Ethical Issues in Alzheimer's Disease (Daniel Vorhaus)

8/7/2019 Ethical Issues in Alzheimer's Disease (Daniel Vorhaus)

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Ethical & Legal Issues in

Alzheimers Disease

Dan VorhausDecember 7, 2010

Alzheimers Program 2010National Press Foundation


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and licenses associated with its components.Slide Concept by Cameron Neylon. Slide is ccZero. Available at:http://www.slideshare.net/CameronNeylon/permissions?nocache=5749


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The Personal Genomics Landscape

Consumer

Research

Clinical

Unintended

Clinical

Research

Consumer

Unintended

Application: clinical / patient careDelivery: licensed healthcare

provider

Application: improve genomicunderstanding

Delivery: variable (researchers,clinicians, direct or not at all)

Application: informational,educational (but not clinical)

Delivery: direct to individual

Common Feature: unintendedexposure to genetic information


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Your Doctors Office


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Your Living Room


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Your Own Research Project


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And Countless Other Ways

Donor identification

Paternity testing

Genetic genealogy

Family planning


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Genetic Testing for Alzheimers Disease

Two Types of Alzheimers Disease

Early-Onset AD (also known as Familial Alzheimers Disease orFAD)associated with mutations on chromosomes 21,14, 1. Autosomal dominant.

Late-Onset AD predicted by APOE mutations (2 < 3 < 4). However, notperfectly predictive. Other markers available.

Availability of Genetic Testing

Clinicaltesting to confirm AD and, in some situations, to evaluatecardiovascular disease (CVD) risk.

Research settings (e.g., REVEAL study, PGP).

Commercialsettings (e.g., Smart Genomics, DTC sequencing).

Unexpectedin a variety of contexts (e.g., whole-genome sequencing).

Impact of Genetic Testing (specifically APOE status)

A good direct predictor of nursing home admission and indirect predictor of

long-term care need/use.

Alters individual long-term care insurance behavior(adverse selection).


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The Personal Genomics Landscape & the Law

GeneticInformation

Are DTC genomic products Consumer orClinical personal genomics? (What aboutproducts targeted at Consumers but not

delivered DTC?)

What about findings of Clinical significance ingenomic Research? (And if the data isntreturned to participants?)

If genomic Research is monetized, is it nowConsumer personal genomics?

Blurring Boundaries, Rapid ChangeMake This Inevitable.


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Federal Regulation

CLIA

FDCA

HIPAA

GINA

Common

Rule

GPMA?

Congress Legislates

Agencies Interpret and

Enforce

Patent

Act

Hatch?

OPH?


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GINAs Uncertain Impact Significance: Only piece of federal legislation

specifically targeting genetic information.

Prohibits: health insurers from using geneticinformation to deny coverage or set premiums

or payment rates (Title I) and employers from

requesting genetic information or using it in

hiring, firing and other employment decisions

(Title II).

Not Covered: Long-term care, life & disability

insurance. Military, VA.

Not Yet Known:

How will GINA impact employers, insurers and individuals? Enforcement?

Will GINA be extended (e.g., long-term care)? Is it necessary to do so?

How will future healthcare reform (e.g., the CLASS Act to create public long-term care

insurance) interact with GINA, genetic information?


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State Positive Law

Nondiscrimination andP

rivacy Genetic/medical privacy statutes overlap with existing federal and

state regulations of medical, genetic information (e.g., GINA,HIPAA)

For example, a 2008 NCSL study identified 9 states that restrictdiscrimination in long-term care insurance on the basis of genetic

information (even thoughGI

NA does not)

1

Direct to Consumer Testing

Regulated by roughly half of the states, inconsistent definitions

Significant differences in substantive terms, application andenforcement (e.g., clinical laboratory regulation, CLIA vs. NY)

1http://www.ncsl.org/IssuesResearch/Health/GeneticNondiscriminationLawsinLifeDisability/tabid/14283/Default.aspx


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State Common Law Theories of Tort Liability

Breach of duties to warn of risks, disclose complete and accurateinformation

Wrongful life / birth (carrier screening), products liability (sperm banks)

General negligence

Medical Malpractice the Doctor / Patient Relationship

Duties to patients much greater than duties to research subjects

Line becomes blurred as non-traditional advisory relationships betweenindividuals, providers and companies develop

Evolving Standards

Duties to third parties (i.e., genetic relatives)?

Duty to report, interpret incidental findings?


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The $1,000 genome is coming


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and the law is not ready


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AD: Uniquely Important, Challenging

Impact: 5.3 people have AD, 7th leading cause of death costs $172 BNannually (and all of those numbers are rising).

Fairness: how do we treat people fairly in an age of ubiquitous personalgenomic information? Is the goal actuarial fairness (accurate riskprediction, insurance pricing) or moral fairness (individuals lack control over

their genes)?

Utility: if we employ a risk-based approach to genetic testing regulation,how is utility incorporated? Do we regulate (e.g., grant access) on the basisofclinical utilityor personal utility?

Third Parties: Should third parties (e.g., genetic relatives, caregivers) havea right to know (or to avoid knowing) genetic information affecting long-term wellness? Whose consent is required to access, share geneticinformation?


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[email protected]

or

Genomics Law Reporthttp://www.genomicslawreport.com/

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Ethical Issues in Alzheimer's Disease (Daniel Vorhaus)

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