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CRISPR Star Jennifer Doudna Calls for Public Debate on Embryo Editing

Bioethics News - Thu, 08/03/2017 - 14:50

(San Diego Union-Tribune) – Doudna said she wasn’t cognizant of the ethical issues when she and collaborator Emmanuelle Charpentier began exploring CRISPR. Beyond the call for society to grapple with the ramifications of germline editing, Doudna said, it’s difficult to get more specific, except to exercise general caution.In many cases, genetic defects don’t even need to be repaired if multiple embryos are being generated, she said. These embryos could simply be screened for genetic defects, and a healthy embryo would be chosen. “In my opinion, we still need to respect the recommendations in the (National Academy of Sciences) report published in February that recommended refraining from clinical use of human germline editing until and unless there’s broad societal consensus about the value,” Doudna said.

Elective Freezing of IVF Embryos Linked to Higher Pregnancy Rates in Some Cases

Bioethics News - Thu, 08/03/2017 - 14:46

(Medical Xpress) – A delay in transferring embryos to the mother improves the success of in vitro fertilization in certain cases, according to a study by scientists at the Stanford University School of Medicine, Celmatix Inc. and several other institutions. Women undergoing IVF who have high levels of the hormone progesterone when their egg cells are retrieved benefit from having the resulting embryos frozen and transferred back to the uterus at a later date, the researchers found. The study appears in the August issue of Fertility and Sterility.

After French Drug Trial Tragedy, European Union Issues New Rules to Protect Study Volunteers

Bioethics News - Thu, 08/03/2017 - 14:40

(Science) – The European Medicines Agency (EMA) has issued new, stricter rules for studies that test drugs in people for the first time. They aim to better protect participants in such first-in-human studies—often healthy volunteers who receive a financial reward. The guideline, which was issued on 25 July, will take effect in February 2018. It comes in the wake of a tragedy in a French drug study last year that led to the death of one man and serious neurological damage in four others. But some say the revision isn’t going for enough.

Drug Puts a $750,000 ‘Price Tag on Life’

Bioethics News - Wed, 08/02/2017 - 15:01

(NPR) – But that common hope has taken them down different paths: In April, Gundy’s child, who is on private insurance, began getting the drug Spinraza, which costs $750,000 for the initial year of treatment. Chaffin’s child, a Medicaid enrollee, did not, as his state regulators debated whether to offer it to children like him who use ventilators to breathe. Across the country, similar stories are playing out as private insurers and already-squeezed state Medicaid programs wrestle with what, if any, limits to place on patients’ access to break-the-bank drugs — weighing the needs of the ill against budget realities.

Clinical Trial Fails to Disclose Risk of Death, Repeat Heart Attacks, Group Says

Bioethics News - Wed, 08/02/2017 - 14:54

(Miami Herald) – A clinical trial testing blood transfusion therapies for heart attack patients may place participants in danger of death or a repeat heart attack without fully disclosing those risks, a Washington, DC-based consumer advocacy group said Tuesday in a letter asking federal health officials to immediately suspend enrollment in the study, which is recruiting patients at dozens of hospitals, including Mount Sinai Medical Center in Miami Beach.

Rhode Island Now Requires Coverage to Ensure Fertility

Bioethics News - Wed, 08/02/2017 - 14:47

(ABC News) – Rhode Island has enacted a law that requires insurers to cover “fertility preservation” for patients who undergo medical treatments that could leave them sterile. The legislation is believed to be the first of its kind in the country. The Providence Journal reports the legislation was designed to help cancer patients of childbearing age who may be rendered infertile by chemotherapy treatments.

CRISPR Fixes Disease Gene in Viable Human Embryos

Bioethics News - Wed, 08/02/2017 - 14:24

(Nature) – An international team of researchers has used CRISPR–Cas9 gene editing — a technique that allows scientists to make precise changes to genomes with relative ease — to correct a disease-causing mutation in dozens of viable human embryos. The study represents a significant improvement in efficiency and accuracy over previous efforts. The researchers targeted a mutation in a gene called MYBPC3. Such mutations cause the heart muscle to thicken — a condition known as hypertrophic cardiomyopathy that is the leading cause of sudden death in young athletes. The mutation is dominant, meaning that a child need inherit only one copy of the mutated gene to experience its effects.

Many Still Sidestep End-of-Life Care Planning, Study Finds

Bioethics News - Wed, 08/02/2017 - 14:21

(Kaiser Health News) – Not everyone is as motivated to tackle these issues. Even though advance directives have been promoted for nearly 50 years, only about a third of U.S. adults have them, according to a recent study. People with chronic illnesses were only slightly more likely than healthy individuals to document their wishes. For the analysis, published in the July issue of Health Affairs, researchers reviewed 150 studies published from 2011 to 2016 that reported on the proportion of adults who completed advance directives, focusing on living wills and health care power-of-attorney documents.

Gene Editing Is Revolutionizing Medicine But Causing a Government Ethics Nightmare

Bioethics News - Wed, 08/02/2017 - 14:15

(Newsweek) – Late last week, reports emerged that scientists in Oregon had used gene-editing technology, known as CRISPR-Cas9, to edit a human embryo. While research like this is already occurring in China and Great Britain, this is the first time scientists in the U.S. have edited an embryo. The move raises the question of whether regulations are strict enough in the U.S. Both Congress and the National Institutes of Health have explicitly said they would not fund research that uses gene-editing to alter embryos. But laws and guidelines are not keeping pace with this fast-moving and controversial work.

The FDA Wants to Cut Cigarettes’ Nicotine Levels. Will that Help People Quit?

