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Bill Gates predicted a pandemic in 2018. Now that COVID-19's arrived, here's how he wants to control it.

Gates: Lack of leadership and inconsistency for drug, vaccine trials have slowed down U.S. response

Bill Gates, co-chair of the Bill and Melinda Gates Foundation, points out flaws in the national response to COVID-19 at an Oct. 21 Fireside Chat hosted by Stanford Medicine. Courtesy Stanford Medicine.

Microsoft co-founder Bill Gates implicated a lack of leadership in the United States' response to the COVID-19 pandemic, inconsistency in the country's overall strategy to control the virus and persistent misinformation as threats to controlling the deadly coronavirus during an Oct. 21 livestreamed interview with Dr. Lloyd Minor, Stanford School of Medicine's dean of medicine.

Gates, who is co-chair of the Bill & Melinda Gates Foundation, predicted years ago that a pandemic caused by an alien pathogen would spread across the globe. His prediction wasn't pulled out of the ether. Gates has been involved in preventing the spread of dangerous diseases for more than 20 years.

The foundation works on solutions to develop inexpensive medications and vaccines to treat persistent infectious diseases such as human immunodeficiency virus (HIV), polio and malaria in poor and underserved countries. Gates' work with the foundation led him early on to predict the current pandemic, which would likely be an unknown pathogen that would be seen for the first time, he said during an April 2018 Shattuck Lecture in Boston, Massachusetts.

Gates said at Stanford last month that the emergence of infectious diseases such as swine flu in 2009, the Ebola in 2014, Middle East respiratory syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) made him pay closer attention to pandemics. The conclusion he came to during those outbreaks was that the world was not making progress in its pandemic preparedness.

Fast forward to 2020 and Gates's predictions have come true with frightening accuracy.

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"It's sad that this took a Richter-scale 9 earthquake to wake us up," Gates told Minor. "We've had, outside of the rich countries, things like Ebola, Zika, MERS and SARS, but it was easy to just kind of ignore those things" because they were never really at the doorstep of the wealthier nations.

A scattershot approach to the COVID-19 crisis that has largely been without leadership, combined with the power of social media, has caused confusion and perhaps delayed treatments that would more meaningfully save lives, he said.

"Weirdly, antivirals and monoclonal antibodies, such as (antiviral drug) remdesivir, were used on late-stage patients. It's not surprising that the impact on mortality is very low there. So the whole thing of how we trial different drugs against early or late (disease progression) in the U.S. has been a complete disaster on that. Even disproving hydroxychloroquine (a treatment much touted by President Donald Trump) took us way too long," he said.

Getting access to that early-stage patient is hard, he conceded, since many who have symptoms might not show up in hospitals until their condition worsens. "It's easier to get the later-stage patient. But even for the late-stage patient, we had all these small trials that had different mixes of drugs and different requirements for enrollment, so it's just been a cacophony and there hasn't been any clarity about who's in charge of organizing these trial efforts," he said.

Who is in charge of organizing the drug and vaccine trials — and who should be — has remained murkey. The U.S. Centers for Disease Control and Prevention doesn't organize drug and vaccine trials. The Food and Drug Administration is the regulator that is not supposed to organize trials, but instead review trials to make sure they're done well. The National Institutes of Health handles research, so the country didn't really figure out who should be in charge of organizing the trials, he said.

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Gates does see hope in emerging drugs and vaccines to reduce serious infections and deaths from COVID-19.

"The most promising drugs are monoclonal antibodies (a cloned, type of white blood cell specific to fighting a pathogen), which — if you catch somebody early who just tested positive and has a pulse/oxygen decline and you're old — giving (them) antibodies either through infusion or a couple of shots probably will be able to reduce the death rate by 70%-80%," he said.

The foundation has been working on a potential two-shot, low-dose antibody treatment with drugmaker Eli Lilly, he said. Biotechnology company Regeneron is also testing a two-shot treatment, he said. By the end of this year, hopefully, there will be an early-stage treatment using antibodies that would be available, he said.

"Particularly if it's a low-dose intervention, that is really a big deal in reducing overall deaths," he said, noting that side effects might be minimal and supplies could be scaled up rapidly.

When and if a viable vaccine is discovered, Gates said there will be challenges to getting an adequate number of people to take it.

"We've always had a tough time with that," he said. Explaining the rigorous testing process for vaccines and how miraculous they are is often a tough sell against a backdrop of conspiracy theories. The fact that the pandemic came at the same time that social media is widespread has helped fuel falsehoods and misinformation, he added.

"Bizarrely — I hope not tragically — by demonizing Dr. (Anthony) Fauci and myself, who are the two most prominently mentioned in some of these inaccurate theories, it could drive people to not wear masks as much or to not be willing to seek out the vaccine. We have to offset that by being creative about (getting out) the truthful message: the heroes who invent the vaccine; the facts about how the safety trials are done. We're going to have to push ourselves on this," he said.

