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Las garrapatas migran y aumentan los riesgos de enfermedades si no se las rastrea con rapidez

El biólogo Grant Hokit llegó a una pradera en las montañas de Condon, Montana, en busca de garrapatas. Un sendero cruzaba el campo lleno de pasto alto y arbustos con bayas.

El biólogo Grant Hokit llegó a una pradera en las montañas de Condon, Montana, en busca de garrapatas. Un sendero cruzaba el campo lleno de pasto alto y arbustos con bayas.

Mientras caminaba por el sendero, Hokit cargaba una herramienta hecha a mano con tubos de plástico pegados entre sí que sostenían un enorme rectángulo de franela blanca.

Se burlaba de lo “sofisticado” de su dispositivo, pero el estudio científico era muy serio: pasaba la tela por encima de los arbustos y la hierba, con la esperanza de que las garrapatas se agarraran a ella.

Durante el verano, estas garrapatas cuelgan de las hojas, estirando sus patas mientras esperan que pase un mamífero.

“Tenemos una”, dijo Hokit.

“Esta salió de este arbusto”, explicó. “Al resto simplemente las recogemos con los dedos. Tenemos un frasquito donde las guardamos”.

Las garrapatas capturadas irán al laboratorio de Hokit en Helena, la capital del estado, para ser identificadas. La mayoría probablemente será clasificada como “garrapatas de la madera” de las Montañas Rocosas.

Pero Hokit también quería saber si han llegado nuevas especies al estado.

El cambio climático provocado por los humanos ha acortado los inviernos, lo que hace que las garrapatas pasen menos tiempo en hibernación y tengan más meses de actividad para engancharse a animales y personas. A veces, las garrapatas se trasladan —junto con las enfermedades que acarrean— a nuevas regiones del país.

Este año, Hokit encontró por primera vez garrapatas del ciervo (o garrapatas de patas negras) en el noreste de Montana. Esta especie es conocida por transmitir la enfermedad de Lyme, y también puede infectar a las personas con otros patógenos.

Saber que una nueva especie como la garrapata del ciervo ha llegado a Montana y a otros estados es muy importante para los médicos.

Neil Ku, especialista en enfermedades infecciosas en Billings Clinic, en el este de Montana, explicó que la mayoría de los pacientes no van al médico justo después de haber sido picados por una garrapata.

Por lo general, buscan atención más tarde, cuando ya se sienten enfermos por una enfermedad transmitida por estos parásitos.

“Fiebre, escalofríos, simplemente se sienten mal, como sucede con muchas infecciones que pueden presentarse a lo largo del año”, señaló.

Es poco común que las personas relacionen esos síntomas con una picadura de garrapata, y aún más raro que conserven la garrapata que los picó. Por eso, identificar si alguien tiene una enfermedad transmitida por garrapatas puede ser complicado.

Conocer qué tipos de garrapatas hay en una región ayuda a los médicos a identificar enfermedades nuevas relacionadas con estas picaduras, dijo Ku.

Esa es una de las razones por las que el estado busca nuevas especies de garrapatas.

“Cuanto más sepamos sobre lo que hay en Montana, mejor podremos informar a los médicos y mejor atención podrán brindar”, afirnó Devon Cozart, epidemióloga del Departamento de Salud Pública y Servicios Humanos de Montana, especializada en enfermedades zoonóticas transmitidas por vectores (infecciones que se propagan de animales a humanos a través de garrapatas o mosquitos que pican a un animal infectado y luego a una persona).

Cozart recolecta y analiza las garrapatas obtenidas en los estudios de campo en Montana para detectar si portan algún patógeno.

La capacidad de una garrapata para enfermar a una persona depende de la especie, pero también influye el tipo de mamífero del que se alimenta.

“Por lo general es un roedor que puede portar, por ejemplo, la fiebre maculosa de las Montañas Rocosas”, explicó. “Entonces la garrapata se alimenta de ese roedor y adquiere el patógeno”.

Como la presencia de una enfermedad puede variar según la población de mamíferos, las garrapatas en una parte del estado pueden representar más, o menos, riesgo para las personas. Esta también es información relevante para los profesionales de salud, agregó Cozart.

Este tipo de vigilancia y análisis no se hace en todos los condados ni en todos los estados. Una encuesta de 2023, realizada a casi 500 departamentos de salud en el país, halló que apenas una cuarta parte lleva a cabo algún tipo de monitoreo de garrapatas.

No todas las tareas de vigilancia son iguales, dijo Chelsea Gridley-Smith, directora de salud ambiental en la Asociación Nacional de Funcionarios de Salud de Ciudades y Condados.

Los estudios de campo pueden ser costosos. Por eso, muchos departamentos de salud estatales y locales dependen de un enfoque más económico y pasivo: pacientes preocupados, veterinarios y médicos deben recolectar y enviar las garrapatas para su identificación.

“Eso da un poco de información sobre qué garrapatas están en contacto con personas y animales, pero no permite conocer lo comunes que son en determinada zona ni con qué frecuencia portan patógenos”, explicó Gridley-Smith.

Agregó que más departamentos de salud quieren empezar a vigilar a las garrapatas, pero conseguir financiamiento es difícil. Y podría volverse aún más complicado si se reducen los fondos federales para salud pública, como los que otorgan los Centros para el Control y Prevención de Enfermedades (CDC).

Montana recibe unos $60.000 al año a través de una subvención federal, pero la mayor parte de ese dinero se destina a la vigilancia de mosquitos, que es más intensiva y costosa. Lo que queda se utiliza para realizar salidas en busca de garrapatas.

Hokit comentó que no cuenta con suficiente financiamiento para que su pequeño equipo pueda hacer estudios en todo el estado, que es muy extenso. Eso significa que no puede monitorear de cerca las poblaciones emergentes de garrapatas del ciervo como quisiera.

Encontró estas nuevas garrapatas en dos condados de Montana, pero no tiene suficientes datos para determinar si ya están reproduciéndose allí y formando una población local.

Mientras tanto, Hokit usa datos sobre el clima y la vegetación para predecir en qué zonas del estado podrían prosperar estas garrapatas. Está observando áreas específicas del oeste de Montana, como Flathead Valley.

Dijo que eso ayudará a su equipo a enfocar la búsqueda y a informar al público cuando lleguen las garrapatas del vciervo y las enfermedades que pueden transmitir.

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KFF Health News' 'What the Health?': Ousted CDC Officials Clap Back at RFK Jr.

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Julie Rovner
KFF Health News


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Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.

Fired less than a month after being confirmed as head of the Centers for Disease Control and Prevention, Susan Monarez appeared at a dramatic Senate hearing this week alongside another ousted CDC official and directly contradicted Health and Human Services Secretary Robert F. Kennedy’s earlier testimony about why she was fired.

