• 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
• Whole-genome sequencing to trace disease genes. Good coverage from @bioitworld (http://bit.ly/9nBVcV) and @markgfh (http://bit.ly/9tch39)
• Provocative article in PNAS on the role of free will in human behavior & the criminal justice system: http://bit.ly/cjmPeY (HT @neandrothal)
• The Utah release is actually dated 3/9 RT @matthewherper: @ivanoransky @edwardwinstead @djsampson Genomics release is an embargo break.
• RT @drjonboyg: @DukeIGSP @genomicslawyer Lee Rowen presented that data at Personal Genomes last year, elegant and fascinating story
• “Researchers Sequence for First Time Genome of Entire Family” http://bit.ly/ckh4kC (Family of 4; seq via @CompleteGenomic; HT @DukeIGSP)
• RT @nutrigenomics, @BioMedCentral, @GenomeBiology New tool for handling genotype & phenotype data published http://bit.ly/c7vUbz
• RT @geneticalliance: Vote #raredisease in the 2010 Change.org Top Ideas Contest. Vote now through 3/12 http://bit.ly/96Xe6b
• Excellent breakdown of whole-genome sequencing marketing segmentation in 2010: http://bit.ly/bXzVzl (HT @lukejostins)
• RT @genetics_blog: Statistics for a changing world: Google Public Data Explorer in Labs http://bit.ly/cNOrS5
• RT @ldtimmerman: Lee Hood’s Institute for Systems Biology pockets $6m gift from anonymous VC. http://bit.ly/cTtren
• Q&A w/ Leroy Hood in @techreview: A Vision for Personalized Medicine & a teaser for the P4 Medical Institute: http://bit.ly/b4fNDx
• RT @tgoetz: RT @cwhogg: WebMD launches WebMD Health Exchange, a social networking platform for its 60M users http://bit.ly/cPuOoW
• RT @DukeIGSP: A cheaper and more sensitive DNA-based method to track cancer in blood. @nytimes http://nyti.ms/9QWJ47
• Excellent discussion re: Faces of America, genetic ancestry testing & the “right not to know” over at Genetic Future: http://bit.ly/b75vBe
• RT @dgmacarthur: RT @MishaAngrist: It’s alive: http://bit.ly/960jvq Still hard to imagine Kari Stefansson playing 2nd fiddle to anyone…
• Patent disputes could trip up genome wide scans for disease http://bit.ly/az1gwU (HT @MishaAngrist) Wide range of perspectives from DTC
• RT @lukejostins New blog post, in honor of International Women’s Day, on how science can hurt and help the cause http://bit.ly/97eLJm
• RT @dgmacarthur On finding folks you know: 23andMe reveals some unexpected cousins http://bit.ly/dtvrTy
• RT @DNAnetwork: The Pandora’s Box of DNA Identity from The Atlantic http://bit.ly/a6AaM8
• RT @Scitable: Breast Cancer Patients Often Confused by Genomic Testing http://bit.ly/aHaNy6
• Faces of America and Genetic Genealogy Testing from @blaine_5 http://bit.ly/axUdzI
• This is one place where I might like to see Twitter verification… RT @bmahersciwriter: How is it that I’m the first follower of @goBGI !?
• RT @AccessDNA: Myriad Genetics Misrepresents Data Says Yale Genetic Counseling Program: http://bit.ly/dncy3V
• Reason for dropping Helicos from coverage? $HLCS faces “long-term competitive challenges” to technology & “near-term financing challenges”
• $HLCS no longer competitive? Leerink Swann dropping coverage of Helicos Biosciences http://tr.im/QM3R (HT @patsycat21)
• TGen, US Oncology & Life Tech. collaborating to sequence 14 genomes from breast cancer patients: http://bit.ly/9I0IZH (HT @ldtimmerman)
• RT @FierceBiotech: The Pharmaceutical R&D Model is Broken. Here’s How to Fix It. http://is.gd/9Kzr2 (via Xconomy)
• RT @dgmacarthur: Bullshit gene-based diet test gets free advertising via Reuters. News at 11. http://bit.ly/dzTQY6 /via @LIFECorporation
• RT @matthewmarkus Try late 70s, pre-PC: “Personal Genome industry seems analogous to Internet just before the first browser in ‘93″ G Church

Another Tale of the Struggle of Personal Genomics, Full of Sound and Fury, Signifying…What?

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.

As Daniel MacArthur points out at Genetic Future:

…right now there’s a very easy ‘failed industry’ story to write, between deCODE’s demise, 23andMe’s problems, Navigenics’ bungled entry into the Australian insurance market, and so on. And to be honest, I’m finding it pretty hard to blame reporters for writing that story.

MacArthur is absolutely correct that a story about the struggling personal genomics industry is one that seems to quite nearly write itself. But as Avey points out, treating the struggles of any one company as indicative of problems elsewhere, or with the industry as a whole, is a bit “like comparing apples to appaloosas.”

Examining the Evidence. As described above, most of 23andMe’s recent “struggles” are not new developments. In fact, 23andMe has recently received a jolt of positive publicity thanks to the just-concluded PBS series Faces of America. Hosted by Harvard Professor Henry Louis Gates, and featuring celebrities ranging from Stephen Colbert to Mario Batali to Yo-Yo Ma, the final episode focused on genetic genealogy, with 23andMe providing the genetic testing that allowed Gates to probe the genetic heritage of the celebrities and their families, which in turn produced some surprising results. 23andMe is celebrating its recent exposure (Faces of America was also featured on Oprah this week, which I’m told draws a larger viewing audience than PBS or, for that matter, the GLR) by offering $200 off their Ancestry Edition and Complete Edition (which includes both the Ancestry Edition and Health Edition) products.

