Rebuilding Trust After The COVID-19 Pandemic With Dr. Martin Kulldorff
Interview By Abdi Osman
Credits: Thérèse Soukar
HHPR Associate Editor Abdi Osman interviewed Dr. Martin Kulldorff, Ph.D., who previously was a Professor of Medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics at Harvard Medical School. Currently, Dr. Kulldorff is the senior scientific director at the Brownstone Institute and a fellow at Hillsdale College’s Academy for Science and Freedom. Dr. Kulldorff received his Bachelor of Science in Mathematical Statistics from Umea University and his Ph.D. in Operations Research from Cornell University. He is a part of the FDA’s Drug Safety and Risk Management Advisory Committee and worked with the CDC to develop statistical methods for their Vaccine Safety Datalink project. The interview below has been edited for concision and clarity.
Abdi Osman (AO): Thank you for speaking with me, Dr. Kulldorff. Your background in both vaccine safety and developing statistical methods for surveying diseases and viruses like COVID-19 is impressive. Could you tell me and the readers a little bit about your academic journey as a biostatistician?
Dr. Martin Kulldorff (MK): Soon after I got my Ph.D., I was approached by two medical doctors who were interested in the geographical distribution of leukemia to see if there were any clusters, so I developed some methods that are now widely used around the world for looking at the geographical patterns of disease. In that particular case, we didn't find any clusters, it was just randomly distributed, but especially for infectious diseases, you can use these methods to quickly detect disease outbreaks. For example, I think it was in 2015, there was a big outbreak of Legionnaires disease in New York City, and they used the methods that I’ve developed to detect this outbreak of Legionnaires disease in the Bronx.
It's important to detect those things early because the earlier you detect them, the sooner you can start investigating what's causing it. In this case, it turned out to be a cooling tower that was spreading it around the neighborhood, but of course it could’ve been something else, so the sooner you know that there's a problem, the sooner you can start investigating what's causing the problem.
AO: Thank you for that insight. I wanted to shift the discussion to your Brownstone Institute article: “Vaccines Save Lives”. Why do you think there is such a focus on vaccinating everybody for COVID-19, including young children, instead of focusing more on high risk groups such as the elderly?
MK: I’m not entirely sure. One thing that I believe is a key aspect of COVID-19 is that while anybody can get infected, there is more than a 1000-fold difference in the risk of dying from it among the oldest versus the youngest. This is something we’ve known from the very beginning in the spring and winter of 2020. For older people, this vaccine is very important, because we know the vaccine can prevent death for this group. However, for younger people, it is not so clear cut, because for older people, even if there are small risks from the vaccine that we may not know about yet, the benefits far outweigh the risks. In the case of children, we don't know these risks yet as it takes time to learn the safety profile of a vaccine, but we do know there's a very minuscule risk for mortality from COVID-19 for this group.
It's not clear what the risks and benefits are for younger people, and I think that public health authorities have made a huge mistake by pushing it for everybody instead of just focusing on older people. For example, there have been mandates for people working to get vaccinated, and the bill also mandated for students and some children too as well. However, the people who really need it are retired people and for them, there are no mandates. The focus should have been on reaching older people and by making a huge controversy with mandates, and I believe that a lot of older people refused the vaccine because of that. I think that those vaccine fanatics who have been pushing this vaccine have actually damaged vaccine confidence in the country. Not just for the COVID-19 vaccine, but other very important vaccines such as the measles vaccine, polio vaccine, and so on.
AO: It would seem to some people, specifically older folks, that this stopped being about health and more about control. I guess that, as you said, maybe older people feel very hesitant about it because they feel as though this isn't about their health and is instead about having control over their bodily autonomy, and not taking the vaccine was a way of resisting that.
MK: Yes and also, when public health officials say things that turn out to be wrong, then that leads to distrust of public health agencies like the CDC. That's a very serious problem because that trust is important and it's also important that it goes both ways. So yes, we want the public to trust the public health agencies, but we also want public health agencies to trust the public because you can't have one without the other, it has to be equal in both ways. For example, I'm a native of Sweden, and Sweden doesn't have vaccine mandates, but it has one of the highest vaccination rates in the world, and this is just historically for vaccines that is achieved through trust instead of through mandates.
