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This is a vaccine for a disease that has killed over half a million people in the US over the past year, not a new breast implant. The rules are not some holy

This is a vaccine for a disease that has killed over half a million people in the US over the past year, not a new breast implant. The rules are not some holy writ handed down from above, they are our way of trying to properly manage risk. When the situation changes, the rules can also change.

peytn 6y ago
The rules do not exist to manage risk. They exist to strike a balance between ethics and risk in emergency situations. If you’d like to change them going forward, feel free to advocate. I think it’s best we stick with our current rules this round.
- jdminhbg 6y ago
  We've changed the rules for every single part of life and society because of this massive emergency, with no idea what the long-term consequences of doing so might be. I'm not sure why the FDA should be excluded.
  - peytn 6y ago
    The FDA has a process in place as per the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013. If you find that legislation inadequate in some way, I think following due process to change it is the way to go. If how we handle pandemics should be more agile, let’s get legislation behind that. I don’t think jerking our knees over an ethics safeguard that led to a pause in administration of a vaccine that soon won’t be widely available anyway is a great habit to get into.
    - jdminhbg 6y ago
      It's pretty hard to take this seriously given the total lack of legislative participation in business closure, school closure, mask mandates, etc.
  - effie 6y ago
    The change in life is supposedly temporary restriction of freedoms for emergency reasons. Maybe it is wrong but governments have that power and people accept it. Imposing political pressure on experts and forcing them to approve against their judgment would be a horrible corruption of these regulator institutions. Maybe the expert regulator think that the bar should be lowered. But then they should come forward. This should not be ordered by politicians or their handlers.
- __s 6y ago
  Our current rules are what was done. You're the one advocating for more cautious rules because you consider 1 in a million side effects too great a cost compared to the cost of non vaccinated covid
  - peytn 6y ago
    I don’t understand your comment. I’m not advocating for more cautious rules. I’m advocating for due process. The rules should be what we feel is necessary.
cogman10 6y ago
This is what's been frustrating for me with world health organizations. I get the need to make sure medicine is safe and effective, and we absolutely should follow those to a T when it comes to new medicines on the market in non-emergency situations. However, that's not the case here. vaccines are well studied in general and J&J is one of the more "normally developed" vaccines on the market. After generally ensuring that it's safe (Phase I/II tests), there should have been a damn good reason to pull it even temporarily. The "we are seeing a small increase in blood clots" really doesn't seem like a valid reason to pull a vaccine. Personally, I lay the blame primarily on anti-vaxxers. They've made us far too cautious around vaccinations. It has screwed up our risk management rules. I've no doubt that this pull back will result in anti-vaxxers publishing BS about the safety of J&J vaccinations to try and scare people away from it.
- woofie11 6y ago
  Here, risk management should be a personal decision. In this case, the right set of actions might be to grant people freedom, and let market forces rule. I think some people would choose the J&J vaccine if it meant getting vaccinated faster. Some people would choose Moderna / Pfizer, later. It really depends on things like whether or not you can work from home, how depressing it is not interacting with people, or how concerned you are about the risk of long COVID19. That's not something we can answer for anyone centrally. From a public health perspective, vaccinating people now with Johnson is an obvious win.
  - 13415 6y ago
    > risk management should be a personal decision I think this is unrealistic for medical application, not only for vaccinations but in general for anything related to side effects of drugs. First of all, most people don't have the data and in this case part of the risk management is to get more data or consolidate and evaluate existing data more thoroughly. Second, while you might be an exception, the vast majority of people do not have the knowledge and skills to properly assess risks or perform multiattribute cost-benefit analyses. Layman cannot even compare small probabilities correctly and frequently mix up risks that differ from each other by multiple orders of magnitude. Even people with fairly good knowledge of probability theory will have a hard time judging small risks without extensive comparison data and maybe some didactic tools like "micromort" comparisons.
BurningFrog 6y ago
This is the problem with the FDA system. If thousands are dying for lack of a drug or not has, at best, very little impact on the decisions. The job of the FDA is to enforce regulations, not to save lives.
whymauri 6y ago
>The rules are not some holy writ handed down from above I'm sorry, but when dealing with healthcare organizations and policy-makers, it's more like the "holy writ" than the idealized system you describe later.
MuffinFlavored 6y ago
> This is a vaccine for a disease that has killed over half a million people in the US over the past year Serious question, how many of those people would have died in the past 12 months if they didn't get COVID? The number is most likely not 500,000, but it also probably isn't 0. Is it most likely something insignificant like 5,000?
- galangalalgol 6y ago
  Initially the cdc data pointed to about 2/3rds would have died anyway in the same time period in the US, but that was a few months in. Now if you pull total deaths from the cdc, subtract deaths tagged as covid and fit a sinusoid with a 52 week period and a slope for population growth you get a pretty solid fit with the exception of the 2018 and 2015 flu, and last summer. But last summer the sinusoid is under the total daeths minus covid deaths. Integrating the area between I think we undereported covid deaths by about 50k over the summer. We are back down to predictded deaths now without counting covid deaths. So I think all half million deaths are in excess of expected value, plus another 50k.
- ghaff 6y ago
  Probably not that low. This study [1] says about 80,000. (There were about 420,000 excess deaths in the US last year.) That number isn't perfect in that it ignores any death reductions from accidents, say, that didn't happen because people were staying home. It also doesn't account for any deaths resulting from untreated conditions. [1] https://www.medrxiv.org/content/10.1101/2021.01.27.21250604v1.full https://www.medrxiv.org/content/10.1101/2021.01.27.21250604v...
- deleted 6y ago
  [deleted]
- javagram 6y ago
  > Serious question, how many of those people would have died in the past 12 months if they didn't get COVID? The number is most likely not 500,000, but it also probably isn't 0. This can be answered using “excess mortality” data. Studies have shown during that time period, about 600,000 more people died than would have been expected compared to deaths in the previous year. The official covid death count is likely an undercount of deaths caused by covid, because a number of people died from covid related complications and got recorded as pneumonia, Alzheimer’s, or heart disease/attack/stroke related deaths. https://www.nytimes.com/interactive/2021/01/14/us/covid-19-death-toll.html https://www.nytimes.com/interactive/2021/01/14/us/covid-19-d...

