scientificamerican--2020-09-16--Anonymous Peer Review: Truth or Trolling?

In recent years , I have accepted growing responsibilities as a mentor of graduate students and post-doctoral researchers in my new research group .
I have been entrusted as the VP for ethics , diversity , equity and inclusion of an international scientific society , charged to be someone to support changes that can lead to leveling opportunities in academia .
In science , our careers are defined by the findings that we publish based on the research we do in the lab or in the field .
Being successful at both publishing and obtaining funds for research means being @ @ @ @ @ @ @ seeking to convince our peers of the excellence and originality of our research .
Each piece of work is generally assessed by at least three reviewers .
Since I have published 40 articles and obtained 10 grants , I must have passed the scrutiny of about 150 reviewers .
Because reviewing is a reciprocal process , meant to be a safeguarding space for valid scientific input , anonymous reviewing is the standard default option .
Anonymity should mean protection for the reviewer from retaliation and discrimination .
Otherwise , early-career scientists reviewing a @ @ @ @ @ @ @ may feel intimidated and voicing critical assessments from nonpermanent positions may be daunting .
But all of us have experienced , perhaps more often than not , the distorting effects of anonymity when it results in prejudiced reviews .
In some cases , these can have devastating effects on early careers and hit hard at fragile self-esteem .
As with trolling in social media , anonymity in peer review is sometimes used to say those things that would never be said if reviewers had to reveal their identity .
Experiencing rejection is the @ @ @ @ @ @ @ research is sound , it may not be good enough to make the top 10 percent cutoff of a journal , or our project may be exciting , but funds are limited , so that we lose in competition to more stellar science .
Rejection is difficult to digest , but we move on after each blow , abiding by the rules of the game we have accepted to play .
But , what to do when the game is sabotaged by players who seem to have created their own rules ?
At @ @ @ @ @ @ @ may be called the “ Reviewer # 2 phenomenon.
” Reviewer # 2 is someone who rejects any proposal or manuscript no matter who or what it may be , because you are trying to publish within their field of research or did not cite their work enough .
We all have dealt with Reviewer # 2 , in our roles as associate editors of journals or awards committees .
Would those Reviewer # 2s survive if they had to sign off their reviews ?
Perhaps so , but I predict their existence @ @ @ @ @ @ @ female , I offer the following example , as it came after seven years of overcoming challenges to continue in science : After giving birth a month before Ph.D. graduation , moving continents three times in 2.5 years , and then starting a research lab immediately thereafter , I found myself mostly focusing on helping students and postdocs to progress .
I finally found the courage to devise a novel project ( during a full-on teaching term ! )
, and I was looking forward to getting back to what excites me in @ @ @ @ @ @ @ the other three reviewers—would have marked an important milestone in my career .
Meet my Reviewer # 2 : They didn ’ t tick boxes about conflicts of interest , but assessing research that overlaps with their own topics always poses a difficult challenge .
Two reviewers said that the proposal is sound and fundable , while the fourth reviewer stated that my field really needs this project to be done .
So far , so good .
Reviewer # 2 instead resorted to a version of assessment that can be used only @ @ @ @ @ @ @ scrutiny otherwise .
Reviewer # 2 works in my field but seems not to have read about my subject species since the 1970s .
Reviewer # 2 is an expert in human evolution but claims that my statement about modern humans being obligate bipeds ( animals whose anatomy forces them to mostly walk upright rather than on all fours ) is incorrect ( ?
! )
.
Reviewer # 2 produces other mind-boggling ways to eviscerate the proposal—for example , by stating that I am wrong to say that bipedalism is a defining @ @ @ @ @ @ @ now I am seriously worried , as someone teaching human evolution in the university , I seem to have some of the most basic facts totally wrong !
I recheck my proposal : That sentence was a quote from Darwin .
The proposal was required to be short , but Reviewer # 2 wants a longer literature review and more citations ( of their work ? )
.
They make a few more comments tangential to the core of the project but provide no comments on my proposed analyses or hypotheses and…reject .
@ @ @ @ @ @ @ my first thought was “ I will not spend time writing another application anytime soon.
” And I know many students and colleagues who have pondered and concluded just that .
But I want us to revise and resubmit after such treatment , and I call for reformative action .
We need peer-reviewing processes that give accurate and constructive assessments and that appreciate the immense effort it takes to develop new ideas that yield new science .
Established academics , less prone to pressures , should be encouraged to reveal their identities , @ @ @ @ @ @ @ remain an option to ensure power balance .
More outlets that make public the entire review process alongside the published article , including communications with editors , combined reviewers ’ comments and rebuttal letters would maximize transparency .
Signing off reviews , either of manuscripts or grants , could help leveling-up the quality of the peer-review process and contribute to ending the unethical trolling that truncates or damages careers .

In recent years, I have accepted growing responsibilities as a mentor of graduate students and post-doctoral researchers in my new research group. I have been entrusted as the VP for ethics, diversity, equity and inclusion of an international scientific society, charged to be someone to support changes that can lead to leveling opportunities in academia.
In science, our careers are defined by the findings that we publish based on the research we do in the lab or in the field. Being successful at both publishing and obtaining funds for research means being on a lifelong path of scrutiny, seeking to convince our peers of the excellence and originality of our research. Each piece of work is generally assessed by at least three reviewers. Since I have published 40 articles and obtained 10 grants, I must have passed the scrutiny of about 150 reviewers.
Because reviewing is a reciprocal process, meant to be a safeguarding space for valid scientific input, anonymous reviewing is the standard default option. Anonymity should mean protection for the reviewer from retaliation and discrimination. Otherwise, early-career scientists reviewing a grant submitted by a large senior team may feel intimidated and voicing critical assessments from nonpermanent positions may be daunting.
But all of us have experienced, perhaps more often than not, the distorting effects of anonymity when it results in prejudiced reviews. In some cases, these can have devastating effects on early careers and hit hard at fragile self-esteem. As with trolling in social media, anonymity in peer review is sometimes used to say those things that would never be said if reviewers had to reveal their identity.
Experiencing rejection is the norm in academia: even when our research is sound, it may not be good enough to make the top 10 percent cutoff of a journal, or our project may be exciting, but funds are limited, so that we lose in competition to more stellar science. Rejection is difficult to digest, but we move on after each blow, abiding by the rules of the game we have accepted to play. But, what to do when the game is sabotaged by players who seem to have created their own rules?
At the core of this discussion is what may be called the “Reviewer#2 phenomenon.” Reviewer#2 is someone who rejects any proposal or manuscript no matter who or what it may be, because you are trying to publish within their field of research or did not cite their work enough. We all have dealt with Reviewer#2, in our roles as associate editors of journals or awards committees. Would those Reviewer#2s survive if they had to sign off their reviews? Perhaps so, but I predict their existence would decline sharply.
