Gardasil for Boys, link to FDA docs

[13Sandals]

Here is a link to all the docs for the Sept. 9 FDA meeting regarding Gardasil for boys:

http://www.fda.gov/AdvisoryCommittee.../ucm181365.htm

Special note is the 4th button down: Gardasil briefing document.

Most of you will remember that the Gardasil trials for girls had an aluminum containing placebo and a smaller group who received a saline-only placebo. For the safety study - the charts break out the mild side effects separately for the aluminum containing and saline placebo..the saline reactions are FAR lower than the aluminum or Gardasil groups. However, for major side effects and autoimmune disorders, they only provided a column for the combined reactions of Alum placebo and saline placebo. So we don't get to see where the major events come from - presumably, there are no major events from saline, so they don't want anyone to clearly see that.

You'll notice in the trials for boys - they don't even bother to break out the saline reactions for mild events. Its just called 'ALUM placebo'. A saline only placebo is only mentioned once in the whole doc - for the 'overall extent of exposure chart'. That is the only place in the whole document we can see the difference between gardasil and a true control group - and this particular chart has NOTHING to do with the safety.

Please someone, after all the flack over the alum containing placebos in the girl trials - WHY does the FDA allow this??? Please go to these docs - its a GREAT place to see why you have to read the fine print - which the media obviously does not bother to do.

[Maxsmom1]

FDA panel urges HPV vaccine be given to boys

Well we all knew it was coming....

http://www.cnn.com/2009/HEALTH/09/09...les/index.html

[13Sandals]

is it okay to bump your own thread?

now that the panel has recommended this (FDA almost sure to follow) thought some might like to read the docs on the 'safety studies'.


from the report:

Analysis of the most common systemic AE’s(adverse events) was similarly unremarkable. The case splits of systemic AE’s in the Gardasil group compared to the placebo group by system organ class (SOC) were similar.

of course, that 'placebo group' was pumped full of aluminum...

[Sileree]

$$$$$$$$$

[amnesiac]

merging these 2 threads.

[xmasbaby7]

I can't believe it. Of course I can BELIEVE it but it just seems so transparent. Perhaps it is another straw to weaken the camel's back.

[newmum35]

I just wonder what the ramifications of this will be down the line. With a lot of these vaccines they seem to create more problems than they help. I mean, with chicken pox for example, there's the shingles issue in adults... with the hib and prevnar, the serotype replacement, etc etc. Since they know this is only a few strains out of many, will this also be an issue of replacement and will the other strains become more aggressive or what will happen because of this if in fact it does successfully eliminate these few strains in most of the population. What other problems will be created as a result of "preventing" genital warts?

[claddaghmom]

Don't they have to combine them due to sample size?

[Pirogi]

Originally Posted by newmum35

What other problems will be created as a result of "preventing" genital warts?

... and cervical cancer.

Originally Posted by claddaghmom

Don't they have to combine them due to sample size?

Even if this were so, that would weaken the study further. A study with a sample size that is too small yields results that are very weak.

[13Sandals]

Originally Posted by claddaghmom

Don't they have to combine them due to sample size?

you mean the placebo groups for the 'safety' trials? well, if the FDA would limit placebo groups to actual placebos (saline only), then then they wouldn't have to worry about that. I know, I know, its argued that the efficacy part would theoretically allow an ALUM placebo - but that's no reason to short-change the safety trails.

[newmum35]

Originally Posted by Pirogi

... and cervical cancer.


Even if this were so, that would weaken the study further. A study with a sample size that is too small yields results that are very weak.

No, I meant "genital warts" and only that. They already give HPV to girls. Now, they want to give it to boys too and their selling point is that it will "prevent genital warts" and I have to wonder if whatever is going to happen down the road as a result of being vaxed is going to be much, much worse than having genital warts.

Not only the long term unknown effects, but just the short term ones alone... you know there are going to be healthy boys dying and having serious adverse effects from this vaccine (just as in the girls) ... is this really a risk worth taking to prevent genital warts?

[Romana]

I wonder if there are similar fainting/collapsing episodes in boys if they will keep insisting it's just because they're afraid of getting a shot.

[caned & able]

HPV is not the only cause of cervical cancer.

http://www.ehealthmd.com/library/cer...cc_causes.html

And the vaccine protects against only 4 of the over 80 HPV strains that cause cervical cancer. Iatrogenic DES exposure is also another cause of cervical cancer.

[claddaghmom]

Originally Posted by Pirogi

... and cervical cancer.



Even if this were so, that would weaken the study further. A study with a sample size that is too small yields results that are very weak.

Originally Posted by 13Sandals

you mean the placebo groups for the 'safety' trials? well, if the FDA would limit placebo groups to actual placebos (saline only), then then they wouldn't have to worry about that. I know, I know, its argued that the efficacy part would theoretically allow an ALUM placebo - but that's no reason to short-change the safety trails.

Well, I was just told that ethically the researchers had to combine the saline and alum numbers b/c the saline numbers were too small.

Of course, that still confuses me as to why they bothered to do the actual placebo group at all? Was it to get enough of a statistical skew on the numbers, to reduce the alum placebo results?

Sorry if these are off the wall questions...learning here...

[13Sandals]

Originally Posted by claddaghmom

Well, I was just told that ethically the researchers had to combine the saline and alum numbers b/c the saline numbers were too small.

the saline numbers can only be too small if Merck wants them to be too small
What's unethical is the FDA allowing Merck to run 'safety' trials without a clean control group, because injecting aluminum into the body has NEVER been evaluated for safety.

Of course, that still confuses me as to why they bothered to do the actual placebo group at all? Was it to get enough of a statistical skew on the numbers, to reduce the alum placebo results?

Yes, exactly!
vaccine vs. saline-only ...huge difference in adverse events, makes vaccine look scarier.
vaccine vs. aluminum placebo....smaller difference in adverse events, vaccine looks safe.

they only use a saline group so they can double-speak when called on the aluminum 'placebo' travesty and truthfully say, "But we did use a saline group!!" Again, how is the FDA looking out for the public here??