>> GOOD MORNING, I'M DR. JOAN McGOWAN, THE DIRECTOR OF DIVISION OF MUSCULOSKELETAL DISEASES, AND AMONG MANY OF THE INSTITUTES BACK PAIN IS ONE OF OUR PRIORITY AREAS. I AM REALLY PRIVILEGED TO BE INTRODUCING YOUR GREAT TEACHER FOR TODAY, DR. RICK DEYO IS THE KAISER PERMANENTE ENDOWED PROFESSOR OF ED-BASED MEDICINE IN THE DEPARTMENT OF FAMILY MEDICINE AT THE OREGON HEALTH AND SCIENCE UNIVERSITY. HE IS ALSO A LONG-TERM GRANTEE TITUTES OF BOTH THE NATIONAL OF HEALTH, SEVERAL INSTITUTES, AS WELL AS THE AGENCY FOR HEALTH CARE RESEARCH AND QUALITY. HE RECEIVED HIS MEDICAL TRAINING FOR THOSE ALUMSw3 AT THE PENN STATE, AND ALSO DID COMPLETED A RESIDENCY IN INTERNAL MEDICINE AT THE UNIVERSITY OF TEXAS AT SAN ANTONIO, AND HE RECEIVED A MASTER OF PUBLIC HEALTH AT THE UNIVERSITY OF WASHINGTON AS A ROBERT WOOD JOHNSON CLINICAL SCHOLAR. HE'S CO-EDITOR OF THE JOURNAL, SPINE, AS WELL AS SERVING AS A MEMBER OF THE EDITORIAL BOARD OF THE BACK REVIEW GROUP OF THE COCHRANŤŤ COLLABORATION. HE ALSO HAS BEEN CO-EDITOR OF A BOOK ON EVIDENCE-BASED CLINICAL PRACTICE; CONSENTS AND APPROACHES, AND HE'S RECEIVED THE JOHNIZEN BURG AWARD FOR CAREER ACHIEVEMENT FROM THE SOCIETY OF GENERAL INTERNAL MEDICINE AND IS A MEMBER OF THE AMERICAN SOED FOR CLINICAL INVESTIGATION. DR. DEYO HAS A LONG-STANDING INTERESTŤ IN MEASURING PATIENT FUNCTION, IN INVOLVING PATIENTS IN CLINICAL DECISIONS, AND IN MANAGING LOW BACK PAIN. HE ALSO STUDIES THE INAPPROPRIATE USE OF MEDICAL TECHNOLOGY IN COMMERCIAL, POLITICAL AND MEDIA FORCES THAT AFFECT IT. THIS INTEREST LED HIM TO PUBLISH A BOOK SOMEWHAT FOR THE PUBLIC, BUT CERTAINLY FOR MEDICAL PROFESSIONALS TOO CALLED, "HOPE OR HYPE: THE OBSESSION WITH MEDICAL ADVANCES AND THE HIGH COST OF FALSE PROMISES." THE NEW ENGLAND JOURNAL OF MEDICINE REVIEWER SAID THAT DEYO AND HIS CO-AUTHOR WELL DOCUMENTED AND DEPRESSING ARGUMENT THAT DRR DOCTORS, SCIENTISTS ANDED LAYPERSONS ALIKE ARE FAR TOO EASY HLY SEDUCED BY INDUSTRY HYPE FOR THE MERELY NEW AS OPPOSED TO THE TRULY BETTER DRUGS AND MEDICAL DEVICES. AVAILABLE ON AMAZON FOR YOUR KINDLE. DR. DEYO DIDN'T BRING A PATIENT TODAY, YOU'LL SEE, ALTHOUGH HE'LL TALK ABOUT SOME, AS MANY OF OUR GREAT TEACHERS/SPEAKERS DO, BUT I KNOW THAT HIS BACK PATIENTS ARE OUT THERE IN THE AUDIENCE. THE PREVALENCE OF BACK PAIN IS SO HIGH IN THE UNITED STATES THAT I'M SURE THAT MANY OF YOU HAVE EXPERIENCED IT, AND I HOPE THAT IT'S ONLY BEEN THE ACUTE KIND FROM SHOVELLING SNOW OR TOO MUCH SALSA DANCING AND NOT CHRONIC BACK PAIN THAT IS SOŤ—my DEVASTATING TO BOTH THE QUALITY OF LIFE OF PATIENTS AND THEIR FAMILIES AS WELL AS A TREMENDOUS COST TO THE HEALTH CARE SYSTEM.Ť BEFORE I BRING DR. DEYO TO THE PODIUM, I'D LIKE TO SAY THAT THE NIH HAS ENGAGED DR. DEYO AS THE CO-CHAIR OFw3 A PAIN CONSORTIUM TASK FORCE THAT IS LOOKING TO DEVELOP RESEARCH DIAGNOSTIC CRITERIA FOR BACK PAIN, AND WE HOPE THAT THIS IS THE LEADER EDGE OF MORE AND BETTER RESEARCH IN THIS VERY IMPORTANT PUBLIC HEALTH AREA. DR. DEYO. [APPLAUSE]–r >> THANKS VERY MUCH, JOAN. IT'S A REAL HONOR AND PRIVILEGE FOR ME TO BE HERE JOINING YOU TODAY. AS JOAN IMPLIED, BACK PAIN'S ONE OF THOSE THINGS THAT'S SORT OF UBIQUITOUS AND YET I SOMETIMES REFER TO IT AS AN ORPHAN CONDITION BECAUSE THERE SUCH A POSTY OF RIGOROUS RESEARCH IN THIS AREA AND THAT'LL ONE OF THE THEMES OF MY PRESENTATION TODAY WHICH IS, AS YOU'LL SEE, SORT OF A CONTRARY YAN VIEW ABOUT MANY OF THE THINGS WE DO WITH REGARD TO BACK PROBLEMS. SO I REALLY APPRECIATE THE INVITATION, AND SPEAKING OF INVITATIONS, I HAVE TO ACTUALLY SHOW YOU THE LETTER HEAD ON LETTER THAT CAME TO ME WITH THIS INVITATION WHICH STRUCK ME RIGHT AWAY. I'M A LONG-TIME RESIDENT NOW OF THE PACIFIC NORTHWEST AND HERE'S WARREN T.MAGNUSEN, I LIVE ABOUT FIVE BLOCKS FROM HIS PARK IN SEATTLE AND HE WAS MY SENATOR WHEN I MOVED TO SEATTLE FOR THE FIRST TIME. AND MARC HATFIELD WHO'S THE SENATOR FROM OREGON HAS JUST DIED LAST YEAR, ACTUALLY, SO ALMOST MY SENATOR IN OREGON, SO HERE'S BIPARTISAN SUPPORT FOR THIS CENTER AND I JUST WANT TO REMIND YOU THAT THE PACIFIC NORTHWEST IS HOME TO ENLIGHTENED PEOPLE WHO ELECT PUBLIC-MINDED REPRESENTATIVES WHO ARE VERY SUPPORTIVE OF THE MISSION HERE. SO MY DISCLOSURE, THE ONLY COMMERCIAL TIE THAT I BELIEVE I HAVE IS WITH UP-TO-DATE, WHICH IS AN ONLINE REF BOOK, IF YOU WILL WHERE I AUTHOR SOME TOPICS ONZv LOW BACK PAIN. THE OBJECTIVES THAT I WANTED TO COVER REALLY ADDRESS THREE CONTROVERSIES THAT ARE COMMON PROBLEMS IN MANAGING PATIENTS WITH BACKF WE'LL TALK A LITTLE BIT ABOUT THE RELEVANCE TO PATIENTS AND TO THE HEALTH CARE SYSTEM. I'LL TRY TO DESCRIBE THE EVIDENCE FOR OVERUSE OF SOME OF THESE THINGS, AND CONSIDER BOTH WHAT WE KNOW ABOUT THEIR EFFICACY AND THEIR SAFETY. AND THEN TALK A BIT ABOUT SOME STRATEGIES THAT WE MIGHT BE CONSIDERING FOR MORE SELECTIVE USE OF THESE PARTICULAR CLINICAL MANAGEMENT STRATEGIES. SO, IN TRADITIONAL GRAND ROUND STYLE, LET ME START WITH A CASE REPORT. THIS IS A STORY OF GENERAL DAVID FREEDVICH AND I THINK I'M AT LIBERTY TO TALK ABOUT THIS BECAUSE HIS STORY WAS REPORTED IN THE U.S.A. TODAY AND HE'S TO BE CONGRATULATED FOR BEING SO OPEN ABOUT THIS STORY. UM, HE WAS AT THE TIME A KOUR NEL IN 2006 WHEN HE WAS DOING LEG PRESSES IN HAWAII AFTER VISITING IRAQ AND HE FELT A TWINGE. HE WEPT TRAINING AP'D PLAYING BALL FOR SEVERAL MORE DAYS. ONE MORNING, HE AWOKE BARELY ABLE TO STAND AND HE HAD PAIN RADIATING DOWN HIS LOW BACK DOWN HIS LEFT