News from Bioethics.com

First Proven Malaria Vaccine Rolled Out in Africa–But Doubts Linger

1 month 3 weeks

(Nature) – When health workers in Malawi began rolling out the first vaccine proven to protect against malaria, it was a moment 32 years — and more than US$700 million — in the making. The country began giving the vaccine, called RTS,S, to children under age 2 on 23 April. Soon Ghana and Kenya will join in, as part of a large-scale pilot programme backed by the World Health Organization (WHO). The effort could immunize more than one million children by 2023 — a welcome boost in the fight against malaria, which kills an average of 1,200 people worldwide per day. The vast majority are children in Africa.

More Than 20 Million Kids Miss Out on the First Dose of the Measles Vaccine Every Year

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(Quartz) – Amid news of serious measles outbreaks in several countries around the world, the United Nations Children Investment Fund (UNICEF) released a report this week showing that 21.1 million children miss out on the first dose of the measles vaccine every year, creating a “pathway” to the global outbreak. Measles can cause fevers, coughs, and rashes, but also blindness and brain damage in serious cases, and kills about 110,000 children every year.

Faced with an Outcry Over Limits on Opioids, Authors of CDC Guidelines Acknowledge They’ve Been Misapplied

1 month 3 weeks

(STAT News) – The authors of influential federal guidelines for opioid prescriptions for chronic pain said Wednesday that doctors and others in the health care system had wrongly implemented their recommendations and cut off patients who should have received pain medication. “Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations,” the researchers wrote in a paper published in the New England Journal of Medicine.

Japan Apologizes to Victims of Forced Sterilization

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(The Guardian) – Japan’s government has issued an apology and awarded compensation to thousands of people with disabilities who were forcibly sterilised under a now defunct eugenics law. As part of legislation that passed parliament’s upper house on Wednesday, surviving victims will each receive ¥3.2m (£22,000) to compensate for their suffering, as well as an apology from the state “for the great physical and mental suffering caused by the forced sterilisation programme”.

US Measles Cases Hit Highest Mark in 25 Years

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(ABC News) – Measles cases in the U.S. this year have climbed past 680 to their highest level in 25 years, a resurgence largely attributed to misinformation that is turning parents against vaccines. Health officials in hard-hit New York City on Wednesday reported 61 new cases since late last week, in what would make this the nation’s worst year for measles since 1994, with eight months still to go. Other states are reporting more cases, too.

Inside the Quietly Lucrative Business of Donating Human Eggs

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(Wired) – Just before her 21st birthday, she typed “egg donation” into Google, and off she went. Over the next four years, Griffin donated her eggs six times at three different clinics. On four of those occasions, her ovaries became painfully swollen and she experienced weight gain, abdominal pain, severe nausea, and had trouble urinating; one time she was hospitalized. For her efforts, she was paid $61,000.

New Turmoil Over Predicting the Effects of Genes

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(Quanta) – But now, two results published last month have cast doubt on those findings, and have illustrated that problems with interpretations of GWAS results are far more pervasive than anyone realized. The work has implications for how scientists think about the interactions between genetic and environmental effects. It also “raise[s] the ghosts of the possibility that we overestimate … how important genetics is in contributing to differences between people,” said Rasmus Nielsen, a biologist at the University of California, Berkeley.

Novartis Says Baby’s Death May Be Tied to Gene Therapy

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(Bloomberg) – Novartis AG said the death of a six-month-old baby in a study evaluating its experimental gene therapy Zolgensma was considered by the clinical trial investigator to be potentially related to the treatment. The death of the patient with a devastating disease known as spinal muscular atrophy occurred in a late-stage trial in Europe that’s still enrolling patients, the Swiss drugmaker said in an emailed statement. Initial findings show it involved a severe respiratory infection followed by neurological complications. The results of an autopsy are pending, and details have been reported to regulators, the company said.

Distribution of World’s First Malaria Vaccine Begins

1 month 3 weeks

(The Scientist) – A program to vaccinate young children in high-risk areas for malaria begins today (April 23) in Malawi, and will soon roll out in Ghana and Kenya, the World Health Organization announced. WHO plans to pilot the use of the vaccine in conjunction with other preventive measures such as mosquito nets and insecticides.  The immunization requires four doses per child and prevents four in 10 cases of malaria, according to clinical trials.

