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Tuesday, September 6, 2022

60 Minutes: Rising rates of suicide, depression accelerated by pandemic among U.S. kids

 The U.S. surgeon general has called it an 'urgent public health crisis' – a devastating decline in the mental health of kids across the country. According to the CDC, the rates of suicide, self-harm, anxiety and depression are up among adolescents – a trend that began before the pandemic.

Tonight, we'll take you to Milwaukee, Wisconsin, a community trying to help its kids navigate a mental health crisis. As we first reported in May, Wisconsin has the fifth highest increase of adolescent self-harm and attempted suicide 

In the country, with rates nearly doubling since before the pandemic.

In the emergency room at Children's Hospital in Milwaukee, doctors like Michelle Pickett are seeing more kids desperate for mental health help.

Dr. Michelle Pickett: We unfortunately see a lotta kids who have attempted suicide. That is something that we see I'd say at least once a shift.

Sharyn Alfonsi: Once a shift?

Dr. Michelle Pickett: Oh-- yes. Yes, Unfortunately.

Dr. Pickett has worked in the ER for 9 years.

Sharyn Alfonsi: Is there any group that's not being impacted? 

Dr. Michelle Pickett: No. We're seeing it all; kids, you know, who come from very well-off families; kids who don't; kids who are suburban; kids who are urban; kids who are rural. We're-- we're seein' it all.

The surge of families needing help for their kids has revealed a deficit of people and places to treat them.

Across the country, the average wait time to get an appointment with a therapist is 48 days – and for children it's often longer.

Sharyn Alfonsi: What does it say to you that the place they have to come to is the emergency room?

Dr. Michelle Pickett: That there's something wrong with our system. The emergency room should not be the place to go and get, you know, acute mental health care when you're in a crisis. We are not a nice, calm environment. 

Sharyn Alfonsi: But they're desperate–

Dr. Michelle Pickett: Yeah, we're there and we see everybody. But I wish there were more places that kids could go to get the help that they need.

To manage the mental health crisis and heavy caseload, Dr. Pickett introduced an iPad with a series of questions that screen the mental health of every child ten and older who comes to the ER for any reason.

Among the questions: "have you been having thoughts about killing yourself," and "have you felt your family would be better off if you were dead."

Harsh questions that can be lifesavers to the kids who answer them.

Dr. Michelle Pickett: We've had four kids that I know of personally that came in for a completely unrelated problem so, a broken arm or an earache or whatever it was and actually were acutely suicidal to the point where we needed to transfer them to inpatient-- facility right then and there. So, we're catchin' kids, you know, who are in very much crisis like that. But we're also catchin' the kids that just need help and don't know what to do, and haven't really talked about this.

According to the CDC, hospital admissions data shows the number of teenage girls who have been suicidal has increased 50% nationwide since 2019. Sophia Jimenez was one of them.

Sophia Jimenez: I remember crying every night and not knowing what was going on and I felt so alone.

Sophia and her friend, Neenah Hughes, were in eighth grade, looking forward to high school when COVID turned their worlds upside down.

Neenah Hughes: I've always been a super smart kid, and I've always had really good grades. And then as soon as the pandemic hit, I failed a class. When I was virtual I had no motivation to do anything.  I would just sit in my room, never leave, and it was, like, obvious signs of depression. 

Sophia Jimenez: My mental health got really bad, especially my-- eating disorder. I was basically home alone all day. My parents-- well, they noticed that I wasn't eating. I would refuse to eat. So then they ended up taking me to the hospital.

Sophia had to stay in the hospital for two weeks before a bed opened up at a psychiatric facility.

Sharyn Alfonsi: Your generation, like, got hit with this in what's supposed be kind of a fun, carefree time. What was lost? What did you guys lose during the pandemic?

Sophia Jimenez: Myself.

Sharyn Alfonsi: Yourself.

Neenah Hughes: Yeah. I would definitely say there were big pieces of myself that I-- were definitely lost. I lost friends because we wouldn't see each other. we couldn't go to our first Homecoming, I couldn't have an eighth grade graduation. I know that doesn't sound like that big of a deal, but we were looking forward....

