News from Bioethics.com

Authors Retract Controversial NgAgo Gene-Editing Study

3 months 1 week

(Nature) – The Chinese authors of a high-profile gene-editing paper retracted their study yesterday, citing scientists’ inability to replicate the main finding. The paper, published in Nature Biotechnology in May 2016, detailed how an enzyme named NgAgo could be used to knock out or replace genes in human cells by making incisions at precise points on the DNA. The study promised a more versatile alternative to the now ubiquitous CRISPR–Cas9 gene-editing system, which has revolutionized molecular biology and has even been used to fix genes for a heritable heart condition in human embryos.

Researchers Raise ‘Loneliness Epidemic’ as Major Threat to Public Health

3 months 1 week

(UPI) – Holt-Lunstad presented results of two large analyses. In one, researchers analyzed 148 studies that included a total of more than 300,000 people. Those studies linked greater social connection to a 50 percent lower risk of early death. The researchers also reviewed 70 studies involving more than 3.4 million people to gauge the impact of social isolation, loneliness and living alone on the risk of premature death. The conclusion: The effect of the three was equal to or greater than well-known risk factors such as obesity.

U.S. Opioid Crisis Continues to Worsen

3 months 1 week

(Medical Xpress) – Drug overdose deaths continue to climb in the United States, despite efforts to combat the nation’s ongoing opioid addiction crisis, a new federal report states. The drug overdose death rate reached 19.9 cases for every 100,000 people during the late summer of 2016, compared with 16.7 cases per 100,000 the year before, the U.S. National Center for Health Statistics (NCHS) stated in its quarterly mortality report.

First Implant Derived from Stem Cells to ‘Cure’ Type 1 Diabetes

3 months 1 week

(New Scientist) – Last week, two people with type 1 diabetes became the first to receive implants containing cells generated from embryonic stem cells to treat their condition. The hope is that when blood sugar levels rise, the implants will release insulin to restore them to normal. About 10 per cent of the 422 million people who have diabetes worldwide have type 1 diabetes, which is caused by the body’s immune system mistakenly attacking cells in the pancreas that make insulin. For more than 15 years, researchers have been trying to find a way to use stem cells to replace these, but there have been several hurdles – not least, how to get the cells to work in the body.

Who Owns Pre-Embryos?

3 months 1 week

(The New Yorker) – The technology to freeze pre-embryos has been around since the early nineteen-eighties. (In 1984, the first baby from a frozen embryo was born.) By current estimates, there are more than six hundred thousand—some say more than a million—frozen pre-embryos in the United States, and one of the many unanticipated questions stirred by developments in reproductive technology is what to do with them. What happens when couples split up? The frozen pre-embryos aren’t children, but they aren’t exactly property, either. Who decides what happens to them?

11 Organizations Urge Caution, Not Ban, on CRISPR Germline Genome Editing

3 months 1 week

(Genetic Engineering & Biotechnology News) – One day after publication of a landmark study detailing the first-in-the-U.S. use of CRISPR (clustered regularly interspaced short palindromic repeats) to repair a germline mutation in human embryos created through in vitro fertilization, 11 genetics-focused professional organizations are calling for researchers to use caution in applying the technology. The 11 organizations have issued a policy statement stopping short of calling for a ban on human germline genome editing.

Doctor Told to Stop Marketing 3-Person Baby Technique

3 months 1 week

(Yahoo! News) – U.S. regulators on Friday warned a New York fertility doctor to stop marketing an experimental procedure that uses DNA from three people — a mother, a father and an egg donor — to avoid certain genetic diseases. The doctor, John Zhang, used the technique to help a Jordanian couple have a baby boy last year. According to the Food and Drug Administration, Zhang said his companies wouldn’t use the technology in the U.S. again without permission, yet they continue to promote it.

The Global Crackdown on Parents Who Refuse to Vaccines for Their Kids

3 months 2 weeks

(Vox) – There’s a school of thought that refusing vaccines on behalf of your children amounts to child abuse, and that parents should be punished for their decision. We know vaccines are overwhelmingly safe and effective at preventing the spread of disease. And yet failing to immunize children can put them (and vulnerable people around them) at tremendous risk of illness or even death when outbreaks get rolling. Now it seems Australia and a number of countries in Europe are fed up enough with vaccine-refusing parents that they’re experimenting with punitive measures.

