Men with advanced prostate cancer going without life-prolonging medication amid shortage | CNN



CNN
 — 

Doctors across the United States who treat people with advanced prostate cancer can’t find supplies of a medicine that may help them live longer.

Pluvicto, a drug to treat metastatic castration-resistant prostate cancer, also known as mCRPC, is in such short supply that its maker, Novartis, said it cannot allow further supply to new patients until it can produce more of the drug. The company said it is working to produce enough doses to treat existing patients.

“We recognize that this situation is distressing for patients whether they are currently in the treatment process and being rescheduled, or waiting for their first dose of Pluvicto,” Novartis said in a statement to CNN. “Any interruption in the process, from unplanned manufacturing events to doses not arriving in time, may result in patient doses being rescheduled and can have a cascading effect on patients scheduled for future treatment.”

The Swiss company said it has been in touch with treatment centers and providers in the US and is “actively engaging with them to manage rescheduling of patient doses.”

The problem is that Novartis’ manufacturing facility in Ivrea, Italy, can’t keep up with demand for the drug. In May, it had to suspend production at the facility due to what it said was “an abundance of caution” related to potential quality issues. It also paused production at a New Jersey plant that makes the drug for the Canadian market.

Novartis resumed production at both plants in June.

The company hopes to get the New Jersey plant authorized to produce the drug for the US market, but it’s not clear when that might happen. Novartis said in early March that it had completed its filing for approval from the US Food and Drug Administration.

Someone who has a late-stage cancer that has spread to other parts of the body doesn’t have a lot of time to wait for the company to make more, doctors say, nor do they have many other treatment options. So even if Novartis got approval for the New Jersey plant quickly, the help will come too late for many people, according to Dr. Daniel Spratt, chair of the Department of Radiation Oncology at University Hospitals Seidman Cancer Center in Cleveland.

Novartis said it is prioritizing people who are currently being treated with Pluvicto, which is given in six cycles. But Spratt said the supply has recently been too low even for some of these patients.

“Many patients are missing months of therapy,” he said. “The real tragedy is the patients partially under treatment who have had great responses and we can’t get them the rest of their therapy in a timely fashion.”

Next to skin cancer, prostate cancer is the most common cancer in American men, according to the American Cancer Society. Most men do not die from prostate cancer, but about 34,700 people are expected to die from it this year. It’s the second leading cause of cancer death for American men, behind only lung cancer.

Pluvicto is a targeted radioligand therapy, meaning it uses radioactive atoms to deliver radiation to targeted cells, fighting cancer while limiting damage to the surrounding tissues.

There is no cure for this advanced stage of cancer, but Pluvicto can help people live longer. When the drug got FDA approval in March 2022, Spratt said, there was a lot of excitement about its potential. His patients who had heard about the trials have been asking about it for years.

One study from Novartis’ trials found that people who got the drug lived a median of about 15 months after diagnosis, four months longer than the median for people who didn’t get the treatment. For a handful of people, the recovery is even more dramatic.

“There are some patients that really do have those sort of miraculous responses, so it does occasionally give us one of those ‘wow’ moments,” said Dr. William Dahut, chief scientific officer at the American Cancer Society.

Dahut said doctors also like Pluvicto because, compared with other cancer treatments, it’s easy to administer and has relatively few side effects, other than dry mouth.

Another side effect of the shortage is that it’s slowing the progression of research. There is some indication that the drug could help people before their cancer reaches such a late stage.

“We’re anxious to have greater supply to study it in broader populations,” Dahut said.

Spratt said he is working closely with the medical oncologists in his health care system to try to find alternative treatment options, and he’s been looking to get people into clinical trials so they can get access to the therapy.

“But there’s really very few options available,” he said.

Novartis said that if the FDA approves its plant in Milburn, New Jersey, it could supply more Pluvicto as early as this summer.

The agency told CNN that it “is not able to discuss details regarding any possible communications or actions with companies due to commercial confidential information.”

“To be clear, FDA does not manufacture, produce, bottle, or ship drugs and cannot force companies to do so or make more of a drug. However, in general, the FDA works with firms making drugs in shortage to help them ramp up production if they are willing to do so. Often, they need new production lines approved or need new raw material sources approved to help increase supplies. FDA can and does expedite review of these to help resolve shortages of medically necessary drugs.”

Novartis is also building a plant in Indianapolis where the drug will be produced, but that won’t be up and running until the end of the year, the company said.

In the meantime, doctors will often have to tell their patients that they probably won’t be able to help get them this life-extending drug for some time.

“Some men and their physicians will feel that some hope was taken from them,” Spratt siad. “Cancer is the enemy here, not the company, but it’s unfortunate to have that excitement that your physician will be able to prescribe it to you and just not be able to give it to them.”

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100,000 newborn babies will have their genomes sequenced in the UK. It could have big implications for child medicine | CNN



CNN
 — 

The UK is set to begin sequencing the genomes of 100,000 newborn babies later this year. It will be the largest study of its kind, mapping the babies’ complete set of genetic instructions, with potentially profound implications for child medicine.

The £105 million ($126 million) Newborn Genomes Programme will screen for around 200 rare but treatable genetic conditions, with the aim of curtailing untold pain and anxiety for babies and their families, who sometimes struggle to receive a diagnosis through conventional testing. By accelerating the diagnostic process, earlier treatment of infants could prevent many severe conditions from ever developing.

The study would see roughly one in 12 newborn babies in England screened on a voluntary basis over two years. It will operate as an extension of current newborn testing, with the findings intended to inform policymakers, who could pave the way for sequencing to become more commonplace.

Nevertheless, the project has raised many longstanding ethical questions around genetics, consent, data privacy, and priorities within infant healthcare.

In the UK, like many other countries, newborn babies are screened for a number of treatable conditions through a small blood spot sample. Also known as the heel prick test, this method has been routine for over 50 years, and today covers nine conditions including sickle cell disease, cystic fibrosis and inherited metabolic diseases.

“The heel prick is long overdue to be obsolete,” argues Eric Topol, an American cardiologist and professor of molecular medicine at The Scripps Research Institute, who is not connected with the UK sequencing initiative. “It’s very limited and it takes weeks to get the answer. Sometimes, babies that have serious metabolic abnormalities, they’re already being harmed.”

Some conditions that are tested for have variations that may not register a positive result. The consequences can be life-altering.

One example is congenital hyperthyroidism, which impacts neurological development and growth and affects “one in 1,500 to 2,000 babies in the UK,” explains Krishna Chatterjee, professor of endocrinology at the University of Cambridge. It is the result of an absent or under-developed thyroid gland and can be treated with the hormone thyroxine, a cheap and routine medicine. But if treatment doesn’t begin “within the first six months of life, some of those deleterious neurodevelopmental consequences cannot be prevented or reversed.”

The Newborn Genomes Programme will test for one or more forms of congenital hypothyroidism that are not picked up by the heel prick test. “At a stroke, you can make a diagnosis, and that can be game changing – or life changing – for that child,” Chatterjee says.

The program is led by Genomics England, part of the UK Department of Health and Social Care. Along with its partners, it has carried out a variety of preparatory studies, including a large-scale public consultation. A feasibility study is currently underway to assess whether a heel prick, cheek swab or umbilical cord blood will be used for sampling, with the quality of the DNA sample determining the final choice.

Genomics England says that each of the 200 conditions that will be screened for has been selected because there is evidence it is caused by genetic variants; it has a debilitating effect; early or pre-symptomatic treatment has a life-improving impact; and treatment is available for all through the UK’s National Health Service (NHS).

Richard Scott, chief medical officer and deputy CEO at Genomics England, says the program aims to return screening results to families in two weeks, and estimates at least one in 200 babies will receive a diagnosis.

Contracts for sequencing are still to be confirmed, although one contender is American biotech company Illumina. Chief scientist David Bentley says the company has reduced the price of its sequencing 1,000-fold compared to its first genome 15 years ago, and can now sequence the whole human genome for $200.

Bentley argues that early diagnosis via genome sequencing is cost effective in the long term: “People get sick, they get tested using one test after another, and that cost mounts up. (Sequencing) the genome is much cheaper than a diagnostic odyssey.”

Illumina equipment in a sequencing laboratory. The cost of sequencing the human genome has fallen significantly in the last 15 years, says the company.

But while some barriers to genetic screening have fallen, many societal factors are still in play.

Feedback from a public consultation ahead of the UK project’s launch was generally positive, although some participants voiced concerns that religious views could affect uptake, and a few expressed skepticism and mistrust about current scientific developments in healthcare, according to a report on its findings.

Frances Flinter, emeritus professor of clinical genetics and Guy’s and St Thomas’ NHS Foundation Trust and a member of the Nuffield Council on Bioethics, described the program as a “step into the unknown” in a statement to Science Media Centre in December 2022, reacting to the launch of the program.

“We must not race to use this technology before both the science and ethics are ready,” she said at the time. “This research program could provide new and important evidence on both. We just hope the question of whether we should be doing this at all is still open.”

