Superbug crisis shows progress in antibiotic development “alarmingly elusive”

patients can take to preserve the life-saving power of antibiotics by limiting their inappropriate use.

IDSA leaders have been exploring with other stakeholders specific solutions to address the pipeline problem including the creation of a Limited Population Antibacterial Drug(LPAD) approval pathway to speed drugs to approval as well as new R&D tax credits and reimbursement models. Congressional Republican leaders in the U.S. House of Representatives announced last monththeir intent to make fixing the antibiotic R&D pipeline a priority for the 113th Congress.

The release notes that ironically, at this urgent time of greatest need, the number of pharmaceutical companies investing in antibiotic R&D has plummeted. Pharmaceutical companies typically put R&D resources into the development of chronic disease drugs — including those to treat high cholesterol, diabetes, and cancer — which provide significant financial rewards, partly because they are intended to be taken for long periods of time.

Antibiotics, which are intended to be taken for short courses, just can’t compete. The results are playing out in real time, with the smaller pharmaceutical company Polymedix — which has one of the seven drugs in development noted in the 10 x ’20 paper — filing for bankruptcy protection in early April 2013. Moreover, the policy update reports that only four large multinational companies remain in antibiotic R&D. One of these, AstraZeneca, which has two of the seven drugs in development, plans to reduce its future investments in antibiotics, its CEO, Pascal Soriot, recently announced. The current pipeline of antibiotics is fragile indeed, and the dwindling roster of antibiotic developers has dire consequences for public health, patient care and national security.

New antibiotics are critically necessary to save the lives of people such as Josh Nahum, a healthy 27-year-old man who died from an overwhelming Enterobacter aerogenes infection as he was recovering in the hospital after a skydiving accident. Although his doctors tried desperately to save Josh, they ran out of antibiotics to treat this virulent bug. Read more about Josh’s storyand the experiences of others whose lives have been devastated by antibiotic resistance.

IDSA first warned of the looming antibiotic apocalypse with its 2004 report, “Bad Bugs, No Drugs” (PDF).

Nearly fifty other medical societies and organizations, including the American Medical Association, have endorsed the 10 x ’20 initiative so far.

IDSA is committed to ensuring proper use of currently-available antibiotics to make certain we can continue to count on them. But that is not enough. Simply put, the antibiotic pipeline is on life support and novel solutions are required to resuscitate it — now,” said IDSA President David A. Relman, MD. “In the past year, the heads of CDC and the World Health Organization, along with the United Kingdom’s chief medical officer, have all sounded the alarm about rising rates of antibiotic resistance. The lack of new antibiotics to treat these potentially life-threatening infections signals the end of modern medicine as we know it.”

The policy update, which appeared in the 15 May issue of Clinical Infectious Diseases(CID), is available online.

The release notes that although the paper published in CID recognizes two drugs approved by the FDA since 2009, the 10 x ’20 Initiative was launched in April 2010 following the approval of one of these drugs.

— Read more in Helen W. Boucher et al., “10 × ‘20 Progress — Development of New Drugs Active against Gram-Negative Bacilli: An Update From the Infectious Diseases Society of America,” Clinical Infectious Disease(17 April 2013) (doi: 10.1093/cid/cit152)