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FDA Approves A Drug For A Rare Disease That Causes Children To Age Quickly : Shots

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Sam Berns and Audrey Gordon, executive director of The Progeria Research Foundation and Berns’s aunt, attend The New York Premiere Of HBO’s “Life According To Sam” on October 8, 2013 in New York City.

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Sam Berns and Audrey Gordon, executive director of The Progeria Research Foundation and Berns’s aunt, attend The New York Premiere Of HBO’s “Life According To Sam” on October 8, 2013 in New York City.

Thos Robinson/Getty Images for HBO

The Food and Drug Administration has approved a drug that extends the lives of children with an extremely rare genetic disorder that causes them to grow old before they grow up.

The disorder, progeria, ages cells rapidly and prematurely. As a result, affected children remain small and begin to look frail and old by the time they reach school age. Most die of heart disease in their early teens.

But the drug, Zokinvy, slows down the decline.

“Zokinvy is a treatment. It’s not a cure,” says Dr. Leslie Gordon, an assistant professor of pediatrics at Brown University and medical director of The Progeria Research Foundation. “But what we can say is that, so far, we know that it increases the average lifespan by about two-and-a-half years.”

Gordon and her family played a crucial role in making Zokinvy possible.

Their goal was to find a treatment for Gordon’s son, Sam Berns, who was diagnosed with progeria in 1998 and died in 2014.

“We started this for Sam, and Sam is always here, always,” Gordon says.

Sam Berns gave a TEDx talk about living with progeria.

YouTube

As a teenager, Sam became the public face of progeria. He spoke to NPR and other media about his condition, was the subject of an HBO documentary, and gave a TEDx talk about how to live a happy life that has been viewed more than 40 million times.

Sam was one of the first children with progeria to receive Zokinvy and Gordon says the drug seemed to extend her son’s life.

“I think Sam felt that way,” she says. “And looking at the data, and as parents, we felt that way too.”

Since Sam’s death, his family has continued to operate The Progeria Research Foundation and to search for a cure.

“We make a really great team,” says Audrey Gordon, who is Sam’s aunt and the foundation’s president. “Leslie [is] in charge of the science aspect, I’m in charge of the fundraising and her husband, Scott, is the chairman of the board.”

Experimental Drug Is First To Help Kids With Premature-Aging Disease

The approach reflects a philosophy embraced by Sam, who was a big sports fan, Audrey Gordon says.

“Whenever someone asked, who’s your favorite player on your beloved Patriots or your Boston Bruins, he always refused because he felt like it wasn’t any one person who made the team,” she says “It was the team as a whole.”

Team Sam published the first evidence that Zokinvy worked in 2012. But getting FDA approval required a whole new

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health 

Cases of Covid-19 in children on rise in the US, with highest 1-week spike yet

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Soaring case counts around the country are impacting children at “unprecedented levels,” according to new numbers released Monday by the American Academy of Pediatrics and the Children’s Hospital Association, which are tracking data reported by state health departments.



a police car parked in a parking lot: An attendant talks to a person waiting in their car at a coronavirus testing site October 31 in El Paso, Texas.

© Cengiz Yar/Getty Images
An attendant talks to a person waiting in their car at a coronavirus testing site October 31 in El Paso, Texas.

There were 61,000 new cases in children during the last week of October, “which is larger than any previous week in the pandemic,” the AAP said in a statement. From the onset of the pandemic through October 29, more than 853,000 children have tested positive for Covid-19, the AAP said, including nearly 200,000 new cases during the month of October.

“This is a stark reminder of the impact this pandemic is having on everyone — including our children and adolescents,” said AAP President Dr. Sally Goza in the statement.

“This virus is highly contagious, and as we see spikes in many communities, children are more likely to be infected, too,” Goza said.

Yet these numbers are likely an undercount, the AAP said. Because symptoms in children are often mild and can look like common colds or viruses, many children go untested.

Symptoms in children

Typical symptoms of Covid-19 in both children and adults include a fever of 100 degrees Fahrenheit or higher, a dry cough, difficulty breathing, headaches, digestive issues, body aches and fatigue, runny nose, sore throat and sneezing.

Unusual symptoms can include “Covid toes” — a reddish tinge to toes and other extremities, a sudden loss of taste and smell and conjunctivitis, a highly contagious condition also known as pink eye.

