>> ALL RIGHT, I THINK IT IS
10:00 RIGHT NOW SO I WANT TO
START ON TIME. GOOD MORNING,
WELCOME TO THE NATIONAL HEART
AND LUNG PULMONARY WORKPLACE
ENTITLED DISPARITY ACROSS
SPECTRUM OF PULMONARY DISEASE.
I'M DR. XIAO FOR THE PULMONARY
DISEASE ORGANIZING COMMITTEE
MEMBER FOR THIS WORKSHOP. ON
BE HALF OF THE WORKSHOP
ORGANIZATION COMMITTEE AND NHLBI
COMMISSION I WOULD LIKE TO
WELCOME EVERYONE TO THIS
IMPORTANT NHLBI WORKSHOP
RESEARCHING AREAS SUCH AS
DISPARITIES IN PVD. I WOULD LIKE
TO THANK EVERYONE FOR TAKING
YOUR PRECIOUS TIME TO
PARTICIPATE, ESPECIALLY FOR
SPEAKERS AND CO-CHAIRS AND
EVERYONE WHO HAS SPENT MANY
HOURS OF THEIR PERSONAL TIME
WORKING ON THE PRESENTATIONS. WE
APPRECIATE YOUR EFFORT AND
CONTRIBUTION TO THIS
WORKSHOP .ENTER ALSO I WANT A
SPECIAL THANKS TO OUR WORKSHOP
SUPPORT TEAM, ESPECIALLY JACKIE
AND HER SUPPORT TEAM, SHAUN, I
APPRECIATE YOUR WORK FOR SETTING
UP THE WORKSHOP. THANK YOU,
JACKIE AND THE SUPPORT TEAM FOR
WONDERFUL JOB WELL DONE. ANOTHER
IMPORTANT PEOPLE IS THE WORKSHOP
CO -CHAIRS. I THINK MOST OF YOU
ALREADY KNOW THEM. TWO
CO -CHAIRS ARE DR. RISCHARD FROM
UNIVERSITY OF ARIZONA AND ALSO
DR. LEOPOLD FROM BRIGHAM AND
HARVARD. THEY ARE THE MAIN
DRIVING WORKFORCE FOR THIS
WORKSHOP. REAL APPRECIATE YOU
GUYS. SO EVERYBODY HAS A CHANCE
TO DO A SELF-INTRODUCTION. IN
ORDER TO MAKE SURE WE STAY ON
TIME I'M ASKING EVERYONE JUST
TRY TO LIMIT YOUR INTRODUCTION
TO 15 SECONDS, AROUND THAT TIME.
LIKE A STUDY SESSION,
INTRODUCTION. NAME, TITLE,
INSTITUTION AND YOUR RESEARCH
INTEREST OR CLINICAL
SPECIALTIES, IF APPLICABLE. ONCE
YOUR NAME IS CALLED TURN DOWN
YOUR CAMERA AND MICROPHONE SO
YOU CAN START INTRODUCE
YOURSELF, OKAY. SO LET'S MOVE ON
TO THE ROSTER. STARTING WITH THE
TWO CO -CHAIRS, FRANZ.
>> HI, EVERYONE. GOOD MORNING,
THANKS FOR ATTENDING. I'M AT THE
UNIVERSITY OF ARIZONA, WHERE
I'VE BEEN HERE FOR ABOUT 25
YEARS. I'M THE DIRECTOR OF PH
AND ASSOCIATE DEAN OF CLINICAL
TRANSLATIONAL RESEARCH HERE. MY
RESEARCH INTERESTS LIE OUTSIDE
OF HEALTH DISPARITIES WITH
EFFECTIVE HISPANIC HEALTH
DISPARITIES, GIVEN OUR LOCATION
AND RV FUNCTION, COUPLING AND
EXERCISE PHYSIOLOGY. THANKS
AGAIN.
>> THANKS, FRANZ. JANE.
>> HI. I'M JANE LEOPOLD AT
BRIGHAM, HARVARD. 20 YEARS OR SO
HERE, A CARDIOLOGIST WITH
INTEREST IN PRECISION
PHENOTYPING WHICH HAS NOW
EXTENDED TO INCLUDE DISPARITIES
AND SOCIAL DETERMINANTS OF
HEALTH AS THEY AFFECT CLINICAL
PHENOTYPING. SO I WANT TO THANK
EVERYONE FOR ALL OF YOUR EFFORTS
YOU PUT INTO THIS AND WELCOME
YOU TO THIS GREAT WORKSHOP.
>> THANK YOU, JANE. NOW LET'S
INTRODUCE THE WORKSHOP SPEAKERS.
THOSE ARE THE NHLBI SPEAKERS. WE
WILL START WITH DR. GOEL.
>> HI, EVERYONE. MY NAME IS
KHUSHBOO GOEL, ASSISTANT
PROFESSOR OF MEDICINE AT
CEDARS-SINAI AND INTERESTS
INCLUDE IDENTIFYING MECHANISMS
OF PULMONARY MODELLING IN THIS
ANDER DISPARITIES AND IMPROVING
ACCESS TO CARE.
>> SORRY IF I MESSED UP THE
NAME.
>> NOT AT ALL.
>> CORRECT ME, I THINK I RUN
INTO THE SAME THING. THE NEXT IS
DR. ESTRADA.
>> GOOD MORNING, I'M RODOLFO
FROM SAN STOANTONIO AND MY INTET
LIES IN HISPANICS AS WELL. VERY
EXCITED TO BE PART OF THIS
WORKSHOP, THANK YOU.
>> NEXT, DR. SAHAY.
>> GOOD MORNING, SANDEEP SAHAY.
I HOPE TO --
>> TURN ON THE CAMERA.
>> I DID. CAN YOU SEE ME?
>> HERE NOW I CAN SEE.
>> OKAY. GOOD MORNING, EVERYONE.
THANK YOU FOR THE KIND
INVITATION. I'M SANDEEP SAHAY,
DR. OF PH PROGRAM AT HOUSTON AT
METHODIST, HOUSTON, TEXAS. MY
CLINICAL INTEREST, OF COURSE I'M
CLINICIAN AND MAINLY IN CLINICAL
TRIALS IN HYPERTENSION. I THINK
THAT IS WHERE I NOTICE
SIGNIFICANT DISPARITY OF THE
PATIENT POPULATION, CLINICAL
TRIALS. THAT DRIVES MY INTEREST
IN THIS TOPIC. I'M HAPPY TO BE
HERE AND PARTICIPATE IN THIS
WORKS
WORKSHOP.
>> HELLO, MY NAME IS HEATHER
STRAH, ASSOCIATE PROFESSOR OF
MEDICINE UNIVERSITY OF NEBRASKA
AND MEDICAL DIRECTOR LUNG
TRANSPLANT RESEARCH. MY INTEREST
IS PULMONARY MECHANICS IN
TRANSGENDER INDIVIDUALS.
>> THANK YOU, NEXT ONE, DR.
EGHB
EGHBALI.
>> THANK YOU, MY NAME IS
MANSOUREH EGHBALI AT UNIVERSITY
OF CALIFORNIA AND MY INTEREST IS
(?) AND SEX DIFFERENCE, IN
PARTICULAR ROLE OF ESTROGEN AND
SEX CHROMOSOME, THANK YOU.
>> THANK YOU, NEXT IS DR. COREY
VENTETUOLO.
>> I'M COREY VENTETUOLO,
PROFESSOR AT BROWN UNIVERSITY.
MY INTERESTS ARE IN SEXUAL
INTERESTS IN DIMORPHISM AND
HYPERTENSION.
>> I APOLOGIZE FOR YOUR NAME, A
TYPO ON THE SLIDE. I OVERLOOKED
THAT. THE NEXT IS DR. BERNARDO.
>> GOOD MORNING, BERNARDO (LOW
AUDIO)
>> ALL RIGHT, THANK YOU. NEXT
ONE IS DR. VINIVIO PEREZ, A
TYPO, I APOLOGIZE FOR THAT. YOU
THERE? PROBABLY STILL TOO EARLY
FOR HIM. THIS IS WEST COAST. SO
LET'S MOVE ON TO THE NEXT
SPEAKER. DR. BRITTAIN?
>> GOOD MORNING, I'M A
CARDIOLOGIST. I STUDY THE
MECHANISMS OF THIS INCLUDING THE
VETERAN'S AFFAIRS SYSTEM.
>> THANK YOU, EVAN. DR. GOLD.
DR. RACHEL GOLD, ARE YOU THERE?
ALL RIGHT. IT IS ALSO WEST
COAST. LET'S MOVE ON TO THE NEXT
ONE. DR. MARON. I BELIEVE YOU
ARE HERE ON THE EAST COAST.
>> HEY, EVERYONE, BRAD MARON,
PROFESSOR OF MEDICINE MARYLAND
AND EXECUTIVE CO -DIRECTOR FOR
INSTITUTE FOR HEALTH COMPUTING
HERE. I HAVE A BASIC AND
TRANSLATIONAL INTEREST IN
PULMONARY VASCULAR DISEASE AND
HEALTH DISPARITIES IN POPULATION
HEALTH.
>> THANK YOU, BRAD. NEXT ONE,
DR. LIM. IS DR. LIM HERE? I KNOW
HE FAMILY LEAVE NOW, BUT THAT IS
OKAY. THE NEXT SPEAKER, DR.
MATHAI. HE HERE? ALL RIGHT. SO
NOT YET. DR. DESAI.
>> THANK YOU, WELCOME, EVERYONE.
PROFESSOR OF MEDICINE AT INDIANA
UNIVERSITY AND CARDIOLOGIST.
RELATED TO THIS CONFERENCE I
(AUDIO INTERRUPTION)
>> THANK YOU, ANKIT. DR. ORTEGA.
>> I'M PROFESSOR OF MEDICINE AT
THE MAYO CLINIC, PULL MONDAY OL
GIST AND EPIDEMIOLOGIST AND LEAD
STUDIES FOR DIFFERENT NHLBI
NETWORKS BASED ON RARE AND
COMMON AIRWAY DISEASES WITH A
FOCUS ON ANCESTRAL DIVERSITY AND
RARE VARIANTS AND POLYGENIC RISK
SCORES AND ONE OF DIRECTORS OF
CENTERS FOR CENTER OF MEDICINE
AND RARE UNDIAGNOSED DISEASES
AND RISK IMPLEMENTATION.
>> THANK YOU. NEXT SPEAKER IS
DR. GLENN. IS DR. GLENN HERE? IF
NOT LET'S MOVE ON TO THE NEXT
SPEAKER. DR. HEMNES.
>> GOOD MORNING, ANNA HEMNES,
PROFESSOR OF MEDICINE AT
VANDERBILT SCHOOL OF MEDICINE.
I'M INTERESTED BROADLY IN HOW
SEX HORMONES MODIFY PULMONARY
VASCULAR DISEASE AND RIGHT HEART
RESPONSES.
>> THANK YOU, ANNA. THE NEXT
SPEAKER IS DR. HORN.
>> GOOD MORNING, EVERYBODY.
EVELYN HORN AT CORNELL AS
PROFESSOR OF MEDICINE AND
ADVANCE THE DEPARTMENT OF CARD
VALLECULAR DISEASE AND REALIZE
-- CARDIOVASCULAR DISEASE AND
RELEVANT TO THIS IN MIXED
DISEASE IN CARDIO-PULMONARY IN
IN MIXED SPACE AND IN GENDER.
>> I BELIEVE ALL THE SPEAKERS
ARE HERE, SOME ARE MISSING.
PROBABLY TOO EARLY ON THE WEST
COAST. WE WILL INTRODUCE THEM
WHEN THEY ARE HERE. NEXT WE WILL
GO TO THE NHLBI WORKSHOP
DISCUSSIONS. SO WE WILL START
AROUND THE LIST. SO DR. WAWUT.
>> I'M A PREFERENCE F PROFESS /
/* PROFESSOR AT PENNY AND
INTEREST IN SEXUAL DIMORPHISM
AND DISPARITIES AND EXCITED TO
BE HERE.
>> THANK YOU, STEVE.
>> GOOD EVENING, KARIM EL-KERSH.
I'M WITH THE UNIVERSITY OF
ARIZONA, PHOENIX CAMPUS.
DIRECTOR OF PH PROGRAM. MY
INTEREST IS IN SOCIAL
DETERMINANTS OF HEALTH AND
PALLIATIVE CARE IN HYPERTENSION,
ALSO WITH INTERESTS IN HEALTH
CARE UTILIZATION IN PULMONARY
HYPERTENSION. GLAD TO BE HERE.
>> THANK YOU. NEXT DR. TSUANG.
>> GOOD MORNING, THANK YOU. MY
NAME IS WAYNE. I'M ASSOCIATE
PROFESSOR AT THE CLEVELAND
CLINIC. I'M A TRANSPLANT PULL
MONDAY OL GIST AND INTERESTS IN
THE NEIGHBORHOOD EFFECTS ON
IN-STAGE CHRONIC LUNG DISEASES
AND EXCITED TO BE HERE.
>> DR. SAMAR FARHA AT CLEVELAND
CLINIC AND INTERESTED IN
HYPERTENSION AND HAVE BEEN
WORKING WITH DR. WAYNE AND
SOCIAL DISPARITY IN OUR
HYPERTENSION POPULATION. LOOKING
FORWARD TO LEARNING FROM ALL OF
YOU TODAY, THANK YOU.
>> THANK YOU. NEXT ONE IS DR.
NICKEL.
>> GOOD MORNING, MY NAME IS
(AUDIO DISRUPTION) -- BECAUSE WE
HAVE A MAJORITY OF HISPANIC
UNDERSERVED PATIENTS SO I'M
GRATEFUL TO BE PART OF THIS
WORKSHOP TODAY, THANK YOU.
>> THANK YOU. LAST DISCUSSANT IS
DR. ELWING.
>> THANK YOU, I'M EXCITED.
DIRECTOR OF MEDICINE THE
PULMONARY PROGRAM IN CINCINNATI.
MY FOCUS IS ON SOCIAL
DETERMINANTS OF HEALTH WITH A
SPECIAL INTEREST IN HOW RURALITY
AFFECTS OUTCOMES, SO THAT IS
WHAT AFFECTS MY PATIENTS, TO A
GREAT DEGREE.
>> ALL RIGHT, LET'S MOVE ON TO
THE INTRODUCTION OF MY NHLBI
COLLEAGUE. FIRST IS LEADERSHIP
FROM NHLBI, DR. GUSTAVO
MATUTE-BELLO, WHO IS THE ACTING
DIRECTOR FOR DIVISION OF LUNG
DISEASE. GUS.
>> SURE, I'M HAPPY TO BE HERE
AND THANKS FOR YOUR LEADERSHIP
AND FOR MAKING THIS POSSIBLE.
>> THANK YOU. THE BRANCH CHIEF,
LUNG DISEASE BRANCH CHIEF, DR.
JOHN SHERIDAN.
>> HELLO, THANK YOU FOR THE
INTRODUCTION. HI, EVERYONE.
LOOKING FORWARD TO THE
DISCUSSION. I JOINED NHLBI ON
THE LUNG DIVISION AS THE CHIEF
OF THE RESTRICTIVE AND VASCULAR
BRANCH A FEW MONTHS AGO, SO
LOOKING FORWARD TO DISCUSSION.
>> THANK YOU, JOHN. WE ALSO HAVE
OTHER COLLEAGUES HERE. I
PROBABLY DON'T HAVE THE TIME TO
INTRODUCE EVERYONE. WE WILL MOVE
ON TO THE NEXT. BASICALLY AGAIN
THANK YOU EVERYONE FOR STAYING
ON TIME. I WOULD LIKE TO WELCOME
OUR ACTING DIRECTOR OF THE
DIVISION OF LUNG DISEASE, DR.
GUSTAVO MATUTE-BELLO FOR THE
NHLBI LEADERSHIP PERSPECTIVE.
THANK YOU, GUS.
>> THANK YOU. GOOD MORNING,
EVERYBODY. AS ACTING DIRECTOR OF
DIVISION OF LUNG DISEASES AT
NHLBI, IT IS MY GREAT PLEASURE
TO WELCOME YOU ALL TO THIS NHLBI
WORKSHOP ENTITLED HEALTH
DISPARITIES ACROSS SPECTRUM OF
PULMONARY VASCULAR DISEASE, PVD.
THIS WORKSHOP WILL EXAMINE THE
RELATIONSHIP BETWEEN HEALTH
DISPARITIES AND PULMONARY
VASCULAR DISEASE, HOW THEY
AFFECT AND THE RELEVANCE OF
CARDIO PULMONARY VASCULAR
HEALTH. ONE OF THE KEYS IS
IDENTIFY FACTORS THAT ACCOUNT
FOR INDIVIDUAL DIFFERENCES AMONG
PEOPLE OF DIFFERENT SEX, GENDER,
RACE AND ETHNICITY IN TERMS OF
DISEASE PATHOBIOLOGY AND
TREATMENT. WE HAVE SIGNIFICANT
PROGRESS IN HEALTH DISPARITIES
AMONG MARGINALIZED GROUPS WITH
DISEASES LIKE HEART FAILURE AND
ASTHMA BUT LITTLE KNOWN HOW
AFFECT PATIENTS WITH PVD AND
GAPS INCLUDE UNDERSTANDING HOW
GENETICS AND PRECISION MEDICINE
SHOULD BE APPLIED TO RACIAL AND
ETHNIC GROUPS IN GROUPS AND O
HOW TO OPERATIONAL IZE BASED ON
SOCIAL DETERMINANTS OF HEALTH, A
FIELD OF SCIENCE. IT IS KNOWN
THAT SOCIAL DETERMINANTS OF
HEALTH ARE IMPORTANT
CONTRIBUTIONS (AUDIO DISRUPTION)
AND RELATIONSHIPS ARE NOT
KNOWN .ENTERIF WE WANT TO
DEVELOP AND DEFINE APPROACHES TO
PULMONARY HYPERTENSION SUCH
TAILOR THERAPIES WE NEED TO
UNDERSTAND INTERACTIONS BETWEEN
DISPARITIES AND PULMONARY
VASCULAR DISEASE, UNDERSTANDING
HOW SOCIAL DETERMINANTS OF
HEALTH AFFECT ANALYSIS OF THE
DATA AS WELL AS DEVELOPING NEW
APPROACHES TO ANALYZE GENETIC
DATABASE AND ANCESTRAL ORIGINS.
TO HELP US MOVE FORWARD THE
NHLBI WORKSHOP WITH GOALS OF
DISCUSSING THE STATE OF
KNOWLEDGE OF HEALTH DISPARITIES
AND IMPACT ON PVD, IDENTIFY
AREAS WHERE FURTHER RESEARCH IS
NEEDED AND EXPLORE NEW
INTERVENTIONS TO ADDRESS HOW
HEALTH DISPARITIES AFFECT PVD.
AT THIS TIME I WOULD LIKE TO ASK
OUR DOCTOR TO INTRODUCE DR.
LEOPOLD, THE CO -CHAIR TO
DISCUSS WORKSHOP GOALS AND
FUTURE OBJECTIVES, THANK YOU.
>> THANK YOU, GUS. I WENT
THROUGH THE SELF-INTRODUCTION
EARLIER SO WE WILL TRY TO STAY
ON TIME. NEXT WET WILL HAVE OUR
CO -CHAIRS, DR. RISCHARD, TO
GIVE US HIS PERSPECTIVE ON GOALS
AND FUTURE PERSPECTIVE.
>> THANK YOU DR. XIAO AND DR.
BELLO FOR THAT WELCOME. I WANT
TO THE GIVE A SPECIAL
INTRODUCTION AND REMIND EVERYONE
THAT IT IS COMING UP NOW ALMOST
NINE-YEAR ANNIVERSARY OF WHEN I
SAT DOWN WITH THE OTHER PVDOMIX
INVESTIGATORS. FOR THOSE WHO
DON'T KNOW IT IS AN
NHLBI-SPONSORED PROJECT. NINE
YEARS AGO WE SAT DOWN AND WENT
THROUGH THE PROTOCOL TOGETHER.
ALMOST A YEAR PROTOCOL. PVDOMIX
WILL BE HIGHLIGHTED LATER IN THE
SESSION. DR. LEOPOLD AND I MET
BACK THEN. I'M PROUD TO SAY AS
MUCH AS SHE IS A GREAT COLLEAGUE
AND EXPERT IN CARDIOVASCULAR AND
PH DISEASE, SHE IS A GREAT
FRIEND AS WELL. OUTSIDE THE
OBVIOUS I'M A WHITE MALE
CHAIRING A SESSION ON DIVERSITY.
MY IMPOSTER SYNDROME IS GOING IN
HIGH GEAR BECAUSE WE HAVE SO
MANY TALENTED -- 19 OTHER
SPEAKERS AND 6 EXPERT
DISCUSSANTS. SOMETIMES IT MAKES
ME NERVOUS WITH THE AMOUNT OF
BRAIN POWER WE HAVE THAT
CONFERENCE, BUT I'M VERY
EXCITED. THE DEPTH AND BREADTH
OF THE GROUP IS ASTOUNDING. WE
ARE ALL READY FOR A TREAT. ANY
ONLY ARE THEY DIVERSE IN SUBJECT
AREA AND EXPERTISE, DR. XIAO,
DR. LEOPOLD AND I MADE A
CONCERTED EFFORT TO BRING IN
PEOPLE OF DIVERSE GENDER,
RACIAL, ETHNIC AND CAREER LEVELS
AS WELL. WHAT WE WILL NOTICE IS
THERE ARE CROSS-CUTTING THEMES,
GENETICS, ENVIRONMENT,
VULNERABILITY AMONG OTHERS WITH
A LARGE FOUNDATION OF RESEARCH
OUTSIDE OF PH. THEREFORE YOU
WILL SEE A BODY OF EVIDENCE
PRESENTED IN THESE TOPICS THAT I
HAVE -- HAVE A -- HAVE GAINED
SOME REPETITION THROUGHOUT THE
CONFERENCE. BUT WILL OFFER
DIFFERENT PERSPECTIVES ON THAT.
OBVIOUSLY BECAUSE PH IS A RARE
DISEASE THERE IS NOT A LARGE
BREADTH OF EVIDENCE ON ASSOCIATE
DISPARITIES ON EVIDENCE SO,
AGAIN, WE HAVE A DIVERSE FACULTY
WHO WILL DISCUSS AREAS OUTSIDE
OF PH. BUT I THINK WE WILL ALL
DO A GOOD JOB OF BRINGING IT
BACK TO PH ON ALL THE DIFFERENT
SUBJECTS AND SESSIONS.
I THINK WE MUST RECOGNIZE
THAT THE IMPACTS THAT WE HAVE,
INTENDED OR UNINTENDED ON PUBLIC
POLICY AND GUIDELINE FOUNDATION
ARE IMPORTANT. ANNE RAND SAID
THE GREATEST THING SCIENCE
TEACHES IS LAW OF UNINTENDED
CONSEQUENCES. ONE THING THAT IS
IMPORTANT, I THINK, TO
ILLUSTRATE SOME OF THESE
UNINTENDED CONSEQUENCES ARE
SOMETHING THAT'S COME UP FAIRLY
REC
RECENTLY. TWO UNDERLYING
HYPOTHESES EXIST WHEN WE LOOK AT
ROLE OF RACE IN HEALTH
DISPARITIES. ONE ON THE TOP ON
THE LEFT YOU CAN SEE
TRADITIONALLY RACE HAS BEEN A --
CON FLATED WITH JEANETTE
HETEROGENAITY WITHIN RACE. THIS
HAS LARGELY BEEN DEBUNKED. THE
SECOND HYPOTHESIS IS STRUCTURAL
RACISM HAVING ROOTS IN POLICY AS
WELL AS DECISIONS IN THE -- DOWN
TO THE DECISIONS IN THE
COMMUNITY LEAD TO SOCIAL
DIVERSITIES AND OTHER THINGS
THAT LEAD TO HEALTH DISPARITIES.
ONE IMPORTANT EXAMPLE OF HOW
THE LINEAGE OF RESEARCH BASED IN
A LARGELY DEBUNKED HYPOTHESIS
MAY BE APPLIED TO CURRENT
RESEARCH IS IN A RECENT
PUBLICATION IN CHEST. EXERCISE
DYNAMICS PREDICT HYPERTENSION IN
MUTATION CARRIERS. FOR THOSE WHO
DON'T KNOW BM2R MUTATION IS ONE
OF THE MAIN MUTATIONS FOUND
RELATED TO PULMONARY
HYPERTENSION. THIS STUDY LOOKED
AT EXERCISE CATHETERIZATION TO
DETECT EARLY CHANGES AND
THEREFORE POTENTIALLY A MARK
TORE EXAMINE AND SCREEN FOR
FUTURE DEVELOPMENT OF PULMONARY
HYPERTENSION. IF YOU ARE NOT
FAMILIAR THIS IS OBTAINED
THROUGH EXERCISE
CATHETERIZATION. IF YOU MAY LOOK
AT THE LIST OF AUTHORS ON THIS
PAPER YOU REALIZE THIS GROUP IS
VERY INFLUENTIAL IN TERMS OF
WORLD SYMPOSIUM, GUIDELINE
FORMATION, AMONG OTHERS. ONE
THING THEY PERHAPS HAVE NOT
CONSIDERED IS BELOW THIS. THERE
WAS A STUDY IN 1985 LOOKING AT
THE DIFFERENCES BETWEEN WHITE
K
CAUCASIANS AND SUB SAHARAN
AFRICANS FROM BELGIAN GROUP AND
STUDIES THE PREMISE ONE CAN
HYPOTHESIZE BLACK
AFRICAN-AMERICANS -- NOT ONLY
LOOKING AT BLACK SUB SAHARAN
AFRICANS WHO HAVE LIVED IN
BELGIUM A SHORT PERIOD BUT CON
FLATING THAT WITH
AFRICAN-AMERICANS. THIS MADE
LESS CIRCULATION. WHEN WE LOOK
AT THE DIFFERENT FACTORS THAT
INFLUENCE DISTENSIBILITY, ONE OF
THOSE POTENTIALLY BEING WHETHER
OR NOT YOU ARE BORN AND RAISED
IN SUB SAHARAN AFRICA, WAS
PROBABLY AND LIKELY NOT
CONSIDERED BY THE GROUP THAT
LOOKED AT THE DISTENSIBILITY
HERE AMONG THE DETECT RESEARCH
GROUP, WHICH IS THE RECENTLY
PUBLISHED ARTICLE IN CHEST. THEY
ESSENTIALLY CUT OFF THE HEALTHY
SUB SAHARAN AFRICAN MEN IN
PREVIOUS STUDY ARE BELOW 1.5
BEST CUT-OFF FOR DEVELOPMENT OF
LATER PH. THIS MIGHT BE RINGING
SOME BELLS WITH REGARD TO HOW WE
HAVE RECENTLY BEEN DEBATING THE
ROLE OF RACE CUT-OFFS IN
SPIROMETRY. AND THIS SAME DEBATE
APPLIES NOW IN PULMONARY
HYPERTENSION, IF WE DON'T
EXAMINE WHAT POPULATIONS METRIC
HAS BEEN TESTED IN, PARTICULARLY
IN RACES, WHEN WE BRING THIS UP
AND SUBSEQUENTLY POTENTIALLY
GUIDELINE FORMATION, WE MAY
PERPETUATE EVEN UNKNOWINGLY
STRUCTURAL RACISM. CAN WE MOVE
TO THE NEXT SLIDE?
THERE WILL BE SEVERAL KEY
QUESTIONS WE WILL BE
APPROACHING. WITH A PASSION IN
THIS FIELD. WE WILL BE STARTING
OFF WITH DR. GOEL, DR. ESTRADA
AND DR. HAY. DOCTORS BERNARDO,
JESUS, PEREZ, BRITAIN WILL
DISCUSS SOCIAL DETERMINANTS OF
HEALTH, HEALTH IN PH PATIENTS
AND DR. GOEL WILL BE FINISHING
OFF WITH SOCIAL DETERMINANTS OF
HEALTH IMPLEMENTATION RESEARCH.
DR. SHAH WILL DISCUSS SEX AND
GENDER DISPARITIES, DR. EGHBALI
SOME BASIC SCIENCE ON SEX
HORMONES AND DR. VENTETUOLO WILL
FINISH OFF WITH INTERVENTIONS
AIMED AT THESE DISPARITIES. DR.
DEASI WILL GIVE A LOOK WITH HOW
GENETICS INTERACT WITH
ENVIRONMENTAL FACTORS AND I LOOK
FORWARD TO DR. ORTEGA PROVIDING
OVERVIEW OF GENETICS AND
ANCESTRY, PARTICULARLY RELEVANT
TO THE PREVIOUS SCENARIO I JUST
DISCUSSED. DR. GLENN WILL GIVE
US AN IDEA ON HOW CUMULATIVE
STRESS, TRAUMA IS MEASURED BY
ALOE STATIC LOAD AFFECTS OUR
HEALTH AND DR. LIM AND MATHAI ON
ENVIRONMENTAL EXPOSURES
DISPROPORTIONATELY FELT BY
MARGINALIZED COMMUNITIES AND
WAYS TO MITIGATE BY DR. MATHAI
AND LOOK BACK AT MY COLLEAGUES
IN THE STUDY, MYSELF, HORN AND
HEMNIS DISCUSS THE RACIAL AND
AGE-RELATED ISSUES FROM THE
PVDOMIX STUDY. YOU WILL NOTICE
YOU WILL HAVE FIVE MINUTES FOR
DISCUSSION. THIS IS MOSTLY FOR
TRANSITION. WE WILL HAVE A
20-MINUTE INTERVAL TO ALSO
DISCUSS IN A TWO-HOUR DISCUSSION
SESSION AT THE END OF THE SECOND
D
DAY. WE ARE TALKING ABOUT RACE,
ETHNICITY AND GENDER AND THESE
CAN BE CHARGED. I WOULD URGE YOU
TO CRITICIZE POLICIES RATHER
THAN INDIVIDUALS. LASTLY WE WILL
BE DEVELOPING A WORKSHOP
MANUSCRIPT. IF YOU HAVE IDEAS,
EMAIL ME, SEND COMMENTS IN CHAT
OR TEXT OR PING ME WITH THOSE
IDEAS. WITH THAT LET'S GET
STARTED. I WILL INTRODUCE DR.
GOEL, GIVING US A TALK ON THE
RELATIONSHIP BETWEEN HEALTH DIRT
DISPARITIES, RACE, ETHNICITY AND
ANDING ACCENTUATED BY RARE
DISEASES LIKE PH.
>> I SEE SOME OF THE SPEAKERS
ARE HERE, MISSING FROM THE
INTRODUCTION SECTION. MAYBE WE
WILL ASK THEM TO DO A QUICK
SELF-INTRODUCTION FIRST BEFORE
THE SESSION START. I SEE DR.
GLENN AND DE-JESUS. MAY BE MORE.
DR. GLENN, IF YOU ARE HERE YOU
TURN ON YOUR CAMERA AND
MICROPHONE AND GIVE A 15-SECOND
SELF-INTRODUCTION. BASICALLY --
YEP.
>> GOOD MORNING. I'M JASON GLENN
ASSOCIATE PROFESSOR IN
DEPARTMENT OF HISTORY AND
PHILOSOPHITY AT DEPARTMENT OF
MEDICINE AT UNIVERSITY OF KANSAS
MEDICAL CENTER AND ALSO
ASSOCIATE DIRECTOR OF CENTER FOR
AFRICAN-AMERICAN HEALTH. IT IS
WONDERFUL TO BE WITH YOU ALL
THIS MORNING.
>> THANK YOU, DR. GLENN.
VENICIO, ARE YOU HERE?
>> CAN YOU HEAR ME?
>> YES, I CAN HEAR YOU.
>> WONDERFUL. I'M AT THE STAFF
UNIVERSITY AND SPECIALIZE IN
PULMONARY HYPERTENSION AND HAVE
INTEREST IN DRUG INDUCED
HYPERTENSION AND SOCIAL
DETERMINANTS OF HEALTH.
>> THANKS, VENICIO. NOT SURE
WHETHER DR. GODE AND MATHAI ARE
HERE. IF YOU ARE PUT ON YOUR
MICROPHONE AND PROCEED. PROBABLY
NOT HERE. LET'S MOVE ON TO DR.
GOEL TO START HER PRESENTATION,
THANK YOU.
>> PERFECT. HI, EVERYONE. I
REALLY APPRECIATE THE
OPPORTUNITY TO SPEAK WITH YOU
ALL TODAY.LY BE DISCUSSING HOW
DISPARITIES ASSOCIATED WITH RACE
AND ETHNICITY ARE ACCENTUATED
AMONG PATIENTS WITH PULMONARY
VASCULAR DISEASE AND
SPECIFICALLY ON PULMONARY
HYPERTENSION.LY START WITH A
RARE DISEASE SUCH AS PH AND INTO
THE ROLE RACE AND ETHNICITY PLAY
IN PERPETUATING THESE HEALTH
CARE DISPARITIES. I WILL TALK
ABOUT AN IMPORTANT MANIFESTATION
CONSEQUENCE DISPARITIES,
UNDERREPRESENTATION IN PH
REGISTRIES AND CLINICAL TRIAL.
THEN GET INTO FUTURE DIRECTIONS
AND QUESTIONS. ONE OF MY BIG
GOALS FOR THIS TALK IS TO SET
THE STAGE FOR ALL THE SUBSEQUENT
TALKS, WHICH WILL DELVE DEEPER
INTO TALKS I BRING UP TODAY.
NEXT.
I DID WANT TO START OFF WITH
THE STORY OF ONE OF MY PATIENTS.
SO HE IS A 58 -YEAR-OLD MAN WITH
HISTORY OF METH AND ADMITTED
WITH SEPTIC SHOCK. HE HAD AN
ECHO CARD GRAM, WHICH WAS
CONCERNING FOR PH. HE ENDED UP
NEEDING A CATHETER, SHOWING
ELEVATED ARTERY PRESSURE. HE WAS
DIRE EASED, NEEDED ANDOBUTAMINE
AND IVOPROSTENAL. HE WAS ABLE TO
SAFELY UNDERGO SURGERY AND
TRANSFERRED TO CEDARS FOR
FURTHER MANAGEMENT OF PH. WHEN
HE CAME TO WE CONTINUED TO
DIURESE AND WEAN HIM OFF AND
WORK UP FOR CAUSES OF PH, AFTER
WHICH WE PERFORMED A FORMAL
RIGHT HEART CATEGORY IZATION
WHICH DID CONFIRM PRECAPILLARY
PH AND WE WERE ABLE TO START HIM
AS AN INPATIENT ON SILDYNAFIL.
GREAT NEWS IS EVERYTHING
IMPROVED DURING HIS HOSPITAL
STAY. NEXT. SO THIS REALLY FELT
LIKE A SUCCESS STORY. THIS,
AGAIN, IS A GREAT EXAMPLE OF
PEOPLE RECOGNIZING PH AND
APPROPRIATELY TRANSFERRING TO AN
EXPERT PH CENTER, WHICH ALLOWED
US TO COMPLETE A THOROUGH
WORKUP. ULTIMATELY INITIATE
TREATMENT DIRECTED AT PAH. NEXT.
THEN, YOU KNOW, AFTER WE
FINISHED GIVING HIGH-FIVES AND
PATTING OURSELVES ON THE BACK WE
HAD TO THINK WHERE DO WE GO FROM
HERE, WHAT ARE THE NEXT STEPS.
REALLY THE NEXT STEP WAS TO
START COORDINATING OUTPATIENT PH
FOLLOW-UP SO TO FOLLOW HIM
CLOSELY AND CONTINUE TO ADD ON
DIFFERENT MEDICATIONS. NEXT.
BISHOP, CALIFORNIA IS CLOSER TO
THE STATE OF NEVADA THAN IT IS
TO ANY OTHER MAJOR CITY IN
CALIFORNIA. FOR HIM TO COME TO
S
CEDARS WOULD BE FOUR HOURS, NOT
INCLUDING L. A. TRAFFIC. NEXT.
SO WHEN WE SEARCHED ON THE
WEBSITE TO LOOK FOR OTHER PH
SPECIALISTS IT RESULTED IN FOUR
PH SPECIALISTS. INTERESTINGLY
ENOUGH, IT WOULD HAVE BEEN AN
EVEN LONGER DRIVE IF HE HAD TO
GO TO FRESNO OR SACRAMENTO,
WHERE THEY WERE LOCATED. NEXT.
FORTUNATELY HE WAS SOMEHOW ABLE
TO MAKE THE LONG DRIVE TO L. A.
TO BE SEEN, WHICH WE WERE ABLE
TO INITIATE MASETINTIN.
INSURANCE CHANGED AND REQUIRED
AUTHORIZATION, WHICH CLASSICALLY
WAS DENIED, RAN OUT IN THE
INTERIM AS WELL, WHICH WAS
CONCERNING. AFTER A FEW MONTHS
HE WAS EVENTUALLY ABLE TO BE
APPROVED AT USC. SO THERE IS A
BIT OF A HAPPY ENDING TO THIS.
NEXT. SO I'M SURE THIS STORY
SOUNDS FAMILIAR BECAUSE I THINK
IT HIGHLIGHTS A LOT OF COMMON
THEMES WE FACE AND SEE. FOR
EXAMPLE, THE FACT THERE IS
VARYING DEGREE OF RESOURCES AND
EXPERTISE TO PROVIDE SPECIALIZED
PH CARE. THERE IS A LIMIT TO HOW
MUCH WE CAN OPTIMIZE ON THE
INPATIENT SIDE. AT SOME POINT WE
HAVE TO LET THEM OUT INTO THE
REAL WORLD. ISSUES OF SAFE
DISCHARGE AND FOLLOW-UP PLANS,
PRESCRIBING AND MONITORING VASO
DILATOR THERAPY, INSURANCE
BARRIERS AND SUBSTANCE USE
DISORDER AS A CAUSE OF PH. NEXT.
THIS IS WHERE WE GET INTO SOME
SAD FACTS ABOUT CARING FOR
PATIENTS WITH A RARE DISEASE
SUCH AS PH. FIRST AND FOREMOST
IS THE FACT WE STILL -- TAKES
PATIENTS A LONG TIME TO GET
DIAGNOSED WITH PH. THE TIME TO
DIAGNOSE IS STILL OVER ONE YEAR.
A STUDY HAS SHOWN APPROXIMATELY
21 PEREZ OF PATIENTS HAD TO LIVE
WITH SYMPTOMS MORE THAN TWO
YEARS BEFORE GETTING A
DIAGNOSIS.
YOU KNOW, CERTAINLY THIS CAN
STEM FROM THE FACT PH HAS PRETTY
NON-SPECIFIC SYMPTOMS. ALSO
THERE IS STILL A LACK OF
AWARENESS ABOUT PH. SO PROVIDERS
MAY, YOU KNOW, MISS THE
DIAGNOSIS OF PH BECAUSE THEY ARE
THINKING OF MUCH MORE COMMON
DISEASES SUCH AS OBESITY, HEART
FAILURE. THE FLIP SIDE IS SOME
PATIENTIES CAN GET MISDIAGNOSED
WITH PH BASED ON ECHO CARD
GRAMS, ENLARGED PULMONARY ARTERY
ON THE SCAN. THAT TOO WITHOUT
THE FORMAL GOLD STANDARD
DIAGNOSTIC TEST, WHICH IS A
RIGHT HEART CATEGORITIZATION,
RESULTING GETTING STARTED ON
SURVEY SEW D SURVEY SOE /* /* V
DILATOR THERAPY, WHICH HAS ME
WORKING BACKWARDS. THERE IS A
STUDY THAT SHOWED 6 PER% HAD
UNDERGONE ALL THE SCREENS, SUCH
AS AUTO IMMUNE, H.I.V.,
HYPERTENSION, VQ SCANS, ALL THE
WORKUP TO APPROPRIATELY
PHENOTYPE BECAUSE THAT IS
ULTIMATELY HOW WE DETERMINE THE
TREATMENT APPROACH. NEXT. THE
NEXT BARRIER IS EVEN IF THEY
HAVE GOTTEN A DIAGNOSIS OR PH OR
HAVE HIGH SUSPICION THEY MAY NOT
HAVE ACCESS. OR DON'T HAVE AN
ACCREDITED CENTER. HAVING SAID
THAT THERE ARE STILL PLENTY OF
EXPERT CENTERS THAT DON'T HAVE
THAT FORMAL ACCREDITATION. BUT
MAY STILL BE A LACK OF AWARENESS
IN COMMUNITY KNOWING WHAT ARE
EXPERT PH CENTERS IN MY REGION,
THUS WHO DO I ACTUALLY REFER TO.
NEXT. THEN FINALLY WE HAVE TO
THINK ABOUT EVEN PATIENTS WHO
HAVE MADE THEIR WAY AND GOTTEN
THEMSELVES TO AN EXPERT PH
CENTER THERE IS A TREMENDOUS
BURDEN. FIRST AND FOREMOST FROM
A FINANCIAL PERSPECTIVE. ONE
STUDY SHOWED THE COST PER
PATIENT PER MONTH IS FOUR TO
FIVE TIMES HIGHER FOR PATIENTS
WITH PULMONARY
ARTERIAL HYPERTENSION COMPARED
TO PATIENTS WITHOUT PAH, EVEN
AFTER MATCHING FOR AGE, SEX,
GEOGRAPHICAL AREA AND ANNUAL
INCOME. THIS FINANCIAL BURDEN
COMES IN THE MANIFESTATION OF
THE COST OF MEDICATIONS, EVEN IF
THEY HAVE PRIVATE INSURANCE, TO
THE POINT WHERE MAYBE PATIENTS
HAVE TO START PICKING AND
CHOOSING WHICH MEDICATIONS AND
NOT BEING ADHERE RENT WITH THEIR
REGIMEN. THE COST OF FREQUENT
AND LONG HOSPITALIZATIONS, ALL
THE TESTING THEY HAVE TO UNDERGO
AND FREQUENT OFFICE VISITS THEY
HAVE TO GO TO.
ALSO THE EMOTIONAL BURDEN OF
LIVING WITH PH DUE TO THE
SYMPTOM BURDEN, DUE TO THE FACT
IT TAKES ON THEIR FUNCTIONAL
STATUS AND ALSO FOR T CARRYING
PEEM /* /* CAREGIVERS AND PEOPLE
THAT SUPPORT THEM. I HOPE I HAVE
PROVEN THE OBSTACLES PATIENTS
HAVE TO OVERCOME TO RECEIVE
HIGH-QUALITY PH CARE. NOW WHAT
HAPPENS WHEN WE ADD THE ISSUE OF
HEALTH DISPARITIES TO THE
EQUATION. THIS WAS THE
DEFINITION ADOPTED BY THE ATS
HEALTH EQUITY SUBCOMMITTEE. THEY
DEFINED RESPIRATORY HEALTH
DISPARITIES AS SIGNIFICANT
DIFFERENCES IN RESPIRATORY
HEALTH CLOSELY LINKED TO RACIAL
ANCESTRY, SOCIOECONOMIC AND/OR
ENVIRONMENTAL DIFFERENCES AND
EXPLAIN HEALTH DISPARITIES
AFFECT GROUPS WHO HAVE
EXPERIENCED GREATER OBSTACLES
BASED ON RACIAL AND ETHNIC
GROUPS, WHICH I WILL FOCUS ON,
RELIGION, SOCIOECONOMIC STATUS,
GENDER, SEXUAL ORIENTATION OR
IDENTITY, MENTAL HEALTH,
DISABILITIES AND OTHER
CHARACTERISTICS HISTORICALLY
LINKED TO DISCRIMINATION OR
EXCLUSION.
NOW I DO WANT TO START WITH
OF COURSE ACKNOWLEDGING RACE IS
A SOCIAL CONSTRUCT AND IT IS
DIFFICULT TO CATEGORIZE AND
DEFINE PEOPLE INTO SPECIFIC
BOXES OF RACE OR ETHNICITY. THE
FACT THERE IS A SIGNIFICANT OF
INTER PLAY OF THER FACTORS SUCH
AS SOCIOECONOMIC STATUS, WHICH
SUBSEQUENT TALKS WE WILL GET
INTO. EVEN THEN THERE IS A GOOD
AMOUNT OF DATA TO SHOW THAT RACE
AND ETHNICITY CAN CERTAINLY
EXACERBATE HEALTH DISPARITIES
AND PH, ON TOP OF THIS ALREADY
CHALLENGING PATHWAY WE HAVE
TALKED ABOUT THAT PH PATIENT S
HAVE TO NAVIGATE TO GET CARE. SO
WHEN WE TALK ABOUT DIAGNOSIS A
PERSON'S RACE MAY COMPLICATE
THIS BECAUSE PEOPLE WITH OTHER
RACES OR MINORITIES MAY LIVE IN
MEDICAL DESERTS, WHERE THEY HAVE
EVEN MORE LIMITED ACCESS TO
PRIMARY CARE PHYSICIANS AND EVEN
MORE LIMITED ACCESS TO
PULMONOLOGIST AND CARDIOLOGISTS
WHO MAY BE THE FIRST PIECES OF
THE PUZZLE OF DIAGNOSING PH.
RACE, ETHNICITY AND INCOME ARE
ASSOCIATED WITH SEVERITY AND
THIS CAN MAKE A BIG IMPACT ON
MORTALITY. A STUDY SHOWED BLACK
AND HISPANIC WERE IN THE TWO
LOWEST INCOME CATEGORIES AT A
HIGHER FREQUENCY. PATIENTS IN
THESE LOWER INCOME CATEGORIES,
THERE WAS A MUCH HIGHER
PERCENTAGE OF PATIENTS WITH
FUNCTIONAL CLASS 3 AND 4
SYMPTOMS. NEXT.
AGAIN WHEN WE TALK ABOUT
GETTING TO AN EXPERT PH CENTER
THIS CAN BE IMPACTED BY RACE OR
ETHNICITY. IT MIGHT CONTRIBUTE
TO FINANCIAL STATUS, INSURANCE
STATTY IS. WHEN WE TALK ABOUT
TRANSPORTATION NOT ONLY IS IT A
LONG COMMUTE BUT WHAT IF THEY
RELY ON PUBLIC TRANSPORTATION
AND WHAT IF THEY HAVE HOUSING
INSECURITY? I THINK EVERYONE ON
THE CALL KNOWS AND APPRECIATES
THERE ARE SIGNIFICANT
CONSEQUENCES TO NOT HAVING
ACCESS TO AN EXPERT PH CENTER.
THEY CAN ACUTE DECOMPENSATED
RIGHT HEART FAILURE, I THINK
FROM A CRITICAL CARE PERSPECTIVE
IS ONE OF THE MOST FRIGHTENING
PROBLEMS TO DEAL WITH. FOR
PATIENTS WHO HAVE -- ARE ON
THERAPY, THEY MIGHT GET ADMITTED
INTO A HOSPITAL THAT HAS LIMITED
EXPERIENCE AND EXPOSURE TO
CARING FOR PATIENTS WITH PROSTA
PUMPS AND KNOWING HOW TO
TROUBLESHOOT OR MAY NOT HAVE THE
PULMONARY VASO ON THE PATIENT
FO
FORMULARY. IN DAYS WHERE ACCESS
TO REPRODUCTIVE HEALTH IS PRETTY
LET HETEROGENOUS AT BEST. WHEN
SOMEONE IS ABLE TO GET TO A PH
CENTER I THINK WHAT IS
CONCERNING IS PATIENTS CAN STILL
RECEIVE DIFFERENT TREATMENT
PATTERNS OR EXPERIENCE
DIFFERENCES IN TREATMENT
PATTERNS BASED ON THEIR RACE AND
ETHNICITY. A LOT MAY COME FROM
PERCEIVED CONCERNS ABOUT HEALTH
LITERACY, MEDICATION ADHERENCE,
SOCIAL SUPPORT, LANGUAGE
BARRIERS. YOU KNOW, THESE
MEDICATIONS ARE SO SPECIALIZED
AND REQUIRE A LOT OF FOLLOW-UP
AND EDUCATION AND TEACHING.
THERE WAS AN INTERESTING STUDY
PUBLISHED BY DR. GROVES AND
COLLEAGUES WHO SHOWS THAT BLACK
PATIENTS WERE ACTUALLY 36 PEREZ
LESS LIKELY -- 36 % LESS LIKELY
TO RECEIVE THERAPY. THEY FOUND
THAT BLACK PATIENTS HAD LOWER
TREATMENT ADHERENCE. WHEN THEY
ARE PRESENTING THIS IN AN
ABSTRACT FORM AT A CONFERENCE, I
REMEMBER THEY ALSO HAD SOME DATA
WHICH SUGGESTED THAT HISPANIC
PATIENTS WERE LESS LIKELY TO
RECEIVE PROSTACYCLYN
MEDICATIONS. NEXT. WHAT I FIND
UNACCEPTABLE IS THERE CAN BE
DIFFERENCES IN OUTCOMES BASED ON
RACE OR ETHNICITIES. I THINK ONE
OF KEY EXAMPLES IS IT'S BEEN
SHOWN BLACK PATIENTS HAVE
INCREASED RISK OF DEATH, EVEN
AFTER ADJUSTING FOR AGE AND
FUNCTIONAL CLASS. SOME STUDIES
HAVE SHOWN DIFFERENCES IN
SURVIVAL RATES IN HISPANIC
POPULATION WERE NOT ABLE TO
ADJUST FOR DIFFERENCES IN
SOCIOECONOMIC STATUS.
SO I THINK ONE OF THE KEY
MANIFESTATIONS OF HEALTH
INEQUITY PERPETUATED BY RACE AND
ETHNICITY IS LACK IN INDUSTRIES
AND RANDOMIZED CONTROL TRIALS,
WHICH IS REALLY THE FOUNDATIONS
OF WHAT IS KNOWN ABOUT
EPIDEMIOLOGY IN PH AND ALSO
SERVE TO LAYOUT REALLY WHAT ARE
TREATMENT ALGORITHMS ARE.
SO THIS IS A TABLE OF FOUR
MAJOR REGISTRY USE FOR PH. THE
TAKEAWAY IS THEY ARE PRIMARILY
INCLUDING WHITE PATIENTS. WHEN
WE LOOK AT THE U.S. REVEAL
REGISTRY, THERE IS A SIGNIFICANT
UNDERREPRESENTATION OF ASIAN AND
PACIFIC ISLANDERS COMPARED TO
THE U.S. CENSUS DATA. I HAVE TO
POINT OUT AT LEAST IT HAS A
SLIGHTLY HIGHER REPRESENTATION
OF BLACK AND HISPANIC PATIENTS.
NEXT.
THIS UNDERREPRESENTATION OF
CERTAIN RACES AND ETHNICITIES IS
MAGNIFIED ON AN INTERNATIONAL
SCALE BECAUSE MOST DATA IS
ACTUALLY COMING FROM THE UNITED
STATES AND EUROPE. THE PDRA
REGISTRIES IS AN EXCITING
INITIATIVE BECAUSE IT IS TRYING
TO CREATE A WORLDWIDE AND HIGHLY
PHENOTYPES REGISTRY. THEN SO FAR
THE MAJORITY OF CENTERS ARE
STILL FROM AMERICA AND EUROPE.
NEXT.
THERE IS A FURTHER
DISCORDANCE BETWEEN REGISTRY
ENROLLMENT AND CLINICAL TRIAL
ENROLLMENT. THIS IS A LIST OR
GRAPH OF PIVOTAL TRIALS IN PH.
ONE OF THE LARGEST TRIALS TO
DATE IS THE GRIFFIN TRIAL, WHICH
DID NOT PUBLICLY PUBLISH THE
RACIAL BREAKDOWN -- ETHNIC
BREAKDOWN OF THAT. THIS IS A
CONSEQUENCE OF FACT THAT, IN
PART, MOST OF THESE TRIALS ARE
ENROLLING IN THE UNITED STATES,
EUROPE AND AUSTRALIA. THERE IS A
SIGNIFICANT -- IN COMPARISON,
UNDERREPRESENTATION OF CENTERS
FROM SOUTH AMERICA, ASIA AND
AFRICA. ALSO THIS LACK OF
REPRESENTATION IN CLINICAL
TRIALS IS, AGAIN, A CONSEQUENCE
OF, YOU KNOW, MANY ROOT CAUSES
COMING TOGETHER. YOU KNOW, SOME
OF WHICH ARE ASSOCIATED WITH
SOMEONE'S RACE AND ETHNICITY.
NEXT. THIS IS COMING FROM AN
ANALYSIS OF 18 PHASE-3 RAN
MINORITIZED CONTROLLED TRIALS.
THE TAKE AWAY IS THEY ARE
SHOWING THE TRIALS EARLIER ON
WERE PREDOMINANTLY ENROLLING IN
WESTERN COUNTRIES AND INCLUDED
NON-HISPANIC WHITE PATIENTS.
THOUGH THE PROPORTION HAS
SLIGHTLY DECREASED OVER TIME
WITH INCLUSION OF NON-WESTERN
COUNTRIES. NEXT. THE QUESTION IS
HOW ARE WE DOING NOW? WE ARE IN
A GREAT SPACE WHERE WE HAVE HAD
THREE TRIALS COME OUT IN THE
LAST FEW YEARS. BUT ANSWERS
UNFORTUNATELY IN TERMS OF
REPRESENTATION, ABOUT THE SAME
IF NOT SLIGHTLY WORSE WITH THE
TRIALS HAVING OVERWHELMING
MAJORITY OF WHITE PATIENTS AND
TRIAL LOOKING AT COME NATION PD5
AND ERA PILL WAS NOT THE MOST
CLEAR IN TERMS OF PUTTING OUT
THE RACIAL AND ETHNIC BREAK DOWN
OF THAT TRIAL. NEXT.
AGAIN, REALLY IMPORTANT,
THERE ARE CONSEQUENCES OF BEING
UNDERREPRESENTED IN CLINICAL
TRIALS BECAUSE IT CHALLENGES THE
INTERNAL AND EXTERNAL VALIDITY
OF TREATMENT GUIDELINES AND CAN
CONTRIBUTE TO UNEQUAL ACCESS TO
NOVEL THERAPIES AND ULTIMATELY
MAY AFFECT OUTCOMES, IN PART,
BASED ON RACE AND ETHNICITY.
NEXT. SO REALLY THE TAKE AWAY IS
GETTING ACCESS TO SPECIALIZED
AND EQUITABLE PH CARE IS NOT AS
SIMPLE AS A REFERRAL. BECAUSE,
AS I HAVE TALKED ABOUT, THERE
ARE MULTIPLE FACTORS THAT PLAY A
ROLE IN JUST GETTING REFERRED TO
A PH CENTER. SOMEONE'S RACE AND
ETHNICITY CAN IMPACT THOSE
FACTORS. EVEN AFTER GETTING IN,
PATIENTS CAN FACE IMPLICIT
BIASES FROM HEALTH CARE
PROVIDERS PERHAPS DUE TO RACE
AND ETHNICITY DUE TO REGISTRIES,
ACCESS TO CLINICAL TRIALS, THIS
CAN AFFECT TREATMENT PATTERNS,
POTENTIALLY OUTCOMES AND PER PCH
WAITS -- PERPETUATES A VICIOUS
CYCLE. NEXT. THE REASON I THINK
WE ARE ALL HERE IS WE ARE TRYING
TO MOVE FROM THIS IDEA OF
EQUALITY, TRYING TO ACHIEVE
EQUITY AND ULTIMATELY ACHIEVE
JUSTICE OR REMOVE THE BARRIERS..
THIS WAS THE BLUEPRINT FOR
ACTION IN 2017, TALKING ABOUT
COMMON THEMES AND CAPTURING
INFORMATION ABOUT RACE AND
ETHNICITY AND SOCIOECONOMIC
STANDARDS, EDUCATION,
PARTNERSHIP, YOU KNOW,
INCREASING AWARENESS ABOUT
IMPLICIT AND UNCONSCIOUS BUY
YES,
BIASES AND FOCUSSING ON CULTURAL
LANGUAGE APPROPRIATE SERVICES.
NEXT.
THERE ARE CERTAINLY MANY
UNMET NEEDS IN HEALTH
DISPARITIES IN PH, BUT I THINK
WITH THE RESOURCES, LIKE I HAVE
OUTLINED HERE. NEXT. I THINK
SOME OF THE QUESTIONS THAT ARE
RAISED FROM THIS IS, YOU KNOW,
WHAT IS THE MOST EFFECTIVE AND
ACCURATE WAY TO CATEGORIZE AND
DOCUMENT RACE AND ETHNICITY. DO
PATIENTS WITH PH OF CERTAIN RACE
OR ETHNICITY HAVE CERTAIN
CHARACTERISTICS OF THE DISEASE
COURSE OR ASSOCIATED WITH
WHETHER A PATIENT CAN BE SEEN AT
EXPERT CENTERS VERSUS TREATED IN
THEIR COMMUNITY AND DOES THIS
IMPACT OUTCOME? NEXT.
I THINK ALTHOUGH WE ALL
AGREE WE SHOULD AIM FOR ACCURATE
RACIAL REPRESENTATION IN PH
TRIALS. THE QUESTION IS WHAT IS
THE BEST WAY TO CREATE A
REGISTRY AND BARRIERS FROM
PREVENTING PATIENTS FROM ASIA,
EUROPE AND SOUTH AMERICA. THOUGH
I THINK WE ARE LEFT WITH MORE
QUESTIONS THAN ANSWER, I THINK
THAT IS ONE OF THE BIG POINTS OF
THIS WORKSHOP. I THINK QUESTIONS
THAT WE WILL BE ABLE TO CHIP
AWAY AT OVER THE NEXT TWO DAYS.
I WILL YIELD MY TIME AND HAPPEN
TO OPEN IT UP FOR DISCUSSION,
THANK YOU.
>> THANK YOU VERY MUCH, DR.
GOEL. THAT WAS AN EXCELLENT
TALK. I HAVE A QUICK QUESTION.
WE HAVE ABOUT FIVE MINUTES FOR
QUESTIONS. ONE QUESTION I HAVE
FOR YOU IS, ARE YOU FAMILIAR
WITH ANY RESEARCH INDICATING
THAT HEALTH DISPARITIES SUCH AS
QUALITY OF LIFE IN PH PATIENTS
ARE WORSE THAN OTHER CHRONIC
DISEASES LIKE HEART FAILURE AND
VARIOUS OTHERS, SOMETHING OF
THAT COMPARISON?
>> THAT IS A GOOD QUESTION. YOU
KNOW, I DON'T KNOW WHETHER I
CAME ACROSS SPECIFICALLY
COMPARING IT TO OTHER DISEASES
BUT THERE ARE PLENTY OF STUDIES
WHICH SHOW THAT EVEN PATIENTS,
YOU KNOW, WHO ARE ON, QUOTE,
OPTIMAL THERAPY REGIMENS FOR PH
STILL EXPERIENCE SIGNIFICANTLY
REDUCED QUALITY OF LIFE. AND
HEAVY SYMPTOM BURDEN. I WOULD
NOT BE SURPRISED IF THE QUALITY
OF LIFE IS WORSE FOR PATIENTS
WITH PH THAN, YOU KNOW, OTHER
MORE COMMON DISEASES OR CO.
