I WANT TO INTRODUCE HENRIK SORENSEN, WHO WILL TELL US AN EXCITING STORY ABOUT HOW HE'D OPENED UP A WHOLE COUNTRY'S CLINICAL DATA AND DATABASES FOR USE IN CLINICAL RESEARCH. THIS IS VERY EXCITING. HE SAW THE VALUE OF CLINICAL DATABASES FROM HIS WORK WITH DR. JIK IN BOSTON BACK IN 1991, WHO HAD A GREAT BIG DATA SURVEILLANCE DATABASE, HE SAID WHY STOP WITH DRUGS. HE CAME BACK TO DENMARK AND ABOUT TWO YEARS LATER, 1994, STARTED BUILDING THIS WHOLE NETWORK OF DATABASES AND INFORMATION SOURCES, AND IT'S OVER THE YEARS HE GATHERED POLITICAL -- FACILITATED THE CREATION OF MANY SPECIAL REGISTRIES, TAPPED INTO MEDICAL RECORDS DATA AND CONNECTED IT ALL. IT'S A MAGNIFICENT THING. IT'S WHAT EVERY RESEARCHER WOULD DREAM OF. MY INVITATION, EVEN THEN IT'S SUCH AN EXCITING DEVELOPMENT, KIND OF WHAT EVERY LARGE COUNTRY OR REGION SHOULD DO. SO HE'S A LITTLE DETAIL, HE'S AB INTERNIST, HE PRACTICED FOR MANY YEARS, HE DIDN'T HAVE TIME FOR THE LAST SOME YEARS, HE'S AN EPIDEMIOLOGIST, AND HE'S HEAD OF THE DEPARTMENT OF CLINICAL EPIDEMIOLOGY AT AARHUS UNIVERSITY WHICH IS THERE UP ON THE MAP. HE SUPERVISED MORE THAN 45 GRADUATE STUDENTS THROUGH THEIR -- SHEPHERDED THEM THROUGH THEIR PH.D., HE PUBLISHED A PRESTIGIOUS NUMBER OF PAPERS. THE NUMBER IS ACTUALLY ASTOUNDING. UPWARD OF 800. I KEEP COUNT OF MY PAPERS AND OTHER PEOPLE'S PAPERS, THAT'S A GOOD NUMBER. HE SERVED AS EDITOR-IN-CHIEF OF THE JOURNAL EPIDEMIOLOGY AND HE'S RECEIVED MANY HONORS INCLUDING HE'S A KNIGHT, NOT IN ENGLAND AT THE ROUNDTABLE BUT A KNIGHT OF THE QUEEN OF DENMARK, ACTUALLY IT'S THE ORDER OF DENEBOURG, IF I GOT THAT RIGHT. SO WE WANT TO HEAR YOUR STORY IN YOUR OWN WORDS, AND EVERYONE IS EXCITED ABOUT IT AS I AM. WELCOME. [APPLAUSE] >> THANK YOU VERY MUCH FOR INVITING ME TO COME HER HERE TO TALK ABOUT A LITTLE COUNTRY IN EUROPE. IT'S A PLEASURE TO BE HERE. THE TITLE OF THIS TALK IS WHEN THE ENTIRE COUNTRY IS A COHORT, AND IT IS FROM THE -- I'M FROM A CITY CALL OF 300,000 PEOPLE. I HAVE DIVIDED THIS TALK INTO FOUR SECTIONS. THE HISTORY OF THE DATABASES, THEN SOME OF THE MEDICAL DATABASES IN DENMARK AND I WILL ALSO GIVE YOU AN EXAMPLE OF THE BIOBANKS, THEY HAVE A HUGE POTENTIAL FOR LONGITUDINAL STUDIES IN THE FUTURE, AND THEN I WOULD SAY SOMETHING ABOUT THE ACCESS TO DATA AND THE CHALLENGES OF THE DATABASES IN DENMARK. DENMARK IS A SMALL COUNTRY, 5.5 MILLION, GERMANY, SWEDEN AND NORWAY. SOME YEARS AGO, WE HAD A -- FROM WASHINGTON, SHE SAID SHE WAS REALLY EXCITED OF BEING IN COPENHAGEN, THEN SHE POINTED OUT STOCKHOLM AND SWEDEN, THE ROYAL FAMILY PLAYS A ROLE TO THESE REGISTRIES, AND HERE YOU HAVE THE QUEEN, HER HUSBAND, AND THE CROWN PRINCE AND CROWN PRINCESS, AND IT'S A SPECIAL DAY TODAY BECAUSE THE HUSBAND, HE TURNED 79 TODAY. I HE HAS A METABOLIC SYNDROME. HE IS A NICE MAN. HE HAS BEEN IN DENMARK FOR THE LAST 40 YEARS AND HERE IS THE FORMER KING. HE WAS VERY POPULAR AS UH-UH CAN SEE, HE WAS REALLY A SAILOR, SO THE ROYAL FAMILY IS THE OLDEST MONARCHY IN THE WORLD. THE QUEEN HAS ACTUALLY BEEN MENTIONED IN A PAPER SOME YEARS AGO, WOMEN IN DENMARK, THEY HAVE THE HIGHEST MORTALITY IN EUROPE AND EPIDEMIOLOGISTS FROM BELGIUM POINTED OUT THAT THERE COULD BE A LINK BETWEEN THE QUEEN'S SMOKING HABITS AND THE MORTALITY AMONG DANISH WOMEN. ACTUALLY SHE WAS MENTIONED IN THIS PAPER HERE AND THE GRAPH SHOWN IN ASSOCIATION. SHE SMOKES A LOT, SHE IS STILL 73, AND SHE IS NOT ABLE TO GET LEGAL CIGARETTES IN DENMARK SO SHE GETS THEM FROM THE -- PART OF EUROPE. SO THE DANES ARE THE HAPPIEST PEOPLE IN THE WORLD, AND THAT'S PROBABLY ONE OF THE REASONS WE ARE ABLE TO USE THESE DATA WITHOUT A LOT OF TROUBLE. AND THIS IS FROM A TABLE PUBLISHED SOME YEARS AGO, THEY MADE A STUDY THEY WOULD EXAMINE WHY THE DANES WERE SO HEAVY. YOU CAN SEE DENMARK, YOU CAN SEE MANY OF THE OTHER COUNTRIES, AND UH-UH SEE DENMARK HAS A VERY HIGH LEVEL OF HAPPINESS, AND SOMETHING HAPPENED HERE AROUND '91 AND '92, AND AT THAT TIME DENMARK FOR THE FIRST AND ONLY TIME WON THE EUROPEAN CHAMPIONSHIP, SO ACTUALLY THE RESEARCH, THEY SAID THERE MUST BE A LINK BETWEEN THESE TWO -- BETWEEN THIS CHAMPIONSHIP AND THE PREVALENCE OF HAPPINESS IN THE DANISH POPULATION. BUT WHY DOES THE ROYAL FAMILY HAVE ANY ASSOCIATION WITH THE REGISTRIES? THE REGISTRIES WERE ESTABLISHED BECAUSE OF THE CHURCH AND BECAUSE OF THE ROYAL FAMILY, BECAUSE THEY COLLECT A TAX, AND YOU KNOW THEY PAY AROUND -- TAX IN DENMARK. IF YOU RILEY WANT TO HAVE TAX, THEN YOU NEED TO CONTROL THE POPULATION. ALREADY HERE IN THE 45, THE -- WERE ESTABLISHED. AT THE SAME TIME, WHEN THE UNITED STATES WAS ESTABLISHED, THE FIRST -- TOOK PLACE IN DENMARK. ALSO THE FIRST -- AROUND 250 YEARS AGO, AND THEN IN DENMARK, WE GOT THE REAL POPULATION REGISTRY IN 1924. THEN WE GOT SEVERAL OTHER DISEASE REGISTRIES. I WILL MEN SER THE CANCER REGISTRY, WHICH WAS ESTABLISHED DURING THE SECOND WORLD WAR, AS FAR AS I KNOW BASED ON MONEY FROM THE NATIONAL CANCER INSTITUTE IN THE UNITED STATES. ALSO I WOULD LIKE TO MENTION THE PSYCHIATRIC REGISTRY, WHICH IS ONE OF THE ONLY PSYCHIATRIC REGISTRIES IN THE WORLD, IT HAS A VERY HIGH DATA -- BUT A STEP FORWARD WAS REALLY