Food and Drug Administration (FDA) has approved RYBREVANT (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test.

 This FDA action converts the May 2021 accelerated approval of RYBREVANT to a full approval based on the confirmatory Phase 3 PAPILLON study.

“When aiming for the best possible treatment outcomes, a targeted approach should be used in the first line for patients with EGFR exon 20 insertion mutations, as this is a commonly applied practice for patients with NSCLC harboring other molecular driver alterations,” said Joshua K. Sabari, M.D., an oncologist at NYU Langone’s Perlmutter Cancer Center and study investigator. “The results observed in the PAPILLON study showed significant improvement in progression-free survival, supporting the use of this regimen as the potential standard-of-care in the first-line treatment of these patients.”

Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases. Alterations in EGFR are the most common actionable driver mutations in NSCLC. Clinical data show patients with EGFR exon 20 insertion mutations generally experience limited benefits with currently approved third-generation EGFR tyrosine kinase inhibitors and chemotherapy. NSCLC driven by EGFR exon 20 insertion mutations carries a worse prognosis and shorter survival rates compared with lung cancer driven by other EGFR driver mutations.

“For patients with lung cancer and their families, each breakthrough in treatment provides not only a new option, but a potential lifeline. The approval of RYBREVANT plus chemotherapy heralds a promising new first-line treatment option for patients newly diagnosed with non-small cell lung cancer where their driver mutation is an EGFR exon 20 insertion,” said Marcia Horn, Executive Director of the Exon 20 Group and CEO of ICAN, International Cancer Advocacy Network. “This new regimen is a major advance over chemotherapy alone. We’ve seen first-hand the extended survival that Exon 20 Group patients experienced on RYBREVANT plus chemotherapy in the PAPILLON study, and we’re delighted that this historic treatment option, which specifically targets the EGFR exon 20 insertion mutation, has been approved.”

The FDA approval is based on positive results from the randomized, open-label Phase 3 PAPILLON study, which showed RYBREVANT plus chemotherapy resulted in a 61 percent reduction in the risk of disease progression or death compared to chemotherapy alone. Results also showed treatment with RYBREVANT plus chemotherapy improved objective response rate (ORR) and progression-free survival (PFS). Based on PAPILLON data, the National Comprehensive Cancer Network (NCCN) updated its’ NCCN Clinical Practice Guidelines (NCCN Guidelines) to include a category 1 recommendation for amivantamab-vmjw (RYBREVANT) plus chemotherapy as a preferred first-line therapy for patients with NSCLC with EGFR exon 20 insertion mutations.8 †‡

“We are redefining care for patients with non-small cell lung cancer by advancing innovative regimens that can be used early, with the goal of extending survival,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Johnson & Johnson Innovative Medicine. “RYBREVANT plus chemotherapy is the first targeted approach approved for the first-line treatment of patients with NSCLC with EGFR exon 20 insertion mutations. We look forward to building on this latest milestone as we continue to accelerate our transformative lung cancer portfolio.”

Warnings and Precautions include Infusion Related Reactions (IRR), Interstitial Lung Disease (ILD)/Pneumonitis, Dermatologic Adverse Reactions, Ocular Toxicity and Embryo-fetal Toxicity. The most common adverse reactions (≥20 percent) were rash, nail toxicity, stomatitis, IRR, fatigue, edema, constipation, decreased appetite, nausea, COVID-19, diarrhea and vomiting. The most common Grade 3 or 4 laboratory abnormalities (≥2 percent) were decreased albumin, increased alanine aminotransferase, increased gamma-glutamyl transferase, decreased sodium, decreased potassium, decreased magnesium, and decreases in white blood cells, hemoglobin, neutrophils, platelets, and lymphocytes.

Read also: JnJ gets USFDA nod for Bi-weekly dose of blood cancer therapy Tecvayli

In findings from a substudy of the TRAVERSE trial published in JAMA Internal Medicine, researchers found testosterone therapy did not result in differences in glycemic outcomes compared with placebo.“The

The Host

Julie Rovner
KFF Health News

@jrovner

Read Julie's stories.

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.

Reverberations from the Alabama Supreme Court’s first-in-the-nation ruling that embryos are legally children continued this week, both in the states and in Washington. As Alabama lawmakers scrambled to find a way to protect in vitro fertilization services without directly denying the “personhood” of embryos, lawmakers in Florida postponed a vote on the state’s own “personhood” law. And in Washington, Republicans worked to find a way to satisfy two factions of their base: those who support IVF and those who believe embryos deserve full legal rights.

Meanwhile, Congress may finally be nearing a funding deal for the fiscal year that began Oct. 1. And while a few bipartisan health bills may catch a ride on the overall spending bill, several other priorities, including an overhaul of the pharmacy benefit manager industry, failed to make the cut.

This week’s panelists are Julie Rovner of KFF Health News, Rachel Cohrs of Stat, Riley Griffin of Bloomberg News, and Joanne Kenen of Johns Hopkins University’s schools of nursing and public health and Politico Magazine.

Panelists

Rachel Cohrs
Stat News

@rachelcohrs

Read Rachel's stories.

Riley Griffin
Bloomberg

@rileyraygriffin

Read Riley's stories.

Joanne Kenen
Johns Hopkins Bloomberg School of Public Health and Politico

@JoanneKenen

Read Joanne's articles.

Among the takeaways from this week’s episode:

• Lawmakers are readying short-term deals to keep the government funded and running for at least a few more weeks, though some health priorities like preparing for a future pandemic and keeping down prescription drug prices may not make the cut.
• After the Alabama Supreme Court’s decision that frozen embryos are people, Republicans find themselves divided over the future of IVF. The emotionally charged debate over the procedure — which many conservatives, including former Vice President Mike Pence, believe should remain available — is causing turmoil for the party. And Democrats will no doubt keep reminding voters about it, highlighting the repercussions of the conservative push into reproductive health care.
• A significant number of physicians in Idaho are leaving the state or the field of reproductive care entirely because of its strict abortion ban. With many hospitals struggling with the cost of labor and delivery services, the ban is only making it harder for women in some areas to get care before, during, and after childbirth — whether they need abortion care or not.
• A major cyberattack targeting the personal information of patients enrolled in a health plan owned by UnitedHealth Group is drawing attention to the heightened risks of consolidation in health care. Meanwhile, the Justice Department is separately investigating UnitedHealth for possible antitrust violations.
• “This Week in Health misinformation”: Panelist Joanne Kenen explains how efforts to prevent wrong information about a new vaccine for RSV have been less than successful.

Also this week, Rovner interviews Greer Donley, an associate professor at the University of Pittsburgh School of Law, about how a 150-year-old anti-vice law that’s still on the books could be used to ban abortion nationwide.

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

Julie Rovner: ProPublica’s “Their States Banned Abortion. Doctors Now Say They Can’t Give Women Potential Lifesaving Care,” by Kavitha Surana.

Rachel Cohrs: The New York Times’ “$1 Billion Donation Will Provide Free Tuition at a Bronx Medical School,” by Joseph Goldstein.

Joanne Kenen: Axios’ “An Unexpected Finding Suggests Full Moons May Actually Be Tough on Hospitals,” by Tina Reed.

Riley Griffin: Bloomberg News’ “US Seeks to Limit China’s Access to Americans’ Personal Data,” by Riley Griffin and Mackenzie Hawkins.

Also mentioned on this week’s podcast:

• The Washington Post’s “Florida Lawmakers Postpone ‘Fetal Personhood’ Bill After Alabama IVF Ruling,” by Lori Rozsa.
• Stat’s “Congress Punts on PBM Reform Efforts,” by Rachel Cohrs and John Wilkerson.
• Politico Magazine’s “There’s a New Life-Saving Vaccine. Why Won’t People Take It?” by Joanne Kenen.
• Stat’s “Experts Say Scale of Change Cyberattack Shows Risks of Centralized Claims Processing,” by Brittany Trang, Tara Bannow, and Bob Herman.
• The Wall Street Journal’s “U.S. Opens UnitedHealth Antitrust Probe,” by Anna Wilde Mathews and Dave Michaels.
• CNN’s “Opinion: It’s Too Dangerous to Allow This Antiquated Law to Exist Any Longer,” by David S. Cohen, Greer Donley, and Rachel Rebouché.

click to open the transcript

Transcript: Alabama’s IVF Ruling Still Making Waves

KFF Health News’ ‘What the Health?’Episode Title: Alabama’s IVF Ruling Still Making WavesEpisode Number: 336Published: Feb. 29, 2024

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

Julie Rovner: Hello, and welcome back to “What the Health?” I’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, Feb. 29, at 10 a.m. Happy leap day, everyone. As always, news happens fast and things might’ve changed by the time you hear this, so here we go.

We are joined today via video conference by Rachel Cohrs of Stat News.

Rachel Cohrs: Hi, everybody.

Rovner: Riley Ray Griffin of Bloomberg News.

Riley Griffin: Hello, hello.

Rovner: And Joanne Kenen of the Johns Hopkins University schools of nursing and public health and Politico Magazine.

Joanne Kenen: Hi, everybody.

