7 ms·

You should trust the system and the process. No, AZ does not cause blood clots. It's being investigated for it. And even if it does cause, you should take into

by atleta 6y ago

You should trust the system and the process. No, AZ does not cause blood clots. It's being investigated for it. And even if it does cause, you should take into account the probability. Which seems to be extremely low compared to your chances of succumbing to covid. (Of course, the latter is a function of a lot of things, but if someone makes a claim that "AZ cuases bloog clots", I'm not sure if they ever looked into estimating and then comparing the said probabilities.)

jMyles 6y ago
> You should trust the system and the process. I don't know which system and process you mean specifically, but I don't think that the system of approval under the FDA in the United States generally deserves our admiration or support. The current opioid crisis is a great case study in the tragedy of trust, profit, and death. As a scientifically literate society, we can do much better.
- atleta 6y ago
  I mean the scientific system and the vaccine/medication authorization process in general in the western world. (I don't know about the other parts, so can't comment.) Yes, I completely beleive that process of the FDA and/or the EMA can be improved and if so, it should. Still: - your best bet is trusting the current system as of now - improving the system is part of the system. That's what's hard for e.g. science denialists to understand. (Don't get me wrong, I'm not hinting you are one of them, just came to mind.)
  - jMyles 6y ago
    > I mean the scientific system I have great confidence in the scientific method, precisely because it doesn't ask for my trust. The "scientific system" seems to be largely designed to obfuscate the implementation of that method. I can't help but notice that, even amidst social pressure for people to use these vaccines, the underlying data used to produce the reports remains unavailable, and will remain unavailable until the conclusion of the monitoring of phase III of the trials. I'm not sure I understand the reasons for that, and I'm quite sure that this is the first time in my life that mainstream scientists and medical journal editors have expressed such consternation about a vaccine approval process. > and the vaccine/medication authorization process in general in the western world I think it's not unfair to say that this process has failed and is no longer relevant in an internet-connected society. Countless cases demonstrate this, such as the capricious and scientifically unsound reject of cannabis happening contemporaneously with the approval of opioid preparations touted as non-habit forming, when even a single dose (of the drug and of common sense) easily refutes that claim. > - your best bet is trusting the current system as of now Why? When I can do my own research, access experts fairly directly, and make my own health care decisions? > - improving the system is part of the system. That's what's hard for e.g. science denialists to understand. (Don't get me wrong, I'm not hinting you are one of them, just came to mind.) I think everyone is interested in improvement. The question is which parts of "the system" have shown promise worth keeping. It seems to me that involvement of the state as a gatekeeper will necessarily result in this system being used for regulatory capture and profiteering first, and public health second or worse.
    - atleta 6y ago
      > I have great confidence in the scientific method, precisely because it doesn't ask for my trust. > The "scientific system" seems to be largely designed to obfuscate the implementation of that method. You are just playing around the specific words I've used. No one asked for your trust. I just said whoever is unsure about what to do, their best chance at the moment is trusting the system that is based on science (the scientific method). And also transparency. (Well, actually at any given moment. Besides working on trying to improve it.) Yes, there will always be inefficiencies and politics, etc. But even with that, your best bet is that. Because the alternatives are worse. > the underlying data used to produce the reports remains unavailable, and will remain unavailable Is this unusual? I don't know, just asking. What I know is that the Russian one, that we have bought a few millions here, doesn't have an EMA certificate yet but they have published their results in The Lancet. Now you can say that's still not the raw source data, and I agree, though scientists say that it's very unlikely to be falsified (and they are under the EMA process now anyway). > first time in my life that mainstream scientists and medical journal editors have expressed such consternation about a vaccine approval process. Who and where? Not trying to downplay it, but since it is happening under pressure (from the pandemic) since it is thus unusual it's unsurprising that there will be public criticism from inside the community as well. Under normal conditions, if they were about to change the process e.g. in preparation for something like