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Therapeutic Challenges in COVID-19
Published in Debmalya Barh, Kenneth Lundstrom, COVID-19, 2022
Alaa A. A. Aljabali, Murtaza M. Tambuwala, Debmalya Barh, Kenneth Lundstrom
Two major strategies have been pursued for COVID-19 drug development. In one approach, existing approved drugs for other indications, such as viral and parasitic infections, have been repurposed for targeting SARS-CoV-2 infections. The apparent benefits of this strategy are the swift production and approval of these products for human use. The drawbacks are the unclear consequences on SARS-CoV-2 of the repurposed medications, and any negative effects caused to COVID-19 patients. The other strategy has been to developed novel antiviral pharmaceutical products based on computational biology, structural biology, and high-throughput screening, targeting signaling pathways, and exploring new viral inhibitors for cellular entry and replication. Examples of COVID-19 drugs are summarized in Table 3.1. Chloroquine (CQ) and hydroxychloroquine (HCQ) were developed primarily for malaria treatment and initially received much attention as prominent candidates for the treatment of COVID-19 patients [2, 3]. Initial excitement related to reduced viral load in COVID-19 patients treated with HCQ [6] quickly disappeared when it was revealed that the clinical study design was inadequate, and the obtained results were not reliable [7]. Moreover, a systematic review and meta-analysis based on twelve observational studies and three randomized clinical trials in 10,659 COVID-19 patients treated with HCQ showed no significant reduction in mortality, time to fever resolution, clinical deterioration, and development of acute respiratory distress syndrome (ARDS) [8]. In contrast, patients treated with HCQ posed a greater risk of ECG abnormalities and arrhythmia.
Decisions on Innovation or Research for Devastating Disease
Published in The American Journal of Bioethics, 2021
M. H. Andreae, L. D. Shah, V. Shepherd, M. Sheehan, H. S. Sacks, R. Rhodes
In their paper, “Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases?” Holly Fernandez Lynch and colleagues have presented a valuable account of treatment and research decisions made during the COVID-19 pandemic (Lynch et al. 2021). Their discussion focuses on patients with other serious diseases and their families who ask “what about us?” They wonder why the conditions important to them have not received similar research attention. While we largely agree with the authors’ account and their insightful observations, we want to highlight the manifest tension between innovation and research which they did not emphasize.
What Can We Learn from COVID-19 Drug Development and Access for Non-Pandemic Diseases? A Chinese Perspective
Published in The American Journal of Bioethics, 2021
Hui Zhang, Zhiping Guo, Lijun Shen, Yongguang Yang, Zhenxiang Zhang, Yuming Wang
Finally, in light of the relatively weak regulatory capacity compared with developed countries and the experience of Western countries, China has revised the “Provisions for Drug Registration” (effective July 1, 2020), which includes breakthrough therapy drug procedures, conditional approval procedures, priority evaluation and approval procedures, and special approval procedures, to expedite the development of innovative drugs with clinical value for approval (Dai et al. 2021). Thus, we believe that the lessons learned from COVID-19 drug development and access in the US would also provide valuable ideas and references.
Please, Don’t Fly Me to the Moon
Published in The American Journal of Bioethics, 2021
Years after the publication of “Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Disease?” I hope it continues to animate and guide science policy and drug development decisions. The Department of Health and Human Services (CDC, FDA, and NIH in particular), Congress and the executive branch, academic medicine, disease advocates, the press and the pharmaceutical industry all can learn from Holly Fernandez-Lynch and colleagues’ (2021) thorough, well-researched and organized essay. Several important points stand out.