Health News – ABC News Radio

Health News – ABC News RadioDrug overdose deaths rose during the 1st months of 2020: CDCThanksgiving safety amid COVID-19: Here’s what you should consider to stay safe#MeToo founder Tarana Burke says group’s new digital platform ‘Act Too’ is ‘an offering directly to survivors’Former ‘Bachelorette’ star Becca Kufrin reveals she’s freezing her eggsRisk of COVID-19 exposure on planes ‘virtually nonexistent’ when masked, study showsDuchess Meghan cautions against social media users becoming addictsSome states raising doubts about federal tests sent to nursing homesBaby born at 1 pound heads home after spending 133 days in hospitalCOVID-19 vaccine: Lessons from 2001’s anthrax attacksHow one hospital organization is tackling racial bias in medicine News and Headlines From ABC News RadioFri, 16 Oct 2020 01:16:49 +0000(c) ABC News Radioen-USSquarespace V5 Site Server v5.13.594-SNAPSHOT-1 ( AudioFri, 16 Oct 2020 01:14:58 +0000
BackyardProduction/iStockBy ERIN SCHUMAKER, ABC News

(ATLANTA) — While news coverage of United States’ opioid epidemic has taken a backseat to the coronavirus this year, new numbers from the Centers for Disease Control and Prevention forecast a grim year for fatal overdoses.

During the first three months of 2020, drug overdose deaths rose 10%, according to preliminary estimates released by the CDC on Wednesday.

Compared to the same period last year, when there were 16,682 overdose deaths, 19,416 Americans died of drug overdoses between January and March of 2020.

In total, the CDC estimates that there will be more than 75,500 fatal overdoses by the end of the year.

White men between the ages of 25 and 64 were more likely to die of drug overdoses than other demographics.

The data are considered preliminary because drug overdose deaths often require lengthy investigations.

When fatal overdoses occur, coroners and medical examiners may initially label death certificates “pending investigation” or “unknown” for the cause of death, according to the agency, and preliminary counts often underestimate the actual number of deaths.

Still, the early data does not paint a full picture of how the pandemic will affect drug overdose fatalities. For many Americans, the pandemic is synonymous with social isolation, financial stress and job loss, medical concerns or deaths among family and friends.

Americans have increasingly reported feeling depressed and anxious since the pandemic began, both of which can be risk factors for substance use.

Copyright © 2020, ABC Audio. All rights reserved.

]]> AudioThu, 15 Oct 2020 14:53:11 +0000
franckreporter/iStockBy KELLY MCCARTHY, ABC News

(NEW YORK) — Thanksgiving is a time to celebrate and be grateful with family and friends, but festivities will likely look different this year due to the pandemic.

“Understanding that everyone has this traditional emotional understandable warm feeling about the holidays and bringing a group of people, friends and family, together in their house indoors, that’s understandable, but we really have to be careful this time,” Dr. Anthony Fauci told chief anchor George Stephanopoulos on Good Morning America Thursday. “Each individual family evaluate the risk-benefit of doing that, particularly when you have people coming in from out of town who may have been on airplanes, in airports to just come into the house.”

Fauci, whose own children won’t be coming home from out of state for the holiday due to the pandemic, added that “if you have vulnerable people, the elderly or people with underlying conditions, you better consider whether you want to do that now or maybe just forestall it and just wait and say, ‘you know, this is an unfortunate and unusual situation, I may not want to take the risk.'”

Ultimately though, Fauci reminded that “it’s up to the individuals and the choices they make.”

The Center for Disease Control and Prevention outlined lower and higher risk activities this year, in which they warned against large indoor gatherings with those outside your immediate household or going shopping in crowded stores around Thanksgiving Day.

But there are still safe and healthy ways to enjoy being with company this holiday. Dr. Bita Nasseri, a leading Mayo Clinic trained physician and her husband, Dr. Shawn Nasseri, dished out their expert opinions for Good Morning America to help anyone still looking to host or attend a Thanksgiving gathering.

How to prepare to get guests safely gathered on Thanksgiving

“The whole point is to be thankful for the experience of being with family and healthy,” Dr. Shawn Nasseri said. “The more you plan in advance the better it’s gonna go for keeping people as safe as possible and minimize everyone else’s exposure.”

Create a checklist for your guests

“This shouldn’t be a drag it could be a pleasant experience knowing that you’re doing something that’s not just protecting you. Your proactivity is helpful to others,” Dr. Bita Nasseri said.

