News from Bioethics.com

Major Hydroxychloroquine Trial Shows No Prevention Benefits

2 months 4 days

(Wired) – The drug hydroxychloroquine, touted by President Donald Trump and his allies as a treatment and preventative for the pandemic disease Covid-19, does not keep people from getting sick. A large, randomized study, scheduled to appear today in The New England Journal of Medicine shows that the drug is no better than a placebo at preventing infection in people exposed to the virus under real-world conditions. This was a careful, well-planned trial—one of the most rigorous tests of hydroxychloroquine yet completed.

Thousands of People Will Help Scientists to Track the Long-Term Health Effects of the Coronavirus Crisis

2 months 5 days

(Nature) – The effort, led by epidemiologist Monique Breteler, is one of several long-term cohort studies that originally focused on other diseases but have swiftly been repurposed to study the coronavirus. Population cohorts collect genetic, health and lifestyle information from thousands of people over years or even decades to find out which genetic and environmental factors collude to increase risk of diseases. The Rhineland Study, for instance, was set up in 2016 to study neurodegenerative disorders, such as Alzheimer’s disease.

Scientists Question Medical Data Used in Second Coronavirus Study

2 months 5 days

(New York Times) – Since the outbreak began, researchers have rushed to publish studies about the new coronavirus spreading swiftly through the world. On Tuesday, for the second time in recent days, a group of scientists has questioned the data used in studies in two prominent medical journals. A group of scientists who raised questions last week about a study in The Lancet about the use of antimalarial drugs in coronavirus patients have now objected to another paper about blood pressure medicines in the New England Journal of Medicine, which was published by some of the same authors and relied on the same data registry.

Racism Is a Public Health Issue and ‘Police Brutality Must Stop,’ Medical Groups Say

2 months 5 days

(CNN) – As protests over George Floyd’s death continue nationwide, several doctors’ groups — the American Academy of Pediatrics, American Medical Association and American College of Physicians — are emphasizing that racism is a public health issue and they’re calling for police brutality to stop. The American Academy of Pediatrics posted to Twitter on Sunday night that “racism is a public health issue,” and the tweet linked to the AAP’s 2019 policy statement about the impact of racism on child and adolescent health.

What Norma McCorvey Believed Matters

2 months 5 days

(The Atlantic) – Last weekend, FX premiered AKA Jane Roe, a documentary on Norma McCorvey, the plaintiff in Roe v. Wade. Backers of the film touted its most explosive revelation—that McCorvey, Jane Roe herself, had converted to the anti-abortion cause only because she was getting paid. This news made waves, and the attention it received has raised, in turn, a bigger question: Why does it matter at all what she really thought about abortion? The constitutional-law expert Michael Dorf has argued that it doesn’t—or at least that clashing social movements have blown its significance way out of proportion. He contends that when it comes to the ultimate fate of abortion rights, McCorvey’s beliefs matter very little. That may be right legally, but McCorvey—and making sense of her—remains central to the abortion debate, and the reason is obvious: Her story has come to stand in for the greater question of whether abortion is good for women—a question the Supreme Court is likely to rule on by the end of next month.

Bioethicist: ‘Immunity Passports’ Could Do More Harm Than Good

2 months 6 days

(NPR) – “Immunity passports” have been proposed as one way to reboot economies in the wake of the coronavirus pandemic. The theory is this: The approval of the so-called passports would rely on the positive results from an antibody test of your collected blood sample. If you have antibodies to the coronavirus after recovering from an infection, you might be immune from future infection and therefore could be authorized to work and circulate in society without posing a risk to yourself or others. At least, that’s the idea. But it “could create a lot more harm than it does good,” says Natalie Kofler, who teaches bioethics at Harvard Medical School.

Principles in the Nuremberg Code Are Compatible with Vaccination

2 months 6 days

(AFP) -Facebook and Instagram posts shared thousands of times claim that vaccines directly violate the Nuremberg Code, a set of research ethics principles for human experimentation established after World War II. This claim is false; medical ethics and legal experts said the principles, named after the Nuremberg trials, are compatible with vaccination. “Vaccines are in direct violation of the Nuremberg Code,” a flyer photographed and shared on Facebook in Canada on May 25, 2020 warns.

End-of-Life Care Disrupted in COVID-19 Crisis

2 months 6 days

(Medscape) – Disruptions to end-of-life care have become all too common during COVID-19, with some patients even being separated from loved ones at the time of their death. “We’ve had patients pass away in the hospital, not from COVID, and the bereavement and the inability to have closure at the end of life is really difficult,” said Joshua Uy, MD, a geriatrician at Penn Medicine in Philadelphia. “People feel guilty that they couldn’t be with their loved ones or are just angry that this pandemic has separated them from their loved ones at the end of life,” he told Medscape Medical News.