As for Navigenics, while it’s collaboration with an Australian life insurance company appears to have been a bit of a public relations misstep, I see no obvious connection between that development and the company’s financial affairs. On the contrary, last month Navigenics completed an $18 million Series C financing round in which it added multinational consumer goods giant Proctor & Gamble to its stable of existing venture capital investors.

Then there is deCODE genetics’ well-publicized bankruptcy (and subsequent emergence from bankruptcy), often cited as the strongest piece of evidence to date that personal genomics as an industry simply does not measure up. After all, what could be more damning than the provider of one of the three most prominent consumer genetic testing services filing for bankruptcy protection? Unfortunately, it’s impossible to say what role the success (or lack thereof) of the deCODEme service played in the bankruptcy of deCODE genetics. As I wrote at the time of deCODE’s bankruptcy:

Any bankruptcy filing is a final admission that the current business model is broken, although it’s often very difficult to tell from the outside just which pieces of the business model aren’t working. The deCODEme portion of the business might be operating satisfactorily.

There’s no disputing the financial struggles of deCODE genetics, and there have been hints – including in a recent Newsweek article in which deCODE’s new CEO, Earl “Duke” Collier, informs former CEO Kari Stefansson that if he’s interested in the deCODEme service he had “better buy it now” – that deCODEme may be on its last legs. But without additional information it seems to me unreasonable to conclude that deCODE genetics – a publicly traded company which burned through $676 million over more than a decade, and whose primary focus, unlike 23andMe or Navigenics, was never DTC genetic testing – was undone by the specific failures of deCODEme and the broader inability of the market for personal genomics to live up to its expected potential. As Avey points out, it was never realistic to expect deCODEme to rescue the much larger and long-troubled deCODE genetics.

It is certainly possible that in the not-too-distant future one or more of the existing personal genomics service providers – including 23andMe, Navigenics and/or deCODEme, which, it should be mentioned, do not represent the complete set of personal genomics companies - will disappear from the scene. But after taking a closer look, it’s not at all clear that the narrative of personal genomics as an industry struggling to survive is strongly supported by the publicly available evidence.

An Optical (Dis)Illusion. Why is it, then, that there is such a seeming rush to declare the death – or at least the decline – of the personal genomics industry? MacArthur points out that personal genomics is wending its way through the Garner hype cycle (chart below) and that “right now we’re firmly wedged in the trough of disillusionment, following a peak of inflated expectations for which personal genomics companies themselves must take the bulk of the blame.” 

MacArthur’s assessment is spot on, with one caveat. My strong suspicion is that the Trough of Disillusionment is inhabited largely by those of us – whether academics or professionals, entrepreneurs or investors, early adopters or avid personal genomics observers – who have been watching and contributing to the field of personal genomics for several years (many since its inception in 2007 or thereabouts), and who may have grown weary of anticipating its full-fledged arrival.

But for most of society personal genomics is not yet a mainstream concept. Try stopping ten strangers at a shopping mall and asking them if they have heard of 23andMe. Or Linda Avey. Or, for that matter, George Church or Craig Venter or James Watson. These may be household names in your household, but that is not true of a majority of households. It is only very recently, with the introduction of bona fide celebrities to personal genomics – Stephen Colbert, Eva Longoria and even Oprah discussing genetic ancestry with Skip Gates, or Desmond Tutu and Glenn Close joining the ranks of individuals who have had their whole genomes sequenced and publicly announced – that personal genomics will even begin to make a mark on the broader social consciousness.

Time to Grow Up. Of course, personal genomics aspires to more than a celebrity plaything, and no matter how you view the personal genomics industry today it is easy to see that considerable work remains before a meaningful number of companies begin delivering transformative personalized genomic information and services to large numbers of individuals.

First, the underlying technology must still become less expensive and the underlying science more instructive. Rapid progress in both areas is a promising sign. More importantly, the nascent industry of personal genomics must grow up. This a process that is already underway, with significant segmentation driving the creation of increasingly distinct sub-categories within the field of personal genomics, an industry-wide trend that is not dissimilar from that which is occurring in the genomic sequencing field. (The segmentation of personal genomics will be one topic of conversation at the upcoming GET Conference, and I plan to touch on this in more detail in an upcoming post.)

Over time, the diversification of personal genomics will be a good thing, aiding in the identification of viable business models and separating legitimate businesses from snake-oil salesmen. But it will require time, investment (not all of which will be recouped) and quite probably additional legislative or policy interventions, particularly in the areas of intellectual property and regulatory review that apply to personal genomic services. None of this should come as a surprise, even if the pace of progress is at times slower (to the point of disillusionment) than many of us would prefer.

Looking ahead, I am confident that Avey is correct when she writes that personal genomics will become “such an every day concept that future generations will be amused that we even questioned its viability.” And judging from the abundance of activity and advancement in the field as a whole, as well as the dozens of entrepreneurs and investors that have contacted me in recent months to discuss their plans for starting or growing personal genomics businesses, I think it will hardly take a generation before personal genomics moves mainstream.

