[NVIC] HPV Vaccine Victims Pile Up: $1.5B for Merck

[Guest guest]

HPV Vaccine Victims

Pile Up: $1.5B for Merck

by Barbara Loe

Fisher

w ww.vaccineawakening.blogspot.com

www.NVIC.org

www.Stand UpBeCounted.org

While Merck has pulled

in

$1.5B from sales of GARDASIL vaccine worldwide, there are continuing

reports that girls are being crippled and

dying after getting the HPV vaccine fast tracked and licensed by the

FDA in 2006. Although the roll-out of GARDASIL with an unparalleled

multi-million dollar mass media advertising blitz has created a

profitable market for the drug company that took huge losses from Vioxx

injury/death lawsuits, the persistent reports of

Guillain Barre Syndrome (GBS) paralysis, arthritis, seizures and sudden

loss of consciousness within 24 hours of vaccination continue to

haunt the marketing campaign.

Last week

Judicial Watch issued a report on more than 8,000 GARDASIL reaction

reports to the federal Vaccine Adverse Event Reporting System (VAERS)

obtained under the Freedom of Information Act (FOIA). A search of the

VAERS database , which includes reaction reports through April 30,

2008 released to the public by the FDA, reveals nearly 6,700 reports of

injury and death after GARDASIL.

Two GARDASIL vaccine injury claims recently were filed in the federal

Vaccine Injury Compensation Program under the National Childhood Vaccine

Injury Act of 1986.

Exactly two years ago, NVIC sounded

the first public warning about GARDASIL risks pointing out that Merck

had not adequately proven the vaccine was safe and effective to give to

girls under age 16. NVIC pointed out that pre- licensure trials were

flawed because they used an aluminum containing placebo that may have

masked the true reactivity of GARDASIL, which also contains 225 mcg of

aluminum. Like mercury, aluminum can cause inflammation in the body and

kill brain cells.

The fact that Merck had only studied the vaccine in fewer than 1200 girls

under age 16 and followed them up for less than two years before

licensure did not seem to bother doctors working for the CDC's Advisory

Committee on Immunization Practices (ACIP),

who saluted Merck smartly and promptly recommended that all 11 year

old girls entering sixth grade get three doses.

By the end of 2006, Merck had marshaled its well- paid lobbying forces

bolstered by a flashy television advertising campaign in an unprecedented

effort to persuade legislators in every state to turn CDC recommendations

into law and pass HPV vaccine mandates. Texas Governor Rick went so

far as to issue an

Executive Order mandating the vaccine for all sixth grade girls.

GARDASIL had only been on the market for a few months and nobody,

including Merck, knew the full range of side effects when GARDASIL was

given to millions of girls entering puberty. Nevertheless, the pressure

was on young girls, their parents and state legislators to trust blindly

that the vaccine had no real risks.

In early 2007, NVIC again warned the public that there were

significant risks associated with GARDASIL , especially when it was

combined with other vaccines. NVIC warned that there was evidence that

giving GARDASIL during active HPV infection may increase the risk for

cervical cancer while girls were not being tested for active HPV

infection before getting vaccinated. NVIC also advised that girls should

not drive home after getting the shot because of the risk for sudden loss

of consciousness after leaving the doctor's office.

In March 2007, the CDC admitted that there was no scientific evidence

that GARDASIL can be safely co- administered with other vaccines (like

TDaP, meningococcal, varicella, MMR, influenza). Even so, without a

second thought, the CDC urged doctors to assume safety and go ahead and

give GARDASIL simultaneously with other vaccines.

By end of May 2007 almost every state had rejected proposed mandates for

GARDASIL vaccine and there were more than 2,000 GARDASIL adverse events

reported to VAERS. In August 2007, NVIC released a

comprehensive analysis of GARDASIL reaction reports to VAERS and a

critique of the CDC's universal use recommendation. In

a letter, NVIC asked the CDC to warn doctors that the simultaneous

administration of Menactra with GARDASIL increases the risk for GBS and

other serious adverse event reports.

The CDC chose to blow off NVIC's report and do nothing.

Two years after licensure, it is clear that GARDASIL has plenty of risks

for young girls. Among the more than 130 GARDASIL reaction reports that

have been filed with NVIC's 26-year old

Vaccine Reaction Registry is one that was posted by a mother, who

witnessed what happened to her daughter on the

International Memorial for Vaccine Victims.

