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Good morning.
My name is Dr. Ina Park, and I'm the medical director of the California STD and *** Prevention Training Center,
and today I'm here to talk to you about the HPV vaccines and what providers need to know.
So first of all, I just want to point out to everyone that HPV really is everywhere.
The CDC recently updated its estimates of HPV in the United States, and I think you'll find them pretty surprising.
First, there are 14 million new infections of HPV per year, and that equates to, at any given time,
79-million people infected with HPV in the U.S.
Now, luckily, the vast majority of these infections are transient,
and about 90% of folks that have HPV will clear it within two years.
Now for those of us that don't clear our HPV, HPV becomes an unwelcome guest in your home,
and this is kind of like the guest that you can't get rid of and so they start messing up your kitchen,
they start ruining your furniture, and you can see what happens when HPV takes up residence in the anogenital tract.
So the first picture on the left is anogenital warts on the ***, followed by cervical pre-cancer, or CIN,
and finally with *** pre-cancer or AIN.
And if left long enough in the genital tract, then HPV can cause cancer, and about 35,000 people in the U.S.
will be inflicted with an HPV-related cancer in any given year,
and that equates to about $8 billion in associated health-care costs, so an incredibly devastating
and common infection with bad sequelae.
So luckily we have reason for celebration, because we have two FDA-approved HPV vaccines.
I'm going to tell you a little bit about both of them.
And the first that was approved was Merck's Gardasil, and that protects against Types 6, 11, 16, and 18,
and that prevents warts, cervical cancer, and *** cancers, and it's FDA approved for females
and males from the ages of 9 to 26.
Now it is expensive, and the cost is about $375 for the three-dose series.
Next approved was GlaxoSmithKline Cervarix vaccine, which protects against types 16 and 18
and prevents cervical cancer and was FDA approved for this purpose in females ages 10 to 25,
and is very similar in cost in terms of it's about $365 for the three-dose series.
So this data is just to illustrate that the HPV vaccines are both incredibly effective.
These are all data from randomized controlled trials that were published in the last six years or so,
looking at the efficacy of both the quadrivalent vaccine and the bivalent vaccine to prevent cervical pre-cancer,
genital warts, vulvar pre-cancer, genital warts in males, and *** intraepithelial neoplasia
or *** pre-cancer in males.
And you can see that it ranges anywhere from 78% for *** pre-cancer in males, up to 100% for genital warts
and vulvar pre-cancers, so, again, HPV vaccines, very, very highly effective, which is what led to their licensure
and approval.
So I just want to do this exercise, which is let's think about,
well what's the potential impact of these vaccines if we were to vaccinate everyone in the population
that was at risk for HPV.
We could eliminate 90% of the genital warts, about 80% of the *** cancers, 70% of the cervical cancers,
and 60% of the head and neck cancers.
So you can see that, potentially, if vaccinations were to reach many people in the population,
we would have a huge potential impact on HPV-related cancers in the U.S.
So now who should be vaccinated?
And I'm going to spend a few moments talking to you about the different folks of people for whom an HPV vaccine is
recommended, and that includes girls and young women, boys and young men, ***-positive men,
as well as men who have sex with men.
So the Advisory Committee on Immunization Practices, which is a CDC organization,
put out recommendations for vaccination in both males and females.
And for all females it's pretty straightforward,
and that is that females ages 9 to 26 should all be routinely vaccinated with either the quadrivalent
or the bivalent vaccine.
Now for all males it becomes a little bit more complicated.
So there is a recommendation for routine vaccination of males ages 9 to 21
for routine vaccination with a quadrivalent vaccine.
Now for ages 22 to 26, there is a permissive recommendation from the ACIP,
which means that you can give the vaccine but it's not a strong recommendation.
Now for MSM and for ***-positive men there is routine vaccination recommended up to age 26,
with a quadrivalent vaccine, and what this means,
when you see something that says "a routine vaccination recommendation,"
is that most insurance payers will pay for things that are routinely recommended by the ACIP.
And so we have two FDA-approved vaccines that are highly effective and recommended,
so how are we doing in terms of vaccine penetration in the population?
So as you can see from this graph, you'll see that,
in terms of the percentage of girls that have received one dose of the vaccine,
we have less than 60% from the years 2008 to 2011, and this is according to data from the National Immunization Survey.
And for girls who've completed all three of the recommended doses it's even worse,
because we have less than 40% of girls actually having completed the recommended three-dose series.
