I WOULD LIKE TO START BY
INTRODUCING OUR NEW ALTERNATE
EX-OFFICIO BOARD MEMBERS, WE
HAVE ADMIRAL GEND, WITH THE
UNITED STATES AIRFORCE.
[ APPLAUSE ]
>> AND BEFORE WE START THE
MEETING, I WOULD LIKE TO SADLY
SAY THAT THIS IS DR. LINDBERG'S
LAST AND 91st MEETING OF THE
NLM BOARD OF DIRECTORS OF THE
NLM.
>> [INDISCERNIBLE]
>> [LAUGHTER]
>> I HAVE THE HONOR TO BE THE
26th CHAIR OF THE BOARD AND
SERVE DURING THIS SPECTACULAR
TENURE SO WE APPRECIATE
EVERYTHING.
JOHN WILL RETIRE AT THE END OF
MARCH AND THE NLM AND CENSUS NLM
ARE PLANNING A NUMBER OF
TRIBUTES TO HIM AND MARE
SCHEWILL BE SENDING MORE
INFORMATION TO YOU ABOUT THESE
AS THEY BECOME AVAILABLE.
AND THE BOARD HAS PREPARED A
RESOLUTION WHICH YOU'VE ALL SEEN
TO CONGRATULATE AND THANK JOHN
FOR EVERYTHING HE'S DONE FOR NLM
AND EVERYBODY AND WE ARE GOING
TO FORMALLY APPROVE IT NOW AND
PRESENT IT THIS EVENING AT OUR
DINNER.
SO MAY I HAVE A MOTION TO
APPROVE?
[LAUGHTER]
>> PASS!
>> OKAY.
>> THIS IS VERY SAD BUT HE'S
MOVING ON TO THE NEXT STAGE.
NEXT UP IS THE REPORT FROM THE
OFFICE OF THE SURGEON GENERAL.
RADM SCOTT GIBERSON.
>> GOOD TO BE HERE THIS IS THE
FOURTH TIME I'VE BEEN ABLE TO
PRESENT, OUR NEW SURGEON GENERAL
IS ON TRAVEL, SO I WILL UPDATE
YOU ABOUT THE TRANSITION OF THE
OFFICE OF THE SURGEON GENERAL
AND THEN A BIT ABOUT THE WEST
AFRICAN RESPONSE AND EVERYBODY
WILL HAVE A GOOD UPDATE ON THAT.
AS YOU KNOW WE'VE HAD SELECTED
AND CONFIRMED A 19th SURGEON
GENERAL OF THE UNITED STATES,
DR. MURPHY, HE CAME IN THIS LATE
DECEMBER AND JOINED US EARLY,
RIGHT AFTER THAT, ACTUALLY
BEFORE THE HOLIDAYS AND STARTED
WORK SO IT'S BEEN A DEDICATED
WORKFORCE TO BRING HIM UP TO
SPEED AND MAKE SURE HE'S
COMFORTABLE IN THE NEW POSITION
AS THE SURGEON GENERAL OF THE
UNITED STATES.
HE IS--ON A MORE PERSONAL LEVEL,
VERY GOOD MAN, ASKING A LOT OF
QUESTIONS, HAS COME IN WITH WHAT
WE THINK IS A VERY GOOD APPROACH
TO IT, THE OFFICE OF THE SURGEON
GENERAL KNOWING HE DOESN'T HAVE
THE GOVERNMENT EXPERIENCE
NECESSARILY OR THE UNIFORM
EXPERIENCE, HOWEVER, HE'S
ADAPTING VERY WELL, AND ASKING A
LOT OF QUESTIONS AS I SAID, SO
THE LEADERSHIP THAT'S BEEN THERE
AS CAREER OFFICER, SO IT'S BEEN
A WONDERFUL TRANSITION FOR HIM
AND US AND WE ARE EXCITED ABOUT
THE POSSIBILITYS, LOOKING
FORWARD TO THE FUTURE WITH HIM
AND SUPPORT HIM ANYWAY WE CAN.
SO AS OF NOW IT'S STILL RADM AND
MYSELF THERE, BUT WE'RE VERY
POSITIVE ABOUT THE FUTURE, SO AS
WELL, MOST PEOPLE DON'T KNOW WE
HAVE A NEW ACTING ASSISTANT
SECRETARY FOR HEALTH, DR. HOWARD
KOH, LEFT HIS POSITION AND
JOINED HARVARD FACULTY AND NOW
WE HAVE A ACTING ASSISTANT
SECRETARY, SHE'S DID A LOT OF
RESPONSE IN NEW ORLEANS, SHE IS
A ROCK STAR FOR US, HE IS
TREMENDOUSLY INTELLECTUAL MIND
FOR THE OFFICE OF THE SECRETARY
FOR HEALTH.
HE AS A GOOD APPROACH FOR PUBLIC
HEALTH, GOOD PUBLIC HEALTH
BACKGROUND.
WE'RE FORTUNATE TO HAVE HER AS
WELL.
SHE'S ACTING AND HOPEFULLY SHE
WILL BE CONFIRMED SOME DAY BUT
RIGHT NOW IN THE ACTING POSITION
AND SUPPORTING US AND SURGEON
GENERAL'S BOSS.
WE HAVE TO MAKE SURE THAT'S A
GREAT RELATIONSHIP AND SO FAR,
SO GOOD.
SO WE'RE VERY HAPPY ABOUT THE
DYNAMICS RIGHT NOW AND THE
OFFICE OF THE SURGEON GENERAL
AND THIS IS THE SECRETARY FOR
HEALTH.
THAT'S SOME OF THE TRANSITION
WE'RE GOING THROUGH.
>> I CAN TELL YOU THAT THE
SURGEON GENERAL HAS UNIQUE
APPROACHES TO THINGS.
I'VE SPENT TIME WITH HIM, WE
TRAVELED THE CDC, LEADERSHIP OF
OTHER AGENCIES AND DEPARTMENT OF
HEALTH AND HUMAN SERVICES AND
WE'RE HEADED TO THE DEPARTMENT
OF DEFENSE AND TALK TO
DR. WOODSON AND OTHER FOLKS IN
THE DEPARTMENT OF DEFENSE, OTHER
SURGEON'S GENERAL, HE WILL BE
ABLE TO MEET THEM, GREET THEM
AND TALK ABOUT HIS PHILOSOPHIES
MOVING FORWARD.
HE WANTS TO MODERNIZE OUR
APPROACH TO PUBLIC HEALTH.
WE HAVEN'T GOATEN DETAILTHAT BUT
HE CONTINUES TO SPREAD THAT
MESSAGE ABOUT MODERNIZING THE
APPROACH OF PUBLIC HEALTH.
REACHING COMMUNITIES FOR DEEPER
PENETRATION INTO THESE
COMMUNITIES.
UTILIZING THE MEDIA NETWORK THAT
WE HAVE AND THAT HE UNDERSTANDS
VERY WELL, UTILIZING AND
REACHING ALL COMMUNITIES OF ALL
CULTURAL BACKGROUNDS, SO I THINK
THAT'S STRONG MOVING FORWARD, HE
WANTS TO TURN INFORMATION INTO
ACTION WHICH IS ANOTHER APPROACH
TO TAKE IT ONE STEP FURTHER.
WE OFFICE OF THE SURGEON GENERAL
PROVIDE INFORMATION TO
COMMUNITIES AND IT'S ALWAYS MORE
COMPLEX, THE DETAILS, THE
DEVIL'S IN THE DETAILS, LET ME
MENTION THAT EARLIER ABOUT HOW
TO TRANSLATE THAT INFORMATION
INTO ACTION.
SO I THINK HE WILL WORK TOWARDS
THOSE GOALS.
HE'S A BIG SUPPORTER OF THE
NATIONAL CONVENTION STRATEGY SO
HE WILL BE WORKING WITH THAT OR
WITHIN THAT PARADIGM AND I THINK
THAT'S A POSITIVE APPROACH.
HE WAS A MEMBER OF THE NATIONAL
PREVENTION COUNCIL SO HE'S
FAMILIAR WITH THE STRATEGY SO
WELL VERSED VISIT AND I THINK HE
HAS A GOOD WAVE FORWARD.
A COUPLE INITIATIVES AT THE
MOMENT.
WE'RE LOOKING AT THE
PRESCRIPTION DRUG ABUSE CALL TO
ACTION, WE DON'T KNOW THE EXACT
TITLE OF IT YET BUT IT'S
SURROUNDING PRESCRIPTION DRUG
ABUSE OR ILLICIT DRUG ABUSE AND
BEHAVIORIAL HEALTH SURRENDERING
THAT.
WE EXPECT THIS TO BE OUT IN THE
SPRING FOR THE WALKING CALL TO
ACTION, WE'RE NOT SURE ABOUT THE
TRANSITION AND NEW STAFFING, WE
WILL SEE THAT'S PENDING RIGHT
NOW.
WE DON'T HAVE AN EXACT DATE FOR
THAT RELEASE.
OBVIOUSLY WE'VE HAD AND THAT
SORT OF SUMS UP SOME OF THE
ACTIONS AROUND THE OFFICE OF THE
SURGEON GENERAL AND OF COURSE
FOLLOWING MURPHY'S WAY FORWARD,
WHATEVER HE MAY DESIRE TO MOVE
FORWARD IN HIS TERM NOW.
HE UNDERSTANDS THE TERM OF THE
SURGEON GENERAL'S FOUR YEARS,
AND HE'S GOING TO TRY TO DO A
LOT OF THINGS IN A SHORT PERIOD
OF TIME AND WE'RE SUPPORTIVE OF
THAT.
SO, ONE OF OUR BIGGEST MISSIONS
IN THE LAST--PROBABLY EVER
HISTORICALLY IN THE PUBLIC
HEALTH SERVICE, WE'VE BEEN
ENVELOPED AND RESPONSE TO
INFECTIOUS DISEASE ACROSS OUR
HISTORY, NOTHING PROBABLY AS
VISIBLE OR UNIQUE AS RESPONSE TO
EBOLA IN WEST AFRICA, AND I HAD
THE PRIVILEGE AND I TRULY MEAN A
PRIVILEGE, TO GO THERE, I
CONSIDER IT MY JOB AND DUTY BUT
NOT EVERYBODY GETS TO GO AND
THERE'S A LOT OF PEOPLE THAT
WOULD LIKE TO GO AND HELP WEST
AFRICK A.
I HAD THE PRIVILEGE TO GO IN A
COUPLE MONTHS IN THE VERY
BEGINNING WHEN THEY GAVE ME A
PATCH OF DIRT AND THEY SAID YOU
HAVE TO WORK WITH ALL THE
PARTNERS AND CREATE A HOSPITAL
FOR HEALTHCARE WORKERS INFECT
WIDE EBOLA AND THAT WAS THE
CHARGE FROM THE U.S. GOVERNMENT.
WE KNEW THAT AT THE TIME WE ARE
GOING TO BE AND STILL ARE THE
ONLY ASSET OF ALL OF THE U.S.
GOVERNMENT THAT'S ACTUALLY
TREATING PATIENTS IN LIBERIA, OR
ALL OF WEST AFRICK ASO IT WAS AN
INCREDIBLE MISSION TO GIVE YOU
THE MAGNITUDE OF IT.
THE U.S. PUBLIC COMMISSION CORE
IS IN NINE U.S. DEPARTMENTS,
MOST PEOPLE DON'T KNOW WE'RE IN
THAT U.S. DEPARTMENTS AND 20
AGENCIES.
OF THOSE WE'VE TAKEN ROVE FROM
OF SEVEN OF THE NINE DEPARTMENT
AND 15 OF THE 20 AGENCIES TO
DEPLOY.
WE DEPLOY OVER 220 FOLKS
DIRECTLY TO THE MMU, WHICH IS
THE MONROVIA MEDICAL UNIT WHICH
IS OUR MAIN MISSION.
WE HAVE OTHER MISSIONS IN WEST
AFRICA.
THEY'RE NOT DIRECT PATIENT CARE
AT THE MMU.
AND WE'VE HAD CLOSE TO A HUNDRED
OR SO DEPLOYED OVER THAT. CDC
HAS HAD OVER 200 OFFICERS THAT
DEPLOYED.
AND IT'S BEEN A HYG
COLLABORATION, WHILE WE'RE OVER
THERE, OUR MAIN PARTNERS ARE THE
CDC AND DEPARTMENT OF DEFENSE
AND WE WORK CLOSELY WITH ARMED
FORCES TO STAFF--THE BUILDING
STRUCTURE, STAFF THE STRUCTURE
AND WORK FOR ALL THE PUBLIC
HEALTH SEQUELING COUNTRY OF THE
OUTBREAK SO, SO FROM THE NIA
PERSPECTIVE WE HAVE A UNIQUE
SITUATION NOW WHERE WE'RE GOING
TO BE INVOLVED IN VACCINE TRIALS
AND MEDICAL COUNTERMEASURES
WHICH INCLUDES THE MAP TRIAL,
AND WORKING WITH YOUR VERY OWN
CLIFF LANE AT NIH.
GREAT MAN AND WE'VE COORDINATED
WITH THEM SO THAT THE MMU IS A
FACILITY SITE FOR ONE OF THE
ARMS OF THE TRIAL FOR Z-MAT,
WHILE OPERATIONAL DETAILS YET TO
BE UNFOLDING BUT IT IS GOING TO
HAPPEN IN FEBRUARY AS FAR AS WE
KNOW.
EARLY FEBRUARY BUT HOPEFULLY AND
THAT WILL PROBABLY INCREASE OUR
CENSUS BY JUST A COUPLE OF
PATIENTS AND NOT EXPECT TOO MUCH
OF OUR WORK OR CENSUS, OBVIOUSLY
THE EPIDEMIOLOGY IN THE COUNTRY
IS GOING DOWN FAIRLY STEADY
ILLEGALSY, HOWEVER IN FEBRUARY,
THERE'S NEW DYNAMICS COMING AND
WE HAVE THE OPENING OF HOSPITALS
WHICH WILL INCREASE POTENTIAL
FOR EXPOSURE, WE HAVE INCREASES
IN MIGRATION AND WE ALSO HAVE
THE OPENING OF SCHOOLS.
SO I HAVE THE POTENTIAL FOR
CLUSTERS AND MORE OUTBREAKS AND
WE'RE PREPARE FORWARD THAT AND
IT WOULD BE MORE EPISODIC THAN
IN TRENDS.
WE EXPECT TO WORK TOWARDS AN
EXIT STRATEGY APRIL OR MAY TIME
FRAME.
THAT'S WHERE WE'RE HEADED RIGHT
NOW.
OUR HOSPITAL HAS SEEN 36
HEALTHCARE WORKERS AND ADMITTED
HEALTHCARE WORKERS AND VERY
INTERNATIONAL FLAVOR TO THE
PATIENT POPULATION, POST OF THEM
HAVE BEEN LIBERIAN NATIONALS
WHICH WAS OUR GOAL ORIGINALLY
BUT CERTAINLY WE BOOSTED
INTERNATIONAL CONFIDENCE IN WEST
AFRICA SO WE'RE PLEASED AND
PROUD TO BE A PART OF THAT.
SO RECENTLY WE HAD THE RETIN OF
OUR SECOND TEAM--RETURN OF OUR
SECOND TEAM.
70 MEMBERS OF THE PUBLIC HEALTH
SERVICE CORE AFTER SPENDING 50
DAYS IN MMU, 24/SEVEN, THEY
RETURNED HERE TO WASHINGTON D.
C. TO A NICE WELCOME AND THEY'LL
SPEND 21 DAYS AND NOT ALL OF
THEM WILL SPEND 21 DAYS, BUT
SOME OF THEM WILL SPEND 21 DAYS
AND SOME OF THEM HAD NO CONTACT
WITH PATIENTS FALLING TO
SCIENCE, WHAT WE SEND IN THE
BACK TO REGULAR, REGULAR WORK
PENDING THOSE SYMPTOMS, SO, THE
REPORT AS OF THIS MORNING,
EVERYBODY DATES, ASYMPTOMATIC
AND HEALTHY&$ LOOKING FORWARD
TO GETTING BACK TO THEIR
FAMILIES.
IN A NUT SHELL, I WILL TAKE
QUESTION FIST POSSIBLE, BECAUSE
I KNOW THERE'S A LOT OF
QUESTIONS ABOUT THE EBOLA
RESPONSE AND I'LL BE HAPPY TO
ANSWER THEM BUT ARE OTHER THAN
THAT, THAT CONCLUDES THE OSG
BRIEFING.
NEXCELLENT.
>> I WAS 10 MINUTES SHORT.
[LAUGHTER]
>> I JUST GOT BACK FROM AFRICK
AAND THEY ASKED ME IF I HAD
EBOLA AND I'M GOING TO WAIT--NO,
I DON'T THINK SO.
[LAUGHTER]
>> WERE YOU IN THE UNIT AND DID
THEY, YOU KNOW IN THE ACTUAL
CARE UNIT, DID THEY USE THE
POWER RESPERRATORS NOW OR
JUST--RISK ASSESSMENTS PIRATORS
NOW OR JUST MASKS?
>> WE HAVE THEM STAY NOTHING THE
HOT ZONE SO THEY'RE USING THE
RESPIRATORS AND THEN THE OTHERS
OUTSIDE OF THAT ARE USING THE
MASK.
>> SO MEDICAL INFORMATICS SO THE
HEAD OF THE VA, CIO OR CMO, SO
THAT'S NOT--[INDISCERNIBLE].
>> SO RIGHT NOW Y'ALL KNOW THE
ADMIRAL, ONCE THE SURGEON
GENERAL CAME IN, WE BROUGHT
ADMIRAL MURPHY UP TO SPEED AND
THEN THE ADMIRAL MISCHNIEAK WENT
OVER THERE IN LIBERIA IN COMMAND
AND HE JOINED PUBLIC HEALTH
HANDS-ON ACTION AND I KNOW
THAT--YOU ALL KNOW THAT'S WHAT
HE WOULD WANT TO DO, ADMIRAL
MURPHY APPROVED IT AND I'M
HOLDING DOWN THE FORT HERE AND I
WAS JOKING WITH THE GENERAL HERE
THAT NOW HE'S UNDER MY COMMAND,
AND EVEN THOUGH HE'S A TWO
STAR,--[LAUGHTER]
ROBBER I'M LOOKING FOR THAT
REPORT SIR.
[LAUGHTER]
I RARELY GET THAT OPPORTUNITY SO
YES I WILL EMBRACE IT.
WHEN HE GETS BACK I'LL PROBABLY
GET FIRED.
[LAUGHTER]
IF I'M NOT AT THE NEXT MEETING
YOU'LL KNOW WHY.
ANYWAY I'M HEADED BACK OUT AND
ONCE WE DEFINE THE EXIT STRATEGY
I'LL BE CLOSING OUT THE EFFORT
SO I WAS ABLE TO HAVE THE
PRIVILEGE TO START ON THE
OPPORTUNITY TO CLOSE IT OUT WITH
GOVERNMENT OF LIAISON BERNEA
DEET WAAND THE ADMINISTER HEALTH
AND I'M VERY PROUD OF THAT.
>> WHAT DO YOU SEE AS THE FUTURE
OF EBOLA?
>> THAT'S DISCUSSED A LOT WITH
CDC, IT MAY BECOME ENDEMIC IN
THAT AREA AND WE SEE SMALL
CLUSTERS MIGRATION, EPISODIC
EPIDEMIOLOGY, SO THERE'S REALLY
NO PREDICTION, WE DO HAVE A LOT
OF SECOND ORDER EFFECTS OF THE
OUTBREAK, THOUGH, WE HAVE A A
DELAPIDATED AREA, SO WE WILL
HAVE TO WORK ON REBUILDING THEIR
PUBLIC HEALTH INFRASTRUCTURE,
THEIR HOSPITAL SYSTEM,
HEALTHCARE WORKFORCE SO WE'LL
HAVE SMALLER MISSIONS THAT WILL
HELP TRAIN FOLKS, WORK WITH CDC
ON PERMANENT OFFICE IN LIAISON
IN LIBERIA,
SO SMALL PIECES LIKE THAT
CONTRIBUTE TO THE EFFORT.
>> I NOTICED YOU MENTIONED
VACCINATION FOR MEASLES OR
MUMPS.
>> THAT'S PART OF THAT PUBLIC
HEALTH INFRASTRUCTURE.
>> [INDISCERNIBLE]
>> --IN THE UNITED STATES AS
WELL AS LIBERIA.
>> DIDN'T WANT TO GET INTO THAT
ONE BUT DEFINITELY PART OF THE
PUBLIC HEALTH VACCINATION, AND
THERE'S A LOT OF NEED, EACH A
PRENATAL CARE, THERA'S SO MANY
NEEDS NOW AND MOST PEOPLE COME
IN FOR MALARIA.
>> [INDISCERNIBLE].
--VACCINATION TREATMENT?
>> I THINK THE VACCINATION TRIAL
AND 9000 EACH.
AND DR. LANE IS THE EXPERT ON
THAT AND I WOULD ASK HIM THAT
QUESTION BUT I THINK HE'S
COMFORTABLE IN THE SITUATION
THEY HAVE RIGHT NOW WITH THE
VACCINE TRIAL.
I'M NOT TOO SURE ABOUT THE
TREATMENT, THE THERAPEUTIC TRIAL
AND THAT'S DIFFICULT BECAUSE YOU
NEED TO BE POSITIVE PATIENT, FOR
DEPUTY DISEASE IS NOT THERE
RIGHT NOW IN LIBERIA AND NOW IT
STILL IS IN GUINEA AND SIERRA LE
OWN AND WE'LL SEE HOW IT UNFOLDS
BUT HE'S WORKING ON STRATEGIES
TO MAKE SURE THE TRIAL WORKS
SUCCESSFULLY.
NOW I KNOW HE EXPECTED TO NOT
TAKE A LOT IN TO COMPLETE THE
TRIAL.
SO 40 PATIENTS I THINK HE NEEDS
TOTAL, SOMETHING LIKE THAT SO I
THINK IT'S A SMALL AMOUNT THAT'S
NEEDED FOR THAT TRIAL.
I DON'T HAVE ALL THE DETAILS BUT
I'M SURE
HE--[INDISCERNIBLE]--GOING ON.
>> OTHER QUESTIONS?
>> WELL WE HAVE A LONG
DISCUSSION COMING UP LATER IN
THE MORNING SO I WOULDN'T MIND
SAVE THANKSGIVING TIME AND
PROCEEDING IF THAT'S ALL RIGHT.
SO THANK YOU VERY MUCH.
>> [ APPLAUSE ]
>> OKAY, SO THE NEXT ITEM IS
HAVE A VOTE AND APPROVAL OF THE
MINUTES OF THE LAST BOARD
MEETING.
DO I HAVE A--
>> SECOND.
>> SECOND.
>> THANK YOU VERY MUCH.
>> AND OTHER TECHNICAL ITEM IS
THE PROPOSED DATES FOR THE
WINTER MEETINGS IS NEXT YEAR AT
MORE OR LESS SAME TIME,
FEBRUARY 9-10.
ARE THERE ANY COMMENTS?
OKAY, SO NO OBVIOUS CONFLICTS,
LET'S MAKE SURE THAT THAT IS
DONE ON THE CALENDAR.
SO 10 MINUTES EARLY, DON WOULD
YOU LIKE TO GIVE YOUR REPORT.
>> SO I HAVE TO WARN YOU THAT WE
ENDED UP WITH A LOT OF ITEMS WE
NEED TO EXPLAIN AWAY OR BRING TO
YOUR ATTENTION SO I'LL BE MABEL
A LITTLE BIT MORE SUPERFICIAL
THAN USUAL BUT I'LL INVITE TO
YOU ASK QUESTIONS AT ANY POINT
AND I'LL EITHER INVENT AN ANSWER
OR I'LL FIND SOMEONE WHO KNOWS
MORE ABOUT IT.
DON'T HESITATE IF YOU WANT MORE
INFORMATION ON ANY OF THESE
MATTERS.
NOW ITEM A IS USUALLY BUDGET AND
THAT COULD TAKE SEVERAL WEEKS
BUT WE WON'T SPEND THAT MUCH
TIME.
THE STRANGE SITUATION SYSTEM
THAT WE ACTUALLY HAVE A 2015
BUDGET.
OMB HAS NOT DONE SOMETHING
CALLED APPORTIONING, WHICH SAYS
HOW MUCH EACH ELEMENT OF NIH
GETS SO THEREFORE WE MAY NOT
PRESENT IT TO YOU,OT OTHER HAND
WE'RE UP TO OUR EYEBALLS IN 2016
BUDGET AND THAT OF COURSE HAS
BEEN PRESENTED BY THE PRESIDENT
AND IS AVAILABLE TO YOU IN GORY
DETAIL.
SO NO PROBLEM THERE.
NOW, OUR BUDGET ITSELF AT THE
MOMENT AS THE BOOK LAYS OUT FOR
YOU IS 228 MILLION DOLLARS PLUS
70 MILLION IN VARIOUS OTHER
FORMS INCLUDING CARRY OVER AND
APPROPRIATIONS FROM OTHER
AGENCIES.
ONE OF OUR BIGGEST PROBLEMS HAS
BEEN IN THE PAST, IS NO WAY
EXCEPT JUST TO EXPLAIN THIS IS
THAT THE WORK OF NCBI CONTINUES
TO INCREASE AS PEOPLE KEEP
SENDING SEQUENCES ASK VARIOUS
BITS AND PARTS OF THE GENOMES
AND WHAT NOT.
AND SO, THAT TAKES MORE MONEY, I
MEAN I HAVE TO REMIND YOU THAT
WE'VE GONE FROM THREE PEOPLE AT
NCBI TO 300.
ALL ON NLM DOLLARS AND WE FOUND
THE MONEY TO SUPPORT THAT
INCREASE AND GIVEN IT THE TOP
PRIORITY FOR QUITE A FEW YEARS
SO IT ISN'T THAT IT'S BEING
NEGLECTED BUT BEYOND THAT POINT,
IT'S BEYOND THE POINT AT WHICH
IT'S CLEARLY ESSENTIAL TO MANY,
MANY PARTS OF SCIENTIFIC
FUNCTION AT NIH AND BEYOND, IT
JUST SIMPLY HAS TO HAVE BROAD
INSTITUTIONAL SUPPORT AND EVERY
TIME THAT'S BECOME ESSENTIAL,
EVERY ELEMENT OF NIH INCLUDING
THE CURRENT DIRECTOR, WHEN HE
WAS DIRECTOR OF GENOME HAS
SUPPORTED IT VERY STAUNCHLY SO
TO SPEAK, WELL THAT'S A PROCESS
CALLED PASSING THE HAT AND IT'S
OBNOXIOUS, INEFFICIENT AND TAKES
TIME AND EFFORT AND ALMOST
EVERYBODY IN THE COMMITTEE WHEN
I'VE EVER BEEN PRESSED HAS BEEN
CERTAINLY ENCOURAGED BY FAUCI
AND COLLINS HAS SAID LOOK, GIVE
THEM THE MONEY, PUT IT IN THE
BASELINE AND FORGET ALL THESE
MEETINGS AND TIN-CUPPING.
SO NIH SUPPORTED THAT VIEW FOR
THREE YEARS, I THINK,
MAYBE--MAYBE EVEN FOUR?
YEAH.
SO THE RECOMMENDATION AND
REQUEST OF A DIRECTOR OF NIH, TO
THE CONGRESS TO VARIOUS FORMS OF
THE CONGRESS HAS BEEN TO JUST
APPROPRIATE THE MONEY AND PUT IT
IN NLM BASE AND WE'LL TAKE CARE
OF THEM AND WE'LL MEET AGAIN SO
THAT HAS BEEN THE POSITION BUT
IT'S NOT EVER HAPPENED.
I MEAN, IT JUST HASN'T HAPPENED.
THEY'VE MADE THE RECOMMENDATION
AND MADE THE REQUEST, CONGRESS
IS NOT ACTING.
>> [INDISCERNIBLE]--LET YOU
KNOW, THE CURRENT PRESIDENT'S
BUDGET WITH WHAT THEY
RECOMMENDED FOR 2016 IS A NEW
PAPER IT HAPPENED THIS WEEK.
>> YEAH, 2016 WE CAN TALK ABOUT.
NOW THERE, IN THEORY, IS SORT OF
AN EXTRA BILLION DOLLARS IN THE
NIH BUDGET SO THE MANAGER'S OF
NIH HAVE TAKEN THE OCCASION TO
USE THAT AS IF IT WERE SORT OF
NEW MONEY GIVEN IT TO NCBI AS
OPPOSE TO SUBTRACTING IT FROM 17
DIFFERENT INSTITUTES.
SO MAYBE THIS WILL ONE STICK, WE
DON'T KNOW YET.
ANYWAY, SO SOME OF THE NUMBERS
MAY CONFUSE YOU JUST MOMENTARILY
AND THAT'S THE BASIS FOR THE
CONFUSION AND IT'S GOOD, I MEAN,
THEY'RE TRYING HAD OF-THE
ADMINISTRATION CURRENTLY IS
TRYING TO MAKE IT SENSIBLE,
WE'LL SEE HOW THAT WORKS.
NOW INTERNALLY, THERE'S ALSO
BUDGET ISSUES AND THEY COULD BE
DRIBBED IN ENOUGH DETAIL FOR
YOU--DESCRIBED IN ENOUGH DETAIL
FOR YOU IMMENSELY, THEY HAVEN'T
BEEN JUGGLING THE BOOKS BECAUSE
IN THE ENDING THE YEAR, ONE OF
OUR MANY CONTRACTORS WHICH IS A
DUTCH OUTFIT BUYS JOURNALS FOR
US FROM 3300 BNCHT PUBLISHERS
AND 36 DIFFERENT COUNTRIES AND
IT'S GOOD TO WORK THAT OUT, BUT
THEY WENT BANKRUPT IN THE MIDDLE
OF EVERYTHING, IN THE MIDDLE OF
OUR CONTRACTS AND ALL THIS
STUFF.
SO THE STAFF IS BOTH L. L. AND
THE ACCOUNTING PEOPLE HAVE
PERFORMED NOBLY AND FILMILY AND
WE THINK THE BOOKS WILL BE ON
THE SHELF AND THE MONEY WILL BE
AN ACCOUNTING BOOK, BUT A LOT OF
WORK TO MAKE THAT HAPPEN.
I GUESS WE DON'T HAVE A NEW
CONTRACTOR DO WE?
>> WE EXPECT, I
THINK--[INDISCERNIBLE]
>> [LAUGHTER]
>> SO ALL OF THAT HAS TO GO
THROUGH IN PROPER LEGAL FASHION.
SO THAT WAS A LITTLE BIT OF A
BLIP IF YOU'LL IMAGINE IT.
NOW I THINK THAT'S AN OVERALL
VIEW OF THE BUDGET, BUT WE CAN
GO INTO MORE DETAIL IF ANY OF
YOU WISH.
SO, THE PRESIDENT'S REQUEST AND
SUMMARY FOR 2016 IS 394 MILLION
DOLLARS WHICH IS A BIT OF AN
INCREASE OVER THE LAST.
ALSO EXTRA MONEY IS ASSIGNED TO
CLINICAL TRIALS.GOV AND AS WE'LL
DESCRIBE LETTER WE'RE
TRANSFERRING THE OPERATION FROM
LISTER HILL TO NCBI FOR A NUMBER
OF GOOD REASONS BUT IT'S BECOME
REALLY OPERATIONAL.
IT'S NOT A RESEARCH POSSIBILITY
ANYMORE, IT'S A REALLY
OPERATIONAL THING THAT EVERYONE
COUNTS ON.
SO SUCH THING VS MIGRATED IN THE
PAST.
--SUCH THINGS HAVE MIGRATED IN
THE PAST.
NOW PERSONNEL IS USUALLY GOOD
NEWS, NEVER LIKE GOOD PEOPLE
LEAVING BUT LIKE GOOD PEOPLE
COMING SO I WILL TALK ABOUT THE
OFFICE OF DIRECTOR BY OFFERING
BETSY THE OPPORTUNITY TO INVITE
AND TO WELCOME THE FIRST TWO
PEOPLE.
>> THERE'S DORA.
>> DORA DIGBY HAS BEEN WITH NLM
NEAR A NUMBER OF YEARS, I THINK
1999 AND SHE WORK INDEED A
VARIETY OF CAPACITIES IN LIBRARY
OPERATIONS DIVISION AND WAS
RECEIPTLY CAPTURED BY THE OFFICE
OF THE DIRECTOR AND OFFICE OF
ADMINISTRATION TO THE BRC AND
ADMINISTRATIVE OFFICER, SHE'S
BEEN A HUGE ASSET IN MANY THINGS
INCLUDING HUMAN RESOURCES AND
PERSONAL RELATED MATTERS AND
WE'RE DELIGHTED TO HAVE HER IN
OUR OFFICE AND I THINK THAT I
WILL ALSO INTRODUCE SALARY--WE
USED TO KNOW HER AS
[INDISCERNIBLE] WHIPPLE WHO CAME
BACK TO NLM.
SHE WAS A STELLAR PERFORMER IN
OUR CONTRACT OFFICERS AND LEFT
US TO GO TO GREATER THINGS AND
THE NUCLEAR REG RATTERY
COMMISSION AND SO FORTH AND WE
WERE ABSOLUTELY DELIGHTED AS
WHEN WE GOT HER BACK AS THE
DEPUTY DIRECTOR OF OUR
COOPERATIVE ACQUISITION CENTERS.
IS THAT WHAT IT'S CALLED?
OUR CONTRACTING OFFICE IS ONE OF
SEVERAL ACROSS NIH WHICH
PROVIDES CONTRACTING SERVICES
NOT ONLY FOR THE NATION ALTHOUGH
LIBRARY OF MEDICINE BUT FOR
OTHER PARTS OF NIH AS WELL.
NOT EVERY INSTITUTE HAS A
CONTRACTING OFFICE BECAUSE THEY
DECIDED IT WAS MORE EFFICIENT
WHICH IT IS TO PROVIDE SERVICES
MORE ESSENTIALLY, THIS IS
SOMETHING THAT NLM HAS A LONG
HISTORY OF DOING.
I THINK PERHAPS GOING BACK TO
THE EARLY DAYS, WHEN WE USED TO
DO THE COMMERCIAL
TELECOMMUNICATIONS CONTRACTS FOR
NOT ONLY JUST ALL OF NIH, BUT
THE DEPARTMENT AND OTHER
AGENCIES AS WELL.
SO WE'RE REALLY GLAD TO HAVE
VALLARY BACK AND SHE WAS A GREAT
ASSET BEFORE AND IS AGAIN.
>> OKAY.
>> ARE YOU GOING TO INTRODUCE
OUR PERSON?
>> MR. THOR SIGFREESEN, HE COMES
FROM N. I. S. T. AND WE'RE GLAD
HE IS HERE.
AND ONE OF THE FIRST CHALLENGES
HE'S AGREE TO UNDERTAKE IS THE
WIND TUNNEL EFFECT BETWEEN THE
TWO BUILDS.
WE EITHER HAVE TO STOP IT OR
SELL IT.
[LAUGHTER]
BUT HE'S FROM ICE LAND SO HE'S
NOT AFRAID OF COLD AND WIND AND
BLOWING BUT WE WANT IT OUTSIDE
NOT INSIDE.
SO WE'RE VERY, VERY GLAD YOU'RE
HERE AND YOU'RE VERY WELCOME.
THANK YOU.
[ APPLAUSE ]
NOW JOYCE WILL TELL US ABOUTLET
NATIONAL LIBRARY MEDICINE ITEMS.
>> I WILL.
[LAUGHTER]
>> FIRST SESSION HAD A NEW
SECTION, LIBRARY TECHNOLOGY
SERVICES SECTION IN OUR
TECHNICAL SERVICES DIVISION, SHE
CAME TO US FROM THE UNIVERSITY
OF MARYLAND, UNIVERSITY COLLEGE
HERE IN TOWN AND I THINK ONE OF
THE MOST IMPRESSIVE THINGS SHE
DID AT UMBC WAS TO CHAIR THE
NEXT GENERATION INTEGRATIVE
LIBRARY SYSTEM GROUP OF ALL 16
LIBRARYS, SO THOSE OF YOU WHO
HAVE CHAIRED GROUPS KNOW WHAT A
CHALLENGE THAT CAN BE, SHE AS A
LOT OF EXPERIENCE IN THE AREAS
THAT APPLY TO HER AREA, HER
EDUCATION IS B. S. IN COMPUTER
SCIENCE AND MATH AND AS WELL AS
M. S. AND SCIENCE, AND SHE HELD
FROM NEW ENGLAND, HOPING HER
FAMILY CAN BE DUG OUT SOON.
BUT SHE'S HERE WITH US
[INDISCERNIBLE].
[ APPLAUSE ]
>> SO [INDISCERNIBLE] IS AN
ACTION OVER LISTED THERE IN L.
>> WE'RE ALSO VERY HAPPY BECAUSE
WE HAVE A LOT OF PROBLEMS IN THE
BUILDING WITH THE MOST
MYSTERIOUS IS THE LEAKS WE
RECEIVE FROM THE ROOF THAT
[INDISCERNIBLE].
[LAUGHTER]
>> THIS IS A STUDY OF GRAVITY?
>> [LAUGHTER]
>> SO [INDISCERNIBLE] IN
NOVEMBER [INDISCERNIBLE]
PHYSICIAN [INDISCERNIBLE] SO
PARIS, FRANCE [INDISCERNIBLE]
RECEIVING SCHOOL OF MEDICINE AND
MEDICINE OF INFORMATICS
[INDISCERNIBLE] ENGINEERING
[INDISCERNIBLE] STANDARD
TERMINOLOGY [INDISCERNIBLE].
HE CAME HERE AND SAID THERE WAS
NO [INDISCERNIBLE].
[LAUGHTER]
OUR NEXT FELLOW IS
[INDISCERNIBLE] R. N.-Ph.D.
AND SHE ARRIVED HERE
[INDISCERNIBLE] SHE AS A DOCTORS
DEGREE FROM UNIVERSITY OF
MARYLAND, SCHOOL OF NURSING
[INDISCERNIBLE] HEALTH OUTCOME
LOCATIONS FOR PERSONAL HEALTH
RECORDS AND [INDISCERNIBLE]
HEALTH DATABASE AND QUALITY OF
CARE, HURRENT IDENTIFY AND
[INDISCERNIBLE] DUAL TECHNOLOGY
AND DEVELOPING A [INDISCERNIBLE]
NURSING DEPARTMENT AT THE
[INDISCERNIBLE], SHE'S GOT A
STRONG COLLABORATOR OVER THERE,
SO MAKERS OF [INDISCERNIBLE] A
LOT OF CROSS [INDISCERNIBLE] SO
BRIAN WORKED WITH--BRIAN CAME
FOR A ONE MONTH MEDICAL SCHOOL
ROTATION IN OCTOBER AND HE
GRADUATED IN DECEMBER AND QUEY
GAVE HIM ENOUGH
KNOWLEDGE--[LAUGHTER]
--BECOME A FELLOW AND HE
RECEIVED HIS MASTER'S DEGREE IN
BIOINFORMATICS [INDISCERNIBLE]
AND HERE IN WASHINGTON, AND
CLINICAL PERIOD WITH US AND
MENTIONED THAT ALREADY AND HE
GOT HIS MEDICAL DEGREE IN
DECEMBER WITH THE UNIVERSITY OF
ARIZONA AND COLLEGE OF MEDICINE,
[INDISCERNIBLE] STANDARD AND A
LOT OF TIMES HEALTH RECORDS AND
CDE, ACTUALLY [INDISCERNIBLE],
[INDISCERNIBLE].
[ APPLAUSE ]
>> THANK YOU SO TAB C IS
DEDICATED TO CLINICAL TRIALS,
BUT JUST TO BRING IN YOUR
ATTENTION THAT THIS BRINGS TO
FORWARD THIS NOTICE OF PROPOSED
RULE MAKING, IT SOUNDS LIKE
INFINITELY BUREAUCRATIC AND IT
REALLY IS, BUT I GUESS WE HAVE
TO BE GLAD THAT THERE'S A VERY
STRONG SORT OF LEGISLATIVE
PROCEDURE ABOUT MAKING RULES,
FEDERAL AGENCIES MAKING RULES
AND THE BOTTOM LINE IS THAT YOU
DON'T DO IT QUICKLY OR CASUALLY
AND YOU CERTAINLY DON'T DO IT
WITHOUT INFINITE TRANSPARENCY,
SO, NIH'S IS GOING TO THIS VERY
LENGTHY PROCESS.
INTERACTING WITH FDA AMAZINGLY
SMOOTHLY.
REALLY AND THE REST OF THE
DEPARTMENT AMAZINGLY GRADUALLY,
BUT THE NETRESULT IS THAT THE
RECOMMENDATIONS OF THE GROUP
HERE FOR VARIOUS PARTS OF THE
CLINICAL TRIALS.GOV LEGISLATION
THAT REQUIRED COMMENT HAVE BEEN
ADAPTED, ADOPTED BY JUST ABOUT
EVERYBODY INCLUDING NIH, AND
NIH'S IS AS I WOULD SAY GO
BEYOND US AND ENTHUSIASM, HEADED
I WOULD SAY BY HAROLD VARMIS AND
NCI, WHO WAS COMPLETELY SHOCKED
TO DISCOVER THAT HALF OF THE NCI
FUNDED CLINICAL TRIALS WAS NEVER
PUBLISHED.
AND HE WAS AS FUNDAMENTALLY
APPALLED AND DISAPPOINTED AND
ESSENTIALLY--HE ESSENTIALLY SAID
THIS CAN'T GO ON.
THIS IS WRONG AND OVER THE
COURSE OF A YEAR HAS REALLY
ALTERED THE INTERNAL MANAGEMENT
OF NCI, HOWEVER BEING AN OCEAN
LINER LIKE TO PREVENT IT AND
ALSO TO GO BEYOND WHATEVER THE
LAW REQUIRES IN SAYING, LIKE ALL
OF THE TRIALS ARE GOING TO GET
HANDLED PROPERLY.
AND NIH'S DECIDED THAT THAT'S A
GOOD POLICY TO FOLLOW SO THERE
ARE REALLY TWO THINGS ON THIS
LEGAL THING AND THEN THERE ARE
RECOMMENDATIONS OF NIH WHICH
ARE--A HUNDRED PERCENT
COMPATIBLE BUT BOTH OF THESE
WILL BRING A BIG CHANGE AND A
LOT OF WORK TO NOW IT TURNS OUT
NCBI BUT HELPING PEOPLE TO
FOLLOW THE LAW, REGISTERS IS NOT
SO DIFFICULT.
PUTTING IN RESULTS IS VERY
DIFFICULT.
YOU CAN HIRE PEOPLE TO REGISTER
STUFF.
YOU CAN'T HIRE PEOPLE TO
UNDERSTAND THE NATURE OF THE
TRIAL.
SO THAT'S TAKEN A LONG TIME.
AND BETSY HAS SPENT AN AMAZING
AMOUNT OF TIME ON IT, JERRY AS
WELL.
>> FILLING US IN MORE ABOUT THIS
AFTER LUNCH.
>> THAT'S GOOD.
>> WE WILL DELAY THAT
GRATIFICATION THEN.
[LAUGHTER]
>> BUT I DO WANT TO OFFER
DEBORAH AN OPPORTUNITY TO SAY
WHAT SHE WILL ABOUT THE CURRENT
STATUS OF THINGS.
>> THANK YOU.
I THINK THAT ONE OF THE THINGS
THAT CAME WITH THE MOVE TO NCBI
WAS THE DIRECTOR OF NIH TO GET
MORE FUNDING AND HIRE MORE STAFF
IN LARGE PART TO HELP PEOPLE
ENTER THEIR RESULTS THAT WE WILL
BE ABLE TO GIVE PEOPLE
[INDISCERNIBLE] PEOPLE IN THE
MEDICAL CENTERS, AND ELSER AND
ONE-ON-ONE HEALTH WHEN THEY COME
IN FOR THE RESULT.
LARGELY BECAUSE OF THE POLICIES
THAT THE DOCTOR TALKED ABOUT THE
RULE MAKING AROUND THE
[INDISCERNIBLE] AND THE PROPOSED
NIH POLICY AND CLARIFY COVERS
AND ALL POLITICAL TRIALS FUNDED
BY NIH, SO [INDISCERNIBLE] CHILD
DEVELOPMENT, SO, IT'S AN
EXCITING TIME AND YOU HEAR MORE
OF THAT.
SO I'LL PUT IN A PLUG, WE'RE IN
A PUBLIC COMMENT PERIOD FOR
THOSE POLICIES AND WE WOULD LOVE
FOR YOU TO COMMENT THERE, WE
CALL IT A LARGELY BUREAUCRATIC
PEOPLE BUT THERE ARE SCIENTIFIC
ISSUES IN THERE, WE WROTE AN
ARTICLE IN THE NEW ENGLAND
JOURNAL WHICH I CAN GIVE YOU
COPIES OF WHICH OUTLINE THE KEY
SCIENTIFIC ISSUES AND ANYONE
COMMENTS, THAT WOULD BE GREAT.
>> YEAH, I THINK ONE THING WE
DID TALK TO THE BOARD ABOUT A
LONG, LONG TIME AGO WHEN ALL
THIS WAS UNROLLING IS A
REQUIREMENT IN THE LAW THAT
SAYS, WE'RE NOT TELLING YOU TO
DO THIS BUT WE'RE TELLING YOU TO
COMMENT AND MAKE A
RECOMMENDATION.
AND IT IS A POSSIBILITY THAT NLM
ITSELF OR MAYBE NIH MORE BROADLY
WOULD UNDERTAKE TO CREATE PRO
SUMMARIES OF THE RESULTS OF THE
TRIALS THAT ARE UNDERSTANDABLE
TO THE PUBLIC AND TO THE
DOCTORS.
MORE OR LESS, END QUOTE AND
AFTER ABOUT HALF A SECOND
CONSIDERATION, WE DECIDED THIS
WOULD BE ABSOLUTELY TERRIBLE TO
UNDERTAKE, WE JUST COULDN'T DO
IT SO THAT IS YET TO BECOME
ADDED ON, BUT NIH'S ENDORSED OUR
VIEW AND THE SECRETARY OF THE
DEPARTMENT AS WELL, THAT WE
DON'T RECOMMEND DOING THAT, BUT
THE LAW STILL REQUIRES THAT WE
EITHER DO IT OR SAY WHY NOT?
>> WELL, I THINK THAT
THE--ANOTHER FEATURE OF THIS IS
THAT IF YOU LOOK AT IT,
OBVIOUSLY IT WOULD BE
EXTREMELY--IT WOULD BE
IMPOSSIBLE FOR NLM OR FDA TO
SUMMARIZE THE TRIAL FOR WHICH WE
DO NOT HAVE THE DATA AND HAVE NO
RIGHT TO DEMAND THE DATA SO
THAT'S ONE THING.
BUT THE FOCUS OF THE LAW WAS,
WELL, SHOULD THE PEOPLE WHO ARE
SUBMITTING THE RESULTS, THAT IS
THE PEOPLE WHO SPONSOR THE TRIAL
OR WHO ARE THE PRINCIPLE
INVESTIGATORS PRODUCE THESE
SUMMARIES, EITHER PRO SUMMARY.
I THINK NLM'S POSITION ON THIS
IS THAT, THERE'S A LOT OF
EVIDENCE OUT THERE THAT YOU DO
NOT GET A--THE MOST, SHALL WE
SAY, EVEN HANDED UNCOLLORRED
VIEW OF WHAT THE TRIAL
ACCOMPLISHED FROM EITHER THE
PINS PEL INVESTIGATOR OR THE
SPONSOR AND YOU KNOW AND WE WERE
CONCERNED IN SOME SENSE ABOUT
ENDING UP IN A SITUATION WHERE
WE WERE MAKING BROADLY
AVAILABLE, YOU KNOW SORT OF THE
VIEWS THAT PEOPLE MAY HAVE AN
INHERENT BIAS IN TERMS OF TRYING
TO DESCRIBE HOW WONDERFUL THE
RESULT OF THE REGULAR DEVICE
TRAVEL IS AND EVEN IF THEY HAVE
NO INHERENT OR DON'T THINK THEY
HAVE A BIAS, YOU KNOW YOU'RE
EXCITED AND PROUD OF YOUR OWN
WORK AND THERE HAVE BEEN STUDIES
DONE BY [INDISCERNIBLE] INTERNAL
MEDICINE OR WHATEVER, TO SAY,
HOW MANY OF THE SUMMARIES THAT
THESE TRIALS DID WE HAVE TO
REVISE IN PEER REVIEW, BECAUSE
PEOPLE WERE SORT OF THEY--THE
RISING AHEAD OF THE ACTUAL DATA
OR THE RESULTS OF THE TRIAL.