European Government Officials Call for Tech Companies to Loosen Grip on Contact Tracing Technology

2 months 1 week

(The Washington Post) – Five European nations this week signed a joint letter calling on major technology companies to offer more flexibility in allowing them to design and implement contact tracing and warning applications, adding to a growing chorus of public health and medical officials asking for similar concessions. The calls come as Apple and Google have limited access to data and the usability of their app-development technology to their usual rules — even when related to coronavirus, something some have complained has limited the effectiveness of what they’ve designed.

FDA Finds Contamination in Several Brands of Diabetes Drug

2 months 1 week

(ABC News) – U.S. health regulators are telling five drugmakers to recall their versions of a widely used diabetes medication after laboratory tests found elevated levels of a contaminant linked to cancer. The Food and Drug Administration said late Thursday that several batches of the drug metformin tested positive for unsafe levels of a chemical called N-Nitrosodimethylamine.

Hunger, Infection, and Repression: Venezuela’s Coronavirus Calamity

2 months 1 week

(The New Yorker) – “Fear took hold of every one of us,” González recalled. Many people around her broke into tears. Others asked how a country where most hospitals lack running water, electricity, and soap could combat such an illness. González’s thoughts drifted away from the meeting room. She feared for her seventy-year-old mother, who suffers from hypertension; her three children, ages twenty-one, eighteen, and eleven; and her granddaughter, who has been in González’s charge since her daughter-in-law fled to Peru, in search of work. With a joint income of ten dollars per month, González and her partner support the entire family. Sheltering in place was not an option for them, nor for millions in Venezuela, a country where the poor line up outside slaughterhouses to fill buckets with cow blood, the only protein they can afford.

European, South Korean Authorities Vie for COVID-19 Antiviral Remdesivir

2 months 1 week

(Reuters) – European and South Korean authorities are vying for Gilead Sciences’ (GILD.O) potential COVID-19 treatment, remdesivir, even though the drugmaker has yet to gain regulatory approval in either market and is still ramping up production of the anti-viral drug. Governments are racing to bolster supplies of remdesivir, which U.S. regulators greenlighted this month as a treatment for the novel coronavirus. Foster City, California-based Gilead said it will donate 1.5 million doses of remdesivir, enough to treat at least 140,000 patients, to combat the global pandemic. 

Exclusive: Sanofi Stops Enrolling COVID-19 Patients in Hydroxychloroquine Trials

2 months 1 week

(Reuters) – Sanofi has temporarily stopped recruiting new COVID-19 patients for two clinical trials on hydroxychloroquine and will no longer supply the anti-malaria drug to treat COVID-19 until concerns about safety are cleared up, it said on Friday.  The moves come after the World Health Organization paused its large trial of hydroxychloroquine, prompting several European governments to ban the use of the drug, also used in rheumatoid arthritis and lupus.

Big Gene Therapy Names Line Up Behind Experimental Covid-19 Vaccine

2 months 1 week

(STAT News) – An early stage vaccine against Covid-19 based on the same basic technology used in gene therapy is gaining some support from some of that field’s biggest names. Earlier this year, James Wilson, a gene therapy pioneer, got a call from Luk Vandenberghe, who had been a graduate student in Wilson’s lab two decades ago. Vandenberghe wondered if a virus they had worked on as a potential component of gene therapies might work as part of a vaccine against SARS-CoV-2, the coronavirus that causes Covid-19.

Suits Accuse Retail Chains of Flooding Ohio with Painkillers

2 months 1 week

(ABC News) – Five retail chains flooded two Ohio counties with tens of millions of prescription painkillers through their pharmacies while taking few if any steps to stop drugs from being illegally diverted, according to updated lawsuits unsealed in U.S. District Court in Cleveland. The counties are Lake and Trumbull in northeast Ohio. Their lawsuits made public Wednesday allege CVS, Walgreens, Rite Aid, Walmart and Giant Eagle helped fuel a national drug crisis that resulted in more than 430,000 deaths since 2000.

Great Plains Indian Reservations Report 17% Spike in COVID-19 Cases

2 months 1 week

(UPI) – American Indian tribal reservations in the Great Plains region of the United States have seen a 17 percent uptick in confirmed COVID-19 cases in the past week, researchers said. The data is “shining a light” on disparities in overall health and access to care in these communities, Dr. Donald Warne, an expert in Indian health issues said Thursday.

Cancer, Coronavirus Are a Dangerous Mix, New Studies Find

2 months 1 week

(ABC News) – New research shows how dangerous the coronavirus is for current and former cancer patients. Those who developed COVID-19 were much more likely to die within a month than people without cancer who got it, two studies found. They are the largest reports on people with both diseases in the United States, the United Kingdom, Spain and Canada. In one study, half of 928 current and former cancer patients with COVID-19 were hospitalized and 13% died. That’s far more than the various rates that have been reported in the general population.

