Hot Topics: Clinical Trials & Studies
by Berklee Robins, MD, MA & Ashley Sweet, MD, MBE
Vaccines are approved when it is clear that the benefits to the individual and society outweigh the potential risks and side effects of vaccination.…Full Article
This editorial appears in the September issue of the American Journal of Bioethics
by David Magnus, PhD
This issue features a set of articles addressing allocation issues for drugs for COVID-19 that have not been approved by the FDA but are available through either Emergency Use Authorization or Expanded Access Programs (EAP).…
by Kiarash Aramesh M.D., Ph.D.
The COVID-19 pandemic has been accompanied by a surge of pseudoscientific claims, sometimes made or supported by political powers.…Full Article
by Jamie Webb MA, MSci
‘An experimental vaccine against the coronavirus showed encouraging results in very early testing, triggering hoped-for immune responses in eight healthy, middle-aged volunteers, its maker announced Monday.’…Full Article
by Jing Wan,Yuqiong Huang, Amaneh Abdel Hafez Aljaafreh, Dandan Dong, Yali Cong , Jun Lin, Hongxiang Chen
COVID-19 is an emerging infectious disease that is extremely contagious and can cause serious consequences and even death.
by Keisha Ray, Ph.D.
I take the drug hydroxychloroquine, brand name Plaquenil, for an autoimmune disease. Hydroxychloroquine was once used to treat malaria and is now commonly used to treat a range of inflammatory disorders like lupus and rheumatoid arthritis.…Full Article
by Craig Klugman, Ph.D.
In a news item reported in Rolling Stone, NPR, and The Houston Chronicle, the medical director of a coastal Texas nursing home used his political connections to get enough hydroxychloroquine to begin his own “observational” trials—minus a control group, minus informed consent, minus informing anyone.…Full Article
by Ariadne A. Nichol, B.A.
Development of experimental vaccines to combat the COVID-19 pandemic has been rapidly progressing. In the United States, several Phase I clinical trial participants already received an injection of mRNA-1273, the experimental vaccine developed by the National Institutes of Health (NIH) and a biotechnology firm called Moderna.…Full Article
by Craig Klugman, Ph.D.
On March 31, the U.S. Department of Justice put in an order for $60,000 worth of hydroxychloroquine, a drug that Trump has been pushing as a treatment for COVID-19 (to clarify, it is unproven and has never worked on any other coronavirus).…Full Article
by Farid Rahimi, Ph.D. ELS and Amin Talebi Bezmin Abadi, Ph.D.
The first reports of “pneumonia of unknown cause” emerged from the Wuhan City, China, three months ago.…Full Article
Self-Defeating Codes of Medical Ethics and How to Fix Them: Failures in COVID-19 Response and Beyond
Don’t Blame Hippocrates for Low Enrollment in Clinical Trials
Ethically Allocating COVID-19 Drugs Via Pre-approval Access and Emergency Use Authorization
The Limits of Individualism: Potential Societal Harms from the EAP for Convalescent Plasma
Partnering With Patients to Bridge Gaps in Consent for Acute Care Research
Patient’s Perspectives of Experimental HCV-Positive to HCV-Negative Renal Transplantation: Report from a Single Site
Misrepresenting “Usual Care” in Research: An Ethical and Scientific Error
Ethics and Collateral Findings in Pragmatic Clinical Trials
How is medical ethics debated in court? “If a Texas court ruling is allowed to stand, the state’s hospitals and doctors will have no room to make end-of-life care decisions based on independent medical ethics or individual conscience.”Full Article
Do we have an ethical responsibility to communicate COVID-19 diagnoses for the purpose of collective health security? This recent piece explores why some may feel motivated to keep their own diagnoses a secret and what effect that may have on the pandemic.Full Article
Vaccine hesitancy has been an important topic for discussion regarding the #COVID19 vaccine. “How can medical and public health leaders work to overcome this hesitancy? To start with, acknowledge the historical reasons for black mistrust of medicine.”Full Article
A big component of vaccine distribution has been utilizing ethics to determine vaccine prioritization. Issac Chotiner of The New Yorker speaks with immunologist Barry Bloom to discuss what goes into making decisions on vaccine distribution.Full Article
“The first year of the Covid-19 pandemic revealed that a country’s wealth would not spare it from the virus. Overconfidence, poor planning and ignored warnings felled the world’s richest nations. But now, money is translating into undeniable advantages.”Full Article
With efficacious medications available, ethics considers who has access to these drugs and who is at risk of losing them. Under COVID-19, the pandemic has accelerated the growth of many health disparities in the United States. Recently, there has been an increase in “pharmacy deserts”, where people struggle to fill medications locally because the drugs are no longer covered by Medicare of Medicaid.Full Article
The new COVID-19 variants that have popped up in the United Kingdom and South Africa are the new obstacles to tackle in the pandemic. Will current vaccines be able to measure up against new strains? Scientists are seeking an answer.Full Article
Why has vaccine distribution fallen into disarray across the United States? Lack of funding and coordination between state and local governments has left citizens confused about their vaccination opportunities. What will come in year 2 of COVID-19?Full Article
Recent data has shown COVID-19 numbers are trending in the wrong directions for our populations at risk. With the vaccine soon to be rolled out, what needs to be considered in distribution as we look at the effects of COVID-19 on elderly populations?Full Article
With news of the recent COVID19 vaccines in development, we look to some of the technologies that have enable us to crate innovative drugs and vaccines. Nanotechnology allows important necessary particles get where they need to go.Full Article