Mujeres negras sopesan riesgos emergentes de alisadores para el cabello “adictivos”
Deanna Denham Hughes quedó en shock cuando le diagnosticaron cáncer de ovario el año pasado. Solo tenía 32 años. No había antecedentes familiares, y las pruebas no encontraron ningún vínculo genético. Hughes se preguntó por qué ella, una madre negra saludable de dos hijos, desarrollaría una enfermedad conocida como el “asesino silencioso”.
Tras una cirugía de emergencia para extirpar el tumor, junto con sus ovarios, útero, trompas de Falopio y apéndice, Hughes contó que vio una publicación en Instagram en la que una mujer con cáncer uterino relacionaba su condición con alisadores químicos para el cabello.
“Casi me desmayo”, dijo desde su casa en Smyrna, Georgia.
Cuando tenía unos 4 años, su madre comenzó a aplicarle un alisador químico, o “relajante”, en el cabello cada seis u ocho semanas. “Quemaba y olía terrible”, recordó Hughes. “Pero era parte de nuestra rutina para ‘lidiar con mi cabello'”.
La rutina continuó hasta que fue a la universidad y conoció a otras mujeres negras que llevaban el cabello de forma natural. Pronto, Hughes dejó de usar alisadores.
Las presiones sociales y económicas han llevado durante mucho tiempo a las niñas y mujeres negras a alisar su cabello para cumplir con los estándares de belleza eurocéntricos. Pero los alisadores químicos tienen un olor desagradable, son costosos y a veces causan quemaduras dolorosas en el cuero cabelludo. Y ahora hay cada vez más evidencia de que podrían ser un riesgo para la salud.
Los alisadores pueden contener carcinógenos, como agentes liberadores de formaldehído, ftalatos y otros compuestos que alteran el sistema endócrino, según estudios de los Institutos Nacionales de Salud. Estas sustancias químicas pueden imitar las hormonas del cuerpo y se han vinculado con cánceres de seno, útero y ovario, muestran investigaciones.
Investigadores y médicos especializados en cáncer dicen que la aplicación frecuente y de por vida de alisadores químicos en el cabello y el cuero cabelludo de mujeres afroamericanas podría explicar por qué los cánceres relacionados con hormonas afectan de manera desproporcionada a mujeres negras en comparación con mujeres blancas.
“Lo que hay en estos productos es perjudicial”, dijo Tamarra James-Todd, profesora de epidemiología en la Escuela de Salud Pública T.H. Chan de Harvard, quien ha estudiado productos alisadores por los últimos 20 años.
James-Todd cree que los fabricantes, legisladores y médicos deberían advertir a los consumidores que los alisadores podrían causar cáncer y otros problemas de salud. Pero los reguladores han sido lentos en actuar, los médicos se han mostrado reacios a tomar la causa, y el racismo continúa dictando los estándares de moda que dificultan que las mujeres dejen los alisadores, productos tan adictivos que son conocidos como “crema adictiva” (“creamy crack”).
Michelle Obama alisó su cabello cuando Barack era presidente porque creía que los estadounidenses “no estaban preparados” para verla con trenzas, dijo la ex primera dama después de dejar la Casa Blanca. El ejército de los Estados Unidos todavía prohibía estilos populares de cabello negro, como rastas y trenzas, mientras el primer presidente negro del país estaba en el cargo.
En 2019, California se convirtió en el primer estado de casi 20 en prohibir la discriminación basada en el cabello. El año pasado, la Cámara de Representantes de los Estados Unidos aprobó una legislación similar, conocida como la Ley CROWN (Creating a Respectful and Open World of Natural Hair). Sin embargo, el proyecto de ley fracasó en el Senado.
La necesidad de legislación destaca los desafíos que enfrentan las niñas y mujeres negras en la escuela y en el lugar de trabajo.
“Tienes que elegir tus batallas”, dijo Ryland Gore, cirujana oncológica con sede en Atlanta. Gore informa a sus pacientes con cáncer de mama sobre el mayor riesgo de cáncer debido a los alisadores. A pesar de su conocimiento, Gore continúa usando alisadores químicos en su propio cabello, como lo ha hecho desde que tenía unos 7 años.
“Tu cabello cuenta una historia”, dijo.
En las conversaciones con sus pacientes, Gore a veces también habla sobre cómo las mujeres afroamericanas solían tejer mensajes en sus trenzas sobre la ruta a seguir en el Underground Railroad mientras buscaban la libertad de la esclavitud.
“Es simplemente una discusión profunda”, que abarca cultura, historia e investigación sobre las prácticas de estilo de peinados actuales, dijo. “Los datos están ahí fuera. Por lo tanto, se les debe advertir a los pacientes, y luego pueden tomar una decisión”.
La primera pista de una conexión entre los productos para el cabello y problemas de salud surgió en la década de 1990. Los médicos comenzaron a ver signos de madurez sexual en bebés y niñas negras que desarrollaban senos y vello púbico después de usar champús que contenían estrógeno o extracto placentario. Cuando las niñas dejaban de usar el champú, el desarrollo del cabello y los senos retrocedían.
Desde entonces, James-Todd y otros investigadores han vinculado compuestos químicos en productos para el cabello con una variedad de problemas de salud más prevalentes entre las mujeres negras, desde la pubertad temprana hasta el parto prematuro, la obesidad y la diabetes.
En los últimos años, los investigadores se han enfocado en una posible conexión entre los alisadores químicos y los cánceres relacionados con hormonas, como el que desarrolló Hughes, que tienden a ser más agresivos y mortales en las mujeres negras.
Un estudio de 2017 encontró que las mujeres blancas que usaban alisadores químicos tenían casi el doble de probabilidades de desarrollar cáncer de seno que aquellas que no los usaban. Debido a que la gran mayoría de las participantes negras del estudio usaban alisadores, los investigadores no pudieron probar efectivamente la asociación en mujeres negras, según afirmó la autora principal, Adana Llanos, profesora asociada de epidemiología en la Escuela de Salud Pública Mailman de la Universidad de Columbia.
Los investigadores lo probaron en 2020.
El llamado Sister Study (Estudio de las Hermanas), una importante investigación del Instituto Nacional de Ciencias de la Salud Ambiental sobre las causas del cáncer de mama y enfermedades relacionadas, hizo el seguimiento de 50,000 mujeres estadounidenses cuyas hermanas habían sido diagnosticadas con cáncer de mama y que estaban libres de cáncer cuando se inscribieron. Independientemente de la raza, las mujeres que informaron haber usado alisadores en el año anterior tenían un 18% más de probabilidades de ser diagnosticadas con cáncer de mama. Aquellas que usaron alisadores al menos cada cinco a ocho semanas tenían un 31% más de riesgo de ese cáncer.
Casi el 75% de las hermanas negras usaron alisadores en el año anterior, en comparación con solo el 3% de las hermanas blancas no hispanas. Tres cuartas partes de las mujeres negras también informaron haber usado alisadores cuando eran adolescentes, y el uso frecuente de alisadores químicos durante la adolescencia aumentó el riesgo de cáncer de mama premenopáusico.
En 2021, un análisis de los datos del Sister Study mostró que las hermanas que usaban frecuentemente alisadores o productos para el alisado tenían el doble de riesgo de cáncer de ovario. Otro análisis, en 2022, encontró que el uso frecuente aumentaba en más del doble el riesgo de cáncer de útero.
Después de que los investigadores descubrieron la relación con el cáncer de útero, algunos pidieron cambios en las políticas y otras medidas para reducir la exposición a los alisadores.
“Es hora de intervenir”, escribió Llanos y sus colegas en un editorial que acompañó el análisis del cáncer de útero. Aunque reconocen la necesidad de más investigaciones, lanzaron un “llamado a la acción”.
Nadie puede afirmar que el uso de alisadores permanentes causará cáncer, dijo Llanos en una entrevista. “Así no funciona el cáncer”, dijo, señalando que algunos fumadores nunca desarrollan cáncer de pulmón, a pesar de que el tabaquismo es un factor de riesgo conocido.
El corpus de investigación sobre los alisadores para el cabello y el cáncer es más limitado, dijo Llanos, quien dejó de usar alisadores químicos hace 15 años. Pero preguntó retóricamente: “¿Necesitamos investigar durante otros 50 años para saber que los alisadores químicos son perjudiciales?”.
Charlotte Gamble, ginecóloga oncológica cuya práctica en Washington, D.C., incluye a mujeres negras con cáncer de útero y ovario, dijo que ella y sus colegas ven los hallazgos del estudio sobre el cáncer de útero como dignos de una exploración más profunda, pero aún no deberían discutirse con los pacientes.
“Aún tengo mis dudas”, dijo. “Se necesita mucha más información”.
Mientras tanto, James-Todd y otros investigadores creen que han construido un sólido corpus de evidencia.
“Hay suficientes cosas que sí sabemos como para comenzar a tomar medidas, desarrollar intervenciones, proporcionar información útil a los médicos, pacientes y al público en general”, dijo Traci Bethea, profesora asistente en la Oficina de Salud de las Minorías e Investigación sobre Disparidades en Salud de la Universidad de Georgetown.
La responsabilidad de regular los productos de cuidado personal, incluidos los alisadores químicos para el cabello y las tinturas, que también se han vinculado con cánceres relacionados con hormonas, recae en la Administración de Alimentos y Medicamentos (FDA).
Sin embargo, la FDA no somete los productos de cuidado personal al mismo proceso de aprobación que utiliza para alimentos y medicamentos. La FDA solo restringe 11 categorías de productos químicos utilizados en cosméticos, mientras que las preocupaciones sobre los efectos en la salud han llevado a la Unión Europea a restringir al menos 2,400 sustancias.
En marzo, las representantes Ayanna Pressley (demócrata de Massachusetts) y Shontel Brown (demócrata de Ohio) pidieron a la FDA que investigara la posible amenaza para la salud que representan los alisadores químicos. Un representante de la FDA dijo que la agencia lo investigaría.
Los peinados naturales están resurgiendo entre las niñas y mujeres negras, pero muchas siguen dependiendo de la “crema adictiva”, según Dede Teteh, profesora asistente de salud pública en la Universidad Chapman.
Teteh tuvo su primer alisado permanente a los 8 años y ha luchado por dejar los alisadores de adulta. Ahora usa trenzas estilo “locs”. Hace poco, consideró alisarse químicamente el cabello para una entrevista de trabajo académica porque no quería que su cabello “fuera un obstáculo” cuando se presentara ante profesores blancos.
Teteh lideró un proyecto de investigación sobre la salud del cabello llamado “The Cost of Beauty” (El Costo de la Belleza) publicado en 2017. Ella y su equipo entrevistaron a 91 mujeres negras en el sur de California. Algunas reaccionaron de manera “combativa” ante la idea de dejar los alisadores y afirmaron que “todo puede causar cáncer”.
Sus reacciones reflejan los desafíos que enfrentan las mujeres negras en Estados Unidos, dijo Teteh.
“No es que la gente no quiera escuchar información relacionada con su salud”, dijo. “Pero quieren que la información se comparta de manera empática con la difícil situación de ser negra aquí en los Estados Unidos”.
Kara Nelson de KFF Health News colaboró con este informe.
Este artículo fue producido por KFF Health News, que publica California Healthline, un servicio editorialmente independiente de la California Health Care Foundation.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
USE OUR CONTENT
This story can be republished for free (details).
1 year 10 months ago
Noticias En Español, Race and Health, States, Cancer, FDA, Georgia
KFF Health News' 'What the Health?': The Long Road to Reining In Short-Term Plans
The Host
Julie Rovner
KFF Health News
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.
It took more than two years, but the Biden administration has finally kept a promise made by then-candidate Joe Biden to roll back the Trump administration’s expansion of short-term, limited-duration health plans. The plans have been controversial because, while they offer lower premiums than more comprehensive health plans, they offer far fewer benefits and are not subject to the consumer protections of the Affordable Care Act.
Also this week, the FDA for the first time approved the over-the-counter sale of a hormonal birth control pill. With more states imposing restrictions on abortion, backers of the move say making it easier to prevent pregnancy is necessary now more than ever.
This week’s panelists are Julie Rovner of KFF Health News, Alice Miranda Ollstein of Politico, Amy Goldstein of The Washington Post, and Rachel Cohrs of Stat.
Panelists
Alice Miranda Ollstein
Politico
Amy Goldstein
The Washington Post
Rachel Cohrs
Stat News
Among the takeaways from this week’s episode:
- The FDA’s much-anticipated approval of the first over-the-counter hormonal birth control pill followed the advice of its outside advisory committee. The pill, Opill, will be available on shelves without age restrictions.
- The Biden administration announced moves to limit so-called junk plans on insurance marketplaces. The Trump administration had dropped many restrictions on the plans, which were originally intended to be used for short-term coverage gaps.
- As the nation continues to settle into a post-Dobbs patchwork of abortion laws, the Iowa Legislature approved a six-week ban on the procedure. And an Idaho law offers a key test of cross-border policing of abortion seekers, as other states watch how it unfolds.
- In other news, Georgia’s Medicaid work requirements took effect July 1, implementing new restrictions on who is eligible for the state-federal program for people with low incomes or disabilities. And the Supreme Court’s decision on affirmative action has the potential to shape the health care workforce, which research shows could have implications for the quality of patient care and health outcomes.
Also this week, Rovner interviews KFF Health News’ Bram Sable-Smith, who reported and wrote the latest KFF Health News-NPR “Bill of the Month” feature, about a patient who lacked a permanent mailing address and never got the hospital bills from an emergency surgery — but did receive a summons after she was sued for the debt. If you have an outrageous or exorbitant medical bill you want to share with us, you can do that here.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: KFF Health News’ “Doctor Lands in the Doghouse After Giving Covid Vaccine Waivers Too Freely,” by Brett Kelman.
Rachel Cohrs: ProPublica’s “How Often Do Health Insurers Say No to Patients? No One Knows,” by Robin Fields, and Stat’s “How UnitedHealth’s Acquisition of a Popular Medicare Advantage Algorithm Sparked Internal Dissent Over Denied Care,” by Casey Ross and Bob Herman.
Amy Goldstein: The New York Times’ “Medicare Advantage Plans Offer Few Psychiatrists,” by Reed Abelson.
Alice Miranda Ollstein: The Wall Street Journal’s “America Is Wrapped in Miles of Toxic Lead Cables,” by Susan Pulliam, Shalini Ramachandran, John West, Coulter Jones, and Thomas Gryta.
Also mentioned in this week’s episode:
- Stat’s “How One Medical School Became Remarkably Diverse — Without Considering Race in Admissions,” by Usha Lee McFarling.
- The New York Times’ “With End of Affirmative Action, a Push for a New Tool: Adversity Scores, by Stephanie Saul.
click to open the transcript
Transcript: The Long Road to Reining In Short-Term Plans
KFF Health News’ ‘What the Health?’Episode Title: The Long Road to Reining In Short-Term PlansEpisode Number: 305Published: July 13, 2023
[Editor’s note: This transcript, generated using transcription software, has been edited for style and clarity.]
Julie Rovner: Hello and welcome back to “What the Health?” I’m 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, July 13, at 10 a.m. As always, news happens fast and things might have 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: Good morning.
Rovner: Rachel Cohrs of Stat News.
Rachel Cohrs: Hi, everybody.
Rovner: And Amy Goldstein of The Washington Post.
Goldstein: Good to be with you.
Rovner: Later in this episode, we’ll have my interview with KFF Health News’ Bram Sable-Smith, who wrote the latest KFF Health News-NPR “Bill of the Month.” The hospital that provided care to this month’s patient couldn’t find her to send her a bill, but the debt collectors sure could. But first, this week’s news. Actually, it’s more like the last month’s news because we actually haven’t talked about news in a while. So we’re going to try to hit a bunch of items in sort of a lightning round. Let’s start with something we knew was coming. We just didn’t know exactly when. Last week, the Biden administration finally cracked down on short-term health plans. Those are the ones that are not subject to the strict rules of the Affordable Care Act. Amy, you wrote about this. What are short-term plans, and why have they been so controversial?
Goldstein: Well, short-term plans — they’re called short-term limited-duration plans, and really terrible argot, but that’s their name. They’ve been around as an alternative to plans that are meeting the rules of the Affordable Care Act. They were originally designed for people to use as small bridges between, say, when they lost a job and they were about to get a new job and they needed something in the interim to provide health coverage. Republicans, during the time that they were trying very hard several years ago to get rid of as much as the Affordable Care Act as they could — they didn’t succeed at a lot of that, but they did succeed during the Trump administration at lengthening the time that people could have these plans. So they extended them from what had been a three-month maximum during the latter part of the [Barack] Obama administration to 12 months, and then they were renewable for up to three years. And Democrats began calling these “junk plans,” saying that people didn’t exactly know what they were buying, that the premiums were low but the benefits were small and if people got sick and really needed a lot of care they could be stuck paying for a lot of it on their own.
Rovner: And these were the very plans that the ACA was kind of designed to get rid of, right, where people would say, I have this great health plan, it only costs me $50 a month — but by the way, it only provides $500 worth of care.
Goldstein: Well, there’s that. And the other thing that the ACA was designed to do is treat people with preexisting conditions equally. And these plans do not have to do that. Some do, but they’re not required to. So President [Joe] Biden, since he was candidate Biden running for the 2020 election, has been saying for quite a while that he was going to knock down the duration of these plans, and some of his fellow Democrats have been leaning on him: “Why haven’t you done it yet?” And last week, he finally did. He didn’t bring it exactly to where the Obama administration had it, but he brought them down to three months with a one-month extension, so a total of four months.
Rovner: And I guess the resistance here is that they’re still kind of popular, right, for people who think they would rather pay very low premiums for very few benefits?
Goldstein: Well, the catch is that we don’t really know how popular they are because there aren’t very reliable data on how many people have these. But the presumption is that some people like them.
Rovner: All right, well we will see what happens with this time they’re trying to crack down. Let us move on to abortion and reproductive rights. We will start with the breaking news. The Food and Drug Administration just this morning approved Opill, which is the first over-the-counter birth control pill. Alice, we’ve known this was coming, right?
Ollstein: Yes, we did. We thought it would be a little later in the summer. But the decision itself reflects what the FDA’s outside advisory panel strongly recommended, which is to make these pills available over the counter without a prescription and without an age restriction, which was one looming question over this process.
Rovner: Yeah, I guess, Rachel, I mean, the issue here has been can women be trusted enough to know when they shouldn’t take birth control pills because they are contraindicated for some people?
Rachel Cohrs: Right. And I think that certainly it’s important to read through the information. There’s a question as to whether women will do that. And one part of the release that stood out to me is that the specific type of pill that this is requires women to take it around the same time every day, which is not necessarily the case for all birth control pills. And I think there’s a little bit more flexibility than there used to be with this kind of pill. But it is just important that all of this communication happens. And if there’s not a doctor or pharmacist in the middle, I think it will be kind of interesting to see how this plays out in the real world.
Rovner: Well, while this could definitely help people prevent pregnancy who don’t want to get pregnant, there’s certainly a lot of action still in the states around abortion. We’re going to start in Iowa, which since the last time we spoke has done basically a 360 on abortion. Last month, the state Supreme Court deadlocked on whether to reinstate a 2018 ban on almost all abortions. That left a lower court order blocking the ban intact, so abortion remained legal in Iowa. But anti-abortion Gov. Kim Reynolds refused to take no for an answer. She called a special session of the state legislature, which on Tuesday essentially repassed the 2018 ban. It’s supposed to take effect as soon as the governor signs it, which could be as soon as Friday. But first it goes back to court, right, Alice?
Ollstein: Right. As with all of these things, there’s just a lot of back-and-forth before it’s final. Groups have already filed a lawsuit. And, you know, because the courts’ sort of mixed treatment of the previous version of this, we sort of don’t know what’s going to happen. But the law could go into effect and then be blocked by courts later or it could be blocked before it goes into effect. There’s a lot of different ways this could go, but this is one of several states where new restrictions are coming online. We’re more than a year out from the Dobbs decision now, and things are not settled at all. Things are still flipping back and forth in different states.
Rovner: Yeah, there’s a lot of states where old restrictions came into effect and then were blocked and now they’re putting new restrictions and they might be blocked. Well, turning to another “I” state, this time Idaho, where the legislature this spring passed a first-in-the-nation bill attempting to criminalize the act of helping a minor cross state lines for an abortion, even if the abortion is legal in the state the minor travels to. Now, abortion rights supporters have filed a first-in-the-nation lawsuit to block the first-in-the-nation law. This could have really big ramifications. This is different from a lot of what’s going on in a lot of the other states, right?
Ollstein: Yeah. Over the last year, there’s been a lot of fear on the left of states reaching across their borders to try to police abortion. And it hasn’t really happened yet that we have seen. And so this, I think, is a key test of whether more states will attempt to go in this direction. You know, a lot of blue states passed sort of shield laws for patients, for providers, for data, out of fear that more red states would attempt more cross-border policing. But that really hasn’t materialized broadly yet.
Rovner: I remember Missouri was the one that was talking about it, right, to make it a crime if —
Ollstein: Right.
Rovner: I know they didn’t do it, but they were talking about if women went particularly to Illinois, which is now one of these abortion havens, and came back, they would try to prosecute them, although that never really came to be.
Ollstein: Exactly. And so it’s interesting that even really conservative states with big Republican majorities, most have not gone down this road yet. And so I imagine a lot of them are watching how this case goes.
Rovner: Well, as long as we’re talking about states that start with “I,” let’s turn to Indiana, where Planned Parenthood reports that all of their appointments for abortions are taken between now and when that state’s near-total ban takes effect in a few weeks. This points out something I think often gets missed in these sort of score card maps of states that have bans and restrictions, which is there’s a lot of states where abortion is technically still legal but realistically not available, right?
Ollstein: The difference between being technically legal and available is nothing new. This was true prior to Dobbs as well. There were lots of states that only had one abortion clinic for the entire state. There were, like, six of those. And so, you know, you may have the right to have the procedure on paper, but if there’s only one place you could go and you’re not able to physically get there or they don’t have an appointment within the time window you need, you’re out of luck; that right isn’t, you know, meaningful for you. And so that’s becoming, you know, more true as abortion access is eliminated in a lot of the country and more and more people are depending on fewer and fewer states.
Rovner: And fewer and fewer clinics in fewer and fewer states. Well, finally, an update on the one-man nomination blockade by Alabama Republican Sen. Tommy Tuberville, who we talked about in March. He has stopped approval of basically all Defense Department personnel moves, including routine promotions, in protest of the Biden administration’s policy of providing leave and travel expenses for servicewomen to get abortions if they’re stationed in states where it’s illegal. Now, for the first time in more than 150 years, the Marine Corps has no approved commandant. Any idea which side’s going to back down here? Rachel, this is backing up the entire legislative calendar in the Senate, right?
Cohrs: It is. And I think some of the coverage this week has highlighted just how there hasn’t really been a willingness among Republican leadership to really put the pressure on Tuberville. But honestly, I don’t know when this stops for him. Having temporary leadership in all these positions isn’t kind of the impetus for him to say that he’s made his point. And I think there are also questions about — there may be more education required about exactly what the difference is between a temporary leader and a permanently installed leader. Obviously, the decisions that they’re making every day are life-and-death and are different than the leadership positions we see over at something like the NIH [National Institutes of Health], where, you know, I think it is —
Rovner: Which is also held up. But that’s another story.
Cohrs: Right, another story. But I just don’t see where this ends quite yet, unless there’s some will from Republican leadership to really bring him in line. And they just haven’t summoned that yet.
Rovner: I imagine there’ll be a vote on this when they get to the defense bill, right, which —the defense authorization, which is going to come up, I think, in both houses in the coming weeks. I mean, one would think that if there’s a vote and he loses, he might back down. I’m just guessing here. I guess we’ll have to wait and see what happens with that. All right. Well, it’s also been a busy couple of weeks in other social policy. On the one hand, a new federal law took effect that makes it easier for people to get accommodations to be able to do their jobs while pregnant. And Maine is going to start offering paid family and parental leave, although not until 2026. That makes it the 13th state to enact such a policy. On the other hand, Georgia is the first state to implement work requirements for Medicaid. Amy, the last time we discussed this, federal judges had tossed out Medicaid work requirements and Republicans in Congress were unsuccessful in getting those requirements back into the debt ceiling compromise. So how come Georgia gets to do this?
