Considering the Impact of Yet Another Proposal for Genetic Legislation
Last month we examined Massachusetts’ proposed Genetic Bill of Rights. Last week, we looked at a similar proposal to expand individuals’ property and privacy rights in genetic information proposed in the Vermont legislature. Today, we head west to California to examine another piece of recently introduced genetic legislation.
A New Padilla Proposal. The California proposal comes from state Senator Alex Padilla. If Padilla’s name sounds familiar, it is likely because he is the same Senator Padilla who introduced a widely discussed “bioinformatics bill” to the California legislature two years ago. That bill (S.B. 482) was drafted with the close participation of direct-to-consumer (DTC) genetic testing company 23andMe, and 23andMe and Senator Padilla later co-sponsored a policy forum in San Francisco on “genomics and the consumer” (at which I presented).
Unlike Padilla’s earlier effort, which would have significantly altered the regulatory environment for so-called “post-CLIA bioinformatics services” (basically, genetic interpretation performed after the generation of genetic genotype or sequence data in a CLIA environment), 2011’s effort (S.B. 559 (pdf)) will almost certainly be viewed as a much less controversial proposal.
Is the Genetic Rights Movement Picking Up Steam?
The movement to confer greater legal protection to individuals’ genetic information has added another participant. Last month, we examined newly introduced legislation in Massachusetts which, if passed, would create a “Genetic Bill of Rights,” significantly expanding Massachusetts residents’ personal property and privacy rights in their genetic information. Since then, in what the Council for Responsible Genetics has termed a “groundswell for genetic privacy building in states,” state legislators in both California and Vermont have introduced new legislation that would confer greater protection upon individuals’ genetic information.
What should we make of this three state “groundswell?” Although not identical in scope or substance to the Massachusetts Genetic Bill of Rights (“MA GBR”), both the Vermont and California proposals appear to reflect a concern (shared by the MA GBR) that, at least when it comes to the use and misuse of genetic information, the current system of federal oversight is inadequate. Then again, as the legislative findings section of the California proposal (pdf) puts it, perhaps “the current explosion in the science of genetics” simply “compels legislative action in this area.”
Surreptitious Genetic Testing: WikiLeaks Highlights Gap in Genetic Privacy Law
The top news story the past two weeks: the release of hundreds of thousands of confidential American diplomatic cables by WikiLeaks. While dissecting diplomatic maneuvering is not a traditional area of expertise for the Genomics Law Report, a pair of cables did catch our eye.
The first is primarily a curiosity: the allegation that Chinese authorities are spying on deCode Genetics, Iceland’s most prominent genetic research company and provider of the direct-to-consumer genetic testing service, deCODEme. Nobody seems to know exactly what China is looking to gain by clandestinely exploring Iceland’s genetic genealogy. You are welcome to speculate in the comments.
The second raises broader issues: the revelation that the State Department’s ongoing human intelligence collection directives include requests for “biometric information” on key world leaders, including United Nations arms inspectors, the Director General of the World Health Organization (WHO) and key advisors and aides to United Nations Secretary General Ban Ki-moon. A separate cable detailing intelligence collection priorities in Africa’s Great Lakes region clarifies that “biometric information” includes “health [data]…fingerprints, facial images, DNA, and iris scans.”
Not disclosed in the WikiLeaked cables: why the State Department wants the biometric data or whether any have been successfully obtained.
Surreptitious Testing: An Overview. The cables are, however, a reminder that the law surrounding the surreptitious collection and testing of biometric data, including DNA, remains extremely murky.
Germany Struggles to Find Balance in Promoting, Regulating Genetic Technologies
Last fall we reported on the passage of the Human Genetic Examination Act by the German Bundestag. We characterized the Gendiagnostikgesetz (GenDG), as the act is known in Germany, as “a clear example of what is known as ‘genetic exceptionalism’—the belief that genetic information is qualitatively different from other forms of personal or medical information—staking out a position near the paternalistic end of genetic regulation.”
The GenDG (pdf) took effect early this year and, until recently, little news of its impact on German law, policy or business has made its way across the Atlantic. Last week, however, several prestigious German scientific academies released a report entitled “Predictive Genetic Diagnostics as an Instrument of Disease Prevention.” The “Academy Group,” as the report’s authors refer to themselves, consists of the Leopoldina, the Berlin-Brandenburg Academy of Sciences and Humanities and the German Academy of Science and Engineering Acatech. Astoundingly, according to a recent editorial in the journal Nature, the report is the first from the group in its 350 year existence.
