The World Health Organization (WHO) warns healthy pregnant women are undergoing unnecessary medical interventions at an alarming rate. Given the trend, WHO is launching new recommendations aimed at reducing potentially harmful interventions.

The organization reports most of the estimated 140 million annual births occur without complications. Yet, it says over the past 20 years there has been a significant rise in medical interventions previously used to avoid risks. These include oxytocin infusion to speed up labor and caesarean sections.

WHO says health providers tend to intervene medically when the rate of labor appears to be slower than what is considered normal. This is based on a long-held benchmark for cervical dilation to occur at a rate of one centimeter per hour.

Olufemi Oladapo, a medical officer in WHO’s department of Reproductive Health and Research, says every labor and childbirth is unique, and it is perfectly normal for some women to be slower than the prescribed rate of cervical dilation.

He says WHO has set another boundary for cervical dilation of up to five centimeters per hour during the first stage of labor until the woman is ready to push out the baby.

“It should not be longer than 12 hours in first-time mothers. And it should not be longer than 10 hours in subsequent labors…. So, as long as a woman is making some progress within that time frame, and the condition of the mother as well as the baby are reassuring, then there should be no reason for intervening,” Oladapo said.  

WHO warns unnecessary labor and potentially harmful routine medical interventions are rampant in all parts of the world – in poor and rich countries alike. WHO’s new guidelines include 56 evidence-based recommendations on best care for mother and baby during labor and immediately after.

These include permitting a woman to have a companion of choice present during labor and childbirth; ensuring good communication between women and health providers; and allowing women to make decisions about their pain management, labor and birth positions.

 
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The first blood test to help doctors diagnose traumatic brain injuries has won U.S. government approval.

The move means Banyan Biomarkers can commercialize its test, giving the company an early lead in the biotech industry’s race to find a way to diagnose concussions.

The test doesn’t detect concussions and the approval won’t immediately change how patients with suspected concussions or other brain trauma are treated. But Wednesday’s green light by the Food and Drug Administration “is a big deal because then it opens the door and accelerates technology,” said Michael McCrea, a brain injury expert at Medical College of Wisconsin.

The test detects two proteins present in brain cells that can leak into the bloodstream following a blow to the head. Banyan’s research shows the test can detect them up within 12 hours of injury. It’s designed to help doctors quickly determine which patients with suspected concussions may have brain bleeding or other brain injury.

Patients with a positive test would need a CT scan to confirm the results and determine if surgery or other treatment is needed. The test will first be used in emergency rooms, possibly as soon as later this year, but Banyan’s hope is that it will eventually be used on battlefields and football fields.

FDA Commissioner Dr. Scott Gottlieb said the test fits with the agency’s goals for delivering new technologies to patients and reducing unnecessary radiation exposure.

The test “sets the stage for a more modernized standard of care for testing of suspected cases,” Gottlieb said in a statement.

Traumatic brain injuries affect an estimated 10 million people globally each year; at least 2 million of them are treated in U.S. emergency rooms. They often get CT scans to detect bleeding or other abnormalities. The scans expose patients to radiation, but in many patients with mild brain injuries including concussions, abnormalities don’t show up on these imaging tests.

With Department of Defense funding, Banyan’s research shows its Brain Trauma Indicator can accurately pick up brain trauma later found on CT scans. It also shows that absence of the two proteins in the test is a good indication that CT scans will be normal. That means patients with negative blood tests can avoid CT scans and unnecessary radiation exposure, said Dr. Jeffrey Bazarian, a University of Rochester emergency medicine professor involved in Banyan’s research.

Bazarian called the test “a huge step” toward devising a blood test that can detect brain injuries including concussions.

Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, and other brain injury experts say the test isn’t sensitive enough to rule out concussions.

“This may be a beginning. It’s not the pot of gold at the end of the rainbow,” Koroshetz said.

That prize would be a test that could detect and guide treatment for concussions and traumatic brain injuries, similar to a blood test that hospitals commonly use to evaluate suspected heart attacks, Koroshetz said.

“That’s what we’d like to have for the brain,” he said.

San Diego-based Banyan has partnered with French firm bioMerieux SA to market the test to hospitals using that company’s’ blood analyzing machines.

Other companies are developing similar blood tests to detect brain injuries. Abbott has licensed both protein biomarkers from Banyan and is developing its own blood tests. BioDirection is developing a test involving one of the proteins in Banyan’s test plus another one and using a portable device that can yield results from a single drop of blood in less than two minutes.

Quanterix is also working to develop a blood test to diagnose concussions and other brain injuries. It has licensed the use of both proteins in Banyan’s test to be used with its own technology.
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A Texas elementary school teacher who died almost a week after getting sick from the flu became a talking point online after her husband said she didn’t immediately fill her prescription for an antiviral drug after deeming the $116 insurance co-pay too high.