Rovner: Later in this episode we’ll have my interview with University of Pittsburgh law professor Greer Donley about that 150-year-old Comstock Act we’ve talked about so much lately. But first, this week’s news.

So as we tape this morning, the latest in a series of short-term spending bills for the fiscal year that began almost five months ago, is a day and a half away from expiring, and the short-term bill for the rest of the government is 15 days from expiring. And apparently the House and Senate are in the process of preparing yet another pair of short-term bills to keep the government open for another week each, making the new deadlines March 8 and March 22. I should point out that the Food and Drug Administration is included in the first set of spending bills that would expire, and the rest of HHS [Department of Health and Human Services] is in the second batch.

So what are the chances that this time Congress can finish up the spending bills for fiscal 2024? Rachel, I call this Groundhog Day, except February’s about to be over.

Cohrs: Yeah, it’s definitely looking better. I think this is the CR [continuing resolution] where, as I’m thinking about it, the adults are in the room and the negotiations are actually happening. Because we had a couple of fake-outs there, where nobody was really taking it seriously, but I think we are finally at a place where they do have some agreement on some spending bills. The House hopefully will be passing some of them, and I’m optimistic that they’ll get it at least close within that March 8-March 22 time frame to extend us out a few more months until we get to do this all over again in September.

At least right now, which it could change, they do have a couple of weeks, but it’s looking like the main kind of health care provisions that we were looking at are going to be more of an end-of-year conversation than happening this spring.

Rovner: Which is anticipating my next question, which is a bunch of smaller bipartisan bills that were expected to catch a ride on the spending bill train seemed to have been jettisoned because lawmakers couldn’t reach agreement. Although it does look like a handful will make it to the president’s desk in this next round, and its last round, of fiscal spending bills for fiscal 2024.

Let’s start with the bills that are expected to be included when we finally get to these spending bills, presumably in March.

Cohrs: So, from my reporting, it sounds like that there’s going to be an extension of funding for the really truly urgent programs that are expiring. We’re talking community health center funding, funding for some public health programs. It’s funding for safety-net hospitals through Medicaid. Those policies might be extended. There’s a chance that there could be some bump in Medicare payments for doctors. I haven’t seen a final number on that yet, but that’s at least in the conversation for this round.

Again, there’s going to be more cuts at the end of this year. So, I think we’ll be continuing to have this conversation, but those look like they’re in for now. Again, we don’t have final numbers, but that’s kind of what we’re expecting the package to look like.

Kenen: And the opioids is under what you described as public health, right, or is that still up in the air?

Cohrs: I think we’re talking SUPPORT Act; I think that is up in the air, from my understanding. With public health programs talking, like, special diabetes reauthorization — there are a couple more small-ball things, but I think SUPPORT Act, PAHPA [Pandemic and All Hazards Preparedness Act], to my understanding, are still up in the air. We’ll just have to wait for text. That hopefully comes soon.

Rovner: Riley, I see you nodding too. Is that what you’re hearing?

Griffin: Yeah. Questions about PAHPA, the authorizations for pandemic and emergency response activities, have been front of mind for folks for months and months, particularly given the timing, right? We are seeing this expire at a time when we’ve left the biggest health crisis of our generation, and seeing that punted further down the road I think will come as a big disappointment to the world of pandemic preparedness and biodefense, but perhaps not altogether unexpected.

Rovner: So Rachel, I know there were some sort of bigger things that clearly got left on the cutting room floor, like legislation to do something about pharmacy benefit managers and site-neutral payments in Medicare. Those are, at least for the moment, shelved, right?

Cohrs: Yes. That’s from my understanding. Again, I will say now they bought themselves a couple more weeks, so who knows? Sometimes a near-death experience is what it takes to get people moving in this town. But the most recent information I have is that site-neutral payments for administering drugs in physicians’ offices, that has been shelved until the end of the year and then also reforms to how PBMs [pharmacy benefit managers] operate. There’s just a lot of different policies floating around and a lot of different committees and they just didn’t come to the table and hash it out in time. And I think leadership just lost patience with them.

They do see that there’s another bite at the apple at the end of the year. We do have a lot of members retiring, Cathy McMorris Rodgers on the House side, maybe [Sen.] Bernie Sanders. He has not announced he’s running for reelection yet. So I think that’s something to keep in mind for the end of the year. And there also is a big telehealth reauthorization coming up, so I think they view that as a wildly popular policy that’s going to be really expensive and it’s going to be another … give them some more time to just hash out these differences.

Kenen: I would also point out that this annual fight about Medicare doctor payments was something that was supposedly permanently fixed. Julie and I spent, and many other reporters, spent countless hours staking out hallways in Congress about this obscure thing that was called SGR, the sustainable growth rate, but everyone called it the “doc fix.” It was this fight every year that went on and on and on about Medicare rates and then they replaced it and it was supposed to be, “We will never have to deal with this again.”

I decided I would never write another story about it after the best headline I ever wrote, which was, “What’s up, doc fix?” But here we are again. Every single year, there’s a fight about …

Rovner: Although this isn’t the SGR, it’s just …

Kenen: They got rid of SGR, that era was over. But what we’ve learned is that era will probably never be over. Every single year, there will be a lobbying blitz and a fight about Medicare Advantage and about Medicare physician pay. It’s like leap year, but it happens every year instead of every four.

Rovner: Because lobbyists need to get paid too.

All right, well, I want to turn to abortion where the fallout continues from that Alabama Supreme Court ruling earlier this month that found frozen embryos are legally children. Republicans, in particular, are caught in an almost impossible position between portions of their base who genuinely believe that a fertilized egg is a unique new person deserving of full legal rights and protections, and those who oppose abortion but believe that discarding unused embryos as part of the in vitro fertilization process is a morally acceptable way for couples to have babies.

In Alabama, where the ruling has not just stopped IVF clinics from operating in the state, but has also made it impossible for those in the midst of an IVF cycle to take their embryos elsewhere because the companies that would transport them are also worried about liability, the Republican-dominated legislature is scrambling to find a way to allow IVF to resume in the state without directly contradicting the court’s ruling that “personhood” starts at fertilization.

This seems to be quite a tightrope. I mean, Riley, I see you nodding. Can they actually do this? Is there a solution on the table yet?

Griffin: No, I don’t think there’s a solution on the table yet, and there are eight clinics in Alabama that do this work, according to the CDC [Centers for Disease Control and Prevention]. Three of them have paused IVF treatment across the board. We’ve been in touch with these clinics as days go by as we see some of these developments, and they’re not changing their policies yet. Some of these efforts by Republicans to assure that there won’t be criminal penalties, they’re not reassuring them enough.

So, it certainly is a tightrope for providers and patients. It’s also a tightrope, as you mentioned, Julie, for the Republican Party, which is divided on this matter, and for Republican voters, who are also divided on this matter. But ultimately, this whole conversation comes back to what constitutes a human being? What constitutes a person? And the strategy of giving rights to an embryo allows abortion laws to be even more restrictive across this country.

Rovner: Yeah, I can’t tell you how many stories I’ve written about “When does life begin?” over the last 30 years, because that’s really what this comes down to. Does life begin at fertilization? Does it begin … I mean, doctors, I have learned this over the years, that conception is actually not fertilization. Conception is when basically a fertilized egg implants in a woman’s uterus. That’s when pregnancy begins. So there’s this continuing religious and scientific and ethical and kind of a quagmire that now is front and center again.

Joanne, you wanted to add something?

Kenen: No. I mean, I thought [Sen.] Lindsey Graham had one of the best quotes I’ve seen, which is, “Nobody’s ever been born in a freezer.” So this is a theological question that is turning into a political question. And even the proposed legislation in Alabama, which would give the clinics immunity or a pardon, I mean, pardon means you committed a crime. In this case, a murder, but you were pardoned for it. I mean, I don’t think that’s necessarily … and it’s only good for this was a stopgap that would, if it passes, I believe it would be just till early 2025.

So it might get these clinics open for a while. They may come up with some way of getting families that are in the middle of fertility treatments to be able to complete it, but other states could actually go the way Alabama went. We have no guarantee. There are people pushing for that in some of the more conservative states, so this may spread. The attempt in Congress, in the Senate, to bring up a bill that would address it …

Rovner: We’ll get to that in a second.

Kenen: I mean, Alabama’s a conservative state, but the governor, who was a conservative anti-abortion governor, has said she wants to reopen the clinics and protect them, but they haven’t come up with the formula to do that yet.

Rovner: So speaking of other states, when this decision came down in Alabama, Florida was preparing to pass its own personhood bill, but now that vote has been delayed at the request of the bill’s sponsor. The, I think, initial reaction to the Alabama decision was that it would spur similar action in other states, as you were just saying, Joanne, but is it possible that the opposite will happen, that it will stop action in other states because those who are pushing it are going to see that there’s a huge divide here?

Griffin: That hesitation certainly signals that that’s a possibility. The pause in pushing forward that path in Florida is a real signal that there is going to be more debate within the Republican Party.

