FDA Approves Use of Vaccine for Cervical Cancer

JEFFREY BROWN: Cervical cancer is the second-leading cause of cancer death among women worldwide, killing more than 250,000 a year. And while widespread use of pap smears has reduced its toll in the U.S., it still causes more than 3,700 deaths a year here.

Yesterday, the Food and Drug Administration approved the first vaccine to prevent the disease. And here to tell us about it is Dr. Elizabeth Garner, a gynecological oncologist at Brigham and Women's Hospital in Boston. For the record, she has no affiliation with Merck, the company that is marketing the new vaccine, called Gardasil.

Dr. Garner, I think it would help, first, to explain to us how cervical cancer is caused so we can understand how the vaccine itself works.

DR. ELIZABETH GARNER, Gynecological Oncologist: Certainly. The vast majority of cervical cancers are caused by a virus known as human papilloma virus. This is a very common virus. By the age of 50, probably about 80 percent of women have been infected at one point in time during their lives.

Most women don't get any problems from human papilloma virus, but a minority of women, for reasons that aren't entirely clear, develop precancerous changes on the cervix, which, if left untreated, will develop ultimately or can develop ultimately into cervical cancer.

JEFFREY BROWN: So the vaccine blocks the infection that, in some cases, leads to cervical cancer?

DR. ELIZABETH GARNER: Exactly. Right. And the vaccine is made of these small particles that are called virus-like particles that, to a woman's immune system, look exactly like the virus, so as if she has been infected, but they don't actually contain any of the actual viral material.

So, when giving the virus-like particles, one can elicit an immune reaction that then can prevent the changes that develop in the cervix.

JEFFREY BROWN: And how effective is this new vaccine?

DR. ELIZABETH GARNER: This vaccine is very effective. In a recent trial, it prevented pretty much 100 percent of the infections of HPV, the human papilloma virus, and also prevented about 100 percent of the precancerous changes that can develop on the cervix.

It also is important to note that this vaccine also treats or prevents the changes caused by a couple of other types of human papilloma virus which don't cause cancer, but which can cause genital warts and other problems. And the vaccine was also very effective at preventing those.

JEFFREY BROWN: Now, the vaccine was approved for girls and women aged nine to 26, but the big question at the moment is: At what age should it be given? Explain to us the issues here.

DR. ELIZABETH GARNER: So the main issue is that the vaccine is going to be most effective if it's given to a girl or a young woman before she has become exposed to human papilloma virus.

JEFFREY BROWN: And -- excuse me -- that means before she would be sexually active in...

DR. ELIZABETH GARNER: Exactly, because this is a sexually transmitted infection. And a recent study, actually, showed that by the age of 13 about 7 percent of girls will report that they've been sexually active at some point.

So, certainly by age 13, there's a significant number of girls who are already engaging in sexual activity and who already are likely exposed to human papilloma virus, so one needs to try to target girls before they've been exposed.

JEFFREY BROWN: And this is because -- again, just to clarify -- it's not as effective once a woman has been infected?

DR. ELIZABETH GARNER: Correct.

JEFFREY BROWN: OK. Now, another big question then is whether the vaccine should be made mandatory or remain voluntary, and I guess in particular whether it should be required for schools, for children going to schools.

DR. ELIZABETH GARNER: Yes. And I think that's going to end up being a rather complicated question. Because it's a sexually transmitted infection, it's going to be a somewhat different situation than for other vaccines, such as chicken pox and so on, that can be transmitted through something as simple as a sneeze.

Human papilloma virus is not transmitted that way, and so it might be a little bit more difficult to make the argument that it needs to be mandatory for school attendance.

JEFFREY BROWN: And here, in fact, there are some social conservative groups who are raising questions about it.

DR. ELIZABETH GARNER: Well, certainly, because I think similar to, for instance, oral contraception, one could be concerned that, if one tells a young girl that she's now prevented from getting cancer, or at least cervical cancer, that she will then interpret that as meaning she can have sex at a younger age.