(Images courtesy of the Wikimedia Commons: Don’t Panic, Garner)

• 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)
• Last tweet re: @CompleteGenomic – it is that kind of number that makes #GET2010 so historic. By 2011, individuals with WGS in the 1,000s
• Still catching up, including re: AGBT, but this impresses me: @CompleteGenomic announces 500 genomes in the pipeline: http://bit.ly/abhWNi
• Are Sperm Donors Really Anonymous Anymore? http://bit.ly/c9KzOP (Slate, 3/1) The myth of genetic anonymity is increasingly exposed as such.
• Eric Lander on the disconnect between science and economics: http://bit.ly/aRG7rU “Health care is ‘rife with market failures’” (WSJ, 2/22)
• At AAAS meeting, personal genomic sequencing likened to “publishing a book that cannot be read.” http://bit.ly/91c5Nu (GenomeWeb, 2/23)
• Sage Bionetworks to be NCI Center http://bit.ly/dCLKrK (@GenomeWeb_News, 2/23)
• FDA’s IVDMIA Guidance Just as ‘Imminent’ today as it was in 2007 http://bit.ly/9ua7Pd (The Sample, 2/25)
• Post-DNA Direct acquistion, MedCo plans to move genetic testing from payor-by-payor decision to standard of care http://bit.ly/aMpFfy (2/25)
• Your Genome In the Cloud: GenomeQuest Wants to be the Google of DNA Data Searches: http://bit.ly/cLAiC1 (2/25 v @Ryan_McBride)
• NHGRI Launches Genomic Education Resource http://bit.ly/aOE9ao (Please bear with me as I move into some news from last week, and before.)
• New to Personalized Medicine? MIT’s Technology Review has a great set of introductory articles: http://bit.ly/9Wq4Sb (HT @emilysinger)
• Crowdsourcing pharma whistleblowing: http://bit.ly/bxXMAU For those of you with an abundance of free time.
• FDA Commish Hamburg: “We have allowed the arm of regulatory science to become weak and underdeveloped” http://bit.ly/9SmpZT Agreed.
• If you haven’t heard, @MishaAngrist is now on Twitter. If you aren’t following him, you should. #FollowThursday
• RT @markgfh: My latest Science Matters column for Eureka: http://bit.ly/br2l59 On growing demand for embryo screening
• After GINA, Where Do Life Insurance Firms Stand on Using Genomic Information for Coverage Decisions? http://bit.ly/dArv8A
• Nice profile of Geospiza from @ldtimmerman: whole-genomes, from sequencing to software: http://bit.ly/aza7EC
• Catching up on AGBT thanks to MassGenomics (IonTorrent and ipods: http://bit.ly/9CzfWD) and @dgmacarthur http://bit.ly/b2BB2Z
• X-Prize Ventures Further Into Biology: New Organs from Stem Cells and New Doctors from Software http://bit.ly/9bPuHl (@crossborderbio)
• Struggling to slog through the “trough of disillusionment”? @dgmacarthur on @23andMe and personal genomics http://bit.ly/9JcxWc
• Myriad Assures Investors of Strong Patent Position Despite ACLU Anti-Gene Patenting Lawsuit http://bit.ly/a0fQ92
• Who drives adoption of EHRs: patients, docs or hospitals? MSFT HealthVault leaning toward hospitals: http://bit.ly/aTijaZ
• MSFT Builds Out Health IT Portfolio, Waits (and Waits) for Market to Materialize http://bit.ly/d9hU8m (v @ldtimmerman)
• RT @dgmacarthur: Warning from @lindaavey (@23andMe co-founder) of impending NY Times attack piece on personal genomics: http://bit.ly/cdtxMG
• I agree with @GeneSherpas: @23andMe and the personal genomics industry as a whole is morphing, not dying.
• RT @dgmacarthur: China’s BGI is “on track to surpass the entire sequencing output of the US”: http://bit.ly/a9YrxD /via @d_swan
• Shades of 1993: GET Conference to Search for the Killer App in Personal Genetics: http://bit.ly/9NFXhu #GET2010
• RT @nanopore: Inside You,150 x more ‘Not You Genes’ than ‘You Genes.’ “Our Other Genome” in Nature http://bit.ly/aDTkCH
• RT @dgmacarthur: Genetic genealogist @blaine_5 reviews his Pathway Genomics ancestry results: http://tinyurl.com/yffj7gk
• BioReference moving into prenatal genetic testing space, buys regional genetics lab (via The Sample): http://bit.ly/dnmSKr
• Francis Collins is on the Diane Rehm show at 11a today to discuss the future of personalized medicine: http://bit.ly/jZer
• Redefining privacy in the era of personal genomics http://bit.ly/almOFR Ars Technica on the difficulty of DNA de-identification
• From Bench to Market: The Benefits and Limits of Non-Disclosure Agreements: http://bit.ly/bB5o15
• RT @humangenomeorg Drinking from the Firehose of Genomic Data: Supercomputing & Genomics http://bit.ly/cDI3a2
• The Texas Newborn Blood Spot Saga Continues http://bit.ly/cIpgwJ
• A Drug Trial Cycle: Recovery, Relapse, Reinvention (by Amy Harmon, NYT): http://nyti.ms/bqxULA
• Genome Boy (aka Misha Angrist) interviewed re: upcoming personal genomics book: http://bit.ly/9UyL4i
• Advice for entrepreneurs: Protect yourself with patents and be prepared to fight: http://bit.ly/8ZoCQX

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.