AO: How do you think we can resolve this distrust, specifically within America, that many have for the institutions and professionals that handled the pandemic, especially regarding vaccine safety?
MK: I think the first thing is to be very truthful and honest even if it's about someone with adverse reactions. We have to be very honest about it because there are some adverse reactions from the COVID-19 vaccine such as myocarditis, which is the inflammation of the heart. We not only have to be very honest and truthful about these kinds of things, but we also have to be more transparent. We have a system called VAERS, the vaccine adverse event reporting system, where anybody can report if they think that the vaccine may have caused some adverse reaction and that person can be a doctor, nurse, patient, or family member; of course, these reports don't mean that there was a causal relationship. We get all these reports and these are made public by the CDC and FDA, but that leads to a lot of concern because they see all these reports, but they may or may not be causal to the vaccine. The CDC and FDA, in turn, create a lot of problems because they just give the raw data publicly without actually doing any solid analysis to see if the numbers reported are higher than what you would expect by chance, and it's not so easy to do that given the nature of the data, but one could do better than what they are doing.
One important thing is that two other systems, the Vaccine Safety Datalink (VSD) system that the CDC uses and the FDA’s BEST (Biologics Effectiveness and Safety) system, are much better because you can compare the observed rates without underreporting with what is expected by chance. What happens in the VSD system, for example, is that you have data from health plans, so you not only know everybody who got vaccinated and on what day, but you also know all the subsequent medical encounters. So, if they come in after a stroke or seizure or so five days after the vaccine, you can begin to ask if there is a higher risk because of the vaccine versus what you would expect by chance.
These kinds of systems exist and I believe the results from them should be continuously made public; however, that’s currently not the case. Instead, we get occasional information from them and it’s not continuously publicly available. If that were the case, I think that would help with confidence as if a vaccine is safe, there are no adverse reactions, only mild or rare adverse reactions, and you want to show that so that people trust the vaccines. At the same time, if there is a problem, you want to detect it quickly and announce it as soon as possible so that people can make informed decisions about the risks and benefits. For the CDC, I think to convince people or be more credible on these issues, they have to continuously publish public reports from these superior systems.
AO: It feels as though the CDC is at a point now where their reputation is just continuously going downhill. They don't seem to want to concede that a lot of the ideas that they've pushed forward since the beginning of the pandemic have been wrong and would rather just keep going with whatever their experts and professionals are saying. I’m not entirely sure, but it seems like the CDC has to start admitting that they were wrong in order to help build this trust again.
MK: No, I think you're right. If they want to rebuild that trust, they need to admit that they were wrong and also stop making claims for things that we don't have strong evidence for. One example is that the previous CDC director claimed that masks were more beneficial than vaccines, which is of course nonsense because we know that vaccines can prevent hospitalizations and deaths. There have been no good studies for masks actually showing this prevention of hospitalizations and deaths as there have been only two randomized trials on masks and COVID-19, and one of them had a negative result to ensure efficacy. The other study was from Denmark, and the negative results one was from Bangladesh, and their research showed that masks reduced transmissions between 0 and 18%, basically no effect to very limited effect.
That was one problem; the other one is that the current CDC director signed a document a year and a half ago questioning whether there was natural immunity after having recovered from COVID-19. We not only knew then that there was good immunity after recovering from COVID-19, but we’ve also known since 430 BCE with the Athenian plague that after recovering from infectious diseases, people are often immune. It's not a surprise that people are immune after COVID-19 and we now have studies showing that this immunity after having recovered from COVID-19 is superior to the immunity after the vaccine, which is exactly what you would expect. I think the CDC lost a lot of trust when they didn't recognize this and when they questioned herd immunity along with when they imposed vaccine mandates for people who already had COVID-19 as those vaccines could’ve been used for other people who needed them more. When you vaccinate a 22-year-old student at Harvard, who already had COVID-19, that means that there are fewer doses available for, let’s say, a 75-year-old woman in India, who hasn't had COVID-19 and who needs the vaccine to be protected.
