Each week there are a number of stories and developments that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Below is a recap of what I was Tweeting this week @genomicslawyer. Also remember to check out the Tweet’s from this week’s GET Conference (Past, Present and Future of Genomes, Environments and Traits: 140 Characters at a Time).
- Too much data, too few drugs. Summary of Sage Congress from @Duncande: http://bit.ly/9cO74X (HT @sagecongress)
- At Genetic Future (@dgmacarthur), Kai Wang responds to McClellan & King GWAS critique: http://bit.ly/brkd2w
- RT @genetics_blog: More on the McClellan / Claire-King GWAS essay http://goo.gl/fb/6Pn1i
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In what appears to be the first publicly identified case of its kind, a Connecticut woman has accused her employer of violating the recently enacted federal Genetic Information Nondiscrimination Act (GINA). According to a story in the Boston Herald (discovered thanks to a tip from Matt Mealiffe), 39-year-old Pamela Fink received an elective double mastectomy last year after testing positive for mutations in her BRCA2 gene associated with an increased risk of breast cancer. Fink alleges that, despite giving her “glowing evaluations for years,” her employer, MXenergy, “targeted, demoted and eventually dismissed her when she told them of the genetic test results.”
GINA, which was passed by Congress in 2008 and took effect last year, represents the most comprehensive effort to date to regulate the use of genetic information by employers (Title II) and health care insurers (Title I). Under Section 201(a)(i) of GINA, employers with more than 15 employees may not “discriminate against any employee with respect to the compensation, terms, conditions, or privileges of employment…because of genetic information.”
The first annual Genomes, Environments, Traits (GET) Conference took place yesterday. The GET Conference was an incredible success, with panels, breakout sessions and presentations from all manner of genomic pioneers and futurists, as well as a tremendous audience, both in person and online. In the next few days I’ll share a few thoughts about what we learned at the 2010 GET Conference, as well as what we might expect by the time the 2011 event rolls around. There will also be video from portions of the GET Conference available soon.
In the meantime, if you missed the conference, there was plenty of live Twitter coverage. Everything I tweeted from @genomicslawyer can be found below, and there’s much more at the #GET2010 twitter notebook. Thank you to all those who helped cover the conference online, including GET Conference pioneers (Rosalynn Gill, Misha Angrist), moderators (Carl Zimmer, David Dobbs, Dana Waring Bateman), journalists (Edward Winstead, Emily Singer, Kevin Davies, Aaron Rowe), sponsors (Priscilla Oppenheimer), exome sequence winners (Jonathan Eisen) and many, many more.
Now for Genomes, Environments and Traits in 140 character snips:
Each week there are a number of stories and developments that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In addition, this past week I spoke at the 9th Annual Bio-IT World Conference, and provided live updates from several of the other sessions at the conference. So, this version of the Weekly Twitter Roundup comes in two sections: the regular roundup followed by my tweets from Bio-IT World.
Part I: A recap of the standard @genomicslawyer Tweets:
- A roundup of the DNA Day happenings from @gw_dailyscan: http://bit.ly/c3xgtU
- RT @phylogenomics And the @23andme DNA day discount of 99$, offline for a few minutes, is back
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Pulitzer Prize-winning journalist Amy Harmon, of The New York Times, reports that a long-running dispute between Arizona State University (ASU) and the Havasupai Indians over the allegedly improper research use of DNA from members of the tribe has been settled.
The research began two decades ago, ostensibly to search for a genetic variant that might be contributing to the increasing rate of diabetes in the tribe. The diabetes research proved unfruitful, but the blood donated by the Havasupai tribe members, and the DNA extracted from it, led to a number of follow-on research projects, grants and publications. It was that research – including searching tribe members’ DNA for variants linked to schizophrenia, and inferring the likely ancestral origins of the tribe’s founders – that led to lawsuits, millions in legal fees and, ultimately, the settlement.
Implications of the Havasupai Settlement. Harmon’s article provides a concise background to the dispute, and briefly describes the $700,000 settlement between ASU and the tribe to “remedy the wrong that was done.” Harmon and unnamed “legal experts” suggest that the settlement is significant because “it implied that the rights of research subjects can be violated when they are not fully informed about how their DNA might be used.”
In some respects, this is a trivial conclusion. One of the most important and well-known elements of the Common Rule – the regulatory regime that governs federally-funded human subjects research – is that researchers must seek, and participants provide, informed consent. Participants that are uninformed cannot provide valid consent and, thus, their rights as subjects are violated. In that respect, at least, the Havasupai case tells us nothing new. (I have not seen the settlement, but I doubt that it will (a) be made public or (b) contain an express admission of guilt from ASU, both factors that will limit its relevance to future similar scenarios.)
