The Chicken and Egg Problem of Fighting Another Flu Pandemic

Even a peep of news about a new flu pandemic is enough to set scientists clucking about eggs.

They worried about them in 2005, and in 2009, and they’re worrying now. That’s because millions of fertilized hen eggs are still the main ingredient in making vaccines that, hopefully, will protect people against the outbreak of a new flu strain.

“It’s almost comical to be using a 1940s technology for a 21st-century pandemic,” said Rick Bright, who led the Health and Human Services Department’s Biomedical Advanced Research and Development Authority (BARDA) during the Trump administration.

It’s not so funny, he said, when the currently stockpiled formulation against the H5N1 bird flu virus requires two shots and a whopping 90 micrograms of antigen, yet provides just middling immunity. “For the U.S. alone, it would take hens laying 900,000 eggs every single day for nine months,” Bright said.

And that’s only if the chickens don’t get infected.

The spread of an avian flu virus has decimated flocks of birds (and killed barn cats and other mammals). Cattle in at least nine states and at least three people in the U.S. have been infected, enough to bring public health attention once again to the potential for a global pandemic.

As of May 30, the only confirmed human cases of infection were dairy workers in Texas and Michigan, who experienced eye irritation. Two quickly recovered, while the third developed respiratory symptoms and was being treated with an antiviral drug at home. The virus’s spread into multiple species over a vast geographic area, however, raises the threat that further mutations could create a virus that spreads from human to human through airborne transmission.

If they do, prevention starts with the egg.

To make raw material for an influenza vaccine, virus is grown in millions of fertilized eggs. Sometimes it doesn’t grow well, or it mutates to a degree that the vaccine product stimulates antibodies that don’t neutralize the virus — or the wild virus mutates to an extent that the vaccine doesn’t work against it. And there’s always the frightening prospect that wild birds could carry the virus into the henhouses needed in vaccine production.

“Once those roosters and hens go down, you have no vaccine,” Bright said.

Since 2009, when an H1N1 swine flu pandemic swept around the world before vaccine production could get off the ground, researchers and governments have been looking for alternatives. Billions of dollars have been invested into vaccines produced in mammalian and insect cell lines that don’t pose the same risks as egg-based shots.

“Everyone knows the cell-based vaccines are better, more immunogenic, and offer better production,” said Amesh Adalja, an infectious disease specialist at Johns Hopkins University’s Center for Health Security. “But they are handicapped because of the clout of egg-based manufacturing.”

The companies that make the cell-based influenza vaccines, CSL Seqirus and Sanofi, also have billions invested in egg-based production lines that they aren’t eager to replace. And it’s hard to blame them, said Nicole Lurie, HHS’ assistant secretary for preparedness and response under President Barack Obama who is now an executive director of CEPI, the global epidemic-fighting nonprofit.

“Most vaccine companies that responded to an epidemic — Ebola, Zika, covid — ended up losing a lot of money on it,” Lurie said.

Exceptions were the mRNA vaccines created for covid, although even Pfizer and Moderna have had to destroy hundreds of millions of doses of unwanted vaccine as public interest waned.

Pfizer and Moderna are testing seasonal influenza vaccines made with mRNA, and the government is soliciting bids for mRNA pandemic flu vaccines, said David Boucher, director of infectious disease preparedness at HHS’ Administration for Strategic Preparedness and Response.

Bright, whose agency invested a billion dollars in a cell-based flu vaccine factory in Holly Springs, North Carolina, said there’s “no way in hell we can fight an H5N1 pandemic with an egg-based vaccine.” But for now, there’s little choice.

BARDA has stockpiled hundreds of thousands of doses of an H5N1-strain vaccine that stimulates the creation of antibodies that appear to neutralize the virus now circulating. It could produce millions more doses of the vaccine within weeks and up to 100 million doses in five months, Boucher told KFF Health News.

But the vaccines currently in the national stockpile are not a perfect match for the strain in question. Even with two shots containing six times as much vaccine substance as typical flu shots, the stockpiled vaccines were only partly effective against strains of the virus that circulated when those vaccines were made, Adalja said.

However, BARDA is currently supporting two clinical trials with a candidate vaccine virus that “is a good match for what we’ve found in cows,” Boucher said.

Flu vaccine makers are just starting to prepare this fall’s shots but, eventually, the federal government could request production be switched to a pandemic-targeted strain.

“We don’t have the capacity to do both,” Adalja said.

For now, ASPR has a stockpile of bulk pandemic vaccine and has identified manufacturing sites where 4.8 million doses could be bottled and finished without stopping production of seasonal flu vaccine, ASPR chief Dawn O’Connell said on May 22. U.S. officials began trying to diversify away from egg-based vaccines in 2005, when avian flu first gripped the world, and with added vigor after the 2009 fiasco. But “with the resources we have available, we get the best bang for our buck and best value to U.S. taxpayers when we leverage the seasonal infrastructure, and that’s still mostly egg-based,” Boucher said.

Flu vaccine companies “have a system that works well right now to accomplish their objectives in manufacturing the seasonal vaccine,” he said. And without a financial incentive, “we are going to be here with eggs for a while, I think.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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An Obscure Drug Discount Program Stifles Use of Federal Lifeline by Rural Hospitals

Facing ongoing concerns about rural hospital closures, Capitol Hill lawmakers have introduced a spate of proposals to fix a federal program created to keep lifesaving services in small towns nationwide.

In Anamosa, Iowa — a town of fewer than 6,000 residents located more than 900 miles from the nation’s capital — rural hospital leader Eric Briesemeister is watching for Congress’ next move. The 22-bed hospital Briesemeister runs averages about seven inpatients each night, and its most recent federal filings show it earned just $95,445 in annual net income from serving patients.

Yet Briesemeister isn’t interested in converting the facility into a rural emergency hospital, which would mean getting millions of extra dollars each year from federal payments. In exchange for that financial support, hospitals that join the program keep their emergency departments open and give up inpatient beds.

“It wasn’t for us,” said Briesemeister, chief executive of UnityPoint Health-Jones Regional Medical Center. “I think that program is a little bit more designed for hospitals that might not be around without it.”

Nationwide, only about two dozen of the more than 1,500 eligible hospitals have become rural emergency hospitals since the program launched last year. At the same time, rural hospitals continue to close — 10 since the fix became available.

Federal lawmakers have introduced a handful of legislative solutions since March. In one bill, senators from Kansas and Minnesota list a myriad of tactics, including allowing older closed facilities to reopen.

Another proposal introduced in the House by two Michigan lawmakers is the Rural 340B Access Act. It would allow rural emergency hospitals to use the 340B federal drug discount program, which Congress created in 1992.

The 340B program, named after its federal statute, lets eligible hospitals and clinics buy drugs at a discount and then bill insurance companies, Medicare, or Medicaid at market rates. Hospitals get to keep the money they make from the difference.

Congress approved 340B as an indirect aid package to help struggling hospitals stay afloat. Many larger hospitals say the cash is used for community benefits and charity care, while many small hospitals depend on the drug discounts to help cover staffing and operational shortfalls.

Currently, emergency hospitals are not eligible for 340B discounts. According to a release from U.S. Rep. Jack Bergman (R-Mich.), the House proposal would “correct this oversight.” Backers of the House bill include the American Hospital Association and the National Rural Health Association.

In Iowa, Briesemeister said the 340B federal drug discount program “can be used for tremendous good.” The small-town hospital uses money it makes from 340B to subsidize emergency services and uninsured and underinsured patients who frequent the emergency department, he said.

Chuck Grassley, Iowa’s longtime Republican senator, shepherded the Rural Emergency Hospital program into law. His spokesperson, Gillie Maddox, did not respond directly to questions about why the federal law creating rural emergency hospitals omitted the 340B program. Instead, Maddox said the designation was a “product of bipartisan negotiations.”

A survey conducted by the health analytics and consulting firm Chartis, along with the National Rural Health Association, found that nearly 80% of rural hospitals had participated in 340B and nearly 40% said they reaped $750,000 or more annually from the program.

Sanford Health, a largely rural health system headquartered in Sioux Falls, South Dakota, considered converting a handful of smaller critical access hospitals into rural emergency hospitals.

Martha Leclerc, vice president of corporate contracting for Sanford, said the system analyzed how much revenue would be lost by closing inpatient beds, which is also a requirement of the emergency hospital program, and by being unable to file for drug discounts.

In the end, she said, switching did not “make a lot of sense.”

While many rural hospitals are clamoring for the 340B provision to be added to the rural emergency hospital program, opponents have said 340B can be a cash cow for hospitals that don’t serve enough vulnerable patients.

Nicole Longo is deputy vice president of public affairs for the Pharmaceutical Research and Manufacturers of America, the nation’s largest, most influential pharmaceutical lobbying group. She wrote in a recent blog post that hospital systems and chain pharmacies are “exploiting the program” and said patients have not benefited from the growth in the program.

In an interview, Longo said PhRMA supports rural emergency hospitals being able to access 340B because they are treating “vulnerable patients in underserved communities” and are “true safety net providers.”

PhRMA, she said, wants to encourage a thoughtful conversation about “which types of hospitals should be in the program.” Last year, PhRMA formed an unlikely pact with community health centers to create the Alliance to Save America’s 340B Program, or ASAP 340B.

Vacheria Keys, associate vice president of policy and regulatory affairs at the National Association of Community Health Centers, said, “There is a new day of openness, from all parties.”

Use of the drug discount program skyrocketed after provisions in the Patient Protection and Affordable Care Act, passed in 2010, allowed hospitals and clinics to contract with an unlimited number of retail pharmacies, such as Walgreens and CVS, which are paid a fee to dispense the discounted drugs.

Adam J. Fein, president of the industry research organization Drug Channels Institute, reports that the 340B program is the second-largest federal drug program, trailing Medicare Part D. The flow of drugs purchased under the 340B program reached $53.7 billion in 2022, about $9.8 billion more than in 2021.

In response to the exploding use of contract pharmacies, pharmaceutical manufacturers have restricted the drugs they offer at a discount through the pharmacies. That throttling is affecting rural hospitals like Labette Health, a Kansas hospital whose president asked President Joe Biden for help in dealing with the pharmaceutical companies.

Rena Conti, an associate professor of markets, public policy, and law at Boston University’s Questrom School of Business, has studied the drug discounts for years and said she has “significant worries about expanding” the 340B program.

“There is a lot of money being generated in this program that we really can’t understand exactly how much that really is and exactly who it is benefiting,” Conti said.

At the same time, said Conti, a health care economist, giving rural hospitals access to the federal drug discounts “makes sense because they are hospitals that are serving particularly vulnerable patient populations.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Safety-Net Health Clinics Cut Services and Staff Amid Medicaid ‘Unwinding’

One of Montana’s largest health clinics that serves people in poverty has cut back services and laid off workers. The retrenchment mirrors similar cuts around the country as safety-net health centers feel the effects of states purging their Medicaid rolls.

Billings-based RiverStone Health is eliminating 42 jobs this spring, cutting nearly 10% of its workforce. The cuts have shuttered an inpatient hospice facility, will close a center for patients managing high blood pressure, and removed a nurse who worked within rural schools. It also reduced the size of the clinic’s behavioral health care team and the number of staffers focused on serving people without housing.

RiverStone Health CEO Jon Forte said clinic staffers had anticipated a shortfall as the cost of business climbed in recent years. But a $3.2 million loss in revenue, which he largely attributed to Montana officials disenrolling a high number of patients from Medicaid, pushed RiverStone’s deficit much further into the red than anticipated.

“That has just put us in a hole that we could not overcome,” Forte said.

RiverStone is one of nearly 1,400 federally funded clinics in the U.S. that adjust their fees based on what individuals can pay. They’re designed to reach people who face disproportionate barriers to care. Some are in rural communities, where offering primary care can come at a financial loss. Others concentrate on vulnerable populations falling through cracks in urban hubs. Altogether, these clinics serve more than 30 million people.

The health centers’ lifeblood is revenue received from Medicaid, the state-federal subsidized health coverage for people with low incomes or disabilities. Because they serve a higher proportion of low-income people, the federally funded centers tend to have a larger share of patients on the program and rely on those reimbursements.

But Medicaid enrollment is undergoing a seismic shift as states reevaluate who is eligible for it, a process known as the Medicaid “unwinding.” It follows a two-year freeze on disenrollments that protected people’s access to care during the covid public health emergency.

As of May 23, more than 22 million people had lost coverage, including about 134,000 in Montana — 12% of the state’s population. Some no longer met income eligibility requirements, but the vast majority were booted because of paperwork problems, such as people missing the deadline, state documents going to outdated addresses, or system errors.

That means health centers increasingly offer care without pay. Some have seen patient volumes drop, which also means less money. When providers like RiverStone cut services, vulnerable patients have fewer care options.

Jon Ebelt, communications director of the Montana Department of Public Health and Human Services, said the agency isn’t responsible for individual organizations’ business decisions. He said the state is focused on maintaining safety-net systems while protecting Medicaid from being misused.

Nationwide, health centers face a similar problem: a perfect financial storm created by a sharp rise in the cost of care, a tight workforce, and now fewer insured patients. In recent months, clinics in California and Colorado have also announced cuts.

“It’s happening in all corners of the country,” said Amanda Pears Kelly, CEO of Advocates for Community Health, a national advocacy group representing federally qualified health centers.

Nearly a quarter of community health center patients who rely on Medicaid were cut from the program, according to a joint survey from George Washington University and the National Association of Community Health Centers. On average, each center lost about $600,000.

One in 10 centers either reduced staff or services, or limited appointments.

“Health centers across the board try to make sure that the patients know they’re still there,” said Joe Dunn, senior vice president for public policy and advocacy at the National Association of Community Health Centers.

Most centers operate on shoestring budgets, and some started reporting losses as the workforce tightened and the cost of business spiked.

Meanwhile, federal assistance — money designed to cover the cost of people who can’t afford care —remained largely flat. Congress increased those funds in March to roughly $7 billion over 15 months, though health center advocates said that still doesn’t cover the tab.

Until recently, RiverStone in Montana had been financially stable. Before the pandemic, the organization was making money, according to financial audits.

In summer 2019, a $10 million expansion was starting to pay off. RiverStone was serving more patients through its clinic and pharmacy, a revenue increase that more than offset increases in operating costs, according to documents.

But in 2021, at the height of the pandemic, those growing expenses — staff pay, building upkeep, the price of medicine, and medical gear — outpaced the cash coming in. By last summer, the company had an operational loss of about $1.7 million. With the Medicaid redetermination underway, RiverStone’s pool of covered patients shrank, eroding its financial buffer.

Forte said the health center plans to ask state officials to increase its Medicaid reimbursement rates, saying existing rates don’t cover the continuum of care. That’s a tricky request after the state raised its rates slightly last year following much debate around which services needed more money.

Some health center cuts represent a return to pre-pandemic staffing, after temporary federal pandemic funding dried up. But others are rolling back long-standing programs as budgets went from stretched to operating in the red.

California’s Petaluma Health Center in March laid off 32 people hired during the pandemic, The Press Democrat reported, or about 5% of its workforce. It’s one of the largest primary care providers in Sonoma County, where life expectancy varies based on where people live and poverty is more prevalent in largely Hispanic neighborhoods.

Clinica Family Health, which has clinics throughout Colorado’s Front Range, laid off 46 people, or about 8% of its staff, in October. It has consolidated its dental program from three clinics to two, closed a walk-in clinic meant to help people avoid the emergency room, and ended a home-visit program for patients recently discharged from the hospital.

Clinica said 37% of its patients on Medicaid before the unwinding began lost their coverage and are now on Clinica’s discount program. This means the clinic now receives between $5 and $25 for medical visits that used to bring in $220-$230.

“If it’s a game of musical chairs, we’re the ones with the last chair. And if we have to pull it away, then people hit the ground,” said CEO Simon Smith.

Stephanie Brooks, policy director of the Colorado Community Health Network, which represents Colorado health centers, said some centers are considering consolidating or closing clinics.

Colorado and Montana have among the nation’s highest percentages of enrollment declines. Officials in both states have defended their Medicaid redetermination process, saying most people dropped from coverage likely no longer qualify, and they point to low unemployment rates as a factor.

In many states, health providers and patients alike have provided examples in which people cut from coverage still qualified and had to spend months entangled in system issues to regain access.

Forte, with RiverStone, said reducing services on the heels of a pandemic adds insult to injury, both for health care workers who stayed in hard jobs and for patients who lost trust that they’ll be able to access care.

“This is so counterproductive and counterintuitive to what we’re trying to do to meet the health care needs of our community,” Forte said.

KFF Health News correspondent Rae Ellen Bichell in Longmont, Colorado, contributed to this report.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Tennessee Gives This Hospital Monopoly an A Grade — Even When It Reports Failure

A Tennessee agency that is supposed to hold accountable and grade the nation’s largest state-sanctioned hospital monopoly awards full credit on dozens of quality-of-care measurements as long as it reports any value — regardless of how its hospitals actually perform.

Ballad Health, a 20-hospital system in northeast Tennessee and southwest Virginia, has received A grades and an annual stamp of approval from the Tennessee Department of Health. This has occurred as Ballad hospitals consistently fall short of performance targets established by the state, according to health department documents.

Because the state’s scoring rubric largely ignores the hospitals’ performance, only 5% of Ballad’s final score is based on actual quality of care, and Ballad has suffered no penalty for failing to meet the state’s goals in about 50 areas — including surgery complications, emergency room speed, and patient satisfaction.

“It doesn’t make any sense,” said Ron Allgood, 75, of Kingsport, Tennessee, who said he had a heart attack in a Ballad ER in 2022 after waiting for three hours with chest pains. “It seems that nobody listens to the patients.”

Ballad Health was created six years ago after Tennessee and Virginia lawmakers waived federal anti-monopoly laws so two competing hospital companies could merge. The monopoly agreement established two quality measures to compare Ballad’s care against the state’s baseline expectations: about 17 “target” measures, on which hospitals are expected to improve and their performance factors into their grade; and more than 50 “monitoring” measures, which Ballad must report, but how the hospitals perform on them is not factored into Ballad’s grade.

Ballad has failed to meet the baseline values on 75% or more of all quality measures in recent years — and some are not even close — according to reports the company has submitted to the health department.

Since the merger, Ballad has become the only option for hospital care for most of about 1.1 million residents in a 29-county region at the nexus of Tennessee, Virginia, Kentucky, and North Carolina. Critics are vocal. Protesters rallied outside a Ballad hospital for months. For years, longtime residents like Allgood have alleged Ballad’s leadership has diminished the hospitals they’ve relied on their entire lives.

“It’s a shadow of the hospital we used to have,” Allgood said.

And yet, every year since the merger, the Tennessee health department has reported that the benefits of the hospital merger outweigh the risks of a monopoly, and that Ballad “continues to provide a Public Advantage.” Tennessee has also given Ballad an A grade in every year but two, when the scoring system was suspended due to the covid-19 pandemic and no grade issued.

The department’s latest report, released this month, awarded Ballad 93.6 of 100 possible points, including 15 points just for reporting the monitoring measures. If Tennessee rescored Ballad based on its performance, its score would drop from 93.6 to about 79.7, based on the scoring rubric described in health department documents. Tennessee considers scores of 85 or higher to be “satisfactory,” the documents state.

Larry Fitzgerald, who monitored Ballad for the Tennessee government before retiring this year, said it was obvious the state’s scoring rubric should be changed.

Fitzgerald likened Ballad to a student getting 15 free points on a test for writing any answer.

“Do I think Ballad should be required to show improvement on those measures? Yes, absolutely,” Fitzgerald said. “I think any human being you spoke with would give the same answer.”

Ballad Health declined to comment. Tennessee Department of Health spokesperson Dean Flener declined an interview request and directed all questions about Ballad to the Tennessee Attorney General’s Office, which also has a role in regulating the monopoly. Amy Wilhite, a spokesperson for the AG’s office, directed those questions back to the health department and provided documents showing it is the agency responsible for how Ballad is scored.

The Virginia Department of Health, which is also supposed to perform “active supervision” of Ballad as part of the monopoly agreement, has fallen several years behind schedule. Its most recent assessment of the company was for fiscal year 2020, when it found that the benefits of the monopoly “outweigh the disadvantages.” Erik Bodin, a Virginia official who oversees the agreement, said more recent reports are not yet ready to be released.

Ballad Health was formed in 2018 after state officials approved the nation’s biggest so-called Certificate of Public Advantage, or COPA, agreement, allowing a merger of the Tri-Cities region’s only two hospital systems — Mountain States Health Alliance and Wellmont Health System. Nationwide, COPAs have been used in about 10 hospital mergers over the past three decades, but none has involved as many hospitals as Ballad’s.

The Federal Trade Commission has warned that hospital monopolies lead to increased prices and decreased quality of care. To offset the perils of Ballad’s monopoly, officials required the new company to agree to more robust regulation by state health officials and a long list of special conditions, including the state’s quality-of-care measurements.

Ballad failed to meet the baseline on about 80% of those quality measures from July 2021 to June 2022, according to a report the company submitted to the health department. The following year, Ballad fell short on about 75% of the quality measures, and some got dramatically worse, another company report shows.

For example, the median time Ballad patients spend in the ER before being admitted to the hospital has risen each year and is now nearly 11 hours, according to the latest Ballad report. That’s more than three times what it was when the monopoly began, and more than 2.5 times the state baseline.

And yet Ballad’s grade is not lowered by the lack of speed in its ERs.

Fitzgerald, Tennessee’s former Ballad monitor, who previously served as an executive in the University of Virginia Health System, said a hospital company with competitors would have more reason than Ballad to improve its ER speeds.

“When I was at UVA, we monitored this stuff passionately because — and I think this is the key point here — we had competition,” Fitzgerald said. “And if we didn’t score well, the competition took advantage.”

Midwest correspondent Samantha Liss contributed to this report.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Florida es el primer estado en permitir que se realicen cesáreas fuera de hospitales

Florida se ha convertido en el primer estado en permitir que los obstetras realicen cesáreas fuera de los hospitales, apoyando a un grupo médico de un consorcio privado que afirma que el cambio reducirá costos y brindará a las mujeres embarazadas un ambiente de parto más hogareño, que muchas desean.

Pero la industria hospitalaria y la principal asociación de obstetras del país dicen que, aunque algunos hospitales de Florida han cerrado sus salas de maternidad en los últimos años, realizar cesáreas en clínicas dirigidas por médicos aumentará los riesgos para las mujeres y los bebés si surgen complicaciones.

“Una paciente embarazada que se considera de bajo riesgo en un momento puede necesitar atención que le salve la vida al siguiente”, dijo Cole Greves, perinatólogo de Orlando que preside la sección de Florida del Colegio Americano de Obstetras y Ginecólogos, en un correo electrónico a KFF Health News.

Las nuevas clínicas de parto, “incluso con una mayor regulación, no pueden garantizar el nivel de seguridad que los pacientes tendrían en un hospital”, agregó.

Esta primavera, se promulgó una ley que permite los “centros de parto avanzados”, donde los médicos pueden asistir partos vaginales o por cesárea en mujeres consideradas de bajo riesgo de sufrir complicaciones. Las mujeres podrían quedarse a pasar la noche en las clínicas.

Women’s Care Enterprises, un grupo médico propiedad de una firma de capital privado con centros principalmente en Florida, pero también en California y Kentucky, presionó a la Legislatura estatal para realizar el cambio.

BC Partners, una firma de inversión con sede en Londres, compró Women’s Care en 2020.

“Tenemos pacientes que no quieren dar a luz en un hospital, y eso nos rompe el corazón”, dijo Stephen Snow, quien recientemente se jubiló como obstetra-ginecólogo en Women’s Care y testificó ante la Legislatura de Florida abogando por el cambio en 2018.

Brittany Miller, vicepresidenta de iniciativas estratégicas de Women’s Care, dijo que el grupo no comentaría sobre el tema.

Expertos en salud son cautelosos.

“Lo que esto parece es un pobre sustituto de una atención obstétrica de calidad, efectivamente presentada como algo que ofrece más opciones a las personas”, dijo Alice Abernathy, profesora asistente de obstetricia y ginecología en la Facultad de Medicina Perelman de la Universidad de Pennsylvania. “Esto se siente como una mala solución a un problema crónico que empeorará los resultados en lugar de mejorarlos”, dijo Abernathy.

Casi un tercio de los nacimientos en Estados Unidos ocurren por cesárea, el parto quirúrgico de un bebé a través de una incisión en el abdomen y el útero de la madre. Generalmente, los médicos utilizan el procedimiento cuando creen que es más seguro que el parto vaginal para la madre, el bebé, o ambos.

Estas decisiones médicas pueden tomarse meses antes del parto, o en una emergencia.

La senadora estatal de Florida Gayle Harrell, la republicana que patrocinó el proyecto de ley de centros de parto, dijo que tener una cesárea fuera de un hospital puede parecer un cambio radical, pero también lo fue la apertura de centros de cirugía ambulatoria a finales de la década de 1980.

Harrell, quien gestionó el consultorio de obstetricia y ginecología de su esposo, dijo que los centros de parto tendrán que cumplir con los mismos altos estándares para personal, control de infecciones y otros aspectos como los centros de cirugía ambulatoria.

“Dado el grado de necesidad, y los desiertos de maternidad en todo el estado, esto es algo que nos ayudará y ayudará a las madres a recibir la mejor atención”, completó.

Desde 2019, 17 hospitales en el estado han cerrado sus unidades de maternidad, muchos citando bajos reembolsos por parte de los seguros y altos costos por casos de negligencia médica, según la Asociación de Hospitales de Florida. Mary Mayhew, directora ejecutiva de la asociación, dijo que es incorrecto comparar los centros de parto con los centros de cirugía ambulatoria debido a los muchos riesgos asociados con las cesáreas, como las hemorragias.

La ley de Florida requiere que los centros de parto avanzados tengan un acuerdo de transferencia con un hospital, pero no dicta dónde pueden abrir las instalaciones ni su proximidad a un hospital.

“Tenemos serias preocupaciones sobre el impacto que este modelo tiene en nuestros esfuerzos colectivos para mejorar la salud materno infantil”, dijo Mayhew. “Nuestros hospitales no ven que esto sea en el mejor interés de proporcionar calidad y seguridad en el trabajo de parto y el parto”.

A pesar de su oposición a los nuevos centros de parto, la Asociación de Hospitales de Florida no se opuso a la aprobación del proyecto de ley en general porque también incluyó un aumento importante en la cantidad que Medicaid paga a los hospitales por la atención de maternidad.

Mayhew dijo que es poco probable que los centros de parto ayuden a abordar la escasez de atención.

Los hospitales ya están luchando con una escasez de gineco-obstetras, dijo, y es poco realista esperar que los centros de parto avanzados se abran en áreas rurales con una gran proporción de personas en Medicaid, que paga el reembolso más bajo por la atención de parto.

No está claro si las aseguradoras cubrirán los centros de parto avanzados, aunque la mayoría de las aseguradoras y Medicaid cubren la atención en centros de parto dirigidos por parteras.

Los centros de parto avanzados no aceptarán emergencias, y tratarán solo a pacientes cuyo seguro tenga contratos con las instalaciones, haciéndolos parte de la red.

Snow, el gineco-obstetra retirado de Women’s Care, dijo que el grupo planea abrir un centro de parto avanzado en el área de Tampa u Orlando. Dijo que este concepto es una mejora en la atención de parteras que permite partos fuera de los hospitales ya que los centros permiten que las mujeres se queden a pasar la noche y, si es necesario, ofrecen anestesia y cesáreas.

Snow reconoció que, con una firma de capital privado invirtiendo en Women’s Care, la idea del centro de parto también se trata de ganar dinero. Pero dijo que los hospitales tienen el mismo incentivo de lucro y, al igual que las parteras, probablemente se oponen a la idea de centros que pueden realizar cesáreas porque podrían afectar los ingresos del hospital.

“Estamos tratando de reducir el costo de la medicina, y esto sería más rentable y más agradable para los pacientes”, opinó.

