The New England Journal of Medicine's editorial at the link below took an in depth look at the clinical trial data on Gardasil and determined that the vaccine has only "modest" efficacy.

http://content.nejm.org/cgi/content/full/356/19/1991

What the general public does not know in order to make an informed consent is that Gardasil was never tested to prevent cancer. It may be hyped as the first vaccine to prevent cancer but there is no proof to date that it can do this. The clinical trials tested the vaccine for efficacy on precancerous lesions. Because these lesions can take 8 to 12 years or longer to develop into cancer and the clinical trials lasted less than 5 years, it is unethical to say this vaccine prevents cancer. Also, by saying this, the public is denied the ability to make an informed consent.

Pam Martens

Pam

Did you not read the article you posted the link to? Or did you deliberately distort what the author reported.

Another selective quote from either a fool or a liar. Please read the report again, then read your post. Then apologise.

Disgraceful.

Interesting NEJM article, Pam, but in these trials the “modest effect” of the vaccine in preventing CIN was seen in women the vast majority of whom were already sexually active. In women with no evidence of previous exposure to HPV 16 and 18 there was “efficacy of nearly 100% against all grades of cervical intraepithelial neoplasia and adenocarcinoma in situ related to vaccine HPV types”. Which is why there’s a push to vaccinate girls before they become sexually active, not after.

The caveat, though lies in the “related to vaccine HPV types”. The question is, will this lead to an increase in CIN and adenocarcinoma in situ (and invasive cervical cancer) from non-16, non-18 HPV types? Plausibly, a reduction in type 16 and 18 disease might leave room for other cancer causing HPV types, which would reduce the overall effectiveness of the vaccine in preventing invasive disease.

Sir Vivor, I’m not exactly certain of the difference between “detailed safety follow-up” and “serious adverse experiences in medical history and pregnancy follow-up”. I assume the first means a structured interview of the trial participant, while the second means combing the written medical record and adverse event notifications. Don’t quote me, though.

Re what events were rare or serious, this page gives details of the trial data including a breakdown of adverse events.:

http://72.14.235.104/search?q=cache:8_Jv7zhsez0J:www.pbm.va.gov/monograph/Gardasil.pdf+21,464+subjects+trial&hl=en&ct=clnk&cd=2&gl=au

The judicialwatch site http://www.judicialwatch.org/6299.shtml also links to PDF copies of every post marketing adverse event report. I haven’t checked all 1637 of them, but a few things are clear:

Most of the vaccine related events were soreness, mild rashes, poor management of anxiety about having a shot, and vasovagal reactions common to all needles including venepunctures. US doctors need to redesign their couches so their patients stop falling off them. Not much of a catch for the plaintive lawyers’ fishing expedition.

The one type of genuinely serious event apparently caused by vaccination was Guillain Barre syndrome, a rare neurological complication of some infections and vaccinations. However these reports seem to put meningococcal vaccine given at the same time in the frame, not the HPV4 shot.

Here is how the Nuremberg Code defines informed consent pertaining to medical experiments:

"The voluntary consent of the human
subject is absolutely essential. This means
that the person involved should have legal
capacity to give consent; should be so
situated as to be able to exercise free power
of choice, without the intervention of any
element of force, fraud, deceit, duress,
overreaching, or other ulterior form of
constraint or coercion; and should have
sufficient knowledge and comprehension of the
elements of the subject matter involved as to
enable him to make an understanding and
enlightened decision."

Does the public know the following or has it been intentionally submerged by an intense marketing and public relations campaign by Merck:

1. Gardasil was never tested for efficacy on 11 and 12 year old girls.
There is no proof this vaccine will work in preventing cervical cancer among this age population because the drug was never tested for efficacy on this age population.

2. There is no proof Gardasil is safe for this population because it was tested for safety among just a few hundred girls in this age population.

To most rational minds, if you have an unproven drug with unknown safety issues among a specific age population, you have an experimental drug and for a parent to give informed consent, they must be told all of the above, including that this is an experimental drug for this age population.

Pam Martens

WOW people are finally learning how to debate each other. Good job people.

Maybe there is hope yet.

The central issue in all this is Informed Consent, which I raised in post #14. The questions of how extensive are the side-effects, and is this vaccine effective, will be debated for some years as the evidence begins to come in.
As a society we must answer the question: is Informed Consent a primary principle to uphold, or is it window dressing to be applied in some situations only?
Pam Martens, in recent post, makes the most telling and central point with: "... if you have an unproven drug with unknown safety issues among a specific age population, you have an experimental drug and for a parent to give informed consent, they must be told all of the above, including that this is an experimental drug for this age population."
Unfortunately many of those attacking posters who are critical of the Gardasil process display a kind of blind faith, religio/scientific fervour that smacks of 'Thou shalt never question vaccines - they are all wonderful in any situation at all times'.
Vaccines, like any medical intervention should be subject to the most rigorous testing and ongoing monitoring. The authors of this essay have pointed out that Gardasil fast tracked that rigorous testing. It will be many years before we have reasonable data to know how Gardasil's cost/benefit equation stacks up. Till that time it must be treated as experimental, and Informed Consent must be honoured - including the "informed" part