LEG. HE SAW ONE OF THE PHYSICIANS IN THE EMERGENCY ROOM THERE IN HAWAII, HAD AN X-RAY. ACCORDING TO THE NEWSPAPER, HE HAD SHATTERED BONES WHICH I'M GUESSING PROBABLY MEANS COMPRESSION FRACTURES AND PINCHES NERVES. HE WAS STARTED ON MOTRIN AND MORPHINE INITIALLYLY AND THEN ON ROCK IS I SET AND OXICOTEN. THE KOUR NEL REPORTED THAT HE FIGURED IF DRUGS WERE FOR PAIN RELIEF THEN MORE DRUGS WERE GOING TO GIVE HIM MORE RELIEF. HE REPORTED TAKING MORE THAN PRESCRIBED, HE ALSOzV REPORTED BEING DEPRESSED. E DECREASED THE DOSE BUT DID CONTINUE ON THESE TWO DRUGS AND BY HIS SELF REPORT BECAME ISOLATED AND COMBATTIVE. THEN IN 2008, HE ACTUALLY WENT A SPINE FUSION. THE DOSE OF HIS OPIOID WAS INCREASED AND HE CONTINUED THEM POSTOPERATq,i1e WHICH TURNS OUT TO BE A COMMON STORY. A FEW WEEKS LATER, HE SAW ANOTHER MILITARY PHYSICIAN IN FLORIDA WHO HAD THE TA MARTY TO TELLv: THE GENERAL THAT HE HAD A LONG-STANDING OPIOID PROBLEM. HE UNDERWENT A FOUR-WEEK DETOX PROGRAM AND WAS PUT ON ANOTHER MEDICINE AND A FEW YEARS LATER WAS NAMED COMMANDER OF THE FORCES. HE'S A DIRECTOR OF THE GREEN BAA RAYS, NAVY SALEEALS, THE SPECIAL FORCES. HE'S A TOUGH GUY. HE SAID THE DETOX CLEARED HIS HEAD, BRIGHTENED HIS OUTLOOK ON LIFE. HE SAID I PROBABLY SHOULD TAKE AN AD OUT Ť—w3POLOGIZING TO PEOPLE. HE'S CLEARLY A TOUGH GUY, NOT A WHINER, NOT A HOMELESS PERSON, NOT A DRUG ABUSER, NOT LAZY, AND YET HERE HE IS DEVELOPING AN IMPORTANT OPIOID DEPENDENCE PROBLEM. OPIOIDS WERE STARTED EARLY IN HIS KAY CASE. WE DON'T KNOW THE CLINICAL DETAILS AROUND THAT EPISODE, BUT IT'S PROBABLY APPROPRIATE TO ASK IF OPIOIDS WERE NECESSARY AS A FIRST STEP. HE FOUND IT HARD TO STOP AS MANY PEOPLE DO, AND HE CONTINUED THE OPIOIDS EVEN AFTER SURGERY AS MANY PEOPLE DO. HE REPORTED THAT HE THOUGHT HIS MOOD WAS CHANGED WHILE HE WAS TAKING THESE DRUGS, AND HE FELT BETTER WHEN HE WAS FINALLY TAPERED FROM THE DRUGS. SO WHAT'S HAPPENED WITH OIP YOID PRESCRIBING IN THISq THE PAST 15 YEARS OR SO IS THIS, A 600% INCREASE IN EXPENDITURES SPECIFICALLY FOR BACK ŤPAIN. THIS IS BACK AND NECK PAIN, ACTUALLY, AND THIS IS A RESULT OF BOTH INCREASES IN VOLUME OF PRESCRIBING AND IN THE COST OF THE MEDICATIONS,w3 THEMSELVES, BUT I WOULD ARGUE THAT A 600% INCREASE OVER A ROUGHLY 10-YEAR SPAN IS PROBABLY NOT GOING BE SUSTAINABLE.Ť SO WHAT DO WE KNOW ABOUT THE EFFICACY OF OPIOIDS FOR CHRONIC LOW BACK PAIN? AND THIS IS NOT ACUTE BACK PAIN. WE'RE NOT TACKING ABOUT POSTOPERATIVE PAIN, NOT TALKING ABOUT PAL TATIVE CARE OR ONCOLOGY, BUT FOR CHRONIC LOW BACK PAIN, WHAT'S THE EVIDENCE? THERE HAVE BEEN AŤ COUPLE OF SYSTEMATIC REVIEWS ON THIS TOPIC, ONE OF WHICH WAS IN THE [INDISCERNIBLE] OF INTERNAL MEDICINE JUST A FEW YEARS AGO AND THAT STUDY CONCLUDED THAT THE AVAILABLEkO RANDOMIZED TRIALS WERE ALL OF RELATIVELY POOR QUALITY AND THAT NONE OF THEM ACTUALLY EXTENDED BEYOND 16 WEEKS, EVEN THOUGH WE ALL HAVE PATIENTS, I SUSPECT, WHO HAVE BEEN ON OPIOIDS FOR CHRONIC PAIN, CHRONIC NON--CANCER PAIN FOR YEARS AND EVEN DECADES WHERE I WOULD ARGUE WE KNOW VERY LITTLE ABOUT THE EFFICACY AND SAFETY OF THESE DRUGS. THAT REVIEW CONCLUDED THAT FOR CHRONIC LOW BACK PAIN, THERE WAS A NON--SIGNIFICANT REDUCTION IN PAIN AS SDPAR COMPARED TO NON-OPIOIDS OR PLACEBO THEY WERE PISHG EVEN, ALTHOUGH THE TREND WAS IN FAVOR OF OPIOIDS. THE SAME AUTHORS TRIED TO ESTIMATE THE PREVALENCE OF SUBSTANCE USE DISORDERS AMONGjF THE PATIENTS RECEIVING LONG-TERM OPIOIDS FOR CHRONIC BACK PAIN. THESE NUMBERS ARE FAIRLY HIGH WITH AN ESTIMATED LIFETIME PREVALENCE OF SUBSTANCE USE DISORDERS AS HIGH AS 50%, AND AGAIN THESE ARE THE HIGH END OF THE RANGES THAT THEY SITED, BUT ALARMING NUMBERS IN ANY EVENT, AND A REVIEW IN THE COCHRANE DATABASE CAME TO A A VERY SIMILAR CONCLUSION THAT ANY BENEFIT OF OPIOIDS FOR CHRONICw3 LOW BACK PAIN IS QUESTIONABLE. THOSE ARE THE RANDOMIZED TRIALS. WHAT ABOUT THE REAL WORLD? ROUTINE CARE OUTSIDE THE HIGHLY CONTROLLED ATMOSPHERE OF A RANDOMIZED TRIAL? THERE ARE A COUPLE OF DESCRIPTIVE STUDIES, OBSERVATIONAL STUDIES. ONE IS A STUDY THAT WE DID FROM PORTLAND LOOKING AT REGIONAL DATA FOR THE V.A. IN WHICH WE FOUND PATIENTS RECEIVING HIGH-DOSE OPIOIDS ACTUALLY REPORTED HIGHER PAIN LEVELS ON THEIR HIGH-DOSE OPIOIDS THAN PATIENTS WHO WERE RECEIVING LOWER DOSES. OF COURSE, THERE'S A SELECTION PROBLEM THERE. IT MIGHT BE THAT PATIENTS WITH THE WORST PAIN GET ON THE HI I THINK YOU WOULD HAVE TO CONCLUDE THAT AT LEAST THOSE OPIOIDS ARE NOT REDUCING THEIR PAIN EVEN TO THE SAME LEVEL AS OTHER PATIENTS WITHw3 CHRONIC PAIN WHO TAKE LOWER DOSES O OF OPIOIDS. THEN THERE THE DANISH POPULATION SURVEY THAT CONCLUDED THAT AMONG CHRONIC PAIN PATIENTS USING OPIOIDS THEYv: REPORTED A LOWER QUALITY OF LIFE AND MORE SEVERE PAIN THAN PATIENTS WITH PROCHRONIC PAIN WHO WERE NOT RECEIVING OPIOID THERAPY. I THINK THESE OBSERVATIONAL STUDIES CHALLENGE THE NOTION THAT THESE DRUGS ARE HAVING A MAJOR IMPACT ON THESE PATIENTS' LIVES. THEN THE OTHER IMPORTANT THEME IN THE LAST COUPLE OF YEARS HAS BEEN THE9Y GROWING EVIDENCE OF IMPORTANT COMPLICATIONS, SIDE EFFECTS. ONE OF WHICH IS DEATH WHAT YOU SEE HERE IS A GRAPH OF PRESCRIPTION OPIOID SALES ON THE YELLOW LINE.. WHAT YOU SEE HERE IS A GRAPH OF PRESCRIPTION OPIOID SALES ON THE YELLOW LINE. PARALLELING IT IN ORANGE IS THE NUMBER OF DEATHS WITH OPIOIDS INVOLVED. MOST OF THESE OBVIOUSLY BEING OVERDOSE DEATHS, AND THAT NUMBER IS NOW EXTENDED UP TO ALMOST 15,000 IN 