PLUS, HOW MANY WAYS CAN WE
INTERPRET THE DATA OF THE TRIAL.
SO, THERE ARE QUESTIONS BEING
ASKED IN THERE ABOUT THIS ISSUE
ABOUT THE--AND THEY'RE ALSO
ASKING WHETHER IT WOULD BE
GOOD--YOU KNOW ISSUES ABOUT HOW
MUCH OF THE PROTOCOL TO GO
THROUGH AND JERRY WILL SUMMARIZE
MORE OF THESE ISSUES THIS
AFTERNOON BECAUSE THERE REALLY
ARE SOME INTERESTING SCIENTIFIC
QUESTIONS AND YOU MAY HAVE VERY
WELL HAVE PEOPLE IN YOUR--IN
YOUR ORGANIZATION JUST NOT
PERSONALLY WHO MIGHT WANT TO
WEIGH IO.
>> WITH AN EARLY EARLY COMMENT
NAMED ESOB--WHO SPOKE ABOUT THE
FOX GUARDING THE HEN HOUSE.
[LAUGHTER]
NOW WE HAVE GIVE OUTS FOR YOU
CALLED LEGISLATIVE SUPPLEMENT
THAT THAT'S WHO'S ON WHAT
COMMITTEES AND CHRISTINE HAVE
YOU A STACK OF THESE SOMEWHERE?
>> OKAY, SO THAT'S--THAT'S THE
TAKE HOME.
>> OKAY, SO THAT'S EVEN BETTER.
SO THE SUMMARY OF THESE IS
PRETTY COMPLEX, I GUESS SOME
WOULD BEAR A LITTLE LIGHTER
TOUCH AND OBVIOUSLY THE CHANGE
IN THE MAJORITY THERE'S NO CLACK
I WOULD SAY OF GOOD WILL FOR THE
SOURCE OR NLM, WE'RE SURROUNDED
BY WELL WISHERS AND NOW WE'RE
SURROUND BIDE LEGISLATIVE
PROPOSALS.
TO COVER AN ENORMOUS NUMBER OF
CONSIDERATIONS, 20th CENTURY
CURE IS ONE WHICH IS BUT ITI
SENTIALLY SAYS WE WANT TO TAKE
CARE OF AN ENORMOUS THINGS IN
PLAIN APPROPRIATIONS BLUE RIBBON
COMMISSION ON SCIENTIFIC
LITERACY TO DEVELOP A NEW
APPROACH TO REDUCE THE AVERAGE
AGE OF INVESTIGATORS GAINING
THEIR FIRST RO-1 FUNDING, WE'VE
DISCUSSED THIS MANY TIMES AND
THEY'RE VALID POINTS JUST
HOLDING OFF AND SAYING SOMETHING
ABOUT THEM DOESN'T GET A CHANGE
TOO FAST BUT YOU'LL HAVE AN
OPPORTUNITY TO TALK ABOUT THAT
PARTICULAR ISSUE SO THE
LEGISLATION INCLUDES MANY, MANY
INTERESTING AND WELL THOUGHT
THROUGH PROBLEMS BUT WITHOUT
GIVING TOO MUCH RELEASE.
SO, ONE PROBLEM OF WHY IS THIS
SO DARN DIFFICULT TO GET GRANTS
AND WHY AREN'T OLDER GUYS
GETTING GRANTS WELL YOU COULD A
IT'S A SHORTAGE OF MONEY AND
MAYBE IT'S TOO MANY GOOD IDEAS
OR MAYBE BOTH TOGETHER BUT IT
ISN'T EASILY SOLUBLE WITHOUT
SPENDING SOME MONEY.
ANOTHER THING THAT BRINGS TO
YOUR ATTENTION IS I GUESS WE
WOULD SAY A SALUBRIOUS TENDENCY
TO WANTING INFORMATION TO BE
AVAILABLE AND THE CONGRESS QUITE
A FEW YEARS AGO ACTED TO FOR NIH
GRANT RECIPIENTS FOR RESEARCH
WOULD MAKE IT AVAILABLE TO THE
PUBLIC, OF COURSE THE MONEY IS A
RESULT OF THE PUBLIC AND THERE'S
LOTS OF DIFFICULTIES IN GETTING
THAT ACCOMPLISH BUT PUBMED
CENTRAL ENDED UP BEING THE
REPOSITORY THAT IS TO SAY, NLM
AND NCBI SOFTWARE TO ALLOW THESE
MACHINEABLE DRAFTS OF OF REPORTS
FOLLOWING THE RESEARCH IN THE
YEAR AND THEN ACCEPTED BY
JOURNALS TO BE MADE PUBLIC.
OF COURSE THERE'S A VAST CHORUS
FOR WHY IT SHOULDN'T BE DONE AND
IT SHOULD BE DONE AND ONCE
THEY'RE DONE, EVERYONE SAYS
GOLLY, THAT'S PRETTY NICE AND
THERE'S MORE THAN TWO MILLION
ARTICLES IN IT, PROBABLY CLOSER
TO THREE NOW SO IT'S PRETTY
HEAVILY USED AND OTHERS HAVE
INCLUDE OFFICE OF DIVERSITY IT
INCLUDES CONGRESS AND THE FINAL
ACTION WAS A PIECE OF
LEGISLATION THAT ESSENTIALLY
SAID ALL OF THE AGENCIES IF THEY
SPEND AS MUCH AS I GOES THE
HUNDRED MILLION DOLLARS A YEAR
IN RESEARCH NEED TO PROVIDE SOME
WAY THAT THAT RESEARCH CAN BE
GOTTEN TOO BY DEVELOPING PEOPLE
INCLUDING THE PUBLIC.
ONE OBVIOUS POSSIBILITY TO THROW
IN WITH NLM.
SO WITHIN HHS, THE REQUIREMENT
IS AN ARC AND CDC AND FDA WHO
ARE IN FACT THROWING IN WITH US.
D. O. E. IS SET TO DECIDED--
>> IT HASN'T.
IT'S NSF WHO IS STILL UNDECIDED
AT THE TIME.
>> BUT D. O. E. IS NOT DONE?
>> YES, THEY DECIDED AGAINST.
>> THEY HAVEN'T DECIDED WHICH
COUNTRY OR AGENCY THEY'RE GOING
TO GO WITH.
SO NSF WOULD BE VERY IMPORTANT
AND MANY OF THE AGENCIES HAVE
LOOKED CAREFULLY AS HELPFUL AS
THEY POSSIBLY CAN SO MUCH OF IT
WILL END UP IN THE SAME
MANAGEMENT SCHEME AND I WOULD
SAY BIGGER, NIH IS BIGGER THAN
ALL OF THE REST OF THEM BY QUITE
A BIT.
SO WE'RE NOT--WE'RE NOT SAYING
WE WILL BE OVERWHELMED SO I
GUESS UNLESS YOU WANT TO ASK
FURTHER ABOUT THAT THAT'S SORT
OF THE BOTTOM OF THAT.
THE CYBERSECURITY IN YOU READ
THE PAPER, IT'S AS MUCH AS
ANYBODY SITTING NEXT TO YOU, BUT
THERE IS LEGISLATION THAT SAYS
DO BETTER.
THE NATIONAL CYBERSECURITY
CENTER INFORMATION AND SO FORTH.
SO WE WELL SERVED BY
IBER DESUZA, AND HIS COMPANY AND
HE WILL HAVE AN OPPORTUNITY TO
TELL YOU IN MORE DETAIL ABOUT
HIS COMPANY BUT BASICALLY WE'RE
AHEAD, IT APPEARS OF OTHER NIH
INSTITUTES AND BAD AS IT MAY BE,
NIH MAY BE BETTER OFF THAN THE
OTHER AGENCIES, HOPEFULLY WITH
SOME EXCEPTIONS, WE HOPE.
BUT THE GENERAL PICTURE IS A
DIFFICULT PROBLEM.
IT COSTS A LOT OF MONEY AND HIGH
PAID PEOPLE AND DIFFICULT TO
RECRUIT AND DIFFICULT TO RETAIN
PEOPLE.
WE GET AS MEN AS 10 OR 20,000
TIMES A MONTH TO ATTEMPT TO
SMASH THE SYSTEMS AND WE DON'T
HAVE ANYTHING CLASSIFIED.
IT'S RIDICULOUS, IT'S VULGAR
LITTLE BRATS THAT WANT THE RIGHT
TO SAY I DESTROYED SOMETHING.
NOT VERY DIFFERENT FROM THROWING
A BRICK THROUGH A PLATE GLASS
WINDOW.
THE PROBLEM WITH THAT IS IT WILL
COST US A LOT OF MONEY TO REPAIR
THE BROKEN SYSTEMS AND WE DON'T
WANT THAT TO HAPPEN.
SO THEY'RE DEFENDING US VERY
AVIDLY AND AGAIN HE'LL HAVE AN
OPPORTUNITY TO TELL YOU SOME
ABOUT THAT BUT BUT IN SUMMARY
THEY CAN BE PROUD OF WHAT
THEY'VE DONE.
NOW ANOTHER LITTLE TECHNICAL
COMPLEX THEY HAVE, I WON'T CALL
IT BUREAUCRATIC BUT A CHANGE
ANYWAY IN THE WAY OF DOING
BUSINESS BUT TAB F HAS TO DO
WITH FUNDING OF THE NATIONAL
NETWORK OF LIBRARIES OF
MEDICINE.
WHAT USED TO BE REGIONAL MEDICAL
LIBRARIES BUT OF COURSE INVOLVED
THOUSANDS OF OTHER INSTITUTIONS
AND A SYSTEM I CONSIDERED
AMAZING AND ADMIRABLE, WHEN I
FIRST CAME, I DISCOVERED
FOREIGNS COMING TO THE LIBRARY
FOR A WEEK, AND LOOKING FOR
SECRETS, LIKE YOU AMERICAN GUYS
ARE DOG SOMETHING RIGHT AND WHAT
ARE YOU DOING?
AND MY FIRST ANSWER WAS THE
NATIONAL NETWORK LIBRARY OF
MEDICINE AND THAT'S THE WAY THAT
THE LIBRARY WORKS AND WITH THE
WAY THEY WORK ALL OVER THE
COUNTRY TO ACHIEVE MUTUAL
DESIRES SO, IN THOSE DAYS THOSE
PROGRAMS WERE OPERATED AS
CONTRACTS AND WE'RE NOW
RECOMMENDING THAT CHANGE TO
OPERATE AS GRANTS AND THE ONLY
REASON TO SORT OF HAVE
MANAGEMENT OF CHURCH ON THE AND
CONTRACTS, LIKE PURCHASING, HAS
JUST BECOME ENORMOUSLY OFF THE
RAILS, FOR THE U.S. IN GENERAL.
I MEAN THE PRESIDENT'S COMMENTED
UP ON THAT SAYING THIS IS THE
WORST THING IN THE FEDERAL
SYSTEM.
SO FROM HIS POINT OF VIEW, THAT
INCLUDED HOW YOU GET SOFTWARE UP
TO ALLOW TO NOT ALLOW TO
SUBSCRIBE TO THIS CROSS
CONTAINMENT MEDICAL CARE ACT.
WHICH INVOLVED CONTRACTORS AND
NOBODY BASICALLY IN CHARGE AND
NOBODY WITH THE RIGHT TO WALK
INTO THE BAR'S OFFICE AND SAY
CHIEF THIS IS GOING SOUR.
YOU HAVE TO DO SOMETHING, YOU
HAVE TO STOP IT.
DON'T MAKE ANY MORE
ANNOUNCEMENTS OR PROMISES, THIS
IS BAD AND SEEMINGLY NO ONE DID
IT, BUT HE WAS SORT OF ACUTELY
AWARE OF THE LEGAL PROBLEMS WITH
CONTRACTING OUT THAT WORK.
AND JUST TO PAUSE FOR A MOMENT
TO EXPLAIN SORT OF THE GUTS OF
IT, AND THEN I'LL CONTRACT IT
WITH A WAY NLM ACTUALLY
OPERATING, SO THE WAY IT'S
SUPPOSED TO BE GIVE A
DESCRIPTION WHAT YOU WANT DONE
AND HAVE SOME PROCESS TO FAIR IS
A MAJOR PART OF GOVERNMENT
LEGISLATION AND THAT'S A GOOD
THING SO THROUGH A FAIR PROCESS
SELECT SOMEONE OR SOME COMPANY
TO DO IT, YOU TELL THEM WHAT YOU
WANT DONE AND THEY AGREE TO IT
AND THEN HANDS OFF, THEY GO OFF
AND SPEND YOUR MONEY AND RETURN
AT SOME POINT, PERHAPS EVEN
YEARS LATER AND GIVE YOU A
PRODUCT.
WELL, I MEAN THIS IS OBVIOUSLY A
TERRIBLE WAY TO BUILD.
YOU CAN IMAGINE IF YOU HAD FIVE
CONTRACTORS BUILDING YOUR HOUSE,
WHAT IT WOULD LOOK LIKE AT THE
END, NOT EVEN SQUARE.
SO THAT IS THE WAY THEY OPERATE.
THAT HEY THAT'S HOW YOU BUILD
MISSILE CRUISERS AND BATTLE
SHIPS AND AIRPLANES THAT FLY OR
DON'T FLY, TFX'S THAT ARE
SUPPOSED TO DO EVERYTHING FOR
EVERYBODY EXCEPT THEY CRASH
THROUGH A CARRIER DECK, ET
CETERA EET CETERA.
THERE IS ANOTHER WAY AND I GUESS
YOU COULD IF YOU CONTRAST IT
THAT SORT OF NORMAL PEOPLE
TERMINOLOGY, YOU COULD CALL A
OF COURSE PEOPLE AND GOOD
COMPUTER WORK, SO FIRST WE KNOW
WHAT WE'RE TALKING ABOUT.
WE'RE ASKING TO DO SOMETHING.
WE'RE NOT ASKING YOU TO GO OFF
INTO SPACE AND INVESTIGATE
GRAVITY.
WE KNOW WHAT WE WANT BUILT AND
WE UPON HELP YOU BUILD IT AND
WORK WITH YOU TO BUILD IT
STEP-BY-STEP AND PAY YOU TIME
AND MATERIALS, YOU KNOW BUILDING
A HOUSE.
SO THAT'S ALL THE DIFFERENCE IN
THE WORLD.
AND THAT PROCESS AS I SAY JUST
OVER THE 30 YEARS I'VE BEEN
HERE, GOTTEN WORSE AND WORSE AND
WORSE AND DEFIES THE PRESIDENT.
SO WE'RE GOING FORWARD RESEARCH
PROCESS OR ANY MIRACLE HAS
HAPPENED TO THEM BUT THEY DO
SEEM TO WORK AND THERE IS A WAY
TO WORK INTERACTIVELY WITH THE
AGENCIES AND THAT WOULD BE IN
THE MODE WE'RE PROPOSING TO WORK
WITH, THE NATIONAL NETWORK OF
LIBRARIES OF MEDICINE.
>> THE TIGHTER RESTRICTIONS OF
INTERPRETATIONS ON WHAT COULDN'T
BE DONE ON CERTAIN KINDS OF
CONTRACTS AND MOVED US INTO A
SITUATION WHERE DOING THE THINGS
WE WANT TO DO THROUGH THE
NETWORK AND SUCCESSFULLY IN THE
PAST WHICH IS FOR AN OUTREACH
PROJECT IT BECAME RESTRICTIONS
ON HOW LONG THEY COULD BE AND
WHEN THEY COULD BE LED AND WHAT
COULD BE DONE UNDER NEW
INTERPRETATIONS, NOT DONE BY OUR
CONTRACT OFFICE, BY THE WAY AND
JUST REDUCED ALL FLEXIBILITY TO
THE POINT WHERE THE MECHANISMS
SEEM TO BE COMPETING PERFECT.
GIVE US NEW OPPORTUNITIES AND
INVOLVE MORE PEOPLE AND HAVE A
COLLABORATIVE APPROACH TO THINGS
AND WE HOPE WILL SOLVE THAT
PROBLEM.
SO IF YOU WORRY IT WILL CAUSE A
GREAT BIG FIGHT?
WE DON'T THINK SO BECAUSE THEY
ANNOUNCED THIS SYSTEMATICALLY
AND LOTS OF DISCUSSIONS AND ALL
FAVORABLE SO WE'RE THINKING IT
WILL BE A SMOOTH TRANSITION BUT
WHO KNOWS.
NOW THE NEXT TAB OF G, HAS
SOMETHING TO DO WITH HIRING
PATHWAYS PROGRAM.
WE'RE NOT SURE HOW IT GOT IN BUT
IT'S A GOOD THING.
IT'S SORT OF LIKE GOING--GOING
BACK IN HISTORY TO INVENT THE
FUTURE.
I THINK IMMEDIATELY OF KEN
SMITH, FINE DUPEITY FINE PERSON
AS WELL, AND HE TOLD ME WHEN HE
WAS GRADUATING FROM COLLEGE
HOBART?
STEVE IS THAT HOBART?
YEAH, YEAH, HE WANTED TO WORK
WITH THE FEDERAL GOVERNMENT AND
HE WANTED TO IMPROVE MANAGEMENT
AND HE IS A GOOD STUDENT AND HE
DID TEST AND HE GOT HIRED ON
SOME LOWER LEVEL AND WORKED HIS
AND BEST MANAGED OF THE FEDERAL
GOVERNMENT AND THE OFFICE OF
PERSONAL MANAGEMENT IS SET
AGAINST ANY JUST SIMPLY GOOD
WELL QUALIFIED AMBITIOUS MAN AND
WOMAN TO JUMP IN AND GO SOME
PLACE, THEY DON'T QUALIFY FOR
THIS, THAT, OR THE OTHER REASON.
SO SOMEHOW OR ANOTHER THIS
ADMINISTRATION HAS MANAGED TO
REINVENT SOMETHING CALLED THE
PATHWAYS FOR RECENT GRADUATES
AND IT'S LIKE THE OLD DAYS,
THEY'RE ACTUALLY ADVERTIDESSING
IN COLLEGE CAMPUSES FOR YOUNG
PEOPLE WITHIN TWO YEARS OF
COMMENCEMENT SO YOU KNOW
YOUNGSTERS TO JUMP INTO THE
GOVERNMENT AND COMPETE FOR THE
GOVERNMENT JOB AND GET A FAIR
SELECTION FOR A JOB AND IF
THEY'RE ELIGIBLE THEY COULD BE
PUT ON FULL-TIME.
SO IT'S A WONDERFUL PROGRAM WITH
A BIT OF ADJUSTING I THINK WE
HIRED AND 17 PEOPLE, AND SO LOTS
OF GOOD PEOPLE, GOOD YOUNG
PEOPLE, MOTIVATED TO WANT TO
WORK SO WHAT'S WRONG WITH THAT
SO ANYWAY, THEY CAN ACTUALLY DO
GOOD THINGS STILL IN FEDERAL.
>> [INDISCERNIBLE]
>> TREMENDOUS NUMBERS NUMBERS
OF
APPLICANTS AND WE'RE EXCIDED
ABOUT ALL OF THEM.
WONDERFUL.
>> SO BACK TO THE FUTURE.
SO THE NEXT TAB TO BRING
NONAPOPTOTIC YOUR ATTENTION IS H
THIS HAS TO DO WITH BD2K
INITIATIVE UPDATE, SO THIS IS
BIG DATA TO KNOWLEDGE THAT'S
WHAT THE SYMBOLS MEAN.
IT'S NOT A BAD IDEA BUT WE'VE
BEEN IN THAT BUSINESS EVER SINCE
WE'VE BEEN A LIBRARY HERE SO
IT'S NOT REALLY A NEW CONCEPT,
IT'S BEEN PUSHED BY NSF AND NIH
SOMEWHAT TRAPPED INTO THIS, BUT
ANYWAY ONE OF THE MOON SHOTS
THAT'S GOING ON ONE THAT NIH'S
ULTIMATELY AND IT WILL INVOLVE
GRANTS TO UNIVERSITIES AS USUAL
AND RESEARCH CENTERS AND
COMMITTEES AND ALL THAT STUFF
BUT TWO RESEARCHERS ARE KNOWN BY
THE NLM SIDE AND IF HAVE HAD OUR
SUPPORT, AND IF THE PLANES WORK
AND THE TRAINS WORK OR ANYTHING
ELSE WORKS, GEORGE WILL PRESENT
THIS TO YOU LATER AT THE MEETING
AND HE'S A GOOD PERSON AND I
WOULDN'T TAKE ANYTHING AWAY FROM
HIM WHETHER IT IS IDEA'S SUPER
IDEA OR JUST A GOOD IDEA.
IT'LL DO A GOOD JOB OF IT.
THE CENTERS OF EXCELLENCE OF
COURSE ARE IN THIS NEXT AS WELL,
BUT AGAIN IS THAT A NEW THING, I
MEAN IT IS AND I'VE SEEN AT
LEAST FOUR CYCLES OF NIH FUNDING
COMPUTER CENTERS ON UNIVERSITY
CAMPUSES.
HOW MANY HAVE YOU SEEN BOB?
SOMETHING ROUGHLY LIKE THAT?
>> IT GOES IN WAVES.
>> GOES IN WAVES AND THERE'S
ENTHUSIASM, START IT, AND YOU
PUT DOWN MONEY WILL SOMEONE TAKE
IT, YEAH, PROBABLY BUT THE
UNIVERSITY PERSON, MAYBE GET
GOOD WORK DONE AND THEN WHAT?
>> THEY ALL PROMISE
SUSTAINABILITY AND THEN THEY
NEVER--
>> YEAH, YEAH, WHAT WOULD IT
TAKE TO GET SUSTAINABILITY?
>> PARTICULARLY WEST COAST HAVE
SEEN IT, I DON'T LIKE WHEN IT
DID TO ME AS A COMPUTER CENTER
DIRECTOR WAS IT CHANGED MY VIEW
OF COLLEAGUE, INSTEAD OF A
COLLEAGUE BEING AN INTERESTING
PERSON WHO CAME IN MY OFFICE AND
SAT DOWN AND TOLD ME ABOUT A
GREAT IDEA, HE BECAME A
POTENTIAL CLIENT, YOU KNOW
PAYING FOR SERVICES AND IT WAS A
MISERABLE VIEW.
I DETESTED IT.
I RAN A COMPUTER CENTER FOR
YEARS AND ALSO IN THE SAME MONTH
WE BOTH GAVE IT UP AND WE DIDN'T
GO OUT ON A BIG BANG BUT WE DID
LIFT A GLASS OR TWO IN RELIEF
AND DELIGHT.
SO WHAT WE SEE FROM THE PAST IS
ANOTHER CYCLE POSSIBLY STARTING
UP AGAIN BUT THE BASIC IDEA THAT
BIG DATA KNOWLEDGE MANAGEMENT
PRONE AND IS FAIR ENOUGH AND
SOME OF THE BIGGEST DATA IN THIS
CAMPUS HAS BEEN RIGHT HERE AT
NLM.
I MEAN THE--THE VISIBLE HUMAN
WAS THOUGHT TO BE IMPOSSIBLY
DIFFICULT TO CARRY FORWARD AND
POSSIBLY DIFFICULT TO STORE AND
TRANSMIT AND ALL THOSE THINGS
AND THEY ARE ALL TRIVIAL NOW.
NOT EXACTLY TRIVIAL BUT DOABLE,
CLEARLY DOABLE.
AND ALL OF OF THE GENOME WORK
AND SEEMINGLY HUGE BUT IN FACT
DOABLE, WITH NOW NOT HAND HELDS
BUT AT LEAST DESK LEVEL LAPTOPS
BUT HAVE THE POWER WHAT WE USED
TO CALL SUPER COMPUTER.
I DON'T THINK THE PEOPLE GOT ANY
SMARTER BUT [INDISCERNIBLE]
BETTER, RIGHT, BOB?
>> RALPH'S BEEN REPRESENTING US
ON THE MULTICOUNCIL AND
REVIEWING THESE AWARDS BEFORE
THEY ARE AWARD AND HE'S BEEN ON
THE COUNCIL WOULD YOU LIKE TO
MAKE COMEBTS.
>> I CAN SUMMARIZE, I DON'T KNOW
WHAT EVERYBODY KNOWS ABOUT THE
BD2K, IT'S A BIG TRANS-NIH
PROGRAM, IT REPORTS TO FILL
BORN, THE ASSOCIATE DIRECTOR FOR
DATA SCIENCE WHO REPORTS
DIRECTLY TO DR. COLLINS.
THEY HAVE LOTS OF STRUCTURES
WHICH I HAVEN'T PARSED, THERE'S
SCIENTIFIC DATA COUNCIL THAT
BETSY IS ON WHICH ADVISES BOARD,
WE HAVE MIKE GUERTA AND GEORGE
ON THE EXECUTIVE COMMITTEE AND
WE HAVE ALTERNATES ON AND I'M ON
THE MULTICOUNCIL WORKING GROUP
WHICH PROVIDES SECONDARY INPUT
COMMENTS ON RECOMMENDING AWARDS
TO WHAT THEY THINK SHOULD BE
MADE VERY MUCH LIKE THE
EXTRAMURAL COMMITTEE HERE DOES
ON AWARDS AND I WAS THINKING OF
MAKING, BUT JUST TO GIVE YOU THE
SCOPE, THEY LAUNCH THESE 12
CENTERS OF EXCELLENCE WITH 32
MILLION DOLLARS, A DATA
DISCOVERY COORDINATION AND
CONSORTIUM AND TRAINING AWARDS.
THE MONEY IS IN THE BEGINNING
COMING FROM THE COMMONS FUND,
COMMON FUND, BUT IT'S BUT IT'S
SUPPOSED BE TRANSITIONED FROM
THE ICs.
>> IT'S ACTUALLY STARTING WITH A
COMBINATION THAT'S ALL OF THESE
PARTS OF NIH GET A SPECIAL PATH
TO PROVIDE SOME OF THE MONEY FOR
BD2K AND SOME OF IS THE COMMON
FUND AND THE COMMON FUND
PROPORTION DESIGNED TO GO DOWN
AND THE PART THAT IS COMING FROM
THE BUDGET [INDISCERNIBLE] RAMP
UP OVER A PERIOD OF HOW MANY
YEARS--
>> BUT IF YOU LOOK AT WHAT THEY
DEAL WITH, THEY DEAL WITHSTAND
ARDS, SOFTWARE INDEXING, DATA
SUSTAINABILITY THOSE ARE ALL
THINGS THAT ARE VERY NATURAL
HERE THEY'RE ALSO MAKING A
CONCERTED EFFORT TO REACH OUT
INTO OTHER COMMUNITIES LIKE MATH
AND STATISTICS AND COMPUTER
SCIENCE AND SO ON THAT WILL
BRING--NOT ONLY ARE THE COMPUTER
GOTTEN BETTER BUT THE ALGORITHMS
HAVE GOTTEN BETTER AND IT'S DUE
TO THOSE KINDS OF INFLUENCES FOR
FY15 THEY HAVE 60 MILLION
DOLLARS EITHER ALLOCATED OR
COMMITTED TO ACTIVE AWARDS AND
19 MILLION THEY HAVEN'T FIGURED
OUT WHAT THEY'RE GOING TO DO
WITH THAT ARE AVAILABLE FOR ONE
YEAR AWARDS SUCH AS
ADMINISTRATIVE SUPPLEMENTS OR
CLOUD PILOTS OR DIVERSITY
ACTIVITY, COMPETITIONS, PRIZES,
ET CETERA.
SO IT'S SOMETHING THAT NLM IS
PAYING ATTENTION TO.
AND AN OPPORTUNITY TO SUPPLEMENT
THE THINGS WE'VE BEEN TRYING TO
DO ALL ALONG.
>> AGREED.
>> [INDISCERNIBLE]--THERE'S TOO
MUCH LABOR UNLESS THEY REALLY
PUSH THE STANDARDS AND NLM HAS
BEEN A MANTRA BUT I'M NOT SURE
MAYBE [INDISCERNIBLE].
>> WELL I THINK THAT THEY ARE
VERY INTERESTED IN PUSHING
STANDARDS, I THINK THERE ARE A
LOT OF SMART PEOPLE INVOLVE WIDE
THESE AWARDS AND AND THE
APPROACHES THAT HAVE BEEN TAKEN
TO PURSUING SOME OF THESE
OBJECTIVES ARE NOT NECESSARILY
IN LINE WITH SOME OF THE ADVICE
OR RECOMMENDATIONS THAT WERE
GIVEN BY NLM TO BEGIN WITH BUT
I'M SURE THERE WILL BE GOOD
RESULTS COMING FROM IT.
>> STILL POSSIBLE TO RUN OUT OF
MONEY BEFORE YOU RUN OUT OF GOOD
IDEAS.
>> OKAY, NOW THERE ARE TWO MORE
THINGS I WANT TO DO ONE IS TO
TALK ABOUT PILL IMAGING THIS, IS
A SCHEME THAT MIKE ACKERMAN GOT
GOING.
BUT THE IDEA IS THAT PILLS ARE
PACK KNOWLEDGED UP IN DIFFERENT
COLORS AND FORMS AND SHAPES BUT
THE DIFFICULTY HAS NOT CHANGED
SINCE I WAS PRACTICING IN
NEW YORK CITY WHERE PEOPLE SHOW
UP FROM LONDON AND MILAN AND
PARIS ALL THE TIME.
PERFECTLY GOOD PEOPLE, NOT DRUG
ADIC ASKS THEY SHOW UP WITH A
LITTLE PURSE OR BROWN BAG AND
THEY SAY HERE'S THE DRUGS THAT
I'M TAKING AND THEY'RE
LEGITIMATE DRUGS BUT THEY HAVE
NAMES THAT DON'T MEAN ANYTHING
IN THE U.S. AND THAT STILL
HAPPENS.
OR IN THE DOMESTIC SIDE, THE
LADIES WITH THE LITTLE BROWN
BAGS THAT POUR THE THINGS OUT ON
YOUR DESK AND SAY THAT'S WHAT
I'M TAKING, I DON'T KNOW WHAT IT
IS BUT THAT'S WHAT I TAKE.
THE GREEN ONES I TAKE ONCE A
WEEK AND THE RED ONES I TAKE
THREE TIMES A DAY AND AGAIN, YOU
DON'T KNOW WHAT THE HELL THEY
ARE, SO THAT'S BEEN A PROBLEM
FOR A LONG, LONG TIME AND MIKE
ACKERMAN GOT TIRED OF HEARING
ABOUT IT AND DECIDED HE WOULD
JUMP IN AND TAKE HIGH QUALITY
PICTURES LIKE EVERYTHING ELSE WE
DO IS MADE AVAILABLE AT OUR
CHARGE TO PEOPLE AND THEN DEVISE
AND THEN WHAT YOU POINT YOUR
CELL PHONE AT THIS STUFF THEY
SAY LOT OF TIME, AND SOMEHOW OR
ANOTHER GET A COMPUTER TO KIND
OF FIGURE OUT WHAT IT IS.
THIS IS BROADLY WHAT YOU'RE
AFTER AND VERY FEW PEOPLE IN A
ROOM THIS SIZE DON'T HAVE
THEMSELVES OR A RELATIVE WITH
THIS PROBLEM.
THEY CHANGE PILLS AND THEY LOOK
DIFFERENT.
OKAY, WHAT'S HAPPENED SO IN THE
FDA, ISSUES NUMBERS FOR THESE
THINGS PRETTY MUCH WHOLESALE SO
THE NUMBER THAT'S ASSOCIATED
WITH THE PILL IS A DIFFERENT
NUMBER IF IT'S PACKAGED LIKE 25
PER BOTTLE OR 75 OR A HUNDRED,
ALL THREE OF THE NUMBERS.
AS OPPOSE TO THE ACTIVATION SO
NLM HAS BEEN ON THE SIDE OF THE
AGENT ANYWAY, THINGS ARE
CHANGING AND FDA DID SUPPORT
THIS INITIATIVE AND I THINK VA
AS WELL AND KISER.
SO THE THING HAS SOME FACE
VALIDITY BUT IT'S HARD TO DO.
HERE'S A SIMPLE MINDED IDEA BUT
IT'S HARD TO DO SO IT GIVES YOU
AN EXAMPLE--IS MIKE HERE?
YEAH, MIKE'S HERE, HIS DAUGHTER
Ph.D. COMPUTER SCIENTIST,
UNIVERSITY APPOINTMENTS AND ALL
THAT AND HE TOLD HER ABOUT IT
AND SHE SAID POP, THAT'S EASY.
MY FOURTH YEAR CLASS CAN DO THAT
BUT THEN IT TURNS OUT, LNOT
REALLY QUITE BECAUSE THE PILLS
TAKE A DIFFERENT SHAPE DEPENDING
ON THE LIGHT, DIFFERENT COLOR
DEPENDING ON THE LIGHT AND THE
BACKGROUND AND ON AND ON AND
ON.
SO IT'S A TOUGHER PROBLEM THAN
THAT.
IT'S NOT TOTALLY TOUGH, BUT THE
GROUP DOWN STAIRS HAVE THE IDEA
THAT THEY'LL MAKE THIS CROWD
SOURCING, WOULD YOU CALL IT A
CHALLENGE.
SOMETHING LIKE MIGHT PRODUCE
UNITS SO IT'S A PUBLIC THING
WITH LOTS OF PEOPLE SUPPORTING
IT PEOPLE MUCH SMALLER THAN IN
THE WAY TO KEEP IT GOING SO
THEY'RE GOING TO TRY THIS AND I
THINK THEY WILL TRY TO GET
AUTHORIZATION FOR A PRIZE BUT
THAT HASN'T WORKED OUT YET BUT
THAT WOULD BE THE IDEA AND THE
FIRST STEP IS THEY HAVE ROUGHLY
300 OF THESE SOLID R. O. DOSAGE
PHARMACEUTICAL PILLS FOR THEM
AND THESE REPRESENT WHAT MIKE
JUST SENT.
30% OF ALL THE FDA LISTED
PRODUCTS SO THEY'RE GROWING IT
BEYOND THE 3000 BUT IT'S ALREADY
PRETTY SUBSTANTIAL.
SO THE NUMBER OF IMAGES THAT
THEY PUT OUT, YOU KNOW THEY'RE
SHARING THIS AND IN 2014,
ACCORDING TO REPORTERS,
ESSENTIALLY TWO AND HALF
MILLION.
SO YOU ASK YOURSELF, I MEAN WHY
WOULD--WHO CARES?
WELL BECAUSE THERE IS NO OTHER
SOURCE OF GOOD LABELED IMAGES
THAT YOU ACTUALLY CAN BELIEVE
IN.
AND SO THEY PUMP THEM OUT, YOU
KNOW 875 PER HOUR AND SO FORTH
BUT WHO WOULD HAVE AN INTEREST?
WELL IT TURNS OUT THAT THE STOP
HEALTHCARE INDUSTRY PEOPLE,
HUMANA, KISER, AVENTIST, ELI
LILLY, GLAXOSMITHKLINE, THEY'RE
DOWNLOADING THE IMAGES, SO THE
ONE WE WORRIED ABOUT IS
DOWNLOADING THE IMAGE IS
SOMETHING CALLED FIRST DATA
BANK.
BECAUSE WE'RE THINKING OKAY,
BACK IN COURT.
WE'RE GOING TO GET ARGUMENTS
FROM THIS INDUSTRY BUNCH AND
MIKE TACKLED THE BULL BY THE
HORNS AND IT TURNS OUT THEIR
VIEW IS, WE DO MAKE IMAGES AND
WE DO INVENT IMAGES AND THEY'RE
HARD TO DO AND THEY'RE EXPENSE
AND IF WE UNDERSTAND CORRECTLY
WE CAN JUST GET YOURS AND SELL
THEM.
ONE MORE GUY MAKING MONEY ON
THIS OUTFIT BUT THAT'S BASICALLY
FINE.
SO IT'S NOT GOING TO BE CONTEST
INDEED COURT BUT A HUGE NUMBER
OF THE BIG COMPANIES ARE
INTERESTED IN THIS STUFF EVEN
THOUGH IT'S CONCEPTUALLY SIMPLE,
TECHNICALLY HARD TO DO.
AND WHAT COUNTRIES?
WELL, U.S. AUSTRALIA, IRELAND
SINGAPORE, UKRAINE, ON AND ON
AND ON AND ON AND ON 172
COUNTRIES.
SO IT'S ONE MORE NEAT LITTLE
THING, KINDA CUTE AND KIND OF
FUN BUT I WOULD SAY
CONGRATULATIONS TO MIKE.
KD--SALLY APPLAUDS NOW THIS IS
ALSO INFORMATION YOU CAN'T USE
TOO WELL BUT IT'S THE 20th
ANNIVERSARY OF THE VISIBLE HUMAN
PROJECT AND I PAY TRIBUTE TO
DR. SMITH AND THE BOARD OF
REGENTS AT THAT TIME BECAUSE THE
IDEA OF VISIBLE HUMAN, WELL THE
IDEA OF IMAGING NOT JUST TEXT
WAS PART OF THE LONG RANGE PLAN
BACK IN 85, WHEN AND IF THE
COMPUTERS GET GOOD ENOUGH TO
HAVE PICTURES IN THEM, PUT THEM
IN, WE HAD NOTHING BUT THE
CHARACTERS SO WHEN THE
OPPORTUNITY ARRIVED FOR THE
COMPUTERS, IT TURNED OUT
THAT--THE HEART AND SOUL OF
MEDICINE IS REALLY ANATOMY, SO
PUTTING IN THE VISIBLE HUMAN WAS
A STRATEGY THAT WAS ADOPTED BY
THE BOARD AND THE FAITH THAT IF
WE DID OUR JOB, THE ENGINEERS
AND SCIENTISTS WOULD DO THEIRS
AND WE COULD STORM AND IT WAS
ATTESTED BY BY RAY SMITH, IN
FACT HE FLEW FROM CALIFORNIA,
LIKE ALL THE REST OF US AND,
WEST COAST BOARD MEMBERS ANYWAY,
BUT INSTEAD OF READING CATALOGS,
HE WROTE OUT A LONG, LONG
BEAUTIFUL MEMO ABOUT HERE'S HOW
YOU WOULD DO IT, HERE'S VECTORS,
HERE'S COORDINATES, HERE'S THE
TWO WAYS THAT WILL BOTH WORK AND
IT WAS A BEAUTIFUL ESSAY.
AND THEN HE SUPPORTED THAT AND
THE BOARD BELIEVED HIM AND I
GUESS ME TOO.
SO THAT'S A GOOD LITTLE
REMEMBRANCE.
MARSHAL NUREMBERG CELEBRATION IS
COMING UP ON MARCH 17 AND WHAT'S
INVOLVED THERE, YOU'RE ALL OF
COURSE INVITED,OOSE IT'S A
PUBLIC EVENT BUT BASICALLY IT'S
JUST FOR US TO THANK BRENNA
WISEMAN WHO IS THE WIDOW OF
NUREMBERG FOR DONATING PAPERS TO
NLM AND THEN ALSO DONATING THE
ACTUAL GOLD NOBEL PRIZE WHICH IS
THE FIRST ONE AT NLM--NIH
ANYWHERE AFTER ALL THE TALK
ABOUT THE WONDERS DONE AT NIH
BUT THIS IS THE FIRST PRIZE AND
OF COURSE NUREMBERG'S
ACHIEVEMENT IS REALLY
INTELLECTUALLY AS IMPORTANT AS
THE DOUBLE HELIX SO IT'S A
WONDERFUL THING AND WE'RE GLAD.
SO IT'S NOT A SCIENTIFIC
SYMPOSIUM.
IT'S SORT OF A THANK YOU TO THIS
GAL.
THE NEXT PAGE JUST TELLS YOU
ABOUT NATIVE VOICES TRAVELING
EXHIBITION BUT I THINK I WOULD
RATHER GIVE YOU A LITTLE
PRESENTATION OF THE ONLINE
VERSION OF THIS.
SO NATIVE VOICES HAS TRAVELED A
NUMBER OF PLACES.
I WILL SHOW YOU SOME OF THEM AND
WE CONSIDER IT A SUCCESS, TOO.
IT'S SORT OF ABOUT FINISH PHASE
ONE WHICH IS--I WOULD SAY, WHAT
WE OWE THE NATIVE POPULATIONS, I
MEAN, AMERICAN INDIANS, NATIVE
HAWAIIANS AND NATIVE ALASKA ANS
AND THEY ARE THE BASIS OF THE
EXHIBITION AND WE FELT AT THE
VERY LEAST WE WANT TO GO BACK TO
SOME OF THOSE--SOME OF THEIR
HOME PLACES SO WE DID THAT.
AND THIS IS AN UPDATED ONLINE
THING.
JOHN I DON'T KNOW HOW TO WORK
YOUR MICROSOFT THING.
[LAUGHTER]
[* MUSIC ]
>> A NEW TRAVEL EXHIBITION FROM
THE NLM EXAMINED HEALTH AND
WELLNESS AMONG CONTEMPIARY
AMERICAN INDIANS, ALASKA NATIVE
AND NATIVE HAWAIIANS, HONORING
THE NATIVE TRANSLATIONAL
RESEARCH DEGZ OF ORAL HISTORY,
NATIVE VOICES AND NATIVE
CONCEPTS OF HEALTH AND ILLNESS
EXHIBITION FEATURES PERSONAL
STORIES FROM NATIVE PEOPLES
ACROSS THE COUNTRY.
NOW ENCOMPASSING MORE THAN 200
INTERVIEWS THEY PRESENT THE
UNIQUE COLLECTIVE THAT EDUCATE
AND INSPIRE VISITORS.
THE NATIVE VOICES EXHIBITION
ORIGINALLY OPEN INDEED 2011 IN
THE ROTUNDA OF THE NATIONAL
LIBRARY OF MEDICINE IN BETHESDA
MARYLAND.
NOW THE EXHIBITION IS TRAVELING
ACROSS THE UNITED STATES FOR THE
NLM HOPES THE STORIES WILL RAISE
AWARENESS ABOUT HEALTH ISSUES
THAT ARE EFFECTING NATIVE
PEOPLES.
THE TRAVELING VERSION OF SMALLER
IN SIZE THAN THE NATIVE VOICES
EXHIBITION AND THE ROTUNDA OF
THE NATIONAL LIBRARY OF MEDICINE
BUT IT CONTAINS ALL OF THE VIDEO
INTERVIEWS OF THE ORIGINAL
PRESENTED ON iPADS WITH
ACCOMPANYS BANNERS.
THESE INTERVIEWS OFFER
PERSPECTIVES ON COMMUNITY
WELLNESS, THE INTERSECTION OF
MODERN MEDICINE AND TRADITIONAL
HEALING, SPIRITUALITY,
INDIVIDUAL RESPONSIBILITY AND
RESPECT FOR NATURE.
THE NATIVE VOICES EXHIBITION HAS
ALREADY TRAVELED TO A VARIETY OF
HOST LOCATIONS, INCLUDING
COLLEGES AND LIBRARIES, MUSEUMS
AND CULTURAL CENTERS, ART
GALLERIES AND MEDICAL CENTERS.
EACH MENU PROVIDES THE UNIQUE
OPPORTUNITY FOR LOCAL
COMMUNITIES TO ENHANCE THE
NATIVE VOICES EXHIBITION BY
SHOWCASING THEIR OWN ART AND
ARTIFACTS OR HOSTING IT DURING
POWWOWS OR OTHER COMMUNITY
EVENTS.
THE NATIVE VOICES EXHIBITION
ATTRACTS MEDIA INTEREST WHEREVER
IT TRAVELS, IT WAS EVEN
RECOGNIZED BY CONGRESS FOR ITS
CONTRIBUTION TO POSITIVE HEALTH
OUTCOMES FOR NATIVE PEOPLES.
THE NATIONAL LIBRARY OF MEDICINE
HAS A HISTORY OF WORKING WITH
NATIVE COMMUNITIES AS PART OF
THE LIBRARIES COMMITMENT TO MAKE
HEALTH INFORMATION RESOURCES
ACCESSIBLE TO PEOPLE NO MATTER
WHERE THEY LIVE.
WHEN IT TRAVELS, THE NATIVE
VOICES EXHIBITION HELPS TO RAISE
AWARENESS ABOUT THE STEPS NATIVE
PEOPLES ARE TAKING TO IMPROVE
THE HEALTH OF THEIR COMMUNITIES.
SO THIS GOES ON AND ON AND ON
QUITE A LONG WAY, WE WON'T LEAD
YOU THROUGH IT ALL BUT I WILL
SAY WE FINISHED THE FIRST PHASE
NAMELY PAY BACK FIST YOU WILL BY
BRINGING THESE BACK TO THE
RESERVATION WHICH IS ARE HIGHLY
VARIED AS IT TURNS OUT, MORE SO
THAN I THOUGHT AND THE NEXT
PHASE BASICALLY IS BACK TO
REGIONAL MEDICAL LIBRARIES.
THEY BACK THE SYSTEM AND THEY'VE
BEEN RESPONDING VERY POSITIVELY
SAYING YES WE LIKE THAT AND WILL
SHOW THOSE, KEEP THEM COMING.
NOW THE NEXT PHASE WILL BE
MANAGED BY AMERICAN LIBRARY
ASSOCIATION.
WE'VE DONE THIS WITH PAST SHOWS
AND THEY'RE QUITE GOOD AND THEY
KNOW HOW TO DO IT SO IT'LL
CONTINUE, WE HOPE OR A FIVE YEAR
CONTRACT WITH THE AMERICAN
LIBRARY ASSOCIATION.
JUST A MOMENT ABOUT HOW THE
RESERVATIONS THEMSELVES VARY,
BUT ONE OF THEM--WE STARTED OUT
SHOWING IS NORTH DAKOTA.
I WOULD SAY WHAT WE SAW THERE
OVER THE YEARS WE'VE WORKED WITH
THEM IS A TRIBE ABOUT TO BE
DESTROYED BY OIL MONEY.
I MEAN THEY STARTED OUT POOR AS
CHURCH ON THE MICE AND WE HAD A
PROJECT TO GET JOBS ON THE
RESERVATION, VARIOUS SUNDRY
EFFORTS AND WE SUCCEEDED BUT
ONCE THE GAS AND OIL STARTED
COMING UP, THEY COULD SIGN BIG
CONTRACTS LIKE YOU AUTHORIZE THE
TO DRILL 300 HOLES AND WITHOUT
REALIZING THAT--3000 HOLE
WITHOUT REALIZING THAT THE
EQUIPMENT NECESSARY TO DO THAT
WILL DETROIT EVERYTHING ELSE
INCLUDES THE MILES OF HIGHWAY
THAT THEY'RE RESPONSIBLE FOR SO
THAT TURNED OUT TO BE A BAD
OMEN, IN CONTRAST THE LAST ONE
WE WENT TO OKLAHOMA WAS A BIG
POSITIVE SURPRISE.
IT'S RUN BY THE CHICKA SHAW
NATION AND VERY, VERY NICELY
MANAGED AND VERY GOOD.
AND YOU ASK YOURSELF SHOULD A
TRIBE HAVE A LAWYER?
THEY BETTER OR THEY'RE GOING TO
GET THE KIND OF CONTRACT THE
NORTH DAKOTA PEOPLE GOT.
THESE PEOPLE HAVE BEEN VERY,
VERY WELL, I WON'T GO INTO
DETAIL BUT IT CONTRASTED SHARPLY
MY WAY OF THINKING OF TERRIBLE
MANAGEMENT AND GOOD MANAGEMENT.
SO WE'LL CONTINUE TO LEARN ALL
THAT.
ALASKA HAS ITS OWN PLACE, BUT
BUT THE WHOLE WORKING WITH THIS
SHOW HAS BEEN GREAT IN WORKING
WITH THE NATIVE PEOPLE WHICH IS
WONDERFUL, IT WAS EASIER WHEN WE
STARTED TO GET VISITORS HERE
THAN IT IS NOW, BUT THEY STILL
COME IN EASILY THROUGH BUSES AND
[INDISCERNIBLE] AND I DO HOPE
THAT YOU'LL SPEND ENOUGH TIME
PERHAPS LUNCH OR SOME OTHER TIME
TO LOOK A LITTLE BIT INTO THE
REEXHIBITION BECAUSE I THINK
IT'S GOING TO LAST AND I THINK
IT'S GOOD.
SO ANY OTHER QUESTIONS BEFORE WE
GET COFFEE?
ALL RIGHT.
THANK YOU.
[ APPLAUSE ]
>> WE WILL BREAK FOR 15 MINUTE
FIST WE COULD COME BACK AT 20
TILL INSTEAD OF A QUARTER TO
LISTEN, WE CAN GET MORE
DISCUSSIONS IN.
