News from Bioethics.com

FDA’s Own Documents Reveal Agency’s Law, Slow, and Secretive Oversight of Clinical Research

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(Science) – Through all that, FDA never formally sanctioned Harris or pursued other penalties. The agency never made public the alleged offenses or told trial participants they might have been put at risk. Nor did it tell companies sponsoring some of the trials that their data might have been compromised. (The documents Science obtained were heavily redacted, making it impossible to know which trials were in doubt and, thus, which volunteers might have been harmed or endangered.) Meanwhile, pharmaceutical and medical device companies continued to contract with Aspen.

To Free Doctors from Computers, Far-Flung Scribes Are Now Taking Notes for Them

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(Kaiser Health News) – Medical scribes first appeared in the 1970s as note takers for emergency room physicians. But the practice took off after 2009, when the federal HITECH Act incentivized health care providers to adopt EHRs. These were supposed to simplify patient record-keeping, but instead they generated a need for scribes. Doctors find entering notes and data into poorly designed EHR software cumbersome and time-consuming. So scribing is a fast-growing field in the U.S., with the workforce expanding from 15,000 in 2015 to an estimated 100,000 this year.

Self-Medication Increases Pandemic Deaths in Peru

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(The Economist) – LUIS ESPINOZA has been battling covid-19 in Peru since March. A doctor specialising in tropical medicine and infectious diseases, he was sent by the health ministry to Iquitos, in the northern jungle, when the pandemic began, then moved to Sullana, a sweltering northern city. Both cities have high numbers of deaths from covid-19. Many, says Dr Espinoza, were avoidable. “Patients who should not be dying are dying because of complications caused by self-medicating,” he says. That may help explain why Peru has had more deaths from the disease as a share of its population than all but one other country.

Web of ‘Wellness’ Doctors Promote Injections of Unproven Coronavirus Treatment

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(NPR) – An NPR investigation has found that Fradin-Read’s practice is one of more than 30 medical practices and compounding pharmacies across more than a dozen states that have made unproven claims about this drug on their websites and on social media. It remains unclear how many Americans may have taken the drug since the pandemic began, though one doctor told NPR that she had prescribed it to more than 100 patients. The cost of the drug can run up to $400 for a month’s supply — all out of pocket.

Can the U.S. Use Its Growing Supply of Rapid Tests to Stop the Virus

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(NPR) – Until now, testing has been primarily used to diagnose people who may have COVID-19 and any of their close contacts who may also be infected. But a stubborn shortage of the molecular tests most commonly used — and slow turnaround time for results — has hobbled the nation’s ability to stop outbreaks and contain the pandemic. That could change, argue Jha and other public health researchers, as new rapid tests — primarily antigen tests — become more widely available, enabling communities to start widespread screening of the highest-risk people.

‘Provocative Results’ Boost Hopes of Antibody Treatment for COVID-19

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(Science) – A second company has now produced strong hints that monoclonal antibodies, synthetically produced versions of proteins made by the immune system, can work as treatments in people who are infected with the pandemic coronavirus but are not yet seriously ill. The biotech Regeneron Pharmaceuticals has developed a cocktail of two monoclonal antibodies that attach to the surface protein of that coronavirus, SARS-CoV-2, and attempt to block it from infecting cells. Yesterday at an investor and media webcast, the firm revealed early results.

Huge Study of Coronavirus Cases in India Offers Some Surprises to Scientists

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(The New York Times) – With 1.3 billion people jostling for space, India has always been a hospitable environment for infectious diseases of every kind. And the coronavirus has proved to be no exception: The country now has more than six million cases, second only to the United States. An ambitious study of nearly 85,000 of those cases and nearly 600,000 of their contacts, published Wednesday in the journal Science, offers important insights not just for India, but for other low- and middle-income countries.

Post-COVID Clinics Get Jump-Start from Patients with Lingering Illness

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(Kaiser Health News) – As the election nears, much attention is focused on daily infection numbers or the climbing death toll, but another measure matters: Patients who survive but continue to wrestle with a range of physical or mental effects, including lung damage, heart or neurological concerns, anxiety and depression. “We need to think about how we’re going to provide care for patients who may be recovering for years after the virus,” said Dr. Sarah Jolley, a pulmonologist with UCHealth University of Colorado Hospital and director of UCHealth’s Post-Covid Clinic, where Troutman is seen.

