>> GOOD MORNING, EVERYBODY. GOOD MORNING. I THINK WE SHOULD GET STARTED. I WAS JUST INFORMED THAT OUR COLLEAGUE, PAULETTE GRAY, IS STUCK IN TRAFFIC AND WILL NOT BE ARRIVING UNTIL A LITTLE BIT LATER. AS SUCH, I DO NOT HAVE MY VERY IMPORTANT SET OF NOTES THAT PAULETTE HANDS ME. >> I THOUGHT YOU MEMORIZED THEM BY NOW. >> DIRECTOR JACKS: SO THAT LITTLE PREAMBLE THAT I START WITH, I WILL HAVE TO IMPROVISE, WHICH BASICALLY SAYS WE CAN TOLERATE NO REAL OR PERCEIVED CONFLICTS OF INTEREST, SO IF YOU HAVE ANY, YOU MUST RECUSE YOURSELVES AND DEPART THE ROOM DURING SUCH DISCUSSION, AND OTHERWISE THE SECOND MOST IMPORTANT THING IS TO SHUT OFF YOUR CELL PHONES AND YOUR BEEPERS. OTHER THAN THAT, I THINK WE CAN GET STARTED. AND WE HAVE A VERY FULL AGENDA TODAY, SO WE'RE GOING TO REALLY TRY TO STAY ON TIME, AND I KNOW SEVERAL OF YOU HAVE PLANES AND TRAINS TO CATCH AND SO FORTH, SO I'M GOING TO BE TOUGH ABOUT THE SCHEDULE, AND EVEN AT THE OUTSET, WE'RE GIVEN A LITTLE TIME BACK BECAUSE HAROLD HAS TOLD ME THAT HE'S GOING TO KEEP HIS REMARKS QUITE BRIEF. SO WITH THAT, WE'LL TURN IT OVER OH TTO DR. VARMUS. >> THANK YOU, TYLER. I WOULD NORMALLY TELL PAULETTE THAT SHE SHOULD NOT HAVE DRIVEN, SHE SHOULD HAVE TAKEN THE METRO, EXCEPT THAT TODAY, AFTER 3 1/2 YEARS OF SPORADICALLY USING THE METRO WHEN IT'S TOO COLD TO RIDE A BICYCLE, MY METRO TRAIN SHUT DOWN AT THE FRIENDSHIP HEIGHTS STATION, INITIALLY I WAS TOLD WE'D BE PAUSING, QUOTE, MOMENTARILY. THEN WE WERE TOLD THAT SOMEBODY WAS ILL ON A TRAIN IN FRONT OF US, AND THEN WE WERE TOLD BECAUSE THAT PATIENT WAS ILL, OUR TRAIN IS NOW OUT OF SERVICE, PLEASE GET OFF. SO I FOUND A COLLEAGUE, WE TROTTED UPSTAIRS, WE FOUND A CAB QUITE QUICKLY AND I ACTUALLY ARRIVED ON TIME. SO MAYBE SHE SHOULD TAKE THE METRO. ANYWAY, WELCOME. I'D POINT OUT TO YOU THERE'S BEEN A FAIRLY SHORT INTERVAL BETWEEN OUR LAST MEETING AND THIS ONE SO I'LL TRY TO KEEP MY REMARKS CORRESPONDINGLY SHORT. I REMIND YOU THAT THE NEXT MEETING IS A JOINT MEETING WITH THE BSA, AND THAT WILL BE -- THAT WILL DISCOURSE AT GREATER LENGTH AT THAT TIME. TODAY I'M PLEASE TODAY SAY THAT THANKS TO THE HELP OF BOB CROW AND HIS COLLEAGUES, WE'RE HAVING BASICALLY A MINI SYMPOSIUM ON TOBACCO IN REMEMBRANCE OF THE 50TH ANNIVERSARY OF THE SURGEON GENERAL'S REPORT BUT ALSO TALK ABOUT A LOT OF INTERESTING NEW DEVELOPMENTS FROM E-CIGARETTES TO GLOBAL TOBACCO CONTROL AND THE PLACE OF TOBACCO CONTROL RESEARCH IN OUR PORTFOLIO. IT'S A MAJOR FEATURE OF OUR EFFORTS IN THE GLOBAL HEALTH CENTER, AND YOU'LL HEAR MORE ABOUT THAT. SO I THINK YOU'LL FIND THIS A VERY STIMULATING TOPIC AND CERTAINLY CENTRAL TO EFFORTS TO IT REDUCE CANCER INCIDENCE AND MORTALITY AROUND THE WORLD, AND I THINK ANY FURTHER INSIGHTS YOU CAN HAVE INTO HOW WE MANAGE THE TOBACCO PROBLEM WILL BE BENEFICIAL TO EVERYBODY. A COUPLE OF THINGS ABOUT PERSONNEL. ALWAYS LIKE TO START WITH THAT. WE HAD A MAJOR BODY BLOW TO ALL OF US ABOUT A WEEK AGO WHEN JOHN TAKOWSKI ANNOUNCED HE'S GOING TO RUN HARVARD, AND THAT MEANS BEING IN CHARGE OF THE RESOURCES PERSONNEL AND FINANCIAL AT HARVARD MEDICAL SCHOOL, THAT IS BASICALLY HARVARD THESE DAYS, AND JOHN HAS GIVEN GREAT SERVICE TO THE NCI AND AN INDISPENSABLE HELP TO ME AND MY COLLEAGUES. WE ALL CONGRATULATE HARVARD, ONLY WISH WE COULD PAY THE KINDS OF SALARIES HARVARD PAYS, BUT THIS IS A DEPARTURE AFTER MANY YEARS IN GOVERNMENT, I KNEW HIM IN BUILDING 1 IN THE 90s AND DESERVES SOME RESPITE FROM ALL THE CRAP WE GET IN GOVERNMENT. [LAUGHTER] YOU'RE AWARE COMMUNICATIONS IS A BIG ISSUE FOR THE NC O CI, JOHNSON HAS HEADED OFF FOR A GREENER INSTITUTE AT THE HEART, LUNG AND BLOOD, BUT WE HAVE NOW QUITE NICELY FILLED THE GAP AND RECRUITED PETER GARRETT WHO'S HERE TODAY WHO NOW RUNS THE COMMUNICATIONS OFFICE. PTER HAS A RICH HISTORY IN BOTH COMMUNICATIONS AND MEDICAL AFFAIRS, AS WE WERE ABLE TO RECRUIT HIM FROM THE OFFICE OF THE NATIONAL COORDINATOR THAT MANAGES THE MEDICAL I.T., AND PETER HAS SETTLED IN VERY WELL TO HELP ME WITH MY DEALINGS WITH THE PRESS, ESPECIALLY THE IMPORTANT MEMBERS OF THE PRESS, I'VE BEEN ABLE TO RECRUIT AT LEAST ON A PROVIS BASIS ANN TO MASS, WHO WATHOMAS, SPENT SEVERAL YEARS WITH ME AT SLOANE-KETTERING AND IS NOW COMING OUT OF RETIREMENT TO ASSIST ME IN DEALING WITH SOME DIFFICULT ISSUES WITH PRESS. ALWAYS NEED TO HAVE A FEW WORDS ABOUT BUDGET BUT I CAN'T GIVE YOU MANY DETAILS BECAUSE EVERYTHING IS SHROUDED IN A CONE OF SILENCE AT THE MOMENT, BUT THE IMPORTANT THING IS THAT WE DID GET AN APPROPRIATION BILL BEFORE JANUARY 15TH, WE AVOIDED ANOTHER SHUTDOWN. YOU ALL PROBABLY HEARD THE BIG MESSAGE IN GROSS TERMS, IT'S THE POST SEQUESTRATION, WHICH CLOB BERRECLOBBERED OUR BUDGET IN 2013. WE HAD PARTIAL RESTOR OF THAT LOSS. WE HAD TAKEN A HIT OF ABOUT $255 MILLION FROM SEQUESTRATION IN FY13 COMPARED TO 12, AND WE'VE GOT $144 MILLION BACK, SO THAT COULD BE CALLED TURNING THE CORNER, GOING IN THE RIGHT DIRECTION, OR COULD BE CALLED, HEY, THE GLASS IS STILL HALF EMPTY. SO DEPENDS ON HOW YOU LOOK AT IT. I CAN'T SHOW YOU AN OPERATING PLAN FOR NCI THIS IT YEAR, BUT THERE WILL BE NO DRAMATIC CH FROM EXPECTATION, BUT OBVIOUSLY HAVING MORE MONEY THAN WE HAD IN '13 IS A GOOD THING, BUT THE OPERATING PLAN APPROVAL HAS NOT YET COME FROM OMB SO I CAN'T GIVE YOU DETAILS. ONE THING ABOUT THE APPROPRIATION BILL WORTH EMPHASIZING IS THAT THE RESTRICTIONS ON TRAVEL AND MEETINGS ARE STILL IN PLACE, AND OMB HAS MAINTAINED OTHER KINDS OF RESTRICTION ON OUR FREEDOM OF MOTION, AND I THINK ONE THING THAT A SUBGROUP OF THE NCAB MIGHT WANT TO HAVE A LOOK AT, THIS IS NOT AN ISSUE THAT PERTAINS SOLELY TO NCI BUT TO ALL OF NIH, IS THE BURDENS PLACED ON OUR INVESTIGATORS, DIFFICULTY IN GETTING TO MEETINGS, ARRANGING MEETINGS, THESE ARE HAVING A CHANCE TO ASSEMBLE WITH SOME FREQUENCY WITH IMPORTANT COLLEAGUES FUNDAMENTAL TO THE CONDUCT OF SCIENCE. WE'RE A SCIENCE AGENCY, WE RUN SCIENCE ACROSS THE COUNTRY. IF PEOPLE CAN'T MEET AND DO SO FREELY AND PLAN FOR MEETINGS AND NOW NOT ONLY DOES ONE HAVE TO PLAN FOR MEETINGS BUT PLAN IN 150 DAYS IN ADVANCE. THE CONSEQUENCES CAN BE INTELLECTUAL AND EVEN FINANCIAL BECAUSE PEOPLE HAVE TO PAY LATE FEES AND HIGHER AIRPLANE RATES, WAITING FOR APPROVAL TO GO TO A SCIENTIFIC MEETING IS AN HE HAS PLACED AN UNFORTUNATE BURDEN ON THE NOTION OF BEING A GOVERNMENT EMPLOYEE DOING SCIENCE AND QUITE UNFORTUNATE. THERE WILL, OF COURSE, BEING A FY15 BUDGET IN THE NOT TOO DISA TANT FUTURE. IDISTANT FUTURE. THEY HOPE TO HAVE REAL APPROPRIATION BILLS BEFORE OCTOBER 1ST. THAT WOULD BE A DEPARTURE FROM THE CURRENT REALITY THAT WOULD BE MIND-BLOWING, BUT IT MIGHT HAPPEN. THERE IS, AS YOU KNOW, A CURRENT BUDGET PROJECTION AS OPPOSED TO APPROPRIATIONS, A BUDGET PROJECTION FOR THE WHOLE GOVERNMENT AS A RESULT OF THE WORK OF SENATOR MURRAY AND CONGRESSMAN RYAN THAT OUTLINES IN LARGE TERMS WHAT WILL HAPPEN IN 2015. THERE MIGHT BE SOME ADDITIONAL MONEY FOR THE NIH, THAT REMAINS TO BE SEEN, BUT I THINK WE CAN EXPECT TO BE MORE OR LESS IN '15 WHERE WE ARE IN '14, BUT THE PRESIDENT'S BUDGET PROPOSAL IS NOT GOING TO BE UNVEILED UNTIL PROBABLY MARCH 4TH. THAT IS MUCH LATER THAN USUAL, BUT THESE HAVE BEEN EXTRAORDINARY TIMES. SENATOR MIKULSKI WAS HERE THIS WEEK AND IN ADDITION TO THE HIGHLIGHT OF HER VISIT, WHICH WAS GETTING A LECTURE ON RENAL CANCER, SHE ALSO ADDRESSED THE MASSES, TWO OR THREE SCRAG ELING MEMBERS OF THE PRESS, OP THE ON THE TOPIC OF OUR BUDGETARY FUTURE, AND SHE ARGUED VOCIFEROUSLY FOR SUPPORTING NIH, AND SHE GOT DESERVED ACCOLADES FOR PUTTING A BILLION DOLLARS MORE IN OUR BUDGET THIS YEAR THAN LAST YEAR, 2 BILLION HAS BEEN TAKEN AWAY OVER THE LAST TWO YEARS, YOU GET A BILLION BACK, ONE HAND IS STILL MISSING, BUT WE DO CONGRATULATE HER FOR MOVING THINGS IN THE RIGHT DIRECTION. THERE ARE OTHER -- SOME OTHER CHANGES ON THE HILL WORTH POINTING OUT, NO MAJOR LEGISLATIVE ISSUES, BUT WE'RE LOSING TOM HARKIN, WHO'S BEEN THE HEAD OF BOTH OUR AUTHORIZING AND APPROPRIATING COMMITTEE. THAT'S A BIG BLOW. HE'S BEEN A STALWART FOR NIH FOR A VERY LONG TIME. I WOULD LIKE TO THINK THAT IN HONOR OF TOM HARKIN'S DEPARTURE, THIS YEAR'S CONGRESS IS GOING TO GIVE US AN EXTRA BILLION OR TWO, BUT THAT HASN'T YET BEEN RAISED AS A LIVELY CONGRESSIONAL ISSUE. JACK KINGSTON, WHO'S BEEN SERVING AS CHAIR OF OUR HOUSE APPROPRIATION COMMITTEE, IS RUNNING FOR THE SENATE, STILL FIGHTING FOR THE NOMINATION ON THE REPUBLICAN SIDE, BUT I THINK IT'S PRETTY CLEAR THAT HE WON'T BE HERE AS A MEMBER OF THE HOUSE, AT LEAST, IN THE NEXT CONGRESS, AND THERE WILL BE SOMEBODY TO REPLACE HIM AS CHAIR, THAT WILL BE AN IMPORTANT CHANGE. THREE OTHER FIGURES WHO HAVE PLAYED AN IMPORTANT ROLE IN GOVERNMENT'S RELATIONSHIP TO SCIENCE ARE LEAVING. THEY'RE ALL WORTH MENTIONING. ONE IS RUSH HOLT, A VERY GOOD FRIEND OF MINE, A TRAINED PHYSICIST, AND HAS ALWAYS CARRIED THE TORCH FOR SCIENCE OF ALL KINDS IN THE GOVERNMENT HAS DECIDED TO STEP DOWN. NOT ENTIRELY CLEAR WHAT HIS NEW PLANS WILL BE, BUT HOPEFULLY STILL A FIGURATIVE WATCH IN WASHINGTON. HENRY WACHSMANN, WHO'S BEEN A MAJOR FIGURE ON THE OVERSIGHT SIDE, PRIMARILY, BUT ALSO A TREMENDOUS SUPPORTER OF NIH, IS LEAVING, AND JOHN DINGELL, AS YOU ALL PROBABLY HEARD, HAS ANNOUNCED HIS DEPARTURE, ALTHOUGH THE RELATIONSHIP THERE HAS BEEN -- I DON'T KNOW HOW TO PUT THIS -- HOT AND COLD, IT HAS BEEN -- HE'S FUNDAMENTALLY A VERY STRONG SUPPORTER OF HEALTHCARE REFORM AND RESEARCH, AND HIS DEPARTURE WILL BE NOTED WITH INTEREST AS WELL. NCI IS OBLIGED TO PROVIDE A BYPASS BUDGET, AND SOME OF YOU WATCHING THIS CLOSELY MAY HAVE NOTED THAT THE FY14 BYPASS BUDGET PROPOSAL HAS NOT SEEN THE LIGHT OF DAY, AND IT WILL, IN FACT, SINCE FY14 HAS HAPPENED, IT WILL BE FOLDED IN TO A FY15 BUDGET REQUEST, AND THAT WILL BE DONE, WE HOPE, WITHIN THE NEXT FEW WEEKS, MORE OR LESS WHEN THE PRESIDENT UNVEILS -- SHORTLY AFTER THE PRESIDENT UNVEILS HIS REQUEST FOR '15. I WANTED TO MENTION A FEW OTHER ISSUES. AS TYLER INDICATED, MY REPORT IS GOING TO BE ON THE SHORT SIDE BECAUSE I DO WANT TO BE SURE WE HAVE PLENTY OF TIME FOR OUR MINI SYMPOSIUM ON TOBACCO, AS WELL AS REMARKS FROM SEVERAL OTHER FOLKS WHO ARE HERE. WITH YOU I DHERE. NCI HAD A STAFF RETREAT AS WE DO SEMIANNUALLY IN JANUARY. A COUPLE THINGS DISCUSSED, ACTUALLY IT WAS ONE OF THE BEST R WE'VE HAD, A LOT OF GOOD DISCUSSION, BUT TWO THINGS I WANTED TO DRAW TO YOUR ATTENTION AS BEING OF SPECIAL INTEREST. FIRST WE HAD A VERY GOOD DISCUSSION ABOUT DIVERSITY, ESPECIALLY IN THE INTERIM ROLE RESEARCH PROGRAM. NOT TOO SURPRISINGLY, WE FOUND THAT THE NUMBER OF UNDERREPRESENTED MINORITIES, E BLACKS AND HISPANICS, REMAINS WOEFULLY LOW IN THE INTRAMURAL RESEARCH PROGRAM, BUT ONE BRIGHT LIGHT HERE WAS THE RATHER ROBUST REPRESENTATION, ESPECIALLY OF AFRICAN-AMERICANS AMONG OUR POSTDOCS. 7 TO 10% OF OUR POSTDOCS HAVE B AFRICAN-AMERICAN FOR THE LAST SEVERAL YEARS. AND THAT'S A PRETTY SUBSTANTIAL GROUP OF HISPANIC FOLKS AS WELL, AND WE HAD TWO REALLY WONDERFUL AND INSPIRING TALKS BY MINORITY MEMBERS OF OUR STAFF, ONE YOUNG JUNIOR FACULTY MEMBER WHO IS HISPANIC AND AN AFRICAN-AMERICAN SENIOR POSTDOC, AND BOTH GAVE US A LOT OF INSIGHT INTO THE DIFFICULTY OF FINDING YOUR WAY TO NIH AND IN WORKING AT THE NIH, BUT ALSO AN OVERALL ENDORSEMENT OF WHAT WE TRY TO DO HERE, AND THE RESULT WAS WE PUT TOGETHER A GROUP HEADED BY JONATHAN WEISS AND WITH MANY OF OUR SENIOR STAFF REPRESENTED TO TRY TO TAKE ADVANTAGE OF SOME OF THE THINGS WE LEARNED AND I'M QUITE ENCOURAGED BY THE RESULTS O THEIR FIRST MEETING IN WHICH THEY LAY OUT A SERIES OF STEPS INCLUDING SOME SPECIAL TRAINING PROGRAMS AND GREATER EFFORTS IN RECRUITMENT AND RETENTION, AND I'M HOPEFUL THAT WE CAN MAKE IN THE TRAINING PROGRAMS, ANDDE TAKE ADVANTAGE OF SOME OF OUR EXTRAMURAL TRAINING PROGRAMS AS WELL, TO TRY TO ADJUST TO CURRENT REALITIES AND HAVE A BETTER REPRESENTATION OF ALL OF AMERICA'S ETHNIC GROUPS IN OUR INTRAMURAL PROGRAM. WE ALSO TALKED AT THE RETREAT ABOUT NEW WAYS TO THINK ABOUT CAREER PATHWAYS IN SCIENCE, ESPECIALLY SUPPORTED BY THE NCI. YOU'VE HEARD BEFORE ABOUT OUR EFFORTS TO CREATE A NEW OUTSTANDING INVESTIGATOR AWARD. THAT HAS STILL NOT BEEN RELEASED BECAUSE WE'RE STILL HOPING TO HAVE THAT BE A SEVEN-YEAR AWARD WITH AN OPPORTUNITY FOR VARIOUS TIME FOR EXTENSION BUT WE'RE GETTING A LOT OF PUSHBACK FROM THE DEPARTMENT ON THIS WHICH IS CURRENTLY NOT ALLOWING US TO ADVERTISE THE SEVEN-YEAR AWARD. WE'RE STILL WORKING TO MAKE THAT HAPPEN. P IIF IT DOESN'T, WE'LL END UP WITH A FIVE YEAR AWARD BUT WE'RE STILL IN THERE PITCHING. SOME OF THE NEW IDEAS INCLUDE RAN SITION AWARDS BETWEEN GRADUATE AND POSTDOC YEARS, TRAINING PROGRAMS THAT EMPHASIZE THE POSSIBILITY OF BECOMING STAFF SCIENTISTS AS OPPOSED TO INDEPENDENT FACULTY, A AWARDS THAT MIGHT EASE THE DEPARTURE OF SENIOR SCIENTISTS F THE SCIENTIFIC WORKFORCE, SOME DESPERATELY TRY TO HANG ON, THEY DON'T SEE A GRACEFUL EXIT, BUT A THESE THINGS NOT YET IN THE FORM OF FORMAL PROPOSALS, BUT I JUST WANT YOU TO KNOW WE ARE THINKING ABOUT THESE AND HAVE SOME FAIRLY SPECIFIC PROPOSALS FOR WAYS TO CHANGE THE WAY TRAINING AND SUPPORT DURING THE MOST VITAL TIME OF SOMEONE'S CAREER, AND EVEN PLANS TO THINK ABOUT HOW WE CHANGE DEMOGRAPHICS SOMEWHAT AND BY FINDING NEW WAYS PORE PEOPLFOR PEOPLE TO FINISH UP HAIR WORK AND EXIT THE SCIENTIFIC COMMUNITY. COUPLE OF OTHER ITEMS. THERE WAS ALSO A RETREAT OF ALL THE INSTITUTE DIRECTORS THAT OCCURS AT LEAST ANNUALLY. DURING THAT RETREAT, THERE WAS A FAIR AMOUNT OF DISCUSSION ABOUT THE SCIENTIFIC WORK FOR, HOW WE EVALUATE THEM, HOW WE SUPPORT THEM. THERE WERE A LOT OF NEW IDEAS ABOUT SUPPORTING CAREERS IN THE WAYS I'VE JUST MENTIONED BUT INCLUDING ESPECIALLY EFFORTS TO SUPPORT SCIENTISTS IN THE VERY EARLY STAGES OF THEIR CAREER, A THE PHASE BETWEEN THE FIRST GRANT AND RENEWALS. THERE WAS SOME DISCUSSION ABOUT THE EVALUATION PROCESS, INCLUDING PEER REVIEW, AND A DISCUSSION OF THE NCI BIOSKETCH PROPOSAL, WHICH HAS BEEN VERY FAVOR RECEIVED AND YOU'LL BE HEARING MORE ABOUT THAT FROM NIH CENTRAL IN THE NEAR FUTURE. MANY OF YOU HAVE BEEN FOLLOWING OUR RESPONSE TO THE RECALCITRANT CANCERS ACT. OUR REPORT ON PANCREATIC DUCTAL ADENOCARCINOMA HAS BEEN SENT TO THE HILL, WE'VE DISCUS IT BRIEFLY IN THE PAST. IF REQUESTED, WE MIGHT HAVE A MORE DETAILED PRESENTATION AT THE NEXT MEETING. WE HAVE ANOTHER REPORT ON SMALL CELL LUNG CANCER, ANOTHER THAT FITS THE CRITERIA FOR THE FIRST ROUND OF REPORTS ON SO CALLED RECALCITRANT CANCER THAT I'M NOT ALL THAT FOND OF BUT IT'S WORKING WELL. WE'VE HAD GOOD WORKSHOPS TO EXAMINE CERTAIN TYPES OF CANCER. I EMPHASIZE THAT A TYPE OF CANCER IS NOT A CANCER THAT ARISES IN A CERTAIN ORGAN, IT'S A CANCER THAT ARISES IN A CERTAIN LINEAGE IN THAT ORGAN, THAT'S THE BEST DEFINITION AT THE MOMENT. STEVE JOBS DID NOT DIE OF PANCREATIC DUCTAL ADD MOA CARCINOMA, VERY COMMON CONFUSION. VERY IMPORTANT TO MAKE THE SEPARATION BETWEEN CANCERS THAT ARISE IN DIFFERENT CELL LINEAGES, AND I WOULD ECHO THAT FOR THERE IS NO SUCH THING IN MY VIEW AS LUNG CANCER. THERE'S LUNG ADENOCARCINOMA, WHICH MY FRIEND OVER HERE STUDIES, SMALL DRE CELL LUNG CANCER, WHICH HE ALSO STUDIES BUT THEY'RE TWO DIFFERENT THINGS, WHICH I AGREE. I WANT TO ALERT YOU TO A NEW CAMPUS-WIDE EFFORT TO STU IT DI THE INTRAMURAL RESEARCH PROGRAM. THE GOALS OF THIS PROGRAM REMAIN A LITTLE MURKY TO ME, BUT IT'S ALWAYS HEALTHY TO EXAMINE THINGS AND BOB WILTROUT AND HIS COLLEAGUES HAVE BEEN WORKING WITH THE BOARD OF SCIENTIFIC COUNSELORS TO ESTABLISH SOME -- I'M NOT SURE THEY'RE STILL CALLED BLUE RIBBON, BUT PANELS THAT ARE LOOKING AT THE INTRAMURAL PROGRAM. NOW I THINK MY OWN VIEW IS THIS IS ON A VERY FAST TRACK FOR REASONS THAT STILL AREN'T ENTIRELY CLEAR TO ME, AND THE GOALS ARE NOT SO CLEAR EXCEPT IT'S ALWAYS GOOD TO LOOK AT THINGS, WELL, OKAY. I THINK OUR EMPHASIS IS GOING TO BE ON TRYING TO IDENTIFY PARTICULARLY IMPORTANT, EXCITING, DIFFICULT THINGS THAT THE INTRAMURAL PROGRAM MIGHT UNIQUELY TAKE ON. SO WHILE THERE WILL BE A GENERAL EXAMINATION OF PROCEDURES AND PEOPLE AND ALL THE REST OF IT, NOT AT A MICRO LEVEL OF THE SORT THAT'S DONE BY SITE VISITS BY THE BSC, BUT LOOKING AT OUR PROCEDURES AND THAT THE GENERAL CONSTITUTION OF THE PROGRAM AND WE HAVE A COMPLICATED PROGRAM WITH ESSENTIALLY THREE DIVISIONS, WORKING IN VARIOUS PLACES, BUT BEYOND THAT, LOOKING FOR OPPORTUNITIES TO DO SOMETHING, NOT UNLIKE WHAT WE'RE TRYING TO DO AT THE FREDERICK NATIONAL LAB. JENNIFER AND I PARTICIPATED RECENTLY IN A DISCUSSION WE HAD AT THE MEETING OF THE FREDERICK ADVISORY COMMITTEE WHERE WE WERE SPECIFICALLY VETTING PROPOSALS FOR NEW PROJECTS TO BE CARRIED OUT AT THE FRE FREDERICK NATIONAL LAB, NEW WAYS TO RUN THE FREDERICK NATIONAL LAB, I'D LIKE THIS TO BE A REVIEW OF THE INTRAMURAL PROGRAM, AND THAT WILL BE SOMETHING WE'LL REPORT ON AT EITHER THE NEXT OR THE ONE AFTER THE NEXT NCAB MEETING. PERHAPS WORTH MENTIONING, OF COURSE OUR INTRAMURAL PROGRAM HAS AS A MAJOR COMPONENT WORK AT THE CLINICAL RESEARCH CENTER, DISCUSSED WITH THE BUDGET COMMITTEE LAST NIGHT. THE FINANCIAL SUPPORT FOR THE CANCER -- FOR THE CLINICAL SN TER IS STILL A SOURCE OF CONCERN TO MANY INSTITUTE DIRECTORS AND THAT'S WHERE I THINK THE NCAB MIGHT BE ABLE TO PLAY A ROLE. THE NCI ACCOUNTS FOR ABOUT 40% OF THE RESEARCH ACTIVIN THE CLINICAL CENTER, FAR BEYOND WHAT WE MIGHT BE PREDICTED TO DO SINCE WEASINCE WE'RE ROUGHLY ONE-SIXTH OF THE NIH BY BUDGET COMPARISONS YET WE'RE 40% OF THE CLINICAL RESEARCH ACTIVITY. MAINTAINING THE VITALITY OF THE CLINICAL CENTER IS VITAL TO OUR RESEARCH EFFORTS, AND I'M CONCERNED ABOUT DEALING WITH THE FIXED COSTS OF THE CENTER AT A TIME WHEN OUR BUDGETS HAVE BEEN SHRINKING. THERE ARE A FEW OTHER THINGS THAT I'D BE HAPPY TO TAKE QUESTIONS ABOUT. I JUST MENTIONED THESE OTHER TOPICS BUT I DON'T WANT TO GET INTO TOO MUCH DEPTH, I WANT TO PRESERVE TIME FOR OTHER THINGS. YOU'LL RECALL THAT I'VE BEEN HELPING TO ORGANIZE AN ANNUAL MEETING OF CANCER RESEARCH FUNDERS, AND WE HAD THIS YEAR'S MEETING IN PARIS, LED BY CHRIS WILD FRO AND SOMEONE FROM THE FREN OF CH CANCER INSTITUTE, REPRESENTATIVES FROM ABOUT 20 DIFFERENT COUNTRIES WERE THERE, A NUMBER OF IMPORTANT NEW WORKING GROUPS ON THINGS FROM CONTROL OF CERVICAL CANCER TO TOBACCO CONTROL TO HARMONIZING CLINICAL TRIALS HAVE BEEN SET UP WITH REP OFTIVES FROM VARIOUS COUNTRIES, AND THE TOBACCO ISSUE WAS PARTICULARLY IMPORTANT BECAUSE AT THE SAME TIME WE WERE IN PARIS, NEW CANCER PLAN FOR FRANCE, WE HAD PETITIONED HIM AS A GROUP TO RAISE TAXES ON TOBACCO BECAUSE TOBACCO RATES HAVE NOT FALLEN IN FRANCE RECENTLY EVEN HOE THEY HAVE INSTITUTED SOME VERY GOOD EFFORTS TO CONTROL TOBACCO IN PUBLIC PLACES, INCLUDING RESTAURANTS, BUT HE DID NOT INCLUDE OUR RECOMMENDATION, NEVERTHELESS, IT WAS INTERESTING TO SEE THIS GROUP TAKE SOME POLITICAL ACTION. I WAS ALSO IN INDIA FOR A COUPLE OF WEEKS, OR A LITTLE OVER A WEEK, AND THERE ARE SOME MAJOR ISSUES WITH RESPECT TO CONDUCT OF CLINICAL TRIALS IN INDIA THAT WE MIGHT COME BACK TO AT A SUBSEQUENT MEETING. IT'S ONE OF THE THORNIER ISSUES IN GLOBAL HEALTH AT THE MOMENT BECAUSE ESSENTIALLY ALL NIH SUPPORTED INCLUDING NCI SUPPORTED TRIALS HAVE BEEN SHUT DOWN PENDING A REEVALUATION, RENEGOTIATION OF THE TERMS ON WHICH WE DO TRIALS IN INDIA. AND LAST I'LL JUST MENTION BRIEFLY SOMETHING THAT I'VE MENTIONED HERE BEFORE THAT A NUMBER OF INSTITUTIONS AND PEOPLE ARE TRYING TO ESTABLISH A GLOBAL ALLIANCE MOW CALLED GLOBAL ALLIANCE FOR GENOMICS AND HEALTH, SO G GA4GH, AND REPRESENTATIVES OF ABOUT 120 INSTITUTIONS WILL BE MEETING IN LONDON NEXT WEEK, INCLUDING SEVERAL PEOPLE FROM THE NCI, TO TRY TO WORK OUT THE MEANS TO ESTABLISH WAYS TO HAVE INTEROPERABLE DATABASES CONTAINING SOME OF THE RICH HOARD OF GENOMIC INFORMATION THAT'S BEEN DEVELOPED ESPECIALLY ABOUT CANCER, RARE GENETIC DISEASES, HOPEFULLY MICROBIAL DISEASES, AND TO SHARE THEM UNDER TERMS THAT ARE POLITICALLY AND ETHICALLY ACCEPTABLE. THIS IS A HUGE CHORE WHICH HAS BEEN LED BY A NUMBER OF PEOPLE IN U.S., CANADA AND ENGLAND ESPECIALLY, AND I'LL GIVE YOU A FULLER REPORT ON THAT AT OUR NEXT MEETING. DOUG AND JIM, DO YOU HAVE ANYTHING? THEY ARE SILENT TODAY. OKAY. IN RESPECT OF OUR TIME. ANY QUESTIONS? >> WE DON'T WANT TO STIFLE QUESTIONS, PEOPLE. WE DO HAVE TIME FOR DISCUSSION. WE ARE NOW AHEAD OF SCHEDULE, WHICH IS GOOD, AND PAULETTE HAS ARRIVED. WELCOME, PAULETTE. SHE'S NOT FEELING WELL TOO, BY THE WAY, SO CUT HER SOME SLACK. SHE DID FINALLY GIVE ME MY CHEAT SHEET, AND I INEVITABLY FORGOT A FEW THINGS SO I WILL NOW RECTIFY THAT. FIRSTLY, WE HAVE TO APPROVE THE MINUTES OF THE DECEMBER 10TH MEETING, 164TH MEETING OF THE NCAB. THEY'RE IN YOUR BOOK. I'M SURE YOU'VE HAD A CHANCE TO REVIEW THEM. ARE THERE ANY OMISSIONS OR CORRECTIONS TO THE MINUTES? MOTION, SECONDED. ALL IN FAVOR? OKAY. MOTION PASSES. THE OTHER THING I FAILED TO MENTION, AND THIS RELATES TO OUR LATER PORTION OF THE MEETING, THE CLOSED SESSION, I SHOULD HAVE TOLD YOU THAT THE DISCUSSIONS AND MATERIALS THAT ARE RELEVANT TO THAT ARE CONFIDENTIAL AND ARE GIVEN TO YOU ON A NEED TO KNOW BASIS, AND AS SUCH, THEY SHOULD BE KEPT PRIVATE AND THE CONTENTS NOT DIVULGED. WE'VE DRAWN YOUR ATTENTION ALSO TO THE FUTURE MEETING DATES, SO PLEASE MAKE SURE THOSE ARE IN YOUR CALENDARS. AND I ALSO WANT TO MAKE A STATEMENT ABOUT THE AGENDA. I'M PLEASED WITH TODAY'S AGENDA, WE'RE GOING TO HEAR FROM IT BARBARA RHYME RIMER SHORTLY AND BILL HAIT, THEN WE'RE GOING TO SPEND MOST OF THE AFTERNOON TALKING ABOUT TOBACCO IN VARIOUS ASPECTS, AND I THINK THAT WAS PARTLY DUE TO THE EFFORTS OF THE NCAB WHEN WE REQUESTED SUGGESTIONS, THAT THIS WOULD BE AN IMPORTANT AND MEATY TOPIC APPROPRIATE FOR THE NCAB. WITH RESPECT TO OTHER AGENDA SUGGESTIONS THAT ALL OF YOU MADE, THESE ARE BEING CONSIDERED FOR FUTURE MEETINGS, AND I THANK YOU FOR THAT AND IF YOU HAVE OTHER SUGGESTIONS, PLEASE DO PASS THEM ALONG. SO WITH THAT, LET'S MOVE ON TO THE FIRST PRESENTATION, WHICH IS FROM BARBARA RIMER, WHO IS, OF COURSE, A MEMBER OF THE PRESIDENT'S CANCER PANEL. SHE'S PRESENTED -- >> CHAIRPERSON. CHAIRMEMBER. >> DIRECTOR JACKS: YES, SHE IS GOING TO GIVE US AN UPDATE TO THAT WITH RESPECT TO THE HPV VACCINE. BARBARA, THANK YOU FOR BEING HERE. >> THANK YOU, TYLER. LET ME JUST PUT THIS ON. WELL, I'M REALLY HAPPY TO BE HERE TODAY, AND HAPPY TO TELL YOU THAT WE FINISHED OUR REPORT AND WE'RE PLANNING THE NEXT TOPIC. I HOPE YOU'VE HAD A CHANCE TO SEE IT ONLINE, BUT WE'LL TALK ABOUT IT A LITTLE BIT THIS MORNING. THAT'S THE TITLE OF THE REPORT, AND I'M JUST GOING TO WALK YOU THROUGH SOME OF THE RECOMMENDATIONS AND A LITTLE BIT ABOUT HOW WE GOT THERE AND JUST KIND OF THE DISCLOSURE ABOUT WHAT THE PURPOSE OF THE PCP IS, MONITORING THE DEVELOPMENT AND EXECUTION OF THE NATIONAL CANCER PROGRAM. I REALLY WANT TO GIVE TREMENDOUS CREDIT TO OWEN WITTY. HE REALLY IS AN AMAZING PARTNER IN THIS, AND HE'S BEEN TREMENDOUSLY HELPFUL. HE HAS BEEN ABLE TO ACT AT JUST THE RIGHT MOMENT AT SEVERAL POINTS INCLUDING BEING ABLE TO SEND THE REPORTS TO THE PRESIDENT THROUGH HIS EMAIL ADDRESS. SO I'VE TALKED TO YOU BEFORE AND THESE WERE THE WORKSHOPS THAT WE HAD TO FOCUS ON THESE ISSUES AND SEVERAL OF THE MEMBERS OF THE NCAB WERE THERE AS I REALLY WANT TO ACKNOWLEDGE ALL THE NCI DIVISIONS, INTRAMURAL AND EXTRAMURAL, WE GOT A LOT OF HELP, AND I'LL COME BACK TO SOME OF THE SPECIFIC PEOPLE A LITTLE BIT LATER. AND JUST TO REMIND PEOPLE, WE DID THESE WORKSHOPS VERY DIFFE FROM THE WAY THE PCP USED TO OPERATE, AND THOSE OF YOU ON THE NCAB WHO PARTICIPATED KNOW THAT. WE DO NOT TAKE TESTIMONY, WE HAD SHORT PRESENTATIONS THAT WERE SUBSTANTIVE AND SCIENTIFIC, THEN WE HAD SUBSTANTIVE DISCUSSIONS THAT HELPED US ARRIVE AT RECOMMENDATIONS. WE REALLY CAME TO -- AS WE LOOKED AT TOPICS, WE CAME TO THE BELIEF THAT INCREASING HPV VACCINATION IS REALLY ONE OF THE MOST PROFOUND OPPORTUNITIES FOR CANCER PREVENTION. I KNOW MICHAEL FIORE IS HERE AND WILL BE TALKIN TALK ABOUT TOBACCO. I THINK IF YOU PUT THE TWO OF THOSE ISSUES TOGETHER, THE OPPORTUNITY TO PREVENT CANCER IN THIS COUNTRY AND AROUND THE WORLD IS REALLY PHENOMENAL. AND I JUST WANTED TO READ YOU A COUPLE SENTENCES FROM A RECENT ARTICLE BY BOSCH IN "VACCINE." THEY SAID HPV IS AN EQUAL OPPORTUNITY PATHOGEN. IT IS PART OF THE HUMAN CONDITIO WELL ADAPTED TO INFECTING THE EPITHELIA AND SO PREVALENT AS TO BE ALMOST UNAVOIDABLE. AND THEY WENT ON TO TALK ABOUT THE FACT THAT WE NEED TO GET OUT OF THE THINKING THAT IT'S SOMETHING THAT PEOPLE BRING ON THEMSELVES BECAUSE OF THEIR BEHAVIOR THAT THIS IS -- THAT IT IS NOW SO WIDESPREAD THAT IT IS ALMOST UNAVOIDABLE. SO WE HAD A SERIES OF WORKSHOPS THAT REALLY FOCUSED ON SOME OF THE KEY ISSUES THAT WE'RE FACING. THE FIRST ONE WE LOOKED AT REALLY A LOT OF THE EPIDEMIOLOGICAL ISSUES, THEN WE LOOKED AT THE BEHAVIORAL AND COMMUNICATIONS ISSUES, AND THEN WE ASKED QUESTIONS ABOUT, OKAY, IF HPV VACCINATION BECOMES REALLY WIDESPREAD, THEN HOW WILL THAT INTERFACE AND CHANGE SCREENING? AND THEN WE TALKED ABOUT GLOBAL HPV VACCINATION AND SOME OF THE OPPORTUNITIES AND CHALLENGES, BECAUSE THIS IS A GLOBAL ISSUE. WITH 600,000 CASES OF HPV-ASSOCIATED CANCERS AROUND THE WORLD, THIS IS A GLOBAL HEALTH PROBLEM. WE'VE HAD REALLY GOOD RESPONSE TO IT. I'VE BEEN PARTICULARLY EXCITED ABOUT RESPONSE FROM A NUMBER OF THE ORGANIZATIONS THAT WE WORKED WITH, INCLUDING THE CENTERS FOR DISEASE CONTROL AND PREVENTION, THE AMERICAN CANCER SOCIETY, WE'VE BEEN INVITED A COUPLE TIMES AND THE PCP STAFF AND DOUG CAME WITH ME A COUPLE WEEKS AGO TO SPEAK TO THE NATIONAL VACCINE ADVISORY COMMITTEE, AND I THINK BECAUSE WE'VE WORKED WITH THE ORGANIZATIONS RIGHT THROUGH THE WHOLE PROCESS, PEOPLE ARE REALLY EXCITED ABOUT USING THIS REPORT TO MOBILIZE ACTION. SO THE BASIC PREMISE THAT WE WERE DEALING WITH IS THE FACT THAT WE HAVE TWO VACCINES AND WE'RE PROBABLY GOING TO HAVE A NON-VALENT VACCINE IN THE NEAR FUTURE THAT ARE EFFECTIVE, THAT HAVE VERY ACCEPTABLE SIDE EFFECTS, AND THEY'RE UNDERUSED. SO ONLY ABOUT A THIRD OF GIRLS, 113 TO 17, HAVE HAD THE THREE DOSE SERIES. SOME STATES ARE AS LOW AS 12%. AND LESS THAN 7% OF MAIL MALE MALES HAVE COMPLETED THE SERIES. IT WAS APPROVED FOR MALES LATER THAN FEMALES, SO WE WOULD EXPECT IT TO BE A BIT BEHIND, BUT THERE ARE ALSO A LOT OF REASON WHY IT HAS STAYED LOW. IT'S PARTICULARLY DISTURBING BECAUSE AS YOU LOOK AT OTHER ADOLESCENT VACCINES, WHICH WERE APPROVED MORE RECENTLY, LIKE THE MENINGEAL ONE, THE UPTAKE OF HPV JUST HAS NOT TAKEN OFF. THAT'S BEEN NOTED BY THE CDC AND MANY OF THE HEALTH PROFESSIONAL ORGANIZATIONS. I'M GOING TO COME BACK TO SOME OF THE REASONS FOR THAT. SO WE HAVE A PROBLEM. WE HAVE EFFECTIVE VACCINES THAT ARE BEING UNDERUSED. WE'RE NOT DOING SO WELL COMPARED TO OTHER COUNTRIES. SO AUSTRALIA, THE UNITED KINGDOM, PARTS OF CANADA ARE DOING BETTER THAN THE UNITED STATES. THERE ARE SOME GOOD REASONS FOR THAT IN TERMS OF SOME OF THE STRATEGIES THAT HAVE BEEN USED IN OTHER COUNTRIES, BUT WE REALLY HAVEN'T TAKEN IT ON AS A NATIONAL PRIORITY. SO ONE OF THE CONCLUSIONS THAT WE REALLY CAME TO IS THAT IT HAS TO BE A PRIORITY. WE HAVE TO HAVE STRATEGIES THAT ARE USED NATIONALLY TO FOCUS ON THIS. AND THE IMPACT CAN REALLY BE SEEN IN SOME OF THE RECENT ESTIMATES, SO SOME CDC ANALYSES ESTIMATED THAT IF WE COULD GET VACCINATION LEVELS TO THE CURRENT -- TO ABOUT 80%, WHICH IS WHAT YOU WOULD EXPECT AS A MINIMUM FOR OTHER ADOLESCENT VACCINES, THAT WE'D PREVENT AN ADDITIONAL 53,000 CANCERS AMONG GIRLS WHO ARE NOW 12 OR YOUNGER. AND WE'D PREVENT A NUMBER OF OTHER CANCERS INCLUDING ORAL, PHARYNGEAL AND GENITAL WARTS. LIKE TOBACCO CONTROL, AND I'M SURE MICHAEL WILL TALK ABOUT THIS A LITTLE BIT, THIS IS A MULTI-FACTORIAL PROBLEM, IT INVOLVES NOT JUST PHYSICIANS BUT IT INVOLVES COMMUNITIES AND PARENTS AND ADOLESCENTS AND THE PUBLIC HEALTH SYSTEM AS WELL AS THE PRIVATE SYSTEM. IT ALL HAS TO BE MADE TO WORK A LOT MORE EFFICIENTLY. SO WE WANTED TO HAVE A SET OF PARSE MOAN JUST GOALS, SO WE DEVELOPED THREE OVERARCHING GOALS. THE FIRST, TO REDUCE MISSED CLINICAL OPPORTUNITIES, REALLY COMES OUT OF DATA FROM THE CDC THAT SHOWS THAT ADOLESCENTS ARE IN THEIR -- THEY'RE SEEING PHYSICIANS AND THEY'RE NOT GETTING THE -- AND THEY'RE NOT GETTING THE VACCINE. IT BEEN ESTIMATED THAT IF PHYSICIANS GAVE STRONG RECOMMENDATIONS TO GET THE VACCINE, THAT WE'D SEE THAT ADOLESCENTS WOULD BE FOUR TO FIVE TIMES MORE LIKELY TO HAVE RECEIVED IT. IT'S THE SAME KIND OF LESSON THAT WE LEARNED IN THE TOBACCO DOMAIN. SO THEY'RE GOING INTO PHYSICIANS' OFFICES, HAVING OTHER VACCINES BUT NOT GETTING THIS ONE. SO IN ORDER TO REDUCE THIS MISSED CLINICAL OPPORTUNITIES, WE'VE ALSO RECOMMENDED INCREASING PARENTS, CAREGIVERS AND ADOLESCENTS' ACCEPTANCE OF VACCINES AND THEN MAXIMIZING ACCESS TO VACCINE SERVICES. I'LL TELL YOU A LITTLE BIT ABOUT HOW WE WANTED TO DO THAT. WE THOUGHT A LOT ABOUT THE FACT THAT COMMUNICATION INFORMATION, ALL THOSE KINDS OF THINGS, TEND TO BE VERY FRAGMENTED OVER MULTIPLE AGENCIES AND SOMETIMES MESSAGES THAT ARE DISCORDANT ARE CERTAINLY NOT MUTUALLY REINFORCING. SO WE RECOMMENDED THAT CDC SHOULD DEVELOP TEST ITS, DISSEMINATE AND EVALUATE THE IMPACT OF INTEGRATED COMPREHENSIVE COMMUNICATION STRATEGIES FOR PHYSICIANS AND OTHER HEALTH PROFESSIONALS. THEN I'LL COME TO THE PUBLIC SIDE OF IT. WE RECOMMENDED THAT CDC REALLY BE PUT IN CHARGE OF DOING THIS, AND THAT THEY'D BE GIVEN THE RESOURCES TO DO IT. IF YOU GO TO THEIR WEBSITE, YOU'LL SEE REALLY EXTENSIVE WELL DONE MESSAGES ABOUT THIS ISSUE. AND THAT PROVIDERS SHOULD STRONGLY ENCOURAGE VACCINATION WHENEVER OTHER VACCINES ARE ADMINISTERED. AGAIN, IT'S SIMILAR TO TOBACCO. IF AN ADOLESCENT COMES IN TO THE OFFICE, THEY SHOULDN'T GO OUT WITHOUT AT LEAST HAVING THIS ISSUE RAISED IF THEY'RE AN AGE-ELIGIBLE ADOLESCENT. WE SHOULD BE USING ALL THE MODERN RESOURCES OF ELECTRONIC HEALTH SYSTEMS, AND THEN IMMUNIZATION INFORMATION SYSTEMS, WHICH ARE VERY EFFECTIVE, WELL DEVELOPED SYSTEMS TO AVOID MISSED OPPORTUNITIES. SO THAT IF SOMEBODY GETS A VACCINE IN ANOTHER OFFICE OR AT THE PHARMACY OR AT SCHOOL, THAT THEY ALL BECOME PART OF THIS INTEGRATED REGISTRY. THEN ALTHOUGH THE COST PAYMENT FOR THESE VACCINES ISN'T THE MAJOR BARRIER, THERE ARE SOME LOOPHOLES THAT NEED TO BE CLOSED AND SO WE RECOMMENDED THAT HEALTHCARE PAYERS SHOULD REIMBURSE PROVIDERS ADEQUATELY FOR THE VACCINES AND FOR ADMINISTRATION. AND THE CURRENT MEASURES SHOULD INCLUDE THIS ONE. WE'VE COMMUNICATED WITH THE GROUP AND ABBY HAS BEEN VERY HELPFUL OH TO US IN DOING THAT, AND THAT THERE ALSO SHOULD BE A MEASURE FOR MALES. WE HAVE NOT HEARD FROM THEM YET ON THAT ONE. THEN THAT THERE SHOULD BE A HEALTHY PEOPLE 2020 VACCINATION GOAL FOR MALES. WE'VE TALKED TO HOWARD ABOUT THIS. THERE DOESN'T SEEM TO BE ANY REASON IT CAN'T HAPPEN, AND REALLY, IT SHOULD. SO WE'VE GOT THE PHYSICIAN HEALTH PROVIDER SIDE. WE ALSO RECOMMENDED THAT CDC SHOULD DEVELOP TESTS AND COLLABORATE WITH PARTNERS TO DEPLOY INTEGRATED COMPREHENSIVE COMMUNICATION STRATEGIES FOR PARENTS, OTHER CARRIERS AND ALSO ADOLESCENTS. ADOLESCENTS THEMSELVES SOMETIMES GET LEFT OUT OF THE COMMUNICATION MIX, AND REALLY