From COVID or with COVID?

Harlan Krumholz: Welcome to Health & Veritas. I’m Harlan Krumholz.

Howard Forman: And I’m Howie Forman. We are physicians and professors at Yale, and we’re trying to get closer to the truth about health and healthcare. Harlan, I wanted to start off with a bit of news that had escaped my attention during late December when Omicron hit, followed by the holidays. That is, the National Health Expenditure team in the Office of the Actuary released the annual tallies for health expenditures in the year 2020. And that might seem like really old data, but honestly—

Harlan Krumholz: Yeah, that seems so exciting, Howie. I just can’t imagine!

Howard Forman: I know! I know!

Harlan Krumholz: How did we miss that?

Howard Forman: I know! And the irony about this is, I really do get excited about this every year, because if it ever comes out—

Harlan Krumholz: That’s what makes you special, you know?

Howard Forman: It never comes out on exactly the same date. I’m always looking forward, and it’s something that I use in my teaching. So we now have these numbers, which are what people will use as soundbites for the next year when they talk about healthcare in the United States. Usually these numbers are roughly the same. They grow by a few percent every year, and there’s nothing surprising. But obviously with the pandemic, there’s this dramatic change. Can you believe that federal spending on healthcare alone grew by 36% in one year? Mostly due to the relief funds from the various COVID relief bills. Total spending grew by almost 10%. Our national healthcare spending is now over $4 trillion.

Harlan Krumholz: I know, but I don’t even know what these numbers mean. Look, when you say 36%, just to say, who received more money this year? I mean, because physician salaries didn’t go up 36%, and nurses’ salaries didn’t go up 36%. So who’s benefiting from that 36%?

Howard Forman: Yeah, I know. It’s a great point. So where did the money actually go? Well, hospital spending itself only went up by 6.4% in that year. Where did the biggest increases go? Nursing homes up by about 13%. Government spending on public health activities, as I mentioned, up 113% testing things to public health laboratories and so on. And as you point out, physician salaries did go up by only 5.4%, which is very much consistent with what those salaries have looked like over the last ten years.

Harlan Krumholz: I think one of the things I find that’s going to be hard, we tend to look at a larger arc of time to understand what’s going on in terms of trends in the healthcare system. This just throws a big wrench into the works. It’s hard to really even wrap your head around what these numbers mean.

Howard Forman: And it’s going to be even harder next year because one number I left out, dental spending? Down last year. Not surprisingly, the most discretionary things went down last year. Right now, as you know, we’re in a crunch in our hospital and other hospitals. There’s a lot of demand for health services right now. It’s hard for me to imagine that even when you remove all this federal spending, that we are going to be back to the old normal of 17 or 17 and a half percent of GDP spending on healthcare. We’re probably going to be closer to 18, 19% for the near future.

Harlan Krumholz: And you know, our hospital is projecting deficits and is concerned about how all this is going to look when everything shakes out. So we’re all watching with bated breath to see whether or not we’re going to return to a status quo that we’ve been on, or are we on a whole different curve as a result of what’s just happened?

Howard Forman: Right. So what has caught your attention this week, Krumholz?

Harlan Krumholz: Well, look, I wanted to talk about a couple of things regarding something you may not know about, which is that we’re in the midst of a pandemic.

Howard Forman: Oh, my God.

Harlan Krumholz: Yeah, I know. So here’s some fun facts. I’ll say “fun.” This is a very serious business, of course, the pandemic, but there’s some things that interested me that I picked up this week. On one hand, hospitalizations are up everywhere. But sometimes when I look at those figures, I ask myself, well, of course, the virus is everywhere right now so it doesn’t surprise me that a lot of people in the hospital have COVID, that is, are testing positive. But it’s going to be important to differentiate those hospitalized with COVID from those who are hospitalized for COVID. So let me ask you this, Howie. I mean, I’ll tell you what my estimate is, but what do you think is the proportion of people, of all those who are being attributed to having COVID, what percent of them are for COVID versus with COVID?

