>> GOOD AFTERNOON. MY NAME IS DAVE NELSON. IT'S MY DISTINCT PLEASURE TO WELCOME YOU TO THE 2013 ANNUAL ADVANCES IN CANCER PREVENTION LECTURE TOUR. OUR SPEAKER WITH DR. DIANA PETITTI. I DON'T WANT TO CUT INTO HER TIME BECAUSE HER PRESENTATION, WHICH IS ON THE INTERSECTION OF SCIENCE, POLITICS AND POLICY, I THINK WILL BE FASCINATING FOR YOU. A LITTLE BIT OF BACKGROUND ABOUT DR. PETITTI. SHE'S WORKED IN SEVERAL DIFFERENT SECTORS INCLUDING A COUPLE DIFFERENT UNIVERSITIES. SHE WAS AT KAISER PERMANENTE IN SOUTHERN CALIFORNIA AND NORTHERN CALIFORNIA FOR A NUMBER OF YEARS. SHE'S CURRENTLY IN A POSITION AT ARIZONA STATE UNIVERSITY. HER BACKGROUND IS QUITE DISTINGUISHED IN MANY AREAS. MORE THAN 200 PUBLICATIONS IN JOURNALS, THE AUTHOR OF A COUPLE DIFFERENT BOOKS ON DIFFERENT TOPICS, SHE SERVED ON NUMEROUS NATIONAL AND INTERNATIONAL COMMITTEES. SHE WAS THE VICE CHAIR OF THE UNITED STATES PREVENTIVE SERVICES TASK FORCE FROM 2003 TO 2009, WHERE SHE'LL BE RELATING TO YOU SOME OF THE EXPERIENCES INVOLVED WITH THAT. WITHOUT ANY FURTHER ADO, I'LL WELCOME TO YOU, DR. DIANA PETITTI. [APPLAUSE] >> WELL, I'M REALLY PRIVILEGED TO BE HERE TODAY AND WANT TO THANK DAVE NELSON FOR ASKING ME, ALTHOUGH I HAVE TO SAY THAT THESE ARE THE KINDS OF TALKS THAT MAKE ME EXTREMELY NERVOUS, OKAY? I'D MUCH RATHER BE TALKING ABOUT SOME CASE CONTROL STUDY THAT I DID AND PRESENTING A SET OF FACTS THAT I CONSIDER TO BE FACTS, BUT TODAY WHAT I'M GOING TO BE DOING IS TALKING ABOUT MY EXPERIENCES AS A MEMBER OF THE U.S. PREVENTIVE SERVICES TASK FORCE IN 2009, AS THE DESIGNATED SPOKESPERSON FOR MAMMOGRAPHY SCREENING GUIDELINES THAT TURNED OUT TO CREATE A POLITICAL FIRESTORM AND TO BE WAY MORE CONTROVERSIAL THAN I THOUGHT THEY SHOULD HAVE BEEN. THIS SLIDE IS NOT AN ATTEMPT TO PROMOTE CIGARETTE SMOKING AND I WANT TO APOLOGIZE TO MR. EASTWOOD FOR TAKING HIS IMAGE FROM THE INTERNET, THIS IS A COPYRIGHTED IMAGE, I'LL I TRIED TO GET THE SOUND CLIP IN, I THINK THE HAUNTING BACKGROUND FOR THIS MOVIE SORT OF SAYS SOMETHING LIKE WHAT IT'S LIKE TO GO THROUGH AN EXPERIENCE LIKE THIS AT THE CENTER OF CONTROVERSY OF SCIENCE IN A HIGHLY CHARGED POLITICAL ENVIRONMENT. NOW I'M GOING TO TALK ABOUT THE U.S. PREVENTIVE SERVICES TASK FORCE, A LITTLE BIT ABOUT HOW IT DOES ITS WORK AND THEN GET INTO SOME OF THE PERSONAL EXPERIENCES AND THE ISSUES RAISED WHEN THE TASK FORCE ISSUED ITS 2009 RECOMMENDATION ABOUT SCREENING MAMMOGRAPHY. MANY PEOPLE DON'T UNDERSTAND THAT THE TASK FORCE STARTED OFF REALLY AS AN INDEPENDENT ADVISORY GROUP OF PHYSICIANS MOSTLY, IN FACT, ALMOST SOLELY, GATHERING TOGETHER TO FOLLOW THE MODEL OF THE CANADIAN TASK FORCE ON THE PERIODIC HEALTH EXAM IN ORDER TO PROVIDE INFORMATION TO PRACTICING PHYSICIANS ABOUT WHAT THE CONTENT SHOULD BE OF A ROUTINE HEALTH PHYSICAL. THE TASK FORCE ACTUALLY PUBLISHED IN -- IT WAS ACTUALLY OFFICIALLY COMMISSIONED BY THE PUBLIC HEALTH SERVICE IN 1984 AND IN 1989, IT ISSUED A GUIDE TO CLINICAL PREVENTIVE SERVICES THAT BECAME TO SOME EXTENT A MODEL FOR THE APPLICATION OF THE PRINCIPLES OF EVIDENCE-BASED MEDICINE TO ADVICE TO PHYSICIANS ABOUT WHAT THEY SHOULD AND SHOULDN'T BE DOING IN THEIR PRACTICES. IN 1990 TO 1994, THERE WAS -- THE COUNCIL MET ON A REGULAR BASIS AND IT ISSUED A SECOND SET OF RECOMMENDATIONS, THE UPDATED GUIDE IN 1996, AND IN 1998, THE THIRD TASK FORCE WAS COMMISSIONED AND IT WAS GIVEN A RELATIONSHIP WITH THE AGENCY FOR HEALTHCARE RESEARCH AND QUALITY THAT WAS DESIGNED TO PROVIDE ONGOING PROFESSIONAL SUPPORT FOR THE WORK OF THE TASK FORCE. IN 2001, IT BECAME A STANDING COMMITTEE, WHICH IS WHAT WE NOW CALL -- I'M GOING TO CALL IT THE TASK FORCE MEANING U.S. PREVENTIVE TASK FORCE BECAUSE SOMETIMES I STUMBLE ON THOSE WORDS. I'M NOT GOING TO READ THIS TO YOU BUT I'LL LET YOU READ THE SLIDE WHICH IS FROM A BILL WHICH AUTHORIZED THE TASK FORCE TO THE DIRECTOR OF HEALTH AND HUMAN SERVICES TO CONVENE A TASK FORCE TO CONVENE AUTOMATICALLY IN ORDER TO REVIEW SCIENTIFIC EVIDENCE RELATED TO THE EFFECTIVENESS, APPROPRIATENESS AND COST-EFFECTIVENESS OF CLINICAL PREVENTIVE SERVICES FOR DEVELOPING RECOMMENDATIONS. THIS IS HOW THE TASK FORCE DOES ITS WORK. I'M GOING TO BE BRIEF ABOUT THIS BECAUSE I'D LIKE TO GET TO THE SUBSTANCE OF THIS ISSUE AND MAKE SURE THAT WE HAVE PLENTY OF TIME FOR QUESTIONS. THERE WILL BE A 15-MINUTE QUESTION AND ANSWER PERIOD AT THE END SO THAT WE CAN HAVE SOMETHING OF A DISCUSSION AS MUCH AS WE CAN IN THIS KIND OF FORUM. THE TASK FORCE CONDUCTS SYSTEMATIC REVIEW -- OR COMMISSIONS THE CONDUCT OF SYSTEMATIC REVIEWS OF HARMS AND BENEFITS IN ORDER TO DEVELOP RECOMMENDATIONS FOR CLINICAL PREVENTIVE SERVICES. NOW THE TARGET AUDIENCE FOR THE RECOMMENDATIONS HAS HISTORICALLY AND IN ITS OWN SET OF METHODS BEEN PRIMARY CARE PRACTICE. BUT OVER TIME, THE WORK OF THE TASK FORCE BECAME WIDELY USE BID CONSUMERS AND INSURERS AND THE GOVERNMENT AS THE BASIS FOR DECISIONS ABOUT COVERAGE AND DEPLOYMENT OF CLINICAL PREVENTIVE SERVICES. THIS HAS BOTH BEEN A GIFT AND A CURSE. NOW IN 2009, THE TASK FORCE ISSUED A SET OF UPDATED MAMMOGRAPHY RECOMMENDS. THE TASK FORCE HAD CONSIDERED THE TOPIC OF MAMMOGRAPHY SCREENING IN 2001 AND HAD ISSUED RECOMMENDATIONS TO SCREEN WOMEN OVER 40, QUOTE, EVERY ONE TO TWO YEARS, AND THAT'S -- AND THE RECOMMENDATION IS QUITE VAGUE. THERE HAD BEEN A GREAT DEAL OF ACTUALLY CRITICISM OF THE TASK FORCE FOR NOT BEING MORE SPECIFIC IN SPECIFYING A SPECIFIC STARTING AND ENDING AGE FOR MAMMOGRAPHY SCREENING IN ADDITION TO A VARIETY OF OTHER SCREENING TESTS, AND THE TASK FORCE ATTEMPTED TO BE MORE SPECIFIC IN TAILORING ITS RECOMMENDATIONS AND SAYING THAT MAMMOGRAPHY SHOULD BE DONE EVERY OTHER YEAR IN WOMEN 50 TO 74, AND THEN -- AND THIS IS THE REALLY CONTROVERSIAL PART OF THIS RECOMMENDATION, THAT THE DECISION TO START SCREENING BEFORE THE AGE OF 50 SHOULD BE AN INDIVIDUALIZED DECISION, TAKING INTO ACCOUNT PREFERENCES AND THE CONTEXT. AGAIN, THIS