Studies demonstrating HPV vaccine is both safe and effective - Page 6

[Taximom5]

Originally Posted by Rrrrrachel 

The thing about gardasil not being tested with a true placebo didn't sit right with me.  I think having everything but the pathogen as a placebo is legit, but at some point it was surely tested against saline.  Turns out, it was.

From the gardasil insert:

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111263.pdf

Not really--the results from the saline placebo were mixed together with the results of the AAHS "placebo."

Net result:  we never got to see how either Gardasil nor AAHS compared with the saline placebo, and the placebo "results" were skewed, since saline is obviously safer than AAHS.

In other words, the study was severely flawed.

[Rrrrrachel]

Tha

Originally Posted by Taximom5 

Not really--the results from the saline placebo were mixed together with the results of the AAHS "placebo."


Net result:  we never got to see how either Gardasil nor AAHS compared with the saline placebo, and the placebo "results" were skewed, since saline is obviously safer than AAHS.

In other words, the study was severely flawed.

This is not true. The insert shows the rate for the vax, alum control, and saline placebo all broken out separately.

[Minerva23]

Quote from Rrrrrachel: The thing about gardasil not being tested with a true placebo didn't sit right with me.  I think having everything but the pathogen as a placebo is legit, but at some point it was surely tested against saline.  Turns out, it was.

From the gardasil insert:

Quote:

 

In 7 clinical trials (5 Amorphous Aluminum Hydroxyphosphate Sulfate [AAHS]-controlled, 1 saline 

placebo-controlled, and 1 uncontrolled), 18,083 individuals were administered GARDASIL or AAHS 

control or saline placebo on the day of enrollment, and approximately 2 and 6 months thereafter, and 

safety was evaluated using vaccination report cards (VRC)-aided surveillance for 14 days after each 

injection of GARDASIL or AAHS control or saline placebo in these individuals. 

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111263.pdf

Did you read the entire thing? Well, I guess the positive side of this would be that they actually treated a group with just saline placebo. But when you look at the number of participants and how evenly they are distributed among the 3 groups, just makes me wonder.  There are only 594 people in the saline group and this group was just mixed in with the AAHS group when side effects were listed. Which in turn probably balanced the odds in favor for Gardasil = not significantly different than the placebo group! Not at all convincing!

"Across the clinical studies, 40 deaths (GARDASIL N = 21 or 0.1%; placebo N = 19 or 0.1%) were reported in 29,323

(GARDASIL N = 15,706; AAHS control N = 13,023, saline placebo N = 594) individuals (9- through 45-year-old girls and women; and 9- through 26-year-old boys and men)." (from the link above)

[Minerva23]

Originally Posted by Rrrrrachel 

Tha
This is not true. The insert shows the rate for the vax, alum control, and saline placebo all broken out separately.

Not for all groups though. On some it shows the saline group seperately but in others and the end result AAHS and saline are combined.

[Rrrrrachel]

Originally Posted by Minerva23 

Quote from Rrrrrachel: The thing about gardasil not being tested with a true placebo didn't sit right with me.  I think having everything but the pathogen as a placebo is legit, but at some point it was surely tested against saline.  Turns out, it was.

From the gardasil insert:



http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111263.pdf




Did you read the entire thing? Well, I guess the positive side of this would be that they actually treated a group with just saline placebo. But when you look at the number of participants and how evenly they are distributed among the 3 groups, just makes me wonder.  There are only 594 people in the saline group and this group was just mixed in with the AAHS group when side effects were listed. Which in turn probably balanced the odds in favor for Gardasil = not significantly different than the placebo group! Not at all convincing!

"Across the clinical studies, 40 deaths (GARDASIL N = 21 or 0.1%; placebo N = 19 or 0.1%) were reported in 29,323
(GARDASIL N = 15,706; AAHS control N = 13,023, saline placebo N = 594) individuals (9- through 45-year-old girls and women; and 9- through 26-year-old boys and men)." (from the link above)

There's no reason that the difference in numbers would stack the odds in favor of gardasil at all. Are you familiar with how large placebo groups usually are for drug trials?