Goldstein: Well, I’ve begun to think of Medicaid work requirements as whack-a-mole, if you remember the arcade game in which you knock down an animal with a mallet only to have it pop up unexpectedly somewhere else. So, as you say, work requirements was something that Republicans were very eager to institute in 2017, 2018, when the Trump administration’s Center for Medicare & Medicaid Services encouraged states to adopt them. And there were basically plans to give people Medicaid at the time, mainly people in Medicaid expansion groups, if they worked or went to school or did community service for at least 80 hours a month. As you say, that was knocked down both by a district court and then a federal circuit court. And it looked like that was that, particularly when the Biden administration came along and undid the Trump administration’s regulation that had allowed states to submit proposals, the waivers for these kinds of plans. Well, lo and behold, Georgia said they wanted to do this. They said they wanted to do it in a little bit different way, because, for the first time ever, Georgia was going to be a partial expansion state for Medicaid, allowing people to get onto Medicaid if they had incomes up to the poverty level but not up to the full expansion poverty level that the ACA allows. And the Biden administration didn’t like that so much. And that partial expansion was to be twinned with work requirements. The Biden administration didn’t —
Rovner: For that expansion group, though, right? Not for everybody.
Goldstein: Just for that partial expansion group. The Biden administration didn’t like that so much. But last summer, a judge in Georgia said, no, she thinks this is OK. And the reason was that, unlike the other states, if this was pegged to a partial expansion, any expansion with work requirements would increase the number of people with Medicaid. So that was sort of in her judge judgment — I shouldn’t say the judge’s judgment — consistent with the purposes of the program. So Georgia has gone ahead, and the beginning of this month they allowed people to start enrolling in something called Georgia Pathways to Coverage. And we’ll have to see how it goes.
Rovner: Yeah. And just to be clear, I mean, Alice, you did some stellar work back a couple of years ago about Arkansas, about people losing coverage because of the work requirements, even if they were working, just because of how hard it was to report the work hours, right?
Ollstein: Absolutely. I mean, it’s kind of what we’re seeing now with the Medicaid unwinding, is that, you know, people just aren’t able to know what’s going on, aren’t able to be reached, fall through the cracks, can’t navigate the bureaucracy, and lose coverage that they should be entitled to. So we saw that happen, and I think to Amy’s point, the administration seems to be taking a very different stance on states like Arkansas, you know, which already had expanded Medicaid and then went to impose a work requirement, whereas Georgia didn’t have it before and this is kind of a compromise because it’s like, well, more people will be insured if we allow this to go forward total, you know, so maybe it’s better than nothing, although a lot of folks on the left are very opposed to the concept of work requirements, citing data that the people who are on Medicaid who can work are already working — the vast, vast, vast majority. And those who are not working, either they are caring for a child or someone with disability, or they themselves have a disability, or they’re a student. You know, there’s all these categories of why folks are unable to work.
Rovner: But in this expansion group, one would assume that if they’re earning up to the federal poverty line, they have some source of income. So one would assume that many of them are working. But I think it’ll be really interesting for researchers to watch to see, you know, a sort of a proof of concept in either direction with this.
Goldstein: And let me quickly mention a couple of things. Georgia’s rules are actually in some ways the same as what other states had tried to do previously. But in other ways, this is the strictest set of work requirements that anyone has tried in a couple of ways: People have to meet these work requirements up to age 64, which is older than other states had done for the most part. There’s also no exemption if you’re taking care of a child or taking care of an older family member. So how well people, in addition to the bureaucratic hoops that Alice was talking about, which are of grave concern to some of the people who oppose this in Georgia — there’s also a question of who’s going to actually be able to qualify for this.
Rovner: While we are on the subject of court decisions, one of the odd court decisions that I think has happened over the past few weeks is a federal district court decision out of Louisiana barring many officials in the Biden administration, including the surgeon general and the head of the CDC [Centers for Disease Control and Prevention], from talking to social media sites, particularly about things like medical misinformation. This feels like something I had not seen before in terms of actually trying to ban the administration from talking to private companies based on First Amendment concerns, which is what this is.
Cohrs: Right. Well, I mean, the First Amendment protects speech from interference from the government —
Rovner: Right
Cohrs: — which has always been, you know, this gray area with these independent platforms. And I think this issue, you know, has obviously become highly politicized. It came up several times when Rochelle Walensky, the former CDC director, was testifying on the Hill. So I think certainly we’ve seen this trend overall in these highly political court decisions and this strategy that certain litigants are taking where they’re trying to find defendants in a certain jurisdiction that’s going to be advantageous to them. So it will certainly be interesting to see how this plays out in the future and makes its way through the court system, but certainly is an eye-popping precedent. Like you mentioned, we don’t usually see something like this.
Rovner: And I wanted to mention, I think also because this is yet another of these judges that the right has found that are likely to agree with them. Like we’ve seen now: The judges in Texas, we now have one in Louisiana. Sort of kind of watch that docket. While we are still on the subject of courts, 2023 was the first year in the last decade or so that there was not a major health-related decision in the last big cases decided by the Supreme Court. But it seems like one of those non-health cases, the one essentially striking down affirmative action, might have some major implications for health care after all, particularly for medical education, right?
Cohrs: Yes. Some of my colleagues did some I think great follow-up reporting on this. And I think the idea is that there has been research that has shown that when patients are able to see a doctor of their same racial background, that it does have positive implications for their care. And there has also been studies of schools where there have been bans on race-conscious admissions showing that there is a decrease in medical school students from underrepresented backgrounds traditionally. And so I think that cause and effect is concerning for people, that if there are fewer medical students — there already aren’t a representative amount — from underrepresented groups, that could trickle down to, again, just exacerbating so many of these inequities that we see in health care provision. I know there was just a big study on the maternal mortality outcomes that came out recently as well. And I think all of these things are tied together. And I think Axios reported on one interesting potential loophole, was using proxy measures, like where someone went to school or their parents’ background, something like that, to try to ensure diversity from that lens. But I think it certainly is going to make these medical schools recalculate how they’re doing admissions and make some hard choices about how to maintain diversity that can be beneficial for patients.
Rovner: One thing that I think has come up in all of these discussions is the fact that the University of California-Davis has done an interesting job of creating a very diverse medical school class, even though race-conscious admissions have been banned in California for years. So I think a lot of schools are going to be looking sort of to see what UC Davis has done and perhaps emulate that. And I will put one of the UC Davis stories in the show notes for everybody. All right. Finally in this week’s news, the drug industry has filed a lawsuit challenging the Medicare drug price negotiation program that’s just now starting to get off the ground. Rachel, you wrote about this. How does pharma think it can block price-setting for Medicare that Medicare does for pretty much everything else that Medicare pays for? They set prices for hospitals and doctors and medical equipment. Why are drugmakers thinking that they’re special?
Cohrs: Right. So, again, this is four lawsuits as well, not just one: two from two trade groups and two drugmakers. And they’re each kind of using different arguments. But I think the big picture here is if the government called it price-setting, I don’t think pharma would have as much of an argument, but they’re calling it a negotiation. And I think one of the drugmakers’ key claims is that by signing these contracts to enter into this process, they’re tacitly admitting that this price that they come up with in this process is, quote-unquote, “fair.” And, you know, they don’t want to agree to that because then it makes the price that they’re charging everyone else look unfair on the other side of the coin. And I think there’s also these really high penalties for these companies who decide not to participate; I mean, tens of millions of dollars on the first day is the kind of number that we’re seeing for some of these companies that have filed lawsuits. And I think there’s also the option for them to take all of their drugs off of the market. But I think there’s a question with the timeline of whether they could have even done that before the law was passed. So the big picture from the drugmaker side of things is that the penalties are so high for them not to participate and that the government is framing this as a negotiation when it really is just price-setting, like Medicare does in so many other areas. So I think one interesting development that happened this week was that the [U.S.] Chamber of Commerce filed a motion for a preliminary injunction, which could make all of these lawsuits move much faster and really put a stop to the program. We hadn’t seen either of these lawsuits request a motion like that. And I think they requested a ruling by Oct. 1, which is when the first kind of round of 10 drugmakers would have had to sign their contracts with Medicare. So I think this certainly is picking up speed and urgency as we’re moving toward that Sept. 1 selection date.
Rovner: I didn’t even notice. Are these lawsuits all filed here in Washington, D.C., or —
Cohrs: No, they are not. As we’ve seen, the drugmakers are very strategic in where they filed. I think Merck did file in D.C., but the chamber filed in Ohio; it had some of their local chapters join in as well. I think we saw another company file in New Jersey. So I think they are kind of hedging their bets and trying to get rulings from as many different jurisdictions as they can.
Rovner: Find a judge who’s willing to slap an injunction on this whole thing.
Cohrs: Yes.
Rovner: Which we will talk about when and if it happens. All right. That is this week’s news, or at least as much as we have time to get to. Now, we will play my “Bill of the Month” interview with Bram Sable-Smith, and then we will be back with our extra credits. We are pleased to welcome back to the podcast Bram Sable-Smith, who reported and wrote the latest KFF Health News-NPR “Bill of the Month.” Bram, so nice to see you again.
Bram Sable-Smith: Always a pleasure to be here.
Rovner: So, this month’s patient was, like a lot of young people, an uninsured 23-year-old when she ended up in the emergency room. Tell us who she is and what kind of medical care she needed and got.
Sable-Smith: Yeah, that’s right. Her name was Bethany Birch. And, in addition to being uninsured, she was also unemployed at the time, and she had had pain in her diaphragm for eight months. It prevented her from eating. She lost about 25 pounds in that time. And when she went to the emergency room, she found out she needed her gallbladder removed.
Rovner: And got it, right?
Sable-Smith: And got it. Yeah, she got that surgery almost immediately. Because she hadn’t been eating food — her food resistance — it meant she could get in for surgery right away.
Rovner: And that cured her? Yes?
Sable-Smith: It did cure her. Yes, she felt a lot better.
Rovner: So now we’re talking about the bill. The hospital tried to send her the bill, but apparently it couldn’t find her. Is this a common thing, and why couldn’t they find her? One presumes she gave them an address when she presented at the emergency room.
Sable-Smith: She did give them an address, but by the time she was discharged, she had lost her housing. Her home situation was unstable. So just that brief visit to the hospital, by the time she left, she had no more house to live in. And she did end up crashing with her family for several months. And, eventually, she did update her address with the post office. But by the time she had done that, it was after the hospital had sent the three bills to her for her visit.
Rovner: So the hospital doesn’t get any response, and they do what we know hospitals do. They sued for nonpayment. And the debt collection firm did manage to find her. So then what happened?
Sable-Smith: Well, she went to court, and like so many people who end up in court with medical debt, she did not have a lawyer representing her. She met with a representative from the debt collection firm, and she worked out a payment plan to pay her bill, plus court costs, in $100 monthly installments. But at the time, Tennessee had a default interest rate on judgments like the one that Bethany had of 7%. So the judge tacked on a 7% interest rate to her bill.
Rovner: So, yeah, and that was presumably a lot for her to carry. What finally happened with the bill?
Sable-Smith: Well, she paid her $100 monthly payments for over four years. It totaled about $5,200 she paid in that time. But at the same time, the interest rate was accruing. And so she owed an additional $2,700 on top of the initial bill that she had gotten. From her perspective, it was just impossible. She wasn’t digging out of this debt. So she started getting help from a family friend, who’s a billing expert, who took on her case. They asked the hospital and the debt collection firm to settle her debt because she had already paid so much. But they were unsuccessful in doing so. They sent their bill to us. We started reporting the story. Then they asked again to settle her debt by paying an additional $100 on top of what she had already paid. And this time they agreed. And so she settled her debt and she got a balance-zero statement.
Rovner: Amazing how just one phone call from us can do some work. Now, as somebody who is unemployed and, as you pointed out, uninsured at the time she got the care, Bethany should have been eligible for the hospital’s financial assistance policy. Why didn’t she get help before the debt ballooned with court costs and all that interest?
Sable-Smith: Well, the simple answer is that she never applied. But, as we know, it’s much more complicated than that. So given her status as single, uninsured, unemployed, it’s very possible that she would have qualified for financial help, maybe even for free care altogether. But the onus was on her as a patient to apply. And we know her situation was unstable. You know, she went through a period of homelessness. She didn’t have a lot of expendable money at the time. It’s a long process to apply for these programs. There’s a lot of forms. It can be cumbersome. And that prevents a lot of people from applying to these programs. So advocates push for something called presumptive eligibility, where the hospital takes the onus of applying away from patients and they automatically put them through the process. And this hospital that Bethany went to, they actually have switched to that presumptive eligibility model, just not in time to help her case.
Rovner: So what’s the takeaway here? I guess everybody has to be a proactive patient, not just with your medical care, but especially with your bills. What happens to a patient who finds themselves in a similar situation?
Sable-Smith: Well, you know, from a consumer standpoint like that, one takeaway is to ask for financial help. A lot more people qualify than you might think. You might not think you qualify, but it’s very possible you could. And then from a policy perspective, hospitals switching to presumptive eligibility — that’s something that they’re able to do. And also, some states have pushed to ban or even limit interest payments on this kind of medical debt. So that’s something that other people are considering as well.
Rovner: Or you can write to us, and we will show you how in our show notes.
Sable-Smith: That’s always a possibility, too.
Rovner: Bram Sable-Smith, thank you so much.
Sable-Smith: Yeah, thanks for having me.
Rovner: OK, we’re back, and it’s time for our extra credit segment. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Rachel, why don’t you go first?
Cohrs: OK, I’m cheating a little bit and I’m doing a double feature. So the first story for my extra credit is headlined “How Often Do Health Insurers Say No to Patients? No One Knows.” It’s in ProPublica by Robin Fields, and I think it’s just a great feature on the idea that Obamacare entitled the government and patients to more information about how often insurers deny care to patients. And the government hasn’t really pursued that information. And even, like, state health insurance commissions aren’t providing the information they’re collecting. And Robin just had such a difficult time getting any sort of information from anyone, even though we’re legally entitled to it. So I thought that was just kind of a great highlight of this next area of criticism of the health insurance industry, which, and I think that —
Rovner: I would say, all this focus on premiums and not as much focus on what you actually get for those premiums.
Cohrs: Exactly. So true. I think there’ve been some high-profile examples, great reporting. And I thought that meshed well with some reporting from my colleagues Casey Ross and Bob Herman, who wrote a follow-up to some of their prior reporting titled “How UnitedHealth’s Acquisition of a Popular Medicare Advantage Algorithm Sparked Internal Dissent Over Denied Care.” Again, looking at how algorithms in this one privatized Medicare program, which is growing in size and enrollment across the country, was actually overruling clinicians’ decisions about how long patients should be receiving care in facilities. And if the algorithm says they should be done, then they’re done. And I think it definitely sparked some concerns from people in the company who were willing to speak to them just because they were so concerned about this trend.
Rovner: Alice.
Ollstein: I have a very impressive investigation from The Wall Street Journal. There are five bylines, and we will post the link. This is about lead-covered telecom cables owned by AT&T, Verizon, other companies that have been left to decay and leach into the environment all around the country. This documents how the companies knew about them but have not moved to clean them up and get rid of them. They are impacting water sources. They are near playgrounds where children are, and it goes into the very disturbing health impacts of lead exposure. This is something the country has made a lot of progress on when it comes to paint and other sources, but obviously we still have a long way to go.
Rovner: Yeah, because there’s not enough things to be worried about environmentally, here is something else. It is very good reporting.
Rovner: Amy.
Goldstein: My extra credit this week is from The New York Times, by Reed Abelson, with the headline “Medicare Advantage Plans Offer Few Psychiatrists.” And this isn’t a giant story, but I think it is at the nexus of two very important questions: one, the long-standing question of whether privatized Medicare is better or worse for people who are older Americans on Medicare than the traditional version of Medicare; and the question of are people getting enough access to mental health care? And I guess what struck me is that there’s been so much attention lately to the question of access to mental health services for younger Americans, and this looked at the question of access to mental health services for older Americans. And what this story, based on a study, talks about is that the study found that more than half of the counties, the researchers who did this study found, is that those counties did not have a single psychiatrist participating in Medicare Advantage and that a lot of these plans have what’s called “narrow” or “skinny” networks, where a very small fraction of the available psychiatrists in a community were in that plan’s network. Now, [there are] people who are criticizing that study saying, well, you can’t look at just psychiatrists; there are other people who provide competent mental health care. But I think it just raises the question of who is getting what they need.
Rovner: Indeed. Well, my story this week is also about just plain good reporting. It’s called “Doctor Lands in the Doghouse After Giving Covid Vaccine Waivers Too Freely.” It’s by Brett Kelman of KFF Health News. But it’s about some old-fashioned reporting by another outlet, Nashville’s NewsChannel 5. It seemed that during the height of the covid vaccine rollout, when lots of places were requiring proof of vaccines and lots of people didn’t want to get them, the doctor in question, named Robert Coble, was providing waivers through a website without much —OK, any — oversight. How did they prove it? By obtaining a waiver for a reporter’s black Labrador retriever, Charlie. Earlier this spring, Coble quietly surrendered his medical license to the state Department of Health. Journalism works. OK, that is our show for this week. As always, 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. Special thanks, as always, to our producer, Francis Ying. Also as always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can still tweet me. I’m @jrovner. I’m on Threads too, @julie.rovner.
Rovner: Amy.
Goldstein: I’m @goldsteinamy.
Rovner: Rachel.
Cohrs: I’m @rachelcohrs on Twitter and @rachelcohrsreporter on Threads.
Rovner: Alice.
Ollstein: @AliceOllstein.
Rovner: We will be back in your feed next week. Until then, be healthy.
Credits
Francis Ying
Audio producer
Emmarie Huetteman
Editor
To hear all our podcasts, click here.
And subscribe to KFF Health News’ ‘What the Health?’ on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
USE OUR CONTENT
This story can be republished for free (details).
1 year 11 months ago
Courts, Health Care Costs, Health Industry, Insurance, Medicaid, Medicare, Multimedia, Biden Administration, Contraception, Drug Costs, FDA, KFF Health News' 'What The Health?', Podcasts, Pregnancy, Women's Health
As Low-Nicotine Cigarettes Hit the Market, Anti-Smoking Groups Press for Wider Standard
The idea seems simple enough.
Preserve all the rituals of smoking: Light up a cigarette, inhale the smoke, including the nasty stuff that can kill you, and exhale. But remove most of the nicotine, the chemical that makes tobacco so darn hard to quit, to help smokers smoke less.
The idea seems simple enough.
Preserve all the rituals of smoking: Light up a cigarette, inhale the smoke, including the nasty stuff that can kill you, and exhale. But remove most of the nicotine, the chemical that makes tobacco so darn hard to quit, to help smokers smoke less.
The Food and Drug Administration has been contemplating that strategy for at least six years as one way to make it easier for smokers to cut back, if not quit entirely. Less than two years ago, it authorized 22nd Century Group, a publicly traded plant biotech company based in Buffalo, New York, to advertise its proprietary low-nicotine cigarettes as modified-risk tobacco products.
Now, the first authorized cigarettes with 95% less nicotine than traditional smokes are coming to California, Florida, and Texas in early July, after a year of test-marketing in Illinois and Colorado. It’s part of an aggressive rollout by 22nd Century that, by year’s end, could bring its products to 18 states — markets that together account for more than half of U.S. cigarette sales.
But anti-smoking groups oppose greenlighting 22nd Century’s products. Instead, they urge federal regulators to expand on their original plan of setting a low-nicotine standard for all combustible cigarettes to make them minimally or nonaddictive. They expect the FDA to take the next step in that industrywide regulatory process as early as this fall.
“Unless and until there is a categorywide requirement that nicotine goes down to low, nonaddictive levels, this is not going to make a difference,” said Erika Sward, a spokesperson for the American Lung Association.
Major tobacco companies Altria, R.J. Reynolds, and ITG Brands did not respond to requests for comment.
Cigarette smoking is estimated to cause more than 480,000 deaths a year in the U.S., including from secondhand smoke, and contributes to tobacco use being the leading preventable cause of death nationally. In 2018, then-FDA Commissioner Scott Gottlieb wrote that setting a maximum nicotine level “could result in more than 8 million fewer tobacco-caused deaths through the end of the century – an undeniable public health benefit.”
The FDA reasoned that people would collectively smoke fewer cigarettes and have less exposure to the deadly toxins that are still present in low-nicotine cigarettes.
22nd Century says it used a patent-protected process to control nicotine biosynthesis in the tobacco plant, enabling it to create a pack of cigarettes with about as much nicotine as one Marlboro. It says generally that it uses “modern plant breeding technologies, including genetic engineering, gene-editing, and molecular breeding.”
Keeping 5% of the nicotine is enough to prevent smokers from seeking more to satisfy their craving, said John Miller, president of 22nd Century’s smoking division.
“There’s just enough in there that your brain thinks it’s getting it, but it’s not,” Miller said. “That was really one of the reasons we got to these levels of nicotine, is because you don’t have that additional smoking.”
Miller said the low-nicotine cigarettes can help some smokers cut back or quit, perhaps in conjunction with a nicotine patch or gum, when they’ve tried and failed with other stop-smoking programs.
Campaign for Tobacco-Free Kids President Matthew L. Myers supports the development of an industrywide low-nicotine standard, saying the concept would work only if consumers no longer had the alternative of a higher-nicotine cigarette.
“The concern with a product that’s still addictive, but delivers low levels of nicotine, in fact is that consumers will smoke more, because the evidence shows that somebody who’s addicted will smoke enough to satisfy their craving,” Myers said.
Both the FDA and anti-smoking groups cited studies that found lower levels of nicotine don’t prompt smokers to smoke more to reach the same nicotine levels. But those studies assumed smokers wouldn’t have a high-nicotine alternative, anti-smoking groups and researchers said.
Allowing low-nicotine cigarettes while conventional cigarettes remain available may be a public health detriment if they discourage smokers from quitting entirely or encourage others to start smoking because they think there’s a safe way to experiment with cigarettes, the Campaign for Tobacco-Free Kids and several health associations wrote in a letter urging the FDA to reverse its 22nd Century decision.
22nd Century’s cigarettes are still dangerous, and consumers must substantially cut back or quit smoking to get health advantages. But anti-smoking groups fear many smokers won’t understand that.
“If people are looking at this as a magic bullet and are still continuing their tobacco use, they are not doing anything to change their risk,” said Sward, of the lung association.
Anti-smoking groups particularly object to allowing 22nd Century to market menthol cigarettes even as the FDA is considering outlawing such cigarettes nationwide.
FDA spokesperson Abby Capobianco confirmed that 22nd Century has the only FDA-authorized low-nicotine cigarette but did not respond to requests for comment on the FDA’s plans for regulating nicotine in cigarettes.
California already outlaws menthol flavoring, and Miller said the company won’t challenge that state’s ban and won’t sell its menthol cigarettes in California.
But Miller hopes the company will eventually win an exemption from any federal ban, in part, he said, because more than half of menthol smokers are likely to switch to conventional cigarettes.
“That’s not what the FDA wants to happen,” Miller said. “They need an offramp for these menthol smokers and ours is obviously the natural.”
The company is expanding into California, Florida, and Texas because of the nation-leading size of their smoking populations. It previously announced plans to also begin selling its very low-nicotine, or VLN, cigarettes this year in Arizona, New Mexico, and Utah, and it may move into 10 more states.
The company is prioritizing seven states that offer tax incentives for products the FDA has said reduce tobacco risk, believing its cigarettes will have a price advantage over others in Colorado, Connecticut, Kentucky, Michigan, North Carolina, New Mexico, and Utah. Miller said the company may lobby California lawmakers to add similar incentives as part of the state’s extensive efforts to discourage smoking, which still addicts 10% of its residents.
Miller declined to disclose the company’s market share from the two test states but said sales were above expectations.
“If we can get this to the level of, like, a nonalcoholic beer — you know, 3% to 5% of the category — it’s a game changer,” Miller said. “We know that there’s a latent demand in the market for this product.”
This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
USE OUR CONTENT
This story can be republished for free (details).
1 year 11 months ago
california, Public Health, States, Arizona, Colorado, Connecticut, FDA, Florida, Illinois, Kentucky, Michigan, New Mexico, New York, North Carolina, texas, Utah, Vaping
FDA Approves Roche Lymphoma Drug, Bringing Competition to New AbbVie Med
The FDA approved Roche’s Columvi as a third-line treatment for a type of blood cancer called diffuse large B-cell lymphoma. This new Roche drug will compete against Epkinly, AbbVie’s recently approved DLBCL drug.
The FDA approved Roche’s Columvi as a third-line treatment for a type of blood cancer called diffuse large B-cell lymphoma. This new Roche drug will compete against Epkinly, AbbVie’s recently approved DLBCL drug.