Sharyn Alfonsi: But it is a big deal when you're in eighth grade.  

Neenah Hughes: Yeah. I feel like if the pandemic hadn't happened at all, a lot of my, like, sadness and mental problems would not be as bad as they are. It just made everything worse. 

Sharyn Alfonsi: Are we in crisis mode right now?

Tammy Makhlouf: We are. We are in crisis mode. And it's scary.

Tammy Makhlouf has worked as a child therapist throughout Wisconsin for the last 25 years.  

Sharyn Alfonsi: I think there was a hope that, you know, we're back in school, the kids are able to see their friends again, and play sports, that this would all go away. Has it?

Tammy Makhlouf: No. No. I've noticed that the wait lists are longer, kids are struggling with more anxiety, more depression. So we were in a mental health crisis prior to the pandemic.

Sharyn Alfonsi: Did the pandemic accelerate it?

Tammy Makhlouf: I believe so. We're coming out of the pandemic, but kids have still lost two years. Two years of socialization, two years of education, two years of their world kinda being shaken up. So as we get quote-unquote, 'back to normal,' I think kids are struggling. Even when the pandemic is over, this crisis isn't going to be over.

CDC numbers show that even before the pandemic, the number of adolescents saying they felt persistently sad or hopeless was up 40% since 2009.

There are lots of theories on why – social media, increased screen time and isolation, but the research isn't definitive.

This past March, Tammy Makhlouf was tapped by Children's Hospital to run an urgent care walk-in clinic specifically opened to treat kid's mental health.

Open seven days a week from 3 to 9:30, it is one of the first clinics of its kind in the country.

Tammy Makhlouf: So when they come to our clinic, we assess them, and we provide them with a therapy session. So we give them some interventions.We give them a plan, an action plan.  

The plans are catered to each child's situation. Actionable things families and kids can do while they look for a doctor or facility to make room for them.

Sharyn Alfonsi: How long have the wait lists been to get help?

Tammy Makhlouf: Normally you're put on you're scheduled an appointment within a few months.

Sharyn Alfonsi: Months?

Tammy Makhlouf: Yeah. And then if you want a child psychiatrist you're looking at months to a year.

Sharyn Alfonsi: How important is it to get them help when they need it, immediately?

Tammy Makhlouf: As days go on, the symptoms get worse. If you have a depressed child, you know, maybe they started out where they were feeling depressed, and then as the days goes on, they're suicidal. So it really-- you really do need to get that help and that support right away.

Eleven-year-old Austin Bruenger desperately needed that support during the pandemic. He's a fifth grader at Roosevelt Elementary School in Milwaukee.

Sharyn Alfonsi: how old were you when the pandemic hit? 

Austin Bruenger: I was nine. I was still going to school, but then I kept hearing on the news in the car, just like, pandemic, stay put, quarantine, 14 days.

Sharyn Alfonsi: When they first said, "Hey, you don't have to go to school," what was your reaction at that moment?

Austin Bruenger: Heaven. But then I realized it's the complete opposite.

Opposite because like millions of school age kids, Austin was forced into remote learning for more than a year and disconnected from friends.

Austin Bruenger: I was like this shut in. The only way you could see people is through like, phones or your family that you live with.

That isolation took a toll on Austin who was already struggling with news that his parents were getting a divorce.

Melissa Bruenger: And that's when I think everything just started to magnify. He, you know, he was always asking to see his friends. We couldn't. And I remember there was one moment that he was just on the floor, like, kicking and punching the air. Just-- but couldn't describe why he was upset. 

Unable to vent with friends, and without access to in-person therapy, Austin's mother Melissa says his world began closing in on him.

Melissa Bruenger: It felt like he was interacting less and just kinda withdrawing into himself and spending a lotta time by himself. And I went to go tuck him in and he said, "Mom, I'm having suicidal thoughts."

Sharyn Alfonsi: And he was how old?

Melissa Bruenger: He was nine. And, like, I was kinda like, I-- I didn't know what to say. I didn't know what to do.

