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There was never going to be a two year control group. The moment somebody in a trial could get vaccinated via some other channel, they'd drop out and get unblin

by jsnell 6y ago

There was never going to be a two year control group. The moment somebody in a trial could get vaccinated via some other channel, they'd drop out and get unblinded. Anything else would make it much harder to get people to participate in the study. For Covid, there's an additional problem with antibody tests being relatively abundant, and would allow the participants to unblind themselves anyway.

breck 6y ago
> There was never going to be a two year control group. Actual Study Start Date: July 27, 2020 Estimated Primary Completion Date: October 27, 2022 [0] https://clinicaltrials.gov/ct2/show/NCT04470427 https://clinicaltrials.gov/ct2/show/NCT04470427 I thought there was going to be a two year control group because that was the plan published on ClinicalTrials.gov run by NIH. > The moment somebody in a trial could get vaccinated via some other channel, they'd drop out and get unblinded If this is such obvious common knowledge why wasn't it in the plan? Why isn't it in the training? I am 100% open to fundamentally and drastically changing the way we test medicines and vaccines et cetera, but that's very different than just making decisions willy nilly that just so happen to align 100% with shareholder interests.
- jsnell 6y ago
  The trial protocol allows for a participant to leave at any time for any reason. It does not require the participants to not get another vaccine if one becomes available. They'd obviously do that if possible, because there was a 50/50 chance they had gotten the Placebo. Both the treatment and control groups would start to disintegrate the moment a vaccine gets approved for an EUA. (But fair enough; in the case that no vaccine got an EUA, the control group would have lasted for two years.) All that the protocol change to give the control group the Moderna vaccine at that point did was to let them at least continue with the observational open-label phase B of the study. Your suggestion that this a sinister plot to hide the long-term inefficacy of their vaccines is absurd. A Covid vaccine that was highly effective for only a couple of years would be a goldmine in the long term, and would sell just as well right now.
  - breck 6y ago
    > The trial protocol allows for a participant to leave at any time for any reason. Exactly. And some would. But most would not. Just like every other randomized control study. It boggles the mind to say "let's tell everyone they got the placebo, because some people might leave". That does not follow logic. > plot to hide the long-term inefficacy of their vaccines is absurd. What part of that is absurd? At the time the control groups were destroyed, there was no evidence that the vaccines were saving lives (https://www.fda.gov/media/144434/download https://www.fda.gov/media/144434/download — 7 deaths in placebo group; 7 in control group). Now, if you got tens of billions of dollars based on those early results, wouldn't you have *strong* incentives to shut things down, and not wait for the long-term verdict? What would you have to gain if 2 years in, the placebo group continued to have just as few deaths as the vaccine group? Are you saying that the idea that humans respond to incentives is absurd?
    - jsnell 6y ago
      > But most would not. How could that possibly be true? Basically everyone who isn't a rabid anti-vaxxer is trying to get a Covid shot as soon as possible. And pretty obviously none of the participants in a vaccination study is going to be an anti-vaxxer. > 7 deaths in placebo group; 7 in control group That's not true. Why in the world would you fib about something that is this easy to verify? There were 3 deaths in the treatment group, 4 in the control. But more to the point, there were no deaths from Covid in either group. It's not that "7 people died of Covid in the treatment group" which you were clearly trying to imply. Now, why were there no deaths from Covid? Because the size of the trial was set such that they could reasonably expect to find an effect for preventing symptomatic disease. That's why it was the primary endpoint. Why couldn't they run a trial where Covid deaths were the endpoint? Because the IFR of Covid is "only" 1%. To run a trial that could reliably show an effect on the number of deaths, you'd be looking at 100x the participants. I'm sure you're not seriously suggesting running a trial of 3M people. > Are you saying that the idea that humans respond to incentives is absurd? No. I think your suggestions on what Moderna's incentives are absurd. Think about it for a bit: the early results showed no change in the number of deaths. You're suggesting that if they waited and... ummm.. showed no change in the number of deaths, it'd somehow lose them tens of billions. I can't help but notice that the before and after are the same there: "not showing a change in the number of deaths". But also, that's 1.5 years from now. There's a lot of vaccines to be sold right now, and that's what their incentives would be focused on. Not on hypothetical effects that their trial was not designed to surface in the first place. And again, the foundation for this theory is that the trial participants would have agreed to not get a working vaccination for two years, even if on placebo. You've not presented any proof for this except claims about "NIH training".

