News from Bioethics.com

Breastfeeding Women Need to Know More About the Risks of Taking Medication, Experts Say

2 months 1 week

(STAT News) – A growing number of babies born in the U.S. are breastfed, and health officials are pushing to make it easier for even more new mothers to nurse their babies. But experts say there still isn’t enough research about one of the most common experiences among lactating women: taking medication. Scientific studies frequently exclude pregnant and lactating women, which means there’s little information about whether drugs are safe to use while pregnant or breastfeeding, how well they work, or the best doses to take.

Dozens of Clinics Market Risky Cell Therapies to Treat Eye Disorders

2 months 1 week

(Reuters) – Scores of clinics across the United States directly advertise expensive – but unproven – cell therapy procedures to patients with serious eye diseases, often with devastating results, a new study warns. Although there are no approved stem cell therapies to treat eye conditions in the U.S., when the authors of the study conducted a systematic internet search they found 40 companies with 76 clinics that advertised the procedures.

Bioethicists Concerned Over Japan’s Chimera Embryo Regulations

2 months 1 week

(The Scientist) – Japanese regulators have effectively given the green light to research involving human-animal chimera embryos, which are created by implanting human pluripotent stem cells into animals in early development. The revised guidelines, issued in early March, lift a previous requirement to terminate such embryos after 14 days. The revisions now pave the way for Japanese scientists to study how to grow human organs in animals as an alternative to organ transplantation, and to produce better models to study human development and disease.

FDA Developing New Rules for Artificial Intelligence in Machines

2 months 1 week

(STAT News) – The Food and Drug Administration announced Tuesday that it is developing a framework for regulating artificial intelligence products used in medicine that continually adapt based on new data. The agency’s outgoing commissioner, Scott Gottlieb, released a white paper that sets forth the broad outlines of the FDA’s proposed approach to establishing greater oversight over this rapidly evolving segment of AI products.

Do Animals Hold the Key to the Global Organ Shortage?

2 months 2 weeks

(The Guardian) – Researchers in South Korea are expected to transplant pig corneasinto humans within a year. A handful of groups across the US are also working toward pig organ clinical trials in the next few years, including a group at Massachusetts General Hospital in Boston that is starting a six-person clinical trial using “blankets” of pig skin to temporarily protect the skin of burn victims. At the University of Alabama at Birmingham’s (UAB) medical school, researchers are planning to transplant pig kidneys into adults and hearts into struggling newborns.

Cholera Vaccinations Launched in Post-Cyclone Mozambique

2 months 2 weeks

(Reuters) – Health officials launched a vaccination campaign in Mozambique’s cyclone-hit port city of Beira on Wednesday in an effort to contain an outbreak of cholera that has already infected more than 1,400 people, the World Health Organization (WHO) said. Some 900,000 doses of oral cholera vaccine arrived on Tuesday in Mozambique, where Cyclone Idai last month flattened homes and unleashed widespread flooding.

Cameras Secretly Recorded Women in California Hospital Delivery Rooms

2 months 2 weeks

(CNN) – A women’s hospital in California used hidden cameras to secretly record approximately 1,800 patients without their consent, according to a lawsuit. The recordings filmed activity in three labor and delivery operating rooms at the Women’s Center at Sharp Grossmont Hospital in La Mesa, California, over a period of more than 11 months beginning in summer 2012.

Elite Hospitals Plunge Into Unproven Stem Cell Treatments

2 months 2 weeks

(Kaiser Health News) – It was sponsored by Swedish Medical Center, the largest nonprofit health provider in the Seattle area. Swedish is one of a growing number of respected hospitals and health systems — including the Mayo Clinic, the Cleveland Clinic and the University of Miami — that have entered the lucrative business of stem cells and related therapies, including platelet injections. Typical treatments involve injecting patients’ joints with their own fat or bone marrow cells, or with extracts of platelets, the cell fragments known for their role in clotting blood. Many patients seek out regenerative medicine to stave off surgery, even though the evidence supporting these experimental therapies is thin at best, Knoepfler said.

Second Example Reported of a Stem-Cell Transplant in the Clinic Leading to HIV Remission

2 months 2 weeks

(Nature) – HIV infects immune cells, and the current standard treatment is long-term use of antiretroviral drugs. This keeps virus levels low in the bloodstream but doesn’t eradicate HIV from cells in the body. In 2009, it was reported1 that a person with HIV (commonly referred to as the Berlin patient) who was treated for cancer using a stem-cell transplant subsequently went into viral remission — the virus became undetectable in their body, even in the absence of antiretroviral therapy. No other cases of long-term HIV remission occurring in this way had been recorded since then. But now, writing in Nature, Gupta et al. report a person who has achieved HIV remission for at least 18 months.

