We are fighting a losing battle. While the opposition grows smarter and stronger, we remain stuck in the past with outdated and increasingly ineffective weapons. Bacteria are becoming alarmingly more drug-resistant, and there are no effective innovations in sight. Moreover, these dangerous infections occur in hospitals, the very place that is supposed to treat us for our diseases.
The Centers for Disease Control and Prevention (CDC) recently issued a report stating that Carbapenem-Resistant Enterobacteriaceae (CRE) has been steadily increasing over the past decade. Invasive CRE infections are associated with cause of death in up to 50 percent of infected patients. Numerous studies have depicted the significant increases of multi-drug resistant strains of bacteria, especially in hospitals.
The World Health Organization (WHO) has listed antimicrobial resistance as one of the three greatest threats to human health. The prevention of transmission in hospitals is currently under scrutiny and gaining attention. Medicare/Medicaid recently changed its policy and no longer pays for hospital-acquired conditions, including infections, forcing hospitals to foot the bill.
While preventing the spread of these infections is important, the ability for us to fight these infections is of critical need. Since 1962, only two new classes of antibiotics have reached the market, a drastic decline from the many new classes that were introduced from 1940 to 1962. In a review of antibiotics currently under development, there are only two new antibiotics in Phase I of clinical trials and none in Phase II or III.
In 2010, the Infectious Disease Society of America (IDSA) created the 10 x 20 Initiative, which is designed to empower the research and development of "10 new, safe and effective antibiotics by 2020." IDSA recommends focusing new antibiotics to fight the "ESKAPE" pathogens, which are responsible for the majority of hospital infections in the United States. However, this has received no legislative support. As of 2012, the antibiotic development market is still stagnant, and we are now seeing pan-drug-resistant bacteria which are resistant to all antibiotics.
So if the 'enemy' is getting smarter and stronger, why are we not creating better weapons to fight?
Scientifically, it is now harder to develop new drugs than it was in the past. As each new class of antibiotic is created, the next antibiotic becomes more complex, expensive and time-consuming to develop.
Economics also plays a large role: antibiotics have a poor return on the investment necessary to develop these drugs. Finally, the regulation on antibiotic approval through the FDA has become more confusing, and there is no legislative support to incentivize this field of research.
Specifically, current FDA regulation approves antibacterials one disease at a time, instead of based on the pathogen it is designed to fight.
For instance, K. pneumoniae can cause urinary tract, bloodstream, respiratory and surgical site infections; however, antibiotics are approved for one infection site, then clinical trials must be repeated in order to approve the antibiotic for additional site infections.
Until changes can be made, it is imperative that we treat antibiotics as a limited resource by limiting the use of antibiotics to cases where it is necessary to treat and putting more time, effort and value into developing new antibiotics and treatment measures.
Paula Strassle is a first-year Masters in Public Health student at the Rollins School of Public Health from Doylestown, Pa.
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