AO: To quickly jump back to your mention of Sweden earlier, do you feel as though America should have taken a similar approach to the pandemic like Sweden, that being a more relaxed view on measures such as lockdowns and masking?
MK: I think Sweden got it right and of course, was criticized heavily at the beginning of the pandemic, but I think now we know that they made the right decisions as they currently have one of the lowest COVID-19 mortality rates. It's also not just Sweden, but the whole of Scandinavia that took a much lighter approach, and they too have had lower COVID-19 mortality compared to the vast majority of countries in Europe. It’s also important to note that the ultimate measure is not COVID-19 mortality because they can be defined differently in different countries, but rather excess mortality because you can't fudge those numbers. These Scandinavian countries also have had less excess mortality than other European countries and also less than the United States.
One of the things that we failed with during this pandemic was not upholding a key principle of public health, which is that public health is not about a single disease, it's about all aspects of health. What we did was that we focused all our efforts on suppressing COVID-19, which cannot be suppressed and any competent professional knew at the beginning of 2020 that this was a virus that's impossible to suppress. We attempted to suppress it anyway and failed, leading to an enormous amount of collateral damage to our public health whereas Sweden had less of that collateral damage, much less. An example of this collateral damage is people not getting their cervical cancer screenings or diabetes treatment. We have also seen worse cardiovascular health outcomes during the pandemic. Not only that but there have been many problems with mental health for both the young and the old, especially vulnerable people like children with autism, who were hit very hard by the lockdown measures that were implemented.
You can't just think of one disease like COVID-19, you have to think of public health as a whole and if we look at the numbers from 2020, we saw that there was excess mortality in the US, and among the older people, the excess mortality was about the same as the reported COVID-19 mortality. If we looked at people in their 40s, we saw that the excess mortality in that age group was much larger than the reported COVID-19 mortality which could’ve been due to underreporting, but that's unlikely because then you would've seen underreporting in the elderly as well. These are people who died from an opioid overdose, for example, or other things such as heart issues that weren't taken care of in a timely manner. These excess deaths were also among younger people which was primarily due to the lockdowns, so these measures the US took caused a lot of unnecessary harm to public health.
The unfortunate thing is another principle of public health is we can't just only think about the short-term, we also have to think about the long-term. We attempted to minimize short-term COVID-19 infections, but we haven't fully seen yet a lot of the collateral damage from doing this, or it’s not in the data yet. For example, if you don't get your cancer screening, that's not going to kill you this year, but let’s say a woman that would’ve lived at least another 15 to 20 years might die 3 or 4 years from now due to not being able to get a screening.
In the end, this collateral public health damage is something that we're going to have to live and die with for many years to come. Not to mention, the damage to education for children has also been terrible because you can't just magically restore the schooling that they missed, with some places missing up to two years. I think if there was one thing that I would like to change in the pandemic response, it would be to not have closed down the schools as they should’ve been opened from day one. We knew that based on data from Sweden, they kept all the daycare schools open throughout the spring of 2020 for all children ages 1 to 15 and there was a report by the Public Health Agency in Sweden, I think it was in June or July, where they reported this data and showed that among the 1.8 million students during this time, there was exactly 0 COVID-19 deaths and only a handful of hospitalization. We knew about this in the early summer of 2020, but then the New England Journal of Medicine published a report on whether schools should be opened or closed and they didn't even mention the data from Sweden, which was the only major western country that kept schools open. This is like doing a clinical trial for a drug and not comparing it to a placebo group.
Again, we already knew in the summer of 2020 that it was safe to keep schools open and in Sweden, they kept them open without masks and social distancing. If a child was sick for anything they would've just send them home with no testing; if a child was already sick, they were supposed to stay home, whether they had COVID-19 or not. That was the one COVID-19 measure that we implemented in the schools which I thought was sound. Even with all the data we received from Sweden so early on, it's astonishing to me that schools continued to be closed after that.
