Navigating Uncertainty and Unprecedented Shifts in Federal Health Policy

0:00The way science works, of course, is through learning the accretion of evidence, the study of evidence, which often leads us to change our conclusions about things like how does a pathogen spread in the population? How dangerous is it? That is science working well. But particularly during an emergency like a pandemic, that is not really what people want to hear. They want to hear that somebody is taking care of things, knows what to do and is doing it. Perhaps that is why pandemic-era health officials were very confident in their pronouncements about things like the efficacy of the COVID vaccine in preventing infection or whether we did or didn't need to mask.

0:45That made it difficult for them to later amend their recommendations when we learned more.

0:55This is Stanford Legal, where we look at the cases, questions, conflicts, and legal stories that affect us all every day. I'm Pam Carlin. Please subscribe or follow the speed on your favorite podcast app. That way you'll have access to all of our new episodes as soon as they're available. Well, probably no part of our lives is more touched by the federal government in some ways, then our health. The federal government regulates the drugs we use. The federal government regulates the kinds of insurance through the Affordable Care Act. And the federal government has all sorts of public health policies and the like.

1:32And we're seeing a huge number of changes here. So we are incredibly lucky that today the guest on the podcast is my colleague, Michelle Mello, who is a professor both at the law school and at the medical school here at Stanford. So So thanks so much for joining me, Michelle. Thanks very much for having me. Yeah, so we've had a lot of secretaries of health and human services over the course of that department since it split off from the old health education and welfare department. But I don't think we've ever had one quite like our current secretary. Can you give us a little bit of a sense of just how seismic the changes have been here?

2:12Well, it's early days still. So it's hard to say where we're going to land. But the amount of chaos, I would say, is the word that has been introduced into the federal health policy landscape by the secretary in the first several months, I think is really unprecedented, both in the types of things substantively that have been done and in the way they have been done. Yeah, I think that, you know, sometimes they say personnel is policy. And here we've seen some really huge changes in personnel, not just kind of political appointees like the secretary or the deputy secretary or the various people who are presidential appointees, but also changes in personnel at the career level as well.

2:59Can you give us a little bit of a sense of what you're seeing there? Yeah, I mean, this is one of the things that really makes me the saddest when I think about what has changed in health policy over the last nine or 10 months. It's just the enormous well of expertise that has led the federal health response for decades in the civil service has been hollowed out. These are career scientists from the hard sciences as well as the social sciences, folks who have deep, deep subject matter expertise in really technical health policy issues like reimbursement for the Medicare program or the way in which people layer on different kinds of subsidies to buy their health insurance or the ways in which vaccines are procured and supplied to states.

3:50gone and the remaining personnel really deeply demoralized. And when you think about the amount of expertise that is required to run these health programs well and efficiently and without waste, it really makes me fairly despondent. Yeah. And we're kind of seeing this across the government. I mean, I see it obviously from the Department of Justice angle, which is the same kind of thing. There were people who were experts on all sorts of statutes you've never heard of, but they understood how the Federal Tort Claims Act worked or how the Vacancies Act worked or the like. And some of these people are being fired and others of them are resigning or taking these fork in the road early retirements or the like.

4:37Do you have a sense of how much of it is people leaving because they can't do the work anymore that they came to do? It's not so much that, at least not yet. I think it is primarily people being laid off or fired or told that their services are no longer required. And that goes for external experts like the professors and others who serve on the Advisory Committee on Immunization Practices, for example, as well as civil servants. Yeah. And this immunization one has been, I mean, I've kind of followed it in part because I'm at the age where you're supposed to get the COVID vaccine still and the like.

5:18And I was very nervous that I wouldn't be able to go and get the vaccine because it wasn't going to be available. And I think it might be useful for our listeners for you to explain a little bit of how, why it matters what the vaccine committee says about which vaccines which people can get and kind of its relationship to people's insurance and the like. Yeah, so this is an independent advisory committee. It is advisory. It is advisory to the Centers for Disease Control and Prevention, the CDC, and it is composed of volunteers who historically have been deeply respected scientific experts, primarily from academia.