Gates said he thinks public confidence can be boosted through input from outside experts and companies involved in the development of vaccines and drugs, but "when the politicians act like they want a certain outcome — even naming something 'Operation Warp Speed' — they are defining expectations that aren't balanced."

"It's not just the time; it's the safety and efficacy as well," he said.

Much of the problem has come from a blurring of the boundaries between science and politics.

"In this epidemic, sadly, the boundary between what's the regulators' and what's the politicians' has been broken," he said. To gain public trust, "we always have to admit what we don't know. We have to be willing to deliver bad news. Politicians aren't ... as good at sharing the truth and that can be a problem. That's usually why you delegate (the role as messenger) to scientists who are trained to do this," he said.

Gates said he has hope that once people see a vaccine works, more will seek immunization.

"I think in the United States my hope is that 20% to 30% of the population will be willing to take the vaccine early on, knowing that they're helping their fellow citizens by the transmission-blocking benefits that the vaccine brings," he said. If others see that there are very few side effects in that 20% to 30%, it would build confidence.

He's more cautious about whether public perceptions of vaccines might be repaired in the future after so much misinformation.

"How much, after we get out of this emergency situation, we'll be able to restore broad respect for vaccines and health advice, I'm not certain," he said.

Gates also said it's imperative to rebuild stronger public health programs. From what he's seen in other countries, basic public health infrastructure breaks down quickly when a pandemic occurs, so there needs to be a coordinated global approach.

The pandemic must be assessed in broader contexts, he added. If the focus is on deaths caused by COVID-19, the country and the globe will miss the scope and the setbacks caused by the virus and what course the recovery should take, he said.

"One thing I underestimated was how quickly people's behavior would change … when death stalks the land — when you've got over 2,000 (deaths) a day," he said, noting the changes to work habits, business closures, school closures and mental health issues caused by confinement.

The COVID-19 pandemic's impact on the economy is greater than he had anticipated in 2015, when he predicted a $3 trillion loss. "We could easily get to $10, maybe $15 trillion over the next two years," he said.

To Gates, the tragedy of the pandemic and its impacts again point back to the government's failed messaging early on.

"By not having the federal government say early on we need to intervene aggressively, we missed what capacity there is in the CDC to minimize the epidemic and be like one of those other countries (Australia, New Zealand), which got an early handle on the virus, he said.

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Bill Gates predicted a pandemic in 2018. Now that COVID-19's arrived, here's how he wants to control it.

Gates: Lack of leadership and inconsistency for drug, vaccine trials have slowed down U.S. response

by / Palo Alto Weekly

Uploaded: Tue, Nov 10, 2020, 6:09 pm

Microsoft co-founder Bill Gates implicated a lack of leadership in the United States' response to the COVID-19 pandemic, inconsistency in the country's overall strategy to control the virus and persistent misinformation as threats to controlling the deadly coronavirus during an Oct. 21 livestreamed interview with Dr. Lloyd Minor, Stanford School of Medicine's dean of medicine.

Gates, who is co-chair of the Bill & Melinda Gates Foundation, predicted years ago that a pandemic caused by an alien pathogen would spread across the globe. His prediction wasn't pulled out of the ether. Gates has been involved in preventing the spread of dangerous diseases for more than 20 years.

The foundation works on solutions to develop inexpensive medications and vaccines to treat persistent infectious diseases such as human immunodeficiency virus (HIV), polio and malaria in poor and underserved countries. Gates' work with the foundation led him early on to predict the current pandemic, which would likely be an unknown pathogen that would be seen for the first time, he said during an April 2018 Shattuck Lecture in Boston, Massachusetts.

Gates said at Stanford last month that the emergence of infectious diseases such as swine flu in 2009, the Ebola in 2014, Middle East respiratory syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) made him pay closer attention to pandemics. The conclusion he came to during those outbreaks was that the world was not making progress in its pandemic preparedness.

Fast forward to 2020 and Gates's predictions have come true with frightening accuracy.

"It's sad that this took a Richter-scale 9 earthquake to wake us up," Gates told Minor. "We've had, outside of the rich countries, things like Ebola, Zika, MERS and SARS, but it was easy to just kind of ignore those things" because they were never really at the doorstep of the wealthier nations.

A scattershot approach to the COVID-19 crisis that has largely been without leadership, combined with the power of social media, has caused confusion and perhaps delayed treatments that would more meaningfully save lives, he said.

"Weirdly, antivirals and monoclonal antibodies, such as (antiviral drug) remdesivir, were used on late-stage patients. It's not surprising that the impact on mortality is very low there. So the whole thing of how we trial different drugs against early or late (disease progression) in the U.S. has been a complete disaster on that. Even disproving hydroxychloroquine (a treatment much touted by President Donald Trump) took us way too long," he said.

