Welcome to the Clinical Center Grand Rounds, a weekly series of educational lectures for physicians and health care professionals broadcast from the Clinical Center at the National Institutes of Health in Bethesda, MD. The NIH Clinical Center is the world's largest hospital totally dedicated to investigational research and leads the global effort in training today's investigators and discovering tomorrow's cures. Learn more by visiting us online at http://clinicalcenter.nih.gov I'M DAVE WENDLER, DEPARTMENT OF BIOETHICS HERE AT THE CLINICAL CENTER. JUST A REMEMBERER FOR PEOPLE WHO PLAN AHEAD, THE LAST ETHICS GROUND ROUNDS IS THE FIRST OF APRIL. APRIL 1. HERE AT NOON IN THE LIPSETT AUDITORIUM. WE LOOK FORWARD TO SEEING PEOPLE FOR THAT. YOU REALIZE THE WAY THIS GOES WHAT, WE DO OUR DEPARTMENT, DEPARTMENT OF BIOETHICS TAKES OVER GRAND ROUNDS 4-5i] TIMES A YEAR. WE PRESENT WHAT WE THINK IS AN IMPORTANT INTERESTING CASE OR ISSUE THAT RAISES WHAT WE THINK ARE IMPORTANT ETHICAL ISSUES TO DISCUSS. THEN WE INVITE IN AN OUTSIDE EXPERT TO GIVE THEIR VIEWS ON THE TOPIC AND LEAD US IN A DISCUSSION OF THAT TOPIC. A LOT OF THESE CASES COME FROM CONSULTS WE'VE HAD. WE HAVE A CONSULTATION SERVICE FOR ANYBODY WHO IN THE CLINICAL CENTER WANTS TO DISCUSS AN ETHICAL ISSUE. FOR PEOPLE WHO HAVE BEEN AROUND FOR THE LAST COUPLE YEARS WE HAVE BEEN DOING A LOT OF CUTTING EDGE, DUAL USE RESEARCH, WE'VE DONE WHETHER OR NOT INVESTIGATORS HAVE OBLIGATIONS TO PROVIDE ANCILLARY CARE TO RESEARCH SUBJECTS WITH RESPECT TO CLINICAL CARE. WE DID A CASE ON WHETHER OR NOT FAMILY MEMBERS SHOULD BE PERMANENT MITTED TO ATTEND -- PERMITTED TO ATTEND CLINICAL ROUNDS WITH THEIR CHILDREN, AND DID A CASE -- ONE OF MY FAVORITE ONES, ON WHETHER OR NOT IT'S ACCEPTABLE TO KEEP SOMEONE BRAIN DEAD IN AND ICU, AND PROVIDE THEM WITH HERBAL MEDICATIONS FOR A COUPLE OF YEARS. SO LOTS OF CUTTING EDGE ISSUES. TODAY WE'LL CHANGE THAT UP AND PRESENT WHAT YOU MIGHT REGARD AS IN FACTUALLY NOT. FATCALLY NOT CUTTING EDGE ISSUE. THAT'S THE THEY WILL ISSUE IT RAISES, AN ISSUE AROUND FOR A LONG TIME. YOU MIGHT NOT THINK IT'S CUTTING EDGE BUT MAYBE THE EDGE IS RUSTED AND WARN AWAY. THE QUESTION IS WHETHER WE CAN DO ANYTHING TO GET THIS ISSUE IN EDGE AGAIN. WHETHER OR NOT THERE SHOULD BE AxD NATIONAL–r SYSTEM TO COMPENSATE RESEARCH SUBJECTS FOR RESEARCH RELATED INJURIES. AND IF YOU LOOK AT DOCUMENTS AND GUIDELINES AROUND THE WORLD, A LOT OF COUNTRIES NOW HAVE GUIDELINES THAT REQUIRE COMPENSATION IN VARIOUS SITUATIONS FOR RESEARCH RELATED INJURIES. UGANDA, BRAZIL HAS ONE, INDIA HAS ONE. LEGITIMATE WAN CIA, LOT VIA, UKRAINE HAS ONE. MOST OF EUROPE HAS ONE. THE EXPERIENCE AND THE HISTORY OF THIS IN THE UNITED STATES IS DECIDEDLY DIFFERENT. THIS ISSUE WAS TAKEN UP BY THE PRESIDENT'S COMMISSION IN 1979. WHO ARGUED COMPENSATION FOR RESEARCH RELATED INJURIES WAS A MATTER OF JUSTICE. AND AS A RESULT, THERE SHOULD BE THE DEVELOPMENT OF NATIONAL PILOT PROGRAMS TO SEE HOW WE COULD IMPLEMENT ON A NATIONAL LEVEL, COMPENSATION FOR RESEARCH RELATED INJURIES IN THE U.S. 20 YEARS LATER THE BIOETHICS ADVISORY COMMISSION MADE A REPORT NOTING THAT THOSE PILOT PROGRAMS HAD NEVER BEEN ATTEMPTED OR IMPLEMENTED. AGAIN CALLED AS A MATTER OF JUSTICE FOR SOME NATIONAL PROGRAM TO COMPENSATE FOR RESEARCH RELATED INJURIES. THAT LED TO A PERSPECTIVE IN THE NEW ENGLAND JOURNAL OF MEDICINE WHICH I'M GOING TO READ TO YOU, WHICH SAID IN THE UNITED STATES, THERE HAVE BEEN DECADES OF DISCUSSION AND„i RECOMMENDATIONS BY NATIONAL COMMISSIONS, SPONSORS, COMMENTATORS AND INSTITUTIONS THAT WILL SHOULD BE A NATIONAL SYSTEM TO COMPENSATE SUBJECTS FOUR RESEARCH RELATED INJURIES. THERE HAS BEEN RENEWED ATTENTION TO THIS ISSUE LATELY iAND THERE IS SOME HOPE IT MIGHT BE ADDRESSED. THAT PERSPECTIVE WAS PUBLISHED MAY 4, 2006 IN THE "NEW ENGLAND JOURNAL OF MEDICINE." IN 2011, THE CURRENT PRESIDENTIAL COMMISSION NOTED THAT AS A MATTER OF JUSTICE WE SHOULD THINK ABOUT COMPENSATION FOR RESEARCH RELATED INJURIES, AND QUOTE, THE COMMISSION RECOMMENDS THE UNDERTAKING OF A KALE ASSESSMENT -- CAREFUL ASSESSMENT TO ADDRESS HOW BEST TO SATISFY THE ETHICAL OBLIGATION TO COMPENSATE INDIVIDUALS THAT SUFFER RESEARCH RELATED INJURIES. QUICKLY, BRINGING YOU TO THE PRESENT AFTER ALL THOSE RECOMMENDATIONS, IF YOU GO ONLINE LIKE I DID TO SEE WHAT EXISTING POLICIES ARE, THIS IS A POLICY FROM ONE OF THE INSTITUTIONS THAT DOES THE MOST UNIVERSITY DOES THE MOST HUMAN SUBJECTS RESEARCH IN THE UNITED STATES. I WON'T NAME THE INSTITUTION. IT'S JUST NOT IDIOSYNCRATIC. IT EXEMPLIFIES WHAT GOES ON IN THE U.S. HERE IS THE POLICY. THEY PUT THIS IN THEIR CONSENT FORM. WE WILL