BACK AND TALK TO YOU ABOUT SOMETHING THAT IS MORE GENERALIZABLE THAT, HAS MORE DETAIL ON THE CO-PAY, CO-INSURANCE ISSUE AND THAT CAN REALLY HELP MOVE THE CONVERSATION FORWARD. I WILL STOP THERE. THANK YOU V. >> THANKS, CRITS AND THANK YOU FOR KEEPING THE NATIONAL PAIN STRATEGY IN THE SPOTLIGHT. MOST APPRECIATED. >> VERY USEFUL INFORMATION AND WE'RE INTERESTED AS YOU DEVELOP STRATEGIES TO BROADEN THE REACH. I AM SURPRISED THAT CBT ISN'T PAID FOR ANYWHERE. >> IN THOSE TWO PLANS, IT IT WASN'T I KNOW THAT IN SOME CONVERSATIONS WITH COLLEAGUES AT CMS, IT CAN SOMETIMES BE BURIED, AND LADDER TO FIND. BUT IN THE DOCUMENTS THAT -- I KNOW IT CAN BE BURIED AND HARD TO FIND. >> YOU DIDN'T LOOKING AT AFTIO PATHIC SPINAL MANIPULATION. BUT ONLY CHIROPRACTIC SPINAL MANIPULATION. IS THAT CORRECT. >> I BELIEVE Z YES. >> SO IT'S GOING TO BE VERY INTERESTING, AS YOU DIVE DEEPER. I DO AGREE, THE OVERALL COVERAGE ISSUES MAY NOT BE ACCURATELY REPRESENTED AT THE FIST LIST, BUT THIS IS VERY INFORMATIVE. THANK YOU. >> Walter Koroshetz: CHRIS, THIS IS WATER. I WAS ASKING N DISCUSSIONS WITH SAY, ANTHEM OR EVEN MEDI-CAL, IS THERE A DATABASE CAN YOU GET DATA STORAGE DATA UTILIZATION ON THESE, IN TERMS OF, YOU KNOW, HOW FAR OFTEN THEY'RE PRESCRIBED PRESCRIBED. >> AS PAYERS, THAT WOULD HAVE ACCESS TO SOME OF THAT, DEPENDING ON HOW TELL BUILT IN CLAIMS. THINKING ABOUT TAKING TO A NATIONAL LEVEL, WOULD BE ALSO TO THINK ABOUT DOING SOME QUANTITATIVE ANALYSES TO LOOKING AT WHAT IS AVAILABLE UNDER COVERAGE. WHAT IS PROVIDE. AGAIN, THAT WAS OUTSIDE OF THE SCOPE OF THIS IT MIGHT BE A CONVERSATION WE HAVE, EITHER DIRECTLY WITH SOME OF THE INURE SUREERS DIRECTLY AS A COLLABORATION EXAMINING THAT, OR IF WE GO AFTER OTHER DATA SOURCE LIKE MARKET DATA OR POTENTIALLY, DMS DATA THAT WE HAVE ACCESS TO HERE, WITHIN HHS TO ANALYZE. BUT I THINK IT REALLY WOULD NEED TO BE ON A PLAN BY PLAN BASIS OR A BOOK OF BUSINESS BASIS. SO I THINK IT WILL LIKELY REQUIRE SOME COLLABORATION AMONG THE INSURER THAT IS WE EXAM. >> YOU MAY SEE A SLIGHTLY DIFFERENT PERSPECTIVE ON, I KNOW, THE BARRIER THAT IS A PATIENT OR ENROLLEE FACES W RESPECT TO REIMBURSEMENT, COPAYMENTS, ET CETERA THAT, MAY BE DIFFERENT THAN WHAT YOU SEE IN YOUR CURRENT DATA S. SO DO YOU FEEL THAT WOULD BE POSSIBLE AND THEN THE SECOND QUESTION I HAVE IS, YOU KNOW, MANY OF THE MODALITIES THAT ARE BEING ASSESS HERE, PHARMACOLOGICAL AND NON-PHARMAO LOGICAL ARE USED TO TREAT SEVERAL PERSISTENT PAIN CONDITIONS. I WOULD HOPE ONE TRIES TO GENERALIZE THIS BEYOND LOWER BACK PAIN, BUT TRIES TO DEVELOP, I THINK, OUTCOMES THAT MAY INFORM A LARGER SEGMENT OF THE PAIN COMMUNITY. IN THE MEDICATION SPACE, THERE'S NO WAY FOR US, IT'S VERY DIFFICULT FOR US TO TEASE OUT THE COVERAGE FOR AMATEURS, SPECIFICALLY F ARE BACK PAIN. SO QUANTITY LIMIT THAT IS THERAPIES APPLY TO THE DRUG, NOT NECESSARILY THE INDICATED USE. SO THERE IS SOME GENERALIZABILITY THERE. IN SOME OF THE NONFARM LOGICAL INTERVENTIONS, THERE WERE IN PARTICULAR, THINGS FOR BACK PAIN, VERSUS OTHERS. BUT I AGREE, IF WE'RE PUTTING THE TIME IN TO EXAMINING THIS, UNDERSTANDING WHERE THIS IS APPLICABLE MORE BROADLY THAN BACK PAIN WOULD CERTAINLY BE PENITENTIARY. I THINK PART OF WHY WE LIMIT TODAY TO BACK PAIN, WE'RE THINKING ABOUT THINGS LIKE MIGRAINE WHICH TAKE ON A DIFFERENT UNIVERSE. SO WE THOUGHT THIS WILL BE A MANAGEABLE FIRST PATH. THE PART ABOUT TALKING TO PATIENTS, I AGREE, THAT WOULD BE INFORMATIVE. THE CHALLENGE FOR US AT THE FEDERAL LEVEL, WE'RE SUBJECT TO PAPERWORK REDUCTION ACT LIMITATIONS FOR HOW WE CAN TALK, HOW MANY PEOPLE WE CAN TALK TO THERE'S A PROCESS FOR RESEARCHING A PACKAGE, TALK TO LARGER NUMBER OF PEOPLE AND THAT ADD ACE TIME COMPONENT, THAT IS SOMEWHAT INCONSISTENT AND UNPREDICTABLE. SO I THINK WE HAVE TO BE CREATIVE ABOUT HOW WE MIGHT GET SOME OF THAT INFORMATION OR THINK ABOUT WHETHER OR NOT, THAT'S SOMETHING THAT RESEARCH PARTNERS OUTSIDE OF THE GOVERNMENT MIGHT TAKE ON IF WE'RE DOING ONE PART OF THIS, AND THERE'S AN INTEREST AMONG OTHER RESEARCHERS THAT DON'T HAVE THE SAME CONSTRAINTS AND THAT MIGHT BE A WAY TO GO ABOUT GETTING THOSE ANSWERS. >> THANK YOU. JUST CURIOUS IF YOU HAVE A GUT SENSE IF YOU LOOKED AT MEDICATE FROM A DIFFERENT STATE. >> I WOULD IMAGINE, THEY WOULD PROBABLY BE VERY DIFFERENT. YOU'VE SEEN ONE MEDICAID PROGRAM, YOU'VE SEEN ONE MEDICAID PROGRAM. AGAIN, THAT'S WHY WE'RE THINKING OF A LARGER NATIONAL LEVEL SAMPLING STRATEGY, THINKING ABOUT HOW DO WE IDENTIFY PROGRAM THAT IS WE THINK WILL GIVE US A COLLECTIVE VIEW OF WHAT'S GOING ON. >> YEAH, THE QUESTION WAS REALLY RHETORICAL. >> Announcer: PLEASE PARDON THE INTERRUPTION IF YOU WOULD LIKE TO CONTINUE, PRESS STAR 1 OR THE CONFERENCE WILL BE TERMINATED. >> SO CHRIS, I WAS WONDERING IF YOU HAVE ANY CHANCE TO TALK TO THE PEOPLE TO MAKE A DECISION AND THE INSURERS THEMSELVES, AND WHETHER THEIR OUTCOME MEASURE MAKES A DIFFERENCE, WEATHER THERE ARE PRESENCE EVIDENCE-BASED MEDICINE APPROPRIATE IN APPROPRIATE CONTROL CHARGE MAKE A DIFFERENCE. HOW DO THEY MAKE A DECISION ON THEY'RE GOING TO PAY? IS IT ARBITRARY OR DOES IT HAVE ANY SCIENTIFIC CONCEPT OF THAT. >> I MISSED YOUR QUESTION, BECAUSE WE HAD AN ANNOUNCEMENT ABOUT EXTENDING THE CALL B. IT SOUNDED LIKE YOUR QUESTION WAS ON PLANS TO GET IT COVERED. >> MY QUESTION WAS ABSENCE OF ABSENCE OF CONTROLS ON EVIDENCE-BASED MEDICINE, OR OUTCOME OF TREATMENT, MAKES A DIFFERENCE IN HOW THEY MAKE A DECISION. HOW DO THEY MAKE A DECISION WHAT THEY ARE GOING TO PAY AND WHAT THEY ARE NOT GOING TO PAY? >> I THINK THAT'S EXACTLY PART OF WHAT WE WANT TO DO IN THE FOLLOW UP. REALLY UNDERSTAND, WHAT'S THE EVIDENCE THRESHOLD, HOW DOES PARTICULARLY, THE DRUG SPACE LIKE REBATE, CHARGE-BACKS, HOW DO THOSE THINGS LINE UP WITH WHAT'S COVERED, WHAT'S AVAILABLE FOR PATIENTS, AND IN THIS PARTICULAR, WE DIDN'T GET INTO A LOT THAT. WE DID HAVE ALIMENTED NUMBER OF CONVERSATIONS WITH PLANNED ADMINISTRATORS AND -- IT VARIES MANY PEOPLE USE A PNT COMMIT OAT PATIENT'S SIDE. I WOULD SAY, IT'S A MORE STRUCTURED APPROACH TO MAKING TERMINATIONS, NOT ALWAYS BASED ON SCIENCE, BUT BASED ON REBATES AND OTHER DRUGS THAT ARE IN THE PARTICULAR DRUG CLASS THAT ARE SAY. WE REALLY THINK IT'S IMPORTANT, WHICH I THINK ALSO LEAD TO THE NEXT SPEAKER WHICH IS WHY HRQ WERE REALLY INTERESTED IN A SYSTEMATIC REVIEW OF THE EVIDENCE FOR NONFARM LOGICAL INTERVENTION BECAUSE WITHOUT THAT INFORMATION, IT'S DIFFICULT TO GO INTO AN INSURER TO SAY, YOU'RE NOT COVERING THIS, BUT IT'S GOT, YOU KNOW, SUPPORTED BY THE EVIDENCE THAT IS USEFUL IT'S AN AREA WE WANT TO CONTINUE TO BETTER UNDERSTAND. >> SO WE HAVE SOME MORE QUESTIONS. >> I THINK THEY'RE STILL KEEPING IT THAT PATH OF PATIENT, RATHER THAN AN ACTIVE PARTICIPANT IN HEALTHCARE AND THAT BOTHERS ME A LOT. I'VE SEEN EVIDENCE-BASED GUIDELINES MAY CLAIM TO BE EVIDENCE-BASED BUT I'VE HAD THE EXPERIENCE WHERE IN HRB. PEOPLE WHO DRAFTED THE GUIDELINES, WITH IMPLEMENTERS, WHO SAID THEY WERE IMPLEMENTING THE GUIDELINE, AND THE DRAFTER SAID, ACTUALLY WHAT YOU'RE IMPLEMENTING IS INCONSISTENT WITH WHAT, WE'RE UPON RECOMMENDING IN THE GUIDELINE. I THINK KATHY WAS THERE WE HAD A MEETING WITH AN INSURURE THAT EITHER DIRECTLY OR INDIRECTLY COVERED 60 MILLION LIVES AND THEY GAVE US AN EXAMPLE OF THEIR GUIDELINE AND THEY CALLED IT QUOTE, CHRONIC REGIONAL PAIN SYNDROME, UNQUOTE, COMES NOT EXACTLY RIGHT. IF THERE'S A DEEM A THEY GET CERTAIN NUMBER OF POINTS. ATTARRED HAIR GROWTH THEY'RE GET A CERTAIN NUMBER OF POINTS, AND WE WERE STRUCK BY HOW REMARKABLY DETAILED THIS WAS. AND WE ASKED, HOW WERE THEY ABLE TO DO THIS. THEY SAID WE'RE VERY PROUD, WE'RE ABLE TO DO THIS UNDER BUDGET. WE GET POST CALL RESIDENTS INTERNAL MEDICINE, PAY THEM $50 AN HOUR AND THEY ASSEMBLE THESE DETAILED GUIDELINES. SO ACTUALLY, IN KEEPING WITH THE NOTION WHEN, LOOKING AT CERTAIN META ANALYSIS. THERE ARE FUNDAMENTAL FLAWS IN HOW THE DATA IS ABSTRACTED FROM THE INITIAL PAPERS. THIS IS A REAL POTENTIAL AREA OF DISCUSSION AND SHORT FALL SAYING THERE'S A SCIENTIFIC OR EVIDENTIAL RYBASIS. >> THANKS DAN, I THINK THAT'S AN IMPORTANT COMMENT. >> CINDY. >> THIS IS SENDY. THANKS A LOT FROM ALL OF YOUR WORK. I WANT TO KNOW FROM YOU, WHETHER ANY OF THIS IS PUBLISHED OR PLANNED TO BE PUBLISHED. THE SECOND POINT I WANT TO MAKE IS A LOT OF THIS COVERAGE COMES AT THE STATE LEVEL AND I HAD TO WRITE A PIECE, A LITTLE COMMISSION TO LOOKING AT WHAT IS COVERED BY INSURANCE AND NOT IN TERMS OF NONFORM FARM LOGICAL LOGICAL TREATMENTS AND -- NON-PHARMA LOGICAL TREATMENTS AND LOOKING AT TWICE INCREASE ACCESS, LARGELY, THROUGH LEGISLATION. SO IT'S LOOKING AT THIS ACROSS OUR STRAIGHT AND HHS SECRETARY HAS ENLISTED THE DIVISION INSURANCE, AS WELL AS CHIA. A GROUP IN MASSACHUSETTS THAT LOOKS AT DATA SOMITE LOOKING AT, PERHAPS, WHAT'S GOING ON SOME SOME OF THE STATES AND I'M HAPPY TO CONNECT WITH WITH THIS COMMISSION, LOOKING AT THIS. SOME OF THE ACTION MIGHT BE AT THE STATE LEVEL AND I'M NOT SURE IF YOU'RE AWARE OF THAT. >> GENERALLY, RERECOGNIZE THAT A LOT OF THIS IS BEYOND FEDERAL LEVERS. WE HAVE SOME LEVERS TO INFLUENCE THAT. MEDICAID DIRECTOR LETTERS OR CALL LETTERS FROM MID CARE, THOSE TYPES OF THINGS, BUT THAT REALLY YOU KNOW, A LARGE PART OF WHY WE ARE UNDERTAKING WORK IS JUST TO GET THE INFORMATION OUT THERE. SO THAT PEOPLE WHO ARE, YOU KNOW, WHO DO HAVE OTHER LEVELS TO IMPLEMENT THIS CAN USE IT TO HELP DRIVE THEIR PROCESS. I SERGEANT WOULD BE HAPPEN, IN GIVING DETAILS. AS FAR AS IS THIS PUBLICLY AVAILABLE OR PUBLISHED ANYWHERE, NO, IT'S ON MY LONG LIST OF THINGS TO WRITE UP. SO MAYBE AFTER THE ELECTION, IT WILL BE A LTLE BIT SLOWER AROUND HERE AND I'LL HAVE TIME TO DO T. IT'S A SMALL SAMPLE. WE JUST FELT LIKE UNDER TAKING THE WORK WAS RELEVANT, TOO A VOTER OF PEOPLE IN THE SAME COMMUNITY SO WE WERE THINKING ABOUT SUBMITTING TO A JOURNAL OR SOMETHING TO, SAY, THIS IS WHAT WE FOUND. S IN THE METHODOLOGY THAT WE USE, TOO MOVE FORWARD. >> MY QUESTION VERY GOOD THE CLASSIFICATION. DID YOU HAVE A CHANCE TO BREAK THEM INTO TIER 1, 2 AND 3. TIER 3 IS PRETTY MUCH UNCOVERED. HAVE YOU TO LOOK FOR PREAUTHORIZATION, TRY OTHER MEDICATIONS AND APPEALS. PERHAPS IT'S ALSO TO BREAK THEM UP. YEAH, SO WE HAD THAT TO A LITTLE EXTENT. UNDERWENT THE MEDICAL PROGRAM, FLOWER NO TIERS. ON THE CBS PLAN, WE'D A LITTLE BIT OF THAT. ONLY, MOST OF THE GENERIC PRODUCTS, ABOUT THE MAJORITY OF THE OPIOIDS ARE IN TIER 1. WHAT DIDN'T V WE DIDN'T HAVE THE ABILITY TO DISTINGUISH WHAT WERE THE DIFFERENCES IN THE TIERS, AS FAR AS, YOU KNOW, TIER 3 OR TIER FOUR. IS A HUNDRED DOLLARS CO-PAY. AND THOSE TYPES OF THINGS. SO THAT WAS AGAIN, SORT OF THE LIMITATION OF THE CATATHAT WE HAVE AT HAND, BUT WOULD BE KEY IN MOVING FORWARD. >> THANK YOU FOR JOINING US, CHRIS, WE APPRECIATE YOU CALLING IN AND ANSWERING ALL THESE COMPLICATED QUESTIONS. >> HAPPY TO DO T. THANKS. >> >> Linda Porter: OKAY. WE'RE GOING TO MOVE TO RICK, WHO'S A MEMBER OF OUR COMMITTEE, THE HRQ REPRESENTATIVE AND HE'S GOING TO TELL US ABOUT A SYSTEMATIC REVIEW THAT'S COMING UP. RICK THANRICK THANK YOU.LIND A. IT'S A PLE ASURE TO BE HERE AND BRING YOU TO YOU DATA STORAGE, AS SOMEONE WHO HAS WHO IS IN FEDERAL SERVICE, I WOULD BE REMISS IF I DIDN'T BRING UP TO THOSE OF YOU WHO ARE KNOT IN FEDERAL SERVICE, THE TREMENDOUS EFFORTS OF WALTER, PLEDGA AND CHER ES TO MAKE THIS HAPPEN. -- WALTER, LINDA AND CHER ES TO MAKE THIS HAPPEN. WHAT YOU DON'T SEE A LOT WHAT GOES BEHIND THE SCENES TO MAKE THIS HAPPEN. I APPRECIATE WORKSHEET, AND ALSO, THANK YOU T-- I APPRECIATEYOUR WORK AND ALICIA. MANY OF YOU DON'T SEE WHAT IS DONE TO MAKE THIS HAPPEN AND PULL TOGETHER SOME OF THE INITIATIVES NOT ONLY -- IT'S A WITHIN GROUP AND BETWEEN GROUP STUDY HERE NOT ONLY WHAT'S HAPPENING WITHIN HM-MM BUT ALSO WHAT'S HAPPENING OUTSIDE OF NIH IT'S A -- NOT ONLY WHAT'S HAPPENING WITHIN NIH BUT WITH OTHER COMMUNITIES. WHAT I'D LIKE TO DO AS TO GIVE A BRIEF OVERVIEW FOR THOSE NOT FAMILIAR WITH ARC AND TALK ABOUT SOME OF THE INITIATIVE THAT IS RELEVANT TO THE WORK THAT YOU ARE ALL DOING. SO OF GREAT NEWS TO US, AS WE HAVE A NEW DIRECTOR. DR. ANDY BIMAN WHO COMES TO US BY UFF. HE'S A PRIMARY CAROLYN EDUCATION AND AIR, VAST EXPERIENCE WITH HEALTH POLICY AND PUBLIC POLICY AT THE STATE AND FEDERAL LEVEL. SO HE'S A COMPLETE PACKAGE FOR US. HE COMES AND WHAT YOU SAW FROM LENDA'S PRESENTATION. MUCH OF WHAT TAKES PLACE IN TREATING CHRONIC CARE ISN'T PRIMARY CARE. SO I WILL HAVE VERY LITTLE DIFFICULTY, CONVINCING ANDY OF THE IMPORTANCE OF WORK WE'RE DOING HERE AND HOW IMPORTANT IT IS FOR US TO BE ENGAGED IN AS MUCH AS WE CAN TO MOVE THE I. IMPLEMENTATION OF THE NATIONAL PAIN STRATEGY FORWARD. HE GETS IT. BOTTOM LINE, HE GETS IT. HE GETS THE BALANCER OF WHAT WE'RE DOING AND I THINK WE COULD OPERATIONALLIZE THAT IT'S BEEN GREAT, SINCE ABOUT APRIL, I BELIEVE IS WHEN HE CAME ON BOARD. SO ARC'S ROLE IS TO PRODUCE EVIDENCE TO MAKE HEALTHCARE SAFER, HIGHER QUALITY, MORE ACCESSIBLE. EQUITABLE AND AFFORDABLE AND TO WORK WITH HHS AND YOU ALL, TO MAKE SURE THE EVIDENCE, LIKE THE NATIONAL PAIN STRATEGY UNDERSTOOD AND USED ARC HAS RESEARCHERS LOOKING AT PRACTICE LEVEL AND SYSTEMS LEVEL TO MAKE IMPROVEMENTS IN QUALITY AND SAFETY. WE ALSO DO SYSTEMATIC REVIEWS IN EVIDENCE, ONE OF WHICH I'M GOING TO BE REPORTING ABOUT TODAY AND THEY'RE PUBLIC THROUGH THE EFFECTIVE HEALTHCARE WEBSITE AND AGAIN, I'LL MENTION THAT. WE CREATE MATERIALS TO TEACH AND TRAIN HEALTHCARE SYSTEMS AND PROFESSIONAL, METABOLIZE IMPROVEMENTS IN CARE. I'M SURE YOU'RE ALL FAMILIAR WITH HICK HICK ASSOCIATED INFECTIONS AND THE IMPROVEMENTS TO REDUCE MORBIDITY AND MORTALITY AROUND IT IS AREA. ANOTHER EXAMPLE IS TEAM STEPS, PARTNER WEALTH D.O.D. TO USE A WIDESPREAD AND MUCH USED TOOL CUTS AROUND HOW OPTIMIZE AND DEVELOP STRONG TEAMS AND HEALTHCARE AND HOW THAT CAN BE THEN MOVED TO IMMUNE CELL PROVING QUALITY AND SAFELY AND GENERATES MEASURES AND DATA TO ATTACK AND IMPROVE PERFORMS. A GOOD EXAMPLE COULD BE USED FOR RESEARCH IN THE PAIN COMMUNITY, MEDICAL EXPENDITURE PANEL SURVEY, WHICH IS A RANDOMIZED NUMBER OF AROUND 10-12,000 HOUSEHOLDS IN THE U.S., TWO-YEAR COHORTS AND I'M SURE MANY ARE FAMILIAR WITH MAPS AND THERE ARE QUESTIONS AROUND QUALITY OF LIFE AND PAIN THIS IS RANDOMIZED. IT'S AVAILABLE. MANY OTHER EPIDEMIOLOGIES HAVE USED MAPS TO EVALUATE PRE-ACA, POST-ACA. PREIMPLEMENTATION OF A NATIONAL INITIATIVE. >> PROFESSOR: , SO THIS WOULNICHE -- PRO, SO THIS COULD BE ONE OPPORTUNITY TO LOOK AROUND PAIN. AND AGE CUP DATA, WHICH IS HOSPITAL UTILIZATION AT THAT TIME D DATA, JUST TWO PERFORMS. OKAY. GETTING US TO THE REASON I WAS ASKED TO PRESENT IS THROUGH INITIATIVES FOR CDC AND OUR COLLABORATIONS WITH ARC THERE WAS INTEREST IN DOING A SYSTEMATIC REVIEW. WHAT WERE THE BENEFITS AND ARMS OF NON-PHARMAO LOGICAL THERAPIES AND ADULTS WITH CHRONIC PAIN, DUE TO THE CONDITIONS THAT ARE LISTED THERE THE EFFECTIVE HEALTHCARE PARTNERS WITH EVIDENCE-BASED PRACTICE CENTERS. SEPARATE AND DISTINCT FROM THE FEDERAL GOVERNMENT. AND I KNOW THE QUESTION OF BIAS HAS COME UP TODAY. AND ONE OF THE TREENS TRY AND MINIMIZE BIAS IS TO PARTNER WITH INDEPENDENTAGE THAT IS DO THE ACTUAL SYSTEMATIC REVIEW ON THEIR OWN. FULL STEAM AHEAD, THEY'RE INVOLVED AND THEY DO T. THERE'S RELATIVELY LITTLE GOVERNMENT INVOLVEMENT AT THAT POINT AND I'M GOING TO TALK ABOUT THE TOUCH POINTS TO HELP THE GOVERNMENT MAKE A MORE INFORMED AND BETTER SYSTEMATIC REVIEW, WHERE THE QUESTIONS AND THE ANSWERS COULD BE MORE APPROPRIATED AND TARGETED. SO THOSE ARE THE CONDITION THAT IS CDC AND ARC HAVE AGREED UPON, BASED ON DATA, AND WHERE THE MOST IMPACT CAN BE MADE. YOU CAN'T REALLY LOOKING AT UNIVERSE. HAVE YOU TO NARROW YOUR SCOPE N TERMS OF OF WHAT ARE THE CONDITIONS. CHRONIC PAIN IS DEFINED FOR THIS SYSTEMATIC REVIEW AS PAIN FOR GREATER THAN 12 WEEKS OR PAST NORMAL TISSUE HEALING TIME. THAT'S HOW IT'S BEING DEFINED. GREATER THAN 12 WEEKS SO THE INTERVENTIONS ARE LISTED THERE THAT ARE GOING TO BE LOOKED AT AND ESSENTIALLY, THE QUESTIONS WILL COMPARE ACROSS BOAST CONTROLS, WHICH ARE SHAM TREATMENTS, USUAL CARRY, AND NO TREATMENT, AND A NUMBER OF ACTIVE COMPARE TERES. NOUN INPHARMA COLOGICAL THERAPY. EXERCISE, THAT IS WHAT HAS BEEN STUDIED. EXERCISE AND ITS IMPACT ON PAIN. OTHERS CAN COME UP AS THEY GET INTO THE REVIEW AND DIG INTO WHAT MORE ARE. BUT THESE ARE THE PROPOSED ONES THEY ANTICIPATE. EVIDENCE-BASED PRACTICE CENTERS, SYSTEMATIC REVIEW PROCESS. FIRST, THERE'S A TOPIC. NON-PHARMACOLOGIC TREATMENT FOR PAIN. THESE TOPICS COME FROM MANY, JUST AS -- JUST SO JUROR AWARE, FROM MANY DIFFERENT SOURCES. THIS ONE WAS THROUGH THE CDC AND ASSBI AND ARC. BUT YOU ALL CAN MAKE NOMINATIONS FOR TOPICS. SO IF YOU HAVE PROFESSIONAL ORGANIZATIONS, SOCIETY IT IS, THE PUBLIC CAN NOMINATE TOPICS. IT'S ON THE WEBSITE, ANY TIME YOU'D LIKE TO NOMINATE A TOPIC. THAT WILL GET EVALUATED, IF IT'S ACCEPTED FOR A FULL SYSTEMATIC REVIEW LIKE THIS ONE IS, A POST OF THE DRAFT KEY QUESTIONS WILL BE OUT THERE FOR PUBLIC COMMENT AND I'LL PUT THOSE DATES UP FOR THE NEXT SLIDE. THIS IS WHERE YOU ALL CAN GET INVOLVED. YOUR TIMES, PRO DOCS, POST DOCS. YOUR SCIENCE TEAM CONSIST GET INVOLVED. WHENY WE POST THE KEY QUESTION NON-PHARMACOLOGIC REVIEW PROCESS, AND YOU THINK THEY WERE NOT RIGHT OR THEY COULD BE TWEAKED, THERE'S OPPORTUNITIES. AFTER THEY ARE FINALIZED, THE KEY QUESTIONS WILL THEN GO TO THE ANALYTIC PROCESS IN LOOKING AT WHAT IS THE PROTOCOL GOING TO LOOK LIKE? THERE'S TECHNICAL EXPERTS AT THAT POINT, WHICH SOME OF YOU MAY EVEN ASK TO DO. I DON'T KNOW. YOU HAVEN'T SEEN THAT LIST. SOME OF YOU MAY BE ON THE TECHNICAL EXPERT PANEL. TO INFORM THE PLAN AND THE PROTOCOL AND THEN A REVIEW IS CONDUCTED. THEN A DRAFT REPORT IS POSTED. AT THAT POINT, IT'S PUBLIC. OUR TIMES CAN LOOKING AT THAT DRAFT REPORT, SEND YOUR COMMENTS IN AND I CAN TELL YOU FOR SURE, EVERY SINGLE COMMENT THAT WE GET, GETS READ AND GETS ACTED ON. FINANCIALLY, AFTER YOU GET FEEDBACK, THERE'S A FINAL REPORT THAT GETS POSTED AND TRADITIONALLY, THERE'S A COPUBLICATION OF MANUSCRIPTS AND THE EVIDENCE-BASED PRACTICE REPORT. THAT'S SORT OF HOW FAR IT GOES. NOW, THE REASON IT'S INTERESTING TO YOU ALL IS THE TIME THAT IS WE NEED YOUR HELP AND THE HELP OF THIS COMMIT AND THE WORK GROUPS OR ANYONE ELSE WHO'S INTERESTED IN CHRONIC PAIN, IS THESE TYPES HERE. SO IN DECEMBER 26, 2016, THE KEY QUESTIONS WILL BE POST ON THE ARCHEWEBSITE IN THE EVIDENCE-BASED PRACTICE CENTERS. THEN THERE WILL BE A PERIOD OF TIME COLLECTION AND THEN THAT WILL INFORM AND ADJUST THE ANALYTIC PLAN AND QUESTIONS. THEN ONCE THE ANALYTIC PLAN IS PUT TOGETHER. THE EVIDENCE-BASED PRACTICE CENTERS DO THEIR THING. THEY DO THEIR SYSTEMATIC REVIEWS AND THEN DRAFT REPORT WILL BE POSTED IN SEPTEMBER. AGAIN, FOR YOU ALL AND YOUR SCIENCE TIMES, THE CLINICAL TIMES TO HAVE INPUT AND THEN THE FINAL REPORT. I COULD BE QUICK. I KNOW WE'RE BEHIND TIME. DOES THAT MAKE REASONABLE SENSE TO EVERYONE? IS THERE QUESTIONS BEFORE I MOVE ON. TO THE RELATED ACTIVITIES IN THIS IS A REALLY EXCITING REPORT. I CAN ACTUAL, AS SOMEONE WHO'S, YOU KNOW, IN GOVERNMENT SERVICE, THE -- ELIZABETH, WHO'S A MEDICAL OFFICER AT ARC IS REALLY EXCITED BY THE FACT THAT YOU'RE EXCITED. WE GET EXCITED WHEN THE PUBLIC'S EXCITED WHEN OUR REPORTS ARE BEING REVIEWED AND PEOPLE ARE REALLY LOOKING FORWARD TO THEM. SO THIS IS VERY EXCITING WORK FOR THOSE OF US IN GOVERNMENT TO, SEE, THERE'S INTEREST OUT THERE. THERE'S EXCITEMENT. THERE ARE INDIVIDUAL WHO IS WANT TO COMMENT AND PLEASE, BY ALL MEANS, COMMENT. YOU KNOW, THIS IS GREAT. YOU'RE ON TRACK. WE REALLY THINK, YOU KNOW, WE HAVE REASON TO BELIEVE YOU'RE OFF TRACK HERE AND WE REALLY THINK IF YOU MOVE IN THIS DIRECTION, YOU'LL GET IN X AND Y Y, ET CETERA. >> THIS IS A VERY THOROUGH PROCESS AND IT'S VERY EXCITING TO SEE WHAT YOU'VE DONE SO FAR. SO I'M ALREADY THINKING AHEAD BECAUSE WE'RE GOING TO HAVE QUESTIONS AND THINGS TO BE EXCITED ABOUT ONCE THE REPORT GETS PUBLISHED. SO I WAS THINKING, WE SHOULD ALLOW ABOUT A YEAR AND A HALF, TWO YEARS, BETWEEN WHEN WE ASK YOU TO START THINKING ABOUT SOMETHING AND WE GET REPORT OR IS THERE A WAY WE CAN WORK WITH YOU, KIND OF EXPEDITE THAT A LITTLE BIT A LITTLE. >> FROM THE TIME WHEN THE TOPIC IS NOMINATED TO WHEN YOU SEE THE FINAL REPORT? TAKES QUITE A WHILE, THERE'S WINDOWS, 60 TO 90 DAY WINDOWS. NOT FORCED, WHERE THERE'S OPPORTUNITIES FOR THE PUBLIC TO MAKE COMMENTS AND THEN THERE'S A REQUIREMENT, REALLY, TOO TAKE THESE COMMENTS SEARLY. TO SYNTHESIZE THESE COMMENTS AND ACT ON THOSE COMMENTS. THIS IS NOT A SLOW PROCESS. SO THE WAY THAT IT CAN BE EXPEDITED IS WHEN THE ANALYTICAL PLAN IS FINALIZED AND THE EPC MOVING FORWARD. THE NUMBER OF MEMBERS OF THE EVIDENCE PRACTICE SISTER THAT ARE EMPLOYED TO ACTUALLY DO THE REVIEW. BUT THAT AGAIN, IS LIMITED TO ALSO, BY THE EXTRACTION, IN TERMS OF ANALYZE HAPPENING THE META ANALYSIS AND THE EXTRACTION. THESE TAKE TIMES AS WELL. SO THERE ARE CERTAIN