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Should the HPV Vaccine Be Required?

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Should the HPV Vaccine Be Required?

Health Care

Should the HPV Vaccine Be Required?

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NEAL CONAN, host:

This is TALK OF THE NATION. I'm Neal Conan, in Washington.

Vaccines made common childhood diseases - mumps, measles and rubella - nowhere near as common as they used to be, and today many states require proof of vaccination before they allow children into school. Now lawmakers are beginning to debate whether to add another vaccine to the must-have list of immunizations.

It's a vaccine for HPV, and it protects against certain strains of the human papillomavirus, the main cause of cervical cancer and genital warts. Unlike those other diseases, HPV is passed only through sexual contact. According to the Centers for Disease Control and Prevention, it's the most commonly sexually transmitted infection in the United States, with more than 6 million people infected every year. Twenty states are already considering whether to require girls to take the human papilloma vaccine in middle school. Texas has already done so. We'll hear about the controversy there in a few minutes.

And later in the program, the aftershocks of the Super Bowl Snickers ad. But first, HPV vaccine. What is it? How does it work? Should it be mandatory? Our number is 800-989-8255. That's 800-989-TALK. E-mail is talk@npr.org.

Robert Rose is associate professor medicine and of microbiology and immunology at the University of Rochester Medical School in New York, and he joins us today from the studios of member station WXXI in Rochester, New York. And nice to have you on the program today.

Professor ROBERT ROSE (Microbiology and Immunology, University of Rochester Medical School): Thanks, Neal. It's nice to be here.

CONAN: You were involved in the development of this vaccine. First of all, congratulations. And second of all, how does it work?

Prof. ROSE: Thank you. Well, it's a nonliving, noninfectious recombinant vaccine that stimulates a protective immune response - an antibody response that is able to neutralize the virus. So the antibodies prevent the virus from infecting.

CONAN: And it's important to note that this is not a vaccine against cancer. It's a vaccine against this HPV virus.

Prof. ROSE: That's correct. But immunization appears to quite readily prevent the precursor lesions of cervical cancer, so the expectation is that it will prevent cervical cancer.

CONAN: The expectation. You were involved in clinical trials. What were those -what were the questions that came up then, and how did the human papillomavirus do in those trials?

Prof. ROSE: Well, cervical cancer caused by human papillomavirus takes a long time to develop after infection, usually on the order of 10 to 20 years. So the development of cervical cancer per se was not a clinical endpoint in the trials. Instead, researchers looked at the incidence of the precursor lesions, which are either moderate or severe dysplasia, CIN2 or 3. And in the vaccinated group, in the Merck of a phase three study, there were no incidences of mild or moderate or severe dysplasia, and there were quite a few in the placebo group.

CONAN: Mm-hmm. Now this vaccine...

Prof. ROSE: So it worked perfectly.

CONAN: It worked perfectly. And were there any side effects?

Prof. ROSE: None other than those usually associated with injection vaccines -pain and soreness at the site that's trangent(ph), mild inflammation lasting a few days at most.

CONAN: And as I understand the - this vaccine has now been out for about a year or so, and have there been in problems with it?

Prof. ROSE: None to date, beyond the adverse effects we just discussed. It's been out - it was approved June 8th of 2006, so it's about eight months into it.

CONAN: Mm-hmm. There is, as you know - this is just for girls, correct?

Prof. ROSE: At this point, it's been approved for use in girls and women ages nine to 26. The Advisory Committee on Immunization Practices recommended universal vaccination of 11 and 12-year-old girls.

CONAN: Mm-hmm.

Prof. ROSE: There are studies ongoing to evaluate the vaccine in males to see whether or not that would have any effect on interfering with the transmission of the virus by males, and whether or not it would prevent disease in males. The Merck vaccine, in addition to the cervical cancer strains, it includes virus-like particles derived from the strains that cause benign genital warts...

CONAN: Mm-hmm.

Prof. ROSE: ...which occur with equal frequency in males and females.

CONAN: So it would have some protective effect...

Prof. ROSE: Might possibly. Those studies need to be completed.

CONAN: There is some concern about why it's necessary or important to give this vaccine to girls so young.