While her husband told the Wall Street Journal that he picked up the prescription the day after she refused it and she then started taking the medication, Heather Holland, 38, died three days later on Feb. 4. 

Doctors told The Associated Press that while it’s ideal to start taking antiviral medication as quickly as possible, it’s no guarantee that one’s condition will not drastically worsen.

Antivirals make it “not zero, but less likely” that complications will develop, said Dr. William Schaffner, infectious diseases specialist at the Vanderbilt University Medical Center in Nashville, Tennessee, who added, “antivirals are not a magic potion.”

Frank Holland of Willow Park, just west of Fort Worth, told the newspaper that his wife, a second-grade teacher, came home feeling a bit sick Jan. 29. The mother of two went to work in nearby Weatherford on Jan. 30 but by evening had a fever. 

She went to the doctor on Jan. 31. Frank Holland said a rapid flu test was positive for influenza B. The doctor wrote her a prescription for oseltamivir phosphate, a generic form of the antiviral medication Tamiflu.

Frank Holland told the Wall Street Journal that they had the money, but she was frugal and didn’t want to fill it. 

She went to a Fort Worth hospital on Feb. 2. The following day, blood tests showed she had sepsis, a complication of infections, he said.

Antiviral drugs – when taken within 48 hours after becoming sick – can lessen symptoms, shorten the time one is sick by about one day and reduce complications. 

“There are people who are going to do very well, regardless of getting Tamiflu or not. There are people that are going to do very poorly, regardless of getting Tamiflu or not. And then there’s kind of the middle segment of the population where Tamiflu really may push them to the right outcome,” said Dr. Luis Ostrosky, an infectious disease expert with McGovern Medical School at UTHealth and Memorial Hermann-Texas Medical Center in Houston.

Dr. Trish Perl, chief of infectious diseases at UT Southwestern Medical Center in Dallas, said that “in some cases it may be useful” to give patients an antiviral even after the 48-hour onset. 

The Centers for Disease Control and Prevention said the flu shot is the best way to prevent seasonal flu. Frank Holland said he couldn’t remember whether she got a flu shot this season. Generally, he said, they’ve both been “pretty healthy.”
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When stockpiles of yellow fever vaccine run low, partial doses are effective, according to a new study.

The report on the vaccine, which currently is in short supply, comes as officials in Brazil attempt to contain an outbreak with what they describe as the largest-ever mass vaccination campaign using partial doses.

Yellow fever is a mosquito-borne viral disease found in tropical Africa and South and Central America. Severe cases can cause jaundice and death, but most cases involve fever, muscle pain and vomiting.

Congo outbreak, experiment

During a major outbreak in the Democratic Republic of the Congo in 2016, the government aimed to prevent the disease from spreading in the capital, Kinshasa. Health officials launched a mass vaccination campaign targeting 7.6 million people.

But the outbreak had depleted vaccine stockpiles. Hoping to stretch the available supply, the World Health Organization reviewed the small number of available studies on using reduced doses and recommended using one-fifth of a dose per person.

It seemed to work.

Researchers took blood samples from more than 700 people before and after they received the partial dose. In the new study, published in the New England Journal of Medicine, nearly all of those vaccinated with the lower dose developed enough antibodies to the virus to prevent infection.

“That was the encouraging thing, that this can be done as a potential way — when there’s supply limitations on the vaccine — to help potentially control an outbreak,” said study co-author Erin Staples at the U.S. Centers for Disease Control and Prevention.

Hundreds infected

More than 350 people have become infected with yellow fever in Brazil since late last year, and health officials have launched a campaign targeting nearly 24 million people with a one-fifth dose of the vaccine.

Staples says the new study is good news for controlling outbreaks like Brazil’s in the short term. But, she notes, “We still need some information about how long immunity will last.”

A full dose of yellow fever vaccine provides lifelong immunity. Researchers will continue to study how long people who received partial doses are protected.
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Two babies, born 15 months apart to the same young woman overcoming opioid addiction. Two very different treatments.

 

Sarah Sherbert’s first child was whisked away to a hospital special-care nursery for two weeks of treatment for withdrawal from doctor-prescribed methadone that her mother continued to use during her pregnancy. Nurses hesitated to let Sherbert hold the girl and hovered nervously when she visited to breast-feed.

 

Born just 15 months later and 30 miles away at a different South Carolina hospital, Sherbert’s second child was started on medicine even before he showed any withdrawal symptoms and she was allowed to keep him in her room to encourage breast-feeding and bonding. His hospital stay was just a week.

 

“It was like night and day,” Sherbert said.

 

The different approaches highlight a sobering fact: The surge has outpaced the science, and no one knows the best way to treat the opioid epidemic’s youngest patients.

 

Trying to cope with the rising numbers of affected infants, hospitals around the United States are taking a scattershot approach to treating the tremors, hard-to-soothe crying, diarrhea and other hallmark symptoms of newborn abstinence syndrome.