These agreements, however, are binding only on the parties who actually execute them. Certain venture capitalists and strategic investors may resist signing non-disclosure agreements as a policy matter or for fear that they may interfere with alternative projects or in-house development activities. Thus, entrepreneurs may need to develop “teasers” that provide basic background information on their product or process without disclosing sensitive proprietary information so that potential investors and licensees understand the benefits and burdens associated with executing a non-disclosure agreement.

To be effective, a non-disclosure agreement must identify the appropriate investor or licensee legal entities that are intended to be bound by the agreement. Those investor or licensee parties should also be responsible for breaches of the agreement by their affiliates and by any accountants, attorneys or other representatives to whom they provide information. Some non-disclosure agreements go one step further and require signers to obtain a separate non-disclosure agreement in favor of the entrepreneur from any affiliate or representative who is provided confidential information.

Non-disclosure agreements should carefully define the confidential or proprietary information subject to the agreement. If there are exceptions to the prohibitions on disclosure or use, they should be precisely and narrowly defined. Common exceptions include (1) information generally available to the public through no breach of the non-disclosure agreement, (2) information that was known by the recipient prior to disclosure by the entrepreneur, (3) information obtained by the recipient from a third party who is not bound by a confidentiality agreement or other obligation of confidentiality, and (4) information independently developed by the recipient. Exceptions (2) and (4) are subject to potential abuse by recipients; many confidentiality agreements eliminate exception (4) altogether and require that the recipient provide written evidence demonstrating the existence of prior knowledge to satisfy exception (2).

Although the main point of a non-disclosure agreement is to prohibit improper use and disclosure of the information, that prohibition is not in fact total. For example, the recipient considering an investment will “use” the proprietary information in assessing the potential investment, and so the agreement should not prohibit that use. Where an entrepreneur seeks assistance in commercializing a product or process, the use restrictions must be carefully balanced to permit necessary commercialization activities without allowing the entrepreneur’s know-how and proprietary information to become part of the public domain. Simply describing a permitted use as “commercialization” is overbroad and subject to abuse. The parties must think through the commercialization process carefully to define the circumstances under which proprietary information can be disclosed to others.

The entrepreneur also needs to think about what happens after the recipient has evaluated the confidential information provided. Agreements should permit the entrepreneur to require the return or destruction of proprietary information in a recipient’s possession at the entrepreneur’s request. But the return or destruction of documents may not be enough, since the recipient of the information still knows it. To cover that issue, the agreement should require recipients to maintain the confidentiality of such information for a lengthy or indefinite term.

What happens if the recipient violates the prohibitions in the agreement and, for example, discloses the information to another party? The usual legal remedy for breach of an agreement is to sue for money damages. But in a case such as this, it could be impossible to determine what the damages are—how can one value the potential value of proprietary information that could be a bonanza or could be a bust? The alternative is to provide an acknowledgment by the parties that breaches of the agreement cannot be cured by monetary damages alone, and that equitable remedies such as temporary restraining orders and injunctions are appropriate to restrain breaches. Then, if the recipient is breaching the agreement, the inventor can go into court and obtain a court order that will stop the recipient in his tracks. Some people may violate their agreements, but they will think long and hard before violating an order from a court.

Entrepreneurs should also consider whether to include a covenant that prohibits solicitation of employees, sometimes called a “no-poaching covenant.” Potential investors who gain access to start-up businesses may decide to pass on an investment but to offer employment to talented employees with whom they interact during due diligence. A tailored employee non-solicitation provision will protect the entrepreneur from employee raiding.

Confidentiality agreements are generally a precursor to more definitive investment or licensing agreements entered into after due diligence has been completed and a plan for commercialization has been developed. Entrepreneurs generally seek to include in these preliminary agreements language that disclaims any representations and warranties with respect to the proprietary information to be disclosed during due diligence. Such representations are warranties are more appropriate in the context of definitive agreements when the business arrangements and related representations and indemnities can be spelled out in detail.

While well-crafted non-disclosure agreements provide entrepreneurs with legal and equitable remedies for improper disclosure or use of proprietary information, the agreements alone may not be effective to stop “bad actors” from potentially harmful disclosures. Therefore, entrepreneurs need to undertake their own diligence about potential recipients of proprietary information to confirm that such persons are professional and respected participants in the marketplace.

Contributed by 

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.

Worse than the discovery of the mtDNA project, in further allegations reminiscent of “climategate,” the Tribune claimed that the communications evidence demonstrates an effort by DSHS “to limit the public’s knowledge of aspects of the newborn blood program, and to manage the debate around it.” According to the Tribune, the e-mails demonstrate that “in 2003, when the agency started to release blood spots for outside research, officials knew they had a parental consent issue on their hands—but tried to avoid it.” For example, the Tribune’s web site reproduces an e-mail from a researcher arguing against a press release describing the research (pdf): “This makes me nervous. Genetic privacy is a big ethical issue & even though IRB approval is required for use of the spots in most situations and great care is taken to protect the identity of the spots, a press release would most likely only generate negative publicity.” 

