|Originally Aired: June 9, 2006
FDA Approves Use of Vaccine for Cervical Cancer
|An interview with a gynecologist looks at Gardasil, a new vaccine approved by the Food and Drug Administration for use in girls and women to prevent four strains of a virus that can cause 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
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.
When to start protection?
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
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.
Mandatory vs. morals
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
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
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.
Paying for protection
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
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
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
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
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
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
DR. ELIZABETH GARNER: Thank you.