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Video of CLB’s Genetic Testing Conference is Available!

If you missed our October 13th conference on how the United States should regulate genetic testing, you can now watch video of the conference.  It was a fascinating day, with speakers from industry, government, professional associations, genetic counseling, and academia contributing their perspectives.  Check it out here!

You Don’t Miss the Cow Until the Barn is Empty*

As someone with training in both neuroscience and the law, it is maybe not surprising that I’m inclined to think (speculate, worry, etc.) about how current and future scientific and technological advances might affect society for good or bad. Luckily for me, as a fellow with the Stanford Program in Neuroscience and Society (SPINS) it’s also my job to think and write about these things, and so I do. I also read the work of many others—scientists, ethicists, lawyers, and journalists—who think and write about these issues.

But living and working in the microcosm I do, it’s easy to suffer from distorted perception—specifically, to make certain incorrect assumptions about how others process the topics I think about daily. I recognize that not everyone shares my position on a particular issue. But this recognition, in itself, overlooks a third option: that many simply may not care about the issue as much as I do. Or maybe even at all.

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2014-2015 Workshop Series: Mini-Podcast with Teneille Brown

Check out our latest mini-podcast with CLB workshop speaker Teneille Brown (University of Utah). Teneille spoke with Hank Greely about her paper “Cancer Exceptionalism and False Hope at the End of Life.”

Tun-Jen Chiang on Patentable Subject Matter

Patent law is usually justified on utilitarian grounds. To be sure, significant contrary views have appeared in recent scholarship. For example, Professor Robert Merges’ work provides a partly Lockean  account of intellectual property. The dominant view, nonetheless, is that the rules of patent law serve consequentialist goals of inducing invention, commercialization, and disclosure.  In support of this view, scholars often cite the moribund state of the “moral utility” doctrine and the Constitution itself, which empowers Congress to enact laws that would “promote the Progress of Science and Useful Arts.” Professor Tun-Jen Chiang’s forthcoming article, “Competing Visions of Patentable Subject Matter,” challenges this account as a descriptive matter insofar as it relates to the judicially recognized exclusions from patentability.

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Friedman & Lithwick on King v. Burwell: Stay Calm and Stay Calm?

Barry Friedman and Dahlia Lithwick have a post in Slate entitled “Obamacare Is Doomed! Everybody Panic!” Here.

I regularly read, enjoy, and respect SLS grad Dahlia’s work and I hope she and Professor Friedman (of NYU) are right.  And they are clearly right that panic is a not good reaction.  Panic is the worst emotion: never useful and never even enjoyable. I recommend in this case concern and righteous anger.

Cases do get taken without circuit splits, sometimes in situations of overwhelming importance, sometimes when the Court thinks a lower court decision is just blatantly wrong.  These subsidies don’t seem, to me at least, to fit the first category. I worry, a lot, that at least four and maybe five justices think they fit the second.

Friedman and Lithwick argue that this is a case that is important to decide quickly because of the disruption a negative ruling would cause.  But why, exactly, would finding out in June 2015 that you won’t have health insurance be less disruptive than finding out in, say, February 2016?

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Bad News for Obamacare – and America

Or so I think.

On Friday, November 7, the U.S. Supreme Court agreed to hear (granted the petitioner’s writ of certiorari) in King v. Burwell. In King, a panel of the Fourth Circuit unanimously rejected the argument that the federal government cannot, under the Affordable Care Act, subsidize low income consumers who buy health plans in the 36 states where the federal government, and not the states, runs the system’s “health exchanges.”

As a fan of this expanded health coverage, I think that’s bad because it puts that expansion at risk based on a drafting glitch in the Act. More broadly, though, I think it is bad because the Court’s decision to take a case like this now, with only one appellate court decision on the topic, looks unnecessary, political, and, indeed, partisan. And that, too, is bad for the country ­– and the Court.

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Audio of Prof. Mello’s Talk Is Posted!

For those who missed it, audio of Prof. Michelle Mello‘s really interesting talk, “Clinical Trials and Big Data: Moving Forward with Data Sharing,” is now available.  Listen here!

Not Just Another Expanded Access Reform Proposal

Last week, the Wall Street Journal’s Pharmalot blog reported that Rep. Michael McCaul (R-Tx) plans to introduce legislation to reform expanded access.  (Expanded access, or compassionate use, refers to the use of an investigational drug outside of a clinical trial, when the purpose is to treat a patient’s serious or life-threatening condition, rather than to study the drug.)

If you’re familiar with FDA’s expanded access regulations and their history, you might be underwhelmed by this news.  There have been many efforts aimed at reforming expanded access – from litigation to proposed federal legislation to recently enacted state legislation – which generally have focused on the government allowing patients access earlier in drug development and with fewer safeguards (or obstacles, depending on your perspective).  Usually, these proposals haven’t focused on what many identify as the real barrier to access: industry’s understandable reluctance to provide unapproved drugs outside of clinical trials.*

Rep. McCaul’s proposal, however, sounds somewhat different than past reform efforts.

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Is Another Mass-Market tDCS Device Imminent?

Roland Nadler, SLS, ’15

One of the most important developments in the history of transcranial direct current stimulation (a non-pharmacological cognitive enhancement technology I have covered in previous posts) has been the advent of commercially available brain stimulation devices.  The most widely used mass-market device is foc.us, which is advertised as a brain-boosting device for competitive video gaming.  A forthcoming empirical study from one of my Stanford Law colleagues has found that the practice of do-it-yourself brain stimulation changed significantly when foc.us became available.  No surprise — many curious would-be brain-zappers, suddenly spared the challenge of tinkering together a homemade tDCS device, were suddenly provided with the opportunity to purchase one ready-made.  An influx of neophyte users to online DIY communities followed.

We might be poised for another such influx.  Businessweek has reported that a startup with the so-Silicon-Valley-it-hurts moniker Thync has drummed up $13 million in venture capital funding (from the firm of notorious and legally beleaguered beach-blockading tycoon Vinod Khosla).  Their goal?  To bring a tDCS device to market for end-users within a year.  Now, $13 million may sound like hardly a sneeze here in the Valley’s biotech sector, but as capital for medical technology goes, it is substantial.  Given the well-established nature of the underlying technology, I do not think there is much reason to doubt that Thync will deliver on its promise to create and sell this product.

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2014-2015 Workshop Series: Mini-Podcast with Anna Laakman

Our mini-podcast with the first speaker in our 2014-2015 workshop series is up! Listen to Hank Greely and Anna Laakman (Lewis and Clark) discuss Prof. Laakman’s paper, “The New Genomic Semicommons.”