STAT

Opinion: STAT+: Clearing the patent thicket: A pathway to faster generic drug approvals

Revelations that AbbVie, the manufacturer of Humira, made more than $100 billion in extra profits by abusing the patent system to delay generic competition has spurred efforts by the Biden administration and Congress to limit the length of patent monopolies over prescription drugs.

Revelations that AbbVie, the manufacturer of Humira, made more than $100 billion in extra profits by abusing the patent system to delay generic competition has spurred efforts by the Biden administration and Congress to limit the length of patent monopolies over prescription drugs.

An executive order issued in July 2021 forced the Food and Drug Administration and the U.S. Patent and Trademark Office to join forces to finding ways to reduce the number of poor-quality patents that are granted. And the Senate’s Judiciary Committee reported out five bipartisan bills addressing competitive abuses that delay generic competition or otherwise lead to higher prescription drug prices.

Continue to STAT+ to read the full story…

2 years 4 months ago

First Opinion, Pharma, Advocacy, patents, Pharmaceuticals

STAT

STAT+: Dutch group sues AbbVie for human rights violations stemming from Humira pricing

A Dutch public interest group has filed a lawsuit claiming AbbVie breached a duty to human rights by using unfair and excessive pricing to bolster sales of its Humira drug and dominate the market at the expense of the health care system in the Netherlands.

In making its case, the Pharmaceutical Accountability Foundation argued AbbVie allegedly overcharged the Dutch health care system by up to $1.2 billion by “abusing” its position in the marketplace and keeping prices high. The company sold approximately $2.3 billion worth of Humira in the Netherlands between 2004 and 2018, when its patents provided a monopoly.

Continue to STAT+ to read the full story…

2 years 5 months ago

Pharma, Pharmalot, drug pricing, legal, patents, Pharmaceuticals

Kaiser Health News

The Kids Are Not OK

The Host

Julie Rovner
KHN


@jrovner


Read Julie's stories.

The Host

Julie Rovner
KHN


@jrovner


Read Julie's stories.

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.

Teen girls “are experiencing record high levels of violence, sadness, and suicide risk,” according to a new survey from the Centers for Disease Control and Prevention. In 2021, according to the survey, nearly 3 in 5 U.S. teen girls reported feeling “persistently sad or hopeless.”

Meanwhile, a conservative judge in Texas has delayed his ruling in a case that could ban a key drug used in medication abortion. A group of anti-abortion doctors is suing to challenge the FDA’s approval decades ago of the abortion pill mifepristone.

This week’s panelists are Julie Rovner of KHN, Alice Miranda Ollstein of Politico, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico, and Sandhya Raman of CQ Roll Call.

Panelists

Alice Miranda Ollstein
Politico


@AliceOllstein


Read Alice's stories

Joanne Kenen
Johns Hopkins Bloomberg School of Public Health and Politico


@JoanneKenen


Read Joanne's stories

Sandhya Raman
CQ Roll Call


@SandhyaWrites


Read Sandhya's stories

Among the takeaways from this week’s episode:

  • American teenagers reported record rates of sadness in 2021, with especially high levels of depression in girls and teens identifying as LGBTQ+, according to a startling CDC report. Sexual violence, mass shootings, cyberbullying, and climate change are among the intensifying problems plaguing young people.
  • New polling shows more Americans are dissatisfied with abortion policy than ever before, as a U.S. district court judge in Texas makes a last call for arguments on the fate of mifepristone. The case is undermining confidence in continued access to the drug, and many providers are discussing using only misoprostol for medication abortions. Misoprostol is used with mifepristone in the current two-drug regimen but is safe and effective, though slightly less so, when used on its own.
  • There are big holes in federal health privacy protections, and some companies that provide health care, like mental health services, exploit those loopholes to sell personal, identifying information about their customers. And this week, Republican Gov. Glenn Youngkin of Virginia blocked a state law that would have banned search warrants for data collected by menstrual tracking apps.
  • California plans to manufacture insulin, directly taking on high prices for the diabetes drug. While other states have expressed interest in following suit, it will likely be up to wealthy, populous California to prove the concept.

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

Julie Rovner: NPR’s “Is the Deadly Fungi Pandemic in ‘The Last of Us’ Actually Possible?” by Michaeleen Doucleff

Alice Ollstein: The New York Times’ “Childbirth Is Deadlier for Black Families Even When They’re Rich, Expansive Study Finds,” by Claire Cain Miller, Sarah Kliff, and Larry Buchanan; interactive produced by Larry Buchanan and Shannon Lin

Joanne Kenen: NPR’s “In Tennessee, a Medicaid Mix-Up Could Land You on a ‘Most Wanted’ List,” by Blake Farmer

Sandhya Raman: Bloomberg Businessweek’s “Zantac’s Maker Kept Quiet About Cancer Risks for 40 Years,” by Anna Edney, Susan Berfield, and Jef Feeley

Also mentioned in this week’s podcast:

Click to open the transcript

Transcript: The Kids Are Not OK

KHN’s ‘What the Health?’Episode Title: The Kids Are Not OKEpisode Number: 285Published: Feb. 16, 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’re taping this week on Thursday, Feb. 16, 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: Sandhya Raman of CQ Roll Call.

Sandhya Raman: Good morning.

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

Joanne Kenen: Hi, everybody.

Rovner: Later in this episode we’ll have the winner of KHN’s health policy valentines contest. I hope everyone had a pleasant Valentine’s Day with someone that you love. But first, this week’s health news. I’m calling our lede segment this week “The Kids Are Not OK,” and we’ll get to the gun violence stuff in a minute. First is news from the Centers for Disease Control and Prevention’s Youth Risk Behavior Survey. And let me just read from the press release, quote, “Nearly 3 in 5 — 57% — of U.S. teen girls felt persistently sad or hopeless in 2021, double that of boys representing a nearly 60% increase, and the highest level reported over the past decade.” According to the survey, teens who identify as LGBTQ+ have, quote, “ongoing and extreme distress. More than 1 in 5 of that group said they had attempted suicide in the year before the survey.” Now, clearly, 2021 was a bad year for most of us. The pandemic was still raging, but the political fights over things like vaccines and masking were raging, too. But these rates of mental health problems found by the biannual survey of high school students has gone up in every report since 2001. Why is this happening? What is wrong with our young people and what can we do to help?

Kenen: Well, whatever’s wrong with our young people is going to also be wrong with our old people. I mean, we create the world in which … I mean, I’m a mother and I’m an aunt and I’m an extended-family motherly person. There’s something about the world that we have created for our young people. Julie, we grew up in the Cold War. We grew up … we don’t remember the missile crisis and things like that. But we did grow up in an era of anxiety, existential threats. And yet, for our generation, it wasn’t as bad as it is for this generation. And in this generation, you look at kids who seem to be on top of the world, and they feel like the world is on top of them.

Rovner: Well, at least in my case, you couldn’t be bullied unless you were in person … which is not true anymore.

Kenen: But even 2000, 2001, it wasn’t. That’s not the only thing going on here. And it’s not only the pandemic. I mean, it’s lots of things.

Ollstein: What really jumped out to me in this data was the really high rates of rape and sexual violence. You know, the CDC has said that 1 in 5 teen girls have experienced sexual violence just in the past year, and more than 1 in 10 say they’ve been forced to have sex. This was grouped together with the mental health, depression, suicidal ideation data, indicating that these things are related. And so I think in order to pinpoint some factors, it really seems like … people don’t know how to relate to each other in a sexual way that’s healthy. I think a lot about the efforts to restrict education about sex and sexuality in schools and how that could potentially make this even worse.

Rovner: And remember, this is a survey of high school students. So these are younger young people, or at least early in their, you know, sexual awareness.

Kenen: Yeah, but there was assault and unwanted … there was ugly stuff in prior generations, tons of it. And it wasn’t … and in some ways it was more secretive and more shameful. I mean, I’m not saying it’s not a problem. It’s obviously a huge problem. Alice is right. But it’s not unique to this generation. It’s hard to measure because we weren’t looking for it. But it certainly wasn’t something that didn’t happen. But I think it was even more secretive in the past. So I agree with Alice, but I don’t think that’s all of it.

Rovner: Sandhya.

Ollstein: And you’re right that it’s hard to know for past generations.

Kenen: But they didn’t ask that question.

Ollstein: Since they’ve been asking, it’s gotten worse. They say it’s … sexual violence is up 20% since 2017. Rape is up 27% since 2019. So since they’ve been investigating this, it’s getting worse.

Raman: I would also add the cyberbullying element is a huge piece. You know, if we were looking at this maybe 20 years ago, that was not the same case. The amount of time that teens and young people spend online is much greater now, even within the data they looked at it — that cyberbullying was a lot higher for teens, for LGBTQ youth. And that has been a broad issue that, even this week in Congress, the Senate Judiciary Committee was looking at protecting kids online. And a huge element of that was cyberbullying. You heard from different parents who had lost a child due to excessive cyberbullying on a lot of these social media apps and due to suicide or other mental health issues. And I think that’s a huge piece of now versus, you know, several years ago.

Rovner: Yeah, I agree. Well, clearly, one factor in the declining mental well-being of high school students is the threat of being swept up in a mass shooting event. As if this week’s shooting at Michigan State University wasn’t awful enough, some of the students who had to shelter in place for hours in East Lansing were also survivors of the Oxford, Michigan, high school shooting in 2021. And there was even one student that we know of who was at Sandy Hook Elementary in 2012. Now, in college, there have been 71 mass shootings, defined as an incident in which four or more people are shot or killed, so far in 2023, according to the Gun Violence Archive, and it’s only the middle of February. And just in time, Gallup reports that 63% of Americans are dissatisfied with the nation’s gun laws. Up 7 percentage points from last year and the highest level in 23 years. Is there any way to get this any closer to the top of the issues for lawmakers to address? I mean, they got something tiny done last year, but it feels like the problem is just exploding.

Raman: No, I was going to say, even last year with the incremental stuff was really difficult to get across the board. And, even going back to the CDC data, there were survey results about how many kids are afraid to go to school right now. And that was one of the factors that was rising. And gun violence is obviously a factor in safety, especially for kids now. But I think on a federal level, getting something additional across the line, especially with this split Congress, is going to be really difficult. It might be more of a state-level thing. I think Michigan is already talking about doing something, but it might have to be more on that end than federal.

Ollstein: Yeah, absolutely. And not only with the divided Congress, but I think a lot of the champions of gun reform on the Republican side have since retired. I’m thinking of Sen. [Pat] Toomey, in particular. And so not only do you have a House-Senate divide, but you don’t have some of the voices on the right calling for this that you’re used to.

Rovner: Yeah, the sides seem to be retreating to the poles, as usual, and the public is not happy about it.

Kenen: Well, one last thing, Julie, really quickly. I mean, I think young people today are very aware of climate as an existential threat, which was not true of prior generations.

Rovner: Yes.

Kenen: And I think kids have this real profound fear. And I think that feeds into the anxiety part of it. At least, you know, they just …

Rovner: Yeah, I think that’s absolutely true. And that’s something that’s been ratcheting up over the past several years as we’ve seen this mental well-being …

Kenen: The pace of damage to the Earth is faster than the scientists had projected.

Rovner: All right. Well, now we’re going to turn to abortion, which is another place where the public is not happy with how it’s being regulated. Yet a different Gallup poll finds Americans more dissatisfied with U.S. abortion policy than any time in 23 years, with a record 69% of adults reporting dissatisfaction. That includes 46% who want less strict laws and only 14% who say they want more restrictions. Yet the political energy seems like it’s with the anti-abortion side, or am I misreading that?

Ollstein: I think there’s a lot of activity on both sides. I mean, Sandhya mentioned Michigan, and I think that’s a spot — along with Minnesota, where Democrats really won big in this past election and want to use their new state-level power to advance some abortion rights measures. But I think you’re seeing a lot more on the “anti-” side, and you’re seeing a lot more splits within the anti-abortion side over how to restrict abortion, how far to go, what kind of exemptions to include, if any. And so you’re seeing a lot more debate, whereas the left, who wants to protect abortion rights, seems a little bit more unified on what they want to do right now. And then, like guns, the federal level is pretty stalemate, roadblock. Nothing much is going to happen there.

Rovner: But also, I think it’s that, you know — and I’m as guilty of this as anybody — that the journalists would rather cover squabbles than people who are actually together. So maybe it’s getting a little more ink. Well, it continues to look like a single federal judge in Texas might well try to ban the abortion pill. mifepristone nationwide. Trump appointee Matthew Kaczmarek did not rule as expected last week in a case charging FDA with wrongly approving the drug 22 years ago. Rather, the judge gave the parties two more weeks to submit briefs, which seems to have prompted every party with the least bit of interest in this case to file amicus briefs. I have never seen anything like this at the federal district court level. It looks like a major Supreme Court case, but it’s not. Has anybody else seen anything like this? I mean, this case seems to be taking on as much importance as your average big Supreme Court case.

Ollstein: It very well could be a Supreme Court case in the future. And I think that’s reflected there, too. And I also want to note that part of the reason for the couple of weeks of delay the judge ordered was to allow the drugmaker to have time to submit arguments because the drugmaker, Danco [Laboratories], says that the different parties in the suit, even the FDA, aren’t really representing their interests and they want to argue for the right to market their product. So that’s pretty interesting. But then, yeah, you have the attorneys general, Democrats, and Republicans lining up on either side of the case. The Republican attorneys general saying, “We support banning this medication nationwide” and the Democratic attorneys general saying, “No, let’s trust the FDA and their scientific process to approve this drug.”

Kenen: I mean, I think there’s sort of a significance in how it’s described because you can say, well, Congress gave the FDA the power to approve drugs. But the anti-abortion movement does not call this a medication abortion. They call it chemical abortion. And therefore, they’re treating this not as a drug but as a lethal chemical. You know, whether the judge goes along with that thinking … we know he’s a strongly anti-abortion judge. There’s no question. And there’s a widespread anticipation that he is going to rule with the anti-abortion side. But we never know what a judge is going to do until a judge does it. And Alice has covered this much more closely than I have, so she’ll probably want to weigh in more. But the issue is, is he going to think that the court should overrule the FDA or is he going to think this is a, quote, “chemical,” not a, quote “medication,” and therefore that the FDA is irrelevant? And I mean, Alice, you can give a better restatement of what I just said since you’ve written about it.

Rovner: I want to respond to Alice’s earlier point about the drug company wanting to get involved, because the big question here, not to get into too much legal minutiae, is why did the people who are suing have standing to sue? They have not been injured by the ability to sell this drug for 22 years. No one’s making them buy it. Arguably, the only party that has standing is the drug company, because if it was cut off, they would lose money. They have an obvious injury here. So the legal niceties of this may not go together either. Alice, do you want to do a follow-up?

Ollstein: Yeah, I mean, to go to the standing issue, the people challenging the FDA approval here are conservative doctors who say that they’ve had to do follow-up treatment for patients who’ve taken the abortion pill and then need follow-up treatment, and that takes their time and attention away from treating other patients. I mean, doctors treating a patient, that’s kind of their job. So I think there’s definitely a question on harm and standing there. Just a couple of thoughts on the case. Abortion rights groups both say that this could be an absolute crisis, disaster across the country. But then they also point out that people will still be able to have medication abortions because the two-pill regimen that’s been used for 20 years, it can still work with just the second pill. So this case is about banning the first pill. The different providers who have spoken out say we’re preparing to just provide abortions via the second pill, if needed.

Rovner: And that second pill, misoprostol, is not going to be pulled off the market. It’s used for many, many things. It just happens it also can end a pregnancy.