IS WHAT I THOUGHT WAS GOING TO BE THE CONTROVERSIAL PART OF THIS RECOMMENDATION, WHICH WAS A STATEMENT THAT THE EVIDENCE TO SUPPORT SCREENING WOMEN ABOVE THE AGE OF 7 75 WAS INSUFFICIENT TO MAKE ANY KIND OF RECOMMENDATION TO SCREEN OR NOT TO SCREEN. I TURNED OUT TO BE REALLY QUITE WRONG. NOW IT'S IMPORTANT TO UNDERSTAND THAT BY THE RULES OF EVIDENCE OF THE TASK FORCE, WHICH ARE WRITTEN RULES WHICH HAVE BEEN WIDELY PUBLISHED IN THE ANNALS OF INTERNAL MEDICINE AND ELSEWHERE, THE DECISION ABOUT BENEFIT, THE MAGNITUDE OF NET BENEFIT, AND THE CERTAINTY OF EVIDENCE ABOUT THAT NET BENEFIT IS LINKED TO A LETTER GRADE, AND LIKE LETTER GRADES IN SCHOOL, A, B, C, D, A IS THE BEST, THAT MEANS YOU OUGHT TO DO IT, D MEANS THE EVIDENCE IS -- THERE'S EITHER NO BENEFIT OR A NEGATIVE BENEFIT OR HARMS OUTWEIGH BENEFITS AND/OR THERE'S A GREAT CERTAINTY. I'M NOT GOING TO READ THIS BUT THE IMPORTANT PART OF THIS IS THESE LETTER GRADES ARE LINKED TO SPECIFIC ADVICE ABOUT WHAT A CLINICIAN SHOULD DO BASED ON THE LETTER GRADE. NOW THERE'S A BIG DIFFERENCE BETWEEN SYNTHESIZING EVIDENCE, CONDUCTING A SYSTEMATIC REVIEW, AND DECIDING WHETHER OR NOT THE HARPHARMS OUTWEIGH THE BENEFITS, IN ORDER THAT YOU CAN COME UP WITH A QUANTITATIVE ASSESSMENT OF HARMS AND BENEFITS AND DECIDING HOW YOU USE THAT INFORMATION IN ORDER TO SAY WHAT PEOPLE SHOULD DO. THIS IS AN ATTEMPT TO MAP THE GRADES AND THE INFORMATION ABOUT THE MAGNITUDE OF BENEFITS AND HARM AND THE CERTAINTY TO A SPECIFIC SET OF STATEMENTS ABOUT WHAT PEOPLE SHOULD DO. NOW I'M GOING TO GET TO THE PART OF THE TALK THAT IS MY SORT OF FRAMING TALK, THE SCIENCE, THE POLICY, THE POLITICS. I'M A SCIENTIST. I HAVE GOTTEN INVOLVED IN POLICY ISSUES. I AVOID POLITICS LIKE THE PLAGUE, BUT I'M GOING TO TALK ABOUT THE SCIENCE FOR MAMMOGRAPHY. I ACTUALLY THINK THAT THERE'S A LOT OF SCIENCE ABOUT MA'A MAMMOGRAPHY AND MAMMOGRAPHY SCREENING. THIS GIVES YOU AN IDEA OF HOW MANY ARTICLES YOU WOULD HAVE TO READ IF YOU STARTED READING EVERYTHING EVER WRITTEN ABOUT MAMMOGRAPHY. FOR MAMMOGRAPHY, IN FACT, THERE'S ACTUALLY QUITE A LOT OF GOOD SCIENCE, SCIENCE WITH HIGHLY RIGOROUS DESIGN, TO INFORM OUR OPINION AND OUR CONCLUSION ABOUT WHETHER OR NOT MAMMOGRAPHY HAS A BENEFIT AND WHAT THE BENEFITS MIGHT BE. FOR MAMMOGRAPHY, BREAST CANCER SCREENING WITH MAMMOGRAPHY, THERE ARE EITHER NINE OR 10, DEPENDING HOW YOU COUNT THEM, RANDOMIZED CLINICAL TRIALS INVOLVING MORE THAN 600,000 WOMEN AND I PROVIDE SOME REFERENCES -- A TALK WILL BE POSTED ON THE WEB, I HAVE A LIST OF REFERENCES FOR THOSE WHO WANT TO GO IN MORE DEPTH ON THIS TOPIC IF YOU DON'T ALREADY KNOW THIS TOPIC. BY CONTRAST FOR PROSTATE CANCER SCREENING AND PSA, THERE ARE FIVE TRIALS WITH ABOUT -- WITH 341,342 PEOPLE, MEN, ACTUALLY, AND YOU CAN SEE THAT THE COLORECTAL CANCER, THERE ARE ABOUT 500,000, BUT MAMMOGRAPHY BY FAR HAS THE MOST TRIALS AND THE MOST PEOPLE INVOLVED IN THOSE TRIALS. I'M NOT GOING TO READ THIS SLIDE, I DON'T BELIEVE THAT YOU HAVE TO READ EVERY SLIDE YOU PRESENT, BUT THIS GIVES A SYNTHESIS FROM A REVIEW DONE AFTER THE TASK FORCE REVIEW FOR WOMEN 50 TO 69 THAT REALLY SHOWS THAT ACROSS MANY PUBLICATIONS AND MANY GROUPS REVIEWING THE EVIDENCE, THE GOOD SCIENCE IS CONSISTENT. THAT IS, THE RANDOMIZED CLINICAL TRIALS COME UP CONSISTENTLY WITH AN ESTIMATE -- IN WOMEN THIS AGE GROUP IS ABOUT .85 OR ABOUT A 15% REDUCTION. NOW IN MAKING SCIENCE BASED RECOMMENDATIONS ABOUT AGE AND INTERVAL, IN FACT THERE ARE NO TRIALS THAT RANDOMIZE WOMEN TO ONE OR ANOTHER SCREENING INTERVAL OR TO ONE OR ANOTHER AGE TO START SCREENING. IN FACT, THESE TRIALS, SUCH TRIALS WOULD BE EXTREMELY DIFFICULT TO DO AND THEY HAVEN'T BEEN DONE. IN 2009, IN TRYING TO COME UP WITH A SYNTHESIS THAT WOULD HELP TO FURTHER TAILOR RECOMMENDATIONS ABOUT MAMMOGRAPHY SCREENINGS, AGE TO BEGIN, AGE TO END AND INTERVAL, THE TASK FORCE REVIEWED MORE THAN 2,500 STUDIES AND ISSUED AN 89 HA89-PAGE REPORT. IT INCORPORATED INTO THIS REVIEW NEW INFORMATION FROM TRIALS THAT HAD BEEN COMPLETED SINCE THE REVIEW IN 2001 AND IT TOOK INTO ACCOUNT EVIDENCE ABOUT THE HARMS OF SCREENING, RADIATION EXPOSURE, PAIN, ADVERSE RESPONSES TO FALSE POSITIVE MAMMOGRAMS, OVERDIAGNOSIS, THE NEED FOR ADDITIONAL IMAGING AND BIOPSIES WHEN WOMEN HAD A POSITIVE SCREENING MAMMOGRAM FROM THE BREAST CANCER SURVEILLANCE PROGRAM AND ALSO IT TOOK INTO ACCOUNT INFORMATION FROM A MODELING EXERCISE DONE FUNDED BY THE NATIONAL CANCER INSTITUTE THAT ATTEMPTED TO COME UP WITH AN OVERALL ASSESSMENT OF THE HARMS AND BENEFITS. AND THE RECOMMENDATIONS WERE THAT -- THE CONCLUSIONS WERE THAT THERE WAS A DOCUMENTED BENEFIT FROM RANDOMIZED TRIALS FOR WOMEN BETWEEN THE AGE OF 40 AND 74, BUT THE NET EFFECT, THE HARM MINUS THE BENEFIT, DEPENDED MAINLY ON AGE, AS FACTORS THAT WERE MEASURABLE IN THE TRIAL. SCREENING AT SHORTER INTERVALS INCREASES BENEFITS, BUT SCREENING AT SHORTER INTERVAL ALSO INCREASES HARM, SCREENING AT AN EARLIER AGE HAS -- WE'LL TALK A LITTLE BIT MORE ABOUT THAT AS I GO ALONG. A PROMINENT INPUT TO THE U.S. PREVENTIVE SERVICES TASK FORCE 2009 RECOMMENDATION WAS DATA FROM THE CANCER INTERVENTION AND MODELING NETWORK PROJECT, WHICH WAS A FORMAL ATTEMPT TO PUT TOGETHER AND SYNTHESIZE EVIDENCE FROM BOTH TRIALS AND NON-TRIAL SOURCES IN ORDER TO ESTIMATE THE MAGNITUDE OF THE TRADEOFF OF BENEFITS AND HARM. THE MODELING GROUPS CAME FROM DIFFERENT PLACES. THESE ARE PEOPLE WHO REALLY DEVOTED THEIR LIFE TO TRYING TO DEVELOP AN ABILITY TO ASSESS BENEFITS AND HARM AND HYPOTHETICALLY WHAT TREATMENTS AND INTERVENTIONS MIGHT DO TO THOSE BENEFITS AND HARMS FOR BREAST CANCER SCREENING. IT'S FUNDED BY THE NATIONAL CANCER INSTITUTE AND HAD BEEN FUNDED FOR A DECADE BEFORE THE TASK FORCE DECIDED TO USE THE INFORMATION FROM THAT GROUP'S WORK IN MAKING ITS RECOMMENDATIONS. NOW MODELS ARE -- THEY TEST STRATEGIES OR ASSESS STRATEGIES WHERE RANDOMIZED TRIALS AREN'T FEASIBLE. THEY ASK WHAT IF