Public perception of science could sustain further damage from the exposure of scientists or their advocates trying to keep quiet about what they were doing because they thought the public would not approve. In response to the new information, Harrington has alleged bad faith on the part of DSHS during the earlier settlement negotiations. He threatened a follow-up lawsuit over the military research use, based on DSHS denials during the negotiations of any “law enforcement” access to the samples.³

It is unclear what relief plaintiffs would be seeking in a new suit. DSHS is already required to destroy the samples and has stated that it will not ask researchers to return samples already released for research. The researchers are obligated to destroy the samples when their studies are completed. Still, these developments serve as yet another reminder that scientists and supporting policy makers need to do a better job of maintaining honest and open dialogue with the public about their research activities.

_______________________________

          ¹ State Sunshine Laws: The Public Information Act of Texas is a series of laws designed to guarantee that the public has access to public records of government bodies at all levels in the state. Texas Government Code, Chapter 552, was enacted in 1993 and has been amended several times since. It gives citizens the right to access records at various levels of Texas government, without a requirement to declare the purpose for reviewing those records.

          ² Human mtDNA is a small circular molecule – only approximately 16.5 thousand bases of sequence as compared to millions of bases of sequence in each of the linear nuclear chromosomes. Much of the mtDNA sequence is identical for all humans, but there are two short hypervariable regions that may be used to identify ancestral origins, as noted by DSHS spokeswoman Carrie Williams. The inheritance of mtDNA is maternal, and in the 1990s a team of British scientists famously exploited this property, along with the strict paternal inheritance of the Y chromosome, to discover a very high probability that Thomas Jefferson fathered at least one of the children of his slave, Sally Hemings. Nature. 1998 Nov 5;396(6706):27-8. Jefferson fathered slave’s last child.

          ³ Reasonable people might disagree about whether the stated goal of identifying human remains constitutes a “law enforcement” purpose. DSHS spokeswoman Carrie Williams explained, “Our understanding of mtDNA is that it’s not used to pinpoint exactly who a person is, but can help determine origins.” She also contended that their “intentions were good ones,” and pointed out in another report that the project has been listed on the DSHS website for weeks.

• RT @fredcobio: LavaAmp in @WIRED The First and Last Meeting of Everyone with a Fully Sequenced Genome http://is.gd/8EsGw #GET2010
• Remote participation will be happening. Stay tuned. RE: @blaine_5 Announcing the GET Conference 2010 #GET2010 – http://tinyurl.com/yefu7yy
• Personal Genomics in the News: Desmond Tutu and the GET Conference: http://bit.ly/aFTuXA #GET2010
• Have a problem employee? Bench to Market has some advice for you: http://bit.ly/aqUqn8
• “Quintiles’ new era–‘Having skin in the game’ for drug development” http://bit.ly/bppQyN CROs coming closer to pure pharma.
• GLR Update: Australia Tackles Disclosure of Genetic Information without Consent: http://bit.ly/aCrsoh
• Is deCODEme part of @decodegenetics’ future? Says new CEO Collier: “If you want one, you’d better buy it now” http://bit.ly/cdcdqp
• RT @ldtimmerman: Cambridge, MA-based Helicos president resigns, according to Friday evening 8-k. http://bit.ly/9G3jD5
• RT @blaine_5: Future of decodeme tests not very bright? Newsweek: deCODE, A Biotech Star Gone Bust – http://www.newsweek.com/id/233494
• New VC name to know: “Longwood Founders Fund” RT @ldtimmerman: Sirtris founders start new Boston VC fund. http://bit.ly/bECBVJ
• Recap from @chiah on Bay Area Personalized Genomics panel: http://bit.ly/cQSjTh Watch the conversation or review the tweets at #genome
• Misha Angrist talks about his 100,000 new SNPs, a Q&A with Lauren Dame re: GINA and more: http://bit.ly/b2BD2V (via @DukeIGSP)
• Exome Sequencing as a powerful (but transitional) tool for identifying genetic causes of disease: http://bit.ly/cLcDdW (via @BioInfo)
• Last tweet: “This movement will be driven by a focus on outcomes, which pharma companies are more and more having to commit themselves to.”
• Pharma using tech to see beyond drugs alone: RT @cwhogg, @ahier Meds not working? There’s an app for that http://bit.ly/a8vAsu
• RT @DukeIGSP: Arizona scientists devise “first, versatile DNA reader” capable of detecting each of DNA’s 4 bases. http://bit.ly/cH3zGV
• On the importance of really working to achieve informed consent: RT @shwu: Henrietta Lacks and Invisible People http://ff.im/-fO2qA
• New Hampshire considering bill that would ban use of biometric data in identification cards: http://bit.ly/a3yHab

Hot on the heels of the Nature paper (which has been exceptionally well-covered elsewhere, including  by Not Exactly Rocket Science, the Technology Review, and the New York Times) comes this morning’s announcement that many of those same genomics pioneers, including Watson, Church, Gates, Quake and others, will be sharing the stage together at the inaugural GET (Genomes Environments Traits) Conference. From the conference announcement:

“The GET Conference 2010 marks the last opportunity in history to gather a majority of individuals in the world with public personal genome sequences in a single venue,” says George Church, founder and principal investigator of the Personal Genome Project and professor of genetics at Harvard Medical School. “With rapid advances in technology, the number of individuals with personal genome sequences is expected to rise dramatically, from dozens today to thousands by 2011 and a million or more individuals within the next few years.”

The morning portion of GET Conference 2010 will feature wide-ranging discussions during which personal genome pioneers and globally recognized leaders of genomic science and industry, including Misha Angrist, George Church, Jay Flatley, Henry Louis Gates, Jr., Rosalynn Gill, Seong-Jin Kim, Greg Lucier, James Lupski, Stephen Quake, Dan Stoicescu and James Watson, will share their experiences and discuss the future of personal genomics. Award-winning science journalists Carl Zimmer and Robert Krulwich will moderate the discussions.