Kate Bauer, directora ejecutiva de la Asociación Americana de Centros de Parto, dijo que los pacientes podrían confundir los centros de parto avanzados con los centros de parto independientes existentes para partos de bajo riesgo que han sido dirigidos por parteras durante décadas.

Actualmente hay 31 centros de parto con licencia en Florida y 411 centros de parto independientes en Estados Unidos, dijo. “Esto es un cambio radical con respecto al estándar de atención”, dijo Bauer. “Es una mala idea”, agregó, porque podría aumentar los riesgos para la madre y el bebé.

Ningún otro estado permite cesáreas fuera de los hospitales. La única instalación que ofrece una atención similar es una clínica de partos en Wichita, Kansas, que está conectada por un corto pasillo a un hospital, el Wesley Medical Center. La clínica ofrece suites de maternidad “tipo hotel” donde el personal atiende alrededor de 100 nacimientos al mes, en comparación con 500 al mes en el hospital.

Morgan Tracy, una navegadora de enfermería de maternidad en el centro, dijo que el concepto funciona en gran medida porque el hospital y las suites de maternidad pueden compartir personal y acceso a la farmacia, además que los pacientes pueden ser trasladados rápidamente al hospital principal si surgen complicaciones.

“La belleza es que hay miembros del equipo a ambos lados de la calle”, dijo Tracy.

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La vacuna contra el sarampión es segura y eficaz. No te dejes engañar por los escépticos

Los casos de sarampión están aumentando en Estados Unidos. En el primer trimestre de este año, se registró un número de casos 17 veces mayor con respecto al promedio registrado durante el mismo período en los cuatro años anteriores, según los Centros para el Control y Prevención de Enfermedades (CDC). La mitad de las personas infectadas, principalmente niños, han sido hospitalizadas.

Y se espera que las cifras sigan empeorando, en gran medida porque cada vez más padres deciden no vacunar a sus hijos contra el sarampión y otras enfermedades como la polio y la tos ferina.

Este año, el 80% de los casos ha sido en personas no vacunadas o con un estatus de vacunación desconocido. Muchos padres han sido influenciados por una avalancha de desinformación difundida por políticos y personalidades en redes sociales, podcasts, y en la TV, que repiten falsas creencias, erosionando la confianza en la ciencia que respalda las vacunas infantiles de rutina.

A continuación, examinamos algunos mitos frecuentes de la retórica antivacunas y explicamos por qué está equivocada:

“No es para tanto”

Una idea errónea común es que las vacunas no son necesarias porque las enfermedades que previenen no son peligrosas u ocurren con muy poca frecuencia como para ser motivo de preocupación. Aunque se hayan reportado casos de sarampión en 19 estados, los escépticos acusan a funcionarios de salud pública y a los medios de comunicación de sembrar temor sobre la enfermedad sin fundamento.

Por ejemplo, una nota publicada en el sitio web del National Vaccine Information Center, una fuente habitual de desinformación sobre las vacunas, sostuvo que la preocupación creciente por el sarampión “es una exageración al estilo de ‘el cielo se cae'”. El artículo decía que contraer el sarampión, las paperas, la varicela y la gripe (también llamada influenza) era “políticamente incorrecto”.

Según los CDC, el sarampión resulta fatal en aproximadamente 2 de cada 1,000 niños infectados. Si este nivel de riesgo suena aceptable, vale la pena señalar que un número mucho mayor de niños con sarampión requieren hospitalización por neumonía y otras complicaciones serias.

Por cada 10 casos de sarampión, un niño con la enfermedad desarrolla una infección de oído que puede causar la pérdida auditiva permanente. Otro efecto extraño del virus es que puede destruir la inmunidad de una persona, y así afectar su capacidad para recuperarse de la gripe y otras afecciones comunes.

Las vacunas contra el sarampión han evitado la muerte de alrededor de 94 millones de personas, principalmente niños, en los últimos 50 años, según un análisis de abril de la Organización Mundial de la Salud (OMS). Junto con las vacunas contra la polio y otras enfermedades, se estima que las vacunas han salvado 154 millones de vidas en todo el mundo.

Algunos escépticos de las vacunas sostienen que las enfermedades que previenen ya no son una amenaza porque se han vuelto relativamente poco frecuentes en el país. (Lo cual es cierto, gracias a la vacunación). Es el razonamiento que invocó el cirujano general de Florida, Joseph Ladapo, durante un brote de sarampión en febrero, cuando dijo a los padres que sus hijos no vacunados podían seguir yendo a la escuela. “Hay mucha inmunidad”, dijo Ladapo.

A medida que esta actitud relajada hacia las vacunas convence a los padres de no dárselas a sus hijos, la inmunidad colectiva disminuye y los brotes serán cada vez más grandes y se propagarán más rápido.

En 2019, un brote de rápido crecimiento afectó a una comunidad con tasas de vacunación insuficientes en Samoa y mató a 83 personas en cuatro meses. Las tasas persistentemente bajas de vacunación contra el sarampión en la República Democrática del Congo mataron a más de 5,600 personas a causa de la enfermedad en brotes masivos el año pasado.

“Nunca se sabe”

Desde los orígenes de las vacunas, siempre ha existido un grupo que ha desconfiado porque no son naturales, en comparación con las infecciones y plagas que abundan en la naturaleza. Los miedos y dudas sobre las vacunas han ido cambiando a lo largo de las décadas. En el 1800, por ejemplo, los escépticos pensaban que las vacunas contra la viruela hacían que a las personas les salieran cuernos y que se comportaran como bestias.

En tiempos más recientes, los escépticos han vinculado las vacunas con una variedad de afecciones, desde el trastorno por déficit de atención e hiperactividad hasta el autismo y las enfermedades del sistema inmunológico. Los estudios científicos no respaldan estas afirmaciones.

La realidad es que las vacunas están entre las intervenciones médicas más estudiadas. En el siglo pasado, las vacunas han pasado por estudios científicos y ensayos clínicos masivos tanto en las fases de desarrollo como después, durante su uso generalizado.

Más de 12,000 personas participaron en los ensayos clínicos de la última vacuna aprobada para prevenir el sarampión, las paperas y la rubéola. Al probar la vacuna en un gran número de personas, los investigadores pueden detectar riesgos poco comunes, lo cual es importante porque se administran a millones de personas sanas.

Para evaluar los riesgos a largo plazo, los científicos analizan grandes cantidades de datos para identificar señales de daño. Por ejemplo, un grupo danés analizó una base de datos de más de 657,000 niños y encontró que aquellos que fueron vacunados contra el sarampión cuando eran bebés no tenían más probabilidades de ser diagnosticados con autismo que aquellos que no fueron vacunados.

En otro estudio, los investigadores analizaron registros de 805,000 niños nacidos entre 1990 y 2001 y no encontraron ninguna prueba de que las vacunaciones múltiples pudieran afectar el sistema inmune de los niños.

Pero las personas que promueven la desinformación sobre las vacunas, como el candidato a la presidencia Robert F. Kennedy Jr., descartan los estudios masivos respaldados por la ciencia.

Por ejemplo, Kennedy sostiene que los ensayos clínicos para las nuevas vacunas no son confiables porque no se compara a los niños vacunados con un grupo que recibe un placebo, como solución salina u otra sustancia sin efecto. En vez de utilizar un placebo, muchos ensayos modernos comparan las vacunas actualizadas con otras más antiguas. Esto se debe a que se considera no ético poner en peligro a los niños al darles una vacuna falsa cuando se conoce el efecto protector de la inmunización.

En un ensayo clínico de vacunas contra la polio realizado en la década de 1950, 16 niños que recibieron un placebo murieron de polio y 34 quedaron paralizados, dijo Paul Offit, director del Centro de Educación Sobre Vacunas del Hospital de Niños de Philadelphia y autor de un libro sobre la primera vacuna contra la polio.

“Demasiadas y demasiado pronto”

Varios de los libros sobre vacunas más vendidos en Amazon promueven la peligrosa idea de que los padres deberían omitir o retrasar la vacunación de sus hijos. “Puede ser que no todas las vacunas en el calendario de los CDC sean adecuadas para todos los niños en todo momento”, escribe Paul Thomas en su libro más vendido “The Vaccine-Friendly Plan”. Para respaldar su argumento, dice que los niños que han seguido “mi protocolo están entre los más sanos del mundo”.

Desde la publicación del libro, la licencia médica de Thomas fue suspendida temporalmente en Oregon y Washington.

La Junta Médica de Oregon documentó cómo Thomas convenció a los padres a omitir vacunas recomendadas por los CDC e “hizo llorar” a una madre que no estaba de acuerdo. Varios niños bajo su cuidado contrajeron tos ferina y rotavirus, ambas enfermedades que se previenen fácilmente con vacunas, escribió la junta.

Thomas le recetó suplementos de aceite de pescado y homeopatía a un niño que tenía una laceración profunda en el cuero cabelludo en lugar de darle una vacuna de emergencia contra el tétanos. El niño desarrolló un cuadro de tétanos grave y estuvo en el hospital por casi dos meses, donde tuvo que someterse a una intubación, una traqueotomía y una sonda de alimentación para sobrevivir.

El calendario de vacunación recomendado por los CDC se diseñó para proteger a los niños en los momentos más vulnerables de su vida y minimizar los efectos secundarios. Por ejemplo, la vacuna combinada contra el sarampión, las paperas y la rubéola no se administra durante el primer año de vida del bebé porque los anticuerpos que transmite temporalmente la madre pueden interferir con la respuesta inmunitaria. Y como algunos bebés no generan una respuesta inmunitaria fuerte con esa primera dosis, los CDC recomiendan una segunda dosis alrededor del momento en que los niños comiencen el jardín de infantes, ya que el sarampión y otros virus se propagan rápidamente en contextos grupales.