However, early research has suggested children may not get fever, cough or shortness of breath as often as adults. Fever and cough was found in 56% and 54% of children in one study, compared to 71% and 80% of adults, according to the US Centers for Disease Control and Prevention. Shortness of breath was found in only 13% of pediatric patients, compared to 43% of adults. Sore throat, headache, muscle pain, fatigue and diarrhea were also less commonly reported in children.

While cases of severe illness due to Covid-19 appears to be rare among children, severe illness has been reported, most often in infants less than a year.

When children did need to be hospitalized, the CDC found, one in three needed to be treated in the intensive care unit — the same rate as for adults.

Long-term effects not known

Adolescents between the ages of 12 and 17, according to an early October report by the CDC, were about twice as likely to test positive for Covid-19 than kids between 5 and 11 years old.

More severe cases of Covid-19 were most likely to be found in children with underlying health conditions, the CDC said, with chronic lung disease, including asthma, the most commonly reported condition (55%). While in smaller percentages, children with disability (9%), immune disorders (7%), diabetes (6%), psychological conditions

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health 

Johnson & Johnson to test coronavirus vaccine in children

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Pharmaceutical giant Johnson & Johnson has plans to begin testing its coronavirus vaccine on children, according to Reuters. 

Reuters reported on Friday the company soon plans to test the experimental vaccine candidate on people aged 12 to 18. 

Our country is in a historic fight against the Coronavirus. Add Changing America to your Facebook or Twitter feed to stay on top of the news.

“We plan to go into children as soon as we possibly can, but very carefully in terms of safety,” Jerald Sadoff, senior advisor with Johnson & Johnson’s vaccine division, said during a meeting held by the Centers for Disease Control and Prevention (CDC) Friday, according to Reuters. 

Sadoff said the company also has plans to test the vaccine in children younger than 12 if it’s shown to be safe among those 12 to 18. 

Most COVID-19 vaccine trials are focused on whether the shots are safe and effective in adults. Pfizer, which has manufactured one of the four vaccine candidates currently in phase three trials in the U.S., recently started testing its vaccine candidate in children. 

While far fewer children have been sick with COVID-19 compared to adults, they can still become infected with the virus and spread it around to others. 

Johnson & Johnson kicked off phase three trials of its vaccine last month, aiming to enroll 60,000 participants. The company had to pause the trial earlier this month after a participant suffered a stroke. An independent committee investigated the incident and determined the incident was not related to the vaccine and the trial resumed this week. 

It’s not unusual for some participants to become ill during large scale vaccine trials and most resume shortly after they’re put on pause so cases can be evaluated for safety.

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health 

First Response Pregnancy Test Survey Reveals Women Are Putting Off Having Children Due to Increased Uncertainty During COVID-19

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OB/GYN Mary Jane Minkin, M.D. offers advice to address pregnancy anxieties

According to a new First Response survey about the current family planning goals of 3,000 US women aged 18-35, nearly 20% say they’re uncertain of their trying to conceive (TTC) plans while 38% are intentionally putting off conceiving during the pandemic due to anxiety and stress. Mary Jane Minkin, Clinical Professor of Obstetrics & Gynecology at Yale Medical School tells women to follow simple safety measures when considering getting pregnant during this unprecedented time.

“Women are understandably facing a lot of anxiety when considering their family planning journey and many are waiting for a vaccine before starting or growing their family,” says Minkin. “However, if the time is right to have a baby, go ahead and book an appointment with a medical provider, take extra precautions, utilize telehealth appointments, and implement precautions based on the advice from healthcare providers.”

Dr. Minkin offers the following advice to address pregnancy related anxieties:

  1. Book a preconception appointment. OB-GYN’s, doctors, and nurse practitioners are available via phone and in person to answer all questions and health concerns. If you need help finding a healthcare provider, contact your nearest hospital clinic, community health center external icon, or health department. Medical visits can also be handled virtually by scheduling a telehealth appointment, which can be helpful to address any questions you may have.

