The Faculty Lounge

Online Symposium on the Law, Ethics & Science of Re-identification Demonstrations

Over the course of the last fifteen or so years, the belief that “de-identification” of personally identifiable information preserves the anonymity of those individuals has been repeatedly called up short by scholars and journalists. It would be difficult to overstate the importance, for privacy law and policy, of the early work of “re-identification scholars,” as I’ll call them. In the mid-1990s, the Massachusetts Group Insurance Commission (GIC) released data on individual hospital visits by state employees in order to aid important research. As Massachusetts Governor Bill Weld assured employees, their data had been “anonymized,” with all obvious identifiers, such as name, address, and Social Security number, removed. But Latanya Sweeney, then an MIT graduate student, wasn’t buying it. When, in 1996, Weld collapsed at a local event and was admitted to the hospital, she set out to show that she could re-identify his GIC entry. For twenty dollars, she purchased the full roll of Cambridge voter-registration records, and by linking the two data sets, which individually were innocuous enough, she was able to re-identify his GIC entry. As privacy law scholar Paul Ohm put it, “In a theatrical flourish, Dr. Sweeney sent the Governor’s health records (which included diagnoses and prescriptions) to his office.”

Sweeney's demonstration led to important changes in privacy law, especially under HIPAA. But that demonstration was just the beginning. In 2006, the New York Times was able to re-identify one individual (and only one individual)  in a publicly available research dataset of the three-month AOL search history of over 600,000 users. The Times demonstration led to a class-action lawsuit (which settled out of court), an FTC complaint, and soul-searching in Congress. That same year, Netflix began a three-year contest, offering a $1 million prize to whomever could most improve the algorithm by which the company predicts how much a particular user will enjoy a particular movie. To enable the contest, Netflix made publicly available a dataset of the movie ratings of 500,000 of its customers, whose names it replaced with numerical identifiers. In a 2008 paper, Arvind Narayanan, then a graduate student at UT-Austin, along with his advisor, showed that by linking the “anonymized” Netflix prize dataset to the Internet Movie Database (IMDb), in which viewers review movies, often under their own names, many Netflix users could be re-identified, revealing information that was suggestive of their political preferences and other potentially sensitive information. (Remarkably, notwithstanding the re-identification demonstration, after awarding the prize in 2009 to a team from AT&T, in 2010, Netflix announced plans for a second contest, which it cancelled only after tussling with a class-action lawsuit (again, settled out of court) and the FTC.) Earlier this year, Yaniv Erlich and colleagues, using a novel technique involving surnames and the Y chromosome, re-identified five men who had participated in the 1000 Genomes Project — an international consortium to place, in an open online database, the sequenced genomes of (as it turns out, 2500) “unidentified” people — who had also participated in a study of Mormon families in Utah.

Most recently, Sweeney and colleagues re-identified participants in Harvard’s Personal Genome Project (PGP), who are warned of this risk, using the same technique she used to re-identify Weld in 1997. As a scholar of research ethics and regulation — and also a PGP participant — this latest demonstration piqued my interest. Although much has been said about the appropriate legal and policy responses to these demonstrations (my own thoughts are here), there has been very little discussion about the legal and ethical aspects of the demonstrations themselves. As a modest step in filling that gap, I’m pleased to announce an online symposium, to take place the week of May 20^th, that will address both the scientific and policy value of these demonstrations and the legal and ethical issues they raise. I’ll cross-post my own contribution here, but the full symposium will be hosted over at Bill of Health. Participants fill diverse stakeholder roles (data holder, data provider — i.e., research participant, re-identification researcher, privacy scholar, research ethicist) and will, I expect, have a range of perspectives on these questions:

Misha Angrist

Madeleine Ball

Daniel Barth-Jones

Yaniv Erlich

Beau Gunderson

Stephen Wilson

Michelle Meyer

Arvind Narayanan

Paul Ohm

Latanya Sweeney

Jennifer Wagner

I hope readers will join us on May 20.

The Return of Jonah Lehrer, Apparently

So last night, the Twitterverse discovered, seemingly by accident, that today at noon, Jonah Lehrer will make his first public appearance since his spectacular fall from grace after admitting not only to self-plagiarism but also to borrowing from other writers (including his friend Malcolm Gladwell) without attribution and fabricating interviews and sources. His appearance will come in the form of a keynote address at the Media Learning Seminar 2013, sponsored by the Knight Foundation. The organizers of the event report that Lehrer will give a typically Lehreresque talk on the neuroscience of decisionmaking, including the decisions that led him to defraud his readers. In case you aren't in Miami, it's your lucky day: the event, including Lehrer's talk, is being livestreamed here.

As some have pointed out (see the comments, too), this was a pretty soft launch for what organizers are only now saying, after Twitter and its many angry fellow science writers discovered Lehrer's scheduled appearance, will include a mea culpa from Lehrer. The fact that the conference bio of Lehrer makes no mention of his misdeeds, including the fact that the publisher of his most recent book, Imagine, took the unusual step of recalling all copies of the book, does not inspire confidence that either the Knight Foundation or Lehrer initially intended this to be a thoughtful, appropriately contrite reflection on what happened. Lehrer's former colleague, collaborator and friend, the science writer David Dobbs, for one, is pretty angry. He says that he and others he knows are owed, but have not received, apologies from Lehrer, and he has pressed the conference organizers to put a few questions to Lehrer today.