I TRIED TO GIVE US A FEW EXTRA
MINUTES TIME BECAUSE THIS IS A
VERY, VERY IMPORTANT TOPIC
COMING UP ON THE ADVISORY
COMMITTEE TO THE NIH DIRECTOR
WORKING GROUP ON THE NATIONAL
LIBRARY OF MEDICINE OF WHICH I
AM THE BOARD OF REGENTS
REPRESENTATIVE BUT I WOULD LIKE
TO START BY TURNING IT OVER TO
BETSY WHO WILL GIVE YOU AN
INTRODUCTION TO THE WORKING
GROUP THAT'S CHARGED AND WILL
ALSO INTRODUCE OUR GUESTS.
>> SO, YOU ALL WERE SENT COPIES
OF THE CHARGE AND THEY ARE IN
YOUR PACKET TO THE CHARGE AND
THE LIST OF MEMBERS OF THE
WORKING GROUP WHICH DOCTOR
COLLINS HAS FORMED TO CONSIDER
THE VISION FOR THE FUTURE OF NLM
AS PART OF BACKGROUNDS FOR THEN
GOING OUT TO RECRUIT FOR DON'S
SECTOR AND THE PLAN AS I
UNDERSTAND IT IS THAT THE
WORKING GROUP WILL BE WORKING
RAPIDLY AND COLLECTING INPUT
OVER THE NEXT SEVERAL MONTHS AND
WILL INFACT PRESENT TO--PRESENT
A REPORT OR SET OF
RECOMMENDATIONS OR IDEAS TO THE
FULL ADVISORY COMMITTEE TO THE
DIRECTOR AND IT IS THE FULL
ADVISORY COMMITTEE DIRECTOR WHO
THEN APPROVES OR AMENDS THAT AND
PASSES ON THE ADVICE TO
DR. COLLINS, LARRY HAS BEEN
SITTING OVER HERE IS THE PERSON
WHO IS PROVIDING THAT SUPPORT
AND ORGANIZATION AND MUCH MORE
THE STAFF REPORT OR TRYING TO
ORGANIZE THE THINGS FOR THE
WORKING GROUP AND WHAT WE KNOW
IS THAT THE THINGS HE'S
ORGANIZING AT THE MOMENT IS THE
FACT THAT THE WORKING GROUP IS
GOING TO ISSUE A REQUEST FOR
INFORMATION WHICH WILL BE FOR
ANYONE AND EVERYONE WHO IS--HAS
AN INTEREST IN THE NATIONAL
LIBRARY OF MEDICINE TO PROVIDE
INPUT TO THE WORKING GROUP AND
BECAUSE OF THEIR SCHEDULE, THEY
WILL-HAD THIS WILL BE ISSUED
MAYBE BY THE END OF THIS WEEK
AND WHENEVER IT'S ISSUED THERE
WILL BE 30 DAYS FOR PEOPLE TO
RESPOND TO IT.
AND OF COURSE, NLM WILL BE
PUBLICIZING THE FACT THAT THIS
IS THIS AND PEOPLE CAN PROVIDE
INPUT TO OUR WIDE GROUP OF HUGE
CONSTITUENTS.
THE COMMITTEE WILL--THE WORKING
GROUP WILL MEET AT NIH IN HERE,
IS THAT RIGHT?
THEY WILL BE MEETING IN THE
BOARD ROOM ON MARCH THE SECOND
AND THAT IS THE MEETING WHERE
THEY WILL, I THINK IN SOME WAYS
BE GETTING THE LAY OF THE LAND
ABOUT WHAT NLM IS ABOUT AND
THINGS ABOUT OUR CURRENT STATUS
AND SO FORTH FROM DON AND ME AND
OTHER MEMBERS OF THE NLM STAFF
AND THEN THAT WILL BE BACKGROUND
FOR WHAT THEY WILL THEN START
HEARING FROM THE PUBLIC OR THE
RESPONDENTS BECAUSE THEY'LL
PROBABLY BE DUE SOMETIME IN
MIDMARCH.
LYRIC HAS SAID THAT BECAUSE OF
THE ADVISORY COMMITTEE, THE
DIRECTOR'S SCHEDULE, THEY WILL
MEET ON JUNE 10th AND 11th
RIGHT, THAT THE FINAL REPORT OF
THE WORKING GROUP REPORT IT'LL
HAVE TO BE IN FINAL SHAPE BY THE
END OF MAY SO IT CAN CIRCULATE
IT OUT AND REPORT IT AND DISCUSS
IT AT THAT MEETING.
SO THEY'LL BE MOVING ALONG
QUICKLY AND THEY HAVE ANOTHER
MEETING HERE AT NIH IN APRIL AND
WE'LL IN ADDITION TO THE INPUT
RECEIVED THROUGH THE REQUEST FOR
INFORMATION WILL ALSO BE
PROBABLY DOING TELEPHONE
INTERVIEWS AND MEETINGS WITH A
VARIETY OF OUR INTERESTED
PARTIES AND AND SOME OF THAT
MIGHT BE FACE-TO-FACE BUT SOME
OF IT MIGHT BE, YOU KNOW
TELEPHONE.
THAT I THINK IS THE GENERAL
PROCESS STHAT RIGHT?
AND SO, I THINK THE ISSUE HERE
AS YOU KNOW TRUDY IS A PROBLEM
OF THE COMMITTEE AND WE WILL
RECOGNIZE THE NAMES, SOME OF YOU
OF MANY OF THE OTHER MEMBERS OF
VERY OBVIOUSLY DISTINGUISHED AND
KNOWLEDGEABLE GROUP AND I THINK
THE ISSUE HERE IS A DISCUSSION
OF WHAT MIGHT BE THE VARIOUS
WAYS THAT THE BOARD WOULD LIKE
TO PROVIDE INPUT TO THIS
PROCESS.
>> YES?
>> WHO WILL THAT GO OUT TO?
>> IT WILL GO OUT TO EVERYONE.
>> THE WORLD?
>> YEAH, THE WORLD AS ALL
REQUEST INFORMATION FROM NIH AS
THE THEY DO, THERE'S PUBLIC
DOCUMENTS SO THE ISSUE IS HOW DO
WE GET IT OUT FOR PEOPLE WHO
MIGHT BE INTERESTED MIGHT NOT
SPEND THEIR LIVES MONITORING THE
NIH GUIDE OR LOOKING FOR REQUEST
FOR INFORMATION.
>> SO EVERYONE WILL GET THIS?
>> [INDISCERNIBLE]
>> NO THIS IS A REQUEST FOR
INFORMATION.
>> NOT A REQUEST FOR
APPLICATION.
>> NO I UNDERSTAND BUT IT'S
USUALLY COUNTS IN THE CONTEXT OF
[INDISCERNIBLE].
>> SO I'M GOING TO READ IT IF
I'M ALLOWED TO A PREVIOUS
VERSION JUST TO GIVE YOU
THEORIES OF THIS, BUT THIS IS
NOT THE FINAL VERSION THAT WILL
BE DRAFT OFFICE OF DIVERSITY
FRIDAY.
>> JUST TO PARAPHRASE.
>> YEAH, BECAUSE I THINK THERE
WILL BE SOME QUITE EXPANSIONS.
>> SO SOME OF THE INFORMATION IS
WHAT CURRENT NATIONAL LIBRARY OF
MEDICINE ELEMENTS ARE MOST
VALUABLE TO BIOMEDICAL RESEARCH
COMMUNITY AND WHY, SO VERY, VERY
OPEN ENDED QUESTION SUCH AS
THAT.
AND THEN THE SAME QUESTIONS WITH
RESPECT TO HEALTHCARE PROVIDERS
AND PATIENTS IN THE PUBLIC.
SO, BASICALLY THEY WILL BE QUITE
BROAD SORTS OF QUESTIONS AND
THERE WILL BE AN ELECTRONIC
PORTAL FOR SUBMITTING THE
RESPONSES AND PETSY AND I
THOUGHT IT WOULD BE, MAYBE IF
THE BOARD AGREES, A GOOD IDEA TO
HAVE A BOARD RESPONSE TO THIS
REQUEST FOR INFORMATION.
SO IF WE COULD GET MAYBE
VOLUNTEERS FOR A SUBCOMMITTEE WE
COULD READ THROUGH IT CAREFULLY,
CONTACT YOUR INSTITUTES AND
DRAFT SOMETHING THAT REPRESENTS
THE OPINION OF THE BOARD SO THAT
WOULD BE ONE WAY OF VERY CLEARLY
ARTICULATING WHAT WE THINK AS
WE'VE BEEN VERY CLOSELY INVOLVED
WITH NLM AND ITS EVOLUTION OVER
THE YEARS.
I DON'T KNOW WHETHER PEOPLE
AGREE WITH WHAT--
>> MAYBE I MISUNDERSTOOD WHAT I
THOUGHT BETSY WAS ASKING BUT THE
SECOND, YES, I THINK A BOARD
RESPONSE WOULD BE GREAT BUT I
THINK YOU WERE ASKING FOR INPUT
THAT YOU WOULD BE PROVIDED TO
THE WORKING GROUP ON PROCESS FOR
GAINING INPUT AND ANSWERS.
>> I THINK THE ISSUE OF
ADDITIONAL WAYS THAT THEY COULD
GET INPUT, I THINK THAT
OBVIOUSLY, SUGGESTIONS COULD BE
MADE TO THEM ABOUT THAT.
THEY ARE OF COURSE, THE
DECISION'S BEEN MADE, THEY ARE
GOING TO ISSUE REQUEST FOR
INFORMATION, SO ADDITIONAL WAYS
THAT PEOPLE THOUGHT WOULD BE
HELPFUL THR THEM TO GET INPUT,
I'M SURE THEY WOULD BE HAPPY TO
CONSIDER THEM.
>> SO IN THAT LIGHT, I'M I'M
VERY PLEASED TO SEE SUCH A
THOUGHTFUL WELL REGARDED GROUP
CONVENE, BUT ALSO IN LOOKING AT
THE COMPOSITION OF THE GROUP, I
THINK IT WOULD BE HELPFUL TO
ARTICULATE A WAY TO PARTICULARLY
GET INPUT ON OUT REACH AND
COMMUNITY SERVICE AND
INVOLVEMENT BECAUSE IF I LOOK AT
THE COMPOSITION, THE
[INDISCERNIBLE] ARE HEAVILY
WEIGHED TOWARD INSTITUTION
VERSES PUBLIC INSTITUTION AND
PERHAPS YOU MIGHT NOT--YOU MIGHT
NOT--WELL MIGHT NEED ENHANCING
OUR DIRECT COMMUNICATION WITH A
PARTICULAR USER GROUP.
SO DOES THAT MAKE ANY SENSE
BETTS EATS IS WHAT I'M SAYING?
>> YEAH TDOES AND I THINK THAT
THAT'S SOMETHING THAT COULD BE A
VARIETY OF WAYS THAT COULD
PROVIDE THAT TO ORGANIZE A WAY
THAT SUGGEST PEOPLE TO PROVIDE
THAT PERSPECTIVE.
>> WE COULD START OUT WITH WHY
IS NLM DOING OUTREACH AT ALL.
>> I THINK YOU SHOULD ASK THAT
TO THE BENEFICIARY BECAUSE I
WORK BOTH IN PRIVATE
INSTITUTIONS AS WELL AS PUBLIC
INSTITUTIONS AND SO I SEE A VERY
STRONG DIFFERENCE IN EADMISSIONS
AND INSTITUTIONS AND I WANT TO
BE SURE THERE WAS A VERY--A VERY
ACTIVE WAY OF SOLICITING THAT.
IT WAS BACK IN 88 OR FINE I HAD
THE FIRST OUTREACH ESO THERE WAS
NO BUDGET FOR OUTREACH, NO
ADMISSIONS FOR OUTREACH AND
PRESUMABLY RAN A LIBRARY FOR THE
BENEFIT OF LIBRARIANS.
>> WELL AT LEAST FOR THE PEOPLE
WHO WERE AFFILIATED WITH THAT
LIBRARY.
>> WE GOT MONEY FROM BILL
NATCHER OR OUTREACH AND IN FACT,
EVERY YEAR WE TESTIFIED WE
FIGURED OUT AHEAD OF TIME HE WAS
GOING TO SAY, DOCTOR WHEN DID DO
YOU WITH THAT MONEY?
WHICH I THOUGHT WAS WONDERFUL
AND WE COULD TELL THEM DOWN TO
THE LAST TIME WHAT WE DO WITH
THAT MONEY.
SO I MEAN OUTREACH WASN'T EVEN A
HUMAN PART OF NLM ITSELF UP
UNTIL THE TIME THE CONGRESS GAVE
US MONEY FOR THAT PURPOSE.
>> WELL I JUST DON'T WANT THAT
LAW.
>> WELL I UNDERSTAND BUT I'M
TELLING YOU THIS IS AN NIH
BUNCH, THEY WILL NOT UNDERSTAND
WHAT OUTREACH IS, LET ALONE WHY
WE'RE DOING IT, SO YOU HAVE TO
HAVE A LITTLE COLLABORATE, NOT
JUST WE LIKE IT.
>> IT'S I THINK THAT'S WHY IT'S
IMPORTANT [INDISCERNIBLE] DIRECT
STATEMENT RELATIVE TO WHAT HAS
BEEN HAPPENING
[INDISCERNIBLE]--UNDERGOING AND
THE LAST THING WE TALKED ABOUT--
>> YEAH, LET ME COMMENT ON THAT
BECAUSE I SHOULD HAVE INTRODUCED
THAT TO BEGIN WITH PRIOR TO THE
PLANNING COMMITTEE, IT WAS PRIOR
TO US LEARN ING THAT DR. COLLINS
HAD THIS APPROACH.
AND ONE THING THOUGHT NOT
HELPFUL TO ANYONE WOULD BE IF
THE PUBLIC OR CONSTITUENTS
THOUGHT WE HAD ESTABLISHED THE
BOARD OF REGENTS AND THE OFFICE
OF THE DIRECTOR OF NIH WERE
HAVING DULY PLANNING PROCESSES
SO I THINK THAT AND I BELIEVE
THAT THE OFFICE OF THE DIRECTOR
ASSUMES THAT THIS GROUP WILL
HAVE A STRATEGIC VISION AND MAKE
RECOMMENDATIONS AND THEN THE
NEXT STEP OF ALL OF THIS IS
RECRUITED AND AND THIS IS A
PLANNING PROCESS THAT WOULD
INVOLVE NOT ONLY MORE SPECIFIC
VIEWS OF HOW YOU WOULD
ACCOMPLISH SPECIFIC GOALS AND
REACH VISIONS BUT OBVIOUSLY
IMPLEMENTATIONS OF THAT.
NOT TO SAY THIS WON'T DO ANYBODY
ANY GOOD IF IT LOOKS LIKE WE'RE
ARGUING OVER THE FUTURE AND
CONTRIBUTING TO THE SAME
PROBLEM.
AND IT'S RELATIVE TO HAVING THAT
[INDISCERNIBLE]
>> YEAH.
>> I DO THINK THAT THIS BOARD
NEEDS TO MAKE A STATEMENT AND
ENCOURAGE US TO DO THAT.
THE BOARD FOR TEACHING VISION
AND SWIMMING UP STREAM SO LIKE I
CAN REMEMBER VERY, VERY WELL,
DOCTORS SAYING TO ME, WHAT ARE
YOU TALKING ABOUT.
YOU HAVE INFORMATION, PATIENTS
CAN'T UNDERSTAND THAT STUFF,
IT'S RIDICULOUS.
WELL I DON'T KNOW HOW MANY
PEOPLE WOULD SAY THAT BUT QUITE
A FEW STILL.
SO OUT REACH OF THE PUBLIC AND
NOT EVERYBODY DOES, IT'S--
>> ONE OF THE BIGGEST THINGS
THEY'VE DONE NOT ONLY FOR THIS
COUNTRY BUT FOR THE WHOLE WORLD,
I MEAN HAVING SERVED FORTUNATELY
ON THIS, FOR A GOOD 15 YEARS OR
MORE AND HAVING THE SUPPORT
STRUCTURE, THE CHAIR, THOSE YOU
ARE THE ONES THAT PUT THAT ON
THE TABLE.
HE WOULD NOT HAVE ANYTHING IN
THE AREA FOR THE TUMOR
INFORMATICS AND THE WHOLE THING
ON OUTREACH IN SO MANY WAYS,
EVEN THE PILL STUDY YOU JUST
TALKED ABOUT, THAT'S ALL
OUTREACH FOR THE PEOPLE OF THE
COUNTRY WHO ARE PAYING THE TAXES
WHO ARE GETTING SO MUCH THAT YOU
HAVE DONE TO DO THIS IS NOT AS
HARD OF THE MISSION AND
LIBRARIANS AND HELP AND MAYBE
NOT SO CRITICAL BUT I AGREE WITH
YOU, WE NEED MORE INDIVIDUALS TO
REALLY KNOW WHAT IS GOING ON
HERE, HOPEFULLY AT THAT MEETING
THAT YOU'RE GOING TO HAVE,
SHORTLYOT SECOND OF MARCH THAT
THESE THINGS WILL COME TO
FRUITION.
>> YEAH.
>> IT'S STRIKING TO SEE THAT WE
ON THE BOARD CAN GIVE THEM THAT
WOULD NOT BE GIVEN TO THE
COMMITTEE WOULD BE A GREAT JOB.
SO I WANT TO AGREE WITH YOU THE
IMPORTANCE OF US SAYING WHAT WE
BENEFITED FROM WHERE WE ARE.
>> I THINK IT'S ABSOLUTELY
CRITICAL THAT THE BOARD HAS
DECIDED TO DO THIS AND
[INDISCERNIBLE] THE PRIVILEGE OF
SITTING AND THE BOARD IS LOOKED
ON AS A VERY, VERY AUTHITATIVE
AND LEADER, AND WE HAVE AN
INTELLECTUAL TREASURE HERE, WE
HAVE THE STAFF OF THE LIBRARY
THAT COULD PROVIDE EXCELLENT
INPUT PROBABLY BY PROGRAMS AND
PROJECTS TO ADDRESS THE ISSUES
THAT YOU WANT TO PROMOTE AND
WHETHER YOU--HOWEVER YOU DO IT,
FORM THE SUBCOMMITTEE, I WOULD
ENCOURAGE YOU TO CHOOSE STAFF
THAT CAN GIVE YOU INPUT AND HELP
WRITE UP AND FORMULATE WHATEVER
YOU WANT TO FORMULATE.
>> WELL WE CERTAINLY WILL
PROVIDE SUPPORT TO THE BOARD IN
PUTTING TOGETHER
[INDISCERNIBLE].
>> SO ONE THING I'M CONCERNED
ABOUT IN THE OUTREACH IS THE
SCIENTIFIC COURT, MYTHOLOGICAL
CORE OF OUR FIELD THAT I FEEL IS
LESS--UNLESS THERE IS A--AS
INFORMATIC SYSTEM GETTING
APPLIED IN MOST OF THE ICs, IN
ONE FORM OR ANOTHER, THERE'S A
MYTHOLOGICAL COMPONENT OF A LOT
OF THESE AND THERE'S NOT A WAY
TO KIND OF PROVIDE A RESOURCE TO
ALL OF THOSE PROJECTS TO
IDENTIFY ROUTINES AND DEVELOPING
THE METHODOLOGIES TO SUPPORT
SUPPORT THEM SO SOMEHOW, THE
RULE OF NLM OR WHATEVER WILL
BECOME OF NLM TO CONTINUE THAT
AND STRENGTHEN THAT, WE'VE NOW
GOT VERY SMALL AMOUNTS OF GRAT
MONEY TO DO THAT KIND OF WORK
AND YET, THE INFORMATICS BUDGET
OVERALL THROUGHOUT NIH AND LOOK
AT ALL THE WAYS IT'S APPLIED IS
GROWING.
SO IT SEEMS LIKE WE'RE--WE'RE
LOSING THE OPPORTUNITY TO
INTEGRATE THE SCIENCE OF THIS
FIELD AND SOMEHOW THAT VOICE
NEEDS TO BE STATED.
THE PEOPLE THAT ARE
[INDISCERNIBLE] AND ELECT THEM
MIGHT WELL, PARTICULARLY I DON'T
KNOW WHAT THE POSITION IS ON
THAT, BUT OTHER THAN OTHER THAN
THAT AND THE VOICE YOU CAN BRING
TO IT, I'M NOT SURE WHERE IT
WILL BE ARTICULATED.
>> THE BOARD HAS ALWAYS ACTED
JUDICIOUSLY AT INFORMING THE
DIRECTOR AND NIH, AND I THINK
THAT IS VERY IMPORTANT THAT WE
COMPILE A VERY FORMAL AND
THOROUGH RESPONSE BUT THE BOARD
HAS ALSO BEEN THE CONDUIT OF THE
VARIOUS CONSITUENCES AND IT'S
IMPORTANT THAT THE INDIVIDUAL
MEMBERS OF THE BOARD AND THE
EXOFFICIO MEMBERS ALL REACH OUT
INTO THE CONSITUENCES AND THE
COUNCILS OF THE ORGANIZATIONS
THAT ARE IMPACTED TO ASK THOSE
COUNCILS AND OFFICERS AND THE
WHOLE ORGANIZATION WILL NOT BE
ABLE TO RESPOND IN THIS TIME
FRAME BUT THE OFFICERS CAN
RESPOND WITH A FORMAL REQUEST TO
PROVIDE INFORMATION IF IT'S
BROUGHT TO THEIR ATTENTION THAT
IS IMPORTANT, METHLOGICAL STUDY
BE PRESERVED THAT THE LIBRARY
NEEDS TO RESPOND, DISASTER
COMMUNITY, WE HAVE A NEW
INITIATIVE TO PROVIDE DISASTER
INFORMATION IN A TIMELY WAY.
WELL, ALL OF THESE VARIOUS
CONSTITUENCIES NEED TO BE ASKED
BY THE MEMBERS OF THE BOARD TO
RESPOND BECAUSE THAT'S THE OTHER
BOARD FUNCTION IS THE INTERFACE
AND OUTREACH AND WE'RE GOING TO
HAVE TO BE FAIRLY VIGOROUS OVER
THE NEXT MONTH TO SEE THAT THOSE
RESPONSES ARE CAREFULLY AND
THOROUGHLY PREPARED AND BROUGHT
TO THE ATTENTION OF THE ADVISORY
GROUP.
>> I THINK ONE OF THE THINGS I'M
HEARING IS THAT THE
RESPONSIBILITY OF THE BOARD IS
TO BE ABLE TO BRING UP A
STEWARTSHIP BALANCE TO THE
CONSTITUENCIES THAT ARE SERVED
BY NLM AND IT'S VERY COMPLIANT
AND YOU HAVE THE APPLICATIONS ON
THIS SIDE AND HOW DO WE MARRY
THE TWO AND THE BOARD IS ONE WAY
THAT WAS HAPPENING SO HOW DO WE
PRESERVE THAT TYPE OF MOVING
FORWARD, IDEAS AND PROVIDE THAT
INPUT FOR THE WORKING GROUP.
>> THIS WILL BE [INDISCERNIBLE]
BOARD PROVIDED--
>> IT WOULD BE IN TERMS OF THE
INFORMATION WHEN IT'S REQUESTED
BUT YES.
THE WORKING GROUP AND I ASK THEM
TO WHAT EXTENT THEY WENT ON IN
THE CONVERSATION AND TO THIS
GROUP, THE WORKING GROUP IS
THINKING VERY BROADLY ABOUT THE
ROLE OF INFORMATICS TRANSNIH AS
YOU MENTIONED AND HOW NLM
CURRENTLY FETTURE FIT INTO'S
THAT ROLE.
SO IT'S A BIG TIPPING POINT,
IT'S A REALLY BIG DEAL ACTUALLY,
FRANCIS I BELIEVE IS
[INDISCERNIBLE] I KNOW HE HAS
[INDISCERNIBLE] IT'S QUITE CLEAR
FROM THE WAY HE TALKS, BUT HE
HAS HIS OWN IDEAS AND WHETHER OR
NOT THE WORKING GROUP ENDS UP
READING WITH THOSE AND WHETHER
OR NOT, YOU DON'T KNOW YET
BECAUSE YOU HAVEN'T MET
[INDISCERNIBLE].
>> I WOULD NOTE THAT
[INDISCERNIBLE] SERIOUSLY, BUT I
WOULD LIKE TO KNOW WHAT HAPPENED
BACK IN 1980 WHEN IS YOU COULD
[INDISCERNIBLE].
WHAT WAS THE PROCESS THEN
[INDISCERNIBLE] IN TERMS OF ANY
USEFUL INFORMATION THAT WE MIGHT
BEAR IN MIND WITH RESPECT TO
THAT?
>> FRANKLY STRATEGICALLY ONE
THING I WANTED TO DO WAS TO
STEER NLM MUCH MORE INTO THE
HEART AND OPERATIONS OF NIH, I
MEAN IT WAS VERY STAY ASIDE?
I WOULD ALWAYS ALMOST SAY ARM'S
LENGTH AND I RECOGNIZING THAT IT
WAS DANGEROUS HAS IT HAS BEEN
AND I STILL THOUGHT IT WOULD BE
BETTER IF WE'RE REALLY HONESTLY
INTHEWSIASTICALLY PART OF NIH IN
EVERY WAY WE COULD BE.
BUT OF COURSE IT'S A TWO-WAY
STREET.
THAT IS WHAT I WAS SAYING AND IN
FACT IT'S TRUE IN THE TWO
BUILDINGS, IT'S TAKEN AN
ENORMOUS EFFORT TO GET
[INDISCERNIBLE] AND AUTHORITY
FOR EXTRAMURAL GRANTS AND THOSE
THINGS WERE DONE BY THE TIME I
CAME BUT I SENSED WHEN I WALKED
IN THE TUNNEL THAT THERE WOULD
BE A 2-FOOT HAWAII CAPS AND
RESEARCH THE REST OF YOU STAY
OUT.
[LAUGHTER]
I THOUGHT THAT'S TERRIBLE, CAN'T
AFFORD IT AT ALL AND THEY
INVOLVE THE LIBRARY PEOPLE AND
THE RESEARCH PEOPLE WORKING
TOGETHER FOR THE COMMON
OBJECTIVE AND SO MOST OF WHAT
WE'VE DONE HAS WORK THAD WAY.
THERE'S STILL A TUNNEL AND MORE
WINTER WEATHER USE
[INDISCERNIBLE].
[LAUGHTER]
THAT WAS SORT OF TWO ASPECTS FOR
THE EARLY DAYS FOR ME, BUT THE
OTHER PART WAS KIND OF FUN, I
FIGURED THAT I KNEW THERE WERE
ALL KINDS OF INJUNCTIONS THAT
STAY OUT OF THE CONGRESS BUT I
JUST DECIDED, YOU KNOW FOR THE
FIRST YEAR, YOU JUST FUMBLE
AROUND IT'LL BE OKAY.
AND I REMEMBER VISITING ONE
CONGRESS AND I WON'T SAY THE
NAME BUT IT'S THEN ARRANGED BY
FRIENDS AND SO, I WAS EAGER TO
TELL THEM ABOUT THE RESEARCH
DONE AT THE NATIONAL LIBRARY OF
MEDICINE AND AFTER 15 MINUTES,
THE GUY LOOKED AT ME AND HE SAID
OH, YOU'RE A FEDERAL AGENCY THEN
ARE YOU?
[LAUGHTER]
>> WELL ... [LAUGHTER]
>> SO [INDISCERNIBLE] NO I WAS
SURPRISED THERE WAS ONE, BUT WE
ALSO HAVE ONE OF THE PLANS.
I THINK THERE WAS A CONCERN
ABOUT THAT THAT LED TO YOUR
SELECTION IT WASN'T AN ACCIDENT
THAT YOU WERE CHOSEN.
YOU WOULDN'T HAVE BEEN NORMALLY
[INDISCERNIBLE] SUCCESS.
I MEAN THE GENERAL TREND OF
LIBRARIES YOU ARE SOMEWHAT
ATYPICAL.
>> YEAH.
>> YOU HAVE SERIOUS, SERIOUS
PROBLEMS IN THE LIBRARY, THE
EFFORTS TO CREATE SIMPLE
CATALOGS IN THE 60S AND WE'RE
LEADING TO HUGE AMOUNTS OF
INSTITUTIONS AROUND THE COUNTRY
WHERE I.T. PEOPLE WHO COULDN'T
SPELL LIBRARY AND LIBRARIAN WHO
IS COULDN'T COUNT WERE SITTING
IN THE SAME ROOM TRYING TO MAKE
A CATALOG÷wñ AND THERE WAS NO
CAREER UNDERSTANDING OF THE WAY
[INDISCERNIBLE] COULD BE USED
FOR INFORMATION AT THE SAME TIME
THE GOVERNMENT WAS IN THE RADIO
AND TELEVISION BUSINESS AND THE
TECHNOLOGY WAS MOVING FASTER
THAN THE GOVERNMENT COULD MOVE.
WHICH LED TO THE LISTER HILL
BEING BROUGHT UP UNDER THE
LIBRARY AND AN EFFORT TO GET AN
FASTER MOVERRING TECHNOLOGY SO
WHEN THEY LOOKED THEY SAID WE
NEED SOMEBODY INTERESTED IN
COMPUTERS AND INFORMATION, NOT
SOMEBODY WHO'S PRIMARILY
INTERESTED IN CONSERVING DATA.
AND I THINK THERE WAS A
DELIBERATE ATTEMPT AND THERE
THEY'RE TRYING TO FIGURE OUT
WHAT ARE THE ISSUES, WHAT ARE
THE PROBLEMS AND LOOK FOR
SOMEBODY TO LEAD THIS?
BECAUSE WHEN YOU GO BACK TO
DR. COLLINS CLOSED THE PUBLIC
CATALOG, A GOOD PART OF THE
STAFF HAD BLACK ARM BANDS ON.
>> ONLY A FEW FROM THE HISTORY
OF MEDICINE--[LAUGHTER]
I REMEMBER THIS VERY WELL
BECAUSE I WAS THE ONE THAT
ORGANIZED THE EVENT.
[LAUGHTER]
BUT I DIDN'T ORGANIZE THE BLACK
ARM BANDS.
>> NO.
>> WELL I THINK HE WAS PUT UP TO
IT BY P. R.
>> WOULDN'T SURPRISE ME.
BUT IT WAS A FRACTION IN THE 60S
AND 70S ON THE WAY FORWARD IN
THIS AND THE NEED FOR SOMEBODY
WHO WAS A SCHOLAR AND ACTIVELY
INVOLVED FOR THE VISION FOR THE
FUTURE IS WHAT THEY WENT LOOKING
FOR AND THEY FOUND.
SO I THINK THIS IS MUCH THE SAME
TIME, YOU KNOW?
THERE ARE SERIOUS METHOD LOGICAL
QUESTIONS, THERE ARE SERIOUS
QUESTIONS ABOUT OUTREACH, THERE
ARE LOTS OF THINGS THAT WE ARE
ENGAGE INDEED THAT ARE
CRITICALLY IMPORTANT.
I MEAN THIS WHOLE OUTREACH
BUSINESS, IF THE PUBLIC IS GOING
TO FUND BIOMEDICAL RESEARCH
GOING FORWARD, THEY'RE GOING TO
HAVE TO BE KNOWLEDGEABLE ABOUT
IT AND IT'S NOT SOMETHING NIH
CAN IGNORE AND IT'S JUST THE
DIRECTOR GOING UP AND PROMISING
REPRESENTATIVES WHO HAVE HEART
PROBLEMS WE'RE GOING TO SOLVE
HEART ATTACKS, TELL TAKE MORE
THAN THAT TO GET FUNDING FOR
BIOMEDICAL SCIENCE GOING
FORWARD.
TELL TAKE ENGAGEMENT TO COVER IT
AND WE NEED STRONGLY TO MAKE
THAT CASE.
>> WE NEED TO [INDISCERNIBLE]
THE BOARD AND THE COMMITTEE AND
HAVE THE BOARD SAY THIS IS THE
WAY TO THE FUTURE AND IT NEEDS
TO BE COMPELLING FOR THE
COMMITTEE TO ACCEPT THIS PART
[INDISCERNIBLE] AND PART OF WHAT
THEY WANT [INDISCERNIBLE].
>> AND I THINK THAT FROM ALL I
HAVE HEARD AND SEEN,
DR. COLLINS AND THE WORKING
GROUP AND THE COMMITTEE IS
WORKING WELL AND ADVISING THE
BOARDS ON THIS SO MY FEEL
SUGGEST I AGREE WITH DALE THAT
IT WILL BE VERY HELPFUL FOR THE
REQUEST FOR INFORMATION PROVIDED
BUT MY--MY VIEW IS THAT THE
BOARD CAN PUT THEIR INPUT
TOGETHER IN ANY WAY THEY WISH.
I MEAN IF THEY LOOK AT THESE ARE
THE FIVE QUESTIONS THEY ASKED
BUT WHAT WE REALLY WANT TO TALK
ABOUT IS ABCD.
>> [INDISCERNIBLE].
>> AND CAN SUBMIT IT, YEAH.
>> BUT THEY'RE NOT MUTUALLY
EXCLUSIVE.
>> NO, NO, THEY'RE NOT, BOTH,
BOTH, BOTH.
>> SO WE HAD ABOUT
A-[INDISCERNIBLE]
>> SO TRYING TO COME UP WITH A
STRATEGIC PLAN IS A VISION,
YEAH, SO WILL SOMEONE BE THE
EDITOR OF THAT AND I
GUESS--[INDISCERNIBLE], WORK
TOGETHER ON THIS,.
>> WILL PROVIDE SUPPORT.
>> BECAUSE WE NEED TO MAKE THIS
PRECISELY.
>> I THINK THE BEST WAY OF
ORGANIZING [INDISCERNIBLE].
>> PREMIUM ADDING AND THERE'S
NOT A LOT OF TIME TO PUT
TOGETHER, SO THE ISSUE IS SO
THERE'S TIME TO PUT ON THIS IN A
MATTER OF WEEKS SO YOU ALL CAN
THINK ABOUT THAT AND LET ME KNOW
QUICKLY.
>> BUT JUST THINKING IN THE
FUTURE WE'RE IN A WORLD SOONER
THAN WE IMAGINED AND EVERYTHING
IN THE PLANET WILL BE SEQUENCED.
HOW DO WE INTERPRET THIS.
SO I THINK THERE'S
INTERPRETATION, WHICH IS MORE
TECHNICAL EXECUTION AND THERE'S
ALSO EDUCATION.
I MEAN DATA ARE NOT CERTAIN.
HOW DO WE EDUCATE THE PUBLIC AND
OUR STUDENTS TO COPE WITH
UNCERTAINTY.
>> [INDISCERNIBLE] KEEP
DISCOVERING NEW MECHANISMS.
>> WELL I I'LL SPEAK OFFLINE
ABOUT THIS BUT WHAT I'M LEARNING
AS MORE AND MORE DATA BECOME
AVAILABLE IS HOW COMPLICATED
MOTHER NATURE IS AND HOW
UNCERTAIN WE ACTUALLY ARE; YOU
KNOW?
>> I'M WONDERING IF PEOPLE MIGHT
HAVE FLEXIBILITY IN THEIR TRAVEL
SCHEDULES AND HAVE THOSE THAT
ARE INTERESTED COME TOGETHER
TOMORROW, I DON'T KNOW IF THAT
WILL WORK OR NOT THAT'S A
POSSIBILITY.
>> WELL WHAT WE CAN DO IS
ORGANIZE OURSELVES TO HAVE THAT
MEETING AND ANYONE WHO CAN, CAN
PARTICIPATE AND WILL BE DEALING
WITH, YOU KNOW HAVE FOLKS WHO
ARE PROBABLY [INDISCERNIBLE]
FROM OUR PLANNING ACTIVITY AND
THE ACTIVITY RANGE SO WE CAN GET
GOING ON THIS, THE OTHER THING
OF COURSE IS TO LOOK AT IS AND
MAYBE A PLACE FOR PEOPLE TO
THINK AND START, IS SOMETHING
THAT WAS ALSO COMMUNICATED FOR
THE WORKING GROUP.
AS YOU MAY REMEMBER, THE CURRENT
PLAN AND YOU KNOW I CAN PROVIDE
POINTERS FOR EVERYBODY, THE
CURRENT PLAN INCLUDED A 20 YEAR
STRATEGIC VISION AND THEN A 10
YEAR PLAN.
SO WE COULD LOOK AT THE 20 YEAR
VISION AND THINK IT'S NOT GREAT
OR THE BOARD DID A WONDERFUL JOB
PUTTING IT TOGETHER, BUT I HAD
OCCASION TO REVIEW IT RECENTLY
AND IT--YOU KNOW THERE'S A LOT
IN IT THAT IS STILL OF INTEREST
AND HAS BEEN ACCOMPLISHED AND
IMPROVED.
SO, YOU KNOW I'M NOT
SUGGESTING--I'M JUST--I DON'T
THINK WE WANT TO REITERATE IT.
WE WOULDN'T WANT TO REITERATE IT
AND WE MIGHT SORT OF GET YOU
THINKING ABOUT WAYS OF PUTTING
SOMETHING TOGETHER.
>> CAN YOU SEND THAT AROUND.
>> I CAN.
>> IF YOU GIVE--IF YOU SEND FOR
THE URLPORTION FOR THAT, YOU
GIVE IT OUT [INDISCERNIBLE].
>> ALL THE MAJOR, PLACED MANY OF
THE MAJOR DECISIONS WERE MADE AT
THIS STABLE BY THE BOARD, SO
THIS CRAZY IDEA OF PUTTING
ANATOMICALLY STUFF OR THE FALL
OUT WAS AN IDEA THE CRAZY IDEA
ABOUT GIVING INFORMATION TO THE
PUBLIC WAS A BIG DAMN DEAL, IT
BUT THE DECISION WAS TAKEN BY
THIS BOARD.
>> AND THE CREATION OF NCBI,.
>> CREATION OF NCBI, SO WHAT
WERE THOSE MAJOR STEPS, THERE
WERE BT TOO MANY BUT SO WHAT
WILL HAPPEN IN THE FUTURE.
SO FOR EXAMPLE, AT THE MOMENT
THERE ARE NO CLASSIFIED DATA IN
ANY PLACE IN NLM.
WELL, I WOULD VOTE IN FAVOR OF
HOLDING THAT LINE BUT YOU KNOW
IT MAY CHANGE, BY AND LARGE
THERE'S NO INDIVIDUAL PATIENT
DATA BUT THE EXCEPTION IS THESE
PERSPECTIVE STUDIES THAT NIH'S
DONE AND CAREFULLY RUN BY AGAIN
AND NCBI.
BUT THERE'S A MAJOR MOVE TOWARD
OPENING ALL THAT UP THAT WOULD
BE A DECISION NOT JUST MADE BY
NLM BUT WE'RE ALSO PART OF NIH,
AND HHS, AND THAT'S TOO, IT MAY
FEEL LIKE H. E. W. BUT SOME OF
THOSE MAJOR QUESTIONS ARE
SOMETHING THE BOARDS ARE GOING
TO HAVE TO TAKE A MAJOR POSITION
ON.
HOW MUCH OF WHAT WE SO, I COULD
IMAGINE A TIME WHEN MOST OF THE
VISION.
>> ANOTHER THING THEY SAID WAS
ON THE BOARD AND YOU WERE MAKING
COMMENT--
>> NO I THINK :5THE BOARD'S
BEEN
WONDERFUL WE KEEP THINKING WHERE
IS THE MASON-DIXON LINE.
I REMEMBER THEY SAID, WAIT A
MINUTE, HAVE YOU TOO MANY
SOUTHERNERS.
TOO MANY SOUTHERNERS?
SHIFT THEM AROUND AND ONCE I
NOMINATED A DISTINGUISHED GUY
FROM NEW YORK CITY AND HE GOT
SENT BACK BECAUSE WELL, THERE'S
TOO MANY PEOPLE FROM NEW YORK,
SO I CALLED AND I SAID I HAVE TO
CANCEL YOUR APPOINTMENT AND HE
SAID HOW COULD YOU HAVE TOO MANY
PEOPLE FROM NEW YORK?
[LAUGHTER]
SO WE ALL AGREE THAT SHOULD
SHOULD BE GOOD POINT BUT--
>> THE AMAZING THING IS WHEN YOU
CAME WITHIN A YEAR OR TWO, THE
FIVE REPORTS FOR THE LONG RANGE
PLANNING IN THE BASIS OF THE
85-86, 27, AND LIKE THAT, AND
THERE WAS ONLY ONE OR THE OTHER
IDEAS.
>> BUT AS FAR AS BOARDS, SOME
ARE IN THE WHITE HOUSE DIRECTLY.
THEY ALL WERE IN THE OLD DAYS,
SO WE'VE HAD TO ADOPT IT BUT SO
BY AND LARGE IT WOULD BE THREE
SLOTS AND MAKE ONE SO IS IT
TERRIBLE TO HAVE SOMEBODY WHO IS
REALLY DIRECT, PERSONAL
CONNECTIONS WITH THE
WHITE HOUSE.
>> OR ARE WE THE MEMBER OF
CONGRESS?
>> NO, IT'S NOT, NOT.
>> I COULD SEE A BIG ADVANTAGE
ONE OF THE FIRST MEETINGS I
ATTENDED, I DON'T KNOW--I WAS
OVER THERE WITH THE LINE OF
TELEPHONES AND THE NEW MEMBER OF
THE BOARD IS IN RIGHT NEXT TO ME
AND DIAL THE WHITE HOUSE AND
THEY SAID I'M SO AND O, GIVE ME
CAP WINE BERGER AND I SAID HOW
FAR WILL THIS GO.
THEY DID GIVE IT ALL.
>> I THOUGHT, WELL, THAT'S THAT
GUY BUT UNFORTUNATELY, THE FIRST
QUESTION HE RAISED TO THE BOARD
WAS, WHY ARE YOU PUTTING
COMPUTERS IN LIBRARIES?
AND WE THOUGHT, WELL WE HAVE A
LITTLE WORK TO DO.
>> [LAUGHTER]
>> AND BEFORE HE LEFT THE BOARD,
HE WAS SAYING, YOU'RE NOT
PUTTING ENOUGH COMPUTERS!
[LAUGHTER]
>> SO WE RAISE THE QUESTION
ABOUT THE BOARD, THERE'S BEEN
FUN INTERNATIONS AND WE'VE
GOTTEN WONDERFUL PEOPLE.
>> OF COURSE THE DIVERSITY OF
PEOPLE AROUND THE BOARD IS A
FUNCTION OF THE CURRENT NLM
AUTHORIZATION, THE PART THAT
SPECIFIES WHO ARE THE
REPRESENTEDOT BOARD MIGHT HAVE
BEEN--IT WAS ALSO A DIVERSE
GROUP OF PEOPLE, MIGHT HAVE BEEN
AMENDED ONCE TO EXPAND EVEN A
COUPLE TIMES TO EXPAND EVEN
MORE.
BUT IT'S REALLY A REQUIREMENT
FOR THIS TO BE A
MULTIDISCIPLINARY BOARD.
>> I THINK WE WROTE IN
[INDISCERNIBLE], IT SHOULD BE.
>> I FOUND THE BOARD TO BE A
GREAT, GREAT INSTALLATION, AND
WONDERFUL, EVERY SINGLE MEETING
IS WITH MORE.
>> OKAY, SO WHERE WE ARE, THEN,
IS PEOPLE WILL THINK HARD ABOUT
WHETHER THEY WANT TO BE ON THE
SUBCOMMITTEE, WE WILL DISTRIBUTE
HARD COPIES OF THE VISION IN
TERMS OF THE PLAN, WE WILL ALSO
SEND A ROUND E-MAIL POINTER TO
IT AND PEOPLE WHO WANT TO
DIRECTLY ADDRESS THIS QUESTION
OR TALK MORE ABOUT THIS, AND ARE
ABLE SAY FOR NOW OR AFTER THE
MEETING TOMORROW, WILL DO THAT
AS WELL.
>> [INDISCERNIBLE] BUT I WOULD
LIKE TO SEE WHAT PEOPLE
[INDISCERNIBLE] MAJOR
ACCOMPLISHMENT AND THE REASON I
WANT TO SEE THAT IS I THINK
THOSE OF US HERE IT'S SO EASY TO
FORGET AND --NMOSTLY THAT
RESOLUTION WE ADOPTED.
>> [LAUGHTER]
>> [INDISCERNIBLE].
>> THERE WERE A FEW THINGS TO
THINK ABOUT, LARGER QUESTIONS IN
THE LIBRARY WORLD PEOPLE ARE
GETTING INSULT WIDE THE
SIMPLISTIC QUESTION, WHY DO YOU
STILL EXIST?
EVERYTHING'S FOR FREE ON THE
INTERNET?
WELL THINK ABOUT WHAT THIS
INSTITUTION REPRESENTS IS YOU
FOLKS HAVE PASSED THAT QUESTION
IS IN THE PASS.
REAR VIEW MIRROR FOR NLM WHAT
YOU'RE CALLING OUT REACH IS
REALLY WEIGHING OUT A NUMBER OF
SERVICES THAT NO ONE WOULD HAVE
THOUGHT 20 YEARS AGO.
SO IT'S IMPORTANT TO BRING THAT
BACK, WHAT YOU'RE DOING AND YOUR
CUSTOMERS OR STAKEHOLDERS WHAT
THEY'RE OUT THERE LEADING TO IT
IF THAT'S A KEY THING.
>> I AGREE THE BIGGEST THREAT TO
PEOPLE, IS THAT INTELLIGENCE
MOTIVATED PEOPLE THINK THAT
EVERYTHING'S IN THE COMPUTER SO
WE DON'T NEED LIBRARIES OR
LIBRARIANS.
>> THEY ALL GO IN THE COMPUTER.
>> YEAH.
>> IT'S INTERESTING WHEN DON
CAME TO NLM, I HAD BEEN HERE FOR
11 YEARS AND MANY OF US WORKING
HERE FELT THAT WE WERE REALLY
WORKING TO MAKE INFORMATION
AVAILABLE, YOU KNOW, TO THE
WORLD AND WE WERE AND WE FELT
THAT WE WERE REALLY IN TUNE WITH
CUSTOMERS WHICH ARE--YOU KNOW WE
DIDN'T CALL THEM THAT, USERS AND
OF COURSE WE KNEW AT THE TIME WE
FELT GIVEN THE NATURE OF OUR
SYSTEMS THAT THE WAY WE WOULD
REACH THE PHYSICIANS AND THE
PATIENTS WAS THROUGH--AND OTHER
HEALTH PROFESSIONALS WOULD BE
LIBRARIES AND WE THOUGHT WE WERE
GREAT, BUT ONE OF THE THINGS I
REALLY REMEMBER ABOUT DON IS
THAT HE CAME AND HE HAD A USER
PERSPECTIVE, HE HAD A USER
PERSPECTIVE WHICH WE DIDN'T
HAVE.
AND ONE OF THE FIRST THINGS HE
DID WAS DECIDE THAT IT WASN'T
REASONABLE FOR US TO BRING IT
DOWN AT 6:00 P.M. EASTERN
STANDARD TIME BUT IN FACT,
PEOPLE IN CALIFORNIA SO WE COULD
DO PROCESSING AND INTERNAL
STEPS.
THE PEOPLE IN CALIFORNIA, MIGHT
HAVE A RESEARCH OR CLINICAL
QUESTION AFTER 3:00 P.M. IN THE
AFTERNOON LET ALONE THE POOR
PEOPLE IN HAWAII WOULD HAVE TO
GET UP EARLY, TO DO A SEARCH SO
AND SAID WE'RE GOING TO CHANGE
THIS AND THEY'RE NOT ACCEPTABLE
AND THERE WERE 19 REASON YES IT
COULDN'T BE DONE.
>> SO I JUST ENCOURAGE PEOPLE TO
REALLY THINK BROADLY AND TRULY
BE [INDISCERNIBLE] ROLL OF
LIBRARY [INDISCERNIBLE].
ARE THERE ANY OTHER QUESTIONS?
>> HOW ARE THEY OVERARCHING
REACHING LIBRARIES?
>> A NATIONAL NETWORK OFFICE HAS
BEEN IN NLM AND--SO,.
>> COMPETITION FOR THE REGIONAL
MEDICAL LIBRARIES AND THEN
THERE'S OVER ALL [INDISCERNIBLE]
>> SO JUST AS THE BOARD IS GOING
TO PUT TOGETHER A STATEMENT, I
THINK IT WOULD BE POWERFUL FOR
THE REGIONAL LIBRARIES TO GET
TOGETHER AND PUT A STATEMENT
TOGETHER.
I DONE KNOW HOW TO ORGANIZE THAT
BUT SOMEBODY SAID.
>> YEAH IT COULD PROBABLY BE
ORGANIZED.
>> [INDISCERNIBLE].
>> THAT COULD BE DONE.
>> I WAS HELPING YOU OUT.