No se recomienda retrasar mucho más las dosis de esta vacuna ya que los datos sugieren que los niños vacunados a los 10 años o más tienen más probabilidades de desarrollar reacciones adversas, como convulsiones o fatiga.

Alrededor de una docena de otras vacunas siguen su propio esquema cronológico, con superposiciones para obtener la mejor respuesta. Los estudios han demostrado que la vacuna contra el sarampión, las paperas y la rubéola se puede administrar de forma segura y eficaz combinada con otras vacunas.

“Ellos no quieren que lo sepas”

En la introducción del nuevo libro de Ladapo sobre cómo superar el miedo en la salud pública, Kennedy compara al cirujano general de Florida con Galileo. Así como la Inquisición católica condenó al famoso astrónomo por promover teorías sobre el universo, sugiere Kennedy, las instituciones científicas reprimen a los disidentes de las vacunas por razones nefastas.

“La persecución de científicos y médicos que se atreven a cuestionar las doctrinas contemporáneas no es nada nuevo”, escribe Kennedy. Su compañera de fórmula, la abogada Nicole Shanahan, ha hecho campaña con la idea de que las conversaciones sobre los peligros de las vacunas se están censurando y que las corporaciones influyen sobre los CDC y otras agencias federales para ocultar datos.

En el podcast más escuchado en Estados Unidos, “The Joe Rogan Experience”, a menudo figuran invitados que desconfían del consenso científico. El año pasado, en el programa, Kennedy repitió el mito muchas veces desmentido de que las vacunas causan autismo.

Lejos de ignorar ese miedo, los epidemiólogos lo han tomado en serio. Han realizado más de una docena de estudios en busca de un vínculo entre las vacunas y el autismo, y no han encontrado ninguno. “Hemos refutado de manera concluyente la teoría de que las vacunas están relacionadas con el autismo”, afirmó Gideon Meyerowitz-Katz, epidemiólogo de la Universidad de Wollongong en Australia. “Es por esto que el sistema de salud pública tiende a cerrar esas conversaciones rápidamente”.

Las agencias federales son transparentes con respecto a las reacciones que pueden causar las vacunas, incluyendo convulsiones y dolor en el brazo. Y el gobierno tiene un programa para compensar a las personas si se determina científicamente que sus lesiones son el resultado de las vacunas. Alrededor de 1 a 3.5 de cada millón de dosis de la vacuna contra el sarampión, las paperas y la rubéola pueden provocar una reacción alérgica potencialmente mortal. Se estima que el riesgo de muerte a causa de un rayo durante toda la vida de una persona es hasta cuatro veces mayor.

“Lo más convincente que puedo decir es que mi hija tiene todas sus vacunas y que todos los pediatras y profesionales de salud pública que conozco han vacunado a sus hijos”, dijo Meyerowitz-Katz. “Nadie haría eso si pensara que existen riesgos graves”.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Florida Allows Doctors To Perform C-Sections Outside of Hospitals

Florida has become the first state to allow doctors to perform cesarean sections outside of hospitals, siding with a private equity-owned physicians group that says the change will lower costs and give pregnant women the homier birthing atmosphere that many desire.

But the hospital industry and the nation’s leading obstetricians’ association say that even though some Florida hospitals have closed their maternity wards in recent years, performing C-sections in doctor-run clinics will increase the risks for women and babies when complications arise.

“A pregnant patient that is considered low-risk in one moment can suddenly need lifesaving care in the next,” Cole Greves, an Orlando perinatologist who chairs the Florida chapter of the American College of Obstetricians and Gynecologists, said in an email to KFF Health News. The new birth clinics, “even with increased regulation, cannot guarantee the level of safety patients would receive within a hospital.”

This spring, a law was enacted allowing “advanced birth centers,” where physicians can deliver babies vaginally or by C-section to women deemed at low risk of complications. Women would be able to stay overnight at the clinics.

Women’s Care Enterprises, a private equity-owned physicians group with locations mostly in Florida along with California and Kentucky, lobbied the state legislature to make the change. BC Partners, a London-based investment firm, bought Women’s Care in 2020.

“We have patients who don’t want to deliver in a hospital, and that breaks our heart,” said Stephen Snow, who recently retired as an OB-GYN with Women’s Care and testified before the Florida Legislature advocating for the change in 2018.

Brittany Miller, vice president of strategic initiatives with Women’s Care, said the group would not comment on the issue.

Health experts are leery.

“What this looks like is a poor substitute for quality obstetrical care effectively being billed as something that gives people more choices,” said Alice Abernathy, an assistant professor of obstetrics and gynecology at the University of Pennsylvania Perelman School of Medicine. “This feels like a bad band-aid on a chronic issue that will make outcomes worse rather than better,” Abernathy said.

Nearly one-third of U.S. births occur via C-section, the surgical delivery of a baby through an incision in the mother’s abdomen and uterus. Generally, doctors use the procedure when they believe it is safer than vaginal delivery for the parent, the baby, or both. Such medical decisions can take place months before birth, or in an emergency.

Florida state Sen. Gayle Harrell, the Republican who sponsored the birth center bill, said having a C-section outside of a hospital may seem like a radical change, but so was the opening of outpatient surgery centers in the late 1980s.

Harrell, who managed her husband’s OB-GYN practice, said birth centers will have to meet the same high standards for staffing, infection control, and other aspects as those at outpatient surgery centers.

“Given where we are with the need, and maternity deserts across the state, this is something that will help us and help moms get the best care,” she said.

Seventeen hospitals in the state have closed their maternity units since 2019, with many citing low insurance reimbursement and high malpractice costs, according to the Florida Hospital Association.

Mary Mayhew, CEO of the Florida Hospital Association, said it is wrong to compare birth centers to ambulatory surgery centers because of the many risks associated with C-sections, such as hemorrhaging.

The Florida law requires advanced birth centers to have a transfer agreement with a hospital, but it does not dictate where the facilities can open nor their proximity to a hospital.

“We have serious concerns about the impact this model has on our collective efforts to improve maternal and infant health,” Mayhew said. “Our hospitals do not see this in the best interest of providing quality and safety in labor and delivery.”

Despite its opposition to the new birth centers, the Florida Hospital Association did not fight passage of the overall bill because it also included a major increase in the amount Medicaid pays hospitals for maternity care.

Mayhew said it is unlikely that the birth centers would help address care shortages. Hospitals are already struggling with a shortage of OB-GYNs, she said, and it is unrealistic to expect advanced birth centers to open in rural areas with a large proportion of people on Medicaid, which pays the lowest reimbursement for labor and delivery care.

It is unclear whether insurers will cover the advanced birth centers, though most insurers and Medicaid cover care at midwife-run birth centers. The advanced birth centers will not accept emergency walk-ins and will treat only patients whose insurance contracts with the facilities, making them in-network.

Snow, the retired OB-GYN with Women’s Care, said the group plans to open an advanced birth center in the Tampa or Orlando area.

The advanced birth center concept is an improvement on midwife care that enables deliveries outside of hospitals, he said, as the centers allow women to stay overnight and, if necessary, offer anesthesia and C-sections.

Snow acknowledged that, with a private equity firm invested in Women’s Care, the birth center idea is also about making money. But he said hospitals have the same profit incentive and, like midwives, likely oppose the idea of centers that can provide C-sections because they could cut into hospital revenue.

“We are trying to reduce the cost of medicine, and this would be more cost-effective and more pleasant for patients,” he said.

Kate Bauer, executive director of the American Association of Birth Centers, said patients could confuse advanced birth centers with the existing, free-standing birth centers for low-risk births that have been run by midwives for decades. There are currently 31 licensed birth centers in Florida and 411 free-standing birth centers in the United States, she said.

“This is a radical departure from the standard of care,” Bauer said. “It’s a bad idea,” she said, because it could increase risks to mom and baby.

No other state allows C-sections outside of hospitals. The only facility that offers similar care is a birth clinic in Wichita, Kansas, which is connected by a short walkway to a hospital, Wesley Medical Center.

The clinic provides “hotel-like” maternity suites where staffers deliver about 100 babies a month, compared with 500 per month in the hospital itself.

Morgan Tracy, a maternity nurse navigator at the center, said the concept works largely because the hospital and birthing suites can share staff and pharmacy access, plus patients can be quickly transferred to the main hospital if complications arise.

“The beauty is there are team members on both sides of the street,” Tracy said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Reclaman revisar viejas restricciones que previenen que hombres gay y bisexuales donen tejidos

En 2020 y 2023, el gobierno federal cambió su postura sobre quiénes podían donar órganos y sangre de manera segura, reduciendo las restricciones para hombres que tienen sexo con hombres.

Pero las limitaciones que impone la Administración de Drogas y Alimentos (FDA) sobre la donación de tejidos, un término general que abarca desde los ojos hasta la piel y los ligamentos, siguen vigentes.

Defensores, legisladores y grupos enfocados en eliminar estas barreras, en particular la de la donación de córneas, dijeron sentirse frustrados porque la FDA no ha escuchado sus pedidos.

Lo que piden es que las pautas para los tejidos donados por hombres gays y bisexuales sean las mismas que aplican al resto del cuerpo humano.

Por años, estos grupos han estado pidiendo a la FDA que reduzca el período de aplazamiento de cinco años a 90 días, lo que significaría que un hombre que ha tenido relaciones sexuales con otro hombre podría donar tejidos siempre que dichas relaciones no hayan ocurrido dentro de los tres meses previos a su muerte.