1 year 12 months ago
BioPharma, Daily, legal, Pharma, Top Story, bispecific antibody, Clinical Trials, diffuse large B-cell lymphoma, FDA, Genentech, Roche
AbbVie’s Rinvoq Lands FDA Approval as First Oral Drug for Crohn’s Disease
FDA approval of blockbuster AbbVie drug Rinvoq makes it the first oral therapy for moderately to severely active Crohn’s disease. The regulatory nod is the seventh for the drug, which belongs to a class of therapies called JAK inhibitors.
FDA approval of blockbuster AbbVie drug Rinvoq makes it the first oral therapy for moderately to severely active Crohn’s disease. The regulatory nod is the seventh for the drug, which belongs to a class of therapies called JAK inhibitors.
2 years 3 weeks ago
BioPharma, Daily, Pharma, Top Story, AbbVie, biopharma nl, Clinical Trials, Crohn's disease, FDA, North Chicago, Rinvoq
The Crisis Is Officially Ending, but Covid Confusion Lives On
The Host
Julie Rovner
KFF Health News
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.
The formal end May 11 of the national public health emergency for covid-19 will usher in lots of changes in the way Americans get vaccines, treatment, and testing for the coronavirus. It will also change the way some people get their health insurance, with millions likely to lose coverage altogether.
Meanwhile, two FDA advisory committees voted unanimously this week to allow the over-the-counter sale of a specific birth control pill. Advocates of making the pill easier to get say it could remove significant barriers to the use of effective contraception and prevent thousands of unplanned pregnancies every year. The FDA, however, must still formally approve the change, and some of its staff scientists have expressed concerns about whether teenagers and low-literacy adults will be able to follow the directions without the direct involvement of a medical professional.
This week’s panelists are Julie Rovner of KFF Health News, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico, Tami Luhby of CNN, and Margot Sanger-Katz of The New York Times.
Panelists
Joanne Kenen
Johns Hopkins Bloomberg School of Public Health and Politico
Tami Luhby
CNN
Margot Sanger-Katz
The New York Times
Among the takeaways from this week’s episode:
- The formal public health emergency may be over, but covid definitely is not. More than 1,000 people in the United States died of the virus between April 19 and April 26, according to the Centers for Disease Control and Prevention. While most Americans have put covid in their rearview mirrors, it remains a risk around the country.
- The Senate Finance Committee held a hearing on “ghost networks,” lists of health professionals distributed by insurance companies who are not taking new patients or are not actually in the insurance company’s network. Ghost networks are a particular problem in mental health care, where few providers take health insurance at all.
- Another trend in the business of health care is primary care practices being bought by hospitals, insurance companies, and even Amazon. This strategy was popular in the 1990s, as health systems sought to “vertically integrate.” But now the larger entities may have other reasons for having their own networks of doctors, including using their patients to create revenue streams.
- Court battles continue over the fate of the abortion pill mifepristone, as a federal appeals court in New Orleans prepares to hear arguments about a lower-court judge’s ruling that would effectively cancel the drug’s approval by the FDA. In West Virginia, the maker of the generic version of the drug is challenging the right of the state to ban medication approved by federal officials. At the same time, a group of independent abortion clinics from various states is suing the FDA to drop restrictions on how mifepristone can be prescribed, joining mostly Democratic-led states seeking to ensure access to the drug.
Plus for “extra credit” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: Slate’s “Not Every Man Will Be as Dumb as Marcus Silva,” by Moira Donegan and Mark Joseph Stern.
Joanne Kenen: The Baltimore Banner’s “Baltimore Isn’t Accessible for People With Disabilities. Fixing It Would Cost Over $650 Million,” by Hallie Miller and Adam Willis.
Tami Luhby: CNN’s “Because of Florida Abortion Laws, She Carried Her Baby to Term Knowing He Would Die,” by Elizabeth Cohen, Carma Hassan, and Amanda Musa.
Margot Sanger-Katz: The New Yorker’s “The Problem With Planned Parenthood,” by Eyal Press.
Also mentioned in this week’s episode:
- CNN’s “Here’s How the End of the Covid-19 Public Health Emergency Affects You,” by Tami Luhby and Alex Leeds Matthews.
- The New York Times’ “Corporate Giants Buy Up Primary Care Practices at Rapid Pace,” by Reed Abelson.
- Vox’s “Independents Back Abortion Rights. They’re Less Sure Democrats Do,” by Rachel M. Cohen.
Click to open the transcript
Transcript: The Crisis Is Officially Ending, but Covid Confusion Lives On
[Editor’s note: This transcript, generated using transcription software, has been edited for style and clarity.]
Julie Rovner: Hello and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent at KFF Health News. And I’m joined by some of the best and smartest health reporters in Washington. We are taping this week on Thursday, May 11, at 10:30 a.m. As always, news happens fast and things might have changed by the time you hear this. So here we go. We are joined today via video conference by Tami Luhby, of CNN.
Tami Luhby: Hello.
Rovner: Margot Sanger Katz, The New York Times.
Sanger-Katz: Good morning.
Rovner: And Joanne Kenen, of the Johns Hopkins Bloomberg School of Public Health and Politico.
Joanne Kenen: Hi, everybody.
Rovner: So the news on the debt ceiling standoff, just so you know, is that there is no news. Congressional leaders and White House officials are meeting again on Friday, and we still expect to not see this settled until the last possible minute. But there was plenty of other health news. We will start with the official end of the U.S. public health emergency for covid. We have talked at some length about the Medicaid unwinding that’s now happening and a potential to end some telehealth service reimbursement. But there’s a lot more that’s going away after May 11. Tami, you’ve been working to compile everything that’s about to change. What are the high points here?
Luhby: Well, there are a lot of changes depending on what type of insurance you have and whether we’re talking about testing, treatment, or vaccines. So I can give you a quick rundown. We wrote a visual story on this today. If you go to CNN.com, you’ll find it on the homepage right now.
Rovner: I will link to it in the show notes for the podcast.
Luhby: Basically, many people will be paying more for treatments and for tests. However, vaccines will generally remain free for almost everyone. And basically, if you look at our story, you’ll see the color-coded guide as to how it may impact you. But basically, testing — at-home tests are no longer guaranteed to be free. So if you’ve been going to your CVS or somewhere else to pick up your eight tests a month, your insurer may opt to continue providing it for free, but I don’t think many will. And then for lab tests, again, it really depends. But if you have Medicaid, all tests will be free through 2024. However, if you have private insurance or Medicare, you will probably have to start paying out-of-pocket for tests that are ordered by your provider. Those deductibles, those pesky deductibles, and copays or coinsurance will start kicking in again. And for treatments, it’s a little bit different again. The cost will vary by treatment if you have Medicare or private insurance. However, Paxlovid and treatments that are purchased by the federal government, such as Paxlovid, will be free as long as supplies last. Now, also, if you’re uninsured, there is a whole different situation. It’ll be somewhat more difficult for them. But there are still options. And, you know, the White House has been working to provide free treatments and vaccines for them.
Rovner: So if you get covid, get it soon.
Luhby: Like today. Right, exactly. Yeah, but with vaccines, even though, again, they’re free as long as the federal supplies last — but because of the Affordable Care Act, the CARES Act, and the Inflation Reduction Act, people with private insurance, Medicare, and Medicaid will actually continue to be able to get free vaccines after the federal supplies run out.
Rovner: After May 11.
Luhby: It’s very confusing.
Rovner: It is very confusing. That’s why you did a whole graphic. Joanne, you wanted to add something.
Kenen: And the confusion is the problem. We have lots of problems, but, like, last week, we talked a little bit about this. You know, are we still in an emergency? We’re not in an emergency the way we were in 2020, 2021, but it’s not gone. We all know it’s much, much better, but it’s not gone. And it could get worse again, particularly if people are confused, if people don’t know how to test, if people don’t know that they can still get things. The four of us are professionals, and, like, Tami’s having to read this complicated color-coded chart — you know, you get this until September 2024, but this goes away in 2023. And, you know, if you have purple insurance, you get this. And if you have purple polka-dotted insurance, you get that. And the lack of clarity is dangerous, because if people don’t get what they’re eligible for because they hear “emergency over, everything — nothing’s free anymore” — we’re already having trouble with uptake. We don’t have enough people getting boosters. People don’t know that they can get Paxlovid and that it’s free and that it works. We are still in this very inadequate response. We’re not in the terrifying emergency of three years ago, but it’s not copacetic. You know, it’s not perfect. And this confusion is really part of what really worries me the most. And the people who are most likely to be hurt are the people who are always most likely to be hurt: the people who are poor, the people who are in underserved communities, the people who are less educated, and it’s disproportionately people in minority communities. We’ve seen this show before, and that’s part of what I worry about — that there’s a data issue that we’ll get to whenever Julie decides to get to it, right?
Rovner: Yeah, I mean, and that’s the thing. With so much of the emergency going away, we’re not really going to know as much as we have before.
Sanger-Katz: In some ways, how you feel about this transition really reflects how you feel about the way that our health care system works in general. You know, what happened for covid is —and I’m oversimplifying a little bit — is we sort of set up a single-payer system just for one disease. So everyone had access to all of the vaccines, everyone had access to all of the tests, everyone had access to all of the treatments basically for free. And we also created this huge expansion of Medicaid coverage by no longer allowing the states to kick people out if they no longer seem to be eligible. So we had the kind of system that I think a lot of people on the left would like to see, not just for one disease but for every disease, where you have kind of more universal coverage and where the cost of obtaining important treatments and prevention is zero to very low. And this is definitely going to be a bumpy transition, but it’s basically a transition to the way our health care system works for every other disease. So if you are someone who had some other kind of infectious disease or a chronic disease like cancer, rheumatoid arthritis, whatever, you’ve been sort of dealing with all of this stuff the whole time — that you have to pay for your drugs; that, you know, that testing is expensive; that it’s confusing where you get things; that, you know, there’s a lot of complexity and hoops you have to jump through; that a lot depends on what kind of insurance you have; that what kind of insurance you can get depends on your income and other demographic characteristics. And so I find this transition to be pretty interesting because it seems like it would be weird for the United States to just forever have one system for this disease and another system for every other disease. And of course, we do have this for people who are experiencing kidney disease: They get Medicare, they get the government system, regardless of whether they would otherwise be eligible for Medicare.
Rovner: We should point out that Congress did that in 1972. They haven’t really done it since.
Kenen: And when it was much more rare than it was today.
Rovner: And when people didn’t live very long with it mostly.
Kenen: We didn’t have as much diabetes either.
Sanger-Katz: But anyway, I just think this transition kind of just gives us a moment to reflect on, How does the system work in general? How do we feel about how the system works in general? Are these things good or bad? And I agree with everything that Joanne said, that the confusion around this is going to have public health impacts as relates to covid. But we have lots of other diseases where we just basically have the standard system, and now we’re going to have the standard system for covid, too.
Kenen: You could have gone to the hospital with the bad pneumonia and needed oxygen, needed a ventilator, and when they tested you, if you had covid, it was all free. And if you had, you know, regular old-fashioned pneumonia, you got a bill. I agree with everything Margot said, but it’s even that silly. You could have had the same symptoms in your same lungs and you had two different health care systems and financing systems. None of us have ever thought anything made sense.
Rovner: Yes, well, I actually —
Kenen: That’s why we have a podcast. Otherwise, you know —
Sanger-Katz: And also the way that the drugs and vaccines were developed was also totally different, right? With the government deeply involved in the technology and development, you know, funding the research, purchasing large quantities of these drugs in bulk in advance. I mean, this is just not the way that our system really works for other diseases. It’s been a very interesting sort of experiment, and I do wonder whether it will be replicated in the future.
Luhby: Right. But it was also clear that this is not the beginning of the pushback. I mean, Congress has not wanted to allocate more money, you know, and there’s been a lot of arguments and conflicts over the whole course of this so-called single-payer system, or this more flexible system. So the U.S.’ approach to health care has been pushing its way in for many months.
Rovner: I naively, at the beginning of the pandemic, when we first did this and when the Republicans all voted for it, it’s like, let’s have the federal government pay the hospitals for whatever care they’re providing and make everything free at point of service to the patient — and I thought, Wow, are we going to get used to this and maybe move on? And I think the answer is exactly the opposite. It’s like, let’s get rid of it as fast as we possibly can.
Kenen: There’s money that the government has put in. I believe it is $5 billion into the next generation of vaccines and treatments, because the vaccine we have has certainly saved many lives. But as we all know, it’s not perfect. You know, it’s preventing death, but not infection. It’s not ending circulation of the disease. So we need something better. This debt ceiling fight, if the people in the government could spend all $5 billion today — like we were joking, if you want to get covid, if you’re going to get covid, get it today — I mean, if they could, they would spend all $5 billion of it today, too, because that could be clawed back. I mean, that’s — it’s going to be part of the coming fight.
Luhby: But the question is, even if they develop it, will anyone take it, or will enough people take it? That’s another issue.
Rovner: Well, since we’re sort of on the subject, I’m going to skip ahead to what I was going to bring up towards the end, which I’m calling “This Week in Our Dysfunctional Health System.”
Kenen: We could call it that way every week.
Rovner: Yes, that’s true. But this is particularly about how our health system doesn’t work. First up is “ghost networks.” Those are where insurers provide lists of health care providers who are not, in fact, available to those patients. A quote “secret shopper survey” by the staff of the Senate Finance Committee found that more than 80% of mental health providers found in insurance directories in 12 plans from six states were unreachable, not accepting new patients, or not actually in network. This is not a new problem. We’ve been hearing about it for years and years. Why does it persist? One would think that you could clean up your provider directory. That would be possible, right?
Kenen: Didn’t they legislate that, though? Didn’t they say a few years ago you have to clean it up? I mean, there are going to be some mistakes because there’s, you know, many, many providers and people will make changes or leave practices or … [unintelligible] … jobs or whatever. But I thought that they had supposedly, theoretically, taken care of this a couple years ago in one of the annual regulations for ACA or something.
Rovner: They supposedly, theoretically, took care of the hospitals reporting their prices in a way that consumers can understand, too. So we’ve discovered in our dysfunctional health care system that Congress passing legislation or HHS [the Department of Health and Human Services] putting out rules doesn’t necessarily make things so.
Kenen: Really?
Rovner: Yeah. I just — this was one that I had thought, Oh, boy, I have a whole file on that from like the 1990s.
Sanger-Katz: It’s a huge problem, though. I mean —
Rovner: Oh, it is.
Sanger-Katz: You know, we have a system where, for large groups of Americans, you are expected to shop for a health insurance plan. If you’re purchasing a marketplace plan for yourself, if you are purchasing a Medicare Advantage plan when you become eligible for Medicare, and in many cases, if you have a choice of employer plans, you know, you’re supposed to pick the plan that’s best for you. And we have a system that tells people that having those kinds of choices is good and maximizes the benefits to people, to be able to pick the best plan. But for a lot of people, being able to have the doctors and hospitals that they use or to have a choice of a wide range of doctors for various problems, including mental health services, is a huge selling point of one plan versus another. And again, you have these ghost networks, when you have this lack of transparency and accuracy of this information, it just causes people to be unable to make those good choices and it undermines the whole system of market competition that underpins all of this policy design. I think you can argue that there are not a million gazillion people who are actually shopping on the basis of this. But I do think that knowing whether your medical providers are covered when you’re choosing a new health care plan is actually something that a lot of people do look into when they are choosing a health insurance plan. And discovering that a doctor that you’ve been seeing for a long time and whose relationship you really value and whose care has been important to you is suddenly dishonestly represented as a part of an insurance plan that you’ve selected is just, you know, it’s a huge disappointment. It causes huge disruptions in people’s care. And I think the other thing that this study highlighted is that health insurance coverage for mental health services continues to be a very large problem. There has been quite a lot of legislation and regulation trying to expand coverage for mental health care. But there are these kind of lingering problems where a lot of mental health care providers simply don’t accept insurance or don’t accept very many patients who have insurance. And so I think that this report did a good job of highlighting that place where I think these problems are even worse than they are with the health care system at large. It’s just very hard to find mental health care providers who will take your insurance.
Rovner: And I would say, when you’re in mental health distress or you have a relative who’s in mental health distress, the last thing you need is to have to call 200 different providers to find one who can help you.
Kenen: A lot of the ones that are taking insurance are these online companies, and the good thing is that they’re taking insurance and that there may be convenience factors for people, although there’s also privacy and other factors on the downside. But there have been reports about, your data is not private, and I have no idea how you find out which company is a good actor in that department and which company is just selling identifiable data. I mean, I think it was The Washington Post that had a story about that a couple of weeks ago. You know, you click in on something — straight to the data broker. So, yeah, you get insurance coverage, but at a different price.
Rovner: Well, overlaid over all of this is consolidation, this time at the primary care level of health care. Margot, your colleague Reed Abelson had a big story this week on primary care practices being bought up by various larger players in the health care industry, including hospitals, insurance companies, pharmacy chains, and even Amazon. These larger entities say this can act as a move towards more coordinated, value-based care, which is what we say we all want. But there’s also the very real possibility that these giant, vertical, mega medical organizations can just start to name their own price. I mean, this is something that the FTC [Federal Trade Commission] in theory could go after but has been kind of loath to and that Congress could go after but has also been kind of loath to.
Sanger-Katz: Yeah, in some ways we’ve seen this movie before. There was a big wave of primary care acquisitions that happened, I think, in the 1990s by hospitals. And the hospitals learned pretty quickly that primary care doctors are kind of a money-losing proposition, and they divested a lot. But I think what Reed documented so nicely is that the entities that are buying primary care now are more diverse and they have different business strategies. So it’s not just hospitals who are sort of trying to get more patients referred to their higher-profit specialists, but it’s also Medicare Advantage insurers who benefit from being able to tell the primary care doctors to diagnose their patients with lots of diseases that generate profits for the plan, and it’s other kinds of groups that see primary care as kind of the front door to other services that can be revenue-generating. And it’s very — it will be very interesting to see what the effects of these will be and whether these will turn out to be good business decisions for these new entities and of course also whether it will turn out to be good for patient care.
Rovner: Yeah, I remember in the 1990s when hospitals were buying up doctor practices, the doctors ended up hating it because they were asked to work much harder, see patients for a shorter period of time, and some of them actually — because they were now on salary rather than being paid for each patient — were cutting back on, you know, in general, on the amount of care they were providing. And that was what I think ended up with a lot of these hospitals divesting. It didn’t work out the way the hospitals hoped it would. But as you point out, Margot, this is completely different, so we will — we will see how this moves on. All right. Let’s go back a little bit. We’re going to talk about abortion in a minute. But first, something that could prevent a lot of unintended pregnancies: On Wednesday, an advisory committee for the Food and Drug Administration — actually two advisory committees — unanimously recommended that the agency approve an over-the-counter birth control pill. This has been a long time coming here in the U.S., even though pills like these are available without prescription in much of Europe and have been for years. But while the FDA usually follows the recommendations of its advisory committees, we know that some FDA scientists have expressed concerns about over-the-counter availability. So what’s the problem with giving women easier access to something that so many depend on?
Kenen: There are trade-offs. And there are — some of the scientists at the FDA are more conservative than others about, What if the woman doesn’t understand how to take the pill properly? Things like that. I mean, obviously, if we go the over-the-counter route, as other countries are doing, there have to be very simple, easy-to-understand explanations in multiple languages. Pharmacists should be able to explain it like, you know, “You have to take it every day, and you have to take it at approximately the same time every day,” and things like that. So, you know, obviously not taking it right doesn’t protect you as much as taking it right. But there are a lot of people who will be able to get it. You know, getting a prescription is not always the easiest thing in the world. Or if you’re lucky, you just click on something and somebody calls your doctor and gets you a refill. But that doesn’t always work and not everybody has access to that, and you have to still see your doctor sometimes for renewals. So if you’re a working person who doesn’t have sick leave and you have to take time off from work every three months to get a refill or you have to hire child care or you have to take three buses — you know, it takes a whole day, and then you sit in a waiting room at a clinic. I mean, our health system is not patient-friendly.
Rovner: I was going to say, to go back to what Tami was talking about earlier — if pills are available over the counter, it’s going to depend on, you know, what your insurance is like, whether you would get it covered.
Kenen: The cost.
Rovner: That’s right. And it could end up being —
Kenen: But I don’t think the FDA is concerned about that.
Rovner: No, they’re not. That’s not their job.
Kenen: The pill is pretty safe, and these are lower-dose ones than the pills that were invented, you know, 50 years ago. These are lower-dose, safer drugs with fewer side effects. But I mean, there’s concern about the rare side effect, there’s concern about people not knowing how to take it, all that kind of stuff. But Julie just mentioned the cost of coverage is a separate issue because under the ACA it’s covered. And if it becomes over the counter, the mechanism for getting that covered is, at this point, unclear.
Sanger-Katz: But we do have a system now where, for a lot of women, obtaining birth control pills depends on being able to get a doctor’s appointment on a regular basis. I think, you know, this is not standard practice, but I do think that there are a lot of OB-GYNs who basically won’t write you for a birth control pill unless you come in on a regular basis to receive other kinds of health screenings. And I think many of them do that with good intentions because they want to make sure that people are getting Pap smears and other kinds of preventive health services. But on the other hand, it does mean that there are a lot of women who, if they don’t have time or they can’t afford to come in for regular doctor’s appointments, lose access to birth control. And I think over-the-counter pills is one way of counteracting that particular problem.
Rovner: And I think that’s exactly why so many of the medical groups are urging this. During the more than a decade-long fight over making the morning-after pill over the counter, the big hang-up was what to do about minors. Even President Obama, a major backer of women’s reproductive health rights, seemed unhappy at the idea of his then-barely teenage daughters being able to get birth control so easily and without notifying either parent. It seems unimaginable that we’re not going to have that same fight here. I mean, literally, we spent six years trying to figure out what age teens could be to safely buy morning-after pills, which are high doses of basically these birth control pills. I’m actually surprised that we haven’t really seen the minor fight yet.
Kenen: I think everyone’s waiting for somebody else to do it first. I mean, like Julie, I wasn’t expecting to hear more about age limitations, and that’ll probably come up when the FDA acts, because I think the advisory committee just wanted to — they were pretty strong saying, “Yeah, make this OTC.”
Sanger-Katz: I also think the politics around emergency contraception are a little bit different because I think that, while physicians understand that those pills are basically just high-dose birth control pills and that they work in just the same way as typical contraception, I think there’s a perception among many members of the public that because you can take them after unprotected sex, that they might be something closer to an abortion. Now, that is not true, but because I think that is a common misperception, it does lead to more discomfort around the availability of those pills, whereas birth control pills — while I think there are some people who object to their wide dissemination and certainly some who are concerned about them in the hands of children, I think they are more broadly accepted in our society.
Rovner: We obviously are going to see, and we’ll probably see fairly soon. We’re expecting, I guess, a decision from the FDA this summer, although with the morning-after pill we expected a decision from FDA that lingered on for many months, in some cases many years.
Kenen: And I think it’s at least hypothetically possible that states will not do what the FDA says. Say the FDA says they can be over the counter with no age limitations. I can see that becoming a fight in conservative states. I mean, I don’t know exactly the mechanism for how that would fall, but I could certainly think that somebody is going to dream up a mechanism so that a 12-year-old can’t get this over the counter.
Rovner: I want to move to abortion because first up is the continuing question over the fate of the abortion pill, which we get to say at this point: not the same as the emergency contraceptive pill, which, as Margot said, is just high-dosage regular birth control pills. Needless to say, that’s the one that we’re having the current court action over. And there was even more action this week, although not from that original case, which will be heard by the Court of Appeals later in this month. In West Virginia, a judge declined to throw out a case brought by GenBioPro. They are the maker of the generic version of mifepristone, the abortion pill. That generic, which accounts for more than half the market, would be rendered unapproved even under the compromise position of the Court of Appeals because it was approved after the 2016 cutoff period. Remember, the Court of Appeals said, We don’t want to cancel the approval, but we want to roll it back to the date when FDA started to loosen the restrictions on it. So, in theory, there would be no generic allowed, but that’s actually not even what the West Virginia lawsuit is about; it’s about challenging the state’s total abortion ban as violating the federal supremacy of the FDA over state laws. Joanne, that’s what sort of you were talking about now with contraceptives, too. And this is the big unanswered question: Can states basically overrule the FDA’s approval and the FDA’s approval for even an age limit?