Howard Forman: So, this is a really interesting concern for me right now. In the UK, it went from about 25% of patients admitted to the hospital being with as opposed to for COVID up to about 33% over a matter of weeks as the Omicron wave came. And some of that is purely attributed to the fact that more pregnant women come in to deliver their babies and testing positive, clearly not from COVID. Same thing from motor vehicle trauma and so on. But what we are seeing in this, since I was going to ask you this today as well is, we’re seeing more and more people with vascular illnesses, whether it’s pulmonary embolism, heart attacks, or strokes, which we know are increased in the setting of COVID. We’re seeing more and more of those patients, and we’re saying that they’re here with COVID not from COVID, but we don’t know. Epidemiologically, we might be able to tease out numbers, but from an individual patient basis, it’s very hard to know. What do you think the numbers are?

Harlan Krumholz: Well, so that’s another interesting point you’re saying, which is that there may be people who are being hospitalized, not with or for, but with sequela, with complications that are downstream from the virus. So really, it is a result of the virus, but not of acute infection, but things that are happening as a result of having been infected or even concomitant with infection. I would say, it looks like, as I look around the nation in the U.S., that it’s about a third, which, I mean, is that there’s a third of people who were being hospitalized with COVID, but that wasn’t the primary reason.

So what we’re talking, just again to calibrate listeners, we’re saying of all the people admitted who were being labeled with COVID ... and by the way, we’ve done a study at Yale led by Rohan Khera and Wade Schulz that showed that a lot of this labeling is actually challenging. So we’re not even exact on the number of cases, because people are being mislabeled all the time. Just because the way that hospital codes, our data systems within this country, are just not strong enough to give us a real precision. But probably in large-scale numbers, the direction is correct and the bias, whatever it is, is consistent over time.

So when we look at rising levels of hospitalizations, whatever inaccuracies are in that measurement were in the inaccuracy six months ago, too. So it’s probably, at least you can compare over time. And of that rise, a third of people just have COVID, but that’s not the reason they were admitted. Two-thirds with COVID. That seems to be consistent in the ICU and on the wards and for vaxxed and unvaxxed.

By the way, when Howie, just to say, I was really amazed at this stat, when I heard it. At Yale New Haven [Hospital], among women delivering, I think this number was reported last week, half of the women were positive for COVID. So there’s one other important thing here, which is about the vax part. So we’re saying, who’s being admitted for or with COVID, but then how about if you’re vaxxed? Well, it turns out, like I said, the proportions are about the same. But as we know, in a state that 70% are vaxxed, about 70 to 80% of the people who are hospitalized are unvaxxed. So the risks to people who are unvaxxed are just many, many, many times higher. And so, people shouldn’t dismiss the possibility that getting infected with Omicron can cause complications. It can, sometimes severe, sometimes you even end up in the ICU, it’s just rare. But if you’re not vaxxed, it’s not rare. It can happen, and it has happened to a lot of people.

Howard Forman: I saw a patient this weekend that just summarizes this nicely. Came into the hospital, tested positive for COVID but was admitted for gastroenteritis, diarrhea, dehydration, things like that. Was in the hospital for like three days. Viral syndrome was sort of described as a possibility, but it was really about gastroenteritis. Comes back four weeks later, and now has COVID pneumonia. I think her original admission was actually not with COVID. It was actually from COVID. But now she clearly is a COVID pneumonia case. I think we’re seeing people that have longstanding sequela, if they’re unvaccinated, where it doesn’t necessarily hit you, and it’s gone in three days. For some people, it lingers, it leads to longer-lasting problems, and it takes time to leave.