Monarez told the Health, Education, Labor, and Pensions Committee that Kennedy ordered her to agree to approve changes to the childhood vaccine schedule soon to be recommended by a CDC advisory panel, regardless of scientific evidence, and to fire senior career scientists who the secretary felt did not share his vaccine views.

Meanwhile, Republicans and Democrats in Congress are at a standoff over government funding, with less than two weeks to go before a potential shutdown. Democrats — whose votes are required to pass a bill in the Senate — say they won’t vote to keep the government open unless Republicans agree to extend expanded subsidies for Affordable Care Act insurance plans that otherwise expire at the end of the year. Republicans are so far resisting those calls, although some are concerned that the resulting premium spikes would affect their own voters.

This week’s panelists are Julie Rovner of KFF Health News, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico Magazine, Alice Miranda Ollstein of Politico, and Margot Sanger-Katz of The New York Times.

Panelists

Joanne Kenen
Johns Hopkins University and Politico


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Alice Miranda Ollstein
Politico


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Margot Sanger-Katz
The New York Times


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Read Margot's stories.

Among the takeaways from this week’s episode:

  • Sen. Bill Cassidy (R-La.) — who, as chairman of the HELP Committee, called the hearing and is a gastroenterologist — found himself pushing back on some of his GOP colleagues, particularly on the importance of vaccinating newborns against hepatitis B. Cassidy, who is up for reelection next year and faces a primary challenge, is in a delicate position regarding the oversight of the Trump administration’s health policies.
  • The hearing showcased broad, across-the-aisle agreement that trust in the CDC has eroded — along with a stark divide over the cause and who’s at fault. Democrats point at Kennedy and the Trump administration, while Republicans blame the agency’s handling of the covid-19 pandemic. Historically, Americans have tended to trust public health officials; now, states are starting to create a patchwork of policies.
  • Congress is struggling to agree on even a stopgap measure to keep the federal government funded, increasing the chances of a government shutdown on Oct. 1. Democrats are pushing to extend enhanced federal ACA subsidies as part of a deal, but that issue could be kicked down the road, injecting uncertainty into this year’s open enrollment process, which begins Nov. 1.
  • And more details are emerging about the $50 billion rural health fund inserted at the eleventh hour into Trump’s major domestic policy law. As the federal government begins soliciting applications for funding from states, it’s becoming clear that there are strings attached — and that the funding isn’t entirely designated for rural hospitals after all.

Also this week, Rovner interviews Troyen Brennan, former chief medical officer at Aetna and CVS, on his new book about primary care, “Wonderful and Broken: The Complex Reality of Primary Care in the United States.”

Plus, for “extra credit,” the panelists suggest health policy stories they read (or wrote) this week that they think you should read, too: 

Julie Rovner: The New York Times Magazine’s “Trump Is Shutting Down the War on Cancer,” by Jonathan Mahler.  

Margot Sanger-Katz: ProPublica’s “Programs for Students With Hearing and Vision Loss Harmed by Trump’s Anti-Diversity Push,” by Jodi S. Cohen and Jennifer Smith Richards.  

Alice Miranda Ollstein: The New York Times’ “I Have Dental Insurance. Why Do I Pay So Much for Care?” by Erica Sweeney.  

Joanne Kenen: Politico Magazine’s “Why Voters Will Feel the Impact of GOP Health Cuts Before the Midterms,” by Joanne Kenen.  

Also mentioned in this week’s podcast:

Click to open the transcript

Transcript: Ousted CDC Officials Clap Back at RFK Jr.

[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It has been edited for style and clarity.] 

Julie Rovner: Hello, and welcome back to “What the Health?” I’et cetm Julie Rovner, chief Washington correspondent for KFF Health News, and I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, Sept. 18, at 10:30 a.m. As always, news happens fast, and things might’ve changed by the time you hear this. So here we go. 

Today, we are joined via video conference by Alice Miranda Ollstein of Politico. 

Alice Miranda Ollstein: Hello. 

Rovner: Margot Sanger-Katz of The New York Times. 

Margot Sanger-Katz: Good morning, everybody. 

Rovner: And Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico Magazine. 

Joanne Kenen: Hi, everyone. 

Rovner: Later in this episode, we’ll have my interview with Troyen Brennan of the Harvard T.H. Chan School of Public Health, who has a brand-new book out on the past and future of primary care, aptly called “Wonderful and Broken.” But first, this week’s news.  

So, ousted director of the Centers for Disease Control and Prevention Susan Monarez testified before the Senate HELP [Health, Education, Labor, and Pensions] Committee on Wednesday, and the hearing did not lack for drama. As she wrote earlier this month in The Wall Street Journal, Monarez disputed HHS [Department of Health and Human Services] Secretary Robert F. Kennedy Jr.’s account of what led to her firing and repeated that she was asked to “rubber-stamp” whatever changes the secretary’s handpicked vaccine advisory committee suggests at their meeting, which is starting just as we tape today. Monarez also told the committee she was ordered to fire senior career people who were not aligned with the secretary’s anti-vaccine views. 

But unlike last week’s hearing with RFK Jr., which was before the Finance, not the HELP, Committee, this hearing, with few exceptions, was a lot more partisan, with Republicans who literally just voted to confirm Monarez in July trying to undermine her credibility and Democrats apologizing for doubting her integrity. We’ll talk about HELP Chairman Dr.-Sen. Bill Cassidy separately in a second. But this hearing struck me as evidence that most Republicans are still firmly supporting RFK Jr., at least for now. Is that the impression that you guys got? You all watch the hearing, too? 

Ollstein: Yeah, I was in the room. There was an interesting divide among Republicans. I mean, Democrats were pretty uniformly outraged about what was happening, praising Monarez for attempting to stand up to Kennedy even if that cost her job. Some Democrats even apologized for doubting her and said, “When you came for your confirmation hearing, I was really tough on you. I wasn’t sure you were going to stand up to Kennedy, but you proved me wrong. You did,” which I thought was interesting. And then on the Republican side, you had the folks you would kind of expect — Susan Collins, Lisa Murkowski — expressing concern about the implications for public health, asking Monarez what happened and who said what and who made what decision. 

And Cassidy was in that camp as well, and Cassidy even, at multiple points, pushed back on his own Republican colleagues. He did that on this issue of whether or not there was a secret recording, which we can talk about. He did that on just the basic science of the hepatitis B vaccine. He used his own medical credentials to say, “Look, I know what I’m talking about. The recommendation that newborns get vaccinated for hepatitis B is a good one.” And this was with Rand Paul, who’s also a physician, but doesn’t specialize in hepatitis like Bill Cassidy does, was sort of fact-checking that. 

