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FDA to Warn J&J Vaccine Can Increase Guillain-Barre Risk: Media

July 13, 2021

(Medscape) – People receiving the Johnson and Johnson COVID-19 vaccine could be at increased risk for developing Guillain-Barré syndrome, the US Food and Drug Administration (FDA) is expected to announce as early as tomorrow, according to multiple media reports. Although the FDA is projected to add the new warning to the labeling for the vaccine, the agency still calculates the benefit of vaccination with the J&J product continues to outweigh the risk. Benefits include protection against the Delta variant and serious COVID-19 outcomes. (Read Full Article)

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The U.S. Says Humans Will Always Be in Control of AI Weapons. But the Age of Autonomous War Is Already Here.

July 13, 2021

(The Washington Post) – Drones have been a key part of warfare for years, but they’ve generally been remotely controlled by humans. Now, by cobbling together readily available image-recognition and autopilot software, autonomous drones can be mass-produced on the cheap. Today, efforts to enact a total ban on lethal autonomous weapons, long demanded by human rights activists, are now being supported by 30 countries. But the world’s leading military powers insist that isn’t necessary. The U.S. military says concerns are overblown, and humans can effectively control autonomous weapons, while Russia’s government says true AI weapons can’t be banned because they don’t exist yet. But the facts on the ground show that technological advancements, coupled with complex conflicts like the Syrian and Libyan civil wars, have created a reality where weapons that make their own decisions are already killing people. (Read Full Article)

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Death Toll Rises to 92 in Blaze at Coronavirus Ward in Iraq

July 13, 2021

(Associated Press) – The death toll from a fire that swept through a hospital coronavirus ward climbed to 92 on Tuesday, Iraq’s state news agency reported, as anguished relatives buried their loved ones and lashed out at the government over the country’s second such disaster in less than three months. Health officials said scores of others were injured in the blaze that erupted Monday at al-Hussein Teaching Hospital in Nasiriyah. The tragedy cast a spotlight on what many have decried as widespread negligence and mismanagement in Iraq’s hospitals after decades of war and sanctions. (Read Full Article)

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J&J’s Covid-19 Vaccine May Trigger Neurological Condition in Rare Cases, FDA Says

July 12, 2021

(STAT News) – Johnson & Johnson’s Covid-19 vaccine may trigger a rare neurological condition in a small number of people who receive the vaccine, the Food and Drug Administration said Monday. Reports to a database operated jointly by the agency and the Centers for Disease Prevention and Control suggest there may be a link between the inoculations and Guillain-Barré syndrome, a form of progressive paralysis that is generally reversible, the FDA said in a statement. (Read Full Article)

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Why We May Never Know Whether the $56,000-a-Year Alzheimer’s Drug Actually Works

July 12, 2021

(Kaiser Health News) – The Food and Drug Administration’s approval in June of a drug purporting to slow the progression of Alzheimer’s disease was widely celebrated, but it also touched off alarms. There were worries in the scientific community about the drug’s mixed results in studies — the FDA’s own expert advisory panel was nearly unanimous in opposing its approval. And the annual $56,000 price tag of the infusion drug, Aduhelm, was decried for potentially adding costs in the tens of billions of dollars to Medicare and Medicaid. But lost in this discussion is the underlying problem with using the FDA’s “accelerated” pathway to approve drugs for conditions such as Alzheimer’s, a slow, degenerative disease. Though patients will start taking it, if the past is any guide, the world may have to wait many years to find out whether Aduhelm is actually effective — and may never know for sure. (Read Full Article)

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The Rationing of a Last-Resort Covid Treatment

July 12, 2021

(New York Times) – Throughout the pandemic, such scenes have played out across the country as American doctors found themselves in the unfamiliar position of overtly rationing a treatment. But it was not ventilators, as initially feared: Concerted action largely headed off those shortages. Instead, it was the limited availability of ECMO — which requires expensive equipment similar in concept to a heart-lung machine and specially trained staff who can provide constant monitoring and one-on-one nursing — that forced stark choices among patients. (Read Full Article)

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Human Genome Editing: Recommendations