Prof. ROSE: Well, the thinking is that to vaccinate girls at that age would catch most girls before the onset of sexual activity. So the 11-to-12-year age range is thought to predate sexual debut, and the vaccine works best when the vaccine recipient has not been exposed to the virus yet.

CONAN: So it's really a question of whether the person getting the vaccine has been engaged in sexual activity. That makes it more effective if they haven't.

Prof. ROSE: Yes. Well, it makes it more effective if they haven't been exposed to the virus, which they could have sexual debut and not be exposed to it immediately, but it usually happens within the first one to two years after onset that they do get exposed to these ubiquitous viruses.

CONAN: Let's see if we can get some listeners into this conversation. A lot of people have questions about the human papillomavirus vaccine. If you'd like to ask questions of our guest - Robert Rose, who helped develop the vaccine - give us a call: 800-989-8255, 800-989-TALK. E-mail is talk@npr.org. And let's begin with Tina. Tina's calling us from New Jersey.

TINA (Caller): Hi, yes. My daughter, she did have the virus. And she had the laparoscopy, I think it was called, for mild dysplasia.

CONAN: Mm-hmm.

Prof. ROSE: Yes.

TINA: And my question is what - could she get the vaccine at this time because she's younger - I mean, she's 18 - and I do believe she - I mean, she is sexually active and will continue to be so. And I'm her mother. I'd like to think that she was always protected, but could she get the vaccination at this time after she's already been - had the virus?

Prof. ROSE: The answer is yes. The Merck formulation of the vaccine is what we call tetravalent. That means it addresses four strains of the virus. Two of the strains are the most prevalent cancer-causing strains, and the other two are the most prevalent strains associated with benign genital warts. If your daughter had dysplasia and was treated for that, it was probably caused by infection with one of those strains, and she could receive the vaccine and be afforded protection against the other three.

TINA: OK, great, thank you very much.

CONAN: Appreciate it, Tina.

Prof. ROSE: You're welcome.

CONAN: Good luck to your daughter as well.

TINA: Thank you.

CONAN: Our next guest joining us now is Gregory Zimet. He's a professor of pediatrics in clinical psychology with Indiana University School of Medicine. And he's been looking at how parents react to this vaccine. He joins us today from the studios of member station WFYI in Indianapolis, and nice to have you on the program today, too.

Professor GREGORY ZIMET (Indiana University School of Medicine): Thank you, Neal. It's nice to be here.

CONAN: Are parents accepting of this vaccine?

Prof. ZIMET: The research that's been done to date indicate that the large majority of parents are very interested in having their daughters vaccinated with this vaccine.

CONAN: And there are some questions, though. People have objected to the idea -this is a sexually transmitted infection. Why should girls so young have to be forced to have this vaccine?

Prof. ZIMET: Yeah, most of the objections - I'd have to say a relatively small percentage of parents that I've studied and other people have studied have objected to the vaccine on those grounds. There is some objection that has been - that, you know, that parents have stated around that issue.

CONAN: Mm-hmm.

Prof. ZIMET: You know, part of the reason - strategies that are age-based - in other words, you know, directing the vaccine in this case to 11 and 12-year-old girls - have been found to be much more effective than trying to do a risk-based strategy where we try to identify who's at risk and vaccinate them. Those strategies generally don't work very well. Partly identifying 11 and 12 year olds, as Dr. Rose was saying, is that it's not that all of these girls are going to have sex immediately, but that this will - is a way to make sure that all young women are protected from infection.

CONAN: Mm-hmm. Robert Rose, let me go back to you for a second. This is a, as I understand it, a - you need three injections, a course of three injections, and it's not cheap. It's $120 a shot.

Prof. ROSE: That's right. The early clinical trials and later trials all involved administration of the vaccine in three doses, spaced zero, one and six months, I believe, is the regimen that was used for Gardasil. And in that way, a very high level of immunity is achieved, and it's quite durable. At this point, it's been followed out at least four and a half to five years, and sufficient protection is maintained over that period.

CONAN: Let's see if we get another caller on the line. And this is Curtis, Curtis calling us from Tucson, Arizona.

CURTIS (Caller): Hi, I love your show.

CONAN: Thank you.