>> [INDISCERNIBLE]
>> THERE'S NO MEDICAL
INFORMATICS [INDISCERNIBLE] FOR
20 YEARS AND IT'S
[INDISCERNIBLE] FROM MY
PERSPECTIVE IT'S REALISTIC
PRIVATE THAT HAD A HUGE EFFECT
AND YOU KNOW CAME OUT OUT AND
VOCABULARY AND [INDISCERNIBLE]
AND STANDARD THAT MAYBE I'VE
THOUGHT OF THAT AND ALL THE SAME
THINGS AND FOR THEM TO GET LOST
IN THE HIGH LEVEL OF THINKING.
AND IT'S JUST DRASTIC.
>> WELL, I THINK THAT THAT'S
ANOTHER ISSUE, PEOPLE PROVIDING
INPUT WHO UNDERSTAND THAT THAT'S
FOR THEM IS ONE OF THE
IMPORTANT--VERY IMPORTANT
SERVICES AND ASPECTS OF THE
LIBRARY.
>> [INDISCERNIBLE] IS VERY GOOD.
WE WOULD NEVER HAVE INFORMATIC
SPECIALTY IF IT HADN'T STARTED
WITH THE SUPPORT FOR THE
NATIONAL LIBRARIES AND THAT JUST
HAD TO [INDISCERNIBLE].
>> WELL IT STARTED OUT COMPUTERS
FIRST.
>> SO IF ANYONE IS HAVING
DISCUSSIONS I WILL STAY LATER?
>> YES.
>> AND ANYONE THAT CAN, IF YOU
CAN, IF YOU CAN'T THAT'S FINE
AND IT WILL BE IN TOUCH VIA
E-MAIL BUT I THINK EVERYBODY'S
INCLUDING IF YOU DON'T WANT TO
BE ON THE SUBCOMMITTEE, JUST
FIRE IT OFF TO BETTS SCHEWE'LL
MAKE SURE THAT THE POINTS ARE
CAST LONG AND WE CAN TRY AND
MAKE A COACH'S CASE FOR THE
WORKING GROUP WHO WILL VERY,
VERY SERIOUSLY PARTICIPATE IN
THIS.
THANK YOU VERY MUCH.
>> OKAY, SO TO MOVE ON WE HAVE A
GUEST SPEAKER DR. CATHY HUDSON.
SHE OVERSEES POLICY LEGISLATION
AND COMMUNICATION EFFORTS OF THE
NIH AND SENIOR ADVISOR TO THE
NIH DIRECTOR.
SHE WORKS ON SCIENTIFIC
INITIATIVES FOR NIH, SHE WAS THE
KEY ARCHITECT OF THE NATIONAL
CENTER KD--SALLY TRANSLATIONAL
SCIENCES AND THE NIH BRAIN
INITIATIVE AND DIRECT POLICY
DEVELOPMENT RELATED TO CLINICAL
TRIALS AMONG MANY OTHER
IMPORTANT ISSUES.
SHE JOINED NIH IN 2009 AND PRIOR
TO THAT SHE WAS THE FOUNDER AND
DIRECTOR OF GENETIC AND PUBLIC
POLICY CENTER AT JOHNS HOPKINS
UNIVERSITY AND THE ASSOCIATE
PROFESSOR OF BIOETHICS INSTITUTE
GENETIC MEDICINE AND DEPARTMENT
OF [INDISCERNIBLE].
SHE PREVIOUSLY SERVED AS
ASSISTANT DIRECTOR OF POLICY
COORDINATION IN WHAT WAS THEN
THE NATIONAL CENTER FOR HUMAN
GENOME RESEARCH AT NIH AND HELD
PRIOR POSITIONS AT THE POLICY
ANALYST AND THE OFFICE OF THE
ASSISTANT SECRETARY, HHS AND THE
CONGRESSIONAL OFFICE OF
TECHNOLOGY ASSESSMENT.
DR. HUDSON IS HERED TO TO TALK
ABOUT KEY NIH STRATEGE AND I CAN
POLICY INITIATIVES.
SO CATH KATHY, WELCOME.
>> SO I DO HAVE SLIDES.
THANK YOU FOR INVITING ME TODAY
TO JOIN YOU.
I WILL TALK ABOUT POLICY,
PRIORITIES AND CLINICAL RESEARCH
AND I KNOW THAT AFTER LUNCH,
JERRY IS GOING TO TALK TO YOU IN
MORE DEPTH ABOUT THE CLINICAL
TRIALS SO I'LL BE A VOICE FOR
HIM SO I WILL TALK ABOUT
CLINICAL TRIALS AND DATA SHARING
AND A PROPOSED POLICY THAT WE
HAVE RECENTLY PUT FORWARD
ENCOURAGING THE USE OF A SINGLE
INSTITUTIONAL REVIEW BOARD FOR
CLINICAL TRIALS THAT ARE
CONDUCTED AT MULTIPLE SITES.
SO AS YOU MAY KNOW CLINICAL
TRIALS RESEARCH REPRESENTS A
SIGNIFICANT ALTHOUGH NOT BY ANY
MEANS A MAJORITY OF RESEARCH
THAT WE SUPPORT ONLY ABOUT 12%
OF OUR TOTAL BUDGET.
WE CERTAINLY ALL APPRECIATE AND
CERTAINLY YOU AS THE BOARD HERE
FOR THE NATIONAL LIBRARY OF
MEDICINE APPRECIATE THE VALUE OF
SERING DATA OF ALL SORTS AND
CERTAINLY SHARE POINTS IN ORD
WHAT RESEARCH WE SHOULD SUPPORT
AND NOT SUPPORT AND AVOIDING
BIAS IN WHAT'S OUT THERE DUE TO
PUBLICATIONS SO RELUCTANCE OF
SOME JOURNALS TO PUBLISH
NEGATIVE RESULTS AND PREVENT
DUPLICATION OF UNSAFE TRIALS AND
IMPORTANTLY TO MEET THE ETHICAL
OBLIGATIONS TO PARTICIPATION IN
CLINICAL TRIALS THAT THEY ARE
UNLIKELY TO BENEFIT FROM THEIR
PARTICIPATION AND THAT OTHERS
WILL BENEFIT FROM THE KNOWLEDGE
GAINED AND IF THOSE RESULTS ARE
NOT MADE PUBLIC AND DISTRIBUTED
AND DISSEMINATED THANE WE'RE NOT
MAKING GOOD ON THAT COMMENT.
SO AS YOU'RE ALSO AWARE, THERE
IS A VERY POOR PUBLICATION TRACK
RECORD AND POOR PUBLICATION OF
RESULTS IN CLINICAL TRIALS.GOV,
SO THIS IS A STUDY FROM THAT
COLLEAGUES IN THE BRITISH
MEDICAL JOURNAL A COUPLE OF
YEARS AGO IN WHICH YOU SEE THAT
MANY, MANY MONTHS AFTER TRIALS
ARE COMPLETED, A SUBSTANTIAL
NUMBER STILL HAVE NOT PUBLISHED
THEIR RESULTS.
AND SIMILARLY, IN TERMS OF
POSTING RESULTS, RESULTS IN
CLINICAL TRIALS.GOV.
YOU SEE A SIMILAR FAILURE TO PUT
DATA IN THE CLINICALTRIALS.GOV.
AND IT VARIES BY SHAH BY PHASE
OF TRIAL AND WE ALSO SEE THAT IN
TERMS OF PUBLICATION THAT
THERE'S HIGHER LIKELIHOOD OF
PUBLICATION THAT THE OUTCOME OF
THE CLINICAL TRIAL RATHER THAN
THE THIRD THAT MEASURE, SO
THERE'S CORRELATIONS THAT CAN BE
MADE BUT NONETHELESS, WHAT WE
CAN DO IS GET THE NUMBER OUT UP
TO A HUNDRED--SO TO SUPPORT
THANKSGIVING AND WE PUBLISHED
AFTER MANY, MANY, MANY YEARS OF
TRIALS AND TRIBULATIONS A NOTICE
OF PROPOSED RULE MAKING ON DATA
REPORTING FROM CLINICAL TRIALS
AND INTO CLINICALTRIALS.GOV.
DR. COLLINS AND MYSELF PUBLISHED
AN ARTICLE IN JAMA AT THE TIME
AND THERE WAS A JOURNAL ABOUT
THREE WEEKS LATER AND GOING INTO
MORE DETAIL BY POSTS HERE AT THE
NATIONAL LIBRARY OF MEDICINE.
SO IT GOES TO PRIVATELY FUNDED
AND SUPPORTED TRIALS AND IT
INCLUDES, SENTIALLY EVERYTHING
THAT FDA, TRIALS WITH ANY FDA
REGULATED PRODUCTS WHETHER IT'S
A BROAD DEVICE OR BIOLOGIC T.
REQUIRES TRIALS, REGISTRATIONS
WITHIN 21 DAYS OF ENROLLMENT AND
REQUIRES SUBMITTING AGGREGATE
TRIAL RESULTS AND MAYBE AT THE
END I'LL TALK ABOUT MORE RECENT
RECOMMENDATIONS FROM AN IOM
REPORT TALKING ABOUT SUBMISSIONS
AND DATA SHARING FROM INDIVIDUAL
PATIENT LEVEL TRIALS.
WE'RE TALKING ABOUT AGGREGATE
ASSOCIATES.
SO THERE ARE ENFORCEMENT
PROVISIONS AND THE WAY THE
ENFORCEMENT PROVISIONS ARE
WRITTEN IN THE LAW IS THAT IF
YOU FAILED TO COMPLY AS A
GRANTEE AND OF COURSE GRANTEES
ARE INSTITUTIONS NOT
INVESTIGATORS, FUNDING FROM
FEDERAL SPONSORS SHOULD
[INDISCERNIBLE] SO THAT IS
ACTUALLY A VERY LARGE
[INDISCERNIBLE].
THERE'S ALSO FDA, SIMPLE
MONITORETTORY PENALTIES UP TO
$10,000 PER DAY PER OFFENSE.
SO WHAT WE WILL NEED TO DO AS WE
MOVE FORWARD AND RULES BECOME
FINAL IS THAT WE WILL NEED TO
VERIFY HERE AT THE NATIONAL
LIBRARY OF MEDICINE WITH A
TALENTED TEAM THAT HAVE YOU,
VERIFY THAT SUBMISSION OF
INFORMATION IS UP TO SPEED AND
THEN WE'LL NEED TO BE ABLE TO
COMMUNICATE THAT TO THE
APPROPRIATE FUNDER WHETHER THAT
BE NIH INSTITUTES AND CENTERS,
OR OTHER GOVERNMENT SUPPORTED
RESEARCHERS.
>> WE ARE IN THE PROCESS OF
DEVELOPING MECHANISMS TO NOTIFY
BOTH INSTITUTIONS AND
INVESTIGATORS OF SUSPICIONS OF
NONCOMPLIANCE AND THEN BE ABLE
TO WORK WITH INSTITUTIONS AND
INVESTIGATORS IN ORDER TO BRING
THEM INTO COMPLIANCE AND
SOMETIMES THAT'S GOOD, AND WE
HAVE A RELATIVELY GOOD TRACK
RECORD BUT WHEN YOU FIND FOLK
WHO IS ARE CHRONICALLY OUT OF
COMPLIANCE, IT GETS QUITE
DIFFICULT AND THAT'S WHEN THE
FIXES COME INTO PLAY.
THERE ARE TRIALS THAT ARE NOT
COVERED UNDER THE LAW IN
PARTICULAR PHASE ONE TRIALS ARE
NOT COVERED.
AND THAT WAS LARGELY BECAUSE
THAT INFORMATION WAS NOT
AVAILABLE AND VIEWABLE, SMALL
DEVICE STUDIES WHICH ARE PHASE
ONE ARE NOT INCLUDED.
OTHER VARIOUS SORTS OF TRIALS
ARE NOT INCLUDED.
IMPORTANTLY TRIALS OF
INTERVENTIONS THAT ARE NOT OF
FDA REGULATED PRODUCTS ARE NOT
COVERED AND OBSERVATIONAL
STUDIES ARE NOT COVERED AND
PROBABLY IN THE LATTER DARES OF
PUTTING TOGETHER THIS REGULATION
WE THOUGHT ABOUT THE MOTIVATION
HERE AND THE MOTIVATION IS THAT
DISSEMINATION OF CLINICAL TRIALS
RESULT FIST IT'S A GOOD IDEA AND
FOR SOME IT'S THE LAW.
SO DR. COLLINS OPTED TO EXTEND
THE POLICY TO APPLY TO ALL NIH
FUNDED CLINICAL TRIALS
IRRESPECTIVE OF PHASE AND
IRRESPECTIVE OF WHETHER THEY
WERE OF AN FDA REGULATED
PRODUCT.
SO IF YOU LOOK AT THE NUMBER OF
TRIALS THAT FALL INTO THESE
VARIOUS CATEGORIES AND THIS IS
AN ESTIMATE.
SO THE TOTAL NUMBER OF TRIALS
THAT ARE SUBJECT--THERE'S
ANOTHER DIFFERENCE I SHOULD HAVE
MADE.
THE LAW REQUIRES THAT WE REQUIRE
SUBMISSION FROM TRIALS OF
APPROVED PRODUCTS TO EXPAND THAT
TO UNAPPROVED PRODUCTS SO
LEARNLY IT'S LOOKING FOR
PRODUCTS THAT ARE OUT ON THE
MARKET BUT PERHAPS IT WOULD BE
NICE TO KNOW WHAT HAPPENED TO
THOSE PRODUCTS THAT DIDN'T MAKE
IT ON THE MARKET AND WHETHER
THERE WERE SAFETY OR EFFICACY
CONCERNS THAT WOULD BE IMPORTANT
FOR THE COMMUNITY OF SCIENTISTS
TO KNOW IN TERMS OF MOVING
FORWARD AND OTHER AREAS OF
CLINICAL RESEARCH.
AND WE DID OPT TO EXERCISE THAT
OPTION AS IT WERE AND THAT
BRINGS INTO UNDER THIS
REGULATION A SUBSTANTIAL NUMBER
OF ADDITIONAL TRIALS OF 7400
ANNUALLY.
AND THEN THERE ARE THE CLINICAL
TRIALS THAT ARE NOT ACT AND
APPROVED PRODUCTS AND THAT WOULD
BE
PHASE ONE AND TRIALS THAT ARE
OTHER MEDICAL INTERVENTION
PRODUCTS AND YOU CAN SEE THERE
ARE SOME THAT ARE NIH SUPPORTED
AND THOSE WILL BE COVERED BY OUR
NEW POLICY.
>> WE DID SAY THIS WOULD BE
TRIALS IRRESPECTIVE OF DAYS AND
INTERVENTION AND THE DATA
ELEMENTS WILL BE IDENTICAL AND
WE PUT THEM BOTH OUT FOR PUBLIC
COMMENT AT THE SAME TIME AND
WE'RE ANTICIPATING THAT WE WILL
BE ABLE TO RESPOND TO THE
COMMENTS AND BOTH THE NPRM AND
THE DRAFT NIH POLICY AT THE SAME
TIME AND IN AN IDENTICAL AND
CONSISTENT WAY.
SO THERE'S PROPOSED NIH DRAFT
MAKING AT THE SAME TIME AND THE
COMMENT PERIOD TECHNICALLY ENDS
WHEN JERRY?
>> I KNOWLEDGE END OF FEBRUARY,
IT HASN'T BEEN PUBLISHED YET BUT
THEY SAID [INDISCERNIBLE]
>> IT'S UNFORTUNATE THAT IT TOOK
SO LONG FOR THEM TO PROCESS THAT
REQUEST BECAUSE WE HAD A NUMBER
OF ORGANIZATIONS THAT
INDIVIDUALS HAVE THE COMMENT
PERIOD, THE PROPOSED RULES
BECAUSE IT GOES INTO GREAT
DETAIL ABOUT THE SPECIFIC DATA
ELEMENTS THAT HAVE TO BE
SUBMITTED IS QUITE VOLUME NOWS
AND FOR AN ORGANIZATION TO
REVIEW THAT CAREFULLY AND
RESPOND THOUGHTFULLY, OBVIOUSLY
WILL BE TAKING PEOPLE A BIT MORE
TIME THAN ORIGINALLY
ANTICIPATED.
SO AS I MENTIONED WE WILL TAKE
THOSE RULES INTO ACCOUNT AND WE
WILL PUT OUT A COMMENT FAIRLY
EXPEDITIOUSLY AND AT THE SAME
TIME WE'RE THINKING DEEPLY ABOUT
OTHER AREAS OF DATA SHARING AND
MAYBE HAVE YOU HEARD FROM US
THAT THE ASSOCIATE DIRECTOR FOR
DATA SCIENCE PHIL BOURN IS
THINKING CAREFULLY ABOUT HOW WE
CAN ENCOURAGE AND PROVIDE
OPPORTUNITIES FOR DATA SHARING
ACROSS THE BOARD, NOT JUST IN
CLINICAL TRIALS.
BUT THE IOM DID RELEASE A REPORT
FOR CLINICAL STRATEGIES AND
THEY'RE TALKING ABOUT INDIVIDUAL
LEVEL DATA AND THERE HAVE BEEN A
NUMBER OF COMPANIES WHO HAVE
ADOPTED THIS AS POLICY.
THERE ARE RULES AND OTHER
COUNTRIES TO ADOPT SUCH A POLICY
AND THE IOM MADE RECOMMENDATIONS
THAT PARTICIPANT LEVEL DATA BE
AVAILABLE AND THEY MADE SOME
VERY THOUGHTFUL AND IF YOU
HAVEN'T LOOKED AT THIS REPORT, I
COMMEND IT TO YOU.
WE ARE AT THE BEGINNING--VERY
BEGINNING PART OF STARTING TO
PHASE THROUGH THIS, A FAIRLY
COMPLICATED MATTER, BOTH IN
ORDER TO MAKE SURE THAT PEOPLE
DON'T USE SUCH DATAx IN
APPROPRIATE AND WAYS AND AND
[INDISCERNIBLE].
WE ARE ALSO MOVING FORWARD AND
HAVE RECENTLY COMPLETED A PLAN
FOR DATA SHARING AND SOME THINGS
INCLUDING FOR A PUBLIC TIME AND
INCLUDING ACCESS TO JOURNALS
THAT HAVE JOURNAL ARTICLES THAT
REFLECT NIH SUPPORTED WORK.
WE ARE ALSO MOVING TOWARD HAVING
INVESTIGATORS WHEN THEY SUBMIT A
GRANT TO US THAT THEY LIE OUT IN
SOME DETAIL WHAT THEIR PLANS FOR
FOR DATA SHARING OF THE RESULTS
OF THEIR STUDIES AND THAT'S
CLINICAL STUDIES OR PRECLINICAL
STUDIES.
THAT IS SOME WAY INTO THE
DISTANCE AND I THINK IT'S
IMPORTANT TO START TO THINK
ABOUT HOW WE CAN PROVIDE
SPECIFICITY TO PERSPECTIVE
GRANTEES ABOUT WHAT OUR
EXPECTATIONS ARE IN TERMS OF THE
DATA SHARING PLAN, RECOGNIZING
HOW DIFFICULT IT WAS TO SPECIFY
WHAT WE WANTED TO HAVE HAPPEN IN
TERMS OF CLINICAL TRIAL DATA
SHARING AND ALSO IN GENOME DATA
SHARING WHERE WE HAVE A FINAL
POLICY ON THAT TOPIC AND
CERTAINLY WHAT'S CONSIDERED THE
DATA OF INTEREST AND WHAT
CONSIDERED SHARING IS QUITE
VARIABLE SO THAT MIGHT BE QUITE
DIFFERENT FROM A NEURAL IMAGING
STUDY TO A CRYSTALLOGRAPHY STUDY
TO SOMETHING ELSE.
WE HAVE TO THINK CAREFULLY ABOUT
HOW WE PROVIDE GUIDANCE ON THIS
BUT WE'RE MOVING RAPIDLY IN THIS
DIRECTION.
LET ME SHIFT GEARS NOW TO TALK
ABOUT CLINICAL RESEARCH AND
PROPOSING THAT WE REQUIRE WE USE
A SINGLE IRB FOR MULTISITE
STUDIES AND FOR ANY OF YOU WHO
HAVE BEEN INVOLVED IN DOING
STUDIES AT MULTIPLE SITES YOU
KNOW THE SHEER JOY OF DEALING
WITH THE INCONSISTENT COMMENTS
YOU GET WHEN YOU GO TO MULTIPLE
IRBs WHEN I WAS AT JOHN
HOPKINS I DID HUMAN SUBJECT
RESEARCH WITH INVESTIGATORS AT
SEVERAL OTHER ACADEMIC
INSTITUTIONS AND SO WE HAD TO GO
THROUGH, I THINK IT WAS A TOTAL
OF FIVE OR SIX IRBs IN ORDER
TO DO HUMAN SUBJECTS RESEARCH
LARGELY INVOLVING FOCUS GROUPS
AND SURVEY AND THOSE IRBs ALL
FELT COMPELLED TO LINE EDIT MY
SURVEY INSTRUMENTS IN COMPLETELY
DISCORD ANT WAYS.
SO IT HAS BECOME CLEAR AND
THERE'S SOME RESEARCH TO SUPPORT
THIS THAT THE KIND OF
INCONSISTENCIES AMONG IRBs
HAVE LITTLE TO DO WITH
PROTECTING THE RESEARCH
PARTICIPANTS INVOLVED.
AND SO THIS HAS BECOME AN ISSUE,
SO THIS SING ILLEGALS IRB FOR
THE COOPERATIVE ANSWER GROUPS
AND YOU MUST USE THEIR IRB,
UNLESS CAN YOU BEAT THEIR TURN
AROUND TIME AND LAST TIME I
CHECKED, HE SAID NOBODY HAS YET
SAID THEY COULD BEAT THEIR TURN
AROUND TIME FOR REVIEW WHICH IS
QUITE SPEEDY.
NEURONEXT WHICH IS NATIONAL
INSTITUTE OF NEUROLOGICAL
DISEASES AND STROKE, RESEARCH
NETWORK NOW HAS A SINGLE
MANDATORY SINGLE IRB REVIEW,
THEY'RE DOING THE SAME IN THE
STROKE RESEARCH NETWORK AND THE
CTSAs AND CLINICAL AND
TRANSLATIONAL SCIENCE AWARD,
MANAGED AND OPERATED BY THE
TRANSLATIONAL SCIENCES ALSO IN
THE PROCESS OF TRYING TO DEVELOP
SORT OF THE RESOURCES THAT ONE
WOULD NEED IN ORDER TO REAL
REALLY IMPLEMENT A MANDATORY
SINGLE IRB ACROSS THE BOARD.
LIKE THINGS LIKE RELIANT
AGREEMENTS AND WHAT KINDS OF
MECHANISMS DO YOU NEED TO HAVE
IN PLACE TO VALIDATE AND VERIFY
THAT THE OTHER GUY IS GOING TO
DO A FINE JOB REVIEWING THE
SUBJECTS RESEARCH.
THERE ARE SOME OTHER EXAMPLES OF
THE PROGRAM AND THE PUBLIC
HEALTH EMERGENCY REVIEW,
SOMETHING ELSE THAT BEGINS WITH
AN R--BOARD, AND THAT IS AN IRB
HERE AT THE NIH THAT IS INTENDED
TO BE ABLE TO RAPIDLY REVIEW
HUMAN SUBJECTS PROTOCOLS IN THE
FACE OF A PUBLIC HEALTH
EMERGENCY AND SO IMAGINE AN
OUTBREAK OF EMERGING DISEASES
FOR EXAMPLE.
SO THESE ARE SOME OF THE REASONS
WHY MOVING TO A SINGLE IRB MAKES
SENSE AND IT IS ALSO CONSISTENT
WITH THE PROPOSAL WE PUT
FORWARD, NOW, SOME YEARS AGO IN
THE PROPOSED MODERNIZATION OF
THE COMMON RULE WHICH IS THE
REGULATION GOVERNING INCLUSION
OF HUMAN BEINGS IN RESEARCH.
AND WE PROPOSED AT THAT TIME A
SINGLE IRB, THAT RECEIVES QUITE
POSITIVE COMMENT FROM
INVESTIGATORS, VERY POSITIVE
COMMENTS FROM PATIENTS AND
PATIENT ORGANIZATIONS AND MORE
INTEMEDUCATIONAL ORGANIZATIONS.
AND THERE'S A BILL THAT'S BEING
PUT TOGETHER IN THE HOUSE AND A
SIMILAR PROPOSAL IN THE SENATE
THAT WOULD EFFECT THOSE NIH AND
FDA AND STRONG SINGLE IRB AMONG
THOSE FOLKS.
SO THERE HAVE BEEN SOME COST
CALCULATIONS AND WE HAVE SOME
RESEARCH OUT--RESEARCHERS NOW
FUNDED TO LOOK AT SOME OF THESE
THESE RESEARCHERS AND THE REVIEW
COST AND THAT WILL BE IMPORTANT
TO CONSIDER AS WE MOVE FORWARD,
BUT PROBABLY MOST IMPORTANT IS
THE CONSISTENCY IN THE REVIEW
ITSELF AND HAVING THE IDENTICAL
PROTOCOLvm AT DIFFERENT SITES
HAVING THE SAME SORT OF ETHICAL
PARAMETERS ATTENDED TOO.
SO I WILL GIVE YOU A COUPLE OF
EXAMPLES, ONE IS PEDIATRIC
PROTOCOL WHICH WAS BY 34 IRB,
CAN 13 APPROVED PROTOCOL WITHOUT
CHANGES.
18 CONDITIONAL APPROVALS BUT NOT
CONSIST WENT ONE ANOTHER AND
THREE DEFERRED APPROVAL.
SIMILARLY AND OBSERVATIONAL
HEALTH SERVICES STUDY, 43
DIFFERENT IRBs AND A NUMBER OF
STUDIES THAT WE HAVE BEEN
INVOLVED IN RECENTLY IN LOOKING
AT CLINICAL RESEARCH CONDUCTED
IN NETWORKS LIKE THE NEW BORN
RESEARCH NETWORK AND OTHER
NETWORKS, THE NUMBER OF
DIFFERENT IRBs RESULT IN
REVIEWS, RESULTING IN DIFFERENT
CONSENTS FOR THE EXACT PROTOCOL
AND DIFFERENT INSTITUTIONS THAT
COULD BE JUST MILES JUST REALLY
BOGGLES THE MIND.
AND WE STRONGLY SUPPORT THE IDEA
FOR ANYTHING, ANYTHING,
ANYTHING, TO SHORTEN THE TIME
FOR A GREAT IDEA TO ASK THE
SCIENTIFIC QUESTION SO NOT
SURPRISING THAT VICTORYS ARE
SUPPORTIVE OF THIS.
WE ALSO HAVE BEEN SUPPORTING
RESEARCH FROM THE OFFICE OF THE
DIRECTOR, WE HAVE A DOLLOP OF
MONEY, I THINK IT'S 10 MILLION
DOLLARS A YEAR FOR BIOETHICS
RESEARCH AND WE HAVE DECIDED TO
DEVOTE THAT MONEY TO FUNDING
RESEARCH TO COLLECT DATA, THAT
CAN DIRECTLY INFORM POLICY
MAKING OF A SORT THAT IS
APPLICABLE TO ALL CENTERS AT THE
NIH, AND MADE A COUPLE AWARDS
LOOKING AT USE OF CENTRAL IRBs
AND THOSE ARE ONGOING NOW.
THOSE WERE AWARDS WE MADE LAST
YEAR.
WE HAVE THE SAME RFA OUT NOW AND
WE WILL MAKE MORE OF THESE
AWARDS THIS YEAR.
SO OUR DRAFT POLICY WOULD APPLY
TO NIH FUNDED MULTISITE STUDY IN
THE UNITED STATES.
THE IRB WOULD BE IDENTIFIED BY
THE APPLICANT AND APPROVED BY
THE FUNDING IC.
THERE WOULD BE SOME INCLUSION OF
COST FOR IRB REVIEW AS A DIRECT
COST ALLOWABLE IN THE AWARD AND
WITH ALL--WITH ALL RULES THERE
ARE IMPORTANT EXCEPTIONS AND SO
THE EXCEPTION WEES HAVE
CONTEMPLATED AND WE MAY
CONTEMPLATE MORE BASED ON
COMMENT WHEN WE GET THE COMMENTS
IN IS THAT THERE ARE SITUATIONS
IN WHICH SITE A AND SITE B ARE
REALLY DIFFERENT AND THAT THOSE
DIFFERENCES MATTER IN TERMS OF
BOTH THE IRB REVIEW AND
POTENTIALLY THE CONSENT AND WHEN
THE RULES WERE FIRST PUT IN
PLACE AND THE BELMONT REPORT
WRITTEN THERE WAS THIS NOTION
THAT THERE WERE LOCAL VALUES
THAT SHOULD BE TAKEN INTO
CONSIDERATION AND REVIEW OF
RESEARCH PROTOCOLS.
I THINK WITH OUR VERY MOBILE
SOCIETY AND THE WAY THAT
INVESTIGATORS MOVE FROM PLACE TO
PLACE, THAT'S PROBABLY LESS TRUE
TODAY THAN IT WAS THEN BUT
NONETHELESS THERE ARE CERTAINLY
SITUATIONS IN WHICH WE WOULD
WANT TO ALLOW FOR LOCAL IRB
REVIEW FOR DIFFERENT SITES AND
THEN OF COURSE THERE ARE SOME
CASES WHEN LOCAL IRB REVIEW IS
REQUIRED SUCH AS IN THE FDA LAWS
GOVERNING DEVICE TRIAL.
WE'RE TRYING TO CHANGE THAT
RIGHT NOW.
SO WE PUBLISHED--WE PUBLISHED
THIS PROPOSAL IN DECEMBER, WE
HAD IT OUT FOR 60 DAY COMMENT
PERIOD, WE HAVE 165 COMMENTS OR
THEREABOUTS AND WE'VE BEEN
TALKING TO THOSE GROUPS THAT
HAVE A STRONG INTEREST IN THIS
MATTER AND WE ARE AGAIN GETTING
GENERAL SUPPORT ALTHOUGH SOME
CONCERNS ABOUT WHETHER OR NOT WE
WANT TO DIVE IN WITH BOTH FEET
RIGHT AT THE GET-GO OR WHETHER
THIS COULD BE A STAGED
IMPLEMENTATION AND IF THAT WERE
THE CASE WHAT WOULD BE THE TRIAL
THAT YOU WOULD WANT TO HAVE THIS
REQUIREMENT PUT IN PLACE FIRST
FOR SO WE'RE IN THE PROCESS OF
THINKING THROUGH THAT AND
HOPEFULLY WE'LL HAVE A FINAL
POLICY OUT BEFORE TOO TERRIBLY
LONG AND WITH THAT I WILL
CONCLUDE AND BE HAPPY TO
ENTERTAIN QUESTIONS AND MAYBE
I'LL JOIN YOU AT THE TABLE?
>> I HAD A QUESTION FOR THE DATA
SHARING.
FOR BRANCH IN GENERAL SHARING
DATA DISSEMINATIONS ARE IN THERE
BUT WHAT--WHAT'S THE LEVER YOU
HAVE TO ACTUALLY BE SURE THAT
[INDISCERNIBLE] ACTUALLY COMPLY?
>> GREAT QUESTION.
SO AT LEAST WHEN I WAS A
GRANTEE, MY DATA SHARING PLAN
WAS THAT I PLAN TO HAVE GREAT
RESULTS THAT I WOULD PUBLISH AND
THATTA MY DISSEMINATION PLAN AND
MY EXPECTATION NOW IS THAT
CERTAINLY WITH THOSE KINDS OF
RESEARCH WHERE WE HAVE SPECIFIC
GUIDANCE THAT WE WOULD WANT
PEOPLE TO ATTEST THEY CAN COMPLY
WITH THAT AND SO THOSE TROOPS
MAY BE ABLE TO GENERATE MORE
SPECIFIC GUIDANCE FOR OTHER
KINDS OF DATA BUT TELL BECOME A
REVIEWABLE CRITERIA.
SO IT WOULD COUNT IN THE
EXPLORING OF THE APPLICATIONS.
>> BUT THAT'S THE APPLICATION
YOU SAY FOUR YEARS DOWN.
>> THAT'S A GREAT QUESTION AND I
DON'T KNOW THAT I HAVE AN ANSWER
TO IT, CERTAINLY--
>> I MEAN IT CERTAINLY COULD
COUNT AGAINST YOUR FUTURE
RESPONSIBILITY I GUESS IF YOU
DON'T SUPPLY IT.
>> THIS IS AN ISSUE WITH
CLINICALTRIALS.GOV AS WELL
BECAUSE YOUR FUNDING FOR YOUR
CLINICAL TRIAL MAY HAVE ENDED
AND IF YOU WERE COMPLIANT AND
THERE ARE THE ENFORCEMENT
MECHANISMS, BUT WHAT YOU MIGHT
WANT TO SEE HAPPEN IS THAT,
REVIEWERS FOR FUTURE GRANTS SEE
THAT YOU HAVE A TRACK RECORD OF
NONCOMPLIANCE AND NONDATA THAT
YOU'RE NOT A SHARER, RIGHT, AND.
>> I MEAN CATHY JUST ALLUDED TO
THIS BUT ONE OF THE REASONS WHY
THERE'S NO CLUB BEFORE BECAUSE
IT WAS ACTUALLY STATE THAD WAS
NOT A REVIEWABLE CRITERIA, SO,
SO--
>> YOU DO WHATEVER BUT HEY,
NOBODY WAS ACTUALLY DINGING YOU
ON YOUR APPLICATIONS.
>> YOU KNOW THERE'S GOOD REASONS
FOR--THERE'S--NOT GOOD REASONS,
THERE ARE REASONS FOR NOT
SHARING YOUR DATA.
>> YOU KNOW YOU DO AN
EXPERIMENT, YOU GET DATA BACK,
IT'S MODESTLY INTERESTING, BUT
NOT EARTH SHAKING DO YOU SUBMIT
IT TO JOURNAL ONE, IT GET
RESJECTED.
YOU SUBMIT IT TO JOURNAL TWO ASK
IT'S REJECTED AND THEN YOUR POST
DOC AND YOUR FUNDING RUNS OUT
AND YOU GET A NEW GRANT AND YOUR
MORE EXCITED.
I'M GUILTY, RIGHT?
I MEAN.
>> WE BOTH DID IT.
>> I'M GUILTY.
>> I HAVE A QUESTION AND
[INDISCERNIBLE] EACH OTHER AND
FUNDED BY THE GSA TO MEASURE NOT
JUST AN ENVIRONMENT ATTRIBUTE
AND PSYCHOLOGICAL AND CAPABLE
AND THE PRIME IN DIFFERENT PARTS
OF THE GSA HAVE SPOKEN.
[INDISCERNIBLE]
>> REALLY?
>> SO THE ISSUE IS WHEN'S DATA
DATA THAT IS SHAREABLE?
BECAUSE AND WE'RE RIGHT NOW
GRAPPLING WITH THE SUBJECTS ARE
GOING TO WANT TO KNOW, OKAY, HOW
DOES MY OFFICE SPACE IMPACT ME
AND SO WHEN CAN WE--WHEN SHOULD
WE, I MEAN IT'S SORT OF A
SENSITIVE ISSUE, DO YOU--YOU
SHARE THE DAILY BASIS THEA WITH
THE INDIVIDUAL AND THEN THE
OTHER PART OF THE GOAL IS FOR
THE GSA TO ACTUALLY IMPLEMENT
THE OUTCOME INTO BUILDING
OPERATIONS AND DESIGN AS QUICKLY
AS POSSIBLE O THERE'S KIND OF A
GRAY ZONE FOR WHEN IS DATA DATA,
WHEN IS IT SHAREABLE, WHEN WILL
IT RISK THE DESIGN OF THE STUDY
AND WHEN WILL IT RISK THE PEOPLE
WHO ARE THE SUBJECT ANXIOUS OVER
SOMETHING THAT MAY NOT BE
ACTUALLY SOMETHING THEY NEED TO
GET ACTIONS ON SO DO HAVE YOU
GUIDANCE ON THAT.
>> I DON'T.
>> BUT, SAYS NOT SIS DIMULAR
FROM A MORE COMMON CURRENCE IN
HEALTH SYSTEMS AND HEALTHCARE
DELIVERY WHICH IS WHAT THE
DIFFERENCE BETWEEN QUALITY
IMPROVEMENT ACTIVITY VERSES
RESEARCH.
AND THERE'S A TRIGGER THERE FOR
THE HUMAN SUBJECTS RULE, WHERE
QUALITY IMPROVEMENT IS USED,
DOESN'T MEET THE STANDARD OF
GENERALIZABLE.
NOW YOU COULD--THAT MIGHT BE
GROUP HOLE THAT YOU COULD DRIVE
A TRUCK THROUGH BUT THIS IS AN
ACTIVE AREA OF DISCUSSION AND
DEBATE AND MORE TRADITIONAL
BIOMEDICAL RESEARCH.
QUALITY IMPROVEMENT, SYSTEMS
IMPROVEMENT, INVESTIGATION.
>> YEAH, YEAH.
>> IN A DATA MANAGEMENT PLAN
AND
THERE'S NOTHING SECRET OR
CONFIDENTIAL THAT YOU HAVE TO
WORRY ABOUT, THE AGENCIES HAVE
NOT COME TO TERMS WITH THE FACT
THAT IT COSTS MONEY TO MAINTAIN
DATA AND IF YOU'RE GOING TO
MAINTAIN IT, PAST THE END OF
YOUR GRANT, HOW ARE YOU GOING TO
DO THAT AND SO IT'S EASY TO SAY,
YOU HAVE TO HAVE A PLAN AND YOU
HAVE TO DO IT, BUT HOW ARE YOU
GOING TO DO THAT.
>> YEAH, IT'S AN ABSOLUTELY
IMPORTANT ISSUE AND ONE IN
WHICH, THE ASSOCIATE DIRECTOR
FOR DATA SCIENCE, SPENDING HIS
TIME THINKING ABOUT THE PRETTY
UNUSUAL APPROACHES TO BEING ABLE
TO SUPPORT PEOPLE, SUPPORT THE
SHARING OF DATA WELL BEYOND THE
DATA ACCRUAL PERIOD AND SO HE'S
GOT SOME PRETTY WHACKY AND
INTERESTING IDEAS ABOUT THAT.
ANOTHER POINT IN THERE BUT I
CAN'T REMEMBER WHAT IT WAS.
SO, I THINK WE'RE GOING TO START
TO SEE THE EMERGENCE.
>> YES, DO YOU EXPECT TO HAVE
THIS UNDERSTOOD BEFORE YOU
MANDATE THE PROPOSERS HAVE TO
HAVE IT UNDERSTOOD?
>> WELL, NO BECAUSE WE'VE
ALREADY MANDATED IT FOR FILE
DATA SHARING AND FOR GENOME DATA
SHARING, RIGHT?
JERRY DID YOU WANT TO WEIGH-IN
ON THIS?
>> THERE'S A DIFFERENCE BETWEEN
HAVING A DATA MANAGEMENT PLAN
THAT MIGHT BE REVIEWED BY THE
REVIEWERS AND IT'S FREELYY GIVEN
THE STATE-OF-THE-ART AND ARE
THERE REPOSITORIES FOR IT.
>> AND THEN JUST SHARE THE DATA
AND IT'S NOT PUB LIKELY THERE
YET BUT THE POLICY WILL PROVIDE
A DATA MANAGEMENT PLAN AND
[INDISCERNIBLE] SO THAT WE CAN
SEE IF MAYBE THERE IS NO REALLY
GREAT REPOSITORY FOR IT THAT
MIGHT BE PART OF THINKING ABOUT
IT [INDISCERNIBLE] AND HOW IT'S
SUSTAINABLE.
SO IT'S GOING TO BE A QUESTION
OF--TO THE REVIEW PROCESS,
HERE'S WHAT YOUR PROPOSAL IS
DISTANCE WITH AND THE COMMUNITY
AND EXPECTATIONS, RIGHT?
SO YOU COULD WRITE A PROPOSAL
THAT SAYS, AND TO DO, AND AFTER
FIVE YEARS, I HAVE NO IDEA WHAT
WILL HAPPEN.
>> [INDISCERNIBLE].
>> [LAUGHTER]
>> BUT THE OTHER THING OF COURSE
IS THAT SOME PEOPLE HAVE AN
OBVIOUS PLACE, MAYBE IT'S THE
TINNIEST PROBLEM BUT THE OTHER
THING YOU WANT TO AVOID IS THAT
SOMEBODY HASN'T FIGURED OUT THAT
THEIR DATA BELONGS IN XYZ
REPOSITORY BUT IN THE MEAN TIME
IT WOULD BE FAR MORE USEFUL IF
THEY WOULD PUT IT IN THE PLACE
LIKE DATA.
>> THE OTHER ISSUE IN ADDITION,
TO PUT IT IN SUPPORT FOR
SOMEBODY TO MAINTAIN IT THERE
AND TO DISSEMINATE IT FROM THERE
IS ALSO SORT OF THE MOTIVATION
AND REWARDS FOR SHARING.
SO, YOU KNOW PRESENTLY, YOU GET
ACADEMIC CREDIT IF YOU PUBLISHED
YOUR CLINICAL TRIAL IN THE NEW
ENGLAND JOURNAL, BUT YOU DON'T
GET CREDIT AND IT'S NOT CITEABLE
AND IT'S CLINICALTRIALS.GOV, SO
MAKING--SORT OF STAFFING TO WORK
ON THE CULTURAL CHANGE OF CREDIT
AND WHAT IS CITEABLE IN THE
BIOMEDICAL RESEARCH WILL BE
IMPORTANT.
>> ANOTHER PIECE WE HAVE ALL
BEEN CONCERNED WITH THE
STANDARDS OF DATA AS OPPOSE TO
HAVING YOUR OWN MADE SOMETHING
UP WHEN THERE IS A STANDARD FOR
THAT TYPE OF DATA BECAUSE THE
VALUE OF YOUR DATA WITH PEOPLE
WILL BE GREATER AND THAT COULD
BE ANOTHER THING THAT WOULD BE
EVALUATED ON THE FACT THAT YOU
THINK IT'S GREAT TO MAKE UP
SOMETHING AND THE NEXT GENERAL
[INDISCERNIBLE].
>> THAT QUESTION?
>> I HAVE A WHY IS IT QUESTION,
KATHY.
BECAUSE IT HAS PARTLY TO DO WHAT
NIH CALLS ALL THESE
REQUIREMENTS, IF I REMEMBER IT
IN 84, 80% OF CLINICAL TRIALS
WERE PAID FOR BY NIH, NOW WE'RE
DOWN TO EIGHT OR NINE PERCENT
WHY IS THAT?
WE'VE GOTTEN MORE APPROPRIATIONS
ARE THINGS JUST THAT MORE
EXPENSIVE?
>> 80% OF ALL TRIALS WERE
SUPPORTED BY NIH.
>> I THINK SO.
>> YOU KNOW--
>> THE VAST MAJORITY.
>> THAT WOULD BE A HUGE EXPANSE,
IF THAT'S TRUE THEN THERE'S A
HUGE EXPANSION OF CLINICAL
TRIALS OVER ALL WHICH MAY IN
FACT BE THE CASE.
>> I DON'T KNOW.
>> BUT THE PERCENTAGE OF NIH'S
BUDGET DEVOTED TOWARDS CLINICAL
TRIAL HAS NOT HAS NOT SHIFTED
THAT MUCH BUT THE TRANSLATION
BETWEEN BASIC AND APPLIED
RESEARCH HAS BEEN STABLE AROUND
5050 FOR AT LEAST THE LAST 15
YEARS BUT I DON'T KNOW THE
ANSWER TO THAT DON, I WILL HAVE
TO LOOK AT WHETHER THE
PERCENTAGE OF ALL TRIALS THAT
ARE BEING SUPPORTED BY NIH HAS
SHIFTED.
:jY MAY HAVE GOTTEN MORE
EXPENSIVE BUT KIREMEMBER JIM
WENEGARTEN WOULD ANNUALLY SAY,
NIH HAS 40 APPROVED CLINICAL
TRIALS THAT WE CAN'T FUND SO WE
RAN THAT COUNT.
AND I DON'T KNOW IF WE DO THAT
ANYMORE.
WE PROBABLY DON'T BUT THE
PERCENTAGE IS WAY, WAY, SMALL.
AND THE PERCENTAGE I WOULD ASK
IS HOW DOES ANYONE KNOW.
I MEAN HOW DID THEY KNOW?
>> HOW DO YOU KNOW IF IT'S
NOMINATED OR NOT?
>> YEAH, SO MAYBE SOMEBODY HAD
THIS IDEA, BUT IT WOULD HAVE HAD
TO HAVE BEEN AN ESTIMATE BECAUSE
I THINK THAT AND THERE'S A
RIGHT, BUT, AND WE HAVE THIS
DISCUSSION SHORT BECAUSE WE'RE
EAT INTOG A RATHER BRIEF LUNCH
BREAK AND WE'RE GOING TO BE
HEARING MORE ABOUT BOTH OF THESE
TOPICS IN THE FUTURE SO, THANK
YOU AGAIN FOR EVERYTHING!
WE ARE GOING TO START WITH
JERRY WHO WILL TELL US ABOUT
CONTINUING THIS MORNING'S
DISCUSSION.
>> THANK YOU FOR THE
INTRODUCTION.
YOU HEARD ABOUT SOME OF THE
DEVELOPMENTS IN THE SHIFTS IN
CLINICALTRIALS.GOV AND CATHY
HUDSON'S REMARKS WHICH FOCUSED
ON REALLY TWO PIECES OF
NIH-RELATED ANDÁHHS DEPARTMENT
RELATED POLICIES AROUND CLINICAL
TRIAL REGISTRATION AND RESULT
SUBMISSION, ONE BEING THIS NPRM,
OR NOTICE OF PROPOSED RULEMAKING
AND THE OTHER BEING THE
ASSOCIATED NIH POLICY THAT I'LL
MENTION BUT I'M NOT GOING TO SAY
MUCH ABOUT, OTHER THAN IT REAL
LE FOLLOW ON TO THE PROPOSALS
THAT WE ARE MAKING IN THIS
NPRM.-ñfR
NOW THIS IS OF COURSE, NOT THE
FIRST TIME THAT YOU HEARD ABOUT
THE NPRM OR ANY OF THE
RULEMAKING.
NOW AS CATHY HUDSON SAID, NIH
HAS TAKE THEN ISSUE ON TRYING TO
INCREASE ACCESS TO THE RESULTS
OF CLINICAL TRIAL INFORMATION
BUT IF WE GO BACK ABOUT EIGHT
YEARS NOW, MORE THAN EIGHT
YEARS, A LOT OF THIS WAS
PROMPTED BY WHAT WE CALL THE FDA
AMENDMENTS ACT WHICH IS LOVINGLY
KNOWN AS FDAAA.
AS CATHY GAVE YOU A QUICK
OVERVIEW OF WHAT FDAAA DID AT
THE END OF 2007, EXPANDING ON
THE REQUIREMENTS OF REGISTRATION
AT CLINICALTRIALS.GOV AND
REPORTING OF SUMMARY ADVERSE
EVENTS AND THEN SPECIFICALLY
REQUIRING RULEMAKING AROUND
PARTICULAR ISSUES THAT I WILL
WALK THROUGH WITH YOU AND
DR. HUDSON NOTICED THIS CONTAINS
ENFORCEMENT PROVISIONS WHICH
MADE PEOPLE SIT UP AND PAY
ATTENTION BECAUSE UNDER THE
PREVIOUS LAW, THIS FDA
MODERNIZATION ACTED, THERE ARE
REQUIREMENTS FOR REGISTRATION
BUT NO PENALTIES IN PLACE
SPECIFIED.
SO THIS IS MOTIVATED A LOT OF
THE WORK AND YOU HEARD ABOUT THE
SYSTEM OVER TIME BECAUSE AS
DR. LINDBERG INDICATED EARLIER,
IT IS A LONG BUREAUCRATIC
TRANSPARENT PROCESS FOR MOVING
FROM A LAW INTO A REGULATION.
WHEN WE WOULD START WITH
ANNOUNCING SOMETHING IN THE
SO-CALLED UNIFIEDOA AGENDA AND
WALKING THROUGH THIS WINDING
PATH TO THE POINT THAT A RULE IS
IN PLACE AND TAKES AFFECT.
NOW, WHEN WE LAST MET IN
SEPTEMBER AS THE BOARD, AND I
GAVE AN UPDATE WHERE WE ARE WITH
THE NPRM, WE WERE ABOUT TO NET
BOX DOWN THERE.
