I saw some conspiracy theory that said this weeks ago and just shook my head at how ridiculous that would be. At least it seemed like a conspiracy theory because my view of control group was apparently something else.
Emergency use authorization, for a vaccine that was never tested on humans, and both Pfizer and Moderna eliminated the control groups?
What the hell!? There must be… other or new control groups right? You can’t really have phase3 trials and reference nothing for control can you? What will they reference?
What conspiracy theory?
StatNews[1]:
> Pfizer and BioNTech speed up timeline for offering Covid-19 vaccine to placebo volunteers
> Pfizer and its partner BioNTech plan to offer their Covid-19 vaccine to any clinical trial volunteer who received placebo by March 1, several months earlier than initially planned.
and NPR[2]:
> Long-Term Studies Of COVID-19 Vaccines Hurt By Placebo Recipients Getting Immunized
> Tens of thousands of people who volunteered to be in studies of the Pfizer-BioNTech and Moderna COVID-19 vaccines are still participating in follow-up research. But some key questions won't be easily answered, because many people who had been in the placebo group have now opted to take the vaccine.
[1]: https://www.statnews.com/2021/01/01/pfizer-and-biontech-spee...
[2]: https://www.npr.org/sections/health-shots/2021/02/19/9691430...
Imagine you volunteered for a very experimental trial for the greater good and then were told that you were given a placebo and now cannot receive a vaccine for several years and will have to be more cautious. You can see in the article that a volunteer from the trial is strongly advocating for giving the participants access to vaccines.
Obviously this complicates the statistical analysis (you can try to use a double-blind crossover study to get some statistical power out of this, but clearly the messaging gets more complicated), but I'm not seeing anything about a "14 day" timeline.
It's also worth noting that any study participant can just freely choose to break the study and go in and get vaccinated (lowering the measured efficacy of the vaccine)_whenever they want. Giving them a concrete date is a good alternative to that.
In this specific situation, they would have been condemning through a choice to not treat, a fraction of the control group to die.
At the time they dissolved the control group, the fatality rate in control and placebo were the same. By their very own data they did not have a strong case that they would be "condemning...a fraction of the control group to die.". One would have to make a leap. A plausible leap, but a leap nonetheless.
Let's assume though that the fatality rate across the population for COVID was 1%, a very high number, to be conservative. So in that case you'd expect ~150 preventable fatalities in the control group. We now have ~that many fatalities, in a single state (Massachusetts), from COVID-19, in people who were "fully vaccinated".
You can do the math and extrapolate that there are now orders of magnitude more deaths from "breakthrough infections" than might have been in the placebo control group. If we had known that the efficacy of these vaccines was going to fall significantly, might some of those deaths have been prevented? I think there's an argument to be made there.
Now we have statisticians scrambling over themselves with complex methods to figure out what the hell is going on, when we could have had the gold standard which would be quite simple to interpret, if we had kept those control groups.
Now some argue it would have been completely impractical to maintain that control group amidst a mass vax campaign (I think we should have tried, regardless). I think there's room to debate that. But in that case I think we need a vast upgrade to our data infra, because giving up the placebo control group was a huge loss (for truth and science, at least).
That doesn’t actually seem right though. You have control groups at least through all phases of trials to make sure “the treatment works”. That’s literally the point of the control.
Especially now that we know the vaccines don’t completely work to stop infection or prevent symptoms or spread.
I’m all for the vaccines, but it seems crazy that they didn’t even wait until phase3 was over for a new type that has never been tested on humans before.
If the argument is “the control petiole were at risk”, they should have been told their vaccine was placebo and ask for volunteers to remain in control, seems like flat out offering them real shot defeats the point, doesn’t it?
It seems you can force people to get a vaccine in the middle of a pandemic. France is dealing with massive unrest [0] and are hemorrhaging medical staff [1] because they mandated vaccines for medical professionals (which doesn't make sense, the vaccine doesn't prevent a person from spreading the virus [2]).
[0] https://spectator.org/french-health-pass-riots/
[1] https://www.reuters.com/world/europe/we-have-rights-french-h...
[2] https://www.realclearpolitics.com/video/2021/08/06/cdc_direc...!
