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A lead researcher who spent 20 years
developing the vaccine for humanpapilloma virus says
the HPV vaccine is not for younger girls, and that it
is "silly" for states to be mandating it for
them.
Not only that, she says it's not been
tested for effectiveness in younger girls, and administering
the vaccine to girls as young as 9 may not even protect
them at all. And, in the worst-case scenario, instead
of serving to reduce the numbers of cervical cancers
within 25 years, such a vaccination crusade actually
could cause the numbers to go up.
"Giving it to 11-year-olds is a
great big public health experiment," said Diane
M. Harper, who is a scientist, physician, professor
and the director of the Gynecologic Cancer Prevention
Research Group at the Norris Cotton Cancer Center at
Dartmouth Medical School in New Hampshire.
"It is silly to mandate vaccination
of 11- to 12-year-old girls There also is not enough
evidence gathered on side effects to know that safety
is not an issue."
Internationally recognized as a pioneer
in the field, Harper has been studying HPV and a possible
vaccine for several of the more than 100 strains of
HPV for 20 years - most of her adult life.
All of her trials have been with subjects
ages 15 to 25. In her own practice, Harper believes
the ideal way of administering the new vaccine is to
offer it to women ages 18 and up. At the time of their
first inoculation, they should be tested for the presence
of HPV in their system.
If the test comes back negative, then schedule the follow-up
series of the three-part shots. But if it comes back
positive?
"Then we don't know squat, because
medically we don't know how to respond to that,"
Harper said.
Harper is an independent researcher
whose vaccine work is funded through Dartmouth in part
by both Merck & Co. and GlaxoSmithKline, which means
she is an employee of the university, not the drug companies.
Merck's vaccine, Gardasil, protects against four strains
of HPV, two of which cause genital warts, Nos. 6 and
11. The other two, HPV 16 and 18, are cancer-causing
viruses.
Merck's vaccine was approved last year
by the Food and Drug Administration, and recommended
in June for females ages 9 to 26 by the Centers for
Disease Control's Advisory Committee on Immunization
Practices (ACIP).
Glaxo has stated publicly that its vaccine,
Cervarix, which protects against the two cancer-causing
strains, should be on the market by 2008.
As the director of an international
clinical trial for these vaccines, and as author of
lead articles about the vaccines' effectiveness, Harper
has been quoted widely as saying this vaccine could
have enormous potential to eradicate the great majority
of cervical cancers.
Not tested on young girls
Picking up on this, but before the trials
were even completed, major news media and women's advocacy
groups began trumpeting the vaccine as an answer to
cancer of the cervix.
Once it was approved by the FDA and
ACIP, Women In Government (WIG), a non-profit organization
comprised of female state and federal legislators, began
championing Merck's vaccine in their home states, with
many of the ladies introducing legislation that would
mandate the vaccine for 11- and 12-year-olds.
In Indiana, Sen. Connie Lawson, R-Danville,
introduced such a bill in this year's General Assembly,
but in the face of strong opposition, it was reduced
to an education/information-only bill that requires
data collection on any Hoosier girls who do get the
vaccine. The bill is now awaiting a hearing in the Indiana
House.
So far at least 26 states are reported
to be considering some form of legislation requiring
the new vaccine for younger girls. In February, Republican
Texas Gov. Rick Perry bypassed his legislature and mandated
it for all 11- and 12-year-old girls in his state. Monday,
The Associated Press reported that New Mexico's governor,
Democratic presidential contender Bill Richardson, is
set to sign a bill requiring sixth grade girls in his
state to get the vaccine.
The idea is to inoculate them before
they become sexually active, since HPV can be spread
through sexual intercourse.
But that idea, no matter how good the
intentions behind it, is not the right thinking, Harper
said. The zealousness to inoculate all these younger
girls may very well backfire at the very time they need
protection most, she said.
"This vaccine should not be mandated
for 11-year-old girls," she reiterated. "It's
not been tested in little girls for efficacy. At 11,
these girls don't get cervical cancer - they won't know
for 25 years if they will get cervical cancer.
"Also, the public needs to know
that with vaccinated women and women who still get Pap
smears (which test for abnormal cells that can lead
to cancer), some of them will still get cervical cancer."
The reason, she said, is because the
vaccine does not protect against all HPV viruses that
cause cancer - it's only effective against two that
cause about 70 percent of cervical cancers.
For months, Harper said, she's been
trying to convince major television and print media
to listen to her and tell the facts about the usefulness
and effectiveness of this vaccine.
"But no one will print it,"
she said.
The rest of the story
According to Harper, the facts about
the HPV vaccine are:
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It is not a cancer vaccine or cure.
It is a prophylactic - preventative - vaccine for
a virus that can cause cancer. "Merck has proven
it has zero percent effectiveness for curing cancer,"
Harper said. "But it is a very, very good vaccine
that prevents types of HPV responsible for half
of the high-grade cervical lesions that cause about
70 percent of cervical cancers. For the U.S. what
that means is the vaccine will prevent about half
of high-grade precursors of cancer but half will
still occur, so hundreds of thousands of women who
are vaccinated with Gardasil and get yearly Pap
testing will still get a high-grade dysplasia (cell
abnormality)."