2008. SIGNIFICANT MORTALITY ASSOCIATED WITH INCREASING USE–r OF OPIOID THERAPY. AND THERE'S BEEN A SERIES IN THE PAST YEAR OF STUDIES LOOKING AT THE RELATIONSHIP BETWEEN DOSE AND OVERDOSE RISK OR MORTALITY RISK. THE TRADITIONAL TEACHING, I THINK, IT COULD BE FAIRLY DESCRIBED AS SAYING THAT THERE'S NO UNSAFE DOSE OF OPIOIDS AS LONG AS YOU INCREASE THE DOSE GRADUALLY ENOUGH, WE NEED NOT WORRY ABOUT RESPIRATORY DEPRESSION AND THAT KIND OF SITUATION AND SO FORTH. THE DATA FROM THIS PAST YEAR REALLY CHALLENGED THAT NOTION. THIS IS JUST ONE EXAMPLE. THESE ARE DATA FROM A STUDY DONE AT GROUP HEALTH COOPERATIVE IN SEATTLE, IN WHICH PATIENTS WERE IDENTIFIED WHO WERE JUST INITIATING OPIOIDS, FIRST-TYPE OPIOID DESCRIPTIONS AND THEN FOLLOWED FOR AN AVERAGE OFŤŤ FOUR YEARS, AND OVERDOSES WERE IDENTIFIED IN THIS GRAPH I'VE SHOWN YOU SERIOUS OVERDOSES WHICH MEANT THAT THESE WERE PATIENT WHO IS EITHER DIEDED OR HAD TO BE HOSPITALIZED, HAD COMA OR OTHER SUBSTANTIAL RESPIRATORY DEPRESSION, SUBSTANTIAL COMPLICATIONS. THESE WERE NOT JUST DIZZINESS. THE RISK OF OVERDOSE INCREASES SOMEWHAT EVEN AT LOW DOSES OF OPIOIDS, AND INCREASES WITH INCREASING DOSE, THESE ARE MORPHINE EQUIVALENT DOSES HERE. ABOUTf‡ 100 MILLIGRAMS A DAY THE RISK OF OVERDOSE SHOOTS UP DRAMATICALLY. A HAZARD RATIO OF 11 AT THAT POINT, WHICH IS CLEARLY A MAJOR STEP UP FROM THE LOWER DOSES. THE OTHER IMPORTANT OBSERVATION THEY MADE WAS THAT CO-PRESCRIPTION SEDATIVE HIP NO TICKS INCREASED THE RISK OF OVERDOSE, SOMETHING CLINICIANS ARE FAMILIAR WITH. YOU MIGHT SAY WE KNOW THAT AND CAUTION ABOUT IT, BUT IN FACT WE HAD AN OPPORTUNITY TO LOOK AT OPIOID PRESCRIBING IN THE KAISER HEALTH CARE SYSTEM IN PORTLAND, AND CHARACTERIZED PATIENTS ACCORDING TO WHETHER THEY WERE TAKING -- THESE ARE ALL PATIENTS WITH CHRONIC LOW BACK PAIN OR I SHOULD SAY PATIENTS WITH LOW BACK PAIN -- CHARACTERIZED THEM AS TAKING NO OPIOID, ACUTE OR LONG-TERM OPIOIDS. WHAT WE FOUND WAS THAT THE LIKELIHOOD OF HAVING A CO-PRESCRIPTION OF SEDATIVE HIP NO TICKS ACTUALLY INCREASED WITH INCREASING DURATION OF OPIOID THERAPY SO THAT ALMOST HALF THE PATIENTS ON LONG-TERM OPIOID THERAPY WERE ALSO GETTING SEDATIVE HIP NO TICKS, JUST THE OPPOSITE OF WHAT UH YOU WOULD HOPE FOR AND EXPECT GIVEN THE RISK OF CO-PRESCRIBING. AND THEN YET ANOTHER THEME EMERGING IS THE RISKS BEYOND OVERDOSE, BEYOND DRUG TOLERANCE, BEYOND DEPENDENCE AND ADDICTION. THERE ARE SOME IMPORTANT LONG-TERM COMPLICATIONS FROM OPIOID USE. ONE OF THESE IS CLEARLY AN ENDOCRINE LOGICAL EFFECT OF OPEN OPIOIDŤ USE WHICH CAN [INDISCERNIBLE] SO THAT FOR MINUTE IT'S A PROBLEM OF DECREASES LA BEE DOE AND ERECTILE DISFUNCTION. IN WOMEN CAN BE RESULT IN INFERTILITY, NOT A TRIVIAL PROBLEM. ANOTHER PROBLEM THAT'S COME TO LIGHT IS THAT OPIOIDS SEEM TO BE A RISK FACTOR FOR OSTEOPOROSIS AND FOR FRACTURES. IT'S A COMBINATION N THIS CASE, OF BOTH FALLS AND OSTEOPOROSIS RISK SO THAT FOR PATIENTS OVER THE AGE OF 60, THE RISK OF FRACTURE IS DOUBLED AMONG PEOPLE TAKING DOSES OVERŤ 50 MORPHINE EQUIVALENCE PER DAY. THEN A THIRD IMPORTANT ISSUE IS THE QUESTION OF HYPER AL JEEZ YEAH. NOTION THAT PARADOXICALLY, PEOPLE ON LONG-TERM OPIOIDS MAY ACTUALLY IS A REDUCED PAIN THRESHOLD AND MAY ACTUALLY ENCOUNTER MORE PAIN PROBLEMS AS A RESULT OF LONG-TERM OPIOID THERAPY RATHER THAN LESS. THIS IS APPARENTLY DUE TO NEUROPLASTIC CHANGES THAT OCCUR IN THE BRAIN AND SPINAL CORD THAT BASICALLY ALTER PAIN THRESHOLD IN IMPORTANT WAYS THAT MAY BE COUNTER PRODUCTIVE. WELL, YOU HEARD IN JOAN'S INTRODUCTION THAT I'VE BEEN CONCERNED ABOUT THE ROLE OF INDUSTRY AND OVERUSE OF SOME MEDICAL THERAPIES, AND THIS IS A CASE WHERE I THINK THAT MAY BE AN ISSUE. OX XI COTTON WAS INTRODUCED IN 196 OR APPROVED, I SHOULD SAY N 1996 BY THE FDA, AND AT THAT TIME THERE WAS A GUIDELINE OR A STATEMENT ISSUE BID THE AMERICAN PAIN SOCIETY IN THE AMERICAN ACADEMY OF PAIN MEDICINE, A PANEL THAT WAS SUPPORTED HEAVILY FINANCIALLY BY PERDUPHARMA. YEARS LATER, THE COMPANY WAS ACTUALLY CONVICTED OF MARKETING OX XI COTTON AS BEING SAFER AND LESS ADDICTIVE THAN ITS COMPETITORS IN THE FACE OF EVIDENCE THAT WAS IN THEIR HANDS TO THE CONTRARY. IN 2007, THE COMPANY AND IT'S TOP EXECUTIVES PLED GUILTY TO FELONY CHARGES, AGREED TO $600 MILLION IN FINES, AND THE THREE EXECUTIVES ACTUALLY WERE PLACED ON PROBATION RATHER THAN JAIL SENTENCES. ANOTHER COMPANY IN 2008, SETTLED CRIMINAL AND CIVIL CHARGES FOR OFF-LABEL MARKETING FOR SEVERAL DRUGS INCLUDINGoku! ACTIQUE, A SETTLEMENT FOR $400 MILLION, AND IT'S BEEN CONCERNS LIKE THESE THAT LED JANE TO THIS QUOTE AT THE BOTTOM. SHE'S A PAIN MANAGEMENT SPECIALIST AT THE UNIVERSITY OF WASHINGTON. SHE SAYS, THEOK DRUG COMPANIES HAVE FOR YEARS PICKED THE MESSAGE AND THE MESSENGERS WHILE SPONSORS MUCH OF THE POST GRADUATE EDUCATION AND ALL MAJOR PAIN MEETINGS. AND SO WHILE ANECDOTES LIKE THAT ARE PERSONAL OPINION ARE CERTAINLY NOT EVIDENCE, I WANT TO MAKE THE POINT THAT EVEN AMONG FORMER ADVOCATES I THINK THE PAST YEAR OR SO HAS SEEN A SWING OF THE PENDULUM AWAY FROM OPIOID PRESCRIBING. ONE OF THE QUOTES HERE IS FROM MITCH CATS THE DIRECTOR OF P PUBLIC HEALTH DEPARTMENT IN LOS ANGELES WHO SAID I'VE COME TO QUESTION WHETHER LONG TERM HOPE YOID TREATMENT IS CAUSING MORE HARM THAN GOOD. SUDDENLY I FIND MYSELF TO BE BELIEVER -- WHICH HE WAS -- WHO HAS LOST HIS FAITH. JANE AGAIN ARGUING THAT WE'RE PROVIDING A TREATMENT THAT FOR MANY PATIENTS IS NOT IMPROVING THEIR PAIN BUT