#59 Why COVID Crushed Us & How To Defeat Future Pandemics: Former FDA Commissioner Scott Gottlieb

What this episode is about

Former FDA Commissioner Scott Gottlieb discusses the systemic failures in the U.S. government's pandemic preparedness that contributed to the COVID-19 crisis, emphasizing the focus on influenza over other pathogens like coronaviruses. He outlines lessons learned and strategies for better handling future health emergencies, including potential threats from emerging viruses or bioengineered agents.

Key takeaways

• The US wasn't ready for COVID; pandemic planning was stuck in a flu-focused time warp.
• Operation Warp Speed: A billion-dollar bet that proved speed can be a game's secret weapon.
• RNA viruses are the real threat—learned the hard way when we took coronaviruses off our radar.
• From 4 years to a few months: COVID vaccines broke records by shattering the status quo.
• We need broader pandemic preparedness; a one-size-fits-all approach leaves too many viral shoes to fill.

Who speaks in this episode?

• Lynn Tommen (Host) · 7 min speaking
• Scott Gottlieb (Guest) · 17 min speaking

What is discussed, and when

1. 0:00 – 5:00: Uncontrolled Spread, FDA
2. 5:00 – 10:00: Department of Defense
3. 10:00 – 15:00: CDC
4. 20:00 – 24:44: Uncontrolled Spread

Notable quotes from "#59 Why COVID Crushed Us & How To Defeat Future Pandemics: Former FDA Commissioner Scott Gottlieb"

• Today I'm excited to be with Dr Scott SC Le he's a former commissioner of the FDA and the author of uncontrolled spread why covid-19 crushed Us and how we can defeat the next…

  about Uncontrolled Spread · at 0:27

• Manufacturing and distribution of a product if we were going to launch a mass vaccination campaign and that was the DOD so operation warp speed was a marriage really between…

  about Department of Defense · at 4:55

• The virus was but tell us where it wasn't so that we could Target our mitigation more effectively CDC failed to roll out the diagnostic on time everyone knows that part of the…

  about CDC · at 10:06

Who and what is mentioned in this episode?

People

• Lynn Toman — Person · Host · 2 mentions
  Hosts the episode, frames the discussion around systemic U.S. pandemic failures and future preparedness, and prompts detailed explanations on testing, data, CDC, and Operation Warp Speed.
  Hi everyone, it's Lynn Toman welcome to another episode...

Books & papers

• Uncontrolled Spread — Book · Primary recommendation · 2 mentions · first at 0:32
  The book authored by the guest, discussing the COVID-19 pandemic response.

Companies & orgs

• CDC — Company · Key organization · 1 mention · first at 10:08
  Discussed for its role and failures in the pandemic response, particularly in testing.
• FDA — Company · Key organization · 1 mention · first at 0:27
  Mentioned in the context of its role in vaccine approval and pandemic response.
  And Columbia Lynn tomen hi everyone it's Lyn tomman welcome to another episode today I'm excited to be with Dr Scott SC Le he's a former commissioner of the FDA and the author…
• Astra Zeneca — Company · Business focus · 2 mentions
  Another company that developed a traditional vaccine for COVID-19.
• Department of Defense — Company · Key organization · 1 mention · first at 5:04
  Played a role in Operation Warp Speed for vaccine distribution.

Full transcript with timestamps

0:01 welcome to the three takeaways podcast which features short memorable conversations with the world's best thinkers Business Leaders writers politicians scientists and other newsmakers each episode ends with the three key takeaways that person has learned over their lives and their careers and now your host and board member of schools at Harvard Princeton and Columbia Lynn tomen hi everyone it's Lyn tomman welcome to another episode today I'm excited to be with Dr Scott SC Le he's a former commissioner of the FDA and the author of uncontrolled spread why covid-19 crushed Us and how we can defeat the next pandemic it is a great read I highly recommend it Scott was in regular contact throughout the pandemic with all the key players in the government and the drug and diagnostic companies I'm looking forward to getting an inside account of how essentially a systemwide failure across the US government left the country blind and

