The US Food and Drug Administration has greenlit the first test for chlamydia and gonorrhea that will allow users to collect samples at home. After HIV, this is the first FDA-authorized test that will allow more accessible home collection for a sexually transmitted infection.

The Simple 2 Test, made by New York- and Dublin-based LetsGetChecked, got FDA market authorization Wednesday.

Up until now, people concerned that they might have chlamydia or gonorrhea would have to get tested at a doctor’s office.

Users of the new test won’t need a prescription and can activate it online. They fill out a health questionnaire for a clinician to go over, collect a vaginal swab or urine sample using the Simple 2 collection kit and then send it in to be evaluated. Test results are delivered online. If the test is positive or if the results are invalid, a health care provider follows up.

“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement.

Home diagnostic tests have become a more widely used option during the Covid-19 pandemic, and Shuren said the FDA is eager to support more opportunities for people to get access to diagnostic tests at home.

Peter Foley, founder and CEO of LetsGetChecked, told CNN in an email that the test “will empower individuals to proactively manage their health from home. We greatly appreciate FDA’s collaboration throughout this process.”

Gonorrhea and chlamydia are very common infectious diseases that can be passed from one partner to another through oral, anal and vaginal sex without a condom. Both infections can be treated with antibiotics.

Increased sexual activity during the pandemic, coupled with fewer routine screenings for sexually transmitted infections, supercharged the spread of these diseases around the world.

There were more than 700,000 cases of gonorrhea reported to the US Centers for Disease Control and Prevention in 2021. Rates have increased 118% since their record low in 2009, the agency says.

Symptoms of gonorrhea can include stomach or pelvic pain, increased vaginal discharge, painful urination and bleeding between periods. Many people don’t notice any symptoms, making routine screenings important to catch infections.

Without treatment, the infection can cause serious and permanent health problems. If it spreads to the blood, it can cause disseminated gonococcal infection, which can lead to arthritis, skin problems and tenosynovitis, which can cause pain and swelling. The condition may even become life-threatening.

Cases of chlamydia have also been on the rise, the CDC says. In 2021, there were more than 1.6 million cases reported to the agency, making it the most common notifiable sexually transmitted infection in the US that year. Symptoms include pain or burning while urinating, pain during sex, belly pain, abnormal vaginal discharge, swollen or tender testicles, and bleeding around the anus.

Chlamydia can also cause permanent damage to a woman’s reproductive system and make it difficult to get pregnant later. It can also cause an ectopic pregnancy, where the pregnancy happens outside of the womb.

Republicans in Congress are “trying to wipe out federal funding to end the HIV epidemic.”

President Joe Biden on Oct. 14, 2023, in remarks at the 2023 Human Rights Campaign National Dinner.

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Are Republicans threatening to stop spending federal money to end one of the world’s most pressing public health epidemics? That’s what President Joe Biden said during a dinner hosted by an LGBTQ+ advocacy group.

“In the United States Congress, extreme MAGA Republicans are trying to undo virtually every bit of progress we’ve made,” Biden said Oct. 14 at the Human Rights Campaign event. “They’re trying to wipe out federal funding to end the HIV epidemic.”

Programs to treat HIV and fight its spread have enjoyed bipartisan funding support in recent years, experts said, so Biden’s portrayal signals a significant departure.

When we asked the White House what Biden was referring to, it pointed us to reports of budget recommendations from House Republicans that call for large cuts to the Ending the HIV Epidemic initiative, a Trump administration-era program designed to reduce new HIV infections in the U.S., as well as other programs.

The Senate Appropriations Committee passed a separate spending plan. The recommendations will be subject to negotiation as the House and Senate face a Nov. 17 deadline to pass another spending bill.

We found that although Republicans are recommending significant cuts to HIV prevention efforts across a number of public health agencies, the proposal keeps core funding intact. Meanwhile, political differences are eroding bipartisan support for global HIV-prevention funding.

Despite great strides in prevention and treatment since HIV was first reported in the U.S. in the 1980s, HIV remains at epidemic levels in the U.S. today, with approximately 1.2 million people living with HIV and around 30,000 to 35,000 new infections each year. Experts said cases are rising in the South and in rural areas, and new infection statistics show it is disproportionately affecting Black and Hispanic populations.

What Are the Proposed Cuts?

The AIDS Budget and Appropriations Coalition, a group of more than 100 public health advocacy organizations that track changes in HIV-related federal spending, said a majority of the proposed cuts to domestic HIV funding stem from House Republicans’ effort to eliminate the Ending the HIV Epidemic initiative.

The program started in 2019 with the goal of reducing new HIV infections in the U.S. by 75% by 2025 and 90% by 2030. The program so far worked regionally, targeting areas that have the highest rates of HIV cases for funding.

In 2023, about $573 million was allocated for the program across various agencies, according to KFF’s funding tracker.

• $220 million to the Centers for Disease Control and Prevention.
• $165 million to the Ryan White HIV/AIDS program. (It was named for a 13-year-old diagnosed with HIV in 1984 and is overseen by the Health Resources and Services Administration.)
• $5 million to the Indian Health Service.
• $26 million to the National Institutes of Health for research.
• $157.3 million to community health centers, which have treated around 200,000 HIV patients annually.

The program lags its goals as it approaches the 2025 benchmark. “It’s well designed, well planned, it has targets that makes sense,” said Jeffrey Sturchio, a lead researcher on a Center for Strategic and International Studies report.

Sturchio said the problem is not a fault of design, but funding, adding, “Congress has never fully funded the initiative.”

Sturchio pointed to a range of local and state “bureaucratic hurdles.” Jurisdictions that have pulled together sufficient resources have seen “tremendous progress,” he said, and overall indicators seem to be moving in the right direction.

But COVID-19 reduced HIV testing and may have diverted public health efforts, CDC administrators said. KFF Health News reported in April that stakeholders saw progress but worried that it won’t be enough to make the 2030 deadline.