Una de las voces que pide con más fuerza la reducción de estas restricciones es Sheryl J. Moore, quien ha sido una defensora desde la muerte de su hijo de 16 años, en 2013. Los órganos internos de Alexander “AJ” Betts Jr. se donaron exitosamente a siete personas, pero sus ojos fueron rechazados debido a una única pregunta realizada por la red de donantes: “¿AJ es gay?”.

Moore y un médico de Colorado llamado Michael Puente Jr. iniciaron una campaña llamada “Legalize Gay Eyes” que captó la atención de grupos nacionales de oftalmología y legisladores.

Puente, oftalmólogo pediátrico de la Escuela de Medicina de la Universidad de Colorado y del Hospital de Niños de Colorado, dijo que el actual mosaico de directrices para donantes no tiene sentido considerando los avances en la capacidad de examinar a los donantes potenciales para detectar el VIH.

“Un hombre gay puede donar todo su corazón para un trasplante, pero no puede donar solo la válvula del corazón”, dijo Puente, quien es gay. “Es esencialmente una prohibición categórica”.

La justificación de estas políticas, establecidas hace 30 años como un medio para prevenir la transmisión del VIH, ha sido socavada por el conocimiento adquirido a través del progreso científico.

Los que abogan por cambiar estas políticas dicen que ahora son innecesarias y discriminatorias porque se enfocan en grupos específicos de personas en lugar de en comportamientos particulares conocidos por aumentar el riesgo de VIH.

Desde 2022, el Centro de Evaluación e Investigación Biológica de la FDA ha incluido en su agenda cambios en las pautas de donación de tejidos, pero aún no ha tomado acciones concretas al respecto.

“Es simplemente inaceptable”, dijo el representante Joe Neguse (demócrata de Colorado) en un comunicado. Fue uno de los muchos miembros del Congreso que, en 2021, firmaron una carta diciendo que las actuales políticas de diferimiento perpetúan el estigma contra los hombres gays y deberían basarse en evaluaciones de riesgo individualizadas

“La política de la FDA debe derivarse de la mejor ciencia disponible, no de sesgos y prejuicios históricos”, decía la carta.

La FDA dijo a KFF Health News en un mensaje que, “aunque el riesgo absoluto de transmisión del VIH debido a procedimientos quirúrgicos oftalmológicos parece ser remoto, aún existen riesgos relativos”.

La agencia federal revisa rutinariamente el cribado y las pruebas de donantes “para determinar qué cambios, si los hay, son apropiados basados en el conocimiento científico y tecnológico en evolución”, dijo el comunicado. La FDA proporcionó una respuesta similar a Neguse en 2022.

En 2015, la FDA eliminó una política denominada “prohibición de sangre” (blood ban), que impedía a los hombres gays y bisexuales donar sangre, antes de reemplazarla en 2023 por una política que trata a todos los donantes potenciales de la misma manera.

Cualquiera que, en los últimos tres meses, haya tenido sexo anal y un nuevo compañero sexual o más de un compañero sexual no puede donar. Un estudio de la FDA encontró que, aunque los hombres que tienen sexo con hombres constituyen la mayoría de los nuevos diagnósticos de VIH en el país, un cuestionario era suficiente para identificar eficazmente a los donantes de bajo riesgo frente a los de alto riesgo.

El Servicio de Salud Pública de EE.UU. modificó las pautas para la donación de órganos en 2020. Nada impide a los hombres gays sexualmente activos donar sus órganos, aunque si han tenido sexo con otro hombre en los últimos 30 días (antes era un año) el paciente que va a recibir el órgano puede decidir si aceptarlo o no.

Pero Puente dijo que hombres gays como él no pueden donar sus córneas a menos que hayan sido célibes durante los cinco años previos a su muerte.

Descubrió que, en un solo año, al menos 360 personas habían sido rechazadas como donantes de córneas porque eran hombres que habían tenido sexo con otro hombre en los últimos cinco años, o en el último año en el caso de los donantes canadienses.

Las córneas son las pátinas transparentes que protegen los ojos del mundo exterior. Tienen el aspecto y la consistencia de una medusa transparente, y si un paciente recibe una puede significar que vuelva a ver. No contienen sangre ni ningún otro fluido corporal capaz de transmitir el VIH.

Los científicos sospechan que es por eso que no hay casos conocidos de un paciente que haya contraído VIH por un trasplante de córnea, incluso en casos en que esas córneas provenían de donantes de órganos que infectaron a recipientes.

Actualmente, a todos los donantes, ya sean de sangre, órganos o tejidos, se los examina para detectar VIH y dos tipos de hepatitis. Estas pruebas no son perfectas: aún existe lo que los científicos llaman un “período de ventana” posterior a la infección durante el cual el cuerpo del donante aún no ha producido una cantidad detectable del virus.

Pero tales ventanas ahora son bastante estrechas. Investigadores de los Centros para el Control y Prevención de Enfermedades (CDC) encontraron que las pruebas de ácido nucleico, que se utilizan comúnmente para examinar a los donantes, tienen poca probabilidad de fallar en detectar a alguien con VIH a menos que lo haya adquirido en las dos semanas anteriores a la donación.

Otro estudio estimó que, incluso si alguien tuvo sexo con una persona VIH positiva un par de semanas a un mes antes de donar, las probabilidades de que una prueba de ácido nucleico no detectara esa infección son menores a 1 en un millón.

“Muy bajas, pero no nulas”, dijo Sridhar Basavaraju, quien fue uno de los investigadores en ese estudio y dirige la Oficina de Seguridad de Sangre, Órganos y Otros Tejidos de los CDC. Dijo que el riesgo de hepatitis B no detectada es ligeramente mayor “pero aún bajo”.

Al menos un alto funcionario de la FDA ha estado de acuerdo indirectamente. Peter Marks, quien dirige el Centro de Evaluación e Investigación Biológica de la FDA, fue co autor de un informe el año pasado que decía que “tres meses cubren ampliamente” el período de ventana en el que alguien podría tener el virus, pero a niveles demasiado bajos para ser detectados por las pruebas.

Scott Haber, director de defensa de la salud pública en la Academia Americana de Oftalmología, dijo que la postura de su grupo es que la pauta de donación de tejidos “debería estar al menos más alineada” con la de las donaciones de sangre.

Kevin Corcoran, quien lidera la Eye Bank Association of America, dijo que los cinco años de abstinencia requeridos para los donantes de córneas que son gays o bisexuales no solo están “desactualizados”, sino que también son poco prácticos: obliga a familiares en duelo a recordar cinco años de historia sexual de un ser querido.

Esa es la situación en la que Moore se encontró en un día de julio de 2013.

Su hijo amaba el anime y los musicales. Era malo contando chistes pero bueno ayudando a las personas: Betts Jr. una vez reemplazó el dinero de cumpleaños perdido de su hermana pequeña con sus propios ahorros, contó ella, y eligió entusiastamente ser donante de órganos cuando obtuvo su licencia de conducir. Moore recordó haberle dicho a su hijo que ignorara el acoso de los intolerantes antigay en la escuela.

“Los niños del coro le habían dicho que iba a ir al infierno por ser gay, y que mejor se suicidara para ahorrarse el tiempo”, recordó.

Ese verano, lo hizo. En el hospital, mientras el personal médico buscaba señales de actividad cerebral en el niño antes de que muriera, Moore se encontró respondiendo una lista de preguntas de la Red de Donantes de Iowa, incluyendo: “¿AJ es gay?”

“Recuerdo muy vividamente decirles, ‘Bueno, ¿qué quieren decir con, “¿Era gay?” Quiero decir, él nunca tuvo sexo penetrativo,'” dijo ella. “Pero ellos dijeron, ‘Solo necesitamos saber si él era gay.’ Y yo dije, ‘Sí, él se identificaba como gay'”.

La Red de Donantes de Iowa dijo en un comunicado que la organización no puede comentar sobre el caso de Moore, pero agregó, “Esperamos sinceramente un cambio en la política de la FDA para alinearse con el enfoque más inclusivo visto en las pautas de donación de sangre, permitiéndonos honrar la decisión de todas las personas que desean salvar vidas a través de la donación de órganos y tejidos”.

Moore dijo que los órganos de su hijo ayudaron a salvar o prolongar la vida de otras siete personas, incluyendo a un niño que recibió su corazón y una mujer de mediana edad que recibió su hígado. Moore a veces intercambia mensajes con ella en Facebook.

Se enteró un año después que las córneas de su hijo fueron rechazadas como tejido donante debido a esa charla con la Red de Donantes de Iowa sobre la sexualidad de su hijo.

“Sentí que desperdiciaron partes del cuerpo de mi hijo”, dijo Moore. “Sentí profundamente que AJ seguía siendo acosado más allá de la tumba”.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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FDA Urged To Relax Decades-Old Tissue Donation Restrictions for Gay and Bisexual Men

The federal government in 2020 and 2023 changed who it said could safely donate organs and blood, reducing the restrictions on men who have had sex with another man.

But the FDA’s restrictions on donated tissue, a catchall term encompassing everything from a person’s eyes to their skin and ligaments, remain in place. Advocates, lawmakers, and groups focused on removing barriers to cornea donations, in particular, said they are frustrated the FDA hasn’t heeded their calls. They want to align the guidelines for tissue donated by gay and bisexual men with those that apply to the rest of the human body.