Kenen: Well, I mean, I’m not saying they can, but I am saying that I don’t know where the question will come down. Go back to the regular birth control; I can certainly see conservative states trying to put age limits on it. And I don’t know how that’ll play out legally. But this is a different issue, and this is why the abortion pill lawsuits are not just about the abortion pill. They’re about drug safety and drug regulation in this country. The FDA is the agency we charge with deciding whether drugs are safe and good for human beings, and not the system of politicians and state legislators in 50 different states replacing their judgment. So obviously, it’s more complicated, because it’s abortion, but one of several bottom lines in this case is who gets to decide: the FDA or state legislature.
Rovner: And right: Do states get to overrule what the federal Food and Drug Administration says? Well, I —
Kenen: Remember, some states have had — you know, California’s had stricter regulations on several health things, you know, and that’s been allowed that you could have higher ceilings for various health — you know, carcinogenics and so forth. But they haven’t fundamentally challenged the authority of the FDA.
Rovner: Yet. Well, since confusion is our theme of the week, also this week a group of independent abortion clinics led by Whole Woman’s Health, which operates in several states, filed suit against the FDA, basically trying to add Virginia, Kansas, and Montana to the other 18 states that sued to force FDA to further reduce the agency’s current restrictions on mifepristone. A federal judge in Washington state ruled — the same day that Texas judge did that mifepristone should have its approval removed — judge in Washington said the drug should become even more easily available. In the real world, though, this is just sowing so much confusion that nobody knows what’s allowed and what isn’t, which I think is kind of the point for opponents, right? They just want to make everybody as confused as possible, if they can’t actually ban it.
Sanger-Katz: I think they actually want to ban it. I mean, I think that’s their primary goal. I’m sure there are some that will settle for confusion as a secondary outcome. I think just this whole mess of cases really highlights what a weird moment we are, where we’re having individual judges and individual jurisdictions making determinations about whether or not the FDA can or can’t approve the safety and efficacy of drugs. You know, as Joanne said, we’ve just had a system in this country since the foundation of the FDA where they are the scientific experts and they make determinations and those determinations affect drug availability and legal status around the country. And this is a very unusual situation where we’re seeing federal courts in different jurisdictions making their own judgments about what the FDA should do. And I think the Texas judge that struck down the approval of mifepristone, at least temporarily, has come in for a lot of criticism. But what the judge in Washington state did is sort of a flavor of the same thing. It’s telling the FDA, you know, how they should do their business. And it’s a weird thing.
Rovner: It is. Well, one last thing this week, since we’re talking about confusion, and the public is definitely confused, according to two different polls that are out this week — on the one hand, a Washington Post-ABC News poll found that a full two-thirds of respondents say mifepristone, the abortion pill, should stay on the market, and more than half say they disagree with the Supreme Court’s overturn of Roe v. Wade, including 70% of independents and more than a third of Republicans. Yet, in focus groups in April, more than a third of independents couldn’t differentiate Democrats’ position on abortion from Republicans’. As reported by Vox, one participant said, quote, “I really haven’t basically heard anything about which party is leaning toward it and which one isn’t.” When pressed, she said, “If I had to guess, I would say Democrat would probably be against it and Republican would probably be for it.” Another participant said she thought that Joe Biden helped get the Supreme Court judges who overturned Roe. We really do live in a bubble, don’t we? I think that was sort of the most mind-blowing thing I’ve read since — all the months since Roe got overturned, that there are people who care about this issue who have no idea where anybody stands.
Sanger-Katz: I think it’s just a truth about our political system that there are a lot of Americans who are what the political scientists call low-information voters. These are people who are just not following the news very closely and not following politics very closely. And they may have a certain set of opinions about issues of the day, but I think it is a big challenge to get those people aware of where candidates stand on issues of concern to them and to get them activated. And it doesn’t really surprise me that independent voters are the ones who seem to be confused about where the parties are, because they’re probably the least plugged into politics generally. And so, for Democrats, it does seem like this lack of information is potentially an opportunity for them, because it seems like when you ask voters what they want on abortion, they want things that are more aligned with Democratic politicians’ preferences than Republicans’. And so it strikes me that perhaps some of those people in the focus group who didn’t know who stood for what, maybe those are gettable voters for the Democratic Party. But I think — you know, we’re about to go into a very heated campaign season, you know, as we go into the presidential primaries and then the general election in which there are going to be a lot of ads, a lot of news coverage. And, you know, I think abortion is very likely to be a prominent issue during the campaigns. And I think it is almost certainly going to be a major goal of the Biden presidential reelection campaign to try to make sure that these people know where Biden stands relative to abortion, because it is an issue that so many voters agree with him on.
Rovner: And it makes you see, I mean, there’s a lot of Republicans who are trying to sort of finesse this issue now and say, you know, “Oh, well, we’re going to restrict it, but we’re not going to ban it,” or, “We have all these exceptions” that are, of course, in practice, you can’t use. Obviously, these are the kinds of voters who might be attracted to that. So we will obviously see this as it goes on.
Kenen: But Julie, do you remember whether they were actually voters? Because I had the same reaction to you: like, of all the things to not be sure of, that one was pretty surprising. But we also know that in places like Kansas where, you know, where there are not that many Democrats, these referenda won. Voters have supported abortion rights in the 2022 elections and in these state referenda. So independents must be voting with the —
Rovner: I was going to say, I think if you’re doing —
Kenen: Something isn’t totally — something is not totally adding up there.
Rovner: If you’re doing a focus group for politics, one presumes that you get voters. So, I mean, I think that was — that was the point of the focus group. But yeah, it’s —
Kenen: Or people who say they’re voters.
Rovner: Or people who say they’re voters. That is a different issue. All right. Well, something not that confusing: Now it’s time for our extra credit segment. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Tami, why don’t you go first this week?
Luhby: OK. Well, I picked a story from CNN by my colleagues on the health team. It’s titled “Because of Florida Abortion Laws, She Carried Her Baby to Term Knowing He Would Die,” by Elizabeth Cohen, Carma Hassan, and Amanda Musa. And I have to say that when I first read this story, I couldn’t get through it, because it was so upsetting. And then when I selected it as an extra credit, I had to read it in full. But it’s about a family in Florida whose son was born without kidneys. They knew that he was going to die. And it’s about all of the effects from everything from, you know, the mother, Deborah Dorbert, on her physically and emotionally. But it also, you know, talked about the family and, you know, the effect on the marriage and the effect — which was just so upsetting — was on the 4-year-old son, who became very attached. I don’t think they even knew — well, it wasn’t a girl. It was actually a boy. But for some reason, this older son felt that it was a girl and just kept saying, like, “My sister is going to do X, Y, Z.” And, you know, how did the parents break it to him? Because he saw that his mother was, you know, pregnant and getting larger. And, you know, it was just figuring out how to break it to him that no baby was coming home. So the details are heart-wrenching. The quotes in the third paragraph: “‘He gasped for air a couple of times when I held him,’ said Dorbert. ‘I watched my child take his first breath, and I held him as he took his last one.’” So, you know, these are things that, you know — and we just talked about how the states are arguing over what exceptions there should be, if any, you know, and these are the stories that the legislators don’t think about when they pass these laws.
Rovner: I think I said this before because we’ve had a story like this almost every week. This one was particularly wrenching. But I think the one thing that all these stories are doing is helping people understand, particularly men, that there are complications in pregnancy, that they’re not that rare, that, you know, that they sort of throw off and say, “Oh, well, that’s, you know, one in a million,” — It’s not one in a million. It’s like one in a thousand. That’s a lot of people. So I mean, that’s why there are a lot of these stories, because there are a lot of pregnancies that don’t go as expected.
Luhby: Right. And it really shows the chilling effect on doctors because, you know, you would say, “Oh, it’s simple: life of the mother or, you know, life of the fetus” or something like that. That seems pretty straightforward, but it isn’t. And these doctors, in cases where, you know, other cases where it is the life of the mother, which seem, again, very straightforward, the doctors are not willing to do anything because they’re afraid.
Rovner: I know. Joanne.
Kenen: This is a story from The Baltimore Banner that has a very long title. It’s by Hallie Miller and Adam Willis, and it’s called “Baltimore Isn’t Accessible for People With Disabilities. Fixing It Would Cost Over $650 Million.” Baltimore is not that big a city. $650 million is a lot of curbs and barriers. And there’s also a lot of gun violence in Baltimore. If you drive around Baltimore, and I work there a few days a week, you see lots of people on walkers and scooters and wheelchairs because many of them are survivors of gun violence. And you see them struggling. And there were quotes from people saying they, you know, were afraid walking near the harbor that they would fall in because there wasn’t a path for them. It is not invisible, but we treat it like it’s invisible. And it’s been many years since the Americans with Disabilities Act was passed, and we still don’t have it right. It’s a — this one isn’t confusion like everything else we talked about today. I loved Margot’s phrase about confusion as a secondary outcome. I think you should write a novel with that title. But it’s — this isn’t confusion. This is just not doing the right thing for people who are — we’re just not protecting or valuing.
Rovner: And I’d say for whom there are laws that this should be happening. Margot.
Sanger-Katz: I had another story about abortion. This one was in The New Yorker, called “The Problem With Planned Parenthood,” by Eyal Press. The story sort of looked at Planned Parenthood, you know, which is kind of the largest abortion provider in the country. It’s — I mean, it’s really a network of providers. They have all these affiliates. They’re often seen as being more monolithic than perhaps they are. But this story argued that people who were operating independent abortion clinics, who do represent a lot of the abortion providers in the country as well, have felt that Planned Parenthood has been too cautious legally, too afraid of running afoul of state laws, and so that has led them to be very conservative and also too conservative from the perspective of business, and that there is a view that Planned Parenthood is not serving the role that it could be by expanding into areas where abortion is less available. I thought it was just interesting to hear these criticisms and hoped to understand that the community of abortion providers are, you know, they’re diverse and they have different perspectives on how abortion access should work and what kinds of services should be provided in different settings. And they also view each other as business competition in some cases. I mean, a lot of the complaints in this article had to do with Planned Parenthood opening clinics near to independent clinics and kind of taking away the business from them, making it harder for them to survive and operate. Anyway, I thought it was a very interesting window into these debates, and it did mesh with some of my reporting experience, particularly around the legal cautiousness. I did a story before the Dobbs decision came down from the Supreme Court where Planned Parenthood in several states had just stopped offering abortions even before the court had ruled, because they anticipated that the court would rule and they just didn’t want to make any mistake about running afoul of these laws such that, you know, women were denied care that was still legal in the days leading up to the Supreme Court decision.
Rovner: Yeah, it’s a really good story. Well, my story is kind of tangentially about abortion. It’s from Slate, and it’s called “Not Every Man Will Be as Dumb as Marcus Silva,” by Moira Donegan and Mark Joseph Stern. And it’s about a case from Texas, of course, that we talked about a couple of weeks ago, where an ex-husband is suing two friends of his ex-wife for wrongful death, for helping her get an abortion. Well, now the two friends have filed a countersuit claiming that the ex-husband knew his wife was going to have an abortion beforehand because he found the pill in her purse and he put it back so that he could use the threat of a lawsuit to force her to stay with him. It feels like a soap opera, except it is happening in real life. And my first thought when I read this is that it’s going to make some great episode of “Dateline” or “20/20.” That is our show, as always.
Kenen: Or, not “The Bachelor.”
Rovner: Yeah, but not “The Bachelor.” That is our show. As always, 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. Special thanks, as always, to our ever-patient producer, Francis Ying. Also, as always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me. I’m still there. I’m at @jrovner. Joanne?
Kenen: @JoanneKenen.
Rovner: Tami.
Luhby: @Luhby.
Rovner: Margot.
Sanger-Katz: @sangerkatz.
Rovner: We will be back in your feed next week, hopefully with a little less confusion. Until then, be healthy.
Credits
Francis Ying
Audio producer
Stephanie Stapleton
Editor
To hear all our podcasts, click here.
And subscribe to KFF Health News’ ‘What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
USE OUR CONTENT
This story can be republished for free (details).
2 years 1 month ago
COVID-19, Health Industry, Insurance, Multimedia, Pharmaceuticals, Public Health, Abortion, FDA, Hospitals, KFF Health News' 'What The Health?', Legislation, Podcasts, Women's Health
Marihuana legal es más potente que nunca pero no está bien regulada
La marihuana y otros productos que contienen THC, el principal ingrediente psicoactivo de la planta, se han vuelto más potentes y peligrosos a medida que la legalización los ha vuelto más accesibles.
Décadas atrás, el contenido de THC de la hierba solía ser inferior al 1,5%. Hoy, algunos productos tienen más de un 90%.
La marihuana y otros productos que contienen THC, el principal ingrediente psicoactivo de la planta, se han vuelto más potentes y peligrosos a medida que la legalización los ha vuelto más accesibles.
Décadas atrás, el contenido de THC de la hierba solía ser inferior al 1,5%. Hoy, algunos productos tienen más de un 90%.
La euforia de antaño ha dado paso a algo más alarmante. Cientos de miles de personas llegan a salas de emergencias por crisis relacionadas con la marihuana, y millones sufren trastornos psicológicos vinculados al consumo de cannabis, según investigaciones federales.
Pero los organismos reguladores no están a la altura.
En los estados que permiten la venta y el consumo de la marihuana y sus derivados, la protección al consumidor no es consistente.
“En muchos estados, los productos tienen una etiqueta de advertencia y poco más por parte de las entidades reguladoras”, dijo Cassin Coleman, vicepresidente del comité de asesoramiento científico de la Asociación Nacional de la Industria del Cannabis.
En general, el gobierno federal no ha intervenido. Sigue prohibiendo la marihuana como sustancia catalogada en la Lista 1 —como droga sin uso médico aceptado y con un alto riesgo de abuso— en virtud de la Ley de Sustancias Controladas (CSA). Pero en lo que respecta a la venta de cannabis, que muchos estados han legalizado, no regula características como la pureza o la potencia.
La Administración de Drogas y Alimentos (FDA) “básicamente se ha cruzado de brazos y no ha cumplido con su deber de proteger la salud pública”, afirmó Eric Lindblom, de la Facultad de Derecho de la Universidad de Georgetown que anteriormente trabajó en el Centro para Productos del Tabaco de la FDA.
La marihuana se ha transformado profundamente desde que generaciones de estadounidenses la usaron por primera vez.
El cannabis se cultiva para suministrar dosis mucho más altas de THC. En 1980, el contenido de THC de la marihuana confiscada era inferior al 1,5%. Hoy en día, muchas variedades de flores de cannabis —la materia vegetal que se puede fumar en un porro— tienen más de un 30% de THC.
Recientemente, en un dispensario de California el menú incluía una variedad con un 41% de THC.
La legalización también ha abierto la puerta a productos que se extraen de la marihuana pero que no siquiera parecidos: concentrados de THC aceitosos, cerosos o cristalinos que se calientan e inhalan mediante el vapeo o el dab, utilizando dispositivos parecidos a un soplete.
Los concentrados actuales pueden tener más de un 90% de THC. Algunos se anuncian como THC casi puro.
Pocos personifican la expansión de la marihuana de forma tan clara como John Boehner, ex presidente de la Cámara de Representantes de Estados Unidos. El republicano de Ohio se opuso durante mucho tiempo a la marihuana y, en 2011, se declaró “inalterablemente contrario” a su legalización.
Ahora forma parte del consejo directivo de Acreage Holdings, un productor de derivados de la marihuana.
Y Acreage Holdings ilustra la evolución del sector. Su marca Superflux comercializa un producto para vapear —”resina pura en un formato cómodo e instantáneo”— y concentrados como “budder”, “sugar”, “shatter” y “wax”. La empresa anuncia su concentrado de “THCa cristalino” como “lo último en potencia”.
Según el Instituto Nacional sobre el Abuso de Drogas, las concentraciones más elevadas entrañan mayores riesgos. “Los riesgos de dependencia física y adicción aumentan con la exposición a altas concentraciones de THC, y las dosis más altas de THC tienen más probabilidades de producir ansiedad, agitación, paranoia y psicosis”, se explica en su sitio web.
En 2021, 16,3 millones de personas en Estados Unidos —el 5,8% de las personas de 12 años en adelante— habían sufrido un trastorno por consumo de marihuana en el último año, según una encuesta publicada en enero por el Departamento de Salud y Servicios Humanos (HHS).
Esta cifra es muy superior a la suma de los trastornos por consumo de cocaína, heroína, metanfetamina, estimulantes de venta bajo receta, como Adderall, o analgésicos recetados, como fentanilo y OxyContin.
Otras drogas son más peligrosas que la marihuana, y la mayoría de las personas afectadas por su consumo padecieron un caso leve. Pero aproximadamente 1 de cada 7 —más de 2,6 millones de personas— padecieron un caso grave, según la encuesta federal.
La mayoría de los médicos equiparan el término “trastorno grave por consumo de sustancias” con la adicción, señaló Wilson Compton, subdirector del Instituto Nacional sobre el Abuso de Drogas.
El trastorno por consumo de cannabis “puede ser devastador”, afirmó Smita Das, psiquiatra de Stanford y presidenta de un consejo sobre adicciones de la Asociación Americana de Psiquiatría.
Das dijo que ha visto vidas destrozadas por el cannabis: personas de éxito que han perdido familias y trabajos. “Se encuentran en una situación en la que no saben cómo han llegado, porque sólo era un porro, sólo era cannabis, y no se suponía que el cannabis les creara adicción”, explicó Das.
Entre los diagnósticos médicos atribuidos a la marihuana figuran la “dependencia del cannabis con trastorno psicótico con delirios” y el síndrome de hiperémesis cannabinoide, una forma de vómito persistente.
Se estima que unas 800,000 personas realizaron visitas a emergencias relacionadas con la marihuana en 2021, según un estudio del gobierno publicado en diciembre de 2022.
Derecho a desintoxicación.
Un padre de Colorado pensó que era cuestión de tiempo para que el cannabis matara a su hijo.
En la primavera de 2021, el adolescente pasó un semáforo en rojo, chocó contra otro auto —resultando heridos él y el otro conductor— y huyó del lugar, según recordó el padre en una entrevista.
En los restos del accidente, el padre encontró porros, envases vacíos de un concentrado de THC de alta potencia conocido como “wax” y un vaporizador de THC.
En el teléfono móvil de su hijo descubrió mensajes de texto y decenas de referencias al “dabbing” y a la hierba. El adolescente dijo que había estado fumando antes del accidente y que intentó suicidarse.
Semanas después, la policía ordenó su ingreso involuntario en un hospital para una evaluación psiquiátrica. Según un informe policial, creía que lo perseguían francotiradores de un cártel de drogas.
El médico que evaluó al adolescente le diagnosticó “abuso de cannabis”.
“Deja de consumir dabs o wax, ya que pueden volverte extremadamente paranoico”, escribió el médico. “Vete directamente al programa de desintoxicación que elijas”.
Según el relato del padre, en los dos últimos años el adolescente sufrió varias retenciones involuntarias, docenas de encuentros con la policía, repetidos encarcelamientos y una serie de estadías en centros de tratamiento hospitalario.
A veces parecía fuera de la realidad, y enviaba mensajes de texto diciendo que Dios le hablaba y le daba superpoderes.
Los daños también fueron económicos. Los reclamos al seguro médico por su tratamiento ascendieron a casi $600,000 y los gastos de la familia llegaron a casi $40,000 hasta febrero.
En las entrevistas para este artículo, el padre habló bajo condición de anonimato para no perjudicar la recuperación de su hijo.
Está convencido de que la enfermedad mental de su hijo fue el resultado del consumo de drogas. Dijo que los síntomas remitían cuando su hijo dejaba de consumir THC y volvían cuando usaba de nuevo.
Su hijo tiene ahora 20 años, ha dejado la marihuana y le va bien, dijo el padre, y añadió: "No me cabe la menor duda de que el consumo de cannabis fue lo que le causó la psicosis, los delirios y la paranoia".
Regulación estatal desigual
Ahora, el uso médico de la marihuana es legal en 40 estados y el Distrito de Columbia, y el uso recreativo o para adultos es legal en 22 estados más el Distrito de Columbia, según MJBizDaily, una publicación especializada.
Al principio de la pandemia de covid-19, mientras gran parte de Estados Unidos cerró sus negocios, los dispensarios de marihuana siguieron abiertos. Muchos estados los declararon negocios esenciales.
Pero sólo dos estados que permiten el uso para adultos, Vermont y Connecticut, han puesto límites al contenido de THC —30% para la flor de cannabis y 60% para los concentrados de THC— y eximen de los límites a los cartuchos precargados, dijo Gillian Schauer de la Asociación de Reguladores de Cannabis, un grupo de reguladores estatales.
Algunos estados limitan el número de onzas o gramos que los consumidores pueden comprar. Sin embargo, incluso un poco de marihuana puede equivaler a mucho THC, apuntó Rosalie Liccardo Pacula, profesora de políticas de salud, economía y derecho en la Universidad del Sur de California.
Algunos estados sólo permiten el uso médico de productos con bajo contenido de THC; por ejemplo, en Texas, las sustancias que no contienen más de un 0,5% de THC en peso. Y algunos estados exigen etiquetas de advertencia. En Nueva Jersey, los productos de cannabis con más de un 40% de THC deben declarar: "Este es un producto de alta potencia y puede aumentar el riesgo de psicosis".
La normativa sobre marihuana de Colorado tiene más de 500 páginas. Sin embargo, se enfatizan los límites de las protecciones al consumidor: "Este producto se ha producido sin supervisión reglamentaria en materia de salud, seguridad o eficacia".
Determinar las normas adecuadas puede no ser sencillo. Por ejemplo, las etiquetas de advertencia podrían proteger a la industria de la marihuana de su responsabilidad, al igual que hicieron con las empresas tabacaleras durante años. Poner un tope a la potencia podría limitar las opciones de las personas que toman dosis elevadas para aliviar problemas médicos.
En general, en el ámbito estatal, la industria del cannabis ha frenado los esfuerzos reguladores argumentando que unas normas onerosas dificultarían la competencia entre las empresas legítimas y las ilícitas, explicó Pacula.
Pacula y otros investigadores han pedido al gobierno federal que intervenga.
Meses después de terminar su mandato como comisionado de la FDA, Scott Gottlieb hizo un llamamiento similar.
Al quejarse de que los estados habían llegado "muy lejos mientras el gobierno federal permanecía al margen", Gottlieb pidió "un esquema nacional uniforme para el THC que proteja a los consumidores."
Eso fue en 2019 y poco ha cambiado desde entonces.
¿Dónde está la FDA?
La FDA supervisa los alimentos, los medicamentos recetados, los de venta libre y los dispositivos médicos. Regula el tabaco, la nicotina y los vapes de nicotina. Supervisa las etiquetas de advertencia del tabaco. En interés de la salud y la seguridad públicas, también regula los productos botánicos, productos médicos que pueden incluir material vegetal.
Sin embargo, cuando se trata de la marihuana para fumar, los concentrados de THC derivados del cannabis que se vapean o dabean y los comestibles infundidos con THC, la FDA parece estar muy al margen.
La marihuana medicinal que se vende en los dispensarios no está aprobada por la FDA. La agencia no ha avalado su seguridad o eficacia ni ha determinado la dosis adecuada. No inspecciona las instalaciones donde se producen los productos ni evalúa el control de calidad.
La agencia sí invita a los fabricantes a someter los productos del cannabis a ensayos clínicos y a su proceso de aprobación de medicamentos.
El sitio web de la FDA señala que el THC es el ingrediente activo de dos medicamentos aprobados por la FDA para el tratamiento del cáncer. Aparentemente, sólo por eso la sustancia está bajo la jurisdicción de la FDA.
La FDA tiene "todo el poder que necesita para regular de forma mucho más eficaz los productos de cannabis legalizados por los estados", afirmó Lindblom, ex funcionario de la agencia.
Al menos públicamente, la FDA no le ha prestado atención a los concentrados de THC derivados del cannabis o la hierba fumada en porros, sino más bien en otras sustancias: una variante del THC derivada del cáñamo, que el gobierno federal ha legalizado, y un derivado diferente del cannabis llamado cannabidiol o CBD, que se ha comercializado como terapéutico.
"La FDA se ha comprometido a vigilar el mercado, identificar los productos de cannabis que plantean riesgos y actuar, dentro de nuestras competencias, para proteger al público", declaró Courtney Rhodes, vocera de la FDA.
"Muchos, la mayoría de los productos con THC se ajustan a la definición de marihuana, que es una sustancia controlada. La Drug Enforcement Administration (DEA) regula la marihuana en virtud de la Ley de Sustancias Controladas (CSA). Le remitimos a la DEA para preguntas sobre la regulación y aplicación de las disposiciones de la CSA", escribió Rhodes en un correo electrónico.
La DEA, dependiente del Departamento de Justicia, no respondió a las preguntas formuladas para este artículo.
