Dear All: Two things today. Unrelated, but both relevant!
WHO's GLASS: WHO's Global Antimicrobial Resistance Surveillance System (GLASS) was created during October 2015 and seeks to obtain coordinated and consistent global estimates on resistance rates. In a major report released on 29 Jan 2018, GLASS now provides provides official national AMR data for the period 2016-17 from 40 countries based on testing of 507,746 isolates of Acinetobacter spp., Escherichia coli, Klebsiella pneumoniae, Neisseria gonorrhoeae, Salmonella spp., Shigella spp., Staphylococcus aureus, and Streptococcus pneumoniae. Participating countries span the globe:
The good news is that GLASS exists and that countries are making progress on creating National Coordination Centres (NCCs), National Reference Laboratories (NRLs), and sentinel surveillance sites. Progress is (no surprise) somewhat uneven, but the real point is that progress is happening.
The bad news is that substantial rates of resistance are seen world-wide. There is no single best way to summarize this, but here is an example of a resistance rate summary that you can find in the report (x-axis is % non-susceptible). Note the nearly 25% rate of imipenem resistance!
FDA & PDUFA VI: FDA posted a small business-focused analysis of PDUFA VI back in November 2017 that I only recently learned about. As a reminder, the Prescription Drug User Fee Act (PDUFA) has been an evolving legislative series by which FDA collects fees that it then uses to make the drug review process more efficient while not compromising drug safety. There are many changes in PDUFA VI (please see the full summary here), but these are notable to my eye:
And, this sheds some light on the recently announced Duke-Margolis 1-day workshop on inclusion and exclusion criteria in clinical trials on 16 April 2018 as part of a cooperative agreement with FDA (corresponding FR notice) which will "discuss a variety of topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to facilitate the enrollment of a diverse patient population."
It all makes your head spin! Although we don't know the pace with which all this will happen, it certainly reminds me of Picabia's comment that "Our heads are round so our thoughts can change direction."
Buckle up! --jr
John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: http://amr.solutions/blog-index.html
Upcoming meetings of interest to the AMR community: