Wonderful article! It really is hopeful how much good the HPV Vaccination has done. I was in high school when the HPV vaccine became readily available in the 2000s. Of course, I got it happily. But I will never forget how some girls’ parents refused to vaccinate them, thinking it would lead to sexual promiscuity.
Thank you for this information. I’m glad that my grandchildren have been vaccinated and likely won’t have to go through surgeries that I’ve had due to HPV.
The Gardasil HPV vaccine is a case study of the biases in vaccine science.
If you look at the Gardasil HPV vaccine, a non-inert placebo was used (containing aluminum adjuvant) as the basis of comparison.
There was a "token saline placebo group" but it appears to be "deliberately underpowered" (look at the N sizes of the placebo groups) so that adverse effects wouldn't be found.
Excellent demonstration of complete ignorance about this issue. Phase-3 controlled trials aren't powered for safety outcome measures - where appropriate analyses would permit findings of statistical significance. DUH!
Large dedicated safety trials aren't a thing. Open-label safety followup periods are.
If specific concerns or signals emerge during development, dedicated studies or outcome measures would be required - for approval, or as Phase-4 commitments. Approval may require supplemental tracking and analyses of specific "SAEs of special interest," in addition to all usual periodic and expedited reporting.
Anti-science? Since when did "biasing the methodology to give the outcome you want" become part of "anti-science"? I suppose if the goal of your science were Big Pharma $$$....
I admire your eagerness to humiliate yourself even further. You have no conception of the meaning of what you pasted as your own criticism.
"There was a "token saline placebo group" but it appears to be "deliberately underpowered" (look at the N sizes of the placebo groups) so that adverse effects wouldn't be found."
Just search "underpowered study" and/or "overpowered study"
I see you are getting emotional, but a rational, more rigorous approach is needed here.
From your links – "A study with low statistical power has a reduced chance of detecting a true effect, but it is less well appreciated that low power also reduces the likelihood that a statistically significant result reflects a true effect."
My contention is that the deliberate low-statistical power of the saline group would make it impossible to detect true vaccine injury within the study cohorts.
I'm going to dispute what you said. The purpose of phase-3 controlled trials is demonstrate efficacy and safety of sufficient nature to warrant FDA approval.
Before any new public can be offered to the public, it must be shown as safe. This is the mandate of the FDA.
You dodge my main point here in that methodology used in this phase-3 controlled trial appears to be manipulated for the benefit of Big Pharma.
Moreover, we all know that post-marketing surveillance of vaccine injury is critically flawed. You only need look at the debacle with the COVID vaccines to see that. There are nearly 40,000 reported deaths in VAERS and very little subsequent action by regulators.
Wonderful article! It really is hopeful how much good the HPV Vaccination has done. I was in high school when the HPV vaccine became readily available in the 2000s. Of course, I got it happily. But I will never forget how some girls’ parents refused to vaccinate them, thinking it would lead to sexual promiscuity.
Thank you for this information. I’m glad that my grandchildren have been vaccinated and likely won’t have to go through surgeries that I’ve had due to HPV.
Unbiased science that promotes pharmaceutical drugs...I see the cognitive dissonance is strong in this substack.
Here come the anti-vax crazies again. How about turning off comments?
The Gardasil HPV vaccine is a case study of the biases in vaccine science.
If you look at the Gardasil HPV vaccine, a non-inert placebo was used (containing aluminum adjuvant) as the basis of comparison.
There was a "token saline placebo group" but it appears to be "deliberately underpowered" (look at the N sizes of the placebo groups) so that adverse effects wouldn't be found.
There are problems here.
https://www.fda.gov/files/vaccines,%20blood%20&%20biologics/published/Package-Insert---Gardasil.pdf
Excellent demonstration of complete ignorance about this issue. Phase-3 controlled trials aren't powered for safety outcome measures - where appropriate analyses would permit findings of statistical significance. DUH!
Large dedicated safety trials aren't a thing. Open-label safety followup periods are.
If specific concerns or signals emerge during development, dedicated studies or outcome measures would be required - for approval, or as Phase-4 commitments. Approval may require supplemental tracking and analyses of specific "SAEs of special interest," in addition to all usual periodic and expedited reporting.
This was probably a copy/paste from another brainwashed MAHA.
Like nearly all this garden variety anti-science drivel.
Anti-science? Since when did "biasing the methodology to give the outcome you want" become part of "anti-science"? I suppose if the goal of your science were Big Pharma $$$....
Spare me your "big pharma $$$" bullshit.
These are basic definitions used in statistics.
I admire your eagerness to humiliate yourself even further. You have no conception of the meaning of what you pasted as your own criticism.
"There was a "token saline placebo group" but it appears to be "deliberately underpowered" (look at the N sizes of the placebo groups) so that adverse effects wouldn't be found."
Just search "underpowered study" and/or "overpowered study"
https://www.nature.com/articles/nrn3475
https://www.statisticsdonewrong.com/power.html
I see you are getting emotional, but a rational, more rigorous approach is needed here.
From your links – "A study with low statistical power has a reduced chance of detecting a true effect, but it is less well appreciated that low power also reduces the likelihood that a statistically significant result reflects a true effect."
My contention is that the deliberate low-statistical power of the saline group would make it impossible to detect true vaccine injury within the study cohorts.
Did you understand the arguments I made? Do you know how to read a study?
YOU don't understand the arguments that "you" made.
Amazing!
Acting condescending doesn't advance your scientific argument nor make you more credible. Can you explain your contentions?
I'm not making any sort of "scientific argument."
Skip the bullshit about not addressing your "methodological critique," because my initial comment did.
"Own research" poster boys demand condescension.
I'm going to dispute what you said. The purpose of phase-3 controlled trials is demonstrate efficacy and safety of sufficient nature to warrant FDA approval.
Before any new public can be offered to the public, it must be shown as safe. This is the mandate of the FDA.
You dodge my main point here in that methodology used in this phase-3 controlled trial appears to be manipulated for the benefit of Big Pharma.
Moreover, we all know that post-marketing surveillance of vaccine injury is critically flawed. You only need look at the debacle with the COVID vaccines to see that. There are nearly 40,000 reported deaths in VAERS and very little subsequent action by regulators.
Consider trying to learn something. Decent explanation here;
https://blogs.bmj.com/bmjebmspotlight/2017/11/14/rare-adverse-events-clinical-trials-understanding-rule-three/
This is a non-sequitur. I'm pointing out that the methodology in the safety trial was biased and the saline appears deliberately under-powered.