Bioethics.com

Subscribe to Bioethics.com feed
Your global information source on bioethics news and issues
Updated: 2 hours 10 min ago

FDA Pulls Keytruda from Two Clinical Trials after Deaths

September 1, 2017

(UPI) – The FDA has placed a full clinical hold on two clinical trials combining the cancer drug Keytruda with other therapies after an excess of deaths was reported. The agency announced on Thursday that two clinical trials of Keytruda, or pembrolizumab, combined with two other therapies have been halted after the trial sponsor, Merck, stopped enrolling patients into the trials and reported its concerns in June to the FDA.

Skepticism Surfaces over CRISPR Human Embryo Editing Claims

September 1, 2017

(Science) – But such a feat has not been observed in previous CRISPR experiments, and some scientists are now questioning whether the repairs really happened that way. In a paper published online this week on the preprint server bioRxiv, a group of six geneticists, developmental biologists, and stem cell researchers offers alternative explanations for the results. And uncertainty about exactly how the embryos’ DNA changed after editing leaves many questions about the technique’s safety, they argue. (The authors declined to discuss the paper while it’s being reviewed for publication.)

My Son Has Autism. Discrimination Almost Cost Him His Life.

September 1, 2017

(The Washington Post) – Needing a lifesaving transplant is truly awful for any child and family. For children with a disability, the challenges are even more immense. Lief has autism and is a non-speaking person who types to communicate. He struggles with sensory disturbance, profound motor planning difficulties and perseverance behaviors.  Because of our son’s disability, the doctors at our local children’s hospital told us that no facility would perform the transplant, and we should prepare for him to die. A second hospital also refused to consider him.

Hacking Risk Leads to Recall of 500,000 Pacemakers Due to Patient Death Fears

August 31, 2017

(The Guardian) – Almost half a million pacemakers have been recalled by the US Food and Drug Administration (FDA) due to fears that their lax cybersecurity could be hacked to run the batteries down or even alter the patient’s heartbeat. The recall won’t see the pacemakers removed, which would be an invasive and dangerous medical procedure for the 465,000 people who have them implanted: instead, the manufacturer has issued a firmware update which will be applied by medical staff to patch the security holes.

Study Shows Sequencing All 24 Chromosomes Reveals Rare Disorders

August 31, 2017

(UPI) – Researchers at the National Institutes of Health recommend extending noninvasive prenatal testing to all 24 human chromosomes to detect genetic disorders. The standard method of genomic testing performed during pregnancy targets extra copies of chromosomes 21, 18 and 13 but rarely includes all 24 human chromosomes.

Why China’s Traditional Medicine Boom Is Dangerous

August 31, 2017

(The Economist) – But evidence that TCM works is scanty. Clinical trials in scientific journals have reported some examples of effective TCM treatments, for example against migraines and obesity. They have found some cases where TCM works well in combination with Western medicine, for example, in treating schizophrenia. However, the overall record is poor. America’s National Institutes of Health looked at 70 systematic reviews of TCM treatments. In 41 of them, the trials were too small or badly designed to be of use. In 29, the studies showed possible benefits but problems with sample sizes and other flaws meant the results were inconclusive.

Cholera Hits Camp for Displaced in Northeast Nigeria

August 31, 2017

(Reuters) – Cholera has broken out in northeast Nigeria at a camp for people displaced by the eight year conflict with Boko Haram, aid group Médecins Sans Frontières said on Thursday, bringing disease to communities already underfed and living in squalor. The outbreak in the city of Maiduguri, the epicenter of the fight against the Islamist insurgents, confirms aid groups’ fears that Nigeria’s rainy season could spread disease in camps for the internally displaced that are often already unsanitary.

In Mega-Shelter for Harvey Evacuees, Telemedicine Plans to Help Doctors Keep Up

August 31, 2017

(STAT News) – Getting thousands of Houston-area families to shelters has been a massive humanitarian effort. But the aid doesn’t end there: Many of the displaced have chronic medical conditions like asthma or injuries from recent days that need medical attention. Providers of telemedicine are hoping technology can help step into the breach. At Kay Bailey Hutchison Convention Center in Dallas, which has begun to take residents displaced by flooding in Houston, emergency-room doctors at Children’s Health, a pediatric hospital based in Dallas, are seeing young patients remotely.

Groups Seek Ban on High-Dose Opioids Citing Overdose Danger

August 31, 2017

(ABC News) – Safety advocates and state health officials are formally calling on the Food and Drug Administration to ban high-dose opioid painkillers to prevent accidental overdose deaths among patients and people who abuse drugs. A petition filed Thursday asks the FDA to ban opioid pills that, when taken as directed, would add up to a daily dose of more than 90 milligrams of morphine. The Centers for Disease Control and Prevention has said that level is dangerous for most patients and doesn’t improve pain control or the ability to function.

FDA Approves First Gene Therapy for Leukemia

August 31, 2017

(NPR) – The Food and Drug Administration on Wednesday announced what the agency calls a “historic action” — the first approval of a cell-based gene therapy in the United States. The FDA approved Kymriah, which scientists refer to as a “living drug” because it involves using genetically modified immune cells from patients to attack their cancer. The drug was approved to treat children and young adults up to age 25 suffering from a form of acute lymphoblastic leukemia who do not respond to standard treatment or have suffered relapses.

