American Association for Physician Leadership

Quality and Risk

Mike Sacopulos interviews Dr. Michael Osterholm on SoundPractice

Michael J. Sacopulos, JD

February 10, 2021


Summary:

AAPL's SoundPractice Mike Sacopulos interviews Dr. Michael Osterholm, an epidemiologist and international medical detective, and director of the Center for Infectious Disease Research and Policy at the University of Minnesota.





AAPL's SoundPractice Mike Sacopulos interviews Dr. Michael Osterholm, an epidemiologist and international medical detective, and director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Mike Sacopulos (Host):My guest on today's AAPL SoundPractice is Dr. Michael Osterholm. He is an epidemiologist and international medical detective, and director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Welcome to SoundPractice!

Dr. Mike Osterholm:Thank you. I'm glad to be here with you.

Mike Sacopulos:Dr. Osterholm, you've been one of the most sought-after experts on COVID-19. And here at the AAPL, we've been following you since your 30-minute interview last May with policy fellows at the Center for Study of Politics and Government. You accurately predicted the trajectory of this novel virus. We are recording today in later January, 2021. From an epidemiological standpoint, can you predict what the next six months, 12 months, and two years will look like for our country?

Dr. Mike Osterholm:Well, first of all, again, thank you very much for having me. The earlier days of the pandemic in many ways were since more predictable, because at that point, we knew that virus, even in the first two months, in a much better way than we know the virus today. So I think that's an important qualification to add to our discussion. And also, we're at a very critical time in the potential for the number of cases to grow rapidly. And let me just give some perspective on that:

When you look back on the origins of the pandemic in those early days, remember when we got to 32,000 new cases a day in this country in April? The house was on fire. It couldn't get worse. New York City was in a disastrous position. Some cities like Chicago and New Orleans, Atlanta were getting hit hard, Southern California, some in Seattle. And we asked the public to help us bend this curve. And all the mitigation strategies, distancing, things went into place.

Well, by Memorial Day, we got cases down to 20,000 new cases a day, and when I say down, some might argue, (and I would be one of them) to say it wasn't nearly enough. Our European counterparts taught us you can do much better. But we became complacent. At that point, pandemic fatigue set in, and clearly, pandemic anger, that sense of people believing that the pandemic wasn't real, that it was some kind of a politically motivated activity.

Well, by July, when the Southern states from Southern California all the way across to Georgia lit up on fire, we saw case numbers rise precipitously. We got to 70,000 cases a day by mid-July, far, far exceeding that house on fire moment in April. And then, again, we urged that people limit their contacts with others, particularly in those states, the kind of trying to bend the curve again. And we actually got cases down to 26,000 new cases a day by Labor Day. Now, again, seen as a victory, but still a higher level than we were when we got them down in May.

And then it really started to take off. And at that point, I had said even in very early October on “Meet the Press,” I said, “The darkest days of the pandemic were ahead of us.” And people were surprised. If anything, they thought it was like crying fire in a crowded theater -- when it didn't exist. Well, as you know, by Thanksgiving, we were at 200,000 new cases a day, and that stayed there for a limited time. And then on December 1st, we saw it start to come down again, following really kind of the Thanksgiving hit in the upper Midwest, which had been the area on fire then. The case numbers started to drop precipitously.

So we got down to 160,000 cases, a kind of a new baseline. A lot higher than 20,000 or 26,000. Then the Southern states hit it again. From Southern California to Georgia, we saw it light up. On December 29th, we hit 200,000 cases a day again. On January 8th, we hit 300,000 cases a day. And now today, here we sit at about 185,000 cases a day and people think, "Wow, we've turned the corner," but we're at 185,000 cases a day, which, again, going back to either the July peak or the April peak is a much, much worse place to be.

We have 110,000 people hospitalized. This is what we call shifting baselines. This is where we have a whole new reality what's acceptable, what's not. And the reason why this is so important is in the past six to 10 weeks, we've seen this new curve ball thrown into the Coronavirus mix. And that is these variants, these highly mutated viruses that are changing, where we have more and more compelling evidence that at least one of the mutation changes or one of the variants, as we call them, is much, much more transmissible than were previous strains of the virus, as we're seeing right now in Europe, particularly in England, Ireland, Denmark, and so forth.

