stated rationale for objecting to a policy mandating Merck's HPV vaccine
in 11 year old girls [
is validated by an internationally recognized expert in the field who
tested the vaccine in clinical trials.
Dr. Diane M. Harper, a lead researcher in the development of the human
papilloma virus vaccine, who says giving the drug to 11-year-old girls
"is a great big public health experiment."
Dr. Harper, 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, said: "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
All of her trials have been with subjects ages 15 to 25. "This vaccine
has 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."
Dr. Harper said, Merck was required to put together a database on the
efficacy in children before Gardasil was approved. 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."
She 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
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.
Dr. Harper said, she's been trying for months 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.
Something is very wrong with this commerically driven frenzied marketing
which all those who shape public policy and public opinion were caught
shilling for Merck.
Independent advocates need to take to the streets to protect our
children from irresponsible pharmaceutical companies whose financial
largesse buys public officials, government agencies that are supposed to
protect us from potentially harmful drugs and vaccines, and the
uncritical transcribers of hype in the press!
What role did the FDA play in this Gardisal promotion debacle? Today the
FDA orderd manufacturers of 13 sleeping pills to add warning labels that
sleeping do indeed cause sleep driving!! Imagine 13 different sleeping
pills and all of them put pedestrians and drivers at risk of a sleeping
driver behind the wheel!! With the current regime in command, the FDA is
lending the government seal of approval to the creation of chemically
In Texas the "Hands Off Our Kids" Coalition Wins against mandatory HPV
vaccine! Watch Fox News Channel "The Big Story" with John Gibson Tonight
at 5 pm EDT
Researcher blasts HPV marketing BY CINDY BEVINGTON
Wednesday, March 14, 2007
Diane M. Harper, a lead researcher in the development of the
humanpapilloma virus vaccine, says giving the drug to 11-year-old
girls "is a great big public health experiment." (Photo contributed)
LEBANON, N.H. - 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
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
"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
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
Glaxo has stated publicly that its vaccine, Cervarix, which protects
against the two cancer-causing strains, should be on the market by
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
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.
According to Harper, the facts about the HPV vaccine are:
. 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
. It is not 100 percent effective against all HPVs. It is 100
percent effective against two types that cause 70 percent of
. 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
. 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."
. 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."
. 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.
. 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.
. 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.
. 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
"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