this, it would be just a simple scientific/professional debate that we wouldn't hear about. > Why? When I can do my own research, access experts fairly directly, and make my own health care decisions? You can make your own decisions, of course. Everybody can. But you can't do your own research. I mean you can, but it's naive to think it will not be significantly worse than what's being done by the scientific community. You are alone, they are many (thousands, tens of thousands). You have basically no idea or very little idea, they have spent their life learning about one or two of the sub-fields that provide knowledge for vaccine development and safety testing. And, of course, these guys are doing it full time now, while you'll just invest a couple of hours (days, maybe weeks in the best case). I see a lot of smart people fall into this trap. There is a big difference in trying to understand the scientific results, the state of the art for the sake of understanding and between trying to somehow at some (arbitrary) level 're-evaluate' or 'check' the results and draw a contradicting conclusion. Verify whether all those science guys were right. You can't do that. I'd say that your chances are pretty slim, but I think in practice they are close to 0. Because you don't know what you don't know. You don't know what you are missing out. What you can do is try to make good decisions by trying to evaluate the the risks and the costs of the outcomes. E.g. you can say that getting a blood clot seems to be 1:167 000 from a vaccine (from the AZ one, but let's use that as an estimate for the others). You can get the numbers for the adverse outcomes for a COVID infection AND you can estimate your chance of actually contracting it. (Because the if you compare with the assumption that you get infected with a high chance then it's a no brainer.) Then you can adjust your behaviour, if it seems doable. E.g. you may be able to say that "OK, I'm waiting another year with the vaccine, because I'm not meeting anyone and not going to any closed public place, so my chances of contracting is really 0". That makes sense.
donovanian 6y ago
> You should trust the system and the process. If I'm supposed to be ok with small risks, why aren't any of the pharmaceuticals ok with the small risk that they've made a mistake and should be held liable? Why did they seek indemnity if there's no chance the vaccine could risk my health? I don't oppose the vaccine but this has never sat right with me.
- chki 6y ago
  This is not completely correct, at least in the EU there have not been any emergency vaccine authorisations by the EMA which means that pharmaceutical companies will be liable for mistakes that cause adverse health effects. In the UK there was an emergency authorisation which means that they will not be liable to the same degree. As for why they do this: There is always a small chance that the vaccine will cause adverse health effects because pharmaceutical stuff is very complex. Minimizing legal risks is a completely normal thing in all industries and part of the negotiation process. I would not draw the conclusion that they aren't 100% convinced of their vaccine but instead that their team of highly paid lawyers told them what was a good business decision.
  - donovanian 6y ago
    You're being pretty generous, and I think it sounds reasonable but placed within the broader picture (and given how liberals generally consider profit-driven healthcare systems and industry in other circumstances...) it seems like people are looking to paper over some dastardly stuff and dismiss legitimate concerns so as to not "rock the boat." For instance: > Officials from Argentina and the other Latin American country, which cannot be named as it has signed a confidentiality agreement with Pfizer, said the company’s negotiators demanded more than the usual indemnity against civil claims filed by citizens who suffer serious adverse events after being inoculated. They said Pfizer also insisted the governments cover the potential costs of civil cases brought as a result of Pfizer’s own acts of negligence, fraud, or malice. In Argentina and Brazil, Pfizer asked for sovereign assets to be put up as collateral for any future legal costs. https://www.statnews.com/2021/02/23/pfizer-plays-hardball-in-covid19-vaccine-negotiations-in-latin-america/ https://www.statnews.com/2021/02/23/pfizer-plays-hardball-in... It'd be one thing if they were looking to defend against unforeseen damages. But this looks like they're trying to evade liability for crimes.
toshk 6y ago
It's not hard to imagine that rushed trials, rushed production and pressured approvals might not lead to the best process. Next to that: Over the last 50-60 years approved medicines with the backing of more extensive clinical trials have been withdrawn. So the whole process in itself isn't flawless. I'm not saying the vaccines are unsafe or all the processes are wrong, but many people who are wary are often put in a corner of conspiracy theorists and I don't think this is fair.
- atleta 6y ago