PART THAT IS CAN BE EXPEDITED, UNLESS WE COME UP WITH A NEW WAY OF KICKING THESE REVIEWS, THERE ARE CERTAIN PARTS THAT ARE JUST, YOU KNOW, THAT YOU HAVE TO DO THE WORK. HAVE YOU TO ROLL UP YOUR LEAVES AND YOU'VE GOT TO DO THE WORK AND IT TAKES TIME TO DO THAT WORK. [PLEASE STAND BY] MUSCULOSKELETAL PAIN CONDITION, OTHER THAN O.A., WITH HUGE COSTS. I'M CURIOUS, I'M PUTTING IT ON MY TERRY ACTUALLY HAT HERE AS WELL. I JUST WONDERED WHAT THE OPPORTUNITY IS TO ADD ANOTHER HIGHLY PREVALENT, COSTLY AND VERY IMPACTFUL CONDITION TO THE LIST. >> TO GET IT ON THIS LIST? >> YEAH. >> I THINK THAT WOULD BE A CHALLENGE BECAUSE OF THE AGREEMENTS THAT OF COURSE MADE WITH THE CDC AND ASBE. HOWEVER, THERE ARE OPPORTUNITIES, AS YOU KNOW, IN ORDER FOR THE SYSTEMATIC REVIEW TO TAKE PLACE, THEY ONLY LOOKING AT RCTING ITALLY, THEY'RE LOOKING AT RANDOMIZED CONTROL TRIALS. SO IF THERE ISN'T A LOT RESEARCH ON THE TOPIC THAT YOU ARE NOMINATING ANA, THAT WILL LEAD TO INVESTIGATORS -- DEPENDING ON WHERE THE SCIENCE IS AT. YOU MIGHT BE BEST TO TARGET, BECAUSE YOU KNOW THE SCIENCE, IF THERE ISN'T SUFFICIENT RCT'S OUT THERE TO WARRANT A SYSTEMATIC REVIEW, MAYBE YOU'RE TARGETING THE WRONG THING. MAYBE WHAT NEEDS TO BE TARGETED IS INVESTIGATOR-INITIATED AWARD SOCIOLOGY THAT MORE RESEARCH CAN BE CONDUCTED, NEAR FOR CITIZEN ATTIC RESTRESS TILE DO THE ANALYSIS. >> A QUESTION, THE 2014 ARC REVIEW OF OPIOID GIVEN LONG-TERM FOR CHRONIC PAIN, INTRODUCE AID THRESHOLD FOR INCLUSION THAT, STUDIES WOULD BE DEEMED INAT WAIT DURATION F THEY LASTED FOR A YEAR OR SHORTER. AND I WONDER WHETHER YOU INTEND TO CONTINUE THAT EXCLUSION OR GO BACK TO A MORE TRADITIONAL BEST AVAILABLE EVIDENCE APPROACH WHERE YOU LOOK AT THE STUDIES AS THEY ARE. BECAUSE I CAN ACTUAL, WE HAVE ACTUALLY LOOKED AT THE PROFILE FOR BEHAVIORAL INTERVENTIONS. HOW LONG DID THE STUDY LAST, VERSUS HOW MANY STUDIES WERE DONE OF THAT DURATION AND AS WITH DRUG THERAPIES VIRTUALLY, THE CLEAR MAJORITY ARE NO LONGER THAN A HUNDRED DAYS. CLEAR MAJOR. SO HAVE YOU GIVEN CONSIDERATION OF THE INCLUSION CRITERIA. THIS IS A VERY IMPORTANT DOWN STREAMIMENT PACT THAT RESULTED ON ZERO STUDIES, ACTUALLY BEING INCLUDED TO COMMENT UPON THE EFFICACY. >> I THANK YOU FOR THAT QUESTION IN POINT. THIS IS EXACTLY THE REASONS WHY ELIZABETH IS REALLY EXCITED ABOUT THIS STUFF BEING PRESENTED BECAUSE, AND I GAVE HER YOUR E-MAIL ADDRESS. IF YOU HAVE SPECIFIC QUESTIONS REGARDING TO WHAT THE INCLUSION AND EXCLUSION CRITERIA IS, I QUITE FRANKLY DON'T KNOW AT THIS POINT WHAT, INCLUSION AND EXCLUSION CRITERIA ARE. THIS IS UNDER, THIS IS JUST GETTING STARTED. SO ELIZABETH, SPECIFICALLY SAID SHE'S WELCOME AS ANOTHER FEDERAL SERVICE PERSON. CAN YOU E-MAIL HER DIRECTLY, WITH SPECIFIC QUESTIONS. SHE WAS GRACIOUS ENOUGH TO PUT HER NAME OUT THERE. SEFOR SPECIFIC QUESTIONS LIKE THAT ABOUT HOW TO REVIEW I RECOMMEND YOU CONTACT ELIZABETH DIRECTLY, ASK HER ABOUT WHAT THE INCLUSION CRITERIA ARE AND SHE CAN RESPOND TO YOU DIRECTLY, RATHER THAN GOING THROUGH ME. SHE'S GOING TO BE LEADING THIS REVIEW WHAT'S ALSO EXCITING AND WHAT WE HEARD THIS MORNING. ARC HAS ALSO BEEN CHARGED, LIKE MANY OF THE OTHER AGENCIES TO LOOKING AT INITIATIVES AROUND OPIOIDS AND OPIOID PRESCRIBING PRACTICES, ET CETERA AND WE ARE GOING TO WITHIN THE NEXT MONTH, HOT OFF THE PRESS, THERE WILL BE A TECHNICAL BRIEF, WHICH IS A SYSTEMATIC REVIEW, THAT IS REALLY NOT A COMPARING EVIDENCE, BUT IS A SURVEY OF THE FIELD. ON WHAT'S OUT THERE WHAT SOME OF THE BEST PRACTICES ARE. WHAT ARE SOME OF THE HEALTH SERVICE DELIVERY METHODS AROUND MEDICATION-ASSISTED TREATMENT MODELS OF CARE, FOR OPIOID USE DISORDERS. THAT TECHNICAL BRIEF WILL BE PUBLISHED WITHIN THE NEXT MONTH. IT'S READY TO ROLL AND THIS COULD INFORM MODELS OF CARE, AROUND MEDICATION-ASSISTED THERAPY. THE SECOND, WHICH IS ALSO PART OF THE INITIATIVE AROUND REDUCING INPRESCRIBING PRACTICES THAT ARE NOT CONSISTENT WITH GUIDELINE, ET CETERA, IS LOOKING ALOOK --AT WAYS TO INCREASE MEDICATION-ASSISTED THERAPY N RURAL PRIMARY CARE PRACTICES. VERY EXCITING TO US. TAKING IT OUT TO AREAS WHERE THERE'S NOT RESOURCES, THERE AREN'T COGNITIVE-BASED THERAPIES. THERE ARE INN AS MANY PROVIDERS WHO ARE ELIGIBLE TO PRESCRIBE MEDICATIONS AND HOW CAN THAT BE OVERCOME AND WHAT ARE SOME OF THE BARRIERS. WE FUNDED FOUR GRANT THAT IS LOOKING AT TWICE DEVELOP. RELATIONSHIPS AND MODEL OF CARE AROUND MEDICATION-ASSISTED THERAPY. THE OTHER THING THAT'S HOT OFF THE PRESS, AND I CAN TALK ABOUT IT NOW IS INTENT TO PUBLISH AN RO1 AND AN R-18. THAT WAS JUST RELEASED LAST WEEK. AND THERE WILL BE AN R-18 THAT WILL BE LOOKING AT WAYS TO DISSEMINATE P-CORE FINDINGS. NOW, THAT'S NOT SPECIFIC AS YOU KNOW, ARC IS NOT A SPECIFIC DISEASE-ORIENTED ORGANIZATION. WE LOOKING AT HEALTH SERVICES DELIVERY AND CLINICAL TOPICS THAT ARE BROAD. PAIN COULD BE ONE OF THEM. IN TERMS OF PLAYING FOR AN R-18 AND INVESTIGATED-INITIATIVE FUNDING AROUND IMPLEMENTATION OF EVIDENCE AROUND PAIN MANAGEMENT OR PAIN PREVENTION THAT COULD BE PART OF THAT R-18, IN TERMS OF DISSEMINATION AND IMPLEMENTATION. JUST THROW THAT OUT THERE AS ANOTHER OPPORTUNITY THAT WILL BE COMING DOWN THE PIKE. THAT'S ALL I HAVE, AND THAT'S THE ON TOOT TO TALK ABOUT SOME OF OUR WORK. QUESTIONS IN ALL RIGHT. GREAT. >> GREAT. THANKS SO MUCH. WE REALLY APPRECIATE T. I THINK THE REVIEW WILL BE INCREDIBLY HELPFUL. NOW WE'RE GOING TO TURN TO KATHY UNDERWOOD. THANK YOU FOR YOUR PATIENCE. WE ALMOST GOT YOU IN THERE EARLY. SHE'S GOING TO TALK ABOUT SOME NATIONAL STRATEGY TEAM SUPPORT. >> IT'S TOUGH WHEN YOU'RE BETWEEN AND YOU LUNCH. I THINK MOST OF YOU ARE FAMILIAR WITH THE AMERICAN PAIN SOCIETY, BUT WE CONSIDER OURSELVES THE PROFESSIONAL HOME FOR INVESTIGATORS INVOLVED IN ALL ASPECTS OF PAIN RESEARCH, INCLUDING BASIC, CLINICAL, ATTENTIONLATIONAL AND HEALTH SERVICES. WE ARE MULTI DISCIPLINARY AND OF COURSE IN EXISTENCE SINCE 1974 AND I FELT APPRECIATE THE OPPORTUNITY TO GIVE THIS REPORT. THIS IS ABOUT A COLLABORATION BETWEEN APS AND PFIZER'S INSPECT GRANTS FOR LEARNING AND CHANGE, TOO IMPROVE CHRONIC PAIN CARE. AND I WANT TO EMPHASIZE HERE, THAT USE OF THE WORD "INDEPENDT" IS IMPORTANT TO APS. MEANS THAT PFIZER HAS NO INFLUENCE OVER ANY ASPECT OF THE INITIATIVES, AND THEY ARE COUNTING ON APS FOR THE REPORTS AND RESULTS AND IMPACT OF THE FUNDED INITIATIVE. SO IT REALLY IS, ABOUT APS PFIZER APPROACHED APS AND TALKED ABOUT A COLLABORATIVE OPPORTUNITY TO FUND RESEARCH AND OUR DISCUSSIONS GOT US TO A POINT IN SEPTEMBER, WHERE WE WERE VERY SERIOUS ABOUT SIGNING A LETTER OF AGREEMENT WITH PFIZER TO FUND PAIN RESEARCH AND WE A POINT AID PANEL TO AUTHOR AN RPP. THE PANEL OF THE CLEAR ABOUT THE FACT THEY WANTED TO FOCUS ON THE NATIONAL PAIN STRATEGY BECAUSE WE WERE WAITING FOR IT TO COME OUT. THAT'S BEEN ELUDED TO A NUMBER OF TIMES. BUT WE FINALLY SIGNED OUR L.O.A. IN DECEMBER OF 2015 AND BEGAN WORKING IN JANUARY OF '16. THESE ARE THE PROFESSIONALS THAT ARE ON THE GRANT STEERING COMMIT AND HE THEY WERE INVOLVED IN THE WRITING THE RPF AND RELATING IT BACK TO THE NATIONAL PAIN STRATEGY. AS PART OF THE PROCESS, DEVELOPED A CALL FOR LETTERS OF INTENT. IT WAS A TWO-STEP PROCESS. LETTERS OF INTENT CAME FIRST AND THEN WE WENT ON TO THE RFP PROCESS AND THE EXCERPT FROM THE PRESS RELEASE WAS WE WERE AGAIN, FOCUSING ON THE NATIONAL PAIN STRATEGIC PLAN YEAR, WE WERE ABLE TO GET PFIZER TO COMMIT $2 MILLION TO THIS EFFORT AND SO WE SENT OUT OUR CALL FOR LETTERS OF INTENT AND RECEIVED CLOSE TO A HUNDRED OF THOSE. WHY THE NATIONAL PAIN STRATEGY? WELL, WE'VE BEEN A LONG TIME PROPONENT OF A NATIONAL LEVEL APPROACH TO PAIN MANAGEMEN WE HAVE HAD MANY PEOPLE FROM AP INVOLVED IN THE IOM AND NATIONAL PAIN STRATEGY DEVELOPMENT. AND WE BELIEVE THE NATIONAL PAIN STRATEGY SUPPORTS ACS VALUES OF THE MULTI DISCIPLINARY APPROACH TO PAIN CARE. WE HAVE ALSO IDENTIFIED IT AS A KEY STRATEGIC ISSUE FOR APS SO THE REQUESTS FOR LETTERS OF INTENT, LIKE I SAID, WE RECEIVED CLOSE TO A HUNDRED AND THEY WERE REVIEWED BY TWO PANEL MEMBERS EACH THROUGH ABOUT JULY AND THEN WE IDENTIFIED 15 PROPOSALS THAT WE FELT WERE GOOD ENOUGH TO YACHT QUALIFY FOR AN P.M. SO THEY WERE INVITED BACK TO PRESENT FULL PROPOSALS AND THOSE WERE DUE SEPTEMBER 12. THOSE PROPOSALS ARE CURRENTLY UNDER REVIEW BY ANNEX PANELEDDED GROUP OF PEOPLE AND THEY WILL EACH SCORE A THREE PROPOSALS EACH AND WE INTEND TO HAVE A FACE-TO-FACE MEETING, WHICH HAS BEEN SCHEDULED FOR NOVEMBER 9, WITH THE GOAL OF SIGNED LETTERS OF INTENT BY THE END OF THE YEAR. AFTER WE HAVE SUCCESSFUL PROPOSALS AND WE EXPECT THAT THE REQUESTS FOR MONEY WERE IN THE RANGE OF 200 TO 7 -- $200,000 TO $750,000 EACH. ONCE WE HAVE OUR FUNDED GRANTS, WE INTEND TO CONVENE A MEETING OF THE SUCCESSFUL GRANTEES TO TALK ABOUT THINGS THAT MAY OR MAY NOT BE COLLABORATIVE AMONG THEM. SO THAT THEY GET A SENSE OF EACH OTHER'S WORK AND THAT THERE'S REALLY A SENSE OF, LIKE I SAID, COLLABORATION TOWARDS THE GOAL. WE, APS, WILL BE OVERSEEING THEIR PROGRESS REPORTS AND REPORTING BACK TO PFIZER. WE HOPE TO PRESENT THE OUTCOMES, AT EITHER OUR 2018 OR 2019 ANNUAL SCIENTIFIC MEETING. THESE GRANTS WILL MOST LIKELY BE 18 MONTHS LONG THEN PUBLISH THE FINDINGS IN A PEER REVIEW JOURNAL. IT IS A LONG PROCESS, BUT WE WANTED TO MAKE YOU AWARE OF THE FANG THAT THIS IS SOME AIR, THAT APS IS TRYING TO CREDIBILITY TO THE IMPLEMENTATIO--SPS IS TRYING TO CONTRI BUTE TO THE NATIONAL PAIN STRATEGY. >> JUST A STRAIGHTFORWARD QUESTION. CAN YOU GIVE US A SENSE OF THE TYPE OF RESEARCH THAT YOU HAVE RECEIVED OR MIGHT EXPECT TO RECEIVER YOU ALREADY RECEIVED IT FROM THE 15TH? LOT OF IT IS POPULATION BASED RESEARCH. SOME OF IS IS MORE TECHNICAL IN TERMS OF STUDIES OF EFFECTIVENESS, OUTCOMES BUT THERE'S, UNTIL WE GET CLOSER TO THESE THREE, TWO OR THREE, AIDE HATE TO SAY ANYTHING MORE ABOUT IT -- I'D HATE TO SAY ANYTHING MORE ABOUT T ALLEN. THEY'VE BEEN ALL OVER THE MAP. I WAS SURPRISED AT HOW MANY PEOPLE RESPONDED TO THIS. WE WERE HOPEFUL THAT WE WOULD GET 50 LETTERS OF INTENT. AND GETTING CLOSE TORE A HUNDRED SHOWED US THAT THE NATIONAL PAIN STRATEGY IS REALLY VERY IMPORTANT. >> Linda Porter: ANYMORE QUESTIONS FOR KATHY? EVERYBODY READY TO EAT. WE HAVE AN HOUR FOR LURCH. SO WIELD LIKE TO HAVE EVERYBODY COME BACK AT 1:00. WE HAVE A PRETTY FULL AFTERNOON. SO I THINK WE NEED TO BE BACK AND SAYING THE TABLE AT 1:00. THERE'S A CAFETERIA DOWNSTAIRS IN THE A-BUILDING AND A LITTLE SNACK PLACE, IF YOU WANT TO BUY SOMETHING OR IF YOU HAVE BROUGHT SOMETHING WITH YOU, YOU'RE WELCOME TO BRING IT IN HERE. SO WE'LL SEE YOU IN AN HOUR. THANKS VERY MUCH, EVERYBODY. >> OKAY, SO I'M SURE WALTER WILL BE HERE IN A FEW MINUTES AND WE'RE--WE'LL GET STARTED. WE HAVE A TIGHT AGENDA THIS AFTERNOON BECAUSE WE HAVE ALL 5 CO-CHAIRS FROM THE WORKING GROUPS AND THE FEDSERAL PAIN RESEARCH STRATEGY ARE GOING TO CALL IN, MAKE BRIEF PRESENTATIONS AND THEN GIVE YOU ALL A LITTLE BIT OF TIME TO ASK THEM QUESTIONS ABOUT THEIR SPECIFIC EFFORTS. WHAT I WOULD LIKE TO TO DO BEFORE ALAN STARTS US OFF WITH THIS SECTION IS RECOGNIZE SOME OF THE PEOPLE IN THE BACKGROUND WHO YOU MAY NOT REALIZE HOW MUCH WORK THEY PUT IN. SO WE HAVE 4 SENIOR LEVEL ANALYST PARTLY IN OUR OFFICE AND ANOTHER PERSON FROM DENTAL RESEARCH INSTITUTE WHO'VE BEEN INCREDIBLY HELPFUL KEEPING THESE MOLTINGS GOING AND HELPING WITH PORTFOLIO ANALYSIS AND WE HAVE CAROL RAMOS, BACK THERE, YOLACIN, DA, HAS BEEN INCREDIBLY HELPFUL AND SHE HAS A COLLEAGUE PRISESY CHANDLER WHO IS HELPING WITH 1 OF THE WORK GROUPS AND THEN BEHIND ME, LEA AND SHERIE, AND THEY HAVE BEEN NONSTOP KEEPING THIS GOING, SO THANK YOU TO THEM. AND THEN ALAN, YOU ARE UP. >> HI. THANK YOU LINDA. SO I JUST THOUGHT I HAVE A BRIEF INTRODUCTION TO REMIND EVERYONE OF THE STRUCTURE OF THE WORKING GROUPS, HOW THIS WAS SET UP IN ORDER TO BUILD A FEDERAL PAIN RESEARCH STRATEGY. AND SO, A FEW OF THESE SLIDES ARE THE 1S YOU'VE SEEN PREVIOUSLY BUT IT'S JUST A REMINDER HOW THIS ALL CAME ABOUT. SO THE IPRCC, ESTABLISHED A STEERING COMMITTEE, THAT IS THE SLIGHTLY UNDER THE UBER COMMITTEE IS THE BEST WAY TO DESCRIBE IT. THESE ARE THE MEMBERS OF THE STEERING COMMITTEE AND THESE ARE THE GROUP TO WHOM THE SUBSEQUENT WORKING GROUPS REPORT AND I WILL NOT GO THROUGH NAMES. YOU RECOGNIZE NAMES BUT IT'S VERY BROAD AS CAN YOU SEE. THE STEERING COMMITTEE HAD TELEPHONE CALLS A LONG TIME AGO, NOW, WHERE WE DISCUSSED AND AND IDENTIFIED CO-CHAIRS FOR THE DIFFERENT WORKING GROUPS. THAT WAS THEIR INITIAL CHARGE AND THEY DID NOT PICK THE MEMBERS OF THE WORKING GROUP AND THAT'S AN IMPORTANT DISTINCTION. CO-CHAIRS IDENTIFIED NAMES WITH SUGGESTIONS FROM THE STEERING COMMITTEE. SO THE WORKING GROUPS WERE ESTABLISHED AND THE IDEA IS THAT THERE'S MEANT TO BE FEEDBACK AND YOU'LL SEE HOW THIS WORKS IN A SECOND BETWEEN THE WORKING GROUP PRODUCT, WORKING GROUP PRODUCT AND THE STEERING COMMITTEE AND THEN KEEP GOING BACK AND FORTH EVENTUALLY UNTIL WE COME UP WITH ULTIMATE PRIORITIES THAT WILL BE SENT UP TO THE IPRCC. AND WITHOUT FORGETTING, DON'T WANT TO FORGET THE SUPPORT FROM LINDA'S OFFICE AND I'M GLAD SHE MENTIONED THE PEOPLE WITH WHOM SHE WORKS BECAUSE THEY HAVE ABSOLUTELY ESSENTIAL IN PROVIDING INFORMATION, DATA AND ALSO A DIFFERENT TIMES BEING ON THE MANY TELEPHONE CALLS THAT THE WORKING GROUPS HAVE HAD AND SO, THEIR SUPPORT AS REALLY BEEN ESSENTIAL AS AN UNDER STATEMENT. IT'S BEEN TERRIFIC AND I WILL ECHO EVERYONE'S COMMENTS ABOUT LINDA. IT'S JUST BEEN--IT'S ACTUALLY BEEN I ALMOST WOULD SAY ENJOYABLE. [LAUGHTER] THAT'S PRETTY GOOD FOR CALIFORNIA. SO THERE ARE 5 WORKING GROUPS. AND YOU MAY OR MAY NOT REMEMBER THIS HERE AND THEY WERE GENERATE OFFICE OF DIVERSITY WHAT WE WERE TALKING ABOUT IS THE CONTINUUM OF PAIN. THE NOTION THAT PAIN CAN BEGIN VERY EARLY IN LIFE AND GO THROUGH LIFE AND THERE ARE 5 WORKING GROUPS FROM PREVENTION TO ACUTE PAIN, THE TRANSITION QUESTION FROM ACUTE TO CHRONIC PAIN, CHRONIC PAIN ITSELF, MANAGEMENT AND THEN AS YOU NOTICE IN AN OVAL, IT'S A SOMEWHAT A UNIQUE WORKING GROUP BUT AN ABSOLUTELY CRITICAL 1, DISPARITIES BECAUSE MANY OF THE ISSUES THEY'RE ADDRESSING CUT ACROSS ALL OF THE OTHER WORKING GROUPS. AND THE INTENT WAS TO DEFINE RESEARCH PRIORITIES THAT WILL BE ADDRESSED AND HOPEFULLY FUNDED IN THE FUTURE BY THE FEDERAL ALLEGESS WHO REPRESENTED AROUND THIS TABLE. AND YOU ALL KNOW WHO YOU ARE AND SO WE CERTAINLY HOPE THAT THE RESULTS OF THE PRODUCT OF THESE DELIBERATIONS WILL BE TAKEN BACK TO YOUR DECISION MAKERS AND THERE WILL BE FUNDING OVER THE YEARS. SO IT'S TO WHOM ARE WE ADDRESSING THIS PROBLEM. AND IN EVERY CASE, WE'RE DEALING WITH BASIC SCIENCE QUESTIONS AND CLINICAL ISSUES. AND TRANSLATION BETWEEN THE 2. MECHANISTIC QUESTIONS ARE OBVIOUSLY KEY TO THE RESEARCH PORTFOLIO. AND MANAGEMENT QUESTIONS. AND THE EMPHASIS AGAIN IS ON RESEARCH, BUT, I WOULD HIGHLIGHT THE FACT THAT THERE HAVE BEEN MANY INSTANCES IN WHICH THE REFERENCES HAVE BEEN MADE BACK TO THE NATIONAL PAIN STRATEGY AND I THINK AT SOME POINT IN THE FUTURE, TELL BE REALLY ESSENTIAL TO FIND WHERE THE 2 ACTUALLY CROSS. RIGHT NOW THEY'RE KIND OF RUN NOTHING 2 PARALLEL TRACKS BUT AT SOME POINT, IT WOULD--THEY WILL JUST HAVE TO INTERACT TO FIND OUT WHERE THE RESEARCH CAN INFLUENCE 1 AND WHERE THE CONCERNS OF 1 WILL INFLUENCE THE ULTIMATE RESEARCH QUESTIONS. SO THE WORKING GROUP CO-CHAIRS, I LIST THEM HERE, YOU WILL HEAR FROM SOME OF THEM TODAY WHO WILL PRESENT AN UPDATE, IS THE BEST WAY TO DESCRIBE IT, IT'S NOT A FINAL PRODUCT BY ANY MEANS OF THE DIFFERENT GROUPS AND I THOUGHT, IT'S ALWAYS NICE TO PUT NAMES TO FACES, SO HERE ARE THE NAMES AND HERE ARE THE FACES. SORT OF LIKE A TEST, HAVE YOU FOCUSED ON FIGURE OUT WHO'S WHO. I COULDN'T FIGURE OUT A WAY TO GET THE NAMES ON IT BUT YOU WILL MEET SOME OF THESE INDIVIDUAL WHO IS HAVE BEEN ABSOLUTELY SPECTACULAR. NOW THE PROCESS THAT WE HAVE FOLLOWED AND THIS IS REALLY MY LAST SLIDE. SHOWED THIS SLIDE TO YOU A LONG TIME AGO AND AT THAT TIME WE WERE REALLY WAY OVER ON THE LEFT SIDE OF THE SLIDE WHERE THE STEERING GROUP HAD IDENTIFIED OR SUGGEST CO-CHAIRS AND I'M REALLY PLEASED TO SAY THAT ALL BUT 1 INDIVIDUAL DIDN'T ACCEPT THE INVITATION TO BE A CO-CHAIR AND THAT'S BECAUSE THEY HAD A CONFLICT. SO THE PEOPLE REALLY STEPPED UP TO THE PLATE. SO THE CO CHAIRS THEN MADE SUGGESTIONS FOR ABOUT 10-12 INDIVIDUALS FOR THEIR COMMITTEES. THESE SUGGESTIONS WENT BACK TO THE STEERING COMMITTEE, THE STEERING COMMITTEE APPROVED THEM IN ALMOST EVERY INSTANCE AND THEN THE THE WORK BEGAN AND WHAT THE WORK CONSISTED OF IS LARGELY WEEKLY OR BI-WEEKLY TELL PHONE CALLS, CONFERENCE CALLS OF AN HOUR, USUALLY EACH CALL FOR EACH COMMITTEE. EITHER LINDA OR I OR BOTH OR SOMEONE FROM HER OFFICE HAVE ALWAYS BEEN ON ON 1 OF THE CALLS. SO WE TRY TO BE ON THEM. AND I THINK I'VE BEEN ON QUITE A FEW AND I ENJOYED THE DISCUSSIONS AND IT'S BEEN A VERY EVOLVING PROCESS AND YOU WILL HEAR FROM 1 REPRESENTATIVE OF EACH WORKING GROUP AS TO WHERE THEY ARE AND WHERE THEY'RE GOING. AS PART OF THE DELIBERATIONS AND DISCUSSIONS, THERE WAS AN ANALYSIS OF PORTFOLIO ANALYSIS, WITH INFORMATION, WHERE IS THE MONEY GOING RIGHT NOW AND 1 OF THE EMPHASIS THAT WAS MADE WAS THAT YOU WANT TO LOOK TO THE FUTURE FOR RESEARCH BUT THAT DOESN'T MEAN YOU DON'T WANT TO STILL ENCOURAGE SOME OF THE RESEARCH THAT'S STILL ONGOING, THERE WAS SOME CONCERN, OH WE ONLY WANT THINGS THAT ARE BEING DONE, NO, THERE'S GOOD SCIENCE GOING ON AND YOU DON'T WANT TO SAY WELL, LET'S STOP THAT. THERE WAS LITERATURE REVIEW. WHAT IS OUT THERE. SEVERAL OF THE WORKING GROUPS THEY IDENTIFIED MAYBE A HALF A DOZEN TO A DOZEN NAMES OF PEOPLE FROM OUTSIDE THEIR GROUP AND THEY SENT A SMALL SURVEY, 3 OR 4 QUESTIONS AND THE FEEDBACK WAS PRETTY IMPRESSIVE SAYING, LOOK, WHAT DO YOU SEE AS A MAJOR RESEARCH PRIORITY FOR THE FIRST 5, 10 YEARS OR WHATEVER AND THAT INFORMATION WAS INCORPORATED. IN ADDITION 3 OF THE 5 GROUPS HAD A FACE-TO-FACE MEETING, 2 AT THE CHICAGO AIRPORT, 1 AT THE WASHINGTON AIRPORT AND THAT JUST GIVES YOU A SENSE OF THE COMMITMENT OF THESE PEOPLE TO FLY IN, SPEND A FULL DAY AT A LOVELY AIRPORT HOTEL BUT THOSE TURNED OUT IN SOME CASES, WOW, WE DON'T NEED 5 FACE-TO-FACE, I WOULD SAY THEY WERE AMONG THE MOST USEFUL USE OFFUL INTERACTIONS BUT THERE WERE SOME ON TELEPHONE CALL WHO IS DON'T SPEAK UP, SOME ARE MORE SHY THAN OTHERS AND IT'S AMAZING, PUT THEM IN THE ROOM AND THE SHYNESS DISAPPEARS. SO THERE WAS A LOT MORE INTERACTION AND PEDE BACK AND IT WAS REALLY HELPFUL. SO THAT'S WHERE WE ARE NOW. MOST OF THE GROUPS HAVE IDENTIFIED AND ARE CLOSE TO IDENTIFYING PRIORITIES, THEY'RE NOT THERE YET. ONE OF THE BIG ISSUE SYSTEM HOW MANY PRIORITIES SHOULD THEY BRING TO THE NEXT STAGE WHICH I'LL TELL BUT IN A SECOND. AND THAT'S A DISCUSSION THAT THERE'S NO REAL ANSWER. IT'S A DECISION THEY'LL HAVE TO MAKE. THAT I HAVE TAKE KNOW A DIFFERENT PATH IN SOME CASES AND YOU WILL SEE THAT, SO THE NATURE OF THE PRESENTATIONS YOU WILL HEAR ABOUT WILL NOT BE IDENTICAL. THEY'RE A WORK IN PROGRESS. I EMPHASIZE THIS. YOU WON'T SEE A LIST OF HERE'S THE PRIORITIES, WE'RE MOVING FORWARD. MOST CASES YOU WILL HEAR ABOUT THE PROCESS AND QUESTIONS, BUT YOU'LL GET A SENSE OF EFFORT THAT WENT INTO THIS GROUP AND I'LL END IT BY SAYING THIS IS WHERE WE ARE NOW. SO MANY OF GAPS, DISCOVERIES, ARE AND THE PURPLE LINE ARE THE NEXT STEPS ANDS NEXT STEPS AFTER THE INDIVIDUAL GROUPS ESTABLISH THEIR OWN PRIORITIES, THEN THE CO-CHAIRS WILL TAKE THOSE AND THEY WILL MEET EITHEROT TELEPHONE OR PERHAPS EACH FACE-TO-FACE TO THEN THROUGH SOME DELPHI PROCESS COME UP WITH A LIST OF PRIORITIES AND THE ACTUAL NUMBER IS NOT CLEAR. IN THE CASE OF PAIN IT'S A COMPLICATED 1 WITH THE BREDTH OF ISSUES IS SO EXTENSIVE SO THAT'S THE NEXT STEP. THOSE PRIORITIES WILL THEN GO TO THE STEERING COMMITTEE WHOLE GO THROUGH THEIR PROCESS, GO BACK TO THE CO-CHAIRS, EVENTUALLY IT WILL FILTER UP TO THE IPRCC TO THIS TABLE. IT SAYS DECEMBER 2016, THAT'S PROBABLY A LITTLE OPTIMISTIC BUT I THINK WE'RE CLOSER THAN WE THOUGHT WE MIGHT BE IF YOU ASKED US 3 OR 4 MONTHS AGO, SO THAT'S WHERE WE ARE AND I THINK IF WE HEAR FROM THE--FROM THE DIFFERENT GROUPS, YOU WILL GET A SENSE OF THE PROGRESS THAT'S BEEN MADE. >> I THINK ALSO, IT'S GOOD TIMING BECAUSE, WITH THE IN-PROCESS SO THE FOLKS AROUND THE TABLE CAN HAVE INPUT AS OPPOSE TO THINK THING WHEN IS THEY'RE ALL DONE. SO THIS IS--AS AL SAID IT'S A WORK IN PROGRESS BUT NOW IT'S FLEXIBILITY ENOUGH WE CAN GET INPUT IN. >> THAT'S RIGHT MPLET I DID OMIT 1 POINT THAT LINDA JUST REMINDED ME, THE INITIAL PROGRESS REPORTS DID GO BACK TO THE STEERING COMMITTEE AND WE A LONG CONVERSATION AT WHICH POINT THE STEERING COMMITTEE WEIGHED IN AND SAID, WELL, GHEE, WHAT ABOUT SUCH AND SUCH AND AND 1 OF THE MOST INTERESTING DISCUSSIONS THAT WENT BACK TO THE WORKING GROUPS IS, TO WHAT EXTENT--OT 1 HAND A LOT OF THE RESEARCH MIGHT SOUND DERIVATIVE, THAT IT'S BUILDING UPON WHAT'S BEING DEN AND THAT'S A REALLY PEJORATIVE TERM