Genome sequencing has raised many philosophical and ethical questions. If you could have aspects of your medical future laid ahead of you, would you want that? What if you were predisposed to an incurable disease? Could that knowledge alone impact your quality of life?

“People don’t generally understand deterministic or fatalistic-type results versus probabilistic, so it does require real teaching of participants,” says Topol. In other words, just because someone has a genetic predisposition to a certain condition, it doesn’t guarantee that they will develop the disease.

Nevertheless, sequencing newborn babies has made some of those questions more acute.

“One of the tenets of genomics and genomics testing is the importance of maintaining people’s autonomy to make their own decisions,” says Scott, highlighting the optional nature of the program.

“We’ve been quite cautious,” he stresses. “All of the conditions that we’re looking for are ones where we think we can make a really substantial impact on those children’s lives.”

Parents-to-be will be invited to participate in the program at their 20-week scan, and confirm their decision after the child’s birth.

“These will be parents, most of whom won’t have any history of a genetic condition, or any reason to worry about one. So it will be an additional challenge for them to appreciate what the value might be for their family,” says Amanda Pichini, clinical lead for genetic counseling at Genomics England.

Part of Pichini’s remit is to ensure equal access to the program and to produce representative data. While diversity comes in many forms, she says – including economic background and rural versus urban location – enlisting ethnically diverse participants is one objective.

“(There) has been a lack of data from other ethnic groups around the world, compared to Caucasians,” says Bentley. “As a result, the diagnostic rates for people from those backgrounds is lower. There are more variants from those backgrounds that we don’t know anything about – we can’t interpret them.”

If genomics is to serve humanity equally, genome data needs to reflect all of it. Data diversity “isn’t an issue that any one country can solve,” says Pichini.

Other countries are also pursuing sequencing programs and reference genomes – a set of genes assembled by scientists to represent a population, for the purpose of comparison. Australia is investing over $500 million AUS (around $333 million) into its genome program; the “All of Us” program is engaged in a five-year mission to sequence 1 million genomes in the US; and in the Middle East, the United Arab Emirates is seeking its own reference genome to investigate genetic diseases disproportionately affecting people in the region, where Illumina’s recently opened Dubai office will add local sequencing capacity.

Richard Scott of Genomics England says he hopes findings from the UK will be useful to other countries’ health systems, especially those not in “a strong position to develop the evidence and to support their decisions as well.”

Sequenced genomes will enter a secure databank using the same model as the National Genomic Research Library, in which they are deidentified and assigned a reference number.

Researchers from the NHS, universities and pharmaceutical companies can apply for access to the National Genomic Research Library (in some cases for a fee), with applications approved by an independent committee that includes participants who have provided samples. There are plenty of restrictions: data cannot be accessed for insurance or marketing purposes, for example.

“We think it’s really important to be transparent about that,” says Pichini. “Often, drugs and diagnostics and therapeutics can’t be developed in the NHS on (its) own. We need to have those partnerships.”

When each child turns 16, they will make their own decision on whether their genomic data should remain in the system. It hasn’t yet been decided if participants can request further investigation of their genome – beyond the scope of newborn screening – at a later date, says Scott.

After the two-year sampling window closes, a cost-benefit analysis of the program will begin, developing evidence for the UK National Screening Committee which advises the government and NHS on screening policies. It’s a process that could take some time.

Chatterjee suggests an entire lifetime might be needed to measure the economic savings that would come from early diagnosis of certain diseases, citing the costs of special needs schooling for children and support for adults living with certain rare genetic conditions: “How does that balance against the technical cost of making a diagnosis and then treatment?”

“I’m quite certain that this cost-benefit equation will balance,” Chatterjee adds.

Multiple interviewees for this article viewed genome sequencing as an extension of current testing, though stopped short of suggesting it could become standard practice for all newborn babies. Even Topol, a staunch advocate for genomics, does not believe it will become universal. “I don’t think you can mandate something like this,” he says. “We’re going to have an anti-genomic community, let’s face it.”

Members of the medical community have expressed a variety of concerns about the program’s approach and scope.

In comments released last December, Angus Clarke, clinical professor at the Institute of Cancer and Genetics at Cardiff University, queried if the program’s whole genome sequencing was driven by a wish to collect more genomic data, rather than improve newborn screening. Louise Fish, chief executive of the Genetic Alliance UK charity, questioned whether following other European nations that are expanding the number of conditions tested through existing bloodspot screening may have “just as great an ability to improve the lives of babies and their families.”

If genome sequencing becomes the norm, it remains to be seen how it will dovetail with precision medicine in the form of gene therapy, including gene editing. While the cost of sequencing a genome has plummeted, some gene therapies can cost millions of dollars per patient.

But for hundreds of babies not yet born in England, diagnosis of rare conditions that have routine treatments will be facilitated by the Newborn Genomes Programme.

“So much of medicine today is given in later life, and saves people for a few months or years,” says Bentley. “It’s so good to see more opportunity here to make a difference through screening and prevention during the early stages of life.

“It is investing maximally in the long-term future as a society, by screening all young people and increasing their chances of survival through genetics so they can realize their enormous potential.”

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Pediatric hospital beds are in high demand for ailing children. Here’s why | CNN



CNN
 — 

Effie Schnacky was wheezy and lethargic instead of being her normal, rambunctious self one February afternoon. When her parents checked her blood oxygen level, it was hovering around 80% – dangerously low for the 7-year-old.

Her mother, Jaimie, rushed Effie, who has asthma, to a local emergency room in Hudson, Wisconsin. She was quickly diagnosed with pneumonia. After a couple of hours on oxygen, steroids and nebulizer treatments with little improvement, a physician told Schnacky that her daughter needed to be transferred to a children’s hospital to receive a higher level of care.

What they didn’t expect was that it would take hours to find a bed for her.

Even though the respiratory surge that overwhelmed doctor’s offices and hospitals last fall is over, some parents like Schnacky are still having trouble getting their children beds in a pediatric hospital or a pediatric unit.

The physical and mental burnout that occurred during the height of the Covid-19 pandemic has not gone away for overworked health care workers. Shortages of doctors and technicians are growing, experts say, but especially in skilled nursing. That, plus a shortage of people to train new nurses and the rising costs of hiring are leaving hospitals with unstaffed pediatric beds.

But a host of reasons building since well before the pandemic are also contributing. Children may be the future, but we aren’t investing in their health care in that way. With Medicaid reimbursing doctors at a lower rate for children, hospitals in tough situations sometimes put adults in those pediatric beds for financial reasons. And since 2019, children with mental health crises are increasingly staying in emergency departments for sometimes weeks to months, filling beds that children with other illnesses may need.

“There might or might not be a bed open right when you need one. I so naively just thought there was plenty,” Schnacky told CNN.

The number of pediatric beds decreasing has been an issue for at least a decade, said Dr. Daniel Rauch, chair of the Committee on Hospital Care for the American Academy of Pediatrics.

By 2018, almost a quarter of children in America had to travel farther for pediatric beds as compared to 2009, according to a 2021 paper in the journal Pediatrics by lead author Dr. Anna Cushing, co-authored by Rauch.

“This was predictable,” said Rauch, who has studied the issue for more than 10 years. “This isn’t shocking to people who’ve been looking at the data of the loss in bed capacity.”

The number of children needing care was shrinking before the Covid-19 pandemic – a credit to improvements in pediatric care. There were about 200,000 fewer pediatric discharges in 2019 than there were in 2017, according to data from the US Department of Health and Human Services.

“In pediatrics, we have been improving the ability we have to take care of kids with chronic conditions, like sickle cell and cystic fibrosis, and we’ve also been preventing previously very common problems like pneumonia and meningitis with vaccination programs,” said Dr. Matthew Davis, the pediatrics department chair at Ann & Robert H. Lurie Children’s Hospital of Chicago.

Pediatrics is also seasonal, with a typical drop in patients in the summer and a sharp uptick in the winter during respiratory virus season. When the pandemic hit, schools and day cares closed, which slowed the transmission of Covid and other infectious diseases in children, Davis said. Less demand meant there was less need for beds. Hospitals overwhelmed with Covid cases in adults switched pediatric beds to beds for grownups.

As Covid-19 tore through Southern California, small hospitals in rural towns like Apple Valley were overwhelmed, with coronavirus patients crammed into hallways, makeshift ICU beds and even the pediatric ward.

Only 37% of hospitals in the US now offer pediatric services, down from 42% about a decade ago, according to the American Hospital Association.

While pediatric hospital beds exist at facilities in Baltimore, the only pediatric emergency department in Baltimore County is Greater Baltimore Medical Center in Towson, Maryland, according to Dr. Theresa Nguyen, the center’s chair of pediatrics. All the others in the county, which has almost 850,000 residents, closed in recent years, she said.

The nearby MedStar Franklin Square Medical Center consolidated its pediatric ER with the main ER in 2018, citing a 40% drop in pediatric ER visits in five years, MedStar Health told CNN affiliate WBAL.

