News from Bioethics.com

Behind the Scenes of a Radical New Cancer Cure

3 weeks 1 hour

(Undark) – Today, two FDA-approved CAR-T products called Kymriah and Yescarta are available in more than 100 hospitals collectively across the U.S. Hundreds of clinical trials are tinkering with dosages, patient populations, and types of cancer. Some medical centers are manufacturing the cells on-site. The FDA approved CAR-T with a drug safety program called a Risk Evaluation and Mitigation Strategy (REMS). As I cared for these patients, I quickly realized the FDA’s concerns. Of the 10 or so patients I’ve treated, more than half developed strange neurologic side effects ranging from headaches to difficulty speaking to seizures to falling unconscious. We scrambled to learn how to manage the side effects in real time.

Deaf Couple May Edit Embryo’s DNA to Correct Hearing Mutation

3 weeks 2 hours

(Science) – Yevgenievna and her husband, who is partially deaf, want to have children who will not inherit hearing problems. There is nothing illicit about our discussion: Russia has no clear regulations prohibiting Rebrikov’s plan to correct the deafness mutation in an in vitro fertilization (IVF) embryo. But Yevgenievna is uneasy about publicity. “We were told if we become the first couple to do this experiment we’ll become famous, and HBO already tried to reach me,” Yevgenievna says. “I don’t want to be well known like an actor and have people bother me.” She is also deeply ambivalent about the procedure itself, a pioneering and potentially risky use of the CRISPR genome editor.

Women Giving Birth in Low-Income Countries Often Endure Abuse

3 weeks 1 day

(Reuters) – Women are often mistreated during labor and delivery at hospitals in low-income countries, a new study suggests.  During in-person observations of births at urban hospitals in Ghana, Guinea and Nigeria, researchers found that more than 40 percent of women experienced physical or verbal abuse, stigmatization or discrimination related to race or ethnicity, according to a report in The Lancet. Surveys of women who had recently given birth in those countries and in Myanmar yielded similar findings.

‘The Worst Public Health Crisis in Decades’: First Federal Opioid Trial Slated to Begin Monday

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(USA Today) – The landmark opioid litigation pitting state and local governments against makers and distributors of the highly addictive painkillers is set to go to trial Monday after attempts at a settlement broke down last week. An offer of $48 billion in cash, treatment drugs and services was rejected as lawyers for the 2,400 cities and counties involved clashed with states attorneys general over the distribution of the settlement.

A New Crispr Technique Could Fix Almost All Genetic Diseases

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(Wired) – A few months later, his idea found a home in the lab of David Liu, the Broad Institute chemist who’d recently developed a host of more surgical Crispr systems, known as base editors. Anzalone joined Liu’s lab in 2018, and together they began to engineer the Crispr creation glimpsed in the young post-doc’s imagination. After much trial and error, they wound up with something even more powerful. The system, which Liu’s lab has dubbed “prime editing,” can for the first time make virtually any alteration—additions, deletions, swapping any single letter for any other—without severing the DNA double helix. “If Crispr-Cas9 is like scissors and base editors are like pencils, then you can think of prime editors to be like word processors,” Liu told reporters in a press briefing.

Evidence Links Poliolike Disease in Children to a Common Type of Virus

3 weeks 2 days

(Science) – Researchers seeking the cause of mysterious cases of childhood paralysis seem to be closing in on a culprit. Since 2014, more than 500 children in the United States have suddenly lost muscle control in their arms and legs, a condition called acute flaccid myelitis (AFM), which can cause permanent disability. But the leading explanation—that a normally mild viral infection occasionally results in AFM—has been hard to prove. A new analysis of young patients’ spinal fluid now offers evidence linking a group of common viruses known as enteroviruses to AFM. But questions remain about how such viruses damage nerves and why they seem to do so only rarely.

The Ebola Outbreak Is Finally Slowing Down

3 weeks 2 days

(Nature) – The Ebola outbreak in the eastern Democratic Republic of the Congo (DRC) is finally waning, the World Health Organization (WHO) said on 18 October. The good news came as a vaccine that has helped to contain the virus’s spread moved a step closer to regulatory approval. Fifty people were diagnosed with Ebola in the DRC between 25 September and 15 October, the WHO said. At the outbreak’s peak in April, roughly 300 new infections were reported in three weeks. Since the outbreak began in August 2018, almost 3,250 people have been infected and more than 2,150 have died.

Scientists ‘May Have Crossed Ethical Line’ in Growing Human Brains

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(The Guardian) – Neuroscientists may have crossed an “ethical rubicon” by growing lumps of human brain in the lab, and in some cases transplanting the tissue into animals, researchers warn. The creation of mini-brains or brain “organoids” has become one of the hottest fields in modern neuroscience. The blobs of tissue are made from stem cells and, while they are only the size of a pea, some have developed spontaneous brain waves, similar to those seen in premature babies. Many scientists believe that organoids have the potential to transform medicine by allowing them to probe the living brain like never before. But the work is controversial because it is unclear where it may cross the line into human experimentation.

