GLG News by Biostatisticians

The Chairman of Eli Lilly announcing that personalized medicine (e.g., pharmacogenetics) is a major shift in strategy for big pharma could impact in a significant way the market share for new drugs and the amount of money for research needed to bring a targeted therapy to market. If this strategy is...

In this meta-analysis, the authors looked at the number of studies, if any, per new drug application with the FDA that got published, at what time, and how much information they released. They concluded that there is strong evidence of publication bias in what the drug companies will make public, with...

Biodel’s September 8th announcement of the Phase III non-inferiority trial results for VIAject at the 44th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Rome left many investors wary of the legitimacy of the data that was presented. The study, which was originally conducted...

An August 2008 study analyzing the National Ambulatory Medical Care Survey (NAMCA) database shows a significant decrease in the amount of psychotherapy that psychiatrists are providing for their patients, while at the same time possibly showing an increase in medications prescribed. This correlation...

Slowing the progression of Alzheimer's disease by attacking tau tangles is a novel idea that should be considered a viable treatment alternative, especially in light of the failings of some recent beta-amyloid treatment strategies (e.g., Flurizan).   At the 2008 International Conference on...

The authors of this NEJM Special Report define subgroup analysis as “any evaluation of treatment effects for a specific end point in subgroups of patients defined by baseline characteristics.” When done appropriately, subgroup analysis are valuable. However, when done post hoc they can lead to incorrect...

Market impact is huge for many reasons. First, carvedilol is postulated to be a more effective beta blocker in the management of CHF with reduced ejection fraction compared to other generics and name brand ones on the market. This is based on a number of clinical trials demonstrating superiority in...

Because bone void fillers are approved as devices, not drugs, they do not need to demonstrate efficacy, just safety.   Orthopaedic surgeons are looking past bone void fillers to products that are more biologically active. 

- Smith and Nephew's patent on intramedullary hip screws was upheld.- However, it is difficult to enforce and Synthes has not taken any products off of the market. 

This article speculates that hip resurfacing will increase in popularity.  Because traditional total hip arthroplasty is predictable, reliable, and safe, hip resurfacing will not capture more than 4-5% of the THA market.