Recent advances in genetic science are remarkable. In 2003 the first full human genome was sequenced after 13 years of work at a cost of over $3 billion. Today, the cost to sequence any individual’s entire genome is approaching $1,000. Genetic tests for specific genes linked to cancer and other diseases exist today and many more are being developed. We hear of a new era of “personalized medicine” in which drugs and therapies will be prescribed based on the individual patient’s specific genes.
All of this may seem to have little direct relevance to companies outside of biotechnology. However, the development of genetic knowledge and technology already has spawned new laws, regulations and patent uncertainties that impact almost all businesses in some way.
Privacy and Nondiscrimination. The federal Genetic Information Nondiscrimination Act of 2008 (GINA) represents the most comprehensive effort to date to regulate the use of genetic information. GINA initially only prohibited health insurers and group health plans from using genetic information to deny coverage or set payment rates. Another section, which just became effective in November 2009, affects all private and public employers with more than 15 employees.
In honor of DNA Day, the Genomics Law Report is completing its transformation into a one stop shop for the best in blog wrangling by hosting Scientia Pro Publica #26 and Blawg Review #260 in the same week. We think it fitting that these two august reviews should appear side-by-side at the GLR, which itself sits firmly at the intersection of science and the law.
For those unfamiliar with Scientia Pro Publica, it is a traveling compilation of the best blog writing targeted to the public about science, medicine, the environment and technology. Though more recently arrived, it is to science blogging what Blawg Review is to legal blogging. Our hope is that pairing the two will encourage all of our readers, regardless of background, to explore some of the best writing from previously unknown corners of the internet.
The occasion for this 25th 26th edition of Scientia Pro Publica – DNA Day – is one that is doubtless well-known to scientists, but if you’d like to know more please see the introduction to Blawg Review #260. As for the semi-creative counting, earlier this month Scientia Pro Publica featured a pair of 24th editions: one by Andrew at 360 Degree Skeptic and another by (a different) Andrew at Southern Fried Science. Which makes this, technically, the 26th edition of Scientia Pro Publica. If there’s one thing a lawyer hosting a science blog review can contribute it’s an increased sensitivity to technicalities. On to the submissions!
The Genomics Law Report is pleased to host the 260th Blawg Review. For regular GLR readers who are unfamiliar with the Blawg Review concept, it’s the longest-running weekly recap of legal blog posts in cyberspace. Each week, a different legal-related blog (also referred to as a blawg or, in the GLR’s case, an Internet journal) hosts Blawg Review, highlighting the most interesting posts from the previous week. Think of it as an enhanced version of our regular Weekly Twitter Roundup.
The occasion for this week’s Blawg Review is DNA Day 2010. For regular Blawg Review readers who may not be familiar with DNA Day, the event was established by Congressional resolution in 2003 to commemorate the 50th anniversary of the description of the double-helix structure of DNA and to celebrate the publication of the final consensus human genome sequence produced by the Human Genome Project.
This year’s DNA Day (April 23rd) is generating more publicity than usual as it coincides with the 10th anniversary of the draft human genome sequence. (Perhaps it makes sense to peg anniversary celebrations to the draft publication, as the final human genome sequence is still being completed seven years after its publication.) Many of the genomic pioneers from this past decade, as well as decades prior, will be gathering in Cambridge, MA next week at the GET Conference to take stock of how far the science and commerce of genomics has come, and project where it is heading in the decades to come.
So, pick your favorite anniversary – 57 years since the double helix, 10 years since the draft genome, 7 years since the final genome or 5 years since the first Blawg Review – and join us as we looks back at the week that was in blawging.
Each week there are a number of stories and developments that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here’s a recap of what I was Tweeting this week @genomicslawyer:
- RT @DukeIGSP: International Cancer Genome Consortium plans to sequence 25,000 cancer genomes. http://bit.ly/dazRAJ
- RT @dgmacarthur: Median age of 35,000+ people in @23andMe database is 55. Eriksson #networkbiology /via @bioitworld
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This afternoon, the journal Genetics in Medicine released an online-only supplement analyzing the relationship between gene patents and genetic testing. The bulk of the issue is devoted to a series of 8 case studies surrounding 10 clinical conditions. The case studies were undertaken over the past several years by researchers at Duke University’s Center for Public Genomics, and were led by Robert Cook-Deegan.
The Case Studies. Those who have been following the gene patenting debate for the past few years may recognize the case studies. They were released in largely their current form in March 2009 as a lengthy appendix to the draft report on “Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests” (pdf) prepared by the Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS).
The SACHGS report has since been finalized and, as we have discussed, was submitted to HHS Secretary Kathleen Sebelius with a series of recommendations, including exemptions to patent infringement liability for clinical care and research. If adopted, those recommendations would significantly reshape the gene patent and licensing landscape.