Bioethics News - Wed, 08/02/2017 - 14:08

(STAT News) – For the first time in history, the Food and Drug Administration plans to regulate the level of nicotine in cigarettes, attempting to bring it down to “non-addictive” levels. The move, announced Friday, was praised by scientists — who also noted that there’s no consensus on what a “non-addictive” level of nicotine is.

A New Edition of The New England Journal of Medicine Is Now Available

Bioethics News - Wed, 08/02/2017 - 09:00

The New England Journal of Medicine (vol. 376, no. 16, 2017) is available online by subscription only.

Articles include:

  • “Reevaluating Eligibility Criteria — Balancing Patient Protection and Participation in Oncology Trials” by J.A. Beaver, G. Ison, and R. Pazdur
  • “A Citizen’s Pathway Gone Astray — Delaying Competition from Generic Drugs” by R. Feldman and C. Wang

 

A New Edition of JAMA Is Now Available

Bioethics News - Wed, 08/02/2017 - 09:00

JAMA (vol. 317, no. 15, 2017) is available online by subscription only.

Articles include:

  • “Revamping the US Federal Common Rule: Modernizing Human Participant Research Regulations” by James G. Hodge Jr. and Lawrence O. Gostin
  • “The Hyde Amendment at 40 Years and Reproductive Rights in the United States: Perennial and Panoptic” by Eli Y. Adashi and Rachel H. Occhiogrosso

 

A New Edition of JAMA Internal Medicine Is Now Available

Bioethics News - Wed, 08/02/2017 - 09:00

JAMA Internal Medicine (vol. 177, no. 7, 2017) is available online by subscription only.

Articles include:

  • “Effect of a Price Transparency Intervention in the Electronic Health Record on Clinician Ordering of Inpatient Laboratory Tests: The PRICE Randomized Clinical Trial” by Mina S. Sedrak et al.

 

A New Edition of The New England Journal of Medicine Is Now Available

Bioethics News - Wed, 08/02/2017 - 09:00

The New England Journal of Medicine (vol. 376, no. 17, 2017) is available online by subscription only.

Articles include:

  • “Beyond Genes and Molecules — A Precision Delivery Initiative for Precision Medicine” by R.B. Parikh, J.S. Schwartz, and A.S. Navathe

 

A New Edition of JAMA Is Now Available

Bioethics News - Wed, 08/02/2017 - 09:00

JAMA (vol. 317, no. 17, 2017) is available online by subscription only.

Articles include:

  • “Types and Distribution of Payments From Industry to Physicians in 2015” by Kathryn R. Tringale et al.
  • Association Between Academic Medical Center Pharmaceutical Detailing Policies and Physician Prescribing” by Ian Larkin et al.

 

Better Drugs, Faster: The Potential of AI-Powered Humans

Bioethics News - Tue, 08/01/2017 - 15:50

(BBC) – Scientists working in tandem with artificial intelligence (AI) could slash the time it takes to develop new drugs – and, crucially, the cost – say tech companies. Developing pharmaceutical drugs is a very expensive and time-consuming business. And as AstraZeneca found out last week, disappointing drug trials can knock millions off your stock market value in a flash. So the faster we can identify promising molecules that could be turned into viable drugs, the better. This is why pharmaceutical companies, such as GlaxoSmithKline (GSK), Merck, Sanofi and Johnson & Johnson, are now turning to artificial intelligence (AI) to help them.

Super-Intelligence and Eternal Life: Transhumanism’s Faithful Follow It Blindly into a Future for the Elite

Bioethics News - Tue, 08/01/2017 - 15:26

(The Conversation) – But there is a darker side to the naive faith that Pearce and other proponents have in transhumanism – one that is decidedly dystopian. There is unlikely to be a clear moment when we emerge as transhuman. Rather technologies will become more intrusive and integrate seamlessly with the human body. Technology has long been thought of as an extension of the self. Many aspects of our social world, not least our financial systems, are already largely machine-based. There is much to learn from these evolving human/machine hybrid systems.

Will Healthcare Inequality Cause Genetic Diseases to Disproportionately Impact the Poor?

Bioethics News - Tue, 08/01/2017 - 15:20

(Gizmodo) – Prenatal testing is a miraculous technology that has drastically altered the course of a woman’s pregnancy since it was first developed in the 1960s. The more recent advent of noninvasive prenatal tests made the procedure even less risky and more widely available. Today, most women are offered screenings for diseases like Down syndrome that result from an abnormal presence of chromosomes, and targeted testing of the parents can hunt for inherited disease traits like Huntington’s at risk of being passed on to a child, as well. But there is a dark side to this miracle of modern medicine, which is that choice is exclusive to those who can afford and access it.

Study: Stem Cells May Help Aid Corneal Wound Healing

Bioethics News - Tue, 08/01/2017 - 15:12

(UPI) – A new study has found the use and transplantation of stem cells in corneal wound healing to improve the healing process and benefit patients, researchers report. Researchers at Cedars Sinai Medical Center found that by using corneal stem cells they could more effectively treat corneal injuries from burns, abrasions, contact lens problems, insufficient tear production, infections and other conditions.

A Surprising Amount of Medical Research Isn’t Made Public. That’s Dangerous.

Bioethics News - Tue, 08/01/2017 - 14:51

(Vox) – When the results of clinical trials aren’t made public, the consequences can be dangerous — and potentially deadly. Consider the case of the anti-depressant Paxil, produced by the drug company SmithKline Beecham (now part of GlaxoSmithKline). GSK got approval from the FDA in 1999 for treatment of depression in adults, but not in teenagers. That meant that while doctors could prescribe the drug to adolescents — a so-called “off label” prescription — GSK could not promote the drug to doctors for that purpose.

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