En cuanto al Congreso, quizá su medida más importante haya sido limitar la aplicación de la prohibición federal.
"Hasta ahora, la respuesta federal a las acciones estatales para legalizar la marihuana ha consistido, sobre todo, en permitir que los estados apliquen sus propias leyes sobre la droga", señaló un informe de 2022 del Servicio de Investigación del Congreso.
En octubre, el presidente Joe Biden ordenó al secretario de Salud y Servicios Humanos y al fiscal general que revisaran la postura del gobierno federal respecto a la marihuana: si debería seguir clasificada entre las sustancias más peligrosas y estrictamente controladas.
En diciembre, Biden firmó un proyecto de ley que ampliaba la investigación sobre la marihuana y obligaba a las agencias federales a estudiar sus efectos. La ley dice que las agencias tienen un año para publicar sus conclusiones.
Algunos defensores de la marihuana dicen que el gobierno federal podría desempeñar un papel más constructivo.
"La NORML no opina que el cannabis sea inocuo, sino que la mejor forma de mitigar sus riesgos potenciales es mediante la legalización, la regulación y la educación pública", afirmó Paul Armentano, subdirector del grupo antes conocido como Organización Nacional para la Reforma de las Leyes sobre la Marihuana (NORML).
"Los productos tienen que someterse a pruebas de pureza y potencia", añadió, y "el gobierno federal podría ejercer cierta supervisión en la concesión de licencias a los laboratorios que prueban esos productos".
Mientras tanto, según Coleman, asesor de la Asociación Nacional de la Industria del Cannabis, los estados se quedan "teniendo que actuar como si fueran USDA + FDA + DEA, todo al mismo tiempo".
¿Y dónde deja eso a los consumidores? Algunos, como Wendy E., jubilada en sus 60 años, luchan contra los efectos de la marihuana.
Wendy, que habló con la condición de que no se revelara su nombre, empezó a fumar marihuana en la secundaria en los años 70 y la convirtió en su estilo de vida durante décadas.
Luego, cuando su estado la legalizó, la compró en dispensarios "y enseguida me di cuenta de que la potencia era mucho mayor que la que yo había consumido tradicionalmente", contó. "Parecía haber aumentado de manera exponencial".
En 2020, explicó, la marihuana legal —mucho más fuerte que la hierba ilícita de su juventud— la llevó a obsesionarse con el suicidio.
Antes, la mujer que se define como "hippie de la madre tierra" encontraba camaradería pasando un porro con sus amigos. Ahora asiste a reuniones de Marihuana Anónimos, con otras personas que se recuperan de esta adicción.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
USE OUR CONTENT
This story can be republished for free (details).
2 years 1 month ago
Health Industry, Mental Health, Noticias En Español, Colorado, Connecticut, FDA, Latinos, Legislation, marijuana, New Jersey, Substance Misuse, texas, Vermont
The Confusing Fate of the Abortion Pill
The Host
Julie Rovner
KFF Health News
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.
The abortion pill mifepristone is now ground zero in the abortion debate. Late Wednesday night, the 5th Circuit Court of Appeals said the drug should remain on the market but under restrictions on distribution that were in effect before 2016, which ban prescribing by mail or by telemedicine. The restrictions would make it even more difficult for patients in states where abortion is illegal or widely unavailable.
The decision comes in response to a ruling last week out of Texas, where a federal judge, as was widely expected, found that the FDA should not have approved the drug more than 22 years ago and ordered it, effectively, unapproved.
Complicating matters further still, in a separate case filed by 18 attorneys general in states where abortion is largely legal, last week a federal district judge in Washington state ordered the FDA not to reinstate any of the old restrictions.
This week’s panelists are Julie Rovner of KFF Health News, Victoria Knight of Axios, Shefali Luthra of The 19th, and Sarah Karlin-Smith of the Pink Sheet.
Panelists
Sarah Karlin-Smith
Pink Sheet
Victoria Knight
Axios
Shefali Luthra
The 19th
Among the takeaways from this week’s episode:
- A late-night decision by the appeals court preserves access to mifepristone while the legal battle continues. But it also resurrects outdated limitations on the drug, meaning mifepristone can be used only up to seven weeks into a pregnancy, among other restrictions.
- While it is expected that the U.S. Supreme Court will ultimately decide the drug’s fate, some providers and state officials are rushing to stockpile it. Cutting off access to the abortion pill puts extra pressure on clinics in states where abortion remains legal, which are also serving women from so-called prohibition states and could see an influx of patients as mifepristone becomes difficult — or impossible — to get.
- Republicans largely have remained quiet about the ruling overturning mifepristone’s FDA approval. While many in the party support banning the drug, they likely recognize the political risks of broadcasting that stance. Meanwhile, the Biden administration moved to strengthen privacy protections for patients and providers related to abortion, offering some reassurance to those who fear they could be prosecuted under their home state laws for seeking abortions elsewhere.
- As Southern states have whittled away at abortion access, Florida, with its 15-week abortion ban, had emerged as a hub for patients across the region. This week the state moved to restrict the procedure to six weeks, a change that could send many patients scrambling north to states like Virginia and New York for care. And in Idaho, a new law makes “abortion trafficking” — or transporting a minor to have an abortion without parental consent — a crime.
- Congress is exploring new drug pricing measures, particularly aimed at increasing transparency around pharmacy benefit managers and capping insulin costs. Lawmakers are also watching the approach of the debt ceiling threshold; in the mix of budgetary pressure valves are Medicaid and, potentially, work requirements to receive Supplemental Nutrition Assistance Program benefits.
- Congress continues to show little appetite for addressing a different, intensifying public health crisis: gun violence. A new poll from KFF shows startlingly high numbers of Americans — especially people of color — have directly experienced gun violence and live with that threat every day.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week they think you should read, too:
Julie Rovner: The Washington Post’s “To Comply With a New Sesame Allergy Law, Some Businesses Add — Sesame,” by Karen Weese.
Shefali Luthra: KFF Health News’ “For Uninsured People With Cancer, Securing Care Can Be Like Spinning a Roulette Wheel,” by Charlotte Huff.
Victoria Knight: The Washington Post’s “Research With Exotic Viruses Risks a Deadly Outbreak, Scientists Warn,” by David Willman and Joby Warrick.
Sarah Karlin-Smith: NBC News’ “Conspiracy Theorists Made Tiffany Dover Into an Anti-Vaccine Icon. She’s Finally Ready to Talk About It,” by Brandy Zadrozny.
Click to open the transcript
Transcript: The Confusing Fate of the Abortion Pill
KFF Health News’ ‘What the Health?’Episode Title: The Confusing Fate of the Abortion PillEpisode Number: 293Published: April 13, 2023
[Editor’s note: This transcript, generated using transcription software, has been edited for style and clarity.]
Julie Rovner: Hello and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent at KFF Health News. And I’m joined by some of the best and smartest health reporters in Washington. We are taping this week on Thursday, April 13, at 10 a.m. As always, news happens fast —really fast this week — and things might have changed by the time you hear this. So here we go. We are joined today by video conference by Victoria Knight of Axios.
Victoria Knight: Good morning.
Rovner: Sarah Karlin-Smith of the Pink Sheet.
Sarah Karlin-Smith: Hi, Julie.
Rovner: And Shefali Luthra of The 19th.
Shefali Luthra: Hello.
Rovner: Well, no interview this week, but spring is busting out all over with health news, so we will get right to it. We will begin in Texas with that court case that we’ve been saying for the last few weeks we hadn’t gotten a decision in. Well, we got a decision last Friday night around dinnertime and then very early this morning — that’s Thursday — we got an appeals court decision, too. But let’s take them one at a time. Last Friday night, in an opinion that was shocking but not surprising, as many people put it, Trump-appointed federal District Judge Matthew Kacsmaryk effectively rolled back the Food and Drug Administration’s 22-plus-year-old approval of mifepristone; that’s the first of two pills used for medication abortion early in pregnancy. Literally within the hour, federal District Judge Thomas Rice in Spokane, Washington, ruled in a separate case — brought by a group of about a dozen and a half state attorneys general — basically the opposite, ordering the FDA not to alter the current availability of the drug. Judge Kacsmaryk in Texas very kindly stayed his stay until this Friday to allow the Biden administration to appeal to the also very conservative 5th Circuit Court of Appeals. And in the wee hours of today, Thursday, an appeals court panel ruled that, while this lawsuit proceeds, mifepristone can continue to be sold, but only under the extremely onerous restrictions that were in effect until 2016. Shefali, where does that leave us? It’s kind of a mess, isn’t it?
Luthra: It is a huge mess, and the implications will be really significant. In particular, the 2016 restrictions on mifepristone don’t allow telemedicine. You have to go in person to a doctor to get the medication, and you can only use it up to seven weeks of pregnancy, when all of the evidence we have, including from the World Health Organization, says 10 weeks, sometimes maybe even 11. And I mean, we know realistically that people are taking mifepristone far later in pregnancy now because they can’t access legal abortion. And what this is going to do if it takes effect is it’s going to put a real strain on abortion clinics in states that have become destinations, right? The ones that are seeing so many out-of-state patients that largely do medication abortions because it’s easier, it’s faster, it pays a little bit better — all of these reasons that you do it —and that have really come to rely on telemedicine: Either they will have to take much longer to do this process and only do it for a handful of the patients they’re seeing, or they’ll switch to what we’ve talked about before, the misoprostol-only regimen, which is more painful, which is less effective. Still very good at terminating a pregnancy, but has a higher failure rate. And what clinics have told me is very often they expect that patients, when they hear that these are their options, will opt for a procedural abortion instead because that they know will absolutely work and they have to go home. They don’t worry about coming back to the clinic and worrying that they need an abortion again.
Karlin-Smith: I just want to put in the caveat that, you know, off-label use, which is where doctors prescribe a drug for use not approved for FDA, is something they do have sort of the discretion to do in practice of medicine once the product’s available. So the rollback is significant, but practically a lot of doctors will have the flexibility to still treat patients up to the longer timeframe. And people have pointed out this morning that, actually, many doctors were doing that prior to FDA formally expanding the approval.
Luthra: And to your point, many states have been stocking up on mifepristone in particular, and so have many abortion clinics, and they plan to use it as long as they can. The real challenge, I think, will be if there are supply issues at some point or other sorts of decisions from the Supreme Court, etc., or enforcement actions that essentially don’t allow telemedicine anymore.
Rovner: What it looks like the 5th Circuit has done is made it much harder for people in states where there are abortion bans to go to other states or to not go to another state but get the abortion pill, because they’ve banned it by mail; they’ve basically stopped in its tracks what we’ve been talking about for weeks — the ability of pharmacies to start to distribute it — because until 2016 you had to go — the doctor had to physically hand you the pill, which is what we are back to, and there have to be three visits in order to complete a medication abortion. These were all sort of the pre-2016 requirements. And the big question, though, is in Washington state, the requirement was that the FDA not change any of the relaxed restrictions. And now the 5th Circuit has said, yes, you will. So this still is on a fast track to the Supreme Court, right?
Luthra: It feels very like this is going to be decided by the Supreme Court. I mean, I wouldn’t be surprised if we hear about an appeal today. I wouldn’t be surprised if we hear about it tomorrow. It feels like really this could have changed between us taping and the podcast releasing.
Rovner: I think that’s entirely possible. So one of the things we thought Judge Kacsmaryk might do was order the FDA to basically restart its approval process for mifepristone, since his reasoning for rescinding essentially the drug’s approval is that the FDA violated its own procedures. Ironically, this decision came in a week when the FDA did withdraw the approval of a drug, a medication to prevent preterm birth called Makena. Sarah, what’s this drug and why is the FDA pulling it off the market? And this is how it’s supposed to work, right?
Karlin-Smith: Yes — supposed to work maybe is a stretch, depending on how some people felt about Makena; they felt it took way too long for FDA to withdraw it. So two sides of a coin, I suppose. But after a very long process, FDA finally pulled a drug that is given to women with the idea that it might help them deliver later, once their baby was full term, and prevent complications that come from having a premature birth. Unfortunately, over the years, as more clinical research was done on the drug, it appeared that it was not actually doing that. And as like all drugs, there are some side effects. And FDA basically ended up deciding, you know, absent any benefit, all you have is risk and this drug should not be pulled off the market. So it was finally pulled off the market after quite a lengthy process this week, right? It was still this week, or was it — no, it was last week.
Rovner: I think it was last week.
Karlin-Smith: Time. Time —
Rovner: Time is a very flat circle right now.
Karlin-Smith: Yeah, and so unfortunately it was really the only approved product that could possibly prevent preterm birth. And FDA really tried to recognize that and understand that people would be frustrated without options. But they tried to really emphasize the point that having an ineffective option is not the answer to that problem. The answer there is sort of push for more research on other products or even on this product to figure out if there’s a population of women it might benefit.
Rovner: So I wanted to mention that, because obviously the mifepristone ruling has the impact to affect much, much more than just abortion drugs. Individual drug companies are, to use the vernacular, freaking out about the idea that they could spend millions of dollars to shepherd a drug through clinical trials and the FDA approval process, only to see it banned because some small group of people object to it for some non-medical reason. Sarah, you cover the FDA. Is this freakout warranted right now?
Karlin-Smith: I do think most people think it is. And, you know, even in my preliminary look at what the 5th Circuit did this morning, I think that freakout is still going to continue because they seem to still give like this wide breadth that would allow many people to have the ability to challenge FDA approval decisions for any drug and then let judges weigh in who may not have the expertise and based on the science and all that other stuff that FDA has. So I think as this case has proceeded there’s still this underlying threat to the FDA’s authority and how they make decisions. Again, in the Texas case, he wasn’t trying to push it back to FDA and say, “OK, FDA, you go review this drug and decide again whether it needs to do it,” and then, you know, set them up for a Makena-like process where they would have to go through it. You know, they were trying to fast-track and overrule FDA’s authority. And if you read some of the details of the brief, you can really understand why it freaks out pharma and the FDA so much, because you can just tell how little the judge gets about how drugs are approved, the science, the regulatory process, and so forth.
Rovner: And basically that you have judges who are making medical and scientific decisions for which they are observably not qualified.
Karlin-Smith: Right, and I mean if nothing else industries likes stability, they like predictability, so there’s just this element of incredible unpredictability when you would have all these judges and potential legal cases throughout the country that would make it hard for them to deal with — and figuring out how to defend their products.
Rovner: So the FDA is obviously in an impossible situation here. They cannot satisfy both the Washington decision and the Court of Appeals decision because one says you can’t roll it back and one says you have to roll it back. Do we have any idea what the FDA is going to do here?
Luthra: I don’t know that we do. I mean, the Biden administration has said that they will follow the court orders, but the court orders are in conflict. So it seems like there should be some more clarity, perhaps, that we get. We, as of taping, haven’t gotten any statement from the president or the vice president or HHS, so we’ll keep an eye out and see if they have even just words of wisdom to offer about what this means or how they feel about the decision. But at this point, a lot is still quite confusing.
Rovner: So the Biden administration did take other action on abortion this week, in some separate steps. It announced Wednesday a series of new privacy protections for women and providers seeking or giving reproductive health care. How big a deal are these new rules, which sort of expand the HIPAA privacy rules? And why did it take them almost a year to do this? Hadn’t they been talking about this like right after the Dobbs ruling?
Luthra: They had been talking about this for a while. And what they said was that they believed that the guidance they had given to providers was sufficient to protect patient privacy. That has clearly not been the case, because we have continued to hear from people seeking abortions and from the health care providers giving them that they do not feel safe, right? They constantly have this fear that if I put something in someone’s medical record about an abortion, someone else might see it and it could get reported. So this should make that very clear beyond the guidance that was given out last summer — should make very clear that if you get an abortion, your doctor does not have to and should not tell any law enforcement about what happened. I think this has the potential to be really significant because one thing that we hear constantly from the people who are traveling out of state is they are terrified that they are breaking the law and that someone is going to find them, even though —
Rovner: That they’re breaking the law of their home state.
Luthra: Mm-hmm. Even though, of course, the home state laws do not criminalize the people who are seeking abortion.
Rovner: Yes. Well, I want to turn to the politics before we leave all of this. Democrats at all level of government were quick to decry this decision as wrong, anti-democratic, small d, and various other things. Republicans were a lot slower to react. How big a problem is abortion becoming for the Republican Party? They seem to be getting even more split on, “Gee, we thought that maybe overturning Roe was what we wanted and we were going to leave it at that.” And apparently anti-abortion activists are not leaving it at that.
Luthra: I mean, I think a great example of how Republicans are trying to navigate this problem is Congresswoman Nancy Mace, who, we may all recall, the day that Roe was overturned, put out a statement, like so many Republicans, saying that this was a great decision, very good for the country, the right step forward — and has since then tried very deliberately to walk away from that and to recalibrate her image on abortion and was one of the ones to come out this week and denounce the opinion from the District Court in Texas. Republicans who are willing to praise the decision in particular to take medication abortion off the market or to further restrict it, which is so unpopular, are finding themselves in a really tough spot. This is a winning issue for them and all they can really hope, and what we saw in the midterms, is to not talk about and to try and change the subject to something else.
Knight: I think important to note also that there were a good number of Republicans in Congress — think it was 69 — that signed on to an amicus brief both supporting the original lawsuit, this Texas lawsuit, and then also this decision when it came out.
Rovner: Right. This is an amicus brief to the Court of Appeals urging them to uphold the original decision.
Knight: Yeah. There were two amicus briefs , and a good number of congressional Republicans. — yeah, first for the original court case and then for the Appeals. But it was very noticeable that most of the Republican offices did not issue any kind of statement when this decision came out last week. So they’re fine supporting, putting documentation forward, supporting it, but they’re not broadcasting it, if that makes sense. And so I think that was very telling. It really was only Sen. Cindy Hyde-Smith, who is the Senate lead of the Pro-Life Caucus, that put something out. But it was very quiet among the rest of the Republicans, yeah.
Rovner: I noticed with that amicus brief, it’s like, OK, they’re going to say on the down-low to the anti-abortion activists, “We’re with you, but we really don’t want to publicize this because it’s not terribly popular with a lot of people.”
Luthra: To build on that, one example of someone who is really trying to walk that line and seems like is maybe facing challenges is Ron DeSantis, right? The person who did this compromise ban last year, the 15-week abortion ban, and now has clearly realized that if you want to be a nationally prominent Republican with support from the very powerful anti-abortion movement, you can’t do that; you need to be more overt in your disapproval of abortion and willingness to restrict access. But at the same time —
Rovner: Well, you’re anticipating my next question, which is that there is other abortion news this week. And in Florida, the legislature seems like it’s on the cusp of approving a six-week abortion ban to supplant the 15-week abortion ban it passed last year. And the aforementioned governor DeSantis says he will sign that if it comes to him. But Shefali, you’ve written about this. This could impact a lot more than just the people of Florida, right?
Luthra: I think it’s really important to note that Florida is the third-biggest state in the country and currently the biggest state in the eastern south part of the country where abortion is legal, even if it is only available up to 15 weeks. I have been to the clinics in Florida. It is stunning how crowded they are. There are people coming from all over the South. People are working until midnight to try and see every patient they can. And without Florida, the options are North Carolina and South Carolina. South Carolina clinics, there are very few of them, and they don’t go very far, not because of current state laws, but just because of the providers in the state. North Carolina is also looking likely to have some kind of abortion ban passed this year and again has way fewer clinics than Florida. If Florida is banning abortion after six weeks, a very, very large chunk of the country is going to be almost entirely displaced. The math just doesn’t really work. And we don’t know where people will be able to get abortions other than traveling, frankly, to Virginia, to D.C., to New York, and to all the places that so far, data shows, haven’t been as affected by out-of-state travelers.
Rovner: And of course, with the Court of Appeals decision basically saying that you can’t mail the abortion pills and that you can’t do it by telemedicine, I mean — which is not to say that people aren’t going to continue to get them by mail. It’s just that it won’t be FDA-sanctioned the way it was going to be. So Idaho is also making abortion news. This this feels like an afterthought, even though last week it seemed like a big deal. They have enacted a bill there creating the crime of abortion trafficking, which is the act of any adult transporting a minor for an abortion without her parent’s consent. Now, in the late 1990s and the early aughts, Republicans in the U.S. Congress tried unsuccessfully to pass something called the Child Custody Protection Act, which would have criminalized taking a minor across state lines for an abortion. But Idaho can’t do that. Only the federal government can regulate interstate travel. So this Idaho law just applies to the in-state portion of the trip. But it could still be a big deterrent, right? Unless you live right on the border. If you’re trying to take somebody out of state, you’re going to have to do part of it in state.
Luthra: I mean, of course. And I mean, Julie, I wanted to ask you about this because this is not actually a new kind of restriction. There are a bunch of states that have passed these, quote-unquote, “child trafficking laws” that restrict minors traveling out of state for abortion. Idaho is the first one to do it post-Dobbs. But for some reason, the anti-abortion movement has always had far more success in restricting access to minors. I think we’re all paying more attention now because we realize that this could in fact be the first step toward that thing that Justice Kavanaugh said would not happen, right? The larger-scale restriction of travel out of state for abortions.
Rovner: Yes. Restricting abortion for minors has been sort of the soft spot for the anti-abortion movement, really from the very beginning, because even people who consider themselves in favor of abortion rights, as we’ve seen this year with books — you know, parents are really like, “We want to be in charge of our daughters, and if my daughter needs my permission to get her ears pierced, she should need my permission to get an abortion or, God forbid, travel out of state or get contraception.” This is actually — it’s the minor issue that’s the reason that the Title X, the Family Planning Program, has not been reauthorized by Congress since 1984, which was before I started covering it. Oh, it’s my favorite piece of reproductive health trivia, because every time Congress tried to do it they got hung up over this question of should minors be able to get contraception without their parents’ approval. It is a continuing thing, but I think Idaho probably got more attention because they call this “abortion trafficking,” so we have a new law. All right. Well, there actually is other news this week that does not have to do with abortion. Congress next week will return from its two-week Easter/Passover break. And apparently at the top of the agenda in the Senate is a bill focusing on drug prices and particularly on pharmacy benefit managers. Even the Republican-led House is looking at PBM legislation. Sarah, remind us, what are PBMs and why are they so very unpopular among both Democrats and Republicans?
Karlin-Smith: So PBMs are companies contracted by your health insurance company or now, at this point, often owned by your health insurance company, that administer your pharmacy benefits, and they create the formularies that decide what drugs are covered and how much you are going to pay for them. And then they negotiate deals with pharmaceutical companies to try and lower the prices of drugs. And they also have to work with the pharmacies. So they’re called middlemen, often in a not very nice way. The drug industry has definitely tried to paint them as the key reason prices are too high, saying they give them discounts but they’re not passing them on to patients. It’s a bit more complicated than that. PBMs essentially say they do pass on that money to patients in the U.S. system but it ends up lowering everybody’s premiums, so not necessarily the person who’s paying for the high-cost drug. Of course, it’s a lot more complicated, because this is an industry, I think, surrounded by a lack of transparency. So it’s been hard for people, I think, to verify who’s getting that money and is it all really going to patients? And then, like I mentioned, this consolidation with health insurance companies, with parts of the pharmacy system as well, has started to raise a lot of kind of antitrust concerns and, again, that they may not be working in patients’ best interests.
Rovner: And a lot of this legislation is about transparency, right? It’s about sort of opening the black box of how PBMs set drug prices and negotiate with drug companies and pass these things along to insurers. I see you nodding, Victoria.
Knight: Yeah, and there’s a lot of different bills floating out there. There’s some that have passed out of committee in previous Congress that passed out of committee again, most notably a Senate Commerce bill — Chuck Grassley and Maria Cantwell — and that just passed out of committee, and that would implement some transparency measures, also ban the practice of spread pricing. There is some talk that Schumer may put a health package on the floor sometime soon, and so PBMs are going to potentially be a big part of that. There’s also supposed to be a markup sometime this month out of the Health, Education, Labor, Pensions Committee, where they also are talking about PBMs. So it’s interesting that there is a real movement on both sides of the aisle, also in the House, on PBMs. So they want to put some blame on high drug prices on someone. And right now it seems to be PBMs.
Rovner: And it looks like they’re going to go after insulin again, too, right? In the bill that passed last year they managed to cap insulin costs at $35 a month, but only for people on Medicare. So I guess this is the attempt to come back and require lower insulin prices for others. We will point out that many of the companies have voluntarily lowered some insulin prices, but looks like Congress not done with this yet, right?