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It is not 100 percent effective
against all HPVs. It is 100 percent effective against
two types that cause 70 percent of cervical cancers.
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The vaccine only works if the woman/girl
does not have a current vaccine type related infection
(in other words, the vaccine only works when the
woman/girl does not have HPV 6, 11, 16 or 18 - the
viruses that Gardasil targets when she receives
her first vaccine shot).
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The vaccine doesn't care if the
girl/woman has been sexually active, Harper said.
"HPV is a skin-to-skin infection. Although
the only way to get cervical dysplasia is through
an HPV infection, and HPV is most often associated
with sexual activity, HPV is not just spread through
sex. We have multiple papers where that's documented.
We know that 3-year-olds, 5-year-olds, 10-year-olds,
and women who have never had sex have been found
to be positive for the cancer-causing HPV types."
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Therefore, for example, if a girl
is positive for HPV 16 when she is inoculated with
the vaccine at any age, she will not be protected
against it later, Harper said. "That means
it's a failure and those people are at risk for
getting the HPV 16 and 18 cancers later."
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The only way to test for the presence
of HPV is through a vaginal swab - which is inappropriate
for young girls, she said.
So what happens if the girls
are vaccinated anyway, not knowing whether they
were carrying the virus at the time of their inoculation?
"They will not be protected if they were positive
for the virus at the time they are vaccinated,"
Harper said.
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That is why it is important to
note that the vaccine has not been tested for efficacy
(effectiveness) in younger girls, she said. Instead,
the effectiveness was "bridged" from the
older girls to the younger ones - meaning that Merck
assumed that because it proved effective in the
older girls, it also would be effective in the younger
ones. The actual tests on the younger girls, ages
9 to 15, were only for safety and immune response,
Harper said, and then only as a shot by itself,
or in combination with only one other vaccine, Hepatitis
B. It has not been tested in conjunction with any
other shots a girl receives at about age 11, Harper
said.
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So far more than 40 cases of Guillian-Barre
syndrome - a dangerous immune disorder that causes
tingling, numbness and even paralysis of the muscles
have been reported in girls who have received the
HPV vaccine in combination with the meningitis vaccine.
Scientists already know that sometimes a vaccine
can trigger the syndrome in a subject. "With
the HPV vaccine, it is a small number but higher
than is expected, and we don't know if it's the
combination of the two, or the meningitis alone,"
Harper said.
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In the end, inoculating young girls
may backfire because it will give them a false sense
of protection. And, for both young girls and women,
because the vaccine's purpose has been so misinterpreted
- and mis-marketed - Harper feels that too many
girls and women who have had the vaccine will develop
a false sense of security, believing they are immune
to cancer when they are not, and failing to continue
with their annual Pap exams, are crucial to diagnosing
dysplasia before it can develop into cancer.
Keep getting pap smears
The message to consumers, Harper said,
is don't stop getting Pap smears just because you've
gotten the HPV vaccine.
"This vaccine is good, and it will
save a huge number of lives around the world,"
Harper said. "But an important point is that, if
women get the vaccine and then not get their Pap smears,
or decide to get them infrequently, what will happen
in the U.S. is that we will have an increase in cervical
cancer, because the Pap screening does a very good job.
"That's my main diatribe. We don't
need mandatory vaccinations for little girls. What we
do need to ask, though, is how long does it last, and
when do you need a booster?"
Message for governors
For the governors of the states in this
country, Harper has another message. One has to do with
the fact that vaccinating little girls now is not going
to protect them later. Since it can take a decade or
more to even manifest itself as dysplasia, the HPVs
against which this vaccine works may infect a little
girl at the age she needs the vaccine most - meaning
she will have to have a booster at the right point in
time or she will not be protected. And, remember, it
won't work at all if she was positive for the virus
when she was inoculated in the first place.
Merck knows this, Harper said. "To
mandate now is simply to Merck's benefit, and only to
Merck's benefit," she said.
Merck was required to put together a
database on the efficacy in children before Gardasil
was approved, Harper said. But instead, the company
put together four study sites that "are not necessarily
representative, and may not even have enough numbers
to determine what they need to know."
Since she doesn't personally have access
to the money Merck and GlaxoSmithKline pay for her HPV
vaccine research, Harper doesn't know exactly how much
either has paid Dartmouth for her work.
The trials are expensive, between $4,000
and $5,000 for each patient, she said. With over 100
patients in her study, some big bucks could be in the
balance, should Merck or Glaxo become upset with her
for making these comments.
Why, then, would she risk speaking out
like this - at a time when her words very well could
influence legislation across the country, and prompt
legislators to drop the mandates? Isn't she afraid of
losing her funding?
"I want to be able to sleep with
myself when I go to bed at night," Harper said.
"My concern is still, let's get women's health
better. It is still a good vaccine. But let's be honest.
Don't over-promise."
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