0:59 also I'm looking forward to finding out how we can prepare for the next Health crisis whether it's a deadlier Corona virus variant a flu pandemic or even a man-made biological threat welcome Scott and thanks so much for our conversation today thanks for having me Scott the US put together its first health emergency preparedness plan decades ago under the second President Bush why wasn't the US better prepared for Co well first of all a lot of our planning was for influenza when we thought about pandemic preparedness in the past we always took a pathogen by pathogen approach to it and we tried to anticipate what the pathogens were that were going to threaten us and invariably we always focused on influenza as a naturally occurring risk and then we also focused on what we referred to as special pathogens things that could be used by wouldbe terrorists like Anthrax or small poox we never anticipated Corona viruses

1:55 certainly but we also never anticipated something that would occur naturally but spread very differently than influenza and so the capacities that we had built were really very flu focused we built what we call the influenza like illness surveillance system where we collected information inside hospitals to try to serve as an early trip wire to when a novel strain of influenza might be spreading and we thought that that would also be sufficient for alerting us to the spread of any kind of Novel respiratory pathogen including coronavirus we thought that that would be applicable here and we stockpiled drugs like Tamiflu and other Therapeutics that would be operable in the setting of a pandemic flu never anticipating that the pandemic that would ultimately threaten us would be a novel coron virus what we really should have been doing was building broad capacities to try to thwart entire categories of diseases that had pandemic

2:42 potential and really the category of diseases that we needed to be worried about were diseases that replicated through RNA and spread through aerosols or respiratory droplets viruses that spread through droplets or aerosols have the capacity to spread very quickly so those are the characteristics that create pandemic potential if you're looking at threats through that prism the universe of viruses that could potentially threaten us is much broader than just influenza interesting operation warp speed the Trump administration's program of creating a portfolio approach to vaccines of funding several different companies for each different type of vaccine was really Innovative the US government provided over a billion dollars each to madna for its mRNA vaccine and to Johnson and Johnson and astrazenica for their more traditional vaccine and these three companies created three of the world's most successful vaccines

3:35 before operation warp speed the shortest time to develop a new vaccine I think was about four years but these three companies all develop vaccines in a few months as did fizer the US government also provided funding as part of operation warp speed to companies to develop covid treatments regeneron one of the companies funded by the government developed an antibody treatment which was one of the most successful covid treat treat ments what do you think about operation warp speed and its portfolio approach and do you think the US should take a similar portfolio funding approach for developing vaccines and treatments for other major diseases well I think operation warp spe is really recognition that we didn't have a capacity in place that could both marry the scientific capabilities that we needed with the sort of operational and logistical capability that was required to do something on this kind of a scale to

4:29 respond to a crisis of this magnitude and we really lacked that early on in the crisis and there was a recognition that if we wanted to be able to get a vaccine more quickly than what was traditional we needed to get the regulators and the scientific agencies that would be involved in helping to develop that product NIH FDA married to some kind of operational capability someone with an operational mindset that could make the Investments that were needed to do the rapid scaleup of manufacturing and distribution of a product if we were going to launch a mass vaccination campaign and that was the DOD so operation warp speed was a marriage really between NIH and FDA and the Department of Defense to try to get this done more quickly we were really at a technological inflection point and that's what in my view enabled us to come up with these vaccine constructs so quickly and that inflection point was

5:15 that we were right at the cusp of an age where we went from sort of a wet approach to developing vaccines where the traditional approach was you you find a virus that you want to develop a vaccine against you grow it in cell cultures you inactivate the virus you cleave off its surface proteins to use those proteins in the syringe effectively as the vaccine that's how we make flu vaccine each season and we move towards an age where we were able to synthetically derive these vaccine constructs using the sequence information alone in the case of the vaccines by madna and fiser which I'm on the board of the sequence was used to basically manufacture a strand of mRNA and mRNA is a nucleic acid it's like our DNA but it codes for the production of proteins and in this Case by giving an mRNA sequence that coded for the production of a protein found on the surface of the Corona virus the spike protein you're able to basically use our

