News from Bioethics.com

AstraZeneca, Under Fire for Vaccine Safety, Releases Trial Blueprints

10 hours 51 min

(New York Times) – AstraZeneca revealed details of its large coronavirus vaccine trials on Saturday, the third in a wave of rare disclosures by drug companies under pressure to be more transparent about how they are testing products that are the world’s best hope for ending the pandemic.Polls are finding Americans increasingly wary of accepting a coronavirus vaccine. And scientists inside and outside the government are worried that regulators, pressured by the president for results before Election Day on Nov. 3, might release an unproven or unsafe vaccine.

The Core Lesson of the COVID-19 Heart Debate

10 hours 55 min

(The Atlantic) – Autopsies have found traces of the coronavirus’s genetic material in the heart, and actual viral particles within the heart’s muscle cells. Experiments have found that SARS-CoV-2 can destroy lab-grown versions of those cells. Several studies have now shown that roughly 10 to 30 percent of hospitalized COVID-19 patients had high levels of troponin—a protein released into the blood when the heart’s muscle cells are damaged. Such patients are more likely to die than others with no signs of heart injury. This is worrying for people with severe symptoms, but more recently, a few studies suggested that COVID-19 can cause heart inflammation, or myocarditis, even in people who showed mild symptoms, or had recovered. These results were controversial but concerning.

WHO Unveils Global Plan to Fairly Distribute COVID-19 Vaccine, But Challenges Await

10 hours 58 min

(Science) – The World Health Organization (WHO) announced today that countries representing close to two-thirds of the world’s population have joined its plan to buy and fairly distribute COVID-19 vaccines around the globe. It also unveiled the mechanism through which it plans to allocate the vaccine as it becomes available, aiming “to end the acute phase of the pandemic by the end of 2021.”

Rural Hospitals Teeter on Financial Cliff as COVID Medicare Loans Come Due

11 hours 6 sec

(Kaiser Health News) – More than 65% of the nation’s small, rural hospitals — many of which were operating at a deficit before the pandemic — jumped at the Medicare loans when the pandemic hit because they were the first funds available, said Maggie Elehwany, former vice president of government affairs for the National Rural Health Association. CMS halted new loan applications to the program at the end of April.

When AI in Healthcare Goes Wrong, Who Is Responsible?

11 hours 19 min

(Quartz) – Artificial intelligence can be used to diagnose cancer, predict suicide, and assist in surgery. In all these cases, studies suggest AI outperforms human doctors in set tasks. But when something does go wrong, who is responsible? There’s no easy answer, says Patrick Lin, director of Ethics and Emerging Sciences Group at California Polytechnic State University. At any point in the process of implementing AI in healthcare, from design to data and delivery, errors are possible.

Russia Is Slow to Administer Virus Vaccine Despite Kremlin’s Approval

1 day 9 hours

(The New York Times) – More than a month after becoming the first country to approve a coronavirus vaccine, Russia has yet to administer it to a large population outside a clinical trial, health officials and outside experts say. The approval, which came with much fanfare, occurred before Russia had tested the vaccine in late-stage trials for possible side effects and for its disease-fighting ability. It was seen as a political gesture by President Vladimir V. Putin to assert victory in the global race for a vaccine.

Migrant Detention Centers Have a Long History of Medical Neglect and Abuse

1 day 9 hours

(The Washington Post) – The recent allegation that a doctor has performed hysterectomies on immigrant women at the Irwin County Detention Center in Georgia has sparked calls for investigation. The disturbing allegation is only the latest case of systemic medical neglect and mistreatment in immigration detention settings. The spread of the novel coronavirus has been particularly devastating for people in migrant detention centers. The difficulty of social distancing within these centers has led to outbreaks at facilities throughout the country — including most recently at an ICE detention center in Adelanto, Calif., where six people have been hospitalized.

Europe Coronavirus Cases Surge as Countries Prepare Drastic Measures Against Second Wave

4 days 14 hours

(Newsweek) – Coronavirus cases in Europe have climbed past five million, with over 300,000 new infections reported last week alone across the region. Between September 7 and September 13, Europe reported 323,536 new COVID-19 cases, according to the latest report Thursday from the WHO.