6:00And they give very generously of their time to evaluate issues about which vaccines and vaccinations should be recommended for children and adults in the United States. And that's always been somewhat controversial work because there has always been a segment of the U.S. population, albeit a small one, that has resisted having vaccines required. But of course, during COVID, their work became very much more in the public eye and the subject of much resistance because they made decisions about who would have access to the COVID vaccine and in some respects, which groups were important enough to receive it that states and employers ought to consider requiring it.

6:44They don't make decisions about vaccination mandates, but many states use their recommendations as the basis for the mandate decisions that they make. What's really important from an access perspective is that ACIP-recommended vaccines must, as a condition of the Affordable Care Act, be covered by insurers without a copayment. So at the point of care, the patient is not billed for the vaccine. During COVID, that was not such a big deal because COVID vaccines were subsidized by a separate line of funding. But for childhood vaccines, which can get very expensive, it is really critical that insurance coverage be maintained.

7:25So the concern was that once ACIP changed its recommendations, insurance companies would start changing their coverage. Thankfully, if there is a silver lining to the fact that the new members of ACIP are not particularly well qualified, it is that the insurers have rejected the opportunity to stop covering vaccines based on that group's new set of recommendations. Yeah. I mean, when I went to get my COVID vaccine, I asked them, you know, what's going on? And they said, look, we're not requiring that people show they're 65. We're just giving this to anybody who's got an insurance card and comes in.

8:01Yeah. And I guess you're pointing to a separate issue, which is who can access the vaccines, quite apart from whether you would be willing to pay a copayment for them or not. For a while, there were real concerns that because a separate process of rolling back FDA coverage approval for vaccines was going on, that there might literally be difficulties for people showing up pharmacies to get vaccines. Fortunately, one aspect of the current chaos has been that that seems to have dissipated a little bit, that fear. It seems to be the case that now the administration has defined this narrative that vaccines will be available subject to, quote unquote, shared decision making, broadly enough that that includes just about anything, including probably what you experience when you walk into your pharmacy, which is that the pharmacist says, do you have any questions?

8:49And you say, no. And they say, OK, Pam, here's your vaccine. Yeah. And you've written recently about with all this chaos in Washington and the kind of fall off of professional expertise at HHS, state public health departments are going to have to step up in a bunch of ways if we're going to continue to protect Americans' health. Yeah, and vaccines are just one example of that. The way that it's playing out now for vaccines is that we have this new ACIP whose findings, I think is fair to say, are not respected or regarded as evidence-based by people who know, by experts. And so one thing that has been called into question is whether the CDC itself will continue to base its recommendations on the advice of this committee, as it historically nearly always has.

9:42That question was what led to the firing of Dr. Susan Menara, the head of this. She got fired like a week or a month. It was about a month, a little over a month on the job. Yeah, she managed to go from being eminently well-qualified in the view of the secretary to untrustworthy. So one issue is whether the CDC will do what ACIP says, but then a separate issue is, will others follow the advice of the CDC? Both during the Biden administration and during the first Trump administration, there were many in the United States who felt that they could no longer trust the advice of the CDC because it didn't align with their own perceptions of what the right thing to do was, and that they felt that the agency under whatever leadership it was currently under was untrustworthy.

10:30It couldn't be trusted to follow the science. And so there had already been this, I think, destabilization of public trust in CDC. We have survey data that bear that out. And so what does this all mean for states? It means, I think, that there is a wellspring of demand for guidance from outside of Washington and Atlanta now. and states to some extent are starting to fill that gap. And in particular, many of the Western states have now come together in an alliance to make their own recommendations about vaccinations as essentially a shadow CDC, that they are going to do what the CDC no longer seems to be able to do, which is to follow the evidence and make recommendations.