Knight: No, it’s not done with it yet. Bernie Sanders is apparently going to haul some insulin execs in to have to testify, even though some of them have committed to lowering prices. And it’s also mentioned in the potential Schumer package, that $35 cap for everyone is supposed to be a part of it. And there’s also a lot of insulin $35-cap bills floating around. There is some Republican support in the Senate for that. There were some Republicans last year that voted for that. But I think the House will be the bigger issue, because there doesn’t seem to be as much Republican support in the House for a cap that extends to everyone.
Rovner: Yeah, but I mean, when we said sort of back in January that there might be some things that they could do on a bipartisan basis, it sounds like we’re starting to see some of them — now that it’s spring — blooming. So anything else that you are looking for this next session between, you know, Easter and Memorial Day?
Knight: I think also, I don’t know how much people are paying attention to this, but there is going to be one of those select subcommittee covid hearings next week and they’re bringing in some intelligence officials to talk about covid origins. So I think this is the first hearing with actual, like, intelligence officials. So I think it’ll be interesting to see what comes out of that. And obviously, there’s a lot of talk around, like, that practical policy implications are that Congress could kind of restrict NIH [National Institutes of Health] funding or how NIH gives out research funding because of all this talk around gain-of-function research in regards to covid origins. So I think that’s what we’re watching for rather than just the rhetoric around it, like what are the actual — how could it play out in regards to NIH funding? And then of course, can’t forget debt ceiling negotiations and work requirements are still very much being talked about.
Rovner: For Medicaid.
Knight: For Medicaid and also SNAP [Supplemental Nutrition Assistance Program] potentially. So there was reporting this morning from Punchbowl saying that work requirements are very much still in the proposals that are being kicked around. So, another thing to watch.
Rovner: May is traditionally a very busy month on Capitol Hill, particularly May of the odd-numbered year, the first year of a Congress, so I imagine we’ll see a lot. One last thing I want to talk about this week, and we haven’t talked about it for a while, but the toll of gun injuries just continues to mount. In the past three weeks, we’ve had mass shootings with multiple fatalities in Tennessee, Kentucky, and Florida. In Louisville, in fact, the mayor, who himself survived a mass shooting last year, lost a close friend in the shooting this week. So it’s not all that surprising that a new poll from my colleagues over the editorial firewall at KFF found that gun violence is so common that more than one in five Americans say they have personally been threatened by a gun. Nearly as many say a family member has been killed by a gun; 17% say they have personally witnessed someone being shot. The numbers are even worse for people of color. Nearly a third of Black adults have witnessed someone being shot, and more than a third have lost a family member to gun violence. We seem to have acknowledged finally that gun violence is a public health problem. Yet that hasn’t brought us any closer as a society to solving it. I mean, we were just talking about the things that Congress might be looking at in terms of health care in the spring. But gun violence isn’t really one of them, is it?
Knight: Yeah. I think you’ve seen from the Biden administration and acknowledgment from both sides of the aisle in Congress that the bipartisan bill that passed last year, which gave a lot of money towards mental health funding and also allowed states the option to implement red flag laws and some other smaller gun safety things. They kind of acknowledged that’s as far as they’re going to be able to go in the current makeup of this Congress. So it seems like a stalemate and it’s kind of like now on a state level. And there was some talk from Tennessee’s governor about doing some small things, perhaps after the shooting in Nashville, but it doesn’t seem like there is much movement.
Rovner: And of course, in Tennessee, it was fighting about not doing anything about guns that erupted in that whole conflagration with people getting —
Knight: — expelled —
Rovner: —evicted from the Tennessee state legislature and then reappointed and yeah, I mean, that — people may not remember, that’s actually over a gun demonstration or a lack-of-gun-legislation demonstration. So who knows whether anyone will find something to do about it. All right. That is the news for this week. Now it’s time for our extra credit segment. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it. We will post the links on the podcast page at khn.org and in our show notes on your phone or other mobile device. Sarah, why don’t you go first this week?
Karlin-Smith: Sure. I looked at an NBC News story called “Conspiracy Theorists Made Tiffany Dover Into an Anti-Vaccine Icon. She’s Finally Ready to Talk About It.” This was a nurse who was one of the first people to receive a covid vaccine when it first became available. And apparently, I guess, this is something that’s been a problem for her, she says, throughout her whole life. Sometimes with certain pain reactions she faints. And the story also talks about how she hadn’t really eaten lunch that day. But basically it was filmed and shared quite widely, including all over social media, and anti-vaccine activists basically took it and were using it sort of as proof of the harm caused by the vaccines. And the reaction to that from the hospital, and herself to some degree, was basically to just kind of keep quiet and not respond. There was very little pushback, yet — the idea was kind of if we ignore it, it will go away. But that just kept fueling everything. And basically people thought she might have even been dead and no one was telling. They thought the hospital was using her co-worker as sort of a body double to show proof of life. And a couple of years later, she’s finally trying to talk about what that experience was like and make clear again: She was fine, she was healthy, you know, she was more than happy to get the vaccine, you know, would do it again and stuff. But it’s a really interesting story because I think the journalists sort of go through again how we’ve been sort of grappling as a society with how to respond to this type of misinformation and how some of the normal kind of PR playbook strategies are actually hurting, not helping, public health. So we need to kind of shift to figure out how to handle that.
Rovner: And there are lots and lots and lots of these stories about people who, you know, quote-unquote, “died” when they got the vaccine, who are perfectly fine and walking around. It was — it was a really well done story. It’s just — it’s really kind of scary. Victoria.
Knight: Victoria, my extra credit this week is a story in The Washington Post by David Willman and Joby Warrick. It’s called “Research With Exotic Viruses Risks a Deadly Outbreak, Scientists Warn.” And so it’s basically kind of an in-depth look at how, over the years, the U.S. has funded virus research where — in other countries — where people go out into like forests and wildlife areas and collect bat samples, collect samples from different animals to try to kind of predict the next pandemic. And it profiles this one team in Thailand who has said, “We’re not accepting U.S. funds anymore.” They told the U.S. in 2021 after covid, “This feels too risky for us.” And we — they have been doing this research funded by the U.S. for four years, and they really felt like they hadn’t found much tangible benefit out of it either. So they’re kind of like, “It’s not worth the risk to our employees and potentially creating another pandemic on our own.”
Rovner: And and just to be clear, this isn’t gain-of-function research.
Knight: This is not even gain-of-function research.
Rovner: This is a different kind of potentially dangerous research.
Knight: Yeah, this is really just going out in the wild and collecting samples from animals that are out there already. But yeah, it’s not doing research in a lab that’s like altering a virus necessarily. So yeah, and so the story is kind of reckoning — like what is the balance between wanting to do scientific research and needing that knowledge for the future and the safety of employees and the general public. So, and it talked about how there is like — the U.S. does fund quite a bit of this kind of research around the world, and the pace of that has not always kept up with regulation and oversight. And so just kind of probing questions, especially as I talked about earlier — Congress does look into this issue of gain-of-function research and just the NIH funding research around the world in general.
Rovner: I feel like this whole week has been, where do government and science cross? Shefali.
Luthra: My story is from the well-named KFF Health News. It is called “For Uninsured People With Cancer, Securing Care Can Be Like Spinning A Roulette Wheel.” It’s by Charlotte Huff. It’s a really, really great look at what happens when you get cancer and in particular live in a state that didn’t expand Medicaid. Charlotte just does a really great job looking at the experiences that this woman has when she develops skin cancer and is recommended all these treatments that she can’t afford. She lives in South Carolina. She’s not eligible for Medicaid because they didn’t expand eligibility. And what it really gets into is the idea that there are a couple of cancers where you will get treatment, but for most of them, you will not get coverage; you have to pay thousands, sometimes tens of thousands out-of-pocket. And it’s a really well done, devastating look at what health care costs mean in our system and how much access really is for so much of health care based on where you happen to live.
Rovner: Yeah, it really is — really wonderful story. Well, my story, it’s also from The Washington Post, and it’s called “To Comply With a New Sesame Allergy Law, Some Businesses Add — Sesame,” by Karen Weese. So back in 2004, I covered the deliberation and passage of the Food Allergen Labeling and Consumer Protection Act, which for the first time required companies to put on the label in plain English if their products contained any of the eight major food allergens, which are milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. It was an enormous relief, particularly to parents of young children with allergies and to anyone with a food allergy that could be fatal. So, the law also required food companies to label whether there was a chance that the product could have been cross-contaminated with one of those allergens. That’s why you sometimes see on a label, you know, quote, “This product was produced in a facility that also makes milk products or that uses nuts” or some such thing. The law has worked pretty well, say those who fought for it, and in 2021 Congress added sesame to the list of allergens that had to be labeled. Except that this time something weird happened. Many food companies, rather than carefully cleaning and monitoring their plants to ensure there would be no cross-contamination with sesame, instead are basically evading the law’s intent by adding small amounts of sesame flour to their products and then putting on the label that “This product contains sesame.” It’s dangerous for a lot of reasons but mainly because for people with sesame allergies who have eaten certain products without problems for years, they may not realize that, to them at least, a poison has been added to their favorite bread or roll or whatever kind of product. So this is something that I imagine Congress is going to want to go back and take a look at. All right. Before we go this week, you may have noticed that the introduction to the podcast has been tweaked. That’s because we have a new name. Kaiser Health News has been retired as of this week. We are KFF Health News to reflect that we are an editorially independent program of KFF, also a new name, and that neither of us is connected in any way to that big HMO [health maintenance organization] Kaiser Permanente. I hope you will bear with us as we all get used to the change. OK, that is our show. As always, if you enjoyed 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. Special thanks, as always, to our ever-patient producer, Francis Ying. Also, as always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me, at least for the moment. I am still @jrovner. Victoria?
Knight: @victoriaregisk.
Rovner: Sarah?
Karlin-Smith: @SarahKarlin.
Rovner: Shefali.
Luthra: @shefalil.
Rovner: We will be back in your feed next week. Until then, be healthy.
Credits
Francis Ying
Audio producer
Emmarie Huetteman
Editor
To hear all our podcasts, click here.
And subscribe to KFF Health News’ ‘What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
USE OUR CONTENT
This story can be republished for free (details).
2 years 2 months ago
Courts, Multimedia, Pharmaceuticals, States, Abortion, diabetes, Drug Costs, FDA, Guns, KFF, KFF Health News' 'What The Health?', Podcasts, Polls, U.S. Congress
A Judicial Body Blow to the ACA
The Host
Julie Rovner
KHN
Julie Rovner is chief Washington correspondent and host of KHN’s 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.
Opponents of the Affordable Care Act may have stopped trying to overturn the entire law in court, but they have not stopped challenging pieces of it — and they have found an ally in Fort Worth, Texas: U.S. District Judge Reed O’Connor. In 2018, O’Connor held that the entire ACA was unconstitutional — a ruling eventually overturned by the Supreme Court. Now the judge has found that part of the law’s requirement for insurers to cover preventive care without copays violates a federal religious freedom law.
In a boost for the health law, though, North Carolina has become the 40th state to expand the Medicaid program to lower-income people who were previously ineligible. Even though the federal government will pay 90% of the cost of expansion, a broad swath of states — mostly in the South — have resisted widening eligibility for the program.
This week’s panelists are Julie Rovner of KHN, Alice Miranda Ollstein of Politico, Rachel Cohrs of Stat, and Sandhya Raman of CQ Roll Call.
Panelists
Rachel Cohrs
Stat News
Alice Miranda Ollstein
Politico
Sandhya Raman
CQ Roll Call
Among the takeaways from this week’s episode:
- Thursday’s decision out of Texas affects health plans nationwide and is expected to disrupt the health insurance market, which for years has provided preventive care without cost sharing under the ACA. Even if the decision survives a likely appeal, insurers could continue offering the popular, generally not-so-costly benefits, but they would no longer be required to do so.
- The decision, which found that the U.S. Preventive Services Task Force cannot mandate coverage requirements, hinges on religious freedom objections to plans covering PrEP, the HIV medication, alongside other preventive care.
- Speaking of the ACA, this week North Carolina became the latest state to expand Medicaid coverage under the health law, which will render an estimated 600,000 residents newly eligible for the program. The development comes amid reports about hospitals struggling to cover uncompensated care, particularly in the 10 states that have resisted expanding Medicaid.
- Pushback against Medicaid expansion has contributed over the years to a yawning coverage divide between politically “blue” and “red” states, with liberal-leaning states pushing to cover more services and people, while conservative-leaning states home in on policies that limit coverage, like work requirements.
- On the abortion front, state attorneys general are challenging the FDA’s authority on the abortion pill — not only in Texas, but also in Washington state, where Democratic state officials are fighting the FDA’s existing restrictions on prescribing and dispensing the drug. The Biden administration has adopted a similar argument as it has in the Texas case challenging the agency’s original approval of the abortion pill: Let the FDA do its job and impose restrictions it deems appropriate, the administration says.
- The FDA is poised to make a long-awaited decision on an over-the-counter birth control pill, an option already available in other countries. One key unknown, though, is whether the agency would impose age restrictions on access to it.
- And as of this week, 160 Defense Department promotions have stalled over one Republican senator’s objections to a Pentagon policy regarding federal payments to service members traveling to obtain abortions.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: New York Magazine/The Cut’s “Abortion Wins Elections: The Fight to Make Reproductive Rights the Centerpiece of the Democratic Party’s 2024 Agenda,” by Rebecca Traister.
Alice Miranda Ollstein: Stat’s “How the Drug Industry Uses Fear of Fentanyl to Extract More Profit From Naloxone,” by Lev Facher.
Rachel Cohrs: The Washington Post’s “These Women Survived Combat. Then They Had to Fight for Health Care,” by Hope Hodge Seck.
Sandhya Raman: Capital B’s “What the Covid-19 Pandemic and Mpox Outbreak Taught Us About Reducing Health Disparities,” by Margo Snipe and Kenya Hunter.
Also mentioned in this week’s podcast:
- The New York Times’ “‘We’re Going Away’: A State’s Choice to Forgo Medicaid Funds Is Killing Hospitals,” by Sharon LaFraniere.
- KHN’s “Fresh Produce Is an Increasingly Popular Prescription for Chronically Ill Patients,” by Carly Graf.
- California Healthline’s “Prescription for Housing? California Wants Medicaid to Cover 6 Months of Rent,” by Angela Hart.
click to open the transcript
Transcript: A Judicial Body Blow to the ACA
KHN’s ‘What the Health?’Episode Title: A Judicial Body Blow to the ACAEpisode Number: 291Published: March 30, 2023
[Editor’s note: This transcript, generated using transcription software, has been edited for style and clarity.]
Julie Rovner: Hello and welcome back to KHN’s “What the Health?” I’m Julie Rovner, chief Washington correspondent at Kaiser Health News. And I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, March 30, at 11 a.m. As always, news happens fast, and things might have 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: Good morning.
Rovner: Sandhya Raman of CQ Roll Call.
Sandhya Raman: Good morning.
Rovner: And happy birthday to you.
Raman: Thank you.
Rovner: And Rachel Cohrs of Stat News.
Rachel Cohrs: Hi, everybody.
Rovner: We’ve got breaking news, so we will get right to it. In Texas, we’ve got a major decision from a federal judge with national implications. No, not the abortion pill case — that is still out there. This time, Judge Reed O’Connor has ruled that the Affordable Care Act can’t require coverage of preventive services recommended by the [U.S.] Preventive Services Task Force because the PSTF, as an independent advisory board, can’t legally mandate anything. This case was specifically — although it was about a lot of things — but it was mostly about employers who didn’t want to cover preexposure prophylaxis [PrEP] for people at high risk of HIV because it violated their religious beliefs. And if the name Reed O’Connor sounds familiar, that’s because he’s the same judge who ruled in 2018 that the entire Affordable Care Act was unconstitutional, a finding that wasn’t formally overturned until it got to the Supreme Court. Alice, you’ve been following this case. What happens now?
Ollstein: I’m expecting the Biden administration to appeal at lightning speed, although that appeal will go to the 5th Circuit, which is very right-leaning. It’s ruled to chip away at the Affordable Care Act in the past. So who really knows what will happen there? But yeah, this is really huge. This is saying that this board that has decided what services insurance companies have to cover for free, with no cost sharing, going all the way back to 2010 is not constitutional, and thus what they say can’t be enforced. And so this throws the insurance market into a bit of chaos.
Rovner: Yeah, although one would think that it wouldn’t affect this year’s policies — I mean, for people who are going to be worried that all of a sudden, you know, oh my God, I scheduled my mammogram and now my insurer might not pay for it. It’s not going to be that immediate, right?
Ollstein: We’re not expecting that. I mean, we’re expecting the Biden administration to ask for courts to stay the impact of the ruling until further arguments and appeals can be made. But we really don’t know at this point. And I will say, you know, I’ve seen some misinformation out there about how the ruling deals with contraception. They do not block the contraception mandate. That is related to this case, but the court did not accept that part of the challengers’ claims.
Rovner: Yeah, we should say there are a bunch of different claims and the judge only accepted a couple of them. It could have been even broader. But, you know, unlike the previous Affordable Care Act cases, this one doesn’t threaten the entire law, but it does threaten one of the law’s most popular pieces, those requirements that plans cover preventive care that’s been shown to be cost-effective. This could be an uncomfortable case for the Supreme Court, assuming it gets there, couldn’t it?
Cohrs: It could be an uncomfortable case for the Supreme Court, but it’s also uncomfortable for insurers, too, who’ve promised this. People have come to expect it. And if it is cost-effective, I mean, certainly there may be plans that, you know, make choices to restrict coverage or impose some cost sharing. If this stands, if this is applied nationwide — again, very big ifs at this point — but if these really are cost-effective, then it’s kind of an open question what insurers will choose to do, because obviously they want people to enroll in their plans as well.
Rovner: Yeah, I was going to say, I could see insurers sort of deciding as a group that we’re going to keep providing this stuff, as you say, Rachel, because they want, you know, they want to attract customers, because for the most part it’s not that expensive. I mean, obviously, you know, things like colonoscopies can run into the thousands of dollars, but a lot of these things are, if not de minimis, then just not very expensive. And, as I mentioned, they’re very popular. So it’s possible that, even though they may strike down the mandate, there won’t be as much of an impact from this as some people are saying. But, as Alice points out, we don’t really know anything at this point.
Ollstein: And I think some of the concern is the kind of risk-pool sorting we used to see, you know. So the challengers said that their right to purchase insurance that doesn’t cover certain things was being infringed upon. And so if insurers start to create separate plans, some of which cover all kinds of preventive care, including sexual health care, and separate ones that don’t, and people who don’t think they need a lot of stuff, you know, sort themselves into some plans and not others, you can see that reflected in premiums that could lead to some of the major pre-ACA problems we used to see.
Rovner: If the idea that somebody doesn’t like something and therefore can’t buy something without it, you can see that leading to all kinds of problems down the line about people saying, well, “I don’t like that drugstores sell condoms, so therefore I should be able to go to a drugstore that doesn’t sell condoms,” although that’s not a mandate. But you can see that this could stretch very far with people’s religious beliefs. And indeed, the basis of this claim is that this violated the Religious Freedom Restoration Act. That’s one of the things that Judge O’Connor found, and that could be taken to quite the extreme, I imagine.
Ollstein: Right. I mean, they weren’t required to actually purchase PrEP. They weren’t required to use it. They weren’t required to prescribe it. Just the insurance company was required to cover it along with everything else they cover. And the folks said even purchasing insurance that had that as one of the things it could conceivably cover violated their religious rights.
Rovner: Yes. And this goes back to the contraceptive cases, where the religious organization said that, you know, by having birth control in their plans, it made them complicit in something that they thought was a sin. And that’s exactly what’s being stressed here, even among the individual plaintiffs: that having to buy insurance that has these benefits, even if they don’t use them, makes them complicit in, basically, sex outside of marriage. I mean, that’s what’s in the decision. It’s quite a reach. I’ll be interested to see, as this goes up, what people think of it. So, before we got Judge O’Connor’s opinion, what I thought would be the biggest news of the week comes from North Carolina, which on Monday became the 40th state to expand Medicaid under the Affordable Care Act, to cover people with incomes up to 138% of poverty. That’s about $20,000 in 2023. Well, it’s almost there. The newly eligible 600,000 people won’t be able to sign up until the legislature approves a budget, which is likely later this spring. North Carolina expanding the program leaves only a swath of states across the South, including Florida, Georgia, and Texas, and a couple in the Great Plains as still holding out on a 90% federal match. Is anyone else on the horizon or is this going to be it for a while?
Raman: I think one thing to note about how this is happening is that North Carolina was able to do this finally through the legislature after like a yearslong process. And it has been increasingly rare for this to happen through the legislature. The last time was Virginia, in 2018, but every other state that has done it in recent years has all been through ballot initiative and going that route. And the 10 holdouts that we have, you know, we have Republican-controlled legislatures who’ve been pretty against doing this. So I think if any of those states were to be able to do that at this point that haven’t been tempted by, you know, any of the incentives … [unintelligible] … get a higher match rate or anything like that, it would have to be through the ballot, which is already a difficult process, can take years. There have been various roadblocks to push back and even some of the states in the past that have been able to get it through ballot initiative — some of the legislatures afterwards have tried to like push back on it — when we saw with Utah a few years ago, where even if the voters had voted that they wanted to expand, they wanted to kind of pull it back.
Rovner: We thought in Maine, where the governor blocked it until basically he was out of office.
Raman: Yeah.
Ollstein: And in Missouri, where they just refused to fund it.
Raman: Yeah, so I think that’ll be definitely something to watch with how the budget goes in the next few months. But I guess, at least with North Carolina, this was something that was bipartisan. It was spearheaded in the legislature by Republicans, so I think they might not have the same issues there than Missouri, but it’s a tough haul to get the remaining 10 at this point after this many years.
Rovner: Yeah, I feel like North Carolina is much more like Virginia, which is that, finally, after a lot of wearing down, the Republican legislature and the Democratic governor were able to come to some kind of agreement. That’s what happened in Virginia. And that seems to be what’s happened here in North Carolina. Meanwhile, in those 10 states, hospitals which end up providing free care to people who can’t pay aren’t doing so well. In Florida, the state’s hospital association has been all but begging the state government to expand Medicaid pretty much since it was available to them, which is now going on 13 years. According to the American Hospital Association, 74% of rural hospital closures around the country took place in states that have not expanded Medicaid or where expansion had been in place for less than a year. And the New York Times has a story this week about the toll that that lack of insurance is taking — I’m sorry — and the New York Times has a story this week about the toll that lack of insurance for the working poor is taking there, not just on the state’s hospitals, but on the health of the state’s population. Lawmakers in these states are very happy to take federal money for all manner of things. What is it about this Medicaid expansion that’s making them say, “No, no, no”?
Raman: This was something that came up this week in the House. Appropriations’ Labor, HHS, Education Subcommittee had a hearing this week specifically on rural communities and some of the issues they face. And Medicaid expansion obviously did come up with some of the witnesses and some of the lawmakers as something that would be helpful given the number of hospital closures they’ve seen, and there might only be one health care facility for miles or in a county, and just how it would be helping them to kind of relieve paying for the uncompensated care that they’re already dealing with, you know, highlighted a number of the issues there. So it’s something that comes up, but I think one of the pushbacks that we saw was, you know, again, that it is a) tied to the Affordable Care Act, which has been such a partisan back-and-forth since its inception, and then b) just the messaging has always been about the cost. I mean, even if the general consensus is that it does save money over time for taking care of that care, something that came up was why states get more of a reimbursement for expansion than they do for traditional Medicaid. That was brought up a couple times, things like that. And so I think it’s hard to get some of those folks on board just because of how partisan it has become.
Rovner: Yeah, I remember I watched the hearing in Wyoming on this last year. They didn’t want to do it, it seemed, more for ideology. I mean, a lot of states that are doing this, you know, you can levy a tax on hospitals and nursing homes, who are happy to pay the tax because they’re now getting paid for these patients who couldn’t pay. And the state’s really not out-of-pocket, as it were, at all. But and yet, as we point out, these last 10 states, including some of the really big ones, have yet to actually succumb to this. Well, while we are talking about Medicaid, there have been a couple of interesting stories from my KHN colleagues in the past few weeks about so-called social determinants of health, those not strictly medical interventions that have a big impact on how sick or healthy people are. In California, Democratic Gov. Gavin Newsom wants to use Medicaid to pay for six months of rent or temporary housing for homeless people. And in Montana, health professionals can now prescribe vouchers for fruit and vegetables for patients with little access to fresh food. Is this the wave of the future, or will those who want to shrink rather than expand the welfare state and government in general roll programs like these back?
