News from Bioethics.com

Cannabis Companies Push F.D.A. to Ease Rules on CBD Products

2 months 1 week

(New York Times) – The F.D.A. has been skeptical of the rapidly growing cannabis industry, but it is under increasing pressure from Congress to ease the path to market for cannabis-derived products. These products are different from medical marijuana, which a growing number of states allow for treating severe pain, nausea and other ailments. Conservative estimates predict that sales of CBD in the United States could be $16 billion by 2025.

Analysis: Why Alexa’s Bedside Manner Is Bad for Health Care

2 months 1 week

(Kaiser Health News) – Virtual communications have streamlined life and transformed many of our relationships for the better. There is little need anymore to sit across the desk from a tax accountant or travel agent or to stand in a queue for a bank teller. And there is certainly room for disruptive digital innovation in our confusing and overpriced health care system. But it remains an open question whether virtual medicine will prove a valuable, convenient adjunct to health care. Or, instead, will it be a way for the U.S. profit-driven health care system to make big bucks by outsourcing core duties — while providing a paler version of actual medical treatment?

Could Antibiotics Be a Silver Bullet for Kids in Africa?

2 months 2 weeks

(NPR) – The story starts in 2009, when a group of ophthalmologists from the University of California, San Francisco published some surprising results from a study they had conducted in Ethiopia on trachoma, an eye infection that is the world’s leading cause of preventable blindness. The eye doctors knew that the antibiotic azithromycin was effective in fighting the disease and had administered it to tens of thousands of children there, ages 1 to 9. Meanwhile, they wanted to keep watch on whether the drug seemed to have any other beneficial effects on the children’s health. What they found was remarkable: Mass azithromycin treatment, administered two times a year, seemed to have an almost miraculous ability to reduce childhood deaths. 

Redefining Normal: Study Shows Mutations Even in Healthy Tissues Throughout the Body

2 months 2 weeks

(STAT News) – A large-scale analysis published Thursday in Science examined more than 6,700 samples of normal human tissue from 29 major tissue groups — from brain and bladder to breast and prostate tissue. The researchers used RNA sequencing data to look in these tissues for large mutational clones — groups of cells that have the same mutations. They found many more clones than they had expected, including some that contained mutations that drive cancer. “This study opens up the big question of what is normal?” said Cristian Tomasetti, an associate professor of oncology at Johns Hopkins University who was not involved with the study. “This is now a picture of our normal tissues being quite messy and full of these mutational clones. We are really at the beginning of knowing how to evaluate them.”

Welcome to the Age of One-Shot Miracle Cures That Can Cost Millions

2 months 2 weeks

(Bloomberg) – This is the tantalizing promise of gene therapies, the potential cures for dozens of once-incurable illnesses. The U.S. Food and Drug Administration issued its first approval of a systemic gene therapy, a Novartis AG treatment for spinal muscular atrophy, on May 24 and says it expects to approve 10 to 20 therapies a year starting in 2025. There are more than 800 trials under way, targeting diseases including rare metabolic disorders, sickle cell anemia, hemophilia, and Parkinson’s. As the list grows, such treatments have the potential to fundamentally remake the health-care system at every level. There are two big caveats. First, most studies haven’t run longer than a few years, so it’s impossible to know yet whether the therapies will remain effective for life, help everyone the same, or yield side effects decades in the future.

Dallas Woman’s Push to Make Fertility Fraud a Crime Results in New Law on the Books in Texas

2 months 2 weeks

(Dallas Morning News) – Gov. Greg Abbott signed a bill late Tuesday that makes fertility fraud a crime in Texas. “It’s very validating,” Eve Wiley, the Dallas woman who pushed for the law, said early Wednesday. Wiley said her world and sense of identity were shaken badly last year when she discovered that her mother’s fertility doctor is her biological father.

Doctor Accused of Murder in 25 Patient Overdose Deaths

2 months 2 weeks

(ABC News) – A critical care doctor was arrested and charged with murder Wednesday in the deaths of 25 hospital patients authorities say were deliberately given overdoses of painkillers. The charges against Dr. William Husel, 43, form one of the biggest murder cases ever brought against a health care professional in the U.S. He pleaded not guilty to 25 counts of murder, and a judge set bail at $1 million.

U.S. Health Agency Cancels Research Contract Involving Use of Fetal Tissue

2 months 2 weeks

(Reuters) – The Department of Health and Human Services (HHS) said on Wednesday it would cancel its research contract involving human fetal tissue from elective abortions with the University of California. The decision follows an audit of all HHS research involving human fetal tissue from elective abortions in light of “the serious regulatory, moral and ethical considerations involved,” the U.S. agency said.

