News from Bioethics.com

African Officials: Monkeypox Spread Is Already an Emergency

1 day 5 hours

(Associated Press) – Monkeypox has been sickening people in parts of central and west Africa for decades, but the lack of laboratory diagnosis and weak surveillance means many cases are going undetected across the continent. To date, countries in Africa have reported more than 1,800 suspected cases so far this year including more than 70 deaths, but only 109 have been lab-confirmed.  (Read More)

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COVID-19 Variant Boosters Won’t Need New Clinical Trials for Clearance, FDA Says

1 day 5 hours

(The Verge) – COVID-19 vaccine manufacturers won’t need to conduct new clinical trials as they develop booster shots targeting the most recent variants of the virus, a Food and Drug Administration official told Reuters. The agency will use clinical trials of variant-specific boosters developed earlier in the pandemic, manufacturing data, and animal studies to evaluate the shots. (Read More)

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WHO: Monkeypox Cases in Europe Have Tripled in Last 2 Weeks

1 day 6 hours

(Associated Press) – The World Health Organization’s Europe chief warned Friday that monkeypox cases in the region have tripled in the last two weeks and urged countries to do more to ensure the previously rare disease does not become entrenched on the continent. (Read More)

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The Fight Over Which Uses of AI Europe Should Outlaw

1 day 6 hours

(Wired) – A ban on AI lie detectors at borders is one of thousands of amendments to the AI Act being considered by officials from EU nations and members of the European Parliament. The legislation is intended to protect EU citizens’ fundamental rights, like the right to live free from discrimination or to declare asylum. It labels some use cases of AI “high-risk,” some “low-risk,” and slaps an outright ban on others. (Read More)

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FDA Planning to Allow Clinical Trials of Pig Organ Transplants

1 day 6 hours

(MIT Technology Review) – The Food and Drug Administration is devising plans to allow clinical trials testing the transplantation of pig organs into humans, a person familiar with the matter said. If the agency follows through, the trials could be a key step in an effort to ease the deadly shortage of human donor organs. The planning comes in the wake of a handful of experimental surgeries involving the transplantation of pig organs into a critically ill man and in brain-dead patients. (Read More)

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Consumers Will Soon Get Access to Huge Amounts of Health Care Price Data

1 day 6 hours

(Axios) – Patients will soon have a clearer picture of what insurers and employers pay for health care thanks to a federal rule that kicks in today — if a collection of health tech companies can make the trove of data understandable. Why it matters: Patients often have no idea what a procedure or service costs — and have little ability to comparison shop — until they’re left holding the bag with a higher bill than they expected. (Read More)

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Monkeypox’s Unusual Spread in Democratic Republic of Congo Puzzles Researchers

2 days 1 hour

(Wall Street Journal) – Monkeypox, which has put the global health community on high alert since emerging recently in dozens of countries world-wide, is also confounding researchers in the Democratic Republic of Congo, a country that has contended with the virus for decades. Researchers in the DRC say that the virus, which has been reported in the Central African nation since 1970, is being found in provinces where it had never before been seen. So far, they don’t know why. (Read More)

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Supreme Court’s Decision on Abortion Sparks Health Tech’s Cambridge Analytica Moment

2 days 1 hour

(STAT News) – In 2018, the tech industry found itself in a harsh spotlight amid a scandal involving a company called Cambridge Analytica, which had collected and used the data of millions of Facebook users, seemingly without their consent. It prompted a public outcry, congressional hearings, a $5 billion fine, and permanently altered the discourse around how social media firms use data. In the wake of a Supreme Court decision overturning Roe v. Wade, health data privacy is getting its own Cambridge Analytica moment. (Read More)

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Pfizer Seeks FDA’s Full Approval for Paxlovid Covid-19 Pill

2 days 1 hour

(Wall Street Journal) – Pfizer Inc. has asked the Food and Drug Administration to grant full approval of its Covid-19 antiviral pill, a step toward allowing the drugmaker to sell the drug commercially. Pfizer said Thursday that it had filed the submission. The FDA typically has 60 days to accept the application and up to 10 months to conduct a review before issuing a decision. To date, Pfizer has been selling the drug, called Paxlovid, to the federal government under an authorization for emergency use. The federal government has then been directing the pills’ distribution. (Read More)