EVEN WHEN THEY'RE NOT THE MAIN DECIDER, THEY SHOULD BE PART OF THE PACKAGE OF PEOPLE WHO ARE THE PART OF THE CONVERSATION. THEN WE TALKED ABOUT MAXIMIZING ACCESS TO VACCINATION SERVICES. WE SPEND A LOT OF TIME DEBATING HAD. WHEN I WENT INTO THIS TOPIC AND STARTED READING THE LITERATURE, I REALLY THOUGHT WE WOULD END UP RECOMMENDING SCHOOLS BE A SITE OF VACCINATION, AND THAT BECAUSE IT HAS WORKED IN AUSTRALIA, IT'S WORKED IN A NUMBER OF OTHER PLACES, PARTS OF CANADA THAT THE MORE WE LOOKED AT THE COMPLEXITY OF SCHOOLS IN THIS COUNTRY AND THE RULES THAT GOVERN SCHOOLS AND HOW LOCALIZED THEY ARE, THE TROUBLE GETTING PAYMENT IN SCHOOLS BECAUSE THEY'RE NOT NECESSARILY PROVIDERS IN VACCINE SERVICES, THE MORE IT SEEMED LIKE SOMETHING WE SHOULD KIND OF HOLD OUT IF OTHER WAYS OF DEALING WITH THIS PROBLEM DON'T RESOLVE IT. SO WE FOCUS ON PHARMACISTS AND RECOMMENDED THE STATE SHOULD ENACT LAWS AND IMPLEMENT POLICIES THAT ALLOW PHARMACISTS TO ADMINISTER VACCINES TO ADOLESCENTS, INCLUDING YOUNGER ADD LADOLESCENTS. MANY OF US, INCLUDING ME, ARE NOW USING PHARMACIES FOR FLU VACCINES AND OTHER VACCINES, AND THE NUMBERS HAVE REALLY BEEN GOING UP OVER THE LAST FEW YEARS. ADOLESCENTS IN MANY STATES, AS I'LL SHOW YOU, CAN GET OTHER VACCINES THERE, AND WHAT WE SAID IS, THE MEDICAL HOME IS WHERE IDEALLY THE FIRST VACCINE WOULD BE ADMINISTERED. BUT FOR TWO AND THREE, IT REALLY WOULD MAKE SENSE TO GIVE PEOPLE OPTIONS. WE HAD PEDIATRICIANS IN OUR MEETINGS, PARTICULARLY THE SECOND MEETING, AND THEY WERE VERY ON BOARD WITH THIS. TALKING ABOUT THE MEDICAL HOME IS THE BEST PLACE FOR THE FIRST VACCINE REALLY ALLEVIATED THEIR ANXIETY, BUT I MUST SAY, THE PEDIATRIC LEADERSHIP DOESN'T -- IS NOT HAPPY ABOUT THIS, AND WITH RECOMMENDATIONS FROM OTHER GROUPS THAT PHARMACIES BE AN OPTION. AND THEY CAME OUT WITH A STATEMENT IN THE LAST WEEK SAYING THAT RETAIL CENTERS ARE NOT A PLACE WHERE VACCINES SHOULD BE ADMINISTERED. I KNOW THAT MANY MEMBERS OF THE RANK AND FILE DO NOT A AGREE WITH THAT, AND I HOPE THEY SPEAK UP AND I'D LOVE TO HEAR FROM SOME OF YOU ALL IN A FEW MINUTES. WE TALKED ABOUT OVERCOMING REMAINING BARRIERS TO PAY FOR HPV VACCINES. AGAIN, IT'S NOT THE MAIN ISSUE, ABOUT 40% OF KIDS GET VACCINES PAID FOR THROUGH THE NATIONAL PROGRAMS, THE CDC ADMINISTERS. BUT THIS JUST LETS YOU SEE KIND OF THE BAKEDOWN OF STATES IN TERMS OF PAYING FOR ALLOWING PHARMACISTS TO ADMINISTER, AND ALMOST 40% OF STATES HAVE LAWS THAT PROHIBIT PHARMACISTS FROM ADMINISTERING VACCINES, INCLUDING MY STATE. THEFN THEN WE TALKED ABOUT -- WE HAD A SESSION THAT FOCUSED ON GLOBAL HPV VACCINATION. AND THAT IS OBVIOUSLY A REALLY BIG ISSUE BECAUSE CERVICAL CANCER GLOBALLY IS SUCH A HUGE PROBLEM. IF YOU LOOK ON THE LEFT, THE NUMBERS FOR GLOBAL CERVICAL CANCER, OR THE PERCENTAGE. SO THIS IS A REALLY MAJOR CHALLENGE, AND ONE THAT WE WERE TALKING ON THE WAY UP, THIS IS REALLY A -- THIS IS A PROBLEM WE CAN SOLVE. IF YOU THINK ABOUT SMALLPOX AND WHAT WE WERE ABLE TO DO WHEN THE WORLD DECIDED THAT IT WANTED TO END SMALLPOX, I THINK THIS IS AN ACHIEVABLE -- THIS IS ACHIEVABLE IF WE REALLY FOCUS ON IT. IT'S SOMETHING THAT WE CAN DO. AND IF YOU LOOK AT CERVICAL CANCER MORTALITY RATES, YOU CAN SEE THAT THE PROBLEM DRK OF COURSE WE HAVE A PROBLEM IN THE UNITED STATES, BUT IT'S SO MUCH LARGER IN OTHER PARTS OF THE WORLD, INCLUDING AFRICA. SO IN TERMS OF GLOBAL RECOMMENDATIONS, WE RECOMMENDED THAT THE UNITED STATES SHOULD CONTINUE TO COLLABORATE WITH THE GABI ALLIANCE, VACCINATION IN LOW INCOME COUNTRIES, BUT THEY HAVEN'T PAID MUCH ATTENTION TO MIDDLE INCOME COUNTRIES WHERE THERE STILL ARE CHALLENGES IN PAYING AND REALLY HAVING COMPREHENSIVE CANCER PLANS. I KNOW SOME PEOPLE IN DCCPS HAVE BEEN WORKING ON CANCER PLANS IN SOME OF THESE COUNTRIES, AND I THINK IT'S REALLY IMPORTANT WORK. AND TED TRIMBLE, OFTEN, AND HIS GROUP. SO WE ALSO IDENTIFIED SOME RESEARCH NEEDS, INCLUDING INVESTIGATING MORE CONVENIENT DOSING SCHEDULES, EXTENDED DOSING, FEWER DOSES, SOME PAPERS HAVE COME OUT IN THE LAST SEVERAL MONTHS ON TWO DOSES AND SOME COUNTRIES INCLUDING IN EUROPE HAVE ALREADY MOVED TO RECOMMEND A TWO-DOSE, DEVELOPING NEXT GENERATION VA VACCINES THAT HAVE BROADER PROTECTION AND ARE EASIER TO STORE AND ADMINISTER. EXPLAINING THE NATURAL HISTORY OF ORAL PHARYNGEAL HPV INFECTIONS. OF KEVIN AND OTHERS IN THE FIRST SESSION THAT WE HAD WERE REALLY -- REALLY EMPHASIZED THIS, TRYING TO HAVE AN UNDERSTANDING OF THE DISEASE MODEL THAT WOULD BE LIKE CERVICAL CANCER, IF WE EVER COULD GET THERE. DEVELOPING MORE EFFECTIVE WAYS TO COMMUNICATE ABOUT HPV-ASSOCIATED DISEASES. I KNOW WE HAD SOME DISCUSSIONS IN HERE ABOUT HOW DO YOU DEAL WITH MISINFORMATION, AND THERE'S BEEN SOME INTERESTING RESEARCH THAT HAS COME OUT IN THE LAST SEVERAL MONTHS SHOWING THAT IT'S A MUCH MORE TRICKY KIND OF COMMUNICATION THAN IT MIGHT APPEAR, JUST GOING OUT AND ADDRESSING THE NEGATIVE CAN ACTUALLY MAKE PEOPLE MORE SOLIDIFY NEGATIVE PERSPECTIVES MORE THAN YOU MIGHT THINK, AND SO IT'S A PRETTY COMPLICATED ISSUE, AND IT'S SOMETHING I WANT TO LOOK AT IN THE SESSIONS THAT WE'RE GOING TO HAVE ON COMMUNICATION. THEN LOOKING TO THE FUTURE, DETERMINING HOW BEST TO INTEGRATE HPV VACCINATION WITH CERVICAL CANCER SCREENING. SO WE ALSO DIDN'T WANT TO JUST STOP WITH RECOMMENDATIONS BUT WE WANTED TO THINK ABOUT HOW TO ACHIEVE THIS VISION. AGAIN RIGHT FROM THE START, I KNOW OTHERS SHARE THIS COMMITMENT, WE JUST DON'T WANT TO WRITE REPORTS THAT JUST, YOU KNOW, ARE ADDED TO PEOPLE'S SHELVES OR INBOXES OR WHEREVER THEY GO NOW. SO THAT WE RECOMMENDED THAT THE NATIONAL VACCINE ADVISORY COMMITTEE BE GIVEN RESPONSIBILITY TO MONITOR THE STATUS OF UPTAKE AND IMPLEMENTATION OF THESE RECOMMENDATIONS. THEN WE ALSO MADE A STATEMENT THAT IS DIFFERENT FROM WHAT OTHER PANELS HAVE DONE, AND WE'VE SAID THAT COMPATIBILITY IN COMBINATION -- TO MONITOR IMPLEMENTATION OF RECOMMENDATIONS WILL INCREASE THE LIKELIHOOD THAT THE REPORT WILL BECOME AGENTS AND ITS RECOMMENDATIONS WILL BECOME AGENTS FOR CHANGE. SO WHILE WE'RE MOVING ON TO ANOTHER TOPIC, WE WANT TO STAY -- CONTINUE SOME FOCUS ON THIS, AND IT'S BEEN REALLY GREAT MOUNTAIN LASIN THE LAST COUPLE WEEKS, A NUMBER OF PEOPLE FROM CDC HAVE WRITTEN UP TO US AND SAID WE ARE TAKING ON THIS ASPECT OF THE REPORT, AND THE NBAK IS DEBATING RIGHT NOW WHETHER TO USE OUR REPORT INSTEAD OF ONE THAT THEY WERE INTENDING TO WRITE. BRUCE GELLEN, WHO RUNS THE VACCINE PANEL, HAS SAID THAT HE HAS FELT LIKE FOR THE FIRST TIME, THE BRIDGE BETWEEN THE VACCINE COMMUNITY IN THIS SETTING AND CANCER HAVE -- THAT THAT HAS REALLY BEEN ESTABLISHED, AND DOUG HAS BEEN REALLY HELPFUL IN THIS. SO I'M REALLY -- I'M VERY GRATEFUL TO A NUMBER OF PEOPLE AND PARTICULARLY DOUG, WHATEV WE KNOW, DOUG HAS HELPED US UNDERSTAND THAT. I REALLY ALSO WANT TO ACKNOWLEDGE KNOLL BREWER THAT HAS DONE MORE OF THE BEHAVIORAL STUDIES THAN ANYBODY ELSE. SEVERAL PEOPLE ON THE NCAB WERE REALLY HELPFUL AND CO-LED SOME OF THE -- SOME OF OUR WORKSHOPS, A NUMBER OF PEOPLE FROM CDC WE WOULD CALL, WE WOULD GET ADVICE FROM THEM, THEY WERE REALLY FORTHCOMING AND REALLY HELPFUL. HEAD OF THE DOMESTIC POLICY COUNCIL AND GAVE US REALLY FABULOUS FEEDBACK A NUMBER OF TIMES INCLUDING ON THE DRAFT REPORT. SO I'M REALLY GRATEFUL, AND AS I SAID, INTRAMURAL AND EXTRAMURAL DIVISION DIRECTORS AND OTHERS AT THE NCI WERE REALLY HELPFUL TO US. SO I FEEL LIKE WE'VE OFFERED SOME RECOMMENDATIONS THAT ARE ACHIEVABLE, THAT ARE NOT -- THEY'RE NOT NECESSARILY EASY, BUT THEY ARE ACHIEVABLE AND WITHOUT A HUGE AMOUNT OF INVESTMENT. A LOT OF THIS IS ABOUT COMMITMENT AND MAKING THIS A PRIORITY. I MUST SAY, I NOW HAVE GRADUATE STUDENTS COMING TO ME AND WANTING ME TO BE ON THEIR DOCTORAL DISSERTATION COMMITTEES ABOUT HPV VACCINATION, SO I FEEL LIKE I'M GOING TO -- DEFINITELY GOING TO STAY INVESTED IN HAD IT TOPIC. SO -- INTELLECTUALLY, I THINK IT'S ONE OF THE MOST INTERESTING TOPICS WITHIN CANCER CONTROL, BECAUSE WE'VE GOT SOMETHING THAT WORKS, BUT IS BEING UNDERUSED, BUT THERE ARE ALSO SOME REALLY IMPORTANT SCIENTIFIC QUESTIONS THAT REMAIN TO BE ANSWERED. SO I WANT TO TURN REALLY BRIEFLY TO THE NEXT TOPIC. WE'RE GOING TO BE BRINGING ALONG SOME OF THE QUESTIONS THAT HAVE BEEN RAISED IN THE HPV AREA, HPV VACCINATION AREA INTO THIS ONE. COMMUNICATION IS HUGE, AS YOU KNOW, AND WE SPENT SOME TIME THINKING ABOUT WHERE TO FOCUS, AND WE DECIDED WE REALLY WANTED TO FOCUS ON COMMUNICATION OPPORTUNITIES THAT HAVE COME OUT OF THE DIGITAL ERA, DIGITAL TECHNOLOGIES, PARTICULARLY LOOKING AT SOCIAL AND PARTS PAYTIVE TECHNOLOGIES THAT NOW ARE ALLOWING USER-GENERATED CONTENT, ALLOWING PEOPLE TO CREATE THEIR OWN COMMUNICATIONS, B ALSO ARE PUTTING ORGANIZATIONS IN A VERY DIFFERENT PLACE FROM WHERE THEY'VE EVER BEEN BEFORE, BECAUSE THEY CAN'T COMPLETELY CONTROL THE MESSAGE. I THINK THAT'S A REALLY INTERESTING CHALLENGE FOR PEOPLE IN COMMUNICATION. I KNOW IT'S AN ISSUE FOR THE INSTITUTE. AS I SAID TO PAUL, I DON'T THINK WE CAN ANSWER ALL OF THE QUESTIONS ABOUT THE HOW COMMUNICATIONS ARE BEING USED IN GOVERNMENT, BUT WE CAN PROVIDE SOME DIRECTION THAT MAY HELP WITH SOME OF THOSE QUESTIONS. SO WE'RE GOING TO HAVE A WORKSHOP ON MONDAY, AND WE'VE INVITED SOME REALLY FABULOUS PEOPLE, I THINK, TO HELP US SHAPE THE DIRECTION OF AN OVERALL SERIES FOCUSED ON THE POTENTIAL OF NEW MEDIA TO IMPROVE THE CONTROL OF CANCER. WE HAVE A NUMBER OF PEOPLE WHO ARE VERY INFLUENTIAL IN THIS FIELD, INCLUDING SUZANNA FOX, WHO WE CONVINCED TO COME OUT OF THE SABBATICAL TO COME TALK TO US AND SHE'S REALLY EXCITED ABOUT IT. SOME PEOPLE WOULD HAVE BEEN PRs FOR NCI'S CANCER COMMUNICATION CENTER OF EXCELLENCE, AND OTHERS, A NUMBER OF PEOPLE FROM THIS INSTITUTE AND FROM THE NIH. SO IT'S A HUGE TOPIC AND WHAT WE REALLY NEED TO DO IS FIGURE OUT EXACTLY HOW TO NARROW THE TOPIC IN A MEANINGFUL WAY. I'D BE DELIGHTED TO ANSWER YOUR QUESTIONS ON EITHER THE HPV TOPIC OR COMMUNICATION. >> THANKS FOR THE PRESENTATION AND THE HARD WORK AND YOUR FELLOW PANELIST'S HARD WORK. IT'S VERY IMPRESSIVE ACTUALLY TO PULL THAT TOGETHER IN A RELATIVELY SHORT AMOUNT OF TIME, AND ALSO I'M IMPRESSED BY YOUR COMMITMENT TO SEE IT THROUGH, NOT JUST WALK AWAY FROM THE REPORT. >> THANK YOU. I SHOULD -- I REALLY WANT TO ACKNOWLEDGE THE NCI -- THE PCP STAFF, LISA, ABBY AND JEN, AND THEY'RE ALL HERE. THANKS. >> QUESTIONS FOR BARBARA. >> WELL, I JUST WANT TO ECHO TYLER'S COMMENTS. I THINK I TREMENDOUSLY APPRECIATE YOUR LEADERSHIP WITH THIS. I THINK IT'S AN EXCELLENT REPORT. THE EPIDEMIOLOGY OF THIS DISEASE IS CHANGING VERY, VERY RAPIDLY, ESPECIALLY IN THE DEVELOPED WORLD IN WAYS THAT WE STILL DON'T COMPLETELY UNDERSTAND. YOUR COMMUNICATION POINT IS VERY IMPORTANT, AFTER YOUR REPORT WAS ISSUED EARLIER, THE AMERICAN CANCER SOCIETY'S TAKE ON THAT AND THAT PUBLICITY WHICH WAS SOLELY FOCUSED ON THE NEED TO -- THERE'S NO MENTION IN ANY OF THE OTHER HPV-RELATED CANCERS. AND WE NEED TO CONTINUE TO FOCUS ON THE EPIDEMIOLOGY BECAUSE THE MORE WE LOOK AT IT, THE LESS WE UNDERSTAND, I THINK, ABOUT WHY THINGS ARE CHANGING SO RAPIDLY. WE DON'T HAVE GOOD EXPLANATIONS FOR THAT AND I THINK WE'RE GOING TO HAVE TO CONTINUE TO FOCUS ON THIS OVER THE NEXT SEL SEVERAL YEARS. >> I HOPE SOME OF OUR RESEARCH RECOMMENDATIONS WILL REALLY BE TURNED INTO GRANTS AND OTHER WAYS OF RESPONDING, AND I THINK THE ACS DID WHAT A NUMBER OF ORGANIZATIONS DID, WHICH WAS TO KIND OF FOCUS ON THE EASY PART OF IT, BUT NOT THE COMPLEX PICTURE. >> ACCOLADES TO THE OUTSTANDING EFFORTS AND PRODUCT. I DON'T KNOW WHETHER IT'S DESIGN BY NOT, BUT THE SEGUE INTO SOCIAL MEDIA ON THE HEELS OF AN HPV EFFORT IS -- BEING ABLE TO TWEET TO FOLKS ABOUT VACCINES AND REALLY LOOKING AT THAT AS A PILOT TO LOOK AT SOME OF THE SOCIAL MEDIA PERSPECTIVES. JUST ONE QUESTION, AS YOU KNOW I'VE BEEN VERY TROUBLED ABOUT TRYING TO DO THINGS IN OUR OWN HOME STATE, BUT I AGREE, SCHOOL VACCINATION IS FRAUGHT WITH MANY, MANY ISSUES, BUT WHAT ABOUT THE NEED OF CHECKING OFF THE HPV VACCINATION BOX TO ENROLL? AS LONG AS WE KNOW WE DO WITH OTHER VACCINES? >> WE LOOKED AT THAT, AND THERE IS SOME RESEARCH ON THAT AND THE RESEARCH IS COMPLICATED BY WHETHER STATES OR REGIONS USE OPT OUT OR OPT IN KINDS OF POLICIES. I THINK IT'S STILL SOMETHING TO BE CONSIDERED FOR THE FUTURE, BUT WE REALLY WANTED TO PUT THE EMPHASIS INITIALLY ON THE RETAIL PHARMACY AS AN OPTION OH, BUT I DO THINK IT'S -- WE DON'T SEE AN IMPROVEMENT IN A FEW YEARS, IT SHOULD BE CONSIDERED. >> THE ME NIN JOE COCCAL VACCINE, HAVING THAT TYPE OF REGULATION AGAIN NORMALIZES IT, SOME SENSE IT'S NORMAL FLORA, IT REALLY IS EVERYWHERE. I TELL FOLKS THAT ALL THE TIME. I THINK GETTING AWAY FROM IT BEING A VERY NEA VENEREAL DISEASE, AT THIS POINT IT'S JUST NORMAL FLO FLO NORMAL FLORA AND WHO GETS THE PROGRESSION BEYOND THAT. >> WE DID TALK ABOUT THAT SOME OF THE MEN NIN JEEL VACCINE HAS THE ISSUE OF PEOPLE'S FEARS ABOUT COMMUNICATING FROM ONE CHILD TO ANOTHER IN CLASS, AND THIS IS A SOMEWHAT DIFFERENT ISSUE, BUT THERE'S NO QUESTION THAT THE SCHOOL CHECKOFF IS AN IMPORTANT WAY OF GETTING SOMETHING DONE. >> VICTORIA. >> EXCELLENT, BARBARA. I JUST WAS CURIOUS ABOUT WHAT THE ARGUMENTS ARE AGAINST ADMINISTRATION, RETAIL ADMINISTRATION OF PHARMACIES. THERE ARE SOME PHARMACIES THAT NOW HAVE CLINICS, IN FACT MOST OF THEM DO IN INDIANA, IN THE METROPOLITAN AREAS. WHAT IS THE ARGUMENT? >> WELL, I MEAN, I THINK IT'S PROBABLY ULTIMATELY AN ECONOMIC ARGUMENT, BUT REALLY THIS SHOULD BE DONE ONLY IN THE PHYSICIAN'S OFFICES UNDER A PHYSICIAN'S ADMINISTRATION. I THINK IT'S AN ARGUMENT THAT HAS KIND OF RUN OUT AND I'VE SEEN CHANGES. IT WAS IN NORTH CAROLINA A COUPLE YEARS AGO, I THINK IT WILL BE BROUGHT BACK. PEOPLE DESERVE CONVENIENCE ON HAD ONE TOO, AND IT'S REALLY HARD -- GETTING FIRST ONE DONE IS ONE THING, BUT WE'VE SEEN IS A BIG GAP BETWEEN GETTING THE FIRST DOSE AND THE SECOND AND THIRD >> CVS RECENTLY ANNOUNCED THEY WERE GOING TO DISCONTINUE TOBACCO SAILINGS. SALES. I WONDER ON THE PLUS SIDE IF MAJOR PHARMACY CHAINS ARE INTERESTED IN BEING A FORCE OF CHANGE FOR THIS AND WHETHER THEY WERE -- HAVE YOU HAD DISCUSSIONS WITH CVS OR WALGREENS OR RITE AID? >> WE HAD SOMEBODY FROM -- I THINK IT WAS THE SECOND GROUP, BUT WE DIDN'T TAKE THAT ON BUT I ACTUALLY THINK THE TOBACCO PRECEDENT NOW MAY BE A GOOD OPPORTUNITY TO OPEN THE DOOR ON THIS. IT'S A REALLY GOOD COMMENT. >> THE SECOND GROUP I WONDERED ABOUT IS CERVICAL CANCER SURVIVORS, >> Dr. Anderson: OBVIOUSLY SURVIVORS,AND OBVIOUSLY THEY'RE THE BIGGEST PEOPLE OH TO RECOGNIZE THE BENEFIT OF THIS AND WHETHER THEY CAN BE A FORCE FOR EDUCATION AND CHANGE IN THE PEDIATRIC COMMUNITY WHICH THEY NORMALLY DON'T INTERACT WITH. >> THERE'S NO QUESTION THAT CERVICAL CANCER SURVIVORS CAN BE AN IMPORTANT FORCE FOR THE ISSUES ABOUT SOME OF THE VACCINATION, AND WE ACTUALLY HAVE A GROUP IN OUR STATE THAT'S TRYING TO DO THIS IN THE SOUTHERN REGION. I DON'T THINK THEY'RE AS WELL CONNECTED INTO PEDIATRICIANS' OFFICES, AND I THINK THAT'S ONE OF THE CHALLENGES HERE, THAT THESE ARE REALLY DIFFERENT COMMUNITIES, BUT THERE'S A LOT OF ROOM FOR ORGANIZATION AND FOR ADVOCACY. >> ANY FURTHER QUESTIONS FOR BARBARA? >> DOUG, IS THERE ANYTHING YOU WANT TO ADD? YOU'VE BEEN SO MUCH A PART OF THIS PROCESS. >> I JUST WANT TO ADD MY POSITIVE COMMENTS. THE GROUP DID AN AMAZING JOB AND MANY OF THE RECOMMENDATIONS ARE FEASIBLE, AND REALLY HELP IN TERMS OF INCREASING VACCINE UPDATE, WHICH IS WHAT THE GOALS WERE. I THINK THAT WHAT BARBARA AND OWEN AND HILLARYLY TRIED TO DO WAS TO MAKE SOMETHING THAT COULD BE ACTIONABLE AND PRACTICAL, AND I THINK THEY REALLY ACHIEVED THAT TO AN ENORMOUS DEGREE. >> WELL THANK YOU. AGAIN, YOU WERE INCREDIBLY HELPFUL TO US. >> WE'LL GIVE HAROLD THE FINAL WORLD. >> JUST ONE POINT ABOUT THE PHARMACY ISSUE THAT HASN'T BEEN MENTIONED THAT I THINK IS IMPORTANT, AND THAT IS GETTING RID OF THE PERCEPTION THAT THIS VACCINE HAS SAFETY ISSUES. BECAUSE I THINK PEOPLE'S PERCEPTION, THIS HAS TO BE GIVEN AT A DOCTOR'S OFFICE, THAT SENDS THE WRONG MESSAGE. >> YES, IT DOES. >> SOME OF YOU MAY KNOW IN INDIA, ONE OF THE THINGS I HAD TO DEAL WITH WAS THE CLOSURE OF A VACCINE TRIAL THAT IN PART WAS CLOSED, NOT ENTIRELY, BUT IN PART CLOSED BECAUSE THERE WERE THREE FEMALE DEATHS IN THE STUDY. ONE FROM AN AUTOMOBILE ACCIDENT, ONE WOMAN FALLING DOWN A WELL, ONE WOMAN DYING IN CHILDBIRTH. ALL CLEARLY UNRELATED TO THE VACCINE, EVEN THOUGH THEY RECEIVED THE VACCINE, BUT THE PERCEPTION WAS SO STRONG, OF COURSE INDIA HAS CERTAIN RULES ABOUT COMPENSATION AND RISK AND CONSENT THAT THIS IS STILL PERCEIVED IN MANY PARTS OF THE WORLD WHERE THE VACCINE IS DEEPLY NEEDED AS BEING A THREATENING VACCINE. I JUST WANTED TO SAY, BARBARA, WHEN WE FIRST TALKED ABOUT YOUR TAKING ON THIS JOB, I TOLD YOU IT WAS GOING TO BE A LOT OF WORK, YOU GET SOME DIVIDENDS. I CONGRATULATE YOU AND YOUR FELLOW MEMBERS. >> THANK YOU. >> GREAT. THANKS AGAIN, BARBARA. AND WE'LL LOOK FORWARD TO HEARING FROM YOU AGAIN. [APPLAUSE] >> ALL RIGHT. WE'RE GOING TO MOVE ON TO THE SECOND AGENDA ITEM, WHICH IS TO HEAR FROM BILL HAIT ABOUT THE ACTIVITIES OF THE CANCER CENTER'S WORKING GROUP. WHICH AGAIN WE'VE HEARD ABOUT IN OUTLINE FORM BEFORE, BUT BILL IS GOING TO PRESENT A MORE COMPLETE DESCRIPTION OF THE RECOMMENDATIONS. AS YOU ALL KNOW I'M GOING TO LET HAROLD SAY A FEW WORDS OF INTRODUCTION. IN AN IDEAL WORLD, WE WOULD DEAL WITH THE CANCER CENTER IN A VERY DIFFERENT WAY. CANCER CENTERS ARE PROBABLY THE MOST IMPORTANT SINGLE INSTRUMENT WE HAVE FOR EXEMPLIFYING THE VIRTUES OF THE NCI AROUND THE COUNTRY, PROVIDING A PLATFORM FOR MUCH O THE RESEARCH THAT GOES ON IN THE COUNTRY TO DEAL WITH CANCER, AND IT'S BECOME APPARENT OVER THE YEARS THAT THE BUDGETS FOR THE DIFFERENT CANCER CENTERS, OF WHICH THERE ARE NOW 68, DON'T NECESSARILY CONFORM TO WHAT IS GETTING DONE AND BEING DONE AS IT DOES TO THE CENTER'S HISTORY. IN AN IDEAL WORLD, WE'D HAVE BIG BUDGET INCREASES AND JUST RECTIFY MATTERS BY INCREASING THE BUDGETS OF THOSE THAT HAVE BUDGETS THAT ARE ON THE LOW SIDE. AND WHAT I ASKED THIS GROUP TO DO IS TO CONSIDER WAYS IN WHICH WE COULD RESTORE A GREATER DEGREE OF EQUITY AND CONFIDENCE IN THE PROCESS OF MAKING AWARDS IN A WAY THAT ALL KINDS OF CANCER CENTERS, AND THERE ARE MANY KINDS, HAVE WILL AGREE TO. BILL, WHO'S BEEN A CANCER CENTER DIRECTOR, NOW HAS STEPPED AWAY FROM THAT BUSINESS TO ENTER ANOTHER BUSINESS HAS DONE AN OPTIMAL JOB HERE IN TRYING TO BRING TOGETHER A NUMBER OF POTENTIALLY CON 10TIOU INDIVIDUALS ON A VERY CONTENTIOUS TOPIC AND PUT TOGETHER A SET OF RECOMMENDATIONS THAT WE'LL DISCUSS FURTHER AFTER HIS REMARKS. >> THANK YOU, HAROLD. WORDS CAN'T DESCRIBE HOW THRILLED I WAS WHEN YOU ASKED ME TO TAKE THIS ON. [LAUGHTER] BUT IT REALLY IS REMARK IMPORTANT FOR THE REASONS THAT I WANTED TO POINT OUT. YOU CAN SEE REPRESENTATIVES OF LARGE CENTERS, SMALL CENTERS, BASIC CENTERS, COMPREHENSIVE CENTERS, WHICH WAS REALLY FANTASTIC TO GET THEIR INPUT, AND KEVIN, AN NCAB MEMBER, PARTICIPATED. REALLY I WANT TO CALL OUT LINDA AND HER STAFF. THEY WERE JUST REMARKABLE. WE NEEDED LOTS OF DATA, LOTS OF MODELING. WE'RE NOT DONE YET, BUT THEY WERE TREMENDOUSLY RESPONSIVE TO THE NEEDS OF THIS GROUP. SO THE CHARGE FROM THE NCAB WAS T ASSESS WHETHER CURRENT FUNDING GUIDELINES FOR THE NCI DESIGNATED CANCER CENTER ARE APPROPRIATE AND SUFFICIENT. IF NOT, WHAT MIGHT BE CHANGED? AND WE SHOULD PROVIDE APPROPRIATE GUIDANCE ON POLICIES AND METRICS RELEVANT TO THE ALLOCATION OF FUNDS OF CENTERS IN A TIME OF FISCAL STRIN GENESEE. I THINK IT'S IMPORTANT THAT IN 2012, THE AMENDED GUIDELINES WERE WRITTEN AND ENACTED UPON IN 2013, AND JUST TO REPRESH YOUR MEMORY, THESE INTERIM GUIDELINES CAPPED THE CCSG AWARDS AT 6 MILLION AS CURRENT DIRECT COSTS, CCSG AWARDS OF LESS THAN $6 MILLION ARE ABLE TO REQUEST AN INCREASE OF 10% OR UP TO A MILLION, WHICHEVER IS GREATER. NEW CENTERS COULD REQUEST NO MORE THAN A MILLION. ALTHOUGH THIS WAS AN IMPORTANT STEP, IT DIDN'T ADDRESS SOME OF THE PROBLEMS THAT DR. VARMUS POINTED OUT TO US IN THAT WE ADDRESSED AS A WORKING GROUP. SO THE BACKGROUND, AND I DON'T HAVE TO TELL YOU THIS, IS THE CANCER CENTERS PROGRAM REALLY IS THE ENVY OF THE WORLD. THERE ARE REALLY FEW IF ANY COUNTRIES WHERE THERE'S THE SAME COMMITMENT TO EXCELLENCE IN MULTIDISCIPLINARY CANCER RESEARCH, PROMOTION OF TRANSLATIONAL SCIENCE TO REDUCE THE CHANCE OF BURDEN. FINALLY FOR OVER 40 YEARS, IT BRINGS ENORMOUS BENEFITS TO THE HEALTH OF AMERICANS AND THE CENTERS ARE A MAJOR PLATFORM FOR ADVANCING NATIONAL PRIORITIES IN CANCER RESEARCH, AND INVESTIGATORS IN CANCER CENTERS HOLD A LARGE PROPORTION OF EXTRAMURAL NCI FUNDING. THE OTHER THING THAT COMES OUT VERY CLEARLY IN DISCUSSIONS WITH THE CENTER DIRECTORS IS THAT THE RIGOROUS REVIEW MAKES DESIGNATION MEANINGFUL AND PRESTIGIOUS, IT'S THE IMPRIMATUR THAT CAN LEVERAGE OTHER SOURCES OF SUPPORT. AND OF COURSE THE CCSG AWARD PROVIDES ESSENTIAL SUPPORT FOR INFRASTRUCTURE THAT ACTUALLY SPANS THE SPECTRUM OF CANCER RESEARCH. SO THAT'S THE BACKGROUND. AND OUR OVERALL ROLE IS TO CONSIDER THE FUNDING POLICIES FOR THE CENTERS AND, IF APPROPRIATE, RECOMMEND CHANGES. THE PROBLEM THAT YOU ALL RECOGNIZE, THE NCI LEADERSHIP RECOGNIZES, WAS THE COMPLEX HISTORICAL FUNDING PATTERNS THAT INFLUENCE CURRENT CCSG AWARDS. AS HAROLD POINTE OUT, HOW DO WE GET TO THESE DISPARITIES, WHAT OTHER APPROACHES COULD EXPLORED? SO SO DR. VARMUS HAD SPECIFIC QUESTIONS FOR US, ARE TH GUIDELINES SUFFICIENT AND APPROPRIATE, CONCERNS ABOUT THE CURRENT DISTRIBUTION AND IF NOT, SHOULD WE LOOK AT CHANGING THE CAP, LAUNCHING THE CENTERS WITH LARGER OR SMALLER BUDGETS, SHOULD WE MAY CHANGES THAT ALLOW FOR DIFFERENT ALLOWABLE RATES OF INCREASE, ARE THERE BETTER METHODS FOR MAKING FUNDING DECISIONS? IF SO, WHAT METRICS SHOULD BE USED AND HOW MUCH CONSIDERATION SHOULD BE GIVEN TO WAYS IN WHICH CORE FUNDS ARE USED? AND FINALLY ARE THERE WAYS TO MAKE BUDGETING MORE FLEXIBLE, SUPPLEMENTS, COOPERATIVE AGREEMENTS, WHAT WOULD BE THE APPROPRIATE USE OF THESE ALTERNATIVE RESOURCES. SO OUR GROUP AS YOU SAW INCLUDED 10 MEMBERS FROM DIVERSE CENTERS. WE MET SIX TIMES OVER A YEAR, WE HEARD PRESENTATIONS FROM NCI LEADERSHIP. WE REVIEWED A LOT OF DATA IN CURRENT FUNDING POLICIES AND APPROACHES, AND WE QUICKLY DREW SOME CONCLUSIONS. AND WE DISCUSSED MULTIPLE POSSIBLE APPROACHES, INCLUDING VARIOUS FUNDING P MODELS, AND THEN MUCH TO SOME OF OUR SURPRISE, WE ALIGNED VERY, VERY QUICKLY ON SOME RECOMMENDATIONS THAT WE'LL TALK ABOUT TODAY. SO THIS IS THE GENERAL CONCLUSION BEFORE WE REACHED THE RECOMMENDATIONS. SO SIGNIFICANT DISPARITIES EXIST IN THE SIZE OF THESE AWARDS. AND THESE DISPARITIES, THEY'RE OFTEN DUE TO FACTORS OTHER THAN MERIT. AS HAROLD POINTED OUT, ONE OF THE KEYS IS LONGEVITY. SO IF YOU'VE BEEN IN FOR 40 YEARS, EVERY TIME YOU COME IN, YOU ASK FOR AN INCREASE WHICH IS A ACCRETIVE TO THAT BUDGET, YOU MAY GET DISPROPORTIONATELY LARGE NUMBERS COMPARED TO A SUPERB CENTER COMING IN FOR THE FIRST TIME. THERE'S ALSO THE ISSUE OF WHEN YOU COME IN. THE VAGARIES OF THE NCI BUDGET THAT YEAR, THE CYCLE WHO YOU'RE UP AGAINST, ARE THERE A LOT OF BIG CENTERS IN, AND THE ISSUES OF PRIOR PERFORMANCE. WE FELT THAT THE 2012 GUIDELINES DID MANAGE SOME -- IN A VERY IANT WAY EXPECTATIONS, ESPECIALLY IN TIMES OF STRAIN STRINGENCY BUT REALLY DIDN'T GET TO THE HEART OF THE DISPARITIES AND I THINK THAT'S WHY YOU HAROLD AND YOU ALL HAVE ASKED US TO LOOK AT THIS. WE AGREE CENTERS DIFFER IN TYPE, STRUCTURE AND ENVIRONMENTAL FACTORS, AND THE CENTERS SHOULD BE EVALUATED ON WHAT THEY DO AND HOW WELL THEY DO IT. THE IMPACT ON SCIENCE EMERGING IFROM THE CENTER, NOT THINGS THAT THEY DON'T DO, WHICH HAS BEEN SWSOMEWHAT OF A PROBLEM. THERE'S ALSO COMPLAINTS OF ADMINISTRATIVE BURDEN, WHICH I KNOW THAT THERE ARE, AND DO WE FIND WAYS TO BE MORE FLEXIBLE IN TERMS OF USE OF THE FUND AND ALWAYS FOCUS AND STRESS THE MOST SIGNIFICANT SCIENCE. THEN THE ISSUE OF UNDERPERFORMING CENTERS HISTORICALLY, VERY UNUSUAL FOR A CENTER NOT TO BE REFUNDED. THERE WAS A DISCUSSION OF THESE CENTERS THAT ARE PERENNIAL UNDERPERFORMERS, SHOULD WE CONSIDER CESSATION OF FUNDING OF THOSE. THERE'S THE ADDED COMPLEXITY OF SUPPLY AND DEMAND FUNDING. NCI FUNDING HAS DECREASED, MAY REMAIN FLAT IN COMING YEARS, ALTHOUGH WE HAD SOME VIEW OF OPTIMISM THIS MORNING. YET THERE IS THIS DEMAND FROM UNIVERSITIES THAT THEY WOULD LOVE THEIR CANCER CENTERS TO HAVE NCI DESIGNATION. NCI HAS IMPERATIVES TO SUPPORT GEOGRAPHICALLY DISTRIBUTED CENTERS. I THINK THE ORIGINAL MANDATE WAS THAT NO PATIENT SHOULD BE FURTHER THAN TWO HOURS FROM A CENTER, WHICH IS QUITE A CHALLENGE, AND THE IMPORTANCE OF ACCESSIBLE FOR SPECIAL POPULATIONS. I MENTIONED THESE AWARDS ARE RARELY TERMINATED, AND AS A RESULT, THE NUMBER OF CENTERS CONTINUE TO GROW AND THE BUDGET CONTINUES TO BE STRESSED. SO WE REACH CONSENSUS, WE DISCUSS A VARIETY OF APPROA TO ADDRESS THESE DISPARITIES, AND WE WENT THROUGH A VARIETY OF MODELS. LET ME GO THROUGH SOME OF THE RECOMMENDATIONS, WHICH WE'RE STILL FINE-TUNING. SO FIRST, THIS FIRST ONE IS REALLY CRITICALLY IMPORTANT, THAT THE FUNDING SHOULD BE COMPRISED OF THREE COMPONENTS, A BASE, A MULTIPLIER OF THE BASE, PREDICAED ON MERIT AND SIZE AND A POSSIBLE SUPPLEMENT. I WILL GET BACK TO THIS ONE IN A SECOND. THE OTHER IMPORTANT RECOMMENDATION IS THAT WE NEED THE CENTER ADMINISTRATORS TO BE INVOLVED IN THE PLANNING FOR THE IMPLEMENTATION AND COMMUNICATION OF THIS NEW A APPROACH, IF IT'S GOING TO BE SUCCESSFUL. FINALLY, THESE CHANGES NEED TO BE FRAMED NOT FOR ANY REASON OTHER THAN THE MISSION OF THE NCI. IT'S NOT NEARLY BECAUSE WE ARE EXPERIENCING TOUGH TIMES, IT'S REALLY AN ISSUE OF EQUITY. WE THINK PROPER COMMUNICATION WILL HELP DETERMINE THE ACCEPTABILITY. SO LET ME GO THROUGH RECOMMENDATION NUMBER ONE. AND HERE IS THE CRUX OF THE ISSUE, THE BASE AWARD. SO WHAT WE'VE AGREED UPON IS THAT THERE WILL BE A BASE AWARD BASED ON THE TYPE OF CENTER, BASIC, CLINICAL OR COMPREHENSIVE, AND THAT WILL BE THE STARTING POINT FOR EACH RENEWAL. IN OTHER WORDS, THE RENEWAL WILL NOT BE ACCRETIVE TO THE HISTO FUNDING OF THE CENTER. AND HA THIS SHOULD -- THE BASE, IN TERMS OF CANCER CENTER, NCI CANCER CENTER'S BUDGETING, SHOULD BE ABOUT 50% OF THE BUDGET. THAT RENEWAL, AS I MENTIONED, THIS BASE AWARD WILL BE APPLICABLE TO ALL CENTERS OF THE SAME TYPE. THAT WOULD BE THE NEW STARTING POINT. THAT WAS AN INTERESTING HURDLE OH GET OVER, BUT THERE IS CONSENSUS, WHICH WE'RE VERY PLEASED SO SEE. THEN A MERIT COMPONENT. WE LOOKED AT A VARIET OF WAYS TO IMPLEMENT THIS, WE LOOKED AT CURVILINEAR SCALES, LINEAR SCALES, WE'RE STILL LOOKING AT FINE-TUNING THIS, BUT IF WE LOOKED AS A LINEAR SCALE AS A PERCENT MULTIPLIER OF THE BASE USING AN IMPACT SCORE, THAT SEEMED TO WORK, AND I'LL SHOW YOU AN EXAMPLE OF THIS MODELING, HOW THAT WORKS, AT LEAST HOW IT LOOKS IN TERMS OF CORRELATION TO MERIT. THEN THE SIZE COMPONENT, LOTS OF DISCUSSION, HOW DO YOU DETERMINE SIZE. WE AGREED UPON A FIGURE THAT WE WOULD USE WOULD BE CALCULATED BASED ON TOTAL PEER REVIEW FUNDING SUPPORTED BY THE CENTER. BELIEVE ME, THERE WAS LOTS OF DISCUSSION ABOUT CANCER- RELATEDNESS AND THE GROUP FELT WE SHOULD INTERPRET IT BROADLY BECAUSE YOU JUST DON'T KNOW WHERE THE NEXT IMPORTANT DISCOVERY WILL COME FROM. SUPPLEMENTS, STILL SOMETHING WE'RE WORKING THROUGH. IT WOULD BE BASED ON REVIEW OF PROPOSED HIGHLY INNOVATIVE AND IMPACTFUL PROGRAMS, COURSE, NEW INITIATIVES, AND CONSISTENCY WITH NCI PRIORITIES. SO HERE'S A MODEL, THIS IS ONLY A MODEL THAT WE LOOKED AT USING A LINEAR SCALE. YOU CAN SEE, I HOPE, THE GRAY BOXES, THAT'S THE CURRENT DISTRIBUTION OF CANCER CENTERS AS DIRECT COST AS A FUNCTION OF MERIT. YOU CAN SEE THE COEFFICIENT IS A WHOPPING 0.35. WITH THE NEW MODEL, AND AGAIN IT'S JUST MODELING BY THE CENTER, THOSE ARE THE RED DIAMONDS. AS YOU CAN SEE, IT'S IMPROVING. WHERE THERE'S A BETTER CORRELATION BETWEEN THE FUNDING AND THE MERIT WITH A MUCH BETTER COEFFICIENT. SO WE'RE MOVING CLEARLY IN THE RIGHT DIRECTION. MORE FIN FINE-TUNING CAN BE DONE. ALSO WANTED TO MAKE SURE WHAT EVERYONE UNDERSTOOD WHAT THE ?RITSPLITS ARE, HOW THEY UTILIZE THEIR BUDGET. AND YOU'LL SEE IT'S NOT EXACTLY HOW IT TURNS OUT FOR AN INDIVIDUAL AWARD. FOR EXAMPLE, IF THERE WAS 160 MILLION AVAILABLE TO THE CENTER'S BRANCH FOR THESE CCSG AWARDS, 50% WOULD COVER THE BASE, 30% WOULD COVER THE MERIT COMPONENT, AND 15 WOULD COVER THE SIZE/COMPLEXITY COMPONENT. WHEN YOU ADD THEM UP, YOU SEE WE LEFT OUT THE 5% FOR SUPPLEMENTS. SO THAT'S THE WAY THE CENTERS BRANCH WOULD HANDLE IT, AND IF YOU LOOK AT AN INDIVIDUAL AWARD, IT WON'T NECESSARILY HAVE THE SAME PROPORTION, SO FOR EXAMPL THESE WILL VARY BASED ON THE CENTER TYPE. SO FOR EXAMPLE, A LARGE CENTER, COMPREHENSIVE CENTER WITH A VERY GOOD IMPACT SCORE MIGHT RECEIVE 4.2 MILLION TOTAL, WHICH WOULD BE THE BASE OF 1.2 MILLION, EVERYONE IN THAT CATEGORY WOULD COMPETE FOR. A MERIT BASED ON A VERY GOOD IMPACT SCORE AND A SIZE COMPLEXITY AWARD. SO WHEN A VERY GOOD, VERY LARGE CENTER OF THE BASE ACTUALLY BECOMES A SMALLER PERCENTAGE OF THE TOTAL, AS YOU CAN SEE HERE. SO SECOND RECOMMENDATION, AND THAT IS THAT THE ADMINISTRATORS WILL PLAY A VERY IMPORTANT ROLE, THE CANCER CENTER ADMINISTRATORS, IN MAKING THIS WORK AND HELPING HONE IT EVEN FURTHER. THEY NEED TO EVALUATE, PREPARE FOR AND COMMUNICATE POTENTIAL CHANGES POTENTIALLY FOR CENTERS WHERE THEY'RE GOING TO BE SOME POSSIBILITY OF REDUCTION. WE NEED TO COMMUNICATE WITH NCI CENTERS PROGRAM STAFF ON IMPLICATIONS OF FUNDING CHANGES. SO THERE WILL BE UNANTICIPATED CONSEQUENCES OF THIS THAT THE W GROUP JUST COULDN'T ANTICIPATE YET, BUT WITH THE CENTER ADMINISTRATORS INVOLVED, THIS SHOULD BE HELPFUL AS WELL. AND THE FINAL RECOMMENDATION IS THAT THE TIMELINES, HOW WE IMPLEMENT THIS, HOW WE COMMUNICATE THESE CHANGES, WILL BE VERY, VERY IMPORTANT. VERY, VERY IMPORTANT. AND SHOULD BE GIVEN THE OPPORTUNITY ON HOW WE IMPLEMENT THESE PLANS. SO WHAT DO WE ANTICIPATE? WELL, WE THINK WE ANTICIPATE BETTER EQUITY, THAT THIS ADDRESSES THE PROBLEM OF ACCRETION, SINCE EACH RENEWAL WILL RECOMPETE FOR A PREDETERMINED BASE AWARD, AND THAT AWARD IS APPLICABLE TO ALL CENTERS OF THE SAME TYPE, AND THAT WILL HELP US GET AWAY FROM SOME OF THE HISTORICAL PROBLEMS. IT NEGATES THE NEED FOR CAPS SINCE PLAYING FIELD WILL BE LEVELED BY FORMULA-BASED BUDGETING AND ALSO TAKES INTO ACCOUNT MERIT, SOMETHING VERY, VERY IMPORT THERE'S A LIST OF POTENTIAL PROBLEMS AND HOW THEY MIGHT BE ADDRESSED. IT DOESN'T FULLY ADDRESS THE VARIATIONS AND THE SIZE OF THE NCI BUDGET. WE THINK IT WILL BE MINIMIZED OVER TIME. WE KNOW THAT FOR CERTAIN CENTERS, SOME OF THE CENTERS, ESPECIALLY THE MATRIX LARGE CENTERS, THIS COULD BE A PROBLEM BECAUSE THEY ARE PERHAPS MORE DEPENDENT ON THE CCSG THAN A LARGE FREE-STANDING WHERE THEY HAVE A LOT OF OTHER LEVERAGE TO PULL TO HELP FUND THEIR CENTER. THE OTHER THING WE REALLY WANT TO KEEP AN EYE ON, DOES THIS EVENTUALLY ACCRUE TO THE BENEFIT TO GREATER BENEFIT THE CANCER PATIENTS. AND THIS IS SOMETHING WE JUST HAVE TO MONITOR. SO WILL IT ALSO POTENTIALLY GENERATE ALARM