Monday, August 17, 2009
Controversy surrounding the human papillomavirus vaccine continues as parents consider whether or not their young daughters should receive it. We speak with a pediatrician about the latest research on the vaccine.
MAUREEN CAVANAUGH(Host): I'm Maureen Cavanaugh. You're listening to These Days on KPBS. A vaccine that reduces a girl's risk of developing cervical cancer later in life was announced several years ago with much fanfare. It was a major breakthrough, a step forward in the ongoing battle against disease, and it held the promise of more advances in fighting cancers linked to viruses. Fast forward to the present, and now the major breakthrough has turned into a major controversy. The CDC recommends the vaccine Gardisil be given to girls age 11 or 12, but many parents are objecting. Their reasons range from concerns about adverse reactions to questions about the morality of inoculating young girls against a sexually transmitted disease. There's a lot of confusion about Gardisil the HPV vaccine and lots of chatter on the internet. With me to discuss the controversy is my guest, Dr. Karen Loper, an Associate Clinical Professor of Pediatrics and part of the Division of Adolescent Medicine at UCSD Medical Center. Dr. Loper, welcome to These Days.
DR. LOPER: Thank you.
CAVANAUGH: And we’d like our listeners to join the conversation. Have you been thinking about giving your daughter this vaccine? Or maybe you've decided not to. What are your thoughts and concerns? Give us a call about the Gardisil vaccine. Our number is 1-888-895-5727, that's 1-888-895-KPBS. Dr. Loper, you deal with patients and their parents on a daily basis who are thinking about giving their daughters the HPV vaccine. What have you seen in your practice?
DR. LOPER: I've seen a wide range of opinions and a whole lot of questions about the vaccine but, in general, once most families have been educated about how the vaccine is made and the benefits that come from it, I'd say the large majority of my patients have chosen to receive the vaccine.
CAVANAUGH: What are some of the things you've heard from parents?
DR. LOPER: The – One of the main questions is why have we chosen to give the vaccine at such an early age when most parents don't anticipate that their girls are going to be engaging in any sort of sexual activity until quite a bit later. And, you know, to – I guess to answer that question, I would say that the goal of the vaccine is to have all three shots established in the body and immunity established long before a young person would ever be exposed to the HPV infection.
CAVANAUGH: Let's go back and talk about the HPV infection and how people get it and what it causes.
DR. LOPER: Okay, so HPV stands for human papilloma virus and it is a viral infection that's mainly transmitted through sexual activity and that doesn't just mean intercourse. It can mean other sexual activity where bodily fluids are exchanged. It can cause genital warts and, later in life, it's been implicated in multiple cancers, cervical cancer being the main one but there are other cancers that it can cause as well, including anal, vulvar, vaginal and even oral- pharyngeal cancers as well.
CAVANAUGH: And are most sexually active people exposed to this virus at one time or another?
DR. LOPER: Yes, most sexually active people, at some point in their life, will be infected with one or more strains of HPV and the vast majority of them will actually clear the virus on their own and not have any serious consequences of it.
CAVANAUGH: Now, the vaccine has been around for about three years now. Tell me why the medical community feels this is so important.
DR. LOPER: Well, this is – this is only – They say the first vaccine that prevents cancer but actually hepatitis B is a vaccine that prevents liver cancers so it's really the second vaccine that prevents a cancer. But it's the first of what will hopefully be a series of vaccines that prevent viral infections that can cause terrible diseases.
CAVANAUGH: And, of course, it can also stop the risk of many young girls having – getting cervical cancer in their lifetime.
DR. LOPER: Absolutely. There's 12,000 cases of cervical cancer every year in the United States and 4,000 deaths from cervical cancer every year in the United States. So it's a significant disease.
CAVANAUGH: I'm speaking with Dr. Karen Loper. She is Associate Clinical Professor of Pediatrics and also part of the Division of Adolescent Medicine at UCSD Medical Center. We're talking about the HPV vaccine Gardasil and why there's confusion about it, why some people are not going along with the CDC recommendation that their girls be given the vaccine at age 11 or 12. We're taking your calls at 1-888-895-5727. What kind of symptoms do people have when they're infected with HPV?
DR. LOPER: Most people that have HPV will not have any symptoms but there are some strains associated with visible and palpable genital warts and actually two of the four strains that the Gardasil vaccine protects against are 6 and 11, which are implicated in 90% of the cases of genital warts. But HPV itself may really be silent.
CAVANAUGH: And, as you said, this vaccine doesn't prevent all strains of HPV, is that correct?
