9 ms·

Okay so I want to make something very clear here. The rule is to put it very very simply, is you can ship any drug that is approved but you have to list the sid

Okay so I want to make something very clear here. The rule is to put it very very simply, is you can ship any drug that is approved but you have to list the side effects. This drug was approved under an emergency order and this side effect was not listed. This will get paused long enough for the side effects to be updated and then used again. The arguments about “well the birth control pill has a higher risk” are using a fact that while it is true, is not relevant as that data has no relationship to the rules that have to be followed. The valid argument would be, those that issue the emergence order for use to should amend the order to acknowledge the issue but not block use immediately.

barsonme 5y ago
I don’t understand why you have to pause then restart. Just update the side effects as you go. Or pause for the affected groups.
- chrisandchris 5y ago
  I guess it‘s protocol. The same protocol that states that you need to list side-effects probably says if your side-effect list is wrong you have to re-list and get approved again. Until your approval is not done you don‘t get to sell. Otherwise you could delay your updating your side-effects listing because you know FDA will take your druf off-market (and this delay will/could cause harm to people).
- seoaeu 5y ago
  The pause is to figure out exactly which groups are affected, and to decide if/how to update guidance. They are presumably working as fast as possible on that. Don't forget that the doses aren't going to go bad, so it is just a short delay in administering them
- effie 5y ago
  Distributing the new document only would not be responsible. In this case, the new side effect kills people. Very rarely, but if you belong to some unlucky group, you're screwed. It is better to figure out which people are endangered. The recommendations and documents have to be good for everybody, not just for the good statistics.
kaczordon 5y ago
Umm maybe because the blood clot issue is being underreported because no one is looking for it? We’re essentially doing mass experimentation with gene-based vaccines on the US population, all the vaccines use either mRNA or DNA insertion. Caution here is the logical and ethical thing. Also: the side effect profile for the moderna and pfizer vaccines in the clinical trials was far WORSE than the jnj vaccine. Edit: gene-based not gene-therapy
- simple_phrases 5y ago
  Gene therapy and mRNA vaccines are two very different things.
  - kaczordon 5y ago
    True corrected it to “gene-based”, both jnj and astra use DNA encoding btw.
    - tylerhou 5y ago
      But neither have the ability to alter your DNA, so they are unlikely to be able to cause long-term symptoms though a gene-expression mechanism.
      - kaczordon 5y ago
        Right but they are still gene-based. No gene-based vaccine has ever received approval for human use, and the present coronavirus vaccines have not undergone preclinical testing as normally required by international regulations. A potential danger of DNA-based vaccines is the integration of plasmid DNA into the cell genome (1). Insertional mutagenesis occurs rarely but can become a realistic danger when the number of events is very large, i.e. as in mass vaccination of a population. (1) https://www.nature.com/articles/3302213 https://www.nature.com/articles/3302213
        tylerhou 5y ago
zests 5y ago
Whether or not this is true, that is not what the messaging is.
jdminhbg 5y ago
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 5y 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 5y 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 5y 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 5y 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 5y 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.
santiagobasulto 5y ago
But is it really a side effect? If 6 people vaccinated are hit by a car, is that included as a side effect? Are those side effects lists just a catch it all sort of exception where they throw anything there just in case? Honest question.
- bluGill 5y ago
  We will ask if the vaccine somehow cause those 6 people to be hit by a car, if we decide the vaccine caused that would be listed. (I don't see how a vaccine could cause people to be hit by a car, but I'm open to suggestions)
  - skykooler 5y ago
    could cause some sort of mental change that causes one to be drawn towards fast-moving objects?
    - pvarangot 5y ago
      That would probably be listed as drowsiness, depression, dementia or something like that. They already tell you not to drive heavy manchinery after the J&J vaccine though.
- myrandomcomment 5y ago
  The answer is yes, "as determined by the experts" that made the recommendation after looking at the data on this and also the data from what has happened in the UK/EU with the AZ vaccine which uses a very similar method. Are the experts correct here - no one knows at this exact second. It will take time and future studies to see if they made the correct call. One point that people are missing in the reported data is that this type of blood clot is not the usual kind where the normal treatment that I doctor would follow would fix it. The pause here is about getting the information out to the doctors and the public that says "Hey Public, if you get J&J and feel this way X,Y,Z with in X weeks of getting it go to the doctor. Hey Doctor, if someone comes in in X time of getting the J&J and feels this way X,Y,Z be aware that it could not be the NORMAL thing you think and look for XXX and treat it this different way to make sure you have a good outcome."