QUESTIONS. MULTIPLE MODELS ACTUALLY, WHEN DONE INDEPENDENTLY BY DIFFERENT GROUPS, BASED ON DIFFERENT ASSUMPTIONS, CAN BE USED TO ACTUALLY ATTEMPT TO SEE WHAT IS THE CONVERGENCE OF CONCLUSIONS BASED ON DIFFERENT SETS OF ASSUMPTIONS, AND INDEED, I THINK ONE OF THE MOST IMPORTANT FACTS THAT WAS LOST IN THE DISCUSSION ABOUT MAMMOGRAPHY SCREENING IS THE DEGREE TO WHICH DIFFERENT MODELERS STRATEGIES AND ASSUMPTIONS CAME UP WITH THE SAME OVERALL CONCLUSION ABOUT THE TRADEOFFS OF RISKS AND BENEFITS COMPARING AN EARLIER VERSUS THE LATER STARTING AGE AND A FREQUENT VERSUS LESS FREQUENT SCREENING INTERVAL. NOW MODELS ACTUALLY INFORM PRACTICE AND POLICY DEBATE, THEY DON'T DICTATE IN ANY WAY WHAT SHOULD BE DONE ANY MORE THAN ANY SINGLE RANDOMIZED TRIAL OR EVEN ANY GROUP OF RANDOMIZED TRIALS EVEN WHEN CONSISTENT DICTATE POLICY DECISIONS. THE ACTUAL MODELING STUDY LOOKED AT THE PERCENT REDUCTION IN BREAST CANCER MORTALITY, THE LIFE YEARS GAINED PER THOUSAND YEARS, AND THEN IT ALSO ADDED -- LOOKED AT ADDITIONAL CHANGE WHERE PEOPLE ARE SCREENING AT YOUNGER AGES COMPARED TO OLDER AGES. IT LOOKED AS THE TRAITOFF, ON THE FLIP SIDE OF THE BENEFIT OF MAMMOGRAPHY, IT LOOKED AT HOW MANY MAMMOGRAMS YOU WOULD HAVE TO DONO DO IN ORDER TO ACHIEVE THAT BENEFIT, THE NUMBER OF SCREENS, THE FALSE POSITIVE SCREENS, THE NUMBER OF UNNECESSARY BIOPSIES, THE DETECTION OF TEU NORS NEVER DESTINED TO CAUSE BREAST CANCER DEATH OR OVERDIAGNOSIS. I THINK THIS IS ONE OF THE BIG LEARNINGS FOR THE PUBLIC, WHICH IS THE BASE CASE. IF WE ELIMINATED MAMMOGRAPHY SCREENING ENTIRELY, YOU COULD NO LONGER GET ACCESS TO A MAMMOGRAPHIC MACHINE, YOU COULD NEVER SCREEN FOR BREAST CANCER, HOW MANY WOMEN ALIVE IN 2009 AT A AGE 40 WOULD BE EXPECTED TO DIE OF BREAST CANCER IF THEY HAD NO MAMMOGRAPHY AND THAT NUMBER IS 3%. WHEN WOMEN HAVE BEEN ASKED TO MAKE THEIR OWN ESTIMATES WITHOUT DATA OF WHAT THAT NUMBER MIGHT BE, THE PERCENTAGES THAT WOMEN ESTIMATE ARE WILDLY HIGHER THAN THE 3% REALITY OF THE PROBABILITY OF ULTIMATELY DYING OF BREAST CANCER ENTIRELY IN THE ABSENCE OF SCREENING. WOMEN WILL SAY 30%. OR 20% OR 50%. THIS IS NOT TO IN ANY WAY DIMINISH THE IMPORTANCE OF BREAST CANCER AS A CONDITION AFFECTING WOMEN, BUT THE MAGNITUDE OF THE RISK OF DYING OF BREAST CANCER S, GIVEN MODERN TREATMENT, IS NOT NEARLY AS HIGH AS MOST WOMEN THINK IT IS. BEN FINTS OF MAMMOGRAPHY CAN ONLY BE FRAMED IN TERMS OF THE ABSOLUTE MAGNITUDE OF THE EVENT TO BE AVOIDED. I JUST PUT THIS IN DIFFERENT WAYS BECAUSE I HAD TO DEAL WITH THE PRESS A LOT AND SOME PEOPLE DON'T UNDERSTAND THE CONCEPT OF 3%. IT'S AMAZING HOW MANY PEOPLE DON'T UNDERSTAND PERCENTAGES. SO THE NUMBERS ARE PUT IN BUMMERS PER THOUSAND. NOW THE NUMBER OF LIFE YEARS LOST DUE TO BREAST CANCER FOR A THOUSAND WOMEN WHO UNDERGO NO MAMMOGRAPHY IS 328. NOW REMEMBER A THOUSAND WOMEN WHO ARE 40 YEARS OLD ARE LIKELY TO LIVE TO BE 86. SO THE ULTIMATE NUMBER OF LIFE YEARS ON THE TABLE IS EQUAL TO 40 TIMES A THOUSAND. THIS SLIDE, I HAVE A DIFFERENT WAY OF PRESENTING THIS SLIDE SO I'LL NOT HAVE YOU READ EVERY -- THIS IS THE KIND OF INFORMATION THAT THE TASK FORCE USED WHEN TRYING TO COME UP WITH A RECOMMENDATION. IN THE ROWS ARE DIFFERENT STRATEGIES OF SCREENING. BIANNUAL SCREENING VERSUS ANNUAL SCREENING, THEIR JUST STARTING AGES AND ENDING AGES, AND IN THIS SLIDE, ALL OF THE ENDING AGES ARE 69, IT SHOWS DIFFERENT STARTING AGES, 40, 45, 50, 55, 60. FOR BIANNUAL VERSUS ANNUAL, IT SHOWS THE NUMBER OF SCREENS PER WOMAN, THE MORTALITY REDUCTION FROM THAT SCREENING STRATEGY COMPARED WITH NO SCREENING, THE LIFE YEARS GAINED, THE DEATHS PREVENTED, UNNECESSARY BIOPSIES AND THEN AN ESTIMATE OF OVERDIAGNOSIS. THE TASK FOR ACTUALLY FOCUSED ON THE STRATEGIES THAT ARE CIRCLED. THAT IS BIANNUAL SCREENING STARTING AT 40 VERSUS BIA ANNUAL SCREENING STARTING AT 50, VERSUS ANNUAL SCREENING STARTED AT 40 VERSUS ANNUAL SCREENING STARTING AT 50, BUT THERE ARE A VARIETY OF OTHER TRADEOFFS AND I THINK YOU CAN SEE THAT THERE ARE ALWAYS TRADEOFFS. DOING SOMETHING -- DOING MORE OF SOMETHING LIKE SCREENING WILL HAVE MORE BENEFITS. IT WILL ALSO HAVE MORE HARM. AND THE DECISION ABOUT WHAT SHOULD OR SHOULDN'T BE RECOMMENDED IS INHERENTLY A TRADEOFF OF THOSE BENEFITS AND HARMS AND INVOLVE JUDGEMENT. I THOUGHT THIS WAS KIND OF A BETTER WAY TO PRESENT THE DATA. BUT I ONLY LEARNED THAT AFTER I TRIED TO GO THROUGH THAT TABLE WITH ABOUT 15 DIFFERENT REPORTERS, ALL OF WHOM WERE QUITE SOPHISTICATED BUT WHO COULDN'T KIND OF COG NATE THAT MANY NUMBERS. I REALIZED THAT I WAS HAVING A HARD TIME EXPLAINING TABLES THAT COMPLICATED TO PEOPLE WHO ACTUALLY WERE TRYING VERY HARD TO UNDERSTAND THE TABLES. SO THIS ACTUA ACTUALLY SHOWS THE TRADEOFFS MORE STARKLY, AND IT SHOWS THAT -- LOOKED AT ANOTHER WAY, FOR WOMEN NOW 40, A THOUSAND WOMEN NOW 40, 30 OF THEM WILL BE EXPECTED TO DIE OF BREAST CANCER WITH NO SCREENING. AND THAT, IN FACT, IF YOU START SCREENING AT AGE 40 AND YOU SCREEN ANNUALLY UNTIL AGE 69, THERE WILL BE 22 BREAST CANCER DEATHS. SO YOU'RE PREVENTING ONLY EIGHT OF THE 30 BREAST CANCER PATIENTS. THIS IS ACTUALLY A BIG REVELATION FOR MANY PEOPLE WHO THINK THAT BREAST CANCER SCREENING IS DONE PERFECTLY, TARTING AT AGE 40 AND ANNUALLY, WILL IN FACT PREVENT MOST BREAST CANCER, BUT IN REALITY, THERE'S STILL A FAIR NUMBER OF BREAST CANCER DEATHS. YOU CAN SEE THAT THE, QUOTE, COST, AND I HESITATE TO USE THE WORD COST BECAUSE COST IMPLIES MONEY, BUT THE TRADEOFF IS DOING 23,600 MAMMOGRAMS, YOU'LL HAVE 2,250 POSITIVE SCREENS, MEANING FOR EVERY THOUSAND WOMEN SCREENED, 2,250 SCREENS WILL BE POSITIVE, WHICH MEANS THAT ON AVERAGE, EVERY WOMAN WILL HAVE TWO POSITIVE SCREENS. AND THERE WILL BE 158 UNNECESSARY BIOPSIES, NOT A BIG NUMBER BUT STILL SOMETHING TO BE TAKEN INTO ACCOUNT. AND YOU GAIN 164 LIFE YEARS AT A THOUSAND WOMEN. NOW THAT'S TRADED OFF AGAINST ANNUAL SCREENINGS, WHERE YOU PREVENT 23 DEATHS INSTEAD OF 22. YOU ONLY DO 17,000 