That virus is now here in the United States and it's spreading. And the challenge is what does that mean? Well, if you look at what happened in Europe, that virus circulated in each of those countries for six, 10 weeks before it took off, but then once it took off, it was like a forest fire.

Is that going to happen here? If it does, it is going to be on top of the base that we have, which already just put us almost close to going over what we could do in terms of healthcare provision here in this country. And I think that clearly, the darkest of the darkest days could potentially be out ahead of us. The next two to three months could make what has happened to date seem like it wasn't all that bad, just as now, wouldn't we welcome a day of only 32,000 cases a day when, in April, we couldn't believe how bad it was?

And that's the challenge we have right now. The variants. Then on top of it, there's another variant that has emerged in both Brazil and a separate one in South Africa, but with similar mutation changes, where it is actually rattling our cages. It may be that these variants will not respond to the antibody that's produced with the vaccine in a way that we would expect or want it to do, which means the vaccines could be compromised. This is a huge issue.

And so as I sit here today recording this with you, this is not a pretty picture. This is not good. The vaccines are coming. We can't get people vaccinated soon enough. I'm hoping that the vaccines will in fact protect us against all the strains coming down the pike and that we don't see this big peak associated with this particular variant from the United Kingdom, but both of those are sure possibilities. And that's a challenge.

Mike Sacopulos:It's with trepidation that I ask you to talk a little bit more about the variants. You've mentioned two I believe, on in the UK and then the other that's the Brazilian/South African.

Dr. Mike Osterholm:Yeah. Variants, first, are viruses that have undergone mutational changes so that they're different than they were before and that they actually survive in human-human transmission. So a lot of the coronaviruses, or what we call them, SARS-CoV2 viruses, actually go through mutations, but many of those mutations actually are disadvantages to the virus, not advantages, and they just don't circulate. They don't survive.

Now, if you take the one that I just mentioned in South Africa and in Brazil, which is very key, and this one is adapted to avoiding, it looks as if, the antibody produced by an individual who was previously infected with the virus, and very well, again, may also do that with the vaccine-related antibody.

So why did that occur? What happened? Well, remember a year ago right now, virtually no one in the world had been infected with this virus outside of a select area in China and just beginning to spread in other locations. There was virtually no one who was positive for antibody. No one had antibody. So there was no environmental or evolutionary advantage to being able to resist the antibody produced by someone because no one had it.

But as the world's population grew in numbers who did have this antibody from natural infection, or even from being treated with this plasma, this recovered antibody treatment, and now vaccination, there is a real advantage to being a virus that can evade the immune response to the host. And so that's forced those, and we call “escape mutants,” to exist, that now have an advantage in a population that has more antibody.

In terms of the variant that is more likely to transmit at a higher rate, again, that is one that has now obviously been fit to survive in humans. And because it does proliferate at this higher rate, it has an advantage in the sense of spreading itself.

And so these viruses that we call variants are ones with these mutations that continue to transmit in humans because there's some advantage to them in the human population that beats them out over the other viruses, the other variant types that occur. And that's what we're seeing right now.

Mike Sacopulos:As to the ineffectiveness of vaccines for one of the variants, is that thought to be true for all types of the different varieties of vaccines that we have across the board, or are some vaccines more or less effective as to that variant?

Dr. Mike Osterholm:Well, let me be really clear about this because I don't want any confusion out there and people saying, "Oh my, oh my, we're done." The studies that we have, to date, that support the potential for the virus to basically beat the antibody in our bodies have all largely been done looking at people who have had infection and have recovered and have had that immune response. That's the same kind of antibody you're seeing in the plasma treatment. Remember, those units are taken from people who've recovered and recovering the antibody from them, and then concentrated it and giving it back to patients.

