ASA Connect

In October 2019, President Trump signed an executive requiring all regulatory guidances, including guidances from the FDA, to be submitted to administration political appointees for acceptance or rejection.

The New York Times reports that for the first time, the Trump administration has rejected a proposed FDA guidance, a guidance on developing vaccines for COVID-19. They report that the administration particularly opposes minimum follow-up guidance that would delay approval of a new vaccine until after November 3.

In the past, I hve suggested that the ASA hesitate to comment too often on administration behavior, to make sure to be clear that the concern is scientific integrity and not mere dislike of the administration or its policies, the interests of government statisticians as employees, etc.

On this one, the ASA needs to take a position. Political interference with the conduct and evaluation of clinical trials, especially for reasons of political positioning, is something we should clearly oppose. Here, the need to preserve scientific integrity is crystal clear.

This comment is my own only and not that of my employer.

White House Blocks New Coronavirus Vaccine Guidelines

Well said: both the general rule to avoid comment on administration actions where possible, and why it is necessary in this particular case, are clear. Studying the trends in the COVID-19 pandemic, we see three distinct wave starting in the US. The first wave and also the one recently begun followed the pattern seen in other countries: the long predicted Fall Wave in the Northern Hemisphere, with colder weather, the flu season etc. has begun. These are driven by intrinsic factors consistent across many nations independent of policy.   

(NB: I am NOT an by clusters epidemiologist! My comments are from the perspective of statistics only - specifically, time series analysis cluster analysis: when standard clustering methods are applied to a time series, the resulting clusters are intervals with characteristic behaviors within clusters distinct from other intervals. It's something I am able to comment on, and may be applied to this problem of distinguishing waves of a pandemic.) 

An additional wave was seen in the US, starting around July 1st. This was not observed in other countries - in fact, it was only seen in certain parts of the US. Several areas (e.g., the states of Illinois and New York) did not experience this wave at all but rather followed the pattern seen in other countries. Some states did experience this summer wave - Texas and Florida as examples. The virus does not know political boundaries: only policies change at borders. The additional wave beginning in early July was seen only in areas closely aligned with US federal administration policy. Distinct from the First and Fall waves seen in all countries, this US wave was driven by behavioral factors such as anti-mask protests and other actions disregarding safety precautions. 

The point of this is the statistics show we have already seen an increase in morbidity and mortality resulting from administration policy. We should not allow further anti-science policies to go unnoticed and without reproof. The case Dr. Siegel raised is especially critical: revoking scientific policy for political purposes has already proven deadly in several US states, and must not be allowed to set a precedent for any political party in the future. 

In October 2019, President Trump signed an executive requiring all regulatory guidances, including guidances from the FDA, to be submitted to administration political appointees for acceptance or rejection.

The New York Times reports that for the first time, the Trump administration has rejected a proposed FDA guidance, a guidance on developing vaccines for COVID-19. They report that the administration particularly opposes minimum follow-up guidance that would delay approval of a new vaccine until after November 3.

In the past, I hve suggested that the ASA hesitate to comment too often on administration behavior, to make sure to be clear that the concern is scientific integrity and not mere dislike of the administration or its policies, the interests of government statisticians as employees, etc.

On this one, the ASA needs to take a position. Political interference with the conduct and evaluation of clinical trials, especially for reasons of political positioning, is something we should clearly oppose. Here, the need to preserve scientific integrity is crystal clear.

This comment is my own only and not that of my employer.

White House Blocks New Coronavirus Vaccine Guidelines

The point of this is the statistics show we have already seen an increase in morbidity and mortality resulting from administration policy. We should not allow further anti-science policies to go unnoticed and without reproof. The case Dr. Siegel raised is especially critical: revoking scientific policy for political purposes has already proven deadly in several US states, and must not be allowed to set a precedent for any political party in the future. 

Well said: both the general rule to avoid comment on administration actions where possible, and why it is necessary in this particular case, are clear. Studying the trends in the COVID-19 pandemic, we see three distinct wave starting in the US. The first wave and also the one recently begun followed the pattern seen in other countries: the long predicted Fall Wave in the Northern Hemisphere, with colder weather, the flu season etc. has begun. These are driven by intrinsic factors consistent across many nations independent of policy.   

(NB: I am NOT an by clusters epidemiologist! My comments are from the perspective of statistics only - specifically, time series analysis cluster analysis: when standard clustering methods are applied to a time series, the resulting clusters are intervals with characteristic behaviors within clusters distinct from other intervals. It's something I am able to comment on, and may be applied to this problem of distinguishing waves of a pandemic.) 

An additional wave was seen in the US, starting around July 1st. This was not observed in other countries - in fact, it was only seen in certain parts of the US. Several areas (e.g., the states of Illinois and New York) did not experience this wave at all but rather followed the pattern seen in other countries. Some states did experience this summer wave - Texas and Florida as examples. The virus does not know political boundaries: only policies change at borders. The additional wave beginning in early July was seen only in areas closely aligned with US federal administration policy. Distinct from the First and Fall waves seen in all countries, this US wave was driven by behavioral factors such as anti-mask protests and other actions disregarding safety precautions. 