In the six months leading up to Franklin Square’s pediatric ER closing, GBMC admitted an average of 889 pediatric emergency department patients each month. By the next year, that monthly average jumped by 21 additional patients.

“Now we’re seeing the majority of any pediatric ED patients that would normally go to one of the surrounding community hospitals,” Nguyen said.

In July, Tufts Medical Center in Boston converted its 41 pediatric beds to treat adult ICU and medical/surgical patients, citing the need to care for critically ill adults, the health system said.

In other cases, it’s the hospitals that have only 10 or so pediatric beds that started asking the tough questions, Davis said.

“Those hospitals have said, ‘You know what? We have an average of one patient a day or two patients a day. This doesn’t make sense anymore. We can’t sustain that nursing staff with specialized pediatric training for that. We’re going to close it down,’” Davis said.

Registered nurses at Tufts Medical Center hold a

Saint Alphonsus Regional Medical Center in Boise closed its pediatric inpatient unit in July because of financial reasons, the center told CNN affiliate KBOI. That closure means patients are now overwhelming nearby St. Luke’s Children’s Hospital, which is the only children’s hospital in the state of Idaho, administrator for St. Luke’s Children’s Katie Schimmelpfennig told CNN. Idaho ranks last for the number of pediatricians per 100,000 children, according to the American Board of Pediatrics in 2023.

The Saint Alphonsus closure came just months before the fall, when RSV, influenza and a cadre of respiratory viruses caused a surge of pediatric patients needing hospital care, with the season starting earlier than normal.

The changing tide of demand engulfed the already dwindling supply of pediatric beds, leaving fewer beds available for children coming in for all the common reasons, like asthma, pneumonia and other ailments. Additional challenges have made it particularly tough to recover.

Another factor chipping away at bed capacity over time: Caring for children pays less than caring for adults. Lower insurance reimbursement rates mean some hospitals can’t afford to keep these beds – especially when care for adults is in demand.

Medicaid, which provides health care coverage to people with limited income, is a big part of the story, according to Joshua Gottlieb, an associate professor at the University of Chicago Harris School of Public Policy.

“Medicaid is an extremely important payer for pediatrics, and it is the least generous payer,” he said. “Medicaid is responsible for insuring a large share of pediatric patients. And then on top of its low payment rates, it is often very cumbersome to deal with.”

Pediatric gastroenterologist Dr. Howard Baron visits with a patient in 2020 in Las Vegas. A large portion of his patients are on Medicaid with reimbursement rates that are far below private insurers.

Medicaid reimburses children’s hospitals an average of 80% of the cost of the care, including supplemental payments, according to the Children’s Hospital Association, a national organization which represents 220 children’s hospitals. The rate is far below what private insurers reimburse.

More than 41 million children are enrolled in Medicaid and the Children’s Health Insurance Program, according to Kaiser Family Foundation data from October. That’s more than half the children in the US, according to Census data.

At Children’s National Hospital in Washington, DC, about 55% of patients use Medicaid, according to Dr. David Wessel, the hospital’s executive vice president.

“Children’s National is higher Medicaid than most other children’s hospitals, but that’s because there’s no safety net hospital other than Children’s National in this town,” said Wessel, who is also the chief medical officer and physician-in-chief.

And it just costs more to care for a child than an adult, Wessel said. Specialty equipment sized for smaller people is often necessary. And a routine test or exam for an adult is approached differently for a child. An adult can lie still for a CT scan or an MRI, but a child may need to be sedated for the same thing. A child life specialist is often there to explain what’s going on and calm the child.

“There’s a whole cadre of services that come into play, most of which are not reimbursed,” he said. “There’s no child life expert that ever sent a bill for seeing a patient.”

Low insurance reimbursement rates also factor into how hospital administrations make financial decisions.

“When insurance pays more, people build more health care facilities, hire more workers and treat more patients,” Gottlieb said.

“Everyone might be squeezed, but it’s not surprising that pediatric hospitals, which face [a] lower, more difficult payment environment in general, are going to find it especially hard.”

Dr. Benson Hsu is a pediatric critical care provider who has served rural South Dakota for more than 10 years. Rural communities face distinct challenges in health care, something he has seen firsthand.

A lot of rural communities don’t have pediatricians, according to the American Board of Pediatrics. It’s family practice doctors who treat children in their own communities, with the goal of keeping them out of the hospital, Hsu said. Getting hospital care often means traveling outside the community.

Hsu’s patients come from parts of Nebraska, Iowa and Minnesota, as well as across South Dakota, he said. It’s a predominantly rural patient base, which also covers those on Native American reservations.

“These kids are traveling 100, 200 miles within their own state to see a subspecialist,” Hsu said, referring to patients coming to hospitals in Sioux Falls. “If we are transferring them out, which we do, they’re looking at travels of 200 to 400 miles to hit Omaha, Minneapolis, Denver.”

Inpatient pediatric beds in rural areas decreased by 26% between 2008 and 2018, while the number of rural pediatric units decreased by 24% during the same time, according to the 2021 paper in Pediatrics.

Steve Inglish, left, and registered nurse Nikole Hoggarth, middle, help a father with his daughter, who fell and required stiches, inside the emergency department at Jamestown Regional Medical Center in rural North Dakota in 2020.

“It’s bad, and it’s getting worse. Those safety net hospitals are the ones that are most at risk for closure,” Rauch said.

In major cities, the idea is that a critically ill child would get the care they need within an hour, something clinicians call the golden hour, said Hsu, who is the critical care section chair at the American Academy of Pediatrics.

“That golden hour doesn’t exist in the rural population,” he said. “It’s the golden five hours because I have to dispatch a plane to land, to drive, to pick up, stabilize, to drive back, to fly back.”

When his patients come from far away, it uproots the whole family, he said. He described families who camp out at a child’s bedside for weeks at a time. Sometimes they are hundreds of miles from home, unlike when a patient is in their own community and parents can take turns at the hospital.

“I have farmers who miss harvest season and that as you can imagine is devastating,” Hsu said. “These aren’t office workers who are taking their computer with them. … These are individuals who have to live and work in their communities.”

Back at GBMC in Maryland, an adolescent patient with depression, suicidal ideation and an eating disorder was in the pediatric emergency department for 79 days, according to Nguyen. For months, no facility had a pediatric psychiatric bed or said it could take someone who needed that level of care, as the patient had a feeding tube.

“My team of physicians, social workers and nurses spend a significant amount of time every day trying to reach out across the state of Maryland, as well as across the country now to find placements for this adolescent,” Nguyen said before the patient was transferred in mid-March. “I need help.”

Nguyen’s patient is just one of the many examples of children and teens with mental health issues who are staying in emergency rooms and sometimes inpatient beds across the country because they need help, but there isn’t immediately a psychiatric bed or a facility that can care for them.

It’s a problem that began before 2020 and grew worse during the pandemic, when the rate of children coming to emergency rooms with mental health issues soared, studies show.

Now, a nationwide shortage of beds exists for children who need mental health help. A 2020 federal survey revealed that the number of residential treatment facilities for children fell 30% from 2012.

“There are children on average waiting for two weeks for placement, sometimes longer,” Nguyen said of the patients at GBMC. The pediatric emergency department there had an average of 42 behavioral health patients each month from July 2021 through December 2022, up 13.5% from the same period in 2017 to 2018, before the pandemic, according to hospital data.

When there are mental health patients staying in the emergency department, that can back up the beds in other parts of the hospital, creating a downstream effect, Hsu said.

“For example, if a child can’t be transferred from a general pediatric bed to a specialized mental health center, this prevents a pediatric ICU patient from transferring to the general bed, which prevents an [emergency department] from admitting a child to the ICU. Health care is often interconnected in this fashion,” Hsu said.

“If we don’t address the surging pediatric mental health crisis, it will directly impact how we can care for other pediatric illnesses in the community.”

Dr. Susan Wu, right, chats with a child who got her first dose of the Pfizer-BioNtech Covid-19 vaccine at Children's Hospital Arcadia Speciality Care Center in Arcadia, California, in 2022.

So, what can be done to improve access to pediatric care? Much like the reasons behind the difficulties parents and caregivers are experiencing, the solutions are complex:

  • A lot of it comes down to money

Funding for children’s hospitals is already tight, Rauch said, and more money is needed not only to make up for low insurance reimbursement rates but to competitively hire and train new staff and to keep hospitals running.

“People are going to have to decide it’s worth investing in kids,” Rauch said. “We’re going to have to pay so that hospitals don’t lose money on it and we’re going to have to pay to have staff.”

Virtual visits, used in the right situations, could ease some of the problems straining the pediatric system, Rauch said. Extending the reach of providers would prevent transferring a child outside of their community when there isn’t the provider with the right expertise locally.

  • Increased access to children’s mental health services

With the ongoing mental health crisis, there’s more work to be done upstream, said Amy Wimpey Knight, the president of CHA.