Expanded Potential Stem Cells of Both Pig and Human Cells Created

2 months 2 weeks

(GEN) – Scientists say they have developed a novel technique to create expanded potential stem cells (EPSCs) of both pig and human cells. These stem cells have the features of the first cells in the developing embryo and can develop into any type of cell, according to the research team from the LKS Faculty of Medicine of The University of Hong Kong (HKUMed), the Wellcome Sanger Institute, and the Friedrich-Loeffler-Institut in Germany. Their work (“Establishment of porcine and human expanded potential stem cells”), published in Nature Cell Biology, also offers great potential for studying human development and regenerative medicine, they added.

U.S. Infant and Maternal Mortality Rates: Shamefully (and Unnecessarily) Bad and Getting Worse

2 months 2 weeks

(Managed Care Magazine) – While overall U.S. infant mortality is lower than it was in the ’60s, how can the country that spends more per person on health care than any other in the entire world by far have made so little progress while rates in Singapore and elsewhere have improved? Indeed, the U.S. rate is now higher than infant mortality rates in Antigua or Cuba. Furthermore, the overall U.S. rate masks significant disparities. The infant mortality rate of non-Hispanic black infants is 11.2 per 1,000 live births, which is comparable to the rate in Libya or Tunisia. 

Ebola Cases Pass 2,000 as Crisis Escalates

2 months 2 weeks

(Nature) – The number of Ebola cases in the Democratic Republic of the Congo (DRC) has doubled in just over two months and has now passed 2,000, according to the World Health Organization (WHO). An estimated 2,008 people have been infected with Ebola in the North Kivu and Ituri provinces since the start of the outbreak in late July 2018, and 1,346 of those individuals have died. The numbers represent a rapid escalation of the crisis since the outbreak passed the 1,000-case mark on 24 March (see ‘Escalating crisis’).

Reproducibility Trial Publishes Two Conclusions for One Paper

2 months 2 weeks

(Nature) – How deeply an anaesthetist should sedate an elderly person when they have surgery is a controversial issue, because some studies link stronger doses of anaesthetic with earlier deaths. So it should reassure clinicians to see a study in the British Journal of Anaesthesia that investigates and rules out such a link — the published paper’s discussion section says so explicitly: “These results are reassuring.” Or are they? Another paper in the journal analyses the same results and reaches a different conclusion about death rates. It says the trial didn’t include enough patients to reach that conclusion — or any conclusion — on mortality.

Congress Revives Ban on Altering the DNA of Human Embryos Used for Pregnancies

2 months 2 weeks

(STAT News) – A House committee on Tuesday restored to pending legislation a ban on altering the genomes of human embryos intended for pregnancies, despite calls from some scientists to lift the ban and allow the Food and Drug Administration to review applications for new technologies. Lifting the prohibition could have opened the door to clinical trials of babies being made with genetic material from three people or with genomes that had been changed in ways that would be passed on to future generations.

California Man Becomes First ‘Death with Dignity’ Patient to Undergo Cryonic Preservation

2 months 2 weeks

(Gizmodo) – A terminally ill patient who opted for assisted death has undergone cryonic preservation at the Alcor Life Extension Foundation. This preservation—the first of its kind—signifies an important milestone for cryonics advocates, who argue that the right to death, paradoxically, is a potential pathway to an eternal life.

When ‘Right to Try’ Isn’t Enough: Congress Wants a Single ALS Patient to Get a Therapy Never Tested in Humans

2 months 2 weeks

(STAT News) – The Hermstads’ progress reopens an ardent debate in Washington over the FDA’s role in determining when sick or dying patients can access experimental therapies — and what role career politicians should play in the nation’s decisions about how and when to let patients access untested treatments. It also underscores a fundamental question about the role of lawmakers: Is it fair for a member of Congress to intervene on behalf of a single constituent?

The Surgeon Had a Dilemma Only a Nazi Medical Text Could Resolve. Was It Ethical to Use It?

2 months 2 weeks

(STAT News) – The moral dilemma for surgeons is that, even now, the Pernkopf illustrations are unsurpassed in their accuracy and detail, especially their depiction of peripheral nerves. “I hate to say it, but the illustrations are beyond spectacular,” said bioethicist and Rabbi Joseph Polak of Boston University, whom the Washington University team consulted. “They are really world-class.” Other anatomy atlases pale by comparison, Yee said, and although a few journal papers may have an equally good, single illustration, finding the right paper takes time that Mackinnon did not have as she stood over her patient.

