That was on Tuesday, Oct. 8. The next morning a social worker and a doctor woke Trumble to say her discharge was canceled. CVS would no longer provide her home nutrition, and she had to stay in the hospital. “I was dropped between Tuesday night and Wednesday morning with no care for my life or my health,” Trumble said from her hospital bed eight days later.

After this article was published, on Oct. 18, Trumble said she was being discharged, after her caregivers found a replacement service. “I’m just afraid their supplies will run out,” she said. “My backup plan is always to go back to the hospital.”

Trumble is among 25,000 U.S. patients whose survival depends on parenteral nutrition, or PN — IV bags containing life-sustaining amino acids, sugars, fats, vitamins, and electrolytes. Hurricane Helene wrecked a factory in North Carolina that produced 60% of the fluids their sustenance is mixed from. About two weeks later, CVS announced that its Coram division, a leading infusion pharmacy, was exiting the PN and IV antibiotics business.

The hurricane led Baxter International to ration its dwindling supplies. Pharmacies that supply Trumble and other patients like her were already plagued by shortages, and the rationing means the remaining infusion pharmacies can’t take on the customers cut off by CVS, said David Seres, director of medical nutrition at Columbia University Medical Center in New York.

At the Mayo Clinic in Rochester, Minnesota, seven or eight patients were ready to go home Tuesday but couldn’t be discharged because no infusion company would accept them, said Manpreet Mundi, a Mayo endocrinologist. The patients would fall ill within a day or two without this nutrition, he said.

By Oct. 18, home supplies had been located for all but a few of them, Mundi said. “A lot of public pressure” on Coram was starting to have an effect, he said.

Although the FDA is allowing emergency imports of IV fluids wiped out by Helene, as well as production of some of the fluids by U.S. compounding pharmacies, it’s unclear how long it will take to replenish supplies, said Mundi, who is a board member of the American Society for Parenteral and Enteral Nutrition and medical adviser to the Oley Foundation, which advocates for PN patients. “We’re trying to raise awareness that this could get worse before it gets better,” he said.

The patients who rely on PN have a variety of conditions that render them unable to digest food. Some have congenital abnormalities or disorders like Crohn’s disease that led to surgical removal of bowel sections. Others were scarred by cancer, car accidents, or gunfire, or are preemies born with underdeveloped intestines. In most patients, the fluid is pumped through a catheter into a large vein near the heart.

A crisis hit this community two years ago when CVS Health announced that it was shutting half of the 71 Coram pharmacies.

CVS, which recently announced nearly 3,000 layoffs amid reports of a possible restructuring, on Oct. 8 began telling its remaining 800 to 1,000 PN customers that they would have to find other infusion pharmacies. A news release provided to KFF Health News suggested the phaseout would last into January, but for patients like Trumble, the impact was immediate.

Highly specialized infusion medicine is “a challenging environment” for all companies “and Coram has not been immune to these challenges,” the CVS release said. “As such, we have reevaluated our service offerings.”

When asked about Trumble’s case, CVS Health spokesperson Mike DeAngelis said the company would “try to resolve it.” The next day, a company called Optum stepped in to replace Coram, Trumble said.

It’s hard enough normally for such patients to find new suppliers for their materials, which can include 120 pounds of IV fluid per week.

Coram’s departure “made a big crisis that much worse,” Mundi said. “It’s become kind of a double whammy.”

The Baxter International North Cove plant produced most of the country’s high-concentration dextrose, a major source of energy for PN patients, as well as saline solution and sterile water, also vital supplies. A week after Helene hit, Hurricane Milton threatened sterile IV fluid supplier B. Braun Medical’s facility in Daytona Beach, Florida. The federal government helped truck 60 loads of the company’s inventory to a safe location, but the plant was spared the storm’s worst. It restarted production on Oct. 11.

That was a huge relief for Beth Gore, CEO of the Oley Foundation. She, her husband, and their six adopted children braved the storm’s seven hours of lashing wind in their home near Ruskin, Florida. Milton wrecked a car and part of the roof, but the family prayed through it all and somehow never lost power, though their neighbors did, Gore said. That kept the IV fluids fresh and the internet on, which calmed the kids.

Coram has supplied her youngest son, 15-year-old Manny, with PN for 13 years, and the family will need to find another supplier, she said.

“There’s been no relief” since Coram reduced its services in 2022, Gore said. “Now there’s this new twist.”

Her son gets care through Medicaid, whose reimbursement provides barely break-even margins for many infusion pharmacies, she said. Insurance limits, state licensing differences, and highly specific nutritional needs pose challenges for patients seeking new IV suppliers in the best of times, she said.

The FDA announced Oct. 9 that it would allow Baxter to import emergency supplies from Canada, China, Ireland, and the U.K. In the meantime, Baxter is prioritizing hospital patients over the home infusion companies — which lack backup supplies, Mundi said.

“We’re all on the phone 24/7,” said Kathleen Gura, president-elect of the American Society for Parenteral and Enteral Nutrition and pharmacy clinical research program manager at Boston Children’s Hospital. Her team is struggling to find new suppliers of IV nutrition at home for the 20 Coram patients among the 150 she sees.

“Some kids have a situation where they can’t absorb at all through their intestines and will die of dehydration if they can’t get IV,” Gura said.

The IV fluids lost in the Baxter disaster are key to all kinds of inpatient care. Many U.S. hospitals are conserving fluid by giving some patients oral hydration instead of IVs, or by delaying surgeries, said Soumi Saha, senior vice president of government affairs at Premier, which negotiates group hospital purchases.

President Joe Biden has invoked the Defense Production Act, which will enable the government to order companies to prioritize rebuilding the Baxter plant.

The military is flying in supplies from Baxter plants overseas, Saha said. Premier has also asked the FDA to put additional PN ingredients on its shortage list, which would allow large compounding facilities to produce the materials.