Getting access to that early-stage patient is hard, he conceded, since many who have symptoms might not show up in hospitals until their condition worsens. "It's easier to get the later-stage patient. But even for the late-stage patient, we had all these small trials that had different mixes of drugs and different requirements for enrollment, so it's just been a cacophony and there hasn't been any clarity about who's in charge of organizing these trial efforts," he said.

Who is in charge of organizing the drug and vaccine trials — and who should be — has remained murkey. The U.S. Centers for Disease Control and Prevention doesn't organize drug and vaccine trials. The Food and Drug Administration is the regulator that is not supposed to organize trials, but instead review trials to make sure they're done well. The National Institutes of Health handles research, so the country didn't really figure out who should be in charge of organizing the trials, he said.

Gates does see hope in emerging drugs and vaccines to reduce serious infections and deaths from COVID-19.

"The most promising drugs are monoclonal antibodies (a cloned, type of white blood cell specific to fighting a pathogen), which — if you catch somebody early who just tested positive and has a pulse/oxygen decline and you're old — giving (them) antibodies either through infusion or a couple of shots probably will be able to reduce the death rate by 70%-80%," he said.

The foundation has been working on a potential two-shot, low-dose antibody treatment with drugmaker Eli Lilly, he said. Biotechnology company Regeneron is also testing a two-shot treatment, he said. By the end of this year, hopefully, there will be an early-stage treatment using antibodies that would be available, he said.

"Particularly if it's a low-dose intervention, that is really a big deal in reducing overall deaths," he said, noting that side effects might be minimal and supplies could be scaled up rapidly.

When and if a viable vaccine is discovered, Gates said there will be challenges to getting an adequate number of people to take it.

"We've always had a tough time with that," he said. Explaining the rigorous testing process for vaccines and how miraculous they are is often a tough sell against a backdrop of conspiracy theories. The fact that the pandemic came at the same time that social media is widespread has helped fuel falsehoods and misinformation, he added.

"Bizarrely — I hope not tragically — by demonizing Dr. (Anthony) Fauci and myself, who are the two most prominently mentioned in some of these inaccurate theories, it could drive people to not wear masks as much or to not be willing to seek out the vaccine. We have to offset that by being creative about (getting out) the truthful message: the heroes who invent the vaccine; the facts about how the safety trials are done. We're going to have to push ourselves on this," he said.

Gates said he thinks public confidence can be boosted through input from outside experts and companies involved in the development of vaccines and drugs, but "when the politicians act like they want a certain outcome — even naming something 'Operation Warp Speed' — they are defining expectations that aren't balanced."

"It's not just the time; it's the safety and efficacy as well," he said.

Much of the problem has come from a blurring of the boundaries between science and politics.

"In this epidemic, sadly, the boundary between what's the regulators' and what's the politicians' has been broken," he said. To gain public trust, "we always have to admit what we don't know. We have to be willing to deliver bad news. Politicians aren't ... as good at sharing the truth and that can be a problem. That's usually why you delegate (the role as messenger) to scientists who are trained to do this," he said.

Gates said he has hope that once people see a vaccine works, more will seek immunization.

"I think in the United States my hope is that 20% to 30% of the population will be willing to take the vaccine early on, knowing that they're helping their fellow citizens by the transmission-blocking benefits that the vaccine brings," he said. If others see that there are very few side effects in that 20% to 30%, it would build confidence.

He's more cautious about whether public perceptions of vaccines might be repaired in the future after so much misinformation.

"How much, after we get out of this emergency situation, we'll be able to restore broad respect for vaccines and health advice, I'm not certain," he said.

Gates also said it's imperative to rebuild stronger public health programs. From what he's seen in other countries, basic public health infrastructure breaks down quickly when a pandemic occurs, so there needs to be a coordinated global approach.

The pandemic must be assessed in broader contexts, he added. If the focus is on deaths caused by COVID-19, the country and the globe will miss the scope and the setbacks caused by the virus and what course the recovery should take, he said.

"One thing I underestimated was how quickly people's behavior would change … when death stalks the land — when you've got over 2,000 (deaths) a day," he said, noting the changes to work habits, business closures, school closures and mental health issues caused by confinement.

The COVID-19 pandemic's impact on the economy is greater than he had anticipated in 2015, when he predicted a $3 trillion loss. "We could easily get to $10, maybe $15 trillion over the next two years," he said.

To Gates, the tragedy of the pandemic and its impacts again point back to the government's failed messaging early on.

"By not having the federal government say early on we need to intervene aggressively, we missed what capacity there is in the CDC to minimize the epidemic and be like one of those other countries (Australia, New Zealand), which got an early handle on the virus, he said.

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