CURTIS: My comment is essentially that I think the biggest problem is that there's a hypocrisy going on with the concern is that, you know, these girls are maybe going to have intercourse more sooner or something of that nature because they're protected. But the issue is that if it was a vaccine that prevented breast cancer, I don't think anyone would object to it. And if there's anything we can do to protect our young women who - if they're going to have intercourse, likely aren't going to tell their parents about it and aren't going to get a Pap smear, which is the other protection for cervical cancer -we should do everything we can to protect them from getting the disease.

CONAN: Gregory Zimet?

Prof. ZIMET: I agree with Curtis completely. I think the concerns that somehow getting this vaccine is going to encourage young women to have sex earlier I think is largely unjustified. There's no way to study it at this point, but we have evidence from related kinds of issues that that's not an issue of concern, in fact.

CONAN: Robert Rose, if girls get this vaccine, can they stop having Pap smears?

Prof. ROSE: No, and it's actually very important to emphasize that point. The vaccine addresses the two most prevalent strains of cancer-causing HPV, and that accounts for about 70 percent of cases of cervical cancer, which means that there's another third of cases that are not caused by those strains. So even if they're vaccinated, it will be very important for girls and women to continue to have regular Pap exams.

CONAN: Mm-hmm. So that part is still vital. And as we continue, Gregory Zimet -we just have a few seconds before we have to go to a break - in terms of parental acceptance of this mandatory, a lot of people have problems with that.

Prof. ZIMET: Yeah, and I think that's where a lot of the controversy has been stirred up recently is around some of the legislation that's been proposed around mandatory vaccination. That's a complicated issue.

CONAN: Hmm. All right, thanks very much for the call, Curtis. We appreciate it.

CURTIS: Thank you.

CONAN: And we're going to take a short break. And when we continue, we'll have more with Robert Rose and Gregory Zimet about HPV and about the human papilloma vaccine that's being considered to be made mandatory for middle school girls in as many as 20 states. We'll also go to Texas, where it already has been made mandatory and hear from a state senator who's opposed to the idea or wants to wait, has some good questions.

I'm Neal Conan. 800-989-8255 if you'd like to join us - 800-989-TALK. E-mail us: talk@npr.org. This is the TALK OF THE NATION from NPR News.

(Soundbite of music)

CONAN: This is TALK OF THE NATION. I'm Neal Conan, in Washington.

We're talking about HPV, the human papillomavirus that can cause cervical cancer in girls and women, and the new vaccine for the virus. Our guests are Robert Rose, a professor of medicine at the University of Rochester Medical Center who helped develop the HPV vaccine, as well as Gregory Zimet - professor of the School of Medicine at the Indiana University Cancer Center. And, of course, you're welcome to join us. If you have questions about the HPV vaccine, what it is, how it works, whether it should be mandatory, give us a call: 800-989-8255 - 800-989-TALK. And e-mail is talk@npr.org.

And Robert Rose, I have to ask, the manufacturer - we've seen ads for Merck, the big pharmaceutical company, and a lot of people remember that Merck has been convicted in a couple of trials of hiding evidence about their drug Vioxx. Is there any concern that you have about the safety of this vaccine?

Prof. ROSE: Well, it's been tested in upwards of 30,000 women in the clinical trials, and it's now been rolled out and it's been given to several hundred thousand women - or girls - in the United States with no reported side effects other than the ones we mentioned earlier...

CONAN: Mm-hmm.

Prof. ROSE: ...and that was pain and inflammation at the injection site that's trangent. There've been a few reports of something called syncope - which is fainting - and that seems to be associated with fear of the injection itself rather than the vaccine. So at this point, there have been - there's been no indication of more severe adverse events. Adverse events can never been ruled out entirely, but at this point, the vaccine looks to be extremely safe and well tolerated.

CONAN: All right, and let's see if we can get another caller on the line. This is Mike. Mike's with us from St. Louis.

MIKE (Caller): Hello.

CONAN: Hi.

MIKE: I wanted to ask whether safe sex practices or condom usage can prevent HPV?

CONAN: Robert Rose?

Prof. ROSE: The indication is that condom usage doesn't interfere with transmission of the virus - at least it's certainly not foolproof or 100 percent effective.

CONAN: It's not foolproof.

Prof. ROSE: No.

CONAN: OK.

Prof. ROSE: To my knowledge.

Prof. ZIMET: Can I...

CONAN: Go ahead, Gregory Zimet.