11:13Then on the other hand, we have certain states going very much in the other direction and just saying from vaccines, no, thank you. Yeah, that was what I was gonna ask you is like, you know, there are reports that some states are going to get rid of vaccine mandates for kids in schools, you know, and I would assume that that will be followed relatively quickly thereafter with an outbreak of measles or an outbreak of whatever else the chickenpox or whatever the kids aren't being vaccinated on. Yeah, we will see. I mean, what has happened is that the Florida Surgeon General has said that the Florida will be ditching requirements for school entry vaccines.

11:48Now, the Florida Surgeon general doesn't have authority to do that and then has to be done. So is it like each school district decides? No, no, but it is typically through legislation in Florida. I honestly don't know how much of it is through legislation versus formal rulemaking, but it is not done by any one individual. It's done through a process. So, but assuming that that process follows, then vaccines effectively become optional. It's important to remember that even in Florida, most parents understand that getting your kids vaccinated is a good idea. And so even those who object to being required to do so may well come forward and do so, perhaps not fully or on the schedule that public health officials might like.

12:29But I don't think we're going to see plummeting rates of school entry vaccination. But to your point about measles, the difficulty is for some of these very highly infectious diseases, it doesn't need to plummet. It just needs to dip a little bit before we lose what's called our herd immunity. You know, there has to be a certain percentage of the population that has immunity either through having been infected with the disease or through vaccination. And for measles, because it is so infectious, that number is very, very high, around 95%. Wow. So the more we see of this kind of dislike of science or distrust of science and the kind of ma-ha, ha-ha-ha movement.

13:11What is driving this huge distrust of science? I mean, we're seeing it even at the Supreme Court in a way. There were, you know, last year in the Scrimetti case, there was a concurrence that said, why should we trust doctors at all on gender-affirming care, which is obviously, I think, even more controversial in some ways than the vaccinations. But we seem to have like across huge parts of society that used to have a great deal of respect for or deference to scientific expertise, medical expertise. We're seeing a drop off there. What accounts for that? You know, I think we're still trying to understand that fully.

13:52But the narrative that makes sense to me when I look at the polling data has to do with a misapprehension of the way scientific knowledge evolves and changes over time, coupled with, quite honestly, probably some degree of hubris on the part of Biden-era health officials about their own confidence in their pronouncements. So let me unpack that a little bit. The way science works, of course, is through learning the accretion of evidence, the study of evidence, which often leads us to change our conclusions about things like how does a pathogen spread in the population? How dangerous is it? That is science working well, but particularly during an emergency like a pandemic, that is not really what people want to hear.

14:43They want to hear that somebody is taking care of things, knows what to do, and is doing it. Perhaps that is why pandemic era health officials were very confident in their pronouncements about things like the efficacy of the COVID vaccine in preventing infection or whether we did or didn't need to mask. That made it difficult for them to later amend their recommendations when we learned more about the efficacy of the vaccines, what vaccines were really good for and what they were less good at and how we should think about risk benefit overall, as well as things about transmissibility, which changed recommendations around masking, around how social distancing, and lots of other things.

15:29But again, when you have like come out hot with a lot of confidence in your pronouncements in response to the public's, I think, demand that it look like somebody's taking care of things, it's hard to backtrack. And so I think this sort of anger and fear around recommendations changing permeates out into science generally, into a feeling that it can't be trusted because if it was right yesterday, shouldn't it be right tomorrow? And if people are quote unquote, like flip-flopping on policy decisions, how do we really trust the science? Maybe there's something else going on. Like maybe they've changed their minds due to political forces.

16:07So it all serves to kind of undercut the whole basis through which evidence-based policy is made, which is that you're supposed to have this openness to learning that you were wrong. Yeah, I think also just people's scientific literacy has not been a focus of K-12 education in the last 20 years. the teaching to the tests of kind of reading and just basic math, maybe have kind of led people not to understand scientific methods, not to, you know, not to talk about the history of science or the history of medicine in some ways, that would give them more of a sense that changing your hypothesis after seeing what's happened is not a sign that your original hypothesis was evil or stupid.