WE DEVELOPED AN HHS, THE
DEPARTMENT CLEARED IT AND OMB,
OFFICE OFwNg%y MANAGEMENT AND
BUDGET,
WHICH HAS TO REVIEW THINGS
BEFORE THEY GO OUT FOR
PUBLICATION HAD CLEARED IT BUT
OF COURSE WHILE THEY WERE
REVIEWING IT THEY HAD A NEW
SECRETARY COME INTO OFFICE AND
WANTED TO MAKE SURE SHE HAD A
CHANCE TO KNOW WHAT IT WAS IN
AND WHAT WAS IN THE PROPOSALS
BEFORE IT WAS PUBLISHED IN THE
CENTER RECALL REGISTER.
SO AS IT WAS INDICATED --
CENTRAL REGISTER -- SINCE
SEPTEMBER WE TURNED THE CORNER
AND WE ARE NOW IN A PUBLIC
COMMENT PERIOD.
WHICH MEANS WE ARE A GOOD WAY
AROUND THE BEND BUT WE STILL
HAVE A WAYS TO GO.
AND I'LL TELL YOU A LITTLE BIT
MORE ABOUT THAT WAY.
WHAT GOT US AROUND THE BEND,
DR. HUDSON MENTIONED, WAS THAT
ON NOVEMBER 19, NIH AND HHS
ISSUED SIMULTANEOUSLY TWO BIG
POLICY ANNOUNCEMENTS.
THE FIRST WAS THAT WE WERE
ISSUING A NOTICE OF PROPOSAL AND
MAKING IT NPRM IN THE FEDERAL
REGISTER WHICH I'M SURE ALL
SUBSCRIBE TO AND READ DAILY.
IT IS A DAILY PUBLICATION WITH
ALL THE GOVERNMENT'S OPERATIONS.
AND THE SECOND, WAS AN
ACCOMPANYING ANNOUNCEMENT IN THE
NIH GUIDE WHICH SOME OF YOU MAY
READ IF YOU WOULD LIKE TO BE AN
NIH GRANTEE, WHERE2
GOES TO THE EXTRAMURAL COMMUNITY
AND THAT(Dô SPECIFIED THE
PROPOSED
NIH POLICY.
AND I'M GOING TO TELL YOU A
LITTLE BIT MORE ABOUT THESE.
I WILL ALSO SAY, THIS PAGE,
WHICH IS STILL AVAILABLE, THIS
IS ON THE NEWS AND EVENTS PAGE,
STILL A VERY GOOD RESOURCE
BECAUSE THERE ARE A LOT OF
RELATED LINKS TO THINGS LIKE
SUMMARIES WE PUT TOGETHER.
WHAT IS NEW IN THIS NPRM
COMPARED TO WHAT PEOPLE HAVE
BEEN DOING.
IN SOME CASES SINCE THE END OF
2007 IN TERMS OF REGISTERING AND
REPORTING RESULTS OF THEIR
TRIALS.
AND THERE IS ALSO DR. HUT HUDSON
MENTIONED HE AND COLLINS
PUBLISHED A COMMENT TEAR NEJAMA
THAT RAN THROUGH NIH'S
MOTIVATIONS FOR ACCOMPANYING THE
NPRM WITH A NIH POLICY AND
RELAYING SOME OF THE QUESTIONS
ABOUT LACK OF PUBLICATION AND
RESULTS AND INCOMPLETE
PUBLICATION RESULTS THAT SHE
REFERRED TO IN HER EARLIER
REMARKS.
SO WHAT IS THE NPRM?
POLICY PEOPLE DON'T OFTEN GET TO
COME WITH THINGS TO SHOW AND
TELL.
BUT I DID BRING A COPY TODAY.
SO NPRN IS A VERY DETAILED
REGULATORY PROPOSAL.
IF YOU WANTED THE DOUBLE SPADES
VERSION, THAT IS THE ENDEAVOR
MANY OTHERS ACROSS NIH HAD
PREPARED OVER THE COURSE OF MANY
YEARS.
ALMOST UP TO 500 PAGE DOUBLE
SPADES DOCUMENT.
THE ONE ADVANTAGE PERHAPS OF
PUBLISHING IT IN THE FEDERAL
REGISTER, THEY PUT THE FONT DOWN
TO ABOUT 9 POINTS AND PRINT IT
WITH ONLY THREE COLUMNS ON EACH
PAID AND IT GETS IT DOWN TO
ABOUT 116 PAGES.
WHICH IS STILL A LOT OF READING
AND IT'S A LOT OF WRITING.
TOOK US SO
MAYBE THAT'S WHY IT
LONG.
IT.
A LITTLE INTRODUCTION TOzrú
OF THAT 116 PAGES, ONLY ABOUT 18
ARE WHAT IS REALLY THE PROPOSED
REGULATION.
WHAT WOULD GO INTO THE U.S. CODE
OF FEDERAL REGULATIONS AS WE
PRESENTED IT?
98, THE MAJORITY IS WHAT WE CALL
THE PREAMBLE.
THE PREAMBLE COMES BEFORE THE
CODIFIED AND THE DOCUMENT
ITSELF, BUT THAT IS A VERY
DETAILED JUSTIFICATION OF THE
BACKGROUND, THE MOTIVATION, WHAT
THE LAW SAID, HOW WE INTERPRETED
THE LAW, WHAT OUR PROPOSALS ARE,
WHAT ARE THE ALTERNATIVES TO THE
PROPOSALS WE CONSIDERED AND WHY
WE THINK THIS IS THE BEST COURSE
TO TAKE.
WHEN YOU HAVE GOT LAWYERS AND
PEOPLE FROM ACROSS NIH AND THE
FDA AND OTHERS, SITTING AROUND
THE TABLE OR ROOM TRYING TO
DEVELOP THESE PROPOSALS, THAT
DESCRIPTION GETS QUITE LENGTHY.
AND IT93÷xr DID.
BUT IN ESSENCE WHAT THE LAW IS
TRYING TO DO IS SIMPLY IMPLEMENT
A SECTION OF THE PUBLIC HEALTH
SERVICES ACT WHICH WAS PUT IN
PLACE BY THIS FDAAAA WHAT WAS
THE EASY PART, WE ARE JUST GOING
TO CLARIFY WHAT WAS IN THE BASIC
LAW AND THEN WE ARE GOING TO
ADDRESS THESE ISSUES THE LAW
TOLD US WE NEEDED TO ADDRESS÷Y
RULEMAKING OF THE THESE ARE
ESSENTIALLY THINGS CONGRESS
DIDN'T GET TO RESOLVE OR THOUGHT
MORE DISCUSSION WAS NEEDED OF
BEFORE THEY COULD BE RESOLVED IN
RULEMAKING.
AND JUST A QUICK NOTE THAT IT IS
DIRECTED TO THE PEOPLE WHO ARE
SUBMITTING INFORMATION.
SO THESE ARE THE RULES AGAINST
WHICH A COMPLIANCE COULD BE
MEASURED IN TERMS OF OUR
RESUBMITTING INFORMATION WHEN
YOU ARE REQUIRED TO T DOESN'T
HAVE A LOT ABOUT OUR OWN
INTERNAL OPERATION ORES THINGS
WE MIGHT DO WITH CLINICAL
TRIAL.GOV.
SO I'M GOING RUNs% THROUGH THE
GENERAL SPECIFICATIONS THAT ARE
IN THE NPRN AND THE LET YOUg2<y
KNOW
WHAT IS IN THE LAW AND WHAT WE
ARE JUST ADOPTING AND WHAT WE
ARE PROVIDING ADDI
áì
JURISDICTION?
IND TO STUDY THAT OR IF NOT, ARE
YOU IN THE U.S. WHERE YOU'RE IN
A FACILITY THAT IS UNDER FDA
JURISDICTION?
OR AS THE PRODUCT AND
MANUFACTURE IN THE U.S. AND SENT
SOMEWHERE ABROAD.
THIS APPROACH BECOMES EASIER FOR
A RESPONSIBLE PARTY AND FOR US
TO DEMONSTRATE WHETHER A TRIAL
IS IN APPLICABLE PLAIN CALL
TRIAL OR NOT AND WHY OR WHY NOT.
REGISTRATION REQUIREMENTS ARE
TAKEN FROM THE LAW.
SO IF THE TRIAL WAS INITIATED
BEFORE -- OR AFTER THE 27th
OF SEPTEMBER, WHEN FDAAA WAS
ENACTED, OR 90 DAYS LATER, SO
MOST TRIALS ARE STARTED TODAY,
TRIALS, WOULD
THINK OF CLINIC
BE ASSEMBLE TO THE REGISTRATION
REQUIREMENT.
THE LAW SAYS IT HAS TO BE
REGISTERED NO LATER THAN 21 DAYS
AFTER THE PATIENT ENROLLS AND IT
LAYS OUT IN GREAT DETAIL FOUR
DIFFERENT TYPES OF INFORMATION
THAT NEED TO BE SUBMITTED.
THE LAW ALSO ALLOWED US TO
MODIFY THOSE REGISTRATION DATA
ELEMENTS AS LONG AS THE
INFORMATION WOULD NOT BE REDUCED
BUT WOULD BE IMPROVED AND NOT
REDUCED.
SO WE HAVE TAKEN THAT AUTHORITY
AND PUT IT OR EXERCISED IT BY
SPECIFYING A NUMBER OF
ADDITIONAL DATA ELEMENTS THAT
ñ CURRENTLY
MOST OF WHICH ARE
AVAILABLE.
THERE ARE OPTIONS ALREADY
ARE SAYING, HENCEFORTH PROPOSING
THEY BE REQUIRED.
THEY ARE THERE IN PART BECAUSE
IN MANY CASES THE DATA ELEMENT
THAT MIGHT BE SPECIFIED IN THE
LAW, WE THINK DOESN'T GIVE YOU
COMPLETE INFORMATION OR MIGHT
NOT GIVE YOU ACCURATE
INFORMATION.
SO A STUDY DESIGN NEEDS TO
CONTAIN THESE ELEMENTS OR
SUBDITA ELEMENTS ABOUT THE STUDY
MODEL.
WHEN YOU GIVE US AN FDAIND
NUMBER WE NEED TO KNOW WHICH
CENTER ISSUED IT.
THERE ARE CERTAIN ELEMENTS THAT
WE THINK ARE NEEDED TO JUST
IMPLEMENT OTHER PROVISIONS OF
THE LAW IN THE DATABASE.
WE NEED TO KNOW FOR EXAMPLE, IF
YOU HAVE A SINGLE-ARM TRIAL, DO
YOU CONSIDER IT TO BE
CONTROLLED?
WE ARE PROPOSING A NUMBER
THESE DATA ELEMENTS TO HELP
USISM WELLMENT PARTS OF THE
LAW -- IMPLEMENT PART OF THE
LAW.
SOME CASES WE NEED TO GIVEP, AN
OPPORTUNITY TO PROVIDE OTHER
INTERVENTION NAMES AND PROVIDE A
DESCRIPTION, AT LEAST ENOUGH TO
HELP US DIFFERENTIATE BETWEEN
YOUR DEVICE ANDTHARTHS MIGHT
HAVE BEEN STUDIED IN OTHER
TRIALS IN CLINICAL TRIALS GOV
AND THINGS THAT WERE NOT
SPECIFIED IN THE LAW BUT FOR
EXAMPLE, WE WANT TO KNOW THE
STATUS OF YOUR HUMAN SUBJECTS
REVIEW PROTECTION.
AND IF YOUR STUDY STOPPED,
BEFORE THEr
TERMINATED, WHY SO?
WE RECEIVED THIS INFORMATION AND
ESSENTIALLY WE ARE POSTING IT
ALONG THE TIME LINES THAT ARE
ESTABLISHED IN THE LAW.
SO, IF IT'S A TRIAL OF A DRUG,
OR OF AN APPROVED OR CLEARED
DEVICE WE ARE POSTING IT NOT
LATER THAN 30 DAYS AFTER IT IS
SUBMITTED.
THE LAW SPECIFIES WHAT WE CALL
THE LOCKBOX FOR TRIALS OF
UNAPPROVED OR UNCLEARED DEVICES
AND IT SAYS, YOU CAN ONLY SUBMIT
OR POST THAT INFORMATION AFTER
THE DEVICE IS CLEARED OR
APPROVED.
THERE ARE MANY, SOME IN THE DRUG
OR DEVICE INDUSTRY AS WELL THAT
COULD LIKE AN OPPORTUNITY TO
POST THEIR INFORMATION BEFORE
THAT.
I HAVE TO SAY WITH ALL THE LEGAL
COUNSEL AND ADVISORS WE H AROUND
THE WAY THE LAW WAS WRITTEN TO
ALLOW US TO VOLUNTARILY POST
THAT INFORMATION.
WE ARE ASKING FOR COMMENT ON
WHETHER OTHER PEOPLE HAVE
DIFFERENT WAYS OF INTERPRETING
THE LAW THAT COULD LET US GET
AROUND THAT IN THOSE KINDS OF
CASES BUT THAT IS THE PROPOSAL
THAT WE WOULD STICK WITH THE
OUTLINES.
SO THAT IS ALL ABOUTA5
REGISTRATION.
THE REALLY NEW PARTS ARE ABOUT
RESULTS REPORTING.
I THOUGHT THE EASIEST WAY TO
DEMONSTRATE TO YOU WHATçó WE ARE
PROPOSING IS TO TELL YOU WHAT
TH]Q#v÷ LAW SAID AND THEN SOME
ISSUE
WHERE IS THEY TOLD US TO MAKE
THE DECISIONS WHAT WE SAID.
SO UNDER THE LAW, AND DR. HUDSON
MENTIONED THIS BEFORE, RESULTS
SUMMARY RESULTS ARE REQUIRED FOR
ONLY STUDIES OF TRIALS AND
INTERVENTIONS THAT HAVE BEEN
APPROVED, CLEARED, LICENSED BY
THE FDA.
HAS TO BE SUBMITTED WITHIN A
YEAR OF THE COMPLETION DATE,
WHICH IS WHEN YOU STOP DATA
COLLECTION FOR A PRIMARY5a
OUTCOME.
MIGHT BE COLLECTING FOR
SECONDARY OUTCOMES.
YOU CAN REQUEST A DELAY FOR UP
TO TWO ADDITIONAL YEARS.
IF YOU CERTIFY THAT SAY YOU'RE
STUDYING A NEW USE OF THAT DRUG
OR DEVICE, THAT IS APPROVED OR
YOU'RE STILL OR AN UNAPPROVED
PRODUCT, OR YOU MAY HAVE COME UP
WITH A GOOD CAUSE REASON WHERE
YOU WANT TO REQUEST AN EXTENSION
FROM THE NIH DIRECTOR.
WE DON'T HAVE MUCH GUIDANCE ON
WHAT GOOD CAUSE WOULD BE.
AND THE LAW SPECIFIES THAT THE
TYPES OF INFORMATION THAT ARE
LISTED HERE ABOUT WHO IS IN THE
STUDY, WHAT WERE THEIR
DEMOGRAPHIC AND BASEK+
CHARACTERISTICS?
WHAT ARE THE OUTCOMES YOU
MEASURE DURING THE STUDDIE?
AND TABLES OF DATA ABOUT SERIOUS
ADVERSE EVENTS AND ANY OTHER
ADVERSE EVENTS THAT OCCURRED
MORE FREQUENTLY THAN 5% OF THE
TIME IN ANY ARM OFxD THE TRIAL.
THEN THE LAW SAID AND I SHOWED
YOU THIS IF YOU WERE HERE IN
SEPTEMBER AND YOU HAVE A GOOD
MEMORY.
I SHOWED YOU THIS TABLE.
THESE ARE THE OTHER ISSUES IN
WHICH THE LAW TOLD US WE NEEDED
TO MAKE DECISIONS VIAc
RULEMAKING.
FIRST ABOUT UNAPPROVED PRODUCTS.
SHOULD THEY HAVE TO SUBMIT
RESULTS AND IF SO, WHEN?
NARRATIVE SUMMARIES OF THE TRIAL
AND WILL ITS RESULT FOR THE LAY
PUBLIC OR TECHNICAL SUMMARIES.
THEY SHOULD BE INCLUDED WITHOUT
BEING MISLEADING OR PROMOTIONAL.
THE TOTAL STUDY PROTOCOL.
OR OTHER INFORMATION ON THE
PROTOCOL SHOULD THAT RESULT
SUBMISSION DEADLINE BE EXTENDED
FROM 12 MONTHS UP TO 18 MONTHS?
AND THEN ADVERSE EVENT
INFORMATION, WHAT IS THE BEST
METHODBi+a INCLUDING SERIOUS AND
FREQUENT ADVERSE EVENTS AND
CLINICAL TRIALS.
WE CAN THEN WALK YOU THROUGH
THESE.
SO WHAT WE SAID FOR UNAPPROVED
PRODUCTS WAS YES.
AND THEN REQUIRE THEM ON THE
SAME DEADLINE AS A TRIAL OF AN
APPROVED PRODUCT AND KEEP THIS
MECHANISM IN FOR CERTIFYING TO
DELAY FOR UP TO TWO ADDITIONAL
YEARS.
WE DEFERRED THE DECISION ON
SUMMARIES FOR REASONS I'LL SHOW.
WE ARE NOT PROPOSING TO REQUIRE
SUBMISSION OF PROTOCOLS.
I'M NOT GOING TOçó SAY MUCH MORE
ABOUT THIS.
EXTENDING SUBMISSION DEADLINE OF
THE WE NEVER HAD MUCH:ajBH INPUT
OR
SUPPORT FOR THAT.
THOSE WHO SUBMIT INFORMATION
WHEN HE HELD A PUBLIC MEETING
MANY YEARS AGO, WE HAVE WAYS TO
GET AROUND SOME OF THE CONCERNS
THAT PEOPLE MIGHT HAVE HAD ABOUT
THE DEADLINE.
AND FOR ADVERSE EVENT
INFORMATION, WE ARE STICKING
WITH PROPOSING LARGELY THAT
STATUTORY APPROACH OF SERIOUS
AND FREQUENT ADVERSE EVENTS BUT
INVITING COMMENT ON ADDITIONAL
INFORMATION THAT WE THINK WOULD
MAKE THAT DATA EVEN MORE USEFUL.
I PROBABLE DON'T NEED TO SAY
MUCH ABOUT WHY WE ARE PROPOSING
UNAPPROVED PRODUCTS.
WE THINK THERE IS INCREDIBLE
PUBLIC HEALTH BENEFIT FROM IT.
ONE IS LET'S MAKE SURE THAT AT
MINIMUM THAT SUBJECTS AREN'T
RECRUITED INTO OTHER STUDIES
THAT REPEAT THINGS THAT WERE
FOUND NOT TO WORK VERY WELL, OR
WERE HARM ENVELOPE STUDIES THAT
NEVER HAD TO REPORT.
MITIGATE SOME OF THE BIAS THAT
IS AVAILABLE ABOUT DRUGS AND THE
DEVICES AND CERTAIN TYPES OF
DRUGS AND DEVICES THAT ARE
PUBLISHED AND BIBLE AVAILABLE
THROUGH THE RESULT
INFORMATION -- THAT MIGHT BE
AVAILABLE.
AND WE ALSO FLAILS A LOT OFf;)K
PRODUCTS, THOSE UNAPPROVED
PRODUCTS, THERE IS INFORMATION
RELEVANT TO APPROVED PRODUCTS.
MAY HAVE BEEN UNAPPROVED PRODUCT
WAS STUDIED COMPARED TO AN"69&Ñ
APPROVED PRODUCT AND A LOT OF
CASES THE UNAPPROVED PRODUCT MAY
BE A DIFFERENT DOSAGE FORM OR
DIFFERENT FORMULATION THAN THE
APPROVED PRODUCT AND THERE IS
INFORMATION THAT COULD BE GAINED
ABOUT THE APPROVED PRODUCT.
OF COURSE THERE IS ETHICAL
OBLIGATION TO HUMAN SUBJECTS.
THEY VOLUNTEERED TO BE IN
STUDIES TO PROMOTE OR ADVANCE
SCIENTIFIC KNOWLEDGE.
THAT CAN BE MORE EASILY DONE IF
THE DATA AND INFORMATION ARE
AVAILABLE.
WE KNOW A NUMBER OF OTHER
COUNTRIES ARE ALSO MOVING IN
THIS DIRECTION AND WE THINK THE
CONCERNS ABOUT BUSINESS
CONFIDENTIALITY WHICH BECOMES
ONE OF THE MAJOR CONCERNS IN
MAKING THIS INFORMATION
AVAILABLE EARLIER, CAN BE
ADDRESSED BY THISSABILITY TO --
ABILITY TO DELAY THE SUBMISSION
OF DATA FOR UP TO THREE YEARS
AFTER THE COMPLETION DATE.
AND YOU CAN THINK ABOUT THAT FOR
MANY TRIALS, A PHASE II TRIAL, A
GOOD CHANCE YOU WOULD HAVE
STARTED YOUR PHASE III TRIAL
AFTER ABOUT THREE YEARS AFTER
THE COMPLETION DATE AND THAT IS
GOING TO BE REGISTERED ANYWAY.
IN OTHER CASES THREE YEARS WE
HAVE GIVEN YOU A LONG LEAD TIME
W
ONHt
THE DATA FOR ALL THE PUBLIC
HEALTH BENEFITS FOR THAT LONG.
WHAT WE ARE PROPOSING IS
ESSENTIALLY IF A SPONSOR OR
MANUFACTURE DECIDES A PRODUCT
WAS SO BAD OR NONEFFICACIOUS OR
HARMFUL, THAT THEY DON'T HAVE
THIS OPPORTUNITY TO DELAY.
SO WE ARE GIVEN THE OPPORTUNITY
TO DELAY IF YOU INTEND AND
CERTIFY YOU INTEND TO CONTINUE
TO RESEARCH AND POTENTIAL MARKET
DEVELOPMENT OF THE PRODUCT.
WE HAD TO INTRODUCE A LITTLE BIT
OF A WORK AROUND FOR THIS
LOCKBOX I MENTIONED.
SO, IF THIS IS A TRIAL OF AN
UNAPPROVED DEVICE, WE NEED TO
PUT THE RESULTS IN AND SPECIFIED
AND NEED TO YOU PUT IN
ADDITIONAL INFORMATION MUCH OF
WHICH IS SIMILAR TO THE
REGISTRATION INFORMATIONY SO YOU
KNOW WHAT WAS THE DEVICE THAT WE
STUDIED?
WHO ARE THE PATIENTS WHO
PARTICIPATED IN THE STUDDIE?
WHERE WAS IT CONDUCTED?
ALL THAT REGISTRATION
INFORMATION THAT IS VERY
ESSENTIAL IN SUNDAYING --
UNDERSTANDING THE RESULTS OF THE
TRIAL.
NARRATIVE SUMMARIES.
SO YOU KNOW DR. LINDBURG'S
POSITION ON THAT AND
SHARE THE POSITION ON IT.
I THINK WE WOULD SAY, IF YOU
COULD PRODUCE SOMETHING THAT
COULD BE DONE IN A WAY THAT IS
NOT MISLEADING OR PROMOTIONAL,
THERE COULD BE SOME BENEFITS
IT.
BUT WHO IS GOING TO PRODUCE THE
SUMMARIES?
MORE IMPORTANTLY PERHAPS, WHO
WILL REVIEW THEM AND MAKE SURE
THEY ARE NOT PROMOTIONAL OR
MISLEADING.
AND THIS QUESTION OF HOW DO YOU
INTERPRET THE RESULTS OF THE
SINGLE TRIAL AND THE CONTEXT OF
ALL THE INFORMATION AVAILABLE
AROUND IT.
SO YOU KNOW THAT DR. LINDBERG'S
POSITION ON THAT.
I THINK THERE IS ENOUGH INTEREST
IN THIS NOTION, COULD IT BE NONE
A WAY?
AND ARE THERE INTERESTING
EXPERIMENTS GOING ON WITH
RETURNING INFORMATION ABOUT THE
PATIENTS THAT ESSENTIALLY WE
DEFERRED THE DECISION AND
SOLICITING ADDITIONAL
INFORMATION ON THE TOPIC.
NOTING THAT NIH WILL CONTINUE TO
EXPLORE WAYS OF DOING THIS.
>> THAT IS WHAT THE LITERATURE
IS< ALL ABOUT.
WHEN YOU PUBLISH A RESULT, IT
ISN'T IMPLIED THAT EVERYONE
SHOULD START TREATING THEIR
PATIENTS BECAUSE YOU WROTE A
PAPER.
THE NEW ENGLAND JOURNEY BRINGS
TOGETHER TWO OR TJ7Tt COMPETING
INTERPRETATIONS.
THAT'S WHAT THE LITERATURE IS
FOR.
>> AND IN FACT, WHEN WE HELD THE
PUBLIC MEETING TO SOLICIT INPUT
ON THIS RULEMAKING BACK IN 2009,
THAT'S WHAT THE JOURNAL EDITORS
TOLD US.
AND CLINICALTRIALS.GOV BECAUSE
IT DOES THE RIGHT THING, WE LINK
TOUT ANY PUBLISHED ARTICLES
RELATED TO A TRIAL.
SO IN ESSENCE, THERE IS AN
OPPORTUNITY FORld#
ON THAT AND WE'LL HAVE TO
ADDRESS IT IN THE FINAL UEá
WE DON'T MAKE A PROPS TOOL DO
THAT IN THE NPRM.
SIMILARLY WITH THE PROTOCOLS, WE
HAD A BIT OF BACK AND FORTH OVER
WHETHER THE VALUE OF THE
PROTOCOL VERSUS THE COST OF
INCLUDING IT.
SO ESSENTIALLY WE HAVEN'T
PROPOSED IT BUT WE ALSO
SPECIFICALLY SOLICITED COMMENTS
ON THE BENEFITS OF DOING THIS IN
)Jz
LIGHT OF THE OTHERAVG-JTJUá
THAT IS IN CLINICALTRIALS.GOV.
SO BACK IN 2009 WHEN WE HAD A
"
PUBLIC MEETING ON THi
BOTH SIDES OFTHE ISSUE, THOSE
WHO THOUGHT NO WAY TO UNDERSTAND
WHAT HAPPENED IN A TRIAL WITHOUT
HAVING ACCESS TO THE PROTOCOL
AND OTHERS SAYING, YES, BUT.
YOU'RE GETTING A LOT OF
INFORMATION ALREADY ABOUT THE
PROTOCOL VIA REGISTRATION.
AND WE ARE GOING TO HAVE TO
REDACT NAMES AND PERSONAL
IDENTIFIABLE INFORMATION AND SO
FORTH.
SO WE SAID OKAY, WE REALIZE THAT
THE PUBLIC DIDN'T HAVE AN
OPPORTUNITY TO OW WHAT THE
COMPLETE SET OF DATA WOULD BE
AVAILABLE IN CLINICALTRIALS.GOV,
EITHER RESULTS OR PROTOCOL
INFORMATION IN THE REGISTRY.
SO, WE WANT COMMENT ON WHETHER
THE DATA WOULD BE SUFFICIENT TO
HELP IN EVALUATING THE RESULTS,
WHICH IS THE BAR%t+mEÑ SET BY
THE
LAW.
THIS IS THE PURPOSE OF DOING IT.
AND WHETHER ALL ORl0SÑ JUST
PARTS OF
THE PROTOCOL OR MAYBE FOR US,
THE STATISTICAL ANALYSIS PLAN AS
WELL WHICH MAY BE A SEPARATE
DOCUMENT, SHOULD BE SUBMITTED.
THAT IS ANOTHER TOPIC WE ARE
LOOKING FOR PUBLIC INPUTññÁON.
SERIOUS AND OTHER ADVERSE EVENTS
OCCUR MORE THAN 5% OF THE TIME.
IF YOU WANT TO TELL US ABOUT
ADVERSE EVENTS, ALL THE OTHER
ADVERSE EVENTS THAT HAPPENED
DURING THE TRIAL, YOU CAN DO
THAT AS WELL.
THE THRESHOLD IS AT LEAST THOSE
THAT OCCUR WITH FREQUENCY OF
MORE THAN 5% AND WE ARE
SOLICITING PUBLIC COMMENT ON
SOME OTHER INFORMATION WE MIGHT
COLLECT TO HELP PEOPLE INTERPRET
THE ADVERSE EVENTS.
WE WANT<ç+
AFFECTED BY SERIOUS ADVERSE
EVENTS AND THE NUMBER OF SERIOUS
ADVERSE EVENTS OCCURRED.
IT MAY BE MULTIPLE AND
INDIVIDUAL PEOPLE.
SOMExD INTEREST IN WHAT ABOUT
ATTRIBUTION?
HOW MANY WERE CAUSED BY THE DRUG
OR DEVICE?
TO ME THE BEST WAY TO TELL THAT
IS COMPArzz
ACTIVE VERSUS THE CONTROL ARM.
THERE IS SOME INTEREST IN
WHETHER OR NOT AN INVESTIGATOR
SHOULD TELL YOU THAT.
WE WANT TO KNOW ABOUT
POTENTIALLY THE>l!.s TIMEFRAME
DURING
WHICH THE ADVERSE EVENTS WERE
COLLECTED BECAUSE IT MIGHT BE
DIFFERENT ACROSS THE TRIAL OR
MIGHT HAVE ONLY COLLECTED
CERTAIN ONES COLLECTED DURING
CERTAIN PERIODS OF THE TRIAL.
WE ARE PROPOSING OR ASKING FOR
COMMENT ON ALL CAUSE AND
MORTALITY TABLE.
CAN YOU TELL US HOW MANY PEOPLE
PARTICIPANTS IN THE'EW! STUDY,
DIED
FOR WHATEVER REASON.
SOME OF THAT MIGHT BE EMBEDDED
IN OTHER ADVERSE EVENTS AND
OTHER TIMES IT MIGHT BE DROPOUTS
IN THE STUDY FOR VARIOUS
REASONS.
THERE ARE MANY, MANY OTHER
THINGS THAT ARE COVERED IN THE
NPRM AND I'M NOT GOING TO
ADDRESS THEM ALL HERE.
INCLUDING SOME PROVISIONS WITH
HOW QUICKLY DO YOU HAVE TO TELL
US WHEN YOU SUBMIT YOUR DATA TO
CLINICALTRIALS.GOV, HOW LONG DO
YOU HAVE TO RESPOND TO US AND
PROVIDE THE CORRECTEDHr?ñ
INFORMATION THAT RESOLVES SOME
OF THE PROBLEMS THAT DEBORAH AND
HER TEAM IDENTIFIED, WE ARE
SAYING WITHIN 15 DAYS BECAUSE WE
WANT TO MAKE SURE THAT WE MEET
OUR OBLIGATION TO POST THE DATAr
WITHIN 30 DAYS OF SUBMISSION.
AND WE WANT A RAPID CORRUPTION
3
OF ANY ERRORS WE FOUND IN
THE;v<J@
NPRM.
SO, AS MENTIONED, THE NPR.
SOMExWAVAILABLE IN THE SO-CALLED
DOCKET WHICH IS REGULATION.GOV,
ANOTHER WEBSITE I DON'T IMAGINE
n
MANY VISIT FREQUENTLY.]
THE PUBLIC COMMENT PERIOD WAS
INITIALLY 90 DAYS.
STANDARD IS ABOUT 60.
WE SAID WE'LL GIVE YOU 90
BECAUSE THIS IS MANY, MANY PAGES
TO GO THROUGH.
BASED ONIf%qUát REQUESTS WE HAD
Q'DING THE DEADLINEXFIFOR
FROM AFFECTED PARTIES, WE
ARE;vFú"
ESSENTIALLY ANOTHER 30 DAYS PLUS
THE
SO MEMBERSHIP 23rd AND THAT
FEDERAL REGISTER ANNOUNCEMENT
SHOULD COME OUT IN THE NEXT DAY
OR TWO.
SO, LOOK FOR THAT.
REGULATIONS.GOV.U SO FAR, THIS
IF YOU DO GO HERE, YOUçó CAN SEE
THE NPRM.
YOU'LL ALSO FIND A COUPLE OF
OTHER DOCUMENTS THAT MIGHT BEe1
HELPFUL IN HELPING TO YOU SORT
THROUGH THE NPRM, A SUMMARY OF?
THE KEY CHANGES FROMHt CURRENT
PRACTICE.
AND A SUMMARY OF THE NPRM
OVERALL, A LIST FOR EXAMPLE,
HERE ARE THE DATA ELEMENTS FOR
REGISTRATION THAT ARE CURRENTLY
IN CLINICALTRIALS.GOV REQUIRED
AND OPTIONAL AND THOSE PROPOSING
TO MAKEÑ÷a>#U%I
I MENTIONED THE JAMA ARTICLE
PUBLISHED TO GIVE AN OVERVIEW OF
THEçE
AND DEBORAH MENTIONED THIS
MORNING, SHE AND TONY PUBLISHED
SOMETHING IN THE NEW ENGLAND
JOURNAL IN DECEMBER.
IT TRIES TO LAYBu)YS OUT FOR THE
jt( AND CLINICAL
CLINICALYU
RESEARCH COMMUNITY, WHAT ARE
SOME OF THE KEY SCIENTIFIC
ISSUES OF INTEREST.
SO WONDERING IF I CAN JUST TELL
YOU TWO DATES.
THE PUBLIC COMMENT PERIODjF HAS
BEEN OPENED SINCE NOVEMBER 19 OR
20.
WE HAVE 300, ALMOST 350 COMMENTS
ALREADY.
MOST OF THESE ARE VERY SHORT
COMMENTS STATEMENTS LARGELY FROM
INDIVIDUALS WHO ARE
REPRESENTATIVES OF PATIENT
ADVOCACY GROUPS AND MIGHT BE
INDIVIDUAL CLINICIANS OR
CLINICAL REACHERS AND SYSTEMATIC
REVIEW ORDERS.
WHAT WE HAVEN'T HEARD FROM YET
ARE THE BIG INDUSTRY
ASSOCIATIONS, EITHER THE BIG
ORGANIZATIONS AND ASSOCIATIONS
RESEARCH GROUPS AND UNIVERSITIES
ARE REALLYi]
AND SO FORTH THATb
AFFECTED BY THE PROPOSED RULE.
AND I'M SURE THEY'LL WELCOME THE
EXTENSION OF A MONTH TO GET
THEIR COMMENTS IN AND THAT ALSO
MEANS HAVE YOU AN OPPORTUNITY TO
INFORM THEM THAT THEY ARE STILL
AN:v(
I<x:g THOUGHT I WOULD SHARE A
FEW OF
THE COMMENTS THAT HAVE COME IN
SO FAR.
EVEN THOUGH THESE
SNIPPETS, THERE ARE
SOMETIMES÷Ei>÷
NOT MORE THAN A FEW SENTENCES.
THEY COVER A LOT OF THE
MOTIVATION FOR THE RULE.
TOTAL SUPPORT OF THE ISSUE.
CAN'T MAKE PROGRESS WITHOUT --
[ READING ]
WE HAVEOÑ3;5%1e PHYSICIANS LOOK
AT HOW
DECISION-MAKING.
TRIAL PARTICIPANTS WHO BELIEVE
IbçZp EXTENDING TRANSPARENCY TO
ALL
TRIAL RESULTS.
A PARENT WHOSE DAUGHTER HAS BEEN
DIAGNOSED WITH THE DISEASE AND
WANTS TO ENSURE THAT HER
PHYSICIANS HAVE ACCESS TO UL AT
INFORMATION.
SYSTEMATIC
AND I WANT TO SEE ALL THE
$B
CAN DOD
AND I THINK THIS CAME FROM3L1Nn
AN
ADVOCATE IN@
SAYS WE CAN SEE WHAT IS
HAPPENING AND OTHERS CAN BUILD
ON THE RESEARCH RESULTS MORE
QUICKLY.
WE NEED MORE INSPIRATION AND
LOOK AT ONES LIKE THESE.
HUMANITY WILL OWE US A
GRATITUDE TO ENSURE THAT ALL
FUTURE TRIALS ARE UNDERTAKE WIN
MAXIMUM TRANSPARENCY AND
PROBABLY BIGGER THAN I THO5éKE
YOU WOULD HAVE
THIS TRIAL2Zi.÷ TRANSPARENCY
ISSUE
IN SAVINGTANTí
THE CREDIBILITY OF THE WEST.
THAT WAS YOURS.
SO, THESE ARE NOT REPRESENTATIVE
OF THE FULL SAMPLE THAT WILL
HE END OF THE EXCEPT
HAVE AT(0A
PERIOD BUT YOU REMEMBERq
MAKING IS ABOUTdLC
AND I DOUBT THERE ARE TOO MANY
REGULATIONS THAT THE GOVERNMENT
PUTS OUT TH
KINDSDrQñ OF THINGS FROM THE
COMMUNITIES AND I THINK IT ÷
TOUCH ON THE FACT WE ARE@íC)y
TOUCHING ON AN ISSUE THAT IS
IMPORTANT TO MANY AND I THINK IT
SOME GOOD.
IS DOING
SO WE[0úW%áUR&L INDIVIDUAL A LOT
OF
WORK TO DO.
WE WILL BE SOON AT THE POINT
WHERE WE GET TO THE RESPOND TO
THE COMMENTS AND THEN HOPE TO
MAKE IT AROUND THE BEND AGAIN TO
WHERE
RULE THAT WILL HAVE TO BE ALMOST
THIS THICK BECAUSE WE HAVE TO
DESCRIBE HOW WHY RESPONDED TO
EACH OF THE COMMENTS
SUBMITTEDñO'
AND HOW THAT --
>> [ OFF MIC
>> AND LET'S SAY'ñ06q IT'S NOT
GOING
4
SO WE WILL BE WORKING AS QUICKLY
AND %
THROUGH THE COMMENTS WHEN
TO THE POINT WE WILL HAVE A
FINAL RULE AND OF COURSE THE NIH
WILL BE FOLLOWING ON BECAUSE
THEY WANT TO APPLY THE SAME
PRINCIPLES TO ALL NIH FUNDED
TRIALS AND IF YOU WANT
ON THE PROPOSAL TO DO THAT THEY
HAVE A SEPARATE BOX SET UP TO
ACCEPT"
THAT'S ALL HI TO SAY.
AND I WELCOME ANY COMMENTS IF
YOU HAVE THEM.
THANK YOU.
[ APPLAUSE ]
>> THANK YOU FOR NOT FALLING
ASLEEP AFTER LUNCH IN A Vú-%Qç
DETAió
REGULATION.
>> IS THE GOVERNMENT'
RULES[Yu:R'?
MORE RULES?
;
WHY DO WE Ñ
I SO FAR -- THERE IS0_ ONE
COMMENTER WHO COMMENTS ON
EVERYxD
PROPOSAL THE GOVERNMENT
ISSUED.
Ky JUF
B. SORT OF WAIT FOR I
T
AN$rlNoá&r0ç
TO COME IN.
AND SO YOU CAN CONSIDER THAT
Am=ú
NEGATIVE ONE BUT I&W:bF WOULDN'T
SAY
IT WAS ON TOPIC.
WE HAVE GOTTENbí
COMMENTS IN TYPICALLY FROM THE
RESEARCH COME UPxD THEY SAY,
THIS
IS GOING TO BE AN ADDED BURDEN
TO HAVE TO DOwxSi THIS.
AND YES, ITn
BUT WE HAVE A LOT OF GOOD
REASONS WE JUST WENT THROUGH FOR
WHY WE THINK IT IS WORTH THE
BURDEN z]. )f!mCz LOT OF THAT
BURDEN
ISN'T IMPOSED BY US, THE
REGULATORS, A LOT OF IT REALLYZg
COMES FROM CONGRESS WHO IS
LISTENING TO CONCERNS ABOUT LACK
OF TRANSPARENCY AND NEGATIVES
RESULTS THAT NEVER BEENZg9ax
VETTED
w3 AIRED.
OR PUBLICLY÷FVQK
SO, I EXPECT WE'LL HEAR THOSE.
I EXPECT WE'LL HEAR BACK FROM
INDUSTRY THAT THIS IS A BURDEN
ON US TOO AND WEED LIKE MORE
TIME TO
TO DATE, THOSE ARE THE THICKER
AND WEIGHTIER COMMENTS COMING
CLOSING DATE.&
CLOSER TO THEPR
>> BACKING UP A FEW STEPS,
NIH LAWYERS TOOK THE POSITION IN
ORDER TO RESPOND TO THIS THING,
YOU HAVE TO HAVE RULEMAKING.
ÁWE WENT BACK TO THE CHIEF
SOl[/<
STAFFER WITH THE COMMITTEE
THATe8
SUGGESTED THIS LEGISLATION AND
SAID, WHY ARE THE HELL ARE YOU
DOING RULE MAKING?
WE DON'T WANT YOU TO DO
RULEMAKING.
WE WANT YOU TO FINISH THIS.e-J)
SO WE
ATTORNEYS ANÈ THEY SAID, YOU
KNOW WHAT?Yró. THEY SAID THA
T IN+<1;ç THE LAW,ú
THEYYm DIDN'T SAY ANYTHING
ABOUT
THE LAW AND OURL]iá
INTERPRETATION
IS THE ONLY WAY TO DO THIS IS
BYV
RULING.
AND WE TRIED OUR BEST TO DOT
THING IS OKAY BUT THE RULEMAKING
IS REALLY --
>> [ OFF MIC ]
Z
ZOQ
>> [ OFF MICg
[ MULTIPLE SPEAKERS ]
zT THIS BEFORE.
>> YOU HEARD ME SAY
THE LAW ACTUALLY IN MANY PLACES
COMBINES THE AMBIGUITY AND
SPECIFICITY.
SO, REALfá, IT IS VERY TRUÕk
WITHOUT SOME INTERPRETATION FOR
RULEMAKING, IT WOULD BE VERY
TOUGH IN A NUMBER OF CASES.
NOT OVER CASE BUT IT WOULD BE
TOUGH TO FIGURE OUT WHETHER THIS
THING IS IN OR OUT AND WHO IS
RESPONSIBLE FOR DOING IT AND
SO --
>> THIS HAS A LOT OF INTERNAL
CONTRADITIONS.
>> THE LAW DOES,'
>> YOU COULD GO BACK TO WHO
WROTE THES79
I GUESS TED KENNEDY.
ONE IS DEAD AND ONE IS RUNNING
FOR CONGRESS.
DO YOU BOTHER TO KNOCK ON THE
DOOR?
É $Rq
>> IúM
WHAT IS YOUR PURPOSE.
N4g
>> I THINK WE WOULD SAY, THEY
TRANSPARENCY OF CLINICAL
RESEARCH FOR THE BENEFIT OF
PATIENTS, RESEARCH COMMUNITIES,
GENERAL PUBLIC.
>> WHY DOWRY STRICT IT TO
DEVICESy1SKñ AND DRUGS?
>> THE LAW DID.
>> THAT'S THE LAW.
SO THE LAW SAID DRUGS AND
DEVICES AND THAT IS LARGELY THEY
ARE LOOKING AT WAYS OF
ENFORCEMENT AND 4]j/'Ñ THE
ISSUES
COMINGÑi UP THEYDM8q
THINK EVERY WEEK THERE WAS
SOMETHING IN THE WASHINGTON
TIME4Alá÷
OR IN THE FAVORITE PAPER ABOUT
PREVIOUSLY UNDETECTED SIDE SIDE
EFFECTS OF DRUGS OR DEVICES OR
UNREPORTED.
PROBABLY NOT UNDETECTED.
SO, I THINK THAT IS WHERE MOST
OF THE FOCUS WAS.
SO WE ARE FOLLOWING THE LAW AND
SAYING DRUGS AND DEVICES BUT
THAT IS WHERE THE NIH HAS SAID,
OKAY, THAT CAN BEá
BUT UNDER NIHA5 POLICY, IF NIH
IS
FUNDING YOU TO DO RESEARCH, WE
DON'T CARE WHAT THE INTERVENTION
IS, IF IT'S A CLINICAL TRIAL BY
OUR DEFINITION, WE EXPECT THAT
IT IS GOING TO SUBMIT THE SAME
INFORMATION AND ON THE SAME
TIMELINE.
>> [ OFF MIC ]
>> I DIDN'T SAY THAT ON THIS
IN%@#
AFFECT.
IF I GLOSSED OVER THAT QUICKLY
IN THE BEGINNING, I DIDN'T MEAN
TO.
THAT'S THE NIH POLICY, WHICH IS
A SEPARATE POLICY AND IN FACT,
IT WOULDN'T BE ENFORCED BY THE
FDAT WOULD BE ENFORCED BY NIH
THROUGH WITH HOLDING OF GRANT
FUNDS OR AS WE WERE DISCUSSING
BEFORE, IT MIGHT BE THE NEXT
TIME YOUR GRANT APPLICATION
NOT COMPLIANT,
COMES IF YOU'RE
WE COULDN'T PROVIDE WITH YOU
FUNDING.
>> [ OFF MIC ]
>> REMEMBER HOW SWEET SHE IS.
[ LAUGHS ]
>> SHOULD YOU SEE ME ON THE ICE.
MY FINAL QUESTION IS, DO YOU
HONESTLY THINK THAT YOU MADE
THIS AS SIMPLE AS IT CAN BE?
[ LAUGHS ]
>> WELL, I WOULD SAY HAVE WE
MADE IT AS SIMPLE AS WE
COULDm29N
MAKE IT GIVEN ALL OF THE
CONSTRAINTS ANDoWs AS BETSY
SAID,
INCONSISTENCIES SPEC AMBIGUITIES
AND SO FORTH?
AND THE FACT THAT IT DOES HAVE A
LOT OF PLAYERS INVOLVED FROM NIH
AND THE OGCs AND THE
REGULATORS OF FDA, AND THOSE AT
FDA WHO ARE CERTAIN PROCEDURES
AND($ @ TERMINOLOGIES.
SO WE HAVE -- ONE OF THE REASONS
WHY IT IS THIS LONG IS BECAUSE
WE HAVE TRIED TO BEt( INCREDIBLY
CLEAR ABOUT TRACING OUR
AUTHORITY.
HERE IS WHAT THE LAW SAID, HERE
IS WHAT WE ARE PROPOSING AND WHY
WE THINK IT IS A GOOD IDEA.
AND, TRYINGq
LOT OFçó INCONSISTENCIES
ABOUT I DIDN'T EVEN GO INTO.
LIKEu
FOR
THE LAW.
SIMPLE TEXT BUT A COMPLEX WAY TO
EXPLAIN WHAT IT IS.
>> WHAT I WILL TELL%1
WE MADE IT ASj8#%5A1
MAKE IT.
AND IT WOULD BE EVEN MORExD
CONVOLUTED IF JERRY, IN
PARTICULAR, I ON A FEW
OCCASIONS, HASN'T REALLY WON A
FEW ARGUMENTS.
BUT WE DIDN'T WIN THEM ALL.
AND IT WAS NOT US MAKING THE
FINAL DECISIONS ABOUT THE RULES.
>> ONE FINAL COMMENTA5 THEN.
>> AS TENLEY OR WALKER?
>> AS ME.
MY TEA PARTY FRIENDS TELL ME
REGULATIONS EXIST TO PUT
THATKé
THE EXECUTIVE OFFICE TO CHANGE
LAWS HOWEVER HE WISHES.
SO YOU CAN'T DO THAT WITH<buq
THESE.
YOU CAN'T DO SWEEPING
INTERPRETATIONS OF WHAT SHOULD
AND SHOULD NOT BE IN THERE.
OUR -- WE HAD MANY WAYS THAT WEp
COULD GET AROUND SOME OF THE
INCONSISTENCIES AND LAWS AND WE
HAD MANY PROPOSALS THAT WERE
DRAFTED BY A NUMBER OF US IN(
THIS ROOM.
AND WE WERE PUSHING A COMMON
SENSE APPROACH TO MANY OF THESE6
ISSUES2vs AND UNFORTUNATELY
DIDN'T WIN A LOT OF THESE
ARGUMENTS.
>> I MEAN SOME OF THIS COULD BE
BY US.
STREAMLINED BUT NOTNfQ
BUT BY THOSE WHO MIGHT WANT TO
RESIZE IT.
THERE WERE SOME BILLS THAT WOULD
TAKE SOME OF THE COMPLEXITIES
AND DO AWAY WITH IT AND EXTEND
THESE QUESTIONS OF SCOPE AND
APPLICABILITY.
>> OFF MIKE.
>> I THINK IT'S A RESULT OF
CONGRESS TRYING TO FIGHT BACK
WITH THE EXECUTIVE BRANCH
CHANGING THINGS WITH
REGULATIONS.
IN THE PAST, LAWS WERE BRIEFER
AND THE EXTENTIVE AGENCIES WHERE
THE EXPERTISE WAS WOULD PUT IN
SPECIFICITY.
NOW WE HAVE A LAW WRIT WIN A LOT
OF SPECIFICITY WHIT EN BY
CONGRESSIONAL STAFFERS WHO
DIDN'T HAVE EXPERTISE IN
CLINICAL TRIALS WHICH IS WHERE
YOU'LL GET MISTAKES.