  It's not flawless. But the point is not that it is flawless or that it should be (because, I don't think such a complex process can ever be). The point is that it gives you the best possible result as of now. Meaning, you have the highest chance for survival/avoiding a permanent health damage (which COVID can cause too) is taking an EMA/FDA approved vaccine. > but many people who are wary are often put in a corner of conspiracy theorists and I don't think this is fair. I think think this happens for at least two reasons. First, they are often simply conspiracy theorists who just try to phrase their thoughts in a way that doesn't seem like conspiracy theory at first. I've talked to a lot of people (mostly online) and I can tell you that it happens a lot. And the same people will start the same conversations again and again along the same patterns, pretending they are not conspiracy theorists or anti-vaxxers for that matter but go down the same path and show themselves if you engage in a discussion. Second, because of the above phenomenon, some people will just jump to the conclusion that anyone who raises concerns are indeed conspiracy theorists. (Again, because a lot of them will pretend that they are indeed sane people having sane questions.) It's not ideal, but not surprising either.
- treesprite82 6y ago
  > rushed trials, rushed production Fast doesn't mean rushed. The trials were fast because it was easy to gather huge numbers of participants, and the phases were carried out in parallel rather than sequentially (normally, to save money/resources, phase II would only start after a successful phase I). > and pressured approvals Immense pressure to make sure it's safe, too. Like this precautionary pause for what seems like a lower blood-clot rate than would be expected just by chance in that size of population.
serf 6y ago
>someone makes a claim that "AZ cuases bloog clots", I'm not sure if they ever looked into estimating and then comparing the said probabilities. I understand the stakes here regarding this discussion topic, but your tone is undeserved and unwarranted. >No, AZ does not cause blood clots. It's being investigated for it. Why is it being investigated for that specific side-effect? >You should trust the system and the process. Which system? Which process? If I'm German, French, Italian or Spanish then the system and process are at-odds with the AstraZeneca vaccine, no? Do we all just trust that our particular governing body is the all-wise entity that GotItRight, when opinions across the world and their respective governing bodies don't necessarily agree with one another? hard to blindly trust 'the system and process' at this point when 'the system and process' are fractured and dissimilar in nearly every region of the world. Some government must be making worse decisions than the rest. Blindly encouraging trust in unknown systems across the world at large isn't great for everyone. >And even if it does cause, you should take into account the probability. Absolutely agree.
- aroch 6y ago
  The answer to "Why are they investigating?" is simple and, in fact, driven in part by the pharmaceutical industry itself. First: The rate of thrombosis in AZ recipients is the less than it is in the general population -- Gen pop, ~.1% [1], AZ ~ 0.001% [2]. There is no evidence that the vaccine causes substantially higher risk. Also, the populations being prioritized for vaccination are a higher risk population for DVT to begin with.[1] AZ, along with effectively every pharma company out there of note, takes the reporting of adverse drug responses (ADRs) very, very seriously. Both FDA and EMA require ALL companies that produce a labeled product (aka a drug you can "buy" and isn't only available in a trial setting) to investigate and report on every instance of a reported potential ADR. Companies want to investigate because they want to be able to keep selling their drugs. Regulators want to investigate because they want to limit ADRs as much as possible. From the therapeutic point of view, it is bad if the treatment causes ADRs but also some may be unavoidable because of how the treatment works -- think chemo and cancer. The safety window for a drug is determined by balancing the therapeutic gain of treatment (usually, shorter time to recovery, increased QOL, or, in the case of cancers, increased life span/PFS) with the number and severity of known adverse effects. You might hear about cancer patients "cycling" their treatments, this is to allow time for the body to recover from known/expected ADRs. Any way, this was a long winded way of saying every entity involved -- drug manufacturer, regulators, doctors, patients -- wants reports of ADRs investigated. [1] https://www.ajmc.com/view/overview-of-venous-thromboembolism https://www.ajmc.com/view/overview-of-venous-thromboembolism "The overall incidence of VTE is 1 to 2 per 1000 person-years in the general population, which rises to 8 per 1000 person-years in people older than 85 years" [2] https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-prac-investigating-cases-thromboembolic-events-vaccines-benefits https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazene... 30/5,000,000