Even with the additions of Tutu and !Gubi to the whole-genome sequence society, the individuals who will share the stage at the GET Conference are not representative of the full breadth of human diversity, genetic or otherwise. But both the conference and the addition of two new whole genomes from southern African strongly suggest this  is changing. As George Church notes today in WIRED, genomic technologies are poised to “…spread even faster than the rise of computers from obscurity in 1980 to access for everyone today, even in developing nations,” and he is far from alone in believing that, within a few years, not even the largest sports stadiums will be able to hold all those who have had their personal genomes sequenced.

That global vision for personal genomics is part of the mission of PersonalGenomes.org, a 501(c)(3) charitable organization developed to support the Personal Genome Project and to serve as both a pioneer and ambassador of emerging technologies and knowledge that will positively impact the health and well-being of humankind worldwide. I’m pleased to be a part of that effort, both as a member of the GET Conference Steering Committee and as a part of a law firm, Robinson, Bradshaw & Hinson, that is sponsoring the GET Conference and has served as counsel for PersonalGenomes.org since its inception.

You can find out more, as well as register for the conference, at the GET Conference website.

Fresh from a top biochemistry Ph.D. program, Beth was your fifth employee. Her technical expertise and ability to charm investors, lenders and prospective customers made her the obvious choice when, as the company burgeoned, you decided to formalize a roster of senior officers. As Executive Vice President for Biotechnology, Beth has since had a hand in every aspect of company business and operations.

Over the last year or so, however, Beth has moved from core asset to affirmative liability. She has missed critical internal and client meetings, and may go days without responding to calls or e-mails. According to her direct reports, she’s become largely invisible to them as well. You have no hint of what may be behind the situation.

And what about her behavior when she is in the office? Colleagues report phone calls hastily concluded and the laptop shifted or shut whenever they appear. Has some personal vice taken over? Is she shopping herself to competitors, or even planning her own competing startup?

Convinced you’ve met every expectation that fairness and friendship impose, and tumbling rapidly from anxiety to paranoia about the risks the situation poses to the company, you’ve spent a sleepless weekend pondering your options. It’s now inescapable: Beth has to go, now.

Can you terminate the problem employee? Terminating anyone, and particularly a key senior employee, can be a minefield. Rather than attempting first to track down Beth, you call Angie, your outside employment counsel. Angie has a checklist of issues, and the two of you need to work it through. Angie first establishes that Beth is based at your company’s North Carolina headquarters. She reminds you that employment law varies widely from state to state, and that the answers to the issues may vary dramatically if Beth were resident in your California, New Jersey or Florida offices.

You first confirm your prerogative to fire Beth under these circumstances. In North Carolina, the default rule is that, absent an employer-employee contract (which could be created by a personnel handbook—as discussed below) or collective bargaining agreement, employment is “at will.” This means that either party may terminate the employment at any time and for any lawful reason. Many employment contracts restrict the rights to terminate and require notice or other procedural steps the employer must take before it can terminate (e.g. board of directors’ approval).

Happily for you at this stage of the analysis—though less so later— Beth has no contract, and there are no union issues.

Angie reminds you that your company’s personnel handbook addresses discipline and termination. Reviewing it, you see that it outlines a three-step disciplinary procedure for performance-related deficiencies: an initial notice to be given orally; a second notice to be given in writing and placed in the employee’s file; and termination as a third and final step if the deficiencies persist. You are relieved when Angie reminds you that the company has, in the provision itself, effectively reserved the right to deviate from the three-step procedure as it deems appropriate. Angie also points out that the title page of the handbook proclaims in boldfaced, capitalized type that nothing in the handbook creates any form of employment contract or disturbs the “at will” relationship.

Angie next works through with you the terms and covenants in the agreements between your company and its various investors. These sometimes impose or imply restrictions on the company’s ability to terminate key personnel. Satisfied that terminating Beth will not offend any lender or investor, and that your board of directors need not be consulted in advance of the decision (although you are already sweating over the questions you know you’ll face from the board in its aftermath), Angie and you shift the analysis from “can you terminate Beth” to “how to terminate Beth.”

How to terminate the problem employee. Angie’s first recommendation is that you communicate the termination decision to Beth as fast as reasonably possible. If Beth suspects she is about to be terminated, Angie explains, she may pre-emptively complain that her performance problems are the consequences of, for example, physical or mental ailments or job-related harassment. Such a complaint creates a risk that termination—even though the employer had settled on it before learning of the complaint—will provoke claims of discrimination and retaliation under state and federal anti-discrimination laws.

Angie next observes that Beth’s inaccessibility raises some practical concerns. Ordinarily, termination occurs in a face-to-face meeting, allowing the employer both to announce the decision and to review attendant issues. With Beth’s availability for such a meeting uncertain, Angie suggests that you and she devote the next few hours to preparing a written termination package. The package will include:

A short letter notifying Beth of her immediate termination.

Angie stresses the need, in the letter and in all other communications with Beth on the subject, to be clear, consistent and truthful. She explains that you owe Beth no detail about the company’s reasons for terminating her— a simple statement to the effect that “we have concluded the decision is necessary under the circumstances” is sufficient—but any attempt to explain the decision, including in response to questions from Beth, must be accurate. Yielding to the impulse to soften the message by, for example, characterizing the termination as the result of “elimination of the position,” or assuring Beth that her performance was no factor in the company’s thinking, invites litigation when, as it inevitably will, some version of the truth makes its way to Beth.