“From Gulf Oil to Snake Oil”: Congress Takes Aim at DTC Genetic Testing
It has been a busy week in Washington for direct-to-consumer (DTC) genetic testing companies. Following public FDA meetings and a new round of FDA device notification letters earlier in the week, representatives from three major DTC genetic testing companies (23andMe, Navigenics and Pathway Genomics) were hauled in front of Congress today to defend their companies, their industry and the practice of DTC genetic testing.
The hearing on “Direct-To-Consumer Genetic Testing and the Consequences to Public Health” was conducted by the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations. The meeting was chaired by Representative Bart Stupak of Michigan. Materials from the hearing, including a briefing memorandum, opening statements from Stupak and Representative Henry Waxman of California and witness testimony are available on the Committee’s website. Also available are materials from the Government Accountability Office (GAO) investigation into DTC genetic tests. These materials include the report the GAO submitted to Congress – “Direct-to-Consumer Genetic Tests: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices” (pdf) – as well as a YouTube video featuring excerpts from undercover phone calls made by the GAO to DTC companies as part of their investigation (both of which are discussed in detail below).
The Unexpected Impact of Genetics on the Business World
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.
Genomic Privacy and Re-Identification Redux
New research published this week in the Proceedings of the National Academy of Sciences from Loukides et al. offers up a new method for preserving individual privacy while linking genomic and healthcare data. (“Anonymization of electronic medical records for validating genome-wide association studies.”) Daniel Cressey of Nature News and Katharine Gammon of Technology Review have concise (and free) summaries.
As we’ve written earlier (“Back to the Future: NIH to Revisit Genomic Data-Sharing Policy”), the ability to link – and to share – genotype and phenotype data (including medical records, particularly treatment and outcome data) will be essential to the development of the next generation of genomic research. One of the most common ways to link genotype and phenotype data is to combine genomic data with electronic medical records (EMRs). A particular patient’s EMR may contain everything from basic biographical information to family medical history to current diagnoses, including ICD codes. When it comes to associating genes with medical conditions, researchers rely on International Classification of Disease (ICD) codes to categorize individual patients by disease type and search for shared genetic variations that might play a causal role.
Cracking the Codes. Obviously identifying information (e.g., biographical information) is generally required to be removed pursuant to HIPAA regulations. ICD codes, however, are sometimes retained for purposes of genetic association research and, in some circumstances, a set of otherwise anonymous ICD codes pulled from an EMR can be traced backwards to identify the specific individual supplying the codes.
What ELSI was New? Plenty.
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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Back to the Future: NIH to Revisit Genomic Data-Sharing Policy
As first reported by GenomeWeb, last week the NIH issued a “Notice on Development of Data Sharing Policy for Sequence and Related Genomic Data.” Although the title doesn’t exactly trip off of the tongue, the NIH’s announcement provides an opportunity to review where we are and where we have already been when it comes to genomic data-sharing.
At the heart of the NIH’s announcement is a desire to increase the availability of genomic datasets. From last week’s notice:
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Consistent with the NIH mission to improve public health through research and the longstanding NIH policy to make data publicly available from the research activities that it funds, the NIH has concluded that the full value of sequence-based genomic data can best be realized by making the sequence, as well as other genomic and phenotype datasets derived from large-scale studies, available as broadly as possible to a wide range of scientific investigators.
For NIH-funded genomic researchers, this language should have a familiar ring. In 2007, the NIH published a policy covering data-sharing for genome-wide association studies (GWAS) that required all NIH-funded GWAS research be deposited in a central data repository. Here’s the mission statement from the 2007 policy:
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Re-identification and its Discontents
Last fall, a paper from Homer et al. in PLoS Genetics made waves by demonstrating that it was possible, in principle, to identify an individual’s genomic data within a large dataset of pooled genomic data. Pooled or aggregated genomic data had previously been considered to provide individual research participants with a strong measure of privacy. The paper from Homer et al. produced an immediate reaction from the genomic research community, prompting the National Human Genome Research Institute (NHGRI) to immediately restrict pooled genomic data (pdf) that had previously been accessible (pdf) to the public. Other institutions including the Wellcome Trust and the Broad Institute quickly followed suit.
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