July 12, 2021

(WHO) – The recent application of tools, such as CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats; Cas9 nuclease), to edit the human genome with the intention of treating or preventing disease and the gaps in our scientific understanding, in addition to some of the proposed applications of human genome editing, raise ethical issues that have highlighted the need for robust oversight in this area In December 2018, WHO established a global, multidisciplinary expert advisory committee (the Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, hereafter called the Committee) to examine the scientific, ethical, social and legal challenges associated with human genome editing (somatic, germline and heritable). The governance framework on human genome editing, along with the recommendations of the Committee, form a set of two publications that provide advice and recommendations on appropriate institutional, national, regional and global governance mechanisms for human genome editing. A position paper on human genome editing provides a summary of these two publications. (Read Full Article)

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After Backlash, Predictive Policing Adapts to a Changed World

July 12, 2021

(Wall Street Journal) – It was a seductive pitch to city governments and police departments: Use predictive software to deter crime before it is committed. Artificial intelligence-powered algorithms, the software companies said, could chew up data on incident reports, weather, time and other variables, learn historical patterns, and spit out forecasts faster, cheaper and more accurately than human analysts. Using big data to put cops in the right place at the right time would help discourage crime. Federal funding helped push such tools to police departments in Los Angeles, New York and elsewhere in the 2010s. More recently, however, those tools have faced pushback. (Read Full Article)

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Prisoners, Doctors, and the Battle Over Trans Medical Care

July 12, 2021

(Wired) – An oddity of medical care in the US is that access to it is a constitutional right—at least on paper—for a single category of Americans: the incarcerated. Courts have long interpreted the Eighth Amendment’s guarantee against cruel and unusual punishment to mean that prisons must provide “adequate” and “medically necessary” care. Over the past 20 years, transgender prisoners have argued in lawsuits that gender-affirming hormone therapy and surgery should qualify.  (Read Full Article)

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In Children, Risk of Covid-19 Death or Serious Illness Remains Extremely Low, New Studies Find

July 12, 2021

(Wall Street Journal) – Children are at extremely slim risk of dying from Covid-19, according to some of the most comprehensive studies to date, which indicate the threat might be even lower than previously thought. Some 99.995% of the 469,982 children in England who were infected during the year examined by researchers survived, one study found. In fact, there were fewer deaths among children due to the virus than initially suspected. Among the 61 child deaths linked to a positive Covid-19 test in England, 25 were actually caused by the illness, the study found. (Read Full Article)

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CDC and Pfizer at Odds Over Need for COVID-19 Booster Shots

July 12, 2021

(Medscape) – Shortly after Pfizer announced its intention to seek FDA authorization for a third COVID-19 vaccine shot on Thursday, the CDC, FDA, and NIH countered with a joint statement the same day saying, essentially, it’s still too soon. In a battle of the booster shot statements, the vaccine manufacturer and the US government are drawing very different conclusions based on the evidence to date. (Read Full Article)

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FDA Calls for Federal Investigation Into Its Controversial Alzheimer’s Drug Approval

July 9, 2021

(STAT News) – The head of the Food and Drug Administration has called for a wide-ranging federal investigation into the approval of Biogen’s treatment for Alzheimer’s disease just one month after a decision that sparked the ire of lawmakers, doctors, and public health advocates. In a letter posted Friday, Acting Commissioner Janet Woodcock asked the independent Office of the Inspector General to investigate how agency staff interacted with Biogen in the run-up to the June 7 approval of Aduhelm. The agency cited STAT’s reporting that FDA officials worked hand in hand with Biogen executives to get the drug on the market, including an off-the-books meeting and an unprecedented decision to approve Aduhelm through a regulatory shortcut. (Read Full Article)

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Russia Allows U.N. Syria and Access from Turkey for 12 Months

July 9, 2021

(Reuters) – The U.N. Security Council agreed on Friday to extend a cross-border aid operation into Syria from Turkey after Russia agreed to a compromise in last minute talks with the United States that ensures U.N. aid access to millions of Syrians for 12 months. “Parents can sleep tonight knowing that for the next 12 months their children will be fed. The humanitarian agreement we’ve reached here will literally save lives,” said U.S. Ambassador to the United Nations, Linda Thomas-Greenfield. (Read Full Article)

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Gene Hunters Turn Up New Clues to Help Explain Why Covid-19 Hits Some People So Hard