Democrats appear to share this concern. The spending bill proposed by the Democratic-controlled Senate Appropriations Committee maintained or slightly increased funding levels to all HIV-related programs. The committee requested more data about the program, describing its “lack of quantifiable data showing outcomes.”

The House has not yet passed the bill out of committee. We know of some proposed cuts from the bill, which the Republican-led House Appropriations Subcommittee released in July.

It outlines a $1.6 billion cut to the CDC, including a $220 million reduction in “HIV/AIDS, viral hepatitis, sexually transmitted diseases, and tuberculosis prevention” and a $238.5 million cut from the Ryan White HIV/AIDS program. The Ryan White program provides medical care and support services to low-income HIV patients and serves more than half of those diagnosed in the U.S.

The bill also proposes cutting funding to the Minority HIV/AIDS fund by more than half — from $60 million to $28 million. According to HIV.gov, the fund supports prevention and care projects targeting disparities that affect communities of color.

Additional details about how these cuts could affect programs are detailed in a committee report that has not been made public. PolitiFact and some advocacy organizations obtained copies of the report, but the House Appropriations Committee did not respond to questions about it. The report we saw recommended cutting all funding for the Ending the HIV Epidemic initiative.

And House Democrats, advocacy organizations, and KFF Health News have each reported that the Ryan White program and CDC cuts result from a plan to eliminate the Ending the HIV Epidemic initiative.

“If they cut funding, it’s going to have a dramatic and draconian impact on the ability of all of the people who are working in these jurisdictions to improve public health,” said Sturchio, the researcher.

Although the cuts would be dramatic, experts said, they would not eliminate all domestic HIV funding.

“There is certainly a demonstration and a commitment to some of the core HIV programs, but there are millions of dollars of proposed cuts in other areas,” said Lindsey Dawson, associate director for HIV policy at KFF. “These cuts would have a meaningful impact on the ability of programs to provide lifesaving interventions for both HIV care and treatment, as well as prevention.”

The cuts would mean a 16% cut to the CDC’s division of STD prevention, a 9% cut to the Ryan White HIV/AIDS program, and a 53% cut to the Minority HIV/AIDS Fund from fiscal year 2023 to 2024.

These funding cuts are only proposals. They require a vote from the full appropriations committee and would have to pass the House and be negotiated with a Democratic-controlled Senate.

“We’ve heard for a long time that HIV is a bipartisan issue. But what some people forget, is that that bipartisanship was hard fought for over the first decade of the HIV epidemic,” said Dawson.

Other Challenges to HIV/AIDS Spending

The U.S. commitment to global HIV prevention, meanwhile, is also under scrutiny. Rep. Chris Smith, R-N.J., challenged reauthorizing the President’s Emergency Plan for AIDS Relief, also known as PEPFAR, without first making some changes. Started in 2003 by President George W. Bush, the program distributes funds in more than 50 countries for HIV testing, prevention, treatment, and medications. It also strengthens health care systems to fight AIDS.

Funding for the program has grown over the past 20 years, totaling more than $110 billion. The program reported 25 million lives saved by medical intervention.

Smith, who chairs the House Foreign Affairs subcommittee on Global Health, has expressed concerns that money is being given to nongovernmental organizations that support abortion rights and access.

U.S. law prohibits the direct use of overseas funding to provide abortions or to lobby for access to abortions. This has been the case since 1973. However, organizations that receive U.S. funding can do so with their own non-U.S. funding.

An official from the State Department, which runs the program, confirmed to PolitiFact that PEPFAR is legally restricted from funding abortion or lobbying for abortion access; the official cited the training of staff and partners and the monitoring of procedures to ensure compliance.

Other anti-abortion groups have favored a“Mexico City Policy,’‘ which has required foreign nongovernmental organizations to certify that they would not perform or promote abortion with funds from any source to be eligible for U.S. government funding. Trump applied the policy to PEPFAR, but Biden rescinded it.

The lack of a reauthorization would have significant symbolic impact, said Kellie Moss, KFF’s associate director of global health and HIV policy. “It could make the program more vulnerable during funding discussions without a clear signal of bipartisan support.”

Although reauthorization is being held up, funding has progressed. On Sept. 28, the House passed a State Department and Foreign Operations Appropriations bill, which would fund PEPFAR for another year but implement a Mexico City-like policy provision on all global health funding. This bill would also extend the lapsing provisions for another year.

Our Ruling

Biden said that Republicans in Congress are “trying to wipe out federal funding to end the HIV epidemic.”

A subcommittee of House Republicans has proposed cutting some HIV prevention programs anywhere from 53% to 9% in fiscal 2024, depending on the program.

A committee’s draft report cited by advocacy and policy groups shows these cuts stem from the elimination of the Trump-era Ending the HIV Epidemic initiative, although the committee did not respond to questions about that.

Taken together, these cuts would not eliminate — or “wipe out” — all federal domestic HIV spending, but they do represent a significant cut.

Meanwhile, the House has not moved ahead to reauthorize PEPFAR, which supplies U.S. dollars for global HIV prevention, over Republican concerns about where organizations that receive the money stand on abortion access. But the House has passed one year of PEPFAR funding with some conditions about how it is distributed, which it can do without reauthorizing the program.

Biden’s statement is partially accurate in that significant funding cuts have been proposed by House Republicans, but he exaggerates by saying these efforts would “wipe out” federal funding.

We rate this claim Half True.

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(KFF Health News, formerly known as Kaiser Health News (KHN), is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs of KFF — the independent source for health policy research, polling and journalism.)

©2023 KFF Health News. Distributed by Tribune Content Agency, LLC.

A proposed federal policy aims to protect older Americans from contracting HIV by offering free preventive medication, the latest effort to catch up to much of Europe and Africa in stemming the spread of the virus.