Cholera Kills Two, Infects 1,400 in Cyclone-Hit Mozambique

2 months 2 weeks

(Medical Xpress) – A cyclone-induced cholera outbreak in central Mozambique has killed two people and infected more than 1,400, the government announced Tuesday on the eve of the launch of a mass vaccination drive. Health authorities said 376 new cholera cases had been reported Tuesday, taking the total number of people infected to 1,428 since the first cases were reported last week.

Suicide Risk Grew After Missouri Medicaid Kids Shifted to Managed Care, Hospitals Say

2 months 2 weeks

(Kaiser Health News) – After more than 2,000 Missouri children diagnosed with mental illness were shifted from traditional Medicaid into three for-profit managed-care companies, the state’s hospitals noticed an alarming trend: a doubling in the percentage who had thoughts of suicide or attempted suicide. Additionally, the average length of stay for these children in psychiatric hospitals dropped from 10 days to seven following the Medicaid change in May 2017, according to a study released this month by the Missouri Hospital Association.

Congo Ebola Outbreak Spreading Faster Than Ever: WHO

2 months 2 weeks

(Reuters) – Democratic Republic of Congo’s Ebola outbreak is spreading at its fastest rate yet, eight months after it was first detected, the World Health Organization (WHO) said on Monday. Each of the past two weeks has registered a record number of new cases, marking a sharp setback for efforts to respond to the second biggest outbreak ever, as militia violence and community resistance have impeded access to affected areas.

IVF Tied to Slight Increased Risk of Rare Childhood Cancers

2 months 2 weeks

(Reuters) – Certain rare childhood cancers may be more common in children conceived via in vitro fertilization (IVF), a U.S. study suggests, but parents needn’t lose sleep over this finding, according to the researchers. “For the few cancers that seemed associated with IVF the absolute risk was still extremely rare,” said lead study author Logan Spector of the University of Minnesota in Minneapolis.

First Gene Therapy to Treat Rare Blood Disease Nears European Approval

2 months 2 weeks

(STAT News) – T he first gene therapy to treat a rare blood disorder is one step closer to approval Friday following a recommendation by European officials. Lentiglobin, the gene therapy for beta-thalassemia developed by Cambridge, Mass.-based Bluebird Bio, was recommended for approval by the Committee for Medicinal Products for Human Use (CHMP), the drug-reviewing arm of the European Medicines Agency. A final approval decision is expected within the next three months.

Portugal Baby Born to Woman Brain Dead for Three Months

2 months 2 weeks

(BBC) – A funeral is being held for a 26-year-old woman who gave birth to a baby boy on Thursday despite being brain dead since December. International sportswoman Catarina Sequeira was declared brain dead after an acute asthma attack at her home. The baby, named Salvador, was born when she was almost 32 weeks pregnant and is being cared for in a neonatal hospital. This is the second such case in Portugal of a baby born to a mother who was brain dead.

A DNA Company Wants You to Help Catch Criminals

2 months 2 weeks

(The Atlantic) – Give us your DNA. Help catch a criminal. That’s the message of a recent ad from the genetic testing company Family Tree DNA. The video stars Ed Smart, whose daughter Elizabeth Smart was abducted at age 14, exhorting viewers to upload their DNA profiles to the company’s website. Not so long ago, DNA-testing companies were known only for their promise to unlock medical secrets or trace family histories. What’s changed is the arrest of the alleged Golden State Killer. Since police tracked down a suspect in the notorious case by uploading crime scene DNA and finding distant relatives on a genealogy website, the same technique has led to dozens more arrests for rapes and murders. Forensic genealogy has become, if not exactly routine, very much normalized.

World’s First Living Donor HIV-to-HIV Kidney Transplant Delivers Hope

2 months 2 weeks

(UPI) – The world’s first kidney transplantation from a person living with HIV to a recipient also living with HIV took place on Monday. Surgeons at Johns Hopkins Medicine performed the procedure on Nina Martinez, a 35-year-old woman living with HIV, who donated her kidney to an unnamed recipient. “A disease that was a death sentence in the 1980s has become one so well-controlled that those living with HIV can now save lives with kidney donation — that’s incredible,” Dorry Segev, professor of surgery at the Johns Hopkins University School of Medicine, said in a news release.