Today’s High Potency Weed Raises Risk of Anxiety and Addiction, Study Says

2 months 1 week

(CNN) – If you’re thinking of returning to the weed of your youth to ease the strain of the pandemic, you will soon discover a potent truth — today’s weed is nothing like yesterday’s.  Just 20 years ago levels of tetrahydracannabinol, the compound in cannabis known as THC that makes you high, was between 2% and 4% in most marijuana. By 2013, common strains contained 25% THC, with some testing as high as 37%. Use of weed of any strength has been linked to mental health disorders, and lab experiments have shown that higher does of THC can cause greater memory impairment and temporary psychotic-like symptoms. But few studies have examined how potency levels may affect behavior in real-world populations.

Experts Decry FDA’s Halting of a High-Profile Covid-19 Study Over Approvals

2 months 1 week

(STAT News) – Regulators at the Food and Drug Administration told STAT the agency’s decision this month to halt a high-profile, Bill Gates-backed effort to study the spread of coronavirus in the Seattle area came after the researchers involved failed to secure needed approval. The program, called the Seattle Coronavirus Assessment Network, or SCAN, was initially focused on studying the flu but quickly pivoted to track the coronavirus at the outset of the pandemic, making inroads in tracking the spread of the virus and attracting high-profile support from companies like shipping giant Amazon, whose health care arm picked up and delivered Covid-19 tests to healthy and infected people. But the FDA stopped the effort suddenly last week, the New York Times reported.

British Regulator Says ‘COPCOV’ Hydroxychloroquine Trial Paused

2 months 1 week

(Reuters) – An international hydroxychloroquine trial led by the University of Oxford has been paused, Britain’s pharmaceutical regulator said on Wednesday, less than a week after the trial started, amid fresh safety concerns over the drug.  The French government on Wednesday cancelled a decree allowing hospital doctors to administer hydroxychloroquine as a treatment to patients suffering severe forms of COVID-19, the illness caused by the new coronavirus. 

Chile’s Hospital ICUs Near Full Capacity as Pandemic Rages

2 months 1 week

(ABC News) – Intensive care units in Chile’s hospitals are nearly at capacity amid a flood of coronavirus patients, authorities said Tuesday, and doctors are having to make wrenching choices over which patients should get available beds. Health officials said 95% of the country’s 2,400 ICU beds are occupied even after a doubling of capacity from the levels in March. They announced plans to add 400 more critical care beds in the coming days.

As Covid-19 Tears Through Navajo Nation, Young People Step Up to Protect Their Elders

2 months 1 week

(STAT News) – In recent weeks, similar messages have resounded across the Navajo Nation, as younger generations have come to play a pivotal grassroots role in the pandemic response. They have moved quickly for good reason. Navajo residents have been devastated as the virus has swept through a reservation that spans four states. Already, 4,633 people have tested positive for the coronavirus, and 153 have died as of May 23, a staggering toll in a population of 356,000 — and the highest infection rate of anywhere in the U.S. Young Navajos are motivated, in large part, by a desire to protect their elders — many of whom have underlying health conditions and who are at high risk of Covid-19 — and the vital cultural knowledge they carry.

He Experienced a Severe Reaction to Moderna’s Covid-19 Vaccine Candidate. He’s Still a Believer

2 months 1 week

(STAT News) – Patients in clinical trials are usually faceless. But as the experimental Covid-19 vaccine being developed by Moderna Therapeutics has begun advancing through studies, it has found a much more visible advocate: trial volunteer Ian Haydon, a 29-year-old in Seattle. Haydon has spoken about the vaccine on CNN and CNBC. He even said he’d volunteer to be exposed to the novel coronavirus, SARS-CoV-2, if researchers want to test to see if the vaccine was actually effective. But up until now he has left out a key detail: He is, apparently, one of three people in the trial who had a systemic adverse reaction to the vaccine. 

New Research Rewrites History of When Covid-19 Arrived in U.S.–And Points to Missed Chances to Stop It

2 months 1 week

(STAT News) – New research has poured cold water on the theory that the Covid-19 outbreak in Washington state — the country’s first — was triggered by the very first confirmed case of the infection in the country. Instead, it suggests the person who ignited the first chain of sustained transmission in the United States probably returned to the country in mid-February, a month later. The work adds to evidence that the United States missed opportunities to stop the SARS-CoV-2 virus from taking root in this country — and that those opportunities persisted for longer than has been recognized up until now.

Study Tells ‘Remarkable Story’ About COVID-19’s Deadly Rampage Through a South African Hospital

2 months 1 week

(ABC News) – Now, scientists at the University of KwaZulu-Natal have published a detailed reconstruction of how the virus spread from ward to ward and between patients, doctors, and nurses, based on floor maps of the hospital, analyses of staff and patient movements, and viral genomes. Their 37-page analysis, posted on the university’s website on 22 May, is the most extensive study of any hospital outbreak of COVID-19 so far. It suggests all of the cases originated from a single introduction, and that patients rarely infected other patients. Instead, the virus was mostly carried around the hospital by staff and on the surfaces of medical equipment.

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