6 ms·

I'm inclined to agree, but I must ask: Would you have the same standards when it comes to the vaccines? I'm not aware of any double-blind placebo-controlled tr

I'm inclined to agree, but I must ask: Would you have the same standards when it comes to the vaccines? I'm not aware of any double-blind placebo-controlled trial that is powerful enough to determine risk reduction for death or severe disease in vaccines, much less over several months.

cloutchaser 5y ago
As far as I know this was explained away with - it's too urgent and it's not ethical to have placebo controlled vaccine trials at this time, since everyone will contract covid. So we didn't have any.
- incrudible 5y ago
  An all-too-convenient excuse, considering how many people now willingly put themselves into the control group called "anti-vaxxer".
- ericb 5y ago
  The vaccine studies were placebo controlled.
  - incrudible 5y ago
    The trials are ongoing, but the placebo group has long been vaccinated.
    - jlbooker 5y ago
      The trials lasted long enough to gather the statistical evidence needed to show that the vaccine prevented the trial group from becoming infected (and that it was highly unlikely the trial group did better due to random chance). When that point was reached, the trial was deemed sufficient and was ended/unblinded. When people are dying by the thousands every day (in the USA alone), how much longer would you have wanted the trial to go on? We found out what we wanted to know. The vaccine worked. There's no need to carry on and ask the placebo group to continue with the risk of being infected.
      - Vrondi 5y ago
        One of the things that has made it hard to believe the drug companies behind the new vaccines are trustworthy is the way that they and the medical establishment has continuously claimed that these vaccines have good long-term safety, when long-term safety wasn't even something that was being tested for, and a long term hasn't yet elapsed. Such claims were being spouted by government and medical people even before the EUA was finalized, which makes the entire thing seem quite untrustworthy to anyone who was looking at the actual situation and research.
        trembonator 5y ago
      - incrudible 5y ago
        I'm not going to argue the ethics, I'm going to argue that these trials are under-powered and insufficient to make bold claims about vaccine efficacy. The trials are in fact not completed until the end of the year, but there is little further information to be gained after dissolution of the placebo group. Remember, the people defending Ivermectin also argue that it's unethical to do further trials when it is "clearly effective" (according to under-powered studies). Consider that pharma companies deliberately avoid follow-up trials to avoid finding results that don't align with business interest. Remdesivir and Molnupiravir both looked promising in early trials, but were found to be rather ineffective (and dangerous) in later trials. I don't have a problem with administering drugs/vaccines based on good faith and speculative benefit if that is declared appropriately. Just don't dress it up as "scientifically validated".
        cloutchaser 5y ago
        And they don’t have any incentive to do so. Most governments, on almost any political side have decided vaccines are the solution full stop. They don’t want to be proved wrong and have no incentive to investigate. Drug companies also have no incentive. I agree with your last sentence a lot, we can do a lot of things and administer a lot of things, just don’t say “an attack on it is an attack on science”
- rsfern 5y ago
  The clinical trials were placebo controlled, see the sibling comment for a reference to the results, or look up the protocols on clinicaltrials.gov
iandanforth 5y ago
I'm not sure I understand your statement https://www.nejm.org/doi/full/10.1056/nejmoa2035389 https://www.nejm.org/doi/full/10.1056/nejmoa2035389 showed an absurdly large effect in a controlled blinded trial which was at least part of the reason emergency approval was granted.
- incrudible 5y ago
  Yes, we did observe a large effect within the first months in an immunocompetent middle-aged population, but as we all know now, that effect doesn't last very long. The placebo group has been unblinded and vaccinated, so we wouldn't know how they fared in the long run.
  - acdha 5y ago
    > but as we all know now, that effect doesn't last very long. What, precisely, do you think we know? The vaccines were tested against the first strain so it's not surprising that they lost effectiveness at preventing infection entirely against variants like Omicron with significantly greater immune evasion but even there we still see massive benefits against severe cases. The current performance of the mRNA vaccines against Omicron is still better than many people cautioned would considered a good result for the first iteration of a vaccine created for a new virus.
    - incrudible 5y ago
      Consistent waning of efficacy against infection over time has been observed regardless of variants[1]. At the same time, we didn't see "massive benefit" against severe cases in breakthrough infections in a matched cohort study[2]. This leads me to suspect that current statistical observations do not reflect reality and may well be artifacts. Paradoxically, we're also observing increased odds of Omikron infection after (two dose) vaccination. Furthermore, we're administering boosters even to teenagers based on good faith, not good science. Hence, there still is a need for placebo-controlled trials. [1] https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3949410 https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3949410 [2] https://www.medrxiv.org/content/10.1101/2021.10.26.21265508v1 https://www.medrxiv.org/content/10.1101/2021.10.26.21265508v...