Prof. ZIMET: I mean, there is some evidence - it's certainly not foolproof, but there is some evidence that condoms may provide some degree of protection, but certainly not even close to 100 percent. But they're not worthless with respect to prevention of HPV.

Prof. ROSE: I would agree with that, yes.

CONAN: OK. Mike, thanks very much for the call.

Texas Governor Rick Perry has issued a mandate requiring the HPV vaccine for all schoolgirls. That means when the new school year begins in the fall, it will be compulsory for girls entering the sixth grade to receive Gardasil, that's the vaccine's brand name. And to talk about this, we turn to Dawn Richardson, president of Parents Requesting Open Vaccine Education. She's with us from her office in Austin, Texas. It's nice to have you on the program today.

Ms. DAWN RICHARDSON (President, Parents Requesting Open Vaccine Education): Thank you for having me.

CONAN: Texas is a bit of an anomaly in terms of the states. It's the first time an executive order has been issued by the government, in this case Governor Perry, to vaccinate girls.

Ms. RICHARDSON: Yes, and what's really strange and has all the discussion going on in the legislature right now is why did he do it right at the beginning of the legislative session when the legislature was poised, ready, able and willing to take up this debate, bringing in people from all sides of the issue: the medical community, the families that this affects, the physicians who have to administer, store and get the vaccine - cost issues, efficacy, safety. The debate was shut down. There was no discussion. The legislature was shut out of the process.

CONAN: Mm-hmm. Well, I guess that's certainly a political issue there in Texas. But from your point of view, should the vaccine be mandatory?

Ms. RICHARDSON: I don't believe that it should be mandatory. I believe that public education should continue on the vaccine, on what's known about it and what's not known about it. It is - it has only been on the market since June of last year, and it was only tested in less - about 1,200 girls, from what I've read, under the age of 16. There can't be enough data out there to know how this is going to be tolerated long-term, or how effective it's going to be five, six, 10, 15, 20 years out.

It's - not that you can always wait that long for a drug to come out, but that's the whole point of follow-up studies and getting information out so people can make a decision. I think it's an important tool and it's wonderful that it's available, but mandating it at this point is premature and it can -there could be things that come up that we just don't know about yet.

CONAN: Mm-hmm. Robert Rose, you were involved in the clinical studies, as well as one of the people who helped develop this vaccine. How do you respond to some of those questions from Dawn Richardson?

Prof. ROSE: Well, I don't disagree with her. It's been tested in a very few younger girls at this point. As a biomedical researcher, to me, more information is better, but it has demonstrated a very good safety profile at this point. We've seen no evidence of adverse effects. So it's a point of concern for many people, and time will tell whether or not those concerns are well founded or not.

CONAN: Mm-hmm, do you, Robert Rose, believe that it should be mandatory?

Prof. ROSE: Are you asking me to make a policy decision? I will say that my - I have two daughters, and they're receiving the vaccine. To make it mandatory is seen by many to be a bit heavy-handed.

CONAN: Mm-hmm.

Prof. ROSE: My hope would be that parents would see the potential benefit for their children in getting this vaccine and embrace the vaccine. I don't really want to wade into policy waters, Neal, if you don't mind.

CONAN: OK, that's fair enough, Robert Rose. Let me turn to you, though, on policy matters, Dawn Richardson. And let me ask you: We're talking about mandatory, but as I understand it there are loopholes available. Parents can opt out if they don't want their children to have this vaccine.

Ms. RICHARDSON: There are limited opt-out provisions, and I believe that's probably where a lot of the concern is coming from. In Texas, the mandate that was issued through executive order by Governor Perry applies to all girls entering the sixth grade. But the problem is we have a problem in Texas where private schools don't fall under the purview of the legislature for these issues, and private schools are not required to take the exemption.

Additionally, we've seen examples with other vaccines that are currently mandated when a patient or a child when the parent doesn't have them inoculated, they have a safety concern or their child had a past reaction, it's been a hostile environment by the medical professionals down here where they've taken a heavy hand and thrown families out of their practices and won't treat them.