DR. LOPER: That's correct. It protects against four strains; 6 and 11 are implicated in genital warts and 16 and 18 are the two most commonly associated with cancers.
CAVANAUGH: Now isn't there some actual controversy on how long this vaccine will last? Isn't that one of the reasons that people balk at the 11 and 12 year old recommendation for the CDC? How long does the Gardasil last and provide that protection against HPV?
DR. LOPER: Well, because the vaccine is – hasn't been around long enough to be able to determine if immunity is lifelong, we have to go with what we know and what we know so far is that the early studies of vaccine efficacy have shown that at five years, 100% efficacy rates have been established so far. And because the vaccine is made similarly to other vaccines like hepatitis B, which is actually given in the infant years, one would think that it should be years and years and years or lifelong.
CAVANAUGH: And to be clear, this isn't just one vaccine that a young girl has to take.
DR. LOPER: Correct. There's three vacc – three – three vaccinations. There's shot one at time zero, shot two preferably two months later, and shot three six months after the first and at least three or four months after the second.
CAVANAUGH: Now I've been saying the CDC recommends that young girls 11 and 12 get it. Who can and who can't get this vaccine? In other words, when does it become basically useless for someone to get the HPV vaccine?
DR. LOPER: Well, the vaccine currently is approved in females aged nine to 26. That's the study population that it's been shown to be safe and effective for. They're currently doing more studies to be able to give the vaccine to older women. There's a study right now going from 27 to 55, and they're also doing a study in boys, as well, in a similar age group to the girls to hopefully prevent some of the anal/rectal cancers and penile cancers that can affect males.
CAVANAUGH: Let's take a phone call. We are taking your calls at 1-888-895-5727. My guest is Dr. Karen Loper. Let's take a call from Dave in Mission Valley. Good morning, Dave. Welcome to These Days.
DAVE (Caller, Mission Valley): Good morning, and I think your guest just answered both of my questions. I was going to ask why we aren't also giving the vaccine to males because they're – they would obviously be carriers of the virus and also can be affected by the genital warts, and whether or not it was also useful for older women or men to receive the vaccine. And I can take any comments off the air.
CAVANAUGH: Okay, thank you, Dave. Can you explain a little bit more to us why boys aren't being – recommended that they get the vaccination?
DR. LOPER: I think the target was really to prevent cervical cancer and – because that's the most prominent of the HPV-related diseases. But boys, indeed, are affected with much lower rates but anal/rectal cancers, penile cancers. And certainly the oral pharyngeal cancers affect both sexes. You know, they couldn't study everybody all at the same time. They had to start somewhere so I think they chose the most prominent population that was affected by HPV. HPV is largely in older teens, 20s and – older teens and 20s and that's the population they chose to start with.
CAVANAUGH: And, you know, it's interesting, so what you're saying is it may – Gardasil could very well be a preventative for some kinds of HPV or cancers down the road for boys but it hasn't really been studied in boys and so therefore it's not being recommended at this time.
DR. LOPER: Correct.
CAVANAUGH: Oh, okay, I got it. Let's take another call at 1-888-895-5727, that's our number. And I want to speak with Linda in Point Loma. Good morning, Linda. Welcome to These Days.
LINDA (Caller, Point Loma): Hi. Good morning.
LINDA: I have found that for myself and my family, all of the vaccines have different, you know, questions to weigh but this one is kind of a no-brainer for me and my family with the risks, you know, the suggested deaths associated from the vaccine and with the, you know, potential cancer deaths being, you know, way, way further down in life. For my daughter, there are like a few other reasons that she would have to use protection anyway, you know, like HIV and pregnancy and a lot of other things so I can't see where there would be any value to that vaccine with the risks involved.
CAVANAUGH: Well, you said a couple of provocative things, Linda, that I want to speak with the doctor about. First of all, deaths. Linda mentioned deaths from the vaccine. What do we know about that?
DR. LOPER: Well, we do know that there is a list of associated side effects to the vaccine that most of which are local pain, swelling, redness, irritation. There can be some nausea and vomiting. Fevers have been demonstrated. And fainting, dizziness and fainting have been shown. Now anytime anything negative happens following administration of a vaccine, it is reported to the VARs program, that's the Vaccine Adverse Reaction branch of the CDC. And so, you know, there may have been reports of deaths following administration of the vaccine but so far they haven't connected the deaths directly to the administration of the vaccine so we don't know at this time whether there have been any deaths directly linked to the administration of the vaccine. Just because something happens after something doesn't necessarily mean that it caused it. And at this time, the CDC certainly hasn't received any information that would make it want to pull the vaccine because of safety issues at all.