And so Merck is, I think, going to specifically market this vaccine as a cancer prevention vaccine and not a vaccine for sexually transmitted infection.

JEFFREY BROWN: But how will the decision be made as to whether it is mandatory? Who makes that decision?

DR. ELIZABETH GARNER: The states will decide that. There's a National Advisory Committee on Immunization Practices, which is a CDC organization, and that organization will decide what the recommendations will be, in terms of scheduling, and age, and those sorts of things.

But in terms of whether the vaccine will be mandatory for girls to attend school will be a state decision.

JEFFREY BROWN: All right. Next issue is cost. My understanding is this requires three doses over six months for a total cost of $360, relatively expensive for a vaccine.

DR. ELIZABETH GARNER: Yes, it is.

JEFFREY BROWN: So is it expected that it would be covered under most private insurance plans?

DR. ELIZABETH GARNER: Well, certainly, if it's a mandatory vaccine, I think it will be covered. You know, whether it's going to be covered if it is voluntary, I think, is definitely yet to be determined.

There certainly are a lot of arguments for making it, you know, a covered vaccine. This is something that is being given, you know, to prevent a potentially lethal problem. So I do think there are arguments towards making it something that's covered, but, you know, it's definitely yet to be seen.

JEFFREY BROWN: But that would also weigh on various state programs that would have to provide it, I guess? And, of course, also for the uninsured...

DR. ELIZABETH GARNER: Sure.

JEFFREY BROWN: ... it's a big cost.

DR. ELIZABETH GARNER: Sure. Yes.

JEFFREY BROWN: Now, cost also is a factor -- we've been talking mostly about the U.S., but, as I said, this a larger problem worldwide. In the developing world, costs would no doubt be an even bigger factor. Tell us about the situation there and what kind of programs either are planned or might be planned to help.

DR. ELIZABETH GARNER: Sure. I think that Merck has indicated that they have several ideas in place.

One is that I believe they've been in contact with the Bill and Melinda Gates Foundation, who have certainly expressed some interest in helping in vaccine distribution.

I think that also the company has indicated that they will be willing to, you know, think about and consider differential pricing and perhaps selling the vaccine at cost. And I think these are potential ways to make it more available.

JEFFREY BROWN: And I mentioned earlier that the incidence is down in the U.S. because of pap smears. Is the situation in the developing world as bad as it is because pap smears are not used as much?

DR. ELIZABETH GARNER: Yes. In fact, in this country, when the pap smear was introduced as widespread screening, we saw the incidence of cervical cancer drop about 70 percent, but those pap smear programs are not available in many parts of the developing world. And so we still see high rates of cervical cancer.

JEFFREY BROWN: And I noticed that officials are still telling women that they still should get pap smears, even with this vaccine. Why is that?

DR. ELIZABETH GARNER: Well, part of the reason is I think that it's not quite clear, in fact, how long, what the longevity is of the protective response from the vaccine.

Initial studies suggest that there certainly is protection up to about five years. But, you know, if you are giving the vaccine to girls at the age of nine or 10, that only takes them to their teenage years, so I think there's still some questions about the durability of the protective effect.

Also, the vaccine covers HPV types 16 and 18, but there are certainly other hybrid types of HPV that also are known to cause cervical cancer. Types 16 and 18 cover or protect against -- or I should say cause about 70 percent of cervical cancer. So you've still got about 30 percent of cancers that are caused by other strains of HPV.

JEFFREY BROWN: And when might this new vaccine be on the market?

DR. ELIZABETH GARNER: Well, certainly Merck has indicated that they will do everything to have it out and available within about a month of FDA approval, so I think it will be available quite soon.

JEFFREY BROWN: All right. A lot of questions, but I guess a very exciting development.

DR. ELIZABETH GARNER: Yes.

JEFFREY BROWN: So, Dr. Elizabeth Garner, thank you very much.

DR. ELIZABETH GARNER: Thank you.