  2. When unsure, take a pregnancy test. Stress and anxiety can trigger symptoms that mimic those of pregnancy, like morning sickness, food cravings, mood swings, and fatigue – so the best way to know if pregnant is to use a reliable pregnancy test like First Response Early Result so you don’t need to leave the house until COVID-19 settles down. A test can be revealing up to six days before a missed period. Be sure to call your doctor right away if the test is positive to put a proper plan of action in place.

  3. Be wary of listening to friends or relying on Dr. Google. While the experiences of others or the internet can hold insights, when it comes to making important personal health decisions make sure to consult a medical professional to confirm whether what you’ve been told or read is really true. Other reliable online sources include ACOG.org, CDC.gov, and WHO.int.

  4. Stay current on all vaccines. Pregnancy can alter the immune system and lead to an increased risk of respiratory infections. A flu shot can help mom and baby by causing the body to create protective antibodies (proteins produced by the body to fight off diseases.) The whooping cough (Tdap) vaccine will help protect your baby against whooping cough, which can mimic symptoms of COVID-19.

  5. Maintain overall health. Make sure to have at least a 30-day supply of the medicines you need on hand, stop smoking, eat healthy foods and supplement with folic acid. Try an easy to take pre-natal vitamin like the vitafusion gummy vitamin. It is also important to avoid alcohol and limit caffeine intake

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health 

Pediatricians say nearly 800K children have had coronavirus

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Almost 800,000 children in the U.S. have been infected by COVID-19 this year, the American Academy of Pediatrics (AAP) said Monday, adding that current cases among children are rising.

In their latest state-level data report, the AAP shared statistics that demonstrate a growing prevalence of coronavirus among youth.

Currently there are about 8.4 million cases of the coronavirus in the U.S., with children now making up 11 percent of that number — about 1,053 cases per 100,000 kids.

During the period from Oct. 8 to Oct. 22, there were 4,555 new youth cases reported, a 14 percent increase.

So far, deaths and hospitalizations among children diagnosed with the coronavirus have been quite rare. Only 1 percent to 3.6 percent of total reported hospitalizations were kids, and children made up 0 percent to 0.23 percent of reported deaths stemming from COVID-19. Sixteen states reported that no children had died as a result of the virus.

The AAP based their findings on reports from 49 states, New York City, Washington, D.C., Puerto Rico and Guam.  

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health 

Self-blame Reduces Qol for Parents of Food-Allergic Children

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Parents who have children with food allergies and who blame themselves, vent emotions, seek distractions, and avoid planning for situations in which the food allergy may be a problem are just as likely to have poor quality of life (QoL) as parents who plan too much and become overanxious about their child’s condition.



Dr Rebecca Knibb

“We have two ends of the spectrum causing poorer quality of life. On one end, they are anxious and try to control everything and find it overwhelming,” said Rebecca Knibb, PhD, of Aston University, Birmingham, United Kingdom. On the other end of the spectrum, “we have some who don’t worry at all, they just think, ‘If there’s a reaction, we’ll give an antihistamine.’

“People need to come to the middle ground where they are concerned but not to the point of having anxiety,” Knibb told Medscape.

For example, if parents want to go out to eat at a restaurant, they can look at the restaurant’s menu online to make sure there are foods suitable for the child to eat. “That can help them feel less anxious when they go,” she said.

But if parents overplan by, for example, checking several menus, calling every restaurant, and getting mixed information, “they may get so anxious they feel it’s too much, and it stops them from going, from doing what they want to do.”

Knibb’s research was featured in the opening online oral abstract session at FAAM-EUROBAT Digital this week.

Knibb explained that although there are scales to measure how children and adolescents cope with food allergies, “we really don’t have a scoring system to measure how parents cope.”

By learning how parents manage the stressors of life with food-allergic children, the researchers are hoping to better understand what works and what doesn’t — and develop a toolbox of coping strategies to share with parents.

Parents completed a total of 1149 surveys, 835 from parents of children up to age 17 years who had been diagnosed with food allergy and who were living at home, and 314 from a control group of parents of children who had no chronic health conditions. They were recruited through online media, social media, and survey panels.

The parents who responded were from the United Kingdom, the United States, Australia, New Zealand, and Canada. About 80% of the respondents were women (81.7% in the food-allergic group and 77.5% in the control group).