CO MOR /* /* -- CO MORBIDITIES.
>> THANK YOU FOR THAT EVERYTHING
TALK. I'M IMPRESSED SEEING HOW
YOU HAVE OUTLINED THE INCLUSION
OF UNDERREPRESENTED GROUPS IN
CLINICAL TRIALS AND REALLY HOW
THERE HASN'T BEEN A LOT OF
CHANGE. SO I HAVE TO ASK THE
QUESTION WHICH IS, WHAT DO WE
NEED TO DO DIFFERENTLY? IS THIS
A QUESTION OF THE INVESTIGATORS?
IS THIS A QUESTION OF TRUST
AMONG MINORITY GROUPS OR ARE WE
JUST NOT REACHING THE RIGHT
PEOPLE?
>> YEAH. HONESTLY, I THINK IT IS
A BIT OF THE, D, ALL OF THE
ABOVE SITUATIONS. IF I HAD TO
THINK IT, ONE OF THE BIGGEST
BOTTLENECK S IS GETTING TO AN
EXPERT CENTER, BECAUSE THAT IS
WHERE WE ARE ENROLLING THE
PATIENTS IN THE CLINICAL TRIALS.
THERE ARE A WHOLE HOST OF
PROBLEMS FOR SOMEONE TO JUST GET
TO A CENTER OR A SITE FOR
ENROLLING PATIENTS IN CLINICAL
TRIALS. THE FACT THERE IS A
DIFFERENCE BETWEEN REGISTRIES
AND CLINICAL TRIALS INDICATES
THAT JUST GETTING TO A CENTER IS
NOT ENOUGH. THERE COULD BE A LOT
OF THINGS LIKE WHETHER IT IS
DISTRUST IN MEDICAL SYSTEM. FOR
EXAMPLE HISTORICALLY WITH BLACK
PATIENTS, ENTRUSTING THE MEDICAL
SYSTEM. JUST THE BURDEN OF A
CLINICAL TRIAL AND WHAT THAT
INVOLVES. ALSO THERE COULD BE
IMPLICIT BIASES FROM US
ENROLLING IN THE TRIALS. I THINK
THE NEED TO HAVE AN OBJECTIVE
WAY TO SCREEN PATIENTS AND
ALWAYS PRESENT TRIALS AND NOT
MAKE ASSUMPTIONS. MANY EUROPEAN
TRIALS DO NOT RECOGNIZE RACE OR
ETHNICITY.
>> GOOD POINT. THIS JUST
REQUIRED US TO GO THROUGH EVERY
SINGLE TRIAL AND GO THROUGH ALL
THE APPENDICES AND EXTRA DATA
AND SEE WHETHER THEY REPORTED
BREAK-DOWNS, SO THAT IS HOW THAT
FIGURE WAS GENERATED. I THINK IT
IS ALSO IMPORTANT BECAUSE IT IS
THE IDEA OF WHAT IS PUBLICLY
AVAILABLE, AS OPPOSED TO GOING
THROUGH DIFFERENT LAYERS BEHIND
THE SCENES.
>> A FOLLOW-UP TO THAT IS, WHY
DO YOU THINK EUROPEAN CLINICAL
TRIALS DON'T REPORT ETHNICITY?
>> I ACTUALLY DON'T KNOW. I
THINK IT WOULD BE INTERESTING. I
DON'T KNOW IF THERE ARE RULES
THAT ARE DIFFERENT
COUNTRY-TO-COUNTRY, WHERE THEY
ARE REQUIRED TO OR NOT. THE
BIGGEST THING IS HOW DO WE
ACTUALLY REPORT IT, RIGHT. THE
UNITED STATES MIGHT HAVE A
CERTAIN WAY OF CATEGORIZING WHAT
THEY THINK THE APPROPRIATE RACE
OR ETHNICITIES ARE. OTHER TRIALS
INCLUDED KIND OF GEOGRAPHIC,
LIKE EASTERN EUROPE, WESTERN
EUROPE, SO THERE'S A LOT OF
DIFFERENCES THERE.
>> COULD I MAKE A QUICK GUESS?
>> YES.
>> ONE THING -- I LOOKED INTO
THE SAME THING. ESPECIALLY THE
MORE RECENT TRIALS. WHAT YOU
DON'T REALIZE IS MANY EUROPEAN
TRIALS SEE PATIENTS FROM TWO TO
THREE VERY BIG CENTERS. I WOULD
ASSUME THEY CONSIDER THEMSELVES
PRETTY UNIFORM IN TERMS OF
ETHNICITIES, BASICALLY WHITE
PATIENTS. I THINK ONE, THERE IS
LACK OF INCENTIVE TO REALLY
BREAK IT DOWN. WHEREAS IN REVEAL
YOU HAVE MULTIPLE CENTERS FROM
DIFFERENT PART OF THE UNITED
STATES. SO THAT MAKES IT A
LITTLE MORE APPEALING TO SAY
LET'S BREAK IT DOWN BY RACE.
MANY OF THE BIG PIVOTAL EUROPEAN
TRIALS COME FROM TWO TO THREE
MAJOR CENTERS.
>> REAL QUICK, DR. KAMET.
>> JUST A QUICK COMMENT. THAT
WAS AN AMAZING TALK. YOU REALLY
COVERED SO MUCH. TO THE POINT
HOW DO WE COLLECT RACE AND
ETHNICITY DATA. WE SHOULD BE
USING COMMON DATA ELEMENTS,
SHARED COLLECTION METHODOLOGIES
SO WE CAN HARMONIZE STUDIES AND
KNOW MAKEUP OF STUDIES.
SOMETIMES WE DON'T EVEN DO THAT.
>> FOR THOSE OF YOU DONE STUDY
DESIGN, OF COURSE, THAT SHOULD
BE IN OUR MINDS, I THINK, WHEN
WE ARE DESIGNING STUDIES; IS HOW
TO STANDARDIZE THAT ACROSS
CENTERS, WHICH IS SOMETHING I
THINK WE WILL NEED TO DISCUSS AS
WE MOVE ON. BUT THAT'S BEEN
PARTICULARLY AN ISSUE DOWN HERE
IN ARIZONA AND OTHER CENTERS
INVOLVED IN OUR STUDIES, IS HOW
DO WE DEFINE HISPANIC ETHNICITY.
THAT GETS DOWN TO THE HEART OF
THE DIVERSITY, RIGHT. SO LET'S
MOVE ON. OUR NEXT SPEAKER IS DR.
ESTRADA. HE WILL BE SPEAKING ON
CONVERGENCE OF DISPARITIES AND
PULMONARY VASCULAR PHENOTYPES
AMONG BLACK, AFRICA, NATIVE
AMERICAN, HISPANIC AND M
AND MORE PHENOTYPES, WOW.
>> THANK YOU. I WANT TO THANK
THE CHAIR AND EXCITED TO
CONTRIBUTE AND ACKNOWLEDGE THERE
ARE EXPERTS IN THE FIELD, IN
TODAY'S MEETING WITH US HERE
TODAY. MY OBJECTIVES ARE GOING
TO BE DISCUSSING THE RACIAL AND
ETHNIC DISPARITIES, HOW THEY
INFLUENCE TREATMENT AND
OUTCOMES, MAINLY FOCUSSING ON
PULMONARY HYPERTENSION AND
(AUDIO DISRUPTION) AS DR. GOEL
POINTED OUT THIS LAYS FOUNDATION
FOR FUTURE DISCUSSIONS FOR THIS
WORKSHOP . OUR GOAL IS PROVIDE
EQUAL HEALTH CARE DELIVERY.
DISPARITY MEANS WE HAVE NOT
REACHED THIS GOAL. I THINK TO
UNDERSTAND DISPARITIES WE HAVE
TO FIRST LEARN WHAT GROUPS WE
ARE TALKING ABOUT. SO WHERE DOES
THIS -- SO SORRY. THE NEXT
SLIDE.
WHERE DOES THIS CURRENT RACE
AND ETHNIC CLASSIFICATION COME
FROM? OFFICE OF MANAGEMENT AND
BUDGET IN' 97 ESTABLISHED WHITE,
ASIAN, BLACK, AMERICAN INDIAN,
ALASKAN, NATIVE HAWAIIAN OR
ISLANDER AND HISPANIC OR
NON-HISPANIC. USED FOR
STATISTICAL AND KEN SUS PUR SEN
CENSUS TRIALS BUT WERE REQUIRED
FOR TRIALS.
THE DEFINITION OF DIFFERENT
TERMS ARE ETHNICITY, CULTURAL
IDENTITY. SO LANGUAGE, RELIGION.
RACE IS ANCESTRAL ORIGIN,
PHYSICAL CHARACTERISTICS.
ANCESTRY REFERS TO REGION OF
ORIGIN, OR LINEAGE OF DECENT,
AND GENETIC MIXTURE IS EXCHANGE
FROM PEOPLE FROM DIFFERENT
ANCESTRIES.
I THINK ONE OF THE KEY
CONCEPTS TO MOVE FROM IS, WE
WOULD LIKE IT TO BE LIKE THE
IMAGE ON THE LEFT, THE CRAYONS.
WHEN REALITY IT LOOKS MORE LIKE
THE IMAGE ON THE RIGHT. HOW DO
WE TEASE THIS APART? AS DR. GOEL
POINTED OUT, THESE ARE SOCIAL
CONSTRUCTS THAT DON'T HAVE
BIOLOGICAL MEAN BUT ARE DYNAMIC
AND SHAPED BY POLITICAL AND GEO
FORCES.
IN THIS PAPER IN 21 IT GIVES
GUIDANCE HOW TO REPORT. THEY
SAID REPORTING RACE AND
ETHNICITY SHOULD NOT BE
CONSIDERED IN ISOLATION; USUALLY
SHOULD BE ACCOMPANIED OR
REPORTING OF OTHER SOCIAL
DEMOGRAPHIC OR DETERMINANTS.
THESE TYPICALLY RELY ON
INDIVIDUAL'S PARTICIPATION
SELF-REPORT OR ASSIGNMENT BY
INVESTIGATORS, BUT THEY ARE BOTH
FROM TRULY HIGHLY PRONE TO
ERROR, ESPECIALLY WHEN COMPARED
TO D.N.A.-BASED DETERMINATIONS.
THIS PAPER, THE AUTHOR ASSESSED
SELF-IDENTIFY HISPANICS IN YOUR
CITY, SHOWN TO BE 29 PEREZ
EUROPEAN, 26 PEREZ AFRICAN, 45
PEREZ NATIVE AMERICAN WHEN
ASSESSED BY ANCESTRY AND
MARKERS. HOWEVER THE REPORT
RAISED IN ETHNICITY MEDICAL
RESEARCH DISREGARDS REALITY OF
SOCIAL CERTIFICATION,
INJUSTICES, INEQUITIES FOR
POPULATION HEALTH. TRULY
REMOVING RACE AND ETHNICITY MAY
CONCEAL THESE DISPARITIES. THAT
IS WHY WE ARE HERE TO DISCUSS
ABOUT IT.
HOW HAS OUR POPULATION
CHANGED IN THE UNITED STATES?
COMPARED TO 2010 THE CENSUS IN
2020 HAS DECREASE IN WHITE
POPULATION, INCREASE IN P
HISPANIC POPULATION AND MAPS ON
THE LEFT REFLECT MAJORITY BY
COUNTY. SO THE LARGEST GROUP BY
COUNTY IN THE UPPER IMAGE IS
MOSTLY WHITE ALONE, NON-HISPANIC
ACCEPT IN BORDER TOWNS, WHERE IS
THE MOST MAJORITY, THE HISPANIC.
THE SECOND LARGEST IS HISPANIC
OR LATINO OF ANY RACE. NEXT.
WHEN COMES TO DISPARITIES
THERE IS A BIG SOCIAL COST. THE
COST TO U.S. IS ESTIMATED TO BE
ABOUT $450 BILLION. LOOKS LIKE
IT IS LARGELY DRIVEN BY
DISPARITIES IN AFRICAN-AMERICAN
POPULATION, SPECIFICALLY FOR
EXCESS PREMATURE DEATHS. NEXT.
HOW DOES IT LOOK LIKE IN
PULMONARY HEART DOES CEASE? THIS
REVIEW 2024, BETWEEN 2009 AND
2020 THE AGE INCREASED THROUGH
ABOUT 2026. THEY HAD STEADY
INCREASE UNTIL 2020. ON THE
RIGHT IMAGE THERE SIGNIFICANT
RAC
DISPARITIES ESPECIALLY IN THE
BLACK POPULATION. HOW DOES
OUTCOME FARE IN ETHNICITY. THE
DATABASE USING CODES TO IDENTIFY
INDIVIDUALS WITH PH IDENTIFIED
ABOUT 430,000 DEATHS. DESPITE
ADVANCES IN THERAPY FOR PAH THE
OVERALL MORTALITY INCREASED FROM
8 PER 100,000 TO UP TO 24 BY
100,000. INTERESTINGLY, THOUGH,
USING THIS SAME DATABASE FROM
2003-2020 AND USING THE
MORTALITY RATES, IT APPEARS
DEATHS WERE LARGELY RELATED TO
LEFT-HEARTED LUNG DISEASE, OR
GROUP 2 TO 5. THOSE HAVE BEEN
RISING OVER THE LAST TWO
DECADES, ACCOUNTING FOR THE
MAJORITY OF THIS MORTALITY
BURDEN. THOUGH THERE HAS BEEN A
DECLINE IN GROUP ONE MORTALITY
RATES. AS YOU CAN TELL FROM ALL
COHORTS THE BLACK POPULATION HAS
HAD THE WORST OUTCOMES. NEXT
SLIDE.
WHEN IT COMES TO THE REVEAL
REGISTRY, YOU WILL FIND THE
FIVE-YEAR SURVIVAL ON THE LEFT,
HIGHEST AMONG HISPANIC AMONG
PREVIOUSLY DIAGNOSED PATIENTS.
IN THIS STUDY THEY ANALYZED
OUTCOMES BASED ON ETHNICITY AND
FOUND THOSE IMPROVED SURVIVAL
HISPANIC IN THE UNI-VARIANT
ANALYSIS TBUT WHEN THEY ADJUSTE,
THERE WAS NO DIFFERENCE -- IS
STUDY COULD NOT ACCOUNT IN
SOCIOECONOMIC FACTORS, SINCE
THIS INFORMATION WAS NOT
AVAILABLE ON THE REVEAL
REGISTRY. NEXT.
AS DR. GOEL POINTED OUT,
REPRESENTATION, REGISTRIES AND
FILES IS ONE OF THE KEY ASPECTS
TO BE ADDRESSED. ON LEFT SIDE,
DISCREPANCY BETWEEN WHAT IS
EXPECTED IN CENSUS POPULATION
AND THE REALITY WITHIN THE
REGISTRY, IT IS STARK. ON THE
RIGHT SIDE IT IS A CONDENSED
CHART ABOUT THE TRIALS. MOST HAD
GREATER THAN 75 PEREZ OF WH % /%
OF WHITE POPULATION THEN IN U.S.
54 TO 58 PEREZ. AND NEXT SLIDE,
PLEASE. SO WHEN COMES TO THE
ETIOLOGY ON ETHNICITY, ANALYZING
THE PH BIOBANK, ONGOING FUNDED
SAMPLE OF PATIENTS ENROLLED IN
34 U.S. CENTERS, THIS BIOBANK
HAS CLINICAL DATA AND SAMPLES
AND GENETIC DATA OF ABOUT 1,800,
80 PEREZ ROUGHLY WERE -- 80 % H
THIS SEEMS LIKE THE HISPANIC
COHORTS WERE YOUNGER. IN REVEAL
REGISTRY APPEARS HISPANIC AND
ASIAN WERE YOUNGER. MAJORITY
WITH CONNECTIVE TISSUE DISEASE
WERE MOST AFRICAN-AMERICAN OR
BLACK. NON-HISPANIC OR WHITE
HOUSE HAS FAMILIAR PH RELATED TO
DRUG OR TOXINS. HISPANICS WERE
YOUNGER, HAD HIGHER INCIDENCE OF
CONGENITAL HEART DISEASE
ASSOCIATED. THEY WERE LESS
LIKELY TO BE DESCRIBED PH
MEDICATION AS WELL. IN THE REAL
REGISTRY MOST ASSOCIATED WITH
PULMONARY HYPERTENSION.
>> IN THE MESA CORE STUDY, STUDY
OF AT HER ROW SCLEROSIS, ABOUT
6800, AFRICAN-AMERICAN,
HISPANIC, WHITE AND CHINESE
AMERICAN, THEY ANALYZED THE
INCIDENCE OF CONGESTIVE HEART
FAILURE AND FOUND HIGHER
INCIDENCE OF BLACK AND
AFRICAN-AMERICANS, MOSTLY
RELATED TO HYPERTENSION,
DIABETES AND SOCIOECONOMIC
STATUS. IN 2017 THIS PAPER
ANALYZED RATE OF HEART FAILURE
HOSPITALIZATIONS. IT WAS ABOUT
230 PEREZ HIGHER IN BLACK MEN,
240 PEREZ HIGHER IN BLACK WOMEN
COMPARED TO WHITES IN 2013.
THESE PERSISTED ACROSS THE
DECADE. IN CONTRAST DIFFERENCE
OF HEART FAILURE
HOSPITALIZATIONS NARROWED WITHIN
THE HISPANICS DURING THE SAME
TIME PERIOD. ASIAN AND PACIFIC
ISLANDERS HAVE MAINTAINED THE
LOWEST RATES COMPARED TO OTHER
RACIAL ETHNIC GROUPS. THERE IS
AN INTERESTING STUDY IN
CALIFORNIA THAT SHOW YOUNG BLACK
ADULTS WERE NOT ONLY SIX TIMES
MORE LIKELY TO BE HOSPITALIZED
FOR HEART FAILURE COMPARED TO
WHITE INDIVIDUALS BUT WERE ALSO
YOUNGER AT THE TIME OF
HOSPITALIZATION.
SO SOME KEY POINTS -- NEXT
SLIDE, THANK YOU. SOME KEY
POINTS FOR BLACK POPULATION,
EVIDENCE IN 1986 SHOWED HIGHER
LEVELS IN THE BLACK COHORT.
NOTICE IN 2004 TESTED IMBALANCE
AND QUESTIONED WHETHER IT WAS
RELATED. GABULAR USED SIX RANDOM
TRIALS OF ERA SUBMITTED TO FDA
AND FOUND THERE WAS A BLUNTED
RESPONSE TO TREATMENT TO ERA IN
THE STUDY, THE LONGITUDINAL
PERSPECTIVE OBSERVATIONAL COHORT
OF AFRICAN-AMERICANS, ABOUT 3200
SELF-IDENTIFY AND POTENTIAL BY
ECHO AND FOUND HIGHER LEVEL ONE
WERE ASSOCIATED WITH HIGHER
HYPERTENSION AND HEART FAILURE
AND HIGHER MORTALITY. STUDY IN
2024 USING NATIONAL IN-PATIENT
SAMPLE FROM 2015 E 2019 AND
CODES OF HIV AND PULMONARY
HYPERTENSION, NOTICE OVER
900,000 OF HIV, 3 PEREZ HAS THE
HYPERTENSION. WHEN COMPARED TO
HIV ALONE, THE PH PATIENTS WERE
OLDER, MORE LIKELY TO BE BLACK,
MALE AND HAD A HIGHER INCIDENCE
OF CO. MORBIDITIES. IN 2019
THERE WAS A HIGHER PERCENTAGE OF
BLACK CHILDREN LARGELY DRIVEN BY
LUNG DISEASE WITH PULMONARY
HYPERTENSION. NEXT PLEASE.
SO CONNECTIVE TISSUE DISEASE
PULMONARY HYPERTENSION IN BLACKS
LARGELY RELATED TO INCIDENCE OF
THIS AND LUPUS IN BLACK PP
ALLEGATION ARE HIGHER AND SHOWS
THIS IN AFRICAN-AMERICANS WERE
ASSOCIATED WITH MORE SEVERE PH,
THOUGH MORTALITY ASSOCIATED WITH
SOCIOECONOMIC STATUS, NOT RACE.
THIS STUDY WAS A RETROSPECTIVE
STUDY COMPARING
AFRICAN-AMERICANS TO
NON-AFRICAN-AMERICAN PATIENTS
WITH THIS. THE COHORT ANALYSIS
FROM THE HOPKINS PROGRAM FROM
ABOUT 160 PATIENTS SHOWED BLACK
PATIENTS WITHER FOUND TO HAVE
WORST FUNCTIONAL CLASS UPON
PRESENTATION, LOWER EXERCISE,
HIGHER NATURAL PEPTIDES, MORE
SEVERE HUMAN DYNAMIC METHODS AND
TRANSITORY TOWARDS SURVIVAL.
NEXT SLIDE.
DO BLACKS HAVE WORSE
OUTCOMES IN PH? THIS IS VERY
INTERESTING STUDY FROM THE
VANDERBILT GROUP ASSESSING THE
CATH IN IN-PATIENT AND
OUTPATIENT SETTINGS FROM
2008-2014. ABOUT 4,500 PATIENTER
WERE INCLUDED, OF THE ONES 13 %
ANAPHYLACTIC. THEY W AFZ /* --
AFRICAN-AMERICAN AND HAD HIGHER
PREVALENCE OF ALL ETIOLOGIES OF
HYPERTENSION, 41 HIGHER RISK OF
PH AND 24 PERCENT ADJUST RISK TO
MORTALITY. THIS OTHER STUDY IN
2017 WAS MENTIONED ALREADY.
INCLUDED 250PH PATIENTS
ANALYZING TWO COHORTS. THEY ONLY
USED BLACK AND WHITE RACE,
OTHERS WERE EXCLUDED. IF THEY
HAD -- WERE OUT OF THIS TWO
COHORTS. AFTER ADJUSTMENT FOR
AGE AND FUNCTION OF CLASS,
BLACKS HAD HIGHER, GREATER
MORTALITY RISK BUT DISAPPEARED
WHEN ADJUSTED FOR INSURANCE
STATUS. THIS PAPER IS GOING TO
BE QUOTED LATER ON AS WELL. PH
IS MORE PREVALENCE IN BLACKS
WITH SARCODOSIS IN REGISTRY AND
12% HIGHER THAN IN CAUCASIANS
AND IN THIS OBSERVATIONAL
REGISTRY IN THE U.S.
INITIATE ED IN 2011, ABOUT 200
PATIENTS WERE DIAGNOSED WITH
THIS, 55% WERE OF BLACK RACE IN
THE SARCODOSIS COHORT. WHEN
COMES TO HUMAN DYNAMICS BLACK
HAVE HIGHER MPAP PRESSURES AND
THIS STUDY, THE CORONARY RISK
DEVELOPMENT IN YOUNG ADULT.
BETWEEN 1985, OVER 5,000
PATIENTS WERE ENROLLED, USUALLY
BLACK OR WHITE. 18 TO 30 YEARS
OLD THEY WERE ENROLLED IN FOUR
SITES. IN 2017 THIS STUDY FOUND
THE ASSOCIATION BETWEEN BLACK
AND HIGHER PULMONARY PRESSURES
IN ECHO, IT WAS REGARDLESS OF
AGE. ON THE RIGHT SIDE WE SEE
THE JACKSON HEART STUDY, THE
LONGITUDINAL POPULATION BASED
COHORT, AND THIS FOR PATIENTS
RESIDING IN JACKSON,
MISSISSIPPI, FOUND HIGH
ARTERIAL PRESSURE WAS
SIGNIFICANT RISK FACTOR FOR
HOSPITALIZATION. NEXT SLIDE,
PLEASE.
>> THIS IS WHEN WE TALK ABOUT
AMERICAN INDIAN AND ALASKAN
NATIVE WITH CARDIOVASCULAR
DISEASE, THERE WAS A SCARCITY.
THIS IS ONE OF THE PAPERS FROM
GEMA. 50% HAS CARDIOVASCULAR
DISEASE AND USING THIS COHORT
NOTICE THERE IS DECREASE IN CD,
INCREASE IN MI AND HEART
FAILURE. RATE OF CVA AND AFIB
STAYED THE SAME. INTERESTING,
20% MORTALITY RATE WITHIN THIS
COHORT. NEXT SLIDE. IN THE
KOREAN STUDY PATIENTS, ABOUT 1.9
PER YEAR PER MILLION. THE
SURVIVAL WAS ABOUT 90%. FOR
COMPARISON I PUT REVEAL OF
REGISTRY 1 SURVIVAL ABOUT 90% AS
WELL. THIS KOREAN CORE RECEIVED
LESS INTENSIVE THERAPY THOUGHT
DUE TO INSURANCE. IN JAPAN, MORE
PREVALENT, ABOUT TWO-THIRDS. BUT
THREE-YEAR, PRE-SURVIVAL RATE
WAS ABOUT SAME IN REVEAL
REGISTRY, AROUND 70s. IN INDIAN
CONGENITAL HEART DISEASE WAS
MOST PREVALENT AND MORTALITY 8%
IN PERIOD BETWEEN 2015 AND 2023.
IN PHILIPPINES, THIS WAS MOSTLY
ASSOCIATED WITH LUPUS. HIGHEST
MORTALITY WITH SCLERODERMA.
WHEN COMES TO ASIAN OUTCOMES
THESE REGISTRIES ARE
INTERESTING. ONE ON LEFT IS
SINGAPORE WITH MULTI -ETHNIC
ASIAN COHORT FROM 2003-2016.
THESE ARE BETTER WHEN COMPARED
TO FRENCH AND KOREAN. MOST
COMMON CON GENERATIVE HEART
DISEASE, IDIOPATHIC AND
CONNECTIVE TISSUE DISEASE,
MAJORITY CLASS 2, 50% FUNCTIONAL
AND MOST WERE ON MONOTHERAPY.
54%. THE ETHNICITY WERE A MIX OF
CHINESE, MALAI AND OTHERS. I
THOUGHT IT INTERESTING TO SEE
WHAT OTHER PARTS OF THE WORLD
ARE DOING WELL, SAME CHALLENGES
THEY ARE FACING. IN THIS CHINESE
REGISTRY FROM 199 9 TO 2004
TLUZ WITH A DELAY AND WORSE THAN
REGISTRIES. AT THE TIME THEY
DIDN'T HAVE (?) IN THAT REGION.
NEXT SLIDE.
WHAT DO WE DO ABOUT HISPANIC
SURVIVAL AND HISPANIC COHORT?
THE EVENT DISAPPEARED SOCIAL
WROTE ECONOMIC STATUS ADJUSTMENT
IN THIS PAPER BY BERNARDO,
QUOTED LATER ON, HAD A HIGHER
REPRESENTATION OF MINORITIES
FROM THE FAR REGISTRY COMPARED
TO THE OTHER SHEET. HISPANIC
PATIENTS WERE MOST COMMON
ASSOCIATED TO DRUG OR CONGENITAL
HEART DISEASE. THERE WAS A HIGH
IMPAIRED ACCESS TO HEALTH, LOWER
ANNUAL INCOME, LOWER EDUCATIONAL
LEVEL, HIGHER UNEMPLOYMENT,
HIGHER FREQUENCY OF EMERGENCY
VISITS AND HIGHER
HOSPITALIZATIONS DESPITE SIMILAR
FUNCTIONAL CLASS, RISK, EXERCISE
CAPACITY AND SPECIFIC THERAPY.
THIS SURVIVAL ANALYSIS WAS NO
LONGER PRESENT AFTER ADJUSTMENT
FOR AGE, SEX, PH SUB TYPE AND
SOCIAL DETERMINANTS OF HEALTH.
SOME LIMITATIONS IS IT IS A
SMALLER DATA SET THAN THE
REVEAL. THIS FROM PATIENTS
REFERRED TO PH, WHICH I THINK IS
GOING TO BE A PROBLEM WE WILL BE
TALKING ABOUT OVER AND OVER
AGAIN. NEXT SLIDE. HOW DO
HISPANICS DO IN GENERAL? THEY
HAVE A BETTER PROFILE. ON THE
LEFT YOU WILL FIND TWO PAPERS
THAT SHOW THAT A RETROSPECTIVE
ANALYSIS WITH CATEGORY IZATION
OF COHORT OVER TEN YEARS, ABOUT
200 PATIENTS AND 61% WERE
HISPANIC. HISPANIC PATIENTS HAD
LOWER PRESSURES, LOWER PDR AND
HIGHER CARE COMPLIANCE AND TREND
OF BETTER SURVIVAL ALSO BASED ON
THE LEVELS. THE RIGHT SIDE, A
PAPER BY DR. WOODS' GROUP AND
NOTICED DIFFERENCES BASED ON
CARDIAC MRI FROM THE STUDY. THEY
HAD COMPARED TO WHITES, HISPANIC
HAD GREATER AND LARGER DIASTOLIC
VOLUME AND MASS, BLACKS HAD
LOWER RV MASS WHEN ADJUSTING TO
CO. VARIANTS INCLUDING LP MASS
AND HISPANIC HAD HIGHER COMPARED
TO WHITES. QUESTION REMAINS
WHERE THESE ARE DIFFERENCES
REFLECT ADAPTIVE OR MALADAPTIVE
MODELLING BUT DATA SUGGEST THIS
ARE KNOWN TO HAVE PROGNOSTIC
SIGNIFICANCE INCLUDING RV MASS.
NEXT SLIDE. SO HISPANICS HAVE
IMPROVED SURVIVAL DESPITE WORSE
HEMODYNAMICS, BUT THE DOCTOR,
WHO IS WITH US. COLLECTED DATA
FROM FOUR COHORTS AND COMPARE
HISPANIC, WHITE, BLACKS. THEY
DID IT BETWEEN IDIOPATHIC AND
HEREDITARY PH. ETHNICITY WAS
SELF-REPORTED BY INDIVIDUALS.
THOSE GENOMIC DATA GATHERED TO
DETERMINE THEIR ANCESTRY.
HISPANICS HAD SURVIVAL BENEFIT
AFTER ADJUSTING FOR AGE, SEX AND
PDR. ALSO (?) USE LOWEST AMONG
THE GROUP WITH HIGHEST AND
LOWEST PRESSURES, THE SLIDE I
MENTIONED. AFRICAN-AMERICAN HAD
LOWEST AVERAGES AND LOWEST
AVERAGE WALK DISTANCE. IN IMAGE
ON THE RIGHT THE GRAPH REFLECTS
COMBINED ESTIMATE OF PERCENTAGE
OF AFRICAN, EUROPEAN AND DAY AND
INDICATED SELF-REPORTED RACE AND
ETHNICITY. WHEN TWO CORES WERE
OVER LAID FOR MAGNITUDE IT WAS
NOTICED TO BE HIGHER FOR
NATIVE-AMERICAN AND LOWER FOR
AFRICAN ANCESTRY. NEXT SLIDE.
WHAT HAPPENS TO HISPANIC IN
LATIN AMERICA BUT NOT UNITED
STATES. REGISTRY SHOWS THEY ARE
DIAGNOSED AT YOUNGER AGE, AROUND
34. MORE FEMALE THAN MALE. MORE
ADVANCED STAGES OF PH, PROBABLY
DUE TO LIMITED ACCESS TO HEALTH
FACILITY AND DIAGNOSTIC.
COMPARED TO REVEAL IN FRENCH
REGISTRIES, THEY ARE SIMILAR. IN
BRAZIL N ADDITION OF (?) AND
REGIONAL OUTCOMES ARE SIMILAR TO
OTHER WELL-KNOWN REGISTRIES. I
WANT TO POINT OUT (AUDIO
DISRUPTION) AND IN THE LAST
MINUTE I WANT TO SHOW YOU WHY I
BECAME INTERESTED. I DID NOT
RESEARCH THIS BUT BORN IN
GUATEMALA IT APPEARED MEDICAL
RESEARCH WAS MISSING GRANULARITY
OF HOW HETEROGENEOUS THIS IS. I
WANTED TO INQUIRE FURTHER. NEXT
SLIDE. THE HISPANIC PARADOX THAT
TALKS ABOUT LONGER HISPANIC
SURVIVAL DESPITE WORSENING
CARDIOVASCULAR RISK FACTORS. I
FOUND THIS STUDY AT OUR CENTER?
SAN ANTONIO THAT TESTED THIS,
LONGITUDINAL STUDY. THEY ASKED
THE QUESTION, ARE ETHNIC
DIFFERENCES IN MORTALITY
CONSISTENT WITHIN HISPANIC
PARADOX. MEXICAN-AMERICAN VERSUS
EUROPEAN-AMERICAN COHORTS. NEXT
SLIDE. VERY IMPORTANTLY,
CLASSIFICATION BY ETHNIC GROUP
WAS INVALIDATED STANDARDIZED
FORM THEY USED PARENTAL
SURNAMES, BACKGROUNDS OF
GRANDPARENTS AND CONCLUDED TO
THE HISPANIC PARADOX HISPANIC
WERE AT GREATER RISK OF
MORTALITY. SOCIOECONOMIC STATUS
DIFFERENCES LARGELY EXPLAINED
THIS DISPARITY. WHEN ADJUSTED
FOR THE ANALYSIS, CO MORBIDITY
AND SYSTEMS WERE MORE PREDICTIVE
IN MORTALITIES. NEXT SLIDE.
WITHIN HISPANIC PARADOX, I
THINK WE HAVE A PARADOX. MANY
STUDIES THAT SUPPORTED HISPANIC
PARADOX ARE BASED ON DATA FROM
NATIONAL AND STATE VITAL
STATISTICS AND NATIONAL HEALTH
SERVICE, SO WHY DO WE HAVE THIS
PARADOX? I THINK IT WOULD BE A
MISCLASSIFICATION IN DEATH
RECORDS, HEALTH IN MIGRANT
EFFECT, JUST THE PEOPLE HEALTHY
ENOUGH TO TRAVEL COME TO THE
STATES, COULD BE THE SALMON BIAS
THAT TALKS ABOUT WHEN PATIENT
GETS SICK ENOUGH THEY WOULD
RATHER NOT DIE IN STATES SO GO
BACK TO THEIR ORIGIN COUNTRY, SO
WE ARE MISS ING THAT DEATH
RECORD OR SOCIAL-CULTURAL FACTS
RELATIVE TO HISPANIC. NEXT
SLIDES.
KEY QUESTIONS WILL BE HOW DO
WE CLASSIFY THESE GROUPS? HOW DO
WE NEED TO ADJUST AND ADAPT
REGISTRY, TRUE DISTINCTIONS
BETWEEN BIOLOGICAL AND SOCIAL
DETERMINANTS AND CONCENTRATE
OMIC PATTERNS WITHIN THIS? NEXT
SLIDE. P
THIS IS HOW WE UNPACK THIS.
TALK ABOUT THE COUNTRIES OF
BIR
BIRTH, CITIZEN STATUS, LANGUAGE
SPOKEN, SURVEY AND THIS IS FROM
RESEARCH AND EVALUATION FROM
WASHINGTON, TRYING TO UNPACK HOW
WE UNDERSTAND THESE COHORTS
BETTER. SO DR. HYDE WILL TALK
ABOUT THE NEXT INTERVENTIONS TO
ADDRESS DISPARITIES. WANT TO
LEAVE YOU WITH THIS LAST
THOUGHT. SO OUR GOAL SHOULD BE
TO PROVIDE A PRECISE FRAMEWORK
FOR CLASSIFYING RACE AND
ETHNICITY IN PULMONARY VASCULAR
RESEARCH THAT CAPTURES GENETIC
INFORMATION AND SOCIAL
DETERMINANTS TO ADDRESS THIS. I
WENT OVER THE TIME BUT
APPRECIATE THE TIME TO SPEND
WITH Y'ALL AND OPEN FOR
QUESTIONS AND DISCUSSIONS.
THANKS SO MUCH.
>> THANK YOU, DR. ESTRADA. THAT
WAS AN INCREDIBLE SUMMARY OF THE
DISPARITIES IN THE DIFFERENT
GROUPS. IT REALLY HIGHLIGHTS, I
THINK, SOME OF THE ISSUES THAT
WERE BROUGHT UP BY DR. KAY AND
MYSELF WITH REGARD TO
CLASSIFICATION. WE DON'T HAVE A
LOT OF TIME FOR QUESTIONS RIGHT
NOW, JUST A COUPLE MINUTES. WHAT
I'M GOING TO DO IS MOVE ON TO
THE NEXT TALK. THEN WE WILL HAVE
20 MINUTES TO DISCUSS SOME OF
THE QUESTIONS. I'M SURE THERE
ARE LOTS OF QUESTIONS THAT ARE
STARTING TO POP UP. SO WITH THAT
LET'S MOVE ON TO INTERVENTIONS
WITH RACE, ETHNICITY AND
IMPLEMENTATION BY DR. SAHAY.
>> THANKS, EVERYONE. THANKS
ORGANIZERS FOR INVITING ME HERE
TO DISCUSS THIS INTERESTING
TOPIC. SOME OF THE THINGS ARE
DISCUSSED BY THE PREVIOUS TWO
SPEAKERS. I WILL TRY TO GO
QUICKLY FROM THEM BUT HIGHLIGHT
AREAS WE CAN WORK ON TOGETHER TO
IMPROVE REPRESENTATION OF
RESEARCH AND IMPROVE CARE OF THE
PATIENTS. NEXT SLIDE.
THESE ARE MY DISCLOSURES.
NEXT SLIDE. LET'S FIRST CLARIFY
SOME OF THE TERMINOLOGY WE ARE
DISCUSSING SINCE MORNING IN
DIFFERENT TALKS. NEXT SLIDE.
SO WHAT ARE WE REALLY
UNDERSTAND BY RACE, ETHNICITY
AND DISPARITIES AND SOCIAL
DETERMINANTS OF HEALTH? I WILL
GO ONE-BY-ONE ON EACH OF THESE.
NEXT SLIDE.
SO THE FIRST DESCRIPTION OF
RACE ACTUALLY STARTED IN AROUND
THE 15TH CENTURY, BUT FORMALLY
DOCUMENTED BY THE SWEDISH
TOKSTOK
TAXONOMIST. EUROPEANS ARE FAIR,
GENTLE, ACUTE. AMERICANS
COPPER-COLORED, OBSTINATE.
ASIAN, SOOTY, SEVERE, HAUGHTY...
IT IS WHAT DIFFERENCE RACES
MEANS HERE AND LET'S GO TO THE
NEXT SLIDE. THIS IS PART OF THE
DISCUSSED BY JOHANN BLUMENBACH,
AROUND 17TH AND 18TH CENTURY,
DEFINED IT MORTGAGEE GRAPHI--
GEOGRAPHICALLY AND HE WAS THE
FIRST TO USE THE TERM CAUCASIAN,
DESCRIBED THEM AS BEAUTIFUL
PEOPLE. REST DEPENDING WHERE THE
REGION THEY BELONGED TO. NEXT
SLIDE. TECHNICALLY, THERE IS NOT
REALLY A LOT OF EVIDENCE AND
DATA THAT THE RACE IS
GENETICALLY DIVERSE. RACES IN
21ST CENTURY ARE A
SOCIO-POLITICAL CONSTRUCT AND
DOES NOT HAVE A SCIENTIFIC OR
BIOLOGICAL BASIS. WHAT IS AN
ETHNICITY, IT IS A CONCEPT TO
IDENTIFY INDIVIDUAL PEOPLE OR
POPULATION, REFERENCE TO
LANGUAGE, ATTRIBUTES OR
RELIGION. RACE AND ETHNICITY MAY
OVERLAP BUT ON THE PHENOTYPE
RELATED TO ETHNICITY. LIKE RACE
IT IS A SOCIAL CONSTRUCT WITH NO
BIOLOGICAL BASIS. NEXT SLIDE.
WHEN WE TALK ABOUT
DISPARITIES WHAT DO WE
UNDERSTAND? THIS IS FROM THE NIH
BACK IN 2014. HEALTH DISPARITIES
ARE DIFFERENCES THAT EXIST AMONG
SPECIFIC POPULATION IN
ATTAINMENT OF FULL HEALTH
POTENTIAL THAT CAN BE MEASURED
BY DIFFERENCES IN INCIDENCE,
PREF LANCE, MORTALITY, BURDEN OF
DISEASE AND OTHER ADVERSE HEALTH
CONDITIONS. WHILE THE TERM OFTEN
USED OR INTERPRETED TO REFLECT
DIFFERENCES BETWEEN RACIAL OR
ETHNIC GROUPS, DISPARITIES CAN
EXIST ACROSS MANY OTHER
DIMENSIONS SUCH AS GENDER,
SEXUAL ORIENTATION, AGE,
DISABILITY STATUS, SOCIOECONOMIC
AND GEOGRAPHIC LOCATION. WE WILL
TOUCH ON SOME DURING THESE
TWO-DAYS WORKSHOP. NEXT SLIDE.
WHAT IS SOCIAL DETERMINANTS
OF HEALTH? ACCORDING TO THE WHO
ARE DEFINED AS CIRCUMSTANCES IN
WHICH HUMANS ARE BORN, DEVELOP,
LIVE, EARN AND AGE. IN THE
INTERNATIONAL REGIONAL, STATE OR
LOCAL LEVEL, THE DISTRIBUTION OF
MONEY, POWER AND RESOURCES SHAPE
THESE CIRCUMSTANCES. NEXT SLIDE.
WHAT DO WE KNOW ABOUT HEALTH
DISPARITIES RELATED TO RACE,
ETHNICITY IN PAH? ACTUALLY, NOT
ENOUGH. NEXT. I THINK DR. GOEL
AND DR. ESTRADA COVERED A LITTLE
BIT. I'M NOT GOING SPEND TOO
MUCH TIME .
THE MESSAGE IS CLEAR THAT
DIFFERENT HISTORIES AND
DIFFERENT TRIALS OVER THE YEARS
ARE OVER-REPRESENTED BY THE WIDE
POPULATION .
THE REAL PH, THE SCIENTIFIC
REGISTRY, FAR REGISTRY AND
DIFFERENT TRIALS ARE
PREDOMINANTLY OVER-REPRESENTED
BY THE WHITE POPULATION,
INDICATED BY THE BLUE BARS IN
THESE FIGURES. NEXT SLIDE.
AGAIN, THE MESSAGE CONTINUES
SINCE THE FIRST INITIAL ORAL
THERAPY (?) PREDOMINANTLY WHITE
AND THESE ARE PREDOMINANTLY
WHITE. NEXT SLIDE.
NOTHING HAS REALLY CHANGED
OVER THE LAST TWO DECADES. THAT
IS SOMETHING WHAT WE SHOULD BE
DISCUSSING TODAY, WHY THESE
CLINICAL TRIALS HAVE REMAINED
THE SAME, WERE ENROLLING EVEN IN
2024, STARTING BACK IN 2000.
NEXT SLIDE.
THIS STORY IS NOT RELATED TO
PH BUT IF YOU LOOK, THIS IS THE
DATA FROM THE FDA IN 2020. THIS
IS DATA FROM ALL THE TRIAL DATA
WHICH WAS PRESENTED TO FDA IN
2020. YOU WILL SEE THAT 75% OF
PATIENTS WERE WHITE. SO THIS
ISSUE IS NOT RELATED TO THE PH
CLINICAL TRIALS BUT IN GENERAL
RELATED TO THE WAY WE CONDUCT
OUR RESEARCH, AT LEAST IN THE
UNITED STATES. NEXT SLIDE. IF
YOU FOCUS ON THE PULMONARY
HYPERTENSION, THE OLDER DATA,
FROM' 79 TO' 96 WHEN TERM FOR
HYPERTENSION WAS USED. AGAIN THE
AFRICAN-AMERICAN BLACK PEOPLE
HAD HIGHER MORTALITY IN 1980 TO
2002 DATA, SHOWING THAT PRIMARY
AND SECONDARY PULMONARY
HYPERTENSION, HIGHER MORTALITY
IN AFRICAN-AMERICAN POPULATION.
I'M NOT GOING INTO DETAIL
BECAUSE DR. ESTRADA WENT INTO
QUITE BIT OF DETAIL DISCUSSING
THESE TOPICS. GO AHEAD, NEXT
SLIDE.
AGAIN, IF WE LOOK AT MORE
CONTEMPORARY DATA, AGAIN IT IS
SHOWING THAT NON-HISPANIC BLACK
PATIENT, THIS IS THE U.S.
EPIDEMIOLOGICAL DATA AGAIN
SHOWING THE HIGHER MORTALITY IN
NON-HISPANIC BLACK PATIENT
POPULATION. THIS IS AGNOSTIC TO
PH; THIS IS TALKING GENERAL
DISEASE AND MORTALITY DATA IN
THE UNITED STATES. NEXT SLIDE.
SO WE TRY TO ASSESS THIS IN
THE REVEAL REGISTRY AND
PUBLISHED THIS PAPER A FEW YEARS
AGO, WHERE WE WANTED TO ASSESS
THE IMPACT OF RACE ON THE
SURVIVAL IN PH. WE DID NOT FIND
ANY SIGNIFICANT DIFFERENCE IN
THE SURVIVAL WHEN ADJUSTED FOR
AGE, SUBTYPE AND TIME FOR
DIAGNOSIS. I THINK ROBERTO'S
PAPER DID NOT FIND SIGNIFICANT
DIFFERENCE IN HISPANIC MORTALITY
VERSUS OTHERS AFTER THE
ADJUSTING FOR VARIABLES. NEXT
SLIDE.
HOWEVER, THERE WERE CERTAIN
OBSERVATIONS IN THIS ANALYSIS
THAT THE ERAs WERE LOWER USED IN
HISPANIC PATIENTS. NOT EXACTLY
CLEAR WHY. ONE OF THE
ASSUMPTIONS WAS BECAUSE THEY HAD
MORE HYPERTENSION, PERHAPS ERA
WAS LESS USED, AFRICAN-AMERICAN
PEOPLE HAD LESS USE OF
PHOSPHOROUS DIESTERASE INHIBITOR
AND LESS USED IN THIS ANALYSIS.
NEXT SLIDE.
THIS IS ANOTHER
SINGLE-CENTER STUDY, MAINLY
FOCUSED ON IDIOPATHIC AND
ANOREXIG E /* EN PATIENTS. MORE
CONFLICTS WITH THIS RESEARCH,
THE MORE YOU WILL FIND. THAT
SHOULD BE THOUGHT-PROVOKING SO
CLEARLY HERE THE
AFRICAN-AMERICAN AND
ASIAN-AMERICAN SHOWED HIGHER
MORTALITY. NEXT SLIDE.
THIS IS FROM THE PHAR
REGISTRY, I THINK FROM ROBERTO'S
PAPER. FOCUSSING ON THE HISPANIC
POPULATION COMPARED TO THE
ACCESS TO HEALTH CARE, LOWER
EDUCATION LEVEL, INCOME. THIS IS
DESPITE HAVING SIMILAR DISEASE
SIMILARITY. NEXT SLIDE. BUT AS I
MENTIONED EARLIER THE ADJUSTED
MORTALITY ANALYSIS DID NOT FIND
DIFFERENCE IN THE HISPANIC
POPULATION. NEXT SLIDE.
THIS WAS A NICELY DONE STUDY
FROM CHINA WHERE THEY ACTUALLY
WANTED TO ASSESS THE IMPACT OF
THE SOCIOECONOMIC STATUS. AS YOU
CAN SEE IN THESE FIGURES, A
WHERE THEY ADJUSTED IT FOR THE
AGE, SEX, B IS AGE, SEX,
FUNCTION, CLASS AND PVR THEN
AGE, SEX, FUNCTION CLASS, PVR
AND THE PDE5A AND AFFECTED THE
SURVIVAL IN THE CENTER IN CHINA.
PUBLISHED IN A JOURNAL. I THINK
THIS IS ONE OF THE ONLY STUDY I
I COULD FIND WHERE SOCIOECONOMIC
STATUS IMPLICATING SURVIVAL OF
PAH. NEXT SLIDE.
NOW WHAT IS THE REASON THAT
WHY WE ARE SEEING THESE ISSUES
THAT WE ARE NOT ABLE TO SEE MUCH
OF THE PRESENTATION OF THER
RACES IN THE CLINICAL TRIALS?
I'M GOING TO -- IN THE NEXT FEW
SLIDES I'M GOING TO TALK SOME OF
THESE AREAS AND SOME OF THESE
POINTS WILL BE PROVOCATIVE TO
THINK AND THE REALITY OF OUR
LIVES. THERE MAY BE A PERCEIVED
PERSONAL RISK OR FEAR, TRUST IN
MEDICAL COMMUNITY, ETHNIC OR
CULTURAL BACKGROUND OR DIVERSITY
IN HEALTH CARE. I'M SURE
EVERYONE WHO IS PRESENT HERE IS
FAMILIAR ABOUT THE TUSKEGEE
STUDY, WHERE THE 100
AFRICAN-AMERICAN PEOPLE, MALES
ACTUALLY, DIED DURING THE PERIOD
OF THIS STUDY. AS YOU MAY KNOW
PENICILLIN WAS APPROVED IN 1947
BUT THEY WERE INJECTED WITH THE
SYPHILIS AND -- THE ORGANISM,
NOT TREATED AND OBSERVED FOR THE
NATURAL PROGRESSION OF THE
DISEASE. THE STUDY ACTUALLY
CONTINUED UNTIL 1972. CLEARLY
STUDIES LIKE THIS LEADS TO THE
MISTRUST IN HEALTH CARE IN
GENERAL AND CLINICAL RESEARCH.
NEXT SLIDE.
I WOULD ALSO WANT TO
HIGHLIGHT THIS STUDY, FROM JOHNS
HOPKINS. HENRY HENRIETTA LACKS,
WHERE THE BIO COMPANIES
BENEFITTED, NEVER GAVE CONSENT,
DIED AT 31, FAMILY NEVER
COMPENSATED. IN 2020 FINALLY
JOHNS HOPKINS HAD SORT OF LIKE A
DEAL OR CONTRACT WITH HER FAMILY
MEMBERS, CAME UP -- AND NIH WAS
INVOLVED TO APPROVE THE RESULTS
OF WHATEVER RESEARCH THEY HAD
CONDUCTED OVER THE YEARS. SO
THESE ARE THE STORIES WHICH ARE
REAL LIFE AND NOT REALLY OLD.
THIS CENTURY, THE LAST FEW
YEARS. MANY OF US WERE PROBABLY
BORN WHEN THESE STUDIES WERE
ONGOING, SO THEY DEFINITELY LEAD
TO LACK OF TRUST IN THE HEALTH
CARE SYSTEM. NEXT SLIDE.
THIS IS SOMETHING I WANT TO
SHOW CONTEMPORARY, CURRENTLY
WHAT WE ARE DOING IN THIS
EXAMINATION SURVEY. I WANT TO
SHOW YOU THE GRAY BOX. I DON'T
KNOW IF YOU CAN SEE MY CURSOR,
BUT THE NON-HISPANIC BLACK HAVE
SIGNIFICANTLY HIGHER OBESITY,
MALES AND FEMALES, 49 FOR MALES,
56
56.9 IN BLACK WOMEN. WHEN WE ARE
DESIGNING OUR CLINICAL TRIAL
PROTOCOLS, HOW ARE WE USING OUR
INCLUSION CRITERIA WITH
SYSTEMATICALLY EXCLUDE THESE
PATIENTS. NEXT SLIDE
THIS IS ONE OF THE EXAMPLES
I WANT TO PUT IT THERE. THE
SERAPHIN STUDY USED A BMI CUT OF
30. THIS IS THE U.S. DATA WHERE
THE OBESITY IS DEFINED BMI30. IF
YOU PUT 30 AUTOMATICALLY YOU ARE
EXCLUDING THE BLACK PATIENT
POPULATION. THAT IS ONE OF THE
REASON YOU ARE NOT ABLE TO SEE
THESE PATIENTS IN YOUR CLINICAL
TRIALS. I'M NOT SAY ING THIS IS
THE ONLY REASON BUT
COMORBIDITIES IS A BIG FACTOR. I
WANT TO HIGHLIGHT THE
COMORBIDITY, THE PREF LANCE OF
-- THIS IS FROM CDC. THE
PREVALANCE IS HIGHER IN BLACK
SIGNIFICANTLY THAN WHITE. SO IF
YOU HAVE LESS THAN 70, THIS IS
FROM OUR DATA THAT 33% WERE
INELIGIBLE BECAUSE OF THE (?)
LESS THAN 70. POINT I'M TRYING
TO HIGHLIGHT, IF WE ARE GOING TO
HAVE SUCH INCLUSION OF
EXCLUSIONARY CRITERIA WE ARE
AUTOMATICALLY GOING DISQUALIFY
BLACK POPULATION. SIMILARLY IN
THE GRIFFIN, SERAPHIN AND
CUT-OFF 85% WILL AUTOMATICALLY
EXCLUDE BLACK POPULATION. THIS
IS FROM MY CENTER DATA, AROUND
350 PATIENTS, WHEN APPLIED
INCLUSION-EXCLUSION CRITERIA ON
THE REAL WORLD PH POPULATION WE
EXTRUDED THESE. I HAVE NOT GONE
IN BUT QUITE CONFIDENT WE WILL
FIND SIMILAR RESULTS. THIS IS AN
ONGOING ANALYSIS. NEXT SLIDE.
SO WHAT ARE THE OTHER
FACTORS OF LACK OF HEALTH,
EDUCATION AND KNOWLEDGE OF
CLINICAL TRIALS, TIME
COMMITMENT, COST OF
PARTICIPATION, EDUCATION LEVEL,
SOCIOECONOMIC STATUS AND
INSTITUTIONAL BARRIERS? I WILL
DISCUSS THOSE IN A MINUTE ABOUT
THE INSTITUTIONAL BARRIER
BECAUSE THAT IS SOMETHING WHICH
I EXPERIENCED AT MY INSTITUTE
AND HAVE TRIED TO HELP TO SOME
EXTENT BUT NOT COMPLETELY. NEXT
SLIDE. PRSO WHAT GUIDING THIS?
CERTAIN BIOLOGICAL DIFFERENCES
WHICH MAY CONTRIBUTE,
INFLUENCING TO THE TREATMENT. I
THINK DR. ESTRADA AND GOEL
HIGHLIGHTED THE (?) OVER
EXPRESSED IN AFRICAN-AMERICAN
POPULATION BUT BLUNTED RESPONSE
WITH THE ER, I THINK THOSE COULD
BE VARIATIONS WHICH WE THINK
RACE AND ETHNICITY ARE COMPLEX
AND SOCIAL CONSTRUCT AND OVERLAP
VERIAL WITH DONE WHICH CLEARLY
SHOWS IMPACT OF SOCIAL OWE
IMPACT. SOME ARE SHOWN TO LIVE
IN DEPRIVED COMMUNITIES AND DR.
(?) STUDY SHOWED THE PATIENT WHO
LIVED FAR FROM THE EXPERT CARE
CENTER SO IMPACTS THEIR ACCESS
AND HEALTH CARE AND DIFFERENCES
IN OUTCOME MAY NOT ONLY REFLECT
BIOLOGICAL SYSTEMS BUT SHAPED BY
SYSTEM INEQUITIES IN THE THEIR
ACCESS TO HEALTH CARE. I THINK
WE HAVE COVERED ALL THIS
MORNING. NEXT SLIDE.
THIS IS ONE SLIDE. I THINK
DR. ESTRADA PRESENTED EARLIER.
JUST WANT TO HIGHLIGHT, IF YOU
FOCUS ON RED AND ORANGE LINES
HERE, THEY PRESENT THE BLACK AND
HISPANIC PATIENT POPULATION AND
JUST SHOWING THE U.S. CENSUS
DATA, WHICH CLEARLY SHOWS THAT
THE PER-CAPITA INCOME OF THE
BLACK AND HISPANIC PATIENT
POPULATION IS MUCH LESS THAN THE
OTHER RACES IN THE UNITED
STATES. NEXT SLIDE.
SO WHAT ARE THE
INTERVENTIONS? WHAT CAN WE DO?
THERE COULD BE SOME
DISEASE-AGNOSTIC INTERVENTION
WHICH COULD BE WIDESPREAD INTO
HEALTH CARE AND DISEASE-SPECIFIC
WHICH ARE RELATED TO PULMONARY
DISEASES. I WILL PROVIDE A
LITTLE OVERVIEW OF THAT. NEXT
SLIDE.
CULTURALLY TAYLORED --
TAILORED INTERVENTION AND
MATERIAL AND WORKSHOP ON
CLINICAL RESEARCH, I THINK THAT
IS AT THE GROUND LEVEL, WE
SHOULD BE INVOLVING THESE
ORGANIZATIONS IF WE ARE TALKING
ABOUT CLINICAL TRIALS OR THEIR
HEALTH CARE NEEDS OR RESOURCES
FOR THESE PATIENT -- THESE
ECONOMICALLY OR SOCIALLY
DEPRIVED PATIENT POPULATION.
THEN ENGAGE PROVIDERS FROM
SIMILAR BACK GROUNDS. I THINK
THAT HAS A BIG IMPACT. I LIVE IN
HOUSTON. WHEN I HAVE PHYSICIAN
WHO CAN SPEAK SPANISH WITH THE
PATIENT, UNFORTUNATELY I'M NOT
ABLE TO, BUT THEY ARE -- THEY
DEFINITELY FEEL CONNECTED WITH
THOSE PHYSICIANS OR MY
COLLEAGUES WHO CAN SPEAK SPAN,
AS THEY ARE MORE TRUSTED BY THE
MINORITY POPULATION AND BETTER
POSITIONED TO DISCUSS
PARTICIPATION BENEFITS AND
RISKS. NEXT SLIDE.
INCLUSIVE INSTITUTIONAL
POLICIES REQUIRING INFORMED
CONSENT FORMS IN DIFFERENT
LANGUAGES, PATIENT FACING
MATERIAL, MULTIPLE LANGUAGE
RELEVANT TO LOCATION'S
DEMOGRAPHIC. THIS IS ONE
CHALLENGE AT MY PLACE, WHICH WAS
THERE FEW YEARS AGO. I'M NOT
GOING TO SAY IT IS COMPLETELY
ELIMINATED, BUT MY PRIMARY GOAL
HERE IS AS A CLINICAL TRIAL
IS'-IT IS A BIG CENTER IN
PULMONARY HYPERTENSION, I
REALIZED SPONSOR DO NOT PRO ARE
VIE
PROVIDE THE FORM IN SPANISH AND
INSTITUTE DOES NOT SUPPORT
BILINGUAL FORMS OR ANYTHING LIKE
THAT. IN A HISPANIC PREDOMINANT
AREA YOU ARE AUTOMATICALLY
EXCLUDING THAT BIG PATIENT
POPULATION TO PARTICIPATE IN
CLINICAL TRIALS. CLEARLY, IF YOU
LOOK AT MY SIDE DATA, CLEARLY
REPRESENTED BY JUST THE WIDE
PATIENT POPULATION.