She said hosts should create a COVID symptom checklist for guests to self-assess a few days before the gathering.

“What that means is be very true to yourself and protect yourself to protect others. Go over the COVID symptom list. Sometimes you may forget you have one of those symptoms and you didn’t realize you may be symptomatic,” she said.

Watch out for fever, runny nose, body aches, upset stomach, cough — “if you have any of those symptoms be conscientious and tell others that you’re symptomatic and may not be able to attend.”

“As a host, have a checklist in your head that you’ve checked in with all your guests, assure that they’re asymptomatic before arrival. Set out a table for them to all use hand wipes before entering. Scan their temperature, you’re doing it to protect others. Go through the checklist and make sure you are prepared for hosting. If you know what you’re expecting upon arrival of your guests, you won’t be going out of your comfort zone.”

“Remind invited guests to stay home if they have been exposed to COVID-19 in the last 14 days or are showing COVID-19 symptoms,” the CDC recommended in it’s guidelines for social activities and hosted gatherings.

Optimize outdoor space when possible

“Think outside the box of your normal dining room table,” Bita Nasseri said. “If you can, have the event outdoors,” she suggested, adding that you could put smaller groups “under a covered patio with heaters when needed.”

The CDC said that a “small outdoor dinner with family and friends who live in your community” is considered to be a moderate risk activity.

Give guests room to breathe inside

To minimize possible airborne exposure, both doctors suggested putting one or two air filters in the room where people will gather and open the windows to get natural airflow through the house.

“Fresh air will actually drop the concentration of any kind of germs and microbes that sit around,” Bita Nasseri said. “Fresh air is always good for you.”

Her husband added that air purifiers help with not just respiratory droplets, but to “draw aerosols away from everyone — that’s what we do in medical office buildings.”

At a minimum, they said to arrange seats with three feet of space between guests and arrange multiple tables to separate people in less concentrated crowds.

It won’t be a traditional set up with one big dining room table with six or eight people, so they suggest “getting small tables gathered across multiple rooms” to space out peoples’ proximity.

“Older folks who are more susceptible are in one room and children or younger people are in another room and that way you really minimize the exposure,” he said. “Children could be significantly less symptomatic and not realize that they’re exposing grandparents, great aunts and uncles or anyone who is in a high risk category.”

Reduce contact by swapping out family-style serving

One simple solution to minimize exposure during the meal is to have just one person serving and handling the food and desserts.

“It’s hard because it’s such an emotional connection for most people with the food and preparing the food,” Shawn Nasseri explained. “You’re not gonna keep your aunt from making her favorite stuffing, but what you can do is have one person serving the food.”

The designated person serving the food, the pair suggested, should wear a face mask and gloves while plating to decrease traffic and any possible exposures.

“This is a good year to not use silverware, maybe you can use plastic forks and plates. Have fun with it and limit exposure that way,” she added.

Unlike some germs, there’s no indication coronavirus can spread through food, according to the U.S. Food and Drug Administration.

“There has been no studies that suggest that if a plate of food has been sitting out that it could have the virus,” Bita Nasseri said. “As far as dry, plastic surfaces it has been proven that the virus can transmit up to 72-hours.”

Wear facial coverings when making toasts and greeting others

“If you have seen these people and it’s a less concentrated crowd, then you’re OK as long as you distance yourself,” Bita Nasseri said.

She added that in a larger group she would “require people to wear a face mask” to protect yourself and others, especially if people get hyper and excited when they speak.

Have a backup plan to coordinate virtual visits for guests who can’t make it

“Try to include anyone who is distant. Because of COVID a lot of people will be connected but not in place,” Shawn Nasseri said.

“If anyone hits that checklist and doesn’t feel well,” he continued, “make them a plate, send it to them and then they can Zoom and coordinate it so that everyone eats at the same time.”

Given the opportunity, most loved ones will make the wise decision not to expose their family and friends once they have a moment to review the checklist prior to coming to dinner.

He added that this is the year to send possible at-risk family members a care package and make arrangements for them to connect virtually.

“When you sit down to eat, go around the room and Zoom to say what they’re thankful for — even if we’re in different places and spaces.”

Copyright © 2020, ABC Audio. All rights reserved.

