HPV vaccine researcher blasts mandates, calling it public health experiment

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" Trust Us - Vioxx now Gardasil - 2 great Merck Products "

http://ahrp.blogspot.com/2007/03/hpv-vaccine-researcher-blasts-marketing.html

HPV vaccine researcher blasts mandates, calling it " public health experiment "

AHRP's stated rationale for objecting to a policy mandating Merck's HPV

vaccine in 11 year old girls [Link] 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 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 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

induced disasters.

In Texas the " Hands Off Our Kids " Coalition Wins against mandatory HPV

vaccine! Watch Fox News Channel " The Big Story " with Gibson Tonight at

5 pm EDT

[Link]

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 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 GlaxoKline, 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 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 , 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

GlaxoKline 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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Sheri Nakken, R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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