Ellie Rogers, 17, of Simpsonville, South Carolina, fears the worst if she can’t get her supplies. She suffers from a host of immunological and neurological ailments that require her to get four liters of IV fluid daily to stay alive, she said.

Her supplier, an Option Care Health pharmacy in South Carolina, informed the family Oct. 14 that instead of her weekly supply it was sending her enough bags for a day or two. “They really don’t know when they’re going to get what they need,” she said. Reducing the infusions in the past has led to dizziness, nausea, and pooling of her blood that “felt like my veins were going to explode.”

On Oct. 7, Crohn’s disease patient Hannah Hale’s infusion pharmacy called and said it couldn’t fill her standing weekly order of IV bags, urging her to find a new pharmacy.

“I called 14 infusion pharmacies and haven’t been able to find anyone to take me,” said the Dallas 37-year-old. She suffers from weight loss and low blood sugar, and rationing her supplies raises dangers of seizures or coma, she said.

Trumble, 52, who started on PN 13 months ago because of colon cancer and severe intestinal issues, said she was grateful to the hospital and gets excellent care there, but missed her mother, son, and 8-year-old grandson, Jordan — and her cats — during her 17-day hospitalization.

What’s worse, Trumble said, her mother and son, who get Medicaid payments to care for her, weren’t paid while she was away.

But without IV nutrition at home, she said, “I’d starve.”

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In KFF’s latest employer health benefits survey, company officials were asked how much of the rebates collected from drugmakers by pharmacy benefit managers, or PBMs, is returned to them. In recent years, the pharmaceutical industry has tried to deflect criticism of high drug prices by saying much of that income is siphoned off by the PBMs, companies that manage patients’ drug benefits on behalf of employers and health plans.

PBM leaders say they save companies and patients billions of dollars annually by obtaining rebates from drugmakers that they pass along to employers. Drugmakers, meanwhile, say they raise their list prices so high in order to afford the rebates that PBMs demand in exchange for placing the drugs on formularies that make them available to patients.

Leaders of the three largest PBMs — CVS Caremark, Optum RX and Express Scripts — all testified in Congress in July that 95% to 98% of the rebates they collect from drugmakers flow to employers.

For KFF’s survey of 2,142 randomly selected companies, officials from those with 500 or more employees were asked how much of the rebates negotiated by PBMs returned to the company as savings. About 19% said they received most of the rebates, 27% said some, and 16% said little. Thirty-seven percent of the respondents didn’t know.

While a larger percentage of officials from the largest companies said they got most or some of the rebates, the answers — and their contrast with the testimony of PBM leaders — reflect the confusion or ignorance of employers about what their drug benefit managers do, said survey leader Gary Claxton, a senior vice president at KFF, a health information nonprofit that includes KFF Health News.

“I don’t think they can ever know all the ways the money moves around because there are so many layers, between the wholesalers and the pharmacies and the manufacturers,” he said.

Critics say big PBMs — which are parts of conglomerates that include pharmacies, providers, and insurers — may conceal the size of their rebates by conducting negotiations through corporate-controlled rebate aggregators, or group purchasers, mostly based overseas in tax havens, that siphon off a percentage of the cash before it goes on the PBMs’ books.

PBMs also make money by encouraging or requiring patients to use affiliated specialty pharmacies, by skimping on payments to other pharmacies, and by collecting extra cash from drug companies through the federal 340B drug pricing program, which is aimed at lowering drug costs for low-income patients, said Antonio Ciaccia, CEO of 46brooklyn Research.

The KFF survey indicates how little employers understand the PBMs and their pricing policies. “Employers are generally frustrated by the lack of transparency into all the prices out there,” Claxton said. “They can’t actually know what’s true.”

Billionaire Mark Cuban started a company to undercut the PBMs by selling pharmaceuticals with transparent pricing policies. He tells Fortune 500 executives he meets, “You’re getting ripped off, you’re losing money because it’s not your core competency to understand how your PBM and health insurance contracts work,” Cuban told KFF Health News in an interview Tuesday.

Ciaccia, who has conducted PBM investigations for several states, said employers are not equipped to understand the behavior of the PBMs and often are surprised at how unregulated the PBM business is.

“You’d assume that employers want to pay less, that they would want to pay more attention,” he said. “But what I’ve learned is they are often underequipped, underresourced, and oftentimes not understanding the severity of the lack of oversight and accountability.”

Employers may assume the PBMs are acting in their best interest, but they don’t have a legal obligation to do so.

Prices can be all over the map, even those charged by the same PBM, Ciaccia said. In a Medicaid study he recently conducted, a PBM was billing employers anywhere from $2,000 to $8,000 for a month’s worth of imatinib, a cancer drug that can be bought as a generic for as little as $30.

PBM contracts often guarantee discounts of certain percentage points for generics and brand-name drugs. But the contracts then contain five pages of exclusions, and “no employer will know what they mean,” Ciaccia said. “That person doesn’t have enough information to have an informed opinion.”

The KFF survey found that companies’ annual premiums for coverage of individual employees had increased from an average of $7,739 in 2021 to $8,951 this year, and $22,221 to $25,572 for families. Among employers’ greatest concerns was how to cover increasingly popular weight loss drugs that list at $2,000 a month or more.

Only 18% of respondents said their companies covered drugs such as Wegovy for weight loss. The largest group of employers offering such coverage — 28% — was those with 5,000 or more employees.

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Yet his doctor, Noha Aboelata, believed the patient was sicker than the device showed. So she sent him for a lab test, which confirmed her suspicion that he needed supplemental oxygen at home.

Months later, in December 2020, Aboelata thought back to her patient as she read a New England Journal of Medicine article showing that pulse oximeters were three times as likely to miss dangerously low blood oxygen levels in Black patients as in white ones. At a time when Black Americans were dying of covid at high rates and hospitals struggled to find beds and oxygen for those needing them, the finding exposed one of the most blatant examples of institutional racism in American health care.