One thing I do want to mention is a lot of focus has been on whether clinics in Alabama or otherwise would stop IVF treatment altogether. But I think equally important is how the clinics that are continuing to offer IVF treatment, what changes they’re making. The ones that we’re seeing, are speaking with in Alabama that are continuing to offer IVF, are changing their consent forms. They are fertilizing fewer eggs, they’re freezing eggs, but they’re not fertilizing them because they don’t want to have excess wastage, in their perspective, that could lead them to a place of liability.

So all these things ultimately have ramifications for patients. That is more costly. It means a longer timeline. It also means fewer shots on goal. It means that it is potentially harder for you to get pregnant, at the end of the day. So I want to center the fact that clinics that are continuing to offer IVF are facing real changes here too.

Rovner: We know from Texas that when states try to indemnify, saying, “Well, we won’t prosecute you,” that that’s really not good enough because doctors don’t want to run the chance of ending up in court, having to hire lawyers. I mean, even if they’re unlikely to be convicted and have their licenses taken away, just being charged is hard enough. And I think that’s what’s happening with doctors with some of these abortion exceptions, and that’s what’s happening with these IVF clinics in places where there’s personhood.

Sorry, Joanne. Go ahead.

Kenen: Egg-freezing technology has gotten better than it was just a few years ago, but egg-freezing technology, to the best of my knowledge, egg-freezing technology, though improved, is nowhere near as good as freezing an embryo. Particularly now they can bring embryos out to what they call the blastocyst stage. It’s about five days. They have a better chance of successful implantation.

In addition to the expense of IVF, and it’s expensive and most people don’t have insurance cover[age] for it, it means you’re going through drugs and treatment and all of us have had friends, I think, who’ve gone through it or relatives. It is just an incredibly stressful, emotionally painful process.

Rovner: Well, you’re pumping yourself full of hormones to create more eggs, so yeah.

Kenen: And you’re also trying to get pregnant. If you’re spending $20,000 a cycle or whatever it is, and pumping yourself full of hormones, doing all this, it means that having a child is of utmost importance to you.

And the emotional trauma of this, if you listen to the … we’ve heard interviews in the last few days of women who were about to have a transfer and things like that, the heartbreak is intense, and fertility is not like catching a cold. It’s really stressful and sad, and this is just causing anguish to families trying to have a child, trying to have a first child, trying to have a second child, whatever, or trying to have a child because there’s a health issue and they want to do the pre-implantation genetic testing so that they don’t have another child die. I mean, it’s really complicated and terrible costs on all kinds of costs, physical, emotional, and financial.

Rovner: Yeah, there are lots of layers to this.

Well, meanwhile, this decision has begun to have repercussions here on Capitol Hill. In the Senate, the Democrats are, again, while it’s in the news, trying to force Republicans into taking a stand on this issue by bringing up a bill that would guarantee nationwide access to IVF. This is a bill that they tried to bring up before and was blocked by Republicans. On Wednesday, a half a dozen senators led by Illinois’ Tammy Duckworth, a veteran who used IVF to have her two children, chided Republicans on the floor who failed again to let them bring up the IVF bill. This time, as last time, it was blocked by Republican Sen. Cindy Hyde-Smith of Mississippi.

I imagine the Democrats aren’t going to let this go anytime soon though. They certainly indicated that this is not their last attempt at this.

Kenen: No. Why should they? If anyone thought that the politics of abortion were going to subside by November, this has just given it … I don’t even have a word for how much it’s been reinvigorated. This is going to stick in people’s minds, and Republicans are divided on IVF, but there’s no path forward. Democrats are going to be trying again and again, if they can, and they’re going to remind voters of it again and again.

Rovner: And in the Republican House, they’re scrambling to figure out again, as in Alabama, how to demonstrate support for IVF without running afoul of their voters who are fetal personhood supporters.

Just to underline how delicate this all is, the personhood supporting anti-abortion group, Susan B. Anthony [Pro-Life America], put out a statement this week, not just thrashing the Democrats’ bill, which one would expect, but also the work going on by Republicans in Alabama and in the U.S. House for not going far enough. They point out that Louisiana has a law that allows for IVF, but not for the destruction of leftover embryos. Although that means, as Riley was saying before, those embryos have to be stored out of state, which adds to the already high cost of IVF.

It is really hard to imagine how Republicans at both the state and federal level are going to find their way out of this thicket.

Kenen: It’s a reproductive pretzel.

Griffin: It’s a reproductive pretzel where two-thirds of Americans say frozen embryos shouldn’t be considered people. So I mean, there is data to suggest that this isn’t a winning selling point for the Republican Party, and we saw that play out with presidential candidate Donald Trump immediately distancing himself from the Alabama Supreme Court decision. So, what a pretzel it is.

It’s going to be interesting to see how this pans out as the logistical hurdles continue to arise. And some are basic. I mean, I spoke last week with one clinic in Alabama that said that they had had dozens, I think they said 30 to 40, embryos that had been abandoned over decades going back as 2008, and they had tried to reach people by phone, by mail, by email. They had just been left behind. What do you do in that situation? They had been prepared to dispose of those embryos and now they’re sitting on shelves. Is that the answer? Is the only answer to have shelves and shelves of frozen embryos?

Rovner: Yeah, I mean, it is. It is definitely a pretzel.

Kenen: There was a move at one point to allow them to be adopted. I think …

Rovner: It’s still there. It’s still there.

Kenen: Right, but I don’t know what kind of consent you need. I mean, if the situations where someone left the frozen embryo and doesn’t respond or their email, they’ve changed their email or whatever, there may be some kind of way out for this mess that involves the possibility of adopting them at some point down the road, and they may not be biologically viable by that point. But when I was thinking of what are the political outs, what is the exit ramp, I haven’t heard any politicians talk about this yet, but that occurred to me as something that might end up figuring into this.

And the other thing, just to the point as to how deeply divided, I think many listeners know this, but for the handful who don’t, the illustration of how deeply divided even very anti-abortion Republicans are, is [former Vice President] Mike Pence, his family was created through IVF, and he’s clearly, he’s come out this week. I mean, there’s no question that Mike Pence is anti-abortion, there’s not a lot of doubt about that, but he has come forth and endorsed IVF as a life-affirming rather, as a good thing.

Rovner: And I actually went and checked when this all broke because Joanne probably remembers in the mid-2000s when they were talking about stem cell research that President George W. Bush had a big event with what were called “snowflake children,” which were children who were born because they were adopted leftover embryos that someone else basically gestated, and that …

Kenen: But I don’t think they’ll call them “snowflake” anymore.

Rovner: Yeah. Well, that adoption agency is still around and still working and still accepting leftover embryos to be adopted out. That does still exist. I imagine that’s probably of use in Louisiana too, where you’re not allowed to destroy leftover embryos.

Well, meanwhile, we have some new numbers on something else we’ve been talking about since Dobbs [v. Jackson Women’s Health Organization]. Doctors who deliver babies in states with abortion bans are choosing to leave rather than to risk arrest or fines for providing what they consider evidence-based care. In Idaho, according to a new report, 22% of practicing obstetricians stopped practicing or left the state from August 2022 to November 2023. And, at the same time, two hospitals’ obstetric programs in the state closed, while two others report having trouble recruiting enough doctors to keep their doors open.

I would think this is going to particularly impact more sparsely populated states like Idaho, which also, coincidentally or not, are the states that tend to have the strictest abortion bans. I mean, it’s going to be … this seems to be another case where it’s going to be harder, where abortion bans are going to make it harder to have babies.

Cohrs: Yeah. I mean, we’re already seeing a trend of hospital systems being reluctant to keep OB-GYN delivery units open anyway. We’ve seen care deserts. It’s really not a profitable endeavor unless you have a NICU [neonatal intensive care unit] attached. So I think this just really compounds the problems that we’ve been hearing about staffing, about rural health in general, recruiting, and just makes it one step harder for those departments that are really important for women to get the care they need as they’re giving birth, and just making sure that they’re safe and well-staffed for those appointments leading up to and following the birth as well.

Kenen: Right. And at a time we’re supposedly making maternal mortality a national health priority, right? So you can’t really protect women at risk, and, as Rachel said, it’s during childbirth, but it’s for months after. And without proper care, we are not going to be able to either bring down the overall maternal mortality rates nor close the racial disparities.

Griffin: I was just going to say, I highly recommend a story the New Yorker did this past January, “Did an Abortion Ban Cost a Young Texas Woman Her Life?” It’s a view into many of these different themes and will show you a real human story, a tragic one at that, about what these deserts, how they have consequential impact on people’s lives for both mother and baby.

Rovner: Yeah, and we talked about that when it came out. So if you go back, if you scroll back, you’ll find a link to it in the show notes.

I was going to say March is when we get “Match Day,” which is when graduating medical students find out where they’re going to be completing their training. And we saw just sort of the beginnings last year of kind of a dip in graduating medical students who want to become OB-GYNs who are applying to programs in states with abortion bans. I’ll be really curious this year to see whether that was a statistical anomaly or whether really people who want to train to be OB-GYNs don’t want to train in states where they’re really worried about changing laws.

We have to move on. I want to talk about something I’m calling the most under-covered health story of the month, a huge cyberattack on a company called Change Healthcare, which is owned by health industry giant UnitedHealth [Group]. Change processes insurance claims and pharmacy requests for more than 300,000 physicians and 60,000 pharmacies. And as of Wednesday, its systems were still down a week after the attack.

Rachel, I feel like this is a giant flashing red light of what’s at risk with gigantic consolidation in the health care industry. Am I wrong?

Cohrs: You’re right, which is why a couple of my colleagues did cover it as just this important red flag. And there are new SEC [Securities and Exchange Commission] reporting rules as well that require more disclosure around these kind of events. So I think that will …

Rovner: Around the cyberattacks?

Cohrs: Yes, around the cyberattacks, yes. But I think just the idea that, we’ll talk about this later too, but that Change is owned by UnitedHealth and just so much is consolidated that it really does create risks when there are vulnerabilities in these very essential processes. And I think a lot of people just don’t understand how many health care companies, they don’t provide any actual care. They’re just helping with the backroom kind of operations. And when you get these huge conglomerates or services that are bundled together under one umbrella, then it really does show you how a very small company maybe not everyone had heard of before this week could take down operations when you go to your pharmacy, when you go to your doctor’s office.

Rovner: Yeah, and there are doctors who aren’t getting paid. I mean, there’s bills that aren’t getting processed. Everything was done through the mail and it was slow and everybody said, “When we digitize it, it’s all going to be better and it’s all going to happen instantly.” And mostly what it’s done is it’s created all these other companies who are now making money off the health care system, and it’s why health care is a fifth of the U.S. economy.

But anticipating what you were about to say, Rachel, speaking of the giant consolidation in the health industry by UnitedHealth, I am not the only one, we are not the only ones who have noticed. The Wall Street Journal reported this week that the Justice Department has begun an antitrust investigation of said UnitedHealthcare, which provides not only health insurance and claims processing services like those from Change Healthcare, but also through its subsidiary Optum, owns a network of physician groups, one of the largest pharmacy benefit managers, and provides a variety of other health services. Apparently one question investigators are pursuing is whether United favors Optum-owned groups to the detriment of competing doctors and providers.

I think my question here is what took so long? I know that the Justice Department looked at it when United was buying Change Healthcare, but then they said that was OK.

Cohrs: Yeah. I will say I think this is a great piece of reporting here, and these are excellent questions about what happens when the vertical integration gets to this level, which we just really haven’t seen with UnitedHealthcare, where they’re aggressively acquiring provider clinics. I think it was a home health care company that they were trying to buy as well.

So I think it is interesting because now that the acquisitions have happened on some of these, there will be evidence and more material for investigators to look at. It won’t be a theoretical anymore. So I will be interested to see just how this plays out, but it does seem like the questions they’re asking are pretty wide-ranging, certainly related to providers, but also related to an MLR [medical loss ratio]. What if you own a provider that’s charging your insurance company? How does that even work and what are the competitive effects of that for other practices? So I think …

Rovner: And MLRs, for those who are not jargonists, it’s minimum loss ratios [also known as medical loss ratio], and it’s the Affordable Care Act requirement that insurers spend a certain amount of each dollar on actual care rather than overhead and profit and whatnot. So yeah, when you’re both the provider and the insurer, it’s kind of hard to figure out how that’s going.

I am sort of amazed that it’s taken this long because United has been sort of expanding geometrically for the last decade or so.

Kenen: It’s sort of like the term vertical integration, which is the correct term that Rachel used, but as she said that, I sort of had this image of a really tall, skinny, vertical octopus. There’s more and more and more things getting lumped into these big, consolidating, enormous companies that have so much control over so much of health care and concentrated in so few hands now. It’s not just United. I mean, they’re big, but the other big insurers are big too.

Cohrs: Right. I did want to also mention just that we’re kind of seeing this play out in other places too, like Eli Lilly creating telehealth clinics to prescribe their obesity medications. Again, there’s no evidence that they’re connected to this in any way, but I think it is going to be a cautionary tale for other health care companies who are looking into this model and asking themselves, “If UnitedHealthcare can do it, why can’t we do it?” It will be interesting to see how this plays out for the rest of the industry as well.

Rovner: Yeah, when I started covering health policy, I never thought I was going to become a business reporter, but here we are.

Moving on to “This Week in Health Misinformation,” we have Joanne, or rather an interesting, and as it turns out, extremely timely story about vaccines that Joanne wrote for Politico Magazine. Joanne, tell us your thesis here with this story.

Kenen: I wanted to look at how much the public health and clinician community had learned about combating misinformation, sort of a real-life, real-time unfolding before our eyes, which was the rollout of the RSV vaccine.

And I think the two big takeaways, I mean, it’s a fairly … I guess there were sort of three takeaways from that article. One, is they’ve learned stuff but not enough.

Two, is that it’s not that there was this huge campaign against the RSV vaccine, there is misinformation about the RSV vaccine, but basically it just got subsumed into this nonstop, ever-growing anti-vaccine movement that you didn’t have to target RSV. Vaccines is a dirty word for a section of the population.

And the third thing I learned is that the learning about fighting disinformation, the tools we have, you can learn about those tools and deploy those tools, but they don’t work great. There’ve been some studies that have found that what they call debunking or fact-checking, teaching people that what they believe is untrue, that they say, “Ah, that’s not right,” and then a week later they’re back to their original, as little as one week in some studies. One week, you’re back to what you originally thought. So we just don’t know how to do this yet. There are more and more tools, but we are not there.

Rovner: Well, and I say this story is timely because we’re looking at a pretty scary measles outbreak in Florida and a Florida surgeon general who has rejected all established public health advice by telling parents it’s up to them whether to send their exposed-but-unvaccinated children to school rather than keep them home for the full 21 days that measles can take to incubate.

The surgeon general has been publicly taken to task by, among others, Florida’s former surgeon general. I can remember several measles outbreaks over the years, often in less-than-fully-vaccinated communities, but I can’t remember any public health officials so obviously flouting standard public health advice.

Joanne, have you ever seen anything like this?

Kenen: No. It’s like his public stance is like, “Measles, schmeasles.” It’s like a parent has the right to decide whether they’re potentially contagious, goes to school and infects other children, some of whom may be vulnerable and have health problems. It is this complete elevation of medical liberty or medical freedom completely disconnected to the fact that we are connected to one another. We live in communities. We supposedly care about one another. We don’t do a very good job of that, and this is sort of the apotheosis of that.

Rovner: And one of the main reasons that public schools require vaccines is not just for the kids themselves, but for kids who may have younger siblings at home who are not yet fully vaccinated. That’s the whole idea behind herd immunity, is that if enough people are vaccinated then those who are still not fully vaccinated will be protected because it won’t be floating around. And obviously in Florida, measles, which is, according to many doctors, one of the most contagious diseases on the planet, is making a bit of a comeback. So it is sort of, as you point out, kind of the end result of this demonization of all vaccines.

Kenen: And our overall vaccination rate for childhood immunization has dropped and it’s dropped, I’d have to fact-check myself, I think what you need for herd immunity is 95% and it’s …

Rovner: I think it’s over 95.

Kenen: And that we’re down to maybe 93[%]. I mean, this number was in that article that I wrote, but I wrote it a few weeks ago and I may be off by a percentage point, so I want to sort of clarify that nobody should quote me without double-checking that. But basically, we’re not where we need to be and we’re not where we were just a few years ago.

Rovner: Another space we will continue to watch.

Well, that is this week’s news. Now we will play my interview with law professor Greer Donley, and then we will come back and do our extra credits.

I am thrilled to welcome to the podcast, Greer Donley, associate dean for research and faculty development and associate professor of law at the University of Pittsburgh Law School. She’s an expert in legal issues surrounding reproductive health in general and abortion in particular, and someone whose work I have regularly relied on over the past several years, so thank you so much for joining us.

Greer Donley: I’m so happy to be here. Thanks for having me.

Rovner: So I’ve asked you here to talk about how an anti-abortion president could use an 1873 law called the Comstock Act to basically ban abortion nationwide. But first, because it is still so in the news, I have to ask you about the controversy surrounding the Alabama Supreme Court’s ruling that frozen embryos for in vitro fertilization are legally children. Do you think this is a one-off, or is this the beginning of states really, fully embracing the idea of personhood from the moment of fertilization?

Donley: Man, I have a lot to say about that. So I’ll start by saying that first of all, this is the logical extension of what people have been saying for a long time about, “If life starts at conception, this is what that means.” So in some sense, this is one of those things where people say, “Believe people when they tell you something.” Folks have been saying forever, “Life starts at conception.” This is a logical outgrowth of that. So in some sense, it’s not particularly surprising.

It’s also worth noting that states have been moving towards personhood for decades, often through these kind of state laws, like wrongful death, which is exactly what happened here. So this is the first case that found that an embryo outside of a uterus was a children for this purpose of wrongful death, but many states had been moving in the direction of finding a fetus or even an embryo that’s within a pregnant person to be a child for the purpose of wrongful death for a while now. And that has always been viewed as the anti-abortion movement towards personhood. In some sense, this is just kind of the logical outgrowth, the logical extension, of the personhood movement and the permission that Dobbs essentially gave to states to go as far as they wanted to on this question.

So whether or not this is going to be the beginning of a new trend is, I think, in my mind, going to be really shaped by public backlash to the Alabama decision, particularly. I think that many folks within the anti-abortion movement, again, they mean what they say. They do believe that this is a life and it should be treated as any other life, but whether or not they are going to perceive this as the ideal political climate in which to push that agenda is another question.

And my personal view is that, given the backlash to the Alabama Supreme Court, you might see folks retreating a little bit from this. I think we’re starting to see a little bit of that, where more moderate people within the Republican Party are going to say, “This is not the moment to go this far,” or maybe even, “I’m not sure I actually support this logical outgrowth of my own opinion,” and so we’re going to have to kind of …

Rovner: “I co-sponsored this bill, but I didn’t realize that’s what it would do.”

Donley: Exactly. Right? So we’re going to, I think, really have to see how people’s views change in response to the backlash.

Rovner: Let us go back to Comstock. Who was this person, Anthony Comstock? What does this law do and why is it still on the books 151 years after it was passed?

Donley: Ugh, yes, OK. So Anthony Comstock, he is what people often call, “The anti-vice crusader.” This law passed in 1873. It’s actually a series of laws, but we often compile them and call them the Comstock Act.

The late 1800s were a moment of change, where many people in this country were for the first time being exposed to the idea that abortion is immoral for religious reasons. Before that for a long time, in the early 1800s, people regularly purchased products to try to what they call, “Bring on the menses,” or menstrual regulation. So it was not uncommon. It was a fairly commonly held view up until late 1800s that the pregnancy was nothing until it was a quickening, there was a quickening where the pregnant person felt movement.

So Comstock was one of the people who was really kind of a part of changing that culture in the late 1800s, and he had the power as the post office inspector of investigating the mail throughout our country. So he was influential not only in helping to pass a law that made it illegal to ship through interstate commerce all sorts of things that he considered immoral, which explicitly included abortion and contraception, but also used vague terms like “anything immoral.” And he was the person that was then in charge of enforcing those laws by actually investigating the mail. His investigations led to pretty horrible outcomes, including many people killing themselves after he started investigating them for a variety of Comstock-related crimes at the time.

So obviously, this law was passed before women had the right to vote, in a completely different time period than we exist today, and it really remained on the books by an accident of history, in my mind.

So in the early 1900s, there was a series of cases. This was the moment where we particularly saw a huge movement towards birth control. So as that movement was going on, you saw a lot of litigation in the courts that were interpreting the Comstock laws related to contraception, finding that it had to be narrowly limited to only unlawful contraception or unlawful abortion. Because the Comstock laws, by its terms, which this should shock everybody who’s hearing me, has literally no exceptions, not even for the life of the pregnant person. And it is so broad that it would ban abortion nationwide from the beginning of a pregnancy without exception. Procedural abortion, pills, everything.

Rovner: And people think of this as the U.S. mail, but it’s not just the U.S. mail. It’s basically any way you move things across state lines, right?

Donley: Right. Because we live in a national economy now, so there’s nothing in medicine that exists in a purely intrastate environment. So every abortion provider in the country is dependent on them and their state mail to get things that they need for procedural abortion and pills.

In the early to mid-1900s, right around the 1930s, there was a series of cases that said this law only applied for unlawful contraception and abortion because they had to read that term into the law. Eventually in the late 1930s, you saw the federal government stop enforcing it completely. And then you had the constitutional cases came out that found a right to contraception and abortion, and so the law was presumed unconstitutional for half a century. No one was repealing it because everyone assumed that it was never going to come back to life. In comes Dobbs, in come the modern anti-abortion movement, and now we are here.

Rovner: Yeah. So how could a President Trump, if he returns to the White House, use this to ban abortion nationwide?

Donley: Yes, because this law was never repealed, and because the case that presumptively made it unconstitutional, Roe v. Wade, and the cases that came after that, are now no longer good law, presumptively the law, like a zombie, comes back to life.

And so the anti-abortion movement is now trying to reinterpret the law, right? We’re talking about such a long period of time and all those 1930s cases, since that time period, you have the rise of what we call textualism, which is a theory of statutory interpretation that really likes to stick to the text. That was something that’s been around for a while, but in modern jurisprudence, that has become increasingly important, and the anti-abortion movement sees, “Well, all these judges are now textualists, and we can say this law is still good. By its clear terms, it bans shipping through interstate commerce anything that could be used for an abortion. Voila. We have our national abortion ban without having to get a single vote in Congress. All we need is a Republican president that will enforce the law as it’s written and on the books today,” and that is their theory.

Rovner: And that’s included, I think, in one of the briefs that was filed today in the abortion pill case, right?

Donley: Absolutely. In that case, that’s a case concerning the regulation of mifepristone, one of the abortion pills, that’s before the Supreme Court this summer. You had parties saying, “The law is clear and it is as broad as it’s written,” essentially.

Rovner: Well, this doesn’t apply to contraception anymore, right?

Donley: Right. So right after the Supreme Court case Griswold [v. Connecticut], which found a constitutional right to contraception, but before Roe, you had the Congress actually repealed the portion of Comstock related to contraception. But again, it was before Roe, so they didn’t repeal the part related to abortion, and then Roe came in and made that part presumptively unconstitutional.

Of course, going back in time, we would say, “You got to repeal that law. You have no idea what the future may be,” but I don’t think people really saw this moment coming. They should have. We should have all been preparing for this more. But, yeah.

Rovner: One of the things that I don’t think I had appreciated until I read the op-ed that you co-wrote, thank you very much, is that there could be a reach-back here. It’s not even just abortions going forward, right?

Donley: Right. So the idea here is that, generally, laws have a statute of limitations, right? So you could potentially have a President Trump come in, say that he’s going to start enforcing this law immediately, and even if the second Jan. 1 comes, people stop shipping anything through interstate commerce, he could still go back and say, “Well, the statute of limitations is five years.” So you go back in time for five years and potentially bring charges against someone.

So one of the important pieces of advocacy that we might have in this moment is to really encourage President Biden, if he were to not win the election, to preemptively essentially pardon anybody for any Comstock-related crimes to make sure that that can’t be used against them. That’s a power he actually has and will be a very important power for him to use in that instance. But it’s quite alarming how Comstock could be used in this period, but also retrospectively.

Rovner: Last question, and I know the answer to this, but I think I need to remind listeners, if Congress doesn’t have to pass anything to implement a nationwide ban, why haven’t previous anti-abortion Republican presidents tried to do this?

Donley: While Roe and [Planned Parenthood of Southeastern Pennsylvania v.] Casey were good law, there was no way that they could possibly do that. It would’ve been unconstitutional for them to try to criminalize people for exercising their constitutional right to reproductive health care for abortion. So we’re really in a new moment where essentially the Supreme Court overturned those cases while President Biden was in office, and so the real question is whether a Republican administration could come in and change everything.

Rovner: We shall see. Greer Donley, thank you so much for coming to explain this.

Donley: Thank you for having me.

Rovner: OK, we are back. 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, you were the first to choose this week. Why don’t you go first?

Cohrs: The article I chose is in The New York Times. The headline is “$1 Billion Donation Will Provide Free Tuition at a Bronx Medical School” by Joseph Goldstein. And it’s about how this 93-year-old widow of an early investor in Berkshire Hathaway has given $1 billion to a medical school in the Bronx to pay for students’ tuition. And I think her idea behind it is that it will open up the pool of students who might be able to go to medical school. I imagine applications might increase to this school as well. And she was a professor at the school during her career as well.

To me, it’s not a scalable solution necessarily for the cost of medical education, but I think it does highlight how broke everything is. When we’re talking about Medicare payment to doctors, I think one of the arguments they always use is doctors have debt and there’s inflation and costs have gone up so much, and I think the cost of education in this country certainly is one factor in that, that it’s really hard to address from a simply health care policy standpoint.

So I think not necessarily a scalable solution, but will definitely make a difference in a lot of students’ lives and just give them more freedom to practice in the specialty that they might want to, which we all know we need more primary care doctors and doctors in a variety of different settings. So I think it’s a rare piece of good news.

Rovner: Yeah, it might not be scalable, but it’s not the first, which is kind of … I remember, in fact, NYU is now having a no-tuition medical school. UCLA, although I think UCLA is only for students who can demonstrate financial need. But in doing those earlier stories, and I have not updated this, at the time, which is a couple of years ago, the average medical student debt graduating is over $250,000. So you can see why they feel like they need to be in more lucrative specialties because they’re going to be paying their student loans back until they’re in their 40s, most of them. This is clearly a step in that direction.

Riley, why don’t you go next?

Griffin: Yeah. I wanted to share a story that I’ve been fairly obsessed with over the last month. It’s one of my own. It’s “US Seeks to Limit China’s Access to Americans’ Personal Data.” This week, the Biden administration announced that it is issuing, or has at this point issued, an executive order to secure Americans’ sensitive personal data, and we broke this story about a month ago.

Why it is so interesting to the health world is, one of the key parts that was a motivating factor in putting together this executive order, is DNA, genomic data. The U.S., the National Security Council, our national security apparatus is really concerned about what China and other foreign adversaries are doing with our genetic information. And we can get more into that in the story itself, but it is fascinating, and now we’re seeing real action to regulate and protect and ensure that that bulk data doesn’t get into the hands of people who want to use it for blackmail and espionage.