IS COMPROMISING THEIR LIVES AND FUTURES. SO%q I THINK WE COULD FAIRLY COME TO A MORE CAUTIOUS OPIOID PRESCRIBING APPROACH, WHICH MIGHT RUN SOMETHING LIKE THIS. CERTAINLY CONSIDER OTHER OPTIONS THAN OPIOID THERAPY IF POSSIBLE AS INITIAL APPROACH. OPIOIDS CLEARLY ARE USEFUL FOR ACUTE PAIN, BUT WHEN I SEE PATIENT WHO IS HAVE BACK PAIN AND ARE ACUTE, I TELL THEM THAT I'LL PRESCRIBE THESE MEDICATIONS FOR A RELATIVELY SHORT PERIOD OF TIME AND THAT AFTER THAT, WE'RE GOING TO HAVE TO SWITCH MEDICATIONS, AND I SOMETIMES HAVE FOLLOWED THE STRATEGY OF PRESCRIBING N SAIDS DURING THE DAY WITH OPIOID AT NIGHT TO HELP THEM SLEEP BUT A STRATEGY THAT AVOIDS HAVING THEM CONTINUOUSLY ON OPIOIDS DURING THE DAY. BASED ON DATA THAT'S EMERGED ON OVERDOSE AND MORTALITYa THAT A REASONABLE STRATEGY WOULD BE TO SAY WE SHOULD GENERALLY AVOID PRESCRIBING MORE THAN 100 MILLIGRAMS MORPHINE EQUIVALENT PER DAY AND WE PROBABLY SHOULD BE AVOIDING COPRESCRIPTIONS OF BENZODIAZEPINES. FOR PEOPLE CONSIDERING OPIOID USE, WE SHOULD SCREEN FOR SUBSTANCE ABUSE AND DEPRESSION AND PATIENTS NEED TO ENGAGE IN A SERIOUS, INFORMED CONSENT PROCESS BEFORE EMBARKING ON OPIOIDS. WE'VE TRADITIONALLY SAID DO THAT AFTER ABOUT THREE MONTHS OF OPIOID THERAPY, AND VI TO CONFESS THAT I'M BEGINNING TO WORRY THAT THAT'S TOO LATE, THAT THE HORSE IS OUT OF THE BARN AT THAT POINT, AND THAT, IN FACT, THAT CONSENT PROCESS WITH A REAL HONEST DISCUSSION OF THE BENEFITS AND RISKS NEEDS TO HAPPEN CONSIDERABLY EARLIER IF PATIENTS ARE GOING TO BE ABLE TO MAKE REALLY INDEPENDENT DECISIONS ABOUT THAT. MY EXPERIENCE IS THAT AT THREE MONTHS, EVERYBODY SIGNS THAT CONTRACT, NOT A SINGLE PATIENT HAVE I APPROACHED WHO DIDN'T SIGN THAT CONTRACT AND I THINK IT'S BECAUSE AT THAT POINT, THEY ARE ALREADY DEPENDENT AND VERY RELUCTANT TO STOP TAKING THE MEDICATIONS. THE AMERICAN PAIN SOCIETY TO THEIR CREDIT HAS TAKEN PART IN A MUCH NEWER GUIDELINE EFFORT WHICH I THINK IS CONSIDERABLY MORE CAUTIOUS THAN THE ONE THAT CAME OUT IN 1996. THEY REFER TO OPIOID THEY WERE FI PI FOR BACK PAIN AS AN OPTION FOR SEVERE DISABLING BACK PAIN. POINT OUT THAT ONE NEEDS TO CAREFULLY WEIGH THE BENEFITS AND RISKS AND CONSIDER ALTERNATIVE TREATMENTS IF THERE'S NO RESPONSE TO A SHORT COURSE. THAT WOULD BE QUITE DIFFERENT THAN SAYING, UM, CONSIDER INCREASING THE DOSE IF THERE'S NO RESPONSE TO A SHORT COURSE.Ť— SO LET ME SHIFT GEARS THEN AND TALK A LITTLE BIT ABOUT THE IMAGING CONTROVERSIES REGARDING BACK PAIN. LIKE OPIOID PRESCRIBING, SPINE IMAGING HAS JUST TAKEN OFF IN THE PAST DECADE. THESE ARE DATA THAT WE HAVE ANALYZED FROM MEDICARE CLAIMS. THESE ARE JUST PATIENTS O OVER AGE 65, AND OF COURSE IT'S TRUE FOR IMAGING IN GENERAL THAT IT IS JUST EXPLODED OVER THE PAST DECADE OR SO BUT THIS IS FOR LUMBAR SPINE IMAGING IN PARTICULAR A 300% INCREASE OVER A 12-YEAR TIME SPAN. WHY ARE WE DOING THE IMAGING? WE'RE LOOKING FOR ANATOMICAL ABNORMALITIES"N THAT THE IMAGING MIGHT REVEAL, AND THOSE CONDITIONS INCLUDE SOME OF THESE. -- THAT ARE HAPPILY ALL FAIRLY UNCOMMON. COMPRESSION PRAK FRACTURES, IN PRIMARY CARE PRACTICE PROBABLY COUNTS FOR A FEW OF THESE, SLIP OF ONE VERTEBRAE ON THE OTHER. CANCER TURNS OUT TO BE LESS THAN 1%. [INDISCERNIBLE] IS PROBABLY CONSIDERABLY LESS THAN ONE PERCENT. SPINAL ABSCESSES ARE WAY LESS THAN ONE PERCENT. SPINAL STENO SIS, I'VE HAD A HARD TIME GETTING A POPULATION-BASED FIGURE FOR THE PREVALENCE OF THAT JUST BECAUSE IT'S SO DEPENDENT ON IMAGING. SERGICALLY IMPORTANT DISHERNUATION A COUPLE PERCENT. BUT IF YOU ADD ALL THESE UP YOU'RE TALKING ABOUT MAYBE 10% OF SO OF PATIENT WHO IS HAVE BACK PAIN. WHAT ARE THE OTHER 90% HAVE? YOU'LL HEAR EXPERT PRONOUNCEMENTS LIKE THESE. ONE SAYS 80% OF BACK PAIN IS FROM WEAK OR TENSE MUSCLES. MAJORITY COMES FROM THE SACRAL LIGAMENTS. NEXT ONE SAYS IT'S MOSTLY DISKS. NEXT ONE SAYS ITFASHL PROBLEMS. IF YOU ADD THESE UP THAT'S ABOUT 400% OF PATIENT WITH BACK PAIN. I WOULD ARGUE THIS IS SPECULATION AND HYPOTHESES RATHER THAN DEMONS TRABL FACTS.Jf WHAT'S THE RISK OF DOING MRI IN PEOPLE WHO ARE AT LOW RISK FOR THOSE KINDS OF CONDITIONS. THERE'S NO SUCH THING AS A NORMAL MRI SCAN OF THE LUMBAR SPINE. THIS IS DATA FROM A GROUP OF SUBJECTS THAT HAVE ASSEMBLED BY AN ORTHOPEDIC SURGEON. HE WAS ABLE TO FIND 67 ADULTS WHO CLAIMED THAT THEY HAD NEVER HAD BACK PAIN OR SCIATICA. NEVER. HERE ARE THEIR MRI RESULTS FOR ADULTS UNDER THE AGE OF 60, ALMOST A QUARTER HAD A HERNIATED DISK, SPINAL STENO SIS WAS RARE. LOOK AT THIS, NEARLY HALF HAD A BULGING DISK OR DEGENERATING DIS, AND THAT'S UNDER AGE 60. FOR THOSE OF US OVER 60, OVER A THIRD HAD A HERNIATED DISK, SPINAL STENO SIS IN A FIFTH. THAT'S WITHOUT BACK PAIN OR LEG PAIN. NO SYMPTOMS, AND ESSENTIALLY EVERYBODY HAD EITHER A BULGING DISK OR DEGENERATED DISK P IF YOU'RE OVER 60 AND DON'T HAVE ONE OF THOSE THINGS, YOU'RE PROBABLY MORE ABNORMAL THAN SOMEONE WHO DOES. HERE'S ONE EXAMPLE. THIS SOMEONE OUFR STUDIES WHERE WE STUDY PATIENTS WHO ARE ASYMPTOMATIC. WE ALLOWED PATIENTS IN WHO HADd8 DISTANT BACK PAIN. PART LAST SIX MONTHS, NO BACK OR LEG PAIN. DOING WELL. WHAT YOU SEE ARE THREE NORMAL-LOOKING DISKS HERER IN THE CENTER OF THE PHOTO AND THREE BLACK DISKS DOWN HERE. THAT MEANS THEY'VE LOST THEIR NORMAL WATER CONTENT. A COUPLE OF THESE ARE FRANKLY HERNIATED DISKS, AND UP HERE YOU SEE ANOTHER DISK WHERE THE DISK SPACE IS ALMOST COMPLETELY GONE, AL ALSO BLACK. THIS IS A HORRIBLE-LOOKING LUMBAR SPINE BUT