]]> AudioThu, 15 Oct 2020 14:13:00 +0000
Nathan Congleton/NBC/NBCU Photo Bank via Getty ImagesBy HAYLEY FITZPATRICK, ABC News

(NEW YORK) — The #MeToo movement is releasing a new campaign aimed at giving back to survivors on the third anniversary of the now-famous hashtag going viral.

The “Act Too” initiative is a digital platform that contains technology outlining actionable measures one can take or commit to in order to work toward ending sexual violence. The platform relies heavily on community engagement and records each step taken in the fight to advance the #MeToo movement.

Tarana Burke, founder of the #MeToo movement, describes the new campaign as “a labor of love.”

“Act Too is about activating people in ways that are very accessible to do the work of ending sexual violence and interrupting sexual violence,” she explained in an interview with Good Morning America.

She said too much of the brunt of advancing the movement has been put on the backs of survivors.

“When #MeToo first went viral, there was so much energy around it and so much attention paid in various ways, negative and positive, but very little of that attention was directed at the people who actually said #MeToo,” she added.

“This issue that became a huge, hot-button issue had made no offering back to the people who actually made it a movement,” she continued. “There’s no movement without survivors coming forward, and naming their trauma and naming their experience.”

Burke acknowledged that the movement was “being built off the backs of survivors, off the backs of people, out of the labor of people who have already labored enough.”

The activist worked with the team at Toronto-based creative agency, FCB/SIX, to find a way to make the fight against sexual violence more accessible by allowing each person committed to a world without sexual violence to be responsible for their own contributions to the fight.

She wanted those who haven’t been affected by sexual violence to find a way to contribute beyond sharing support for the hashtag.

“I think that what happened is that when something goes viral, it is mainstream — it’s very public in a very specific way,” Burke explained. “So the people who are engaged with it aren’t people who have been committed to the field, or who have studied the issue or who are intimately connected to the issue outside of their personal experience.”

“So when you say movement, they’re like, ‘Oh, what’s the movement? We’ve got to put a hashtag up? Okay, I put the hashtag up. Now what?'” she continued. “And we’re like, ‘No, no … that’s not the movement. Hashtags aren’t movements — they amplify movements.'”

Act Too offers people ways to contribute beyond the hashtag by curating lists of events or causes you can commit to based on your geographic location.

The platform offers recommendations for both tangible actions — volunteering at an event or march — and micro-actions, such as educating oneself with books or films on the subject.

The platform contains a blockchain record of actions taken, which Burke describes as a way for supporters of the #MeToo movement to “create and make and record our own history.”

“A lot of people thought #MeToo going viral was the dawn of a movement to end sexual violence when it was really just another iteration, a furthering of a movement that has been going on for decades,” she explained.

“Part of the reason why people in mainstream didn’t know about that is because nobody is writing that story for us, and the people who tend to write the stories are usually the people who cause the harm and the oppression,” she added. “So if we don’t write our own stories, if we don’t keep track of our own movement, then somebody else will write it.”

Each action taken through Act Too will be represented by a square, and the squares will merge together to form different murals showcasing those who have made contributions to fighting sexual violence.

The rollout of the initiative also coincides with Domestic Violence Awareness month. There has been a dramatic increase in domestic violence reports during the COVID-19 pandemic.

This increase comes at a time when the National Coalition Against Domestic Violence reports nearly 20 people per minute in the United States are physically abused by an intimate partner. The CDC reports nearly 1 in 5 women have experienced completed or attempted rape in their lifetimes, while nearly 1 in 38 men have experienced completed or attempted rape during their lifetimes.

The timing of the new campaign is extremely relevant because so many people across the United States are looking to make an impact right now, she added.

“They are looking for ways to be a part of this,” Burke said. “We are finally having sort of this awakening or reckoning around the idea that if we are not active in this social justice movement then progress won’t happen.”

Copyright © 2020, ABC Audio. All rights reserved.

]]> AudioThu, 15 Oct 2020 14:00:00 +0000
Morsa Images/iStockBy ANDREA TUCCILLO, ABC News

(NEW YORK) — Former Bachelorette star Becca Kufrin isn’t taking any chances when it comes to her fertility.

Following her split from fiancé Garrett Yrigoyen, the 30-year-old revealed in her Instagram Story this week that she’s freezing her eggs.

Kufrin and Yrigoyen appeared in season 14 of the The Bachelorette, and announced their engagement in 2018. On Sept. 1, the former Bachelorette confirmed they’d ended their engagement.