The letter will require Beth to immediately turn over her laptop, Blackberry, any physical files, and any electronic storage media containing company information. The letter also directs Beth to sign and return a copy of the letter with these items, and by doing so affirm that she possesses no company information (other than, of course, what is in her head—see below) and has not, at any time, disclosed or used company information other than as authorized by the company.

Noting your raised eyebrow, Angie answers the question before you ask: no, none of these measures can ensure that Beth retains no proprietary information. She goes on to explain that the only way to provide a reasonable measure of confidence that Beth will not use proprietary information to the company’s disadvantage is:

A proposed severance agreement offering Beth significant severance benefits in exchange for signing a noncompetition, nondisclosure and nonsolicitation agreement.

With no contract in place with Beth, she is as free to begin work for your competitor following her termination as you are to fire her, a prospect that freezes your blood. Angie explains that, while there are some constraints on Beth’s ability to use your proprietary information for the benefit of a competitor, including Beth’s own startup should she go that route, your best protection by far is a comprehensive agreement keeping her out of the market for a period of time (the noncompetition feature) and prohibiting her from soliciting other employees to join her elsewhere or from using company information elsewhere.

You note that Beth must still provide any new employer with a written summary of the nonsolicitation and nondisclosure provisions (the required summary is to be part of the agreement) even after the noncompetition period expires. Angie explains that this requirement will tend to enlist new employers in the cause of enforcing these provisions; North Carolina law, like that of many states, could permit your company to sue a competitor that ignores violations.

The agreement will also contain a release of any legal claims against the company, and will liquidate Beth’s rights as a shareholder of your private company.

To obtain such an agreement now, however, you will have to buy it in exchange for whatever combination of cash and non-cash consideration (e.g. post-termination health benefits) proves sufficient to persuade Beth to accept the restrictions. Recognizing glumly that Beth holds most of the cards in this negotiation, you also make a mental note never again to extend an offer of hire or promotion to any key position except on condition that the candidate sign one of these agreements before he or she can assume the role.

Once these documents are in shape, Angie will have them both couriered to Beth’s home and sent there by overnight mail (Beth lives only five miles from the office, but Angie observes that overnight mail transmission will create a paper trail establishing by inference when the company finally settled on termination). She also instructs you to have your IT department immediately cut off Beth’s access to company systems, as well as her Blackberry service. You are to instruct your administrative head that, if Beth shows up at the office, she is to be escorted to a conference room, instructed to wait until you arrive, and watched to ensure she does not access company systems (by, for example, using someone else’s terminal) or records.

Angie suggests that Beth will very likely insist on meeting with you. This meeting should include Angie, with Beth invited to include her own legal counsel. She also cautions you that you may be in for a long legal battle to restrict her from capitalizing on what you view to be proprietary company information unless you can convince Beth to sign the severance agreement.

Now comfortable that you’ve developed a comprehensive plan of action, you begin to make the necessary calls within the company as Angie begins drafting the termination letter and severance agreement. It will be a long time before you’ve fully processed your personal reaction to this difficult situation, but you’re now able to begin to trade exhausting worries over what to do about Beth for constructive thinking about what to do after Beth.

Since that time, Australia’s National Health and Medical Research Council (NHMRC) has tackled the same issue, publishing new privacy guidelines for health practitioners on the disclosure of genetic information (pdf).

In each case, the basic thrust of the guidance for medical practitioners is the same – there are certain circumstances where a patient’s genetic information may be disclosed against his or her wishes. However, the guidance from the GMC and the NHMRC does differ in several important respects.

First, while the GMC’s guidance applies to all doctors in the United Kingdom, the NHMRC’s guidance is restricted to Australian doctors in private practice. The NHMRC’s guidance also restricts its applicability to the disclosure of genetic information to living genetic relatives for medical purposes. Disclosures relating to unborn children (e.g., information related to embryos or carrier status), to legal but non-genetic relatives (e.g., adopted children or spouses) or for genetic research are all outside of the scope of the NHMRC’s guidelines. The GMC’s guidelines, on the other hand, contain no such specific limitations, referring only to the practitioner’s responsibility to balance the patient’s interests against those of others, and to disclose genetic or other information when justified in the public interest.

It is that “public interest” standard for disclosure that most clearly distinguishes the GMC’s guidance from the NHMRC’s. The NHMRC’s guidance is quite specific:

Use or disclosure of genetic information without consent may proceed only when the authorising medical practitioner has a reasonable belief that this is necessary to lessen or prevent a serious threat to the life, health or safety of a genetic relative.

(emphasis in original)

Dozens of pages of supplemental guidance help practitioners determine when this standard is satisfied and how to manage involuntary disclosure in the event that it should become necessary.

The GMC’s guidance, on the other hand, is far broader in its application and less detailed in its discussion. The discussion of “genetic and other shared information” is confined to a single page and disclosure is permissible whenever it is “justified in the public interest.” The “public interest” standard, in turn, encompasses much more than the prevention of series threats to genetic relatives, including (i) the prevention of communicable diseases or serious crimes, (ii) the furtherance of medical research and (iii) “education or other secondary uses of information that will benefit society over time.”

