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
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
Media Coverage of Ethical Issues in Predictive Genetic Testing: A Qualitative Analysis
Examining Physician Interactions with Disease Advocacy Organizations
Vaccine development is in contention within the United States, navigating the progress of clinical research and pressures for development from the federal government. Pfizer has announced that the goal is to ask for emergency use in November.Full Article
When considering clinical research and oversight, who is in charge? The FDA is the main agency that deals with clinical oversight, but from research, “FDA’s enforcement of clinical research regulations is often light-handed, slow-moving, and secretive.” How does this relate with current clinical trials of COVID-19? How can we ensure that certain researchers are being watched for their clinical research practices?Full Article
If the COVID-19 vaccine is efficacious, what considerations need to be factored in on who receives the vaccine first? A panel recently met to tackle this question. Healthcare workers and the disadvantaged are communities heavily considered. When vaccine supplies are limited, the panel argues these groups should be considered for priority. However, when it comes to considering priority on the basis of racial health disparities due to COVID-19, this question enters gray waters.Full Article
The FDA on Tuesday told coronavirus vaccine developers that it will hold them to strict standards for emergency authorization, releasing new guidelines that the White House had fought against for weeks. This decision comes after weeks of debate on guidelines that would affect the feasibility of having a vaccine ready by election time.Full Article
“Vaccines may be our best hope for a safe return to workplaces, parties, stores and schools, but even if all leading vaccine candidates are protective, the British charity Oxfam estimates that nearly two thirds of the world’s population will not have access until at least 2022.” Could the common cold help ease the pandemic? Writers speculate in this Scientific American piece.Full Article
The scandal about hydroxychloroquine turned heads earlier this year in the context of the COVID-19 pandemic. This article explores the situation with Surgisphere, the company behind the data for studies that have since been retracted.Full Article
“Immigrants detained at an ICE-contracted center in Georgia said they had invasive gynecology procedures that they later learned might have been unnecessary.” Bioethics is crucial in making sure situations like these are brought to attention. Patients deserve a right to informed consent and the right to refuse any procedure that is not done in the interest of their own good. Beneficence is a principle of bioethics that heavily relates to this situation.Full Article
Is the future of COVID-19 therapy plasma therapy? Many have concerns over Trump’s past authorization of plasma therapy for COVID-19 patients. Coronavirus treatment methods have been debated across the United States. “Dozens of major hospitals across the U.S. are grappling with whether to ignore a federal decision allowing broader emergency use of blood plasma from recovered COVID patients.”Full Article
Access to an efficacious vaccine is crucial for vulnerable patients. According to this piece on COVID-19 vaccine trials, “excluding older adults means that the ability to evaluate safety and effectiveness will be systematically limited.” In order to develop treatments that improve the health of all, it is imperative to include those disproportionately affected in the search for these treatments. However, this is contingent on trust between the community of interest and the researchers.Full Article