PROVIDE ACUTE CARE THAT YOU NEED FOR ANY MEDICAL INJURIES THAT RESULT FROM THIS RESEARCH, AND WE WILL BILL YOU AND OR YOUR INSURANCE COMPANY FOR THAT CARE. UNIVERSITY SPONSORS DO NOT PROVIDE ANY OTHER SYMPTOMS OF COMPENSATION FOR RESEARCH RELATED INJURIES. SO THAT IS THE COUNTRY STATE OF COMPENSATION FOR -- CURRENT STATE IN THE UNITED STATES. AND TO DISCUSS THIS WE'LL START, AS I MENTIONED OUR CONSULTS OFTEN COME AND ARE THE PRECIPITATORS OF THESE GRAND ROUNDS. THIS IS THE FIRST ONE WHERE THERE WAS PRECIPITATED PIE A RESEARCH PARTICIPANT WHO YOU'RE GOING TO MEET IN A MOMENT, JARD BAETEN IS -- JEAN BURNS. SHE WAS NOT INJURED AS A RESULT OF A STUDY. SHE RAISED THIS CONSULT AND THIS CONCERN BECAUSE SHE IS CONCERNED ABOUT THE LACK OF AN EXISTING POLICY AND JEAN IS GOING TO DESCRIBE THIS THROUGH AN INTERVIEW WITH SCOTT KIM, A PSYCHIATRIST AND PHILOSOPHER, TO EMBARRASS HIM FOR A SECOND, SCOTT WAS HEAD OF A DEPARTMENT AT THE UNIVERSITY OF MICHIGAN FOR A LONG TIME. AND FORTUNATELY FOR US, JUST ABOUT A HALF AND A HALF AGO DECIDED TO LEAVE MICHIGAN AND JOIN OUR DISCUSSION. SO THANKS TO SCOTT AND JEAN. >> THANK YOU, CAN YOU HEAR ME? OKAY. JUST WANT TO MAKE SURE IT'S ON. SO JEAN, I'M GOING TO CALL YOU JEAN IF THAT'S OKAY. >> THAT'S FINE. I'LL CALL YOU SCOTT. >> THAT'S FINE. THAT'S WHAT WE HAVE BEEN DOING ANY WAYS. SO WHY DON'T WOE START. MAYBE YOU CAN TELL YOUR STORY ABOUT YOUR CONDITION, HOW YOU WERE DIAGNOSED. >> I HAVE PARKINSON DISEASE. I WAS DESIGNATED IN JANUARY OF ODIAGNOSED IN JANUARY, 2003. I HAD AN INTERMITTENT TREMOR IN ONE FINGER. HE SAID THAT WAS REALLY BAD. GAVE ME A CONSULT TO A NEUROLOGIST. TOOK ONE LOOK AT ME AND SAID YOU HAVE A BRAIN TUMOR OR YOU HAVE PARKINSON. AND I HAD PARKINSON'S DISEASE. AND IT WAS QUITE A BLOW. AT THAT TIME, I DIDN'T KNOW ANYONE WHO HAD PARKINSON'S DISEASE. I WAS QUITE DEPRESSED, DID A LOT OF SOBBING AFTER THAT. >> SO HOW DID YOU COPE WITH SUCH BAD NEWS? >> WELL, I'M A FORTUNATELIER WEB DEVELOPER. AND I TOLD MYSELF THERE HAS TO BE SOMETHING I CAN DO TO HELP MYSELF WITH THIS DISEASE. IT'S INCURABLE, IT'S PROGRESSIVE, OKAY, THERE ARE NO CURES.–r BUT I DID WEB SEARCHES, STUMBLED ACROSS CLINICAL RESEARCH, TRIALS AND STUDIES. THAT'S HOW I FIGHT THE DISEASE. THE FIRST -- I DID JOIN A CLINICAL TRIAL FOR A SUBSTANCE, 1437. IT WAS HOPED IT WOULD BE A CURE FOR PARKINSON DISEASE. IT FAILED AFTER TWO YEARS, FROM 2003 TO 2005. >> HOW MANY RESEARCH STUDIES HAVE YOU BEEN IN SINCE THEN? >> I HAVE BEEN IN AROUND TEN OR 15 RESEARCH STUDIES. BECAUSE WHEN I GIVE MY DATA, AND I -- I'M ADDING INFORMATION TO -- FOR RESEARCHERS. AND IT'S SHARED AROUND THE WORLD. AND I„i HOPE -- I THINK IT'S HELPING WITH RESEARCH. >> SO THE MOST OF THOSE STUDIES HAVE NOT BEEN CLINICAL TRIALS, BUT BASICALLY VOLUNTEERING YOUR BODY AND YOUR INFORMATION, CLINICAL. >> CORRECT. I KNOW I'VE GOT BLOOD, THEY'VE TAKEN BLOOD AND I FILL OUT FORMS, AND, YES. MOST OF THEM ARE NOT TRIALS. >> OKAY. HOW DID YOU END UP AT THE NIH. >> ABOUT EIGHT YEARS AGO, THERE WAS A STUDY IN -- EXCUSE ME, A TRIAL IN NAND FOR GNF. THAT WAS PHASE 1. THEN A PHASE 2 TRIAL IN KENTUCKY. AND I LATER -- THAT ENDED. I LATER MET SOME OF THE PARTICIPANTS WHO HAD BEEN INe1 THE KENTUCKY TRIAL. AND THEY WERE CONVINCED THAT IT HELPED THEM. SO I WAS -- I WAS CONVINCED, THEN, THAT I SHOULD PAY ATTENTION AND SEE IF OWHEN IT CAME BACK, WHICH I HOPED IT WOULD, THAT I WOULD LOOK INTO JOINING OR BEING PART OF A TRAIL FOR GDNF. THAT'S HOW THAT STARTED. >> SO YOU WERE PART OF A NETWORK OF PERSONS TO KEEP CLOSE TABS ON THE RESEARCH WORLD. >> YES. >> AND SO WHEN YOU HEARD ABOUT THIS PARTICULAR TRIAL, YOU VOLUNTEERED THEN. >> I DID. I ALSO HAD HEARD THAT THERE WAS A KINETICS STUDY WHICH MIGHT BE REQUIRED BEFOREHAND. AND SO I JOINED THAT. AND THEN I TOOK PAT IN -- I WAS ABLE TO APPLY FOR AND I WAS ACCEPTED INTO THE GDNF GENE THERAPY TRIAL. >> THE TRIAL YOU'RE IN NOW. >> CORRECT. >> CAN YOU WALK US THROUGH WHAT THAT INVOLVES? >> IT'S INVASIVE. IT REQUIRES MRI GUIDED SURGERY. I WAS IN SURGERY FOR 11 HOURS A SURPRISE FOR EVERY ONE. I HAVE TWO HOLES IN MY HEAD. THERE WAS INFUSION INTO FOUR PLACES INr-- IN ADDITION I HAVE A FIVE–r YEAR COMMITMENT TO PARTICIPATE IN THE TRIAL AND COME TO THE NIH. IT TAKES ABOUT 60 DAYS OF MY TIME TRAVELING AND BEING AT THE NIH FOR TESTS, LIKE 9 MRIS, 3 PET SCANS, GAL ZILL VIALS OF BLOOD. THREE LUMBAR PROCEDURES, NEURO PSYCHOLOGICAL EVALUATION. THERE ARE A LOST OF TESTS THAT GO THROUGH IN MY FIVE YEAR COMMITMENT. >> A LOT OF TIME COMMITMENT. ALSO ALLOWING SOMEBODY TO KIND OF GO DEEP INTO YOUR BRAIN AND INJECT THIS EXPERIMENTAL TREATMENT INTO YOUR BRAIN. YOU REMEMBER READING