Ollstein: Exactly. Way harder to ban. And that’s one thing. Medication abortions will still continue if the judge rules how people expect him to. You know, another thing with all the amicus briefs and the drug company intervening as people are bringing up, if we allow someone to come in 20 years after the fact and challenge FDA approval of something, doesn’t that open Pandora’s box to people challenging all kinds of things, I mean, vaccines and whatnot? And won’t that cause chaos and not make drug companies feel like they can trust the process and have confidence in bringing drugs to market in the U.S.? So that’s another piece of the puzzle as well.

Raman: I would add that there’s already a little bit of chaos because, you know, whatever ruling we have, likely later this month, is almost definitely going to be appealed and then probably appeals again. So it’s going … we could have a back-and-forth process where providers might go one way and then the other. And then, in the contingency stuff they’ve been doing, piggybacking on what Alice was saying, is that if they do this misoprostol regimen, it’s not as straightforward as the two-dose that you’re used to in that there are different amounts of dosage, you might have to do repeated dosages. It’s not as simple, even if that’s done in a lot of other parts of the world. And then some providers have said that they would also just switch to doing all surgical abortions. But that also is more timely. You’d have to do the whole thing in clinic rather than send someone home with the pill. And then that is going to take longer. You’re going to schedule fewer patients. There’s already that many different contingency plans that these clinics are going to have to do regardless of what we hear down the line and through the appeals process.

Rovner: We already know that clinics are backed up from women coming from other states. So patients are having to wait longer to get abortions. And, you know, as … it gets further along, you have to do different procedures that are more expensive. It’s already piling up in different places. Well, speaking of some other different places, we’re seeing a lot of national pro- and anti-abortion groups getting involved in a Wisconsin Supreme Court election, of all things. What is up with that?

Ollstein: Well, that could decide the fate of abortion access in that state. You know, you have the split of a Democratic governor and a Republican legislature. So things really could come down. You know, the state had a pre-Roe ban that went into effect. So things are expected to come down to the makeup of the Supreme Court. And so you’re having just tons of outside money being poured into this race for that reason and really putting a spotlight on how much power are these state supreme courts have. And it’s true in other states as well. And there are many cases pending in different states. You know, I’ve been following the Kentucky one, in particular, but there are a bunch of different cases pending before a state supreme court that could really re-legalize or maintain the ban on abortion.

Kenen: There are also election issues and, on abortion, in the state of Wisconsin, election rules, election certification issues that it’s one of the three or four states where that’s really a hot potato. And that’s another reason this race is getting so much attention. I mean, it’s the state Supreme Court race that’s getting a huge amount of national attention and national money. So there are several issues I would agree with Alice on. The No. 1 is probably abortion. But it’s not only abortion.

Raman: And it’s interesting because this is the first time that EMILY’s List has endorsed ever a state Supreme Court race. And I think another thing to consider is that, you know, this is still considered a nonpartisan race since it’s a court seat. I mean …

Rovner: In theory.

Raman: In theory, yes. Even though all of these groups are looking at the histories of how people have ruled in the past. But I think that’s another thing that makes it a little bit more interesting given it’s not strictly a Democrat or Republican endorsement, like a lot of the other things that we’ve been following.

Rovner: Yes. And I saw on the other side the Susan B Anthony List, the anti-abortion group, said … put out a press release this week saying they’re going to have six-figure spending in Wisconsin on this race. So …

Kenen: It’ll be very good for the Wisconsin economy.

Rovner: It will be very good for the Wisconsin economy. Well, anti-abortion lawmakers are busy in a bunch of states pursuing another new trend, giving tax breaks to so-called crisis pregnancy centers that, at least when abortion was legal, lured pregnant women in by pretending to be an abortion clinic and then trying to convince them not to terminate their pregnancies. Missouri has already allowed donors to these crisis pregnancy centers to write off contributions on their state taxes. Now, Kansas, Arkansas, and Oklahoma are considering similar programs, but Kansas is the only one of those states where abortion is still legal. What are CPCs going to do now that they can’t pose as abortion facilities?

Raman: I think there’s still a lot of confusion for folks. I mean, given how a lot of these laws have been changing back and forth. I mean, even as folks that follow this very closely, there’s so many different things where someone … I think we’ve looked at polling before where people don’t always know: Is abortion illegal or not legal in our state? Or at what point? It’s difficult to keep track of, with so many changes going back and forth. So I think that there could feasibly still be people who might be looking for an abortion that don’t understand or — we’ve seen that a lot of these clinics have also bought a lot of ads so that you might be searching for an abortion and you get redirected to one of these clinics. So I think there’s still overlap in folks that might be searching for one and end up at another.

Kenen: I don’t know how much online presence they have, because that could be across state lines. You know, if someone’s on or near a border, there’s all sorts of … people might think that surgical abortions are legal, but medication is not, or that they can or someone could help them order pills. You can never underestimate how confused Americans are about any number of things. So … but they also might …

Rovner: This is confusing, to be fair.

Kenen: Yes. But they also might concentrate their efforts less on the no-abortion states and move more to the abortion states. Or they may advertise in ways that captures or attempts to capture people who are looking to go out of state or to get a cross-state-line prescription, whatever. They can promote themselves in different ways. Or they may also just decide to not do as much in Texas and do a lot more in upstate New York. I mean, I don’t know how they’re going to totally respond to the legal landscape either.

Ollstein: Yeah. And they’ve also become sort of a legal force of their own. I know they’re involved in challenging some of California’s pro-abortion rights policies. The CDC is specifically. So they also have … are trying to play a role on that front, in addition to direct patients’ interface or however we want to phrase it.

Rovner: All right. Well, while we’re talking about patients’ privacy, I want to talk about data. First, a kind of terrifying story from The Washington Post this week details how data brokers have been selling the names and addresses of people with depression, anxiety, and other mental health disorders so they can be advertised to. A lot of this has come from people using mental health apps or websites that are not covered by the HIPAA privacy rules because they are not technically covered health entities. A separate story this week notes how Virginia Gov. Glenn Youngkin helped defeat a bill in the Virginia legislature to provide legal protections to women’s menstrual data contained in period tracking apps. A Virginia official who was opposing the bill said it would put limits on search warrants, which could lead to other problems down the road. One researcher described the privacy practices of the vast majority of mental health apps as, quote, “exceptionally creepy.” How concerned should we be about all of this?

Kenen: I found that really horrifying. And a family friend who had been looking for a therapist and I said, well, maybe — and they were having trouble finding somebody in network and it’s very expensive — and I said, “Well, maybe you should look into some of the online ones that do take insurance.” And after reading that, I told that person, “I’m not so sure that it’s a good idea.” And we do have a shortage of mental health providers in this country. We have an even greater shortage of mental health providers that take insurance. There’s been a lot of talk about how telemedicine for mental health is at least part of the answer. But this should really raise … because they’re not just selling de-identified data. Some of them in that article were selling people’s names, address, diagnosis, and medical history. If it was truly, truly, truly de-identified, it’s different then. And that can be used for research. But a lot of what’s so-called de-identified isn’t de-identified. And this doesn’t even pretend to be. This is, like, search, and you can find out who the person is, an awful lot of intimate detail about their lives. So unless there’s some real safeguards, would you want any of your medical data with your name on it being sold? No. It is. It is being. But …

Rovner: When the HIPAA rules first went into effect, which was around the year 2000, actually  it took a few years — researchers came to Capitol Hill screaming because they were afraid they weren’t going to be able to get any of this de-identified data and they weren’t going to be able to continue to do research. Now, we seem to have gone far in the other direction. And I know that there are efforts on Capitol Hill to do things to update the women’s reproductive information, keeping that private. Anybody think that they might get into an expansion of HIPAA? I mean, that’s really all it would take would be to create more covered entities.

Raman: Yeah, it isn’t as much about the expansion of HIPAA, but there have definitely been pretty concerted efforts to get … the U.S. doesn’t have a comprehensive data privacy law. You know, in contrast to, like, the EU or something. And that has been a big effort for the lawmakers that are focused on tech policy for a while. Even the hearing earlier this week with Senate Judiciary, they brought up several bills. And the issue has been that all of these issues are bipartisan, folks are on board. It’s just not enough people are on board, and little things that have been getting in the way there. And so that has been an issue. And I think even during that hearing, we had one researcher bring up different sites — like NEDA, which is mentioned in some of these lawsuits by some of the hospitals — have been collecting all of this data. But then they, as researchers, are not able to get access to that data, and that would be extremely beneficial for them to be able to say this is what the impact of some of these things are on kids. So it’s a Catch-22 where it’s, like, OK a) we’re not having the research be able to get the data, b) we’re having it sold in a malicious way and c) we haven’t been able to find a solution to mitigate all of this.

Kenen: Yeah, I don’t know about the prospects for a gigantic tech bill because it has many components and they’re controversial and hard to get 60 votes for. But I think there’s a difference between selling stuff about who bought shoes versus someone who is on an anti-psychotic or an antidepressant or whatever, or getting marital counseling, whatever. I mean, these are not the same issue as the whole constellation of tech issues. I can see this being something bipartisan. HIPAA has been updated a little bit, but the fundamental HIPAA law dates back to what, ’96, Julie? … I think that’s when it was.

Rovner: Yeah, although …

Kenen: It has been updated, but it hasn’t been overhauled to really fit the cyber universe we live in.

Rovner: But also Congress never really did HIPAA. People don’t remember this: The 1996 law basically had a provision that said Congress needs to fundamentally address privacy if we’re going to move more towards digital health records, which at the time was starting to happen. And if they don’t, then the secretary of Health and Human Services is authorized to put out regs. And guess what? Congress didn’t do it. So the HIPAA regs that we have now were put out at the end of the Clinton administration. Congress was never able to come together on this. So now things have obviously gotten worse.

Kenen: Yes. And since the Supreme Court now doesn’t like agencies regulating that, that seems to create an entire new existential question. But do I think that medical privacy is something that you could find some kind of bipartisan lanes on? I don’t think a lot of bipartisan things are going to happen in the next two years. This does seem to be one of the few areas that is not a red-blue ideological issue. And I can see Republicans and Democrats being horrified by some of this and maybe not totally sealing it up, but putting … better guardrails on what can be brokered.

Raman: One of the issues has been, I think even in the past, was that California is the one state that has implemented a few layers of very intense data privacy laws. And so, you know, when you have people in leadership that are in from California and it’s hard to get some of those compromises across when it might be more watered down than something California has and take precedent being federal. So it’s one of the many layers of why it’s been difficult over the past year to get any of this stuff done.

Rovner: Well, we should note that the Biden administration is actually working on some enforcement. Earlier this month, the Federal Trade Commission fined the prescription drug discounter GoodRx $1.5 million for illegally sharing customer’s personal health information. It was the very first enforcement action under a 2009 law that applies to health record vendors and others not covered by HIPAA. So at least there’s one avenue where this could be pursued. I imagine we’ll be seeing more of that if not, you know, whether or not they can reach all of these things seems unlikely.

Kenen: Yeah, doing it piecemeal does not seem to be the approach, and I’m not even sure how much $1.5 million is for GoodRx. I don’t think that’s a lot of money for any major pharmaceutical entity.

Rovner: No. And there are a lot of people who use it. All right. Well, finally this week, while we’re talking about drugs, I’ve been trying to get to this for a while. California has — speaking of California, things that other states haven’t done — California has decided to try to limit the cost of insulin for people with diabetes by manufacturing it itself. Could this set a precedent to really disrupt the insulin market, or is California just so big and wealthy that it’s basically the only state that could do something like this — or only state they would do something like this?

Ollstein: So I will note that Gov. [Gretchen] Whitmer in Michigan has also proposed state manufacturing of insulin. So California might not be the only one. I think the idea is that insulin is pretty cheap to manufacture. It’s become the poster child for out-of-control drug prices for that reason — the disparity between what it costs for patients and what it costs to make is so vast. And so I think you are likely to have a few states. But I think it will take a state doing it successfully to get a significant number of others to follow.

Rovner: I think there might be a thought that because California is so big, it could disrupt the market elsewhere — I mean, in the country. That strikes me as a reach. But it’s, you know, Congress, again — talking about things that Congress can’t do — they managed to limit insulin prices for people on Medicare, but not even for everybody else.

Kenen: There was also a good piece in The Atlantic, maybe two or three months ago, that some of these new diabetic drugs, which are injectables and very expensive, mean you don’t need insulin. So … but by addressing making insulin really cheap, which is a good … I mean so people who are on insulin and need insulin … but there are some people who actually could take one of these other drugs and then they wouldn’t be able to afford these other drugs, which might be better for them. And then they’ll end up on cheap insulin. So it’s always more complicated than it sounds. And I also think there’s different kinds of insulin. Someone else on the panel might, you know, that I’m not sure that …

Rovner: There are lots of different formulations.

Kenen: There are two major kinds of diabetes, obviously, Type 1 and Type 2. And then there’s different patients with different degrees of … you know, how far their other health conditions is advanced, etc., etc. So cheap insulin is not even a solution for diabetes. It’s one part of a solution for one of many chronic diseases in America.

Rovner: Well, we will never not have enough things to talk about. 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. Joanne, why don’t you kick us off this week?

Kenen: Yes. This was a collaboration between NPR, Nashville Public Radio, and Kaiser Health News, aired on NPR by Blake Farmer. “In Tennessee, a Medicaid Mix-Up Could Land You on a ‘Most Wanted’ List.” And basically, Tennessee is cracking down on Medicaid fraud. Most Medicaid fraud is actually from doctors and other health care providers — there have been a bunch of home health scandals and so forth. The amount of fraud and the amount of money involved in patient fraud is small, and yet they’re spending a huge amount of money to try to capture a small amount of fraud. And there are huge mistakes. Like the person in this article was just … she was entitled to Medicaid. She did nothing wrong. But they publicly … like, they don’t even wait for you to be convicted. They’re publishing …  they’re making public the charge. This woman turned out to be … it had to do with an old address on … an expired driver’s license that got the system confused. She was doing nothing wrong, and yet she was completely blacklisted, employment and everything else because she was accused of being a felon in publicly available databases. So, a) are they looking in the right place for fraud? And b) are they protecting people’s rights? Clearly the latter they are not because they were publishing … people were accused but not convicted, and then they weren’t removing it in a timely, effective way. So this woman is, like, unemployable. She can’t rent an apartment, and she did nothing wrong. So there’s a whole series of abuses in this story. Not that Medicaid fraud is a good thing. Medicaid fraud is a bad thing, but this is not the way to go after it.

Rovner: This was one in a series of horrifying stories this week. Alice, you have another horrifying story.

Ollstein: Yes. Although this is under the banner of more evidence to bolster the upsetting things that we sort of already knew. This is a really good piece from The New York Times, laying out a lot of data to show that there is these differences in maternal mortality between Black and white women that can’t be attributed to income, showing that even wealthier Black women still face much worse outcomes. And so they say, you know, even when you account for income, even when you account for education and a lot of other factors, there are still these impacts of structural racism in the health system that continue to put Black mothers more in danger. And so this is coming at a time when there’s a lot of focus on this. But there has been sort of a lot of focus on the income, socioeconomic side and people recommending that states expand postpartum coverage of Medicaid. And that certainly is recommended, and experts think that would help. But this shows that it won’t completely solve the problem and there are other factors to address.

Kenen: And it’s not just in maternal mortality. I mean, the racial disparities in health care are not just income-related.

Rovner: And finally, Sandhya, you have a story from one of our fellow podcast panelists.

Raman: Yeah, the story I picked is “Zantac’s Maker Kept Quiet About Cancer Risks for 40 Years,” and that’s at Bloomberg News from Anna Edney, Susan Berfield, and Jef Feeley. And this was a really great story about Zantac, the heartburn and reflux drug that was once one of the world’s best-selling prescription medications. And then in 2020, it was pulled off the U.S. market over cancer risks. And the article goes through how since its beginnings, Glaxo’s own scientists, the drugmaker, had warned that it could be dangerous, but proving some of this has been a little difficult. … But the story goes through some of the documents that show that Glaxo chose not to look into this, even though the leading health agencies — EPA, FDA, WHO — all say NDMA is a carcinogen.