SO FEW YEARS AGO, AT LEAST
THREE, FOUR YEARS AGO, I STARTED
IMPOSE ING THAT ANY NEW RESEARCH
STAFF WE ARE GOING TO HIRE MUST
BE BILINGUAL. CERTIFIED IN DOING
THE CONSENTING PROCESS. THERE IS
A WHOLE INSTITUTIONAL PROCESS.
AGAIN, I FEEL LIKE THERE IS A
LOT OF RED TAPE FROM THE
INSTITUTE ALSO FROM THAT, PEOPLE
WHO ARE SPECIFICALLY NATIVE
SPANISH SPEAKING THEY HAD TO
UNDERGO TRAININGS TO PROVE THEY
COULD SPEAK SPANISH. REGARDLESS
I WILL SAY WE ARE FAR FROM A BIG
SUCCESS BUT I IN ALL HONESTY ONE
TOTALLY SPANISH SPEAKING PATIENT
IN A CLINICAL TRIAL. IT IS STILL
NOT A SUCCESS BUT A CHANGE FROM
ZERO TO ONE. AS I MENTIONED
ABOUT EMPLOYING BILINGUAL STAFF
INVOLVING RESEARCH,
INCORPORATING TELEHEALTH, IT IS
A BIG STATE AND PEOPLE DRIVE
EASILY, SO INCORPORATING
TELEHEALTH CAN HELP AND REDUCE
TRIAL -- REDUCE BURDEN ON THE
TRIAL AND CARE PROVIDER. THESE
SHOULD BE INCORPORATED IN TRIALS
KEEPING THESE THINGS IN MIND. WE
TALK ABOUT STIPEND
REIMBURSEMENT. THIS RECENTLY WAS
DOCTOR BRAND ABOUT COMPENSATION
FOR LOST WAGES. MANY OF TRIALS
AND INSTITUTES DO NOT MANDATE
COMPENSATED FOR THEIR LOST WAGES
IF COMING FOR TRIAL OR RESEARCH
VISIT. THAT IS SOMETHING SHOULD
BE VERY IMPORTANT THING, COMING
TO A CLINICAL TRIAL VISIT HAD ME
LEASE ONE DAY SALARY, I DO NOT
WANT TO PARTICIPATE IN THE
CLINICAL TRIAL. OF COURSE THE
ADDITIONAL STIPEND FOR CARE
PROVIDERS. NEXT SLIDE. WE TALK
ABOUT AFFORDABLE CARE ACT. THE
GOVERNMENT SHOULD HAVE
LEGISLATION, REMOTE CULTURALLY
TAILORED OUTREACH TO HELP
ECONOMIC AND SOCIALLY DEPRIVED
PATIENT POPULATION. NEXT SLIDE.
WE TALKED ABOUT THE CULTURALLY
COMPETENT CARE OF TRAINED
PHYSICIANS WHO ARE COGNIZANT
ABOUT THESE DIFFERENCES AND CAN
ADDRESS THOSE DIFFERENCES WITH
PATIENT, INCREASED
REPRESENTATION IN THE HEALTH
CARE FROM THE MINORITY PEOPLE
WILL DEFINITELY HELP DEVELOP
MORE CONVERSATION IN HEALTH CARE
IN GENERAL AND PARTICIPATION IN
CLINICAL RESEARCH. NEXT SLIDE.
HEALTH LITERACY AND LANGUAGE
SERVICES, TRANSLATORS SHOULD BE
EASILY AVAILABLE, ESPECIALLY FOR
CONSENTING PROCESS IN CLINICAL
TRIALS, WHICH IS VERY CONVO
CONVOLUTED, PERHAPS HAVING
DEDICATED SERVICE DEPENDING ON
WHAT PREDOMINANT LANGUAGE
SERVICE, THAT MIGHT HELP. AND
ENCOURAGE PARTICIPATION IN
CLINICAL TRIALS. NEXT SLIDE.
THIS IS ONE IMPORTANT SLIDE,
WHICH I WANTED TO HIGHLIGHT. I
THINK THIS IS NOT GOING TO BE
JUST AN INDIVIDUAL
INVESTIGATOR-DEPENDENT THING BUT
SHOULD BE MULTIPLE STAKEHOLDER
FROM PUBLIC, PRIVATE AND
NONPROFIT ORGANIZATIONS LIKE PHA
SHOULD COME TOGETHER TO ADDRESS
DISPARITIES IN CLINICAL TRIAL
PARTICIPATION, PERHAPS PROVIDE
GUIDANCE FOR NEW SPONSORS COMING
UP WITH NEWER DRUG TRIALS,
IDENTIFY ROOT CAUSE OF
DISPARITIES IN MAKING CRITICAL
POLICY CHANGES. I THINK WE
SHOULD WORK ON MAKING CLINICAL
TRIALS MORE RESPONSIVE TO
ACKNOWLEDGE THE CHANGING
EPIDEMIOLOGY. 20 YEARS AGO
PATIENTS WERE MUCH YOUNGER,
MAYBE DID NOT HAVE THAT MUCH
COMORBIDITIES, MAYBE LIVING
LONGER. SO TRIAL SHOULD BE
CHANGED OR ADAPTED ACCORDING TO
CHANGING EPIDEMIOLOGY OF DISEASE
TO ENCOURAGE MORE INVOLVEMENT OF
SUCH PATIENTS.
I'M NOT ENTIRELY SURE HOW
MUCH FDA OR NIH MANDATES OR
PROVIDES INSTRUCTIONS TO THESE
FOLKS WHO ARE CONDUCTING THE
CLINICAL TRIALS OR NEW DRUG
TRIALS OR ANY KIND OF REGISTRY,
THAT THEY SHOULD HAVE
PARTICIPATION OF HISPANIC
POPULATION OR BLACK POPULATION.
I'M NOT ENTIRELY SURE. PERHAPS
THE EXPERTS HERE FROM NIH CAN
PROVIDE INSIGHT. BUT THIS SHOULD
BE MANDATED TO EVEN A PRIVATELY
SPONSORED TRIAL OR NIH STUDY.
SUBSTANTIAL INCENTIVES FOR
APPROPRIATE INCLUSION PLANS.
NEXT SLIDE.
AGAIN, REQUIRE FURTHER GOING
INTO THIS REQUIRE DEMONSTRATION
AND PROTOCOL METHODS, PROTOCOLS
OF METHODS AND MEASURES TO
ENSURE MEANINGFUL COMMUNITY
PARTICIPATION THROUGHOUT THE
PROCESS, REQUIRE DETAILED PLAN
TO BUILD COMMUNITY CAPACITY FOR
UNDERSTANDING AND SUPPORTING THE
CLINICAL RESEARCH. REQUIRE THAT
ALL LOCAL CLINICAL TRIAL TEAMS
CONVENE COMMITTEE -- RETENTION
COMMITTEE TO REVISE PART OF THE
PLAN. I THINK THIS IS VERY MUCH
LACKING. AT LEAST I CAN SPEAK
FOR MY PLACE. PROJECTS LIKE
EDICT, I REALLY LIKE AND READ A
LOT. I THINK IT IS TIME TO COME
UP WITH SOMETHING LIKE THIS,
ELIMINATING DISPARITIES IN
CLINICAL TRIALS. THIS IS
ACTUALLY IN CANCER TRIALS, WHERE
I LEARNED MORE ABOUT IT, ARE
NEEDED IN PH AS WELL. WHERE THEY
HAVE IDENTIFIED THE ROOT CAUSES.
AWARE ONE OF MY ONCOLOGY FRIEND
TELL US THE NCI RECOGNITION,
WHICH CANCER CENTERS GET -- TO
GET, TO OBTAIN THAT RECOGNITION
THE CENS CENTERS NEED TO SHOW H
MANY THEY HAVE ENROLLED FROM
MINORITIES OR SOCIALLY OR
ECONOMICALLY DEPRIVED
ETHNICITIES IN THEIR CLINICAL
TRIALS. I DO NOT KNOW IF WE
COULD COME UP WITH SOMETHING
LIKE THAT, EVEN PHCC
ACCREDITATION OR ORIENTATION
PROCESS. NEXT SLIDE.
TO CONCLUDE RACIAL AND
ETHNIC MINORITIES ARE
UNDERREPRESENTED IN CLINICAL
TRIALS, LIMITING INSIGHT INTO
HEALTH DISPARITIES AND DRIVEN BY
ECONOMIC, LEVEL OF EDUCATION AND
LIMITED ACCESS TO HEALTH CARE.
BOTH DISEASE-AGNOSTIC AND
DISEASE-SPECIFIC INTERVENTIONS
ARE NEEDED FOR DISPARITIES.
THANK YOU FOR YOUR ATTENTION,
SORRY TO TAKE COUPLE MINUTES
EXTRA. I'M OPEN FOR ANY
QUESTIONS, THANK YOU.
>> THEY VERY MUCH, DR. SAHAY.
THAT WAS EXCELLENT. LOOKS LIKE
THERE IS A BIT OF AN ISSUE WITH
THE AGENDA. WE ARE SUPPOSED TO
BREAK FOR LUNCH FOR FIVE MINUTES
ON THE EAST COAST, MAYBE
BREAKFAST ON THE WEST. I WILL
MAKE THE EXECUTIVE DECISION TO
EXTEND 15 MINUTES INTO LUNCH. IF
EVERYONE IS OKAY. IF NOT, SIGN
OFF AND WE WILL SEE YOU AT 1:00.
LET'S TAKE 20 MINUTES TO FIELD
QUESTIONS. I WILL START THINGS
OFF BY DR. SAHAY. ASKING YOU A
QUESTION. DR. ESTRADA ALSO YOU
CAN JUMP IN. YOU BOTH AS WELL AS
DR. GOEL, ALLUDED TO THE FACT
THAT SOCIOECONOMIC STATUS,
PERHAPS SOCIAL DETERMINANTS,
WHICH WE WILL GET INTO NEXT
SESSION, ARE VERY IMPORTANT.
WHEN WE DESIGNED CLINICAL
TRIALS, COHORT STUDIES AND CASE
CONTROL STUDIES, WE DON'T
TYPICALLY ASSESS SOCIAL
DETERMINANTS OR SOCIOECONOMIC
STATUS. YOU HAVE MENTIONED IN
TERMS OF HETEROGENEITY AND HOW
TO ASSESS RACE. IS IT IMPORTANT
FOR US TO TRACK THOSE IN ALL
THOSE SITUATIONS AND IF THERE
ARE -- YOU KNOW, NORMALLY IN
RANDOMIZED CONTROL TRIAL WHEN WE
DESIGN THE TRIAL WE ASSUME BOTH
TREATMENT ARM AND CONTROL ARM
ARE THROUGH RANDOM IZATION
PROCESS THERE IS MATCHING OF IN
BOTH ARMS. IF THIS IS A
MISMATCH, HOW DO WE ASSESS IT
AND NUMBER TWO, HOW DO WE
APPROACH THAT? LET'S START OFF
WITH DR. SAHAY.
>> SO YOU ARE EXACTLY ASKING HOW
DO WE ASSESS WITH LIKE THE
SOCIOECONOMIC STATUS OF THE
PATIENT WHEN WE ARE --
>> SHOULD WE BE ASSESSING
SOCIOECONOMIC STATUS AND SOCIAL
DETERMINE NANTS AND HOW TO ADDR
IT?
>> I THINK THE SHORT ANSWER IS
YES BECAUSE THIS MORNING IN
THREE DIFFERENT TALKS WE HAVE
CLEARLY DEMONSTRATED THAT THIS
AFFECTS THEIR OUTCOMES. NO DOUBT
OF SOCIOECONOMICS STATUS SO TO
COLLECT FAR BETTER THAN PRIOR
DATA, TO COLLECT THE INFORMATION
ABOUT THEIR -- ADMIT PERSONAL
INFORMATION ABOUT THEIR INCOME,
WHERE THEY LIVE, IF THEY HAVE
BARRIERS TO COME TO THE DOCTOR'S
OFFICE OR GETTING THE
MEDICATIONS. I DO NOT REMEMBER
ME ASKING EVERY PATIENT WHEN I
SEE THEM OR THOSE PARTICIPATING
IN THE CLINICAL TRIAL HAVE THEY
-- DO THEY ROUTINELY HAVE TO
UNDERGO BARRIERS TO OBTAIN
MEDICATIONS OR PICK UP THEIR
MEDICATIONS? I THINK THESE ARE
IMPORTANT INFORMATION THAT WE
SHOULD BE COLLECTING. BECAUSE IF
WE ARE NOT ASKING THESE
QUESTIONS, FOR US THEY DO NOT
EXIST. I THINK THAT IS A BIG
CHALLENGE THERE. ONE OF THE WAYS
WHICH CURRENTLY WE ARE WORKING
WITH PDRI IS TO COME UP. I THINK
WHILE I WAS LISTENING TO THE
TALK THIS MORNING, WE ARE COMING
UP WITH A GLOBAL SORT OF -- YOU
KNOW, WHERE THE CONSENSUS ON THE
VARIABLES TO BE COLLECTED IN ANY
OF THE REGISTRY STUDY FOR PH.
CURRENTLY DIFFERENT LOGISTICS
COLLECT VARIABLES DIFFERENTLY
ALSO. AFTER THESE FIRST FEW
TAKES I SUDDENLY REALIZED IN
PROPOSALAL WE HAVE NOT TALKED
ABOUT DISPARITIESES,
SOCIOECONOMIC STATUS OR THE RACE
DATA. IT ACTUALLY HIS QUESTION,
WHEN HE MENTIONED ABOUT THAT
EUROPEANS DO NOT TALK ABOUT IT.
IT SUDDENLY DAWNEDED ON ME, YES.
BECAUSE IT IS A GLOBAL THING WE
ARE DOING. THIS WAS NOT BROUGHT
UP INTO THE CONVERSATION SO THIS
IS SOMETHING I'M GOING TO SEND
AN EMAIL THAT WE SHOULD BE
INCLUDING OR ASKING. IT STARTS
WITH US, THAT WE NEED TO START
COLLECTING THAT INFORMATION MORE
SYSTEMATICALLY, WHICH WE ARE NOT
DOING CURRENTLY.
>> DR. ESTRADA DO YOU HAVE A
STANDARDIZED WAY YOU LOOK AT
THESE VARIABLES WITH YOUR
PATIENTS IN SAN ANTONIO?
>> YEAH, I WANT TO TAKE A LITTLE
WHAT DR. HYDE SAID, I TOOK AWAY
A SLIDE WE ARE CREATING A MODEL
FOR THE U.S. BUT TRYING TO
CREATE SOMETHING THAT IS
REPLICABLE. THESE ARE
CHARACTERISTIC OF WHAT WE HAVE
NOW. THESE HAPPENED, AS I
MENTIONED IN THE SINGAPORE
PEOPLE THROUGHOUT THE WORLD. IF
WE CAN CAPTURE DATA AND HAVE IT
REPLICATED, THE SPECIFIC
QUESTION, WHEN I STARTED LOOKING
INTO THE SUBJECT, THAT LAST
SLIDE I MENTIONED WHERE THE
CENSUS IS REALLY TRYING TO
GATHER THE GRAN YULARITY,
SPECIFICALLY THE HISPANIC
POPULATION, THESE ARE SENSITIVE
QUESTIONS. THESE ARE SPECIFIC
BUT COULD DETER, TO ANSWER
FAITH FULLY. WHAT WE P SPEAK THE
MOST ABOUT ONE SPECIFIC CHANGE
IS MIGRATION PATTERNS ARE
SOMEWHAT DIFFERENT THAN OTHER
COHORTS BECAUSE OF PROXIMITY.
WHEN COMES TO SOCIOECONOMIC
STATUS, EMPLOYMENT OR INCOME,
EVEN THOUGH THEY ARE
MEASUREMENT, MAY NOT BE RELIABLY
STENTLY MEASURED WITHIN
THE POPULATION WHO MAY NOT HAVE
A STABLE JOB OR STABLE INCOME.
THEY GET MISSED. THESE ARE THE
PATIENTS WE ARE SEEING AND
PROBABLY ACCESS THE CARE. I
THINK THE FRAMEWORK WHERE WE CAN
CAPTURE POPULATION, NOT
ROUTINELY CAPTURED IN BIGGER
CENTERS, WOULD BE THE IDEAL
SCENARIO. I THINK A SURVEY
GRANDPARENT HERITAGE, KIND OF
ABOUT MIGRATION PATTERNS, WOULD
BE KEY COMPONENT TO THAT
QUESTION.
>> THANK YOU.
>> I HAVE TWO QUESTIONS FOR YOU.
BOTH WHICH YOU SORT OF ALLUDED
TO EARLIER. YOU KNOW, WHAT DO WE
KNOW ABOUT THE PROVIDERS, THE
CLINICAL TRIALISTS AND
INSTITUTIONS ENROLLING PATIENTS
AND PARTICIPANTS IN STUDIES AND
REGISTRIES? BECAUSE IF YOU ARE
COMING FROM AN INSTITUTION WHERE
YOU ONLY SEE 95% WHITE PEOPLE
AND, YOU KNOW, YOUR EXPOSURE TO
MINORITIES IS VERY SMALL, VERSUS
ANOTHER CENTER WHERE YOU MAY SEE
ALMOST EXCLUSIVELY
UNDERREPRESENTED GROUPS. YOU
KNOW, THE ABILITY TO ENROLL IS
GOING TO BE VERY DIFFERENT. SO
DO WE KNOW ANYTHING ABOUT THESE
MAJOR CLINICAL TRIALS AND PEOPLE
WHO ARE ENROLLING?
>> YES. I WOULD LIKE TO TAKE
THAT QUESTION. I LIVE IN
HOUSTON, WHICH IS A VERY DIVERSE
CITY. CULTURALLY, ETHNICITY,
RACE, WHATEVER YOU WANT TO SAY.
IT IS A VERY DIVERSE CITY, THE
FOURTH LARGEST CITY IN THE
COUNTRY. I CAN TELL YOU
HISTORICALLY, AND THERE WERE
BARRIERS THAT -- THERE ARE STILL
MULTIPLE BARRIERS TO ENROLL
PATIENTS. IT IS ALL ALONG THE
BARRIERS THAT ARE INSTITUTIONAL,
SITE AND ALSO THE CLINICAL
TRIALS. SOME OF THE POINTS I
HIGHLIGHTED AND FINE TO
HIGHLIGHT IN THE PROTOCOLS, LIKE
FOR EXAMPLE, BMI CUT-OFF OF 30,
TO ME IT APPEARS VERY
CONSERVATIVE. ESPECIALLY, I LIVE
IN TEXAS. IF YOU HAVE A CUT-OFF
OF 30 AND I SHOWED YOU THE DATA
FROM THE U.S. CENSUS DATA OR
CDC DATA THAT PREDOMINANTLY THE
AFRICAN-AMERICAN POPULATION HAD,
THAT WHOLE 60% OF BLACK WOMEN
AND ALMOST 50% OF BLACK MEN HAD
BMI ABOVE 30. THIS IS
NATIONALLY. YOU ARE
AUTOMATICALLY DISQUALIFYING
SIGNIFICANT AMOUNT OF BLACK
PATIENT POPULATION.
SIMILARLY I USE THE PFD
EXAMPLE, THE OTHER
COMORBIDITIES. IF YOU PICK UP
LAST FIVE CLINIC CAL TRIALS ACCT
DRUG TESTED DIFFERENT, TO ME
LOOK LIKE COPY EXACTLY THE SAME.
SAME EXCLUSIONARY CRITERIA, SAME
INELECTROC
INCLUSION AND DIFFERENT IN 3 BUT
IF YOU ARE LOOKING AT THE
PREDOMINANT DATA THEY ARE PRETTY
MUCH DONE THE SAME WAY. PD, FB
EXCLUDES AFRICAN-AMERICANS AND
OBESITY IS PREVALENT IN HISPANIC
POPULATION. WE EXCLUDE THEM. WE
KNOW INCREASE RISK FOR
OBSTRUCTIVE AIRWAY DISEASES. SO
CLEARLY YOU ARE -- WE ARE NOT
TALKING ABOUT THE LANGUAGE ISSUE
BUT EVEN WITH THE CO. MORBID
CONDITIONS WHICH MAY OR MAY NOT
HAVE THAT IMPLICATION OF
PERMANENT VASCULAR DISEASE BUT
THESE PATIENTS ARE BEING
EXCLUDED. SO THE QUESTION IS,
WHAT SHOULD WE DO? I FEEL WE
NEED TO BE MORE ADAPTIVE TO
CHANGING EPIDEMIOLOGY OF
DISEASE. WE ARE NOT DOING THE
TRI
TRIALS WHEN EVERYONE THE CLASSIC
DEFINITION WAS EVERYONE WAS
YOUNG-WE KNOW ALL AGE GROUPS WE
ARE SEEING SO PERHAPS NEED TO
CHANGE THOSE PROTOCOLS. SOME OF
THE POINTS I HIGHLIGHTED ABOUT
INSTITUTION ALSO INVOLVING MORE
BILINGUAL STAFF, WE DIDN'T HAVE
EARLIER, HIRED BILINGUAL STAFF
TO ENCOURAGE ENROLLMENT. THERE
ARE INSTITUTIONAL BARRIERS AS
WELL.
>> AGREED. MY QUESTION IS DO WE
KNOW ANYTHING ABOUT THE RACE AND
ETHNICITY OF CLINICAL TRIALISTS,
MAYBE THOSE DESIGNING THE STUDY
PROTOCOLS AND MAKEUP OF THE SAY
INSTITUTIONS THAT ARE ENROLLING?
WE TALK A LOT ABOUT
UNDERREPRESENTATION IN CLINICAL
TRIALS, ET CETERA, BUT, YOU
KNOW, THERE IS MORE THAN ONE
SIDE TO THIS THAT NEEDS TO BE
ADDRESSED SO I'M ASKING ON THE
FLIP SIDE OF THINGS.
>> I CANNOT SPEAK FOR THE WHOLE
COUNTRY BUT I CAN SPEAK ABOUT MY
PROGRAM, WHICH IS IN TERMS OF
HEALTH CARE PROVIDERS IS FAIRLY
DIVERSE. LIKE RIGHTLY POINTED
OUT THAT FOLKS INVOLVED IN TRIAL
DESIGN AND ALSO THE INDIVIDUAL
HEALTH CARE PROVIDER SHOULD BE
EQUALLY DIVERSE TOO TO
ACKNOWLEDGE THAT DIVERSITY IN
THE PATIENT POPULATION. THAT IS
A FAIR POINT.
>> MAY I ADD SOMETHING TO IT? I
THINK IT IS A GREAT POINT. THE
CULTURAL COMPETENCY TO ADDRESS
QUESTIONS WITHIN TRIALS, IF YOU
DON'T KNOW WHAT YOU DON'T KNOW,
IT IS HARD TO HAVE THAT
CONVERSATION. I THINK ONE POINT
OF THAT AND SOMETHING WE CAN
THINK ABOUT INTERVENTION IS IF
YOU THINK ABOUT PLACES THAT HAVE
TRIALS, ARE USUALLY THE SIGN TO
DO TRIALS. WHETHER A BIGGER
INSTITUTION, BIGGER ECONOMIC
CENTER, THERE ARE PROVIDERS WHO
DO WANT TO DO TRIALS BUT DON'T
KNOW HOW TO START. I HAD
PERSONAL EXPERIENCE WHEN I JO
JOINED WE DIDN'T KNOW AND I HAD
GREAT MENTORS THAT COULD HELP.
MAYBE AS COMMUNITY WE COULD DO A
MENTORSHIP PROGRAM, IF SOMEONE
WANTS TO DO A TRIAL, NEW MEXICO
OR SOMEWHERE ELSE, WHERE WE MAY
HAVE CERTAIN MORE DIVERSE
POPULATION THAT WE ARE NOT
GETTING TO AND THERE IS AN
INTERESTING PROVIDER, WE CAN
SUPPORT THEM IN A WAY THEY DON'T
FEEL THEY ARE BY THEMSELVES
TRYING TO BUILD UP A RESEARCH,
GROUP OR TRIAL GROUP.
>> I HAVE A FOLLOW-UP COMMENT ON
THIS. IN ONE OF THE SLIDES I DID
MAKE A POINT THAT DO WE KNOW
REGARDLESS OF THE PVD ANY OTHER
DISEASES THAT NIH OR FDA
MANDATES PRIVATE SPONSORS OR
STUDIES THAT YOU NEED TO HAVE
CERTAIN PERCENTAGE OF PATIENT
POPULATION REPRESENTING HISPANIC
OR BLACK, INCONSISTENT WITH
POPULATION OR DEMOGRAPHICS. I'M
NOT AWARE OF THAT. I FEEL UNLESS
NIH OR FDA MANDATES THAT TYPE OF
THING, I THINK THAT IS ONE OF
THE ROOT CAUSE ISSUES WHICH CAN
ADD TRESZ THERE. I DON'T KNOW
ABOUT THAT PART.
>> I CAN HELP TO ADDRESS THAT. I
WAS INTENDING TO ANSWER A
QUESTION. I CAN'T HELP ON THE
FDA BUT NIH, THIS IS WHILE
MAINTAINED REQUIRED ISSUE FOR
THE OLDER (?) TRIAL ENROLL
PATIENTS. IF YOU GET FUNDED
BEFORE FOR THIS TYPE STUDY THERE
WILL BE INCLUSION ENROLLMENT
RECORD TABLE WHEN YOU SUBMIT
YOUR APPLICATION. THAT IS A
TABLE SPECIFICALLY MENTIONED,
YOU HAVE TO DESCRIBE HOW MANY
YOU PLAN TO ENROLL AND ONCE
RACIAL AND ETHNICITY DIVERSITY
FOR THIS. SO ASK THE SPECIFIC
FOR MEMBERS IN EACH CATEGORY.
THIS WILL BE AN ANNUAL REPORT.
WE AS PO, PROGRAM OFFICER, WE
WILL REVIEW ENROLLMENT IN
PROGRAM. NOT ONLY TOTAL NUMBER
BUT DIVERSITY. THIS IS A
REQUIREMENT FOR US IN THAT JOB.
OF COURSE WE HAVEN'T HAD A FIXED
NUMBER FOR EACH RULE HOW MANY
PATIENT WE HAVE. THIS IS
PROBABLY NOT REALISTIC FOR
CERTAIN INVESTIGATORS IN CERTAIN
AREA, BUT THIS IS DEFINITELY YOU
HAVE TO PUT IT IN THERE. SO THAT
IS WHY THIS IS REQUIRED ITEMS
FOR CLINICAL STUDY. IF YOU --
JUST SAY YOU APPLICATION ONLY
INCLUDES SAY WE ARE ENROLLED
TOTALLY CAUCASIAN POPULATION,
YOUR GRANT WILL NOT BE FUNDED SO
THIS IS THE PRESSURE ABOUT THAT.
SO YEAH, THAT IS -- TRY -- I
THINK FDA HAVE SIMILAR PROBABLY
POLICY, BUT I COULD NOT ANSWER
ON BE HALF OF THEM.
>> THANK YOU. DR. ORTEGA.
>> YOU KNOW, MY COMMENT IS MORE
AS WE LOOKOUT -- LOOK OUTWARD
TO INCREASE CLINICAL TRIALS IT
IS IMPORTANT TO LOOK INWARDS FOR
TRIALS. WE ARE TRYING TO RECRUIT
AS MANY PATIENTS AS FAST AS
POSSIBLE. THAT USUALLY DEFAULTS
TO THE MOST CONVENIENT SAMPLE.
YOU KNOW WHAT I MEAN? OUR
PATIENTS THAT ARE THE MOST
CONSISTENTLY, OH THIS IS THE
BEST PATIENT WE HAVE. INSTEAD OF
TAKING ALL YOUR PATIENTS,
THROWING ALL IN A HAT AND
RANDOMLY PICKING YOUR NEXT
PATIENT TO DO THE BEST JOB, THE
MOST AVAILABLE, THE MOST
CONVENIENT. I THINK WE HAVE TO
LOOK IN MORE AND BE MORE WILLING
TO TAKE ON PATIENTS THAT ARE
GOING TO BE HARDER TO BRING IN.
THAT ALSO IS HARD ON
INFRASTRUCTURE, RIGHT. LIKE WE
REALLY HAVE TO HAVE PEOPLE WORK
ON WEEKENDS. BECAUSE THOSE
POPULATIONS THAT ARE HIT THE
HARDEST DON'T NECESSARILY --
MAYBE THEY ARE WORKING TWO JOBS.
THERE'S REASONS. IT IS --
UNFORTUNATELY, IT IS A VICIOUS
CYCLE THAT FEEDS ONTO ITSELF FOR
THIS. I THINK WE HAVE TO LOOK
INWARD, LOOK AT OUR STRATEGIES
AS WELL. AND I HEARD THE BELL.
>> YEAH, ACTUALLY I AGREE WITH
DR. ORTEGA'S COMMENT. WE HAVE --
I JUST WANT TO SHARE WITH YOU,
SOME OF THE (?) MANAGING THE
TRIAL, THERE WAS A STUDY
REALIZED CAUCASIAN IS LIMITED TO
SHOULD HAVE AND LACK IN BLACK
POPULATION SO TELL THE
INVESTIGATORS OF THE STUDY TO
START RECRUITING MORE CAUCASIAN
PATIENT, THEY HAVE ONLY FOCUSED
ON MINORITIES BECAUSE THEY ARE
-- OVER THE QUOTA FOR CAUCASIAN
POPULATION. THIS IS REALLY
HAPPENING FOR THE NIH-FUNDED
STUDY. AS YOU SAID SOME OF -- IT
IS MORE CONVENIENT -- DEPENDS ON
WHERE THEY ARE LOCATION --
PROBABLY EASIER FOR INVESTIGATOR
IN CERTAIN POPULATION BUT SINCE
FUNDED BY NIH THIS IS REQUIRED
SO HAVE CERTAIN TIME THEY HAVE
TO MAKE SURE THEY ARE CATCHING
UP WITH THE MINORITY POPULATION
TOO, SO THAT IS PART OF THE
REQUIREMENT.
>> IN LITERATURE THERE ARE
EXAMPLE OF MINORITY GIVEN LESS
OR COMBINATION DRUGS. THERE ARE
INHERENT BIASES THAT EXIST AND
APPLY TO THERAPIES IN MORE
ADVANCED CLINICAL TRIALS. WHY IT
EXISTS, WHO KNOWS BUT WE NEED TO
RECOGNIZE AND GO FOR THAT
EXAMPLE.
>> YOU CAN ADD TOO, THAT MAY BE
PROVIDER BIAS. YOU KNOW, BECAUSE
OF DIVERSE -- YEP, SO THOSE
THINGS NEED TO BE INCORPORATED
AS WELL.
>> I ALWAYS SAY PHYSICIAN BIAS,
WHEN YOU DECIDE WHAT TREATMENT
IS GOOD FOR YOU INSTEAD OF
PATIENT TELLING YOU WHAT THEY
DESIRE OR WHAT GUIDELINE
RECOMMENDS THAT PATIENT SHOULD
BE ON. I THINK YOU BROUGHT UP A
VERY REALISTIC -- DR. ORTEGA,
YOUR POINT IS VERY WELL TAKEN.
THIS IS A VERY REAL -- RUNNING A
CLINICAL TRIAL ISSUE THAT YOU
BROUGHT UP. THIS IS LIKE AN
EVERYDAY CONVERSATION WITH MY
TEAM. OH, WHICH PATIENT SHOULD
WE ENROLL, WHETHER THIS PATIENT
IS GOING TO BE RELIABLE TO
PARTICIPATE IN THE CLINICAL
TRIAL. SOME WERE RANDOMLY, SOME
WERE IN THE CHART DOCUMENTED FOR
WHATEVER REASON, THE PATIENT
MISSED TWO DOSES OR
NON-COMPLIANT, LIKE DOCUMENTED
IN OUR RECORDS AND THIS PATIENT
FOREVER IS LABELED AS
NON-COMPLIANT. WHEN I GO AND I
HAVE A DIFFERENT OPINION AND MY
RESEARCH NURSE REVIEWS THE CART
AND SHE WILL HAVE A DIFFERENT
OPINION AND I HAVE TO HAVE THIS
CONVERSATION AGAIN THAT NO, THIS
COULD BE. BUT I THINK THIS IS A
VERY MUCH REAL LIFE ISSUE, WHAT
YOU BROUGHT UP. THAT IS WHERE
THE BIASES START, PRETTY MUCH.
>> I THINK WE ARE NEARING OUR
POINT WHERE WE MAY HAVE TO
ADJOURN, BUT I THINK DR. ORTEGA
BROUGHT UP A VERY IMPORTANT
POINT, JUST TO REITERATE. AND
PART OF MY INITIAL POINT OF
MAKING THAT WE DON'T KNOW
SOMETIMES OUR OWN BIASES. THE
BIASES WE INCORPORATE WHEN WE
ARE DESIGNING TRIALS OR
GUIDELINES THAT MAY BE RELIANT
ON PREVIOUS RESEARCH THAT WAS
BIASSED.
IS THERE ANYTHING -- BEFORE
WE ADJOURN IS THERE ANYTHING WE
CAN DO IN THE DESIGN PHASE OF A
TRIAL, WHETHER IT IS US OR
INDUSTRY OR WHATEVER ELSE,
SHOULD WE BRING IN MORE OPINIONS
TO EXAMINE OUR OWN BIASES AND
HOW THOSE MIGHT LAYOUT WHEN IT
COMES TO THE TRIAL RESULTS OR
WHAT ARE YOUR RECOMMENDATIONS?
>> I DON'T THINK WE -- I JUST
HAVE ONE COMMENT TO MAKE ON THAT
PART. I SEE SO MANY CLINICAL
TRIALS PROTOCOLS ON REGULAR
BASIS, FROM DIFFERENT INDUSTRY
SPONSORS OR ANYONE. I AM YET TO
SEE A PROTOCOL WHERE ANY OF THE
SPONSORS HAVE SPECIFIED THAT NOT
AS A TOOL BUT AS ENCOURAGEMENT.
THAT WE ENCOURAGE PARTICIPATION
FROM A DIVERSE PATIENT
POPULATION, AS REQUIRED BY THE
FDA, OR EXPECTED BY THE FDA NOT
EVEN REQUIRED. I DON'T THINK --
WE DON'T EVEN TALK ABOUT THAT.
WHEN YOU DO NOT TALK ABOUT THAT,
THIS IS DEFINITELY OVERLOOKED. I
THINK WE NEED TO START
CONVERSATIONS SOMEWHERE THAT WE
START DOCUMENTING THESE IN THESE
-- I DON'T THINK THERE IS GOING
O BE ANY HARM OR DOWNSIDE OF
THAT. BUT IF YOU START
DOCUMENTING THAT HEY, WE
ENCOURAGE THE PATIENT -- IF YOU
ARE LOOKING A SITE IN TEXAS OR
ARIZONA, HEAVILY HISPANIC
POPULATION, PREDOMINANT AREAS,
WE ENCOURAGE THAT YOU ENROLL
MORE HISPANIC PATIENT
POPULATION. SUDDENLY, PEOPLE
WILL START TO THINK ABOUT IT.
BECAUSE CURRENTLY NO ONE EVEN
THINKS ABOUT IT. THAT IS JUST MY
COMMENT. I DON'T KNOW WE CAN
MANDATE TO THE PRIVATE SPONSORS,
BUT AT LEAST MAKING THIS
REQUIREMENT AT LEAST DO
DOCUMENT, SO THAT THE
INVESTIGATOR OR THE RESEARCH
TEAM, WHOEVER IS REVIEWING THOSE
PROTOCOLS, CAN START THINKING
ABOUT IT. I CAN MAKE IT PART.
THE IRB, WHO KNOWS HOW THEY WILL
DIFFERENTIATE THE INDIVIDUAL
IRBs.
>> THANK YOU. YOU KNOW, INDUSTRY
HAS THEIR GOALS.
>> YEAH.
>> THEY HAVE THEIR GOALS. THEY
ARE IN THE PRESSURE COOKER LIKE
WE ARE. IF YOU ARE IN A PRESSURE
COOKER AND GOT TO RECRUIT YOU
WILL BE LESS LIKELY TO RECRUIT
PEOPLE YOU THINK ARE LESS LIKELY
TO BE HARD OR LIKELY TO FOLLOW.
THAT IS THE WAY IT IS. THERE HAS
TO BE AWARENESS AND HAS TO BE
ACCOUNTABILITY TO THOSE BODIES,
THOSE INDUSTRIAL BODIES. NHLBI
DOES PROVIDE ACCOUNTABILITY. I
HAVE HAD TO FILL THOSE TABLES
OUT A LONG TIME. I DON'T KNOW
HOW MANY GET REJECTED BASED -- I
DON'T KNOW THE FORMULA FOR
REJECTION. IF THERE IS ANY
USEFUL USE FOR THESE
NON-BIOLOGIC RACE/ETHNICITY
THINGS IT IS TO MAKE SURE WE ARE
ACTUALLY FILLING THOSE TABLES
OUT AND RECRUITING DIVERSELY. IF
THERE IS ANY GOOD USE, THAT
WOULD BE ONE FOR SURE, BECAUSE
IT IS NOT GREAT PRINCIPLE WE'VE
GOT BUT IT IS A MATTER OF --
DON'T KNOW HOW WE DO THIS, BUT
THAT AWARENESS, I CAN'T GET AWAY
FROM THE FACT THIS BEHAVIOR IS
JUST SOMETHING THAT WE'VE ALL
PROBABLY DONE IT. WE WANT TO
RECRUIT. WE HAVE OUR PATIENTS
THAT ARE OUR FAVORITE PATIENTS.
THAT IS NOT FAIR. WHAT IS FAIR
IS TAKING ALL THE PATIENTS,
PUTTING THEIR NAMES IN A HAT AND
RANDOMLY PICKING A NUMBER. OH,
THIS ONE IS... WHO CARES, THIS
IS JUST, THIS IS FAIR TO INCLUDE
THESE PATIENTS. THOUGH IT WILL
BE HARDER TO MAKE SURE THIS
PATIENT IS COMPLIANT. THAT IS AN
INHERENT BIAS. WOULD THEY REALLY
BE THAT HARD TO BE IN A TRIAL?
THAT IS ACTUALLY A BIAS. I JUST
SAID IT, A BIAS. I DID THAT
INTENTIONALLY, LIKE I'M AWARE OF
THE BIAS. THERE ARE
SELF-ADMINISTERED TESTS ON BIAS
I WOULD ENCOURAGE. IT IS A
MATTER OF AWARENESS IN INDUSTRY
AT ALL LEVELS BUT WHAT IS THE
MAGIC FORMULA? WE ALSO HAVE TO
LOOK INWARD. WE ARE PEOPLE WHO
TALK TO INDUSTRY, CONNECTED TO
THOSE CLINICAL TRIALS. IT IS
REALLY -- WISH I HAD A BETTER
ANSWER THAN THAT BUT PROBABLY
WHAT I GOT.
>> ALL RIGHT. THANK YOU VERY
MUCH, DR. ORTEGA. I WANT TO
ENCOURAGE EVERYONE TO LOOK AT
THE GREAT COMMENTS WE HAVE FROM
DOCTORS GLEN AND VENTETUOLO IN
THE CHAT. ALSO THERE IS A
QUESTION REALLY QUICK ON
DISTENSIBILITY AND DEMOGRAPHY.
DID TENSABILITY IS DETERMINED BY
RIGHT HEART CATEGORITIZATION AND
RELATIONSHIP TO DISTENSIBILITY,
SEX, AGE, ALTITUDE. NONE OF
THOSE FACTORS WERE REFERENCED BY
THE CHEST PUBLICATION. IN ANY
CASE, THE POINT HERE IS THAT
AFRICAN-SUB SAHARANS MAY
INFLUENCE DISTENSIBILITY BY
ENVIRONMENT IN WHICH THEY GREW
UP. THAT WAS OVERLOOKED BY THE
INITIAL STUDY IN 1985. IF IT IS
OVERLOOKED CONTINUOUSLY THROUGH
GUIDELINE PRESENTATION, THEN WE
MAY MISS THE BALL THERE. SO IN
ANY CASE, LET'S ADJOURN. SORRY
FOR THE DELAY FOR YOUR LUNCH ON
THE EAST COAST. WE WILL
RECONVENE IN APPROXIMATELY 40
MINUTES-ISH WITH THE SEX AND
GENDER DIFFERENCES SESSION, THANK YOU. (LUNCH BREAK)
>> AFTER GOOD LUNCH ON EAST
COAST, BREAKFAST ON THE WEST AND
SOMEWHERE IN BETWEEN... IF WE
ARE READY, CAN WE -- ARE WE
READY, SHAUN, TO START?
>> YES, SIR, WE ARE.
>> OKAY, GREAT. WITH THAT I WILL
INTRODUCE THE NEXT SESSION, SEX
AND GENDER DIFFERENCES WITH
THOSE WITH PULMONARY VASCULAR
DISEASE.
DISEASE. TAKE IT AWAY, DR.
STHAH.
>> WE DON'T SEE THEM YET.
>> I THOUGHT IT WAS ME.
>> THAT ODD, BECAUSE I DO SEE
THEM.
>> DR. HORN SEES THEM.
>> DON'T SEE THEM. MOST
IMPORTANT THING IS DR. STRAH.
>> AT THE TOP OF THE SCREEN.
>> WONDERFUL, THANK YOU.
>> I WANT TO THANK YOU. IT IS AN
HONOR. I'M HEATHER STRAH FROM
THE UNIVERSITY OF NEBRASKA AND
TALKING ABOUT INTERSECTION OF
SEX, GENDER AND PULMONARY
DISEASE. NEXT SLIDE, PLEASE.
OKAY. FIRST I WOULD LIKE TO
CLARIFY THIS A BROAD TERM THAT
REFER TO A BROAD GROUP OF
INDIVIDUALS THAT DO NOT IDENTIFY
TO SEX ASSIGNED AT BIRTH,
TRANSGENDER HAVE VARYING DEGREES
OF EXPRESSION AND ALL ARE
INDEPENDENT OF MEDICAL CARE AND
PHYSICAL APPEARANCE. I MIGHT USE
TRANSGENDER, GENDER-DIVERSE, TGT
SYNONYMOUSLY DURING THIS TIME
AND WILL BE BEST TO BE CLEAR IF
I'M REFERRING TO A
GENDER-SPECIFIC GROUP. SHAUN,
WILL YOU PROVIDE GUIDANCE FOR
PEOPLE IN THE CHAT TO SEE
SLIDES.
>> IF YOU ARE NOT SEEING SLIDES
AT THE TOP OF YOUR ZOOM, WHERE
YOU SEE YOUR NAME, SHAUN PATTON,
IF YOU CLICK ON THAT IT SHOULD
LET YOU SEE MY SCREEN.
>> OKAY. DURING THIS TALK I WILL
SMEVE
MENTION THE TRANSGENDER SURVEY
BY THE CENTER FOR EQUALITY. THE
TRANSGENDER SURVEY WAS PERFORMED
IN 2015, UPDATED IN 2022. IT
INCLUDED ALMOST 85,000 ADULT
TRANSGENDER INDIVIDUALS. DATA IS
STILL BEING ANALYZED AND
PROVIDES INVALUABLE INSIGHTS
INTO THE EXPERIENCES AND NEEDS
OF THE TRANSGENDER COMMUNITY. I
WANTED TO PROVIDE THIS CONTEXT
NOW FOR WHEN IT IS REFERENCED
LATER. NEXT SLIDE, PLEASE. OKAY.
WHILE OTHERS WILL SPEAK MORE
SUBSTANTIALLY ABOUT SEX
DIFFERENCES AND PULMONARY
HYPERTENSION I WANT TO TOUCH ON
THIS TALK AS IT WILL INFORM THE
DISCUSSION.
THERE'S BEEN LONGSTANDING
KNOWLEDGE FEMALE SEX IS A RISK
FAR TOR. REGISN FACTOR. REGISTR
ILLUSTRATED THE PREDOMINANCE.
DESPITE THIS MALES HAVE WORSE
LONG-TIME SURVIVAL. THE
ASSOCIATION REGISTRY IS NO
DIFFERENT, AND IT TOO
DEMONST
DEMONSTRATES THAT PH SEEMS MORE
EQUAL. IN THE JLT PUBLICATION
THE PULMONARY HYPERTENSION
REGISTRY INVESTIGATORS
DEMONSTRATED AND PROVED SURVIVAL
IN FEMALE PATIENTS. 25
TRANSGENDER WERE EXCLUDED FROM
THE ANALYSIS. WHILE I'M GREATLY
OVERSIMPLIFYING THIS ELEGANT
WORK, THE AUTHORS, ONE OF WHOM
WE WILL HAVE THE PLEASURE OF
HEAR ING FROM, NOTE MALE WITH
PAH MORE OFTEN HAD DRUG AND
TOXIN DISEASE FOR PULMONARY
HYPERTENSION AND HIV-RELATED
DISEASE AND SUGGEST PERHAPS A
MORE SIGNIFICANT ASSAULT WAS
REQUIRED TO REQUIRE PH IN MALE
PATIENTS THAN IN FEMALE
COUNTERPARTS WHICH CONTRIBUTES
TO THE POORER OUTCOME. IN TWO
PUBLICATIONS LOOKING AT HORMONES
IN MALES WITH PAH, HIGHER
ESTRADIOL AND LO LOWER
TESTOSTERONE WERE ASSOCIATED.
THE PDOLPIC SUGGESTED LONGER
EXPOSURE WAS ASSOCIATED WITH
BETTER PRESSURE AND RF FUNCTION
IN FEMALES. WHAT WE KNOW IN CIS
GENDER THAT IT IS FAR FROM
RESOLVED. I WOULD LIKE TO
DISTINGUISH BETWEEN SEX AND
GENDER AND DEFINE TERMS. SEX
WITH A BIOLOGICAL CONSTRUCT
DEFINED BY GENETIC, AN MATOMY A
HORMONES AND ASSIGNED. GENDER IS
A SOCIAL CONSTRUCT IN WHICH
RULES AND NORMS, EXPECTATIONS
AND POWER STRUCTURES ARE BASED.
HOW PEOPLE EXPRESS GENDER VARIES
GEOGRAPHICALLY, EVOLVES
GENERATIONALLY, DIFFERS WITHIN
SUBSETS OF SAME SOCIETY AND
DIFFERENT SOCIETIES. THERE ARE
OVER 1.4 MILLION PEOPLE IN U.S.
THAT IDENTIFY AS TRANSGENDER OR
GENDER-DIVERSE. 2% IN HIGH
SCHOOLS ARE QUESTIONING THEIR
GENDER. 0.5 ADULTS ARE
TRANSGENDER. CIS GENDER IS ONE
WHO IDENTIFIES WITH THE GENDER
AT BIRTH. CIS NORMA TIFFTY
ASSUMES CIS GENDER IS NORMAL OR
REFERENCE STATE AND TRANSGENDER
IS THE ALTERNATIVE STATE.
PERVASIVENESS IS FOUND IN HEALTH
CARE, AND RESEARCH, INCLUDING
SOME OF THE RESEARCH PRESENTED
HERE. GENDER AFFIRMATION IS
ACCEPTING INTERNALLY AND
EXPRESSING OUTWARDLY GENDER.
THIS IS A PROCESS THAT MAY BE
PSYCHOLOGICAL AND ACCEPTING
ONE'S IDENTITY, REJECTING
INTERNALIZED STIGMA AND
INTERNATIONALIZING PRIDE. MAY BE
SOCIAL BY CHANGING ONE'S NAMES
AND PRONOUNS, SEEKING SOCIAL
SUPPORT, CHANGING ONE'S GENDER
EXPRESSION. LEGAL, BY LEGALLY
CHANGING ONE'S GENDER AND
MARKER. MAY BE MEDICAL, BY
SEEKING GENDER-AFFIRMING MEDICAL
CARE, PROTOCOLS FOR CROSS-SEX
HORMONE THERAPY ARE BASED ON
DECADES OF EXPERIENCE OF WHAT
HAS BEEN EFFECTIVE BUT THOSE
FINDING, RCTs, HAVE NEVER BEEN
PERFORMED. IT IS ASSUMED (AUDIO
INTERRUPTION) TOWARD MALE OR
MALE-FEMALE BUT UNKNOWN IF THESE
TARGET LEVELS ARE APPROPRIATE.
UP TO ONE QUARTER OF TRANSWOMEN
DO NOT ACHIEVE THE DESIRED
DEGREE OF ANDROGEN SUPPRESSION
EVEN WITH ESTROGEN LEVELS
COMPARABLE TO MALE-FEMALES.
CROSS-SEX HORMONE THERAPY IS
TAKEN FOR SUBSTANTIALLY LONGER
THAN HORMONE THERAPY S HAVE EVER
BEEN STUDIED IN ANY PATIENT
POPULATION. LITERATURE DOES SHOW
THAT GENDER AFFIRMATION, IN
PARTICULAR MEDICAL AFFIRMATION,
IS ASSOCIATED WITH IMPROVED
OUTCOMES BOTH PSYCHOLOGICALLY
AND MEDICALLY. NEXT SLIDE,
PLEASE.
OKAY. THESE SLIDES ARE
DIFFERENT FROM THE ONES I SENT
YOU SO WE ARE GOING TO WORK
THROUGH THIS. OKAY. THE
INTERSECTION ALLTY OF GENDER
STATUS ALONG WITH OTHER
CONDITIONS SUCH AS SOCIOECONOMIC
STATUS AND RACE PUTS PEOPLE AT
RISK. SURVEYS EXAMINING THE
SOCIAL DETERMINANTS OF HEALTH
OUTLINED IN HEALTHY PEOPLE 2030
HAVE SHOWN THE TRANSGENDER
COMMUNITY IS AMONG THE HIGHEST
RISK FOR HEALTH DISPARITIES.
LIVING WITHIN THE INTERSECTION
OF RACE, GENDER MINORITY AND
FEMALE DISEMPOWERMENT BLACK AND
LATINA TRANSWOMEN EXPERIENCE
HIGHER RATES OF VIOLENCE,
SUICIDE AND H.I.V. A.I.D.S. THAN
ANY OTHER SEGMENT OF THE
POPULATION. BECAUSE GENDER
IDENTITY IS NOT REPORTED ON U.S.
DEATH CERTIFICATES THE EXACT
STATISTICS ARE NOT KNOWN.
GENDER-DIVERSE INDIVIDUALS
EXPERIENCE STARTGINGLY HIGH RATS
OF POVERTY, ISOLATION, HOUSING
INSECURITY AND VICTIMIZATION,
WHEN COMPARED WITH THE GENERAL
POPULATION. SPEAKING
SPECIFICALLY TO HEALTH, MANY
TRANSGENDER INDIVIDUALS REPORT
DELAY
DELAYING SEEKING MEDICAL CARE
DUE TO REFUSAL OF CARE OR
MISTREATMENT. MANY TRANSMEN
REQUIRE ROUTINE GENE LOGIC CARE.
IT IS HARD TO FIND BECAUSE THEY
MAYBE ARE REFUSED CARE OR A
PROVIDER MAY HAVE MORAL
OBJECTIONS AND DECIDE THEY WON'T
PROVIDE A ROUTINE PHYSICAL EXAM.
FURTHER RECEIVING CARE AT A
WOMEN'S HEALTH CLINIC IS
GENDER-NON-AFFIRMING. SO MANY
TRANSMEN JUST AVOID TREATMENT IN
GENERAL. SIMILARLY, CHANGING
ONE'S GENDER MARKER ON LEGAL
DOCUMENTS IS GENDER-AFFIRMING
AND ASSOCIATED WITH APPROVED --
IMPROVED OUTCOMES. ON THE OTHER
HAND, INSURANCE COMPANIES MAY
DENY MEDICALLY APPROPRIATE
PROCEDURES IF INCONGRUENT WITH
THE MARKER THEREFORE TRANSGENDER
MEMBERS MAY BE DEPRIVED AN
ANATOMICALLY APPROPRIATE
SCREEN
SCREENINGS. NEXT SLIDE, PLEASE.
SO GENDER-AFFIRMING MEDICAL
CARE STARTS WITH MEDICAL CARE,
PROVIDING -- OR NOT PROVIDING
GENDER-AFFIRMED MEDICAL CARE
THROUGH LACK OF AWARENESS. FOR
INSTANCE, BY USING THE TERM SEX
AND GENDER INTERCHANGEABLY.
IN THE 2022 UPDATE OF THE
U.S. TRANSGENDER SURVEY, ALMOST
HALF OF TRANSGENDER INDIVIDUALS
WERE REPORTED NEGATIVE HEALTH
CARE EXPERIENCE. ONE-THIRD
REPORTED A NEGATIVE HEALTH CARE
EXPERIENCE IN THE LAST YEAR.
NEGATIVE HEALTH CARE EXPERIENCES
RANGE FROM BEING MIS-GENDERED OR
DEAD NAMED TO EXPLAIN AND BE
DENIED APPROPRIATE CARE BECAUSE
OF YOUR TRANSGENDER STATUS.
MISPERCEPTIONS ABOUT WHAT IT
MEANS TO BE TRANSGENDER ARE
PERVASIVE, WITH WIDESPREAD
ASSUMPTIONS THAT TRANSGENDER
PEOPLE ALL WANT OR RECEIVE
CROSS-SEX HORMONE THERAPY. IN
REALITY APPROXIMATELY 78% OF
TRANSGENDER AND GENDER-DIVERSE
INDIVIDUALS WANT HORMONE
THERAPY. ONLY 44% ARE CURRENTLY
TAKING CROSS-SEX HORMONE
THERAPY. INSURANCE IS A
SIGNIFICANT BARRIER TO OBTAINING
HORMONE THERAPY. 25% OF PATIENTS
HAVE HAD CROSS-SEX HORMONE
THERAPY REFUSED BY THEIR
INSURANCE CARRIER. 14% OF
PATIENTS IN THE USTS SURVEY IN
2015 WERE UNINSURED, COMPARE ED
WITH 11% OF THE U.S. POPULATION
THAT YEAR. ONLY 25% OF
TRANSGENDER INDIVIDUALS HAVE HAD
GENDER-AFFIRMING SURGERIES. MANY
DON'T DESIRE GENDER-AFFIRMING
SURGERIES. SO AS HEALTH CARE
PROVIDERS PROVIDING PH CARE, WE
NEED TO RECOGNIZE THAT BECAUSE
PREVALENCE AND OUTCOMES ARE
INFLUENCED BY SEX ASSIGNED AT
BIRTH AND HORMONES WE SHOULD
OBTAIN A SURGICAL HISTORY
CLARIFYING WHETHER OR NOT GONADS
WERE REMOVED IN THE SURGERIES,
ALONG WITH MEDICATION HISTORY IN
ALL TRANSAND NONBINARY, AND
IMPORTANT FOR WOMEN WHO MAY NOT
HAVE RECEIVED THE NON-ANDROGEN
THERAPY. NEXT SLIDE, NEXT,
PLEASE -- SORRY, CAN YOU GO
BACK? THANK YOU. OKAY.
SO WE RECOGNIZE THAT
TRANSGENDER INDIVIDUALS DO
EXPERIENCE GREATER PSYCHOLOGICAL
STRESS THAT AIR FORCE BASES
PHYSICAL HEALTH, IN ADDITION TO
RISK CONDITIONS THAT OCCUR WITH
GREATER FREQUENCY THAN GENDER
MINORITY INDIVIDUALS. FOR
INSTANCE SMOKING OCCURS AT
ROUGHLY TWICE THE RATE OF
GENERAL POPULATION PRIMARILY AS
A RESULT OF TARGETED MARKETING
BY THE TOBACCO INDUSTRY. IN THE
FOUR PATH SURVEY PUBLISHED IN
22, 40% WERE CURRENT TOBACCO
USERS COMPARED TO 19% OF
CISGENDER INDIVIDUALS. OBESITY
HAS A HIGHER PREVALENCE IN
TRANSGENDER ADULTS. BOTH
TRANSGENDER MEN AND WOMEN
EXPERIENCE WEIGHT GAIN AS A
RESULT OF THE TRANSGENDER
HORMONE THERAPY. IN A
LONGITUDINAL STUDY OF TDG
PATIENTS ON GENDER-AFFIRMING
THERAPY, UP TO 30% OF PATIENTS
EXPERIENCED GREATER OF FIVE KILO
WEIGHT GAIN IN 21 MONTHS
FOLLOWING INITIATION OF HORMONE
THERAPY. STUDIES ARE NEEDED TO
BETTER UNDERSTAND BODY
COMPOSITION CHANGES WITH
GENDER-AFFIRMING THERAPY. IN
CROSS SECTIONAL SURVEYS COLLEGE
STUDENTS AND ADOLESCENTS ARE
MORE LIKELY TO REPORT POOR SLEEP
QUALITY. ADDITIONALLY SIMILAR
REPORTS REPORT FREQUENT EXERCISE
AND AVOIDANCE OF
GENDER-SEGREGATED ACTIVITIES.
FINALLY A SUBSTANTIAL RISK
FACTOR FOR PAH, WORTH NOTING AS
HI DISEASE, WITHIN THE GENERAL
POPULATION THE ADULT PREVALENCE
OF H.I.V. IS 0.4%, ACCORDINGS TO
THE CDC. EARLIER THE CDC
REPORTED 2% OF INCIDENT H.I.V.
CASES IN 2023 WERE IN
TRANSGENDER INDIVIDUALS.
DISPROPORTIONATELY AFFECTING THE
TRANSGENDER POPULATION. IN THE
CDC'S NHBS TRANSSAMPLE OF 1600
TRANSWOMEN LIVING IN SEVEN URBAN
CITIES WITH HIGH H.I.V. RATES,
44% OF WOMEN SURVEYED AND
SUBSEQUENTLY TESTED FOR H.I.V.
WERE POSITIVE. NEXT SLIDE,
PLEASE. PULMONARY CARE IN
TRANSGENDER PATIENTS IS AN OPEN
FIELD AND OPPORTUNITY FOR US. IN
THE DRAFTEST WAY THIS IS A
RETROSPECTIVE COHORT FROM THE
AMSTERDAM GENDER IDENTITY CLINIC
THAT INCLUDED OVER 2,900
TRANSGENDER WOMEN AND OVER 1,600
TRANSGENDER MEN. THE STUDY RAN
FROM 1972 TO 2018. THE MORTALITY
RATE FOR TRANSMEN WAS HIGHER
THAN EXPECTED FOR CISGENDER
WOMEN BUT NOT FOR CISGENDER MEN.
ON THE OTHER HAND, THE MORTALITY
RATE FOR TRANSWOMEN WAS
SIGNIFICANTLY HIGHER THAN
EXPECTED FOR THE POPULATION AS A
WHOLE.