A Mutation That Resists HIV Has Other Harmful Consequences

2 months 2 weeks

(The Atlantic) – The girls’ CCR5 genes were altered, according to data He presented, but they do not exactly match the 32-letter deletion; it’s unclear whether either of them is actually resistant to HIV. Even if they were unable to get HIV, a body of research already suggested that CCR5-?32 made people more vulnerable to the flu and West Nile virus. A “good” mutation in the context of HIV can be “bad” in another context. No one knew, exactly, the net effect of a CCR5-?32 mutation. However, the new study, by Rasmus Nielsen and Xinzhu “April” Wei of UC Berkeley, shows that people with two copies of the mutation are 21 percent more likely to die at the age of 76, with a mortality rate of 16.5 percent, compared with 13.6 percent for those who have only one or zero copies.

Caster Semenya Free to Run 800m Without Medication for Now as Swiss Court Floors IAAF

2 months 2 weeks

(The Guardian) – Caster Semenya is once again free to run the 800m without having to take medication – at least for the time being – after the Swiss supreme federal court ordered the IAAF to suspend its testosterone regulations for athletes with differences in sexual development with immediate effect. The surprise news – which completely blindsided athletics’ governing body – means that the Olympic champion and other DSD athletes can compete in distances ranging from 400m to a mile without medication until at least 25 June.

Race Disparity in U.S. Prostate Cancer Deaths Disappears with Equal Care

2 months 3 weeks

(Reuters) – Black men are more likely to die of prostate cancer than white men in the U.S., but a new study suggests this racial disparity may be largely due to differences in the medical care men receive. Black men are more likely to be diagnosed with prostate cancer, more apt to have advanced disease at the time of diagnosis, and more than twice as likely to die of the disease than white men in the U.S., researchers note in JAMA Oncology. 

U.S. Measles Cases Hit 971, Highest Single-Year Total Since 1994

2 months 3 weeks

(UPI) – Measles cases in the United States have hit a high of 971, shattering the 943 cases in 1994 to be the highest number of cases in 25 years — and it comes barely halfway into the year. The Centers for Disease Control and Prevention reported the number on Thursday afternoon, the agency’s second measles count released this week. Monday’s report, of 940 cases reported through May 24, already was the second highest since 1994.

Million-Person U.S. Study of Genes and Health Stumbles Over Including Native American Groups

2 months 3 weeks

(Science) – Earlier this month, leaders of the National Institutes of Health (NIH) in Bethesda, Maryland, celebrated the 1-year anniversary of the effort, which aims to gather DNA and health records for 1 million volunteers by the end of 2024. They pointed with pride to the study’s diversity: More than 50% of the 143,000 volunteers fully enrolled so far belong to minority groups. They did not mention that Native Americans, who make up 1.7% of the U.S. population, are not formally on board.

Half of H.I.V Patients Are Women. Most Research Subjects Are Men.

2 months 3 weeks

(New York Times) – Inspired by reports of a second patient apparently freed of infection with H.I.V., the virus that causes AIDS, scientists are pursuing dozens of ways to cure the disease. But now, researchers must reckon with a longstanding obstacle: the lack of women in clinical trials of potential H.I.V. treatments, cures and vaccines. Women make up just over half of the 35 million people living with H.I.V. worldwide, and the virus is the leading cause of death among women of reproductive age. In Africa, parts of South America and even in the southern United States, new infections in young women are helping to sustain the epidemic.

A Final Comfort: ‘Palliative Transport’ Brings Dying Children Home

2 months 3 weeks

(Kaiser Health News) – Palliative transport lets families move critically ill children from the hospital intensive care unit to their home or hospice, with the expectation they will die within minutes to days after removing life support. It means “having parents go through the hardest thing they’ll ever know — in the way they want to do it,” Nelson said. Boston Children’s has sent 19 children to home or hospice through palliative transport since 2007, she said.

A Final Comfort: ‘Palliative Transport’ Brings Dying Children Home

2 months 3 weeks

(Kaiser Health News) – Palliative transport lets families move critically ill children from the hospital intensive care unit to their home or hospice, with the expectation they will die within minutes to days after removing life support. It means “having parents go through the hardest thing they’ll ever know — in the way they want to do it,” Nelson said. Boston Children’s has sent 19 children to home or hospice through palliative transport since 2007, she said.

‘She’s Wiggling Her Toes’: New Fetal Surgery for Spina Bifida May Be Safer for Both Baby and Mom

2 months 3 weeks

(STAT News) – About a decade ago, Chmait heard about a pioneering Brazilian scientist and surgeon, Dr. Denise Lapa, who had spent years developing a way to repair spina bifida in the womb without making large incisions in the uterus or the abdomen. (Brazil, where abortion is illegal and malnutrition is more common, has a high rate of spina bifida.) Lapa has done nearly 100 of the surgeries and, according to Chmait, helped with the first one performed in the United States, at New York-Presbyterian Hospital last year; it was not publicized. For years, Chmait has traveled to Brazil to observe and learn the technique, in which the uterus and fetus remain inside the body during the procedure.

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