rebuilder 5y ago
It's really not clear at all that the incidence of this type of blood clots is actually higher in the vaccinated. So it seems early to call this a side-effect. I wish the health agencies were a bit more open about their thought processes. OTOH, the rate of incidence doesn't seem higher than baseline AFAIK, which seems absurd. It also seems absurd that the various health authorities around the world would all make such a big deal of if if there wasn't some elevated risk. So I don't really know what to make of it, but privately, I'm leaning towards the interpretation that the idea is to avoid backlash against the vaccines by being irrationally strict about any potential hazards.
- effie 5y ago
  > So it seems early to call this a side-effect. Yes, causation is hard to show with certainty. However, regulator have to follow rules, and those rules probably err on the side of caution. Similarly to "first, do no harm". I agree that the matter of public trust is also relevant here. In some countries large part of the population already does not want to get vaccinated. So the vaccinator is naturally motivated to prevent any PR screw-ups even at the cost of slowing down.
theptip 5y ago
> This drug was approved under an emergency order and this side effect was not listed. Sadly, this is the case. The German regulator's FAQ explicitly called this out; they are not interested in determining the path that saves the most lives, they are simply following the process that checks all of the boxes that the regulations require. In the EU this regulatory pause of AZ has likely killed thousands of people. > The valid argument would be, those that issue the emergence order for use to should amend the order to acknowledge the issue but not block use immediately. Or, more generally, in the emergency-order regime, all decisions that can demonstrate a clear 10:1 improvement in expected deaths should be taken, regardless of regulatory red tape. The FDA and other regulators have over-fitted their process for "minimize likelihood of another Thalidomide, for drugs which have a small chance of saving a life, and a very small chance of causing harm". This is defensible for testing a new statin, where we have existing safe drugs to choose from, and we're looking for incremental improvements. But it's shockingly harmful in an emergency. One thing that has become very clear is that the FDA and other regulators are structurally incapable of making even rudimentary risk-based tradeoffs in emergency situations, and we need to fix this.
- saurik 5y ago
  Why is the correct solution not to support people enough that the only reason anyone has to interact is to do "essential" work--for which the they should be paid hazard-level pay--and then do this slowly and carefully? We can offer the vaccine to people who would then feel better taking it--particularly if it means they get to make hazard-level pay--but it wouldn't matter if people didn't: the main risk of getting covid should be "I decided to interact with people, knowing the risks", and it isn't our job to prevent them from getting ill any more than it is our job to police peoples' home lives. This whole "the sky is falling" emergency scenario is a false dichotomy we have constructed to avoid actually staring at the problem of wage slavery :(.
- effie 5y ago
  > The German regulator's FAQ explicitly called this out; they are not interested in determining the path that saves the most lives, they are simply following the process that checks all of the boxes that the regulations require. A drug regulator should do its job, which is following established rules for approving and recommending new medicines. Not invent new rules, not push experimental drugs when new problems are being discovered on the go. Advocating for "greater-good" trade-offs and risks is a political effort, the regulator should be immune from political pressures. I'm glad people there prefer to err on the side of going with established rules and caution. If what you want is experimental drug being accessible to as many people as possible as soon as possible, you should advocate for the option to bypass the regulator and letting the people decide for themselves. Do not advocate for corrupting the regulator. > In the EU this regulatory pause of AZ has likely killed thousands of people. I don't know how you came to that conclusion, but even if so, how many thousands of people would be eventually harmed or killed if the pause wasn't introduced? We don't know, because we are discovering properties and effects of the vaccines on the go. The data and estimates we have are based on short-term experience with the vaccines. They will change. In treating people for illness it is a long established rule that "first, do no harm". And vaccine does not even help the patient with any illness - it is rather to help in case the patient would get one in the future. For many people, getting vaccinated has zero to negative benefit. Nobody is entitled to get a fast-tracked rubber stamp to push vaccines on people. If you want to take experimental drugs, I support your right to do so, however I expect you let other people decide for themselves, including the regulators.
softwaredoug 5y ago
It's not about the rules, it's about the optics. How many people will point to this or feel a bit hesitant about getting J&J vaccine now?