MAMMOGRAMS. YOU ONLY HAVE 1,350 POSITIVE MAMMOGRAMS. AND 95 UNNECESSARY BIOPSIES AND YOU GAIN 132 IB STEA 132 INSTEAD OF 164 LI FE YEARS. NOW IF YOU LOOK AT THE VERY LAST COLUMN, WHICH ACTUALLY IS STARTING SCREENING AT 40 -- AT 50, AND SCREEBIN SCREENING ABOUT THE BIANN UALLY, YOU SEE YOU GO FROM 22 DEATHS TO 25 DEATHS, SO YOU LOSE THREE DEATHS, YOU CAUSE THREE DEATHS, YOU GIVE UP THE POSSIBILITY OF PREVENTING THREE DEATHS. AND YOU GIVE UP ABOUT 65 LIFE YEARS. MY BIG SURPRISE IN BEING INVOLVED IN THIS ISSUE WAS NOT WHETHER OR NOT YOU SHOULD START AT 40 VERSUS 50, BUT WHETHER OR NOT SCREENING SHOULD BE ANNUAL VERSUS BIANNUAL. WHEN I LOOK AT THE NUMBERS, I WOULD HAVE BEEN MORE, QUOTE, UPSET ABOUT THE RECOMMENDATION TO SCREEN BIANNUALLY RATHER THAN ANNUALLY, RATHER THAN THE RECOMMENDATION TO THINK A LITTLE BIT HARDER ABOUT STARTING AT 40 COMPARED WITH A LATER AGE. SO IN FACT, IN MY OPINION, IN MUCH OF THE PUBLIC DEBATE, THE ISSUE OF THE AGE TO START SCREENING AND THE ISSUE OF BREAST CANCER IN WOMEN 40 TO 50 HAS TAKEN HOLD OF THE AMERICAN PUBLIC AND THE MEDICAL COMMUNITY IN A WAY THAT IS NOT REFLECTIVE OF THE DATA. AND THE ISSUE. IT IS, IN MY OPINION, PHARMOEMOTIONAL THAN IT IS OBJECTIVE BASED ON THE FACTS. BUT I SHOULD SAY AT THE END OF THIS TALK, I'M GOING TO SAY IT'S TRUE FOR ALMOST ALL ISSUES RELATING TO SCREEN SCREENING MAMMOGRAPHY. THIS WAS THE ACTUAL SLIDE FROM THE ANNALS OF INTERNAL MEDICINE ARTICLE AND IT SHOWS THE SAME THING, IT SHOWS IT FOR NOT JUST THE MODEL S, WHICH WOULD SERVE AS THE MAIN PUBLICATION FOR THAT MODELING GROUP, BUT ACROSS ALL OF THE MODELS, AND I THINK THE THING THAT'S IMPORTANT ABOUT THIS, AND IT GOES TO THE ISSUE OF MODELING, IS THE NOTION OF CONVERGENT VALIDITY. YOU CAN SEE EACH OF THE MODELS COMES UP WITH A SIMILAR CONCLUSION, WHICH IS THE TRADEOFF THAT IS THE NUMBER OF EXTRA BREAST CANCER DEATHS ASSERTED IS ABOUT THE SAME ACROSS ALL THE MODELS, AND THERE'S NOT A GREAT DEAL OF DIFFERENCE IN THE NUMBER OF LIFE YEARS GEANED BY STARTING EARLIER SCREENING, STARTING AT 40 COMPARED WITH STARTING AT 50. CONVERGENT VALIDITY IS EXTREMELY IMPORTANT IN MODELING. NOW, THE QUESTION OF VALUES AND WHETHER OR NOT THAT'S THE TRADEOFF WE'RE MAKING HAS TO DO WITH WHAT ARE THE HARMS? I THINK EVERYONE AGREES THAT HAVING A FALSE POSITIVE DIAGNOSIS OF CANCER, THAT IS A CANCER THAT ISN'T REALLY A CANCER THAT'S REALLY BAD. THERE IS ACTUALLY QUITE A LOT MORE CONTROVERSY OR DISAGREEMENT OR DISCUSSION ABOUT HOW BAD IS A FALSE POSITIVE TEST? I THINK THAT THERE ARE MANY PEOPLE WHO SAID WHAT DO I CARE THAT I HAVE A POSITIVE TEST THAT TURNS OUT TO BE NEGATIVE? IT'S JUST A LITTLE NOTHING. I JUST, YOU KNOW, RUN DOWN TO THE RADIOLOGIST AND I HAVE ANOTHER MAMMOGRAM AND EVERYTHING IS FINE AND THEN I'M TOTALLY -- EVERYTHING IS OKAY. I THINK THAT THAT BEGS -- THAT DOES NOT TAKE INTO ACCOUNT THE EXPERIENCE OF INDIVIDUAL WOMEN FOR THE AMOUNT OF TIME THAT IT TAKES TO GET THIS DIAGNOSIS, AND I THINK THERE'S A TENDENCY TO DISMISS AS ENTIRELY TRIVIAL THE IDEA THAT A PERSON HAD A FALSE POSITIVE SCREENING TEST. THE EMPIRIC DATA ARE FEW AND IN MY OPINION, THEY'RE NOT VERY GOOD. THERE HAVE BEEN NO DATA AND WERE NO DATA AT THE TIME OF TASK FORCE DID THIS ASSESSMENT ABOUT WHETHER SCREENING TESTS AFFECTED WHETHER OR NOT YOU WERE INSURABLE. IT WON'T BE SO MUCH AN ISSUE NOW, SINCE THE PASSAGE OF AFFORDABLE CARE ACT INCLUDES PRE-EXISTING CONDITIONS, WHERE I DON'T KNOW IF A MAMMOGRAPHY IS -- THE FACTORS THAT GO INTO RATING WHEN THE INSURANCE COMPANIES ARE ALLOWED TO TAKE THAT INTO YT WHEN THEY MAKE DECISIONS. THEY NEVER BECOME CLINICALLY MANIFEST OR DIAGNOSIS OF CANCERS AT AN AGE WHERE YOU WOULD HAVE DIED OF ANOTHER CAUSE BEFORE DYING OF BREAST CANCER, IN FACT, THIS IS A MUCH BIGGER ISSUE AT OLDER AGES. I HAVE ALI SLIDE HERE BUT I'M NOT GOING TO GO OVER IT. WHEN THE TASK FORCE DID ITS WORK, IN FACT, THERE WASN'T VERY MUCH DATA ABOUT OVERDIAGNOSIS, AND THE BEST ESTIMATE THAT THE TASK FORCE COULD COME UP WITH BASED ON VERY BAD STUDIES WAS SOMEWHERE BETWEEN 1% AND 10 PER, WHICH IS A PRETTY WIDE RANGE AND I CONSIDER THIS INFORMATION ABOUT 1% TO 10% IS NOW -- HAS BEEN MADE OBSOLETE BY BETTER SCIENCE. THE ISSUE OF POLICY. WE ACTUALLY HAVE A LOT OF GOOD SCIENCE BE, A LOT OF GOOD SCIENTISTS THAT HAVE BEEN WORKING IN THIS FIELD FOR A VERY LONG TIME. WE HAVE STICK INFORMATION, WE HAVE MODELS THAT ARE CONVERGENT, WE HAVE PEOPLE THAT AGREE ABOUT WHAT THOSE TRADEOFFS MIGHT BE NUMERICALLY. WE MAY NOT HAVE AGREEMENT ABOUT HOW TO WEIGH THE CONSEQUENCES OF THOSE TRADEOFFS. NOW THIS GETS TRANSLATED INTO POLICY, AND POLICY IS A COURSE OF ACTION, GOVERNMENTS MAKE POLICY SH ORGANIZATION MAKES POLICY, AND WE ACTUALLY, IN MEDICINE AND HEALTH, POLICY OFTEN REFERS TO WHAT INSURANCE COMPANIES OR MEDICARE OR MEDICAID WILL COVER. PEOPLE THINK OF POLICY AS BEING RELATED TO LEGISLATION IN HEALTH, THE MOST IMPORTANT POLICY TO MANY PEOPLE ARE COVERAGE POLICIES. WHAT IS THIS THING THAT THAT GROUP SAID SHOULD OR SHOULDN'T BE DONE GOING TO TRANSLATE INTO IN TERMS OF WHAT I CAN OR CAN'T GET PAID FOR BY MY INSURANCE COMPANY. OR BY MEDICARE OR MEDICAID. PROBABLY MOST OF YOU KNOW THAT MEDICARE PAYS FOR MORE THAN 50% OF ALL THE MEDICAL SERVICES IN THE UNITED STATES. WHEN YOU ADD UP THE TOTAL FEDERAL CONTRIBUTION TO PAYMENT FOR MEDICAL CARE AND YOU INCLUDE NOT ONLY MEDICARE AND MEDICAID BUT THE V.A. AND THE FEDERAL BENEFITS INSURANCE CORPORATION AND THE INDIAN HEALTH SERVICE, IT'S WELL MORE THAN 50%. IT'S PROBABLY 65%. THE 1965 LEGISLATION THAT AUTHORIZED MEDICARE WAS SPECIFICALLY WORDED THAT THE PROGRAM WOULD PAY FOR THERAPEUTIC AND DIAGNOSTIC SERVICES. PREVENTIVE SERVICES WERE CONSIDERED TO BE SPECIFICALLY EXCLUDED FROM MEDICARE COVERAGE BASED ON THE 1965 ENABLING LEGISLATION, AND THIS MEANT THAT UNTIL 2008, IN ORDER TO COVER A PREVENTIVE SERVICE, MEDICARE HAD TO GET AN ACT OF CONGRESS. CONGRESS HAD TO PASS A BILL