Rovner: Yeah, it was super scary, I will say. Joanne?

Kenen: I couldn’t resist this one. It’s in Axios. It’s by Tina Reed, and the headline is “An Unexpected Finding Suggests Full Moons May Actually Be Tough on Hospitals.” Caveat, before I go on, there is research out there that proves what I’m about to say is wrong.

But anyway, a company that makes panic buttons, so a hospital security company that one of the things they do is provide panic buttons, they did a study of how and when these panic buttons are used, and they found they go up during full moons. And they also found that other things rise during full moons. GI [gastro-intestinal] disorders go up, ambulance rides connected to motor vehicle accidents go up, and psychiatric admissions go up. So maybe that research that I cited at the beginning saying this is hogwash needs to be reevaluated in some subcategories.

Rovner: There’s always new things to find out in science.

My extra credit this week is from ProPublica. It’s called “Their States Banned Abortion. Doctors Now Say They Can’t Give Women Potential Lifesaving Care,” by Kavitha Surana. It’s another in a series of stories we’ve seen about women with serious pregnancy complications that are not immediately life-threatening, but who nevertheless can’t get care that their doctors think they need.

This story, however, is written from the point of view of the doctors, specifically members of an abortion committee at Vanderbilt Hospital in Nashville who are dealing with the Tennessee ban that’s one of the strictest in the nation. It’s really putting doctors in an almost impossible position in some cases, feeling that they can’t even tell patients what the risks are of continuing their pregnancies for fear of violating that Tennessee law. It’s a whole new window into this story that we keep hearing about and a really good read.

OK. 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 very patient technical guru, Francis Ying, and our editor, Emmarie Huetteman.

As always, you can email us your comments or questions. We’re at whatthehealth@kff.org, or you can still find me hanging around at Twitter, @jrovner, or @julierovner at Bluesky and @julie.rovner at Threads.

Joanne, where are you hanging these days?

Kenen: Mostly at Threads, @joannekenen1. I still occasionally use X, and that’s @JoanneKenen.

Rovner: Riley, where can we find you on social media?

Griffin: You can find me at X @rileyraygriffin.

Rovner: And Rachel?

Cohrs: I’m at X @rachelcohrs and on LinkedIn more these days, so feel free to follow me there.

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

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In a study published in the renowned medical journal Circulation, the findings of a review of data from three clinical trials challenge current best practice for use of the drug for primary prevention of heart disease or stroke - otherwise known as atherosclerotic cardiovascular disease.

The research examined the results from clinical trials involving more than 47,000 patients in 10 countries, including the US, the UK and Australia, which were published in 2018.

The analysis focused on findings for a subgroup of 7,222 patients who were already taking aspirin before the three trials commenced. Those studied were at increased risk for cardiovascular disease and were taking aspirin to prevent the first occurrence of a heart attack or stroke.

The data showed a higher risk of heart disease or stroke-12.5% versus 10.4% - for patients who were on aspirin before the trials and who then stopped, compared to those who stayed on the drug.

Analyses also found no significant statistical difference in the risk for major bleeding between the two groups of patients.

The research was led by Professor J. William McEvoy, Established Professor of Preventive Cardiology at University of Galway and Consultant Cardiologist at Saolta University Health Care Group, in collaboration with researchers in University of Tasmania and Monash University, Melbourne.

Professor McEvoy said: “We challenged the notion that aspirin discontinuation is a one-size-fits-all approach.”

The research team noted results from observational studies which suggest a 28% higher risk of heart disease or stroke among adults who were prescribed aspirin to reduce the risk for a first heart attack or stroke, but who subsequently chose to stop taking the aspirin without being told to do so by their doctor.

Based in large part on three major clinical trials published in 2018, international guidelines no longer recommend the routine use of aspirin to prevent the first occurrence of heart attack or stroke.

Importantly, aspirin remains recommended for high-risk adults who have already had a heart disease or stroke event, to reduce the risk of a second event.

The move away from primary prevention aspirin in recent guidelines is motivated by the increased risk of major bleeding seen with this common medication in the three trials, albeit major bleeding is relatively uncommon on aspirin and was most obvious only among trial participants who were started on aspirin during the trial, rather than those who were previously taking aspirin safely.

These trials primarily tested the effect of starting aspirin among adults who have not previously been treated with the drug to reduce the risk of atherosclerotic cardiovascular disease. Less is known about what to do in the common scenario of adults who are already safely taking aspirin for primary prevention.

Professor McEvoy said: “Our findings of the benefit of aspirin in reducing heart disease or stroke without an excess risk of bleeding in some patients could be due to the fact that adults already taking aspirin without a prior bleeding problem are inherently lower risk for a future bleeding problem from the medication. Therefore, they seem to get more of the benefits of aspirin with less of the risks.

“These results are hypothesis-generating, but at present are the best available data. Until further evidence becomes available, it seems reasonable that persons already safely treated with low-dose aspirin for primary prevention may continue to do so, unless new risk factors for aspirin-related bleeding develop.”

Reference:

Ruth Campbell, Mark R. Nelson, John J. McNeill and John W. McEvoy, Outcomes After Aspirin Discontinuation Among Baseline Users in Contemporary Primary Prevention Aspirin Trials: A Meta-Analysis, Circulation, DOI: 10.1161/CIRCULATIONAHA.123.065420.

Santo Domingo.- The president of the Dominican Medical College, Waldo Ariel Suero, announced that they, along with the Specialized Medical Societies, will appeal to the National Social Security Council (CNSS) for reconsideration of provisions in the Regulations on Infractions and Sanctions approved on February 15, 2024, through resolution 584-03.

Suero expressed suspicion regarding the regulations, pointing out that of the 37 infractions listed for the ARS/IDOPPRIL, only 6 are classified as serious, 15 as moderate, and 16 as minor. For the providers, out of the 28 listed, 9 are considered serious, 12 moderate, and only 7 mild. He suggested that this reflects a bias in favor of ARS/IDOPRIL, which operate as intermediaries in Social Security.

The regulations, developed by the Permanent Commission of Regulations of the CNSS, were prepared without representation from doctors and the CMD. Suero argued that the regulations include sanctions for Health Service Providers that directly impact the medical profession and health centers.

He criticized the lack of distinction between institutional providers (Health Centers) and Medical Professionals in the regulations, noting that they contain sanctions, including criminal ones and fines of up to 5.8 million pesos, without specifying who will receive the withheld money.

Suero argued that the regulations implicitly violate the right of Specialized Medical Societies and the Dominican Medical Association to initiate actions for collective claims for rate improvements and professional fees. The appeal contends that the regulations and the procedure for their approval violate due process, the right to collective claims, the right to participate in deliberations for administrative provisions, and the right to health recognized in the constitution’s article 61.

he department of dermatology at Saint Vincent de Paul Hospital, Hospital Group of the Catholic Institute of Lille in France, and colleagues wrote. “However, little is known about the

Pharmaceutical companies that manufacture insulin made headlines last year when they voluntarily agreed to provide discount cards that lower the monthly cost of insulin for many people to $35. 

But getting your hands on this card — and persuading a pharmacist to accept it — can be a hassle.

In this episode of “An Arm and a Leg,” producer Emily Pisacreta speaks with “insulin activists” and pharmaceutical experts to find out what this change in prices means for people with diabetes and why the fight for affordable insulin isn’t over yet.

Dan Weissmann

@danweissmann

Host and producer of "An Arm and a Leg." Previously, Dan was a staff reporter for Marketplace and Chicago's WBEZ. His work also appears on All Things Considered, Marketplace, the BBC, 99 Percent Invisible, and Reveal, from the Center for Investigative Reporting.

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Transcript: Wait, Is Insulin Cheaper Now?

Note: “An Arm and a Leg” uses speech-recognition software to generate transcripts, which may contain errors. Please use the transcript as a tool but check the corresponding audio before quoting the podcast.

Dan: Hey there. Right after the holidays, I got an email from a listener named Brianna.It started, “Happy new year Dan! I was just reading the news about the price of insulin going down to $35! Is that for everyone?”

And I was like, Huh. I had a sense that there was some news about the price of insulin, but 35 dollars a month for everyone? That sounded like a BIG reduction. And big news.I googled the latest stories, and I was… not totally sure what I was seeing.

I was definitely seeing some new stories about people paying 35 bucks from here on out. And there seemed to be some federal law involved, and politicians were patting themselves on the back. But it just wasn’t totally clear: Was insulin now 35 dollars for everyone? Did the outrageous price of insulin get solved while I wasn’t looking?

And I mean, I’ve kinda been looking. We’ve done a couple of episodes about the price of insulin already — because insulin is iconic. It represents the wild cost of prescription drugs in this country. More than 8 million Americans take insulin to treat their diabetes – and for some, going without it could actually kill you.

And its price got jacked up so much — huge multiples over like ten years — — that one in four of those people who couldn’t go without… took to rationing: Seeing how much they could go without, short of actually dying.

So I asked our senior producer Emily Pisacreta to take the case.