TRANSGENDER WOMEN
EXPERIENCED HIGHER RATES OF
CAUSE-SPECIFIC MORTALITY FROM
CARDIOVASCULAR DISEASE, LUNG
CANCER, H.I.V. THERE ARE MORE
HIGHER RISK IN INDIVIDUAL AND
THE RISK FOR MORTALITY IS
VISIBLE IN TRANSGENDER WOMEN
WHEN WE COMPARE TO CISGENDER
WOMEN WITH A CARDIOVASCULAR
MORTALITY RATE THAT IS 2.6 TIMES
HIGHER. IN PATIENTS ON CROSS-SEX
THER
THERAPY LIPID STUDIES ARE THE
BEST METABOLIC VARIABLE.
HOWEVER, CHANGES IN LIPID
PROFILES VARY BASED ON WHETHER
THE PERSON IS ON M ASCULINIZING
OR FEMININE IZING. ALCOHOL,
DIET, SLEEP AND STRESS ARE
POORLY STUDIED. NEXT SLIDE,
PLEASE.
AS WE LOOK TO THE FUTURE OF
ADDRESSING DISPARITIES OF CARE
IN TRANSGENDER PATIENTS IT IS
IMPORTANT TO UNDERSTAND WHAT
LIMITATIONS OF CURRENT RESEARCH
ARE. SO FIRST MEASUREMENT OF
TRANSGENDER STATUS NEEDS TO BE
STANDARDIZED ACROSS HEALTH CARE
SYSTEMS AND RESEARCH PROTOCOLS
UTILIZING A TWO-STEP
IDENTIFICATION PROCESS TO
SEPARATELY IDENTIFY SEX ASSIGNED
AT BIRTH AND GENDER IDENTITY,
IMPROVED ACCURACY AND ALLOWS FOR
AFFIRMING CARE AND IMPROVED
RESEARCH QUALITY. SECOND RCTs TO
EXAMINE DOSAGE IN CROSS-SEX
HORMONE THERAPY WILL BENEFIT
TRANSGENDER PATIENTS TO ALLOW
FOR DOSING TO OPTIMAL EFFECT
WHILE MINIMALIZING EFFECT. THE
SCIENTIFIC COMMUNITY NEEDS TO
HAVE A CONVERSATION ABOUT CIS
NORMALATIVITY AND SEEK TO DEFINE
WHAT A APPROPRIATE CONTROL
POPULATION IS IN A TRANSGENDER
RESEARCH STUDY. NEXT SLIDE,
PLEASE.
WITHIN TRANSGENDER HEALTH
RESEARCH NONCOMMUNICABLE CHRONIC
DISEASE HAS ONLY BE GUN TO BE
INVESTIGATED. IN THIS 2024 META
ANALYSIS OF ARTICLES OF
TRANSGENDER HEALTH, ONLY 4%
EVALUATED RESPIRATORY HEALTH AND
ONLY 9% EVALUATED CARDIOVASCULAR
HEALTH. IN A QUICK SEARCH OF
CLINICALTRIALS.GOV I FOUND FIVE
RELATED TO CARDIOVASCULAR
DISEASE AND TRANSGENDER HEALTH
AND ONE REGISTERED TRIAL RELATED
TO PULMONARY FUNCTION AND
GENDER-AFFIRMING CARE. (BELL)
BECAUSE THERE SO LITTLE
KNOWLEDGE ABOUT THOUSAND BEST
CARE FOR TRANSGENDER PATIENTS
WITH PULMONARY HYPERTENSION I
WANTED TO THINK OF THIS IN A
STEPWISE APPROACH SO MY
RECOMMENDATIONS, I THINK THE
FIRST THING IS START WITH THE
BASICS. WE NEED A BETTER
UNDERSTANDING OF AN ANDOGENOUS
HORMONE S SO WE UNDERSTAND HOW
THEY MAY AFFECT DEVELOPMENT OF
CARDIOVASCULAR DISEASE. I THINK
GENDER CARE CLINICS AND LARGE
HEALTH CARE ORGANIZATIONS AS
WELL AS PH REGISTRIES NEED TO
WORK TO CREATE PRO SPE PROSPECT
COHORTS OF GCD PATIENTS AND THE
STATE OF HEALTH OF THE PATIENTS.
WITH E NEED TO DEFINE AND
UNDERSTAND THE BARRIERS TO CARE
THAT TGD PATIENTS ARE
EXPERIENCING. I HAVE LISTED HERE
A FEW OF MY PERCEPTIONS OF
BARRIERS TO CARE BUT THESE ARE
ONLY ASSUMPTIONS AND WORKING
UNDER ASSUMPTIONS DOESN'T HELP
OUR PATIENTS. WE NEED TO
EVALUATE RISK-ASSOCIATED
CONDITIONS AND HOW THOSE THINGS
MAY AFFECT THE HEALTH OF OUR
PATIENTS. AND FINALLY WE NEED TO
LOOK AT MINORITY STRESS AND HOW
DOES MINORITY STRESS INFLUENCE
THE RISK OF DEVELOPMENT OF
PULMONARY HYPERTENSION IN BINARY
AND NON-BINARY INDIVIDUALS. NEXT
SLIDE, PLEASE.
WITHIN THE SEX PARADOX AND
GENDER, WE NEED TO EVALUATE HOW
DOES THE CROSS-SEX HORMONE
THERAPY OUR PATIENTS ARE ON
ALTER THE RISK OF DEVELOPING
PAH. FOR INSTANCE, SPURNOLACTONE
IS USED AS ANTI ANDROGEN IN
TRANSWOMEN. DOES IT MITIGATE
EFFECTS OF TESTOSTERONE ON THE
RIGHT VENTRICLE IF USED BEFORE
THE DEVELOPMENT OF CLINICALLY
APPARENT DISEASE? IN PATIENTS
WITH RISK FACTORS FOR PULMONARY
HYPERTENSION, FOR INSTANCE A
TRANSWOMAN WITH H.I.V. SHOULD
PERIODIC SCREENING FOR PULMONARY
HYPERTENSION OCCUR.
FINALLY I WOULD REALLY LIKE
TO ADVOCATE FOR AN EFFORT TOWARD
IDENTIFYING A GENDER-NEUTRAL AND
BODY-COMPOSITION NEUTRAL
BIO MARKER. THESE ARE AFFECTED
BY ESTROGEN ANDROGENS AND WE
SHOULD IDENTIFY THE BRASS RING
OF BIOMARKERS NOT INFLUENCED BY
SEX BODY SIZE. NEXT SLIDE.
FOR PROGRESS IN OUR GENDER
AFFIRMING CARE, WE NEED TO
PROVIDE EDUCATION FOR HEALTH
CARE PROVIDERS TO ENSURE THAT
KNOWLEDGE GAPS ARE FILLED IN. WE
NEED TO FOLLOW THE PHILOSOPHY,
NOTHING ABOUT US WITHOUT US, AND
CREATE MINORITY INCLUSIVE
RESEARCH TEAMS. WHEN THOSE
TEAM S HAVE BEEN CREATED WHICH
WILL BY EXTENSION GENERATE
GENDER-EXCLUSIVE RESEARCH
QUESTIONS AND GOALS. NEXT SLIDE.
THANK YOU.
>> THANK YOU VERY MUCH, DR.
STRAH. THAT WAS EXCELLENT
PARTICULARLY SINCE YOU HAD TO
WING IT ON THE FLY THERE. THAT
IS ALWAYS A BIG STRESSER, BUT
YOU DID AN EXCELLENT JOB. YOU
BROUGHT UP SOME INTERESTING
CONCEPTS THAT I HADN'T THOUGHT
ABOUT WITH BNP, SPURNALACTONE,
THAT IS PERTINENT TO OUR
PRACTICE. ONE QUICK QUESTION I
HAD FOR YOU IS AS GROUPS ARE NOT
REPRESENTED IN OUR CLINICAL
TRIALS AT ALL EITHER, THAT IS
JUST A GUESS. I'M ASSUMING THAT
IS CORRECT. OF COURSE SEX IS A
MAJOR THING THAT WE LOOK AT.
GENDER NOT NECESSARILY. AND THEY
ARE CONFLATED. HOW WOULD YOU
APPROACH THAT ISSUE WITH
INCLUDING THIS GROUP FOR TRIALS.
WHAT IS THE MECHANISM FOR THAT?
>> I THINK THIS IS REALLY
IMPORTANT. SO THE PULMONARY
HYPERTENSION ASSOCIATION
REGISTRY IS THE FIRST REGISTRY
TO INCLUDE GENDER SEPARATELY
FROM SEX ASSIGNED AT BIRTH. ALL
OF OUR PRIOR REGISTRIES ONLY
INCLUDE SEX OR GENDER. THEY USE
THE TERM INTERCHANGEABLY.
>> RIGHT.
>> SO I THINK THE PULMONARY
HYPERTENSION REGISTRY HAS MADE A
REAL STEP FORWARD IN IDENTIFYING
SEX AND GENDER SEPARATELY. I
THINK, AS I MENTIONED, THIS
TWO-STEP IDENTIFICATION PROCESS
IS REALLY IMPORTANT IN
IDENTIFYING SEX ASSIGNED AT
BIRTH AND THEN SEPARATELY ADDING
TO EVERY REGISTRY GENDER AND NOT
UTILIZING TRANSGENDER AS A
GENDER. WE NEED MORE SPECIFIC
THAN THAT TRANSGENDER COMMA
FEMALE-TO-MALE, TRANSGENDER,
MALE-TO-FEMALE, TO VERY CLEARLY
IDENTIFY AND, FOR LACK OF A
BETTER WORD, CATEGORIZE OUR
PATIENTS. THEN WHEN WE HAVE
PATIENT WHO'S FALL IN THE
TRANSGENDER CATEGORIES, ASKING
ABOUT GENDER AFFIRMING HORMONE
THERAPY. THE AFFECT OF CROSS-SEX
HORMONE THERAPY INFLUENCES OUR
CONCEPTS AND PERCEPTIONS OF
DISEASE DEVELOPMENT. I THINK
THAT THE ONLY WAY TO LEARN MORE
ABOUT THIS IS TO ASK.
>> SO IF I'M HEARING YOU
CORRECTLY, THE TWO-STEP PROCESS
IS CLEAR BUT WHEN REPORTING
RESULTS FROM STUDIES, WE SHOULD
REPORT BY NOT ONLY SEX BUT
GENDER AND GENDER AS TO WHETHER
OR NOT THEY ARE ON HORMONE
THERAPY AS WELL. IS THAT WHAT
I'M GETTING -- ALL RIGHT.
>> YES.
>> ONE MORE THING. JUST TO
ORGANIZATIONAL STRUCTURE AND
MAKING SURE WE HAVE EVERYONE'S
SLIDES. IF ANY OF THE SPEAKERS
SENT A SLIDE DECK WITH MULTIPLE
VERSIONS OR VERSIONS THIS
MORNING, I WOULD ENCOURAGE YOU
TO EMAIL JACKIE AND MAKE SURE WE
HAVE THE CURRENTLY VERSION.
DIREC
DIRECTOR LEOPOLD, A QUESTION?
>> THANK YOU FOR THAT TERRIFIC
TALK. THIS IS SOMETHING THAT IS
SO INCREDIBLY NECESSARY FOR US
TO HEAR BECAUSE THIS IS
SOMETHING THAT WE DON'T THINK
ABOUT 90% OF THE TIME, IF NOT
MORE. I WANTED TO ASK LIKE IS
THERE SOMETHING WE SHOULD BE
DOING IN TERMS OF ADVOCACY? YOUR
COMMENT ABOUT NOTHING ABOUT US
WITHOUT OUT, HOW DO WE BRING
THIS TO THE FOREFRONT OF
CLINICAL TRIALS AND PH?
>> I THINK THAT IS AN EXCELLENT
QUESTION. I THINK THE -- I THINK
THE POLICE TO GO FIND OUT HOW WE
SHOULD BETTER APPROACH RESEARCH
AND HOW TO BE MORE INCLUSIVE IS
TO REACH OUT TO OUR ADVOCACY
GRO
GROUPS. AS AN EXAMPLE WHEN I WAS
DESIGNING MY OWN STUDY I WANTED
TO MAKE SURE I WAS BEING AS
INCLUSIVE AS POSSIBLE. SO I
REACHED OUT TO OUR GENDER CLINIC
AND OUR GENDER CLINIC CONNECTED
ME WITH A GENDER MINORITY
INDIVIDUAL WHO HAS A DEGREE IN
ADVOCACY. WE WENT THROUGH. HE
JOINED OUR RESEARCH TEAM. WE
TOOK ON THAT PHILOSOPHY, NOTHING
ABOUT US WITHOUT US. HE HAS
HELPED US IN RECRUITING, HE
HELPED US IN ENSURING THE
LANGUAGE APPROPRIATE. SO I THINK
THAT FINDING ADVOCATES WHO CARE
ABOUT ADDING PATIENTS TO YOUR
STUDY (BELL) ARE REALLY -- IS
PROBABLY STEP ONE.
>> YEP, I THINK THAT IS
IMPORTANT. LOOKS LIKE THERE IS A
COMMENT FROM DR. QUIT. IN PRR
YOU USED STANDARDIZED QUESTIONS
THAT WERE STANDARD 11 YEARS AGO
BUT HAVE EVOLVED. YOU HAVE A
PLAN FOR INEVITABLE CHANGES OF
HOW TO COLLECT THE DATA. THAT IS
GREAT.
>> BACK TO THAT, DR. KAIL, ARE
THOSE VARIABLE TO NON-FAR GROUPS
TO EMULATE THOSE?
>> ABSOLUTELY, IT IS A GREAT
QUESTION. I THINK -- ACTUALLY I
DON'T KNOW IF PVDOMICS USE THAT
QUESTION, I KNOW THEY USE THE
RACE, ETHNICITY QUESTIONS, I
BELIEVE --
>> NO, NO.
>> WE DIDN'T --
>> YEAH, BUT THOSE QUESTIONS ARE
PROBABLY NOW OUTDATED SO ANY OF
THESE STUDIES YOU NEED TO PLAN
FOR FUTURE, HOW TO HARMONIZE
DATA FOR LONG PERIODS OF TIME.
>> ALONG THOSE LINE, I DON'T
KNOW IF LEI IS AVAILABLE BUT
SHOULD NIH BE ADDING THIS TO THE
TABLES THAT WE ARE ALL FILLING
OUT, IF WE ARE FILLING OUT ABOUT
RACE AND ETHNICITY, MIGHT NOT
INCLUDE TRANSGENDER, GENDER, SEX
AND TRANSGENDER INDIVIDUALS.
>> I THINK THAT IS A GOOD
QUESTION. AFTER THIS WORKSHOP
THIS IS THE TOPIC THAT WE WILL
NEED TO DISCUSS. CURRENTLY WE
DON'T HAVE THAT ON OUR TABLE FOR
INCLUSION BUT THIS IS GOOD
DISCUSSION, EYE-OPENING FOR ME
TOO. I DIDN'T REALIZE THE
DIFFERENCE BETWEEN SEX AND
GENDER, NOW VERY CLEAR AND
TRANSGENDER ISSUE. THIS IS
SOMETHING WE WILL HAVE MORE
DISCUSSION AND WITH OUTSIDE
INVESTIGATOR SO THANK YOU.
>> ALL RIGHT. WITH THAT WE NEED
TO MOVE ON. THANKS TO THE TALK,
DR. STRAUL.
>> THANKS FOR INCLUDING ME.
>> THE NEXT IS DR. EGHBALI,
TALKING ABOUT DIFFERENCE ON
WORLD SYMPOSIUM GROUPS,
IMPLICATIONS FOR DIAGNOSIS,
TREATMENT AND CLINICAL OUTCOMES.
DR. EGHBALI.
>> THANK YOU SO MUCH FOR
INVITING ME. VERY HAPPY TO BE
HERE. MY TALK IS GOING TO BE A
BIT DIFFERENT. I'M A PHD
SCIENTIST WORKING MAINLY
PRE-CLINICAL AND TRANSLATIONAL
RESEARCH ANIMAL MODELS. NEXT,
PLEASE.
MY TALK I WILL TALK ABOUT
TRANSLATIONAL KNOWLEDGE IN
RESEARCH GROUPS, WE HAD SIX
HORMONES AND SIX CHROMOSOMES,
THEN LEAVE YOU FEW CLINICAL
TRIALS TARGETING ESTROGEN
SIGNALS AND HAVE RECOMMENDATIONS
AS TO HOW TO COMPREHENSIVELY
STUDY SEX DIFFERENCES FOR FUTURE
RESEARCH.
WE TALK ABOUT SEX IN THIS IS
UNKNOWN. THERE IS HIGHER KNOWN
INSTANCE OF PH IN WOMEN,
PARTICULARLY GROUP ONE. HERE YOU
SEE A RECENT TABLE FROM
PUBLICATION OF DR. EARNEST AND
COLLEAGUE (?) AS YOU SEE THEY
LOOK AT 750 PATIENTS FROM GROUP
ONE TO GROUP FIVE. 73% OF
PATIENTS ARE FEMALE. THE SAME
ARE ALSO HIGHER FEMALE OVERALL
IN GROUP TWO, THREE, FOUR EXCEPT
GROUP FIVE. THEN HIGHER
INCIDENCE IN WOMEN. WOMEN ARE
DIAGNOSED WITH PH IS KNOWN THEY
RESPOND BETTER TO THERAPY. HAVE
BETTER FUNCTION, WHICH
TRANSLATES TO HIGHER SURVIVAL IN
WOMAN. SO THEN WE LOOK AT
EXPERIMENTAL MODELS OF PH. YOU
SEE, MOST OF THE TIME THERE IS
CONFIDENT THAT THE FEMALES ARE
DOING BETTER OR MORE PROTECTED
OR ESTROGEN IS PROTECTIVE.
SOMETHING KNOWN AS SEX PARADOX
OR ESTROGEN PARADOX NPH. NEXT
SLIDE.
I'M GOING TO TALK ABOUT
GROUP ONE. PAH. HAD DIFFERENT
SUB TYPES, CONNECTIVE TISSUE,
ASSOCIATED PULMONARY
HYPERTENSION AND H.I.V. RELATED.
AGAIN THERE IS A NEW TABLE FROM
DR. VENTETUOLO AND MARCO, ALMOST
2,000 PATIENTS BUT 1,500 FEMALE,
500 ARE MALE. WHEN YOU LOOK AT
DIFFERENT SUBTITLES OF PAH, YOU
SEE MAJORITY OF THEM ARE STILL
WOMAN EXCEPT IN H.I.V. RELATED
(?). IT IS WELL ACCEPTED
INCIDENCE IS MORE COMMON IN
WOMAN. WE LOOK AT ANIMAL MODELS,
NEXT SLIDE, PLEASE.
THESE ARE CLASSICAL ANIMAL
MODELS USED BY INVESTIGATORS.
THE MODEL THAT WE PUT THE
ANIMALS IN HYPOXIA FOR TWO
WEEKS. ONE OF THE FIRST EARLY
ONES WAS FROM DR. (?) ALMOST 40
YEARS AGO SHOWING FEMALE SEX IS
PROTECTIVE IN HYPOXIA RAT MODEL
AND OVER ACTIVITY MAKES IT
WORSE. LATER THE DOCTOR SHOWED
ESTROGEN APPEARS IN THE HYPOXIA
IN MAY RATS. OTHER MODEL
EXTENSIVELY IS MTC MODEL THAT WE
JUST GAVE THIS TOXIN AND ONE IS
SUFFICIENT TO INDUCE PULMONARY
HYPERTENSION. SEVERAL GROUPS
INCLUDING MY LAB HAVE SHOWN
FEMALE SEX IS PROTECTIVE IN THE
MCT RAT MODEL AND OVER ACTIVITY
MAKE DISEASE WORSE.
ALSO THERE WAS A WORK ALMOST
40 YEARS AGO SHOWING WITH
ESTROGEN METABOLIZED IS ABLE TO
SLOW DOWN THE DISEASE IN MCT
MODEL. NEXT SLIDE. SINCE PH IS
NOT ALWAYS DIAGNOSED EARLY WE
DECIDED TO SEE IF ESTROGEN COULD
RESCUE PRE-EXISTING PAH. IN THE
MCT MODEL AND RESTART ESTROGEN
TREATMENT THREE WEEKS AFTER MCT,
NO TYPE OF DISEASES ALREADY
ESTABLISH ED IN THE ANIMAL. WE
SHOW ONLY TEN DAYS OF ESTROGEN
TREATMENT IS ABLE TO RESCUE
PRE-EXISTING DISEASES YOU SEE
FROM DISTOL IK PRESSURE AND (?).
WHAT WAS INTERESTING IS THAT WE
HAD ANOTHER GROUP THAT WE ONLY
TREATED THEM FOR TEN DAYS BUT
DIDN'T SACRIFICE THEM. KEPT THEM
FOR ANOTHER 12 DAYS TO SEE IF
PROTECTIVE ACTION OF ESTROGEN IS
GOING TO BE SUSTAINED. AS YOU
CAN SEE THE ESTROGEN CONTROL
GROUP WE SEE SIGNIFICANT
IMPROVEMENT IN PRESSURE AND THIS
IMPROVEMENT WAS THERE IN THE
ABSENCE (AUDIO DISRUPTION) AND
WE WANTED TO KNOW IF RECEPTOR.
THAT IS WHY THERE ARE TWO MAIN
RECEPTIONIST S RECEPTIONIST /* *
-- RECEPTORS AND COMPARE. THE
AGONISTS AND AS WE USE B AGONIST
IN GREEN BARS WE SEE THAT IS
ALMOST AS EFFECTIVE AS ESTROGEN.
WHEREAS ESTROGEN RECEPTOR FOR
AGONIST REALLY HAVE MUCH
PROTECTION TO OFFER. OUR
CONCLUSION WAS THAT THE
PROTECTIVE ACTION OF ESTROGEN IN
MTC MODEL WE USE IS TO ESTROGEN
RECEPTOR B. NEXT SLIDE. WE
PUBLISHED THIS IN JOURNAL IN
2011 AND THERE WAS EDITORIAL AND
HAPPY TO SEE THE IMAGE ON THE
COVER OF THE MAGAZINE. NEXT,
PLEASE. BUT NOT ONLY ESTROGEN,
ESTROGEN METABOLITES LIKE
2METOXY OR 2HYDROXY IS
PROTECTIVE. THIS IS CONVERTED TO
TESTOSTERONE AND WITH HELP OF
AROMATASE IS MAKING ESTROGEN
CONVERTED TO METABOLITES. THESE
ARE KNOWN AS GOOD METABOLITES.
THERE ARE MANY PEOPLE SHOWING
THESE TWO ARE PROTECTED IN PH,
WHEREAS ON THE RED 16HYPOXY IS
SHOWN (?). NEXT ONE, PLEASE. THE
OTHER MODEL WE HAVE EXTENSIVELY
USED IS HYPOXIA, THAT MODEL. IN
MANY WAYS IT IT MY MIK /* /* --
IT MIMICS AND WHEN THEY COMPARE
FEMALE TO MALE THEY HAVE BETTER
PERFORMANCE AND LOWER
INFLAMMATORY IN ARTERIES, LOWER
RV FIBROSIS AND BETTER SURVIVAL.
IN THE FOLLOW-UP WORK BY DR. TIM
LAMB AND (?) THEY ACTUALLY SHOW
THE MECHANISM THAT ESTROGEN IS
PROTECTIVE, ESTROGEN RECEPTOR
(?) TO SIGNALLING TO (?) POTENT
EFFECTECTOR. ANOTHER GROUP USING
THE SAME HYPOXIA RAT MODEL
SHOWING COMPLETELY OPPOSITE
RESULT THAT ACTUALLY INSTEAD OF
ACTIVATING ESTROGEN RECEPTOR
THEY SHOW INHIBITION OF RECEPTOR
HAD THERAPEUTIC EFFECT IN FEMALE
RATS AND USE OF THE ENZYME THAT
CONVERT TO ESTROGEN, SHOWN TO
THE PH DEVELOPMENT. NEXT SLIDE.
THERE ARE ALSO GENETICALLY
MODIFIED MICE THAT THEY SHOWED
THEY DON'T SUPPORT THE FEMALE
PROTECTION IN PH. MOST OF THIS
WORK HAS BEEN DONE BY DR.
MC LAIN. SHE USED PH MODEL USED
BY OVEREXPRESSION OF THIS IN
MICE. THEY SHOW ACTUALLY IN THIS
MODEL ONLY FEMALE MICE DEVELOP
PH. (?) ACTUALLY MAKES -- IN
FEMALES. THERE IS ANOTHER MODEL
INDUCED BY BINDING PROTEINS AND
SHOW DEVELOPMENT OF LESION ONLY
BEING SEEN IN FEMALE MICE. NEXT
SLIDE.
WE ALSO LOOK AT MODEL FEW
YEARS AGO BY FEEDING THE WILD
TYPE MICE WITH DIET RICH IN
OXIDIZED LIPI D. PUT THE DIET ON
THIS DIET THREE WEEKS AND
DEVELOP HYPERTENSION.
INTERESTINGLY IN THIS MODEL, AS
YOU CAN SEE IN PANEL C, WE
COMPARE MALE AND FEMALE. IN THIS
MODEL WE SEE ACTUALLY FEMALE
DEVELOP MORE SERIOUS
HYPERTENSION THAN ME AND PUBLISH
FOR PEOPLE INTERESTED TO LOOK AT
THIS MODEL. NEXT SLIDE. THEN
WHEN COMES TO PH GROUP 2, WHICH
IS THE PH SECOND TO HEART
DISEASE, THIS IS ACTUALLY THE
MOST COMMON TYPE OF PH, EITHER
SECONDARY TO HEART FAILURE WITH
(?) OR HEART FAILURE WITH
REDUCED EJECTION FRACTURE. WHEN
COMES TO PH SECONDARY TO HEART
FAILURE REDUCED EJECTION
FRACTION THERE ARE SEVERAL
CLINICAL TRIALS THAT THEY SHOW
MORE MALE TO FEMALE RATIO,
INDICATING A HIGHER OF GROUP 2.
THEN YOU LOOK AT THE PH
SUBPOENAING DARE TO HEART
FAILURE WITH PRESERVE EJECTION
FRACTION, THE RESULT IS QUITE
MIXED. THERE ARE SOME CLINICAL
TRIALS THEY SHOW HIGHER RATIOS.
WHEN COMES TO PH GROUP 2 THERE
IS NOT REALLY MANY ANIMAL
MODELS. THERE ARE A LOT OF
ANIMAL MODELS TO INDUCE, REDUCE
EJECTION FRACTION. THAT IS
USUALLY DONE BY CONSTRICTION BUT
NO ONE REALLY LOOKS AT PULMONARY
VASCULAR REMODELLING IN THESE
MICE. INSTEAD THERE IS A LOT OF
WORK THAT NEEDS TO BE DONE IN
THIS GROUP. NEXT SLIDE. THEN PH
GROUP THREE IS SECONDARY TO
CHRONIC LUNG DISEASE. THIS
REALLY DEPENDS. THERE ARE
REPORTS WHEN THEY LOOK AT THE
ENTIRE GROUP THREE THEY SHOW
THAT FEMALES WERE MOST
SUSCEPTIBLE MAINLY BECAUSE OF
MUCH HIGHER ABUNDANCE OF PULL
MOP NEAR HYPERTENSION ASSOCIATED
WITH AUTO IMMUNE PULMONARY
FIBROSIS IN WOMAN. BUT IF YOU
LOOK AT OTHER OTHER ETIOLOGIES,
THERE MAY BE MORE SUSCEPTIBLE IN
GROUP THREE, COPD IS HIGH NER
MEN DUE TO SMOKING. ALSO IN
IDIOPATHIC FIBROSIS MEN ARE MORE
PRONE TO BE AFFECTED THEN WOMEN.
AGAIN IN IDIOPATHIC PULMONARY
FIBROSIS REPORTED MALE SEX IS
RISK FACTOR FOR (?) DYSFUNCTION
EVEN A CRU ADJUSTING THE PRESSU
NEXT SLIDE.
THERE ARE NOT REPORTS TO
LOOK AT RULE OF ESTROGEN AND
RECEPTORS IN PH GROUP 3. THIS IS
ONE OF THE FEW STUDIES FOUND
THAT THEY LOOKING AT THIS IN
LUNG OF HEALTHY SUBJECTS, IN
PATIENTS WITH PH SECONDARY TO
IPF. ESTROGEN RECEPTOR
EXPRESSION WAS SIGNIFICANTLY
HIGHER IN PAH SUBJECTS COMPARED
TO GROUP 3 HYPERTENSION. NEXTED
SLIDE. ALSO WHEN COMES TO ANIMAL
MODELS, THERE ARE NOT MANY
ANIMAL MODELS COMPARING MALE AND
FEMALE. THERE IS A STUDY THAT
THEY INDUCE GROUP THREE
HYPERTENSION IN RATS BY (?) THAT
WORK WAS DONE BY (?) MANY YEARS
AGO. IN THIS ONE, AS RIGHT NOW
SEE, YOU CAN SEE SURVIVAL WHEN
THEY (?) THE RATS AND SEE THE
MORTALITY HAS INCREASED, EVIDENT
BY HIGHER SYSTOLIC PRESSURE AND
LONG, BUT WHEN TREAT WITH
ESTROGEN METABOLITE TO
METOXYESTRADIOL, SURVIVAL IS
INCREASED IN PRESSURE AND (?)
NEXT SLIDE. WE ALSO DECIDED TO
LOOK AT THE RULE OF SEX
CHROMO
CHROMOSOME. WE KNOW INDENSE IS
HIGHER IN FEMALE IN PAH. MAYBE
MAY THEY HAVE A PROTECTIVE
FACTOR. THEN LOOK AT ROLE IN
COLLABORATION WITH DR. ARNOLD AT
UCLA. DR. ARNOLD AND HIS
COLLEAGUE, THEY PIONEERED
SEVERAL MOUSE MODELS KNOWN AS
(?). THESE MICE HAVE BEEN USED
BY MANY INVESTIGATORS LOOKING AT
DIFFERENT TYPES OF DISEASE AND
HIGHLIGHTED BY THE NIH
DIRECTOR'S OFFICE. NEXT SLIDE.
IN THE (?) ON THE LEFT IT IS
INTERESTING YOU CAN HAVE A
FEMALE MICE WITH X, X OR XY
CHROMOSOME. THE REASON IS
BECAUSE THE SRY GENE THAT
DETERMINES THE PRESENCE OF
TESTES ARE REMOVED FROM THE Y
CHROMOSOME AND THOUGH MICE HAS
XY CHROMOSOME, SEEING NOT THERE
THEY DEVELOP OVARIES AND
CONSIDERED FEMALE. COULD ALSO
HAVE MICE WITH XX CHROMOSOME. IN
THIS CASE WHEN THEY PUT THIS ON
THE AUTOSOME THEN HAS X AND ONE
HAS THE GENE AND WHY THEY
DEVELOP TEST IT. THIS ALLOWS YOU
LOOK AT ROLE INDEPENDENT
DEPARTMENT OF THE GONAD AND SEX.
THE OTHER MOUSE MODEL, IN
THIS MICE YOU CAN TEST THE ROLE
OF SEX CHROMOSOME DOSAGE, 1X
VERSUS 2X. CAN HAVE A FEMALE
MICE WITH 1X OR 2X AND MALE WITH
1X OR 2X AND THEN LOOK TO SEE IF
THE DIFFERENCES THAT WE SEE IS
BECAUSE OF THE (?) OR BECAUSE OF
THE ABSENCE OR PRESENCE OF Y
CHROMOSOME. NEXT SLIDE.
PARAGR
ALMOST TEN YEARS AGO WE
LOOKED AT THESE MICE TO SEE THE
ROLE IN HYPERTENSION. WE UTILIZE
ALL THESE DOCTORS FOR (?) SEX
HORMONES. WE WAITED FOR A MONTH.
AFTER THAT WE PUT THESE MICE
EITHER IN AMOXIA OR HYPOXIA A
FEW WEEKS. AS YOU CAN SEE IN FGC
MICE THEY ALL LOOK THE SAME BUT
WHEN PUT IN HYPOXIA, THE MICE
THEY HAVE XX CHROMOSOME,
REGARDLESS IF THEY HAD TESTES OR
O
OVARIES THEY HAVE HIGH DISTOLIC
PRESSURE. IT DOESN'T MATTER HERE
IF THEY HAVE 1X OR 2X. THE MOUSE
WITH Y CHROMOSOME, THEY ARE
PROTECTED. NEXT SLIDE.
WE HAVE PUBLISHED THIS WORK
IN BLUE JOURNAL IN 2018 SHOWING
THE Y CHROMOSOME PLAYS ROLE IN
EXPERIMENT MEN HI POX IK
PULMONARY HYPERTENSION AND WE
USED ANALYSIS OF CHROMOSOME Y
GENE TO SEE WHAT GENES ON Y
CHROMOSOME ARE EXPRESSED BOTH IN
THE HEART AND IN THE LUNG. WE
FIND THERE ARE ONLY FOUR GENES
ON Y CHROMOSOME EXPRESSED IN
LUNGS OF THESE MICE.
INTERESTINGLY, THREE OF THEM ARE
ALSO EXPRESSED IN HUMAN LUNGS.
BUT WHAT IS MORE IMPORTANT IS
THAT WE SEE THESE THREE GENES
THAT ARE EXPRESSED IN HUMAN
LUNGS, WHEN THESE PEOPLE HAVE
PULMONARY HYPERTENSION THE
EXPRESS ARE DOMINATED IN
PULMONARY HYPERTENSION. NEXT,
PLEASE.
NEXT WHAT WE DID, WE WANTED
TO KNOW WHAT GENE ON Y
CHROMOSOME IS RESPONSIBLE FOR
THIS PROTECTION. SINCE THERE
WERE ONLY FOUR IT WAS VERY EASY.
WHAT WE DID, WE SILENCED ONE
GENE AT THE TIME. FIRST WE GOING
TO (?) ALL THE MICE. WE WAITED
30 DAYS. AFTER THAT WE PUT THEM
IN TAMOXIA OR HYPOXIA AND
SILENCED ONE AT A TIME BY SNRNA.
THE THREE ON THE TOP, WHEN WE
SILENCED THEM WE DIDN'T SEE
CHANGE IN RV SYSTOLIC PRESSURE
BUT AS SOON AS WE SILENCED UTY,
WE SEE THE Y CHROMOSOME
PROTECTION WAS GONE. AS YOU CAN
SEE, THERE WAS A HIGHER SYSTOLIC
PRESSURE AND WE REPEATED THIS
EXPERIMENT SEVERAL TIME. NEXT
SLIDE, PLEASE.
WHAT IS REALLY INTERESTING
IS WE IDENTIFY ON Y CHROMOSOME
BUT WHEN LOOK AT DIFFERENT
ANIMAL MODELS OF PULMONARY
HYPERTENSION, WE LOOK AT THE
HYPOXIA MODEL IN MICE WE SEE UTY
IS DOWN REGULATED IN HYPOXIA IN
MICE. SEE UTY EXPRESSION IN
LUNGS OF BOTH MCT AND (?)
HYPOXIA DOWN-REGULATED. WE SEE
UTY IS DOWNGRADED IN LUNGS OF
PATIENTS WITH PULMONARY
HYPERTENSION. NEXT SLIDE.
THE NEXT QUESTION WAS, WE
WANTED TO SEE WHAT ARE DOWN
STREAM EFFECT TOORS. THAT IS WHE
EXTEND LUNGS OF THE MICE, UT AND
WILD TYPE FOR R.N.A. SEQUENCING
AND IDENTIFY INFLATION AS
PATHWAY WAS ENRICHED. WE ALSO
ANTICIPATED WITH ALL ONLINE WITH
MALE AND FEMALE PH LUNGS AND
IDENTIFY TWO GENES, CXCL9 AND
10. THESE ARE TWO PRO
INFLAMMATORY CYTOKINES REGULATED
AS OF UT KNOCK-DOWN AND ALSO IN
FEMALE PATIENTS THAT THEY DON'T
HAVE UT PART. NEXT SLIDE.
NEXT WE WANTED TO SEE IF THE
INHIBITOR ACTIVITY OF CX9,
BETWEEN THE TWO, CAN WE USE THIS
AS PRO TEN SHALL THERAPY IN
FEMALES. IN THIS WE USED FEMALE
RATS, USED GONAD INTACTS AND
BOTH MODEL OF THIS AND HYPOXIA
AND STARTED TWO WEEKS AFTER USE
OF MCT AND THREE WEEKS AFTER
SUCHING WHEN WE KNOW DISEASE IS
STARTING TO ESTABLISH. NEXT
SLIDE.
WE ACTUALLY WERE QUITE
IMPRESSED TO SEE THIS SMALL
MOLECULE. LOOKING ACTIVITY OF 9
AND 10 WERE ABLE TO
SIGNIFICANTLY REDUCE THE MCT IN
BOTH, MCT AND HYPOXIA. YOU SEE
THE SYSTOLIC PRESSURE IS (?).
ALSO SEE PULMONARY INCREASE AND
SEE THE RV HYPITROPHY WAS
REVERSED. I REPEATED WORK AND
DON'T WANT TO GO INTO DETAILS
BUT THIS WAS PUBLISHED IN BLUE
JOURNAL TWO YEARS AGO. THERE WAS
A NICE EDITORIAL BY DR. STEFAN
CHANT AT U D TO EXPRESS
DIFFERENCES IN PULMONARY
HYPERTENSION. NEXT SLIDE.
NOW I'M GOING TO JUST REVIEW
A COUPLE OF CLINICAL TRIALS THAT
THEY ARE LOOKING AT, IF
TARGETING THE ESTROGEN ACTIVITY,
ESTROGEN RECEPTOR OR THEY LOOK
AT THE ESTROGEN BIOCENTIS
BLOCKING AND CAN USE AS TRIALS.
(BELL) NEXT.
MOST CLINICAL TRIALS DONE BY
DR. (?) SHOWN LOOKING AT THE (?)
ESTROGEN ANTAGONIST. IN THIS WAS
A CLINICAL TRIAL. IN THIS ONE
THEY ONLY SHOW THE LEVEL OF
SECRETING ESTROGEN REDUCED BUT
NO REAL SIGNIFICANT IMPROVEMENT
IN THIS CHANGE. THERE WAS
ANOTHER CLINICAL TRIAL, AND THIS
WAS BY DR. (?). IN SHORT JUST
THREE MONTHS, PUT THEM IN (?)
FOR JUST ONE PERIOD A DAY. HERE
THEY SHOW IT WAS SIGNIFICANTLY
REDUCED BUT THERE WAS NO REALLY
DIFFERENCE IN (?) BUT WHAT WAS
INTERESTING WAS (?).
THERE ARE OTHER CUT WITH
ERIC AUSTIN AND OTHER WITH DR.
(?) LOOKING AT (?) AND
TAMOXOFIN. SOME OF THESE ARE
FINISHED. WITH E CAN LOOK AT
DATA ON THE CLINICAL TRIAL BUT
STILL NOT PUBLISHED BUT LOOKING
-- DR. CABLE IS LOOKING AT
BIGGER STUDY, PATIENTS AMEND
WOMEN AND PUT THEM ON FOR SIX
MONTHS, UP TO ONE YEAR, LOOKING
AT SOME PRIMARY AND SECONDARY
AND THE CLINICAL TRIAL THEY SHOW
THIS AND IMPROVE THE TEST AND
NOT MUCH ON TAXI OR TEST AND
KNOW THE CLINICAL TRIALS ARE
STILL NOT PUBLISHED. THEN JUST
TO HAVE SOME RECOMMENDATION, THE
DIFFERENCES FOR FUTURE CONCERN.
NEXT. IT IS VERY IMPORTANT TO
HAVE A PROPER STUDY DESIGN TO
INTEGRATE AND INVESTIGATE THE
ROLE OF SEX CHROMOSOME AND
GONADAL HORMONES IN PRECLINICAL
MODELS. I'M PART OF A GROUP
INVITED BY ATS TO WRITE A
RESEARCH STATEMENT THAT WE ARE
CURRENTLY WORKING ON THAT. DR.
ARNOLD IS PART OF THE GROUP. WE
WANTED TO JUST WRITE SOME
RESEARCH STATEMENT AS A
GUIDELINE AS HOW TO ADDRESS SEX
AS A BIOLOGICAL VARIABLE IN
PRECLINICAL MODELS OF LUNG
DISEASE. AS YOU CAN SEE
SUMMARIZED IN THIS FLOWCHART, IF
THERE IS A SEX DIFFERENCE WE
WANT TO LOOK AT ROLE OF SEX
HORMONES AND SEX CHROMOSOME. ON
THE NEXT YOU SEE THE FIRST
OBVIOUSLY THING, THE EASY THING
TO DO TH IS GONADECTOMY AND ARE
PLACE HORMONE AND SEE WHICH SUB
TYPES IS THE TARGET. THEN
IDENTIFY THE DOWN STREAM EFFECTS
OF THIS. THEN WHEN WANT TO LOOK
AT SEX HORMONE THE MOUSE AND
MODEL VERY POWERFUL, YOU CAN
IDENTIFY IF IT IS X CHROMOSOME
OR Y. IF IT IS X OR Y, WHICH
GENE UNDER X OR Y. THEN YOU ALSO
WANT TO IDENTIFY THE DOWN STREAM
EFFECT OF THE SEX CHROMOSOME
GENE IN A SPECIFIC TEST SIMILAR
TO WHAT WE DID WHEN WE LOOK AT
THE RULE OF THE UTY BUT AT THE
END WE NEED TO BRING EVERYTHING
BACK TOGETHER, BOTH SEX HORMONE
AND CHROMOSOME AND LOOK AT THE
INTERACTION OF BOTH. NEXT SLIDE.
THIS IS A LARGE MULTI -CENTER
STUDY TOWARD CENTERS. FOR THE
FIRST TIME THEY ARE LEVERAGING
THE LARGEST PH BIOBANK, WE HAD
96 LUNGS VERSUS 52 CONTROLLED
LUNGS. WHAT WE DID WAS HAVE RNA,
GENE NETWORK AND FIND WHICH
MODULE AND IDENTIFY A GENE AND
FIND HAS PROTECTIVE WALL. NEXT
SLIDE. WHAT IS REALLY
INTERESTING, WE HAVE ALL THE
CLINICAL DATA FOR ALL THESE
SAMPLES. ALSO WE HAVE ALL THE
RAW DATA THAT YOU CAN USE WITH
THIS ACCESSION NUMBER. IN CASE
YOU ARE INTERESTED TO LOOK IN
ANY INTEREST, CONTACT ME OR DR.
JASON FOR THIS ANALYSIS. NEXT
SLIDE.
I JUST WANT TO THANK
EVERYONE IN MY LAB,
COLLABORATORS AT UCLA, JASON
LONG, DR. REDDY AND EVERYONE
FROM THE LAB. THANK YOU SO MUCH,
EVERYONE.
>> THANK YOU VERY MUCH FOR THAT
WONDERFUL TALK. WE ARE SHORT ON
TIME SO I'M GOING TO MOVE ON TO
OUR NEXT SPEAKER. AFTER THAT I
DO HAVE QUESTIONS FOR YOU, DR.
EGHBALI. SO EXCELLENT TALK, I
APPRECIATE YOUR INSIGHTS.
ALL RIGHT. MOVING ON, LET'S
GO TO OUR NEXT TALK, WHICH IS
DR. VENTETUOLO, WHICH IS
ASSOCIATE PROFESSOR AT BROWN.
SHE IS SPEAKING ON INTERVENTIONS
AND IMPLEMENTATION TO REMEDIATE
SEX-BASED DIFFERENCES IN
PULMONARY VASCULAR DISEASE.
>> THANK YOU SO MUCH. THANK YOU
FOR THE ORGANIZERS FOR PUTTING
ON THIS GREAT SYMPOSIUM. I HAVE
LEARNED A LOT AND LOOK FORWARD
TO CONTINUING TO LEARN. NEXT
SLIDE, PLEASE. SO I WILL START
WITH MY DISCLOSURE, PROBABLY THE
MOST RELEVANT, I'M FUNDED TO DO
WORK IN THIS AREA, THOUGH I'M
NOT GOING TO COVER A LOT OF WHAT
WE ARE FOCUSSING ON TODAY. I
ALSO WANT TO SAY THAT, YOU KNOW,
IN THINKING ABOUT DR. STRAH'S
PRESENTATION EARLIER, IT IS
IMPORTANT TO KIND OF RECOGNIZE
TO DATE MUCH OF WHAT HAS BEEN
PUBLISHED REFERS TO SEX AND
GENDER INTERCHANGEABLY. I
ACKNOWLEDGE THAT IS AN OVER
SIGHT OF MOST PUBLISHED
LITERATURE TO DATE AND WE ARE
REGARDING THIS MOSTLY AS A
BINARY PHENOMENON IN TERMS OF
GENDER, AS WELL AS BIOLOGICAL
SEX. THAT, OF COURSE, IS NOT THE
CASE. NEXT SLIDE, PLEASE. SO THE
OBJECTIVES ARE TO THINK ABOUT
HOW TO INTERVENE AND IMPLEMENT
SOME STRATEGIES TO REMEDIATE
SEX-BASED DIFFERENCES IN
PULMONARY VASCULAR DISEASES. I
WILL NOT HAVE A TON BUT I WOULD
FOCUS ON NUANCES WE KNOW
OBSERVED TO DATE AND THINK HOW
WE CAN PERSPECTIVELY DESIGN,
PARTICULARLY PATIENTS THAT HAVE
SEARCHED TO ADDRESS GAPS. WE
WILL TALK A LITTLE ABOUT
TRANSLATIONAL BARRIERS FROM
EXPERIMENTAL MODELS TO HUMAN
OBSERVATIONS. I'M GOING TO SPEND
A FEW MINUTES ON SEX
CHROMOSOMES, AS WE JUST HEARD
ABOUT FROM DR. EGHBALI, THEN
SPEND THE BULK OF THE TIME
TALKING ABOUT IMPACT OR THINKING
ABOUT THE IMPORTANCE OF RESEARCH
AT THE END HERE. NEXT SLIDE,
PLEASE. TO FOCUS ON
TRANSLATIONAL BARRIER, NEXT
SLIDE, PLEASE.
WHEN I FIRST STARTED
THINKING OF HOW TO RESOLVE
WHAT'S BEEN LABELED ESTROGEN
PARADOX OR PUZZLE OF
ARTERIAL HYPERTENSION, WE KNOW
THIS IN GROUPS 1, 2, 3,
PULMONARY HYPERTENSION, MANY
MORE FEMALES OR WOMEN WHO
DEVELOP DISEASE AND YET WOMEN
APPEAR TO HAVE PROTECTIVE RIGHT
VENTRICLES AND SURVIVE LONGER
THAN MEN WITH THE DISEASE. AT
THE TIME THERE ARE A NUMBER OF
ELEGANT STUDIES IN LITERATURE,
ONE OF WHICH IS BY DR. FAHA,
DEMONSTRATING WHEN WE OVARIAN
ACTIVATE FEMALES AND GIVE BACK
FIZZ LOGIC DOSES OF ESTROGEN
THEY DEVELOP LEVELS IN THE
LUNGS, POTENTIALLY EXPLAINING
WHY WOMEN WITH PH ARE MORE
SUSCEPTIBLE. USING SOME OF THE
SAME STRATEGIES A NUMBER OF LABS
HAVE SHOWN THAT THE RIGHT AND
LEFT VENTRICALS ARE PROTECT ED
WITH MORE CAPILLARY DENSITY AND
PRESERVED EXERCISE CAPACITY. SO
THIS TRANSLATES BROADLY TO
ESTROGEN BEING BAD FOR LUNG,
GOOD FOR THE HEART. WITH I HAVE
OTHERWISE EXPLAINED THE
DESPERATE EPIDEMIOLOGIC
OBSERVATIONS AND CAN MOVE ON.
YET WE ARE STILL HERE TALKING
ABOUT THIS TODAY. NEXT SLIDE.
WHAT ARE SOME PROBLEMS WITH
TRANSLATING EXPERIMENTAL MODELS
TO HUMAN DISEASE? FIRST IF THE
YOU LOOK ACROSS SEXUAL DID
MORPHISM, AND DR. EGHBALI
REFERRED TO SOME OF THIS, THE
RESULTS DEPEND ON EXPERIMENTAL
CONDITIONS AND LAB OF DOING THE
WORK. YOU CAN SHOW VARIABLE
EFFECTS OF ANIMALS AND AGE OF
ANIMALS YOU ARE STUDYING. THERE
IS WORK OUTSIDE PULMONARY
DISEASE WHICH SHOWS YOU CAN
ALTER RESULTS OF EXPERIMENTS
WHEN THE SEX OF THE ANIMAL
HANDLER CHANGES. NEXT. THINKING
ABOUT CROSSING THE DIVIDE TO
HUMAN, WE HAVE TO CONSIDER THESE
RESULTS WE SEE IN PRECLINICAL
MODELS. SEX HORMONE AND RECEPTOR
RELATIONSHIPS ARE INCREDIBLY
COMPLICATED. THERE ARE TISSUE
AND COMPARTMENT SPECIFIC EFFECTS
WE HAVE TO CONSIDER. UNTIL
RECENTLY WE HAVE HAD A LACK OF
TISSUE OR CELLS UNLESS WE ARE
STUDYING INDIVIDUALS WITH
N-STAGE DISEASE AT THE TIME OF
DEATH OR LUNG TRANSPLANT. WE
HAVE TO CONSIDER THE IMPACT OF
LIFE CYCLE CHANGES. THEN AS HAS
ALREADY BEEN MENTIONED THIS
CONCEPT OF INTERSECTION ALT HAS
NOT BEEN PUBLISHED IN THE
INTERSECTION OF CARDIOVASCULAR
DISEASE.
ONE REASON THIS MAY BE
IMPORTANT IN INTERPRETING
RESULTS COMES FROM WORK BY DR.
COX-FLARITY, PREVIOUSLY IN THE
GROUP, NOW AT INOVA. ANOTHER BY
DR. PRUDESCUE'S GROUP WHICH HAS
SHOWN IN COMMERCIAL CELL LINES
AND IN CASE OF DR. PRUDESCUE'S
LAB, THE PULMONARY AND EN
ENDOTHELIAL CELLS, WHEN WE LOOK
AT DONORS WITH BIOLOGICAL
DIFFERENCES THERE ARE
DIFFERENCES IN SEX. THINKING OF
COMBINING THESE INTO ONE
EXPERIMENTAL STRATEGY, THIS MAY
BECOME PROBLEMATIC. NEXT SLIDE.
THIS WE RUZ CEN WAS /* -- WAS
RECENTLY ADDRESSED IN A DOCUMENT
THAT CAME OUT AND ADVOCATED FOR
STANDARDIZED REPORTING OF AT
LEAST AGE AND BIOLOGICAL SEX OF
THE SAMPLES BEING USED AND P FOR
STUDY OF SEXUAL DIMORPHISM AND
METHODS. I WANT TO SPEND TIME
TALKING ABOUT SEX CHROMOSOMES
BECAUSE I THINK THIS IS AN
EMERGING AREA TO THINK HOW TO
TRANSLATE TO HUMANS. THIS WORK
HAS ALREADY BEEN HIGHLIGHTED.
THIS IS A BEAUTIFUL WORK BY DR.
EGHBALI AND UMAR THAT LEVERAGED
THIS MODEL TO REALLY TURN THE
FIELD'S ATTENTION TO WHAT ROLE
SEX CHROMOSOMES MAY BE HAVING IN
PREDILECTION AND OUTCOMES OF
PULMONARY DISEASE. NEXT SLIDE.
I ALSO WANTED TO DRAW
ATTENTION TO CONCEPT OF X
CHROMOSOME AND ACTIVATION, AN
EMERGING AREA STUDIED I THINK
MOST ROBUSTLY IN AUTO IMMUNITY
BUT IMPLICATIONS FOR PULMONARY
HYPERTENSION. FOR THOSE THAT MAY
NOT HAVE HEARD EXIST IS
LONG-CODING R.N.A. WHOSE JOB IS
TO ACTIVATE ONE X CHROMOSOME TO
MITIGATE CHAIN DOSAGE EFFECTS IN
FEMALES, EXIST IN MALES LEADING
TO AUTO IMMUNE PHENOMENA AND
REPROMOTES CELLS TO A DIFFERENT
PARADIGM AND CHARACTERIZE BIAS
IMMUNITIES, OBSERVED IN LUPUS
AND OTHER CONNECTIVE TISSUE
DISEASES AS WELL. NEXT SLIDE.
THERE TO DATE HAS BEEN VERY
LITTLE REPORTS IN
ARTERIAL HYPERTENSION. WE ARE
WORKING TO STUDY THIS MORE
ROBUSTLY NOW. I HEAR ONE PIECE
OF WORK BUT DR. PREDESCUE'S LAB
IN EFFORT TO ESTABLISH A MODEL,
TRANSGENIC FOR (?) BUT REPORTED
ON PRESENCE OF EXIST IN HUMAN
PAH LUNGS AT THE TIME OF
EX PLANTS AS COMPARED TO DONORS.
THERE APPEARS TO BE ENOUGH
REGULATION OF EXIST IN HUMAN
PAH. NEXT SLIDE.
WHEN WE THINK OF STUDYING
SEX CHROMOSOMES MORE ROBUSTLY,
PARTICULARLY IN HUMAN DISEASE,
WE CAN'T JUST STOP AT THE
CONCEPTS WE HAVE ALREADY HEARD
ABOUT TODAY. NOT ONLY DO WE HAVE
TO CONSIDER THE SEX CHROMOSOME
COMPLEMENTS AS WELL AS
CHROMOSOME GENE EXPRESSION BUT
HAVE TO THEN GO ON AND THINK
ABOUT EPIGENETIC REGULATION,
THERE ARE KNOWN GONAD ON D.N.A.
METHYL-CATION AND CONCEPT OF X
CHROMOSOME ESCAPE, EVIDENCE IN
CARDIOVASCULAR DISEASE ABOUT SEX
DIFFERENCES AND IMPRINTING DUE
TO PARENT OF ORIGIN. FINALLY
WITH ADVENT OF SINGLE-CELL SEAT
TE
TECHNOLOGIES GROUP S HAVE SHOWN,
PARTICULARLY IN THE HEART, THERE
ARE DIFFERENCES IN CELL
POPULATIONS. YOU CAN SEE HERE
TYPICALLY AN ENDOTHELIAL FIBER
BLAST WITH HIGH RELEVANCE TO
PULMONARY DISEASE. NEXT. I WOULD
ADVOCATE SEX CHROMOSOMES AND
HUMAN CARDIOVASCULAR DISEASE IS
UNDERSTUDIED AND WILL TAKE
NAT
INNOVATIVE APPROACHES IN HUMANS.
ACTUALLY ONE PAPER THAT
CAUGHT MY ATTENTION (AUDIO
DISRUPTION) DISEASES ARE AMONG
SOME WE WILL BE SPEAKING OF.
THIS IS A REPORT USING TWO LARGE
COHORT STUDIES THAT HAS
DEMONSTRATED THE PRESENCE OF A
SUPER NUMARY SEX CHROMOSOME
INCREASES RISK OF VTE EVENTS
BOTH IN MY CODE DATA SET AS WELL
AS U.K. BIOBANK. MAY BE
DIFFICULT TO TRANSLATE TO THE
RARE E DISEASES BUT EVIDENCE
THAT SOME FORMS OF PULMONARY
VASCULAR DISEASE RISK MAY BE
CHARACTERIZED BY SEX CHROMOSOME
ANIPLOYDY. NEXT.
I WANTED TO SWITCH GEARS AND
TALK ABOUT LIFE CYCLE CHANGES
AND PATIENT CENTER RESEARCH AND
PULMONARY VASCULAR DISEASE.
THINKING ABOUT OUR YOUNGEST
PATIENTS, IS FEMALE SEX A RISK
FACTOR FOR PAH IN CHILDREN? I
WOULD SAY UNTIL RECENTLY THIS
WASN'T CLEAR. BUT WITH EM M
EMERGING OF PEDIATRIC REGISTRIES
THE ANSWER IS PROBABLY NO. IF
YOU LOOK ACROSS FOUR REGISTRIES
ON THIS SLIDE, ON BALANCE, ABOUT
50% OF CHILDREN AFFECTED BY PAH
ARE FEMALE. ABOUT 50% ARE MALE.
NE
NEXT. YET IN LITERATURE THERE
ARE CASE REPORTS OF PUBERTY
ASSOCIATED WITH REGRESSION OF
PULMONARY VASCULAR DISEASE IN
MALE WHO WHEN DEVELOPED PUBERTY
HAD HIS PH RESOLVED. IN TALKING
TO SOME OF OUR PEDIATRIC
COLLEAGUES MY UNDERSTANDING IS
THEIR GENERAL FEELING IS THIS
TRANSITION IS A RISK TIME FOR
PATIENTS, ALTHOUGH THIS IS NOT,
TO MY KNOWLEDGE, BEEN ROBUSTLY
STUDIED TO DATE. NEXT. WE WANTED
TO FOCUS ON THE MENSTRUAL CYCLE
IN PULMONARY HYPERTENSION SINCE
WE KNOW THIS DISEASE AFFECTS
YOUNG WOMEN OF CHILD-BEARING
POTENTIAL. SO WE DESIGNED THIS
STUDY TO LOOK AT FLUCTUATION
OVER THE COURSE OF ONE-MONTH
PERIOD OF TIME. WE ENROLLED
SUBJECTS FIRST DAY OF MENSES AND
CAME FOR FOUR VISITS FIXED BY
ONE WEEK AND FOLLOWED MARKERS OF
THE BURDEN OVER FACES. AS
COMPARED TO CONTROLS
HIGHLIGHT ED IN BLUE, PAH
FEMALES HAD HIGHER LEVELS OF
CIRCULATING ESTRADIOL AND MORE
FLUCTUATIONS IN CONTROL
INDIVIDUALS AS COMPARED TO PAH
PATIENT, SUGGESTING THAT PERHAPS
THERE WAS AN EXOGENOUS SOURCE OF
ESTRADIOL FROM PULMONARY CAUSING
HIGHER LEVELS IN PAH WOMEN OR
FEMALES. PERHAPS MORE ENTERING
IS DIRECT ASSOCIATIONS WITH
MARKERS LIKE SIX-MINUTE WALK
DISTANCE, ANTI PROBE PMT AND
TAXI WAS PHASE-DEPENDENT SO
DEPENDING WHERE YOU WERE IN THE
MENTSRUAL CYCLE, MAY HAVE BEEN
FAVORABLE OR POSITIVE
ASSOCIATION BETWEEN YOUR PH
MARKERS OR UNFAVORABLE
ASSOCIATION WITH YOUR PAH
MARKERS. NEXT SLIDE.
JESSICA BADLUM AT UNIVERSITY
OF VERMONT TRIED TO CHARACTERIZE
THIS IN USPHSAR REGISTRY. THEY
ARE TO BE CREDITED WITH
COLLECTING DATA ABOUT
POTENTIALLY AN AN NUS /* /*
ANDOGENOUS INFORMATION,
BREASTFEEDING, MENOPAUSE, ET
CETERA. UNFORTUNATELY BECAUSE OF
THE WAY THE STUDY WAS DESIGNED
THERE WAS NO CONTROL POPULATION.