WHAT ALL THE -- YOU KNOW, THINGS THAT COULD GO WRONG? IN THAT KIND OF -- >> SURE. AFTER I READ THAT, AND READ WHAT THEY WOULD DO FOR ME, I NEARLY QUIT. THIS WAS BEFORE, BEFORE THE SURGERY. I ALMOST DIDN'T GO THROUGH WITH IT. BECAUSE EVEN THOUGH IT'S REMOTE CHANCE, BECAUSE IT IS BRAIN SURGERY, THERE IS A POSSIBILITY OF STROKE. POSSIBILITY OF SEIZURES. HEM RECONCILING. AND -- HEMORRHAGING. THE INFORMED CONSENT LISTED THE CLINIC WOULD TAKE CARE OF ME FOR 30 DAYS, AND THEN I WAS ALLOWED TO SUE THE FEDERAL GOVERNMENT. >> IF SOMETHING WENT WRONG. THAT'S WHAT IT WAS SAYING. IF THERE WAS A VERY SMALL CHANCE IF YOU GOT INJURED, THEY WOULD TAKE CARE OF YOU FOR 30 DAYSMENT AFTER THAT, YOU COULD SUE THE GOVERNMENT. >> RIGHT. >> I SEE. >> BECAUSE I'M A CHILD OF A PARENT WHO HAD HAD A STROKE, AND HAD TO GO INTO LONG TERM CARE, WHAT I HAD HOPED WOULD BE IN THIS WOULD BE PROVISION FOR CATASTROPHIC LONG TERM CARE IN CASE THAT WERE REQUIRED. I HAVE HEALTH INSURANCE. I WASN'T CONCERNED ABOUT THAT. BUT I DON'T HAVE LONG TERM CARE AND THAT ISN'T READILY -- I KNOW WHAT THE DIFFICULTIES THAT CAN PROVIDE FOR A PATIENT, FOR THEIR FAMILIES, AND DEALING WITH THIS. I DO WANT TO SAY THAT I SPOKE TO DR. HIEZE, THE PI FOR THIS TRIAL. AND HE HAD SAID THAT THIS WAS A BOILER PLATE. AND WHAT I UNDERSTOOD FROM THIS WAS THAT THIS IS POLICY. AND SO THIS DOESN'T HAVE ANYTHING TO DO WITH THE DOCTOR AND HIS TEAM. BECAUSE I HAVE RECEIVED SUBUSH CARE FROM THEM. WHEN I TALKED TO THE DEPARTMENT, IT WAS THE POLICY I WANTED TO TALK ABOUT AND HOPE TO CHANGE. >> AND WHEN WE TALKED EARLIER, YOU TALKED ABOUT HOW EVEN THOUGH YOU KNEW ABOUTok THIS, YOU WENT THROUGH THE SURGERY AND RESEARCH STILL, AND WHY DON'T YOU TALK ABOUT WHY? >> OKAY. THE TRUTH IS AFTER 12 YEARS, I WAS RAPIDLY DECLINING. ANDIVITIES AFRAID FOR MY HEALTH. I WAS AFRAID FOR MY FUTURE. AND I HOPED, I HOPED THAT THIS WOULD HELP ME. NOW, WHAT I KNOW IS THAT MOST CLINICAL TRIALS FAIL. AND SO THE ODDS ARE–r AGAINST ME. BUT I ALSO KNOW THAT IF THE TRIAL FAILED, MY INFORMATION, MY DATA WOULD STILL BE OUT THERE AND WOULD HELP THE PARKINSON'S COMMUNITY. AND IT WOULD HELP PEOPLE WITH PARKINSON'S WHO FOLLOW ME. I JUST HOPE THAT AT SOME POINT THERE IS A SAFETY NET FOR PEOPLE THAT TAKE THESE RICKS, AND ARE PART -- RISKS AND ARE PART OF THE CLINICAL TRIAL. >> AT THAT POINT SHE CAME TO OUR DEPARTMENT THROUGH A CONSULT. AS YOU CAN TELL JEAN IS A VERY COMPELLING PERSON WHO VERY ARTICULATELY DISCUSSED HOW SHE HOPED THAT FOR PEOPLE THAT VOLUNTEER TO HAVE THEIR -- LITERALLY HAVE THEIR HEAD DRILLED OPEN, THAT ALTHOUGH ALL PRECAUTIONS ARE TAKEN, THERE IS ONLY A VERY SMALL CHANCE ANYTHING REALLY BAD COULD HAPPEN, THAT THERE WOULD BE SOME SAFETY NET. YOU WERE SURPRISED THERE WASN'T ONE. >> YES. >> AND WE DISCUSSED THAT THIS IS A POLICY ISSUE. AND THOUGHT THIS WOULD BE REALLY EXCELLENT TOPIC, NOT JUST ABOUT THE CLINICAL CENTER. THIS IS A NATIONAL POLICY ISSUE. WE THOUGHT IT WOULD BE A GOOD SESSION FOR TODAY'S ROUNDS. THANK YOU, JEAN. [APPLAUSE] >> THANK YOU, JEAN. WE HAVE TIME -- IS THERE ONE OR TWO QUICK QUESTIONS FOUR SCOTT OR JEAN BEFORE WE MOVE ON? IT'S ALL RIGHT. SO MAYBE WE WILL MOVE ON AND THEN WE CAN CIRCLE BACK IF ANYBODY HAS QUESTIONS LATER. A REMINDER, THESE SESSIONS ARE STREAMED ON TO THE WEB. WE HAVE BEEN GETTING 300 TO 400 PEOPLE A SESSION. WHEN YOU DO HAVE A QUESTION, IF YOU CAN MAKE IT TO THE AISLE MICS AND SPEAK INTO THE MIC, THAT WOULD BE GREAT. SO UNFORTUNATELY, I HAVE VERY BAD NEWS FOR EVERYBODY. THE NIH SECURITY WASN'T SUFFICIENTLY STRINGENT TO KEEP KEN FOR AN HOUR. WHAT THAT MEANS, IT DEPRIVES ME OF ME GIVING YOU A SONG AND DANCE RENDITION, TO SEE IF YOU AGREE WITH MY FRIENDS THAT I HAVE THE WORSE SINGING VOICE IN THE HISTORY OF THE WORLD. INSTEAD, WE'LL HEAR FROM KEN. MAYBE THAT'S ANOTHER TIME. INSTEAD, TO DISCUSS THIS, I THINK VERY INTERESTING IMPORTANT ISSUE WE'RE LUCKY TO HAVE KELLI HUELER WHO IS A LAWYER -- KEN FEINBERG, WHO IS A LAWYER. PROBABLY HAD AS MUCH EXPERIENCE IN THE U.S. BEING INVOLVED IN COMPENSATION FUNDS AS ANYBODY. KEN IS THE ADMINISTRATOR OF THE SEPTEMBER 11 VICTIM'S FUND FOR VICTIMS OF THE BOMBINGS IN NEW YORK AND SEPTEMBER 11. ALSO THE ADMINISTRATOR FOR THE BP DEEP WATER HORIZON DISASTER FUND. AND HE'S ALSO AN ADMINISTRATOR, I DON'T KNOW HOW HE'S DOING ALL THIS STUFF, AND ALSO GETTING HERE, BUT HE'S ALSO THE ADMINISTRATOR FOR THE ONE FUND, WHICH HAS BEEN A FUND SET UP FOR VICTIMS OF THE BOMBING AT THE BOSTON MARATHON. THANK YOU FOR JOINING IS, GREAT YOU COULD MAKE IT. >> THANK YOU VERY MUCH. THANK YOU ALL. [APPLAUSE] >> OKAY. A 20 MINUTE SUMMARY OF A VERY COMPLICATED PROVOCATIVE TOPIC. SHOULD YOU