Such groups have been asking the FDA for years to reduce the deferral period from five years to 90 days, meaning a man who has had sex with another man would be able to donate tissue as long as such sex didn’t occur within three months of his death.

One of the loudest voices on lightening the restrictions is Sheryl J. Moore, who has been an advocate since her 16-year-old son’s death in 2013. Alexander “AJ” Betts Jr.’s internal organs were successfully donated to seven people, but his eyes were rejected because of a single question asked by the donor network: “Is AJ gay?”

Moore and a Colorado doctor named Michael Puente Jr. started a campaign called “Legalize Gay Eyes” and together got the attention of national eye groups and lawmakers.

Puente, a pediatric ophthalmologist with the University of Colorado School of Medicine and Children’s Hospital Colorado, said the current patchwork of donor guidelines is nonsensical considering advancements in the ability to test potential donors for HIV.

“A gay man can donate their entire heart for transplant, but they cannot donate just the heart valve,” said Puente, who is gay. “It’s essentially a categorical ban.”

The justification for these policies, set 30 years ago as a means of preventing HIV transmission, has been undercut by the knowledge gained through scientific progress. Now, they are unnecessary and discriminatory in that they focus on specific groups of people rather than on specific behaviors known to heighten HIV risk, according to those who advocate for changing them.

Since 2022, the FDA’s Center for Biologics Evaluation and Research has put changes to the tissue guidance on its agenda but has yet to act on them.

“It is simply unacceptable,” Rep. Joe Neguse (D-Colo.) said in a statement. He was one of dozens of Congress members who signed a letter in 2021 that said the current deferral policies perpetuate stigma against gay men and should be based on individualized risk assessments instead.

“FDA policy should be derived from the best available science, not historic bias and prejudice,” the letter read.

The FDA said in a statement to KFF Health News that, “while the absolute risk transmission of HIV due to ophthalmic surgical procedures appears to be remote, there are still relative risks.”

The agency routinely reviews donor screening and testing “to determine what changes, if any, are appropriate based on technological and evolving scientific knowledge,” the statement said. The FDA provided a similar response to Neguse in 2022.

In 2015, the FDA got rid of a policy dubbed the “blood ban,” which barred gay and bisexual men from donating blood, before replacing it in 2023 with a policy that treats all prospective donors the same. Anyone who, in the past three months, has had anal sex and a new sexual partner or more than one sexual partner is not allowed to donate. An FDA study found that, while men who have sex with men make up most of the nation’s new HIV diagnoses, a questionnaire was enough to effectively identify low-risk versus high-risk donors.

The U.S. Public Health Service adjusted the guidelines for organ donation in 2020. Nothing prevents sexually active gay men from donating their organs, though if they’ve had sex with another man in the past 30 days — down from a year — the patient set to receive the organ can decide whether or not to accept it.

But Puente said gay men like him cannot donate their corneas unless they were celibate for five years prior to their death.

He found that, in one year alone, at least 360 people were rejected as cornea donors because they were men who had had sex with another man in the past five years, or in the past year in the case of Canadian donors.

Corneas are the clear domes that protect the eyes from the outside world. They have the look and consistency of a transparent jellyfish, and transplanting one can restore a person’s sight. They contain no blood, nor any other bodily fluid capable of transmitting HIV. Scientists suspect that’s why there are no known cases of a patient contracting HIV from a cornea transplant, even when those corneas came from donors of organs that did infect recipients.

Currently, all donors, whether of blood, organs, or tissue, are tested for HIV and two types of hepatitis. Such tests aren’t perfect: There is still what scientists call a “window period” following infection during which the donor’s body has not yet produced a detectable amount of virus.

But such windows are now quite narrow. Researchers with the Centers for Disease Control and Prevention found that nucleic acid tests, which are commonly used to screen donors, are unlikely to miss someone having HIV unless they acquired it in the two weeks preceding donation. Another study estimated that even if someone had sex with an HIV-positive person a couple of weeks to a month before donating, the odds are less than 1 in a million that a nucleic acid test would miss that infection.

“Very low, but not zero,” said Sridhar Basavaraju, who was one of the researchers on that study and directs the CDC’s Office of Blood, Organ, and Other Tissue Safety. He said the risk of undetected hepatitis B is slightly higher “but still low.”

At least one senior FDA official has indirectly agreed. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, co-authored a report last year that said “three months amply covers” the window period in which someone might have the virus but at levels too low for tests to pick up. Scott Haber, director of public health advocacy at the American Academy of Ophthalmology, said his group’s stance is that the tissue donation guideline “should be at least roughly in alignment” with that for blood donations.

Kevin Corcoran, who leads the Eye Bank Association of America, said the five-year abstinence required of corneal donors who are gay or bisexual isn’t just “badly out of date” but also impractical, requiring grieving relatives to recall five years of their loved one’s sexual history.

That’s the situation Moore found herself in on a July day in 2013.

Her son loved anime, show tunes, and drinking pop out of the side of his mouth. He was bad at telling jokes but good at helping people: Betts once replaced his little sister’s lost birthday money with his own savings, she said, and enthusiastically chose to be an organ donor when he got his driver’s license. Moore remembered telling her son to ignore the harassment by antigay bigots at school.

“The kids in show choir had told him he’s going to hell for being gay, and he might as well just kill himself to save himself the time,” she recalled.

That summer, he did. At the hospital, as medical staff searched for signs of brain activity in the boy before he died, Moore found herself answering a list of questions from Iowa Donor Network, including, she recalled: “Is AJ gay?”

“I remember very vividly saying to them, ‘Well, what do you mean by, “Was he gay?” I mean, he’s never had penetrative sex,’” she said. “But they said, ‘We just need to know if he was gay.’ And I said, ‘Yes, he identified as gay.’”

The Iowa Donor Network said in a statement that the organization can’t comment on Moore’s case, but said, “We sincerely hope for a shift in FDA policy to align with the more inclusive approach seen in blood donation guidelines, enabling us to honor the decision of all individuals who want to save lives through organ and tissue donation.”

Moore said her son’s organs helped save or prolong the lives of seven other people, including a boy who received his heart and a middle-aged woman who received his liver. Moore sometimes exchanges messages with her on Facebook.

She found out a year later that her son’s corneas were rejected as donor tissue because of that conversation with Iowa Donor Network about her son’s sexuality.

“I felt like they wasted my son’s body parts,” Moore said. “I very much felt like AJ was continuing to be bullied beyond the grave.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Los Angeles County Launches Ambitious Plan To Tackle Medical Debt. Hospitals Groan.

LOS ANGELES — Los Angeles County has launched one of the most ambitious efforts in the nation to tackle medical debt, targeting hospitals for their role in feeding a $2.9 billion problem.

For over a year, the nation’s most populous county has worked on a comprehensive plan to track patient debt and hospital collection practices; boost bill forgiveness for low-income patients; and buy up and forgive billions in medical debt — an effort helmed by its Department of Public Health.

Though LA County isn’t the first government entity to confront this crisis, what sets it apart is how it casts medical debt not as a political issue, but as an urgent public health threat as prevalent as asthma and diabetes.

“Nobody in the county of LA who is facing economic limitations should have that impact their ability to get the kind of health care, the kinds of services and support that we all need and are essential to optimal well-being,” public health department director Barbara Ferrer said at a medical debt symposium April 10.

Mona Shah of Community Catalyst, a national health equity and policy organization, called the county’s efforts bold — tackling the root causes of medical debt, in addition to providing immediate debt relief, with input and participation from health plans, hospitals, community organizations, and government partners. Shah said the county’s population of about 10 million adds to the significance of its initiative.

But on the eve of the symposium, the local hospital association called on the county to revise its plan.

“We believe the proposed DPH [Department of Public Health] debt relief program and data collection effort will only burden hospitals with unnecessary requirements, without ultimately helping to address the underlying issue,” wrote George Greene, CEO of the Hospital Association of Southern California, in a letter to the LA County Board of Supervisors.

Many of the county’s recommendations would require hospitals to change their processes and add reporting duties. For instance, the county is asking hospitals to inform it when patient debt is sent to collections and pressing hospitals to improve access to financial assistance programs. Although state law requires hospitals to provide assistance, patient advocates say many don’t make it easy for patients to access.

Adena Tessler, LA County regional vice president for the hospital association, told KFF Health News the industry provides ample financial assistance and that the county is putting too much emphasis on hospitals’ role in the debt crisis, when other sectors of the health care system, such as insurers, should share the blame.

Tessler said the county plan should include all players, including health plans, provider groups, and ambulance providers.

“Medical debt is a problem, and we want to be a part of the solution,” Tessler said. “But hospitals are not the only source of medical debt.”

Medical debt affects 4 in 10 adults in the U.S., according to a KFF Health News analysis. LA County found, in its own analysis this year, that about 785,000 residents were burdened in 2022 with a total of $2.9 billion in medical debt.

The county analysis shows that medical debt disproportionately affects people of color, low-income people, and families with children. Having medical debt more than doubled the likelihood that patients would delay or forgo health care or prescriptions or be at risk of losing housing or going hungry.

Nationally, a handful of states have passed rules to limit medical debt collection or bolster hospital financial assistance policies. Some jurisdictions have relieved residents of debt. Connecticut, Colorado, and New York enacted laws in the last two years to ban medical debt on credit reports, which can depress credit scores and make it harder for patients to get a job, rent an apartment, or secure a car loan. California lawmakers have proposed similar legislation, and the federal Consumer Financial Protection Bureau is also developing a set of rules.