Cohrs: I think there certainly is a trend, a lot of momentum behind the idea of food as medicine and, you know, moving away and exploring some of these non-medication treatments or some of these underlying reasons why people do have health issues. I think certainly support for the Medicaid program is going to be a hot-button issue in D.C. over the next few months, but there is a lot that states can do on their own as well. And I know states have, you know, programs to kind of cover people that fall between the cracks of traditional insurance programs. California has a robust program for that, the local levels as well. So I think there may be ways to get around that, even if we do see some more restrictions. And again, the administration is Democratic at this point, so I think they may be friendlier to some of these innovations than prior ones, and that could change at any time. But this certainly isn’t something that’s going to go away.
Rovner: I wonder if we’re going to end up with blue states having all of these more robust pro — I mean, we already have blue states with more robust programs, but blue states having these more inclusive programs and red states not. Alice, you’re nodding.
Ollstein: Absolutely. And that’s been the trend for a while, but it could even accelerate now, I think, and you’re seeing that on both sides, with blue states looking to cover more and more things; also looking to cover more and more people, including undocumented people. That’s another trend in Medicaid. At the same time, you have red states that have long explored how to cover fewer and fewer, you know, trying to change the income eligibility threshold for expanded Medicaid, trying to do work requirements, trying to do, like, other restrictions. And so I think the patchwork and the divide is only going to continue.
Rovner: Well, moving on to abortion this week, we are still waiting, as I said, for that other decision out of Texas that could impact the future of the abortion pill mifepristone. But Alice, there’s another case at the other end of the country that could have something to say about the Texas case. What’s going on in Washington state?
Ollstein: This one has really flown under the radar. So this is an interesting situation where the same — a lot of the same Democratic attorneys general who were siding with the Biden administration in the Texas case are challenging the Biden administration in a different case in Washington state, basically saying that the remaining federal restrictions on abortion pills — mainly that providers have to get certified in order to prescribe the drugs or dispense them — saying that that should be tossed out, that it’s not supported by medicine and science. And so it’s interesting because you have the Biden administration fighting back against an effort to make the pills more accessible, which is not what a lot of people expect. It goes sort of against their rhetoric in recent months; they’ve talked about wanting to make the pills more accessible and they’re opposing an effort that would do that. But it is somewhat consistent with their position in the Texas case, which is, they’re saying, “Look, this is the FDA’s job. Let the FDA do its job. The FDA has a process, came up with these rules, got rid of some, kept others, and you outside folks don’t have the right to challenge and overturn it.”
Rovner: So what happens if the judges in both of these cases find for the plaintiffs, which would be kind of, but not completely, conflicting?
Ollstein: Yeah, so the Washington state case could just apply to the dozen states that are part of the challenge. And so you could have, again, more of a patchwork in which the abortion pills become even more accessible in those blue states and even less accessible in other states. You could also have these competing rulings that ultimately trigger Supreme Court review.
Rovner: Yeah, it’s not exactly a circuit split because it wouldn’t be opposite decisions on the same case; they’re different cases here. But as you point out, it’s really a case challenging the authority of the FDA to do what the FDA does. So it’s going to be really interesting to watch how this all plays out. While the future of mifepristone remains in doubt, the FDA is going to consider making at least one birth control pill over the counter. We know that morning-after pills, which are high doses of regular birth control pills, are already available without a prescription. So why hasn’t there been an over-the-counter birth control pill until now?
Ollstein: Everything concerning birth control, emergency contraception, abortion, it just — these fights drag on for years and years and years. So finally, we seem to be on the cusp of having a decision on this. It’s expected, from most people I’ve talked to, that they will approve this over-the-counter birth control. There’s a lot of data from around the world. A lot of other countries already have this. And one key unknown is whether the FDA will maintain an age restriction on it. A lot of progressive advocates do not want an age restriction because they think that this is important to help teens prevent unwanted pregnancies. And I think that’s going to be a big piece of the fight that I’m watching.
Rovner: And oh, my goodness, it was that age restriction that held up the over-the-counter morning-after pill for years. That was like a 13-year process to get that over the counter. It went on and on and on, and I covered it. All right. Well, there is abortion-related action on Capitol Hill too this week. We’ve got a potential abortion standoff brewing in the Senate over reproductive health policy at the Department of Defense. Who wants to talk about that one?
Raman: This one has been, I think, really interesting, since we’re all health reporters. And it’s been really something that I think my defense colleagues have been following so closely. But we have Senator Tuberville, who’s been holding up military nominations because the Pentagon has a policy that allows, you know, service members leave for reproductive care and it covers travel to seek an abortion. And so —
Rovner: Although it still doesn’t pay for the abortion.
Raman: It does not pay for the abortions. It’s for the travel. And so I know that my colleagues have looked at this and how this point, like, both sides have been getting a little frustrated, you know, with even some senators saying, “Hey, I agree that I don’t like this policy, but you need to find another way,” because as of earlier this week 160 promotions have been stalled. And so it’s just been kind of ramping up and holding up a lot of folks for kind of an unusual method.
Rovner: Yeah, and the defense secretary saying, I mean, this threatens national security because these are promotions — are important promotions. Flag officers, these are not, you know, just sort of — they’re routine, but they’re, you know, but if they don’t happen, if they get stalled, it’s a problem. In all of my years of seeing anti-abortion senators hold up things, this is not one I have seen before. It’s at least — it’s sort of new and imaginative, and I guess we will see how that plays out. Back in the states, though, it seems that the efforts to restrict reproductive rights are getting very extreme, very fast. Yes, the Oklahoma Supreme Court ruled earlier this month that a pregnant woman does have a right to an abortion when continuing the pregnancy threatens her life. But four of the nine justices there didn’t even want to go that far, suggesting that the legislature has the right to basically require saving the fetus even at the cost of the pregnant person’s life. In Texas, a lawsuit in which the ex-husband is suing the friend of his ex-wife for the wrongful death of his child for helping her get abortion medication is setting the stage for the so-called personhood debate: the idea that a new person with full legal right is created upon fertilization of an egg by sperm. Over the past few decades, several states have rejected personhood ballot measures as a bridge too far. But it feels like all bets are off now. I mean, it’s sort of like a race to see who can be the most extreme state.
Ollstein: I think the trends are revealing some interesting things. I mean, one, anti-abortion folks are well aware that people are still getting abortions, mainly in one of two ways: either traveling out of state or ordering pills online and taking them at home, both of which are very difficult to enforce and stop. And so there’s just a lot of, like, throwing spaghetti against the wall and seeing what sticks, in terms of, can we actually criminalize either of those things? If so, how is it enforced, or does it even need to be enforced? Or is just the fear and the chilling effect enough? I mean, we definitely see that. We definitely see medical providers holding off on doing even perfectly legal things because of fear and the chilling effect. And so there’s just a lot of experimentation at the state level right now.
Rovner: Yeah, I forgot to mention Idaho, where the legislature introduced a bill that would make it a crime — that creates abortion trafficking as a crime — for someone to take a minor, it’s not really across state lines, because the state can’t do that, so it’s like taking the minor to the border in an effort to cross state lines to get an abortion. There was, for many years in the late 1990s and early 2000s, something called the Child Custody Protection Act in Congress, because they needed that for the interstate part of it, that would make it a crime to take a minor across state lines in violation of the home state’s parental involvement laws. It passed both the House and the Senate at various times. It never became law. It’s been introduced recently, but nobody’s tried to take it up recently. I wouldn’t be surprised to see that come back up, too. But it really does seem that every day there’s another bill in another state legislature that says — after all the claims of the anti-abortion movement for decades, that we don’t want to punish the women, we only want to punish the providers — that’s gone out the window, right?
Raman: I guess I would add that, you know, we’re seeing a lot of this activity now. But something that I keep in mind is that a) it’s gotten a lot harder to know what’s going to, you know, using the spaghetti metaphor that Alice did, like what will stick. So there’s just a lot more flurry of action. And then I feel like I see increasingly, you know, people, since they don’t know that, just like fixating a lot on various things, just because you don’t know. I think, you know, even a few years ago, there were a lot of things that would have one sponsor or two sponsors and have no chance of going anywhere, as most bills introduced anywhere do. But now, a) a lot of these things are moving very, very quickly in the legislature, and b) since we don’t know, it’s hard to know where to kind of focus, even to some of the experts that I’ve talked to, where it’s just, “We’re not sure.” So just be aware of all of these things in various places because of kind of that uncertainty.
Rovner: Yeah, I know I’m generally loath to talk about bills that got introduced either in Congress or in state legislatures, because I think it unnecessarily creates expectations that for the most part don’t happen. But as both of you say, some of these things are happening so fast that, if you mention them one week, they’re law by the next week. So we will see as this continues to move quickly. All right. That’s the news for this week. Now it is time for our extra credit segment. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it. We will post the links on the podcast page at khn.org and in our show notes on your phone or other mobile device. Rachel, why don’t you go first this week?
Cohrs: All right. So my story is from the Washington Post, and the headline is “These Women Survived Combat. Then They Had to Fight for Health Care,” by Hope Hodge Seck. And I thought it was just a really great feature on this very niche issue. And I think veterans’ kind of health care overall just doesn’t get as much coverage as it should, and —
Rovner: Particularly women’s veteran’s health care.
Cohrs: Exactly. Yes. And so these women were essentially going into combat situations to help relations with women in very conservative cultures, and they were exposed to the grenade blasts and a lot of these combat situations. But then their health care coverage upon returning wasn’t covered. And there is kind of a new bill with some momentum behind it that is trying to plug that loophole. So, yeah, I thought it was a very great feature on an issue that’s undercovered.
Rovner: Yeah, this was something I knew nothing about until I read this story. Alice?
Ollstein: I chose a piece by Rachel’s colleague at Stat, Lev Facher, called “How the Drug Industry Uses Fear of Fentanyl to Extract More Profit From Naloxone.” And this is really timely, with the approval this week of over-the-counter opioid-overdose-reverse medication. And basically it’s about how these drug companies are coming up with new forms of the drug, really huge doses, new delivery forms, injectables, and nasal sprays, and stuff that are not really justified by science and are sort of just an opportunity for more profit because the basic form of the drug that works extremely well and is very affordable, they are basically hyping the fear of fentanyl to try to push these stronger products they’re coming up with. And the fear is that municipal governments that have limited resources are going to spend their money on those not really justified new forms and get fewer medication for everyone than just using the basic stuff that we know works.
Rovner: Indeed. Sandhya?
Raman: My extra credit is from Margo Snipe and Kenya Hunter at Capital B, and it’s called “What the Covid-19 Pandemic and Mpox Outbreak Taught Us About Reducing Health Disparities.” And I thought this was an interesting look that they did, highlighting how, you know, there’s been a lot more talk about the various health inequities among, you know, racial and ethnic and sexual minority communities after these two pandemics have started. And they look at how some of the targeted efforts have narrowed some of the gaps in things like vaccines, but just how some of these lessons can be used to address other health disparities, you know, things like community outreach and expanding types of screenings and how many languages public health information is translated into and things like that. So, it’s a good read.
Rovner: Well, my extra credit this week is a long read, a very long read, by Rebecca Traister in New York Magazine, called “Abortion Wins Elections: The Fight to Make Reproductive Rights the Centerpiece of the Democratic Party’s 2024 Agenda.” And while I’m not sure I’m buying everything that she’s selling here, this is an incredibly thorough and interesting look at the past, present, and possibly future of the abortion rights movement at the national, state, and local levels. If you are truly interested in this subject, it’s well worth the half hour or so of your time that it takes to get through the entire thing. It’s a really, really good piece. OK, that is our show for this week. As always, if you enjoyed 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. Special thanks, as always, to our ever-patient producer, Francis Ying. Also, as always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me still. I’m @jrovner. Alice?
Ollstein: @AliceOllstein.
Rovner: Rachel?
Cohrs: @rachelcohrs.
Rovner: Sandhya?
Raman: @SandhyaWrites.
Rovner: We will be back in your feed next week. Until then, be healthy.
Credits
Francis Ying
Audio producer
Emmarie Huetteman
Editor
To hear all our podcasts, click here.
And subscribe to KHN’s What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
USE OUR CONTENT
This story can be republished for free (details).
2 years 2 months ago
Health Care Costs, Insurance, Medicaid, Multimedia, Public Health, States, Abortion, Contraception, FDA, KHN's 'What The Health?', North Carolina, Obamacare Plans, Podcasts, texas, Women's Health
March Medicaid Madness
The Host
Julie Rovner
KHN
Julie Rovner is chief Washington correspondent and host of KHN’s 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.
With Medicare and Social Security apparently off the table for federal budget cuts, the focus has turned to Medicaid, the federal-state health program for those with low incomes. President Joe Biden has made it clear he wants to protect the program, along with the Affordable Care Act, but Republicans will likely propose cuts to both when they present a proposed budget in the next several weeks.
Meanwhile, confusion over abortion restrictions continues, particularly at the FDA. One lawsuit in Texas calls for a federal judge to temporarily halt distribution of the abortion pill mifepristone. A separate suit, though, asks a different federal judge to temporarily make the drug easier to get, by removing some of the FDA’s safety restrictions.
This week’s panelists are Julie Rovner of Kaiser Health News, Alice Miranda Ollstein of Politico, Rachel Cohrs of STAT News, and Lauren Weber of The Washington Post.
Panelists
Rachel Cohrs
Stat News
Alice Miranda Ollstein
Politico
Lauren Weber
The Washington Post
Among the takeaways from this week’s episode:
- States are working to review Medicaid eligibility for millions of people as pandemic-era coverage rules lapse at the end of March, amid fears that many Americans kicked off Medicaid who are eligible for free or near-free coverage under the ACA won’t know their options and will go uninsured.
- Biden promised this week to stop Republicans from “gutting” Medicaid and the ACA. But not all Republicans are on board with cuts to Medicaid. Between the party’s narrow majority in the House and the fact that Medicaid pays for nursing homes for many seniors, cutting the program is a politically dicey move.
- A national group that pushed the use of ivermectin to treat covid-19 is now hyping the drug as a treatment for flu and RSV — despite a lack of clinical evidence to support their claims that it is effective against any of those illnesses. Nonetheless, there is a movement of people, many of them doctors, who believe ivermectin works.
- In reproductive health news, a federal judge recently ruled that a Texas law cannot be used to prosecute groups that help women travel out of state to obtain abortions. And the abortion issue has highlighted the role of attorneys general around the country — politicizing a formerly nonpartisan state post. –And Eli Lilly announced plans to cut the price of some insulin products and cap out-of-pocket costs, though their reasons may not be completely altruistic: An expert pointed out that a change to Medicaid rebates next year means drugmakers soon will have to pay the government every time a patient fills a prescription for insulin, meaning Eli Lilly’s plan could save the company money.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: The New York Times’ “A Drug Company Exploited a Safety Requirement to Make Money,” by Rebecca Robbins.
Alice Miranda Ollstein: The New York Times’ “Alone and Exploited, Migrant Children Work Brutal Jobs Across the U.S.,” by Hannah Dreier.
Rachel Cohrs: STAT News’ “Nonprofit Hospitals Are Failing Americans. Their Boards May Be a Reason Why,” by Sanjay Kishore and Suhas Gondi.
Lauren Weber: KHN and CBS News’ “This Dental Device Was Sold to Fix Patients’ Jaws. Lawsuits Claim It Wrecked Their Teeth,” by Brett Kelman and Anna Werner.
Also mentioned in this week’s podcast:
- Politico’s “Why One State’s Plan to Unwind a Covid-Era Medicaid Rule Is Raising Red Flags,” by Megan Messerly.
- The Washington Post’s “Doctors Who Touted Ivermectin as Covid Fix Now Pushing It for Flu, RSV,” by Lauren Weber.
- NPR’s “To Safeguard Healthy Twins in Utero, She Had to ‘Escape’ Texas for Abortion Procedure,” by Selena Simmons-Duffin.
- The Daily Beast’s “Tennessee Abortion Ban a ‘Nightmare’ for Woman With Doomed Pregnancy,” by Michael Daly.
click to open the transcript
Transcript: March Medicaid Madness
KHN’s ‘What the Health?’Episode Title: Medicaid March MadnessEpisode Number: 287Published: March 2, 2023
Julie Rovner: Hello and welcome back to KHN’s “What the Health?” I’m Julie Rovner, chief Washington correspondent at Kaiser Health News. And I’m joined by some of the best and smartest health reporters in Washington. We are taping this week on Thursday, March 2, at 10 a.m. As always, news happens fast, and things might have changed by the time you hear this. So, here we go. We are joined today via video conference by Alice Miranda Ollstein of Politico.
Alice Miranda Ollstein: Good morning.
Rovner: Rachel Cohrs of Stat News.
Rachel Cohrs: Hi, everybody.
Rovner: And we officially welcome to the podcast panel this week Lauren Weber, ex of KHN and now at The Washington Post covering a cool new beat on health and science disinformation. Lauren, welcome back to the podcast.
Lauren Weber: Thanks for having me.
Rovner: So we’re going to get right to this week’s news. We’ve talked a lot about the political fight swirling around Medicare the past couple of weeks. So this week, I want to talk more about Medicaid. Our regular listeners will know, or should know, that states are beginning to re-determine eligibility for people who got on Medicaid during the covid pandemic and were allowed to stay on until now. In fact, Arkansas is vowing to re-determine eligibility for half a million people over the next six months. Alice, the last time Arkansas tried to do something bureaucratically complicated with Medicaid, it didn’t turn out so well, did it?
Ollstein: No. It was so much of a cautionary tale that no other state until now has gone down that path, although now at least a couple are attempting to. So Arkansas was the only state to actually move forward under the Trump administration with implementing Medicaid work requirements. And we covered it at the time, and just thousands and thousands of people lost coverage who should have qualified. They were working. They just couldn’t navigate the reporting system. Part of the problem was that you had to report your working hours online and a lot of people who are poor don’t have access to the internet. And, you know, the system was buggy and clunky and it was just a huge mess. But that is not stopping the state from trying again on several fronts. One, they want to do Medicaid work requirements again. The governor, Sarah Huckabee Sanders, has said that they plan to do that and also they plan to do their redeterminations for the end of the public health emergency in half the time the federal government would like states to take to do it. The federal government has incentives for states to go slow and take a full year to make sure people know how to prove whether or not they qualify for Medicaid and to learn what other insurance coverage options might be available to them. For instance, you know, Obamacare plans that are free or almost free.
Rovner: Yeah. Presumably most of the people who are no longer eligible for Medicaid but are still low-income will be eligible for Obamacare with hefty subsidies.
Ollstein: That’s right. So the fear is that history will repeat itself. A lot of people who should be covered will be dropped from coverage and won’t even know it because the state didn’t take the time to contact people and seek them out.
Rovner: This is something that we will certainly follow as it plays out over the next year. More broadly, though, there have been whispers — well, more than whispers, whines — over the past couple of weeks that President [Joe] Biden’s challenge to Republicans not to cut Social Security and Medicare, and Republicans’ apparent acceptance of that challenge, specifically leaves out Medicaid. Now, I never thought that was true, at least for the Democrats. But earlier this week, President Biden extended his promises to Medicaid and the Affordable Care Act. How much of a threat is there really to Medicaid in the coming budget battles? Rachel, you wrote about that today.
Cohrs: There is a lot of anxiety swirling around this on the Hill. I know there’s a former Trump White House official who’s circulated some documents that are making people a little bit nervous about Republicans’ position. But it is useful to look at existing documents out there. It is not reflective necessarily of the consensus Republican position. And it’s a very diverse party right now in the House. They have an incredibly narrow majority and Kevin McCarthy is really going to have to walk a tightrope here. And I think it is important to remember that when Medicaid has come up on steep ballot initiatives in red states, so many times it has passed overwhelmingly. So I think there is an argument to be made that Medicaid enjoys more political support among the GOP voting populace than maybe it does among members of Congress. So I think I am viewing it with caution. You know, obviously, it’s something that we’re going to have to be tracking and watching as these negotiations develop. But Democrats still hold the Senate and they still hold the presidency. So Republicans have more leverage than they did last Congress, but they’re still … Democrats still have a lot of sway here.
Rovner: Although I’ll just point out, as I think I pointed out before, that in 2017, when the Republicans tried to repeal the Affordable Care Act, one of the things they discovered is that Medicaid is actually kind of popular. I think … much to their surprise, they discovered that Medicaid is also kind of popular, maybe not as much as Medicare, but more than I think they thought. So I guess the budget wars really get started next week: We get President Biden’s budget, right?
Ollstein: And House Republicans are allegedly working on something. We don’t know when it will come or how much detail it will have, but it will be some sort of counter to Biden’s budget. But, you know, the real work will come later, in hashing it out in negotiations. And, really, a small number of people will be involved in that. And so just like Rachel said, you know, you’re going to see a lot of proposals thrown out over the next several months. Not all of them should necessarily be taken seriously or taken as determinative. Just one last interesting thing: This has been a really interesting education time, both for lawmakers and the public on just who is covered under these programs. I mean, the idea is that Medicare is so untouchable, is this third rail, because it is primarily seniors, and seniors vote. And seniors are more politically important to conservatives and Republicans. But people forget a lot of seniors are also on Medicaid. They get their nursing home coverage through there. And so I’ve heard a lot of Democratic lawmakers really hammering that argument lately and saying, look, you know, the stereotype for Medicaid is that it’s just poor adults, but …
Rovner: Yeah, moms and kids. That was how it started out.
Ollstein: Exactly.
Rovner: It was poor moms and kids.
Ollstein: Exactly. But it’s a lot more than that now. And it is more politically dicey to go after it than maybe people think.
Rovner: Yeah, I think Nancy Pelosi … in 2017 when, you know, if the threat with Medicare is throwing Granny off the cliff in her wheelchair, the threat of Medicaid is throwing Granny out of her nursing home, both of which have their political perils. All right. Well, we’ll definitely see this one play out for a while. I want to move to the public health beat. Lauren, you had a really cool story on the front page of The Washington Post this week about how the promise of ivermectin to treat infectious diseases in humans. And for those who forget, ivermectin is an anti-wormer drug that I give to my horse and both of my dogs. But the idea of using it for various infectious diseases just won’t die. What is the latest ivermectin craze?
Weber: Yes, and to be clear, there is an ivermectin that is a pill that can be given to humans, which is what these folks are talking about. But there’s this group called the Front Line COVID-19 Critical Care Alliance that really pushed ivermectin in the height of covid. As we all know on this podcast, scientific study after scientific study after clinical trial has disproved that there is any efficacy for that. But this group has continued to push it. And I discovered, looking at their website back this winter, that they’re now pushing it for the flu and RSV. And as I asked the CDC [Centers for Disease Control and Prevention] and medical experts, there’s no clinical data to support pushing that for the flu or RSV. And, you know, as one scientist said to me, they had data that … had antiviral properties in a test tube. But as one scientist said to me, well, if you put Coca-Cola in a test tube, it would show it had antiviral properties as well. So there’s a lot of pushback to these folks. But, that said, they told me that they have had their protocols downloaded over a million times. You know, they’re … absolutely have some prominence and have, you know, converted a share of the American population to the belief that this is a useful medical treatment for them. And one of the doctors that has left their group over their support of ivermectin said to me, “Look, I’m not surprised that they’re continuing to push this for something else. This is what they do now. They push this for other things.” And so it’s quite interesting to see this continue to play out as we continue into covid, to see them kind of expand, as these folks said to me, into other diseases.
Rovner: I know I mean, usually when we see these kinds of things, it’s because the people who are pushing them are also selling them and making money off of them. And I know that’s the case in some of this, but a lot of these are just doctors who are writing prescriptions for ivermectin. Right? I mean, this is an actual belief that they have.
Weber: Yeah, some of them do make money off of telehealth appointments. They can charge up to a couple hundred dollars for telehealth appointments. And one of the couple of co-founders had a lucrative Substack and book deal that talks about ivermectin and do get paid by this alliance. One of them made almost a quarter of a million dollars in salary from the alliance. But yeah, I mean, the average doctor that’s prescribing ivermectin, I mean — there were over 400,000 ivermectin prescriptions in, I think, it was August of 2021. So that’s a lot of prescriptions.
Rovner: They’re not all making money off of it.