COMPENSATE SUBJECTS OF RESEARCH RELATED INJURY? YOU KNOW BETTER THAN I -- WHEN YOU ASK THAT QUESTION, BE PREPARED TO BREAK IT DOWN. AND DEAL WITH THE FOLLOWING ISSUES. AS I DEAL WITH THESE ISSUES EVERY DAY. NOW THE GM IGNITION SWITCH, ONE FUND BOSTON. VIRGINIA TECH, THE SHOOTINGS AT VIRGINIA TECH, THE SHOOTINGS IN ARROWA, COLORADO. DARK KNIGHT MOVIE. THERE ARE VARIOUS COMPENSATION FUNDS. NEW TOWN CONNECTICUT. THOSE FIRST GRADERS THAT WERE KILLED. THERE ARE VARIOUS PROGRAMS TO COMPENSATE INNOCENT VICTIMS OF TRAGEDY. ALL THESE PROGRAMS COMPEL EACH OF YOU INTERESTED IN THE TOPIC, TO ASK THE FOLLOWING QUESTIONS. ONE, DO THE POLICYMAKERS WANT SUCH A FUND CREATED? WHO ARE THE POLICY MAKERS? THE CONGRESS? 911. ONE FUND BOSTON, MAYOR MENINO IN BOSTON. BP, PRESIDENT OBAMA. GM, THE CONGRESS IN GM. I MEAN WHEN YOU RAISE THE ISSUE OF COMPENSATION, ASK YOURSELF FIRST AND FOREMOST YOUR DOCTORS AND ETHICISTS, I'M A LAWYER, WE DON'T DECIDE WHETHER TO CREATE THESE FUNDS. WHERE IS THE MONEY COMING FROM? IS THERE A TAX? ON RESEARCH RELATED SUBJECTS? IS IT TAX PAIR MONEY FROM THE GENERAL COIFFEURS? IS IT PART OF THE NIH BUDGET? I DON'T KNOW. I'M NO EXPERT. BUT YOU HAVE TO PRELIMINARY, BEFORE YOU GET INTO THE HARD ISSUES, WHO WANTS SUCH A FUND? WHO IS PROMOTING SUCH A FUND? WHERE IS THE MONEY COMING FROM? AND HOW MUCH MONEY IS THERE? HOW MUCH MONEY DRIVES EVERYTHING? YOU CAN'T GIVE -- YOU CAN'T SAY I WANT TO COMPENSATE VICTIMS AND THEN GIVE THEM $1.60. IS THERE ENOUGH MONEY TO COMPENSATE VICTIMS? EVEN IF YOU WANT TO DO IT? THESE ARE VERY HARD PRACTICAL QUESTIONS. 9/11, I HAD AN OPEN ENDED BUDGET. CONGRESS AUTHORIZED A COMPENSATION PROGRAM AND THEN SAID BUT WE DON'T KNOW HOW MUCH IT WILL COST. WE HAVEN'T DONE THIS BEFORE. KEN WILL DECIDE. THAT'S NICE TO KNOW. OPEN ENDED. I DON'T HAVE TO TAKE FROM PETER TO PAY PAUL. BP, PB ST% PRESIDENT OBAMA, $20 BILLION TO CLEAN UP THE GULF TO PAY COMPENSATION. IN THE GULF. $20 BILLION, THE MINUTE I WAS APPOINTED -- I KNEW THAT'S OPEN ENDED. YOU'RE NOT GOING TO SPEND $20 BILLION ON A COMPENSATION PROGRAM. IT'S IMPOSSIBLE. ONE FUND BOSTON, PRIVATE DONATIONS CAME IN FROM ALL OVER THE COUNTRY. $61 MILLION RAISED IN 60 DAYS. WE DISTRIBUTE THAT MONEY. THOSE ARE SOME PRELIMINARY QUESTIONS. THEN YOU GET INTO THE -- AND REMEMBER, REMEMBER, YOU MAY ALL SAY THAT RESEARCH VICTIMS, TERRIBLE SIDE EFFECTS, TERRIBLE. THEY OUGHT TO BE COMPENSATED. WELL, BE CAREFUL WHEN YOU SAY THAT. BAD THINGS HAPPEN TO GOOD PEOPLE EVERY DAY IN THIS COUNTRY AND THEY'RE NOT COMPENSATED THROUGH SOME SORT OF FUND. THERE HAS TO BE A PUBLIC POLICY BASIS, AN END GAME, AN OBJECTIVE. WHEN YOU COMPENSATE RESEARCH VICTIMS. EVERY DAY INNOCENT PEOPLE ARE HARMED AND INJURED IN THIS COUNTRY. THERE IS NO 9/11 FUND. THERE IS NO ONE FUND BOSTON. WHY THIS PARTICULAR AREA? WHAT ARE THE MOTIVATIONS AND THE LONG TERM GOALS THAT JUSTIFY CREATING COMPENSATION IN A CASE LIKE THIS? IT'S UP HILL CHALLENGE. YES, ONE FUND -- YES, 9/11, YES BP, YES, ONE FUND. NO A. NO B. NO C. BE PREPARED TO HEAR CRITICISM THAT IT'S UNFAIR, WHY THESE PEOPLE BUT NOT THESE PEOPLE. BUT OKAY. THAT'S SORT OF A PHILOSOPHIC OVERHEAD. THEN YOU GET INTO THE SPECIFIC ISSUES THAT YOU'VE GOT TO ADDRESS IN CREATING SUCH A SYSTEM, ASSUMING THERE IS A GROUND SWELL TO HAVE SUCH A SYSTEM. ONE, WHO IS ELIGIBLE? WHO IS ELIGIBLE? TO RECEIVE COMPENSATION? NOW, WHEN I SERVED ON PRESIDENT CLINTON'S COMMISSION TO COMPENSATE THE VICTIMS OR THE INNOCENT VICTIMS OF RADIATION TESTING IN THE COLD WAR, NONE OF THOSE VICTIMS EVER GAVE KNOWING CONSENT. IT WAS EASY. RELATIVE HEY SPEAKING. THE RESEARCH VICTIMS RECEIVED SOME LETHAL DOSES OF RADIATION DURING THE COLD WAR WITHOUT EVER SIGNING ANYTHING OR KNOWING OF THE TREATMENT. THEY WERE TERMINALLY ILL CANCER PATIENT. THEY ALL WOULD HAVE DIED ANYWAY. BUT THEY NEVER GAVE THEIR CONSENT. I THINK THERE WERE 23 OF THEM. CONGRESS PASSED A LAW AND PAID THEM. COMPENSATION. FOR THE ABSENCE OF CONSENT PAID TO THE FAMILIES, EVEN THOUGH TERMINALLY ILL. BUT IT IS A VERY DIFFICULT QUESTION THE FIRST ISSUE ELIGIBILITY. WHEN SOMEBODY SIGNS A FOOL, IS–r IT AN UNCONSCIONABLE WAIVER, WHEN SIGNS A FORM SAYING I'M A SUBJECT RESEARCH. I GIVE UP ALL MY RIGHTS. I WON'T SUE. WHERE DO I SIGN? QUICK! ARE THEY UNDER DURESS? ARE THEY UNDER DURESS, IS THAT FORM WORTH ANYTHING? AND EVEN IF IT IS A VALID KNOWING CONSENT, WHAT DO WE MEAN BY RESEARCH RELATED? I'M GOING TO UNDERGO THIS SPECIAL TREATMENT BECAUSE IT WILL DO A, B, C TO MY BODY. YES, I SIGN. I SIGN. RESULT. DE AND F. NOT A, B, C. A MORE PERVASIVE INJURY. SOMETHING NOT CONTEMPLATED. WITHIN THE DOMAIN OF SCIENCE, WHO KNOWS? SO IF YOU WANT TO SET UP