Antibiotics are a crucial aspect of modern medicine, and this fall has been filled with a number of hugely troubling reports about how we’re moving closer to an era where we can no longer take them for granted. About a month ago, the associate director of the CDC told PBS in an interview that “We’ve reached the end of antibiotics.” Frankly, this is terrifying.
There are lethal bacteria which are resistant to all known antibiotics. Among enterobacteria, the genetic ability to defeat the carbepenem family of antibiotics, a set of antibiotics of last resort, has been spreading. Traditional methods of trying to prevent this spread, including even very tight international borders, have gaps; New Zealand (one of the most careful nations in this respect, with obvious natural advantages from its isolation) has recently announced its first case, and first death, of a citizen from totally antibiotic-resistant bacterial infection.
A great description–and frightening prediction–of the rise of antibiotic-resistant bacteria was just published by Maryn McKenna. For a significantly more detailed look, the CDC published its first report on the topic in September. Over two million people a year get antibiotic-resistant infections, and over 23,000 die as a result.
In addition to the horror of untreatable infections, the loss of usable antibiotics threatens everything from cancer treatment to transplantation surgery—really any medical technologies that rely on immunosuppressants or which increase the risk of microbes entering the body. And our current food supply relies heavily on antibiotics—though that reliance is both threatened by and likely at least a partial cause of the rise of antibiotic-resistant bacteria.
Among approaches like trying to maintain the efficacy of the antibiotics we currently have (like FDA’s (unfortunately voluntary) strategy on reducing antibiotic use in agriculture), more antibiotics need to be developed. In July 2012, Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA), which included some provisions creating new incentives for pharmaceutical companies to develop new antibiotics (principally the possibility of fast-track review and 5 years of additional regulatory market exclusivity for new antibiotics (pdf description here)). The full set of potential policy tools is a big one, but it looks for now like there’s very little in the pipeline. Aaron Kesselheim and Kevin Outterson have a great piece on firm incentives here; among other things, they point out that there’s a huge gap between private and social value from new antibiotics. Firms simply can’t capture much of the social value, and so they don’t invest enough. FDASIA takes some steps in that direction, but will it be enough? (Seriously – does anyone with drug industry connections know whether this is making a difference?) What else should we be doing to increase innovation in developing new antibiotics? And given that Congress appears largely incapable of legislative action, are there ways to drive that innovation without new legislation?
Venture capital for antibiotic startups is sparse because clinical trials are generally too expensive to run without big pharma collaboration. The feds need to (1) provide funding for qualified startups, hopefully in collaboration with venture capitalists; (2) provide funds to qualified pharmas and/or CROs for performing clinical trials; (3) form and fund academic consortia targeted at devising new drugs that act through mechanisms likely to escape antibiotic resistance.