BiDil as a Case Study

8/8/2019 BiDil as a Case Study

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The Cardiovascular Drug BiDilThe Cardiovascular Drug BiDil

as a Case Study of the Ethics ofas a Case Study of the Ethics of

RaceRace--Based MedicineBased Medicine

Naomi ChenNaomi Chen

Biology Capstone PresentationBiology Capstone PresentationDecember 10, 2005December 10, 2005


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Presentation GoalsPresentation Goals

To introduce the bioethical controversyTo introduce the bioethical controversy

surrounding BiDils use as a raciallysurrounding BiDils use as a racially--

targeted drugtargeted drugTo discuss the North American churchsTo discuss the North American churchs

response to the implementation of raceresponse to the implementation of race--

based medicinebased medicine


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What is BiDil?What is BiDil?

Cardiovascular raceCardiovascular race--based drugbased drug

combinationcombination

Isosorbide dinitrate and hydralazineIsosorbide dinitrate and hydralazinehydrochloridehydrochloride

Nitric oxide donor which aids in vasodilationNitric oxide donor which aids in vasodilation

(Taylor et al. 2004)(Taylor et al. 2004)

FDA approval June 2005FDA approval June 2005 Marketed exclusively to AfricanMarketed exclusively to African--AmericansAmericans

(Verderese 2005)(Verderese 2005)


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Background on BiDilBackground on BiDil

VV--HeFT I (1980s): Effective, regardless ofHeFT I (1980s): Effective, regardless of

racerace

VV--HeFT II (1990s): Overshadowed byHeFT II (1990s): Overshadowed byACE inhibitorsACE inhibitors

AA--HeFT (2002):HeFT (2002):

Reduced mortality in blacks by 43% (TaylorReduced mortality in blacks by 43% (Taylor2004)2004)

Study was ended early (Thompson 2005)Study was ended early (Thompson 2005)


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A Controversial StudyA Controversial Study

Lack of an equivalent white cohortLack of an equivalent white cohort

Trial studied BiDil versus placebo, but notTrial studied BiDil versus placebo, but not

versus ACE inhibitors (Taylor et al. 2004,versus ACE inhibitors (Taylor et al. 2004,Thompson 2005)Thompson 2005)


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A Controversial Study (cont)A Controversial Study (cont)

Original patent expiration imminent (2007)Original patent expiration imminent (2007)

FDA hint in 2001FDA hint in 2001

Financial incentive to present BiDil as aFinancial incentive to present BiDil as aracerace--specific drugspecific drug

FDA approval granted; new patent validFDA approval granted; new patent valid

through 2020 (Verderese 2005, Kahnthrough 2020 (Verderese 2005, Kahn2005)2005)


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Why is BiDil Controversial?Why is BiDil Controversial?

Perceived by some as a step forwardPerceived by some as a step forward

towards better medicinetowards better medicine

Perceived by others as a regressionPerceived by others as a regressiontowards eugenics and racism in healthcaretowards eugenics and racism in healthcare


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BiDil as an AdvanceBiDil as an Advance

Beneficial in the area of targeted medicineBeneficial in the area of targeted medicine

An ideal drug for black patients who haveAn ideal drug for black patients who have

poorer outcomes in cases of heart failurepoorer outcomes in cases of heart failure(AHA 2004, NitroMed 2005)(AHA 2004, NitroMed 2005)


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BiDil as Slippery SlopeBiDil as Slippery Slope

Race is too vague a term to use as aRace is too vague a term to use as a

proxyproxy

Akin to eugenics, or the correlation ofAkin to eugenics, or the correlation ofphysical characteristics such as skin colorphysical characteristics such as skin color

with physiological and behavioralwith physiological and behavioral

difference (Duster 1990)difference (Duster 1990)

Based on assumption of biologicalBased on assumption of biological

differences between racesdifferences between races


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Is There a Biological Basis ofIs There a Biological Basis of

Race?Race?NoNo

Human Genome Project findingsHuman Genome Project findings

More variation within races than betweenMore variation within races than betweenthemthem


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Is There a Correlation Between RaceIs There a Correlation Between Race

and Disease?and Disease?

What about TayWhat about Tay--Sachs and otherSachs and other

populationpopulation--specific genetic diseases?specific genetic diseases?

What about differential cancer morbidityWhat about differential cancer morbidityand mortality statistics?and mortality statistics?

What about chronic diseases such asWhat about chronic diseases such as

cancer and cardiovascular disease?cancer and cardiovascular disease?


