Tailoring Medication to Tailoring Medication to Patient CharacteristicsPatient Characteristics

Farrokh Alemi, Ph.D.Farrokh Alemi, Ph.D.George Mason UniversityGeorge Mason University

PatentPatent

This presentation is based on a This presentation is based on a patent application on patent application on personalized medication held by personalized medication held by George Mason UniversityGeorge Mason University

Scientists and government Scientists and government organizations have free access organizations have free access to this patentto this patent

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What is informatics?What is informatics?

What is informatics?What is informatics?

Anything you want it to beAnything you want it to be

It could be …It could be …Level 1Level 1

1.1. Identify the need for IT applications in medicine and healthcare Identify the need for IT applications in medicine and healthcare 2.2. Demonstrate competence in the use of appropriate technologies, communication and organisational skills Demonstrate competence in the use of appropriate technologies, communication and organisational skills 3.3. Apply organisational techniques to interpret information and use knowledge Apply organisational techniques to interpret information and use knowledge4.4. Deploy skills required in the administration of patients and their records Deploy skills required in the administration of patients and their records5.5. Describe the characteristics of health and social care information systems. Describe the characteristics of health and social care information systems.6.6. List the strengths and weaknesses of e-communication in healthcare. List the strengths and weaknesses of e-communication in healthcare.7.7. Explain statistical reports. Explain statistical reports.

Level 2Level 2

8.8. Discuss and apply advanced theoretical and practical applications of informatics and computer science. Discuss and apply advanced theoretical and practical applications of informatics and computer science.9.9. Demonstrate use and design of software. Demonstrate use and design of software.10.10. Present data and information processing skills, analyse and assess different coding systems in healthcare. Present data and information processing skills, analyse and assess different coding systems in healthcare.11.11. Define and evaluate informatics standards. Define and evaluate informatics standards.12.12. Display an awareness of the fields of Medicine, health and biosciences and NHS organisation. Display an awareness of the fields of Medicine, health and biosciences and NHS organisation. 13.13. Show appropriate and professional customer service skills. Show appropriate and professional customer service skills.14.14. Describe applications of biomedical informatics specialities. Describe applications of biomedical informatics specialities.

Level 3Level 3

15.15. Critically discuss ethical issues and patients privacy. Critically discuss ethical issues and patients privacy. 16.16. Manage, implement and assess Information and Communication Technology. Manage, implement and assess Information and Communication Technology.17.17. Identify and synthesize solutions for technical/security faults Identify and synthesize solutions for technical/security faults18.18. Present information regarding image and signal processing Present information regarding image and signal processing19.19. Plan, implement, monitor, evaluate and complete projects. Plan, implement, monitor, evaluate and complete projects.20.20. Exhibit managerial skills and knowledge, demonstrate financial awareness, apply problem-solving skills and Exhibit managerial skills and knowledge, demonstrate financial awareness, apply problem-solving skills and

describe different project management frameworks.describe different project management frameworks.

It could be …It could be …

Computational biogeneticsComputational biogenetics Text processing & social networksText processing & social networks BioinformaticsBioinformatics Electronic Health RecordElectronic Health Record RoboticsRobotics Expert systems & machine learningExpert systems & machine learning Decision support systemsDecision support systems Online management of patientsOnline management of patients ErgonomicsErgonomics ……

Technology is SeductiveTechnology is Seductive

Promises efficiencyPromises efficiency

Technology is SeductiveTechnology is Seductive

Promises efficiencyPromises efficiency Takes you to new directionsTakes you to new directions

A classical bait and switch

You cannot take a car for a You cannot take a car for a walkwalk Go short distancesGo short distances Drive to new destinationsDrive to new destinations

Roads, evolutionRoads, evolution

Case of Personalized Case of Personalized MedicineMedicine

What is it and how it changes us?What is it and how it changes us?