CAVANAUGH: So there's no causal link between Gardasil and any subsequent deaths or serious medical reaction?
DR. LOPER: Correct. The main – Well, the main serious medical consequence – Any time anybody faints, there's a chance that you could hit the floor and hit your head and…
DR. LOPER: …sometimes there can be shaking involved and…
DR. LOPER: …you know, the fear that there could be seizure activity. That can happen with any vaccine. But basically any time you put a needle in the body, there can be a vasovagal, what we call a vasovagal reaction and that can sort of change the way the blood circulates and make the brain go without oxygen for a brief moment and make you hit the floor. Some of the reports have shown that there seems to be more dizziness and syncope associated with the Gardasil vaccine. It's not clear if there's something unique about the vaccine that causes that or if it's just because of the patient population that we're giving it to. Girls are more likely to get dizzy and pass out following any vaccine.
DR. LOPER: So if you're only studying young girls, there's, I think, clearly going to be a higher rate of dizziness and syncope with that particular vaccine.
CAVANAUGH: And Linda's other point was that she's teaching her daughters to follow safe sex practices and use protection. Will that protect against HPV?
DR. LOPER: It's a really great point. I think, you know, the HPV infection is transmitted through mucosal contact that may happen outside the boundaries of a condom and, you know, condoms themselves are obviously the best thing we have to protect against most sexually transmitted infections but they're not a hundred percent. They break, they leak, they fall off, they get forgotten. And even with a condom used appropriately, there's always a chance that the virus can spread around it.
CAVANAUGH: I'm talking with Dr. Karen Loper. We are talking about the – Gardasil and the recommendation by the CDC that young girls 11 or 12 get a vaccine, the Gardasil vaccine against HPV and with the hopes that they will not develop certain kinds of cervical cancer later in life and other complications of the HPV virus. We're talking – We are taking your calls at 1-888-895-5727. You know, Doctor, I did a little looking into this, you know, the kinds of research that a parent might do on the internet and one of the doctors who helped in the clinical testing of this was a woman by the name of Dr. Diane Harper and she's become something of a touchstone for people who think – who don't want to have their daughters vaccinated. She's talked to the media about her concerns that not enough young girls, 11, 12 year olds, were included in the study and we don't know what the long term effects of this vaccine may be. And so I'm wondering if you hear that from parents, that kind of concern about the health risks down the road, how many young girls were included in the original study, and what you tell them when they come to you and they say this, you know, I don't want my daughter vaccinated because of these reasons.
DR. LOPER: I think it's a legitimate concern when anything comes out that's brand new and, I mean, I admit my advice to families is now very different than it was three years ago when the vaccine first came out. I don't necessarily want my patients to be the first for anything unless it's something really critical. However, now it's been three years, the vaccine has been given to thousands and thousands and thousands of girls and the vaccine is very much like many other vaccines that we've been giving our children for decades. It's – There are no components of this vaccine that are any sort of surprise. It's created using recombinant technology that's been used for other vaccines safely and it's in an aluminum-based adjuvant that's also been used in the past safely. The vaccine itself does not contain any life virus so there's no chance of any infection from it. If you understand how it's made, you know, I certainly, you know, in advising my patients, feel confident now that, you know, the initial clinical trials were shown to have enough to prove to the FDA – They basically allowed the FDA to approve it without any reservations and even more so now three years later that it's been given to thousands and thousands of girls. I feel confident recommending it and I support the CDC's recommendations.
CAVANAUGH: What about parents who think inoculating a 12-year-old against a sexually transmitted disease is just – they don't feel right about it. They don't – they think that it may encourage sexual activity at a – at an early age. Do you have discussions with patients about that?
DR. LOPER: Frequently. Yeah, it's an interesting philosophical question and, you know, there's no right or wrong answer to it. And every family really has to make their own decision, you know, about how and when they want to give the vaccine. I – You know, my personal views is that I – I don't believe that prevention incites risky behavior. I don't think that birth control causes young people to have sex. I don't think availability of condom causes people to have sex. I don't believe giving a vaccine to prevent cancer down the road is going to free up the mind of a young person to say, well, now that I'm not going to get cancer, I'm going to go run out and have sex. And I think that's been shown in various social science studies that, you know, kids live in the moment and I think, you know, they're going to do what they're going to do regardless of the protective measures that the adults have taken around them.
CAVANAUGH: So that's a pretty comprehensive answer you give those parents. Let me go to the phones once again and let's welcome Linda in San Diego. Good morning, Linda. Welcome to These Days.