Corralling the Facts on Herd Immunity

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(Medscape) – For a term that’s at least 100 years old, “herd immunity” has gained new life in 2020. It starred in many headlines last month, when reports surfaced that a member of the White House Coronavirus Task Force and adviser to the president, Dr. Scott Atlas, recommended it as a strategy to combat COVID-19. The Washington Post reported that Atlas, a health care policy expert from the Hoover Institution of Stanford University, suggested the virus should be allowed to spread through the population so people build up immunity, rather than trying to contain it through shutdown measures.

Moderna COVID-19 Vaccine Appears Safe, Shows Signs of Working in Older Adults: Study

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(Reuters) – Results from an early safety study of Moderna Inc’s MRNA.O coronavirus vaccine candidate in older adults showed that it produced virus-neutralizing antibodies at levels similar to those seen in younger adults, with side effects roughly on par with high-dose flu shots, researchers said on Tuesday. The study, published in the New England Journal of Medicine, offers a more complete picture of the vaccine’s safety in older adults, a group at increased risk of severe complications from COVID-19.

‘Testing Hell’: Gift of Devices to Nursing Homes Brings New Problems

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(New York Times) – The hand-held testing devices, which spit out results in as little as 15 minutes, were intended to quickly diagnose and isolate patients, and alter the deadly calculus of a contagion that has taken the lives of 77,000 nursing home residents and workers, more than 40 percent of the nation’s fatalities from Covid-19. But the initial sense of relief has been overtaken by frustration as nursing homes have discovered that they must pay for test kits on their own, and that the machines are markedly less accurate than lab-based diagnostics.

World Bank Announces $12bn Plan for Poor Countries to Buy Covid Vaccines

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(The Guardian) – The World Bank has announced plans for a $12bn (£9.3bn) initiative that will allow poor countries to purchase Covid-19 vaccines to treat up to 2 billion people as soon as effective drugs become available. In an attempt to ensure that low-income countries are not frozen out by wealthy nations, the organisation is asking its key rich-nation shareholders to back a scheme that will disburse cash over the next 12 to 18 months.

Alexa, Do I Have COVID-19?

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(Nature) – Vocalis, a voice-analysis company with offices in Israel and the United States, had previously built a smartphone app that could detect flare-ups of chronic obstructive pulmonary disease by listening for signs that users were short of breath when speaking. The firm wanted to do the same thing with COVID-19. People who had tested positive for the coronavirus could participate simply by downloading a Vocalis research app. Once a day, they fired up the app and spoke into their phones, describing an image aloud and counting from 50 to 70.

COVID Has Killed More Than One Million People. How Many More Will Die?

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(Nature) – Nine months into the coronavirus pandemic, the official global death toll has now exceeded one million people. But researchers warn that this figure probably vastly underestimates the actual number of people who have died from COVID-19. And, in a worst-case scenario, one group of modellers suggests that the number of deaths could exceed 3 million people by January.

COVID-19 Cases Rising Among US Children as Schools Reopen

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(Associated Press) – After preying heavily on the elderly in the spring, the coronavirus is increasingly infecting American children and teens in a trend authorities say appears driven by school reopenings and the resumption of sports, playdates and other activities. Children of all ages now make up 10% of all U.S cases, up from 2% in April, the American Academy of Pediatrics reported Tuesday.

WHO to Probe ‘Sexual Exploitation’ by Aid Workers in DR Congo

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(BBC) – The World Health Organization (WHO) has pledged to investigate allegations that aid workers tackling the Ebola outbreak in the Democratic Republic of Congo sexually abused and exploited women. WHO and other aid agency staff were accused by 50 women in a joint investigation by two news agencies. Local women were allegedly plied with drinks, “ambushed” in hospitals, forced to have sex, and two became pregnant.

