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Finding Effective Treatments for COVID-19Scientific Integrity and Public Confidence in a Time of Crisis

Educational Objective
To understand why public trust in scientific integrity is vital during a time of crisis
1 Credit CME

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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Article Information

Corresponding Author: Jesse L. Goodman, MD, MPH, Georgetown University, 3900 Reservoir Rd, Washington, DC 20057 (jesse.goodman@georgetown.edu).

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.

References
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2.
US Food and Drug Administration. Request for emergency use authorization for use of chloroquine phosphate or hydroxychloroquine sulfate supplied from the strategic national stockpile for treatment of 2019 coronavirus disease. Published March 28, 2020. Accessed April 13, 2020. https://www.fda.gov/media/136534/download
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Goodman  JL .  Studying “secret serums”—toward safe, effective Ebola treatments.   N Engl J Med. 2014;371(12):1086-1089. doi:10.1056/NEJMp1409817PubMedGoogle ScholarCrossref
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London  AJ , Omotade  OO , Mello  MM , Keusch  GT .  Ethics of randomized trials in a public health emergency.   PLoS Negl Trop Dis. 2018;12(5):e0006313. doi:10.1371/journal.pntd.0006313PubMedGoogle Scholar
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Touret  F , de Lamballerie  X .  Of chloroquine and COVID-19.   Antiviral Res. 2020;177:104762. doi:10.1016/j.antiviral.2020.104762PubMedGoogle Scholar
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US Department of Health and Human Services. Emergency use authorization of medical products and related authorities. Published January 2017. Accessed April 13, 2020. https://www.fda.gov/media/97321/download
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Remarks by President Trump, Vice President Pence, and members of the coronavirus task force in press briefing. WhiteHouse.gov. April 6, 2020. Accessed April 13, 2020. https://www.whitehouse.gov/briefings-statements/remarks-president-trump-vice-president-pence-members-coronavirus-task-force-press-briefing-20/
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Diamond  D , Toosi  N . White House pressures FDA on unproven Japanese drug. Politico. March 31, 2020. Accessed April 13, 2020. https://www.politico.com/news/2020/03/31/white-house-pressures-fda-japanese-drug-157587
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Fuerstein  A . Rudy Giuliani wants FDA to fast-track a stem cell therapy for Covid-19; critics see political meddling. STAT. March 31, 2020. Accessed April 13, 2020. https://www.statnews.com/2020/03/31/rudy-giuliani-wants-fda-to-fast-track-a-stem-cell-therapy-for-covid-19-critics-see-political-meddling/
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Zhang  Q , Wang  Y , Qi  C , Shen  L , Li  J .  Clinical trial analysis of 2019-nCoV therapy registered in China.   J Med Virol. Published online February 18, 2020. doi:10.1002/jmv.25733PubMedGoogle Scholar
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