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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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or
Genomics Law Reporthttp://www.genomicslawreport.com/
Questions or Comments?