by atleta 6y ago

jMyles 6y ago

> You should trust the system and the process. I don't know which system and process you mean specifically, but I don't think that the system of approval under the FDA in the United States generally deserves our admiration or support. The current opioid crisis is a great case study in the tragedy of trust, profit, and death. As a scientifically literate society, we can do much better.

atleta 6y ago
I mean the scientific system and the vaccine/medication authorization process in general in the western world. (I don't know about the other parts, so can't comment.) Yes, I completely beleive that process of the FDA and/or the EMA can be improved and if so, it should. Still: - your best bet is trusting the current system as of now - improving the system is part of the system. That's what's hard for e.g. science denialists to understand. (Don't get me wrong, I'm not hinting you are one of them, just came to mind.)
- jMyles 6y ago
  > I mean the scientific system I have great confidence in the scientific method, precisely because it doesn't ask for my trust. The "scientific system" seems to be largely designed to obfuscate the implementation of that method. I can't help but notice that, even amidst social pressure for people to use these vaccines, the underlying data used to produce the reports remains unavailable, and will remain unavailable until the conclusion of the monitoring of phase III of the trials. I'm not sure I understand the reasons for that, and I'm quite sure that this is the first time in my life that mainstream scientists and medical journal editors have expressed such consternation about a vaccine approval process. > and the vaccine/medication authorization process in general in the western world I think it's not unfair to say that this process has failed and is no longer relevant in an internet-connected society. Countless cases demonstrate this, such as the capricious and scientifically unsound reject of cannabis happening contemporaneously with the approval of opioid preparations touted as non-habit forming, when even a single dose (of the drug and of common sense) easily refutes that claim. > - your best bet is trusting the current system as of now Why? When I can do my own research, access experts fairly directly, and make my own health care decisions? > - improving the system is part of the system. That's what's hard for e.g. science denialists to understand. (Don't get me wrong, I'm not hinting you are one of them, just came to mind.) I think everyone is interested in improvement. The question is which parts of "the system" have shown promise worth keeping. It seems to me that involvement of the state as a gatekeeper will necessarily result in this system being used for regulatory capture and profiteering first, and public health second or worse.
  - atleta 6y ago
    > I have great confidence in the scientific method, precisely because it doesn't ask for my trust. > The "scientific system" seems to be largely designed to obfuscate the implementation of that method. You are just playing around the specific words I've used. No one asked for your trust. I just said whoever is unsure about what to do, their best chance at the moment is trusting the system that is based on science (the scientific method). And also transparency. (Well, actually at any given moment. Besides working on trying to improve it.) Yes, there will always be inefficiencies and politics, etc. But even with that, your best bet is that. Because the alternatives are worse. > the underlying data used to produce the reports remains unavailable, and will remain unavailable Is this unusual? I don't know, just asking. What I know is that the Russian one, that we have bought a few millions here, doesn't have an EMA certificate yet but they have published their results in The Lancet. Now you can say that's still not the raw source data, and I agree, though scientists say that it's very unlikely to be falsified (and they are under the EMA process now anyway). > first time in my life that mainstream scientists and medical journal editors have expressed such consternation about a vaccine approval process. Who and where? Not trying to downplay it, but since it is happening under pressure (from the pandemic) since it is thus unusual it's unsurprising that there will be public criticism from inside the community as well. Under normal conditions, if they were about to change the process e.g. in preparation for something like this, it would be just a simple scientific/professional debate that we wouldn't hear about. > Why? When I can do my own research, access experts fairly directly, and make my own health care decisions? You can make your own decisions, of course. Everybody can. But you can't do your own research. I mean you can, but it's naive to think it will not be significantly worse than what's being done by the scientific community. You are alone, they are many (thousands, tens of thousands). You have basically no idea or very little idea, they have spent their life learning about one or two of the sub-fields that provide knowledge for vaccine development and safety testing. And, of course, these guys are doing it full time now, while you'll just invest a couple of hours (days, maybe weeks in the best case). I see a lot of smart people fall into this trap. There is a big difference in trying to understand the scientific results, the state of the art for the sake of understanding and between trying to somehow at some (arbitrary) level 're-evaluate' or 'check' the results and draw a contradicting conclusion. Verify whether all those science guys were right. You can't do that. I'd say that your chances are pretty slim, but I think in practice they are close to 0. Because you don't know what you don't know. You don't know what you are missing out. What you can do is try to make good decisions by trying to evaluate the the risks and the costs of the outcomes. E.g. you can say that getting a blood clot seems to be 1:167 000 from a vaccine (from the AZ one, but let's use that as an estimate for the others). You can get the numbers for the adverse outcomes for a COVID infection AND you can estimate your chance of actually contracting it. (Because the if you compare with the assumption that you get infected with a high chance then it's a no brainer.) Then you can adjust your behaviour, if it seems doable. E.g. you may be able to say that "OK, I'm waiting another year with the vaccine, because I'm not meeting anyone and not going to any closed public place, so my chances of contracting is really 0". That makes sense.