LINDA (Caller, San Diego): Hi. Good morning.
LINDA: I'm a female, I'm 26 years old and I just wanted to comment in response to the mother who just talked about not wanting to get her daughter vaccinated due to the fact that she would hope her daughter would practice safe sex. And I chose to get myself vaccinated three years ago at 23 and at the time I was practicing safe sex and I still ended up getting HPV. And my discussion I had with my doctor about it is that condoms don't necessarily prevent HPV and the fact that even though I did get in, and I ended up getting a high-risk strain, the fact that I had the vaccine was actually helpful to me and to my system. So I just feel really strongly that you can practice all the safe sex you want but it's still a possibility and I just don't think many, many people are aware of the fact that even using condoms, you can still contact it.
CAVANAUGH: Thank you very much, Linda. And is that typical, if someone actually has HPV to get a vaccination? Will that help at all?
DR. LOPER: Well, absolutely because – well, the vaccine can protect against four different strains and it – you know, even if one has already been exposed and is infected with one strain, you can still protect against the other three.
CAVANAUGH: Interesting. Okay. I understand what you're saying. Let's take another call. Clayton is calling from El Cajon. Good morning, Clayton. Welcome to These Days.
CLAYTON (Caller, El Cajon): Good morning. How are you?
CAVANAUGH: Great. I'm fine.
CLAYTON: I have a question for the doctor. I've been listening to everything you guys have been saying and I have a two-year-old girl at home right now. My question is will Gardasil end up being one of those vaccinations that becomes mandatory, say like tetanus or something like that?
CAVANAUGH: That's a good point, Clayton, because now it's not, is it, Doctor?
DR. LOPER: No, it's a voluntary and optional vaccine. Yes.
CAVANAUGH: And even though when people – when your patients and their parents come in for the annual vaccinations and the annual checkup they need before they go back to school, you're going to be recommending Gardasil but it's not something they have to take in order to get back into school.
DR. LOPER: That's correct.
CAVANAUGH: And what is your feeling? Do you think it will become mandatory?
DR. LOPER: Well, I don't have a crystal ball. I'm not sure. I think because of the social implications of this particular vaccine, I don't anticipate it becoming a mandatory vaccine but it may be. There was a – The governor of Texas, actually, has a sister who had cervical cancer and I – I'm not sure if she survived or not but I do know that the governor of Texas signed an executive order a couple of years ago to make Gardasil mandatory and was met with so much – you know, the opponents were so loud that the legislature kind of cooled that – cooled that off. You know, in terms of whether it's going to be mandatory or not, really there are no vaccines that are truly mandatory because at any school you – a parent who objects to any of the vaccines can sign a religious waiver or a philosophical objection and still get their children in school, which is why we recently had an outbreak of – of, oh my gosh…
DR. LOPER: …measles, yeah, measles, measles in the Linda Vista area, if I believe – Yes.
CAVANAUGH: Right. Exactly. Now I'm going to ask you a personal question with all that you know. I don't know if you have daughters but if you have daughters or if you have nieces, would you, indeed, have them inoculated with Gardasil at this point?
DR. LOPER: I would. I have a ten-year-old niece, in fact, and I have two daughters myself who are both four. And I will vaccinate them, yes.
CAVANAUGH: So the whole idea behind this is that – is it true that most inoculations carry some small risk with them but the benefits of what they inoculate you against really outweigh those small risks?
DR. LOPER: Absolutely. I – You've summarized it beautifully right there. I think, you know, in this country we're lucky to have such good healthcare. We have vaccinations against diseases that kill children all over the world in third world nations where vaccination is not available. You know, is this particular vaccine sort of beyond, you know, what we've done up to now? It is. It is, and it's wonderful because, you know, my girls, you know, may end up getting a different pap smear schedule and not have to undergo annual pap smears. You know, vaccinated women may end up getting theirs every two to three years whereas unvaccinated may have a different schedule. We're not sure about that yet but just knowing that they're going to have a much less likelihood of a horrible disease later in life, you know, feels really good. I mean, most people that get the vaccine really just get, you know, a little bit of irritation at the site for a day and they're done. That's all.
CAVANAUGH: I want to thank you so much, Dr. Karen Loper, Associate Clinical Professor of Pediatrics and part of the Division of Adolescent Medicine at UCSD Medical Center. Dr. Loper, thank you.
DR. LOPER: Thank you for having me.
CAVANAUGH: I want to let you know that if you didn't get in and talk to us, you can post your comments online, KPBS.org/TheseDays. Stay with us. The second hour of These Days is ahead in just a moment.