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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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Latest CLB Podcast!

CLB Podcast Listeners: Our November 2013 podcast is (finally) up!  In this edition, we discuss the Oklahoma statute prohibiting the off-label use of “abortion-inducing drugs” (and the related litigation), insurance coverage for conceiving a “savior sibling,” and patents and non-invasive pre-natal genetic testing.  Enjoy!

Monsanto’s Soybean Future?

Malia McPherson, SLS class of 2016

Big things are happening in St. Louis, Missouri, home to controversial, agriculture giant Monsanto. This year, the last Monsanto-owned patent for their blockbuster Roundup Ready® trait in soybeans is set to expire. The last applicable third-party patent for the trait will also expire in early 2015. While the effects of this legal change are speculative at best, farmers are looking forward to cheaper “generic” GMO soybeans and a return to seed-saving (the traditional way to replant crops rather than re-buying seed each year as required in Monsanto contracts). Farmers that export these crops, however, have only until 2021 to switch to Genuity® Roundup Ready 2 Yield® seeds, when Monsanto will no longer support the regulatory packages required for international sale (explained here).

While the Supreme Court upheld the enforcement of these patents last year in Monsanto Co. v. Vernon Bowman, public backlash against their products and environmental impact may be pushing Monsanto into a new field (no pun intended). In December, the company announced the start to a long-term strategic partnership with Danish company Novozymes, creating “The BigAg Alliance” aimed at microbial discovery and innovation. The press release, along with this nice chart, suggests that the alliance will work towards research, development, and commercial capabilities to create sustainable biological solutions in agriculture. It is an interesting move for Monsanto and perhaps an optimistic use of the word “sustainable.” But this venture brings to mind many questions about the way in which these two companies aim to innovate and profit from microbes.

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Neuroscience, Neuroethics, and Advertising

Roland Nadler

One of my favorite regular columns is The Ethicist over at the New York Times. I am not entirely sure whether my rate of agreement with the recommendations has increased or decreased since Chuck Klosterman took over the post, but then, part of what makes me eager to read the column is that it is routinely just as stimulating to read it and disagree. Now, maybe I am peculiar in that regard — after all, it gives me an opportunity to think, “if I were the Ethicist …” and I suppose I do kind of relish imagining having the job. But at any rate, when Klosterman in today’s column missed what I felt was an important and useful angle in his response to a question about the ethics of advertising, I was hardly disappointed — mostly I was just glad for the prompt to piece together my own thoughts.

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FDA Approves Drugs Based on Clinical Trial Data of Varied Quality? Yes, Of Course It Does.

For those interested in the FDA approval process (and who isn’t!), the Jan. 22/29 issue of JAMA contains a worthwhile set of articles.  Downing et al’s article, “Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012,” in particular, has gained attention (from, for example, the Wall Street Journal and Forbes).  The article describes a study of the clinical trial evidence supporting FDA drug approvals, and the authors conclude that the quality of that clinical trial evidence “varie[s] widely.”  As someone who used to work at FDA, this result strikes me as utterly unsurprising (and I imagine many FDA lawyers and scholars had the same reaction).

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Biosci Fi: Brendan Sanderson’s Mistborn – Alomancy As Welfare

Guest Poster, Prof. Ryan Calo, former director of the SLS Center for Internet and Society

When the popular fantasy writer Robert Jordan died in 2007, his estate handpicked Brendan Sanderson to help finish Jordan’s epic Wheel of Time series.  I thought Sanderson did a lovely job on the final books and decided to read one of his previous novels, Mistborn: The Final Empire.  It turns out that Sanderson’s tale of inequality, though in respects overdone, enjoys strange and unexpected parallels to ongoing research into the bioscience of class.

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The World vs. Myriad('s Patents' Validity)

In the latest salvo in Myriad Genetic’s bloody patent disputes with its BRCA-testing competitors, Myriad has sued LabCorp after the company announced it was to begin offering its own BRCA-testing product, BRCAssure. This brings to six the total number of companies held at the point of Myriad’s bayonet: Ambry Genetics, Gene-by-Gene, Quest, GeneDx, Invitae, and now, LabCorp. With the threat of these lawsuits, a purely commodified BRCA-testing market is not coming online any time soon.

From a purely patent law perspective, Myriad has several pretty good claims. Out of the patents in play in its loss before the Supreme Court earlier this year, Myriad still retains a number of valid claims: claims directed to BRCA cDNA and primers and probes used for BRCA sequencing, generally. In addition, Myriad has since acquired a number of new patents that have yet to be touched by any federal court. In both of these cases, Myriad’s competitors will need to prove by “clear and convincing evidence” that those claims are invalid–a particularly high bar.

Nonetheless, I think Myriad’s “scorched earth” litigation policy is suicidal. Why? For two, interrelated reasons: (1) because of a rule the Supreme Court established over forty years ago in a case called Blonder-Tongue Labs., Inc. v. University of Illinois; and (2) because of the current composition of the lower appellate court, the Federal Circuit. I’ll briefly explain both and then talk about how they come together to augur poorly for Myriad. Read the rest of this entry »