Russian ‘CRISPR-Baby’ Scientist Has Started Editing Genes in Human Eggs with Goal of Altering Deaf Gene

3 weeks 2 days

(Nature) – Russian biologist Denis Rebrikov has started gene editing in eggs donated by women who can hear to learn how to allow some deaf couples to give birth to children without a genetic mutation that impairs hearing. The news, detailed in an e-mail he sent to Nature on 17 October, is the latest in a saga that kicked off in June, when Rebrikov told Nature of his controversial intention to create gene-edited babies resistant to HIV using the popular CRISPR tool.

DNA Tests for Psychiatric Drugs Are Controversial But Some Insurers Are Covering Them

3 weeks 5 days

(NPR) – Companies that make genetic tests like the one Gruman used say they can save patients and doctors from prolonged searching for the right medication and save insurance companies from paying for ineffective drugs. But many researchers say the tests don’t have enough evidence backing them up. The Food and Drug Administration has warned that the tests could potentially steer patients towards the wrong medications. Nonetheless, UnitedHealthcare, the nation’s largest insurer, began covering them October 1 for its 27 million individual and group plans.

WHO Hails ‘Triumph’ as Merck’s Ebola Vaccine Gets European Green Light

3 weeks 5 days

(Reuters) – The world’s first Ebola vaccine was recommended for approval by European drugs regulators on Friday in a move hailed by the World Health Organization (WHO) as a “triumph for public health” that would save many lives. The vaccine, developed by U.S. drugmaker Merck & Co, is already being used under emergency guidelines to try to protect people against the spread of a deadly Ebola outbreak in Democratic Republic of Congo. 

Sanofi Pulls Zantac from U.S. and Canada After Carcinogen Found

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(Reuters) – Sanofi SA said on Friday it would recall popular heartburn medicine Zantac in the United States and Canada, after the medicines were linked with a probable cancer-causing impurity. The French drugmaker said it was working with health authorities to determine the level and extent of the recall, which it called a precautionary measure being taken due to possible contamination with a substance called N-nitrosodimethylamine (NDMA). 

An ‘Unprecedented’ Analysis Underlines Profound Failure to Study African Genomes

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(STAT News) – The genomes of the 50 groups, the most ever analyzed in such detail in a single study, each had unique genetic variants, underlining why the Human Genome Project does such a poor job of representing Africa. Although some 70% of the sequence in the “reference genome” the project produced came from an African-American man living in Buffalo, N.Y., a single individual of African ancestry can no more encompass the diversity of African DNA than one page of Shakespeare can show the diversity of Western literature.

Genetic Testing Kits ‘May Wrongly Reassure Those at Risk of Cancer’

3 weeks 5 days

(The Guardian) – Consumer genetic tests could be giving false reassurance to those at heightened risk of cancers, according to findings presented at an international conference this week. The study, by clinical genetic testing company Invitae, revealed that tests for breast and bowel cancer risk by direct-to-consumer companies such as 23andMe give negative results to the vast majority of those carrying DNA mutations in the genes under investigation.

‘Fear of Falling’: How Hospitals Do Even More Harm by Keeping Patients in Bed

3 weeks 6 days

(Kaiser Health News) – Falls remain the leading cause of fatal and nonfatal injuries for older Americans. Hospitals face financial penalties when they occur. Nurses and aides get blamed or reprimanded if a patient under their supervision hits the ground. But hospitals have become so overzealous in fall prevention that they are producing an “epidemic of immobility,” experts say. To ensure that patients will never fall, hospitalized patients who could benefit from activity are told not to get up on their own — their bedbound state reinforced by bed alarms and a lack of staff to help them move.

We Found Over 700 Doctors Who Were Paid More Than a Million Dollars by Drug and Medical Device Companies

3 weeks 6 days

(ProPublica) – Back in 2013, ProPublica detailed what seemed a stunning development in the pharmaceutical industry’s drive to win the prescription pads of the nation’s doctors: In just four years, one doctor had earned $1 million giving promotional talks and consulting for drug companies; 21 others had made more than $500,000. Six years later — despite often damning scrutiny from prosecutors and academics — such high earnings have become commonplace. More than 2,500 physicians have received at least half a million dollars apiece from drugmakers and medical device companies in the past five years alone, a new ProPublica analysis of payment data shows. And that doesn’t include money for research or royalties from inventions.

How Netflix Led the Way on Abortion Rights in Hollywood

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(CNN) – For Netflix, it marked a major moment of leadership in the industry — but a potentially risky one, too. In coming out against Georgia’s ban, Sarandos raised the bar for where Netflix would do business, essentially putting all jurisdictions (not just Georgia) on notice: The company wouldn’t film in places with laws that didn’t match up with its values. But that positioning could one day put Netflix in a bind. The company has been expanding its global footprint to places like the Middle East, where abortion access is restricted. Eventually, it will have a choice to make: does it apply those values consistently, or risk looking hypocritical?