's mother describes her daughter as " a beautiful, active girl

that was brought down. " Only 14 when she was vaccinated,

" became weak, tired and sick to her stomach " but the symptoms

subsided. One week after the second HPV vaccination, her legs

" became very weak and she started losing feeling in her feet. "

She was hospitalized in the Intensive Care Unit for four days with a

diagnosis of Guillain-Barre Syndrome.

's mother said " The doctors thought we were CRAZY when we

mentioned that the HPV vaccine could cause this. "

" is constantly sick, " says her Mom. " Something has

suppressed her immune system so badly she can barely function. The

depression got really bad because she is experiencing a lot of pain in

her knees now and can't do any sports. She was once very active and right

now can barely go to school We were told me her doctors that there is

nothing more that they can do and that she could use a good

psychiatrist. "

How many more girls like and her mother have had their futures

stolen by a vaccine that is supposed to prevent a viral infection that is

cleared without any residual effects by more than 90 percent of all who

get it to prevent a cancer that causes

less than 1 percent of all new cancer cases and cancer deaths in the

U.S. every year? Did and her mother know that cervical cancer can

be prevented nearly 100 percent of the time with annual pap smears and

early intervention when pre-cancerous cervical lesions are diagnosed?

Or did 's Mom believe would be " one less " because

a pediatrician told her so?

NVIC continues to receive reports from grieving mothers and fathers who

can't find doctors to treat their once-healthy daughters who are now

chronically ill and disabled after being injected with GARDASIL. In

almost every case, the doctors are denying the vaccine had anything to do

with what happened.

The tragic denial by the medical profession of the harm vaccines can do

continues decade after decade after decade. When will doctors stop being

marketers of pharmaceutical products and implementers of government

policy and embrace the moral imperative to " first, do no harm? "

The " its all a coincidence " defense mounted by doctors when

something bad happens after vaccination is illogical, unscientific and

dangerous. When will Americans get up off their knees and stop

worshipping men and women in white coats who do not know what they are

doing?

__________________________________________

"

Kimzey started suffering debilitating headaches, fainting spells and

arthritis-like stiffness last November. Six weeks later, the 14-year-old

Dallas resident became so dizzy she could barely walk. She was

hospitalized and missed three weeks of school. Then, she had a seizure.

For weeks, she bounced back and forth between specialists and was

eventually diagnosed with epilepsy. 's mother, Kimzey,

now believes her daughter's symptoms were caused by a new vaccine that

was supposed to protect her against cervical cancer...... The HPV vaccine

has generated debate across the country and in Texas. Gov. Rick

issued an executive order in February 2007 requiring that all sixth-grade

girls get the HPV shot. But angry parents and conservative groups fought

the mandate, fearing it condoned premarital sex and took away parental

rights. The Legislature defeated the order last April. The National

Vaccine Information Center heralded the decision, saying that testing of

the vaccine was not extensive enough in girls under 12. The nonprofit

center had already started warning about the possibility of adverse

reactions such as extreme fatigue, arthritis and loss of consciousness.

Barbara Loe Fisher, co-founder and president of the center, said she's

frustrated that the CDC has " assumed safety " for Gardasil,

which has been tested only in conjunction with the vaccine for Hepatitis

B. Today, girls often receive the Gardasil shot at the same time as a

meningitis vaccine and another new booster that immunizes against

tetanus, diphtheria and pertussis. The FDA has approved all the vaccines

separately, but studies on administering them together are still ongoing.

" Not only was Gardasil put on the fast track and licensed

quickly, " said Ms. Fisher, " but to say safety is assumed and

you can give any vaccine with it is even more shocking. " -

Myers, Dallas Morning News (June 6, 2008)

