[Source: US Centers for Disease Control and Prevention (CDC), Emerging Infectious Diseases Journal, full page: (LINK). Abstract, edited.]
Health Secur. 2019 Feb 6. doi: 10.1089/hs.2018.0092. [Epub ahead of print]
Evaluating Promising Investigational Medical Countermeasures: Recommendations in the Absence of Guidelines.
Bhadelia N1, Sauer L2, Cieslak TJ3, Davey RT4, McLellan S5, Uyeki TM6, Kortepeter MG7; National Ebola Training and Education Center’s Special Pathogens Research Network (SPRN)’s Medical Countermeasures Working Group.
Collaborators (12): Akers M, Dierberg K, Eiras D, Evans J, Figueroa E, Kraft C, Kratochvil C, Martins K, Measer G, Mehta A, Hu-Primmer J, Risi G.
Author information: 1 Nahid Bhadelia, MD, MA, is Medical Director, Special Pathogens Unit, Section of Infectious Diseases, Boston University School of Medicine, Boston, MA. 2 Lauren Sauer, MS, is Assistant Professor, Director of Research, Johns Hopkins Biocontainment Unit, Department of Emergency Medicine, Johns Hopkins Medicine, Baltimore, MD. 3 Theodore J. Cieslak, MD, MPH, is Associate Professor, Department of Epidemiology, University of Nebraska College of Public Health, Omaha, NE. 4 Richard T. Davey, MD, is Deputy Clinical Director, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD. 5 Susan McLellan, MD, MPH, is Medical Director, Biocontainment Treatment Unit, Division of Infectious Diseases, University of Texas Medical Branch at Galveston, TX. 6 Timothy M. Uyeki, MD, MPH, MPP, is Chief Medical Officer, Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA. 7 Mark G. Kortepeter, MD, MPH, is Professor, Department of Epidemiology, University of Nebraska College of Public Health, Omaha, NE.
Emerging and re-emerging infectious diseases pose growing global public health threats. However, research on and development of medical countermeasures (MCMs) for such pathogens is limited by the sporadic and unpredictable nature of outbreaks, lack of financial incentive for pharmaceutical companies to develop interventions for many of the diseases, lack of clinical research capacity in areas where these diseases are endemic, and the ethical dilemmas related to conducting scientific research in humanitarian emergencies. Hence, clinicians providing care for patients with emerging diseases are often faced with making clinical decisions about the safety and effectiveness of experimental MCMs, based on limited or no human safety, preclinical, or even earlier product research or historical data, for compassionate use. Such decisions can have immense impact on current and subsequent patients, the public health response, and success of future clinical trials. We highlight these dilemmas and underscore the need to proactively set up procedures that allow early and ethical deployment of MCMs as part of clinical trials. When clinical trials remain difficult to deploy, we present several suggestions of how compassionate use of off-label and unlicensed MCMs can be made more informed and ethical. We highlight several collaborations seeking to address these gaps in data and procedures to inform future clinical and public health decision making.
KEYWORDS: Drug development; Ebola; Emerging infectious diseases; Ethics; Medical countermeasures; Outbreaks
PMID: 30724616 DOI: 10.1089/hs.2018.0092
Keywords: Infectious Diseases; Emerging Diseases; Antivirals; Vaccines.