Emily: I feel more like the senior insulin correspondent, which is fine with me as the resident type 1 diabetic! And a lot has happened since the last time we talked about insulin on this show. We really do need an update.

Dan: This is an “Arm and a Leg”, a show about why healthcare costs so freaking much, and what we can maybe do about it. I’m Dan Weissmann, I’m a reporter and I like a challenge. So our job here is to take one of the most enraging, terrifying, depressing parts of American life, and bring you something entertaining, empowering and useful.

Today we have a question: what’s going on with insulin? Is it $35 now?

Emily: Well, there have been some BIG improvements — bigger than I thought when I started reporting. A lot of people can get their monthly supply of insulin for just $35. But it is oversimplified to say it just costs $35 now. And the people who have been fighting to lower the price of insulin over the past decade? They’re still very pissed. So let me walk you through what changed, what led to those changes, and what’s still unresolved.

Dan: OK!

Emily: For years now, there’s been a giant push from people with diabetes to get the federal government to do something about the high cost of insulin. In 2022, finally something came through. I’m talking about a provision in Inflation Reduction Act.

Dan: Yes– I remember this– the Inflation Reduction Act was a big infrastructure bill that included, like renewable energy subsidies, and– honestly, this is the reason that I remember the bill, because we did an episode about this part–  letting medicare negotiate some drug prices?

Emily: Exactly. It said people on Medicare would be able to get a month’s supply of insulin for no more than $35 out of pocket. But of course that left a big gaping hole. BECAUSE that’s cool for people on Medicare, but what about the rest of us? And the pharma companies were feeling the heat. Here’s President Biden in his State of the Union last year:

President Biden: Big pharma has been unfairly charging people hundreds of dollars, four to $500 a month making record profits. Not anymore. Not anymore.

Emily: By the way, those pharma companies? There’s three of them who make insulin.

That’s the American company Eli Lilly, the Danish company Novo Nordisk, and the French company Sanofi. OK so: not long after  Joe Biden talked about their record profits, the insulin makers were back in the news. …

Eli Lilly was the first to announce they were going to slash prices on several of their most popular insulins, and limit out of pocket spending to $35 a month.

Fox News: This is a big story.

 Next, Novo Nordisk and Sanofi made similar announcements. 

CNN: Millions of Americans are affected by this major news this morning for millions of people suffering from diabetes and high prescription drug costs.

Basically, the insulin manufacturers all said hey, you’re not covered by this Medicare thing? We’re going to bring your copay down to $35 ourselves. So if you have commercial insurance Print out this card, take it to the pharmacy, and your copay will be no more than $35 for a month’s supply of insulin.

Dan: And what if you’re uninsured?

Emily: Well, they have a card for that, too.

Dan: OK so what I’m hearing is you need a card.

DAN: Yes. How do you get one?

Emily: The insulin makers set special phone numbers you can call. Or you can visit their websites, fill out a little form, and download the card.

Dan: Sounds simple, unless I’m missing something?

Emily: In all honesty, I had no problem with those steps. But I wouldn’t assume that’s the case for everyone. And I’m also not rationing insulin right now.

Zoe Witt: When you are rationing insulin, maybe you aren’t even fully rationing insulin yet, but you don’t know how you’re going to get Your next prescription, your next fill of insulin…You are in crisis. Like, you, you do not have the capability to sift through these websites. It’s very confusing. It’s very overwhelming.

Emily: This is someone who frequently speaks to people struggling to afford insulin.

Zoe Witt: my name is Zoe Witt. I work with Mutual Aid Diabetes.

Emily: Mutual Aid Diabetes. That’s an all volunteer group that has banded together to help diabetics get what they need, when they need it. They help people with cash and with free diabetes supplies, including insulin, no questions asked. That means Zoe knows the ins and outs of every obstacle to getting insulin.

Zoe Witt: Our healthcare system is like a whack a mole from hell.

Emily:  And Zoe reminds me: if you’re not taking enough insulin, you probably feel awful. Maybe not even thinking straight. And it can affect your eyes, making it hard to read.

Zoe Witt: It just is unmanageable

Emily: Zoe says they talk with people all the time who are too stressed out or too debilitated to download these cards and use them.  Diabetes folks walk people through the process. And once someone has the card… Mutual Aid Diabetes gives people the 35 bucks, too, if they say they need it. Because $35 can be a barrier for a lot of people. And it’s actually $70 sometimes if you use 2 types of insulin at once, which lots of people do… myself included.

Dan: Wow. OK. But then once people have the cards they typically have no problem?

Emily: Well, your pharmacist has to know what they’re doing, too. So sometimes it means a patient having to educate their pharmacist– or even bring the doctor in to help troubleshoot — which is no picnic. And people with diabetes are always having to deal with insurance roadblocks at the pharmacy, so I don’t want to make anything sound simpler than it is. 

Dan: It’s like a whack a mole from hell!

Emily: Exactly! And the cards don’t solve everything. Especially this: if you have insurance, these cards only apply to the insulin your insurance plan already covers. If you normally need a prior authorization to get the right insulin for you… that is still the case.

Dan: Right. Okay.  like prior authorization is this roadblock to getting all kinds of treatment, that you and your doctor agree that you should have, and your insurance company can say, we disagree. We’re s not authorizing this. And then you’re stuck. 

Emily: Right. 

Dan:But in terms of what the pharma companies. can do to kind of offer you a deal. They’re basically doing it. Is that right? 

Emily: I think that’s fair to say. 

Dan: That’s super interesting. All right. So it’s not solved, but this is a big step forward. And what’s not solved is: some people are still on the hook for the list price for insulin — the price without any discounts or insurance or whatever. But you found big improvements there too, right? 

Emily: Yes! When the companies announced all these discount cards, they announced a whole other big change, too. Slashing the list prices of a bunch of different insulins by up 75%. So a vial that once was north of $300 is now being listed at around $70.

Dan: OK, that sounds like a big improvement.

Emily: It’s a big, big deal. Actual price reductions are what diabetes advocates have been demanding all along. And… while these are still the highest prices in the world for these same insulins, to see them drop from triple to double digits, it’s wild.

Dan: I sense that there’s a “but” here.

Emily: Well, the Big Three didn’t lower the price of every type of insulin, only ones that have been around since the 1990s or early 2000s. Newer insulins that work faster or last longer are not included here.

Dan: And I’m guessing not all insulins work the same way.

Emily: Right. Some people can switch between types or brands of insulin easily. For other people, there can be allergies or one works better with their body with another kind. It’s complicated. It’s medicine! AND… there have been some issues with pharmacies actually stocking lower list price insulin. That is a whole ‘nother saga… an episode for another day. But the important thing is… a bunch of insulin is a lot cheaper now.

Dan: Wow. Emily, you said right at the top: The changes here are bigger and better than you realized before you started reporting. 

Emily: Yes but there’s still a lot more to say. 

Right. After the break, we’ll’ hear from you about why these changes happened NOW. And what it means for people with diabetes and really all of us…

[midroll]

So. We have seen some big changes in the last year — including DRUG COMPANIES expanding their discount programs and lowering the sticker prices on insulin, dramatically. Why now? I’m guessing this wasn’t because they had a big change of heart.

Emily: I can’t speak to what’s in pharma’s hearts. But I did talk to someone who knows a lot about pharma’s brain.

Ed Silverman: my name is Ed Silverman, and I work at Stat News, a health and life sciences website,

Emily: I’m a big fan of Stat News

Dan: Me too, man! Their reporting is great.

Emily:  And Ed Silverman. He’s been covering the pharmaceutical industry for almost 30 years. He thinks activism from people with diabetes over the years created political pressure that played a big role in the decision to slash prices. But there was also something kind of hidden at work.

Ed Silverman: It’s not altruism, here was a real mechanism, government mechanism in place that helped change the equation and therefore the thinking back at the companies.

Dan: OK… what is he talking about?

Emily: So, Dan: do you remember the stimulus bill, the American Rescue Plan?

Dan: I’m starting to feel like this episode is a quiz on recent-ish legislation. And I think I’m gonna do pretty well here:.The American Rescue Plan was a trillion dollar stimulus that Joe Biden got passed right after he got into office– am I right?

Emily: OK, hotshot. Do you remember how in part 8 section 9816 they sunsetted the limit on the maximum rebate for single source drugs and innovator multiple source drugs?

Dan:  Um, busted. No. 

Emily: Ok so here’s the deal: it’s obviously kinda wonky so I’ll simplify– in that little section Congress made a tweak to Medicaid, basically raising penalties on drug-makers for jacking up prices too far, too fast. So if you’re a pharma company who has raised the price of a drug by a lot very quickly, which is true of insulin, and a lot of people on Medicaid use your drug, which is also true of insulin, then you have to pay a big penalty. In the case of insulin, that penalty would be more than you’d make selling the insulin to Medicaid. A LOT more: So, unless you bring the price back down, you’re going to owe Medicaid a lot of moolah. And those penalties were set to kick in January 1st 2024.

Dan: So you’re telling me: Part of what the pharma companies did here came right out of a small part of a giant federal law from 2021.

Emily: Yep. And there’s another big wheel turning in the background here. Novo Nordisk and Eli Lilly, two companies who really got their start by selling insulin, now make other diabetes drugs — drugs that are now increasingly used for weight loss. And it’s a bonanza.

