Publication Date

2020-08-03

Document Type

Article Postprint

Disciplines

Bioethics and Medical Ethics | Clinical Trials | Infectious Disease | Pharmacy and Pharmaceutical Sciences | Therapeutics | Virus Diseases

Abstract

FDA is the gatekeeper to protect the public health and is critical to sustain US global leadership in drug innovation. Our foundation of evidence-based clinical practice is based on large, well-designed randomized controlled trials. The failure of HCQ against COVID-19 stands as prime example of the urgent need for adherence to science. Rigorous scientific objectivity Downloaded from https://academic.oup.com/ajhp/advance-article/doi/10.1093/ajhp/zxaa257/5879960 by Medical Center Library user on 17 August 2020 13 and independence must prevail in any future EUA decision by FDA. Trust in FDA’s mission to approve safe and effective medications was built over decades by the capable scientists working for the agency, and the integrity of public trust must be protected to conquer future pandemics and ensure safe use of vaccines against COVID-19 once they become available.

Keywords

COVID-19, evidence-based practice, Food and Drug Administration, hydroxychloroquine, randomized clinical trial

Rights and Permissions

This work is written by (a) US Government employee(s) and is in the public domain in the US.

DOI of Published Version

10.1093/ajhp/zxaa257

Source

Guharoy R, Krenzelok E. Searching for COVID-19 treatments: First, do no harm. Am J Health Syst Pharm. 2020 Aug 3:zxaa257. doi: 10.1093/ajhp/zxaa257. Epub ahead of print. PMID: 32744592. Link to article on publisher's site

Journal/Book/Conference Title

American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists

Related Resources

Link to Article in PubMed

PubMed ID

32744592

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