Rovner: Yes. Rand Paul’s an ophthalmologist, just for the record. 

Ollstein: Right, right. And so there were some really interesting moments with that divide in the GOP. 

Rovner: I thought to a little bit of an extent, and I know I’m jumping ahead here, Cassidy kind of threw Monarez under the bus because it looked like several of the Republicans had the same talking points, accusing her of having tried to banish the political appointees from her suite of offices — things that had not, I went searching around for, gee, is there some story that I missed and I didn’t find anything. I’m sure that there was something there. But Cassidy, he was responsible for bringing her in — and we should say Debra Houry, who was one of the senior people who quit after Monarez was fired. Cassidy brought them both there and then let some of his colleagues run roughshod over them. 

Kenen: Yeah, but he also — I thought he dropped some hints of support. You’re right, he didn’t embrace her, but he kept saying, “We have to hear from the secretary, too.” But the fact that he really ended it on such a “I’m a doctor and I know,” I thought that was a very validating thing for her in a way. Then, when we get to the mystery tape, he said one thing that if you were paying careful attention was quite interesting, potentially helping her. 

Rovner: Let’s talk about the mystery tape. This was Sen. Markwayne Mullin from Oklahoma, who was, I guess, you would say, the most hostile questioner basically. 

Kenen: Well, [Ashley] Moody, what was her name? The last hour was bonkers. 

Rovner: Yeah. So anyway, so Mullin basically accused Monarez of lying about what happened in the meeting with her and the secretary, where she says she was told to basically pre-rubber-stamp the ACIP recommendations, and Kennedy said he asked her if she was trustworthy, and she said no. And Mullin said that this meeting was recorded, and I think you’re not telling the truth. And then, apparently — I was not there, Alice, you were — when we went out into the hallway to vote, he said, “Well, maybe it wasn’t recorded.” And then all hell broke loose. 

Kenen: It was six minutes. I checked the time between the time when Cassidy said, “What tape?” And then when Cassidy then interrupted to say, “Oh, by the way, he’s now telling everybody there’s not a tape.” So what text did he get to remind him that he didn’t remember in those six minutes? 

Ollstein: We also got a statement from HHS saying there is no tape. The tape does not exist. So that’s the official word from the agency. That was a weird little — but I mean, I think it all goes back to the bigger tussle over how do we make this anything other than a “he said, she said.” I mean, we even had senators say we don’t want this to become a “he said, she said.” But in the absence of a tape or supporting documentation or other eyewitnesses, how are they going to get past “he said, she said”? 

I mean, clearly Monarez was trying to argue that they should believe her, but now they’re going to have Kennedy come back and give his rebuttal to her rebuttal. And so where does this end? Cassidy said that he had been requesting supporting documentation from HHS and hasn’t gotten it yet. So how do we get past this? 

Rovner: Well, but I want to talk about Cassidy because that’s where this all sort of hinges. I mean, you could see from the talking points of the more conservative Republicans that they clearly are taking RFK Jr.’s side of this in the “he said, she said.” Cassidy, as he has been since he voted reluctantly to confirm RFK Jr., kind of on both sides. At some point, does he have to fish or cut bait on this? 

Sanger-Katz: He’s in a very difficult political situation. I think the fact that he held this hearing is actually a little bit surprising and in some ways the most meaningful thing that happened. I mean, Congress would not have brought these people to come testify if not for him. I think almost certainly. And I think giving voice to these ousted officials at CDC, giving them an opportunity to tell their side of the story, represents new information and a new spotlight on these disputes within the CDC and HHS that we would otherwise not know about. 

But this was the week of profiles of Bill Cassidy as the man in the middle. And I do think he is in a very delicate position, where he is up for reelection. He is being primaried in his home state. He is not seen as being entirely loyal to the president. He voted for President [Donald] Trump’s impeachment, for conviction of an impeachment the second time around in the first Trump term. 

Rovner: After January 6th. 

Sanger-Katz: After January 6th, yeah. And yeah, I guess it was not his term anymore by the time he voted. But I mean, I think he is seen as maybe not fully MAGA, not fully loyal, and I think he’s worried about losing his job. On the other hand, he is a physician. I think he does care about vaccines. He certainly seems to care a lot about this hepatitis vaccine that he was pretty forthrightly defending at this hearing. 

And he clearly does not like everything that Kennedy stands for and is trying to achieve. And he tried to bridge that divide by obtaining a bunch of personal guarantees from Kennedy before he was confirmed, that he wasn’t going to do various things, that he was going to do various things. And I think the track record really shows that Kennedy has broken a lot of those promises. 

And so again, I just think this puts Cassidy in a difficult bind, where I think he does not seem like the kind of person who’s ready to really come out against the Trump administration and Secretary Kennedy. At the same time, I think he’s trying to find a way to stand up for some of these medical values that he’s held and express some minor disappointment that promises that were made have not been kept. 

But I think anyone who’s looking for him to suddenly break free and become extremely strident on these things is probably going to continue to be disappointed. 

Rovner: We can wait. Well, in the meantime, even as RFK Jr.’s newly reconfigured Advisory Committee on Immunization Practices meets, it seems more and more that CDC itself is losing its place as a source of trusted scientific advice. AHIP, the health insurance industry group, announced on Tuesday that its members would continue to cover vaccines recommended by AHIP as of Sept. 1, 2025, through 2026. 

Basically, whatever they decide at this meeting, we’re going to ignore. And, as we discussed last week, many states are bypassing CDC recommendations and going with their own health department rules for obtaining covid and other vaccines. The West Coast states made their consortium formal just this week. No matter what happens going forward, is CDC’s day as the nation’s trusted source of scientific advice over? 

Kenen: Well, it depends on who’s doing the trusting. It used to be that the country trusted the CDC. And now the new CDC, and we don’t know who it’s going to be or what they’re going to do, but it’ll be in the mold of Kennedy. We’re past the time, at least for now and hopefully not forever, when half the country trusted the CDC as it was and half the country has lost trust. 

So it’s going to flip. So you can’t even talk about the CDC being trusty without saying, for half of America, for those who watch certain TV stations. So it’s a whole different scenario about trust and distrust, unfortunately. Certain basic things are no longer shared values and beliefs. 

Rovner: Is it really half of America, or is it a very loud minority? 

Kenen: America’s a really distrustful country and has been for a really long time when you go back to what you thought was a more trustworthy era. No, we’ve been really a suspicious bunch for decades. But the division over the CDC and over public health and the messaging, it might not be 50-50, but it is bigger and bigger and bigger. It is not all completely hard-line. And just look what’s happening with vaccines. But that shows that this is eroding, right? 