As an early-career female, I offer the following example, as it came after seven years of overcoming challenges to continue in science: After giving birth a month before Ph.D. graduation, moving continents three times in 2.5 years, and then starting a research lab immediately thereafter, I found myself mostly focusing on helping students and postdocs to progress. I finally found the courage to devise a novel project (during a full-on teaching term!), and I was looking forward to getting back to what excites me in science. This project could and—according to the other three reviewers—would have marked an important milestone in my career.
Meet my Reviewer#2: They didn’t tick boxes about conflicts of interest, but assessing research that overlaps with their own topics always poses a difficult challenge. Two reviewers said that the proposal is sound and fundable, while the fourth reviewer stated that my field really needs this project to be done. So far, so good. Reviewer#2 instead resorted to a version of assessment that can be used only under anonymity; it would not stand scrutiny otherwise.
Reviewer#2 works in my field but seems not to have read about my subject species since the 1970s. Reviewer#2 is an expert in human evolution but claims that my statement about modern humans being obligate bipeds (animals whose anatomy forces them to mostly walk upright rather than on all fours) is incorrect (?!).
Reviewer#2 produces other mind-boggling ways to eviscerate the proposal—for example, by stating that I am wrong to say that bipedalism is a defining feature of the hominin clade. By now I am seriously worried, as someone teaching human evolution in the university, I seem to have some of the most basic facts totally wrong! I recheck my proposal: That sentence was a quote from Darwin. The proposal was required to be short, but Reviewer#2 wants a longer literature review and more citations (of their work?). They make a few more comments tangential to the core of the project but provide no comments on my proposed analyses or hypotheses and…reject. Sigh.
After reading this review, my first thought was “I will not spend time writing another application anytime soon.” And I know many students and colleagues who have pondered and concluded just that. But I want us to revise and resubmit after such treatment, and I call for reformative action. We need peer-reviewing processes that give accurate and constructive assessments and that appreciate the immense effort it takes to develop new ideas that yield new science.
Established academics, less prone to pressures, should be encouraged to reveal their identities, while anonymity for young scientists ought to remain an option to ensure power balance. More outlets that make public the entire review process alongside the published article, including communications with editors, combined reviewers’ comments and rebuttal letters would maximize transparency. Signing off reviews, either of manuscripts or grants, could help leveling-up the quality of the peer-review process and contribute to ending the unethical trolling that truncates or damages careers.


scientificamerican--2020-09-16--Population Density Does Not Doom Cities to Pandemic Dangers

In the early months of the COVID-19 pandemic , some U.S. leaders and pundits pointed to hard-hit cities such as New York , Milan and Wuhan as proof that population density was to blame for coronavirus hotspots .
But simple density has not adequately predicted the disease ’ s course in the U.S. , where the new coronavirus has spread well beyond urban areas to ravage rural communities and suburbs during the country ’ s long summer .
Many public health and urban planning researchers agree that the concentration of people within a certain area does not tell the whole @ @ @ @ @ @ @ high-density cities , including Hong Kong , Seoul and Taipei , where robust and widespread interventions ( such as social distancing , mask wearing and contact tracing ) successfully limited COVID-19 cases and deaths .
And studies conducted amid the pandemic suggest that other factors—connections among communities , access to health care and crowding within a small area , for example—can also strongly influence how the disease spreads and how residents fare .
“ Since the early days of the pandemic , there have been a number of articles speculating whether COVID-19 will @ @ @ @ @ @ @ and ] some articles suggested that COVID-19 was spurring an exodus from cities to suburbs as a way to escape the ... virus , ” says Deepti Adlakha , an environmental health researcher at Queen ’ s University Belfast .
“ And from the beginning , these struck me as the wrong questions to ask.
” For one thing , the population density of a city or county does not capture the finer points of how people actually gather within smaller spaces , such as those on college campuses or in individual residential @ @ @ @ @ @ @ talk about density and COVID-19 , they ’ re really talking about crowding , ” says Shima Hamidi , an assistant professor of environmental health and engineering at Johns Hopkins University .
Sometimes crowding occurs when people gather for events such as concerts or parties , notes Ann Forsyth , an urban planner at Harvard University .
Crowding can also result from socioeconomic conditions that force many people to live in a small space or from cultural preferences for living in multigenerational households .
Buses and other forms of mass transit can also @ @ @ @ @ @ @ areas .
Not every crowding situation leads to widespread viral transmission .
But some have turned out to be superspreader events in a diverse array of settings in the U.S .
These occurrences have included a suburban house party in Connecticut , a biotech conference at a Boston hotel , a Bible study session at a rural Arkansas church , and overnight summer camps in Georgia and Missouri .
“ The virus can spread very efficiently in crowds .
It does n't seem to always happen , but it can happen , ” @ @ @ @ @ @ @ University epidemiologist .
High-density cities may offer more opportunities for crowding .
But in Asia , proper public health precautions have spared many megalopolises from the worst .
Even in hard-hit New York City , Manhattan has maintained the lowest COVID-19 rates among the city ’ s five boroughs , despite having the highest population density .
Meanwhile some lower-density neighborhoods in Queens and the Bronx have seen higher rates of infection and death .
Hamidi looked at some of the confounding factors—metropolitan size , socioeconomic status of residents , quality of health @ @ @ @ @ @ @ how density affects COVID-19 spread and mortality in more than 900 U.S. counties .
She and her collaborators at the University of Utah found that county density had no significant relationship with infection rate .
In fact , higher-density counties were actually associated with lower mortality rates , possibly because residents were more strictly following social-distancing guidelines or had better access to health care .
“ If you want to move to a rural area to be safe from getting COVID , maybe [ that helps ] because you have fewer contacts , @ @ @ @ @ @ @ economist at Boston University , who was not involved in the study .
“ But in terms of mortality , you might actually be at a greater risk because there may not be the services there to support you.
” One of the biggest predictors of infection rate was metropolitan size—a factor that the researchers see as reflecting the number of metropolitan area counties that are closely linked by community , transportation , housing and economic relationships .
And the implication that this kind of connectivity among communities may play a significant role @ @ @ @ @ @ @ was strengthened in a follow-up longitudinal study .
It showed that larger metropolitan size was linked to higher infection and mortality rates over time , whereas higher population density ( without that confounding factor ) was linked to lower infection and mortality rates over the same period .
Still , experts are not writing off the potential impact of high density on infection risk .
“ It ’ s not a surprising conclusion to say that if you live in a dense urban area , it ’ s probably going to take a @ @ @ @ @ @ @ those contact rates , ” says Laura White , a biostatistician at Boston University .
But it remains difficult to disentangle density ’ s effect from other factors .
