If you are looking for someone who is perfectly suited to interact with, provide guidance to, or simply scream at the FDA regarding their disastrous policies for clinical trials of new antibiotics that have put all of us as risk look no further than Dr. Shlaes first Science 2.0 piece.
Dr. Shlaes, the former VP of infectious disease research at Wyeth, has been running a website called Antibiotics the perfect storm, in which he has chronicled his long-running battle with the FDA. The struggle began when Shlaes ran into multiple brick walls while trying to get approval for a new antibiotic Tygacil (which was discovered by ACSH s Dr. Josh Bloom s group in 1992, but not approved until 2005).
At that time, the FDA changed its clinical trial requirements, making clinical trials for antibiotics virtually impossible to conduct. It was not until last year that the FDA without admitting their mistakes undertook an initiative to reboot the way it dealt with antibiotic clinical trials. Although they are now coming to their senses, the 10+ year period during which they were anything but sensical is possibly the major reason we are facing this crisis now.
Some highlights from his Science 2.0 piece include:
Regarding using death as an endpoint rather than clinical response to determine the efficacy of new antibiotics:
My belief, in addition to the problem of feasibility using mortality as an endpoint, is that it is confounded. That is, many of the deaths seen in such trials are due to comorbidities and not infection. How many of the deaths we see in such trials are we talking about?
And:
An editorial in the New York Times noted that we need to provide incentives to get companies back into the antibiotic R&D game to continue to have antibiotics active against resistant pathogens. We also need realistic regulatory pathways.
You can read Dr. Shlaes full article here.