It’s eroding deeply and fast, and it’s eroding from something that people assumed to be true and helpful and lifesaving in this 180[-degree] flip. So I just think unfortunately, no, I may have overspoken by 50-50, but it’s a lot of people, and we cannot talk about trust in this country the way we used to talk about trust in this country, other than maybe sports. It’s the only thing that people agree on, right? 

Rovner: It’s not even that always. Alice, want to say something? 

Ollstein: Yeah. So at the hearing yesterday, there was pretty broad agreement across the board about plummeting public trust in the CDC and health agencies, but they disagreed on who was to blame for that. And so you had Monarez and several senators saying, “Look, the things Kennedy has said about his own agency and workers, calling them corrupt, saying that they are responsible for deaths, etc., that is what is eroding trust.” 

And you had several conservative Republicans say, “No, what the CDC did during covid that is responsible for the eroding trust.” Now, Monarez was not the head of the CDC during covid, but they still tried to pin it on her. And you had senators even tell her, “You are the problem for the eroding trust,” which I thought was pretty interesting. 

Rovner: Yeah, I did too. 

Sanger-Katz: This feels to me almost like the culmination of polarization on these issues about trust in public health authorities and in vaccines, in particular. As Joanne said, historically, we were a suspicious country, but I don’t think there was a real partisan divide over these questions. There were certain people who were worried about vaccines, who were suspicious of public health advice generally, but I think overall Americans tended to trust public health authorities. 

And we started to see that breakdown during covid, where we saw more and more right-leaning Republican people who were suspicious of the public health advice, who felt like they were being misled or that it was politically motivated. And I think Kennedy and Trump have heightened that. 

There has been all of this messaging from the president, in particular from the health secretary, questioning the long-standing public health advice that the agencies have been giving people and telling them that they shouldn’t trust them and that there needs to be a major overhaul. But I think what we see now is left-leaning states basically freelancing and doing their own public health advice. 

And I think that furthers the sense that these central public health authorities a) are not to be trusted, and b) that there’s Republican public health message and a Democratic public health message. And I think we’ve seen this kind of polarization across lots of other areas of public policy and social values in our country over the last few decades. But this does feel to me new and starting to become a complete polarization about public health advice and who you should trust about the right way to stay healthy. 

That does seem like it could have pretty long-standing impacts in how people go about their lives, as there are threats and as there are ongoing drives to get people to get vaccinated and other things. 

Rovner: And I do, and I think this is all so accelerated just this year because HHS, for all its lots of controversy to cover — we’ve all covered HHS for a long time — most of HHS has been pretty apolitical, the general functioning of the CDC and the NIH [National Institutes of Health] and FDA [Food and Drug Administration] and CMS [Centers for Medicare & Medicaid Services]. I mean, you’ve got career people that have been there through multiple presidents of multiple parties and multiple administrators and multiple HHS secretaries, and it just hasn’t been that controversial. And now it feels like everything is highly controversial and loaded and polarized. But I did want to mention — 

Sanger-Katz: And partisan, like divided along the party lines in a way that I don’t think it was before. Yeah. 

Rovner: Right. I see so many career people who are just mystified and their heads are exploding. It’s like, this is not what I’ve been doing for 30 years, and this is not what I signed up to do. I did want to mention the poll out this week from The Washington Post and my own polling colleagues here at KFF that found that most parents do still support childhood vaccines, but that poll also found that 1 in 6 parents has delayed or skipped a vaccine for their children

And of those parents, they’re more likely to identify as white, religious, Republican and under 35, so younger and more partisan. At the same time, a data investigation by NBC News and Stanford University found that not only are vaccination rates falling in general, but in more than two-thirds of U.S. counties, the vaccine rate for the measles vaccine is under the 95% required for herd immunity. That’s what prevents outbreaks from spreading. When does this actually become a public health emergency or is it one already and the public just hasn’t noticed yet? 

Kenen: And the other thing about those numbers is they’re getting bigger fast. If you did that poll again in two months, I mean, the trajectory is sharp. The trust is just falling and falling. It’s not like itsy-bitsy. There are counties where childhood vaccine rates are now like 80, 82. It’s a cliché to us, but not to necessarily to all of our listeners, is that the problem with public health is like when it works, you don’t see it. And then you say, why do we need that, why should we pay for that? etc. It’s sort of the same thing for vaccines. When they work, these diseases have basically almost vanished and we’ve forgotten or we never know. 

Ollstein: They’re a victim of their own success. 

Kenen: Right. People don’t think, oh, measles actually kill you or leave you vulnerable with all sorts of other neurologic and other problems. Do most kids get better? Yes, but it’s a bad thing, something you should not want your child to have. And we’ve forgotten that. So the fear is that the only way we’re going to recognize their value is when it’s too late for some people who’ve already been hurt or died. 

And I won’t say that’s inevitable, but it’s on the table. This is a very real possibility. Now, we just had this huge outbreak in Texas. Two kids did die. And it was sort of like, well, it’s only two, or maybe it was something else, or et cetera, et cetera, et cetera. None of us want to see something terrible happen and yet something terrible could happen. 

Sanger-Katz: And also, measles is the most contagious of these childhood diseases for which we have historically had widespread vaccination. And so that means we’re going to see measles outbreaks the fastest. But, as Joanne said, measles is not the most dangerous of the diseases that we vaccinate children for. And so if you’re seeing 1 in 5, 1 in 6 parents skipping a vaccine, we will see it in measles outbreaks first. 

But a couple of cases of polio, you could end up with a very high percentage of children with very bad outcomes, and some of these other diseases really are more dangerous. So it really becomes a question of when some of these other diseases that have really, really bad outcomes start finding their way into these populations that are not vaccinated. And I think it’ll become immediately more clear that these vaccines are doing something important. 

Rovner: In other words, we’re going to have to learn the hard way. Moving on, as of this taping, we are 12 days away from a possible government shutdown if Congress doesn’t agree on a temporary spending bill, and it’s looking like they might run right up to the deadline, as usual. Democrats are still insisting that Republicans do something to extend expiring tax credits for Affordable Care Act insurance plans. Republicans continue to say no way, basically daring Democrats to shut the government down. How’s it looking as of Thursday morning? 

Ollstein: Well, we have competing CRs [continuing resolutions], which is never a good sign. You have the Republican CR that Democrats say is unacceptable, and now you have a Democrat CR. Either of these would just be kicking the can down the road just less than a couple months. So clearly they haven’t yet addressed the fundamental underlying disagreements, and now they can’t even agree on the stopgap. 