Rovner: Yeah, it’s quite the investigation. Well worth reading. Well, my story is a little less horrifying than everybody else’s. It’s from my former NPR Science Desk colleague Michaeleen Doucleff and it’s called “Is the Deadly Fungi Pandemic in ‘The Last of Us’ Actually Possible?” And I will cut to the chase. The answer is most almost certainly no. But that’s not to say we shouldn’t be worried about fungi and fungal diseases, particularly as the Earth continues to warm, which is what touches off the pandemic in the video game/HBO miniseries that’s airing now. There are new fungal diseases that can be pretty nasty, too, but zombies, almost certainly not. Well, maybe, certainly not. Anyway, listen to or read Michaeleen’s story. Before we go, this week was Valentine’s Day and, as promised, we have the winner of KHN’s best health policy valentine, as chosen by our editors and social media staff. This year’s winner is Jennifer Goldberg, and it goes as follows: “Roses are red, candy is sweet. Adding #Dental to #Medicare makes it more complete!” Congrats to Jennifer and thanks everyone for your creative health policy valentines.

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. As always, you can email us your comments or questions. We’re at whatthehealth — all one word — @kff.org. Or you can tweet me. I’m @jrovner. Joanne?

Kenen: @JoanneKenen

Rovner: Sandhya?

Raman: @SandhyaWrites

Rovner: Alice.

Ollstein: @AliceOllstein

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

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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.

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2 years 5 months ago

Mental Health, Multimedia, Pharmaceuticals, Abortion, Children's Health, Drug Costs, Health IT, KHN's 'What The Health?', Podcasts

Kaiser Health News

Alarmante desafío de salud: venden opioides mezclados con tranquizilantes para animales en barrio de Philadelphia

Muchas personas del barrio de Kensington, en Philadelphia —el mayor mercado abierto de drogas al aire libre de la costa este— son adictas y aspiran, fuman o se inyectan al aire libre, encorvadas sobre cajas o en los escalones de las casas. A veces es difícil saber si están vivos o muertos. Las jeringuillas ensucian las aceras y el hedor de la orina inunda el aire.

Las aflicciones del barrio se remontan a principios de los años 70, cuando la industria desapareció y el tráfico de drogas se afianzó. Con cada nueva oleada de drogas, la situación se agrava. Ahora está peor que nunca. Ahora, con la llegada de la xilacina, un tranquilizante de uso veterinario, nuevas complicaciones están sobrecargando un sistema ya desbordado.

“Hay que poner manos a la obra”, dijo Dave Malloy, un veterano trabajador social de Philadelphia que trabaja en Kensington y otros lugares de la ciudad.

Los traficantes utilizan xilacina, un sedante barato no autorizado, para cortar el fentanilo, un opioide sintético 50 veces más potente que la heroína. El nombre callejero de la xilacina es “tranq”, y el fentanilo cortado con xilacina se llama “tranq dope”.

La xilacina lleva una década diseminándose por el país, según la Agencia Antidroga (DEA). Su aparición ha seguido la ruta del fentanilo: empezando en los mercados de heroína en polvo blanco del noreste y desplazándose después hacia el sur y el oeste.

Además, ha demostrado ser fácil de fabricar, vender y transportar en grandes cantidades para los narcotraficantes extranjeros, que acaban introduciéndola en Estados Unidos, donde circula a menudo en paquetes de correo exprés.

La xilacina se detectó por primera vez en Philadelphia en 2006. En 2021 se encontró en el 90% de las muestras de opioides callejeros. En ese año, el 44% de todas las muertes por sobredosis no intencionales relacionadas con el fentanilo incluyeron xilacina, según estadísticas de la ciudad. Dado que los procedimientos de análisis durante las autopsias varían mucho de un estado a otro, no hay datos exhaustivos sobre las muertes por sobredosis con xilacina a nivel nacional, según la DEA.

Aquí en Kensington, los resultados están a la vista. Usuarios demacrados caminan por las calles con heridas necróticas en piernas, brazos y manos, que a veces llegan al hueso.

La vasoconstricción que provoca la xilacina y las condiciones antihigiénicas dificultan la cicatrización de cualquier herida, y mucho más de las úlceras graves provocadas por la xilacina, explicó Silvana Mazzella, directora ejecutiva de Prevention Point Philadelphia, un grupo que ofrece servicios conocidos como “reducción del daño”.  

Stephanie Klipp, enfermera que se dedica al cuidado de heridas y a la reducción de daños en Kensington, dijo que ha visto a personas “viviendo literalmente con lo que les queda de sus extremidades, con lo que obviamente debería ser amputado”.

El papel que desempeña la xilacina en las sobredosis mortales pone de relieve uno de sus atributos más complicados. Al ser un depresor del sistema nervioso central, la naloxona no funciona cuando se trata de un sedante.

Aunque la naloxona puede revertir el opioide de una sobredosis de “tranq dope”, alguien debe iniciar la respiración artificial hasta que lleguen los servicios de emergencia o la persona consiga llegar a un hospital, cosa que a menudo no ocurre. “Tenemos que mantener a las personas con vida el tiempo suficiente para tratarlas, y eso aquí es diferente cada día”, explicó Klipp.

Si un paciente llega al hospital, el siguiente paso es tratar el síndrome de abstinencia agudo de “tranq dope”, que es algo delicado. Apenas existen estudios sobre cómo actúa la xilacina en humanos.

Melanie Beddis vivió con su adicción dentro y fuera de las calles de Kensington durante unos cinco años. Recuerda el ciclo de desintoxicación de la heroína. Fue horrible, pero después de unos tres días de dolores, escalofríos y vómitos, podía “retener la comida y posiblemente dormir”. Con la “tranq dope” fue peor. Cuando intentó dejar esa mezcla en la cárcel, no pudo comer ni dormir durante unas tres semanas.

Las personas que se desintoxican de la “tranq dope” necesitan más medicamentos, explicó Beddis, ahora en recuperación, quien ahora es directora de programas de Savage Sisters Recovery, que ofrece alojamiento, asistencia y reducción de daños en Kensington.

“Necesitamos una receta que sea eficaz”, señaló Jeanmarie Perrone, médica y directora fundadora del Centro de Medicina de Adicciones de Penn Medicine.

Perrone dijo que primero trata la abstinencia de opioides, y luego, si un paciente sigue experimentando malestar, a menudo utiliza clonidina, un medicamento para la presión arterial que también funciona para la ansiedad. Otros médicos han probado distintos fármacos, como la gabapentina, un medicamento anticonvulsivo, o la metadona.

“Es necesario que haya más diálogo sobre lo que funciona y lo que no, y que se ajuste en tiempo real”, afirmó Malloy.

Philadelphia ha anunciado recientemente que va a poner en marcha un servicio móvil de atención de heridas como parte de su plan de gastos de los fondos del acuerdo sobre opioides, con la esperanza de que esto ayude al problema de la xilacina.

Lo mejor que pueden hacer los especialistas en las calles es limpiar y vendar las úlceras, proporcionar suministros, aconsejar a la gente que no se inyecte en las heridas y recomendar tratamiento en centros médicos, explicó Klipp, que no cree que un hospital pueda ofrecer a sus pacientes un tratamiento adecuado contra el dolor. Muchas personas no pueden quebrar el ciclo de la adicción y no hacen seguimiento.

Mientras que la heroína solía dar un margen de 6-8 horas antes de necesitar otra dosis, la “tranq dope” solo da 3-4 horas, estimó Malloy. “Es la principal causa de que la gente no reciba la atención médica adecuada”, añadió. “No pueden estar el tiempo suficiente en urgencias”.

Además, aunque las úlceras resultantes suelen ser muy dolorosas, los médicos son reacios a dar a los usuarios analgésicos fuertes. “Muchos médicos ven eso como que buscan medicación en lugar de lo que está pasando la gente”, dijo Beddis.

Por su parte, Jerry Daley, director ejecutivo de la sección local de un programa de subvenciones gestionado por la Oficina de Política Nacional de Control de Drogas (ONDCP), dijo que los funcionarios de salud y las fuerzas del orden deben comenzar a tomar medidas enérgicas contra la cadena de suministro de xilacina y transmitir el mensaje de que las empresas deshonestas que la fabrican están “literalmente beneficiándose de la vida y las extremidades de las personas”.

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.

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2 years 5 months ago

Noticias En Español, Pharmaceuticals, Public Health, Disparities, Homeless, Opioids, Pennsylvania, Prescription Drugs

Kaiser Health News

As Opioids Mixed With Animal Tranquilizers Arrive in Kensington, So Do Alarming Health Challenges

Many people living on the streets in Philadelphia’s Kensington neighborhood — the largest open-air drug market on the East Coast — are in full-blown addiction, openly snorting, smoking, or injecting illicit drugs, hunched over crates or on stoops. Syringes litter sidewalks, and the stench of urine fouls the air.

The neighborhood’s afflictions date to the early 1970s, when industry left and the drug trade took hold. With each new wave of drugs, the situation grows grimmer. Now, with the arrival of xylazine, a veterinary tranquilizer, new complications are burdening an already overtaxed system.

“It’s all hands on deck,” said Dave Malloy, a longtime Philadelphia social worker who does mobile outreach in Kensington and around the city.

Dealers are using xylazine, which is uncontrolled by the federal government and cheap, to cut fentanyl, a synthetic opioid up to 50 times stronger than heroin. The street name for xylazine is “tranq,” and fentanyl cut with xylazine is “tranq dope.” Mixed with the narcotic, xylazine amplifies and extends the high of fentanyl or heroin.

But it also has dire health effects: It leaves users with unhealing necrotic ulcers, because xylazine restricts blood flow through skin tissue. Also, since xylazine is a sedative rather than a narcotic, overdoses of tranq dope do not respond as well to the usual antidote — naloxone — which reverses the effects of only the latter.

Xylazine has been spreading across the country for at least a decade, according to the Drug Enforcement Administration, starting in the Northeast and then moving south and west. Plus, it has proven to be easy for offshore bad actors to manufacture, sell, and ship in large quantities, eventually getting it into the U.S., where it often circulates by express delivery.

First detected in Philadelphia in 2006, xylazine was found in 90% of street opioid samples in the city by 2021. That year, 44% of all unintentional fentanyl-related overdose deaths involved xylazine, city statistics show. Since testing procedures during postmortems vary widely from state to state, no comprehensive data for xylazine-positive overdose deaths nationally exists, according to the DEA.

Here in Kensington, the results are on display. Emaciated users walk the streets with necrotic wounds on their legs, arms, and hands, sometimes reaching the bone.

Efforts to treat these ulcers are complicated by the narrowing of blood vessels that xylazine causes as well as dehydration and the unhygienic living conditions that many users experience while living homeless, said Silvana Mazzella, associate executive officer of the public health nonprofit Prevention Point Philadelphia, a group that provides services known as harm reduction.

Stephanie Klipp, a nurse who does wound care and is active in harm reduction efforts in Kensington, said she has seen people “literally living with what’s left of their limbs — with what obviously should be amputated.”

Fatal overdoses are rising because of xylazine’s resistance to naloxone. When breathing is suppressed by a sedative, the treatment is CPR and transfer to a hospital to be put on a ventilator. “We have to keep people alive long enough to treat them, and that looks different every day here,” Klipp said.

If a patient reaches the hospital, the focus becomes managing acute withdrawal from tranq dope, which is dicey. Little to no research exists on how xylazine acts in humans.

Melanie Beddis lived with her addiction on and off the streets in Kensington for about five years. She remembers the cycle of detoxing from heroin cold turkey. It was awful, but usually, after about three days of aches, chills, and vomiting, she could “hold down food and possibly sleep.” Tranq dope upped that ante, said Beddis, now director of programs for Savage Sisters Recovery, which offers housing, outreach, and harm reduction in Kensington.

She recalled that when she tried to kick this mix in jail, she couldn’t eat or sleep for about three weeks.

There is no clear formula for what works to aid detoxing from opiates mixed with xylazine.

“We do need a recipe that’s effective,” said Dr. Jeanmarie Perrone, founding director of the Penn Medicine Center for Addiction Medicine and Policy.

Perrone said she treats opioid withdrawal first, and then, if a patient is still uncomfortable, she often uses clonidine, a blood pressure medication that also lessens anxiety. Other doctors have tried gabapentin, an anticonvulsant medication sometimes used for anxiety.

Methadone, a medication for opioid use disorder, which blunts the effects of opioids and can be used for pain management, seems to help people in tranq dope withdrawal, too.

In the hospital, after stabilizing a patient, caring for xylazine wounds may take priority. This can range from cleaning, or debridement, to antibiotic treatment — sometimes intravenously for periods as long as weeks — to amputation.

Philadelphia recently announced it is launching mobile wound care as part of its spending plan for opioid settlement funds, hopeful that this will help the xylazine problem.

The best wound care that specialists on the street can do is clean and bandage ulcers, provide supplies, advise people not to inject into wounds, and recommend treatment in medical settings, said Klipp. But many people are lost in the cycle of addiction and don’t follow through.

While heroin has a six- to eight-hour window before the user needs another hit, tranq dope wanes in just three or four, Malloy estimated. “It’s the main driver why people don’t get the proper medical care,” he said. “They can’t sit long enough in the ER.”

Also, while the resulting ulcers are typically severely painful, doctors are reluctant to give users strong pain meds. “A lot of docs see that as med-seeking rather than what people are going through,” Beddis said.

In the meantime, Jerry Daley, executive director of the local chapter of a grant program run by the Office of National Drug Control Policy, said health officials and law enforcement need to start cracking down on the xylazine supply chain and driving home the message that rogue companies that make xylazine are “literally profiting off of people’s life and limb.”

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.

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2 years 5 months ago

Pharmaceuticals, Public Health, Disparities, Homeless, Opioids, Pennsylvania, Prescription Drugs

Kaiser Health News

A Health-Heavy State of the Union

The Host

Julie Rovner
KHN


@jrovner


Read Julie's stories.

The Host

Julie Rovner
KHN


@jrovner


Read Julie's stories.

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.

Health care was a recurring theme throughout President Joe Biden’s 2023 State of the Union address on Capitol Hill this week. He took a victory lap on recent accomplishments like capping prescription drug costs for seniors on Medicare. He urged Congress to do more, including making permanent the boosted insurance premium subsidies added to the Affordable Care Act during the pandemic. And he sparred with Republicans in the audience — who jeered and called him a liar — over GOP proposals that would cut Medicare and Social Security.

Meanwhile, abortion rights advocates and opponents are anxiously awaiting a federal court decision out of Texas that could result in a nationwide ban on mifepristone, one of two drugs used in medication abortion.

This week’s panelists are Julie Rovner of KHN, Alice Miranda Ollstein of Politico, Rachel Cohrs of Stat, and Sarah Karlin-Smith of the Pink Sheet.