Harlan Krumholz: We always talk a lot about the pandemic. It’s on our minds, but I got a couple other topics I want to run by you real quick. And then maybe you’ve got a couple too. So you may have seen the article that came out of from our colleagues Joe Ross and Reshma Ramachandran that was in JAMA Internal Medicine that looked at the amount of money that people have to pay out of pocket for premiums and how that’s changing over time. This is one of my favorite themes, which is this issue of underinsurance. People want to celebrate Obamacare. I want to celebrate it. I think it was a great step forward. But I think it’s only a part of the way to where we need to go, because it’s not enough to say we insured more people. By the way, there’s still many people without any insurance in this country, and I know you’re an expert on this.

And this underinsurance is a big deal. What they found was that between 2009 and 2019, that the annual inflation-adjusted out-of-pocket costs for guideline-recommended medications increased by 40% and was largely driven by the introduction of new brand name drugs that don’t face generic competition and whose prices are set by manufacturers. But this is a huge deal. I wonder, as an expert in health policy, how you think about this, because this is what’s causing financial toxicity for American families and also leading people not to take the medications that are prescribed to them.

Howard Forman: Look, it applies more broadly than just prescription drugs. The Commonwealth Fund had a monograph about two years ago made exactly the point you’re making, that we seemingly got about 20 million people off the rolls of the uninsured, but we increased the rolls of the underinsured by a similar amount. So we have more people underinsured in this country now than we’ve probably ever had. The definition of underinsured, I believe, is something like if you’re having to spend more than 20% out of your discretionary income, you’re underinsured. It’s an individual ranked by income. We have a lot of people that are underinsured in this country right now. That may not sound like a lot, but if you have a chronic illness, being underinsured means being financially devastated every time you have an exacerbation of your illness or even just to maintain the drugs that you have to take, you’re making decisions about putting food on the table or filling the prescription as it was ordered by a physician.

Harlan Krumholz: And I just want to make one more point about their piece, which is, these are people in Medicare. So, this is where there is no uninsured issue. These are all insured people, but the insurance is inadequate. I believe that this may begin a drumbeat of will within the public to say that this is just no longer acceptable. We can’t be thrown into financial crisis just because of our health and may push us to, I hope, to more creative solutions ultimately, making sure that there’s no one in the U.S. who suffers financial toxicity as a result of their healthcare.

Howard Forman: That has been one of the additional things being talked about in the so-called Build Back Better Bill by Biden is filling in this prescription drug cost sharing issue. It is large. Everybody knows it’s large. It might only affect a quarter of the overall population, but disproportionally, it hits Medicare beneficiaries. And we do need to do more for those that really don’t have the capacity to fill in these gaps.

Harlan Krumholz: Well, it drives me crazy because we have some lifesaving meds that really are out of reach for a lot of people, even though they have insurance coverage. So, the other thing I wanted to get your take on this week was what happened yesterday with Medicare and this new Alzheimer’s drug from Biogen. This is something which the estimates are to affect six million Americans. Honestly, it could be affecting many more people who are experiencing cognitive decline, and with an aging population, this is only becoming more important. In June 2021, the FDA approved their first Alzheimer’s drug in twenty years. And yet, this decision disregarded warnings from a lot of independent advisors that this treatment really didn’t have much to gain for people, didn’t add much benefit, and in fact, had risks that shouldn’t be sustained.

This thing is called Aduhelm. The generic name is aducanumab, and it’s what they call a monoclonal antibody. It’s an antibody. Your body produces antibodies against foreign invaders. This is an antibody that’s created that’s supposed to go after some of these clumps of protein that sometimes can accumulate in the brain and presumably signal to the body to start to clean it up. The idea was attractive. There was a lot of work that was done. Essentially, the monoclonal antibody tags on to that clump that’s causing problems and signals to the body that it should bring in the salvage crew and get rid of this. And yet, the studies were, I think, less than a resounding success. In fact, they had to go in and reanalyze the data design to show that there was some benefit.