These have not been conducted as such yet in any meaningful way with the actual antibody that develops after vaccination. And there's actually a reason to believe that the antibody after vaccination actually may be superior than after natural infection, just in terms of what it can do.So we still have to learn yet are the vaccine-induced antibodies as vulnerable to the potential for compromise by these variances as natural infection? And this is why, in part, the natural infection versus vaccine-induced antibody, we've continued to recommend people who have been previously infected still get vaccinated. We think we can actually improve on your immune response with the vaccines.

So we don't have any conclusive evidence yet that the vaccines themselves are compromised in any way. And I think that's important. It doesn't mean it's not going to happen. It doesn't mean we're not going to see it. And it surely doesn't mean that we're not going to have a whole lot of new variants arising over the course of the next months to years.

And so everything's on the table right now. One, are we going to have more transmission? Two, are the variants going to be able to evade either clinical disease-related immune protection or vaccine-related immune protection? We don't know. But this is the kind of curve ball that when you throw that into the mix, it causes great, great concern.

Mike Sacopulos:Absolutely. Thanks for that clarification. So you are now part of president Biden's COVID-19 advisory board. Can you tell us what you will be doing as part of that panel?

Dr. Mike Osterholm:Well, actually, I hate to break the news, but that advisory board was put into place immediately after the election and only ran until the inauguration, meaning that it's not a federal advisory group yet. That has to go through various specific requirements in terms of qualification and conflicts of interest and so forth. Our goal was to really help the President-Elect and the Vice President-Elect's transition teams develop the kind of documents you saw provided to the public on that first day, the plan, the idea of what to do next, how are we going to respond to the need for additional vaccines? So that was our effort.

Now, I can say that many of us on the advisory board are continuing to advise the government in a more informal capacity. These are the same people, by the way, who were on the transition team that we're now advising as official government officials, but not in any federal official capacity are we doing that.

Mike Sacopulos:Could you give us some background on the status of vaccine development and distribution in our country?

Dr. Mike Osterholm:Well, about six weeks ago on one of my podcasts that I do on a weekly basis, I actually entitled one of them called, “The Last Mile, The Last Inch.” Long before we actually had the challenge with getting vaccines out, I saw this disaster beginning to unfold.

What Operation Warp Speed did to bring us these new vaccines was simply remarkable, a Manhattan Project-like effort. We took vaccines from basic research and development to field trials, to evaluation, to safety evaluation, as well as how well the vaccines worked, to approval process through the FDA and manufacturing all at the same time, remarkable, but they basically didn't understand that last mile. And Operation Warp Speed didn't plan for that.

And what I mean by that last mile, I'm talking about the bridge that is 437 feet long. And the problem was there were 10 feet that they didn't have money for to finish on the other side. Not a very effective bridge. Remember, a vaccine is just a vaccine. It doesn't become anything until it's the vaccination.

And so what happened was Operation Warp Speed just said, "We're going to just put these vaccines in your state and we'll dump them down. They're all yours." And there were no plans made nor federal support for state health departments to build the teams that would oversee this. And remember, while there are many different parties who will be involved with vaccinations, in the end, the state and local health departments are the air traffic control in our communities. So if we're going to use the private sector, we're going to use healthcare facilities, we're going to use community clinics, we're going to use the National Guard, we're going to use volunteers, we're going to use pharmacies, somebody has to coordinate all that. Somebody has to make sure that the community is covered completely, and you don't have some four organizations trying to vaccinate the same person and nobody trying to vaccinate these 10 over here.

Well, state and local health departments right now have been stretched to the nth degree. Want to know why it's one of the safest years in this country for foodborne disease? Because nobody was there to hear it when that foodborne disease went down. They were all working on COVID and there are no extra resources available. So the lack of timely support for states meant that this vaccine was getting dumped into areas where there hadn't been adequate preparation.

The second part of it was a large chunk of the vaccine initially was allocated for longterm care facilities, which is vaccine that was immediately, in a sense, deposited in your state, but it was for long for doing the longterm care follow-up, which was done by two private companies which had a contract with the federal government which the state had no accountability for at all. And they were incredibly slow to get off the mark.And so the delay meant that the vaccine sat there and the longterm care facility didn't get vaccinated it right away. And then of course, then healthcare facilities, hospitals, medical centers were then responsible for that other amount of vaccine that was put out there, again, under their control.