Panelists

Rachel Cohrs
Stat News


@rachelcohrs


Read Rachel's stories

Sarah Karlin-Smith
Pink Sheet


@SarahKarlin


Read Sarah's stories

Alice Miranda Ollstein
Politico


@AliceOllstein


Read Alice's stories

Among the takeaways from this week’s episode:

  • President Joe Biden’s State of the Union address emphasized recent victories against high health care costs, like Medicare coverage caps on insulin and out-of-pocket caps on prescription drug spending. Biden’s lively, informal exchange with lawmakers over potential cuts to Medicare and Social Security seemed to steal the show, though the political fight over cutting costs in those entitlement programs is rooted in a key question: What constitutes a “cut”?
  • Biden’s calls for bipartisanship to extend health programs like pandemic-era subsidies for Affordable Care Act health plans are expected to clash with conservative demands to slash federal government spending. And last year’s Senate fights demonstrate that sometimes the opposition comes from within the Democratic Party.
  • While some abortion advocates praised Biden for vowing to veto a federal abortion ban, others felt he did not talk enough about the looming challenges to abortion access in the courts. A decision is expected soon in a Texas court case challenging the future use of mifepristone. The Trump-appointed judge’s decision could ban the drug nationwide, meaning it would be barred even in states where abortion continues to be legal.
  • The FDA is at the center of the abortion pill case, which challenges its approval of the drug decades ago and could set a precedent for legal challenges to the approval of other drugs. In other FDA news, the agency recently changed policy to allow gay men to donate blood; announced new food safety leadership in response to the baby formula crisis; and kicked back to Congress a question of how to regulate CBD, or cannabidiol, products.
  • In drug pricing, the top-selling pharmaceutical, Humira, will soon reach the end of its patent, which will offer a telling look at how competition influences the price of biosimilars — and the problems that remain for lawmakers to resolve.

Also this week, Rovner interviews Kate Baicker of the University of Chicago about a new paper providing a possible middle ground in the effort to establish universal health insurance coverage in the U.S.

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

Julie Rovner: The New York Times’ “Don’t Let Republican ‘Judge Shoppers’ Thwart the Will of Voters,” by Stephen I. Vladeck

Alice Miranda Ollstein: Politico’s “Mpox Is Simmering South of the Border, Threatening a Resurgence,” by Carmen Paun

Sarah Karlin-Smith: KHN’s “Decisions by CVS and Optum Panicked Thousands of Their Sickest Patients,” by Arthur Allen

Rachel Cohrs: ProPublica’s “UnitedHealthcare Tried to Deny Coverage to a Chronically Ill Patient. He Fought Back, Exposing the Insurer’s Inner Workings,” by David Armstrong, Patrick Rucker, and Maya Miller

Also mentioned in this week’s podcast:

click to open the transcript

Transcript: A Health-Heavy State of the Union

KHN’s ‘What the Health?’Episode Title: A Health-Heavy State of the UnionEpisode Number: 284Published: Feb. 9, 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’re taping this week on Thursday, Feb. 9, 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 Sarah Karlin-Smith of the Pink Sheet.

Sarah Karlin-Smith: Hi, Julie.

Rovner: Later in this episode, we’ll play my interview with Kate Baicker of the University of Chicago. She’s one of the authors of a new paper outlining a new proposal for the U.S. to achieve universal health insurance coverage, something every other developing nation already has, but we have not yet been able to achieve. But first, this week’s health news. We’re going to start, of course, with the State of the Union, which was livelier than usual, with way more back and forth than I’ve ever seen at one of these, and also more health-heavy than usual. I’m going to start with entitlements, notably the president threatening Republican proposals to hold the debt ceiling hostage for cuts in Social Security and Medicare. I’m still trying to decide whether this was intended or not, but Biden nevertheless ended up getting Republicans to vow not to demand cuts in Social Security and Medicare in exchange for raising the debt ceiling later this year. Here is the tape.

President Joe Biden: So, folks, as we all apparently agree, Social Security and Medicare is off the books now, right? And they’re not going to strike … [prolonged applause] All right. We got unanimity!

Rovner: So was this very clever or very lucky or both?

Ollstein: Well, it’s a little not quite what it seems. Republicans have been swearing up and down more recently that they never intended to cut Medicare and Social Security. But when they say “We want to reform it, we want to shore it up,” they’re talking about things that could limit benefits for beneficiaries. So it’s a semantics game, in part. I also want to point out that neither Republicans nor Biden have yet said that they consider Medicaid in that same untouchable category. So that really jumped out at me in the speech as well.

Rovner: Yeah, I mean, if you don’t touch Social Security or Medicare — and the Republicans are trying to say that because this has been used as a weapon for so many years — then basically that leaves Medicaid. And as we discovered in 2017, when they were trying to repeal the Affordable Care Act, Medicaid is actually pretty popular, too, because it takes care of a lot of people’s grandparents in nursing homes. I’m wondering when somebody is going to bring that up. Obviously, over the years, many, quote-unquote, “cuts” have been made to both Social Security and Medicare, mainly to slow the growth of the programs so that we can continue to afford them. Many more, quote-unquote, “cuts” will have to be made going forward. Every time you reduce payment to a drugmaker or a hospital or any other health care provider, that’s a cut, but it helps beneficiaries. So, you know, you say “cuts,” [and] beneficiaries say “they’re going to cut our benefits.” Not necessarily. They may just be making the program more affordable, including for the beneficiaries. I mean, this is just the continuous back and forth of each side, weaponizing Medicare in particular, right?

Ollstein: Well, and until we see actual proposals on paper, like you’re indicating, it is a semantics game — what some people consider a cut might not be what other people consider a cut. And there’s going to be all sorts of rhetorical games over the next several months along these lines. So, I’m waiting till we see an actual black-and-white proposal that we can all pick at and analyze together.

Rovner: Well, as we have seen, there’s danger in putting things on paper, as Rick Scott discovered this week. For those who don’t remember, it was his rather infamous proposal — was it last summer, I think? It was before the election — suggesting that all federal programs be sunsetted every five years and then have to be reauthorized, which would include Social Security and Medicare and Medicaid. And that’s not playing well at this point, as I think was predicted at the time, including by us. So moving on, I was also impressed at how the speechwriters managed to combine the, quote, “victory lap” stuff, record Affordable Care [Act] enrollment, Medicare drug price changes, limits on insulin, and surprise bills with the agenda ahead: expanding insulin price caps to the non-Medicare population, Medicaid expansion in the states that haven’t done it, making the Affordable Care Act subsidies expansions permanent. But none of these things — popular, though they may be — are likely to happen in this Congress, are they? … These are the things that fell out of the bill that passed last year.

Cohrs: Right. A lot of those cost money, which is going to cause even more problems this Congress than it did in the last one. And I thought it was pretty informative that the chair of the Energy and Commerce Committee in the House threw cold water on the insulin price-cap idea because it did gain some Republican support in the Senate when it came up for a vote. That was complicated. We won’t go into it. But yeah, it wasn’t a straight up-and-down vote on that policy, really. So I think there was some hope that maybe Republicans could get on board with it. But I think, because it applies to private market insurers, [it was called] a socialist policy, like, they just don’t want government in private plans, even though it’s a wildly popular policy. So, yeah, I think that doesn’t seem like a good signal for that policy in particular and for Medicaid expansion and a lot of these things. Democrats couldn’t even do it when they all agreed or had power in both the House and the Senate. So it’s definitely not a good indication for a lot of these things.

Ollstein: Let’s not forget that [Sen. Joe] Manchin [D-W.Va.] was the one who put the kibosh on the federal Medicaid expansion. He thought it wasn’t fair to states like his that expanded a long time ago and have been paying in a little bit. He thought it wasn’t right that states that were holdouts get a free ride. And the other Democrats argued back that it’s not fair for the residents in those states to be left out in the cold uninsured either. So this will continue. But like Rachel said, not going anywhere soon.

Rovner: So the things that in theory could happen, and these didn’t mostly come up in the speech or didn’t come up very much. But earlier in the day, Biden officials were floating a quote-unquote, “unity agenda” that included a long list of potentially bipartisan health issues, starting with the “cancer moonshot,” mental health and opioid treatment, strengthening the mental health parity rules. Some of these things actually could happen, right?

Cohrs: Yeah, I think especially on the mental health package, I think there was some unfinished business from last Congress, from the Senate Finance Committee. I think that all of these are issues that have been talked about this Congress already. And the leaders have signaled that they might be interested in. But I think there is some daylight here, and we’re still in very much the agenda-setting, throwing ideas out there that are a very vague part of this Congress. And I think actually getting things down on paper and going through hearings and that kind of thing will signal which areas there might actually be some agreement on. But again, spending is going to be a big challenge and there’s just not going to be time to get to everything.

Rovner: I think one of my frustrations is that normally the State of the Union comes right before the president’s budget comes out, usually within a week or two. And this year, the president’s budget isn’t coming out until March 9. So we have this, you know, talk about agenda-setting. We’re going to have a lot of time for people to just yap at each other without any specifics. But speaking of things that didn’t and aren’t likely to happen, the president didn’t talk very much about abortion. And what he did say — like threatening to veto any abortion ban Congress might pass, which won’t happen either with Democrats in charge of the Senate — that disappointed abortion rights supporters. They’re not happy, right, Alice?

Ollstein: Some were not. To be fair, some praised the speech, praised the president for saying the word “abortion.” This was a big thing over much of his career, including the beginning of his presidency. He would talk around it and not actually say the word “abortion,” which the groups felt contributed to stigma around it. And so the big mainstream groups, Planned Parenthood, NARAL, put out statements praising the speech, praising him for saying he would veto a ban, although, again, like you said, that’s a hypothetical. It’s not going to happen. But some other groups were critical that, one, he didn’t talk about some of the very looming direct threats to abortion access in the courts that we’re probably going to get to later.

Rovner: In a minute.

Ollstein: Just in a minute! But they were frustrated that he didn’t lay out more specifics that his administration will actually do to respond to the current loss of access in a lot of the country. They felt that we’re in a crisis moment and he spent less of the speech on abortion than he did on resort fees. That was a sore point for some advocates who I talked to.

Rovner: There was a lot of emphasis on junk fees. And I get why: These are the things that drive people crazy, and, particularly, in times of high inflation. But yes, abortion came very late in the speech — almost after a lot of people had tuned out and stopped paying attention, which I think also made some people unhappy. Well, speaking of abortion, here we are waiting for another make-or-break court decision out of Texas. Alice, this time it’s the future of the “abortion pill,” not just in Texas, but around the nation that’s at stake. How did we get here? And could we really see the abortion pill banned nationwide?

Ollstein: We really could. People have really been sleeping on this case, including some elected officials who were slow to realize the impact it could have. And mainly what people don’t understand is a bunch of states already ban all methods of abortion, including the pill, and then some additional states besides that have restrictions just on the pill. So this will mainly hit blue states and states where abortion access still exists. And so it could really have a huge impact because those states are now serving more than just their own populations. And in a lot of places, losing access to medication abortion means losing access to all abortion because there aren’t clinical services available. And so my colleague and I did some reporting on how the Biden administration is preparing or not for this ruling. They rebuffed calls from activists to declare a public health emergency for abortion. They said they don’t think that would help. While they do plan to appeal the ruling should the FDA lose, the upheaval that could happen in the meantime can’t really be overstated. And not to mention that an appeal would go to the 5th Circuit, which is very conservative, and then to the Supreme Court, which just overturned Roe v. Wade. And so while most experts we’ve talked to don’t think the legal arguments are that sound, you just can’t really …

Rovner: And remind us, this is the lawsuit that’s challenging the 22-year-old approval of the drug in the first place.

Ollstein: Exactly. And so health care legal experts also say that besides the absolute upheaval in the abortion space that this could cause, this would just completely destroy any certainty around drug approvals for the FDA. If anybody could come back decades later and challenge the approval of a drug, how can drugmakers feel comfortable developing and submitting things for approval and making their plans around that? It’s very chaotic.

Rovner: Sarah, is the FDA worried about this case? Has it not been on their radar either?

Karlin-Smith: I mean, they’re involved in the defense.

Rovner: They’re being sued.

Karlin-Smith: Right. I think it is a concern if this is used, right? If the folks who want this drug pulled would win, does it become precedent-setting in a way that you can get other products pulled? Perhaps. Again, the sentiments would not be there for a lot of other products in the way to use it. But it is a bit concerning when you think about judges having this power to overrule the scientific decisions we’ve left to civil servants, not politicians or judges, because they have expertise in science and medicine and clinical trial design and all these things we just would not expect judges to be able to rule on.

Rovner: Well, speaking of more politics, this week — actually, last week — a group of 20 state attorneys general from states with abortion restrictions wrote to CVS and Walgreens, which had already announced that they would apply to become providers of the abortion pill, warning them not to rely on the Justice Department’s interpretation of a 19th-century law that banned the use of the U.S. mail to send abortifacients. The letter doesn’t outright threaten the companies. It merely says that, quote, “We offer you these thoughts on the current legal landscape.” Has anybody sued over this yet? And what do we expect to happen here? I mean, are CVS and Walgreens going to back off their plans to become providers?

Ollstein: Well, the anti-abortion elected officials and advocacy groups are hoping that’s the case. But I think this could play out in so many ways. I mean, one, we have this national ruling that could come down, but we also have a few state rulings that could flip things the other way and force states that have put restrictions on the abortion pill to lift those restrictions and allow it. So now we have cases pending in North Carolina and West Virginia. One of them is by the manufacturer of the abortion pill, saying that states don’t have the right to put the FDA’s hat on their own heads and make those decisions. And the other is by an abortion provider, a doctor who says that these state restrictions hurt her ability to practice and hurt her patients. And so it’s just wild that we can swing anywhere from a national ban to forcing states with bans to lift those bans. I mean, it’s just all up in the air right now. I wanted to quickly point out two other things. A lot of activist groups say they are not counting on the Biden administration to adequately respond to this crisis. And so they’re doing a couple things. One, they’re encouraging people to do something known as “advance provision,” which is order abortion pills before they’re pregnant, before you need them, and just have them on hand just in case. And so they’re advising people do that in advance of the ruling. Interestingly, the FDA does not support that practice, but activist groups are encouraging it anyways. And then the other thing is the abortion pill regimen is actually two pills. And the big FDA lawsuit only goes after the first one. And so people are saying, you know, you can terminate a pregnancy just by taking a few of the second pill, even though that has a higher rate of not working and needing a follow-up procedure. And so …

Rovner: Although it’s still like, 95%, right?

Ollstein: It’s still very effective, but not quite as effective as using the two pills together.

Rovner: And I think it used to be when people would go to Mexico, that’s what they would get. They would get misoprostol, not mifepristone, which is what we think of as “the abortion pill” — and also methotrexate, which we talked about in the context of people with diseases for which methotrexate is indicated not being able to get it because it can cause abortions. But that’s another option there, right? And … it would be hard for FDA to pull those drugs because those drugs do have a lot of uses for other diseases.

Karlin-Smith: Or FDA could, I guess, be forced to take off the formal indication for use for abortion, but the drug would be out there and then could be subject to off-label prescribing, which then could potentially, I guess, impact insurance coverage if you’re using it for abortion. Pivot to if you had to go back to this one-drug regimen while, yes, it would still exist and be possible, I think a lot of providers are worried about the added burden that would create on folks that help people obtain abortion. And this system is just not set up to have enough workers to deal with that more complicated regimen. And it seems like it could end up leading to more need for surgical abortions, depending on how well it works and so forth. So I think logistically it creates a lot more challenges.

Rovner: Yeah, it’s a mess. Well, meanwhile, last issue here, we have a curious story out of a lawsuit in federal district court here in Washington, D.C., in which a judge proffered the notion that while the Supreme Court may have found no right to abortion in the 14th Amendment, that doesn’t mean there isn’t a federal right under the 13th Amendment. That’s the one barring slavery, specifically the restriction on the pregnant person’s personal liberty. As the judge correctly pointed out, the majority in last year’s Dobbs [v. Jackson Women’s Health Organization] ruling may well believe there’s no right to abortion anywhere in the Constitution. But that’s not the question that they litigated. Is this potentially an avenue that abortion rights advocates are going to explore?

Ollstein: I am not hearing a lot of hope being placed on this. If it goes anywhere, it would go back to the same Supreme Court that just ruled last year. And so abortion rights advocates are not optimistic about this strategy, but I think it’s a good indication of really both sides right now just trying to get as creative as possible and explore every legal avenue in the U.S. Constitution, in state constitutions, things where it never says the word abortion, but you could interpret it a certain way. I think that’s what we’re seeing right now. And so it’s really interesting to see where it goes.