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Tweaked COVID Boosters in US Must Target New Omicron Types

2 days 1 hour

(Associated Press) – U.S. regulators told COVID-19 vaccine makers Thursday that any booster shots tweaked for the fall will have to add protection against the newest omicron relatives. The Food and Drug Administration said the original vaccines would be used for anyone still getting their first series of shots. But with immunity waning and the super-contagious omicron family of variants getting better at dodging protection, the FDA decided boosters intended for fall needed an update. (Read More)

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COVID Vaccine Strategy Still Murky After FDA Experts Meet

2 days 19 hours

(Axios) – The COVID-19 vaccine strategy for the fall remains beset with unanswered questions after an FDA expert panel on Tuesday spent hours debating how and whether to update the shots. Why it matters: Time is running short to develop a game plan with existing vaccines losing effectiveness against new variants and more than half of Americans still without a booster dose. (Read More)

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The Abortion Pill Can Be Used Later Than the FDA Says

2 days 19 hours

(The Atlantic) – The “abortion pill” is a bit of a misnomer. Known formally as medical or medication abortion, it is really two separate drugs—mifepristone, which stops the pregnancy from progressing, followed by misoprostol, which triggers uterus contractions—that together mimic what happens in a miscarriage. And so, in the early days of at-home medication abortion in the 1990s in the U.K. and Sweden, doctors looked to this parallel to establish a cutoff for its use: nine weeks, when a miscarriage is also typically managed safely at home. Over time, however, the line has slowly shifted later into pregnancy. (Read More)

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Norway Was a Pandemic Success. Then It Spent Two Years Studying Its Failures.

2 days 19 hours

(Wall Street Journal) – It turned out that few places outperformed expectations more than Norway.  Not long ago, the World Health Organization published mortality stats from the past two years, which showed that nearly every country’s excess death count spiked during the pandemic. Norway’s barely moved. The Norwegians had pulled off the closest thing possible to an optimal response to the most vexing problems that Covid-19 presented. So how did they do it? As it happens, the Norwegians also wanted to know.  (Read More)

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Tech Giants Pour Billions Into AI, But Hype Doesn’t Always Match Reality

2 days 20 hours

(Wall Street Journal) – After years of companies emphasizing the potential of artificial intelligence, researchers say it is now time to reset expectations. With recent leaps in the technology, companies have developed more systems that can produce seemingly humanlike conversation, poetry and images. Yet AI ethicists and researchers warn that some businesses are exaggerating the capabilities—hype that they say is brewing widespread misunderstanding and distorting policy makers’ views of the power and fallibility of such technology. (Read More)

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South Korea Approves First Homemade COVID-19 Vaccine

2 days 20 hours

(Associated Press) – Health officials in South Korea on Wednesday approved the country’s first domestically developed COVID-19 vaccine for people 18 years or older, adding another public health tool in the fight against a prolonged pandemic. In clinical trials involving some 4,000 participants in South Korea and five other countries, SK Bioscience’s two-dose SKYCovione vaccine appeared to be more effective than the broadly used AstraZeneca shots in building immunity against infections, officials at South Korea’s Food and Drug Safety Ministry said. (Read More)

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TikTok Is Flooded with Health Myths. These Creators Are Pushing Back.

2 days 20 hours

(New York Times) – Misinformation is widespread on all of the major social media platforms, but TikTok’s audio capabilities can give false claims particular longevity. Bits of misinformation clipped and saved as what TikTok calls sounds “operate like viral chain messages,” according to a 2021 blog post from the Institute for Strategic Dialogue, a London-based center that researches disinformation and extremism online. Even if a video is taken down, the original audio often survives in the work of users who have already borrowed it for their own content. (Read More)

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It’s Not Going to Work: Keeping Race Out of Machine Learning Isn’t Enough to Avoid Bias

3 days 22 hours

(STAT News) – As more machine learning tools reach patients, developers are starting to get smart about the potential for bias to seep in. But a growing body of research aims to emphasize that even carefully trained models — ones built to ignore race — can breed inequity in care. Researchers at the Massachusetts Institute of Technology and IBM Research recently showed that algorithms based on clinical notes — the free-form text providers jot down during patient visits — could predict the self-identified race of a patient, even when the data had been stripped of explicit mentions of race. (Read More)