THIS PATIENT'S HAVING NO SYMPTOMS AT ALL. YET, IF HE WALKED IN AT TEND OF THE WEEKEND AFTER GARDENING AND WE DID THIS IMAGING TEST, WE'D HAVE A TEMPTATION TO SAY, NO WONDER YOU'RE HAVING BACK PAIN WHEN INf‡ FACT THESE FINDINGS MAY BE YEARS OLD AND UNRELATED TO AN ACUTE EPISODE. SO, IN FACT, SCOTT, THE ORTHOPEDIC SURGEON WHO'S DATA I SHOWED YOU WROTE THIS. HE SAID A DIAGNOSIS BASED ON MRI IN THE ABSENCE OF CLINICAL OBJECTIVE FINDINGS MAY NOT BE THE CAUSE OF A PATIENT'S PAIN AND AN ATTEMPT TWOSHD OPERATIVE CORRECTION COULD BE A STEP TOWARDS DISASTER. COULD BIT THAT MRI ACTUALLY PROMPTS ILL ADVISED CLINICAL INTERVENTIONS? THERE ARE NOW SOME STUDIES, SOME VERY RECENT STUDIES THAT HAVE BEGUN TO ADDRESS THAT QUESTION. THE FIRST ONE HERE IS AN OBSERVATIONAL STUDY IN A WORKER'S COMPENSATION POPULATION TRYING TO LOOK AT WHAT HAPPENED TO PATIENTS IN THE WORKER'S COMP SYSTEM WHO GOT AN EARLY MR, WHICH MEANTśW@THIN THE FIRST SIX WEEKS, I BELIEVE, IN THE CASE, VERSUS PATIENT WHO IS HAD EITHER NO IMAGING OR LATER IMAGING BEYOND SIX WEEKS. THEY FOCUSED JUST ON LOW-RISK PATIENT WHO IS DID NOT HAVE RISK FACTORS FOR CANCER, INFECTION, AND THE LIKE. THEIR OBSERVATION WAS THAT PATIENT WHO IS RECEIVED EARLY MRI WERE SEVERAL TIME MRS. LIKELY TO UNDERSTOOD GO INJECTIONS AND SURGERY THAN PATIENTS WHO DID NOT GET THOSELY MRI. AGAIN, THERE'S A SELECTION PROBLEM HERE. EAR EARLY -- EARLY MRI. THEY TRIED TO ADJUST NONETHELESS FOR PAIN LEVELS AT THE TIME OF THE INITIAL VISITS, PAIN LEVEL, BASELINE FUNCTIONING, DEMOGRAPHIC CHARACTERISTIC AND SO FORTH. WHAT THEY FOUND WAS THAT THESE CASCADE EFFECTS SEEMED MORE STRONGLY ASSOCIATED WITH RECEIVING AN EARLY MR THAN WITH ANY PARTICULAR CLINICAL OR DEMOGRAPHIC FEATURES. THEN, IN SEATTLE, WE ACTUALLY UNDERTOOK A RANDOMIZED TRIAL WHERE WE INTERCEPTED PATIENTS WHO WERE BEING REFERRED TO THE RADIOLOGY DEPARTMENT FOR A PLAIN X-RAY OF THEIR SPINE. MOSTLY PRIMARY CARE PATIENTS. THEIR DOCTORS REFERRED THEM FOR A PLAIN X-RAY AND WE APPROACHED THEM IN RADIOLOGY WITH THE PRIMARY CARE PHYSICIAN'S PERMISSION AND SAID COULD WE RANDOMIZE YOU TO GO AHEAD AND GET YOUR X-RAY OR TO GET AN MRI? WE FOLLOWED THEM OUT FOR YEAR. WE FOUND THE GROUP WHO GOT THE MR ACTUALLY HAD MORE THAN TWOFOLD INCREASE IN THEIR SURGERY RATE OVER THE SUBSEQUENT YEAR BECAUSE THE NUMBERS WERE SMALL, THE DIFFERENCE WAS NOT%qr QUITE STATISTICALLY SIGNIFICANT BUT IT CERTAINLY LOOKED LIKE A POSSIBILITY THAT THE MRI FINDINGS WERE PROMPTING MORE INTERVENTION. WHEN WE E LOOKED AT OUTCOMES A YEAR LATER, THEY WERE ABSOLUTELY EQUIVALENT IN TERM OCHS PAIN AND FUNCTION. SO IT SEEMS THAT THE PATIENT WHO IS DID NOT GET MRs AND WHO HAD LESS SURGERY WEREN'T DISED Aw3 TEENAGING THEMSELVES WITH REGARD TO THEIR LONG-TERM OUTCOMES. DISADVANTAGING THEMSELVES. ULTIMATELY ASIDE FROM THIS CASCADE OF CLINICAL EVENTS THE REAL QUESTION IS DOES IT IMPROVE PATIENT OUTCOMES REGARDLESS OF WHAT THE MANAGEMENT HAS BEEN? WE HOPE THAT A DIAGNOSTIC TEST LEADS TO BETTER DIAGNOSIS, BETTER THERAPY AND THEREFORE BETTER OUTCOMES, AND IT TURNS OUT THAT THIS IS ONE OF THE RARE CASES, I THINK, WHERE THERE ACTUALLY ARE SOME RANDOMIZED TRIALS OF DIAGNOSTIC TEST. THESE ARE ARE RANDOMIZED TRIALS. WE FOUND SIX RANDOMIZED TRIALS OF PATIENTS WHERE THERE WAS AN AL MOE LOCATION TO EITHER AN IMAGING TEST OR TO NO IMAGING TEST. FOUR OF THEM WERE TRIALS OF PLAIN X-RAYS AND TWO OF MR OR CT. WHEN YOU LOOK AT ALL 06 THESE STUDY AND METAANALYZE THOSE THAT CAN BE, WHAT WE FOUND WAS THAT THERE WAS NO ADVANTAGE OF IMAGING IN THE SHORT OR LONG-TERM WITH REGARD TO PAIN, FUNCTION, QUALITY OF LIFE, MENTAL HEALTH, OR SATISFACTION WITH CARE. SO IT APPEARS THAT FROM THE BEST EVIDENCE WE HAVE THAT FOR LOW-RISK PATIENTS THE IMAGINGS IS ACTUALLY NOT IMPROVING SUBSEQUENT OUTCOMES. WELL, THEN THERE'S A QUESTION, COULD THE IMAGING ACTUALLY DO HARM? FOR EXAMPLE, BY LABELING PEOPLE AND MAKING THEM BELIEVE HEAR THE SICKER THAN THEY ARE? TWO OF THOSE RANDOMIZED TRIALS THEY JUST DESCRIBED ACTUALLY ADDRESSED THIS ISSUE IN SOME WAY. IN THE BRITISH RANDOMIZED TRIAL PATIENTS WERE RANDOMIZED TO GET A PLAIN X-RAY OR NOT. WHAT YOU SEE IS THAT AFTER THREE MOPTS THOSE WHO GOT X-RAYS REPORTED HIGHER LEVELS OF PAIN. THESE WERE SIGNIFICANT DIFFERENCES. THEY REPORTED LOWER OVERALL SELF-REPORTED HALE AND THEY WERE MORE LIKELY TO SEEK ADDITIONAL MEDICAL CARE DURING THEIR FOLLOW-UP. PARADOXICALLY, PERHAPS, THEY WERE ACTUALLY MORE SATISFIED WITH THEIR CARE, SEEMINGLY PLEASED THAT THEY GOT THE X-RAY BUT RECORD REPORTING WORST HEALTH OUTCOMES. THE SECOND STUDY WAS A STUDY OF LUMBAR MRI IMAGING. IN THIS CASE ALL OF THE PATIENTS GOT THE MR, BUT THEY WERE RANDOMIZED TO GET THE RESULTS OR NOT. IN FACT,–r SELF-RATED HEALTH IMPROVED SIGNIFICANTLY MORE IN THE PATIENTS WHO WERE BLINDED TO THEIR MRI RESULTS THAN THE FOLKS WHO WERE NOT. A SUGGEST HERE THAT PERHAPS LABELING EFFECTS MAY INFLUENCE HOW PEOPLE BEHAVE AND FEEL IN WAYS THAT ARE NOT HELPFUL. OF COURSE, THERE'S ALSO THE POTENTIAL RISK OF RADIATION EXPOSURE. THIS IS MAINLY AN ISSUE FOR LUMBAR CT SCANNING. AND THE RISKS ARE SMALL BUT NOT ZERO. THERE ARE TWO STUDIES JUST INv: THE PAST YEARS THAT HAVE TRIED TO ADDRESS THIS. WE CAN ESTIMATE THE AVERAGE RADIATION DOSE FROM A LUMBAR CT, ESTIMATE THE NUMBER OF LUMBAR CT SCANS DONE IN THE U.S. IN THE PARTICULAR YEAR AND THEN TRY TO ESTIMATE THE FUTURE BURDEN OF CANCERS THAT ARE ATTRIBUTABLE TO THATv: IMAGING PROCEDURE. SO