GMA: It is literally the hottest drug in the country right now.

Fox News: all people are talking about these days is Ozempic, wegovy. Oh my gosh, this person lost 20 pounds. This person lost 50 pounds.

Ozempic Ad: [Jingle:] “Oh, Oh, Oh, Ozempic![Announcer:] Once weekly Ozempic is helping many people with type 2 diabetes like James lower their blood sugar.

Emily: Drugs like Ozempic, Wegovy, Mounjaro. They’ve been in super high demand. And there’s been a ton of hype about their various potential health benefits. For weight loss, for heart health. Scientists are even interested in whether it can help people with substance use disorders. Meanwhile, for Eli Lilly and Novo Nordisk, the returns on these drugs dwarf anything else they’re selling. Novo Nordisk even became the biggest company in Europe – for like a minute… but still.

Dan: OK, this is interesting, but what does it have to do with the price of insulin?

Emily: I’d wondered… maybe these companies can just better afford to buy some political peace by lowering insulin prices, because they are making so much bank on these new drugs, ? Ed Silverman had a take on that.

Ed Silverman: It makes perfect sense that these cash cows, these medicines that are used for diabetes and, weight loss are going to become increasingly important to their bottom line more than other medicines

Emily: More than insulin. And they’re selling so much so fast, they can hardly keep up with demand. Which could end up affecting people who need insulin.

Dan: Wait, how?

Emily:  Look, for example, in November, Novo Nordisk said they were investing 3 and half billion dollars into ramping up production of injection pens for  Wegovy, one of their top drugs in this category. Less than a week later, Novo announced they would be phasing out one of their insulin products  from the US market – an insulin called Levemir. It’s one of the insulins whose prices they just dropped. And… coincidence… Levemir also comes in a pen.

Dan: So Novo Nordisk is phasing out an insulin pen so they can make more Wegovy pens?

Emily: Well, we don’t know that for sure. But Novo Nordisk did tell me that “manufacturing constraints” were part of why they’re dumping Levimir. They said it was one of several reasons and also wrote: “We made this decision after careful consideration and are confident that given the advanced notice, U.S. patients will have access to alternative treatments and can transition to other options.    

Dan: Huh. OK.

Emily: But even if pulling this insulin Levemir off the market had nothing to do with their trouble meeting the demand for their big blockbuster drug… it brings to mind an important question about all the changes we talked about today — whether it’s the copay savings or the lowered list prices. Here’s Ed Silverman.

Ed Silverman there’s no guarantee that the companies will keep these in place. Maybe after time, some of the attention on insulin is diverted and maybe eighteen months from now, one company might quietly roll back some of the Benefits, if you want to use that word, there’s nothing requiring them to maintain the steps they’ve taken.

Emily: I asked all three insulin makers about this. None of them promised there would never be any backsies. Lilly wrote back “Lilly is committed to ensuring all patients can access any Lilly medicine they need” — and touted their efforts to date. Similarly, Sanofi wrote “We continually review our affordability offerings to support our aim that no one should struggle to pay for their insulin. Novo Nordisk’s response was “Novo Nordisk increases the price of some of our medicines each year, in response to changes in the healthcare system, market conditions, and the impact of inflation.” 

Dan: Yeah, that especially does not sound like a pinky-swear, no-backsies kind of response.   

Emily: AND  that’s not much comfort for insulin activists. Folks like Shaina Kasper, who works for T1International. They’re a group that’s been at the forefront of this fight for years.  I Asked her…

Emily-on-tape: So is this issue of high insulin prices just resolved now?

Shaina Kasper: No, it hasn’t been. It’s been really frustrating…

Emily Shaina and others are worried that the announcements from the manufacturers about savings cards and voluntary list price reductions will take the pressure off the government to do something more sweeping. Because for now…

Shaina: The manufacturers really hold all of the power here And if patients are counting on these programs to literally be able to survive, that has life and death consequences

Dan: This question about who holds the power, it reminds me of a story we did a few months ago… the one about how the writer John Green led a kind of online crusade targeting the drug-maker Johnson & Johnson. And how, even though the pressure campaign worked — J & J ended up allowing lower-priced versions of an important tuberculosis drug — activists who worked on the issue were like: It’s a problem that Johnson & Johnson has the power to say yes or no here..

Emily: Exactly. That which pharma giveth, pharma can taketh. At least the way things are set up now. Now I should say, all three companies told me they plan to continue their affordability offerings. But if insulin continues to be the poster child for high drug prices, prices virtually everyone in America agrees are too high…it does raise the question: are voluntary programs from pharmaceutical companies the solution we want? To Zoe from Mutual Aid Diabetes, the answer is no. They find these manufacturer savings cards kind of a bitter pill… no pun intended.

Zoe Witt: there’s certainly no justice in these programs, 

Emily: And zoe for one would say that justice is overdue. 

Zoe Witt: These companies have price gouged us. for years, making obscene amounts of money. Then, presumably, as, we’re often told is the justification for these ridiculous prices, they did research and development for more diabetes drugs, which are Ozempic, Monjoro, etc. And now, these companies, for, the next 15 years, are set to make, billions and billions of dollars, on these drugs,

Emily: I asked the big three insulin manufacturers about what Zoe said – about how angry folks like them are over the cost of insulin. Novo Nordisk said “we continually review and revise our offerings as well as work with diverse stakeholders to create solutions for differing patient needs. ”  And Sanofi and Lily both said something very similar.

Emily: So… in the end– or at least for now– here’s the answer to our listener’s question…. There are more avenues than ever to get a month’s supply of insulin for $35. Great. It may be a lot easier to avoid rationing your insulin now than it was a couple years ago. That’s also really great. But people with diabetes do not think this fight is over.

Dan: So what DO they want?

Emily: Some people still want the federal government to just put a cap on what people pay for insulin, like by law.. Others are working to build alternatives to the existing pharmaceutical industry, like California’s CalRx program.

Dan: Cal Rx… now you’re calling back our story from the last time we talked about insulin.

Emily: Yep, Cal Rx is the state of California’s attempt to enter the insulin market, to introduce some low priced generics and sell them essentially at cost. Other states are joining in. Even if some of these specific plans fall apart — even if California somehow can’t get its government-sponsored insulin to market, even if Pharma rolls back some of the discounts…the past few years have been enormous for people with diabetes. Mostly because they’ve found each other.

Zoe Witt: I was rationing insulin in 2018, I didn’t even know that there was a term for it. I didn’t know other people were doing it. I know a lot of people died that year. And there were multiple occasions where I, in retrospect, definitely almost died. And the one good thing that has, that has happened between now and then is that people have been talking about it and People are now more comfortable telling others that they’re struggling, that they can’t get their insulin.

Emily: Connecting with Mutual Aid Diabetes or other networks to get or give help.

Zoe Witt: We’re all keeping each other alive, like to me, that’s the number one thing that has changed.

Emily: I think that’s a huge lesson here, and a takeaway that’s not new on this show. Keeping each other alive — or even just keeping each other from getting bankrupted by the medical system — is up to us. And while a mutual aid group modeled exactly like Mutual Aid Diabetes may not work for every disease or every drug, Zoe says they’re more than willing to talk to anyone who might be interested in trying.

Zoe Witt: I mean, we’ve even had people ask, like, is there like a mutual aid asthma or something like for inhalers? 

Emily: Their advice? 

Zoe Witt: I think that, you know, to start,  you would want, like,  probably at least, like, five to ten ”ride-or dies,” like, people that are really willing to, like, go the extra mile, 

Dan: Five to ten– that just does not sound like that many! (I mean, I think.) One thing I’m taking away is:  This is a lot of activism over a long time, that eventually had a big effect. Another thing I’m taking away here? Sneaky policy changes — like lifting the Medicaid rebate cap — can make a huge difference. God bless whatever nerds are writing the next little bit of law to sneak into a giant bill, like a hacker with a virus.

Emily: Totally. OK. I gotta take a shot, and eat my lunch.

Dan: Go for it. We’ll be back with a new episode in a few weeks. Till then, take care of yourself.

This episode of an arm and a leg was produced by Emily Pisacreta and me, Dan Weissman and edited by Ellen Weiss. 

Adam Raymonda is our audio wizard. Our music is by Dave Weiner and blue dot sessions. 

Gabrielle Healy is our managing editor for audience. She edits the first aid kit newsletter. 

Bea Bosco is our consulting director of operations. Sarah Ballama is our operations manager. 

And Arm and a Leg is produced in partnership with KFF Health News. That’s a national newsroom producing in depth journalism about healthcare in America and a core program at KFF, an independent source of health policy research, polling and journalism. 

Zach Dyer is senior audio producer at KFF Health News. He’s editorial liaison to this show. 

And thanks to the Institute for Nonprofit News for serving as our fiscal sponsor, allowing us to accept tax exempt donations. You can learn more about INN at INN. org. 

Finally, thanks to everybody who supports this show financially– you can join in any time at arm and a leg show dot com, slash, support — and thanks for listening.

“An Arm and a Leg” is a co-production of KFF Health News and Public Road Productions.

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