Under the plan from the Biden administration, Medicare would cover patients’ full cost of preexposure prophylaxis drugs, which prevent HIV transmission. The drugs, known by the shorthand “PrEP,” would be free in pill form and — for the first time — as long-acting injectables through the government insurance program designed for those 65 and older. Those 50 and over make up half of all people in the U.S. already living with HIV.

The proposed policy change represents a big shift because it means that even new long-acting injectable versions of PrEP drugs, which can cost more than $20,000 a year in the U.S., would be covered fully, without requiring patients to kick in copayments. It is not yet clear what the plan would mean for taxpayers, though, either in paying for the medications or in offsetting the costs of caring for fewer Medicare patients with HIV in the future.

The final green light for the plan was expected Oct. 10, but the Centers for Medicare & Medicaid Services announced it is still working out details of how to transition coverage for patients already taking the drugs.

The U.S. is decades behind nations in Europe and Africa that are on track to end new HIV infections by 2030. But while the proposal should bring down infections in older Americans, it highlights remaining inequities: Many people under age 65 will still struggle to pay for PrEP. And, at the same time, Republican congressional leaders have threatened to cut funding for a federal HIV prevention effort championed by the Trump administration that is intended to help all at risk.

“We’ve done a very poor job in the U.S. of assuring that people who could most benefit from PrEP have access to it,” said Justin Smith, who directs the Campaign to End AIDS at Positive Impact Health Centers in the Atlanta area.

Though PrEP has been embraced by gay and trans Americans, it is prescribed less often to heterosexuals over 50 or women of any age. In the first three months of this year, just 8% of the more than 300,000 people receiving PrEP in the U.S. were women, according to the Centers for Disease Control and Prevention. The racial gap is large, too: While 66% of white people eligible for PrEP got prescriptions for it in that period, only 8% of eligible Black people and 17% of eligible Hispanic people did.

Broadening access for gay and bisexual men of color, as well as straight and cisgender women of color — particularly Black women, who represent the majority of women with HIV in the U.S. as well as the majority of new infections among women — is critical for the nation to catch up to the rest of the world, Smith said.

PrEP, a Key HIV Prevention Tool, Isn’t Reaching Black WomenNew HIV infections occur disproportionately among Black women, but exclusionary marketing, fewer treatment options, and provider wariness have limited uptake of preexposure prophylaxis, or PrEP, drugs, which reduce the risk of contracting the virus.

Leisha McKinley-Beach, a national HIV consultant and CEO of the Black Public Health Academy, which prepares Black health department employees for leadership positions, noted that the Medicare proposal to cover the cost of injectable PrEP could help many women because a shot given every two months can be easier to manage than a daily pill.

But it’s just a start. She and others are lobbying for a national PrEP plan that would build on momentum from the recent Medicare proposal to expand free access to other age groups, much as with covid-19 vaccinations. McKinley-Beach also wants the U.S. government to expand the message that anyone can get HIV, encourage drug companies to advertise more on TV to women of color, and fund outreach to dispel medical mistrust in communities of color.

“Gay white men have had a narrative of dignity and respect with regards to HIV treatment, and I would never want to change that narrative,” she said. “But the message needs to be broadened. Forty-two years into the HIV epidemic, the current HIV prevention model is detrimental to Black women who could benefit from PrEP.”

Though the U.S. was the first nation to approve PrEP, in 2012, it now trails the rest of the world in equitable access. That’s mostly due to the cost of laboratory tests and medical visits. While the cost of the generic form of Truvada, an oral form of PrEP, can be as low as about $30 a month in the U.S., a study by University of Virginia researchers reported the cost of starting PrEP is typically about $2,670 for uninsured patients, including about $1,000 for lab tests and medical visits. The new Medicare proposal would cover up to seven counseling visits every 12 months for HIV risk assessment and reduction.

Meanwhile, PrEP pills are free for people in the United Kingdom and European Union nations including France, Germany, Sweden, and Denmark. Those nations don’t yet cover the more expensive shots, although the U.K. is leading a small test on injectable PrEP in people who cannot take it in tablet form.

The U.S. also lags Western Europe and some nations in Africa in overall HIV treatment and prevention. For example, just 57% of HIV-positive Americans have attained viral suppression, according to the U.S. government website HIV.gov, meaning they regularly take medications to make them unable to transmit the virus. That makes PrEP, which is for people who don’t have the virus, all the more important for Americans to stay negative, according to HIV experts.

In Africa, by contrast, Botswana, Eswatini (formerly Swaziland), Rwanda, Tanzania, and Zimbabwe have already achieved the United Nations’ “95-95-95” targets set for 2025 — 95% of people with HIV know their HIV status, 95% of people with diagnosed HIV infection receive sustained antiretroviral therapy, and 95% of people receiving antiretroviral therapy have achieved viral suppression, or the virus is undetectable in their blood — according to the U.N.

In the U.K., 98% of HIV-positive people have achieved “undetectable” status via free antiretroviral medicines and treatment available through the country’s universal health care program, the National Health Service. Moreover, nearly anyone in the U.K. who is HIV-negative and wants to take PrEP can get it at no charge. The U.K. says it is now on a path to reduce new HIV infections by 80% by 2025.

The U.K. changed its PrEP approach after 2015, when Greg Owen founded “iwantprepnow.co.uk,” a website that ignited a PrEP movement by helping people in the U.K. and Europe self-source low-priced generic forms of Truvada, the first drug approved as PrEP, from pharmacies in Hong Kong and India.

“It became more affordable,” said Owen, now PrEP lead at one of the U.K.’s top HIV and sexual health charities, Terrence Higgins Trust. “Soon people demanded it for free on the NHS.”

In the U.S., Smith said, the lack of a national PrEP program that would make the drugs and associated bloodwork free and a heated political climate around health care have hindered HIV outreach.

“In rural areas of the South, especially in places like Georgia or Tennessee, there has been outright hostility toward accepting money from the CDC and expanding Medicaid to treat and prevent HIV,” Smith said. “People think it’s just politics, but this is having an impact on public health, on people’s lives.”