Narrower and more fully articulated than the GMC’s guidance, the NHMRC’s guidance arguably strikes a better balance between the harms produced by the unconsented disclosure of a patient’s genetic information and the benefits of that information for the patient’s genetic relatives. Whatever you think of the NHMRC’s guidance, however, permitting doctors to disclose genetic information against their patients’ wishes calls forth many of the same questions raised in Emily Sherlock’s original GLR piece.

In certain circumstances, genetic information possesses indisputable value to a patient’s genetic relatives, as well as individuals that are known to the patient but are not genetically related, including non-genetic family members or caregivers. Its disclosure may even operate to further the nebulous “public interest” referred to in the GMC’s guidance. As genetic information occupies an increasingly central role in our medical care and in our lives, policymakers and legislators worldwide must continue to carefully weigh the benefits of compelled disclosure against competing considerations, including, (i) the importance of patient autonomy, (ii) the genetic relatives’ right not to know certain information, (iii) the potential that individuals will forego valuable genetic testing if they fear their genetic privacy will not be respected and (iv) the difficulty of mitigating risks associated with the disclosure of genetic information.

• RT @jensmccabe: pharma + academia: cross-pollination between Lilly and Harvard? Interesting – http://tinyurl.com/yaecory
• RT @crossborderbio: @matthewherper ’s call for SPA transparency: http://bit.ly/as7O7K My take: http://bit.ly/aCqJ0T
• Improving complex disease risk production w/ phenotypic & genotypic info from close relatives: http://bit.ly/dvb0Od (Genome Medicine)
• Last tweet: “I want to build a $10 sequencer that can sequence the genome, and do it for maybe $10. That’s what we need. That’s biology.”
• RT @bioitworld: Exclusive: Kevin speaks with Ron Davis about a 3rd gen sequencing platform from Ion Torrent: http://bit.ly/dnO8sn
• “Personal Genomics: What Consumers and Investors Want to Know” panel last night http://bit.ly/chnLvh Great coverage from @chiah #genome
• RT @Ryan_McBride: Guess who’s at Third Rock Ventures, launching a new biotech? Hint: He used to work at CombinatoRx http://bit.ly/acncMV
• Personal Genomic Company Testing Comparisons from @AccessDNA http://bit.ly/aSubjP Good side-by-side comparisons of DTC providers
• RT @blaine_5, @megansmolenyak: 3 mos of prime time genealogy starting tonight! Check out Faces of America http://bit.ly/5darCx
• Feel guilty sitting @ desk & watching RT @tgoetz: The argument for better health in 3:53 (#thedecisiontree video) http://bit.ly/cW0hHi
• Does anybody care about HIPAA anymore? http://bit.ly/bPeN5V Lax enforcement, delays reducing concerns?
• A look at the business model behind @patientslikeme from @Ryan_McBride of Xconomy: http://bit.ly/aLfwwL
• RT @techreview: Genetic Testing Heads to the Pharmacy: Several recent deals could make tests more common. http://bit.ly/cFAKgV
• The HER2 Testing Conundrum: http://bit.ly/artmYr (via @NatureNews)
• Phone-based genetic counseling vs standard counseling in women at risk of BRCA1/2 mutation http://bit.ly/7R2ixE (RT @AccessDNA, @dctrials)
• Agendia receives clinical laboratory permit from NY; can now offer MammaPrint in New York: http://bit.ly/aD0MDE (via @GenomeWeb_News)
• RT @DukeIGSP: DNA sequencing to be outsourced to China? @scienceprogress says yes. http://bit.ly/djmnrU
• RT @DNAnetwork: RT @PHGFoundation: Pre-conceptual genetic testing for multiple conditions http://bit.ly/bTm2vO
• RT @tgoetz wowzers! very cool combo of words & graphix RT @pioneerrwjf: The Coming Revolution in Health Care http://bit.ly/cTlo7V
• Is a follow-on biologics pathway dead? BIO chief shows @FierceBiotech a (small) window of opportunity http://bit.ly/dyuO8t (@crossborderbio)
• RT @phylogenomics: When will scientists learn? Informed consent is key to trust: Debate Over Blood From Newborn Tests http://nyti.ms/bEBHRg
• SACGHS Gene Patent Recommendations Still Controversial: http://bit.ly/bC1Z8s (feat. bonus Schoolhouse Rock! Youtube clip)
• NH considering (again) patient privacy bill that would expand patient notification/consent requirements under HIPAA: http://bit.ly/caRkpM
• RT @mobilehealth: 1/5 Epocrates users want an iPad-not 20% of all MDs, but those already using Epocrates http://tinyurl.com/yjhq7fk
• Recap – and criticism – of the snow-shortened SACGHS approval of gene patent recommendations on Fri: http://bit.ly/bfqYF8
• FDA Updates Label for Warfarin to Include genetic variants as one factor (among several) for dosing recommendations: http://bit.ly/dvnPPf
• RT @HFDigest: RT: @ADAM_Health FCC’s Broadband Plan Looks to Mobile Phones for Health Care – http://ow.ly/14lPS
• RT @ScienceInsider: Landmark Pluripotent Patent Has Stem Cell Researchers Nervous http://bit.ly/aGY36G
• RT @DukeIGSP: RT @ahier: Research on the Mexican genome could broaden scope of personalized medicine http://bit.ly/bZKU8h
• RT @matthewherper: Medicine is a fight with broken biology, and biology usually wins.