IN THE BASIC SCIENCE WORLD, CERTAINLY, AND AS OPPOSE TO REALLY BIG BENEFIT, MAYBE HIGH RISK, AT WHAT POINT DO WE GO FOR THE GOLD WHERE YOU DON'T REALLY KNOW WHAT'S GOING TO HAPPEN AND YOU MIGHT EVEN FAIL BUT THAT'S WHAT YOU'RE LOOKING FOR AND I THINK THERE WAS A SENSEOT PART OF SOME OF THE MEMBERS OF THE COMMITTEE. THEY WANTED TO SEE THAT. AND THAT WENT BACK TO THE--OF THE STEERING COMMITTEE AND THAT WENT BACK TO THE WORKING GROUPS AND WE'LL SEE HOW THEY HANDLE THAT. >> SO ROGER WE HAVE YOU FIRST ON THE LIST FOR YOUR PRESENTATION FROM DISPARITIES. >> OKAY. >> OKAY, GREAT. WELL ALAN THANKS FOR THAT INTRODUCTION AND I WILL UPDATE YOU ON OUR DISPARITIES WORKING GROUP ACTIVITIES I BELIEVE ON THE PHONE WE HAVE CHERYL STUCKY, MY CO-CHAIR ARE YOU THERE, CHERYL? >> GREAT. >> HELLO. >> GREAT. >> HELLO, EVERYBODY. >> GREAT. AND WE'VE JUST HAD A REALLY OUTSTANDING WORKING GROUP. THESE AREN'T ALL THE MEMBERS PRESENTED HERE. WE BROKE OUR WORKING GROUP DOWN INTO 5 DIFFERENT SUBGROUPS TO ADDRESS THE PRIMARY DISPARITY ISSUES AND POPULATIONS WE FELT WERE HIGHEST PRIORITY. AND SO, YOU SEE THE CHAIRS OF THOSE SUBGROUPS THERE AND THEN WE WOULD ALL COME BACK TO TOGETHER, SO THESE INDIVIDUAL SUBGROUP HIS THEIR OWN CONFERENCE CALLS AND THEN WE CAME BACK TOGETHER EVERY COUPLE OF WEEKS IN AN OVERALL CONFERENCE CALL TO RECONCILE ISSUES AND PUT THINGS TOGETHER AND SO I'M JUST GOING TO QUICKLY RUN THROUGH OUR CURRENT LIST OF PRIORITIES. AS ALAN MENTIONED THIS IS A WORK IN PROGRESS AND YOU'LL SEE THAT OUR PRIORITIES BY AND LARGE ARE CROSS CUTTING ACROSSLET ENTIRE DISPARITIES DOMAIN AS OPPOSE TO SPECIFIC TO 1 OR MORE GROUPS OF OUR--OF OUR PURVIEW HERE. SO IF WE JUST START WITH THE FIRST--WE BELIEVE IT'S IMPORTANT BETTER TO DEFEIGN THE EMEPIDEMIOLOGY OF PAIN AND DIFFERENT POPULATIONS. WHILE WE CERTAINLY KNOW A LOT ABOUT THE EPIDEMIOLOGY OF PAIN, WE HAVE SUBSTANTIAL GAPS IN UNDERSTANDING THE EPIDEMIOLOGY OF PAIN. AND CERTAINLY GROUPS WHEN YOU CROSS POPULATION GROUPS OF KIDS OF DIFFERENT ETHNIC GROUPS AND DIFFERENT GENDERS AND SO ON AND SO FORTH, THERE ARE PLENTY OF GAPS THERE. WE ALSO THINK IT'S IMPORTANT TO CONDUCT RESEARCH TO DETERMINE OPTIMAL METHODS TO ASSESS AND TREAT PAIN IN DIFFERENT POPULATION GROUPS. CERTAINLY, IN CHILDREN AND OLDER ADULTS, AND THE COGNITIVELY IMPAIRED. UNDERSTANDING HOW BEST TO ASSESS PAIN IS IMPORTANT. AND WE REALLY DON'T KNOW VERY MUCH AT ALL ABOUT HOW BEST TO TREAT PAIN IN DIFFERENT POPULATION GROUPS AND IT MAY BE THAT THE SAME PAIN TREATMENTS ARE EFFECTIVE FOR ALL POPULATION GROUPS ALTHOUGH I SINCERELY DOUBT IT BUT WE JUST DON'T HAVE THE DATA. ANOTHER GAP WE'VE DISCUSSED IS THE IMPORTANCE OF INVESTIGATE BIOLOGICAL, PSYCHOLOGICAL AND SOCIAL MECHANISMS UNDERLYING THE DEVELOPMENT AND PERSISTENCE OF PAIN IN DIFFERENT POPULATION GROUPS ACROSS THE LIFE SPAN. RECOGNIZING THAT SOME OF THESE MECHANISMS MIGHT BE CONSISTENT ACROSS MULTIPLE POPULATION GROUPS, SOME OF THE MECHANISMS MIGHT BE SPECIFIC TO POPULATION GROUPS AND THOSE ARE THE KIND OF DATA THAT WE NEED IN ORDER TO MOVE FORWARD. BUT BETTER MECHANISM BASED THERAPIES. >> ANOTHER PRIORITY WE HAVE IDENTIFIED IS TO IDENTIFY SPECIFIC DEVELOPMENTAL PERIODS AND LIFE STAGES THAT ARE ASSOCIATED WITH DIFFERENTIAL RISK FOR PAIN CONDITIONS AND TO UNDERSTAND THE MECHANISMS RESPONSIBLE FOR THOSE LIFE SPAN INFLUENCES. AND WE REALLY DON'T KNOW A LOT ABOUT HOW DIFFERENT LIFE STAGES ALTER RISK FOR PAIN OR ALTER PAIN EXPERIENCES. MOVING ON AND THESE REMAIN THESE SORT OF CROSS CUTTING GAPS WE THINK IT'S IMPORTANT TO CHARACTERIZE WITHIN THE GROUPS OF DIFFERENT VARIABILITY AND PAIN AND POPULATION GROUPS, WE'RE ALL ACCUSTOMED TO TALKS ABOUT DIFFERENCES BETWEEN POPULATION GROUPS, RIGHT? WHO'S GOT MORE PAIN. THIS GROUP? THAT GROUP AND THAT'S ALL FINE AND GOOD AND IT MIGHT BE IMPORTANT. WHAT'S MORE IMPORTANT IS WHAT IS DRIVING PAIN WITHIN SPECIFIC POPULATION GROUPS AND THAT MIGHT VARY. AND SO UNDERSTANDING WITHIN GROUP VARIABILITY AND THE SOURCES OF THAT WITHIN GROUP VARIABILITY WILL BE PARTICULARLY IMPORTANT. WE ALSO RECOGNIZE THE IMPORTANCE OF EVALUATING THE IMPACT AND LONG-TERM CONSEQUENCES OF FARM OICOLOGICAL AND PSYCHOSOCIAL INTERVENTIONS ACROSS THE LIFE SPAN. THIS STARTED BY JUST FOCUSING ON PHARMACOLOGICAL INTERVENTIONS BUT THEN WE RECOGNIZE THAT MANY OTHER TYPES OF INTERVENTIONS INCLUDING PSYCHOSOCIAL INTERVENTIONS CAN IMPACT THE NERVOUS SYSTEM AND SO WE NEED TO UNDERSTAND THE LONG-TERM CONSEQUENCES OF MULTIPLE TYPES OF PAIN INTERVENTIONS ACROSS THE LIFE SPAN. WE ALSO FEEL IT'S IMPORTANT TO LOOK AT THE INFLUENCE OF BOTH SENSORY AND AFFECTIVE DIMENSIONS OF PAINOT PAIN EXPERIENCE GIVEN THAT THEY ARE POTENTIALLY DIFFERENTIALLY MODULATED SO WE NEED TO UNDERSTAND THESE DIMENSIONS OF PAIN AND FUNCTIONAL OUTCOMES IN DIFFERENT POPULATION GROUPS. AND AGAIN, THERE'S JUST NOT BEEN MUCH WORK WITH THIS POPULATION OR WITHIN POPULATION GROUPS TO DATE. AND SO THOSE ARE THE PRIMARY CROSS CUTTING THEMES. THERE ARE A COUPLE OF THEMES THAT ARE SPECIFIC TO 1 DISPARITY AREA OR ANOTHER THAT WE'VE DISCUSSED. ONE IS A VARIANT OF THE SORT OF WITHIN GROUP VARIABILITY ISSUE AND THAT IS PARTICULARLY FOR SEX DIFFERENCES, WE REALLY NEED TO UNDERSTAND QUALITATIVE SEX DIFFERENCES. THAT IS SEX SPECIFIC PAIN MECHANISMS, RECENT DATA OUTAGE AT JEFF MOGUL'S LAB WITH NEUROIMMUNE MECHANISMS ARE JUST THE LATEST EXAMPLE AMONG MANY EXAMPLES WHERE A GIVEN PAIN INFLUENCING MECHANISM OPERATES DIFFERENTLY IN MALE VERSUS FEMALES, ANIMALS OR HUMANS, OKAY? AND THAT HAS TREMENDOUS IMPLICATIONS FOR TREATMENT OF PAIN. SO THAT IS 1 OF THE PRIORITIES WE THINK IS IMPORTANT AND THEN FINALLY, WE THINK IT'S CRITICALLY IMPORTANT TO UNDERSTAND THE RELATIONSHIP BETWEEN SOCIOECONOMIC STATUS AND PAIN. THIS IS HORRIBLY UNDER STUDIED AND WE NEED TO UNDERSTAND THE MECHANISMS WHEREBY SOCIOECONOMIC STATUS CAN INFLUENCE PAIN AND THERE ARE MULTIPLE SOCIAL PSYCHOLOGICAL AND BIOLOGICAL MECHANISMS THAT CAN BE IMPORTANT HERE. PART OF THIS PRIORITY WOULD ALSO INCLUDE UNDERSTANDING HOW SOCIOECONOMIC STATUS MAY CONTRIBUTE TO ETHNIC GROUP DIFFERENCES IN PAIN BUT SOCIOECONOMIC STATUS ALONE IS IMPORTANT TO UNDERSTAND AT THIS POINT AS WELL. AND THAT'S AN UPDATE ON WHERE WE ARE WITH OUR PRIORITIES. CHERYL AND I--CHERYL WILL BE HAPPY TO ANSWER ANY OF YOUR QUESTIONS. [LAUGHTER] >> RIGHT. >> WE LEFT A LITTLE TIME IN EACH OF THESE SESSIONS FOR QUESTIONS. SO IF YOU HAVE A QUESTION FOR CHERYL AND ROGER. AND CHERYL AND ROGER WILL HIGHLIGHT THE TEAMS WHERE THERE'S A MORE BASIC OR CLINICAL ORIENTATION. >> THANK YOU BOTH--[INAUDIBLE DUE TO AUDIO FROM MIC GOING OUT ] >> SURE, SURE. YES, YES. SO 1 OF THE MECHANISMS IF YOU WERE WHEREBY S. E. S. CAN INFLUENCE PAIN IS BY IMPACTING ACCESS TO CARE, AVAILABILITY OF CARE, AND THAT CAN INCLUDE INSURANCE COVERAGE, BUT, EVEN WHEN INSURANCE IS EQUAL, ACCESS TO CARE MAY NOT BE EQUAL SO THERE ARE A VARIETY OF COMPLEX COMPONENTS THAT CAN CONTRIBUTE TO THIS, BUT YES, THAT WOULD BE PART OF WHAT WE WANT TO UNDERSTAND MORE ABOUT S. E. S. YES, YES. >> I SHOULD POINT OUT 1 THING TO THE COMMITTEE. THERE IS A PIECE OF PAPER IN YOUR FILE FROM THE ACUTE PAIN GROUP AND IT'S IN THE ILLUSTRATION OF HOW SOME OF THE FINAL PRODUCT MAY APPEAR AND THIS HAPPENED TO BE THE STAGE THAT THE ACUTE PAIN GROUP HAD AND A BASIC SCIENCE COMPONENT OF THE ACUTE PAIN GROUP HAD FORMULATED THEIR PRIORITIES WITH THE LITTLE PHOTOGRAPH DESCRIBING EVERYTHING, THE STEERING COMMITTEE JUMPED ON THIS, THEY LIKE TODAY AND WE PUT IT BACK TO THE DIFFERENT WORKERS AND ASKED THEM TO WORK FROM THAT WHICH HAD FRAMEWORK AND I EXPECT THAT THE NEXT TIME YOU SEE THIS, THAT'S WHAT IT'S GOING TO LOOK LIKE. >> YEAH, YOU ALSO HAVE THE MEMBERS LISTED. >> SO HOW DO YOU SEE YOURSELF--SO THERE'S 9 HERE. THIS IS A BIG QUESTION. I'M CURIOUS TO KNOW WHAT THE IPRCC MEMBERS THINK. IF EVERYONE WERE TO BRING 9 TO THE MEETINGS OF THE CO CHAIRS THAT WOULD BE, IF MY MATH IS CORRECT, THAT WOULD BE 45. WHICH IS A LOT. IT WAS NOT CLEAR, NEVER CLEAR TO ME AT THE BEGINNING AS TO WHAT IS A REASONABLE NUMBER OF THE FINAL PRODUCT AND THE REAL QUESTION IS, HOW IS THIS GROUP EVER GOING TO BE ABLE TO COME UP WITH A REASONABLE NUMBER THAT IS WORTH TAKING TO THE IPRCC AND I DON'T KNOW THE ANSWER TO THAT. HAVE YOU TALKED ABOUT THAT? >> YEAH, SO WE ALSO DON'T HAVE A NUMBER IN MIND. WE HAVEN'T BEEN GIVEN GUIDANCE IT THAT DIRECTION, MY BIAS WOULD BE TO BRING MORE RATHER THAN LESS AND LET SOMEBODY ELSE CUT THEM SO THAT WE'RE NOT THE TO BLAME FOR OMITTING SOMETHING DIFFERENT. [LAUGHTER] NOW WE HAVE TALKED ABOUT COMING TO CONSENSUS AND THAT'S WHERE WE ARE ON THESE 9 PRIORITIES BUT WE COULD ALSO DO A RANKING OR SORT OF A PRIORITY OF THESE PRIORITIES AND PUT THOSE FORWARD WHEN WE SUBMIT THE DOCUMENT AND SAY, THESE ARE OUR TOP PRIORITY IT IS, THESE ARE OUR INTERMEDIATE PRIORITIES, SO ON AND SO FORTH AND THEN I ENVISION THAT THERE'S GOING TO BE SOME OVERLAP BETWEEN SOME OF THE THINGS WE'RE PUTTING FORWARD AND WHAT SOME OTHER GROUPS MIGHT PUT FORWARD. SO THE MATH GETS A LITTLE EASIER IF THAT'S THE CASE. >> YEAH, JUST FOR THE RECORD TO FOLLOW UP ON THAT, THE FACT THAT THERE WILL BE OVERLAP IS RECOGNIZED AND THERE HAVE ALREADY BEEN DISCUSSIONS AMONGST--BETWEEN CO CHAIRS AND DIFFERENT WORKING GROUPS TO ADDRESS THE OVERLAP BEFORE THEY GET TO A FINAL MEETING SO THEY RECOGNIZE THAT, ABSOLUTELY. >> I GUESS MAYBE ASK THE OTHER I.T. DIRECTORS AS WE ENGAGE IN THESE TYPE OF PROCESSES FREQUENTLY AND FOR THEIR RECOMMENDATIONS HERE. SO, I MEAN FROM IN, INDS STABBED POINT, I THINK WHAT WE LEARN WAS IF YOU DON'T ASK FOR A SPECIFIC SHALL NUMBER, YOU GET A LONG LIST AND IT'S NOT THAT HELPFUL WHEN IT COMES AROUND TO MAKING DECISIONS. SO, WHETHER IT'S FAIR OR NOT, WE TEND TO WANT TO PUSH PEOPLE TO GIVE THE TOP 3 OR SOMETHING LIKE THAT. AND SURPRISINGLY PEOPLE IN GROUPS TEND TO BE ABLE TO DO THAT AND I THINK THAT'S HELPFUL THEN TO THE FUNDERS. THE 1 CAVEAT IS THAT PEOPLE CHEAT AND WHAT THEY TEND TO DO IS TO--THEY GIVE YOU 12 BUT THEY ACTUALLY HAVE POINT THEY POINT TO SO THEN THEY ACTUALLY HAVE 12. SO I DON'T KNOW WHAT THE OTHER DIRECTORS WOULD SAY ABOUT THIS. >> WE USED THE SAME TYPE OF APPROACH YOU DID WALTER AND WE THOUGHT THE LARGER THE LIST, THE LEAST IMPORTANT EACH 1 OF THE ITEMS WAS SO FROM A RESOURCE POINT OF VIEW, TIME AND ET CETERA. SO WE LOOKED AT THE LIST TO SEE IF THERE WAS SOME REDUNDANCY OR OVERLAP AND OFTEN FOUND SOME ITEMS COULD BE COMBINED SO WE ENDED UP, YOU KNOW TRYING TO HAVE A REASONABLE NUMBER OF 3-4, SOMETHING LIKE THAT. AND THE IMPORTANT AREAS. >> SO THERE IS A PLAN BUILT INTO THIS WHEN ALL THE DIFFERENT GROUPS HAVE THEIR PRIORITIES SET UP, AND WE HAVEN'T GIVEN THEM A SPECIFIC NUMBER YET THAT THERE WILL BE A DELPHI PROCESS WHERE ALL THE GROUPS WILL LOOK AT THE ENTIRE SET AND VOTE SOME OF THEM OFF THE ISLAND. SO THERE WILL BE A PROCESS OF NARROWING THEM DOWN, BUT WE DON'T HAVE A FINAL LIKE WHAT'S THE BEST NUMBER. SO FOR THE STROKE STRATEGY THERE WERE LIKE A HALF A DOZEN AND WE TALKED ABOUT THAT PAIN IS MUCH MORE COMPLEX IN MANY WAYS AND SHOULD THAT BE A BIGGER NUMBER SO YOUR INPUT WOULD BE REALLY HELPFUL. THANK YOU ROGER BY THE WAY. >> I HAVE A QUESTION FOR ROGER AND FOR THE COMMITTEE. SO THE AREEC NITION THAT THERE HAS%-œRESULTED INPAINORATLEAST%-œHA LF THE DAY AND PAST6 MONTHS,%-œANDWE WI LL APPROACHITINTERMS%-œOF DEFININGTHE C ONDITIONSWITH%-œHIGH PREVALENCE ANDACUTE %-œ[INDISCERNIBLE].%-œANDT HENOFCOURS THE SECOND 1 NOW. SO WE HAVE 5 DIFFERENT SUBGROUPS AS THE FIRST 1 IS REALLY THE START OF THE MEAT OF OUR WORKING GROUP AND THAT IS PREVENTION OF ONSET OF PAIN, THAT IS WHAT YOU CAN DO TO PREVENT OR REDUCE THE SEVERITY AND IMPACT OF ANTICIPATED SITUATIONS. SO FOR EXAMPLE, IF YOU ARE GOING TO HAVE SURGERY OR A PROCEDURE DONE WHEN AIM CANNOT BE COMPLETELY ELIMINATED WHAT CAN WE DO TO REDUCE THAT PANE AND THE ANTICIPATORY ANXIETY AND STRESS THAT'S ASSOCIATE WIDE IT. SO THINGS LIKE BETTER SELF-MANAGEMENT TECHNIQUES, PRIMARY PREVENTION OF COMMON PAIN SYNDROMES AND AS MOST OF YOU PROBABLY KNOW THE NUMBER 1 TYPE OF--YOU KNOW CHRONIC PAIN IS THE NUMBER 1 ILLNESS THAT IT OUTPACES HEART DISEASE, DIABETES, AND WHAT NOT AND OF CHRONIC PAIN LOW BACK PAIN, MUSK LO SKELETAL PAIN, AND TMJ, ARE NUMBER 2 AND THEN OF COURSE IS HEADACHES. SO WE WILL BASICALLY, WE'RE GATHERING INFOATION ON THAT. WE IS A LOT OF PEOPLE ON THAT PANEL THAT HAVE EXPERTISE. AND THEN, CONCURRENTLY, PREDICTING WHO IS AT RISK FOR ADDICTION OR MEDICATION MISUSE WHEN THEY'RE BEING TREATED FOR AT THE PRIMARY CARE LEVEL WHEN THEY'RE FIRST BEING TREATED AND EITHER OPIOIDS OR SOME OTHER POTENTIALLY ABUSIVE MEDICATION. SO WE'RE PRETTY WELL WITH THAT. AND THERE'S A LOT OF RESEARCH OUT THERE THAT WE'RE NOW PUTTING TOGETHER BUT WE WANT TO COME UP WITH PREVALENCE RATES AND SO ON. THEN NEXT WILL BE PAST ACUTE PHASE AND THEY'LL USUALLY--ANY TYPE OF ACUTE PAIN RESOLVES IN 6 WEEKS OR LESS, SOME FASTER, BUT THEN IT WILL---IF IT'S NOT RESOLVED THEN YOU START GETTING MORE RECURRENT, MORE PERSISTENT PAIN AND TONY TOLEDO'S THE CHEER OF THIS WORKING GROUP. SO THAT WHOLE START TO LOCK AT EARLY INTERVENTIONS FOR POST TRAUMA, TO BETTER FACILITATE RECOVERY TO NEGATIVELY REDUCE THE IMPACT OF IT. SO THINGS LIKE AVOIDING E. R. VISITS, THE MANAGED PAIN AFTER YOU MIGHT ADD AN INJURY TREATED AND THEN SPECIALIZED CLIPICAL AREAS OF COURSE ORTHOPEDICS AND THOSE ARE MAJOR CLOCK AREAS. THESE ARE THE IMPORTANT 1S, THAT IS THE WHOLE CATEGORY OF THE TRANSITION FROM ACUTE TO CHRONIC PAIN. A LOT OF PEOPLE WHEN YOU TALK TO THEM, THEY SAY OH WELL IT GOES FROM ACUTE TO CHRONIC. AND A LOT OF US ON THE COMMITTEE WITH EXPERIENCE WITH THAT TRANSITION PHASE, IT'S NOT THAT LINEAR. THERE'S A LOT OF DIFFERENT TRAJECTORIES, SOME HAVE ACUTE LEVEL PAIN FOR LONGER THAN OTHERS, SOME THEN GO INTO INTERMITTENT RECURRENT PAIN WHICH THEN CEASES AFTER 6 MONTHS. SOME IT DOESN'T CEASE. THEY HAVE A WEEK WHERE IT'S HIGH OR DISABLES, OTHER WEEKS WHERE IT'S NOT. AND IT'S HIGH AND LOW AND THEN IT COMES BACK. AND OTHERS ALSO EXPERIENCE CHRONIC PAIN AS WELL AS DISABILITY. SO I WOULD LIKE TO WORK WITH THE--I THINK I SPOKE WITH TED PRICE AND THAT 1 AREA OF THE TRANSITION WORK THAT WE POINTED OUT IS REALLY NOT ANY GOOD EPIDEMIOLOGICAL WORK ON IT AND PEOPLE JUST ASSUME, YOU KNOW, WE KNOW THAT TRANSITION, BUT WE--WE REALLY DON'T. SO YOU KNOW 1 THING THAT OUR GROUP'S GOING TO RECOMMEND IS A LONGITUDINA STUDY, STARTING FROM A PERSON WITH FIRST EPISODE OF SAY, LOW BACK PAIN. AND THEN FOLLOW THAT PERSON OVERTHE NEXT YEAR OR THAT GROUP OVER THE NEXT YEAR. WE KNOW FROM STATISTICS THAT IN TERMS OF LOW BACK PAIN, 80% OF THOSE FOLKS WILL GET BETTER. OVER TIME, OVER A YEAR. BUT WENT KNOW WHAT THAT WILL OCCUR. 20% WILL DEVELOP [INDISCERNIBLE] BUT THAT WAS BEFORE USING A NEWER CASE DEFINITION. AND WE DON'T KNOW ANYTHING ABOUT DIFFERENT TRAJECTORIES THAT OCCUR DURING THAT POINT. SO DOING A STUDY LIKE THAT, WHICH WE HAVE TO BE VERY IMPORTANT AND THEN, HOPING TO PIGGYBACK ON SOME OF THE--LOOKING AT THE TRANSITION WORK SOME OF THE BIOMARKERS AND OTHER MEASURES THAT THEY HAVE MENTIONED WOULD BE A--WOULD BE A NICE COMBINED TYPE OF STUDY GETTING THOSE BIOMARKERS BECAUSE, YOU KNOW A LOT OF NEW TECHNOLOGY IN TERMS OF MONITORING, MOST PEOPLE HAVE SMART PHONES OR iPADS AND WE'RE PLANNING TO HAVE THEM BASICALLY PROVIDE US WITH INFORMATION ABOUT [INDISCERNIBLE] ON A DAILY BASIS SO WE CAN MONITOR THAT AND LOOK AT THE DIFFERENT TRAJECTORIES AND THEN ALSO SIMULTANEOUSLY MEASURE SOCIOECONOMIC TYPES OF IT. LIKE ARE THEY WORKING? HOW MANY SICK DAYS THEY HAVE? ARE THEY ON DISABILITY? SO ON AND SO FORTH. AND THEN HOPEFULLY WE CAN COME UP WITH BIOMARKERS THAT WILL FLAG THOSE FOLKS EARLY TO HELP IDENTIFY THOSE THAT MIGHT NEED BETTER ATTENTION AT THE BEGINNING TO PREVENT THAT ULTIMATE LEVEL OF CHONNICKITY. AND THEN ONCE PEOPLE ARE AT THE CHRONIC PHASE AND IT GETS COSTLY BECAUSE WE KNOW--WE KNOW THAT IN TERMS OF LOW BACK PAIN, WE KNOW THAT 80% BECOME BETTER AFTER THEY HAVE AN ACUTE EPISODE AND 20% WILL BE COMPLIANT. NOW IF YOU LOOK AT THE PRICE THAT 20%, THAT BECOME CHRONIC THEY BASICALLY EAT UP 80% OF THE HEALTHCARE COSTS AND THAT'S BEEN DOCUMENTED EPIDEMIOLOGICALLY. SO THAT THE GOOD NEWS IS THAT 80% OF ACUTE LOW BACK PAIN PATIENTS WILL GET BETTER ON THEIR OWN. THE BAD NEWS IS THAT THAT REMAINING 20% WILL EAT UP 80% OF THE COST IN TERMS OF DEALING WITH THE LOW BACK PAIN. SO TO PICK THAT UP, THE MONITOR THAT'S WE THINK IT WILL BE IMPORTANT TO LOOK AT. BECAUSE ONCE YOU GET TO THE TERTIARY CARE, IT BECOMES A LOT MORE LABOR INTENSIVE. WE HAVE DEVELOPED TECHNIQUES FOR REEFFECTIVE IN THE PAIN MANAGEMENT PROGRAMS, THAT WILL INCREASE FUNCTIONING AND DECREASE DISABILITY. IT WOULD BE GOOD TO IDENTIFY RISK FACTORS OF--TO IDENTIFY THOSE FOLKS EARLIER AND TAYLOR TREATMENT TO THEM. AND COME UP WITH THE OPTIMAL THERAPY TO USE. YOU KNOW RIGHT NOW FUNCTIONAL RESTORATION IS USED VERY EFFECTIVELY, THE LOW BACK PAIN BUT CAN WE TAYLOR IT BETTER TO MAKE IT MORE TIME EFFICIENT AND COST EFFECT BECAUSE A LOT OF INSURANCE COMPANIES BASICALLY DO NOT AUTHORIZE PAYMENT FOR FUNCTIONAL RESTORATION BECAUSE THEY THINK IT'S TOO COSTLY. WHICH IS RIDICULOUS BECAUSE IT'S LIKE $10,000 PERHAPS FOR A 3 WEEK COURSE OF IT AND THAT IS A LOT LOWER THAN 3 STEROID INJECTIONS. BUT FOR SOME REASON THEY'VE BEEN VERY OPPOSED TO DOING IT BECAUSE PART OF TERTIARY INTERVENTION LIKE FUNCTIONAL RESTORATION, YOU HAVE TO DEAL WITH SOME OF THE PSYCHIATRIC SEQUEL I BECAUSE WHEN PEOPLE BECOME CHRONIC WITH PAIN THEY DEVELOP SOME SIGNIFICANT DEPRESSION, MAJOR DEPRESSION, SUBSIDIARY STANCE ABUSE, AND ANXIETY DISORDERS. AND INSURANCE COMPANIES DON'T WANT TO OPEN UP THAT CAN OF WORMS. WHEN WE DO IT WE DON'T USE THE TERM PSYCHOLOGICAL TREATMENT, WE USE THE TERM BEHAVIORIAL TREATMENT. THEY DON'T GET FRIGHTENED AWAY FROM THAT. BUT ANY EVENT TO COME UP WITH MORE EFFECTIVE MAYBE TIME, MORE COST EFFECTIVE AND TIME EFFECTIVE METHODS FOR THAT, OKAY, NEXT AND THEN THE NEXT SLIDE IS LOOKING AT MEDIATORS AND MODERATORS, I CAME IN EARLY AND THESE ARE IMPORTANT TO CONSIDER AND OF COURSE WITH THE TRANSITION YOU KNOW GENETICS, YOU KNOW DEMOGRAPHICS, LEARNING EXPERIENCE, ENVIRONMENTAL WORKPLACE OR ORGANIZATIONS NATIONAL LIBRARY OF MEDICINICS, THERE'S A HOST THERE THAT WE HAVE, THERE'S SOME DATA ON IT AND THEN SOME OF THE ETICSIO LOGICAL FACTORS THAT WE CAN LOOK AT AND THEN ALSO, THERE'S A BIG LITERATURE ON MEDEIARYS THAT WILL HELP DECREASE THE PAIN PERCEPTION, COPING STYLES OF YOUR SUPPORT AND SO ON. AND THEN AT THE BOTTOM OF THIS LAST SLIDE IS, WHAT I SPOKE ABOUT EARLIER ABOUT WORKING WITH THE TRANSITION WORK GROUP IN TERMS OF THAT WHOLE TRANSITION PROCESS. >> OKAY, GREAT, THANKS SO MUCH FOR THE PRESENTATION, BOB, WE'RE GOING TO OPEN UP FOR JUST A COUPLE OF QUESTIONS HERE. SO, IF YOU COULD LISTEN IN AND--ANYBODY HAVE QUESTIONS FOR BOB? RICARDO AND THEN DAN AND THEN BILL? >> THANK YOU VERY MUCH, I THINK THAT IT IS GREAT WHAT YOU'VE DONE, THAT IS FOCUSING ON BACK PAIN BECAUSE OF THE PREVALENCE. NOW WHAT I'M A BIT CONFUSED HERE IS BY THE NUMBERS YOU USE, THAT 80% OF THE PATIENTS GET BETTER IN TIME, SO I WONDER IF THAT APPLIES TO THE ENTIRE POPULATION? IF YOU HAVE PATIENTS THAT ARE MORE ON THE ELDERLY SIDE? OR SPINAL STENOSIS OR [INDISCERNIBLE], SPONDYLOSIS, DO YOU REALLY THINK THESE PATIENTS 80% ARE GOING TO GET BETTER IN TIME? >> THAT'S A GOOD-- >> SEPARATED BY AGE AND TRY TO STRATIFY THEM MORE. >> YES, THAT'S A GOOD POINT. YEAH, THAT'S A GOOD POINT AND AGE OF COURSE, THAT'S A TSUNAMI THAT'S HITTING US NOW AND 1 OF THE MAJOR--I'M SORRY THEY KEEP MENTIONING LOW BACK PAIN BUT AMONG THE AGING POPULATION, LOW BACK PAIN IS THE MOST PREVALENT TYPE OF DISABILITY BUT UNFORTUNATELY THERE HAVE BEEN NO STUDIES SPECIFICALLY LOOKING AT AN AGING POPULATION. NOW WE HAVE SOME ANECDOTA WORK WHERE FOR EXAMPLE, USING FUNCTIONAL RESTORATION, WE FIND THAT PEOPLE OVER 55, IF YOU WANT CALL THOSE ELDERLY, OR MIDDLE AGE, I DON'T KNOW WHAT TERM WE USE, THEY DO WELL WITH IT BUT YOU'RE QUITE ABOUT SPINAL STENOSIS AND WHAT NOT. BUT EVEN WITH SPINAL STENOSIS AND OTHER SPINAL DISORDERS, SURGERY MIGHT NOT HAVE TO BE NECESSARILY AN OUTCOME, I MEAN A TREATMENT OF CHOICE AND SO WE HAVE TO--THAT'S--AS WE'RE LOOKING FOR RISK FACTORS, CAN WE GET BY WITHOUT SURGERY ON THE ELDERLY? BECAUSE EYE THINK THAT'S VERY IMPORTANT BECAUSE THEY WILL PROBABLY RESPOND POOR AFTER SURGERY THAN IF THEY'RE YOUNGER. >> BOB WE HAVE 2 MORE QUESTIONS FOR YOU. CAN WE BRING UP THE NEXT 1 NOW, DAN AND THEN BILL. >> SURE. >> FIRST AND A COMMENT AND THEN A QUESTION, THE COMMENT IS THAT THERE'S AN EFFORT CONVENED BY ACTION, AMERICAN AMERICAN PAIN SOCIETY AND AMERICAN ACADEMY OF PAIN MEDICINE TO UPDATE A TAXONOMY FOR ACUTE PAIN, PATTERNS THAT WERE RELEASED A YEAR OR 2 AGO FOR CHRONIC PAIN, IT MIGHT BE GOOD TO INFORM SEVERAL OF THE GROUPS ABOUT THIS WORK. IT'S NOT EARTH SHATTERING TOTALLY REVOLUTIONARY, IN FACT