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.
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.
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!
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.
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.
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).
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.
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 »
And it’s not the California Court of Appeals for the First District, the lower court in People v. Buza.
In People v. Lowe, the California Court of Appeals for the Fourth District, Division One (the “Inland Empire”), had upheld against a Fourth Amendment claim a conviction based in part on DNA identification stemming from a sample taken from an arrestee. The California Supreme Court granted and then, after the U.S. Supreme Court’s decision in Maryland v. King, sent it back to the lower court for reconsideration in light of that case. (It did the same with People v. Buza, which had gotten more attention because there the lower court had held the DNA provisions violated the federal constitution.)