Austin Bruenger: I just imagined myself going through all these things like jumping from a building and taking a knife from my kitchen and ending my life. It was over 50 of them that just flooded my mind.  I don't really know if it was from all the, like, anti-socialness and not being able – it also felt like with the divorce came a lot of yelling and it felt like my parents didn't need me anymore. It's just really hard to think about that moment.

Desperate, Melissa called Austin's pediatrician who referred her to outpatient therapists and in-patient psychiatric programs – only to be told there were long waiting lists and no beds.

Melissa Bruenger: All this stuff is racing through my head. And then for them to say, "Well, there's no beds right now." And I'm like, "How am I going to keep him safe?"

In an effort to try and keep kids safe, Wisconsin is trying another approach that's being adopted in other parts of the country.

Seventeen pediatric clinics across southeastern Wisconsin have incorporated full-time therapists inside their offices. Offering mental health screenings and treatment as part of routine care. Dr. Brilliant Nimmer was the first pediatrician in Milwaukee to create a therapist's office inside her office.

Sharyn Alfonsi: You're saying, "We're here together, we're gonna all work on this together," not "We can't help you, go see somebody else."

Dr. Brilliant Nimmer: Exactly. And so having the therapist in our clinic to really just have-- get a team together to discuss that patient and family together, to bounce ideas off of each other, 'cause we both know them so well-- is so much better for patient care.

Dr. Nimmer's clinic treats an under-served community where families typically struggle to get mental health help. Therapists have treated more than 500 kids here since the pandemic started.

Dr. Brilliant Nimmer: I think as pediatricians and primary care providers we can no longer just solely say, you know, 'Mental health providers, you're the only ones that are going to be taking care of our patients in regards to mental health.' This is now something that we need to be doing too.

Austin Bruenger's pediatrician now has a therapist in her office too. Their family was fortunate to find regular outpatient therapy for his depression.

Sharyn Alfonsi: How do you feel now?

Austin Bruenger: I don't know. It's much better than before. Everything's going up in my life, knowing that, like, I'm friends with everyone in my class, I'm building better, like, social life. It's fun to just know there's others that like the same things as me.

Sharyn Alfonsi: Austin, it's not an easy thing to talk about all this stuff. Why did you agree to tell us about what you've been through--

Austin Bruenger: Because the world needs to, the world needs to know. Mental health and stuff like that needs to be treated, or bad stuff could happen. if you're going through that by yourself, try and contact someone you know, like your friend, your family.

Sharyn Alfonsi: And talk about it.

Austin Bruenger: Yeah.

https://www.cbsnews.com/news/mental-health-children-depression-suicide-60-minutes-2022-09-04/

Athira Outlines Possible Comeback For Alzheimer's Candidate

 

  • Athira Pharma Inc  announced an update to its plans for the ongoing LIFT-AD trial of fosgonimeton (ATH-1017) for mild-to-moderate Alzheimer's disease (AD).
  • Following an exploratory study looking at long-term effects, Athira plans to amend its Phase 2 trial and include new cognition, function, and neurodegeneration measurements. 
  • The primary endpoint will remain the same, but Athira will closely scrutinize its drug, fosgonimeton, in patients who aren't using another therapy to treat Alzheimer's-related dementia.
  • In June, the company announced that the exploratory ACT-AD Phase 2 study did not meet the primary endpoint of a statistically significant change in ERP P300 Latency when compared with the placebo.
  • Specifically, Athira will look at how well the drug affects those who don't take background acetylcholinesterase inhibitors (AChEIs). 
  • In a subgroup of the 77-patient of the failed exploratory study, Athira says it saw positive numerical trends in post-hoc analyses for this group in a litany of measures.
  • These included an Alzheimer's cognitive test known as ADAS-Cog11, memory processing speed measured by ERP P300 latency, and how caretakers assessed their patients' daily living.
  • Athira described neurofilament as "a validated fluid biomarker of neurodegeneration."

U.S. to expand monkeypox vaccine, drug distribution through AmerisourceBergen

 The U.S. Department of Health and Human Services (HHS) on Tuesday said it will significantly expand the number of distribution locations for monkeypox vaccines and treatments through a new $20 million contract with AmerisourceBergen Corp.