Rovner: There’s new numbers out from the CBO [Congressional Budget Office] this morning that we’re not going to talk about in-depth, but one of the things I did notice is that the Democrats are asking for the extension of these ACA credits, and one of the things that CBO said is that even if you do it by Sept. 30, you’re not going to get back all the people who are going to lose insurance because insurers aren’t going to necessarily lower their premiums. 

So I mean, this is going to happen no matter what, at this point. There’s going to be sticker shock. The question is how big the sticker shock is going to be. And the longer this debate goes, the harder it’s going to be to have any real impact on. I mean, so it’s not just keeping the government open, it’s like the future of the Affordable Care Act. 

Ollstein: A lot of the chaos is fueled by the fact that they’re kicking the can on resolving what’s going to happen with the ACA subsidies into the middle of open enrollment. And so what does that even mean? I have sources asking me how are plans going to respond? Are consumers going to be notified that the price is going to change? Can it even change? Or they have to pay the full price even if the subsidies come through? These things have to be worked out in advance, not in the middle of the process, but that’s where we are. 

Kenen: The rates haven’t all been finalized in all the states, and there’s also an appeals process. So you could end up with just this very messy prolonged rate-setting. I mean, if you’re an insurance plan and you’ve put in your rates high and this situation changes in terms of ACA subsidies, you might decide you want to come down because you’re afraid your competitor is going to come in — I mean, we don’t know how all that’s going to play out. It’s complicated and time-consuming. 

But yeah, a lot of people are going to hear this isn’t available anymore, and people don’t pay attention. We all get stuff from our health plan that we do not click on, and we are health reporters. So there’s going to be people who are entitled to things that don’t realize they’re entitled to things just as there are people who under the current scenario think they’re entitled to things and are going to get an unpleasant shock when they find out that they’re not. So it’s a whole lot of confusion. 

Rovner: I’ve been saying for the last couple of weeks that when are Republicans going to wake up and notice that these are going to be largely their constituents who are going to get this sticker shock? I mean, it’s in a lot — 

Kenen: Well, [Sen. Tommy] Tuberville [R-Ala.] said so yesterday. 

Rovner: Right, right. That’s what I was getting at. So we’re starting to see Republicans notice. Is it too late? Margaret, you wanted to say something? 

Sanger-Katz: Yeah. Well, there’s two things I wanted to say. One, to that point, I did a story last week with my colleague Catie Edmondson, who covers the Hill. And I actually think a lot of Republicans already know this. And I think it’s one of the reasons why it is interesting to me that this is the ask that the Democrats are making as part of their negotiations over the spending bill. 

I think there has been a lot of consternation among Democrats since the last spending fight, that they didn’t fight hard enough, that they didn’t stand up to Trump, that they didn’t shut down the government to prove a point. And they have a long list of grievances with the Trump administration, and their voters are upset about a lot of things. And there are a lot of fights that the Democrats could have chosen to pick and say, We will not fund the government unless … 

And I think we can imagine what many of those things could be, and some of them actually could be related to the budget itself, but that’s actually not what they chose here. What they basically chose is they said, We will fund the government if you do these health care subsidies. And then again, I want to come back to what have Republicans been saying about that? 

So I think there has actually been quite a lot of openness, a surprising amount of openness among Republicans, including quite conservative Republicans like Tuberville, to considering changes that would extend the subsidies. And we see in the House, 10 relatively vulnerable members sponsored legislation to extend the subsidies for one year. And then in the Senate, there’s almost a dozen members who either said, Yes, we should do this in some fashion or Anything’s on the table, I’m open to considering it

Now, that was, of course, before there was the standoff, but I do think that the Democrats are trying to put forward an offer that could result in a deal, which doesn’t mean that there won’t be a shutdown and it doesn’t mean that there won’t be a lot of negotiation, but there could be a deal, I think, on this. This was a choice that they made maybe to get a policy win and not to get maximum conflict. 

Rovner: Yeah. I mean, there are those who say that the Democrats shouldn’t do this because they should let the Republicans reap the whirlwind of what they did by not extending the subsidies when they could, should, would have, back in the summer when they did the big bill. 

Sanger-Katz: And I think potentially I’m sure there’s a cynical political calculation that would’ve said, OK, let them do it. Let them own it. We’ll run on the fact that everyone’s premiums went up and lots of people don’t have insurance anymore. I think they’re making a different choice here. They’re making a choice where they say, maybe we could get to a deal on this. If we can’t get to a deal on it, we’ll run on how the Republicans raised your insurance premiums. But we do see some kind of cracks in the armor. There are some Republicans who would like to do this. Maybe there’s an opportunity to work together.  

And then on the marketplaces, I just want to say I did a fair amount of reporting on this, talking to insurers and state officials and various other actors in this. I think the really crucial deadline to think about is Nov. 1. So that’s when open enrollment starts. We’re talking about a CR that needs to be passed by the end of this month in order to avoid a shutdown. 

Now again, we could get a shutdown. It certainly could be that these negotiations push out closer to that Nov. 1 deadline. But in general, Nov. 1 is when most people are going to go onto the website and start window-shopping and see what is insurance going to cost me? And while I think the insurer-calculated rates may be cooked by that point, they are probably not that important if the subsidies get extended. 

Because what the subsidies did is they provided financial assistance for almost everyone who buys their own insurance, such that they are not really vulnerable to changes in the overall price. And there are all these various mechanisms that can work it out on the back end. If there are no subsidies, then there really is this double whammy for consumers. A) premiums are going to be higher because the insurers think the risk pool is going to be worse. So they’ve increased prices around 4% to account for the fact that some healthier people are probably going to drop out. They’ve raised them a whole bunch more for other reasons that are unrelated to this. And b) people who were getting a plan for free are suddenly going to get a plan for 30, 50 bucks a month. People who were getting a heavily subsidized plan in some cases might have to pay hundreds of dollars more a month on that for the older, higher-income people. 

So if people come in Nov. 1 and they see suddenly my plan that was free is 50 bucks a month and I can’t afford that, I think those people may just not come back. I think that is really the concern that the insurers have that a lot of policymakers have, even if it gets worked out on the back end. 

But I think if they get a deal before Nov. 1, and when people go to the portal the first time, they see that their subsidies are subsidizing as much of their premium as they were expecting, I think there really could be an ability to mitigate some of the really big drop-offs in coverage and panic among consumers that the insurers and other policymakers are concerned about. 

Rovner: Well, we will continue to watch this space. I do want to move on. Remember that $50 billion that Congress added to the summer’s big budget bill to offset the much larger cuts in that bill to rural hospitals? Well, now we know how HHS plans to distribute it, and there are so many strings attached and such a short time frame that Politico is cheekily calling it the rural health “Hunger Games.” Alice, you took a closer look at this. Why are there so many oops here? 