http: //www.dallasnews.com/sharedcontent/dws/news/local news/stories/DN-

vaccine_06met.ART.North.Edition1.46ef875.html

" Gardasil has been a shot in the arm for pharmaceutical giant

Merck. The company had been reeling from the withdrawal of its

anti-arthritis drug Vioxx because of increased risk of heart attacks and

resulting lawsuits. Now, however, Merck's new vaccine against the human

papilloma virus (HPV) - aimed at combating cervical cancer - has been

deployed worldwide, earning an estimated $1.5 billion in sales. But the

drug is coming under increasing fire from anti-vaccine activists. Already

very vocal about childhood innoculations, now they are expressing concern

about the effects of Merck's drug on young girls, a primary focus of the

company's big ad campaign..... " This issue is not going away as more

and more vaccines are brought to the market, " Barbara Loe Fisher,

president of the National Vaccine Information Center (NVIC) who became an

activist after a serious reaction in her son to a DPT vaccine (a combined

innoculation against Diptheria, Whooping Cough - pertussis - and

Tetanus). Fisher, who has served on an Federal Drug Administration

consumer advisory committee on vaccines, takes issue with the CDC's read

of the VAERS Gardasil reports. Her organization, NVIC, has called on the

CDC and FDA to warn the public that Gardasil has been associated with at

least 15 cases of Guillain-Barre Syndrome (GBS), an autoimmune disorder;

and it says there is an increased risk for GBS when Gardasil is co-

administered with other vaccines, particularly Menactra, a meningitis

vaccine....NVIC is concerned about the growing number of vaccinations

required by schools and the push, in some public health quarters, to

mandate more vaccines. The political fight has been taken to New York and

New Jersey. New York state public health officials have endorsed state

legislation that would take the CDC's recommended vaccine list for

children and declare it to be mandatory, Fisher says, and she sees that

as a move that should alarm parents. Vaccinations should be voluntary,

Fisher says, and be made with " informed consent " by

parents. " - Hylton-Austin, Time/CNN (June 19, 2008)

http://www.time.com/time/health/artic le/0,8599,1816507,00.html

" Judicial Watch, the public interest group that investigates

and prosecutes government corruption, today released a report based on

new documents obtained from the U.S. Food and Drug Administration (FDA)

under the provisions of the Freedom of Information Act, detailing reports

of adverse reactions to the vaccination for human papillomavirus (HPV),

Gardasil. The adverse reactions include 10 deaths since September, 2007.

(The total number of death reports is at least 18 and as many as 20.) The

FDA also produced 140 " serious " reports (27 of which were

categorized as " life threatening " ), 10 spontaneous abortions

and six cases of Guillain-Barre Syndrome - all since January

2008. " - Judicial Watch (June 30, 2008)

http://www.judicialwatch.org/news/2008/jun/judicial-

watch-uncovers-new-fda-records-detailing-ten-new-

deaths-140-serious-adverse-e

" About a month after being vaccinated against the cervical

cancer-causing HPV virus, 13- year-old Tetlock missed the lowest

hurdle in gym class, the first hint of the degenerative muscle disease

that, 15 months later, has left the previously healthy teenager nearly

completely paralyzed....Her father, Philip Tetlock, a psychology

professor at UC- Berkeley's Haas School of Business, has embarked on an

odyssey to find out whether the vaccine or random coincidence is to

blame..... Tetlock, though, wonders if carries genes that

predisposed her to problems with the Gardasil vaccine. At age 10,

developed a rare skin disease called pityriasis lichenoides that's

thought to be triggered by an overactive immune system, and her

grandmother died of a nervous system disease. Could it be that certain

genetic tendencies make some people more likely to develop severe

reactions from vaccines?.... endures terrible suffering each

day. " ..... " She must watch her capacity to control her own body

gradually ebb away-and each day her hopes of ever having a normal human

life recede ever further into memory. The disease is cruel beyond

belief. " - Deborah Kotz, US News & World Report (July 2,

2008)

