The big news from the past 24 hours is the death of Osama Bin Laden, which was reported late Sunday evening by President Barack Obama. That’s front page news the world over. But Genomics Law Report readers might be interested to note that DNA appears to have played a significant role in confirming that it was, in fact, Bin Laden who was killed in a shootout with U.S. military forces yesterday in Pakistan.
As reported by The Telegraph earlier today, Bin Laden’s identity was confirmed by government officials only after they matched DNA taken from the body in Pakistan with DNA extracted from a preserved tissue sample from Bin Laden’s sister, who died of brain cancer several years ago. The identification happened rapidly, but, according to Christie Wilcox in a guest post at Scientific American, that’s not all that surprising. Wilcox outlines, step by step, how such an ID could have easily occurred in under 5 hours.
We have covered the use of forensic DNA techniques numerous times here at the GLR, and regular readers know identification through partial or familial DNA matching is not without both social and scientific critics. However, lest there be any doubt, CNN reports that the Obama administration used several methods, including facial recognition and eyewitness corroboration, to positively identify Bin Laden.
With so many developments at the intersection of genomics and the law, there are often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here we recap several recent key developments and, at bottom, round up all of the recent tweets from @genomicslawyer.
The Continuing Threat of Decreased Science Funding. At least for the moment, the two houses of Congress appear, finally, to be edging toward a budget compromise that would bridge the $51 billion gap between the House bill (which passed at the beginning of March) and the most recent Senate proposal. That’s a good thing, given that the current continuing resolution is set to expire on April 8.
Nevertheless, it seems increasingly clear that federal science funding is unlikely to increase from its fiscal year 2010 levels, and funding almost certainly will not meet the targets President Obama set in his FY 2012 budget proposal.
Beginning this week, we are unveiling a new format for the Genomics Law Report’s regular Twitter Roundup. In addition to cataloging Dan’s @genomicslawyer tweets, we will also be offering short summaries of several key developments pulled from those tweets which, for one reason or another, did not find their way into a full-length post. Think of this as a combination between the always informative Friday Links posts at Genomes Unzipped and The Cross-Border Biotech Blog’s semi-regular feature “This Week in the Twitterverse,” which was the original inspiration for the GLR’s Twitter Roundup.
We have recently summarized efforts by two state legislatures to design regulatory schemes addressing issues raised by the proliferation of genetic information about individuals. New York’s effort addresses questions of insurance coverage for genetic testing. Massachusetts’ goes much further, calling itself a “Genetic Bill of Rights,”a title that accurately reflects its ambitions. In reviewing both of these proposals we have made the point that state-level legislation is no substitute for a coordinated and long-overdue federal-level approach.
But who will lead that coordinated federal effort? As we wrote recently, since the 2008 publication of a SACGHS report identifying major gaps in the regulation of genetic testing, that committee has been disbanded and no clear successor has emerged to champion these issues at the federal level. Last week, the National Human Genome Research Institute (NHGRI), which was originally created by the NIH to support the Human Genome Project, and is today tasked with advancing the understanding and application of human genomics, updated its long-term strategic plan for the first time since 2003 (pdf). Although a “critical part” of the NHGRI’s mission is the “study of the ethical, legal and social implications (ELSI) of genome research,” the Institute’s new roadmap barely touches upon ELSI issues, and dispenses with “legal and public policy issues” in a single sentence by noting the need for “collaborations.”
Direct-to-consumer (DTC) genetic tests are back on the FDA’s public radar screen. A month from today, the agency’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will meet to “discuss and make recommendations on scientific issues concerning [DTC] genetic tests that make medical claims.” Here is the Federal Register notice (pdf).
The two-day meeting, which is open to the public, will investigate the following topics:
- The risks and benefits of making clinical genetic tests available for “direct access by a consumer without the involvement of a clinician (i.e., without a prescription).”
- The different types of DTC or direct access tests (e.g., carrier screening, risk prediction in healthy persons, pharmacogenetics, etc.) that might “support differences in the regulatory approach.”