THAT SAID MAMMOGRAPHY IS COVERED BY MEDICARE, AND IN FACT, THEY DID PASS A BILL THAT MAMMOGRAPHY WAS COVERED BY MEDICARE IN 2001, AND IN 2008, THERE WERE 15 SERVICES FOR WHICH MEDICARE PROVIDED REIMBURSEMENT COVERAGE BASED ON 15 SEPARATE ACTS OF CONGRESS. THAT IS NOT THE WAY TO MAKE POLICY. SO IN 2008, WITH THE PASSAGE OF THE MEDICARE IMPROVEMENTS AND FOR PATIENTS AND PROVIDERS ACT OF 2008, THE SECOND OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES WAS PERMITTED, PERMITTED BUT NOT REQUIRED TO REQUIRE -- THIS IS SORT OF GOVERNMENTESE, RIGHT? TO PROVIDE MEDICARE COVERAGE FOR PREVENTIVE SERVICES THAT RECEIVED AN A OR B GRADE BY THE U.S. PREVENTIVE SERVICES TASK FORCE. I WAS VICE CHAIR IN 2008 WHEN THIS PASSED AND I THOUGHT IT WAS A TERRIBLE IDEA AT THE TIME. IT WAS MY PERSONAL OPINION THAT IT WAS GOING TO GREATLY PERVERT THE DISCUSSIONS ON BENEFIT BECAUSE THERE WAS GOING TO BE THIS CONCERN THAT IN MAKING A RECOMMENDATION BASED ON SCIENCE, THAT PEOPLE IN THE BACK OF THEIR HEADS WOULD SAY, OH, MY GOD, THIS IS GOING TO BE A COVERAGE DECISION, AND IN IN FACT, IN 2010, IT GOT KIND OF A LITTLE BIT WORSE, WHICH IS THE AFFORDABLE CARE ACT ACTUALLY SAID SPECIFICALLY IN LEGISLATION THAT -- ITEMS OR SERVICES THAT HAVE AN EFFECTIVE RATING OF A OR B IN THE CURRENT RECOMMENDATIONS OF THE U.S. PREVENTIVE SERVICES TASK FORCE MUST BE INCLUDED IN GROUP AND INDIVIDUAL INSURANCE COVERAGE PLANS WITHOUT A COPAYMENT OR CO-INSURANCE, AND THERE'S A SIMILAR SET OF IDENTICAL WORDING IN THE SECTION OF THE BILL THAT DEALS WITH MEDICARE. SO NOW IF U.S. PREVENTIVE SERVICES TASK FORCE RATES A GIVEN SERVICE AS HAVING AN A OR A B GRADE -- YES, GO BACK TO THAT GRID, THEN IT IS AUTOMATICALLY REQUIRED TO BE COVERED BY EVERY GROUP AND PRIVATE INSURANCE PLAN IN THE UNITED STATES AND BY MEDICARE. EXCEPT FOR THIS. THIS WAS PUT IN AT THE LAST MINUTE -- I'M GOING TO LEAVE YOU A SECOND TO READ THIS, BECAUSE IT IS DIABOLICAL. FOR THE PURPOSES OF THIS ACT, THE CURRENT RECOMMENDATION ARE NOT THE CURRENT RECOMMENDATION. THEY'RE THE MOST CURRENT RECOMMENDATIONS EXCEPT THE 2009 RECOMMENDATION. SO THIS WAS A VERY SPECIFIC REPUDIATION OF THE 2009 U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATION WHICH GAVE SCREENING MAMMOGRAPHY AT AGES 40, LESS THAN 50, A C GRADE RECOMMENDATION. THOSE SERVICES THAT MEANT ABSENCE -- MAMMOGRAPHY FOR WOMEN LESS THAN 50 WOULD NOT BE AUTOMATICALLY COVERED BASED ON THE AFFORDABLE CARE ACT PROVISION. NOW I THINK -- AND THIS GETS TO THE -- WE REALLY HAVE GOOD SCIENCE. I THINK WE HAVE HEERYLY BAD POLICY. THE REASON WHY I THINK IT'S BAD POLICY IS FIRST OF ALL, I DON'T THINK THAT A LINKAGE OF A SPECIFIC RECOMMENDATION OF A SPECIFIC GROUP THAT CAN CHANGE, WHERE THE GROUP CAN CHANGE, ITS PROCEDURES CAN CHANGE, TO AUTOMATIC KORCHL FOR AL -- AUTOMATIC COVERAGE FOR ALL KINDS OF INSURANCE IS GOOD POLICY. I PERSONALLY THINK THAT GROUPS CONVENE TO DETERMINE AND ASSESS THE SCIENTIFIC EVIDENCE OF BENEFITS AND HARM ARE NOT COMPRISED OF THE SAME PEOPLE WHO ARE BEST ABLE TO THINK ABOUT WHAT ARE THE IMPLICATIONS OF THIS SET OF SCIENTIFIC DATA ON BENEFITS AND HARM FOR WHETHER OR NOT SOMETHING SHOULD BE COVERED. I THINK IT'S NOT GOOD POLICY TO WRITE INTO LEGISLATION THE MOST CURRENT -- THE DATE OTHER THAN THE DATE THAT'S MOST CURRENT. BOY, I HAVE TO TELL YOU THAT I WAS UTTERLY UNPREPARED TO BE THE SPOKESPERSON FOR A TOPIC THIS CONTROVERSIAL. I KIND OF KNEW THAT IT WASN'T GOING TO GO DOWN WELL. I WAS PREPARED TO TRY TO EXPLAIN THE REASONING AND I REALLY KNEW THE DATA, I REALLY KNEW THE MODELS, I WENT THROUGH ALL SORTS OF PRESS TRAINING, BUT BOY, I KNEW WE WERE IN BIG TROUBLE WHEN I GOT A CALL AT 9:00 AT NIGHT AT MY HOME FROM SOMEONE HYSTERICAL FROM ABC NEWS WANTING ME TO GIVE AN INTERVIEW THE NEXT MORNING. I KNEW WE WERE IN REALLY BIG TROUBLE WHEN I GOT A CALL FROM THE LARRY KING SHOW WANTING ME TO BE ON THE LARRY KING SHOW. BY THE TIME THESE RECOMMENDATIONS HAD BEEN ISSUED AND WERE NO MORE THAN 48 HOURS OLD, I WAS BASICALLY SPENDING ALL OF MY TIME DOING NOTHING BUT TRYING TO MANAGE THE MEDIA FIRESTORM THAT CAME BASED ON THESE RECOMMENDATIONS. NOW I PUT IN A LINK, THIS IS GOING TO BE POSTED -- PUT IN A LINK TO THE AMERICAN COLLEGE OF RADIOLOGY STATEMENT, AND THIS ONE WAS -- THIS IS AN EXCERPT FROM THE AMERICAN COLLEGE OF RADIOLOGY STATEMENT ABOUT THE U.S. PREVENTIVE SERVICES TASK FORCE. I BOLDED THE RED, THEY DIDN'T PUT IT IN RED. IT ACTUALLY SAID THAT IN A WAY THAT I THINK IS ACTUALLY QUITE UNFAIR THAT WE HAD DISMISSED THOUSANDS OF SCIENTIFIC STUDIES AND DATA ANALYSIS THAT WE HAD IGNORED THE PHYSICAL AND PSYCHOLOGICAL HARM OF ADVANCED CANCERS, THAT WE HAD PRIORITIZED DOLLARS OVER LIVES SAVED. I THOUGHT THAT THIS WAS ACTUALLY PRETTY INSULTING. I FOUND IT PERSONALLY INSULTING THAT THE RECOMMENDATIONS HAD BEEN MADE WITHOUT INVOLVING ANYONE WITH EXPERTISE IN BREAST CANCER DETECTION AND DIAGNOSIS. AND IN FACT, YOU KNOW, I HAD BEEN THE VICE CHAIR OF THE NATIONAL CANCER POLICY BOARD. I HAD BEEN ON A COMMITTEE THAT ISSUED A REPORT ABOUT NEW TECHNOLOGIES FOR MAMMOGRAPHY. WE HAD SOMEONE WHO WAS THE DIRECTOR OF A CANCER CENTER, PREVENTION CENTER. WE HAD PEOPLE WHO HAD PUBLISHED EXTENSIVELY ON THE AREA OF MAMMOGRAPHY SCREENING, BUT THIS ITHISIS WHAT MADE IT INTO THE PRESS, AND THAT'S POLICY. HERE'S ANOTHER ONE. AGAIN, FROM THE RADIOLOGIST, THAT THE GUIDELINES WOULD WIPE OUT DECADES OF PROGRESS. THIS IS POLITICS. AND IT'S THE POLITICS OF SELF-INTEREST. AND I BECAME EXTREMELY CYNICAL ABOUT THE POLITICS OF SELF INTEREST FOR THIS PARTICULAR TOPIC. I GUESS I SHOULD KIND OF PICK ON HHS SINCE I'M NEAR THE END OF MY CAREER AND I'M NEVER GOING TO WRITE ANOTHER GRANT, WHICH IS -- I THOUGHT IT WAS A LITTLE BIT OF AN UNDERMINING OF THE GROUP THAT HAD BEEN WORKING UNDER THE GENERAL OVERSIGHT OF HEALTH AND HUMAN SERVICES FOR THE SECRETARY TO BASICALLY SAY FORGET WHAT THE TASK FORCE SAID, DO WHATEVER YOU