MAYBE 1,200 FUTURE CANCERS A YEAR AS A RESULT OF LUM/SPINE CT SCANS. THE PROBLEM FOR US AS CLINICIANS, OF COURSE, IS HOW TO BE BOTH EVIDENCE-BASED AND PATIENT-CENTERED. CLINICIANS ARE CONCERNED ABOUT PATIENT, AND PATIENTS MAY BE HAPPIER WHEN THEY GET IMAGING TESTS. CLINICIANS ARE ALSO CONCERNED ABOUT MEDICALŤ RISKS OF MISSING SOMETHING AND THERE ARE STRONG PRESSURES CONTRARY TO THE EVIDENCE OF THE SORT THAT I'VE SHOWN YOU HERE. PATIENTS REALLY WANT MECHANICAL EXPLANATIONS FOR THEIR PAIN. THEY PUT A HIGH VALUE ON VISUAL, EVIDENCE, AND CONCERNS ABOUT LABELING OR COSTS OF CARE JUST DON'T RESINATE WITH MOST PATIENTS. THAT'S NOT SOMETHING THAT'S ON THEIR MINDS. SO IN A SURVEY OF PRIMARY CARE CLINICIANS, IT TURNS OUT THAT OVER A THIRD OF PHYSICIANS REPORTED THAT THEY WOULD INDEED ORDER AN MR FOR A PATIENT THAT HAD JUST TWO DAYS OF ACUTE LOW BACK PAIN, A FIRST EPISODE THAT-9 STARTED WHILE THEY WERE WORKING AROUND THE HOUSE IF THE PATIENT WAS INSISTENT ENOUGH EVEN AFTER EXPLAINING THAT THE TEST WAS UNNECESSARY. SO THIS IS THE CHALLENGE THAT I THINK WE REALLY HAVE TO DEAL WITH IN TERMS OF ACTUAL CLINICAL PRACTICE. WELL, THE AMERICAN PAIN SOCIETY AND THE AMERICAN COLLEGE OF PHYSICIANS, AGAIN, WORKED TOGETHER ON A SET OF IMAGING GUIDELINES FOR LOW BACK PAIN AND THEY ACTUALLY CONCLUDED THAT WE SHOULD NOT BE DOING ANY ROUTINE IMAGING OR DIAGNOSTIC TESTS FOR PATIENT WHO IS HAVE NON-SPECIFIC LOW BACK PAIN. MEANING PATIENT WHO IS DON'T HAVE RISK FACTORS FOR SOME OF THESE SYSTEMIC DISEASES UNDERLYING OR MAJOR NEUROLODGE LOGIC DEFICITS. YOU DO WANT TO IMAGE IF A PATIENT HAS A MAJOR RISK OF CANCER CAUSING THE BACK PAIN OR IF THEY HAVE PROGRESSIVE NEW LOGIC DEFICITS. THEY SAID BEYOND THAT YOU WOULD WANT TO IMAGE AFTER A HERE TO PEW TICK TRIAL IF PATIENTS AREN'T GETTING BETTER, AND IF THEY HAVE RISK FACTORS FOR COMPRESSION FRACTURES OR [INDISCERNIBLE] OR STENO SIS OR MORE MINOR RISK FACTORS FOR CANCER. THEY ALSOkO RECOMMENDED AGAINST DISCOG FI, ANOTHER TYPE OF IMAGING TEST THAT I HAVEN'T DESCRIBED, BUT IN DISKkO GRAM YOU INJECT CONTRAST MATERIAL IN INTO THE DISK, ITSELF, AND IT'S BOTH A PROVOCATIVE TEST IN THAT IT'S INTENDED TO REPRODUCE THE PATIENT'S PAIN AND AN IMAGING TEST IN THAT IT DEMONSTRATES THE DISRUPTION OF THE DISK, BUT A TEST THAT REMAINS CONTROVERSIAL AND FOR WHICH THE EVIDENCE OF IMPORTANT DISCRIMINATORY ABILITY BETWEEN PEOPLE WHO DO AND DON'T BENEFIT FROM SURGE VI REALLY LACKING. SURGERY IS REALLY LACKING. I HAVEN'T TALKED ABOUT WHAT DOES WORK FOR PEOPLE WHO HAVE BACK PAIN AND WHAT THE EARLY MANAGEMENT MIGHT INCLUDE OR THE NON-SURGICALoMANAGEMENT, UH BUT I MIGHT JUST POSE A SIMPLE SUMMARY HERE. FIRST OF ALL, FOR ACUTE BACK PAIN IT TURNS OUT TO BE HARD TO IMPROVE ON THE NATURAL HISTORY BECAUSE MOST PEOPLE GET BETTER AND FAIRLY RAPIDLY. THAT'S NOT NECESSARILY TO SAY THEY BECOME PAIN FREE, BUT THEY HAVE SUBSTANTIAL IMPROVEMENT WITHIN THE FIRST FEW WEEKS IN THE VAST MAJORITY OF CASES. I THINK IT'S IMPORTANT FOR US TO PERSUADE PATIENTS THAT THEY'RE NOT FRAGILE. TO ADDRESS WORK ISSUES IF POSSIBLE SO THAT THEY'RE ABLE TO RETURN TO WORK, AND AS WE'VE JUST DISCUSSED, USE IMAGING IN A HIGHLY-SELECTIVE FASHION. I HAVEN'T SHOWN YOU THE EVIDENCE, BUT THERE ARE DECENT RANDOMIZED TRIALS SUGGESTING THAT STEROIDAL DRUGS ARE USEFUL FOR PATIENTS WITH BACK PAIN. SPINAL MANIPULATION HAS TREATMENT EFFECT VERY SIMILAR TO THAT OF MEDICATIONS AND NON-SURGICAL CONVENTIONAL MEDICAL CARE, AND I THINK THE OPIOIDS SHOULD BE A SECOND CHOICE AND NOT A FIRST CHOICE FOR MOST OF THESE PATIENTS. ACTIVATION AND EXERCISE ARE REALLY THE MAIN STAYS FOR CHRONIC BACK PAIN IN MY MIND. AGAIN, I HAVEN'T SHOWN YOU THE EVIDENCE FOR THAT, BUT THERE ARE SOME RANDOMIZED TRIALS THAT HAVE ADDRESSED EXERCISE AS THERAPY FOR LOW BACK PAIN. ANTIDEPRESSANT THERAPY, I THINK, I'M CONVINCED, IS PERHAPS WORTH A TRY FOR PATIENTS WITH CHRONIC LOW BACK PAIN. THE OLD FASHIONED ANTIDEPRESSANTS MAY ACTUALLY BE MORE EFFECTIVE IN THIS REGARD THAN THE NEWER SSRIs. IT CERTAINLY ALSO TRUE THAT CHRONIC PAIN AND DEPRESSION FREQUENTLY COEXIST. THAT'S ANOTHER REASON TO CONSIDER ANTIDEPRESSANT THERAPY. FINALLY, FOR PATIENT WHO IS JUST REALLY AREN'T GETTING BETTER DESPITE ALL EFFORT, MULTIDISCIPLINARY PAIN CENTER DOS HAVE SOMETHING TOmy OFFER, AND TYPICALLY THE MOST EFFECTIVE COMPONENTS OF THAT CARE APPEAR TO BE COGNITIVE BEHAVIORAL THERAPY, PATIENT EDUCATION, AND SUPERVISED EXERCISE PROGRAMS. SO I THOUGHT THAT I WOULD SHOW YOU AN INTERESTING STORY HERE ABOUT HOW ONEkO MIGHT PROMOTE THAT SORT OF A TREATMENT AGENDA AND TRY TO DEMEDICALIZE BACK PAIN TO SOME DEGREE BY SHOWING YOU DATA FROM A PUBLIC MEDIA CAMPAIGN THAT WAS UNDERTAKEN IN AUSTRALIA, THE STATE OF VICTORIA IN AUSTRALIA WAS FACING RAPIDLY-RISING DISABILITY COST OF WHICH HALF WERE DUE TO LOW BACK PAIN. SOMEONE IN THE GOVERNMENT CONCEIVED OF THE IDEA OF MOUNTING A PRIME TIME TV CAMPAIGN WHICH WAS FAIRLY INTENSIVE FOR A FEW MONTHS THEN LOWER LEVEL THEN A BOOSTER DOSE OF TV ADS AFTER A YEAR. THEY HAD MEDICAL EXPERTS AND SPORTS STARS AND MEDIA PERSONALITIES WHO APPEARED ON THESE SPOTS, AND EACH ONE WAS ENDORSED BY A RELEVANT MEDICAL SOCIETY. THE MESSAGE WAS TO%q EMPHASIZE PHYSICAL ACTIVITY AND AVOIDING BEDREST AND POINTING OUT SOME OF THE HAZARDS OF MEDICAL TESTS AND SURGERY. I FELT WHAT I WOULD DO WAS SHOW YOU COUPLE OF THESE. THEY'RE 30-SECONDS SPOTS AND THEY'RE MORE ENTERTAINING THAN MY MESSAGE