As for Lehrer's anticipated discussion of the neuroscience of plagiarism and fabrication, I confess that my expectations are low. I've always thought that by far Lehrer's biggest sin was not his self-plagiarism, his more traditional plagiarism of others' work, or even his fabrication of Dylan quotes. Reusing text from his blog in a New Yorker post is between Lehrer, his God, and the various people who paid him for unique content, but I can't get very worked up about it on behalf of his readers. And as for his "old fashioned" plagiarism, that is, of course, a serious misdeed, but Gladwell readily forgave his friend, and Dylan, not surprisingly, doesn't seem to care.

As a serious consumer of social science and one interested in how it is produced and communicated, for me, Lehrer's biggest sin will always be the poetic license he took with science in the name of crafting a sexy and sellable just-so story. (Lehrer's fellow science writers who were denied the opportunities Lehrer has been given, in part because they insisted on engaging in careful and responsible — but less sexy — science communication are also victims of this sin.) You can read more about that here. (Disclosure: Lehrer's interlocutor in this exchange, and in an earlier New York Times book review of Imagine, is my husband. I also watched with some irritation as Lehrer came close, as the scandal unfolded, to blocking publication of their interview. Discount accordingly.) 

Update: The archived video of Lehrer's talk is here (the conference organizer begins moving in the direction of an introduction to Lehrer at around the 1:00:30 mark, and Lehrer himself starts at around the 1:03:30 mark). As others have remarked, the paralells to Lance Armstrong's mea-culpa-cum-comeback are hard to miss. Also of note: the giant screen behind Lehrer scrolling live tweets, most of them critical of him. No doubt the $20,000 Lehrer was paid for the talk helped ease the pain.

Update 2: Image above is an ironic screen shot from Poynter.org, which first reported Lehrer's fee, which Knight is referring to (also ironically) as an "honorarium."

Update 3: Aaannd...updated title to reflect that the speaker in question is in fact Jonah, not Johan, Lehrer.

Are You Ready for Some . . . Research? Uncertain Diagnoses, Research Data Privacy, & Preference Heterogeneity

As most readers are probably aware, the past few years have seen considerable media and clinical interest in chronic traumatic encephalopathy (CTE), a progressive, neurodegenerative condition linked to, and thought to result from, concussions, blasts, and other forms of brain injury (including, importantly, repeated but milder sub-concussion-level injuries) that can lead to a variety of mood and cognitive disorders, including depression, suicidality, memory loss, dementia, confusion, and aggression. Once thought mostly to afflict only boxers, CTE has more recently been acknowledged to affect a potentially much larger population, including professional and amateur contact sports players and military personnel.

CTE is diagnosed by the deterioration of brain tissue and tell-tale patterns of accumulation of the protein tau inside the brain. Currently, CTE can be diagnosed only posthumously, by staining the brain tissue to reveal its concentrations and distributions of tau.[1] According to Wikipedia, as of December of 2012, some thirty-three former NFL players have been found, posthumously, to have suffered from CTE. Non-professional football players are also at risk; in 2010, 17-year-old high school football player Nathan Styles became the youngest person to be posthumously diagnosed with CTE, followed closely by 21-year-old University of Pennsylvania junior lineman Owen Thomas. Hundreds of active and retired professional athletes have directed that their brains be donated to CTE research upon their deaths. More than one of these players died by their own hands, including Thomas, Atlanta Falcons safety Ray Easterling, Chicago Bears defensive back Dave Duerson, and, most recently, retired NFL linebacker Junior Seau. In February 2011, Duerson shot himself in the chest, shortly after he texted loved ones that he wanted his brain donated to CTE research. In May 2012, Seau, too, shot himself in the chest, but left no note. His family decided to donate his brain to CTE research in order “to help other individuals down the road.” Earlier this month, the pathology report revealed that Seau had indeed suffered from CTE. Many other athletes, both retired and active, have prospectively directed that their brains be donated to CTE research upon their death.[2] Some 4,000 former NFL players have reportedly joined numerous lawsuits against the NFL for failure to protect players from concussions. Seau’s family, following similar action by Duerson’s estate, recently filed a wrongful death suit against both the NFL and the maker of Seau’s helmet.

The fact that CTE cannot currently be diagnosed until after death makes predicting and managing symptoms and, hence, studying treatments for and preventions of CTE, extremely difficult. Earlier this month, retired NFL quarterback Bernie Kosar, who sustained numerous concussions during his twelve-year professional career — and was friends with both Duerson and Seau — revealed both that he, too, has suffered from various debilitating symptoms consistent with CTE (but also, importantly, with any number of other conditions) and also that he believes that many of these symptoms have been alleviated by experimental (and proprietary) treatment provided by a Florida physician involving IV therapies and supplements designed to improve blood flow to the brain. If we could diagnose CTE in living individuals, then they could use that information to make decisions about how to live their lives going forward (e.g., early retirement from contact sports to prevent further damage), and researchers could learn more about who is most at risk for CTE and whether there are treatments, such as the one Kosar attests to, that might (or might not) prevent or ameliorate it.

