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FDA Advisers Back Gene Therapy for Rare form of Blindness

Fri, 10/13/2017 - 13:22

(Nature) – Advisers to the US Food and Drug Administration (FDA) have paved the way for the agency’s first approval of a gene therapy to treat a disease caused by a genetic mutation. On 12 October, a panel of external experts unanimously voted that the benefits of the therapy, which treats a form of hereditary blindness, outweigh its risks. The FDA is not required to follow the guidance of its advisers, but it often does. A final decision on the treatment, called voretigene neparvovec (Luxturna), is expected by 12 January.

The Ghosts of HeLa: How Cell Line Misidentification Contaminates the Scientific Literature

Thu, 10/12/2017 - 14:11

(PhysOrg) – HeLa cells are used in biomedical research around the world. HeLa was named after Henrietta Lacks, the woman whose cervical cancer cells were biopsied and used for medical research. Those cells were found to reproduce indefinitely in the lab, making them the world’s first immortalised cell line and one of the most important and commonly used cell lines in medical research to this day. HeLa cells were thrust into the public eye in recent years thanks to the book and the made-for-TV film of the same name The Immortal Life of Henrietta Lacks. Unfortunately, HeLa cells have been contaminating other cell cultures for decades.

How Doctors’ Bias Leads to Unfair and Unsound Medical Triage

Thu, 10/12/2017 - 14:04

(Aeon) – When someone is sick or needs the help of a physician, who should decide what is appropriate – what blood tests and imaging studies to order, what medicines to prescribe, what surgeries to perform? Should it be the doctor, the patient or some combination of the two? Most people nowadays (even most physicians) support what is called ‘shared decision-making’, in which the doctor and patient (and often her family or friends) discuss the situation and come up with a joint plan.

To Accelerate New Cancer Treatments, NIH Will Team Up with Pharma on Immunotherapy Research

Thu, 10/12/2017 - 13:54

(STAT News) – The National Institutes of Health on Thursday announced a $215 million public-private partnership with 11 pharmaceutical companies in what the agency bills as a significant next step in its cancer moonshot. The Partnership for Accelerating Cancer Therapies, or PACT, is a five-year agreement to push ahead with research that seeks to “identify, develop and validate robust biomarkers — standardized biological markers of disease and treatment response — to advance new immunotherapy treatments that harness the immune system to attack cancer,” the agency said.

European Drug Regulation at Risk of Stalling as Agency Prepares to Leave London

Thu, 10/12/2017 - 13:48

(Nature) – Drug regulation in Europe could temporarily freeze if the European Medicines Agency (EMA) loses staff during its post-Brexit move from London. Up to 70 per cent of its 900 staff have said they would quit if the agency relocated to some of the cities bidding to host the organisation. According to a battle plan drawn up by agency management, failure to retain enough staff would result in a shutdown of essential operations until more people could be hired. If fewer than 30% of the staff move with the agency to its new destination — to be decided next month — it would cease operation, Guido Rasi, the agency’s executive director, told Nature.

Rare Joint Editorial Urges Clinicians to Act on Gun Violence

Thu, 10/12/2017 - 13:36

(Medscape) – The recent mass shooting in Las Vegas was the largest in modern US history, with 59 people dead (58 gunshot victims and 1 shooter suicide) and more than 500 injured. This horrific event has once again highlighted gun violence as a public health crisis in the United States. In a rare joint editorial, written by a group of editors and published in the Annals of Internal Medicine, JAMA, the New England Journal of Medicine, and PLOS Medicine, Darren B. Taichman, MD, PhD, executive deputy editor of the Annals of Internal Medicine and colleagues, share a list of ways in which healthcare professionals can use their skills and voices to address this public health threat. The editorial was published online October 10 in the Annals of Internal Medicine.

Who Will Be the Doctors of Death?

Thu, 10/12/2017 - 13:33

(The Conversation) – Admittedly, palliative care and MAID are both trying to treat suffering, but the methods are different: palliative care does not try to speed up (or slow down) death whereas MAID expressly speeds up death. Palliative care tries to reduce suffering by treating physical, psychosocial and spiritual distress whereas MAID stops suffering by stopping life.

Are People Ready for Human-Made Organs?

Thu, 10/12/2017 - 13:14

(Boston Globe) – What if instead of waiting for a heart transplant, your doctor told you he or she would build you a new one from scratch? That might sound like science fiction, but it’s closer to reality than you might think. On Tuesday, several of the region’s top scientists gathered at the Harvard Club of Boston to discuss the viability of creating organs and other tissues in the laboratory, during a HUBweek presentation titled “The Organ Generation.” Their wide-ranging conversation bounced from the bioethics of organs made by human beings, to how self-driving cars — and the fewer traffic fatalities they promise — might affect the organ donor pipeline.