Chronic Diseases Spike in Middle East as Conflicts Rage

3 months 2 weeks

(Nature) – Across the Middle East, deaths resulting from violence grew by 850% between 1990 and 2015, according to a series of reports published on 3 August in the International Journal of Public Health. The increase accelerated after 2010, corresponding with the beginning of the Arab Spring movement and wars in Syria and Iraq. At the same time, the authors found, the incidence of many chronic diseases has also risen dramatically; the death rate from diabetes, for instance, grew 216% over the study period. Taken together, the analyses describe a disturbing deterioration in health across a broadly defined Middle Eastern region, which includes 22 countries — including Afghanistan, Iraq, Syria, Somalia and the United Arab Emirates — that are home to more than 580 million people.

Chile’s Congress Eases Strict Abortion Ban, Court Battle Awaits

3 months 2 weeks

(Reuters) – Chile’s Congress approved late on Wednesday night a bill that legalizes abortion in certain cases, though it will still need to win the approval of the nation’s courts to go into effect. After a complex and fractious process, the nation’s Chamber of Deputies voted 70 to 45 to allow abortion when a woman’s life is in danger, when a fetus in unviable, or when a pregnancy results from rape.

Euthanasia Used for 4.5 Percent of Deaths in the Netherlands

3 months 2 weeks

(ABC News) – Euthanasia has become “common practice” in the Netherlands, accounting for 4.5 percent of deaths, according to researchers who say requests are increasing from people who aren’t terminally ill. In 2002, the Netherlands became the first country in the world that made it legal for doctors to help people die. Both euthanasia, where doctors actively kill patients, and assisted suicide, where physicians prescribe patients a lethal dose of drugs, are allowed. People must be “suffering unbearably” with no hope of relief — but their condition does not have to be fatal.

The Opioid Epidemic Explained

3 months 2 weeks

(Vox) – If you want to understand how we got here, there’s one simple explanation: It’s much easier in America to get high than it is to get help. In talking about this, Brandeis University opioid policy expert Andrew Kolodny draws a comparison to New York City’s fight against tobacco. In his telling, the city took a two-prong approach: It made tobacco less accessible — by banning smoking in public spaces and raising taxes to make cigarettes much more expensive. But it also made alternatives to tobacco more accessible — by opening a phone line that people can use to get in touch with a clinic or obtain free nicotine patches or free nicotine gum. It has seen its smoking rate steadily drop, from 21.5 percent in 2002 to 14.3 percent in 2015.

To Grow Market Share, a Drugmaker Pitches Its Product to Judges

3 months 2 weeks

(NPR) – One reason for this preference is that Alkermes, the drug’s manufacturer, is doing something nearly unheard of for a pharmaceutical company: It is marketing directly to drug court judges and other officials. The strategy capitalizes on a market primed to prefer their product. Judges, prosecutors and other criminal justice officials can be suspicious of the other FDA-approved addiction medications, buprenorphine and methadone, because they are themselves opioids. Alkermes promotes its product as “nonaddictive.”

CRISPR Star Jennifer Doudna Calls for Public Debate on Embryo Editing

3 months 2 weeks

(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.

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

3 months 2 weeks

(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’

3 months 2 weeks

(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.

CRISPR Fixes Disease Gene in Viable Human Embryos

3 months 2 weeks

(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.

Gene Editing Is Revolutionizing Medicine But Causing a Government Ethics Nightmare

3 months 2 weeks

(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.

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

3 months 2 weeks

(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.

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

3 months 2 weeks

(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.

Scientists CRISPR the First Human Embryos in the US (Maybe)

3 months 2 weeks

(Wired) – Big if true, as the saying goes. Mitalipov’s group never intended to implant the eggs into a womb, but the embryos were “clinical quality” and probably could have survived implantation. That makes this only the second time scientists anywhere have edited viable embryos—if that’s indeed what Mitalipov did. Maybe this news is important enough to make it to the popular press without a peer-reviewed, published paper, but without one it’s impossible to be definitive on what Mitalipov actually did versus what he’s claiming to have done.

Judge Pulls Controversial Order of Reduced Sentences for Inmates Who Undergo Birth Control Procedures

3 months 2 weeks

(CBS News) – A judge in Tennessee has rescinded a controversial order that offered reduced sentences for inmates who underwent a birth control procedure and completed an educational course about addiction in newborns. Judge Sam Benningfield in White County, Tennessee, initiated the program to combat the rise in infants born addicted to opioids, he told “CBS This Morning” last week. Benningfield said 80 to 90 percent of cases he encounters involve drug or alcohol abuse. The number of babies born with symptoms of withdrawal has increased 10-fold since the early 2000s.

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