6:09 bodies as a manufacturing plant for the spike protein to generate enough Spike protein for our immune systems to recognize and develop immunity against so it really was the ability to use this fully synthetic technology that allowed us to Pivot very quickly if this was three or four years ago we wouldn't have been able to do this if this was 3 or 4 years from now this probably would have been mainstream the why fiser was able to Pivot as quickly as it did was because they actually had a program where they were trying to develop a flu vaccine using this technology so they were already starting to use this technology the final point I'll make though just as sort of an aside is there was nothing fast about the development process once we had the vaccine construct these vaccines were put in some of the largest and perhaps the largest clinical trials ever undertaken against a single virus people were

6:55 motivated to get into the trials and they unfortunately read out quickly because had a lot of covid so there were a lot of people in the placebo arms of these trials getting infected and getting sick so you reached the end point quickly the end point was a certain number of people having symptomatic disease and unfortunately there was so much infection around the country that endpoint was reached much more quickly than what we anticipated Scott what will that new technology enable for the future we're going to see other vaccines developed using the MRNA technology madna recently had an R&D day fiser has talked publicly about their portfolio as well and other companies are in this space Also these aren't the only two companies working on mRNA technology for vaccines I think you're going to see a host of different vaccines that are going to be developed for different diseases using this platform the observation with the MRNA

7:45 technology is that the immune response that was generated in the clinical trials show a very consistent response across age groups typically what you'll see is young people will derive a robust response to a vaccine but it's harder to get older individuals to derive the same robust immune response but when you look at the clinical data from the co trials you see a very consistent response across all age groups and that may be something unique to the MRNA platform and that makes it particularly attractive the technology is also being used to develop Therapeutics one of the places that's been put into development is developing cancer Therapeutics to try to use mRNA and the proteins to elicit an imuno response to epitopes found on cancer cells is a way to develop basically an immunotherapy that could potentially Target different kinds of cancers also has the potential to be used in certain rare disease settings

8:32 but I think you're going to see it become a more common technology backbone for a broader array of Therapeutics interesting the US was extraordinarily successful at developing covid vaccines on the other hand many other countries were much more successful at managing the public health side of Co that is everything except the vaccines can you tell us what the US failed at and why you think that the US failed well well I think there were different failures at different time points along this crisis but I think at the outset other countries were able to use testing and tracing and quarantine to try to control the introduction of the infection and blunt the peaks of their early epidemics this was going to become a global pandemic every nation was going to be impacted by this I don't think getting to quote zero covid here in the US and having an experience like what Australia is having or New Zealand where they're

9:26 willing to implement really sustained shutdowns in order to keep the infection out entirely in China as well I don't think that that was sustainable here our early shutdowns were to try to preserve the capacity of the Health Care system and blunt the impact of that first wave of infection until we could get to some effective Therapeutics and have better capacities in place to deal with this it wasn't to keep the virus out of the country we were never going to be able to do that but we could have mitigated the impact that Co had on us and early on I think the key missing ingredient was the lack of a diagnostic test that could be used to diagnose patients and do effective tracking and tracing of the virus and also not only tell us where the virus was but tell us where it wasn't so that we could Target our mitigation more effectively CDC failed to roll out the diagnostic on time everyone knows that part of the story

10:15 but even if CDC had been successful we still wouldn't have had enough diagnostic testing we had taken an approach where we had a very sequential process where CDC was going to design this diagnostic make it available the Public Health Labs they were going to start doing testing that highly sequential process was going to take far too long to unfold in the setting of a fast moving pandemic and was never going to provide the kind of capacity that we needed up front we needed a completely different mindset we needed a novel test we needed to get it out on novel Platforms in many cases we needed to build the capacity to collect respiratory swabs and in order to get that we couldn't rely on CDC to roll that out we needed to turn very quickly to commercial manufacturers sometime in January someone needed to call up the large commercial manufacturers who made diagnostic test kits and said we need