Under the new contract, HHS said it will be able to make up to 2,500 shipments per week of frozen doses of Bavarian Nordic's Jynneos vaccine from the Strategic National Stockpile (SNS), as well as shipments of SIGA Technologies' drug TPOXX to up to 2,500 locations.

The national stockpile had been shipping to only about 5 locations per state and other jurisdictions.

"This new commercial contract will help deliver vaccines and treatments to communities and at-risk individuals more quickly and bring us a step closer to ending the current outbreak," HHS Assistant Secretary Dawn O’Connell said in a statement.

Since late May, when a large multi-nation outbreak began in countries where the virus is not endemic, nearly 20,000 cases of monkeypox have been reported in the United States, according to government data.

The vaccine and TPOXX doses - as well as the distribution - are being provided to states and other jurisdictions for free.

As of Sept. 2, the SNS has shipped more than 800,000 vials of Jynneos and more than 37,000 courses of TPOXX nationwide.

By the end of August, more than 350,000 doses of Jynneos had been administered in 30 jurisdictions that are reporting data on the shots to the U.S. Centers for Disease Control and Prevention (CDC).

The U.S. Food and Drug Administration approved TPOXX in 2018 to treat smallpox, but the drug may be used for monkeypox under a special "compassionate use" protocol from the CDC.

https://finance.yahoo.com/news/u-expand-monkeypox-vaccine-drug-185005538.html

Medicare needs to catch up with hearing aid market dereg

 “You would really benefit from hearing aids, but they aren’t covered by Medicare and cost around $4,000.”

We’ve each said this phrase countless times to patients with hearing loss and are prepared for the reaction that invariably follows: an expression of bewilderment about why a pair of hearing aids may have to be their third largest material purchase in life, after a house and car.

The release earlier this month of the Food and Drug Administration’s regulations for over-the-counter  hearing aids will finally expand the options available to the 40 million Americans with hearing loss, many of whom put off buying hearing aids knowing the outrageous costs involved. This win for Americans was mandated by the bipartisan Over-the-Counter Hearing Aid Act that was signed into law in 2017 and championed by Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa).

By giving consumers direct access to hearing aids instead of having to go through clinicians, the new regulations disrupt the hearing aid oligarchy that benefited from outdated rules dating back to 1977. They allowed consumers to purchase these aids only through an audiologist or other licensed provider. As a result, five hearing aid manufacturers that meticulously cultivated relationships with hearing clinicians, or in some cases outright employed the hearing clinicians who sell their technologies, have historically controlled more than 90% of the world hearing aid market.

The release of the new regulations provides a clear path to market entry for consumer electronic companies already making innovative hearing technologies and new ones working in this area. Without the requirement of a hearing care provider as the mandated intermediary, more companies will be able to enter the hearing aid marketplace, dramatically increasing competition and innovation in a stagnant hearing aid market and driving down costs.

Fortunately, longstanding efforts by the established hearing aid industry to stymie, derail, and weaken the new FDA hearing aid regulations, documented in a recent report by Warren and Grassley, ultimately failed.

The smart use of regulatory reform to update outdated hearing aid regulations now amplifies another historical anachronism related to Medicare hearing policy. When enacted in 1965, Medicare was excluded from covering hearing aids and any related hearing rehabilitative services provided by audiologists. That poses a problem: While seniors may soon be able to purchase affordable OTC hearing aids, those who would benefit from seeing an audiologist for unconflicted professional guidance on how to manage their hearing loss with these devices cannot access such services under traditional Medicare.

There are several ways people can self-identify a hearing loss. Some will see an audiologist for testing. Some know based on their experiences and comments from others. And some will use one of the various screening tests that are available online. The Johns Hopkins Cochlear Center for Hearing and Public Health, which one of us (F.R.L.) directs, has started an initiative called the Hearing Number to help people better understand their hearing and how it changes over time.

The Build Back Better Act of 2021, which Congress did not pass, contained language that would have updated Medicare so audiological support services, as well as prescription hearing aids for those unable to benefit from OTC devices, would have been covered. This benefit was not included in the passage of a more limited version of this budget reconciliation bill, the Inflation Reduction Act of 2022, but similar language could be included in future bills that, at a minimum, should allow individuals covered by Medicare to receive hearing care support services from an audiologist.