Military Is Waiting Longer before Force-Feeding Hunger Strikers, Detainees Say

Thu, 10/12/2017 - 13:06

(New York Times) – American military officials at the Guantánamo Bay prison recently hardened their approach to hunger-striking prisoners, detainees have told their lawyers, and are allowing protesters to physically deteriorate beyond a point that previously prompted medical intervention to force-feed them. The claim comes during two significant developments for the military commissions at Guantánamo this week, including a Supreme Court decision on Tuesday not to hear an appeal in a much-watched case.

A New Edition of Nursing Ethics Is Now Available

Thu, 10/12/2017 - 09:00

Nursing Ethics (vol. 24, no. 3, 2017) is available online by subscription only.

Articles include:

  • “What Is Dignity in Prehospital Emergency Care?” by Anna Abelsson and Lillemor Lindwall
  • “Moving It Along: A Study of Healthcare Professionals’ Experience with Ethics Consultations” by Nancy Crigger, Maria Fox, Tarris Rosell, and Wilaiporn Rojjanasrirat
  • “Why the History of Nursing Ethics Matters” by Marsha D Fowler
  • “Legislating for Advocacy: The Case of Whistleblowing” by Chanel L Watson and Tom O’Connor
  • “IJEPA: Gray Area for Health Policy and International Nurse Migration” by Ferry Efend et al.
  • “Access to Services for Young Adults with Medical Complexity” by Elizabeth Joly
  • “The Relationship between Burnout and Mobbing among Hospital Managers” by Seda Karsavuran and S?d?ka Kaya
  • “Clear Conscience Grounded in Relations: Expressions of Persian-Speaking Nurses in Sweden” by Monir Mazaheri et al.
  • “Validation of the Policy Advocacy Engagement Scale for Frontline Healthcare Professionals” by Bruce S Jansson et al.
  • “Participants’ Safety Versus Confidentiality: A Case Study of HIV Research” by Juan Manuel Leyva-Moral and Maria Feijoo-Cid


A New Edition of Hastings Center Report Is Now Available

Thu, 10/12/2017 - 09:00

Hastings Center Report (vol. 47, no. S1, 2017) is available online by subscription only.

Articles include:

  • “Building the Next Bioethics Commission” by Alexander M. Capron
  • “International Capacity-Building Initiatives for National Bioethics Committees” by Eugenijus Gefenas and Vilma Lukaseviciene
  • “Reflections on the National Bioethics Advisory Commission and Models of Public Bioethics” by James F. Childress
  • “Challenges Working with Presidential Bioethics Commissions” by Ruth Macklin
  • “Ethical Principles, Process, and the Work of Bioethics Commissions” by Daniel P. Sulmasy


A New Edition of The New Bioethics Is Now Available

Thu, 10/12/2017 - 09:00

The New Bioethics (vol. 23, no. 1, 2017) is available online by subscription only.

Articles include:

  • “The Promise and the Hype of ‘Personalised Medicine’” by Tim Maughan
  • “Personalised Medicine Approaches to Screening and Prevention” by Kezia Gaitskell
  • “Personalised Medicine and the Economy of Biotechnological Promise” by Steve Sturdy
  • “The Human Dimension: Putting the Person into Personalised Medicine” by Rob Horne
  • “Risk and Benefit in Personalised Medicine: An End User View” by Alastair Kent
  • “Self-Knowledge and Risk in Stratified Medicine” by Joshua Hordern
  • “From Rosalind Franklin to Barack Obama: Data Sharing Challenges and
    Solutions in Genomics and Personalised Medicine” by Mark Lawler and Tim Maughan
  • “Your DNA, Your Say” by Anna Middleton
  • “Data Sharing and the Idea of Ownership” by Jonathan Montgomery
  • “Equity and Value in ‘Precision Medicine’” by Muir Gray, Tyra Lagerberg, and Viktor Dombrádi
  • “Economics of Cancer Medicines: For Whose Benefit?” by Bishal Gyawali and Richard Sullivan


A New Edition of European Journal of Human Genetics Is Now Available

Thu, 10/12/2017 - 09:00

European Journal of Human Genetics (vol. 25, no. 7, 2017) is available online by subscription only.