http://www.usnews.com/blogs/on-

women/2008/07/02/is-hpv-vaccine-to-blame-for-a- teens-paralysis.html

" Lawyers last month filed the first two claims on behalf of

girls with ailments blamed on Gardasil under a federal program to

compensate victims of vaccine-caused illness, The Post has learned. Both

girls got the injections at their middle schools. One is Jesalee Parsons,

now 15, of Oklahoma, who began vomiting the day she got a Gardasil shot

and developed pancreatitis, her claim says. " It makes me mad because

they're saying how great it is, but they never mention how many people

have been hurt by it, " Jesalee told The Post. Healthy all her life,

her family says, Jesalee has been hospitalized on and off for more than a

year. She restricts her diet, takes pain pills and misses many school

days. " I'm pretty sick all the time, " she said. The other claim

was filed for Vega of Nevada, who came down with Guillain-Barré

Syndrome, an immune-system disorder, at age 14 - a week after her second

Gardasil shot. Thirty others have reported the syndrome after getting the

vaccine. JESSICA'S mom, Rhonda Vega, says the girl's lower legs and arms

were paralyzed, but she's learned to walk again. " Protecting girls

against cervical cancer is a fabulous thing, but if this is what's going

to happen, they need to research it more, " she said......Merck

spokeswoman Kelley Dougherty said the company " actively

monitors " reports of side effects. " An event report does not

mean that a causal relationship between an event and vaccination has been

established - just that the event occurred after vaccination, " she

said. - Edelman and Bruce Golding, New York Post (July 6,

2008)

http://w ww.nypost.com/seven/07062008/news/nationalnews/f

eds_warning_shot_118716.htm

...

HPV vaccine's

suspected side effects cause concern; CDC says drug is

safe

by Myers

Dallas Morning News

June 6, 2008

http: //www.dallasnews.com/sharedcontent/dws/news/local news/stories/DN-

vaccine_06met.ART.North.Edition1.46ef875.html

Kimzey, 14, had headaches and

fainted before suffering a seizure and being diagnosed with epilepsy. She

believes her symptoms are connected to the HPV vaccine, Gardasil.

Kimzey started suffering

debilitating headaches, fainting spells and arthritis-like stiffness last

November.

Six weeks later, the 14-year-old Dallas resident became so dizzy she

could barely walk. She was hospitalized and missed three weeks of

school.

Then, she had a seizure. For weeks, she bounced back and forth between

specialists and was eventually diagnosed with epilepsy.

's mother, Kimzey, now believes her daughter's symptoms

were caused by a new vaccine that was supposed to protect her against

cervical cancer.

The symptoms started not long after had her second shot late

last year, she said. And they mirrored many of the 5,000 reports filed by

the public through a national database that monitors the safety of

vaccines after they are licensed.

" When you read everybody's stories, they're too similar not to be

related, " Mrs. Kimzey said.

But officials with the Centers for Disease Control and Prevention and

doctors nationwide said such concerns about the drug are unfounded and

most significant side effects reported are unrelated to the

vaccine.

" The safety of the vaccine is being very closely monitored, "

said Iskander, acting director for immunization safety at the CDC,

which runs the database along with the Food and Drug Administration.

Fainting, he said, has been the strongest negative response to the

vaccine.

" There certainly have been high-profile suspected side effects, some

reports of deaths, " he said, " but those have been investigated

and they don't appear to have been causally related. "

The recommendations have not changed and the vaccine will remain

available, he said.

, a spokeswoman for New Jersey- based Merck & Co.'s

vaccine division, which makes Gardasil, said Thursday that the company

conducted clinical trials for 10 years and that it remains confident in

its product.

But this hasn't assuaged Mrs. Kimzey, 41. And has refused to

get her third and final dose of the vaccine.

Gardasil was approved by the Food and Drug Administration two years ago

for girls between ages 9 and 26. It protects against sexually transmitted

diseases caused by the human papillomavirus, or HPV, responsible for 70

percent of cervical cancers and 90 percent of genital warts. Females are

encouraged to get the vaccine before they become sexually active.

Three shots are given over a six-month period. The company said 16

million doses have been administered since its approval. And it lists

nausea, vomiting and pain following the shot among the side

effects.

The HPV vaccine has generated debate across the country and in Texas.

Gov. Rick issued an executive order in February 2007 requiring that

all sixth-grade girls get the HPV shot. But angry parents and

conservative groups fought the mandate, fearing it condoned premarital

sex and took away parental rights. The Legislature defeated the order

last April.

The National Vaccine Information Center heralded the decision, saying

that testing of the vaccine was not extensive enough in girls under 12.

The nonprofit center had already started warning about the possibility of

adverse reactions such as extreme fatigue, arthritis and loss of

consciousness.

Barbara Loe Fisher, co-founder and president of the center, said she's

frustrated that the CDC has " assumed safety " for Gardasil,

which has been tested only in conjunction with the vaccine for Hepatitis

B.