Former Pharmaceutical Company Execs Hit with Drug Trafficking Charges

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(CNN) – Two former executives of a pharmaceutical distributor company are facing criminal drug trafficking charges on accusations of illegally distributing opioids and conspiring to defraud the US Drug Enforcement Administration, the first time distributors have been criminally charged with these crimes.

When a Treatment Costs $450,000 or More, It Had Better Work

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(The Atlantic) – Bluebird is one of a handful of biotech firms that are trying to soften the sticker shock of new drugs and devices so that more insurance companies will agree to cover them. The premise: The insurers pay only if the drugs work. Known as value-based agreements, these deals are a departure from standard practice in American health care. They respond to a basic moral dilemma in the system: If insurers cover every possible treatment, the cost of coverage will skyrocket. But if insurers won’t pay for experimental drugs for uncommon diseases, those drugs may never be invented at all, or they’ll be available only to the richest patients.

Google Searches for Ways to Put Artificial Intelligence to Use in Health Care

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(NPR) – One of the biggest corporations on the planet is taking a serious interest in the intersection of artificial intelligence and health. Google and its sister companies, parts of the holding company Alphabet, are making a huge investment in the field, with potentially big implications for everyone who interacts with Google — which is more than a billion of us. The push into AI and health is a natural evolution for a company that has developed algorithms that reach deep into our lives through the Web.

China Draws Up Tighter Rules on Human Gene and Embryo Editing

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(Australian Broadcasting Co) – China’s top legislature will consider tougher rules on research involving human genes and embryos, according to Chinese state media. It is the first such move since a Chinese scientist sparked controversy last year by announcing he had made the world’s first “gene-edited” babies.

A Pivotal Test of an Experimental Malaria Vaccine Set to Begin

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(STAT News) – Researchers are preparing to launch a pivotal test of an experimental malaria vaccine this month — one that global health leaders believe could eventually lead to big reductions in the number of cases and deaths worldwide. Despite those high hopes, there are also concerns that the theoretical benefits of the vaccine, made by GSK, might not translate into the real world.

Virus Identified as a Cause of Paralyzing Condition in Minnesota Children

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(Star Tribune) – A virus appears to be the cause behind a rash of polio-like illnesses that struck Minnesota last fall, causing paralyzing symptoms in several children, including one girl who lost all motor function and remains hospitalized. Researchers from Minnesota and the U.S. Centers for Disease Control and Prevention reported Thursday that they found Enterovirus-D68 in the spinal fluid of one of six children who suffered acute flaccid myelitis, or AFM.

The Girl in the Depression Helmet

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(The Atlantic) – Researchers at some academic institutions are taking the technology seriously. Yale has a Repetitive Transcranial Magnetic Stimulation Research Clinic, and the service is offered at Johns Hopkins. Numerous studies have suggested promising clinical uses, including one this week in the journal Neurology. But the mechanisms proposed are vague. TMS may be beneficial in treating addiction, according to a 2017 paper in Nature Neuroscience Reviews, by “influencing neural activity … throughout the brain.” According to the Mayo Clinic: “Though the biology of why TMS works isn’t completely understood, the stimulation appears to impact how the brain is working, which in turn seems to ease depression symptoms and improve mood.”

U.S. Researcher Says He’s Ready to Start Four Pregnancies with ‘Three-Parent’ Embryos

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(STAT News) – Researchers at Columbia University in New York have created embryos containing genetic material from three people and are ready to use them to start pregnancies. But they’re at a legal impasse. At a public forum at Harvard Law School on Wednesday, Dietrich Egli, assistant professor of developmental cell biology at Columbia, said his team has used a controversial technique called mitochondrial replacement therapy to make embryos for four female patients. The women are all carriers of genetic disorders that are passed down through maternal mitochondria, the energy-generating organelles inside cells.