cloutchaser 5y ago

As far as I know this was explained away with - it's too urgent and it's not ethical to have placebo controlled vaccine trials at this time, since everyone will contract covid. So we didn't have any.

incrudible 5y ago
An all-too-convenient excuse, considering how many people now willingly put themselves into the control group called "anti-vaxxer".
ericb 5y ago
The vaccine studies were placebo controlled.
- incrudible 5y ago
  The trials are ongoing, but the placebo group has long been vaccinated.
  - jlbooker 5y ago
    The trials lasted long enough to gather the statistical evidence needed to show that the vaccine prevented the trial group from becoming infected (and that it was highly unlikely the trial group did better due to random chance). When that point was reached, the trial was deemed sufficient and was ended/unblinded. When people are dying by the thousands every day (in the USA alone), how much longer would you have wanted the trial to go on? We found out what we wanted to know. The vaccine worked. There's no need to carry on and ask the placebo group to continue with the risk of being infected.
    - Vrondi 5y ago
      One of the things that has made it hard to believe the drug companies behind the new vaccines are trustworthy is the way that they and the medical establishment has continuously claimed that these vaccines have good long-term safety, when long-term safety wasn't even something that was being tested for, and a long term hasn't yet elapsed. Such claims were being spouted by government and medical people even before the EUA was finalized, which makes the entire thing seem quite untrustworthy to anyone who was looking at the actual situation and research.
      - trembonator 5y ago
    - incrudible 5y ago
      I'm not going to argue the ethics, I'm going to argue that these trials are under-powered and insufficient to make bold claims about vaccine efficacy. The trials are in fact not completed until the end of the year, but there is little further information to be gained after dissolution of the placebo group. Remember, the people defending Ivermectin also argue that it's unethical to do further trials when it is "clearly effective" (according to under-powered studies). Consider that pharma companies deliberately avoid follow-up trials to avoid finding results that don't align with business interest. Remdesivir and Molnupiravir both looked promising in early trials, but were found to be rather ineffective (and dangerous) in later trials. I don't have a problem with administering drugs/vaccines based on good faith and speculative benefit if that is declared appropriately. Just don't dress it up as "scientifically validated".
      - cloutchaser 5y ago
        And they don’t have any incentive to do so. Most governments, on almost any political side have decided vaccines are the solution full stop. They don’t want to be proved wrong and have no incentive to investigate. Drug companies also have no incentive. I agree with your last sentence a lot, we can do a lot of things and administer a lot of things, just don’t say “an attack on it is an attack on science”
rsfern 5y ago
The clinical trials were placebo controlled, see the sibling comment for a reference to the results, or look up the protocols on clinicaltrials.gov

iandanforth 5y ago

I'm not sure I understand your statement https://www.nejm.org/doi/full/10.1056/nejmoa2035389 https://www.nejm.org/doi/full/10.1056/nejmoa2035389 showed an absurdly large effect in a controlled blinded trial which was at least part of the reason emergency approval was granted.

incrudible 5y ago
Yes, we did observe a large effect within the first months in an immunocompetent middle-aged population, but as we all know now, that effect doesn't last very long. The placebo group has been unblinded and vaccinated, so we wouldn't know how they fared in the long run.
- acdha 5y ago
  > but as we all know now, that effect doesn't last very long. What, precisely, do you think we know? The vaccines were tested against the first strain so it's not surprising that they lost effectiveness at preventing infection entirely against variants like Omicron with significantly greater immune evasion but even there we still see massive benefits against severe cases. The current performance of the mRNA vaccines against Omicron is still better than many people cautioned would considered a good result for the first iteration of a vaccine created for a new virus.
  - incrudible 5y ago
    Consistent waning of efficacy against infection over time has been observed regardless of variants[1]. At the same time, we didn't see "massive benefit" against severe cases in breakthrough infections in a matched cohort study[2]. This leads me to suspect that current statistical observations do not reflect reality and may well be artifacts. Paradoxically, we're also observing increased odds of Omikron infection after (two dose) vaccination. Furthermore, we're administering boosters even to teenagers based on good faith, not good science. Hence, there still is a need for placebo-controlled trials. [1] https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3949410 https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3949410 [2] https://www.medrxiv.org/content/10.1101/2021.10.26.21265508v1 https://www.medrxiv.org/content/10.1101/2021.10.26.21265508v...