“I was like, ‘Were there other patients I missed?” said Aboelata, a family physician and the CEO of Oakland-based Roots Community Health. As she shared the article with colleagues, “there was so much anger and frustration because we had every reason to believe we could rely on this device, and it was systematically not working in the population that we served.”

State attorneys general and U.S. senators have pressed the FDA to take steps to eliminate pulse oximetry’s racial bias, which has caused delays in treatment and worse health outcomes, and more recently has raised concern about the reliability of hospital AI tools that draw on reams of data from the devices.

Aboelata’s clinic has sued producers and stores that sell oximeters, demanding they pull the devices or add safety warnings to the labels. Many of her patients rely on home oxygen, which requires accurate readings for Medicare to cover.

But getting rid of the devices, central to care for heart and lung diseases, sleep apnea, and other conditions, isn’t an option.

Since the 1990s, the convenient fingertip clamps have come to stand in for many uses of arterial blood gas readings, which are the gold standard for determining oxygen levels but dangerous if not done carefully. Makers of oximeters will sell around $3 billion of them this year because they are used in nearly every hospital, clinic, and long-term care facility. During the pandemic, hundreds of thousands of Americans bought them for home use.

One of them was Walter Wilson, a 70-year-old businessman in San Jose who has had two kidney transplants since 2000. Wilson contracted covid last December but delayed visiting a doctor because his home pulse oximetry readings were in the normal range.

“I’m a dark-complected Black guy. I was very sick. Had the oximeter picked that up I would have gotten to the hospital sooner,” he said.

Wilson ended up back on dialysis after several years of good health. Now he’s looking to join a class action lawsuit against the device manufacturers.

“They’ve known for years that people with darker skin get bad readings,” he said, “but they tested them on healthy white people.”

After years of little action on the issue, the FDA in 2021 sent a safety warning to doctors about oximeters. It has also funded research to improve the devices and promised to issue new guidelines for how to make them.

But as the FDA polishes draft guidelines it had hoped to publish by Oct. 1, clinicians and scientists are unsure what to expect. The agency has indicated it will recommend that manufacturers test new oximeters on more people, including a large percentage with dark-pigmented skin.

Because of industry pushback, however, the guidance isn’t expected to ask device makers to test oximeters under real-world conditions, said Michael Lipnick, a University of California-San Francisco anesthesiologist and researcher.

Hospitalized people are often dehydrated, with restricted blood flow to their extremities. This condition, known as low perfusion — essentially, poor circulation — is particularly common with cardiovascular disease, which is more prevalent in Black patients.

Pigmentation and poor perfusion “work together to degrade pulse oximetry performance,” said Philip Bickler, who directs the Hypoxia Research Lab at UCSF. “During covid, Black patients showed up sicker because of all the barriers those patients face in accessing health care. They’re showing up on death’s door, and their perfusion is lower.”

The FDA guidance isn’t expected to require manufacturers to measure how well their devices perform in patients with poor perfusion. All this means that the FDA’s efforts could lead to devices that work in healthy dark-skinned adults but do “not fix the problem,” said Hugh Cassiere, who chairs a panel for the FDA’s Medical Devices Advisory Committee, at its February meeting.

A History of Inaction

Although some recent industry-sponsored studies have shown that certain devices work across skin tones, research dating to the 1980s has found discrepancies in pulse oximetry. In 2005, Bickler and other scientists at the Hypoxia Lab published evidence that three leading devices consistently failed to detect hypoxemia in darkly pigmented patients — especially those who were severely oxygen-depleted. Noting that these readings could be crucial to directing treatment, the authors called for oximeters to carry warnings.

The FDA’s response was modest. Its regulatory pathway for pulse oximeters clears them for sale as long as they show “substantial equivalence” to devices already on the market. In a 2007 draft guidance document, the FDA suggested that tests of new oximeters could “include a sufficient number of subjects with dark skin pigmentation, e.g., 30%.” However, the final guidance, issued in 2013, recommended “at least 2 darkly pigmented subjects or 15% of your subject pool, whichever is larger.” The studies were required to have only 10 subjects. And the agency did not define “dark-pigmented.”

Testing the devices involves fitting patients with masks that control the gases they breathe, while simultaneously taking pulse oximetry readings and samples of arterial blood that are fed into a highly accurate measuring device, invented by the Hypoxia Lab’s late founder, John Severinghaus.

Bickler, who evinces the bemused skepticism of a seasoned car mechanic when discussing the scores of devices his lab has tested, said “you can’t always trust what the manufacturers say.”

Their data, he said, ranges from “completely inaccurate” to “obtained under absolutely ideal conditions, nothing like a real-world performance.”

During the pandemic, a medical charity approached the lab about donating thousands of oximeters to poor countries. The oximeters it had chosen “weren’t very good,” he said. After that, the lab set up its own ratings page, a kind of Consumer Reports for pulse oximeters.

According to its tests, some expensive devices don’t work; a few of the $35 gadgets are more effective than competitors costing $350. Over a third of the marketed devices the lab has tested don’t meet current FDA standards, according to the site.

To investigate whether real-world tests of oximeters are feasible, the FDA funded a UCSF study that has recruited about 200 intensive care unit patients. The data from the study is being prepared to undergo peer review for publication, Bickler said.

He said the lab did not warm the hands of patients in the study, which is the customary practice of manufacturers when they test their devices. Warming assures better circulation in the finger the device is attached to.

“It affects the signal-to-noise ratio,” Bickler said. “Remember when car radios had AM stations, and you’d get a lot of static? That’s what poor perfusion does — it causes noise, or static that can obscure a clear signal from the device.”

Hypoxia Lab scientists — and doctors in the real world — don’t warm patients’ hands. But “the industry people can’t agree on how to handle it,” he said.

Masimo, a company that says it has the most accurate pulse oximeters on the market, would happily comply with any FDA guidance, Daniel Cantillon, Masimo’s chief medical officer, said in an interview.

How Much To Fix the Problem?

The very best devices, according to the Hypoxia Lab, cost $6,000 or more. That points to another problem.