A lot of us were surprised that the FDA approved it. There was a lot of concern when they originally priced this at over $50,000 a year. It’s in monthly injections in the doctor’s office. And like I said, potential side effects are the brain swelling and microhemorrhages in the brain. I mean, these are scary things. Then, it came to Medicare. Now, Medicare usually just automatically says, “Well, if FDA says it’s okay, we’re mandated.” I thought they were mandated, Howie, to sort of say, “We’re going to pay for things that FDA approved.” They’ve actually taken a turn here. So maybe I’m going to stop there and say, what is CMS’s [Centers for Medicare & Medicaid Services] responsibility to pay for something that the FDA says is approved?

Howard Forman: So CMS has done this before, if I recall, and almost in a very similar situation, and that was approving PET scanning for patients with Alzheimer’s back around 2002. They do have this discretion. It’s rarely exercised. They did almost the exact same thing, where they basically said, “We’ll approve it, but only if it’s being enrolled in a clinical trial and we follow data.” To this day, I don’t know that we’ve really seen great outcomes from that evaluative data that’s been obtained through Medicare reimbursement. So I don’t know what the absolute statute allows for, but I know this is not the first time it’s happened. But it is really frustrating that what basically is happening now is, Medicare is paying for the Phase 3 data collection that we should have already had in order to approve this drug. And as you’ve pointed out, the FDA did give approval, but not before its own advisory committee said thumbs down.

Harlan Krumholz: This is an interesting interplay between the two agencies because in the end, the FDA, again against advice of some experts, said, “We’re going to approve this.” They did say, “And we’d like a trial done.” They said, “We’d like a trial done.” But as everyone knows, that can take years. So they basically put this on the market. It got priced appropriately. Then, CMS is the one putting brakes on it. They’re not saying, “We’re not paying for it.” They’re saying, “We’re only going to pay for it if someone’s in a clinical trial.” The industry was squawking about this, but I thought, “Oh my gosh, this is CMS saying, ‘We’re essentially going to pay for a lot of your clinical trial because at the price you’re going to charge, which includes some margin, we’re going to pay for the drug.’” If they’re in a trial, I mean, if they’re smart, they don’t enroll a lot of people in a long-term trial.

I don’t know. I mean, I thought for industry, of course, they’d rather be selling it, but the truth is, no one was taking it up! I mean, a lot of hospitals were saying, “We’re not going to offer it. We don’t believe the data.” I’ve never seen quite like this before where an FDA decision is fought like that. And now CMS comes out and says, “We’re putting brakes on.” And the chief medical officer said, basically, “While there may be potential for promise with this treatment, there’s also the potential for serious harm to patients.” And basically, they’re opting not to provide their full support. It’s a really interesting turn of events.

Howard Forman: We talked about this with Joe Ross when we had him on a few weeks ago on the podcast. The original sin was that if you’re going to have an advisory committee, you have to show at least a little bit that you’re listening to them. This wasn’t an advisory committee that voted 7–6 to turn this down. This was an advisory committee that voted, if I’m not mistaken, unanimously to turn this down. The FDA went in the exact other direction and approved it. Then, after that, talked about how we need to review our processes better. But it’s very hard to imagine someone serving on an advisory committee if you know that someone’s not even going to listen to you when you are emphatic about your decisions.

Harlan Krumholz: But I will say that that advisory committee, because all those documents were public and the discussion was public and the vote was public, went a long way toward promoting the public dialogue about this. And as you know, a couple of our friends who were on the advisory committee quit the advisory committee after that. It sent an important signal to the group. By the way, our friend Joe Ross, who was on the program, was quoted in The Washington Post, and he applauds this decision by Medicare. So just to say, it was nice to see people looking to Joe for his opinion about that. How about you? I know you had a couple things on your mind this week.

