Discussion on HPV Vaccine and Health Risks

So please welcome Christina's mother, Emily Tarsell.

Thank you so much for being here.

First of all,

I'm so sorry about your, your daughter's death.

Thank you.

Just 21 years old. Tell us a little bit about Christina,

Emily.

She had a great curiosity about life.

She was an athlete and an artist and a philosopher.

Sounds like an outstanding person with obviously an incredibly bright

future.

Right.

Did you all decide together that she would get the HPV vaccine?

When she was 20, we went to see the GYN for her

first visit. Um, the doctor was telling us that

Gardasil would be safe and effective, would prevent cervical

cancer.

Let's talk about-

Mm

... Christina's experience. I know that

she had symptoms after each shot was administered.

What were those symptoms?

Well, because we have a case pending, I cannot go into

detail about which ha- what happened each, each time.

Um, she was previously healthy, had no existing

conditions,

um, but did, did begin to develop some things.

You know,

"Oh, I have a rash. Hmm, wonder what that's about.

Um,

I feel fatigue. I feel dizzy." And she

reported this within a few days of her

third shot,

and within 18 days, uh, of the Gardasil shot, she was found

dead in her bed.

When was the last time that you saw your daughter?

She was going back to Bard to

be trained for a job that she'd have there on campus during the

summer.

So I hugged her

and,

and I can still feel,

feel that embrace, and

I let her go,

uh, and,

and that was the last time I saw her.

You have, I know-

But-

... filed a federal claim because Gardasil

was approved by the FDA.

Why did you decide you were going to do that?

If you have reason to believe your daughter died and

from, from a product, uh, that caused her death,

you, you want to hold people accountable.

Well, we reached out to Merck, the manufacturer of Gardasil, and in a

statement, the company defended the vaccine, saying,

"Its safety

was established in clinical trials involving more than

25,000 females and males. They continued studying

more than 500,000 people after more than a million doses had

been administered." And the statement went on to say,

"Parents should

understand the extensive data supporting the safety profile

of Gardasil, and we encourage them to look to the CDC

and

FDA and to the advice of their own physicians to make an

informed choice about something as important as a vaccine to help

prevent cervical cancer."

Dr. Diane Harper is a professor at the

University of Louisville and an

international expert on HPV and HPV prevention.

I know, Dr. Harper, you were an integral part of the science of

bringing the

HPV vaccine into human trials. So

why initially did you think this was such a positive development for

cancer prevention?

Um, I was very excited initially because I

thought, "Yay, we have

a vaccine. This could be really important, especially in countries that don't have

any screening with it." But then I started looking at what isn't

covered, and I

looked at the fact that Gardasil doesn't last long enough to

prevent cervical cancer, and HPV infections are something women

continue to get throughout their lifetime.

The other thing that, in looking through CDC data as well

as other published data, is that HPV is most

often sexually transmitted, but between the age of birth and

11 years of age, 10 to 15% of these children are

already infected with these high-risk types.

So it isn't that you're completely negative until you're 11 years of

age, and then you're at risk, so there is an underlying infection rate

already that's there. So that makes it-

From not being s- uh, it's not from sexual activity-

It's not

... it's just because they have the virus.

There's some kind of cutaneous transmission.

It's always skin-to-skin transmission, and there's some kind of cutaneous

transmission, whether that's parental, whether that's babysitter, whether that's

bathtub, we don't know.

So are you saying that you would now not recommend

girls

or boys get the HPV vaccine?

In the concept of cervical cancer prevention, what I think is

important for people to know is that Gardasil is an option,

but that's all it is, is an option, and if you feel comfortable

that you want to take the vaccine to prevent yourself

from getting an infection for a certain amount of time, that is

your right to do. That is the benefit of taking

Gardasil, is that will happen, but as we've heard, there are also

some harms associated with it.

In your expert opinion, do the benefits outweigh the

risks?

We have Pap screening now in our new recommendations that just

came out a couple of months ago that use HPV testing

and cytology together, and those-

What's cytology? Sorry.

I'm sorry. Pap smears, cells, right.

When you go in, you get those cells scraped-

Right

... off your cervix. Um, we put those two tests together.

We have nearly 100% ability to find

pre-cancers, which can be treated at 100% cure rate,

um, and they can detect cancers. It's a much better Pap test than the one

we've had

in the past, which has not been able to detect all the

cancers, even if you

get them. So at this point, what I think that is most important for

people to understand is that Pap screening is key.

Pap screening is key to all of this.

Um, if you get the vaccine, you still have to come in for Pap

screening

because of the other HPV types that could be causing changes

in your cervix.

And with boys, uh, boys can get a number of

cancers if they have the HPV virus,

correct?

Correct. The kinds of cancers that boys can get are

anal cancer and head and neck cancer are the two,

penile cancer. All three of those cancers

occur in very low rates. NIH defines

those as rare diseases. The only exception to

that is in men who have sex with men, and in that

population, the rate of anal cancer is just as high as the rate of

cervical cancer before we had Pap testing.

But in boys, again, the efficacy is no more.

The trials lasted three years, so the long duration of

protection, if you're vaccinating somebody at 13,

may not last long

enough.

I had no idea that it only lasted for five years.

I thought it was a lifetime, uh, protection,

knowing that still Pap smears were necessary, but I didn't

realize the efficacy basically wore off after five years.

That's correct.

So when you hear about this, Emily, and you hear Dr.

Harper

say these things, how does it make you feel?

Well, it is the reason I'm here, because it's an outrage,

so that's why you have to know, and you have to take

responsibility for finding out.

Well, Emily, thank you for, for coming and talking to us about this

important topic, about your daughter, Christina, and I know it's,

must be very painful for you to do that.

But we appreciate

your being here and telling us your story and her story. And, and Dr.

Harper, thank, thanks to you as well.