AMONG CENTERS AND CONSTITUENTS? IT IS VERY POSSIBLE THAT SOME OF THE LARGER CENTERS WILL ACTUALLY HAVE A DECREASE IN THEIR BUDGET, AND WE HAVE TO BE VERY CAREFUL HOW THAT'S INTERPRETED, NOT AS A DECREASE IN QUALITY BUT RATHER A WAY TO ADJUST MORE FAIRLY HOW THE AWARDS ARE MADE. SO IN SUMMARY, AGAIN, EXCEPTIONAL WORK BY MEMBERS OF THE WORKING GROUP, GAIN ALIGNMENT ON THESE PRAWP PRAWBS AND COME TO CONSENSUS ON RECOMMENDS, THE RECOMMENDATIONS WE BELIEVE ARE A VERY IMPORTANT STEP FORWARD, MAKE SIGNIFICANT IMPROVEMENTS, THE METHODS OF COMMUNICATION WILL BE CRITICAL, YOU WANT TO ALWAYS HIGHLIGHT THE IMPORTANCE OF TRANSPARENCY, FAIRNESS, INPUT FROM CENTERS AND THE FINE-TUNING THAT WILL BE REQUIRED, IT HAS TO BE FRAMED WITHIN THE MISSION OF NCI AND THE NATIONAL CANCER PROGRAM, NOT A REACTION TO DIFFICULT BUDGET TIMES OR ANYTHING TO DO WITH POLITICAL PURPOSES. WE HAVE TO EMPHASIZE AND ALWAYS EMPHASIZE TO OUR CONSTITUENTS THE REMARKABLE SUCCESS OF THE CANCER CENTERS' PROGRAM, IT'S OVERALL IMPORTANCE AND IMPACT, AND THAT THESE CHANGES ARE DESIGNED TO ENHANCE WHAT WE SEE AS A NATIONAL TREASURE. SO THAT WAS THE REPORT, AND I GUESS CAN TAKE SOME QUESTIONS. SO THANKS. >> THANK YOU, BILL. BY EXTENSION, THANKS TO YOUR WORKING GROUP. QUESTIONS FOR BILL? I ACTUALLY WANT TO START. WITH RESPECT TO THE NON-RENEWAL Q WHICH YOU BROUGHT UP EARLY BUT DIDN'T REALLY COME BACK TO, I'M JUST CURIOUS WHAT YOUR GROUP WAS THINKING TOWARDS THE END OF YOUR DELIBERATIONS. >> IT'S A STICKY WICK, IF YOU WILL, BECAUSE THERE IS THE -- THERE ARE MANY, MANY ISSUES FOR WHY THE NCI WOULD WANT A CENTER IN A PARTICULAR GEOGRAPHIC LOCATION, AND I THINK THE IDEA THAT IN ARE WAYS TO WORK WITH THOSE CENTERS TO HELP THEM IMPROVE, THERE'S THAT HOPE BUT FOR CHRONICALLY UNDERPERFORMERS WHERE THERE'S NOT ANOTHER IMPORTANT ASPECT TO THEM, THE GROUP DIDN'T FEEL WE HAD THE IMPROMITUR OH TO MAKE SUCH A STRONG RECOMMENDATION BUT AT LEAST BRING IT TO THE ATTENTION OF THE NCAB. >> SO BILL, THANKS. I WAS CAPTIVATED BY ONE OF THE EARLY CONCLUSIONS WHICH WAS TO REWARD THE CANCER CENTERS FOR WHAT THEY'RE GOOD AT AND NOT PENALIZE THEM FOR WHAT THEY'RE NOT GOOD AT. COULD YOU SAY MORE ABOUT WHAT THAT ACTUALLY MEANS IN TERMS OF IMPLEMENTATION? BECAUSE I GOT THE IMPRESSION, THERE'S THE CHECKLIST OF THINGS THAT YOU NEED TO MEET, AND DOES THIS MEAN MODIFYING SOME OF THE GUIDELINES TO QUALIFY AS A CANCER CENTER IN >> I THINK BROADLY, THE WAY I UNDERSTOOD IT AND ACTUALLY THE RECOMMENDATION CAME FROM YOUR CENTER, WHICH IS QUITE INTERESTING, THAT BROADLY SPEAKING, THERE ARE CERTAIN COMPONENTS THAT MAKE UP A COMPREHENSIVE CENTER AND THEY WOULD CHANGE, BUT WITHIN THOSE COMPONENTS, CRAIG'S POINT WHICH WAS VERY WELL TAKEN BY EVERYONE, THE CCSG CAN'T POSSIBLY FUND EVERYTHING. YOU CAN'T POSSIBLY DO EVERYTHING. SO REALLY, THE FOCUS AND THE EMPHASIS IS ON WA YOU'R WHAT YOU'RE DOING IT, HOW WELL YOU'RE DOING IT, AND MOST IMPORTANT, THE IMPACT OF THE SCIENCE THAT'S COMING OUT OF YOUR CENTER. THAT WAS THE THINKING BEHIND THAT. >> DOES THAT RESULT IN AN ACTION ITEM THAT COMES BACK HERE, OR -- >> IT MIGHT. I MEAN, LINDA WILL TAKE THAT -- LINDA'S GROUP WILL TAKE THAT RECOMMENDATION BACK AND SEE HOW PERHAPS THE REVIEWS AND THE GUIDELINES MIGHT BE TWEAKED, BUT WE DIDN'T GO THAT FAR. >> MACK. >> IT'S A NICE OVERVIEW. IT'S A LITTLE UNCLEAR TO ME HOW YOU BALANCE THE NEED TO HAVE EQUITABLE DISTRIBUTION OF CANCER CENTERS AND TO MEET THE NEEDS OF THE VARIOUS DIVERSE POPULATIONS, AND AT THE SAME TIME, WHEN A CENTER IS UNDERPERFORMING, IF YOU ELIMINATE FUNDING FOR THAT CENTER, YOU MAY EXACERBATE THOSE PRE-EXISTING OTHER ISSUES THAT MAKE THOSE SITUATIONS WORSE, SO I'M NOT SURE, YOU KNOW, HOW YOU WOULD METRIC THAT. AND THE CORRELATION COEFFICIENT THAT YOU SHOWED WHEN YOU BROUGHT THE CURVES CLOSER TO THE LINE, THE QUESTION IS, DOES THAT ADVERSELY IMPACT ALL THOSE OTHER CONSIDERATIONS THAT YOU MENTIONED AS ISSUES? >> I THINK THAT'S -- YOU'RE HITTING RIGHT ON THE COMPLEXITY OF THE PROBLEM AND HOW YOU BALANCE A MANDATE TO ENSURE ACCESS TO THE KINDS OF QUALITY RESEARCH AND TRANSLATIONAL RES TO GEOGRAPHIC AREAS, TO SPECIAL POPULATIONS, TO THE UNDERSERVED. THAT'S WHY IT'S SOMETHING THAT SHOULD BE LOOKED AT WITHIN THOSE COMPLEXITIES, I'D ASK LINDA OR HAROLD TO COMMENT HERE, IT'S A COMPLICATED ISSUE. >> CLASSIC ONE, WOULD YOU BE BETTER OFF GIVING YOUR MONEY TO PEOPLE WHO WERE UNDERPERFORMING SO THEY CAN PERFORM BETTER, AND THAT, I THINK HISTORICALLY HAS NOT BEEN THE SOLUTION TO THE PROBLEM. I WOULD RATHER SEE THE MONEY GO TO THE PLACES THAT ARE PERFORMING BEST. BUT IT IS A DILEMMA, AND OBVIOUSLY WE TAKE INTO CONSIDERATION MAKING ALL THOSE DECISIONS WHERE THE CENTER IS LOCATED, WHAT POPULATIONS IT'S SERVING AND WHAT KINDS OF RESEARCH IT DOES, AND I THINK WHAT'S BEEN REALLY GOOD ABOUT THE WAY THIS REPORT HAS BEEN GENERATED IS IT IS GENERIC, IT LEADLEAVES TO US THE FLEXIBILITY TO MAKE ADJUSTMENTS BASED ON OTHER CONSIDERATIONS. TO SUPPLEMENTS, OTHER KIND OF QUALIFICATIONS. I THINK IT'S IMPORTANT THAT THERE WASN'T A DIRECT -- [INAUDIBLE] -- AND ALMOST LABOR OF PREPARING AN APPLICATION FOR A CANCER CENTER. I THINK BEING A CANCER CENTER DIRECTOR MYSELF, I KNOW THAT THE A PAPERWORK EVEN FOR A NON-COMPETITIVE RENEWAL, LET ALONE A COMPETITIVE RENEWAL, IS TREMENDOUSLY TAXING ON THE SYSTEM. THAT'S A SEPARATE PROBLEM, BUT I THINK IT'S ONE WE SHOULD PAY ATTENTION TO ONCE WE GET TO THE POINT OF KNOWING WHAT THE CRITERIA ARE GOING TO BE, I THINK THAT WILL HELP RESHAPE THE APPLICATION PROCESS SES. >> BILL, THEN KEVIN, THEN JUDY. >> THANKS FOR DOING THIS. I KNOW IT'S NOT A VERY THANKFUL POSITION YOU'RE IN. [LAUGHTER] >> I'M NOT GOING TO MAKE IT THAT EASY. I'LL MAKE A STATEMENT -- >> THAT'S THE WRONG BILL. >> SO THE STATEMENT AS I MADE AT THE PRIOR MEETING I WAS AT IS I THINK THE BUDGET FOR THE NCI CANCER CENTERS IS TOO LOW. I UNDERSTAND THAT WE'RE IN A TIGHT BUDGET SITUATION. I DON'T -- DOESN'T MATTER TO ME. WE NEED TO INCREASE FUNDING FOR THE CANCER CENTER PROGRAMS IN GENERAL SO WE'RE NOT SPREADING TINY BITS OF MONEY AROUND TO 68 CANCER CENTERS TO THE POINT WHERE THEY BECOME INEFFECTIVE IN GETTING ANYTHING DONE. SO I THINK MY OWN FEELING, PERSONAL TOUGH DECISIONS WOULD NEED TO BE MADE TO FIND GREATER RESOURCES FOR THE CANCER CENTER PROGRAM IN GENERAL. THE QUESTION I HAD IS ABOUT THE SORT OF EFFORT TO MATCH MERIT AND PAYMENTS, AND IT SEEMS TO ME IT ASSUMES TWO THINGS. ONE THAT MERIT SCORES ARE, IN FACT, LINEAR, THE MERIT PROCESS BY ITSELF ACTUALLY RANKS MERIT IN A LINEAR WAY RATHER THAN IN A NON-LINEAR WAY OR IN A DISCREET WAY, SO AT ONE END OF THE SPECTRUM, LOW IS LOW, IT DOESN'T MATTER HOW MUCH LOWER THAN LOW YOU ARE, THERE'S RANDOM NOISE, AND AT THE UPPER END, THERE'S PROBABLY -- SO ONE QUESTION IS, IS THERE ACTUALLY A LINEAR RELATIONSHIP BETWEEN MEASURED MERIT AND REAL MERIT. THE SECOND IS, FOR A CANCER CENTER OF 1X AND A CANCER CENTER OF 4X BOTH GETTING THE SAME MERIT SCORE, WHAT HAPPENS TO THE SIZE CALCULATION IN THESE MODELS? I DIDN'T SEE THAT ADDRESSED WHEN YOU ACTUALLY HAVE EQUALLY MERITORIOUS PROGRAMS THAT ARE VASTLY DIFFERENT IN SIZE. >> LET ME ADDRESS THE FIRST PART OF YOUR QUESTION. WE'RE STILL WORKING WITH THE MODELING, AS BILL INDICATED. ONE THING, YOU'RE RIGHT, NOT ONLY -- OF COURSE EVERY SITE VISIT TEAM IS GOING TO BE SOMEWHAT DIFFERENT, THEY HAVE A DIFFERENT IMPRESSION OF WHAT A SCORE OF 12 MEANS, THERE ARE LOTS OF FACTORS THAT GO INTO MAKING UP THAT SCORE. BUT IT MAY WELL TURN OUT THAT THE MODELING WILL WORK BETTER USING A PERCENTILE SCORE AS OPPOSED TO AN ABSOLUTE IMPACT FACTOR SCORE. AND THAT'S SOMETHING WE'RE STILL WORKING ON, BUT YOUR QUESTION IS RIGHT ON. THE OTHER QUESTION WE CAN PROBABLY ANSWER BY DOING A LITTLE ARITHMETIC. I CAN'T ANSWER THAT QUESTION OFF THE TOP OF MY HEAD, BUT A LITTLE BIT OF ARIT ME TIB, MAYBE LINDA COULD DO IT ON THE SIDE AND GIVE YOU AN ANSWER TO THAT, BECAUSE THERE IS A WAY TO CALCULATE THAT THAT. >> FOR SIZE AND COMPLEXITY, THAT WOULD PROBABLY TAKE A WORKING GROUP IN ITSELF TO GET IT JUST RIGHT, BUT LINDA CAN PROBABLY TAKE IT OFFLINE AND GIVE YOU SOME SENSE. >> ARBITRARY DECISIONS WERE MADE, YOU CAN'T MAKE THESE NUMBERS PERFECT. THE 15%, THE 30%, THOSE ARE NUMBERS THAT ARE COMPROMISES AND THEY'RE NOT GOING TO BE PERFECT FOR EVERYBODY, BUT THE ISSUE IS NOT TO CREATE A PERFECT WORLD, MAKE A BETTER WORLD. >> ONE OF THE THINGS THAT WAS VERY INTERESTING, ONE OF THE THINGS WE LOOKED AT WAS THE NUMBER OF THINGS THAT ARE SUPPORTED BY A CENTER OF DIFFERENT SIZE, NUMBER OF SHARED RESOURCES, THE NUMBER OF SENIOR LEADERSHIP, ET CETERA, DIFFER GENERALLY SPEAKING THE LARGER THE CENTER, THE MORE OF SHARED SERVICES, SO THAT WAS ONE OF THE CONSIDERATIONS. >> WE HAVE SEVERAL PEOPLE WHO WANT TO CHIME IN. I ALWAYS WANT TO NOTE THAT LINDA WEISS IS HERE, SHE'S TAKING ALL OF THIS IN. YOUR COMMENTS ARE HAVING AN IMPORTANT IMPACT. I THINK IT'S KEVIN, THEN JUDY, THEN FUME. >> FIRST AS SOMEBODY WHO FEELS A LITTLE RESPONSIBLE FOR INSTIGATING THIS, I WANT TO OFFER THANKS TO HAROLD FOR SETTING UP THE WORKING GROUP AND BILL AND LINDA FOR REALLY LEADING IT. THE POINT THAT WAS JUST MADE, THE THING THAT WAS MOST ENCOURAGING TO ME ABOUT THE WHOLE PROCESS WAS THAT THERE WAS A BROAD VARIETY OF CENTERS REPRESENTED AND PEOPLE VERY QUICKLY SAID WE HAVE TO MAKE COMPROMISES HERE, THIS IS NOT A PERFECT FORMULA, THIS IS NOT A PERFECT RECOMMENDATION. CLINICAL CENTERS TEND TO BUNCH IN A VERY NARROW MERIT SCORE RANGE, SO I DON'T THINK THAT THE MIT SCORES ARE A PERFECT REPRESENTATION OF QUALITY, BUT WE GAVE THAT UP, YOU KNOW, PEO ACKNOWLEDGED THAT AND THERE ARE OTHER PARTS OF THE FORMULA THAT BALANCE THAT. I DON'T THINK IT'S PERFECT, BUT I THINK IT WAS VERY ENCOURAGING HOW PEOPLE ARE WILLING TO COME UP WITH COMPROMISES. THE QUESTION I HAVE, AND WE'VE TALKED ABOUT IT A LITTLE BIT IN THE WORKING GROUP BUT I'D BE INTERESTED, BILL AND LINDA OR EVEN HAROLD, THAT ONE OF THE MAJOR COMPLEXITIES THAT I SEE THAT'S STILL UNRESOLVED IS HOW THIS WILL BE IMPLEMENTED. THIS IS A FORMULA THAT IDEALLY WORKS IF IT'S REBUDGETED EVERY YEAR. IT'S DIFFICULT TO MAKE FIVE-YEAR AWARDS AND -- OR PHASE THE CENTER OVER A GRADUAL PERIOD OF TIME AND MEET TH THE INTENT OF THE REVISION, SO I'D BE INTERESTED IN COMMENTS FROM BILL OR FROM LINDA OR POSSIBLY DR. VARMUS ABOUT HOW THIS MAY BE IMPLEMENTED IF IT'S ADOPTED. >> I CAN TELL YOU, KEVIN, FROM DISCUSSIONS THAT WE HAVE AS YOU KNOW, WE LOOK THE EXTREMES, DO IT ALL AT ONCE, AS A CHANGE, AS A MANDATE, PHASE IT IN SLOWLY OR SOMEWHERE IN THE MIDDLE. THE WORKING GROUP DIDN'T COME TO -- THOUGHT THAT WOULD BE UP TO THE CENTER'S BRANCH BECAUSE IT NOT ONLY IS COMPLICATED BUT SENSITIVE AND I ALSO IN OUR REPORT -- IT WAS POINTED OUT THAT THE WAY THESE CHANGES ARE MADE MAY NOT BE ENTIRELY UNDER THE CONTROL OF THE NCI. THERE'S ANOTHER NIH GROUP THAT TAKES A LOOK AT THIS. SO WE LEFT IT -- WE LAID OUT THE PLAYING FIELD, IF YOU WILL, HAROLD, IF YOU WANT TO COMMENT, BUT THAT'S WHERE WE LEFT IT. >> WE DO HAVE JURISDICTION OVER HOW IT'S PHASED IN, BUT I DON'T THINK ANY OF US HAVE A SIMPLE ANSWER TO THE QUESTION, WHAT'S THE BEST WAY TO DO IT. SO I THINK RECOMMENDATION TWO WEIGHS HEAVILY HERE. WE NEED TO TO BRING THE ADMINISTRATORS IN, TALK TO THEM ABOUT THE IMPACT OF SUDDEN VERSUS GRADUAL CHANGE, AND WE'RE OPEN TO SUGGESTIONS TO TRY TO MAKE THESE CHANGES AS PAINLESSLY AS POSSIBLE SO THE PRODUCTIVITY IS NOT AFFECTED. >> EXACTLY. >> SO I CAN HARDLY IMAGINE THE COMPLEXITY OF YOUR TASK, AND I SHOULD JUST ENDORSE WHAT BILL SELLERS SAID FIRST, BUT I WONDER IF IT WOULD BE POSSIBLE TO HAVE MORE SORT OF SIMULATION. WE HAVE ONE FIGURE HERE, BILL, THAT SHOWS THAT THERE WILL BE HUGE ADJUSTMENTS IN BOTH DIRECTIONS FOR LOTS OF CANCER CENTERS, THAT ROUGHLY HALF OF THEM WILL HAVE AN INCREASE, BUT OTHERS WILL HAVE HUGE DECLINES. YOU CAN IMAGINE THAT THE CANCER CENTER DIRECTORS WILL NOT BE PLEASED, AND THAT THE COMMUNITIES WILL HAVE SOME CHAL ECCHALLENGE TO ADJUSTING IN THE MESSAGE, I THINK, IF YOUR CORE GRANT GOES DOWN BY 50%, WHAT DOES THAT SAY ABOUT THE MERIT OF THE WORK, AND SUPPORT OF THE NCI FOR RESEARCH, WHICH IS, AFTER ALL, I MEAN, THAT IS THE MESSAGE AND THE MISSION OF THE CORE GRANT SUPPORT. THAT'S NOT TO DISPROPORTIONATELY PENALIZE OTHER, BUT I THINK YOU'RE GOING TO HAVE TO COME UP WITH SOME VERY SERIOUS WAYS OF DI PLAYING WHAT YOU HAVE ACHIEVED WITH THIS ADJUSTMENT. CERTAINLY THIS GETS TO MORE EQUITY IF THE GOAL IS EQUITY HAVING CENTERS HAVE CLOSER AMOUNTS OF AWARD OF. BUT IF THE GOAL IS SUPPORTING RESEARCH, THEN YOU'RE GOING TO HAVE TO FIND SOME WAY TO DISPLAY THAT THAT IS NOT WHAT'S PENALIZED COMPLETELY IN THIS, AND THAT YOU HAVE A WAY OF ADJUSTING FOR THAT. I THINK IF YOU DON'T, THAT IT'S GOING TO BE VERY HARD TO JUSTIFY ALL THE WORK OF THE CANCER CENTER CORE GRANT APPLICATIONS WHEN THE AMOUNT OF MONEY THAT YOU'RE REALLY TALKING ABOUT IS SHRINKING SO DRAMATICALLY. AND FINDING A WAY TO BE ABLE TO COMPARE THE MEASUREMENT OF MERIT WHEN THIS IS THE CASE. >> AND THAT WAS CLEARLY A VERY HOT TOPIC OF DISCUSSION. THE PERCEPTION THAT IF A FUNDING MODEL CHANGED AND YOU GOT LESS MONEY, EVEN IF YOU DID EXTREMELY WELL ON YOUR IMPACT SCORE, THERE COULD BE A PERCEPTION IN YOUR COMMUNITY THAT YOU'RE NOT DOING WELL. NUMBER TWO IS THAT THE GRANT GETS SMALLER, ESPECIALLY FOR LARGER CENTERS, DOES IT REACH A TIPPING POINT WHERE IT'S NO LONGER SO VALUABLE THAT THE FACULTY DOESN'T GLOM ON TO IT LIKE THEY DO NOW. I'M NOT SURE GLOMMING ON IS THE SCIENTIFIC TERM, BUT YOU KNOW WHAT I MEAN. >> SO I REALLY APPRECIATE THE THOUGHTFULNESS THAT WEPT INTO WENT INTO THE RECOMMENDATION. I WAS JUST WONDERING WHETHER, WITHOUT REALLY FOCUSING ON THE DOLLAR AMOUNT, WHETHER IT WAS POSSIBLE TO PROVIDE TECHNICAL ASSISTANCE OR SOME OF THAT RESOURCES TO CENTERS THAT ACTUALLY SERVE THE PURPOSE OF THE NCI WHERE THEY JUST IN RESOURCE CONSTRAINTS SITUATIONS, SO IF THE MANDATE REALLY WAS TO DISTRIBUTE THE EFFORTS OF THE NCI THROUGH THE EXTRAMURAL PROGRAM, AND BECAUSE ALL POLITICS IS LOCAL AND BECAUSE PEOPLE LIVE IN DIFFERENT GEOGRAPHIC LOCATIONS IN THIS COUNTRY, AND IF THE EFFORT IS REALLY TO TRY TO GET A CANCER CENTER WITHIN TWO HOURS OF PEOPLE WHO ARE IN DIVERSE SETTINGS, THE QUESTION IS, THE EQUITY IS NOT ONLY OH GOING TO BE REFLECTED ON THE AMOUNT OF DOLLARS YOU GIVE TO A CENTER. SO I'M REALLY CONCERNED ABOUT THOSE POOR PERFORMING CENTERS. ONE OF THE ADDITIONS THE NCI COULD DO AS PART OF THIS REVIEW TO THINK ABOUT WHERE RESOURCES WILL BE NEEDED, WE PROVIDE TECHNICAL ASSISTANCE TO ALL THE COUNTRY, WHAT KINDS OF ASSISTANCE COULD THE NCI LEVERAGE TO BRING CENTERS UP, BECAUSE AT THE END OF THE DAY, IF WE'RE FOCUSED ON THE CANCER PATIENT, WHERE THEY LIVE, IT'S REALLY NOT ABOUT THE DOLLARS, IT'S ABOUT WHAT RESOURCES ARE TRANSFORMING CANCER RESEARCH IN THEIR COMMUNITIES. SO JUST A THOUGHT. WHETHER THE GROUP WOULD THINK ABOUT -- >> LINDA, YOU MIGHT WANT TO SAY SOMETHING ABOUT WHAT WE DO IN RESPONSE TO A POOR PERFORMING CENTER. WE DO PROVIDE THAT KIND OF TECHNICAL ASSISTANCE, WHICH IS A GOOD POINT, AND WE ARE PAYING ATTENTION TO DISTRIBUTION CENTERS, AND AS YOU KNOW, THE COASTS ARE FAIRLY DENSE WITH CENTERS, WE'RE VERY HAPPY TO SEE A NEW CENTER IN KANSAS, AND THAT DOES PLAY A -- >> SO LET ME BEGIN BY SAYING -- SO THE TWO-HOUR MANDATE FOR STARTERS, WELL, NOT A MANDATE, RECOMMENDATION WAS IN THE ORIGINAL LEGISLATION THAT ESTABLISHED THIS PROGRAM IN 1971, CLEARLY WE HAVE NOT EXACTLY MET THAT, AND I THINK THE REASON IS -- ONE MORE. I THINK THE REASON IS THAT THERE ARE VERY HIGH STANDARDS FOR ENTERING INTO THE PROGRAM, SO I WANT TO START BY SAYING EVEN THOUGH WE DO FEEL THAT WE HAVE AN IMPORTANT ROLE IN REPRESENTING THE RESEARCH NEEDS OF UNDER SERVED POPULATIONS, WE ALSO HAVE, I THINK, VERY RIGOROUS STANDARDS IN TERMS OF MERIT. AND YOU DO NOT BECOME AN NCI DESIGNATED CANCER CENTER MERELY ON THE BASIS OF THE FACT THAT YOUR CENTER IS SERVING THE UNDERSERVED. WHEN A CANCER CENTER HAS DIFFICULTIES IN REVIEW, TYPICALLY WHAT WE DO IS WORK WITH THEM. THEY ACTUALLY REDUC REDUCED THE AWARDS FAIRLY DRAMATICALLY. WE USUALLY LIMIT THE NUMBER OF YEARS, IT'S A LESSER NUMBER OF YEARS THAN THE FIVE-YEAR AWARD A CENTER TYPICALLY GETS. WE WORK WITH THEM FAIRLY CLOSELY TO MORE FREQUENT PROGRESS REPORTS AND MEETINGS TO TRY TO SEE HOW THEY'RE ADDRESSING THE DEFICIENCIES THAT WERE ADDRESSED IN REVIEW. SOMETIMES THESE ARE FAIRLY TEMPORARY PROBLEMS THAT ARE -- COME ABOUT DUE TO CHANGES IN LEADERSHIP AND THE UNIVERSITY SETTING AND MATRIX CENTERS, THIS CAN HAVE SOME IMPLICATIONS. SOMETIMES THEY'RE LONGER TERM, I THINK THAT THE NCI DESIGNATION IS SUCH A DESIRABLE DESIGNATION. NOT JUST BECAUSE OF THE MONEY THAT COMES WITH IT, BUT BECAUSE IN AND OF ITSELF, IT BRINGS THE ABILITY TO LEVERAGE SOME OTHER RESOURCES. THAT IN ALMOST EVERY CASE, CENTERS WILL, IN FACT, MAKE SIGNIFICANT PROGRESS AND IN THEIR NEXT REVIEW COME BACK TO PAR. THAT'S NOT, YOU KNOW, NECESSARILY ALWAYS THE CASE. SOMETIMES THE CHANGES ARE SIGNIFICANT ENOUGH THAT WE HAVE TO WORK A LITTLE LONGER AND WE CONTINUALLY ASSESS THAT WITH HAROLD AND OTHER NCI LEADERSHIP TO SEE HOW WE WANT TO GO FORWARD WITH THIS CENTER, WHAT ARE THE REMAINING ISSUES, BUT THERE IS A PROCESS, AND WE DO PROVIDE SOME ASSISTANCE FROM THE PROGRAMMATIC POINT OF VIEW. >> THANKS, LINDA. BEYOND THE POOR PERFORMING CENTERS, JUST THE CENTERS AS A WHOLE, CAN BENEFIT FROM THE NCI IN MANY DIFFERENT WAYS BEYOND THE BUDGET THEY GET FROM THE CCSG, WHICH YOU KNOW AS WELL AND THAT CAN ALWAYS BE ENHANCED. BILL, I HAD A QUESTION FOR YOU, RELATED TO THE TENURE. HAROLD MENTIONED EARLIER THE OIGs AND THE PUSHBACK ABOUT GETTING SEVEN-YEAR AWARDS. ONE WAY TO REDUCE THE ADMINISTRATIVE BURDEN IS TO LENGTHEN THE AWARD. AND IT'S FIVE YEARS FOR AGAIN PROBABLY HISTORICAL REASONS. DID THAT EVER COME UP IN DISCUSSION? >> I DIDN'T THINK THAT CAME UP. YOU COULD CERTAINLY REDUCE ADMINISTRATOR BURDEN. >> I COULD SPEAK MAYBE BRIEFLY TO THAT BECAUSE WE DID PREVIOUSLY HAVE A STIPULATION IN THE GUIDELINES THAT THOSE CENTERS SCORING IN THE OUTSTANDING RANGE, WHICH THIS WAS UNDER THE OLD SCORING SYSTEM SO THAT WAS THE TOP RANGE, COULD, IN FACT, HAVE A SIX HAD SIX-YEAR EXTENSION. NIH POLICY AND OTHER FACTORS, I THINK, CAUSED US TO CEASE THAT POLICY AT LEAST TEMPORARILY. WE HAVE NOT REINSTITUTED AS OF YET. ONE OF THE OTHER PROBLEMS WE HAD WAS IT BEGAN TO CREATE REAL HAVOC WITH THE RECEIPT SCHEDULE BECAUSE WE WERE SLIDING CANCER CENTERS FROM ONE RECEIPT YEAR TO ANOTHER, SO IT JUST BECAME COMPLICATED. >> TWO OTHER ISSUES TOO, TYLER, ONE IS HAVING AN OPPORTUNITY EVERY FIVE YEARS TO RE-ADJUST AND US DOING BETTER. THE OTHER POINT IS I'VE FOUND AS CANCER CENTER DIRECTOR THAT THE FIVE YEAR REVIEW -- IT'S THE CENTER -- IS THE CENTER SET UP R I FOUND THAT WHEN I CAME TO SLOANE-KETTERING, I WANTED TO CHANGE THE WAY THE PLACE WAS ORGANIZED, EVERYBODY APPLAUDED THE IDEA, THIS WAS REALLY GOOD, IT GAVE ME A WEAPON TO USE AGAINST THE CONSERVATIVE FORCES WITHIN THE INSTITUTION. >> ONE OTHER COMMENT IF I COULD MAKE, SO I JUST WANTED TO SAY THAT WE CERTAINLY ARE WILLING TO BEGIN TO TAKE FORWARD THE THOUGHT ABOUT FURTHER STREAMLINING THE GRANT APPLICATION. WE'VE DONE SOME OF THAT, I THINK, WITH THE 2012 GUIDELINES. WE ELIMINATED A LOT OF THE SHARED RESOURCE DATA COLLECTION THAT YOU HAD. I THINK THAT WILL BE AN ONGOING PROCESS. I DO, HOWEVER, WANT TO MAKE A PLUG FOR ENSURING THAT WE MAINTAIN THE RIGOR OF REVIEW FOR THESE BECAUSE OTHERWISE YOU ULTIMATELY DILUTE THE POWER OF THE DESIGNATION. WHICH IS WHAT IT'S ALL ABOUT. >> THERE'S NO DOUBT THAT THE RIGOR OF THE REVIEW CAN BE MAINTAINED WITHOUT AS MUCH PAPERWORK THAT GOES INTO THE PROCESS. WE REALLY NEED TO GO INTO THAT -- >> THERE'S NO PAPERWORK NOW, HAROLD. >> FINE. [LAUGHTER] >> JENNIFER. >> I JUST WANT TO THANK BILL AGAIN AND OBVIOUSLY LINDA AND THE TEAM AND THE TASK FORCE FOR GOING THROUGH THIS, BECAUSE IT'S NOT EASY. IT'S LIKE YOU SAID, A VERY CONTENTIOUS TOPIC. I WANT TO SECOND WHAT BILL HAS SAID AND JUDY ALLUDED TO, WHICH IS THE ISSUE OF THE OVERALL BUDGET. WHEN I LOOK AT SLIDE 5, AND THE DESCRIPTION OF WHAT THE CANCER CENTER PROGRAM IS, POWERFUL WORDS IN THERE. ENVY OF THE WORLD, AND IT'S WHAT, 3% OF THE BUDGET. 3, 3.5, 5%? ABOUT 160 MILLION? SO THAT -- >> [INAUDIBLE] >> BUT THAT PROBABLY NEEDS, LIKE BILL IS SAYING, TO BE LOOKED AT AGAIN, AND ESPECIALLY RELATIVE TO JUDY'S COMMENTS. >> I RESONATE WITH THIS, AND I NEED TO MAKE THE CASE AGAIN, I THINK THE QUESTIONS THAT THE NCAB MIGHT WANT TO THINK ABOUT AND TAKE UP AT THE NEXT MEETING ASK WHETHER YOU WANT TO ENDORSE THE IDEA OF AN INCREASE. ANY INCREASE IN THE CANCER CENTER BUDGET COMES OUT OF OTHER BUDGETS. TO MAKE A SIGNIFICANT CHANGE WOULD BE PRETTY EXPENSIVE. I'M ALSO ACUTELY AWARE OF THE FACT THAT OTHER INSTITUTIONS OF THE NIH HAVE CENTERS AND SOME OF THEM ARE A LOT MORE COSTLY THAN OURS. THE -- I WON'T MENTION NAMES, BUT EVERYONE KNOWS WHAT SOME OF THEM ARE. AND I THINK WE GET AN ENORMOUS BANG FOR THE BUCK. BUT I THINK BEFORE JUST SAYING THESE ARE THE PRIDE OF THE WORLD AND -- OR THE ENVY OF THE WORLD AND THE PRIDE OF THE U.S., AND WE NEED MORE MONEY FOR THEM, IT WOULD BE VERY USEFUL TO THINK ABOUT WHAT THE CCSG MONEY GOES TO. AFTER ALL, THERE ARE MANY OTHER WAYS IN WHICH WE SUPPORT CANCER RESEARCH AT THESE INSTITUTION, NOT THE LEAST OF WHICH IS GRANTS, PO1s A AND EVERYTHING ELSE, AND I THINK IT WOULD BE VERY USEFUL TO SAY WHAT WOULD HAPPEN IF WE INCREASED THE CANCER CENTER BUDGETS OVERALL BY 1%, 5%, 50%, 100%, AND DOES THAT MAKE SENSE, AND IT'S HARD FOR YOU TO GAUGE WHAT THE LIKELY IMPACT IS BECAUSE IT WOULD BE UP TO US TO DECIDE IF WE WENT ALONG WITH SOME RECOMMENDATION FROM THE NCAB ABOUT THE OVERALL CENTER'S BUDGET, WHERE WOULD THE REDUCTIONS BE TAKEN. THAT'S NOT AN EASY QUESTION THESE DAYS. >> I WANT TO APPLAUD LINDA AND THE TEAM WHO'VE PUT KIND OF THE SUPPLEMENT METHOD IN, HOW THE GLOBAL HEALTH SUPPLEMENTS HAVE COME IN AND HOW, JIM, SOME OF THE PDX SUPPLEMENTS, BECAUSE I THINK -- AND THAT'S PART OF THIS RENOVATION. IT ENABLES REALLY RAPID MOBILIZATION OF WORKFORCE. I LOOK AT BARBARA'S PHENOMENAL PRESENTATION, AND HER DESIRE TO MOVE THIS OUT, AND NOW YOU HAVE CANCER CENTERS IN COMMUNITIES WITH SUPPLEMENTS COULD REALLY HELP CHANGE THE STATISTICS IN MANY OF THOSE COUNTIES. THAT, TO ME, IS A FABULOUS MECHANISM OF THE CANCER CENTER. IT'S PIVOTAL. YOU CAN PIVOT ON VARIOUS NEEDS. >> THE GREAT THING ABOUT THE SUPPLEMENTS IS IT DOESN'T GO INTO THE BASE. >> CORRECT. >> SO I'M A HUGE SUPPORTER OF THEM. THAT'S A FAIR A MONEY, AND ACTUALLY -- I ALSO POINT OUT WE CAN USE THIS MECHANISM NOT JUST FOR THE NCI DESIGNATED CANCER CENTERS BUT FOR OTHER NCI SUPPORTED INSTITUTIONS TO GET MONEY, FOR EXAMPLE, FOR -- IN OUR OTHER N CORE WEB OF CENTERS, MANY DO CLINICAL TRIALS, BUT THERE ARE MANY MINORITY POPULATIONS THAT ARE ADJACENT TO THOSE CENTERS AND WE CAN MAKE BETTER USE OF THOSE CENTERS, I THINK, PORE SOME OF THE THINGS THAT HAVE COME UP HERE IN DISCUSSION. SO TO BRING THIS DISCUSSION TO A CLOSE, IT WAS A GOOD AND HEALTHY DISCUSSION, THANKS AGAIN TO BILL AND TO HIS GROUP, TO LINDA, TO THE NCAB FOR THEIR PARTICIPATION TODAY. THIS IS NOT A FORMAL REPORT AS YOU HER, SO WE'RE NOT ASKING FOR APPROVAL. OR ACCEPTANCE OF THE REPORT. THERE WILL BE A MORE FORMAL REPORT IN THE FUTURE, SO WE'LL BE HEARING ABOUT IT AGAIN IN ORDER TO ACCEPT AND APPROVE, BUT THIS WAS A GOOD DISCUSSION, AND I THINK JUST FOLLOWING UP ON WHAT HAROLD FINISHED WITH, THERE SEEMS TO BE A SENTIMENT AROUND THE TABLE THAT THIS ISSUE OF THE SIZE OF THE NATIONAL CANCER CENTER'S PROGRAM IS WORTHY OF CONSIDERATION. BEYOND WHAT WE JUST HEARD. AND IT HAS IMPLICATIONS FOR THE BUDGET AS A WHOLE. IT RELATES TO BILL GOODWIN'S WORKING GROUP OR SUBCOMMITTEE ON THE BUDGET AND STRATEGY, WE DISCUSSED IT A BIT LAST NIGHT. SO I THINK WE PROBABLY WILL TAKE THAT UP IN SOME FORM. AND RECOGNIZE THAT IT'S NOT GOING TO BE A SIMPLE TASK OF JUST DOUBLING ITS BUDGET BECAUSE IT'S GOING TO HAVE THESE OTHER IMPLICATIONS. ALL OF NOT MORE THAN 151 SPECIAL EXPERTS OR CONSULTANTS WHO HAVE SCIENTIFIC PROFESSIONAL QUALIFICATIONS TO ASSIST IN ACCOMPLISHING THE MISSION OF THE INSTITUTE. AND DON'T ASK ME WHERE THE NUMBERS COME FROM, BILL ASKS ME THAT EVERY YEAR, I'VE TRIED TO FIND OUT AND NO ONE HAS AN ANSWER. DELEGATION B, YOU DELEGATE TO THE NCI DIRECTOR THE AUTHORITY TO APPOINT ONE OR MORE ADVISORY COMMITTEES COMPOSED OF SUCH PRIVATE CITIZENS AND OFFICIALS OF FEDERAL, STATE AND LOCAL GOVERNMENTS TO ADVICE HIM WITH RESPECT TO HIS FUNCTIONS. WE HAVE TO HAVE CONCURRENCE OF THE NCAB TO MAKE ANY AWARDS OF GRANTS, BUT THERE ARE EXCEPTIONS WHERE WE DON'T NEED YOUR CONCURRENCE. SPECIFICALLY WE -- GRANTS AND FELLOWSHIPS AND OTHER NON-RESEARCH GRANT APPLICATIONS. THOSE ARE NOT SUBJECT TO NCAB APPROVAL, AND MAY BE AWARDED WITHOUT PRESENTATION TO THE NCAB FOR CONCURRENCE. WITH THE EXCEPTION OF THE RUTH KIRSTEN NATIONAL RESEARCH SERVICE AWARD. APPLICATIONS THAT ARE OVER THE 50TH PERCENTILE, AS YOU KNOW, WE DO NOT HAVE SUMMARY STATEMENTS SO YOU DO MOT HAVE TO LOOK AT THOSE. THOSE APPLICATIONS THAT ARE ASSIGNED RAW SCORES, AND I HAVE TO MAKE A CORRECTION IN THIS, BUT YOU CAN STILL APPROVE IT LATER. THOSE APPLICATIONS WITH RAW SCORES OF 40 FOR ALL MECHANISMS WITH THE EXCEPTION OF R41s, 42s, 43s AND 44s, MUST -- WILL NOT COME TO THE BOARD UNLESS A BOARD MEMBER OR A STAFF PERSON HAS A STAFF -- A SPECIAL REQUEST TO CONSID THOSE GRANTS FOR FUNDING. THAT IS, WITH THE EXCEPTION OF THE SBIRs AND SGRs, ALL OF THOSE WILL COME TO THE BOARD. AND I APOLOGIZE FOR MY VOICE BUT THERE'S NOTHING I CAN DO ABOUT IT. FOR RO1 AND RO21 APPLICATIONS, US AS YOU KNOW, WE HAVE EARLY CONCURRENCE FOR THOSE THAT ARE WITHIN, AND I WILL NOT USE THE WORD THAT HAROLD DOESN'T LIKE, BUT WITHIN OUR ZONE OF CONSIDERATION. THOSE DO NOT HAVE TO COME TO THE BOARD, BUT THEY ARE INCLUDED IN THE ENBLOCK, AND IF ANY OF YOU WOULD LIKE TO SEE EXACTLY WHAT THOSE GRANTS ARE, YOU CAN GO TO THE ELECTRONIC COUNCIL BOOK TO SEE THEM. ADDITIONALLY, WE HAVE THREE NUMBERS -- FOUR MEMBERS FROM THE NCAB WHO ACTUALLY LOOK AT THOSE CLAIMS, A AND THOSE MEMBERS INCLUDE THE CHAIR AND THREE OTHER MEMBERS, AND THE CHAIR OF THE BOARD IDENTIFIES OR SELECTS THOSE MEMBERS. IN TERMS OF ADMINISTRATIVE ADJUSTMENTS, YOU DELEGATE TO THE NCI DIRECTOR PERMISSION TO -- TO NEGOTIATE APPROPRIATES, OTHER TERMS AND CONDITIONS OF GRANT AND COOPERATIVE AGREEMENT AWARDS RECOMMENDED BY THE BOARD. ADMINISTRATOR REQUESTS FOR INCREASES IN DIRECT COSTS WHICH ARE THE RESULT OF MARKED EXPANSION OR SIGNIFICANT CHANGE IN SCIENTIFIC CONTENT OF A PROGRAM AFTER FORMAL REVIEW WILL BE REFERRED TO THE BOARD FOR ADVICE AND RECOMMENDATION. ACTIONS NOT REQUIRING BOARD REVIEW OR ADVICE INCLUDE CHANGE OF INSTITUTION, CHANGE OF PRINCIPAL INVESTIGATOR, PHASEOUT OF INTERIM SUPPORT, ADDITIONAL SUPPORT EITHER TO MEET THE INCREASED COST OF MAINTAINING THE LEVEL OF RESEARCH PREVIOUSLY RECOMMENDED OR TO ACCOMMODATE ACTIVITIES JUDGED BY STAFF TO BE WITHIN THE SCOPE OF THE PREVIOUS PEER REVIEWED RESEAR IN ADDITION, STAFF MAY RESTORE REQUESTED TIME AND SUPPORT WHICH WERE DELETED BY THE INITIAL REVIEW GROUP WHEN THE -- APPEAL LETTER, THE RESTORATION IS IN THE BEST INTEREST OF THE INSTITUTE AND THE PROJECT IS OF HIGH NCI PROGRAMMATIC RELEVANCE. AND FINALLY, SPECIAL COUNCIL REVIEW, AS YOU KNOW, TO CONTINUE RESPONSIBLE STEWARDSHIP OF PUBLIC FUNDS, WE MUST BRING THOSE GRANTS WHERE A P.I. HAS A PENDING APPLICATION, BUT HIS CURRENT SUPPORT IS 1 MILLION OR BETTER. CIRCUMSTANCES REQUIRE BASED ON PROGRAMMATIC CONSIDERATIONS, THE NCI DIRECTOR IN CONSULTATION WITH THE NCAB CHAIR MAY TAKE EXCEPTIONS TO THESE GUIDELINES. IF THERE IS ANYTHING THAT I'VE SAID THAT YOU DO NOT AGREE WITH WITH? >> SO I NEED A MOTION TO ACCEPT THE ANNUAL DELEGATION. ANY FURTHER DISCUSSION? ALL THOSE IN FAVOR? ANY OPPOSED? MOTION CARRIES. ALL RIGHT. WONDERFUL. SO WE ARE NOW GOING TO TAKE A SHORT BREAK. THE BREAK IS SCHEDULED TO BE 10 MINUTES IN LENGTH. AND IT WILL BE 10 MINUTES IN LENGTH. SO WE WILL RESUME AT 10:35. WE'LL BE WELL AHEAD OF SCHEDULE. >> OKAY. LET'S SETTLE DOWN, SETTLE IN. WE'RE GOING TO GET STARTED WITH OUR SERIES OF DISCUSSIONS RELATED TO TOBACCO. BEFORE WE GET STARTED, I WANTED TO MAKE ONE ANNOUNCEMENT WHICH IS RELEVANT TO AT LEAST TWO OF YOU. >> MORE THAN TWO. >> DIRECTOR JACKS: SIX. SHOCKING. LISTEN UP. SIX OF YOU ARE SCHEDULED TO ROTATE OFF THIS AUGUST BOARD SHORTLY. YOU'RE PROBABLY LOOKING FORWARD TO THAT. SADLY, YOUR REPLACEMENTS HAVE NOT BEEN NAMED, AND AS SUCH, YOUR SERVICE IS STILL NEEDED. AND THEREFORE, THE JUNE AND SEPTEMBER MEETINGS SHOULD STILL BE ON YOUR CALENDARS. CERTAINLY JUNE, YOU WERE PROBABLY SCHEDULED TO COME TO JUNE ANYWAY, BUT WHAT WE'RE TALKING ABOUT NOW IS AN EXTENSION BEYOND JUNE INTO SEPTEMBER. SO KI HONG, WHO HAD LIKE A FISHING TRIP PLANNED FOR SEPTEMBER -- SO I APOLOGIZE FOR THAT. IF YOU HAVE ANY PROBLEM FOR THAT, BLAME PAULETTE, I HAD NOTHING TO DO WITH IT. SPH. [LAUGHTER] >> DIRECTOR JACKS: OKAY. WITH THAT SAID -- OH, HAROLD HAS A COMMENT TO MAKE. >> I AGREE WITH TYLER, THIS IDEA OF DOING SOMETHING ABOUT TOBACCO WAS A RECOMMENDATION FROM NCAB LAST TIME, IT'S A GOOD SIGN THAT WE ARE LISTENING TO WHAT YOU SAY. BUT THERE WERE OTHER IMPORTANT IMPERATIVES FROM MY POINT OF VIEW. ONE WAS TO GIVE FOLKS HERE A CHANCE TO THINK ABOUT THE UPDATED SURGEON GENERAL'S REPORT THAT IS THE MAY YOUR REPORT THAT WAS PUT TOGETHER BY THE DEPARTMENT IN HONOR OF THE 50TH ANNIVERSARY. SECOND, WE WERE ALL VERY CONSCIOUS OF THE INCREASING USE OF E-CIGARETTES, TIME FOR US TO SPEND SOME TIME TALKING ABOUT WHAT THAT MEANS. I AM VERY GRATEFUL TO BOB KROW, WHO IS NOT HERE TODAY, ONE OF THE GREAT DIVISION DIRECTORS THAT HELPED ME IN THE PLANNING O THIS AND RECOMMENDED THAT MICHELLE BLOCK HELP WITH THE CHAIRING OF THE SESSION AND THE INVITATION OF SPEAKERS. I'M VERY GRATEFUL TO THE MANY PEOPLE WHO HAVE TRAVELED A LONG WAY TO SPEND 20 MINUTES ON THE TOPIC TO TRY TO PORTRAY VARIOUS ASPECTS OF WHAT REPRESENTS ON THE ONE HAND ONE OF THE GREAT TRIUMPHS IN CANCER RESEARCH, CONTROL OF TOBACCO USE, BUT ON THE OTHER HAND, REMAINING PROBLEM OF ENORMOUS COMPLEXITY. MICHELLE. THANK YOU VERY MUCH. >> THANK YOU, DR. VARMUS, AND THANK YOU TO THE BOARD AND VISITORS TO ALLOWING US TO BE HERE TODAY. I'M GOING TO TRY TO FILL BOB'S VERY LARGE SHOES AS BEST I CAN. MY NAME IS MICHELLE BLOCH, I AM THE CHIEF OF NCI'S TOBACCO CONTROL RESEARCH BRANCH. ACTUALLY BEFORE I BEGIN MY TALK, I'M GOING TO JUST DO VERY BRIEF INTRODUCTIONS FOR OUR OTHER SPEAKERS WHO WILL BE WITH US THIS MORNING. OUR NEXT SPEAKER IS WELL-KNOWN TO YOU, DR. JOHN SAMET, A MEMBER OF YOUR BOARD. HE IS PROFESSOR AN CHAIR OF THE DEPARTMENT OF MEDICINE AT USC. HE'S ALSO CHAIR OF THE FDA'S TOBACCO PRODUCT SCIENTIFIC ADVISORY COMMITTEE. HE SERVED AS AN EXPERT WITNESS IN THE GOVERNMENT'S RACKETEERING TRIAL. HE IS THE SENIOR SCIENTIFIC EDITOR OF NOT ONE OR TWO BUT THREE SURGEON GENERAL'S REPORTS I THE ONE THAT WE'LL HEAR ABOUT TODAY. DR. ROY HERBS IS A NATIONALLY RECOGNIZED EXPERT