Many researchers say future studies could benefit from zeroing in on individual neighborhoods rather than hovering at the city and county level because—as New York City ’ s experience shows—even adjacent neighborhoods can have widely varying levels of infection and mortality .
“ Within each city , there are different communities , ” says David Rubin , a physician and director of the PolicyLab @ @ @ @ @ @ @ .
“ There is a granularity here that plays out at the neighborhood level.
” But there are challenges when studying a fast-moving pandemic based on static measures , such as residential density , that are only updated periodically , says Constantine Kontokosta , an urban planning researcher at N.Y.U .
Instead he and his colleagues have been using anonymized smartphone location data from millions of users in New York City to study what they describe as “ exposure density ” —a more dynamic measure of neighborhood activity levels—and the proportion of people @ @ @ @ @ @ @ areas .
They hope to expand this approach to many other cities across the U.S. “ This question of how people respond , and how people behave and change their behavior , is a really important component in the context of the overall levels of risk and transmission that may occur in a given place , ” Kontokosta says .
One of his group ’ s preliminary findings supports previous analyses showing that neighborhoods with higher proportions of minority and low-income populations are at higher risk of infection .
That observation corresponds with @ @ @ @ @ @ @ Boston University team highlighting how New York City communities with a higher percentage of “ essential workers ” —who are more likely to come from these socioeconomic groups and must commute—are at greater risk .
“ Density is likely to be just one of several key factors that determine how vulnerable city residents are to COVID-19 .
And it seemingly plays a smaller role , compared to socioeconomic factors , ” says James Sallis , a public health researcher at the University of California , San Diego .
There is a risk that @ @ @ @ @ @ @ enemy ” could encourage some local governments and developers to promote suburban sprawl for misguided reasons , Adlakha says .
She and Sallis studied a small but diverse sample of several dozen cities around the world without finding any association between high density and per capita COVID-19 cases or death rates .
Much more work needs to be done to clarify how population density and other factors shape the spread of COVID-19 .
But researchers advise that it would be premature to bemoan the “ end ” of cities or to abandon them @ @ @ @ @ @ @ .
“ It ’ s a misconception that we shouldn ’ t live in cities , ” Rubin says .
“ Many cities in the world are doing well.
” Read more about the coronavirus outbreak from Scientific American here .
And read coverage from our international network of magazines here .

In the early months of the COVID-19 pandemic, some U.S. leaders and pundits pointed to hard-hit cities such as New York, Milan and Wuhan as proof that population density was to blame for coronavirus hotspots. But simple density has not adequately predicted the disease’s course in the U.S., where the new coronavirus has spread well beyond urban areas to ravage rural communities and suburbs during the country’s long summer.
Many public health and urban planning researchers agree that the concentration of people within a certain area does not tell the whole story. They note the examples of high-density cities, including Hong Kong, Seoul and Taipei, where robust and widespread interventions (such as social distancing, mask wearing and contact tracing) successfully limited COVID-19 cases and deaths. And studies conducted amid the pandemic suggest that other factors—connections among communities, access to health care and crowding within a small area, for example—can also strongly influence how the disease spreads and how residents fare.
“Since the early days of the pandemic, there have been a number of articles speculating whether COVID-19 will spell the end of cities, [and] some articles suggested that COVID-19 was spurring an exodus from cities to suburbs as a way to escape the ... virus,” says Deepti Adlakha, an environmental health researcher at Queen’s University Belfast. “And from the beginning, these struck me as the wrong questions to ask.”
For one thing, the population density of a city or county does not capture the finer points of how people actually gather within smaller spaces, such as those on college campuses or in individual residential buildings. “Most often when people talk about density and COVID-19, they’re really talking about crowding,” says Shima Hamidi, an assistant professor of environmental health and engineering at Johns Hopkins University. Sometimes crowding occurs when people gather for events such as concerts or parties, notes Ann Forsyth, an urban planner at Harvard University. Crowding can also result from socioeconomic conditions that force many people to live in a small space or from cultural preferences for living in multigenerational households. Buses and other forms of mass transit can also get crowded, even in smaller urban areas.
Not every crowding situation leads to widespread viral transmission. But some have turned out to be superspreader events in a diverse array of settings in the U.S. These occurrences have included a suburban house party in Connecticut, a biotech conference at a Boston hotel, a Bible study session at a rural Arkansas church, and overnight summer camps in Georgia and Missouri. “The virus can spread very efficiently in crowds. It doesn't seem to always happen, but it can happen,” says Lorna Thorpe, a New York University epidemiologist.
High-density cities may offer more opportunities for crowding. But in Asia, proper public health precautions have spared many megalopolises from the worst. Even in hard-hit New York City, Manhattan has maintained the lowest COVID-19 rates among the city’s five boroughs, despite having the highest population density. Meanwhile some lower-density neighborhoods in Queens and the Bronx have seen higher rates of infection and death.
Hamidi looked at some of the confounding factors—metropolitan size, socioeconomic status of residents, quality of health care and adoption of social distancing—when analyzing how density affects COVID-19 spread and mortality in more than 900 U.S. counties. She and her collaborators at the University of Utah found that county density had no significant relationship with infection rate. In fact, higher-density counties were actually associated with lower mortality rates, possibly because residents were more strictly following social-distancing guidelines or had better access to health care. “If you want to move to a rural area to be safe from getting COVID, maybe [that helps] because you have fewer contacts,” says Brooke Nichols, a health economist at Boston University, who was not involved in the study. “But in terms of mortality, you might actually be at a greater risk because there may not be the services there to support you.”
One of the biggest predictors of infection rate was metropolitan size—a factor that the researchers see as reflecting the number of metropolitan area counties that are closely linked by community, transportation, housing and economic relationships. And the implication that this kind of connectivity among communities may play a significant role in the spread of the novel coronavirus was strengthened in a follow-up longitudinal study. It showed that larger metropolitan size was linked to higher infection and mortality rates over time, whereas higher population density (without that confounding factor) was linked to lower infection and mortality rates over the same period.
Still, experts are not writing off the potential impact of high density on infection risk. “It’s not a surprising conclusion to say that if you live in a dense urban area, it’s probably going to take a little bit more intervention to really reduce those contact rates,” says Laura White, a biostatistician at Boston University. But it remains difficult to disentangle density’s effect from other factors.
Many researchers say future studies could benefit from zeroing in on individual neighborhoods rather than hovering at the city and county level because—as New York City’s experience shows—even adjacent neighborhoods can have widely varying levels of infection and mortality. “Within each city, there are different communities,” says David Rubin, a physician and director of the PolicyLab at the Children's Hospital of Philadelphia. “There is a granularity here that plays out at the neighborhood level.”
