Will the FDA Regulate Just Genetic Risk Data, or All Risk Data?

The latest in the 23andme versus FDA saga, in which the FDA halted 23andme from offering health-risk analyses of the genotyping service the company sells, comes in a commentary published yesterday in Nature. The commentary’s authors, Robert Green of Harvard Medical School and Nita Farahany of Duke Law School, address a key question raised by the FDA’s […]

Continue reading →

Is The National Cancer Institute Telling Me to Remove My Breasts?

One of the key issues in the dust-up over the FDA’s insistence on regulating 23andMe’s service  is the question of how 23andMe’s health-risk results differ from other forms of health-risk information. Today, geneticist Joe Pickrell offers a sharp post that unpacks this a bit. He asks Should the FDA regulate the interpretation of traditional epidemiology? It’s a damned good question. Many online […]

Continue reading →

What Does the FDA Want From 23andMe?

Here’s a particularly sharp, context-rich post on that question from  from Margaret Curnutte, currently of Baylor University. It seems one of the more deeply informed takes on this fracas. A couple of the key points: On what 23andMe was offering: From its inception, [23andMe] has treaded a fine line between claiming to provide something that […]

Continue reading →

Change at the FDA One Can Believe in (versus feel-good morale builders)

This post by Science’s Jennifer Couzin at ScienceInsider suggests how much serious overhaul the FDA needs. Looks like some scientists at the Food and Drug Administration are doing what they can to influence president elect Obama’s choice of their new boss. Nine scientists have written to Obama’s transition team pleading with him to restructure the […]

Continue reading →