Secret Abortions Spike in Nigeria with Boko Haram Chaos

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(Reuters) – The Johns Hopkins University estimates that 2.7 million abortions are carried out in Nigeria each year, the majority performed secretly and in dangerous conditions, with poor, uneducated women most at risk. Health and aid workers say unsafe abortions have surged in northern Nigeria since the start of the Boko Haram conflict in 2009, which has driven 1.8 million Nigerians from their homes, according to the United Nations.

Calling Embryo Editing ‘Premature,’ Russian Authorities Seek to Ease Fears of Scientist Going Rogue

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(STAT News) – Russian health officials are playing down international concerns that a Moscow researcher plans to create gene-edited babies any time soon, saying for the first time that the experiment would be “premature.” Denis Rebrikov, the scientist who has said he wants to use the genome-editing technology CRISPR to alter embryos, has sparked widespread alarm among scientists who fear that he could become the second researcher to conduct such work, following the birth of gene-edited twins in China last year.

Where You Die Can Affect Your Chance of Being an Organ Donor

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(Associated Press) – Henry’s case illustrates troubling uncertainty in a transplant system run by government contractors that are under fire for letting potentially usable organs go to waste. The Associated Press took a close look at that system and calculated that some of those agencies are securing deceased donors at half the rate of others — even as 113,000 people linger on the nation’s transplant waiting list, and about 20 die each day.

When Medical Debt Collectors Decide Who Gets Arrested

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(ProPublica) – Across the country, thousands of people are jailed each year for failing to appear in court for unpaid bills, in arrangements set up much like this one. The practice spread in the wake of the recession as collectors found judges willing to use their broad powers of contempt to wield the threat of arrest. Judges have issued warrants for people who owe money to landlords and payday lenders, who never paid off furniture, or day care fees, or federal student loans. Some debtors who have been arrested owed as little as $28. More than half of the debt in collections stems from medical care, which, unlike most other debt, is often taken on without a choice or an understanding of the costs. Since the Affordable Care Act of 2010, prices for medical services have ballooned; insurers have nearly tripled deductibles — the amount a person pays before their coverage kicks in — and raised premiums and copays, as well. As a result, tens of millions of people without adequate coverage are expected to pay larger portions of their rising bills.

Questions Remain Over Puberty-Blockers, as Review Clears Study

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(BBC) – Over the past year, there have been mounting criticisms of a study into the effects of puberty-blocking drugs when used to treat young people with gender dysphoria – including concerns raised by Newsnight.  The study was carried out at the Gender Identity Development Service (Gids) at London’s Tavistock Clinic – England’s only NHS youth gender clinic – and partly led to the clinic lowering the age at which it offers children puberty blockers. The clinic started recruiting young people to the study in 2011.

E-Cigarettes Went Unchecked in 10 Years of Federal Inaction

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(The New York Times) – E-cigarettes and vaping devices, with $7 billion in annual sales, have become a part of daily life for millions of Americans. Youth use has skyrocketed with the proliferation of flavors targeting teenagers, such as Bazooka Joe Bubble Gum and Zombie Blood. And nearly 1,300 people have been sickened by mysterious vaping-related lung injuries this year. Yet the agency has not vetted the vast majority of vaping devices or flavored liquids for safety. In dozens of interviews, federal officials and public health experts described a lost decade of inaction, blaming an intense lobbying effort by the e-cigarette and tobacco industries, fears of a political backlash in tobacco-friendly states, bureaucratic delays, and a late reprieve by an F.D.A. commissioner who had previously served on the board of a chain of vaping lounges.

Young Blood May Hold the Weapons for Targeting Age-Related Diseases

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(Chemical & Engineering News) – In the wake of the initial fervor surrounding young blood, researchers are taking a more measured approach. Rather than trying to reverse aging, they’re identifying the molecular factors responsible for the changes seen in parabiosis experiments in hopes of targeting specific diseases associated with aging, such as age-related macular degeneration or Alzheimer’s disease. “Right now, conducting a clinical trial for aging is extremely difficult,” says Eric Verdin, CEO of the Buck Institute for Research on Aging. A targeted approach could yield practical treatments more quickly and with fewer ethical and other concerns than simply transfusing patients with young blood, researchers say.

Amazon Joins Trend of Sending Workers Away for Health Care

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(The Wall Street Journal) – Employers are increasingly going the distance to control health spending, paying to send workers across the country to get medical care and bypassing local health-care providers. One of the latest is Amazon.com Inc., which will pay travel costs for workers diagnosed with cancer who choose to see doctors at City of Hope, a Los Angeles-area health system. More than 380,000 of the Seattle-based company’s employees and families across the U.S. are eligible for the travel benefit.

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