But there are challenges when studying a fast-moving pandemic based on static measures, such as residential density, that are only updated periodically, says Constantine Kontokosta, an urban planning researcher at N.Y.U. Instead he and his colleagues have been using anonymized smartphone location data from millions of users in New York City to study what they describe as “exposure density”—a more dynamic measure of neighborhood activity levels—and the proportion of people’s activities taking place in higher-risk areas. They hope to expand this approach to many other cities across the U.S. “This question of how people respond, and how people behave and change their behavior, is a really important component in the context of the overall levels of risk and transmission that may occur in a given place,” Kontokosta says.
One of his group’s preliminary findings supports previous analyses showing that neighborhoods with higher proportions of minority and low-income populations are at higher risk of infection. That observation corresponds with a preprint paper by White’s Boston University team highlighting how New York City communities with a higher percentage of “essential workers”—who are more likely to come from these socioeconomic groups and must commute—are at greater risk. “Density is likely to be just one of several key factors that determine how vulnerable city residents are to COVID-19. And it seemingly plays a smaller role, compared to socioeconomic factors,” says James Sallis, a public health researcher at the University of California, San Diego.
There is a risk that ongoing misperceptions of density as the “enemy” could encourage some local governments and developers to promote suburban sprawl for misguided reasons, Adlakha says. She and Sallis studied a small but diverse sample of several dozen cities around the world without finding any association between high density and per capita COVID-19 cases or death rates.
Much more work needs to be done to clarify how population density and other factors shape the spread of COVID-19. But researchers advise that it would be premature to bemoan the “end” of cities or to abandon them purely out of fear of the virus. “It’s a misconception that we shouldn’t live in cities,” Rubin says. “Many cities in the world are doing well.”
Read more about the coronavirus outbreak from Scientific American here. And read coverage from our international network of magazines here.


scientificamerican--2020-09-15--We Can't Allow the CDC to Be Tainted by Politics

The CDC ’ s Mortality and Morbidity Weekly Report , familiarly known as the MMWR , has been around for nearly a century , and is sacrosanct in the public health community .
Loaded with reliable , timely data and analyses and authored by the world ’ s top scientists , it is required reading , especially during a pandemic .
To meddle with , delay or politicize these reports would be a form of scientific blasphemy as well as a breach of public trust that could undermine the nation ’ s efforts to fight the coronavirus .
If public @ @ @ @ @ @ @ tool and doubt the substance of these reports , the U.S. response to the coronavirus pandemic will have been dealt yet another setback that stands to play out with greater suffering and more deaths in communities across the country .
A report in Politico this past weekend suggests that communications officials at the Department of Health and Human Services have been pushing back on , altering and even delaying MMWR reports to better align with a political narrative about the pandemic .
E-mails cited by Politico reveal tensions and pushback between political appointees @ @ @ @ @ @ @ scientists .
As acting director of the CDC at the dawn of the H1N1 pandemic in 2009 , I felt the natural tensions that can occur between political appointees and career public health officials at CDC .
During my tenure , the science was always—without exception—the driving force in the review process and in our communications to the public .
Indeed , in the many decades I ’ ve spent in public health , including 13 years at CDC , science has been the arbiter of truth and carried the day no matter @ @ @ @ @ @ @ That must remain the case today .
The MMWR is among the most sober and least political public health communiques one can imagine .
The name itself—Mortality and Morbidity Weekly Report—could only have been conceived by scientists rather than professional communicators .
I ’ ve reviewed hundreds and co-authored several of these reports , which are notoriously meticulous , built on foundations of data and notably devoid of adjectives .
The just-the-facts approach could be frustrating , in fact , because any public health guidance that carried even a whiff of the subjective @ @ @ @ @ @ @ science-driven editors .
This is as it should be for public health communications written for the public health community , and it ’ s why the integrity of these reports has been second to none .
In 2009 , the first communications from CDC about H1N1 were included in the MMWR .
Two cases in California detailed in an MMWR in April of that year gave us an early indication that the virus first reported in Mexico had crossed into the United States .
From that point forward—much as we ’ re seeing @ @ @ @ @ @ @ tool in filling in the gaps in knowledge while informing public health officials in every state in the country , and in real time , what they might be facing .
These reports are the keepers of the latest statistics and allow for sharing of information to be used in planning and response during a public health crisis .
Because the voice of the CDC has largely been silenced during the coronavirus pandemic and unable to regularly reach the public , the MMWRs have become an even more critical conduit for the latest @ @ @ @ @ @ @ and driven by scientific rigor , they have detailed everything from COVID-19 spread at church events to outbreaks among college students to a comprehensive look at who is dying from COVID-19 in the U.S .
The latest report , issued the day the Politico story broke , detailed COVID-19 outbreaks at three Utah childcare facilities .
Each report is an important puzzle piece in helping on-the-ground public health officials better understand the virus and emerging epidemiological learnings .
Since the early weeks of this pandemic , there have been questions about political influence @ @ @ @ @ @ @ , and whether the CDC has been able to do the necessary work to inform and lead the federal government ’ s response .
But even as these debates have raged about whether to mask or not to mask and whether hydroxychloroquine was or wasn ’ t an effective treatment for COVID-19 , the MMWRs have continued to produce revelatory and relevant pandemic intelligence—scientific documents that appeared immune to the day ’ s politics .
Instead , we now see the undermining of the public ’ s trust of our key institutions at @ @ @ @ @ @ @ up that trust .
In communities of color , in particular , that have been disproportionately impacted by the coronavirus , many already don ’ t trust government ’ s role in health and in their lives .
Systemic racism has caused , and continues to cause , great harm in these communities .
We know from this pandemic ’ s short history—and from MMWRs—that Black , Latinx and Native Americans have been bearing the pandemic ’ s greatest toll .
As we head into fall and the very real possibility that a @ @ @ @ @ @ @ distribution , we can not afford any further disintegration of trust in these communities and beyond .
After all , a vaccine only matters if the public at large gets vaccinated .
The landmark of 200,000 deaths that is fast approaching reflects a scale of tragedy that the United States did not have to bear .
CDC science should not be undermined nor the voices of its experts muted , or our nation will suffer a crisis of confidence and trust that will continue to hamper our recovery from this pandemic and open @ @ @ @ @ @ @ suffering .
We can not let this happen .

The CDC’s Mortality and Morbidity Weekly Report, familiarly known as the MMWR, has been around for nearly a century, and is sacrosanct in the public health community. Loaded with reliable, timely data and analyses and authored by the world’s top scientists, it is required reading, especially during a pandemic.