Rovner: We are literally at the point where everybody is throwing whatever they can against the wall and seeing what sticks. All right. Well, let us turn to the federal research establishment. Late last month, a panel of advisers recommended a set of policies to strengthen oversight of so-called gain-of-function research that could inadvertently cause new pandemics. This was also one of the subjects of the first House hearing that called leading federal public health officials up on the carpet. What do we learn from the hearing? And has the federal government actually been funding gain-of-function research, or do we even know for sure?

Cohrs: So there has been a moratorium on this sort of research. And the interim director of the NIH [National Institutes of Health] quibbled over the term “gain-of-function research.” And he said we’re talking about a very select part of all of the research that could technically fall under that umbrella term. But he did say that there is a moratorium on funding that right now; there’s not current funding because they are reviewing their practices. And an advisory board did pass proposals and he laid out the process forward for that. So once those are finalized, he’ll write a memo to [Department of Health and Human Services] HHS Secretary Xavier Becerra, then it will get to the White House. So there is this bureaucratic progression that these new guidelines are going to go under, and it’s been pretty transparent and public so far. But we’ll see how things ultimately turn out. But I think they are very sensitive to this politically and they are trying to create guidelines that offer some lessons learned from some of the criticism they’ve gotten recently.

Rovner: And I think, I mean, this has become one of the major lines of argument about Republicans trying to figure out where covid came from. Perhaps it came from U.S.-funded gain-of-function research in China, which we don’t know, I don’t think. But there’s been a lot of “Yes, you did”-“No, you didn’t” going on. I mean, Sarah, does this go back to the, you know, politicians playing scientists?

Karlin-Smith: A little bit. And I think at the hearing, a lot of the Republicans who are pressuring NIH in particular on this are not super interested in listening to the subtleties and nuance of the argument. They just really want to make the point and bring up in people’s minds the possibility of, you know, covid being a lab leak, which I think … which hasn’t 100% been ruled out, but it’s kind of on the 98%, probably 99% ruled out by a lot of scientists. And so it was very hard for NIH and those lawmakers to have a reasonable discussion about the nuances and where this research might possibly benefit us in future pandemic prep. What type of precautions do need to be put in place? And I think NIH was trying to strive to communicate that actually a lot of what was recommended in this oversight report is things they’ve been working on and have put in place. But the hearing was designed by Republicans more to land those political punches and sound bites and not really delve into “Are there policy improvements that could be made here?”

Rovner: Well, speaking of civil servants trying to do their science policy jobs, the FDA’s been busy the last couple of weeks, including lifting a ban on men who have sex with other men donating blood. That’s a ban that’s been in effect in one way or another since the 1980s, when AIDS was first discovered. And in the wake of baby formula shortages, there’s now going to be a new deputy commissioner for food. And finally, the agency is asking Congress for new authority to regulate CBD [cannabidiol] products, particularly as more states legalize marijuana in all forms for recreational use. Sarah, this is an awful lot of stuff at once. Big policy changes where they try to hide some of them, or did they just all show up at once because that’s when they got finished?

Karlin-Smith: The food changes were sort of driven by events not quite within their control, and the blood policy, the CBD stuff were things in the works for some number of years now. So FDA is busy, and these are different divisions operating under it. I think the CBD stuff is drawing a lot of frustration because FDA had been working on considering how to regulate this aspect of hemp for a while now. And instead of coming up with a policy and taking action, they’ve rewound the circle; we’re back to square one and putting it on Congress’ issues. So that’s like one area where there’s a lot of frustration versus, I think, people are generally happier that the blood donation process was finally gone through and changed.

Rovner: Yes, the wheels of the federal regulatory process move slowly, as we know. All right. Finally this week, drug prices. Humira — which is a biological that treats rheumatoid arthritis and many other serious ailments, and for which you have undoubtedly seen TV commercials if you have ever turned on your television, because it’s the top-selling pharmaceutical in the world — is reaching the end of its patent life. That will soon provide the first real test of where the Affordable Care Act’s pathway to allow biosimilar competitors — effectively biologics version of generic drugs — whether that will actually bring down prices. Because there’s a chance here that there’s going to be a bunch of competitors to Humira and the price isn’t going to come down, right?

Karlin-Smith: Yeah, I mean, that’s a major concern for a number of reasons that get us back to the broader U.S. drug pricing debate and — including the role of pharmacy benefit managers in figuring out how people get coverage of their drugs. So Humira is one of the first biologics to lose patent protection, where patients actually fill the prescriptions themselves and give themselves the medicine, which is a very different payment system than if you’re getting a biologic medicine at a doctor’s office or a hospital. And so the way that most of the insurers are covering the drug for this year, they’re actually going to charge patients the same out-of-pocket cost in most instances, as if you’ve got the brand drug or the biosimilar. And because, unlike traditional generic medicines, a lot of these, at least initially, they’re not what is called auto-substitutable. So if your doctor writes you Humira, the pharmacist doesn’t automatically give you that generic. So you’d actually have to request a new prescription from your doctor, and they’d have to write it. And if you’re not going to pay less, why are you motivated to do that?

Rovner: When you’re not even positive how much whether the drug works the same way, whether the biosimilar works the same way.

Karlin-Smith: Right. And they think people are a little bit more hesitant. They don’t understand how biosimilars work compared to generic drugs, where it took — again, when the generic drug industry first started, it took people a while to get comfortable. So there are those issues. So, basically, what has happened is AbbVie has given insurance plans and payers’ discounts on their brand drug to keep it in a good place on their formularies. So there will be savings to the broader health system, for sure. The problem is if that doesn’t get passed on to the patients, and AbbVie can continue their market monopoly, my worry is, down the line, what happens to this biosimilar industry overall? Humira is not the only top-selling, big-selling biologic medicine where we want to bring down the cost. So if these biosimilar competitors don’t eventually gain market share and make money off of doing this, why are they going to go back and develop a biosimilar and try and lower the cost of the next big drug? And that’s what people are watching. I think there’s cautious optimism that, as more biosimilars for Humira launch, there will be some pressure for insurance companies to cut deals and lower prices and not just rely on making money off high rebates. But we don’t really know how it’s going to play out. And AbbVie was pretty creative over the years. In some ways that helped patients and others questionable — how much of … like, you know, there’s high concentration of the drug, low concentration. There is citrate-free, non-citrate-free. And that means that not all the competitors are going to be exactly the same in a way that creates as much competition as it seems at first. So yeah, it’s going to be messy.

Rovner: This is the famous evergreening that we saw with drugs. I mean, where they would change something small and get a whole new patent life.

Karlin-Smith: Right. So usually with generic research, you need three direct competitors to help bring the price down a lot. But in the case of Humira, while there’s going to be, probably at least six competitors this summer, maybe more, they’re not all direct competitors for the same version of Humira. So it sort of bifurcates the space a bit more and makes it harder to, you know, figure out the economics of all of that.

Rovner: Well, if you thought that drug pricing was confusing, now we’re adding a whole new level to it. So, I’m sure we will be talking about this more as we go forward. OK. That’s the news for this week. Now, we will play my interview with Kate Baicker of the University of Chicago. Then we will come back and do our extra credits.

I am excited to welcome to the podcast Katherine Baicker, currently the dean of the University of Chicago Harris School of Public Policy and soon to be provost of the university. Congratulations.

Katherine Baicker: Thank you so much.

Rovner: So, Kate is a health economist who is well known to health policy students for a lot of things, but most notably as the co-lead author of the Oregon Medicaid health experiment, which was able to follow a randomized population of people who got Medicaid coverage and a population that didn’t to help determine the actual impact of having Medicaid health insurance. Today, she’s here as lead author of a paper with a new way to possibly provide health coverage to all Americans. Kate, thank you so much for joining us.

Baicker: It’s a pleasure.

Rovner: So your new paper is called “Achieving Universal Health Insurance Coverage in the United States: Addressing Market Failures or Providing a Social Safety Net.” And in that single sentence, you’ve pretty much summed up the entire health insurance debate for, like, the last half-century. For those who don’t know, why is it that the U.S. doesn’t have universal insurance when literally all of our economic competitors do?

Baicker: Well, like so many things about our health care system, it goes back to the history of how it evolved, as well as some things that are different about the U.S. from other countries. If you look at how big the U.S. is geographically, how diverse our country is, how heterogeneous the health needs are. A lot of the solutions you see in other countries might not work so well in the U.S.

Rovner: So … and we’ve basically just not ever gotten over the hump here.

Baicker: Well, I also think we haven’t been asking the right questions necessarily. There is a real debate about whether health care is a “right” or not. And, of course, your listeners can’t see my “air quotes,” but I put that in air quotes because I think that’s the wrong question. Health care is not just one thing. Health care is a continuum of things. And if we just boil it down to should people have access to care or not, that doesn’t let us engage with the hard question of how much care we want to provide to everyone and how we’re going to pay for it.

Rovner: So I know a lot of people assume that the Affordable Care Act would — I’ll use my air quotes — “fix” the U.S. health insurance problem. And it has gone a long way to cover a lot of previously uninsured people. But who are the rest of the uninsured and why don’t they have coverage? It’s not necessarily who you think, right?

Baicker: That’s right. And, you know, the ACA, or Obamacare, actually made a lot of headway in covering big swaths of the uninsured population. There was a lot of discussion about health insurance exchanges, but actually more people were covered by Medicaid expansions than by health insurance exchanges. But both of those, as well as letting young people up to age 26 get on their parents’ policies. All of this chipped away at the ranks of the uninsured, but it left, for example, undocumented immigrants uninsured and also the vast majority of the uninsured people in the U.S. are already eligible for either a public program or heavily subsidized private insurance. And we have a problem of takeup and availability, not just affordability.

Rovner: So let’s get to your proposal. It’s not really that different from things that either we’ve tried in some parts of our health insurance ecosystem or what other countries do. What would it actually look like if we were to do it?

Baicker: Well, if you go back to what I think is the right question of how much health care do we want to make sure that everyone has access to and how are we going to get them enrolled in those programs? I think one key feature is having that coverage be as low-hassle as possible, automatic if possible, because we know that nonfinancial barriers to insurance are responsible for a lot of the uninsured population we still see today.

Rovner: We’ve seen that with pension plans, right? That automatically enrolling people get more people to actually put money away?

Baicker: That’s right. That’s one of the takeaways from behavioral economics is that defaults matter. Meaning what the baseline is and letting you opt in and out makes a big difference because people tend to stick with where they are. There’s a lot of inertia in saving for retirement, in enrolling in health insurance, in lots of different things. And being sophisticated in how we design the mechanics of those programs is important, as well as making sure that they’re financially affordable to people. So one step is making sure that whatever is available to people is as easy as possible for them to take advantage of. But the other is having a much harder discussion about what we want that basic package to be. And when you say “I want everybody to have all of the care that might possibly be available, no matter what price and no matter how much it impacts their health,” that’s more than 100% of GDP. We just can’t do that and still have any money for anything like food and housing and education and roads and all of the things that we also care about. So if we had that tough discussion as a nation, as a body politic, to say, here is the care that we think is really high-value that we think is a right for everyone and that we want to make sure is available to everyone, then people could be automatically enrolled in that default package and have the option to get more care that is more expensive and maybe a little less effective, but still worth it to them that they purchase on their own. And that opens up a whole host of other questions and ethical dilemmas that I’m sure you’re going to want to ask about.

Rovner: But it also — as a lot of people are concerned, that something like “Medicare for All” would eliminate the incentive to innovate new kinds of care. I mean, obviously, there’s this race to figure out, you know, a drug to treat Alzheimer’s and that if the federal government were to basically set prices for everything, that there would be no more innovation incentive. You actually address that here, right?

Baicker: Yes. And I’m so glad you raised that concern, because there are many challenges to having a monolithic one-size-fits-all Medicare for All type plan. One of them is, you know, affordability for the system and accessibility. But another is the dulled incentive for innovation and the dulled drive towards having new medicines and new treatments available. Medicare is very slow to innovate. It took 40-plus years for Medicare to include prescription drugs at all. And that was because when Medicare was formed in the Sixties, prescription medicine wasn’t a very important part of health care. It wasn’t a very expensive part of health care, there just weren’t that many drugs to treat people. Well, now those medicines are crucial to health and well-being. And Medicare finally added a prescription drug benefit in 2005. But that was a long lag, and that’s just one example. So I think having some fundamental access to care that we know is of high value for everyone could be coupled with having the option to purchase more generous insurance that covers more things. And that private insurance layered on top would really provide the financial incentives for continued innovation. It acknowledges the reality that in a world of scarce resources, higher-income people are going to have more health care than lower-income people. And that is an ugly reality and one that we ought to grapple with ethically, and as a matter of public policy priorities. I would argue we’re already rationing care. It is not possible for public programs to pay for all care for all people, no matter what the price, no matter what the health benefit, and being intentional about defining what it is we’re going to cover with public dollars and then letting people buy more care with private dollars is a way perhaps to make a financially sustainable system that also promotes innovation.

Rovner: And this isn’t really new. I mean, lots of other countries do this. I was in Switzerland a decade ago, and I remember that they … their extra-benefit package includes things like single rooms in hospitals and homeopathic medicine and things that I’m not sure we would end up putting into our top-up plans, but it’s something that’s important to them.

Baicker: Yes. And when people point to our European counterparts and say, look, they all have single-payer. In fact, a lot of them have a hybrid system like the one that we’re describing. And it’s important to differentiate: We’re talking about a basic plan that’s available for everyone. That doesn’t mean that it only covers cheap things. It should only cover high-value things. But some cheap things are incredibly ineffective and low-value, and some expensive things are really important for health and very high-value. So it’s about the value of the dollar spent in terms of producing health, not whether it’s expensive or cheap. And so when you think about having a top-up plan, it shouldn’t be about billing cost sharing that, you know, lower-income people are exposed to in the basic plan. It should be about adding services that are of less health importance but still valuable to the people purchasing them.

Rovner: Obviously, the biggest issue here is going to be who’s going to make that determination? I’m old enough to remember fights over the ACA, death panels, and the independent Medicare advisory board that never happened. In fact, there were a lot of these, you know, we’re going to appoint experts. And it never happened because none of the experts ever wanted to be on these panels. How do you overcome that hurdle of actually grappling with the decision of what should be covered?

Baicker: Yes, the devil is always in the details for these things, and you put your finger on a really important one where we haven’t provided a robust answer, and our analysis is meant to highlight the importance of making these hard decisions and the value of this framework. But we don’t have a magic bullet for this. I would argue that having Congress make this decision every year is a recipe for lobbying and decision-making that doesn’t actually line up with value. There’s an opportunity perhaps to have a panel of experts who, as you note, is just a hop, skip and a jump from being called a “death panel.” But I think we can rely on some clinical guidelines as guardrails on this. And we do have some examples of experimentation in this direction in the U.S. In fact, more than experimentation — if you look at Medicare Advantage, this used to be a small part of the Medicare program. These are private plans for Medicare beneficiaries that are now, I think, pretty soon going to be the majority of plans that people have. And it’s a mechanism for people to choose among plans that have some things that have to be covered, but can then add additional benefits for enrollees, and it can be a little more tailored to what people value in their plans. So I don’t think that’s the answer either. But it’s a proof of concept that we can do something like this in the U.S.

Rovner: So in some ways this would bridge the gap between Republican marketplace ideas and Democratic Medicare for All ideas. But it feels like, since the fight over the Affordable Care Act, Republicans have moved more to the right on health care and Democrats have moved more to the left on health care. You are no stranger to partisan politics nor the ways of Washington, D.C. How could everybody be brought back to what I daresay looks like a political compromise?

