David's New Book

Friday, March 26, 2010

IDSA 10, USA 0.

I thought that this would be an appropriate title for a blog during March Madness (which I do not follow at all).  I recently attended a Gordon Conference on New Antibacterial Discovery.  I saw lots of cool science and hot technology, but came away disappointed with how far we are stuck in the muck of political complacency, scientific denial and regulatory inertia. 

Bob Guidos (pronounced Gidos, not Gweedos) gave a nice presentation on the Infectious Diseases Society of America’s (IDSA) 10 by 20 initiative where they are pushing for 10 new antibiotics to be approved by 2020 for the treatment of infections caused by one or more of their ESKAPE organisms.  For a complete explanation of these resistant bacterial pathogens and their initiative, see their website at www.idsociety.org.  The crowd was generally critical because they felt that this goal of 10 new antibiotics by 2020 was unrealistic given the current status of antibiotic discovery and development.  I agree with that view.  Nevertheless, I applaud the IDSA for continuing to push this concept.  If nobody fights for new antibiotics, we will surely have none.  So, realistic or not – go for it IDSA!  What can I do to help?

During his talk, Bob noted some disturbing realities about our most important funding agency for our national basic science effort on antibiotics and antibiotic resistance, the NIH.  I noted in a previous blog that the NIH had recently established a new study section specifically to provide expert review of grant requests for studies on bacterial resistance and the discovery and development of new antibiotics called DDR.  I even participate from time to time. Bob showed an analysis carried out by the IDSA which demonstrated that the NIH spends between $9.7million and $38million of research directly in ESKAPE pathogens or in other pathogens but at least relevant to ESKAPE pathogens.  Great! You cry.  But wait – that comes to a paltry 0.03 – 0.13% of NIH’s total budget! 

So – earth to NIH – where are we going to train new investigators in antibiotic research?  How will academia contribute to the discovery of new antibiotics if we don’t fund the research?  Where are your priorities?  I know, they are where they have always been – in TB, malaria, biodefense and vaccines.  This is laudable – but not enough.

In response, the NIH says that they are offering an array of services from support for screening, toxicity testing and even early clinical trials.  I applaud this effort and await another audit to see how much they are dedicating resources to antibiotics and the ESKAPE organisms in this effort.

Of course, antibiotic discovery and development in academia does not have a stellar track record.  This is partly because much of the expertise required to drive this process forward lies within the pharmaceutical industry and academics are not trained in industry.  This is another area where NIH could help by providing training opportunities for academics within industry (that is, within the few companies left still doing antibiotic research).  Even if we can train folks in antibiotic development and discovery, we still need a way to bring these needed drugs to FDA approval and to the marketplace.  We now seem farther from achieving that goal than ever before.

Between the NIH with its chronic lack of support for antibiotic research and the FDA’s current position somewhere between confused and outright hostility to antibiotic development, I think the score is IDSA 10, USA 0.