barsonme 5y ago

I don’t understand why you have to pause then restart. Just update the side effects as you go. Or pause for the affected groups.

chrisandchris 5y ago
I guess it‘s protocol. The same protocol that states that you need to list side-effects probably says if your side-effect list is wrong you have to re-list and get approved again. Until your approval is not done you don‘t get to sell. Otherwise you could delay your updating your side-effects listing because you know FDA will take your druf off-market (and this delay will/could cause harm to people).
seoaeu 5y ago
The pause is to figure out exactly which groups are affected, and to decide if/how to update guidance. They are presumably working as fast as possible on that. Don't forget that the doses aren't going to go bad, so it is just a short delay in administering them
effie 5y ago
Distributing the new document only would not be responsible. In this case, the new side effect kills people. Very rarely, but if you belong to some unlucky group, you're screwed. It is better to figure out which people are endangered. The recommendations and documents have to be good for everybody, not just for the good statistics.

kaczordon 5y ago

Umm maybe because the blood clot issue is being underreported because no one is looking for it? We’re essentially doing mass experimentation with gene-based vaccines on the US population, all the vaccines use either mRNA or DNA insertion. Caution here is the logical and ethical thing. Also: the side effect profile for the moderna and pfizer vaccines in the clinical trials was far WORSE than the jnj vaccine. Edit: gene-based not gene-therapy

simple_phrases 5y ago
Gene therapy and mRNA vaccines are two very different things.
- kaczordon 5y ago
  True corrected it to “gene-based”, both jnj and astra use DNA encoding btw.
  - tylerhou 5y ago
    But neither have the ability to alter your DNA, so they are unlikely to be able to cause long-term symptoms though a gene-expression mechanism.
    - kaczordon 5y ago
      Right but they are still gene-based. No gene-based vaccine has ever received approval for human use, and the present coronavirus vaccines have not undergone preclinical testing as normally required by international regulations. A potential danger of DNA-based vaccines is the integration of plasmid DNA into the cell genome (1). Insertional mutagenesis occurs rarely but can become a realistic danger when the number of events is very large, i.e. as in mass vaccination of a population. (1) https://www.nature.com/articles/3302213 https://www.nature.com/articles/3302213
      - tylerhou 5y ago

zests 5y ago

Whether or not this is true, that is not what the messaging is.

jdminhbg 5y ago

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 5y 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 5y 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 5y 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 5y 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 5y 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.

santiagobasulto 5y ago

But is it really a side effect? If 6 people vaccinated are hit by a car, is that included as a side effect? Are those side effects lists just a catch it all sort of exception where they throw anything there just in case? Honest question.

bluGill 5y ago
We will ask if the vaccine somehow cause those 6 people to be hit by a car, if we decide the vaccine caused that would be listed. (I don't see how a vaccine could cause people to be hit by a car, but I'm open to suggestions)
- skykooler 5y ago
  could cause some sort of mental change that causes one to be drawn towards fast-moving objects?
  - pvarangot 5y ago
    That would probably be listed as drowsiness, depression, dementia or something like that. They already tell you not to drive heavy manchinery after the J&J vaccine though.
myrandomcomment 5y ago
The answer is yes, "as determined by the experts" that made the recommendation after looking at the data on this and also the data from what has happened in the UK/EU with the AZ vaccine which uses a very similar method. Are the experts correct here - no one knows at this exact second. It will take time and future studies to see if they made the correct call. One point that people are missing in the reported data is that this type of blood clot is not the usual kind where the normal treatment that I doctor would follow would fix it. The pause here is about getting the information out to the doctors and the public that says "Hey Public, if you get J&J and feel this way X,Y,Z with in X weeks of getting it go to the doctor. Hey Doctor, if someone comes in in X time of getting the J&J and feels this way X,Y,Z be aware that it could not be the NORMAL thing you think and look for XXX and treat it this different way to make sure you have a good outcome."

