Humor me and read the following abstract of a study:
“Background The GARDASIL long-term follow-up (LTFU) study is an ongoing extension of a pivotal randomised, placebo-controlled, double-blind, 4-year study to investigate the safety, immunogenicity, and effectiveness of quadrivalent Human Papillomavirus vaccine (qHPV) on the incidence of HPV 16/18-related cervical intraepithelial neoplasia (CIN) 2 or worse in 16–23-year-old women (Protocol 015).
Methods Follow-up of subjects will be accomplished in two ways: (1) registry-based follow-up for effectiveness data as well as safety data including but not limited to deaths, cancer, and hospitalisations; (2) active follow-up for blood collection for immunogenicity assessments at years 5 and 10 of the LTFU study. Effectiveness and safety analyses will occur approximately 2 years following completion of Protocol 015 and approximately every 2 years thereafter for 10 years. The current report represents the first of these efficacy and safety analyses. Cohort 1 included approximately 2700 subjects who received qHPV vaccine at the start of Protocol 015. Cohort 2 consists of approximately 2100 subjects who received placebo at the start of Protocol 015 and qHPV vaccine prior to entry into the LTFU. Vaccine effectiveness against HPV 16/18-related CIN 2 or worse was estimated by calculating the expected incidence of CIN 2/3 or worse in an unvaccinated (placebo) cohort using historical registry data. The primary analysis approach was per-protocol.
Results There were 1080 subjects that contributed to the follow-up period out of a total of 2195 eligible subjects in the per-protocol population in Cohort 1. In these subjects there were no cases of HPV 16/18-related CIN 2 or worse observed. There were also no cases of HPV 6/11/16/18-related CIN, vulvar cancer, and vaginal cancer observed. However, the follow-up time in person-years is insufficient to make a definitive statement about the effectiveness of the qHPV vaccine for the current time period.
Conclusions The qHPV vaccine shows a trend of continued protection in women who were vaccinated up to 7 years previously, although there is as yet insufficient data to confirm that protection is maintained. The qHPV vaccine continues to be generally safe and well tolerated up to 6 years following vaccination.”
You can go ahead and re-read it if you didn’t quite catch something.
Now, please look at the conclusions. Women who were vaccinated with the HPV vaccine 7 years before this study were found to not have “cervical intraepithelial neoplasia” (an abnormal Pap smear) from the HPV strains 16 and/or 18. You agree, right? Well, you wouldn’t if you were a recent graduate of the master of public health program at George Washington University and a rabid anti-vaccine activist. He read the same abstract of this paper and he vehemently disagrees with what it states.
“No, we cannot confirm [that protection from the vaccine has lasted that long] based on this study. If you look in both the Results as well as the Implications and Impact in the abstract, it clearly says the data is insufficient.”
I am shaking my head at the level of ignorance of this young man, this “kid”. I sent his blog post to a couple of his teachers at GW, and they told me the same thing we all knew, or don’t know. We don’t know how the hell he got the degree, but we’re thankful he’s not planning on working for any public health agency any time soon. Personally, I’m sad for whatever poor sucker has to be his doctoral thesis advisor. I mean, if you can’t read an abstract (a bloody abstract!) and comprehend it because you focus like a laser beam on one statement within the abstract and not the whole, how are you going to read the body evidence for whatever thesis research you take on? (Kid, read the goddamned “methods” section where it is clearly explained to you, in plain English, that this is an LTFU, then STFU.)
Oh, I forget, you’re an anti-vaccine nut job. Evidence, and hard evidence at that, is one of those things that doesn’t exist in your universe. You want to know why the conclusions state that “there is as yet insufficient data to confirm that protection is maintained”? It’s not because protection is not maintained, kid. It’s because these women are between the ages of 16 and 23, so they have not left the age group at most risk for cervical hyperplasias/neoplasias (i.e. positive Pap smears). Until all of those women vaccinated in their teen years are out of the “danger zone”, so to speak, we rational people of rational and comprehensive knowledge of public health in general and epidemiology in particular cannot say that the vaccine worked at 100%.
It’s like giving people the flu vaccine in September and then saying it’s October and no one has died from it and they all have strong antibodies against the flu. The vaccine is safe and effective, but we can’t go saying that it’s a complete success until the end of the flu season in May of the following year. You know this, kid! You studied effin’ epidemiology! You would probably say that the vaccine is crap even before the flu season starts.