Regeneraon’s Covid-19 Antibody May Help Non-Hospitalized Patients Recover Faster, Early Data Show

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(STAT News) – New data from the biotechnology firm Regeneron seem likely to add to the excitement about drugs called monoclonal antibodies as treatments for Covid-19, but experts caution more data will be needed to know how potentially beneficial the medicines are. A high dose of the company’s antibody cocktail, REGN-COV2, led levels of the virus to decrease more quickly in infected, non-hospitalized patients, potentially indicating the treatment may help them get better, Regeneron reported Tuesday via press release. Full results will be published at a later date.

WHO, Partners Roll Out Faster COVID Tests for Poorer Nations

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(Associated Press) – The World Health Organization announced Monday that it and leading partners have agreed to a plan to roll out 120 million rapid-diagnostic tests for the coronavirus to help lower- and middle-income countries make up ground in a testing gap with richer countries — even if it’s not fully funded yet.

Worldwide Death Toll from Coronavirus Eclipses 1 Million

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(Associated Press) – The worldwide death toll from the coronavirus has eclipsed 1 million, nine months into a crisis that has devastated the global economy, tested world leaders’ resolve, pitted science against politics and forced multitudes to change the way they live, learn and work.

A Ransomware Attack Has Struck a Major US Hospital Chain

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(Wired) – Universal Health Services, a hospital and health care network with more than 400 facilities across the United States, Puerto Rico, and United Kingdom, suffered a ransomware attack early Sunday morning that has taken down its digital networks at locations around the US. As the situation has spiraled, some patients have reportedly been rerouted to other emergency rooms and facilities and had appointments and test results delayed as a result of the attack. 

The UK Could Be the First Country to Intentionally Give People Coronavirus to Test Vaccines

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(Gizmodo) – The UK is considering a controversial approach to testing potential vaccines for the coronavirus that causes covid-19: intentionally exposing volunteers to the virus, in a strategy known as challenge trials. Last week, the Financial Times reported that the UK government will allow human challenge vaccine trials to begin by January 2021. In these trials, volunteers would be given an experimental vaccine and then later exposed to the coronavirus in a controlled setting.

New Document Reveals Scope and Structure of Operation Warp Speed and Underscores Vast Military Involvement

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(STAT News) – Operation Warp Speed’s central goal is to develop, produce, and distribute 300 million doses of a coronavirus vaccine by January — and the military is intimately involved, according to Paul Mango, HHS’ deputy chief of staff for policy. It has already helped prop up more than two dozen vaccine manufacturing facilities — flying in equipment and raw materials from all over the world. It has also set up significant cybersecurity and physical security operations to ensure an eventual vaccine is guarded very closely from “state actors who don’t want us to be successful in this,” he said, adding that many of the Warp Speed discussions take place in protected rooms used to discuss classified information.

Covid-19 Tests That Give Results in Minutes to Be Rolled Out Across World

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(The Guardian) – Tests for Covid-19 that show on-the-spot results in 15 to 30 minutes are about to be rolled out across the world, potentially saving many thousands of lives and slowing the pandemic in both poor and rich countries. In a triumph for a global initiative to get vital drugs and vaccines to fight the virus, 120m rapid antigen tests from two companies will be supplied to low- and middle-income countries for $5 (£3.90) each or even less.

Novavax Researcher Says No Chance of a ‘Shortcut’ in Vaccine Safety

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(NPR) – Novavax, a vaccine maker in Maryland, is becoming the 10th coronavirus vaccine candidate to enter the final phase of testing, called phase 3. The trial is taking place in the U.K., where researchers plan to enroll up to 10,000 adults of various ages in the next four to six weeks. Half the participants will get a placebo and half will get the company’s vaccine. At least a quarter of participants will be over the age of 65, the company says, and it will also “prioritize groups that are most affected by COVID-19, including racial and ethnic minorities.”

‘There Is a Fear That This Will Eradicate Dwarfism’: The Controversy Over a New Growth Drug

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(The Guardian) – The treatment is in its “early days”, but she believes that it is potentially life-changing. It is also a treatment that is the subject of division within the dwarfism community, with many believing that achondroplasia, along with other forms of dwarfism, is not something to be “fixed”. Earlier this month, the results of the phase-three study of vosoritide, the drug Samuel takes, were published in the medical journal the Lancet (the previous phase established that it was safe). Covering several countries, with 119 children taking part, it found that those taking the drug for a year grew faster than those on a placebo.

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