Sunday, August 19, 2007

Quick hits - the pharmacogenomics of Warfarin, and the statistical analysis of TGN1412

1. Terra Sigillata explains the pharmacogenomics of warfarin far better than I can.

2. Andrew Gelman discusses the statistical analysis of TGN1412, a clinical trial that resulted in a cytokine storm (which lead to multiple organ failure, cancer, gangrene, and amputation) for six very unfortunate volunteers and caused the fledgling biopharmaceutical company TeGenero to go bankrupt. I don't think anyone ever thought of doing a statistical analysis of the trial, simply because it was unnecessary. As it turns out, if you do a classical statistical analysis on the data, you get a result that isn't statistically significant! Basing a scientific conclusion on such an analysis is clearly absurd, and serves to highlight the limitations of statistics, or, rather, the way we think about and use statistics. The crux of the matter is that the adverse effects would have been significant if even one person had experienced a cytokine storm. Frequentist statistics can't pick up on that assumption, and Bayesian statistics would probably require an otherwise absurd prior to pick it up.

I guess there's a lot going on with statistics this week.