The Fight Against Multidrug-Resistant Bacteria
Authors: Dalia Deak, John H. Powers, Kevin Outterson, Aaron S. Kesselheim
Journal: Annals of Internal Medicine (2017)

Letters3 January 2017The Fight Against Multidrug-Resistant BacteriaDalia Deak, MPH, John H. Powers, MD, Kevin Outterson, LLM, JD, and Aaron S. Kesselheim, MD, JD, MPHDalia Deak, MPHFrom Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; George Washington University School of Medicine, Washington, DC; School of Law, Boston University, Boston, Massachusetts; Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.Search for more papers by this author, John H. Powers, MDFrom Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; George Washington University School of Medicine, Washington, DC; School of Law, Boston University, Boston, Massachusetts; Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.Search for more papers by this author, Kevin Outterson, LLM, JDFrom Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; George Washington University School of Medicine, Washington, DC; School of Law, Boston University, Boston, Massachusetts; Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.Search for more papers by this author, and Aaron S. Kesselheim, MD, JD, MPHFrom Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; George Washington University School of Medicine, Washington, DC; School of Law, Boston University, Boston, Massachusetts; Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/L16-0582 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE:We agree with Drs. Weinrauch and D'Elia's call for greater emphasis on making currently available products more effective through host modulation and improvements in stewardship. Although we do not have specific insight into the potentiator role of calcium-channel blockers, we believe that funders should prioritize limited resources by supporting investigations of scientifically plausible and cost-effective interventions.Of course, resistance can develop even when antibiotics are optimally used, necessitating a vibrant antibiotic pipeline. We agree with Dr. Boucher and colleagues that noninferiority designs for such products can benefit patients. However, we believe that recognizing the limits of these trials ...References1. Prasad P, Sun J, Danner RL, Natanson C. Excess deaths associated with tigecycline after approval based on noninferiority trials. Clin Infect Dis. 2012;54:1699-709. [PMID: 22467668] doi:10.1093/cid/cis270 CrossrefMedlineGoogle Scholar2. Fleming TR, Powers JH. Issues in noninferiority trials: the evidence in community-acquired pneumonia. Clin Infect Dis. 2008;47 Suppl 3:S108-20. [PMID: 18986275] doi:10.1086/591390 CrossrefMedlineGoogle Scholar3. U.S. Food and Drug Administration. Facilitating antibiotic drug development for patients with unmet need and developing antibacterial drugs that target a single species. 9 August 2016. Accessed at www.fda.gov/Drugs/NewsEvents/ucm497650.htm on 21 November 2016. Google Scholar4. Larsen J. BARDA's market research for a clinical trial network for antibiotics. 18 July 2016. Accessed at www.fda.gov/downloads/Drugs/NewsEvents/UCM511717.pdf on 21 November 2016. Google Scholar Author, Article, and Disclosure InformationAffiliations: From Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; George Washington University School of Medicine, Washington, DC; School of Law, Boston University, Boston, Massachusetts; Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.Grant Support: Dr. Kesselheim is supported by the Greenwall Faculty Scholars in Bioethics Program, the Laura and John Arnold Foundation, and the Harvard Program in Therapeutic Science.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-0291. 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 Helen W. Boucher , Sara E. Cosgrove , Edward Cox , and George H. Talbot Metrics 3 January 2017Volume 166, Issue 1Page: 79KeywordsAntibioticsBacteriaBioethicsClinical trialsDiagnostic techniquesDisclosureDrugsForecastingMultidrug resistancePathogens ePublished: 3 January 2017 Issue Published: 3 January 2017 Copyright & PermissionsCopyright © 2017 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...