With better accuracy, “you are going to reduce patient access to devices for a large proportion of the world that simply can’t afford them,” Lipnick said.

Even if the FDA can’t please everyone, its anticipated call for more people with darker skin in oximetry tests will “assure there’s real diversity in the development and testing of those devices before they come to market,” Lipnick said. “That bar has been too low for decades.”

It is difficult to assess harm to individuals from faulty oximeter readings, because these errors are often one factor in a chain of events. But studies at Johns Hopkins University and elsewhere indicated that patients whose oxygen depletion wasn’t noticed — possibly thousands of them — had delayed treatment and worse outcomes.

Already, Aboelata said, a few manufacturers — Zewa Medical Technology, Veridian Healthcare, and Gurin Products — have responded to the Roots Community Health lawsuit by including warnings about their devices’ limitations.

There’s not much she and other clinicians can do in daily practice, she said, other than establish a baseline reading with each new patient and be on the lookout for notable drops. Hospitals have other tools to check oxygen levels, but correct readings are critical for outpatient care, she said. In 2022, Connecticut enacted a law banning insurers from denying home oxygen or other services based solely on pulse oximetry readings.

But “adapting around the crappy device isn’t the solution,” said Theodore Iwashyna, the Johns Hopkins Bloomberg School of Public Health professor who co-authored the New England Journal of Medicine article. “A less crappy device is the solution.”

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Sin embargo  su médica, Noha Aboelata, creyó que estaba más enfermo que lo que indicaba el aparato. Así que lo envió a hacerse unos análisis de laboratorio que confirmaron su sospecha: el hombre necesitaba oxígeno suplementario en casa.

Meses después, en diciembre de 2020, Aboelata volvió a pensar en su paciente mientras leía el New England Journal of Medicine. El artículo señalaba que los oxímetros de pulso tenían tres veces más probabilidades de no detectar niveles peligrosamente bajos de oxígeno en sangre en pacientes negros que en pacientes blancos.

En un momento en el que los estadounidenses de raza negra morían de covid a un ritmo elevado y los hospitales luchaban por encontrar camas y oxígeno para quienes los necesitaban, el hallazgo puso al descubierto uno de los ejemplos más flagrantes de racismo institucional en la atención médica estadounidense.

“Me pregunté si otros pacientes se me habrían pasado por alto”, reflexionó Aboelata, médica de familia y directora ejecutiva de Roots Community Health, con sede en Oakland.

Los colegas con quienes compartió el artículo tuvieron percepciones similares. “Sentimos mucha rabia y frustración porque teníamos todos los motivos para creer que podíamos confiar en este dispositivo pero nos dimos cuenta de que el oxímetro fallaba sistemáticamente en la población a la que atendíamos”, explicó.

Fiscales estatales y senadores de EE.UU. han presionado a la Administración de Drogas y Alimentos (FDA) para que tome medidas que ayuden a eliminar la desviación racial en los oxímetros de pulso.

Los funcionarios entienden que esto ha causado retrasos en los tratamientos y resultados desfavorables en la atención de salud. Más recientemente, esta falla del funcionamiento de los oxímetros de pulso también ha generado preocupación sobre la fiabilidad de las herramientas de Inteligencia Artificial en los hospitales, que dependen mucho de los datos que se obtienen de estos dispositivos.

La clínica de Aboelata ha demandado a los fabricantes y a los comercios que venden oxímetros, planteando la exigencia de que retiren estos dispositivos o por lo menos les agreguen advertencias de seguridad en las etiquetas. Muchos de sus pacientes dependen de la provisión de oxígeno domiciliario y para que el Medicare lo cubra es necesario brindar información precisa.

Sin embargo, eliminarlos no es una opción porque son fundamentales para el tratamiento de enfermedades cardíacas y pulmonares, la apnea del sueño y otras afecciones.

Desde la década de 1990, las cómodas pinzas en la yema de los dedos han sustituido en muchos usos a las lecturas de gases en sangre arterial, que son una referencia definitiva para determinar los niveles de oxígeno en sangre pero también son peligrosas si no se efectúan con cuidado.

Este año, los fabricantes de oxímetros de pulso venderán alrededor de $ 3.000 millones de estos pequeños aparatitos que se utilizan en casi todos los hospitales, clínicas y residencias para adultos mayores. Durante la pandemia, cientos de miles de estadounidenses los compraron para usarlos en su propio hogar.

Uno de ellos fue Walter Wilson, un empresario de 70 años que vive en San José, California. Wilson, que ha atravesado dos trasplantes de riñón desde el año 2000, contrajo covid en diciembre de 2023 pero retrasó la visita al médico porque los indicadores que veía en el oxímetro de pulso que utilizaba en su casa estaban en el rango normal.

“Soy un hombre negro, de piel oscura. Estaba muy enfermo. Si el oxímetro lo hubiera detectado, hubiera ido mucho antes al hospital”, explicó.

Wilson acabó de nuevo en diálisis tras varios años de estar con buena salud. Ahora quiere unirse a una demanda colectiva contra los fabricantes del dispositivo.

“Desde hace años saben que las personas con piel más oscura obtienen lecturas incorrectas”, dijo, “pero solo los probaron en personas blancas saludables”.

Después de dejar pasar el tiempo sin hacer mucho sobre este problema, en 2021 la FDA envió a los médicos un alerta de seguridad sobre los oxímetros de pulso. Por otra parte, financió investigaciones para mejorar los dispositivos y ha prometido publicar nuevas directrices sobre cómo fabricarlos.

Pero mientras la FDA trabajaba en un borrador de directrices, los médicos y los científicos no saben a qué atenerse. La agencia ha informado que recomendará a los fabricantes que prueben los nuevos oxímetros en más personas, y que incluyan un gran porcentaje de individuos con piel de pigmentación oscura.

Sin embargo, a causa de la resistencia que presentó la industria, los fabricantes de dispositivos no tendrán que probar los oxímetros en condiciones reales, según Michael Lipnick, anestesiólogo e investigador de la Universidad de California-San Francisco (UCSF).