Last week, UCLA researchers reported that they may have discovered just such a method of in vivo diagnosis of CTE. In their very small study, five research participants — all retired NFL players — were recruited “through organizational contacts” “because of a history of cognitive or mood symptoms” consistent with mild cognitive impairment (MCI).[3] Participants were injected with a novel positron emission tomography (PET) imaging agent that, the investigators believe, uniquely binds to tau. All five participants revealed “significantly higher” concentrations of the agent compared to controls in several brain regions. If the agent really does bind to tau, and if the distributions of tau observed in these participants’ PET scans really are consistent with the distributions of tau seen in the brains of those who have been posthumously-diagnosed CTE, then these participants may also have CTE.[4]

That is, of course, a lot of “ifs.” The well-known pseudomymous neuroscience bloggerNeurocritic[5] recently asked me about the ethics of this study. He then followed up with his own posts laying out his concerns about both the ethics and the science of the study. Neurocritic has two primary concerns about the ethics. First, what are the ethics of telling a research participant that they may be showing signs of CTE based on preliminary findings that have not been replicated by other researchers, much less endorsed by any regulatory or professional bodies? Second, what are the ethics of publishing research results that very likely make participants identifiable? I’ll take these questions in order.

Outsourcing the Up Goering of My Job Talk Paper to Forbes

So, one thing they say about being on the law teaching market is that you likely will never before have enjoyed — and, less happily, will likely never again enjoy — so much attention to your work and so many opportunities to discuss it. That’s totally true, and it’s totally fabulous. But there’s a flip side of that that they don’t tell you: after a while, you get burned out on talking about the same paper over and over again. You’ve likely moved on to other projects and are more excited about them, even if (or because) those projects build on your job talk paper. At this point in the process, your recitation of your job talk paper may have become rote and uninspired. You may, like me, have come to dread the act of rattling off your job talk paper’s thesis and why it matters.

And so it is that, having promised some months ago to blog my job talk paper on what I call the “heterogeneity problem” in research regulation, that I have yet really to do so. I’ve blogged around the edges, to be sure (see, e.g., here, here, here, and here), but I can’t bring myself to explain the central thesis one more time. I also owe book editors a chapter on the challenges of heterogeneity for the growing global trend in "risk-based regulation" across many industries, and I’ve been procrastinating that, too, I think, largely because it requires me first to provide the reader with a précis of the heterogeneity problem. All of this is annoying, because there are lots of things that build on that central thesis that I’d like to write about, if only I could get over this strange aversion.

Enter physician-scientist David Shaywitz whose overly kind piece yesterday in the Pharma & Healthcare section of Forbes.com, Personalized Regulation: More Than Just Personalized Medicine — And Urgently Required, highlights my work and, essentially, Up Goers it for me. It of course doesn’t cover all of the points I make in the paper, and in other ways it extends my thesis beyond what I defend in the paper, but it gives readers the gist. Thank you, David! (Let this also serve as supplemental answers to hiring committee questions about “What does your work have to do with the law?” and “Aren’t you ‘just’ a bioethicist whose work has no relevance for health or administrative law?”)

And now, with that out of the way, in my next post I’ll feel free to apply the heterogeneity problem to this question I was asked on Twitter. I can almost guarantee you that it will be my first and last post about football.

Exempt Research & Expedited IRB Review: Curb Your Enthusiasm

A while back, over at PrawfsBlawg, Martin Pritikin had a useful post collecting advice for legal academics looking to break into increasingly popular empirical legal studies (ELS). As Jeremy Blumenthal notes in the comments, Step 1 is to be sure to get IRB approval. This post addresses what I’ll call, with a nod to Cass Sunstein’s work on Chevron deference, IRB Step Zero: Determine whether your research needs IRB approval at all.

Don’t worry, it’s an easy step: As Jeremy’s plenary admonition to all wannabe ELS scholars implies, the answer is almost certainly Yes. Although the regulations in theory establish three risk-based tiers of review — human subjects research (HSR) otherwise subject to IRB review that the regulations nevertheless exempt; HSR that is eligible for expedited review; and HSR that requires review by a fully convened IRB (everything else) — in practice, the first two tiers tend to collapse into the third. In this sense, and now I borrow from Matthew Stephenson and Adrian Vermeule, IRB review has only one step.

A quick note of clarification: As I’ve noted before (here and here), several projects I have in the works, beginning with Regulating the Production of Knowledge: Research Risk-Benefit Analysis and the Heterogeneity Problem, forthcoming next June in the Administrative Law Review, argue that we suboptimally regulate knowledge production. Just to be clear, my argument in that article doesn’t depend on my argument here about the broad scope of the regulations and their failed attempt to achieve risk-based levels of review.* Consider this post a public service for ELS types. That said, I draw here on The Heterogeneity Problem's background section, where interested readers will find the relevant citations.

