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Everyone wants new treatments and vaccines to address the devastation of coronavirus disease 2019 (COVID-19). But, currently, under intense pressure and based on hope and limited data from poorly conducted clinical trials and observational data, many clinicians are embarking on ill-advised and uncontrolled human experimentation with unproven treatments.1 This approach cannot provide answers about what treatments are effective, and it poses undue risk to patients. In this light, decisions to seek and invoke Emergency Use Authorization (EUA) authorities from the US Food and Drug Administration (FDA), such as the recent EUA for chloroquine and hydroxychloroquine,2 which will further increase use of these drugs for treating individuals with COVID-19, are noteworthy and deserve careful attention. Not only are there potential negative consequences from uncontrolled use of these drugs based on currently unconvincing data but, equally concerning, the integrity of governmental decision-making is increasingly coming under pressure, risking harm to both patients and to the public confidence needed to respond effectively to this pandemic.
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Corresponding Author: Jesse L. Goodman, MD, MPH, Georgetown University, 3900 Reservoir Rd, Washington, DC 20057 (firstname.lastname@example.org).
Published Online: April 16, 2020. doi:10.1001/jama.2020.6434
Conflict of Interest Disclosures: Dr Goodman reported receiving travel and meeting expenses from US Pharmacopeia; compensation (including equity) for service as a board member and travel and meeting expenses from GlaxoSmithKline; and compensation for service as a board member, equity options, and reimbursement for travel expenses from Intellia Therapeutics outside the submitted work and was previously the US Food and Drug Administration’s chief scientist. Dr Borio is the vice president of In-Q-Tel and was previously director for medical and biodefense preparedness policy at the US National Security Council and, before that, the acting chief scientist at the US Food and Drug Administration.
Disclaimer: The views expressed are solely those of the authors and not those of any institutions they are or have been affiliated with.
Additional Contributions: We thank Nicole Lurie, MD, MSPH (Coalition for Epidemic Preparedness Innovations), for helpful comments.
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