A COMPENSATION PROGRAM, IS ELIGIBILITY LIMITED TO THOSE VERY FEW PEOPLE WHO DON'T CONSENT? ETHICAL VIOLATIONS. OR, NO, NO, NO. IS A PUBLIC POLICY ENCOURAGING SUCH RESEARCH, ENCOURAGING THESE CONSENTS? SO THERE OUGHT TO BE A LIMITATION MAYBE ON COMPENSATION OR RECOVERY, BUT YES, THE FORM SHOULD NOT IMMUNIZE THE RESEARCHERS FROM SOME SORT OF OBLIGATION TO PAY. I'M NOT AN EXPERT. BUT I SUSPECT BASED ON EXPERIENCE, DETERMINING ELIGIBILITY FOR COMPENSATION IS A VERY SOPHISTICATED DIFFICULT ASSIGNMENT. ETHICALLY AND PRACTICALLY, WHAT ARE THOSE CRITERIA? SECOND, LET'S ASSUME YOU ARE ELIGIBLE. WHAT IS THE AGREED UPON METHODOLOGY FOR CALCULATING DAMAGES? CALCULATING COMPENSATION? HOW DO YOU DECIDE, ALL RIGHT, YOU'RE ELIGIBLE, YOU'RE HARMED. YOU'RE GOING TO GET WHAT? ON WHAT BASIS ARE YOU CALCULATING THE REMEDY? IS IT A TORT BASED PROGRAM? LIKE YOU WOULD IN A COURTROOM? IS IT A WORKERS COMPENSATION MODEL WHERE EVERYBODY WHO IS HARMED BASICALLY GETS A FLAT AMOUNT, HERE IT IS, IT'S CAPPED, THAT'S IT? DETERMINING THE -- EVEN IF YOU GET OVER THE ELIGIBILITY PROBLEM, DETERMINING WHAT IS APPROPRIATE COMPENSATION -- I MEAN A RESEARCH VICTIM MAY SAY I WAS HARMED IN A MANNER NEVER ANTICIPATED OR FORESEEN, AND I WANT $10 MILLION. LIKE I HIT THE JACKPOT WITH A JURY IN MONTGOMERY COUNTY. OR, NO, NO, UNDER OUR PROGRAM WE WILL GIVE YOU NO CHECK. WE WILL GIVE YOU SERVICE IN KIND. WE WILL SERVE -- WE WILL DEAL WITH THE ADVERSE CONSEQUENCES WITHOUT COST. WE'LL GIVE YOUf‡ A CHECK FOR $2,500. $25,000. BUT FORGET THE AMOUNT. WE'RE GOING TO CALCULATE -- WE HAVE TO DETERMINE THE METHODOLOGY THAT'S GOING TO BE USED TO DEFINE COMPENSATE. SECOND ISSUE. THIRD. WHAT ARE THE PROOF REQUIREMENTS THAT A VICTIM COMES FORWARD TO DEMONSTRATE MY MALADY, MY INJURY, MY ILLNESS IS A CONSEQUENCE OF THE RESEARCH? VERSUS PURE FOR TOOTY. -- FOR TO YOUTY. YOU WOULD HAVE GOT THIS ANYWAY. IT'S NOT THE RESEARCH RELATED DIAGNOSIS AND TREATMENT. YOU WERE ALREADY SUFFERING FROM EPILEPTIC SEIZURES. THE RESEARCH HAD NO REAL -- DIDN'T TRIGGER YOUR INJURY. OR PROVE IT. PROVE IT. 1200% THE CAUSE. 50% THE CAUSE. 25% THE CAUSE. 10% THE CAUSE. BY WHAT STANDARD? PROOF, NOT METHODOLOGY. WE MAY HAVE THE BEST METHODOLOGY IN THE WORLD. THE CLAIMANT STILL HAS TO COME FORWARD OR DOES HE OR SHE HAVE TO COME IN FORWARD. IN MY CASE, HERE IS MY EVIDENCE. PAYMY. VERSES I CAN'T MAKE OUT THE CASE. I'M NOT ELIGIBLE. FOUR. WHAT ARE THE CONSEQUENCES OF TAKING THE COMPENSATION? MRS. JONES, YOU'RE ELIGIBLE. WE HAVE A METHOD ROLL. YOU'VE PROVEN YOUR CASE. HERE IS A CHECK FOR X. NOW, IN RETURN, SIGN THIS DOCUMENT. YOU WILL NOT SUE INH, YOU WILL NOT SUE NIH, YOU WILL NOT SUE THE RESEARCHERS, YOU WILL NOT SUE THE DOCTORS, THE LAWYERS ARE GREAT. DIRECTLY, INDIRECTLY. AIREST, PREDECESSORS, FUTURE INTO THE YEAR 2150. NO ONE IS GOING TO SUE ME. IN RETURN HERE IS A CHECK. WELL, WHAT RIGHTS IF ANY ARE RELINQUISHED IF YOU DECIDE TO COMPENSATE? WHAT IS THE SCOPE OF THE RELEASE IF YOU ACCEPT THE COMPENSATION? BIG ISSUE. 9/11, BP AND GM. YOU CAN GET MILLIONS OF DOLLARS IF YOU'RE ELIGIBLE, AS LONG AS YOU PROMISE NOT TO SUE THE UNITED STATES OR THE AIRLINES OR GM OR BP. THAT'S THE DEAL. ONE FUND BOSTON OR RUSSIA COLORADO, THAT'S A GIFT -- AURORA COLORADO, THAT'S A GIFT. YOU CAN HIRE A LAWYER WITH THE MONEY IF YOU WANT. NOBODY DOES BY YOU COULD. I'M INTRIGUED WHY PEOPLE DON'T. BUT NEXT. ANY PROGRAM, NEXT QUESTION. YOU'RE ELIGIBLE, WE HAVE A METHODOLOGY, YOU MADE YOUR CASE. WHAT ARE THE DUE PROCESS REQUIREMENTS ASSOCIATED WITH A COMPENSATION PROGRAM? DO YOU GIVE RESEARCH SUBJECTS THE OPPORTUNITY TO BE HEARD? AT A HEARING? WHO IS PRESIDING OVER THE HEARING? IS THERE AN ADMINISTRATOR? INDEPENDENT? WHO HAVE ACCEPT EVIDENCE OR HEAR FROM BOTH SIDES? WHAT ARE THE PROCEDURAL DETAILS OF A COMPENSATION PROGRAM? MRS. JONES YOU'RE ELIGIBLE, YOU OFFERED PROOF BUT WE DON'T THINK THE PROOF HOLD UP AND WE'RE NOT GOING TO PAY YOU. I WANT TO APPEAL. APPEAL TO WHO? WHO MADE THE INITIAL DECISION AND WHO WILL NOW REVIEW THAT DECISION, IF ANYBODY? IN MY PROGRAMS THERE IS NO APPEAL. IT'S VOLUNTARY. YOU CAN TAKE THE MONOGYNYBERG OFFERS IN 9/11 -- TAKE THE MONEY FEINBERG OFFERS. IF I DON'T LIKE IT, DON'T TAKE IT. YOU CAN SUE. IF YOU TAKE THE MONEY YOU SIGN A RELEASE. IF YOU DON'T LIKE FEINBERG'S DECISION, TOO BAD. THERE IS NO PROCEDURAL HIERARCHY WHERE YOU GIVE PEOPLE ADDITIONAL RIGHTS TO LITIGATE. SO A BIG ISSUE HERE IS INFRASTRUCTURE. WE'RE ALL TALKING SUBSTANCE. BUT DO NOT UNDER-ESTIMATE THE CHALLENGES POSED BY CREATING A FAVORABLE ANSWER TO THE QUESTION. ALL RIGHT. OKAY. YES. THERE SHOULD BE A NATIONAL SYSTEM TO COMPENSATE SUBJECTS FOR RESEARCH