In the end, the tally is clear. The winners include 40 million Americans with hearing loss, new companies that will finally be able to enter and compete in the hearing aid marketplace, and the public at large, which can have a renewed faith in the ability of government to implement smart policies for the greater good. Congress should repeat this impressive act with future legislation to address the historical anachronism in Medicare that prevents seniors from receiving hearing care support services.

Nicholas S. Reed is an audiologist and assistant professor in the department of epidemiology at the Johns Hopkins Bloomberg School of Public Health. Frank R. Lin is an otolaryngologist and director of the Cochlear Center for Hearing and Public Health at the Johns Hopkins Bloomberg School of Public Health, and was a member of the National Academy of Medicine’s consensus study on hearing care and testified before Congress on behalf of the OTC Hearing Aid Act in 2017.

https://www.statnews.com/2022/09/06/the-fda-got-it-right-with-hearing-aids-updating-medicare-coverage-is-next/

What happens to patients when telehealth businesses shutter?

 Buzzy, venture-backed startups and big tech companies that have promised to disrupt health care are indeed doing so — including by shuttering services that early adopter patients may have come to rely on.

Following its deal to acquire primary care tech company One Medical, Amazon announced it was ending its own virtual- and in-person health service Amazon Care, which covers 40,000 patients, by the end of the year. Telehealth prescription company Cerebral, which used pandemic-era regulatory flexibility to virtually treat mental health conditions like ADHD, has largely halted controlled substance prescriptions in light of scrutiny from federal and state regulators. Dozens of other health tech companies are cutting back their staff or shuttering business lines, doubting sustained demand from consumers and employers.

While some companies say they’re helping patients find care elsewhere, the churn could disrupt patients who lack other options for in-person care or prescribers where they live, who can’t afford other services, or who lose their health records in the shuffle between providers, experts tell STAT.

“Failure can be good, but just acknowledge that when we break things or when we fail fast in health care, we are leaving a person’s health on the other end of the line,” said Brian Hasselfeld, senior medical director for digital health and innovation for Johns Hopkins Medicine and a practicing internist and pediatrician.

Amazon told STAT that customer service teams, clinicians, and care coordinators were available to help existing patients throughout the year to help them transition, and that it would share patient records upon request. Cerebral, which launched its ADHD treatment program in 2021, is no longer writing prescriptions for controlled substances for new patients; patients with established prescriptions can continue to get them until mid-October. The company did not share more specific details on its plan for transitioning those patients to other clinicians.

Hasselfeld said patients signing up for employer-based and direct-to-consumer health services might expect more continuity, and companies could do a better job communicating those risks to patients, Hasselfeld said.

“If I have a recurring grocery store I go to, and they decide to not sell something, I can simply move to the next grocery store,” he said. “Unfortunately in a direct-to-consumer [health] model, there is often not the partnership between a consumer-patient and a medical professional to help weigh those risks and benefits.”

Patients might need to weigh the benefits of convenient, on-demand, and largely virtual care against the risk of losing it very suddenly. “They have to think about, ‘Am I engaging in this health care transactionally, am I OK if this is a temporary relationship?’” Hasselfeld said.

The confusion is also bleeding into their expectations for traditional brick-and-mortar health care, which still faces licensing and reimbursement hurdles that make it harder to treat patients virtually. Primed by direct-to-consumer services boasting continuous text-messaging and video visits with clinicians, patients are increasingly expecting traditional health care providers to be accessible digitally. “The last thing you want is a patient to have a spiking, acute urgent health care question, and for them to be surprised about what they can and cannot access,” said Hasselfeld. “Avoiding surprise is priority.”

Michael Maniaci, a physician who leads Mayo Clinic’s home-based care program, is optimistic about the innovation unfolding in virtual care, including participation by upstart providers. But he said he’s also concerned that for-profit companies that dodge in and out of patients’ lives may ultimately undermine quality and trigger a backlash.

