Can anyone who supports the Gardasil vaccine speak to this issue? I have been looking in vain for answers while trying to decide whether to have my 13 year old vaccinated. Her pediatrician has been recommending it for 3 years already and I have held off primarily because my daughter is terrified of shots and I felt confident that I wasn’t anywhere close to her being sexually active. I am as concerned about the possible need for booster shots when she reaches the age of 21 when she is more likely to be sexually active than throughout the next 7 years as well as currently needing 3 rounds of shots now. I am also concerned about more aggressive and immune resistant forms of the virus as well as substitution of other forms of HPV as the agents of cervical cancer. Do we have real world data about the effectiveness of the vaccine since it was introduced? Shouldn’t the initial vaccinated populations be in their early to mid-20′s by now?

I just came across the words “Andrew Wakefield” in this Editorial:

http://www.ecomed.org.uk/publications/the-health-hazards-of-disease-prevention/403

Now imagine yourself as a trusting 13 year old. You look at your mumm and she advises you that the HPV is safe. The medical professionals, the government and the manufacturers say so in their very sparse literature but clever marketed strategy. It’s going to save your life. You are not going to get Cervical Cancer if you take this vaccine. (SCARE TACTICS).

So you are 13, you like sports, you play sports: football, cycling, tennis, basketball, bowling, dancing, jogging, mucking around, play fighting, walking, normal teenage stuff. You also don’t want to die of Cervical Cancer. No one does.

Then you get the shot. You are sick, dizzy, have a headache, sore arm. A month later (a relatively short space of time to notice a reaction), you get the second shot. Again you are sick, dizzy, have more headaches, your arm aches. The symptoms don’t go away. In fact they get worse. Your 13 you don’t feel like yourself, you don’t what’s wrong with your body, your not able to communicate to your parents that you feel different. You start feeling stiff, and get stiffer.

Then you parents notice the expected side-effects have not gone away. You are acting oddly but you can’t tell them what is wrong beause you don’t know yourself.

Then you find your body racked in pain, every muscle and joint aches. Your sick, you can’t eat, your tired. Your 13 lying in a sick bed. You can’t walk, you have no energy. You don’t go to school. You have string upon string of unexplained illnesses that the doctors can’t fix. The very people the leaflet says to go to if you suffer a side-effect – they can’t fix you.

You are 13 and you are scared. What’s happening mummy?

2 Andrew G. Ostor, International Journal of Gynecological Pathology 12, 186 (1993).

Sounds rather authoritative, but is an cherry picked quote that misrepresents what the study said by substituting in higher grade lesions in for the figures found by the author for CIN1. As Ostor noted himself, testing can become treatment as biopsies can alter the course of events either by obliterating a very small lesion or causing an inflammatory response and also that it’s impossible to predict whether a lesion will progress or regress just from looking at it. It’s very likely these figures are an underestimate, as other studies in the 1950-60′s into Carcinoma in Situ and it’s progression to cancer found this happened at least 30% of the time (studies ranged in length from 1-23 years). At least a third of women having the condition become invasive cancer is significant, and it’s simply wrong to suggest that progression is so rare that you can ignore the whole thing. Ostor’s study stopped at CIN3 as it’s unethical to sit there and watch study participants develop cancer just so you know how often it happens, particularly when the condition is very treatable at an earlier stage. Actually, that’s the same for the vaccine and for – using the endpoint of high grade lesion is sufficient, given you know a significant number will go on to develop cancer. Early prevention/treatment whether with a vaccine or a smear to detect the lesion earlier saves a lot of morbidity and mortality down the track.

Here’s what the author says: “The literature dealing with the natural history of cervical intraepithelial neoplasia (CIN) since 1950 is reviewed, in particular from the viewpoint of regression, persistence, and progression. When stratified into the various grades of severity, the composite data indicate the approximate likelihood of regression of CIN 1 is 60%, persistence 30%, progression to CIN 3 10%, and progression to invasion 1%. The corresponding approximations for CIN 2 are 40%, 40%, 20%, and 5%, respectively. The likelihood of CIN 3 regressing is 33% and progressing to invasion greater than 12%. It is obvious from the above figures that the probability of an atypical epithelium becoming invasive increases with the severity of the atypia, but does not occur in every case. Even the higher degrees of atypia may regress in a significant proportion of cases. As morphology by itself does not predict which lesion will progress or regress, future efforts should seek factors other than morphological to determine the prognosis in individual patients.”

As a matter of fact, “there is, as yet, no direct scientific proof of the effect of the vaccine on morbidity and mortality, and it will take significant time and resources to obtain such evidence.”

All the rest is vaccination policy, funding, marketing, politics and ethics.

Now you are confusing your uncorroborated attempts to smear the authors of this HPV vaccine study under discussion with accusations of fraud with the “bigger picture” of vaccination policy, funding, marketing, politics and ethics.

There is a lot to say about these, much of it contentious and some of it bad, but nothing which detracts from the efficacy of the vaccine. If you wish to broaden the debate into these multiple areas, feel free, but I’d rather stick to the subject under discussion than see people introducing straw men into the debate.

First, the adverse event rate for this vaccine is being calculated against number of doses shipped, rather than number of doses administered. What that means is that if the manufacturer ships two million doses, but only two are administered and both of those patients have adverse reactions, the true adverse event rate is 100% but it is being “officially” calculated as 1 in 1 million. If health officials think the vaccine has such a good safety profile, why the statistical charade?

Second, in the original clinical trials for Gardasil it was found that the vaccine had a NEGATIVE efficacy of over 44% in women who had already been exposed to the strains of HPV found in the vaccine. That means they had 44% higher risk of developing cervical abnormalities. (See the FDA meeting document here: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf ). Public health officials “solved” this problem by mandating the vaccine for younger children before they become sexually active, despite the vaccine not being adequately studied in that population and ignoring evidence that HPV can be transmitted maternally and those children may already have been exposed despite never having sex. Currently there is NO HPV testing mandated before vaccination. This is a ridiculous risk that should be mitigated but it won’t be due to cost and the confusion is might create over the relative benefits (or lack thereof) of this vaccine. It’s no wonder the public has lost trust over this issue.