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.
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.
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 . 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?
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.
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?