11:00 your help but that call was never made and the commercial manufacturers were never spun up we were overly dependent upon the CDC process and so that prevented us from being able to use testing and tracing of infection and getting people into quarantine as a way to control the early spread but what it also did is it prevented us from knowing where the virus wasn't and so in the beginning back in March we shut down New York San Francisco Boston New Orleans we knew that those cities had epidemic spread but the virus wasn't really spreading at any appreciable level in Austin or Jacksonville or in Wyoming so there were parts of the country that didn't need to shut down you could have still used testing and tracing and quarantine as a way to control the spread and then you would have preserved the political Capital to implement the population wide mitigation later on when the virus eventually became epidemic in

11:49 those parts of the country as it did later in the summer but as it turned out when it eventually became epidemic in Arizona and Florida and Texas and other parts of the Deep South people down there said look we've already shut down you told us to shut down the spring we did we didn't have to we're not shutting down again and so you lost the political Capital that you needed to implement the mitigation later when the virus eventually became epidemic because you did it too early and so the lack of the diagnostic test was the route of a lot of our subsequent problems that's why South Korea did so well because they turned to their private industry immediately and started mass producing diagnostic tests and scaled a level of testing that we would never achieve in the first six months of the crisis your example of South Korea I found extraordinary that within one week they had approved tests they had

12:35 drive-through testing the US still does not have massive Community testing why is that well I think right now we're in a much better place with respect to testing but the nature of the testing has shifted more of the testing is point of care more of the testing is moving into the home so you're seeing community- based testing sites these Mass testing sites be uced you don't want a platform where people have to go to these Mass testing sites in order to get a diagnostic test you want it to be much more accessible to Consumers so right now I think we have enough testing to keep up with the pandemic it's just that we're not really measuring a lot of the testing it's getting done because more of it's not getting reported a lot of the negative results are getting lost so it's actually overstating probably the positivity because we're not capturing a lot of negative tests that are happening why isn't there testing

13:27 though every time for for example someone enters a building or enters a subway system just massive Community testing in order to track and identify where cases are and how people are getting infected yeah I think we could be doing much more Community Based testing than we are and the best example of that is the schools if you look at the literature on what can be done to prevent outbreaks of covid in schools the two most impactful measures that people can take are to keep students in geograph Ally contained social pods and also implementing routine testing in school ideally twice a week at least once a week there is plenty of resources available to do testing in schools yet you're still seeing most schools not Implement routine testing as a way to identify cases and prevent outbreaks in the school setting and also testing to keep students in the classroom so the question is why aren't schools doing it

14:22 and the only answer I can arrive at is they don't want to deal with the complexity of turning over the positive cases that if you end up putting a testing protocol in place you're going to identify asymptomatic infection parents are going to get upset so the complexity of the politics around testing is what's I think causing a lot of schools to be reluctant to do it and I think the same thing is transferable to the workplaces as this become something a little bit more akin to the flu where it's an expectation of life that we are going to be at risk of this Corona virus and perpetuity I think the idea of turning over cases in a workplace setting will lose some of the stigma Maybe see more businesses start to implement routine testing the problem with doing it in something like a Subway or public venue is just the queueing up it's hard often to operationalize that but in an office setting or a school

15:12 those operational challenges go away and I think it's more the policy challenges the data and analytics in the United States seem to be lacking in many cases the US does not do much genomic sequencing and there seems to be little if any data on hospitalized patients in terms of which vaccine they got the length of time since vaccination their age their comorbidities why is the US seem to have such little data and analytics around Co yeah we do a poor job of systematically collecting the kind of public health information that you need in a setting of a crisis and I think this is another challenge associated with CDC CDC is not in the business of producing real-time actionable information and that informs current decision-making CDC is a agency it's a high science organization with a very retrospective mindset they do very Exquisite analyses of outbreaks that have occurred and are in the business of