Baicker: Well, I’m an economist, as you noted, and that’s notoriously bad at understanding actual human beings. I don’t have any idea for the path forward through the political thicket that we’re in. In some ways, it is a little disheartening to see how difficult it is to do some basic commonsense things. In any complicated system like the U.S. health care system, there are always small technical fixes that need to be made that are just commonsense, that ought not to be political. And it’s hard to do those.

Rovner: We’re lacking in common sense right now in Washington.

Baicker: Yeah. So I can’t say that I’m hugely optimistic about a big change happening right away. On the other hand, I think covid really highlighted to people across the political spectrum how important it is to have continuity of coverage, how disparate our current system is in terms of access to care, how problematic it is to have your main avenue of health insurance be through your employer when a pandemic is coupled with a recession. So I think the challenges and the vast inequities of our health care system were laid bare during covid. So it is perhaps salient enough that people might be willing to consider alternative structures. But I can’t say I’m holding my breath.

Rovner: Well, Kate Baicker, thank you very much for, if anything, a great thought experiment. It’s really wonderful to look your way through … it’s like, oh, we could get there, maybe in another half a century.

Baicker: I hope sooner than that.

Rovner: I do, too. Thank you so much.

Baicker: My pleasure.

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 khn.org and in our show notes on your phone or other mobile device. Rachel, why don’t you go first this week?

Cohrs: My extra credit is headlined “UnitedHealthcare Tried to Deny Coverage to a Chronically Ill Patient. He Fought Back, Exposing the Insurer’s Inner Workings,” in ProPublica by David Armstrong, Patrick Rucker, and Maya Miller. And I thought this story was just such a good illustration of the jargon that we use in D.C., of, like, utilization management and prior authorization. And sometimes these terms just feel so impersonal. But I feel like this story did such a good job walking through one patient’s struggle to find something that worked and then just the arbitrary choices that insurers were making, looking at their bottom line to try to prevent him from getting a very expensive treatment that actually did increase his quality of life significantly. So I would definitely recommend, as we’re thinking about insurers’ role in this whole health care cost debate as well.

Rovner: Yeah, it does bring home how the patient is always in the middle of this. Alice.

Ollstein: I chose a piece by my colleague Carmen Paun called “Mpox Is Simmering South of the Border, Threatening a Resurgence,” and it’s about how the U.S. was extremely successful in vaccinating high-risk people against mpox, which for folks who still remember the artist formerly known as monkeypox, the name was changed to reduce stigma and be more accurate. The U.S. vaccination campaign and messaging campaign to the most high-risk populations was really successful and did the trick. But as we learned from covid and every other infectious disease, if you don’t take care of other parts of the world, it could eventually come back. We’re not an island, and even islands aren’t safe. But, you know, this is about a bunch of countries, including Mexico, that really have made no mass vaccination effort at all. You know, some civil society groups are trying on their own, but they just don’t have official government backing. And that’s really dangerous. And it meant that cases are surging in parts of Latin America and parts of Africa. And as we saw from covid, that leads to the development of new variants and things traveling back to the U.S. and other places around the world. So, certainly, something to pay attention to.

Rovner: Public health is important. World public health is important. Sarah.

Karlin-Smith: I looked at a piece called “Decisions by CVS and Optum Panicked Thousands of Their Sickest Patients,” by Arthur Allen for Kaiser Health News. It’s a deep dive into CVS and Optum moving out of, to some degree, business places where they provide home infusion services of perinatal nutrition to people that essentially cannot eat or drink in most cases. And they basically decided that it’s not a great business opportunity for them in many cases. But these are people that really depend on these services to live and survive, and they’re very complex medicines and essential nutrition to get and deliver. And at the same time, I think what really fascinated me about this story is it talks about this dynamic of while companies are getting out of the space where you’re providing this service to people that need these IV treatments to survive and live, there also has been development of these medical spas, as they’re called, where people that actually do not need IV hydration or IV nutrition are essentially being given it for nonmedical purposes. And there’s a lot of money being made there. And it just shows you how some of the profit incentives in our system don’t necessarily align with treating the people that actually need the health care first.

Rovner: Yeah, it’s like the people with diabetes not being able to get their drugs because people in Hollywood want to lose 10 pounds fast. But this obviously is, you know, another life-or-death issue. Well, I chose an op-ed this week in The New York Times by the University of Texas law professor Steven I. Vladeck called “Don’t Let Republican ‘Judge Shoppers’ Thwart the Will of Voters.” And it answered a lot of questions for me. First, how is it that so many suits end up in front of the same judges who the plaintiffs know are likely to rule in their favor, and all in Texas? So it turns out that Texas has distributed its federal judges in a way that in nine districts there is only one judge. And in 10 more, there are only two judges. Obviously, there’s no random draw in those districts where there’s only one judge. That’s what you’re going to get. So we keep seeing some of the same Texas judges, first Judge Reed O’Connor in Fort Worth, and now Matthew Kacsmaryk, a former advocate for a conservative think tank and the only federal judge in Amarillo. Judge O’Connor had the big ACA case, now has a big preventive care case. Judge Kacsmaryk has the abortion pill case that we’ve been talking about. It’s a really interesting piece about how that could really twist justice. But it also includes several ways to fix it. We’ll have to see if any of them actually get taken up.

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 — all one word — @kff.org. Or you can tweet me as long as Twitter is still up. I’m @jrovner. Alice?

Ollstein: @AliceOllstein

Rovner: Rachel

Cohrs: @rachelcohrs

Rovner: Sarah.

Karlin-Smith: @SarahKarlin

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

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Editor

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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.

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2 years 5 months ago

Aging, Courts, Insurance, Medicare, Multimedia, Pharmaceuticals, The Health Law, Abortion, Biden Administration, Drug Costs, FDA, KHN's 'What The Health?', Podcasts, Premiums, Prescription Drugs, U.S. Congress, Women's Health

Kaiser Health News

Decisions by CVS and Optum Panicked Thousands of Their Sickest Patients

NEW YORK — The fear started when a few patients saw their nurses and dietitians posting job searches on LinkedIn.

Word spread to Facebook groups, and patients started calling Coram CVS, a major U.S. supplier of the compounded IV nutrients on which they rely for survival. To their dismay, CVS Health confirmed the rumors on June 1: It was closing 36 of the 71 branches of its Coram home infusion business and laying off about 2,000 nurses, dietitians, pharmacists, and other employees.

Many of the patients left in the lurch have life-threatening digestive disorders that render them unable to eat or drink. They depend on parenteral nutrition, or PN — in which amino acids, sugars, fats, vitamins, and electrolytes are pumped, in most cases, through a specialized catheter directly into a large vein near the heart.

The day after CVS’ move, another big supplier, Optum Rx, announced its own consolidation. Suddenly, thousands would be without their highly complex, shortage-plagued, essential drugs and nutrients.

“With this kind of disruption, patients can’t get through on the phones. They panic,” said Cynthia Reddick, a senior nutritionist who was let go in the CVS restructuring.

“It was very difficult. Many emails, many phone calls, acting as a liaison between my doctor and the company,” said Elizabeth Fisher Smith, a 32-year-old public health instructor in New York City, whose Coram branch closed. A rare medical disorder has forced her to rely on PN for survival since 2017. “In the end, I got my supplies, but it added to my mental burden. And I’m someone who has worked in health care nearly my entire adult life.”

CVS had abandoned most of its less lucrative market in home parenteral nutrition, or HPN, and “acute care” drugs like IV antibiotics. Instead, it would focus on high-dollar, specialty intravenous medications like Remicade, which is used for arthritis and other autoimmune conditions.

Home and outpatient infusions are a growing business in the United States, as new drugs for chronic illness enable patients, health care providers, and insurers to bypass in-person treatment. Even the wellness industry is cashing in, with spa storefronts and home hydration services.

But while reimbursement for expensive new drugs has drawn the interest of big corporations and private equity, the industry is strained by a lack of nurses and pharmacists. And the less profitable parts of the business — as well as the vulnerable patients they serve — are at serious risk.

This includes the 30,000-plus Americans who rely for survival on parenteral nutrition, which has 72 ingredients. Among those patients are premature infants and post-surgery patients with digestive problems, and people with short or damaged bowels, often the result of genetic defects.

While some specialty infusion drugs are billed through pharmacy benefit managers that typically pay suppliers in a few weeks, medical plans that cover HPN, IV antibiotics, and some other infusion drugs can take 90 days to pay, said Dan Manchise, president of Mann Medical Consultants, a home care consulting company.

In the 2010s, CVS bought Coram, and Optum bought up smaller home infusion companies, both with the hope that consolidation and scale would offer more negotiating power with insurers and manufacturers, leading to a more stable market. But the level of patient care required was too high for them to make money, industry officials said.

“With the margins seen in the industry,” Manchise said, “if you’ve taken on expensive patients and you don’t get paid, you’re dead.”

In September, CVS announced its purchase of Signify Health, a high-tech company that sends out home health workers to evaluate billing rates for “high-priority” Medicare Advantage patients, according to an analyst’s report. In other words, as CVS shed one group of patients whose care yields low margins, it was spending $8 billion to seek more profitable ones.

CVS “pivots when necessary,” spokesperson Mike DeAngelis told KHN. “We decided to focus more resources on patients who receive infusion services for specialty medications” that “continue to see sustained growth.” Optum declined to discuss its move, but a spokesperson said the company was “steadfastly committed to serving the needs” of more than 2,000 HPN patients.

DeAngelis said CVS worked with its HPN patients to “seamlessly transition their care” to new companies.

However, several Coram patients interviewed about the transition indicated it was hardly smooth. Other HPN businesses were strained by the new demand for services, and frightening disruptions occurred.

Smith had to convince her new supplier that she still needed two IV pumps — one for HPN, the other for hydration. Without two, she’d rely partly on “gravity” infusion, in which the IV bag hangs from a pole that must move with the patient, making it impossible for her to keep her job.

“They just blatantly told her they weren’t giving her a pump because it was more expensive, she didn’t need it, and that’s why Coram went out of business,” Smith said.

Many patients who were hospitalized at the time of the switch — several inpatient stays a year are not unusual for HPN patients — had to remain in the hospital until they could find new suppliers. Such hospitalizations typically cost at least $3,000 a day.

“The biggest problem was getting people out of the hospital until other companies had ramped up,” said Dr. David Seres, a professor of medicine at the Institute of Human Nutrition at Columbia University Medical Center. Even over a few days, he said, “there was a lot of emotional hardship and fear over losing long-term relationships.”

To address HPN patients’ nutritional needs, a team of physicians, nurses, and dietitians must work with their supplier, Seres said. The companies conduct weekly bloodwork and adjust the contents of the HPN bags, all under sterile conditions because these patients are at risk of blood infections, which can be grave.

As for Coram, “it’s pretty obvious they had to trim down business that was not making money,” Reddick said, adding that it was noteworthy both Coram and Optum Rx “pivoted the same way to focus on higher-dollar, higher-reimbursement, high-margin populations.”

“I get it, from the business perspective,” Smith said. “At the same time, they left a lot of patients in a not great situation.”

***

Smith shares a postage-stamp Queens apartment with her husband, Matt; his enormous flight simulator (he’s an amateur pilot); cabinets and fridges full of medical supplies; and two large, friendly dogs, Caspian and Gretl. On a recent morning, she went about her routine: detaching the bag of milky IV fluid that had pumped all night through a central line implanted in her chest, flushing the line with saline, injecting medications into another saline bag, and then hooking it through a paperback-sized pump into her central line.

Smith has a connective tissue disorder called Ehlers-Danlos syndrome, which can cause many health problems. As a child, Smith had frequent issues such as a torn Achilles tendon and shoulder dislocations. In her 20s, while working as an EMT, she developed severe gut blockages and became progressively less able to digest food. In 2017, she went on HPN and takes nothing by mouth except for an occasional sip of liquid or bite of soft food, in hopes of preventing the total atrophy of her intestines. HPN enabled her to commute to George Washington University in Washington, D.C., where in 2020 she completed a master’s in public health.

On days when she teaches at LaGuardia Community College — she had 35 students this semester — Smith is up at 6 a.m. to tend to her medical care, leaves the house at 9:15 for class, comes home in the afternoon for a bag of IV hydration, then returns for a late afternoon or evening class. In the evening she gets more hydration, then hooks up the HPN bag for the night. On rare occasions she skips the HPN, “but then I regret it,” she said. The next day she’ll have headaches and feel dizzy, sometimes losing her train of thought in class.

Smith describes a “love-hate relationship” with HPN. She hates being dependent on it, the sour smell of the stuff when it spills, and the mountains of unrecyclable garbage from the 120 pounds of supplies couriered to her apartment weekly. She worries about blood clots and infections. She finds the smell of food disconcerting; Matt tries not to cook when she’s home. Other HPN patients speak of sudden cravings for pasta or Frosted Mini-Wheats.

Yet HPN “has given me my life back,” Smith said.

She is a zealous self-caretaker, but some dangers are beyond her control. IV feeding over time is associated with liver damage. The assemblage of HPN bags by compounding pharmacists is risky. If the ingredients aren’t mixed in the right order, they can crystallize and kill a patient, said Seres, Smith’s doctor.

He and other doctors would like to transition patients to food, but this isn’t always possible. Some eventually seek drastic treatments such as bowel lengthening or even transplants of the entire digestive tract.

“When they run out of options, they could die,” said Dr. Ryan Hurt, a Mayo Clinic physician and president of the American Society for Parenteral and Enteral Nutrition.

***

And then there are the shortages.

In 2017, Hurricane Maria crippled dozens of labs and factories making IV components in Puerto Rico; next came the covid-19 emergency, which shifted vital supplies to gravely ill hospital patients.

Prices for vital HPN ingredients can fluctuate unpredictably as companies making them come and go. For example, in recent years the cost of the sodium acetate used as an electrolyte in a bag of HPN ballooned from $2 to $25, then briefly to $300, said Michael Rigas, a co-founder of the home infusion pharmacy KabaFusion.

“There may be 50 different companies involved in producing everything in an HPN bag,” Rigas said. “They’re all doing their own thing — expanding, contracting, looking for ways to make money.” This leaves patients struggling to deal with various shortages from saline and IV bags to special tubing and vitamins.

“In the last five years I’ve seen more things out of stock or on shortage than the previous 35 years combined,” said Rigas.

The sudden retrenchment of CVS and Optum Rx made things worse. Another, infuriating source of worry: the steady rise of IV spas and concierge services, staffed by moonlighting or burned-out hospital nurses, offering IV vitamins and hydration to well-off people who enjoy the rush of infusions to relieve symptoms of a cold, morning sickness, a hangover, or just a case of the blahs.

In January, infusion professionals urged FDA Commissioner Robert Califf to examine spa and concierge services’ use of IV products as an “emerging contributing factor” to shortages.

The FDA, however, has little authority over IV spas. The Federal Trade Commission has cracked down on some spa operations — for unsubstantiated health claims rather than resource misuse.

Bracha Banayan’s concierge service, called IVDRIPS, started in 2017 in New York City and now employs 90 people, including 60 registered nurses, in four states, she said. They visit about 5,000 patrons each year, providing IV hydration and vitamins in sessions of an hour or two for up to $600 a visit. The goal is “to hydrate and be healthy” with a “boost that makes us feel better,” Banayan said.

Although experts don’t recommend IV hydration outside of medical settings, the market has exploded, Banayan said: “Every med spa is like, ‘We want to bring in IV services.’ Every single paramedic I know is opening an IV center.”