Anti-queer sentiment in many quarters also creates an environment of hostility around overall sexual health, said Richard Elion, director of clinical research at Washington Health Institute and a professor at George Washington University School of Medicine and Health Sciences. “There’s a chilling effect for everyone, not just queer Americans,” he said.

Elion said shame surrounding sex and the feeling of vulnerability that some people get from taking any medicine may also reduce PrEP uptake among older Americans. “Taking PrEP is actually very empowering, and that needs to be the message,” he said.

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(KFF Health News, formerly known as Kaiser Health News (KHN), is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs of KFF — the independent source for health policy research, polling and journalism.)

©2023 KFF Health News. Distributed by Tribune Content Agency, LLC.

Lawmakers earlier this year ordered the agency to review protocols, regulations and laws dealing with feral hogs as well as mink farms, and report back in 2024 on any changes that should be made to make sure the state is ready. The Department of Agriculture, Board of Animal Health and Department of Health also are part of the effort.

Canadian researchers have called wild pigs “ecological train wrecks” that can cause soil erosion, degrade water quality, destroy crops and prey on small mammals and birds.

The researchers at the University of Saskatchewan’s Canadian Wild Pig Research Project made headlines earlier this year when they reported the nation’s population of large, wild pigs was growing rapidly and essentially uncontrollable — nicknamed “super pigs” because they can grow to 400 pounds, run 30 mph and have adapted to live in bitter cold and deep snow. They are apparently the progeny of intentionally cross-bred Eurasian boars and domestic pigs, escaped hybrids that have adapted to the wild.

Some of the super pigs are within 50 miles of the Minnesota border, and some have already dipped into North Dakota, officials note. Other populations of feral hogs are established in Michigan’s Upper Peninsula.

There are now an estimated 6 million feral hogs roaming in the U.S., wildlife officials said. In the 1980s, feral swine were in only 20 states, primarily in the South. Now they are in 36 states as the animal’s range expanded west and north. The number of counties affected by wild hogs has nearly tripled from 550 in 1982 to 1,496 in 2023.

Female pigs can give birth when they are just six months old and can produce two litters of four to 12 piglets a year, a trait that can lead to rapid population expansion. They can cause massive damage to wildlife habitat and forest ecosystems while spurring severe erosion and damaging water quality by rooting near streams.

To make matters worse, all that rooting around in the soil releases greenhouse gases, as much as 1 million cars annually, one report concluded.

They are also a menace to crops, causing an estimated $1.5 billion in agriculture losses annually in the U.S. alone. Farmers report that a group of 10 to 20 wild pigs, called a sounder, can destroy 10 acres of corn in one night. And they are a reservoir of diseases that can spread to domestic hogs and even other species.

But it’s not just wild pigs moving in from other places that worry agriculture and wildlife experts in Minnesota. Escaped domestic pigs can rapidly become wild. That’s what happened in northwestern Minnesota in 2016 when an escaped female pig, one of several that breached a farmer’s fence, survived the winter and had piglets in a state wildlife management area.

The escaped pigs were eventually discovered and tracked down by federal trappers who killed them. Officials learned that the pigs had likely been surviving in the wild for a year or more. The farmer was cited, convicted and fined $135 for allowing his pigs to roam free and become wild. But the situation underscored how quickly any pig can adapt once they are loose.

“It’s sometimes impossible to tell the difference between a domestic pig and a Eurasian wild pig. But it really doesn’t matter. Any pig that is loose in the wild has the potential to be the beginning of a major problem,” said Leslie McInenly, wildlife populations and regulations manager with the DNR. “It’s not just wild ones moving in from other places. It’s Minnesota farm pigs that escape and turn wild.”

It’s illegal to hunt wild pigs in Minnesota. Experts note that allowing the public to shoot wild hogs has not worked to reduce their numbers in most areas and may make wild pigs more wary of people.

US officials are finalizing an agreement with China to crack down on the export of the source chemicals used to make fentanyl, according to two people familiar with the matter.

The deal, which has been a priority for the Biden administration, is expected to be finalized and announced in coordination with President Joe Biden’s summit meeting in San Francisco Bay Area Wednesday with Chinese President Xi Jinping.

The agreement will target companies that produce and export the source material to make the deadly synthetic opioid, said the people, who cautioned that the deal would not be finalized until its announcement. The goal would be to significantly limit the flow of precursor materials to Mexico, the people said.

The agreement is one of several administration officials have sought to finalize with their Chinese counterparts in advance of Biden’s first meeting with Xi in a year. The visit will also mark Xi’s first visit to the US since 2017 and comes as the world powers have attempted to cool tensions that have driven concern about increased risks of dangerous escalation for much of the last year.

It could also mark an important domestic political win for Biden, whose administration has grappled with trafficking of lethal illicit drugs like fentanyl in an ongoing crisis at the southern border that has weighed down his administration.

“I won’t get too far ahead of the meeting, and I’ll let the president speak for himself after he has the chance to meet with President Xi, but we believe that there are areas where our interests overlap, like our efforts to combat the illicit fentanyl trade,” national security adviser Jake Sullivan told reporters Monday.

US officials are also seeking to re-open military communication channels, which have been all but dark in the wake of former Speaker Nancy Pelosi’s visit to Taiwan in 2022. The effort to reestablish the channels has been a focal point of tenuous US diplomatic efforts for months.

“When it comes to managing the relationship, ties and communications between our two militaries are critical,” Sullivan said in an interview Sunday with CNN’s Dana Bash on “State of the Union.” “The Chinese have basically severed those communication links. President Biden would like to reestablish them, and he will look to this summit as an opportunity try and advance the ball on that.”

An adult day care center is slated to be developed within a large, empty building in Vietnam Town, a well-known commercial complex in the Little Saigon district near the corner of McLaughlin Avenue and Story Road, documents on file with city planners show.