16:58It's just a sign that we now kind of know more than we did before. Yeah, that's an interesting hypothesis. I think even if you did get that kind of messaging when you were, you know, 16, it may be hard to remember that. Well, yeah, it might be like the vaccines themselves. It kind of wears off after half of time. Particularly when you're being bombarded with very different messaging from certain mainstream media outlets or from social media, which is, you know, very condemnatory of moves to change one's mind about scientific matters. And I think, you know, to some extent, we see the same kind of reaction going on in the Supreme Court's, you know, ruminations on when physicians change their minds about things.

17:45I mean, in both the Scrimetti case and the case this week about conversion therapy, there were concerns that how can we sort of rely on medical consensus as the lodestar? Because can't we think of instances where the whole profession was just wrong in a really big way about something? And of course, we can. And again, that I mean, I personally would want to live in a society where when we're wrong, we change practice. We move to better evidence-based practice. But it does give people, policymakers, judges, pause in announcing policies and rules that are pinned to the consensus of so-called experts because they acknowledge now that there's instability even in things that are, quote unquote, evidence-based.

18:35It's interesting because in addition to obviously all of your expertise on law and medicine, you also teach torts. And there, the standard of care in medical malpractice cases changes over time, and we don't seem to have a problem with it changing over time. That is, the fact that 40 years ago, a treatment was thought of as either something you had to do or something you should never do, and today we have a different view. We don't have trouble there. The common law system seems to be capable of adjusting to changes in medical knowledge in a way that we seem not to be able to do when it comes to kind of statutes.

19:17Yeah, I think that's right. And I guess if there's one advantage to litigating your issue in a courtroom, it's that you only really need to convince six to 12 people that you're right. You don't have to deal and be buffeted by all kinds of other information streams from outside and from the huge diversity of public concerns and experiences and biases that people bring to their assessment of different health threats. Yeah. So, I mean, do you think this is a moment of any kind of opportunity or is this just a moment of threat? I mean, it's hard to work in this field and see it as much more than a moment of threat for so many reasons, including reasons we haven't talked about around, you know, funding of science.

20:00But I think with this shift in leadership in public health from the federal to state level does come certain interesting opportunities around learning. You know, this famous judicial quote about the states as laboratories really comes to mind when we see, for example, now states moving in very different directions in vaccination policy or other things. You know, from a public health perspective, that is bad. We think we kind of know a few things about what is good for public health and states are going in very different directions with respect to these things. From a research perspective, it's great because what you want is a lot of variation in policy.

20:41that gives you things that you can statistically exploit for learning. So when we see things trending in Florida now in a very different way than in California, we will have a good hypothesis that it has something to do with vaccination policy and we'll have much better data with which to study it. So it's possible that from this two tracking, I would say, of public health policy in red and blue states will come some better evidence about what really is working and is not. And not just for vaccines, but for other things like fluoridated water. Not that we need necessarily another study to tell us that fluoridated water is helpful.

21:17Yeah, I mean, if you've seen Dr. Strangelove, you know all about fluoridation of the water. Yeah. Vital bodily fluids and things. It does give us an interesting opportunity to learn more about it. You know, I think there's also interesting opportunities to strengthen regional compacts among states. That has long been a thing in public health, but not a big thing. You know, the idea that states would form these alliances ahead of a crisis that would pre-position them to be able to work together and collaborate during a crisis. And we didn't really see that working all that well during COVID. For example, states were not sharing resources or expertise across lines.

21:58But, you know, with things like this Western States Alliance around vaccines, you know, who knows, maybe these states will develop structures and information sharing mechanisms that will make them better at combating other threats together in a way that makes them more successful than they would be individually. So I want to go back to something you said, which was about the funding and talk about the changes in science funding that we've seen since the new administration has come in. And there have been a series of cutoffs to various universities, either targeting particular universities or targeting particular kinds of science, particularly science that seems from the Trump administration's perspective to be too much about diversity, equity and inclusion.