WOULD BE AND WE'LL GIVE YOU A SENSE OF WHAT THIS CAMPAIGN CONSISTED OF. SOd8 LET ME SEE IF I CAN DO THAT. >> ONE OF THE MOST FRUSTRATING THING ABOUT BACK PAIN IS THAT WE CAN'T ALWAYS FIX IT. IF YOU HAVE X-RAYS THEY'LL DEMONSTRATE SIGNS OF WEAR AND TEAR AND YOU MIGHT BE TOLD TO STOP AXTIVITIES. WHAT THE X-RAY'S SHOWING MIGHT NOT BE THE CAUSE OF THE PAIN. X-RAYS DON'T SHOW PAIN, NO TEST KA K. SO BEFORE YOU ACCEPT ADVICE THAT COULD CHANGE YOUR LIFE, GET ANOTHER OPINION. I WOULD. >> ENDORSE BRID THE -- >> CANi] YOU HEAR THAT OKAY? >> THE SECOND ONE HERE HAS TO DO WITH THE BENEFITS OF EXERCISE.THE SECOND O NE HERE HAS TO DO WITH THE BENEFITS OF EXERCISE. >> YOU KNOW, THEY SAY WE SHOULD NEVER WALK AWAY FROM OUR PROBLEMS, BUT I DID. I WALKED AWAY FROM A NEGATIVE ATTITUDE THAT MY BACK WOULDN'T GET BETTER. WALKING STRENGTHENED MY BACK AND HELPED EASE THE PAIN, AND THIS LET ME WALK AWAY FRA MY PAINKILLERS. >> AFTER YOU'VE HAD IT CHECKED OUT, GENTLE EXERCISE CAN HELP YOUR BACK PAIN. >> FIRST OF ALL I WALKED BACK INTO MY JOB AND MY LIFE. >> ENDORSED BY THE OCCUPATIONAL MEDICINE. >> AND THEN THE THIRD ONE HERE I'M GOING TO DESCRIBE THE START OF THIS BECAUSE I HAVE A HARD TIME UNDERSTANDING THE AUSTRALIAN ACCENT HERE, BUT THE O TALKING ABOU T GUY STARTS OFF B GETTING A TROLLY FOR JOE TO SAVE HIM FROM LIFTING THINGS FROM THE FLOOR AT HIS JOB. SO LET'S START THIS ONE. >> GOOD IDEA GETTING JOE BACK TO WORK. >> VERY GOOD IDEA. >> PUTTING IN THOSE TROLLIES SO HE DIDN'T HAVE TO BEND WITH HIS BAD BACK. >> GREAT IDEA. >> PARTS ARE MOVING FASTER. >> BRILLIANT. >> DON'T HAVE TO TRAIN. >> YOU'VE REDUCED YOUR CLAIM COST AND -- >> WHY DIDN'T I THINK OF THIS EARLIER? >> BECAUSE I HADN'T SUGGESTED IT EARLIER. >> ONE OF MY BETTER IDEAS. >> YEAH. YOU ARE A GENIUS. >> THE CAMPAIGN ACTUALLY HAD AN EFFECT. THERE'S A RHEUMATOLOGIST IN MELBOURNE, WHO ACTUALLY UNDERTOOK A FAIRLY RIGOROUS EVALUATION OF THIS CAMPAIGN AND WHAT THEY WERE ABLE TO DEMONSTRATE WAS FOLLOWING THIS CAMPAIGN THERE WAS A 15% DROP IN THE ABSOLUTE NUMBER OF BACK-RELATED CLAIMS A ANDi] 20% DECREASE IN MEDICAL COSTS PER CLAIM, AND THEY DID -- OOPS, IF I CAN BACK UP HERE. THEY DID SOME RANDOM TELEPHONE SURVEYS OF BOTH THE PUBLIC AND OF PHYSICIANS. THEY REALIZED THAT THIS WAS A STEALTH CAMPAIGN FOR REEDUCATING PHYSICIANS AS WELL ABOUT SOME OF THE ISSUESzV RELATED TO BACK PAIN. WHAT THEY DESCRIBED WAS A SIGNIFICANT IMPROVEMENT OF PHYSICIAN KNOWLEDGE ABOUT THE LIMITS OF BEDREST AND IMAGING. IN VICTORIA, CHANGES WERE GREATER THAN IN SOUTH WAEL, WALES. NOW, LET ME SHIFT FINALLY TO TALK ABOUT SURGERY HERE IN THE LAST COUPLE OF MINUTES. WHEN I WAS A MEDICAL STUDENT, I ONLY LEARNED ABOUT BACK SURGERY WHEN I TOOK AN ORTHOPEDIC ROTATION AND IT SEEMED TO ME THAT THE SURGEONS SOMEHOW KNEW WHO TO OPERATE ON AND WHO NOT. UH BUT IN FACT, LIKE MANY OTHER SURGICAL PROCEDURES IT TURNS OUT THERE ARE A WIDE GEOGRAPHIC VARIATIONS IN HOW BACK SURGE ARE RI GETS USED. THIS MAP IS FROM DART MOTH ATLAS. THE LIGHT AREAS ARE LOW SURGICAL RATES AND THE DARKEST COLORS LIKE OURS IN WASHINGTON STATE AND OREGON, VERIER HIGH SURGICAL RATES. THE DIFFERENCES BETWEEN THE HIGH AND LOW RATE AREAS ARE WHAT, SIX FOLD, SOMETHING LIKE THAT. PROBABLY EVERYONE CAN COME UP WITH A HYPOTHESIS FOR WHY THESE DIFFERENCES MIGHT EXIST. THE BEST HYPOTHESIS WOULD BE THAT WE SIMPLY HAVE WEAKER SPINES AND MORE HERNIATED DISKS OUT WEST THAN ON THE EAST COAST, BUT–rŤ EPIDEMIOLOGIC STUDIES ACTUALLY DON'T SERGEANT THAT THAT'S THE CASE. I THINK, IN FACT, YOU HAVE TO LOOK BEYOND SIMPLE BIOLOGICAL EXPLANATIONS FOR THESE DIFFERENCES. YOU'LL SEE SOME[ OF THE VERY LOW-RATE AREA, NEW YORK, MASSACHUSETTS, NEW ENGLAND, OUR HEAVILY-POPULATED AREAS IN AREAS WE WOULDN'T THINK OF AS BEING MEDICALLY UNDERSERVED. WHAT IS THE NEED FOR SPRIEN SURGERY? THE NEED IS RELATIVELY SMALL. IT PROBABLE DEALS WITH PATIENT WHO IS HAVE MAJOR NEUROLOGIC DEFICITS AND CERTAIN CASES OF FRACTURE AND TUMOR AND INFECTION. BEYOND THAT, IT REALLY IS AN ELECTIVE PROCEDURE. PART BECAUSE OF DATA LIKE THIS. I HAVE TO REMIND MY PRIMARY CARE COLLEAGUES THAT IN FACT, PATIENTS WITH HERNIATED DISKS CAN GET BETTER WITHOUT SURGERY. MANY OF THEM DON'T REALIZE THAT, BUT THESE ARE DATA FROM A RANDOMIZED TRIAL. THIS ONE DONE IN HOLLAND, FOR PATIENT WHO IS HAD A HERNIATED DISK WITH SCIATIC. WITH SURGERY, LEG PAIN LEVELS FELL DRAMATICALLY AND THEN LEVELLED OFF. FOR THE NON-SURGICAL PATIENTS, LEG PAIN LEVELS ALSO FELL -- NOT AS FAST, BUT BY A YEAR, THESE TWO CURVES ACTUALLY CONVERGED AND PATIENTS WERE AT ROUGHLY THE SAME PAIN LEVEL. THERE HAVE BEEN OTHER RANDOMIZED TRIALS WITH VERY SIMILAR RESULTS SUGGESTING SOME SORT OF CONVERGENCE AT A YEAR OR TWO YEARS OR FOUR YEARS OR SOME PERIOD OF TIME, BUT NEARLY ALL OF THEM SHOW A SIMILAR PATTERN. SO PATIENTS NEED TO UNDERSTAND THAT, IN FACT, THERE IS A FAVORABLEś I WOULD ARGUE THAT SOME PATIENTS MIGHT LOOK AT THIS AND SAY, WOW, IF THERE'S A CHANCE THAT SURGERY'S GOING TO MAKE ME BETTER FASTER, I WANT IT TOMORROW BECAUSE THIS IS DRIVING ME CRAZY AND I CAN'T WORK AND I CAN'T THINK AND I DON'T WANT TO LIVE ANOTHER DAY LIKE THIS, AND THERE MIGHT BE OTHER PATIENT WHO IS LOOK AT THESE DATA AND SAY, – I CAN GET BETTEREN OH, I SEE, IF WITHOUT SURGERY, SURGICALLY SCARES ME TO DEATH, I DON'T WANT ANYBODY MESSING AROUND IN MY BACK, I CAN TOUGH THIS OUT FOR LITTLE WHILE LONGER. I THINK I'LL PASS, THANK YOU VERY MUCH. I THINK THEY'RE