16:12 providing the definitive answer they're not in the business of providing a partial answer in a real-time basis we don't have an agency like that in the case of breakthrough infections the data that the CDC has been relying on are the so-called cohort studies where they have prospectively followed certain cohorts of people these are groups of tens of thousands of people not hundreds of thousands of people so there's a cohort of nursing home patients there's a cohort of essential workers there's a cohort of healthcare workers they followed groups who are perceived to be at high risk of getting covid or having a bad covid outcome to see what their experience is over time so it's very likely that there's a higher rate of Prior covid infection among these groups even before they got vaccinated so this isn't a representative sample of the US population this shouldn't be the data set that we're using to drive

16:56 conclusions about the risk of breakthrough infections yet that's what we're forced to rely on because that's what the CDC is collecting we need a capacity to collect and disseminate much more realtime information because the reality is policy makers are forced to make decisions in the moment they need as much information as possible to inform those decisions and it seems like the other issue is that nobody reports to the CDC or the FDA or the federal government it's not as if any kind of state or city Health officers report up on a federal level what would effective leadership from the US government need to look like for a pandemic that's right the states aren't forced to report information there's Arrangements that the CDC has with state public health authorities for Gathering certain information but a lot of this information you shouldn't have to be dependent upon states to report it CDC

17:51 should have had the ability to consolidate existing Healthcare information to try to answer some of the questions like how many people are being hospitalized every day for Co but instead they relied on states to report these bespoke feeds separately from what states normally report to other kinds of databases and so they became dependent on Estates well this became a problem when the drug REM dese became available and suddenly you had a therapeutic that was in short supply that the government wanted to make available to hospitals that had hospitalized covid patients and what the people in the White House said Deborah Burke said is we can't ship a scarce drug to hypothetical patients derived off model we need to know how many patients are in each hospital and that's when they took away the function from CDC they basically said we can't rely on your data anymore we're going to create a new system and we're actually

18:39 going to get hospitals to report the number of hospitalizations they have every day and the system got started it had some Kinks early on but it ended up being the most reliable data set in the whole crisis the people who did the co tracking project at the Atlantic which was a great aggregation of data that was used by public health officials all across the world to gauge the epidemic in the US when they concluded that project they basically said that the data set that they came to rely on most was the hospital reporting data it was the most reliable data the CDC just didn't do it and it didn't want to move away from the system that they had and so this is where the system needs to change just a whole orientation to how we collect and deemed information needs to be handled differently so if you were asked to design our health system to prepare for the next pandemic from A to Z what changes and what capabilities do you

19:28 think think that we need it's a really big question I'll touch on some of them I think first of all Co exposed how excessively vulnerable certain communities in our society are to disease and to healthcare crisis of any magnitude but certainly of this magnitude we saw that covid hurt much worse certain communities than it hurt others people from lower incomes who lived in crowded housing situations who had multigenerational families where if one person brought the virus home the whole household was exposed to the virus older individuals who were excessively vulnerable people who faced racial bias in the delivery of healthare and so we're going to need to address that I think Co has galvanized some level of public support and public recognition in a way that hopefully we will be addressing these issues going forward the other thing we lacked is just the capacity to scale a response we didn't have the resiliency

20:18 we needed in the healthc care system we didn't have the ability to mass produce diagnostic test we didn't think about building those capacities and creating that resiliency as a matter of our national security that needs to change as well it seems like there need to be changes in leadership that the CDC is not ideal to lead in a real life pandemic it seems like there also need to be changes in infrastructure hospital beds you talked about equipment maybe manufactured domestically some of the biologics and Other Drugs I think we had enough Hospital capacity or we have a lot of Hospital capacity it was clearly the Health Care system at points became a Health Care system and we could think differently about how we maintain certain residual capacities or require hospitals to maintain the capacity to Surge their health care I think it's a question of having the planning in place to be able to quickly use the existing