Ollstein: So this was a creation of Congress at the last minute in order to buy votes, essentially. Things were going sideways with the “One Big Beautiful Bill,” and there was a lot of anxiety on both sides of the aisle about the proposed reductions to Medicaid. And this was aimed at alleviating those fears. It’s a new $50 billion fund for rural health.  

It is not specifically for rural hospitals. It has been mischaracterized as such, including by members of the Trump administration who have described it that way. Under the way it is written, it’s possible for none of the money to go directly to rural hospitals, although they are supposed to benefit indirectly. And, really, there’s just going to be such broad discretion — partially in the hands of governors and partially in the hands of Dr. [Mehmet] Oz — about who’s going to get this money. 

And so right now, states have just a few weeks to put together an application for a piece of this pie, and there are some basic structural disadvantages some states will have. So, for one, half of the money is going to be divided up like the Senate, not like the House, which means every state that applies is going to get an equal amount, whether they’re California or whether they’re Idaho. 

Now, as you know, there are a lot more people in California. There are a lot more hospitals. There are a lot more rural hospitals. And so that’s a structural disadvantage these big states have. But on top of that, there are some criteria that CMS created that people feel is more partisan and designed to reward states that align themselves with the Trump administration’s policy priorities. 

So states will get scored higher if they adopt changes that the administration wants to see, like banning people on SNAP [the Supplemental Nutrition Assistance Program] from using it to buy soda and candy and whatever. They just call it non-nutritious food, which, again, who defines that, etc. But also, why are you using a rural health fund to incentivize that change? There are other policy provisions as well. 

And so there’s just a lot of anxiety about who’s going to get this money. And even if all of it does go to the rural hospitals that are struggling so much, according to a report by Manatt, it will not make up for the hit they’re set to take from the rest of the bill, from all of the Medicaid cuts. And even that is a big if, them getting the money. 

Rovner: Yeah, we will also watch this space. All right, well, turning to reproductive health, Alice, we have a really confusing and curious story out of Belgium this week regarding something we talked about months ago, this $10 million worth of contraceptives — pills, shots, implants, and IUDs — that may or may not have been incinerated after the Trump administration decided that providing birth control as part of foreign aid programs is not “lifesaving,” despite the fact that it’s been part of U.S. foreign aid for decades. And while it appears that stockpile has not yet been destroyed, we do know that the administration has refused to sell the supplies to several nonprofits that offered to buy them and distribute them themselves. What is the issue here? 

Ollstein: Yeah, so we don’t know what the actual fate of these contraceptives are, but what’s been really notable is that the administration gave reporters a statement calling them “abortifacient birth control.” Now, none of these contraception devices or medications are abortifacients, but again, this is part of a much bigger blurring of the line between preventing conception and ending a pregnancy. 

You see this in court cases going back to Hobby Lobby and probably before, and continuing to this day in other court cases. You’re seeing it in state policy, in federal policy, just misinformation online. There’s been misinformation about contraception spreading on TikTok, etc. So, to be clear, if you are already pregnant, it will not work. It prevents pregnancy. 

It does not end a pregnancy. And so there’s been a lot of concern about the administration parroting those talking points that you’re hearing from conservative activist groups on that front. 

Rovner: All right. Finally, this week, the on-again, off-again defunding of Planned Parenthood is apparently on again after a federal appeals court overruled a lower court that had blocked the defunding — a triple-quadruple negative. What happens now? 

Ollstein: We don’t know if there is going to be an appeal, so we will have to see there. But for now, the defunding is happening. And even when it was put on pause by lower courts, you started to see clinics close all around the country. In Ohio, in Michigan, in Vermont, in New York, there’ve been Planned Parenthood clinics closing because they were already on the edge and they can’t take the uncertainty of not knowing if the funding is going to be there. And so I think even if, and I think this isn’t likely, even if the money is restored, then it could come too late for a lot of these places. 

Rovner: That seems to be a theme running throughout today’s podcast of things that even if they get reversed, might be too late. All right, well, that is this week’s news. Now we’ll play my interview with Troyen Brennan about primary care, and then we will come back and do our extra credits. 

I am so pleased to welcome Dr. Troyen Brennan to the podcast. If ever there was an all-purpose utility player in health policy, Troyen Brennan would have to be it. He’s worked as a physician, a Harvard researcher and professor, and as an executive in several health care companies, including as chief medical officer for Aetna and CVS Health. But he spent the past two years talking to people about the paradox that is primary health care in the U.S., which he’s chronicled in his brand new book, “Wonderful and Broken: The Complex Reality of Primary Care in the United States.” Troyen Brennan, thank you so much for joining us. 

Troyen Brennan: Thank you very much for having me. 

Rovner: So when I say primary care is a paradox, I really, really mean it. At the same time, we see pretty much universal agreement that primary care is the very foundation of a well-functioning health care system and that good, personalized primary care is something that every patient yearns for. We see more and more primary care practitioners leaving the profession or opting not to join it in the first place when they end their medical training. 

And who can blame them? Primary care providers today are overworked, underpaid, and pulled in dozens of directions at once, leaving many feeling they’re letting themselves and their patients down. How did we get to a point where primary care is, as you say, both wonderful and broken? 

Brennan: Well, I kind of lay it at the structural role of health care financing, a fee-for-service mechanism, which you well understand, I think most of your readers and viewers would understand, is being paid on the piece. And the more you can do a procedure and get an expensive piece of equipment involved or use an operating room, you can earn a good deal of money in our health care system. 

But it’s not a payment structure that’s designed for long-term, continuous relationship with individuals and trying to keep them healthy and promote their health and get them involved in their own decision-making and help them make sense of what is a complicated health care system. So a fee-for-service just doesn’t fit with primary care. And primary care kind of evolved out of general practice at the same time that our health care system really began to change 50 to 60 years ago, and it just has not done well. 

And each year, it’s worse and worse as a result of being stuck in this particular approach to paying for health care services. And we don’t take much active intervention in the health care system. I mean, it is a heavily regulated industry, that’s for sure. But it’s been very difficult for policymakers to come up with new solutions for primary care. 

Rovner: So, for the students in our audience, can you lay out what exactly you mean when you talk about primary care? It’s not just doctors, right? 

Brennan: No, it’s not just doctors. Primary care is any provider. And it’s important to note that more increasingly the people who you’re going to see as your primary care provider could be trained as nurse practitioners or physician associates in addition to being physicians. But I think that there have been experts who’ve laid out what the characteristics of primary care are over the years. 

