Precision Medicine: Its Promises and Pitfalls Melissa S. Creary, PhD, MPH Health Management and Policy U-M School of Public Health
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1 Precision Medicine: Its Promises and Pitfalls Melissa S. Creary, PhD, MPH Health Management and Policy U-M School of Public Health
2 Today s Outline 1. How did we get here? 2. Personalized vs. Precision 3. National Initiative 4. U-M Precision Health Initiative 5. Ethical Concerns and Other Problems 6. Resources 7. Question and Answer
3 How did we get here? Human Genome Project ( ) o identify all the approximately 20,000-25,000 genes in human DNA; providing the genetic blueprint for a human being o determine the sequences of the three billion chemical base pairs that make up human DNA; o store this information in databases; o improve tools for data analysis; o transfer related technologies to the private sector; and o address the ethical, legal and social issues that may arise from the project.
4 How did we get here? Human Genome Project ( ) o U.S. National Research Council Mapping and Sequencing the Human Genome (1988) o $3 Billion o Supported by U.S. Department of Energy, the U.S. National Institutes of Health (NIH), international and domestic collaborators and spurred by private competition o 15 years working draft produced in 2000
5 What the HGP gave us o Deeper understanding of medicine o Genomic architecture of genetic diseases (rare easier than common) o Better, more efficient, cheaper technologies o Ways to better think about data management and security o The next next frontiers: proteomics, pharmacogenomics, the microbiome, epigenome
6 What the HGP gave us o Shortcut that linked particular gene variants with specific diseases GWAS (genome-wide association studies) o Genomic Medicine Medical discipline that involves using genomic information about an individual as part of their clinical care
7 Personalized vs. Precision Personalized Medicine implies the prospect of devising a different treatment for each individual patient On one hand, that s how medicine is practiced every day, and on the other, it s a complete fallacy. - David Altshuler, geneticist, Broad Institute in Cambridge, Massachusetts
8 Personalized vs. Precision focuses on classifying individuals into subpopulations that differ in their susceptibility to a particular disease or in their response to a specific treatment an approach to integrating clinical and molecular information to understand the biological basis of disease enable more patient-centered clinical practice more research-oriented vs. more clinical practiceoriented.
9 Precision Medicine o GWAS studies are too limited o More data is necessary from many more people o Superimpose the entire genome and that data with: family history microbiome epigenome
10 National Initiatives: PMI o Announced at the 2015 State of the Union address o Lead by the White House with an all of government effort o Guiding Principles Creating a dynamic and inclusive governance structure Building trust and accountability through transparency Respecting participant preferences Empowering participants through access to information.
11 National Initiatives: All of Us o Name Change in October 2016 o Resides primarily within the NIH ($130 M) o Goal: 1 Million participants for the largest longitudinal study in the history of the United States All of Us represents the hope for all of us to come together to change the future of health care. The more people across America that participate, the more data they contribute to this research platform, and the more researchers who tap into the data, the greater our chances of unlocking medical breakthroughs.
12 Core Values Participation is open to all. Participants reflect the rich diversity of the U.S. Participants are partners. Participants have access to their information. Data will be accessed broadly for research purposes. Security and privacy will be of highest importance. The program will be a catalyst for positive change in research. Volunteers will contribute their health data and biospecimens to a centralized national database National launch Spring 2018 Democratizing Data Citizen Science
13 Why Now?
14 U-M Precision Health Initiative Language Matters: Precision Health vs. Precision Medicine Precision health at the University of Michigan expands far beyond medical treatment to include prevention, implementation, and community health. This initiative actively bridges these areas by promoting multidisciplinary collaboration among faculty across the university.
15 U-M Precision Health Initiative
16 U-M Precision Health Initiative
17 U-M Precision Health Initiative
18 U-M Precision Health Initiative
19 Ethical Concerns and Other Problems 1. Benefits will be unevenly distributed o Socioeconomic status o Geography o Race o Gender
20 Ethical Concerns and Other Problems 2. Participant Engagement o Not subjects Partners o Building trust o Continuous measurement :: continuous consent o Participant fatigue o Diversity
21 Ethical Concerns and Other Problems 3. Data Collection, Security and Privacy o Large amounts of data to be managed o Provision of individual level data o Social media integration o Centralized records
22 Ethical Concerns and Other Problems 4. Emphasis on Biological Difference/Citizenship o Lessons learned from HGP o Genetic profiling o New modes of discrimination o Immigration
23 Ethical Concerns and Other Problems 5. Bounded Justice (Creary, 2016) An attempt to distribute health rights without disturbing the underlying mechanisms that generated initial inequalities
24 Resources 1. All of Us: 2. U-M Precision Health: 3. Findings-SPH s Contribution to PH Reading List Available
25
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