RELATED INJURY. YES, SHOULD BE. WHO IS ADMINISTERING THE PROGRAM? UNDER WHO'S UMBRELLA? WHAT ARE THE PROCEDURAL NICETIES? HOW ADVERSARIAL IS THE PROGRAM? DO YOU NEED A LAWYER? A HEARING EXAMINER? WHO PROCESSES THE CLAIMS? WHAT ARE THE CONSEQUENCES OF AN -- IS THERE AN APPEALS PROCESS. >> IF YOU DON'T LIKE THE RESULT? WE COULD SPEND A WHOLE SEMESTER OR A WHOLE YEAR AROUND A TABLE AT NIH TRYING TO GET ANSWERS TO THESE QUESTIONS. IT ALL STARTS WITH THE MONEY. YOU KNOW WHY. IF YOU'VE GOT A VERY LIMITED BUDGET THEN YOU'RE GOING TO MAKE IT VERY DIFFICULT BY DEFINITION. YOU'RE GOING TO MAKE IT VERY DIFFICULT FOR PEOPLE TO BE DEEMED ELIGIBLE. YOU ONLY HAVE SO MUCHe1 MONEY. SO WE OUGHT TO RESERVE A LIMITED POT TO A VERY FEW ELIGIBLE DEFINED PEOPLE. THE MORE MONEY YOU HAVE, THE MORE IT'S PART OF SORT OF LIKE AN OPEN ENDED BUDGET WHERE WE DON'T HAVE TO LIMIT ELIGIBILITY SO NARROWLY OR RESTRICTIVELY. YOU BROADEN THE DEFINITION OF ELIGIBILITY. YOU SEE, TO ME, IN ALL OF MY COMPENSATION PROGRAMS, ONE OF THE REAL CHALLENGES IS DETERMINING ELIGIBILITY. MR. FEINBERG, I WAS PUTTING A PAINTING UP ON MY WALL AT MY APARTMENT ON EAST 94th STREET. FIVE MILES FROM THE WORLD TRADE CENTER. WHEN I SAW THROUGH MY WINDOW THE PLANE HIT THE WORLD TRADE CENTER, I FELL OFF MY STOOL AND BROKE MY ARM. I AM PHYSICALLY INJURED AS A RESULT OF THE 9/11 ATTACKS. I DEEM YOU INELIGIBLE. THAT'S AN OUTRAGE. THAT'S NOT WHAT CONGRESS MEANT WHEN IT SAID THE IMMEDIATE VICINITY OF THE 9/11 ATTACKS. MR. FEINBERG, I LIVE IN JERSEY CITY. WHEN THOSE WORLD TRADE CENTER TOWERS COLLAPSED, THE DUST AND THE GUB WATCHED -- WAFTED OVER THE HUDSON. I WAS BREATHING IT FOR THREE DAYS, NOW EMPHYSEMA. PAY ME. NO, NO, IMMEDIATE VICINITY DOESN'T MEAN ACROSS THE HUDSON RIVER M WELL, I HAVE A CLAIM. GO SUE IF YOU HAVE A CLAIM. BUT I CAN'T PAY YOU. I CAN'T PAY YOU. THERE FEINBERG, I LOST $100,000 BECAUSE I COULDN'T FISH BECAUSE OF THE BP OIL SPILL. OKAY. WHAT DO YOU HAVE TO SHOW ME THAT YOU LOST 100 -- WE DO THINGS WITH A HANDSHAKE DOWN HERE IN THE GULF. WELL, DO YOU HAVE A TAX RETURN? NO. DO YOU HAVE A PROFIT AND LOSS STATEMENT. HERE IT IS IN CRAYON. ALL RIGHT. WE'RE GOING TO SEND YOU A CHECK FOR $100,000. WITH IT, YOU'RE GOING TO GET A 1099 FROM THE IRS. I AM? I WAIVE IT. YOU CAN'T WAIVE A 1099. I HAVE TO SEND YOU THE 1099. I WITHDRAW MY CLAIM. PROBABLY NEVER PAID TAXES IN HIS LIFE. ELIGIBILITY. METHODOLOGY. PROOF. DUE PROCESS. THE NATURE OF THE RELEASE. THE INFRASTRUCTURE. THE PROCEDURES YOU'RE GOING TO SET UP. VERY, VERY DEEP WATER. IT'S EASY WHEN THE RESEARCH VICTIM HAS NOT CONSENTED. THAT IS AN ABERRATION, LET'S FACE IT. IT MAY HAPPEN. I DON'T KNOW THE WORLD THE WAY YOU GUYS. BUT WHAT ABOUT ALL OF THESE RESEARCH VICTIMS WITH ADVERSE CONSEQUENCES?sKE IT'S ONE THING TO SAY TO SOMEBODY IN LONDON, AFTER THE LONDON SUBWAY BOMBINGS, YOU'RE AN INNOCENT VICTIM AND WE'RE GOING TO GIVE YOU $5,000. IN 9/11, YOU'RE AN INNOCENT VICTIM AND WE'RE GOING TO GIVE YOU $5 MILLION. A HUGE DIFFERENCE. DRIVEN BY THE TORT SYSTEM. SO I'M GLAD TO LOOK AT SOME OF THE CONCEPTUAL MODELS ABROAD. I FOUND IN MY WORK IT'S THE DOLLARS THAT PEOPLE FOCUS ON, AS MUCH AS ANYTHING. >> YOU HAVE A VERY UNUSUAL RESUME AS WE'VE SEEN. CAN YOU TELLUS ABOUT YOUR TRAINING AND HOW -- >> I'M FROM BOSTON. [LAUGHTER] >> AND HOW YOU GOT TO BE THE PERSON EACH GOES TO? >> I NEVER, EVER -- I'M A CLASSIC EXAMPLE OF SOMEBODY WHO IS ALWAYS -- WHO ALWAYS TELLS PEOPLE, DON'T ASSUME YOU'RE GOING TO BE SOMETHING TWO YEARS FROM NOW. LIFE HAS A WAY OF MODIFYING YOUR BEST LAID PLANS. I GOT INTO THIS BY ACCIDENT. THE JUDGE IN BROOKLYN WHO WAS HANDLING THE VIETNAM VETERAN'S AGENT ORANGE LITIGATION, I KNEW HIM. WE HAD BOTH -- WE HAD BEEN FRIENDS. HE ASKED ME TO MEDIATE A SETTLEMENT OF THAT CASE. AND THEN TO DESIGN AND IMPLEMENT A PROGRAM TO DISTRIBUTE THE SETTLEMENT PROCEEDS. I HAD NEVER HAD MEDUATION, NEVER DESIGNED. I KNEW NOTHING ABOUT SYSTEMS DESIGN. THAT WAS 35 YEARS AGO. AND ONCE I DID THAT, FRONT PAGE NEWS, EVERYBODY STARTED CALLING ME. WE'VE GOT A TRAGEDY. WILL YOU HELP US? AND IT WAS PURELY BY ACCIDENT, IT WAS NEVER PLANNED. I TELL PEOPLE, ESPECIALLY YOUNG PEOPLE, DON'T WORRY TOO MUCH ABOUT WHAT YOU'RE GOING TO BE DOING IN TWO YEARS. ENJOY WHAT YOU'RE DOING NOW. AND LIFE WILL TAKE CARE OF THE REST. >> DID YOU HAVE A QUESTION? >> HI. >> SORRY. IS THE SECOND MIC WORKING? >> WHEN I CAME FORWARD. >> IT'S JEAN RIGHT IN FRONT OF YOU. >> OH. WHEN I CAME AND SPOKE TO THE BIOETHICS DEPARTMENT, COMPENSATE WAS NOT IN MY VOCABULARY. I WAS LOOKING FOR INSURANCE AND INSURANCE POLICY. AS A PATIENT, BELIEVE ME, I'M NOT ASKING FOR A CHECK FOR WHATEVER IF SOMETHING