Additionally, we've seen some discrimination issues come up on healthcare coverage, and for a vaccine that - it's not an illness that it's like when you go to the grocery store and somebody sneezes on you and five days later you're sick. It's not something that's transmissible in the classroom. This is a sexually transmitted virus, and so people are really concerned that it's going to be very difficult for them, if the mandate goes into place, to be able to opt out, and they're going to be forced to take something that they're not ready to, either at this young an age or not interested at all.

CONAN: Mm-hmm. Here's an e-mail we have, this from Stacy in Charlotte, North Carolina. Teenagers already have to get the hepatitis vaccine. I don't remember an outcry over that. In my opinion, this controversy stems from our culture's continuing desire to control feminine - female sexuality. This issue is a reflection of the deep misogyny that remains in certain groups in the country, those who feel that controlling women's lives are more important for saving them.

And here's another, this from Denise in Michigan. My daughter will turn 12 next week. I'm planning to get the vaccine for her. To parents who refuse to get their daughters vaccinated because they believe it condones premarital sex, I ask, can you guarantee your daughter is not going to have sex outside of marriage?

While I don't approve of premarital sex - I've certainly done everything I can to instill that in my daughter - I still can't guarantee that she won't, and that's why I'm choosing the vaccine. Too many of my friends and colleagues have suffered through chemotherapy, and the thought of my daughter having to one day go through it herself when I could have prevented it - well, words can't describe how sick that thought makes me feel.

And as you say, Dawn Richardson, the case - any cancers that might be prevented wouldn't have happened for another 10 or 20 years, yet there's every indication that this will prevent cancers.

Ms. RICHARDSON: There is. But we also have to look at things in perspective -kind of backing up a little bit and looking at the whole picture. When you look at all the cancer deaths in the United States, cervical cancer represents .006 percent, and there are effective screenings and treatments for cervical cancer - granted, not for everyone, but we have limited healthcare dollars. As tough as this is, this is an extremely, extremely expensive vaccine. And when you make a mandate, things go into motion. Insurance companies have to cover in Texas. And we start looking at a prioritizing of healthcare dollars in this one area, and those resources are limited.

This vaccine will not help any of the women who are currently ages 13 to 50 who will come down with cervical cancer. We need resources also to go into the low socio-economic areas where people are having trouble having access to care, getting better delivery of health care so they can be screened and treated for cervical cancer, as well as all these other issues.

So with it being so expensive, there's an ethical question of, do we take all these money and put it here for this one vaccine that covers only a handful of strains when we have so much else that needs our attention and our money. So there's that balance that people have to ask, where do we want to spend our money on?

CONAN: Dawn Richardson, thanks very much for your time. We appreciate it.

Ms. RICHARDSON: Thank you so much.

CONAN: Dawn Richardson, president of Parents Requesting Open Vaccine Education. She's been with us from her office in Austin, Texas. And I just wanted to check monetarily, Robert Rose, the statistics, were those accurate?

Prof. ROSE: Yes, actually, the instance of cervical cancer in this country is quite low, but that's because we have the PAP Exam - it's a very effective screening tool. It's also costly. It costs about an estimated $6 billion a year to deliver the PAP Exam to everyone who needs it. And follow up in the event of an abnormal PAP Exam is quite costly.

To raise a point regarding her earlier comments, the cost of the vaccine probably would be I'll set at least to some extent by a reduction in the need for follow up. We - each year we have 300,000 to 500,000 cases of moderate and severe dysplasia, and presumably, the vaccine would present - prevent upwards of 70 percent of those cases and reduce the need for surgery in that many cases.

CONAN: Let's...

Prof. ZIMET: If I could...

CONAN: - go ahead, Gregory Zimet. Yes.

Prof. ZIMET: - say something additionally here, is that talking in percentages it makes it seem like cervical cancer somehow a trivial problem. And I think that's a mistake. The data that I've seen indicate that in the next year, upwards of 3,000 to 3,700 women will die cervical cancer in the United States. And you can describe that as a percentage that makes that look insignificant. But that's not an insignificant number. And the studies that have looked at the cost effectiveness of the vaccine really do suggest that this is a worthwhile vaccine, and though it is expensive that it offsets a lot of other costs both financial, and emotional, and physical.

CONAN: Gregory Zimit, professor of pediatrics and clinical psychology with Indiana University School of Medicine; also with us Robert Rose, associate professor of medicine, and of microbiology and immunology at the University of Rochester Medical Center who helped develop the HPV Vaccine.