Barbara Starfield, who was the long-term professor at Johns Hopkins University, a pediatrician, who in many ways did almost all the important initial research in primary care, thought that the important aspects of being in primary care were that you were going to be patient-centered, the patient was going to be an active participant in the care, but it was going to be ongoing and continuous over the lifetime of the patient. So it was a long-term relationship, unlike a lot of the other smaller and shorter-term relationships you would have with specialists — that you were concerned about the patient’s overall health and that you were promoting their health. So that list has been extended by Tom Bodenheimer and others who write about primary care, but I think it’s still pretty much a matter of I’m a member of a provider’s panel. This is who I see when I have a health care problem. I’m going to rely on this person long-term. They’re going to help me make that are going to ensure that my care is both cost-efficient and that I’m going to avoid illnesses when at all possible. 

Rovner: So you write about Primary Care 1.0, Primary Care 2.0, and Primary Care 3.0, which is the goal for a better-functioning system. What are the differences between those things? 

Brennan: Well, Primary Care 1.0 is just what I would say is a standard idea of primary care where you’ve got a relationship with an individual provider and that individual provider is an independent primary care doctor, kind of like the old “Marcus Welby” model. I mean, I may be dating myself by using that term, but I think people still try to refer to the primary care provider of old as Marcus Welby. 

The second, Primary Care 2.0, was really a result of the efforts by the Clinton administration, both President [Bill] Clinton and the first lady, to change health care. And they basically spooked most of health care into thinking we were moving into a managed-care situation. And as a result, at most hospitals, and I was a hospital administrator at this time, we thought we had to get a big base of primary care doctors in order to get the referrals we needed to feed the rest of the operation. 

And so we hired lots of primary care doctors, and that was Primary Care 2.0, primary care doctors in integrated delivery systems working with the integrated delivery system. Primary Care 3.0 is really a move to value-based care, where no longer you’re dependent on a fee-for-service mechanism, that is a doctor billing their evaluation and management codes, but they’re getting paid prospectively to try to keep the patient healthy. And it’s certainly more modern. And, in many ways, I think most people in health care, the health care policy cognizant, think it’s a much better approach to primary care. It fits with this notion of continuity, health promotion, prevention of disease, much more so than a fee-for-service mechanism does. But we’ve had a lot of difficulty getting to significant momentum around value-based care in our health care system. 

Rovner: How do we get more students into primary care in all the professions? I mean, I know we’ve even seen that majorities of physician assistants are going into specialties. Some of these medical schools that were created to turn out primary care physicians are finding that a majority of their graduates are wanting to become specialists. It’s still pretty bleak out there if you’re a primary care practitioner. It’s really hard work. 

Brennan: It is hard work. Really two things, I think. One is you have to pay more. You have to put more money into the system on the primary care side. And there’s a variety of different ways in which you would do that. I would do it through a value-based approach, but some people think you need to do it through a reordering of the fee structure that’s overseen by the RVS Update Committee, the so-called RUC. 

The second thing is I think you have to open more, and there has been movement in this direction, more training programs that are community-based primary care. And there is debate amongst the experts in the physician and nurse practitioner workforce area about exactly what that should look like. Some say there are enough training programs. But at least in my observation, if there were more training program slots available, there would then be more students, because there’d be more development of osteopathic hospitals and more development of hospitals overseas. And the foreign medical graduates and the osteopaths really take up a huge portion of our primary care slots today. 

Rovner: So over the past decade, we’ve seen lots of big companies try to move into the primary care space only, as you point out in the book, to back right back out again. Why is it so hard for these big companies to actually fix what ails primary care? And if they can’t, who can? 

Brennan: Well, I don’t think they have much expertise at it, and I think they go at it in a variety of different relatively ham-handed ways. I mean, I would say Walmart never, at least from the outside — and there’s lots of smart people at Walmart, far smarter than I am, and I’m sure they knew what they were doing — but at least on the outside, they tried a variety of different kinds of things, but you could never tell exactly what their strategy was going to be. 

Walgreens invested in a company, VillageMD, which had expanded in size from something like 12 physicians to 1,200 physicians over a two-year period of time. That’s a big warning signal that maybe something’s going wrong there with that kind of rapid expansion. And what I see is a very good primary care practice and, in some cases, thriving. 

Now, I do raise in the book, and as you well know, there’s big questions about whether or not those kinds of practices, which are oriented towards Medicare Advantage, are going to thrive as we take dollars out of Medicare Advantage by changing the overall coding structure. 

So it’ll be very interesting to see. But I’ve been at it a long time. I know you have, too. And what we see with regard to things like Medicare Advantage is sort of a sinusoidal wave, but overall increasing predominance in the health care system. So I don’t think we’ll set that back. 

Rovner: So everybody seems to be pretty grim about the future of the health care system, but you’re optimistic at least about primary care after doing this project, aren’t you? 

Brennan: Well, you go out and talk to a bunch of people who are taking care of patients, and especially when you’re talking to people at federally qualified health centers who are taking care of very sick, impoverished patients and extraordinarily committed to their welfare, it’s hard not to be optimistic. And I went to places where the physicians were completely burned out. 

But even though they’re burned out, charred in many ways, there’s still a flame of enthusiasm for care of patients. And I found that to be overwhelming in the travels that I did. And so you can’t help but be optimistic about it. But I think from a policy point of view, we could do a far better job of supporting those people than what we’re doing today. 

Rovner: Well, we shall see how things go forward. Dr. Troyen Brennan, thank you so much. 

Brennan: Thank you very much for having me, Julie. I really appreciate it. 

Rovner: OK, we’re back. It’s time for our extra-credit segment. That’s where we each recognize a story we read this week we think you should read, too. Don’t worry if you miss it. We will post the in our show notes on your phone or other mobile device. Joanne, why don’t you go first this week? 

Kenen: Well, actually, this is a story I published in Politico Magazine this morning, “Why Voters Will Feel the Impact of GOP Health Cuts Before the Midterms.” There is this conventional wisdom in Washington and perhaps beyond that — since the Republicans push most of the health provisions, not the ACA subsidies, most of the things in the “One Big Beautiful” Bill law, most of them are after the midterms, November 2026, most of them are starting in Jan.27 and subsequent years — that they protected themselves from political backlash. 

And I basically just made the case that no, they didn’t. We don’t know how people were going to vote. We don’t know who they’re going to blame, but people are beginning — notifications in both the political advocacy and just the bread-and-butter health plans having to tell people what’s changing and who’s at risk and all that. We’re going to be hearing a lot about this. 

State governments are going to have huge holes in their budgets because of the changes to provider taxes that help them finance Medicaid. And those debates are going to start beginning in January. So basically, I just wrote that, no, this is not a 2027 story. This is a right-now story, and the political ramifications are going to start soon. 

Rovner: Yeah. Alice. 

