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
“As the Covid-19 pandemic has laid bare the racial inequalities in the United States’ health care system, entrepreneurs in genetic research are speaking out about the importance of encouraging community outreach to combat those disparities and increasing diversity inside their own industry.”Full Article
“The clinicians also painted a grim picture of their lives, as the pandemic enters a newly robust phase with record case counts in the United States. About half already said their mental exhaustion was at an all-time high. Many worried about keeping their doors open: about 7 percent said they were not sure they could remain open past December without financial help.”Full Article
“The liquid that many hope could help end the Covid-19 pandemic is stored in a nondescript metal tank in a manufacturing complex owned by Pfizer, one of the world’s biggest drug companies. There is nothing remarkable about the container, which could fit in a walk-in closet, except that its contents could end up in the world’s first authorized Covid-19 vaccine.” All eyes are on these developers as the race towards a COVID-19 vaccine continues. Rates run high and tensions are tough as the world grapples with the pandemic.Full Article
“In the imminent future, patients will start to die because there simply aren’t enough people to care for them. Doctors and nurses will burn out. The most precious resource the U.S. health-care system has in the struggle against COVID-19 isn’t some miracle drug. It’s the expertise of its health-care workers—and they are exhausted.”Full Article
“With the emergency use authorization process in a swirl of controversy, understanding the ethical dimensions of issuing it for a vaccine can provide clarity on the necessity of stringent guidelines from the FDA.”Full Article
Recent news offers compelling evidence that an effective vaccine for #COVID19 is on its way. Although this news provides optimism, many questions are considered. Who gets it first? Could it help quell the pandemic? Questions follow this exciting news.Full Article
What could infections among animals mean for humans, especially in the context of COVID-19? The decision to kill Mink by the Danish government echoes concerns about mutations that occur with coronavirus and its implications for human health. What do we do?Full Article
“A lab experiment aimed at fixing defective DNA in human embryos shows what can go wrong and why leading scientists say it’s too unsafe. In more than half of the cases, the editing caused unintended changes, such as loss of an entire chromosome.” Evident from the analysis of the CRISPR babies made in the years prior, embryo editing has proved to be unstable and not ready for widespread use despite the potentials of editing in solving certain health conditions.Full Article
More and more microbes are becoming resistant to antimicrobial drugs, yet why are fewer antibiotics entering the market? For some, there is a lack of financial incentive to develop antibiotics and firms drop out in pursuit of more profitable drug lines.Full Article