donovanian 6y ago

> You should trust the system and the process. If I'm supposed to be ok with small risks, why aren't any of the pharmaceuticals ok with the small risk that they've made a mistake and should be held liable? Why did they seek indemnity if there's no chance the vaccine could risk my health? I don't oppose the vaccine but this has never sat right with me.

chki 6y ago
This is not completely correct, at least in the EU there have not been any emergency vaccine authorisations by the EMA which means that pharmaceutical companies will be liable for mistakes that cause adverse health effects. In the UK there was an emergency authorisation which means that they will not be liable to the same degree. As for why they do this: There is always a small chance that the vaccine will cause adverse health effects because pharmaceutical stuff is very complex. Minimizing legal risks is a completely normal thing in all industries and part of the negotiation process. I would not draw the conclusion that they aren't 100% convinced of their vaccine but instead that their team of highly paid lawyers told them what was a good business decision.
- donovanian 6y ago
  You're being pretty generous, and I think it sounds reasonable but placed within the broader picture (and given how liberals generally consider profit-driven healthcare systems and industry in other circumstances...) it seems like people are looking to paper over some dastardly stuff and dismiss legitimate concerns so as to not "rock the boat." For instance: > Officials from Argentina and the other Latin American country, which cannot be named as it has signed a confidentiality agreement with Pfizer, said the company’s negotiators demanded more than the usual indemnity against civil claims filed by citizens who suffer serious adverse events after being inoculated. They said Pfizer also insisted the governments cover the potential costs of civil cases brought as a result of Pfizer’s own acts of negligence, fraud, or malice. In Argentina and Brazil, Pfizer asked for sovereign assets to be put up as collateral for any future legal costs. https://www.statnews.com/2021/02/23/pfizer-plays-hardball-in-covid19-vaccine-negotiations-in-latin-america/ https://www.statnews.com/2021/02/23/pfizer-plays-hardball-in... It'd be one thing if they were looking to defend against unforeseen damages. But this looks like they're trying to evade liability for crimes.

toshk 6y ago

It's not hard to imagine that rushed trials, rushed production and pressured approvals might not lead to the best process. Next to that: Over the last 50-60 years approved medicines with the backing of more extensive clinical trials have been withdrawn. So the whole process in itself isn't flawless. I'm not saying the vaccines are unsafe or all the processes are wrong, but many people who are wary are often put in a corner of conspiracy theorists and I don't think this is fair.

