Hot Topics: Clinical Trials & Studies
Brian M. Cummings, MD and John J. Paris, SJ, PhD
In The New York Times, almost overlooked amidst multiple articles on Covid-19 published that day, we found a challenging essay by Max Fisher entitled, “Europe’s Vaccine Ethics Call: Do No Harm and Let More Die”? …Full Article
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
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
What harms do unapproved stem cell interventions bring to patients? There is debate on how these interventions should be managed by the FDA. “Many of these unapproved interventions have led to life-threatening infections, chronic pain, and even death.”Full Article
Medical journals publish many studies that link racism to socioeconomic or biological factors. “Less often do their editors, mostly white and male, accept papers that explore how systemic racism shapes the health care experiences of Black and brown people.”Full Article
How do we see evidence and COVID-19? “With the pandemic now deep into its second year, it’s clear the crisis has exposed major weaknesses in the production and use of research-based evidence — failures that have inevitably cost lives.”Full Article
The J&J vaccine pause has been a source of recent debate and concern. “Use of the one-shot Johnson & Johnson Covid vaccine will resume within days, but with a warning added to its label about the risk for a rare blood-clotting disorder.”Full Article
“When people are asked simply to trust biomedical experts, there seems to be a discounting of the real possibility and the appropriateness of scientific disagreements. The exhortations might leave people confused, skeptical, and unsure.”Full Article
Vaccine rollout of the Johnson & Johnson has paused in the United States, ” a “pause” that now looks indefinite and threatens to upend vaccination efforts overseas and in some of the most marginalized communities in the United States.”Full Article
Where do we go from here in fighting COVID-19? “Now, researchers are racing to develop the next generation of COVID-19 vaccines, utilizing a variety of innovative technologies to produce more convenient and more potent options.”Full Article
As states begin to vaccinate more people, “everyone needs to grapple with questions of equity — how to improve vaccine access for all Americans, especially for groups historically made most vulnerable to severe illness.”Full Article
“From academic research centers to intensive care units (ICUs) to scientific journals to government agencies, scientists fighting the pandemic say they are hitting a wall, 15 months after the first report of a cluster of cases introduced the virus “Full Article
Can we work faster to make vaccines? How can we get vaccines distributed across the world? What are the ethical challenges of vaccine distribution? All these questions need to be considered for what it takes to vaccinate the world against COVID-19.Full Article