“I think it’s so important as women [that] we know about our bodies and our options,” Kufrin said. “For me, I’m not old but I’m not a spring chicken, and I want kids one day but not anytime soon, so I figure why not do it now in quarantine?”

She documented her first night of injections to begin the process on Tuesday. She plans to share the whole journey for her followers.

Egg freezing is a process that can help to preserve a woman’s fertility, according to the Mayo Clinic. During the process, eggs are harvested from a patient’s ovaries and frozen for use at a later time through in vitro fertilization.

Depending on the age of the patient at the time of egg freezing, the chances of becoming pregnant after a frozen egg is implanted are about 30% to 60%, the Mayo Clinic reported. The older a patient is at the time of egg freezing, the lower the likelihood that it will result in a live birth.

Copyright © 2020, ABC Audio. All rights reserved.

]]> AudioThu, 15 Oct 2020 12:31:35 +0000
United AirlinesBy GIO BENITEZ and SAM SWEENEY, ABC News

(NEW YORK) — United Airlines says the risk of COVID-19 exposure onboard its aircraft is “virtually non-existent” after a new study finds that when masks are worn there is only a 0.003% chance particles from a passenger can enter the passenger’s breathing space who is sitting beside them.

The study, conducted by the Department of Defense in partnership with United Airlines, was published Thursday. They ran 300 tests in a little over six months with a mannequin on a United plane.

The mannequin was equipped with an aerosol generator that allowed technicians to reproduce breathing and coughing. Each test released 180 million particles — equivalent to the number of particles that would be produced by thousands of coughs. They studied the way the mannequin’s particles moved inside the cabin with a mask on and off.

The tests assumed the flight was completely full with technicians placing sensors in seats, galleys, and the jet bridge to represent other passengers on the plane.

“99.99% of those particles left the interior of the aircraft within six minutes,” United Airlines Chief Communication Officer Josh Earnest told ABC News. “It indicates that being on board an aircraft is the safest indoor public space, because of the unique configuration inside an aircraft that includes aggressive ventilation, lots of airflow.”

In late September, major U.S. airline CEOs said their employees were reporting lower rates of COVID-19 infection than the general public.

“At United, but also at our large competitors, our flight attendants have lower COVID infection rates than the general population, which is one of multiple data points that speaks to the safety on board airplanes,” United Airlines CEO Scott Kirby said during a Politico event.

Last week, the International Air Transport Association (IATA) released new research, saying the risk of contracting the virus on a plane appears to be “in the same category as being struck by lightning.”

Among 1.2 billion travelers, IATA found only 44 published cases of potential inflight transmission. Most of those 44 cases occurred in the early days of the pandemic when masks were not required.

Air travel is still down around 70 percent compared to last year, but there has been an uptick since the spring. Earlier this week the Transportation Security Administration (TSA) screened nearly a million people at U.S. airports — the agency’s highest number since mid-March.

“We’re seeing recovery, but we have a long way to go,” Earnest said. “And even with all of this promising information about the safety of air travel and some of the advances that we’re making in terms of implementing a testing regimen – we recognize we’re not going to be anywhere close to back to normal until we have a vaccine that’s been widely distributed and administered.”

Copyright © 2020, ABC Audio. All rights reserved.

]]> AudioWed, 14 Oct 2020 15:29:06 +0000
bigtunaonline/iStockBy KATIE KINDELAN, ABC News

(NEW YORK) — Duchess Meghan, who was active on social media before marrying Prince Harry, said she has been offline for “a very long time” and worries about the addictive nature of social media.

“For my own self-preservation, I have not been on social media for a very long time,” the Duchess of Sussex said Tuesday in a virtual chat with Fortune magazine for its “Most Powerful Next Gen Summit. “I had a personal account years ago, which I closed down and then we had one through the institution and our office that was in the U.K. that wasn’t managed by us — that was a whole team — and so I think that comes with the territory for the job you have.”

“I’ve made a personal choice to not have any account, so I don’t know what’s out there, and in many ways that’s helpful for me,” added Meghan, who, with Harry, closed their popular Sussex Royal Instagram account when they stepped down from their senior roles with Britain’s royal family earlier this year and could no longer use the Sussex Royal name.

Meghan, 39, also described social media as an “addiction,” noting the similarities to a drug addiction.

“I have a lot of concerns for people that have become obsessed with it, and it is so much a part of our daily culture for so many people that it’s an addiction like many others,” she said. “There are very few things in this world where you call the person who is engaging with it a user.”