Today, girls often receive the Gardasil shot at the same time as a

meningitis vaccine and another new booster that immunizes against

tetanus, diphtheria and pertussis.

The FDA has approved all the vaccines separately, but studies on

administering them together are still ongoing.

" Not only was Gardasil put on the fast track and licensed

quickly, " said Ms. Fisher, " but to say safety is assumed and

you can give any vaccine with it is even more shocking. "

ph Bocchini, chairman of the Committee on Infectious Diseases for the

American Academy of Pediatrics, says there's enough evidence to support

mixing the drugs and not enough adverse reactions to stop it.

" From the data, we already know [the vaccines] would not be expected

to interfere with each other in terms of antibody or safety, " said

Dr. Bocchini. " If we look at the number of doses given vs. the

reports, it's very clear that there are significant benefits that far

outweigh potential risks at this time. "

Dr. Bocchini cautioned that reactions that do not occur immediately, like

seizures, may actually be caused by something else. So far, he said,

there have not been enough verifiable reports of extreme side effects

through the Vaccine Adverse Event Reporting System, or VAERS, to generate

a study.

Dallas County's Health and Human Services officials said they have

received no reports of severe reactions to the vaccine.

The Texas Department of Health and Human Services said it had 210 reports

of reactions to Gardasil last year, eight of which required

hospitalization.

But officials said this is not an uncommon number for a vaccine. Dr.

Walsh said she will continue to encourage use of the vaccine

where she works, the Adolescent Medical Clinic at Children's Medical

Center Dallas.

" I'm still following the standard guidelines, " Dr. Walsh said.

" I don't have any worries at this point. "

Anti-Vaccine Activists

vs. Gardasil

by Hylton/Austin

Time/CNN

June 19, 2008

http://www.time.com/time/health/arti cle/0,8599,1816507,00.html

Gardasil has been a shot in the arm for pharmaceutical giant Merck. The

company had been reeling from the withdrawal of its anti-arthritis drug

Vioxx because of increased risk of heart attacks and resulting lawsuits.

Now, however, Merck's new vaccine against the human papilloma virus (HPV)

- aimed at combating cervical cancer - has been deployed worldwide,

earning an estimated $1.5 billion in sales. But the drug is coming under

increasing fire from anti-vaccine activists. Already very vocal about

childhood innoculations, now they are expressing concern about the

effects of Merck's drug on young girls, a primary focus of the company's

big ad campaign.

The movement's efforts and propaganda are particularly viral on the web.

One story that has been making the rounds for the past week, starting

with a report in the Dallas Morning News, concerns Dallas mother

Kimzey, who said that her 14-year-old daughter , after receiving

her second shot of the three-dose vaccine battery in November,

experienced headaches, fainting and stiff joints. A few weeks later, she

suffered a seizure and later was diagnosed with epilepsy, according to

her mother. Kimzey said that she reviewed 5,000 reports filed by the

public on a government database website that monitors vaccine safety and

became convinced that her daughter's health problems were related to the

Gardasil shot. " When you read everybody's stories, they're too

similar not to be related, " Kimzey told the News. The story has been

picked up by over a hundred mainstream media websites and by blogs and

chatrooms like vaccinationnews.com.

The government website Kimzey was referring to is VAERS - the Vaccine

Adverse Event Reporting System - a program run by the Centers for Disease

Control (CDC) and the Federal Drug Administration (FDA). Drug companies

are required to report any adverse reactions to VAERS, according to CDC

spokesman Curtis , while doctors, patients and parents are

encouraged to do so. The CDC regards the VAERS as " an early warning

system, " said, that allows them to pick up any statistical

trend that might indicate a problem. For health professionals, the VAERS

system provides some of the best data related to vaccine safety, beyond

that provided by the manufacturer, according to Kahn, M.D., a

pediatrician, HPV researcher and teacher at Cincinnati Children's

Hospital Medical Center. The danger is that such uninterpreted raw data

can also be misused. " It is very important to note, " says Dr.

Kahn, " that anyone can report a side effect to VAERS, and just

because it is reported does not mean it was caused by a

vaccine. "

For example, a study of VAERS reports of fainting among Gardasil

recipients - the medical term is syncope - published in the Journal of

the American Medical Association this month did lead to a recommendation

that patients should be kept seated or lying down for 15 minutes

following the shot. But says reports of other serious side effects,

instigated by VAERS datas, have been investigated and the CDC has not

found any causal link to Gardasil.