BUT IN THEORY WHAT MY FRIENDS IN
POLITICAL SCIENCE TELL ME, THEY
ARE TRYING TO ENSURE THAT
REGULATORY PROCESS WE CANj
WHAT CONGRESS INTENDED.
IT'S A VICIOUS BAD CYCLE.
>> AND IN THIS PARTICULAR CASE,
AS WOO SAID BEFORE, I KNOW WE
HAVE TO MOVE ON, THE SENATE AND
THE HOUSE DISAGREED.
THEY SLAPPED TO THE THINGS
TOGETHER AT MIDNIGHT LITERALLY
AND THERE WAS NO COMMITTEE
REPORT WHICH USUALLY THE
COMMITTEE REPORT INDICATES WHAT
THEIR INTENTION WAS.
SO, WE DIDN'T EVENsT
REFER TO.
>> ALSO, ACTUALLY THE WHITE
HOUSE REFUSED TO LET US
PARTICIPATE IN WHAT IS CALLED A
TECHNICAL CORRECTION HEARING.
THINGS ALWAYS GET OUT OF WACK
WITH MISSPELLINGS@.a;TCRAP LIKE
THAT.
THERE IS ALWAYS A TECHNICAL
CORRECTION.
WE WERE INVITED TO SESSION AND
THE WHITE HOUSE SAID NO, YOU MAY
NOT GO.
>> [ OFF MIC ]
>> RIGHT.
>> THEY THOUGHT GOD, THEY ARE
GOING TO DO SOMETHING WORSE.
>> YOU NEVER KNOW WHAT THOSE
GUYS AT NLM MIGHT SAY.
>> EXACTLY.
>> DID ANYONE WANT TO TAKE A9
GUESS AT THE LENGTHS OF THE
MEDICARE BILL?
16 PAGES.
>> REALLY?
>> YES.çóO:S ÷
THAT'S IT.
>> WHAT ABOUT REGULATIONS?
>> WELL --
[ LAUGHS ]
>> 5000 PAGES.
>> ON THAT cRG÷
>> I'LL REMIND YOU AT LEAST
MAYBE THESE ARE TEA PARTIERS TOO
THAT ARE SENDING US SOME
POSITIVE QUOTES ABOUT THAT.
I THINK THERE IS A LOT OF
COMMUNITYA;Y
GOODNESS THAT IS BEHIND THESE
PROPOSALS.
>> THANK YOU.
SO WE ARE GOING TO NEXT
PRESENTATION BY JOYCE BACKUS
TALKING ABOUT THE NLM ROLE IN
PRESERVING THE COUNTRY'S
CULTURAL HERITAGE.
>> ALL RIGHT.
GREAT TO BE WITH YOU HERE TODAY
TO TALK ABOUT THIS TOPIC AND
FULL DISCLOSURE.
WHAT I'M GOING TO TALK ABOUT IS
NLM'S HISTORIC AND CURRENT ROLE
IN IDENTIFYING, COLLECTING,
PRESERVING, TRAINING OF
PROFESSIONALS AND PROVIDING
PERMANENT ACCESS TO THE
COUNTRY'S CULTURAL HERITAGE
BECAUSE WE THINK THIS IS ALL
PART OF THE PRESERVATION
PICTURE.
IN THE BEGINNING, OUR STARTING
DATE OF 1836, WE HAVE THIS
FELLOW IN HIS UNIFORM, ARMY
SURGEON GENERAL, THOMAS LAWSON
WHO TO CONGRESS FOR THE FIRST
REQUEST FOR COLLECTIONS AND I
DARESAY THAT EVERY YEAR SINCE,
WE HAVE GONE TO CONGRESS TO
REQUEST MONEY FOR COLLECTIONS.
A WHILE LATER, WE HAVE OUR
LONGSTANDING DIRECTOR, JOHN SHAW
BILLINGS, 27 YEARS OLD AT THE
TIME.
A PATHOLOGIST WHO SERVED AS THE
DIRECTOR OF OUR PREDECESSOR
ORGANIZATION FOR 30 YEARS, AND
HE DID A LOT OF AMAZING THINGS
IN OUR HISTORY OF CREATING A
COLLECTION.
HE PROVEN HIS APTITUDE FOR THIS
TASK HAVING BEEN ASSIGNED THE
STATISTICS AND PRESERVING THE
MEDICAL SPECIMENS TO BE SENT TO
THE ARMYé@ MEDICAL MUSEUM.
SOfá WITH THAT BACKGROUND, HE
CAME
TO US AND I JUST THOUGHT ISLAND
SHARE WITHlp YOU, SINCE WE
BECAME
THE ARMED FORCES MEDICAL
LIBRARY, THIS IS THE ENTIRE
HISTORY AND OF COURSE, RIGHT IN
HERE, WE BECAME THE NATIONAL
LIBRARY OF MEDICINE UNDER FRANK
ROGERS DIRECTORSHIP.
YOU CAN SEE WE ONLY HAD TWO
DIRECTORS SINCE THEN.
BACK TO JOHN SHAW.
SO OUR LIBRARY WAS REALLY JUST A
ROOM FULL OF BOOKS THAT WAS IN
THE FIELD BEFORE BILLINGS TOOK
OVER AND CREATED AN ACCURATE
CATALO7M,f
LIBRARY.
THIS IS HIS FIRST SPECK CATALOG
WHICH RECEIVED ENTHUSIASTIC
RECEPTION BY THE MEDIN
PROFESSION.
THIS IS A SPECK PUBLICATION TO
SECURE FUNDING FOR THE CATALOG
FROM CONGRESS, AND HE HAD
ALREADY ENVISIONED A NATIONAL
j]Z2
FORESHADOWING.
AND HE CREATED AN INDEX CATALOG
FOLLOWING PUBLICATION.
LET'S FAST FORWARD MANY YEARS TO
1944.
SO WE SAW THERE WERE A LOT OF
DIRECTORS IN THAT TIME HERE AT
THE ARMY MEDICALz5eG LIBRARY.
THE ROCKEFELLER FOUNDATION
COMMISSIONED A REPORT WHICH WAS
UNDER THE AUSPICES OF SOME
VERYES TEAMED PEOPLE IN THE
LIBRARY SCIENCES FIELD.
THIS REPORT CRITICIZED US
STRONGLY AND MADE MANY
RECOMMENDATIONS FOR IMPRO
OUR FACILITIES, OUR PRODUCTS,
OUR SERVICES, AND OUR STAFFING
AND PROVIDED SUPPORT FOR
INCREASED FUNDING AND MAJOR
CHANGES IN OPERATIONS.
SO, THIS REPORT WAS SO IMPORT TO
COLONEL JOSEPH WHO WAS OUR
B
46-49, THAT HE IN
DIRECTOR FROM
SCRIBED IT AS SUCH, AND I'M
HAPPY TO SAY, I HAVE THE ACTUAL
INSCRIPTION HERE AND I'M NOT
SURE TO WHOM HE WAS WRITING BUT
IN 1946-49, WHICH WAS HIS TENURE
AS A DIRECTOR, THIS WAS HIS
BIBLE.
AND #EU LIKE THIS PHOTO
BUT KEN HELPED ME UNEARTH THIS
PHOTO WHERE I THINK HE IS MAYBE
CHANNELING THE FUTURE ELVIS.
AS JUST AN ASIDE, THE HISTORY OF
THE LIBRARY DOES NOTE THAT THE
COLONEL AS DIRECTOR OF THE
LIBRARY QUOTE, FELL IN LOVE WITH
ELEANOR COFFIN, THE ABLE HEAD OF
THE REFERENCE SECTION AND THEY
WERE MARRIED.
THAT HAS NOTHING TO DO WITH OUR
COLLECTION.
[ LAUGHS ]
OKAY.
PART OF THE REPORT WAS THE
LIBRARY SHOULD ACQUIRE THE
PUBLICATIONS THAT WOULDN'T
SURPRISE YOU BUT SOMETHING THAT
BUT THEIR
MIGHT SURPR?K
RECOMMENDATION WAS THAT WE
SHOULD ALSO COLLECT THE QUACK
AND THE CRANK.
NOT MAYBE
AT LEAST IN THEIR SAMPLE.
AND I'M PLEASED TO REPORT THAT
WE HAVE NO TROUBLE IN TODAY'S
WORLD OF PUBLISHING TO ACQUIRE
AT LEAST A FEW OF THE QUACK AND
CRANK PUBLICATIONS.
SO WE DEFINITELY CONTINUE IN
THAT WAY TO A SMALL EXTENT.
FAST FORWARD AGAIN FOLLOWING THE
1944 REPORT AND THE LIBRARY
DEVELOPED THIS 1951 POLICY UNDER
FRANK ROGERS LEADERSHIP.
THIS REPORT÷J1,V((SRáRQ" A
CONTINUING COMMITTEE ON SCOPE
AND COVERAGE AND AGREED
THATD-Jçz NLM
WOULD EXPAND AND USE THE LIBRARY
OF CONGRESS'S W CLASSIFICATION
SCHEDULE FOR MEDICINE WHICH WE
STILL USE TODAY FOR THE NLM
CLASSIFICATION.
ANOTHER TREASURE THAT I FOUND IN
OUR COLLECTIONS WAS THIS PHOTO
WHICH IS NOT THE PHOTO OF THE
REPORT BUT IT'S A PHOTO OF THE
VETERAN'S ADMINISTRATION LIBRARY
SERVICES COMMIT.
THIS IS FRANK ROGERS HERE.
AND AS A BODY SITTING HERE, I
HOPE YOU'RE HAVING HALF AS MUCH
FUN AS THESE GENTLEMAN WERE
DURING THEIR PHOTO BECAUSE THE
PHOTOGRAPHER MUST HAVE JUST SAID
A GREAT JOKE BECAUSE THEY ARE
HAVING A REALLY GOOD TIME.
SO, FROM THAT TIME, WE HAD
ANOTHER THOUGHT ON ACQUISITIONS
AND HELD A PROCEEDINGS, OR
SYMPOSIUM IN APRIL OF 1956.éKñ
THIS SYMPOSIUM WAS NOTABLE
ESPECIALLY FOR ITS TIMING.
ONE OF THE LECTURES ENDS WITH, I
CERTAINLY HOPE THAT THE LAW
BRINGING US INTO BEING AS THE
NATIONAL LIBRARY OF MEDICINE
ACTUALLY COMES TO BEING, WHICH
IT DID.
SO IN THE FORWARD, SAMUEL, THE
ASSISTANT LIBRARY SAYS QUOTE,
THE PRESENT ACQUISITION POLICY
OF THE NL.
SOME BASED ON THE)W
OF THE 1944 SURVEY I MENTIONED
SAYING THE LIBRARY SHEACQUIRE
ALL PUBLICATIONS AND ALL
LANGUAGES DIRECTLY RELATED TO
THE SCIENCE OF MEDICINE AND THAT
WE HAD FOLLOWED THIS
RECOMMENDATION AS FAITHFULLY AND
DILIGENTLY AS OUR RESOURCES
PERMITTED AND I'D LIKE TO SAY WE
HAVE CONTINUED THAT TO THAT DAY.
SO YOU CAN SEE, THE SYMPOSIUM
HAPPENED IN 56.
IT DIDN'T COME OUT UNTIL THE
NEXT YEAR IN 1957.
AND WE ARE VERY HAPPY TO REPORT
THAT IN THAT INTERIM TIME, WE
DID BECOME THE NATIONAL LIBRARY
MEDICINE.t(
SO, AS THE NATIONAL LIBRARY OF
MEDICINE, WE ARE PART OF THE
U.S. CODE AND I JUST WANTED TO
SHARE WITH YOU SOME OF THE
REALLY KEY PARTS OF THAT CODE
THAT HAVE TO DO WITH THE
BUILDING OF OUR COLLECTION.
IN PARTICULAR, THE FIRST THING
WE ARE ASKED TO DO IS TO ACQUIRE
AND PRESERVE BOOKS, PERIODICALS
AND PRINTS AND FILMS AND
RECORDINGS.
Ñ THIS.
WOO WE LOVEA<
OTHERQá<Y LIBRARY MATERIALS.
THE PEOPLE IN 1956 CANNOT HAVE
BEEN THINKING OF THE USB DRIVE,
THE VIDEO DISKS WE HAVE, THE
PHONES ON WHICH YOU ARE NOW CORE
CARRYING BOOKS.
BUT THEY HAD THE FORETHOUGHTZ3áO
PRESCRIBE THAT WE COLLECT OTHER
LIBRARY MATERIALS AND OF COURSE
WE STILL CONTINUE TO DO SO.
THEY WERE ALSO VERY FORWARD
THINKING IN THEIR DEFINITIONS OF
BOTH MEDICINE, INCLUDING ALL OF
THESE AREAS.
AND IN THEIR DEFINITION OF
SCIENCES RELATED TO HEALTH AND
THESE ARE CLEARLY PART OF OUR
COLLECTION RESPONSIBILITIES
TODAY.
SO, I DON'T HAVE THE DATE OF
THIS PHOTO.
IN 1976, BETWEEN THE PASSING OF
THE PUBLIC LAW DURING THE TENURE
OF FRANK ROGERS, AND THE
BEGINNING OF THE 1984 TENURE OF
DON LINDBERG, YOUR PREDECESSORS
ON THIS BOARD OF REGENTS,
ESTABLISHED THIS COLLECTION
DEVELOPMENT POLICY.
SO THIS IS THE 1976 POLICY OF
YOUR BOARD AND YOU CAN SEE IT
WAS UPDATED IN 1983 AND 1992 AND
I WILL JUST HIGHLIGHT A FEW
IMPORTANT POINTS T67<÷ BODY
MADE.
BACK TO ANY KIND OF MATERIALS,
WE COLLECT FORMAT DEEMED
APPROPRIATE, THEY PARTICULARLY
CALLED OUT THE HISTORY OF
MEDICINE AS AN AREAY
AND I'LL TALK ABOUT THE
INTERDEPENDENCE OF OUR LIBRARIES
AND LASTLY, AS ANY GOOD POLICY
SHOULD DO, CALLED ON US TO
ESTABLISH A GROUP,t( WE WON'T
DALA
COMMITTEE BUT A GROUP OF SENIOR
STAFF DESIGNATED BY THE DIRECTOR
TO MEET AND COME UP WITH A
COLLECTION DEVELOPMENT POLICY
AND I'M HAPPY TO SAY, WE DID SO
AT THE TIME AND HAVE CONTINUED
TOí5eL DO SO.
THIS IS NOT THE MOST BEAUTIFUL
OF OUR COLLECTIONS BUT IT IS ONE
OF OUR DOCUMENTS AND POLICIES'c
AND ONE OF THE MOST UTILITARIAN.
YOU CAN GO TO OUR COLLECTION
DEVELOPMENT POLICY AND LOOK UP
THESE TOPICS AND FIND OUT TO
WHAT EXTENT WE COLLECT IN THIS
AREA AND TO WHAT EXTENT MAYBE
THE COLLECTION IN THAT AREAmÑ
FALLS TO THE NATIONAL
ç3
LIBRARY OF CONGRESS.
AS YOUR POLICY REQUIRES, WE
MAINTAIN THIS DIALOGUE WITH
THESE OTHER NATIONAL LIBRARIES
AND ISSUE JOINT COLLECTING
STATEMENTS DEFINE AREAS OF
MUTUAL<ú<"Ñ INTERESTS.
OVER4E
COOPERATIVE STATEMENTS ON THESE.
SO SHORTLY AFTER DR. LINDBURG
AARRIVE, THE LONG RANGE PLANNING
REPORT OF 1986, INCLUDED THIS
DOCUMENT REPORT.
BUILDING AND ORGANIZING THE
LIBRARY'S'S COLLECTION.
THIS IS CLEAR IN AFFIRMING THE
ROLE TO SERVE AS A LIBRARY OF
RECORD FOR MEDICINE AND HEALTH
SCIENCES BECAUSE SUCH A
RESPONSIBILITY IS CONSISTENT
WITH THE NATIONAL MANDATE.
THEr#.& 2000-2005 LONG-RANGE
PLAN
EMPHASIZES 7 PARTICULAR
IMPORTANT AREAS OF EMPHASIS AND
THE ONE IMPORTANT FOR TODAY IS
PERMANENT ACCESS TO ELECTRONIC
INFORMATION.
SO WE WENT FROM OTHER LIBRARY
MATERIALS IN OUR LAW TO YOUR
BOARD OF REGENTS TALKING ABOUT
OTHER MATERIALS IN THEq
PLAN PARTICULARLY CALLING OUT
HAVING LEADERSHIP AND PERMANENT
ACCESS TO DIGITAL MATERIALS.
AND OUR CURRENT PLAN IN GOLD ONE
CALLS FOR SEAMLESS UNINTERRUPTED
ACCESS TO?N0
AND OUR RECOMMENDATION OF 1.2
PARTICULARLY CALLS PRESERVATION
IN HIGHLY USEABLE FORMS AND I'LL
TALK ABOUT HOW WE BELIEVE
PRESERVATION MUST ALSO INVOLVE
PERMANENT ACCESS.
LET'S TALK ABOUT PHYSICAL SPACE.
THIS IS FRANK ROGERS ON THE
OPENING OF THIS BUILDING
INd$Rj)i;
THE BUILDING IS ONE OF THE FIRST
ELEMENTS IN PRESERVING OUR
COLLECTION AND WE HAVE DONE SOME
WORK OVER THE LAST COUPLE OF
DECADES TO*f@U)r ENSURE THAT IS
THE
CASE.
WHEN WE DID STUDIES IN THE 90s
AND LOOKED AT HOW LONG THIS
BUILDING COULD HOLD THE
MATERIALS, WE WOULD EXPECT TO BE
COMING IN, IT LOOKED LIKE WE
WERE DUE TO RUN OUT OF SPACE IN
2010 AND I'M HAPPY TO SAY WE DID
NOT RUN OUT OF SPACE BECAUSE WE
HAD GOOD PEOPLE WORKING ON THIS
PROBLEM.
THIS COLLECTIONS IN THIS
BUILDING ARE LOCATED ON A GROUND
FLOOR BASEMENT LEVEL THAT IS
BUILT ON ROCK AND THEN SECOND
LEVEL AND THEN A THIRD LEVEL AND
IF YOU GO TO THE MOST UPPER MOST
LEVEL IN THE BASEMENT, IT'S
STILL LOOKING LIKE THIS AND YOU
CAN SEE THE SHELVING WHILE NOT
LIGHT AND AIRY IS NOT AS HEAVY
AS COMPACT SHELVING.
SO WE HAD PUT COMPACT SHELFING
ON GROUND LEVEL.
BUT I'LL SHOW YOU WHY FIGURED
OUT A WAY TO ADD SHELVING
TOnN!Ñ THE
SECOND BASEMENT AND ADD 7000
LINEAR FEET OF SPACE.
AT THE CURRENT RATE OF
GROWThLC/ WE
ARE EXPECTING, WE ARE GOOD TOçó
2030.
WE NOW HAVE 2.6 MILLION VOLUMES
AND NEW LIGHTING AND FIRE
SUPPRESSION SO HOW DID WE D}X<
IT?
SO HOW WE DID THIS WAS OUR
ENGINEER CAME UP WITH SOMETHING
CALLED FIBER REINFORCED POLYMER
OR FRPw.+o AND THIS IS A SAMPLE
OF
IT.
THEY ARE FIBERS MADE OF GLASS,
KEVLAR AND CARBON AND
SEE WHEN THEY ARE PUT YOU SHOULD
THE RESIN, THEY DON'T EACH NEED
TOM0bz COATED ON THE WHOLE
FLOOR.
THEY ARE POTOMANIA GRID OF THIS
IS FLOOR OF ONE LEVEL AND ALSO
APPLIED TO THE CEILING OF THE
LEVEL BELOW.
SO THROUGH THE MAGIC1ó>3 OF
THIS
FABRIC, WE WERE ABLE TO EXPAND
OUR CAPACITY FOR THAT
SQUARE FEET THERE WAS A NOTE
THAT SAID ALL COLLECTIONS WERE
HERE IN THIS BUILDING.#46x
ALMOST 4No
WE ALSO HAVE KEY MICROFILM AND
FILM IN THIS FACILITY IN WESTERN
PENNSYLVANIA.
WE WILL DRIVE YOU INSIDE AND
THERE IS NOT A LOT GOING ON IN
THERE AND WE
WE DON'T WANT A LOT OF
ACTIVITY÷E"!,xúñ;P
GOING ON AROUND OUR MATERIALS.
THIS IS A LIVE VIDEO -- KIDDING.
BUT THE LIVE VIDEO WOULD LOOK
LIKE TO THIS BECAUSE NOTHING IS
HAPPENING IN THAT ROOM RIGHT
NOW.2-
55,000 MICROFILM CAMERA MASTERS
IN HERE THAT RECORD THE THE
INFORMATION ON#,
BRITTAL
ARE STORED ON PAPER SO THEY ARE
ENJOYINGdj4, THIS COOLms
THE GATESó7 FOUNDATION AS SEEN
HERE.
>> HIS PERFORM COLLECTION.1;x:c
>> SO, YOU CAN'T COLLECT AND
PRESERVE WITHOUT HAVING PEOPLE
TO DO SO.
OURpi
TRAINING IN MEDICAL AND LIBRARY
SCIENCES.
BUT WE HAVE TAKEN AND WE DO AS
VALERIE CAN TELL YOU.
WE GIVE A LOT OF GRANTS FORníí
TRAINING IN SCIENCES OF ALL
SORTS BUT WE HAVE HAD A
COMMITMENT TO TRAINING HERE AT
THE LIBRARY FOR A NUMBER OF
YEARS.ípAfç
SO, WE SPONSORED RECENT
SCHOOL GRADUATES ANDIFj0 HEALTH
SCIENCE LIBC/ó/
YEARS AND WEZp HAD OVER 270h@8
PARTICIPANTS IN THE ASSOCIATE
FELLOWS PROGRAM.
WE ALSO PARTNER WITH THE
ASSOCIATION OF ACADEMIC HEALTH
SCIENCES LIBRARIES TO SPONSOR A
MIDtyr=ÑéxRQ) LEADERSHIP)I%
THAT HAD OVER 50 PARTICIPANTS.
WE WORK WITH THEDÑ"@ NATIONAL
: ALLIANCE TO
DIGITAL STEWARDSHIPt
SPONSOR RECENTs
ABOUT TO HOST ANOTHER.
WE HOST1+g LIBRARY SCHOOL
STUDENTS
HERE FOR A WEEK AND SOMETIMESD8
MORE AND WE HAVEn-Z.?HJ
IN DISASTER RECOVERY ANDíf!Hñ
MANAGEMENT.
NOW WE'LL TELL YOU ABOUT THE
SPECIFIC PRODUCTS ONGOING
FORp[l< A
NUMBER OF YEARS TO COLLECT,
PRESERVE AND BRING THAT
INFORMATION OUT FOR PERMANENT
ACCESS FOR EVERYONE IN TH82
PUBLIC.
U$OSE ISçó THE 1998 LAUNCHED
(&#Oyó
ONE OF THE LONGEST STANDING
OFO5f
PROFILES IN SCIENCE AND I'M SURE
THERE WILL BE A ANNOUNCEMENT
LATER TODAY BUT WE ARE GLAD TO
REPORT THAT THIS PROFILE WAS
RELEASED YESTERDAY#
IN SCIENCE ALONG WITH THESE
DOZENS OF OTHER WONDERFULuqUq
PEOPLE.
THE RESOURCE INCLUDES
ANDD,#xñ UNPUBLISHEDeIWy ITEMS,
BOOKS,
JOURNAL,, DIARIES, PHOTOGRAPHS,
AUDIO ANDb
AND ONE COLLECTION INCLUDES THE
REPORTS OF THE SURGEONGâ=
GENERAL
PROFILES ACCOUNTED NOT ALL BE
INmFÓá
5$y
ANOTHER WONDERFUL RESOURCE IS
THE IMAGES IN THE HISTORY OF
MEDICINE DATABASE.
IT'S INTERESTING6z THIS
INFORMATION WAS DISTRIBUTED ON
l
REMEMBER THOSE IÂu
IN THE SHALLY 90s.
AND WE MADE THE LIST OF THESEq
Jz THE
IMAGES FIRST AV
INTERNET IN 1994.
THE TITLES AND INFORMATION ABOUT
THESE IMAGES WAS IN 1
IT AVAILABLE ONLINE.
TODAY IT HAS OVER 70,000 IMAGES,
PHOTOGRAPHS, GRAPHIC ARTS AND
RANGES FROM THE
15-TWIST>t>k÷:Pú4&@
CENTURY.
OBVIOUSLY PUBMED CENTRAL IS CORE
TO OUR EFFORTS TO PROVIDE
ACCESS, PERMANENT ACCESS TO THE
BIOMEDICAL INFORMAlMi2N AND IN
ADDITION, TO COLLECTING
[÷
THOUSANDS OF JOURNAL SYSTEM ASK
THEY ARE PUBLISHED AND MADE
AVAILABLE TO THE PUBLIC, WE HAD
SEVERAL BACK FILES PROJECTS TO
BRING JOURNALS BACK FROM VERSION
ONE AND THIS HAS BEEN A REALLY
BIG PROJECT.
WE STARTED IN;oR 2002 WITH WITH
MODEST EFFORT AT THE LIBRARY.
THE WELCOME FOUNDATION FROM THE
U.K. CAME IN WITH MONEY TO
SUPPORT THE SCANNING OF THESE
BACK FILES BECAUSE THE
THEY WERE IMPORTANT FOR CURRENT
SCIENCE AND HISTORICAL SCIENCE.
AND THAT EFFORT RESULTED IN THE
ADDITION OF WELL OVER A MILLION
ARTICLES TO PMC.
WE ARE HAPPY TO SAY5
HAS MOU WITH US NOW CURRENTLY IN
PLACE TO ARRANGE A GIFT OF
750,000 POUNDS WHICH WILL ALLOW
US TO ADD AT LEAST AND PROBABLY
MANY MORE 700,000 MORE PAGES
BACK FILES TO PMC.
SOME OF THE JOURNALS THAT WILL
BEçj
INCLUDES THEÅ
HEALTH, MENTAL HYGIENE, THE
JOURNAL OF PSYCHOLOGICAL
X
MEDICINE AND MENTAL HEALTH
PATHOLOGY AND THE ENDIAN MEDICAL
GAZETTE.a;c+x!$@
THESE SCANNED PAGES ARE ACCESSED
OVER 3.5 MILLION TIMES PER5Q7H
MONTH.
WE SA DIGITAL COLLECTIONS.
ALL 10,000 ITEMS CURRENTLY IN
DIGITAL COLLECTIONS ARE
AVAILABLE WORLDWIDE AND
POLITICAL PUBLIC DOMAIN.
IT IS
COLLECTIONS THAT COMPLIMENTS THE
PUBMED CENTRAL DIGITAL ARCHIVE
OF ELECTRONPpp
SO PUBMED CENTRAL HAS A GENERAL
ARTICLE AND DIGITAL COLLECTIONS
HAS MONOGRAPHS.
SO THIS DIGITAL2%
PHYSICAL MATERIALS THAT WE
DIGITIZE BUT IT IS ALSO A
REWX+e
GOOD EXAMPLE OF WHAT WE ARE
DOING WITH THE BORN DIGITALS.
SO THERE ARE
oi INGESTED
REPORTS THAT WILL BEA5o-!fÑ
INTO THE DIGITAL ARCHIVE THAT
THEY WON'T BE PRINTEDMñD
BE ABLE TO
DIGITAL COLLECTION.e1
#
IN 2010, WE zs
A GRANT FROM A FOUNDATION THAT
#ñt MEDICAL
HELPED TO STEP THE
HERITAGE LIBRARY.
THIS LIBRARY IS A DIGITAL
CURATION COLLABORATIVE AMONG
AMERICA'S LEADING HISTORY OF
MEDICINE COLLECTIONS TO PROMOTE
FREE AND OPEN ACCESS TO QUALITY
MATERIALS IN THE HISTORY OF
MEDICINE.
NL346789 COP CONTRIBUTED OVER
10,000 ITEMS FROMK
COLLECTIONS, ELECTRONICALLY, TO
THEt( MEDICAL HAIR TAN LIBRARY
AND
THEY DATE FROM 16 10-1923.
YOU MIGHT REMEMBER THAT NUMBER
OF 10,000 THEY ARE TH5
ITEMS IN OUR DIGITAL COLLECTION.
SO IT IS A VERY GOOD EXAMPLE OF
A PAPER WITH OTHER ORGANIZATIONS
WHERE WE MADE THE INFORMATION
EVERYBODY THROUGH THE
INTERNETd6Bh
ARCHIVE.
AS AN INSTITUTIONAL MEMBER OF
THE NATIONAL DIGITAL STEWARDSHIP
ALLIANCE, NLM SUBSCRIBE TO THE
NATIONAL AGENDA4(Q7ñ FOR
STEWARDSHIP.
ANOTHER EXAMPLE OF PRESERVING
AND COLLECTING FITS INTO THE
COUNTRY'S EFFORTS.
NOTICE THE EMPHASIS ON THE MOST
RECENT REPORT ON PRESERVING FOUR
Sñig-l
AREAS INCLUDING WEB AND SOCIALO
MEDIA WHICH IS OF COURSE PART OF
OUR BORN DIGITAL CULTURAL
HERITAGE.
SO WHAT ARE WE
COLLECTING AND ARCHIVING?
WE HAVE AFTER EFFORT TO OBSERVE
OURxD CULTURAL HERITAGE AS IT
OCCURS WHETHER OR NOT IT IS
INSTITUTIONAL WEBSITES, BLOGS,
PROFESSIONALS, PATIENTS OR
HEALTH ADVOCATES.
I DON'T KNOW HOW MANY OUm YOU
EVER LOOKED FOR A LINK THAT
TIME YOU GOT IT, THE LINK WAS
GONE OR IN A PUBLICATION?
THIS IS AN EFFORT TOu AE
PRESERVE
THAT DIGITAL HERITAGE AS IT
OCCURS ANDñ
THE FUTURE.
SO WE HAVExD A GENERAL HEALTH
AND
MEDICINE BLOGS cE
INCLUDES BOTH THE PATIENT AND
THE
AND ALSO WE HAVE SUBJECT AREAS
/Ñm0
ONE OFc
COLLECTION AND WE ALSO ARE
DIGITAL STEWARDSHIP
RESILVZq÷ykjíñ
CREATED THIS COLLECTION OF
DISORDERS OF THE DEVELOPING AND
AGINGb
ON TWO DISORDERS AUTISM AND
ALZHEIMER'S.
AND THOSE COLLECTIONS HAVE
ANYTHING FROM GOVERNMENT TO
NONPRTÑñ TO PERSONAL STORIES.
WE CREATED A EBOLA COLLECTION
STARTING VERY LATE LAST SUMMER
WHICHOi?
NCBI, OUR OWN RESOURCES.
DOCTORS WITHOUT BORDERS, AND
NEWS OUTLETS, GOVERNMENT
OUTLETS.
SO IT BRINGS ALL THAT WILL
INFORMATION TOGETHERóz#u
SNAPSHOT WAY TO HAVE IT FOR
PEOPLE TO LOOK .cdz AND SAY WHAT
WAS GOING ON WITH THE EBOLA AND
WHAT WE WERE WE DOING?
AND NOT TO BE THIS THE THE
SHUMAKER'S CHILDREN, WE ARE ALSO
COLLECTION OF
OUR
CREATING A WEB5
OWN WEBSITES.
WE ARE NOT COLLECTING THE
INFORMATION ON THE BACK END,3vx8
THE
UNDERLYING INFORMATION.
WE HAVE GOT WAYS TO DO THAT.
IT'S NOT THAT WE ARE NOTP,
COLLECTING THIS.
BUT THIS IS PARTICULARLY
SNAPSHOTTING WHAT DO OUR
WEBSITES LOOK LIKE OVER TIME SO
THAT WE'LL HAVE THAT ARCHIVE TO
BE ABLE TO PROVIDE.
SO AN IMPORTANT PART OF
PRESERVATION AND PROVIDING
PERMANENT VEIL BUILTY IS
DISSEMINATION.
AND ONE OF THE MORE INTERESTING
WAYS WE HAVE DONE THAT IS TO
PARTICIPATE INwóO4 SHARED
EFFORT ON
GETTING OUT INFORMATION IN
LINKED DATA.
SO, THE EASIEST WAY FOR ME TO
DESCRIBE LINK DATA IS THE WAY
OUR STAFF DID HERE IS TO SAY IT
FACILITATES DISCOVERY AND
WE7ó
HEADINGS AS LINK DATA AND WE
WERE LOOKING ONA4
USING THAT.
IT'S A BETA.
FOLKS ARE TELLING US WHAT IS GOD
ABOUT IT AND WHAT ELSE THEY
COULD USE AND WE INTEND TO DO
MORE OF THIS.
THIS IS JUST ONE EXAMPLE OF THE
KIND OF DISSEMINATION WE DO.
LONG BEFORE AN ADMINISTRATION
DECIDED DATA.GOV SHOULD HAPPEN
AND THE GOVERNMENT SHOULD
BEt61,y
RELEASING DATA, WE HAVEL'%$
RELEASING MEDLINE, WE USED TO
MAGNETIC TAPES AND
RELEASE IT ONK:
NOW WEr
OF WAYS.
WE HAVEsgSlq A COM LET LIST
AVAILABLE
TO ANYONE WHO WANTS TO USE OUR
GOVERNMENT INFORMATION IN THEIR
RESEARCH AND PUBLIC PRODUCTS FOR
CLINICAL APPLICATIONS, HOWEVER
THAT YOU I WANT TO DO IT AND
THEY CAN FIND THAT INFORMATION
RIGHTY5y
COMING BACK AROUND TO OUR
HISTORY, AND DISSEMINATION, ONE
O
WAS THE INDEX CAT.
I'M THEME SAY THAT OUR HISTORY
OF MEDICINE DIVISION WORKING
WITH OTHER INw3 THE LIBRARY
OPERATIONS AND OUR COMPUTER
SUPPORT AREA, RELEASED THE INDEX
CAT, RERELEASED IT BECAUSE
OBVIOUSLY IT WAS
PRINTED PUBLICATIONS MANY
AGO.
THEY RELEASED THESE 3.7 MILLION
CITATIONS SPANNING SIX CENTURIES
AND I THINK IT'S A GREAT EXAMPLE
OF HOW THE INFORMATION WE CREATE
uI2eEMXy
IS THE USEABLE,5
FOR THE LONG TERM.
I HOPE SOME OF YOU HAVE THIS
BEAUTIFUL BOOK HIDDEN TREASURE,
IN YOUR OFFICE OR ON YOUR÷;ñ/
COFFEE
TABLE SOMEWHERE.
IN THE FORWARD, LINDBERG TELLS
US SOMETIMES WE NEED TO SEE AND
HOLD THE ORIGINAL FOR
INTELLECTUAL WORKS ANDa
THE GROAT MICHAEL, WHERE THEY
SAY THESE MATERIALS CAN SPEAK TO
US, CHARM US, REPULSE US AND
AMAZE US
US.
WE CERTAINLY THINK THATIS TRUE
FOR THE HIDDEN TREASURES OF THE
NATIONAL LIBRARY OF MEDICINE.
BUT I THINK YOU'LL AGREE THAT
OUR HISTORY,<hU
RANGE PLANS AND PROGRAMS SUPPORT
OUR ROLE IN PRESERVING THIS
COUNTRY'S CULTURAL HERITAGE.
BUT JUST THE FIRST STEP OF
PRESEVERRING IT ISN'/OM
ENOUGH AND THAT WE ARE MEETIU,G
OUR
READ AS PRESERVED AND AVAILABLE
TREASURE.
SO THANK YOU AND I'LL WELCOME
YOUR QUESTIONS.
[ APPLAUSE ]év
>> [ OFF MIC ]
7; A BENEFICIARY O
F THE TRAINING
PROGRAM AND AS A FELLOW AND ONE
OF THESE PEOPLE WHO LOVE THE
INDEX CAT.
PROBABLY ONE OF THE FEW WHO DO,
I REALLY THINK THE JOB YOU DO IS
GREAT.
REALLY[
THE QUESTION I HAVE TOO S WHAT
HAPPENS AFTER 2030?
[ LAUGHS ]
>> WELL, WE ARE WORKING ON
ONE THING WE ARE REALLYa
ON IS NEEDING TO COLLECT LESS OF
THE PRINT.
WE HAVE DONE A FEW STUDIES AND
WE ARE LOOKING AT MORE
COMPREHENSIVE STUDIES BUT ONE OF
THE THINGS WE ARE LEARNING IS
PRINT AND ONLINE ARE NOT
EQUIVALENT.
WE KNOW
áQ WEuW
A COPY BUT YOU COPY THEY ARE
GIVING US MAY NOT INCLUDE ALL
THE INFORMATION.
SO WE ARE WORKING ON WAYS
PRESERVE THE
áz
PUBLISHERS WHEN THEY CHOOSE
NOTRçelÑ
TO PARTICIPATE IN
THINGS.
WE ARE LOOKING ATaúO
LOCKS ANDJé THOSE SORTS OF
THING
AND HOW THOSE PARTNERSHIPS MIGHT
WORK.
>> [ OFF MIC ]
>> ONE OF THE TEXTBOOKS SAID IF
YOU&Pç[ PURCHASEAZ3
ONE THING AND THEN IF YOU GET
THE E8
ELSE.mL
SO --
>> [ OFF MICS7 ]
WHAT PER SENT ANNUAL OF THOSE --
JUST A VERY BEING ROUGH FIGURE.
>> SO WE SAY WE OWN 18 MILLIONäñ
ITEMS, THAT INCLUDES VERY
EXTENSIVE ITEMS FROM(RR+ES
AND MANUSCRIPTS.#
SO, AR AND HE WAS MANUSCRIPTS.
SO WE HAVE WAYS OF COUNTING
THOSE THAT MAKE IT LOOK LIKE
WEA.
HAVE A LOT.
SO WHEN WE MOST
REPORTED OUR DIGITIZED TITLES TO
THE ASSOCIATION OF RESEARCH
LIBRARIES, ANOTHER GROUP I
DIDN'T HAVE TIME TO MENTION, WE
INCLUDED THE 10,000 OR SO BOOKS
IN DIGITAL COLLECTIONS AND THE
MATERIALS:ó
W
MENTION.
THE BOOKSHELF IS ANOTHER WAY WE
ARCHIVE MATERIALS.
AND Ipv/Iu TO SAY THAT NUMBER
ISIá!ecr1q
14 OR 16,000.
>> [ OFF MIC ],Squñ
24% OF MEDICAL JOURNALS WERE
DIGITIZED, 24% --Sñ16v YOU SAID
WAS
AVAILABLE FREE?
#es
>> YES, THEqlfBASICALLY, WE HAVE
ELECTRONIC
THANrJtÑ 50% OF OUR COLLECTION.
FAR LESS.
SO WHAT WE SHOULD DO IS GO BACK
1ç ESTIMATES.
AND GET
THE NUMBER CREEPS
HAVE VARIOUS PROJECTS AND SO
FORTH AND OF COURSE, AS WE BEGIN
TO ACQUIRE MORE THINGS
z
ELECTRONICALLY AND ADD
THE COLLECTION, THE[
IÑ SIMPLY BECAUSE
IS GOING TO GO UPf
LESS GOING TO COME IN IN THE
OTHER FORMAT.
BUT IT IS:é $ ABSOLUTELY TRUE
AT
THINGS IN THE NLM COLLECTION
THAT ARE NOT READILY ACCESSIBLE
IN THE ELECTRONIC FORM.
NOW SOME OF THEM MIGHT BE
ACCESSIBLE SOMEWHERE BECAUSE
J#y
SOMEONE ELSE DIGITIZED THEM AND
ONE THING THAT NLMX;k#z IS VERY
GOOD
AT AND WASG
IS WE HAVE A VERY,xoqg(Ñ HIGH
PERCENTAGE OF OUR
CAN GETE;!ñ
A
h
WHERE YOUc
MACHINE READABLE AVAILABLE
DESCRIPTION OF THE ITEMíçcá SO
YOU
CAN RETRIEVE SOMETHING ABOUT IT.
6mnz LIKE THE 25 MILLION
5 WHATEVER.u1]z
THINGS INQ
Wç THAnES/Jjurñ WE
"1L
SO, IÑq-Ñ THINK=
LONG AGO,x
DR. WAS
HERE AND HE WAS
DISCOVERED THAT PEOPLEw#(Q FEEL
THAT
pS[THINGS#"p
EXIST.
THEY2f)(
ñ
AND+csRÑ ACTUALLY, HE WAS!Ñ
A0uRs
ENCOURAGEMENT TO US ANDcKuYQP
FORWARD:cY
CONVERT THEnlaçTI
WE NOW GO BACK TO WHATEVER IT
IS, 46 OR 45 OR SOMETHING LIKE
THIS.
ANDPV DR. BANK WAS SITTINGú
AIp
THERE, IT WAStÑiwM:Uz HAD
66 ON.NgimÑ
S
AND I THINKa7;2W WE HAVE GONE
BEYOND
THAT.
IT USED TO/f)?ÀvçEí[p BE IT
DIDN'T EXIST
IF
YOU COULDN'T RETRIEVE IT IN"33÷
MEDLINE OR IN SOME ELECTRONIC
DATABASE.
IT.
AT LEAST
I'M AFRAID FOR A LOT OF PEOPLE,
IT DOESN'T
CLICK RIGHT FROM THERE3n0ót AND
GO
SEE AN ELECTRONIC COPY OF IT.
>> SHOULD WE DEVELOP A( PLAN TO
DIGITIZE EVERYTHING?
>> MY FEELING IS, IF YOU LOOK
DOWNéñÑTHEjíT>L
IN MY VIEW, WE SHOULD HAVE A LOT
MORE DIGITIZED THAN IS
DIGITIZED.
WHETHER YOU COULD SET THE
PRIORITIES ANDzEñ YOU MIGHT GET
DOWN TO THE POINT WHERE YOU
WOULD SAY MAYBE IT'S COST
EFFECTIVE?
ISN'T THERE, BUT AS A REGULAR
GOAL, SURE.
F"քl8"
>> [ OFF MIC ]B
>> DR. WALKER, WE HAVE THE SAME
ISSUE THAT
OF MEDICINE HAS AND WHILE WE HAD
A VERY LONG(d
HISTORY IN COLLABORATING, IT IS
MORE CRITICAL NAN EVER IN
THIS"Ih
HYBRID WORLD, AS WE CAN SE FROM
THE PHOTO OF IRON MOUNTAIN, ALL
OF THAT EARLY MATERIAL HAD TO BE
MICROFILMED AND LOOKING AT HOW
WE[x PRESERVE THE BORN DIGITAL
THAT ISç
CONSIDERING AS WE TALK IN THE
PROFESSION, ARE THEREjF WAYS
THAT
WE CAN GO TO THE'Oc
CREATORS AND ARE THERE INGS
THE MAJOR DATA CREATORS CAN DO
THAT WILL FACILITATE THEçí
b ACCESS?
PRESERVATION ANDL
>> AND I THINK THATZv THE
LIBRARY
OF CONGRESS AND ALSO THE
BRITISHbfDúñ
LIBRARY,3T
z
IT WAS THEIRñ7
FORMAT OF THE JOURNAL ARTICLE,
ARCHIVE FORMAT THAT WAS POSED
AND USED IN PUBMED CENTRAL82ó@!
REALLY HELPED TO TURN THAT INTO
A DEFACTO STANDARD.
SO IN THE ARTICLE.é#k AREA, WE
MADE
GREAT STRIDES I¤9ó THE1M
VERY HIGH PERCENTAGE OF
THEMY!F(m÷1XQ
ELECTRONIC ARTICLES THAT ARE
PUBLISHED TODAY,ÑiB. BASICALLY
THEY
WILL OUTPUT THOSE IN STANDARD
FORMAT AND." THEREFORE PEOPLE
CAN
DESIGN TO THAT FORMAT AND WE ALL
CAN WORRY TOGETHER ABOUT HOW4'
MIGRATE LARGE VOLUMES OF THAT IN
A SINGLE FORMAT WHICH IS A MUCH
EASIER PROPOSITION THAN IF EVERY
JOURNAL WAS IN THExD SLIGHTLY
DIFFERENT FORMAT.
SO THAT WAS A HUGE SUCCESS.
BUT IT'S THE SAME ISSUE THAT
GLENN WAS TALKING ABOUT TODAY IN
TERMS OF THEIr
IF YOU
CONVERGE ON STANDARDS THEN
THEE<x
PRESERVATION ASPECTS OF THIS
WHILE STILL'÷
FORMIDABLE ARE MUCH LESS THAN IF
YOU'RE LOOKING AT EVERY LITTLE
PIECE OF DATA OR EVERY FILE AND
SAYING, WHAT IS THIS SPECIAL
CONVERSION ASPECTS OF THIS
SMALLnuñP=Ñ
THING.
>> [ OFF MIC ]Ñi
HE SAID IT WAS BACK INxÑ]dD
WITH THE BOOKS COULDN'T TALK TO
EACHO
IS THAT WHATA
>> WHAT WE'RE GOING TO DIGITIZE?
ONE OF THE THINGS, DO EVERYTHING
THAT IS -- BUT I'M WONDERING IS
THAT VALUABLE VERSUS WHAT IS THE
DESCRIPTION OF WHAT THAT ITEM IS
AND IF YOU HAVE PEOPLE TALKING
ABOUT THOSE ITEMS THAT YOU</
GET'lnñ AHig OF, IS THAT A
FAIRÑi
SURROGATE FOR THE ACTUAL PIECE
ITSELF?
BECAUSE YOU THEN BUILD ON
HISTORY OF HOW PEOPLEç@úmz WERE
USING
THAT
>> THAT IS THE FORMAT TELLING
YOU SOMETHING ABOUT THE USE AND
WHEN YOU CHANGE THAT FORMAT, OR
EVEN IF YOU PUSH PEOPLE INTO
STANDARDIZING, IF YOU LOOK AT
MEDICAL TEXTBOOKS OF THE LAST 15
YEARS, HAVE YOU CALL OUT BOXES
AND ALL KINDS OF ENTERTAINING
THINGS THAT ARE A BLEND BETWEEN
THE ABILITY TO PRODUCE AN ONLINE
THAT WILL OPEN SOMETHING UP, AND
AN EFFORT TO GIVE A STUDENT A
TEXTBOOK.
AND IT TELLS YOUg'-k SOMETHING
ABOUT
HOW MEDICINE IS BEING TAUGHT AND
LEARNED.
ñ
AND IF YOU SOLVE THE PROBLEM
OFw'
2030, OF PUTTING THIS ALL IN ONE
FORMAT SO THE TEXTBOOK AND THE
CURRENCIESIL McDERMOTT IS IN
THEt( SAME FORMAT, HAVE YOU JUST
TAKEN AWAY A HUGE PIECE OF
CULTURAL HISTORY OF HOW MEDICINE
WAS LEARNED.
SO WE HAVE GOT TO FIND WAYS TO
PRESERVE THE ORIGINAL AND THE
INFORMATION.
RECORDS OF KNOWLEDGE ARE MUCH
MORE ROBUST THAN JUST THE
CONTENT.
>> YOUR ORIGINAL -- INH@
ORIGINAL CHARGE, IT SAID IN ANY
LANGUAGE.
DO YOU STILL DO STUFF IN ANY
LANGUAGE?
>> WE ENDEAVOR TO COLLECT THE
ENTIRE RESEARCH.
>> AND INM@Y
MEDICAL PUBLISHING HAS MADE THAT
EASIER FOR US THAN IT ONCE WAS
BECAUSE IT USED TO BE." THAT
THERE
WERE MANY MORE SUBSTANTIVE
ORIGINAL REPORTS OF BIOMEDICAL
RESEARCH AND WHAT HAVE YOU,
MEDICAL RESEARCH, THAT WERE IN A
WIDE ARRAY OF LANGUAGES, MUCH
WIDER THAN WHAT YOU GET NOW
BECAUSE ENGLISH IS KIND OF
INVADED THE
SO, WE STILL DO IT.
IT'S IN THE SENSE THAT WE ARE
NOT SAYING WELL, GEE, WE WON'T
TAKE IT BECAUSE IT'Szi
OR ARABIC.
BUT THERE IS LESS THAT NEEDS THE
.v OF
SCOPE CRITERIA OF THE KIND
MATERIAL THAT WE FEEL WE SHOULD
BE COLLECTING THAT ISe1
PUBLISHED
IN SOME OFnñEñ THIS MORE
LANGUAGES.
>> AND THE OTHER QUESTION IS,
THERE IS INSTANCES WHERE PEOPLE
DIGITIZED THINGS AND PUT
THEMy=Buñ ON
A MEDIUM WHICH 10 OR 15 YEARS
LATER YOU CAN'T FIND READERS FOR
AND THINGS LIKE THAT.