False Hope for Autism in the Stem Cell Underground

2 months 2 weeks

(Spectrum) – Many parents of autistic children are, like the Perskins, turning to social media to exchange information on stem cell clinics, which have proliferated in the United States and abroad over the past few years. These forums play down the fact that only a small fraction of stem cell treatments — specifically, those for generating blood cells — have been proven safe and effective in the eyes of the U.S. Food and Drug Administration (FDA).

How Much Prenatal Genetic Information Do You Actually Want?

2 months 2 weeks

(Wired) – But what is available is something called noninvasive prenatal genetic screening (NIPT). Based on a blood sample from mom, they have been used for several years to tell expectant parents if their baby might have, say, a chromosomal abnormality. Then the parents might make the choice to terminate the pregnancy—or to prepare for a child with disabilities. Makers of those tests, though, are already pushing the technology beyond its recommended uses to flag a rapidly expanding list of the unborn’s potential genetic flaws. But these bigger and bigger menus of genetic testing also come with less and less information about how predictive the data they reveal actually is. And as these types of tests become routine, women like Hamann have to figure out what they want to know, and what they’ll do with the information they receive.

Drug Rationing Common for Shortages, Patient Disclosure Rare

2 months 2 weeks

(Medscape) – Drug shortages of all types have slowly become the new normal in US healthcare, affecting supplies of everything from sterile saline solution to essential oncologic agents. But while these shortages continue to be highlighted in the media, a new study now shows that the method of addressing the issue is by rationing drugs — and often without the knowledge of the patient.

Their Baby Died During His Nap. Then Medical Bureaucrats Deepened the Parents’ Anguish

2 months 3 weeks

(STAT News) – When an infant unexpectedly stops breathing during sleep, the usual bureaucracy of death is multiplied, the paperwork thickened with accusation. Investigations are triggered with the local police, the state police, the agency that checks for child abuse. In some jurisdictions, officials appear soon afterward, asking parents to re-enact what happened, a doll standing in for their baby. The medical examiner or coroner takes the body, to determine a cause of death, looking for hints of “foul play.” These protocols are designed to protect. Often they do. But how an officer or medical examiner carries them out can sharpen the suspicion inherent in any investigation, heightening parents’ self-blame even when there’s no evidence of wrongdoing.

America Is Too Glib About Breast Implants

2 months 3 weeks

(The Atlantic) – Boob jobs have been ubiquitous in American popular culture since the 1980s, when laws changed to allow plastic surgeons to advertise and credit cards became widely available. But safety concerns have dogged the procedure since the first silicone breast enhancements were successfully implanted by Texas surgeons in 1962. In that time, the Food and Drug Administration has banned the use of silicone implants and then reinstated them on the condition that the industry closely monitor their impact on patients. Now both silicone implants and the more popular, saline-filled alternatives have found themselves under the agency’s lens again, this time over their potential links to a rare cancer and claims from patients that they cause pain, chronic fatigue, and autoimmune problems.

More Than 1,000 People Are Infected with Ebola in DR Congo and the Outbreak Is Still Spreading

2 months 3 weeks

(Quartz) – The Democratic Republic of Congo is in the midst of the worst Ebola outbreak the country has ever experienced, it’s spread heightened by suspicion and violence. The relationship between aid workers, the state and affected communities has become “toxic” with distrust in the already restive eastern part of the country. Since the outbreak was first identified in August 2018, more than 1,000 people have been infected with the haemorrhagic virus, with 639 deaths as of Mar. 26, according to the national health ministry.

Purdue Pharma, Maker of OxyContin, Settles Opioids Lawsuit in Oklahoma

2 months 3 weeks

(STAT News) – The maker of OxyContin and the company’s controlling family agreed to pay $270 million in a deal announced Tuesday with the state of Oklahoma to settle allegations they helped set off the nation’s deadly opioid crisis with their aggressive marketing of the powerful painkiller. It is the first settlement to come out of the recent coast-to-coast wave of lawsuits against Stamford, Connecticut-based Purdue Pharma that threaten to push the company into bankruptcy and have stained the name of the Sackler family, whose members are among the world’s foremost philanthropists.

New York County, Declaring Emergency Over Measles, Seeks to Ban Unvaccinated from Public Places

2 months 3 weeks

(STAT News) – C aught in the grips of a persistent and long-running measles outbreak, a New York county on Tuesday took the extraordinary step of announcing it would ban children who have not been vaccinated against the disease from enclosed public places as part of a 30-day state of emergency. Schools, houses of worship, shopping malls in Rockland County — anywhere that people who are not related to one another congregate — will be off limits for unvaccinated children, officials said.

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