Ensuring Sustainability of Needed Antibiotics: Aiming for the DART Board
Authors: Brad Spellberg, Travis B. Nielsen, David N. Gilbert, Andrew F. Shorr, Eric P. Brass
Journal: Annals of Internal Medicine (2019)

Ideas and Opinions15 October 2019Ensuring Sustainability of Needed Antibiotics: Aiming for the DART BoardBrad Spellberg, MD, Travis B. Nielsen, PhD, David N. Gilbert, MD, Andrew F. Shorr, MD, MPH, MBA, and Eric P. Brass, MD, PhDBrad Spellberg, MDLos Angeles County and University of Southern California Medical Center, Los Angeles, California (B.S.)Search for more papers by this author, Travis B. Nielsen, PhDStritch School of Medicine and Parkinson School of Health Sciences and Public Health, Loyola University Chicago, Maywood, Illinois (T.B.N.)Search for more papers by this author, David N. Gilbert, MDProvidence Portland Medical Center and University of Oregon Health Sciences School of Medicine, Portland, Oregon (D.N.G.)Search for more papers by this author, Andrew F. Shorr, MD, MPH, MBAPulmonary and Critical Care Medicine Service, MedStar Washington Hospital Center, Washington, DC (A.F.S.)Search for more papers by this author, and Eric P. Brass, MD, PhDDavid Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California (E.P.B.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M19-1893 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail The initial boom of antibiotic discovery led experts in the late 1940s to predict the end of bacterial infections as a threat (1). However, by 1965, the pipeline collapsed, leaving physicians desperate for new antibiotics “to overcome the problems of resistance…against gram-negative bacillary infections…and better ones against mycobacteria” (2). These threats from a half-century ago, which are eerily similar to those today, underscore that the crisis of antibiotic resistance is neither unprecedented nor unexpected. It is recurrent and foreseeable.Years of advocacy to combat the latest crisis led to the establishment of economic incentives to support antibiotic research and development. ...References1. Johnson AS. Medicine's responsibility in the propagation of poor protoplasm. N Engl J Med. 1948;238:755-8. [PMID: 18860758] CrossrefMedlineGoogle Scholar2. Finland M, Kirby WM, Chabbert YA, et al. Round table: are new antibiotics needed? Antimicrob Agents Chemother (Bethesda). 1965;5:1107-14. [PMID: 5883409] MedlineGoogle Scholar3. Nielsen TB, Brass EP, Gilbert DN, et al. Sustainable discovery and development of antibiotics—is a nonprofit approach the future? N Engl J Med. 2019;381:503-5. [PMID: 31216396] doi:10.1056/NEJMp1905589 CrossrefMedlineGoogle Scholar4. Infectious Diseases Society of America. White paper: recommendations on the conduct of superiority and organism-specific clinical trials of antibacterial agents for the treatment of infections caused by drug-resistant bacterial pathogens. Clin Infect Dis. 2012;55:1031-46. [PMID: 22891041] CrossrefMedlineGoogle Scholar5. U.S. Food and Drug Administration. Generating Antibiotic Incentives Now. Accessed at www.fda.gov/media/110982/download on 1 August 2019. Google Scholar6. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Antibiotic resistant threats in the United States, 2013. Accessed at www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf on 1 August 2019. Google Scholar7. World Health Organization. Global priority list of antibiotic-resistant bacteria to guide research, discovery, and development of new antibiotics. Accessed at www.who.int/medicines/publications/WHO-PPL-Short_Summary_25Feb-ET_NM_WHO.pdf on 1 August 2019. Google Scholar8. Spellberg B, Bartlett JG, Gilbert DN. The future of antibiotics and resistance. N Engl J Med. 2013;368:299-302. [PMID: 23343059] doi:10.1056/NEJMp1215093 CrossrefMedlineGoogle Scholar9. Spellberg B, Srinivasan A, Chambers HF. New societal approaches to empowering antibiotic stewardship. JAMA. 2016;315:1229-30. [PMID: 26914942] doi:10.1001/jama.2016.1346 CrossrefMedlineGoogle Scholar10. Angus D, Alexander B, Berry S, et al. Adaptive Platform Trials Coalition. Adaptive platform trials: definition, design, conduct and reporting considerations. Nat Rev Drug Discov. 2019. [PMID: 31462747] doi:10.1038/s41573-019-0034-3 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: Los Angeles County and University of Southern California Medical Center, Los Angeles, California (B.S.)Stritch School of Medicine and Parkinson School of Health Sciences and Public Health, Loyola University Chicago, Maywood, Illinois (T.B.N.)Providence Portland Medical Center and University of Oregon Health Sciences School of Medicine, Portland, Oregon (D.N.G.)Pulmonary and Critical Care Medicine Service, MedStar Washington Hospital Center, Washington, DC (A.F.S.)David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California (E.P.B.)Grant Support: By grants R01 AI130060, R01 AI117211, and R42 AI106375 from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health and by grant R01 HS025690 from the Agency for Healthcare Research and Quality.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-1893.Corresponding Author: Brad Spellberg, MD, Los Angeles County and University of Southern California Medical Center, 2051 Marengo Street, Los Angeles, CA 90033; e-mail, [email protected]lacounty.gov.Current Author Addresses: Dr. Spellberg: Los Angeles County and University of Southern California Medical Center, 2051 Marengo Street, C2K126, Los Angeles, CA 90033.Dr. Nielsen: 421 Beloit Avenue, Apt 1, Forest Park, IL 60130.Dr. Gilbert: Providence Portland Medical Center and University of Oregon Health Sciences School of Medicine, 5050 Northeast Hoyt Street, Suite 540, Portland, OR 97213.Dr. Shorr: MedStar Washington Hospital Center, 110 Irving Street Northwest, Washington, DC 20010.Dr. Brass: 70 Sea Breeze Avenue, Rancho Palos Verdes, CA 90275.Author Contributions: Conception and design: B. Spellberg, T.B. Nielsen, D.N. Gilbert, E.P. Brass.Analysis and interpretation of the data: D.N. Gilbert, A.F. Shorr.Drafting of the article: B. Spellberg, T.B. Nielsen, A.F. Shorr, E.P. Brass.Critical revision of the article for important intellectual content: B. Spellberg, T.B. Nielsen, D.N. Gilbert, A.F. Shorr, E.P. Brass.Final approval of the article: B. Spellberg, T.B. Nielsen, D.N. Gilbert, A.F. Shorr, E.P. Brass.Administrative, technical, or logistic support: B. Spellberg.Collection and assembly of data: T.B. Nielsen.This article was published at Annals.org on 8 October 2019. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byA Nonprofit Drug Development Model Is Part of the Antimicrobial Resistance (AMR) SolutionMonoclonal Antibody Requires Immunomodulation for Efficacy Against Acinetobacter baumannii InfectionNIMble innovation—a networked model for public antibiotic trialsMethodological and Reporting Quality of Noninferiority Randomized Controlled Trials Comparing Antibiotic Therapies: A Systematic ReviewAlignment With Market Forces: The “Re-Whithering” of Infectious DiseasesEvaluating for-profit public benefit corporations as an additional structure for antibiotic development and commercialization 15 October 2019Volume 171, Issue 8Page: 580-582KeywordsAntibiotic resistanceAntibioticsClinical trialsDrugsInfectious diseasesInvestigational new drugMotivationMycobacteriaNew drug applicationsPathogens ePublished: 8 October 2019 Issue Published: 15 October 2019 Copyright & PermissionsCopyright © 2019 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...