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.

What ELSI Was New: MagCloud Edition

What ELSI is new (article)

There are now three ways to review last fall’s guest commentary series, What ELSI is New? You can read the individual commentaries online, download the entire series as a free e-book (pdf) or, by popular demand, order a bound copy of the series through MagCloud.

MagCloud allows publishers to create a glossy, bound magazine from a standard PDF and prints and ships copies on demand. MagCloud charges 20 cents per page plus any additional publisher markup (there is no additional markup for the What ELSI is New? series) for its service.

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What ELSI was New? Plenty.

What ELSI is new (article)From October 5 to December 8, 2009, the Genomics Law Report featured a series of thirty-six guest commentaries by industry, academic and thought leaders in the fields of genomics and personalized medicine. Entitled What ELSI is New?, the series, which we have organized into an e-book (pdf), asked each contributor to briefly respond 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?

For better or worse, that’s where the instructions ended. The invited contributors identified the ELSI of their choice and discussed (or not) their rationale for so selecting as they saw fit. In addition to refraining from substantive editing, we intentionally avoided coordinating commentaries. Although we encouraged independent submissions from a variety of contributors and deprived them of any advance knowledge of what others in the series would say, one of our hopes was that consensus would begin to form around certain key ethical, legal and social issues.

To some degree this occurred. In collecting the series for the convenience of readers who would like to have all of the contributions in one place (pdf), we have ultimately settled on six broad topic headings for the commentaries
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In Support of Open Access for Genomic Research

What ELSI is new (article)

This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by George Church, Harvard Medical School.

One of the recurring themes in this ELSI series has been the discussion of open-access vs. research-only models for genomic research (see Bobe, MacArthur, McCarty, Prainsack and Sweeney). Below I discuss the characteristics and advantages of, as well as obstacles to, an open-access data model for genomic research.

A. Self-access: Open-access and freedom of information are increasingly required by law. Medical research is increasingly holistic — integrating a variety of (identifiable) traits and molecular signatures. Genomics is just part of this, not particularly exceptional. Multi-purpose cohorts and biobanks are displacing single trait studies. Research volunteers are increasingly expecting to see their own data and what is being doing with it. So with respect to such desired transparency, projects can be classified as ranging from 1) “no access” (HapMap, 1000 Genomes, dbGAP), to 2) limited access and no vetting exam (ClinSeq, CPMC and REVEAL), to 3) full access based on obtaining a 100% score on an exam covering risks of data sharing and re-identification (PGP).


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Pre-implantation Genetic Screening: Socioeconomic Stratification and Equality of Opportunity

What ELSI is new (article)This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Austin Alexander, Siftgen, Inc.

As the era of personal genomics comes of age, genomic information will play an increasingly important role not only in medical decisions but also in reproductive decisions. Already, preimplantation genetic screening (“PGS”, also referred to as preimplantation genetic diagnosis or “PGD”) is being used to screen embryos prior to implantation to select those without known genetic diseases such as cystic fibrosis and Huntington’s disease. As the understanding of the genetic contribution to diseases and traits increases, and as the cost of full genome sequencing decreases, it will become feasible to use PGS to target the full spectrum of genetic diseases.
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Does a genomics that does not work for some mean a genomics that will not work for all?

What ELSI is new (article)This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Jenny Reardon, Department of Sociology and Center of Biomolecular Science and Engineering at UC Santa Cruz, and Stephanie M. Fullerton, Department of Bioethics and Humanities at the University of Washington.

The future promise of personalized medicine rests precariously on the care with which we pursue genomic research in the current moment. While a focus on legal protections and open access are important, we must also attend to fundamental questions about the constitution of human diversity at the genomic and social level.

This is clearly evident in the recent collision of open source genomics with privacy rights. While calls for unfettered data sharing have formed the ground for much biomedical research, the achievement of a genomic commons may create its own kind of blockages. For example, although it is finally against the law to use genomic information to discriminate in healthcare or employment, the Genetic Information Non-Discrimination Act does not protect against misuses related to long term care coverage, life insurance, membership in federally-recognized groups, or immigration. For these and related reasons many people remain wary of involvement in genomic research. “Open access,” in other words, may inadvertently close the door for many.
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How should we deal with the arrival of very common prenatal testing for a broad set of genetic characteristics?

