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Regulatory Agencies

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

JAMA

Published Online: April 16, 2020

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Article Information and Disclosures

Jesse L. Goodman, MD, MPH¹;

Luciana Borio, MD²

Author Affiliations

¹Georgetown University, Washington, DC
²In-Q-Tel, Arlington County, Virginia

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Treatment of Critically Ill Patients With COVID-19 With Convalescent Plasma

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James M. Sanders, PhD, PharmD; Marguerite L. Monogue, PharmD; Tomasz Z. Jodlowski, PharmD; James B. Cutrell, MD
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Treating COVID-19—Off-Label and Compassionate Use and Clinical Trials During Pandemics

Andre C. Kalil, MD, MPH
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Emergency Use Authorization of Remdesivir

Michael G. Ison, MD, MS; Cameron Wolfe, MBBS, MPH; Helen W. Boucher, MD
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W. Joost Wiersinga, MD, PhD; Andrew Rhodes, MD, PhD; Allen C. Cheng, MD, PhD; Sharon J. Peacock, PhD; Hallie C. Prescott, MD, MSc
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Therapy for Early COVID-19—A Critical Need

Peter S. Kim, MD; Sarah W. Read, MD, MHS; Anthony S. Fauci, MD

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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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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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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

Goodman JL . Studying “secret serums”—toward safe, effective Ebola treatments. N Engl J Med. 2014;371(12):1086-1089. doi:10.1056/NEJMp1409817 PubMed Google Scholar Crossref

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.0006313 PubMed Google Scholar

Touret F , de Lamballerie X . Of chloroquine and COVID-19. Antiviral Res. 2020;177:104762. doi:10.1016/j.antiviral.2020.104762 PubMed Google Scholar

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

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/

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

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/

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.25733 PubMed Google Scholar

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.