AO: Aside from the lockdowns and especially the school closures, do you feel it was safe to accelerate the development and rollout of the COVID-19 vaccine based on available trial results? If I remember, President Trump touted “Operation Warp Speed” as a success in developing the vaccines in a quick, safe, and effective manner. What are your thoughts?
MK: I think it was impressive that we were able to develop the vaccine so quickly. There were a few problems, though. One issue was that when the clinical trials were designed, they made it so that it would determine whether it reduces symptomatic infections; however, that’s not an important issue, rather it’s more important to reduce mortality primarily, as well as hospitalizations. The clinical trials showed that the vaccine had very good short-term efficacy on symptomatic disease, but they did not show whether the vaccines reduced mortality and the reason was that they were not designed to do that due to these trials. Most of the participants in the randomized trials were adults in their 40s, 50s, and 60s, and they all had a low risk of mortality, whether they were vaccinated or not. There were very few deaths in those groups, both in the vaccinated and unvaccinated, but there were also very few people in the trials over the age of 70; if they had wanted to evaluate the importance of the outcome of mortality, then Pfizer, Moderna, and Johnson & Johnson would have designed the trials with more older people and then we could have answered the question if it had reduced mortality from the clinical trials.
The other mistake that was made was that they ended the trials too soon. Once they had shown efficacy on symptomatic infections, they decided to give all the people in the placebo group the vaccine and that means that now that the clinical trial has ended, you can’t compare the long-term consequences of these vaccines anymore. Therefore, we didn't get any information on how long-lasting these vaccines are, but we know from observational studies that the protection against infection and symptomatic disease wanes very rapidly, which is why they are pushing boosters. Not only that but also the protection against death and hospitalization wanes, though not quite as rapidly.
Of course, the clinical trials also didn't show whether they would reduce transmission because they didn't ask this question, but they could’ve if they wanted to. They could have ran a trial where they evaluated whether it reduced transmission, but they didn't. That was another problem with these trials and then, of course, when the CDC goes out and claims that it prevents transmission and it turns out to be wrong, that means the CDC loses credibility.
AO: One last question that I have for you is: if you were in charge of the entire COVID-19 program for America, what would you do today?
MK: Well, I think the pandemic is moving towards being endemic, so the virus is never going to go away and we are going to live with it for the rest of our lives, just like we live with the four other common coronaviruses. Most people are going to be exposed for the first time when they are children, in which case this is a very mild disease and once you have been exposed, you will have good immunity that will then give you protection through the rest of your life; this doesn’t necessarily mean that you won't get infected again or get something symptomatic like a cold, but it will prevent you from serious outcomes. Maybe when you're 93 years old, your immune system is so weak that maybe you will die from COVID-19, influenza, or some other virus, as we have seen in the past. That's sort of the future of COVID-19, and I think we should be very thankful that this pandemic is such that the children suffered minuscule risks and not the severe outcomes of this disease.
I think one key thing is that we accept COVID-19 as just one of many pathogens that we have lived with for hundreds of years. I also think, psychologically, we have to move to that mindset. Secondly, the other thing that I think is very important is we have to put in enormous efforts to build back public health and to minimize the collateral damage from our COVID-19 measures; for example, improving cancer screenings, treatments for cardiovascular diseases, diabetes treatment, and especially mental health treatment, which is something that has an enormous backlog of work for medical professionals to deal with due to the pandemic.
We have also seen that there have been plummeting vaccination rates among children, so we have to try to catch up with that and that's true both in the US and around the world. We have to do our best to rebuild and compensate for all this collateral damage that we have seen; of course, we also have to make sure that these failures during this pandemic are not repeated during the next pandemic. We have to learn from this pandemic, and I think it's important that we learn from history and that people realize what went wrong and why it went wrong, but I also feel as though there's a lot of soul searching needed to be done for that.
AO: That’s all I have for you today. Thank you for your time Dr. Kulldorff, it was an absolute pleasure talking to you, and I’m certain our readers will enjoy your wonderful insights.