In the food-allergic group, more than half the children had peanut allergy (54.5%). Other allergies included tree nut (29.7%) milk (42.5%), and egg (35.7%). About one third (35.3%) of the children had experienced an anaphylactic reaction, and more than half (56.5%) had been hospitalized

Parents With Food-Allergic Kids More Likely to Use Active Coping Skills

Parents of children in the food-allergic group overwhelmingly used more “active coping” strategies than in the control group. “We were surprised by this,” Knibb said. Those strategies included planning, acceptance, and engaging instrumental support.

Regarding how coping strategies correlated to QoL, the researchers found that

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health 

50,000 children in Louisiana are without health insurance, the largest increase in a decade | Health care/Hospitals

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Roughly 11,000 children in Louisiana lost their health insurance last year, the largest single-year drop in over a decade and an alarming reversal of years of progress getting kids covered.

About 50,000 children, or 4.4% of children in Louisiana, were uninsured in the state in 2019, according to an analysis of U.S. Census data by the Louisiana Budget Project, compared to 39,000 children who lacked health insurance in 2018. In 2016, the number of uninsured children was even lower, at 36,000.

The data in Louisiana mirror a nationwide trend that experts fear will worsen amid job losses and an unstable economy due to the coronavirus.



What contributes to Louisiana's high maternal mortality rate? The distance to care, research says

22 of Louisiana’s 64 parishes have no hospital offering obstetric care, birth center, OB/GYN or certified nurse-midwives 

“This reflected 2019, which was a year in which we had record low unemployment and a decade of strong economic growth,” said Stacey Roussel, policy director for the Louisiana Budget Project and author of the report. “Still, we were seeing the uninsured rate for children rising across the country as well as here in Louisiana.”

“It also means a record increase in the number of families without insurance for their children as we were going into the largest public health emergency we’ve seen in our generation,” she added.

Access to health care is critical for young brains and bodies, according to researchers and medical experts.

In the first few years of life, over 80% of brain development takes place and the foundation is laid for growth of major body systems.

Interventions are most effective when doctors can spot conditions at a young age before they become a bigger issue.

“Preventative care is the hallmark of pediatric care,” said Dr. Ryan Pasternak, an adolescent medicine specialist and associate professor at LSU Health New Orleans School of Medicine. “Our goal is not only to identify and treat acute and chronic illnesses, but also to address and identify lifelong illnesses.”

Even short gaps in care can allow things to slip through. Pasternak said he saw a young patient this month who lost Medicaid and put off care for seven months. When the patient regained coverage, it was a two and a half hour visit.

“There were just a plethora of issues that had not been addressed,” Pasternak said.

Boy born 22 weeks into mother’s pregnancy

It’s not yet clear exactly why Louisiana’s number of uninsured children has grown so much in a year.

In 2016, Louisiana expanded Medicaid to include those making up to 138% of the federal poverty level, or about $36,000 for a family of four as of 2020. By April 2019, the expansion provided coverage to more than 500,000 additional people.

But in May of last year, Medicaid enrollment dipped after wage checks that automatically kicked off people appearing to make too much money to qualify, dropping by about 50,000 enrollees by the of 2019. But in January, enrollment started to climb again, with 550,000 people covered by the expansion as of Sept. 2020. 

Providers searching

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dentist 

Mobile dentist to provide care for children in Carson City

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The Ronald McDonald Care Mobile will offer oral health care to children and pregnant women at three locations in Carson City next week.
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The Ronald McDonald Care Mobile, in partnership with Nevada Health Centers and Ronald McDonald House Charities, will offer oral health care to children up to age 21 and to pregnant women at three locations in Carson City  Oct. 27-29.

The RMCM offers the same services provided in a brick and mortar dental facility and is staffed with a dentist, dental assistants and office assistants.

COVID precautions will be in place. Preventive dental services will be provided in addition to emergency restorative care. Call 800-787-2568 to schedule an appointment.

Services will be provided at the following times:

  • 7:30 a.m. to 5 p.m. Oct. 27 at Empire Elementary School, 1260 Monte Rosa Drive
  • 7:30 a.m. to 5:30 p.m. Oct. 28 at Empire Elementary School, 1260 Monte Rosa Drive
  • 7:30 a.m. to noon Oct. 29 at McDonald’s, 3095 S. Carson St.

Nevada Health Centers accepts most dental insurance plans, Medicaid and Nevada Check-up.