 

“It’s a national problem,” said Dr. Lori Devlin, a University of Louisville newborn specialist. “There’s no gold-standard treatment.”

 

With help from $1 million in National Institutes of Health funding, researchers are seeking to change that by identifying the practices that could lead to a national standard for evidence-based treatment. A rigorous multi-center study comparing treatments and outcomes in hard-hit areas could start by the end of this year, said Dr. Matthew Gillman, who is helping lead the effort.

 

“When there’s so much variability in practice, not everyone can be doing the very best thing,” Gillman said.

 

Once the umbilical cord is cut, babies born to opioid users are at risk for developing withdrawal symptoms. By some estimates, one infant is born with the condition in the U.S. every 25 minutes. The numbers have tripled since 2008 at a rate that has solid medical research comparing treatments and outcomes struggling to keep pace.

 

Not all opioid-exposed babies develop the syndrome, but drug use late in a pregnancy increases the chances and can cause dependence in fetuses and newborns. These infants are not born with addiction, which experts consider a disease involving compulsive, harmful drug-seeking behavior. But the sudden withdrawal of opioids from their mothers may cause increased production of neurotransmitters, which can disrupt the nervous system and overstimulate bodily functions. Symptoms can last for months.

 

The condition can result from a mother’s use of illicit drugs, but it also can stem from mothers being prescribed methadone or other anti-addiction medicine. Doctors believe the benefits of that treatment for the mothers outweigh any risks to their infants.

 

The Centers for Disease Control and Prevention doesn’t routinely track the condition, but the agency’s most recent data — from 2014 — indicates that the syndrome affects nearly 11 in every 1,000 U.S. births. The CDC said it is working with the March of Dimes and several states to get a better picture of the number of affected infants and how they fare developmentally and academically into childhood.

 

Some studies have suggested possible increased risks for developmental delays and behavior problems, but no research has been able to determine if that’s due to mothers’ drug use during pregnancy, infants’ treatment after birth or something completely unrelated. And there’s no definitive evidence that these children fare worse than unexposed youngsters.

 

“It’s very, very frustrating” not knowing those answers, Devlin said. “It’s such a difficult population to go back and do research on. They’re people who often don’t trust the system, often people who have had lots of trauma in their lives.”

 

Treatment aims to reduce or even prevent symptoms. Some hospitals use morphine drops, while others use methadone and sometimes sedatives. Some send the babies straight to newborn intensive care units and some focus on comfort care from moms, allowing them to room-in with their infants. A recently published Dartmouth-Hitchcock Medical Center analysis linked rooming-in with less medication use and shorter hospital stays for infants, but it can be difficult if mothers are still in the throes of addiction.

 

A Florida hospital is even testing tiny acupuncture needles on affected infants.

 

Many hospitals use a 40-year-old scoring system to measure 21 symptoms and frame diagnosis and treatment length, but some have created their own scales.

 

The Government Accountability Office’s health care team has called for federal action to address the issue, saying the current recommendations from the U.S. Health and Human Services Department amount to a half-baked strategy lacking priorities and a timeline for implementation.

 

The department’s recommendations include education for doctors and nurses to teach them how to manage affected infants, along with an emphasis on non-drug treatment.

 

Katherine Iritani, director of the GAO’s health care team, said government officials have since indicated that they are convening experts to develop and finalize a plan by March 15.

 

“We’ll review it and make sure it’s responsive to our recommendations,” she said.

 

A separate GAO report released last week recommended beefed-up government guidance to help states implement programs that ensure safe care for opioid-affected infants and treatment for parents still struggling with drug use.

 

Medicaid pays for more than 80 percent of costs for treating affected babies, totaling about $1 billion in 2012, the GAO has found.

 

At Greenville Memorial Hospital, where Sarah Sherbert’s son was delivered two years ago, babies born to methadone users are given that drug before symptoms start and are sent home with a supply to continue treatment.

 

Clemson University research has showed that approach could reduce hospital stays by nearly half, to an average of eight days costing $11,000 compared with the state average of 15 days at a cost of $45,000.

 

“The baby has already been exposed to methadone for nine months so adding four to five weeks and making weaning gentle instead of quitting cold turkey we think won’t have any additional effect on babies’ brain development,” said Dr. Jennifer Hudson, who developed the treatment approach.

 

Sherbert, 31, said her drug use began eight years ago after she was prescribed opioid painkillers for injuries from a car accident. She was on methadone prescribed by her doctor when her daughter, now 3, was born.

 

She later lost custody after relapsing and her parents are caring for the children. Sherbert said she has been sober for a year and recently was promoted to supervisor at her job. She said she’s determined to get them back.

 

“I’ve worked so hard and come such a long way,” she said. “Seeing their little faces — that’s worth every bit of it.”

 

 

 
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