Howard Forman: So really what’s been bugging me has been bugging me for months now, and as we’ve talked about even in the past, the surgeon general has raised the issue of misinformation particularly around COVID as being one of the greatest threats. I just see it continuing to perpetuate itself time and time again. One of those things was this interview that our CDC director, Dr. Rochelle Walensky, gave to Good Morning America on Friday. She talked about this nice paper. There’s nothing particularly special about it, but it’s just one more sort of observation of 1.2 million people who’ve been vaccinated over the course of a year to see what their COVID outcomes were. It showed that 0.0033% of 1.2 million—so, that’s 36 people—died of COVID despite being vaccinated. Now, that’s an extremely low number compared with what we would’ve expected. That’s not the point of the paper, but that is a really powerful thing. If you think about it, we’ve been losing about 0.1% of the population to COVID every nine months to a year. So 0.0033% is much, much lower than that.

But the point that was brought up in that interview was…and 28 of those 36 individuals had four or more comorbidities—four or more serious conditions in addition to being infected with COVID. The point she was making and the point I’ve made frequently to people is that the only bad outcomes I’m seeing among people who are vaccinated are in people who are elderly and not yet boosted or people who are immunocompromised. Her point was very similar because one of those comorbidities is being immunocompromised, meaning having cancer or being on some type of immunomodulation for a solid organ transplant and so on. If you go on social media, you will see an enormous number of people manipulating that information and distorting that information to make the claim that, “Oh, now the CDC is acknowledging that it’s only the very sick who die of COVID.” And that was not the point of this paper. The paper I think does add to the literature, and I think the CDC director was making a really important point. Vaccines work.

Harlan Krumholz: Well, here’s something that perplexes me. There are a couple articles this week, one in The New York Times, that was talking about social media and misinformation, YouTube, Facebook. But let’s take Facebook, for example. So Facebook says, “Yeah, it’s true that there’s a lot of misinformation on Facebook.” I mean, blatant misinformation. I don’t mean people who have different opinions, and I’m not talking about scientists who may hold opinions different than ours. I’m talking about, “The vaccination had a microchip in it,” or stuff like that. I mean, stuff that it’s not about debate even if we want to disagree with people or agree, but it’s about, really, stuff that’s just totally out of bounds. And Facebook says, “We’re doing our best.” I’m thinking, “Oh my God, you’ve got the most sophisticated algorithms of the world to target advertising. You’ve got natural language processing. You’ve got all of these tools, and somehow you’re perplexed by some of these gross, conspiracy theory, crazy stuff, that gets on the websites, and you can’t find a way to say, ‘That doesn’t have a home on Facebook, and we’re really going to do it.’”

I get it. It’s a whack-a-mole. I mean, there’s stuff that’s coming up all the time, but I mean, this is a company who, when you’re on a non-Facebook website, has got claws in you, and it knows what you’re looking at. I mean, they’ve got millions of ways that they’re tracking all of their users. I’ve just got to believe that they can put a little more oomph into this.

Howard Forman: Now, look, I agree, and Twitter in their terms of service says content that is demonstrably false or misleading and may lead to significant risk of harm such as increased exposure to the virus or adverse effects on public health systems may not be shared on Twitter. And it goes on to explain more about what they mean, but it is part of the terms of service. It is what we agree to when we agree to use Twitter or Facebook. I agree that it’s challenging. What you are talking about is like, we’re not talking about gray zone issues here. We’re talking about clear violations of the terms of service, where given the incredible technology available to Facebook, to Twitter, to YouTube, and so on, they should be capturing this really early on. It shouldn’t take four days and a hundred million people seeing not just misleading information but frank lies before they actually pull something down because the harm is already done. People believe it, and it becomes completely embedded in people’s consciousness.

Harlan Krumholz: Again, I acknowledge the challenge. I’m just urging them to think about ever improving what they’ve got in order to be able to accomplish this. But we’re seeing all sorts of crazy stuff. The final thing that I thought really bothered me was this person on Fox who talked about a kill shot to Tony Fauci. Also, the way that Fauci was being treated in the Senate. And again, we try to stay away from partisanship. We say that there are honorable people on all sides of the aisle, and there are people who do good work, but you take someone like Tony Fauci who for thirty-five years, I mean, he’s required to make annual disclosures. And then, while he’s up there, they’re saying, “Were you willing to disclose your conflicts of interest?” and he’s going, “Well, I’ve been doing that for thirty-five years.”