IT WAS DELIBERATE THAT THEY HAVE CONTINUITY OF WITH PRIOR SYSTEMS. >> DID ROGER CHOW WORK ON THAT? >> NO. >> THE KEY PEOPLE--ROGER WAS A CO AUTHOR, BUT MIKE KENT AND PATRICK TY WERE THE 2 KEY PEOPLE DRIVING THIS BUT THEN THERE WAS INVOLVEMENT WITH STEAM GRUEL AND BOB DOCKERIN AND SO ON, SO IT'S SOON TO BE SUBMITTED. I DON'T THINK IT'S BEEN SUBMITTED. IT'S NOT REVOLUTIONARY BUT IT WILL LOOK AT HELPING LOOKING AT OVERLAPPING ISSUES DEALT WITH BY THE DIFFERENT GROUPS IT MIGHT BE USEFUL IN TERMS OF TERMINOLOGY AND CONCEPTUALIZATION. >> GREAT. >> THE SECOND POINT IS THAT ON THE CURRENT SLIDE HAVE YOU PROJECTED YOU DO REFER TO MEDIATORS, THERE'S RECENT INTERESTING WORK OF HARVESTING WHITE CELLS FROM PATIENTS BEFORE AN OPERATION AND CHARACTERIZING A PANEL OF THEIR ENFLAMMATORY RESPONSES AS A PREDICTER OF WHO WILL DEVELOP INTENSE OR PERSISTENT POST OPEN MEETING PAIN. SO WITH WE USE THE WORD MEDIATORS, I THINK THESE DAYS SHOULD ENCLUED THE BIOLOGICAL PHENOTYPING OF THE INFLAMMATORY RESPONSE IN THE SUBJECT. >> RIGHT. RIGHT. AND THEN ALSO IN TERMS OF IF THERE IS ANY IMMUNE O SUPPRESSION THAT IS--IS PRESENT BECAUSE THAT THEN WILL EFFECT THE HEALING PROCESS. THAT GOES ON AFTER SOME SORT OF PROCEDURE. I THINK THAT WITH THE WHITE CELLS BUT THEN ALSO IMMUNE SYSTEM MEDIATORS WOULD BE IMPORTANT TO LOOK AT ALSO. >> OKAY, THANKS, WE HAVE 1 MORE QUESTION FOR YOU FROM BILL. >> HI, BOB, THIS IS BILL. >> HI, BILL. >> THANKS FOR THE PRESENTATION, I'M JUST--YOU KNOW I WOULD LIKE TO PROTENTIALLY ADVOCATE, NOT POTENTIALLY BUT ADVOCATE FOR MAYBE A LITTLE HIGHER ROLE FOR ENVIRONMENTAL EXPOSURES. YOU KNOW WIEW TALK ABOUT TRANSITIONAL STATES AND TRAJECTORIES, WE'RE PRETTY GOOD AT ASSESSING A VARIETY OF POTENTIAL ETICSIO LOGICAL FACTORS BUT THE PAIN FIELD PRESENTLY HAS LITTLE IN THE WAY IT VALIDATED INSTRUMENTS TO COLLECT THE INFORMATION RELATED TO EXPOSURES, INJURY, LIFE RELEVANT STRESSORS ACROSS THE LIFE SPAN THAT COULD REALLY BE DETERMINING THESE TRANSITIONAL STATES IN THE SUSCEPTIBLE INDIVIDUALS. >> SURE. >> SO, THOUGH I SEE IT MENTIONED WITHIN THE PRESENTATION, I WOULD JUST, YOU KNOW MAYBE ASK A GROUP TO CONSIDER THAT A LARGER EFFORT BE MADE ON DEVELOPING INSTRUMENTS THAT REALLY DON'T EXIST FOR US WELL NOW, WE'RE LOOKING AT ENVIRONMENTAL EXPOSURES ACROSS THE LIFE SPAN THAT ACCOUNTED BE DRIVING SOME OF THESE TRANSITIONAL STATES. >> YEAH, SO SOMETHING ABOVE AND BEYOND SAY PTSD. >> RIGHT. >> YOU KNOW MORE GENERALIZED TYPE OF STRESSORS. >> SORT OF LIKE LIFE EXPERIENCE SURVEY BUT MORE TOWARDS--TOWARDS PAIN AND PAIN-- >> RIGHT. >> EVENTS THAT WE THINK CAN INFLUENCE TRANSITIONAL STATES AND PAIN. >> YEAH, THAT'S A GOOD POINT. YEAH. [INDISCERNIBLE] >> ALL RIGHT, WE WILL HAVE MENUTES SUMMARIZED BOB SO THAT EACH OF THE WORK GROUPS THAT GOT FEEDBACK WILL BE ABLE TO SEE IT IN THE MINUTES. WELL, THANKS SO MUCH, WE REALLY APPRECIATE YOUR INPUT AND YOUR PRESENTATION AND AS I SAID IF YOU WANT TO STAY TUNED. >> OKAY. >> CHRIS MIASKOWSKI, WILL PRESENT FOR THE ACUTE PAIN GROUP. >> I GUESS IT'S AFTERNOON FOR YOU, MORNING FOR ME BUT ON BEHALF OF THE MEMBERS OF THE ACUTE PAIN WORK GROUP AND MY CO CHAIR, I WOULD LIKE TO THANK YOU FOR THE OPPORTUNITY TO PRESENT THIS UPDATE AND WOULD REALLY WELCOME YOUR COMMENTS. WE HAVE A CONFERENCE ON THURSDAY SO I CAN TAKE THEM BACK TO THE WORK GROUP. >> THIS FIRST SLIDE ILLUSTRATES HOW THE WORK GROUP ORGANIZED THEIR WORK AND HOW I WILL PROVIDE INFORMATION FROM THE GROUP. FIRST OF ALL WE SPENT A FAIR AMOUNT OF TIME TALKING ABOUT THE SCOPE OF THE PROBLEM AND THAT WILL BE EVIDENT IN OURIS DISCUSSION. >> I WANT TO POINT OUT SOME OF THE BARRIERS THAT WE PERCEIVE IN THE CONTEXT OF DOING ACUTE PAIN MANAGEMENT RESEARCH AND THE IMPORTANCE OF THIS AREA IN TERPS OF MOVING THE SCIENCE FORWARD. OUR WORK GROUP BROKE UP INTO 2 SUBGROUPS, 1 THAT ARTUMPAYS LED THAT 1 IS TRYING TO UNDERSTAND THE MAJOR RESEARCH QUESTIONS RELATED TO,A CUTE PAIN MECHANISMS AND THEN I HEADED SUBGROUP THAT LOOKED AT RESEARCH GAPS IN THE AREAS OF PAIN MEASUREMENT AND MANAGEMENT. WE'VE HAD A SERIES OF SUBGROUP MEETINGS AND THEN CAME BACK TOGETHER TO REFINE THE RESEARCH GAPS IN QUESTION SO WE CAN PRESENT TO YOU TODAY. WE STRUGGLED AS HAS BEEN SPOKEN ABOUT BEFORE AROUND THE OPTIMAL NUMBER OF RESEARCH QUESTIONS OR GAPS TO IDENTIFY AND WE HAVE IT DOWN TO ABOUT 6 AT THIS POINT. I THINK WE STARTED WITH ABOUT 15 OR 20 BUT IF SOMEONE MENTIONED PREVIOUSLY, WE DO HAVE SOME OTHER QUESTIONS UNDER THE 6 BIG QUESTIONS. >> I WANTED TO MENTION AND I THINK ALAN MENTIONED THIS, SOME OF THE OTHER WORK GROUPS AS WELL, WE CONDUCTED A BRIEF ONLINE SURVEY OF ANESTHESIOLOGYST AND NURSES INN VOLVED IN PAIN MANAGEMENT TO ASSESS FROM THE FIELD WHAT THEY BELIEVE WERE THE MAJOR RESEARCH GAPS IN THE MEASUREMENT AND MANAGEMENT OF ACUTE PAIN AND I WANTED TO MENTION DIANE AND TIM FOR DOING THE ISURE VEY. BEFORE I PRESENT THE ACTUAL DATA, I WANT TO SAY THERE'S A EYE HIGH LEVEL OF PRESENCE BETWEEN THE WORK GROUPS IDENTIFIED AND THE SURVEY RESPONSES AND I THINK OVERALL WE RECEIVED 30 RESPONSES TO THE SURVEYS VEY. MAY I HAVE THE NEXT SLIDE PLEASE? WE SPENT A FAIR AMOUNT OF TIME TRYING TO UNDERSTAND AND SPEAK ABOUT THE NATURE OF ACUTE PAIN AND I THINK THE MAJOR THEME THAT RESULTED FROM THESE DISCUSSIONS WAS THE NOTION THAT ASHES CUTE PAIN IS FAIRLY HETEROGENEOUSIO GENIUS AND WE'LL SEE THAT IN SOME OF THE RESEARCH GAPS THAT ARE IDENTIFIED AND I THINK MANY TIMES WE THINK OF ACUTE PAIN AND PERHAPS DISPLAYED IT POST OPERATIVE PAIN, BUT AS WE TALKED ABOUT THIS TOPIC IF BECAME VERY CLEAR THAT WE'RE DEALING WITH A LARGE NUMBER OF ACUTE PAIN PROBLEMMINGS. AND I'LL TOUCH A COUPLE THESE, TRAUMATIC PAIN INJURY, PROCEDURE PAIN, LABOR PAIN, ACUTE PAIN ASSOCIATE WIDE VARIOUS MEDICAL PROCEDURES, ACUTE PAIN ASSOCIATED WITH TENSION HEADACHE OR VISCERAL PAIN AND THEN THE NOTION OF ACUTE PAIN CONDITIONS ASSOCIATE WIDE MEDICAL TREATMENT AS WELL AS ACUTE EXACERBATIONS OF CHRONIC PAIN CONDITIONS. SO THAT KIND OF SET THE TONE FOR OUR CONVERSATION TO IDENTIFY GAPS. ANOTHER CONOPPOSITE BEHAVIORIAL PHENOTYPENT OF THE PROBLEM IS THAT OUR UNDERSTANDING REALLY OF THE MOLECULAR AND SURFACE--CIRCUIT LEVEL MECHANISMS THAT CONTRIBUTE TO THE HETEROGENEOUSIO GENERATED AITY OF ACUTE PAIN IS RATHER INCOMPLETE. WE SEE SIMILAR PARALLELS AND I THINK ROGER'S PRESENTATION ALOUDED TO THIS AS WELL THAT WE REALLY DON'T HAVE A CLEAR UNDERSTANDING OF THE BEST APPROACHES TO MEASURE AND MANAGE FOR THE PAIN. AND 1 OF THE KEY POINTS WE MAKE HAS BEEN MOVED THROUGH THE IDENTIFICATION OF OUR RESEARCH STAFF IS THAT WE NEED MORE INDIVIDUAL TAYLORED INTERVENTIONS TO OPTIMIZE THE MANAGEMENT OF ACUTE PAIN. BED I HAVE THE NEXT SLIDE, PLEASE. THE MAJOR UNDERLYING ASSUMPTION OF ALL OF OUR WORK IS THAT--I SHOULD SAY THE MAJOR PAIR BARE TO ALL OF OUR WORK IS WHAT WE WE--WE--YOU CEIVED ON THE ASSUMPTION ON THE PARTICLE OF MANY INDIVIDUALS IS THE PROBLEM OF MANAGING 1 OF PAIN IS 1 THAT IS SOLVED AND WE WERE HERE ON THE SLIDE AND HAVE HAD DISCUSSIONMAJOR UNRESOLVED ISSUES AND 1 THAT PERSISTS, ACUTE PAIN IN SOME SITUATIONS CAN BE HIGHLY RESISTANT TREATMENT SUGGESTING WE NEED IMPROVEMENT STRATEGIES. WE HAVE HAD SOME DISCUSSION ABOUT MORE ABOUT THIS ABOUT THE TRANSITION FROM PERSISTENT ACUTE PAIN TO THE INCREASED RISK FOR THE DEVELOPMENT CHRONIC PAIN AND THE OTHER CONVERSATION THAT WE SPENT A FAIR AMOUNT OF TIME ON, THE NOTION OF THE RISK ASSOCIATED WITH OPIOIDS WHICH IS THE MOST COMMON TREATMENT FOR THE MANAGEMENT OF MANY ACUTE PAIN CONDITIONS, NOT ONLY NUMEROUS ADVERSE EVENTS ASSOCIATE WIDE THAT BUT ALSO RISKS ASSOCIATED WITH OCCURRENCE OF ADDICTED AND MISUSE. AND THAT'S SUGGESTS TO US THAT WE NEED NEW INTERVENTIONS FOR ACUTE PAIN. NEXT SLIDE. SO I HAVE 3 SLIDES THAT SUMMARIZE THE RESEARCH GAP THAT WE'VE IDENTIFIED AND WOULD LIKE TO PUT FORTH FOR YOUR CONSIDERATION. I HAVEN'T HIGHLIGHTED ALL THOSE THAT SUPPORT THE RESEARCH GAPS, AND THE RESEARCH QUESTIONS ON THE SLIDES BUT I'LL TRY TO POINT SOME OF THEM OUT. THE ACUTE PAIN MECHANISM SUBGROUP THOUGHT THAT THE 2 MAJOR QUESTIONS RELATED TO WHAT ARE THE MOLECULAR MECHANISMS THAT CONTRIBUTE TO HETEROGENEITY AND THE ACUTE PAIN AND THEN WHAT ARE THE CELLULAR MECHANISMS THAT CONTRIBUTE TO THE HOTTER O GENERATED AITY IN ACUTE PAIN. UNDER THE MOLECULAR MECHANISM QUESTION, IT WAS POINTED OUT THAT WHILE WE HAVE A FAIRLY GOOD UNDERSTANDING OF THE MECHANISMS THAT MODULATE MECHANICAL STIMULI, LESS IS KNOWN PERHAPS ABOUT THINGS LIKE THE MODULATION OR THE MECHANISMS THAT UNDERLIE THE OPTION AS A STIMULUS FOR ACUTE PAIN. FROM THE PERSPECTIVE OF THE CELLULAR MECHANISMS, THERE'S A RECOGNITION THAT THERE'S A LARGE AMOUNT OF NOCICEPTOR HETEROGENEITY. WE KNOW A FAIR AMOUNT ABOUT CUE TANIOUS ACTIVATION BUT IN THE DOCUMENTS THAT WERE PROVIDED TO YOU, WE REALLY HAVE VERY, VERY LITTLE INFORMATION ABOUT HOW BONES OR MUSCLE AND THE VISCERA, HOW THOSE ARE ACTIVATED IN RESPONSE TO THE NOXIOUS STIMULI. WITH A FAIR AMOUNT OF CONSIDERATION AROUND THE NOTION OF TRYING TO UNDERSTAND HOW THE AUTONOMIC NERVOUS SYSTEM INPUT IS REDUCED TO ACUTE PAIN. STIMULARLY, WHAT IS THE DISTRIBUTION OF THE NEURAL NETWORK, HOW DO THEY PLAY, IN TERMS OF CONTRIBUTING TO THE VARIOUS TYPES OF ACUTE PAIN AND THEN IMPORTANTLY WHAT NEW DIRECTION THATNY NEEDS TO BE UNDERSTOOD IN TERMS OF THE CIRCUITRY THAT UNDERLIES THE MODULATION. SO THERE WILL BE TAKEN QUITE A NUMBER OF TOPICS AND TONE THEM DOWN INTO THESE CONCEPTS THAT ARE MOLECULAR CELLISM. SO UNDER THE MEASUREMENT, WE DISCUSSED PRECLINICAL NEEDS OR RESEARCH GAPS IN THE MEASUREMENT OF, CUTE PAIN AND THEN CLEANICAL ISSUES IN THE MEASUREMENTS OF ACUTE PAIN. THAT WOULD LEAD TO MORE EFFECTIVE MANAGEMENT IT WAS A GENERAL CONSENSUS AMONG THE GROUP THAT WE DO NEED TO DEVELOP SOME NEW PRECLINICAL MODELS OF NOR NATURALLY OCCURRING THEME CONDITIONS. AND THE EXAMPLES I GAVE YOU THERE WERE FRACTURES AND BURNS. WE THINK 1 APPROACH THAT MAY ENHANCE THE MEASUREMENT OF ACUTE PAIN AND PRECLEANICAL MODELS IS TO THINK ABOUT AND DEVELOP MORE AUTOMATED MODELS THAT CAN CAPTURE DATA ALMOST IN REALTIME IN ANIMAL STUDIES THAT WOULD ALLOW US TO BETTER UNDERSTAND TEMPORAL PATTERNS ASSOCIATED WITH PAIN. IN TERMS OF THE FULL DOCUMENT IN TERMS OF ASSESSMENT OF PAIN, WE HAVE A LARGE NUMBER OF BULLETS TO CONSIDER, BUT WE BOILED THE RECOMMENDATION DOWN INTO 1 LARGE PATIENT BEING TO IDENTIFY OPTIMAL ASSESSMENT PARAMETERS AND BY PSYCHOSOCIAL PREDICTED ACUTE PAIN AS TO OPTIMIZE PAIN MANAGEMENT. AND WE HAD A LOT OF DISCUSSION THAT IT'S TIME TO MOVE BEYOND THE 0-10 SCALE. WE'RE NOT GOING TO DEVELOP INDIVIDUALIZED STRATEGIES TO EFFECTIVELY MANAGE ALL THE DIFFERENT TYPES OF ACUTE PAIN IF WE CONTINUE TO SIMPLY RELY ON IF THERE IS A 10 NEWELLERRIC RATING SCALE. AND THE GENERAL CONSENSUS IN OUR WORK GROUP WAS THAT WE REALLY NED TO DEVELOP, AND DISCUSS TOOLS THAT CAN BE USED TO INFORM CLINICAL DECISIONS AND IMPROVE PATIENT OUTCOMES. SO THEY MAY TAKE VERY DIFFERENT FORMS INCLUDING--ENCLUEDING VARIOUS PHYSICAL AS WELL AS PSYCHOSOCIAL DOMAINS. WE HAD SOME DISCUSSION ABOUT THE USE OF BIOMARKERS IN THE CONTEXT OF ACUTE PAIN AND WE DIDN'T FINISH THAT DISCUSSION SO I WOULD BE INTERESTED HEARING THE COMMITTEE'S COMMENTTHAT. IT WAS DAN CARR THAT MIGHT HAVE SPOKEN BEFORE BUT I WASN'T SURE ABOUT THAT. MAY I HAVE THE LAST SLIDE? IN TERMS OF THE MANAGEMENT PERSPECTIVE, THE QUESTIONS OR AREAS FOR FURTHER INQUIRY INTO 2 BROAD GROUPS. ONE IS THE INDIVIDUAL AND THE SECOND IS THE HEALTHCARE SYSTEM, AND WE BEING THEY'RE BOTH EXTREMELY IMPORTANT AT THIS POINT IN TIME. WE BELIEVE AND AGAIN UNDER THESE 2 AREAS, I SELECTED A COUPLE OF THE LIFT POINTS IN CONSIDERATION OF WHAT WE'VE BEEN SPEAKING ABOUT. ON THE INDIVIDUAL LEVEL AND BETTER MANAGEMENT OR IDENTIFY STRATEGIES TO IMPROVE ACUTE MANAGEMENT OF PAIN, WE BELIEVE IT'S CRITICAL TO DEVELOP NON--NEW PHARMACOLOGIC AS WELL AS NONPHARMACOLOGIC TREATMENTS FOR PAIN. AND TO DETERMINE WHETHER OR NOT PHARMACOLOGIC AND NONPHARMACOLOGIC APPROACHES PERHAPS SYNERGIZE TO BE USED MOSTISKIVELY FOR VARIOUS TYPES OF PATIENTS. WE HAD A LOT OF DISCUSSION IN THE WORK GROUP ABOUT THE WHOLE NOTION OF COMPLEX PATIENTS, PATIENTS WITH MULTIPLE CO MORBID CONDITIONS, AND TRYING TO UNDERSTAND INDIVIDUALS AND DEVELOP STRATEGIES THAT ARE GOING TO REDUCE MORBIDITY ASSOCIATE WIDE OMISSIONS AND OMISSIONS IN ACUTE PAIN MANAGEMENT. WE ACKNOWLEDGED THAT THE SYSTEM LEVEL INTERVENTION ARE GOING TO BE I THINK CHALLENGING TASKS. BUT WE NEED TO THINK THROUGH AND DEVELOP AND EVALUATE NEW MODELS OF CARE, THAT WILL OPTIMIZE PAIN MANAGEMENT AND THAT THOSE MODELS OF CARE SHOULD BE-TO GO BEYOND THE IN-PATIENT SETTING, YOU NEED TO THINK ABOUT MODELS OF CARE IN PAIN MANAGEMENT IN AMBULATORY SETTINGS AS WELL AS IN HOME CARE SETTINGS AND THEN, A LOT OF CONVERSATION AT THE SYSTEMS LEVEL ABOUT BEING ABLE TO TRY TO IDENTIFY PERRY OPERATIVE RESOURCES TO BE ABLE TO ALIGN AND HAVE TIME TO PROVIDE PATIENTS BOTH PHARMACOLOGIC AND NONPHARMACOLOGIC BASED ON INDIVIDUAL NEEDS. I SHOULD HAVE BULLETED THE NEXT SLIDE. WE DO HAVE YOU SHOULD THE MANAGEMENT ISSUES, OPTIMAL METHODS TO EDUCATE PATIENT AND IT IS CLINICIANS ABOUT OPTIMAL PAIN MEDS. SO I THINK I WILL STOP THERE AND SEE IF THERE'S QUESTIONS OR COMMENTS. I APPRECIATE IF YOU COULD IDIDN'TIFY WHO'S SPEAKING? >> SURE. SNRKTS. >> YES, THEY THINKS CHRIS, THIS IS LINDA WE WILL OPEN IT UP FOR QUESTIONS NOW. I JUST WANT TO CHECK WITH YOU THAT YOU'LL BE ABLE TO STAY LONGER IN TIME THAN WE ORIGINALLY PLANNED WE'RE RUNNING ABOUT 15 MINUTES LATE. OKAY, WE'LL COME BACK TO SEDDON. SHE HAD CHECKED IN. QUESTIONS FOR CHRIS PLEASE? >> LOOKS LIKE YOU WERE VERY THUNDERSHOWER O, CHRIS. >> I WOULD JUST REMIND PEOPLE THAT IN YOUR PACKET IS A LIST AND AN EXPANSION OF THE INDIVIDUAL POINTS AND THAT'S WHAT YOU'LL EXPECT TO SEE. >> CAN I ASK THE GROUP A QUESTION? >> SURE. >> I WOULD BE INTERESTED IN PEOPLE'S THOUGHTS ABOUT THE BIOMARKER QUESTION. WE'VE HAD A FAIR AMOUNT OF DISCUSSION ABOUT WHETHER OR NOT THIS IS GOING TO--THIS KIND OF A RECOMMENDATION WILL BE USEFUL IN TRYING TO PROFILE PATIENTS RELATED TO ACUTE PAIN. >> WELL, CAN I BRING UP SOMETHING THAT CAME UP AT THE STEERING COMMITTEE. >> PLEASE, YES. >> SO IN TERMS OF HIGHLIGHTING THE BIG ISSUE OF THE GOLD, WELL SOMEONEOT STEERING COMMITTEE AND I WON'T MENTION NAMES FELT THAT IT WAS TIME AND THEY WERE DISAPPOINTD, THIS INDIVIDUAL WAS PARTICULARLY DISAPPOINTED THAT A HUGE GWAS STUDY WAS NOT BEING PROPOSED FOR EITHER ACUTE OR CHRONIC PAIN AND WE'RE NOT TALKING ABOUT A HUNDRED PATIENTS OR 500 PATIENTS, THE ANALOGY WAS DRAWN TO THE SCHIZOPHRENIA SAMPLE AND IT WAS JUST IN THE NATURE OF NEUROSCIENCE STORY. A MILLION PATIENTS OVER 5 YEARS IS WHAT'S BEING DONE AND I'M SURE WALTER'S VERY HAPPY. BUT THIS IS A HUGE PROJECT AND OF COURSE, IT'S--YOU NEVER KNOW WHAT THE RESULT WILL BE BUT GIVEN THE HETEROGENEITY OF THE PROBLEM, THE FEELING WAS THAT IF YOU'RE LOOKING FOR A BIOMARKER, THAT'S THE MOST PLAUSIBLE TO GO AFTER UNLESS YOU CAN FIGURE OUT TO IMAGE A MILL WHEREON PATIENTS SO I DON'T KNOW WHAT DAN THINKS ABOUT THAT? >> I WASN'T GOING TO COMMENT BECAUSE THE 3 MONTH LINE THAT YOU TRIP OVER BECOME A CHRONIC PATIENT PATIENT AS SUCH A SACRED COW BUT BECAUSE OF BIOMARKERS I COULD NOT HELP MYSELF. AFTER 15 YEARS OF WAR, I'VE SEEN PATIENTS EXHIBITING CHRONIC PAIN WITHIN 3 DAYS AND IT BOTHERRINGS ME WE CONTINUE TO HOLD SO TENACIOUSLY TO THIS CONCEPT WHAT I THINK IS A SPECTRUM OF DISEASE AND I REASON I MENTION THIS NOW WITH BIOMARKERS AND I THINK WE WILL FIND AS WE START DELVING INTO THIS AREA THAT WE WILL BE ABLE TO BE PREDICTIVE WITH BETTER DOMAINS OF BIOPSYCHOSOCIAL MEASUREMENT FOR PATIENT REPORTED OUTCOMES SUCH AS WHAT PROMISE OFFERS, TACHING THOSE TO BIOMARKERS THAT WE WILL FIND IN OUR PATIENTS AND BE ABLE TO PROVIDE PREDICTIVE MODELS OF THOSE PATIENTS THAT WILL GO ON TO HAVE PERRISTENT PAIN WHICH IS A BETTER TERM AS WE BEGIN TO UNDERSTAND UNDERSTAND PAIN AS A SPECTRUM OF DISEASE AND NOT ISOLATE INTOED THESE 2 SILOS WHICH I THINK IS DONE BOTH ACUTE AND CHRONIC PAIN A BIG DISSERVICE AND ITS MANAGEMENT. THANKS? , LINDA? >> OKAY, SO, YEAH, CHRIS, HI, DAN THAT WAS ME THAT TALKED ABOUT BIOMARKERS, I THINK THAT WHAT I WAS REFERRING TO WAS A POST DOC PAYING STUDY IN WHICH A VARIETY OF A PANEL OF RESPONSES OF HARVESTED WHITE PLOD CELLS FROM A PERIPHERAL PLOD SAMPLE WERE CHARACTERIZED AND THEY SEEM TO ACCOUNT FOR THE VARIANCE WHICH IS COMPARABLE BUT LET'S SAY TO MANY GENETIC MARKERS NOW. OT OTHER HAND. ALSO IN COMPLEX REGIONAL PAIN SYNDROME ALTHOUGH I CAN'T SAY I UNDERSTAND THE PATHOPHYSIOLOGY, THERE ARE SOME INFERENCES THAT SUGGEST AN INTERACTION SO THIS WOULD BE A VOTE FOR ADDING IN IMMUNE OR OTHER BIOMARKERS WHILE OF COURSE CONTINUING ATTENTION TO NEURAL MARKERS, 1 OTHER LAST THOUGHT KNOWING HOW MUCH WORK YOU'VE DONE IN ACUTE PAIN AND QUALITY IMPROVEMENT, I THINK I RECALL THAT WHEN THE AGE TAPS PAIN QUESTIONS WERE D-LINKED FROM PAYMENT, A COUPLE OF MONTHS AGO, I THOUGHT I SAW THAT CMS WAS DEVELOPING OR HAD SOME PROCESS TO DEVELOP OR IMPROVE PAIN RELATED QUESTIONS. SO I DON'T KNOW IF THAT WAS A POLITICALLY CORRECT THING TO SAY OR FUNDING BUT IF THEY REALLY DO, WANT TO LIVE UP TO WHAT THEY WERE SAYING I THINK IT WOULD BE CATASTROPHIC FOR PAIN QI AND BIG DATA TO SIMPLY STOP REPORTING PAIN SCORES OR NOT USE ANYTHING AT ALL BECAUSE YOU FOUND FLAWS WITH WHAT'S THERE. SO I WONDER IF SOMEONE MIGHT INVESTIGATE WHERE DOES THAT HUGE SAMPLE SIT? BECAUSE THAT'S A HUNDRED PERCENT SAMPLE OF A LOT OF PATIENTS. >> THANKS, DAN. >> YEAH. >> HI, CHRIS THIS, IS BILL. >> HI. I WANT TO COMMENT AND I THINK 1 OF THE DIFFICULTIES WE HAVE IS WHAT DO WE MEAN BY A BIOMARKER, IT SEEMS TO BE A CATCH ALL TERM FOR MANY, I GUESS DIMENSIONS THAT WE THINK ARE ETICSIO LOGICAL PATHWAYS FOR PAIN CONDITIONS, I THINK, YOU KNOW THE CONCEPT IS MOLECULAR PROFILES. TO ME THAT IS A BETTER WAY TO THINK ABOUT THIS AND THE MOLECULAR PROFILES IN MY MIND ONLY MAKE SENSE WHEN WE BEGENERATED TO RESPECT THE HETEROGENEITY OF THIS CONDITIONS. WITHOUT SO, IT TAKESSA I MILLION PATIENTS TO FIND A MARKER THAT SHANES A SMALL AMOUNT OF VARIANCE IN A CASE DEFINITION THAT IS VERY HETEROGENEOUS ROW GENIUS. I THINK WHEN YOU BEGIN TO USE BIOPSYCHOSOCIAL MEASURES, THIS AS TRIP JUST ALOUDED TO AND STRATIFY THE POPULATION INTO SUBGROUPS, THEN I THINK THE CONCEPT OFUTESSING THOSE STRATATO LOOK AT MOLECULAR PROFILES, YOU KNOW HELPS POINT TO NEW TARGETS AND HELPS IDENTIFY, YOU KNOW MORE PRECISION OR TAYLORED LIKE TREATMENT TO SUBSTRATAOF A GIVEN CONDITION. SO I THINK JUST THE CONCEPT OF BIOMARKERS IS IN MY MIND SOMEWHAT PROBLEMATIC. I THINK IT WILL NOT HAVE MUCH MEANING AND LESS PHENOTYPE AND THE USE OF PHENOTYPES TO PRODUCE STRATAWILL HELP INFORM THE MOLECULAR PROFILE OF THOSE STRATA. >> ARE YOU THINK OF THE GWAS? >> NOT SO MUCH, I'M THINKING, YOU KNOW, I'LL JUST GIVE AN EXAMPLE THAT I'M FAMILIAR WITH, WHERE, IN THE OPERA STUDY, WE TOOK SEVERAL THOUSAND INDIVIDUALS AND IDENTIFIED ESSENTIALLY 3, 3 POPULATIONS THAT WE CALL CLUSTERS AND THE BIOPSYCHOSOCIAL PROFILES OF THOSE 3 CLUSTERS DIFFER QUITE SUBSTANTIALLY AND THE TEAM D PATIENT THAT FALLS WITHIN EACH OF THESE 3 CLUSTERS DIFFERS SUBSTANTIALLY AND AND THE DIFFERENT, IF YOU WILL MOLECULAR PROFILES OF THESE 3 CLUSTERS ALSO DIFFERS SUBSTANTIALLY WITH RESPECT TO CYTOKINES, WITH RESPECT TO GENETIC VARIANCE. SO IT'S, YOU KNOW THE THOUGHT I PRESENT THAT WE MUST FIRST OF ALL RESPECT THE HETEROGENEITY OF THE PATIENT POPULATION BASED ON PRESENTATION OF SIGNS AND SYMPTOMS, PUT THEM INTO THE RIGHT--INTO CATEGORIES THAT WE CAN ASSESS CLINICALLY AND THEN LOOK AT THE MOLECULAR SUBSTRUCTURE UNDER EACH OF THESE CATEGORIES WHICH WILL THEN INFORM POTENTIAL TARGETS FOR THOSE POCKETS IF YOU WILL AND NEW TREATMENT OPTIONS FOR THESE INDIVIDUALS. SO I DON'T USE BIOMARKERS IF YOU WILL NECESSARILY IN DIAGNOSTIC CRITERIA BUT I DO USE THE CONCEPT OF MOLECULAR PROFILES AS HELPING IDENTIFY POTENTIAL TREATMENT OPTIONS AND TARGETS BY SUBSTRATA. CONCERN EMPLOY. >> GREAT. I WILL TAKE THAT BACK, THAT'S AN INTERESTING IDEA. MAYBE ACROSS ALL THE WORK. >> YOU GET THEN, YOU DON'T NEED A MILLION FOLKS. >> RIGHT. >> YOU BEGIN TO SEE THAT THE VARIANTS, YOU KNOW IN THE GROUP, BEGINS TO DIMINISH AND AND WEAK SIGNALS. >> I'LL BRING THAT BACK TO THE STEERING COMMITTEE. >> TRIP 1 QUICK POINT POINT, YOU WILL BE PLEASED TO HEAR FROM THE LAST 2 GROUPS THAT EXACTLY WHAT YOU BROUGHT UP IS A BIG TOPIC THAT THE DEFINITION, TIMES WHEN IT'S CHRONIC YOU'LL HEAR MORE ABOUT THAT IN A MOMENT. >> YEAH, DAN WAS JUST ADMONISHING ME FOR BEING BASHFUL AND-- >> WHO? >> WOW. >> HE'S NOT THE BEST JUDGE OF CHARACTER. BUT, BIOMES WAS ANOTHER THING I WOULD ADD TO THOSE MARKERS WE SHOULD BE LOOKING AT GUT BIOMES AS WE'RE GOING FORWARD. >> GREAT, THANK YOU. >> THANKS VERY MUCH, WE WILL MOVE ON WE HAVE A BIT OF TIME AT THE END OF ALL 5, BUT WE WANT TO MAKE SURE WE DON'T LOSE SEDDON, BECAUSE SHE'S IN THE MIDDLE