Nevertheless, stories like Kimzey's on Gardasil and other vaccines - many

picked up from VAERS reports - continue to fly around the web. " This

issue is not going away as more and more vaccines are brought to the

market, " Barbara Loe Fisher, president of the National Vaccine

Information Center (NVIC) who became an activist after a serious reaction

in her son to a DPT vaccine (a combined innoculation against Diptheria,

Whooping Cough - pertussis - and Tetanus). Fisher, who has served on an

Federal Drug Administration consumer advisory committee on vaccines,

takes issue with the CDC's read of the VAERS Gardasil reports. Her

organization, NVIC, has called on the CDC and FDA to warn the public that

Gardasil has been associated with at least 15 cases of Guillain-Barre

Syndrome (GBS), an autoimmune disorder; and it says there is an increased

risk for GBS when Gardasil is co-administered with other vaccines,

particularly Menactra, a meningitis vaccine.

But Dr. Kahn says there no evidence to suggests that the GBS cases

reported were caused by vaccination. " Because GBS occurs, though

rarely, in young women, it is inevitable that some cases will occur after

vaccination by chance and are not caused by vaccination, " Dr. Kahn

said. " Among 9 to 26 year- olds, the number of reports of GBS

received by VAERS are within the range that could be expected to occur by

chance alone after a vaccination. " Fisher calls that argument a

" utilitarian rationale " and said too often the numbers are

dismissed as a small sacrifice necessary for the greater good. " How

many is too many? " she asks.

NVIC is concerned about the growing number of vaccinations required by

schools and the push, in some public health quarters, to mandate more

vaccines. The political fight has been taken to New York and New Jersey.

New York state public health officials have endorsed state legislation

that would take the CDC's recommended vaccine list for children and

declare it to be mandatory, Fisher says, and she sees that as a move that

should alarm parents. Vaccinations should be voluntary, Fisher says, and

be made with " informed consent " by parents. Dr. Kuhn agrees on

that point. " Parents should ask any questions that they wish in

order to feel comfortable that they have enough information to make a

decision about vaccinating their child, " she says. " They should

bring up any concerns that they have and make sure that all of their

questions are answered before agreeing to any vaccine for their

child. "

Is HPV Vaccine to

Blame for a Teen's Paralysis?

by Deborah Kotz

U.S. News & World Report

July 2, 2008

http://www.usnews.com/blogs/on-

women/2008/07/02/is-hpv-vaccine-to-blame-for-a- teens-paralysis.html

About a month after being vaccinated against the cervical cancer-causing

HPV virus, 13-year-old Tetlock missed the lowest hurdle in gym

class, the first hint of the degenerative muscle disease that, 15 months

later, has left the previously healthy teenager nearly completely

paralyzed. Did the vaccine, Gardasil, cause her condition? Her father,

Philip Tetlock, a psychology professor at UC-Berkeley's Haas School of

Business, has embarked on an odyssey to find out whether the vaccine or

random coincidence is to blame.

As father and scientist, Tetlock has contacted top medical experts,

posted pleas on discussion boards looking for other teens who've

experienced neurological problems post-vaccination and has been

desperately trying to get the government to open an investigation into

his daughter's case. " The weakening process is gradual so it may

take months for parents to notice what is going on, " he writes me in

an E-mail. He started a blog a few weeks ago that shows photos of his

sweet-faced teen and reveals his anger and frustration in the form of a

box counting the days that he has yet to get a response from the

government's Clinical Immunization Safety Assessment Network. As of

today, it's 28.

He's not the only one to raise an alarm. The conservative public watchdog

group Judicial Watch has been periodically obtaining adverse event

reports on Gardasil from the Food and Drug Administration. I received the

group's latest warning this week: of 10 deaths linked to Gardasil since

September 2007 and 140 reports so far this year of serious effects such

as miscarriage and Guillain-Barré syndrome, a nervous system disease that

causes weakness and tingling in the arms and legs. (But these reports

filed by patients or doctors with the government's vaccine adverse event

reporting system may or may not reflect true vaccine risks. Some problems

may be missed or underreported, while others, including sudden deaths,

may have nothing to do with the vaccine itself.)