I mean, again, what’s my bias? I’ve met him. I’ve known his work. I’ve admired him for a long time. This is a tough job through these two administrations and a pandemic that was throwing us curveballs. Every time, here’s a guy who knows the science, has always approached us with a calm demeanor, and I think sound scientific advice. And he’s human. He’s trying to navigate this stuff as he goes, but I can’t imagine anyone doing a better job.

Howard Forman: 100%. And let’s remember that he was vilified by the left 35 years ago and 30 years ago for not doing enough for AIDS and HIV. So, he’s used to the attacks. But these attacks are not just on decision-making. These are attacks on him as a person. They are vile attacks, and the irony of the attack yesterday, for which Dr. Fauci was caught on a hot mic using the M-O-R-O-N word to describe a senator. The senator was a physician. The senator was an OB-GYN from Kansas. He knows better, and it was just beneath the dignity of both the individual and the office to be doing that to an honorable man.

Harlan Krumholz: It’s just hard. I mean, we want to attract the most talented people in the public service. And here’s a person who spent his career in public service. Alternative options, could have made more money, could have done lots of other different things; he served the country throughout many administrations and over many years in such a distinguished way. There needs to be a bit of respect for what someone has contributed to the country over their career. You can say that we have honest disagreements about this or that, but they can be done in a way that’s respectful.

I worry that the tenor of the country has put us in a position where we won’t have more Tony Faucis. We won’t have people who are willing to weather that kind of treatment publicly, let alone the personal threats. All these people are getting ... our friend Peter Otis talks about this. Getting death threats and so forth. I mean, we’ve got to clean this up in our country and be able to engage in respectful dialogue. Anyway, it’s just another point, a point of disappointment, but also one, I just wanted to shout out for Dr. Fauci for his service.

Howard Forman: Do you want to tell me what’s inspiring you or giving you hope these days?

Harlan Krumholz: I do perceive this Omicron thing as a mixed blessing. Of course, it’s causing a lot of harm, but I see it as a flash fire. If you’re vaccinated and protected, then it’s, the adverse effects are rare. It’s nature’s way of immunizing a large percent of the population, because people are getting it and developing antibodies. I’m hopeful that we get to mid-March, we’re going to be in a whole different situation. And I retain the hope that the future evolutionary change of this might be the continued increases in transmissibility and decreases in pathogenicity. By the way, that’s good for the virus. It’s good for us. If the virus wants to live, don’t kill us, don’t take us out, actually become asymptomatic, we’re happy to carry around, and I say that tongue in cheek, because if you want to see the adverse of that, I’m still concerned about this long COVID issue and who’s got persistent symptoms over time. I’m committed to the people who are suffering to try to get some of these answers working with Akiko Iwasaki. And we’re going to try to do some studies on this, so I don’t want to make light of this. But the fewer the people that get infected, the more the people have antibodies, the more that we can get past this, the better off we’re going to be.

Howard Forman: Yeah, I agree. I’m certainly as hopeful as you are, but as you’ve pointed out, I’m going to continue to remain very humble and say we don’t know what the future holds, and people should continue to be at least a little vigilant about what they’re going to plan for the future because it’s uncertain to all of us. This truly is novel.

Harlan Krumholz: You’ve been listening to Health & Veritas with Harlan Krumholz and Howie Forman.

Howard Forman: So how did we do? To give us your feedback or to keep the conversation going, you can find this on Twitter.

Harlan Krumholz: I’m @HMKYale. H-M-K-Y-A-L-E.

Howard Forman: And I’m @TheHowie. That’s @ T-H-E-H-O-W-I-E.

Harlan Krumholz: Health & Veritas is produced with the Yale School of Management. Thanks to our researcher Sherrie Wang and to our producer Miranda Shafer. Talk to you soon, Howie.

Howard Forman: Thanks very much, Harlan. Talk to you soon.