Hey, IRBs: You're Doing It Wrong (But It's Not Your Fault). Also, Thanks a Lot, Toshiba

So I've just posted a draft paper on SSRN, "Regulating the Production of Knowledge: Research Risk-Benefit Analysis and the Heterogeneity Problem," the first of a pair of companion articles on, well, how we regulate knowledge production -- focusing on IRBs in particular and on the peculiar risk-benefit standard that pretty much every federal agency (and the governance frameworks of many other countries) requires them -- futilely, I argue -- to perform. As soon as I finish navigating the ExpressO/Scholastica maze, I'll be blogging about some of issues raised in this paper, its companion, and "Legal Experimentation: Legal & Ethical Challenges to Evidence-Based Law & Medicine," a workshop (and edited volume) I'm organizing this spring.

But for now, a few brief thoughts:

(1) I hate the title of the draft paper. It's hideous. I long for the concise elegance of Prison Vouchers or some of the others mentioned here. The companion paper is tentatively titled "Research Contracts." That's followed by the usual boring descriptive subtitle, of course, but I consider it a victory at least to have begun with the kind of title I aspire to. For the posted draft, though, I can't even manage to do that. "Hey, IRBs: You're Doing It Wrong (But It's Not Your Fault)" is a fair description, but seems a little glib for a law review article. So I'm all ears if anyone comes up with a less jargonistic, sleep-inducing title. (More importantly, and in all seriousness, I'm very open to feedback on the paper itself.)

(2) Toshiba is on my s*** list. Partly because I'm a die hard Mac person, but mostly because of Toshiba's latest ad campaign, embedded above, which stereotypically portrays research participants as the passive objects of mad scientists -- that is, as proverbial guinea pigs. Like other historically disempowered groups, career research participants have reclaimed that moniker. But Toshiba's customers don't know that, and its ad helps perpetuate the image of research participation as terribly dangerous and degrading and as something that only someone who is either irrational or desperate (and willing to be exploited) would agree to. In reality, research participants can and do initiate research, and in the increasingly popular Citizen Science and Quantified Self movements, the distinction between researcher and "subject" disappears altogether. It's also closer to the truth (ahem, Time Magazine) to say that a lack of experimentation has turned millions of us into human guinea pigs in the realms of health care and legal services, and as the subjects of any number of laws, regulations, and policies (see the "Legal Experimentation" prospectus, linked above). /Rant

Finally, An End—for Now—to Dickey-Wicker Sticky Wickets: On Stem Cell Research and Chevron Deference

Almost two years ago to the day, Chief Judge Royce Lamberth of the D.C. District Court shocked the human embryonic stem cell (hESC) research community by preliminarily enjoining NIH funding of that research, on the grounds that plaintiffs were likely to succeed on the merits of their argument that hESC research violates the so-called Dickey-Wicker Amendment (on which more below). Today, the D.C. Circuit affirmed Chief Judge Lamberth’s (reluctant) grant of summary judgment for the government, a holding that he had been essentially forced into by an earlier panel of the D.C. Circuit. (My co-guest blogger covers the other big decision coming out of the D.C. Circuit today, below.) Since it is extremely unlikely that the D.C. Circuit will review the decision en banc or that the U.S. Supreme Court will accept cert., today’s decision effectively ends litigation that caused utter chaos to erupt in labs all over the country in the wake of the preliminary injunction, and continued to cause significant uncertainty even after the D.C. Circuit quickly stayed that preliminary injunction. Congress could, of course, act to clarify the ambiguity in Dickey-Wicker. But this seems highly unlikely given the current partisan split between the House and the Senate. Indeed, the draft HHS appropriation bill that passed the subcommittee, on which I blogged previously, contains Dickey-Wicker’s familiar language, to the letter. The ambiguity regarding the legality of federal funding of hESC research seems, then, to have reached its low water mark during the past couple of years, and should stay that way…at least until November.

Background

For those of you who are close observers of this litigation: as you were (or skip to the section on today's opinions, below). For the uninitiated-but-interested: Some background. Federal policy regarding funding for hESC research has, since the beginning of this research in 1998, been extremely contentious, wrapped up as it is with ethical, political and diverse religious positions on the moral status of human embryos and other aspects of “abortion politics.” An embryonic stem cell line is so called because the line is derived from an embryo (really, a five-day or so blastocyst), and this process necessarily destroys that embryo. Despite that — or because of it — the funding policies under the Clinton, Bush and Obama administrations have been remarkably similar. In this article, published in September 2009 — one month after the litigation that no one thought would have legs had commenced — political scientist James Fossett and I analyzed these extent to which the Obama Administration’s guidelines for funding hESC research, then just announced by NIH, were likely to achieve two of their stated goals: (1) expanding NIH support for hESC research after what had been widely perceived by the science community as strict limits on it during the Bush Administration, and (2) ameliorating the patchwork of state and private regulatory standards that had come to govern this research in the absence of federal funding.

Misguided Genetic Exceptionalism

While society should be careful about its uses of genetic testing and its efforts to modify the genome, some people overreact when dealing with DNA. Consider two recent examples reported in the media.

