Biotech Values

[biomaven0]

If the statisticians at the FDA have their way, in a few years all antibiotic research will pretty much grind to a halt. It's not just their ever-changing non-inferiority standards - it's what happens if standards are written by people completely out of touch with the real world.

A good example is the FDA requiring fever resolution as an endpoint in skin and soft tissue trials (ABSSSI). They apparently came up with this by looking at trials from 70 years ago, ignoring the fact that the vast majority (maybe 85%) of patients with these infections today do not present with fever at all. I recently had dinner with someone who is perhaps the best-known expert in the US on antibiotic resistance and he was spitting blood at the FDA guidance and ever-changing goalposts.

Here's a good discussion of the non-inferiority mess:

http://antibiotics-theperfectstorm.blogspot.com/2010_08_01_archive.html

(There are other good posts on this blog).