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Is There a Biological Basis of Race?Is There a Biological Basis of Race?

(cont)(cont)

Ambiguity of the term raceAmbiguity of the term race

Genotype does not equal phenotype;Genotype does not equal phenotype;

current studies may not account forcurrent studies may not account forenvironmental factors, and may downplayenvironmental factors, and may downplay

the importance of environment in diseasethe importance of environment in disease


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Is There a Biological Basis of Race?Is There a Biological Basis of Race?

(cont)(cont)

Even if there isnt a biological basis ofEven if there isnt a biological basis of

race, this racial concept has socialrace, this racial concept has social

ramificationsramifications

Redlining (Economics)Redlining (Economics)

EducationEducation

EmploymentEmployment

Healthcare DisparityHealthcare Disparity


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Are There Genetic CorrelationsAre There Genetic Correlations

Between Populations and HealthBetween Populations and Health

Conditions?Conditions?MaybeMaybe

MultiMulti--gene interactions with environmentgene interactions with environment

So environment is more important than weveSo environment is more important than wevegiven it credit for?given it credit for?

Cases of heart disease, cancer rate statisticsCases of heart disease, cancer rate statistics

often quotedoften quoted

A lot of environment/access issuesA lot of environment/access issuespeople dontpeople dontautomatically assume its genetics aloneautomatically assume its genetics alone


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Implications of Stating that there isImplications of Stating that there is

a Link Between Race and Diseasea Link Between Race and DiseaseSo there is a disease/healthcare/accessSo there is a disease/healthcare/access

disparity along racial lines?disparity along racial lines?

Can this disease disparity be due at all toCan this disease disparity be due at all togenes?genes?


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Does Physiology Differ by Race?Does Physiology Differ by Race?

Forearm vasodilator trialsForearm vasodilator trials

Lesser function of left ventricle trialsLesser function of left ventricle trials

Lesser effectiveness of ACE inhibitorsLesser effectiveness of ACE inhibitorsEqual effectiveness of betaEqual effectiveness of beta--blockersblockers


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What is the Debate?What is the Debate?

Will BiDil exacerbate healthcare disparityWill BiDil exacerbate healthcare disparity

along racial lines?along racial lines?

YesYesInsurance inequalityInsurance inequality

Genetic profilingGenetic profiling

Genetic tests in a clinical setting impracticalGenetic tests in a clinical setting impractical

Not NecessarilyNot NecessarilyIf genes are tied to causation aloneIf genes are tied to causation alone


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History of Racial Disparity inHistory of Racial Disparity in

MedicineMedicineEugenics in the United StatesEugenics in the United States

Nazis Final SolutionNazis Final Solution

Tuskegee Syphilis StudyTuskegee Syphilis Study

Race used to gain powerRace used to gain power


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How Has the Scientific CommunityHow Has the Scientific Community

Responded?Responded?With CautionWith Caution


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How Should the Church Respond?How Should the Church Respond?

Parable of the Good SamaritanParable of the Good SamaritanThe Parable of the Good SamaritanThe Parable of the Good Samaritan2525On one occasion an expert in the law stood up to test Jesus.On one occasion an expert in the law stood up to test Jesus.

"Teacher," he asked, "what must I do to inherit eternal life?""Teacher," he asked, "what must I do to inherit eternal life?" 2626"What"What

is written in the Law?" he replied. "How do you read it?"is written in the Law?" he replied. "How do you read it?"2727He answered: " 'Love the Lord your God with all your heart and withHe answered: " 'Love the Lord your God with all your heart and with

all your soul and with all your strength and with all your mind'all your soul and with all your strength and with all your mind'[[cc]]; and,; and,'Love your neighbor as yourself.''Love your neighbor as yourself.'[[dd]]""

2828"You have answered correctly," Jesus replied. "Do this and you will"You have answered correctly," Jesus replied. "Do this and you willlive."live."

2929But he wanted to justify himself, so he asked Jesus, "And who is myBut he wanted to justify himself, so he asked Jesus, "And who is myneighbor?"neighbor?"