A genetic cancer test. In a fascinating series on genetics in medicine, Gina Kolata reported in the New York Times on a genetic test for ocular melanoma. The test distinguishes between curable and fatal forms of the melanoma, yet some physicians do not offer the test to their patients (though they disclose the availability of the test).

Of course, some patients may choose not to know which type of melanoma they have. Both curable and lethal types are treated in the same way--surgical removal--and knowing that death is certain may be too unsettling for a number of patients with the fatal form.

But to not even offer patients the chance to know seems odd. If the diagnostic test were not a genetic one, I suspect the physicians would act differently. For example, if doctors were able to distinguish between curable and fatal forms of ocular melanoma when tumor cells were sent to the pathology lab for standard cellular analysis, there would not be the same reluctance to offer patients the opportunity to find out which kind of tumor they had.

To be sure, the fact that a particular medical test is genetic may increase the potential for concerns with the test. But many genetic tests do not pose any special problems. Physicians should not let a genetic label mislead them.

Fighting dengue fever. A second example of problematic thinking about genetics appeared in the New Yorker in an article by Michael Specter about genetic modification of the Aedes aegypti mosquito to eliminate dengue fever. If the mosquito can be eradicated, so can the dengue fever virus, which kills many and for which there is no vaccine or antiviral therapy.

Call for Fellowship Applications: Petrie-Flom Center at Harvard Law School

I'm passing on the following call for fellowship applications on behalf of the Petrie-Flom Center:

The Petrie-Flom Center for Health Law Policy, Bioethics, and Biotechnology at Harvard Law School is currently accepting applications for the 2013-2015 Academic Fellowship Program on a rolling basis through November 16, 2012.

The fellowship is designed for applicants who have the intellectual focus to make top-rate academics in health law policy, bioethics or biotechnology, and who would benefit from time to develop their ideas and writing before they enter the academic job market. Our prior fellows have found homes on the law faculties at Harvard, Berkeley, BU, UCLA, the University of Arizona, Cornell and the University of Illinois. The fellowships include stipends of $60,000/yr for two years, a research budget, limited benefits and access to the full range of the Center's and Harvard's facilities and research resources.

If you know of any well-suited candidate who might be interested, please direct them to the call for applications (pdf) to learn more.

House Saves Grandpa From the Death Panels—And Makes Him a Guinea Pig Instead

    In all the attention given in the past couple of years (to say nothing of the past couple of months) to the individual mandate and its effect on health care access, other key features of PPACA, which address other aspects of the health care system, have received less attention than they deserve. Two remarkable things happened yesterday that highlight the importance of addressing health care quality.

    First, newly published research suggests that each year in the U.S., more than 100,000 men undergo expensive, invasive surgeries that leave many of them impotent and/or incontinent, all without increasing their chances of survival or providing other clinical benefits.

    The New England Journal of Medicine published the results of what one oncologist not involved with the study called a potentially “game-changing” experiment involving men with early-stage prostate cancer. Most new diagnoses of prostate cancer are early-stage, and about 90% of those who receive this diagnosis choose immediate treatment with surgery (or radiation). But despite the considerable financial and human costs of the surgery, it’s not clear that the surgery actually improves patients’ odds or duration of survival.

    To examine that question, investigators randomly assigned 731 men either to surgical removal of the prostate or to an observation group, where the cancer was monitored but not treated unless it showed signs of progressing. After 15 years, there was no statistical difference between the two groups in terms of either overall mortality or mortality due to prostate cancer. A secondary analysis, however, suggested that surgery may benefit men with high Prostate Specific Antigen (PSA) levels.

    The results are complex, and an accompanying editorial argues that the sample size of 731 rendered the study insufficiently powered to draw conclusions about the comparative efficacy of surgery and watchful waiting. Notably, the investigators sought 2,000 subjects, but could only recruit 731, presumably because, in the face of a cancer diagnosis, being randomized to “watchful waiting” seems risky. But it’s precisely the point of health services research — and analogous research in other areas, including legal services, see, e.g., Greiner and Pattanayak’s RCT of Harvard legal aid offers — that what seems, based often on not much more than mere intuition (and perhaps a cognitive bias that favors action over inaction), to be the most effective option is not always so in fact.

    The second remarkable thing that happened yesterday is that the House proposed to gut federal involvement in health services research, a diverse category of research of which the prostate cancer study is but one example. And this, despite the fact that, historically, health services research has received only about 1% of the budget of NIH, the largest funder of basic biomedical research. Health services research evaluates, and often compares, actual health services delivery systems and interventions (e.g., treatments, diagnostics, or screening and other preventative measures), as they are implemented in actual practice settings.

    The House Subcommittee on Labor, Health and Human Services, Education and Related Agencies passed the spending bill for fiscal year (FY) 2013; it goes to full committee next week. Among other cuts, section 227 of the bill (see pp. 90-93) eliminates, effective October 1, 2012, the uber-wonky, but critically important, Agency for Healthcare Research and Quality (AHRQ). Located within HHS, the mission of AHRQ (which had a $405 million budget in FY 2012) is to improve health care quality, safety, efficiency, and effectiveness. AHRQ is the major funder of health services research. Among many, many other studies, for instance, it helped fund the prostate cancer study discussed above. It also studies, and tries to prevent, the medical errors that kill more than 100,000 people a year. The House bill, moreover, prohibits other agencies within the subcommittee’s jurisdiction from assuming AHRQ’s duties unless they already have statutory authority to do so.