Articles include:

  • “Expanded Carrier Screening: What Determines Intended Participation and Can This Be Influenced by Message Framing and Narrative Information?” by Jan S Voorwinden et al.
  • “Practices and Views of Neurologists Regarding the Use of Whole-Genome Sequencing in Clinical Settings: A Web-Based Survey” by Iris Jaitovich Groisman, Thierry Hurlimann, Amir Shoham, and Béatrice Godard


A New Edition of Human Reproduction Update Is Now Available

Thu, 10/12/2017 - 09:00

Human Reproduction Update (vol. 23, no. 6, 2017) is available online by subscription only.

Articles include:

  • “Sperm Selection in Natural Conception: What Can We Learn from Mother Nature to Improve Assisted Reproduction Outcomes?” by Denny Sakkas, Mythili Ramalingam, Nicolas Garrido, and Christopher L.R. Barratt
  • ” Diagnosis of Human Preimplantation Embryo Viability” by David K. Gardner, Marcos Meseguer, Carmen Rubio, and Nathan R. Treff


Puerto Rico Investigates Post-Hurricane Disease Outbreak

Wed, 10/11/2017 - 15:19

(STAT News) – Four deaths in Hurricane Maria’s aftermath are being investigated as possible cases of a disease spread by animals’ urine, Puerto Rico’s governor said Wednesday amid concerns about islanders’ exposure to contaminated water. A total of 10 people have come down with suspected cases of leptospirosis, Gov. Ricardo Rossello said at a news conference. On a U.S. territory where a third of customers remain without running water three weeks after the hurricane, some became ill after turning to local streams to relieve their thirst.

Are Stem Cells and Regenerative Medicine Living Up to Their Promises?

Wed, 10/11/2017 - 15:14

(Medical News Today) – The allure of regenerative medicine promises to redefine medical treatment, putting stem cells and biocompatible materials center stage in this revolution. Many breakthroughs have been reported and hailed in scientific journals and the media over the years. However, the number of regenerative medicine treatments in medical use today is disappointingly low, and a panel of commissioners criticizes this lack of progress in a report published last week in The Lancet.

The Rise and Fall and Rise again of 23andMe

Wed, 10/11/2017 - 15:02

(Nature) – 23andme has always been the most visible face of direct-to-consumer genetic testing, and it is more formidable now than ever before. In September, the company announced that it had raised US$250 million: more than the total amount of capital raised by the company since its inception. Investors estimate that it is worth more than $1 billion, making it a ‘unicorn’ in Silicon Valley parlance — a rare and valuable thing to behold. But for scientists, 23andme’s real worth is in its data. With more than 2 million customers, the company hosts by far the largest collection of gene-linked health data anywhere. It has racked up 80 publications, signed more than 20 partnerships with pharmaceutical firms and started a therapeutics division of its own.

Cancer-Genome Study Challenges Mouse ‘Avatars’

Wed, 10/11/2017 - 14:58

(Nature) – An analysis of more than 1,000 mouse models of cancer has challenged their ability to predict patients’ response to therapy. The study, published today in Nature Genetics catalogues the genetic changes that occur in human tumours after they have been grafted into mouse hosts. Such models, called patient-derived xenografts (PDXs), are used in basic research and as ‘avatars’ for individual patients. Researchers use these avatar mice to test a bevy of chemotherapies against a person’s tumour, in the hope of tailoring a treatment plan for the patient’s specific cancer.

Gene Expression Study Raises Thorny Ethical Issues

Wed, 10/11/2017 - 14:53

(Nature) – Ronald’s myriad tissues, and those of almost 1,000 other anonymous deceased donors, are now the basis of a first-of-its-kind database. Supported by the US National Institutes of Health, the US$150-million Genotype-Tissue Expression (GTEx) project is amassing data about gene sequences and activity, and other information, across 44 types of tissue, from blood vessels to 10 different brain regions.  “It’s creating a ‘Google Maps’ of the body,” says Kristin Ardlie, a geneticist at the Broad Institute of MIT and Harvard in Cambridge, Massachusetts, who is part of the project’s data-analysis team. It routinely releases new data, which are freely available to qualified researchers.

Most Versatile Stem Cell Ever May Help Us Understand Miscarriage

Wed, 10/11/2017 - 14:40

(New Scientist) – The most versatile stem cells ever created could enable researchers to better understand the biological mechanisms behind many failed early pregnancies. Pentao Liu of the Sanger Institute in Cambridge, UK, and his team developed the stem cells from cells taken from very young mouse embryos. They gave these cells a cocktail of chemicals to prevent them from maturing, trapping them in a very young, primordial state.