WANT. IT'S KEEP ON DOING WHAT YOU'RE DOING, AND THIS WAS KIND OF A LITTLE BIT CHICKEN IN A WAY. I THOUGHT IT WAS ACTUALLY WORSE WHEN THE HEAD OF NCI AT THAT TIME CANCELED THE PRESS RELEASE THAT WAS COMING FROM THE NCI, EXPRESSING SUPPORT FOR THE MODELING WORK DONE IN SUPPORT OF THE RECOMMENDATIONS. IT WAS LIKE, OH, WE DON'T WANT TO GET INVOLVED IN THIS. SO IT WAS KIND OF A PAINFUL EXPERIENCE AS A SCIENCE PERSON PUT UNFORTUNATELY IN A POLICY POSITION IN A MASSIVELY POLITICALLY CHARGED ENVIRONMENT. I INCLUDED THESE TWO LINKS BECAUSE ACTUALLY THESE ARE YOUTUBE VIDEOS OF HILLARY CLINTON TESTIFYING IN 1997 ABOUT EXACTLY THE SAME ISSUE. IN A PRIOR SORT OF HULLABALOO OF MAMMOGRAPHY SCREENING BEFORE AGE 50. I SHOULD HAVE SEEN THIS BEFORE I AGREED TO BE THE SPOKESPERSON. NEXT TIME I'M GOING TO DO MY HOMEWORK BEFORE I'M THE SPOKESPERSON FOR ANYTHING. MOW, IN THE AFTERMATH, I THINK THE SCIENCE HAS ACTUALLY SUPPORTED SOME OF -- PROVIDES MORE INFORMATION THAT MAKES PEOPLE SAY, GEE, MAYBE THEY GOT IT KIND OF A LITTLE BIT RIGHT. ACTUALLY THERE'S BEEN QUITE A LOT OF NEW DATA TA THAT SUGGESTS THAT THE PROBLEM IS OVERDIAGNOSED QUITE A BIT GREATER THAN THE 1 TO 10% ESTIMATED AT THAT TIME AND THAT THE DATA ARE ACTUALLY BEGINNING -- A NUMBER OF DATA FROM A NUMBER OF SOURCES ACTUALLY HAVE COME TO QUESTION THE MAGNITUDE OF THE OVERALL IMPACT OF MAMMOGRAPHY SCREENING PROGRAMS ON MORTALITY FROM BREAST CANCER, WHICH IS DECLINING AND HAS DECLINED IN THE UNITED STATES, THANK GOODNESS, OVER THE LAST DECADE AND ALSO IN A VARIETY OF OTHER WESTERN COUNTRIES WHERE IT HAD BEEN RISING PRETTY MUCH INEX-OR BLI UP TO ABOUT A DECADE AGO. THIS IS JUST ONE EXAMPLE AND PARTLY I INCLUDED THESE SLIDES BECAUSE THIS TALK IS GOING TO GO ON THE WEBSITE AND I THINK THERE'S A LOT OF INFORMATION HERE RECENTLY, THIS SHOWS AN ESTIMATE FROM THE NUMBER OF BREAST CANCERS THAT WERE DIAGNOSED WITH AND WITHOUT SCREENING, SUGGESTING THAT ABOUT 30% OVERDIAGNOSIS. THIS IS ANOTHER VERY INTERESTING SLIDE THAT SHOWS THAT FROM A STUDY DONE BY WELCH AND COLLEAGUES AT DARTMOUTH, SHOWING THAT, IN FACT, THERE HASN'T BEEN MUCH OF A CHANGE IN INVASIVE BREAST CANCER AT THE SAME TIME THAT EARLY BREAST CON SER CASES, THE NUMBER HAS INCREASED GREATLY, AND ONE OF THE, OSKT, REASONS WHY WE THINK THAT BREAST CANCER -- MAMMOGRAPHY SCREENING DECREASES BREAST CANCER MORTALITY IS BY PREVENTING THE DEVELOPMENT OF LATER STAGE CANCERS. I DON'T THINK THIS PROVES THAT MAMMOGRAPHY 7R. ISN'T PREVENTING LATE STAGE CANCERS BUT THERE ISN'T QUITE THE ONE TO ONE CORRELATION BETWEEN DECLINING, INCREASING EARLY CANCER DIAGNOSIS THAT ONE WOULD EXPECT. NOW, MY OWN CONCLUSIONS AND OBSERVATIONS ARE THAT THERE'S A LOT OF GOOD SCIENCE ABOUT MAMMOGRAPHY, AND THAT GOOD SCIENCE HAS THE POTENTIAL TO INFORM GOOD POLICY. THE GOOD SCIENTIST REALLY, I WOULD SAY DIFFICULT, I WOULD SAY IT'S ALMOST IMPOSSIBLE TO COMMUNICATE IN A POLITICIZED ENVIRONMENT. I THINK THAT THE COVERAGE POLICY, CURRENT COVERAGE POLICY OF THE AFFORDABLE CARE ACT 2010-2008 POLICY, MAKES IT EXTREMELY DIFFICULT TO FOLLOW THE SCIENCE WHEN, IN FACT, OR EVEN SAY WHAT THE SCIENCE IS WHEN IT'S INEXTRICABLY LINKED TO A COVERAGE POLICY. I LEARNED THAT, BOY, ARE SCIENTISTS NOT GOOD AT POLITICS AND I COUNT MYSELF AMONG THEM. I WAS UTTERLY IMPAIRED TO WORK IN THE KIND OF POLITICIZED ARENA I WAS ASKED TO WORK IN. I KNOW FOR SURE THAT POLITICIANS ARE NOT GOOD AT SCIENCE. I HEARD SOME THINGS FROM VARIOUS STAFF PEOPLE AND POLITICAL PEOPLE THAT WERE KIND OF SUGGESTED THAT THEY DIDN'T KNOW HOW TO ADD AND SUBTRACT. NOW I ALSO LEARNED, AND THIS IS PROBABLY ONE OF MY BIGGEST LEARNING SETS, WE DON'T PAY ATTENTION TO IMPORTANT WORDS. THIS IS ACTUALLY DIRECTLY FROM THE ANNALS, AND YOU CAN SEE THAT THE STATEMENT, THE DECISION TO START REGULAR, BIANNUAL MAMMOGRAM BEFORE THE AGE OF 50 WAS INDIVIDUAL WAS PREFACED BY A SENTENCE. THE TASK FORCE RECOMMENDS -- THE RED ARROWS, BY THE WAY, WEREN'T IN THE ANNALS -- AGAINST ROUTINE. WE THOUGHT WE WERE TALKING ABOUT A ROUTINE, AND WHAT PEOPLE HEARD WAS -- ALL THEY GOT TO WAS AGAINST. ALL THEY HEARD WAS THAT SOMEBODY SAID THAT THEY WERE AGAINST MAMMOGRAPHY, AND THEY HEARD NOTHING ELSE. THERE'S BEEN A GREAT DEAL OF EFFORT BY THE TASK FORCE, AND I THINK BY OTHER GROUPS ATTEMPTING TO MAKE EVIDENCE-BASED RECOMMENDS TO FRAME THOSE RECOMMENDATIONS AND THE WORDING OF THOSE RECOMMENDATIONS MORE CAREFULLY. HERE'S SOME THAINGS PUZZLE ME. WHY DO WE GET SO UPSET ABOUT THIS TOPIC? THE TASK FORCE ISSUED A BUNCH OF RECOMMENDATIONS ABOUT SCREENING -- COLORECTAL CANCER SCREENING THAT COULD HAVE BEEN EQUALLY CONTROVERSIAL BASED OP THE SCIENCE. NOBODY CARED. IT'S LIKE, YAWN. WHY IS IT SO POLITICAL? IT'S VERY POLITICAL. PROBABLY FOR THE REASONS WHY IT'S POLARIZED. I'M ACTUALLY SURPRISED THAT WOMEN ARE SO WILLING TO BE OVERDIAGNOSED. AS WE KNOW MORE ABOUT OVERDIAGNOSIS, WHY WOULD I WANT TO HAVE A DIAGNOSIS OF BREAST CANCER, 55, IF IT WOULDN'T HAVE ANY AFFECT ON ME. I DON'T UNDERSTAND WHY THERE ARE SOME FALSE POSITIVES AND THE U.S. TOLERATES THIS FALSE POSITIVE RATE, THOSE THAT ORGANIZE SCREENING PROGRAMS SUCH AS THE U.K. HAVE A MUCH LOWER RATE OF FALSE POSITIVES. I'M ONLY TWO MINUTES OVER MY TIME SO WE HAVE TIME FOR QUESTIONS. >> DR. PETITTI, THANK YOU VERY, VERY MUCH. THIS IS A ROOKIE QUESTION BUT I NOTICED IN HEALTH TODAY "MAMMOGRAM RECALL HIGHER AT HOSPITALS THAN IN PRIVATE PRACTICES. STUDY, HE REPEAT QWEST TESTS, CAUSE ANXIETY AND ADDITIONAL COST FOR PATIENT. I WONDERED IF YOU COULD COMMENT ON THAT. >> WELL, I THINK THAT THE GOOD THING ABOUT DRAWING ATTENTION TO THE ISSUE OF FALSE POSITIVES IS THAT THERE ARE MANY MORE PEOPLE WHO ARE ASKING REALLY GOOD QUESTIONS AND BEEFING UP THE SCIENCE OF THIS TOPIC. THEY'RE GOING ABOUT TRYING TO FIGURE OUT WHERE ARE THEIR HIGH RATES OF FALSE POSITIVES, HOW DO WOMEN RESPOND TO THEM, ARE THEY A YAWN OR ARE THEY ACTUALLY SOMETHING THAT CAUSES DISTRESS IN SOME