AstraZeneca Denies Vaccine Trial Subject Had Nerve Ailment

4 days 14 hours

(Bloomberg) – AstraZeneca Plc, the drugmaker working with the University of Oxford on a Covid-19 vaccine, contradicted a report that a volunteer in U.K. tests of the shot developed a rare nerve disease that might have signaled severe safety problems. AstraZeneca was responding Thursday to a CNN report citing documents indicating that the diagnosis of the participant was confirmed as transverse myelitis. The diagnosis was “based on preliminary findings,” and is inaccurate, the Cambridge, England-based drugmaker said in an emailed statement.

Iran Appears to Be in Grip of ‘Third Wave’ of Coronavirus Outbreak

4 days 14 hours

(The Guardian) – Iran appears to be in the grip of a “third wave” of the coronavirus outbreak, with the number of new infections above 3,000 a day – as high as at any point since the virus first hit in February. Iran was one of the first countries to be struck by the virus outside China. Its officials brought the disease under a form of control by early May, but then experienced an increase at the start of June that drifted down to fewer than 1,600 new cases a day in late August.

Drug Shows Promise in 1st Largely Minority COVID-19 Study

4 days 14 hours

(ABC News) – A drug company said Friday that a medicine it sells to tamp down inflammation has helped prevent the need for breathing machines in hospitalized COVID-19 patients in the first large study that primarily enrolled Hispanics and Blacks. Switzerland-based Roche reported the results for tocilizumab, sold now as Actemra and RoActemra for treating rheumatoid arthritis and some other diseases.

AP Exclusive: More Migrant Women Say They Didn’t OK Surgery

4 days 14 hours

(Associated Press) – An Associated Press review of medical records for four women and interviews with lawyers revealed growing allegations that Amin performed surgeries and other procedures on detained immigrants that they never sought or didn’t fully understand. Although some procedures could be justified based on problems documented in the records, the women’s lack of consent or knowledge raises severe legal and ethical issues, lawyers and medical experts said.

Nursing Homes Given Federal Go-Ahead to Allow More Visitors

4 days 14 hours

(NPR) – The Centers for Medicare and Medicaid Services, which regulate nursing facilities, are lifting the ban on visitors, effective immediately. CMS imposed the restriction in March in an effort to control outbreaks of the coronavirus. Advocates for nursing home residents and family organizations have been clamoring for a repeal, noting the many residents who have suffered anxiety or depression, as well as physical or mental decline since the ban was imposed. The issue was also raised in the report of the Coronavirus Commission for Safety and Quality in Nursing Homes, which became public on Wednesday. 

Coronavirus May Increase Premature Births, Study Suggests

5 days 6 hours

(New York Times) – Pregnant women who are infected with the coronavirus and hospitalized are at risk for developing serious complications, and may face an elevated risk for delivering their babies prematurely, according to new studies from the Centers for Disease Control and Prevention. They may also be at greater risk of losing the pregnancy or having a stillbirth.

Moderna Shares the Blueprint for Its Coronavirus Vaccine Trial

5 days 7 hours

(The New York Times) – The biotech company Moderna released a 135-page document on Thursday that spells out the details of how it is conducting the late-stage trial of its coronavirus vaccine, and how safety and efficacy will be determined. The document suggests that the first analysis of the trial data may not be conducted until late December, and that there may not be enough information then to determine whether the vaccine works. Subsequent analyses, scheduled for March and May, are more likely to provide an answer.

An ‘Uncoordinated’ Immune Response May Explain Why COVID-19 Strikes Some Hard, Particularly the Elderly

5 days 7 hours

(Science) – Even a world-class orchestra will produce a cacophony if its strings, woodwinds, brass, and percussion sections don’t play in harmony. Similarly, the sophisticated human immune system can fail to beat back a pathogen if its many players don’t hit the right notes at the right times. A new study now finds that people who suffer the most from COVID-19 have an immune response that’s out of sync.

Clinician Deaths from COVID-19: ‘A Crisis on a Staggering Scale’

5 days 7 hours

(Medscape) – More than 7000 healthcare workers worldwide have died of COVID-19, according to a new analysis released this month by Amnesty International. The group called it “a crisis on a staggering scale.” Mexico has had the most healthcare workers affected (1320 deaths), followed by the United States (1077), the United Kingdom (649), and Brazil (634).

