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).
Our latest mini-podcast is up! Listen to Prof. Francis Shen (Minnesota) discuss neuropolitics with CLB’s Hank Greely.
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.
CLB’s latest mini-podcast is up! Listen to Jill Horwitz (UCLA) discuss workplace wellness programs with CLB’s Hank Greely.
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?
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.
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.