OF ANOTHER MEETING. SO TED, YOU ARE UP NEXT. TED PRICE OF THE TRANSITION GROUP. >> HI, EVERYBODY, SO I THINK I CAN BE PRETTY QUICK. MOSTLY BECAUSE A LOT OF THE WORK WE'VE BEEN DOING AS BEEN DISCUSSED IN 1 WAY OR ANOTHER AND IN FACT, THE QUESTIONS AND IDEAS THAT BILL WAS JUST RAISING HAVE REALLY BEEN A BIG PART OF THE DISCUSSION THAT WE'VE HAD. SO WE HAD AN IN-PERSON MEETING 2 WEEKS AGO, WE A LARGE NUMBER OF PHONE CALLS AND WHAT WE'VE STARTED IF YOU CAN GO AHEAD TO THE NEXT SLIDE, WITH SOME OVERARCHING ISSUES, YOU GO TO THE NEXT SLIDE. SO OVERARCHING ISSUES THAT GO TO THE SACRED COW ISSUE OF WHAT CHRIS SAID IN THE FIRST TALK. SO WE'VE ALL BEEN THINKING ABOUT THIS ISSUE AND WHEN DOES IT OCCUR AND WILE WE HAVE LOTS OF IDEAS ABOUT MECHANISMS, I THINK THAT THE GROUP AS A WHOLE HAS DECIDED THERE ARE A LOT OF OVERARCHING CONCEPTUAL ISSUES THAT WE'RE NOT PARTICULARLY CLEAR ON. WE HAD THOUGHTS AND QUESTIONS IN TERMS OF WHETHER THE CURRENT DEFINITION OF CHRONIC PAIN IS USEFUL FOR THINK BEING HOW THIS HAPPENS. A LOT OF DISCUSSION ABOUT PEOPLE THAT ARE DEVELOPING ACUTE AND CHRONIC PAIN AT THE SAME TIME AND MAYBE THERE'S NO TRANSITION AT ALL SO WE'VE BEEN WORKING ON LANGUAGE TO KINDS OF CAPTURE ALL THESE IDEAS, TOGETHER AS KIND OF A PREAMBLE TO OUR TEAM. AND WE CAN GO TO THE NEXT SLIDE, THEN. SO OUR 3 THEMES ARE PLASTICITY AND RESOLUTION AS POSITIVE OR RESOLVING FACTORS FOR TRANSITION TO CHRONIC PAIN. THIS PARTICULAR THEME START WIDE DISCUSSION OF THE HYPOTHESIS THAT WE THOUGHT WERE RESPONSIBLE FOR THE TRANSITION IN CHRONIC PAIN AND THOSE WERE NUMBER 1, A FAILURE OF RESOLUTION, NUMBER 2, NEUROIMMUNE INTERACTION, NUMBER 3, DEFENDING AND CENTRAL MODLATTORY MECHANISMS AND 4 INTRINSIC FLUORONAL PLASTICITY AND BASICALLY WE DECIDE THAD WHAT WE ALL THINK THOSE ARE PERFECTLY GOOD I HYPOTHESIS AND HAVE GOOD SUPPORT SOME SMOTELY THE PRECLINICAL LITERATURE AND WHERE WE THOUGHT THOSE WERE LACKING WAS GOING BETWEEN THE PRECLINICAL WORK AND THE PRECLINICAL WORK, TO TEST WHETHER THESE HYPOTHESIS WERE OCCURRING IN SUBSETS OF PATIENTS. IF WE COULD IDENTIFY TOOLS THAT COULD BE USED TO DO WHAT WE'RE CALLING MOLECULAR NEUROSCIENCE AND THERE ARE A VARIETY OF IDEAINGS HERE ABOUT HOW THAT MIGHT BE ANAL TO BE DONE. WHICH SOME OUR--SOME OF THOSE ARE TECHNOLOGY DEVELOPMENT, OTHERS ARE TRYING TO DO THINGS IN PRECLINICAL MODELS THAT CAN ALSO BE DONE IN THE CLINIC. FOR INSTANCE CSF MEASURES OF CERTAIN POTENTIAL MEDIATORS. AND FINALLY TO GET INTO THE LEVELS TO WHICH ANY HAVE COME OUT OF THE BRAIN INITIATIVE AND THEN FINALLY PUSHING FOR MORE DRUG DEVELOPMENT AND DISCOVERY AND MOVING THOSE FORWARD AND WORKING WITH THEM. SO THE NEXT THEME, THE NEXT SLIDE IS IS DEVELOPMENT OF CHRONIC PAIN, LIFE SPANS OF PAIN THROUGHOUT WE STARTED WITH THOSE WITH NEAL AND BOB HIGHLIGHTED THAT THERE ARE CERTAIN KINDS--DURING OR JUST BEFORE ADOLESCENCE WHERE IT SEEMS TO BE THE CASE THAT INJURIES THAT WOULD CAUSE DEVELOPMENT OR TRANSITION TO CHRONIC PAIN AT MOST OTHER TIME POINTS DON'T SEEM TO DO THAT SO THAT LED TO THE IDEA OF THEIR BEING NOT ONLY MECHANISMS THAT DRIVE TRANSITION BUT ALSO MECHANISMS THAT ARE PROTECTIVE AGAINST THE TRANSITION AND THOSE ARE LARGELY NOT KNOWN. AND FINALLY JUST RECOGNIZING AS ROGER STARTED US OFF WITH WAS SEX DIFFERENCES AND MECHANISMS THAT THESE ARE OBVIOUSLY CRITICAL AND PROBABLY CRITICAL ACROSS THE LF SPAN AND ENDING WITH--WE JUST FRANKLY DON'T KNOW VERY MUCH ABOUT DIFFERENCES IN TRANSITION MECHANISMS, AND EVEN DIFFERENCES AND ACUTE PAIN MECHANISMS IN THE ELDERLY. AND FINALLY OUR THIRD MAJOR THEME IS RISK PROTECTION AND RESILIENCE. SO WE FOUL LICK A FAIR AMOUNT OF PROGRESS IS MADE AND IDENTIFYING RISK FACTORS IN CERTAIN POPULATIONS, CHRONIC POST SURGICAL PAIN PROBABLY BEING THE MOST OBVIOUS 1S BUT THAT A LOT OF THESE PRINCIPLES HAVE NOT BEEN APPLIED NECESSARILY ACROSS DIFFERENT TYPES OF PAIN SO ARE THERE OPPORTUNITIES TO LOOK FOR SIMILARITIES AND CAN WE START IMPLEMENTING MECHANISTIC CLINICAL TRIALS EARLIER TO TEST THESE MECHANISMS THAT WERE INTERESTED AND THEN FINALLY ARE THERE ACUTE PAIN MANAGEMENT STRATEGIES THAT ARE ACTUALLY MAKING THE TRANSITION TO CHRONIC PAIN WORSE. SO, YOU KNOW, I THINK THERE'S QUESTION AS TO WHETHER OPIOIDS MIGHT BE DOING THIS, AND THEN WE KNOW, A LITTLE BIT ABOUT MECHANISM, MAYBE FOR PRECLINICAL MODELS BUT AGAIN MUCH LESS IN THE CLINIC. SO THAT'S ANOTHER AREA THAT WE THOUGHT THAT NEEDED TO BE HIGHLIGHTED, AGAIN. FROM WHAT I HEARD FROM THE OTHER GROUPS TODAY, AND THEN WE HAD A PHONE CALL WITH BOB'S GROUP, ALSO THERE SEEMED TO BE QUITE A BIT OF COMMONALITIES THAT ARE EMERGING FROM THESE SO I THINK THESE WILL BE REALLY EXCITING WORK ONCE ALL THE CO-CHAIRS COME TOGETHER TO LOOK AT OUR OVERARCHING PRIORITY WITH THE EMERGING VERY RAPIDLY WHAT EVERYBODY'S SAYING TODAY. AND I'LL TAKE QUESTIONS. >> THANKS SO MUCH, TED, QUESTIONS FOR TED? CINDY? >> THANKS THIS MIGHT NOT AT ALL FIT INTO THIS BECAUSE SOME OF THIS IS WAY OUT OF MY LEAGUE, AND I'M INTERESTED TO LEARN MORE BUT WHAT ABOUT THE IDEA OF LIKE A TIPPING POINT IN PAIN. SO IN OTHER WORDS YOU MIGHT HAVE MULTIPLE ASSAULTS OVER A PERIOD OF TIME THAT THEN TIP YOU INTO BEING CHRONIC VERSUS NOT? OR A NUMBER OF SORT OF TIPPING POINTS LIKE THE REPEATED, YOU KNOW CHEMICAL ISSUES THAT TIP YOU INTO BEING CHRONIC THAT FIT IN THIS IN ANY WAY? >> I THINK THAT WAS ACTUALLY A BIG PART OF THE HYPOTHESIS THAT WERE COMING UP IN OUR FIRST THEME. SO, WE TALKED ABOUT MULTIPLE [INDISCERNIBLE]. HOW PRIMING CAN OCCUR IN THE IMMUNE SYSTEM AND THAT THAT HAS CREATED CHANGES IN CIRCUITRY THAT CAN ALTER THE RESPONSE BUT THAT THERE'S A FURTHER INSULT OR STRESS OR LIFE EVENT. SO, I THINK THAT THAT WAS SOMETHING THAT WE SPENT A LOT OF TIME ON, TALKED ABOUT IN THIS 1 AND IS AN IMPORTANT KIND OF CONCEPTUAL ISSUE THAT WE'RE GRAPPLING WITH FOR OUR OVERARCHING ISSUE. >> I MEAN I JUSTED WANT TO POINT OUT THAT WHAT BILL WAS TALKING ABOUT RIGHT BEFORE I CAME ON WAS REALLY A HUGE PART OF WHAT WE SPENT OUR TIME TALKING ABOUT. SO, THAT'S A REALLY IMPORTANT ISSUE AND SOMETHING THAT OUR GROUP HAS REALLY BEEN ENGAGED WITH IN TERMS OF THINKING ABOUT WHAT KIND OF TECHNOLOGY COULD BE DEVELOPED TO MOVE THIS EVEN FURTHER FORWARD. >> THAT WAS GREAT AND I JUST HAVE A SMALL COMMENT. BOTTOM BULLETOT CURRENTLY PROJECTED SLIDE, DO SOME ACUTE PAIN MANAGEMENT STRATEGIES TRIGGER AN ENCOUNTER, I WOULD URGE CAUTION IN APPLYING THE WORD OPIOID-INDUCED HYPER ALGEESIA, LET'S SAY TO A HYPER ALGEEZIA THAT FOLLOWS AN INFUSION OF A HIGH POTENCY OPOIOID LIKE REIN, I FIENT NOLL, I JUST HEARD A GREAT PRESENTATION FROM SOMEONE FROM ILANICEN BERG'S LAB WHO DOES A LOT OF WORK ON OPIOID INDUCED STATES, BUT I WOULD SUGMITT THAT IF YOU CAREFULLY AT THOSE STUDIES IN ACUTE PAIN, THERE'S AT LEAST AS MUCH OF AN ARGUMENT TO SAY THAT WHAT YOU ARE YOU'RE STAYING IS ACUTE WITHDRAWAL BECAUSE WHEN YOU SHUT OFF THE MEDICINE IS A SUBJECT TO WHAT'S WITHDRAWING BUT NOT 1 WHO MEETS THE CRITERIA, I KNOW THERE'S A WHOLE POLITICAL AGENDA OR WHATEVER, BUT THIS F THAT'S THE CODE WORD BETWEEN THE LINES FOR THAT THIRD BULLET, I URGE CAUTION IN BRINGS UP THE TERM OPIOID INDUCED HYPER ALGEEZIA, EACH THOUGH YOU DIDN'T DON HA IN THE BULLET ITSELF. >> THATYA I WONDERFUL POINT. I WILL CONVEY IT TO THE GROUP. I DON'T THINK IT WAS CODE FOR WORD FOR THAT. I THINK WE WERE THINK BEING IT IN A DIFFERENT CONTEXT BUT YOUR POINT IS WELL TAKEN AND WILL BE COMMUNICATED BACK TO THE GROUP. >> JAN THEN JOSE. >> HI, TED TRIMBLE, THIS IS JAN CHAMBERS I APPRECIATE BEING ABLE TO WORK ON THIS GROUP, THAT IS A VERY IMPORTANT POINT AND 1 PIECE WE DID TALK ABOUT ON THAT POINT WAS THAT ACTUALLY NOT ADDRESSIVELY TREATING PAIN IN THE INITIAL TRAUMA OR WITHHOLDING TREATMENTS THAT WOULD CAUSE THE BODY TO LATER PERFORM DIFFERENTLY SO I APPRECIATE WHAT YOU'RE SAYING, DAN BUT I THINK THAT'S A DIFFERENT PERSPECTIVE AND WE HAVEN'T HEARD TODAY. THANK YOU. >> BILL? >> YEAH, YEAH, TED, THANKS. I'M CURIOUS, TED, AND THIS MAYBE GOES ACROSS THE OTHER GROUPS, ESPECIALLY WHEN WE'RE TALKING ABOUT SOME OF THE PRECLINICAL MODELS WHERE WE'RE USING PRIMARILY INBRED STRAINS AND WHETHER THAT REALLY CAPTURES AND MAYBE LEADS TO THE CONCEPT OF LOSS AND TRANSLATION AND SO, HAVE THERE BEEN ANY DISCUSSIONS ABOUT THE NEED FOR OUTBRED STRAINS, MORE IF YOU WILL, WILD MICE, WILD RATS WHERE YOU GET A POPULATION BASED ASSESSMENT LOOKING REALLY NOT ONLY HETEROGENEITY WITHIN A STRAIN BUT ACROSS, YOU KNOW A SPECIES. AND WHETHER THEY MAY HELP FORM THE DEGREE OF GREATER ASPECTS OF VARIABILITY. >> THAT CAME UP ONLY BRIEFLY WHEN WE WERE DISCUSS HANDWRITING YOU SEE THERE ON THAT THEME 1. IT'S A WONDERFUL POINT. AGAIN I THINK THIS IS SOMETHING I CAN TAKE BACK TO THE GROUP FOR US TO THINK ABOUT. IT'S A GREAT POINT. >> OKAY. >> YEAH, I HAVE A QUESTION THAT PERHAPS IS AN GERMANE TO CHRISTINE'S PRESENTATION AS YOURS BUT IN OUR PORTFOLIO, I WONDER AT TIMES WE HAVE PEOPLE STUDYING EXPERIMENTAL LABORATORY PAIN IN HUMANS AND I WONDER HOW MUCH PEOPLE VIEW THESE MODELS AS TO THINK ABOUT ACUTE PAIN AS IT'S EXPERIENCED IN CLINICAL SETTINGS AND RELATED TRANSITION ISSUES. I WAS A LITTLE SURPRISED THAT DIDN'T APPEAR IN EITHER PRESENTATION. >> SO, CHRIS DO YOU WANT TO TAKE THAT 1? >> YOU KNOW QUITE FRANKLY WE HAVEN'T DISCUSSED IT. SO I WILL TAKE THAT COMMENT BACK AND ASK ABOUT IT. >> YEAHSAME WITH US. I DON'T THINK WE DISCUSSED THAT. , WE'RE REALLY THINK BEING THE CLINICAL CONDITIONS, YOU KNOW? >> IT'S AN IMPORTANT ISSUE. >> TELL BE INTERESTING TO SEE. >> THANK YOU. >> YEAH, I JUST--OFFER A COMMENT FROM INSTITUTE OF MEDICINE MEETING THAT WE HAD TO TO TRY AND ENGAGE SOME OF THE PHARMACEUTICAL INDUSTRY FOLKS AND TO MAKE A LARGE INVESTMENTS AND PAIN RESEARCH AND IT CAME DOWN TO KIND OF A SIMPLE COMMENT TAP THEY--THEY ARE LOOKING TO THE RESEARCH WORLD TO COME UP WITH THE CIRCUIT ABNORMALITY PHENOTYPES THAT TED MENTIONED, YOU KNOW IT GOES UNDER THE NAME BIOMARKER BUT IT'S REALLY SOMETHING THEY CAN THEN TARGET THEIR THERAPIES AGAINST AND KNOW THAT THEY'RE DO IN HUMANS WHAT THE PLAN WAS BASED ON THEIRANNAL EXPERIMENTS AND THE TAKE HOME POINT WAS THEY SAID AT THE END THAT, THEY DON'T REALLY NEED ANYMORE TARGETS FROM THE BASIC RESEARCH AND MAYBE THIS IS OVEREMPHASIZING OR CHARACTERIZING THEM. THEY HAVE PLENTY OF TARGETS BUT THEY DON'T--THEY'RE NOT GOING TO GO ANY FURTHER UNLESS THEY HAVE A MARKER IN THE HUMAN OF WHAT THIS TARGET IS AND THEY ENGAGE IT. SO I WOULD JUST THROW IT OUT TO THE GROUP THAT YOU KNOW THERE'S TREMENDOUS FINANCIAL BENEFIT TO THE INDUSTRY GETTING INVOLVED IN THE PAIN THERAPIES BUT UNTIL WE HAVE THAT KIND OF KNOWLEDGE THAT WE CAN APPLY TO HUMANS, I THINK--I THINK THAT THE--THAT SIDE OF THINGS IS GOING TO BE DEAD. SO I JUST SAY HOW IMPORTANT THAT IS IT TO TRY TO EMPHASIZE. >> RIGHT. THAT WAS SOMETHING THATICALLY UP A LOT. AGAIN WITH WE WERE TALKING UNDER THEME 1 MAINLY. I JUST WANT TO ADD 1 LAYER TO THAT IS WE HAD A LOT OF DISCUSSION OF WHETHER DRUGS THAT WOULD TARGET TRANSITION TO POTENTIALLY CHRONIC PAIN OR POTENTIALLY REVERSE CHRONIC PAIN MECHANISMS WOULD NEED TO TARGET THE MECHANISM THAT GOT YOU THERE OR IF YOU HAVE PRORESOLUTION MECHANISMS THAT CAN YOU TARGET BETTER INDEPENDENT OF THE MECHANISMS THAT CAUSE YOU TO TRANSITION IN THE FIRST PLACE. AND I THINK, YOU KNOW [INDISCERNIBLE] WAS A BIG PROPONENT BUT ALSO AN ANA[INDISCERNIBLE] WAS ALSO 1 WHO WORKED ON THE POSITION WHERE THE MECHANISMS YOU ACADEMY ON COULD GET YOU THERE. SO I THINK IT'S IMPORTANT WE NEED TO DO NEUROSCIENCE IN HUMANS TO DEMONSTRATE THE TARGETING ENGAGEMENT AND YOU HAVE MAYBE NOT A BIOMARKER FOR PAIN BUT A BIOMARKER OF MANIPULATING THE TARGET THAT YOU'RE GOING AFTER. SO, I THINK THAT--YOU KNOW THERE'S STILL A LOT OF OPPORTUNITY THERE--THAT ISN'T NECESSARILY ALONG THE LINES OF, YOU KNOW WE KNOW ENOUGH--WE HAVE ENOUGH TARGETS FOR WHAT'S PROMOTING CLINICS AND MAYBE THERE'S A WHOLE OTHER TARGET THAT'S EMERGE FREE RADICALS GENERATED PRECLINICAL WORK BUT WE CERTAINLY RECOGNIZE THE POINT OF THE COMMENT AND IF THERE WERE LININGS OF NEW RESEARCH THAT WE WOULD HOPE WOULD COME OUT OF OUR RECOMMENDATION, I THINK THE FOCUS WILL BE VERY HEAVY IN THAT DIRECTION. >> CAN I-- >> NOT ONLY FOR THE BENEFIT OF FARMA BUT FOR THE BENEFIT OF ALL OF US THAT ARE TRYING TO FIND NOW WAYS TO FIGURE OUT THIS PROBLEM. >> I'D LIKE TO NOW PUT ON MY BASIC SCIENCE HAT BECAUSE I'M QUITE CONCERNED WHEN I HEAR COMMENTS COMING FROM FARMA THAT WE DON'T NEED TO IDENTIFY ANY NEW TARGETS. WE HAVE PLENTY OF TARGETS, WE NEED TO BE SURE THAT THE DRUGS WE'RE DEVELOPING ARE HITTING THOSE TARGETS WITHOUT BEING OVERLY FLIP, IT'S I BIT LIKE THE BRITISH PATENT OFFICE CLOSING IN THE 18th CENTURY WHEN THEY SAID THAT EVERYTHING EVERYTHING HAD ALREADY BEEN DISCOVERED. AND I THINK IF THAT MESSAGE WERE TAKEN LITERALLY IS THAT BASIC SCIENTISTS DON'T NEED TO LOOK FOR BASIC TARGETS WE HAVE ENOUGH AND SO IT'S JUST A MATTER OF SOMEBODY FIGURING OUT A WAY TO HIT THEM AND I JUST THINK THAT'S WRONG. >> NO 1 WAS SAYING THAT'S RIGHT. >> NO I'M SAYING THAT'S WHERE WE ARE. I MEAN I THINK THAT'S A SAD STORY THAT WE HAVE TO--YOU KNOW WE HAVE TO KIND OF BREAK THAT WALL THROUGH. BUT I DON'T AGREE--I AGREE THAT WE DO NEED MORE EFFECTIVE TARGETS BUT TO GET THE INDUSTRY BACK INVOLVED AGAIN IT SEEMS AS THORS THAT'SALE REALLY WHAT THEY'RE GOING TO WANT. >> WELL, SO, YOU KNOW I THINK IT CAN ALSO BE THE CASE THAT A RERECOMMENDATION THAT COME OUT OF OUR WORKING GROUP IS THAT ACADEMIC NIH FUNDED DRUG DISCOVERY HAS A REAL CHANCE TO BE SUCCESSFUL. WE HAD THE NIH BLUEPRINT FOR DRUG DISCOVERY AT A NEUROSCIENCE EMPHASIS, I WAS A RECIPIENT OF 1 OF THOSE GRANTS AND WE HAVE CONTINUED TO RUN A FAIRLY SUCCESSFUL DRUG DISCOVERY PROGRAM AND I THINK THERE'S LOTS OF MORE STUDENTS FOR THAT. SO I DON'T THINK WE HAVE TO LOOK AT IT NECESSARILY AS DOING THIS FOR BENEFIT OF INDUSTRY TO GET THEM BACK INVOLVED. WE ACCOUNTED SAY THIS IS SOMETHING THAT THERE ARE OTHER WAYS TO GO AFTER IT. >> THANKS. WE HAVE 1 MORE QUICK QUESTION AND THEN WE SOPHISTICATED TO GO TO SEDDEN BEFORE WE LOSE HER. >> --I WOULD LIKE TO MAKE A QUICK COMMENT ABOUT LOOKING FOR A MAGIC TARGET AND A MAGIC SINGLE DRUG. I GET TO SEE A LOT OF THESE NEW TARGETS COME AND GO DURING DRUG DEVELOPMENT AND NONE OF THEM ARE VERY SPECIFIC AND THAT FALLS ON THEIR DOWN FALL. SO AS WE THINK ABOUT THE RESEARCH AND WE THINK ABOUT THE TARGETS, I THINK THAT THE ANSWER FROM A PHARMACOLOGIC PERSPECTIVE IS PROBABLY NEVER GOING TO BE SO SIMPLE AS A SINGLENTITY AGENT BUT PERHAPS A FINELY TUNED COMPIPPATION OF TARGETS THAT WILL MAXIMIZE THE MANY DIFFERENT SYSTEMS INVOLVED AS TARGETS BUT WITHOUT HAVING TO COMPLETELY ANTAGONIZE OR COMPLETELY ACTIVATE ANY 1 AND BE MORE OF A MODLATTORY PRODUCT SO THAT IT'S TOLERABLE AS WELL AS EFFECTIVE BECAUSE BY THE TIME WE FINISH BLOCKING ANY 1 TARGET FOR ACTIVATING MAXIMALLY ANY 1 TARGET WE HAVE SO MUCH NONPAIN RELATED BAGGAGE THAT THEY ARE NO LONGER VALUABLE TACKERETS. SO I--I ACTUALLY DON'T KNOW IF THAT HAS ANYTHING TO DO WITH THE PRESENTATION BUT SINCE WE'RE TALKING ABOUT THAT IN PARTICULAR, I FELT COMPELLED THAT PERHAPS THE PUSH BACK TO THAT IS A MORE SOPHISTICATED APPROACH AND LESS OF A MAJOR SINGLE MINDED APPROACH. >> THANKS SHARON. AND GOOD POINT AND THANKS VERY MUCH TED FOR THE PRESENTATION, PLEASE STAY ON IF YOU CAN. SEDDON, WE ARE HOPING YOU ARE STILL WITH US. >> I AM STILL WITH YOU, CAN YOU HEAR ME OKAY. >> PLEASE GO AHEAD. YES. >> OKAY, WONDERFUL SO I HAVE ONLY HEARD A LITTLE BIT OF WHAT CHRISTINA SAID SO FORGIVE ME IF I'M IN A VACUUM OR IN SOME WAYS REDUNDANT OR NOT RESONANT WITH WHAT OTHER PEOPLE ARE DOING. THE CHRONIC WORK PAIN GROUP HAD A PROCESS THAT MAY BE DIFFERENT THAN THE OTHERS. WE ACTUALLY STARTED OUT BY CREATING A GRID THAT SPANNED THE FIELD OF CHRONIC PAIN AS WE CO-CHAIRED AND THEN TRY TO MAKE SURE THAT WE HAD EXPERTS WHO HAD EITHER RESEARCH OR DESCENT SKILLS OR KNOWLEDGE IN THAT AREA. SO WE STARTED OUT WITH PEOPLE DESIGNATED TO PARTICULARLY DOMAINS IN THE FIELD OF CHRONIC PAIN BOTH SORT OF MECHANISMS AND TYPES OF PAIN AND TREATMENT APPROACHES FOR PAIN. AND WE ASKED EACH COMMITTEE MEMBER TO DO A LITTLE PREWORK BEFORE WE MET IN PERSON AND WE ASKED THEM TO TO SKETCH OUT CLINICAL NEEDS AND GAPS IN THEIR AREA TO LOOK AT IN THE RECENT IN THE PAST DECK ODE OR 2 KEY RESEARCH FINDINGS AND CLINICAL OBSERVATIONS, HOT TOPICS IN THAT AREA AND THEN WHAT ARE CURRENT AREAS OF ROBUST RESEARCH AND THEN THINK ABOUT WHAT ARE NEW EMERGING OR FUTURE QUESTIONS. AND SO EVERYBODY WROTE A PAGE AND THEN WE TOOK THAT INFORMATION AND MADE A CROSS WALK OF, YOU KNOW NEEDS AND GAPS AND RESEARCH FINDINGS AND ROBUST RESEARCH AND EMERGING QUESTIONS AND THEN KIND OF LOOKED AT THIS CROSS WALK FOR EMERGING THEMES AND OUT OF THE DISCUSSION OF SORT OF THE COMMONALITIES AND PRIORITY AREAS, FOR EACH OF THE DOMAIN, WE BEGAN TO GENERATE OUR RESEARCH PRIORITIES. AND I'M GOING TO SHARE THOSE WITH YOU. WE'RE CURRENTLY AT THE POINT WHERE WE HAVE MATCHED THOSE NEW PRIORITIES SLIGHTLY DIFFERENT THAN THE DOMAINS WE START WIDE, WITH A LEADER AND WE WILL MOVE ON. I THINK I NEED THE NEXT SLIDE AT THIS POINT. TO EACH LEADER SKETCHING OUT THAT PRIORITY IN A BIT MORE DEPTH, ANSWERING THE QUESTIONS YOU SEE, AND PART OF YOU HERE, THESE ARE ESSENTIALLY THE QUESTIONS THAT I THINK YOUR GROUP GENERATED AND THEN ADDED 1 CURRENT STEP OF RESEARCH IN THE AREA. SO WE SHOULD HAVE THOSE WITHIN THE NEXT 10 DAYS AND WE WILL MOVE FORWARD FROM THERE. SO BRIEFLY OUR PRIORITYINGS FELL INTO 3 AREAS. WE DIDN'T SET OUT THIS WAY, BUT WHEN WE LOOK AT WHAT WE HAD, LINDA DID YOU HAVE THE PRIORITIES ON THE SLIDE? >> OH I'M SORRY, THERE THEY ARE. >> AND, THIS MECHANISMS RELATED, TREATMENT RELATED AND SORT OF RESEARCH METHOLOGYS. SO, IN SOME OF THESE ARE VERY BROAD AND WE DO HAVE SOME SUBSTANCE TO THE RATIOS THAT CAN GO INTO IF YOU WOULD LIKE ME TO BUT FOR NOW, TO DETERMINE THE MECHANISMS THAT SUSTAIN MODULATE OR RESOLVE AND/OR RESOLVE CHRONIC PAIN AND THAT'S LOOKING AT NEUROBI OPEN LOGIC, PSYCHOLOGIC AND IMUBE O LOGIC ENDOCRINE AND MECHANISM AND DEVELOPMENTAL AND GENETIC ISSUES, AND CONSIDERING THEM AT ALL LEVELS, PERIPHERAL, SPINAL AND BRAIN. AND DAN AND AND DR. APKARIAN ARE GOING TO LEAD THAT 1. THE SECOND 1 IS TO DETERMINE RELATIONSHIP BETWEEN COMMON CHRONIC PAIN AND CO-MORBIDITIES SUCH AS BMI, FATIGUE, EMOTIONAL PSYCHOLOGICAL COGNITIVE, DYSFUNCTION, SLEEP DISFUNCTIONS AND REWARD AND REENFORCEMENT DYSFUNCTIONS AND BOB KERNS WILLED LEAD THAT 1. THERE WAS A LOT OF DISCUSSION ON THIS 1 AROUND WHETHER, THE FACT THAT CHRONIC PAIN OFTEN BEGETS SOME OF THESE CO-MORBIDITIES BUT CHRONIC PAIN CAN BE A AREY CULT OF THE CO-MORBIDITIES AND THEY CAN COEXIST. SORT OF EXAMINING THOSE CHECKEN AND EGG FACTORS. THIRD IN THE MECHANISMS WAS REALLY FOCUSED ON CHILDHOOD PAIN, NOT THE DEVELOPMENT OF CHILDHOOD PAIN OR WHICH WOULD BE MORE TRANSITIONAL OR HOW EVENTS IN CHILDHOOD CAN TRANSITION INTO CHRONIC PAIN AND ADULTHOOD BUT REALLY FOCUSING ON THE SPECIFIC MECHANISMS AND TREATMENT IN THE CONTEXT OF EXISTING CHILDHOOD CHRONIC PAIN AND HOW THEY DIFFER FROM ADULTS. TERMS OF TREATMENT, THIS IS A REALLY BROAD 1 SO I INCLUDED SOME SUBCATEGORIES. THEY FILL THE GAPS IN THE KNOWLEDGE BASE OF HOW TO SAFELY AND EFFECTIVELY TREAT AND IDEEMLY CRE CHRONIC PAIN. SO THE IDEA OF WHETHER WE USE THE PALLIATE PAIN OR WHETHER WE CAN ACTUALLY ERADICATE PAIN AND ISSUES AROSE PARTICULARLY ALONG--AROUND LONG-TERM EFFECTIVENESS KNOWING THAT MANY CONDITIONS WOULD HEAVILY THROW WITH THEM, LOOKING AT SUB-GROUP RESPONSIVENESS OF EXISTING TREATMENTS AND CONSIDERING MECHANISMS, SORT OF THINKING ABOUT OPIOIDS AND OTHER REWARD PRODUCING MEDICATIONS AND HOW CAN WE AX VOID SUCH ADVERSE EFFECTS SUCH AS MISUSE, ADDICTION AND RESPIRATORY DEPRESSION, AND THEN NOVEL BIOLOGIC TARGETS AND FARM AND NONPHARMACOLOGIC TREATMENTS AND THEN AS WITH OTHER GROUPS THINKING ABOUT EFFECTIVENESS ACROSS THE LIFE SPAN. AND RECOGNIZING THAT PARTICULARLY WITH AN AGING POPULATION, WE NEED TO LOOK AT NOT ONLY THE CHILDHOOD THINGS THAT ARE PRIOR PRIORITY FOCUSED ON BUT ALSO LOOK AT GERIATRIC ISSUE AS WELL. OR LATE LIFE ISSUE. AND THEN, MORE TREATMENT RELATED, THIS IS REALLY A NUMBER 5 IS MORE OF A SYSTEMS ISSUE. I'M NOT SURE IT COMES OVER ACROSS SO MUCH IN THE WAY THIS PRIORITY IS WRITTEN WITHOUT THE BULLETS THAT OFTEN FOLLOW IT, BUT IT'S REALLY LOOKING TO BENEFIT TO THIS AND CHRONIC PAIN TREATMENT. MULTIFACTORIAL PAIN TREATMENT, FELLOW PAIN TREATMENT AND COORDINATED PAIN TREATMENTS SO THAT WE CAN INFORM REGULATORY APPROVAL REIMBURSEMENT AND CLINICAL ISSUES TO LOOK AT SYSTEMS OF PAIN MANAGEMENT AND PARTICULAR TREATMENTS WITHIN THOSE SYSTEMS. NUMBER 6, FOCUS ON PRECISION MEDICINE APPROACHES AND IMPROVE CONNECT TREATMENT AND REDUCE RISK TARGETING TO SUBPOPULATIONS, HOW CAN WE E DENTIFY AND BEST MATCH TREATMENTS TO INDIVIDUALS. >> NUMBER 7, DETERMINING THE OPTIMAL PATHWAY GIVES RAMSTERS OF SELF-MANAGEMENT, STRATEGIES FOR CHRONIC