[Minerva23]

Originally Posted by Rrrrrachel 


There's no reason that the difference in numbers would stack the odds in favor of gardasil at all. Are you familiar with how large placebo groups usually are for drug trials?

Yes, I am aware of that.

[pek64]

Would everyone here agree that the saline placebo probably didn't cause any deaths, so the 19 were in the AAHS control group?

[Rrrrrachel]

So then why the erroneous claim that the smaller placebo group stacks the deck?

[kathymuggle]

Originally Posted by pek64 

Would everyone here agree that the saline placebo probably didn't cause any deaths, so the 19 were in the AAHS control group?

  

[erigeron]

Originally Posted by pek64 

Would everyone here agree that the saline placebo probably didn't cause any deaths, so the 19 were in the AAHS control group?

Depends on which deaths we are discussing and if they are related to the study drug. If they include ALL deaths including accidents & other unrelated ones, some could be in the saline group. 

[Rrrrrachel]

No, it doesn't work like that. 19 people died in the saline placebo group due to other causes. The whole purpose of a control group is to have something to compare against that measures "random background noise"

[pek64]

Originally Posted by Rrrrrachel 

No, it doesn't work like that. 19 people died in the saline placebo group due to other causes. The whole purpose of a control group is to have something to compare against that measures "random background noise"

Not the saline placebo group. The AAHS and saline combined group.

[Rrrrrachel]

Well whichever, you absolutely cannot assume they're all in the alum placebo group. That's nonsense.

[pek64]

Originally Posted by Rrrrrachel 

Well whichever, you absolutely cannot assume they're all in the alum placebo group. That's nonsense.

Which takes us back to ...

Originally Posted by Taximom5 

Not really--the results from the saline placebo were mixed together with the results of the AAHS "placebo."


Net result:  we never got to see how either Gardasil nor AAHS compared with the saline placebo, and the placebo "results" were skewed, since saline is obviously safer than AAHS.

In other words, the study was severely flawed.

[Rrrrrachel]

But they weren't. I'm sorry you can't see them broken out in every single place, but that doesn't mean a distinction wasn't drawn.

[pek64]

A *flawed* distinction was drawn.

[Minerva23]

Originally Posted by Rrrrrachel 

But they weren't. I'm sorry you can't see them broken out in every single place, but that doesn't mean a distinction wasn't drawn.

But apparently the distinction was not wanted to be drawn that clearly. Why not split the placebo group equally instead of  AAHS control N = 13,023, saline placebo N = 594 and then mix these 2 groups together to get a result which is close to that of the gardasil group.

[Rrrrrachel]

Have either of you read the actual study or are you making a bunch of assumptions based on some very brief summaries you've read?

One reason not to split the group evenly is you need enough subjects in the gardasil and aahs group to have sufficient statistical power to detect adverse events with small likelihoods. It's not nearly as simple as you seem to think it is. Nor is it necessary to have a placebo group that large, it would gain you nothing while costing you a lot.

[pek64]

Originally Posted by Rrrrrachel 

Have either of you read the actual study or are you making a bunch of assumptions based on some very brief summaries you've read?
One reason not to split the group evenly is you need enough subjects in the gardasil and aahs group to have sufficient statistical power to detect adverse events with small likelihoods. It's not nearly as simple as you seem to think it is. Nor is it necessary to have a placebo group that large, it would gain you nothing while costing you a lot.

I have been pointing out the assumptions the pro-vax side has been making. If there are actual numbers that show a different picture, by all means, post them. I prefer numbers over assumptions.

A large placebo group would gain the identification of adverse reactions to the AAHS components.

It seems the choice to have a small placebo group is simply to muddy the evidence of adverse reactions caused by vaccinations. If there is nothing to hide, why the misdirection?

[Rrrrrachel]

Pek, I keep trying to explain this, I don't know if you have any statistical training, but that's just not true.