The point of this is the statistics show we have already seen an increase in morbidity and mortality resulting from administration policy. We should not allow further anti-science policies to go unnoticed and without reproof. The case Dr. Siegel raised is especially critical: revoking scientific policy for political purposes has already proven deadly in several US states, and must not be allowed to set a precedent for any political party in the future. 

In October 2019, President Trump signed an executive requiring all regulatory guidances, including guidances from the FDA, to be submitted to administration political appointees for acceptance or rejection.

The New York Times reports that for the first time, the Trump administration has rejected a proposed FDA guidance, a guidance on developing vaccines for COVID-19. They report that the administration particularly opposes minimum follow-up guidance that would delay approval of a new vaccine until after November 3.

In the past, I hve suggested that the ASA hesitate to comment too often on administration behavior, to make sure to be clear that the concern is scientific integrity and not mere dislike of the administration or its policies, the interests of government statisticians as employees, etc.

On this one, the ASA needs to take a position. Political interference with the conduct and evaluation of clinical trials, especially for reasons of political positioning, is something we should clearly oppose. Here, the need to preserve scientific integrity is crystal clear.

This comment is my own only and not that of my employer.

White House Blocks New Coronavirus Vaccine Guidelines

Well said: both the general rule to avoid comment on administration actions where possible, and why it is necessary in this particular case, are clear. Studying the trends in the COVID-19 pandemic, we see three distinct wave starting in the US. The first wave and also the one recently begun followed the pattern seen in other countries: the long predicted Fall Wave in the Northern Hemisphere, with colder weather, the flu season etc. has begun. These are driven by intrinsic factors consistent across many nations independent of policy.   

(NB: I am NOT an by clusters epidemiologist! My comments are from the perspective of statistics only - specifically, time series analysis cluster analysis: when standard clustering methods are applied to a time series, the resulting clusters are intervals with characteristic behaviors within clusters distinct from other intervals. It's something I am able to comment on, and may be applied to this problem of distinguishing waves of a pandemic.) 

An additional wave was seen in the US, starting around July 1st. This was not observed in other countries - in fact, it was only seen in certain parts of the US. Several areas (e.g., the states of Illinois and New York) did not experience this wave at all but rather followed the pattern seen in other countries. Some states did experience this summer wave - Texas and Florida as examples. The virus does not know political boundaries: only policies change at borders. The additional wave beginning in early July was seen only in areas closely aligned with US federal administration policy. Distinct from the First and Fall waves seen in all countries, this US wave was driven by behavioral factors such as anti-mask protests and other actions disregarding safety precautions. 

The point of this is the statistics show we have already seen an increase in morbidity and mortality resulting from administration policy. We should not allow further anti-science policies to go unnoticed and without reproof. The case Dr. Siegel raised is especially critical: revoking scientific policy for political purposes has already proven deadly in several US states, and must not be allowed to set a precedent for any political party in the future. 

In October 2019, President Trump signed an executive requiring all regulatory guidances, including guidances from the FDA, to be submitted to administration political appointees for acceptance or rejection.

The New York Times reports that for the first time, the Trump administration has rejected a proposed FDA guidance, a guidance on developing vaccines for COVID-19. They report that the administration particularly opposes minimum follow-up guidance that would delay approval of a new vaccine until after November 3.

In the past, I hve suggested that the ASA hesitate to comment too often on administration behavior, to make sure to be clear that the concern is scientific integrity and not mere dislike of the administration or its policies, the interests of government statisticians as employees, etc.

On this one, the ASA needs to take a position. Political interference with the conduct and evaluation of clinical trials, especially for reasons of political positioning, is something we should clearly oppose. Here, the need to preserve scientific integrity is crystal clear.

This comment is my own only and not that of my employer.

White House Blocks New Coronavirus Vaccine Guidelines

Well said: both the general rule to avoid comment on administration actions where possible, and why it is necessary in this particular case, are clear. Studying the trends in the COVID-19 pandemic, we see three distinct wave starting in the US. The first wave and also the one recently begun followed the pattern seen in other countries: the long predicted Fall Wave in the Northern Hemisphere, with colder weather, the flu season etc. has begun. These are driven by intrinsic factors consistent across many nations independent of policy.   

(NB: I am NOT an by clusters epidemiologist! My comments are from the perspective of statistics only - specifically, time series analysis cluster analysis: when standard clustering methods are applied to a time series, the resulting clusters are intervals with characteristic behaviors within clusters distinct from other intervals. It's something I am able to comment on, and may be applied to this problem of distinguishing waves of a pandemic.) 