22:50So studies that are studying racial differences in take-ups or the like. How much of a long-term effect is what the administration is now doing going to have? I think it's going to have a very long-term effect in particular areas. So areas where research has essentially been shut down, like mRNA vaccine research, or really any research that has to do with differences in health outcomes among people of different races and ethnicities. I think it takes a long time to rebuild that. in talking about how he would like to have, quote unquote, pause for eight years from certain lines of scientific research.

23:31Secretary seems to envision that you can just sort of walk out of a science lab, turn the lights out and come back eight years later, dust the machines off and boot everything back up. But of course, science doesn't work that way. We will lose the talent, both our young trainees who would otherwise be coming to train here in part because they could no longer get visas, even if they did have the funding. And we will lose faculty talent as well. For people who were in those lines of business, they will have to be in other lines of business, they will continue to stay in those lines of business, or they may leave the country altogether.

24:04So we're talking about a generational loss in our science talent pipeline in these particular areas. In other areas, I think it's, you know, it's more of a dent. And I will say the research community is resilient. We are used to sort of peaks and troughs in the availability of funding in different areas. And fortunately, there are other alternative funders that have stepped forward in certain areas to fill gaps. There is also the possibility of reconceiving or reframing research in ways that match the administration's current priorities. But overall, it is a very bleak landscape and one, again, that can't be repaired overnight.

24:51Yeah. And as I was kind of suggesting a moment ago, there's the targeting of particular research or particular researchers, but then there's also these attacks on universities more generally in which science seems to be almost like collateral damage to the administration's desire to punish particular universities, not because of the science they're doing at all, but because of allegations, for example, about anti-Semitism in the failure to deal with some of the demonstrations that followed on the Hamas attack on Israel and Israel's invasion of Gaza. Yeah, I mean, in that respect, the science part is just the lever.

25:35It's not the cause. It's that our dependence on the federal government for scientific research funding is the club that is being wielded to accomplish other policy goals. And it is a very powerful weapon. Our dependence is enormous. And, you know, it is generally thought that that investment produces huge returns for the public. So the public will lose ultimately from this foray. But you're quite right to point out that science is kind of the victim of something that is being motivated by something else. Yeah. And it's also that at least the courts, you know, going to court on this stuff turns out not to be quick and decisive and easy at all.

26:21I mean, some of the some of the cutoffs, you know, organizations are being told you went to the wrong court. You should go to one court to argue that the rule is unconstitutional or violates the Administrative Procedure Act. But if you actually want to get your money, you should be going to the Court of Claims rather than to the local district court. And, you know, I feel for the people who are trying to figure out how you challenge cutoffs of funds that were already given to people. That is, we're not even talking about next year's grants yet. We're still talking about the grants that were already made and that people had every reason to expect the money was going to, the money they'd been awarded was going to flow to them.

27:07Yeah, it does feel a little bit like trying to nail Jell-O to the wall. And that is honestly what it has felt like to come to work in a medical school for the last nine months, that it's like every day seems to be some new twist on the previous day's disappointment slash horror. Yeah, there's always some new iteration of the problem that has to be attacked in a slightly different way. I will say, though, I do have optimism about the courts here. I don't share the cynicism of some that judges can't see the difference between legal and illegal conduct if they have a certain political valence. And I actually think that many of the signs from the lower courts are very encouraging and even reassuring as to how these battles will end up in the long run.

27:54The trouble is that universities are hemorrhaging money every day right now. And so waiting for that day to come is very, very painful. Yeah. And of course, one of the one of the difficulties, the Supreme Court issued a stay recently in one of these cases where they said the problem is we have to keep the money from flowing out because we're being told that once the money flows out, it's not there for the government to seize back if the government ultimately wins, which seems almost to me to be getting things backwards. which is there's an irreparable injury to the researchers if the money is kept away from them, and therefore they have to close down the research or the like.