Weber: They’re not all making money. And I mean, what’s wild to me is Merck has come out and said, which, in a very rare statement for a pharmaceutical company, you know, don’t prescribe our drug for this. And when I asked them about RSV and the flu, they said, yeah, our statement would still stand on that. So it’s a movement, to some extent. And the folks I talked to about it, they really believe …
Rovner: And I will say, for a while in 2021, you couldn’t get horse wormer, which is a very nasty-tasting paste, even the horses don’t really like it. Because it was hard to get ivermectin at all. So we’ll see where this goes next. Here’s one of those “in case you missed It” stories. The Tulsa World this week has an interview with former Republican Sen. James Inhofe, who said, in his blunt Inhofe way, that he retired last year not only because he’s 88, but because he’s still suffering the effects of long covid. And he’s not the only one — quote, “five or six others have [long covid], but I’m the only one who admits it,” he told the paper, referring to other members of the Senate, presumably other Republican members of the Senate. Now, mind you, the very conservative Inhofe voted against just about every covid funding bill. And my impression from not going to the Hill regularly in 2021 and 2022 is that while covid seemed to be floating around in the air, lots of people were getting it, very few people seemed to be getting very sick. But now we’re thinking that’s not really the case, right?
Ollstein: When I saw this, I immediately went back to a story I wrote about a year ago on Tim Kaine’s long covid diagnosis and his attempts to convince his colleagues to put more research funding or treatment funding, more basic covid prevention funding … you know, fewer people will get long covid if fewer people get covid in the first place. And there was just zero appetite on the Republican side for that. And that’s why a lot of it didn’t end up passing. Inhofe was one of the Republicans I talked to, and I said, you know, do you think you should do more about long covid? What do you think about this? And this is what he told me: “I have other priorities. We’re handling all we can right now.” And then he added that long covid is not that well defined. And he argued there’s no way to determine how many people are affected. Well.
Rovner: OK.
Ollstein: So that … in “Quotes That Aged Poorly Hall of Fame.”
Rovner: You know, obviously Tim Kaine came forward and talked about it. But now I’m wondering if there are people who are slowing down or looking like they’re not well, maybe they have long covid and don’t want to say.
Ollstein: Well, I mean, something that Tim Kaine’s case shows is that there’s no one thing it can look like and somebody can look completely healthy and normal on the outside and be suffering symptoms. And Tim Kaine has also said that members of Congress have quietly disclosed to him and thanked him for speaking up, but said they weren’t willing to do it themselves. And he, Tim Kaine, told me that he felt more comfortable speaking up because the kind of symptoms he had were less stigmatized. They weren’t anything in terms of impeding his mental capacity and function. And there’s just a lot of stigma and fear of people coming forward and admitting they’re having a problem.
Rovner: I find it kind of ironic that last week we talked about how, you know, members of Congress and politicians with mental health, you know, normally stigmatizing problems are more willing to talk about it. And yet here are people with long covid not willing to talk about it. So maybe we’ll see a little bit more after this or maybe not. I want to talk a little bit about artificial intelligence and health care. I’ve been wanting to talk about this for a while, but this week seems to be everyone is talking about AI. There have been a spate of stories about how different types of artificial intelligence are aiding in medical care, but also some cautionary tales, particularly about chat engines. They get all their information from the internet, good or bad. Now, we already have robots that do intricate surgeries and lots and lots of treatment algorithms. On the other hand, the little bit of AI that I already have that’s medical-oriented, my Fitbit, that sometimes accurately tracks my exercise and sometimes doesn’t, and the chat bot from my favorite chain drugstore that honestly cannot keep my medication straight. None of that makes me terribly optimistic about launching into health AI. Is this, like most tech, going to roll out a little before it’s ready and then we’ll work the bugs out? Or maybe are we going to be a little bit more careful with some of this stuff?
Cohrs: I think we’ve already seen some examples of things rolling out before they’re exactly ready. And I just thought of my colleague Casey Ross’ reporting on Epic’s algorithm that was supposed to help …
Rovner: Epic, the electronic medical records company.
Cohrs: Yes, yes. They had this algorithm that was supposed to help doctors treat sepsis patients, and it didn’t work. The problem with using AI in health care is that there are life-and-death consequences for some of these things. If you’re misdiagnosing someone, if you’re giving them medicine they don’t need, there are, like, those big consequences. But there are also the smaller ones too. And my colleague Brittany Trang wrote about how with doctor’s notes or transcripts of conversations between a physician and a patient sometimes AI has difficulty differentiating between an “mm-hm” or an “uh-huh” and telling whether that’s a yes or a no. And so I think that there’s just all of these really fascinating issues that we’re going to have to work through. And I think there is enormous potential, certainly, and I think there’s getting more experimentation. But like you said, I think in health care it’s just a very different beast when you’re rolling things out and making sure that they work.
Weber: Yeah, I wanted to add, I mean, one of the things that I found really interesting is that doctors’ offices are using some of it to reduce some of the administrative burden. As we all know, prior authorizations suck up a lot of time for doctors’ offices. And it seems like this has actually been really helpful for them. That said, I mean, that comes with the caveat of — my colleagues and I and much reporting has shown that — sometimes these things just make up references for studies. They just make it up. That level of “Is this just a made-up study that supports what I’m saying?” I think is really jarring. This isn’t quite like using Google. It cannot be trusted to the level … and I think people do have caution with it and they will have to continue to have caution with it. But I think we’re really only at the forefront of figuring out how this all plays out.
Rovner: I was talking before we started taping about how I got a text from my favorite chain drugstore saying that I was out of refills and that they would call my doctor, which is fine. And then they said, “Text ‘Yes’ if you would like us to call” … some other doctor. I’m like, “Who the heck is this other doctor?” And then I realize he’s the doctor I saw at urgent care last September when I burned myself. I’m like, “Why on earth would you even have him in your system?” So, you know, that’s the sort of thing … it’s like, we’re going to be really helpful and do something really stupid. I worry that Congress, in trying to regulate tech, and failing so far — I mean, we’ve seen how much they do and don’t know about, you know, Facebook and Instagram and the hand-wringing over TikTok because it’s owned by the Chinese — I can’t imagine any kind of serious, thoughtful regulation on this. We’re going to have to basically rely on the medical industry to decide how to roll this out, right? Or might somebody step in?
Ollstein: I mean, there could be agency, you know, rulemaking, potentially. But, yes, it’s the classic conundrum of technology evolving way faster than government can act to regulate it. I mean, we see that on so many fronts. I mean, look how long has gone without any kind of update. And, you know, the kinds of ways health information is shared are completely different from when that law was written, so …
Rovner: Indeed.
Weber: And as Rachel said, I mean, this is life-or-death consequences in some places. So the slowness with which the government regulates things could really have a problem here, because this is not something that is just little …
Rovner: Of the things that keep me awake at night, this is one of the things that keeps me awake at night. All right. Well, one of these weeks, we will not have a ton of reproductive health news. But this week isn’t it. As of this taping, we still have not gotten a decision in that Texas case challenging the FDA approval of the abortion pill, mifepristone, back in the year 2000. But there’s plenty of other abortion news happening in the Lone Star State. First, a federal judge in Texas who was not handpicked by the anti-abortion groups ruled that Texas officials cannot enforce the state’s abortion ban against groups who help women get abortion out of state, including abortion funds that help women get the money to go out of state to get an abortion. The judge also questioned whether the state’s pre-Roe ban is even in effect or has actually been repealed, although there are overlapping bans in the state that … so that wouldn’t make abortion legal. But still, this is a win for the abortion rights side, right, Alice?
Ollstein: Yeah, I think the right knows that there are two main ways that people are still getting abortions who live in ban states. They’re traveling out of state or they are ordering pills in the mail. And so they are moving to try to cut off both of those avenues. And, you know, running into some difficulty in doing so, both in the courts and just practically in terms of enforcing. This is part of that bigger battle to try to cut off, you know, people’s remaining avenues to access the procedure.
Rovner: Well, speaking exactly of that, Texas being Texas, this week, we saw a bill introduced in the state legislature that would ban the websites that include information about how to get abortion pills and would punish internet providers that fail to block those sites. It would also overturn the court ruling we just talked about by allowing criminal prosecution of anyone who helps someone get an abortion. Even a year ago, I would have said this is an obvious legislative overreach, but this is Texas. So now maybe not so much.
Ollstein: I mean, I think lots of states are just throwing things at the wall to see what sticks and to see what gets through the courts. You had states test the waters on banning certain kinds of out-of-state travel, and that hasn’t gone anywhere yet. But even things that don’t end up passing and being implemented can have a chilling effect. You have a lot of confusion right now. You have a lot of people not sure what’s legal, what’s not. And if you create this atmosphere of fear where people might be afraid to go out of state, might be afraid to ask for funding to go out of state, afraid to Google around and see what their options are that serves the intended impacts of these proposals, in terms of preventing people from exploring their options and seeing what they can do to terminate a pregnancy.
Rovner: Yeah. Well, meanwhile, a dozen states that are not named Texas are suing the FDA, trying to get it to roll back some of the prescribing requirements around the abortion pill. The states are arguing that not only are the risk-mitigation rules unnecessary, given the proven safety of mifepristone, but that some of the certification requirements could invade the privacy of patients and prescribers and subject them to harassment or worse. They’re asking the judge to halt enforcement of the restrictions while the case is being litigated. That could run right into [U.S. District] Judge [Matthew] Kacsmaryk’s possible injunction in Texas banning mifepristone nationwide. Then what happens? If you’ve got one judge saying, “OK, you can’t sell this nationwide,” and another judge saying … “Of course you can sell it, and you can’t use these safety restrictions that the FDA has put around it.” Then the FDA has two conflicting decisions in front of it.
Weber: Yeah, and I find the battles of the AGs and the abortion wars are really fascinating because, I mean, this is a lawsuit brought by states, which is attorneys general, Democratic attorneys general. And you’re seeing that play out. I mean, you see that in Texas, too, with [Ken] Paxton. You see it in Michigan with [Dana] Nessel. I mean, I would argue one of the things that attorney generals have been the most prominent on in the last several decades of American history and have actually had immediate effects on due to the fall of Roe v. Wade. So we’ll see what happens. But it is fascinating to see in real time this proxy battle, so to speak, between the two sides play out across the states and across the country.
Rovner: No, it’s funny. State AGs did do the tobacco settlement.
Weber: Yes.
Rovner: I mean, that would not have happened. But what was interesting about that is that it was very bipartisan.
Weber: Well, they were on the same side.
Rovner: And this is not.
Weber: Yeah, I mean, yeah, they were on the same side. This is a different deal. And I think to some extent, and I did some reporting on this last year, it speaks to the politicization of that office and what that office has become and how it’s become, frankly, a huge launching pad for people’s political careers. And the rhetoric there often is really notched up to the highest levels on both sides. So, you know, as we continue to see that play out, I think a lot of these folks will end up being folks you see on the national stage for quite some time.
Ollstein: I’ve been really interested in the states where the attorney general has clashed with other parts of their own state government. And so in North Carolina, for example, right now you have the current Democratic attorney general who is planning to run for governor. And he said, I’m not going to defend our state restrictions on abortion pills in court because I agree with the people challenging them. And then you have the Republican state legislatures saying, well, if he’s not going to defend these laws, we will. So that kind of clash has happened in Kentucky and other states where the attorney general is not always on the same side with other state officials.
Rovner: If that’s not confusing enough, we have a story out of Mississippi this week, one of the few states where voters technically have the ability to put a question on the ballot, except that process has been blocked for the moment by a technicality. Now, Republican legislators are proposing to restart the ballot initiative process. They would fix the technicality, but not for abortion questions. Reading from the AP story here, quote, “If the proposed new initiative process is adopted, state legislators would be the only people in Mississippi with the power to change abortion laws.” Really? I mean, it’s hard to conceive that they could say you can have a ballot question, but not on this.
Ollstein: This is, again, part of a national trend. There are several Republican-controlled states that are moving right now to attempt to limit the ability of people to put a measure on the ballot. And this, you know, comes as a direct result of last year. Six states had abortion-related referendums on their ballot. And in all six, the pro-abortion rights side won. Each one was a little different. We don’t need to get into it, but that’s the important thing. And so people voted pretty overwhelmingly, even in really red states like Kentucky and Montana. And so other states that fear that could happen there are now moving to make that process harder in different ways. You have Mississippi trying to do, like, a carve-out where nothing on abortion can make it through. Other states are just trying to raise, like, the signature threshold or the vote threshold people need to get these passed. There are a lot of different ways they’re going about it.
Rovner: I covered the Mississippi “personhood” amendment back in 2011. It was the first statewide vote on, you know, granting personhood to fetuses. And everybody assumed it was going to win, and it didn’t, even in Mississippi. So I think there’s reason for the legislators who are trying to re-stand up this ballot initiative process to worry about what might come up and how the voters might vote on it. Well, because I continue to hear people say that women trying to have babies are not being affected by state abortion bans and restrictions, this week we have not one but two stories of pregnant women who were very much impacted by abortion bans. One from NPR is the story of a Texas woman pregnant with twins — except one twin had genetic defects not only incompatible with life, but that threatened the life of both the other twin and the pregnant woman. She not only had to leave the state for a procedure to preserve her own life and that of the surviving twin, but doctors in Texas couldn’t even tell her explicitly what was going on for fear of being brought up on charges of violating the state’s ban. I think, Alice, you were the one talking about how, you know, women are afraid to Google. Doctors are afraid to say anything.
Ollstein: Yeah, absolutely. I mean, it’s a really chilling and litigious environment right now. And I think, as more and more of these stories start to come forward, I think that is spurring the debates you’re seeing in a lot of states right now about adding or clarifying or expanding the kind of exceptions that exist on these bans. So you have very heated debates going on right now in Utah and Tennessee and in several states around, you know, should we add more exceptions because there are some Republican lawmakers who are looking at these really tragic stories that are trickling out and saying, “This isn’t what we intended when we voted for this ban. Let’s go back and revisit.” Whether exceptions even work when they are on the books is another question that we can discuss. I mean, we have seen them not be effective in other states and people not able to navigate them.
Rovner: We’ve seen a lot of these stories about women whose water broke early and at what point is it threatening her life? How close to death does she have to be before doctors can step in? I mean, we’ve seen four or five of these. It’s not like they’re one-offs. The other story this week is from the Daily Beast. It’s about a 28-year-old Tennessee woman whose fetus had anomalies with its heart, brain, and kidneys. That woman also had to leave the state at her own expense to protect her own health. Is there a point where anti-abortion forces might realize they are actually deterring women who want babies from getting pregnant for fear of complications that they won’t be able to get treated?
Ollstein: Most of the pushback I’ve seen from anti-abortion groups, they claim that the state laws are fine and that doctors are misinterpreting them. And there is a semantic tug of war going on right now where anti-abortion groups are trying to argue that intervening in a medical emergency shouldn’t even count as an abortion. Doctors argue, no, it is an abortion. It’s the same procedure medically, and thus we are afraid to do it under the current law. And the anti-abortion groups are saying, “Oh, no, you’re saying that in bad faith; that doesn’t count as an abortion. An abortion is when it’s intended to kill the fetus.” So you’re having this challenging tug of war, and it’s not really clear what states are going to do. There’s a lot of state bills on this making their way through legislatures right now.
Rovner: And doctors and patients are caught in the middle. Well, finally this week, Eli Lilly announced it would lower, in some cases dramatically, the list prices for some of its insulin products. You may remember that, last year, Democrats in Congress passed a $35-per-month cap for Medicare beneficiaries but couldn’t get those last few votes to apply the cap to the rest of the population. Lilly is getting very good press. Its stock price went up, even though it’s not really capping all the out-of-pocket costs for insulin for everybody. But I’m guessing they’re not doing this out of the goodness of their drugmaking heart, right, Rachel?
Cohrs: Probably not. Even though there’s a quote from their CEO that implied that that was the case. I think there was one drug pricing expert at West Health Policy Center, Sean Dickson, who is very sharp on these issues, knows the programs well. And he pointed out that there’s a new policy going into effect in Medicaid next year, and it’s really, really wonky and complicated. But I’ll do my best to try to explain that, generally, in the Medicare program, rebates are capped, or they have been historically, at the price of the drug. So you can’t charge a drugmaker a rebate that’s higher than the cost. But …
Rovner: That would make sense.
Cohrs: Right. But that math can get kind of wonky when there are really high drug price increases and then that math gets really messed up. But Congress, I want to say it was in 2021, tweaked this policy to discourage those big price increases. And they said, you know what? We’re going to raise the rebate cap in Medicaid, which means that, drugmakers, if you are taking really big price increases, you may have to pay us every time someone on Medicaid fills those prescriptions. And I think people thought about insulin right away as a drug that has these really high rebates already and could be a candidate disproportionately impacted by this policy. So I thought that was an interesting point that Sean made about the timing of this. That change is supposed to go into effect early next year. So this could, in theory, save Lilly a lot of money in the Medicaid program because we don’t know exactly what their net prices were before.
Rovner: But this is very convenient.
Cohrs: It’s convenient. And there’s a chance that they’re not really losing any money right now, depending on how their contracts work with insurers. So I think, yeah, there is definitely a possibility for some ulterior motives here.
Rovner: And plus, the thing that I learned this week that I hadn’t known before is that there are starting to be some generic competition. The three big insulin makers, which are Lilly, Sanofi, and Novo Nordisk, may actually not become the, almost, the only insulin maker. So it’s probably in Lilly’s interest to step forward now. And, you know, they’re reducing the prices on their most popular insulins, but not necessarily their most expensive insulin. So I think there’s still money to be made in this segment. But they sure did get, you know, I watched all the stories come across. It’s, like, it’s all, oh, look at this great thing that Lilly has done and that everything’s going to be cheap. And it’s, like, not quite. But …
Cohrs: But it is different. It’s a big step. And I think …
Rovner: It is. It is.
Cohrs: Somebody has to go first in breaking this cycle. And I think it will be interesting to see how that plays out for them and whether the other two companies do follow suit. Sen. Bernie Sanders asked them to and said, you know, why don’t you just all do the same thing and lower prices on more products? So, yeah, we’ll see how it plays out.
Weber: Day to day, I mean, that’s a huge difference for people. I mean, that is a lot of money. That is a big deal. So, I mean, you know, no matter what the motivation, at the end of the day, I think the American public will be much happier with having to pay a lot less for insulin.
Rovner: Yeah, I’m just saying that not everybody who takes insulin is going to pay a lot less for insulin.
Weber: Right. Which is very fair, very fair.
Rovner: But many more people than before, which is, I think, why it got lauded by everybody. Although I will … I wrote in my notes, please, someone mention Josh Hawley taking credit and calling for legislation. Sen. Hawley from Missouri, who voted against extending the $35 cap, as all Republicans did, to the rest of the population, put out a tweet yesterday that was, like, this is a great thing and now we should have, you know, legislation to follow up. And I’m like: OK.
Cohrs: You’ll have to check on that. I actually think Hawley may have voted for it.
Rovner: Oh, a-ha. All right.
Cohrs: There were a few Republicans.
Rovner: Thank you.
Cohrs: It’s not enough, though.
Rovner: Yeah, I remember that they couldn’t get those last few votes. Yes, I think [Sen. Joe] Manchin voted against. He was the one, the last Democrat they couldn’t get right. That’s why they ended up dropping …
Cohrs: Uh, it had to be a 60-vote threshold, so …
Rovner: Oh, that’s right.
Cohrs: Yeah.
Rovner: All right. Good. Thank you. Good point, Rachel. All right. Well, that is the news for this week. Now it is time for our extra-credit segment. That’s when we each recommend a story we read this week we think you should read, too. As always, don’t worry if you miss it. We will post the links on the podcast page at khn.org and in our show notes on your phone or other mobile device. Alice, why don’t you go first this week?
Ollstein: Yeah. So I did the incredible New York Times investigation by Hannah Dreier on child labor. This is about undocumented, unaccompanied migrant children who are coming to the U.S. And the reason I’m bringing it up on our podcast is there is a health angle. So HHS [the Department of Health and Human Services], their Office of Refugee Resettlement has jurisdiction over these kids’ welfare and making sure they are safe. And that is not happening right now. The system is so overwhelmed that they have been cutting corners in how they vet the sponsors that they release the kids to. Of course, we remember that there were tons of problems with these kids being detained and kept for way too long and that being a huge threat to their physical and mental health. But this is sort of the pendulum has swung too far in the opposite direction, and they’re being released to people who in some cases straight up trafficking them and in other cases just forcing them to work and drop out of school, even if it’s not a trafficking situation. And so this reporting has already had an impact. The HHS has announced all these new initiatives to try to stop this. So we’ll see if they are effective. But really moving, incredible reporting.
Rovner: Yeah, it was an incredible story. Lauren.
Weber: I’m going to shout out my former KHN colleague Brett Kelman. I loved his piece on, I guess you can’t call it a medical device because it wasn’t approved by the FDA, which is the point of the story. But this device that was supposed to fix your jaw so you didn’t have to have expensive jaw surgery. Well, what it ended up doing is it messed up all these people’s teeth and totally destroyed their mouths and left them with a bunch more medical and dental bills. And, you know, what I find interesting about the story, what I find interesting about the trend in general is the problem is, they never applied for anything with the FDA. So people were using this device, but they didn’t check, they didn’t know. And I think that speaks to the American public’s perception that devices and medical devices and things like this are safe to use. But a lot of times the FDA regulations are outdated or are not on top of this or the agency is so understaffed and not investigating that things like this slipped through the cracks. And then you have people — and it’s 10,000 patients, I believe, that have used this tool — that did not do what it is supposed to do and, in fact, injured them along the way. And I think that the FDA piece of that is really interesting. It’s something I’ve run into before looking at air cleaners and how they fit the gaps of that. And I think it’s something we’re going to continue to see as we examine how these agencies are really stacking up to the evolution of technology today.
Rovner: Yeah, capitalism is going to push everything. Rachel.
Cohrs: So my extra credit this week is actually an opinion piece, in Stat, and the headline is “Nonprofit Hospitals Are Failing Americans. Their Boards May Be a Reason Why.” It was written by Sanjay Kishore and Suhas Gondi. I think the part that really stood out to me is they analyzed the backgrounds and makeups of hospital boards, especially nonprofit hospitals. I think they analyzed like 20 large facilities. And the statistic that really surprised me was that, I think, 44% of those board members came from the financial sector representing investment funds, real estate, and other entities. Less than 15% were health care workers, 13% were physicians, and less than 1% were nurses. And, you know, I’ve spent a lot of time and we’ve spent a lot of time thinking about just how nonprofit hospitals are operating as businesses. And I think a lot of other publications have done great work as well making that point. But I think this is just a stark statistic that shows these boards that are supposed to be holding these organizations accountable are thinking about the bottom line, because that’s what the financial services sector is all about, and that there’s so much disproportionately less clinical representation. So obviously hospitals need admin sides to run, and they are businesses, and a lot of them don’t have very large margins. But the statistics just really surprised me as to the balance there.
Rovner: Yeah, I felt like this is one, you know, we’ve all been sort of enmeshed in this, you know, what are we going to do about the nonprofit hospitals that are not actually acting as charitable institutions? But I think the boards had been something that I had not seen anybody else look at until now. So it’s a really interesting piece. All right. Well, my story this week is the other big investigation from The New York Times. It’s called “A Drug Company Exploited a Safety Requirement to Make Money,” by Rebecca Robbins. And it’s about those same risk-mitigation rules from the FDA that are at the heart of those abortion drug lawsuits we talked about a few minutes ago. Except in this case, the drug company in question, Jazz Pharmaceuticals, somehow patented its risk-mitigation strategy as the distribution center — it’s actually called the REMS [Risk Evaluation and Mitigation Strategies] — which is managed to fend off generic competition for the company’s narcolepsy drug. It had also had a response already. It has produced a bipartisan bill in the Senate to close the loophole — but [I’ll] never underestimate the creativity of drugmakers when it comes to protecting their profit. It’s quite a story. OK. That’s our show for this week. As always, 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. Special thanks, as always, to our ever-patient producer, Francis Ying. Also, as always, you can email us your comments or questions. We’re at whatthehealth — all one word — at kff.org. Or you can tweet me. I’m @jrovner. Alice?
Ollstein: @AliceOllstein
Rovner: Rachel.
Cohrs: @rachelcohrs
Rovner: Lauren.
Weber: @LaurenWeberHP
Rovner: We will be back in your feed next week. In the meantime, be healthy.
Credits
Francis Ying
Audio producer
Emmarie Huetteman
Editor
To hear all our podcasts, click here.
And subscribe to KHN’s What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
USE OUR CONTENT
This story can be republished for free (details).
2 years 3 months ago
COVID-19, Health Care Costs, Health Industry, Insurance, Medicaid, Medicare, Multimedia, Abortion, Biden Administration, Drug Costs, FDA, KHN's 'What The Health?', Obamacare Plans, Podcasts, Prescription Drugs, texas, Women's Health