Las personas hospitalizadas suelen estar deshidratadas y mostrar un flujo sanguíneo restringido en las extremidades. Esta situación, conocida como “baja perfusión” —es decir, mala circulación—, es especialmente habitual en las enfermedades cardiovasculares, que a la vez son más frecuentes entre los pacientes de raza negra.

La pigmentación y la mala perfusión “actúan conjuntamente para degradar el rendimiento de la pulsioximetría”, explicó Philip Bickler, director del Laboratorio de Investigación sobre la Hipoxia de la UCSF. “Durante la pandemia de covid, los pacientes negros llegaban al hospital en peores condiciones debido a todas las barreras a las que se enfrentan para acceder a la atención médica. Los recibíamos en un estado crítico y su perfusión era mucho menor”, añadió.

“No es probable que las directrices de la FDA obliguen a los fabricantes a medir el rendimiento de sus dispositivos en pacientes con mala perfusión. Por lo tanto, estos esfuerzos de la FDA podrían generar las condiciones para que los dispositivos funcionen correctamente en adultos sanos de piel oscura pero no creemos que logren solucionar el problema”, opinó Hugh Cassiere, que preside un panel del Comité Asesor de Dispositivos Médicos de la FDA, en una reunión del organismo en febrero.

Un historial de inacción

Aunque algunos estudios recientes que patrocinó la industria han demostrado que ciertos dispositivos funcionan correctamente en los distintos tonos de piel, investigaciones que se remontan a la década de 1980 han detectado discrepancias en la oximetría de pulso.

En 2005, Bickler y otros científicos del Laboratorio de Hipoxia publicaron pruebas de que tres de los principales dispositivos no detectaban de forma sistemática la hipoxemia (bajo nivel de oxígeno en sangre) en pacientes con pigmentación oscura, sobre todo en los que presentaban una grave falta de oxígeno. Tras señalar que estas lecturas podían ser cruciales para orientar el tratamiento, los autores pidieron que los oxímetros llevaran un alerta que advirtiera sobre esta dificultad.

La respuesta de la FDA fue poco significativa. La normativa que regula los oxímetros de pulso autoriza su venta siempre que demuestren una “equivalencia sustancial” con los dispositivos ya comercializados.

En un borrador de un documento orientativo de 2007, la FDA sugería que las pruebas de los nuevos oxímetros podían “incluir un número suficiente de sujetos con pigmentación oscura de la piel, por ejemplo, el 30%”. Sin embargo, la guía final, publicada en 2013, recomendó “al menos 2 sujetos con pigmentación oscura o el 15% de su grupo de personas, lo que sea mayor”. Los estudios debían tener solo 10 individuos. Y la agencia no definió “pigmentación oscura”.

Las pruebas de los dispositivos consisten en colocar a los pacientes máscaras que controlan los gases que respiran, al tiempo que se toman lecturas de oximetría de pulso y muestras de sangre arterial que se introducen en un dispositivo de medición de gran precisión, inventado por el difunto fundador del Laboratorio de Hipoxia, John Severinghaus.

Bickler, que cuando habla de las decenas de dispositivos que ha probado su laboratorio exhibe el irónico escepticismo de un avezado mecánico de automóviles, dijo que “no siempre se puede confiar en lo que dicen los fabricantes”.

Sus datos, aseguró, oscilan entre “completamente inexactos” y “obtenidos en condiciones absolutamente ideales, nada que ver con lo que sucede en el mundo real”.

Durante la pandemia, una organización médica benéfica se puso en contacto con el laboratorio para donar miles de oxímetros a países pobres. Los oxímetros que había elegido “no eran muy buenos”, explicaron. Después de eso, el laboratorio creó su propia página de calificaciones, una especie de Consumer Reports para oxímetros de pulso.

Según sus pruebas, algunos dispositivos costosos no funcionan con precisión; unos pocos aparatos de $35 son más eficaces que otros que cuestan $350. Según el sitio, más de un tercio de los dispositivos comercializados que ha probado el laboratorio no cumplen las normas actuales de la FDA.

Para investigar si las pruebas de los oxímetros en condiciones reales son viables, la FDA financió un estudio de la UCSF que ha reclutado a unos 200 pacientes en terapias intensivas. Los datos del estudio se están preparando para ser sometidos a una revisión de pares, con vistas a su publicación, según Bickler.

Bickler explicó que el laboratorio no calentó las manos de los pacientes antes de hacerles el estudio, una práctica habitual entre los fabricantes cuando prueban sus dispositivos. Dar calor a las manos asegura una mejor circulación en el dedo en donde se coloca el oxímetro.

“Afecta la relación señal/ruido”, afirma Bickler. “¿Recuerdas cuando las radios de los coches tenían emisoras AM y se oía mucha estática? Eso es lo que hace una perfusión deficiente: provoca ruido o estática que puede ocultar una señal clara del dispositivo”.

Los científicos del Laboratorio de Hipoxia —y los médicos que atienden en el mundo real— no calientan las manos de los pacientes. Pero “la gente de la industria no se pone de acuerdo sobre cómo manejarlo”, dijo.

Masimo, una empresa que dice tener los oxímetros de pulso más precisos del mercado cumpliría gustosamente cualquier directriz de la FDA, afirmó en una entrevista Daniel Cantillon, director médico de la compañía.

¿Cuánto cuesta solucionar el problema?

Los mejores dispositivos, según el Laboratorio de Hipoxia, cuestan $6.000 o más. Esto agrega otro problema.

Con oxímetros más precisos, “se va a reducir el acceso de los pacientes a los dispositivos porque una gran proporción de las personas simplemente no puede permitírselos”, dijo Lipnick.

Aunque la FDA no pueda complacer a todos, el requisito de incluir a más personas de piel oscura en las pruebas de oximetría “garantizará que haya una verdadera diversidad en el desarrollo y en las pruebas de esos dispositivos antes de que lleguen al mercado”, afirmó Lipnick. “Ese estándar ha sido demasiado bajo durante décadas”, agregó.