An additional wave was seen in the US, starting around July 1st. This was not observed in other countries - in fact, it was only seen in certain parts of the US. Several areas (e.g., the states of Illinois and New York) did not experience this wave at all but rather followed the pattern seen in other countries. Some states did experience this summer wave - Texas and Florida as examples. The virus does not know political boundaries: only policies change at borders. The additional wave beginning in early July was seen only in areas closely aligned with US federal administration policy. Distinct from the First and Fall waves seen in all countries, this US wave was driven by behavioral factors such as anti-mask protests and other actions disregarding safety precautions. 

The point of this is the statistics show we have already seen an increase in morbidity and mortality resulting from administration policy. We should not allow further anti-science policies to go unnoticed and without reproof. The case Dr. Siegel raised is especially critical: revoking scientific policy for political purposes has already proven deadly in several US states, and must not be allowed to set a precedent for any political party in the future. 

In October 2019, President Trump signed an executive requiring all regulatory guidances, including guidances from the FDA, to be submitted to administration political appointees for acceptance or rejection.

The New York Times reports that for the first time, the Trump administration has rejected a proposed FDA guidance, a guidance on developing vaccines for COVID-19. They report that the administration particularly opposes minimum follow-up guidance that would delay approval of a new vaccine until after November 3.

In the past, I hve suggested that the ASA hesitate to comment too often on administration behavior, to make sure to be clear that the concern is scientific integrity and not mere dislike of the administration or its policies, the interests of government statisticians as employees, etc.

On this one, the ASA needs to take a position. Political interference with the conduct and evaluation of clinical trials, especially for reasons of political positioning, is something we should clearly oppose. Here, the need to preserve scientific integrity is crystal clear.

This comment is my own only and not that of my employer.

White House Blocks New Coronavirus Vaccine Guidelines

Let me as the group - this week, we have seen action from the New England Journal of Medicine. This action defended science and the use of science-based outcomes without mentioning any office holder, or candidate, or party. The concerns are real and focused on scientific issues. This may be, in part, a guide for what the ASA might do. Certainly we can encourage people to vote science - we have done so for some time, and the ASA's Science Policy and Advocacy organization does an excellent job.

Today, statistical science is literally under attack. Yesterday, it was announced that state and federal law enforcement stopped two separate attempts at armed insurrection against a state government for following the very science we see discussed here (disclosure: I am a Michigan resident). 

At this time, more needs to be done in defense of science, and it is our job - indeed, our duty! - to take appropriate action. The endorsement from the New England Journal of Medicine may provide some insight as to one action that could be taken. 

What to people think? 

Well said: both the general rule to avoid comment on administration actions where possible, and why it is necessary in this particular case, are clear. Studying the trends in the COVID-19 pandemic, we see three distinct wave starting in the US. The first wave and also the one recently begun followed the pattern seen in other countries: the long predicted Fall Wave in the Northern Hemisphere, with colder weather, the flu season etc. has begun. These are driven by intrinsic factors consistent across many nations independent of policy.   

(NB: I am NOT an by clusters epidemiologist! My comments are from the perspective of statistics only - specifically, time series analysis cluster analysis: when standard clustering methods are applied to a time series, the resulting clusters are intervals with characteristic behaviors within clusters distinct from other intervals. It's something I am able to comment on, and may be applied to this problem of distinguishing waves of a pandemic.) 

An additional wave was seen in the US, starting around July 1st. This was not observed in other countries - in fact, it was only seen in certain parts of the US. Several areas (e.g., the states of Illinois and New York) did not experience this wave at all but rather followed the pattern seen in other countries. Some states did experience this summer wave - Texas and Florida as examples. The virus does not know political boundaries: only policies change at borders. The additional wave beginning in early July was seen only in areas closely aligned with US federal administration policy. Distinct from the First and Fall waves seen in all countries, this US wave was driven by behavioral factors such as anti-mask protests and other actions disregarding safety precautions. 

The point of this is the statistics show we have already seen an increase in morbidity and mortality resulting from administration policy. We should not allow further anti-science policies to go unnoticed and without reproof. The case Dr. Siegel raised is especially critical: revoking scientific policy for political purposes has already proven deadly in several US states, and must not be allowed to set a precedent for any political party in the future. 

In October 2019, President Trump signed an executive requiring all regulatory guidances, including guidances from the FDA, to be submitted to administration political appointees for acceptance or rejection.

The New York Times reports that for the first time, the Trump administration has rejected a proposed FDA guidance, a guidance on developing vaccines for COVID-19. They report that the administration particularly opposes minimum follow-up guidance that would delay approval of a new vaccine until after November 3.

In the past, I hve suggested that the ASA hesitate to comment too often on administration behavior, to make sure to be clear that the concern is scientific integrity and not mere dislike of the administration or its policies, the interests of government statisticians as employees, etc.

On this one, the ASA needs to take a position. Political interference with the conduct and evaluation of clinical trials, especially for reasons of political positioning, is something we should clearly oppose. Here, the need to preserve scientific integrity is crystal clear.

This comment is my own only and not that of my employer.

White House Blocks New Coronavirus Vaccine Guidelines