Ethical & Legal Issues in Alzheimer’s Disease

1. Ethical & Legal Issues in Alzheimer’s Disease Dan Vorhaus December 7, 2010 Alzheimer’s Program 2010 National Press Foundation

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3. The Personal Genomics Landscape Application: clinical / patient care Delivery: licensed healthcare provider Clinical Clinical Application: improve genomic understanding Delivery: variable (researchers, clinicians, direct or not at all) Research Research Consumer Application: informational, educational (but not clinical) Delivery: direct to individual Consumer Unintended Common Feature: unintended exposure to genetic information Unintended

4. Your Doctor’s Office

5. Your Living Room ?

6. Your Own Research Project

7. And Countless Other Ways • Donor identification • Paternity testing • Genetic genealogy • Family planning

8. Genetic Testing for Alzheimer’s Disease • Two Types of Alzheimer’s Disease • Early-Onset AD (also known as “Familial Alzheimer’s Disease” or FAD) associated with mutations on chromosomes 21,14, 1. Autosomal dominant. • Late-Onset AD predicted by APOE mutations (ε2 < ε3 < ε4). However, not perfectly predictive. Other markers available. • Availability of Genetic Testing • Clinical testing to confirm AD and, in some situations, to evaluate cardiovascular disease (CVD) risk. • Research settings (e.g., REVEAL study, PGP). • Commercial settings (e.g., Smart Genomics, DTC sequencing). • Unexpected in 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).

9. The Personal Genomics Landscape & the Law Blurring Boundaries, Rapid Change Make This Inevitable…. Are DTC genomic products Consumer or Clinical personal genomics? (What about products targeted at Consumers but not delivered DTC?) What about findings of Clinical significance in genomic Research? (And if the data isn’t returned to participants?) If genomic Research is monetized, is it now Consumer personal genomics? Genetic Information

10. Federal Regulation Common Rule Hatch? CLIA HIPAA Congress Legislates Patent Act GPMA? FDCA GINA OPH? Agencies Interpret and Enforce

11. GINA’s Uncertain Impact • Significance: Only piece of federal legislation specifically targeting genetic information. • Prohibits: health insurers from using genetic information 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?

12. State Positive Law • Nondiscrimination and Privacy • 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 restrict discrimination in long-term care insurance on the basis of genetic information (even though GINA does not)1 • Direct to Consumer Testing • Regulated by roughly half of the states, inconsistent definitions • Significant differences in substantive terms, application and enforcement (e.g., clinical laboratory regulation, CLIA vs. NY) 1 http://www.ncsl.org/IssuesResearch/Health/GeneticNondiscriminationLawsinLifeDisability/tabid/14283/Default.aspx

13. State Common Law • Theories of Tort Liability • Breach of duties to warn of risks, disclose complete and accurate information • 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 between individuals, providers and companies develop • Evolving Standards • Duties to third parties (i.e., genetic relatives)? • Duty to report, interpret “incidental” findings?

14. The $1,000 genome is coming…

15. …and the law is not ready Technology  Science & Commerce  Law

16. AD: Uniquely Important, Challenging • Impact: 5.3 people have AD, 7th leading cause of death costs $172 BN annually (and all of those numbers are rising). • Fairness: how do we treat people fairly in an age of ubiquitous personal genomic information? Is the goal actuarial fairness (accurate risk prediction, 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 basis of clinical utility or personal utility? • Third Parties: Should third parties (e.g., genetic relatives, caregivers) have a right to know (or to avoid knowing) genetic information affecting long-term wellness? Whose consent is required to access, share genetic information?

17. Questions or Comments? dvorhaus@rbh.comor Genomics Law Reporthttp://www.genomicslawreport.com/