PAIN, WHAT DOSES AND APPROACHES ARE MOST HELPFUL. AND WE HAVE 3 PEOPLE WITH GREAT [INDISCERNIBLE]. THEY'LL BE LOOKING ON THEM. NEXT AND FINAL, I THINK, THEN CONSIDERING RESEARCH APPROACHES, AND AGAIN, I THINK I HEARD ANOTHER GROUP DISCUSSING THIS WHEN I CAME ON, THE CALL ACCIDENT HOW DO WE IDENTIFY THE DOMAINS WE NEED TO MEASURE, WHAT OUTCOME MEASURES WE SHOULD USE, BIOMARKERS AND THEIR UTILITY BOTH IN ANIMAL AND HUMAN STUDIES. AND 7, THE IMPORTANCE OF HAVING LESS NATIONAL DATA SETS AND PROSPECTIVE REGISTRIES FOR CLINICAL POPULATIONS OF PATIENTS WITH CHRONIC PAIN WHO WERE TREATED SO THAT, WITH THE LARGER DATABASE, WE CAN BEGIN TO IDENTIFY SUBPOPULATIONS WHO RESPOND TO THIS CARE AND THAT'S IT. >> GREAT, THEY THINK YOU SO MUCH SNRKTS YOU'RE WELCOME. >> QUESTION? DAN? >> HI, SED,. >> I KNOW WHEN ROGER PRESENTED EARLIER, I KNOW YOU WERE NOT PRIVY TO ALL PRESENTATIONS, BUT ON DISPARITIES THEY MADE A SPECIFIC RECOMMENDATION TO SOCIOECONOMIC AND I KNOW AT SOME POINT THEY WILL GO OVER ALL THE DIFFERENT GROUPS AND MAKE SURE THEY'RE ALL CONNECTICUT CYSTENT BUT THIS MIGHT BE 1 OF THE GROUPS WHERE AN EXPLICIT REFERENCE TO SOCIOECONOMIC STATUS OR SOCIAL DETERMINANTS OF HEALTH COULD BE ADDED IN. THERE'S NOTHING INCONSISTENT WITH WHAT YOU'VE DONE, IT'S JUST A FILL-IN OR GAP, AS I'M SAYING THAT IT OCCURS TO ME SOMEWHERE IN THE DOCUMENT WHETHER IT'S DISPARITIES OR THIS SECTION, IT WOULD BE GREAT TO REPRODUCE THE ICONIC WORLD HEALTH ORGANIZATIONS NIGHINIZATION DIAGRAM OF SOCIAL DETERMINANTS OF DISEASE. BECAUSE THAT'S WHAT PEOPLE ARE DANCING AROUND. >> YES. >> THEY'VE HAD A LOT OF MONOGRAPHS, THEY HAVE A HUGE TERRIFIC LITERATURE THAT ON THAT THAT COULD BE REFERENCESSED. >> RIGHT. OKAY. THAT'S AN EXCELLENT SUGGESTION. IT'S INTERESTING THAT MY MOST REFLECTIVE THOUGHT WHEN YOU SAID THAT AS TO WHERE IT BELONGS IS IN CO MORBIDITY AND WHILE WE DON'T THINK OF GO TO ECONOMIC STATUS AS A CO MORBIDITY, IT CERTAINLY CAN CREATE SOCIAL STRESSORS THAT THEN FUNCTION TO FACILITATE THE EXPERIENCE OF CHRONIC CONDITIONS. SO I'M JUST SORT OF WONDERING WHERE YOU WOULD PLUG THAT IN AND I'M QUESTIONING MY REFLECTS BUT THAT'S JUST WHAT POPPED INTO MY MIND. >> HI, SEDDON,. >> CATHY UNDERWOOD. >> HI, CATHY. >> YOUR TREATMENT TO CHRONIC PAIN PRIORITIES HOW DO YOU SEE THAT AS DIFFERENT THAN WITH WHAT WAS DISCUSS INDEED THE NATIONAL PAIN STRATEGY? WHAT APPROACH WOULD YOU TAKE THAT'S GOING TO BE DIFFERENT THAN WHAT THE RECOMMENDATIONS WERE FOR NPS? >> I DON'T HAVE THOSE IN FRONT OF ME SO IT WOULD BE VERY HARD FOR ME TO SPEAK TO THAT. DO HAVE YOU A PROCESS? DO YOU FIND THEY'RE VERY SIMILAR? >> WELL I'M JUST--I'M THINKING THAT THE THINGS THAT YOU IDENTIFIED AS BEING RESEARCH QUESTIONS WERE THE SAME KINDS OF QUESTIONS THAT WERE ASKED IN THE NATIONAL PAIN STRATEGIC PLANEM SO I'M TRYING TO DETERMINE WHAT THE DIFFERENCE IS BETWEEN THE RECOMMENDATIONS, YOU KNOW WITH RESPECT TO PAYORS AND THINGS LIKE THAT. >> IT HAS TO--I VALID TO DO A SIDE BY SIDE. IT PROBABLY WOULD HAVE BEEN PRUDEN PROCESS FOR US TO USE THOSE IN FORMULATING OUR PRIORITIES. WE DID NOT. THEY CAME UP FROM TIME TO TIME IN CONVERSATION, BUT IT MIGHT BE USEFUL TO DO A SIDE BY SIDE AND SEE IF WE CAN DISTINGUISH THEM. >> SEE IF WE ADDED ANYTHING OR SEE IF IT'S IDENTICAL. >> SO I THINK ACTUALLY WE'VE SEEN RECOMMENDATIONS COMING UP WITH THE WORK GROUP CONVERSATIONS THAT ARE VERY MUCH ALIGNED WITH AND OVERLAP WITH THE NATIONAL PAIN STRATEGY AND WE SORT OF GENTLY POINTED THAT OUT. I ACTUALLY THINK IT'S A REALLY GOOD THING THAT THAT'S HAPPENING AND THAT THE WORK GROUPS WILL SEE THAT THEY'VE GOT MORE DETAIL AND MORE POTENTIAL APPROACHES TO ADDRESSINGHAT THEY SEE IN THE NATIONAL PAIN STRATEGY THROUGH WHAT THEY'RE DOING NOW. AND THESE 2 DOCUMENTS, THE PAIN STRATEGY AND THE RESEARCH STRATEGY WERE MEANT TO ALIGN. IF YOU REMEMBER BACK FROM THE VERY BEGINNING WE-- >> [INDISCERNIBLE]. >> AS A COMMITTEE THE BIG RESEARCH PIECE FROM THE NATIONAL PAIN STRATEGY. SO YOU KNOW I UNDERSTAND THAT THERE MIGHT BE A CONCERN IN LOOKING AT IT THAT WAY BUT I THINK WE'RE LOOKING AT IT AS COMING OUT VERY POSITIVE. >> I WASN'T REALLY EXPRESSING A CONCERN, I WAS JUST WONDERING HOW THEY WERE GOING TO COME AT IT IN A DIFFERENT WAY PERHAPS THAN WHAT HAD ALREADY BEEN DONE. >> SO THIS IS MARTHA. AS I WAS LISTENING TO ALL THESE RESEARCH GROUPS, I THINK THEY'RE FANTASTIC AND AS I WAS LISTENING TO THIS MORNING, THERE ARE SO MANY OVERLAPS AND SO MANY ONGOING THINGS AND THEN WHEN YOU READ, SORT OF THE BEGINNING OF THIS AFTERNOON OF A PREAMBLE, THERE ARE MANY THINGS FROM THE ACUTE TO THE CHRONIC TO THE SAME QUESTIONS ARE BEING ADDRESSED BUT IN A DIFFERENT WAY SO 1 WAY IS TO MAKE SURE THAT THE 1 OR 2 PEOPLE ON A WORKING GROUP THAT SIT INOT OTHER WORKING GROUP HAVE SOME WAY OF MAKING SURE WE'RE NOT DUPLICATING EFFORTS BUT ACTUALLY SYNERGIZING. >> THANKS, WE'VE ACTUALLY STARTED CO-CHAIR, CO-CHAIR CONVERSATIONS NOW. SO DEED'S GROUP, TRANSITION HAS MET WITH PREVENTION WHICH DIDN'T SIM LIKE A LIKELY OVERLAP BUT THERE WERE OVERLAPS SO WE WILL CONTINUE TO PURSUE THAT AND THEN MAYBE ALL THE CO CHAIRS AT SOME POINT WILL SIT DOWN IN THE SAME ROOM TOGETHER, TRYING TO FIGURE OUT THE FACE-TO-FACE. BUT THAT'S A GOOD POINT BECAUSE WE WANT TO MAKE SURE THIS IS, YOU KNOW IT TURNED OUT IN THEIR OVERLAP QUESTION THAT THEY WERE LOOKING AT THE SAME RESEARCH PRIORITY FROM DIFFERENT ANGLES. SO--I THINK-- >> I WANT TO MAKE 1 OTHER COMMENT WITH REGARD TO CHRONIC PAIN, IN THE WORK THAT MARK AND RICHARD DID, THAT LINDA TALKED ABOUT EARLIER,IVE I WAS JUST STRUCK BY THE 14% OF PEOPLE WHO HAVE DISABLING CHRONIC PAIN HAVE CO MORBIDITIES THAT ARE JUST UNBELIEVABLE. THEY ARE THE SICKEST PEOPLE IN THE COUNTRY AND SO THE CO-MORBIDITIES GO TO ALL SORTS OF THINGS, CANCER, HEART DISEASE, YOU KNOW SEVERE DISABLING CONDITIONS, SO, SO I JUST KIND OF LOOK AND URGE THE PEOPLE WELL, NOT BECAUSE THEY HAVE SOME OTHER MEDICAL PROBLEM. SO NOT IN YOUR FACE, OR IGNORE THE FACT THAT THEY'RE SUFFERING TREMENDOUSLY FROM CHRONIC PAIN. >> YOU KNOW THAT BRINGS UP A VERY INTERESTING ISSUE THAT I RECALL US DISCUSSING WHICH IS QUITE AMAZING ACTUALLY AND THAT IS THAT CHRONIC PAIN OF COURSE CAN EXIST FOR MANY REARS BUT WHO MAJOR GROUPS OF IT IS CHRONIC PAIN DUE TO A PERSISTING PHYSICAL PROBLEM OR A CHRONIC PHYSICAL PROBLEM SUCH AS, YOU KNOW INFLAMMATORY ARTHRITIS OR PAN KRE TINSA TITIS OR OTHER DISEASES AND THEN THERE'S CHRONIC PAIN THAT PERSISTS DESPITE APPARENT HEALING OF TISSUE INJURY. AND IT'S NOT ONLY DIVIDING BECAUSE IT'S OVERLAP IN THE GROUPS BUT YOU'RE CORRECT. SO, YOU'VE MADE THAT POINT IN BRINGING UP THIS CO MORBIDITY ASSOCIATED WITH CANCER OR OTHER SEVERE PHYSICAL CONDITIONS. >> THE ONLY OTHER POINT I WOULD MAKE IT--I'M SORRY. I APOLOGIZE, IT'S JUST ECHOING WHAT WALTER SAID. I THINK WHEN I WAS INTRODUCED TO THIS HERE, THE WHOLE EFFORT WAS TO CONVINCE OR IMP CISE AND URPD SCORE WHAT THE PROBLEM WAS SO THAT THE RESEARCH ENTITIES THAT DO FUND RESEARCH WILL LOOK AT AS SOMETHING THAT HAS TO BE DONE. THE FACT IS THAT THERE ARE AND I SAID THIS TO MANY PEOPLE, THERE'S AN AMERICAN CANCER SOCIETY AND HEART ASSOCIATION, ARTHRITIS FOUNDATION, THERE'S EVERY FOUNDATION FOR YOU NAME THE DISEASE BUT YOU CAN'T NAME 1 MAJOR PAIN FOUNDATION THAT ACTUALLY FUNDS PAIN RESEARCH AT A LEVEL TO THESE PHILANTHROPIC GROUPS AND THE ONLY RESOURCE IS THE GOVERNMENT, GOVERNMENT AGENCY AND TO A SMALL EXTENT FARMA BECAUSE THEIR OBJECTIVE IS VERY DIFFERENT. SO I THINK THAT COMMENT IS ABSOLUTELY CRITICAL. THAT'S WHAT THIS IS ALL ABOUT. >> RICARDO HAS BEEN WAITING FOR PATIENTLY. >> HI, RICARDO. >> I WAS WONDERING, WHAT DO YOU THINK ABOUT THE COMMENT RAISED BY [INDISCERNIBLE] LATELY ABOUT INCREASING SUICIDALLITY ON CHRONIC PAIN PATIENTS. HE WAS SAYING ABOUT THAT ABOUT 24,000 DEATHS WERE ATTRIBUTED TO CHRONIC PAIN LAST YEAR IN HERMS OF HOW CAN WE PRIORITIZE--TERMS OF HOW CAN WE PRIORITIZE THIS INTO OUR LIST OF CO MORBIDITY TOWARDS A SPECIFICALLY, AND SEE, WHAT IS THE CORRELATION OF THESE CHANGES THAT ARE OCCURRING IN THE WAY THAT WE ACTUALLY ARE TREATING CHRONIC PAIN LATELY. >> RICARDO I'M SORRY, I MISSED 1 WORD EARLY ON AND I THINK IT WAS A KEY WORD. >> [SPEAKING AT ONCE ] >> I WAS TALKING ABOUT SUICIDALLITYS. >> SUICIDALLITYS. >> YEAH. >> SO THAT IN THE CONTEXT OF THE IN CREASE OF CASES ATTRIBUTED TO CHRONIC PAIN IN THE LAST COUPLE OF YEARS. >> SO THAT, ARE YOU SUGGESTING-- >> [SPEAKING AT SAME TIME BEING ] >> WHAT I WAS SAYING SEDDON, IS DO YOU THINK IT WILL BE WORK PRIORITIZING THAT IN THE COMMUNITIES TRYING TO UNDERSTAND WHY THAT IS THAT PARTICULAR--WHY IS THE RACE ON SUICIDALLITY HAPPENING IN THE LAST FEW YEARS. >> YES. >> WE HAVE BEEN DOING CHANGES IN THE WAY WE PRESCRIBE FOR CHRONIC PAIN PATIENTS AND I WONDERED IF THERE IS I CORRELATION THERE? >> I THINK THAT'S A REALLY EXCELLENT POINT. I THINK THAT THAT CERTAINLY WOULD FALL UNDER CO MORBIDITY AND THAT WILL HELP DISTRESS MOOD DISORDERS BUT MAYBE IN THIS CASE, WE SHOULD ADD IN THERE OPIOID RELATED DISTRESS EXCEPT IT'S REALLY--MAYBE A--[INDISCERNIBLE] IN SENSE OF CHANGES OF PRESCRIBING NOW BUT YES, WE WILL MAKE A NOTE OF THAT AND DISCUSS WHERE THAT SHOULD GO. I THINK THAT'S REALLY IMPORTANT. >> CINDY. >> THANK YOU YOU. I THINK I WANT TO TIE WHAT ALAN JUST SAID AND RICARDO JUST SAID WHICH IS SOMETHING IMPORTANT TO NOTICE IS THAT WHILE WE MAY HAVE THESE CO-MORBIDITIES LIKE DEMOCRACY AND PAIN AND CANCER AND PAIN, IT IS THE PAIN I WOULD SUGMITT THAT IS THE THEN THAT REALLY DESTROYS PEOPLE'S LIVES. IN OTHER WORD FIST YOU TALK TO PATIENTS, THE THEY THINK MOST DISABLES THEM MAKES THEM UNABLE TO FUNCTION IS THE PAIN COMPONENT OF WHATEVER THAT ILLNESS IS AND SO, YOU KNOW, YOU OFTEN GIVE THE EXAMPLE, YOU KNOW CANCER DIAGNOSE, IT'S A TERRIBLE THING, ALTHOUGH MANY PEOPLE GO ON THROUGH THEIR TREATMENT AND CONTINUE TO FUNCTION AND WORK AND STILL CAN HAVE A LIFE. IT IS THE PAIN PIECE OF THIS THAT STARTS OUT AND DESTROYS THEIR LIFE AND MAKES THEM UNABLE TO PER TIS PARTICIPATE IN A TRIAL, HAVE A SOCIAL LIFE, UNABLE TO WORK, LEADS TO ICYALATION, IS THE MOST PREVALENT THING THAT--TO A PATIENT AND SO PUTTING THOSE THINGS TOGETHER I THINK IS REALLY ACCIDENT REALLY IMPORTANT. THE PAIN PIECES--OH, YOU HAVE PAIN. THE PAIN IS FUNDAMENTALLY THE THING THAT DESTROYS PEOPLES LIVES. >> JUST TO ADD WHAT SHE SAID, WE JUST DID A SURF A ON ACCESS TO CERTAIN PEOPLE AND 1 THING WAS THAT THEY COULDN'T GET THEIR MEDICATION TO HELP WITH THEIR PAIN AND 43% THOUGHT THEY WOULD CONSIDER SUICIDE O IT IS A BIG ISSUE. 43% THAT'S HUGE OUT OF A THOUSAND PEOPLE. AND IT IS THE PAIN AND IT'S THE FEAR OF THE PAIN BECAUSE THEY DON'T KNOW WHAT THEY'RE GOING TO DO IF THEY CAN'T CONTROL THE PAIN. >> RIGHT. >> SO I THINK THAT-- >> I BEING THE LAST FEW MINUTES OF DISCUSSION CAN TAKE US BACK INTO TRYING TO UNDERSTAND WHY ANIMAL MODEL WHICH PARING [INDISCERNIBLE] CLINIC BECAUSE WE CAN'T [INDISCERNIBLE] COMPLEXITY OF EFFECT IN AN ANIMAL AND I THINK IT'S 1 EVER THE THINGS THIS COMMITTEE CAN LOOK INTO IS TRY TO DEFINE CORRECTLY THE PRECLINICAL MODEL IN PAIN RESULTINGS. OR IS IT TO JUSTIFY IT TO USE IT THAT THE PATHOPHYSIOLOGY AND THE FIELD WILL COME UP WITH BETTER MOLECULAR TARGET, IT IS--IS IT LIKELY TO EVER BE USED TO PREDICT WHICH DRUGS WILL WORK IN A CLINIC BECAUSE THAT AS HUGE IMPLICATION FOR THE FUNDING AND LAST MANY DECADES, IT IS DIFFICULT TO COME UP AS MANY ANIMAL MODELS THAT WILL USE TO CORRECTLY PREDICT WHAT WILL HAPPEN IN A CRIPPIC. >> JAN AND THEN I THINK WE WILL MOVE ON. >> SO HEARING SYND SCHEPENNY MAKES ME RECALL THAT THERE WERE HUNDREDS OF PATIENT TESTIMONIES GALGTERRED IN THE IOM PROCESS AND 1 OF THE KEY THEMES THAT PATIENTS VOICED WAS STIGMA. AND I HAVEN'T SEEN THE WORD STIGMA MERE, EVERYTHING HERE IS FINE, BUT WHEN WE'RE TALKING ABOUT OUTCOME MEASURES, WE'RE LOOKING AT MENTAL HEALTH ASSESSMENT, LET'S FUNCTIONALITY ASSESSMENT BUT THERE'S AN ELEMENT OF HOW THE PATIENT WITH PAIN IS TREATED BY THOSE SURROUNDING THAT PATIENT OR SOCIETY, AND THE WORD THAT COMES UP AGAIN AND AGAIN IS STIGMA. THERE'S LARGE LITERATURE ON THE STIGMA. SO SOMEWHERE IN THIS, AS I SAID IN YOUR TRAINING AND PSYCHIATRY, OR YOUR FAMILIARITY WITH IT, WOULD PLACE THIS, WOULD CONTEXTUALIZE THIS BUT THAT WOULD ALSO HELP BUILD BRIDGES TO PATIENTS AND PATIENT ADVOCATES BECAUSE THEY HAVE TO LIVE WITH STIGMA. >> THANKS DAN, THANKS SO MUCH FOR JOINING US, I KNOW YOU'RE INCREDIBLE LIE BUSY TODAY WITH ANOTHER MEETING. >> YEAH. >> SO WE HAD HALF AN HOUR SORT OF AT THE END OF ALL THE PRESENTATIONS FOR DISCUSSION BUT WE'VE KIND OF DONE THAT THROUGH EXPANDING THE PRESENTATIONS SO IF IT'S OKAY WITH EVERYBODY I'LL SORT OF CONSIDER THAT WE'VE GONE THROUGH THAT PHASE, ALREADY. OKAY. AND THEN I HAD A FEW MINUTES TO SUM UP THE NEXT STEPS AND AGAIN WE'VE TALKED ABOUT A LOT OF THIS, SO THE 1 MINUTE OVERVIEW OF WHERE WE GO FROM HERE IS THAT, YOU KNOW CLEARLY WHAT YOU'VE SEEN FROM THE GROUPS, THEY'RE SO--THEY'VE SHOULD SO MANY INTERESTING CONVERSATIONS. THEY'VE GOT THEIR HIGH LEVEL PRIORITIES IDENTIFIED AT THIS POINT. SOME OF THE GROUPS WANT TO PRIORITIZE, SOME OF THEM ARE VERY ANXIOUS ABOUT LOADING WHAT THEY THINK ARE AN ENTIRE SET OF VERY, VERY IMPORTANT PRIORITIES SOPHISTICATEDY WE HAVE WORK OUT THOSE DETAILS A LITTLE BIT. OUR PROMOTIONAL NEXT, NEXT STEP IS TO BRING THE CO CHAIRS TOGETHER FROM ACROSS THE GROUPS. INITIALLY WE THOUGHT WE WOULD DO 1 BIG CO-CHAIR MEETING AND THEN WE'RE STARTING TO THINK THAT CO CHAIR TO COCHAIR AND CO CHAIR WILL OVERLAP BEFORE WE PUT THE ENTIRE GROUP TOGETHER AND THEN WE WOULD MOVE TO SOME KIND OF A MEETING OF ALL THE CO CHAIRS TO MAKE SURE THAT ALL THESE OVERLAP ISSUES AND MERGER ISSUES ARE SOMEWHAT WORKED OUT. SO THAT'S BEGINNING AND THEN THERE'S THE ISSUE OF PRIORITIZEERATION ACROSS ALL THE GROUPS AND HOW WE DO THAT AND HOW MANY ULTIMATE GOAL MAYLY WE WANT TO END UP WITH AND I DON'T THINK ANYBODY QUITE YET HAS A REALLY GOOD IDEA OF WHAT EYE GOOD NUMBER IS BUT 1 OF THE WAYS TO GET THERE IS TO MAKE SURE THAT THESE ARE REALLY DEFINED AND EVERYBODY'S HAPPY WITH THE WAY THEY ARE SET BEFORE THEY SUBMIT THEM TO THE FULL GROUP AND A PEATS OF THAT IS CONSISTENCY AND PRESENTATION. SO WE HAD SOME SUGGESTIONS FROM THE STEERING COMMITTEE ABOUT HOW TO FORMAT A TEMPLATE OF EACH OF THE GROUPS WOULD PUT THEIR RESEARCH PRIORITY IT IS FORWARD SO THEY CAN ACTUALLY COMPARE THEM BETTER ACROSS THE GROUPS. THEY'VE ALL TAKEN A BIT OF AN APPROACH AND MAKE SURE YOUR PRIORIES ARE IF THERE'S RESEARCH QUESTIONS, THE SAMPLE YOU HAD ON THE ACUTE PAPE GROUP, SORT OF AS HOW THEY WOULD PRESENT AN OVERVIEW, WE'VE BEEN COLLECTING ISSUES AS THEY COME UP IN THE GROUPS AS SOMETHING THAT SHOULD BELONG IN THE PREAMBLE IN THE ENTIRE DOCUMENT AND I THINK THE IDEA THAT JOSIE BROUGHT FORWARD FOR A MATE RICK TO PUT TOGETHER. SO THERE'S A BIT OF REFINEMENT TO DO BUT I THINK WE'RE GETTING CLOSE TO THE END. THE OTHER PIECE THAT CAME UP IN CONVERSATION IS IF WE GET A SET OF PRIORITIES FROM THE ENTIRE GROUP, AND IF A HANDFUL KIND OF FALLS TO THE BOTTOM, DO WE WANT TO HOLD ON TO THOSE AND PUT THEM TO AN APPENDIX SO THAT THE AGENCY THAT PLIGHT WANT TO FUND SOMETHING THAT THEY WERE ALREADY WORKING ON OR THEY THOUGHT WAS PARTICULARLY IMPORTANT TO THEIR MISSION, WOULDN'T GET SORT OF LOST IN THE PRIORITIZATION PROCESS. OKAY. GOOD AND THEN ULTIMATELY, THE STEERING COMMITTEE WILL HAVE ANOTHER UPDATE OR SO, AND THEN FINAL DOCUMENT WILL HAVE TO GO THRU THE STEERING COMMITTEE AND THE IPRCC BEFORE IT'S RELEASED TO THE AGENCIES TO CONSIDER FOR FUNDING. SO I WOULD LIKE TO PROPOSE THAT RATHER THAT KNOW WE COME BACK AT 3:35, WE HAVE 2 MORE PRESENTATIONS NOTOT RESEARCH STRATEGY BUT ON SOME OTHER THINGS YOU FIND REALLY IMPORTANT THAT WE TAKE A SHORTER BREAK AND COME BACK AT 3:25 PERHAPS AND LET--AND LET--BOTH OF OUR SPEAKERS HERE AND THEN WE CAN GET EVERYBODY OUT A BIT EARLIER, THE CAFETERIA IS CLOSED ANYWAY. THE COVERY SHOP AND THE MACHINE. 3:25 WE WILL START THEN. >> THANK YOU SO MUCH SEDDON. CAPTIONS RESUME SHORTLY >> HOPEFULLY THE RESEARCH WE FUND WILL ULTIMATE GOAL MITT LE GO ON TO INFORM THE DEVELOPMENT OF GUIDELINES, POLICY AND CLINICAL POLICIES. SO WE ARE REALLY FOCUSED ON 2 SPECIFIC QUESTIONS, ANSWERING 2 SPECIFIC QUESTIONS. WHAT CARE IS BETTER, FOR INDIVIDUAL PATIENT? AND HOW CAN PATIENT-CENTERED CARE BE BETTER AND WE'RE FOUNDED ON ABOUT 5 NATIONAL RESEARCH PRIORITIES THAT WERE IDENTIFIED EARLY IN OUR EXISTENCE. JUST TO LET YOU KNOW, I GUESS SINCE SOME PEOPLE DON'T UNDERSTAND WHAT PC ORI IS, WE ARE A NONPROFIT, NONGOVERNMENTAL ORGANIZATIONS 92YATION THAT WAS CREATED UNDER THE AFFORD AMILLIO CARE ACT AND ALL OF OUR MONEY COMES FROM A CRUST FUND THAT WAS SET UP AND WE GET $650 MILLION A YEAR TO FUND RESEARCH. BUT WE'RE NOT A GOVERNMENT AGENCY EMPLOY WE SIT OUTSIDE OF THAT. WE WERE REQUESTED TO SET NATIONAL PRIORITIES EARLY ON AND THEY WERE VERY BROAD PRIORITIES FOCUSING ON A COMPARATIVE CLINICAL EFFECTIVENESS RESEARCH AND TRADITIONAL DRUG-DRUG COMPARISONS, DEVICES SURGICAL PROCEDURES, IMPROVING HAIR, HEALTH SYSTEMS, LOOKING AT HOW WE CAN IMPROVE CARE DELIVERY AND ALSO ADDRESSING DISPARITIES WHICH IS A FUNDAMENTAL FOCUS, I THINK OF THIS PARTICULAR COMMISSION. ONE WE HAVE GOODA EVIDENCE WE'RE INTERESTED IN RESEARCH IN HOW DO WE SPEED THAT INTO IMPLEMENTATION AND PRACTICE. SOPHISTICATEDY WE FUND DISSEMINATION RESEARCH AS WELL. ALL OF OUR ORGANIZATION IS BUILTOT FOUNDATION OF SOLID METHODS AND ARE BUST METHODS SO WE'RE ADVANCING METHODS IN COMPARATIVE EFFECTIVENESS RESEARCH AND JUST TO LET PEOPLE KNOW, I'M NOT GOING TO TALK A LOT ABOUT THIS, BUT WE ARE ACTUALLY FUNDING SOME ADVANCES IN PROMISE MEASURES RELATED TO PAIN AND IF YOU WANT MORE ON THAT, I CAN GIVE THAT TO YOU LATER. WE DO HAVE PAIN RESEARCH IN ALL OF THESE BASIC AREAS THAT YOU SEE HERE. AND OUR ULTIMATE GOAL IS REALLY TO IMPROVE PATIENT CENTERED OUTCOMES. SO WE HAVE A HEALTHY BUT NOT REALLY DEEP PORTFOLIO IN PAIN AND IN OPIOID USE. AND AS OF OCTOBER 2016 WE FUNDED 45 MOG ECTOMYOSINS TO THE TUNE OF ABOUT $136 MILLION. IN NONCANCKER CHRONIC PAIN MANAGEMENT OR OPIOID USE, WE ALSO HAVE A HANDFUL OF PROJECTS WE FUNDED IN ACUTE PAIN. I THOUGHT IT WOULD BE A LITTLE BIT MORE ILLUMINATING FOR YOU IF I WENT THROUGH AND TALKED ABOUT SOME SPECIFIC EXAMPLES OF PROJECTS THAT WE HAVE FUNDED AND DECIDED THE BEST WAY TO DO THIS WAS TO APPROACH IT THROUGH THE MAJOR FUNDING VEHICLES WE HAVE. WE HAVE 3 MAJOR FUNDING VEHICLES, 1 IS BROAD FUNDING ANNOUNCEMENT WHICH IS OUR TRADITIONAL INVESTIGATOR INITIATED STUDIES AND THAT FOCUSES ON STUDIES UP TO 2-$5 MILLION. THAT CAN SPAN UP TO 3-5 YEARS DEPENDING ON UPON THE NATIONAL PRIORITY AREA THAT IT'S ADDRESSING. WE ALSO HAVE THE PRAGMATIC CLINICAL STUDIES FUNDING ANNOUNCEMENT THAT'S BEEN IN EXISTENCE SENT 2014 AND THE IDEA BEHIND THIS IS THAT WE WANT TO FUND LARGER MORE IMPACTFUL STUDIES OF NATIONAL SIGNIFICANCE REALLY FOCUSED ON HIGH PRIORITY AREAS IDENTIFIED BY ORIGINAL STAKEHOLDERS. AND FINALLY WE HAVE SOMETHING CALLED A TARGETED FUNDING ANNOUNCEMENT, WHICH REALLY TARGETS 1 PARTICULAR DISEASE AREA OR TOPIC, VERY SPECIFIC TOPIC, MAY HAVE SEVERAL MULTIPLE RESEARCH QUESTIONS EMBEDDED WITHIN THAT. AND FUNDING WILL DEPENDOT FUBBING ANNOUNCEMENT AND BUT TO GIVE AN EXAMPLE, 1 IS ON CHRONIC LOW SPECIFIC BACK PAIN AND WE'RE OBLIGATING UP TO $22 MILLION TO ANSWER 1 RESEARCH QUESTION AND 1 STUDY. THESE TOPICS ARE CHOSEN THROUGH BROAD STAKEHOLDER PROCESS. SOME OF YOU MAY HAVE ATTEND SAID SOME OF OUR LARGE EXPERT PANEL MEETINGS AND ADVISORY MEETINGS WE HAVE IN ORDER TO HELP REFINE THESE TOPICS. SO LET'S START FIRST WITH BROAD FUNDING ANNOUNCEMENT. I WANT TO TALK ABOUT THIS STUDY HERE WHICH IS ACTUALLY--SHE'S AN INVESTIGATOR THAT I OVER SEE OF THIS PROJECT. CYNTHIA CAMPBELL OUT OF KAISER PERMANENT OF NORTHERN CALIFORNIA. AND HER STUDY IS FOCUSING SPECIFICALLY ON PATIENT ACTIVATION SESSIONS, TARGETED TOWARDS PEOPLE WHO ARE USING OPIOIDS LONG-TERM. THE GOALS ARE TO IMPROVE PATIENT'S ABILITY TO MANAGE THEIR OWN PAIN AND IT'S A LARGE PRAGMATIC STUDY LOOKING AT METHODS USING 480 PATIENTS APPROXIMATELY AND SEVERAL DIFFERENT PRACTICES WITHIN THE KAISER PERMANENT SYSTEM. THIS GIVES YOU A REALLY GOOD SENSE OF THE KIND OF RESEARCH, VERY PATIENT FOCUSED, THE INTERVENTION WAS IN CONJUNCTION WITH STAKEHOLDERS, IN ADDITION THE OUTCOMES THAT ARE BEING MEASURED ARE VERY PATIENT-FOCUSED, WE'RE LOOKING AT PATIENT ACTIVATION, PATIENT ENGAGEMENT, PATIENT SATISFACTION, AS AS FUNCTIONING AND MANAGEMENT OF PAIN, SO THESE WERE ALL THINGS THAT WERE IDENTIFIED AS VERY IMPORTANT TO THE PATIENTS. IN ADDITION THEY'RE LOOKING AT HEALTH SYSTEMS USES AND REDUCTIONS IN OPIOID USE. OUR RAGMATIC CLINICAL STUDIES FUNDING ANNOUNCEMENT AS I MENTIONED BEFORE FOCUSES ON PRIORITY, HIGH PRIORITY AREAS OF NATIONAL SIGNIFICANCE AND WE HAVE APPROXIMATELY 25 HIGH PRIORITY TOPICS AND IN ADDITION, ON THAT LIST, OF HIGH PRIORITY TOPICS IN OUR FUNDING STUDIES