rebuilder 5y ago

It's really not clear at all that the incidence of this type of blood clots is actually higher in the vaccinated. So it seems early to call this a side-effect. I wish the health agencies were a bit more open about their thought processes. OTOH, the rate of incidence doesn't seem higher than baseline AFAIK, which seems absurd. It also seems absurd that the various health authorities around the world would all make such a big deal of if if there wasn't some elevated risk. So I don't really know what to make of it, but privately, I'm leaning towards the interpretation that the idea is to avoid backlash against the vaccines by being irrationally strict about any potential hazards.

effie 5y ago
> So it seems early to call this a side-effect. Yes, causation is hard to show with certainty. However, regulator have to follow rules, and those rules probably err on the side of caution. Similarly to "first, do no harm". I agree that the matter of public trust is also relevant here. In some countries large part of the population already does not want to get vaccinated. So the vaccinator is naturally motivated to prevent any PR screw-ups even at the cost of slowing down.

theptip 5y ago

> This drug was approved under an emergency order and this side effect was not listed. Sadly, this is the case. The German regulator's FAQ explicitly called this out; they are not interested in determining the path that saves the most lives, they are simply following the process that checks all of the boxes that the regulations require. In the EU this regulatory pause of AZ has likely killed thousands of people. > The valid argument would be, those that issue the emergence order for use to should amend the order to acknowledge the issue but not block use immediately. Or, more generally, in the emergency-order regime, all decisions that can demonstrate a clear 10:1 improvement in expected deaths should be taken, regardless of regulatory red tape. The FDA and other regulators have over-fitted their process for "minimize likelihood of another Thalidomide, for drugs which have a small chance of saving a life, and a very small chance of causing harm". This is defensible for testing a new statin, where we have existing safe drugs to choose from, and we're looking for incremental improvements. But it's shockingly harmful in an emergency. One thing that has become very clear is that the FDA and other regulators are structurally incapable of making even rudimentary risk-based tradeoffs in emergency situations, and we need to fix this.

saurik 5y ago
Why is the correct solution not to support people enough that the only reason anyone has to interact is to do "essential" work--for which the they should be paid hazard-level pay--and then do this slowly and carefully? We can offer the vaccine to people who would then feel better taking it--particularly if it means they get to make hazard-level pay--but it wouldn't matter if people didn't: the main risk of getting covid should be "I decided to interact with people, knowing the risks", and it isn't our job to prevent them from getting ill any more than it is our job to police peoples' home lives. This whole "the sky is falling" emergency scenario is a false dichotomy we have constructed to avoid actually staring at the problem of wage slavery :(.
effie 5y ago
> The German regulator's FAQ explicitly called this out; they are not interested in determining the path that saves the most lives, they are simply following the process that checks all of the boxes that the regulations require. A drug regulator should do its job, which is following established rules for approving and recommending new medicines. Not invent new rules, not push experimental drugs when new problems are being discovered on the go. Advocating for "greater-good" trade-offs and risks is a political effort, the regulator should be immune from political pressures. I'm glad people there prefer to err on the side of going with established rules and caution. If what you want is experimental drug being accessible to as many people as possible as soon as possible, you should advocate for the option to bypass the regulator and letting the people decide for themselves. Do not advocate for corrupting the regulator. > In the EU this regulatory pause of AZ has likely killed thousands of people. I don't know how you came to that conclusion, but even if so, how many thousands of people would be eventually harmed or killed if the pause wasn't introduced? We don't know, because we are discovering properties and effects of the vaccines on the go. The data and estimates we have are based on short-term experience with the vaccines. They will change. In treating people for illness it is a long established rule that "first, do no harm". And vaccine does not even help the patient with any illness - it is rather to help in case the patient would get one in the future. For many people, getting vaccinated has zero to negative benefit. Nobody is entitled to get a fast-tracked rubber stamp to push vaccines on people. If you want to take experimental drugs, I support your right to do so, however I expect you let other people decide for themselves, including the regulators.

softwaredoug 5y ago

It's not about the rules, it's about the optics. How many people will point to this or feel a bit hesitant about getting J&J vaccine now?