Judicial Watch opposes efforts in many states to make the vaccine

mandatory for all girls ages 11 and 12. Those efforts have raised

concerns among religious groups that protecting against the sexually

transmitted virus will encourage promiscuity among teen girls. The FDA

insists there's no medical reason to be worried. " We're monitoring

the safety of the HPV vaccine very carefully, and the only adverse event

that causes some concern is syncope or fainting after the vaccine, "

says Ball, director of the FDA's office of biostatistics and

division of epidemiology at the center for biologics evaluation and

research. Higher rates of Guillain-Barré have been associated with the

swine flu vaccine and possibly with the meningitis vaccine Menactra, but

it is no more common in those who get Gardasil than in those who don't,

says Ball. The same goes for other side effects like spontaneous

miscarriage.

What's more, the FDA has not documented any other cases of

vaccine-related peripheral motor neuropathy-what has-either in the

adverse event reports filed by doctors and patients or in the

manufacturer's clinical trial data. Merck, the vaccine's manufacturer,

has dismissed the possibility that 's condition was caused by

Gardasil. " We're aware of this case and based on the facts that

we've received, the information doesn't suggest that this event was

causally associated with vaccination, " says Merck spokesperson

Kelley Dougherty.

Tetlock, though, wonders if carries genes that predisposed her to

problems with the Gardasil vaccine. At age 10, developed a rare

skin disease called pityriasis lichenoides that's thought to be triggered

by an overactive immune system, and her grandmother died of a nervous

system disease. Could it be that certain genetic tendencies make some

people more likely to develop severe reactions from vaccines? I ask Ball.

" That's an important question, " he responds. " We just

don't know. " It's certainly going to be a topic of future research,

he adds. The Centers for Disease Control and Prevention is starting to

look at whether those who developed Guillain-Barré after being vaccinated

share a common set of genes. So Tetlock could find out someday if his

hunches are correct.

At this moment, he and his wife, Barbara Mellers, also a professor at

Berkeley, are focused on being with their daughter as she struggles to

breathe on her own. " endures terrible suffering each

day, " Tetlock tells me via E-mail. " She must watch her capacity

to control her own body gradually ebb away- and each day her hopes of

ever having a normal human life recede ever further into memory. The

disease is cruel beyond belief. "

As a parent, I've wrestled with whether or when to get my 12-year-old

daughter vaccinated against HPV. As much as vaccines are vital in

protecting against life- threatening infectious diseases, they do,

indeed, have the potential to cause harm-however rare that may be.

Evidence is mounting that the mercury-based vaccine preservative

thimerosal could trigger autism in certain susceptible kids, as my

colleague Bernadine Healy previously reported. We don't know yet whether

's illness is linked to Gardasil, though it's certainly plausible

given the timing of symptoms several weeks after vaccination, which is

when vaccine-related neurological problems typically occur. I'm not sure

whether 's case has changed my opinion about the value of Gardasil.

But it certainly has given me pause.

FEDS' WARNING

SHOT

GARDASIL Cancer Vaccine Probed For Link To 18

Deaths

New York Post

by Edelman and Bruce Golding

July 6, 2008

http://w ww.nypost.com/seven/07062008/news/nationalnews/f

eds_warning_shot_118716.htm

GARDASIL - a new cervical-cancer vaccine heavily marketed to young girls

in ubiquitous ads on TV and in movie theaters - is under investigation

for possible links to paralysis, seizures, and 18 deaths.

Federal health officials have logged 8,000 " adverse events " in

girls and women injected with the Merck & Co. vaccine introduced two

years ago, more than 500 of them from New York.

And lawyers last month filed the first two claims on behalf of girls with

ailments blamed on Gardasil under a federal program to compensate victims

of vaccine-caused illness, The Post has learned.

Both girls got the injections at their middle schools.

One is Jesalee Parsons, now 15, of Oklahoma, who began vomiting the day

she got a Gardasil shot and developed pancreatitis, her claim says.

" It makes me mad because they're saying how great it is, but they

never mention how many people have been hurt by it, " Jesalee told

The Post.

Healthy all her life, her family says, Jesalee has been hospitalized on

and off for more than a year. She restricts her diet, takes pain pills

and misses many school days.