But the key to all of this is understanding what do we mean by distribution and vaccination? And it turns out that the media and most political leaders didn't understand that these numbers don't mean much. And what I mean by that is, is that Operation Warp Speed on a Tuesday will tell the state, "Okay, you have this many doses for next week. This is what you get." And they would then give the state 24 to 48 hours to put in their order, which all states went for everything, and then the vaccine was shipped out. It might take several days before the vaccine would arrive in the state, yet those numbers were posted the moment the vaccine had been ordered. So you could have four or five days or more where you now have a big number on your distribution list, but in fact, you don't even have the vaccine there. And so those numbers were erroneous and still remain so as such.

On the other side of the house is the fact that the electronic surveillance systems we have to detect when people get vaccinated and follow them are really disjointed. There was no clear and compelling way to bring all this data together. There was one federal effort. Tiberius is a system that is doing the majority of the work, but there's still real challenges. It often takes two days or more before people who are vaccinated actually get counted.

So between the distribution numbers being inflated over here as to what's actually in my state, as to being behind and counting the number of vaccines on this side, you can see this very large disparity in those two, which actually didn't really exist. So I think that's becoming increasingly clear right now that if you look, the numbers are getting tighter and tighter between distribution and amount out there as things are getting fixed.

The final point I would just make in all of this is it still means that we have a lot of work to do going forward. We estimate right now that there'll probably be about 12 to 18 million doses of vaccine produced each week in this country and distributed. That, remember, is based on a two dose regimen, meaning that somewhere between six to nine million people a week can be vaccinated in the sense of having that second dose. You can do the math on that and understand how long it's going to take to vaccinate the country without additional manufacturing capacity for these vaccines, which is hoped for, but it's not going to happen soon, or we get new vaccines that are approved and brought into the mix.

So I think the message we have to get across to the public right now is that everything's being done that can be done to get vaccine manufactured and out. The state and local health departments have become, really, the key shock absorber in our communities because people are angry, and rightfully so. If I sat on a phone for four hours waiting for an appointment to get my vaccine, and at the end, I couldn't get in, or I was on a computer program for all afternoon and couldn't get in, or even so, and we've had this happen where people do have an appointment in a scheduled clinic, only to find out a day and a half before that scheduled clinic, "Oh, well, the vaccine isn't coming this week. We didn't get as much as we thought, you're not getting your vaccine."

So people are very, very frustrated. And on top of it, in the... And I'm not sure why this was done. I commented on it in “The Washington Post” the day it happened, and in somewhat stern terms, was we then had the former Secretary of Health and Human Services, Alex Azar, who said, "We're not only going to go to open it up to everybody over 65 years of age come in, but we're going to open it up to everyone 21 years of age to 65 years of age who has underlying health problems," which is 81 million people. We don't have that vaccine at all for them. So when I heard that I was incredibly frustrated as a citizen, saying, "Wait a minute, you said I could get it and now you're telling me I can't because you don't have it."

So I think that we have to do a much, much better job of not only trying to get as much vaccine as we can as quickly as we can, but how those numbers are translated to state and local health agencies so that they can, with all the transparency, tell the state exactly, "This is how many doses we got. This is how it's being used. And if you're not in line yet, we're sorry. We're trying to get to you as quickly as we possibly can."

And then at the same time, the federal government, together with the manufacturers, just have to do a much better job of accurately detailing when that vaccine is coming and how much. We don't want to schedule large clinics and then have to cancel them two days beforehand. And I think that's the challenge we have right now. It's not about distributing the vaccine, it's not having vaccine to distribute.

Mike Sacopulos:But there are other issues. I think you would agree we make a mistake in thinking that physicians who are certainly highly trained in science will trust science and take the vaccine, but we've seen evidence that some physicians and some nurses are planning to wait for published safety profiles before they get vaccinated. How do you suggest we deal with these folks have little faith. Do you have any up-to-date numbers on just how many or how widespread this issue is?