Artificial Intelligence Researchers Must Learn Ethics

August 31, 2017

(The Conversation) – Scientists who build artificial intelligence and autonomous systems need a strong ethical understanding of the impact their work could have. More than 100 technology pioneers recently published an open letter to the United Nations on the topic of lethal autonomous weapons, or “killer robots”.  These people, including the entrepreneur Elon Musk and the founders of several robotics companies, are part of an effort that began in 2015. The original letter called for an end to an arms race that it claimed could be the “third revolution in warfare, after gunpowder and nuclear arms”.

Egypt Promotes Birth Control to Fight Rapid Population Growth

August 30, 2017

(Reuters) – Egypt is pushing to educate people in rural areas on birth control and family planning in a bid to slow a population growth rate that President Abdel Fattah al-Sisi said poses a threat to national development. The country is already the most populous in the Arab world with 93 million citizens and is set to grow to 128 million by 2030 if fertility rates of 4.0 births per thousand women continue, according to government figures.

Trial Raises Parkinson’s Therapy Hope

August 30, 2017

(BBC) – Scientists have restored nerve cells destroyed by a condition similar to Parkinson’s disease, in monkeys. The Japanese team hope their work could lead to stem cell trials in human patients before the end of 2018. Parkinson’s disease causes the progressive loss of nerve cells that release dopamine, a chemical that helps control body movement. The researchers triggered a similar loss of cells in macaque monkeys, then used human stem cells to replace them.

Hurricane Katrina Left Survivors Vulnerable to Sexual Assault. Here’s How to Protect Harvey Evacuees.

August 30, 2017

(Vox) – The chaos during and after Hurricane Katrina left many people vulnerable to sexual assault, as William E. Thornton and Lydia Voigt note in a 2007 paper in which Neville’s story appears. As Hurricane Harvey continues to cause flooding along the Texas and Louisiana coast, some of the same risks apply as people are forced from their homes into shelters or into other temporary living arrangements that may not be safe. The good news: Aid workers have the lessons of Katrina to fall back on as they try to help the thousands of people displaced by this storm.

Pioneering Cancer Drug, Just Approved, to Cost $475,000–and Analysts Say It’s a Bargain

August 30, 2017

(STAT News) – The Food and Drug Administration on Wednesday approved a futuristic new approach to treating cancer, clearing a Novartis therapy that has produced unprecedented results in patients with a rare and deadly cancer. The price tag: $475,000 for a course of treatment. That sounds staggering to many patients — but it’s far less than analysts expected. The therapy, called a CAR-T, is made by harvesting patients’ white blood cells and rewiring them to home in on tumors. Novartis’s product is the first CAR-T therapy to come before the FDA, leading a pack of novel treatments that promise to change the standard of care for certain aggressive blood cancers.

Offshore Human Testing of Herpes Vaccine Stokes Debate over U. S. Safety Rules

August 30, 2017

(Kaiser Health News) – Defying U.S. safety protections for human trials, an American university and a group of wealthy libertarians, including a prominent Donald Trump supporter, are backing the offshore testing of an experimental herpes vaccine. The American businessmen, including Trump adviser Peter Thiel, invested $7 million in the ongoing vaccine research, according to the U.S. company behind it. Southern Illinois University also trumpeted the research and the study’s lead researcher, even though he did not rely on traditional U.S. safety oversight in the first trial, held on the Caribbean island of St. Kitts.

Stay Safe and Get a Tetanus Shot, Texas Health Officials Urge

August 30, 2017

(NPR) – As health departments in Texas try to assist people with immediate medical needs following Hurricane Harvey, they’re also looking to ensure that those affected can get the prescription drugs they need and stay as safe as possible. “Our best advice is always to avoid floodwater as much as you can,” says Chris Van Deusen, a spokesman for the Texas Department of State Health Services. “Of course, people have had to be in the water — they haven’t had a choice.”

With a Simple DNA Test, Family Histories Are Rewritten

August 30, 2017

(New York Times) – The question of ethnicity is enmeshed with another difficult challenge for DNA testers: geography. Genetics researchers generally know which DNA sequences originated on which continents. But pinpointing a particular country of origin, as many testing services claim to do, is far trickier. Scientists simply do not have good data on the genetic characteristics of particular countries in, say, East Africa or East Asia. Even in more developed regions, distinguishing between Polish and, for instance, Russian heritage is inexact at best.

The Genetics of Eating Disorders

August 30, 2017

(Scientific American) – While more and more people have come to understand that eating disorders are diseases of the brain, there’s still a widespread belief that people with these devastating conditions are vain, attention-seeking, or lacking in will power. But a paper just published in Plos One makes it clear that this isn’t true. The study evaluated the genomes of 95 individuals with diagnosed eating disorders and identified 430 genes, clustered into two large groups, that are more likely to be damaged than in people without those disorders.

FDA Cracks Down on Stem-Cell Clinics Selling Unapproved Treatments

August 30, 2017

(NPR) – The Food and Drug Administration is cracking down on “unscrupulous” clinics selling unproven and potentially dangerous treatments involving stem cells. Hundreds of clinics around the country have started selling stem cell therapies that supposedly use stem cells but have not been approved as safe and effective by the FDA, according to the agency.

Pages