Es difícil evaluar el daño que puede causar en las personas las lecturas erróneas de los oxímetros, porque estos errores suelen ser un factor más en una cadena de incidentes. Pero estudios realizados en la Universidad Johns Hopkins y en otros centros indican que los pacientes a los que no se les detectó falta de oxígeno —posiblemente miles de personas— sufrieron demoras en el tratamiento y obtuvieron resultados más desfavorables.

Según Aboelata, algunos fabricantes, Zewa Medical Technology, Veridian Healthcare y Gurin Products, ya han respondido a la demanda de Roots Community Health incluyendo advertencias sobre las limitaciones de sus dispositivos.

No hay mucho que ella y otros médicos puedan hacer en la práctica diaria, dijo, aparte de establecer una lectura de referencia con cada nuevo paciente y estar atentos a consecuencias significativas.

Los hospitales tienen otras herramientas para medir los niveles de oxígeno, pero las lecturas correctas de los oxímetros son fundamentales para la atención ambulatoria, añadió.

En 2022, Connecticut promulgó una ley que prohíbe a las aseguradoras denegar la provisión de oxígeno a domicilio y otros servicios que se basan en las lecturas de la oximetría de pulso.

Pero “adaptarse a un dispositivo de mala calidad no es la solución”, aseguró Theodore Iwashyna, profesor de la Escuela de Salud Pública Bloomberg de Johns Hopkins y coautor del artículo del New England Journal of Medicine. “La solución es trabajar con un dispositivo menos inexacto”.

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Clinicians and scientists denounced the message as politically fueled scaremongering that also weakens efforts to protect against diseases like measles and whooping cough.

A prominent Florida doctor expressed dismay that medical leaders in the state, leery of angering Gov. Ron DeSantis, have been slow to counter anti-vaccine messages from Surgeon General Joseph Ladapo, including the latest covid bulletin. Ladapo is a DeSantis appointee and the top official at the state health department.

The bulletin makes a number of false or unproven claims about the efficacy and safety of mRNA-based covid vaccines by Pfizer and Moderna, including that they could threaten “the integrity of the human genome.” Florida’s guidance generally regurgitates ideas from anti-vaccine websites, said John Moore, a professor of microbiology at Weill Cornell Medicine.

Ladapo did not respond to a request for comment. DeSantis referred questions to the health department, which said the surgeon general’s guidance and citations “speak for themselves” and pointed to a post he made on the social platform X accusing the Centers for Disease Control and Prevention and FDA of “gaslighting Americans.”

DeSantis has styled himself and his administration as a bulwark against vaccine mandates, lockdowns, and other restrictive public health protections adopted during the pandemic to curb infections and save lives. Covid vaccination has become a partisan issue, with surveys by KFF, the health information nonprofit that includes KFF Health News, finding that Republicans have far less confidence in the safety and efficacy of the shots than Democrats.

But vaccine historians consulted for this article could not recall any previous state health leader urging residents to shun an FDA-approved and CDC-recommended vaccination. “It’s unprecedented,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Florida medical leaders should speak out more forcefully against Ladapo’s attacks on public health, said Jeffrey Goldhagen, a pediatrician and professor at the University of Florida College of Medicine in Jacksonville. Ladapo urged people under 65 to avoid covid shots last year and has rejected public health protocols for fighting measles outbreaks.

“What you see is a pattern of fear and neglect of professional responsibilities across the state, in part because of the fear of this governor and the vindictiveness of this governor,” said Goldhagen, a former health department director in Jacksonville.

He specifically criticized the Florida Medical Association, a trade group for physicians, noting that Ladapo is a nonvoting member of the group’s board of governors. The association did not respond to emails requesting comment.

The Florida Health Care Association, whose members run more than 600 long-term care facilities, declined to comment on Ladapo’s bulletin. One nursing home chain, LeadingAge Southeast, said it was aware of both federal and state recommendations on covid boosters and encouraged providers to “engage with their residents, families, and healthcare professionals to make informed decisions.”

A spokesperson for the U.S. Food and Drug Administration, Cherie Duvall-Jones, said the agency “strongly disagrees with the State Surgeon General of Florida’s characterization of the safety and effectiveness of the updated mRNA COVID-19 vaccines.” The vaccines met the FDA’s “rigorous, scientific standards,” she said, and she urged people to get boosters since the population’s covid immunity has waned.

Among its incorrect claims, the Florida bulletin says the new mRNA boosters wrongly target a viral variant, omicron, that is no longer circulating widely. This is false, since all major variants of covid in the past two years evolved from omicron and subsequent mutations.

“You start off with that and then you go into head-exploding-emoji territory,” Moore said. “It’s a litany of lies out of the anti-vaxxer playbook.”

Other claims in Ladapo’s bulletin include:

• Covid boosters don’t undergo clinical trials. It’s true that covid booster shots, whose mRNA sequences are changed slightly from previous shots, aren’t tested in large trials. Neither are annual influenza vaccines. By the time such tests would be completed, flu season would be over. But the original mRNA shots underwent clinical trials, and as with flu shots, “a lot of evidence has been collected in support of the ongoing use of the vaccines,” said Natalie Dean, a biostatistician at Emory University’s Rollins School of Public Health.
• The shots pose a risk of infections, autoimmune disease, and other conditions. “I don’t know where these claims come from, but they aren’t accepted by the general medical community,” said William Schaffner, a Vanderbilt University School of Medicine infectious disease specialist. Serious side effects do occur, rarely, as with any medication. U.S. authorities were among the first to detect rare occurrences of myocarditis, an inflammation of the heart tissue, in young adults who got the covid vaccine. Most patients recovered quickly. Myocarditis is more commonly caused by covid infection itself.
• The shots could cause elevated levels of spike protein and foreign genetic material in the blood. These concerns, which circulate on social media, have been disproved or have not panned out. For example, the billionths-of-a-gram quantities of bacterial DNA alleged to be contaminating covid shots are dwarfed by our other exposures, Offit said. “You encounter foreign DNA all the time, assuming you live on the planet and eat anything made from animals or vegetables,” he said. “I don’t know Dr. Ladapo, but I assume he does.”
• Americans face “unknown risk” from too many booster shots. Scientists look at the possibility of “overvaccination” every time they study boosters. So far, no safety risks have been associated with multiple immunizations, Schaffner said.
• Floridians should get exercise and eat vegetables and “healthy fats.” “These things will benefit your general health, but none of them will prevent covid,” Schaffner said.