The proposal envisions a health care complex totaling 45,200 square feet at 939 Story Road, according to documents on file with city officials. The proposal was slated to be granted final approval by city planners at a meeting on Nov. 15.

Northeast Medical Services, a nonprofit whose affiliate owns the property that will accommodate the health care facility, proposed the development, documents on file with the city and Santa Clara County show.

The nonprofit’s affiliate bought the property in June 2022, paying $20 million for the site in an all-cash transaction.

Vietnam Town Property sold the building to the nonprofit’s affiliate. The property is in the northwest corner of Vietnam Town, a center of shops, restaurants and offices.

The seller originally purchased the entire Vietnam Town site in 2014 in the wake of the bankruptcy of a prior owner of the commercial center and the foreclosure on a loan for the property.

Over the years since Vietnam Town Property bought the entire center, the company has sold scores of small commercial condominium parcels that make up the complex.

The small sites were marketed to merchants who preferred to own rather than lease their business locations. The sites also were marketed to real estate investors who wished to own small properties.

Northeast Medical Services (NEMS) will use the building as a site for health care directed toward the elderly, which is the primary focus of the nonprofit’s NEMS PACE program.

“PACE is a nationally recognized model of care for older adults with chronic health needs,” Northeast Medical Services states in a post on its website.

The nonprofit’s health care offerings for senior citizens are custom-tailored for each recipient of the services, the organization states. Clients have access to a team of health care professionals through the NEMS PACE program.

“The care team works together to develop a comprehensive and personalized care plan to meet your unique medical, social, and emotional needs,” Northeast Medical Services says in the web post.

Emily Bendt was in her third trimester of pregnancy when she first heard the Centers for Disease Control and Prevention had approved a new shot for infants to protect them from the respiratory syncytial virus, or RSV.

By Oct. 5, Bendt was cuddling with her new baby, Willow, on the couch at home in Vancouver, Washington. She was excited to get Willow the new therapy for infants, called nirsevimab, which had started shipping in September — but Bendt, a pediatric home health nurse, couldn’t find it anywhere.

That very morning, at Willow’s two-week checkup, Bendt had asked the pediatrician when Willow could get it. “She literally just shrugged and was like, ‘Well, it’s coming, but we don’t know when,’” Bendt said. “I don’t know why I feel like I’m having to chase people down and still not get answers.”

Bendt searched online, too, for clinics or pharmacies or government websites offering nirsevimab — and found nothing.

By mid-October, demand for nirsevimab, sold under the brand name Beyfortus, had already outstripped supply, according to the pharmaceutical company Sanofi, which developed the drug with AstraZeneca.

In response, the CDC issued interim guidance Oct. 23 to help pediatricians allocate the limited supply of doses, advising them to focus on the infants at highest risk of RSV complications: those under 6 months old, and those with underlying medical conditions.

RSV is the leading reason babies under 12 months old end up in the hospital, and an estimated 100-300 kids under age 5 die from it in the U.S. every year.

Nirsevimab, a monoclonal antibody, is one of two new therapies available this fall that could dramatically reduce the risk of lung infections in infants.

The other option is an RSV vaccine from Pfizer called Abrysvo. It was first recommended for adults 60 and older, and then Sept. 22 the CDC approved its use in pregnant people, too, to confer some immunity on their infants.

But this adult vaccine is recommended only within a relatively short window in pregnancy, weeks 32 through 36, because of a potential but unproven concern it may increase preterm births. That might limit uptake during pregnancy.

By the time the vaccine was approved for pregnant people Sept. 22, Emily Bendt had given birth. So for Willow and other babies like her, nirsevimab will be the only option for protection from RSV this respiratory virus season.

Nirsevimab is approved for all infants up to 8 months old, and for some older babies and toddlers considered at higher risk of severe illness from RSV. The American Academy of Pediatrics recommends that every baby whose mother did not get the RSV vaccine while pregnant receive nirsevimab in the first week of life.

The CDC is now asking prenatal care providers to warn their patients about potential nirsevimab supply shortages, with the hope that driving up the maternal vaccination rate could help ease the demand for nirsevimab.

Nirsevimab’s powerful but pricey potential

Pediatricians say the high cost of nirsevimab and bureaucratic obstacles in Medicaid’s vaccine allocation system for children are slowing down nirsevimab’s distribution. They fear these problems leave infants at risk — unnecessarily — of hospitalization this winter.

In clinical trials, nirsevimab reduced RSV hospitalizations and health care visits in infants by almost 80%.

“This is groundbreaking, honestly,” said Katie Sharff, chief of infectious disease for Kaiser Permanente Northwest.

Nirsevimab is a monoclonal antibody treatment, not a traditional vaccine. The passive immunity it confers lasts about five months. That’s long enough to get babies through their first RSV season, when they’re at highest risk for complications.

After an infant’s first winter, “their airways develop and their lungs develop,” Sharff said. “So getting RSV later, as a child instead of as an infant, [means the child is] probably less likely to have severe complications of difficulty breathing, needing to be on a ventilator.”

Sharff’s own daughter had an RSV infection as an infant, needed care in the emergency department, and went on to develop asthma, a condition more common in children who had severe RSV infections.

For health systems worn down by the “tripledemic” of respiratory viruses — covid-19, flu, and RSV — keeping infants out of the hospital this winter could be a game-changer.

Last year was a historically bad season for RSV. Earlier in the pandemic, measures that states took to slow the spread of covid, such as masking, depressed RSV infections for a while, too. But as infection-control measures were rolled back, more babies and toddlers were exposed to RSV for the first time, at the same time.

In Oregon, the surge prompted then-Gov. Kate Brown, a Democrat, to declare a public health emergency and forced hospitals to add capacity to their pediatric intensive care units. Some hospitals even sent patients out of state.

“The promise of nirsevimab is that should never, never happen again,” said Ben Hoffman, a professor of pediatrics at Oregon Health & Science University’s Doernbecher Children’s Hospital in Portland and the president-elect of the American Academy of Pediatrics.

