What the FCC’s Broadband Report Means for Genomics and Personalized Medicine
The Federal Communications Commission’s (FCC) National Broadband Plan was released to Congress today. (Depending on your perspective, that’s either one day ahead or 30 days behind schedule.) What, you might ask, does a broadband report prepared by an agency better known for handing out fines in the aftermath of wardrobe malfunctions have to say that could possibly interest the Genomics Law Report?
For most of the broadband plan’s 376 pages (pdf) the answer is “nothing at all.” However, Chapter 10 focuses on Health Care (pdf), with several discussions of potential relevance to the future of genomics and personalized medicine, at least in the United States. The bulk of the chapter is devoted to issues of indisputable importance – e-care, health IT, mobile and rural healthcare delivery, for instance – that will be capably covered elsewhere. (mobihealthnews, for instance, is already providing coverage of aspects of the plan that will impact mobile health care: here and here.) However, Section 10.4 (“Unlocking the Value of Data”) offers up two important themes that are relevant to how at least one government agency views the future of genomics and personalized medicine.
Long’s Op-Ed on Personal Genomics Comes Up Short
In an editorial in the Time’s of London’s Sunday edition – “When DNA means do not ask” – columnist Camilla Long took note of Glenn Close’s decision to sequence her genome. Long’s column begins with gossipy comments appropriate to her usual home turf (which is not science journalism). But she soon gets into territory clearly unfamiliar to her, focusing on what she perceives as the increasing commercialization of personal genomics and the broader failures of genetic information to provide satisfying explanations or cures for complex diseases.
Long’s column is a seriously one-sided and misinformed portrayal of not only personal genomics in the direct-to-consumer (DTC) context but also of the utility of genetic information in any context — clinical, commercial or otherwise. At Genetic Future, Daniel MacArthur’s response (“Willful ignorance is not an effective argument against personal genomics”) is every bit as accurate as it is scathing, and appropriately characterizes Long’s writing as “a true masterpiece of unsupported criticism, and an ode to willful ignorance.”
The Texas Newborn Bloodspot Saga has Reached a Sad – and Preventable – Conclusion
Contributed by Ann Waldo, Senior Counsel at Genetic Alliance.
In late February, the state of Texas incinerated 5.3 million newborn bloodspots.
The background – the Genomics Law Report has had several posts (here and here) about the ongoing situation involving 5.3 million newborn bloodspots in a state biorepository in Texas. Often referred to as “residual” bloodspots, these are the tiny dried bloodspots left over after states conduct mandatory screening for specified diseases. State practices regarding retention of the residual bloodspots vary widely, with some destroying them promptly and others storing them indefinitely. Where post-screening use of the bloodspots occurs, the most common use is for quality assurance and quality control of the screening tests. Some states also permit the release of small sets of bloodspots for research.
Any such research must be done in compliance with the federal Common Rule applicable to clinical research and HIPAA, the federal medical privacy law. To simplify these laws’ complex requirements – what researchers must do depends on whether the samples or information will be made available in an identifiable or de-identified form. If a researcher receives identifiable information, then informed consents, privacy authorizations, and Institutional Review Board (IRB) reviews are mandatory. If the researcher receives only de-identified samples or information, no parental consent or privacy authorizations are required, although some states, including Texas, still insist on IRB review.
Weekly Twitter Roundup
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:
- Me too! RT @blaine_5: I’m honored, thank you! RT @AccessDNA: Blogs we love: http://bit.ly/bXa218 @dgmacarthur @nsgc_org @alliejanson
- Why the State of Personal Genomics is Not as Dire as You Think: http://bit.ly/dtqTes
- RT @dgmacarthur: Wolfram Alpha has put together a new gene search tool: http://bit.ly/bqzyJt Very limited; colour me underwhelmed.
- Collins, Lander Botstein to share Albany Medical Center Prize: http://bit.ly/dlIhrT
- RT @dgmacarthur: Genetic Future post: Celebrity genomics without the Y chromosome: Glenn Close has her genome sequenced http://bit.ly/bF3DrJ
- RT @dgmacarthur: Genetic Future post: Disease hunting with whole genome sequences: the good news, and the bad news: http://bit.ly/b7k7Bw
- Update from @lindaavey on forthcoming (?) New York Times article and personal genomics: http://bit.ly/cdtxMG
- re: NEJM & Science WGS papers released today, @ivanoransky has a nice column on the shifting embargo deadlines http://bit.ly/99QjcY
Read the rest of this entry »
Why the State of Personal Genomics is Not as Dire as You Think
Another Tale of the Struggle of Personal Genomics, Full of Sound and Fury, Signifying…What? After a while, the personal genomics news cycle can begin to feel predictable. Recently, and not for the first time, there have been rumblings that personal genomics pioneer 23andMe is struggling. The most recent “news” appears to be a December SEC filing disclosing a $4 million payment to an unidentified 23andMe executive. Gene Expression and BNET have taken the opportunity to recycle some of the company’s previous financial struggles, including co-founder Linda Avey’s departure and a well-publicized round of fall layoffs, and to speculate broadly about the state of morale at the company in addition to the well-being of the personal genomics industry more generally.