THE ESTABLISHMENT OF THE CIVIL REGISTRATION SYSTEM IN '68, AND IT WAS ESTABLISHED AGAIN BECAUSE OF TAX PURPOSES. SO HERE ARE THE MILESTONES, THE COLLECTION -- WHAT DO YOU CALL IT WHEN THEY -- A REGISTRATION OF THE TOTAL POPULATION MANY HUNDRED YEARS AGO AND THEN AGAIN IN APRIL '68. SO WHEN WE'RE TALKING ABOUT MEDICAL DATABASES AND MEDICAL REGISTRIES IN DENMARK, WE IN GENERAL DIVIDE THEM UP INTO THREE GROUPS, CLASSIC MEDICAL REGISTRIES, ADMINISTRATIVE DATABASE AND A NEW CONCEPT CALLED CLINICAL QUALITY DATABASES. I'LL HAVE PROVIDED SOME EXAMPLES HERE. THE CLASSICAL MEDICAL REGISTRY REGISTRY -- THE PRESCRIPTION DATABASE, AND THE -- THE TROAK DATABASE AND THE GENERAL PRACTICE DATABASE IN DENMARK. SO THESE DATABASES, THEY HAVE VERY HIGH DATA QUALITY COMPARED TO MANY OTHER DATABASES ALL OVER THE WORLD, AND THIS WAS MENTIONED IN THIS PAPER, PUBLISHED IN THE YEAR 2000 IN "SCIENCE" WHERE THEY WROTE ABOUT THIS CIVIL REGISTRATION SYSTEM AND DESCRIBED IT AS A COHORT. IT IS REALLY A COHORT AND THIS CIVIL REGISTRATION SYSTEM WAS REALLY A STEP FORWARD FOR MEDICAL RESEARCH. SO WHY IS DENVER A COHORT? IT IS BECAUSE OF THIS CIVIL REGISTRATION SYSTEM ESTABLISHED IN '68 AND IT MEANS THAT WE CAN CONTROL EVERYTHING IN THE POPULATION. THERE IS A LONG TRADITION FOR REJ STATION IN DENMARK. IN -- REGISTRATION IN DENMARK. WE RECORD EVERYTHING. AND THEN WE HAVE A PUBLIC HEALTHCARE SYSTEM THAT CAPTURES ALL MAJOR DISEASES IN THE POPULATION. SO IF YOU COMBINE THESE TREE -- THE CIVIL REGISTRATION SYSTEM, THE LONGITUDINAL DATABASES AND THE PUBLIC HEALTHCARE SYSTEM, THEN YOU CAN REALLY HAVE A COHORT OF CLOSE TO 10 MILLION PEOPLE. SO WHAT IS THIS CIVIL REGISTRATION SYSTEM? IT WAS AS I SAID ESTABLISHED IN APRIL '68. HERE ARE SOME OF THE MAIN DATA. THE CIVIL REGISTRATION NUMBER, CIVIL STATUS, CIVIL REGISTRATION NUMBER OF FATHER, MOTHER, CHILDREN, DEATH DATA, IMMIGRATION DATA AND EMIGRATION DATA. AND THIS CIVIL REGISTRATION NUMBER IS USED IN ALL REGISTRIES IN DENMARK, AND THAT'S WHY YOU CAN ACTUALLY LINK THESE REJ REGISTRIES TOGETHER. AND HERE'S THE TAX BILL. AND YOU CAN ACTUALLY FILL IN OVER THE INTERNET NOW. BUT THIS IS REALLY THE REASON FOR THESE HIGH QUALITY DAYE TA DATABASES IN DENMARK THAT THEY CAN BE LINKED TOGETHER. SO ALL OVER THE WORLD, YOU HAVE A LOT OF DATA. HERE IS AN EXAMPLE, DATA SCREENING, MAYBE SOME PRIMARY DATA COLLECTION DATA AND PHARMACY DATA. BASED ON THIS CIVIL REGISTRATION NUMBER, WE CAN ACTUALLY LINK ALL THE THE DATA INTO ONE COHORT. AND THE CIVIL REGISTRATION NUMBER -- THE FIRST -- ACTUALLY THE BIRTHDAY OF THE PERSON. SO BASED ON THIS CIVIL REGISTRATION NUMBER, WE ARE ABLE TO GET A COMPLETE PICTURE OF THE MEDICAL HISTORY. SO THE DANISH HEALTHCARE SYSTEM, ACTUALLY THE POPULATION IS NOW 5.5 MILLION, BUT AS I SAID, THE COHORT SINCE '68, IT COVERS BETWEEN 9 AND 10 MILLION PEOPLE. WE HAVE FREE TAX SUPPORTED HEALTHCARE, VISITS AT GENERAL PRACTITIONER, VISITS AT SPECIALIST,, ADMISSIONS TO HOSPITAL AND A PART OF THE COST TO DRUGS IS PAID. WE HAVE THE HEALTH INSURANCE CARD BUT IT IS A CREDIT CARD. WHEN WE D GO TO A DOCTOR, WE USE THIS CARD AND IMMEDIATELY THE INFORMATION IS TRANSFERRED TO A COMPUTER. WE ALSO USE IT IN PHARMACIES AND GENERAL PRACTITIONER. SO I WANT TO GIVE A BRIEF OVERVIEW OF SOME OF THE REGISTRIES THAT MIGHT HAVE INTEREST TO YOU AND GIVE SOME EXAMPLE OF PAPERS BASED ON THESE REGISTRIES. ONE OF THE MOST WELL-KNOWN REGISTRIES AND ONE OF THE BEST IS THE NATIONAL REGISTRY OF PATIENTS THAT WAS ESTABLISHED IN '77 AND THE POPULATION COVERS ALL PATIENTS OR ALL PERSONS HOSPITALIZED IN DENMARK INPATIENTS SINCE 77, OUTPATIENTS SINCE '94, EMERGENCY ROOM SINCE '94, AND THERE ARE -- SOME OF THE MAIN VARIABLES ARE OF COURSE THE CIVIL REGISTRATION NUMBER, THE -- DEPARTMENT ADMISSION AND DISCHARGE DATA, SOME TEST DATA AND SOME TREATMENT WE USE -- FROM '77 TO '93 AND ICD 10 SINCE '94. WE HAVE NEVER USED ICD 9 IN DENMARK. AND IF YOU GO TO THIS SKS BROWSER AT THE INTERNET, THEN YOU ARE ABLE TO SEE THE DATA COLLECTED IN THIS REGISTRY. I THINK THIS IS ACTUA ACTUALLY A DANISH VERSION, NOW IT IS IN AN ENGLISH VERSION. WE PUBLISHED THIS REGISTRY LAST YEAR, IT WAS THE LONGITUDINAL START OF THE INCIDENT OF ACUTE MMYOCARDIAL INFARCTION, AND WE LOOKED AT THE LONG AND SHORT TERM MORTALITY, AND THE REASON FOR THIS WAS THAT THERE'S BEEN A DEBATE IF THE RATE OF THE CURE OF MYOCARDIAL INFARCTION WAS DECREASING IN WESTERN EUROPE, AND HERE'S THE MAIN RESULT OF THE STUDY. HERE YOU HAVE THE INCIDENT RATE, HERE YOU HAVE -- ACTUALLY YOU CAN SEE HERE THAT FOR MEN, THE -- DECREASED DOWN TO THE YEAR 2000. THE DECREASE WAS NOT SO PRONOUNCED FOR WOMEN. THEN YOU SEE AN INCREASE AGAIN. THIS IS VERY INTERESTING, FROM AN -- ACTUALLY HERE YOU -- FOR THE DIAGNOSIS OF ACUTE MYOCARDIAL INFARCTION. THEN YOU SAY THIS INCREASE, AND THE INCREASE HAS CONTINUED. AND WE EXPECT THAT WE'LL SEE THESE 20 YEARS FROM NOW IF YOU MAKE A PREDICTION. BUT WHAT IS IMPORTANT HERE, THAT OF COURSE MANY PEOPLE HAVE WONDERED WHAT IS THE EXPLANATION FOR THE LAST 25 YEARS. IT SEEMS THAT THE MAJOR EXPLANATION IS ACTUALLY THE DECREASE OF SMOKING RATES IN DENMARK, BECAUSE -- AM MEN BUT NOT A AMONG WOMEN. AT THE SAME TIME, A PAPER WAS PUBLISHED ABOUT MORTALITY IN THE UNITED STATES, IN THE NEW ENGLAND JOURNAL OF MEDICINE, AND YOU SAW EXACTLY THE SAME CURVE, AND YOU CAN SEE THE INCREASE IN INCIDENCE IS COMPLETELY INDEPENDENT OF ANY MEDICAL TREATMENT. HERE YOU HAD -- IN DENMARK. AROUND HERE -- AROUND HERE AS THE DECREASE IS COMPLETELY INDEPENDENT OF THESE NEW TREATMENTS. HERE IS ANOTHER EXAMPLE FROM THE NATIONAL REGISTRY OF PATIENTS. IT WAS A STUDY ABOUT THE RISK OF SUBARACHNOID BLEEDING IN FIRST DEGREE RELATIVES TO PATIENTS WITH SUBARACHNOID BLEEDING AND IT WAS STARTED BASED ON THE CIVIL REGISTRATION SYSTEM WHERE WE CREATED ALL FAMILIES IN DENMARK. AND LOOKED AT THE INCIDENCE OF SUBARACHNOID BLEEDING AND WE FOUND THAT THERE WAS A -- OF TWO FAMILIES IN SUBARACHNOID BLEEDING. NEW STUDIES HAVE ACTUALLY SHOWN THAT IT IS PROBABLY NOT A GENETIC FACTOR, IT IS SHARED RISK FACTORS IN FAMILIES, WHICH IS RESPONSIBLE FOR THIS INCREASED RISK IN FAMILIES. HERE IS ANOTHER EXAMPLE OF JUST PUBLISHED A COUPLE OF MONTHS AGO IN THE LANCET, AND IT IS ACTUALLY A RANDOMIZED TRIAL, A STENT TRIAL, AND I HAVE TAKEN THIS PAPER WITH ME JUST BECAUSE IT SHOWS A NEW CONCEPT FOR CLINICAL TRIALS. BECAUSE IT'S A KIND OF -- THEY RANDOM MIEZ THE PATIENTS IMMEDIATELY WHEN THEY ARRIVE TO THE HOSPITAL AND THEN THEY DO -- THEIR INVESTIGATORS DO NOT SEE THE PATIENTS ANYMORE, THEY COLLECT ALL THE FOLLOW-UP DATA FROM THE NATIONAL REGISTRY OF PATIENTS. SO IT'S A VERY INEXPENSIVE WAY TO CONDUCT LARGE CLINICAL TRIALS, BECAUSE YOU CAN GET ALL THE COMPLETE FOLLOW-UP INFORMATION FROM THE REGISTRIES. THIS IS ACTUALLY WELL-KNOWN HERE AROUND WASHINGTON BECAUSE THE NATIONAL CANCER INSTITUTE HAS WORKED WITH THIS REGISTRY FOR DECADES, BUT IT WAS ESTABLISHED DURING THE SECOND WORLD WAR IN '43. IT HAS INFORMATION ON ALL CANCER PATIENTS IN DENMARK AND THERE ARE SOME BASIC -- IN THE REGISTRY. IT'S NOT DETAILED BUT IT'S VERY COMPLETE. HERE'S A START -- ALMOST 50 YEARS AGO IN THE NEW ENGLAND JOURNAL OF MEDICINE BECAUSE THERE HAD BEEN A DISCUSSION FOR MANY YEARS WHETHER OR NOT -- WAS A -- OR CANCER. SO WE IDENTIFIED A LARGE COHORT OF PATIENTS WITH -- EMBOLISM FROM THE NATIONAL REGISTRY OF PATIENTS AND THEN WE LINKED THE DATA INTO THE CANCER REGISTRY AND DETERMINED THE INCIDENCE AMONG PATIENTS AND WE FOUND A RELATIVE RISK OF -- FOR CANCER DIAGNOSIS THE YEAR OF A DIAGNOSIS -- [INAUDIBLE] A RELATIVELY NEW BUT VERY EXCITING REGISTRY IS THE DANISH NATIONAL PATHOLOGY REGISTRY. IT WAS ESTABLISHED IN '97, SO IT HAS DATA FOR THE LAST 16 YEARS, BUT ACTUALLY IN THE VARIOUS REGIONS IN DENMARK, YOU ARE ABLE TO GO BACK TO THE 70s, BECAUSE THEY HAVE A REGIONAL INFORMATION SYSTEM. THIS REGISTRY HAS INFORMATION ABOUT ALL BIOLOGICAL SPECIMENS FROM THE DANISH HOSPITALS, AND THIS REGISTRY USED THE -- CODES. I'LL COME BACK TO THAT REGISTRY A LITTLE BIT LATER, WHEN I TALK ABOUT -- IN DENMARK. BUT HERE A SIMPLE STUDY PUBLISHED A COUPLE YEARS AGO -- ADENOCARCINOMA WHA. WE DI. WE CREATE ADD COHORT BASED ON BIOPSIES FROM THE PATHOLOGY REGISTRY AND WE LINKED THAT INFORMATION INTO THE CANCER REGISTRY AND DETERMINED THE INCIDENCE OF ADENOCARCINOMA. SO BASICALLY THE STUDY WAS -- THE STUDY IDEA WAS NOT NEW BUT WHAT WE FOUND THAT STUDY WAS A MUCH LOWER INCIDENCE OF CANCER THAN REPORTED IN OTHER STUDIES IN THE LITERATURE. THE FIRST REGISTRY WAS ESTABLISHED IN '73, AND IT HAS INFORMATION ABOUT ALL BIRTH IN DENMARK SINCE '73 AND THERE ARE AROUND 60 TO 70,000 BIRTHS IN DENMARK EACH YEAR. THE MAIN DATA ARE THE CIVIL REGISTRATION NUMBER, BIRTH WEIGHT, BIRTH LENGTH, BIRTH PRESENTATION, APGAR, SURGERIES, BIRTH ORDER AND BIRTH DEFECTS. HERE'S AN EXAMPLE STARTING SOME YEARS AGO, IN THE MEDICAL JOURNAL WHERE WE LINKED THE PRESCRIPTION DATABASE INTO THE FIRST REGISTRY, AND WHAT WE DID WAS WE LOOKED AT THE WORST OUT COME, RISK OF MISCARRIAGE IN PREGNANT WOMEN WHO TOOK -- DURING PREGNANCY AND WE FOUND THERE WAS ACTUALLY NO ASSOCIATION WITH ADVERSE BIRTH OUTCOMES, WHEN WE LOOKED AT ABORTION, THEN WE FOUND A STRONGLY INCREASED RISK IF THE WOMEN -- THIS FINDING HAS BEEN REPLICATED IN SEVERAL OTHER STUDIES. THE PSYCHIATRIC REGISTRY GOES BACK ACTUALLY TO '58 BUT IT HAS BEEN COMPUTERIZED SINCE '69. IT HAS INFORMATION ABOUT ALL PSYCHIATRIC HOSPITAL ADMISSIONS IN DENMARK AND ALSO SINCE '95, OUTPATIENT CONTACTS. AND IT HAS THE SAME INFORMATION AS THE NATIONAL REGISTRY OF THE PATIENT. AND I THINK IT'S ONE OF THE ONLY PSYCHIATRIC REGISTRIES IN THE WORLD. AND HERE IS AN EXAMPLE OF A PAPER PUBLISHED BY A GROUP FROM DENMARK, I THINK IT WAS LAST YEAR OR A COUPLE YEARS AGO IN THE NEW ENGLAND JOURNAL OF MEDICINE, WHERE THEY LOOKED -- INDUCE ABORTION IN THE FIRST TRIMESTER -- MARKER FOR LATER MENTAL DISORDERS, AND AS FAR AS I REMEMBER, THEY DID NOT FIND ANY -- IN THAT STUDY. THE NATIONWIDE PRESCRIPTION REGISTRY IS A VERY INTERESTING REGISTRY. IT WAS ESTABLISHED ALMOST 20 YEARS AGO IN '94, BUT BECAUSE OF THERE WAS A DISCUSSION ABOUT REGISTRY RESEARCH AT THAT TIME, AND THE GOVERNMENT HAD THE IMPRESSION THAT THIS REGISTRY WOULD BE TOO DANGEROUS TO MAKE AVAILABLE FOR