by jsnell 6y ago

breck 6y ago

> There was never going to be a two year control group. Actual Study Start Date: July 27, 2020 Estimated Primary Completion Date: October 27, 2022 [0] https://clinicaltrials.gov/ct2/show/NCT04470427 https://clinicaltrials.gov/ct2/show/NCT04470427 I thought there was going to be a two year control group because that was the plan published on ClinicalTrials.gov run by NIH. > The moment somebody in a trial could get vaccinated via some other channel, they'd drop out and get unblinded If this is such obvious common knowledge why wasn't it in the plan? Why isn't it in the training? I am 100% open to fundamentally and drastically changing the way we test medicines and vaccines et cetera, but that's very different than just making decisions willy nilly that just so happen to align 100% with shareholder interests.

jsnell 6y ago
The trial protocol allows for a participant to leave at any time for any reason. It does not require the participants to not get another vaccine if one becomes available. They'd obviously do that if possible, because there was a 50/50 chance they had gotten the Placebo. Both the treatment and control groups would start to disintegrate the moment a vaccine gets approved for an EUA. (But fair enough; in the case that no vaccine got an EUA, the control group would have lasted for two years.) All that the protocol change to give the control group the Moderna vaccine at that point did was to let them at least continue with the observational open-label phase B of the study. Your suggestion that this a sinister plot to hide the long-term inefficacy of their vaccines is absurd. A Covid vaccine that was highly effective for only a couple of years would be a goldmine in the long term, and would sell just as well right now.
- breck 6y ago
  > The trial protocol allows for a participant to leave at any time for any reason. Exactly. And some would. But most would not. Just like every other randomized control study. It boggles the mind to say "let's tell everyone they got the placebo, because some people might leave". That does not follow logic. > plot to hide the long-term inefficacy of their vaccines is absurd. What part of that is absurd? At the time the control groups were destroyed, there was no evidence that the vaccines were saving lives (https://www.fda.gov/media/144434/download https://www.fda.gov/media/144434/download — 7 deaths in placebo group; 7 in control group). Now, if you got tens of billions of dollars based on those early results, wouldn't you have *strong* incentives to shut things down, and not wait for the long-term verdict? What would you have to gain if 2 years in, the placebo group continued to have just as few deaths as the vaccine group? Are you saying that the idea that humans respond to incentives is absurd?
  - jsnell 6y ago
    > But most would not. How could that possibly be true? Basically everyone who isn't a rabid anti-vaxxer is trying to get a Covid shot as soon as possible. And pretty obviously none of the participants in a vaccination study is going to be an anti-vaxxer. > 7 deaths in placebo group; 7 in control group That's not true. Why in the world would you fib about something that is this easy to verify? There were 3 deaths in the treatment group, 4 in the control. But more to the point, there were no deaths from Covid in either group. It's not that "7 people died of Covid in the treatment group" which you were clearly trying to imply. Now, why were there no deaths from Covid? Because the size of the trial was set such that they could reasonably expect to find an effect for preventing symptomatic disease. That's why it was the primary endpoint. Why couldn't they run a trial where Covid deaths were the endpoint? Because the IFR of Covid is "only" 1%. To run a trial that could reliably show an effect on the number of deaths, you'd be looking at 100x the participants. I'm sure you're not seriously suggesting running a trial of 3M people. > Are you saying that the idea that humans respond to incentives is absurd? No. I think your suggestions on what Moderna's incentives are absurd. Think about it for a bit: the early results showed no change in the number of deaths. You're suggesting that if they waited and... ummm.. showed no change in the number of deaths, it'd somehow lose them tens of billions. I can't help but notice that the before and after are the same there: "not showing a change in the number of deaths". But also, that's 1.5 years from now. There's a lot of vaccines to be sold right now, and that's what their incentives would be focused on. Not on hypothetical effects that their trial was not designed to surface in the first place. And again, the foundation for this theory is that the trial participants would have agreed to not get a working vaccination for two years, even if on placebo. You've not presented any proof for this except claims about "NIH training".