OF COURSE SOME ARE SUBJECT TO
RECALL BIAS, AS ARE A LOT OF
REGISTRY SURVEYS WE USE. THEY
FAIL TO SHOW CLEAR RELATIONSHIPS
BETWEEN SUB TYPES OF PH AND ANY
OF THESE ANDOGENOUS FLUCTUATIONS
OVER THE COURSE OF A
INDIVIDUAL'S LIFE.
SO WE ASKED WHETHER AGE
COULD BE AN IMPORTANT EFFECT
MODIFIER OF BASELINE HUMAN
DYNAMICS. IN THIS STUDY STEVE
KAYWOOD AND I USED INDIVIDUAL
PARTICIPANT DATA FROM A NUMBER
OF CLINICAL TRIALS SUBMITTED TO
THE FDA FOR DRUG APPROVAL IN
PAH. WHAT YOU WILL SEE IS AT
BASELINE MALES AS COMPARED TO
FEMALES TENDED TO HAVE HIGHER
PRESSURE, LOWER CARDIAC OUTPUT
AND HIGHER PULMONARY VASCULAR
ASSISTANCE ADJUSTED FOR RACE,
WEIGHT, HEIGHT IN STUDY THEY
PARTICIPATED. WHEN CAME TO MEAN
PRESSURE YOU CAN SEE YOUNGER
MALES HAD HIGHER MEAN COMPARED
TO FEMALES BUT THIS DIFFERENCE
AT TEN WAITED BY THE TIME MOST
U.S. FEMALES UNDERGO THE
MENOPAUSAL TRANSITION.
WHILE WE DON'T HAVE DATA ON
MENOPAUSE DATE IN THIS DATASET
WE SORT OF A ARGUED AGE IS AN
IMPORTANT CONSIDERATION WHEN
THINKING ABOUT SEXUAL DIMORPHISM
IN INDIVIDUALS WITH PULMONARY
VASCULAR DISEASE. NEXT SLIDE. WE
DID A FOLLOW-UP STUDY NOW
INCLUDING 18 RANDOMIZED TRIALS
AND ALMOST 7,000 PARTICIPANTS IN
THESE RANDOMIZED CLINICAL
TRIALS. WE WANTED TO LOOK
SPECIFICALLY AT THINGS LIKE AGE
AND BODY MASS INDEX AND WHETHER
THESE COULD IMPACT SOME OF THE
MAJOR SURROGATE OUTCOMES WE USE
IN CLINICAL TRIALS. HERE I'M
JUST SHOWING YOU RESULTS FOR
SIX-MINUTE WALK DISTANCE. AS YOU
CAN SEE ON THE LEFT PANEL THERE
WAS NO EFFECT BETWEEN AGE AND
SIX-MINUTE WALK DISTANCE WHEN WE
LOOKED AT INTERACTIONS BY SEX.
IN TERMS OF BMI FEMALES ARE
REPRESENTED IN RED AS COMPARED
TO MALES IN BLUE. YOU CAN SEE
THAT FEMALES IN PARTICULAR AS
BMI INCREASED HAD MUCH LOWER
SIX-MINUTE WALK DISTANCE. WE
FOUND FEMALES HAD LOWER
PRESSURE, MEAN PRESSURE AND
HIGHER CARDIAC INDEX AND THESE
OTHER FACTORS LIKE AGE AND BMI
REALLY HAD A GREATER IMPACT ON
THE MALE HEMAMATIC
RELATIONSHIPS, ALTOGETHER
SUGGESTING IF WE DON'T CONSIDER
SOME OF THESE KEY FACTORS WHEN
WE ANALYZE OUR CLINICAL TRIAL
RESULTS -- AND BY KEY FACTORS
AND ANALYSIS I MEAN EFFECT
MODIFICATION, WE COULD ACTUALLY
BE REACHING INCORRECT
CONCLUSIONS WITHOUT APPROPRIATE
-- THINKING ABOUT CAUSAL
INFERENCE AND HOW TO MODEL
EFFECT MODIFICATION. NEXT SLIDE.
SO THE IMPACT OF THINGS LIKE
AGE IN THE MENOPAUSAL TRANSITION
AS WELL AS ANTHROMETRICS GOT ME
THINKING ABOUT ADIPOSE STORES.
THIS IS A NICE REVIEW. FOR THOSE
OF YOU THAT DON'T SPEND TIME
THINKING ABOUT SEX HORMONES,
ADIPOSE TISSUE WITH AGE AND
MENOPAUSE IS ACTIVE SITE HORMONE
METABOLISM, AROMATISATION.
THERE'S BEEN WORK SUGGESTS
ADIPOSE STORES IMPACT WITH
IMPACT OF SEX HORMONES ON
PULMONARY REMODELLING AND THOSE
EFFECTS ARE SEX-SPECIFIC. NEXT.
THERE'S BEEN SEVERAL NICE
PUBLICATIONS TO DATE LOOKING AT
IN PARTICULAR THORACIC ADIPOSE
BY CT AND M RI AND RISK ON THE
LEFT IS NICE REPORT BY DR. AMANI
AND COLLEAGUES AT PENN
DEMONSTRATING RELATIONSHIP
BETWEEN VISCERAL ADIPOSE
CHARACTERIZED BY CT AND RISK OF
PH IN INDIVIDUALS UNDERGOING
LUNG TRANSPLANT EVALUATION WITH
PH OF ALL FORMS. ON THE RIGHT IS
RECENT PUBLICATION FROM
INVESTIGATORS IN CHINA WHO
LOOKED AT EPICARDIAL TISSUE
CHARACTERIZED BY MRI AROUND R
AND SHOWED A U-SHAPE IN CLINICAL
WORSENING AND EPE VOLUME. AT
EXTREMES INDIVIDUALS WITH PH
TENDED TO DO WORSE.
SO WE ARE INTERESTED IN
DOING DEEP ANTHROPOMETRIC WITH
PHENOTYPE AND ADIPOMETRIC TISSUE
AND BONE HEALTH, GOING FORWARD.
NEXT SLIDE.
WE HAVE TALKED A LITTLE
ABOUT NATURAL LIFE EVENTS, AN
DODGE NOWS EXPOSURE BUT WHAT
ABOUT OTHER EXPOSURES AND RISK
OF CARDIOVASCULAR DISEASE. DR.
BADLUM, AUSTIN AND COLLEAGUES
LOOK T AT THE VANDERBILT COHORT
AND LOOKED AT DURATION OF
CONTRACEPTION AND AN ANDOGENOUS
HORMONE THERAPY USE AND FOUND NO
DIFFERENCE IN TERMS OF SOME OF
THE EXOGENOUS HORMONE EXPOSURE
OVER SOME OF THE SUBGROUPS.
SOME YEARS AGO STEVE KAYWOOD
AND I PUBLISHED IN THE MESA RV
COHORT THAT THE USE OF HORMONE
THERAPY MODERATED THE EFFECT OF
CIRCULATING ESTRADIOL ON RV
PHENOTYPE. IN BLUE THE
RELATIONSHIPS BETWEEN
CIRCULATING ESTRADIOL AND RIGHT
EJECTION FRACTION THERE WAS NO
ASSOCIATIONS IN NON-HORMONE
THERAPY USERS, WHEREAS THOSE
INDIVIDUALS WHO HAD BEEN USING
HORMONE THERAPY AT TIME OF THE
MESA BASELINE WAS CONDUCTED HAD
A FAVORABLE ASSOCIATION BETWEEN
CIRCULATING LEVELS OF ESTRADIOL
AND RAVF. IN FACT, THERE'S BEEN
TWO REPORTS OF HORMONE
REPLACEMENT THERAPY IN
INDIVIDUALS WITH SYSTEMIC
SCLEROSIS AS IT BEING PROTECTIVE
AGAINST DEVELOPMENT OF PULMONARY
HYPERTENSION. ALTHOUGH I WOULD
SAY THIS IS ANECDOTAL AND NOT
CONTROLLED DATA. NEXT.
SO LASTLY IN THE LAST SORT
OF FEW MINUTES I WANTED TO TURN
BACK TO THIS CONCEPT OF INTER
SECTIONAL RESEARCH OBJECTIVES.
YOU HAVE SEEN THIS SCHEMATIC
ACKNOWLEDGING SEX AND GENDER ARE
NOT INTERCHANGEABLE. I THINK TWO
STUDIES I PARTICIPATED IN THAT
WERE REALLY ILLUSTRATIVE OF THIS
FACT WERE SOME OF THE WORK I DID
WITH INTEGRATIVE BEHAVIORAL
HEALTH COLLEAGUES TO LOOK AT
RATES OF SEXUAL DYSFUNCTION IN
INDIVIDUAL WHO'S IDENTIFY AS
WOMEN WHO PULMONARY
ARTERIAL HYPERTENSION AND NOTE
THEY HAVE HIGH RATES OF SEXUAL
DYSFUNCTION EVEN AFTER
ACCOUNTING FOR THINGS LIKE
ANXIETY AND DEPRESSION. WE
CONDUCTED INDEPTH INTERVIEWS IN
THESE INDIVIDUALS AND REALLY
WERE ABLE TO TIE THAT SEXUAL
DYSFUNCTION IS RELATE ED WITH
POOR QUALITY OF LIFE AND OUR PAH
THERAPIES MAY SPECIFICALLY
AFFECT THESE DOMAINS DIFFERENTLY
IN INDIVIDUAL WHO'S IDENTIFY AS
WOMEN VERSUS MEN. SO DURING
THESE INTERVIEWS THAT CAME OUT
THAT MANY WHO IDENTIFIED AS
WOMEN WERE DOING THINGS LIKE
TAKING OFF THEIR PROST PUMPS TO
ENGAGE IN SEXUAL INTERCOURSE
WHEREAS SOME OF THE BIOLOGICALLY
MALE (BELL) REPORTED USE OF
SODANOFIL HELPED IN THIS REGARD.
ON THE RIGHT, I DON'T MEAN
TO TALK ABOUT POLITICS BUT I'M
GOING TO MENTION THAT I THINK WE
ARE AT A CRITICAL POINT IN
REALLY HISTORY IN TERMS OF
LIMITING ACCESS TO REPRODUCTIVE
CARE ESPECIALLY FOR PAH
PATIENTS. AND REGIONS OF COUNTRY
WHERE THIS MAY MOST IMPACT OUR
PATIENTS ARE THOSE ALSO AT THE
GREATEST RISK FOR HEALTH CARE
DISPARITIES WITHOUT
COMPREHENSIVE PAH CARE AND AT
THE HIGHEST RISK OF HAVING
COMPLICATIONS RELATED TO
PREGNANCY. SO I THINK STUDYING
THESE THINGS AND HOW THEY FACTOR
INTO OUR PATIENT'S EVERYDAY
LIVE S IS GOING TO BE CRITICAL
GOING FORWARD. NEXT. AS I
MENTIONED I DON'T HAVE A LOT OF
SOLUTIONS OTHER THAN I THINK
THESE ARE ALL IMPORTANT FACTORS
WE NEED TO THINK ABOUT WHEN
TALKING ABOUT THIS LINE OF
INQUIRY. WE NEED TO CONSIDER
ROLE OF SEX CHROMOSOMES AND
OTHER THINGS THAT EXIST IN
ACTIVATION. WE NEED TO CONSIDER
SEX, GENDER, AGE, ADIPOSE,
ANTHRO METRICS, ENDOGENOUS AND
EX DODGE NOWS HORMONES, INTER
SECTIONALITY, THEN FINALLY
TRANSPARENT REPORTING OF
EVERYTHING SO WE CAN LEARN
TOGETHER GOING FORWARD. NEXT.
WITH THAT I'LL WRAP UP BY SAYING
I WANT TO THANK THE RESEARCH
PARTICIPANTS THAT ENGAGE IN OUR
HUMAN SUBJECTS RESEARCH. WITHOUT
THEM, THEIR CAREGIVERS, WE
WOULDN'T HAVE THE RESOURCE, AS
WELL AS MY COLLABORATORS AND
FUNDING SOURCES.
>> THANK YOU VERY MUCH, DR.
VENTETUOLO. EXCELLENT TALK
THERE. I HAVE QUITE A FEW
QUESTIONS. I'M SURE THE AUDIENCE
DOES AS WELL. WE HAVE ABOUT HALF
AN HOUR FOR DISCUSSION.
BEFORE WE MOVE ON I THINK
DR. MATHIA HAS JOINED US. I
WOULD LIVE TO GIVE HIM THE
OPPORTUNITY TO DO AN
INTRODUCTION.
>> HI, STEVE MATHIA. I'M AT
JOHNS HOPKINS AND THIS IS
UNDERLYING CONNECTIVE TISSUE
DISEASES IN PARTICULAR AND LOOK
FORWARD TO DISCUSSIONS TO TALK
ABOUT DISPARITIES AND
CARDIOVASCULAR DISEASE, THANK
YOU.
>> THANKS A LOT, STEVE. MY FIRST
QUESTION IS FOR DR. EGHBALI. MY
QUESTION IS, IS THERE A -- AN
EFFORT OR DO YOU KNOW OF ANY
DATA WITH REGARD TO PRE-CLINICAL
MODELS USING TRANSGENDER TYPE
APPROACHES? FOR EXAMPLE, GIVING
MALE -- BIOLOGICALLY MALE RATS
FEMALE HORMONES AND VICE VERSA?
>> THAT IS A VERY GOOD QUESTION.
I DON'T KNOW ABOUT THAT BUT IN
SOME OF OUR RATS WE WERE
TREATING WITH ESTROGEN TO SEE IF
ESTROGEN CAN REALLY PROTECT THE
ANIMAL. BUT THAT WAS FOR A VERY
SHORT TIME. TREATING THE MALE
RAT TEN DAYS WITH ESTROGEN, BOTH
MALE AND FEMALE, LOOKING TO SEE
IF THIS TREATMENT CAN REALLY
REVERSE THE DISEASE OR REDUCE
THE SEVERITY OF THE DISEASE.
YES, WE HAVE SEEN AND WE HAVE
DONE IN MY LAB. OTHER PEOPLE --
I KNOW H TREATING HIS MALE RATS
WITH ESTROGEN. BUT TO LOOK AT IT
THE WAY YOU ARE TALKING TODAY,
NO, I (?)
>> DO YOU THINK THERE SHOULD BE
MORE OF AN EFFORT DO THAT?
>> BECAUSE WHAT WE ARE DOING IS
JUST FOR A VERY SHORT TIME. I
THINK WHEN THESE PEOPLE ARE
GOING THROUGH TRANSGENDER AND
RECEIVE HORMONE, I THINK IT IS
FOR A VERY LONG TIME THEY
RECEIVE THESE. I THINK WHAT IS
ALSO VERY IMPORTANT FOR OUR
ANIMAL STUDIES WHEN WE TREAT
THEM WITH EXOGENOUS ESTROGEN OR
TESTOSTERONE WE HAVE TO BE
CAREFUL. WANT TO USE THE DOSE TO
ACHIEVE PHYSIOLOGICAL CHANGE.
SOMETHING LIKE ESTROGEN, IF YOU
USE A LONG TIME IN HIGH DOSE IT
CAN INDUCE TOMO OR BREAST CANCER
OR ENDOMETRIAL CANCER THAT. IS
WHY DOSE TO MAKE SURE LEVEL IS
AT THE PHYSIOLOGICAL RANGE AND
NOT VERY HIGH DOSE.
>> I'M NOT SURE WE ARE GOING TO
BE UNTANGLE GENDER IN
PRE-CLINICAL MODELS,
RESPECT FULLY. I WOULD JUST ADD
THAT I WAS INTERESTED IN TRYING
TO LEARN MORE ABOUT THIS
POTENTIAL EFFECTS ON THE CARDIO
PULMONARY SYSTEM IN THE
TRANSGENDER COMMUNITY. I
PARTNERED WITH COLLEAGUES HERE
WHO DO TRANSGENDER MEDICINE. I
THINK ONE OF THE THINGS I WAS
INTERESTED TO LEARN AND CURIOUS
ON DR. STRAH'S COMMENTS ABOUT
THIS, IS THAT WHEN INDIVIDUALS
UNDERGO TRANSITION, THERE IS NOT
ROUTINE CLINICAL PHENOTYPING
NECESSARILY THAT IS DONE WITH
RESPECT TO HEART OR LUNG
FUNCTION. I THINK THAT MAKES IT
POTENTIALLY MORE DIFFICULT TO
LEARN ABOUT LONGER TERM HEALTH
EFFECTS IN THESE PEOPLE.
>> YOU BRING UP A GREAT POINT. I
THINK THAT IS ONE OF THE THINGS
THAT IS A QUESTION. YOU KNOW, WE
ARE GUIDED THAT PATIENTS THAT
HAVE HISTORY OF THROMBOEMBOLIC
DISEASES THERE SHOULD BE
SCREENING. HOWEVER, IN PATIENTS
THAT HAVE RISK FACTORS SUCH AS
OBESITY AND INITIATING
TRANSITION, SHOULD THERE BE
CLINICAL PHENOTYPING OR IN
PATIENTS WHO HAVE H.I.V. SHOULD
THERE BE CLINICAL PHENOTYPING
PRIOR TO INITIATING. SHOULD BE
CLINICAL PHENOTYPING
PERIODICALLY AFTER INITIATING
GENDER-AFFIRMING HORMONE
THERAPY. I THINK THAT IS
SOMETHING WE DON'T KNOW YET. I
THINK THE OTHER QUESTION THAT
WILL BE RAISED IS IF WE START
CLINICAL PHENOTYPING EVENTUALLY,
THE COST-EFFECTIVENESS OF THAT
WILL COME INTO QUESTION SO I
THINK IT IS SOMETHING UNKNOWN.
ALTHOUGH A VERY INTERESTING
RESEARCH QUESTION.
>> I MEAN I WOULD ALSO ADD TOO
THERE IS GREAT WORK AND NOW VERY
OLD WORK FROM THE CLINIC AT BMC
SHOWING THAT BRACHIAL ARTERY
VASCULAR ACTIVITY, MARKER OF
VASCULAR HEALTH CHANGED
SIGNIFICANTLY BOTH IN MEN
TRANSITIONING TO WOMEN, WOMEN
TRANSITIONING TO MEN WITH
HORMONE THERAPY AND THEY WERE
ABLE TO DOCUMENT PRIOR TO
HORMONE ARE REPLACEMENT THERAPY
OR HORMONE THERAPY AND AFTER,
YOU KNOW, SEVERAL LONGITUDINAL
SESSIONS. THERE WERE REALLY
MARKED AND NOTABLE DIFFERENCES.
SO YOU EXTRAPOLATE WHAT YOU MAY
THINK IN THE PULMONARY
VASCULARATUR V, IT WOULD BE
SOMETHING INFORMATIVE. SO I JUST
WANT TO TALK A SECOND AND ASK
DR. VENTETUOLO, I'M REALLY
IMPRESSED BY THE STUDY YOU WERE
TALKING ABOUT WITH ENDOTHELIAL
CELLS, DIFFERENCES BETWEEN MALE
AND FEMALE PULMONARY CELLS, MADE
WE START THINKING DO WE KNOW
ANYTHING -- EVERYTHING WE HAVE
BEEN DOING IN VITRO IS NOW
WRONG?
>> I THINK, IN SHORT, JANE, IT
DEPENDS ON THE QUESTION THAT YOU
ARE ASKING. WE STARTED
DEVELOPING THIS TO EX TRANSIT
TRACT THESE FROM TIPS OF THE
CATHETER AND SOMEONE INTERESTED
I ASKED KATHERINE TO -- ARE
THERE DIFFERENCES IN COMMERCIAL
CELLS. I WAS ACTUALLY -- AS A
TRAINED TRIALIST AND
EPIDEMIOLOGIST I WAS SHOCKED TO
LEARN THAT NO ONE HAD PUBLISHED
THIS IN CELLS FROM THE PULMONARY
CIRCULATION. THERE IS BEEN A LOT
FROM OTHER SYSTEMS AND OTHER
ORGANS. I WAS SHOCKED TO LEARN
HOW DIFFICULT IT IS TO GET DONOR
INFORMATION FROM COMMERCIAL CELL
LINES. SO I THINK WE TALKED
ABOUT THIS, THE GROUP THAT PUT
OUT THIS ATS DOCUMENT. I THINK
IT DEPENDS WHAT YOU ARE
STUDYING. IF WHAT YOU ARE
STUDYING TO KNOWN TO POTENTIALLY
BE SEXUALLY DIMORPHIC I THINK
EVENTUALLY WE ARE GOING TO HAVE
TO SORT OF, YOU KNOW, THINK
ABOUT THOSE PHENOTIWIC
DIFFERENCES. WE DIDN'T TEST FOR
CELLULAR CARIOTYPE BUT THAT CAN
CHANGE IN A DYNAMIC PHENOMENON.
THE DEEPER YOU GO, SORT OF THE
DEEPER YOU GO.
>> YEAH.
>> THEN I GUESS COMPLETELY
UNRELATED, SO GIVEN EVERYTHING
WE HAVE BEEN TALKING ABOUT
HEESHGS SAY WE ARE DESIGNING A
NEW TRIAL AND WE WANT TO COLLECT
INFORMATION. WOMEN, GENDER, SEX,
HORMONE LEVELS, HORMONE
REPLACEMENT USE, ALL THAT. WHAT
DO WE NEED TO INCLUDE IN
QUESTIONNAIRES, WHAT KIND OF
INFORMATION DO WE NEED TO
COLLECT?
>> YEAH, I THINK THAT IS A GREAT
QUESTION. I THINK WE NEED TO
START WITH SOME OF THE THINGS
HIGHLIGHTED PREVIOUSLY SO
CERTAINLY BIOLOGICAL SEX AT
BIRTH. GENDER. WE, YOU KNOW, IN
OUR TRIAL OF DHEA, WE COLLECTED
A LOT MORE KIND OF DETAILED
HISTORICAL INFORMATION ABOUT
LIFETIME POTENTIAL ANDOGENOUS
AND ENDOGENOUS TO HORMONES. WHEN
YOU HAVE A TRIAL WHERE YOU ARE
MODULATING THINGS THAT ARE
HORMONES OR COULD DIRECTLY
IMPACT HORMONES THIS IS DATA
THAT IS IMPORTANT TO HAVE. EVEN
IN FACE OF NEGATIVE TRIAL IT IS
CRITICAL WE TRY TO LEARN
EVERYTHING WE CAN FROM THE DATA
WE COLLECT.
>> GREAT.
>> SO SORRY, CAN I ASK TECHNICAL
QUESTION TO DR. EGHBALI. MAY NOT
DIRECTLY RELATED TO THIS
WORKSHOP THEME BUT I'M VERY
INTERESTED IN -- YOU MENTIONED
YOUR ANIMAL MODEL THAT (?)
LIPIDS CAN CAUSE PULMONARY
HYPERTENSION. THIS IS SOMETHING
NEW. DID YOU SEE ANIMAL HAVE
SYSTEMIC HYPERTENSION OR UNIQUE
ONLY FOR THE CAUSE OF PULMONARY
HYPERTENSION?
>> YEAH, THAT IS A VERY GOOD
QUESTION. IN THIS ANIMAL MODEL
WE USED WILD TYPE MICE. WE PUT
THEM IN THIS DIET WHICH IS VERY
HIGH RICH IN THIS. THIS IS
INTERESTING IN THIS DIET FOR
THREE WEEKS WE ONLY SEE INCREASE
IN THE SYSTOLIC PRESSURE AND NOT
IN LV. THERE ARE OTHER MODELS
MORE PRONE TO DEVELOP ART
SCLEROSIS, LIKE DIFFERENT TYPE
MICE. WHEN WE PUT ON HIGH FAT
DIET THREE MONTHS ALSO DEVELOP
HYPERTENSION. DR. RABINICH
PUBLISHED MANY YEARS AND MY LAB
PUBLISHED ANOTHER WITH RECEPTOR
KNOCKOUT MICE. BUT WE PUT THEM
ON HIGH FAT DIET FOR THREE
MONTHS. EVERY WEEK WE DID AN
ECHO. WHAT WE FOUND WAS THAT WE
ACTUALLY SAW UP CREASE IN
SYSTOLIC PRESSURE BEFORE WE SAW
CHANGE IN LV. THAT IS WHY WE ARE
THINKING MAYBE THIS IS A GOOD
MODEL FOR GROUP 2. BUT GROUP 2
USUALLY WANTED TO HAVE (?) FIRST
AND DEVELOP HYPERTENSION AFTER
THAT. WHICH IS IN THIS MODEL WE
ACTUALLY SAW PULMONARY
HYPERTENSION PRECEDE THE LV
FAILURE.
>> YEAH, THAT IS VERY
INTERESTING. YEARS AGO I DO
STUDY ON THE LEFT HEART FAILURE
OR HYPE TROPHY. WE KNOW LIPID
CAN CAUSE HIGH TROPHY AND
FAILURE. WE THOUGHT BECAUSE OF
SYSTEMIC HYPERTENSION. THAT IS
WHY I'M ASKING QUESTION. YOUR
FIND ING IS REALLY INTERESTING.
IF IT IS UNIQUE TO PULMONARY
ARTERY SYSTEM THAT IS SOMETHINGS
FOR US TO LOOK INTO IT, THANK
YOU, THANK YOU.
>> DR. MARI MR /* MV -- DR. MAR
>> YOU ARE ON MUTE. STILL CAN'T
HEAR YOU, BRAD. BRAD, MAY YOU
DOUBLE-MUTED. YOU HAVE A DEVICE?
>> ON YOUR AUDIO, BRAD, CHECK TO
SEE IF YOU ARE USING THE CORRECT
DEVICE. SO WHERE IT SAYS AUDIO
CLICK ON THE LITTLE ARROW. SEE
IF YOU ARE USING THE CORRECT
DEVICE.
>> I WILL ASK A QUESTION WHY DR.
MARON IS WORKING ON HIS AUDIO.
DR. VENTETUOLO, I HAVE A
QUESTION. YOU MENTIONED SEVERAL
STUDIES. I DON'T KNOW WHAT TYPE
PH THEY WERE. ONE IN SQUARE
DERMA LOOKING AT HRT. WHICH IS
INTERESTING. DR. HEMNIS WILL BE
PRESENTING DAY WE HAVE BEEN
WORKING ON TOGETHER WITH PVOMICS
LOOKING AT PROTECTIVE EFFORT OF
HRT. IS THAT -- HAVE YOU LOOKED
FURTHER INTO THAT AND WHAT DO
YOU THINK IS GOING ON? IS THIS A
ESTROGEN EFFECT?
>> I THINK ONE OF THE CHALLENGES
WITH ALL HORMONE THERAPY
STUDIES, PARTICULARLY HORMONE
THERAPY STUDIES THAT WERE
CONDUCTED SORT OF EARLIER WHEN
WE WERE GIVING A LOT OF
INDIVIDUALS WHO WERE POST
MENOPAUSAL, PARTICULARLY OR LATE
PERIMEN PAUSE THERAPY, THEY
TENDED TO BE HEALTHY, AS OPPOSED
TO THOSE THAT AREN'T OFFER ED
THAT THERAPY. THOSE AT RISK FOR
CANCER OR CLOTTING, ET CETERA.
THP THIS DATA AND TWO REPORTS OF
SCLERADATA, IT COULD BE CON
FOUNDING. COULD BE IT HAS
PROTECTIVE EFFECT BECAUSE IT IS
A VASO DILATOR AND HAS CHANGES
MORE GENOMIC EFFECTS. I THINK WE
DON'T YET KNOW BUT OBSERVATIONS
ARE INTERESTING. ONE OF THE
THINGS I HOPE COMES FROM WORK
LIKE PVDOMICS IS WE UNDERSTAND
TEMPORAL RELATIONSHIPS AS WELL
AS STUDYING EFFECTS ACROSS ALL
TYPES OF PULMONARY VASCULAR
DISEASE TO SEE IF WE CAN
VALIDATE SMALLER SCALE
OBSERVATIONS.
>> GREAT, THANK YOU. DR. MARION,
ARE YOU WITH US?
>> CAN YOU HEAR ME?
>> THERE WE GO, GOTCHA.
>> SORRY ABOUT THAT. I HAVE A
NEW SYSTEM THAT I CLICKED OVER.
DR. STRAH, I WANTED TO ASK YOU A
QUESTION. I THOUGHT YOU GAVE A
GREAT PRESENTATION. I WAS ONCE
READING CARDIO PULMONARY
EXERCISE REFER TO 43 -YEAR-OLD
TRANSGENDER WOMAN TRANSITIONING
MALE TO FEMALE. THE QUESTION OF
HOW TO CALCULATE, HOW TO REPORT
WAS RAISED BECAUSE THIS
PARTICULAR PATIENT WAS IN
BETWEEN THE TRANSITION. SO THE
DISCUSSION WITH THE TRANSITION
AND SEX-AFFIRMING THERAPY THIS
PATIENT WAS ON SO BASED ON THAT
WE MADE A DECISION ABOUT WHAT
THE MOST APPROPRIATE DECISION
WAS TO STANDARDIZE RESULTS TO A
MALE OR TO A FEMALE HOP
ALLEGAT POP /*
-- POPULATION. SO THAT WAS
HELPFUL AND REAL WORLD
APPLICATION TO CONCEPTS YOU WERE
DISCUSSING. IN THAT SCENARIO
THERE WAS A NEED TO CALIBRATE
NORMATIVE VALUES FOR TRANSGENDER
PEOPLE. YOU HAD MENTIONED
INTERNAL PROBIANP TO ANOTHER
DIRECTION OF THE CONVERSATION,
WHICH I THINK IS GREAT. I GUESS
THE QUESTION HOW DO YOU KNOW
WHICH OF THE BIO MARKERS OR
PARAMETERS IN CARDIOVASCULAR IS
RIGHT. YOU CAN MAKE THE CASE FOR
PROBIA, IT IS SO SENSITIVE THAT
IT IS ELEVATED AND RECRAFTING
NORMATIVE VALUES MAY NOT BE AS
CLINICALLY IMPACTFUL AS PEAK
VOLUME OF OXYGEN CONSUMPTION,
WHICH IN MY LAB AND COULD EASILY
LAND IN MY LAB IF I'M READING
(?) FOR EXAMPLE. I THINK YOU ARE
EXACTLY RIGHT. I THINK THAT, YOU
KNOW, REESTABLISHING NORMATIVE
VALUES FOR THESE WOULD NOT BE
HELPFUL. IN STUDIES OF
TRANSGENDER INDIVIDUALS WHO HAD
CARDIAC EVENTS USING SEX
ASSIGNED AT BIRTH VERSUS
AFFIRMED GENDER REALLY DIDN'T
CHANGE OUTCOMES AND DIDN'T MOVE
PEOPLE FROM A DIAGNOSIS GROUP. I
THINK WHAT REALLY -- I GUESS MY
ASPIRATIONAL RECOMMENDATION
WOULD BE TO TRY TO REFOCUS ON A
DIFFERENT BIOMARKER THAT ISN'T
DEPENDENT ON GENDER OR BODY
HABITUS, FAT DISTRIBUTION, RENAL
FUNCTION, SOMETHING THAT IS
UNIVERSAL AND ACCESSIBLE TO OUR
ENTIRE POPULATION INDEPENDENT OF
GENDER, BE PEND INDEPENDENT /*
INDEPENDENT OF BMI.
>> I APPRECIATE THAT THAT, IS
HELPFUL.
>> I HAD A QUESTION FOR DR.
EGHBALI. SO MINORITY STRESS IS
SOMETHING THAT WE IN TRANSGENDER
HEALTH DISCUSS QUITE BIT. ONE OF
THE THINGS IS THAT IT IS
BELIEVED TO EXIST. IT IS HARD TO
STUDY. SO I'M WONDERING IS THERE
A WAY TO TAKE THIS BACK TO A
PRECLINICAL MODEL IN A WAY THAT
WOULD BE I GUESS FEASIBLE AND
SAFE FOR AN AN ANIMAL TO ASSESS
THE STRESS.
>> WHAT DO YOU MEAN BY MINORITY
STRESS? TO SEE HOW WE CAN MODEL
IT IN THE ANIMAL?
>> SO THE EXPERIENCE OF
DIFFERENT ENVIRONMENTAL
STRESSERS THAN THE, YOU KNOW,
HETERONORMATIVE, CISNORMATIVE
MAJORITY POPULATION. SO IS THERE
A WAY TO I GUESS CREATE AN
ENVIRONMENTAL STRESSOR IN A
PRE-CLINICAL MODEL?
>> IN ONE WHEN USING MICE OR
RATS, THEY NEVER LET US TO HAVE
A SINGLE CAKE BECAUSE THEY THINK
WILL CREATE A LOT OF STRESS FOR
THEM. THAT IS WHY WE ALWAYS HAVE
TO USE A GROUP OF THEM TOGETHER.
YOU KNOW, USUALLY YOU HAVE FOUR
OR FIVE PER CAGE. RATS ALWAYS,
DEPENDING ON THE SIZE, EITHER
TWO OR THREE IN THE SAME CAGE.
THEY NEVER LET US TO USE ANIMAL
INDIVIDUAL CAGE BECAUSE THEY
THINK IS GOING TO REALLY AFFECT
THEIR STRESS LEVEL. THAT IS ONE
THING. BUT ALSO WE SEE MORE AND
MORE ABOUT CIRCADIAN EFFORT. ONE
IS SOCIALIZING. THAT IS WHY WHEN
WE DO EXPERIMENT. ANOTHER REASON
WE NEED TO ALWAYS HAVE GROUP OF
ANIMALS TOGETHER. BECAUSE IT'S
BEEN ALSO SHOWN IF YOU DON'T PUT
A GROUP OF ANIMALS TOGETHER IT
IS GOING TO AFFECT THEIR
CIRCADIAN RHYTHM. THERE ARE
CERTAIN GENES THAT ARE SHOWN
THAT ARE REGULATED BY THE CLOCK
THAT ARE REGULATED BY ESTROGEN.
THE TALK TODAY IS REALLY
INTERESTING AND WE AS BASIC
SCIENTISTS NEED TO AGREE IN LAB
TO SEE HOW WE CAN ADDRESS THAT
EXPERIMENTALLY. NOW I REALLY
DON'T KNOW BEST WAY.
>> I LIKE THAT DR. GLEN WILL BE
TALKING ABOUT ALOSTAIC LOAD AND
THE SUBJECT YOU BROUGHT UP. SO
THAT IS SOMETHING -- ANOTHER
THING THAT IS INTERESTING AND
COMES TO MIND AND DR. VENTETUOLO
DISCUSSED THE INFLUENCE OF THE
HUMAN ANIMAL CAREGIVER, SEX OF
HUMAN ANIMAL CAREGIVER. I WONDER
IF THAT IS MORE OR LESS STRESS?
IT IS THE INTERESTING THAT THAT
IS A FACTOR. IF YOU HAVE
COMMENTS OR MAYBE AN
OBSERVATION.
>> YEAH, I DON'T KNOW THE
MECHANISM IS KNOWN BUT CERTAINLY
COULD BE.
>> I WILL COMMENT WITH THAT
BECAUSE I USED TO WORK WITH
ANIMAL BEFORE. AS DR. EGHBALI
WAS SAYING, NORMALLY PUT IN SAME
CAGE BUT ESPECIALLY FOR MICE YOU
CANNOT PUT DIFFERENT. MALE MICE
IN SAME CAGE. THEY WILL KILL
EACH OTHER UNLESS THEY ARE FROM
SAME LEADER, THEY GROW UP
TOGETHER, WHERE THEY WERE BORN.
SO THEY ARE OKAY. OTHERWISE IF
YOU PUT MALE MICE IN THE SAME
CAGE FROM DIFFERENT LITTERS,
THEY WILL EVENTUALLY KILL EACH
OTHER, ONLY ONE LEFT THAT. IS
TOTALLY DIFFERENT BEHAVIOR FROM
THE MODERN HUMAN BEING BEHAVIOR.
SO THAT IS MAKING IT DIFFICULT
FOR TO USE ANIMAL MODEL, AT
LEAST MALE MICE TO STUDY. FEMALE
YOU CAN PUT IN SAME CAGE THAT,
IS BETTER. BUT FOR MALE MICE
THAT IS PROBABLY COULD NOT BE
DONE. THAT IS MY CONCERN FROM
WHEN RUNNING MY LAB YEARS AGO.
>> THANKS, LEI. MAYBE SHOULD BE
MEASURING MARKERS OF ALOSTAIC
LOAD IN ANIMALS, JUST AS A
THOUGHT. AND DOCTOR --
>> SURE.
>> -- DR. DE-JESUS PEREZ, A
QUESTION?
>> THANKS FOR THE PRESENTATION.
I'M ACTUALLY EAGER TO HEAR MORE,
IF POSSIBLE, ABOUT THE RESULTS
OF THE PHANTOM STUDY, WHICH WAS
BROUGHT BY DR. EGHBALI. THIS WAS
A STUDY USING AN ASTROS TO
INHIBIT AROMATASE TO SHOW
SUPPRESSING ESTROGEN PRODUCTION
THAT COULD LEAD TO THERAPEUTIC
BENEFIT. I THINK IT IS RELEVANT
CONSIDERING THE PRESENTATION BY
DR. VENTETUOLO AND OTHERS
REGARDING HOW WE MEASURE THE
EFFECT OF ESTROGEN, ESTROGEN
METABOLITES. I THINK WE HAVE
COMPELLING EVIDENCE OF GOOD AND
BAD ORGAN DEPENDENCE OR
CELL-SPECIFIC SO AT THE END OF
THE DAY WILL BE INTERESTING TO
HEAR ULTIMATELY SINCE THE TRIAL
WAS COMPLETED A YEAR OR SOING A
IF THERE'S ANY RESULTS THAT
POINT OUT TO ULTIMATELY WHAT
HAPPENS WHEN YOU TARGET ESTROGEN
PRODUCTION.
>> DOCTOR KAWUT. DON'T WANT O
PUT HIM ON THE SPOT. I CAN FEEL
THE QUESTION.
>> YOUR NAME IS ALL OVER THOSE
STUDIES.
>> SORRY. GO AHEAD, COREY.
>> DESPITE A POSITIVE EARLY
PHASE 2 TRIAL OF 18 PARTICIPANTS
IN WHICH WE IMPROVED SIX-MINUTE
WALK DISTANCE IN INDIVIDUALS
GETTING AN ASTROSOL OVER SHORTER
PERIOD OF TIME THE FOLLOW-UP
PHANTOM STUDY, EIGHT-CENTER
CLINICAL TRIAL OF 84
PARTICIPANTS CONDUCTED DURING
COVID WAS ACTUALLY NEGATIVE.
THAT WAS PUBLISHED, WHEN STEVE,
LAST MONTH IN THE BLUE JOURNAL?
WHAT WE KNOW -- WELL, WHAT WE
SPECULATE IS THERE ARE
DIFFERENCES BETWEEN THE FIRST
AND SECOND TRIAL. ONE OF THOSE
DIFFERENCES, FOR EXAMPLE, IS WE
GAVE INDIVIDUALS -- GAVE ALL
INDIVIDUALS VITAMIN D
SUPPLEMENT
SUPPLEMENTATION, WHETHER THAT
BIAS POTENTIALLY CHANGED SOME OF
THESE PATHWAYS THAT INTERACT
WITH EACH OTHER, WE DON'T KNOW.
WE KNOW, HOWEVER, ONE OF THE BIG
QUESTIONS ABOUT REDUCING
ESTRADIOL IS WHETHER IT WOULD BE
SAFE FOR THE RIGHT VENTRICLE. AS
WE HAVE HEARD THERE IS CERTAINLY
DATA THAT SUGGESTS AS WELL AS
MESA STUDY IF YOU REDUCE E2 YOU
COULD HARM RV SO OUT TO A YEAR
WE HAVE ECHO-BASED PARAMETERS TO
SUGGEST WHILE WE DIDN'T DO MUCH
OF ANYTHING, WE DIDN'T HURT THE
RIGHT VENTRICLE. STEVEN, I DON'T
KNOW IF YOU HAVE OTHER COMMENTS.
>> I THINK YOU ANSWERED IT
NICELY.
>> ALL RIGHT. WITH THAT I'M
GOING TO -- BECAUSE DR. RACHEL
GOLD JUST JOINED US, I'M GOING
TO ALLOW HER TO INTRODUCE
HERSELF AS ONE OF OUR SPEAKERS.
HER TALK WILL BE AT THE END OF
THE NEXT SESSION. BUT SINCE
SHE'S JUST JOINED. RACHEL.
>> THANKS SO MUCH. I HAD A
MANDATORY MEETING AT MY
ORGANIZATION ALL MORNING IN
PORTLAND, OREGON. I'M A SENIOR
VIOLENTY TOR AT THE KAISER
PERMANENTE CENTER AND DIRECTOR
OF THE PROGRAMS AT -- SENIOR
INVESTIGATOR AT THE KAISER
PERMANENTE CENTER (CORRECTION)
AND WE HAVE A PRETTY RIGOROUS
RESEARCH ENDEAVOR GOING USING
THE DATA SET THAT IS (AUDIO
INTERRUPTION) SOCIOECONOMIC
DISPARITIES IN SAFETY NET
SETTING AND HOW TO IMPLEMENT
INTERVENTIONS TO THAT EFFECT. A
LOT OF EMPHASIS ON SOCIAL
DETERMINANTS OF HEALTH. THANKS
VERY MUCH FOR HAVING ME.
>> THANK YOU, DR. GOLD. I
ANTICIPATE THERE WILL BE A LOT
OF QUES
OF QUESTIONS. WE HAD MANY COME
IN THROUGH THE DISCUSSANTS HOW
TO STANDARDIZE. SO THAT (BELL)
>> GOT A GOOD SENSE OF THAT.
>> ANY OTHER QUESTIONS FOR OUR
PANEL HERE EITHER FROM
DISCUSSANTS OR OTHER SPEAKERS?
OKAY. WITH THAT WE HAVE A BREAK
FOR 15 MINUTES. WE WILL ADJOURN
AND COME BACK AT 3:15 EASTERN TIME.
HE WILL BE GIVING AN
OVERVIEW. WITH THAT DR.
BERNARDO.
>> THANK YOU FRANZ AND JAMES ON
ONE OF MY FAVORITE TOPIC,
RELATIONSHIP BETWEEN SOCIAL
DETERMINANTS OF HEALTH AND
CARDIOVASCULAR DISEASE. THESE
ARE MY DISCLOSURES. THE NEXT
SLIDE. I WILL BE GOING THROUGH
TERMINOLOGY THAT RELATES TO
SOCIAL DETERMINANTS OF HEALTH.
WE WILL BE TALKING ABOUT SOME OF
THE DATA THAT PERTAINS TO SOCIAL
DETERMINANTS OF HEALTH, SOCIAL
DEPRIVATION IN PATIENTS WITH
CARDIOVASCULAR DISEASE AND
HYPERTENSION. NEXT SLIDE,
PLEASE.
AS SPOKE EARLIER MOST OF
DATA WE USE FOR DECISION-MAKING
IN PAH COMES FROM LARGE TRIALS.
HOWEVER, THE REPRESENTATION OF
MINORS IN CLINICAL TRIALS IS
SIGNIFICANTLY MINIMAL. NEXT
SLIDE.
IN THIS NICE FIGURE WE CAN
SEE REPRESENTATION OF MINORITIES
IN DIFFERENT TRIALS BUT AS YOU
CAN SEE MOST CALLED REGISTRIES
ARE PREDOMINANTLY WHITE AND MY
SOME MINORITIES. (?) GROUP OF
INVESTIGATORS FROM AMERICAN
THORACIC SOCIETY HAD THIS
STATEMENT WHERE THEY WERE
PROVIDING SOME KEY
RECOMMENDATIONS WHEN COMES TO
RESEARCH RELATED TO HEALTH CARE
DISPARITIES AND WERE EMPHASIZING
SHOULD BE ABLE TO CAPTURE
INFORMATION RELATED TO RACE,
ETHNICITY AND SOCIOECONOMIC
STATUS OF PATIENTS AND SHOULD BE
INCLUDED SO WE CAN IDENTIFY
WHICH PATIENTS MAY BE AT GREATER
RISK FOR NONCOMPLIANCE. NEXT
SLIDE.
LET ME GO THROUGH SOME OF
THE DEFINITIONS. NEXT SLIDE.
HEALTHY PEOPLE 2030 IS A FEDERAL
INITIATIVE. IT IS VERY
INTERESTING. THE RATIONALE FOR
HEALTHY PEOPLE IS TO HAVE AN
IDEA OF GOALS OVER A DECADE THAT
HAVE TO BE PURSUED TO MAXIMIZE
THE WELL-BEING AND QUALITY OF
LIFE OF INDIVIDUALS. HEALTHY
PEOPLE HAVE DIFFERENT DOMAINS.
FOCUS ON HEALTH CARE EQUALITY,
HEALTH CARE DISPARITIESES AND
SOCIAL DETERMINANTS OF HEALTH.
NEXT SLIDE.
WHEN COMES TO SOCIAL
DETERMINANTS OF HEALTH THEY HAVE
FIVE DOMAINS THAT PERTAIN TO
ECONOMIC INSTABILITY. UNDER THE
ASSUMPTION THAT INDIVIDUALS WHO
HAVE A DIFFERENT INCOME TO
SATISFY THAT ARE BASIC NEEDS TO
STAY HEALTHY. BY STAYING HEALTHY
THATTING WITH BEING IS
PRESERVED. THE SECOND COMPONENT
OF SOCIAL DETERMINANTS OF HEALTH
COMES TO EDUCATION ACCESS. IT
GOES WITH A SIMILAR CONCEPT.
INDIVIDUALS WHO HAVE HIGH LEVELS
OF EDUCATION ARE MORE LIKELY TO
STAY HEALTHY. THERE IS A STRONG
DATA SUPPORTING THAT ASSUMPTION.
A THIRD COMPONENT IS EQUAL
ACCESS TO HEALTH CARE UNDER THE
ASSUMPTION, ONCE AGAIN, THAT
WHOEVER NEEDS ACCESS TO HEALTH
CARE CAN DO SO WITHOUT AFFECTING
THEIR FAMILIAR ECONOMY OR SO.
THE TWO NEXT THINGS THAT ARE
IMPORTANT IS SAFETY OF
ENVIRONMENT INDIVIDUALS GROW
WITH. THOSE ARE COMPONENTS OF
SOCIAL DETERMINANTS OF HEALTH.
NEXT SLIDE, PLEASE. WHEN WE TALK
ABOUT PAH (?) WE TALK ABOUT
INTER PLAY BETWEEN BIOLOGY AND
SOCIOECONOMIC FACTORS OF RACIAL
AND ECONOMIC FACTORS SO LET ME
TELL YOU ABOUT SOME OF THE DATA
WHEN COMES TO INTERPLAY BETWEEN
DISEASE AND SOME OF THE
SOCIOECONOMIC FACTORS. WHEN I
GIVE THIS TALK I REFER TO THIS
MAP. IT IS RELATIVELY OUTDATED.
WE DON'T HAVE UPDATED YET BUT
REFERS TO SEGREGATION. IT OCCURS
IN THE UNITED STATES. BY THAT I
MEAN PARTS OF U.S. WHERE
MINORITIES LIVE IN A DIFFERENT
PART OF TOWN, THE AREAS YOU SEE
IN PURPLE OR LILAC HAVE HIGH
INCIDENCE OF SEGREGATION AND
BLUE ARE WHERE COMMUNITIES
INTEGRATE VERY WELL. NEXT SLIDE.
SO WHEN COMES TO BALTIMORE,
WHERE SOME ARE LOCATED, DOWNTOWN
BALTIMORE IS HIGHLY SEGREGATED
AREA AND ACCOUNTS FOR MOST AREAS
IN THE UNITED STATES. THAT IS
IMPORTANT TO KEEP IN MIND. AS WE
TRY UNDERSTAND DIFFERENCES THAT
COME WITH A CONCEPT OF RACE OR
ETHNICITY, THOSE HAVE TO BE
ACCOUNTED FOR THIS LEVEL BECAUSE
WHEN THEY SEGREGATE, WHICH MOST
ARE. EXPOSURES ARE DIFFERENT. TO
POLLUTION, TO CRIME, TO ACCESS
TO HEALTHY OR -- WITH AMERICANS
WITH HEALTHY FOOD, THOSE
DIFFERENCES AFFECT QUALITY UNDER
WHICH TOGETHER. NEXT SLIDE. WHEN
WE TRY TO UNDERSTAND
DIFFERENCES, THEY RELATE NOT
JUST TO COLOR OF INDIVIDUAL BUT
RELATE TO DIFFERENCES ABOUT SEX
AND GENDER AS PRIOR SPEAKERS
EMPHASIZE ABOUT IT. THEY COME TO
DIFFERENCES ABOUT GENETICS AND
BIOLOGY OF SOCIOECONOMIC STATUS,
ENVIRONMENTAL EXPOSURES,
DIFFERENCES IN ACCESS TO HEALTH
CARE, TO EXPOSURE OF THE LEVEL
AND DIFFERENCES IN LIFESTYLE.
NEXT SLIDE.
ONCE AGAIN, WE HAVE FIVE
DOMAINS WHEN COMES TO SOCIAL
DETERMINANTS OF HEALTH. WE HAVE
EDUCATION, ACCESS TO HEALTH
CARE, SAFETY OF YOUR
NEIGHBORHOOD, THE SUPPORT
SUPPORT AND ECONOMIC STABILITY.
THE NEXT SLIDE.
NOT SO LONG AGO WITH (?)
NGOS FROM CINCINNATI WE TRY HAVE
DIFFERENT APPROACH, SOMETHING WE
REFER TO AS NOVEL SOCIAL
DETERMINANTS OF HEALTH, WHICH
HAVE CERTAIN VARIATIONS OF
CERTAIN SOCIAL DETERMINANTS OF
HEALTH THAT PERHAPS APPLY WITH
MORE PRECISION TO MINORITIES
WITH PROBLEMATIC HYPERTENSION.
AND SOME OF PRIOR SPEAKERS HAVE
REFERRED TO THIS BUT RELATED TO
DIFFERENCES IN ENVIRONMENTAL
EXPOSURE FOR INDIVIDUALS WHO ARE
(?) AND FACTORS THAT AFFECT
ACCESS TO HEALTH CARE RELATED TO
IMMIGRATION STATUS OR LANGUAGE
BARRIERS, DIFFERENCES IN HEALTH
CARE, DIFFERENCES IN MENTAL
HEALTH AND TRANSPORTATION AND
ALL THESE FACTORS COMBINED. ALL
COMPLEMENT EACH OTHER AND
CONSTITUTE OPTIMAL MEDICAL CARE
BARRIERS TO ENGAGEMENT CLINICAL
TRIALS PARTICIPATION,
DIFFERENCES ADHERENCE TO
TREATMENT AND DIFFERENCES IN
CONTINUITY OF CARE. THE NEXT
SLIDE.
LET ME TELL YOU ABOUT WHAT
WE KNOW ABOUT SOCIOECONOMICS AND
HYPERTENSION. BACK IN 2013, 12
YEARS AGO, STUDY ON 200 PATIENTS
FROM CHINA SHOWED THAT
INDIVIDUALS AT THE LOWER TILE OF
SOCIOECONOMIC STATUS HAS LOWER
AS COMPARED TO TWO OTHER
DETAILS. DIFFERENCES PERSISTED
EVEN IF YOU ARE JUST FOR OTHER
VARIABLES SUCH AS (AUDIO
INTERRUPTION) BACK IN 2016 A
STUDY FROM USING DATA FROM LARGE
HOSPITAL SYSTEM IN NEW YORK
FOUND INDIVIDUALS WITH THE
LOWEST ANNUAL INCOME WERE MORE
LIKELY TO PRESENT WITH MORE
SEVERE SYMPTOMS SO INDIVIDUALS
WITH LOWEST INCOMES, THEY WERE
MORE LIKELY TO PRESENT WITH
FUNCTIONAL CLASS 3 OR 4
SYMPTOMS. THE NEXT SLIDE.
HOWEVER, IN TWO STUDIES IN
EUROPE, PARTICULARLY SCOTLAND,
THESE PRIOR FAMILIES WERE (?)
DIFFERENCES IN SURVIVAL BASED ON
SOCIOECONOMIC STATUS WERE NOT
SEEN AND ALSO NO DIFFERENCES
WHEN COMES TO SEVERITY OF
SYMPTOMS THAT WERE FOUND. SO WE
HAVE SOME CONFLICT DATA. WE USE
DATA FROM THE HYPERTENSION
INDUSTRY TO NOTE THE
SIGNIFICANCE OF POVERTY AND
SOCIAL DEPRIVATION. WE USED DATA
FROM THE FOG. IT IS A GREAT
REGISTRY, AS MENTIONED BEFORE,
BECAUSE THE SYSTEM COLLECTS DATA
ON SOCIAL DETERMINANTS OF HEALTH
AND SOCIAL DEMOGRAPHICS. NEXT
SLIDE.
FOR THIS ANALYSIS WE ARE
USING THE ABSOLUTE DIFFERENCE.
FOR THOSE OF YOU NOT VERY
FAMILIAR WITH THE STANDARD OF
DIFFERENCES, ANY VALUE GREATER
THAN.25, THERE IS A DIFFERENCE
BETWEEN THOSE TWO GROUPS SO THE
VALUE OF THE ASD MORE THAN
LIKELY THERE IS A DIFFERENCE IN
THE TWO GROUPS. WHAT WE FIND IS
INDIVIDUALS IN POVERTY ARE LESS
LIKELY TO HAVE PRIVATE
INSURANCE, MORE LIKELY TO HAVE
MEDICAID. ARE INDIVIDUALS LIVING
UNDER FEDERAL POVERTY LEVELS ARE
MORE LIKELY TO BE UNEMPLOYED. WE
SEE ALSO INDIVIDUALS HAVE HIGHER
FREQUENCY OF REPORTED
METHAMPHETAMINE USE. WE SEE THAT
INDIVIDUALS LIVING UNDER FEDERAL
POVERTY LEVELS HAVE SUGGESTS
MORE SOCIAL DEPRIVATION WHETHER
THE SBA OR SOCIAL INDEX WHERE
HIGHER VALUES WERE FOUND
INDIVIDUALS LIVING UNDER POVERTY
LEVELS. THE NEXT SLIDE.
SOMETHING THAT WE WANTED TO
SPECIFICALLY STUDY IN THIS
ANALYSIS WAS TO SEE THAT OTHER
OF HEALTH CARE INDIVIDUALS IN
POVERTY OR NOT IN POVERTY. WHAT
WE FOUND, SIMILAR TO A STUDY I
WILL TELL YOU LATER TODAY, IS
INDIVIDUALS IN POVERTY ARE MORE
LIKELY TO GO TO THE EMERGENCY
ROOM OR GET HOSPITALIZED THAN
INDIVIDUALS NOT IN POVERTY. THE
NEXT SLIDE. WE DON'T SEE
DIFFERENCES IN SURVIVAL. THE
CURVE IS BETTER SORT OF POVERTY,
THIS DIFFERENCE IN CURVES BY THE
LONG-RUN DID NOT REACH A
STATISTICAL SIGNIFICANCE. THE
NEXT SLIDE.
WHEN WE USE DIFFERENT METRIC
OF SOCIAL PREVENTIONS SUCH AS
THE SOCIAL MOBILITY INDEX OR
FAMILY INCOME RATIO WE DO NOT
SEE THESE DIFFERENCES. SO
OVERALL WE SEE INDIVIDUALS
LIVING UNDER POVERTY LEVEL, EVEN
IF THEY HAVE A PATTERN OF
ILLNESS THEY HAVE HIGHER
FREQUENCIES OF GOING TO AN
EMERGENCY ROOM OR GETTING
HOSPITALIZED. THE NEXT SLIDE.
LET ME TELL YOU WHAT WE KNOW
BETWEEN RACE, ETHNICITY AND
SOCIOECONOMIC FACTORS. THE NEXT
SLIDE.
(?) REFERRED TO THIS STUDY,
A PAPER LED BY THE INDIANA
UNIVERSITY. IT IS A VERY ELEGANT
STUDY WHERE THEY USED DATA FROM
PAH BUT ALSO FROM (?) AND USE
DATA FROM UNIVERSITY (?) NEXT
SLIDE.
WHAT THEY FOUND IS HISPANIC
PATIENTS WITH PAH HAVE BETTER
SURVIVAL THAN NON-HISPANIC OR
NON-HISPANIC BLACK PATIENTS.
NEXT SLIDE.
SIMILAR PATTERN WAS SEEN BY
SANDEEP SAHAY FROM HOUSTON
METHODIST. NEXT SLIDE. IN THIS
SPECIFIC ANALYSIS IT WAS
HISPANIC INDIVIDUALS WILL HAVE
BETTER SURVIVAL OR DO IN THIS
MUCH LARGER STUDY USING DATA,
ONCE THEY ADJUSTED FOR AGE OF
INDIVIDUALS OR SUB TYPE OF PAH,
DIFFERENCES IN SURVIVOR WERE NO
LONGER SEEN. NEXT SLIDE. ALSO
MENTION THIS STUDY FROM PATIENTS
THAT BELONG TO TWO HOSPITAL
SYSTEMS WHICH ARE DUKE AND
CLEVELAND CLINIC, NEXT SLIDE.
IN THIS SPECIFIC STUDY THEY
SHOW THAT BLACK PATIENTS HAD
BETTER SURVIVAL THAN WHITE
INDIVIDUALS IN THE (?) ANALYSIS,
TAKING INTO ACCOUNT THE
INSURANCE OF INDIVIDUALS. THIS
DIFFERENCES DISAPPEARED, WHICH
LED TO HYPOTHESIZE THAT PERHAPS
ANY DIFFERENCE RELATED TO RACE
AND ETHNICITY HAS TO BE ACCO
ACCOUNTED. WITH THE STANFORD
GROUP AND STEVEN KAYWOOD WE USED
DATA FROM THE FAR A FEW YEARS
AGO AND WANTED TO ASSESS
DIFFERENCE IN SURVIVAL IN
HISPANIC PATIENTS WITH PAH BUT
WANTED TO CONDUCT THE SOCIAL
DEMOGRAPHIC AND PROFILE OF THE
PATIENTS AND TO KNOW WHAT WAS
THE SIGNIFICANCE OF SOCIAL
DETERMINANTS OF HEALTH WHEN
COMES TO SURVIVAL. THE NEXT
SLIDE.
WE FOUND, AND NOT SURPRISING
TO ANY OF YOU, THAT HISPANIC
INDIVIDUALS HAD LOWER INCOME
THAN NON-HISPANIC. AS YOU CAN
SEE, UP TO A THIRD OF PATIENTS
HAD ANNUAL INCOME OF LESS THAN
$20,000. NEXT SLIDE.