FOR HIS WORK ON LUNG CANCER TREATMENT AND RESEARCH AND ALSO CHAIRS THE ACR'S TOBACCO AND CANCER SUBCOMMITTEE, AND HE IS A LEADING AND HIGHLY EFFECTIVE VOICE FOR ADDRESSING TOBACCO USE IN THE CANCER SETTING. THANK YOU FOR BEING WITH US, ROY. OUR THIRD SPEAKER FOR THIS MORNING IS DR. MICHAEL FIORE, WHO IS PROFESSOR OF MEDICINE AT THE UNIVERSITY OF WISCONSIN, AND THE FOUNDER AND DIRECTOR OF THE UNIVERSITY CENTER FOR TOBACCO RESEARCH AND INTERVENTION, ONE OF THE LEADING RESEARCH CENTERS FOR TOBACCO IN THE COUNTRY. HE IS A LEADING NATIONAL EXPERT ON CESSATION. HE CHAIRED ALL THE VARIOUS -- ALL THE PANELS WHICH PRODUCE THE THREE CLINICAL PRACTICE GUIDELINES ON TREATING TOBACCO USE AND DEPENDENCE. HE WAS ALSO AN EXPERT WITNESS IN THE TOBACCO FEDERAL RACKETEERING TRIAL AND A LONG TIME NCI GRANTEE. SO WITH THAT, I'M GOING TO OPEN WITH AN OVERVIEW OF NCI'S RESEARCH AND PARTNERSHIP IN TOBACCO CONTROL. I'M ALSO GOING TO PROVIDE A LITTLE BIT OF CONTEXT PORE SOME OF THE TALKS THAT ARE TO COME. THE FIRST POINT I WANT TO MAKE, AND I THINK YOU'LL HEAR THIS FROM A NUMBER OF SPEAKERS, IS TOBACCO CONTROL IS VERY MUCH A SORT OF GLASS HALF FULL, GLASS HALF EMPTY STORY, IF YOU WILL. THE FIRST FEW SLIDES OF MY TALK DEMONSTRATE THE TREMENDOUS SUCCESSES THAT WE'VE ACHIEVED. FIRST TO SOME DEGREE WITH NCI SUPPORT, WE HAVE PRODUCED MOUNTAINS OF EVIDENCE OVER A LONG PERIOD LINKING TOBACCO USE TO DISEASE. AND THIS HAS BEEN ONE OF THE MANY FACTORS CHANGING SOCIAL NORMS ABOUT TOBACCO USE. WE'VE GONE FROM A TIME WHEN PHYSICIANS AND NURSES WERE DEPICTED IN TOBACCO ADVERTISEMENTS ALONG WITH MANY CELEBRITIES, TO ONE WHERE TOBACCO USE IS BANNED IN OPT HOSPITALS, CLINICS AND REALLY ALMOST ALL PUBLIC PLACES AND WORKPLACES. MANY OF YOU MAY HAVE SEEN THE ANNOUNCEMENT JUST A FEW WEEKS AGO THAT THE MAJOR PHARMACY CHAIN, CVS, VOLUNTARILY DECIDED TO STOP SELLING ALL TOBACCO PRODUCTS EFFECTIVE IN JUST A FEW MONTHS. A VERY EXCITING DEVELOPMENT. PERHAPS THE MOST IMPORTANT PART OF OUR SUCCESS HAS BEEN DRAMATIC DECLINES IN SMOKING PREVALENCE, FROM THE MID 40s IN THE 1960s TO LESS THAN 20% TODAY. AND THIS DECLINE HAS BEEN ASSOCIATED WITH TREMENDOUS DECREASES IN TOBACCO-CAUSED DISEASE. I SKIPPED THE OTHER SLIDE JUST TO MOVE DIRECTLY TO THE LARGEST ASSESSMENT DONE TO DATE WITH SUPPORT FROM NCI'S CANCER INTERVENTION SURVEILLANCE MODELING NETWORK, A GROUP OF INVESTIGATORS MODELED 50 YEARS OF IMPACT OF TOBACCO CONTROL ON TO BETOTOBACCO-RELATED DISEASE ALL CAUSE MORTALITY, # MILLION PREMATURE DEATHS OVER THAT PERIOD WERE AVOIDED AND EXTENDED MEAN LIFESPAN BY NEARLY 20 YEARS. THAT IS TRULY A REMARKABLE SUCCESS. BUT THE LATTER HALF OF THIS SLIDE BEGINS TO TELL THE OTHER HALF OF THE STORY, WHAT REMAINS TO BE ACCOMPLISHED. DURING THAT SAME PERIOD, MORE THAN 17 MILLION DEATHS OCCURRED FROM TOBACCO USE DISEASE. AS THEY ACCURATELY STATE, NO OTHER BEHAVIOR COMES CLOSE TO CONTRIBUTING SO HEAVILY TO THE NATION'S MORTALITY BURDEN. THIS SLIDE, WHICH DEPICTS PREVALENCE AMONG VARIOUS DEMOGRAPHIC GROUPS HELPS EXPLAIN WHY IT'S BEEN SO MIXED. OVERALL PREVALENCE IS ABOUT 20%, JUST A LITTLE UNDER, BUT PREVALENCE AMONG THE MOST EDUCATED AMERICANS, THOSE WITH A GRADUATE DIPLOMA AND THOSE WITH AN UNDERGRADUATE DEGREE IS FAR LOWER, AND, IN FACT, HAS BEEN DECLINING STEADILY FOR YEARS, AND THIS KIND OF MAKES IT EASY TO SEE WHY SOME GROUPS IN THE POPULATION, ESPECIALLY DECISION-MAKERS, COULD THINK THAT THE PROBLEM OF TOBACCO USE HAS, IN FACT, BEEN SOLVED, BECAUSE FOR THESE FOLKS, IT REALLY HAS BEEN SOLVED. BUT FOR FOLKS WITH LESS EDUCATION, PARTICULARLY THOSE WHO LIVE BELOW POVERTY AND AS WE'LL HEAR LATER, PEOPLE WITH MENTAL HEALTH CONDITIONS AND OTHER TYPES OF SUBSTANCE ABUSE SMOKE AT MUCH HIGHER RATES. WE ALSO HAVE VERY LARGE DISPARITIES BASED ON STATES BY GEOGRAPHY WITH THE VERY DARK GREEN AND SOMEWHAT LIGHTER GREEN REPRESENTING STATES WITH VERY HIGH PREVALENCE, AND WHETHER DUE TO GEOGRAPHY OR DEMOGRAPHICS, THESE SHOW UP IN DIFFERENCES IN TOBACCO-RELATED MORTALITY, AND HERE JUST AN EXAMPLE IS SPHERE DATA SHOWING US LUNG CANCER RATES BY STATE, AND WE SEE A RATHER SIMILAR PATTERN TO WHERE TOBACCO USE IS HIGHEST. BEFORE I LEAVE THIS SECTION OF THE TALK, I DO WANT TO SAY JUST A WORD ABOUT GLOBAL TOBACCO BURDEN. BOTH IN THE UNITED STATES AND MOST -- AND IN MOST HIGH INCOME COUNTRIES, TOBACCO USE HAS EITHER BEEN STEADY OR SLOWLY DECREASING, AND THIS HAS MEANT THAT THE TOBACCO COMPANIES HAVE BEEN LOOKING FOR OTHER MARKETS AND THEY HAVE FOUND THEM IN LOW AND MIDDLE INCOME COUNTRIES, WHERE MORTALITY IS GROWING AND THE BURDEN OF TOBACCO USE IS SHIFTING, AND YOU'LL HEAR MORE ABOUT THIS FROM BOTH DR. -- AND DR. TRIMBLE LATER TODAY. SO NOW I WANT TO JUST BRIEFLY OVERVIEW THE NCI TOBACCO RESEARCH PORTFOLIO. AND HIGHLIGHT A FEW GRANTS FOR YOU TO GIVE YOU A TASTE OF THE WORK WE SUPPORT. FIRST THE NUMBERS. THE TOBACCO CONTROL PORTFOLIO IN NCI IN FISCAL 2013, 111 GRANTS, A LITTLE UNDER $60 MILLION. 50% CESSATION, GLOBAL TOBACCO RESEARCH, THE REMAINING PORTFOLIO IS DISTRIBUTED BETWEEN A BROAD SWRA RIGH VARIETY OF CATEGORIES. BUT IN ADDITION, IN THE LAST FEW YEARS, WE'VE BEEN FORTUNATE TO ACQUIRE AN ENTOIRLY NEW PORTFOLIO BASED ON TOBACCO REGULATORY SCIENCE FUNDED UNDER THE NIH-FDA PARTNERSHIP, BUT WHAT I WANT YOU TO SEE HERE IS THAT IN FISCAL '13, THIS PORTFOLIO NOW CONSISTS OF 33 GRANTS CONSISTING A LITTLE LESS THAN $40 MILLION. AND A FEW THINGS TO NOTE ABOUT THIS WORK. WHILE IT IS PRIMARILY AIMED AT INFORMING FDA REGULATION, TH IT WILL HAVE RESONANCE FAR OUTSIDE FDA AND FROM A VERY PRACTICAL STANDPOINT, IT'S ONE OF THE FEW NEW SOURCES OF REVENUE FOR TOBACCO RESEARCH. SO IT'S GENERATED TREMENDOUS EXCITEMENT. NOW I'LL WALK US THROUGH SOME OF THE TOBACCO CONTROL FUNDING INITIATIVES. WE HAVE ONE ON LOW INCOME -- INCREASING CESSATION AMONG LOW INCOME POPULATIONS, OBVIOUSLY VERY IMPORTANT GIVEN THE DEMOGRAPHICS OF TOBACCO USE. WE HAVE AN INITIATIVE FOCUSED ON SMOKELESS TOBACCO WHICH REMINDS ME TO NOTE THAT CIGARETTES ARE NOT THE ONLY TOBACCO PRODUCT THAT IS USED IN THE U.S., SO WE NEED TO UNDERSTAND THE USE PATTERNS OF OTHER PRODUCT. FINALLY, THE INTERNATIONAL TOBACCO AND HEALTH RESEARCH AND RESEARCH CAPACITY BUILDING ANNOUNCEMENT WHICH IS LED BY THE FOGARTY INTERNATIONAL CENTER AND REPRESENTS THE PRIMARY SOURCE OF RESEARCH FUNDING IN LOW AND MIDDLE INCOME COUNTRIES, NOT JUST FOR THE NIH, BUT REALLY AT A GLOBAL LEVEL, A VERY IMPORTANT PROGRAM THAT YOU'LL HEAR MORE ABOUT FROM DR. TRIMBLE LATER TODAY. WE ALSO SUPPORT AN INITIATIVE FOCUSED ON STATE AND COMMUNITY TOBACCO CONTROL POLICY AND MEDIA RESEARCH. WHICH STU IT DIS DIVERSE TOPIC, AND I NOW WANT TO TAKE A MOMENT JUST TO FOCUS A LITTLE BIT ON THIS FINAL GRANT HERE, NON-SMOKERS IN TOBACCO CONTROL NORMS, POPULA SURVEYS AND INTERVENTION STUDIES. THIS IS A GRANT AT UCSD, AND I THINK IT'S ONE OF THE MOST INNOVATIVE IN THE PORTFOLIO BECAUSE IT LOOKS AT THE ROLE THAT NON-SMOKERS CAN PLAY IN INCREASING BOTH POPULATION LEVEL AND INDIVIDUAL LEVEL CESSATION. SO LET'S JUST THINK ABOUT THAT FOR A MOMENT, WHY WOULD NON-SMOKERS BE IMPORTANT. NON-SMOKERS ARE THE KEY TO SMOKING CESSATION BECAUSE AT THE POPULATION LEVEL, THEY'RE THE MAJORITY OF THE ELECTORATE IN STATES AND COMMUNITIES. SO THEIR SUPPORT IS NEEDED FOR MEASURES LIKE CLEAN INDOOR AIR ORDINANCES, TAXES, PROGRAMS FOR CESSATION. THEIR SUPPORT MOTIVATES ELECTED OFFICIALS TO DO THINGS THAT WILL INCREASE POPULATION LEVEL CESSATION. AND IN ADDITION, IN THE HOME, IN THE FEAL AND TH FAMILY AND COMMUNITY SETTING, NON-SMOKERS CAN BE VERY MOTIVATING TO THOSE AROUND THEM FOR SMOKERS TO QUIT. SO THIS GRANT LOOKS AT BOTH POPULATION SURVEYS AND ALSO MEDIA INTERVENTION BOTH TO STUDY AND SEE WHETHER WE CAN HARNESS ADDITIONAL ENERGY FROM NON-SMOKERS OH BOOST SMOKING CESSATION, A VERY EXCITING AND NOVEL APPROACH. BECAUSE OF THE BURDEN OF TOBACCO USE IN PARTICULAR POPULATIONS, A GOOD PART OF OUR PORTFOLIO IS FOCUSED ON PARTICULAR VULNERABLE POPULATIONS, I WON'T SAY MORE AB THAT HERE. WE ALSO HAVE GRANTS FOCUSED ON DIFFERENT TOBACCO PRODUCTS. YOU'LL HEAR LATER THIS AFTERNOON FROM DR. PAMELA CLARK AT THE UNIVERSITY OF M.D. ON E-CIGARETTES BUT SHE ALSO HAS A GRANT FROM US ON WATERPIPE SMOKING. WATERPIPES ARE COMMONLY USED IN THE MIDDLE EAST AND ASIA BUT THEY ARE NOW SPREADING AROUND T WORLD BECAUSE OF COURSE WE LIVE IN A GLOBALIZED ENVIRONMENT, AND THOSE OF YOU WHO WORK ON COLLEGE CAMPUSES WOULD KNOW THAT WATERPIPE SMOKING IS ACTUALLY QUITE COMMON AMONG UNIVERSITY STUDENTS. WE HAVE VERY FEW TOOLS AVAILABLE TO STUDY IT AND THAT IS THE FOCUS OF THIS GRANT. I ALSO WANT TO HIGHLIGHT THE WORK -- MANY YEARS FOCUSED ON THE INFLUENCE OF "MOVIE SMOKING," DEPICTS OR PORTRAYALS OF SMOKING IN THE MOVIES AND HOW THAT IMPACTS USE, TOBACCO USE, BOTH INITIATION, MAINTENANCE, AND SO FORTH. THESE FOLKS HAVE BEEN WORKING FOR MANY YEARS, THEY'VE BEEN HIGHLY PRODUCTIVE. THEY BEGAN BY DEVELOPING METHODS TO QUANTIFY EXPOSURE AND LINK IT TO YOUTH INITIATION AND CONTINUATION OF TOBACCO USE. THESE METHODS HAVE NOW BEEN WIDELY ADOPTED BY RESEARCHERS AROUND THE WORLD. THEY AND COLLEAGUES HAVE PRODUCED A LARGE BODY OF EVIDENCE THAT IS NOW FELT TO BE A CAUSAL LINK BETWEEN EXPOSURE TO SMOKING IN THE MOVIES AND USE SMOKING INITIATION. THEY NOW WANT TO EXTEND THIS RESEARCH METHODS TO OTHER TYPES OF CANCER RISK BEHAVIORS, ALCOHOL, FAST FOOD, RISKY SEXUAL BEHAVIORS, AND THEY ALSO BELIEVE IT CAN HELP THEM STUDY OTHER FORMS OF MARKETING TO WHICH YOUTH ARE EXPOSED. THE WORK OF THIS GROUP WAS HIGHLIGHTED IN NCI MONOGRAPH 19, WHICH WAS PUBLISHED IN 2008. THAT VOLUME IS TITLED "THE ROLE OF THE MEDIA IN PROMOTING AND REDUCING TOBACCO USE." THE DUAL POTENTIAL ROLE FOR MEDIA. AND WE MAY FOR THE FIRST TIME IN A GOVERNMENT BODY MADE A CAUSAL STATEMENT LINKING MOVIE SMOKING TO YOUTH INITIATION. THAT'S GENERATED TREMENDOUS POLICY ATTENTION FROM THE MOVIE INDUSTRY, FROM THE ATTORNEYS GENERAL, FROM MEMBERS OF CONGRESS AND SO FORTH. AND THIS IS AN OPPORTUNITY TO MEET A -- FOR ME TO HIGHLIGHT TO YOU ON OUR NCI TOBACCO CONTROL MONOGRAPH SERIES, WHICH IS FOCUSED ON SYNTHESIZING AND DISSEMINATING TO A BROAD AUDIENCE THE WORK THAT WE SUPPORT. I HAVE TWO SLIDES BEFORE I CLOSE THIS PART OF THE TALK. I WANTED TO GIVE YOU JUST A FLAVOR OF SOME OF THE GLOBAL WORK THAT WE DO. THIS GRANT IS DR. KELLEY LEE IN VANCOUVER TITLED "TOBACCO COMPANIES PUBLIC POLICY AND GLOBAL HEALTH," AND IT LOOKS AT THE IMPACT OR WHAT KELLY CALLS THE DUAL AND DYNAMIC RELATIONSHIP BETWEEN GLOBALIZATION AN TOBACCO CONTROL. AND I'LL BACK UP TO SAY I THINK WE'RE ALL FA WITH THE IMPACT OF GLOBALIZATION. IF YOU GO TO A GROCERY STORE OR SHOPPING MALL, THE PRODUCTS YOU BUY WILL BE PRODUCED ALL AROUND THE WORLD. GLOBALIZATION HAS ALSO HAD A PROFOUND IMPACT ON HEALTH, SOMETIMES POSITIVE, SOMETIMES NEGATIVE. WHAT KELLY'S GRANT IS FOCUSED ON IS LOOKING AT HOW THE TOBACCO INDUSTRY, WHICH HAS A GOAL OF MAINTAINING IF NOT INCREASING CIGARETTES SALES, HAS USED GLOBALIZATION, HOW IT HAS ADAPTED TO GLOBALIZATION AND ALSO HOW IT IS THOUGHT TO SHAPE GLOBALIZATION TO FURTHER ITS GOALS. SO FOR EXAMPLE, ONE TOPIC SHE LOOKS AT IS THE POTENTIAL FOR GLOBALIZATION TO INCREASE ILLEGAL SALES OF TOBACCO. FLY, ALTHOUGH I FEEL BADLY THAT WE DON'T HAVE TIME TO GO INTO THIS IN DETAIL, I WANT TO GIVE A SHOUT OUT TO OUR COLLEAGUES IN INTRAMURAL AND DCEG WHO DO SOME VERY IMPORTANT AND USEFUL WORK ON TOBACCO AND HAVE FOR MANY YEARS, AND WE COLLABORATE WITH AND REALLY VALUE THEIR PARTNERSHIP. SO NOW I'LL MOVE ON TO SOME OF OUR FORMAL NCI PAR PARTNERSHIPS. PROBABLY OUR MOST IMPORTANT PARTNERSHIP IS WITH THE OTHER NIH INSTITUTES, MANY OF WHOM DO WORK ON TOBACCO. NHLBI, NIDA, THE INSTITUTE OF CHILD HEALTH. YOU MAY BE AWARE THAT IN ADDITION TO THESE, NIH HAS NOW DEVELOPED A FORMAL PROCESS TO CREATE SYNERGIES AND BETTER INTEGRATE THE ADDICTION-RELATED WORK OF THREE INSTITUTES, NIGH NIDA, THE NATIONAL INSTITUTE ON DRUG ACCUSE BEUS, ALCOHOLISM AND ALCOHOL ABUSE, AND OF COURSE NCI. THIS FORMAL PROCESS IS NOW REFERRED TO AS THE COLLABORATIVE RESEARCH ON ADDICTION AT NIH OR CRAN. IT'S STILL A WORK THAT'S GETTING OFF THE GROUND BUT STILL HAS TREMENDOUS POTENTIAL BOTH TO IMPROVE SCIENCE AND PUBLIC HEALTH BECAUSE SOME -- OUR PERSPECTIVE IN TOBACCO, SO MUCH OF TOBACCO USE CO-OCCURS WITH BOTH ALCOHOL AND DRUG ABUSE, AND THERE IS A LOT TO BE LEARNED BOTH FROM A BIOLOGICAL AND PUBLIC HEALTH PERSPECTIVE. WE HAVE A STRONG AND EVOLVING PARTNERSHIP WITH FDA, I WON'T SAY MORE ABOUT THAT HERE BECAUSE YOU'LL HEAR ABOUT IT FROM LATER. WE COLLABORATE VERY CLOSELY WITH CDC'S OFFICE ON SMOKING AND HEALTH. I THINK IT'S A RARE DAY THAT SOMEONE IN OUR GROUP IS NOT EITHER ON THE PHONE OR EXCHANGING EMAILS WITH COLLEAGUES AT CDC. WE COLLABORATE TO PRODUCE WORKSHOPS, WE COLLABORATE ON PUBLICATIONS LIKE THIS ON THE BOTTOM, ON THE GLOBAL SMOKELESS TOBACCO EPIDEMIC. AND THEN OF COURSE YOU'LL HEAR LATER ABOUT THE SURGEON GENERAL'S REPORT, WHICH IS A CDC AND SURGEON GENERAL'S EFFORT, BUT I THINK IT'S WORTH NOTING THAT A TREMENDOUS AMOUNT OF NCI SUPPORTED RESEARCH GOES INTO MAKING THAT VOLUME, AND THIS IS ALSO AN OPPORTUNITY FOR ME TO THANK THE NEARLY TWO DOZEN PEOPLE FROM ACROSS NCI WHO HELPED REVIEW THAT VOL UNITED WE ALSO COLLABORATE CLOSELY WITH THE WORLD HEALTH ORGANIZATION ON PROJECTS OF GLOBAL SIGNIFICANCE. I WON'T SAY MORE ABOUT THAT HERE. SO I WANT TO TALK ABOUT JUST A FEW POTENTIAL FUTURE RESEARCH DIRECTIONS. THE FIRST RELATES TO BETTER ADDRESSING CANCER -- DIRECT USE IN A CANCER TREATMENT SETTING. THAT'S, OF COURSE, A TOPIC YOU'LL HEAR MORE ABOUT FROM DR. HERBS IT IN JUST A FEW MOMENTS. THIS SURGEON GENERAL'S REPORT IS ACTUALLY THE FIRST TO MAKE CUSIONS REGARDING CONTINUED TOBACCO USE AMONG CANCER PATIENTS AND SURVIVORS. IT ALSO POINTS OUT SOME IMPORTANT RESEARCH NEEDS THAT WE'D LIKE TO PICK UP ON, BOTH THOSE THAT RELATE TO BETTER UNDERSTANDING OF THE IMPACT OF CONTINUED TOBACCO USE IN THAT SETTING, BUT ALSO OBVIOUSLY EFFORTS TO DECREASE ITS USE. WE ALREADY HAVE A WORLD FULL OF DIVERSE TOBACCO PRODUCTS, AND MORE ARE TO COME. WE NEED A BETTER UNDERSTANDING OF THE CHEMISTRY AND PHYSICAL PROPERTIES OF THESE PRODUCTS, HOW THEY ARE USED, HOW THEY ARE MARKETED AND WHAT THEIR HEALTH EFFECTS ARE. THIS IS NOT JUST IMPORTANT FOR FDA, IT'S ALSO IMPORTANT FOR THE BROADER TOBACCO CONTROL COMMUNITY. WE CONTINUE TO NEED WAYS TO IMPROVE BOTH CESSATION AND PREVENTION, AND DR. FIORE WILL SOON TALK TO YOU ABOUT OUR EFFORTS IN SE SAYS CESSATION, SO I WANT TO SAY A FEW WORDS HERE ABOUT YOUTH PREVENTION. WE HAVE A NUMBER OF EVOLVING CHALLENGES WITH YOUTH. FIRST THE PROLIFERATION OF NEW PRODUCTS, WE'LL HEAR MORE ABOUT E-CIGARETTES LATER AS JUST ONE EXAMPLE. AND MANY OF THESE WILL BE ATTRACTIVE TO YOUTH. WE HAVE ALMOST A CONTINUOUSLY CHANGING MEDIA ENVIRONMENT, AND THAT HAS THE POTENTIAL BOTH TO PROMOTE BUT ALSO TO PREVENT TOBACCO USE, AND AGAIN, I THINK I ALSO MENTIONED THE EVOLVING INTERPLAY BETWEEN TOBACCO AND OTHER DRUG USE. FOR DECADES, MOST OF THE POLICY AND PROGRAM CHANGE HAS COME AT THE STATE AND COMMUNITY LEVEL AND THAT WILL PROBABLY BE THE -- THAT WILL PROBABLY CONTINUE TO BE THE LOCUST FOR MOST POLICY AND PROGRAM CHANGE, SO STUDYING THESE NATURAL EXPERIMENTS WILL CONTINUE TO BE VERY IMPORTANT BS AND I PUT UP ON THE SLIDE JUST TWO NEW NATURAL EXPERIMENTS, IF YOU WILL, THAT WE REALLY NEED TO STUDY. THE FIRST IS A POSITIVE DIRECTION, I THINK. I DON'T KNOW IF THIS CAN BE VISIBLE FROM THE BACK, BUT THE CITY OF NEW YORK HAS RECENTLY RAISED ITS AGE OF SALE OF TOBACCO PRODUCTS FROM 18 TO 21. IT'S NOT IN EFFECT BUT SHOULD BE SOON, AND THIS SHOULD HAVE A SUBSTANTIAL POSITIVE IMPACT ON REDUCING TOBACCO SALES TO YOUTH. CONVERSELY MARIJUANA SALES ARE MOVING ALONG IN COLORADO AND WASHINGTON AND MANY OTHER STATES ARE CONSIDERING LIBERALIZING THEIR MARIJUANA LAWS. WHATEVER YOU THINK ABOUT THOSE LAWS AND THE PURPOSES OF MARIJUANA, I THINK MOST PEOPLE IN THE FIELD FEEL THEY ARE NOT GOING TO HAVE A POSITIVE IMPACT ON TOBACCO USE. BUT THAT'S, AGAIN, SOMETHING WE NEED TO STUDY. BUT NAD, WE NOW LIVE IN WHAT I LIKE TO THINK OF AS A GLOBAL LABORATORY OF TOBACCO CONTROL. YOU'LL HEAR MORE LATER THIS AFTERNOON ABOUT THE LANDMARK W.H.O. FRAMEWORK CONVENTION ON TOBACCO CONTROL THAT'S THE INTERNATIONAL TOBACCO CONTROL TREATY, AND THAT HAS GALVANIZED TOBACCO POLICY AND PROGRAM EFFORTS AROUND THE WORLD, CREATING A WORLD LABORATORY FOR NCI RESEARCH TO STUDY, BOTH FOR ITS ASPECTS -- BOTH FOR ITS IMPACTS INTERNATIONALLY AND LESSONS BACK HOME. THE LAST SLIDE I WANT TO SHOW YOU BEFORE I CLOSE THE SESSION RELATES TO A SOCIAL NORM THAT WE HAVEN'T TALKED ABOUT, BUT I THINK IS REALLY CRITICAL: SOME OF THE MORE INNOVATIVE POLICY CHANGES WE THINK ABOUT FOR THE 21ST CENTURY ARE GOING TO REQUIRE REALLY RADICAL CHANGE AND REALLY RADICAL INNOVATIVE OR RADICAL, WHATEVER YOU WANT TO C IT, INTERVENTIONS WITH THE SOURCE OF THE EPIDEMIC, WHICH FOR MOST OF US WHO WORK IN TOBACCO CONTROL IS THE INDUSTRY ITSELF. THE PROBLEM IS THAT FOR A VARIETY OF DIFFERENT REASONS, AND WE DON'T HAVE ALL THE DATA WE NEED ON THIS, THIS, FOR EXAMPLE, IS A GALLUP SLIDE FROM A GALLUP POLL ASKING THE QUESTION, WHO IS TO BLAME FOR THE HEALTH PROBLEMS FACED BY SMOKERS IN THIS COUNTRY? WHAT YOU SEE IS A VERY STEADY ACCEPTANCE OF THE IDEA THAT IT IS THE SMOKER WHO IS TO BLAME. I THINK WE ALSO HEAR THIS FROM PATIENTS WITH LUNG CANCER, THEY FEEL BLAME FOR THEIR DISEASE. SO I DON'T THINK THIS IS ANY DIFFERENT LIKELY AMONG HEALTH PROFESSIONALS. BUT THAT'S IMPORTANT BECAUSE UNTIL WE BEGIN TO HAVE PUBLIC OPINION FOCUS ON WHAT IS THE REAL ROOT OF THE PROBLEM, WE'RE GOING TO HAVE DIFFICULTY PUTTING IN PLACE THE TYPES OF POLICY INTERVENTIONS WE NEED TO REALLY ADDRESS THE PROBLEM IN A MORE SUBSTANTIVE WAY. SO I THINK WE LOOK AT THIS PARTICULAR SOCIAL NORM AND RELATED FACTORS WILL BE VERY IMPORTANT. WITH THAT, I WILL CLOSE. >> MICHELLE, THANK YOU FOR THAT VERY THOROUGH, THOUGHTFUL REPORT. WE HAVE TIME FOR A FEW QUESTIONS BEFORE WE TRANSITION TO THE NEXT SPEAKER. PERHAPS I'LL START WITH ONE. I KNOW THAT THE NCI HAS BEEN THINKING ABOUT THE INFLUENCE OF -- I THINK YOU DESCRIBED IT AS MOVIE SMOKE AND THE EXPOSURE OF YOUTH THROUGH THAT MEDIUM. WHAT IS THE CURRENT ATTITUDE IN THAT INDUSTRY ABOUT EFFECTING CHANGE IN THIS REGARD? >> I THINK THERE ARE PROBABLY BETTER PEOPLE THAN ME TO ADDRESS THAT, BUT WHAT I WOULD SAY IS THAT WITH A LOT OF RESISTANCE, THERE ARE A LOT OF ACTIVE EFFORTS TO MOVE IT ALONG, AT CONGRESS, THROUGH THE ATTORNEY GENERAL, THERE HAS BEEN SOME PROGRESS, BUT THERE'S A TREMENDOUS AMOUNT OF RESISTANCE, I THINK, FOR BOTH PHILOSOPHICAL AND PROBABLY MONETARY REASONS, AND -- BUT I THINK WE ARE MAKING PROGRESS. I CAN TELL YOU THAT ONE OF THE GOALS OF THOSE WHO WORK IN THIS AREA IS TO HAVE MOVIES THAT PORTRAY TOBACCO USE AND PROBABLY ALSO ALCOHOL RECEIVE AN R RATING. TODAY A MOVIE RECEIVES AN R RATING IF IT USES FOUL LANGUAGE. FOUL LANGUAGE MAY NOT BE A GOOD THING BUT IT HASN'T KILLED ANYBODY LATELY THAT I'M AWARE OF. [LAUGHTER] >> THAT'S THE POINT THAT THEY MAKE. BUT AGAIN, IT'S ABOUT A SOCIAL NORM, PART OF THIS IS A SOCIAL NORM QUESTION, WHAT DO PEOPLE THINK, WHAT DOES THE PUBLIC THINK MERITS AN R RATING? WE HAVE NOT YET MOBILIZED ENOUGH PUBLIC OPINION TO MOVE IN A DEMOCRATIC SOCIETY FOR THIS TO HAPPEN. THAT BEING SAID, THERE IS A LOT OF ACTIVITY IN THIS REGARD AND I THINK THEY ARE HAVING AN EFFECT. >> FURTHER QUESTIONS? IF NOT, MICHELLE, THANK YOU ONCE AGAIN. [APPLAUSE] AND WE'LL MOVE TO JONATHAN SAMET, WHO AS YOU HEARD PLAYED AN INSTRUMENTAL ROLE IN P AND REVIEWING THE NEW SURGEON GENERAL'S REPORT, AND HE'LL GIVE US SOME PERSPECTIVE, BOTH HISTORICAL AND FUTURE-LOOKING. >> OKAY. THANK YOU. SO I'M GOING TO TELL YOU ABOUT THE REPORT, AND I'M GOING TO S WITH THE FIRST, 1964, BECAUSE OF THE IMPORTANT PRECEDENT THAT DEVELOPED WITH THAT REPORT, AND IN WITH 2013, YOU MIGHT NOTICE A SIZE DIFFERENCE. THE 2014 REPORT IS 900 PAGES PLUS 500 PAGES OF TABLES AND FIGURES PLUS WEB SUPPLEMENTS. SO I ONLY HAVE 20 MINUTES TO TELL YOU ABOUT 50 YEARS, SO HANG ON. SO BEFORE 1964, I HAVE TO START THERE, BECAUSE THE REPORTS WERE BORNE OUT OF A TIME WHEN THERE WAS CONTROVERSY. ROUGHLY AROUND 1950, THE FIRST REALLY CRITICAL SCIENTIFIC REPORTS, EPIDEMIOLOGICAL REPORTS, WENT ABOUT SHOWING VERY, VERY STRONG ASSOCIATIONS OF SMOKIN WITH LUNG CANCER. HERE ARE THREE OF THOSE CASE CONTROL STUDIES. A MEDICAL STUDENT TEAMED WITH A THORACIC SURGEON AND THERE ARE ACTUALLY OTHERS HERE'S DOLL, A KEY FIGURE, COMMENTING ON THE FACT THAT THERE WERE SOME DISEASES LINKED WITH SMOKING, A LIST THAT CONTINUES TO LENGTHEN. WHEN HE SAID THIS ABOUT 20 YEARS AGO, THE -- HAD BEEN DONE IN RESPONSE. 1953-IF FOUR-54, THEY SHOWED PAINTING THE BACKS OF MICE PRODUCED TIMMERS, AND AT THE AMERICAN CANCER SOCIETY THEY DID NOT THE STUDIES THAT HAD BEEN DONE BEFORE BUT SMOKERS' RATES OF LUNG CANCER COMPARED WITH THOSE OF NON-SMOKERS. THIS IS WHEN YOU COULD GET HAND DRAWN STUFF INTO THE BRITISH MEDICAL JOURNAL. SORT OF CHARMING. THE TOBACCO INDUSTRY TOOK NOTE AND IN 1954, THERE IS A FAMED MEETING OF THE TOBACCO INDUSTRY AND THE ADVERTISING FIRM AT W A STRATEGY WAS PUT INTO PLACE THAT LED TO WHAT EVENTUALLY WAS FOUND TO BE FRAUD AND RACKETEERING. AT THAT TIME, THERE WAS THE FRANK STATEMENT IN ALL NEWSPAPERS AND PERIODICALS AROUND THE COUNTRY, ADMITTING AND SAYING THAT THEIR PRODUCTS WERE SAFE AND THEY ACCEPTED RESPONSIBILITY, AND IT'S FROM THEN WE HAVE CLEAR DOCUMENTATION THAT, IN FACT, THEIR BEHAVIOR WAS QUITE THE OPPOSITE. A HISTORIAN AT STANFORD HAS WRITTEN A SPECTACULAR BOOK PUBLISHED ABOUT TWO YEARS AGO, THE GOLDEN HOLOCAUST, THAT HAS THE STORY FROM THE INDUSTRY'S OWN DOCUMENTS. THE SURGEON GENERAL IN THE 50s RELEASED TWO STATEMENTS. ONE ON EXCESSIVE CIGARETTE SMOKING, WHICH HE THOUGHT CAUSED DISEASE, WHATEVER EXCESSIVE MAY HAVE BEEN, THEN A STATEMENT IN 1959. IN 1962, THE U.K. ROYAL COLLEGE OF PHYSICIANS SAID THAT SMOKING CAUSED LUNG CANCER. SO BACKGROUND EVIDENCE WAS EMERGING IN THE 50s, THE TOBACCO INDUSTRY HAD ALREADY BEGUN ITS EFFORTS TO MAINTAIN CONTROVERSY LEADING TO THE 1964 REPORT. I'M GOING TO USE THIS DIAGRAM TO TELL YOU A LITTLE ABOUT THE HISTORY OF THE REPORTS. THIS IS TOBACCO CONSUMPTION, CIGARETTES PER ADULT OVER 18. 18 YEARS AND OLDER. IT'S NOT JUST SMOKERS, IT'S EVERYBODY. SO THERE WAS SORT OF A PEAK OF ABOUT 200 PACKS PER ADULT IN THE UNITED STATES IN THE EARLY 1960s, AND YOU CAN SEE NOW THE PROGRESSIVE FALL IN SOME OF THE KEY EVENTS THAT WILL START IN 1964, OF COURSE. SO IN 1964, THE REPORT WAS RELEASED. THIS REPORT ACTUALLY CAME AT THE REQUEST OF KENNEDY, WHO READ IT TO ADDRESS THE CONTROVERSY WITH INPUT FROM CERTAIN SENATORS WHO SAW A NEED FOR ACTION. THE REPORT WAS ONE OF A PUBLIC PRESS RELEASE TO DRAW MEDIA ATTENTION TO THE EVENT. SOMETHING THAT STILL CONTINUES, A LARGE TEAM SUPPORTING THE DEVELOPMENT OF THE REPORT, AND IN THIS CASE, THE SURGEON GENERAL STANDING WITH HIS REPORT. LIKE THE PRESENT REPORT, THE SURGEON GENERAL HIMSELF OR HERSELF DOES NOT DEVELOP THE REPORT, THIS IS NOW DONE BY THE CENTERS FOR DISEASE CONTROL AT THE OFFICE ON SMOKING AND HEALTH, WORKING WITH THE OFFICE OF THE SURGEON JERN GENERAL, BUT CLEARLY OTHERS WITHIN THE DEPARTMENT OF HEALTH AND HUMAN SERVICES. THIS IS THE FIRST COMMITTEE, YOU CAN NOTICE ASHTRAYS WHICH WERE APPARENTLY PRESENT. AT THE TIME I WAS AN UNDERGRAD AT HARVARD TAKING CHEMISTRY FROM CAESAR WHO BECAME INFAMOUS FOR INVENTION OF -- THAT MADE A NUMBER OF SUBSTANTIVE CONTRIBUTIONS. WILLIAM CLOC COCHRANE, IMPORTANT STATISTICIAN, AND OTHER LUMINARIES WERE BROUGHT OFTEN ON THIS COMUT COMIT EE BECAUSE THEY WERE THOUGHT TO BE NEUTRAL ON THIS CHARGED TOPIC. THEY PUT TOGETHER METHODS AND IN FACT I LOOK AT THIS '64 REPORT AS ONE OF THE FIRST EXAMPLES OF A SYSTEMATIC REVIEW. THEY GATHERED ALL OF THE EVIDENCE, THEY EVALUAED IT, AND THEY PUT TOGETHER CRITERIA FOR HOW THEY WERE GOING TO EVALUATE IT. CRITERIA, SO CALLED SURGEON GENERAL'S CRITER FOR CAUSATION, THAT ARE ESSENTIALLY STILL IN USE WITH LITTLE CHANGE. IT'S INTERESTING THAT THERE IS, IN FACT, A META-ANALYSIS INCLUDED IN THE REPORT, SOMEWHAT SILENTLY. THIS PULLS THE RESULTS OF SEVEN COHORT STUDIES EXPECTED AND OBSERVED DEATHS, PRESUMABLY BY COCHRANE, AND ACCOMPANYING THE TIMING OF THE SURGEON GENERAL'S REPORT, IN THE NEW ENGLAND JOURNAL, THERE WAS A PRESENTATION OF THE SAME INFORMATION IN A NOW EXTENDED PLAT SHOWING THE ASSOCIATION OF SMOKING WITH ALL CAUSE MORTALITY. SO ABOUT A 70% INCREASE IN RISK OF DYING FOR SMOKERS COMPARED TO NEVER SMOKERS. SO KEY FINDINGS AT THE TOP, SMOKING CAUSES LUNG CANCER IN MEN. THE CONCLUSION DID NOT EXTEND TO WOMEN AT THE TIME BECAUSE OF LIMITED EVIDENCE. CONCLUSIONS RELATED TO CHRONIC BRONCHITIS, A COMMENT ON CORONARY HEART DISEASE, AND THE INCREASE IN ALL CAUSED MORTALITY. BUT MOST IMPORTANTLY, IN SETTING THE PATTERNS FOR THE REPORT, THERE WAS A COMMENT ON THE IMPORTANCE OF THE FINDINGS AND THE NEED FOR ACTION BUT NOT SPECIFIC POLICY RECOMMENDATIONS. SO THE REPORT SUMMARIZES AND SYNTHESIZES SCIENTIFIC EVIDENCE, LEAVING THE POLICY FOR OTHER VENUES. SO TO CHARGE FROM 1964 TO NOW, A FEW REPORTS THAT I'LL HIGHLIGHT, 1972, THE FIRST COMMENT ON INDOOR AIR POLLUTION FROM TOBACCO SMOKE IN A CHAPTER CALLED TOBACCO SMOKE POLLUTION. 1979, THE ENORMOUS REPORT DONE OVER JOSEPH CALIFANO THAT REVITALIZED THIS SERIES OF REPORTS AND COVERED LITERALLY EVERY ASPECT OF SMOKING AND HEALTH. 1986, SURGEON GENERAL KOOP'S REPORT ON SECONDHAND SMOKE WHICH HAD IMMEDIATE IMPACT. I WAS ONE OF THE EDITORS FOR THAT REPORT, AND THIS IS OUR TEAM AS WE WERE VISITING KOOP AT HIS HOME, WHICH IS JUST ACTUALLY AROUND THE CORNER. DON SHOPLAND, IN FACT, WAS A STAFF MEMBER JUST OUT OF HIGH SCHOOL IN THE 1964 REPORT AND REMAINS ACTIVE. 1988, STILL SURGEON KOOP, THE FIRST TIME THAT THE REPORTS ADDRESSED NICOTINE ADICK, FINDINADDICTINGAGENT, KNOWN TO THE TOBACCO INDUSTRY LONG BEFORE. THE 2000 REPORT THAT LOOKED AT POLICY AND WHAT WORKS, 2004 WHEN WE AGAIN REVIEWED THE HEALTH CONSEQUENCES OF ACTIVE SMOKING AND UPDATED IN GENERAL THE APPROACH TO DEVELOPING THESE REPORTS. JUST TO EMPHASIZE THE TREMENDOUS TEAM WORK INVOLVED IN PUTTING TOGETHER DOCUMENTS OF THIS MAGNITUDE, THIS IS SOME OF US AT THE RELEASE OF THE 2004 REPORT, THEN IN 2006, WE DID PASSIVE SMOKING 20 YEARS AFTER THE '86 REPORT. THIS WAS THE TIME WHEN THE S WERE GOING SMOKE-FREE AND I WAS ACTUALLY GRATIFIED TO SEE THE FINDINGS IN THIS REPORT IN USE WITHIN DAYS OF ITS RELEASE IN 2006. SO AGAIN, THE MEDIA EVENT OF THE RELEASE HERE NOW THE SURGEON GENERAL. THE CONCLUSIONS ARE SCIENTIFIC BUT CARRY POLICY IMPLICATIONS, SO FOR EXAMPLE, 2006, NO RISK THREE LEVEL OF EXPOSURE TO SECONDHAND SMOKE WITH EVIDENT POLICY IMPLICATIONS. THEN IN 2010, A REPORT ON MECHANISM, A VERY DEEP LOOK AT THE SCIENCE WITH NOW THE WORK ON MECHANISMS SUPPORTING THIS SAME COMMENT ABOUT NO SMOKE FREE LEVEL. AGAIN, THE REPORTS STAY SILENT ON WHAT POLICIES FOLLOW BUT CLEARLY A POLICY LEVER. AGAIN, THE RELEASE OF THAT REPORT WITH IMPORTANT FIGURE -- THE SECRETARY HAS BEEN VERY INVOLVED WITH THESE REPORTS, HOWARD A FRIEND FOR A LONG TIME IN THE TOBACCO CONTROL WORK, AND REGINA BENJAMIN, THE SURGEON GENERAL THEN. SO YOUTH 2012, VERY IMPORTANT REPORT LED BY CHERYL PERRY THAT ADDRESSED SMOKING IN YOUTH, MEDIA MARKETING AND SO ON. THEN FINALLY, 2014, SO HERE WE ARE, THIS IS SOME OF THE CORE PEOPLE IN THE TEAM. TIM MCPHEE RUNS THE OFFICE ON SMOKING AND HEALTH, THIS REPORT WAS RELEASED AT THE WHITE HOUSE, AND THIS IS JUST A PICTURE OF THE RELEASE. THE SECRETARY, TOM FRIEDMAN, A SURGEON GENERAL, HERE HE IS. I HAVE TO SAY, HE DID AN ABSOLUTELY TERRIFIC JOB. HE PUNCTUATED HIS COMMENTS ONE AFTER THE OTHER BY SAYING -- AND I CAN'T DO IT AS HE DID, ENOUGH IS ENOUGH. AND I DON'T KNOW HOW MANY ENOUGH IS ENOUGHS WE HEARD, BUT IT WAS A LOT. IN FACT AFTER A WHILE, WE WERE SAYING ENOUGH IS ENOUGH OF ENOUGH IS ENOUGH. BUT HE REALLY MADE THE POINT THAT THE EVIDENCE HAS STACKED UP. HERE'S HOWARD SPEAKING. I WANT TO HIGHLIGHT A FEW OF THE MAJOR CONCLUSIONS. THE VOLUME -- EE BRICK, SHOULD YOU WANT TO DOWNLOAD IT AND CARRY IT AROUND WITH YOU, BECAUSE YOU DON'T WANT TO CARRY IT AROUND. BUT JUST TO SHOW YOU A FEW OF THE MAJOR CONCLUSIONS THAT CAME OUT, SO THE FIRST HIGHLIGHTS THE EENORMITY OF THE CONSEQUENCES OF SMOKING AND THE SECOND POINTS TO THE ROOT CAUSE, WHICH HAS BEEN DISCUSSED. I THINK IT WAS VERY IMPORTANT TO HAVE THIS CONCLUSION IN THE DOCUMENT, TOBACCO EPIDEMIC INITIATED AND SUSTAINED BY THE STRATEGIES OF THE TOBACCO INDUSTRY, AND NOW WITH THE DEPARTMENT OF JUSTICE LITIGATION IN ACCESS TO THE DOCUMENTS CAN CLEARLY STATE THAT THE INDUSTRY HAS DELIBERATELY MISLED THE PUBLIC. WE HAD A NUMBER OF CONCLUSIONS RELATED TO THE CAUSATION OF DISEASE. THE MID SECTION OF THE REPORT WAS RELATED TO SMOKING AND DISEASE, INCLUDING HAD VERY IMPORTANT CHAPTER AND NEW CONCLUSIONS RELATED TO SMOKING AND PEOPLE WHO HAVE CANCER. AND I THINK THERE'S CAUSE FOR ACTION, I KNOW THE AACR IS TAKING ACTION AND HAS THEIR OWN DOCUMENT AND POSITION PAPER ON THIS, BUT THERE IS AN EXCELLENT REVIEW DONE FOR THIS CHAPTER. I THINK REMARKABLE TO ME IS THAT EVEN 50 YEARS AFTER THE FIRST REPORT, THE LIST JUST GETS LONGER. AND THIS IS BECAUSE WE'VE NOW FOLLOWED PEOPLE WHO HAVE SMOKED THROUGHOUT THEIR LIVES, BEING ABLE TO SEE THE FULL COURSE OF WHAT HAPPENS TO THEM. RISING DISEASE RISKS IN WOMEN, THE OLD ADAGE IF WOMEN SMOKE LIKE MEN, THEY'LL DIE LIKE MEN IS TRUE. AND THE RELATIVE RISK FOR SMOKING IN WOMEN NOW EQUAL THOSE FOR MEN. THEN COMMENTS ON GENERAL CONSEQUENCES FOR THE SMOKER. THIS IN RED SHOWS THE NEW DISEASES ADDED TO THE LIST FOR ACTIVE SMOKING. PERHAPS SOME SURPRISES, RHEUMATOID ARTHRITIS, FOR EXAMPLE, MALE SEXUAL FUNCTION-ERECTILE DYSFUNCTION FOR THE FIRST TIME REACHED THE CAUSAL LEVEL, COLORECTAL CANCER AND LIVER CANCER ADDED, AND FOR PASSIVE SMOKING, THE ADDITION OF STROKE ADDED TO CORONARY HEART DISEASE, WHICH HAD ALREADY BEEN ON THE LIST. IN TERMS OF THE POLICY SEGMENT OF THE DOCUMENT -- THERE WERE IMPORTANT CONCLUSIONS, THERE'S COMMENTS ABOUT THE SUCCESS OF TOBACCO CONTROL, AND THE POSSIBILITY OF MAKING IMPORTANT GAINS WITH USING WHAT WE ALREADY KNOW, THEN THE VERY IMPORTANT COMMENT OF CIGARETTES AND OTHER COMBUSTED TOBACCO PRODUCTS LEADING INTO LATER DISCUSSIONS, RAPID ELIMINATION OF THEIR USE WILL DRAMATICALLY REDUCE THIS BURDEN. THEN JUST A COMMENT ON THE IMPORTANT POLICY CONCLUSIONS THAT COME AT THE END, IN THE LAST TWO CHAPTERS. WE REVIEW AT LENGTH WHAT WE KNOW ABOUT WEB WORKS AND HOW THIS KNOWLEDGE CAN BE PUT INTO ACTION. I THINK THE IMPORTANT CONCLUSION INCLUDED WITH THIS REPORT AND ELSEWHERE IS THAT BUSINESS AS USUAL DOES NOT BRING THE EPIDEMIC TO A CLOSE FAST ENOUGH. AND THAT MORE HAS TO BE DONE. WE HAVE INTERVENTIONS AND YOU MAY NOT BE AWARE THAT, IN FACT, THERE HAVE BEEN VERY AGGRESSIVE -- TOBACCO CONTROL STRATEGIC PLAN THAT IS VERY IMPORTANT DOCUMENT, AND THERE IS DISCUSSION OF THE SO-CALLED END GAME, THAT IS MOVING TO A TIME WHEN, IN FACT, CIGARETTE USE WILL PLUNGE TO SOME LEVEL AT WHICH WE CAN REALLY CONSIDER THE EPIDEMIC AND THAT WE ARE CLEARLY NOT THERE YET. AND THEN THE LAST CHAPTERS, THE LOOK FORWARD WITH SOME KEY POLICY MESSAGES, THINGS THAT MIGHT BE DONE, TAXATION WORKS AND IT'S CRITICAL, THE OPPORTUNITIES FOR PREVENTION THROUGH THE AFFORDABLE CARE ACT, MICHA FIORE WILL BE TALKING ABOUT THIS TOPIC SO I'LL LEAVE THAT. WE'LL ALSO BE HEARING FROM FDA, WHICH HAS VERY IMPORTANT AUTHORITY TO BE USED, AND OTHER COMMENTS. SO WE HAVE MUCH THAT CAN BE DONE WITH WHAT WE ALREADY HAVE IN HAND. SO THESE ARE SOME OF THE KEY MESSAGES LOOKING FORWARD FOR SOME OF THE POSSIBILITIES. REDUCING USE OF COMBUSTIBLE PRODUCTS, A PROPOSAL 20 YEARS AGO TO REDUCE NICOTINE CONTENT OF CIGARETTES, THAT IS SOMETHING THAT THE FDA CAN ENTERTAIN. THEY JUST CANNOT GO TO ZERO NICK NICOTINE IN CIGARETTES. THE ROLE OF NON-COMBUSTIBLES, WHICH WE'RE GOING TO TALK ABOUT AT A PARTICULARLY CRITICAL MOMENT WITH THE RISING USE OF E-CIGARETTES, AND THE MESSAGE, USE EVERYTHING BUT WE HAVE BUT BETTER. IN THESE REPORTS, WE DID DO A LOT OF MESSAGING FOR THE PUBLIC OR WITH THE REPORTS, SO FOR ALL OF THEM SINCE THE 2004 REPORT, THERE HAVE BEEN DOCUMENTS AND OTHER MEDIA INTENDED TO REACH TO THE PUBLIC AND REACH TO THE PUBLIC IN MULTIPLE LANGUAGES. SO THESE ARE JUST SOME EXAMPLES OF THE MESSAGING. SO THE AFTERMATH OF THE REPORT, THERE WAS RELATIVELY EXTENSIVE MEDIA COVERAGE, AND HERE'S A LITTLE BIT OF IT. SMOKING-RELATED ILLNESSES, THE LIST GROSS LONGER, MORE DEATHS, MORE TYPES OF ILLNESSES. NEW TARGET, E-CIGARETTES, THAT'S NOT EXACTLY RIGHT BUT WE CERTAINLY SPEAK TO THE RISING ISSUE OF NON-COMBUSTIBLES. NEW RESOLVE, THAT IS TRUE AND THE NEW RESOLVE EXTENDS WIDELY, REACH COMMUNITIES WHO CONTINUE TO SMOKE, THE DATA THAT MICHELLE PRESENTED HIGHLIGHTED THE HETEROGENEITY OF THE EPIDEMIC, WHICH IS SOMETHING THE REPORT DOCUMENTS IN GREAT DETAIL. IT'S NOT ONE EPIDEMIC, BUT IT'S MULTIPLE EPIDEMICS. AND EACH ONE NEEDS A PLAN AND A SOLUTION. THE TOBACCO FIRMS, OF COURSE, INVOLVED. AND I GUESS LOOKING TO THE 100TH REPORT, I PROBABLY WON'T BE THERE, BUT HOPEFULLY IT WILL BE ONE THAT LOOKS TO A NEVER SMOKING POPULATION, AND DECADES OF CHILDREN AND GENERATIONS THAT ARE SMOKE-FREE. SO THANKS, ROUGHLY ON TIME. >> DIRECTOR JACKS: PRETTY GOOD. JOHN, THANK YOU. [APPLAUSE] THANKS FOR THAT PRESENTATION AND YOUR HARD WORK OVER ALL THESE MANY YEARS ON THIS VERY IMPORTANT PROBLEM. ANY QUESTIONS FOR JOHN AT THIS TIME? THANK YOU, JOHN. ALL RIGHT. WE WILL MOVE ALONG AND HEAR FROM ROY HERBST FROM YALE, AND HE'LL TALK TO US A BIT ABOUT THE SCIENCE OF TOBACCO'S EFFECTS IN LUNG CANCER AND OTHER CANCERS, GENETIC EFFECTS, INFLUENCES ON PROGNOSIS AND TREATMENT, AND OTHER MATTERS. ROY. >> THANK YOU VERY MUCH. IT'S TRULY AN HONOR TO BE HERE AND TELL YOU A LITTLE BIT ABOUT THE PATHOPHYSIOLOGY OF TOBACCO-INDUCED CANCERS. AS I WAS PREPARING FOR THIS TALK AND I SAW I'M BETWEEN DR. SAMET AND DR. FIORE, I THOUGHT I'D GIVE YOU THE PERSPECTIVE OF A MEDICAL ONCOLOGIST. I TREAT MANY PATIENTS WITH LUNG AND HEAD AND NECK CANCER. WE NEED TO UNDERSTAND IT SO WE CAN TREAT IT BETTER, A BIT ABOUT EPIDEMIOLOGY AND MECHANISM WITH A FOCUS ON LUNG AND HEAD AND ME CAN CANCERS. THEN I'D LIKE TO SHOW YOU SOME OF THE WORK ABOUT THE AACR/NCI EFFORTS RELATED TO TOBACCO C IN PATIENTS GETTING TREATMENT FOR CANCER. I THINK THIS WILL BE INTERESTING TO YOU BECAUSE MANY PATIENTS ON TRIAL CONTINUE TO SMOKE AND WHAT EFFECT DID THAT HAVE ON THE OUTCOME OF THEIR THERAPY. THEN TALK ABOUT HOW WE NEED TO INCORPORATE KNOWLEDGE AND SURVEYS ABOUT TOBACCO USE IN CLINICAL TRIALS, WHICH IS NOT BEING DONE. THEN AT THE VERY END, I'LL BE ABLE TO TELL BUT SOME APPROACHES TO TREATING TOBACCO INDUCED DISEASE BECAUSE WE DO NEED TO THINK ABOUT THE FORMER SMOKERS AND EVEN SOME CURRENT SMOKERS HEUND CAN WE TREAT THE TOBACCO-INDUCED CANCERS, WHAT NEW IDEAS ARE THERE FOR THEM. SO WHAT ABOUT THE PATHOGENESIS? SO YOU ALREADY SAW THE SLIDE FROM DR. SAMET. I WON'T GO THROUGH THIS IN TOO MUCH DETAIL, THERE ARE MORE THAN 18 DIFFERENT TYPES OF CANCER THAT ARE NOW DIRECTLY RELATED TO SMOKING AND AS YOU HEARD IN THE MOST RECENT REPORT, LIVER AND COLORECTAL WERE NOW ADDED TO THE LIST. TOBACCO ACTUALLY CAUSES 85% OF LUNG CANCERS. 