Medication Benchmarks: Medication Benchmarks: Selection of AntidepressantsSelection of Antidepressants Many options are possible:Many options are possible:

tricyclic antidepressants (TCAs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors selective serotonin reuptake inhibitors

(SSRIs), (SSRIs), nonselective serotonin–norepinephrine nonselective serotonin–norepinephrine

reuptake inhibitors (SNRIs), reuptake inhibitors (SNRIs), the selective norepinephrine reuptake the selective norepinephrine reuptake

inhibitors (selective NRIs)inhibitors (selective NRIs) other miscellaneous agents, such as other miscellaneous agents, such as

mirtazapine. mirtazapine.

Case of GeorgeCase of George

Military serviceMilitary service Industrial manager, polite, defines himself Industrial manager, polite, defines himself

a “medieval knight.” a “medieval knight.” First depression episode at 26, treated with First depression episode at 26, treated with

clomipramine, dose unknown.clomipramine, dose unknown. At 30 married with a daughterAt 30 married with a daughter At 45 return of depressive symptoms, At 45 return of depressive symptoms,

treated with fluvoxamine 200–300 mg and treated with fluvoxamine 200–300 mg and mirtazapine 15 mg mirtazapine 15 mg

Depression continues, loss of interest in Depression continues, loss of interest in work, difficulty with bi-polar daughterwork, difficulty with bi-polar daughter

Loss of daughter, divorce and loss of workLoss of daughter, divorce and loss of work At 48, suicideAt 48, suicide

First Treatment not EnoughFirst Treatment not Enough

Who responds to SSRI citalopram? Highly educatedCurrently employedCaucasian womenFew complicating psychiatric or

medical disorders. At least 70% of patients did not

respond.

Beyond Efficacy: The STAR*D Trial. By Thomas R. Insel Am J Psychiatry. available in PMC 2006 September 30.

First Treatment not EnoughFirst Treatment not Enough

Who responds to SSRI citalopram? Highly educatedCurrently employedCaucasian womenFew complicating psychiatric or

medical disorders. At least 70% of patients did not

respond.

Beyond Efficacy: The STAR*D Trial. By Thomas R. Insel Am J Psychiatry. available in PMC 2006 September 30.

First Treatment not EnoughFirst Treatment not Enough

Who responds to SSRI citalopram? Highly educatedCurrently employedCaucasian womenFew complicating psychiatric or

medical disorders. At least 70% of patients did not

respond.

Beyond Efficacy: The STAR*D Trial. By Thomas R. Insel Am J Psychiatry. available in PMC 2006 September 30.

Not George

Medication Benchmarks: Medication Benchmarks: Selection of AntidepressantsSelection of Antidepressants

70% not responsive70% not responsive Six weeks before efficacy can be Six weeks before efficacy can be

examinedexamined Sometimes 2-3 years searching for Sometimes 2-3 years searching for

right medicationright medication

Variability in OutcomesVariability in Outcomes

George is not alone, poor management of depression is affecting many.

What We Want?What We Want?

Medication That Works for MeMedication That Works for Me

Rethinking Role of DataRethinking Role of Data

Patient data

stored

Data of others

Patient data

retrieved

Care reminders

Patient info

displayed

EHR

Data warehousing

Discovery

ClinicalEducation

Care Decisions

Rethinking Role of DataRethinking Role of Data

Patient data

stored

Data of others

Patient data

retrieved

Patient info

displayed

EHR

Data warehousing

Discovery

ClinicalEducation

Care Decisions

Carereminders

Similarpatients

Rethinking Role of DataRethinking Role of Data

Patient data

stored

Data of others

Patient data

retrieved

Patient info

displayed

EHR

Data warehousing

Discovery

ClinicalEducation

Care Decisions

Analytics:care

forecasts

Similarpatients

Medication Benchmarks: Medication Benchmarks: Selection of AntidepressantsSelection of Antidepressants AgeAge GenderGender Race Race EthnicityEthnicity Concurrent Concurrent

drugsdrugs MethadoneMethadone BuprenorphineBuprenorphine

DietDiet GrapefruitGrapefruit

GeneticsGenetics CYP2D6CYP2D6 CYP2C19CYP2C19 CYP3A4CYP3A4 CYP1A2 CYP1A2

Concurrent Concurrent illnessillness CancerCancer DiabetesDiabetes

Medication Benchmarks: Medication Benchmarks: Selection of AntidepressantsSelection of Antidepressants Steps in AlgorithmSteps in Algorithm