The bulletin urges all Floridians, including older residents, to avoid mRNA vaccines and find alternatives. But it comes off as “not in good faith” because it doesn’t specifically mention the only non-mRNA vaccine available, from Novavax, Dean said.

Several critics of Ladapo’s bulletin said it read like a tryout for a job in a Trump administration advised by longtime anti-vaccine activist Robert F. Kennedy Jr., who has said Trump wants him to help vet senior health officials. Trump has said children receive too many vaccines and suggested that vaccines cause autism, a myth debunked by years of scientific research.

Ironically, although his administration oversaw the triumphantly rapid creation of the first covid vaccines, Trump declined to receive his shots in public, as presidents have done during past epidemics.

Ladapo’s vaccine statement “aligns with Project 2025,” Offit said, referring to the conservative Heritage Foundation policy blueprint. While the plan’s authors include officials from Trump’s first term, he has said it doesn’t reflect his views.

The document calls the CDC “perhaps the most incompetent and arrogant agency in the federal government.”

Organized resistance to vaccines has existed as long as vaccination itself. Within six months of the release of the mRNA vaccines in December 2020, about 70% of American adults were vaccinated. Those who refused put themselves at greater risk of hospitalization or death if they contracted covid, studies have shown.

Cheryl Holder, an internist who practices in Miami, said Ladapo’s statements had dampened interest in vaccination overall. People who are blasé about covid “also don’t want to take the tetanus vaccine, and they don’t want to take the pneumococcal vaccine, or the flu vaccine,” she said.

“We’re in the disinformation age,” Offit said. “It’s certainly a lucrative business, more lucrative than the information business. But what really bothers me is when you have people who are credentialed stand up and say these ridiculous things.”

Ladapo, he noted, has medical and doctoral degrees from Harvard.

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Clínicos y científicos denuncian este mensaje como una táctica de miedo con motivación política que también debilita los esfuerzos para proteger contra enfermedades como el sarampión y la tos ferina.

Un destacado médico de Florida expresó su consternación por el hecho de que los líderes médicos del estado, temerosos de enfurecer al gobernador Ron DeSantis, hayan sido lentos para contrarrestar los mensajes antivacunas del cirujano general Joseph Ladapo, incluido el último boletín sobre covid.

Ladapo fue nombrado por DeSantis y es el principal funcionario del departamento de salud estatal.

El boletín contiene una serie de afirmaciones falsas, o no comprobadas, sobre la eficacia y seguridad de las vacunas contra covid basadas en ARNm de Pfizer y Moderna, diciendo cosas tales como que podrían amenazar “la integridad del genoma humano”.

En general, la guía de Florida repite ideas de sitios de internet antivacunas, dijo John Moore, profesor de microbiología en Weill Cornell Medicine.

Ladapo no respondió a una solicitud de comentarios. DeSantis remitió las preguntas al departamento, que dijo que las directrices y citas del cirujano general “hablan por sí mismas” y señaló un post suyo en la plataforma X acusando a los Centros para el Control y Prevención de Enfermedades (CDC) y la Administración de Drogas y Alimentos (FDA) de “engañar a los estadounidenses”.

DeSantis se ha presentado a sí mismo y a su administración como un baluarte contra los mandatos de vacunas, los confinamientos y otras protecciones de salud pública restrictivas adoptadas durante la pandemia para frenar las infecciones y salvar vidas.

La inmunización contra covid se ha convertido en un tema partidista, con encuestas de KFF, la organización de información sobre salud que incluye KFF Health News, que muestran que los republicanos tienen mucha menos confianza en la seguridad y eficacia de las vacunas que los demócratas.

Pero historiadores de las vacunas consultados para este artículo no recordaron ningún líder de salud estatal anterior que instara a los residentes a rechazar una vacuna aprobada por la FDA y recomendada por los CDC. “Es algo sin precedentes”, dijo Paul Offit, director del Centro de Educación sobre Vacunas del Hospital Infantil de Philadelphia.

Líderes médicos de Florida deberían pronunciarse más enérgicamente contra los ataques de Ladapo a la salud pública, dijo Jeffrey Goldhagen, pediatra y profesor en la Facultad de Medicina de la Universidad de Florida en Jacksonville.

El año pasado, Ladapo instó a las personas menores de 65 años a no vacunarse contra covid, y ha rechazado los protocolos de salud pública para combatir brotes de sarampión.

“Lo que ves es un patrón de miedo y negligencia de las responsabilidades profesionales en todo el estado, en parte debido al temor a este gobernador y a su espíritu de venganza”, dijo Goldhagen, ex director del Departamento de Salud en Jacksonville.

Criticó específicamente a la Asociación Médica de Florida, un grupo comercial para médicos, señalando que Ladapo es miembro sin derecho a voto de la junta de gobernadores del grupo. La asociación no respondió a correos electrónicos solicitando comentarios.

La Asociación de Atención Médica de Florida, cuyos miembros administran más de 600 centros de atención de largo plazo, se negó a comentar sobre el boletín de Ladapo. Una cadena de hogares de adultos mayores, LeadingAge Southeast, dijo que estaba al tanto de las recomendaciones federales y estatales sobre los refuerzos de covid y alentó a los proveedores a “involucrarse con sus residentes, familias y profesionales de salud para tomar decisiones informadas”.