“How do we work with our school partners in the community to make sure that we’re not creating this crisis and that we’re heading it off up there?” she said.

There’s also a greater need for services within children’s hospitals, which are seeing an increase in children being admitted with behavioral health needs.

“If you take a look at the reasons why kids are hospitalized, meaning infections, diabetes, seizures and mental health concerns, over the last decade or so, only one of those categories has been increasing – and that is mental health,” Davis said. “At the same time, we haven’t seen an increase in the number of mental health hospital resources dedicated to children and adolescents in a way that meets the increasing need.”

Most experts CNN spoke to agreed: Seek care for your child early.

“Whoever is in your community is doing everything possible to get the care that your child needs,” Hsu said. “Reach out to us. We will figure out a way around the constraints around the system. Our number one concern is taking care of your kids, and we will do everything possible.”

Nguyen from GBMC and Schimmelpfennig from St. Luke’s agreed with contacting your primary care doctor and trying to keep your child out of the emergency room.

“Anything they can do to stay out of the hospital or the emergency room is both financially better for them and better for their family,” Schimmelpfennig said.

Knowing which emergency room or urgent care center is staffed by pediatricians is also imperative, Rauch said. Most children visit a non-pediatric ER due to availability.

“A parent with a child should know where they’re going to take their kid in an emergency. That’s not something you decide when your child has the emergency,” he said.

Jaimie and Effie Schnacky now have an asthma action plan after the 7-year-old's hospitalization in February.

After Effie’s first ambulance ride and hospitalization last month, the Schnacky family received an asthma action plan from the pulmonologist in the ER.

It breaks down the symptoms into green, yellow and red zones with ways Effie can describe how she’s feeling and the next steps for adults. The family added more supplies to their toolkit, like a daily steroid inhaler and a rescue inhaler.

“We have everything an ER can give her, besides for an oxygen tank, at home,” Schnacky said. “The hope is that we are preventing even needing medical care.”

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Senator John Fetterman’s hospitalization for depression has raised awareness of the condition. Our medical analyst explains what it is and how it’s treated | CNN

Editor’s Note: If you or someone you know is struggling with suicidal thoughts or mental health matters, please call the 988 Suicide and Crisis Lifeline, or visit the hotline’s website.



CNN
 — 

Sen. John Fetterman of Pennsylvania is continuing to receive treatment for depression at Walter Reed Medical Center in Bethesda, Maryland, after checking himself into the hospital on February 15. His office has said he has experienced depression “off and on” during his life, but that his condition “only became severe in recent weeks,” necessitating inpatient care.

Fetterman’s disclosure, widely praised by mental health advocates, has prompted many people to ask questions about the often misunderstood illness: What is depression and what are the symptoms? What are its risk factors? How can one distinguish clinical depression from feeling sad? How common is major depressive disorder? What treatments are available and when is hospitalization needed? And how can someone who needs help find assistance?

To guide us through these questions, I spoke with CNN Medical Analyst Dr. Leana Wen, an emergency physician and professor of health policy and management at the George Washington University Milken Institute School of Public Health. She is also chair of the advisory board for Behavioral Health Group, a network of outpatient opioid treatment and recovery centers around the United States. Previously, she served as Baltimore’s health commissioner and chaired the board of Behavioral Health System Baltimore, a nonprofit organization that oversaw mental health services in the city.

CNN: What is depression, and what are its symptoms?

Dr. Leana Wen: Major depressive disorder, colloquially referred to as depression or clinical depression, is a common illness. It is a serious mental health condition characterized by a persistently low or depressed mood and a loss of interest in activities that previously brought a person joy. Other symptoms include a lack of energy, feelings of guilt or worthlessness, an inability to concentrate, appetite changes, sleep disturbances or suicidal thoughts. These symptoms often affect someone’s ability to function at work, at home, and in social interactions.

CNN: How can one distinguish clinical depression from feeling sad? How is a diagnosis made?

Wen: It’s very common to feel down from time to time; many people experience periods of sadness, especially when facing challenging life situations. But this is different from major depressive disorder, for which there are specific diagnostic criteria including depressed mood or lack of interest in normal activities causing social or occupational impairment, and other specified symptoms such as problems with sleep, eating, concentration, energy or self-worth. These symptoms must persist for at least two weeks for a diagnosis of major depressive disorder to be made.

Screening for major depressive disorder generally begins with a physical examination by a health care provider. Often, laboratory tests are done to rule out other ailments, such as hypothyroidism and vitamin deficiency. There are questionnaires that can help screen for depression and aid your physician or other provider with the diagnosis.

CNN: How common is major depressive disorder?

Wen: An estimated 21 million adults in the United States had at least one major depressive disorder episode lasting at least two weeks in 2020, according to the US Substance Abuse and Mental Health Services Administration. This is about 8.4% of all US adults. The prevalence is higher among girls and women compared to boys and men (10.5% compared to 6.2%). The age group with the highest prevalence is young adults 18-25 years old (17%).

The lifetime prevalence of major depressive disorder is even higher; some studies estimate it affects on average 12% of people in the US, but that it could be as high as 17%. That’s 1 in every 6 people.

CNN: What are risk factors for depression?

Wen: There are several different types of risk factors. One is a recent change in life circumstances. The death of a loved one, getting a divorce, losing a home or a job and other major upheavals can increase risk. Other behavioral health conditions, such as anxiety and substance use disorders, are also associated with depression.

A recent illness can increase the risk of major depressive disorder, too. Serious chronic conditions such as heart disease, cancer, multiple sclerosis and dementia are associated with higher rates of depression.

Senator John Fetterman on Capitol Hill in Washington, D.C., on February 14, 2023.

There is a link, too, between stroke and depression; about a third of people who have had a stroke suffer some depressive symptoms.

Senator Fetterman suffered a stroke in May 2022, during his Senate campaign. That could have increased his risk for a depressive episode, especially as, according to his office, he has had episodes of depression in the past.

CNN: What treatments are available, and when is hospitalization needed?

Wen: It’s very important to note that effective treatments are available for major depressive disorder. Initial treatment includes anti-depressant medications and psychotherapy. Sometimes, lifestyle modifications and social supports can also help.

Most patients can be managed effectively with outpatient treatment, meaning that they do not need to be hospitalized. But there are circumstances under which someone may need inpatient treatment in the hospital. A patient could have worsening symptoms and may be suicidal, for instance. They could also have several other medical conditions and may need medication adjustments that are best provided in a hospital setting.

(These refer generally to patients who require hospitalization for major depressive disorder, and not specifically to Senator Fetterman, for whom such detailed medical information is not known and should not be presumed.)

Other individuals can be treated well on an outpatient basis and still from time to time, require inpatient care. This is not dissimilar to how we manage other medical conditions. Patients with diabetes, for example, may be doing well with oral medication then need to switch to insulin. Sometimes, they may have complications that require hospitalization. I think it’s important for us to think about major depressive disorder and other mental health conditions the same as we would physical health conditions.

CNN: How can someone who needs help find assistance?

Wen: For those with a trusted health care provider, a good place to start is to speak with that person. Your physician or other provider can help with the initial assessment, often can make the diagnosis and either begin treatment or refer to someone else who can.

If your primary care provider is delayed in making a referral to a mental health specialist or treating you themselves, you should follow up and emphasize the importance of getting care. Many workplaces and universities offer resources, and there are online telehealth services that could provide some care while you are pursuing referrals through your physician. Local and state health departments often provide some treatment options as well.

In addition, the federal government last year launched the 988 hotline that provides 24/7, free and confidential support for people experiencing emotional distress. The 988 hotline is a network of local and regional hotlines that can refer people and help them get information about where to seek treatment in their area. People can — and should — call or text this number if they are experiencing a mental health crisis.

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Ozempic prescriptions can be easy to get online. Its popularity for weight loss is hurting those who need it most | CNN



CNN
 — 

Telehealth and social media are playing a significant role in driving demand for Ozempic, a prescription drug that treats Type 2 diabetes, experts told CNN. The current drug shortage has limited access for patients with diabetes who rely on it to control their blood sugar.

Digital health companies make medications like Ozempic easier to get by providing prescriptions online. Many advertise quick and easy — sometimes same-day — access.

“Anecdotally, it’s almost easier to get medication [via digital health companies],” said Dr. Disha Narang, endocrinologist and director of obesity medicine at Northwestern Medicine, Lake Forest Hospital. “But not always the safest.” People who put in average weights on the online intake forms were still offered the antidiabetic drug, Narang told CNN.

In part because of Ozempic’s popularity, the prescription weight loss drug market has grown significantly, according to MarketData Enterprises, an independent market research and consulting firm. The market surpassed forecasters’ expectations for 2022 and is expected to become a nearly $2 billion industry in 2023.

WeightWatchers is also tapping into the telehealth prescription drug space. Last week, the company bought telehealth subscription service Sequence, which helps connect patients to doctors who can prescribe weight loss and diabetes drugs.