RESEARCH. SO THEREFORE, THEY DECIDED TO PUT A COPY OF THIS REGISTRY INTO A GOVERNMENT DATABASE CALLED STATISTIC DENMARK. THEY COLLECTED DATA, AND ACCORDING TO DANISH LAW, THEY SHOULD NOT RECORD THE CIVIL REGISTRATION NUMBER BUT THEY DID RECORD IT, SO IT HAS NOT BEEN DELETED, AND YET 2002, THE GOVERNMENT DECIDED THAT REGISTRY RESEARCH SHOULD BE MAIN RESEARCH, AND IN DENMARK, IT WAS DECIDED THIS SHOULD BE TRANSFERRED TO ANOTHER -- SO YOU COULD ACTUALLY WORK WITH THE PRESCRIPTION DATA OVER MODEM. BUT THE DATA COULD NOT LEAVE STATISTIC DENMARK. AND IT'S STILL AN ISSUE THAT YOU COULD ONLY WORK WITH THIS DATA BAIT BASTE IF YOU COULDATABASE IF YOU COUL D WORK BY MODEM. HERE'S AN EXAMPLE, A GROUP IN BOSTON WHERE WE IDENTIFIED PEOPLE WITH BREAST CANCER RECUR, AND THE DANISH BREAST CANCER DATABASE, THEN WE LINK THE DATA INTO THE PRESCRIPTION RATE AND IF THERE WAS AN ASSOCIATION BETWEEN USE OF -- AND REDUCED RISK OF BREAST CANCER -- WE FOUND 20% REDUCED RISK IF THE BREAST CANCER PATIENT TOOK -- AFTER THE DIAGNOSIS. BUT THIS PRESCRIPTION REGISTRY HAS REALLY BEEN A TOPIC FOR DEBATE IN DENMARK, BECAUSE WE CANNOT PARTICIPATE IN INTERNATIONAL STUDIES BECAUSE WE CANNOT TAKE THE DATA OUT OF STATISTIC DENMARK, AND WE HAVE SEVERAL ONGOING PRESCRIPTIONS. SO TO GET A -- HE AND I DECIDED WE SHOULD TRY TO NEGOTIATE NOT WITH THE NATIONAL GOVERNMENT BUT WITH THE REGIONAL GOVERNMENT. WAN COUPLE YEARS, I ACTUALLY FOUND OUT THEY HAD NOT DELETED THEIR PRESCRIPTION DATA. SO WE MADE A CONTRACT AND A 1 1/2 YEAR GOAL, THE DATA WERE TRANSFERRED TO OUR DEPARTMENT, SO WE HAVE A NATIONWIDE PRESCRIPTION REGISTRY IN OUR DEPARTMENT WITH DATA SINCE 2004, AND IT HAS ACTUALLY THE SAME INFORMATION AS THE NATIONAL PRESCRIPTION REGISTRY AND WE ARE ABLE TO USE THIS REGISTRY FOR INTERNATIONAL COLLABORATION SINCE WE'RE ABLE TO TRANSFER THE DATA OUT OF DENMARK. AND HERE IS AN EXAMPLE, A STUDY WAS PUBLISHED A COUPLE MONTHS AGO IN THE JOURNAL OF GERMAN MED SANE SIN THAT LOOKED AT THE USE OF STEROIDS AND THE RISK OF EMBOLISM. AS YOU CAN SEE, WE FOUND AN INCREASED RISK OF 2.3. SO IT IS POSSIBLE TO GET ACCESS TO THESE PRESCRIPTION DATA AND TO USE THEM FOR INTERNATIONAL COLLABORATION, AND WE ARE ALSO ALLOWED TO CONTACT PHYSICIANS AND PATIENTS. WE GOT PERMISSION FROM THE DANISH DATA PROTECTION BOARD. HERE IS THE NEW GROUP OF RELATIVELY NEW DATABASES. THEY ARE CALLED THE CLINICAL QUALITY DATABASES. I'M SURE YOU HAVE A SIMILAR CONCEPT IN UNITED STATES. THESE DATABASES, A COUPLE OF THEM ARE RELATIVELY OLD, 30 YEARS OLD, BUT MANY OF THEM, THEY ARE ESTABLISHED DURING THE LAST 10 TO 15 YEARS. AND THERE ARE 60-SUCH DATABASES IN DENMARK, AND THEY ARE REALLY WHAT I WILL CALL CLINICAL COHORTS. HERE EXAMPLES OF THE EAST THESE CLINICAL COHORTS. THE STROKE DATABASE WAS ESTABLISHED IN 2003, AND PARTICIPATION IS MANDATORY FOR ALL HOSPITAL DEPARTMENTS IN DENMARK, AND THE GOAL OF THIS REGISTRY IS ACTUALLY TO MONITOR QUALITY OF HOSPITAL CARE, AND IF THERE'S A LOT OF INFORMATION ABOUT TREATMENT AND DIAGNOSTIC PROCEDURES. THE DATABASE HAS NOW MORE THAN 100,000 PATIENTS WITH STROKE BY JANUARY 2013. AND I THINK LESS THAN FIVE PAPERS HAVE ACTUALLY BEEN PUBLISHED BASED ON THIS REGISTRY. IF YOU WANT TO KNOW MORE ABOUT THIS STROKE DATABASE, I THINK IT'S ONE OF THE BEST DATABASES IN THE WORLD, THEN YOU CAN TAKE A LOOK AT THIS PAPER FROM MEDICAL CARE, 2008, WHERE WE LOOKED AT THE QUALITY OF CARE AND SHORT TERM MORTALITY, BUT THERE ARE 60 LARGE COHORTS WITH VERY CLINICAL DATA AND ACTUALLY THEY ARE NOT MAINLY USED FOR RESEARCH AND I HOPE THIS SITUATION WILL CHANGE OVER THE NEXT DECADE. A LITTLE BIT ABOUT THE STRUCTURE OF GENERAL PRACTICE IN DENMARK. IN DENMARK, WE CALL THE GENERAL PRACTITIONER, I THINK YOU CALL THEM FAMILY PHYSICIANS IN THE UNITED STATES, AND THEY ARE ACTUALLY GATE KEEPERS TO THE SECONDARY HEALTHCARE -- 99% OF ALL DANES ARE REGISTERED WITH THEIR OWN G.P. AND THEN THEY RECEIVE FREE MEDICAL CARE IF THEY GO TO THIS GENERAL PRACTITIONER. 1% OF THE POPULATION, THEY CAN SELECT THEIR OWN GENERAL PRACTITIONER, BUT THEN THEY HAVE TO PAY PART OF THE FEE. THE GENERAL PRACTITIONERS IN DENMARK, THEY HAVE 45 MILLION PATIENT CONTACTS EACH YEAR, AND THEY FINISH 90% OF THE PATIENTS IN THEIR OWN PRACTICE. ONLY 10% OF THE PATIENTS IN DENMARK ARE REFERRED TO SECONDARY HEALTH. IN 2007, A KIND OF ASSOCIATION BETWEEN A PRIVATE COMPANY AND THE DANISH ASSOCIATION OF GENERAL PRACTITIONERS, THEY DECIDED THAT THEY WOULD ESTABLISH A DANISH QUALITY UNIT OF GENERAL PRACTICE WITH THE AIM OF MONITORING THE QUALITY OF THE CARE IN GENERAL PRACTICE IN DENMARK. AND WHAT THEY DO IS THAT THEY COLLECT DATA FROM ALL GENERAL PRACTICES IN DENMARK, THROUGH VARIOUS DATA SOURCES, AND THEN THEY PROVIDE THE FEEDBACK TO THE GENERAL PRACTITIONERS ABOUT THE QUALITY OF THE WORK. THEY HAVE TO -- ACTUALLY THIS DATABASE WAS ESTABLISHED WITHOUT ANY INVOLVEMENT OF ANY RESEARCHERS. SO IT HAS A STRUCTURE THAT MAKES IT IMPOSSIBLE TO DO RESEARCH UNFORTUNATELY, SO BUT THE GOAL IS WE'LL TRY TO REORGANIZE THIS DATABASE AND MAKE IT AVAILABLE FOR RESEARCH IN THE FUTURE, THEN YOU WILL ACTUALLY HAVE DATA FOR -- ALL FAMILY