“But if you look at social media and what it’s doing in the same capacity, as it does in creating addiction. What is the comp there? People who are addicted to drugs are called users and people who are on social media are called users,” Meghan added. “There is something algorithmically that is in there that is creating this obsession that I think is very unhealthy for a lot of people.”

In her remarks, which were shared on Fortune magazine’s social media accounts, Meghan advised people to be “really conscious and responsible” on social media.

“Just be conscious of what you’re doing and understand that it is not limited to that one moment, that you are creating an echo chamber for yourself, so the more that you engage with things that are negative, not just for other people that you might not know, but what it’s doing to you as a human being will really have lasting effects, and that there is an alternative to engaging in that kind of stuff,” she said. “I would say to just be really conscious and responsible.”

Meghan also spoke directly to young women, saying, “I don’t think people have even started to scratch the surface on what this is doing to us, and I wish more for especially the younger generation of women, you have the power to turn this around.”

Meghan spoke to Fortune virtually from the Santa Barbara, California, home that she, Harry and their 1-year-old son Archie recently moved into.

The women’s rights activist and former actress described how being a mother has changed her leadership style.

“It’s interesting because my gut is that it makes you more courageous, it makes you so concerned for the world they’re going to inherit,” she said. “So the things you’re able to tolerate on your own are not the same that you are going to put your child in a position of vulnerability for. You go every single day –how can I make this world better for Archie? That is a shared belief for my husband and I.

“At the same time, I am cautious of putting my family at risk by certain things. I try to be very clear in what I say and not get controversial and instead talk about things that seem very straight forward, like exercising your right to vote,” Meghan said. “I think that’s as simple as it comes and as necessary as it comes and to that point as a parent, I can enjoy all the fun and silliness and games with my son, but I wouldn’t be able to feel proud of myself as a mom if I didn’t know that I wasn’t doing my part to make it a better place for him.”

Copyright © 2020, ABC Audio. All rights reserved.

]]> AudioWed, 14 Oct 2020 12:46:38 +0000
filadendron/iStockBy LAURA ROMERO, ABC News

(NEW YORK) — Several states have curtailed using coronavirus testing equipment in nursing homes that was provided by the Trump Administration after concerns were raised about the results, including false positives that risk mistakenly sending vulnerable seniors into special COVID isolation wings that could ultimately expose them to the virus.

Since July, the administration had been rushing out the machines from manufacturers Becton, Dickinson and Company and Quidel to more than 14,000 facilities around the country in an attempt to identify outbreaks faster and stem the tide of the virus, which has taken a particular toll on the elderly, especially those in nursing homes and other assisted living facilities.

“We have a real crisis around testing,” said Dr. Michael Osterholm, an epidemiologist and director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “We don’t have the capacity to supply every facility with … the more reliable and accurate tests and the tests we do have are not accurate and unreliable.”

The machines process cheaper-to-produce kits known as antigen tests — which can yield results in 15 minutes. While other diagnostic tests for COVID-19 like PCR tests look for genetic material from the virus, antigen tests look for molecules on the surface of the virus, diagnosing an active coronavirus infection faster than molecular tests.

Although they are not perfect, many experts view these tests as an important component in the effort to fight COVID-19. The rapid turnaround time means they can be used in bulk to screen dozens of people in quick succession, with any potentially positive cases later confirmed with a more accurate PCR test. These are the tests, for instance, that the White House requires everyone to take before they enter the complex.

“Antigen tests may be a better screening tool than a diagnostic tool,” said Dr. Mark Abdelmalek, an ABC News medical contributor. “It is a helpful way to screen many at risk people, especially if done frequently. Antigen tests may not be the best at telling you who has COVID, but they can be very helpful for telling you who is likely to transmit COVID.”

Abdelmalek added that while antigen tests may not be as sensitive as molecular tests, they play a role in controlling the pandemic because of their ease, speed and potentially lower cost. The idea behind sending them to nursing homes, he said, was so rapid tests could serve as an early warning system, even though they might not find every case.

High rates of false positives in some cases

Some states are reporting that these tests, which have produced a rate of false negative results as high as 50%, according to an article published by the American Association for the Advancement of Science, are now also yielding false positives, an outcome of deeper concern to state health officials.

