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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.

Read the rest of this entry »

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 »

“NeuroRacer” Creator Gazzaley Seeks FDA Blessing for Brain Training Game

Roland Nadler

Three of my favorite topics — cognitive enhancement, administrative law, and video games — have collided in the headlines this weekend, with several games and tech news outlets reporting on a University of California San Francisco professor’s newly announced bid for U.S. Food and Drug Administration recognition that his lab-developed video game, NeuroRacer, is a safe and effective device for the treatment of cognitive decline in the elderly.

Read the rest of this entry »