HPV Vaccine Researcher Blasts Mandatory Marketing

HPV Vaccine Researcher Blasts Mandatory Marketing
Wednesday, 14 March 2007
Dr. Diane M. Harper, a lead researcher in the development of the
humanpapilloma virus vaccine, who says giving the drug to 11-year-old girls
"is a great big public health experiment."

AHRP's stated rationale for objecting to a policy mandating Merck's
HPV vaccine in 11 year old girls
http://ahrp.blogspot.com/2007/03/nyt-vital-discussion-clouded-mandatory.html
is validated by an internationally recognized expert in the field who tested
the vaccine in clinical trials.

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 issue."

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 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.

She said 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.

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 manufactures 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 th wheel!!
With the current regime in command, the FDA is lending the governmen
seal of approval to the creation of chemically induced disasters.

http://www.kpcnews.com/articles/2007/03/14/online_features/hpv_vaccine/hpv01.txt

Researcher blasts HPV marketing
BY CINDY BEVINGTON cindyb%40kpcnews.net">cindybkpcnews.net This email address is being
protected from spam bots, you need Javascript enabled to view it

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 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.

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 abnormality)."

. It is not 100 percent effective against all HPVs. It is 100 percent
effective against two types that cause 70 percent of cervical cancers.

. 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).

. 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 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."

For more stories on this topic, see the HPV Vaccine Series
<http://www.kpcnews.com/online_features/hpv_vaccine/>

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