WOMEN. SO IT'S ALL TO THE GOOD AND PEOPLE ARE FOCUSING ON THESE TOPICS. >> THANKS. THANKS A LOT. >> I'M FROM EMORY UNIVERSITY. THIS WAS REALLY AN EYE OPENER, THIS WAS GREAT, BUT I'M A BASIC SCIENTIST AND COMING FROM LABORATORY SCIENTIST, COMING FROM A LABORATORY, IF I'VE SEEN PRECANCEROUS LESIONS, IS ACTUALLY A PRECURSOR FOR FULL BLOWN FRANK CARCINOMA, THEN I PERSONALLY WOULD DEFER DIAGNOSIS EVEN IF IT IS LATER, SO I CAN SEE BOTH SIDES HERE. I MEAN, I CAN EMPATHIZE WITH THOSE WHO WOULD GO FOR -- WHO WOULD LIKE TO HAVE THE DIAGNOSIS, SO I DON'T KNOW THAT I'M -- THE FACT IS, NOT STATISTICS WHEN IT COMES TO -- AND FRUSTRATE, I DON'T WANT TO DEPEND ON THE STATISTICS FOR MY MOM HAVING A NODULE, WHAT IS THE PERCENTAGE OF IT KILLING HER, EVEN IF THERE IS 2%, SHE WOULD RATHER GET RID OF IT. >> I THINK IT ILLUSTRATES THE DILEMMA. I MEAN, IF YOU COULD -- ONCE SOMEONE HAS A NODULE, THEY'RE REALLY NOT IN THE MAMMOGRAPHY SCREENING ARENA, THEY'RE IN THE DIAGNOSIS ARENA. I THINK ONCE YOU DO A MAMMOGRAM AND YOU FIND OUT THERE IS SOMETHING THAT IS CANCER THERE, YOU'RE PRETTY MUCH GOING TO GET IT TREATED. I WOULDN'T WANT TO TELL PEOPLE THEY SHOULDN'T GET IT TREATED. IT'S HARD TO EXPLAIN THE CONCEPT OF THE LATENT PERIOD. THE PERIOD WHEN THE CANCER IS THERE AND DETECTABLE BY SOME MEANS, BUT ISN'T ACTUALLY DOING ANY HARM, AND WHY YOU WOULDN'T WANT TO FIND IT THE MINUTE THERE'S A SINGLE CANCEROUS CELL. AND THAT MIGHT BECOME POSSIBLE IN OUR LIFETIME. SO IF YOU COULD FIND -- YOU HAD A TEST THAT COULD FIND THE FIRST CANCER CELL IN THE BREAST AT AGE 20, WOULD YOU WANT TO DO THAT? >> WELL, THE OPPOSITE SIDE WOULD SAY IT ISN'T CAUSING ANY HARM YET, DO I WANT TO REALLY TAKE A CHANCE OF IT BEING A METASTASIZED AND THEN I'M OUT OF CONTROL? I CAN UNDERSTAND BOTH PER SPEC TIFTS. >> I CAN TOO. THAT'S WHY I FRAME THIS AS AN ISSUE OF AGE 20 IS SINGLE CELL. IT ACTUALLY WOULD DEPEND ON WHAT YOU HAD TO DO IN ORDER TO BE 100% CERTAIN THAT IT WOULDN'T PROGRESS. >> HI. THANKS FOR YOUR TALK. I HAVE A COMMENT AND A QUESTION. AT THE VERY END, YOU SAID YOU WERE SURPRISED THE USPSTF RECOMMENDATION ABOUT CT COLONGRAPHY ELICITED A YAWN BUT THE MAMMOGRAPHY RECOMMENDATION, LISTED IT, WHAT SOUNDED LIKE PANIC. MY COMMENT IS THAT IN ONE CASE FOR CT COLONGRAPHY, THE TASK FORCE WAS DENYING A NEW TEST, WHEREAS FOR THE MAMMOGRAPHY, THE USPSTF WAS IN A SENSE IGNORE IGNORING -- I PUT THAT LIFE SAVING IN QUOTES BASED ON WHAT YOU SAID. THAT'S MY COMMENT. MY QUESTION IS REGARDING THE TASK FORCE'S SURPRISE ABOUT THE PUBLIC UPROAR ABOUT YOUR RECOMMENDATION, AND YOU SAID IN YOUR PRESENTATION THAT THE TASK FORCE'S DECISIONS WOULD HAVE POLICY EFFECTS WHETHER THE TASK FORCE LIKED IT OR NOT, BECAUSE OF THESE LAWS. NOW I WOUL WONDER WHETHER YOU'D CONSIDER HAVING SOME SORT OF THOUGHT ABOUT WHAT THE POTENTIAL PUBLIC REACTIONS WOULD BE TO TASK FORCE RECOMMENDATIONS THAT WERE POTENTIALLY OF A HIGH MAGNITUDE AND WHETHER -- NOT SO MUCH THAT THE PRESENTATION OF RESULTS WERE TESTED IN A FOCUS GROUP, PER SE, BUT WITH SOME THOUGHT POTENTIALLY GIVEN TO HOW TO MANAGE THE RELEASE OF THE INFORMATION IN THE OPTIMAL WAY POSSIBLE. >> WELL, CERTAINLY NOT ENOUGH. I THINK THAT THE TASK FORCE RECOMMENDATION ABOUT MAMMOGRAPHY WAS ISSUED IN THAT WINDOW BETWEEN 2008 AND 2010, WHERE THE 2008 LEGISLATION SAID THAT THE TASK FORCE RECOMMENDATION WERE INFORMATION TO BE CONSIDERED BY THE SECRETARY IN MAKING ITS COVERAGE DECISIONS BUT THERE WAS NO AUTOMATIC LINK BETWEEN A AND B SERVICES AND PROVISION OF COVERAGE. SO WE DIDN'T THINK ABOUT -- WE DIDN'T THINK THAT THESE RECOMMENDATIONS WOULD BE USED TO DENY COVERAGE. AND REMEMBER, THE SECRETARY COULD, FOR MEDICARE, MANDATE COVERAGE OF ANYTHING. THE SECRETARY COULD DECIDE TO COVER MAMMOGRAPHY THAT WAS A C RECOMMENDATION TO SAY THAT MEDICARE HAD TO COVER A C RECOMMENDATION MAMMOGRAPHY WITHOUT REFERENCE TO ANYTHING. THE DIFFERENCE IN 2010 -- REMEMBER THE LEGISLATION WAS PASSED AFTER THESE RECOMMENDATIONS WERE ISSUED. THE LEGISLATION WAS PASSED IN 2010, THESE RECOMMENDATIONS WERE ISSUED IN 2009. WHAT IT MEANT IS THAT FROM THAT DAY FORD, A C RECOMMENDATION MEANT THAT IT WAS NOT AUTOMATICALLY COVERED. SO THE TASK FORCE DIDN'T EVEN CONSIDER THAT BECAUSE IT WASN'T PART OF THE LEGISLATION. SO DIFFERENT SITUATION. NOW, I THINK -- I'M NOT ON THE TASK FORCE ANYMORE -- THAT IT'S GOING TO BE EXTREMELY DIFFICULT FOR THEM TO DO THEIR WORK, GIVEN THE AUTOMATIC KORCHL LINK. >> I WAS WONDERING IF YOU MIGHT HAVE A PERSPECTIVE ON THE RECENT RECOMMENDATIONS FOR CERVICAL CANCER SCREENING, BECAUSE SUPERFICIALLY, THEY ACTUALLY HAVE SOME RESEMBLANCE TO THE 2009 RECOMMENDATION, IN THE SENSE THAT THE AGE OF SCREENING WAS INCREASED, THE INTERVALS RECOMMENDED FOR SCREENING WAS BE INCREASED, AND MAXIMUM AGE WAS RECOMMENDED, AND YET THERE WASN'T THE SAME KIND OF RESPONSE THAT YOU HAD IN 2009. >> THAT'S AN ACTUALLY BETTER ANOLG. ANALOGY. FROM ONE POINT OF VIEW, THE CERVICAL CANCER RECOMMENDATIONS ARE AS, QUOTE, RADICAL AS THE MAMMOGRAPHY SCREENING RECOMMENDATIONS. NOW THERE ARE A COUPLE OF DIFFERENCES. ONE OF THEM IS THAT THERE WERE OTHER ORGANIZATIONS THAT WERE BROUGHT ON BOARD WITH THESE RECOMMENDATIONS, AND ACTUALLY PREISSUED THEM. IN REALITY AND ANTICIPATION OF THE TASK FORCE ISSUING THEM AND IN ORDER TO, IN MANY WAYS, PREEMPT THE TASK FORCE SAYING WHAT THE EVIDENCE SHOWED, WHICH IS YOU REALLY DON'T AND ACTUALLY REALLY SHOULDN'T SCREEN BEFORE AGE 21. THE INCREMENTAL VALUE OF SCREENING EVERY YEAR VERSUS EVERY THREE YEARS IS ALMOST ZERO, AND SCREENING ANYONE OVER 65 WHO HAS BEEN PREVIOUSLY SCREENED IS A TOTAL WAIST OF TIME. SO I THINK -- WASTE OF TIME. SO I THINK THERE WAS A POLITICAL DIFFERENCE IN THE POLITICS, THE TASK FORCE COULD HAVE ATTEMPTED TO BRING IN OTHER GROUPS AND I THINK THE QUESTION FOR SCREENING RECOMMENDATIONS A THAT ARE NOW SO IMPORTANT AND COVERS SOME DIFFERENT PEOPLE AND INVOLVES SO MANY DIFFERENT GROUPS, SHOULDN'T