Matt Smith, Elizabeth’s husband, isn’t surprised. Educated as a lawyer, he is a paramedic who trains others at Columbia University Irving Medical Center. “You give someone a choice of go up to some rich person’s apartment and start an IV on them, or carry a 500-pound person living in squalor down from their apartment,” he said. “There’s one that’s going to be very hard on your body and one very easy on your body.”

The very existence of IV spa companies can feel like an insult.

“These people are using resources that are literally a matter of life or death to us,” Elizabeth Smith said.

Shortages in HPN supplies have caused serious health problems including organ failure, severe blisters, rashes, and brain damage.

For five months last year, Rylee Cornwell, 18 and living in Spokane, Washington, could rarely procure lipids for her HPN treatment. She grew dizzy or fainted when she tried to stand, so she mostly slept. Eventually she moved to Phoenix, where the Mayo Clinic has many Ehlers-Danlos patients and supplies are easier to access.

Mike Sherels was a University of Minnesota Gophers football coach when an allergic reaction caused him to lose most of his intestines. At times he’s had to rely on an ethanol solution that damages the ports on his central line, a potentially deadly problem “since you can only have so many central access sites put into your body during your life,” he said.

When Faith Johnson, a 22-year-old Las Vegas student, was unable to get IV multivitamins, she tried crushing vitamin pills and swallowing the powder, but couldn’t keep the substance down and became malnourished. She has been hospitalized five times this past year.

Dread stalks Matt Smith, who daily fears that Elizabeth will call to say she has a headache, which could mean a minor allergic or viral issue — or a bloodstream infection that will land her in the hospital.

Even more worrying, he said: “What happens if all these companies stop doing it? What is the alternative? I don’t know what the economics of HPN are. All I know is the stuff either comes or it doesn’t.”

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.

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This story can be republished for free (details).

2 years 5 months ago

Health Care Costs, Health Industry, Pharmaceuticals

STAT

STAT+: Pharmalittle: AbbVie to lift $2B cap on deals as Humira rivals appear; India to spend $80M to bolster regulatory system

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so-familiar routine of online meetings, conferences and deadlines has predictably returned. But what can you do? The world, such as it is, keeps spinning.

So to give it a nudge in a useful direction, we are firing up the coffee kettle to brew another cup of stimulation. Our choice today is maple bourbon. As always, you are invited to join us. Meanwhile, here is the latest menu of tidbits to help you start your journey. We hope your day is productive and meaningful. And of course, do keep in touch. We are searching for new pen pals …

Now that its blockbuster immune-disease therapy Humira is facing lower-priced competition, AbbVie is turning to a pair of next-generation successors to replenish the billions of dollars in sales that will be lost, The Wall Street Journal writes. The company is also betting on four drug approvals by the end of next year. In addition, AbbVie is lifting a self-imposed $2 billion limit on the size of deals it would do to add more products. AbbVie is counting most on persuading doctors that two newer immune drugs, Skyrizi and Rinvoq, are more effective than Humira and can pass peak Humira sales in four years.

Continue to STAT+ to read the full story…

2 years 5 months ago

Pharma, Pharmalot, Pharmaceuticals, STAT+

STAT

STAT+: Amgen pricing for its Humira biosimilar may benefit PBMs and insurers more than patients

Underscoring the opaque and confusing nature of pharmaceutical pricing, Amgen announced long-awaited discounts for its biosimilar version of Humira — the world’s best-selling medicine — and the numbers suggest the biggest winners may be health insurers and others in the supply cha

Underscoring the opaque and confusing nature of pharmaceutical pricing, Amgen announced long-awaited discounts for its biosimilar version of Humira — the world’s best-selling medicine — and the numbers suggest the biggest winners may be health insurers and others in the supply chain, but not patients.

Here’s why: The drug company will offer its medication, called Amjevita, at two different discounts — 5% and 55% — off the roughly $80,000 wholesale, or list, price. The maneuver reflects the behind-the-scenes negotiations that occur between pharmaceutical companies and the pharmacy benefit managers, or PBMs, that create formularies, or lists of medicines for which insurance coverage is provided.

Continue to STAT+ to read the full story…

2 years 6 months ago

Pharma, Pharmalot, Biosimilars, Pharmaceuticals

Kaiser Health News

Part II: The State of the Abortion Debate 50 Years After ‘Roe’

The Host

Julie Rovner
KHN


@jrovner


Read Julie's stories.

The Host

Julie Rovner
KHN


@jrovner


Read Julie's stories.

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.

The abortion debate has changed dramatically in the seven months since the Supreme Court overturned Roe v. Wade and its nationwide right to abortion. Nearly half the states have banned or restricted the procedure, even though the public, at the ballot box, continues to show support for abortion rights.

In this special, two-part podcast, taped the week of the 50th anniversary of the decision in Roe v. Wade, an expert panel delves into the fight, the sometimes-unintended side effects, and what each side plans for 2023.

This week’s panelists are Julie Rovner of KHN, Alice Miranda Ollstein of Politico, Sandhya Raman of CQ Roll Call, and Sarah Varney of KHN.

Panelists

Alice Miranda Ollstein
Politico


@AliceOllstein


Read Alice's stories

Sandhya Raman
CQ Roll Call


@SandhyaWrites


Read Sandhya's stories

Sarah Varney
KHN


@sarahvarney4


Read Sarah's stories

Among the takeaways from this week’s episode:

  • Exemptions to state abortion bans came into question shortly after the Supreme Court’s decision to overturn Roe, with national debate surrounding the case of a 10-year-old in Ohio who was forced to travel out of state to have an abortion — although, as a rape victim, she should have been able to obtain an abortion in her home state.
  • The restrictions in many states have caused problems for women experiencing miscarriages, as medical providers fear repercussions of providing care — whether affecting their medical licenses or malpractice insurance coverage, or even drawing criminal charges. So far, there have been no reports of doctors being charged.
  • A Christian father in Texas won a lawsuit against the federal government that bars the state’s Title X family-planning clinics from dispensing birth control to minors without parental consent. That change poses a particular problem for rural areas, where there may not be another place to obtain contraception, and other states could follow suit. The Title X program has long required clinics to serve minors without informing their parents.
  • Top abortion opponents are leaning on misinformation to advance their causes, including to inaccurately claim that birth control is dangerous.
  • Medication abortion is the next target for abortion opponents. In recent months, the FDA has substantially loosened restrictions on the “abortion pill,” though only in the states where abortion remains available. Some opponents are getting creative by citing environmental laws to argue, without evidence, that the abortion pill could contaminate the water supply.
  • Restrictions are also creating problems for the maternal care workforce, with implications possibly rippling for decades to come. Some of the states with the worst maternal health outcomes also have abortion bans, leading providers to rethink how, and where, they train and practice.
  • Looking ahead, a tug of war is occurring on state and local levels among abortion opponents about what to do next. Some lawmakers who voted for state bans are expressing interest in at least a partial rollback, while other opponents are pushing back to demand no changes to the bans. With Congress divided, decisions about federal government spending could draw the most attention for those looking for national policy changes.

And for extra credit, the panelists recommend their most memorable reproductive health stories from the last year:

Julie Rovner: NPR’s “Because of Texas’ Abortion Law, Her Wanted Pregnancy Became a Medical Nightmare,” by Carrie Feibel

Alice Miranda Ollstein: The New York Times Magazine’s “She Wasn’t Ready for Children. A Judge Wouldn’t Let Her Have an Abortion,” by Lizzie Presser

Sandhya Raman: ProPublica’s “’We Need to Defend This Law’: Inside an Anti-Abortion Meeting with Tennessee’s GOP Lawmakers,” by Kavitha Surana

Sarah Varney: Science Friday’s and KHN’s “Why Contraceptive Failure Rates Matter in a Post-Roe America,” by Sarah Varney

Also mentioned in this week’s podcast:

Click to open the transcript

Transcript: Part II: The State of the Abortion Debate 50 Years After ‘Roe’

KHN’s ‘What the Health?’Episode Title: Part II: The State of the Abortion Debate 50 Years After ‘Roe’Episode Number: 282Published: Jan. 26, 2023

Tamar Haspel: A lot of us want to eat better for the planet, but we’re not always sure how to do it. I’m Tamar Haspel.

Michael Grunwald: And I’m Michael Grunwald. And this is “Climavores,” a show about eating on a changing planet.

Haspel: We’re here to answer all kinds of questions. Questions like: Is fake meat really a good alternative to beef? Does local food actually matter?

Grunwald: You can follow us or subscribe on Stitcher, Apple Podcasts, Spotify, or wherever you listen.

Julie Rovner: Hi, it’s Julie Rovner from KHN’s “What the Health?” What follows is Part II of a great panel discussion on the state of the abortion debate 50 years after Roe v. Wade, featuring Alice Miranda Ollstein of Politico, Sandhya Raman of CQ Roll Call, and Sarah Varney of KHN. If you missed Part I, you might want to go back and listen to that first. So, without further ado, here we go.

We already talked a little bit about the difficult legal situation that abortion providers or just OB-GYNs have been put into, worried about whether what they consider just medical care will be seen as an abortion and they’ll be dragged into court. But in Tennessee, doctors would actually have to prove in court that an abortion was medically necessary, which seems a bit backwards. So, basically, it’s do it, see if you get arrested, and then you’ll have to present an affirmative defense in court. But the other thing that we’re starting to see is doctors leaving states, women’s health clinics closing, medical students and residents choosing to train elsewhere. This could really lead to a doctor drain in significant parts of the country, right?

Sandhya Raman: Yeah, I was looking at before where some of the states that have some of the highest rates of maternal mortality, maternal morbidity, and just lower maternal health outcomes overall are some of the same ones that don’t have Medicaid expansion and also do not have access to abortion right now. And it’s one of the things where, looking ahead, there have been people sounding the alarm at how this is going to get amplified. And as folks that might be interested in this discipline that are in medical school, school or readying for residency, or another type of provider that works in this space, if they choose to not train in these states — and a lot of folks that train in states often end up staying in those states — even if there are changes in some of these laws in the near term, it could have a huge effect in the future in terms of who’s training and who’s staying there and who’s able to provide not just abortions, but other terms of pregnancy care and maternal care.

Sarah Varney: And the workaround has become much more difficult because it used to be that if you’re in a state where abortion was very difficult to access or even, say, Texas during S.B. 8, these medical students could go to other states for the training. But now that you have these huge swaths of the South and the Plains and the Midwest where they are not allowed to do abortions, there’s just not enough places for OB-GYN residents and medical students to go to train. I did a story about this last year as well and looked at these students who were in medical school, who were coming up to Match Day and at the end, at the very end before the deadline, actually changed their match altogether or changed their list of priorities altogether because they didn’t want to be in Texas. So instead of doing an OB-GYN residency in Texas, this one young woman changed to a family medicine practice in Maryland. And I think the thing that’s important for people to remember is that these are the future OB-GYNs that will help many of us with our pregnancies and births for many decades to come. And as we have seen, pregnancy is very complicated and it oftentimes doesn’t end well. You know, about 10% of all confirmed pregnancies end in miscarriage; a far higher number end in miscarriage that are not confirmed pregnancies. And these will be the doctors that are supposed to actually know how to do these procedures. So if you’re in a state like Texas and you have a daughter who’s 15 and you anticipate in 15 years she may want to have a baby, you have to think about what kind of medical care she can have access to then.

Rovner: I’ve talked to a lot of people, a lot of women, who want to get pregnant, who want to get pregnant and have kids, but they are worried about getting pregnant because if something goes wrong, they’re afraid they won’t be able to get appropriate medical care. They would like to get pregnant, but they would actually not like to risk their own lives in trying to have a baby. And that’s actually what we’re looking at in a number of these states. I guess this is the appropriate place to bring up the idea of “personhood,” the declaration, not medically based, that a separate person with separate rights is created at the moment of conception. That could have really sweeping ramifications, couldn’t it? They’re talking about that, I know, in several states.

Varney: Yes. You don’t have to probe far to find out that the pro-life movement is 100% behind a federal fetal rights … the Supreme Court last year didn’t take up a case about fetal rights yet, but many of the members of the court have expressed in previous writings, and even in the Dobbs [v. Jackson Women’s Health Organization] decision, you saw [Justice Samuel] Alito using the language of the state of Mississippi that essentially granted to the fetus all of the … even, like, personality of a full human being. So I think this is going to get really tricky because Kristan Hawkins and many of the leaders of the movement, Jeanne Mancini, they do believe that there is no distinction between a zygote and a fetus and a full human being. So now this is really a religious belief. And it was interesting. I really struggled last year. I had to … I was basically assigned to write a story about, you know, when does life begin? And I think it’s an interesting question we have to ask ourselves as journalists: Why should we do that story? Is that, in a sense, propaganda for the pro-life movement? When really what the question should be is, you have a full human being, the woman, at what point should her rights be impeded upon? Right? And that’s essentially what the Roe decision tried to do, was to strike that balance. But now we’re in a whole new world where fetal rights are really the … they almost have supremacy over women’s rights.

Rovner: Yeah, I did two stories on When Does Life Begin? And it turned into one of them is … really the question is when does pregnancy begin? One of the doctors I talked to said, rather, that pregnancy begins when we can detect it, which is in many ways true. A doctor can’t say that you’re pregnant unless they can detect it at that point. But that’s a really important distinction medically between, you know, when does life begin philosophically and when does a pregnancy actually begin. But, obviously, in places that are going to declare personhood, this is going to get really complicated really fast because it would mean that you mostly couldn’t do IVF, that you can’t create embryos and then not implant them. And of course, the way IVF works for most people who are infertile and would like to have children is that you take out the eggs, you fertilize them, you grow them to a certain cell size, and then you implant them back into the woman. But you don’t generally use all of the embryos. And that would be illegal if every one of those embryos was an actual person. Could you take tax deductions for children if the child hasn’t been born yet, but you’re pregnant? I think you can already do that in Georgia, right?

Varney: Correct. Yeah. The Department of Revenue did that there.

Rovner: Yeah. This could be really, really far-reaching.

Varney: I mean, that’s what’s been going on in Alabama for years. … When the Alabama state Supreme Court years ago agreed with this argument that a law that was put in place to try and go after parents who were bringing their children to meth labs, that the notion of the environment was no longer just the meth lab, but the womb itself. And a child also then meant a fetus in the womb. Now you’re in that territory already. So Alabama’s a very good way to look into the future, in a sense.

Rovner: So basically, if you’re pregnant and go into a bar, you could be threatening the fetus.

Varney: I mean, there’s kind of no limit, right? Like, did you drive recklessly? Did you slip or did you fall on purpose? I mean, that’s what I was saying earlier about it’s really going to be up to these local prosecutors to figure out how far they want to take this.

Rovner: And that’s not hypothetical. We’ve seen cases about a woman who fell down the stairs and had a miscarriage and was prosecuted for throwing herself down the stairs.

Varney: Or a woman who was pregnant and got into an altercation in a parking lot of a big-box store and got shot and the fetus died. And then she was arrested. I mean, eventually they dropped the charges, but. yeah.

Rovner: Well, moving on. So with narrow majorities in both houses of Congress for the party in charge, changing federal law in either direction seems pretty unlikely for the next two years, which leaves the Biden administration to try to reassure people who support abortion rights. But the Biden administration doesn’t have a long list of things that can be done by executive action either, beyond what they’ve done with the abortion pill, which we mentioned already — the FDA has loosened some of those restrictions. How has the Biden administration managed to protect abortion rights?