1.1. Select characteristics that make Select characteristics that make patient different from normpatient different from norm

2.2. Calculate similarity to patients in Calculate similarity to patients in the databasethe database

Based on GMU patent. Confidential communication

ji,not jnot i,ji,

ji,ji, fff

fS

ba

Medication Benchmarks: Medication Benchmarks: Selection of AntidepressantsSelection of Antidepressants Steps in AlgorithmSteps in Algorithm

1.1. Select characteristics that make Select characteristics that make patient different from normpatient different from norm

2.2. Calculate similarity to patients in Calculate similarity to patients in the databasethe database

Based on GMU patent. Confidential communication

ji,not jnot i,ji,

ji,ji, fff

fS

ba

Number of

features matched

Number of

features

matched

Features in one but not the

other

Medication Benchmarks: Medication Benchmarks: Selection of AntidepressantsSelection of Antidepressants Steps in AlgorithmSteps in Algorithm

3.3. Reported average outcomes for Reported average outcomes for different anti-depressants different anti-depressants weighted by similarity of patients:weighted by similarity of patients:

Based on GMU patent. Confidential communication

Om = j=1, …, n Si,j Oj,m / j=1, …, n Si,j

Medication Benchmarks: Medication Benchmarks: Selection of AntidepressantsSelection of Antidepressants Easy to implementEasy to implement

8 lines of SQL code8 lines of SQL code Can work within any EHRCan work within any EHR

Concurrent analysisConcurrent analysis No need to export data. No need No need to export data. No need

for consentfor consent No need to use data warehousesNo need to use data warehouses

No need to require same data No need to require same data on all patientson all patients

Medication Benchmarks: Medication Benchmarks: Selection of AntidepressantsSelection of Antidepressants Easy to implementEasy to implement

8 lines of SQL code8 lines of SQL code Can work within any EHRCan work within any EHR

Concurrent analysisConcurrent analysis No need to export data. No need No need to export data. No need

for consentfor consent Current or warehoused dataCurrent or warehoused data

No need to require same data No need to require same data on all patientson all patients

Medication Benchmarks: Medication Benchmarks: Selection of AntidepressantsSelection of Antidepressants Easy to implementEasy to implement

8 lines of SQL code8 lines of SQL code Can work within any EHRCan work within any EHR

Concurrent analysisConcurrent analysis No need to export data. No need No need to export data. No need

for consentfor consent Current or warehoused dataCurrent or warehoused data

No need to require same data No need to require same data on all patientson all patients

Data SourceData Source

Sequenced Treatment Alternatives Sequenced Treatment Alternatives to Relieve Depression (STAR*D)to Relieve Depression (STAR*D) 4,041 outpatients with non-psychotic 4,041 outpatients with non-psychotic

depressiondepression 23 psychiatric and 18 primary care sites23 psychiatric and 18 primary care sites 12-week course of the SSRI citalopram 12-week course of the SSRI citalopram Adjunct or replacement treatment in Adjunct or replacement treatment in

three subsequent phasesthree subsequent phases

Technological FixTechnological Fix

Technology is availableTechnology is available Data is availableData is available Analytical procedure is simpleAnalytical procedure is simple

Will there be fewer George’s among us?

Transformation at Hand: Transformation at Hand: Suppose the Dog Catches with the CarSuppose the Dog Catches with the Car

Process changesProcess changes Confusion in respondingConfusion in responding Patient first?Patient first? Liability for follow upLiability for follow up

Organizational changesOrganizational changes FormularyFormulary Must have softwareMust have software Consent to excludeConsent to exclude

OtherOther FDA approvalFDA approval Publishing dataPublishing data

Informatics Can Be Informatics Can Be Anything You WantAnything You Want

Be Careful What You Wish ForBe Careful What You Wish For

What is 1+1?