THERE BE SOME KIND OF MULTISIDE CAPS FOR IT TO DEAL ONLY WITH THE ISSUE OF MAMMOGRAPHY SCREENING AND ONLY WITH THE ISSUE OF COLORECTAL CANCER SCREENING, OR SHOULD THERE BE A CANCER SCREENING TASK FORCE FOR PEOPLE WHO ONLY DEAL WITH CANCER SCREENING RATHER THAN 72 OTHER TOPICS BESIDES CANCER SCREENING. >> SO I'M INTERESTED IN WHAT YOU THOUGHT -- SORR SORT OF ABOUT THE CONTEXT IN WHICH YOUR RECOMMENDATIONS CAME OUT BECAUSE MY RECOLLECTION WAS IT WAS CONGRESS WAS ACTUALLY DEBATING THE AFFORDABLE CARE ACT AND RIGHT AROUND THAT TIME PERIOD, AND I WONDER IF THAT REALLY HELPED TO MAGNIFY THE AMOUNT OF -- THAT HAS TO HAPPEN? >> I THINK THAT'S AN EXCELLENT POINT, PART OF AN EARLIER VERSION OF THE TALK. THE RECOMMENDATIONS WERE ISSUED AT A TIME WHEN THE PASSAGE OF THE AFFORDABLE CARE ACT WAS IN THE THROES OF DEBATE IN CONGRESS. IT WAS VERY CLEAR THAT THE PEOPLE AGAINST THE AFFORDABLE CARE ACT WERE USING THE TASK FORCE TO SHOW HOW BIG GOVERNMENT WAS GOING TO INTERFERE WITH THEIR ABILITY TO GET WHAT THEY WANTED AND NEEDED. THE PROPONENTS OF THE AFFORDABLE CARE ACT WERE EQUALLY LIKE TOTALLY UPSET ABOUT THEM BEING ISSUED BECAUSE THEY KNEW THAT THEY WERE GOING TO BE USED IN IT WAY. SO IT WAS LIKE BEING THROWN INTO THE FIRE. IT TRULY WAS. HAD THE RECOMMENDATIONS BEEN ISSUED EIGHT MONTHS BEFORE, IT PROBABLY WOULD HAVE BEEN MORE OF A YAWN. IT STILL WOULD HAVE BEEN CONTROVERSIAL BUT IT WOULDN'T HAVE BEEN -- I WON'T HAVE HAD PEOPLE DRIVING UP TO MY HOUSE IN THE NEWS VANS WHILE I WAS IN MY PAJAMAS TRYING TO INTERVIEW ME, AND THAT LITERALLY HAPPENED. I HAD PEOPLE WHO TRIED TO GET ME FIRED FROM MY JOB AT ASU. IT WAS REALLY QUITE A NEGATIVE EXPERIENCE BECAUSE I WAS UNPREPARED FOR IT. I THINK MOST SCIENTISTS ARE UNPREPARED. >> THANK YOU FOR THIS TALK. SINCE YOU MENTIONED RISK, I WONDERED IF YOU HAD ANY THOUGHTS ABOUT EFFECTIVE WAYS TO CONVEY RISK TO THE PUBLIC AND ALSO IF YOU HAD ANY THOUGHTS ABOUT ANG LENANGELINA JOLIE AND THE EFFECTS THAT MAY OR MAY NOT HAVE HAD. >> I DON'T THINK I KNOW EXACTLY HOW TO CONVEY RISK, THE TABLE THAT I SHOWED FROM THE ANNALS, THAT IS NOT A GOOD WAY TO PRESENT DATA TO THE PUBLIC. I THINK IT'S QUITE INTERESTING THAT THE MESSAGE ABOUT THE RCA1 TESTING AND THE DECISIONS TO HAVE A -- MASTECTOMY WAS SO WELL RECEIVED WHEN IT WAS DELIVERED WHO WAS A PERSON OF THE PROFILE OF ANG LENA JOLIE. IF I WERE CRAFTING A PUBLIC RELATIONS CAMPAIGN ABOUT ANYTHING RELATED TO MAMMOGRAPHY, I'D WANT TO HAVE A SPOKESPERSON WHO WAS NOT A SCIENTIST, SOMEONE WHO COULD CREATE A HUMAN FACE TO THE ISSUE, MAYBE OF OVERDIAGNOSIS OR FALSE POSITIVES. I DON'T THINK WE DID A GOOD JOB OF COMMUNICATING AND I THINK THESE COMPLICATED HIGHLY NUMERIC ISSUES ARE DIFFICULT TO COMMUNICATE. WE HAVE TIME FOR ONE MORE SHORT QUESTION. >> FIRST THANKS FOR THE VERY EYE OPENING SESSION. DON'T YOU THINK YOU WERE A LITTLE BIT OUTMANEUVERED BY TWO POPULATIONS THAT YOU ACTUALLY -- YOU GAVE THEM THE CREDIT OF THE DOUBT OF ACR IS BASICALLY A VESTED PHYSICIAN THAT HAD LET'S SAY A COMMERCIAL INTEREST HERE, AND THAT LINKS ON TO POLICY. AND ALSO WHAT'S BEEN DESCRIBED AS THE BREAST CANCER INDUSTRY THAT'S BEEN CRITICIZED IN PINK RIBBON, INC. BOTH OF THEM, I ASSUME, FUELING THE BROUHAHA AND TRYING TO GET THESE GUEST RELEASES EVEN BEFORE YOU GET THE RECOMMENDATION. SO MY QUESTION AT THE BASE OF THIS IS, HAS THERE BEEN RE-THINKING OF HOW TO BRING THE POLICY AND HOW TO BRING THESE KIND OF FACES TO THE CROWD IN ORDER TO BRING -- TO COUNTERBALANCE THESE HUGE VESTED INTERESTS, BOTH AT CAPITOL HILL AND THE MEDIA. >> THERE WAS A LOT OF LEARNING. AS THE TASK FORCE LEARNED IN THAT TWOO-WEEK PERIOD WHEN WE WERE ALL GOING CRAZY AND LOSING SLEEP. WE REALLY DIDN'T FIGURE OUT WHO OUR FRIENDS WERE AND INVOLVE THEM IN BEING OUR FRIENDS OR AT LEAST NOT BEING OUR ENEMIES. I THINK I WAS SURPRISED AT THE LEVEL OF ORGANIZATION AND THE VEHEMENCE. THEY WERE TOTALLY ORGANIZED, THEY HAD SPOKESPEOPLE ALL OVER THE COUNTRY, THEY ISSUED THEIR PRESS RELEETS EVE RELEASE -- THEY HAD A PRESS RELEASE PREPARED BEFORE THE RECOMMENDATIONS FOR UNEMBARGOD, SO THEY HAD AN ADVANCED COPY. SO IN RETROSPECT WE SHOULD HAVE KNOWN WHO OUR FRIENDS WERE, WE SHOULD HAVE CALLED ON OUR FRIEND, WE SHOULD HAVE ANTICIPATED THERE WOULD BE -- I WOULD HAVE HAD TO HAVE BLOCKED MY CALENDAR. I HAD NO IDEA IT WAS GOING TO BE LIKE THAT. I SHOULD HAVE BLOCKED MY CALENDAR FOR FOUR WEEKS, I ENDED UP ESSENTIALLY DOING NOTHING BUT MAMMOGRAPHY PREP FOR FOUR WEEKS, BUT I HAVE TEACHING AND ALL THIS OTHER STUFF SO I WOULD JUST THINK A LOT DIFFERENTLY. >> OKAY. >> THANK YOU. [APPLAUSE] >> THE LAST QUESTION -- >> PEOPLE CAN LEAVE. >> OH, YES. YOU JUST MENTIONED IN YOUR LECTURE THAT THE -- PROGRESS SCREENING -- 1 14 AND BEFORE. I'M A BREAST SURGEON FROM VIETNAM, AND WE FIND MUCH MORE YOUNG AGE BREAST CANCER IN MY COUNTRY, SO DO YOU HAVE ANY EXPLANATION? >> I THINK ANY -- I THINK IT WOULD BE UNFAIR TO SAY THAT THE AGE TO START SCREENING IS RECOMMENDED TO BE 50. IT IS THAT THE DECISION ABOUT WHEN TO BE SCREENED SHOULD BE ONE THAT IS DONE CAREFULLY THINKING ABOUT WHAT THE GAINS ARE AND WHAT THE TRADEOFFS ARE. IT MIGHT BE 40 FOR SOME WOMEN WHO ACTUALLY ARE VERY WORRIED ABOUT BREAST CANCER, IT MIGHT BE 42, IT MIGHT BE 47, IT MIGHT BE 50. THE POLICY ISSUE ABOUT SCREENING -- RECOMMENDING WOMEN BE SCREENED AT 40, 45 OR 50, HAS TO TAKE INTO ACCOUNT THE BACKGROUND INCIDENCE OF BREAST CANCER, SO ONE OF THE QUESTIONS THAT HAS COME UP IN OTHER FORMS IS WHETHER OR NOT AFRICAN-AMERICAN WOMEN SHOULD BE SCREENED EARLIER, AND IT TURNS OUT THAT NNCH HAVE -- BETWEEN 35 AND 45 FOR REASONS WE DON'T UNDERSTAND SO ARE THEY A SPECIAL GROUP? AND IT MAY BE THAT IN YOUR COUNTRY, THERE ARE SPECIAL EPIDEMIOLOGICAL CIRCUMSTANCES THAT WOULD WARRANT A DIFFERENT RECOMMENDATION ABOUT WHEN TO START THINKING ABOUT ROUTINE SCREENS. [APPLAUSE] >> DR. PETITTI WILL BE AVAILABLE FOR QUESTIONS IF YOU HAVE ADDITIONAL THINGS.