You're listening to TALK OF THE NATION from NPR News.

And let's go to Shannon(ph). Shannon's with us from Buffalo, New York.

SHANNON (CALLER): Yes, hi. I was actually diagnosed with HPV back in 2003. And had a moderate to high level of cervical dysplasia and needed to have a LEEP procedure performed. And then, I had my PAPs after that were every three months, for a few times, then every six months. And then, I'm just now getting to the point where I can actually do PAP smears every year. But I just wanted to say that if somebody has informed me of the vaccine beforehand that could prevent HPV, I definitely would've done it in a heartbeat. I was 23 when I was diagnosed and I think my family probably would've backed it as well.

CONAN: And if you had a daughter?

SHANNON: Oh, no doubt. I would definitely have her protected with that vaccine. Even not knowing this fully if she would have side effects from the vaccine -if I knew that the side effects won't going to be severe - like you guys have mentioned, (unintelligible) she fainted. You know, honestly, would not matter to me as long as I knew she was protected from cervical cancer. Because now I'm at the point in my life what - you know, it's really something that I consider, and I'm very careful with my follow ups, and then make sure that I stay on schedule with the follow up for the PAP smears. So this scary thing can know that's a possibility now for my future and that I'm more at risk for - than other people who don't have HPV.

CONAN: Shannon, thanks very much and we wish you continued good luck with those screenings.

SHANNON: Thank you.

CONAN: I appreciate that. I wonder, Gregory Zimet, are there rumors out there about HPV vaccine?

Prof. ZIMET: What kind of rumors?

CONAN: Well, all kinds of rumors. I mean we're trying to discuss them. But as you know people have some problems, some people have that problems with vaccines period.

Prof. ZIMET: Right.

CONAN: As we said, some people have problems with this particular vaccine, either because of the manufacturer who they don't trust or nevertheless, or it's you know, the fact that is being given to girls so young.

Prof. ZIMET: Right. You know, there's clearly - again I think, you know, I do want to make it clear. I think most parents are interested in protecting their daughters against cervical cancer and are interested in this vaccine. I think parents make decisions about health care largely based on how well does the vaccine work in this case and what kind of diseases is it preventing. And that's the primary mode.

But, certainly there are concerns and, you know, we can see it in many of the media reports about that, you know, Merck is the company that gave us Vioxx and can they trusted. And, you know, so - and I think some of this seems to have been stimulated by the mandate legislation that has been introduced in a number of different states. And that seems to have generated a lot of anxiety.

CONAN: Well, a couple of - here's an e-mal question from Elizabeth. Our state's providing financial assistance to low-income women that want to get the vaccine if the state makes a vaccine mandatory with a provide financial assistance to a low-income woman. And I'm not sure, Gregory Zimet, would you be the qualified to answer that?

Prof. ZIMET: I can answer then Robert also wants to try and then that's fine. Yes. There's, I mean, there are different, I mean this is an important issue -there's a vaccine for children's program, which does provide some funding. Now that should cover this new vaccine because it has been approved by the government. But there's some issue about the amount of funds in different states may cover it to different extents. I think it's really important to the extent that a vaccine's mandated that financing is in place so that all children, in this case, all young women can get the vaccine and they're not put in, in any kind of financial difficulty. I think to have a vaccine mandate without financial coverage is irresponsible.

CONAN: Robert Rose.

Prof. ROSE: I agree with that. I think an underlying reason for pushing for a mandate is to make the vaccine more widely accessible to the girls that need it. So I do think there's a lot - been a lot of effort to identify ways of funding the vaccine. Several states are talking about proving it at no cost to eligible young girls and women. So that's the idea behind, I think, the major behind the mandate.

CONAN: Robert Rose, thanks very much for your time today. We appreciate it.

Prof. ROSE: Certainly.

CONAN: Robert Rose is associate professor of medicine at the University of Rochester Medical Center. He joined us today from WXXI, our member station in Rochester, New York. And Gregory Zimet, thank you for your time, too.

Prof. ZIMET: Thank you, Neal.

CONAN: Gregory Zimet is with Indiana University's Cancer Center. He's been with us from WFYI in Indianapolis. The Snickers ad when we come back. This is NPR News.

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