ANNOUNCEMENT THERE ARE 3 THAT ARE SPECIFICALLY RELATED TO PAIN. ONE IS LOOKING AT SYMPTOMATIC OFTIO ARTHRITIS, THE OTHER IS TREATMENT OF MIGRAINE AND FINALLY LOOKING AT PHARMACIST OR A NURSE-LED INTERVENTIONS OR HEALTH I.T. SOLUTIONS TO HELP ENHANCE PRIMARY CARE PHYSICIAN MANAGEMENT OF CHRONIC NONCONSER PAIN. WE RECENTLY MADE AN AWARD IN THIS AREA TARGETING 1 OF THOSE HIGH PRIORITY AREAS. THIS WAS A MADE TO OOJ SWEAT. IT'S A 7 MILLION-DOLLAR STUDY THAT SPANS 5 YEARS, A LITTLE OVER 5 YEARS. IT'S A LARGE PRAGMATIC STUDY TARGETING ABOUT 1300 PATIENTS AND IT'S GOING TO BE TAKING PLACE IN A WIDE, DIVERSE CLINIC SETTING, RANGING FROM HEADACHE SPECIALTY CLINICS, GENERAL NEUROLOGY CLINICS, COMMUNITY BASED NEUROLOGY CLINICS AND PRIMARY CARE CLINICS. AND THIS IS TARGETING A VERY IMPORTANT PROBLEM IN THE AREA OF MIGRAINE RESEARCH OF OVERUSE OF MEDICATION. AND THIS COMPARING 2 DIFFERENT STRATEGY OF ARE IN WIDE SPREAD USE BUT WE DON'T UNDERSTAND WHICH WORKS BETTER SO 1 IS EARLY DISCONTINUATION OF MIGRATION--OF OVER USE MEDICATION BECAUSE PROPHYLACTIC THERAPY VERSUS MIGRAINE PROPHYLACTIC THERAPY WITHOUT EARLY DISCONTINUATION, THIS AGAIN IS AN EXAMPLE OF KIND OF THE HALLMARK OF WORK THAT WE FUND AT PC ORI, THESE ARE STRATEGIES THAT ARE COMMONLY USED BUT WE REALLY DON'T KNOW WHICH 1 WORKS BETTER THAN THE AND OTHER THAT'S THE PURPOSE OF THE RESEARCH IS TO BE ABLE TO LOOK AT THAT. ANOTHER HALLMARK OF THE RESEARCH THAT WE FUND IS THAT WE HAVE DEEP ENGAGEMENT BY PATIENTS AND OTHER STAKEHOLDERS FROM THE BEGINNING ALL THE WAY THROUGH TO THE END AND HERE YOU CAN SEE THE AMERICAN HEADACHE AND MIRROR IMAGE GRANT ASSOCIATION, AMERICAN HEADACHE SOCIETY AND ALLIANCE FOR HEADACHE DISORDERS, ADVOCACY ARE DEEPLY INVOLVED IN THIS PROJECT. FINALLY, I WANT TO TALK ABOUT OUR TARGETED FUNDING ANNOUNCEMENT AND LINDA HAD ACTUALLY ASKED ME TO SPEND A BIT MORE TIME IN THIS AREA, THIS IS AN AREA WHERE WE'RE DEDICATING QUITE A BIT OF MONEY. WE HAVE 3 MAJOR TARGETED FUNDING ANNOUNCE WANTS IN THE AREA OF PAIN AND WE HAVE OBLIGATED OVER $90 MILLION TO ADDRESS THESE PARTICULAR ISSUES. ONE IS LOOKING AT THE TREATMENT STRATEGIES FOR MANAGING AND REDUCING LONG-TERM OPIOID TREATMENT FOR CHRONIC PAIN. WE JUST RECENTLY MADE 2 AWARDS IN THAT PARTICULAR AREA. AND OBLIGATED $21 MILLION FOR THOSE 2 STUDIES. WE ALSO HAVE 1 THAT'S LOOKING AT AS I MENTIONED BEFORE, SURGICAL AND NONSURGICAL OPTIONS FOR MANAGEMENT OF NONSPECIFIC CHRONIC LOW BACK PAIN. AND THAT 1 IS UP TO $22 MILLION. WE'RE CURRENTLY REVIEWING APPLICATIONS. THE FINAL 1 IS REALLY LINKED VERY MUCH TO THE EARLIER 1 THAT WE HAD ON LOOKING AT CHRONIC OPIOID THERAPY BUT WE'RE LOOKING FURTHER UPSTREAM TO PEOPLE WHO ARE EITHER POTENTIAL NEW USERS OF OPIOIDS OR WHO HAVE BEEN ON OPIOIDS FOR LESS THAN 3 MONTHS. AND LOOKING AT STRATEGIES TO PREVENT UNSAFE OPIOID PRESCRIBING IN THIS POPULATION. NOTEDDABLY AS PART OF THIS NIEPT MILLION DOLLARS THAT WAS TARGETED TOWARDS THESE TARGETED FUNDING ANNOUNCEMENTS, WE HAVE DEDECIDED TO REISSUE THE TARGETED FUNDING ANNOUNCEMENT ON TREATMENT STRATEGIES FOR LONG-TERM AND OPIOID TREATMENT FOR CHRONIC PAIN. AND THAT JUST RECENTLY WAS OPENED AGAIN AND WE'RE OBLIGATING UP THE 19 MILLION DOLLARS FOR THAT PARTICULAR STUDY. AND AS WE SPEAK, WE MAY KNOW IT NOW,URE BOARD OF GOVERNORS IS MEETING AND THEY ARE CONSIDERING REISSUING OUR LOW BACK PAIN 1 AS WELL. SO WE ARE TRYING TO FEED THE RATE IN WHICH WE GET THESE FUNDING ANNOUNCEMENTS OUT AND PARTICULARLY THIS IS ADDRESSING WHAT WE FEEL ARE REALLY HIGH PRIORITY AREAS OF HIGH NATIONAL SIGNIFICANCE AND NEED AND SO HOPING THAT WE CAN JUST FOLLOW 1 AFTER THE OTHER AND TRY TO REALLY FUND SOME HIGH-IMPACTFUL RESEARCH. I THOUGHT IT WOULD BE HELPFUL TO GO THROW SOME OF THE QUESTIONS THAT WERE ADDRESSED BY EACH OF THESE TARGETED FUNDING ANNOUNCEMENTS. THE 1 THAT'S LOOKING ON LONG-TERM OPIOID USE, IS LOOKING AT STRATEGIES FOR REDUCING OR ELIMINATING OPIOID USE OR POTENTIALLY STRATEGIES TO LIMIT DOSE ES CALATION. SO BOTH OF THOSE QUESTIONS WOULD BE SOMETHING THAT WE WOULD FUND IN THIS AREA. AS THINK AS WE DO FOCUS ON THE PATIENT AND THE PATIENT IS THE CENTER OF ALL THE RESEARCH THAT WE DO. IT'S IMPORTANT TO NOTE THAT THE STRATEGIES THAT WE WANT TO EVALUATE HERE MUST MANAGE PATIENT PAIN FIRST. WHILE ALSO REDUCING RISKS AND HARMS OF LONG-TERM OPIOID USE. SO WE'RE REALLY PUTTING PATIENTS AT THE CENTER OF THIS. THE LOW BACK PAIN STUDY THAT WE'RE LOOKING AT IS VERY, VERY SPECIFIC. IT'S LOOKING AT NONSURGICAL OPTIONS FOR THE MANAGEMENT OF CHRONIC NONSPECIFIC LOW BACK PAIN SPECIFICALLY COMPARING LUMBAR FUSION SURGERY VERSUS OPTIMIZED NONSURGICAL COMPREHENSVE MULTIDISCIPLINARY PAIN PROGRAM FOR CHRONIC NONSPECIFIC LOW BACK PAIN. AND I NOTED AS PART OF THE NATIONAL PAIN STRATEGY DOING MORE RESEARCH IN THIS PARTICULAR AREA IS 1 OF THE PRIORITY AREAS AND SO, THIS ALSO IS CLOSELY LINKED TO THE NATIONAL PAIN STRATEGY. AGAIN BOTH OF THESE ARE EVIDENCE BASED BUT THEY HAVEN'T BEEN COMPARED WELL, HEAD-TO-HEAD AND WE ARE FUNDING A VERY LARGE TRIAL WITH THE IDEA THAT POTENTIALLY WE CAN DRILL DOWN MORE INTO WHAT ARE THE SPECIFIC CLINICAL AND PATIENT CHARACTERISTICS THAT RESPOND WITH BETTER SUCCESS IN 1 OF THESE VERSUS THE OTHER LOOKING AT HETEROGENEITY OF TREATMENT EFFECTS. WE ARE ALSO VERY INTERESTED LOOKING AT DURABILITY OF OUTCOMES SO WE'RE REQUESTING THE 2 YEAR FOLLOW UP FOR THIS STUDY. THE SAFE OPIOID PRESCRIBING INITIATIVE IS LOOKING AT BOTH PAYOR OR HEALTH SYSTEMS STRATEGIES, THAT THAT USE POTENTIAL LE COMPLEX MULTICOMPONENT INTERVENTIONS TO ADDRESS NONPRESCRIBING OF OPIOIDS FOR PAIN MANAGEMENT AS WELL AS POTENTIALLY IMPROVING THE PATIENT FUNCTION AND QUALITY OF LIFE FOR MANAGING PAIN WITHIN THIS POPULATION. AND THE OTHER QUESTION IS, LOOKING AT DIFFERENT PATIENT AND PRACTICES VIEDER PATIENT INTERVENTIONS THAT FACILITATE AND IMPROVE KNOWLEDGE, COMMUNICATION AND/OR SHARED DECISION MAKING AND I NOTE AGAIN THAT EVEN THOUGH WE MAY HAVE EFFECTIVE STRATEGIES OUT THERE THAT OFTEN TIMES THE PATIENTS AREN'T AWARE OF THOSE, SOMETIMES THE PHYSICIANS ARE NOT AWARE OF THOSE AND THIS IS AN IMPORTANT FOCUS OF OURS. AGAIN, THE FOCUS IS NOT JUST ON CHANGING PRESCRIBING DEHAIR BUT WE WANT TO MAKE SURE THESE STRATEGIES NOT ONLY MAINTAIN BUT IMPROVE THE QUALITY OF PAIN MANAGEMENT. AND I WAS TALKING TO PEOPLE AT LUNCH THAT IN FACT WE'RE REQUIRING FOR THIS PARTICULAR FUNDING ANNOUNCEMENT THAT PEOPLE COME IN IF THEY'RE A HEALTH SYSTEM, TEEMING WITH THE HEALTH SYSTEM, AND TEAMING WITH THE PAYOR THAT THEY PROVIDE COVERAGE FOR ALTERNATIVES TO OPIOIDS SOPHISTICATEDY WE'RE REALLY PUSHING THAT AGENDA. THIS IS AN EXAMPLE OF 1 OF THE STUDIES WE HAVE FUNDED ALREADY UNDER THIS TARGETED FUNDING ANNOUNCEMENT, THIS WAS IN MANAGEMENT OF PEOPLE ON LONG-TERM OPIOID THERAPY. THIS IS A STUDY THAT IS BEING LED BY AARON KREBS ON UTR OF THE UNIVERSITY OF PHILADELPHIA, ASSOCIATE WIDE THE VA THERE. IT IS A PARTICULAR STUDY, HEALTH SYSTEM STUDY AND IT'S LOOKING AT 2 STRATEGIES THAT DIFFER SUBSTANTIALLY IN TERMS OF THEIR RESOURCE INTENSITY. SO 1 OF THEM IS LOOKING AT INTERDISCIPLINARY PAIN MANAGEMENT TEAM EMPHASIZING NONPHARMACOLOGICAL ALTERNATIVE. WHICH IS USED AS BY THE VA BUT PROVEN EFFECTIVE WITHIN THE VA BUT NOT VERY WELL ADOPTED OUTSIDE OF INTEGRATED HEALTH SYSTEMS. SO THE COMPARAT TORHERE IS COLLABORATIVE MEDICATION MANAGEMENT LED BY A CLINICAL PHARM CYST THAT'S USING STEP THERAPY. THE IDEA IS THAT POTENTIALLY THIS LOWER RESOURCE STRATEGY IF IT DOES PROVE TO BE AS EFFECTERRIVE COULD BE SOMETHING THAT COULD BE TAKEN UP OUTSIDE IN A LESS INTEGRATED HEALTHCARE SYSTEM. THIS IS A LARGE RANDOMIZED PRAGMATIC TRIAL OF 1400 PRIMARY CARE PATIENTS AT 9 DIFFERENT V. A. SITES. SO I DO THINK WE FILL A RATHER UNIQUE NICHE IN TERMS OF THE FUNDING THAT WE SUPPORT, WE--OUR FOCUS ON PATIENT CENTERED OUTCOMES, ALSO ARE FOCUSED ON COMPARATIVE CLINICAL EFFECTIVENESS RESEARCH IS SOMEWHAT UNIQUE COMPARED TO OUR SISTER--I CALL THEM SISTER AGENCIES BUT WE'RE NOT A FEDERAL AGENCY. AND ALSO OUR FOCUS AND REQUIREMENT THAT PATIENT AND STAKEHOLDER ENGAMEMENT OCCUR AT THE BEGINNING, THE INCEPTION OF THE STUDY, ALL THE WAY THROUGH IMPLEMENTATION AND THROUGH TO COMMUNICATION. WE SEQ TO COMPLEMENT AND NOT DUPLICATE ONGOING NEDERAL RESEARCH, I'VE SPENT A LOT OF TIME ON THE PHONE WITH SEVERAL OF THE PEOPLE HERE IN THE ROOM, TRYING TO MAKE SURE THAT THE ISSUES THAT WE HAVE BEEN FUNDING ARE COMPLIMENTARY TO WHAT'S ALREADY BEING PLANNED AND JUST TO NOTE, WE DON'T HAVE ANYTHING CURRENTLY IN THE AREA OF PAIN BUT WE DO HAVE COLLABORATIVE STUDIES WITH OTHER FEDERAL AGENCIES AND THAT'S AN IMPORTANT PART OF YOUR STRATEGY TOO SO WE'RE COLLABORATING FOR EXAMPLE WITH NION FALSE PREVENTION. WE HAVE COMPLIMENTARY COLLABORATIVE RESEARCH WITHIN NHLBI ON HYPER TENSION AND WE HAVE WORK WITH AHRQ AS WELL AS CDC. SO I'M HOPING HAVE YOU A LITTLE BIT BETTER UNDERSTANDING OF PC ORI AND THE TYPE OF WORK THAT WE FUND. THANK YOU. I'LL TAKE QUESTIONS. >> THANKS SO MUCH, YOU CAN APPRECIATE IT. QUESTIONS? >> ALL RIGHT, WELL, AGAIN IT WAS VERY INFORMATIVE PRESENTATION, PENNY REALLY APPRECIATE IT. IT'S GOOD TO KEEP UP WITH YOUR FOCUS IS DIFFERENT FROM OURS BUT WE OVERLAP, GREAT. WE HEARD THAT TODAY. >> ALL RIGHT, AND-- >> ALL RIGHT, SO, OUR LAST INVITED SPEAKER FOR TODAY IS JONI, FROM NIDA, WILL TALK TO US ABOUT THE PRECISION MEDICINE INITIATIVE. >> [INDISCERNIBLE] >> YEAH, THANK YOU. >> AND WHILE YOU'RE DOING THAT, I WANT TO THANK THE GROUP FOR THE INVITATION AND I SHOULD CORRECT WALTER I'M ACTUALLY NOT FROM NIDA, ANYMORE, ALTHOUGH I MISS IT. I WAS ASTERISKS NIDA, I WAS DIRECTOR OF NEUROSCIENCE AND BEHAVIORIAL RESEARCH AND I AM CURRENTLY IN THE OFFICE OF THE DIRECTOR WORKING WITHIN THE ALL OF US RESEARCH PROGRAM. I WILL TELL YOU A LITTLE BIT ABOUT THAT TODAY. GREAT, THANK YOU SO MUCH. SO MY TITLE IS HERE AT THE BOTTOM, IT'S--I'M THE DIRECTOR THE PROGRAMS AND STRATEGIC IMPLEMENTATION WHERE RIGHT NOW, A VERY SMALL OFFICE AND WE HOPE TO BE EXPAND HAPPENING SOON BECAUSE THERE'S WORK THAT HAS TO GET DONE. WHOOPS. >> AND I--I ALTS WANT TO SAY HAPPY HALLOWEEN. SO I WILL TRY TO GET YOU OUT EARLY. THE ALL OF US RESEARCH PROGRAM WAS FORMERLY CALLED THE PRECISION MEDICINE INITIATIVE COHORT PROGRAM. AND OVER TIME, THERE HAVE BEEN A LOT OF COMPLAINTS ABOUT THE USE OF THE WORD COHORT ESPECIALLY. SO WE HAVE GONE THROUGH A PROCESS OF SORT OF REBRANDING OUR NAME AND I WILL TELL YOU ABOUT HOW THAT CAME ABOUT. SO WHERE THE ALL OF US RESEARCH PROGRAM WHERE THE FUTURE OF MEDICINE BEGENERATEDS WITH YOU AND HERE AGAIN I WILL SAY THAT EACH THOUGH THIS S&P OUR TAG LINE THAT WE'RE USING, THE FUTURE OF MEDICINE ACTUALLY BEGAN WITH GOASY WHO REALLY STARTED THIS PROJECT AND WAS--IS A REFLECTION OF HER BRAIN, HER SENSIBILITIES AND HER ENTHUSIASM FOR THIS AREA OF RESEARCH AND I HOPE YOU'LL SEE SOME OF HER FINGERINTS ON THIS THROUGHOUT. SO THANK YOU, JOSIE. >> OKAY, SO, ALL OF US IS THE FUTURE OF HEALTH BEGINS WITH YOU, THIS IS PART OF THE PRECISION MEDICINE INITIATIVE. THIS WAS JUST UNVEILED A COUPLE OF WEEKS AGO ON OCTOBER 13th AND IT'S AGAIN, BASED ON FEEDBACK FROM THE COMMUNITY GROUPS AND POTENTIAL PARTIC PACTS WHO REALLY HATED THE TERM COHORT SO WE LISTEN TO THAT AND WE WANTED TO MAKE SURE WE INCORPORATE THAT INFORMATION. THE ALL OF US IS ABOUT ALL OF US. IT'S ABOUT A PRIORITY TO ACHIEVE DIVERSITY OF PARTICIPATION AND RESEARCH AND THAT NEEDS TO BE ALL OF US. AND IT'S ALSO ABOUT ALL OF US HAVING ACCESS TO DATA AND KNOWLEDGE FROM THIS PROGRAM. THIS IS ABOUT SORT OF GENERATING A NEW WAY OF DOING RESEARCH WITH ABOUT HAD--WHAT WE'RE HOPING TO BE UPWARDS OF $320 MILLION IN THE FUTURE AND SO, WHAT I LIKE ALSO ABOUT THIS BRAND IS THAT YOU HAVE TO SAY THE WORDS. IT'S NOT--IT'S NOT AN ACRONYM. SO YOU HAVE TO SAY ALL OF US. SO THERE YOU ARE. THAT'S ALL OF US. SO, WHAT ARE WE DOING? WE ARE BUILDING 1 MILLION OR MORE VOLUNTEERS REFLECTING BROAD DIVERSITY OF THE UNITED STATES POPULATION. THERE WILL BE OPPORTUNITIES FOR ANYONE AND EVERYONE TO RAISE THEIR HAND AND PARTICIPATE IN THIS PROGRAM AND THEY WILL BE ABLE TO PARTICIPATE ON AN ONGOING BASIS, OVER THE PERIOD OF TIME THAT THIS IS GOING ON, WHICH WE HOPE IS AT LEAST 10 YEARS AND MANY MORE. THERE WILL BE OPPORTUNITIES FOR RESEARCHERS FROM A WIDE VARIETY OF BACKGROUNDS AND EXPERTISE PARTICIPANTS THEMSELVES, CITIZEN SCIENTISTS, ACADEMIC, PHARMACEUTICAL INDUSTRIES AND YOU NAME IT, WE WANT TO MAKE THE DATA AVAILABLE TO EVERYONE TO ACCESS. AND FINALLY, THIS IS NOT REALLY A STUDY ON ANY 1 DISEASE, THIS IS ABOUT BUILDING A RESOURCE TO INFORM MANY DIFFERENT TYPES OF RESEARCH STUDIES THAT CAN GO ON AND EFFECT DIFFERENT HEALTH CONDITIONS. AND THOSE HEALTH CONDITIONS WILL INCLUDE PAIN AND CHRONIC PAIN AND SUBSTANCE ABUSE AND SO, I'M NOT GOING TO REALLY FOCUS ON ANY 1 THING IN SPECIFIC, BUT I AM GOING TO GIVE YOU A LITTLE BIT OF HOW WE'RE THINKING ABOUT BUILDING IN THOSE RESEARCH PLATFORMS TOWARDS THE END. SO WITHIN THIS ALL OF US RESEARCH PROGRAM, WE HAVE REALLY TRIED TO ADLEER TO WHAT WE CALL OUR CORE VALUES FOR THE PROGRAM. THESE ARE MEANT TO REFLECT THAT PARTICIPATION IS OPEN TO ANYONE WHO'S INTERESTED IN PARTICIPATING TO REFLECT THE DIVERSITY OF THE UNITED STATES POPULATION, THAT PARTICIPANTS ARE OUR PART FERS IN ALL PHASES OF THE PROGRAM. THAT THEY WILL HAVE ACCESS TO STUDY INFORMATION AND DATA ABOUT THEMSELVES, AND THAT THAT DATA CAN BE ACCESSED BROADLY FOR A VARIETY OF RESEARCH PURPOSES AND THAT WE WILL ADHERE HERE TO THE PRIVACY AND TRUST PRINCIPLES AND SECURITY FRAMEWORK THAT THE WHITE HOUSE SET FORTH FOR THIS PROGRAM AND THAT THIS RESOURCE WILL BE A CATALYST FOR FURTHER RESEARCH AS WE DEVELOP THE PROGRAMS, RESEARCH PROGRAMS AS WELL AS INFORMING POLICIES, MOVING FORWARD. SO IN A GENERAL SENSE, ONCE THE PROGRAM IS BUILT AND I SHOULD SAY THAT WE HAVE NOT STARTED ENROLLING PARTICIPANTS YET. SO THIS IS ALL SORT OF PRIOR TO ENROLLMENT. AND IN A GENERAL SENSE ONCE WE START TO HAVE THE PROGRAM BUILT AND START TO ENROLL PARTICIPANTS, WHAT WE'LL DO IS ENABLE DIFFERENT QUESTIONS, DIFFERENT PROBLEMS AND HYPOTHESIS FOR INVESTIGATORS TO ASK THESE TYPES OF RESEARCH QUESTIONS, WE WILL CAPTURE THE DATA IN A SECURE FASHION AND IN A HARMONIZED WAY AND SHARE OR MAKE THAT DATA SHAREABLE, AND THEN WE PROVIDE THOSE DATA TO A VARIETY OF RESEARCHERS, ACROSS DIFFERENT BACKGROUNDS AND THEN ENCOURAGE THAT KNOWLEDGE, GENERATION AND TRANSLATING INTO ACTION. AND SO THAT'S JUST GOING TO BE A CYCLICICAL PROCESS THAT WE HOPE WILL ENDURE OVER TIME BUT TO DO THIS, IT'S NOT JUST BUILDING AND THEY WILL COME, IT'S ABOUT UNDERSTANDING WHAT PEOPLE'S NEEDS ARE AND BUILDING THAT INTO THE PROGRAM AND INTO THE DATA THAT WE'RE COLLECTING SOPHISTICATEDY THAT PEOPLE ARE INTERESTED IN USING THAT. AND THAT'S AN IMPORTANT ASPECT AGAIN ABOUT HOW WE THINK ABOUT WHAT THOSE QUESTIONS ARE AND WHAT PEOPLE'S NEEDS ARE AND AGAIN I'LL GET TO NAA LITTLE BIT TOWARDS THE END. >> SO IT'S EASY TO TALK A BIT ABOUT CORE VALUES AND EASY TO TALK ABOUT BUILDING TRUST AND PRIVACY INTO SOMETHING LIKE THIS. AND UNLESS YOU CAN BUILD THAT IN THIS SOME WAY THEN IT'S MUCH HARDER TO EARN THAT TRUST FOR THE PARTICIPANTS OF WHOM YOU WANT TO VOLUNTEER IN THAT PROGRAM. SO I WANT TO SPEND A BIT OF TIME TELLING YOU HOW WE TALK WITH PARTICIPANTS OR POTENTIAL PARTICIPANTS AND HOW WE DESEEN AND BUILD THE PROGRAM. SO WHAT WE'VE DONE IS WE HAVE STARTED AND WORK THROUGH DIFFERENT COMMUNITY ENGAGEMENT STUDIOS WHICH IS ABOUT BRINGING DIVERSE POPULATIONS IN A ROOM, INDIVIDUAL, DIVERSE POPULATIONS IN A ROOM, UNDERSTANDING WHAT THEIR WANTS AND NEEDS ARE FOR THE PROGRAM, FEARS, CONCERNS, THIS IS ON 60 TO DATE, WE'VE DONE 60 DIFFERENT AND THAT IS LOW, WE HAVE DONE 80 DIFFERENT INTERVIEWS AND CONDUCTED BY COMMUNICATIONS FIRM AND WE HAVE ESTABLISHED THIS SORT OF PROCESS IN WHICH WE'RE ASKING THEM ABOUT ENROLLMENT, CONSENT, WEB SITE AND DESEEN OF THE WEB SITE AND ALL OF THAT BECOMES REALLY IMPORTANT AND SO WE GET THE INFORMATION ON THESE THINGS AND THEN WE WENT BEYOND THAT TO DEVELOPING PERSONAS AND PERSONAS IS A TERM USED BY COMMUNICATIONS ABOUT COMMUNICATING AND ENGAGING WITH PEOPLE IN A WAY THAT GOES BEYOND THESE INDEPENDENT DIVERSE BODIES THAT WE BROUGHT TO ENGAGEMENT STUDIOS, IT GOES TOWARDS UNDERSTANDING PEOPLE'S BEHAVIORS AND PEOPLE'S ATTITUDES AND THEIR GOALS AND AND SO WHAT THESE PERSONAS DO IS THEN WE USE THEM TO REALLY INFORM HOW WE BUILD THE CONTENT AND MATERIALS FOR ENGAGING A VARIETY OF DIFFERENT PEOPLE AND WE LEARNED THAT--I THINK I WAS GOING TO FIND A MOUSE. WE ARE ON WEBEX, RIGHT? WE TALKED TO INDIVIDUALS WHO ARE PEOPLE, AND THERE PERSONA IS COMMUNITY AWARENESS AND THEY'RE INTERESTED IN, YOU KNOW IT MAY NOT NECESSARILY BE ABOUT ME BUT IT MIGHT BE MORE ABOUT KID ASKS PIE GRANDKIDS AND THATTA WHY I MIGHT THINK ABOUT PARTICIPATING AND THEN THERE ARE PEOPLE WHO ARE CURIOUS ABOUT BUT THEY'RE NOT READY TO DIVE IN JUST YET, BUT THEY WANT TO KNOW MORE ABOUT WHAT THE PROGRAM IS DOING AND THEN THERE'S SOMEBODY ON THE FENCE, HOW DO WE PROTECT PEOPLE AND AM I SURE THAT MY DATA WILL BE PROTECTED AND PART OF THIS IS UNDERSTANDING WHAT THE WORRIES ARE AND THE WANTS NEEDS SO THAT WE CAN TALK THROUGH THOSE ISSUES WITH VARIOUS PEOPLE AND ALSO START TO BUILD THOSE CHARACTERIICS INTO OUR DATA AND TO OUR PROGRAM. SO THIS IS HOW REBUILD THIS INTO THE PROGRAM LIKE THIS. AGAIN PARTICIPANTS ARE PARTNERS, THEY'RE NOT PATIENTS AND NOT SUBJECTS IN RESEARCH, AND WE WANT TO MAKE SURE THEY'RE INVOLVED IN EVERY STEP OF THE PROGRAM THEY LET US KNOW OR HELP US WITH WHAT KINDS OF DATA WE SHOULD COLLECT AND WHAT LAB ANALYSIS ARE OF INTEREST AND WHAT MIGHT BE CONDUCTED AND HOW DATA GETTINGS RETURNED AND WE'RE HEARING FROM THIS BECAUSE IT'S PART OF OUR GOVERNANCE STRUCTURE AND THEN WE ALSO--WE'RE EVEN HAVING THEM READ OUR PROTOCOL THAT WE'RE SUBMITTING TO THE IRB. AND THEN THERE ARE MEETINGS, TEAM MEETINGS AND THINGS LIKE THAT. IT'S BEEN CHALLENGING AND EXTRAORDINARY HELPFUL BUT IMPORTANT. THIS PROGRAM IS AGAIN ABOUT DIVERSITY AND THE NEED TO REFLECT THE UNITED STATES DIVERSITY IN A VERY MEANINGFUL WAY SO WE LIKE TO REFER TO THIS AS THE QUADRUPLE DIVERSITY WHERE YOU HAVE NOT ONLY THE PEOPLE DIVERSE IT'D BUT RACE, ETHNICITY, EDUCATION, INCOME, ALL THAT DIVERSITY BUT YOU ALSO HAVE THE HEALTH DATA DIVERSITY, PEOPLE FROM ALL WALKS OF LIFE AND HAVE A VARIETY OF DIFFERENT HEALTH OUTCOMES AND WHO ARE ALSO VERY HEALTHY. WE'RE ALSO COLLECTING A DIVERSITY OF DATA TYPES AND I'LL TALK ABOUT THAT IN A MOMENT AND OF COURSE, GEOGRAPHY AND OUR PARTNERS IN TERMS OF THE PEOPLE WHO ARE ENROLLING ACROSS THE PARTY REPRESENT THE DIVERSITY ACROSS THE UNITED STATES AND TERRITORIES. SO THIS IS THE--ESSENTIALLY WHAT OUR SORT OF 4 PILLARS OF THE PROGRAM IS TODAY. AND THIS IS I SHOULD SAY NOT REAL LOAMACYY AN NIH STUDY, WE LIKE TO THINK OF IT AS REALLY A PROGRAM THAT IS BASED ON THE RELIABLE AND TRUSTED FOUNDATION THAT HAS ACCESS TO DATA TO RESOURCES TO TOOLS AND PROCESSES THAT WILL ENABLE AND CELEBRATE A VARIETY OF RESEARCH TO HAPPEN OVER TIME SO WE HAVE A DATA AND RESEARCH SUPPORT CENTER ON THE UPPER LEFT-HAND SIDE CALLED THE DRC THAT'S WHERE ALL OF OUR DATA WILL RESIDE, WE HAVE A BIOBANK WHEN IS LOCATED AT THE CLINIC WHICH WOULD HAVE 35 MILLION VILES OF SAMPLES BY THE TIME WE'RE ALL SAID AND DONE. WE HAVE PARPARTICIPANT TECHNOLOGY CENTER, WHICH ANYTHING TO DO WITH THE PARTIC PAPT SO THE PARTICIPANT PORTAL, SMART PHONE ACCESS IS AND PARTICIPANT PROVIDED INFORMATION AND THINGS LIKE THAT ANDEN THIS WE ENROLLMENT CENTERS OR THE PHOs OR ENROLLMENT CENTERS THEY ARE THERE 3 DIFFERENT FLAVORS, THERE ARE REGIONAL CENTERS WHICH ARE ACADEMIC ORGANIZATIONS AND ALSO OUR--INTEGRATED DELIVERY NETWORKS, WE HAVE COMMUNITY HEALTH CENTERS, LARGELY RIGHT NOW THROUGH FEDERALLY QUALIFIED HEALTH CENTERS AND THEN WE ARE WORK WITH THE V. A. AS PARTNERS AND WE WILL BE WORKING WITH THEIR MILLION VETERANS PROGRAMS AND THE ENROLLMENT SITE THERE, FOR ALSO BRINGING ON ENROLLEES FROM THE V. A. SO, SO FAR THIS IS SORT OF THE LOOK AND FEEL OF THE REAL 4 PILLARS OF THE PROGRAM. THIS IS JUST A MAP--GOSH, CAN YOU SEE THIS--THIS IS A MAP OF THE U.S. IN WHERE THOSE CENTERS ARE SO WE'RE SCATTERED THROUGHOUT THE U.S. AND WE'RE ACTUALLY STILL GROWING. >> SO RIGHT NOW WE'RE PREPARING FOR WHAT WE CALL VERSION 1 LAUNCH. WE'RE AT THE STAGE OF FINALIZING THE PROTOCOL WHICH INCLUDES CONSENT LANGUAGE AND THE INITIAL SET OF QUESTIONNAIRES, AS WELL AS OUR PROTOCOLS FOR THE PHYSICAL EVALUATION AND BIOSPECIMEN COLLECTION. WE'RE CONDUCTING WEBINARS AND WORKSHOPS ENGAGING THE COMMUNITY FOR ADDITIONAL OUTREACH. WE'RE TESTING ENROLLMENT WEB SITE THROUGH THE REGULAR DESKTOP PORTAL AS WELL AS THROUGH SMART PHONES AND WE'RE TESTING THE DATA CENTER INFRASTRUCTURE TO MAKE SURE IT COMES IN AND IT LOOKS THE WAY IT LEFT AT 1 PLACE AND ARRIVING AT OTHERS, AND ALSO MAKING SURE THEY'RE SECURE SO WE'RE USING THE FED RAMP FISMA MODERAL LEVEL SECURITY