PHYSICIANS, SPECIASPECIALISTS AND HOSPITALIZATIONS IN DENMARK. I'LL GIVE YOU SOME EXAMPLE OF THE DANISH BIOBANK, AND I'LL MENTION TWO BIOBANKS TODAY. AS I SAID BEFORE WHEN I READ YOU THIS DANISH REGISTRY PATHOLOGY, ALL TISSUE OR TISSUE OF ALL SPECIMENS FROM DANISH HOSPITAL HAS BEEN STORED FOR THE LAST 40 OR 50 YEARS, SO YOU CAN ACTUALLY GO BACK AND FIND TUMOR TISSUE FROM '65 OR '75 IF YOU HAD THE NAME OF THE PATIENT. ALSO FOR THE ENTIRE DANISH PUBLICATION, DENMARK DNA IS -- BORN AFTER 91 IN THE PKU BANK IN COPENHAGEN. SO THERE ARE TWO MAJOR BIOBANKS THAT CAN BE USED FOR GENETIC EPIDEMIOLOGY, AND I WILL SHOW YOU AN EXAMPLE HERE, STARTING WITWITH SOME AMERICAN AND CANADIAN INVESTIGATORS, AND THAT'S BEEN A DEBATE FOR DECADES -- POLYPS IN THE LARGE BOWEL, IF THEY ARE RISK FACTORS FOR CANCER. NOBODY HAS BEEN ABLE TO STUDY THAT IN DETAIL. SO WE DECIDED A COUPLE OF YEARS AGO TO DO SUCH A STUDY. WHAT WE DID WAS FIRST WE CONSULTED THE PATHOLOGY REGISTRY AND THIS PILOT IS A RELATIVELY NEW PILOT, SO THE SNOW MED CODE WAS INTRODUCED IN DENMARK SINCE 5, AND THE IMPRESSION IS THAT IT TAKES AT LEAST 20 YEARS FOR THESE POLYPS TO DEVELOP A CANCER. SO IT WAS STARTED -- THE AIM WAS TO STUDY THE NATURAL HISTORY OF PATIENTS WITH SER RATED POLYPS. WE KNEW FROM THE CLINICIANS, THEY DO NOT DO ANYTHING WITH THESE POLYPS. SO WHAT WE DID WAS WE IDENTIFIED ALL PATIENTS WITH A COLONOSCOPY IN DENMARK SINCE '77, A CLEAN COLONOSCOPY, AND IT MEANS THAT THEY MUST NOT HAVE A CORRECTED CANCER DIAGNOSIS IN THE FIRST SIX MONTHS AFTER COLONOSCOPY. BASED ON THIS, WE WERE ABLE TO IDENTIFY 2,000 CASES FOF COLORECTAL CANCER, AROUND 8,000 POPULATION CONTROLS BASED ON WHAT WE CALL -- SAMPLING. THEN WE WENT BACK TO ARCHIVES ALL OVER THE COUNTRY AND WERE ABLE TO IDENTIFY 927 CASES, CONTROLLED WITH A POLYP, AND WE WERE ABLE TO IDENTIFY IN '97 THE -- OF ALL THE PO LIPS. THEN THE POLYPS WERE RECLASSIFIED ACCORDING TO A NEW CRITERIA, SO HERE IS THE STUDY SE DINE. IT'S ACTUALLY A LITTLE BIT COMPLICATED. WE IDENTIFIED THE PATIENTS AS YOU CAN SEE BASED ON THE NATIONAL REGISTRY OF PATIENTS WHERE ALL COLONOSCOPIES WERE RECORDED AND THEN WE LINK THE DATA TO THE PATHOLOGY REGISTRY THROUGH THE PATHOLOGY DEPARTMENTS ALL OVER THE COUNTRY AND TO THE CANCER REGISTRY THROUGH THE CIVIL REGISTRATION NUMBER AND THEN WE ESTABLISHED THIS RESEARCH DATABASE. ANOTHER WAY TO DESCRIBE THE STUDY DESIGN. SO HERE'S THE RESULT OF THE STUDY. HERE ARE THE 2,000 CASES AND THE CONTROLS. HERE YOU CAN SEE THE FINDINGS. HERE IN THE COLUMNS. AND ACTUALLY A LARGER PORTION OF THE PATIENTS DID NOT HAVE POLYPS, BUT AS YOU CAN SEE, THEY SUSPECT THE PROPORTION WHERE NO POLYPS -- WHERE IT'S NOT VERY HIGH IN THE COLORECTAL CANCER GROUP. SO WHAT WE DID IS THAT WE CREATED A NEW INFORMATION SYSTEM AND HERE WE HAVE THE RESULT OF THE -- AND HERE WE HAVE THE SAMPLE. WE HAVE THESE FIVE PATHOLOGIES, TWO IN UNITED STATES, ONE IN CANADA AND TWO IN EUROPE, AND THEY REVIEWED ACTUALLY ALL THE SPECIMENS OVER THE INTERNET, AND THEN THEY GAVE THEM A FINAL DIAGNOSIS AND THEN THE DATA WERE RECORDED IN OUR DATABASE. HERE ARE SOME PRELIMINARY RESULTS BECAUSE THE STUDY HAS JUST BEEN FINISHED. HERE WE HAVE THE ORs RATIO. IF YOU HAVE A SE RATED POLYP, THE RISK OF IS HIGH, BETWEEN TWO AND FOUR. SO IN THIS BODY DESIGN, WE HAVE BEEN ABLE TO PROVE THAT POLYPS ARE STRONG RESPECTERS OF COLORECTAL CANCER. THE RISK FOR OTHER POLL IX IS -- I THINK THIS IS A VERY EXCITING BIOBANK TO USE THESE ARCHIVES IN DANISH HOSPITALLING. A LITTLE BIT ABOUT -- THERE'S FREE ACCESS TO THE DATA, BUT OF COURSE IF YOU WANT TO WORK WITH THE DATA, IT MIGHT BE STRANGE TO WORK WITH SOME DANES BECAUSE A LOT OF THE TEXT IS ACTUALLY IN DANISH. IT'S RELATIVELY INEXPENSIVE TO GET THE DATA WHEN YOU HAVE GOT THE PERMISSION, AND IT'S ALSO RELATIVELY EASY TO GET THE PERMISSION BY THE DANISH DATA PROTECTIONS AGENCY. IF YOU ONLY USE REN REGISTRY DATA -- YOU ONLY NEED A PERMISSION FROM THE DANISH DATA PROTECTION AGENCY AND YOU CAN ACTUALLY SEND THE MCATION OVER THE INTERNET -- THE APPLICATION TO THE ADDRESS YOU HAVE HERE. HERE IS AN EXAMPLE OF SUCH AN APPLICATION MAIN DECISION, BRIEF DESCRIPTION OF THE STUDY, AND THEN A COUPLE WEEKS LATER, YOU WILL GET THE PERMISSION AND YOU'RE ABLE TO DO THE STUDY. SO IT'S RELATIVELY EASY. SO WHY DO PEOPLE ACCEPT -- WITHOUT THE SAME DISCUSSION YOU HAVE IN OTHER EUROPEAN COUNTRIES AND YOU ALSO HAVE THIS DISCUSSION IN THE UNITED STATES? I THINK ONE OF THE REASONS IS THAT THE DANISH SOCIETY HAS ONE OF THE HIGHEST LEVEL OF TRUST IN THE WORLD, AND I'LL COME BACK TO THAT A LITTLE LATER BECAUSE IT HAS BEEN SHOWN IN SEVERAL SURVEYS. WE HAVE A RELATIVELY WELL EDUCATED SOCIETY, AND THEY ALL SUPPORT RESEARCH. WE HAVE A PUBLIC HEALTHCARE SYSTEM, AND THEY EXPECT TO DELIVER THEIR EPR NUMBER AND THEY ACCEPT THE DATA ARE COLLECTED FOR RESEARCH PURPOSES. SO THIS CIVIL REGISTRATION NUMBER IS USED IN YOUR BANK, IT IS USED IN YOUR COMPANY, SO ALL THE DANES, THEY ACCEPT THAT YOU CAN USE THE CIVIL REGISTRATION NUMBER TO LINK THE DATA. -- THE REGISTRY BASED RESEARCH SHOULD HAVE HIGH PRIORITY, AND I MUST ALSO STRESS THERE ARE