21:15 infrastructure in a surge capacity New York did that very effectively what New York achieved I think is going to be studied very closely the fact that they were able to effectively turn their healthare system into a healthare system and deliver crisis levels of Care at the proportion that they did is phenomenal how about global monitoring and cooperation it seems like the world is not doing a very good job of that what could we do differently or better to prepare for the next Global Health crisis well I think we've relied for far too long on International conventions and the idea of building capacities in foreign Nations that may be hot spots for emerging infections and just sort of coming together as a global Community holding hands and promising that we're going to share information in time of Crisis and if you're a country that's host to an emerging infection you're going to tell everyone and you're going

22:06 to share the strains of the virus so everyone can get a head start in developing Therapeutics and vaccines that doesn't work we've seen time and again and we saw in this case that when other countries are host to emerging affections they oftentimes don't share that information in a very timely way so I think we're going to have to lean much more heavily on our foreign intelligence services to gather this information and make Public Health an explicit part of our national security preparedness and an explicit part of what the mission is of our foreign intelligence agencies if anything the behaviors in SARS CO2 condition Nations to be even less forthcoming and that's going to make us even more dependent upon our foreign intelligence services so interesting I would not have thought that Health would be a new area for intelligence Services Scott what are the three takeaways you'd like to leave the audience with well I

22:54 think we touched on a lot of them the idea that we need to build better resiliency in to our Public Health System we can't just operate for maximal efficiency in terms of how we manufacture products but also operate for some level of resiliency the fact that we're going to need to look at Public Health preparedness through a lens of National Security and get our foreign intelligence agencies more engaged in this Public Health Mission and then just the idea that CDC is a great organization a high science organization does exquisite analyses of outbreaks but it's got a very retrospective mindset we need an agency with a much more operation focus with a Fidelity towards realtime information gathering and information dissemination and that can be CDC but we're going to need to build it we don't have it right now I think that there was this perception that CDC had this that they had the ball they would be able to

23:43 operationalize a national response to covid I think people had a misperception of what their capacities were what their resources were what their mission was so we're going to need to build a much more operationally focused agency it's going to look something like the current CDC married to a Fe or married to something that looks more like the dod where you have an operational and National Security aspect to the public health work thank you Scott this has been great I really enjoyed your book uncontrolled spread thanks a lot thanks for having me if you enjoyed today's episode you can listen or subscribe for free on Apple podcasts or wherever you listen if you would like to receive information on upcoming episodes be sure to sign up for our newsletter at 3 takeaway.com or follow us on Twitter Instagram Facebook and Linkedin note that thre takeaway.com is with the number three three is not spelled out for all social

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Questions about this episode

Who speaks in "#59 Why COVID Crushed Us & How To Defeat Future Pandemics: Former FDA Commissioner Scott Gottlieb"?

Lynn Tommen (Host), Scott Gottlieb (Guest).

What is "#59 Why COVID Crushed Us & How To Defeat Future Pandemics: Former FDA Commissioner Scott Gottlieb" about?

Former FDA Commissioner Scott Gottlieb discusses the systemic failures in the U.S. government's pandemic preparedness that contributed to the COVID-19 crisis, emphasizing the focus on influenza over other pathogens like coronaviruses. He outlines lessons learned and strategies for better handling future health emergencies, including potential threats from emerging viruses or bioengineered agents.

What is mentioned in this 3 Takeaways episode?

6 people, works and ideas are mentioned, including Uncontrolled Spread, Lynn Toman, CDC, FDA, Astra Zeneca, Department of Defense. Each one on this page links to its own page with every episode that mentions it.

How long is "#59 Why COVID Crushed Us & How To Defeat Future Pandemics: Former FDA Commissioner Scott Gottlieb"?

The episode runs 25 min; the transcript is about 4,711 words in 30 timestamped sections.

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