The HPV vaccine is a fairly new vaccine as far as vaccines go, and it’s going to take some time for all those women to get through that age where most women come down with abnormal pap smears or cancer (or genital warts) due to the strains of HPV for which the vaccine is protective. It will take a little more after that to declare victory. The median age for cervical cancer diagnosis is 48 years. Rarely do women under the age of 20 get abnormal Pap smears because the processes by which HPV leads to lesions or worse takes time. (Knowing the kid, he probably doesn’t know what median is and is confusing it with mean and has not read up the prevailing evidence on cervical hyperplasias/neoplasias.) I mean, look at what he wrote later:
“For Sanofi Pasteur MSD to quote her and use her study in the press release to claim her research shows Gardasil protects against HPV infection for eight years when her own study said the data was insufficient to show that protection is even maintained for seven years is a misleading representation of trial data to promote a product.”
The “her” in his statements is one Dr. Susanne Krüger Kjær from the Danish Cancer Society, and the research seems solid since it’s a cohort study several thousand participant strong. Even if we gave them the vaccine right now and told these young women to go have unprotected sex like bunnies do (and, trust me, bunnies do), it would take a while for them to become infected and develop warts then get rid of the warts and develop abnormalities in their cervices. We’re talking years, not weeks or months like is the case with other vaccine-preventable infections. It’s all in the prior knowledge about HPV and what it does, and it’s something that the kid needs to understand if he is to be successful in his aspirations to get a PhD in epidemiology. (God help us all if that ever happens, though he probably won’t use it for good and just go dumpster diving into pre-existing data, torturing the data until it tells him what he wants to hear.)
The kid’s childish rant is because a press release by Sanofi Pasteur (a vaccine manufacturer) quotes three abstracts of yet-to-be-published research on Gardasil, a vaccine made by Merck. (Sanofi-Aventis and Merck both co-own Sanofi Pasteur, which markets Gardasil to countries outside the US of A.) The kid doesn’t want vaccine manufacturers to toot their own horn, even though the manufacturers are doing nothing more than pointing us, the consumer, to independent research on their product.
If we were talking cars, the kid probably wouldn’t want Ford, Chrysler, or Toyota to point to research from the Insurance Institute for Highway Safety on how safe their cars are. If he were afraid of flying, Boeing and AirBus probably wouldn’t be able to say that they’ve gone X many days without a serious crash. He’d probably want them to go another X number of years before they can be conclusive about their safety. Because it’s vaccine-related, he seems to not want a vaccine maker to point to the safety of its own product.
And why not? Sanofi Pasteur is not pointing to its own research or research it sponsored. (As far as I can tell, they didn’t sponsor the research since there is nothing noting that very obvious conflict of interest in the abstracts of the research papers. There’s always a chance the Illuminati had something to do with it.) It’s just that the kid, being the anti-vaccine activist that he is, one that goes as far as
stalking randomly being in the same room where people who speak for vaccines are, probably doesn’t like seeing that thousands of women are abnormal Pap smear-free and cancer-free eight years after the HPV vaccine. He probably wishes they all die soon so his apprehensions about vaccines, his monsters under his bed, all come alive and he can be some sort of a hero to his people, the same people that have shunned him.
But Jacob Lawrence Crosby, aka Jake Crosby, aka “the Kid”, anti-vaccine believer, does not seem to want to analyze critically anything that puts vaccines in a good light. If it’s some sort of baseless accusation of the horrors of the HPV vaccine, I’m sure he squeezes every little bit out of it. Just read his blog, for God’s sakes. Anything is caused by vaccines, there is a great conspiracy based on spurious associations between many people, and anyone who criticizes him is a bigot or a paid pharma shill. Anything he doesn’t like is immediately branded defective instead of countering it with evidence to support his claims. Anything he does like is raised to the highest echelons of “evidence”.
But not this, not something that, if anything, lets his demons sleep a little longer by keeping women safe from harm.
(I write out Jacob’s name in violation of my rules because I’ve been noticing new visitors to the blog and I don’t have time to explain why he’s the kid or who he is. It’s just this once, for now.)