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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 »

“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.

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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?

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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).

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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?

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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.

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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.

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New CLB Workshop Mini-Podcast!

CLB’s latest mini-podcast is up!  Listen to Jill Horwitz (UCLA) discuss workplace wellness programs with CLB’s Hank Greely.

FDA Reconsidering How it Regulates (Most) OTC Drugs

Last Friday, FDA announced a public meeting to obtain input on reworking the system through which it regulates most* over-the-counter (OTC) drugs, known as the “OTC monograph system.”  This is big, and important, news.

OTC drugs are widely and routinely used, and are big business (in 2012, we spent 29.3 billion dollars on OTC drugs in the U.S.).  Yet most OTC drugs are not “approved” by FDA.  Instead, FDA publishes regulations, known as monographs, that set out what are, essentially, lists of permissible ingredients and labeling claims for therapeutic categories of OTC drugs (e.g., laxatives, antacids).  If a drug meets the standards published in the relevant monograph, a company may sell the drug without pre-market approval from FDA.  Sounds reasonable enough.  But the problem is, as anyone who has any experience with notice-and-comment rulemaking will know, publishing regulations has become a very slow endeavor.  Thus, although the monograph process started in 1972, many of the monographs are not yet final, and, more troublesome, FDA has not been able to respond quickly to safety concerns as new information about OTC drugs is learned. (See, e.g., Jake’s blog post from last year about the monograph covering antibacterial soap, and my discussion of the risk of liver injury associated with acetaminophen, the active agreement in Tylenol, in our Oct. 2013 podcast).

So how did we get where we are today?

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2014 CLB Workshop Mini-Podcasts

The first set of our mini-podcasts with the 2014 CLB Workshop speakers is up!  Listen to David Kaye (Penn State) discuss the 4th Amendment and DNA databases, Michelle Oberman (Santa Clara) discuss debates over abortion laws, Rebecca Dresser (Wash U) discuss incorporating subject perspectives into research ethics, and Dan Burk (UC Irvine) discuss the Supreme Court’s recent Myriad Genetics decision.

Pricing in the U.S. Health Care Financing System: An Anecdote (or Data Point)

Almost four weeks ago, I had a pretty serious pulmonary embolism – a blood clot partially blocking the artery that goes from the heart to the lungs.  (I’m fine, now, thanks, with no long-term harm except a likely need for life-long blood thinners.)  I walked 100 feet and suddenly found myself gasping as though I had tried to sprint 200 yards.  Even a serious denialist/”guy” like me knew that something was seriously wrong, and after quick consultation by phone with my doctor-wife, I hied me to an emergency room.  I’m a happy Kaiser Permanente member (and she’s a happy Kaiser Permanente doctor), but the nearest Kaiser ER was at least a 25-minute drive away, so she instructed me to go to the Stanford ER, about a mile away.

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Should We Care About the Moral Propriety of Cognitive Enhancement?

Roland Nadler

Scientific American recently published a short essay by Roy H. Hamilton and Jihad Zreik, asking whether we should use devices (like tDCS, part of a larger category of brain stimulation technologies that I and others have blogged about before) to make ourselves smarter. I enjoyed it, and in no small part because the analysis breaks down the potential moral issues with cognitive enhancement into four basic categories — safety, distributive justice, autonomy / coercion, and authenticity — that happen to match the “four cardinal concerns” identified in the major empirical study of public attitudes toward cognitive enhancement that I helped author. But in reading the essay, and in revisiting the first-order moral question about whether we ought to enhance, I also felt a twinge of skepticism about the undertaking.

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