“The fear is somebody comes in for the wrong reasons and messes things up, to where the government says, ‘We don’t think this is a good idea because of bad outcomes,’” Maniaci said. “CMS won’t back us up, commercial payers won’t back us up. Regulatory and law changes can’t happen because the wrong players are there.”

Some of this disruption is inevitable and necessary to generate new, more convenient services for patients, said Duke law professor Barak Richman. “Nobody is advocating to cement the status quo in place and there is a great need to experiment with new technologies and delivery systems … some of these experiments will work and some of them won’t,” he said. “The balance is that we have been wed to stability, and not wed enough to changes and improvements, and innovation.”

https://www.statnews.com/2022/09/06/amazon-care-telehealth-closures-patients/

New Covid vaccines are hitting pharmacy shelves. What happens to the original shots?

 Senior Biden officials are in discussions about what to do with millions of original Covid-19 vaccines after the FDA’s authorization of new, updated shots this week bumped them to the sidelines.

While the Food and Drug Administration still recommends the original composition of Moderna and Pfizer and BioNTech’s vaccines for a person’s first two doses, there’s not enough demand for the starter set to account for the millions of doses currently in the government’s stockpile or stored in pharmacies nationwide.

There are more than 20 million Moderna doses and roughly 30 million Pfizer and BioNTech doses currently in the national stockpile, according to one senior administration official. That does not include millions already dispatched to pharmacies around the nation.

The administration is unsure how to use those shots now. Between 200,000 to 300,000 people above the age of 12 are still getting their first or second shot each week, the official said — meaning there is still use for the original vaccines — but demand will plummet as the updated vaccines move across the country.

By the middle of this past weekend, nearly 4 million doses of the variant-targeting bivalent vaccines will be dispatched to roughly 15,000 sites, the official said. That’s a fraction of the overall 175 million doses of the new vaccines the government ordered to battle the BA.5 and BA.4 wave and curb an expected fall case surge.

Nearly 80% of Americans have received at least one vaccine, while 67% are considered fully vaccinated. Those numbers have hardly budged for months as vaccine holdouts resist outreach campaigns — leaving the question of whether the stockpiled primary doses could become obsolete.

“My fear is that the bivalent vaccine ends up in populations that probably need it less,” said William Moss, executive director of Johns Hopkins University’s International Vaccine Access Center and vaccinology lead for the university’s coronavirus resource center. Moss, like other infectious disease experts, questioned the need for broadly boosting with the new vaccine when young and healthy people are already spurning other booster recommendations.

Concerns about the doses expiring before they can be used have U.S. officials mulling more international donations. But they’re worried, too, about depleting the existing stockpile, which for now is expected to last at least through mid-December.

The dilemma comes amid faltering global demand for vaccines as well. While U.S. officials say there is still international interest in receiving vaccine donations, many countries have admitted that supply is not the pressure point, but public demand for vaccines.

“We’ve gotten to the point where there’s a glut of supply from a global perspective, that hasn’t translated all the way down to every local context,” said Krishna Udayakumar, founding director of Duke University’s Global Health Innovation Center. “This has become more of a … distribution and delivery challenge as opposed to purely supply challenge.”?

U.S. government vaccine decisions have also dramatically shaped global perception, such as when an American pause on the Johnson & Johnson shot saw international demand crash. There is some concern that shipping out the original vaccines just as updated shots land could be a communications challenge.

“We have a real risk that they will be perceived as being … better, because they’re being purchased by the U.S. and potentially other high-income countries,” said Udayakumar. “We do have a challenge [around] the communications in the short term, even if the science doesn’t bear out the difference yet.”

He and other public health experts question whether the variant-targeting vaccines — either the U.S. versions or the BA.1-tailored shot ordered by the World Health Organization — will actually be game-changers that exacerbate disparities. There still are not solid human data for their benefit, while the original mRNA vaccines have plenty of safety and efficacy data and have become favorites in the U.S. and abroad.

“I don’t think there’s any reason to believe that the kind of duration of protection from the bivalent vaccine is going to be much different than what we’ve seen with with earlier vaccines,” said Moss. “But I’m optimistic that the virus is running out of options.”

https://www.statnews.com/2022/09/03/what-happens-to-extra-covid-vaccines/