“It’s a huge public health problem,” said Naman Shah, medical and dental affairs director at the public health department. “We in public health try to shift the determinants of health. Those are things that impact health deeply and impact people widely. Medical debt fulfills both of those. It’s important that we see this as a health issue, and not just a regulatory issue.”

The department made initial recommendations last spring, then further developed them with the backing of the Board of Supervisors, which described medical debt as “pervasive” and “causing financial, mental, and physical harm … especially to those from historically marginalized communities.”

Shah said that while the department continues to take hospital input and has addressed some of the association’s “misunderstandings,” officials are moving ahead with the plan. Tessler agreed the focus is on collaboration, not halting the county plan.

Over the next several months, the county plans to score hospitals based on financial assistance accessibility and provide them with templates and guidelines to make financial assistance less confusing and less burdensome for patients.

States such as Washington, Oregon, and Maryland have developed similar materials for hospitals.

The county’s goals also call for other debt prevention strategies, including working with plans and providers to better educate consumers to avoid surprise billing and out-of-network charges.

Shah said he was surprised by the timing of the hospital association’s letter, especially since county officials and hospital representatives met several times before the April symposium. He agreed it is important to tackle all sources of medical debt but said hospitals are a reasonable place to start. Nearly 75% of adults with medical debt owe some or all of it to hospitals, according to a 2023 Urban Institute analysis.

“We want to get the most bang for our buck,” Shah said. “The largest bill that a patient receives is not a dental bill. It’s not an office bill. It’s a hospital bill.”

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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4 Ways Vaccine Skeptics Mislead You on Measles and More

Measles is on the rise in the United States. So far this year, the number of cases is about 17 times what it was, on average, during the same period in each of the four years before, according to the Centers for Disease Control and Prevention. Half of the people infected — mainly children — have been hospitalized.

It’s going to get worse, largely because a growing number of parents are deciding not to get their children vaccinated against measles as well as diseases like polio and pertussis. Unvaccinated people, or those whose immunization status is unknown, account for 80% of the measles cases this year. Many parents have been influenced by a flood of misinformation spouted by politicians, podcast hosts, and influential figures on television and social media. These personalities repeat decades-old notions that erode confidence in the established science backing routine childhood vaccines. KFF Health News examined the rhetoric and explains why it’s misguided:

The No-Big-Deal Trope

A common distortion is that vaccines aren’t necessary because the diseases they prevent are not very dangerous, or too rare to be of concern. Cynics accuse public health officials and the media of fear-mongering about measles even as 19 states report cases.

For example, an article posted on the website of the National Vaccine Information Center — a regular source of vaccine misinformation — argued that a resurgence in concern about the disease “is ‘sky is falling’ hype.” It went on to call measles, mumps, chicken pox, and influenza “politically incorrect to get.”

Measles kills roughly 2 of every 1,000 children infected, according to the CDC. If that seems like a bearable risk, it’s worth pointing out that a far larger portion of children with measles will require hospitalization for pneumonia and other serious complications. For every 10 measles cases, one child with the disease develops an ear infection that can lead to permanent hearing loss. Another strange effect is that the measles virus can destroy a person’s existing immunity, meaning they’ll have a harder time recovering from influenza and other common ailments.

Measles vaccines have averted the deaths of about 94 million people, mainly children, over the past 50 years, according to an April analysis led by the World Health Organization. Together with immunizations against polio and other diseases, vaccines have saved an estimated 154 million lives globally.

Some skeptics argue that vaccine-preventable diseases are no longer a threat because they’ve become relatively rare in the U.S. (True — due to vaccination.) This reasoning led Florida’s surgeon general, Joseph Ladapo, to tell parents that they could send their unvaccinated children to school amid a measles outbreak in February. “You look at the headlines and you’d think the sky was falling,” Ladapo said on a News Nation newscast. “There’s a lot of immunity.”

As this lax attitude persuades parents to decline vaccination, the protective group immunity will drop, and outbreaks will grow larger and faster. A rapid measles outbreak hit an undervaccinated population in Samoa in 2019, killing 83 people within four months. A chronic lack of measles vaccination in the Democratic Republic of the Congo led to more than 5,600 people dying from the disease in massive outbreaks last year.

The ‘You Never Know’ Trope

Since the earliest days of vaccines, a contingent of the public has considered them bad because they’re unnatural, as compared with nature’s bounty of infections and plagues. “Bad” has been redefined over the decades. In the 1800s, vaccine skeptics claimed that smallpox vaccines caused people to sprout horns and behave like beasts. More recently, they blame vaccines for ailments ranging from attention-deficit/hyperactivity disorder to autism to immune system disruption. Studies don’t back the assertions. However, skeptics argue that their claims remain valid because vaccines haven’t been adequately tested.

In fact, vaccines are among the most studied medical interventions. Over the past century, massive studies and clinical trials have tested vaccines during their development and after their widespread use. More than 12,000 people took part in clinical trials of the most recent vaccine approved to prevent measles, mumps, and rubella. Such large numbers allow researchers to detect rare risks, which are a major concern because vaccines are given to millions of healthy people.

To assess long-term risks, researchers sift through reams of data for signals of harm. For example, a Danish group analyzed a database of more than 657,000 children and found that those who had been vaccinated against measles as babies were no more likely to later be diagnosed with autism than those who were not vaccinated. In another study, researchers analyzed records from 805,000 children born from 1990 through 2001 and found no evidence to back a concern that multiple vaccinations might impair children’s immune systems.

Nonetheless, people who push vaccine misinformation, like candidate Robert F. Kennedy Jr., dismiss massive, scientifically vetted studies. For example, Kennedy argues that clinical trials of new vaccines are unreliable because vaccinated kids aren’t compared with a placebo group that gets saline solution or another substance with no effect. Instead, many modern trials compare updated vaccines with older ones. That’s because it’s unethical to endanger children by giving them a sham vaccine when the protective effect of immunization is known. In a 1950s clinical trial of polio vaccines, 16 children in the placebo group died of polio and 34 were paralyzed, said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and author of a book on the first polio vaccine.

The Too-Much-Too-Soon Trope

Several bestselling vaccine books on Amazon promote the risky idea that parents should skip or delay their children’s vaccines. “All vaccines on the CDC’s schedule may not be right for all children at all times,” writes Paul Thomas in his bestselling book “The Vaccine-Friendly Plan.” He backs up this conviction by saying that children who have followed “my protocol are among the healthiest in the world.”

Since the book was published, Thomas’ medical license was temporarily suspended in Oregon and Washington. The Oregon Medical Board documented how Thomas persuaded parents to skip vaccines recommended by the CDC, and reported that he “reduced to tears” a mother who disagreed.  Several children in his care came down with pertussis and rotavirus, diseases easily prevented by vaccines, wrote the board. Thomas recommended fish oil supplements and homeopathy to an unvaccinated child with a deep scalp laceration, rather than an emergency tetanus vaccine. The boy developed severe tetanus, landing in the hospital for nearly two months, where he required intubation, a tracheotomy, and a feeding tube to survive.

The vaccination schedule recommended by the CDC has been tailored to protect children at their most vulnerable points in life and minimize side effects. The combination measles, mumps, and rubella vaccine isn’t given for the first year of a baby’s life because antibodies temporarily passed on from their mother can interfere with the immune response. And because some babies don’t generate a strong response to that first dose, the CDC recommends a second one around the time a child enters kindergarten because measles and other viruses spread rapidly in group settings.

Delaying MMR doses much longer may be unwise because data suggests that children vaccinated at 10 or older have a higher chance of adverse reactions, such as a seizure or fatigue.

Around a dozen other vaccines have discrete timelines, with overlapping windows for the best response. Studies have shown that MMR vaccines may be given safely and effectively in combination with other vaccines.

’They Don’t Want You to Know’ Trope

Kennedy compares the Florida surgeon general to Galileo in the introduction to Ladapo’s new book on transcending fear in public health. Just as the Roman Catholic inquisition punished the renowned astronomer for promoting theories about the universe, Kennedy suggests that scientific institutions oppress dissenting voices on vaccines for nefarious reasons.

“The persecution of scientists and doctors who dare to challenge contemporary orthodoxies is not a new phenomenon,” Kennedy writes. His running mate, lawyer Nicole Shanahan, has campaigned on the idea that conversations about vaccine harms are censored and the CDC and other federal agencies hide data due to corporate influence.

Claims like “they don’t want you to know” aren’t new among the anti-vaccine set, even though the movement has long had an outsize voice. The most listened-to podcast in the U.S., “The Joe Rogan Experience,” regularly features guests who cast doubt on scientific consensus. Last year on the show, Kennedy repeated the debunked claim that vaccines cause autism.

Far from ignoring that concern, epidemiologists have taken it seriously. They have conducted more than a dozen studies searching for a link between vaccines and autism, and repeatedly found none. “We have conclusively disproven the theory that vaccines are connected to autism,” said Gideon Meyerowitz-Katz, an epidemiologist at the University of Wollongong in Australia. “So, the public health establishment tends to shut those conversations down quickly.”

Federal agencies are transparent about seizures, arm pain, and other reactions that vaccines can cause. And the government has a program to compensate individuals whose injuries are scientifically determined to result from them. Around 1 to 3.5 out of every million doses of the measles, mumps, and rubella vaccine can cause a life-threatening allergic reaction; a person’s lifetime risk of death by lightning is estimated to be as much as four times as high.

“The most convincing thing I can say is that my daughter has all her vaccines and that every pediatrician and public health person I know has vaccinated their kids,” Meyerowitz-Katz said. “No one would do that if they thought there were serious risks.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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