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(cont)(cont)3030In reply Jesus said: "A man was going down from Jerusalem to Jericho, whenIn reply Jesus said: "A man was going down from Jerusalem to Jericho, whenhe fell into the hands of robbers. They stripped him of his clothes, beat himhe fell into the hands of robbers. They stripped him of his clothes, beat himand went away, leaving him half dead.and went away, leaving him half dead. 3131A priest happened to be goingA priest happened to be goingdown the same road, and when he saw the man, he passed by on the otherdown the same road, and when he saw the man, he passed by on the otherside.side. 3232So too, a Levite, when he came to the place and saw him, passed bySo too, a Levite, when he came to the place and saw him, passed byon the other side.on the other side. 3333But a Samaritan, as he traveled, came where the manBut a Samaritan, as he traveled, came where the manwas; and when he saw him, he took pity on him.was; and when he saw him, he took pity on him. 3434He went to him andHe went to him andbandaged his wounds, pouring on oil and wine. Then he put the man on hisbandaged his wounds, pouring on oil and wine. Then he put the man on hisown donkey, took him to an inn and took care of him.own donkey, took him to an inn and took care of him. 3535The next day heThe next day hetook out two silver coinstook out two silver coins[[ee]] and gave them to the innkeeper. 'Look after him,'and gave them to the innkeeper. 'Look after him,'he said, 'and when I return, I will reimburse you for any extra expense youhe said, 'and when I return, I will reimburse you for any extra expense youmay have.'may have.'

3636"Which of these three do you think was a neighbor to the man who fell into"Which of these three do you think was a neighbor to the man who fell intothe hands of robbers?"the hands of robbers?"

3737The expert in the law replied, "The one who had mercy on him."The expert in the law replied, "The one who had mercy on him."Jesus told him, "Go and do likewise."Jesus told him, "Go and do likewise."


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(cont)(cont)Acts 6Acts 6

The Choosing of the SevenThe Choosing of the Seven11In those days when the number of disciples was increasing, the Grecian JewsIn those days when the number of disciples was increasing, the Grecian Jews

among them complained against the Hebraic Jews because their widowsamong them complained against the Hebraic Jews because their widowswere being overlooked in the daily distribution of food.were being overlooked in the daily distribution of food. 22So the TwelveSo the Twelve

gathered all the disciples together and said, "It would not be right for us togathered all the disciples together and said, "It would not be right for us toneglect the ministry of the word of God in order to wait on tables.neglect the ministry of the word of God in order to wait on tables. 33Brothers,Brothers,choose seven men from among you who are known to be full of the Spiritchoose seven men from among you who are known to be full of the Spiritand wisdom.We will turn this responsibility over to themand wisdom.We will turn this responsibility over to them 44and will give ourand will give ourattention to prayer and the ministry of the word."attention to prayer and the ministry of the word." 55This proposal pleased theThis proposal pleased thewhole group. They chose Stephen, a man full of faith and of the Holy Spirit;whole group. They chose Stephen, a man full of faith and of the Holy Spirit;also Philip, Procorus, Nicanor, Timon, Parmenas, and Nicolas from Antioch,also Philip, Procorus, Nicanor, Timon, Parmenas, and Nicolas from Antioch,

a convert to Judaism.a convert to Judaism. 66They presented these men to the apostles, whoThey presented these men to the apostles, whoprayed and laid their hands on them.prayed and laid their hands on them.

77So the word of God spread. The number of disciples in Jerusalem increasedSo the word of God spread. The number of disciples in Jerusalem increasedrapidly, and a large number of priests became obedient to the faith.rapidly, and a large number of priests became obedient to the faith.


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The Church and SystemicThe Church and Systemic

RacismRacismHealth disparity is an example of systemicHealth disparity is an example of systemicracismracism

The church needs toThe church needs to initiate reconciliationinitiate reconciliation

challenge the status quochallenge the status quo

IndividuallyIndividually

CollectivelyCollectively


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How ShouldWe PersonallyHow ShouldWe Personally

Respond to RaceRespond to Race--Based Medicine?Based Medicine?

This research and its implementation canThis research and its implementation can

be used for good or evilbe used for good or evil

Tread lightly, given our nations history andTread lightly, given our nations history and

current struggle with systemic racismcurrent struggle with systemic racism

Thoroughly know the science and theThoroughly know the science and the

assumptions that lie behind its assertions inassumptions that lie behind its assertions in

order to evaluate the value of raceorder to evaluate the value of race--basedbasedmedicinemedicine


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How ShouldWe PersonallyHow ShouldWe Personally

Respond to RaceRespond to Race--Based Medicine?Based Medicine?