    The vote to pass the bill fell along party lines, with the exception of Rep. Jeff Flake (R-Ariz.), who sided with the Democrats in voting against the bill because he wanted even deeper cuts. And indeed, one possible explanation for the House’s decision is that cutting AHRQ is a somewhat lamentable, but ultimately wise, choice in tight economic times. After all, why spend scarce time and money studying an intervention after it has been marketed, often after having endured rigorous approval processes like those imposed by the FDA?

    This thinking is short-sighted — and dangerous. Much medical practice — like surgeries — was never subjected to rigorous study before it became the standard of care. Much of medicine, in short, isn’t evidence-based. Hence the need for an active movement towards “Evidence Based Medicine.”

Broadening What We Talk About When We Talk About Innovation Law and Policy

Thanks very much to Dan and the other loungers for having me, and to Al for that very generous introduction. Owing to other projects, I’ll be posting a bit more sporadically, but hanging out a bit longer, than some other guests.

I have varied interests, but of late, I’ve been obsessed with what is generally known as “human subjects research” (HSR) and with the institutional review boards (IRBs) that review it. I’ll talk about some of my own work in this area in later posts, but for now let me explain why readers of The Faculty Lounge care about HSR and IRBs — even if you don’t know it.

In legal scholarship and education, innovation law and policy is almost synonymous with intellectual property in general, and with patent law in particular. This, I think, is a mistake.

We can all agree that incentives to engage in knowledge-producing activities are important, even as we disagree about whether the current patent system in fact provides optimal incentives and about what values we should be trying to maximize when we establish those incentives. But one of the things that gets lost in our focus on patents, technology transfer, and so on is the next step in the innovation chain: optimal incentives to engage in knowledge-producing activities will be of little use if the regulation of knowledge-producing activities themselves is suboptimal.

Innovations with the potential to affect human welfare at some point generally have to involve human beings. That’s where HSR comes in. In the law school curriculum, HSR tends to be relegated to the final weeks of courses in health law or FDA law (themselves often marginalized in the curriculum, if they are offered at all). But this curricular choice rests on a conflation of HSR with biomedical research in general, and with pharmaceutical drug trials in particular.

This narrow focus doesn’t remotely match the regulatory reality, which is that virtually every research methodology (not only randomized, controlled trials but also data collection and analysis, online Stroop tests, surveys, interviews, and even simple observation) and academic discipline (not only biomedicine and psychology but every social science, many humanities and, yes, empirical legal studies) is subject to federal regulation, including prospective review by an IRB.

In later posts, I’ll have more on the breadth of the current regulatory framework, what that framework entails, how we got here, what’s wrong with the current system, and what might be done about it. For now, let me suggest that the regulations governing HSR should be of concern to scholars of innovation law and policy (because HSR is a critical link in the innovation chain), to virtually all other scholars (because their work is, or easily could be, considered HSR and thus subject to regulation, even if many of them don’t realize it), and — most importantly — to citizens (because you presumably want the laws and policies to which you are subject to be evidence-based, and that depends on being able to conduct well-designed, generalizable HSR without undue delay, cost, or restriction).

Thanks again to Dan, Al, and the other loungers for letting me hang around the lounge. I look forward to the conversation.

Permanent versus Temporary

Bridget's post about Texas got me  thinking about perpetuity.

I spend most of my time thinking about land conservation these days. In particular, I have been obsessed with intrigued by conservation easements.

Conservation easements are like those restrictive covenants and easements we muddled through in our property classes. Although the details differentiating them are unimportant here, one key selling point of conservation easement is that they can be (and in many cases must be) perpetual. One of the more controversial arguments I have made recently is that conservation easements should not last forever. While I have no intention or need to reopen  that debate here, I was surprised to stumble across an a recent article from the journal Biological Conservation. In Temporary Conservation for Urban Biodiversity, the authors argue against prioritizing brown fields for redevelopment. Specifically, they argue that leaving sites vacant temporarily (their study suggests 15 years) will increase urban biodiversity.

There are a lot of caveats here of course. Their case study is from Bremen, Germany where land-use planning laws and paradigms differ. They are only talking about what to do with brownfields, not benefits that may or may not accrue from greenfield conservation. And yet, I am still fascinated by this article. Land conservationists generally argue that brownfields should be developed instead of greenfields and that when we do preserve land, we should preserve it for as long as possible (preferably forever). This article challenges those assumptions.

Posner on Foley (on Blobs)

Eric Posner reviews Elizabeth Price Foley’s The Law of Life and Death (HUP) in The New Republic.

An excerpt:

In eighty years or so, the average American goes from blob to person to blob. The middle phase of this continuum jangles with the bells and whistles of personhood—rights, interests, human dignity, legal protections, the works. The blobs are, at one end, an invisible bunch of cells and, at the other, a mass of putrefying flesh material. The blob-person and person-blob transitions give ethicists, legislators, and judges a great deal of trouble. How does the law keep up as the initial blob advances to human being, and then the human being degrades to blobness? 