This was the case last week in Nevada, where health officials announced they would discontinue the use of antigen tests provided by the Centers for Medicare & Medicaid Services after state data reported that 60% of a sample from 60 positive antigen tests from 12 facilities of positives were false.

Days after announcing the halt, Nevada health officials grudgingly reversed course under pressure from the federal government, directing nursing homes to restart their use of the rapid coronavirus tests on Friday.

“We are very disappointed by the letter received today from the [Adm. Brett] Girior,” the federal health official who oversaw the distribution of testing equipment to nursing homes, said Dr. Ihsan Azzam, Nevada’s chief medical officer in a statement to health care providers.

“If this laboratory data discrepancy had been reported to Dr. Girior, we would hope he would have taken the same action as Nevada to protect our vulnerable population and ensure no further harm occurred while we further conducted our investigation,” Azzam said. “We too want more testing with rapid turnaround in Nevada, but the results of those tests must be accurate as they affect clinical care.”

On a call with reporters on Friday, Giroir said that all tests will have false positives.

“These are expected and appropriate, especially for screening tests when used in populations with a low prevalence of infection,” Giroir told reporters. “Bottom line, the recommendations in the Nevada letter are unjustified and not scientifically valid.”

Others sound the alarm

Nevada has not been alone in sounding alarms about the federal testing kits. Several states told ABC News they are also reevaluating the antigen testing equipment, with many of them saying they are providing nursing facilities with more accurate molecular tests, known as PCR (polymerase chain reaction) tests, that can take two to three days to process, assuming no backlog.

According to the FDA, PCR tests were designed to minimize false positives.

Andrews Wojcik, a spokesperson for the Office of Health and Risk Communication in Delaware told ABC News that results from antigen tests showed a “concerning percentage of false positives.” He said the state is following recommendations from the Centers for Disease Control and Prevention (CDC) to make sure any positive test result using antigen testing in a long-term care facility will be supplemented with a follow-up PCR test and sent for priority processing at the state laboratory.

A spokesperson for the health department in Pennsylvania said they too have experienced “a small subset of tests where false positivity was a concern in our long-term care facilities.” And in Oregon, the department of health says it is re-evaluating testing guidance regarding the antigen testing kits “given the reports of false positive results nationally and planning internal validation studies.”

”We are also investigating any reports of false positive results in Oregon,” said Dr. Melissa Sutton, the medical director of respiratory viral pathogens at the Oregon Health Authority.

Other states are also relying on their own system using the more accurate PCR tests to screen nursing homes for the virus. Av Harris, a spokesperson for the Connecticut Department of Public Health told ABC News the state is only using PCR tests in long-term care facilities. The state began testing nursing homes with the PCR tests before the antigen tests were sent to states by the federal government.

“Since June, Connecticut set up a state-funded comprehensive nursing home testing program for residents and staff that uses PCR tests with locally based labs who can guarantee timely processing of samples for quicker results with no backlog,” Harris said.

State officials from Arkansas, New Jersey Wisconsin and Minnesota told ABC News they are also primarily using routine PCR tests in long-term care facilities.

“This approach avoids many of the challenges associated with antigen testing,” said Elizabeth Goodsitt, a spokesperson for the Wisconsin Department of Health Services.

Doug Schultz, a spokesperson for the Minnesota Department of Health said that “if a long term facility is able to meet their testing needs with PCR testing, that is generally recommended.”

Five states including California and Arizona told ABC News that they do not have reports of widespread problems with false results from antigen testing machines.

False positives were a surprise

When the Food and Drug Administration (FDA) authorized the rapid testing equipment from BD and Quidel, it acknowledged there was a higher chance of false negatives but did not mention false positives.

But in July, the FDA sent a letter to health care providers, alerting them of an increased risk of false positive results from the BD testing kits. The agency recommended confirming the initial result with an alternate type of authorized test.

“The FDA is aware of reports of false positive antigen tests in nursing homes,” said a spokesperson for the FDA on Tuesday. “We will continue to monitor and evaluate these reports and other available information about device safety and performance.”

The letter noted that in one study, the manufacturer found approximately 3% of results were false positive results. BD, the trade name of the New Jersey-based medical supplier Becton, Dickinson and Company, has said they have “full confidence” in their testing equipment.

“We believe the test is performing as intended in Nevada – rapidly detecting true positives to help reduce the risk of an outbreak among some of the nation’s most vulnerable individuals,” said Kristen Cardillo, BD’s vice president of global communication.