1 IN 3 CANCER DEATHS IN THE U.S. IS DIRECTLY RELATED TO TOBACCO, AND THE 2004 REPORT, AS I MENTIONED, ADDED A COUPLE OF NEW ONES. THIS IS JUST AN EXAMPLE OF SOME OF THE NUMBERS. THE NUMBERS ARE HUGE. THESE ARE U.S. NUMBERS AND YOU CAN SEE SOME OF THE CANCERS RELATED TO SMOKING AT SOME OF OUR MOST COMMON CANCERS. IN FACT, THEY ARE OUR MOST COMMON CANCERS AND VERY LARGE NUMBERS, LUNG CANCER, HEAD AND NECK CANCER LEADING THE LIST. I KNOW THAT WE'RE GOING TO TALK A LITTLE LATER ABOUT THE GLOBAL CONSEQUENCES OF TOBACCO USE, AND HERE H YOU CAN SEE WORLDWIDE, JUST ENORMOUS NUMBERS OF DEATHS DUE TO TOBACCO-RELATED CANCERS. SO OF COURSE THE MAJOR REASON WHY WE'RE DISCUSSING IT TODAY. WELL, WHAT ABOUT -- WHAT DO WE KNOW ABOUT SMOKING AND CANCER? CIGARETTE SMOKE CONTAINS MORE THAN 7,000 COMPOUNDS, ALMOST MORE THAN 60 ARE KNOWN CARCINOGENS. THE LIST CONTINUES TO GROW. IN FACT, 600 OF THESE AT LEAST ARE ADDED TO ENHANCE THE FLAVOR A THE NICOTINE ABSORPTION. WHICH IS OF COURSE THE ADDICTIVE ELEMENT. INHALING THIS MIX OF CHEMICALS INDUCES TISSUE INJURY AND CHANGES IN THE CELLULAR MICRO ENVIRONMENT FOSTERING PROLIFERATION AND TRANSFORMATION OF CANCER. MUTATIONS CAN RESULT AS YOU KNOW IN LOSS OF NORMAL GROWTH CONTROL, SILENCING OF TUMOR SUPPRESSOR GENES, PROMOTION OF CANCER. AND THEN PATIENTS WHO SMOKE CAN DEVELOP MULTIPLE CANCERS, EVEN AFTER YOU TREAT THE FIRST ONE AND PRIMARY CANCERS, SECONDARY CANCERS ARE NOT UNCOMMON. AND I SHOW THIS SLIDE, I COULD HAVE TAKEN MANY FROM THE WORK OF DR. PITO, PROBABLY WELL-KNOWN TO MOST OF NEW THIS GROUP. IF YOU LOOK AT THE RISK OF STOPPING SMOKING AND THE DEATH FROM LUNG CANCER BY AGE 75, YOU CAN SEE CERTAINLY THE RISKS ARE HIGHEST IN THE CURRENT SMOKER, BUT THERE CONTINUE TO BE RISKS FOR THE FORMER SMOKER AS WELL. THAT'S WHY IT'S VERY IMPORTANT EVEN IF WE ARE COMPLETELY SUCCESSFUL, AND I HOPE WE ARE, BY 2064, WE STILL NEED TO THINK OF THOSE PATIENTS WHO HAVE SMOKED WHO HAVE STOPPED, HOW CAN WE TREAT THEIR DISEASE. SO HOW DO WE THINK ABOUT THIS, WE WROTE A REVIEW ARTICLE A NUMBER OF YEARS BACK AND WE WANTED TO SORT OF AT THIS POINT IN 2008, THE FIELD IS MOVING TO THE POINT WHERE WE NOW THINK OF LUNG CANCER AS EITHER NON-SMOKER'S LUNG CANCER SHOWN BY THE PINK LUNGS OR THE SMOKER'S CANCER SHOWN BY GRAY LUNGS. THERE IS A PROGRESSION FROM TOBACCO SMOKE, YOU DEVELOP THESE SO CALLED CLONAL PATCHES, BASED ON A WORK OF A NUMBER OF PULMONOLOGISTS. THESE PATCHES OF CELLS, THESE PREMALIGNANT LESIONS, WE THEN OF COURSE -- THEY EVOLVE INTO EARLY STAGE LUNG CANCER. MAJOR EFFORTS IN LUNG CANCER SCREENING BASED ON THE NCI FUNDED NLST TRIAL, WE TRY TO INTERVENE EARLY EITHER HEER HERE OR HERE, THEN OF COURSE WHEN CANCER DEVELOPS TO THE ADVANCED STAGE, IT'S VERY HARD TO TREAT. NOW THIS IS WORK OF KI HONG AND PEOPLE THAT HAVE STUDIED WITH HIM. LOOKING AT THE MOLECULAR CARCINOGENESIS OF HEAD AND NECK CANCER. YOU CAN SEE THEY'RE VERY WELL-DEFINED CHANGES THAT ARE INVOLVED IN THE PROGRESSION OF SMOKING-RELATED CANCER. THIS OF COURSE THE AREA WHERE EFFORTS OF PREVENTION HAVE FOR THEM AND CONTINUE TO BE VERY IMPORTANT AND WE NEED TO UNDERSTAND THE MECHANISMS OF PATHOGENESIS FOR MORE EFFECTIVE THERAPY. HERE YOU HAVE LOOKING AT SQUAMOUS CELL LUNG CANCER. AGAIN, VERY WELL-DEFINED PHENOTYPIC CHANGES, IN THE AREA OF GENOMIC TESTING, MUCH MORE SPECIFIC AS TO WHAT THE ABNORMALITIES ARE, AND HOPE WOULD BE THAT WE CAN INTERVENE EARLY FOR PREVENTION AND MORE EFFECTIVE THERAPY. THEN JUST A FEW MORE SLIDES ON THIS. P53, WHICH IS OFTEN -- WITH TOBACCO INDUCED CANCER, YOU CAN SEE THERE ARE SPECIFIC HOT SPOTS THAT HAVE BEEN IDENTIFIED, AND AGAIN, THIS OF COURSE BEING A MAJOR TARGET, THAT'S BEING DEVELOPED BY MANY INVESTIGATORS IN THIS ROOM. THEN TO BRING OUT THE POINT THIS IS A FIELD EFFECT, SMOKING IN THE LUNGS, FOR EXAMPLE, CAN AFFECT THROUGHOUT THE BRONCHIAL TREE, YOU HAVE TO THINK ABOUT EARLY AND LATE LESIONS IN MULTIPLE AREAS FOR PRIMARY AND SE PRIMARY TUMORS. SO THIS SLIDE PUTS IT ALL INTO ONE SUMMARY SLIDE, THE IDEA THAT YOU CAN HAVE CIGARETTE SMOKING, THAT THIS ON THE UPTAKE OF THE CARCINOGENS WHICH I ALREADY MENTIONED, CERTAINLY METABOLIZED DIFFERENTLY BY DIFFERENT PATIENTS, DIFFERENT PEOPLE, WHY SOME PEOPLE DEVELOP DISEASE AND OTHERS DON'T, THE EFFECT ON MUTATIONS AND RESULTING IN ACTIVATION AND LOSS OF TUMOR SUPPRESSOR GENES. I DON'T THINK I NEED TO SAY MUCH MORE TO THIS ROOM THAT THIS IS A MAJOR AREA FOR ALL THE CANCER CENTERS, THE WORK WE DISCUSSED TODAY. ONE THING THAT'S QUITE INTERESTING, IF YOU LOOK AT THE FIELD, THERE'S BEEN AN ENORMOUS AMOUNT OF WORK RECENTLY ON THE ADENOCARCINOMA AND SPECIFICALLY EGFR AND ALK MUTATIONS BECAUSE THOSE ARE THERAPEUTICALLY TREATABLE. I THINK THERE NEEDS TO BE MORE EMPHASIS FOR THE SMOKING RELATED LUNG CANCERS. THIS PURPLE AREA OR KRAS, THIS IS ALMOST ALWAYS ASSOCIATED IN PATIENTS WITH LUNG CANCER AND CAN BE AS MANY AS 30% OF THE PATIENTS WITH ADENOCARCINOMA. THERE'S ONE DESCRIBED MUTATION THAT SHOULD ACTUALLY BE A FOCUS FOR OUR WORK. THE SQUAMOUS WORLD, THERE HASN'T BEEN MUCH PROGRESS IN MANY YEARS, ALTHOUGH NOW WITH THE TCGA BEGINNING TO IDENTIFY THE MUTATIONS THAT ARE INVOLVED. KEEP THAT IN THE MIND BECAUSE AT THE END, I'LL TELL YOU ABOUT A CLINICAL TRIAL DESIGNED FOR SMOKERS, FORMER SMOKERS TO TREAT THESE RENALES, MUTATIONS. SO I'M GOING OH OH TELL YOU A LITTLE BIT ABOUT WORK THAT WE'VE DONE WITH THE AACR AND WITH STEPHANIE LAND, DR. BLOCK AND OTHERS AT THE NCI RELATED TO TOBACCO CONTROL. DR. -- HAS BEEN VERY SUPPORTIVE OF THESE EFFORTS, THAT'S TO LOOK AT TOBACCO USE IN PATIENTS RECEIVING TREATMENT FOR CANCER. AND HOW IT IMPACTS ON CLINICAL TRIALS. SO ABOUT 4 1/2 YEARS AGO -- CALLED ME AND SAID, HEY, ROY, THEY HAVEN'T REVISED THE TOBACCO STATEMENT IN MORE THAN 25 YEARS, THE AACR. COULD YOU PUT A COMMITTEE TOGETHER? THEY ACTUALLY HELPED ME WITH THAT. AND CAN WE START TO LOOK AT THIS. THAT WAS RIGHT AT THE TIME WHEN THE FAMILY TOBACCO ACT WAS ABOUT TO BE PASSED, THE IDEA WOULD BE THAT A GROUP THAT WAS FOCUSED ON ACTIVE CANCER COULD HELP INFORM SOME OF THAT -- THE USE OF FUNDS AND SOME OF THE RESEARCH IN THAT AREA. WE PUT OUT A TOBACCO STATEMENT IN CANCER RESEARCH COINCIDING WITH THE AACR MEETING THAT YEAR WHICH INCLUDED RECOMMENDATIONS FOR HOW TO PREVENT TOBACCO USE, TREATING TOBACCO ADDICTION AND FOSTERING CESSATION, REDUCING EXPOSURE TO SECONDHAND SMOKE, AND ADDRESSING TOBACCO-RELATED CANCER. BUT THEN AS WE THOUGHT WHAT CAN WE DO, THE COMMITTEE MEETS MULTIPLE TIMES A YEAR, WE'VE BEEN TO THE HILL QUITE OFTEN, SPOKEN AT THE NCI AND A NUMBER OF OTHER PLACES. WE WERE QUITE CONCERNED, AND THIS CAME FROM ELLEN GRITS FROM INDIANA, GRAHAM WARREN AND OTHERS TO ADDRESS CANCER USE BY PATIENTS AND HOW CAN WE FACILITATE CESSATION THERE. WHY IS THAT IMPORTANT? WE WANT TO PROVIDE PATIENTS IN ALL SETTINGS INCLUDING CLINICAL TRIAL WITH EVIDENCE-BASED ASSISTANCE. WHICH IS NOT ALWAYS DONE, AS YOU'LL SEE. W ALSO WANTED TO EVALUATE CON FOUNDING EFFECTS OF TOBACCO ON ON -- INTERESTINGLY, CANCER PATIENTS WHO SMOKE HAVE WORSE OUTCOMES INCLUDING HIGHER CANCER-SPECIFIC MORTALITY AND THE RISK OF SECONDARY PRIMARIES AS MENTIONED. SIMPLE PHARMACOLOGY WILL TELL YOU WITH WITH MANY OF THESE SMALL MOLECULES, INHIBITORS THAT CAN BE INEFFECTIVE IN SOME CASES IN PATIENTS WHO SMOKE BECAUSE OF DIFFERENTIAL METABOLISM. HERE IS SOME DATA, I GOT THE SLIDES FROM STEPHANIE AND I APPRECIATE THAT, THE RELATIVE RISK OF ALL CAUSED MORTALITY IN CURRENT SMOKERS IS 1.5 RELATIVE TO NEVER SMOKERS AND 1.3 RELATIVE TO FORMER SMOKERS. THE EVIDENCE SPEAKS FOR IT SELF, AND THE RELATIVE RISK OF CANCER-SPECIFIC MORTALITY IN CURRENT SMOKERS IS 1.6, FORMER SMOKERS, 1.05. SO CLEARLY THERE'S AN IMPETUS FOR LOOKING AT SMOKING, PATIENTS THAT HAVE CANCER ALREADY, TO WORK TO HAVE THEM STOP SMOKING. SO THERE ARE MANY QUESTIONS AND I CAN'T ADDRESS THEM ALL TODAY, BUT IF YOU LOOK AT CURRENT APPROACHES TO DATA COLLECTION, SMOKING USED BY PATIENTS THAT ARE RECEIVING THERAPY FOR CANCER IS NOT WIDELY ADDRESSED IN TRIALS OR PRACTICE. THAT'S CHANGING NOW WITH MEANINGFUL USE AND OTHER THINGS, BUT IT REALLY WAS NOT WIDELY DONE. INCONSISTENT TOBACCO USE ASSESSMENT METHODS, NO STANDARDIZATION, SO IF YOU WANT TO GO BACK AND SEARCH THIS, GOOD LUCK, AND LITTLE FOLLOW-UP DURING OR AFTER TREATMENT. SO WE ACTUALLY DID THROUGH OUR GROUP, GRAHAM WARREN AND OTHERS, A SURVEY, AND WE LOOKED AT NCI FUNDED CANCER CENTERS, A SUBSET OF THE 68 THAT YOU DISCUSSED TODAY, AND FEWER THAN 50% INCLUDE TOBACCO USE AS A VITAL SIGN IN THE MEDICAL RECORD. THEN WE LOOKED AT NCI FUNDED PHASE III COOPERATIVE GROUP TRIALS. 22% RECORD CIGARETTE SMOKING STATUS AT ENROLLMENT, ONLY 22%, AND ONLY 4% DURING FOLLOW-UP. SO THIS IS CLEARLY SOMETHING THAT WE KNOW SPECIFICALLY -- NOW THAT WE KNOW THE EFFECT AND THE OUTCOME, THIS NEEDS TO CHANGE. SO WITH THE AACR'S HELP, WITH STEPHANIE AND THE NCI, WE'RE WE ACTUALLY COMBINED OUR MEETING THIS FALL OF THE TOBACCO TASK FORCE FROM AACR WITH THE NCI GROUP, AND WE ACTUALLY MET HERE IN BETHESDA, AND WE OF COURSE HAVE MET MANY OTHER TIMES THROUGH CONFERENCE CALLS, WRITING GROUPS AND SO FORTH, AND THE GOAL IS TO DEVELOP RECOMMENDATIONS FOR ASSESSING AND DOCUMENTING TOBACCO USE IN CLINICAL TRIALS. A AND TO IDENTIFY RESEARCH PRIORITIES. NOW OF COURSE THE PROBLEM IS CLINICAL TRIALS ARE ALREADY QUITE CUMBERSOME WITH DATA AND MANY OF THEM ARE NOT AS RESOURCED AS YOU'D LIKE THEM TO BE, SO CAN YOU ADD THAT MUCH MORE DATA COLLECTION TO THESE TRIALS? SO WE TRIED TO COME UP WITH A MIN MUP SET OF QUESTIONS THAT SHOULD BE INCLUDED IN AN NCI-SPONSORED CLINICAL TRIAL. ACTUALLY THAT SHOULD BE IN ALL TRIALS. WE CAME UP WITH A MINIMUM SET OF ITEMS, HERE OF COURSE IS A LONGER MENU, NEIL AND MARGO HAVE DEVELOPED AN EVEN LONGER AND AGAIN, IT WOULD BE GREAT IF WE COULD HAVE ALL THIS EPIDEMIOLOGIC INFORMATION BECAUSE THAT CAN ALLOW US TO THEN CORRELATE THAT WITH ALL THE GENOMIC DATA THAT WE'RE GETTING IN THIS DAY AND AGE. THEN WE RECOMMEND THIS FOR THE NCTN TRIALS IN DEVELOPMENT. SO HERE IS JUST A CUT TO THE CHASE. HERE'S A TIER ONE, NOT OFFICIALLY APPROVED YET, I DON'T THINK, BUT QUITE OFTEN AS WE'RE DEVELOPING THESE, JUST THESE FOUR SIMPLE QUESTIONS. HAVE YOU EVER SMOKED 100 PLUS CIGARETTES IN A LIFETIME, HOW LONG SINCE YOU'VE SMOKED, HOW MANY YEARS HAVE YOU SMOKED, AND WHAT ARE THE AVERAGE NUMBER OF CIGARETTES YOU SMOKE A DAY? VERY SIMPLE, CAN BE ANSWERED -- ASKED BY ANY PERSON IN THE CLINIC AS THEY BRING THE PATIENT IN TO GET THEIR BLOOD PRESSURE DONE. THE FOLLOW-UP WOULD BE HOW LONG SINCE YOU'VE SMOKED? SO OF COURSE THIS COULD BE CORRELATED, WE ALLOW PATIENTS COUNSELING, SOME OF THE METHODS YOU'LL HEAR ABOUT FROM DR. FIORE IN A MOMENT. HERE'S OUR TASK FORCE. I REALLY THANK STEPHANIE FOR HER LEADERSHIP OW ENTIRE TEAM, OF COURSE THE HELP FROM THE AACR AS WELL. JUST TO TELL YOU A LITTLE BIT ABOUT THE EFFORTS, THERE ARE A NUMBER OF SPECIAL ISSUES COMING OUT OF ALL THE AACR JOURNALS, EACH OF THEM HAVE A SPECIFIC ARTICLE COMMEMORATING THE 50TH ANNIVERSARY OF THE SURGEON GENERAL'S REPORT WITH SOME ASPECT OF TOBACCO CONTROL, WHETHER IT BE BASIC PHYSIOLOGY AND TREATMENT TO MORE EPIDEMIOLOGICAL STUDIES. WE HAVE A COMMENTARY FROM DR. KOH AND A Q AND A WITH DR. KOH AND MITCHELL ZELLER AND EDITORIAL OVERVIEW. AT THE AACR MEETING THIS SPRING, THERE WILL BE TWO SESSIONS NOW ON TOBACCO CONTROL, NOT ON WEDNESDAY BUT IN A GOOD PART OF THE MEETING SO HOPEFULLY WILL BE WELL ATTENDED HONORING THE 50TH ANNIVERSARY WITH THIS LINEUP, AND WE APPRECIATE DR. CROYLE AND OTHERS' SUPPORT, WE'RE HOPEFULLY GOING TO BE ABLE TO HAVE MORE DISCUSSION ON THIS ISSUE AND THE FDA ITSELF WILL HAVE A SESSION AS WELL LED BY CAROLYN DRESLER. I'M NOT EVEN GOING TO TOUCH THIS. I THINK AFTER WHAT I'VE HEARD, I THINK WE HAVE AN AACR/ASCO COMMITTEE LOOKING AT THIS. AFTER READING "THE NEW YORK TIMES" ON SUNDAY, MAYBE WE SHOULD SIT IT OUT FOR A WHILE AND SEE WHAT'S GOING ON, BUT THIS IS AN INCREDIBLY CONTROVERSIAL TOPIC. MANY DON'T REALIZE WHAT AN E CIGARETTE IS AND I'M LOOKING FORWARD TO THE TALK IN A LITTLE WHILE. SO FINALLY IN MY LAST FEW MINUTES, WHAT ABOUT NEW APPROACHES TO TREATMENT IN TOBACCO-INDUCED DISEASE? EVEN IF WE'RE COMPLETELY SUCCESSFUL, MORE THAN HALF THE PEOPLE WE SEE WITH LUNG CANCER, FOR EXAMPLE, AND IT'S INCREASING, OF COURSE, ARE FORMER FOE SMOKE SMOKERS, WE THE PROGRAM AT YALE, WE TRIED TO BUILD IT AROUND SMOKING CESSATION EFFORTS. WE HAD A VERY STRONG EFFORT FROM DR. BLOCH, OUR CLINIC WHERE WE SCREEN FOR LUNG CANCER AS A TEACHABLE MOMENT, WE ACTUALLY ARE EXPLORING SEVERAL NEW METHODS FOR HOW WE CAN IMPLEMENT SMOKING CESSATION. IT'S ALSO A TIME WHERE WE CAN GET SAMPLES, BLOOD AND TISSUE, AND WE CAN LOOK AT MECHANISMS AND LOOK AT FORMER SMOKERS AND GET AN IDEA WHAT'S HAPPENING WITH THEIR IMMUNE SYSTEM, FOR EXAMPLE, WHAT'S HAPPENING WITH MICRO RNA? SO THESE ARE THE THINGS THAT WE'RE INCORPORATING INTO A FULL SERVICE LUNG CANCER PROGRAM. THE NCI SPONSORED TRIAL HAS NOW BECOME A TRIAL THAT'S FOCUSING ON KRAS LUNG CANCER. SO WHAT WE DO, COLLABORATION BETWEEN M.D. ANDERSON AND YALE, WHERE I AM NOW, IS WE ACTUALLY REMOVE THEM WHERE EVERYONE GETS A FRESH BIOPSY AS WE NOW TAKE OUT THE NEVER SMOKERS OR THE LIGHT SMOKERS WHO MIGHT HAVE MORE TREATABLE MUTATIONS AND WE'RE REALLY LOOKING AT WAYS OF TARGETING KRAS EITHER WITH IMI NAIGS OF AGENTS, OF COURSE KRAS IS A DIFFICULT -- TO TARGET, WE'RE NOW IN OUR SECOND ITERATION OF THIS LOOKING AT MORE SPECIFIC METHODS. AND THEN FINALLY, THE LAST THING I WANT TO DO IN MY LAST MINUTES IS TELL BUT A LARGE PRIVATE/PUBLIC PARTNERSHIP THAT'S REALLY FOCUSED ON SMOKING LUNG CANCER AND SQUAMOUS CELL LUNG MASTER, THE PROTOCOL KNOWN AT SWAS1400. IT'S WONDERFUL SPEAKING HERE, SOME OF THE PEOPLE INVOLVED IN SUPPORTING THIS ARE IN THE ROOM. THIS IS AN EFFORT THAT BEGAN WHEN RICK AND OTHERS AT THE FDA APPROACHED THE NCI AND ELLEN SIEGEL AT FRIENDS OF CANCER RESEARCH LOOKING FOR WAYS THAT WE COULD DEVELOP DRUGS BASED ON GENETIC PATHWAYS IN LUNG CANCER IN A WAY THAT WE COULD MOVE ALL THE WAY FROM PHASE 2 TO PHASE 3 AND MOST IMPORTANTLY TO DRUG APPROVAL. THE PARTNERS ARE SHOWN HERE. THE FNIH IS HELPING US RUN THIS, THE NCI, THE FDA, FCR. JUST THE DAY OR SO BEFORE THIS NEW NETWORK BECOMES A REALITY. AND YOU CAN SEE WE REALLY HAVE COLLABORATION FROM ALL THE DIFFERENT GROUPS TO DEVELOP A PROTOCOL IN ADVANCED LUNG CANCER. AND THE IDEA HERE IS THAT A MULTIARMED MASTER PROTOCOL THAT WOULD ALLOW US A PHASE TWO OR THREE DESIGN SO WE COULD TAKE D AND FIND THE PATIENTS FOR A SPECIFIC MOLECULAR BE ABNORMALITY, WE COULD SCREEN LARGE NUMBERS OF PATIENTS, WE'RE HOPING TO SCREEN AS MANY AS A THOUSAND PATIENTS A YEAR, WITH A SUFFICIENT HIT RATE SO EVERY PATIENT WILL GET A DRUG BASED ON THEIR OWN PARTICULAR TUMOR AND GET SAFE AND EFFECTIVE DRUGS TO PATIENT FASTER, HOPING FOR MORE RAPID APPROVALS SO THESE CAN BE AVAILABLE THROUGHOUT THE COUNTRY, NOT JUST AT THE MAJOR CENTERS. I SHOW THIS JUST AS A MEANS OF SHOWING WHY THE PROBLEM IS SO -- WE HAVE SO MUCH POSSIBILITY BUT ALSO SO MUCH FRUSTRATION. THIS IS THE HAMMERMAN PAPER IN "NATURE" THAT LOOKED AT THE WORK FOR SQUAMOUS LUNG CAB SER. THE GOOD NEWS IS YOU CAN SEE A LARGE NUMBER OF ABNORMALITIES IDENTIFIED, MANY OF THEM DRUGGABLE. BUT THE PROBLEM IS IF YOU LOOK, THE PERCENTAGES ARE QUITE SMALL. I WILL TELL YOU, GOOD LUCK IF YOU WANT TO DO A TRIAL AND YALE OR WHEREVER ELSE TO TRY TO FIND THESE 8% OR THESE 16% OF PATIENTS. YOU'LL NEVER DO IT ON YOUR OWN. IT HAS TO BE DONE THROUGH COLLABORATION WHERE YOU SCREEN A LARGE NUMBER OF PATIENTS AND THEN YOU ASSORT THE PATIENTS TO THE ARM THAT WORKS BEST, SO REALIZING SQUAMOUS LUNG CANCER IS ALMOST ALWAYS ASSOCIATED WITH SMOKING, WE'RE INCLUDING ALL THE QUESTIONS I MENTIONED TO YOU IN THIS TRIAL, AND WE'RE ALSO NOW -- WE'VE DEVELOPED THIS PROTOCOL WHERE WE ACTUALLY NOW HAVE, WITH THE SUPPORT OF MANY IN THIS ROOM, IT'S ACTUALLY GOING TO OPEN -- PHARMACEUTICAL PARTNERS HELPING TO SUPPORT THIS AND PROVIDE THE DRUGS WHERE WE ACTUALLY SCREEN A LARGE NUMBER OF PATIENTS, THEN WE ASSORT THEM TO ONE OF FOUR DIFFERENT SPECIFIC ARMS BASED ON A SPECIFIC BIOMARKER, YOU CAN SEE PI3 KINASE MUTATIONS -- RECEPTOR MUTATIONS OR AMPLIFICATION OR UPREGULATION OF CMET, THEN THERE'S AN ARM OF IMMUNOTHERAPY WHICH, BY THE WAY, LOOKS LIKE IT'S QUITE ACTIVE IN PATIENTS WHO HAVE SMOKED. YOU HAVE A NUMBER OF PHASE THREE TRIALS RUNNING IN PARALLEL SO YOU CAN FIND THE PATIENTS AND TEST THE DRUGS. SO HOPEFULLY WHAT I'VE SHOWN YOU TODAY IS A LITTLE BIT OF A WHIRLWIND. WE'RE LEARNING HOW SMOKING CAUSES CANCER, WE'RE DEVELOPING CLINICAL TRIALS TO TRY TO TREAT THIS THROUGH VERY NICELY RUN GROUPS. THIS TRIAL IS RUN BY MYSELF AND MY COLLEAGUE, BUT ONLY POSSIBLE BECAUSE OF THE NETWORK WE'VE CREATED. SO I'LL CONCLUDE AND JUST SAY THAT WE DO NEED TO FOCUS ON THE UNIQUE CONCERNS IN PATIENTS GETTING THERAPY. I THINK THAT'S SOMETHING THAT WAS IN A SURGEON GENERAL'S REPORT AND I'M VERY HAPPY WE'RE ALL WORKING TOGETHER TO NOW TRY TO ADDRESS THIS AND WHILE PRIMARY AND SECONDARY PREVENTION IS, OF COURSE, CRITICAL, WE STILL NEED TO FIND THERAPIES FOR PATIENTS WITH CANCER. THANK YOU VERY MUCH. [APPLAUSE] >> THANKS, ROY, VERY INTERESTING, VERY WIDE RANGING, LOTS OF IMPORTANT IMPLICATIONS THERE. QUESTIONS? JONATHAN? >> THANK YOU. JUST A QUICK QUESTION ON THERE. THE CLINICAL TRIALS DATA ARE VERY DISTURBING FOR THE LACK OF INFORMATION. PRESUMABLY FOR SOME OF THE TRIALS, BIOSPECIMENS EXIST, WHERE YOU MIGHT AT LEAST JUST TO UNDERSTAND THE SCOPE OF THE PROBLEM THINK ABOUT SAMPLING AND MAKING MEASUREMENTS OF COAT NEEN, HAS THERE BEEN DISCUSSION OF DOING THAT? >> IN LUNG CANCER TRIALS WHICH I KNOW BEST, IT WAS ONLY THE LAST DECADE THAT SAMPLES WERE BEING ROUTINELY COLLECTED, SO WE COULD PROBABLY GO BACK TO SOME OF THOSE. BUT NOW GOING FORWARD, I THINK IT WILL BE LESS OF A PROBLEM. THE PROBLEM WITH A LOT OF THESE TRIALS IS WHEN YOU DEVELOP YOUR NEXT -- IT WASN'T PART OF THE DIALOGUE, AND I THINK WE'RE CHANGING THAT WITH THE REPORTS YOU'VE HEARD ABOUT TODAY. >> ANY OTHER QUESTIONS? IF NOT, ROY, THANK YOU VERY MUCH. SO WE'RE GOING TO COME TO THE FINAL OF OUR PRESENTATIONS BEFORE LUNCH. JUST TO GIVE YOU A PREVIEW, WE'LL FINISH THIS UP IN ABOUT 20, 25 MINUTES, AND THEN WE'LL TAKE 45 MINUTES FOR LUNCH. WE'RE TRUNCATING THE LUNCHTIME. THAT WILL BE IN PRIVATE SESSION FOR THOSE IN THE AUDIENCE, THEN WE'LL RESUME AT 1:00. FR THE SECOND PORTION OF THE DISCUSSION ABOUT TOBACCO. NOW WE'RE GOING TO MOVE TO THE IMPORTANT TOPIC OF SMOKING CESSATION AND NEW DIRECTIONS IN RESEARCH RELATED TO SMOKING CESSATION AND WE HAVE AN EXPERT IN THAT AREA, MICHAEL FIORE. THANK YOU FOR BEING WITH US. >> THANK YOU, AND THANKS FOR THE HONOR TO SPEAK BEFORE YOU TODAY. THE SCIENTIFIC PUBLIC HEALTH AND CLINICAL RESPONSE TO THE 20TH CENTURY EPIDEMIC OF TOBACCO USE REALLY STANDS UNRIVALLED. WE'VE SEEN THIS SLIDE EARLIER TO SOME DEGREE BY DR. SAMET. BUT THIS RESPONSE AND IMPROVEMENT IN TOBACCO USE RATES IS REMARKABLE. PER CAPITA CIGARETTE CON SUMGHTS FAULCONSUMPTIONFALLING FROM ABOUT 4400 CIGARETTES PER YEAR TO 120 CIGARETTES PER YEAR TODAY, AND IN A VERY PARALLEL WAY, IN RED, WE SEE THE PREVALENCE OF TOBACCO USE FALLING FROM ABOUT 44% IN 1964 TO ABOUT 18% TODAY AND THE BOOK ENDS FOR THIS PROGRESS ARE THE TWO SURGEON GENERAL REPORTS, AND I JUST WANT TO JOIN IN COMMENDING DR. SAMET FOR THE 2014 REPORT THAT AMONG ALL OF THE OTHER THINGS THAT DOES THIS, THE FIRST THAT ACTUALLY LOOKS FORWARD AND PROVIDES A VISION FOR ENDING THE TOBACCO EPIDEMIC IN AMERICA. WHILE ENORMOUS PROGRESS, WE STILL HAVE IN AMERICA ALMOST 50 MILLION INDIVIDUALS WHO USE TOBACCO, AND IN AN EVOLUTION FROM THE PAST, TOBACCO USE RATES AS WE'VE HEARD ALREADY TODAY ARE NOW CONCENTRATED AMONG SEGMENTS OF OUR POPULATION THAT ARE THE MOST VULNERABLE, IN THE MOST UNDERSERVED, AND I THINK THEY'RE GOING TO LEAVE FOR US AN EXTRAORDINARY CHALLENGE TO TRULY END THE EPIDEMIC OF TOBACCO USE. AND FINALLY, WE HAVE EVIDENCE BASED CESSATION INTERVENTIONS THAT HAVE BEEN ESTABLISHED FOR NOW A NUMBER OF DECADES, BUT THOSE EVIDENCE-BASED STRATEGIES HAVE VERY POOR POPULATION PEN TRANTS. SO I'M GOING TO TALK ABOUT WHAT I VIEW AS AROUND THE ISSUE OF CESSATION, THREE CORY SEC CORE RESEARCH NEEDS, THREE CORZINE TISK INFORMATION NEEDS, HA WE NEED TO HAVE BETTER APPROACHES TO TREAT AND REACH UNDERSERVED POPULATIONS,, SECONDLY THAT WE NEED POPULATION-BASED CESSATION INTERVENTIONS THAT HAVE BETTER PEN TRANTS, AND FINALLY, WE NEED TO BETTER SEIZE THE HEALTHCARE VISIT AS AN UNEQUALED OPPORTUNITY TO INTERVENE WITH TOBACCO USERS. SO LET'S START WITH THE FIRST OF THESE. CESSATION INTERVENTIONS FOR THE UNDERSERVED. AS MENTIONED, RATES OF SMOKING PARTICULARLY AMONG THE POOR, THE LEAST EDUCATED, THE MENTALLY ILL, AND SUBSTANCE USERS ARE EXTRAORDINARILY HIGHER THAN OTHER PEOPLE IN OUR POPULATION, AT LEAST DOUBLE THE 18% PREVALENCE RATE. LET'S TALK ABOUT THE POOR FOR JUST A MOMENT. IN A SURVEY THAT WAS JUST PUBLISHED IN THE AMERICAN JOURNAL OF PUBLIC HEALTH, LOOKING AT FEDERALLY SUPPORTED HEALTH CENTERS, IN THOSE CENTERS, 31% OF THE ADULTS SMOKED. TON TEMPORARY TO A MISCONCEPTION THAT POOR PEOPLE DON'T WANT TO QUIT, 83% OF THOSE INDIVIDUALS REPORTED A DESIRE TO QUIT. AMONG THE MANY CHALLENGES IN REACHING THESE POPULATIONS IS IN ADDITIONAL SURVEYS OF THESE PEOPLE, WE FIND AN EXTRAORDINARY AMOUNT OF MISCONCEPTIONS ABOUT CESSATION TREATMENTS. ONE EXAMPLE IN A REPORT PUBLISHED BY CHRI CHRISTIANSON, INDIVIDUALS IN THE POOREST OF THE POOR NEIGHBORHOODS OF MILW WISCONSIN REPORTED THAT USING A NICOTINE PATCH WAS A MUCH GREATER RISK TO THEIR HEALTH THAN SMOKING FIVE TO 10 CIGARETTES PER DAY. THIS IS JUST ONE OF A NUMBER OF MISCONCEPTIONS OUT THERE THAT THE AVAILABLE EVIDENCE BASED TREATMENTS ARE NOT AFFECTED AND WE'RE NOT BRINGING THEM TO THE POPULATION WHERE THESE INDIVIDUALS RECEIVE THEIR CARE AS WELL AS RECEIVE SOCIAL SERVICES THAT PROVIDE AN EXCELLENT VENUE FOR REACHING THEM. SO IN TERMS OF NEW SCIENTIFIC DIRECTIONS, WE NEED TO THINK ABOUT WHAT SPECIFIC CESSATION INTERVENTIONS ARE EFFECTIVE BUT WHAT VENUES CAN WE BRING THESE TREATMENTS TO THEM, AND FINALLY HOW DO WE DEAL WITH THESE MISCONCEPTIONS THAT CLEARLY SERVE AS BARRIERS TO UTILIZATION OF EVIDENCE-BASED TREATMENTS. IN TERMS OF THE SECOND POPULATION, I WANT TO HIGHLIGHT THE MENTALLY ILL AS WELL AS SUBSTANCE USERS, REMARKABLY INDIVIDUALS WITH MENTAL HEALTH DIAGNOSES ACCOUNT FOR HALF OF ALL THE CIGARETTES SMOKED IN AMERICA. AND THESE INDIVIDUALS HAVE LOWER CESSATION SUCCESS RATES, REMARKABLY PEOPLE WITH MENTAL HEALTH DIAGNOSES DIANE AVERAGE DIE AN AVER AGE OF 25 YEARS EARLIER THAN THOSE WITHOUT MENTAL HEALTH DIAGNOSES, AND IN LARGE PART, THAT EARLY DEATH IS A RESULT OF THEIR TOBACCO USE, BECAUSE THEY NOT ONLY SMOKE AT HIGH RATES, IN TERMS OF THE PERCENTAGE OF SMOKING, IN SCHIZOPHRENICS, FOR EXAMPLE, IN SOME SURVEYS, UP TO 70% SMOKING, BUT THEY SMOKE A LARGE NUMBER OF CIGARETTES PER DAY. AN EXTRAORDINARY CHALLENGE, A CHALLENGE BECAUSE WE TRULY DON'T KNOW WHAT CESSATION INTERVENTIONS IN THE INTENSITY OF THOSE INTERVENTIONS ARE NEEDED FOR THESE INDIVIDUALS. THE SETTINGS IN WHICH MENTAL HEALTH PATIENTS GET MUCH OF THEIR HEALTHCARE ARE SETTINGS THAT HISTORICALLY CONDONED AND EVEN ENCOURAGED TOBACCO USE IN MANY INPATIENT WARDS, CIGARETTES WERE USED AS A REWARD FOR GOOD BEHAVIOR, AND SOME SETTINGS STILL OCCUR. THUS WE NEED TO THINK ABOUT THE SETTING IN TERMS OF NEW SCIENTIFIC DIRECTIONS, WE NEED TO THINK ABOUT THE WHOLE HEALTHCARE DELIVERY TEAM BECAUSE MANY OF THEM USE TOBACCO PRODUCTS THEMSELVES, AND FINALLY, WHAT IS THE TYPE AND DOSE OF CESSATION INTERVENTION FOR THESE INDIVIDUALS. SWITCHING GEARS FROM UNDERSERVED POPULATIONS TO POPULATION APPROACHES TO CESSATION, I'M GOING TO FOCUS IN ON TWO. THE FIRST OF WHICH IS TELEPHONE CESSATION QUIT LINES. THIS IS TRULY A SUCCESS STORY IN AMERICA. OVER THE LAST DECADE, THIS IS DEVELOPED AS AN EVIDENCE-BASED STRATEGY, WE'VE MOVED TO NOW SERVING 1% OF SMOKERS PER YEAR THROUGH TELEPHONE QUIT LINES, A HALF A MILLION SMOKERS A YEAR. EVERY STATE IN THE NATION HAS SOME SORT OF QUIT LINE. THERE'S A SINGLE ACCESS PORTAL NUMBER 1-800-QUIT-NOW. THE CHALLENGE FOR QUIT LINES IN AMERICA IS FRANKLY VERY LITTLE OF THE TOBACCO SETTLEMENT FUNDS REMAIN TO GO TO TOBACCO CONTROL EFFORTS, INCLUDING QUIT LINES. THE STATES VARY IN REMARKABLE WAYS IN TERMS OF HOW MUCH THEY DELIVER, BOTH COUNSELING THROUGH QUIT LINES AND MEDICATIONS THROUGH QUIT LINES. IN STATES LITERALLY CHANGE ON A YEAR TO YEAR BASIS, AS EVERY STATE BUDGET IS DEVELOPED, SO THAT THERE'S BOTH A PATCHWORK ACROSS THE STATE IN CONFUSION WITH IN STATES AS TO WHAT IS GOING TO BE PROVIDED. IN TERMS OF THE SCIENCE, IS THERE A WAY THAT WE CAN GET A BETTER SENSE OF GIVEN THIS REVENUE-POOR ENVIRONMENT, RESOURCE-POOR ENVIRONMENT, WHAT IS THE BEST DOSE OF QUIT LINE SERVICES BOTH FROM A COUNSELING AND A MEDICATION PERSPECTIVE, AND HOW CAN WE DELIVER THAT IN A MORE CONSISTENT WAY. THE SECOND POPULATION APPROACH THAT I WANT TO JUST MENTION BRIEFLY IN TERMS OF CESSATION IS E HEALTH AND M HEALTH APPROACHES. HERE, THE NATIONAL CANCER INSTITUTE LEADS THE NATION AND IS TRULY THE MODEL FOR THE GLOBE GLOBE. THE SUITE OF SERVICES THAT STARTED WITH SMOKEFREE.GOV NOW SERVE APPROXIMATELY 3 MILLION USERS PER YEAR. IT HAS THE GREATEST POPULATION PENETRANT OF ANY CESSATION AND TOBACCO INFORMATION RESOURCE AVAILABLE. IN TERMS OF THE SUITE OF SERVICES PROVIDED BY NCI STARTING WITH SMOKEFREE.GOV, THEY'RE LISTED ON THIS SLIDE, BUT ARE INCREASINGLY REACHING OUT TO POPULATIONS WHO WE HAVEN'T BEEN ABLE TO REACH EFFECTIVELY IN THE PAST, INCLUDING TEENS, INCLUDING SPANISH-SPEAKING SMOKERS, THIS SUMMER, A PROGRAM WILL BE LAUNCHED FOR PREGNANT WOMEN. THIS INITIATIVE BY NCI PROVIDES A FRAMEWORK FOR DELIVERING SERVICES FOR PEOPLE ACROSS THE NATION, AND I TRULY COMMEND IT. I WANT TO TURN TO THE THIRD CORE CESSATION OPPORTUNITY AND SCIENTIFIC CHALLENGE, AND THAT IS SEIZING THE HEALTHCARE VISIT. WE HAVE AN EVIDENCE BASE FOR THIS, THREE TIMES THE PUBLIC HEALTH SERVICE HAS PREPARED CLINICAL PRACTICE GUIDELINES, THE MOST RECENT IN 2008, WHERE WE REVIEWED ALMOST 9,000 SCIENTIFIC MANUSCRIPTS, WE CONDUCTED MORE THAN A HUNDRED METAANALYSES AND LAID OUT A LIST OF CLINIC-BASED RECOMMENDATIONS. THE HEALTHCARE VISIT IS UNEQUALED BECAUSE SMOKERS ARE THERE. ABOUT 80% OF SMOKERS ARE IN A PRIMARY CARE CLINIC OFFICE PER YEAR. IN A SUCCESS STORY, WE NOW DOCUMENT TOBACCO USE STATUS FOR MOST OF THEM, IN PART BY MAKING TOBACCO USE ONE OF THE VITAL SIGNS. THE CHALLENGE IS, REACH, IN DELIVERY OF SOMETHING BEYOND JUST IDENTIFYING PATIENTS AS SMOKE RS. LESS THAN HALF OF THEM LEAVE THE CLINIC VISIT RECEIVING EVIDENCE-BASED COUNSELING IN MEDICINE. DR. RIMER MADE A WONDERFUL POINT THIS MORNING THAT WE HAVE YOUNG PEOPLE, ADOLESCENTS COMING IN AND OUT OF CLINICS WITHOUT