Ollstein: So I have a piece from The New York Times called “I Have Dental Insurance. Why Do I Pay So Much for Care?” And it asks the question, Is the entire concept of dental insurance a scam? And there are some mixed views on whether or not it is a scam, but I think everyone, all the experts they quoted in the piece, agree that it is, in general, way less generous and protective than health insurance. People often have to pay a ton of money out-of-pocket for procedures. They hit their annual limits really quickly. 

One procedure can knock out all of your insurance benefits for the entire year. And if you need another one, better be willing to pay for it yourself. And it is just, in general, not created in a way that incentivizes people taking good care of their teeth. And it just made me think about how long the health of your teeth has been a class marker for just this reason. Basically, only the wealthy can really afford to get everything they need on that front. 

Rovner: And, boy, has dental care gotten expensive. Margot. 

Sanger-Katz: I wanted to highlight a story from ProPublica called “Programs for Students With Hearing and Vision Loss Harmed by Trump’s Anti-Diversity Push.” And these reporters found that the cancellation of a number of Department of Education special education grants has led to really big potential cutbacks in services for this very vulnerable population, relatively small population of children who are both deaf and blind and who obviously need very specialized educational assistance to teach them to read and communicate. 

And I like the story because it was a good reminder that DEI — diversity, equity, and inclusion — inclusion policies are often targeted at people with disabilities. And I think this is a population that is often not thought about and not talked about when that term, that DEI moniker, is thrown around as a turn of phrase. So these are some students who really seem like they’re going to lose out on very much-needed and specialized educational services as a result of these cancellations. 

And in some cases, it appears that their grants were canceled because of word-search-type reasons, where there were just some words, like “privilege,” in their grant application that flagged them for cancellation because they were seen as undesirable. 

Rovner: Presumably unintended consequences. Well, my extra credit this week is from The New York Times Magazine, and it’s called “Trump Is Shutting Down the War on Cancer,” by Jonathan Mahler. And I know we’ve talked about this repeatedly, but here in one place is a really good take on just how the administration is, perhaps unwittingly, undoing decades of biomedical advances, but doing it for really no particularly, at least no stated, reason and what the implications could be going forward. It’s a really good and thorough explanation in one medium-length read. 

All right, that is this week’s show. Thanks as always to our editor, Emmarie Huetteman, and our producer-engineer, Francis Ying. If you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review. That helps other people find us, too. Also, as always, you can email us your comments or questions. We’re at whatthehealth@kff.org, or you can find me at X, @jrovner, or on Bluesky @julierovner. Where are you folks hanging on social media these days? Joanne? 

Kenen: I’m more on Bluesky and LinkedIn

Rovner: Margot? 

Sanger-Katz: You can find me @SangerKatz in all the places and on Signal at SangerKatz.01. 

Rovner: There you go. Alice. 

Ollstein: On Bluesky @alicemiranda and on X @AliceOllstein

Rovner: We’ll be back in your feed next week. Until then, be healthy. 

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Novartis Loses India Patent on Heart Failure Drug Vymada

New Delhi: In a major setback for Swiss drugmaker Novartis, the Indian Patent Office (IPO) has cancelled the patent for its heart failure drug Vymada (sold globally as Entresto), ruling that the invention lacked novelty and inventive merit.

The ruling, issued on September 12, 2025, by Deputy Controller of Patents and Designs D. Usha Rao, found the patent lacking in novelty and inventive step, according to various news reports. The patent in question, No. 414518, covered a “supramolecular complex” of sacubitril and valsartan.

Vymada is a combination medication that contains two active ingredients:

Sacubitril: A neprilysin inhibitor used in combination with valsartan as an adjunct to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.

Valsartan: An angiotensin receptor blocker (ARB) that helps to relax blood vessels, allowing blood to flow more smoothly and the heart to pump more efficiently.

Also Read:Interim relief to Novartis: Delhi HC reinstates Entresto (Sacubitril-Valsartan) patent in India

In its order, the IPO noted that Novartis had failed to establish any therapeutic advantage of the complex over existing formulations. “No experimental data, comparative studies or technical rationale have been provided to substantiate any enhanced efficacy,” the order stated, as quoted by Moneycontrol.

The drug has long been the focus of legal battles, with courts earlier restricting generic launches by Natco, Torrent Pharma, MSN Labs, and Eris Lifesciences following Novartis’ lawsuits. Several firms had already entered the market “at risk,” facing ongoing litigation threats. With the patent now revoked, “companies are free to launch, and more competitors are likely to enter, which will further reduce the cost of treatment,” an industry expert told The Times of India.

Vymada, commonly prescribed for heart failure and hypertension, is one of Novartis’ top-selling drugs, bringing in $7.8 billion globally in 2024. The September 12 ruling by the Deputy Controller of Patents and Designs is viewed as a step that could pave the way for lower-cost generics.

In her order revoking the patent on the “supramolecular complex” of sacubitril and valsartan — the key components of Vymada — D. Usha Rao observed that Novartis had not demonstrated any distinct therapeutic benefit of the claimed complex compared to existing drug formulations, Moneycontrol reported.

The revocation came in response to post-grant challenges filed by the Indian Pharmaceutical Alliance (IPA), a body representing leading domestic manufacturers, with IPCA and Micro Labs also contesting the patent at this stage.

In an order dated September 12, accessed by The Times of India, D. Usha Rao, Deputy Controller of Patents and Designs, observed:

"The patentee has failed to disclose any demonstrated advantages or technical advancement of the claimed supramolecular complex over the combination already disclosed in D1 (closest prior art, patentee's own earlier application). No experimental data, comparative studies or technical rationale have been provided to substantiate any enhanced efficacy. Further no improved therapeutic efficacy has been shown."

The order further stated:

"I have found that the grounds under Section 25(2)(b) - lack of novelty, 25(2)(c) - prior claiming, 25(2)(e) - lack of inventive step, 25(2)(g) complete specification does not sufficiently and clearly describe the invention. Hence the patent no. 414518 is revoked and the said case is disposed of under section 25(2) of The Patents Act, 1970."

Moneycontrol reports that the revocation caps nearly two years of litigation that began in December 2023, when the Indian Pharmaceutical Alliance (IPA) challenged the patent on grounds of lack of novelty, prior claiming, obviousness, and insufficiency of disclosure. After multiple recommendations for cancellation and a Delhi High Court-directed round of rebuttal evidence, the controller held a final hearing on August 20, which Novartis’ representatives did not attend. The order also noted that while Novartis’ earlier sacubitril–valsartan patent had expired in January 2023, the company sought to extend exclusivity by patenting a crystalline form of the drug — a move Indian firms opposed as an attempt at “evergreening.”

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