“At the start of 2022, these companies weren’t marketing this stuff,” Narang said, noting advertising around Ozempic took off in 2022. “I think we really need to start questioning our ethics around this.”

There are few across-the-board requirements when it comes to digital health companies’ intake processes, Dr. Bree Holtz, an associate professor at Michigan State University studying telemedicine, told CNN. Once a patient fills out the required forms online, information gets transferred to an in-state provider who can write the prescription. Some companies require that the patient hop on a video or phone call with the provider — others don’t require either.

“It’s a little scary that you can just wake up and get these appointments in — or these pharmaceuticals — and you’re not being cared for,” said Holtz.

Telehealth has been a game changer in providing access to health care, particularly during the pandemic. And especially for people living in places where high-quality primary care is not available, direct to consumer telehealth services can help fill a gap, said Dr. Laurie Buis, associate professor in the Department of Family Medicine at the University of Michigan, whose research focuses on digital health.

When patients begin to seek selective treatment from selective providers, however, Buis says it opens the door to problems like fragmented care or abuse. Telehealth providers may not have access to a patient’s full medical history and may be less able to provide holistic care that a primary care physician otherwise could.

“I have no doubt that some of these services are doing a good job,” said Buis. “There are also services that don’t take it quite as seriously. And that’s of concern.”

The US Food and Drug Administration first announced that Ozempic was in shortage last August. Supply will likely be strained through mid-March, according to the FDA drug shortages database.

Ozempic prescriptions in the US reached an all-time high in the last week of February, with over 373,000 prescriptions filled, according to a J.P. Morgan analysis of IQVIA data shared with CNN. That’s an increase of 111%, compared with the same week in 2022.

Of these, more than half were new prescriptions, according to a CNN review of J.P. Morgan’s analysis.​​

With many patients relying on Ozempic for diabetes treatment, providers like Narang are scrambling to figure out what alternatives to put their patients on.

“We’re getting messages daily about patients not being able to get their own medication,” Narang said. “It’s been tough for patients and providers alike.”

Ozempic currently holds more than 40% of the US market share of glucagon-like peptide 1 (GLP-1) agonists — a class of drugs that mimic an appetite-regulating hormone — according to analysis from J.P. Morgan. These drugs work by stimulating the release of insulin, which helps lower blood sugar. They also slow the passage of food through the gut.

Ozempic has grown quickly in popularity since it was first put on the market in 2018. The drug has safely and successfully been used to help diabetics improve blood sugar levels and put diabetes into remission, Narang told CNN. Ozempic is the most potent of all the GLP-1 medications, she said.

Behind the brand name Ozempic is the medication semaglutide. While Ozempic is used primarily to treat Type 2 diabetes, another drug by the name Wegovy — also semaglutide — is approved specifically for chronic weight management.

Although approved by the FDA in 2021, Wegovy was not readily available through most of last year, according to Narang, so people turned to Ozempic. According to the FDA drug shortages database, Wegovy was undersupplied starting at the end of last March but came back in stock earlier this year.

Social media buzz around the two drugs took off at the start of 2023. Celebrities shared their testimonies about how semaglutide helped them shed unwanted pounds. Elon Musk, for example, publicly credited Ozempic and Wegovy in part for his weight loss.

#Ozempic and #Wegovy have been “extremely popular” over the last few months on TikTok, according to company analytics.

The use of Ozempic and Wegovy for short-term weight loss has resulted in real consequences for patients who need the drugs most for diabetes treatment and chronic weight management, said Narang. For example, some insurance companies in the past have reportedly refused to cover Wegovy, one calling it a “vanity drug.”

Both drugs are intended for long-term use, not for short-term weight loss. Their appetite-regulating effects wear off quickly after you stop taking them.

“This is not meant to be a medication to take off your last five or 10 pounds to get ready for an event or something like that. It’s not for use of three or four weeks,” Narang said. “When we think about weight management, we’re thinking about the next 25 years of someone’s life.”



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Chronic pain patients struggle to get opioid prescriptions filled, even as CDC eases guidelines | CNN



KHN
 — 

Jessica Layman estimates she has called more than 150 doctors in the past few years in her search for someone to prescribe opioids for her chronic pain.

“A lot of them are straight-up insulting,” said the 40-year-old, who lives in Dallas. “They say things like ‘We don’t treat drug addicts.’”

Layman has tried a host of non-opioid treatments to help with the intense daily pain caused by double scoliosis, a collapsed spinal disc, and facet joint arthritis. But she said nothing worked as well as methadone, an opioid she has taken since 2013.

The latest phone calls came late last year, after her previous doctor shuttered his pain medicine practice, she said. She hopes her current doctor won’t do the same. “If something should happen to him, there’s nowhere for me to go,” she said.

Layman is one of the millions in the U.S. living with chronic pain. Many have struggled to get opioid prescriptions written and filled since 2016 guidelines from the Centers for Disease Control and Prevention inspired laws cracking down on doctor and pharmacy practices. The CDC recently updated those recommendations to try to ease their impact, but doctors, patients, researchers, and advocates say the damage is done.

“We had a massive opioid problem that needed to be rectified,” said Antonio Ciaccia, president of 3 Axis Advisors, a consulting firm that analyzes prescription drug pricing. “But the federal crackdowns and guidelines have created collateral damage: patients left high and dry.”

Born of an effort to fight the nation’s overdose crisis, the guidance led to legal restrictions on doctors’ ability to prescribe painkillers. The recommendations left many patients grappling with the mental and physical health consequences of rapid dose tapering or abruptly stopping medication they’d been taking for years, which carries risks of withdrawal, depression, anxiety, and even suicide.

In November, the agency released new guidelines, encouraging physicians to focus on the individual needs of patients. While the guidelines still say opioids should not be the go-to option for pain, they ease recommendations about dose limits, which were widely viewed as hard rules in the CDC’s 2016 guidance. The new standards also warn doctors about risks associated with rapid dose changes after long-term use.

But some doctors worry the new recommendations will take a long time to make a meaningful change — and may be too little, too late for some patients. The reasons include a lack of coordination from other federal agencies, fear of legal consequences among providers, state policymakers hesitant to tweak laws, and widespread stigma surrounding opioid medication.

The 2016 guidelines for prescribing opioids to people with chronic pain filled a vacuum for state officials searching for solutions to the overdose crisis, said Dr. Pooja Lagisetty, an assistant professor of medicine at the University of Michigan Medical School.

The dozens of laws that states passed limiting how providers prescribe or dispense those medications, she said, had an effect: a decline in opioid prescriptions even as overdoses continued to climb.

The first CDC guidelines “put everybody on notice,” said Dr. Bobby Mukkamala, chair of the American Medical Association’s Substance Use and Pain Care Task Force. Physicians reduced the number of opioid pills they prescribe after surgeries, he said. The 2022 revisions are “a dramatic change,” he said.

The human toll of the opioid crisis is hard to overstate. Opioid overdose deaths have risen steadily in the U.S. in the past two decades, with a spike early in the covid-19 pandemic. The CDC says illicit fentanyl has fueled a recent surge in overdose deaths.

Taking into account the perspective of chronic pain patients, the latest recommendations try to scale back some of the harms to people who had benefited from opioids but were cut off, said Dr. Jeanmarie Perrone, director of the Penn Medicine Center for Addiction Medicine and Policy.

“I hope we just continue to spread caution without spreading too much fear about never using opioids,” said Perrone, who helped craft the CDC’s latest recommendations.

Christopher Jones, director of the CDC’s National Center for Injury Prevention and Control, said the updated recommendations are not a regulatory mandate but only a tool to help doctors “make informed, person-centered decisions related to pain care.”

Multiple studies question whether opioids are the most effective way to treat chronic pain in the long term. But drug tapering is associated with deaths from overdose and suicide, with risk increasing the longer a person had been taking opioids, according to research by Dr. Stefan Kertesz, a professor of medicine at the University of Alabama-Birmingham.

He said the new CDC guidance reflects “an extraordinary amount of input” from chronic pain patients and their doctors but doubts it will have much of an impact if the FDA and the Drug Enforcement Administration don’t change how they enforce federal laws.

The FDA approves new drugs and their reformulations, but the guidance it provides for how to start or wean patients could urge clinicians to do so with caution, Kertesz said. The DEA, which investigates physicians suspected of illegally prescribing opioids, declined to comment.

The DEA’s pursuit of doctors put Danny Elliott of Warner Robins, Georgia, in a horrible predicament, said his brother, Jim.

In 1991, Danny, a pharmaceutical company rep, suffered an electric shock. He took pain medicine for the resulting brain injury for years until his doctor faced federal charges of illegally dispensing prescription opioids, Jim said.

Danny turned to doctors out of state — first in Texas and then in California. But Danny’s latest physician had his license suspended by the DEA last year, and he couldn’t find a new doctor who would prescribe those medications, Jim said.