When we look at males, we see that less than 10% have actually received even just one dose of the HPV vaccine,
and so hopefully as we go on the data in males will become better.
So what gives here?
We have two approved vaccines that are recommended, that are highly effective,
and so why aren't people just running out in droves to get vaccinated?
And so I want to touch on some of the barriers that may be facing folks
and providers in terms of getting HPV vaccine into their patient population.
So I think whenever a new vaccine is released folks are concerned about whether or not it's safe,
and I think that goes for both parents and providers.
And so these are data, from 2011,
demonstrating the relative proportion of folks that have been affected by serious adverse events form the HPV vaccine.
So the large green circle is 35-million doses of Gardasil, which have been distributed since its licensure.
And then you will see that less than one tenth of one percent
have actually had any kind of side effects from the vaccine.
And then that tiny little green dot below represents people suffering serious side effects,
and that is less than one one-thousandth of one percent.
Finally, that tiny minuscule dot, that you probably can't even see,
represents folks that have died within a year of vaccination.
So out of 35-million folks that have been vaccinated, 68 have died within a year,
and that doesn't mean that that was attributable to the vaccine.
It's just temporally related, and so perhaps causally related.
But when those deaths have been investigated
and you look at the number of confirmed deaths related to the HPV vaccine, you will see that that is zero.
And so both the CDC and the FDA have come out with this statement to say that the CDC
and FDA have determined that Gardasil is safe for use in preventing HPV Type 6, 11, 16, and 18,
and Cervarix is safe to use in preventing HPV Types 16 and 18.
Another concern I think that many parents had when the HPV vaccine came out is that
if I give my child the HPV vaccine, are they going to go out and have all kinds of wild sex?
And someone actually did a study of this, which I think is awesome.
And the HPV vaccine does not increase promiscuity.
In fact, according to the National Survey of Family Growth,
HPV vaccination was actually associated with more consistent *** use,
so those girls and boys that were vaccinated were more likely to report consistent *** use;
in fact, three times more likely.
So HPV vaccination was not associated with being sexually active or having a higher number of *** partners.
So I think this can put parents' fears to rest, that giving folks a vaccine is going to make them go out
and do something unsafe.
Other providers who work with teenagers can sometimes be concerned that their clients
or patients want to consent for the vaccine without their parents knowing.
And in California, minors can actually consent for the HPV vaccination.
So according to Assembly Bill 499, it allows minors 12 years of age
or older to consent for medical care related to the prevention of STDs and ***,
so now that would include vaccinations such as the HPV vaccine.
And this is effective as of January 1st, 2012.
So I think now, as a provider, you might be asking,
"Well what can I do to improve HPV vaccination among my patients and in my practice?"
So I think, for yourself, it's very empowering as a provider to know the HPV recommendations
and to know the safety data,
and that way if someone approaches you and has concerns, you can counsel them effectively.
In terms of what to say to parents, it's important to recommend the vaccine, as well as counsel
and respond to parents' concerns about safety or increasing promiscuity or any of those things we discussed earlier.
And for your practice,
it's important to establish reminder systems to improve patient return rates for vaccination
and to reduce missed opportunities for vaccination,
if a patient shows up for some other reason unrelated to vaccination,
you want to capture them at the time that they show up.
And I just wanted to point out that providers are very powerful in this effort.
In the past calendar year alone there have been seven different articles published in these six peer review journals
that demonstrate that a provider's recommendation for a vaccination improves the likelihood of vaccination
by anywhere from 5 to 19 times.
And so I just wanted to summarize with four key messages that any provider can give to parents,
and the first of those is that HPV vaccine prevents cancer.
Now it also prevents genital warts, and it's fine to give that message too,
but I think parents know what cancer is and identify with it, and I think that message is very powerful.
The best time to give the HPV vaccine is before exposure, because we do know that once you are exposed to HPV,
getting the vaccine does not do you any good.
And then finally, vaccination is recommended for girls and boys, and then HPV vaccine is both safe and effective,
and I think that's probably one of the most powerful messages that you can give to a parent.
And if your patients are so inclined, after they get vaccinated, they may go out
and buy these HPV thong underwear online.
They really do exist.
They say, "I'm immune to HPV, yeah, baby."
But I just want to mention a final message to providers;
vaccinated women should still receive routine cervical cancer screening.
So they're not actually immune to the other types of HPV that can potentially cause cervical cancer.
So I just want to give you some parting words from the happy *** who says thank you so much for vaccinating,
and thank you very much for your attention.