To meddle with, delay or politicize these reports would be a form of scientific blasphemy as well as a breach of public trust that could undermine the nation’s efforts to fight the coronavirus. If public health officials lose confidence in this vital tool and doubt the substance of these reports, the U.S. response to the coronavirus pandemic will have been dealt yet another setback that stands to play out with greater suffering and more deaths in communities across the country.
A report in Politico this past weekend suggests that communications officials at the Department of Health and Human Services have been pushing back on, altering and even delaying MMWR reports to better align with a political narrative about the pandemic. E-mails cited by Politico reveal tensions and pushback between political appointees and Centers for Disease Control and Prevention scientists.
As acting director of the CDC at the dawn of the H1N1 pandemic in 2009, I felt the natural tensions that can occur between political appointees and career public health officials at CDC. During my tenure, the science was always—without exception—the driving force in the review process and in our communications to the public. Indeed, in the many decades I’ve spent in public health, including 13 years at CDC, science has been the arbiter of truth and carried the day no matter the administration or the political party. That must remain the case today.
The MMWR is among the most sober and least political public health communiques one can imagine. The name itself—Mortality and Morbidity Weekly Report—could only have been conceived by scientists rather than professional communicators. I’ve reviewed hundreds and co-authored several of these reports, which are notoriously meticulous, built on foundations of data and notably devoid of adjectives. The just-the-facts approach could be frustrating, in fact, because any public health guidance that carried even a whiff of the subjective would be expunged from the reports by science-driven editors. This is as it should be for public health communications written for the public health community, and it’s why the integrity of these reports has been second to none.
In 2009, the first communications from CDC about H1N1 were included in the MMWR. Two cases in California detailed in an MMWR in April of that year gave us an early indication that the virus first reported in Mexico had crossed into the United States. From that point forward—much as we’re seeing today—the MMWRs would serve as a valuable tool in filling in the gaps in knowledge while informing public health officials in every state in the country, and in real time, what they might be facing. These reports are the keepers of the latest statistics and allow for sharing of information to be used in planning and response during a public health crisis.
Because the voice of the CDC has largely been silenced during the coronavirus pandemic and unable to regularly reach the public, the MMWRs have become an even more critical conduit for the latest information and data. Produced like clockwork and driven by scientific rigor, they have detailed everything from COVID-19 spread at church events to outbreaks among college students to a comprehensive look at who is dying from COVID-19 in the U.S. The latest report, issued the day the Politico story broke, detailed COVID-19 outbreaks at three Utah childcare facilities. Each report is an important puzzle piece in helping on-the-ground public health officials better understand the virus and emerging epidemiological learnings.
Since the early weeks of this pandemic, there have been questions about political influence on the science and public health guidelines, and whether the CDC has been able to do the necessary work to inform and lead the federal government’s response. But even as these debates have raged about whether to mask or not to mask and whether hydroxychloroquine was or wasn’t an effective treatment for COVID-19, the MMWRs have continued to produce revelatory and relevant pandemic intelligence—scientific documents that appeared immune to the day’s politics.
Instead, we now see the undermining of the public’s trust of our key institutions at the very moment we should be shoring up that trust. In communities of color, in particular, that have been disproportionately impacted by the coronavirus, many already don’t trust government’s role in health and in their lives. Systemic racism has caused, and continues to cause, great harm in these communities. We know from this pandemic’s short history—and from MMWRs—that Black, Latinx and Native Americans have been bearing the pandemic’s greatest toll. As we head into fall and the very real possibility that a coronavirus vaccine will be approved for public distribution, we cannot afford any further disintegration of trust in these communities and beyond. After all, a vaccine only matters if the public at large gets vaccinated.
The landmark of 200,000 deaths that is fast approaching reflects a scale of tragedy that the United States did not have to bear. CDC science should not be undermined nor the voices of its experts muted, or our nation will suffer a crisis of confidence and trust that will continue to hamper our recovery from this pandemic and open the door for more death and more suffering.
We cannot let this happen.


scientificamerican--2020-09-15--A New Arctic Is Emerging, Thanks to Climate Change

Scientists often speak of a “ new Arctic ” to describe the region ’ s rapidly changing landscape .
Temperatures are skyrocketing , sea ice is dwindling and many experts believe the far north is quickly transforming into something unrecognizable .
This week , new research confirms that a new Arctic climate system is , indeed , emerging .
In fact , some aspects of the Arctic climate have already changed beyond anything the region has experienced in the past century .
Sea ice extent has shrunk by 31 % since the satellite record began in 1979 .
Patterns in @ @ @ @ @ @ @ bounds of anything that would have been possible just a few decades ago .
By the end of the century , if global temperatures continue to rise unchecked , other key elements of the Arctic climate—including air temperatures and precipitation patterns—could also be profoundly different from the former 20th-century “ normal.
” Study co-authors Laura Landrum and Marika Holland , researchers at the National Center for Atmospheric Research in Colorado , published their findings yesterday in the journal Nature Climate Change .
The study , they say , is among the first to @ @ @ @ @ @ @ Arctic—the point at which climate conditions fall outside even the furthest boundaries of what was previously “ normal ” —across both sea and land .
“ The changes are so rapid and so large that the Arctic [ has ] warmed so significantly that its year-to-year variability is moving outside the bounds of past fluctuations , signaling a transition to a new climate , ” Landrum told E & E News .
Landrum and Holland used large ensembles of climate models to investigate how the Arctic climate has changed over the last century @ @ @ @ @ @ @ in store over the next 100 years .
Looking into the future , they focused on a severe hypothetical climate scenario—a trajectory many scientists think of as the worst-case scenario if human societies do nothing to curb their greenhouse gas emissions .
The researchers specifically examined changes in Arctic sea ice extent , air temperatures and precipitation patterns .
Sea ice , they found , has already declined beyond the bounds of anything that would have been seen even a few decades ago .
In other words , at least one signal of @ @ @ @ @ @ @ emerged .
And sea ice declines will only get worse as time goes on .
Under the extreme climate scenario , summer sea ice extent will fall below 1 million square kilometers—a threshold so low most scientists consider the Arctic Ocean “ ice free ” at that point—by the 2070s at the latest , and potentially decades earlier .
Air temperatures are likely to cross the threshold by the middle of this century , with fall temperatures changing the fastest .
Changes in precipitation—namely , a transition from snow to rain—will represent a @ @ @ @ @ @ @ sense , considering the way different aspects of the Arctic climate system are linked .
Sea ice can have a profound effect on Arctic temperatures .
Ice has a bright , reflective surface that helps beam sunlight away from the Earth .
Thick sea ice also helps insulate the ocean , trapping heat below the surface in the winter and preventing it from escaping into the cold Arctic air .
As sea ice thins and disappears , the ocean is able to absorb more heat in the summer .
And in the winter @ @ @ @ @ @ @ through the thinner ice and warm up the atmosphere .