July 9, 2021

(STAT News) – On March 16, 2020, five days after the World Health Organization declared Covid-19 a global pandemic, Andrea Ganna, a geneticist at the Institute for Molecular Medicine Finland, took to Twitter to make an announcement: “We are launching the ‘COVID-19 host genetics initiative,’” he wrote. He asked other scientists to join him and institute director Mark Daly in probing the world’s stores of human DNA to help answer a complicated but pressing question: Why do some unlucky people infected by the coronavirus end up gasping for air in an intensive care unit, while many others catch and spread the disease without having so much as a cough? Ganna wasn’t quite prepared for how many would take him up on the offer. Over the last 15 months, more than 3,300 researchers from 25 countries have poured data from millions of people, including more than 125,000 Covid-19 patients, into the initiative, making it one of the largest gene-hunting missions in history. (Read Full Article)

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Doctors Might Have Been Focusing on the Wrong Asthma Triggers

July 9, 2021

(The Atlantic) – Asthma experts I spoke with all agreed that reduced viral exposure likely played a part in the drop, but the pandemic changed so many things at once that other factors are hard to rule out. Staying at home might have made it easier for people to keep up with their regular long-term asthma medication. They were also no longer exposed to potential triggers at work or school, such as diesel from school buses or chemicals in cleaning products. Asthma can be very individual, with exact triggers varying from person to person. But the overall picture is impossible to ignore: The sweeping changes to our social lives during the pandemic made asthma a lot easier to control. (Read Full Article)

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Can We Stretch Existing Covid Vaccines to Inoculate More People? Experts Are Divided

July 9, 2021

(STAT News) – With the global supply of Covid-19 vaccine still woefully inadequate, vaccine makers are scouring the pharmaceutical landscape for partners to ramp up manufacturing, and civil society groups are pressing politicians to waive intellectual property protections in a bid to spur still more production. But what if there was a simpler way? What if current supplies could be stretched, to vaccinate more people more quickly? What if the world is using more vaccine than it needs to on each person immunized, depriving people in the queue of a chance to be protected? Reducing the size of a vaccine dose is an approach that has been used successfully before and ought to be explored, some scientists argue. (Read Full Article)

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FDA Trims Use of Contentious Alzheimer’s Drug Amid Backlash

July 9, 2021

(Associated Press) – A month after approving a controversial new Alzheimer’s drug, U.S. health regulators on Thursday signed off on new prescribing instructions that are likely to limit its use. The Food and Drug Administration said the change is intended to address confusion among physicians and patients about who should get the drug, which has faced an intense public backlash since its approval last month. (Read Full Article)

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New Online Calculator Can Predict How Long Seniors Have Left to Live, What Help They Need

July 7, 2021

(Global News) – Amid a lack of proper support for Canadians receiving home-based support towards the end of their lives, a new risk calculator is helping predict how long seniors have left to live. The Risk Evaluation for Support: Predictions for Elder-Life in the Community Tool — dubbed ‘RESPECT’ for short — can predict death within six months, and was developed using data from more than 491,000 community-dwelling adults aged at least 50 years who used home care between 2007 and 2013. (Read Full Article)

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‘Too Good to Be True’: Doubts Swirl Around Trial That Saw 77% Reduction in COVID-19 Mortality

July 7, 2021

(Science) – It would be the best news by far in COVID-19 treatment: According to a preprint published on 22 June, an experimental prostate cancer drug named proxalutamide reduced deaths in hospitalized COVID-19 patients by 77% in a clinical trial in Brazil. The preprint also claims the drug, which blocks the activity of androgens—male hormones such as testosterone—cut patients’ average hospital stay by 5 days, far more than any other treatment yet tested. Interim results of the study, announced at a press conference in March, led President Jair Bolsonaro to tout proxalutamide as a wonder cure and spurred Brazilian doctors to dose patients with similar drugs. But many scientists are wary. Alleged irregularities in the clinical trial have reportedly triggered an investigation by a national research ethics commission in Brazil. (Read Full Article)

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Covid-19 Vaccine-Related Blood Clots Linked to Amino Acids in New Study

July 7, 2021

(Wall Street Journal) – Canadian researchers say they have pinpointed a handful of amino acids targeted by key antibodies in the blood of some people who received AstraZeneca PLC’s AZN -0.23% Covid-19 vaccine, offering fresh clues to what causes rare blood clots associated with the shot. The peer-reviewed findings, by a team of researchers from McMaster University in Ontario, were published online Wednesday by the science journal Nature. They could help doctors rapidly test for and treat the unusual clotting, arising from an immune-driven mix of coagulation and loss of platelets that stop bleeding. (Read Full Article)

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