Danny, 61, and his wife, Gretchen, 59, died by suicide in November. “I’m really frustrated and angry about pain patients being cut off,” Jim said.

Danny became an advocate against forced drug tapering before he died. Chronic pain patients who spoke with KHN pointed to his plight in calling for more access to opioid medications.

Even for people with prescriptions, it’s not always easy to get the drugs they need.

Pharmacy chains and drug wholesalers have settled lawsuits for billions of dollars over their alleged role in the opioid crisis. Some pharmacies have seen their opioid allocations limited or cut off, noted Ciaccia, with 3 Axis Advisors.

Rheba Smith, 61, of Atlanta, said that in December her pharmacy stopped filling her prescriptions for Percocet and MS Contin. She had taken those opioid medications for years to manage chronic pain after her iliac nerve was mistakenly cut during surgery, she said.

Smith said she visited nearly two dozen pharmacies in early January but could not find one that would fill her prescriptions. She finally found a local mail-order pharmacy that filled a one-month supply of Percocet. But now that drug and MS Contin are not available, the pharmacy told her.

“It has been a horrible three months. I have been in terrible pain,” Smith said.

Many patients fear a future of constant pain. Layman thinks about the lengths she’d go to in order to get medication.

“Would you be willing to buy drugs off the street? Would you be willing to go to an addiction clinic and try to get pain treatment there? What are you willing to do to stay alive?” she said. “That is what it comes down to.”

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US maternal death rate rose sharply in 2021, CDC data shows, and experts worry the problem is getting worse | CNN



CNN
 — 

As women continue to die due to pregnancy or childbirth each year in the United States, new federal data shows that the nation’s maternal death rate rose significantly yet again in 2021, with the rates among Black women more than twice as high as those of White women.

Experts said the United States’ ongoing maternal mortality crisis was compounded by Covid-19, which led to a “dramatic” increase in deaths.

The number of women who died of maternal causes in the United States rose to 1,205 in 2021, according to a report from the National Center for Health Statistics, released Thursday by the US Centers for Disease Control and Prevention. That’s a sharp increase from years earlier: 658 in 2018, 754 in 2019 and 861 in 2020.

That means the US maternal death rate for 2021 – the year for which the most recent data is available – was 32.9 deaths per 100,000 live births, compared with rates of 20.1 in 2019 and 23.8 in 2020.

The new report also notes significant racial disparities in the nation’s maternal death rate. In 2021, the rate for Black women was 69.9 deaths per 100,000 live births, which is 2.6 times the rate for White women, at 26.6 per 100,000.

The data showed that rates increased with the mother’s age. In 2021, the maternal death rate was 20.4 deaths per 100,000 live births for women under 25 and 31.3 for those 25 to 39, but it was 138.5 for those 40 and older. That means the rate for women 40 and older was 6.8 times higher than the rate for women under age 25, according to the report.

The maternal death rate in the United States has been steadily climbing over the past three decades, and these increases continued through the Covid-19 pandemic.

Questions remain about how the pandemic may have affected maternal mortality in the United States, according to Dr. Elizabeth Cherot, chief medical and health officer for the infant and maternal health nonprofit March of Dimes, who was not involved in the new report.

“What happened in 2020 and 2021 compared with 2019 is Covid,” Cherot said. “This is sort of my reflection on this time period, Covid-19 and pregnancy. Women were at increased risk for morbidity and mortality from Covid. And that actually has been well-proven in some studies, showing increased risks of death, but also being ventilated in the intensive care unit, preeclampsia and blood clots, all of those things increasing a risk of morbidity and mortality.”

The American College of Obstetricians and Gynecologists previously expressed “great concern” that the pandemic would worsen the US maternal mortality crisis, ACOG President Dr. Iffath Abbasi Hoskins said in a statement Thursday.

“Provisional data released in late 2022 in a U.S. Government Accountability Office report indicated that maternal death rates in 2021 had spiked—in large part due to COVID-19. Still, confirmation of a roughly 40% increase in preventable deaths compared to a year prior is stunning new,” Hoskins said.

“The new data from the NCHS also show a nearly 60% percent increase in maternal mortality rates in 2021 from 2019, just before the start of the pandemic. The COVID-19 pandemic had a dramatic and tragic effect on maternal death rates, but we cannot let that fact obscure that there was—and still is—already a maternal mortality crisis to compound.”

Health officials stress that people who are pregnant should get vaccinated against Covid-19 and that doing so offers protection for both the mother and the baby.

During the early days of the pandemic, in 2020, there was limited information about the vaccine’s risks and benefits during pregnancy, prompting some women to hold off on getting vaccinated. But now, there is mounting evidence of the importance of getting vaccinated for protection against serious illness and the risks of Covid-19 during pregnancy.

The Covid-19 pandemic also may have exacerbated existing racial disparities in the maternal death rate among Black women compared with White women, said Dr. Chasity Jennings-Nuñez, a California-based site director with Ob Hospitalist Group and chair of the perinatal/gynecology department at Adventist Health-Glendale, who was not involved in the new report.

“In terms of maternal mortality, it continues to highlight those structural and systemic problems that we saw so clearly during the Covid-19 pandemic,” Jennings-Nuñez said.

“So in terms of issues of racial health inequities, of structural racism and bias, of access to health care, all of those factors that we know have played a role in terms of maternal mortality in the past continue to play a role in maternal mortality,” she said. “Until we begin to address those issues, even without a pandemic, we’re going to continue to see numbers go in the wrong direction.”

Some policies have been introduced to tackle the United States’ maternal health crisis, including the Black Maternal “Momnibus” Act of 2021, a sweeping bipartisan package of bills that aim to provide pre- and post-natal support for Black mothers, including extending eligibility for certain benefits postpartum.

As part of the Momnibus, President Biden signed the bipartisan Protecting Moms Who Served Act in 2021, and other provisions have passed in the House.

In the United States, about 6.9 million women have little or no access to maternal health care, according to March of Dimes, which has been advocating in support of the Momnibus.

The US has the highest maternal death rate of any developed nation, according to the Commonwealth Fund and the latest data from the World Health Organization. While maternal death rates have been either stable or rising across the United States, they are declining in most countries.

“A high rate of cesarean sections, inadequate prenatal care, and elevated rates of chronic illnesses like obesity, diabetes, and heart disease may be factors contributing to the high U.S. maternal mortality rate. Many maternal deaths result from missed or delayed opportunities for treatment,” researchers from the Commonwealth Fund wrote in a report last year.

The ongoing rise in maternal deaths in the United States is “disappointing,” said Dr. Elizabeth Langen, a high-risk maternal-fetal medicine physician at the University of Michigan Health Von Voigtlander Women’s Hospital. She was not involved in the latest report but cares for people who have had serious complications during pregnancy or childbirth.

“Those of us who work in the maternity care space have known that this is a problem in our country for quite a long time. And each time the new statistics come out, we’re hopeful that some of the efforts that have been going on are going to shift the direction of this trend. It’s really disappointing to see that the trend is not going in the right direction but, at some level, is going in the worst direction and at a little bit of a faster rate,” Langen said.

“In the health care system, we need to accept ultimate responsibility for the women who die in our care,” she added. “But as a nation, we also need to accept some responsibility. We need to think about: How do we provide appropriate maternity care for people? How do we let people have time off of work to see their midwife or physician so that they get the care that they need? How do all of us make it possible to live a healthy life while you’re pregnant so that you have the opportunity to have the best possible outcome?”

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How to reduce PFAS in your drinking water, according to experts | CNN

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CNN
 — 

In the next three years, drinking water in the United States may be a bit safer from potentially toxic chemicals that have been detected in the blood of 98% of Americans.

Perfluoroalkyl and polyfluoroalkyl substances or PFAS are a family of thousands of man-made chemicals that do not break down easily in the environment. A number of PFAS have been linked to serious health problems, including cancer, fertility issues, high cholesterol, hormone disruption, liver damage, obesity and thyroid disease.

The US Environmental Protection Agency proposed on Tuesday stringent new limits on levels of six PFAS chemicals in public water systems. Under the proposed rule, public systems that provide water to at least 15 service connections or 25 people will have three years to implement testing procedures, begin notifying the public about PFAS levels, and reduce levels if above the new standard, the EPA said.

Two of the most well-studied and potentially toxic chemicals, PFOA and PFOS, cannot exceed 4 parts per trillion in drinking water, compared with a previous health advisory of 70 parts per trillion, the EPA said.

Another four chemicals — PFNA, PFHxS, PFBS and GenX — will be subject to a hazard index calculation to determine whether the levels of these PFAS pose a potential risk. The calculation is “a tool the EPA uses to address the cumulative risks from all four of those chemicals,” said Melanie Benesh, vice president of government affairs for the Environmental Working Group, a consumer organization that monitors exposure to PFAS and other chemicals.

“The EPA action is a really important and historic step forward,” Benesh said. “While the proposed regulations only address a few PFAS, they are important marker chemicals. I think requiring water systems to test and treat for these six will actually do a lot to address other PFAS that are in the water as well.”