peytn 6y ago

The rules do not exist to manage risk. They exist to strike a balance between ethics and risk in emergency situations. If you’d like to change them going forward, feel free to advocate. I think it’s best we stick with our current rules this round.

jdminhbg 6y ago
We've changed the rules for every single part of life and society because of this massive emergency, with no idea what the long-term consequences of doing so might be. I'm not sure why the FDA should be excluded.
- peytn 6y ago
  The FDA has a process in place as per the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013. If you find that legislation inadequate in some way, I think following due process to change it is the way to go. If how we handle pandemics should be more agile, let’s get legislation behind that. I don’t think jerking our knees over an ethics safeguard that led to a pause in administration of a vaccine that soon won’t be widely available anyway is a great habit to get into.
  - jdminhbg 6y ago
    It's pretty hard to take this seriously given the total lack of legislative participation in business closure, school closure, mask mandates, etc.
- effie 6y ago
  The change in life is supposedly temporary restriction of freedoms for emergency reasons. Maybe it is wrong but governments have that power and people accept it. Imposing political pressure on experts and forcing them to approve against their judgment would be a horrible corruption of these regulator institutions. Maybe the expert regulator think that the bar should be lowered. But then they should come forward. This should not be ordered by politicians or their handlers.
__s 6y ago
Our current rules are what was done. You're the one advocating for more cautious rules because you consider 1 in a million side effects too great a cost compared to the cost of non vaccinated covid
- peytn 6y ago
  I don’t understand your comment. I’m not advocating for more cautious rules. I’m advocating for due process. The rules should be what we feel is necessary.

cogman10 6y ago

This is what's been frustrating for me with world health organizations. I get the need to make sure medicine is safe and effective, and we absolutely should follow those to a T when it comes to new medicines on the market in non-emergency situations. However, that's not the case here. vaccines are well studied in general and J&J is one of the more "normally developed" vaccines on the market. After generally ensuring that it's safe (Phase I/II tests), there should have been a damn good reason to pull it even temporarily. The "we are seeing a small increase in blood clots" really doesn't seem like a valid reason to pull a vaccine. Personally, I lay the blame primarily on anti-vaxxers. They've made us far too cautious around vaccinations. It has screwed up our risk management rules. I've no doubt that this pull back will result in anti-vaxxers publishing BS about the safety of J&J vaccinations to try and scare people away from it.

woofie11 6y ago
Here, risk management should be a personal decision. In this case, the right set of actions might be to grant people freedom, and let market forces rule. I think some people would choose the J&J vaccine if it meant getting vaccinated faster. Some people would choose Moderna / Pfizer, later. It really depends on things like whether or not you can work from home, how depressing it is not interacting with people, or how concerned you are about the risk of long COVID19. That's not something we can answer for anyone centrally. From a public health perspective, vaccinating people now with Johnson is an obvious win.
- 13415 6y ago
  > risk management should be a personal decision I think this is unrealistic for medical application, not only for vaccinations but in general for anything related to side effects of drugs. First of all, most people don't have the data and in this case part of the risk management is to get more data or consolidate and evaluate existing data more thoroughly. Second, while you might be an exception, the vast majority of people do not have the knowledge and skills to properly assess risks or perform multiattribute cost-benefit analyses. Layman cannot even compare small probabilities correctly and frequently mix up risks that differ from each other by multiple orders of magnitude. Even people with fairly good knowledge of probability theory will have a hard time judging small risks without extensive comparison data and maybe some didactic tools like "micromort" comparisons.

BurningFrog 6y ago

This is the problem with the FDA system. If thousands are dying for lack of a drug or not has, at best, very little impact on the decisions. The job of the FDA is to enforce regulations, not to save lives.

whymauri 6y ago

>The rules are not some holy writ handed down from above I'm sorry, but when dealing with healthcare organizations and policy-makers, it's more like the "holy writ" than the idealized system you describe later.

MuffinFlavored 6y ago

> This is a vaccine for a disease that has killed over half a million people in the US over the past year Serious question, how many of those people would have died in the past 12 months if they didn't get COVID? The number is most likely not 500,000, but it also probably isn't 0. Is it most likely something insignificant like 5,000?

galangalalgol 6y ago
Initially the cdc data pointed to about 2/3rds would have died anyway in the same time period in the US, but that was a few months in. Now if you pull total deaths from the cdc, subtract deaths tagged as covid and fit a sinusoid with a 52 week period and a slope for population growth you get a pretty solid fit with the exception of the 2018 and 2015 flu, and last summer. But last summer the sinusoid is under the total daeths minus covid deaths. Integrating the area between I think we undereported covid deaths by about 50k over the summer. We are back down to predictded deaths now without counting covid deaths. So I think all half million deaths are in excess of expected value, plus another 50k.
ghaff 6y ago
Probably not that low. This study [1] says about 80,000. (There were about 420,000 excess deaths in the US last year.) That number isn't perfect in that it ignores any death reductions from accidents, say, that didn't happen because people were staying home. It also doesn't account for any deaths resulting from untreated conditions. [1] https://www.medrxiv.org/content/10.1101/2021.01.27.21250604v1.full https://www.medrxiv.org/content/10.1101/2021.01.27.21250604v...
deleted 6y ago
[deleted]
javagram 6y ago
> Serious question, how many of those people would have died in the past 12 months if they didn't get COVID? The number is most likely not 500,000, but it also probably isn't 0. This can be answered using “excess mortality” data. Studies have shown during that time period, about 600,000 more people died than would have been expected compared to deaths in the previous year. The official covid death count is likely an undercount of deaths caused by covid, because a number of people died from covid related complications and got recorded as pneumonia, Alzheimer’s, or heart disease/attack/stroke related deaths. https://www.nytimes.com/interactive/2021/01/14/us/covid-19-death-toll.html https://www.nytimes.com/interactive/2021/01/14/us/covid-19-d...