Experimental Gene Therapy Frees “Bubble-Boy” Babies from a Life of Isolation

1 month 4 weeks

(Scientific American) – An experimental gene therapy has restored functioning immune systems to seven young children with a severe disorder that would have sentenced them to a life of isolation to avoid potentially deadly infections. They are now with family at home, and an eighth child is slated to be released from hospital at the end of this week.

Stanford Clears Three Faculty Members of ‘CRISPR Babies’ Involvement

1 month 4 weeks

(STAT News) – Stanford University cleared three faculty members of any misconduct in their interactions with the Chinese scientist who created “CRISPR babies” last year, the school announced on Tuesday evening. A review by a faculty member and an outside investigator concluded that they “were not participants in [He Jiankui’s] research regarding genome editing of human embryos for intended implantation and birth and that they had no research, financial or organizational ties to this research.”

As Calls Mount to Ban Embryo Editing with CRISPR, Families Hit by Inherited Diseases Say, Not So Fast

2 months 11 hours

(STAT News) – Watching all this have been people with a special interest in embryo editing: those who carry genetic mutations that can cause severe disease. They wonder whether experts who denounce embryo editing have any understanding of what millions of people with such inherited diseases — especially ones that have plagued their families for generations — suffer.

Part-Revived Pig Brains Raise Slew of Ethical Quandaries

2 months 12 hours

(Scientific American) – The remarkable study, published in this week’s Nature, offers the promise of an animal or even human whole-brain model in which many cellular functions are intact. At present, cells from animal and human brains can be sustained in culture for weeks, but only so much can be gleaned from isolated cells. Tissue slices can provide snapshots of local structural organization, yet they are woefully inadequate for questions about function and global connectivity, because much of the 3D structure is lost during tissue preparation. The work also raises a host of ethical issues.

First U.S. Patients Treated with CRISPR as Human Gene-Editing Trials Get Underway

2 months 12 hours

(NPR) – The powerful gene-editing technique called CRISPR has been in the news a lot. And not all the news has been good: A Chinese scientist stunned the world last year when he announced he had used CRISPR to create genetically modified babies. But scientists have long hoped CRISPR — a technology that allows scientists to make very precise modifications to DNA — could eventually help cure many diseases. And now scientists are taking tangible first steps to make that dream a reality.

Human Gene Editing Is Controversial. Shoukhrat Mitalipov Isn’t Deterred

2 months 12 hours

(Discover Magazine) – Off screen, the sperm vacuum makes a quick pit stop to grab an additional solution before appearing again, poised and ready. In a moment, the egg will be injected not only with sperm but with a dose of CRISPR-Cas9, a DNA editing system that allows scientists to cut out a gene segment and replace it with another. If all goes well, the CRISPR system will cause this single-celled human embryo to repair a disease-causing mutation in its DNA. This lab, at Oregon Health and Science University (OHSU) in Portland, is the only group in the U.S. to publish this kind of research in human embryos.

Promising Malaria Vaccine to Be Tested in First Large Field Trial

2 months 1 day

(Nature) – A malaria vaccine that can provide up to 100% protection against the disease will be tested in a large clinical trial for the first time, to study its efficacy under real-world conditions. The trial will begin in early 2020 on Bioko, an island off the coast of Equatorial Guinea, and will involve 2,100 people aged 2–50 years. The trial is intended to provide the efficacy and safety data needed for regulatory approval, says malaria researcher Steve Hoffman, who is leading the study and is chief executive of Sanaria, the company in Rockville, Maryland, that developed the vaccine. Equatorial Guinea’s government and private energy companies are sponsoring the trial.

Sex-Selective Abortions May Have Stopped the Birth of 23 Million Girls

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(New Scientist) – A huge analysis of worldwide population data suggests sex-selective abortions have led to at least 23 million fewer girls being born. The majority of these “missing” girls are in China and India. Many societies value sons over daughters. As people around the world increasingly have fewer children, there has been a rise in families choosing to abort female fetuses in an effort to have at least one son. Normally, 103 to 107 boys are born for every 100 girls. But an analysis has found evidence of an unnatural excess of boys in 12 countries since the 1970s, when sex-selective abortions started becoming available.

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