But that depends on the therapy’s availability, and whether providers can get it to newborns efficiently.

The most expensive childhood vaccine

For babies born without the protection of the maternal RSV vaccine, the American Academy of Pediatrics says the best time to get nirsevimab is at birth, before an infant is exposed to RSV at all.

But babies like Willow who were born before nirsevimab became available will need to get it from an outpatient clinic.

Except for the first dose of the hepatitis B vaccine, administration of childhood vaccines start one month after birth, in a pediatrician’s office, but the cost of nirsevimab might make that hard.

At $495 per dose, it’s the most expensive standard childhood shot, and insurers may not reimburse providers for it this year. That’s a particular problem for small pediatric practices, which can’t afford to lose that much money on a standard childhood vaccine.

“When all of a sudden you have a new product that you’re supposed to give to your entire birth cohort, and you’ve got to pay $500 that may or may not get paid back, that’s just not financially viable,” said Sean O’Leary, a pediatric infectious-disease specialist at the University of Colorado School of Medicine.

Some insurers, but not all, have announced they will cover nirsevimab right away. Because of a quirk in the Affordable Care Act, commercial insurance plans can wait up to a year after a new therapy is approved before they are required to cover it.

Sanofi has announced an “order now, pay later” option for doctors, which would give them more time to work out reimbursement deals.

Could hospitals help?

A government program that supplies free shots to about half the children in the United States is structured in a way that makes it hard to get nirsevimab to babies right after birth.

Vaccines for Children is a safety-net program that provides vaccines to kids on Medicaid, uninsured children, and Alaska Native and American Indian children.

Health care providers can’t bill Medicaid for shots like nirsevimab. Instead, they must register and enroll in the VFC program. Through it, the federal government purchases shots from companies like Sanofi at a discount, and then arranges for them to be shipped free to VFC-enrolled providers, which tend to be pediatric practices or safety-net clinics.

But most hospitals aren’t part of VFC, which presents a problem.

“Many of our newborns go home to caring, affectionate, loving siblings who are actively dripping snot at the time that the child is born,” said Eddie Frothingham, a pediatrician with Mid-Valley Children’s Clinic in Albany, Oregon. “The sooner we can protect them, the better.”

Right now, only about 10% of birthing hospitals nationwide are enrolled in VFC and can get nirsevimab free.

Until nirsevimab’s debut a few months ago, most hospitals didn’t have a strong incentive to participate in Vaccines for Children because childhood vaccines outside of hepatitis B are typically given to kids by pediatricians, in outpatient clinics.

VFC can be burdensome and bureaucratic, according to interviews with several Oregon hospitals and immunization experts. The program’s stringent anti-fraud measures discourage health care providers from enrolling, they say.

Once enrolled, providers must track and store VFC-provided vaccines separately, apart from other vaccine supplies. The person giving a pediatric shot has to know what insurance the child has, and account for each dose in a state-run electronic record system.

Mimi Luther, immunization program manager for Oregon, said the rules are nearly impossible for most hospitals to follow.

“I look forward to the day when the feds have the opportunity to modernize that system to make it easier for providers to enroll and stay enrolled,” she said.

The CDC has relaxed some program rules in light of the shortage of nirsevimab, allowing providers to “borrow” up to five VFC doses for infants covered by private insurance — as long as those doses are paid back within a month.

Frothingham said that also creates an equity problem. Newborns whose parents don’t have transportation, or financial resources, are more likely to miss those first pediatric appointments after birth.

Samaritan Health Services, the health system Frothingham works for, has decided to privately purchase a small number of doses to offer in its hospitals, for newborns whom doctors flag as high risk because of breathing problems or family poverty.

“It’s important to us that infants be able to access this regardless of their financial or social circumstances,” Frothingham said.

Nationwide, many birthing hospitals are trying to enroll in the VFC program for next year. But this fall, most won’t have free nirsevimab on hand.

Most babies who get RSV ultimately recover, including those who require hospitalization to help with their breathing. But it’s challenging to treat, and each year some babies die.

In his decades in medicine, OHSU’s Hoffman has lost infant patients to RSV.

“Knowing that some kids may potentially suffer because of delayed access or absence of access to a product that could potentially save their lives is awful,” Hoffman said. “No pediatrician in the country is happy right now.”

This article is from a partnership that includes OPB, NPR , and KFF Health News.

___

KFF Health News, formerly known as Kaiser Health News (KHN), is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs of KFF — the independent source for health policy research, polling and journalism.

©2023 KFF Health News. Distributed by Tribune Content Agency, LLC.

Women in the United States can expect to live nearly six years longer than men, as disparities in deaths from COVID-19 and drug overdoses drive the life expectancy gap to the widest it’s been in decades.

Overall, life expectancy in the US fell more than two and a half years since the start of the pandemic — down to 76.1 years in 2021, according to data from the US Centers for Disease Control and Prevention. Life expectancies for both men and women were affected, but not equally.

The lifespan for women has been consistently longer than men, with the lowest difference of 4.8 years in 2010. But the gap grew by 0.2 years in the decade that followed and by 0.7 years in the first two years of the COVID-19 pandemic.

In 2021, life expectancy for women was 79.3 years, compared with 73.5 years for men — a gap of 5.8 years, the largest since 1996.

Differences in cardiovascular and lung cancer death rates, largely related to patterns in smoking behavior, have been key reasons why women have outlived men in the US over the past century.

But men have had significantly higher mortality rates from many other leading causes of death in recent years, according to a new study, and multiple converging factors are driving a wider gap.

Between 2010 and 2019, the largest drivers of the growing life expectancy gap were higher mortality rates among men for unintentional injuries, diabetes, suicide, homicide and heart disease. Some of that gap was offset by more similar mortality rates from cancer and Alzheimer’s disease among men and women.