Avey herself, perhaps unintentionally, has fueled speculation that something may be afoot with a pair of recent posts (the original post has now been combined with an update) on her own blog. Avey has launched a preemptive strike against what appears to be an upcoming New York Times piece that will “question[] the viability” of the personal genomics industry and “hits too close to home” for Avey not to comment. (Or, as GenomeWeb headlines it, Linda Avey Versus the New York Times.)
Perhaps all of the smoke signifies a smoldering fire at 23andMe. Then again, it may represent nothing more than periodic reverberations from the social media echo chamber, where common memes are repackaged and recycled at regular intervals.
Weekly Twitter Roundup
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. Last week, thanks to a particularly impressive confluence of client demands, no stories found their way into either full-length postings or Twitter updates. However, after a brief hiatus, the Weekly Twitter Roundup is back. This week we have a plethora of Tweets from @genomicslawyer that highlight developments that caught my eye as I was wading through an RSS backlog of over 3,000 items. Enjoy.
- AUS company offers discounted genetic tests if you’ll share the information with your insurers. http://bit.ly/cRmkq3 Impt GINA implications.
- Another national biobank in Scandinavia? Norway contemplating commercialization of national biomarker resources: http://bit.ly/cNaDZR (2/18)
- Going global, @PathwayGenomics partners with Colombian lab to offer DTC genetic testing: http://bit.ly/cziLCQ? (GenomeWeb, 2/18)
- London Sperm Bank brand designed by Silk Pearce http://bit.ly/agYAU6 (HT @MishaAngrist) As donor anonymity declines, will PR fill the void?
- Explaining genetics to consumers @PathwayGenomics licenses Harvard-developed content for DTC genetic test reports: http://bit.ly/cnw4WP
- Pin the Egg on the Sperm: Couple turns to social media, friends to help defray the cost of IVF/PGD: http://bit.ly/d4hcNB (SFGate, 2/5)
Read the rest of this entry »
The Benefits and Limits of Non-Disclosure Agreements
This commentary in the Genomics Law Report’s ongoing series Bench to Market is contributed by Matthew S. Churchill, Robinson, Bradshaw Hinson, P.A.
The last few articles in the Bench to Market series discussed capital raises and licensing-out arrangements that facilitate an entrepreneur’s commercialization of a new product or process. To obtain capital or a licensing arrangement, an entrepreneur must often share a business plan and confidential information about the proposed product or process with potential investors or licensees. The entrepreneur should insist upon binding non-disclosure agreements that prohibit both the disclosure and misuse of such information, before disclosing any such valuable information.
While some inventors may hold intellectual property rights, such as patents, to protect their proprietary information, many entrepreneurs rely on trade secret protection early in the commercialization process. See our recent article, “Can You Keep a Secret?” Non-disclosure agreements are fundamental to trade secret protection, as they demonstrate that inventors have taken reasonable steps to hold their valuable proprietary information in confidence.
The Texas Newborn Blood Spot Saga Continues
Contributed by Allison Williams Dobson of the Center for Genomics and Society at the University of North Carolina at Chapel Hill.
The Texas Department of State Health Services (DSHS) could soon face a new federal lawsuit in light of the discovery that it sent 800 anonymous newborn blood samples to a U.S. military DNA lab in 2003 and 2007. As discussed in a post by Adam Doerr on February 2, Texas Civil Rights Project lawyer Jim Harrington successfully negotiated a settlement in 2009 to have DSHS destroy 5.3 million newborn blood samples because it did not obtain informed consent from parents to use the samples for research. Now DSHS has come under criticism over samples it had already released for approved research.
The Texas Tribune reported last Monday under the headline “DNA Deception” that its review of nine years’ worth of e-mails and internal documents, obtained under state sunshine laws,1 revealed a DSHS agreement to help the military build a national mitochondrial DNA (mtDNA) database. The Armed Forces DNA Identification Laboratory claims a legitimate research purpose for the newborn DNA samples—to improve the identification of missing person remains through analyses of highly stable mtDNA.2 Because mtDNA generally lasts longer in a wider variety of tissues than nuclear DNA, it is also more likely to be recovered from particularly old or decayed remains.