HAVE YOU HAD TO REDIGITIZE STUFF
THAT HAD ALREADY BEEN DIGITIZED
z WE HAVE TO REPRESERVE.
$éc.r
IN SOME FORM?
SO WE PUT OUR FILMS ON TO BETA
CAM AND WE EXPECT TO HAVE TO
MIGRATE THAT BUT THE THINGS I
JUST TALKED ABOUT, WE HAVE BEEN
ABLE TO MIGRATE FORWARD SO FAR
BECAUSE THEY ARE FAIRLY NEW, 10
OR 15 YEARS.
BUT WE HAVE MEDIA IN OUR STACKS,
HALF INCH VIDEOS, 16 MILLIMETER
FILM, A LOT OF AT RISK MATERIALS
THAT"
>> [ OFF MIC ]P/
[ LAUGHS ]
>> SO BESIDES THEt( ARCHIVEIkypv
ORIGINAL FORM JOURNALS AND
PUBLICATIONS THAT YOU PRESERVE
OR SCAN AN IMAGE, IS PUBMED
CENTRAL THE MAIN HEDGE AGAINST
TIMELINE PUBLISHER GOING OUT OF
BUSINESS AND&3b
ON THERE?
>> THAT IS SOMETHING THAT FOR
THOSE THAT ARE DEPOSITEDFa6L
THERE,
IT ABSOLUTELY IS.
OTHER HEDGES THAT ARE BEING
DEVELOPED IN THE
COMMUNITYRS BROADLY?
INTERESTED IN COLLABORATING
WITH.
>> THEó%;Fñ EVENT YOU DESCRIBED
WOULD
BE A TRIGGER -- --
>> AND WU WE ALSO HAVE CALLED
UPON TOaY2UV(UQ THINGS BEFORE
THEY DISAPPEAR WHEN
SOME PUBLISHER WOULD SAY, WELL,
WE ARE MIGRATING TO THIS
PLATFORM AND CERTAIN MATERIAL
WAS PREVIOUSLY AVAILABLE ON
THEIR OLD PLATFORM AND THEY
DISCOVERED THAT IT WAS GOING TO
COST THEM TOO MUCH MONEY TO
CONVERT THIS STUFF SO THEY SORT
OF DECIDED THAT MAYBE THE FIRST
10 YEARS OF THAT JOURNAL THAT IT
WAS ONCE ONE OF THEIR JOURNALS
AND THAT 10 YEARS IS GONE OR
MIGHT BE GONE.
DISAPPEARING.
AND WE HAVE A LOT OF FRIENDS IN
THE FIELD SO WE TEND TO HEAR
FROM PEOPLE WHEN THESE STAD
STORIES ERUPT AND THEN WE GET AN
INQUIRY.
IF WE CAN GET PERMISSION, WOULD
YOU PUT THIS IN PUBMED CENTRAL?
AND USUALLY THE ANSWER IS]?%
WE HAVE DONE THAT ONE OR TWO
CASE WHERE IS WE DID THAT.
>> THERE IS ANOTHER IMPORTANT
PART OF THE ANSWER TO
DR. WALKER'S QUESTION OF WHY NOT
DANGER TIES EVERYTHING.
IN ADDITION TO THE POINTS THAT
DALE SMITH MADE, COPYRIGHT IS A
çz HUGE PART OF ANY DIGG
BIG3
>> SO:x&g MUCH OF THIS
DISCUSSION
HAShT
COMMERCIALLY-PRODUCED THINGS.
AND IT'S BEEN PRODUCED
COMMERCIALLY, AFTER 1923, YOU
MAY NOT HAVE THE -- RIGHTS OWNER
CONTROLS COMPLETELY WHETHER
THAT -- YOU COULD DIGITIZE IT
HERE.
BUT YOU COULDN'T USE IT.
SO, WE LOOK AT THAT IN OUR FIRST
FOCUS IS ON NOT JUST THE -- WHAT
IS THE STUFF THAT IS FREE OF
COPYRIGHT OR ARE SURE IS
ABSOLUTELY UNIQUE TO OUR
INSTITUTION?
WHICH FOR US, ENORMOUS TROUBLE
jJj
CALLED USDA PUBHkX
BECAUSE IN A SOCIETY -- IN A
HISTORICAL TERM, PRIOR TO ABOUT
1960, THE FEDERAL GOVERNMENT9f&ú
WAS
THE PUB SHER OF THE RESEARCH.
THAT IS PRODUCED.
IN THE LATE 50s IT MIGRATED TO
GOING TO SCHOLARLY PEER-REVIEWED
COMMERCIAL JOURNALS.
THERE IS ENORMOUS TREASURE
TROVES OF REALLY GOOD SCIENTIFIC
RESEARCH IN OUR COLLECTIONS THAT
WEREqBlÑ ABLE TO DIGITIZE
BECAUSE
IT'S USDA.
AND THAT'S WHEREok WE START.
>> WHERE DO WE STAND ABOUT --
[ INDISCERNIBLE ]
HAVE WE DECIDED WE DON'T NEED
IT?
IT SEEMED TO ME YOU'RE VERY
SUCCESSFUL IN AMERICANA
COLLECTION.
IS THAT CONTINUING?
DO YOU VIEW IT AS AU
>> IT IS CONTINUING.
ALTHOUGH THE ORIGINAL FUNDING
THAT CAME
FOUNDATION, WEpg%O HAVE GONE
THROUGH
THAT FUNDING.
BUT WE HAVE EMBARKED FOR
DIGGIZATION ON NO COST
CONTRACTS.
SO WE HAVE A CONTINUOUSLY
RUNNING RFP
PARTIES TO SUBMIT
DIGGIZATION.
WE HAVE SOME PRINCIPLES FORÑ4ljñ
THIRD PARTY DIGGIZATION.
WE WILL ALLOW AN EMBARGO PERIOD
UP TO THREEc
SO WE HAVE -- THAT'S BEEN GOING
WE HAVE FIVE MAJORM
SO THAT SEEMS TO BE A GOOD
APPROACH FOR CERTAINpkÑgñ TYPES
OF+!u
COLLECTIONS.
>> OFF MIKE NIKE.
>> SOREEjF CORE, THAT COLLECTION
IS AT THE LIBRARY OF CONGRESS
BUT DO YOU MEAN IN TERMS OF
PRESEVERRING THAT FOR THEúBpe
FUTURE?
< WONDERFU'"LN5I
>> I THINK IT WAS AX
IDEA.
IHt ATTRIBUTE THE WHOLE THING
TO
MAYBE IT'Sc4Pv NOT RIGHT.
>> SO WE HAVEUR2S TAKEN ON THE
RESPONSIBILITY FOR PRESEVERRING
THAT COLLECTION.
>> IT'S
WORLD IS GOING TO BE IN 10
YEARS.
AND THE STORY FOR THIS KIND OF
THING, THAT'S Aá IT.
AND SOMETHING V
HAVE TO EXPECT AND(]x WARRANT
AND
NEED.
WE DON'T HAVE TOú
IN
SO YOU LIKEbí4ñ THE THINGS THAT
YOU
HAVE DONE, THE INNOVATIONS YOU
BROUGHTw3 FORWARD SO FAR AND
WHAT
IS YOUR6
>> THERE IS SO MUCH MORE?ÇIy
TOÑit
SO OUR NEXT 10 YEAR STRATEGIC
PLAN --
EVERYBODY ON
>> JUST TO REMIND
THE BOARD, AND YOU PROBABLY
f THIS.
ALREADY KNOWkS
AS JOYCE WELL6$@íwui3
AND ITS PREDECESSORS HAVE BEEN A
FACT ON THE GROUND, A PRESENCE
Jjt
A VERY
IN THIS SPACE FOR
TIME.
AND AS A RESULT, THE ECOSYSTEM
HAS ADJUSTED AROUND IT.
SO, IT'S LIKE ANY OF THESE
INSTITUTIONS THAT HAVE HAD A
PIECE OF THI*pñ3L J
RESPONSIBILITY.
ESSENTIALLY YOU END UP IN A
SITUATION WHERE THERE IS FOR
MANY OF THE ITEMS THAT WE HAVE
COLLECTED, THERE IS REALLY NO
BACKDROP.
NO OTHER PLACE.
BECAUSE EVERYONE ELSE SAID GOOD,
THEY ARE TAKING CARE OF THIS AND
WE KNOW THEY HAVE A GREAT PLAN
AND THEY ARE DOING ALL THIS
WONDERFUL WORK.á*
SO, SINCE THAT IS NOT OUR PRIME
RESPONSIBILITY, THAT IS THE
PLACE WHERE WE WILL TRIM OR GET
MORE SPACE IN OUR COLLECTION OR
IN OUR STACKS OR FOCUS OUR
COLLECTING SOMEWHERE ELSE
BECAUSE NLM HAS THAT COVERED.
SO, SO THE ADJUSTMENT OF THE
BOUNDARIES OF WHAT WE DO IS
SOMETHING
VERY, IN MY OPINION, VERY
JUDICIOUSLY AND CONSCIOUSLY
LOOKING AT THE
BECAUSE THEY HAVE THE REST OF
THE WORLD HAS ADJUSTED BASED ON
WHAT THEY ARE EXPECTING US TO
DO.
>> THE REST OF THE WORLD ISF"Sx
PRETTY DAMN SHAKEY.
WHEN(
JUGS
ON THE STAIRCASES.
AS DID TAIWAN.
BUT EVERYONE FELT, WE ARE
SECURE.
BECAUSE WE ARE IN A AVON PROOF
BUILDING.
FEEL MORE SECURE
EVERYTHING CHANGED BUT I DON'T0
>> I THINK IT'S TIME FOR A
COFFEE BREAK.
>>> SO I WILL INTRODUCE
OUR NEXT SPEAKER.
PROFESSOR AND CHAIR OF COLUMBIA
UNIVERSITY'S DEPARTMENT OF
BIOMEDICAL INFORMATICS AND
DIRECTOR OF MEDICAL
SERVICES FOR NEW YORK
PRESBYTERIAN HOSPITAL.
AND SENIOR INFORMATICS ADVISOR
AT THE NEW YORK DEPARTMENT OF
HEALTH.
HE ALSO SERVES AS DIRECTOR OF
NLM INFORMATICS TRAINING PROGRAM
AT@tñ COLUMBIA.
HE RECEIVED HIS MD THERE.
HE SAY BOARD CERTIFIED IN
TERPIST WITH DEGREES IN
CHEMISTRY, MEDICINE AND
BIOSTATISTICS AND A HUGE TRACK
RECORD OF ACCOMPLISHMENTS
DEVELOPING AND IMPLEMENTING AND
STUDYING INFORMATICS
INTERVENTION AND HAS A VERY
IMPRESSIVE PUBLICATION RECORD
OVER 250 ARTICLES.
HIS PUBLISHED RESEARCH IS VERY
WELL-KNOWN ENTERING 60th
YEAR AND HIS PROJECT STUDIES
GREAT, TIMELY, ELECTRONIC HEALTH
RECORD IN ORDER TO BETTER
UNDERSTANDn7c
PROCESSES CAUSE PROBLEMS IN THE
DATA.
SO TODAY, WE ARE GOING TO GIVE
US A TALK - DISCOVERING AND
APPLYING KNOWLEDGE AND CLINICAL
DATABASES.
>> THANK YOU VERY MUCH AND SO
FIRST IT'S AN HONOR TO BE HERE.
YOU SHOULD KNOW THAT IN OUR
FIELD IT IS AN HONORED TOUR
ASKED TO SPEAK HERE AND IT'S A
SPECIAL HONOR TO BE ASKED TO DO
THIS TODAY.
SO IN VIEW OF THE MULTI100
MILLION DOLLAR INVESTMENT, IF
YOU LOOK AT PECORRI IN ADDITION
TO NIH AND USING HEALTH RECORDS
TO ADVANCE HEALTH RECORDS AND
BEAMING, I WANT TO TALK ABOUT
ISSUES INVOLVED THERE.
I DON'T WANT TO WAVE MY HANDS
ABOUT HOW GREAT IT IS GOING TO
BE NOR THROW UP MY HANDS ON HOW
HARD IT WILL BE BUT BE CONCRETE
ABOUT THE ISSUES AND SHOW YOU
SOME OF THE SOLUTIONS.
THIS WORK WAS FUNDED BY AN RO1
6910, TITLE IS THERE.
AND ALSO PEOPLE FROM MY TRAINING
GRANT 7097.
SO, IN THE U.S., THERE ARE A
BILLION PATIENT VISITS PER YEAR.
YOU THINK WE COULD LEARN
SOMETHING FROM THAT.
IT COSTS US 2.5 TRILLION DOLLARS
TO PRODUCE THOSE DATA AND NIH AS
FAR AS I KNOW DOESN'T HAVE THE
MONEY TO REPEAT THE EXPERIMENT.
SO, WE GOT TO USE THESE DATA AS
BEST WE CAN.
WE HAVE KNOWN FOR DECADES THAT
THERE ARE PROBLEMS AS WAS
POINTED OUT IN 89, MUCH OF WHAT
IS IN THE RECORD IS FICTION.
AND I'M GOING TO GO INTO DETAIL
ABOUT WHAT THAT MIGHT MEAN.
WHEN YOU READ AN ARTICLE ABOUT
USING ELECTRONIC HEALTH RECORD
DATA FOR RESEARCH, THEY POINT TO
LACK OF PENETRATION OF EHRs
AND WE MADE A HUGE LEAP FORWARD
WITH THE HIGH TEMPACK, 30
BILLION DOLLARS GETTING 60%
USAGE.
STANDARDS ARE A IMPORTANT
PROBLEM BUT WORKING ON THAT FOR
YEARS.
AND PRIVACY, HARD PROBLEM BUT I
CAN ENVISION IT WON'T BE A
PERFECT ANSWER, WE'LL DO
SOMETHING, THE HARD PROBLEM IS
THE CONSULT QUALITY OF THE DATA
AND THE BIAS IT PRODUCES.
SO I'LL GO THROUGH THAT IN MORE
DETAIL.
TO THOSE WITH A MEDICAL
BACKGROUND, I ASKED THE MEDICAL
90s I TEACH THEM WHAT IS
PERRLA MEAN?
AND THEY TELL ME PUPILS EQUAL
ROUND REACTIVE LIGHT IN
ACCOMMODATION.
I ASKED YOU WHAT IT MEANT NOT
STOOD FOR.
THE SAVVY ONES START TO THE
LAUGH A LITTLE BIT BECAUSE THEY
KNOW WHEN A DOCTOR WRITES PE
ARE.
RLA IN THEIR PHYSICAL EXAM, IT
MEANS THEY LOOKED IN THE
DIRECTION OF THE PATIENT THAT
THE HAD A PAIR OF EYES AND THEY
WERE PERRLA.
SO THAT SAY WOMAN WITH ONE EYE
AND A PROSTHESIS.
SOYY SAID HOW MANY PEOPLE IN MY
RECORD ARE PERRLA WITH ONE EYE
IS%bxku IN MY RECORD?
ONLY TWO% OF THE PATIENTS WITH
ONE EYE ARE LISTED AS PERRRLA
BUT ANOTHER 8% IS A PERRLA ON
THE LEFT OR RIGHT.
WHICH IS A MISUSE OF THE TERM.
AT LEAST I UNDERSTAND WHAT THEY
MEAN BY IT.
SO WHAT IS IMPORTANT IS WE WANT
TO KNOW WHAT IT MEANS IN THE
RECORD NOT JUST WHAT IT STANDS
FOR.
DATA ARE MOSTLY MISSING BECAUSE
YOU'RE SAMPLED WHEN YOU'RE SICK.
WHEN SOMEONE TELLS YOU HOW MANY
MILLIONS OF PATIENTS THEY HAVE
IN THEIR RECORD, ASK THEM HOW
MANY HAVE A SINGLE POINT.
YOU CAN NOT DO MUCH RESEARCH ON
A SINGLE POINT.
THERE IS NO CHANGE.
SO A LOT OF WHAT IS IN THERE --
AND THE DATA TEND TO BE
CLUSTERED.
THAT MIGHT BE PATIENT ADMISSIONS
WITH TIME AS AN OUTPATIENT.
THE DATA ARE NOISY.
THIS IS REAL FROM A MEDICAL
RECORD 36-YEAR-OLD MAN,
27-YEAR-OLD WOMAN.
I GUARANTEE THAT IS NOT ALL
TRUE.
AND THEN WHAT IS THE WORST THING
ABOUT THAT?
WITH CUT AND PASTE?
ONCE THIS HAPPENS, EVERY RECORDS
AFTER THAT HAS THE SAME MISTAKE.
SO AS YOU KNOW, WE HAVE ALREADY
INVENTED ETERNAL YOUTH.
A 56-YEAR-OLD WOMAN ONCE THEY
COME IN ONCE THEY STAY THAT FOR
THE REST OF THEIR TIME FROM THE
HOSPITAL BECAUSE THEY CUT AND
PASTE THAT RECORD FORWARD.
SO WE HAVE THE TRUTH ABOUT THE
PATIENT, WHICH BECOMES A CONCEPT
IN SOMEONE'S MIND WHICH BECOMES
THE ARTIFACT OF THE RECORD WHICH
WAS INTENDED TOO BAD READ BY A
PERSON BUT WE SHORT CIRCUIT IT
TO CREATE A COMPUTABLE
REPRESENTATION AND ERRORS CAN
OCCUR ANYWHERE ALONG THE WAY.
THE DATA ARE COMPLEX.
A LOT IS IN NARRATIVE FORM.
WE NOTICED LATELY DOCTORS ARE
TYPING INTO THE HEALTH RECORD
THE SAME WAY THEY TYPED INTO
THEIR CELL PHONE AND SO THEY
MAKE UP ABBREVIATIONS AS THEY
GO.
PEOPLE IN THE SAME FIELD EVEN
SOMETIMES HAVE TROUBLE
INTERPRETING IT.
THE GOOD NEWS HERE IS THAT
NATURAL LANGUAGE PROCESSING HAS
BECOME FAIRLY MATURE.
WHAT YOU SEE HERE IS A SUCCESS
SLIGHT INCREASE OF#8
YOU NOTICE THIS SAYS INTENTED TO
CHANGE DEGREE.
IT RECOGNIZES THIS IS NOT A
SLIGHT CONGESTION.
THIS IS A LIGHTbQ:4 INCREASE OF
A
LARGE CONGESTION.
THAT'S SUBTLE SO THESE SYSTEMS
ARE ABLE TO DO PRETTxw!b WELL.
HOW ARE THEY FUNDED?
BY THE NLM.
HERE IS IDEAL PERFORMANCE IN
THIS CURVE, THE GREEN ARE
DOCTORS RADIOLOGISTS AND
INTERNISTS, THE RED IS THAT
SYSTEM A SHOWED IN THE PREVIOUS
SLIDE CALLED MEDLEY INVESTED BY
CAROL FRIEDMAN FUNDED BY NLM.
THESE ARE LAYPERSONS AND THIS IS
LIKE A GOOGLE SEARCH.
YOU CAN SEE IT'S IN THE GROUP OF
CLINICIANS.
NEVERTHELESS, THE DATA ARE
HIGHLY BIAS.
MEDICINE A COMPLEX FEED FORWARD
NETWORK.
THE PATIENT IS SICK SO YOU
SAMPLE THEM AND MAKE AN
INTERVENTION THAT CHANGES THEIR@
STATE, THAT DECIDES WHETHER YOU
SAMPLE THEM FURTHER.
SO WHAT YOU'RE MEASURING IS
DIRECTLY AFFECTING HOW YOU'RE
MEASURING IT.
AND IT LEADS TO PROBLEMS LIKE
THIS.
SO THIS IS MY
ELECTRONIC HEALTH RECORD TO
REPRESENT OR RE-CREATE A FAMOUS
STEADY BY MICHAEL FINE IN THE
90s.
THE GREEN ISY IS VERTY AND THE
HEALTHIEST OF THE SICKEST.
THIS IS MORTALITY AND AS YOU GET
SICKER, YOU HAVE A GREATER
CHANCE OF DYING FROM COMMUNITY
ACQUIRED PNEUMONIA.
THIS HELPED TO DECIDE WHETHER
THE PATIENT SHOULD BE ADMITTED
FOR IV ANTIBIOTICS OR GO HOME.
SO I REPEATED THIS STUDY AND YOU
SEE THE HEALTHIEST PEOPLE ARE
DYING MORE OFTEN AS IF YOU
SHOULD BE A LITTLE BIT SICK IF
YOU WANT TO SAVE YOUR LIFE.
SO WHAT IS REALLY HAPPENING HERE
IS IF YOU COME INTO THE HOSPITAL
SERIOUSLY ILL, TO THE EMERGENCY
ROOM, AND DIE, IN THE EMERGENCY
ROOM, THERE IS NOT A TON OF
INCENTIVE FOR THE DOCTOR TO
SPEND A LOT OF TIME DOCUMENTING
YOUR SYMPTOMS IN THE HEALTH
RECORD.
SO IT1d1WILL SHOW THE DEATH
WITHOUT SYMPTOMS SO IT APPEARED
YOU WERE HEALTHY AND THEN YOU
DIED.
AND IF WILL BE IN THAT CATEGORY.
SO SOLVE THIS BY FILTERING
PEOPLE WITH THAT PROBLEM.
BUT THE FILTER, I HAD A COHORT
OF 19,000.
AND WHEN I FILTERED, I GOT A
COHORT OF
SO THAT IS SHOWN HERE IN PURPLE
AND IT WORKS.
THE FILTERING.
BUT, I KNOW IT WORKED BECAUSE I
HAD THE REAL ANSWER.
GENERALLY IN STATISTICS IF YOU
FILTER OUT 90% OF YOUR DATA YOU
YOU KNOW THERE IS BIAS THERE.
THIS DOESN'T WORK DIRECTLY.
DOCTORS USE THESE DATA TO CARE
FOR PATIENCE AND THEY DO A GOOD
JOB BY-AND-LARGE.
THE QUESTION IS, HOW DO WE GET
FROM THESE NAIVE OR THIS NAIVE
USE OF THE DATA TO MORE COMPLEX
USE OF THE DATA?
Zs WE DEINVOLVE THE TRUTH?
CAN]
A CT SCAN IS REALLY JUST A BUNCH
OF X-RAYJTÑ IN DIFFERENT
DIRECTIONS AND USES A MATH
FORMULA TO FIGURE OUT THE 3D
STRUCTURE.
CAN WE LOOK AT THE HEALTH RECORD
IN1SLkx NAIVE WAYS FROM
DIFFERENT
DIRECTIONS AND THEN GET THE
TRUTH?
THE STATE-OF-THE-ART TO DEAL
WITH THESE PROBLEMS IS TO
DEVELOP OR COME UP WITH A
PHENOTYPE.
SO HERE WE HAVE THE RAW HEALTH
RECORD DATA AND INSTEAD OF GOING
STRAIGHT TO THE EXPERIMENT, WHAT
WE DO IS DEFINE INTERMEDIATE
STATE CALLED THE PHENOTYPE SO WE
GO FROM THE RAW DATA TO
SOMETHING AND I'LL SHOW YOU
EXAMPLES TYPE II DIABETES.
THE PATIENT HAS A RASH OR
DRUG-INDUCED LIVER INJú
THEN I DO MY ASSOCIATION
EXPERIMENT AND SAY, IS THE DRUG
CAUSING DRUG INDUCED
LIVERRER:sçfñ
INJURY?
I SPENT SOME TIME IN THIS PART
GOING DOING THE QUERY FROM THE
RAW DATA TO PHENOTYPE.
THE A. I WOULDN'T LOOK FOR A
DIAGNOSIS CODE AND HEART ATTACK,
I WOULD SEE WHAT MEDICATIONS THE
PERSON GOT.
WERE THEY IN THE CCU?
MEDS?
AND LAB TESTS.
TRIPONE IN LEVEL.
THE PROBLEM IS, THIS IS TRUE FOR
DRUG INDUCED LIVER, MY POSTDOC
SPENT 6 MONTHS DEFINING THIS
PHENOTYPE.
IF YOU WANT IT TO BEM
TRANSPORTED
ACROSS MEDICAL CENTERS.
IF WE DO IT LOCALLY IT'S FASTER:
IF TOOK 6 MONTHS.
THAT'S A PARTICULARLY HARD ONE,
I ADMIT BUT PLUS AT THE END OF
THAT T DOESN'T NECESSARILY WORK
PERFECTLY.
THE QUESTION IS, WHAT CAN WE
AUTOMATE?
WHAT IS THE NEXT STEP AFTER
DOING THIS SIMPLE THING THAT WE
ÑkR
REALLY HAVE BEEN DOING SINCE THE
MID 1990S USING THIS APPROACH?
SO THERE IS SOMETHING I KIND OF
SOMEWHAT FACETIOUSLY CALL THE
PHYSICS OF THE MEDICAL RECORD.
AND THE IDEA IS TO STUDY THE
MEDICAL RECORD.
IT IS NOT THE PATIENT.
THE MEDICAL RECORD IS THE
RECORDING OF THE PATIENT.
WE NEED TO UNDERSTAND THAT
RECORDING, UNDO THE DAMAGE WE
HAVE DONE IN RECORDING AND THEN
KNOW MORE ABOUT THE PATIENT.
IN ADDITIO2mâñ WE AGGREGATE
ACROSS
UNITS AND THAT'S WHAT YOU DO IN
PHYSICS.
THIS IS GLUCOSE HERE.
THIS IS GREAT FOR CREATING AN
ARTIFICIAL PAN REESE OR WHAT
KIND OF MEALS TO EAT.
SO YOUéfsKÑ NEED TO HAVE
PREDICTABILITY.
THE AXIS IS FROM 6 HOURS, FOUR
HOURS AND TO OVER A YEAR IN TIME
BETWEEN TWO MEASUREMENTS FROM 4
HOURS.
THIS SCALES HOW MANY MEASURES IN
BETWEEN.
FROM 1-100.
WHAT WE SEE IS THAT IF IT'S NOT
MUCH TIME AND NOT MANY
MEASUREMENTS, IT'S HIGHLY
PREDICTABLE.
THAT MAKES SENSE.
THE NEXT THING I WAS STRUCK WITH
WHICH ISmb÷ OB CUT IN
RETROSPECT,
THIS RIDGE HERE AND THIS RIDGE
HERE AND THEN IT GETS BURIED IN
THE NOISE MY GLUCOSE TODAY IS
GOING TO BE PREDICTIVE OF MY
GLUCOSE AT THE EXACT SAME TIME
TOMORROW.
I PROBABLY WENT TO BED AT THE
SAME TIME AND HAD MEALS AT THE
SAME TIME.
SO MY METABOLISM WILL MATCH
ITSELF EVERY 24 HOURS MORE
PREDICTIVE THAN PREDICTING A
CLOSER TIME LIKE 12(A/H HOURS.
I'M GOING TO GO BACK TO THIS IN
A LITTLE BIT.
SO I DID A FIRST EXPERIMENT IN
THIS AREA WHICH IS TO TAKE 3
MILLION PATIENTS 21 LABORATORY
EF 50's 60 CONCEPTS DERIVED
FROMqéBP NOTES USING NATURAL
LODGE
PROCESSING.
THE IDEA WAS TO STICK IT INTO A
SIMPLE EQUATION.
IT'S PEARSON'S LINEAR
COREALATION.
SO I USE LINEAR INTERPRETATION
BETWEEN THE TWO AND THEN I
NORMALIZE PATIENTS SO THEY HAVE
A MEAN OF ZERO AND VARIANCE OF
ONE AND THAT IS TO REDUCE THE
INTERPATIENT AFFECT.
SO WHAT I'M DOING IS USING EACH
PATIENT AS THEIR OWN CONTROL.
AND THEN I JUST RAN THIS
EXPERIMENT.
SO ON THE SLIDES THAT FOLLOW,
THREE OF THEM.
WHAT WE ARE SHOWING HERE IS THIS
IS WHEN THE CONCEPT OCCURRED
LIKE THESE ARE DAYS BEFORE THE
LAB PRECEDED OR FOLLOWED THE
CONCEPT AND THIS IS A POSITIVE
AND NEGATIVE CORRELATION.
THIS IS THE FIRST CURVE
HYPONATREMIA MEANS LOW SODIUM.
THE DOCTOR WROTE IT IN THE CHART
RIGHT HERE.
WHAT HAPPENED TO THE SODIUM
BEFOREHAND?
THE SODIUM WAS LOW.
WHAT HAPPENED AFTER THEY90A>z
WROTE
HYPONEW TREME YOUNG IN THE
CHART, THE WENT BACK TOWARDS
NORMAL.
SO THAT MAKES SENSE.
WHEN I DID THIS EXPERIMENT, I
WAS EXPECTING SOME KIND OF VAGUE
LITTLE CORRELATION THAT SHOWED
THOSE TWO WERE SOMEHOW.
I DIDN'T EXPECT TO SEE A CURVE
THAT LOOKED LIKE THIS.
I SAID LET ME TRY HYPERNATREMIA.
THIS IS MIXING INPATIENT DATA,
OUTPATIENT DATA, ICU, 20
YEARSIVE DATA THROWING IT INTO A
SIMPLE EQUATION AND THE CODE IS
THIS LONG ONLY AND I'M GETTING
THESE CURVES.
SO LET'S SEE IF WE CAN SEE
ANYTHING MORE INTERESTING.
SO ALDACTONE, IS SHOWN HERE.
IT'S A POTASSIUM SPARING
DIURETIC.
SO DIURETICS GENERALLY MAKE YOU
LOSE POTASSIUM BUT THIS SAVES
IT.
WHO WOULD ORDER THIS?
A DOCTOR IF YOU COME INTO THE
DOCTOR WITH A LOW POTASSIUM ON
DIURETIC1VB7ú THEY MIGHT SWITCH
YOU
TO ALDACTONE.
SO WHEN YOU HAVE IT ORDERED
HERE, BEFOREHAND YOU'RE GOING TO
HAVE LOW TOW PASS YUM AND THEN
AFTER YOU GIVE IT IT WILL GO
HIGHER.
SOME ARE MORE COMPLEX FOR
HYPOMAGAZINIA, I WAS EXPECTING
THE SAME CURVE AND ALTHOUGH IT
IS NOISY, I GOT IT.
THAT IS BECAUSE LOW MAGNESIUM
CAUSES LOW POTASSIUM IN SUCH A
WAY YOU CAN'T REPLETE IT.
I DON'T !áYa TIME TODAY BUT I
COULD GO THROUGH IT.
WHAT YOU EXPECT IS LOW MAGNESIUM
BEFOREHAND ON AVERAGE FOR --
HYPOMAGNESIUM MEANS LOW
MAGNESIUM HERE FOR PATIENTS THAT
HAVE LOW POTASSIUM BEFORE
HAPPENED AND WHEN YOU REPEAT IT
THE POTASSIUM GETS REPLETED
ALSO.
INTERESTING PROBLEMS.
SO HERE, PANCREATITIS CAUSES
HYPOGLYCEMIA SO CAUSE AND
AFFECTiO")
ARE REVERSED.
I HAVE HYPOGRISEMIA FIRST THEN
PANCREATITIS.
WHY?
THIS IS NOT A DIAGNOSIS OF
PANCREATITIS.
THIS IS NOT A DISEASE.
PANCREATITIS OCCURRED OVER HERE
SOMEWHERE.
THIS IS WHERE WE MADE THE
DIAGNOSIS OF PANCREATITIS.
SO IF YOU GO IN AND TRY TO USE
HEALTH RECORD DATA TO DO THESE
ASSOCIATIONS STUDIES, YOU HAVE
TO KNOW WHAT YOU'RE DOING
BECAUSE YOU MIGHT ACCIDENTLY
FLIP CAUSE SPA AFFECT BECAUSE
YOU FORGET THAT THIS IS THE TIME
OF DIAGNOSIS NOT THE TIME WHEN
YOU GOT THE DISEASE WHICH WAS
OFF TO THE LEFT OVER THERE.
THE SPECIFICITY OF THE CONCEPT
HERE WE SEE TWO DIURETICS.
YOU SEE THIS SHAPE WITH TOO HARD
CREATININE.
IT MEANS YOU WERE FLUID OVER
LOADED SO YOU WERE HEART FAILURE
BEFOREHAND AND AFTER YOU GOT THE
DIURETIC, YOU BECAME MORE
CONCENTRATED AND YOUR BLOOD AND
YOUR CREATININE WENT UP.
WHAT IS 24 WORD?
DIURETICS.
THESE AREéG!i CONSISTENT.
THIS IS A DIFFERENT SHAPE.
WHY DID THAT HAPPEN?
IF YOU MENTION THIS IN THE NOTE
IT'S PROBABLYT3
GIVING IT.
YOU MENTION DIURETIC, YOU COULD
BE SAY ANYTHING.
SO THE:Ben SPECIFICITY OF THE
CONCEPT IS AFFECTING IN A BIG
WAY THE SHAPE OF THE CO
MY POINT BEING THAT YOU CAN'T
JUST THROW -- IT'S NOT A MATTER
OF THROWING DATA IN ONE END AND
GETTING AMAZING CONCLUSIONS OUT
THE OTHER SIDE.
FORMERLY AT STANFORD NOW
COLUMBIA DID A STUDY.
TWO DRUGS THAT ARE SO COMMON
THAT MILLIONS OF PATIENTS TAKE
BOTH OF THEM.
WHAT HE DISCOVERED BASED ON A
DATABASE WAS THAT EITHER DRUG BY
ITSELF DOESN'T CAUSE
HYPOGLYCEMIA WHICH COULD BE BAD
IN DIABETES PATIENTS BUT IF YOU
TAKE THE TWO TOGETHER, YOU GET
THIS BUMP.
SO HE FOUND THAT IN THE FDA
DATABASE.
I JUST THREW IT INTO THAT SAME
BLACK BOX RIGHT HERE.
JUST IN THATóR1y EQUATION AND
YOU
CAN SEE -- I DON'T KNOW EXACTLY
WHY THAT IS DECLINING.
I HAVE TO LOOK IN THAT FURTHER.
BUT YOU CAN SEE A BUMP HERE e]2
IS NOT PRESENT THERE.
IT SEEMS TO BE THE WAY WE HAVE
FILTERED THE THING, WE SEEM TO
BE GETTING REASONABLE RESULTS.
SO OVERALL, IF YOU CAN ONE WAY
TO LOOK AT WHAT THIS PROJECT IS,
THE TRUE PATIENT STATE GETS
RECORDED AND THAT CAUSES A --
DUE TO THE HEALTH CARE PROCESS.
I WANT TO COME UP WITH A
EXPLICIT MODEL FOR THE HEALTH
CARE PROCESS BUT I CAN THEN USE
IN THE ANALYSIS STAGE.
SO THAT IS THE GOAL TO
UNDERSTAND HEALTH PROCESSBErAND
USE IT.
HERE WE SEE -- I SAID LET ME TRY
LUMPING THINGS TOGETHER.fHÑpXhÑ
LET ME CORRELATE VARIABLES FROM
THE HEALTH RECORD WITH HEALTH
CARE PROCESS EVENTS.
ADMISSION, DISCHARGE, EMERGENCY
ROOM.
THIS IS INR AND PTT.
TWO COAGULATION TESTS.
YOU'LL NOTICE ON THE RIGHT-HAND
SIDE EVERY PAIR LOOKS ALMOST
IDENTICAL SO IT COULD FIGURE IT
OUT BASED ON COMPARING TO THE
HEALTH CARE PROCESS THEY SHOULD
BE CLUSTERED TOGETHER.
THEN I DID ANEMIA A NATURAL
LANGUAGE PROCESSING FROM THE
NOTES.
HEMOGLOBIN, A LAB TEST.
AT FIRST I SAID THEY DIDN'T
MATCH AT ALL.
AND THEN I REMEMBERED, AND AFTER
I SUBMITTED THE FIRST VERSION OF
THE PAPER UNFORTUNATELY, BUT NOT
AFTER THE LAST VERSION,
FORTUNATELY, HEMOGLOBIN WHEN IT
GOES LOW, THAT MEANS YOU HAVE
MORE ANEMIA.
THEY ARE IN($ @ OPPOSITE
DIRECTIONS
AND I BELIEVE FACT, IF YOU LOOK
AND FLIP EVERY OTHER ONE, THEY
ARE PERFECT MATCH.
SO THEN WHEN I DID THE
CLUSTERING, YOU SEE THE RED CELL
COUNT HEMOGLOBIN MAKES SENSE.
LIVER TESTS GO TOGETHER.
COAGULATION TESTS.
SO THIS THING IS FIGURING OUT
THAT THESE TESTS IN THEIR
REACTION TO HEALTH CARE PROCESS
MODEL ACT SIMILARLY.
HOW CAN THAT HELP ME?
WHEN I WANT TO USE A VARIABLE
YOU, IF I HAVE COME UP WITH AN
ALGORITHM FOR ONE, I CAN USE IT
AND MODIFY FOR ANOTHER ONE AND
REDUCE THAT SIX MONTH EFFORT.
MORE IMPORTANT, SO THIS IS A
STUDY I DID, A STATEN
CHOLESTEROL DRUG.
AS WE KNOW, STATENS CAN CAUSE
MUSCLE PAIN.
~y AND THAT
SO CAUSES MUSCLE DAMAGE
IS CAUSING YOUR CREATININE
KINASE TO GO UP.
WHAT THIS RED CURVE TELLS YOU IS
THAT AFTER YOU TAKE A
YOU'RE COUNTRY ATINE KINASE GOES
DOWN.
SO WHEN I DO AN EHR STUDY OF
STATENS, I WOULD CONCLUDE LIKE A
FEW WEEKS AGO IN JAMA THERE WERE
NO AFFECTS FROM DABBA GAT RIN.
A BILLION DOLLARS.
I SHOW THAT STATENS PROTECT YOUR
MUSCLES.
IF YOU WANT TO PROTECT YOUR
MUSCLES, TAKE A STATEN.
I KNOW THAT NOT TO BE TRUE.
I TOOK THAT HEALTH CARE PROCESS
MODEL AND STUCK IT IN THE SECOND
CURVE AND WHAT I DID IS I PUT IN
THE STATEN, TOTAL CK AND THE
INPATIENT ADMISSION.
PUT THEM IN SOMETHING CALLED A
GAUGER CAUSATIONMENT A LAGGED
REGRESSION EQUATION.
WHAT HAPPENS?
SHEAR WHERE YOU GET THE HIGH CK.
THIS IS WHERE YOU HAVE MUSCLE
DAMAGE.
IT IS POSITIVELY CORRELATED WITH
YOUR STATEN IF YOU LOOK BACK IN
TIME.
IN OTHER WORDS STATENS ARE IN
FACT CAUSING MUSCLE DAMAGE.
BUT IF YOU LOOK RIGHT AROUND
WHEN YOU ORDER THE STATEN, IT
SEEMS INVERSELY CORRELATED.
SO WHY IS THAT?
YOU'RE A DOCTOR.
YOU'RE GOING TO ORDER A CHRONIC
DRUG FOR A PATIENT.
YOU DON'T ORDER IT WHEN THEY ARE
ACUTELY ILL.
YOU ORDER WHEN THEY ARE
RELATIVELY HEALTHY.
SO PATIENTS WILL LOOK RELATIVELY
HEALTHY WHEN YOU FIRST ORDER
THAT DRUG.
IF WE LOOKKfC BACK IN TIME, IN
FACT, WE ARE SHOWING THAT STATEN
IS CORRELATED WITH MUSCLE DAMAGE
LATER ON.
WHY DID THIS THING HAPPEN IN THE
FIRST PLACE?
BECAUSE UP HERE WHAT WAS GOING
TO, WHEN DO WE LEARN THAT YOU'RE
TAKING YOURu=YF STATEN?
YOU'RE SEEING OUTSIDE DOCTOR
ACROSS THE CITY OR SOMETHING.
WE LEARNED IT WHEN YOU COME TO
THE EMERGENCY ROOM.
WHAT ELSE HAPPENS IN THE
EMERGENCY ROOM?
YOU COME IN WITH AN INJURY OR
SOMETHING OR A HEART ATTACK AND
WHAT HAPPENS DURING YOUR
HOSPITAL STAY?%'!Y
YOUR CK GOES DOWN OVER TIME.
SO, WHAT HAPPENS IS I THINK YOU
START A8;
HIGH C.
AND IT GOES DOWN AND I THINK
THAT WAS THE CAUSE OF THIS
MISTAKE OVER HERE.
SO, IT'S A FORM OF CONFOUNDING
AND THIS IS WHAT WE NEED TO BE
ABLE TO SOLVE AND IF WE WANT TO
USE EHR DATA.
WE STARTED LOOKING AT TIME AND
LET ME SHOW YOU.
ONE FUN STUDY SAYS WHEN A DOCTOR
IN THEIR NOTES SAYS 3 WEEKS AGO,
3 MONTHS AGO, WHAT DOES THAT
MEAN REALLY?
HOW CLOSE ARE THEY?
IF I'M GOING TO US TO THESE
DATA -- WHAT WE FOUND IN THIS
CURVE, I WON'T GO INTO TOO MUCH
DETAIL, WHEN THEY SAY THREE
DAYS, THREE WEEKS, THREE MONTHS
OR THREE YEARS AGO, THE ERRORS
ON THE STANDARD DEVIATION IS
LESS THAN .2.
SO IT SCALES WITH THE TIME.
HOWEVER, SO WEq.QóR BUILT A
REGRESSION EQUATION SO YOU COULD
CALCULATE HOW CLOSE THAT PERSON
IS SAYING HERE ISNí.
IF YOU SAY SOMETHING HAPPENED 19
YEARS AGO, IT'S PROBABLY 17
YEARS AGO.
IF YOU SAY SOMETHING HAPPENED 20
YEARS AGO?
20 YEARS IS TWO DECADES.
AND IN FACT, IT'S LIKE 10-30
YEARS NOT 20R
THIS SAID WHAT YOU LEARN BY
HAVING A LARGE ENOUGH DATABASE
AND KNOWING TO ASK THE RIGHT
QUESTION.
I TALKED ABOUT -- SHOWN THIS
DIAGRAM BEFORE.
WHAT I WANT TO SHOW RIGHT HERE,
IS AGAIN ON THIS SCALE, AS YOU
CAN SEE, THIS IS APPLICABILITY
AND YOU GO MORE TIME, THE
PREDICTABILITY DROPS BUT DOESN'T
DROP COMPLETELY.
IF I GO ON THIS AXIS, THE NUMBER
OF MEASUREMENTS IT DROPS TO
ZERO.
SO I SAID, WHAT IS GOING ON
THERE?
WHY IS THAT?
SO LET ME SHOW YOU THIS SET PAIR
OF GRAPHS.
IT MAKES SENSE SO THIS IS
LOOKING AT KIDNEY FUNCTION.
I'M TAKING TO KIDNEY FUNCTION
MEASUREMENTS.
IF THEY ARE AN HOUR ART PARKS
THEY ARE SIMILAR.
A YEAR, THEY
MIGHT
IF THEY ARE0'
HAVEiMí@Ñ CHANGED.
AND THAT IS WHAT WE SEE HERE
WHAT WE EXPECTED.
AS TIME GOES FROM ONE HOUR TO A
LITTLE LESS THAN A YEAR, THE
AMOUNT THAT THEY CAN VARY, THE
ABSOLUTE VALUE OF THEld
DIFFERENCE BETWEEN THE PAIR,
GOES UP OVER TIME.
SO THEN I MADE A SIMPLE CHANGE.
I SAID, LET ME ONLY LOOK AT
MEASUREMENTS THAT ARE
SEQUENTIAL.
SO, ON THIS ONE, I COULD HAVE
ANY NUMBER OF MEASUREMENTS IN
BETWEEN, THIS ONE, IS SEQUENTIAL
SO, IT COULD BE -- IT ALWAYS HAD
TO BE MAYBE SOMEONELq+çZáTáU)ED
THE
CREATININE A YEAR FROM NOW
ORXmi0÷ A
DAY FROM NOW AND THAT'S ALL I
GRAPHED.
WHAT YOU SEE HERE IS THERE IS NO
CHANGE IN THE VARIABILITY FROM
AN HOUR TO A YEAR.
SO WHAT IS ANYTHING ON THERE?
NOW THERE IS SOME VARIABLES THAT
ARE EXCEPTIONS LIKE HEART
EXPIRATE RESPIRATORY RATE WHERE
AS GET SICKER, THEY GET MORE
REGULAR.
MOST THINGS, THE MEDICINE GETS
MORE VARIABLE WHEN YOU GET
SICKER.
YOU'RE ANEMIA AND GLUCOSE LEVEL
AND LOTS OF THINGS DO THAT.
SO IN GENERAL, WHEN YOU
SICK, SO THIS IS WHERE THE
HEALTHY, YOU GET SICK, GET MORE
VARIABLE, AND AS YOU RECOVER,
YOU'RE BEING TREATED AND GET
BETTER.
MAYBE YOU DISAPPEAR BECAUSE YOU
GO TO THE HOSPITAL AND SEE WHAT
HAPPENS.
SO, THAT'S A PROBLEM WHEN WE ARE
DOING THESE ANALYSIS BECAUSE
THESE+RQhá
TO BE STATIONARY BECAUSE WE
DON'T WANT PATIENTS TO BE
STATIONARY.
IF THEY COME IN SICK, WE WANT TO
MAKE THEMw8,é BETTER.
BUT IF YOU SEE WHAT DO DOCTORS
DO?
THEY DON'T SAMPLE YOU VERY
OFTEN2>@L
UNTIL YOU'RE SICK AND THEN THEY
START TO SAMPLE TAKING YOUR
BLOOD TESTS VERY OFTEN AND
THENqU$EY SLOW
DOWN AGAIN AS YOU GET
BETTER.
THE HOPE IS THAT THOSE TWO
k
THINGS CAN CORRECT THEMSELVES.
EACH OTHER RATHER.
AND YOU CAN
OVER TIME WE DID THIS EXPERIMENT
WHERE WE COMPARED, LET'S
PRETEND, FORGET ABOUT TIME.
LET'S PRETEND THAT TIME IS NOW
SIMPLY THE SEQUENCE ZTT
EVENTSY!
THE CLOCK, I'M GOING TOé'9
IT'S THE FIRST MEASUREMENT, THE
SECOND MEASUREMENT AND THE THIRD
MEASUREMENT.
THAT'S MY SCALE OF TIME NOW.
THEN THAT'S SEQUENCE TIME AND
CLOCKrúhty TIME IS TIME ON
THEX1N CLOCK
-
AND WARP TIME IS SOMETHING THAT
z$ñ A MEASURE OF YOUR
AND THIS
VARIABILITY ANDURE CAN SEE THAT0
IT GOES DOWN AS YOU GO FROM
CLOCK TIME TO,nTIME.
HOW DOES IS NîMç HELP ME?
THIS IS PREDICTING GLUCOSE LIKE
THAT PREVIOUS CURVE.
THIS IS A PATIENT'S RECORD.
I'M TRYING TO PREDICT FUTURE
GLUCOSE VALUES.
AND WE ARE REALLY USING THIS IN
REAL LIFE BECAUSE WE ARE TRYING
TO TELL TYPE TWO TYPE TWO DIE
BEATIC
PATIENTS SHOULD THEY INCREASE
STARCH, LOWER SUGAR.
EAT AT A DIFFERENT TIME?
I'M TRYING TO PREDICT GLUCOSE.
LIKE I HAVE A BUNCH HERE, A
BUNCH HERE.
I DON'T WANT KNOW WHAT THESE
BUMPS MEAN.
THEY DON'T SEEM TO MEAN VERY
MUCH.
IF I USES SEQUENCE TIME, NOW I
SPREAD THE THINGS OUT SO THAT IT
IS JUST A OPPORTUNITY BETWEEN
EVERY POINT.
YOU CAN SEE A PATTERN HERE THAT
MAKES SENSE.
ú
AND MY PREDICTABILITY
THAT IS GOOD FOR MY EQUATIONS
AND COMPUTATIONALLY IT'S MUCH
SIMPLER BECAUSE NOW/ ú"Ñ I HAVE
INTEGERS INSTEAD OF REAL NUMBERS
AND HIPPA.
TO SHARE
I'M NOT ALLOWED;
DATABASES WITHCaz DATES,
ACCORDING
TO SAFE HARBOR.
BUTI:D
IF I'M JUST SHARING SEQUENCE OF
MAY BE ABLE
z SHARE
EVENTS, IJ7ylX:)÷
DATABASES AS WE TALKED
ABOUTe@!Gf
EARLIER TODbR
CAN'T SHARE IF I NEED TO SHARE
DATES.@P'D THEN,)V;q[.3
áARTING TO BElS
CAN USE OR I'MIQ+Wpñç,
HEALTH RECORD TOA-k[k STUDYJy
PHYSIOLOGY.