Men were more than twice as likely to die from unintentional injuries than women in 2010 and that gap was even greater in 2021, leading to a 0.27-year difference in life expectancy since 2019. The vast majority of unintentional injuries were drug overdoses.

Increasing maternal deaths among women and some improvement in cancer deaths among men “partially mitigated the increasing gap,” according to the study.

“This analysis finds that COVID-19 and the drug- overdose epidemic were major contributors to the widening gender gap in life expectancy in recent years,” the study authors wrote. Some reasons for this difference could include higher rates of comorbidities and health behaviors among men, as well as some socioeconomic factors such as rates of incarceration and homelessness, they said.

“The increase in overdose deaths, homicide, and suicide underscore twin crises of deaths from despair and firearm violence,” the authors wrote.

The study was limited by a binary classification of gender and did not explore overlap across disease classifications and different demographic subgroups.

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“It’s kind of like a pressure cooker. If you don’t slowly let go of that steam little by little, when it does pop, it’s over because it’s going to be such a big explosion.”

Delgado was one of the first officers on the scene of the Pulse nightclub attack in Orlando on June 12, 2016. He suffers post-traumatic stress disorder from that night, and has attempted to take his own life twice.

“They just popped,” he said.

In announcing the deaths of three current members and one retired member, the LA County sheriff’s department said homicide detectives are investigating each of the four deaths independently. The names of the deceased were not disclosed.

“We are stunned to learn of these deaths, and it has sent shockwaves of emotions throughout the department,” Sheriff Robert Luna said in a statement.

Richard Pippin, president of the Association for Los Angeles Deputy Sheriffs, told CNN he is “very confident” there was no correlation between the deceased members, who died between Monday morning and Tuesday morning.

A stressful job in a field struggling to fill the ranks

The deaths were unprecedented, with so many in a single agency in such a short time frame, begging the need for enhanced mental health resources and incentives for officers to recognize, seek and accept help when they need it, law enforcement experts said.

Pippin said the losses hit an agency dealing with low morale and severe staffing shortages.

The numbers are stark. On any given day, the department is short roughly 4,000 employees in an agency budgeted to have more than 17,000, according to a department budget report released earlier this year.

“With all the hiring the department has been able to do over six months, they were able to achieve a net gain of 15 employees. In other words, they’re just treading water. People are leaving as fast as they get hired,” Pippin said.

In some cases, officers are working up to 70 hours per week, Pippin said. “They aren’t seeing their families. It’s an arduous, stressful job,” he said.

The sheriff’s department in Los Angeles County isn’t alone. Police agencies nationwide have been struggling to fill and keep their ranks since the Covid-19 pandemic and the 2020 death of George Floyd, which sparked protests and scrutiny of law enforcement biases across the country.

From one call to the next, law enforcement officers meet people at the most difficult moments in their lives, he added.

“… And to deal with that, such a high percentage of your waking hours, week after week, and month after month, it’s wearing on them,” Pippin said.

Nine members of the department have died by suicide this year, a number far surpassing recent years: one in 2022, three in 2021 and two in 2020, Pippin said.

Police rarely seek help

The four suicides represent a “cluster,” a term tied to the phenomenon of suicide contagion, according to Dr. John Mann, a neuroscience professor at Columbia University and director of research and molecular imaging at the New York State Psychiatric Institute.

Clusters are proven to afflict close-knit groups, particularly those in uniform, when one act of suicide increases the risk others may attempt or die by suicide, said Mann.

Police serve in a profession afflicted with a 54% higher risk for suicide compared to the general US population, according to a study by John Violanti, research professor at University at Buffalo School of Public Health and Health Professions and an internationally known expert on police stress.

The resistance among police officers to speak out is rooted in the fear of how it will impact their jobs. “Because they know the department has liability concerns when it comes to sending a person out in public with a gun while knowing they’re experiencing emotional or psychological difficulties,” Pippin said.

It’s the result of the stigma around mental health ingrained in police culture, which perpetuates an attitude to “suck it up and move on,” according to Charles Ramsey, a CNN law enforcement analyst and former chief of the Metropolitan Police Department in Washington, DC.

Ramsey recalled witnessing the most gruesome scene in his 50-year career in law enforcement when he responded to a crime scene where five people had been murdered.

“To see something like that, it’s just not normal,” he said. “So, what do you do? You push it down. You suppress any emotion. But it doesn’t mean it’s not there, and if it goes untreated, over time, it builds up.”

As chief of the Philadelphia Police Department from 2008 to 2016, Ramsey implemented mandatory annual checkups with mental health professionals, and found officers voluntarily came back for second or third follow-up appointments.

“The ones that need it the most are the ones less likely to reach out and try to get help,” Ramsey said.

Looking for signs

A slight change in an officer’s behavior, appearance, mood and performance can be signs they might need support, according to Michael Harrison, former police commissioner in Baltimore and New Orleans, who enhanced officer wellness programs in both agencies.

“They’re already going through something emotionally mentally, spiritually, but we don’t want to have policies that then feel like we’re punishing them when they come to us and say I need help,” Harrison said.

Dr. Jeff Thompson, a research scientist at Columbia University Medical Center and a former NYPD hostage negotiator, cautioned it is “potentially dangerous” to reduce police suicides to a single cause.

“Inevitably, it’s stress combined with a psychiatric illness that is not treated,” said Mann, citing findings from studies of police suicides over the years.

So far this year, 86 police officers nationwide have died by suicide, according to the website Blue H.E.L.P., which tracks US officer suicides. But the number is underreported by at least 25% due to the stigma in police departments around reporting mental health issues, according to Karen Solomon, who cofounded the organization.

Everybody is scared to bring it up

Despite efforts to lessen the stigma, law enforcement officers still fear the consequences of raising mental health concerns to their superiors.

When Omar Delgado responded to the Pulse nightclub shooting, he saw the horrors where a gunman killed 49 people and wounded dozens of others. He spent hours inside Pulse with the dead as the standoff with the gunman continued.