- The “level and type of scientific evidence appropriate for supporting [DTC] claims, including whether it should be different than” what is required for similar clinical genetic tests (presumably, non-DTC in vitro tests, including laboratory developed tests, or LDTs).
A complete agenda and list of speakers has yet to be published, but the fact that the FDA is singling out DTC genetic tests for specific attention is sure to be a welcome sign to many.
This past March Judge Robert Sweet handed down an unexpected summary judgment ruling in the Myriad gene patent litigation (see: Pigs Fly: Federal Court Invalidates Myriad’s Patent Claims). Myriad quickly appealed Sweet’s district court decision to the Court of Appeals for the Federal Circuit (CAFC).
After several months of courtroom quiet, the briefs began rolling in to the CAFC last week. Most, including Myriad’s own appellant brief (pdf), presented the argument we would expect. Myriad and its supporters frame Judge Sweet’s ruling as an erroneous application of settled patent law and policy that, if upheld, “would have far-reaching negative consequences” (pdf) for the continued development of biotechnology.
And then there is the United States government. In an amicus brief filed on Friday (pdf) the Department of Justice (DOJ), on behalf of the United States, dropped a minor bombshell. Contradicting the longstanding policy of the United States Patent and Trademark Office (PTO), the government’s brief argues that isolated human genes, without further modification, are a product of nature and do not constitute patent-eligible subject matter under § 101 of the Patent Act.
Meggan Bushee is a student at the Wake Forest University School of Law.
This past May, Congressman Patrick Kennedy (D-RI) and Congresswoman Anna Eshoo (D-CA) re-introduced a personalized medicine bill to the U.S. House of Representatives. The bill was originally introduced in 2006 by then-Senator from Illinois Barack Obama. While HR 5440, also known as the Genomics and Personalized Medicine Act of 2010 (GPMA 2010), has retained the name of the bill originally introduced by Senator Obama, its approach to the regulation of personalized medicine has taken a new direction.
GPMA 2010 is the fourth version of the GPMA since the original bill of 2006, and includes the most ambitious initiatives of all of its predecessors. Why has the GPMA re-surfaced after three prior versions failed to make it out of committee? According to Representative Kennedy, the bill has been re-introduced in response to increased public awareness and use of genomic tests. At present, GPMA 2010 is before the House Committee on Energy and Commerce. This is the same committee that recently conducted high-profile hearings to review the current state of the direct-to-consumer (DTC) genetic testing registry.
Earlier this week James Cass wrote a piece discussing forensic DNA profiling (“The Cost of Making Crime Not Pay: Obama, CODIS and Forensic DNA“). That article prompted GLR readers to write in and point out that, thanks to several recent developments, the next generation of forensic DNA investigations may increasingly involve the use of non-human DNA profiling techniques.
Last week, a paper in the Proceedings of the National Academy of Sciences presented research that every person – even twins whose DNA is practically identical – possesses a unique bacterial signature. It appears that traces of that bacterial signature can be recovered from household surfaces, including a computer keyboard, and potentially used to link a crime scene to a suspected criminal. The researchers’ findings are summarized in ScienceNOW (“CSI’s Latest Clue – Bacteria“).
Earlier this month President Barack Obama appeared on the television show “America’s Most Wanted” to discuss the creation of a national forensic DNA database. In his interview with AMW host John Walsh, President Obama expressed his strong support for a number of law enforcement initiatives, including a proposal to expand the compulsory DNA sampling of individuals arrested and charged with certain crimes.
In this post we’ll take a look at the current system of forensic DNA profiling, starting with the Combined DNA Index System (CODIS), which is the FBI program that oversees DNA profile databanking in the United States. It comprises databases at the local, state and national levels, with the National DNA Index System (NDIS) the crown jewel. The CODIS program operates as a powerful law enforcement tool but, in the eyes of some – including President Obama – it is not yet powerful enough. But even the existing CODIS collection, with its nearly eight million DNA profiles, poses a number of interesting ethical, legal and social issues.