“ You would expect ice to play a role in warming the temperature because of these feedbacks , ” Landrum said .
The rising temperatures , in turn , help speed up the transition from snow to rain .
The findings confirm that a new Arctic is already emerging—and that if global temperatures keep rising at their current pace , the transformation to an unrecognizable climate system could be complete before the end of this century .
It ’ s a clear sign @ @ @ @ @ @ @ problem for the future—it ’ s already dramatically reshaping the planet today .
It ’ s also a huge concern for the Arctic ecosystem and the human communities that rely on it .
A new Arctic will be warmer , rainier and substantially less frozen .
Animals that used to be common may disappear , while new species may move in to take their place .
Opportunities for hunting and fishing by sea ice could dwindle .
Shipping in the Arctic Ocean may significantly increase as the ice disappears .
Meanwhile , planning @ @ @ @ @ @ @ task .
Community planners often design infrastructure , made to last a certain number of years or withstand a certain level of stress , by looking at past weather observations .
But as the Arctic climate transforms , the past is no longer a good predictor of what to expect in the future .
“ We ’ re entering a period where the previous observations we have do not and can not describe the time that we ’ re entering , ” Landrum said .
While the study provides a grim snapshot of @ @ @ @ @ @ @ not necessarily inevitable .
Other studies have indicated that a more moderate climate scenario—one in which world nations substantially reduce greenhouse gas emissions in the coming decades—could stall or prevent some of these changes .
But the research does demonstrate that immediate action is needed .
“ For those living in the Arctic—whether it ’ s human , animal , plant—climate change is not something in the future , ” Landrum said .
“ It ’ s something that ’ s happening now.
” Reprinted from Climatewire with permission from E & E @ @ @ @ @ @ @ coverage of essential energy and environmental news at www.eenews.net .

Scientists often speak of a “new Arctic” to describe the region’s rapidly changing landscape. Temperatures are skyrocketing, sea ice is dwindling and many experts believe the far north is quickly transforming into something unrecognizable.
This week, new research confirms that a new Arctic climate system is, indeed, emerging.
In fact, some aspects of the Arctic climate have already changed beyond anything the region has experienced in the past century. Sea ice extent has shrunk by 31% since the satellite record began in 1979. Patterns in ice coverage today have dropped beyond the bounds of anything that would have been possible just a few decades ago.
By the end of the century, if global temperatures continue to rise unchecked, other key elements of the Arctic climate—including air temperatures and precipitation patterns—could also be profoundly different from the former 20th-century “normal.”
Study co-authors Laura Landrum and Marika Holland, researchers at the National Center for Atmospheric Research in Colorado, published their findings yesterday in the journal Nature Climate Change. The study, they say, is among the first to examine the timing of the emerging new Arctic—the point at which climate conditions fall outside even the furthest boundaries of what was previously “normal”—across both sea and land.
“The changes are so rapid and so large that the Arctic [has] warmed so significantly that its year-to-year variability is moving outside the bounds of past fluctuations, signaling a transition to a new climate,” Landrum told E&E News.
Landrum and Holland used large ensembles of climate models to investigate how the Arctic climate has changed over the last century and what kinds of changes may be in store over the next 100 years. Looking into the future, they focused on a severe hypothetical climate scenario—a trajectory many scientists think of as the worst-case scenario if human societies do nothing to curb their greenhouse gas emissions.
The researchers specifically examined changes in Arctic sea ice extent, air temperatures and precipitation patterns.
Sea ice, they found, has already declined beyond the bounds of anything that would have been seen even a few decades ago. In other words, at least one signal of the new Arctic—driven by climate change—has already emerged.
And sea ice declines will only get worse as time goes on. Under the extreme climate scenario, summer sea ice extent will fall below 1 million square kilometers—a threshold so low most scientists consider the Arctic Ocean “ice free” at that point—by the 2070s at the latest, and potentially decades earlier.
Air temperatures are likely to cross the threshold by the middle of this century, with fall temperatures changing the fastest. Changes in precipitation—namely, a transition from snow to rain—will represent a new Arctic shortly afterward.
That makes sense, considering the way different aspects of the Arctic climate system are linked.
Sea ice can have a profound effect on Arctic temperatures. Ice has a bright, reflective surface that helps beam sunlight away from the Earth. Thick sea ice also helps insulate the ocean, trapping heat below the surface in the winter and preventing it from escaping into the cold Arctic air.
As sea ice thins and disappears, the ocean is able to absorb more heat in the summer. And in the winter, that heat is able to escape through the thinner ice and warm up the atmosphere.
“You would expect ice to play a role in warming the temperature because of these feedbacks,” Landrum said.
The rising temperatures, in turn, help speed up the transition from snow to rain.
The findings confirm that a new Arctic is already emerging—and that if global temperatures keep rising at their current pace, the transformation to an unrecognizable climate system could be complete before the end of this century.
It’s a clear sign that climate change isn’t a problem for the future—it’s already dramatically reshaping the planet today. It’s also a huge concern for the Arctic ecosystem and the human communities that rely on it.
A new Arctic will be warmer, rainier and substantially less frozen. Animals that used to be common may disappear, while new species may move in to take their place. Opportunities for hunting and fishing by sea ice could dwindle. Shipping in the Arctic Ocean may significantly increase as the ice disappears.
Meanwhile, planning for disasters may be an increasingly difficult task.
Community planners often design infrastructure, made to last a certain number of years or withstand a certain level of stress, by looking at past weather observations. But as the Arctic climate transforms, the past is no longer a good predictor of what to expect in the future.
“We’re entering a period where the previous observations we have do not and cannot describe the time that we’re entering,” Landrum said.
While the study provides a grim snapshot of a possible future, it’s not necessarily inevitable. Other studies have indicated that a more moderate climate scenario—one in which world nations substantially reduce greenhouse gas emissions in the coming decades—could stall or prevent some of these changes.
But the research does demonstrate that immediate action is needed.
“For those living in the Arctic—whether it’s human, animal, plant—climate change is not something in the future,” Landrum said. “It’s something that’s happening now.”
Reprinted from Climatewire with permission from E&E News. E&E provides daily coverage of essential energy and environmental news at www.eenews.net.


scientificamerican--2020-09-15--NIH 'Very Concerned' about Serious Side Effect in Coronavirus Vaccine Trial

The Food and Drug Administration is weighing whether to follow British regulators in resuming a coronavirus vaccine trial that was halted when a participant suffered spinal cord damage , even as the National Institutes of Health has launched an investigation of the case .
“ The highest levels of NIH are very concerned , ” said Dr. Avindra Nath , intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke , an NIH division .
