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ESKAPE continues to escape
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Infection is a challenging and frequently devastating complication of orthopedic procedures. As antibiotic resistance continues to increase, especially through the widespread use of antibiotic loaded biomaterials and other mechanisms, the morbidity and mortality associated with the infecting organisms will increasingly become problematic. This health care crisis is so worrisome that the WHO has identified antimicrobial resistance as one of the three greatest threats to human health. A task force charged by the British government to look into this issue also identified emergence of antibiotic resistance as an extremely worrisome problem for the future, when the lives of 15 million people may be at jeopardy.
Timothy L. Tan
Javad Parvizi
Despite the emergence of the ESKAPE organisms (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacter species), which can “escape” currently available antibiotics in our arsenal, the pipeline of novel antibiotics to treat these resistant organisms has diminished. This is largely due to pharmaceutical companies removing themselves from the antibiotic industry because of the low returns for the vast research and development budget that needs to be assigned to development of novel antibiotics, and the rigorous and often unpredictable approval process set out by the FDA.
In an effort to stimulate the research and development of new and more robust antibiotics, the International Disease Society of America (IDSA) has launched the 10×’20 initiative. The new initiative endeavors to develop 10 new system antibacterial drugs by 2020 through the creation of a sustainable, global research and development enterprise to unlock new drug classes and expand on existing ones. In addition to the 10x’20 initiative, the FDA has created the Antibacterial Drug Development Task Force and passed the Generating Antibiotics Incentives Now Act, which facilitates the approval process through priority review and extends market exclusivity.
The IDSA initiative may be working. Last year alone, four novel antibiotics were FDA approved: tedizolid (Sivextro, Cubist Pharmaceuticals; Lexington, Mass.) and dalbanancin (Dalvance, Durata Therapeutics Inc.; Chicago) for treating methicillin-resistant S. aureus (MRSA), ceftozolane (Zerbaxa; Cubist Pharmaceuticals Inc.; Lexington, Mass.) for complicated urinary tract and abdominal infections, and oritavancin (Orbactiv; The Medicines Company; Parsippany, NJ) for Gram-positive skin infections. While the development of these drugs is encouraging, many of the superbugs, particularly Gram-negative organisms, are still left uncovered. It appears that despite some strides being made, more challenges remain. Moving forward, all of us need to exercise antibiotic stewardship that may impact the emergence of resistant organisms.
References:
Administration USFaD. New FDA task force will support innovation in antibacterial drug development. 2012.
Campoccia D, et al. Biomaterials. 2010;doi: 10.1016/j.biomaterials.2010.05.005.
Infectious Diseases Society of America. Clin Infect Dis. 2010;doi: 10.1086/652237.
O’Neill J. Review on Antimicrobial Resistance. Antimicrobial Resistance: Tackling a crisis for the health and wealth of nations. London. 2014.
Organization WH. Antimicrobial resistance: A global report on surveillance. 2014.
For more information:
Timothy L. Tan, MD, can be reached at Clinical Research Department at Rothman Institute, Thomas Jefferson University, 125 South 9th St., Suite 1000, Philadelphia, PA 19107; email: timtan00@gmail.com.
Javad Parvizi, MD, FRCS, can be reached at the Rothman Institute, 925 Chestnut St., 5th Fl., Philadelphia, PA. 19107; email: parvj@aol.com.
Disclosures: Tan reports no relevant financial disclosures. Parvizi is a consultant to Zimmer, Smith & Nephew, 3M and Convatec.