WHEN COMES TO SURVIVAL YOU
HAVE ADJUSTED ANALYSIS SO YOU
SEE THE HISPANIC INDIVIDUALS.
HOWEVER ON RIGHT YOU CAN SEE THE
ADJUSTED CURVE WHERE WE DO A
MULTI VARIABLE ANALYSIS FOR AGE,
SEX, (?) EDUCATION LEVEL, INCOME
AND HEALTH INSURANCE. AFTER WE
ADJUST FOR THIS VARIABLES WE DO
NOT SEE ANY DIFFERENCES IN
SURVIVAL. THIS LED US TO
HYPOTHESIZE THAT ALTHOUGH IT IS
POSSIBLE THAT FOR DIFFERENT
BIOLOGICAL REASONS THAT HISPANIC
PATIENTS COULD HAVE BETTER
SURVIVAL. THE SIGNIFICANCE OF
THIS BETTER SURVIVAL IS
MITIGATED IN THE PRESENCE OF
SOCIAL DISADVANTAGE. NEXT SLIDE.
NOW LET ME TELL YOU ABOUT
SOME OF THE GAPS IN KNOWLEDGE WE
HAVE. THE NEXT SLIDE.
I BELIEVE SEEING THE 2017-18
STATEMENT THERE HAS BEEN
IMPROVEMENT AND INCREMENT ON
PUBLICATIONS LED TO HEALTH
QUALITY IN PAH BUT MOST STUDIES
HAVE BEEN FOCUSSING ON THE
HISPANIC POPULATION, WHICH IS
IMPORTANT TO DO SO. HISPANIC
PATIENTS PERCENT LARGEST
MINORITY GROUP IN THE U.S. BUT
THERE IS SO MUCH MORE WE DON'T
KNOW ABOUT OTHER MINORITY GROUPS
SUCH AS BLACK PATIENTS, BLACK
AMERICANS, ASIAN AMERICANS AND
NATIVE AMERICAN PATIENTS WITH
PH. THERE IS MORE THAN WE NEED
TO KNOW ABOUT THE SIGNIFICANCE
OF OMICS IN MINORITIES. I
BELIEVE DATA FROM PVDOMICS WILL
BE USEFUL TO UNDERSTAND THAT. WE
NEED TO UNDERSTAND WHAT IS
SIGNIFICANCE OF DIFFERENCES IN
GEOGRAPHIC OR ENVIRONMENTAL
EXPOSURES. WE NEED TO KNOW MORE
ABOUT PH OUTSIDE U.S. AND
OUTSIDE OF EUROPE. I THINK WE
ALSO NEED TO KNOW MORE ABOUT
DIFFERENCES IN DEMOGRAPHICS OF
ALL FORMS, NOT JUST PH OR CTIF.
I WILL FINALIZE THAT SOCIAL
DETERMINANTS OF HEALTH IS JUST A
COMPONENT OF DIFFERENCES, ACCESS
TO CARE OR DIFFERENCES OF HEALTH
CARE EQUALITY. BUT PERHAPS WHAT
MATTERS THE MOST IS HOW
INDIVIDUALS RECEIVE THESE AT THE
INDIVIDUAL LEVEL, MEANING IN THE
PRESENCE OF SOCIAL DISADVANTAGE,
WHAT IS THE COMMUNITY EFFECT ON
GLOBAL STRESS. WHAT IS THE
SIGNIFICANCE OF THESE CHRONIC
AND MITIGATED STRESS AT THE
INDIVIDUAL LEVEL. THERE ARE
DIFFERENT WAYS THAT CAN BE DONE.
I BELIEVE ONE OF THESE WAYS TO
DO SO COULD BE THE ALOSTATIC
LOAD, REFERRING TO A MEASUREMENT
OF GLOBAL STRESS THAT IS
REFLECTED BY HYPERACTIVITY. YOUR
SYMPATHETIC SYSTEM. OUR GROUP
GOT FUNDED TO STUDY DIFFERENCE
OF ALOSTATIC LOADS IN HISPANIC
PATIENTS WITH PAH AND I'M VERY
MUCH LOOKING FORWARD TO HEAR THE
NEXT THREE PRESENTATIONS AND THE
PRESENTATION BY DR. JASON GLENN
TOMORROW. NEXT SLIDE.
AS A SUMMARY MINORITIES HAD
ANNUAL PERCENTAGE IN PAH
REGISTRIES IN CLINICAL TRIALS
AND RACE, ETHNICITY AND
SOCIOECONOMIC FACTORS NEED TO BE
CONSIDERED WHEN ASSESSING
INDIVIDUAL OF RISK AND HAS TO BE
MUCH MORE AWARENESS ABOUT WHAT
CAN WE DO AS A GLOBAL LEVEL.
NEXT SLIDE. THANK YOU TO MY
COLLABORATORS. I THINK WE CAN DO
A FEW QUESTIONS. NEXT SLIDE.
THANK YOU.
>> THANK YOU VERY MUCH, DR.
BERNARDO. THAT WAS EXCELLENT
OVERVIEW OF THE SOCIAL
DETERMINANTS, HOW THEY INTERACT
WITH HEALTH CARE DISPARITIES AND
PH. YOU BROUGHT UP ESSENTIALLY
SEVERAL STUDIES, INCLUDING YOUR
OWN WITH THE FAR, THAT LOOK AT
WHEN CONTROLLING -- OF COURSE
THIS IS PARTICULAR I THINK TO
THE HISPANIC POPULATION. YOU
ALLUDED TO SOMETHING WITH THE
BLACK POPULATION AS WELL. IN
MODELS, WHEN LOOKING AT
MULTI -VARIANT MODELS AND
CONTROLLING FOR SOCIOECONOMIC
DETERMINANTS YOU SEE SOME OF THE
RACIAL DISPARITIES ARE NOW
NON-SIGNIFICANT. IS THAT TRUE TO
YOUR RESULTS?
>> YES. ONE OF THE THINGS WE
NEED TO KEEP IN MIND, BASED ON
STUDIES WE HAVE DONE, IS WE ARE
USING DATA FROM THE FAR THAT
ALTHOUGH I CONSIDER IT THE BEST
REGISTRY TO UNDERSTAND BEST
REGISTRY TO UNITED STATES SOCIAL
DETERMINANTS OF HEALTH ARE
PATIENTS THAT RECEIVE FROM
CENTERS OF EXCELLENCE SO DATA
THAT MAY NOT NECESSARILY REFLECT
IN THE COMMUNITY OR HAVE MORE
DIFFICULTIES IN ACCESSING THESE
TYPE OF CENTERS. SO IT IS
POSSIBLE THAT WHAT WE DON'T FIND
DIFFERENCE IN SURVIVAL WHEN
COMES TO RACE, ETHNICITY AND
FEDERAL POVERTY LEVELS, PERHAPS
THAT IS DUE PATIENTS ARE FINALLY
GETTING STANDARD OF CARE FOR PAH
PATIENTS. COULD BE DIFFERENT
REALITY FOR PATIENTS THAT EITHER
ARE NOT GETTING DIAGNOSED YET OR
INSURANCES OR PROVIDERS DON'T
KNOW HOW TO MAKE PROPER WAY TO
SEND PATIENTS TO CENTERS OF MORE
EXPERIENCE IN PAH.
>> THAT IS A FAIR POINT. ONE OF
MY QUESTIONS TO YOU IS ASSUMING
THAT POTENTIALLY SOCIOECONOMIC
STATUS OR SOCIAL DETERMINANTS
ARE MEDIATORS OF RACIAL
DIFFERENCES OR ETHNIC
DIFFERENCES, STRUCTURAL RACISM
BEING AN PREACH TO STUDIES, OF
COURSE WHICH IS AN IMPORTANT
QUESTION AND THEREFORE IN THAT
CONTEXT PERHAPS IT IS USEFUL TO
INVESTIGATE RACE. BUT PERHAPS IS
IT EQUALLY OR PERHAPS MORE
IMPORTANT THAT WE IDENTIFY THE
SOCIAL DETERMINANTS AS MEDIATORS
OF THE OUTCOMES THAN NECESSARILY
DIVERTING OUR ATTENTION TO
CATEGORIZING SUBGROUPS WITHIN
RACE. DOES THAT MAKE SENSE?
>> ON THE TOPIC, I WAS READING A
MEDICAL YESTERDAY ABOUT
MEDIATION ANALYSIS ABOUT THE
MECHANISMS THAT DRIVE HEALTH
CARE INEQUALITY. WHILE SOCIAL
DETERMINANTS OF HEALTH MAY
EXPLAIN PARTIALLY SOME OF THE
DIFFERENCES, MEANING BARRIERS OF
INDIVIDUALS SAY IS TO GET PROPER
ACCESS TO HEALTH CARE, THERE ARE
OTHER COMPONENTS THAT CERTAINLY
MATTER PERHAPS THE SAME OR SOME
PERHAPS MORE SUCH AS ONE OF THE
SPEAKERS ALLUDED TO TODAY THAT
MICRO-TRAUMA, STRESS, SYSTEMIC
RACISM, DISCRIMINATION, THESE
OTHER FACTORS THAT PERHAPS
RELATED MORE TO HOW INTERVIEWER
PERCEIVES THESE BARE YERS AND
HOW ALL THESE FACTORS AFFECT
WELL-BEING OF AN INDIVIDUAL MAY
HAVE A HIGHER IMPACT INTO THEIR
DECISION AND HOW THEY ADAPT TO
THIS. PART OF THE REASON FOR THE
ALOSTATIC LOAD CONCEPT,
MEASURING MECHANISM DRIVING
HEALTH CARE AND EQUALITY IS
MEASURING MORE ABOUT THE GLOBAL
UNMITIGATED DISTRESS INDIVIDUALS
ARE FACING ON A DAILY BASIS.
THIS SIGNIFICANT STRESS THEY
FACE MAY PLAY A ROLE INTO HOW
THEY HAVE A MALADAPTIVE RESPONSE
TO A CERTAIN PHASE.
>> THANK YOU.
>> I WAS INTERESTED IN DATA YOU
WERE SHOWING, NO DIFFERENCES IN
TRANSPLANT-FREE SURVIVAL BETWEEN
DIFFERENT GROUPS WHEN LOOKING AT
SOME OF THE -- AFTER LOOKING AT
SOCIOECONOMIC FACTORS AND
LOOKING AT POVERTY, ET CETERA.
BUT IT RAISES THE QUESTION, IS
THAT THE WRONG METRIC TO LOOK AT
AND SHOULD WE BE LOOKING AT SOME
MORE LIKE -- MORBIDITY BURDEN?
SO THAT, YOU KNOW, IF --
REGARDLESS OF THE FACT THERE IS
NO DIFFERENCE IN TRANSPLANT-FREE
SURVIVAL, ARE THESE PATIENTS
LIVING THE SAME LIVES TO GET TO
THAT END POINT BEFORE -- FOR
THOSE THAT DON'T GET TO THAT END
POINT, I SHOULD SAY.
>> I WILL ANSWER THE QUESTION,
JANE. MAYBE A SIMILAR AMOUNT BUT
THE WAY THEY LIVE IS PROBABLY
MORE IMPAIRED. THE FACT THEY ARE
GOING TO THE EMERGENCY ROOM OR
GETTING HOSPITALIZED MORE
FREQUENT MAY SUGGEST THEIR
DEFICIENCIES ARE NOT PROPERLY
CONTROLLED. YES, THEY LIVE THE
SAME BUT THEIR QUALITY OF LIFE
MAYBE BE FURTHER IMPAIRED WITH
AT LEAST BASELINE. THEY HAVE
MORE IMPAIRED QUALITY OF LIFE
METRICS. BUT ALSO IT RAISES THE
QUESTION, WHY ARE THESE PATIENTS
GETTING HOSPITALIZED MORE
FREQUENT OR GOING O THE ER MORE
FREQUENT? IS THIS BECAUSE IS NOT
OPTIMALLY CONTROLLED OR BECAUSE
THEY ARE HAVING MORE BARRIERS OR
DIFFICULTIES FROM GETTING ACCESS
TO COME FROM PROVIDERS. BECAUSE
IDEALLY WHEN PATIENTS NEEDS
HAVING MORE SYMPTOMS OR SO, WE
EXPECT THEM TO CALL OUR CENTER
SO WE CAN PROVIDE SOME ADVICE OR
DO SOME TESTING OR ADJUST
MEDICATIONS TO PREVENT THEM FROM
HAVING TO GET TREATED. PERHAPS
MINORITIES ARE FACING BARRIERS
ABOUT THIS. INCLUDING PATIENTS
LIVING AT THE POVERTY LEVELS. WE
DON'T KNOW. I DON'T AGREE THAT
SURVIVAL MAY NOT BE THE BEST
METRIC TO ASSESS (BELL) A
SIGNIFICANCE OF HEALTH CARE
DISPARITIES.
>> HAS SOMEONE GONE BACK AND
SOMETHING SIMPLE LIKE
CALCULATING THE CHARLESTON
MORBIDITY INDEX TO SEE IF THERE
ARE DIFFERENCES DESPITE THE
(AUDIO INTERRUPTION) MAKES
SENSE.
>> DR. SANDEEP, QUESTION?
>> I WAS WONDERING ABOUT
SURVIVAL. THESE ARE MULTIPLE
STUDIES. ANALYSIS, YOUR FOREIGN
ANALYSIS AND I GUESS THERE WAS
ANOTHER PAPER. NONE ARE REALLY
SHOWING THAT RACE-BASED
DIFFERENCES IN THE SURVIVAL. BUT
I AGREE WITH YOU THAT ISSUES NOT
JUST THE SURVIVAL BUT THERE ARE
MULTIPLE ISSUES LIKE EARLIER
THIS MORNING THIS WAS ABOUT
INVOLVEMENT IN ENROLLMENT IN
TRIALS, ISSUES AND CLINICAL
TRIALS. SO THAT IS ONE ISSUE.
DON'T KNOW IF THERE IS DATA
ABOUT -- PARTICULARLY FOR
HOSPITALIZATION OR ANYTHING
BECAUSE IF YOU ARE LOOKING
PARTICULARLY AT HOSPITALIZATION,
THEN THEY KNOW THAT SHOULD --
SURVIVAL AS WELL. WE SHOULD SEE
SOME DIFFERENCE IN SURVIVAL. I
DON'T KNOW WHAT IS THE RIGHT
ANSWER. I GUESS WE NEED TO LOOK
BACK INTO THESE DATABASES AGAIN,
WHY WE ARE NOT SEEING THAT
SURVIVAL DIFFERENCES. DESPITE OF
IF WE ARE SAYING THAT
AFRICAN-AMERICAN, HISPANIC OR
MINORITIES ARE HAVING MORE
HOSPITALIZATION, ER VISITS OR IF
THESE ARE PH LETTER WHY NO
IMPACT ON SURVIVAL COMPARED TO
EFFECTS CONSIDERED AS
CONTROLLED.
>> THAT IS A GREAT QUESTION,
SANDEEP. I DON'T HAVE AN ANSWER.
>> I DON'T HAVE AN ANSWER
EITHER. BUT I DO BELIEVE THAT
THERE IS SOMETHING PROBABLY WE
ARE NOT LOOKING CLEARLY. I SEE
(?) IS ONLINE BECAUSE HE HAS
ANALYSIS FOR THAT. I KNOW ABOUT
IT. GO AHEAD. YOU TALK ABOUT
YOUR PAPER.
>> NO, NO, THAT IS OKAY. I LOVE
THE DISCUSSION. I THINK IT IS
REALLY IMPORTANT. I DON'T MEAN
TO CUT YOU GUYS OFF EITHER. I
THINK THAT SOMEONE WHO DOESN'T
DO MUCH CLINICAL RESEARCH, I
WILL HAVE TO DO SOME BASIC
TRAINING TO UNDERSTAND PRIMARY,
SECONDARY ENDPOINTS AND WHAT ARE
THE ENDPOINTS WE NEED TO LOOK AT
WHEN LOOKING AT POPULATION-LEVEL
STUDIES. ONE OF THE THINGS I
LEARNED IS MORTALITY IS ALMOST A
DREAM WHEN WE TALK ABOUT -- AS
AN ENDPOINT FOR CARDIOVASCULAR
DISEASE, ESPECIALLY IF YOU LOOK
AT THE CLINICAL TRIALS. WE NEVER
SAY MOST DRUGS LOOK ANYTHING
LIKE MORTALITY BECAUSE WE DON'T
HAVE THE POWER. THEN WHEN WE
TALK ABOUT MORTALITY IN A RARE
DISEASE IN A SUB POPULATION THAT
HAS BARELY BEEN REGISTERED, I
THINK WE HAVE TO BE VERY CAREFUL
ABOUT OUR CONCLUSIONS. ONE OF
THE THINGS I HAVE BEEN DINGED
FOR IN MY PAST HAS BEEN
OVERCORRECTING AND
OVERADJUSTING. IF YOU LOOK AT
YOUR SAMPLE POPULATION ACROSS
ALL THESE PAPERS, WE ARE TALKING
A SAMPLE SIZE OF 50 TO 150
HISPANIC PATIENTS, WHICH HOW
MANY ACTUALLY DIED. THEN WHEN
YOU TRY TO START ADDRESSING
VARIOUS VARIABLES THAT CORRECT
FOR MORTALITY, I THINK ANY
NEGATIVE OR POSITIVE DATA, YOU
HAVE TO BE A LITTLE CAREFUL
ABOUT WHAT THAT REALLY MEANS.
YOU KNOW, I DON'T WANT TO -- I
THINK IT IS ONE OF MY GAPS. I
THINK WE NEED TO DO A LOT MORE
STUDIES WHERE OUR SAMPLE SIZE
WILL HOPEFULLY EVOLVE AND GROW,
SO WE CAN LOOK AT SOME OF THESE.
THE UNADJUSTED REMAINS
DIFFERENT. DESPITE ALL THE
NOISE, DESPITE THE VARIOUS
COHORTS. SO, YOU KNOW, WE WILL
GO INTO MORE OF THIS DISCUSSION
TOMORROW. I WOULD SAY I DON'T
KNOW IF WE KNOW THE ANSWER BUT I
THINK THERE IS A LOT MORE HERE
THE DISCUSS. I'M REALLY GLAD WE
ARE HAVING THAT DISCUSSION.
>> I AGREE WITH YOU. BECAUSE IN
REVEAL ANALYSIS WHEN WE DID THE
SURVIVE, WHEN YOU LOOK AT THE
ORIGINAL PAPER FROM REVEAL, LED
BY FARBAR, THAT WAS SURVIVAL FOR
CAUCASIAN POPULATION. BUT OUR
ANALYSIS DID NOT. THE DIFFERENCE
WAS BECAUSE ADJUSTED FOR AGE AND
TYPE. JUST ONE MORE THING. WE
DID NOT FIND. BUT YOU ARE -- IF
YOU LOOK AT THE SAMPLE SIZE FOR
AGING POPULATION, IN THAT IT IS
LIKE 104 OR 150 PEOPLE.
CAUCASIAN WAS LIKE AROUND 2,500
AND AFRICAN-AMERICAN SAW LIKE
800. LITERALLY LESS THAN HALF.
REST ARE EVEN LESS THAN THAT.
PROBABLY NUMBER OF EVENTS ARE
MUCH LESS.
>> (?) YOU AND I HAVE SPOKE
BEFORE. EVEN IF WE DO A META
ANALYSIS, COMBINE THREE
REGISTRIES OR SO, THE FORMATION
BETWEEN REGISTRIES MAKES THESE
COMBINATION OF DIFFERENT
DATASETS DIFFICULT. BUT IN THE
ANALYSIS HISPANIC PATIENTS SEEM
TO HAVE BETTER SURVIVAL,
WHATEVER THE MECHANISM OR
WHATEVER WE ASSUME THAT IS.
>> I THINK ANKIT YOU BRING UP AN
INCREDIBLY IMPORTANT POINT. THIS
IS A GREAT DISCUSSION. I WANT TO
TABLE IT BECAUSE WE HAVE TO MOVE
ON. WE HAVE HAD SEVERAL
QUESTIONS ABOUT THE HISPANIC
PARADOX. ALSO I'M GOING TO COME
BACK TO THAT FROM THE
DISCUSSANTS. JUST TO SORT OF
REITERATE WHAT YOU ARE SAYING
AND IS -- I THINK IS INCREDIBLY
IMPORTANT WITH REGARD TO
ADJUSTMENT MODELS AND HOW THAT'S
-- I THINK WE SHOULD COME BACK
TO THAT POINT TOO ALSO. WE NEED
TO MOVE ON. SO LET'S MOVE ON TO
OUR NEXT TALK. IT IS ON SOCIAL
DISPARITIES, MENTAL HEALTH AND
RECREATIONAL DRUG USE BY DPEREZ
WHO DOES KNOW SOMETHING ABOUT
THIS. HE IS AT STANFORD,
ASSOCIATE DEAN OF ADMISSIONS AND
PROFESSOR OF MEDICINE. VENICIO.
>> THANK YOU. WE WILL TALK ABOUT
A LITTLE DIFFERENT OF THE TOPIC,
WHICH IS DRUGS. I REDEFINE TITLE
TO FOCUS ON SOCIAL DISPARITIES,
METHAMPHETAMINE USE. THAT IS
WHERE MY EXPERTISE LIES AND MOST
OF THE DATA I'M GOING SHARE WITH
YOU TODAY LIES. LET'S MOVE ON TO
THE NEXT SLIDE, PLEASE. I WILL
BEGIN AND END WITH THIS SLIDE.
THE EXPOSUM, A CONCEPT I WOULD
LIKE FOR US TO THINK ABOUT AND
HOPEFULLY INCORPORATE IN ALL THE
CONVERSATIONS MOVING FORWARD.
ESPECIALLY AFTER THIS WORKSHOP
BECAUSE IT INTEGRATES A LOT OF
WHAT WE HAVE BEEN DISCUSSING BUT
ALSO ADDS OTHER ELEMENTS THAT
ARE POTENTIAL MODIFIERS THAT
INFLUENCE HEALTH OF THE
POPULATION. WE HAVE BEEN TALKING
ABOUT SEX, WE HAVE BEEN TALKING
ABOUT SOCIAL DETERMINE NA
DETERMINANTS OF HEALTH. WE HAVE
SPOKEN FROM POLLUTION TO
POTENTIAL GEOGRAPHIC STRESSORS
RELATED TO THE WORK THAT THEY DO
RELATED TO THEIR -- EVEN BEFORE
THEY WERE BORN, RIGHT. SO
ULTIMATELY WE HAVE TO THINK OF
AN INDIVIDUAL IN THE SAME WAY WE
THINK ABOUT THE OMICS IN
PARTICULAR. FOR THIS COMPLEXITY
OF THE PATIENT, WE HAVE TO LOOK
ALSO AT THE COMPLEXITY OUTSIDE
OF THE PATIENT AS PART OF OUR
APPROACH. I'M GOING TO FOCUS ON
DRUGS BECAUSE THAT IS WHAT I
HAVE BEEN ASKED TO DISCUSS.
SINCE WE HAVEN'T TALKED ABOUT
THIS IN PARTICULAR I THINK IT IS
IMPORTANT SO WE CAN ACTUALLY
BROAD
BROAD -- BROADEN THE CONTEXT OF
WHAT WE HAVE BEEN TALKING ABOUT.
DRUGS ARE A PROBLEM AND FROM THE
SEVEN WORLD SYMPOSIUM AND
THERE'S QUITE A FEW DRUGS WE
HAVE COME TO RECOGNIZE, LIKE
AMENOREX, DEXT, FENFLOURAMINE
AND METHAMPHETAMINES. THESE
BELONG TO THE AMPHETAMINE
FAMILY. THIS IS WHAT I WANT TO
DEVOTE MY DISCUSSION. THIS
FAMILY OF DRUGS IS INTIMATELY
LINKED WITH PULMONARY
HYPERTENSION. UNLIKE THE OTHER
AGENTS IT IS PART OF THE
EVOLVING LANDSCAPE OF DRUG USE
IN THAT AMPHETAMINES HAVE
DEFINED THE 20TH CENTURY.
WHETHER IT IS WORLD WAR 1, WORLD
WAR II, PRESIDENTIAL
DECISIONS ABOUT THE CUBAN
MISSILE CRISIS, ART WORK,
AMPHETAMINES HAVE BEEN A BIG
PART. EVEN WHEN THEY ARE
OUTLAWED THEIR IMPACT REMAINS
UNSCATHED. IN FACT, WHAT WE ARE
SEEING NOW IS THE AFTERMATH OF
RECREATIONAL AND PRACTICAL
METHAMPHETAMINE USE THAT STARTED
EARLY IN THE 20TH CENTURY AND
SEE THAT SHOCK WAVE STILL TO
THIS DAY. NEXT SLIDE, PLEASE.
ALL RIGHT, SO WE ARE TALKING
ABOUT A GLOBAL PROBLEM. I WANT
TO START THERE BECAUSE IT IS
VERY EASY TO THINK THAT
AMPHETAMINE PROBLEM SAN AMERICAN
PROBLEM. IT IS NOT. TAKE A LOOK,
THIS IS 2021. THIS IS LEGAL AS
WELL AS ILLEGAL ABUSE. YOU ARE
NOT GOING TO SAY AS YOU SEE
CERTAINLY LEADS IN TERMS OF THE
GLOBAL PREVALENCE, BUT ACROSS
THE UNITED STATES -- THE WORLD
YOU CAN SEE THAT THERE ARE
CERTAIN FOLKS WHERE THE
PREVALENCE HAS EXPOUNDED. YOU
SEE THE CIRCLES EXPAND AS THE
RIPPLE EFFECT CONTINUES TO
EVOLVE. SO USE CONTINUES TO
INCREASE. IT DOESN'T REGRESS.
NEXT SLIDE, PLEASE. MY FOCUS ON
METHAMPHETAMINE, I HAVE BEEN
DEEPLY INVOLVED THERE THE CARE
OF THESE PATIENTS SINCE I
STARTED MY CAREER IN PULMONARY
CAREER AT STANFORD IN 2005. THIS
IS A TERRIBLE DISEASE.
METHAMPHETAMINE ADDICTION IS A
DISEASE. IT IS SOMETHING THAT IS
VERY DIFFICULT FOR THE PATIENT
TO KICK. IT REWRITES THE
COMPLETE LIFESTYLE OF THE
PATIENT AND ULTIMATELY, EVEN
THOUGH THE PATIENT IS LITERALLY
EXPERIENCES A COMPLETE
DEGRADATION OF MIND, BODY,
SPIRIT, THE PATIENT HAS A ROUGH
TIME KICKING THIS OUT. THIS IS
IMPORTANT, BECAUSE WHEN IT COMES
TO DEALING WITH THESE PATIENTS,
THEY ARE REALLY VULNERABLE TO
EVERY SINGLE SOCIAL DETERMINANT
YOU CAN THINK ABOUT. AND
ULTIMATELY, THEY ARE REALLY --
YOU KNOW, THEY ARE REALLY AT THE
MERCY OF THIS DRUG WHEN IT COMES
TO DEFINING THE AMOUNT OF
BENEFIT THAT WE CAN OFFER WITH
OUR INTERVENTIONS. NEXT SLIDE,
PLEASE.
I WANT YOU TO LOOK CAREFULLY
AT THIS DATA. PROBABLY THE MOST
IMPORTANT SLIDE I'M GOING TO
SHOW YOU TODAY. LET'S START WITH
THE RIGHT SIDE. THIS IS THE
TREND OF METHAMPHETAMINE
ADMISSIONS IN THE UNITED STATES.
2010, 2017. LITTLE BIT OUTDATED
BUT I THINK THE INFORMATION IS
QUITE CLEAR. FIRST UP, IF YOU
LOOK ON THE RIGHT SIDE, YOU CAN
SEE THE TRENDS. INDEED, THE
WEST, WHERE I WORK, IS WHERE THE
PREVALENCE HAS BEEN INCREASING.
BUT I WANT YOU ALSO SEE THAT
OVER THE LAST COUPLE OF YEARS,
DURING THIS TIME, ADMISSIONS FOR
METH USE IN MIDWEST AND THE
SOUTH HAVE INCREASED. MOVING TO
THE LEFT, WHEN WE LOOK AT THE
DIFFERENCE OF RACES, YOU WILL
SEE THAT, YES, THE WHITES HAVE
CERTAINLY BEEN (AUDIO
INTERRUPTION) HAVE INCREASED.
FOR BLACKS A SMALL INCREASE.
INTERESTINGLY ENOUGH AMERICAN
INDIAN S HAVE EXPERIENCED
REMARKABLE INCREASE IN THE RATE
OF ADMISSIONS, AS WELL AS
HISPANICS. WHEN COMES TO AGE
THEY CAN LOOK AT THAT. ALL AGE
GROUPS, BUT PARTICULARLY AGES
BETWEEN 25 AND 34, 35, 44, THESE
ARE YOUNG PATIENTS. THESE ARE
NOT YOUR TRADITIONAL IPH, AGE OF
55. YOUNG PATIENTS. I WANT TO
POINT OUT, WHICH IS CONCERNING,
AGES 12 TO 17 AND 55 AND OLDER
ALSO ARE SHOWING INCREASES IN
THE RATE OF HOSPITALIZATION. SO
THIS IS A REAL CONCERN. BECAUSE
WE ARE SEEING YOUNG PATIENT
WHO'S ARE ALREADY GETTING PRIMED
POTENTIALLY TO BECOME ADDICTS
AND POTENTIAL PH PATIENTS. LAST
BUT NOT LEAST BOTH SEXES, THE
RATE OF HOSPITALIZATION HAS
INCREASED. LOOK CAREFULLY WHEN
YOU HAVE THE TIME. BECAUSE THIS
SHOWS YOU THE RAW REALITY OF
WHAT WE ARE DEALING WITH WITH
METHAMPHETAMINE USE CURRENTLY.
NEXT SLIDE, PLEASE.
DRUG OVERDOSES, THIS IS ALSO
REVEALING. YOU CAN SEE YOU CAN
CUT THE UNITED STATES IN HALF.
THIS GOES IN HAND WITH THE DATA
REGARDING PREVALENCE OF PH IN
THE UNITED STATES BASED ON
FARVA. YOU CAN SEE HOW IT IS
DIVIDED BETWEEN FENTANYL AND
METHAMPHETAMINE OVERDOSES.
UNITED STATES, THIS IS PERFECTLY
CLEAR. WHAT I CAN ALSO TELL YOU
IS, AGAIN, THE EVOLUTION SHOWS
YOU THAT METHAMPHETAMINE IS
MAKING A SLOW BUT STEADY MOVE
TOWARDS THE EAST. BUT KEEP THIS
IN MIND. METHAMPHETAMINE IS
ACTIVELY INVOLVED IN MANY
DEATHS. I MEAN THE DEVASTATION.
WHY IS THAT? IT IS NOT JUST PAH.
NEXT SLIDE, PLEASE.
THE PROBLEM HERE IS THAT
METHAMPHETAMINE IS PART OF A
ADDICTION CYCLE. THIS ADDICTION
CYCLE IS DOMINATED BY SOCIAL
DETERMINANTS THAT FAVOR THE
PATIENT ENGAGING AND IN THIS
DISEASE, SUCH AS DOMESTIC
VIOLENCE, FACTORS WE HAVE
DISCUSSED, LACK OF FAMILY
SUPPORT, WHERE THE PATIENT IS
LIVING, IMMIGRATION STATUS,
SOCIAL INJUSTICE, HOUSING,
SCHOOL, ACADEMIC FAILURE. IN
THIS DAY AND AGE WHEN
IMMIGRATION AND SOCIAL INJUSTICE
ARE SUCH A IMPORTANT PART OF OUR
POLITICAL JARGON YOU CAN IMAGINE
HOW VULNERABLE SOME INDIVIDUALS
ARE CURRENTLY TO ENTERING THIS
ONE THING THAT WE HAVEN'T
DISCUSSED AND HAS HAD A
REMARKABLE IMPACT IN OUR CULTURE
AND OUR PATIENT POPULATION IS
THE PANDEMIC.
THE PANDEMIC WAS A TIME OF GREAT
STRESS TO PEOPLE, AND IT
CERTAINLY PUSHED A LOT OF PEOPLE
INTO ADDICTION, PARTICULARLY
METH ADDICTION, WE SAW AN UPTICK
IN THE NUMBER OF PATIENTS THAT
STARTED USING METH AND PATIENTS
WHO WERE FORMER METH USERS WENT
BACK TO IT TO DEAL WITH THE
STRESS.
SO THIS KIND OF EVENTS ALSO HAS
TO BE TAKEN INTO CONSIDERATION
BECAUSE HISTORICALLY THEY COULD
ACTUALLY CREATE SIGNIFICANT
INCREASES THAT ARE NOT
NECESSARILY SEEN AT OTHER TIMES.
NEXT SLIDE, PLEASE.
SO WHY DO WE SEE SUCH A HIGH
MORTALITY WITH METHAMPHETAMINE?
THE PROBLEM WITH METHAMPHETAMINE
IS THIS IS A DRUG THAT AFFECTS
MULTIPLE ORGANS.
CLASSICALLY WHEN IT COMES THE
BRAIN, WE SEE STROKES AND
CATECHOLAMIE TOXICITY, WITH THE
HEART WE SEE CARDIAC
ARRHYTHMIAS, DILATED
CARDIOMYOPATHY, HEART ATTACKS,
THOSE BY THEMSELVES ARE ALREADY
ENOUGH TO KILL THESE PATIENTS
AND INCREASE MORBIDITY, RIGHT?
BUT WHEN IT COMES TO PULMONARY
HYPERTENSION, THAT'S A MORE
NOVEL, IF YOU WILL, SINCE ITS
FIRST DESCRIPTION IN 1993 UNTIL
NOW THAT WE ARE ALREADY STARTING
TO UNRAVEL, BUT IT HAS A
SIGNIFICANT IMPACT ALSO IN THE
LIFESTYLE AND THE SURVIVAL OF
THE PATIENT.
IT IS INDISTINGUISHABLE
PATHOLOGICALLY TO THAT OF OTHER
PATIENTS WHICH IS WHY IT'S
CONSIDERED A GROUP ONE DISEASE.
NEXT SLIDE, PLEASE.
SO IN THIS STUDY IN 2017 WHERE
WE COLLECTED OUR DATA FROM YEARS
OF LOOKING AT THESE PATIENTS, WE
WERE ABLE TO COMPARE IPAH, 97
PATIENTS, AND 90 PATIENTS, WITH
METH PH, THIS WAS A STUDY DONE
WITH ROHAM ZAMANIAN AND STEVE
KAWUT BASED ON OUR STANFORD
DATASET AND WHAT WE FOUND WAS
THAT MOST OF THE PATIENTS WITH
METH APAH WERE MOSTLY MALE.
INTERESTINGLY ENOUGH, THEY AT
LEAST IN OUR GROUP, THE
SOCIOECONOMIC STATUS WAS
SIMILAR, THEY HAVE SIMILAR
HEMODYNAMIC BUT INTERESTINGLY
ENOUGH THEIR FUNCTION WAS WORSE
IN ECHO AND STILL FOUND THAT
METH APAH STAISHTS COMPARED WITH
IPAH PATIENTS HAD SIGNIFICANT
INCREASED MORTALITY.
NEXT SLIDE, PLEASE.
THIS, AGAIN, IF YOU LOOK AT THE
FAR REGISTRY, WE NEXT WENT TO
LOOK AT THE PHAR REGISTRY TO GET
MORE CLARITY REGARDING THE
CHARACTERISTICS OF THESE
PATIENTS.
WHY THE PHAR REGISTRY?
BECAUSE IT HAS A GOOD
REPRESENTATION OF METH APAH
PATIENTS FROM THE DIFFERENT
STHEARNTS PROVIDE DATA.
AGAIN, IF YOU COMPARE THIS MAP
WITH THE MAP OF METH FELT
MINIMUM OVERDOSES --
METHAMPHETAMINE OVERDOSES YOU
WILL SEE AGAIN THAT DIVISION IN
THE MIDDLE WHERE MOST OF YOUR
METH PATIENTS ARE ON THE WEST
AND AS YOU MOVE TO THE EAST
COAST, YOU START SEEING THAT THE
PREVALENCE OF IPH PATIENTS IS
ACTUALLY HIGHER.
SO NEXT SLIDE, PLEASE.
SO WHEN NOW IN THIS STUDY, LED
BY NICHOLAS KOLAITIS, WHAT WE
FOUND IS SOME THINGS THAT ARE
CLEARLY PUT TO A UNIQUE PATIENT
PROFILE FOR METH PAH PATIENTS.
FIRST OFF, THEY'RE YOUNGER, 47
YEARS VERSUS 55.
THESE PATIENTS ARE UNINSURED,
NEVER MARRIED, THEY DID NOT
FINISH COLLEGE, AND MOST OF THEM
FLENT A WORSE -- PRESENT THIS A
WORSE FUNCTIONAL CLASS COMPARED
TO IPAH.
NEXT SLIDE, PLEASE.
MOREOVER, THE HEMODYNAMICS
APPEAR TO BE WORSE BASED ON RA
PRESSURE, CARDIAC OUTPUT LOWER
AS WELL AS STROKE VOLUME SO
WORSE HEMODYNAMICS WHICH MAY
EXPLAIN WHY THESE PATIENTS ARE
DOING -- HAVE A WORSE MORTALITY.
SO THE NEXT QUESTION IS, WELL,
ARE THEY GETTING TREATED?
NEXT SLIDE, PLEASE.
SO THEY ARE GETTING TREATED
EXCEPT THAT IN OUR COHORT, THIS
IS FROM OUR STANFORD STUDY, WHAT
WE FOUND IS THAT MOST METH
PATIENTS ARE GETTING
INHALED/ORAL THERAPIES, GET
IV/SQ BUT IN LESS NUMBERS
COMPARED TO THE IPAH WHERE YOU
CAN SEE THAT A GREATER NUMBER
ARE ON IV SUB Q COMPARED TOIN
HAILED ORAL, AND THERE'S A
REASON FOR THAT, AND IT IS DUE
TO THE FACT THAT THESE PATIENTS
WHO MAY BE STILL ACTIVELY USING
OR MAY NOT HAVE SOCIAL SUPPORT
AND OTHER REQUIREMENTS TO
MAINTAIN, TO BE ABLE TO USE THIS
DRUG SAFELY, UNFORTUNATELY, IT'S
DIFFICULT FOR US TO BE ABLE TO
OFFER THESE THERAPIES UNTIL THEY
ARE ABLE TO REGAIN A BETTER
FUNCTIONAL AND SOCIAL STATUS,
WHICH OF COURSE IS NOT EASY TO
ASK OR REGAIN.
NEXT SLIDE, PLEASE.
THIS IS FROM A STUDY THAT IS
CURRENTLY UNDER REVIEW, AND WHAT
YOU CAN SEE HERE IS THAT ACROSS
THE UNITED STATES, USING
INSURANCE DATABASE LOOKING FOR
THE DIAGNOSIS OF METH AND
PULMONARY HYPERTENSION, THE RATE
AT WHICH THESE PATIENTS ARE
BEING TREATED, AND THIS IS A
STUDY WHERE WE WENT FROM 2017 TO
2022 INSURANCE CLAIM DATABASE,
AGAIN THE LIGHTER BLUE MEANS
THESE PATIENTS ARE GEG, IT'S A
PERCENT OF PATIENTS THAT ARE
GETTING MEDICATION.
LIGHTER BLUE, MORE PATIENTS.
DARKER BLUE, LESS PATIENTS.
AND YOU CAN SEE THAT AS WE NEUF
THE EAST COAST THERE'S MORE OF
THE DARK BLUE LESS PATIENTS
BEING PRESCRIBED OR RECEIVING
MEDICATIONS, WE CANNOT SAY THAT
THEY'RE NOT BEING PRESCRIBED, OR
THEY'RE JUST NOT GETTING THE
MEDICATION, YOU CAN SEE FOR
EXAMPLE IN FLORIDA, NEW JERSEY,
THESE AREAS ARE NOT THE PATIENTS
THAT ARE THERE, EVEN THOUGH
THERE MAY BE LESS PREVALENT THAN
ON THE WEST COAST, THERE ARE
STILL PATIENTS THERE THAT ARE
GETTING DIAGNOSED BUT THEY'RE
NOT BEING TREATED.
AND WE CAN TALK ABOUT WHAT
FACTORS DETERMINE THAT.
BUT ULTIMATELY, THIS POINTS TO A
BIG DISCREPANCY THAT MAY
EVIDENCE THE DISPARITY AFFECTING
THIS PARTICULAR PATIENT GROUP.
NEXT SLIDE, PLEASE.
SO WHAT ARE THE SOURCES OF
HEALTH DISPARITIES FOR METH
PULMONARY ARTERIAL HYPERTENSION?
THERE ARE SOME THINGS THAT ARE
UNIQUE, AND I AM GOING TO FOCUS
ON THOSE.
I WANT TO REITERATE THAT THIS IN
NO MEANS TAKES OUT THE SEX OR
THE OTHER SOCIAL DETERMINANTS OF
HEALTH THAT WE'VE DISCUSSED.
I'M JUST GOING TO FOCUS ON THE
THINGS THAT ARE PARTICULARLY
IMPORTANT FOR THIS PATIENT
POPULATION.
THERE'S THE LACK OF PHYSICIAN
AND PATIENT AWARENESS.
NOT EVERYBODY KNOWS THAT METH
CAUSES PAH OR WANT TO BELIEVE
IT, SO THAT'S ALREADY A PROBLEM
THAT LEADS TO PROBLEMS IN TERMS
OF HOW TO ADDRESS SCREENING THIS
PATIENT.
THERE'S OF COURSE THE IMPLICIT
BIAS FROM BEAU THE PATIENT AND
THE PHYSICIAN -- FROM BOTH THE
PATIENT AND THE PHYSICIAN, THE
PATIENT MISTRUST, THESE ARE
PATIENTS THAT USUALLY ARE SEEN
AS BEING SOCIAL PARIAHS AND NOT
RESPECT THE PATIENT BY ITSELF IS
ALREADY GOING TO COME WITH
MISTRUST.
THERE IS ALSO THE ACCESS TO CARE
BASED ON WHETHER THE PATIENT IS
ON A RURAL OR URBAN AREA.
THERE'S STIGMA AND
CRIMINALIZATION.
THESE PATIENTS HAVE ALREADY BEEN
IN JAIL OR HAVE ALREADY BEEN
FINED, SO THESE PATIENTS ARE
ALREADY HIGHLY HESITANT TO ENTER
THE SYSTEM TO RECEIVE CARE.
THERE'S A LACK OF TOXICOLOGY
SCREENING, LACK OF ADDICTION
SERVICES IN AREAS WHERE THESE
PATIENTS LIVE.
SO THESE PATIENTS PROBABLY FEEL
LIKE, YOU KNOW, THEY CAN THROW
IN THE TOWM BECAUSE THEY'RE NOT
GOING -- IN THE TOWEL BECAUSE
THAIRNLTD GOING TO BE RECEIVING
ANY CARE, SO WHY EVEN TRY.
AND THEN THERE'S THE LACK OF
PUBLIC HEALTH INITIATIVES TO
TARGET THESE POPULATIONS, SO
THAT OBVIOUSLY COMES FROM OUR
SIDE, OUR GOVERNMENTS AND OUR
COMMUNITIES TO PROVIDE THIS, AND
THEY'RE NOT WIDELY AVAILABLE.
NEXT SLIDE, PLEASE.
SO HOW CAN WE BRIDGE THIS GAP
FOR OUR METH PAH PATIENTS?
NEXT SLIDE, PLEASE.
THESE ARE THE THINGS AWE'RE
DOING IN OUR GROUP AS WELL AS
OTHER GROUPS THAT ARE TAKING
CARE OF THESE PATIENTS.
WE ARE VERY CLEAR AND
NONJUDGMENTAL WHEN WE ASK
PATIENTS ABOUT THEIR CURRENT OR
PAST METH USE, AND WE'RE VERY
CAREFUL WITH HOW WE ASK THEM
THAT, BECAUSE WE DON'T TO WANT
MAKE THE PATIENT FEEL SELF-AWARE
OR EMBARRASSED.
THIS IS SOMETHING THAT IS
ROUTINE AND WE ENCOURAGE THE
PATIENT TO ESTABLISH THAT TRUST.
THIS IS REALLY IMPORTANT.
WE SCREEN FOR BOTH HIV AND LIVER
DISEASE BECAUSE THESE ARE
COMORBIDITIES THAT ARE
PARTICULARLY IMPORTANT WITH THIS
PATIENT POPULATION.
WE ACTUALLY RUN URINE AND BLOOD
TOXICOLOGY FOR EVERY PATIENT, SO
WE DON'T DISCRIMINATE IN TERMS
OF ORDERING THIS.
WE SCREEN FOR MENTAL DISORDERS
OTHER THAN ADDICTION.
YOU CAN IMAGINE THESE PATIENTS
COME WITH OTHER BASED ON THE
LEVEL OF ABUSE THEY MAY HAVE
EXPERIENCED, OTHER SOCIAL
STRESSORS, THEY COME WITH
DEPRESSION, BIPOLAR DISORDER,
IT'S VERY IMPORTANT BECAUSE THIS
IS GOING TO BE A HUGE ASPECT OF
THE CARE AND THE SUCCESS THAT
YOU'RE GOING TO HAVE IN TREATING
THESE PATIENTS.
WE ESTABLISH A MEDICAL CONTRACT,
AND THIS IS SOMETHING THAT I CAN
SPEAK OFFLINE, BUT IT IS A
DOCUMENT THAT WE DISCUSS WITH
THE PATIENT AND WE SIGN WHERE WE
DISCUSS WHAT WE'RE PREPARED TO
OFFER AND WHAT WE ARE EXPECTING
FOR THE PATIENT.
WE DO RANDOM URINE TOXICOLOGIES
AND WE TELL THE PATIENT THAT
THIS IS GOING TO BE PART OF THE
CARE, SO THAT'S IN THE MEDICAL
CONTRACT.
WE'RE MINDFUL ABOUT USING IV
THERAPIES.
WHAT DOES THAT MEAN?
DOES THAT MEAN THAT WE DO NOT
OFFER IT?
ABSOLUTELY NOT.
BUT WE'RE VERY CAREFUL AND WE'RE
VERY CLEAR WITH THE PATIENT THAT
AS LONG AS THEY'RE ACTIVELY
USING, WE CANNOT IN GOOD
CONSCIENCE OFFER THE THERAPY.
WE DEFINITELY WANT TO HELP THE
PATIENT, WHICH IS WHY WE INVOLVE
AN ADDICTION SPECIALIST AND
SOCIAL WORKER, WE TRY TO
IDENTIFY THE BARRIERS TO
SUCCESS, LIKE IS THE PATIENT
LIVING IN AN AREA, ARE THEY
HOMELESS, CAN WE DO SOMETHING
ABOUT THAT?
CAN WE IMPROVE TRANSPORTATION
ACCESS TO CENTER?
SO WE TRY TO HELP THE PATIENT
COME UP WITH A POINT WHERE THEY
ARE BETTER CONNECTED, THEY HAVE
MORE SUPPORT, AND ULTIMATELY WE
CAN ACTUALLY INTRODUCE THIS
THERAPEUTIC, BUT IN THE
MEANTIME, EVERYTHING ELSE THAT
WE CAN OFFER, WE OFFER.
SO THAT'S REALLY IMPORTANT.
YOU DO NOT WITHHOLD THERAPY FOR
THESE PATIENTS.
NEXT SLIDE, PLEASE.
THE LAST THING I'M GOING TO SAY
IS THAT, YOU KNOW, WE CANNOT --
I WANT US TO ALSO START THINKING
THAT, YOU KNOW, METH DOES NOT
COME ALONG -- DOES NOT COME
ALONE.
PATIENTS WHO USE METH USUALLY
INVOLVE HIGH RISK SEXUAL
ACTIVITIES, THEY USE OTHER
DRUGS, SO THE FACT THAT HIV AND
METH CAN COME TOGETHER IS NO
SURPRISE.
THIS IS A HUGE PROBLEM HERE IN
THE BAY AREA WHERE MEN WHO HAVE
SESSION WITH MEN -- MEN WHO HAVE
SEX WITH MEN USE METHAMPHETAMINE
AS PART OF RECREATION, WHEN YOU
THINK OF THESE TWO GUYS COMING
TOGETHER, IT'S A DOUBLE HIT MADE
IN HELL.
NEXT SLIDE, PLEASE.
AND I'M GOING TO END UP BY
SHOWING YOU THIS, AND THIS IS
JUST FOOD FOR THOUGHT.
WHEN YOU LOOK AT THE PATIENTS
USE -- IDIOPATHIC USE OF
METHAMPHETAMINE IN THE GROUP,
YOU SEE OUT OF THIS GROUP 523,
33 INVESTIGATOR USED METH.
HIV PAH MUCH SMALLER BUT STILL A
HIGHER PROPORTION.
SO IS THERE A LINK BETWEEN THESE
TWO WELL-KNOWN CAUSES OF PAH?
THIS IS A SUBJECT FOR FUTURE
INVESTIGATION.
NEXT SLIDE, PLEASE.
SO AS I SAID, I THINK HOPEFULLY
AFTER FOCUSING ON DRUGS, I WANT
TO TAKE US BACK, I WANT TO ZOOM
OUT AND AGAIN PUT US BACK IN
PERSPECTIVE.
DRUG EXPOSURE IS AN IMPORTANT
PART OF WHAT DEFINES OUR
PATIENTS' ACCESS TO CARE, THEIR
OWN RESPONSE TO CARE, THEIR
TRUST, THEIR SUPPORT.
SO WE HAVE TO BE VERY CAREFUL
WHEN IT COMES TO THIS PATIENT
POPULATION BECAUSE IN ADDITION
TO EVERYTHING ELSE THAT WE HAVE
DEFINED SO FAR REGARDING
BARRIERS TO CARE AND
DETERMINANTS OF HEALTH, THIS BY
ITSELF CAN ALSO OPEN THE DOOR TO
OTHER COMPLEXITIES THAT WE AS
PHYSICIANS NEED TO BE AWARE, NOT
NECESSARILY BECAUSE WE CAN
TREAT, BUT ULTIMATELY AS WE TRY
TO THINK ABOUT HOW TO ADDRESS
THESE AND THINK ABOUT HOW TO
PROPERLY TREAT THESE PATIENTS,
HOW TO CONNECT THEM WITH THE
SYSTEM, WE ALSO HAVE TO THINK
ABOUT HOW ALL OF THESE FACTORS
INTERACT TOGETHER TO ULTIMATELY
DEFINE WHAT THIS INDIVIDUAL CAN
EXPECT FROM OUR SYSTEM AND WHAT
WE CAN EXPECT IN TERMS OF
OUTCOMES FOR THESE PATIENTS.
NEXT SLIDE, PLEASE.
VERY BRIEFLY, I HOPE I'VE
CONVINCED YOU THAT THIS IS AN
IMPORTANT FORM OF PULMONARY
HYPERTENSION, THINK ABOUT HIV
AND METHAMPHETAMINE, THEY NEED
TO BE SCREENED AT THE SAME TIME,
AND ALSO THIS IS A
MULTIDISCIPLINARY FORM OF PAH,
ALWAYS BE VERY CLEAR ABOUT
INVOLVING ADDICTION SPECIALISTS,
SOCIAL WORKERS, PSYCHIATRISTS,
BECAUSE ULTIMATELY THAT'S HOW
YOU'RE GOING TO SUCCESSFULLY
TREAT THESE PATIENTS.
SO WITH THAT, I BELIEVE MY NEXT
SLIDE IS COMING.
I WANT TO THANK YOU ALL.
I'M HAPPY TO TAKE QUESTIONS IF
THERE'S TIME.
>> THANK YOU, THAT WAS A
WONDERFUL OVERVIEW OF ESPECIALLY
A VERY PERTINENT TOPIC FOR US IN
THE SOUTHWEST.
YOU CAN ACTUALLY TRACK OUR
EPIDEMIC DOWN HERE, OUR IPH
POPULATION IS THIS, OUR METH
POPULATION IS THIS.
SO I'M SURE THERE ARE OTHER
CENTERS AS WELL.
I HAVE A QUICK QUESTION FOR YOU,
MAYBE NOT SO QUICK, BUT HOW MUCH
DO YOU THINK THAT THESE
DISPARITIES IN TREATMENT OF
METHAMPHETAMINE PATIENTS, YOU
SHOWED SORT OF THE NATIONAL MAP
AS WELL AS YOUR CENTERED, YOU
POINTED OUT THERE IS SOME
TREATMENT DISPARITY IN TERMS OF
PARENTERAL PROSTACYCLINS, HOW
MUCH OF THAT DO YOU THINK IS DUE
TO OUR OWN BIASES GOING INTO AND
ASKING OUR PATIENTS TO MODIFY
THEMSELVES OR THE WAY THAT WE
APPROACH PAH TREATMENT IN THEM,
AS OPPOSED TO US ADJUSTING OUR
OWN BIASES IN ACCORDANCE WITH
PERHAPS WHAT WILL WORK FOR THEM?
I'LL GIVE YOU AN EXAMPLE.
OUR PROGRAM HERE HAS A
MULTIDISCIPLINARY APPROACH TO
PATIENTS ALSO, BUT EVERY
PRACTITIONER SORT OF HAS
THEIR -- IN GRURNG HAS THEIR
SORT OF LEVEL OF OKAY THERE'S
THIS MUCH AMOUNT OF
SOCIOECONOMIC DISCORD IN A
PATIENT THAT WE BELIEVE THEY ARE
HIGH RISK FOR, SAY, PREANT
RESIDUAL THERAPY -- PA RENTED
RESIDUAL THERAPY, RIGHT?
WE'RE NOT GOING TO GO THAT FAR.
BUT DO WE HAVE THE DATA ACTUALLY
TO SHOW THAT THOSE PATIENTS ARE
ACTUALLY NOT GOING TO BE
ADHERENT TO PARENTERAL THERAPY,
SAY SUBCUTANEOUS THERAPY, IF A
GROUP OR A CENTER IS USED TO
GIVING IV THERAPY, THAT'S THEIR
PRACTICE PATTERN, RIGHT?
THEY MAY REFUSE THERAPY FOR A
PATIENT WHO USES
METHAMPHETAMINE, AS OPPOSED TO
MOVING TO SUBCUTANEOUS THERAPY
OR INHALED THERAPY, SOMETHING OF
THAT SORT.
SO JUST PUTTING THAT OUT THERE.
>> YEAH, THAT'S A VERY COMPLEX
YET RELEVANT QUESTION.
I WILL TELL YOU THAT ALL OF US
WHO WORK AT CENTERS WHERE THERE
IS HIGH EXPERTISE AND SUPPORT
FOR TREATING PULMONARY ARTERIAL
HYPERTENSION PATIENTS, WE WILL
ALL BE ABLE TO TAKE A LOOK AT
THESE PATIENTS, WE HAVE NURSES,
WE HAVE AN INFRASTRUCTURE THAT
WE CAN USE TO LEVERAGE TRYING TO
OFFER THESE PATIENTS THE MOST
IMPORTANT AND VITAL OPTIONS.
IN MY OWN EXPERIENCE AND I DON'T
KNOW DATD TO SAY THAT THESE
PATIENTS ARE NOT AS COMPLEX,
ALTHOUGH I CAN TELL YOU FROM OUR
STUDY, WHICH IS CURRENTLY UNDER
REVIEW, I CAN TELL YOU THAT WE
DID LOOK AT THE RATE OF
ADHERENCE OF PATIENTS, METH PAH
VERSUS NONMETH PAH IN THIS
PARTICULAR INSURANCE CLAIMS
ANALYSIS.
WE LOOKED AT MONOTHERAPY, DUAL
THERAPY AND TRIPLE THERAPY
ACROSS FROM THIS, AND WHAT WE
CAN TELL YOU, THOUGH, IS THAT AT
LEAST IN METH PAH, THERE IS
LOWER TREATMENT ADHERENCE BUT
NOT BY MUCH.
WE'RE TALKING ABOUT COMPARISON
BETWEEN WITH THE NON-METH PAH
THE DIFFERENCES ARE ABOUT 2.6, .
SO IT IS, IT IS SIGNIFICANT.
>> AS WE THOUGHT IT WOULD BE,
BASICALLY.
>> WELL, IT'S NOT LIKE WHAT YOU
WILL SAY, IT'S NOT REAL -- SO I
DON'T THINK THAT WE CAN USE THAT
TO JUSTIFY NOT OFFERING SYSTEMIC
PROSTEMOIDS TO A PATIENT.
WHAT I'M MORE SCARED ABOUT IS A
PATIENT WHO IS ACTIVELY USING
BECAUSE THESE PATIENTS USUALLY
DO NOT HAVE THE CAPACITY TO
MANAGE THE PROTOCOL REQUIRED TO
ADMINISTER THE DRUG.
IN SOME CASES, LIKE ONE OF THE
CASES I LIKE TO RELY ON, WE HAD
A PATIENT WITH AN INTRAVENOUS
LINE AND THEY USED TO INJECT
METHAMPHETAMINE THROUGH THAT
LINE.
AND SINCE, YOU KNOW, THAT'S ONLY
HAPPENED ONE TIME, WHICH IS WHY
FOR THESE PATIENTS, SO IF WE
HAVE A PATIENT, FOR EXAMPLE, A
METH USER WHO IS VERY, VERY,
VERY SICK, WE WILL PUT THEM ON
SUBCUTANEOUS THERAPY, AND WE
WILL SUPPORT THEM.
SO AGAIN, WE WILL NOT WITHHOLD.
BUT WE WILL BE VERY CAREFUL AND
SELECTIVE.
IF THERE'S NO OTHER CHOICE, THIS
IS A PATIENT WHOSE FUNCTIONAL
CLASS FOUR, THEY'RE GOING TO
DIE, WE WILL DEFINITELY START
THEM.
BUT ONCE WE STABILIZE THEM, IF
WE FEEL THAT THIS PATIENT IS NOT
A CANDIDATE TO BE AT HOME ON
THESE THERAPIES, THEN WE WILL
HAVE TO TRANSITION THEM
IN-HOUSE, WITH THE GOAL THAT
ULTIMATELY ONCE THE PATIENT IS
ABLE TO, YOU KNOW, BE ABLE TO BE
RESPONSIBLE AND SHOW THAT THEY
HAVE ADEQUATE SUPPORT AND A MORE
SOLID SOCIAL STRUCTURE AROUND
THEM, THEN WE CAN GO AHEAD.
BUT TO ADDRESS YOUR QUESTION, AT
THIS POINT IN TIME, IN MY OWN
EXPERIENCE, I THINK THESE
PATIENTS ARE INCREDIBLY
ADHERENT.
WE HAVEN'T HAD A PATIENT WHO HAS
BEEN LIKE -- IN FACT, ONCE THEY
ARE ON IV OR SUB Q MORE ADHERE
ENLT THAN WHEN THEY ARE ON ORALS
OR INHALES, TO BE PERFECTLY
HONEST WITH YOU.