The former suburban Eatonville Police Department officer was hailed as a hero by many for his actions, but haunted by the carnage, Delgado was not able to work for six months after the shooting and then returned to the force at a desk job.

By the end of 2017, Delgado lost his job at the department where he worked for nearly a decade because of his PTSD, he said. He said a doctor hired by the agency evaluated him as “unfit for duty.” CNN previously reported the department could neither confirm nor deny any further details, citing privacy regulations. He now works in private security.

“I became a poster child of PTSD because I reached out to my superiors and said, ‘Hey, I’m not feeling good. Something’s wrong. I need help,’” Delgado told CNN. “And it just went downhill from there.”

“I was constantly reliving that nightmare, seeing those bodies and I couldn’t stop. I couldn’t control my brain, my mind, to stop it from happening,” Delgado said.

It left him wondering about solutions to the stresses of his line of work.

“Is there a way to maybe slowly let the steam out of that pressure cooker, maybe quarterly, maybe yearly?” Delgado said. “I don’t know, because everybody is scared to bring it up. Nobody wants to get fired.”

If you or someone you know is struggling with feelings of depression or suicidal thoughts, the 988 Suicide & Crisis Lifeline offers free, round-the-clock support, information and resources for help. Call or text the lifeline at 988, or see the 988lifeline.org website, where chat is available.

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Seasonal affective disorder is a type of depression that occurs in late fall and winter that has to do with the lack of sunlight.

Having shorter days and longer nights during fall and winter can disrupt a 24-hour clock inside our bodies called the circadian rhythm. This clock regulates multiple bodily processes and is influenced by the day-night cycle, said circadian rhythm expert Joseph Takahashi, professor and chair of the neuroscience department at the University of Texas Southwestern Medical Center, via email. Disrupted circadian responses may affect brain regions involved in mood, along with causing fatigue and low energy from lack of sleep.

Taking care of your health is key to dealing with seasonal affective disorder. Here’s what experts say you can do to manage seasonal affective disorder. Remember to talk to your medical provider before starting any new treatments.

Try bright light therapy

Light therapy is the go-to treatment for seasonal affective disorder. It involves exposing yourself to a light box with at least 10,000 lux for at least 30 minutes. (Lux is a unit of measurement for light level intensity.)

“A bright sunny day is 50,000 to 100,000 lux,” said Dr. Jason Tucciarone, an instructor of psychiatry at Stanford University School of Medicine. While you can purchase a light box of lower intensity, you will have to spend more time sitting in front of it.

There are two ways a light box helps with seasonal affective disorder. First, mimicking outdoor light corrects the internal clock thrown out of sync from shorter days in winter. Another way is by increasing levels of serotonin, a brain chemical involved in balancing mood.

You can use the light box at any time, but morning use can give you more energy for the rest of the day. “Look away from it and do something where you’re sitting in front of the light, whether it’s eating breakfast, reading the news or anything that will keep you busy for 30 minutes,” Tucciarone said. Make sure to stay 2 to 3 feet away from it and do not look directly into the box because 10,000 lux can hurt your eyes.

Invest in a dawn simulator

These type of alarm clocks imitate natural sunlight. When it’s time to wake up, the light gradually increases in intensity.

Some research suggests dawn simulators may be just as effective in reducing depressive symptoms. They may be a good addition to your light box therapy, Tucciarone said, as you can get exposed to light the moment you wake up without straining your eyes.

Prioritize sleep at night

Thomas Kilkenny, a sleep specialist at Northwell Health in New York, emphasized the importance of getting enough sleep. The lack of sunlight from shorter winter days can disrupt our internal clocks that tell us when it’s time to be awake and when it’s time to wind down. The disrupted sleep schedule can cause insomnia and excessive daytime sleepiness.

Get ready for bed an hour before you plan to go, Kilkenny recommended. Dim the lights, use the bathroom and avoid arguments or emotional situations where you’re going to get yourself worked up. Additionally, avoid using electronics as you start to wind down as they can make it harder to fall asleep.

“Phones and computers have bright light which can trick your mind into thinking it’s daylight,” Tucciarone said.

Finally, he advised having a stable sleep schedule, which entails going to bed around the same time every night and waking up the same time every morning.

Go for a walk outside

Exercise works as a mood booster as it releases chemicals such as serotonin and endorphins to make you feel good and cope better with stress. Even a low-impact activity such as a 10-to-15 minute brisk walk can improve depressive symptoms.

Going outside for a small walk can be even more beneficial, Kilkenny said, since you are simultaneously exposing yourself to bright light.

If you are going to exercise, Kilkenny recommended doing it in the morning rather than at night. “Working out a couple of hours before bed will actually raise your body temperature, which is a bad idea,” he said.

Socialize with other people

Feeling an urge to hibernate for the winter? Social isolation is common among people with seasonal affective disorder, and isolating may contribute to depressive symptoms. Recently, the US surgeon general reported that being socially disconnected was as bad for your health as smoking 15 cigarettes a day.

“Socialization is really important in treating disorders in general,” Tucciarone said. “Isolating is not good for mood.” You may not feel up to a party or a dinner date, but even small amounts of companionship can make a difference. One suggestion from Tucciarone is having a buddy with you when taking outdoor walks.

Get medical attention

Cognitive behavioral therapy has people with seasonal affective disorder work to develop an awareness on what they’re experiencing, identify negative thoughts and come up with strategies to replace the thoughts with more positive ones, said Lucian Manu, a psychiatrist at Stony Brook Medicine in New York.

Antidepressants are another option that Manu recommended for people with severe seasonal affective disorder. Selective serotonin reuptake inhibitors, for example, work to boost serotonin levels, which can help boost mood. A popular prescription is bupropion, which Manu said helps in managing increasing sleep (along with appetite and weight) for people with seasonal affective disorder.

Jocelyn Solis-Moreira is a New York-based freelance health and science journalist.

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