HAPPENS TO ME. BUT I DO BELIEVE THAT SOME INSURANCE -- I THINK WE CAN ALL ACKNOWLEDGE, IF I UNDERGO BRAIN SURGERY AND HAVE A STROKE ON THE TABLE, THAT WAS RESEARCH RELATED. IF I HAVE A HEMORRHAGE ON THE TABLE, THAT WAS RESEARCH RELATED. THAT'S WHAT I WAS LOOKING FOR. THAT WAS MY QUESTION. AND SO FOR METIOUS THIS IS A LITTLE BIT OFF TOPIC. I CERTAINLY RESPECT EVERYTHING YOU'VE DONE. NOW, THE OTHER THING I WANT TO SAY IS AS A PATIENT WHO SIGNED THIS ANYWAY, YOU HAVE TO ACKNOWLEDGE THAT YOU MAY BE DEALING WITH PATIENTS WHO ARE DESPERATE FOR BETTER TREATMENTS OR A CURE. AND SO SOMETIMES THIS IS OUR ONLY RECOURSE. AND MY THIRD POINT. FORGIVE ME, SIR. IS DO OUR RESEARCHERS WANT TO CONTINUE TO RUN CLINICAL TRIALS AN STUDIES? DO THEY WANT TO CONTINUED TO HAVE PATIENTS VOLUNTEER? BECAUSE IF WE'RE NOT TREATED WELL, WE MAY DRY UP. >> NOW, THAT LAST POINT THAT YOU MAKE IS ONE OF THE PUBLIC POLICY OBJECTIVES, I GUESS, OF COMPENSATION. ONE, WE WANT TO ENCOURAGE THIS TYPE OF RESEARCH. BY MAKING SURE THAT PATIENTS WHO WILLINGLY UNDERTAKE THIS STATE OF THE ART RESEARCH, NEED NOT FEAR ABOUT DOWN STREAM FINANCIAL CONSEQUENCES. I DON'T KNOW THE EXTENT OF THAT. BUT IS THAT A POLICY OBJECTIVE? DOES COMPENSATING VICTIMS OF RESEARCH RELATED INJURY IF COURAGE PEOPLE -- ENCOURAGE PEOPLE TO ENGAGE IN THIS? AND FROM THE OTHER SPECTRUM, I THINK YOU'RE ABSOLUTELY RIGHT. TO WHAT EXTENT DO RESEARCHERS WANT SOME IMMUNIZATION, SOME PROTECTION FROM THE POTENTIAL FALLOUT OF LITIGATION? I MEAN SIGNING A DOCUMENT UNDER DURESS MAY NOT IMMUNE NICE RESEARCHERS. IMMUNIZE RESEARCHERS FROM A CREATIVE LAWYER WHO SAYS THAT CONSENT FORM ISN'T WORTH THE PAPER IT'S WORTH ON. TO WHAT EXTENT DOES A CAREFULLY CRAFTED COMPENSATION PROGRAM BENEFIT THE PUBLIC? THE VICTIM, THE RESEARCHER? THAT'S THE CHALLENGE. >> I WAS WONDERING IF YOU COULD ELABORATE ON YOUR CLAIM THAT WE SHOULD DROP THE WORDS JUSTICE AND FAIRNESS FROM OUR VOCABULARY. YOU SAID THAT, THEN LATER I SAID THIS ISSUE RAISES IMPORTANT POLITICAL PHILOSOPHICAL QUESTIONS WHICH I WOULD HAVE THOUGHT ARE QUESTIONS HOW TO FAIRLY DISTRIBUTE SCARCE RESOURCES IN THIS KIND OF CASE. AND SO I WONDER IF YOU COULD SAY MORE ABOUT THAT. >> YOU SHOULD HAVE READ SOME OF THE E-MAILS I RECEIVED DURING THE 9/11 FUND. MY SON DIED IN OKLAHOMA CITY. WHERE IS MY CHECK DEAR MR. FEINBERG, I DON'T GET IT. MY DAUGHTER DIED IN THE BASEMENT OF THE WORLD TRADE CENTER IN THE ORIGINAL 1993 ATTACKS COMMITTED BY THE VERY SAME PEOPLE. WHERE IS MY CHECK? AND IT WASN'T JUST TERRORISM. DEAR MR. FEINBERG. I DON'T UNDERSTAND. LAST YEAR, MY DAUGHTER SAVED 3 LITTLE GIRLS FROM DRAWING IN THE MISSISSIPPI RIVER, AND THEY SHE DROWNED A HEROIN. WHERE IS MY CHECK? YOU BETTER BE CAREFUL ABOUT SETTING UP COMPENSATION PROGRAMS THAT HELP ONLY THE CHOSEN FEW. EVERYBODY ELSE FEND FOR YOURSELF. EVEN IF YOU'RE ELIGIBLE, DEAR MR. FEINBERG, MY HUSBAND DIED AT THE WORLD TRADE CENTER A FIREARM, A HERO! YOU'RE GIVING ME $2 MILLION DOLLARS, BUT GIVING ME NEIGHBOR 3 MILLION-DOLLAR. BECAUSE HER HUSBAND WAS A BANKER FOR ENRON. I DON'T GET IT. WHY ARE YOU GIVING -- EVERYBODY COUNTS OTHER PEOPLE'S MONEY. EVERYBODY DOES. IT'S HUMAN NATURE. I THINK YOU'RE IN DEEP WATER, IF YOU TRY AND SAY THAT THESE PROGRAMS ARE JUST. OR FAIR. WHAT'S FAIR ABOUT A PROGRAM LIKE THIS? M FEINBERG, YOU'RE GOING TO GIVE ME 2 MILLION DOLLARS BECAUSE I LOST BOTH MY LEGS AT THE BOSTON MARATHON BOMBINGS. I GOT A BETTER IDEA. YOU'RE THE ADMINISTRATOR. KEEP THE MONEY AND GIVE BE MY LEGS BACK. THAT'S WHAT I WANT. I DON'T WANT THE MONEY. IT'S NOT FAIR AND IT'S NOT JUST. I HAVE NO LEGS. I WANT MY LEGS BACK. NOW, THERE IS VERY LITTLE I CAN SAY. VERY LITTLE YOU CAN SAY. I THINK THESE PROGRAMS MAY BE MERCIFUL, BUT I WOULDN'T WANT TO ETHICALLY DEFEND THEM AS JUSTICE OR FAIRNESS. WHEN THERE ARE THOUSANDS OF PEOPLE WHO ARE JUST AS INNOCENT, THEY'RE NOT EVEN ELIGIBLE. UNDER THE PROGRAM WE'RE TALKING ABOUT HERE. THEY WILL -- I'M ASSUMING THERE WILL BE RESEARCH VICTIMS THAT WILL NOT BE ELIGIBLE. WHAT'S FAIR ABOUT IT? >> DAVID. >> LOOKING AT THE TITLE ON THIS PROGRAM, WOULD A MORE ANALOGOUS PROGRAM BE ONE THAT EXISTS IN A DIFFERENT OPERATING DIVISION DOCTOR HHS, THE NATIONAL VACCINE COMPENSATION PROGRAM. IT'S THE SAME WAS IT RELATED, DO I GET IT, DO YOU NOT? MORE AN ANIMALGY OF A FEDERALLY ADMINISTERED PROGRAM RIGHT NOW THAT IS INTENDED TO HAVE A PUBLIC HEALTH BENEFIT IN THAT VACCINE COMPANIES WON'T GO OUT OF BUSINESS, PEOPLE HAVE SAFETY THING, I MEAN -- >> I GUESS. IT'S ANALOGOUS. MORE RELEVANT. DON'T TOUT THE VACCINE PROGRAM AS A STUNNING SUCCESS. I MEAN I THINK IT'S BETTER THAN LITIGATION. BUT UNDERSTAND THAT VACCINE PROGRAM IS FRAUGHT