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“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 »

Vermont to Pass GMO Labeling Law

Malia McPherson

Although Ben & Jerry’s, “Vermont’s Finest” ice cream, already committed to GMO labeling by the end of 2014, their state’s law will now be close behind. On April 23, the Vermont House gave final approval to a bill that will require labeling on foods containing genetically modified ingredients. Gov. Peter Shumlin tweeted that he would sign the bill into law, making Vermont the first state in the U.S. to mandate such labeling. Once the bill takes effect July 1, 2016, all Vermont-retailed foods with more than 0.9% of their total weight in genetically modified ingredients must be labeled with language stating, “may be partially produced with genetic engineering.” Although Connecticut and Maine passed labeling laws in 2013, their statutes stipulate that at least four nearby states pass similar laws before the requirements go into effect. The full, amended statute that passed the Vermont House and Senate can be found here.

But as NPR reported, Vermont’s attorney general is “bracing for a battle” — the bill itself established a $1.5 million fund to help defend against anticipated lawsuits. At stake are free speech issues, federal preemption, and agro-business pushback. Although we will have to “wait-and-see” what legal battles ensue, it is interesting to speculate. Who will fire first: General Mills, Monsanto, the FDA??

Malia McPherson is a first year JD student at Stanford Law School and an officer of its BioLaw organization.

A Second Zohydro Update

Last week I posted about Judge Rya Zobel’s order enjoining the Massachusetts Zohydro ban. While writing that post, I was wondering how Massachusetts would respond to the injunction. Now we know the answer. The night before the injunction was to go into effect, Governor Deval Patrick announced that the state would not appeal Judge Zobel’s order, and, instead of an outright ban on the use of Zohydro, Massachusetts would impose certain restrictions on its use similar to what Vermont has done.

The restrictions that Massachusetts has imposed include requiring Zohydro prescribers to complete a risk assessment and pain management agreement with patients, and participate in Massachusetts’s Prescription Drug Monitoring Program, which collects dispensing information on controlled substances to detect misuse.  If Zogenix chooses to challenge these restrictions – and I’m guessing it won’t because it hasn’t yet sued Vermont over its similar restrictions – one legal question would be: Are these restrictions, like the outright ban, preempted by federal law?

Read the rest of this entry »

Zohydro Update

Since FDA approved Zohydro in October 2013, the drug has been the subject of quite a bit of controversy.  In short, the concern is that Zohydro will contribute to the serious prescription drug abuse problem in the U.S. because, as an extended-release drug, it contains a higher dose of hydrocodone than other hydrocodone drugs on the market, and it lacks abuse-deterrent properties (see, e.g., this New York Times blog post).  Perhaps the most interesting part of this controversy is that Massachusetts has attempted to ban the use of Zohydro in that state—which I think makes Massachusetts the first state to flat-out ban an FDA-approved drug.

As we discussed in our recently posted April podcast, Zogenix Inc., Zohydro’s sponsor, sued Massachusetts over this ban (here’s the complaint).  When we recorded the podcast, the federal judge – Judge Rya Zobel of the District of Massachusetts – had not yet ruled on Zogenix’s motion for a preliminary injunction, and I predicted that she would not enjoin Massachusetts from enforcing the ban on preemption grounds.  Well, I was wrong.  On April 15th, Judge Zobel enjoined Massachusetts from enforcing or implementing its Zohydro ban because she concluded that Massachusetts “obstructed the FDA’s Congressionally-given charge” when it “interposed its own conclusion about [Zohydro’s] safety and effectiveness” (here’s the order).

Read the rest of this entry »

April Podcast

Podcast Listeners: Our April podcast is up! Listen to us talk about Zohydro, Ebola, biosimilars, and the Ninth Circuit’s en banc decision in Haskell v. Harris.

New Podcast: Top 5 Law and Bioscience Events of 2013!

Podcast Listeners: Our long lost December Podcast is up! Listen to us discuss what we think were the top 5 law and bioscience events of 2013.

Final Batch of 2014 CLB Workshop Mini-Podcasts!

The last two of our mini-podcasts with the 2014 CLB Workshop speakers are posted! Listen to Victoria Stodden (Columbia) discuss data transparency, and Ryan Abbott (Southwestern) discuss off-label use of drugs and devices.

Can Genome Editing Cure AIDS?

Hinco Gierman

Yes. At least, in theory. But, theory might soon become practice according to this week’s issue of the prestigious New England Journal of Medicine [1]. It published the first clinical trial of genome editing, in which the DNA of 12 human volunteers was “edited” to make them “genetically resistant” to the HIV virus.

What do I mean by genome editing and is it safe? How is this different from other gene therapies? Why would this cure AIDS? Is it unethical to genetically modify humans? And of course most importantly, should we be worried about “genetically modified super-humans” taking over the planet?

Read the rest of this entry »

Breaking News – Ninth Circuit En Banc Opinion “Affirms” Haskell v. Harris

Just released, the Ninth Circuit en banc, has affirmed the ND Ca decision (by Judge Charles Breyer) upholding California’s statute requiring people arrested for [corrected – thanks, Paul!]  any felony to provide DNA samples for inclusion in the state (and ultimately federal) database.

Sort of.

Read the rest of this entry »

March Podcast

Podcast Listeners: CLB’s March Podcast is up! Listen to us discuss Myriad Genetics and preliminary injunctions (01:25-11:59), the (in)accuracy of whole genome sequencing (12:00-13:27), tooth whitening and federal antitrust law (13:28-23:16), the ethics of mitochondrial transfer (23:17-34:14), and the (in)accuracy of a new blood test for Alzheimer’s disease (34:15-36:44).

New CLB Workshop Mini-Podcast!

Our latest mini-podcast is up!  Listen to Prof. Francis Shen (Minnesota) discuss neuropolitics with CLB’s Hank Greely.

Heather Has Three Parents

In the 1990s the children’s book, Heather Has Two Mommies, caused an uproar.  To some people, the very title was ridiculous and, all by itself, seemed a powerful argument against childrearing by lesbian (or gay) couples.  Today, it is more likely to provoke a “so what?”

Earlier this week an advisory committee of the U.S. Food and Drug Administration considered a proposal from Oregon researchers to begin human trials of a procedure for giving one woman’s eggs mitochondria from a different woman.  One of arguments reminded me a lot of Heather. The NPR story on the FDA hearings started its discussion of the objections this way:

“One [objection] that’s got a lot of attention is that any babies made this way would technically have three genetic parents, they’d have DNA from the father’s sperm, from the mother’s egg, and from the woman who donated the healthy mitochondrial DNA.”

Alas, the reporter didn’t follow that statement with “so what?”  But I will, after a little background.

Read the rest of this entry »