David's New Book

Friday, May 10, 2013

Who Will Do This?


The National Institutes of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) in the US is now very aware of the crisis of antibiotic resistance and the lack of new antibiotics in the pipeline to address this public health threat.  This was not always the case.  As I wrote in my book, a number of us carried out a study back in the 1980s showing at least a 30-year neglect of antibiotics research at NIH.  Things did not turn around there until 2006.

NIH now offers grants to support early research going up through phase I development and beyond in many cases.  They also offer a variety of service resources such as manufacturing, toxicological testing, in vitro testing including simple bacterial screening and surveillance, animal efficacy studies and PK/PD studies through contract laboratories supported by NIAID. For these resources, which are offered free of charge to the investigator, you do not have to be an NIH investigator and it is not even clear that you have to be located in the US.  You do, I suppose, have to have something worth testing. For further information – check out this and related links - http://www.niaid.nih.gov/labsandresources/resources/translational/pages/default.aspx.

Although this is more than laudable on the part of NIAID, there is a major problem here. Even though the NIAID says they support antibiotic research, a funding line of 6% (the payline for NIAID over the last year or so) means that they hardly fund any research at all.  Without the early basic research, we will never have products coming out of academia that might be eligible for the translational resources offered by NIAID.

On top of this, I am becoming extremely discouraged about the ability of our researchers to even enter the area of antibiotic discovery and preclinical development. I’ve spent some time over the last several months visiting academic centers and speaking with colleagues in academia on anti-infective research.  Although I am incredibly impressed with the level of motivation and the innovative approaches being taken in academia, I am equally impressed with the lack of real ability to understand what one can reasonably pursue and how to pursue it. There is also a lack of clinical understanding in many departments coupled with an absence of translational expertise that would allow projects to either move forward or be terminated (appropriately) early. In a situation where grant funding is extremely competitive like it is today, I fear for our ability to discover and develop needed new antibiotics in academia. 

When I think about those in academia today who actually have the skills necessary to discover new antibiotics and bring them forward, they are almost all that rare person who has left an industry career and gone into academia from there.  I can count these folks working on antibiotic discovery (that I know) on one hand.

But with the continuing demise of antibiotic discovery in pharmaceutical companies – both large and small – we desperately need this research to come from somewhere else.  Where?  Academia has to be part of the solution.  To this end, NIH must take a much more proactive role in getting our academic investigators appropriately trained in antibiotic discovery and development.  They have told me that they are doing this – but I personally see no evidence of it.

In addition, NIH must find a way to increase their funding for this research.  Of course, it makes no sense to fund investigators who are not capable of doing the work. So NIH must do both things.  They must fund training and work to assure that appropriately trained investigators get deserving projects funded.  This might mean that, for a change, antibiotics gets monies that might have otherwise been spent on HIV or HCV or vaccines or pathogenesis.  After all the years of NIH neglect, they certainly owe the American public, the world and antibiotics investigators this much.