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Tailored Drug Ads: Creepy or Who Cares?

Yesterday, Bloomberg reported that drugmakers are working with third-party companies to link pharmacy records with online accounts, to tailor drug ads to a person’s particular needs.  In other words, if you buy drug X at the pharmacy – the example drug trotted out in the Bloomberg piece is Viagra – a drugmaker will know you bought drug X, and will tailor online ads accordingly (buy more of drug X! buy drug Y, which treats the same condition as drug X! etc). The links between pharmacy records and online accounts, called “matchbacks,” are made without names changing hands, meaning drugmakers don’t know the names of the patients that they are targeting with particular ads.  But, nevertheless, a number of quotes in the article raise privacy concerns.  And when I tweeted this story, my spouse’s immediate response was “creepy.”

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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.”

Ebola: The Tolling Bell

As of September 28, the World Health Organization (WHO) estimates that, so far, over 7100 people have been infected with and over 3300 have died from the Ebola virus. These estimates of what has happened are almost certainly far too low; the estimates of what will happen are terrifyingly high. The current Ebola epidemic may well become the worst human disaster in this century. And we are not doing enough about it. Read the rest of this entry »

“How Should the U.S. Regulate Genetic Testing?” Conference Registration Now Open

On Monday, October 13, the Stanford Center for Law and the Biosciences will present a free, full day conference on “How Should the U.S. Regulate Genetic Testing?”  We have a line-up of speakers from industry, professional groups, payors, academia, and governments, including the FDA, to discuss this timely issue.  The conference is free and open to the public, but we do require registration so we can guarantee you a seat (and a free lunch!).  Follow this link for a list of speakers, a registration “button,” and other details.

Hank Greely

Director

Stanford Center for Law and the Biosciences

Another New Podcast!

Podcast listeners: The September 2014 podcast is up!  Hear us discuss biosimilar drugs, popular brain myths, orphan drugs, and the ebola crisis.

The Risks of Risk-Averse Biomedical Research Funding

A recent NPR piece tells the story of two successful biomedical academic research scientists who left science entirely to pursue other interests. Ian Glomski abandoned a career in microbiology at the University of Virginia to start a liquor distillery. And Randen Patterson, a physiologist, left U.C. Davis to become the owner and manager of a grocery store.

According to Glomski and Patterson, these radical career moves resulted from the current tight funding situation for biomedical research. As Glomski explained, the scarce resources have created a situation where he could find funding only for very conservative and incremental research. Meanwhile, the more exciting projects that truly sparked his interest were deemed too risky and went unfunded. The result, for Glomski:

“You’re focusing basically on one idea you already have and making it as presentable as possible. You’re not spending time making new ideas. And it’s making new ideas, for me personally, that I found rewarding. That’s what my passion was about.”

So he moved on. Read the rest of this entry »

Sean Seymore on Utility

In patent cases, the term “hindsight bias” refers to fact-finders’ tendency to use their knowledge of the invention at issue in their analysis of whether that invention would have been obvious. This error occurs when fact-finders ignore the rule that obviousness of a claimed invention must be evaluated at the time of patent filing rather that at the time of litigation. Professor Sean Seymore’s latest article, Foresight Bias in Patent Law, deals with an error that implicates the future rather than the past. Seymore is concerned with the utility requirement, which denies patents on chemical compounds that lack a demonstrated consumer end use, such as a therapeutic use, and on methods of making such compounds. Foresight Bias builds on Seymore’s earlier article, Making Patents Useful, which criticizes the utility requirement for being too subjective and calls for its elimination. Seymore’s work may be contrasted to that of Professor Michael Risch, who sees a greater role for the utility requirement (see also here). Read the rest of this entry »

Fall 2014 CLB Workshop Speakers

CLB’s Workshop brings leading law professors and other academics from throughout the U.S. to present papers of interest to Stanford students, faculty, and members of the community. In previous years, the Workshop has covered a variety of topics at the intersection of law and the biosciences, including bio-patents, DNA privacy, reproductive rights, science policy, bioethics, health insurance, neuro-law, and others.

This year the CLB Workshop Series will be held over both fall and winter quarters.  The Fall Workshop Series will begin on October 7, 2014. All of the fall talks run from 4:15 p.m. to 6:30 p.m. in room 285 at Stanford Law School. We have a great line-up for the fall, and all students, faculty, and members of the Stanford community are welcome to join us for these talks!

Fall 2014 CLB Workshop Speakers:

October 7: Anna Laakman (Lewis & Clark): The New Genomic Semicommons

November 4: Teneille Brown (Utah): Hope at all Costs: Medicare Reimbursement for Cancer Treatment

November 11: Tim Caulfield (Alberta): The Obesity Gene and the (Misplaced) Search for a Personalized Approach to Our Weight Gain Problems 

November 18: Michele Bratcher Goodwin (UC Irvine): Biological Determinism: The Constitutional Implications When Law Gets Its Science Wrong

The Zohydro Saga Continues

Regular readers of this blog will know that for some time I’ve been following state reactions to FDA’s October 2013 approval of Zohydro, an extended-release oral formulation of hydrocodone that has sparked concerns about abuse because, among other reasons, it lacks abuse-deterrent properties.  To recap, last spring Massachusetts banned Zohydro, becoming the first state that I know of that has banned an FDA-approved drug (see our April 2014 podcast and my blog post here).  After a federal judge enjoined the Massachusetts ban on preemption grounds, Massachusetts joined Vermont in imposing restrictions on the use of Zohydro that fall short of an outright ban (see a second blog post here).  Well, the saga continues.  Now the Governors of Massachusetts and Vermont, along with the Governors of Connecticut, New Hampshire, and Rhode Island, are taking a new tack: they wrote to the Secretary of the Department of Health and Human Services (HHS) to ask that she “overturn” FDA’s decision to approve Zohydro.

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New Podcast!

Podcast listeners: Our long-lost May 2014 podcast is up!  Hear us discuss state “right-to-try” laws and access to unapproved drugs; patents, transcatheter heart valves, and life and death; Vermont’s law requiring labeling of genetically engineered foods, and; neuroscience and Johnny Cash.

Predicting Alzheimer’s Disease: Potential Ethical, Legal, and Social Consequences

(This post oriignally appeared, in very slightly different form,  in the Neuroethics Blog on June 17, 2014, here.)

Would you want to know the date and time of your death? Life-Line, the first published fiction by Robert A. Heinlein, one of the giants of 20th century science fiction, explored that question. The story’s protagonist, Hugo Pinero, had invented a machine that could tell precisely when individuals would die, but, as Pinero found to his distress, he could not intervene to change their fates.

Would you want to know whether you would be diagnosed with Alzheimer disease (AD)? This question is rapidly leaving the realm of science fiction; indeed, it already has for some unlucky people. Our ability to predict who will suffer from this evil (and I chose that word carefully) condition is proceeding on several fronts and may already be coming into clinical use.

This post will briefly note the ways in which AD prediction is advancing and what some of the ethical, legal, and social implications of such an ability would be, before asking “should we care?” Read the rest of this entry »