“ Everyone ’ s hopes are on a vaccine , and if you have a major complication @ @ @ @ @ @ @ A great deal of uncertainty remains about what happened to the unnamed patient , to the frustration of those avidly following the progress of vaccine testing .
AstraZeneca , which is running the global trial of the vaccine it produced with Oxford University , said the trial volunteer recovered from a severe inflammation of the spinal cord and is no longer hospitalized .
AstraZeneca has not confirmed that the patient was afflicted with transverse myelitis , but Nath and another neurologist said they understood this to be the case .
Transverse myelitis produces @ @ @ @ @ @ @ the spinal cord that can cause pain , muscle weakness and paralysis .
Britain ’ s regulatory body , the Medicines and Healthcare Products Regulatory Agency , reviewed the case and has allowed the trial to resume in the United Kingdom .
AstraZeneca “ need [ s ] to be more forthcoming with a potential complication of a vaccine which will eventually be given to millions of people , ” said Nath .
“ We would like to see how we can help , but the lack of information makes it difficult to @ @ @ @ @ @ @ to continue the trial is complex because it ’ s difficult to assess the cause of a rare injury that occurs during a vaccine trial—and because scientists and authorities have to weigh the risk of uncommon side effects against a vaccine that might curb the pandemic .
“ So many factors go into these decisions , ” Nath said .
“ I ’ m sure everything is on the table .
The last thing you want to do is hurt healthy people.
” The NIH has yet to get tissue or blood samples @ @ @ @ @ @ @ investigation is “ in the planning stages , ” Nath said .
U.S. scientists could look at samples from other vaccinated patients to see whether any of the antibodies they generated in response to the coronavirus also attack brain or spinal cord tissue .
Such studies might take a month or two , he said .
The FDA declined to comment on how long it would take before it decides whether to move forward .
Dr. Jesse Goodman , a Georgetown University professor and physician who was chief scientist and lead vaccine regulator @ @ @ @ @ @ @ , said the agency will review the data and possibly consult with British regulators before allowing resumption of the U.S. study , which had just begun when the injury was reported .
Two other coronavirus vaccines are also in late-stage trials in the U.S .
If it determines the injury in the British trial was caused by the vaccine , the FDA could pause the trial .
If it allows it to resume , regulators and scientists surely will be on the watch for similar symptoms in other trial participants .
A volunteer @ @ @ @ @ @ @ trial experienced a similar side effect , but investigators discovered she had multiple sclerosis that was unrelated to the vaccination , according to Dr. Elliot Frohman , director of the Multiple Sclerosis & Neuroimmunology Center at the University of Texas .
Neurologists who study illnesses like transverse myelitis say they are rare—occurring at a rate of perhaps 1 in 250,000 people—and strike most often as a result of the body ’ s immune response to a virus .
Less frequently , such episodes have also been linked to vaccines .
The precise cause @ @ @ @ @ @ @ decision by authorities whether to resume the trial .
Sometimes an underlying medical condition is “ unmasked ” by a person ’ s immune response to the vaccine , leading to illness , as happened with the MS patient .
In that case , the trial might be continued without fear , because the illness was not specific to the vaccine .
More worrisome is a phenomenon called “ molecular mimicry.
” In such cases , some small piece of the vaccine may be similar to tissue in the brain or spinal cord @ @ @ @ @ @ @ that tissue in response to a vaccine component .
Should that be the case , another occurrence of transverse myelitis would be likely if the trial resumed , said Dr. William Schaffner , an infectious disease specialist at the Vanderbilt University School of Medicine .
A second case would shut down the trial , he said .
In 1976 , a massive swine flu vaccination program was halted when doctors began diagnosing a similar disorder , Guillain-Barré syndrome , in people who received the vaccine .
At the time no one knew how @ @ @ @ @ @ @ difficult to tell whether the episodes were related to the vaccine .
Eventually , scientists found that the vaccine increased the risk of the disorder by an additional one case among every 100,000 vaccinated patients .
Typical seasonal flu vaccination raises the risk of GBS in about one additional case in every 1 million people .
“ It ’ s very , very hard ” to determine if one rare event was caused by a vaccine , Schaffner said .
“ How do you attribute an increased risk for something that occurs in @ @ @ @ @ @ @ Before allowing U.S. trials to restart , the FDA will want to see why the company and an independent data and safety monitoring board ( DSMB ) in the U.K. felt it was safe to continue , Goodman said .
The AstraZeneca trial in the United States has a separate safety board .
FDA officials will need to review full details of the case and may request more information about the affected study volunteer before deciding whether to allow the U.S. trial to continue , Goodman said .
They may also require AstraZeneca @ @ @ @ @ @ @ to study participants .
It ’ s possible that the volunteer ’ s health problem was a coincidence unrelated to the vaccine , said Dr. Amesh Adalja , a senior scholar at the Johns Hopkins Center for Health Security .
Studies aren ’ t usually stopped over a single health problem , even if it ’ s serious .
Yet many health leaders have expressed frustration that AstraZeneca hasn ’ t released more information about the health problem that led it to halt its U.K. trial .
“ There is just so little @ @ @ @ @ @ @ impossible to understand what the diagnosis was or why the DSMB and sponsor were reassured ” that it was safe to continue , Goodman said .
AstraZeneca has said it ’ s unable to provide more information about the health problem , saying this would violate patient privacy , although it didn ’ t say how .
But there ’ s an exceptional need for transparency in a political climate rife with vaccine hesitancy and mistrust of the Trump administration ’ s handling of the COVID-19 response , leading scientists say .
“ @ @ @ @ @ @ @ patient confidentiality , I think it would be really helpful to know what their assessment of these issues was , ” Goodman said .
“ What was the diagnosis ?
If there wasn ’ t a clear diagnosis , what is it that led them to feel the trial could be restarted ?
There is so much interest and potential concern about a COVID-19 vaccine that the more information that can be provided , the more reassuring that would be.
” The FDA will need to balance any possible risks from an experimental @ @ @ @ @ @ @ , which has killed nearly 200,000 Americans .
“ There are also potential consequences if you stop a study , ” Goodman said .
If the AstraZeneca vaccine fails , the U.S. government is supporting six other COVID vaccines in the hope at least one will succeed .
The potential problems with the AstraZeneca vaccine show this to be a wise investment , Adalja said .
“ This is part of the idea of not having just one vaccine candidate going forward , ” he said .
“ It gives you a little @ @ @ @ @ @ @ to remember that vaccine research is unpredictable .
“ The investigators have inadvisedly been hyping their own vaccine , ” Schaffner said .
“ The Oxford investigators were out there this summer saying , ‘ We ’ re going to get there first.
’ But this is exactly the sort of reason … Dr. [ Anthony ] Fauci and the rest of us have been saying , ‘ You never know what will happen once you get into large-scale human trials.
