When coronavirus patients don’t have time to wait: Pandemic forces ethical shift in assessing treatments

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This article or excerpt is included in the GLP’s daily curated selection of ideologically diverse news, opinion and analysis of biotechnology innovation.

Normally, it takes about eight years to move a drug through clinical trials and approval by the US Food and Drug Administration. In the current pandemic, patients don’t have this time to wait for COVID-19 therapies. How can we responsibly speed innovation, access to experimental medicines, and FDA approvals during this public health emergency?

There is no shortage of calls to act more quickly in response to this pandemic. …

Putting aside the ethics of acting without due caution or data, it’s worth noting that the US has been accelerating the drug approval process and approving drugs with less evidence for years. …

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Still, this acceleration isn’t enough in this pandemic. Undertaking clinical trials is usually the best way to advance drug development and get experimental drugs to patients, but their timelines and strict inclusion criteria leave a lot of patients without drug access for many years.

In mass critical-care events, such as the current pandemic, bioethics generally gives way to public health ethics. Whereas bioethics traditionally focuses on the health and interests of individual patients and the private doctor-patient interaction, public health ethics focuses on groups and decisions by authorities responsible for large numbers of people.

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