(cont)(cont)

Already we see some ways raceAlready we see some ways race--basedbased

medicine has been used for detrimentalmedicine has been used for detrimentalendsends

We must not only expose the evil, but alsoWe must not only expose the evil, but also

use the technology for gooduse the technology for good


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Works CitedWorks Cited

1. Bass SJ, King ML. Blessed are the peacemakers : Martin Luther King, Jr., eight white religious leaders, and the1. Bass SJ, King ML. Blessed are the peacemakers : Martin Luther King, Jr., eight white religious leaders, and the"Letter from Birmingham Jail". Baton Rouge: Louisiana State University Press, 2001."Letter from Birmingham Jail". Baton Rouge: Louisiana State University Press, 2001.2. BowenWG, Bok DC. The shape of the river : long2. BowenWG, Bok DC. The shape of the river : long--term consequences of considering race in college andterm consequences of considering race in college anduniversity admissions. Princeton, N.J.: Princeton University Press, 1998.university admissions. Princeton, N.J.: Princeton University Press, 1998.3. Brawley OW, Freeman HP. Race and outcomes: is this the end of the beginning for minority health research? J3. Brawley OW, Freeman HP. Race and outcomes: is this the end of the beginning for minority health research? JNatl Cancer Inst 1999;91(22):1908Natl Cancer Inst 1999;91(22):1908--1909.1909.4. Cavalli4. Cavalli--Sforza LL, Menozzi P and Piazza A. The history and geography of human genes. Princeton, N.J.:Sforza LL, Menozzi P and Piazza A. The history and geography of human genes. Princeton, N.J.:Princeton University Press, 1996.Princeton University Press, 1996.5. Emerson MO, Smith C. Divided by faith : evangelical religion and the problem of race in America. Oxford ; New5. Emerson MO, Smith C. Divided by faith : evangelical religion and the problem of race in America. Oxford ; NewYork: Oxford University Press, 2000.York: Oxford University Press, 2000.6. Graves JL. The race myth : why we pretend race exists in America. New York: Dutton, 2004.6. Graves JL. The race myth : why we pretend race exists in America. New York: Dutton, 2004.7. Graves JL. The Emperor's new clothes : biological theories of race at the millennium. New Brunswick, N.J.:7. Graves JL. The Emperor's new clothes : biological theories of race at the millennium. New Brunswick, N.J.:Rutgers University Press, 2001.Rutgers University Press, 2001.8. Loue S. Gender, ethnicity, and health research. New York: Kluwer Academic/Plenum Publishers, 1999.8. Loue S. Gender, ethnicity, and health research. New York: Kluwer Academic/Plenum Publishers, 1999.9. Rotimi CN. Are medical and nonmedical uses of large9. Rotimi CN. Are medical and nonmedical uses of large--scale genomic markers conflating genetics and 'race'?scale genomic markers conflating genetics and 'race'?Nat Genet 2004;36(11 Suppl):S43Nat Genet 2004;36(11 Suppl):S43--7.7.10. Royal CD, Dunston GM. Changing the paradigm from 'race' to human genome variation. Nat Genet10. Royal CD, Dunston GM. Changing the paradigm from 'race' to human genome variation. Nat Genet2004;36(11 Suppl):S52004;36(11 Suppl):S5--7.7.11. Schneider EC, Zaslavsky AM and Epstein AM. Racial disparities in the quality of care for enrollees in medicare11. Schneider EC, Zaslavsky AM and Epstein AM. Racial disparities in the quality of care for enrollees in medicaremanaged care. JAMA 2002;287(10):1288managed care. JAMA 2002;287(10):1288--1294.1294.12. Tatum BD. "Why are all the Black kids sitting together in the cafeteria?" And other conversations about race.12. Tatum BD. "Why are all the Black kids sitting together in the cafeteria?" And other conversations about race.New York: BasicBooks, 1997.New York: BasicBooks, 1997.13. Taylor, AL, et al. Combination of Isosorbide Dinitrate and Hydralazine in Blacks with Heart Failure.13. Taylor, AL, et al. Combination of Isosorbide Dinitrate and Hydralazine in Blacks with Heart Failure. NewNewEngland Journal of MedicineEngland Journal of Medicine 2004 vol 351 no 202004 vol 351 no 2014. Verderese C. Drug for Black Patients With Heart Failure Nears Approval: Will BiDil Close orWiden the Racial14. Verderese C. Drug for Black Patients With Heart Failure Nears Approval: Will BiDil Close orWiden the RacialDivide? DOC News 2005;2(6):1Divide? DOC News 2005;2(6):1--3.3.

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BiDil as a Case Study