" I'm pretty sick all the time, " she said.

The other claim was filed for Vega of Nevada, who came down with

Guillain-Barré Syndrome, an immune-system disorder, at age 14 - a week

after her second Gardasil shot.

Thirty others have reported the syndrome after getting the vaccine.

JESSICA'S mom, Rhonda Vega, says the girl's lower legs and arms were

paralyzed, but she's learned to walk again. " Protecting girls

against cervical cancer is a fabulous thing, but if this is what's going

to happen, they need to research it more, " she said.

In Florida, the mother of 13-year-old Brittany Le said her daughter

suffered headaches and lethargy after a Gardasil shot last Aug. 13. On

Sept. 2, Brittany's left leg became paralyzed. After months on a walker,

she limps.

Her pediatrician " highly recommended " the vaccination, mom

Bell said. " He told me it was a cancer preventative. I

thought it was the right thing to do. You see it advertised on TV every

15 minutes. "

Brittany's case is one of six being prepared for filing by Boston vaccine

lawyer Conway. He said other cases include " paralysis,

seizures and brain damage. "

Gardasil was licensed by the Food and Drug Administration in June 2006

for females ages 9 to 26. Sold worldwide, it's been given to more than 8

million US girls and women, Merck says.

The vaccine is aimed at warding off strains of the human papillomavirus,

or HPV, which can lead to cancer. The vaccinations cost a total $360.

Securities and Exchange Commission documents show Merck made $1.5 billion

in Gardasil sales last year.

ONE doctor who helped conduct clinical trials on Gardasil told The Post

the vaccine has been aggressively marketed to girls too young to need it.

" There's a huge push for giving this to girls 11 and 12 years of

age, " said Dr. Diane Harper of Dartmouth Medical School.

" There's no hurry. You can give it to someone who is 20, 25 or 30

and still have the same level of protection. "

The Vaccine Adverse Event Reporting System, run by the FDA and the

Centers for Disease Control and Prevention, has collected thousands of

reports of health problems after Gardasil shots.

The fatalities include:

* A 17-year-old New York girl who collapsed and died on Feb. 22 this

year, two days after the last of three Gardasil injections. An autopsy

could not pinpoint the cause, but doctors suspect a heart- rhythm

disorder.

* An 11-year-old who suffered a heart attack in May 2007, three days

after a Gardasil shot. The nurse who reported it said a doctor blamed it

on " an anaphylactic [severe allergic] reaction to Gardasil. "

The feds could not confirm the case.

* A 12-year-old girl with no prior medical problems who died in her sleep

on Oct. 6, 2007, three weeks after a Gardasil shot.

DR. Iskander, the CDC's acting director for immunization safety,

said a review of 10 confirmed deaths found no common thread. Officials

" concluded to the degree of certainty possible " that Gardasil

wasn't to blame.

" It's tragic that young, apparently healthy people, do die, "

Iskander said.

But he added that doctors hold special meetings weekly to review new

cases, and compare them to prior ones.

Fainting is the main symptom linked to Gardasil, he said.

Merck spokeswoman Kelley Dougherty said the company " actively

monitors " reports of side effects.

" An event report does not mean that a causal relationship between an

event and vaccination has been established - just that the event occurred

after vaccination, " she said.

A Post analysis of adverse- event reports filed through April 30 found

that about 20 percent followed injections of Gardasil, plus up to seven

other vaccines at the same time - including shots to prevent flu, chicken

pox, hepatitis and tetanus. Almost 6,300 cases involved Gardasil alone.

Under a federal law passed in the late 1980s, victims of vaccines may

file a claim under the Vaccine Injury Compensation Program, but cannot

sue the pharmaceutical.

Last year, the government added HPV to a list of vaccines, including

polio, hepatitis and measles, granted immunity from suit.

If victims prove a vaccine likely caused injuries, the program pays a

maximum $250,000 for death. The average payment for injury has been $1

million.

susan.edelman@...

email:

news@...

phone: 703-938-dpt3

web:

http://www.nvic.org

--------------------------------------------------------

Sheri Nakken, former R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales

UK

Vaccines -

http://www.wellwithin1.com/vaccine.htm Vaccine Dangers &

Childhood Disease & Homeopathy Email classes start again in

September