WITH ADVERSARIALNESS, COMBATIVENESS. IT'S AS MUCH LITIGABLE AS WORKERS COMP OR SOMETHING. NOWHERE NEAR AS STREAMLINED AS BP OR 9/11 OR GM OR ONE FUND BOSTON. THERE ARE HUGE PROBLEMS OF PROOF. AND -- BUT YES, I THINK THE VACCINE PROGRAM IS ONE OF A NUMBER OF PROGRAMS. THE PROGRAMS ARE ADMINISTERED, THE VACCINE PROGRAM. WORKERS COMPENSATION, 50 STATES. THAT OUGHT TO BE EXAMINED. WHAT ARE RESTRAINTS, WHAT ARE THE WEAKNESSES? ONE OF THE PROBLEMS OF THE VACCINE PROGRAM, PROPERLY IT'S A NIGHTMARE. IT GOES ON OWNED ON, CLOSURE. ONE THING I'VE LEARNED WITH MY PROGRAMS, NOTHING THAT PROMOTES THE PROGRAM MORE THAN SPEED, CERTAINTY, AND EFFICIENCY. IT'S NOT A LONG WINDED DISPUTE. AND -- BUT I'M WITH YOU IN SAYING IS THE VACCINE PROBLEM WITH DEFINITELY SOMETHING TO EXAMINE. NOT SO MUCH IN TERMS OF MONEY, BY IN TERMS OF HEALTHCARE SERVICES, MY BE CLOSER TO WHAT JEAN BURNS WAS INTERESTED IN. I THOUGHT BOTH TALKS WERE GREAT. I THINK I CAN FIND THE UNCERTAINTY ABOUT THE ETHICAL BASIS FOR ANY SORT OF COMPENSATION PROGRAM. THAT MIGHT REFLECT THE WORLD, THE LAW AND POLITICAL CONTEXT. I THINK THE PROSPECTS WERE GOOD. I DON'T THINK IT'S A MATTER OF MERCY. THERE ARE TWO IDEAS, PRINCIPLE BASIS FOR COMPENSATION IN THE FORM OF NEEDED HEALTHCARE. ONE WOULD BE GRATITUDE, AND THE OTHER WOULD BE JUSTICE IN A SPECIFIC SENSE OF MAKING A PERSON WHOLE. I THINK OF AN ANIMALGY WITH MILITARY SERVICE. AS IT HAPPENS, WE -- WE SORT OF COMPENSATE VETERANS BY OFFERING THEM HEALTHCARE FOR LIFE. IMAGINE THAT WE DID SOMETHING DIFFERENTLY. IMAGINE THAT WE DIDN'T HAVE A VA, AND WE DIDN'T GUARANTEE HEALTHCARE TO VETERANS WHO WERE INJURED IN THE COURSE OF SERVING THEIR COUNTRY. I THINK MOST PEOPLE WOULD SAY THERE WOULD BE SOMETHING VERY WRONG WITH THAT. AND THAT AS A MATTER OF JUSTICE, AND GRATITUDE, WE SHOULD AT LEAST COMPENSATE THEM IN A FORM OF GIVING THEM HEALTHCARE SERVICES FOR INJURIES SUSTAINED WHILE THEY'RE SERVING THEIR COUNTRY. WE CAN THINK OF PARTICIPANTS AND RFP AS SEARCHING THEIR COUNTRY ALSO, PUTTING THEIR BODIES ON THE LINE. WE CAN HAVE A COMPENSATION THAT CONSISTED IN HEALTHCARE SERVICES THAT WERE NEEDED TO MAKE THEM AS WHOLE AS POSSIBLE. IF YOU CAN'T GIVE BACK LEGS, YOU CAN'T, BUT YOU CAN DO WHAT YOU CAN IN A PRINCIPLED WAY. AND I THINK JUST AS WE WOULD EXPECT AT LEAST THAT MUCH OF ANY DECENT SYSTEM THAT RESPONDED TO THE NEEDS OF VETERANS, WE COULD DO THE SAME FOR THOSE WHO PUT THEIR BODIES OWNED SOMETIMES THEIR PSYCHES ON THE LINE IN SERVING AS HUMAN RESEARCH PARTICIPANTS. SO I THINK ACTUALLY THE PROSPECTS FOR A PRINCIPLE BASIS ARE FAIRLY GOOD. YOU'D STILL HAVE THE PROBLEMS OF DETERMINING EXACTLY WHO IS ELIGIBLE BUT AT LEAST THERE WOULD BE A RATIONALE, THOSE WHO SUSTAINED HARM IN THE COURSE OF SEARCHING AS RESEARCH PARTICIPANTS WOULD BE ENTITLED AT LEAST TO THE HEALTHCARE NEEDED, THE BEST HEALTHCARE AVAILABLE NEEDED TO RESTORE THEM AS MUCH AS POSSIBLE. THAT WOULD BE A FORM OF COMPENSATION THAT I THINK WOULD BE PRETTY MEANINGFUL. I THINK IT WOULD RESPOND TO WHAT JEAN WAS TALKING ABOUT. >> FIRST OF ALL, THE WAY YOU ARTICULATE, YOU OUGHT TO BE THE CHAIRMAN OF THIS COMMITTEE. [LAUGHTER] ALL WELL SAID. I WOULD MAKE TWO CHALLENGING RESPONSES. FOR YOUR CONSIDERATION. INFORMATION GET GRATITUDE. YOU MAY THINK -- FORGET GRATITUDE. YOU MAY THINK IN AN APPROPRIATE CASE, RESEARCH RELATED VICTIM WILL EXPRESS GRATITUDE. GOOD FOR YOU IF YOU CAN GET IT. I'VE NEVER SEEN GRATITUDE EXPRESSED BY ANYONE -- >> PLEX GRATITUDE TOWARD -- OH, PUBLIC GRATITUDE. I SEE. SECONDLY, SECONDLY, BE CAREFUL WHEN YOU SUBSTITUTE MEDICAL CARE FOR A CHECK. MY EXPERIENCE TELLS ME THAT MEDICAL CARE WILL BE, WHAT, TEN TIMES MORE EXPENSIVE THAN A CHECK. AND THERE WILL BE A GREAT DEBATE OVER THE NATURE, THE QUALITY, AND THE QUANTITY OF THAT MEDICAL CARE. I'M NOT DISAGREEING WITH YOU IN THE ABSTRACT. CONCEPTUALLY. I'VE FOUND THAT IN ALL THE PROGRAMS I'VE WORKED ON, THE PHYSICAL INJURED RECEIVING WORKERS COMP OR CERTAIN CARE -- THIS IS ALL FOOD FOR THOUGHT. AND YOU'RE THE CHAIRMAN OF THE COMMITTEE LOOKING INTO THIS. SO I'M SURE YOU'LL SET THE APPROPRIATE AGENDA. [LAUGHTER] >> ALL RIGHT. >> I'M SURE YOU WON'T PROPOSE TO TAKE AWAY THE SAME BENEFITS FROM OUR VETERANS. ALL RIGHT. >> ABSOLUTELY NOT! IF THE VETERANS CAN GET THOSE BENEFITS, WITHOUT WAITING IN LINE FOR 18 MONTHS. >> AS WE HOPE. >> AND CERTAIN PRESUMPTIONS IN FAVOR OF THAT CARE. I'M ALL WITH IT. >> ALL RIGHT. SO IF YOU'RE NOT A VICTIM OF AN APRIL FOOL'S JOKE, MAYBE YOU'LL JOIN US APRIL 1. IN THE MEANTIME WE THANK SCOTT, KIM, JEAN BURNS OUR HEROIC FIRST PATIENT PARTICIPANT PRESENTER AT ETHICS GRAND ROUNDS AND KEN FEINBERG. THANK YOU! [APPLAUSE]