GETTING VACCINATED EVERY DAY. SIMILARLY, WITH IMPUNITY, SMOKERS COME IN AND OUT OF CLINICS WITHOUT TOBACCO USE BEING ADDRESSED AS A PRIMARY CARE CLINICIAN, I'M A GENERAL INTERNIST, I WOULD NEVER DREAM OF LETTING AN INDIVIDUAL WHO HAS A BLOOD SUGAR OF 500 OR SYSTOLIC BLOOD PRESSURE OF 300 LEAVE MY CLINICAL ENCOUN IRRESPECTIVE OF WHAT BROUGHT HER THERE THAT DAY, BUT DAY IN AND DAY OUT, WITH IMPUNITY, PATIENTS COME IN TO CLINICS AND LEAVE THOSE CLINICS WITHOUT HAVING THEIR TOBACCO USE ADDRESSED, AND WE NEED TO THINK ABOUT RESEARCH MEANS OF TAKING THE EVIDENCE AND SEEING HOW WE CAN MAXIMIZE THE WAY IT CAN CHANGE WHAT HAPPENS IN THAT CLINICAL ENCOUNTER. AND THERE ARE SOME REALLY PRIME TARGETS FOR THIS. THE ELECTRONIC HEALTH RECORD, NOT ONLY GIVES US A UNIQUE CAPACITY TO DOCUMENT BUT ALSO GIVES US A UNIQUE CAPACITY TO CHANGE CLINICAL PRACTICE, AND IN SOME WORKS SUPPORTED BY NCI AT WISCONSIN, WE'RE PARTNERING TO LOOK AT HOW WE CAN, WITHOUT INTERRUPTING WORK FLOW, BECAUSE THAT IS THE DEAL-BREAKER IN EVERY CLINIC. IF YOU INTERRUPT WORK FLOW, THEY'RE NOT GOING TO BUY IT. BUT HOW WE COULD USE IT PAR SEIZING NOT THE PHYSICIAN WHO'S OVERBURDENED BUT THE SUPPORT STAFF, THE MEDICAL ASSISTANT, TO START THE BALL ROLLING WITH AS LITTLE AS A SINGLE CLICK, TO GET TREATMENT GOING. AND OF COURSE BECAUSE OF MEANINGFUL USE IN THE MANDATES AROUND IDENTIFYING AND INTERVENING WITH TOBACCO AROUND MEANINGFUL USE, THERE ARE FINANCIAL INCENTIVES FOR HEALTH SYSTEMS AND CLINICIANS WHO TAKE ADVANTAGE OF THIS. INSTITUTIONAL CHANGES ARE ALSO SO IMPORTANT. THE DAYS OF GIVING GRAND ROUNDS AND EXPECTING TO CHANGE PRACTICE BASED UPON A LECTURE ARE OVER. WE HAVE TO CHANGE THE ARCHITECTURE OF A CLINICAL ENCOUNTER THAT MAKES IDENTIFYING AND INTERVENEING WITH SMOKE ARES THE DEFAULT, IT'S NOT AN OPTION, IT JUST HAPPENS BECAUSE OF THE ARCHITECTURE OF THAT CLINICAL ENCOUNTER. WE NEED TO LOOK AT NON-TRADITIONAL HEALTHCARE SETTINGS BECAUSE OUR HIGH PREVALENCE POPULATION WITH MENTALLY ILL, THE POOR, SUBSTANCE USERS, MAY NOT BE GOING TO THESE CLINICS. FINALLY, PERFORMANCE MEASURES ARE SO POWERFUL, THE JOINT COMMISSION HAS JUST ADOPTED A NEW INPATIENT HOSPITAL MEASURE THAT IS GOING TO MANDATE THE TOBACCO USE BE DONE. IT'S ONE OF -- THERE ARE 12 PERFORMANCE MEASURES FOR ANY JOINT APPROVAL. THE HOSPITAL GETS TO CHOOSE FOUR. IT'S STILL OPTIONAL, BUT WE'RE WORKING WITH CNS AND SOME OTHER ENTITIES TO MAKE IT ONE OF THE REQUIRED PERFORMANCE MEASURES, AND THAT WILL FUNDAMENTALLY CHANGE PRACTICE. ANOTHER REALLY IMPORTANT WAY IS HOW WE THINK ABOUT SMOKERS. SO MUCH OF OUR ATTENTION HAS FOCUSED AROUND INTERVENING WITH PEOPLE WHO ARE READY TO QUIT AT THAT CLINIC VISIT. THAT'S ONLY ABOUT 25 TO 30% OF SMOKERS. WE MEADE TO COME UP WITH EVIDENCE-BASED SCIENCE OF HOW TO MOTIVATE THOSE NOT YET READY TO QUIT, HOW TO MAINTAIN CESSATION AND THOSE WHO HAVE MADE A QUIT ATTEMPT, AND HOW DO WE RECOVER IN HELPING INDIVIDUALS WHO HAVE RELAPTSERELAPSED TO GET BACK ON THE WAGON AND QUIT AGAIN. THIS PHASE BASED MODEL IN FUNDING BY THE NCI IS ATTEMPTING TO BROADEN THE POPULATION OF SMOKERS THAT WE REACH OUT TO. I WOULD BE REMISS NOT TO ACKNOWLEDGE THAT CESSATION DOESN'T HAPPEN IN A VACUUM, POLICY WIDE POPULATION CHANGES IN PARTICULAR, TAXES, CLEAN INDOOR AIR ORDINANCES, MEDIA CAMPAIGNS LIKE TIPS AND THE NEW FDA MEDIA CAMPAIGN CREATE AN ENVIRONMENT FOR CESSATION. AND WE NEED TO SEASON AND WE NEED TO STUDY IT. WE'VE ALREADY HEARD A LITTLE BIT ABOUT THE POWERFUL AND PARTICULAR DANGERS OF COMBUSTED TOBACCO IN SOME ANALYSES RESPONSIBLE FOR UP TO 98% OF THE ILLNESS AND DEATH IN TOBACCO USE. IN THIS SLIDE WHICH WE SAW PIECES OF EARLIER TODAY BY DR. BLOCH SHOW THIS INCREDIBLE PARALLELISM BETWEEN PREVALENCE OF SMOKING AND LUNG CANCER RATES. THIS IS AMONG MEN. IT'S JUST ONE MORE MEASURE OF WHY WE NEED TO BE TARGETING PARTICULAR POPULATIONS WITH CESSATION AS WELL AS PREVENTION INTERVENTIONS. E-CIGARETTES IS GOING TO HAVE ITS OWN TOPIC THIS AFTERNOON. THE ONLY THING I WOULD MENTION ABOUT IT IS THE JURY IS TOTALLY OUT IN TERMS OF WHETHER E-CIGARETTES ARE AN EFFECTIVE CESSATION AID. THERE'VE BEEN A HANDFUL OF SMALL STUDIES, THE RESULTS ARE MIXED AND NOT PARTICULARLY IMPRESSIVE, BUT WE DO NEED TO STUDY THIS ISSUE AND SEE IF THEY CAN SERVE AS A CESSATION AID, BUT ALSO TO SERVE AS A CESSATION AID THAT DOESN'T LEAD TO DUAL USE. THE IDEA THAT I USE MY E-CIGARETTES WHILE I AM AT WORK BUT GO BACK TO SMOKING AT NIGHT WHEN I'M HOME OR AS I'M DRIVING TO AND FROM WORK, AND IN THAT WAY, POSSIBLY LEADING ME TO CONTINUE TO SMOKE RATHER THAN TO QUIT. IN A STUDY OF PREVALENCE, THIS WAS PUBLISHED IN THE AMERICAN JOURNAL OF PUBLIC HEALTH BASED ON NHIS DATA, THERE'S BEEN A REMARKABLY STEADY DECLINE IN PREVALENCE IN AMERICA OVER THE LAST 50 YEARS. IN FACT, IF YOU LOOK AT IT, IT'S A HALF OF ONE PERCENTAGE POINT PER YEAR. FROM 64 TO 2012. IF WE CONTINUE AT THAT RATE, IT'S GOING TO TAKE US UNTIL 2047 TO ELIMINATE TOBACCO USE, AND OUR CHALLENGE COLLECTIVELY, AND PARTICULARLY OUR CHALLENGE FOR CESSATION IN THE 50 MILLION INDIVIDUALS WHO USE TOBACCO, IS HOW DO WE ACCELERATE PROGRESS, ACHIEVE THIS GAIN AND NOT WAIT UNTIL THE MID PART OF THIS CENTURY? WITH THAT, I'M GOING TO STOP, AND THANK YOU FOR INVITING ME TO SPEAK. [APPLAUSE] >> MICHAEL, THAT WAS TERRIFIC. VERY INFORMATIVE, VERY MOTIVATIONAL, I WOULD SAY. IN FACT, IF YOU WANT TO GIVE UP YOUR DAY JOB, I THINK MOTIVATIONAL SPEAKER COULD BE IN YOUR FUTURE. ANY QUESTIONS OR COMMENTS? HAROLD? >> I THINK ONE COMMENT. YOUR COMMENTS ABOUT THE ROLE OF THE PHYSICIAN WHO ENCOUNTERS A SMOKER IN THE OFFICE RELATIVE TO SEEING A HYPERTENSIVE PATIENT REMINDS ME OF A COMMENT THAT BILL SELLERS MADE TO ME AT THE BREAK ABOUT TRYING TO MAKE USE OF WHAT WE CALL DEFENSIVE MEDICINE IN THE CONTEXT OF HPV VACCINATION. SO WHY NOT SET UP SOME STANDARDS THAT WOULD PUT PHYSICIANS AT RISK IF THEY DON'T VACCINATE THE ADOLESCENTS WITH HPV VACCINE, THAT DON'T REQUIRE THAT CERTAIN STEPS BE TAKEN TO ENSURE THAT PATIENTS AT LEAST ARE EXPOSED -- YOU CAN'T FORCE A PATIENT TO QUIT, BUT THAT THE MEASURES THAT WE THINK ARE ACCEPTED AND APPROPRIATE ARE DELIVERED TO THAT PATIENT AND THE PATIENT SIGNS A STATEMENT SAYING THAT MY SMOKING HABIT WAS RECOGNIZED, I HAVE HEARD THE FOLLOWING THINGS, I DECLINE TO PURSUE THEM, AS A WAY OF GUARANTEEING THAT PATIENTS WOULD NOT LATER ON SUE THEIR PHYSICIANS FOR FAILING TO PROTECT THEM AGAINST CERVICAL OR OR OWE PHARYNGEAL CANCER OR TO PROTECT THEM AGAINS SUITS FOR HAVING DEVELOPED LUNG CANCER AND NOT STOP SMOKING? >> POINT TAKEN. SOME HAVE SAID THAT IT'S GOING TO TAKE A COUPLE LAWSUITS THAT PARTICULARLY ADDRESS THE ISSUE OF A PERSON WHO DEVELOPS LUNG CANCER OR ANOTHER OUTCOME AND WASN'T ADVISED AND COUNSELED BY THEIR PHYSICIAN TO REALLY MOVE THE NEEDLE, BUT GOOD POINT. >> CAN IT BE DONE WITHOUT HAVING TO HAVE A SERIES OF CASES THAT -- >> EXACTLY. >> YOU CAN SET LAWS OR GUIDELINES -- >> JENNIFER. >> TO THAT POINT, MICHAEL MADE A VERY POWERFUL POINT. I AGREE WITH YOU, MOTIVATIONAL SPEAKER. MEANINGFUL USE HAS ALREADY STARTED THAT PROCESS. SO OUR CANCER CENTER SITS IN THE BELT BUCKLE OF THAT RED AND THERE IS NOT AN INTAKE FORM IN ANY CLINIC THAT DOES NOT ASK ABOUT TOBACCO USAGE, HOW MANY YEARS, HOW MANY CIGARETTES, HAVE YOU BEEN COUNSELED, HAVE YOU BEEN SCREENED. THAT'S ALREADY PART OF THE PROCESS. AS WELL AS INPATIENT AND NOW OUTPATIENT TRACK AND TREAT. BECAUSE MEANINGFUL USE RIGHT NOW, MOST ALL OF THOSE HEALTHCARE PROVIDERS ARE NOT GETTING FULL REIMBURSEMENT FROM CNS WHO AREN'T ADDRESSING THAT ISSUE. SO IT IS REALLY BEING ENFORCED FEDERALLY NOW. >> JUST TO ADD ONE POINT I DID MAKE, THAT MEANINGFUL USE IS SO POWERFUL. THE AFFORDABLE CARE ACT HAS OF COURSE INCREDIBLY SPECIFIC LANGUAGE THAT ALL PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS A AND B MUST BE COVERED WITHOUT CO-PAY, WITHOUT BARRIERS, WITHOUT LIMITS. ONE CHALLENGE IS THAT IN THE GUIDANCE RECEIVED FROM CMS THUS FAR, THERE HAVE NOT BEEN SPECIFICITY TO HEALTH PLANS IN TERMS OF WHAT THE NATURE OF COVERAGE SHOULD BE, AND THERE'S BEEN SOME MOVEMENT ON THIS RECENTLY, HHS HAS TAKEN THIS ON, AND I SUSPECT WITHIN JUST A FEW MONTHS, WE'RE GOING TO GET NEW SPECIFIC GUIDANCE ON THE NATURE OF THE COUNSELING AND THE MEDICATIONS THAT ARE GOING TO NEED TO BE COVERED TO ENSURE, AND ONCE THAT HAPPENS, THAT MEANS THAT EVERY HEALTH PLAN WILL COVER TOBACCO USE TREATMENT, AND IT WILL BE A GAME CHANGER FOR THIS TOPIC. >> SO MICHAEL, MAYBE I'LL FINISH WITH TWO QUESTIONS. FIRSTLY, YOU DIDN'T MENTION MEDICAL IP INTERVENTIONS FOR CESSATION, VACCINATIONS, FOR EXAMPLE. I WONDER IF YOU CAN COMMENT ON THAT. I KNOW OF EFFORTS AFOOT TO LITERALLY ATTEMPT TO VACCINATE AGAINST NICOTINE ADDICTION. OR NICOTINE EXPOSURE, I SHOULD SAY. SO IF YOU COULD COMMENT ON THAT. AND MY SECOND QUESTION, I WAS WAITING TO HEAR ABOUT THE ROLE OF THE ACS IN ALL OF THIS. AND I DIDN'T HERE MENTIONED ONCE BY ANY OF YOU. SO IF YOU CAN TALK ABOUT THE INVOLVEMENT AND COORDINATION WITH ACS CESSATION EFFORTS SPECIFICALLY. >> SO THE ISSUE OF VACCINATION, A REALLY FASCINATING TOPIC. THERE WAS A LARGE COOPERATIVE STUDY FUNDED BY NIDA AND A COMPANY CALLED NABI THAT DEVELOPED A NICOTINE VACCINE. THE NOTION IS THAT YOU GET THE VACCINE, YOU DEVELOP A PROTEIN THAT BINDS NICOTINE AND THAT PROTEIN NICOTINE BOUND COMPOUND IS TOO BIG TO PASS THROUGH THE BLOOD-BRAIN BARRIER. THUS YOU DON'T GET ANY REINFORCING EFFECTS OF SMOKING. T STUDY WAS DONE ACROSS MULTIPLE CENTERS ACROSS THE NATION AND HAD ZERO EFFECTIVENESS. THERE ARE A COUPLE OTHER COMPANIES THAT ARE PURSUING THIS, NONE YET IN THE LARGE SCALE CLINICAL TRIAL PHASE. IT'S VERY APPEALING CONCEPTUALLY, OPERATIONALLY IT'S NOT YET BEEN EFFECTIVE. TO THE ISSUE OF ACS, I VIEW ACS AS A REALLY IMPORTANT PARTNER WHO HAS DONE AN ENORMOUS AMOUNT, BEFORE IT WAS FASHIONABLE TO BE PROMOTING CESSATION AND EVEN AGAINST TOBACCO USE. THEY STARTED THE GREAT AMERICAN SMOKEOUT AND THAT CONTINUES TO BE AN ENGINE. I'M SURE ACS, LIKE SOME ENTIT IS STRUGGLING WITH FINANCIAL CHALLENGES, BUT I -- AND I DON'T THINK THAT THE NON-PROFIT FRANKLY CAN HAVE A DRAMATIC EFFECT. I THINK WHERE THE MONEY IS IS SYSTEM LEVEL CHANGES. WE HAVE INSTITUTIONS THAT TOUCH SMOKERS EVERY DAY. THOSE INSTITUTIONS ARE LETTING THOSE SMOKERS GO WITHOUT INTERVENING. THEY'VE GOT SO MUCH MORE POTENTIAL, HOW DO WE MAKE THAT STICKY, HOW DO WE MAKE THAT SMOKER GET AT LEAST SOMETHING. ACS IS IMPORTANT, AND I REALLY THINK IT'S A WONDERFUL ORGANIZATION BUT THEY'RE NOT GOING TO BE ABLE TO DO IT BY ITSELF. >> KEVIN, PLEASE, ONE MORE. >> ACS HAS ACTUALLY FOCUSED A LOT OF ITS EFFORT IN A DIFFERENT DIRECTION IN RECENT YEARS. IT'S MOVED THROUGH ITS 501C4 WORKING WITH STATE LEGISLATURES TO INCREASE TOBACCO TAXES, REALLY ONE OF THE MOST EFFECTIVE ANTITOBACCO EFFORTS IS INCREASING TAXES ESPECIALLY FOR YOUNG SMOKERS, SO ACS HAS REALLY FOCUSED A LOT OF EFFORTS IN THE LAST COUPLE OF YEARS WORKING WITH INDIVIDUAL STATE LEGISLATURES TO PASS INCREASED TOBACCO TAXES AT THE STATE LEVEL. >> MICHAEL AND ALL OF THE SPEAKERS FROM THIS MORNING, LET'S GIVE THEM ANOTHER ROUND OF APPLAUSE. SO LET'S NOW BREAK FOR LUNCH. NCAB MEMBERS, YOU HAVE TO GO OUT TO THE BREAK AREA, PAY YOUR $10.25, GUESTS, IF YOU CAN CLEAR THE ROOM WILL RESUME AT 1:00. LET'S SETTLE DOWN AND GET STARTED. SO WE'RE GOING TO CONTINUE OUR DISCUSSION ON THE BROAD TOPIC OF TOBACCO, TOBACCO CONTROL. THIS SUBJECT WE'RE ABOUT TO HEAR HAS BEEN REFERENCED BY SEVERAL SPEAKERS ALREADY. MICHELLE, ARE YOU GOING TO CHAIR THIS PORTION OF THIS SESSION? >> YES, ACTUALLY WHAT I'M GOING TO DO IS BRIEFLY INTRODUCE EACH OF THE SPEAKERS SO WE CAN RUN RIGHT THROUGH IF WE DON'T MIND. IN A MOMENT I'M DEVELOPING TO INTRODUCE DR. CLARK, PROFESSOR UNIVERSITY OF MARYLAND COLLEGE PARK. SHE IS A PRINCIPLE INVESTIGATOR OF ONE OF THE 14 NIH FDA FUNDED CENTERS OF REGULATORY SCIENCE KNOWN AS PCORS. HER RESEARCH INCLUDES CHARACTERIZATION AND ABUSE LIABILITY OF MULTIPLE FORMS OF TOBACCO PRODUCTS AND SHE WILL BE SPEAKING TO US IN A MOMENT ON E-CIGARETTES. FOLLOWING DR. CLARK I'M DELIGHTED TO INTRODUCE DR. TOM GLYNN, NCI ALUMNIST. DIRECTOR OF CANCER SCIENCE AND TRENDS AND DIRECTOR OF INTERNATIONAL CANCER CONTROL AT THE AMERICAN CANCER SOCIETY. AND HE IS A LEADING NATIONAL AND GLOBAL EXPERT IN TOBACCO CONTROL. FOLLOWING HIM WILL BE OUR OWN DR. TED TRIMBLE, FOUNDING DIRECTOR OF NCI CENTER FOR GLOBAL HEALTH AND INTERNATIONALLY RECOGNIZED EXPERT IN THE BRANCH AND SCREENING TREATMENT AND SYMPTOM MANAGEMENT OF GYNOCOLOGIC CANCERS. OUR FINAL SPEAKER WILL BE MR. MITCH ZELLER. IN A 1990s MR. ZELLER WORKED UNDER FDA COMMISSIONER DAVID KESSLER WHERE HE OVER SAW THE INVESTIGATION OF TOBACCO AND FIRST FDA ROUND OF REGULATION NONNEWS THE USE RULE. IN 2000 THE SUPREME COURT OVERTURNED FDA ASSERTION OF JURISDICTION SO THAT ENDED THE FIRST PHASE OF MITCH'S FDA WORK BUT AFTER THE PASSAGE OF FAMILY SMOKING AND PREVENT FAMILY SMOKING AND TOBACCO CONTROL ACT, WHICH GAVE FDA AUTHORITY AND THAT'S THE TOPIC OF HIS TALK, MITCH IS NOW RETURNED TO BE DIRECTOR OF FDA CENTER FOR TOBACCO PRODUCTS AND NOW INSTEAD OF DIRECTING A SMALL BAND OF HIGHLY OVERWORKED FOLKS IN THE 1990s, HE'S DIRECTING MANY HUNDREDS OF HIGHLY OVERWORKED FOLKS NOW. SO I WILL TURN THE MIC OVER TO -- >> I'LL SEND THESE AROUND FOR YOU GUYS TO TAKE A LOOK AT. SHOW AND TELL. >> AS YOU CAN MANAGE THIS IS A VERY POPULAR DISCUSSION RIGHT NOW ON TOBACCO CONTROL COMMUNITIES. THESE PRODUCTS WERE FIRST INTRODUCED TO THE MARKET ABOUT 2009, THEY JUST STARTEDDED TO REALLY TAKE HOLD. AND THEY WERE ADVERTISED AS YOU CAN SMOKE ANYWHERE. ESSENTIALLY OVERCOMING CLEAN INDOOR AIR LAWS, THAT RAISED CONTROVERSY OFF THE BAT. BECAUSE IT TENDS TO MAKE BRIDGE PRODUCTS TO KEEP PEOPLE SMOKING WHO OTHERWISE MAY HAVE STOPPED. BEEN ENDORSED VERY LOUDLY AND CHEERILY BY CELEBRITIES. THERE'S 200 MAKERS OF THESE, MOST SMALL PEOPLE. THE INDEPENDENT MARKET IS LORILLARD RJ REYNOLDS AND BRITISH AMERICAN TOBACCO COMPANIES. WITH THEIR DISTRIBUTION SYSTEMS THEY DO A PHENOMENAL JOB ORGANIZING USERS AND GETTING OUT AND GETTING THE PRODUCT INTO EVERY STORE IN TOWN. THEY'RE USING THE SAME POLITICAL AND PUBLIC RELATIONS STAT T INJURIES AS THEY DID FOR SELLING CIGARETTES. THEY'RE ORGANIZING USERS. THAT'S BECOME A VERY IMPORTANT PART OF THE E-CIGARETTE MOVEMENT IS ORGANIZATION OF USERS INTO BUILDING BLOCKS ESSENTIALLY AND INFLUENTIAL POLITICAL FOLKS. THEY'RE NOT LIKELY TO ALLOW TOTAL CANNIBALIZATION OF CIGARETTE SELL SALES, I DON'T THINK THEY HAVE ANYTHING IN MIND TO USE E-CIGARETTES TO HELP PEOPLE STOP SMOKING. THERE'S FIVE PARTS TO THE DELIVERY SYSTEM, WE CALL THESE ENDS. ELECTRONIC NICOTINE DELIVERY SYSTEMS. BACK AND FORTH WITHER ESIGNATURES BECAUSE PEOPLE ARE COMFORTABLE WITH THAT. THE HOUSING, A TIP SUCKED ON BY USER A BATTERY THAT'S, AN ATOMIZER HEAT THE LIQUID AND VAPORIZES AND THE TANK THAT HOLDS THE eJUICE, THAT'S THE STUFF IN THERE THAT IS CONTAINING THE FLAVORS AND OTHER ADDITIVES AND NICOTINE. THE eIOUS CONTAINS PROPYLENE GLYCOL AND/OR VEGETABLE GLYCEROL. NICOTINE ANYWHERE FROM NONE TO 36-MILLIGRAMS PER MILLILITER, TREMENDOUSLY WIDE RANGE. FLAVORINGS ARE VERY IMPORTANT ESPECIALLY WITH THE LATER GENERATIONS OF E-CIGARETTES. AND ADDITIVE IT ISES TO TRY TO MIMIC THAT THROAT GRAB THAT SMOKERS NEED, THAT IS PART OF THE THROAT GRAB, THE FEELING OF THE NERVE SYSTEM WHEN YOU SMOKE A CIGARETTE, WHEN THE NICOTINE HITS THERE AND YOU START TO ASSOCIATE THAT WITH THROAT GRAB NICOTINE, THROAT GRAB NICOTINE ANDORRANSS FOR OF ITS OWN SO TRYING TO REPRODUCE THAT, SO FAR LOTS OF SUCCESS IN E-CIGARETTES. THE FIRST GENERATION, ONES I SAID AROUND I SENT YOU ONE OF IN THIS, THEY CALLED CIG ALIKES. THEY LOOK LIKE CIGARETTES. THEY MIMIC CIGARETTES. THERE'S TWO, DISPOSABLE, RECHARGEABLE WITH PRE-FILLED CARTRIDGES SO YOU BUY MORE TO PUT IN. MOST RESEARCH ON E-CIGARETTES IS DONE USING THE FIRST GENERATION DEVICES. THEY HAVE EVOLVE SOD QUICKLY IT'S HARD TO GEAR UP AND TAKE ON A NEW PRODUCT, NEW DEVICE TO TEST. TEST. SECOND GENERATION ARE REFILLABLE, MORE DECURIATIVE, NOT SUPPOSED THE TO LOOK LIKE CIGARETTES. AND P BLUE IS THE COMPANY GOING IN THIS DIRECTION TRYING TO SAY WE DON'T WANT TO LOOK LIKE, WE WANT TO BE DIFFERENT, UNIQUE AND ATTRACTIVE TO YOUNG FOLKS. ADVANCED PERSONAL VAPORIZERS. >> PERSONALIZED VAPORIZERS. >> AND THEY GIVE CONTROL OVER THE VOLTAGE OF BATTERY. THAT'S A REALLY IMPORTANT COMPONENT BECAUSE IF YOU CONTROL THE VOLTAGE OF BATTERY YOU ALSO CONTROL THE AMOUNT OF NICOTINE YOU'RE GOING TO GET TO THAT E-CIGARETTE. I SENT ONE OF THOSE AROUND, THEY'RE VERY BIZARRE, I HAVEN'T QUITE FIGURED HOW TO USE THAT YET. I HAVE TO GO BACK TO THE VAPE SHOP AND GET MORE LESSONS. THIS ONE IS REALLY INTRIGUING BECAUSE AS RESEARCHERS WE WANTED TO MEASURE SMOKING TOPOGRAPHY WITH E-CIGARETTES AND THE STANDARD EQUIPMENT DOESN'T WORK, IT DOESN'T CAPTURE THE FLOW. BUT THIS PARTICULAR ADVANCE THE MOD THIRD GENERATION HAVE ACTUALLY BUILT A SMOKE PUFF TOPOGRAPHY ANALYZER INTO IT AND IT CAN DO ALL THESE THINGS BY HOOKING UP TO YOUR COMPUTER. STAND BY SETTING PUFF SETTING, SHOW INHALING, AND DEFINITELY THERE ARE TWO THINGS THAT ARE REALLY IMPORTANT. ONE IS THE VARIABLE VOLTAGE YOU CAN GET WHATEVER YOU WANT OUT OF IT AND THE OTHER ONE IS A BATTERY OVERHEATING INDICATOR. THAT'S IMPORTANT BECAUSE THERE'S SEVERAL EPISODES OF THE CIG ALIKE IT IS FIRST GENERATION EXPLODING AS PEOPLE LEARN TO TRY TO PUFF AND PUFF AND PUFF AND HEAT UP THE BATTERY SO MUCH IT EXPLODES AND THAT'S NOT NICE. WHO IS SCRAPING? YOUNGER, HIGHER INCOME BETTER EDUCATED, BOTH GENDERS, LOOKS LIKE THERE'S NO GENDER BIAS HERE. A LOT OF DUAL USERS, THAT'S WHAT MOST IS RIGHT NOW, PEOPLE WHO SMOKE CIGARETTES AND THEY ALSO SMOKE OR VAPE CIGARETTES. I ASKED A QUESTION, AS YOU HAVE BEEN TALKING TO THE FOLKS COMING IN MY LABORATORY WHO ARE E-CIGARETTE USERS, THERE SEEMS TO BE A SUBCULTURE OF USERS THAT COULD BE VERY IMPORTANT IN ANY POLICY DETERMINATION. NAY BELIEVE THEY SAVE LIVES OF SMOKERS OF ANALOG CIGARETTES, THE KIND YOU LIGHT, THEY KISS STAIN CIG ALIKES THEY THINK IF YOU ARE SMOKING YOU'RE AN AMTURE E-CIGARETTE USER. THEY'RE OBSESSED WITH THE CUSTOMIZABLE TECHNOLOGY. THEY TRICK OUT THEIR PIECES WITH NEWEST UPGRADES, MODS PERSONAL VAPOR PIZERS AND THEY LOOK PRETTY WE SHOULD AFTER A WHILE. THEN THEY SPEND THOUSANDS OF DOLLARS A YEAR ON THEIR HOBBY. JUST USING eING IS GETS IS LESS EXPENSIVE THAN USING CIGARETTES. IF IT'S A CIG ALIKE BUT SOON AS YOU GET HIGHER ORDER CULTURE YOU CAN DROP A LOT OF MONEY INTO THE PROCESS. HERE ARE A COUPLE OF THIRD GENERATION MODIFIED PERSONALIZED VAPES. HE'S ACTUALLY WEARING IT AROUND HISTAMIC LIKE JEWELRY. -- HIS NECK LIKE JEWELRY. THERE'S VA PPE TESTS ALL OVER THE COUNTRY. THESE ARE HIGHLY SPONSORED MULTI-DAY EVENTS. THE DC VAPE FEST THAT JUST TOOK PLACE HAD 39 SPONSORS. THAT'S HOW MANY PEOPLE THERE ARE OUT THERE WITH A MONETARY INVESTMENT IN GETTING PEOPLE TO SMOKE MORE, PARTICULARLY APPEALING TO THE REAL SUBCULTURE PEOPLE OF VAPING. WHEN I WENT TO THE VAPE STORE TO GET THAT SO I CAN GIVE YOU A CHANCE TO SEE WHAT THEY LOOK LIKE, IT WAS QUITE EXPERIENCE GOING IN THERE. I'M GOING BACK BECAUSE IT'S A STRANGE GROUP OF PEOPLE. AND THEY'RE SO INTENSE ON TALKING ABOUT WHAT THEY HAVE DONE TO CUSTOMIZE THEIR E-CIGARETTES. I'M OF THIS QUOTE FROM SIMON CHAPMAN, NO ONE HAS EVER HEARD OF A NICOTINE PATCH CLUB WHERE PEOPLE ARE ADDICTED TO THESE THINGS SAY THAT'S ALL GET TOGETHER I'M A PATCH USER, LET'S HAVE A CLUB. WE HAVE GOT SOMETHING IN COMMON. BUT WHAT HAS HAPPENED BECAUSE E-CIGARETTE USERS HAVE GATHERED INTO THESE CLUBS, AND HAVE BEEN FIGHTING REGULATIONS LIKE CRAZY WITH ASSISTANCE FROM THE BUYERS. (OFF MIC) VAIN >> IS THERE EVIDENCE HIGHER END DEVICES LIKE DETACHABLE CHAMBERS ARE USED TO DELIVER THINGS OTHER THAN NICOTINE? >> IT'S NOT AS CONVENIENT AS USING HOOKAS TO DELIVER MARIJUANA. BUT THERE SOME HAVE BEEN ADAPTED TO HEAT MARIJUANA. I THINK IT'S A WASTE OF MARIJUANA. BUT I HAVEN'T DONE A STUDY HOW MUCH LONGER IT MIGHT LAST TO USE IT THAT WAY. >> YOU -- >> THESE ARE VERY POWERFUL SPECIAL INTEREST GROUPS NOW. >> YOU HAVEN'T BEEN TO SAN FRANCISCO. IN SAN FRANCISCO A LOT OF PEOPLE SMOKE MARIJUANA WITH THESE EDEVICES. BECAUSE YOU DON'T HAVE MATCHES, THEY DON'T HAVE PAPER, ZIG ZAGS AND STUFF. AND IT'S -- AND YOU BURN LESS MARIJUANA. BECAUSE YOU DON'T -- IT'S SO -- PEOPLE TALK ABOUT THIS, IT IS USED FOR ALL KINDS -- ANYTHING YOU SMOKE. >> IT MAYBE SLOWER TO COME TO OUR END OF THE COUNTRY, TO START OUT OVER ON THE WEST COAST. HOW EFFECTIVE ARE THEY? NICOTINE DELIVERY CRAVING WITHDRAWAL OR SMOKING CESSATION? THIS IS THE P-3 COMPONENT OF ERP THAT WE DO EEGs OF PEOPLE'S HEADS WHEN USING THE MACHINES AND THE DIFFERENCE HERE IS OWN BRAND CIGARETTES THE DIFFERENCE BEFORE AN AFTER SMOKING AND ENDS WITH NICOTINE, THERE'S NOT A LOT OF DIFFERENCE IN THOSE TWO. THERE'S MORE EFFECT WITH OWN BRAND CIGARETTES THAN WITH THE E-CIGARETTE. TWO COMPONENTS, OWN BRAND CIGARETTES IS DEFINITE THERE. THE ENDS WITH THE NICOTINE IS MORE PRONOUNCE WITH THE THE N-2 COMPONENT THAN P-3. WHAT ABOUT DELIVERY OF NICOTINE? TOMMIZEBERG DID A STUDY IN 2010, PUBLISHED IN 2010, THAT'S A PROBLEM, THIS IS EARLY IN THE RESEARCH CYCLE COMPARING TOBACCO SMOKING AND P ONLY TOBACCO SMOKING CAUSED INCREASE IN BLOOD NICOTINE LEVELS. BE LON FOUND ENDS REACH MAXIMUM BLOOD LEVEL OF 1.2-GRAMS MILLILITER IN 20 MINUTES THAT'S LOW LEVEL. THE PROBLEM WITH THAT, WE ARE USING EYE NEOUSERS, WE HAVE TO GET A DEFINITION OF A MORE EXPERIENCED USER AND START ENROLLING THEM IN OUR TRIES BECAUSE THEY LEARN HOW TO GET OUT OF E-CIGARETTE WHAT THEY NEED TO GET OUT OF IT. MAYBE FIRST GENERATION DEVICES WERE NOT EFFECTIVE, COULDN'T CONTROL BATTERY VOLTAGE FOR INSTANCE. SO WHEN TOM WENT AND DID ANOTHER STUDY PUBLISHED 2013 USERS USING THEIR OWN DECEMBER VICES THEN THEY HAD A -- DEVICES THEY HAD AN EFFECTIVE NICOTINE DELIVERY WITH IF HE COULD GENERATION. NOBODY TESTED THIRD GENERATION YET. (INDISCERNIBLE) EFFECTIVE NICOTINE DELIVERY WITH FIRST GENERATION DEVICE IN REGULAR USERS, NOT NAIVE USERS. SO WHAT ABOUT SMOKING CESSATION? IT LOOKS LIKE IT'S PROBABLY ALLEVIATING CRAVINGS SOMEWHAT. IN OUR LABORATORY DEFINITELY THOUGH THEY'RE NAIVE USERS THEY ARE HAVE A REDUCTION IN CRAVING. RANDOMIZED CLINICAL STUDIES SUGGEST CESSATION MAKES IT COMPARABLE TO NRT. SO THAT TELLS US THIS HAS POTENTIAL TO POSSIBLY BE ONE MORE THING IN THE TOOL KIT OF CESSATION DEVICES. ALL THESE TRIALS WERE DONE USING CIS ALIKES, THEY'RE JUST REGULARTIVELY NAIVE USER. WHAT MAYBE THE RESPECT OF REGULATION EVENTS, I WOULD L LOVE TO HEAR FROM MITCH ON THIS. IT LOOKS LIKE ONCE FDA TAKES AUTHORITY OVER ELECTRONIC NICOTINE DELIVERY SYSTEMS, IN ORDER TO DO CESSATION TRIAL RANDOMIZED CLINICAL TRIAL WE HAVE TO HAVE AN IND. INVESTIGATIONAL NEW DRUG APPLICATION. IF WE DID THAT, THAT ESSENTIALLY RULES OUT ANY I DID P PENDENT PERSON -- INDEPENDENT PERSON OR ORGANIZATION FROM BEING ABLE TO DO A TRIAL FOR CESSATION. CAN'T BE DONE. WE DON'T HAVE FACILITIES TO DO IT, WE DON'T HAVE CONTROL OVER MANUFACTURING PROCESS THAT YOU WOULD IF YOU WERE A SPONSOR IN THE TRIAL. LIKE NEW DRUGS. SO WHAT'S THE CONTROVERSY ABOUT? AS I JUST BEEN LISTENING TO PEOPLE, SAYING THERE IS NO CONTROVERSY, SOME SAYING NEW THINGS ABOUT THE CONTROVERSY, THE BIGGEST PROBLEM RENORMALIZING SMOKING. THIS TREMENDOUS TRIUMPH MAKING CIGARETTE SMOKING NOT A NORMAL PART OF LIFE, NOT SOMETHING YOU'RE AUTOMATICALLY GOING TO DO WHEN YOU REACH YOUR 16th BIRTHDAY, COULD BE REVERSED THROUGH THIS. AND MARKETING ADS FOR THESE ARE BACK ON TELEVISION AND THEY'RE MARKETED THE SAME WAY OLD FASHIONED CIGARETTE ADS WERE, A GLAMOROUS OFTEN TIME SCENES IN BARS, A LOT OF WOMEN IN THE ADS SO IT LOOKS VERY MUCH LIKE OLD TIME CIGARETTE ADVERTISING. YOUTH ARE VERY RAPIDLY ADOPTING THESE PRODUCTS AND DUAL USE AMONG USE IS VERY COMMON. MORE LIKELY TO USE E-CIGARETTES IF HEAVY SMOKERS THAN LIGHT SMOKERS. THAT DOESN'T TELL US MUCH ABOUT THE ROLE OF THESE THINGS IN NON-DAILY SMOKERS. THAT'S AN INTERESTING THING TO LOOK AT. IT'S INTERESTING TO LOOK AT NON-DAILY SMOKERS ANYWAY BECAUSE THEY'RE ADDICTED, THEY DON'T SMOKE EVERY DAY AND WITH WE DON'T KNOW HOW THAT FITS WITH THE USE OF E-CIGARETTES. THE TEMPORAL RELATIONSHIP BETWEEN USE OF AND TOBACCO CIGARETTES IS NOT KNOWN. WE DON'T HAVE GOOD EVIDENCE OF WHETHER IT'S A GATEWAY PRODUCT AND THEY GET USED TO THE NICOTINE LEVEL AND DEMAND MORE NICOTINE AND THEY MOVE UP TO REGULAR CIGARETTES, WE DON'T KNOW THAT. WE ALSO DON'T KNOW IF THEY STARTED WITH REGULAR SIGNATURE DEGREES, FOUND IT INCONVENIENT, TOO MANY RULES AGAINST USING THEM, AND SWITCHED OVER TO E-CIGARETTES SO THAT'S ANOTHER THING TO HOPE TO LEARN ABOUT SOON. THIS MAYBE ANOTHER CHOICE TO PUTTING AMONG SOME CIGARETTE SMOKERS. BUNCH OF PEOPLE BANDED TOGETHER WHO STOPPED REGULAR CIGARETTE USE BECAUSE OF E-CIGARETTES AND THEY GO ON THE NEWS CHANNELS AND SAY DON'T TAKE MY E-CIGARETTES AWAY. THIS IS THE ONLY THING SAVING MY LIFE. CERTAINLY PATCH DOESN'T WORK FOR EVERYBODY, EVERYTHING WE HAVE DOESN'T WORK FOR EVERYBODY, WE NEED TO DO A BETTER JOB FIGURING OUT WHAT SMOKER BEST MATCHED WITH WHAT PRODUCT TO HELP THEM THROUGH. MAYBE ASSOCIATEDDED WITH LOWER ODDS OF QUITTING I WANT COULD BE A BRIDGE PRODUCT THAT KEEPS PEOPLE SMOKING THAT MIGHT HAVE QUIT OTHERWISE BECAUSE OF INCONVENIENCE. IENT WENT ACROSS CAMPUS TO GET A WIDGET MADE BY A SHOP IN THE PHYSICS BUILDING AND HERE IS A STUDENT WITH HIS E-CIGARETTE PLUGGED INTO HIS COMPUTER SMOKING BECAUSE IT WAS RAINING OUTSIDE AND HE DIDN'T WANT TO GO OUTSIDE IN THE SMOKE AREA. THE DISEASE RISK IS MOMENT DECEMBERLY EFFECTED IN DUAL USER, IT'S NOT LIKELY ABLE TO DROP THE DISEASE RISK BECAUSE SOMEBODY SOMETIMES SMOKING E-CIGARETTES REPLACING FOR -- AS REPLACEMENT FOR REGULAR CIGARETTES. IF PASSIVE EXPOSURE RESULTS IN THE SAME NICOTINE LEVELS OF PASSIVE SMOKERS. SO WE DO KNOW THAT PEOPLE AROUND THESE PROBABLY CHILDREN AN DOGS LIKE IT IS WITH CIGARETTES PRIMARILY, ARE GETTING MEASURABLE COTININE LEVELS BUT WE DON'T KNOW MUCH ELSE ABOUT THAT. WE DON'T EVEN KNOW WHETHER THESE DELIVER ANYTHING TO THE LUNGS. I WANT TO RADIO LABEL NICOTINE AND DO A PET SCAN AND SEE WHETHER WHERE IT'S DEPOSITED. IT'S THROAT, BUTCAL THROAT AND MAYBE VERY HIGH RESPIRATORY. I DON'T THINK ANYTHING GETS TO THE LUNGS WITH THESE. THAT'S MY OWN OPINION. BASED ON NO INFORMATION. THOUGH EVERYBODY IS WILLING TO DO SOMETHING AND TAKING A POSITION AND EVERYBODY IS SAYING WE GOT TO GET SOME LEGISLATION ON THIS REGULATION ON THIS, WE DON'T KNOW ENOUGH. I HATE TO EVER, EVER END A TALK LIKE THAT. WE NEED MORE RESEARCH. BUT WHEN YOU THINK ABOUT THESE, INTRODUCE AROUND 2009, THEY FIRST START HITTING THE SCENE. MY FIRST NIH AND NIDA AWARD TO STUDY THEM WASN'T UNTIL 2012. THAT IS HOW FAST EVERYTHING IS MOVING YET THE INDUSTRY IS MOVING LEAPS AN BOUNDS TO CHANGE PRODUCTS AND MAKE MORE EFFECTIVE AND GET CONSUMERS TO USE THEM THE WAY THEY WANT TO GET THEM AND P TO GET BETTER CONSUMER, VERY DEDICATED CONSUMERS. THANK YOU VERY MUCH. [APPLAUSE] >> WE HAVE TIME FOR A FEW YES, SIR. >> MICROPHONE PLEASE. >> ANY SENSE OF THE NUMBER OF ACTIVE USERS AND HOW THAT'S CHANGING OVER TIME? >> JUST BETWEEN 2010 AND 2012 RATES HAVE MORE THAN DOUBLED. THEY DOUBLED AMONG THE ADULT TOBACCO USERS AS WELL AS AMONG KIDS. AMONG KIDS THAT'S STILL PRETTY LOW. BUT IT'S JUST A TREND, KIND OF A SCARY ONE. SOMEBODY AT LUNCH SAID -- I FORGET WHO WAS MENTIONED THEY'RE WONDERING IF THIS IS A PASSING FAD. IS THIS -- WELL, H HOKKA IS A PASSING FAD BUT IT'S STILL HERE TO SAY AND THE SHOPS ARE UP AND VAPE SHOPS ARE OPENING UP TOGETHER SO THE CULT CAN GET TOGETHER AND TALK EXPERIENCES. SO IT'S HARD TO KNOW HOW DEEPLY THAT IS SETTING INTO THE POPULATION. I WISH I KNEW THAT. >> QUICKLY FOLLOW-UP, HOW MANY ATTENDEES AT THE DC VAPE FEST? >> I WISH I HAD KNOWN, I WOULD HAVE GONE. >> A HUNDRED, A THOUSAND? >> I HAVE NO CLUE. ONE COMING UP IN LAS VEGAS THAT I MIGHT HAVE TO TAKE A TRIP OUT TO. I KNOW THE PERSON WHO RUNS THEN, A PERSON WITH A I MORPHONE UP FRONT, THEY WILL IF THEY SEE SOMEBODY WITH A BECOME OF REGULAR CIGARETTES ANALOG IN A POCKET THEY CALL THEM OUT AND SAY THERE'S A SMOKER IN HERE, AND THEY HAVE THEM TAKE THEIR CIGARETTES OUT OF THE POCKET, DROP ON THE FLOOR AND STOMP ON IT. IT'S A CULT. IT'S A GREAT QUESTION. WISH I KNEW HOW BIG. WE DON'T KNOW HOW BIG THIS MOVEMENT IS. BUT IF WE GO BY HOW MANY SHOPS ARE OPENING UP, WHATEVER TOWN I'M IN I CAN FIND A COUPLE OF VAPE SHOPS. >> VICTORIA. >> DO WE HAVE ANY IDEA HOW MANY PEOPLE ARE USING THESE THAT HAVE NOT USED CIGARETTES, THEY BEGIN WITH THESE IN >> THAT'S THE HUGE QUESTION. THAT'S WHAT THE FEAR IS, THAT PEOPLE ARE GOING START WITH THEM AS KIDS AND GO INTO REGULAR CIGARETTES. BUT THE DATA IS REALLY SQUISHY ON THAT. PART -- THESE THINGS ARE JUST BEING ADDED SOME OF THE NATIONAL SURVEYS. THAT'S HOW NEW THEY ARE, IT TAKES SEVERAL YEARS TO GET QUESTIONS ADDED. WE'LL LEARN MORE ABOUT THAT. RIGHT NOW WE HAVE A LOT OF CONVENIENT SAMPLE STUFF WHICH ISN'T ALL THAT HELPFUL BUT GREAT QUESTION. >> I HAD A QUESTION ABOUT THE SALES DIFFERENCE BETWEEN NOCORE TEXASE GUM AND PATCHES, WHICH ARE A FORM OF DELIVERY OF NICOTINE. WHICH I THINK IS OVER THE COUNTER IN PHARMACIES. BUT I MIGHT BE WRONG ABOUT THAT. VERSUS WHAT IS A METER DOSE INHALER FOR NICOTEENE. >> THE NICOTINE INHALER IS NEVER TAKEN ON. >> THESE ARE MEDICAL DEVICES THAT ARE DESIGNED TO PROVIDE AN INHALED FORM OF NICOTINE, GUM IS A WAY TO PROVIDE THE CHEWABLE DELIVERY FORM OF NICOTINE. THE CAPSULES MUST HAVE A SET AMOUNT OR CERTAIN AMOUNT OF NICOTINE IN THEM. SO ONE HAND YOU HAVE NICORETTE GUM OVER THE COUNTER IN THE PHARMACY GIVING IT AT LEAST THE IDEA THAT IT'S MEDICATION, FOR A PURPOSE. VERSUS RECREATIONAL TYPE DRUG DELIVERY. >> YOU'RE WONDERING BY THE RELATIVE SALES OF THOSE PRODUCTS, >> WHY WOULD WE SELL THEM OVER THE COUNTER AND OTHER BE SOLD ANYWHERE YOU WANTED TO BE SOLD? I KNOW IT'S REGULATION. I'M TRYING TO MAKE THE POINT TO MY MIND THEY'RE BOTH DELIVERY DEVICES FOR NICOTINE. I COULD BE WAY OFF ON THAT. >> THERE'S DEFINITELY INFLUENCE BY TOBACCO COMPANIES AN PHARMACEUTICAL COMPANIES TO GET HOLD OF THIS WHOLE THING, WHOLE DISCUSSION. SO FAR IT'S NOT GONE VERY FAR. I THINK IT WILL BE REALLY HARD BECAUSE WHEN YOU HAVE A DEVICE THAT ISN'T A METER DOSE, IT CAN'T EVER BE A METERED DOSE, YOU CAN GET OUT WHATEVER YOU WANT TO ET GO OUT OF IT LIKE CALLING A CIGARETTE A NICOTINE DELIVERY DEVICE AN SELLING AS A METERED DOSE. THERE'S SO MUCH ELASTICITY IT'S HARD FOSI. >> THERE IS A DIFFERENCE I THINK IS THAT THERE IS A MANUFACTURING PROCESS BEHIND THE DEVELOPMENT OF THE CAP P SEWELL. IF THERE IS A CONSISTENT PROCESS IN PLACE, THEY ARE ARE FIXING THE DOSE OF INGREDIENTS WITHIN THAT CAPSULE. THAT'S DIFFERENT THAN GRINDING TOBACCO LEAVES AND WRAPPING THEN INTO A CIGARETTE. RIGHT? >> I THINK WHEN MITCH PRESENTS SOME OF THIS WILL GET SOLVEED FROM THE FDA PERSPECTIVE AND YOUR QUESTIONS WILL. BUT THE OTHER PART THE ANSWER AND PAM COULD ANSWER BETTER, NICOTINE DOSAGE ACROSS THE PRODUCTS IS QUITE VARIABLE. AND WHAT IS IN THE