Cherie Duvall-Jones, vocera de la FDA, dijo que la agencia “está en fuerte desacuerdo con la caracterización del cirujano general de Florida sobre la seguridad y eficacia de las vacunas actualizadas de ARNm contra COVID-19”.

Las vacunas cumplieron con los “rigurosos estándares científicos” de la FDA, dijo, y exhortó a las personas a recibir refuerzos ya que la inmunidad de la población contra covid ha disminuido.

Entre sus afirmaciones incorrectas, el boletín dice que los nuevos refuerzos de ARNm atacan una variante viral, ómicron, que ya no circula ampliamente. Esto es falso, ya que todas las variantes principales de covid en los últimos dos años evolucionaron a partir de ómicron y mutaciones posteriores.

“Empiezas con eso y luego te adentras en territorio de ‘emojis con la cabeza explotando’”, dijo Moore. “Es una letanía de mentiras sacadas de un manual antivacunas”.

Otras afirmaciones en el boletín de Ladapo incluyen:

• Los refuerzos de la vacuna contra covid no se prueban en ensayos clínicos. Es cierto que las dosis de refuerzo de la vacuna contra covid, cuyas secuencias de ARNm se modifican ligeramente en comparación con las dosis anteriores, no se prueban en ensayos clínicos a gran escala. Tampoco se prueban las vacunas anuales contra la gripe. Para cuando estas pruebas estuvieran completas, la temporada de gripe ya habría terminado. Sin embargo, las vacunas originales de ARNm sí pasaron por ensayos clínicos y, al igual que con las vacunas contra la gripe, “se ha recopilado mucha evidencia que respalda el uso continuo de las vacunas”, dijo Natalie Dean, bioestadística en la Escuela de Salud Pública Rollins de la Universidad Emory.
• Las vacunas presentan un riesgo de infecciones, enfermedades autoinmunes y otras afecciones. “No sé de dónde vienen estas afirmaciones, pero no son aceptadas por la comunidad médica en general”, dijo William Schaffner, especialista en enfermedades infecciosas de la Facultad de Medicina de la Universidad Vanderbilt. Los efectos secundarios graves ocurren, raramente, como con cualquier medicamento. Las autoridades estadounidenses fueron de las primeras en detectar casos raros de miocarditis, una inflamación del tejido cardíaco, en adultos jóvenes que recibieron la vacuna contra covid. La mayoría de los pacientes se recuperaron rápidamente. La miocarditis es causada con mayor frecuencia por la infección de covid en sí.
• Las vacunas podrían causar niveles elevados de proteína espiga y material genético extraño en la sangre. Estas preocupaciones, que circulan en las redes sociales, han sido refutadas o no han tenido fundamento. Por ejemplo, las cantidades de billonésimas de gramo de ADN bacteriano que supuestamente contaminan las vacunas contra covid son insignificantes en comparación con otras exposiciones, dijo Offit. “Encuentras ADN extraño todo el tiempo, asumiendo que vives en el planeta y comes cualquier cosa hecha de animales o vegetales”, dijo. “No conozco al Dr. Ladapo, pero asumo que él también lo hace”.
• Los estadounidenses enfrentan un “riesgo desconocido” por recibir demasiadas dosis de refuerzo. Los científicos examinan la posibilidad de una “sobre vacunación” cada vez que estudian los refuerzos. Hasta ahora, no se han asociado riesgos de seguridad con múltiples inmunizaciones, dijo Schaffner.
• Los floridanos deben hacer ejercicio y comer vegetales y “grasas saludables”. “Estas cosas beneficiarán tu salud general, pero ninguna de ellas previene covid”, dijo Schaffner.

El boletín insta a todos, incluidos los residentes mayores, a evitar las vacunas de ARNm y encontrar alternativas. Pero parece que “no es de buena fe” porque no menciona específicamente la única vacuna no basada en ARNm disponible, de Novavax, dijo Dean.

Varios críticos del boletín de Ladapo dijeron que parecía un ensayo para un puesto en una administración Trump, editado por el activista antivacunas de larga data Robert F. Kennedy Jr., quien ha declarado que Trump quiere que lo ayude a evaluar a los altos funcionarios de salud.

Trump ha dicho que los niños reciben demasiadas vacunas y sugirió que causan autismo, un mito desmentido por años de investigación científica.

Irónicamente, aunque su administración supervisó la creación rápida y triunfal de las primeras vacunas contra covid, Trump se negó a recibir sus vacunas en público, como lo han hecho otros presidentes durante epidemias pasadas.

La declaración de Ladapo sobre las vacunas “se alinea con el Proyecto 2025”, dijo Offit, refiriéndose al plan de políticas de la conservadora Fundación Heritage. Aunque los autores del plan incluyen funcionarios del primer mandato de Trump, él ha dicho que no refleja sus puntos de vista.

El documento califica a los CDC como “tal vez la agencia más incompetente y arrogante del gobierno federal”.

La resistencia organizada a las vacunas ha existido desde que existe la vacunación. Durante los seis meses posteriores al lanzamiento de las vacunas de ARNm en diciembre de 2020, aproximadamente el 70% de los adultos estadounidenses estaban vacunados. Aquellos que se negaron se pusieron en mayor riesgo de hospitalización o muerte si contraían el coronavirus que causa covid, según han demostrado los estudios.

Cheryl Holder, internista que ejerce en Miami, dijo que las declaraciones de Ladapo habían causa una baja en el interés general en las vacunas. Las personas que son indiferentes a covid “tampoco quieren ponerse la vacuna contra el tétanos, ni la vacuna neumocócica, ni la vacuna contra la gripe”, dijo.

“Estamos en la era de la desinformación”, dijo Offit. “Ciertamente es un negocio lucrativo, más lucrativo que el negocio de la información. Pero lo que realmente me molesta es cuando personas con credenciales se paran y dicen estas cosas ridículas”.

Destacó que Ladapo tiene el título médico y doctorados de la Universidad de Harvard.

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