Monday, May 27, 2019
Innovation - response to comment
Google blogger no longer allows me to respond to comments in my own blog. I am obliged to respond, if needed, in a separate blog . . . .Progress!
I wanted to respond to the anonymous correspondent to my previous blog who suggested that the recently approved antibiotics were just incremental improvements over previous drugs and therefore that they deserved the market response they achieved.
Incremental, apparently, is in the eye of the beholder. During my early years as an infectious diseases physician, a new B-lactam (but a B-lactam nevertheless) was undergoing phase 3 clinical trials. My surgical intensive care unit was closed because of an outbreak of Gram-negative (Serratia) infection resistant to all marketed antibiotics except colistin. I was able to procure this new B-lactam (imipenem) under a compassionate use program at Merck. It was miraculous and saved lives that would have otherwise been lost. But it was just another B-lactam – or was it? Is a new B-lactam-B-lactamase inhibitor combination active against KPC-bearing carbapenem-resistant Gram negative pathogens incremental? Is a non-B-lactam B-lactamase inhibitor not innovative? I would also note that the most innovative antibacterial compounds and strategies will be the most challenging to develop from both a regulatory and a commercial point of view (see this link).