4HIS IS IN THE MEDICAL"G#
OVER
BUT WHAT I'M THINKINGDâ!z OF
IS<v
THE WHOLE CITY.
-FxCAN START SENDING
PHYSIOLOGYvQ:.DTJU
GEOGRAPHICALLY.
IN THIS CASE, IT WAS IN2
THEá?cYt ICU
[
WHERE THEY DON'
WE ARE THINKING WHERE THERE IS A
LOT OF FAST-FOOD AND MORE
HEALTHY FOOD AND INCOME LEVELS
AND SEE HOW PHYSIOLOGY CHANGES
ACROSS THE CITY.
JUST TO MAKE A POINT THAT A LOT
OF THIS STUFF, SO I DIDN'T SHOW
YOU MUCH MATH TODAY BUT THESE
THREE PAPERS IS ONE LONG MATHS
EQUATION.
BUT THESE, THE TOP TWO JOURNAL
IN NONLINEAR ANALYSIS AND
PHYSICS ARE PRE, PLA AND CHAOS.
WE HAVE PUBLISHED IN TWOrL
THOSE THREE TOP JOURNALS8óxÑZ6S8
PHYSICS.
SO IN FACT, WHEN WE SENT OUR
FIRST PAPER, PLA, THE REVIEW,
DIDN'T EXPECT IT TO BE TAKEN AT
ALL BECAUSE THEY DON'T USUALLY
PUBLISH MEDICINE BUT THEY
THOUGHT IT WAS GENERALIZES AGE
AND THEJÑi]÷ REVIEWER WAS NICE
AND
SENT BACK A PAPER FROM
CHEMISTRY.
BIOLOGY OR
NOTHING TO DO WITH4+
MEDICINE, THAT WASré
SOLVING THE SAME PROBLEM AS WE
WERE AND LUCKILY WE HAD GO ONE
STEP FURTHER SO WE GOT TO GET
INTO THE JOURNAL.
BUT IT SHOWS THAT WE REALLY NEED
TO BREAKDOWNAq
WITHIN NIH BUT OUTSIDE OF
NIH.9A?u
AND LD
WHAT I HAVE D
ONE IT IS
SO
INFORMATICS TALK RATHER THAN
CLINICAL.
BUT THE PURPOSE TO ADVANCE
CLINICAL MEDICINE.
SO THERE
THAT EVOLVED INTO THE
OBSERVATIONAL HEALTH DATA
SCIENCES AND INFORMATICS
INITIATIVE.
THIS IS AN INTERNATIONAL
COLLABORATION, ABOUT 92 MEMBERS
NOW.
TO>iú+ DO OBSERVATIONAL
RESEARCH
AROUND THE WORLD.
THE GOAL IS TO COLLECT A BILLION
PATIENT RECORDS OVER THE NEXT 10
YEARS BUT WE DID A TALLY OF
WHERE WE ARE AS OF OCTOBER 16,
AND 52 DATABASES WERE USING OUR
FORMAT BY THEN WITH 682 MILLION
PATIENT RECORDS.
NOW I HAVE TO TELL THAT YOU
INCLUDES DUPLICATES BECAUSE IF A
PAYOR AND A HEALTH SYSTEM DID
IT, THOSE OVERLAP.
SO THERE ARE DUPLICATES.
AND IN SOME CASES TWO PEOPLE
BOUGHT THE SAME DATABASE AND
REDID IT.
AND SOME OF THESE PEOPLING ARE
NOT OUR COLLABORATORS SO I CAN'T
GO ASK THEM QUESTIONS.
ALL OUR STUFF IS AVAILAB FOR
FREE ON THE INTERNET.
SO YOU CAN USE OUR STUFF.
BUT WHAT IT TELLS YOU IS, THAT
IS ONE TENTH OF THE WORLD
POPULATION.
ENCODING ALL THE HEALTH RECORDS
IN ONE OF THESE DATA BASES IS
FEASIBLE.
IF YOU CAN DO A TENTH OF THE
WORLD POPULATION, YOU CAN DO THE
WHOLE THING.
THAT IS IMPORTANT.
THIS IS USING THE DEEP
INFORMATION MODEL WHICH MEANS
IT'S NOT JUST A DUMP OF YOUR
DATA.
IT IS A DETAILED, EVERY SINGLE
CODE WE TELL YOU IF IT'S A HEART
ATTACK, WE ARE VERY SPECIFIC.
YOU HAVE TO WORK WITH THE
BASED LARGELY ON THE NLS.
IT'S A LOT OF WORK TO GET INTO
THIS FORMAT YET PEOPLE HAVE
MANAGEDDED:];Y÷ TO GET 680
MILLION
PATIENTS INTO IT.
WE USE IT FOR DISCOVERING DRUG
SIDE EFFECTS AND NEW USES FOR
DANGEROUS.
THE PEOPLE WHO DO THE BASIC
INFRASTRUCTURE AND TERMINOLOGY,
STATISTICAL METHODS, ALSO ARE
TIGHTLY COUPLED TO THE PEOPLE
DOING THE CLINICAL STUDIES.
SO THE WHOLE THING, WE ONLY
BUILD INFRASTRUCTURE THAT IS
USEFUL YOU KEEP YOUR DATA
LOCALLY BEHIND THE FIREWALL.
WE SEND YOU THE QUESTION, AND
YOU SEND IT BACK AND THEN WE
ASSEMBLE THE ANSWER.
WHAT WE ARE DOING IS, A FIRST
TEST CASE AND THEN PUTTING OUT
AN RFA TO THE WORLD SAYING,
THERE ARE ANY STUDIES YOU'RE
WOULD LIKE TO DO ON 200 MILLION
PATIENTS FROM AROUND THE WORLD?
WE ARE DOING IT OURSELVES FIRST.
WE FIGURE THERE WOULD BE TWO
TRACTS.
THE RESEARCH TRACK WHERE OUR
RESEARCHERS CAN ASK FROM AROUND
THE WORLD AND SECOND IS THE HIGH
SCHOOL TRACK WHERE WE HAVE HIGH
SCHOOL STUDENTS TO HAVE ACCESS
TO THIS DATABASE AND WE WOULD
HELP THEM AND SEE WHAT THEY COME
UP WITH AND SEE IF THEY COME UP
WITH BETTER QUERIES THAT THE
RESEARCHERS.
THE SUPT MEANT TO MY R OWE 1 IS
DOING SOME WORK.
-- RO1.
THIS IS SOUTH KOREA, A CITY IN
SOUTH KOREA, 2.3 MILLION
PATIENTS ON THE INTERNET.
YOU CAN GO ON THE INTERNET TODAY
AND GO TO THIS WEBSITE AND LOOK
FOR THE ACHILLES TOOL AND FIND
THE SAMPLE DATABASE.
THAT IS A CITY IN A LARGE
MEDICAL CENTER IN SOUTH KOREA.
YOU CAN BROWSE EVERY DIAGNOSIS
THEY EVER HAD, EVERY VISIT THAT
HAVE EVER DONE.
IT'S HARDER IN THE U.S. TO GET
PEOPLE -- NO PATIENT DATA.
TO THE IS ABSTRACTED SO IT IStPA
SAFE.
WE ARE PUSHING TOWARDS PEOPLE
SAYING HERE IS MY DISEASE, MY
GENDER ANDl
OCCUR AROUND THE WORLD?
SO, IN CONCLUSION, HEALTH RECORD
DITA HAS VALUE FOR CLINICAL
RESEARCH.
I THINK THEREXñGW NEEDS TO BE
MORE
FORMAL STUDY OF HEALTH RECORDS.
I THINK THERE NEEDS TO BE A
TIGHT INTEGRATION OF THE
CLINICAL GOALS AND THE
METHODOLOGIC RESEARCH.
AND YOU NEED TO PULL INv2b&
EXPERTISE FROM MANY DISCIPLINES.
I DON'T USUALLY -- THIS LAST ONE
I DON'T USUALLY PUT THINGS LIKE
THIS ON A SLIDE BUT I FIGURE IF
NOT NOW, WHEN?
NLM'S RO1 CREATED A FIELD AND
WHAT MADE ME THINK OF PUTTING
THIS ON IS BECAUSE VALERIE AND I
WERE AT A PRECONFERENCE TO OUR
ANNUAL MEETING ON PHENOTYPING
AND ONE OF THE ORGANIZERS
POINTED OUT THAT BASICALLY THIS
WORK HAD LED LIKE THE GROUP GREW
OUT AS SONS AND CHILDREN AND
GRANDCHILDREN OF THIS WORK.
SO NLM HAD A BIG IMPACT ON THE
FIELD.
AND THEN JUST TO POINT OUT THE
TEAM AND AGAIN POINT OUT THE
FUNDING.
THANK YOU.
[ APPLAUSE[%3Nyf
>> I HAVE A QUESTION.
I DIDN'T UNDERSTAND SO A POINT
OFakydz CLARIFICATION.
>> SO THE P VALUE IS IN FINITES
MALL.
>> MY ARGUMENT THOSE ARE REAL IS
THE SHAPE OF THE KURSK.
YOU'LL NOTICE THAT FOR SIMILAR
THINGS, I GOT IDENTICAL SHAPED
CURVES FOR EVERY SINGLE ONE.
THAT WOULDN'T HAPPEN BY
ACCIDENT.
AND IN FACT, I MEAN WHAT IS
HAPPENING THERE IS THAT I'M
THROWING IN 3 MILLION --
PATIENTS SO HOW MANY OF THOSE
HAVE THE ACTUAL AFFECT?
SO IT IS SHOWING UP AS A SMALL
OR SQUARE IN AFFECT.
IT'S AVERAGING OUT SUFFICIENTLY.
PARTIALLY BECAUSE I NORMALIZE
BYuNF&÷
TAKING THE TECHNIQUES.
>> I WAS THINKING IN TERM OF
INDIVIDUAL PROVISION.
IT MUST HAVE THE POOR ACCURACY.
>> THAT ONE I'M USING TO -- THE
CORRELATION CURVES ARE BEING
USED TO LEARN ABOUT HEALTH CARE.
SO I'M TRYING TO UNDERSTAND THE
PROCESS.
FOR PREDICTION, IT DEPENDS ON
WHAT WE ARE TRYING TO DO.
FOR PREDICTING READMISSION, IT'S
.81 BUT IT'S NOT.6 AT LEAST.
SO THAT IS ABOUT WHERE WE ARE
FOR MOST OF OUR PREDICTION.
FOR TRIVIAL5©z PROB
WITH METHODS THAT YOU ARE
>> I THINK THAT WILL DO IT.
WHAT WE ARE TRYING TO DO NOW, I
MEAN THEY ARE DOING BETTER AND
BETTER AT
USING THAT AS AN EXAMPLE ON
PURPOSE.
THE REASON THAT WORKS PRETTY
WELL -- AND THE OFFICIAL
PANCREAS.
IT'S GETTING SO GOOD AND
MATCHING PHYSIOLOGY.
THE BENEFIT YOU HAVE THERE IS
CONSTANT MONITORING.
YOU HAVE A CLOSED
MY HOPE IS WE DOCK THAT KIND OF
WORK ON LARGER SCALE THINGS THAT
ARE NOT -- SO TO USE OUR
EXAMPLE, TYPE II DIABETES WHERE
SOMEONE IS NOT BEING MONORD
CONSTANTLY ALTHOUGH IT MIGHT
INVOLVE GLUCOSE MONITORING, AND
MAKE RECOMMENDATIONS ON THE
CONTENT OF THE MEAL FOR THAT
MORNING.
I THINK WE WILL BE ABLE TO DO
MODELING AND PREDICTION MUCH
BETTER.
CHESS.
IT'S LIKE SOL63#U
IT'S HARD TO SOLVE CHESS UNTIL
WE DID IT AND THEN WE SAID, THAT
WAS AN EASY PROBLEM TO DO IT FOR
OUR COMPUTERS BECAUSE WE BROKE
IT DOWN INTO PARTS.
I THINK WE WILL BE ABLE TO DO
SOME BETTER PREDICTION ALSO.
BUT SO I HAVE BEEN IN THE FIELD
FOR SINCE 88.
SO IN 25 YEARS, I DON'T THINK WE
HAVE GONE AS FAST AS I WOULD
HAVE HOPED.
>> [ OFF MIC ]
>> YOU CAN ONLY - EYE BELIEVE WE
WILL.
EVEN WITH 7 BILLION PATIENTS
RECORDS THERE A LIMIT OF WHAT
YOU CAN DO THERE AND THEREFORE
YOU HAVE TO GET BETTER AT
PHYSIOLOGY.
I THINK TO GO TO THE NEXT BIG
LEAP AFTER -- THERE IS AN
INITIAL LEAP WE CAN MIKE HERE
AND THE NEXT WILL REQUIRE US TO
Sñ
UNDERSTAND BIOLOGY ANDA
PHYSIOLOGY BETTER AND COMBINE
THAT WITH THE EMPIRICAL DATA.
SO WE CAN'T DO IT ALL LIKE THIS.
>> I TAKE IT -- PERSONALIZED
MEDICINE IS MOSTLY FANTASY?
>> I THINK THAT DEPENDS ON WHAT
YOU MEAN BY PERSONALIZED
MEDICINE.
THE WARFRIN TREATMENT -- WELL,
200 MILLION DOLLARS IS NOT A LOT
OF MONEY TO DO PERSONALIZED
MEDICINE.
IF YOU LOOK AT NOT MY WORK BUT
WORK BY ANOTHER IN OUR GROUP FOR
CANCER CARE, THEY ARE ACTUALLY
DOING A SET OF PROJECTS WHERE
EACH PERSON, EACH CANCER PATIENT
IS AN RO1 AND THEY DO AN RO1
AMOUNT OF WORK ON THAT CANCER
IS MANYS TUMOR+Iú!
TUMORS IF YOU LOOK AT THEM.
AND FIGURE OUT WHAT ARE THE
BOTTLENECKS IN THAT
PERSON'SpÑUQ÷
TUMOR AND THEN WHAT
COMBINATION -- USUALLY NOT ONE
DRUG.
A COMBINATION WILL HELP THAT.
THAT IS TRUE PERSONALIZED
MEDICINE.
AND IN 10 YEARS, THAT COULD WORK
ON A SCALE THAT DOESN'T COST 3
MILLION DOLLARS PER PATIENT.
z÷
SO I DO HAVE HOPE FOR IT IS
THE)l!yd8
ANSWER.
>> [ OFF MIC ]
AND I THINK1Zim÷ ANOTHER THING,
POWER
AND AFFECT AND INFORMATICS AND
MEDICAL INFORMATICS AND MEDICAL
RECORDS STUFF AND WHERE IT ALL
GOES.
--
>> [ INAUDIBLE ]
>> SO WHAT ABOUT YOUR WORK ON
BIG6tG
[ LAUGHS ]
BIGGER DATA?
7 BILLION IS NOT BIG ENOUGH?
[ LAUGHS ]
LET ME POINT OUT THAT ACTUALLY
JUST PART OF THE INITIATIVE WE
HAVE TWO GRANTS.
ONE IS TRAINING GRANTS SO I
WON'T TALK ABOUT THAT.
THE OTHER IS A SUPPLEMENT TO OUR
RO1 AND THAT IS TO CREATE A
INDEX.
REMEMBER I SHOWEDnrC) YOU SOUTH
KOREA THAT YOU COULD GO AND
RIGHT NOW GO ON AND BROWSE THE
SOUTH KOREAN DATABASE?
THAT IS PART5u
SO YOU'RE A RESEARCHER AND YOU
WANT TO ASK A QUESTION AND YOU
NEED TO BE TO CHARACTERIZE THE
DATABASE.
SO THE DATA DISCOVERY INDEX WAS
PART OF THAT PROJECT.
HOW SHOULD YOU CHARACTERIZE A
CLINICAL DATABASE?
HOW DO YOU ADVERTISE IT SO
CLINICAL RESEARCHERS CAN FIND
IT?
AND THEN IT'S PROBABLY NOT GOOD
ENOUGH TO JUST SAY IT HAS THIS
MANY PATIENTS AND HAS THIS
ACCURACY.
YOU WANT THEM TO BE ABLE TO
TOUCH AND FEEL IT.
THAT IS ACHILLES.
THAT THING I SHOWED YOU IS OUR
ANSWER TO THE DATA DISCOVERY
INDEX TO HAVE A FEEL TO THE
CLINICAL RESEARCHER TO GO ON THE
INTERNET AND BROWSE THE THING
AND NICK AND I WERE SITTING
THERE THE OTHER DAY, WE THOUGHT
OF A STUDY, I TURNED AROUND TO
OUR VERSION OF THAT, BECAUSE WE
HAVE COLUMBIA A'S DATABASE
ALTHOUGH IT'S NOT ALLOWED ON THE
INTERNET YET.
WORKING ON THAT.
AND THE REASON IT'S NOT ON THE
Kxv>óÑr5v7fá%a
INTERNET IS/
KNIFE THROUGH THE PERSON'S HEART
ACCIDENTLY WHILE I WAS DOING A
VALVE OPERATION.
SO, THE INSTITUTIONS -- IT'S NOT
PATIENT
IT'S INSTITUTIONAL SENSITIVITY
TO THIS.
I
STAINTANEOUSLY WE KNEW HOW MANY
PATIENTS WERE ON DRUGS, AND IN A
COUPLE OF SECONDS, I COULD
ANSWER, COULD WE ANSWER THIS
QUESTION IN OUR DATABASE?
THIS WOULD NORMALLY TAKE A WEEK
TO MAKE A QUEER TOW AN ANALYST
OR SOMETHING.
SO THE SUPPLEMENT IF THE RO1 IS
WORKING ON TOOLS SO,41;
RESEARCHERS
CAN FIND DATABASES THEY WANT TO
THE DO WORK ON AND THEN SUBMIT A
QUERY AND I CAN RUN IT@ç7X
WITHOUT
THEM EVER HAVING TO TOUCH MY
DATA.
SO THAT IS WHAT WE ARE WORKING
ON.
THAT'S OUR PART OF THE BIG DATA.
>> THAT'S FASCINATING.
THANK YOU VERY MUCH.
[ APPLAUSE ]
>> SO NEXT VALERIE IS GOING TO
GIVE THE EXTRAMURAL PROGRAM
REPORT.
>> I LOVE FOLLOWING GOOD SCIENCE
WITH BUREAUCRACY.
THAT'S WHERE WE ARE HEADED.
BECAUSE ONCE A YEAR, THERE IS
SOME BUSINESS THAT WE HAVE TO
ATTEND TO AND SO I HAVE A COUPLE
OF THINGS THAT WE JUST HAVE TO
DO.
ONE OF THEM IS YOUR AS:÷x YOU
FOR YOUR APPROVAL OF OUR
OPERATING PROCEDURES.
AS YOU KNOW, THERE IS A DOCUMENT
IN YOUR BOOK ABOUT THIS.
WE ASK YOU EVERY YEAR, WE TELL
YOU WHAT WE DO.
WHATç-kal KINDS OF GRANT
ADJUSTMENTS
WE MAKE AT THE TIME WHEN AWARDS
ARE MADE AND WE REPORT BACK TO
YOU ANY ADJUSTMENTS WE MAKE THAT
WOULD BE AN INCREASE.
THAT MAKES ME LAUGH.
AN INCREASE TO WHAT REVIEW
APPROVED OF MORE THAN 40,000
DOLLARS.
WE'LL TELL YOU IF THAT
HAPPENS.e0p
AND THEN THERE ARE DOWN
REVISIONS OF BUDGET AND TIME
BOTH IN THE LENGTH OF AN AWARD
AND AMOUNT OF THE AWARD.
SOMETIMES THE REVIEWERS ASK FOR
THIS AND SOMETIMES OUR OWN STAFF
USE SCIENTIFIC JUDGMENT AND
RECOMMEND IT.
AND THERE ARE -- UPWARD
REVISIONS OF BUDGETS LIKE I
SAID, SOMETIMES THINGS HAPPEN AT
THE INSTITUTION.
THERE IS A CHANGE IN THE BENEFIT
RAID OR SOMETHING THAT WILL
REQUIRE AN UPWARD ADJUSTMENT.
SO, IT'S NOT JUST US FLINGING
MOON MONEY OUT HAPPILY ALTHOUGH
OF COURSE WE WOULD LOVE TO DO
THAT.
SPECIAL COUNCIL REVIEW.
THIS IS ANOTHER PART OF WHAT WE
ASK YOU TO APPROVE AND AS YOU
KNOW, THE ADDITIONAL
CONSIDERATION IS GIVEN TO ANY
NEW OR RENEWAL APPLICATION UNDER
CONSIDERATION FOR AN AWARD EACH
CYCLE.
TO ANY PI WHO HAS A MILLION
DOLLARS OR MORE IN DIRECT COSTS
GRANTS ALREADY FROM NIH.
SO AT EVERY MEETING BEFORE YOU
MEET, WE CHECK THE FILES TO SEE
IF NLM HAS ANYBODY IN THAT POOL.
AND IF WE DID, THEN WE WOULD
BRING YOU A RECOMMENDATION ABOUT
WHETHER WE SHOULD GO AHEAD AND
FUND IT, YOU COULD SAY YES OR
NO.
THE EP SUBCOMMITTEE DOES THIS
DISCUSSION AND THEN WE WOULD
BRING IT BACK TO YOU IN THAT
REPORT.
SO, THE EXISTING PROCEDURE,
WHICH I JUST SUMMARIZED FOR YOU
IS IN YOUR BOOK AT TAB 7A.\!R#
YOU FEEL LI
KE READING IT, YOU1> Y
NEED NOT.
BUT YOU MAY.
THESE PROCEDURES WERE AMENDED TO
IN CORN 8 THAT SPECIAL COUNCIL
REVIEW BACK IN 2012 AND THEN YOU
REAFFIRMED THEM EVERY FEBRUARY
AND IT IS FEBRUARY AGAIN.
SO I'M ASKING YOU FOR A VOTE OF
APPROVAL TO CONTINUE USING THESE
PROCEDURES THAT WE DESCRIBED
HERE.
>> [ OFF MIC ]
[ VOTING ]
>> THANK YOU.
NUMBER 2 IN OUR BUSINESS HERE.
EVERY OTHER YEAR, I PROVIDE YOU
WITH AN INCLUSION REPORT WHICH
IS REQUIRED BY NIH AND IN THIS,
I'M TELLING YOU ABOUT WHAT WE DO
IN INTERIM TO MAKE SURE THAT THE
GRANTS THAT WE AWARD ARE MEETING
THE NIH CRITERIA FOR INCLUSION
IN STUDY POPULATIONS THAT THE
COMPOSITION INCLUDES -- THAT
THEY HAVE ADDRESSED THE
INCLUSION BY GENDER AND RACIAL
ETHNIC GROUPS AND GIVEN A
RATIONAL IF THERE IS SOME SELECT
ACTIVITY.
SO AS YOU KNOW, NIH TRACKS HUMAN
SUBJECTS IN INVOLVEMENT AND
INCLUSION ACROSS ALL OF THE
INSTITUTES AND SO ALL OF US
CONTRIBUTE TO THIS REPORT.
THEY ASK EACH COUNCIL TO PREPARE
AND APPROVE A REPORT EVERY YEAR.
SO I PRESENT YOU THE DRAFT
REPORT, WHICH YOU HAVE AND I'M
GOING TO SUMMARIZE FOR AND YOU
THEN ONCE YOU GIVEN US THE OKAY,
THEN DR. LINDBERG SIGNS IT AND
TWO YEARS LATER I'LL BE BACK AND
DO THIS AGAIN.
SO HERE IS OUR INCLUSION REPORT
FOR 2013 AND 2014.
THE BIANNUAL REPORT.
I'M TELLING YOU WE FOLLOW ALL
THE NIH REGULATIONS REGARDING
INCLUSION.
SO OUR REVIEW PANELS, DISCUSS
HUMAN SUBJECTS, OUR PROGRAM
STAFF ARE ALWAYS THERE LISTENING
TO THE DISCUSSION AS WELL.
AND HUMAN SUBJECTS INCLUSION
FACTORS INTO SCORING UNLIKE
OTHER THINGS TALKING ABOUT
EARLIER LIKE THE DATA MANAGEMENT
PLAN.
THIS DOES AFFECT THE SCORE.
ALL OF OUR STAFF BOTH PROGRAM
STAFF AND THE REVIEW STAFF
ATTEND TRAINING THAT NIH
PROVIDES US ON INCLUSION SO WE
KNOW THAT WE ARE FOLLOWING AND
UP-TO-DATE.
NOW IF WE FIND DEFICITS IN AN
APPLICATION THAT WE ARE HOPING
TO AWARD, WHAT HAPPENS IS OUR
PROGRAM OFFICERS CONTACT THE
PRINCIPAL INVESTIGATOR AND ASK
HOW THEY ARE GOING TO BE
REMEDIATED.
OR IF THEY CAN FOR RATIONAL IF
THEY CAN'T.
AND WE WILL NOT AWARD AN AWARD
IF IT'S THE END OF THE FISCAL
YEAR, AND WE CAN AWARD BUT BAR
EXPENDITURE UNTIL THIS IS
SOLVED.
SO WE WON'T EVERY MAKE AN AWARD
UNTIL WE WE RESOLVE THESE
ISSUINGS.
IN THE TWO YEARS I'M REPORTING
ON, WE DIDN'T HAVE ANY
DISCREPANCIES TO REPORT.
BUT YOU MAY WONDER IF WE HAD
ANY.
WE DON'T DO CLINICAL TRIALS IN
THE TRADITIONAL SENSE BUT WE DO
RESEARCH THAT INVOLVES HUMAN
SUBJECTS.
SO, IN 2013, WE HAD FOUR
RESEARCH PROJECTS THAT HAD
ENROLLMENT OF ABOUT 1600
SUBJECTS.
HERE ARE THE NAMES OF THE FOUR
JUST FOR YOURY
THESE FOUR PJSvA(Uáy
IN 2014, TWO OF THEM FINISHED
AND TWO MORE ARE CONTINUING ON.
SO IN 2014, WE HAD TWO PROJECTS
THAT HAD RESEARCH PROTOCOLS
INVOLVING ABOUT ALMOST 900
PROJECTS, TWO OF THEM WERE FROM
THE SAME YEAR.
IN TABLES 1 AND 2 OF THE HANDOUT
WE STUCK IN YOUR FOLDER, YOU CAN
SEE AGGREGATE ENROLLMENT DATA
THAT ACTUALLY LAYS OUT WHAT THE
GENDER AND ETHNIC RACIAL BALANCE
ARE IN THESE8e . STUDIES.
SO, THAT IS OUR REPORT.
WE STUDY, WE WATCH OVER AND
DON'T MAKE AWARDS UNTIL WE KNOW
THEk=5pjUáRJz IF THERE WERE
PROBLEMS THAT THEY AREi
AND THAT IS THE SITUATION.
THOSE TWO ARE TWO CURRENT, THE
2014S.
I'LL BE BACK IN TWO YEARS WITH
ANOTHER REPORT.
SO I'M ASKING FOR YOUR APPROVAL
OF OUR APPROACH TO COMPLIANCE.
AND THE DRAFT REPORT THAT I GAVE
YOU.
OR QUESTIONS IF HAVE YOU
THEM.JBqFñ
[ VOTING ]
>> TOPIC 3.
NOW I'M GETTING INTO THE FUÄ
PART, I THINK.
I WANT TO TALK ABOUT -- SO THIS
TIME, OFTEN I'M TELLING YOU
ABOUT THE WONDERFUL SUCCESSES OF
OUR87
TO TALK ABOUT POSSIBILITIES FOR
Z GRANTS THAT WE
NEW KINDS OF;
DON'T CURRENTLY OFFER.
YOUPÅr PROBABLY REMEMBER, OF
COURSE
YOU DO, THAT AT OUR LAST BOARD
MEETING, TRUDY REPORTED BACK
FROM THE EP SUBCOMMITTEE WE HAD
A DISCUSSION IN THE COMMITTEE
ABOUT PERSON ORIENTED GRANTS AS
OPPOSED TO PROJECT ORIENTED
GRANTS BECAUSE THIS IS A TOPIC
AT NIH.
AND SO, I WANTED TO BRING IT
BACK AND DISCUSS IT WITH THE
FULL BOARD.
SO, A YEAR OR SO AGO WHEN
THE!úxvx IC
DIRECTORS
RANGE PLANNING,Oõ÷ EVERYBODY --
THIS IDEA CAME UP THAT MAYBE --
THIS IDEA IS ALWAYS HERE AT NIH.
HOW CAN WE FOSTER MORE
INNOVATION?
PEOPLE SAY RESEARCH GRANTS ARE
eNCREMENTAL AND WE WANT THIS --
AND ET CETERA.
AND THERE IS THE SENSE THAT
PEOPLE SPEND TOO MUCH TIME
WRITING GRANT APPLICATIONS AND
WOULDN'T IT BE GREAT IF WE COULD
FIND A WAY TO MAKE IT EASIER FOR
THEM?
SO, THERE WAS DISCUSSION ACROSS
ALL THE ICs IN THINKING ABOUT
IMPLEMENTING GRANT PROGRAMS THAT
COULD SUPPORT A PERSON'S
RESEARCH PROGRAM SO NOT TIED SO
MUCH TO A PROJECT AND SPECIFIC
AIMS.
AND SO, THE GENERAL CONCEPT WAS,
GIVE MORE THAN 5 YEARS, GIVE A
LOT MORE MONEY THAN GIVEN NOW.
THAT WAS THE GENERAL FRAMEWORK
THAT WAS PRESENTED TO ALL OF THE
INSTITUTES AND SO WE COULD SAY
YES, WHAT DO YOU WANT TO DO?
NO PROJECT PLANNERñÑvC OR
SPECIFIC
AIMS OF THE KIND WE ARE USED TO
BUT A FOCUS ONR$cU THE
INVESTIGATORS
T)OPOSED PROGRAM OF RESEARCH
PAST ACCOMPLISHMENTS AND ALSOr
WHICH MIGHT BE A MORE GENERAL
STATEMENT LIKE AN ESSAY.
AND THEN A SPECIAL KIND OF
REVIEW WOULD BE USED PROBABLY
NOT THE THAT ADDITIONAL PEER
REVIEW.
SO, YOU PROBABLY NOTICED TWO
INSTITUTES HAVE ALREADY ISSUED
ANNOUNCEMENTS FOR AWARDS THAT
ARE SIMILAR TO THIS KIND OF --
RESEARCH EXCELLENCE, RIGHT?
THAT SOMEBODY HEADS BEEN HIGHLY
SUCCESSFUL HAS HAD A COUPLE OF
RENEWALS AND HAS A[0PI J
HIGH SCORING ONCE AND IT'S BEEN
FUNDED BY AN INSTITUTE FOR A
PERIOD OF TIME.
COULD APPLY FOR ONE OF THESE
RESEARCH EXCELLENCE AWARDS.
SO THESE ARE TWO EXAMPLES.
NCI HAS ONE.
NATIONAL INSTITUTE OF GENERAL
MEDICAL SCIENCES HASB2K#v ONE.
THEIR PARAMETERS AREN'T THE SAME
BUT GENERALLY THEY ARE LONGER
AND GIVE MORE MONEY.
I HEARD SOMEONE FROM NCI SAY
THEY EXPECT TO FUND ABOUT 50 OF
THESE A YEAR.
SO, THAT'S A LOT OF MONEYóíh"
INVESTED IN THESE RESEARCH
EXCELLENCE AWARDS WHERE THEY ARE
JUST SAYING, YOU HAVE BEEN A
GREAT RESEARCHER SO FAR.
WE TRUST YOU.
YOU TELL US GET A GOOD REVIEW.
AND IN THE CASE OF NIGMS, I
BELIEVE THAT THE DIRECTOR
HAS%Vo"
HAVE OR TO AWARD JUST8W:íp THIS
KIND
OF9;(
:z EVERYBODY HAVE ONE GRAN
T
LETL
FROM NI GO.
MS, ONE RESEARCH GRANT AND THAT
IS IT.
RIGHT.
NO TWO AT ONCE.
SO, AND, DWIGHT, OUR GRANTS
MANAGEMENT OFFICER, TOLD ME THAT
IN HIS LIFETIME, AT NIH THEY HAD
A GRANT FOR LIFE PROGRAM.
WHICH IS SOMETHING I DIDN'T KNOW
EITHER.
SO THAT WOULD BE THE EXTREME
VERSION.
SO, THOSE ARE -- THAT IS NO
LONGER AROUND BUT THIS IS STILL
THE SAME CONCEPT.
SOMEHOW YOU WOULD GIVE SOMEONE
MORE LIKE HHMI SUPPORT.
SO, WE LOOKçi=b AT -- SO WE
TALKED
ABOUT THESE AND IN THE
COMMITTEE, THE COMMITTEE WASN'T
THAT KEEN ON THEM.
AND OURyt#/ STUDY SECTION
WASN'T
THAT KEEN ON THE CONCEPT.
THERE ARE OTHER KINDS OF WAYS TO
FOSTER INNOVATION THAT NIH USES
RIGHT NOW.
ONE OF THEM IS THE PIONEER AWARD
AND YOU HEARD OF THEM BEFORE I'M
SURE.
AND INó$pe FACT, WE HAD SEVERAL,
WE
HAVE BEEN THE SPONSOR OF SEVERAL
OF THESE PIONEER AWARDS AND
THESE ARE HIGH RISK, HIGH REWARD
KIND OF GRANTS.
HICH PEOPLE WORK IN AN ARE
A
INcj
THEY HAVEN'T WORKED IN BEFORE
BUT WANT TO.
SO IT'S A DIFFERENT KIND OF
RESEARCH BUT THEY HAVE SOME
BREAKTHROUGH IDEA
5 YEARS AT 500,000 DIRECT COST
PER YEAR AND THEY WRITE AN ESSAY
SO IT'S MODIFIED AND THEY DO AN
INTERVIEW BEFORE AWARDS ARE
MADE.
SO, THE NATIONAL INSTITUTE
OF DRUG ABUSE HAS USED THIS
MODEL AND DEVELOPED A PROGRAM
THEY CALL THE AVANT-GARDE
AWARDS.
THEY ANNOUNCED SERVE OR 8 NEW
AWARDS BAITED ON THE SAME MODEL.
THEY PICKED A AREA THEY WANT TO
SEE SOME DEVELOPMENT AND
BREAKTHROUGH IN AND THEN PUT
TOGETHER ONE OF THESE.
YOU HAVE TO DEVOTE A LOT MORE OF
YOUR TIME IF YOU GET ONE OF
THESE.
AND THE CASE OF THEPIONEER
AWARD FROM NIH, 51% IF YOU'RE
RESEARCH TIME HAS TO BE
COMMITTED TO THIS.
NIDA GAVE THEM A LITTLE MORE
BACK.
BUT STILL.
OTHER KINDS OF PERSON AWARDS
THAT ARE AVAILABLE TO US AS
MODELS IF WE WANT TO THINK ABOUT
THIS KIND OF AWARD.
ONE IS THE NIH MERIT AWARD.
THESE HAVE BEEN AROUND FOR A
LONG TIME.
A BUNCH OF INSTITUTES USE THESE,
PROBABLY HALF OR MORE OF THE
INSTITUTES GIVE MERIT AWARDS.
AND IN THIS CASE, SOMEBODY COMES
BACK WITH A COMPETITIVE RENEWAL
AND GETS A GREAT PERCENTILE.
THE PROGRAM STAFF CAN RECOMMEND
TO THEIR COUNCIL.
WE THINK THIS GUY OR WOMAN OUGHT
TO GET A MERIT AWARD AND THEN IF
THE COUNCIL AGREES, THE PI REACH
OUT TO THE PI AND SAY, SEND US
SOME INFORMATION ABOUT WHAT YOU
WOULD DO IF WE FUNDED YOU FOR
THREE MORE YEARS BEYOND THIS
GRANT.
AND SO, AS I POINTED OUT, 96
WERE AWARDED IN 2014 BY VARIOUS
INSTITUTES.
SO THIS IS PRETTY POPULAR WAY.
IT'S STILL PROJECT ORIENTED AT
THE BEGINNING.
z[.ZU THEN ALLOWS SOME
FLEXIBILITY
IF YOU ADD THAT EXTRA COUPLE OF
YEARS.
SO SOMEONE COULD GET AS MANY AS
EIGHT YEARS OUT OF ONE OF OF
THESE AWARDS BY GETTING THAT
SUPPLEMENTAL FUNDING.
AND THEN THERE IS THE NEW
DIRECTOR -- SO ALL OF THESE I
HAVE BEEN TALKING ABOUT IS FORRH
ANYBODY.
BUT THERE IS ALSO NEW INNOVATOR
AWARDS THAT ARE OFFERED BY NIH
LIKE THE PIONEER AWARD FOR EARLY
STAGE INVESTIGATORS.
THERE IS THAT CONCERN TOO THAT
FIRST RENEWAL OR THAT EARLY
PERIOD, AFTER YOU HAD YOUR FIRST
RO1 GRANT.
IF THERE IS STILL TENURE OR
WHATEVER UNIVERSITIES CALL IT,
HOW TO ASSURE SOME STATEMENTY
FOR A YOUNGéßJ INVESTIGATOR.
WE DON'T HAVE A PREFERENCE
NECESSARILY, ALTHOUGH WE FEEL
SYMPATHY FOR PEOPLE WHO ARE
ESIs.
I CAN'T SAY THEY UNDERSTAND HOW
THAT BENEFITS.
ONE OF YOU MIGHT KNOW BETTER
THAN I.
WHY IT WOULD BENEFIT TO THE PAY
THE ENTIRE AWARD UPFRONT?
>> SO JUST BACK TO THE REAL
WORLD OF OUR CURRENT RESEARCH
GRANT PROGRAMS, WE ARE BREAD AND
BUTTER RL1 AND R21 RESEARCH
PROJECT GRANTS AND THE
EXPERIMENTAL DEVELOPMENTAL
PROJECT.
AND YOU KNOW OUR PROGRAM IS
SMALL.
WE SPEND ABOUT THE LAST COUPLE
OF YEARS WE SPENT ABOUT 6 XpNñ
MILLION A YEAR AND WE FUNDED 30
NEW RESEARCH GRANT REQUESTS.
SO THAT IS JUST HOW THE LAST
COUPLE OF YEARS HAVE BEEN.
THE AVERAGE NEW RO1 RESEARCH
PROJECT GRANT WE GIVE CURRENTLY
IS ABOUT 400K TOTAL COSTS.
NOW THOSE OTHER NUMBERS I WAS
QUOTING WERE DIRECT COSTS.
SO THAT TELLS,IS CLOSER TO THE
MODULAR SIZE.
IT'S A SMALLER GRANT AND FOUR
RARELY GIVE A
FIVE-YEAR
YEARS WEÑ
GRANT.
RENEWALS SO WHEN PEOPLE COME
BACK IN A COMPETITIVE RENEWAL,
IF THEY GET AWARD, THEY ARE
USUAL I MORE COSTLY FOR US.
THE EXSPORE TORY DEVELOPMENTALS
AS YOU KNOW, THEY HAVE NIH
CEILING ON THEM.
WE DON'T MESS WITH THE MONEY.
THE APPLICANTS CAN ONLY ASK FOR
A CERTAIN AMOUNTS AND IF THEY
GET AWARD, THAT'S WHAT THEY GET.
AND WE GIVE THOSE.
SO WE FOCUS THIS PROGRAM IN
PARTICULAR, ON THE WAY OUT
STUFF.
EMPHASIZEDRS KNOW THAT.
INNOVATION IN ALL OF OUR
RESEARCH GRANTS BUT THIS
PARTICULARLY, AND BECAUSE PEOPLE
DON'T HAVE TO HAVE ADVANCE, OR
PRELIMINARY DATA FOR THESE.
THEY CAME FROM THEM BUT IT IS
ONLY TWO YEARS.
SO, YOU'RE WRITING THE NEXT
GRANT AS SOON AS WE SEND YOU THE
AWARD NOTICE.
IS THAT%&9ç RIGHT?
SO,!"séÑ WE HAVE SOMEOq+X
EXPERIENCE WITH
THESE OTHER INNOVATEIVATION
AWARDS AT NIH BECAUSE WE HAVE
MANAGED COUPLE OF THEM AND
COFUNDED.
SO, OUR FIRST PIONEER AWARDEE
JUST FINISHED HIS FIVE YEAR
PIONEER AWARD AND HOPING TO HAVE
HIM COME TALK NEXT TIME WE ARE
ALL HERE.
HE DID A COMPUTATIONAL MODELING
OF THE YEAST CELL.c,
A FULLY FUNCTIONING
COMPUTATIONAL MODEL.
AND WE HAVE TWOt1
THIS IS AN INTERESTING ONE WE
JUST PICKED UP LAST YEAR.
POTENTIALLY 3D PRINTING FOR BODY
PARTS IS HOW I WOULD PUT IT.
THAT'S NOT THE SCIENTIFIC WAY TO
PUT IT.
BUT INTERESTING TO THINK ABOUT.
SO I MENTIONED THIS BECAUSE WE
HAVE SOME EXPERIENCE WITH THOSE
AND THE OTHER THING I SHOULD
SAY, NIH EVALUATED ITS PIONEER O
WARD PROGRAM.
BY
TIME AND BELIEVES THAT ITúç?Pñ
IS
eikl HHMI FELLOW.
COMPARABLE TOSaqCLK
THE SUCCESS OF PEOPLE COMPARABLE
TO THAT.
SO WE TALKED ABOUT THE
INTERNALLY AND CONSIDERING THE
NATURE
ONE QUESTION YOU WOULD ASK IS,
Ñ
DOES OUR RESEARCH NEED A
PERSON!K
ORIENTED GRANT?
WE AGREE WE OUGHT TO KEEP THE
FOCUS ON IDEAS.
THAT IS THE CORE OF WHAT WE WANT
IS GOOD SCIEN
CE AND THAT
Tzfy
MEANS GOOD IDEAS.
IT CERTAINLY IS OUR EXPERIENCE
AND EVERYONE ELSE'S TALENTED
Z+ GET
INVESTIGATORS KNOW HOW TO
MONEY.
WE SHOULD ALWAYSW&[A KEEP THE
DOOR
OPEN TO EVERYONE BECAUSE THEY
ARE INVESTIGATOR INITIATED.
SO I THINK THAT IS WORK THAT HAS
BEEN A STRENGTH FOR US IN THE
PAST.
BUT IT MADE SENSE TO LOOK AT
SOME PROGRAM MODELS THAT EXIST
ALREADY.
WE CAN INVENT SOMETHING.
MEANWHILE, AND WE WERE JUST
ALLUDED TO EARLIER.
NIHkE
MEDICINE INITIATIVE OR THE
PRESIDENT ANNOUNCE TODAY AND NIH
HAS BEEN TALKING ABOUT IT.
AND SO, WHEN DON AND BETSY AND I
WERE TALKING ABOUT THE
POSSIBILITY OF A]=
HIGH-ENERGY GRANT LIKE A PIONEER
AWARD, THIS AREA WOULD TIE US
INTO WHAT IS GOING ON AND ALL
ACROSS NIH.
IT'S A HIGH PRIORITY AREA AND IT
SEEMED LIKE TO US, THIS IS ME
TALKING, PARTICULARLY IN
THIS=ielç
LONG-TERM GOAL.
PRESENT OF AREAS THAT SYNC WELL
LREADY HAVE INTERNALLY AND
Q
WITH THE RESEARCH EMPHASIS AREAS
EXTERNALLY.
I I AM NOT DESCRIBING/W
IN DETAIL BUT I WOULD SAY I
COULDYE
AN NLM PIONEER AWARD
COULD ISSUE/<
C MEDICINE.Cz÷%kÑ5
FOCUSED IN PRECISION
YOU HEARD BETSY SAY THAT NEW
MONEY AND DON SAY TOO, I
THINKOÑVÑ
THAT IN THE 2016 BUDGET, THERE
IS POTENTIALLY -- POTENTIALLY
NEW MONEY.
WE KNOW GRATES ARE AT ZERO SUM
GAME.
IF WE TAKE AND CREATE A NEW
GRANT PROGRAM, EITHER WE GET NEW
MONEY OR WE WILL STOP GIVING
SOMETHING ELSE OUT.
SO, I THINK THAT IS A>Qe
AND IT COULD GIVE US A REASON TO
PLAN SO THAT IF THE BUDGET COMES
THROUGH THE WAY IT IS DESCRIBED,
WE WOULD BE READY.
BU4p
RIGHT MODEL?
SOW"Ñ BRINGING THIS TO YOU SO
WE CAN HAVE A DISCUSSION OF IT.
WE WERE THINKING WE COULD HAVE A
PIONEERy.sGC MODEL WITH THAT ~ç
YEARS,
500,000.
YOU COULD DO LESS MONEY PER
YEAR.
BUT WE COULD START WITH THAT
OF AK?çUñ SIM
PLIFIED APPLICATION
IDEAa
THATe0peMnB#ç FOCUSES MORE ON A
PROGRAM
AND ESSAY WITH INTERVIEWS OF
DIFFERENT KINDS /GR8P RESEARCH
THAN
OUR TRADITIONAL ONES AND FOCUS
ON8fW9ñ THE INFORMATICS AREAS OF
PRECISION MEDICINE THAT FIT
WITHñw5yç
NLM'Só%)NT MISSION.
WE DISCUSSED THIS MOURNING
INNEi1ZU$E SUBC
OMMITTEE SO<
PEOPLE ARE HERE READY TO WEIGH
IN ON WHETHER THIS IS A GOOD OR
BAD DIRECTION TO GO.
Ã
Ñ YOU'RE
THAT'S WHAT I'M HOPING
GOING TO TELL US.
>> SO MANY PROS AND POTENTIALLY
SOME CONS AND WE SHOULD OPEN TO
Crjí
>> THINGS ARE +xI÷ CHANGING A
LITTLE
BIT
INFORMEDóOC=
[ INDISCERNIBLE ]
>> ONE AS APPROXIMATEECT THAT
DIDN'T COME UP IN ANY OF OUR
DISCUSSIONS, IS THIS GOING
(
BACKWARDS IN TERMS OF
÷
esy%÷c
÷#ñ RESEARCH?
COLLABORATIVE
BECAUSE THESE ARE_t NIGMS.
>> YOU HAVE TO GIVE BACK YOUR
MONEY 9fp
>> [ OFF MIC ]
>> YET I WOULD ARGUE THAT MUCH
OF THEk
INTERDISCIPLINARY TEAMS THESE
DAYS.
>> I WOULD AGREE AND AL%E WHEN
YOU'RE
OF THE KIND OF THINGS YOU'RE
TALKING ABOUT IN PRECISION8Uz
MEDICINE, IT HAS TO.
I MEAN, YOU JUST CAN'T DO8úñ IT
WITH ONE AREAfuI
YOU#y
GETTING THEHt3C DATA, NEED
7ZúLç BIOENGINEERS.
PHYSICIANS, NEED5"ú1W]ñ
STATISTICIANSl
>> DEVICEó=
IS THIS A GOODK[?
QUESTION?
>> SURE.
>> IT'S)
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>> IT SEEMS ALSOd
MONEY.FPí÷ THAT CAMEr
LONGITUDINAL CHILDREN'Sç
THAT ISó INVOLVELqoOESHA;
IU
AND THE PLANNING.tz
F THAT INITIATIVEPFHIS
Q5
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TO BUILD THIS
THAT INCLU
SOCIAL BUILDING DATA AND TO USE
UGs IT WITH OTHER
IT SHARE AND USEç#.
CENTERS IN ORDER TO DO THE KIND
OF RESEARCH WE ARE TALS0
ABOUT.
SO THAT DOESN'T SOLVE?-(
EVERYTHING.
ON THE SCIENCE OFFICER FOR IT,
WE OF COURSE PAY FORú>
SO --
>> I D÷ THINK IT
HANG YOUR CAREER ON THAT.
SOdD
LOOKING AT RIGHT ATúMo:4Lu THE
MOMENT.:
SO BIG DATA OR SMALLN
WHATEVER DATA.
SO SLOGANEERING IS NOT THE WAY
TO REALLY
TONIGHT, CELEBRATING FINISHING
OFF THE PROGRAM SCIENCE FOR
MICHAEL.
A LOT OF INTERESTING THINGS
ABOUT>
INTERESTED ME ISähnéce THATEgK
g HIS
SUPPORTED9R(Z
TESTIMONY AND SOp<
FACIAL HEART0()ñgLC
%uu@[(I(Q)TAI
N POINTPD AV
SO IT HAS TO AXVá>OAní
NIH
AND ITFlqî PRETTY
U
HAD TO --u
PR'TERVIEWS ANDw7"kl?Vmx
sgç A,8pQFBTp OF
ONE ISu:
DID0D;N YOUáCLH DO THIS?