Studies demonstrating HPV vaccine is both safe and effective - Page 7

[pek64]

Originally Posted by Rrrrrachel 

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

Perhaps an example can show the error.

[Rrrrrachel]

Unfortunately in the statistics classes I teach which start in May we don't get to that topic until after Christmas, so it's not that simple.

[pek64]

More avoidance.

Well, I've enjoyed playing tonight, but I must go now. Maybe next time we can be on a new thread, with a new topic, and actual data. That would be refreshing!

[Rrrrrachel]

Pek, it's not avoidance to say I can't boil down a junior level undergraduate statistics course to a succinct little forum post for you.  

[chickabiddy]

Here's some actual data to read: http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm111263.pdf

[WildKingdom]

Originally Posted by pek64 

More avoidance.
Well, I've enjoyed playing tonight, but I must go now. Maybe next time we can be on a new thread, with a new topic, and actual data. That would be refreshing!

There's plenty of data on this thread. It just has to be read and understood.

Here's a primer regarding statistical power.  You know, they don't just pull these sample sizes out their asses. 

And the point is not to make all groups the same size.  That means nothing.

http://www.indiana.edu/~statmath/stat/all/power/power.html

[kathymuggle]

Originally Posted by Rrrrrachel 


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

If we are looking at the link you cited (which yes, I read) in some areas reactions are broken out separately, and in some areas they stick the rates for AAHS and saline together.  They seem to separate out the milder reactions, but some of the more severe reactions they lump together.  I get one of the reasons they may do this (the saline group is pretty small - and actually getting data out of that small group on severe reactions might be hard as severe reactions are rarer) - but it still does not give us much information on reaction rate in HPV vaxxed versus unvaxxed. 

Originally Posted by Rrrrrachel 


There's no reason that the difference in numbers would stack the odds in favor of gardasil at all. 

It could.

Some made up numbers to illustrate the point.

Incidence of fever in 10 day period following injection:

saline - 10%

AAHS - 45%

Gardasil - 60%

In the study in question, those in the saline group only made up about 10% of the AAHS/saline contingent.

The math on the combined AAHS/Saline group is 41.5 %. (10% of 10%, plus 90% of 45%).

Gardasil still has a 60% fever rate, but it looks safer when you compare it to a AAHS/Saline control than when you compare it to Saline alone.

[Rrrrrachel]

Right but aahs is a control. We've already addressed that.

[kathymuggle]

Originally Posted by Rrrrrachel 

Right but aahs is a control. We've already addressed that.

Yes - but I think we have also established that some of us are interested in numbers in a saline control group (not a AAHS/saline control group)  

I think that has been the bone of contention over the last page.

[Rrrrrachel]

Sure, but you not getting the number you're interested in every single break down you want it in in the summary that has to fit on the insert and not even talking about the full study is not the same as being intentionally mislead or the deck stacked.

[IdentityCrisisMama]

I'm jumping to help Mosaic and HHM to remind everyone to talk issues, not individuals. 

[kathymuggle]

Originally Posted by Rrrrrachel 

Sure, but you not getting the number you're interested in every single break down you want it in in the summary that has to fit on the insert and not even talking about the full study is not the same as being intentionally mislead or the deck stacked.

I read the link you posted, and my critique was of it:

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

Not parsing out the saline/AAHS does not give me the info I want.

As per the bolded, I did not say they intentionally mislead or stacked the deck.  I suspect they put the saline and AAHS together as the saline sample size was small.  None the less - putting AAHS and Saline together does affect the numbers, and it makes it difficult for me to say there was a "saline trial."  

It is possible the full study completely parses out AAHS and Saline (although I suspect it is doubtful as the saline sample size was small) but I will eat my words with a fork and knife if I am wrong 

Have you read the full clinical trials study and do you have a link?

Edited by kathymuggle - 11/18/12 at 6:39pm

[Rrrrrachel]

No, unfortunately I dont have an institutional log in that will let me access them. I just thought it was interesting that its said over and over around here that it was never tested with a true saline placebo, but it actually was.

[Taximom5]

Originally Posted by Rrrrrachel 

No, unfortunately I dont have an institutional log in that will let me access them. I just thought it was interesting that its said over and over around here that it was never tested with a true saline placebo, but it actually was.

Oh, for heaven's sake.

It was NOT tested against a true saline placebo.

It was tested against a combination of mostly AAHS "placebo" vaccines, with a very small number of true saline placebos thrown into the mix.

It was never tested against ONLY a true placebo. Neither was the AAHS "placebo."

And you now as well as I do that Merck would never allow the results for both placebos to be released individually., because the results would too obviously point to harmful effects from both Garasil and from e AAHS "placebo."

[Rrrrrachel]

Yes it was,taxi. The inserthas the breakdown for several adverse events with aahs and saline separated. Not all studies even used aahs as a control.

[Rrrrrachel]

And no aahs was not a placebo. It was a control.

[Taximom5]

They did not separate the incidence of systemic autoimmune disorder between saline, AAHS, and Gardasil.

Funny, they don't supply a breakdown for the severe side effect that is most likely caused by aluminum-adjuvanted vaccines, and NOT caused by saline.

Oh, wait, that's right, it's not funny at all, because they did it this way on purpose.

[Rrrrrachel]

They don't supply a breakdown in the insert. I'm not sure why that is. Have you read the full studies?

[Taximom5]

No. Have you?

Perhaps it would be more accurate to say that Merck has not publicized data specifically comparing ALL serious reactions to Gardasil vs AAHS vs true saline placebo/control.

Given their track record of hiding data that shows lower efficacy and/or higher rates of serious adverse reactions, it's probable that they've tested these things years ago and decided to hide all unacceptable results from any tests that they've conducted on Gardasil.

[Rrrrrachel]

I don't know that they haven't published those results, though, because I haven't seen the full study. Neither have you. Seems like a lot of jumping to conclusions.