BOTH RIGHT. THOSE ARE BOTH RATIONALŤ RESPONSES. WHO SHOULD WE CONSIDER FOR ELECT TI SURGERY? I THINK WE'VE GOT GOOD EVIDENCE FROM CLINICAL TRIALS TO SUGGEST THAT PATIENTS WITH HERNIATED DISKS, SPINAL STENO SIS CAN BENEFIT FROM SURGERY AND ALL OF THOSE CLINICAL TRIALS THE PATIENTS WHO WERE ENROLLED HAD BOTH LEG PAIN AND BACK PAIN. THAT'S WHERE WE HAVE THE BEST EVIDENCE. IN ADDITION, PATIENTS SHOULD HAVE A POOR RESPONSE TO CONSERVATIVE THERAPY SINCE MANY WILL GET BETTER. YOU'D LIKE TO BE SURE THAT THE HISTORY AND PHYSICAL EXAM AND IMAGING IS RESULTS ARE CONSISTENT BECAUSE YOU DON'T WANT TO BE OPERATED ON SOMEONE WHO HAD A LEFT SIDE HERNIA AND RIGHT SIDE DISK. I THINK PATIENTS NEED TO UNDERSTAND THE BENEFITS AND RISKS OF SURGICAL AND NON-SURGICAL OPTIONS THAT THEY FACE. FUSION FOR LUMBAR DEGENERATED DISK IS REALLY THE MOST CONTROVERSIAL INDICATION AND DISAPPOINTEDLY IT'S THE MOST COMMON INDICATION FOR LUMBAR SPINE FUSION AS OF 2008, IT'S BEEN INCREASING RECENTLY. IN FACT, THE USE OF LUMBAR SPINE FUSIONS HAS INCREASED DRAMATICALLY OVER THE PAST TEN YEARS AND MORE THAN OTHER TYPES OF SURGERY. AGAIN, THE TEN-YEAR INCREASE ROUGHLY IN THE NATIONAL BILL FOR SPINE FUSIONS IS OVER 600% AND THAT'S THE CONSEQUENCE OF BOTH INCREASING FREQUENCY OF SURGERY AND INCREASING COST OF SURGERY. THE INCREASING COST IS AT LEAST IN PART RELATED TO INCREASING USE OF INSTRUMENTATION AND VARIOUS TYPES OF INPLANTS IN SURGERY. I WON'T GO THROUGH IT IN DETAIL, BUT THESE ARE STUDY DEMONSTRATE A DRAMATIC INCREASE IN INSTRUMENTED + THAN ALL SPINE AND SURGERY IN THE LUMBAR SPINE. -- NO DIFFERENCE IN THE REPORTED RATES O OF SUCCESSFUL BONY FUSION OR IN CLINICAL OUTCOMES. SO ONCE AGAIN, THERE ARE SOME IMPORTANT FINANCIAL INTERESTS THAT PLAY A ROLE HERE. THESE PED CALL SCREWS, AS THEY'RE KNOWN, ON AVERAGE ADD ABOUT $13,000 TO THE COST OF AN OPERATION. THE MARKET IN THE U.S. IS SEVERAL BILLION DOLLARS AND MANUFACTURERS HAVE ACKNOWLEDGED GIVING SURGEONS MILLIONS OF IN ROYALTY PAYMENTS AND RESEARCH GRANTS RELATED TO THESE ADVICES. ONE COMPANY PAID Au!Ť $40 MILLION SETTLEMENT BACK IN 2006, WITHOUT ACKNOWLEDGING ANY WRONG DOING, BUT THERE ARE ONGOING INVESTIGATIONS OF COMPANIES AND SURGEONS. THE LATEST TREND IS FOR SURGEONS TO FORM THEIR OWN COMPANIES THAT MAKE THE SCREWS SO THAT THEY CAN'T BE AFUSED OF KICKBACKS FROM SOMEONE ELSE. IT'S THEIR OWN BUSINESS, AFTER ALL. PROFITS FROM THE HARDWARE COME DIRECTLY TO THEM RATHER THAN BEING SPLIT. HOW EFFECTIVE THE SPINAL FUSION SURGERY FOR LOW BACK PAIN; PATIENT WHO IS DON'T HAVE SCIATICA OR LEG PAIN? THERE HAVE BEEN -- THESE ARE DATA FROM AN=) AHRQ LITERATURE SYNTHESIS DONE IN 2006 AND STILL IN DRAFT FORM. THEY ALSO ARGUE THAT THE INSTRUMENTATION AUGMENTS THE SUCCESSFUL BONY FUSION RATE BY A FEW PERCENT BUT WITH THE COST OF HIGHER COMPLICATIONS AND NO CLEAR ADVANTAGE WITH REGARD TO PAIN RELIEF OR FUNCTIONAL IMPROVEMENT. THEY'RE CONCLUSION WZ WAS THAT CONCLUSION FOR DISK DISEASE REALLY HAS NO CONCLUSIVE ADVANTAGE OVER THE SHORT-TERM OR LONG-TERM. WITH RAPID INCREASES IN IMAGING, IN OPIOID USE, IN SURGERY AND INJECTIONS, YOU MIGHT REASONABLY EXPECT THAT OVERTIME THE POPULATION OF THE U.S. WOULD BE HAVING LESS DYSFUNCTION RELATED TO BACK PAIN AND PERHAPS LOWER RATES OF REPEAT SPINE SURGERY AS A RESULT OF ALL THIS NEW TECHNOLOGY. HOWEVER, WHEN YOU LOOK AT DATA FROM A NATIONAL SURVEY -- THIS IS THE MEDICAL EXPENDITURE PANEL SURVEY -- THESE ARE NOT THE SAME PATIENTS FOLLOWED OVER TEN YEARS, BUT THESE ARE REPEATED CROSS SECTIONAL PATIENT WHO IS REPORT HAVING BACK PAIN. IN THIS SURVEY THEY ACTUALLY ASK A SERIES OF FUNCTIONAL STATUS QUESTIONS, AND WHAT YOU SEE HERE IS THAT OVERTIME, PATIENTS WITH BACK PAIN ARE REPORTING MORE-9 PHYSICAL FUNCTION LIMITATIONS, MORE ACTIVITY LIMITATIONS WITH REGARD TO WORK, MORE SOCIAL LIMITATIONS, MORE LIMITATIONS AND ACTIVITIES OF DAILY LIVING. ON A POPULATION LEVEL, AT LEAST, PEOPLE SEEM TO BE MORE DISABLED BY BACK PAIN THAN THEY WERE TEN YEARS AGO RATHER THAN LESS. IF YOU LOOK AT WHAT'S HAPPENING REGARDING REPEAT SPINE SURGERY, WHAT YOU SEE HERE ARE DATA FROM STUDY WE DID IN WASHINGTON STATE LOOKINGi# SURGERY IN THE EARLY 1990s COMPARED TO THE LATE 1990s. WE DOCUMENTED THAT IN FACT THIS LATE # 0s SERVE HAS A MUCH HIGHER PERCENTAGE OF SPINAL FUSION OPERATIONS. WHAT YOU SEE IS THAT IN FACT THE REPEAT SURGERY RATE IS ACTUALLY HIGHER IN THE LATE 90s THAN IT WAS IN THE EARLY 90s; THE OPPOSITE OF WHAT YOU MIGHT HOPE FOR IN THE FACE OF MORE INTENSIVE INTERVENTION. MY QUICK SUMMARY IS THAT I WOULD ARGUE THAT PRECISE DIAGNOSIS IS OFTEN IMPOSSIBLE WITH BACK PAIN EVEN WITH MODERN IMAGING WHICH MAY IN TURN DRIVE UNNECESSARY SURGERY. I THINK EARLY EXERCISE AND/OR EARLY ACTIVATION AND EXERCISE ARE REALLY THE MAINSTAYS FOR CHRONIC PAIN. LONG-TERM OPIOIDS I THINK WE HYV ROLE IN LONG-TERM MANAGEMENT. WIDE VARIATIONS IN SURGE RAL KRA PRACTICE, THERE SEEMS TO BE A LIMITED CONSENSUS ON THE OPTIMAL USE OF SURGERY AND ITS OUTCOMES. IT APPEARS THAT OVER THE PAST DECADE INCREASINGLY INTEN SI THERAPY HASN'T RESULTS IN BETTER OUTCOMES FOR PATIENTS BUT WE COULD CERTAINLY DEMONSTRATE HIGHER COMPLICATION RATES FROM SEVERAL OF THESE INTERVENTIONS. THE PROGNOSIS FOR ACUTE BACK PAIN IS GENERALLY VERY FAVORABLE AND PATIENTS NEED THAT REASSURANCE. SO I THINKŤ MARK TWAIN HAD IT RIGHT. IN MANY CASES WE'VE BEEN GUILTY OF SUPPOSING SOMETHING WORKS BUT FINDING OUT IS BETTER. THANKS VERY MUCH.