A spokesperson for Quidel told ABC News in a statement that “complaints of discordance are extremely rare.”

“We activate Quidel’s rigorous Quality Control Management System and conduct a thorough analysis to determine the root cause of the alleged discordance,” the statement stated. “Once our investigation is complete, we address any issues identified — such as inadequate training and improper handling. We have yet to see a problem with the test product to date.”

The false positives from antigen tests have raised concerns among health experts, who worry nursing homes will see an increase in infected residents.

“A positive test triggers action in these facilities,” said Emily Gurley, an epidemiologist and contact tracing expert at the Johns Hopkins Bloomberg School of Public Health. “The staff member must isolate and quarantine all of their contacts. If the person is truly positive, these are prudent steps. If the test was a false positive, these actions are unnecessary disruptions and burdens.”

Similarly, Geoffrey Baird, the acting laboratory-medicine chair at the University of Washington told ABC News that many facilities use testing to “co-locate” infected patients.

“If you mistakenly identify a non-infected person as infected, you would put a non-infected person in contact with infected people, potentially infecting them or worse,” Baird said.

“Long-term care facilities need to know if residents have COVID-19 or not and these tests are just too unreliable,” said Dr. Osterholm, the director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “If you can’t trust the results, it’s a real challenge.”

Copyright © 2020, ABC Audio. All rights reserved.

]]> AudioWed, 14 Oct 2020 12:34:05 +0000
Tulane Health SystemBy NICOLE PELLETIERE, ABC News

(NEW YORK) — A micro preemie who was born at just 1 pound has defied the odds after doctors determined he had little chance of survival.

Russell Appold Jr. was treated at Tulane Lakeside Hospital in Louisiana after his mother went into labor at 22 weeks pregnant. Russell fought 133 days in the neonatal intensive care unit and finally arrived home on Oct. 1.

“If it wasn’t for them and God, I don’t think he would be here,” mom Natasha Williams told ABC News’ Good Morning America. “They are so sweet and became our family. … We cried quite a bit when we had to say goodbye.”

Williams, now a mother of three, said when trying to have Russell she was pregnant three times, but none of the babies had heartbeats.

“It was so scary when I found out we were pregnant with [Russell], we didn’t want everyone to get their hopes up,” Williams added. “When we went to the doctor they said the baby had a strong heartbeat.”

At 15 weeks pregnant, Williams’ cervix started to open up. She had emergency surgery and a procedure to stop her from going into labor.

But on May 20, Williams went into preterm labor. Doctors told her it was likely that Russell would not make it.

“My fiance and I both cried and we started praying,” Williams said. “My water broke on Wednesday and I gave birth to him on a Friday at about 10:55.”

Williams and her fiance, Russell Appold Sr., welcomed Russell Appold Jr. on May 22. Her original due date was Sept. 22.

“Our experience in caring for Russell was both extremely powerful and humbling,” said Tulane neonatologist Lisa Barbiero.

Barbiero said that since 2017, medical professionals discuss resuscitation down to 22 weeks with “appropriate parental counseling and input.”

“We are in competition with fetal lung embryology,” she added. “There does come a point when the lung is too immature to function on its own without the placenta assisting in gas exchange. While the odds are still against these babies at the borderline of viability we have seen dramatic improvements in survival (5% to nearly 20% in some situations) of infants born at less than 23 weeks when the entire team from high risk OB care to neonatology is onboard with supporting a family’s request for attempts at resuscitation.”

After Russell was born, medical staff administered breathing tubes. He experienced jaundice and blood on his brain, but through the months he healed and so far, has beaten the odds.

Russell now weighs over 8 pounds. The hospital gave him a surprise sendoff to mark the end of his NICU stay.

Williams has since started a Facebook page titled, Baby Russell’s Journey. She created it for families who have babies in the NICU or women who want to talk through postpartum adjustments.

Copyright © 2020, ABC Audio. All rights reserved.

]]> AudioTue, 13 Oct 2020 16:50:49 +0000

(NEW YORK) — As the race for a COVID-19 vaccine continues, the first vaccines are likely to reach the public through a regulatory pathway specifically intended for emergency situations.

If that happens, it won’t be the first time in recent history that the Food and Drug Administration has granted an Emergency Use Authorization for a potentially promising vaccine. An EUA was granted during the anthrax attacks in 2001.

