Biotechnology in the Time of COVID-19: Commentaries from the Front Line by Levin Jeremy M

Author:Levin, Jeremy M. [Levin, Jeremy M.]
Language: eng
Format: epub
Publisher: RosettaBooks
Published: 2020-05-30T16:00:00+00:00

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LESSONS

Kenneth I. Moch

Bioethics and the Need for Ethical Leadership During the COVID-19 Pandemic

Throughout history, medical crises have accelerated the development of new medical products and procedures. 7 The COVID-19 pandemic is such a crisis, threatening human life in a potentially uncontrollable and unpredictable manner.

The biotechnology community has responded to this pandemic by marshaling its enormous skills and scientific resources toward developing new medical countermeasures—particularly therapeutics and vaccines. This has been done with such intensity that as of this writing over 950 inquiries for drug and vaccine proposals have been received by the FDA (“an overwhelming amount in a short period of time”), over seventy clinical trials are ongoing in the US, and over 200 other development programs are in planning stages. 8

Beyond evaluating the benefits and risks of each potential medical countermeasure to treat the infected, control the spread, or prevent recurrence, many fundamental ethical questions must also be addressed. The most complex are these: Who decides the specific parameters of each clinical development pathway; how are the decisions made; and what are the near- and long-term impacts and implications of these decisions? Said differently, who decides “who shall live” and adjudicates the ethical implications of decisions that are inherent in the clinical development pathway for new medical countermeasures?

Philosophers and bioethicists often look at questions like these through the lens of the “Trolley Dilemma,” which revolves around the ethical and moral complexities of deciding who to save in a life-or-death situation and whether such a decision passively or actively causes harm to others. 9 In the face of the COVID-19 crisis, biotechnology companies are developing a spectrum of new medical countermeasures under extreme time and resource constraints coupled with an incomplete understanding of the course and the complications of this new disease. As a result, biotech company leaders are facing extraordinarily complex ethical questions akin to the Trolley Dilemma. Among the questions are these:

How do you evaluate benefits and risks to different patient populations at different stages of the disease? What are the impacts of these risk/benefit decisions on the applicability of the resultant data to current or future patients in those other population segments?

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