NO EXAMPLES OF MISUSE OF DATA FOR SCIENTIFIC PURPOSES IN DENMARK. BUT ACTUALLY LAST WEEK THE -- STORY IN DENMARK BECAUSE A PERSON FROM SWEDEN, HE WAS ABLE TO EXTRACT 4 MILLION -- PR NUMBERS FROM DENMARK BUT THERE HAS BEEN NO EXAMPLES OF MISUSE OF DATA IN THE SCIENTIFIC COMMUNITY IN DENMARK. HERE IS SOMETHING I FOUND AT THE INTERNET A COUPLE DAYS AGO, JUST TO SHOW THAT I THINK TRUST IS AN IMPORTANT FACTOR FOR REGISTRY-BASED RESEARCH IN DENMARK. THERE'S BEEN AS I SAID SEVERAL SURVEYS SHOWING THAT. BUT NOW SOME SENSITIVE DATA. THE PRESCRIPTION DATA IN THE NATIONAL PRESCRIPTION REGISTRY IS AN EXAMPLE OF SUCH DATA. BUT THERE ARE OTHER DATA, WE HAVE DATA ABOUT EDUCATION AND HOW MUCH YOU PAY IN TAX AND WE ALSO HAVE DATA ABOUT SCHOOL PERFORMERS. AND THESE DATA, THEY ARE NOT ALLOWED TO BE DELIVERED OUTSIDE -- BUT YOU CAN USE THE DATA. IT TAKES SOME TIME AN IT'S A LITTLE BIT DIFFICULT, BUT YOU COULD GET AK A SES TO THE DATA. HERE IS A TABLE WE PUBLISHED LAST MONTH IN JAMA WHERE WE LOOKED AT MENINGITIS AS A RISK FACTOR FOR LATER EDUCATION, AND WE FOUND A STRONG ASSOCIATION BETWEEN MENINGAL COCCAL DISEASE AND 20 YEARS LATER. WE ALSO LOOKED AT THE EDUCATIONAL LEVEL AMONG SIBLINGS TO PATIENTS WITH THE DISEASE AND WE FOUND EXACTLY THE SAME PATTERN, INDEPENDENT OF THE DISEASE. AND WE HAVE CONTROL FOR MANY SOCIOECONOMIC FACTORS BUT IT SEEMS THERE'S AN UNDERLYING FACT NOT RELATED TO MENINGITIS RESPONSIBLE FOR THIS ASSOCIATION. SO REGISTRY BASED RESEARCH IN DENMARK COMPARED TO MANY OTHER COUNTRIES IS RELATIVELY EASY TO DO. HERE IS THE SITUATION. I THINK IT COULD BE GERMANY. WHERE IT'S ALMOST IMPOSSIBLE TO DO REGISTRY-BASED RESEARCH. BUT STILL WE HAVE A LOT OF CHALLENGES. FIRST OF ALL, THERE ARE MANY REGISTRIES AND NOBODY REALLY HAS THE OVERVIEW OF ALL THE REGISTRIES. I THINK THERE ARE MORE THAN 2,005 HYUNDAI TA BASES. SOME KIND OF MEDICAL INFORMATION IN DENMARK. AND WE DO NOT HAVE -- ANOTHER PROBLEM IS THAT MANY OFFICES ARE RESPONSIBLE FOR THE DATABASES IN THE GOVERNMENT, AND I MUST SAY THAT RESEARCH IS NOT THE MAIN GOAL OF THESE OFFICES. WHEN YOU HAVE THE PERMISSION, SOMETIMES IT CAN TAKE A LOT OF TIME BEFORE THEY DELIVER THE DATA TO YOU ALTHOUGH THEY SHOULD DELIVER THE DATA ACCORDING TO -- LAW. BUT -- HUGE POTENTIAL FOR RESEARCH BASED ON THESE REGISTRIES, SO TO SOLVE SOME OF THESE PROBLEMS, I HAVE BEEN LEADING AB INITIATIVE BY TWO LARGE FOUNDATIONS FOR THE LAST SIX MONTHS, AND AS YOU MIGHT RECALL, THERE ARE THREE GROUPS OF DATABASES, THE NATIONAL HEALTH REGISTRY, THE CLINICAL DATABASES AND THE GENERAL PRACTITIONER DATABASE. AND WE HAVE CREATED A PROPOSAL WITH THE AIM OF CREATING A LARGE PLATFORM SO YOU HAVE AN OVERVIEW OF ALL THE DATABASES AND ALL THE DATABASES SHOULD BE IN ONE PLATFORM AND YOU CAN -- THE DATA TO THE BIOBANK DATA, AND THEN YOU COULD GET DATASET AND BIOBANK DATASET -- RESEARCH, AND HOPEFULLY SOME OF THE ARGUMENTS OF THIS INITIATIVE SHOULD BE BETTER DIAGNOSTIC AND TREATMENT IMPROVED CLINICAL QUALITY, IMPROVED PATIENT SAFETY AND LOWER COST, BUT WE HAVE BEEN WORKING SINCE MID AUGUST LAST YEAR WITH THIS PROPOSAL, AND THE PROPOSAL WAS FINISHED BY THE END OF NOVEMBER, BUT THERE'S A LOT OF POLITICAL DISCUSSION ABOUT THE PROPOSAL. BECAUSE THE VARIOUS OFFICES DO NOT ACCEPT THEY SHOULD DELIVER DATA INTO ONE PLATFORM, BUT HOPEFULLY LATER THIS YEAR, WE'LL BE ABLE TO -- THE PROPOSAL FOR INTERNATIONAL -- IF YOU WANT TO KNOW SOMETHING ABOUT MEDICAL DATABASES, THIS LITTLE BOOK CALL, YOU CAN ACTUALLY GET A PDF FILE OF THE BOOK FROM OUR WEBSITE. HERE IS OUR WEBSITE. HERE YOU HAVE THE LINK TO THIS PDF FILE AND THEN YOU CAN GET A GOOD OVERVIEW OVER THE MAIN REGISTRIES AND THE MAIN BARRIERS, AND HERE IS AN EXAMPLE OF A DESCRIPTION OF THE DANISH MEDICAL BIRTH REGISTRY, YOU HAVE AIM OF THE REGISTRY, THE POPULATION, THE TIME PERIOD, AND THE DESCRIPTION OF THE DATA, AND ALSO IF THERE ARE PROBLEMS WITH -- DATA, IT IS ALSO DESCRIBED IN THIS LITTLE BOOK. SO YOU CAN HAVE A LOT OF FUN WITH REGISTRIES AND REGISTRATIONS, BUT FOR ME, I WOULD SAY IT'S THE GOAL OF MY PROFESSIONAL LIFE TO IMPROVE REGISTRY BASED RESEARCH. THANK YOU. [APPLAUSE] >> THANK YOU, HENRY. WE HAVE TIME FOR QUESTIONS. I HAVE ONE. OH, GO AHEAD. >> WONDERFUL TALK. I JUST HAVE ONE QUESTION. SO HOW DO YOU -- IN YOUR DATABASE, HOW DO YOU DEAL -- IF YOU'RE DOING A LONGITUDINAL STUDY OVER MANY YEARS, HOW DO YOU DEAL WITH THE SITUATION WHEN THE UNDERLYING CODING SYSTEM HAS BEEN UPGRADED, LIKE IF YOU CHANGE FROM ICB8 TO ICB10, HOW DOES THAT AFFECT YOUR DATA AND DO YOU DO REMAPPING OF YOUR DATA? >> THERE ARE SOME -- CHANGES FROM ICB8 TO ICB10. FOR EXAMPLE, STRENGTH INCREASE IN INCIDENCE OF MANY DISEASES, BUT YOU KNOW, MEDICAL RESEARCHERS DO NOT PAY ATTENTION TO SUCH MINOR -- BUT IT IS A -- >> SO THE -- HAVE TO DEAL WITH THAT CHANGE IN -- DATABASE? >> NO. >> OKAY. >> NEXT QUESTION. >> I'M JUST CURIOUS, GIVEN YOUR EXPERIENCES, AND I'M FOR GETTING THE INITIALS, IT WAS THE DATABASE THAT WAS DEVELOPED FOR QUALITY PURPOSES FROM -- OF GENERAL PRACTITIONERS' OFFICE, THERE WAS A CHALLENGE TO USE IT FOR RESEARCH PURPOSES AND GIVEN THAT YOU'RE ALSO TRYING TO FORM THE