BUT THAT'S MY OWN EXPERIENCE
WITH THESE PATIENTS.
>> GREAT.
THANK YOU.
WE NEED TO MOVE ON.
I APPRECIATE THAT VERY MUCH.
IT WAS AN EXCELLENT TALK AND
OVERVIEW ON PAH AND
METHAMPHETAMINE USE.
LET'S MOVE ON TO OUR NEXT TALK,
THAT IS PULMONARY VASCULAR
DISEASE AND SOCIAL DISPARITIES
AMONG THE UNHOUSED AND VETERAN
GROUPS.
DR. EVAN BRITAIN IS ASSOCIATE
PROFESSOR OF MEDICINE, HE'S A
CARDIOLOGIST AT VANDERBILT.
EVAN, GO AHEAD.
>> THANK YOU.
GOOD AFTERNOON, EVERYONE.
I APPRECIATE THE INVITATION FROM
THE CHAIRS AND THE NHLBI.
IT'S REALLY A PRIVILEGE TO BE
HERE.
I WAS ASKED TO SHARE SOME
THOUGHTS ON THE INTERSECTION OF
PULMONARY VASCULAR DISEASE,
SOCIAL DISPARITIES AMONG THE
HOMELESS AND VETERANS GROUP, AND
I INTERPRETED THAT AND TREAT
THOSE AS SEPARATE GROUPS,
ALTHOUGH CERTAINLY THERE'S SOME
OVERLAP AND I'LL TOUCH ON THAT
AS WELL.
ONE OF THE EARLY DISCLAIMERS IS
THAT THIS IS REALLY A DATA-FREE
ZONE WITH RESPECT TO HOMELESS
INDIVIDUALS.
SO IF YOU'LL INDULGE ME, I'LL
TRY TO CONNECT SOME DOTS BETWEEN
SOCIAL DISPARITIES, CHALLENGES
FAILED BY HOMELESS INDIVIDUALS
AND HOW THAT MIGHT CREATE THE
CONDITIONS FOR DEVELOPMENT OF
PULMONARY VASCULAR DISEASE.
NEXT SLIDE.
SO THIS IS A SNAPSHOT OF
HOMELESSNESS IN AMERICA, DRAWING
YOUR ATTENTION ON THE FIGURE ON
THE LEFT FIRST, THIS IS NUMBERS
OVER TIME OF CHRONIC
HOMELESSNESS DEFINED HERE AS
EXTENDED PERIOD OF BEING WITHOUT
THE SHELTER.
AND IF YOU CONSIDER ON ANY GIVEN
NIGHT, THE NUMBERS ARE ABOUT
THREE TO FOUR FOLDER HIGHER, BUT
THIS IS DATA FOR CHRONIC
HOMELESSNESS.
YOU CAN SEE THERE'S AN UPTICK
OVER THE LAST SEVERAL YEARS.
I DON'T THINK THERE'S ANY SINGLE
CAUSE OF THAT, BUT SOME
CONTRIBUTORS THAT HAVE BEEN
CITED AND SEEM TO BE SORT OF
CONSENSUS CONTRIBUTORS ARE
GENERAL ECONOMIC INSTABILITY
OVER THE LAST SEVERAL YEARS,
COUPLED WITH INFLATION, COVID
PANDEMIC, WHICH AFFECTED
INDIVIDUALS WHO WERE SORT OF ON
THE MARGINS IN TERMS OF ECONOMIC
STABILITY MORE SO THAN OTHERS,
WITHDRAWAL OF COVID ASSISTANCE
DURING THE PANDEMIC, AND SOME
OTHER CAUSES.
ONE OF THE DISPARITIES AMONG THE
HOMELESS THAT IS REALLY
IMPORTANT TO CONSIDER IS
DISPLAYED ON THE RIGHT.
HERE YOU SEE IN GREEN THE
DISTRIBUTION OF DIFFERENT RACIAL
GROUPS IN THE U.S., AND IN BLUE
IS THE DISTRIBUTION AMONG THE
HOMELESS POPULATION.
SO ANYWHERE THAT THE BLUE BAR IS
LONGER THAN THE GREEN BAR
ACCIDENT THERE'S A RACIAL
DISPARITY IN TERMS OF
REPRESENTATION AMONG THE
HOMELESS.
YOU SEE THAT AS PARTICULARLY
MARKED AMONG BLACK INDIVIDUALS,
HISPANICS AND OTHERS.
NEXT SLIDE.
THERE ARE SOME DATA AMONG
VETERANS.
THIS IS VETERANS EXPERIENCING
HOMELESSNESS IN THE U.S., AND
YOU CAN SEE THAT THIS IS A
LITTLE BIT MORE OF A POSITIVE
PICTURE.
THERE'S A DECLINE OVER THE LAST
TEN TO TWELVE YEARS.
THIS IS LARGELY ATTRIBUTED ON A
LARGE INVESTMENT FROM THE OBAMA
ADMINISTRATION AND HOUSING AND
URBAN DEVELOPMENT AND IS REALLY
CITED AS A SUCCESS STORY FOR
ALLEVIATING HOMELESS VETERANS.
NEXT SLIDE, PLEASE.
SO THERE'S A LOT ON THIS SLIDE,
AND THE DETAILS ARE LESS
IMPORTANT THAN THE OVERALL
MESSAGE, AND THIS IS PROBABLY
ONE OF THE MORE IMPORTANT POINTS
THAT I WANT TO MAKE.
REALLY IT'S JUST TO HIGHLIGHT
THE INTERACTIONS AMONG SOCIAL
DISPARITIES, HOMELESSNESS AND
CHRONIC HEALTH CONDITIONS.
THE KEY POINT IS THAT THE
CONDITIONS AMONG SOCIAL
DISPARITIES SUCH AS POVERTY,
TRAUMA, DISCRIMINATION, CREATE
THE CONDITIONS THAT INCREASE
RISK FOR HOMELESSNESS, AND THEY
ALSO INCREASE RISK FOR VARIOUS
CHRONIC DISEASES.
THE EXPERIENCE OF BEING HOMELESS
AND THE CHALLENGES WITH
RECEIVING MEDICAL CARE AND
TREATING CHRONIC CONDITIONS
REALLY MAKE IT MORE DIFFICULT TO
EMERGE FROM THE HOMELESS
CONDITION AND THE RESULT IS AN
INCREASE IN CHRONIC DISEASES
ACROSS THE HUMAN PHENOME AS WELL
AS MARKED INCREASE IN THE RATES
OF MENTAL HEALTH CONDITIONS AND
SUBSTANCE USE DISORDERS.
NEXT SLIDE, PLEASE.
THIS IS A LOOK AT UNMET
HEALTHCARE NEEDS AMONG HOMELESS
ADULTS.
THESE DATA ARE A LITTLE OLDER,
ABOUT 1,000 SURVEYED HOMELESS
INDIVIDUALS.
WHAT WE SEE IS ABOUT A THIRD OF
THOSE INDIVIDUALS HAD UNMET
MEDICAL OR SURGICAL CARE NEEDS,
ABOUT A THIRD NEEDED
PRESCRIPTIONS THAT WEREN'T
OBTAINED, AND PERHAPS SORT OF
OBVIOUS NOW THAT WE'RE SEEING IT
BUT IT CERTAINLY WASN'T ON THE
FOREFRONT OF WHAT I WAS
THINKING, THE BIGGEST NEEDS WERE
EYEGLASSES AND DENTAL CARE,
WHICH MAKES A LOT OF SENSE.
THOSE ARE MAJOR DRIVERS OF
QUALITY OF LIFE AND REALLY
IMPORTANT UNMET HEALTHCARE NEEDS
AMONG THE HOMELESS.
NEXT SLIDE.
SO LOOKING HERE AT ALL CAUSE
MORTALITY AMONG THE HOMELESS,
THESE ARE CENSUS DATA.
THE Y AXIS IS THE PROBABILITY OF
DEATH.
THOSE NUMBERS ARE QUITE LOW
BECAUSE IT'S JUST A SIX-MONTH
PERIOD, BUT YOU CAN EXTRAPOLATE
AND THE SEPARATION WOULD BE THE
SAME.
I THINK THE KEY TAKE AWAY HERE
IS THE WIDE GAP BETWEEN THE
HOMELESS POPULATION WHICH IS THE
TOP LINE AND THOSE WHO ARE POOR
BUT HAVE A HOME, AND THAT'S THE
SECOND LINE THERE, WHICH THEY DO
WORSE THAN INDIVIDUALS WHO ARE
NOT POOR, BUT THE BIG GAP REALLY
IS BETWEEN -- IS REALLY IMPOSED
BY VIRTUE OF BEING HOMELESS.
NEXT SLIDE, PLEASE.
OR ADVANCE.
THANK YOU.
THESE ARE DATA, ALL CAUSE
MORTALITY AMONG THE VETERAN
POPULATION USING NATIONAL DEATH
INDEX DATA.
THIS IS A MUCH LONGER TERM
STUDY, THE FOLLOW-UP IS LONGER
THAN TEN YEARS, AS YOU CAN SEE
ON THE X AXIS.
AND HERE THEY'VE STRATIFIED
BASED ON NOT JUST HOMELESS
STATUS BUT ALSO AGE.
NOT SURPRISINGLY, OLDER
INDIVIDUALS HAVE HIGHER
MORTALITY THAN YOUNGER
INDIVIDUALS, BUT YOU CAN SEE
THAT THE SOLID LINES ARE BOTH
VETERAN AND HOMELESS
POPULATIONS, THOSE ARE BOTH
SHIFT DOWN QUITE A BIT.
SO THE MEDIAN SURVIVAL IN OLDER
HOMELESS VETERANS IS ABOUT TEN
YEARS.
NEXT SLIDE.
SO GETTING CLOSER, TRYING AT
LEAST AND GETTING CLOSER TO
CONNECTING THE DOTS WITH
PULMONARY VASCULAR DISEASE, THIS
IS NOW LOOKING AT HOMELESS
INDIVIDUALS AND RISK OF HEART
DISEASE.
THIS IS A META-ANALYSIS OF NINE
STUDIES.
THESE ARE POPULATIONS ACROSS THE
WORLD.
SO MORE THAN JUST THE UNITED
STATES.
WHAT YOU SEE IS THERE'S AN
INCREASED RISK OF CARDIOVASCULAR
DISEASE AMONG THE HOMELESS, THE
BOTTOM SQUARE THERE SHOWS THAT
THE OVERALL ODDS OF
CARDIOVASCULAR DISEASE ARE ABOUT
TWO TO THREEFOLD HIGHER AMONG
THE HOMELESS COMPARED TO THOSE
WHO AREN'T.
NEXT SLIDE.
SO I THINK ONE OF THE MORE SORT
OF SUCCINCT AND CLEVER WAYS OF
PUTTING THIS WAS FROM ONE OF THE
EDITORIALS I CAME ACROSS WHICH
SAYS THAT HOMELESSNESS IS A
CAUSE OF THE CAUSES OF
CARDIOVASCULAR DISEASE, AND I'LL
TRY TO CONVINCE YOU THAT THAT'S
ALSO -- HOMELESSNESS IS ALSO A
CAUSE OF THE CAUSES OF PULMONARY
VASCULAR DISEASE.
THIS IS AN ILLUSTRATION FROM A
RECENT REALLY WELL DONE REVIEW
ARTICLE FROM JACK AND IT
DISCUSSES -- FROM JACC AND
DISCUSSES THAT HOMELESS
INDIVIDUALS HAVE TRADITIONAL
RISK FACTORS FOR CARDIOVASCULAR
DISEASE, ABOUT 06 TO 80% ARE
SMOKERS OR FORMER SMOKERS, THAT
DRIVES A LOT OF THE ISCHEMIC
HEART DISEASE IN THIS
POPULATION.
INTERESTINGLY, AT LEAST BY THE
REPORTS THAT ARE PUBLISHED, THE
PREVALENCE OF HYPERTENSION AND
DIABETES IS FAIRLY SIMILAR
BETWEEN HOMELESS INDIVIDUALS AND
THOSE WHO AREN'T HOMELESS,
ALTHOUGH I SUSPECT THERE'S
PROBABLY QUITE A BIT OF
UNDERDIAGNOSIS OR MISDIAGNOSIS
THERE.
BUT IT'S ALSO IMPORTANT THAT
THESE COMORBIDITIES ARE LESS
WELL CONTROLLED IN THE HOMELESS
POPULATION, THAT'S PRETTY WELL
ESTABLISHED.
AND THEN ON THE TOP RIGHT, THERE
ARE ALSO QUITE A BIT OF
HEIGHTENED NONTRADITIONAL RISK
FACTORS, INCLUDING CHRONIC
STRESS, AND WE'LL HEAR SOME
EXPERT COMMENTARY ON ALLOSTERIC
LOAD, INCREASED RISK OF
DEPRESSION, HEAVY ALCOHOL AND
COCAINE USE, AND THEN A SPECIAL
RISK FACTOR THAT'S HEIGHTENED
AMONG THE VETERANS -- OR THE
HOMELESS RATHER IS HIV, AND
SOMEWHERE BETWEEN TWO TO TEN
PERCENT OF HOMELESS INDIVIDUALS
ARE HIV POSITIVE DEPENDING ON
THE POPULATION THAT YOU STUDY.
SO YOU TAKE THESE INCREASED
CARDIOVASCULAR RISK FACTORS AND
YOU LAYER ON THAT THE DIFFICULTY
WITH DIAGNOSING CARDIOVASCULAR
DISEASE IN THIS POPULATION AND
THAT STEMS FROM CHALLENGES
AROUND THE LOGISTICS OF TESTING,
WHICH I'LL COMMENT ON, THE LACK
OF USUAL CARE SOURCES, AND OTHER
CAUSES.
SO EVEN IF YOU CAN DIAGNOSE
CARDIOVASCULAR DISEASE IN THIS
POPULATION, THEN YOU'RE FACING
DIFFICULT MANAGEMENT
CONSIDERATIONS.
THERE ARE ALL KINDS OF
CHALLENGES WITH OBTAINING
MEDICATIONS, STAYING ADHERENCE,
THERE'S FRAGMENTATION OF CARE
BECAUSE THE ACCESS TO CARE IS
LIMITED AMONG MANY OF THESE
POPULATIONS.
AND ALL OF THESE CONVERGE TO
INCREASE RISK OF CARDIOVASCULAR
DISEASE, WHICH IS A MAJOR
CONTRIBUTOR TO DEATH AMONG THE
HOMELESS POPULATION.
IF YOU LOOK ACROSS REALLY ALL
AGE GROUPS AMONG THE HOMELESS,
HEART DISEASE AND CANCER ARE
VIRTUALLY IDENTICAL, BUT THEY'RE
THE SECOND LEADING CAUSE OF
DEATH ACROSS ALL AGE GROUPS FOR
THE HOMELESS POPULATION.
NEXT SLIDE, PLEASE.
SO I HAVEN'T FORGOTTEN ABOUT THE
PULMONOLOGISTS IN THE GROUP.
THERE ALSO IS AN INCREASED RISK,
NOT SURPRISINGLY, IN PREVALENCE
OF PULMONARY DISEASE IN THE
HOMELESS.
THIS IS A NICE STUDY IN THE
GREATER LONDON AREA, I THINK
COMMON -- LOOKING AT CHRONIC
COMMON CO-MORE DID TIZ.
ONE IS LEAST DEPRIVED, FIVE IS
MOST DEPRIVED.
IF YOU SQUINT THERE'S A STEP
WISE INCREASE AS THE DEPRIVATION
INDEX WORSENS BUT THEN THERE'S
THIS HUGE JUMP WHEN IT COMES TO
HOMELESS STATUS.
YOU SEE THAT WITH HEART DISEASE,
BUT PARTICULARLY PRONOUNCED WITH
CHRONIC RESPIRATORY DISEASES,
PARTICULARLY COPD AND ASTHMA.
SO WHAT YOU FOUND IS THAT
THERE'S AN INCREASE BOTH WITH
CARDIOVASCULAR AND PULMONARY
DISEASE THAT WE KNOW ARE THE
MAJOR UNDERLYING RISK FACTORS
FOR MOST OF THE PULMONARY
HYPERTENSION IN THE U.S. AND
WORLDWIDE.
NEXT SLIDE.
SO THIS WAS MY ATTEMPT TO
CONNECT SOME DOTS IN THE
HOMELESS POPULATION WHERE THERE
REALLY IS NOT ANY DIRECT DAFT ON
PULMONARY VASCULAR DISEASE.
IF I MISS IT, ARE PLEASE BRING
IT UP IN THE DISCUSSION.
THIS IS ALSO NOT AN ATTEMPT
ALTHOUGH AN ATTEMPTED ACYCLIC
GRAVMENT I APOLOGIZE TO ANY OF
THE EPIDEMIOLOGISTS, THERE ARE
PROBABLY SOME MISSING ARROWS
HERE AND LOOPS I DIDN'T CONNECT.
BUT THE POINT I WANT TO MAKE IS
THAT SOCIAL DISPARITIES IN
HOMELESSNESS ARE RISK FACTORS
FOR ONE ANOTHER AND THEY
EXACERBATE ONE ANOTHER.
THEY BOTH CONTRIBUTE TO THE
DEVELOPMENT OF RISK FACTORS FOR
CARDIOVASCULAR AND PULMONARY
DISEASE, WHICH IN TURN ARE OF
COURSE THE GREATEST RISK FACTORS
FOR PULMONARY VASCULAR DISEASE.
SO I'VE TRIED TO MAKE THOSE SORT
OF LOGICAL EXTENSIONS.
JUST A BRIEF COMMENT ON SOME OF
THE SPECIAL CHALLENGES WITH
RESPECT TO PULMONARY VASCULAR
DISEASE DIAGNOSIS AND MANAGEMENT
IN THE HOMELESS POPULATION.
THOSE OF US WHO EVALUATE THESE
PATIENTS IN THE CLINIC KNOW THAT
THE EVALUATION OF COURSE
DEPENDING ON SORT OF UNDERLYING
CONSIDERATIONS IS
TIME-CONSUMING, IT'S OFTEN
COSTLY, AND IN MANY CASES TO GET
THE DEFINITIVE DIAGNOSIS
REQUIRES AN INVASIVE ASSESSMENT.
SO THERE ARE LOTS OF CHALLENGES
AROUND COMPLETING A THOROUGH
DIAGNOSTIC WORK-UP IN THE
HOMELESS POPULATION.
THEN THERE'S ALSO SOME
LIMITATIONS AROUND TREATMENT AND
A LOT OF THESE PATIENTS REQUIRE
FREQUENT DIURETIC ADJUSTMENTS
WHICH IN A PERFECT WORLD ALSO
COME ALONG WITH ELECTROLYTE
MONITORING AND FREQUENT
FOLLOW-UP, WHICH ISN'T ALWAYS
PRACTICAL AND OF COURSE SOME OF
THE MORE ADVANCED TREATMENTS FOR
PULMONARY ARTERIAL HYPERTENSION
IN PARTICULAR INCLUDING
INFUSIONS REPRESENT A PARTICULAR
CHALLENGE IN THIS POPULATION.
SO I'M GOING TO TRANSITION NOW
TO PULMONARY VASCULAR DISEASE
AMONG U.S. VETERANS WHICH WE
KNOW A LITTLE BIT MORE ABOUT BUT
FIRST I WANT TO GIVE SOME
BACKGROUND ABOUT U.S. VETERANS.
THE FIRST POINT IS THAT THERE
ARE A LOT OF THEM.
THERE ARE 18 MILLION VETERANS,
THAT'S ABOUT 1 IN 14 U.S.
ADULTS.
ABOUT HALF OF THE ADULTS OVER 65
ARE U.S. VETERANS, WHICH IS A
PRETTY STRIKING NUMBER, IF YOU
JUST PAUSE TO THINK ABOUT THAT.
ADVANCE.
ABOUT A QUARTER OF VETERANS ARE
MINORITIES, AND AMONG ACTIVE
DUTY VETERANS, SERVICE MEMBERS,
43 PERCENT ARE MINORITY.
SO MOST OF THOSE WHO ARE OVER 65
ARE WHITE, AND AS THEY PASS
AWAY, THE PROPORTION OF VETERANS
WHO ARE MINORITIES WILL GROW
SUBSTANTIALLY OVER THE COMING
YEARS.
ADVANCE, PLEASE.
SO IF YOU'LL FORGIVE THE SOAPBOX
MOMENT, I JUST WANT TO EMPHASIZE
HOW MANY WOMEN VETERANS THERE
ARE.
SO 10% OF VETERANS ARE WOMEN,
THAT'S ABOUT 2 MILLION WOMEN,
AND WITHOUT FAIL, WHEN WE
PRESENT DATA ON THE VETERAN
POPULATION FOR STUDYING
PULMONARY VASCULAR DISEASE, THE
CRITICISM IS THEY'RE MOSTLY MEN,
AND THAT'S TRUE AS A PERCENTAGE,
BUT THE ABSOLUTE NUMBER OF WOMEN
VETERANS IS MORE THAN
FRAMINGHAM, CARDIA, ERIC, MESA
AND OTHER NHLBI COHORT COMBINED.
SO I SORT OF BRISTLE WITH THE
NOTION THAT THE VETERAN
POPULATION IS INVALUABLE FOR
LEARNING ABOUT PULMONARY
VASCULAR DISEASE IN WOMEN.
NEXT SLIDE.
SO JUST A LITTLE BACKGROUND
ABOUT SOCIODEMOGRAPHICS OF U.S.
VETERANS, AS I JUST SHOWED YOU,
THEY TEND TO BE OLDER THAN
NONVETERANS, THEY'RE MORE LIKELY
TO BE MARRIED, THE EDUCATIONAL
PROFILE IS PRETTY INTERESTING.
SIMILAR RATES OF LESS THAN HIGH
SCHOOL EDUCATION, BUT
INTERESTINGLY THERE'S AN
INCREASED PROPORTION OF WHANS
WHO ARE COLLEGE EDUCATED IN
LIGHT OF ACCESS TO THE GI BILL.
THE UNEMPLOYMENT DATA ARE A
LITTLE BIT HARD TO INTERPRET
BECAUSE MANY OF THESE VETERANS
ARE RETIRED, BUT AMONG THOSE WHO
ARE NOT RETIRED, UNEMPLOYMENT
RATES ARE FAIRLY SIMILAR BETWEEN
VETERANS AND NONVETERANS.
HOUSEHOLD INCOME IS A LITTLE BIT
HIGHER AMONG VETERANS, PROBABLY
AGAIN REFLECTING AGE AND LONGER
EARNING POTENTIAL.
AND THEN THERE ARE INCREASED
RATES OF HOMELESSNESS AND
SUBSTANTIALLY INCREASED RATES OF
MENTAL HEALTH CONDITIONS,
DEPRESSION AND PTSD IN
PARTICULAR AS WELL AS SUBSTANCE
USE.
WHILE I'M ON THIS SLIDE, I GOT
SOME DATA THIS MORNING THAT I
DIDN'T HAVE TIME TO INTEGRATE
BUT I WANTED TO SHARE, WHICH IS
AMONG THE SOCIODEMOGRAPHIC
FEATURES THAT ARE RISK FACTORS
OR PROTECTIVE FOR PULMONARY
HYPERTENSION, THE STRONGEST
PROTECTIVE FEATURE AMONG U.S.
VETERANS AGAINST PULMONARY
HYPERTENSION RISK WAS BEING
MARRIED, AND IN A POPULATION
THAT'S PREDOMINANTLY MALE, I'LL
LET YOU MAKE YOUR OWN
INTERPRETATION OF THAT FINDING.
NEXT SLIDE, PLEASE.
THIS GIVES A LITTLE BIT MORE
ABOUT THE COMORBIDITY PROFILE
AMONG U.S. VETERANS.
YOU SEE INCREASED RATES OF COPD,
INCREASED RATES OF DIABETES, AND
PARTICULARLY HIGHER RATES OF
MENTAL HEALTH CONDITIONS, IN
PARTICULAR AS I SAID PTSD ON THE
FAR RIGHT.
NEXT SLIDE, PLEASE.
SO NOW I'M GOING TO SHOW YOU A
LITTLE BIT OF SORT OF THE RAW
DATA THAT WE KNOW ABOUT
PULMONARY VASCULAR DISEASE AND
PULMONARY HYPERTENSION IN THE
VETERAN POPULATIONS.
BY AND LARGE, THESE ARE
COMPARISONS OF VETERANS WITH THE
VANDERBILT POPULATION BECAUSE
THAT'S WHAT WE HAVE ACCESS TO
AND IS A LARGE TERTIARY CARE
CENTER OF PATIENTS SEEKING CARE.
AND THIS IS GOING TO BE A
COMPARISON OF INDIVIDUALS WHO
WERE REFERRED FOR
ECHOCARDIOGRAMS.
THIS IS NOT THE POPULATION IN
GENERAL, THESE ARE PATIENTS
SEEKING CARE AND THEIR PROVIDER
HAD SOME REASON TO ORDER AN
ECHOCARDIOGRAM.
SO PRESUMABLY SOME SUSPICION OF
CARDIOPULMONARY DISEASE.
THE AGE OF INDIVIDUALS REFERRED
FOR ECHO IS FAIRLY SIMILAR.
AGAIN, THE PROPORTION OF
VETERANS WHO ARE MALES IS MUCH
HIGHER.
VANDERBILT IS A LITTLE BIT MORE
BALANCED.
THE BMI IS SIMILAR.
THERE IS A HIGHER PROPORTION OF
BLACK AND HISPANIC INDIVIDUALS
AMONG VETERANS WHO WERE REFERRED
FOR ECHO.
HEART FAILURE RATES ARE FAIRLY
SIMILAR, AS YOU CAN SEE, 18
VERSUS 21-H THE SUBSTANTIALLY
MORE, MORE THAN TWICE AS HIGH,
PREVALENCE OF COPD AMONG
VETERANS.
LOTS OF PEOPLE HAVE
HYPERTENSION.
THIS IS AN OLDER POPULATION, SO
THOSE RATES ARE FAIRLY SIMILAR.
BUT THERE IS INTERESTINGLY A
MUCH HIGHER PREVALENCE OF
DIABETES AMONG VETERANS COMPARED
IN THIS CASE TO THE VANDERBILT
POPULATION.
I SUSPECT THERE ARE SORT OF
SCREENING AND DIAGNOSIS METRICS
WITHIN THE VA THAT THEY'RE
PROBABLY MORE VIGOROUS THAN
VANDERBILT IN THAT WAY,
EXPLAINING PART OF THAT
INCREASE.
NEXT SLIDE.
SO THIS IS LOOKING AT A LARGE
POPULATION OF VETERANS AND
VANDERBILT PATIENTS WHO HAVE AN
ECHO REFERRAL AS WELL AS A
PULMONARY PRESSURE ESTIMATE.
SO ABOUT 389,000 VETERANS.
I'LL NOTE THAT ABOUT 25,000 OF
THOSE INDIVIDUALS ARE WOMEN, AND
ABOUT 117,000 INDIVIDUALS FROM
VANDERBILT.
IF YOU LOOK AT THE PREVALENCE OF
PULMONARY HYPERTENSION, WHICH IS
IN A GIVEN INDIVIDUAL DO THEY
EVER HAVE A PH -- A PASP GREATER
THAN 35, THE PREVALENCE IS ABOUT
ONE IN THREE FOR BOTH
POPULATIONS.
AND YOU COULD CERTAINLY QUIBBLE
WITH 35 AS A CUTOFF.
MORE SENSITIVE, LESS SPECIFIC.
BUT THE RELATIVE PRO POURINGS
ARE FAIRLY SIMILAR BETWEEN
VETERANS AND NONVETERANS.
AND THEN I'M GOING TO GET INTO
THE INCIDENT RATES ON THE NEXT
SLIDE, AND I JUST WANT TO
HIGHLIGHT THAT MOST OF WHAT WE
KNOW FROM COHORT STUDIES AND
PULMONARY HYPERTENSION RELATES
PREVALENCE OF PULMONARY
HYPERTENSION, WE KNOW RELATIVELY
LESS ABOUT PH INCIDENTS.
-- INCIDENCE.
SO IN THIS STUDY WE IDENTIFIED
PEOPLE WHO HAD HAD AN ECHO WITH
A PULMONARY PRESSURE LESS THAN
35, SO EVIDENCE OF LACK OF
PULMONARY HYPERTENSION AT
BASELINE AND THEN LOOKED AT
SUBSEQUENTLY WHO WENT ON TO
DEVELOP PH ON A FUTURE ECHO.
AND THIS IS A BUSY TABLE, BUT
I'LL JUST DRAW YOUR ATTENTION TO
THE TWO RED BOXES.
THE TOABLGHTS INCIDENCE RATES
ARE -- TOTAL INCIDENCE RATES ARE
SIMILAR, 22 PER 1,000 PATIENT
YEARS VERSUS 25 PER 1,000
PATIENT YEARS.
FOR VISUALIZATION PURPOSES WE
STRATIFIED THESE INDIVIDUALS
BASED ON HEART FAILURE AND COPD
STATUS BECAUSE THAT'S FAR AND
AWAY THE MOST COMMON CAUSES OF
PH IN BOTH OF THESE POPULATIONS.
INTERESTINGLY WHAT YOU SEE IS
THAT THE INCIDENCE RATES OF PH
IS FAIRLY SIMILAR BETWEEN THESE
TWO POPULATIONS IF YOU CONSIDER
THAT IT'S PER 1,000 PATIENT
YEARS.
COPD IS HIGHER THAN NOT HAVING
COPD, HEART FAILURE IS HIGHER
THAN THE HAVING COPD AND THEN
THE COMBINATION IS ESSENTIALLY
ADDITIVE.
BUT AGAIN, ON A POPULATION LEVEL
FAIRLY SIMILAR RATES BETWEEN
THESE TWO COHORTS.
NEXT SLIDE.
BUT WHAT'S INTERESTING WHAT
HAPPENS AFTER THE DIAGNOSIS OF
INCIDENT PH.
SO THIS IS AN ALL CAUSE
MORTALITY CURVE STRATIFIED BY
HEART FAILURE AND COPD STATUS.
NEITHER IS THE CURVE ON THE TOP,
BOTH IS THE CURVE ON THE BOTTOM
FOR BOTH OF THESE, AND THE
SEPARATION IS FAIRLY SIMILAR
BASED ON HEART FAILURE AND COPD
STATUS, BUT WHAT YOU SEE IS THAT
THE VA CURVE ALL OF THOSE CURVES
ARE SHIFT SHIFTED DOWN.
SO THE PROGNOSIS AMONG VETERANS
AFTER A DIAGNOSIS OF PH IS
SUBSTANTIALLY WORSE COMPARED TO
THE CONTROL POPULATION, THE
CIVILIAN POPULATION, RATHER, AT
VANDERBILT.
SO THAT HAS SOME IMPLICATIONS
AROUND POTENTIALLY PH
RECOGNITION OR MANAGEMENT,
COMPETING RISKS, AND OTHER
INFLUENCES ON LARGER OUTCOMES.
NEXT SLIDE.
SO THAT WAS DATA ON ECHO
CARDIOGRAPHIC PULMONARY
HYPERTENSION AMONG VETERANS.
HERE WE'RE LOOKING AT PH
PREVALENCE AND PHENOTYPES AMONG
PATIENTS REFERRED FOR RIGHT
HEART CATHETERIZATION.
AGAIN, NOT AN UNSELECTED
POPULATION, THESE WERE PATIENTS
REFERRED FOR RIGHT HEART CATH
AND IF YOU LOOK AT CONSECUTIVE
INDIVIDUALS AT VANDERBILT AND
VA, SLIGHTLY HIGHER MILD PH
AMONG VETERANS, SLIGHTLY HIGHER
MORE SEVERE PH AMONG THE
VANDERBILT POPULATION.
AND THEN LOOKING SPECIFICKING AT
PULMONARY VASCULAR DISEASE USING
PVR AND AGAIN YOU CAN ARGUE
ABOUT THE CUTOFFS, SLIGHTLY
HIGHER AMONG VANDERBILT PATIENTS
FOR INCREASED RISK OF SEVERE
PULMONARY VASCULAR DISEASE.
NEXT SLIDE.
SO I JUST WANT TO END WITH A
COUPLE OF SPECIFIC RISK FACTORS
IN PH AND I'LL WRAP UP SHORTLY.
SO HIV IS A SPECIFIC RISK FACTOR
FOR PULMONARY ARTERIAL
HYPERTENSION WE KNOW AND THERE'S
SOME DATA FROM THE VA POPULATION
SUGGESTING THAT'S ALSO AN
INDEPENDENT RISK FACTOR FOR
OTHER CAUSES OF PH AMONG
VETERANS.
ON THE LEFT YOU CAN SEE THIS IS
COMPARING VETERANS WITH HIV TO
VETERANS WITHOUT HIV, HIGHER
INCIDENCE OF PH AMONG THOSE WITH
HIV, AND WHEN YOU DO A TIME
DEFINITIVE ANALYSIS ADJUSTING
FOR LOTS OF CO-VARIATES THAT
RISK IS INCREASED BY ABOUT
18 PERCENT.
NEXT SLIDE, PLEASE.
I WANT TO BRING ATTENTION TO
ANOTHER SORT OF EMERGING AND
NOVEL RISK FACTOR FOR PVD WHICH
IS NOT PARTICULARLY A SOCIAL
DISPARITY EXCEPT THAT IT'S A
RISK FACTOR THAT'S UNIQUE TO
VETERANS, AND THAT IS BURN PIT
EXPOSURE.
THIS FIRST GAINS SOME
RECOGNITION IN THE EARLY 2000S
AMONG SOLDIERS WHO ARE RETURNING
WITH UNEXPLAINED DYSPNEA FOUND
TO HAVE CONSTRICTIVE BRON YOA
LIGHTS AMONG LUNG BIOLOGY,
FOLLOWED UP BY PATHOLOGISTS AT
VANDERBILT WHO DID ANALYSIS OF
52 OPEN LUNG BIOPSIES,
UNEXPLAINED DYSPNEA HAD AN
APPROPRIATE WORK-UP,
NONDIAGNOSTIC LUNG BIOPSY, WHAT
YOU SEE IS THERE'S WHAT'S
DESCRIBED AS HYPERTENSIVE
VASCULOPATHY AS WELL AS FIBROSIS
OF AIRWAYS, PA RINK MA AND
PLEURA, AND I THINK THE
INTERESTING ASPECTS OF THIS, YOU
LOOK AT CLUSTER ONE IS
NONDEPLOYED INDIVIDUALS,
CLUSTERED TOGETHER THAT'S SORT
OF REASSURING, THERE'S SOME
INDIVIDUALS WHO HAD THIS POST
DEPLOYMENT RESPIRATORY SYNDROME
CLUSTERED WITH PULMONARILY --
PATIENTS AND MOST OF THEM
CLUSTERED AS A UNIQUE ENTITY,
FIVE OF THOSE WENT ON TO HAVE
CATH ASSESSMENT, THREE OUT OF
FIVE OF WHOM WERE ULTIMATELY
DIAGNOSED WITH CLINICAL DPIEG
NOTICES OF PH.
SO -- DIAGNOSIS OF PH.
THIS IS A NOVEL ENTITY OF POST
DEPLOYMENT RESPIRATORY SYNDROME
WHICH AT LEAST IN THESE
INDIVIDUALS WASN'T A STRONG OR
OVERT CAUSE OF PULMONARY
HYPERTENSION PER SE BUT
CERTAINLY LED TO VASCULOPATHY ON
HISTO PATHOLOGY.
NEXT SLIDE.
SO SOME MORE OBSERVATIONAL DATA
IN THE VA POPULATION WHICH I'LL
SKIP OVER, BUT AGAIN, BURN PIT
EXPOSURE IS AN EMERGING RISK
FACTOR FOR CARDIOPULMONARY
DISEASE.
I'LL END ON THE NEXT SLIDE,
WHICH REALLY MIELTS UNDER
RECOGNITION AMONG VETERANS AND R
RECOGNITION AMONG U.S. VETERANS,
PROBABLY TRUE IN MOST OF OUR
MEDICAL SYSTEMS, FROM ABOUT A
DECADE AGO, FROM DR. MARON,
SHOWING 340 VETERANS WITH SEVERE
PULMONARILY HYPERTENSION BY
ECHO, PASP GREATER THAN 60,
RATES OF DIAGNOSTIC TESTING WERE
FAIRLY LOW AS YOU CAN SEE ON THE
RIGHT, ABOUT HALF GOT PFT'S,
ABOUT A THIRD GOT RIGHT HEART
CATHS AND THERE ARE REASONS WHY
SOME OF THESE INDIVIDUALS MAY
NOT GET A COMPLETE WORK-UP BUT I
THINK THE MOST STRIKING IS IF
YOU ADVANCE ON THIS SLIDE, THAT
ONLY 17 PERCENT OF THESE
INDIVIDUALS HAD PULMONARY
HYPERTENSION LISTED IN THE
PROBLEM LIST AND CONSIDERING
THAT A PASP OF GREATER THAN 60
CONSIDERING SYSTEMIC BLOOD
PRESSURE OF GREATER THAN 200
WHICH I SUSPECT WOULD SHOW UP ON
THE PROBLEM LIST OF ALL OF THESE
PATIENTS.
ADVANCE PLEASE.
THEN IF YOU LOOK AT THE
INDIVIDUALS WHO HAD PH BY ECHO
AND CROSS-REFERENCE THAT WITH
THE PRESENCE OF A CODE FOR PH
ONLY ABOUT 18 PERCENT OF
PATIENTS WITH PH BY ECHO
ACTUALLY HAD A CODE.
SO FURTHER EVIDENCE IT'S UNDER
RECOGNIZED IN THIS POPULATION
BUT FURTHER EVIDENCE THAT CODES
ARE NOT PARTICULARLY HELPFUL FOR
STUDYING CARDIOVASCULAR DISEASE
IN THESE PATIENTS.
SO NEXT SLIDE AND I'LL END
THERE.
I TRIED TO DEFENSE YOU THAT
HOMELESSNESS IS A CAUSE OF THE
CAUSE OF PULMONARY VASCULAR
DISEASE, ALTHOUGH I CONFESS I
DON'T HAVE ANY DIRECT DATA OF
THAT AND THEN THAT VETERANS
COMPRISE A LARGE AND VULNERABLE
POPULATION WITH RESPECT TO
PULMONARY HYPERTENSION RISK.
>> THANKS VERY MUCH, EVAN, I
APPRECIATE THAT TALK.
IT WAS WONDERFUL AND INSIGHTFUL.
I LEARNED A FEW THINGS FOR SURE.
I THINK FOR THE SAKE OF TIME,
DR. LEOPOLD, DID YOU HAVE A
QUESTION?
>> WELL, IF WE'RE STRETCHED FOR
TIME, WE'LL WAIT UNTIL THE
DISCUSSION.
>> LET'S MAYBE MOVE ON TO OUR
LAST TALK OF THE DAY, AND THEN
WE'LL HAVE SOME TIME FOR
DISCUSSION.
I'M SURE THERE WILL BE QUITE A
FEW QUESTIONS ON THESE SUBJECTS.
OUR NEXT SPEAKER IS DR. RACHEL
GOLD.
SHE IS TALKING ON SOCIAL
DETERMINANTS OF HEALTH SCREENING
AND REFERRALS: WHAT DO WE KNOW?
SHE IS, TO REITERATE, SHOWS A
SENIOR INVESTIGATOR AT KAISER
PERMANENTE, SHE'S ALSO LEAD
RESEARCH SCIENTIST AND PROGRAM
DIRECTOR AT THE NONPROFIT OCHIN.
GO AHEAD, RACHEL.
>> GREAT, THANKS SO MUCH FOR
HAVING ME.
I HOPE EVERYONE IS STILL AWAKE.
I KNOW YOU'VE ALL HAD A LONG DAY
OF TALKS, BUT I THINK THIS IS A
NICE ONE TO END WITH BECAUSE
THERE'S BEEN SO MUCH INTERESTING
DISCUSSION ABOUT THE WAY THAT
SOCIAL DETERMINANTS OR I PREFER
THE TERM SOCIAL RISKS, AFFECT
HEALTH AND CHRONIC DISEASE
MANAGEMENT, BUT I'M GOING TO
TALK ABOUT WHAT DO WE KNOW ABOUT
WHAT WE CAN DO TO MITIGATE THOSE
IMABLGHTS.
IMPACTS.
NEXT, PLEASE.
I'M NOT GOING TO SPEND TOO MUCH
TIME ON THE NEXT COUPLE SLIDES.
WE'VE HAD A NUMBER OF SPEAKERS
TODAY ALREADY COVER THIS.
AGAIN I PREFER THE TERM SOCIAL
RISKS MYSELF.
I THINK IT'S IMPORTANT TO
DIFFERENTIATED BETWEEN THOUGH
INSTEAD OF VERY DIRECTLY DRIVEN
BY POVERTY AND THOSE THAT ARE
NOT, IT CAN ALSO MEAN
NEIGHBORHOOD FACTORS AS WELL AS
INDIVIDUAL LEVEL FACTORS.
SINCE SO MUCH TIME HAS BEEN
SPENT ON THIS ALREADY, I DON'T
THINK YOU GUYS NEED ME TO
REITERATE THIS.
SO I'LL GO ON.
NEXT, PLEASE.
YOU ALL MAY HAVE SEEN THIS
BEFORE, BUT JUST VERY BROADLY
SPEAKING, THERE'S A LOT OF
EVIDENCE THAT MOST HEALTH
OUTCOMES ARE IN FACT DRIVEN BY
SOCIAL CONTEXT, SOCIAL RISKS,
AND THAT CLINICAL CARE IN A LOT
OF CASES IS REALLY ONLY TAKES
CARE OF A VERY SMALL PERCENTAGE
OF HEALTH OUTCOMES.
AGAIN, AS HAS BEEN DISCUSSED,
THE SOCIAL RISKS AFFECT SOCIAL
CIRCUMSTANCES, BEHAVIORS, HEALTH
BEHAVIORS, SOME ENVIRONMENTAL
EXPOSURES AND OF COURSE ACCESS
TO HEALTHCARE.
WE'RE GOING TO TALK A LITTLE BIT
THOUGH ABOUT EVEN HOW WHEN YOU
HAVE ACCESS TO HEALTHCARE, IT
DOESN'T ALWAYS MAKE A
DIFFERENCE.
I'LL GO ON IN A MOMENT.
NEXT, PLEASE.
I'M GOING TO GET A LITTLE MORE
INTO THIS.
I KNOW IT'S BEEN TOUCHED ON SOME
ALREADY TODAY BUT I THINK IT'S
FINANCIAL CORRESPONDENT
REITERATE THESE BECAUSE IT'S
REALLY IMPORTANT TO UNDERSTAND
THESE PATHWAYS.
SO ONE WAY THAT SOCIAL RISKS
AFFECT HEALTH IS BY FOLKS HAVE
LESS ACCESS TO AFFORDABLE CARE.
I DO MOST OF MY RESEARCH IN
PRIMARY CARE COMMUNITY HEALTH
CENTERS, IN WHICH PATIENTS ARE
EITHER UNINSURED OR PUBLICLY
INSURED AND PUBLIC INSURANCE IS
LIKE ADEQUATE BUT NOT GREAT.
IT INCREASES EXPOSURES TO RISKS,
AGAIN, HAS BEEN DISCUSSED SOME,
STRESS, DISCRIMINATION, UNSAFE
EMPLOYMENT, LESS HEALTH LI
LITERACY, MORE POTENTIAL FOR
ADVERSE CHILDHOOD EVENTS, ALL OF
WHICH CAN AFFECT HEALTH IN
ADULTHOOD.
THE STUFF THAT I FIND REALLY
IMPORTANT I THINK AND IN THE
CONTEXT ESPECIALLY OF CHRONIC
DISEASE MANAGEMENT IS HOW SOCIAL
RISKS IMPACT INDIVIDUAL
PATIENTS' ABILITY TO ENGAGE IN
HEALTHY BEHAVIORS, TO ADHERE TO
CARE PLANS, TO ACT ON CARE
RECOMMENDATIONS, AND AS WAS
NOTED BEFORE, THESE ELEMENTS CAN
INTERACT AND BE CUMULATIVE, SO
LET'S MOVE ON BECAUSE I THINK
YOU GUYS WILL REALLY WANT TO
HEAR ME TALK ABOUT HOW WE CAN
MITIGATE THIS STUFF.
NEXT, PLEASE.
OKAY.
I AM GOING TO TALK A LITTLE BIT
OF DETAIL ABOUT HOW CHRONIC
DISEASE RISK MANAGEMENT IS
AFFECTED BY HAD SOCIAL RISKS,
AND I'M A PVD PERSON, BUT I'M
BETTING THAT THESE VERY SAME
PATHWAYS DO AFFECT PVD.
MOST NUMBERS MORE FOCUSED ON
DIEBILITIES THAN CARDIOVASCULAR
DISEASE SPECIFICALLY BUT HERE IS
HOW THIS STUFF WORKS.
MANY CHRONIC DISEASE RISK
FACTORS ARE MANAGEABLE.
WE CAN MANAGE THEM.
FOR EXAMPLE, HYPERTENSION, WITH
CLINICAL AND BEHAVIORAL
INTERVENTIONS, MEDICATIONS,
DIET, EXERCISE, MOST OF THE
TIME, NOT ALL THE TIME, BUT MOST
OF THE TIME, THE RISK CAN BE
MANAGED IF THE PATIENT CAN
ENGAGE IN THOSE BEHAVIORS.
BUT SOCIAL RISKS DIRECTLY AFFECT
PEOPLE'S ABILITY TO DO THAT.
SO IF SOMEONE DOESN'T HAVE
AFFORDABLE CARE, FIRST OF ALL
THEIR DISEASE RISK MAY NOT BE
IDENTIFIED, IT'S CERTAINLY NOT
BEING MONITORED REGULARLY, IF
THEY HAVE TRANSPORTATION
INSECURITY, IT BECOMES HARD
TO -- TEN VISITS, MAYBE IT'S --
HARD TO ATTEND VISITS, MAYBE
IT'S HARD TO FILL PRESCRIPTIONS.
EVEN IF YOU DO HAVE A STATE
MEDICAID OFFICE THAT WILL PAY
YOUR TRANSPORTATION THAT'S
USUALLY TO THE MEDICAL OFFICE
AND NOT NECESSARILY TO FILL A
PRESCRIPTION AND THAT CAN BE A
REAL PROBLEM FOR PEOPLE THAT
HAVE TRANSPORTATION BARRIERS.
ANOTHER PLACE TRANSPORTATION
BARRIERS REALLY PLAYS OUT AND
ENTER PLAYS WITH OTHER SOCIAL
RISKS FOR EXAMPLE IS, YOU KNOW,
IT'S ALL WELL AND GOOD TO REFER
A PATIENT WITH FOOD INSCRURT TO
A FOOD BANK BUT THEY NEED TO GO
BACK OVER AND OVER, YOU DON'T
JUST DID TO THE FOOD BANK ONCE,
AND THEN AGAIN, IF YOU DON'T
HAVE TRANSPORTATION, THEN THAT
BECOMES NOT REALLY A SOLUTION.
HOUSING FOOD AND FINANCIAL
INSECURITY CAN ALL MAKE IT HARD
TO EAT A HEALTHY DIET, HARD TO
GET EXERCISE, OTHER NEEDS ARE
PRIORITIZED WHICH MAKES A LOT OF
SENSE, AND AGAIN CAN IMPEDE
ABILITY TO PAY FOR MEDICATIONS
EVEN WHEN THERE'S A VERY LOCO
PAY.
SO OVER-- LOW CO-PAY.
OVERALL PATHWAY GOES LIKE THIS,
LOWER INCOME, LESS THIS SEASON K
DRIVES SOCIAL RISKS, SOCIAL
RISKS HAMPERS A PATIENT'S
ABILITY TO ENGAGE IN PREVENTIVE
BEHAVIORS AND OTHER
INTERVENTIONS, LEADS TO
UNMANAGED CHRONIC DISEASE AND
POOR OUTCOMES AND BETTING
ANYTHING THAT PATHWAY IS THE
SAME FOR PVD AS IT IS FOR
HYPERTENSION AND DIABETES.
NEXT, PLEASE.
OKAY.
AND I MENTIONED BEFORE THAT THIS
STUFF STILL HAPPENS, ACCESS TO
HEALTHCARE IS IMPORTANT, BUT
EVEN WHEN PATIENTS HAVE ACCESS
TO HEALTHCARE, TO DISEENT
QUALITY HEALTHCARE, IT -- DECENT
QUALITY HEALTHCARE, IT DOESN'T
SOLVE THE PROBLEM BY ITSELF.
THIS IS A STUDY FROM A COUPLE OF
YEARS AGO WHERE WE LOOKED AT
PATIENTS IN COMMUNITY HEALTH
CENTERS AND PRIMARY CARE
COMMUNITY HEALTH CENTERS AND
PUBLIC SAFETY NET OF PRIMARY
CARE WITH DIABETES AND WE LOOKED
AT WHETHER THEY HAD
TRANSPORTATION, HOUSING OR FOOD
INSECURITY IF THEY WERE MORE OR
LESS LIKELY TO BE UP TO DATED ON
THEIR DIABETES CARE AND THEN IF
THEY WERE, WERE THEY MORE OR
LESS LIKELY TO HAVE THEIR
DIABETES MANAGED AND WHAT WE
FOUND WAS THAT FOLKS WITH SOCIAL
RISKS HAD THE SAME QUALITY OF
CARE.
GOT THEIR SCREENINGS ON TIME AT
THE SAME LEVEL AS THOSE WHO DID
NOT REPORT THESE RISKS.
SO THEY'RE GETTING GOOD QUALITY
CARE, BUT EVEN AMONG THOSE UP TO
DATE ON THEIR PREVENTIVE CARE,
THOSE WITH FOOD INSECURITY HAD
LOWER RATES OF CONTROLLED A1C,
THOSE WITH TRANSPORTATION
INSECURITY HAD LOWER RATES OF
CONTROL, ALL THE BIOMARKERS WE
LOOKED AT, A1C, BLOOD PRESSURE,
LIPIDS, AND THOSE WITH HOUSING
INSECURITY NO DIFFERENCES.
WE THOUGHT THAT WAS REALLY
FASCINATING.
I WILL SAY THERE'S QUITE A
GROWING BODY OF RESEARCH SHOWING
THAT TRANSPORTATION BARRIERS ARE
ONE OF THE BIGGEST DRIVERS
COMPARED TO FOOD AND HOUSING,
ALL IMPORTANT, BUT
TRANSPORTATION IS MORE IMPORTANT
THAN -- MAYBE MORE IMPORTANT
THAN THE OTHERS.
DON'T TAKE ME ON THAT AS GOSPEL,
BUT THERE'S A PATTERN THAT'S
EMERGING IN THE LITERATURE AS I
PERCEIVE IT.
SO REALLY IMPORTANT TO NOTE HERE
THAT GUIDELINE IN IMPORTANT CARE
DOES NOT NECESSARILY GUIDE
OUTCOMES IF PATIENT HAS SOCIAL
RISKS.
WHAT CAN HEALTHCARE PROVIDERS DO
ABOUT THIS?
THERE'S A WONDERFUL 2019
NATIONAL ACADEMIES REPORT THAT
REALLY SUMMARIZED WHAT THEY CALL
THE FIVE A'S OF SOCIAL CARE
INTEGRATION OR FIVE A'S, FIVE
DIFFERENT THINGS THAT HEALTHCARE
PROVIDERS CAN DO TO TRY AND
MITIGATE HOW SOCIAL RISKS AFFECT
HEALTH OUTCOMES, AND SOME OF THE
THEM ARE FOCUS ODD COMMUNITY.
THE FIRST ONE IS AWARENESS,
FIRST AVE., YOU'VE GOT TO KNOW
WHAT'S GOING ON, THAT APPLIES TO
BOTH HEALTHCARE ACTIVITIES AND
COMMUNITY FACING ACTIVITIES, AND
I'LL TALK ABOUT THE ACTIVITIES
FOCUSED ON THE HEALTHCARE
SETTING BUT I JUST WANT TO NOTE
THAT THERE ARE COMMUNITY LEVEL
ALIGNMENT AND ADVOCACY ELEMENTS
AS WELL.
BUT FOR INDIVIDUAL PATIENTS,
WHAT CAN YOU DO IF YOU'RE A
PROVIDER, ONE WE TALK ABOUT IS
ADJUSTMENTS OR SOCIAL RISK
INFORMED CARE AND THAT INVOLVES
ADAPTING THE CARE PLAN TO
ACCOMMODATE A PATIENT'S SOCIAL
RISK.
THE OTHER IS ASSISTANCE, WHICH
IS TRYING TO MITIGATE SOCIAL
RISK ITSELF, EITHER GIVING
PATIENTS FOOD OR REFERRING THEM
ON A FOOD BANK ET CETERA, ET
CETERA, REFERRING THEM TO SOCIAL
SERVICES.
AND THE WORDS ADJUSTMENT AND
ASSISTANCE AND AWARENESS I'LL
USE A LOT THROUGHOUT THIS TALK,
SO AWARENESS AGAIN IS DO YOU
KNOW THIS IS GOING ON,
ADJUSTMENT IS ADAPTING THE CARE
PLAN TO MAKE IT SO THE PATIENT
IS MORE ABLE TO FOLLOW IT,
ASSISTANCE IS ACTUALLY TRYING TO
MITIGATE SOCIAL RISK ITSELF
THROUGH COMMUNITY REFERRAL OR
SOME OTHER METHOD.
NEXT, PLEASE.
OKAY.
SO WE TALKED ABOUT AWARENESS.
THE POINT I WANT TO MAKE HERE IS
BECAUSE IT'S SOMETHING I SEE
COME UP OVER AND OVER AGAIN AND
I SAW A LITTLE BIT OF IT TODAY,
FOLKS CAN I JUST USE COMMUNITY
LEVEL DATA, CAN I JUST USE
NEIGHBORHOOD CHARACTERISTICS TO
ASSUME I'M AWARE OF WHAT WI
GIVEN PATIENT NEEDS, AND THE
ANSWER IS NO.
THEY DO NOT ALIGN.
IT'S LIKE FLIPPING A COIN,
LOOKING AT A PATIENT'S COMMUNITY
LEVEL DATA TO UNDERSTAND WHAT
THEIR INDIVIDUAL NEEDS ARE.
A COUPLE DIFFERENT STUDIES HAVE
SHOWN THIS NOW.
NOW, THOSE COMMUNITY LEVEL DATA
ARE ABSOLUTELY USEFUL FOR
ALIGNMENT, FOR ADVOCACY, FOR
THINKING ABOUT WHAT'S GOING ON
AT THE COMMUNITY LEVEL BUT IN
TERMS OF POINT OF CARE, PATIENT
NEEDS, YOU HAVE TO ASK THEM WHAT
IS GOING ON.
AND I THINK IT'S REALLY
IMPORTANT THAT I WOULD LIKE TO
REALLY HAMMER THAT POINT ON
BECAUSE I SEE ALL THE TIME THIS
SORT OF INTEREST IN WE'LL JUST
USE COMMUNITY LEVEL DATA BUT YOU
REALLY CAN'T.
NEXT PLEASE.
SO THAT MEANS TO HAVE EFFECTIVE
AWARENESS PROCEDURES YOU REALLY
NEED TO SCREEN PATIENTS, YOU
HAVE TO ASK THEM WHAT'S GOING
ON, BUT THERE'S HUGE VARIATION
IN HOW MUCH THAT IS HAPPENING.
AGAIN IN A NATIONAL NETWORK WHEN
WE CONDUCTED IT OVER ABOUT IT'S
ABOUT 2,000 CLINICS NOW IN THE
NETWORK, WE HAVE ALMOST THREE
AND A HALF MILLION SOCIAL RISK
SCREENINGS EXPUCTD THIS IS AGAIN
IN SEVERAL -- CONDUCTED AND THIS
IS AGAIN IN SIX MILLION PATIENTS
BUT ONLY 20 PERCENT OF THE
PATIENTS HAVE EVER BEEN SCREENED
SO THERE ARE SOME CLINICS OR
CARE ORGANIZATIONS THAT ARE
DOING A GREAT JOB IN SCREENING
LOTS OF THEIR PATIENTS AND SOME
THAT HAVEN'T EVEN STARTED.
THERE'S TONS OF VARIATION HERE,
AND WHAT'S HAPPENING SOMETIMES
IS THAT FOLKS IT'S KIND OF
HAPPENING AT HOCK LIKE YOU'VE
GOT ONE CARE TEAM THAT'S REALLY
EXCITED ABOUT IT BUT THEN NO ONE
ELSE IS SCREENING FOR SOCIAL
RISKS AND REALLY THE BIG TAKE
HOME POINT I WANT TO MAKE IS
THERE'S A TON OF VARIATION, IT'S
ALMOST INCREASE IML THIS IS
HAPPENING AND -- INCREASINGLY
THIS IS HAPPENING AND THOSE
RATES ARE GOING UP BECAUSE
THERE'S MORE AND MORE
INITIATIVES SUPPORTING OR
INCENTIVIZING THE SCREENING BUT
IT'S STINLT HAPPENING ANYWHERE
NEAR AT THE -- IT'S STILL NOT
HAPPENING ANYWHERE NEAR AT THE
LEVEL WE WANT IT TO HAPPEN AND
IT'S REALLY INCONSISTENT.
THIS IS IN PRIMARY CARE I SHOULD
NOTE.
WHY IS THAT?
BECAUSE THERE ARE SUBSTANTIAL
BARRIERS TO IMPLEMENTING
SCREENING TO GET TO AWARENESS.
THOSE IDENTIFIED AT THAT
NATIONAL ACADEMIES REPORT AND
MANY OTHERS SINCE HAVE SHOWN THE
SAME THING AND I INTENTIONALLY
PUT A LOT OF STUFF ON THIS SLIDE
SO I REALLY WANT TO MAKE SURE
THAT THERE ARE LOTS OF BARRIERS
HERE.
CLINICS GOT COMPETING NEEDS,
COMPETING INITIATIVES, DON'T
HAVE ENOUGH RESOURCES TO DO IT,
THIS IS VERY IMPORTANT.
OH, I ALREADY KNOW MY PATIENTS
NEEDS, OH, MY STAFF DON'T FEEL
COMFORTABLE ASKING, WHY SCREEN
IF I CAN'T REFER, PEOPLE GET
VERY URVELG SOMETIMES ASKING
PEOPLE ABOUT THESE IMPORTANT
PARTS OF THEIR LIVES IF THEY
DON'T HAVE A SOLUTION TO
PROVIDE, WHICH I GET BUT THEN
YOU GET YOURSELF IN A PICKLE.
ROLES, SHOULD THE CLINICIAN BE
DOING T NO, DEFINITELY SUPPORT
STAFF, SMALL CLINICS, MAYBE THE
CLINICIAN COULD DO T THIS NEEDS
TO BE DEFINED.