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The Omicron Subvariants BA.4 and BA.5 Have Together Become Dominant in the U.S., the C.D.C. Estimates

3 days 23 hours

(New York Times) – Continuing their rapid march across the United States, the Omicron subvariants known as BA.4 and BA.5 have together become dominant among new coronavirus cases, according to new estimates on Tuesday from the Centers for Disease Control and Prevention. As of the week ending Saturday, BA.4 made up 15.7 percent of new cases, and BA.5 was 36.6 percent, accounting for about 52 percent of new cases in the United States, numbers that experts said should rise in the weeks to come. (Read More)

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Facebook and Instagram Will Remove Posts Offering Abortion Pills

3 days 23 hours

(The Verge) – Facebook and Instagram are removing posts from users that offer help accessing abortion pills, saying they violate a policy around pharmaceuticals. Following the Supreme Court’s overturning of Roe v. Wade on Friday, social media users have shared posts offering to mail abortion pills to people whose access to abortion has been stripped away or will be soon. (Read More)

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FDA Advisers Recommend Updating COVID Booster Shots for Fall

3 days 23 hours

(Associated Press) – Some U.S. adults are a step closer to getting updated COVID-19 boosters this fall, as government advisers voted Tuesday that it’s time to tweak shots to better match the most recent virus variants. The Food and Drug Administration will have to decide the exact recipe but expect a combination shot that adds protection against a version of the super-contagious omicron variant to the original vaccine. (Read More)

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It’s What Beijing’s Party Boss May Not Have Said That Shows Zero-Covid Fatigue

3 days 23 hours

(Wall Street Journal) – Beijing’s top official reportedly pledged five more years of closely following China’s zero-Covid policies, state-run media said Monday, before swiftly removing the reference to how much longer the capital must live with pandemic controls. Not swiftly enough to avoid a storm on social media. Beijing Daily gave no explanation for why it removed the five-year reference from the article, and the phrase couldn’t be heard on a video recording of Communist Party Secretary of Beijing Cai Qi’s speech. (Read More)

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Abortion Providers Sue Idaho, Texas, Mississippi to Stop States’ Trigger Bans

4 days 22 hours

(Axios) – Abortion providers in Idaho, Texas and Mississippi have sued state officials to challenge “trigger” laws scheduled to take effect later in the summer that would make nearly all abortions illegal in those three states. The big picture: These are the most recent lawsuits challenging trigger laws after the Supreme Court overturned Roe v. Wade. So far, suits have been filed in Utah and Louisiana, and the latter’s ban has been temporarily blocked. (Read More)

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Pfizer Says Tweaked COVID-19 Shots Boost Omicron Protection

4 days 22 hours

(Associated Press) – Pfizer announced Saturday that tweaking its COVID-19 vaccine to better target the omicron variant is safe and works — just days before regulators debate whether to offer Americans updated booster shots this fall. (Read More)

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China’s First mRNA Vaccine Is Close–Will That Solve Its COVID Woes?

4 days 22 hours

(Nature) – China is getting closer to approving its first mRNA vaccine to protect people against COVID-19. In a small clinical trial, the Chinese vaccine candidate triggered a stronger antibody response in vaccinated adults when given as a booster shot than did a jab containing inactivated SARS-CoV-2, the vaccine platform that the country has mostly relied on so far. The experimental jab, called ArCoV, is a strong candidate to become China’s first approved mRNA vaccine. But what it would mean for the government’s handling of the pandemic is hard to know, say researchers.  (Read More)

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Mysterious Child Hepatitis Continues to Vex Researchers

4 days 22 hours

(Nature) – In the months since UK physicians sounded the alarm about mysterious cases of hepatitis that seemed to be striking young children, researchers have been scrambling to determine the cause — and a possible connection to the coronavirus pandemic has been among the leading hypotheses. But on 17 June, researchers at the US Centers for Disease Control and Prevention (CDC) published data suggesting that — in the United States, at least — rates of hepatitis, or liver inflammation, with an unknown cause had not changed since 2017 among children aged 11 or younger. If true, the finding could confound the pandemic-link theory. Not everyone is convinced by the data, however, and it is unclear whether the same finding will emerge from other countries. (Read More)

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