For people who are concerned about PFAS exposure, three years or so is a long time. What can consumers do now to limit the levels of PFAS in their drinking water?

First, look up levels of PFAS in your local public water system, suggested David Andrews, a senior scientist at the Environmental Working Group. The advocacy nonprofit has created a national tap water database searchable by zip code that lists PFAS and other concerning chemicals, as well as a national map that illustrates where PFAS has been detected in the US.

However, not all water utilities currently test for pollutants, and many rural residents rely on wells for water. Anyone who wants to personally test their water can purchase a test online or from a certified lab, Andrews said.

“The most important thing is to ensure the testing method can detect down to at least four parts per trillion or lower of PFAS,” he said. “There are a large number of labs across the country certified to test to that level, so there are a lot of options available.”

If levels are concerning, consumers can purchase a water filter for their tap. NSF, formerly the National Sanitation Foundation, has a list of recommended filters.

“The water filters that are most effective for PFAS are reverse osmosis filters, which are more expensive, about in the $200 range,” Andrews said. Reverse osmosis filters can remove a wide range of contaminants, including dissolved solids, by forcing water through various filters.

“Granular activated carbon filters are more common and less expensive but not quite as effective or consistent for PFAS,” he said, “although they too can remove a large number of other contaminants.”

Reverse osmosis systems use both carbon-based filters and reverse osmosis membranes, Andrews explained. Water passes through the carbon filter before entering the membrane.

“The important part is that you have to keep changing those filters,” he said. “If you don’t change that filter, and it becomes saturated, the levels of PFAS in the filtered water can actually be above the levels in the tap water.”

Carbon filters are typically replaced every six months, “while the reverse osmosis filter is replaced on a five-year time frame,” he added. “The cost is relatively comparable over their lifetime.”

Another positive: Many of the filters that work for PFAS also filter other contaminants in water, Andrews said.

Drinking water is not the only way PFAS enters the bloodstream. Thousands of varieties of PFAS are used in many of the products we purchase, including nonstick cookware, infection-resistant surgical gowns and drapes, mobile phones, semiconductors, commercial aircraft, and low-emissions vehicles.

The chemicals are also used to make carpeting, clothing, furniture, and food packaging resistant to stains, water and grease damage. Once treated, the report said, textiles emit PFAS over the course of their lifetimes, escaping into the air and groundwater in homes and communities.

Made from a chain of linked carbon and fluorine atoms that do not readily degrade in the environment, PFAS are known as “forever chemicals.” Due to their long half life in the human body, it can take some PFAS years to completely leave the body, according to a 2022 report by the prestigious National Academies of Sciences, Engineering, and Medicine.

“Some of these chemicals have half-lives in the range of five years,” National Academies committee member Jane Hoppin, an environmental epidemiologist and director of the Center for Human Health and the Environment at North Carolina State University in Raleigh, told CNN previously.

“Let’s say you have 10 nanograms of PFAS in your body right now. Even with no additional exposure, five years from now you would still have 5 nanograms.

“Five years later, you would have 2.5 and then five years after that, you’d have one 1.25 nanograms,” she continued. “It would be about 25 years before all the PFAS leave your body.”

The 2022 National Academies report set “nanogram” levels of concern and encouraged clinicians to conduct blood tests on patients who are worried about exposure or who are at high risk. (A nanogram is equivalent to one-billionth of a gram.)

People in “vulnerable life stages” — such as during fetal development in pregnancy, early childhood and old age — are at high risk, the report said. So are firefighters, workers in fluorochemical manufacturing plants, and those who live near commercial airports, military bases, landfills, incinerators, wastewater treatment plants and farms where contaminated sewage sludge is used.

The PFAS-REACH (Research, Education, and Action for Community Health) project, funded by the National Institute of Environmental Health Sciences, gives the following advice on how to avoid PFAS at home and in products:

  • Stay away from stain-resistant carpets and upholstery, and don’t use waterproofing sprays.
  • Look for the ingredient polytetrafluoroethylene, or PTFE, or other “fluoro” ingredients on product labels.
  • Avoid nonstick cookware. Instead use cast-iron, stainless steel, glass or enamel products.
  • Boycott takeout containers and other food packaging. Instead cook at home and eat more fresh foods.
  • Don’t eat microwave popcorn or greasy foods wrapped in paper.
  • Choose uncoated nylon or silk dental floss or one that is coated in natural wax.

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‘Am I dreaming?’: Double lung transplants save two people with late-stage cancer | CNN



CNN
 — 

Two people with stage IV lung cancer who had been told that they had only weeks or months to live are breathing freely after receiving double lung transplants, Northwestern Medicine in Chicago said Wednesday.

Lung cancer is the leading cause of cancer-related deaths in the United States. The American Cancer Society estimates that over 127,000 Americans will die from the disease this year.

It is considered stage IV once additional tumors have developed in the lungs, aside from the primary tumor, or the cancer has spread to more organs.

Someone diagnosed with stage IV lung cancer has limited treatment options, Northwestern Medicine says. A double lung transplantation offers a potentially lifesaving option for some people with a poor prognosis, but doctors say there are specific criteria a lung cancer patient must meet, including that the cancer is contained within the lungs and the person has tried all other treatment options.

In 2020, 54-year-old Albert Khoury of Chicago received a devastating lung cancer diagnosis.

Khoury, a cement finisher for the Chicago Department of Transportation, began to have back pain, sneezing and chills, along with coughing up blood, according to Northwestern Medicine. It was near the start of the Covid-19 pandemic, so at first, he thought he had coronavirus-related symptoms.

He was diagnosed with stage I lung cancer soon after.

Because of the pandemic, Khoury did not begin treatment until July 2020. At that point, the cancer had progressed to stage II and was continuing to grow, eventually reaching stage IV. He was told to consider hospice, special care for people near the end of their lives that focuses on comfort and support.

“I had a couple weeks to live,” Khoury said in a video released by the hospital. “Not that much time.”

His sister suggested that he reach out to Northwestern Medicine about the possibility of a double lung transplant.

“I need new lungs. That is the only hope to live,” Khoury said he told his doctor.

He met with an oncologist at Northwestern Medicine, who told him he should try additional treatments first. But not too long after, he was admitted to the intensive care unit with pneumonia and sepsis.

As his health declined, the oncologists began considering the rarely used procedure.

“His lungs were filled with cancer cells, and day by day, his oxygen was dropping,” said Dr. Young Chae, a medical oncologist at Northwestern Medicine who helped treat Khoury.

Transplant is typically considered for people with some form of lung cancer that has not spread to other parts of the body and for those who have tried all other treatment options and have limited time to live, according to Dr. Ankit Bharat, chief of thoracic surgery at the Northwestern Medicine Canning Thoracic Institute, who helped treat Khoury.

William Dahut, chief scientific officer at the American Cancer Society, also noted the importance of ensuring that cancer has not spread to other parts of the body before doing a transplant.

“There would need to be as much certainty as possible that the cancer is limited to the lungs, so whatever sort of extensive screening tests should be done … to ensure that there are no cancer cells outside of the lungs,” said Dahut, who was not involved in the care of either Northwestern patient.

The oncologists decided Khoury was eligible for the procedure. In September 2021, he spent about seven hours in surgery.

“Surgeons had to be extremely meticulous to not let trillions of cancer cells from the old lungs spill out into Khoury’s chest cavity or into his blood stream,” Northwestern Medicine noted in a news release.

The surgery is not without risk, Bharat said. In people with late-stage cancers, there is always a chance of it returning after the procedure.

“There is certainly the risk of potentially being in a worse off situation than they were,” he said. “So you go through a big surgery, and then you could very quickly have the cancer come back.”

Another risk is the treatment needed after a transplant, Dahut said.

All lung transplant recipients have to take medications to weaken their immune systems, which helps reduce the possibility of their body rejecting the organ – but also decreases its ability to fight off infection, according to the National Cancer Institute.

“Drugs that actually suppress your immune system put you at risk for infection afterwards but could even potentially put you at risk for second cancers afterwards,” Dahut said.

However, 18 months later, Khoury has not had any complications and is back to work.

His doctor showed him an X-ray of his chest with no signs of cancer. “When I saw that X-ray, I believed him,” Khoury said. “My body is in my hands now.”

The procedure was put to the test again last year, this time in a 64-year-old Minnesota woman.

Tannaz Ameli, a retired nurse from Minneapolis, had a persistent cough for several months. Her doctors did a chest X-ray and diagnosed her with pneumonia.

The illness lingered until she was told she had stage IV lung cancer in January 2022.

“There was no hope for my life at that point. They gave me … three months,” Ameli said in a video released by Northwestern Medicine.

She went through unsuccessful chemotherapy treatments and was told to consider hospice.

“I had no hope. I was ready for my life to end,” she said.