CAPSULE OR DELIVERY DEVICE IS VARIABLE. THE INHALATION OR AS PAM SAID, THE UPPER AIRWAY DOSE AN DEPOSITION HIGHLY DEPENDENT ON PARTICLE SIZE DISTRIBUTION, WHAT'S IN IT. WE DON'T EVEN KNOW ABOUT THAT FROM DEVICE TO DEVICE. SO IN TERMS OF HOW THESE ARE ENGINEERED IN TERMS OF DELIVERY, WE DON'T KNOW. ORIGINALLY REMEMBER NICOTINE WAS ORIGINALLY BY PRESCRIPTION, THEN IT WAS OTC SWITCH WITH THERAPEUTIC CESSATION INDICATION. FOR THESE THEY'RE JUST A PRODUCT RIGHT NOW THAT ARE SITTING IN REGULATORY LIMBO WAITING WHAT MAY FOLLOW. >> DEFINITIVE PROOF IN THE BRAIN THAT THEY HAVE EXACTLY THE SAME EFFECT, RIGHT? PROBABLY NICOTINE GUM. >> RIGHT T. OTHER THING THAT'S VERY UNHELPFUL HERE IS THE WAY THESE GROUPS HAVE ORGANIZED, WITH THE INDUSTRY BEHIND THEM, I THINK WE NEVER ENCOUNTERED SOMETHING QUITE LIKE THAT IN PUBLIC HEALTH BEFORE. IT IS KIND OF AN INTERESTING CONTRAST BECAUSE IN THE PAST WE CALL SMOKERS SMOKERS. WE DON'T CALL DIABETICS EATERS. WE HAVE A NEGATIVE LABEL FOR PEOPLE WHO SMOKE CIGARETTES. AND HERE THESE PEOPLE ARE STANDING UP BANDING TOGETHER BEING PROUD USERS OF THESE DETHE VICES, BEING PART OF A CLUB THAT'S HIGHLY RESOURCED BY THE INDUSTRY. SO IT'S GOING TO BE -- AND THEY'RE GOING TO HAVE A VOICE, A VOICE IN CONGRESS, THEY'RE GOING TO HAVE A VOICE EVERYWHERE. WHETHER WE LIKE IT OR NO. CXFC THE HORSE IS OUT OF THE BARN, WE HAVE TO GET CAUGHT UP. >> JENNIFER, LAST WORD. >> IS THERE DIFFERING APPETITE SUPPRESSION DEPENDING ON THE DEVICE? >> I WOULD LOVE TO KNOW THAT. >> I THINK THAT HAS AN IMPORTANT IMPLICATION ESPECIALLY FOR TEENAGE USERS. >> I WOULDN'T BE SURPRISED IF IT WASN'T RELATED TO HOW MUCH NICOTINE WAS AVAILABLE TO THE SMOKER. GET THAT INSULIN LEVEL SUPPRESSED AN CUT THE APPETITE. THANK YOU. >> PAM, THANK YOU. SO OUR NEXT PRESENTATION IS TOM GLYNN FROM THE ACS. HE WILL DISCUSS GLOBAL TOBACCO USE, THIS WILL BE ONE OF TWO PRESENTATIONS ON THE SUBJECT OF GLOBAL TOBACCO USE. >> THANK YOU, ALSO THANK YOU TO MICHAEL FIORI AND FROM COLLINS WHO ADDRESSED THE ACS EARLIER. I DIDN'T WANT THE GET UP AND START TALKING OR KATIE MCMAHAN BECAUSE I WAS BETWEEN YOU AND LUNCH BUT THE ACS CONTINUES TO BE ACTIVE AND WE CAN CERTAINLY TALK ABOUT IT AT SOME POINT. I WANT TO THANK BOB CROYLE AND MICHELLE BLOCK AND TEAM FOR THE OPPORTUNITY TO SPEAK P TODAY. POINT OUT AS JOHN SEMIT SAID HE HAD 20 MINUTES TO COVER 50 YEARS. I HAVE 20 MINUTES TO COVER THE WORLD. SO I ALSO MENTIONED TO MY SHE WOULD BLOCK AND STACY VANDER FELLOW NEW YORKERS, I WAS BORN AND RAISED IN NEW YORK CITY AND I KNOW HOW TO TALK REALLY FAST SO I'M GOING TO DO THAT. I WANT TO POINT OUT BY COINCIDENCE IT WAS 30 YEARS AGO THIS MONTH THAT I FIRST HAD THE OPPORTUNITY TO SPEAK TO THE NCAB, THAT TIME AS NCI STAFF MEMBER AND THE TUB WE WERE TALKING WITH THE SUPPORT OF AND DIRECTION OF JOEL COHEN WE ANNOUNCED WE FINISHED THE FIRST PHASE OF NEW TOBACCO CONTROL PROGRAM AT THE NCI AND JUST RELEASED THE 8TH RFA IN A YEAR ON TOBACCO CONTROL. DURING THOSE INTERIM 30 YEARS NCI HAS BEEN THE MOST POWERFUL FORCE DOMESTICALLY AN GLOBALLY IN SUPPORTING TOBACCO CONTROL RESEARCH, OTHERS ARE INVOLVED. BUT THE NCI JUST HAS HISTORY OF SUPPORT FOR THIS RESEARCH AND AS I SAY, I HAVE SEEN IT OVER THE PAST 30 YEARS, HAVING BEEN INVOLVED IN THING BEGINNING AND BEEN AWAY FROM IT FOR 15 YEARS U BUT ACS NOW MOVING INTO GLOBAL WITH THE SUPPORT OF HAROLD VARMUS AND ACTION TED TRIMBLE YOU'LL HEAR ABOUT IN A FEW MINUTES AND THEIR TEAMS, REREALLY ARE CONTINUING THE TRADITION OF A -- OF NCI SUPPORT FOR TOBACCO CONTROL. SO I WANT TO POINT OUT -- SEE IF I CAN MOVE THIS FORWARD. I REALIZE IN TALKING ABOUT TOBACCO CONTROL TO THIS GROUP I'M PREACHING TO THE CONVERTED -- SINGING TO THE CHOIR, AND CARRYING COALS TO NEW CASTLE. I ALSO WANT TO POINT OUT IN AN ARTICLE JUST LAST YEAR, DR. VARMUS AND (INDISCERNIBLE) CEO OF CANCER RESEARCH UK SAID WITH RESPECT TO MODIFIABLE RISK FACTORS FOR CANCER THAT REMAINS BY FAR MOST IMPORTANT AT A GLOBAL LEVEL. KEN WARNER POINTED OUT IT'S EASY TO LOSS SITE OF THE ROLE RESEARCH PLAYED IN BRING L INTERNATIONAL TOBACCO TO THE FLOOR. TOBACCO CONTROL AND TOBACCO IS EVERYWHERE. THERE IS NOT ANYWHERE IN THE WORLD WE DON'T ENCOUNTER TOBACCO EXCEPT PERHAPS ANTARCTICA AND THERE IT'S COMING I'M SURE. I HAVE ENORMOUS NUMBER OF SLIDES. THIS ONE BY THE WAY FOR THOSE WHO KNOW WHERE IS WALDO, YOU CAN SPEND A LONG TIME LOOKING FOR ALL OF THE TOBACCO ADS IN THIS PICTURE, THERE ARE AT LEAST SEVEN THAT I HAVE FOUND. SO WHEN YOU GO HOME, IF YOU WANT TO TAKE A LOOK, AND PLAY WHERE IS WALDO WITH THE KIDS. THE DISEASE CONSEQUENCE OF TOBACCO USE ARE UNIVERSAL, WE HAVE BEEN THROUGH IT A NUMBER OF TIMES BUT JUST WANT TO POINT OUT THAT IT'S NO MATTER WHERE YOU LIVE, TOBACCO USE IS GOING TO AFFECT YOU IN VIRTUALLY THE SAME WAY ONE OUT OF EVERY TWO OF YOU WHO USE TOBACCO WILL DIE FROM THAT TOBACCO USE. THAT'S UNIVERSAL. FORMS OF TOBACCO. WE TALKED A VARIETY OF FORMS OF TOBACCO. CIGARETTES, SMOKELESS L TOBACCO IN INDIA ALONE FOR HIS TEAM IDENTIFIED OVER 300 TYPES OF SMOKELESS TOBACCO IN INDIA. THOSE WHO HAVE BEEN TO INDIA KNOW YOU CAN GO ON STREET AND PICK EXACTLY WHAT YOU WANT TO PUT INTO YOUR WHATEVER YOU WANT TO PUT TOGETHER. PIPES CIGARS CLOVES CIGARETTES, HOOK, A ANDING SOMETHING CALLED ELECTRONIC CIGARETTES WHICH WE KNOW VIRTUALLY NOTHING ABOUT BUT NEED MORE RESEARCH AS PAM POINTED OUT. VERY QUICKLY GLOBAL SMOKING PREVALENCE 1.3 BILLION SMOKERS IN THE WORLD, WE EXPECT 1.7 BILLION BY 2025. ONE-THIRD OF THE GLOBAL POPULATION AGE 15 AND OVER SMOKES. THAT'S GOING TO VARY BY REGION AS I'LL POINT OUT IN A MINUTE. BUT CERTAINLY CHILDREN ARE CONCERNED THAT WE HAVE, EVERYONE SAW IT IN THE LOWER LEFT THERE, THE CNN REPORT COUPLE OF YEARS AGO OF THE THREE-YEAR-OLD INDONESIAN CHILD WHO WAS SMOKING BROUGHT TO JAKARTA TO BE TREAT AND SUPPOSEDLY ISN'T SMOKING ANY LONGER. IT'S A 20th CENTURY PHENOMENON. AT THE TURNOUT CENTURY 50 BILLION CIGARETTES WERE BEING SMOKEDDED. AND BY 2009 ABOUT .8 TRILLION BEING SMOKED. IT EXPLODED DURING THE 20th CENTURY. BUT THE EFFECTS ARE FELT IN THE 21st CENTURY. UNLESS THINGS CHANGE WITH WE'LL HAVE 1 BILLION DEATHS DURING THIS CENTURY UNLESS WE CAN TURN THINGS AROUND. WE HAVE THE OPPORTUNITY TO DO THAT. THE STAGES OF TOBACCO PANDEMIC. THIS SLIDE WAS FROM 1994. YET IT STILL HOLES PRETTY WELL. WE IN THE WESTERN COUNTRIES ARE ON THE DOWN SLOPE, NOT ELIMINATED. WE HAVEN'T REACHED THAT BUT IT IS DOWN SLOPE. SUBIS HAIR RAN AFRICA IS ON THE UP SLOPE. MAN STOPPED SMOKING BECAUSE WOMEN TOOK IT UP LATER IN MOST PLACES. WOMEN -- ONE THING THAT CHANGED A LITTLE BIT AND SHOWS THE IMPORTANCE OF TOBACCO CONTROL IS HERE WE TALK ABOUT LATIN AMERICA IN THE SECOND STAGE BUT COUNTRIES LIKE URUGUAY AND BRAZIL, WHICH INSTITUTED HARD NOSE TOBACCO CRIMINAL POLICIES, PACKS THE CIGARETTE THAT HAS VERY GRAPHIC WARNINGS ON THEM. HIGH TAXES. CESSATION AVAILABILITY. URUGUAY IN PARTICULAR IS REALLY NOW -- HAS SKIPPED A STAGE, HAS MOVED BEYOND SO AS DEMONSTRATION THAT WHEN A COUNTRYIOUSES THE RESEARCH -- COUNTRY USES THE RESEARCH THEY CAN TURN THINGS AROUND. DISTRIBUTION OF THE WORLD SMOKERS, IN 2000 ABOUT 64% WERE IN LOW AND MIDDLE INCOME COUNTRIES. BY 2025 WE EXPECT THAT TO BE 85%. THE TOBACCO INDUSTRY KNOWS WHAT THE STORY IS, THEY KNOW WHERE IT'S BEGINNING TO DECLINE, THAT I KNOW WHERE THE MARKETS ARE AND THE MARKETS ARE IN THE LOW AND MIDDLE FIRST QUARTER -- MIDDLE INCOME COUNTRIES. ALREADYIOUS AREAS, THE WESTERN PACIFIC, CHINA AND INDIA, 48%, BUT AFRICA, 3%, ABOUT 3% NOW, THAT'S WHERE THE OPPORTUNITY FOR PREVENTION OF THE EPIDEMIC IS RIGHT NOW. IS GOING INTO AFRICA AND CERTAINLY THERE IS A GREAT DEAL OF ACTIVITY, NCI IS SUPPORTING SOME OF THAT. BUT WE DO HAVE OPPORTUNITY FOR PREVENTION. NEARLY TWO-THIRDS OF THE WORLD SMOKERS LIVE IN TEN COUNTRIES AND 40% LIVE IN TWO COUNTRIES, INDIA AND CHINA. AND THE BLOOMBERG INITIATIVE, WHEN MAYOR BLOOMBERG CONTRIBUTED $750 MILLION TO TOBACCO CONTROL FOCUSED ON THESE BECAUSE THEY KNOW THAT'S WHERE THEY CAN GET THE BIGGEST BANG FOR THE BUCK. THE NEXT TWO SLIDES FASCINATING FOR A FEW REASON, ONE IS THEY SHOW WHERE WE HAVE BEEN, EASTERN EUROPE WERE THE HIGHEST LUNG CANCER RATES ARE, BECAUSE THIS IS WHERE PEOPLE BEGAN SMOKING, MEN PARTICULARLY, VERY HEAVILY AFTER WORLD WAR II. IN NORTH AMERICA IT'S BEGINNING TO DECLINE NOW BECAUSE THE SMOKING THERE STARTED IN THE 1920s OR SO AMONG MEN, 30s AND P 40s AMONG WOMEN. SO START TO SEE THAT DECLINE. LOOK AT THE RATES IN AFRICA. WE'RE DOWN, VERY, VERY LOW, THAT'S THE OPPORTUNITY TO MAKE SURE WE DON'T START TO HAVE THESE LINES GO ACROSS AND WE DO HAVE THAT OPPORTUNITY NOW. SAME THING WITH WOMEN. NORTH AMERICA, WHERE IT BEGAN LATER. IN EASTERN EUROPE IT'S CONSIDERABLY DIFFERENT THAN MEN JUST TO GO BACK, 76 VERSUS 10, BECAUSE WOMEN IN EASTERN EUROPE DID NOT PICK UP TOBACCO AS MUCH. AND BY THE TIME THEY WERE BEGINNING TO, TOBACCO CONTROL PROGRAMS BEGAN TO BE PUT IN PLACE MEANING POLICIES LIKE HIGHER TAXES, SMOKE FREE ENVIRONMENTS, SO ON. TOBACCO INDUSTRY MAKES GOODIOUS OF DATA BECAUSE THEY KNOW WHERE THEY NEED NO GO, LUNG CANCER RATES EQUALS GOOD MARKET. ABOUT A THIRD OF ALL DEATHS GLOBALLY DUE THE TOBACCO ARE CANCERS, THE REST ARE A VARIETY OF DISEASES INCLUDING PRIMARILY RESPIRATORY AND CARDIOVASCULAR DISEASE. SECONDHAND HAND SMOKE KILLS 600,000 PEOPLE A YEAR. OVER 50% OF PEOPLE IN THE WESTERN PACIFIC REGION ARE EXPOSED TO SECOND HAND SMOKE. SO SECOND HAND SMOKE IS A NON-TRIVIAL CONCERN THAT WE HAVE, PARTICULARLY WHEN IT'S MIXED IN WITH COOK STOVES WHICH HAS BEEN A PARTICULAR FOCUS OF THE STATE DEPARTMENT RECENT YEARS. ECONOMICS A COUPLE OF MINUTES. BY 2015 WHO ESTIMATES THE ANNUAL GLOBAL COST OF TOBACCO IS OVER $500 BILLION U.S. WHICH IS FIGURE HIGHER THAN GDP OF 175 OF 192 UN MEMBERS. TOBACCO IS EXPENSIVE TO A COUNTRY. IN THE U.S. ALONE FOR EVERY PACK OF CIGARETTES SOLD IT COSTS THE U.S. $10 IN HEALTHCARE COSTS AND LOST PRODUCTIVITY. SMOKING RELATED COSTS CONTRIBUTE UP TO 15% OF TOTAL HEALTHCARE COSTS IN THE HIGH INCOME COUNTRIES. AS MUCH AS 10% OF FAMILY INCOME IN SOME PARTS OF THE WORLD IS SPENT ON TOBACCO. THAT LIMITS NEEDED EXPENDITURES ON FOOD, CLOTHING, EDUCATION, SHELTER AND SO ON. NOT GOING TO COVER THIS BUT A VARIETY OF REASONS WHY TOBACCO CONTROL HAZEN RECEIVED GLOBAL ATTENTION IT NEEDS AND WE ARE BEGINNING TO ADDRESS THAT. WE NEED TO REMEMBER, THIS IS JUST A WONDERFUL QUOTE FROM A REPORT IN 2000 BY THE WHO, THE TOBACCO USE IS UNLIKE ANY OTHER THREATS THE GLOBAL HEALTH. INFECTIOUS DISEASES DO NOT EMPLOY MULTI-NATIONAL PUBLIC RELATIONS FIRMS, THERE'S NO GROUPS TO PROMOTE SPREAD OF CHOLERA AND MOSQUITOES HAVE NO LOBBYISTS. THAT JUST DESCRIBES WHAT WE'RE TOO DEALING WITH IN TERMS OF TOBACCO INDUSTRY. AS JOHN POINTED OUT THAT WAS ONE OF THE POINTS IN THE 2014 SURGEON GENERAL'S REPORT THAT THE ENEMY REMAINS THE TOBACCO INDUSTRY. TOBACCO IS A BIG BUSINESS, THE GLOBAL TOBACCO CIGARETTE MARKET IS VALUED ALMOST HALF A TRILLION DOLLARS. IT'S COMPARABLE OF THE GDP OF POLAND AND SWEDEN. 6 TRILLION CIGARETTES MANUFACTURED EACH YEAR. I WANT TO SPEND A MOMENT SUBJECTIVE TO THESE NEXT FEW SLIDES. ON TRADE ECONOMIC ISSUES, MANY COUNTRIES ARE NOW -- NOT THE U.S. YET, MITCH WILL ADDRESS THAT. HAVE GRAPHIC WARNINGS ON THEIR CIGARETTE PACKS. HERE FROM THAILAND TO CANADA, BRAZIL, AND WE'RE BEGINNING NOW TO SEE A MOVE TOWARD PLAIN PACKAGING, NO ADVERTISING ON THE CIGARETTE PACK AT ALL AND JUST A WARNING AND VERY LITTLE DEVOTED TO WHAT THE BRAND SUSPECT AS THAT HAPPENED THE TOBACCO INDUSTRY IS BEGINNING TO FOCUS ON TRYING TO USE ECONOMIC AGREEMENTS TO STOP PLAIN PACKAGING, ANY KIND OF POLICY CHANGE WHICH CAN BRING CIGARETTE USE DOWN IN A GIVEN COUNTRY. THE UNITED STATES IS NEGOTIATING NOW THE TRANSPACIFIC PARTNERSHIP AS WELL AS EUROPEAN TRADE AGREEMENT TOBACCO INDUSTRY IS ALL OVER THAT TO KEEP TOBACCO IN AS PART OF THAT, AND THE DEBATE WE'RE CONTINUING TO GO THROUGH IS CAN WE GET ENOUGH RESEARCH TO SHOW THAT BY INCLUDING -- NOT CARVING TOBACCO OUT OF THOSE TRADE AGREEMENTS WILL WE ACTUALLY SEE TOBACCO USE INCREASE IN THE COUNTRIES WHERE WE HAVE THESE TRADE AGREEMENTS THAT'S AN ONGOING DEBATE. IT HAS BEEN A BOON TO TOBACCO CONTROL. TED WILL MENTION AS WELL, THE OBJECTIVE IS TO PROTECT PRESENT AND FUTURE GENERATIONS FROM THE DEVASTATING HEALTH SOCIAL AND ECONOMIC CONSEQUENCES OF TOBACCO CONSUMPTION AN EXPOSURE TO TOBACCO SMOKE. 'S THE FIRST PUBLIC HEALTH TREATY IN THE WORLD THAT OFFER IT IS CHANCE THE ADDRESS TOBACCO CHANGE GLOBALLY, TOBACCO CONTROL GLOBALLY AND AFFECTS EVERY COUNTRY IN THE WORLD INCLUDING THE COUNTRIES THAT ARE NOT A PARTY TO TREATY WHICH INCLUDES THE UNITED STATES. ONE OF THE FEW COUNTRIES NOW THAT HAS NOT 178, 192 MEMBERS ARE PARTIES TO THE TREATY. IF THE U.S. SHOULD BY SOME CHANCE RATIFY THE TREATY, THIS IS THE SLIDE THAT I WILL BE USING. TOBACCO USE ON WINDING DOWN, PREMATURE DEATHS GLOBAL HEART DISEASE RISKS WOULD BE REDUCED BY AS MUCH AS 20 TO 25%. OVER TIME GLOBAL LIFE EXPECTANCY RISE BY AS MUCH AS THREE TO FIVE YEARS AND TRILLIONS OF DOLLARS COULD BE REDEVOTED TO PUBLIC HEALTH IN OTHER AREAS. INTERNATIONAL TOBACCO CONTROL RESEARCH CRITERIA, WE NEED TO THE ABILITY TO INFLUENCE POPULATION LEVEL PREVENTION CESSATION, ABILITY TO ADDRESS SPECIFIC COUNTRY AND REGIONAL NEEDS, EVERY COUNTRY WANTS OR REGION WANTS DATA RELEVANT TO THEM. THIS ONE IS ABSOLUTELY VITAL AND IS NOT OFTEN ADDRESSED, THE ABILITY TO ATTRACT SUPPORT FOR POLITICAL AND POLICY CHANGE. WE NEED RESEARCH FOCUSED ON THAT BECAUSE THAT'S WHERE WE SEE THE DIFFERENCE. PETER GREENWHAT WOULD AND I WERE TALKING AT THE BREAK WHAT NCI DID IN 1980s SUPPORTING TWO MONUMENTAL STUDIES ON -- CALLED THE ASSIST PROGRAM AND THE COMMIT PROGRAM WHICH LOOKED AT DOMESTICALLY HOW POLICY CHANGE EFFECT TOBACCO USE. AND THEY ARE NOW BEING USED INTERNATIONALLY. WE NEED MORE RESEARCH ON CAPACITY BUILDING, FUNDING, WE NEED MORE FUNDING, THAT'S A STANDARD BUT GATES AND BLOOMBERG INITIATIVE HAVE BEEN ENORMOUSLY USEFUL BUT NOT FOCUSED ON RESEARCH. WE NEED TO ESTABLISH POLITICAL WILL. AWARENESS AND PUBLIC RELATIONS REGARDING THE ENORMITY OF TOBACCO EFFECTS. MANY COUNTRIES STILL DON'T UNDERSTAND THAT. AND SPECIFIC TOBACCO CONTROL TOPICS FOR RESEARCH I WON'T GO THROUGH ALL THESE, BUT THEY'RE IN THE BOOK. BUT WE NEED A WIDE VARIETY OF RESEARCH. TALKING ABOUT TRADE AGREEMENTS, THAT'S ONE WE DON'T OFTEN SEE RESEARCH ON AND WE NEED RESEARCH IN THESE AREAS. SEEMS OVERWHELMING THIS LIST BUT WE STILL AS WE POINT OUT AT THE BEGINNING WE HAVE 1.3 BILLION SMOKERS WHO NEED RESEARCH ON IN THESE ISSUES. COMPLIMENTARY WE NEED NEW GENERATION OF TOBACCO RESEARCH CONTROL LEADERS, RAISE THE PROFILE ON TOBACCO RESEARCH ON GLOBAL HEALTH AND DEVELOPMENT AGENDAS. WE NEED TOBACCO AS A DEVELOPMENT ISSUE. WE NETWORK THE NCD GROUPS, HARNESS INTEGRATE MODERN COMMUNICATIONS TECHNOLOGIES, ERIC AUGUSTINE AND HIS GROUP AT NCI ARE GLOBAL LEADERS IN DOING THIS. I WON'T GO OUTTHREW THESE BECAUSE MICHELLE WILL PULL ME OFF THE STAGE IN A MOMENT. I WANT TO MENTION AT A MEETING RECENTLY WITH INTERNATIONAL CANCER CONTROL OR CANCER CENTERS, THAT DR. VARMUS AND DR. KUMAR PUT TOGETHER WE TALKED THE PROPOSAL FOR A GLOBAL CONSORTIUM TOBACCO CONTROL RESEARCH. THIS WILL BE AMONG CANCER CENTERS GLOBALLY. THIS KIND OF CONSORTIUM COULD DO A NUMBER OF THINGS OVERARCHING STAR FOR INTERNATIONAL RESEARCH COLLABORATION, AID IN DEVELOPMENT RESEARCH COMMUNICATION NETWORKS. FACILITATE EXCHANGE AND DISSEMINATION OF INFORMATION, PROMOTE MEASURES WHICH IS DESPERATELY NEEDED. INCREASE RESEARCH CAPACITY, SERVE MEANINGFUL FUNCTION AND TOBACCO CONTROL RESEARCH. THIS WILL NOT BE DECIDED TODAY BUT NEEDS TO BE SERIOUSLY CONSIDERED. I THINK TED MAYBE TOUCHING ON IT AS WELL. SO I WANT TO CLOSE WITH INTERNATIONAL THEME. THIS IS A PHOTO IN 1972 OF THE FIRST FOUR FRENCH HEART TRANSPLANT PATIENTS. AFTER THEIR HEART TRANSPLANTS. CIGARETTE, CIGARETTE. CIGARETTE. IN MOST PLACES TODAY YOU CANNOT GET A HEART TRANSPLANT IF YOU'RE A CONTINUING SMOKER. SO WE HAVE MADE PROGRESS IN THESE 40 YEARS. THANK YOU. >> THANKS, TOM. DO WE HAVE QUESTIONS? >> TOM, HAS THERE BEEN DISCUSSION AT THE EXECUTIVE LEVEL ABOUT WHEN FRAMEWORK CONVENTION CAME OUT 2003, 2004, PRESIDENT BUSH DECIDES NOT TO FORWARD IT TO THE SENATE FOR RATIFICATION. IS THERE ANY CONSIDERATION FOR TRYING TO IN THE CURRENT ADMINISTRATION TO GET IT RATIFIED? >> I DON'T WANT TO SPEAK -- CAN'T SPEAK FOR THE CURRENT ADMINISTRATION BUT JUST DOING HEAD COUNTS, WE NEED 67 VOTES IN THE SENATE. THEY'RE NOT THERE. THEN A MATTER WHETHER THE PRESIDENT WANTED TO SEND TREATY TO THE SENATE AND ESSENTIALLY. WE KEEP UP -- WE DID HEAD COUNTS VARIOUS TIMES AN KATIE MCMAHAN IN THE CANCER ACTION NETWORK GROUP AT ACS CAN SPEAK TO IT. WE DID HEAD COUNTS AT VARIOUS TIMES AND THE BEST OF TIMES THE BEST WE GET IS HIGH 50s, MAYBE 60. U.S. JUST HAS A HISTORY OF NOT RATIFYING IN GENERAL. SO WE HAVEN'T DONE LAND MINE TREATY AND RIGHTS OF A CHILD. SO IT'S NOT TOBACCO SPECIFICALLY, I THINK THAT'S BEING PICKED ON HERE. BUT I HOPE TO USE THAT FIXED LINE SLIDE AT SOME POINT. OKAY. TOM, THANKS VERY MUCH. >> THANK YOU. >> WE'LL MOVE TO TED TRIMBLE, REFERENCED ON SEVERAL OCCASIONS AND WILL CONTINUE DISCUSSION ABOUT THE GLOBAL PROBLEM AND A PLAN NOW FROM PERSPECTIVE OF THE NCI. >> THANKS. I'M GOING TO CLEAN UP HERE IN TERMS OF TRYING TO GO OVER SOME OF THE TOPICS THAT HAVE BEEN DISCUSSED ALREADY AND PUT IN PERSPECTIVE, NCI APPROACH. ABOUT TWO YEARS AGO, THE CENTER WAS GETTING STARTED WE CONVENED A STAKEHOLDERS MEETING. MANY WERE HERE, AND JOHN (INDISCERNIBLE) HAVE PULLED TOGETHER A LOT OF INFORMATION ABOUT TOBACCO CONTROL RESEARCH AND THIS REIDENTIFIED AS HIGH PRIORITY ITEMS FOR CENTER, YOU SEE THE OTHER THEMES HERE. I WANT TO TOUCH BRIEFLY ABOUT THE FRAMEWORK CONVENTION. HIGHLIGHT THE FACT THAT MUCH OF THE RESEARCH THAT INFORMED THAT CONVICTION WAS SPONSORED BY NCI. WE HER THE VERGE OVER THE DECADE. BUT I THINK IT'S IMPORTANT FOR US TO BE AWARE THAT THE GOOD WORK AND GUIDANCE OF THE CONVENTION WAS LARGELY BASED OR IN LARGE PART BASED ON RESEARCH THAT NCI HAS SPONSORED. YOU HAVE SEEN THE SLIDE BEFORE FROM MICHELLE, WE'RE CONNING TO WORK CLOSE WHETHER I THE WORLD HEALTH ORGANIZATION AND PULLED TOGETHER A NUMBER OF REPORTS. WE WORKED WITH CDC HELPING WHO DEVELOP THE ACTION PLAN WHICH WAS JUST ENDORSED BY THE WORLD HEALTH ASSEMBLY LAST SPRING. AND P THE GOAL HERE, HAVE 25% REDUCTION PREMATURE MORTALITY FROM NCD AND YOU CAN SEE THE VARIOUS FACTORS THAT THEY ARE ARE VOLUNTARY TARGET FOR ONE IS A 30% REDUCTION IN TOBACCO USE. I WANT TO START EMPHASIZING THE IMPORTANCE OF GLOBAL HEALTH DIPLOMACY. THIS IS AN ARTICLE FROM JAKART A GLOBE WHEN DR. VARMUS VISITED INDONESIA WITH BRUCE ALBERTS TWO SUMMERS AGO. INDONESIA IS ONE OTHER COUNTRY THAT'S NOT SIGNED THE FRAMEWORK CONVENTION BUT THERE ARE A NUMBER OF ARTICLES THAT CAME OUT IN THE PRESS AS WELL AS ON RADIO AND TV. IN INDONESIA WHICH WERE VERY EFFECTIVE ACCORDING TO OUR CDC AND U.S. AID FRIENDS IN JAKARTA. WE'RE ALSO TRYING TO BUILD ON THIS WORK. MARK PARIS OMNDOLA IS IN BEIJING AS INDUSTRY SCIENCE FOLLOW FOR THREE MONTHS AND THE DATA AT THE TIME PRESENTED CHINA IS THE LARGEST NUMBER OF TOBACCO USERS IN THE WORLD. SO HE WILL BE HHS LEAD FOR PARTNERSHIP ON CHINA IN SMOKE FREE WORKPLACES ABOUT PROVIDE TECHNICAL ASSISTANCE ON TOBACCO CONTROL IN HEALTHY CITIES. HE'S ALSO GOING TO BE SPENDING THREE MONTHS OR THREE WEEKS IN JAKARTA THANKS TO DR. VARMUS'SRY THERE AND U.S. AID IS VERY EXCITED ABOUT WHAT CAN BE DONE WITH TOBACCO CONTROL IN INDONESIA. SO MARK WILL GET THINGS START AND THEN (INDISCERNIBLE) DONE AN FROM OUR CENTER WILL BE THERE FOR ANOTHER THREE MONTHS TO HELP U.S. AID AND CDC AND INDONESIAN COLLEAGUES WORK ON TOBACCO CONTROL. YOU CAN SEE THE LIST OF PROJECTS THAT THEY PLAN TO CARRY OUT IN INDONESIA. I ALSO WE HAVE HEARD A LITTLE BIT ABOUT THE GREAT WORK (INAUDIBLE) HAS BEEN THE LEAD FOR AS PART OF FOR HHS AND BEHAVIORAL M HEALTH INTERVENTIONAL PROJECTS, WE'RE VERY EXCITED ABOUT THE OPPORTUNITY TO EXPORT TO OTHER COUNTRIES, YOU SEE WHAT WE'RE DOING IN CHINA, SOUTH AFRICA, BRAZIL, AND WE ALSO EXPLORING OPPORTUNITIES IN INDIA, THE CARIBBEAN, SOME OF THE SOUTH PACIFIC ISLAND, MEXICO AND GUATEMALA. SO WE SEE A GREAT OPPORTUNITY AND AGAIN ERIC AND COLLEAGUES ARE THE LEADS FOR HHS. IN THESE ACTIVITIES. MICHELLE MENTIONED THIS, MITCH IS IN THE AUDIENCE, MARK WOULD BE HERE IF HE WASN'T IN BEIJING. BUT THIS IS AN IMPORTANT REPORT THAT WILL COME OUT SHORTLY ON SMOKELESS TOBACCO. THE BIG PRESS ROLL OUT IS INDIA, WHEN TOM FREEDEN IS THERE, WE'RE EXCITE ABOUT THIS REPORT AND HOPE P WE WILL BE INFLUENTIAL PARTICULARLY INDIA AND SOUTHEAST AWHERE ORAL TOBACCO USE IS SUCH A PROBLEM. WE HAVE RECENTLY REACHED OUT AND DEVELOPED A PARTNERSHIP WITH U.S. AID TO HELP FUND RESEARCH IN TOBACCO CONTROL. THIS IS STARTING IN PARTNERSHIP WITH U.S. AID OFFICES IN INDONESIA AND THE PHILIPPINES. AND WE CAN -- THIS STARTED WITH THE TRIP THAT DR. VARMUS MADE TO INDONESIA TWO SUMMERS AGO. THE U.S. AID AND CDC FOLKS UNDERSTOOD THE IMPORTANCE OF TOBACCO CONTROL, CAPLETS AND SAID WE WANT TO INCLUDE TOBACCO CONTROL RESEARCH AS PART OUR HEALTH PROGRAM, PREVIOUSLY ON INFECTIOUS DISEASE MATERNAL CHILD HEALTH SO WE'RE EXCITED ABOUT THE FACT THAT IN THE CURRENT CYCLE WE ARE WE QUESTING APPLICATIONS PARTNER VISITORS IN THE U.S. AND INVESTIGATORS IN COUNTRY FOCUSED ON TOBACCO CONTROL. MICHELLE AND TOM MENTIONED THIS BUT THIS SUMMARIZES SOME OF OUR UNANSWERED QUESTIONS HOW DIFFERENCE THES IN PRODUCTS, PATTERNS OF USE, POPULATION CHARACTERISTICS, CONTRIBUTE TO VARIATIONS. HOW DO SOCIO ECONOMIC TRANSITIONS CONTRIBUTE TO THIS, WHAT TYPES OF CESSATION INTERVENTIONS ARE THE MOST EFFECTIVE AND HOW PRICE AND POVERTY AND OTHER HEALTH OUTCOMES AFFECT TOBACCO USE. IN ADDITION A NUMBER MENTIONED THE IMPORTANCE OF LOOKING IN THE U.S. ON A STATE BY STATE LEVEL BUT CLEAR AROUND THE GLOBE WE HAVE WHAT SOME CALL GLOBAL TOBACCO CONTROL LABORATORY, MANY DIFFERENT COUNTRIES ARE ADOPTING AND MODIFYING THE RECOMMENDATIONS FOR THE FRAMEWORK CONVENTION. OBVIOUSLY THEY HAVE DIFFERENT CONDITIONS IN EACH COUNTRY SO WE DO HAVE ENORMOUS NATURAL EXPERIMENT SO WE CAN WORK WITH COLLEAGUES AROUND THE WORLD TO STUDY WHAT SEEMS TO WORK BEST IN DIFFERENT COUNTRIES AND DIFFERENT REGIONS AND DIFFERENT SOCIO ECONOMIC CONDITIONS. I WANT TO BRIEFLY GO OVER OUR PAST AND CURRENT GLOBAL TOBACCO CONTROL GRANTS. MICHELLE, SOME OF THIS DATA AS PART OF OUR OVERALL SURVEY. SINCE IN 2002 WE HAD SOMEWHERE IN THE RANGE OF 50 TO 60 GRANTS FOR TOBACCO CONTROL. GLOBALLY. YOU CAN SEE HOW THEY DIVIDE IN TERMS OF CAPACITY BUILDING, EPIDEMIOLOGY INTERVENTION POLICY AND LABORATORY. AT CURRENTLY WE HAVE 21 ACTIVE GRANTS IN LOW AND MIDDLE INCOME COUNTRIES. WE HAVE A PO-1, THAT EFFECTIVENESS OF TOBACCO CONTROL POLICIES AN P HIGH AND LOW INCOME COUNTRIES AND YOU HEARD TOM MENTIONED AN IMPORTANT AREA. WE WORK WITH FOGARTY ON THE FRAMEWORK PROGRAMS FOR GLOBAL HEALTH, NOT SPECIFIC TO TOBACCO CONTROL BUT IS ONE OF THE PROGRAMS WE USE TO SUPPORT TOBACCO RESEARCH. PROBABLY THE MOST IMPORTANT IS INTERNATIONAL TOBACCO AND HEALTH RESEARCH CAPACITY BUILDING. THIS IS LED BY FOGARTY AND PARTNERSHIP WITH PARTICULARLY WITH NATIONAL INSTITUTE ON DRUG ABUSE AND NCI. WE HAVE EIGHT PROJECTS AND 13 COUNTRIES AND YOU SEE THE PINS HERE WHERE THE COUNTRIES ARE, NUMBER IN LATIN AMERICA, A NUMBER IN EAST COAST AFRICA EASTERN EUROPE AND CHINA. THESE ARE THE U.S. -- THEY'RE PAIRED WITH LOCAL INVESTIGATORS IN COUNTRY AS WELL AS U.S. INSTITUTIONS AND YOU CAN SEE THE U.S. INSTITUTIONS LISTED HERE YOU CAN SEE THE SITES AND THEMES OF THE RESEARCH HERE. I ALSO WANT TO MENTION THE FACT WE ARE WORKING CLOSELY TO SPONSOR CONFERENCES. ONE EXAMPLE IS, WE JUST HAD IN INDIA IN THE FALL THE END GAUGE FOR TOBACCO, IT WAS BOTH FOR REGIONAL MEETING. WE PROVIDE FUNDING SUPPORT AND TECHNICAL ASSISTANCE E WE HAD SCHOLARSHIPS FOR PARTICIPANTS FOR LOW AND MIDDLE INCOME COUNTRIES. WE HAD PRE-CONFERENCE WORKSHOP AS WELL AS A SPECIAL SYMPOSIUM TO PRESENT RESULTS FROM THE SMOKELESS TOBACCO WHICH I MENTIONED EARLIER. ANOTHER SERIES OF CONFERENCES THAT WE HELPED ORGANIZE ARE WORLD CONFERENCES ON TOBACCO FOR HEALTH EVERY THREE YEARS, 14th CONFERENCE IN INDIA, 2012, IT WAS IN SINGAPORE, THE NEXT CONFERENCE WILL BE IN ABUABAI. SO THESE ARE IMPORTANT TO LOOK AT CURRENT STATE OF RESEARCH TO LOOK AT THE IMPLEMENTATION OF THE FRAMEWORK CONVENTION. SO THAT ENDS ANY PRESENTATION, HAPPEN MY TO ANSWER ANY QUESTIONS. -- THAT ENDS MY PRESENTATION, HAPPY TO ANSWER ANY QUESTIONS. >> TED THANK YOU. QUESTIONS. >> MICROPHONE PLEASE. >> FOLLOWING UP ON WHAT TOM SAID ABOUT ACS STRATEGY AND YOUR STRATEGY WITHIN THE NCI, WHAT OPPORTUNITIES DO YOU SEE IN TERMS OF COLLABORATION FUNDING ESPECIALLY THE RELATIONSHIP THAT WE HAVE HEARD THAT BEING GATES WAS INTRINSIC IN THIS PARTICULAR PROBLEM AND THIS IS A BIG FUNDER OF GLOBAL HEALTH PROGRAM, I WANT TO SEE IF YOU HAVE IN ROADS INTO THAT. >> WE PUT THIS ON OUR WERE LIST, DR. COLLINS ASKED ALL THE INSTITUTES TO PUT TOGETHER A SHORT LIST OF TOPICS THEY WOULD LIKE US TO EXPLORE COLLABORATION WITH THE BILL AND MELINDA GATES FOUNDATION, TOBACCO RESEARCH PARTICULARLY SECOND HAND SMOKE AFFECTING CHILDHOOD DISEASES WAS OUR APPROACH BECAUSE WE KNOW DEATH UNDER AGE 5 ARE BILL AN MELINDA, THERE'S ALSO THE GLOBAL ALLIANCE FOR CHRONIC DISEASE WHICH BRINGS TOGETHER RESEARCH FUNDERS FROM NUMBER OF THE BIG COUNTRIES TO WORK TOGETHER ON CHRONIC DISEASE SO WE PUT TOBACCO CONTROL RESEARCH ON OUR LIST TO PROPOSE TO THEM, THEY HAD THREE, CURRENTLY PLANNING THIRD CALL FOR JOINT OR PARALLEL RESEARCH PROGRAMS THE FIRST WAS HYPERTENSION, SECOND ON DIABETES, WE HOPE TO GET TOBACCO CONTROL RESEARCH ON THE THIRD CALL. >> THE ACS IS WAY TOO MALL TO DO MUCH ON ITS OWN IN TERMS OF INTERNATIONAL. CERTAINLY BIG INTERNATIONAL COMMITMENT IN TERMS OF WANTING TO DO MORE BUT OUR FUNDING IS LOW AND AS TED SAID WE HAVE FOUND WAYS COLLABORATING. WE HAVE A GRANT RIGHT NOW FROM THE GATES FOUNDATION SPECIFICALLY TO HELP ORGANIZE A CONSORTIUM IN AFRICA TO WORK ON POLICY CHANGE TOBACCO CONTROL, FOCUSING ON TEN COUNTRIES, DON'T ASK ME WHAT THE COUNTRIES ARE. WE ARE WORKING ON ISSUES LIKE SMOKE FREE ENVIRONMENTS, INCREASING ACCESS TO CESSATION. TYPES AND SO ON, THAT'S THROUGH GATES. WITH BLOOMBERG WE HAVE A NUMBER OF INITIATIVES THROUGH ROSS AND HER GROUP IN ATLANTA. SO WE ARE CONSISTN'TLY LOOKING FOR WAYS TO COLLABORATE AND ESSENTIALLY USE ACS FUNDS TO TRY AND FIND OTHER FUNDS FOR THAT. AND SOME OF THE WORK WE DO WITH NCI AS PART OF THAT. ANY FURTHER QUESTIONS? IF NOT, TED, THANK YOU AGAIN. WE WILL NOW MOVE TO OUR FINAL PRESENTATION IN THIS COLLECTION OF TALKS ON TOBACCO CONTROL FROM MICHELLE ZELLER FROM THE FDA. TALKING ABOUT REGULATORY ISSUES AND PARTNERSHIPS WITH THE NCI. >> THANK YOU. REALLY A PLEASURE TO BE HERE AND BE ABLE TO TALK TO NCAB. LET ME MAKE ONE REMARK ON THE GLOBAL SITUATION BECAUSE THAT WAS NOT PART OF MY TALK. I'LL HAVE A FEW THINGS TO SAY IN CONTEXT OF THIS SLIDES ON THE REGULATORY STATUS OF E-CIGARETTES. I DON'T WANT THE BOARD TO THINK THAT JUST BECAUSE THE UNITED STATES GOVERNMENT HAS NOT RATIFIED THE FRAMEWORK CONVENTION THAT WE ARE NOT PLAYERS THE UNITED STATES GOVERNMENT AND TOBACCO CONTROL COMMUNITY IN THE UNITED STATES IS VERY HEAVILY INVOLVED. IN THE WORK OF THE FRAMEWORK CONVENTION. AND THE UNITED STATES GOVERNMENT PLAY AS CRITICAL ROLE, THIS IS FDA, CDC. RELEVANT INSTITUTES AT NIH. UNFORMING TWO VERY IMPORTANT COMMITTEES THAT WHO HAS CREATED OVER THE YEARS THROUGH TOBACCO FREE INITIATIVE, ONE IS ON TOBACCO PRODUCT REGULATION, WE PLAY A LEADING ROLE INFORMING THE THINKING OF REGULATORS AROUND THE WORLD. AS THEY ARE TRYING TO FIGURE OUT WHAT TO TO WITH THE VARIOUS ARTICLES IN THE FRAMEWORK CONVENTION THAT RELATE TO PRODUCT REGULATION. THE OTHER ONE IS LED BY CDC. THERE IS A GLOBAL NETWORK OF TOBACCO TESTING LABORATORIES. I WOULD SAY WITHOUT THE LEADERSHIP OF THE UNITED STATES GOVERNMENT THAT NETWORK WOULDN'T EXIST AND THE GOVERNMENTS THAT NOW HAVE INFRASTRUCTURE AND CAPACITY TO DO LABORATORY TESTING WOULDN'T HAVE BEEN ABLE TO DO IT WITHOUT OUR ROLE. I'M NOT -- I'M NOT BRAGGING HERE, I JUST WANT Y'ALL TO UNDERSTAND THAT WE HOPE TO SEE TOM'S SLIDE AND THAT PIGS WILL FLY. ON THE OTHER HAND WE'RE NOT HOLDING OUR BREATH BUT THAT DOESN'T MEAN WE HAVEN'T BEEN AND WILL REMAIN VERY ACTIVELY INVOLVED IN THE WORK OF THE FRAMEWORK CONVENTION AND FDA CLOSE TO REACHING AGREEMENT WITH WHO WHERE WITH MODEST FUNDING WHO WILL PLAY A POWERFUL ROLE CONVENING ALL REGULATORS WHETHER RATIFYING THE FRAMEWORK CONVENTION OR NOT. I WANTED TO MAKE THAT POINT. >> I WAS ASKED TO TALK ABOUT THE ROLE OF REGULATORY SCIENCE AT FDA, OUR PROGRAMMATIC PRIORITIES AND WONDERFUL COLLABORATION THAT WE HAVE WITH NIH. THAT'S WHAT I'M GOING TO TALK ABOUT. AS YOU HEARD, CONGRESS PUT FDA BECOME IN THE BUSINESS OF REGULATING TOBACCO PRODUCTS IN 2001, 20 YEARS AGO THIS WEEK TWO DAYS AGO WHEN FDA ANNOUNCED THE LAUNCH OF THE FIRST INVESTIGATION OF THE ROLE OF NICOTINE IN THE DESIGN AND MANUFACTURE OR CIGARETTES AND SMOKELESS TOBACCO PRODUCTS WHICH I HAD THE PRIVILEGE OF WORKING ON WITH DAVID KESSLER, CAN'T BELIEVE THIS WEEK IS 20 YEARS SINCE THE BAND OF US WERE CRAZY ENOUGH TO LAUNCH THAT INVESTIGATION AND TRY TO REGULATE THE TOBACCO INDUSTRY THROUGH JURISDICTION WHICH AS YOU HEARD EARLIER WAS OVERTURNED BY THE SUPREME COURT. NINE YEARS LATER THE SUPREME COURT IN 2000 CONGRESS PUT US BACK IN THE BUSINESS OF REGULATING TOBACCO PRODUCTS, UNDER A DIFFERENT STANDARD. WHETHER E EAR CALLING THE APPROACH TO REGULATION, AND THE ROLE OF REGULAR WILLLATORY SCIENCE -- REGULATORY SCIENCE A BROAD PUBLIC HEALTH FRAMEWORK. HERE IS THE STANDARD. WE'RE REGULATING TOBACCO PRODUCTS IN A MANNER APPROPRIATE FOR PROTECTION OF PUBLIC HEALTH. YOU DON'T SEE PHRASE SAFETY AND EFFICACY. THAT'S HOW WE TRIED THE FIRST TIME AND THE SUPREME COURT DIDN'T BUY IT. IT'S A PUBLIC HEALTH STANDARD. NOR SAY ABOUT WHAT THE MANDATORY POPULATION LEVEL BEHAVIORAL CONSIDERATIONS ARE AND REGULAR ROGUE OF REGULATORY SCIENCE INFORMING IMPLEMENTING THOSE PROVISIONS. THERE IS A PUBLIC HEALTH OBJECTIVE HERE TO USE TOOLS OF REGULATION TO REDUCE THE DEATH AND DISEASE TOLL FROM TOBACCO. THE 50th ANNIVERSARY RESEARCH UPPED THE NUMBER OF ANNUAL DEATHS TO 480,000, OVER 480,000. THAT'S A BIG NUMBER TO WRAP ONE'S HAND AROUND. HERE IS ANOTHER ONE. BETWEEN NOW AND MID CENTURY, THERE WILL BE JUST UNDER 18 MILLION PREVENTABLE DEATHS IN THE UNITED STATES FROM TOBACCO USE. 18 MILLION BETWEEN NOW AND MID CENTURY USING REVISED NUMBERS FROM THE SURGEON GENERAL'S REPORT. THE ROLE AND REGULATION IS READY UNPRECEDENTED. IN FIGURING HOW TO REGULATE THE PRODUCTS AND THE MARKETPLACE. TO TRY TO REDUCE THAT DEATH TOLL. AND UNDER THIS POPULATION LEVEL PUBLIC HEALTH STANDARD, THE JOB OF FDA IS TO ASSESS THE RISKS AND THE BENEFITS TO THE POPULATION AS A WHOLE FIGURING IMPACTS ON USERS AND P NON-USERS, MORE TO SAY THROUGHOUT THE TAUGHT. HOW WE DOING IT? AT 35,000 FEET IT'S A LENGTH THINK PIECE OF LEGISLATION AND THE REGULATORY