THERE'S TENSION AROUND WE HEAR
THIS OVER AND OVER IN MY
RESEARCH THIS IS WHAT I STUDY
BETWEEN CLINICS LOOK THE STAFF
WHO ARE ASKING THE QUESTIONS
ABOUT THE SOCIAL RISKS ARE LIKE
I WANT TO TALK TO THE PATIENTS,
I WANT TO HAVE A CONVERSATION, I
DON'T WANT TO BE FILLING OUT A
CHECK BOX ABOUT LIKE OH HOUSING
INSECURITY, CHECK, THAT FEELS
TECIALT -- THAT FEELS TERRIBLE,
RIGHT?
STAFF TURNOVER, NEED TO HAVE THE
RIGHT TRAINING, HR IS NOT VERY
GOOD AT SCREEN DOCUMENTING
SCREENING RESULTS AND SO FORTH.
THESE ARE SOME OF THE REASONS
WHY WE HAVE BARRIERS TO
SCREENING.
NEXT PLEASE.
I'LL JUST QUICKLY THE RESULTS OF
A STUDY THAT MY TEAM DID ON HOW
CAN YOU SUPPORT AGAIN PRIMARY
CARE COMMUNITY CLINICS IN
IMPLEMENTING SOCIAL RISK
SCREENING, LONG STORY SHORT, WE
GAVE CLINICS SIX MONTHS OF
PERSONALIZED TECHNICAL SUPPORT,
EHR TOOLS CUSTOMIZED TO BE USED
FOR SOCIAL RISK SCREENING, COACH
WALK THEM THROUGH FIVE STEPS
SHOWN HERE ON THE RIGHT, WE MET
WITH THEM TWICE A MONTH FOR SIX
MONTHS, PEER TO PEER LEARNING,
EVERYTHING THAT THE LITERATURE
SUGGESTS WOULD BE HELPFUL WE
TRIED TO PROVIDE TO THE CLINICS
IN THIS STUDY TO SEE WHETHER
THAT LEVEL OF SUPPORT WOULD
IMPROVE THEIR SCREENING LEVELS.
NOW, I WILL NOTE THAT THE
PANDEMIC HIT RIGHT IN THE MIDDLE
OF THIS STUDY, WHICH I'M SURE
ANY OF YOU WHO WERE DOING ON THE
GROUND RESEARCH DURING THE
PANDEMIC UNDERSTAND HOW MUCH
THAT AFFECTED RESULTS.
NEXT PLEASE.
BUT THE OVERALL FINDING HERE,
OUR OVERALL FINDING FROM THIS
STUDY WAS THAT WHILE THE
SCREENING DID SIGNIFICANTLY
INCREASE DURING THE INTERVENTION
PERIOD COMPARED TO
PREINTERVENTION, THAT IMPACT WAS
NOT SUSTAINED AFTER THAT SICK
MONTHS OF INTENSIVE SUPPORT.
WE SAW NO DIFFERENCE IN REFERRAL
RATES AT ALL, THIS WAS A COUPLE
YEARS AGO, SO THOSE WERE HARDER
TO DO THEN, BUT THEY'RE STILL
NOT EASY.
I'M SURE IF WE SHOULD HAVE
PROVIDED MORE LONGER MORE THAN
SIX MONTHS TO FOLKS, MAYBE WE
DIDN'T SOMEHOW ADDRESS THE
BARRIERS FOR SUSTAINED
IMPLEMENTATION.
I THINK THE TAKE HOME HERE IS
THAT COMMUNITY CLINICS
ESPECIALLY IN PRIMARY CARE
CLINICS IN GENERAL THAT DON'T
HAVE A LOT OF RESOURCES ARE
GOING TO REALLY STRUGGLE TO
CONDUCT SOCIAL RISK SCREENING IF
THEY'RE NOT GIVEN REALLY
SUBSTANTIAL SUPPORT AND
IMPLEMENTING IT AS A PRACTICE.
IT IS NOT EASY TO IMPLEMENT.
IT IS ASKING A LOT FROM CLINICS
TO DO, ESPECIALLY BECAUSE OF
THIS ISSUE AROUND REFERRAL AND
FOLKS NOT WANT TO GO AND
SOMETHING THAT THEY'RE NOT SET
UP TO SUPPORT.
BUT WE'LL TALK ABOUT THAT IN A
SECOND.
OKAY.
NEXT PLEASE.
OKAY.
I JUST WANTED TO GIVE YOU JUST A
RESOURCE HERE IN CASE THIS IS OF
USE.
WE DID FIND AGAIN THAT THESE
CLINICS DO FACE THESE REAL
BARRIERS TO IMPLEMENTING THIS
WORK, BUT WE DO HAVE AN
IMPLEMENTATION GUIDE THAT WE
MADE AVAILABLE THROUGH THE
NETWORK SIREN NETWORK, SOCIAL
RESEARCH INTERVENTION, YOU'LL
LOVE THEIR WEBSITE, IT IS AN
ABSOLUTE GOLD MINE OF
INFORMATION, WE HAVE A VERY
PRACTICING MACTD APPLIED
IMPLEMENTATION GUIDE HERE THAT
WE THINK CAN BE USED ACROSS
SETTINGS BUT WAS DESIGNED FOR
PRIMARY CARE, IT'S AVAILABLE
RKTS IT'S FREE, PLEASE USE IT.
NEXT, PLEASE.
LY JUST SECOND DOWN, JUST WALK A
GIVEN CARE PROVIDER CLINIC OR
SEGHTD STEP BY STEP THROUGH WHAT
THEY NEED TO DO TO PROVIDE
SOCIAL SCREENING, PROVIDES A LOT
OF RESOURCES.
ACCOUNTABLE HEALTH COMMUNITIES
PROJECT WAS A NATIONAL PROJECT
LED BY CMS SAME SET OF
QUESTIONS, WHAT IF WE PROVIDE
MONEY TO CLINICS TO HELP THEM
CONDUCT SOCIAL RISK SCREENING,
AND THEY FOUND THAT THE THINGS
THAT WORKED WERE A CULTURALLY
TAILORED APPROACH TO MAKE SURE
THERE WAS TRUST AND PATIENT
ENGAGEMENT, THIS RELATIONAL
PIECE BETWEEN THE PERSON ASKING
ABOUT THE SOCIAL RISKS AND THE
PATIENT, USING SCREENING DATA TO
DRIVE IMPROVEMENT IN THEIR
SCREENING RATES, TRYING
DIFFERENT MODALITIES OF GETTING
THE PATIENT OF DOING THE
SCREENING, BECAUSE SOMETIMES
DOING IT BY TEXT OR E-MAIL OR
PATIENT PORTAL MIGHT BE A LITTLE
MORE COMFORTABLE FOR FOLKS THAN
DOING IT IN PERSON, IT'S MORE
EFFICIENT, HAVING A DEDICATED
SCREENER ROLE WAS HELPFUL AT A
CLINIC, INTEGRATING THE
SCREENING INTO EXISTING
WORKFLOWS IF THAT'S HOW YOU WANT
TO DO IT, TALKING ABOUT WHAT IS
THE IMPACT OF SCREENING, THAT'S
REALLY IMPORTANT, WE TALK ABOUT
THAT IN THAT GUIDEBOOK I SHARED
WITH YOU AND MAKING SURE THERE'S
A WAY FOR THE TEAM TO REALLY
CONNECT ABOUT WHAT THEY'RE DOING
SO I THINK THAT WAS AN
INTERESTING PARALLEL TO THE
STUDY WHERE WE WERE LIKE WHAT IF
WE JUST PROVIDE REALLY INTENSIVE
ONE ON ONE SUPPORT AND THESE
GUYS WHAT IF WE JUST PROVIDE
MONEY AND WE'LL SEE WHAT
HAPPENS.
NEXT, PLEASE.
SO ASSISTANCE I'VE TALKED ABOUT,
TALKING ABOUT REFERRALS, THAT'S
REALLY WHAT WE MEAN BY
ASSISTANCE, CAN YOU REFER A
PATIENT TO HOUSING SUPPORT, ET
CETERA, ET CETERA, AND HERE IS
WHAT THE LITERATURE SAYS ABOUT
THE IMPACT OF ASSISTANCE
INTERVENTIONS, RIGHT?
THAT THESE INTERVENTIONS BE IT
THE CLINICS PROVIDING AN
INTERNAL SOMETHING WHERE THE
CLINICS PROVIDING TRANSPORTATION
OR AN EXTERNAL REFERRAL WHERE
WE'RE GETTING YOU IN TOUCH WITH
A MEDICAL SERVICE
CAN MODESTLY IMPROVE HEALTH
OUTCOMES.
STUDIED IN 2017 BY GOTTLIEB ET
AL. EVIDENCE REVIEW FOUND AS
ANSWER ASSOCIATED WITH IMPROVED
WITH A NUMBER OF THESE METRICS
AND ANOTHER STUDY FOUND NO
SIGNIFICANT IMPROVEMENTS AND A
MORE RECENT REVIEW IN HEALTH
EQUITY ALSO FOUND VERY MIXED
EVIDENCE ON HOW THESE -- ON THE
IMPACT OF ASSISTANCE EFFECT.
THIS IS FASCINATING, RIGHT,
BECAUSE WE'VE BEEN, THERE'S A
TON OF EMPHASIS ON LIKE, WELL,
GET PATIENTS REFERRED BUT
THERE'S NOT A LOT OF EVIDENCE ON
IT WORKING OR IT'S VERY MIXED.
SO WHAT MAKES AN ASSISTANCE
INTERVENTION EFFECTIVE, WE HAVE
A LOT TO LEARN HERE.
ONE THING THAT DOES SEEM TO BE
TRUE IS THAT HAVING A NAVIGATOR
CAN REALLY HELP, SOMEONE WHOSE
JOB IT IS TO SAY TO A PATIENT
HEY WE GAVE YOU THIS INFORMATION
ABOUT A FOOD BANK, CAN I HELP
YOU MAKE A CONNECTION, THAT
EXTRA SET OF HELPING HANDS CAN
MAKE A DIFFERENCE.
BUT AGAIN, NONE OF THIS IS
MAKING A BIG DIFFERENCE AND
THAT'S REALLY IMPORTANT.
NEXT.
JUST THE ASSUMPTION, THIS GETS
TO WHERE I'M GOING WITH THIS IS
THE ASSUMPTION OF ALL THIS
EMPHASIS ON MAKING THESE
REFERRALS, THIS ASSISTANCE
INTERVENTIONS IS THAT YOU IF
SCREEN FOR SOCIAL RISKS AND
REFER PATIENTS TO SERVICES AND
THE PATIENTS ARE GOING TO GET
THE SERVICES, THEY'RE GOING ON
RESOLVE THE RISKS AND THAT'S
GOING TO LEAD TO IMPROVED HEALTH
BUT WE DON'T KNOW THAT'S TRUE,
THERE'S NOT STRONG EVIDENCE FOR
SUPPORTING THIS PATHWAY, WHAT
THERE IS EVIDENCE FOR IS A FAR
MORE COMPLEX PATHWAY THAT REALLY
INVOLVES THE PATIENT AND CARE
TEAM RELATIONSHIP.
OH, I MENTIONED THE NAVIGATION.
LET'S GO TO THE NEXT SLIDE
BECAUSE THIS IS A NEXT SLIDE
FROM GOTLIEB OF THE ALL, WHAT IS
REALLY THE PATHWAY.
I WANT FOINT OUT HERE THE
IMPORTANCE -- POINTED OUT HERE
THE IMPORTANCE OF IMPROVING
EMOTIONAL SUPPORT, CONNECTING
PATIENTS WITH A NAVIGATOR, THE
PATIENT FEELS MORE CARED FOR,
THIS IS JUST A MORE COMPLEX SET
OF PATHWAYS THAN JUST CONNECTED
WITH SERVICES, THEY GET BETTER,
RIGHT?
THAT'S ONE OF THEM, BUT ANOTHER
IS THEY FEEL MORE SUPPORTED,
ANOTHER IS THAT THERE'S MORE
HEALTHCARE SERVICES ARE
ACCESSED, IT'S MUCH MORE COMPLEX
THAN JUST REFER AND HOPE.
AND I HIGHLY RECOMMEND THIS
PAPER.
IT'S VERY, VERY HELPFUL TO THINK
ABOUT WHAT WE'RE DOING RIGHT AND
WHAT WE'RE DOING WRONG.
NEXT, PLEASE.
OKAY.
AND GUESS WHAT?
THERE ARE BARRIERS TO
IMPLEMENTING THESE ASSISTANCE
REFERRALS, EVEN AS WE KNOW
THEY'RE NOT THAT GREAT, THERE'S
NOT MUCH ELSE OUT THERE RIGHT
NOW, THEY'RE KIND OF THE BEST
BAND-AID WE'VE GOT, BUT PATIENTS
WHO ARE OFFERED REFERRALS DON'T
ALWAYS WANT THEM.
MAYBE THEY'VE ALREADY TRIED
THEM, THERE'S A FEAR OF STIGMA,
DISCRIMINATION, ET CETERA, ET
CETERA, OUR TEAM FOUND THAT
ALMOST 80 PERCENT OF COMMUNITY
HEALTH CENTER PATIENTS WITH
REPORTED RISK DECLINED A
REFERRAL THEY WERE OFFERED AND
THAT RATE OF DECLINATION HAS
BEEN SHOWN BY OTHERS WITH A TON
OF VARIATION IN HOW OFTEN FOLKS
ARE WILLING OR WANT THAT
INFORMATION, WANT THE REFERRAL,
THIS IS REALLY IMPORTANT.
NEXT, PLEASE.
AND AGAIN, ONE OF THESE BIG
BARRIERS AS I THINK I ALLUDED TO
EARLIER IS SORT OF LIKE WELL,
OKAY, WE'RE TRYING AT THE TIME
GET PATIENTS TO CONNECT WITH A
SOCIAL SERVICE BUT ARE THE
RESOURCES AVAILABLE?
DO YOU HAVE A HOUSING -- WHERE I
LIVE, REFERRING PATIENTS TO
HOUSING SUPPORT THEY'LL BE ON A
WAITING LIST FOR A FEW YEARS.
DOES THAT ADDRESS THEIR NEED?
NOT IMMEDIATELY.
THAT'S IN A BIG CITY.
WHAT HAPPENS IF YOU'RE OUT IN A
MORE RURAL AREA?
THERE MAY NOT BE RESOURCES WITH
WHICH TO ADDRESS THE PATIENT'S
NEED, AND THEN AGAIN THERE'S
REAL COMPLEXITY AROUND LIKE WHO
DOES THE REFERRING AND WHEN.
UNLESS THERE'S SOME KIND OF
MEDICAID REIMBURSEMENT, AT LEAST
IN LOW-INCOME CLINICS, IF YOU
DON'T HAVE SOMEONE ON STAFF WHO
HAS GOT THE TIME TO DO IT, THEN
HOW -- IF IT'S NOT REIMBURSABLE,
IT'S BECOMING MORE REIMBURSABLE,
AND THAT'S GREAT, THAT WILL MAKE
A BIG DIFFERENCE I THINK, BUT
THAT HAS BEEN A BARRIER IN THE
PAST AND IT'S STILL NOT THE CASE
EVERYWHERE THAT THERE'S SOMEONE
PAYING THE STAFF TO DO THE
REFERRAL AND THE STAFF NEED TO
KNOW THE LOCAL COMMUNITY-BASED
ORGANIZATIONS, CBO'S, THEY NEED
TO KNOW -- AND THESE COMMUNITY
ORGANIZATIONS SOME OF THEM
CHANGE A LOT, RIGHT, SO THEY'VE
GOT TO HAVE AN UP TO DATE LIST.
I THINK I'M GETTING INTO MY NEXT
SLIDE.
PLEASE GO.
NEXT ONE, PLEASE.
OH, OKAY.
SO THAT GETS TO THE ISSUE OF
WELL HOW DO YOU MAKE SURE YOU
EVEN KNOW WHAT RESOURCES ARE
AVAILABLE.
A LOT OF FOLKS ARE INTERESTED IN
THESE SOCIAL SERVICE RESOURCE
LOCATORS AND THERE'S A
TECHNOLOGY THAT I THINK HAS A
LOT OF PROMISE IN HELPING TO
HAVE AN UPDATED SEARCHABLE LIST
AND SOMETIMES CONNECTIBLE
INTERFACE FOR CONNECTING FOLKS
WITH SOCIAL SERVICES BUT THEY'RE
NOT NECESSARILY CHEAP OR IF THEY
ARE CHEAP, THEY MAY NOT BE UP TO
DATE, SOMETIMES EVEN IF THEY'RE
NOT CHEAP, THEY'RE NOT UP TO
DATE AND WE'VE HEARD SOMETIMES
ONES WITH EHR SOMETIMES THEY
HAVE A LOT OF GLICHES, THERE'S
TOO MANY OPTIONS IN CASES, I
DON'T KNOW WHICH ONE TO GO WITH
AND COMMUNITY BASE THE
ORGANIZATIONS HAVE TO BE WILLING
TO ENGAGE RIGHT BECAUSE YOU'LL
HEAR PEOPLE SAYING I WANT TO
CLOSE THE LOOP ON SOCIAL SERVICE
REMPLEZ BUFORT YOU CAN'T CLOSE
THE LOOP UNLESS SOMEONE ON YOUR
TEAM CALLS THE PATIENT AND SAYS
DID YOU MAKE IT, DID YOU GET
THAT SERVICE, OR YOU'VE GOT TO
SOMEHOW ADDRESS THE BARRIERS OF
THESE COMMUNITY-BASED
ORGANIZATIONS THAT JUST LIKE
THEY MAY NOT HAVE TIME, WHAT ARE
THEY GETTING OUT OF IT IF YOU'RE
NOT PAYING THEM THEN WHY ARE
THEY GOING TO CLOSE THE LOOP?
THIS IS A BARRIER I'VE SEEN THIS
MULTIPLE SETTINGS IN MULTIPLE
SITUATIONS WHERE THE COMMUNITY
ORGANIZATIONS ARE JUST LIKE WHY
ARE YOU -- THIS IS NOT MY
PROBLEM, LIKE THEY'LL TAKE THE
PATIENTS BUT THEY DON'T FEEL
OBLIGATED TO CLOSE THIS LOOP,
AND THEN HOW DIST CLINIC KNOW
FLT PATIENT CLOSED THE LOOP?
SO THIS IS VERY COMPLEX.
NEXT H PLEASE.
I DO AGAIN HAVE SOME RESOURCES
TO OFFER YOU ON HOW TO IMPLEMENT
THESE KIND OF ASSISTANCE
REFERRALS.
ONE IS AGAIN FROM SIREN, THE
COMMUNITY RESOURCE REFERRAL
PLATFORM GUIDE, AGAIN THINKING
ABOUT THE DIFFERENT KINDS OF
SOCIAL SERVICE RESOURCE LOCATORS
AND ANOTHER IS IMPLEMENTATION
TOOLKIT FOR SOCIAL RISK
REFERRALS FOR PRIMARY CARE MY
TEAM RECENTLY COMPLETED AND MADE
AVAILABLE THROUGH SIREN AND THE
SHRINK RIGHT THERE AND THIS IS
AGAIN A VERY PRAGMATIC APPLIED
GUIDE TO THINKING ABOUT THE
DECISION YOU'LL MAKE AND WHAT
YOUR OPTIONS ARE IF YOU WANT TO
CONDUCT SOCIAL RISK REFERRAL
MAKING.
NEXT, PLEASE.
I REALLY WANT TO GET TO
ADJUSTMENT.
SO I'VE BEEN TALKING ABOUT
REFERRALS BUT THEN THERE'S ALSO
THIS IDEA OF ADJUSTMENT.
CAN YOU ADAPT THE CARE PLAN TO
MAKE IT MORE FEASIBLE FOR THE
PATIENT TO ADHERE TO THE CARE
PLAN?
GOT IT.
THANK YOU.
I'M RIGHT ON TIME.
ADJUSTMENTS MIGHT MEAN LIKE
MAKING SURE THAT THEY'VE GOT A
GENERIC MEDICATION THAT IS MORE
AFFORDABLE THAN A NONGENERIC,
MAKING SURE THEY'RE GETTING A
POLYPILL TO REDUCE THE CO-PAY,
CAN YOU MAIL THE PRESCRIPTION TO
THEIR HOME IF THEY HAVE
TRANSPORTATION BARRIERS, BUT IS
THAT A SAFE THING TO DO TO MAIL
IT TO THEIR HOME, LIKE WILL THEY
GET THE MEDS IF THEY'RE DROPPED
OFF ON THEIR DOOR, THERE'S
COMPLEXITY THERE.
IF THE PERSON HAS TRANSPORTATION
INSECURITY, CAN FOLLOW-UP CARE
BE VIA TELEHEALTH, DOES THE
PATIENT HAVE ACCESS TO
TELEHEALTH, WE'RE FINDING THAT
TELEHEALTH ACCESS IS LESS OF A
BARRIER THAN IT USED TO BE
BEFORE THE PANDEMIC BUT
NEVERTHELESS HAVE TO MAKE SURE
THAT'S AN OPTION.
FOR EXAMPLE IF THE PATIENT
DESCRNT A PLACE TO REFRIGERATE
THE MEDICATION YOU NEED TO MAKE
SURE YOU GIVE THEM A MEDICATION
THAT DOES NOT NEED TO BE
REFRIGERATED, IF THEY'RE FOOD
INSECURE AND THEY HAVE DIABETES
YOU NEED TO THINK ABOUT HOW MUCH
FOOD THEY'LL HAVE AT THE END OF
THE MONTH IF THEIR MONTHLY FOOD
BENEFIT RUNS OUT AND MAYBE HAVE
TOO MUCH INSULIN, YOU HAVE TO
THINK ABOUT THAT PIECE.
THERE IS SOME EMERGING EVIDENCE
THAT SAYS DO GET BETTER CLINICAL
OUTCOMES IF YOU MAKE THESE CARE
PLAN ADJUSTMENTS, MOSTLY WORK
DONE BY SHALLWEI NEXT R AT THE
UNIVERSITY OF CHICAGO BUT FOUND
ADJUSTMENTS ONLY HAPPENING LESS
THAN 25 PERCENT OF THE TIME IN
LOTS OF DIFFERENT SETTINGS.
SO HOW CAN YOU PRESENT SOCIAL
RISK INFORMATION IN A WAY THAT
DOES IMPROVE ADJUSTMENT
PROVISION, COULD WE USE TOOLS IN
THE EHR, MY TEAM IS RUNNING A
TRIAL RIGHT NOW ON A SET SET OF
EHR TOOLS WE DESIGNED WITH
COMMUNITY MEMBERS PILOTED IN
COMMUNITY CLINICS, REVISED TOOLS
ACCORDING TO THE PILOT CLINIC'S
INPUT AND I'LL TELL YOU RIGHT
NOW WHAT IS HAPPENING IS THAT NO
ONE IS USING TOOLS, EVEN THOUGH
WE DID EVERYTHING RIGHT.
THEY JUST DON'T, THEY'RE NOT
USING THEM.
SO THERE'S A LOT WE HAVE TO
FIGURE OUT ABOUT HOW TO REALLY
SUPPORT ADJUSTMENT OCCURRING.
NEXT, PLEASE.
I THINK IT'S MY LAST SLIDE, SO
IF YOU'RE ALL FALLING ASLEEP,
BEAR WITH ME.
YES, I THINK THIS IS THE LAST
ONE, OR NO, SECOND-TO-LAST.
SO JUST ANOTHER JUST POINTED
ABOUT ADJUSTMENT, IT'S KIND OF
INTERESTING THAT WHEN CLINICIANS
DO HAVE INFORMATION ABOUT THE
PATIENT'S SOCIAL RISKS, ONE
SURVEY THAT WE CONDUCTED FOUND
THAT AND THIS WASN'T A HUGE
NUMBER, BUT IT WAS STILL RIGHT
AT THE POINT OF CARE WHICH WAS
COOL, THAT THE CLINICIANS DID
REPORT THAT THE PATIENT SOCIAL
RISKS INFLUENCE -- POINT OF
INFLUENCED CARE ABOUT A THIRD OF
THE DISPIEM INTERESTING IN
CONVERSATION FROM THE PATIENT
ONLY ABOUT HALF THE TIME FROM
THE EHR SO OUR WHOLE FAMILY SIS
ON AWARE NGS AND GETTING THAT
DATA INTO EHR THAT MIGHT BE
USEFUL FOR REPORTING PURPOSES
BUT MAYBE THAT'S NOT THE WAY
THAT CARETAKERS WANT TO GET THAT
INFORMATION AND I THINK THIS IS
A REALLY IMPORTANT POINT TWHEAF
NOT DIALED IN YET.
LAST SLIDE, PLEASE.
WHAT DO WE STILL NEED TO KNOW?
WELL, THE ANSWER IS A LOT.
WE DON'T REALLY KNOW WHAT
PATHWAYS TO FOLLOW TO ENSURE
THAT SOCIAL RISK SCREENING AND
REFERLINGS LEAD TO IMPROVED
HEALTH OUTCOMES.
WE CAN MAKE A LITTLE IMPROVEMENT
BUNLT A BIG IMPROVEMENT AND A
LITTLE IMPROVEMENT IS MAYBE NOT
ENOUGH.
WHAT PREACHES TO ADDRESSING
SOCIAL RISKS ARE MOST EE FICTIVE
AND FOR WHICH PATIENTS, VARIETY
THERE, WE HAVEN'T SCRATCHED THE
SURFACE OF THAT.
WHAT METHODS, AGAIN THIS IS
WHERE I'M INTERESTED AS
COMMUNITY HEALTH CENTER WHAT
METHODS EFFECTIVE FOR DOING THIS
IN COMMUNITY HEALTH CENTER
SETTINGS, ARE THERE POTENTIAL
HARMS FOR THE SCREENING?
REMEMBER THE CHECKLIST IF YOU'RE
A PATIENT AND YOU DW AND YOU
FEEL LIKE YOUR PROVIDER IS
HOUSING INSECURE, NOT ENOUGH TO
EAT, THAT COULD ALSO IMPACTED
NEGATIVELY YOUR TRUST, THAT
DOESN'T FEEL GOOD.
AGAIN, HOW MUCH IMPACT CAN WE
EVEN THINK WE'RE GOING TO MAKE
WITH SCREENING AND REFERRALS
SPECIFICALLY GIVEN HOW
INADEQUATELY THIS COUNTRY FUNDS
SOCIAL SERVICES?
I MEAN, AND WE COULD TALK ABOUT
THAT YOU ADAY IF YOU WANT.
AND I WOULD PUT TO THIS
GRURNTION HOW -- GROUP HOW ARE
THESE IMPACTS DIFFERENT OR
SPECIFIC TO PVD.
I BELIEVE THAT IS THE LAST
SLIDE.
NEXT.
LET'S CHECK.
MAKE SURE I DIDN'T LEAVE
SOMETHING OUT.
YES.
GREAT.
ALL RIGHT.
>> THANK YOU SO MUCH, DR. GOLD.
THAT WAS EXCELLENT.
VERY PRACTICAL TALK FOR US.
I'M SURE PEOPLE TOOK A LOT FROM
THAT.
ONE QUESTION I HAD FOR YOU SINCE
YOU'RE THE LAST ONE, YOU'LL BE
THE FIRST ONE UP FOR THE
QUESTION SESSION.
SO WHEN IT COMES TO, WHEN DID
YOU CALM IT, NOT SOCIAL
DETERMINANTS BUT --
>> I PREFER SOCIAL RISKS.
>> SOCIAL RISKS.
VERY GOOD.
>> I CAN TELL YOU WHY, BUT WE
DON'T NEED TO GO INTO IT.
YEAH.
>> SO WE'VE HAD MULTIPLE
DISCUSSANTS ASK ME, WHAT -- AND
I WOULD LIKE TO GET YOUR OPINIOF
MEASUREMENT TOOL, SORT OF
STANDARDIZED MEASUREMENT TOOL
WOULD YOU RECOMMEND FOR PEOPLE
WHO ARE TRYING TO IMPLEMENT THIS
INTO THEIR CLINIC?
>> GREAT QUESTION AND I HEAR IT
ALL THE TIME.
SO FIRST OF ALL, I WOULD JUST
SAY THAT IN ONE OF THE GUIDES ON
THE IMPLEMENTATION GUIDE I GAVE
YOU, WE TALK ABOUT THAT QUITE A
BIT.
THIS IS AN INTERESTING QUESTION.
OVERALL, I WOULD SAY USE
WHATEVER TOOL IS MORE
COMFORTABLE FOR YOU, LIKE IF
YOUR STAFF LIKES ONE TOOL,
THERE'S A WHOLE BUNCH OF
DIFFERENT TOOLS OUT THERE, IF
YOU REQUEST TO THE SIREN WEBSITE
THEY'VE GOT A WHOLE PAGE THAT
COMPARES DIFFERENT SOCIAL RISK
SCREENERS THAT ARE OUT THERE,
NONE OF THEM HAVE -- THE FOLKS
WHO CREATED THE PREPARE TOOL,
PREPARE, THEY CLAIM THAT IT HAS
BEEN VALIDATED.
I WOULD SAY THEIR DEFINITION OF
VALIDATED IS NOT MY DEFINITION
OF VALIDATED, AND IT'S A LONG
TOOL, AND I'VE HEARD MANY USERS
SAY I DON'T WANT TO USE THAT
TOOL, IT'S TOO LONG.
NOW, YOU MIGHT JUST HAVE TO USE
THE SCREENING TOOL THAT YOU'RE
REQUIRED TO USE IF IT'S TIED TO
REIMBURSEMENT LIKE THE
ACCOUNTABILITY HEALTH
COMMUNITY'S TOOL THERE'S A FOUR
QUESTION EXPRERGS A LOT OF FOLKS
NOW IF YOU'RE TRYING TO DO THIS
AS PART OF A PROJECT WITH CMS
YOU'LL PROBABLY HAVE TO USE
THEIR TOOL AND I THINK THAT'S
FINE AS WELL.
BUT MY OVERARCHING ADVICE ON
THIS IS JUST LOOK AT THE
DIFFERENT TOOLS THAT ARE OUT
THERE AND USE WHICHEVER ONE
FEELS LIKE IT'S GOING TO WORK
BETTER FOR YOUR PATIENTS.
MAYBE YOU WANT TO RUN DIFFERENT
TOOLS BY YOUR PATIENTS AND SEE
WHAT THEY FEEL MORE COMFORTABLE
WITH.
THERE IS NO ONE TOOL THAT IS
HIGHLY BETTER THAN THE OTHERS,
THERE IS NO EVIDENCE THAT ANY OF
THE TOOLS ARE BETTER THAN THE
OTHERS.
I DON'T THINK -- HOW DO YOU EVEN
LIKE VALIDATE SOMEONE BEING
HOMELESS OR HOUSING INSECURE?
I DON'T KNOW IF THAT EVEN CAN BE
DONE.
>> GOOD POINT.
>> MY ANSWER TO THAT IS IT
DOESN'T REALLY MATTER BUT I
HIGHLY RECOMMEND GOING TO THE
SIREN WEBSITE AND LOOKING AT
THEIR COMPARISON OF THE
DIFFERENT TOOLS BECAUSE THAT'S A
USEFUL RESOURCE.
>> JUST A GREAT TALK.
YOU KNOW, I HAVE A COUPLE
QUESTIONS.
YOU BROUGHT UP THE WHOLE POINT
ABOUT THE ASSISTANCE
INTERVENTIONS AND LOOKING AT THE
POINT THAT THE PATIENT CAN BE
REFERRED BUT THERE MAY NOT BE
ADEQUATE RESOURCES.
HAS ANYBODY LOOKED IN THE
PARTICULAR COMMUNITY AT THE
RATIO OF, SAY, REFERRALS TO
RESOURCES?
SO TO SAY, YOU KNOW, GEE, WE
KIND OF DID WHAT WE WERE TRYING
TO DO BUT IT WASN'T THERE?
>> THAT IS A GREAT QUESTION.
IF ANYONE HAS -- I'M NOT -- IF
ANYONE HAS, I'M NOT AWARE OF IT,
THAT DOESN'T MEAN IT'S NOT OUT
THERE.
I'M WORKING WITH SOME COLLEAGUES
RIGHT NOW TO SEE IF WE CAN STUDY
THAT.
I'M NOT AWARE OF ANYONE WHO HAS
DONE THAT YET BUT THAT MAY MEAN
THAT I'VE MISSED ARCH ARTICLE OR
SOMETHING.
>> THEN I GUESS THE SECOND
QUESTION, BECAUSE I HEAR ABOUT
THIS TOO, IS, HAS ANYBODY SHOWN
THAT, YOU KNOW, IMPLEMENTING
THESE KINDS OF PROGRAMS, SAY
EVEN SOMETHING AS SIMPLE AS JUST
IMPLEMENTING THE NAVIGATOR, HAS
LED TO A REDUCTION IN HEALTHCARE
COSTS?
AND I ASK THAT BECAUSE THAT IS
WHAT WILL GET PEOPLE'S ATTENTION
TO MAKE CHANGES.
>> YES.
I VERY RECENTLY SAW AN ARTICLE
ON THE ROI OF SOCIAL RISK
INTERVENTION.
I WILL TRY AND FIND THAT FOR YOU
AND PUT IT IN THE CHAT
MOMENTARILY.
IF I CANNOT FIND IT QUICKLY, I
WILL E-MAIL IT.
THERE IS A RECENT ARTICLE ON
THAT.
I DON'T HAVE IT AT MY
FINGERTIPS, BUT I'LL TRY AND
FIND IT FOR YOU.
>> BECAUSE I THINK, YOU KNOW,
EVEN TOO, YOU KNOW, THINKING
ABOUT THIS FOR SOMEONE WHO
LIVES, THINKING IN A PRECISION
MEDICINE WORLD, THIS IS ALMOST
LIKE YOU HAVE TO TAKE A
PERSONALIZED OR INDIVIDUALIZED
APPROACH TO EACH PERSON TO
IDENTIFY, YOU KNOW, THE SOCIAL
RISKS AND THEN TO IMPLEMENT SOME
KIND OF PROGRAM THAT WORKS FOR
THAT PARTICULAR PERSON.
>> YEAH.
THE NEED FOR IT TO BE
PERSONALIZED IS OBVIOUS, RIGHT?
I MEAN, AND YET --
>> ABSOLUTELY.
>> AND YET IT CAN BE SOMEWHAT
SYSTEM MATIZED, RIGHT?
THAT'S THE NICE THING ABOUT JUST
HAVING -- MY RECOMMENDATION
AGAIN WILL BE, CLINICS HAVE TO
DO WHAT WORKS FOR THEM, BUT I
WOULD SAY, AND THIS IS BASED ON
THE RESEARCH THAT I'VE READ IS
LIKE ASK ABOUT FOOD, HOUSING,
TRANSPORTATION AND MEDICATION
AFFORDABILITY.
RIGHT?
BECAUSE GETTING MEDS IN THE BODY
IS FAR HARDER THAN YOU THINK,
RIGHT?
BECAUSE OF ALL THESE OTHER
BARRIERS, HOUSING,
TRANSPORTATION, OH, GOD, I CAN'T
GET MY PRESCRIPTION, BLAH, BLAH,
BLAH.
SO YOU COULD START WITH SOME
SORT OF BASIC BUILDING BLOCKS
THERE AND THEN ONCE YOU HAVE AN
INDIVIDUAL PATIENT WHO IS LIKE
YEAH ACTUALLY THEIR FOOD IS AN
ISSUE, THEN YOU COULD SORT OF
PERSONALIZE IT.
THIS IS WHY THAT PERSONAL
CONVERSATION IS SO IMPORTANT,
RIGHT?
AND IT'S WHY PATIENTS DON'T LIKE
BEING TREATED LIKE CHECK BOX IN
TERMS OF MY SOCIAL NEEDS AND
IT'S WHY CLINIC STAFF AT LEAST
THOSE WHO WORK WITH LOW-INCOME
PATIENT AS A CALLING DON'T FEEL
GREAT ABOUT IT, LIKE WE NEED TO
HAVE THAT CONVERSATION.
WHY HAVING A NAVIGATOR CAN
REALLY BE HELPFUL BECAUSE THEN
THAT PERSON IS GETTING THAT
PERSONALIZED CARE.
I DID FIND THAT ROI ARTICLE, I
CAN PUT IT IN THE THE CHA, IT'S
A VERY RECENT ARTICLE SO THAT
SHOULD ANSWER YOUR QUESTION.
>> THAT'S GREAT.
THANK YOU.
>> RACHEL, DO YOU THINK THAT, IS
IT IMPORTANT, DO YOU THINK, TO
HAVE SOMEONE IN THE COMMUNITY
LIKE A COMMUNITY HEALTH WORKER
INTERACTING WITH THE NAVIGATOR
TO --
>> OR BEING THE NAVIGATOR.
>> BEING THE NAVIGATOR, OKAY.
>> THAT'S A GREAT QUESTION.
WE ARE ACTIVELY CONDUCTING A
TRIAL RIGHT NOW IN, WELL, WE'RE
RECRUITING FOR A TRIAL, THAT
WILL BE IN 26 COMMUNITY HEALTH
CENTERS WHRKS WE HIT RECRUIT --
WHEN WE HIT RECRUITMENT, THAT IS
LOOKING AT WHAT DOES IT TAKE TO
IMPLEMENT SOCIAL RISK SCREENING
AND REFERRAL MAKING THAT IS
DRIVEN BY COMMUNITY HEALTH
WORKERS.
I THEORIZE, I HYPOTHESIZE THAT
COMMUNITY HEALTH WORKERS ARE A
BIG PART OF THE SOLUTION HERE,
THAT WE SHOULD JUST BE LIKE,
YEAH, THIS IS NOT FOR THE
PROVIDER, THIS MAYBE ISN'T EVEN
FOR THE MA, THIS IS A ROLE FOR
THE COMMUNITY HEALTH WORKER OR
THE SOCIAL WORKER AND THEY HAVE
TO FIGURE OUT A WORKFLOW SO THAT
PATIENT IS GETTING CONTACTED AND
SUPPORTED BUT I THINK A
COMMUNITY HEALTH WORKER IS
PROBABLY A REALLY GREAT SOLUTION
TO THIS PROBLEM, THEY'RE NOT
EXPENSIVE, THEY'RE LESS
EXPENSIVE, AND THEY'RE PART OF
THE COMMUNITY AND THEY'RE GOING
TO BE ABLE TO PROVIDE THAT
PERSONALIZED CARE.
I'LL LET YOU KNOW WHAT WE FIND
WITH THE STUDY, BUT I SUSPECT
THE COMMUNITY HEALTH WORKERS ARE
A BIG PART OF THE SOLUTION.
>> GREAT.
>> WHAT WE NEED THOUGH IS THEN
TO PAY FOR THEM.
THEN THEY HAVE TO BE REIMBURSED
AND THAT WILL BE MOST OF THE
TIME THROUGH MEDICAID OR
MEDICARE AND THEN THE STATE
VARIATION WHAT THEY'LL PAY FOR
IS GOING TO BE MORE AND MORE
LIKE STATE, YOU KNOW, STATE
DISPARITIES, AS WE'VE SHOWN MANY
TIMES WITH FOR EXAMPLE MEDICAID
EXPANSION, PATIENTS IN MEDICAID
EXPANSION STATES HAVE MUCH
BETTER OUTCOMES THAN THOSE THAT
DON'T.
MANY ARTICLES ON THIS.
>> DO YOU KNOW, IS THERE A
CREDENTIALING PROCESS FOR
COMMUNITY HEALTH WORKERS?
>> YES, THERE IS.
I DON'T THINK IT'S VERY
COMPLICATED, THOUGH.
I COULD BE WRONG.
DON'T QUOTE ME ON THAT.
BUT I DON'T THINK IT'S VERY
DIFFICULT.
>> OKAY.
JANE, YOU HAD A QUESTION I THINK
FOR DR. BRITAIN.
>> I DID.
I WAS JUST GOING TO BRING THAT
UP, IF HE WAS AROUND.
>> YES.
>> HI.
SO YEAH, I DID WANT TO ASK YOU,
YOU KNOW, I REALLY LOVE THE VA
STUDIES.
CAN YOU TELL ME, DO YOU KNOW
WHAT PERCENTAGE OF U.S. VETSZ
ACTUALLY AK -- VETS ACTUALLY
ACCESS NEWS, THE V -- ACTUALLY
ACCESS AND USE THE VA SYSTEM AND
WOULD BE INCLUDED IN YOUR
DATABASE?
>> THAT'S A GOOD QUESTION.
I THINK YOU'RE GETTING TO THE
NOTION THAT THEY HAVE ACCESS AND
SEEK CARE OUTSIDE OF VA ACCESS.
I DON'T KNOW HARD NUMBERS.
I WILL SAY THAT FOR COMORBIDITY
AND OUTCOME DATA IN THOSE
STUDIES, WE DO INCORPORATE
MEDICARE AND MEDICAID DATA AND
FEE FOR SERVICE DATA, WHICH IS
ONE OF THE REASONS SOME OF THOSE
STUDIES LOOK A LITTLE OUT OF
DATE BECAUSE THERE'S A DELAY IN
GAINING ACCESS TO MEDICARE AND
FEE FOR SERVICE DATA, SO THE
STUDIES THAT WE PUBLISH
INCORPORATE THAT, BUT I DON'T
KNOW OFF HAND WHAT THOSE
PROPORTIONS ARE.
>> YEAH.
I MEAN, AND I ASK THIS BECAUSE
THE LAST THAT I HAD HEARD AS
WELL WAS THAT IT WAS OFTEN IN
THE LOWER, YOU KNOW, IT WAS
ABOUT 30% WHO SOUGHT ALL ROUTINE
HEALTHCARE AT THE VA HEALTHCARE
SYSTEM AND THAT WHEN PEOPLE
LOOKED AT SOCIOECONOMIC STATUS,
THAT IT WAS THE INDIVIDUALS WHO,
YOU KNOW, TENDED TO SCALE UP THE
LOWER END.
SO I JUST THINK THAT EVEN
REGARDLESS OF WHAT IT IS, THE
FACT THAT YOU'RE FINDING SO
CLOSELY MIRROR WHAT'S SEEN AT
VANDERBILT IS REALLY
FASCINATING.
>> YEAH, THAT WAS ONE OF THE
TAKE-HOMES AND IT'S BEEN A
SURPRISE FOR ME IS HOW SIMILAR
THE COMORBIDITY PROFILES ARE,
WITH A COUPLE OF EXCEPTIONS THAT
I NOTED, AND THE PH PROFILES.
>> YEAH.
THE OTHER THING THOUGH THAT WAS
INTERESTING WAS THE STUDY YOU
WERE SHOWING AS WELL LOOKING AT
HEART FAILURE AND COPD WITH
HEART FAILURE INCREASING RISK.
IS THAT ALL CAUSED -- ALL HEART
FAILURE, OR IS THAT MOSTLY
HEF PEF?
>> IT'S EHR PHENOTYPING SO TAKE
THAT WHAT IT'S WORTH.
THAT WAS LUMPING.
WE DO HAVE SUBGROUP ANALYSIS
THAT SPLITS THAT OUT IN THAT
PAPER, AND HEF REF HAD HIGHER
INCIDENCE RATES THAN HEF PEF,
NOT DRAMATICALLY DIFFERENT.
>> INTERESTING.
YEAH.
SO THAT'S REALLY GOOD.
I THINK GABBY HAS A QUESTION.
>> YES, PLEASE.
I WAS REALLY FASCINATED BY THE
VETERANS TALK AS WELL, AND WHAT
STRUCK ME IS THIS ONE SLIDE THAT
YOU SHOWED THAT ALTHOUGH
PULMONARY HYPERTENSION WAS
STRONGLY SUGGESTED BY ECHO, IT
WASN'T CODED.
DOES THAT MEAN THAT IF IT'S NOT
CODED, THEN PATIENTS DON'T GET
MANAGEMENT FOR PULMONARY
HYPERTENSION?
I ASSUME.
>> THAT'S A GREAT QUESTION.
I MEAN, FROM PERSONAL
EXPERIENCE, I KNOW I MISCODE
PROBABLY ALL THE TIME.
WE SORT OF DO THAT A LITTLE BIT
OUT OF CONVENIENCE AND WHAT'S
SORT OF THE PROXIMAL DIAGNOSIS
THAT WE'RE SEEING THE PROBLEM
THAT DAY.
SO SOME OF THAT IS, YOU KNOW,
JUST SORT OF USUAL CLINICAL
CARE.
I DON'T KNOW FOR SURE WHETHER
THE ABSENCE OF A CODE EQUALS THE
ABSENCE OF TREATMENT OF
CARDIOVASCULAR DISEASE, BUT ALSO
KEEP IN MIND THAT AMONG THE
VETERANS, YOU KNOW, GROUP ONE
PH'S IS LESS COMMON IN GENERAL.
>> YEAH.
THANK YOU.
>> I'LL ASK SOMEWHAT OF IKS A
CONTROVERSIAL QUESTION, EVAN.
THIS IS FOR YOU, BUT ANYBODY CAN
ANSWER, I SUPPOSE, AS WELL.
SO YOU BROUGHT UP THE POINT,
OBVIOUSLY EVEN OUTSIDE OF PH,
THE DIFFICULTY IN RESEARCHING
HOMELESSNESS.
I'M ASSUMING THAT THAT WAS AN
ISSUE OUTSIDE OF PH ALSO.
YOU KNOW, RECENTLY, THE SUPREME
COURT HAS SOMEWHAT CRIMINALIZED
HOMELESSNESS.
DO YOU FEEL LIKE THAT THESE
ISSUES THAT WE ARE MOVING
TOWARDS AS A SOCIETY MIGHT BE AN
IMPEDIMENT TO STUDYING EVEN MORE
THE HOMELESS POPULATION?
>> SO GREAT QUESTION.
I'LL START WITH A DISCLAIMER
THAT I'M AN EXPERT AT ALL ON THE
SOCIAL ISSUES AROUND
HOMELESSNESS OR THE INHERENT
POLITICAL ISSUES THERE EITHER.
YOU KNOW, BUT I DO THINK THAT
THERE ARE OBVIOUSLY INHERENT
CHALLENGES WITH UNDERSTANDING
ANY CHRONIC DISEASE IN THAT
POPULATION, SO FOCUSING ON PH
SPECIFICALLY IS A LITTLE BIT
SORT OF HARD TO JUSTIFY WHEN
THERE IS PROBABLY LOWER HANGING
FRUIT TO UNDERSTAND AROUND
CARDIOPULMONARY AND
CARDIOVASCULAR DISEASE.
BUT OTHERWISE, I FEEL SORT OF
UNQUALIFIED TO HAVE A STRONG
OPINION ON SORT OF THE POLITICAL
ASPECTS.
OTHERS MAY NOT.
>> WELL, I CAN TELL YOU IT'S
BEEN AN ISSUE HERE TRYING TO
STUDY METHAMPHETAMINE USE, I
MEAN, IT BEING CRIMINALIZED, OF
COURSE.
SO IT'S BEEN AN ISSUE FOR US.
ANY OTHER QUESTIONS FOR THE
GROUP FROM THE DISCUSSANTS?
I DON'T SEE ANYTHING IN THE
CHAT.
I HAVE A QUICK QUESTION FOR
DR. BERNARDO.
IS HE STILL THERE?
SORRY.
IS THERE BERNARDO STILL THERE?
>> I DON'T SEE HIM IN THE
ATTENDEE LIST.
>> YOU DO NOT OR -- SORRY,
JACKIE?
>> I DO.
>> I'M STILL ON.
>> OH, OKAY.
SO ROBERTO YOU SHOWED A MAP OF
SEGREGATION IN THE U.S.,
ALTHOUGH YOU ALLUDED TO THAT
BEING A FAIRLY OLD MAP.
I'M GOING TO ADVOCATE SLIGHTLY
FOR THE NATIVE AMERICAN
POPULATION HERE BECAUSE WE
HAVEN'T DISCUSSED MUCH IN THAT
REGARD, BUT IN ARIZONA, I'M SURE
YOU KNOW, YOU TRAINED HERE, MANY
PEOPLE DO KNOW THAT THE NATIVE
AMERICAN POPULATION IS A
SIGNIFICANT PRESENCE.
IN FACT, I HAVE A CLINIC AT THE
APACHE RESERVATION.
WE SEE PATIENTS FROM THE NAVAJO,
THE APACHE RESERVATIONS.
IT STRIKES ME THAT ALTHOUGH
ARIZONA IS A NONSEGREGATED AREA
THAT IF YOU LOOK AT THE
DISPARITY THAT IS WE SEE BETWEEE
SEE OF THE NATIVE AMERICANS WHO
LIVE ON THE RESERVATION VERSUS
THOSE WHO DO NOT THERE STILL
SEEMS TO BE SUBSTANTIAL
SEGREGATION IN THAT REGARD.
CAN YOU COMMENT IN REGARD TO
WHAT YOU THINK IS A BUT WAY FOR
US TO CAPTURE NATIVE AMERICAN
INTERESTS, ESPECIALLY THOSE WHO
LIVE OR DO NOT LIVE ON THE
RESERVATION WITH REGARD TO
SEGREGATION?
>> THAT'S A COMPLICATED
QUESTION, FRANZ.
I WISH NINA WERE STILL IN THE
AUDIENCE BECAUSE SHE COULD ALSO
CONTRIBUTE TO THIS DISCUSSION,
BUT NATIVE AMERICANS IS A
HISTORICALLY NEGLECTED
POPULATION IN MUCH NEED OF MORE
DETAILED RESEARCH WHEN IT COMES
TO RARE DISEASES, SUCH AS PH.
LTS VERY CHALLENGING TO GET --
IT IS VERY CHALLENGING TO GET
PERMISSION TO DO RESEARCH WITH
THIS SPECIFIC GRURP BEING AS YOU
PROBABLY KNOW.
-- WITH THIS SPECIFIC GROUP, AS
YOU PROBABLY KNOW.
THERE ARE MANY APPROVAL FORMS
THAT YOU NEED TO GET TO BE
AUTHORIZED TO BE ABLE TO WORK
WITH THE NATIVE AMERICAN
POPULATIONS, AND WHICH ONE OF US
HAS BEEN ABLE TO TAKE CARE OF
SOME OF THESE PATIENTS, I DID
WHEN I WAS LIVING IN OKLAHOMA,
IT'S JUST VERY CHALLENGING BUT
THE HEALTHCARE SYSTEM THEY HAVE,
I CAN'T REMEMBER THE NAME, BUT
THE HEALTHCARE SYSTEM THEY HAVE
IS VERY RESTRICTIVE.
YOU NEED TO GET APPROVAL FOR --
>> IHS.
>> IHS, THAT IS CORRECT, FOR
EVERY SINGLE TESTING OR
PRESCRIPTION YOU WANT TO DO, IS
WE THINK A RARE DISEASE,
CERTAINLY HAS A DETRIMENTAL
EFFECT ON MINORITIES, NATIVE
AMERICANS ARE BY FAR I THINK THE
MOST DISADVANTAGED GROUP.
AND I DON'T HAVE A CLEAR ANSWER
TO YOU ABOUT HOW TO SUCCESSFULLY
PROCEED WITH RESEARCHING THIS
POPULATION, BUT I THINK WE
SHOULD CERTAINLY CONSIDER DOING
THAT.
AND I WOULD SAY I BELIEVE
PD-OMICS -- PROTEOMICS, EVEN
THOSE 14 PAGES WOULD BE
SOMETHING THAT WOULD BE WORTH
PURSUING FURTHER INVESTIGATION
BECAUSE IN REALITY WE HAVE
NOTHING, NOTHING TO COMMENT
ABOUT WHAT'S THE REALITY OF
NATIVE AMERICAN PATIENTS WITH
PH.
>> OKAY.
ANY OTHER QUESTIONS, COMMENTS IS
IT THANK YOU, DR. BERNARDO FOR
THAT.
>> MY ONLY COMMENT IS, I'M YOUR
NEIGHBOR TO THE NORTH, RIGHT?
AND, YOU KNOW, IT'S A UNIQUE
HISTORY WITH NATIVE AMERICANS,
AND I MENTOR A PHYSICIAN, A
PULMONARY PHYSICIAN OF NATIVE
AMERICAN DESCENT WHO MOVED HERE
FROM ROCHESTER, MAYO CLINIC, AND
I LEARNED A LOT BY WORKING
ALONGSIDE OF HER, THINGS I
DIDN'T KNOW AS SOMEBODY WHO
WORKED A LOT WITH HEALTH
DISPARITY RESEARCH, THE NATURE
OF THE SOVEREIGN STATE, THE
COMMUNITY AND HOW, YOU KNOW, YOU
REALLY DO -- AND I WOULD SAY
WITH ANY MINORITY COMMUNITY, BUT
THEY GIVE US A GOOD REMINDER
THAT IF YOU WANT TO COME AND DO
RESEARCH IN A COMMUNITY THAT'S
UNDERREPRESENTED CIALG THE BEST
IDEA IS -- THE BEST IDEA STONT
SAY I WANT TO DO RESEARCH ON
THIS POPULATION, THE BEST
APPROACH IS TO COME IN AND
UNDERSTAND WHAT THEIR THOUGHTS
AND WHAT THEIR LEADER AND
COMMUNITY IS THINKING AND THEN
AFTER THAT, YOU KNOW, TRY TO
PARTNER WITH THEM AND THEN BRING
ON RESEARCH LATER.
IT'S NOT, YOU KNOW -- AND I
THINK THERE'S A I'VE LANDER A
LOT OF LESSONS FROM THOSE
APPROACHES AND WE DO EMPLOY SOME
OF THOSE APPROACHES WITH OUR
COHORT AND I THINK YOU'RE
FAMILIAR WITH THAT -- 4,000
MEXICAN AMERICANS FROM MOUNTAIN
PARK HEALTH CENTER, LARRY
MANDARINO OVER THERE WAS THE
STAT STARTER OF THAT, I'M NOW
SUPPORTING THAT, AND WE CONTINUE
THAT KIND OF APPROACH WITH DMUNT
AS WELL, WHERE WE DON'T COME IN
AND SAY WE WANT TO DO RESEARCH.
WE COME IN AND POSE QUESTIONS
ABOUT THINGS THAT MIGHT BE
RELEVANT TO THE COMMUNITY AND
THEN WE ENGAGE THEM AND SPEAK
WITH THEM AND THEN BRING UP
RESEARCH AT A LATER TIME.
YOU KNOW, I THINK THAT THOSE ARE
THE KIND OF THINGS THAT HELP
BREAK BARRIERS OF DISTRUST
ESPECIALLY IN POPULATIONS THAT
WERE TARGETED FOR ANNIHILATION
GENERATIONS AGO.
WE REALLY HAVE TO DO THE HARD
WORK TO ENGAGE THOSE COMMUNITIES
IN A DIFFERENT WAY BECAUSE WE
JUST -- IT'S THE RIGHT THING TO
DO.
AND THIS POPULATION IS NO
EXCEPTION.
IN PULMONARY HYPERTENSION.
>> LET ME JUST ADD ON TO THAT,
ONE PARTICULARLY VULNERABLE
POPULATION, ROBERTO, I DON'T
KNOW IF YOU'VE ENCOUNTERED THE
CHOCTAW POPULATION BUT THEIR
RATES OF SCLERODERMA OR FIVE TO
TEN TIMES HIGHER THAN THE
GENERAL POPULATION AND THINKING
ABOUT PULMONARY VASK ALREADY
DISEASE, BASED IN OKLAHOMA,
PARTICULARLY SOUTHEAST, I DON'T
KNOW IF YOU HAD ANY EXPERIENCE
IN YOUR TIME IN OKLAHOMA,
ROBERTO, BUT THAT MIGHT BE A
PARTICULARLY VULNERABLE
POPULATION FOR VASCULAR DISEASE
THAT WE COULD CONSIDER AS A
PRIORITY IN OUR PRIORITY
STATEMENTS.
>> THAT'S A GREAT IDEA, STEVE.
YES.
THE FREQUENCY OF CONNECTIVE
TISSUE DISEASE WAS CERTAINLY
HIGHER THAN OTHER POPULATIONS,
AT LEAST IN OKLAHOMA THE
FREQUENCY OF METHAMPHETAMINE USE
WAS ALSO HIGHER THAN WHAT I
WOULD HAVE EXPECTED.
SO I BELIEVE NATIVE AMERICANS
HAVE MULTIPLE -- CERTAINLY
CONNECTIVE TISSUE DISEASE WAS A
FREQUENT PHENOTYPE WE
ENCOUNTERED AND I THINK WE
SHOULD PARTNER TO STUDY THIS
POPULATION IN MUCH MORE DETAIL.
>> ALL RIGHT.
WELL, WITH THAT, I'M GOING TO
MOVE ON TO JUST A SHORT OVERVIEW
OF TOMORROW.
WE'RE A LITTLE OVER TIME.
IT'S BEEN A GREAT DAY.
I HAVE TO SAY, WITH SOME
EXCELLENT SPEAKERS, EXCELLENT
TALKS AND EXCELLENT DISCUSSION.
TOMORROW WE WILL CONTINUE WITH
HEALTH DISPARITIES IN PULMONARY
VASCULAR DISEASE LOOKING
SPECIFICALLY AT HEAT EXPOSURE
WITH DR. MARON, DR. LIM AND
THERE MATHAI WILL GIVE US SOME
MORE INSIGHTS INTO
IMPLEMENTATION SCIENCE.
AND THEN WE'LL MOVE ON TO THE
OMICS PRESENTATIONS AND GENOMICS
WHICH I'M REALLY EXCITED TO SEE,
WITH DR. ORTEGA AND DR. GLEN AND
DR. DESAI AND LASTLY WE'LL
FINISH THINGS UP WITH THE
PVD OMICS SESSION BEFORE WE MOVE
TO IT A DISCUSSION SESSION.
DR. LEOPOLD, DO YOU HAVE ANY
OTHER COMMENTS FOR THE DAY?
>> I JUST WANT TO SAY IT REALLY
HAS BEEN A FANTASTIC DAY OF
TALKS, AND I'M REALLY LOOKING
FORWARD TO CONTINUING THE
DISCUSSION TOMORROW.
AND MANY THANKS TO TODAY'S
SPEAKERS.
>> DR. X I AO?
>> NOTHING TO ADD.
JUST TO ECHO WHAT JANE SAID,
THIS IS A REALLY WONDERFUL
MEETING AND I LEARNED A LOT FROM
ALL THE SPEAKERS.
THANK YOU TO EVERYONE'S EFFORT.
I'M LOOKING FORWARD FOR
TOMORROW'S MEETING.
>> ALL RIGHT.
GREAT.
WE WILL SEE EVERYONE AT
10:00 A.M. EASTERN TIME
TOMORROW.
THANKS AGAIN.
HAVE A GOOD DAY.
>> ALL RIGHT.
THANKS.
>> BYE-BYE.
[THE MEETING CONCLUDED AT
5:38 P.M. EST]