atleta 6y ago
It's not flawless. But the point is not that it is flawless or that it should be (because, I don't think such a complex process can ever be). The point is that it gives you the best possible result as of now. Meaning, you have the highest chance for survival/avoiding a permanent health damage (which COVID can cause too) is taking an EMA/FDA approved vaccine. > but many people who are wary are often put in a corner of conspiracy theorists and I don't think this is fair. I think think this happens for at least two reasons. First, they are often simply conspiracy theorists who just try to phrase their thoughts in a way that doesn't seem like conspiracy theory at first. I've talked to a lot of people (mostly online) and I can tell you that it happens a lot. And the same people will start the same conversations again and again along the same patterns, pretending they are not conspiracy theorists or anti-vaxxers for that matter but go down the same path and show themselves if you engage in a discussion. Second, because of the above phenomenon, some people will just jump to the conclusion that anyone who raises concerns are indeed conspiracy theorists. (Again, because a lot of them will pretend that they are indeed sane people having sane questions.) It's not ideal, but not surprising either.
treesprite82 6y ago
> rushed trials, rushed production Fast doesn't mean rushed. The trials were fast because it was easy to gather huge numbers of participants, and the phases were carried out in parallel rather than sequentially (normally, to save money/resources, phase II would only start after a successful phase I). > and pressured approvals Immense pressure to make sure it's safe, too. Like this precautionary pause for what seems like a lower blood-clot rate than would be expected just by chance in that size of population.

serf 6y ago

>someone makes a claim that "AZ cuases bloog clots", I'm not sure if they ever looked into estimating and then comparing the said probabilities. I understand the stakes here regarding this discussion topic, but your tone is undeserved and unwarranted. >No, AZ does not cause blood clots. It's being investigated for it. Why is it being investigated for that specific side-effect? >You should trust the system and the process. Which system? Which process? If I'm German, French, Italian or Spanish then the system and process are at-odds with the AstraZeneca vaccine, no? Do we all just trust that our particular governing body is the all-wise entity that GotItRight, when opinions across the world and their respective governing bodies don't necessarily agree with one another? hard to blindly trust 'the system and process' at this point when 'the system and process' are fractured and dissimilar in nearly every region of the world. Some government must be making worse decisions than the rest. Blindly encouraging trust in unknown systems across the world at large isn't great for everyone. >And even if it does cause, you should take into account the probability. Absolutely agree.

aroch 6y ago
The answer to "Why are they investigating?" is simple and, in fact, driven in part by the pharmaceutical industry itself. First: The rate of thrombosis in AZ recipients is the less than it is in the general population -- Gen pop, ~.1% [1], AZ ~ 0.001% [2]. There is no evidence that the vaccine causes substantially higher risk. Also, the populations being prioritized for vaccination are a higher risk population for DVT to begin with.[1] AZ, along with effectively every pharma company out there of note, takes the reporting of adverse drug responses (ADRs) very, very seriously. Both FDA and EMA require ALL companies that produce a labeled product (aka a drug you can "buy" and isn't only available in a trial setting) to investigate and report on every instance of a reported potential ADR. Companies want to investigate because they want to be able to keep selling their drugs. Regulators want to investigate because they want to limit ADRs as much as possible. From the therapeutic point of view, it is bad if the treatment causes ADRs but also some may be unavoidable because of how the treatment works -- think chemo and cancer. The safety window for a drug is determined by balancing the therapeutic gain of treatment (usually, shorter time to recovery, increased QOL, or, in the case of cancers, increased life span/PFS) with the number and severity of known adverse effects. You might hear about cancer patients "cycling" their treatments, this is to allow time for the body to recover from known/expected ADRs. Any way, this was a long winded way of saying every entity involved -- drug manufacturer, regulators, doctors, patients -- wants reports of ADRs investigated. [1] https://www.ajmc.com/view/overview-of-venous-thromboembolism https://www.ajmc.com/view/overview-of-venous-thromboembolism "The overall incidence of VTE is 1 to 2 per 1000 person-years in the general population, which rises to 8 per 1000 person-years in people older than 85 years" [2] https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-prac-investigating-cases-thromboembolic-events-vaccines-benefits https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazene... 30/5,000,000