What ELSI is New?
The Genomics Law Report is proud to present What ELSI is New?, a special series featuring guest commentaries from industry, academic and thought leaders in the fields of genomics and personalized medicine. Each commentary in the series is a response to the following question: “What do you believe is the most important ethical, legal or social issue (ELSI) that must be addressed by the fields of genomics and/or personalized medicine?”
Modeled after the Nature Genetics 2007 Question of the Year, the series identifies a wide range of ethical, legal and social issues that must be addressed to fully realize the promise of genomics and personalized medicine. You can access all of the commentaries in the series by visiting the Table of Contents or by downloading our ELSI e-Book (pdf). We also encourage you to provide your own comments and to help us continue and expand this important discussion.
Self Explorimentation
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Mike Cariaso, SNPedia.
Anyone with $400 is now able to learn much about their own DNA. This door is already open, but we’ve not yet had time to determine where it leads. The first few steps are small, and seem to be within the bounds of what is broadly acceptable. Stepping further seems to go beyond what we can reliably know today.
A DNA variant named rs3892097 increases risk of Parkinson’s Disease when exposed to pesticides. Is my insurer/employer allowed/obligated to test for this genotype and to prevent me from working with materials which are particularly hazardous to me? Do I have the right to work around pesticides? Similarly rs1799807 increases sensitivity to nerve agents such as VX and Sarin, how should the military factor this into their planning?
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The participatory turn in medicine – Which letter in the alphabet?
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Barbara Prainsack, King’s College London Centre for Biomedicine & Society.
Leroy Hood recently predicted the emergence of ‘P4 medicine – predictive, personalized, preventive and participatory’.1 Particularly the final P in ‘P4’ seems to hit a nerve: Craig Venter already hailed the ‘democratization of genomics’2 as part of a participatory turn in medicine, and 23andMe launched a ‘Do-It-Yourself revolution’ in disease research.3
It is indeed a welcome development that growing numbers of people can access genetic and other health information (personalised and otherwise) relatively easily, and that specialised medical knowledge is no longer the prerogative of those with a professional education. (The blurring of the divide between ‘lay people’ and professional experts, which currently takes place in personal genomics, arguably accounts for some of the latter’s concern about this newly emerging market.) But the participatory turn in medicine is also indicative of an ongoing individualisation of responsibility in health care4: The more knowledge we can obtain, the more we will be expected to obtain, and to pay for.
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It’s my genome: should researchers be obliged to return genetic data to research participants?
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Daniel MacArthur, Wellcome Trust Sanger Institute and Genetic Future.
Alice signed up as a “healthy control” for a research project into the genetics of type 2 diabetes. During the project, researchers identified a variation in Alice’s BRCA1 gene that is known to be associated with a high risk of breast cancer. Alice is unaware that she carries this variant, and if she was told about it she would be able to take steps to minimise her risk of cancer.
It is clearly in Alice’s best interests to be given the option to be informed about this discovery – and yet in most research studies she would have no such opportunity. Instead, Alice is likely to have signed an informed consent form advising her that she will not receive any findings from the research study, and that indeed she has no automatic right to access any of the data generated from her DNA during the project.
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Why Are We Missing What Is Important In Personalized Medicine?
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Steven Murphy, Helix Health of CT.
A 33 year old man with anxiety comes to the office. He says he has some worsening of his anxiety. It causes chest pressure. I saw his brother last week for a physical. He told me his father had a heart attack at 50.
The TIMI score for risk puts him at a 0.8% all cause 30 day mortality risk. No big deal right? His Reynolds Risk? 2%. Do I send him for a genetic test? No. I send him for a stress test. Why? Family History.
There are more people with Family History, than with faulty SNPs.
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Privacy & Ownership of an Individual’s Personal Genetic Information
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Jennifer Sweeney, Knome, Inc.
As personal genetic information becomes increasingly accessible and affordable, the ownership and privacy of such data will emerge as a central issue in genomics. Is personal genetic information, stored within a centralized database where a third-party gatekeeper determines who has access, really still private? Who owns such data? Should the individual have control over how, when and where their information is used? In such cases, it certainly seems the individual may have forfeited ownership and rights to control access to their own data.
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Finding The Proper Place for Genetics in Insurance
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Mark Henderson, Science Editor for The Times and author of 50 Genetics Ideas You Really Need to Know.
It is a mark of the quality of the science fiction movie Gattaca that, 12 years after its release, so many ethical issues surrounding genetics are still seen through its prism. In Andrew Niccol’s dystopian vision, DNA divides society into “valids” and “invalids”, some of whom are decidedly more equal than others.
Concerns about such genetic discrimination are relevant to many ELSI discussions, but rarely more so than when the subject is insurance. The great fear is that genetic data could create an uninsurable underclass, denied mortgages and life and health cover because of genomic flaws beyond their control.
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Personalized Genomic Medicine and Health Care Justice
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Michelle L. McGowan Ph.D., Case Western Reserve University Department of Bioethics.
The most significant challenge to the promise of personalized genomic medicine hinges on the realization of health care justice. From a social justice perspective, meeting the basic health care needs of the population – locally and globally – is an urgent objective that dwarfs the goal of a genomic approach to medicine.
The challenge to proponents of personalized genomic medicine is to find a way to frame their aspirations and actions in a way that simultaneously moves towards realizing personalized medicine and global health care justice. However, the terminology and current direction of personalized medicine has the potential to hinder this effort.
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Education, Not Regulation, Will Benefit Consumers of Recreational Genetics
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Blaine Bettinger, Bond, Schoeneck & King and publisher of The Genetic Genealogist.
Genetic ancestry testing, the use of DNA to explore an individual’s recent or ancient genetic contributors, has been available to customers for almost a decade but has recently been a topic of much debate among bioethicists. The concerns often center around topics such as privacy, definitions of race, and emotional or psychological effects of test results, among others. These concerns, together with continuing advances in personalized genomics that have the potential to make our DNA an important part of how we shape our identity and interact with society, lead to the question of whether recreational genetics should be regulated in order to prevent any potential harms to consumers. Or, as some argue, will regulations hinder the field without providing any real benefit?
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The Direct to Consumer Disconnect: Why the genomics community is going to have trouble talking to patients and doctors alike
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Matthew Herper, Forbes.
We can sequence DNA cheaper and faster, and even deal with all the data.
But if genomics is really going to impact medicine, we’re going to have to start bridging the gap between the companies and scientists doing this early work and the traditional medical establishment. The genoscenti like to talk about how everyone should have access to his own DNA. Your genes are a part of you, they say. How could they belong to anyone else?
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Medical vs. “Recreational” Genomics: Drawing a Line in the Sand
This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Allie Janson, University Health Network/Mount Sinai Hospital’s Fred A. Litwin Family Centre in Genetic Medicine and DNA Exchange.
To me, one of the most interesting aspects of genomics is the potential for it to be both medical and recreational in nature. Direct-to-consumer companies have picked up on the recreational aspect of genomics and run with it—successfully marketing their service as a fun and interesting glimpse “inside oneself.” Understandably, the medical community has been, and will be, slower and more cautious about incorporating weak gene variant-disease associations into medical care. However, as the 1000$ genome comes barrelling towards hospital doors, physicians may no longer have a choice. Patients will present with a symptom and a genome print-out in hand, and demand answers.
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