 

Access to Medicine in the Global Economy

For those interested in the intersection between patent law and access to medicine in the global trading arena, I would recommend Cynthia Ho's new book, Access to  Medicine in the Global Economy:  International Agreements on Patents and Related Rights.  The book touches on different theoretical perspectives relating to patents and related rights, and how those perspectives might impact interpretations of international treaties on IP (such as TRIPs) as applied to manufacture and distribution of medicines globally.  A very useful and much-needed addition to the literature.

What Happens When You Find the FBI's GPS Tracker on Your Car

Over at Wired there's an interesting story describing what happened when a 20 year old found the FBI's GPS tracker that was surreptititously placed on his car.  At right is a picture of the device courtesy of the Wired story.  Apparently the target of the surveillance brought his car in for an oil change.  The mechanic saw a wire sticking out from underneath the car and pulled out the device.  The target of the surveillance posted photos of the device on-line to find out what it was.  It turns out the device is an Orion Guardian ST820 an older model GPS tracking device.  Not surprisingly, it didn't take long for the FBI to show up at the target's door demanding their device back. 

The target of the surveillance is Yasir Afifi, a U.S. born citizen, business student and son of an Islamic-American man who died in Egypt last year.  The ACLU has jumped onto the case declaring to Afifi "This is the kind of thing we like to throw lawyers at."  According to the report, "Brian Alseth from the American Civil Liberties Union in Washington state contacted Afifi after seeing pictures of the tracking device posted online and told him the ACLU had been waiting for a case like this to challenge the ruling."

A very interesting story, well worth the read. 

 

The Corporate Governance Debates Invade Botany (Or, Australia May or May Not Be Ready for a Female P.M., But It Will Always Have Acacias)

My next door neighbor and good friend is a noted evolutionary biologist at Harvard.  He's a theorist (not an experimentalist) with unbounded curiosity and good fellowship (thus, not surprisingly, an Aussie to boot).  One of my favorite pastimes of a late Friday or Saturday afternoon is to share a bottle of varying grades of wine and BS on subjects that invoke, among other things, law, adaptation, selection, philosophy of science, consciousness, game theory, and faculty politics.  This is merely to explain how I happened to get two papers from the scientific journal Taxon (Issues 2 (pages 613-616) and 4 (1188-1195) of Volume 59), which came out in April and August of this year.  He thought that I, as a lawyer, would find the subject matter interesting, and handed the pages over the fence early yesterday morning.  I do, because it sounds so much like the debates over corporate governance, namely, is the institution being governed a representative democracy or not?  (Full disclosure:  I have no clue about the International Botanical Congress, but I tend to side with people like Steve Bainbridge on the shareholder democracy issue:  a corporation is NOT a democracy.  That's because I don't buy the democracy metaphor to begin with, but more of that below.)

This is apparently a raging issue in the field of botany, but it takes a while to understand just what's at stake here.  The issue is one of botanical nomenclature.  There are substantive and procedural rules and recommendations for "conserving" the name of a genus, and they are set forth in the International Code of Botanical Nomenclature (the "Code").   It looks to me like it's the analog to what ICANN does for domain names:  making sure that there is uniformity in the use of particular signs as identifiers of something, whether it's a page on the World Wide Web, or a particular kind of plant or organism. 

In 2005, somebody proposed that the name Acacia Mill. be conserved with a new type (Acacia penninervis Sieber ex DC.) lest something like 1000 taxonomic groupings in Australia be required to go by a new name Racosperma Mart.  The effect of this would be to deny the name Acacia to the African-Asian A. scorpiodes (L.) W. Wight (= A. nilotica Karst.).  As you can imagine, the Scorpiodes camp objected to the attempt of the Penninervis camp to appropriate the Acacia name by way of taxonomic legislation at the 2005 Intenational Botanical Congress in Vienna.

But the botanical community is now beyond the merits of the debate and into matters that invoke the very rule of law.  The reason is that the Nomenclature Section debated and voted on the issue, and rejected the proposal, with 45.1% in favor, and 54.9% against.  But to quote the paper at 59 Taxon 1188 (2010):  "Surprisingly, the proposal was treated as having been approved by the Section's administrators, who ruled that it only needed to receive a 40% positive vote to be approved."  Here are the argument headings in the paper:

(1) Use of Article 14.14 allowing only a 40% positive vote for passage of [the Acacia proposal] was unjustified.

(2) Decision-making authority to amend the Code lies with the Nomenclature Section and International Botanical Congress, not with any Committee.

(3) Decisions are made only through a majority vote.

(4) The Vienna Nomenclature Section's own rules of procedure were not followed during the vote on [the Acacia proposal].

Can a corporate board take action (say, instituting a poison pill or maintaining a classified board or a particular executive compensation scheme) that, in its judgment is in the best interest of the corporation and the shareholders, even if a majority of the shareholders disagree?  Under the governance provisions of the Code, can the General Committee (which is composed of the secretaries of the other Committees [Spermatophyta, Pteridophyta, Bryophyta, Fungi, Algae, and Fossil Plants], the rapporteur-général, the president and the secretary of the International Association for Plant Taxonomy, and at least 5 members to be appointed by the Nomenclature Section) conserve or reject botanical names in the best interest of the scientific world as a whole, even if a majority of the members of the Nomenclature Section disagree?