Dr. Mike Osterholm:Well, let me just refer back to a comment I made a moment ago when I talked about that podcast I did. I called it, “The Last Mile and The Last Inch.” The last mile was getting the vaccine into our communities, the last inch was getting the needle into the arm. And we really have done a very, very poor job of explaining what these vaccines are, how they got made, and why you as an individual should want to get this vaccine.

When you look at the sense of Operation Warp Speed, what a terrible name. When you then add to it a military touch, you think, "Oh my, this had to be something sped through quickly that I didn't basically have any understanding of how safe this is." And that's fair. We've not told the story of Operation Warp Speed, that there were no safety steps that were cut short or that were left out.

Number two is Messenger RNA vaccines. We have seen repeatedly a misunderstanding about what these vaccines are and how much disinformation is out there about somehow, they're going to impact your genes and that getting this vaccine is potentially dangerous. We've had over 20 years of research with mRNA vaccines, and we can say that this is just a platform. And the analogy I use, for the few people on this webcast who are old enough to remember that old phone that sat on your wall where you had to take and turn the dial to get a number to be registered, if you listen to the voice on there, it was the voice. Now, come forward to the modern mobile phone of today that is a gadget that can do many, many different things, but guess what? Your mom's voice is still the same on that one as it was back in the old crank phone. No different.

These vaccines we have, these mRNA vaccines are just a way to deliver the antigen, the thing that we want the body to obviously mount the immune response to. And they are not some challenge to our genetics or what we do. We've not told that story. And I mean, I've heard this from nurses and doctors who are concerned about what this may do to their own cells and the genetics of their cells.

So the first thing we really have to do with this new effort now that's coming forward with the Administration is, one, we have to understand the knowledge, attitudes and beliefs of people who are going to receive the vaccine, which should be all of us, and that includes doctors and nurses. We have clear and compelling information that shows, in some locations, up to 30 to 40% of doctors and/or nurses won't take the vaccine. We have data that show that in some locations, in fact, many more than we care to acknowledge, in the Black community, young Black men won't touch this vaccine out of concern for safety.

And so we have a lot of work to do to get that last inch done. The more people we vaccinate, the better the chances we can control this virus in our communities. And so we surely want to protect everyone, and I want to be protected when it's my turn to get the vaccine, but I also know that vaccinating the community in of itself is a measure of protection above and beyond any one person getting vaccinated because that's what will slow down the transmission of the virus in our communities.

So we have a lot of work to do, a lot of work to do. And it's telling the story of Operation Warp Speed, telling the story of mRNA vaccines, telling the story of how dangerous COVID-19 is, telling the story of why that vaccine may save your life or the life of a loved one. And I think we surely need to start that yesterday and we can't do it fast enough.

Mike Sacopulos:Our physician members of the AAPL, especially those who work in medical school administration, have discussed “The Fauci Effect,” which is an increased interest in medical school and healthcare careers inspired by frontline health workers. Are you aware of that type of effect in public health virology or the world of epidemiology?

Dr. Mike Osterholm:I am. We've had a major increase in applications in all of those areas. So I think the effect of the pandemic has surely expanded the imagination and the interest of our younger population who wants to go into public health.

Mike Sacopulos:Our guest has been Professor Michael Osterholm of the University of Minnesota. Thank you so much for your time.

Dr. Mike Osterholm:Thank you very much for having me.

Listen to this podcast on SoundPractice . January 28, 2021

Michael T. Osterholm, PhD, MPH is an epidemiologist and Director of the Center for Infectious Disease Research and Policy (CIDRAP) at The University of Minnesota.

https://www.cidrap.umn.edu/covid-19/podcasts-webinars https://www.cidrap.umn.edu/about-us/cidrap-staff/michael-t-osterholm-phd-mph


Michael J. Sacopulos, JD

Founder and President, Medical Risk Institute; General Counsel for Medical Justice Services; and host of “SoundPractice,” a podcast that delivers practical information and fresh perspectives for physician leaders and those running healthcare systems; Terre Haute, Indiana; email: msacopulos@physicianleaders.org ; website: www.medriskinstitute.com

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