But her husband reached out to Northwestern Medicine about the option of a transplant. The oncologists found that Ameli fit their criteria, and she received a double lung transplant in July.

When she was told the procedure had made her cancer-free, she wondered, ” ‘Am I dreaming, sitting here? Can it happen?’ And it did happen.”

Ameli hasn’t had any complications, and she said the procedure has given her a new perspective on life.

“Every morning when I open my eyes, I just can’t believe it,” Ameli said. “Life has a different meaning now.”

Double lung transplants for cancer are rare due to the concern that the cancer may come back, Bharat said.

Historically, the surgery required sequential transplantations, but they are looking to alter the approach to lower the risk of recurrence, he said.

“Typically, what happens in a double lung transplant procedure is, we take one lung out, put the new one in, then take the second lung out and put the second lung in,” he said. “The concern is that when you take one lung out and put a new lung, the other lung is still attached, and they could cross-contaminate. … You could inadvertently have the cancer cells spread into the bloodstream.”

If cancer cells cross-contaminate or enter the bloodstream, there is a higher risk of cancer coming back.

Bharat and his team took a different approach with Khoury and Ameli: They opened the chest cavity and did a full heart and lung bypass.

“Essentially, what that means is, we don’t let any blood go through the heart and the lungs and bypass all of that,” Bharat said. “That allows us to then stop the blood flow to the lungs, which will prevent any cancer cells from going from the lung into the bloodstream.”

The surgeons gave Khoury and Ameli lung-shaped friendship necklaces Wednesday to mark their success.

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Most men with prostate cancer can avoid or delay harsh treatments, long-term study confirms | CNN



CNN
 — 

Most men who are diagnosed with prostate cancer can delay or avoid harsh treatments without harming their chances of survival, according to new results from a long-running study in the United Kingdom.

Men in the study who partnered with their doctors to keep a close eye on their low- to intermediate-risk prostate tumors – a strategy called surveillance or active monitoring – slashed their risk of the life-altering complications such as incontinence and erectile dysfunction that can follow aggressive treatment for the disease, but they were no more likely to die of their cancers than men who had surgery to remove their prostate or who were treated with hormone blockers and radiation.

“The good news is that if you’re diagnosed with prostate cancer, don’t panic, and take your time to make a decision” about how to proceed, said lead study author Dr. Freddie Hamdy, professor of surgery and urology at the University of Oxford.

Other experts who were not involved in the research agreed that the study was reassuring for men who are diagnosed with prostate cancer and their doctors.

“When men are carefully evaluated and their risk assessed, you can delay or avoid treatment without missing the chance to cure in a large fraction of patients,” said Dr. Bruce Trock, a professor of urology, epidemiology and oncology at Johns Hopkins University.

The findings do not apply to men who have prostate cancers that are scored through testing to be high-risk and high-grade. These aggressive cancers, which account for about 15% of all prostate cancer diagnoses, still need prompt treatment, Hamdy said.

For others, however, the study adds to a growing body of evidence showing that surveillance of prostate cancers is often the right thing to do.

“What I take away from this is the safety of doing active monitoring in patients,” said Dr. Samuel Haywood, a urologic oncologist at the Cleveland Clinic in Ohio, who reviewed the study, but was not involved in the research.

Results from the study were presented on Saturday at the European Association of Urology annual conference in Milan, Italy. Two studies on the data were also published in the New England Journal of Medicine and a companion journal, NEJM Evidence.

Prostate cancer is the second most common cancer in men in the United States, behind non-melanoma skin cancers. About 11% – or 1 in 9 – American men will be diagnosed with prostate cancer in their lifetime, and overall, about 2.5% – or 1 in 41 – will die from it, according to the National Cancer Institute. About $10 billion is spent treating prostate cancer in the US each year.

Most prostate cancers grow very slowly. It typically takes at least 10 years for a tumor confined to the prostate to cause significant symptoms.

The study, which has been running for more than two decades, confirms what many doctors and researchers have come to realize in the interim: The majority of prostate cancers picked up by blood tests that measure levels of a protein called prostate-specific antigen, or PSA, will not harm men during their lifetimes and don’t require treatment.

Dr. Oliver Sartor, medical director of the Tulane Cancer Center, said men should understand that a lot has changed over time, and doctors have refined their approach to diagnosis since the study began in 1999.

“I wanted to make clear that the way these patients are screened and biopsied and randomized is very, very different than how these same patients might be screened, biopsied and randomized today,” said Sartor, who wrote an editorial on the study but was not involved in the research.

He says the men included in the study were in the earliest stages of their cancer and were mostly low-risk.

Now, he says, doctors have more tools, including MRI imaging and genetic tests that can help guide treatment and minimize overdiagnosis.

The study authors say that to assuage concerns that their results might not be relevant to people today, they re-evaluated their patients using modern methods for grading prostate cancers. By those standards, about one-third of their patients would have intermediate or high-risk disease, something that didn’t change the conclusions.

When the study began in 1999, routine PSA screening for men was the norm. Many doctors encouraged annual PSA tests for their male patients over age 50.

PSA tests are sensitive but not specific. Cancer can raise PSA levels, but so can things like infections, sexual activity and even riding a bicycle. Elevated PSA tests require more evaluation, which can include imaging and biopsies to determine the cause. Most of the time, all that followup just isn’t worth it.

“It is generally thought that only about 30% of the individuals with an elevated PSA will actually have cancer, and of those that do have cancer, the majority don’t need to be treated,” Sartor said.

Over the years, studies and modeling have shown that using regular PSA tests to screen for prostate cancer can do more harm than good.

By some estimates, as many as 84% of men with prostate cancer identified through routine screening do not benefit from having their cancers detected because their cancer would not be fatal before they died of other causes.

Other studies have estimated about 1 to 2 in every five men diagnosed with prostate cancer is overtreated. The harms of overtreatment for prostate cancer are well-documented and include incontinence, erectile dysfunction and loss of sexual potency, as well as anxiety and depression.

In 2012, the influential US Preventive Services Task Force advised healthy men not to get PSA tests as part of their regular checkups, saying the harms of screening outweighed its benefits.

Now, the task force opts for a more individualized approach, saying men between the ages of 55 and 69 should make the decision to undergo periodic PSA testing after carefully weighing the risks and benefits with their doctor. They recommend against PSA-based screening for men over the age of 70.

The American Cancer Society endorses much the same approach, recommending that men at average risk have a conversation with their doctor about the risks and benefits beginning at age 50.

The trial has been following more than 1,600 men who were diagnosed with prostate cancer in the UK between 1999 and 2009. All the men had cancers that had not metastasized, or spread to other parts of their bodies.

When they joined, the men were randomly assigned to one of three groups: active monitoring or using regular blood tests to keep an eye on their PSA levels; radiotherapy, which used hormone-blockers and radiation to shrink tumors; and prostatectomy, or surgery to remove the prostate.

Men who were assigned monitoring could change groups during the study if their cancers progressed to the point that they needed more aggressive treatment.

Most of the men have been followed for around 15 years now, and for the most recent data analysis, researchers were able get follow-up information on 98% of the participants.

By 2020, 45 men – about 3% of the participants – had died of prostate cancer. There were no significant differences in prostate cancer deaths between the three groups.

Men in the active monitoring group were more likely to have their cancer progress and more likely to have it spread compared with the other groups. About 9% of men in the active monitoring group saw their cancer metastasize, compared with 5% in the two other groups.

Trock points out that even though it didn’t affect their overall survival, a spreading cancer isn’t an insignificant outcome. It can be painful and may require aggressive treatments to manage at that stage.

Active surveillance did have important benefits over surgery or radiation.

As they followed the men over 12 years, the researchers found that 1 in 4 to 1 in 5 of those who had prostate surgery needed to wear at least one pad a day to guard against urine leaks. That rate was twice as high as the other groups, said Dr. Jenny Donovan of the University of Bristol, who led the study on patient-reported outcomes after treatment.

Sexual function was affected, too. It’s natural for sexual function to decline in men with age, so by the end of the study, nearly all the men reported low sexual function, but their patterns of decline were different depending on their prostate cancer treatment, she said.

“The men who have surgery have low sexual function early on, and that continues. The men in the radiotherapy group see their sexual function drop, then have some recovery, but then their sexual function declines, and the active monitoring group declines slowly over time,” Donovan said.

Donovan said that when she presents her data to doctors, they point out how much has changed since the study started.

“Some people would say, ‘OK, yeah, but we’ve got all these new technologies now, new treatments,’ ” she said, such as intensity-modulated radiation therapy, brachytherapy and robot-assisted prostate surgeries, “but actually, other studies have shown that the effects on these functional outcomes are very similar to the effects that we see our study,” she said.

Both Donovan and Hamby feel the study’s conclusions still merit careful consideration by men and their doctors as they weigh treatment decisions.

“What we hope that clinicians will do is use these figures that we’ve produced in these papers and share them with the men so that newly diagnosed men with localized prostate cancer can really assess those tradeoffs,” Donovan said.

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