U.S. Plans to Ship First Covid-19 Vaccine 24 Hours After Authorization

5 days 7 hours

(The Wall Street Journal) – The U.S. government plans to begin shipping the first Covid-19 vaccine within 24 hours after regulators authorize its use, federal health officials said. Shipments of the first vaccine cleared for use would start soon after the U.S. Food and Drug Administration issued the OK, according to plans that federal health officials released Wednesday. Vaccine makers have already begun manufacturing doses so they will be ready for shipment should the shots prove to work safely in testing and regulators authorize their use.

 

Safety Driver Charged in 2018 Incident Where Self-Driving Uber Car Killed a Woman

6 days 8 hours

(The Guardian) – Prosecutors in Arizona charged the safety driver behind the wheel of a self-driving Uber test car that struck and killed a woman in 2018 with negligent homicide. Court records show that Rafaela Vasquez, 46, on Tuesday pleaded not guilty in the death of Elaine Herzberg. Vasquez is the only person facing criminal consequences in the first death of a pedestrian involving a self-driving vehicle, after prosecutors last year said Uber was not criminally liable in the crash.

To Find a Vaccine for COVID-19, Will We Have to Deliberately Infect People?

6 days 9 hours

(National Geographic) – Josh Morrison isn’t a doctor or scientist, but as a well-intentioned activist he’s provoked a fierce debate over how to develop a coronavirus vaccine. To speed up testing, he wants to be deliberately infected with the coronavirus. And he’s drawn considerable attention to his cause by starting a nonprofit that already has recruited more than 37,000 volunteers to get infected too—all in the name of science.

Lilly’s Covid-19 Antibody Helps Some Patients Rid Their Systems of Virus Sooner in Early Analysis

6 days 9 hours

(STAT News) – A drug being developed by Eli Lilly helped sick patients rid their systems of the virus that causes Covid-19 sooner and may have prevented them from landing in the hospital, according to newly released data. The drug is what is known as a monoclonal antibody, which experts view as being among the most likely technologies to help treat Covid-19. It’s a manufactured version of the antibodies that the body uses as part of its response to a virus. 

World Health Organization Announces Distribution Plan for COVID-19 Vaccine

6 days 9 hours

(ABC News) – As the possibility of a widely available COVID-19 vaccine steadily approaches, initial limitations in supply have left experts worldwide asking: Who gets the vaccine first? The World Health Organization and its appointed Strategic Advisory Group of Experts on Immunization, or SAGE, have released a worldwide vaccine distribution plan — it pushes back on so-called vaccine nationalism, the idea that each country should prioritize its own citizens.

Pfizer COVID-19 Vaccine Trial Reaches Initial Goal of 30,000 Volunteers

6 days 9 hours

(WFAA) – Pfizer announced on Wednesday that it has reached its initial goal of 30,000 participants for the phase 3 trial of its coronavirus vaccine.  Over the weekend, the drugmaker submitted an “amended protocol” to the U.S. Food and Drug Administration to expand the enrollment for its trial to about 44,000 participants. The company said in a statement that this would help increase the diversity of the trials.

AstraZeneca COVID-19 Vaccine Trial in US on Hold Until at Least Midweek: Sources

6 days 9 hours

(Medscape) – AstraZeneca’s COVID-19 vaccine trial remains on hold in the United States pending a U.S. investigation into a serious side effect in Britain even as other trials of the vaccine resume, sources familiar with the details told Reuters. AstraZeneca on Saturday said it had restarted its trial in Britain after regulators completed their review of a serious side effect in one trial participant there.

How COVID-19 Can Damage the Brain

1 week 7 hours

(Nature) – In the early months of the COVID-19 pandemic, doctors struggled to keep patients breathing, and focused mainly on treating damage to the lungs and circulatory system. But even then, evidence for neurological effects was accumulating. Some people hospitalized with COVID-19 were experiencing delirium: they were confused, disorientated and agitated. In April, a group in Japan published the first report of someone with COVID-19 who had swelling and inflammation in brain tissues. Another report described a patient with deterioration of myelin, a fatty coating that protects neurons and is irreversibly damaged in neurodegenerative diseases such as multiple sclerosis.

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