CENTRALIZED REGISTRY DATABASE, DO YOU HAVE ANY SORT OF DESIGN PRINCIPLES FOR DEVELOPING DATA MODELS FOR RESEARCH NOW THAT -- >> UNFORTUNATELY NOT. >> CAN YOU PUT YOUR MICROPHONE ON? >> HAVE YOU GIVEN THIS TALK TO OTHER AMERICAN AUDIENCES OR TALKED SIMILAR TO THIS? >> YES. >> OKAY. >> NOT SIMILAR BUT I HAVE COVERED SELECTED TOPICS. >> SO SECOND PART IS, DO YOU GET PEOPLE IN THE AUDIENCE WHO ARE VERY PRO PATIENT PRIVACY WHO ASK YOU QUESTIONS ABOUT PATIENT PRIVACY? >> YES. >> SO MY REAL QUESTION IS, ARE YOU EVER ABLE TO GIVE THEM AN ANSWER THAT SATISFIES THEM? >> I THINK THE BEST ANSWER IS THAT THERE'S BEEN NO -- THERE ARE NO -- OF DATA IN DENMARK. SO I WOULD SAY SO WELL DESIGNED COMPUTER SYSTEMS, SO IT'S REALLY IMPORTANT TO GET DATA OUT OF THE SYSTEM. SO -- OF COURSE YOU CAN -- IF YOU WANT TO MISS EUS THE DATA, YOU CAN DO IT. IF YOU HAVE THE CPR NUMBER OF THE PRIME MINISTER, THEN YOU CAN GET INFORMATION ABOUT HER ENTIRE MEDICAL HISTORY, AND THERE'S ACTUALLY A STORY ABOUT THAT IN DENMARK, AND YOU CAN PROBABLY LOOK AT THE WEB AND SEE THE STORY BECAUSE ONE NEWSPAPER COLLECTED INFORMATION ABOUT HER TAX BILL A COUPLE YEARS AGO. AND THE TAX SYSTEM SHOULD BE -- OR SHOULD HAVE THE SAME SECURITY, WHAT DO YOU SAY, FIREWALLS AS THESE MEDICAL DATABASES. BUT THAT WAS AN EXAMPLE THAT THEY WERE ABLE TO GET INTO THAT COMPUTER SYSTEM AND COLLECT THE DATA. AND THERE IS NOW AN INVESTIGATION ABOUT THAT. >> WHEN THEY STARTED THIS OUT, IT WASN'T AS WELCOMED. THE ONLY WAY YOU CAN GET THE DATA, YOU HAD TO GO TO THE BUILDING IN DOWNTOWN COPENHAGEN WITH A PENCIL AND PIECE OF PAPER AND YOU COULD ONLY TAKE OUT WHAT YOU COULD COPY. SO TRUST IS IMPROVING, AND YOU SHOULD MENTION THAT STUDY THAT WAS REALLY A POWERFUL SORT OF CATALYST ABOUT THE VACCINES. >> IT'S AN INTERESTING STORY. ONCE THE PAPER WAS PUBLISHED, I THINK IT WAS 10 YEARS AGO IN THE NEW ENGLAND JOURNAL OF MEDICINE BASED ON DANISH DATA WHERE THEY LOOKED AT THE ASSOCIATION BETWEEN VACCINE AND RISK OF AUTISM, AND THEY FOUND NO ASSOCIATION AT ALL. AND I THINK THIS PAPER WAS REALLY A STEP FORWARD FOR THE UNDERSTANDING OF THE VALUE OF THESE DATA SOURCES. BUT UNFORTUNATELY, LATER, THE SENIOR RESEARCHERS OF THAT PAPER, HE TOOK A LOT OF MONEY FROM CDC IN ATLANTA AND I THINK HE'S NOT ALLOWED TO ENTER UNITED STATES ANYMORE. SO -- >> BUT I THINK THERE'S HOPE, PERHAPS, WITH THE TREND. BUT >> BUT I WOULD SAY THE BEST EXAMPLES WE HAVE HAD IN DENMARK IS NOT SOPHISTICATED STUDIES. IT IS LARGE NEGATIVE STUDIES. FOR EXAMPLE, WE DID NOT FIND ANY ASSOCIATION BETWEEN ABORTION AND RISK OF BREAST CANCER. NO ASSOCIATION BETWEEN VACCINES AND RISK OF AUTISM. AND I THINK IN THE POPULATION OF DENMARK, THEY FOUND THAT SUCH STUDIES ARE VERY VALUABLE FOR THE POPULATION AND -- >> I HAVE TWO OTHER QUESTIONS. IS THAT A QUESTION? GO AHEAD. >> YEAH, SO I GUESS AUTISM SEGUES INTO WHAT I WAS WONDERING. A LOT OF THIS TYPE OF OBSERVATIONAL RESEARCH FOR MEDICAL QUESTIONS AND THERE'S A LOT OF INTEREST IN ASKING, LET'S SAY, IF PROCEDURE A IS BETTER THAN PROCEDURE B OR DRUG A IS BETTER. WE'VE ALWAYS HAD THIS PROBLEM THAT THERE'S THINGS YOU'RE NOT MEASURING. HAVE YOU THOUGHT ABOUT THAT, AND ANY INSIGHT INTO HOW TO APPROACH THAT KIND OF GENERAL CONCERN? >> NO, I THINK IT'S A REAL CONCERN, AND I THINK THERE ARE SOME VERY TERRIBLE OBSERVATIONAL STUDIES AND THEY HAVE REALLY BEEN BAD EXAMPLES NOT OF MISUSE OF DATA BUT BAD SCIENCE, AND THERE'S BEEN A DISCUSSION ABOUT THAT IN DENMARK. WHAT YOU NEED TO DO IS THAT YOU NEED TO TRY AND TRAIN SCIENTISTS TO BE GOOD RESEARCH, AND KNOW ALL THE LIMITATIONS WITH THE REGISTRIES. AND I'M NOT COVERING MANY OF THE LIMITATIONS TODAY BUT I COULD DO IT. I COULD TALK HOURS OR DAYS FOR LIMITATIONS OF REGISTRY-BASED RESEARCH. BUT THE NEW CONCEPT IN EUROPE IS ACTUALLY -- MANY RESEARCHERS, THEY BELIEVE THAT YOU CAN DO AN OBSERVATIONAL STUDY BASED ON -- AND GET EFFECTIVELY THE SAME RESULTS IN A CLINICAL TRIAL, AND THAT'S PROBABLY NOT TRUE BECAUSE IF YOU USE PROPENSITY SCORE, YOU NEED ACTUALLY TO HAVE MEASURED ALL THE POTENTIAL CONFOUNDING VARIABLES. >> A QUESTION ALSO, RIGHT NOW IT'S NOT POSSIBLE TO HAVE -- IN THE UNITED STATES, BUT AS I'M AWARE, THERE ARE ORIGINAL DATABASE -- HAVE A LOT OF DATA AND I'M SURE MANY PEOPLE -- SOCIAL SECURITY ADMINISTRATION HAS A LOT OF DATA, AND EVERYONE, DECEASED, INFORMATION BECOMES PUBLIC, SO WE UNDERSTAND IN THE U.S. THERE'S A HUGE RESISTANCE TO RELEASE OF DATA BUT A LOT OF THE DATA IS ALREADY PUBLIC. WE DON'T KNOW ABOUT IT. BUT IT'S ALREADY PUBLIC. SO MAYBE 10 YEARS DOWN THE ROAD OR 20 YEARS DOWN THE ROAD, WE MAY HAVE A STATEWIDE OR LIKE A REGION WIDE OR COMMUNITY WIDE DATABASE, SIMILAR TO WHAT YOU HAVE IN DENMARK OR SWEDEN. SO -- OTHERWISE FOR SOMEONE WHO IS GOING TO TRY TO DOT SAME THING IN THE U.S., WHETHER IT'S STATE OR REGION OR WHATEVER WHATEVER. >> I THINK YOU NEED TO TALK TO THE GOVERNMENT AND PEOPLE IN THE GOVERNMENT. WE HAD A SUBSTANTIAL NUMBER OF MEETINGS AND WE EXPLAINED THAT THEY COULD PROBABLY REDUCE THE COST IN THE HEALTHCARE SECTOR, BECAUSE YOU COULD GET BETTER EVIDENCE FOR DIAGNOSIS AND TREATMENT AND WE CAME UP WITH SOME