Well, I think this turns out to be a metaphor problem, akin to the burning question whether Goldman Sachs's role in marketing synthetic CDOs is more aptly seen as "bookie" or "trusted confidant."  Is representative democracy the appropriate metaphor for corporate entities or scientific congresses?  Inquiring minds want to know.

Heroes, Dopers, and Superhumans

 As I noted in my last post, the Tour de France has begun, meaning that it is also time for the annual hand-wringing and head scratching about sports doping issues.

The last issue of New Scientist has an interesting article on the topic:

Each extraordinary performance in the race will, however, generate suspicion as well as admiration. Allegations of doping have plagued the Tour for so long that any rider who excels now inevitably attracts talk of drug use.

But what if a superhuman performance itself could be used as evidence of doping? That's the thinking behind a new strategy, which asks: "Is this physiologically possible without the aid of drugs?"

The idea is straightforward: work out the boundaries of human ability, based on what we know about physiology and its maximal capabilities. If an athlete's performance lies outside this limit, they are highlighted as a potential drug-taker and given more frequent and extensive drug screenings.

 The article notes that, prior to widespread EPO use, Tour winners' average power output was 380 watts on big climbs, with none exceeding 410 W.  From 1994 onwards, when EPO use became more widespread, about six riders per year averaged over 410 W.  Levels then dropped at the end of the decade as EPO testing improved, then rose again after 2000. Similar advances have been seen in VO2 max measures. (The Science of Sport also has some good posts on point here and here).

The article asks:

 

Do these high levels reflect a leap in human achievement, or are they a signature of artificially enhanced physiology? . . .

 

On the basis of a person's physiological measurements alone, it is impossible to say otherwise. "Doping can never be inferred from performance only," says Schumacher.

 

During last year’s tour, I blogged about sports doping, the suspicions raised by Contador’s record-breaking climb on the Verbier, and about the differing takes of Michael Sandel and Richard Posner on the sports doping issue (which I just reposted yesterday).   And I’m sticking by my heretical contention that the Tour is less interesting in the absence of doping – it’s precisely these types of superhuman efforts that we love to watch. As I said in that post, Vive Le Tour! Vive Le Dope!:

We loved Contador’s heroic feat on Verbier – it was exciting.  Just like we loved Floyd Landis’s epic 2006 comeback; Tyler Hamilton’s superhuman 142 km solo breakaway, stage win, and fourth-place GC finish with a broken collar-bone; and Vinokourov’s spectacular mountain-top breakaway.  Because, as Phil says in this video of the relevant Vino footage, “everyone loves a fighter.”

 

. . . Until we found out they were all doping, that is.

 

Maybe the Tour exists because – not in spite – of doping.  And it’s a wonderful spectacle. Vive le dope! Vive le tour!

Photo: me (or, at least, my hand) showing off entry passes to the Nike box on the final 2008 stage on the Champs-Élysées (thanks Martha!)

Image Source (AG2R La Mondiale rider Lloyd Mondory of France gestures after he crashed near the finish line of the 1st stage of the Tour de France cycling race from Rotterdam to Brussels yesterday).

iPhone 4

Are you considering adding the new iPhone 4 to your technology arsenal?  Houston Chronicle columnist Dwight Silverman has a favorable review here.

Aaron (Hank and Tommie), Brett (George and Ken), Conigliaro (Billy and Tony), Etc.: Sibling Behavior On The Diamond

Readers with an interest in both baseball and sibling behavior may find interesting a recent article entitled Birth Order and Risk Taking in Athletics:  A Meta-Analysis and Study of Major League Baseball, published in the current issue of Personality and Social Psychology Review and co-authored by Frank Sulloway and Richard Zweigenhaft.  Here's the abstract:

According to expectations derived from evolutionary theory, younger siblings are more likely than older siblings to participate in high-risk activities.  The authors test this hypothesis by conducting a meta-analysis of 24 previous studies involving birth order and participation in dangerous sports.  The odds of laterborns engaging in such activities were 1.48 times greater than for firstborns (N = 8,340).  The authors also analyze performance data on 700 brothers who played major league baseball.   Consistent with their greater expected propensity for risk taking, younger brothers were 10.6 times more likely to attempt the high-risk activity of base stealing and 3.2 times more likely to steal bases successfully (odds ratios).  In addition, younger brothers were significantly superior to older brothers in overall batting success, including two measures associated with risk taking.  As expected, significant heterogeneity among various performance measures for major league baseball players indicated that older and younger brothers excelled in different aspects of the game.

I am unable to find a free-access link to the article.  But The New York Times discusses the article in this story.

Trivia question:  which trio of brothers aggregated the most career hits?  Click here for the answer.

Hubble Telescope - 20th Anniversary

Today is the 20th anniversary of the launch of the Hubble telescope and the telescope's latest image has just been released:

For an archive of images and full story, see here.