The anthrax attacks, which killed five people and harmed 22, underlined the need for a reliable anthrax vaccine. The U.S. government had been working on a vaccine for decades, which had already been used in a limited context for some members of the military.

In the wake of the anthrax attacks, postal workers — viewed as particularly vulnerable — were offered the government’s vaccine. But there were many questions about the vaccine that remained unanswered, as well as the feeling by some of the workers that they were being used as “lab monkeys” or “guinea pigs,” and that “management would do anything” to get the mail out, according to findings in the 2008 report, The Anthrax Vaccine and Research: Reactions from Postal Workers and Public Health Professionals.

Ultimately, very few postal workers opted to take the vaccine.

A few years after the attacks, the FDA’s Emergency Use Authorization program was established as part of the Project BioShield Act, and in 2005, the FDA granted emergency authorization for the anthrax vaccine.

Despite the authorization, the general public did not have access to the vaccine. Instead, the FDA specifically authorized the vaccine’s use in adults aged 18 to 65 who were deemed by the Department of Defense to be at heightened risk of exposure.

The FDA should have a “really good” reason to make a vaccine available immediately, said Dr. Joshua Sharfstein, former deputy commissioner of the FDA, now professor of the practice at Johns Hopkins Bloomberg School of Public Health, when speaking during a public Q&A with the JAMA Network last month.

The baseline requirements of an EUA are: There must be an emergency; the potential benefits of the product must exceed the risks; and there must be reasonable belief that “the product may be effective,” according to the FDA.

“COVID-19 qualifies as an emergency on the scale to justify the use of this procedure,” said Dr. Paul Wilson, an expert on vaccine development, and assistant professor of clinical population and family health at Columbia University’s Mailman School of Public Health.

“Given the guidance on what evidence will be required for a vaccine EUA, I think people’s concern should be on the potential for political pressure rather than on the EUA process per se,” Wilson said.

Scientists worry that pressure from President Donald Trump to issue an EUA prior to the general election on Nov. 3 could undermine public trust. However, the FDA has said that it plans to request two months of safety data from COVID-19 vaccine developers prior to requesting an EUA, seemingly quashing worries about a rushed “October surprise.”

And the agency has promised that its EUA standards will not compromise normal safety or efficacy steps.

“Both the FDA and the vaccine companies seem to be trying hard to restore confidence, and the recent guidance from the FDA seems completely reasonable. I’m also somewhat reassured by the fact that both FDA and companies will feel pressure to release the data on which a decision is based, which will give independent experts a chance to weigh in,” Wilson told ABC News.

Public trust in a new vaccine hinges on trust in the government and in the credibility of the public health institutions, as well as on people’s perceptions about the government’s underlying motives to accelerate its release to the public, some experts concede.

“Concerns about vaccine safety, mistrust and fears about motivations for vaccination, perceived lack of a clear recommendation,” can result in low participation in an inoculation program, wrote University of Maryland Professor Sandra Quinn, chair of the department of family science and senior associate director of the Maryland Center for Health Equity.

In 2009, during the H1N1 pandemic, Quinn conducted a survey which found that people were much more reluctant to take an “authorized” rather than fully “approved” vaccine. Only 8.7% of the respondents said that they would definitely be willing to take it, while 63.5% indicated they would not take it. Almost 28% were undecided.

Race was significantly associated with vaccine reluctance. Only 4.2% of Black Americans stated that they would take such a novel vaccine, an attitude which the study attributes to the impact of deep mistrust stemming from medical experiments, such as the Tuskegee syphilis study.

“Our finding that the majority of people would not accept a new but not yet fully approved vaccine is very worrisome,” concluded Quinn, in 2009.

Now, some experts are warning that the same fate could be in store for any COVID-19 vaccine granted emergency use authorization, and caution that anti-vaccine sentiments are stronger today than a decade ago.

Public confidence in a potential COVID-19 vaccine remains concerningly low. According to a recent Axios/Ipsos poll, 60% of Americans say they are not likely to get a first-generation COVID-19 vaccine as soon as it’s available, with only 39% saying they are likely to get it.

“There’s a lot at stake here,” said Wilson. “The approval of a vaccine on shaky grounds or without the whole-hearted endorsement of the public health community would accelerate the erosion of faith in vaccines in general, which would be tragic.”

Copyright © 2020, ABC Audio. All rights reserved.

]]> AudioMon, 12 Oct 2020 13:30:09 +0000