EXAMPLES, AND WE WANTED TO SHOW THEM -- IT OPENED THEIR EYES AND AFTER SOME YEARS, THEY ACCEPTED THAT WE COULD USE THE DATA. BUT I THINK WE'LL SEE A NEW DISCUSSION WITHIN THE NEXT 10 YEARS, AND WHEN YOU SEE THE FIRST STUDIES BASED ON GENETIC MARKERS, SO YOU ARE ABLE TO IDENTIFY A SMALL PROPORTION OF THE POPULATION WITH A HIGH RISK, FOR EXAMPLE, OF CANCER OR CARDIOVASCULAR DISEASE AND YOU'RE NOT ABLE TO DO ANYTHING ABOUT IT, THEN I THINK YOU WILL GET THE DISCUSSION AGAIN. >> ALSO SIMILAR TO THE QUESTION ASKED, HAVE YOU GIVEN A SIMILAR TALK IN CANADA? >> NO. >> THE REASON I'M ASKING THAT IS IN CANADA IS SOMEWHERE IN BETWEEN. SO WHEN THEY DON'T HAVE THE SAME SYSTEM AS YOU HAVE, THEY HAVE A MUCH BETTER REGISTRY SYSTEM THAN THE U.S. THEY HAVE A VERY COMPREHENSIVE HOSPITAL -- HOSPITALIZATION DATABASE. CLOSE TO TORONTO. IT COVERS ABOUT 75% OF ALL HOSPITAL -- CASES IN THE COUNTRY. SO I WAS THINKING COULD IT BE CLOSE -- COULD IT BE RELATIVELY EASIER TO GO TO YOUR STAGE, BUT THAT HASN'T HAPPENED. I DON'T KNOW WHY. I WAS JUST CURIOUS. >> ANOTHER ARGUMENT WE GAVE TO THE GOVERNMENT WAS THAT YOU HAVE COLLECTED THE DATA. THE DATA EXISTS, WHY NOT USE THEM FOR RESEARCH? >> RIGHT. >> YOU KNOW, THE RISK OF MISUSE OF DATA IS RELATED TO THE EXISTENCE OF DATA BUT NOT TO THE RESEARCH BASED ON THE DATA. I THINK THAT WAS THE STRONG ARGUMENT. >> AND THERE'S RISKS TO THE NON-CLINICAL SIDE EVEN WITHOUT THE RESEARCH. THERE'S MAYBE -- I MEAN, I COULD TALK TO YOU A LOT AT LENGTH. CANADA IS NOT AS UNIFIED AS YOU'D LIKE TO THINK. THERE IS A REALLY NEAT PROJECT IN PEDIATRICS IN ONTARIO, THE LAST PROVINCE HAS PROBABLY THE BEST DATABASE, TRUG AND LAB DATA. BUT I'D LIKE TO ASK YOU, THERE'S MORE QUESTIONS FROM THE AUDIENCE, I DON'T WANT TO HOG THE TIME, BUT TWO QUESTIONS ABOUT RESEARCH, SO CAN YOU TALK TO HOW THIS KIND OF DATABASE CAN BE USED FOR LARGE SIMPLE TRIALS OR PRAGMATIC TRIALS WHERE YOU DON'T MEASURE A LOT EXCEPT YOU WATCH THE DATABASE FOR OUTCOMES, YOU RANDOMIZE -- >> THE SAME STUDY I TALKED ABOUT, THEN THE PATIENTS WERE RANDOMIZED IMMEDIATELY WHEN THEY WERE ADMITTED TO THE HOSPITAL, AND THEN THEY -- A, B, AND THEN THEY TRANSFERRED THE INFORMATION TO A COMPUTER AND THEN THEY INVESTIGATED, THEY COLLECTED ALL OTHER INFORMATION FROM THE MEDICAL DATABASES. AND IT ALSO SEEMS THAT SOME OF THE SELF-REPORTED DATA, THEY ARE REALLY POOR DATA WHEN YOU COMPARE THE INFORMATION WITH THE MEDICAL REGISTRIES. FOR EXAMPLE, IF YOU SAY THAT YOU HAVE HAD AN APPENDICITIS 15 YEARS AGO, WE HAVE NOT BEEN ABLE TO FIND IT IN THE REGISTRY. AND IF THEY SAY THEY HAVE HYPERTENSION, WE ARE NOT ABLE TO FIND A DIAGNOSIS OF HYPERTENSION IN THE REGISTRY. BUT OF COURSE THERE YOU ARE SOME PROBLEMS AND THAT'S BASICALLY RELATED TO LIFESTYLE FACTORS AS ALCOHOL INTAKE AND SMOKING. >> THE OTHER QUESTION, HAVE YOU USED YOUR DATABASE TO RECRUIT PATIENTS INTO CLINICAL TRIAL? >> YEAH. >> YOU WANT TO TALK ABOUT THAT FOR A MINUTE? >> THAT'S EASY. WE ACTUALLY HAVE AN ORGANIZATION CALLED ONE ENTRANCE TO HELP INDUSTRY BY IDENTIFYING PATIENTS TO RANDOMIZED TRIALS, SO IF YOU -- IN OUR DEPARTMENT, WE HAVE A COORDINATOR, AND HER JOB IS TO RECEIVE A CALL FROM A DRUG COMPANY, WE WOULD LIKE TO CONDUCT A TRIAL BASED ON 150 PATIENTS WITH ULCERATIVE COLITIS, SHE CAN SEND A LETTER OR AN EMAIL TO THE PHYSICIANS AND THEN THE PHYSICIANS CAN INFORM THE PATIENTS AND THEY CAN ACCEPT TO PARTICIPATE. >> THE DEGREE OF SENSIBILITY IS AWE INSPIRING COMPARED TO WHAT WE FACE HERE. ONE OTHER POSITIVE THING, MEDICARE HAS CHANGED THEIR POLICIES A BIT, AND AT LEAST FEDERAL RESEARCHERS ARE GET AT THE DATABASE WITH MODEST BARRIERS, IF YOU WANT I CAN TELL YOU THAT AFTERWARDS. >> I THINK FROM NEXT WEEK, THERE'S A WEBSITE WHERE YOU CAN SEND AN EMAIL TO THE COORDINATOR AND THEN SHE CAN TELL YOU WITHIN 24 HOURS HOW MANY PATIENTS SHE HAS IN THE COMPUTER SYSTEM. >> THAT COULD BE GOOD. MOVE TO SCANDINAVIA. >> MAYBE YOU SAID THIS ALREADY AND I MISSED IT, BUT IS THE GENERAL PRACTITIONER DATABASE THAT YOU DESCRIBED, IS THAT SORT OF ENABLED BY USE OF A COMMON ELECTRONIC HEALTH RECORD ACROSS THE GENERAL PRACTITIONER COMMUNITY? >> THEY HAVE THE SAME -- SYSTEM ALL OVER THE COUNTRY, MANAGED BY ONE COMPANY. BUT THE COMPANY CAKING CARE OF THE DATABASE IS NOT THE ONE TAKING CARE OF THE MEDICAL RECORDS. ALSO FROM LAB SYSTEM, PATHOLOGY SYSTEM, FOO ONE LARGE QUALITY DATABASE. AN EXAMPLE COULD BE THAT IF YOU HAVE A PATIENT WITH DIABETES, ARE THEY REFERRED TO A SPECIALIST AND HOW MANY -- DO THEY HAVE OR HAVE THEY SEEN AN EYE DOCTOR? THAT'S THE KIND OF INFORMATION THEY COLLECT. BUT IT'S STRUCTURED IN A WAY THAT IT'S VERY DIFFICULT TO USE IT FOR RESEARCH PURPOSES. WE HOPE WE'LL GET MONEY TO CHANGE THAT SITUATION. >> THAT WAS GOING TO BE MY FOLLOW-UP QUESTION, WHETHER GIVEN A COMMON DATABASE OR COMMON EHR, YOU'VE HAD ANY SUCCESS WITH THE RESEARCHERS KIND OF INFLUENCING THE WAY DATA ARE COLLECTED TO MAKE IT MORE ACCESSIBLE OR USABLE FOR RESEARCH BUT IT SOUNDS LIKE THAT'S MORE OF A CHALLENGE FOR YOU. >> THANK YOU VERY MUCH, HENRIK, FOR COMING ALL THE WAY OVER HERE AN GIVING US THIS GREAT TALK. [APPLAUSE] >> THANK YOU.