Alice Miranda Ollstein: First, along the lines of the FDA, the FDA has been called on by the pro-abortion rights side to drop the remaining restrictions on the abortion pill. So they’ve dropped some, but they still require a special certification for the doctors who prescribe it, a special certification for the pharmacies that are just newly allowed to dispense it. Patients have to sign something saying they understand the risks. These are called REMS. These are on drugs that are considered dangerous. And a lot of medical groups and advocates argue that there isn’t evidence that this is necessary, that the safety profile of these drugs is better than a lot of drugs that don’t have these kinds of restrictions. And so they said that it would improve access to drop these remaining rules around the pills. Some have even called for them to be available over the counter, although I don’t see that happening anytime soon. Along the lines of preventing unwanted pregnancies in the first place, the FDA also is sitting on a decision of whether or not to make just regular hormonal birth control available over the counter. So that’s one to watch as well. But the Biden administration have more things they could do. They have looked at providing abortions through the VA [ Department of Veterans Affairs]. That was a big one. Earlier this year, the president signed a memo just over the weekend directing the health secretary and others in the Cabinet to look at what they can do to improve access. We’ve seen similar statements and memos before. It’s not really clear what they’ll mean in practice. But I also want to go back to you saying that nothing is likely to happen in Congress. I agree on the legislative side, but I am watching closely on the appropriations side, because I think that’s where you could see some attempts to pull things in one direction or another in terms of where federal spending goes. And going back to the group’s wastewater strategy, one piece of that they want to do, the anti-abortion groups, is pressure Republican members of Congress to hold the FDA’s funding hostage until they do certain environmental studies on the impacts of the pills. That’s where I would watch.

Rovner: Yeah, and spending bills over the years have been the primary place to do legislating on abortion restrictions or take them off. It’s not just the Hyde Amendment that banned most federal spending for abortion. There are amendments tucked into lots of different spending bills restricting abortion and other types of reproductive health care. And when Democrats are in charge, they try to take them out. And when Republicans are in charge, they try to put them back in. So I agree with Alice. I think we’re going to see those fights, although it’s hard to imagine anything happening beyond the status quo. I don’t think either side has the ability to change it, but I suspect that they’re going to try. The administration has gone after some states on the federal EMTALA law, right? The Emergency Medical Treatment and Active Labor Act, which basically says that hospitals have to stabilize and take in women in active labor. And basically, if that conflicts with an abortion ban again, like with the FDA and drugs, federal law should supersede the state law. But we haven’t really seen any place where that’s come to a head, right?

Raman: Idaho has been the main one to watch with the lawsuit there. And the Justice Department did a briefing this week before their reproductive rights council met. And they had said that that was one of the cases they’re still doing — the Idaho, in addition to the lawsuit on the VA rule that Alice mentioned, and then also an FDA rule that we talked about earlier. But they’re monitoring different things going forward. But I think one of the interesting things is that they haven’t cast a very huge net in terms of the different things that they’ve been involved with in states. It’s mainly been these three situations. And even Idaho, they’ve already in that legislature introduced a bill that would amend their law as it is now, to deal with some of the nuances so that they would adhere to EMTALA. I don’t know how far that could go through or any of the logistics with that, but I mean, that sort of thing, the Idaho situation could be solved more quickly if they’re able to get that done. And DOJ [the Department of Justice] thinks that that aligns. But it is interesting that they haven’t dug into a lot of the other state efforts yet, but that they have that on their radar.

Varney: We have seen a sort of political battle being waged, of course. So on the anniversary of Roe v. Wade, Vice President Kamala Harris was in Florida, in Tallahassee, making the 50th-anniversary-of-Roe speech. Clearly, she wants [Gov. Ron] DeSantis to be on notice that should he become a candidate in the presidential election, that Florida is very much in play. And Florida is interesting because they still have a 15-week ban. So it would not have been allowed under Roe, but it’s not as draconian as what these other states have, which is essentially nothing.

Rovner: Most of the surrounding states, too.

Varney: Correct. Yeah, exactly. So Florida has really become a receiving state for abortions, particularly in the last six months. I’m going to be interested to see if somebody like a DeSantis can even run for president from a state with a 15-week ban. I mean, he’s going to be under a lot of pressure, not simply just to do a six-week ban, but to do an outright ban altogether. So I think if he tries to thread that needle and try and get anti-abortion groups on board to support him, he’s going to have to show them more.

Rovner: That’s just about what we’re going to get to. But before we leave, what the Biden administration has done, I need to mention, because it’s my own personal hobbyhorse — that the FDA has finally come out and changed the label on the “morning-after pill” to point out that it is not an abortion pill, that it does not cause abortion, that the way it works is by preventing ovulation. So there is no fertilized egg and that at least we can maybe put that aside, finally. That label change happened in Europe 10 years ago, and for some reason it took the FDA until now to make that clarification.

Varney: But as you said, Julie, it doesn’t matter because it’s just what you believe about the drug. You know, and just to remind listeners that that drug I did — I mean, we’ve all done stories on Plan B over the years — but the one I did recently was how Plan B is actually owned by a private equity company, actually two private equity companies. And they would not go to the mat to the FDA to get this thing changed. They could have done it years ago. So now that the FDA has made this … it’s just like anything, any kind of misinformation, that people who don’t support it can just simply say, well, the FDA is biased or that’s not actually how it works.

Rovner: True.

Varney: But I don’t think it will put it to bed.

Rovner: Well, quickly, let us turn to 2023 and what we might see for the rest of this year. We’ll start with the anti-abortion side. Obviously, overturning Roe was not the culmination of their efforts. They have some pretty ambitious goals for the coming year, right? Things like travel bans and limiting exceptions in some of these states. Sandhya, I see you nodding.

Raman: There are so many things, I think, on my radar that I’m hoping to watch this year just because we are in this whole new era where it might have been three years ago a lot easier for us to predict which things might be caught up in litigation, which things might be struck down. But I think now, after the Dobbs decision, even after the Texas S.B. 8 law that we mentioned earlier, it’s a lot more difficult to see what sort of things will go in effect that might not have been able to go into effect before. And one thing I think has been interesting is that the anti-abortion movement had been in unison before this on some of their traditional Hyde exceptions — that abortions to save the life of the mother, in cases of rape and incest were something that was broadly on board, that those would be allowed. And I think we’ve seen a lot increasingly in different states, things that have been brought up by different state lawmakers that would chip away at that, that vary by state, whether or not what defines is medically necessary to save a life. And even when we were talking about Idaho earlier with the EMTALA requirements or … there was a great piece in The New Yorker last year about the anti-abortion activist who really wants to lobby against rape exceptions because she was born as a product of rape and is using her own experience in that. And so I think that will be a very interesting thing to watch because there is not a uniform agreement on that. Whereas some of the things that have been taken out, there’s a lot more strong backing for across the board.

Rovner: Yeah, that’s actually my next question, which is we’re starting to see not only a split within the anti-abortion community about what to pursue, but a little bit of distance between the Republicans and the anti-abortion forces. And I think there’s a lot of Republicans who are uncomfortable with going further or who are uncomfortable even in some of the states that don’t have exceptions. I mean, are we looking at a potential breakup of this Republican anti-abortion team that’s been so valuable to both sides over the last few decades?

Ollstein: I wouldn’t call it a breakup, but the tension is absolutely there. I mean, I wouldn’t call it a breakup just because, where else are they going to go? I mean, the Democratic Party is much more supportive of abortion rights as a whole than even just a few years ago. And so, really, they know Republicans are their best bet for getting these restrictions passed. But there is this interesting tension right now. I think a lot of it is competing interpretations of what happened in this most recent election. You have anti-abortion groups who insist that the takeaway should be candidates didn’t run hard enough on banning and restricting abortion and were too wishy-washy, and that’s why they lost. And then you have a lot of other Republicans and party officials, party leaders who feel that they were too aggressive on promoting abortion restrictions and that’s why they lost. Also, you know, I will say this isn’t purely, purely cynical politics. A lot of Republican state lawmakers have told us they’re genuinely concerned now that they’re actually seeing the laws they drafted and voted for take effect and have consequences that they maybe didn’t intend. And they’re hearing from these state medical groups who are pleading for changes to be made. And so some of them say, OK, we want to get this right. We want to go back and make fixes. And the anti-abortion groups are telling them, no, don’t create loopholes. Don’t water down these laws. And so you do have this really interesting tug of war playing out at the state level right now. And because of what you said about the federal level, the state level is really where it’s at.

Varney: And I was going to make two points. One is that the split is also really developing between the national groups and the state and local groups. So while the national groups may say, yes, we support a 15-week ban in Florida as a step to get to something else, the local groups are gung-ho. I mean, they’re in extremely gerrymandered districts. You look at Florida and Texas, they elected the most anti-abortion state legislature in history so far. And, you know, these are people coming from extremely safe seats. And then you’ll see that the city level — the city sanctuary of the unborn, I believe it’s called — that movement, they really see them going down to even the local-local level to try and get that in effect.

Rovner: Well, I think in a lot of places, states that are very affirmatively supportive of abortion rights or have it in their constitution, are trying to move that down to the local level, to the city level, to see if they can actually have success in limiting abortion locality by locality. All right. Well, meanwhile, what’s the other side doing? What’s the agenda for the abortion rights side? It’s going to be, as we pointed out, it’s gonna be kind of hard for them to advance very much.

Ollstein: Yes. I think that there is a lot of excitement around the results last year using state-level ballot initiatives in red and purple states, putting the question of abortion rights to the general public, because on all six ballots last year, the abortion rights side prevailed. Some of those were more offensive, some of those were more defensive. But in all six, they swept. And so they are really excited about trying to replicate that this year. Of course, it’s not possible in every state to put a constitutional amendment on the ballot for a popular vote. But in states where it is possible and where it could make a difference, including some states where abortion is already banned and they could try to unban it through the popular vote process, that’s really something they’re looking at. And then, of course, even though our federal judiciary has become a lot more conservative over time with the appointments, courts have still been convinced to block a lot of these state abortion restrictions. And so there are efforts to bring lots of different, interesting legal theories. You know, one that caught my attention is trying to make religious freedom arguments against abortion bans, saying these abortion bans infringe on the rights of religious people who believe in the right to abortion, which is sort of flipping that narrative there.

Rovner: There have been a bunch of Jewish groups who have filed cases saying that.

Ollstein: Exactly. Judaism, Islam, certain Christian denominations, all support abortion rights. And so there’s an interesting tactic there. Also pointing to language in state constitutions about privacy rights and arguing that should extend to abortion. And so a lot of interesting stuff there.

Raman: I would add to that, in terms of another tactic that’s kind of flipping what the other side has been doing, a long-term strategy of the anti-abortion movement has been prioritizing judicial elections and a long-term thing of … just in the Senate, we saw, you know, wanting to get a lot of judges confirmed that had pro-life beliefs. And you can even look to where the women’s march over the weekend, that the state … one that they were prioritizing was in Wisconsin, which was held there, to jump-start the fact that they have a state Supreme Court race coming up. They were 4-3 conservative majority right now. And the judge that is retiring is conservative. So getting a new judge that supports abortion rights could really open a path to overturn the ban there. Even though judicial elections are considered nonpartisan, there are often ways to tell clues about where someone might rule in the future. And so, I think, looking at things like that in different states as a way to dial back some of the things that the other side has been doing will be an interesting thing to watch, too.

Rovner: All right. Well, I think that’s it for our discussion. Thank you, for those of you who have hung with us this long. I hope we’ve given a good overview of the landscape. Now it’s time for our extra-credit segment. Usually that’s when we each recommend a story we read this week we think you should read, too. But this week I’ve asked each of the panelists to choose their favorite or most meaningful story about reproductive health from the last year. 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: Yes, I think I’ve promoted this story before, but I just can’t say enough good things about it. It’s really stuck with me. It’s from the New York Times Magazine by Lizzie Presser, and it’s called “She Wasn’t Ready for Children. A Judge Wouldn’t Let Her Have an Abortion.” And it really digs into what happens to teenagers who need to get their parent’s consent and can’t in order to have an abortion. They have this judicial bypass process where their lives, the fate of their lives are in the hands of an individual judge, who, in many cases, as this article demonstrates, come with their own biases and preconceptions about abortion. And then it just follows this one teenager who was denied an abortion, ended up having twins, and just completely struggled financially, her mental health. And she in the end said, you know, I knew what was right for me. I knew I needed an abortion. And it’s a very moving, painful story that shines a light on a piece of the story that I think is overlooked.

Rovner: Yeah. Sandhya.

Raman: For my extra credit, I picked a story that also has stuck in my head for a long time, kind of like Alice. So it’s “‘We Need to Defend This Law’: Inside an Anti-Abortion Meeting with Tennessee’s GOP Lawmakers,” from Kavitha Surana from ProPublica. I really thought this was one of the most interesting pieces on this topic that I read last year. The author got audio from a webinar in Tennessee hosted by the Tennessee Right to Life on strategy on the movement going ahead in their state. They talk a lot about the Tennessee ban and how it has narrow life exceptions as a model for other states and how the burden of proof would be on the doctor. And then they have some quotes from a Tennessee lawmaker who suggests things that I think the other side has sounded the alarm about: mining data to investigate doctors, how to push back against rape and incest exceptions. And I think one of the things that really struck me was when they brought up IVF, some of the advocates during the meeting that they had said that two years from now, next year, or three years from now, IVF and contraception can be regulated on the table. But that’s like next steps.

Rovner: Absolutely. That was a great scoop, that story. Sarah.

Varney: So I actually picked a radio segment. It’s about a 12-minute-long radio segment that I did with Science Friday. On “Why Contraceptive Failure Rates Matter in a Post-Roe America.” So one of the things I kept hearing was, well, women are just going to have to really double up on contraception or make sure that they’re being responsible about taking their contraception. So it turns out that there’s a textbook on contraceptive technology and in that is a whole page on contraceptive failure rates, which show you what contraceptive failure rates should be in a laboratory and what they are actually out in the real world. So, for instance, the typical-use failure rate for birth control pills is 7%. So that means that seven out of 100 women on pills could experience pregnancy in the first year of use. So then I went and found the data that shows us the number of women ages 15 to 49 who are on specific methods of birth control, everything from the Depo-Provera to the contraceptive ring and patch to male condoms, to IUDs, to birth control pills. And you’ll see on both the Science Friday and the KHN website, we have these wonderful graphics where you can see that in one year of people using male condoms, because of their failure rate is about 13% in the real world, that could lead to up to 513,000 wanted pregnancies. Birth control pills, based on the number of women using birth control pills, up to 460,000 pregnancies a year in people who are actually using contraception to not get pregnant. So I think these data visualization is really important. And you can hear interviews that I did with the researcher and the physician who actually is the author of this textbook, as well as one of the world’s leading reproductive endocrinologists who talks about what’s next in contraceptive efficacy.

Rovner: Yes, I loved that story. Well, my story is also a radio story. It’s from NPR by Carrie Feibel. And it’s called “Because of Texas’ Abortion Law, Her Wanted Pregnancy Became a Medical Nightmare.” And it’s from July. And the events that it chronicles happened before the overturn of Roe v. Wade, because, as we’ve said, Texas’ abortion ban was already in effect. By now, we’ve heard this story many times. A woman with desired pregnancies, water breaks prematurely, which would normally result in a quote-unquote “medical termination.” Except the doctors and hospitals aren’t sure how sick the mom needs to be before the pregnancy actually threatens her life. And any other abortion is illegal, and they could get in legal trouble. So they put her through days of hell and sickness before she starts to show signs of sepsis and just before she and her husband were actually going to fly out of the state to get the pregnancy terminated. But this was the first of these stories that I read. And it hit me very hard. And I have such respect for the couple here who were willing to come forward and publicize all that the women called these gray areas of abortion, which lawmakers often think of as black-and-white. It was just one of those stories that sticks with you.

All right. 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 — all one word — @kff.org. Or you can tweet me. I’m @jrovner. Sandhya?

Raman: @SandhyaWrites

Rovner: Alice?

Ollstein: @AliceOllstein

Rovner: Sarah.

Varney: And @SarahVarney4

Rovner: Will be back in your feed with our regular news rundown next week. Until then, be healthy.

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