TO MAKE SURE THAT'S IN PLACE. WE'RE ALSO CREATING A BIOBANK OF 35 MILLION VILES AND THEN, THROUGH ALL OF THIS, GETTING FEEDBACK PILOT STUDY WHICH GATHERED 5000 POTENTIAL PARTIC PACTS WORK THROUGH SOME OF THESE QUESTIONS AND PROBLEMS. SO THAT'S THE PROGRAM IN A NUT SHELL BUT WHAT DOES IT MEAN TO YOU. WHAT IF YOU WANT TO PARTICIPATE IN THIS PROGRAM. MEN AND WOMEN WOULD YOU HAVE TO DO SO THESE ARE THE STEPS YOU VALID TO GO THROUGH TO PARTICIPATE IN THIS PROGRAM, YOU COMPLETE QUESTIONS ON A VARIETY OF TOPICS AND I WILL SHOW YOU THOSE IN A MOMENT BUT HERE ARE A FEW, SLEEP, DIET, PHYSICAL ACTIVITY, AND HEALTH CARE ACCESS AND THINGS LIKE THAT. WE WILL CONSIDER YOU TO BE RECONTACTED AND CONSIDER TO SHARE YOUR ELECTRONIC HEALTH RECORDS. YOU WILL UNDERGO A BASE LINE PHYSICAL EVALUATION AND I'LL SHOW YOU WHAT THAT MIGHT LOOK LIKE. YOU WILL PROVIDE BLOOD AND URINE SPECIMENS AND BE WILLING TO SHARE DATA TO MAKE THE PROGRAM BETTER. YOU WILL BE WILLING TO PROVIDE DATA FROM WEARABLE DEVICES FROM YOUR SMART MOANS OR ONLINE TYPES OF GAMES. WE WILL EXPLORE ENVIRONMENTAL INFLUENCE ON THEIR HEALTH RECORDS MAYBE FROM WHERE THEY'RE FROM IN TERMS OF BEON CODED INFORMATION. THEY CAN INDUCE THE SCIENCE RELATED ACTIVITY OR IF THEY'RE INTERESTED IN THEIR OPENING REMARKS INFORMATION THAT'S FINE. THEY CAN ALSO OPT NOT TO RECEIVE ANY INFORMATION OR HAVE ACCESS TO ANY OF THEIR INFORMATION. --SO OVERTIME, WE THINK THE DATA TYPES WILL GROW AND EVOLVE AND AS WE LEARN MORE ABOUT THE WANTS AND NEEDINGS OF BOTH RESEARCHERS AND PARTICIPANTS, WE WILL BE ABLE TO MAKE SURE WE CAN COVER A VARIETY OF ASPECTS THAT ARE OF INTEREST TO PEOPLE. AND BASICALLY YOU HAVE ENROLLMENT, THROUGH THE THAT CENTER WE'RE DEVELOPING THE PORTAL THROUGH A COMPUTER OR SMART PHONE AND WE'LL HAVE A CALL CENTER AND ONCE YOU GO THROUGH THAT PROCESS, YOU MIGHT LEARN THAT YOU'RE A DIRECT AND PART OF AN ORGANIZATION BY ENROLLMENT YOU'LL BE SHUTTLED TO 1 PLACE OR THE OTHER DEPENDING ON WHERE YOU ARE. THROUGH THE DIRECT VOLUNTEERS THERE WILL BE A VARIETY OF DIFFERENT CLINICS WORKING WITH WALL GREENS FOR EXAMPLE, WILL BE A CLINIC SITE, AND--PARTICIPANTS WHO WERE IN THOSE ORGANIZATIONS WILL WORK THROUGH THOSE PARTICULAR SITES. SO FOR THE PARTICIPANT PROVIDED INFORMATION WE ARE ASKING PARTICIPANTS TO FILL OUT SURVEYS WITH THEMSELVES THIS WILL BE THROUGH A SMART PHONE OR COMPUTER SO LARGELY A DIGITAL ENTERPRISE, BUT THAT'S NOT THE ONLY OPTION, THIS IS LARGELY THROUGH A DIGITAL ENTERPRISE AND WILL ASK ABOUT THESE THINGS ON THE LEFT, THE EARLY 1S THAT WILL BE REVIEWED AND TALKING ABOUT PERSONAL HEALTH HABITS WHICH INCLUDE SUBSTANCE ABUSE AND ALCOHOL USE, OVERALL HEALTH INCLUDING MENTAL HEALTH, SOCIOLOGICAL DEMOGRAPHICS, SLEEP AND ACCESS TO HEALTHCARE AND THEN ON THE RIGHT HAND SIDE, THESE ARE THE PARTICIPANT PROVIDED INFORMATION THAT ARE UNDER DEVELOPMENT AND YOU'LL SEE THERE IS 1 HERE ON PAIN THAT WE'RE WORKING THROUGH SO THERE'S A VARIETY OF DIFFERENT MODULES THAT WE'RE DEVELOPING AND I THINK THAT OVER TIME THESE ARE THINGS--THESE ARE SORT OF THE LOW HANGING FRUIT TYPES OF INFORMATION THAT WE WILL WORK WITH OUR SISTER AGENCIES ACROSS THE NIH, AND OUR PARTICIPANTS TO UNDERSTAND WHAT KINDS OF INFORMATION THAT WE CAN ROLL INTO THESE TYPES OF PARTICIPANT PROVIEDMANNED INFORMATION FEEDBACK, AND HELP GROW THAT DATA SET. YOU KNOW IT'S IMPORTANT FOR A LONG-TERM STUDY TO MAKE IT FUN AND ENGAGING OF DOING THIS TYPE OF LONGITUDINAL RESEARCH AND SO WHAT WE WOULD LIKE TO DO WITH THE PARTICIPANT INFORMATION IS ALSO MAKE SURE THAT WE MAKE IT FUN, WE MAKE IT INTERESTING AND ENGAGING SO THESE ARE JUST SCREEN SHOTS THESE ARE SCREEN SHOTS FROM A MOBILE PHONE. SO IF YOU LOOK AT THE LEFT, YOU'RE ANSWERING A QUESTION PERHAPS ON MENTAL HEALTH. SO YOU LOOK THROUGH THE QUESTION THAT YOU RESPOND TO AND CAN YOU SEE HOW YOU COMPARE TO OTHERS IN YOUR AGE CATEGORY FOR EXAMPLE. SO YOU GET IMMEDIATE FEEDBACK TO HOW YOU COMPARE ACROSS THE PROGRAMS. SO THIS IS JUST A VARIETY OF WAYS WE CAN VISUALIZE THAT INFORMATION IN REALTIME AS PEOPLE ARE FILLING OUT THESE PARTICIPANT APPLICANT INFORMATIONS. SO IF YOU DON'T HAVE A SMART PHONE OR A COMPUTER THAT'S OKAY. WE ARE PREPARED FOR PENCIL BASED METHODS. NOT IN THE ORIGINAL LAUNCH BUT PROBABLY A FEW MONTHS LATESSER BECAUSE IT'S SO MUCH MORE INTENSE IVIN TERMS OF MAN POWER BUT WE HAVE A PROCESS IN PLACE FOR DOING THAT. THERE'S ONLY 1 PERSON IN THIS PICTURE WHO DOESN'T HAVE A SMART PHONE SO IF YOU FIGURE IT OUT, YOU WIN BUT SHE'S RIGHT HERE AND SHE LOOKS THE HAPPIEST TO ME. SO, ANYWAY. THE POINT IS, I WANT TO MAKE SURE THAT AS TIME GOES ON, PEOPLE ARE GOING TO BECOME MORE DIGITAL BUT RIGHT NOW THAT'S NOT THE CASE. WE WANT TO MAKE SURE WE TRY TO TRAVERSE THE DIGITAL DIVIDE AS MUCH AS POSSIBLE. SO THIS IS JUST A DRAFT OF THE PHYSICAL EVALUATION AND SPECIMEN COLLECTION SO YOU GET A SENSE ABOUT WHAT WE'RE COLLECTING THROUGH THE PHYSICAL EVOLUNTEERSUATION. BLOOD PRESSURE, BMI, HEART RATE, HIP SER CUM FERENCE, WAIST CIRCUMFERENCE AND WEIGHT. AND 6 TUBES OF PLOD TO MIC SURE WE HAVE ENOUGH DNA TO GO,A ROUND AS WELL AS A VARIETY OF DIFFERENT TYPES OF PLASMA AND ANALIGHTS FOR FUTURE RESEARCH STUDIES AND THEN URINE AS WELL. THIS I HOPE--I MAY NOT HAVE THE ABILITY, BUT THIS IS PRESIDENT OBAMA, HE HAS TALKED ABOUT A PARTICULAR SYSTEM IN ELECTRONIC HEALTH RECORD, SOMETHING CALLED SINK FOR SCIENCE, WE WILL BE WORKING THE INVESTIGATION 5 FOR THE COMMON MODEL WHAT THAT MEAN SYSTEM THAT WE WILL BE ABLE TO CAPTURE INFORMATION FROM A VARIETY OF DIFFERENT SOURCES AND HARMONIZE THOSE INTO 1 COMMON DATA MODEL. HAVE INFORMATION FROM THOSE SOURCES THAT WILL ENCLOUD THINGS LIKE DIAGNOSIS, LAB ANALYSIS, LAB COATS, MEDICATION HISTORY, USE, ET CETERA AND BY USING THE VERSION 5, WE WILL BE ABLE TO HARMONIZE THAT WITH NOT JUST THE EHR VENDORS AT DIFFERENT SITINGS BUT ALSO THROUGH THE CLAIMS DATA. SO IT'S REALLY IMPORTANT THAT THAT THAT TYPE OF INFORMATION IS GOING TO BE ACCESSIBLE TO ALL PEOPLE WHO VOLUNTEER FOR THIS PROGRAM. NOW FOR THE HPOs IT WILL BE FAIRLY TRAIT FORWARD OR AT LEAST MORE STRAIGHT FORWARD THAN IT IS FOR THE DIRECT VOLUNTEERS. RIGHT NOW WE DON'T HAVE A GREAT WAY OF GETTING YOUR ELECTRONIC HEALTH RECORD DATA. SOME OF YOU MIGHT TALK TO YOUR PHYSICIAN, THEY COULD GIVE YOU A PDF FILE OF YOUR ELECTRONIC HEALTH RECORD AND THAT'S GOING TO BE VERY DIFFICULT TO GO THROUGH. SO, WHAT PRESIDENT OBAMA HERE IS ACTUALLY TALKING ABOUT IN THIS VIDEO IS ABOUT PROGRAM CALLED SINK FOR SCIENCE WHICH IS REALLY ABOUT FOR THE DIRECT VOLUNTEER, APPROACH DEVELOPING A SORT OF PATIENT INITIATED WAY AND A PATIENT INITIATED APP ON YOUR PHONE THAT LEVERAGES THE SORT OF INDUSTRY ADOPTED TECHNOLOGY TO ACTUALLY GATHER AND CAPTURE THE PATIENT'S HEALTHCARE PROVIDER, THROUGH THEIR PATIENT PORTAL AND GATHER THAT INFORMATION AND SO THIS IS WHAT WE CALL SYNCH FOR SCIENCE. WE EXPECT TO PILOT THIS PROGRAM IN THE BEGINNING OF THE NEW YEAR. AND IT'LL TAKE A BIT LONGER, PROBABLY A YEAR OR YEAR AND HALF OR 2 YEARS BEFORE IT REALLY GETS UP AND RUNNING. AND SO THIS IS A WORK IN PROGRESS. JUST A QUICK WORD ABOUT DATA ACCESS, WE WANT TO MAKE SURE DATA WILL BE SHARE INDEED A RELATIVELY QUICK WAY, THIS A LONGITUDINAL PROGRAM. DATA WILL CHANGE DAILY SOPHISTICATEDY WE WANT TO MAKE SURE THAT WE PROVIDE THAT TO INDIVIDUAL WHO IS ARE INTERESTED IN SEEING IT IN A FAIRLY STRAIGHT FORWARD WAY AND ALSO PARTICIPANT 12 ACCESS TO THE STUDY INFORMATION AND THE DATA ABOUT THEMSELVES. SO THAT MEANS WE NEED TO BE VERY CAREFUL ABOUT PRIVACY AND SECURITY AND MAKING SURE WE ADHERE TO THOSE STANDARDS WITHIN THAT. AND THEN THE PROGRAM IS REALLY WANTING TO LEVEL THE PLAYING FIELD, NOT JUST FOR RESEARCH ORGANIZATIONS BUT FOR ANYONE WHO WANTS ACCESS, SO THIS DIAGRAM IS A VISUAL, BECAUSE THE DATA IS AT THE CENTER AND IT'S MEANT TO BE PROTECTED AND IN MODEL, THE PEOPLE COME TO THE DATA RATHER THAN THE DATA GOING TO THE PEOPLE SO YOU MIGHT BE FAMILIAR WITH OTHER DATABASES WHERE YOU CAN GO THERE AND DOWNLOAD DATA AND DO RESEARCH ON IT. THIS IS YOU WILL GO TO THE DATA AND LEVERAGE THINGS LIKE GOOGLE ANALYTICS TO N TOOLS THAT RESEARCHERS PROVIDED AND ANALYZE THE DATA WITHIN THAT DATA ONCLAVE. THIS IS WHAT I TALKED ABOUT BUT A MUCH NICER PATIENTS IN THE CLINIC UPPER THAT DEPICTS IT AND IT TALKS ABOUT ALL OF THE HUMAN SUBJECTS PROTECTIONS THAT WE HAVE IN PLACE FOR EACH PART OF IT. BUT'RE SO THE PARTICIPANT IS ON THE UPPER LEFT-HAND SIDE. WORKING THROUGH THE PARTICIPANT PORTAL AND THE SUPPORT CENTER, THEY ARE EITHER AN HPO OR DIRECT VOLUNTEER. THEY PROVIDE THEIR SYNCH FOR SCIENCE ELECTRONIC HEALTH RECORD, PHYSICAL EVALUATION AND BLOOD SPECIMEN GOOD TO OUR BIOBANK AND THEN THE DATA GO TO THE DATA RESEARCH CENTER. AND THEN PROVIDED THROUGH THE RESEARCH ENVIRONMENT WORKING THROUGH THE ENCLAVE HERE AS DENOTED BY THIS ACCESS CONTROL HERE. BUT THERE WILL ALSO BE A PUBLIC FACING SITE WHERE YOU DON'T HAVE TO GET ACCESS THROUGH THE DATA THAT ARE NOT GOING TO BE IDENTIFIABLE FOR EXAMPLE. AND THEN FINALLY ABOUT THE RESEARCH. SO, THIS IS ALSO ABOUT BUILDING A FRAMEWORK FOOTWORK RESEARCH AND RHYMES AND SO FORTH SO I'VE TALKED ABOUT THE OVERARCHING TYPES OF INFORMATION THAT WILL BE COLLECTED BUT WE ALSO WANT TO MAKE SURE THAT WE WILL HAVE INFORMATION THAT IS USEFUL TO RESEARCH COMMUNITIES SO WHAT WE'VE TALKED ABOUT IS SORT OF RATHER THAN HAPPENING BEING EACH OF THE ICs AND THE NIH INSTITUTES AND CENTERS FOR EXAMPLE, IS THINKING ABOUT WHAT ARE THE SCIENTIFIC BODIES OF KNOWLEDGE THAT ARE REALLY IMPORTANT THAT HAVE TENTACLES INTO EVERY INSTITUTE BUT MIGHT BE A LITTLE BIT MORE GENERAL AS WELL, SO THINKING ABOUT THIS, WE'RE TALKING ABOUT THIS AS BEING BODIES OF KNOWLEDGE. SO YOU CAN THINK ABOUT INFECTIOUS DISEASE, NEUROCOGNITIVE ISSUES, MENTAL HEALTH AND ADDICTION, HEART AND LUNG ISSUES, MOVEMENT, MUSK LO SKELETAL ISSUES, METABOLIC CONDITIONS, CANCER AND CHRONIC PAIN. WHEN WHEN YOU THINK ABOUT ALL THESE TYPES THINGS THEY CUT ACROSS SO MANY DIFFERENT TYPES OF HEALTH OUTCOMES AND THEN CROSSING THAT, AND UNDERSTANDING SORT OF WHAT ARELET PREVENTION AND WELLNESS, WHAT ARE THE ASPECTS OF CARE GIVING HOW DO WE REDUCE DISPARITIES AND IMPROVE ACCESS AND WHAT ARE THE GENOMICS INFORMATION THAT WE CAN LEARN ACROSS THE BOARD. ENVIRONMENTAL EXPOSURES AND MENTAL HEALTH AND SO USING THESE DIFFERENT THINGS ACROSS THESE PLATFORMS IN WHICH WE WILL HAVE WAYS TO REALLY TRY TO GROW THOSE BODYINGS OF KNOWLEDGE IN A MATRIX KIND OF APPROACH, AND THEN WHAT WE ENVISION IS THAT WE WILL ITERATE ON WHAT WE ARE DOING, AND SO, I TALK TO YOU ABOUT THE BASE LINE STUDY, BUT WE EXPECT THAT THERE WILL BE A VARIETY OF DIFFERENT STUDIES OR VERSIONS GOING FORWARD AND SO, THAT WILL JUST BE SORT OF A VERSIONED ASPECT OF WHAT DATA WOULD BE AVAILABLE TO PEOPLE DOWN THE ROAD SO THAT'S THE IDEA OF WHAT WE'RE THINK BEING IN TERPS OF RESEARCH QUESTIONS AND ENGAGING RESEARCH INVESTIGATORS INTO WHAT MIGHT BE OF INTEREST TO THEM THAT WE CAN THEN MAKE SURE WE BUILD THE REQUIREMENTS INTO THE SYSTEM. SO THIS IS THE ALL OF US RESEARCH PROGRAM. IT'S A NEW PLATFORM, AS A MODEL FOR RESEARCH AND IT'S BASED ON COLLABORATION AMONG RESEARCHERS PARTICIPANTS AND PROVIDERS EXPWH USING UNIQUE AND NEW WAYS. IT'S ABOUT INCREASING KNOWLEDGE AND THAT HELP US LEARN ABOUT INDIVIDUALIZED CARE AND IMPROVE THE HEALTH FOR FUTURE GENERATIONS. AND TO DO ALL OF THIS, TELL TAKE A LOT OF TIME AND WE'RE GOING TO LEARN ALONG THE WAY, THIS HASN'T BEEN DONE BEFORE. AND WE'LL MAKE A FEW MISTAKES I'M SURE BUT AS LONG AS WE LEARN FROM THEM, I THINK IT'S OKAY. SO WE DOLL THIS WITH A LOT OF FOCUS AND A LOT OF PATIENTS AS WE MOVE FORWARD BUT I APPRECIATE THE TIME TO COME AND TALK TO BUT THIS, BECAUSE I DO THINK CHRONIC PAIN, PAIN PROBLEMS IN GENERAL ARE VERY IMPORTANT AND THEY EFFECT A WIDE VARIETY OF PEOPLE SO UNDERSTANDING HOW WE CAN IMPROVE THE TYPES OF INFORMATION WE COLLECT TO THIS PROGRAM WILL BE REALLY VALUABLE. SO THANK YOU VERY MUCH. >> ANY QUESTIONS. >> WHAT IS THE AGE RANGE OF YOUR RECRUITING. WE'VE BEEN TALKING A LOT ABOUT ACROSS THE LIFE SPAN AND THE PHOTOS LOOKS PREDOME IN FACTUALLY ADULT. >> YES, YES, SO GREAT QUESTION. I FORGOAT TO MENTION THAT PART. SO IN OUR FIRST PHASE OF OUR LAUNCH WE'RE ONLY RECRUITING 18 AND OLDER. AND THE REASON FOR THIS--THERE ARE A VARIETY OF REASONS BUT THE MAIN REASON IS BECAUSE OF THIS TENET TO ACCESS FOR INFORMATION, SO WHEN YOU THINK ABOUT RETURN OF RESULTS AND GENOMICS INFORMATION CAN WE WANT TO BE THOUGHTFUL ABOUT HOW WE DO THAT IN TERMS OF ENROLLING KIDS SO WE WANT TO MAKE SURE THAT WE--WE BUILD A PROGRAM THAT WE'RE VERY CONFIDENT IN BEFORE WE START TO ENGAGE CHILDREN AND FAMILIES INTO THE STUDY, BUT THAT IS DEFINITELYOT RADAR SCREEN FOR AFTER THE FIRST YEAR OF LAUNCH. >> OT OTHER END OF THE LIFE SPECTRUM? >> YES. >> SO WE'RE--WE'RE NOT INHIBITING OR MAKING THAT AN INCLUSION CRITERIA, WE ARE TARGETING THE ELDERLY POPULATIONS AS WELL. YEAH. AND YOU MIGHT IMAGINE THIS HAS BEEN A KEY QUESTION BECAUSE OF THE DIGITAL ASPECT OF THIS SO MAKING SURE THAT WE HAVE PARTNERS TO HELP INDIVIDUALS WHO MAY NOT BE SAVVY WITH THE DIGITAL TECHNOLOGY TO MAKE SURE THEY ALSO HAVE THE OPPORTUNITY TO ENROLL. >> JAN? >> I JUST WANT TO SAY THANK YOU FOR THAT PRESENTATION. THAT IS BIG. IT'S HARD TO REALLY GET THE FULL SCOPE BECAUSE THERE IS SO MUCH. SO WILL THIS BE ON THE WEB SITE TAKEN--THEY WE CAN STUDY IT OUT FURTHER? >> OH YES. SO, YEAH, I DON'T KNOW IF IT'S THE PRECISION MEDICINE INITIATIVE WEB SITE OR THE ALL OF US WEB SITE. I BET YOU IF YOU TYPE IN PRECISION MEDICINE INITIATIVE IT WILL POP UP. >> [INDISCERNIBLE] >> ALL RIGHT, GOOD. OKAY. CONGRATULATIONS, IT'S BEAUTIFUL. >> AND IN THAT YOU WILL BE ABLE TO SEE WHO THE PARTNERS ARE AND SORT OF THE FUNDING AND OPPORTUNITIES THAT WILL BECOME AVAILABLE AS WELL. >> SO GIVEN THE NATURE OF THIS STUDY, IS THIS ALL BEHIND THE FIRE WALL, HOW IS THE [INDISCERNIBLE] PROTECTED [INDISCERNIBLE] HOW WILL THIS IDENTITY? HOW DOES IT WORK WITH THE [INDISCERNIBLE] ACROSS THE BOARD STUDY? WHAT MECHANISM YOU HAVE TO PROTECT? >> SO ALL PEOPLE WHO ARE PROVIDING ANY CLINICAL DATA HAVE TO BE HIPAA COMPLIANT. AND ONCE THEIR DATA ARE IN THE DATABASE IT IS UNDER A FED RAMP AND FISMA MODERATE LEVEL OF SECURITY AND SO THERE'S A COUPLE OF THINGS JUST IN TERMS OF THE HIPAA PRIVACY RULE BUT ALSO THE SECURITY PRIVACY RULE. ON TOP OF THAT, WE ALSO HAVE EVERY ENTITY COVERED BY A CERTIFICATE OF CONFIDENTIALITY AND THE CERTIFICATES OF CONFIDENTIALITY ARE 1S IN WHICH THEY RECENTLY ADDED A FEW MORE TEETH IN THE TERRATIVEICATE SO THAT IT SAYS EXPLICITLY THAT YOU DO NOT NEED TO PROVIDE THE INFORMATION TO PEOPLE WHO MIGHT BE SEEKING IT THROUGH SOME SORT OF LEGAL MEANS. AND THAT WAS SOMETHING THAT WE WORKED ON AND PRIOR TO ACTUALLY AWARDING THESE GRANTS THAT WAS SOMETHING THAT HAD COME UP AS A NEW POLICY WITHIN THE CERTIFICATES THAT THEY DO PROVIDE A BIT MORE PROJECTION. NOW THAT SAID, HAVING CHALGERGED YET EITHER. SO YOU KNOW I THINK THAT--I DON'T WANT TO SAY THAT WE'RE GOING TO BE ABLE TO PROTECT REALLY SOMEONE WHO IS INTERESTED IN HACKING THE SYSTEM. I'M FROM THE GOVERNMENT AND OUR OMB WAS HACKED SO THAT SHOULD BE PRETTY SECURE. SO I DON'T WANT TO SAY THAT THERE'S NOT A RISK BUT I THINK THAT WHAT WE KNOW NOW, THAT RISK IS WE'RE DOING THE BEST WE CAN TO MAKE SURE THAT RISK IS AS MINIMAL AS POSSIBLE. AND WE ALSOMENT TO MIC SURE WE COMMUNICATE THAT VERY PIECE OF INFORMATION TO THE PARTICIPANTS THROUGH THE CONSENT FORM. >> JUST TO COMMENT ON THAT. THIS WAS A VERY BIG TOPIC IN THE EARLY PLANNING STAGES AND THIS WHOLE CONCEPT OF THE DATA ENCLAVE CREATES A SEPARATE SET OF PROTECTIONS BECAUSE IT CREATES THE ABILITY TO TRACK AND MISUSE OF THE DATA AND THEREFORE, IF DATA IS MISUSED OR HACKED, CAN YOU ALSO HAVE ENFORCEMENT MECHANISMS TO FIND OUT WHO DID IT. AND HOW IT HAPPEN. SO DATA WILL BE DEIDENTIFIED SO PEOPLE WHO USE THE DAILY BASIS AT IT WILL BE USE INDEED A WAY THAT IS BEING ELECTRONICALLY MONITORS AND-- >> YEAH, THAT'S A GOOD POINT. AND IN ADDITION THE WAY THE DAT ENCLAVE IS ESTABLISHED, SO NOT ONLY FOR THE DATA PROVIDENCE PART WHICH IS REALLY IMPORTANT BUT ALSO FOR THE DATA FLOW, SO WHEN DATA COME NTHEY ARE--THEY'RE HELD IN WHAT WE CALL A DATA LAKE, A RAW DATA LAKE WHICH WILL CONTAIN PHI INFORMATION. ALL THOSE DATAL BE TRANSITIONED TO A CURATED DATA SET WHICH ARE DEASHES DENTIFIED DATA AND THAT'S THE DATA SET THAT WILL BE AVAILABLE TO RESEARCHERS AS WELL. SO THERE'S ALSO JUST INTERNALLY THERE'S CONTROL SYSTEMS THAT CREATE SAFER ENVIRONMENT. >> VERY INTERESTING, TELL BE A HUGE ASSET. I'M CURIOUS WHETHER YOU'RE ENCOUNTERING ANY TYPES OF INSTITUTIONAL BARRIERS FROM HOSPITAL I.T. DEPARTMENTS? ESPECIALLY THOSE GROUPS THAT USE EPIC WHERE THERE'S GENERALLY A BIT OF DESIRE NOT NECESSARILY TO PERMIT THIS FEEDING OF DATA OUTSIDE OF THE EPIC SYSTEM, SO I'M CURIOUS, YOU KNOW, ARE YOU RUNNING INTO ANY HEAD WINDS AS IT RELATES TO THE RELATIONSHIP BETWEEN THE SYSTEM AND ELECTRONIC RECORDS, THE 2 AND FROM COMPONENTS TO THAT? >> YEAH, GREAT QUESTION. THERE'S A LOT TO THAT QUESTION, TOO, SO--I'M GOING--I'LL TRY TO HIT ON A COUPLE OF THINGS. SO EPIC IS THE LARGEST OF COURSE VENTER AND SO, THEY'RE PROBABLY THE BULK--I'M GOING TO GUESS HERE 70% OF THE HEALTH RECORDS THAT ARE THROUGH THE PROGRAM RIGHT NOW. CERNER IS ANOTHER BIG 1. SO BETWEEN THOSE 2, THERE ARE A COUPLE OF HEALTHCARE PROVIDER ORGANIZATIONS WHO ARE MODEL CITIZEN WORKING NOT JUST WITHIN THEIR OWN EN--STRATEGIES TUITION BUT PARTNERING WITH OTHER INSTITUTIONS AND SO SOME OF THEM HAVE EPIC, SOME OF THEM HAVE CERNER. AND SO, MAKING SURE THAT THEY CAN GET THEIR I.T. SYSTEMS TO WORK TOGETHER. SO WHAT THEY'VE DONE IS CREATED DATA PIPELINES AND A VIRTUAL WAREHOUSE ESSENTIA WILY FOR THEIR SPECIFIC GROUPS THAT HAVE TO CAPTURE DIFFERENT TYPES EHR DATA RECORDS. THEY CREATE THE VIRTUAL DATA WAREHOUSE AND WITHIN THAT THEY TAKE THE ELECTRONIC HEALTH RECORDS AND CREATE THE COMMON DATA MODEL THAT WILL BE USED FOR THE PROGRAM AND SO EXTRACTING THE INFORMATION AND PROVIDING THAT THROUGH THAT WAREHOUSE TO THE DATA AND RESEARCH CENTER. SO THERE'S AN INTEGRITY WITHIN THE SYSTEM THAT THE ACTUAL HEALTH RECORDS DON'T EVER LEAVE, IT'S THE COMMON DATA MODELING AND CAPTURE INFORMATION FROM THOSE. SO THAT'S WOB. THE SECOND PART IS THOUGH SWHAT'S A BIT MORE CHALLENGING IS THAT THERE ARE HEALTH--INDIVIDUALS DON'T TYPICALLY GO SEE 1 DOCTOR. THEY GO TO A VARIETY OF DOCTORS AND IT'S--IT'S UNDERSTANDING IF THOSE--ESPECIALLY IN RURAL POPULATIONS THEY MAY NOT BE IN THE SAME MEDICAL CENTER, INSTITUTION, AND SO, UNDERSTANDING WHAT WE'RE MISSING OR HOW TO GO ABOUT FILLING IN THOSE GAPS IS ANOTHER IMPORTANT AREA AND I--I DON'T THINK WE'VE SOLVED THAT 1 JUST YET, BUT WE--WE KNOW SO THAT'S HALF A BATTLE AND THEN WE'RE WORKING TOWARDS UNDERSTANDING HOW WE CAN REALLY START TO LINK THOSE RECORDS IN AND I THINK THAT'S GOING TO TAKE EXPERIENCE, PROBABLY AND REALLY PEOPLE WHO ARE DEDICATED TO MAKING THAT HAPPEN. BUT BRINGING IN, YOU KNOW THE FEDERALLY QUALIFIED HEALTH CENTERS AND OTHER HEALTH CENTERS OVER TIME THAT WILL BE SOMETHING REALLY IMPORTANT THAT I THINK WE WILL LEARN A LOT ABOUT HOW THOSE SYSTEMS ARE ABLE TO COMMUNICATE ACROSS 1 ANOTHER. AND THEN WITH THE THINK FOR SCIENCE PROGRAM, ALL 7 VENDORS ARE ON BOARD WITH SINK FOR SCIENCE PROGRAM AND THEY'RE INVESTING RESOURCES IN TIME AND UNDERSTANDING HOW THEY CAN CREATE THESE TYPES OF MOBILE BASED INFORMATION GATHERING FOR THEIR--FROM THEIR PATIENT PORTALS TO THIS PROGRAM. AND I THINK THAT'S GOING TO BE ANOTHER SOURCE WHERE IT WILL TELL US A LOT ABOUT HOW WELL WE'RE GOING TO BE ABLE TO DO THAT. SO I THINK WE'RE GOING TO GO THROUGH GROWING PAINS IN THIS SPACE BUT I ALSO THINK WE WILL LEARN A LOT. SO I DON'T KNOW IF THAT REALLY ANSWERED YOUR QUESTION, BUT I HOPE IT GAVE YOU SOME INSIGHT INTO HOW THAT'S HOW WE'RE THINKING. >> THANK YOU SO MUCH JONI, THIS IS AN MARX ZINDERRING MOUNT OF WORK. THERE WILL BE A LOT MORE GOING FORWARD. SO,--SO IT WOULD BE GREAT, I THINK AS TIME GOES ON, AND YOU GET MORE RICH TYPE DATA, CERTAINLY PAIN IS SOMETHING THAT YOU KNOW THE PEOPLE OUT THERE, EVERYBODY EXPERIENCES IT AND TO TRY TO CAPTURE SOME OF THIS TYPE OF A POPULATION, WOULD BE FANTASTIC. SO GREAT. I THINK WE HAD AN UNBELIEVABLE DIVERSE DAY TODAY. I DON'T KNOW IF ANYBODY HERE WHO'S BRAIN IS THROBBING BUT THERE'S A LOT OF GOOD INFORMATION, GOOD DISCUSSION, GREAT COMMITTEE AND SO, WE'LL BE WORKING HARD TO MOVE TO OUR NEXT IPRCC MEETING AND GET AN EQUALLY ENGAGING AGENDA. THE SO I THINK--WITH THAT, DO WE HAVE ANY OTHER? >> NO. >> WE'RE GOOD TO GO. THANKS VERY MUCH. >> THE ONLY BUSINESS WE NEED TO TAKE CARE OF IS GETTING PEOPLE EITHER BACK TO THE HOTEL OR THE AIN'T. SO SO IF THE PEOPLE WHO NEED A CAB, GO TO THE TABLE WITH THE RED CURTAIN ON IT SO WE CAN GET PARENTS HOME TO THEIR HALLOWEEN CHILDREN. THAT'S THE MOST IMPORTANT NEXT STEP. >> THANK YOUAL FOR COMING IT'S BEEN GREAT. >> THANK YOU EVERYBODY.