’ ” This story was originally published by Kaiser Health News on @ @ @ @ @ @ @ story here .

The Food and Drug Administration is weighing whether to follow British regulators in resuming a coronavirus vaccine trial that was halted when a participant suffered spinal cord damage, even as the National Institutes of Health has launched an investigation of the case.
“The highest levels of NIH are very concerned,” said Dr. Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division. “Everyone’s hopes are on a vaccine, and if you have a major complication the whole thing could get derailed.”
A great deal of uncertainty remains about what happened to the unnamed patient, to the frustration of those avidly following the progress of vaccine testing. AstraZeneca, which is running the global trial of the vaccine it produced with Oxford University, said the trial volunteer recovered from a severe inflammation of the spinal cord and is no longer hospitalized.
AstraZeneca has not confirmed that the patient was afflicted with transverse myelitis, but Nath and another neurologist said they understood this to be the case. Transverse myelitis produces a set of symptoms involving inflammation along the spinal cord that can cause pain, muscle weakness and paralysis. Britain’s regulatory body, the Medicines and Healthcare Products Regulatory Agency, reviewed the case and has allowed the trial to resume in the United Kingdom.
AstraZeneca “need[s] to be more forthcoming with a potential complication of a vaccine which will eventually be given to millions of people,” said Nath. “We would like to see how we can help, but the lack of information makes it difficult to do so.”
Any decision about whether to continue the trial is complex because it’s difficult to assess the cause of a rare injury that occurs during a vaccine trial—and because scientists and authorities have to weigh the risk of uncommon side effects against a vaccine that might curb the pandemic.
“So many factors go into these decisions,” Nath said. “I’m sure everything is on the table. The last thing you want to do is hurt healthy people.”
The NIH has yet to get tissue or blood samples from the British patient, and its investigation is “in the planning stages,” Nath said. U.S. scientists could look at samples from other vaccinated patients to see whether any of the antibodies they generated in response to the coronavirus also attack brain or spinal cord tissue.
Such studies might take a month or two, he said. The FDA declined to comment on how long it would take before it decides whether to move forward.
Dr. Jesse Goodman, a Georgetown University professor and physician who was chief scientist and lead vaccine regulator at the FDA during the Obama administration, said the agency will review the data and possibly consult with British regulators before allowing resumption of the U.S. study, which had just begun when the injury was reported. Two other coronavirus vaccines are also in late-stage trials in the U.S.
If it determines the injury in the British trial was caused by the vaccine, the FDA could pause the trial. If it allows it to resume, regulators and scientists surely will be on the watch for similar symptoms in other trial participants.
A volunteer in an earlier phase of the AstraZeneca trial experienced a similar side effect, but investigators discovered she had multiple sclerosis that was unrelated to the vaccination, according to Dr. Elliot Frohman, director of the Multiple Sclerosis & Neuroimmunology Center at the University of Texas.
Neurologists who study illnesses like transverse myelitis say they are rare—occurring at a rate of perhaps 1 in 250,000 people—and strike most often as a result of the body’s immune response to a virus. Less frequently, such episodes have also been linked to vaccines.
The precise cause of the disease is key to the decision by authorities whether to resume the trial. Sometimes an underlying medical condition is “unmasked” by a person’s immune response to the vaccine, leading to illness, as happened with the MS patient. In that case, the trial might be continued without fear, because the illness was not specific to the vaccine.
More worrisome is a phenomenon called “molecular mimicry.” In such cases, some small piece of the vaccine may be similar to tissue in the brain or spinal cord, resulting in an immune attack on that tissue in response to a vaccine component. Should that be the case, another occurrence of transverse myelitis would be likely if the trial resumed, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine. A second case would shut down the trial, he said.
In 1976, a massive swine flu vaccination program was halted when doctors began diagnosing a similar disorder, Guillain-Barré syndrome, in people who received the vaccine. At the time no one knew how common GBS was, so it was difficult to tell whether the episodes were related to the vaccine.
Eventually, scientists found that the vaccine increased the risk of the disorder by an additional one case among every 100,000 vaccinated patients. Typical seasonal flu vaccination raises the risk of GBS in about one additional case in every 1 million people.
“It’s very, very hard” to determine if one rare event was caused by a vaccine, Schaffner said. “How do you attribute an increased risk for something that occurs in one in a million people?”
Before allowing U.S. trials to restart, the FDA will want to see why the company and an independent data and safety monitoring board (DSMB) in the U.K. felt it was safe to continue, Goodman said. The AstraZeneca trial in the United States has a separate safety board.
FDA officials will need to review full details of the case and may request more information about the affected study volunteer before deciding whether to allow the U.S. trial to continue, Goodman said. They may also require AstraZeneca to update the safety information it provides to study participants.
It’s possible that the volunteer’s health problem was a coincidence unrelated to the vaccine, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. Studies aren’t usually stopped over a single health problem, even if it’s serious.
Yet many health leaders have expressed frustration that AstraZeneca hasn’t released more information about the health problem that led it to halt its U.K. trial.
“There is just so little information about this that it’s impossible to understand what the diagnosis was or why the DSMB and sponsor were reassured” that it was safe to continue, Goodman said.
AstraZeneca has said it’s unable to provide more information about the health problem, saying this would violate patient privacy, although it didn’t say how.
But there’s an exceptional need for transparency in a political climate rife with vaccine hesitancy and mistrust of the Trump administration’s handling of the COVID-19 response, leading scientists say.
“While I respect the critical need for patient confidentiality, I think it would be really helpful to know what their assessment of these issues was,” Goodman said. “What was the diagnosis? If there wasn’t a clear diagnosis, what is it that led them to feel the trial could be restarted? There is so much interest and potential concern about a COVID-19 vaccine that the more information that can be provided, the more reassuring that would be.”
The FDA will need to balance any possible risks from an experimental vaccine with the danger posed by COVID-19, which has killed nearly 200,000 Americans.
“There are also potential consequences if you stop a study,” Goodman said.
If the AstraZeneca vaccine fails, the U.S. government is supporting six other COVID vaccines in the hope at least one will succeed. The potential problems with the AstraZeneca vaccine show this to be a wise investment, Adalja said.
“This is part of the idea of not having just one vaccine candidate going forward,” he said. “It gives you a little more insurance.”
Schaffner said researchers need to remember that vaccine research is unpredictable.
“The investigators have inadvisedly been hyping their own vaccine,” Schaffner said. “The Oxford investigators were out there this summer saying, ‘We’re going to get there first.’ But this is exactly the sort of reason … Dr. [Anthony] Fauci and the rest of us have been saying, ‘You never know what will happen once you get into large-scale human trials.’”
This story was originally published by Kaiser Health News on September 14 2020. Read the original story here.