What ELSI is new (article)This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Hank Greely, Stanford University.

Each year, about 60,000 pregnant women undergo prenatal genetic testing in the United States, out of more than 4.2 million live births. Within five years, new testing methods, made possible by the rise of cheap forms of genomic analysis, will be able to test cell-free fetal DNA from the pregnant woman’s blood. These tests, feasible as early as the fifth week of pregnancy, will require a simple 10 milliliter blood draw, avoiding the invasive procedures of amniocentesis or chorionic villi sampling, with their attendant high costs, discomfort, and miscarriage risks.
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“So… One Can Have Their Complete Genome Sequenced…Should I?”

What ELSI is new (article)This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Patrice M. Milos, Helicos BioSciences Corporation.

I’ve had a fascinating time reading these posts and it has taken me awhile to articulate a question I imagine many of you might, or will, have. I believe the above question will be front and foremost on people’s minds in the next two to three years. As genome sequencing costs continue to fall dramatically, we will arrive at our end goal of the $1000 genome… or perhaps even $100… shortly.

Yet it is just this one question which raises many more ELSI questions.

First and foremost – do I have a right to my genome sequence?

I have a fundamental belief that the answer is a resounding yes. Why should I have to worry about whether I can obtain the sequence of genes that may actually prove important for key decisions for me as well as my family?
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To the moon: In support of the genomic astronauts who will take us there.

What ELSI is new (article)This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Jason Bobe, Personal Genome Project.

At the frontiers of science and engineering, promising new technologies are becoming available that will help us address pressing problems in human health and well-being. As the recent history of personal computing has shown, technology is often the easy part. Once into the world, technologies tend to go careening down the well-beaten path toward “better, faster, and cheaper” on a journey that leads ultimately to everyone’s front door. Personal genomic technologies are no different. If you don’t have any DNA sequence of your own yet, you will soon and so will many of your family, friends, and neighbors (and pets too).

Making personal genomes useful is a much more formidable challenge. In medicine, we want to employ personal genomics in the development of therapies that eliminate disease and diagnostics that reduce illness through early detection or prevention. In our personal and family affairs, we want knowledge that enables us to lead fuller lives, to know how our own personal biology interacts with the varied environments and lifestyle choices that makes us who we are and connects us with others.
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FDA should develop consistent evidentiary standards for post-market labeling changes to include pharmacogenetic information

What ELSI is new (article)This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Stephanie Devaney, Genetics and Public Policy Center at Johns Hopkins University, and Gail Javitt, Berman Institute of Bioethics at Johns Hopkins University and Sidley Austin LLP*

A prescription drug’s labeling is the primary vehicle used by drug manufacturers to inform providers of the conditions under which a drug is safe and effective for use, and must be approved by FDA at the time the drug is approved. Post-market labeling changes may also require FDA approval depending on the type of change. Pharmacogenetics is a relatively new and complex field that regulators and drug sponsors alike are trying to navigate. In recent post-market labeling changes to include pharmacogenetic information, FDA has been inconsistent in the type and amount of data it has required to support the new claim. A clearer regulatory path is critical to encourage drug sponsors to invest in pharmacogenetic research and to ensure that health care providers get the information they need to get patients the right drug at the right dose at the right time.
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Genetic discrimination: problem or paradox?

What ELSI is new (article)This commentary in the Genomics Law Report’s ongoing series What ELSI is New? is contributed by Alison Hall and Caroline Wright, PHG Foundation.

Over the last decade, our acquisition of genetic knowledge has gathered pace; whole human genome sequencing is now within reach, as accessibility increases and prices tumble. One consequence has been to challenge existing conceptions of what the term ‘genetic’ actually implies. The popular perception that a person is shaped solely by their genes has been undermined by the sheer volume, complexity and mundane nature of much genomic information. Whilst genomics and personalised medicine have the potential to unlock copious biological secrets and yield enormous medical benefits, other forms of information (such as family history, medical imaging or other biomarkers) may be equally useful, predictive and personally sensitive.
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