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health 

Parents can’t be found for 545 children separated by US border policy

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The parents of 545 migrant children who were separated under US border policy cannot be located, a court filing and US rights group revealed Tuesday.

The separations were carried out in relation to US President Donald Trump’s “zero tolerance” policy toward migrants who illegally crossed the border.

“Through our litigation, we just reported to the court that the parents of 545 kids — forcibly separated by the Trump administration’s cruel family separation practice — still cannot be found,” the American Civil Liberties Union tweeted.

Under the zero tolerance program, the US began separating children from their parents in May 2018, prompting a domestic and international outcry.

Then, six weeks into the practice Trump announced that his administration would stop separating families unless the parents posed “a risk” to their child.

Two-thirds of the parents who cannot be found are believed to have been deported, according to a court document posted online by CNN.

According to NBC News, the children whose mothers and fathers have yet to be located were separated under a 2017 pilot program ahead of the zero tolerance policy, and were deported.

“It is critical to find out as much as possible about who was responsible for this horrific practice while not losing sight of the fact that hundreds of families have still not been found and remain separated,” Lee Gelernt, deputy director of the ACLU Immigrants’ Rights Project told NBC.

“There is so much more work to be done to find these families.”

The global coronavirus pandemic briefly hampered a search for the children’s parents, but has now resumed.

“Following a suspension due to the COVID-19 pandemic, limited physical on-the-ground searches for separated parents has now resumed where possible to do so,” the court filing said.

A 2018 court order mandated that the government reunite the separated families.

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medicine 

Sidra Medicine highlights mental health services for children, young people and perinatal women

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Sidra Medicine, has partnered with the Ministry of Public Health (MOPH) in its national mental health and wellness campaign “Are you ok” to highlight the support services available for women, children and young people in Qatar.

Professor. Muhammed Waqar Azeem, the Chair of Psychiatry at Sidra Medicine said, “The pandemic has changed the landscape regarding the critical need for robust mental health support systems.  It is very assuring and speaks to the caliber of the healthcare services in Qatar, to see how the Ministry of Public Health and Sidra Medicine have rapidly mobilized to keep mental health on top of the country’s service agenda. At Sidra Medicine, we remain committed to supporting the people of Qatar, particularly children, young people and perinatal women in meeting their mental health care needs. In addition to world class mental health services, our Department of Psychiatry has started a number of educational and training programs and is also involved in various leading-edge mental health related research projects.”

Sidra Medicine, a QF entity, offers Child and Adolescent Mental Health, Adolescent Medicine and Perinatal Mental Health services in Qatar. The services are either referral based (in the case of children) or self-referral/ direct (perinatal mental health services).

Sidra Medicine’s Child and Adolescent Mental Health Service (CAMHS) is available for children ages five to eighteen (5-18) years and includes outpatient, inpatient, consultation liaison and emergency care.  The service can be accessed via referral from Primary Health Care Centers, private clinics, schools and other sources.

Dr. Ahsan Nazeer, Division Chief of CAHMS at Sidra Medicine said: “As part of our ongoing efforts to strengthen mental health support services, we have focused on patient care, education to build local human resources, research and building community models of care in Qatar.  The success of our program is based on the collaboration of patients, their relatives and our staff, who all work to help achieve patient goals to live their lives as fully possible. I am also proud of our team’s achieving accreditation for the world’s first Child and Adolescent Psychiatry Fellowship from the Accreditation Council for Graduate Medical Education International (ACGMEI).”

“Our advice to parents dealing with children with anxiety, especially during this time, is to encourage their children to share their concerns and have frank and open discussions about their fears and concerns.  It is also important that children obtain accurate information from reliable sources.

We also encourage parents to focus on instilling a sense of hope and optimism in their children by role modelling appropriate positive behaviours,” continued Dr. Nazeer.

Dr. Alanoud Al Ansari, Division Chief of Adolescent Medicine whose clinic provides developmentally appropriate mental health and medical care for adolescents aged 12 to 18 years old, has seen a rise in anxiety in teenagers.

“Teenagers are manifesting their anxiety around loss of control and unpredictability through eating disorders, depression and cutting. Many of them have not been able to cope being back at school. Despite families being in lock down and opting to stay home during the

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