PROVISIONS ARE COMPLICATED BUT TRY TO KEEP HIGHER LEVEL, THIS IS WHAT WE ARE DOING. IN AN UNPRECEDENTED WAY USE TOOLS OF REGULATION. THE FIRST IS TO UNDERSTAND THE PRODUCTS WHICH IS A POLITE WAY OF SAYING THE COMPANIES MUST PROVIDE US WITH CERTAIN INFORMATION ABOUT THE PRODUCTS THEY WANT TO MARKET AND THEN WE HAVE THE POWER TO COMPEL THEM TO GIVE ADDITIONAL INFORMATION SO WE CAN BEST UNDERSTAND WHAT IS MAKING THESE PRODUCTS TICK. WE ALSO HAVE THE AUTHORITY AND WE ARE RESTRICTING PRODUCT CHANGES. MORE TO SAY ABOUT THAT IN A MINUTE. WE HAVE AUTHORITY TO PROHIBIT MODIFIED RISK TOBACCO PRODUCTS. STATE EITHER REDUCED EXPOSURE OR RISK. THE COMPANIES THAT MAKE THE YOU CANS THAT WE REGULATE CANNOT DO THAT WITHOUT AN ORDER FROM FDA. WE HAVE BROAD POWERS TO RESTRICT MARKETING AN DISTRIBUTION, SUBJECT TO THE CONSTITUTION AND FIRST AMENDMENT. WE HAVE POWERFUL TOOLS, MORE TO SAY ABOUT THIS IN A FEW MINUTES. TO OVER TIME DECREASE THE HARMS ASSOCIATED WITH THE USE OF TOBACCO PRODUCTS. AT THE END OF THE DAY FDA IS A LAW ENFORCEMENT AGENCY. SO WE HAVE POWER TO ENSURE COMPLIANCE. WE CAN DO THAT THROUGH EDUCATION, SO THAT ALL SECTORS REGULATE UNDERSTAND WHAT THE RULES OF THE ROAD ARE BUT BACKED UP WITH INSPECTIONS AND ENFORCE.. WE HAVE A VERY IMPORTANT RESPONSIBILITY TO EDUCATE THE PUBLIC. I'LL GIVE AN EXAMPLE IN A MINUTE. ALL ROADS LEAD TO SCIENCE BASED REGULATORY ACTION AND EVALUATION. REGULATORY SCIENCE, NOT JUST SCIENCE. IT'S REGULATORY SCIENCEFUL THINK OF IT AS OXYGEN WITH OUR PROGRAM. WE CAN'T COME UP WITH THE POLICIES. WITHOUT AN ADEQUATE SCIENCE BASE BECAUSE WE KNOW WE WILL BE SUED WHEN IT COMES TO USING TOOLS OF REGULATION. IT IS THE RIGHT OF ANY INTERESTED PARTY TO SUE REGULATORY AGENCY MAKING POLICY FOR RULE MAKING. WE HAVE TO HAVE THE STRONGEST EVIDENCE BASE USING REGULATORY SCIENCE TO INFORM HOW TO INTERPRET AND APPLY NEW AUTHORITIES. THE LAW -- WE'RE COMING ON THE FIFTH ANNIVERSARY OF THE LAW BUT WE ARE STILL EARLY DAYS OF INTERPRETING AND APPLYING SOME OF THE MOST POWERFUL TOOLS IN THIS STATUTE. WE'RE NOT DOING THIS UNDER TRADITIONAL STANDARD AND EFFICACY. THAT'S HUGE IMPLICATIONS FOR REGULATORY SCIENCE BECAUSE IT'S NOT ONLY THE MORE CONVENTIONAL CLINICAL TRIAL THAT IS GOING TO INFORM FDA THINKING HERE. OUR JOB TO ASSESS NET POPULATION HEALTH IMPACTS OF ANY PRODUCTS, ANY CLAIMS THAT WE REGULATE, CONVENTIONAL PRODUCTS, UNCONVENTIONAL PRODUCTS LIKE E-CIGARETTES. BUT THE LAW IS ALSO CLEAR ABOUT HOW WE CANNOT SPEND THAT WHEN IT COMES TO RESEARCH, RESEARCH DOLLARS CANNOT GO TO DIAGNOSIS OR TREATMENT OF DISEASE NOR TOWARDS CLINICAL PRACTICE. I BECAME CENTER DIRECTOR A YEAR AGO. MY SECOND STINT AT FDA. WHAT I -- WHAT I WALKED INTO WAS THIS WONDERFUL COLLABORATION BETWEEN NIH AND FDA THAT STARTED IN 2010, LESS THAN ONE YEAR AFTER PASSAGE OF OUR LAW WITH LEADERSHIP COUNSEL FOR REGULATORY SCIENCE, THAT SPAWNED TOBACCO REGULATORY SCIENCE PROGRAM TRYST WHICH IS UP AND RUNNING. AND THAT TO ME AS POLICY GUY IS THE BEST OF WHAT BOTH ORGANIZATIONS CAN BRING TO THE GAME WHEN IT HELPS FIGURE HOW TO USE THE TOOLS IN THIS LAW. TO INDEPENDENTLY REDUCE, WE'RE THE ONES WITH EXPERTISE IN THE TOBACCO REGULATORY SCIENCE, WE HAVE STATUTORY AUTHORITY. VERY IMPORTANTLY WE HAVE THE MONEY. NIH HAS EXPERTISE IN THE RESEARCH AND THE WONDERFUL INFRASTRUCTURE THAT YOU HAVE CREATED OVER TIME AND WE'RE NOT INTERESTED IN DUPLICATING OR REPLICATING THAT, WORK WITH YOU THROUGH YOUR MECHANISMS. IT'S JUST A WONDERFUL MARRIAGE OF TWO INSTITUTIONS TO ENABLE US TO WORK WITH THE RELEVANT INSTITUTES TO GET THE RESEARCH DONE TO CREATE THE REGULATORY SIGN BASE FOR PRODUCT REGULATION. WITH THAT, THERE ARE GOING TO BE MANY NEW FUNDING OPPORTUNITIES. ON THIS SLIDE IF YOU LOOK AT THE BOLDED ENTRIES THAT'S JUST AN EXAMPLE OF WHAT'S HAPPENEDDED SINCE TRYST WAS CREATED. I HAVE MORE TO SAY ABOUT SOME OF THE COLLABORATIONS BUT THIS IS VERY, VERY ACTIVE, IT'S GETTING ATTENTION AT THE HIGHEST LEVELS. INSIDE OF NIH, NCI, FDA AND DEPARTMENT THE FUTURE OF PRODUCT REGULATION IS REALLY RIGHT HERE. COUPLE OF EXAMPLES OF THIS COLLABORATION WITH NIH AND INSTITUTES. WHAT WE CALL THE POPULATION ASSESSMENT OF TOBACCO AND HEALTH STUDY. ALL THE QUESTIONS THAT PAM POSED ABOUT E-CIGARETTES. SOME WERE IN SEATTLE AT THE ANNUAL MEETING FOR SOCIETY FOR RESEARCH ON TOBACCO RESEARCH. THIS YEAR'S MEETING SHOULD HAVE BEEN NUMBERED SOCIETY FOR RESEARCH OF NICOTINE AND E-CIGARETTES. EVERY SESSION SEEMED WAS ON E-CIGARETTES AND JUST AS PAM DESCRIBED, WE WALKED INTO THOSE ROOMS WITH QUESTIONS, WE WALKED OUT OF THOSE ROOMS WITH QUESTIONS, AND WE DID NOT WALK OUT OF THOSE ROOMS WITH MANY ANSWERS. THE PAST STUDY IS A 60,000 PERSON LONGITUDINAL STUDY WENT INTO THE FEEL LAST SEPTEMBER, 7,000 KIDS, 53,000 ADULTS, NOT SAYING WE'RE GOING TO GET ALL THE ANSWERS ON E-CIGARETTES BUT SOONER RATHER THAN LATER WE'RE GOING TO START TO GET THE ANSWERS ON WHO IS USING THESE PRODUCTS, HOW ARE THEY BEING USED AND WE ARE GOING TO TAKE BIOSPECIMENS FROM ADULTS AN THOSE WILL BE -- AND WE'LL L BE ABLE TO TO COMPARE OVER TIME THE ANSWERS THEY GIVE TO THE QUESTIONS ABOUT BEHAVIORAL PATTERNS WITH WHAT THE BLOOD URINE AND SALIVA IS TELLING US. BEYOND THAT THE ANSWERS TO THE QUESTIONS THAT WE ASK ARE GOING TO GIVE A MUCH BETTER READ NOT JUST E-CIGARETTES BUT ANY TOBACCO PRODUCT FOLKS ARE USING. WE DON'T HAVE TO HAVE REGULAR RATORY AUTHORITY OVER THE PRODUCTS BECAUSE WE CURRENTLY DO NOT HAVE REGULATORY AUTHORITY OVER E-CIGARETTES TO INCLUDE THOSE PRODUCTS IN THE PAST. THE CONCEPT WAS AWARDED TO WEST NET AND NCI ROLE WAS CRITICAL IN -- ON STUDY DESIGN AND INSTRUMENT DEVELOPMENT. COUPLE OF EXAMPLES OF THE COLLABORATIVE RESEARCH ACTIVITIES, THE HEALTH INFORMATION NATIONAL TREND SURVEY, TOBACCO USE SUPPLEMENT TO THE CPS. ONGOING, VERY IMPORTANT PIECES OF INFORMATION, EVERYBODY IS THINKING WHAT IS GOING ON WITH THESE PRODUCTS. LAST BUT NOT LEAST, THE AWARDS WE ANNOUNCED LAST SEPTEMBER FOR THE 14 TOBACCO CENTERS REGULATORY SCIENCE AS WE CALL THEM WITH IMPORTANT CHARACTERISTICS FEATURES. THERE'S GO TO BE DEVELOPMENTAL PILOT RESPONSE, RAPID RESPONSE CAPABILITY BUILT INTO EACH OF THE AWARDS. AND PAM'S IS PERHAPS THE BEST EXAMPLE OF THE NEED FOR THAT RAPID RESPONSE CAPABILITY. SHE RIGHTLY POINTED OUT THAT SOME OF THE LITERATURE WE'RE RELYING ON IN 2014 WAS PUBLISHED IN 2010 WHICH MEANS DATA WAS GATHERED A YEARER TWO BEFORE THAT AND IF WE'RE TALKING E-CIGARETTES ONE REALLY NEED TO ASK HOW RELEVANT PUBLISHED IN 2010 BASED UPON WORK THAT WAS DONE IN 2008, 2009 OR THIRD GENERATION E-CIGARETTES IN THE MARKETPLACE IN 2014. I WHEN TO THE RAPID RESPONSE POSTER SESSION LAST YEAR AND I DIDN'T SEE ANYTHING RAPID THERE. SO WE GOT TO ACCELERATE THE HOW WE'RE GETTING INFORMATION OUT OF THESE AWARDS AND THE RAPID RESPONSE CAPABILITY BUILT INTO THE TCORS IS A NICE EXAMPLE OF THAT. SO 14 GRANTS, UP TO $4 MILLION A YEAR AWARDED $53 MILLION LAST FISCAL YEAR. AND WE BUDGETED FOR UP TO $273 MILLION OVER FIVE YEARS. HERE ARE THE SEVEN OF 14 STUDIES FUNDED THROUGH NCI JUST SO YOU SEE WHO GOT THE MONEY AND WHERE THEY ARE LOCATED. THE OTHER PIECES I WAS ASKED TO TALK ABOUT WAS OUR PRIORITIES AT CENTER FOR DEPARTMENT OF TOBACCO, HIGH LEVEL AND TRY THE LEAVE TIME FOR QUESTIONS. I WANT TO TALK ABOUT WHAT WE CALL SUBSTANTIAL EQUIVALENTS, MENTHOL, THE DEEMING REGULATION, PUBLIC EDUCATION CAMPAIGN, THEN TWO OF THE BIGGEST OPPORTUNITIES THAT I SEE MORE FORWARD LOOKING WAY FOR FDA, PRODUCT STANDARDS AND WHAT I CALL COMPREHENSIVE NICOTINE REGULATORY POLICY. THERE ARE A NUMBER OF PATHWAYS THAT THE LAW ALLOWS NEW PRODUCTS TO COME TO MARKET. COMPANY CAN FILE A MORE ROBUST PRE-MARKET NEW PRODUCT APPLICATION UNDER THAT'S APPROPRIATE FOR PROTECTION OF PUBLIC HEALTH STANDARD OR THE LAW ALLOWS COMPANIES TO SUBMIT A MORE ABBREVIATED APPLICATION, IF THEY CAN DEMONSTRATE THEIR NEW PRODUCT IS SUBSTANTIALLY EQUIVALENT TO WHAT'S THE PREDICATE PRODUCT, A PRODUCT ON THE MARKET AS FEBRUARY 15th 2007, THAT DATE IS SPECIFIED IN THE LAW, FDA DIDN'T CHOOSE IT. IF THE NEW PRODUCT HAS THE SAME CHARACTERISTICS AS THE PREDICATE PRODUCT, THAT IS A BASIS FOR FDA ISSUING ORDER THE NEW PRODUCT IS SUBSTANTIALLY EQUIVALENT. IF THE NEW PRODUCT HAS DIFFERENT CHARACTERISTICS THEN WE HAVE TO GO TO PART TWO AND ANSWER THE QUESTION DO THOSE DIFFERENT CHARACTERISTICS RAISE DIFFERENT QUESTIONS OF PUBLIC HEALTH. WE MADE THE FIRST EVER DECISIONS FOR EITHER WHAT WE CALL SC OR NSE NOT SUBSTANTIALLY EQUIVALENT APPLICATIONS LAST JUNE. THOSE, ALL DECISIONS WE HAVE MADE ON THESE APPLICATIONS UNTIL LAST WEEK WE WORDERRED TOBACCO PRODUCTS SOLD OFF THE MARKET BECAUSE WE DETERMINEDDED THEY WERE NOT SUBSUBSTANTIALLY EQUIVALENT. DON'T NEED TO GO INTO REASONS HERE BUT UNDERSTAND A LITTLE BIT OF HISTORY WAS MADE, REGULATORY HISTORY WAS MADE WHEN A SCIENCE BASED REGULATORY AGENCY MENTHOL. CONGRESS MADE A POLITICAL DECISION WHEN IT PASSED THE FAMILY SMOKING DECISION AND TOBACCO CONTROL TO EXCLUDE MENTHOL FROM THE BAND ON CHARACTERIZING FLAVORS IN CIGARETTES. CONGRESS SAID TO FDA BASICALLY YOU FIGURE OUT WHAT TO DO ABOUT MENTHOL IN CIGARETTES. CONGRESS ORDERED THE AGENCY TO CONVENE OUR TOBACCO PRODUCT SCIENTIFIC ADVISORY COMMITTEE CHAIRED BY DR. SUMMIT AND THEY HAD A DEADLINE TO ISSUE A REPORT TO FDA. QUESTION THEY DID, ALL THAT POINT ALL REQUIREMENTS FOR MEN THAT WILL IN THE LAW ENDED. FROM THE TIME THAT THE ADVISORY COMMITTEES REPORT WAS SUBMITTED TO FDA, THERE WAS THINKING ABOUT WHAT THE REGULATORY OPTIONS MIGHT BE AND LAST JULY WE ANNOUNCED SERIES OF ACTIONS, RELATED TO MENTHOL, ANPRM ADVANCE NOTICE OF PROPOSED RULE MAKING WE PUBLISHED IN ANPRM ASKING SERIOUS OF PROVOCATIVE QUESTIONS REGULATORY STATUS OF MENTHOL SHOULD BE. WE RELEASED THE AGENCY OWN PEER REVIEWED PRELIMINARY SCIENTIFIC EVALUATION OF THE HEALTH EFFECTS OF MENTHOL CIGARETTES. WE ANNOUNCED WE WOULD HE CAN INCLUDE MENTHOL SPECIFIC MESSAGING IN A PUBLIC EDUCATION CAMPAIGN WE'RE GOING TO LAUNCH. AND WE ENCOURAGED THE PUBLIC TO VIGOROUSLY PARTICIPATE IN THE COMMENT PROCESS ON THAT ANPRM AND IN RESPONDING TO PUBLIC RELEASE OF THE AGENCY PRELIMINARY SCIENTIFIC EVALUATION. WE GOT ROBUST PUBLIC PARTICIPATION. THERE WERE ABOUT 175,000 COMMENTS SUBMITTED TO OUR DOCKET, THE DOCKET CLOSED ROUGHLY THANKSGIVING AND WE HAVE BEGUN THE PROCESS OF REVIEWING THOSE COMMENTS. INITIALLY THE GRANT OF AUTHORITY AND THE LAW WAS FDA YOU CAN START REGULATING CIGARETTES. CIGARETTE TOBACCO, ROLL YOUR OWN TOBACCO AND SMOKELESS TOBACCO. THERE WAS A PARALLEL PROVISION IN THE LAW THAT SAYS BY RULE MAKING, YOU CAN DEEM OTHER PRODUCTS THAT MEET STATUTORY DEFINITION OF TOBACCO PRODUCT TO BE WITHIN YOUR REGULATORY REACH BUT YOU CAN ONLY DO THAT THROUGH RULE MAKING. THAT'S WHERE DEEMING COMES FROM BECAUSE DEEM APPEARS IN THE STATUTE. WE KNOW EVERYBODY IS WAITING FOR PUBLICATION OF PROPOSED RULE WHERE WE CAN FINALLY SHARE WITH THE WORLD THE PRODUCTS THAT WE INTEND TO BRING WITHIN REGULATORY REACH AND HOW WE INITIALLY PROPOSE TO REGULATE THEM. THE PROPOSED RULE WAS SUBMITTED TO OMB LAST OCTOBER AND REMAINS UNDER REVIEW AT OMB. LET ME TALK ABOUT E-CIGARETTES HERE BECAUSE THE REGULATORY STATUS OF E-CIGARETTES IS NOT INTUITIVE. IN 2009 FDA TRIED TO TAKEN FORCEMENT ACTION AGAINST E-CIGARETTES DECLARING THEM TO BE UNAPPROVED DRUGS AND DEVICES. AND TRIED TO PROHIBIT IMPORT. ONE OF THE IMPORTERS SUED FDA AND FEDERAL DISTRICT COURT AND APPELLATE COURT BOTH RULEDDED THAT FDA ACTION WAS INAPPROPRIATE BECAUSE THE COURTS INTERPRETATION OF THE DEFINITION OF TOBACCO PRODUCT. SO IT'S COUNTER INTUITIVE. THE QUESTION EARLIER IS THE RIGHT QUESTION. IT'S NICOTINE DELIVERY, WHY ISN'T IT BEING LOOKED AT LIKE OTHER NICOTINE DELIVERY PRODUCTS ON THE MARKET. WHICH IS EXACTLY THE POSITION FDA TOOK IN 2009 AND LOST. THE COURTS RULED, CHANNEL YOUR BEST LEWIS CAROL HERE. THETHE COURTS RULED BECAUSE NICOTINE IN E-CIGARETTES IS DERIVED FROM TOBACCO. THE ONLY WAY TO E-CIGARETTES IN ABSENCE OF A CESSATION PLAN IS UNDER THE TOBACCO AUTHORITIES OF THE LAW THOUGH THERE'S NO TOBACCO IN E-CIGARETTES. >> CAN I ASK, IS THAT TRUE THE NICOTINE IS DERIVE ODE >> CAN YOU TALK LOUDER? Q. IS IT TRUE THAT THE NICOTINE IS DERIVED FROM TOBACCO VERSUS A SYNTHESIS PRODUCT? >> I CAN'T HERE THE END -- >> HE'S ASKING WHETHER THE NICOTINE IS DERIVEDDED FROM TOBACCO IN FACT VERSUS SOME OTHER ROOT. >> NICOTINE IN E-CIGARETTES IS DERIVED FROM TOBACCO. AS IS THE NICOTINE IN GUN PATCH AND LOZENGE. ALL FROM TOBACCO. THE ISSUE IS WHAT CLAIM IS SPONSOR SEEKING TO MAKE FOR IT SO CLARIFY EARLIER SLIDE. FDA REGULATES E-CIGARETTES IF THE SPONSOR WANTS TO MAKE A CESSATION CLAIM. IF SPONSOR WANTS CESSATION CLAIM THEY HAVE TO COME TO OUR CENTER FOR DRUGS AND GO THROUGH THE DRUG APPROVAL PROCESS. IN THE ABSENCE OF A CESSATION CLAIM E-CIGARETTES ARE NOT REGULATED. THAT'S WHY I HAVE CALLED IT THE WILD WILD WEST. IT IS ABSOLUTELY BUYER BEWARE UNTIL WE CAN CREATE THE REGULATORY FRAMEWORK OVER THEM. THE COURT RULED THE REGULATORY FRAMEWORK WE CAN CREATE UNLESS THERE'S CESSATION CLAIM USING TOBACCO AUTHORITIES OF THE LAW. >> SORRY TO INTERRUPT. HAVE YOU VALIDATED THE NICOTINE IN E-CIGARETTES IS IDENTICAL TO THE NICOTINE FROM TOBACCO? >> NO. >> MIGHT BE INTERESTING TO TRY THAT. NICOTINE IS ANTIMER SO CHAI PRO PREPARATIONS WOULD BE REQUIRED TO SEPARATE THE S FORM THAT'S FOUND IN TOBACCO FROM THE R FORM YOU WOULD GET IN A SYNTHESIS. SO ANY SYNTHETIC FORM OF NICOTINE WOULD BE APPARENT. >> IN THE INTEREST OF TIME, PUBLIC EDUCATION CAMPAIGN YOU SAW IN THE EARLIER SLIDE ONE AUTHORITY WE HAVE ONE IMPORTANT AUTHORITIES WE HAVE IS TO EDUCATE. WE HAVE ANNOUNCED AND JUST A FEW WEEKS AGO LAUNCHED A MASSIVE YOUTH CONVENTION CAMPAIGN 12 TO 17-YEAR-OLDS SO THE INITIAL CAMPAIGN IS GENERAL MARKET CAMPAIGN AT ALL AT RISK 12 TO 17-YEAR-OLDS, THERE'S 25 MILLION TEAM, 10 MILLION OF 25 MILLION MEET DETERMINE GRAPH PROFILING FOR AT RISK AT RISK ONE PARTY AWAY WHERE THEY HAVE BEGUN TO SMOKE BUT NOT PROGRESSED TO DEFINITION OF REGULAR SMOKERS. SO THE FIRST CAMPAIGN WE LAUNCHED IS AIMED ATLANTA RISK TEAMS AND THE NEXT YEAR OR TWO COMPANION CAMPAIGNS WILL ROLL OUT ONE AIM THAT RURAL YOUTH GREATEST RISK FOR USING SMOKELESS TOBACCO MULTI-CULTURAL CAMPAIGN AND LGBT CAMPAIGN. WE'RE SPENDINGING A LOT OF MONEY ON THIS. I HOPE YOU DO. BUDGET FIRST YEAR IS $115 MILLION, TO PUT THAT NUMBER IN PERSPECTIVE, THAT'S AS MUCH MONEY TOBACCO INDUSTRY SPENDS ON ALL ADVERTISING MARKETING AND PROMOTION IN FIVE DAYS. THAT'S OUR -- BY GOVERNMENT STANDARDS THIS IS A LARGE CAMPAIGN. WE WILL EVALUATE TO SHOW IT MOVES THE NEEDLE ON ATTITUDES AN BELIEVESSEN OVER TIME ON BEHAVIOR. BUT UNDERSTANDING $115 MILLION IS AND ISN'T IN THE CONTEXT OF INDUSTRY SPENDING. LET ME CLOSE WITH A COUPLE MORE FORWARD-LOOKING NOTIONS. THESE ARE THE KINDS OF OPPORTUNITIES THAT BROUGHT ME BACK TO FDA AFTER BEING OUT OF GOVERNMENT FOR 13 YEARS. WHEN PEOPLE HEARD I WAS COMING BACK SOME WANTED TO SEND ME TO ONE OF YOUR INSTITUTES HERE. FOR EVALUATION. WONDERING WHY WOULD I COME BACK. SOME MAY STILL BE ASKING THAT QUESTION. PRODUCT STANDARDS. THIS IS THE SINGLE MOST POWERFUL TOOL THAT WE HAVE IN THE LAW. THIS IS THE POWER TO PROHIBIT OR RESTRICT THE ALLOWABLE LEVELS OF SUBSTANCES DELIVERED TO THE END USER IN THE PRODUCTS THAT WE REGULATE. I HAVE BEEN STATING PUBLICLY THE BETTER PART OF LAST YEAR WE ARE LOOKING AT THAT TIME POTENTIAL FOR PRODUCT STANDARDS TO REDUCE ADDICTIVENESS TOXICITY AND APPEAL AND SUPPORTING A LOT OF RESEARCH IN THIS AREA TO AS WE EXPLORE WHAT OUR REGULATORY OPTIONS ARE HERE. CONGRESS DEBATED AND P GAVE FDA AUTHORITY THE ISSUE A PRODUCT STANDARD TO RENDER TOBACCO PRODUCTS MINIMALLY ADDICTIVE THROUGH DIRECT REGULATION OF NICOTINE CONTENT OF REGULATED TOBACCO PRODUCTS. THE ONLY LIMITATION ON THAT PARTICULAR AUTHORITY FOR WHATEVER REASON IS WE CANNOT ISSUE A NICOTINE PRODUCT STANDARD AND SET THE LEVEL AT ZERO. AS LONG AS WE DON'T TAKE SOW ROW AS THE NUMBER WE HAVE THE AUTHORITY TO ISSUE A NICOTINE PRODUCT STANDARD AND WE ARE EXPLORING THROUGH RESEARCH AND POLICY CONSIDERATIONS ALL OUR OPTIONS IN EACH OF THESE AREAS. THAT RELATED TO MY FINAL POINT. THAT IS THE OPPORTUNITY, NEED FOR COMPREHENSIVE NICOTINE REGULATORY POLICY NOT JUST FDA BUT HHS WIDE. PUT A COUPLE OF NOTIONS ON THE TABLE SOME MAY FIND PROVOCATIVE AND YOU MAY DISAGREE WITH AND WELCOME THE QUESTIONSND THE COMMENTS. MICHAEL RUSSELL THE LATE MICHAEL RUSSELL IN THE MID 1970s, MICHAEL WHO TRAINED MANY TOP NICOTINE BEHAVIORAL SCIENTISTS RESEARCH AND CLINICIANS TODAY WAS WAY AHEAD OF THIS TIME. IN THE MID 1970s ALL THE PREVIOUSLY SECRET INTERNAL DOCUMENTS SECRET. HE DIDN'T KNOW THAT WHAT THEY KNEW PRIVATELY, ABOUT THE BUSINESS THEY WERE IN. WHAT THEY WERE SAYING PRIVATELY IS THEY WERE IN THE NICOTINE BUSINESS, NOT TOBACCO OR CIGARETTE BUSINESS. IN 1963, THE TOP LAWYER FOR BROWN AND WILLIAMSON, A YEAR BEFORE THE FIRST SURGEON GENERAL'S REPORT A QUARTER CENTURY BEFORE SURGEON GENERAL WAS ABLE TO CONCLUDE THE NICOTINE AND CIGARETTES WAS ADDICTIVE WHICH DIDN'T HAPPEN UNTIL 1988, IN 1963 THE TOP LAWYER FOR BROWN AN P WILLIAMSON, NICOTINE IS ADDICTIVE WE ARE THEN IN THE BUSINESS OF SELLING NICOTINE IN ADDICTIVE DRUG. MICHAEL RUSSELL IN THE MID 1970s WROTE PEOPLE SMOKE FROM THE NICOTINE BUT DIE FROM THE TAR, PROFOUND IN SIMPLICITY. IT WAS TRUE THEN AND STILL TODAY. I'M NOT SAYING IT'S SAFE OR BENIGN. BUT MICHAEL RUSSELL WAS RIGHT. THEY SMOKE FOR THE NICOTINE AND DIE FROM THE TAR. IT IS NOT THE NICOTINE THAT KILLS ONE-HALF OF ALL LONG TERM SMOKERS. NOW THAT FDA IS BACK IN THE BUSINESS OF REGULATING TOBACCO PRODUCTS, AS A REGULATORY MATTER, WE HAVE THE OPPORTUNITY TO CREATE A COMPREHENSIVE REGULATORY POLICY ACROSS THE SPECTRUM OF PRODUCTS IN THIS CASE DEAN DELIVERY PRODUCTS FDA REGULATES. WE HAVE TO ACKNOWLEDGE A CONTINUUM OF NICOTINE DRINKING ARE PRODUCTS WITH DIFFERENT LEVELS OF RISK AT THE INDIVIDUAL LEVEL. IF I'M A PACK DAY SMOKER OTHERWISE UNABLE TO OR UNWILLING TO QUIT, AND I COMPLETELY SUBSTITUTE MY SICK GETS FOR SMOKELESS TOBACCO OR SAY THIS WITH SOME HERESY, UNREGULATED E-CIGARETTE. THAT THEORETICAL PACK A DAY SMOKER UNWILLING TO QUIT IS PROBABLY GOING TO SUBSTANTIALLY REDUCE HIS OR HER RISK IF THERE WAS COMPLETE SUBSTITUTION. THE CHALLENGE IS THAT'S NOT WHERE POLICY GETS MADE. POLICY IS MADE AT THE POPULATION LEVEL AND IT'S ABOUT THE NET IMPACT OF ALL THE BEHAVIORS GOOD, BAD OR OTHERWISE. SO IT'S A LOT MORE COMPLICATED THAN MY THEORETICAL PACK A DAY SMOKER. BUT WE HAVE TO ACKNOWLEDGE DIFFERENT NICOTINE DELIVERY PRODUCTS POSE DIFFERENT LEVELS OF RISKK, HAND AND THAT NOTION OF CONTINUE ONE OR SPECTRUM HAS TO INFORM OUR REGULATORY THINKING ABOUT NICOTINE POLICY. WHAT ARE WE GOING TO DO ABOUT THOSE SMOKERS? WHO ARE UNABLE OR UNWILLING TO QUIT? HOW WE DO IT ON THE TOBACCO SIDE OF THE HOUSE AT FDA NEW PUBLIC HEALTH STANDARD THAT COMPELS INDIVIDUAL LEVEL RISK AND POPULATION LEVEL HARM. COMES DOWN TO TWO KEY QUESTIONS FOR US AS TOBACCO REGULATORS. WE'RE GOING TO BE HAVING CONVERSATIONS WITH OUR DRUG COLLEAGUES WHO REGULATE NICOTINE UNDER THE SAFETY AND EFFICACY STANDARD. FOR US WHO IS USING THE PRODUCTS AND HOW ARE THEY USED? ALL THE CONCERNS THAT YOU HAVE HEARD WHAT'S GOING ON IN THE UNREGULATED MARKET PLACE FOR E-CIGARETTES ARE THE RIGHT CONCERNS TO BE PUTTING ON THE TABLE. BECAUSE I GAVE AN ABSTRACT EXAMPLE OF ONE TYPE OF SMOKER WHO COMPLETELY SUBSTITUTES. BUT IN REALITY, PRODUCTED ARING BEING MARKETED IN WAYS TO ENCOURAGE DUAL USE. SO YOU CAN TAKE A PRODUCT ABSTRACT HARM REDUCING AND IT CAN BECOME HARM INCREASING IF REDUCED HARM PRODUCT BECOMES A BRIDGE TO GET A HEALTH CONCERN SMOKER WHO IS INTERESTED IF IN QUITTING FROM THEIR LAST CIGARETTE TO THE NEXT CIGARETTE THAT'S WHOLE OTHER SET OF BEHAVIORS OUT THERE. OUR JOB AS AING ARE LAYTORS USING THE TOOLS OF REGULATORY SCIENCE TO TRY TO ANSWER THESE TWO QUESTIONS. WHO IS USING THEM AND HOW ARE THEY BEING USED? AND WHAT IS THE NET IMPACT AT A POPULATION LEVEL. THANK YOU VERY MUCH. HAPPY TO APES ANY QUESTIONS. -- TO ANSWER ANY QUESTIONS. >> GREAT. THANKS. [APPLAUSE] >> SO WE NOW ARE HAVE TIME FOR QUESTIONS SPECIFIC TO MYCHEL'S PRESENTATION AND THEN MORE BROADLY. SO I OPEN UP THE FLOOR FOR QUESTIONS. BILL. >> BACK TO THE -- LAP ALMOST >> I GUESS THE QUESTION I HAVE IS IF TOBACCO HAS THESE TWO COMPONENTS, NICOTINE AND CARCINOGENIC COMPONENT, WHEN A COMPANY IS PREPARING NICOTINE FROM TOBACCO HOW DO YOU KNOW THEY'RE NOT CO-PURIFYING OTHER CARCINOGENS IN THE PROCESS, HOW DO YOU ACTUALLY KNOW THIS SUBSTANCE THAT GETS INTO THAT E-CIGARETTE IS PURE NICOTINE OR PURE NICOTINE PLUS 40 OTHER THING? >> IF IT'S A PRODUCT THAT IS NOT CURRENTLY ON THE MARKET, THEY HAVE TO FILE -- THEY CAN'T JUST DO THAT AND MAKE THE CHANGE AND START SELLING THE PRODUCT. THEY HAVE TO FILE AN APPLICATION WITH US. IF THEY THINK CURRENTLY UNMARKETTED PRODUCT IS SUBSTANTIALLY MARCH 15, THEY HAVE TO PROVE IT TO UP IN THEIR APPLICATION. IF THEY WANT IT TO BE IN RECEIPT OF A PRE-MARKET PRODUCT APPLICATION, THEY HAVE TO MEET BROADER FOR APPROPRIATE PROTECTION OF PUBLIC HEALTH STANDARD. IN EITHER CASE THEY HAVE TO GIVE INFORMATION YOU'RE DESCRIBING. ON A PRE-MARKET BASIS. IF THE PRODUCT IS NOT CURRENTLY ON MARKET IT CAN'T COME TO MARKET UNTIL WE ISSUED A EQUIVALENCE ORDER OR NEW PRODUCT ORDER. FROM ANY OTHER QUESTIONS? JENNIFER? >> TERRIFIC PRESENTATION. I THOUGHT YOU HAD MENTHOL UP THERE AS ONE PRIORITY. AND THE RECENT STUDY SOUTHERN IMMUNITY COHORT WHERE WE HAVE THE HIGHEST CANCER DEATH RATE SHOW OUT OF 85,000 PEOPLE FOLLOWED, THOSE THAT SMOKED MENTHOL CIGARETTES SMOKED FEWER AND HAD LOWER INCIDENCE OF LUNG CANCER. HOW IS THAT -- IT SEEMS LIKE A HUGE CONCERN IN SOMETHING THAT FLAVOR SUBSTITUTES BUT ACTUALLY IT TURNED OUT IT WAS FOUND THOSE CIGARETTES NO MORE HARMFUL, PERHAPS LESS. >> MENTHOL IS A COMPLICATED QUESTION, LET ME STATE THE OBVIOUS. IT'S NOT ONLY ABOUT THE DIRECT HEALTH EFFECTS OF MENTHOL. WE DON'T NEED MORE STUDIES TO KNOW THE ROLE IT PLAYS IN INITIATION. IT'S WHY WE HAVE INCLUDED MESSAGING IN THIS PUBLIC EDUCATION CAMPAIGN THAT I ALLUDED TO. THERE ARE QUESTIONS WE HAVE ABOUT MENTHOL WHEN IT COMES TO CESSATION, AND IS IT HARDER TO QUIT AMENTALATED CIGARETTES FROM NON-MENTHOLATED. WE POSED THE QUESTIONS ABOUT WHAT THE REGULATORY STATUS OF WHAT MENTHOL SHOULD BE. I CAN'T COMMENT ON REGULATORY POLICY ISSUES BUT UNDERSTAND THE ISSUES RELATED TO MENTHOL ARE NOT JUST ABOUT DIRECT HEALTH EFFECTS. >> ANY OTHER THOUGHTS? I'M ALSO PLEASED BY PRESENTATION, IT'S GOOD TO HAVE YOU BACK. THROUGHOUT PRESENTATIONS I HAVE HAD THIS IMAGE OF THE WOLF AND THE SHEEP. I PERCEIVE YOU AS A STRONG SHEPHERD SO I APPRECIATE YOUR ROLE HERE. >> THAT'S AWFULLY KIND. I DON'T KNOW HOW MY FLOCK FEELS. P I DON'T KNOW IF I EVEN HAVE A FLOCK. I NEVER SAID THE WORD FLOCK PUBLICLY. SOUNDS BAD. >> ALL RIGHT. SO WE HAVE TIME ON THE AGENCY. WE DID IN FACT PAUSE FOR QUESTIONS AFTER EACH PRESENTATION. THERE MAY OR MAY NOT BE GENERAL COMMENTS OR OTHER POINTS PEOPLE WANT TO MAKE BUT WE HAVE TIME IN THE AGENT TA TO CONSIDER ADDITIONAL THOUGHTS APPROXIMATE COMMENTS JONATHAN. >> ADDITIONAL THOUGHT, ONE OFTENNESS INTERESTING OBSERVATIONS THINKINGN'T THE COMMENTS ABOUT LUNG CANCER NOT BEING ONE DISEASE IS THE 40 YEAR SHIFT IN TYPES OF LUNG CANCER THAT OCCUR. IN THE FALL OF SQUAMOUS CELL, RISE OF ADENOCARSCARCINOMA, THIS IS NICELY COVERED IN THE 2014 REPORT, IS THAT -- WHAT CAN BE LEARNED THERE FROM POINT OF VIEW OF GOOD RESEARCH? PART OF THE PROBLEM IS THE CHANGES HAPPENED. IT'S HARD TO GO BACK. BUT HERE IS A SHIFT IN ONE OF THE MAJOR DISEASES CAUSED BY SMOKING, WE TALK ABOUT CHANGES IN INHALATION, TOBACCO SPECIFIC NITROSE MEAN AND OTHER THINGS BUT CAN WE DO BETTER WITH A PROPERLY FRAMED SET OF RESEARCH? FITS IN THE PROVOCATIVE QUESTIONS REALM. FROM >> CERTAINLY MORE ATTENTION BEING PAID TO MOLECULAR SIGNATURES ASSOCIATED NOT JUST WITH THE GENES MUTATED BUT THE CHANGES FOUND IN DIFFERENT LUNG CANCERS. SO HOW -- >> YOU CAN MAKE SOME DEDUCTIONS FROM THE KINDS OF MUTATIONS THAT MAY OR MAY NOT BE RELATED TO COMPOUNDS PRESENT IN TOBACCO SMOKE. BUT HOW YOU MAKE USE OF THAT CLINICALLY, CLINICIANS PAY ATTENTION TO DISTINCTION BETWEEN TUMORS IN NEVER SMOKERS VERSUS SMOKERS. ONE THING THAT'S COME UP HEAVILY FEATUREED IN THE ARTICLE BY NEW ENGLAND JOURNAL ARTICLE BY THE EFFECT ON REDUCTION IN CANCER THAT OCCUR WHEN PEOPLE GIVE UP SMOKING AT DIFFERENT STAGES, THERE'S A LOT TO BE LEARNED ABOUT WHAT CANCER LOOKS LIKE IN PATIENTS WHO HAVE STOP SMOKING SOME YEARS AGO. MORE ATTENTION NEEDS TO BE PAID TO THE BENEFITS OF STOPPING SMOKING AFTER MANY YEARS, I THINK THERE IS A BARRIER TO CESSATION PEOPLE THINK NOT MUCH TO BE GAINED BY BUT THE FACT IS THE ARTICLE DEMONSTRATE THERE'S A LOT TO BE GAINED BY CESSATION. >> JUST WANT TO MAKE A COMMENT ESPECIALLY ABOUT THE SMOKING CESSATION AND LUNG CANCER. SMOKING CESSATION ALONE IS NOT GOOD ENOUGH. LOOK AT INCIDENCE OF LUNG CANCER BY SMOKING STATUS, IN FACT, 50% LUNG CANCER WE SEE COME FROM FORMER SMOKERS, PEOPLE USE SMOKE, THEY STOP ANOTHER 30%, 35% OF SMOKE -- CURRENT SMOKERS, IF YOU LOOK AT THE LUNG CANCER INCIDENT, 35% COME FROM CURRENT SMOKERS. THEN ANOTHER 15 PERCENT% OF LUNG CANCER COME FROM NON-SMOKERS SO PEOPLE WHO USED TO SMOKE AND IT BECOME FORMER SMOKER, THE AWE DEFINE FORMER SMOKERS IS CESSATION OF SMOKE AT LEAST FOUR MONTHS. I CALL THEM THEY BECOME GOOD CITIZEN. THAT'S GREAT. BUT STILL WE HAVE TO CONTINUE TO MONITOR IN THOSE FORMER SMOKERS. AND I THINK THAT'S EXTREMELY IMPORTANT ESPECIALLY ABOUT THE SCREENING EARLY DETECTION AND PREVENTION IN LUNG CANCER. >> THANK YOU. >> I'M NOT SURE, WE'RE NOT DISAGREEING BECAUSE THE CUMULATIVE BENEFIT EVEN STOPPING SMOKING AFTER 20, 30 YEARS YOU STILL GET THE BENEFIT. >> ABSOLUTELY. >> FORGIVE ME IF YOU COVERED THIS. AND I MISSED IT. CAN ONE OF YOU SPEAK TO HOW THE E-CIGARETTES, AND PRODUCTS ARE BEING TAXED AT THE STATE AND FEDERAL LEVEL AND IS THAT AN IMPORTANT COMPONENT OF THE PRICE THAT WITH CONVENTIONAL TOBACCO PRODUCT? >> >> LEGISLATORS STATE AND LOCAL LEVEL TRYING TO FIGURE THAT OUT AS WE SPEAK. THE TOBACCO CONTROL COMMUNITY IS SPLIT ON THIS IN THE SAME WAY THEY ARE SPLIT ON THE HARM REDUCTION ASPECTS OF E-CIGARETTES. THERE ARE SOME WHO BELIEVE EXCISE TAX POLICIES SHOULD BE BASED UPON PRINCIPLES OF HARM REDUCTION AND THAT THE LAST -- THE LESS HARMFUL PRODUCTS SHOULD BE TAXED LOWER RATE AS INCENTIVE TO GET PEOPLE TO USE THE LESS HARMFUL PRODUCTS. I WOULD SAY THE -- JUST MY TAKE, THE MAJORITY OF THE FOLKS IN THE FIELD DISAGREE WITH THAT AND BELIEVE E-CIGARETTES FOR TAX PURPOSES, FOR CLEAN INDOOR AIR LAW PURPOSES SHOULD BE TREATED IN EXACTLY THE SAME WAY THAT CONVENTIONAL KOMBUING CIGARETTES ARE TREATED SO ONGOING DEBATE AND STATES AND LOCALITIES ARE TRYING TO FIGURE OUT WHAT THE EXCISE TAX POLICY SHOULD BE AND CDC OFFICE ON SMOKING AND HEALTH IS WORKING VERY HARD TO BE A TECHNICAL RESOURCE FOR STATES TRYING TO FIGURE THIS OUT IN REAL TYPE. >> ANY OTHER QUESTIONS OR COMMENTS? IF NOT, THANK YOU TO ALL OF OUR PRESENTERS FROM THIS AFTERNOON AND FROM THIS MORNING. MICHELLE, THANK YOU ESPECIALLY FOR YOUR HELP PUTTING THIS PROGRAM TOGETHER. I PERMLY AND I THINK I SPEAK FOR THE WHOLE OF THE BOARD FOUND IT EXTREMELY INFORMATIVE AND INTERESTING AND OBVIOUSLY EXTREMELY IMPORTANT AS WELL. SO THANKS SO MUCH FOR YOUR CONTRIBUTIONS. [APPLAUSE] BEFORE WE MOVE TO CLOSED SESSION WE NEED TO HEAR FROM THE SUBCOMITTEES WHICH THERE'S ONE TO REPORT AND THAT BILL, ON THE SUBCOMITTEE ON BUDGET AND PLANNING. BILL. >> THANK YOU, I'LL BE FAIRLY BREECH TURN TO ONE OF YOUR LAST WHITE TABS I THINK IT'S CALLED ON GOING NEW BUSINESS WHICH WILL HELP A LITTLE BIT. TO REMIND YOU THIS WAS OUR SECOND MEETING THAT WE HAVE HAD, WE DIDN'T HAVE A MEETING FOR A WHILE BECAUSE WE DIDN'T HAVE A DIRECTIVE. ALSO GOOD NEWS, I ONLY HAVE TWO LEFT ON THE BOARD -- >> SO THERE COULD BE VERY WELL A SUSPENSION BY COMMITTEE OR CERTAINLY PROBABLY A NEW CHAIRMAN. OUR FIRST MEETING WHICH WAS THE LAST MEETING WE HAD A NICE MEETING AND WE HEARD FROM PEOPLE, THE STAFF FROM THE SENATE AND ONE THING THAT CAME OUT OF THAT WAS THAT OUR COMMITTEE WANTED TO KNOW A LOT MORE DETAILS AND PERSPECTIVE WE DID NOT HAVE AND HAROLD HAD AND WE HAD PRIMARILY MOST EVENING SPENT LAST NIGHT WITH HAROLD CHATTING ABOUT I GUESS THE JOURNEY HE'S BEEN ON SINCE HE'S BEEN HERE ON TRYING TO TRADE OFF ON A BUDGET REDUCTION, THAT HAPPENED TO BE WHAT'S CALLED AN ADMINISTRATIVE MEETING SO IT WAS CONFIDENTIAL SO I WON'T REPORT ANY FINDINGS OF THAT COMMITTEE OTHER THAN TO LET YOU KNOW WE DID HAVE A CHAT. QUESTION HAD A SHORT PRESENTATION, TURN TO THE LAST TWO SHEETS, I PULLED A COUPLE OF SLIDES THAT I THINK WILL SUMMARIZE BETTER THAN I MIGHT BE ABLE TO CHAT. $144 MILLION INCREASE AND IT WAS 2.8%. THAT LOOKS BETTER THAN IT IS AND I'LL TRY TO EXPLAIN OF THE $5 MILLION ROUGHLY BUDGET, 1 BILLION OF THAT HAS HALF THE INCREASE THAT'S MANDATORY. SO WHEN YOU TAKE THAT AWAY, THEN THAT CUTS THE OTHER PART WHICH IS $4 BILLION TO ONLY HAVE A $70 MILLION INCREASE. WHEN YOU ADD TO THAT, A LOT OF THINGS RELATED TO MEDICINE HAVE A HIGHER COST INDEX THAN CPI DOES, YOU ARE BACK TO BACK THAT WE PROBABLY ARE EFFECTIVELY GETTING REAL MONEY, CERTAINLY NO MORE THAN WE DID IN PREVIOUS YEARS AND PROBABLY ARE PERCENT OR TWO DOWN, NOT HORRIBLE BUT NOT GOOD, I'LL SKIP THE NEXT CHART AND GO TO THE BACK CHART WHICH I'LL TRY TO SPEND A LITTLE TIME ON, THERE ARE TWO LINES HERE, THIS WAS A COLOR CHART, I APOLOGIZE, BUT IF YOU THINK THE TOP LINE AS BEING AN UNADJUSTED FOR INNATION FUNDING OF THE NCI AND AT LEAST MY GLASSES DON'T HELP ME GET THE ACCESS RIGHT BUT BASICALLY IN 1999 I BELIEVE IT WAS, IT IS ONE LEVEL AND GOES UP WHICH MAKES YOU FEEL GOOD. BUT TAKE THE SECOND LINE, THAT'S INFLATION ADJUSTED. IF YOU LOOK AROUND 2002, IT STARTS DOWNWARD TO WHERE WE ARE NOW. AND THAT'S IS CALCULABLE AT ABOUT A 25% REAL REDUCTION IN DOLLARS, REAL DOLLARS OF VALUE. THAT'S WHAT HAROLD HAS TRIED TO -- HE HAS HAD HIS JOURNEY THROUGH TRYING TO ADJUST TO. LOOK AT THE DOTTED LINE, IT'S GOT A SLIGHT DECREASE BUT BASICALLY IT'S FLAT. SO THAT IS THE FORECAST, DOESN'T MEAN FOR CASTE WILL HAPPEN THE NEXT 7, 8, 10 YEARS BUT FORECAST IS THAT WE WILL PROBABLY BE ROUGHLY A FLAT TYPE BUDGET WITH MAYBE A LITTLE BIT OF INFLATION INCLUDED. SO I'LL END WITH THAT. NOT TRYING TO BE BAD NEWS, ACTUALLY THOUGHT THIS WAS GOOD NEWS, ANYTHING HEADED DOWN AND LEVELS OFF IS GOOD. SO I THINK IT'S GREAT WE BELIEVE IT'S GOING TO BE FLAT. BUT EVEN BETTER NEWS WOULD BE IF IT COULD HEAD UP A LITTLE BIT. SO THAT'S MY REPORT. >> THANK YOU, BILL. WE NEED A MOTION TO ACCEPT THAT REPORT. SECONDED. ALL IN FAVOR. MOTION PASSES. TERRIFIC. ANY ADDITIONAL BUSINESS OR SUGGESTIONS FOR AGENDA ITEMS FOR FUTURE MEETINGS? WE TALKED ABOUT THAT ALREADY. I SEE NONE. IF YOU HAVE ADDITIONAL ONES FORWARD THEM ON TO ME OR TO PAULETTE. WITH THAT, I WOULD LIKE TO BRING THE OPEN SESSION TO A CLOSE. ASK OUR GUESTS TO DEPART, THANKS AGAIN TO EVERYONE WHO PRESENTED TODAY. AND WE'LL TAKE A SHORT BREAK, A FIVE-MINUTE BREAK TO ORGANIZE OURSELVES AND WE'LL RESUME AT 3 O'CLOCK.