The Fight Against Multidrug-Resistant Bacteria
Authors: Helen W. Boucher, Sara E. Cosgrove, Edward Cox, George H. Talbot
Journal: Annals of Internal Medicine (2017)

Letters3 January 2017The Fight Against Multidrug-Resistant BacteriaHelen W. Boucher, MD, Sara E. Cosgrove, MD, Edward Cox, MD, and George H. Talbot, MD, BAHelen W. Boucher, MDFrom Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts; Johns Hopkins University School of Medicine, Baltimore, Maryland; U.S. Food and Drug Administration, Silver Spring, Maryland; Talbot Advisors, Anna Maria, Florida.Search for more papers by this author, Sara E. Cosgrove, MDFrom Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts; Johns Hopkins University School of Medicine, Baltimore, Maryland; U.S. Food and Drug Administration, Silver Spring, Maryland; Talbot Advisors, Anna Maria, Florida.Search for more papers by this author, Edward Cox, MDFrom Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts; Johns Hopkins University School of Medicine, Baltimore, Maryland; U.S. Food and Drug Administration, Silver Spring, Maryland; Talbot Advisors, Anna Maria, Florida.Search for more papers by this author, and George H. Talbot, MD, BAFrom Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts; Johns Hopkins University School of Medicine, Baltimore, Maryland; U.S. Food and Drug Administration, Silver Spring, Maryland; Talbot Advisors, Anna Maria, Florida.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/L16-0584 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:Deak and colleagues (1) raise doubts about the value of recent FDA-approved antibiotics. To the contrary, these approvals—enabled by innovative study design and regulatory guidance—represent meaningful progress for patients and public health through restoration of evidence-based, feasible antibacterial drug development. Asserting that antibacterial drug development should require “demonstrated superiority” represents a fundamental misunderstanding of societal and drug development issues. Superiority designs require delaying development until resistant bacteria are highly prevalent, a time when substantial patient harm has occurred.Since 2010, the FDA has approved 6 of the 10 systemically available antibiotics highlighted in the Infectious Diseases Society ...References1. Deak D, Outterson K, Powers JH, Kesselheim AS. Progress in the fight against multidrug-resistant bacteria? A review of U.S. Food and Drug Administration-approved antibiotics, 2010-2015. Ann Intern Med. 2016;165:363-72. [PMID: 27239977]. doi:10.7326/M16-0291 LinkGoogle Scholar2. Boucher HW, Talbot GH, Benjamin DK, Bradley J, Guidos RJ, Jones RN, et al; Infectious Diseases Society of America. 10 x ‘20 Progress—development of new drugs active against gram-negative bacilli: an update from the Infectious Diseases Society of America. Clin Infect Dis. 2013;56:1685-94. [PMID: 23599308] doi:10.1093/cid/cit152 CrossrefMedlineGoogle Scholar3. Talbot GH, Powers JH, Fleming TR, Siuciak JA, Bradley J, Boucher H; CABP-ABSSSI Project Team. Progress on developing endpoints for registrational clinical trials of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections: update from the Biomarkers Consortium of the Foundation for the National Institutes of Health. Clin Infect Dis. 2012;55:1114-21. [PMID: 22744885] MedlineGoogle Scholar4. Nambiar S, Laessig K, Toerner J, Farley J, Cox E. Antibacterial drug development: challenges, recent developments, and future considerations. Clin Pharmacol Ther. 2014;96:147-9. [PMID: 25056394] doi:10.1038/clpt.2014.116 CrossrefMedlineGoogle Scholar5. Rex JH, Eisenstein BI, Alder J, Goldberger M, Meyer R, Dane A, et al. A comprehensive regulatory framework to address the unmet need for new antibacterial treatments. Lancet Infect Dis. 2013;13:269-75. [PMID: 23332713] doi:10.1016/S1473-3099(12)70293-1 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts; Johns Hopkins University School of Medicine, Baltimore, Maryland; U.S. Food and Drug Administration, Silver Spring, Maryland; Talbot Advisors, Anna Maria, Florida.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=L16-0584. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoProgress in the Fight Against Multidrug-Resistant Bacteria? A Review of U.S. Food and Drug Administration–Approved Antibiotics, 2010–2015 Dalia Deak , Kevin Outterson , John H. Powers , and Aaron S. Kesselheim The Fight Against Multidrug-Resistant Bacteria Larry A. Weinrauch and John A. D'Elia The Fight Against Multidrug-Resistant Bacteria Dalia Deak , John H. Powers , Kevin Outterson , and Aaron S. Kesselheim Metrics Cited byComparative genomics analysis of the multidrug-resistant Aeromonas hydrophila MX16A providing insights into antibiotic resistance genesSuperbug Clinical Trials 3 January 2017Volume 166, Issue 1Page: 78-79KeywordsAntibioticsBacteriaBacterial pneumoniaDisclosureDrugsFood and Drug AdministrationPathogensPrevention, policy, and public healthSkin infectionsUrinary tract infections ePublished: 3 January 2017 Issue Published: 3 January 2017 Copyright & PermissionsCopyright © 2017 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...