NVIC Vaccine E-NewsletterJuly 07, 2008

HPV Vaccine Victims Pile Up: $1.5B for Merck

by Barbara Loe Fisher

http://www.vaccineawakening.blogspot.com

http://www.NVIC.org

http://www.StandUpBeCounted.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 Perry 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


Amanda's mother describes her daughter as "a
beautiful, active girl that was brought down." Only 14
when she was vaccinated, Amanda "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.



Amanda's mother said "The doctors thought we
were
CRAZY when we mentioned that the HPV vaccine
could cause this."



"Amanda 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 Amanda 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 Amanda 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 Amanda's Mom believe Amanda 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?





__________________________________________






"Katherine 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. Katherine's
mother, Michelle 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 Perry 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." - Jessica Myers,
Dallas Morning News (June 6, 2008)
http://www.dallasnews.com/sharedcontent/dws/news/localnews/stories/DN-vaccine_06\
met.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." - Hilary Hylton-Austin, Time/CNN
(June 19, 2008)
http://www.time.com/time/health/article/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-recor\
ds-detailing-ten-new-deaths-140-serious-adverse-e



"About a month after being vaccinated
against the cervical cancer-causing HPV virus, 13-
year-old Jenny 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 Jenny carries genes that predisposed her
to problems with the Gardasil vaccine. At age 10,
Jenny 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?....Jenny
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-te\
ens-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 Jessica 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. - Susan Edelman and
Bruce Golding, New York Post (July 6, 2008)
http://www.nypost.com/seven/07062008/news/nationalnews/feds_warning_shot_118716.\
htm


* Make a difference SUPPORT NVIC

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

HPV vaccine's suspected side effects cause concern;
CDC says drug is safe

by Jessica Myers

Dallas Morning News

June 6, 2008

http://www.dallasnews.com/sharedcontent/dws/news/localnews/stories/DN-vaccine_06\
met.ART.North.Edition1.46ef875.html



~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~



Katherine 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.

Katherine 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.



Katherine's mother, Michelle 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 Katherine
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 John 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.



Jennifer Allen, 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
Katherine 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 Perry 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."



Joseph 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. Jennifer 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 Hilary Hylton/Austin

Time/CNN

June 19, 2008


http://www.time.com/time/health/article/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 Michelle Kimzey, who said that her 14-year-old
daughter Katherine, 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 Allen, while doctors, patients and
parents are encouraged to do so. The CDC regards
the VAERS as "an early warning system," Allen 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 Jessica 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
Allen 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-te\
ens-paralysis.htmlAbout a month after being vaccinated against thecervical
cancer-causing HPV virus, 13-year-old JennyTetlock missed the lowest hurdle in
gym class, thefirst hint of the degenerative muscle disease that, 15months
later, has left the previously healthy teenagernearly completely paralyzed. Did
the vaccine, Gardasil,cause her condition? Her father, Philip Tetlock,
apsychology professor at UC-Berkeley's Haas Schoolof Business, has embarked on
an odyssey to find outwhether the vaccine or random coincidence is toblame.As
father and scientist, Tetlock has contacted topmedical experts, posted pleas on
discussion boardslooking for other teens who've experiencedneurological problems
post-vaccination and has beendesperately trying to get the government to open
aninvestigation into his daughter's case. "Theweakening process is gradual so it
may take monthsfor parents to notice what is going on," he writes me inan
E-mail. He started a blog a few weeks ago thatshows photos of his sweet-faced
teen and reveals hisanger and frustration in the form of a box counting thedays
that he has yet to get a response from thegovernment's Clinical Immunization
SafetyAssessment Network. As of today, it's 28.He's not the only one to raise an
alarm. Theconservative public watchdog group Judicial Watchhas been periodically
obtaining adverse event reportson Gardasil from the Food and Drug
Administration. Ireceived the group's latest warning this week: of 10deaths
linked to Gardasil since September 2007 and140 reports so far this year of
serious effects such asmiscarriage and Guillain-Barré syndrome, a nervoussystem
disease that causes weakness and tingling inthe arms and legs. (But these
reports filed by patientsor doctors with the government's vaccine adverseevent
reporting system may or may not reflect truevaccine risks. Some problems may be
missed orunderreported, while others, including sudden deaths,may have nothing
to do with the vaccine itself.)Judicial Watch opposes efforts in many states
tomake the vaccine mandatory for all girls ages 11 and12. Those efforts have
raised concerns amongreligious groups that protecting against the
sexuallytransmitted virus will encourage promiscuity amongteen girls. The FDA
insists there's no medical reasonto be worried. "We're monitoring the safety of
the HPVvaccine very carefully, and the only adverse event thatcauses some
concern is syncope or fainting after thevaccine," says Robert Ball, director of
the FDA's officeof biostatistics and division of epidemiology at thecenter for
biologics evaluation and research. Higherrates of Guillain-Barré have been
associated with theswine flu vaccine and possibly with the meningitisvaccine
Menactra, but it is no more common in thosewho get Gardasil than in those who
don't, says Ball.The same goes for other side effects likespontaneous
miscarriage.What's more, the FDA has not documented anyother cases of
vaccine-related peripheral motorneuropathy-what Jenny has-either in the
adverseevent reports filed by doctors and patients or in themanufacturer's
clinical trial data. Merck, the vaccine'smanufacturer, has dismissed the
possibility thatJenny's condition was caused by Gardasil. "We'reaware of this
case and based on the facts that we'vereceived, the information doesn't suggest
that thisevent was causally associated with vaccination," saysMerck spokesperson
Kelley Dougherty.Tetlock, though, wonders if Jenny carries genesthat predisposed
her to problems with the Gardasilvaccine. At age 10, Jenny developed a rare
skindisease called pityriasis lichenoides that's thought tobe triggered by an
overactive immune system, and hergrandmother died of a nervous system
disease.Could it be that certain genetic tendencies makesome people more likely
to develop severe reactionsfrom vaccines? I ask Ball. "That's an
importantquestion," he responds. "We just don't know." It'scertainly going to be
a topic of future research, headds. The Centers for Disease Control
andPrevention is starting to look at whether those whodeveloped Guillain-Barré
after being vaccinated sharea common set of genes. So Tetlock could find
outsomeday if his hunches are correct.At this moment, he and his wife, Barbara
Mellers,also a professor at Berkeley, are focused on beingwith their daughter as
she struggles to breathe on herown. "Jenny endures terrible suffering each
day,"Tetlock tells me via E-mail. "She must watch hercapacity to control her own
body gradually ebb away-and each day her hopes of ever having a normalhuman life
recede ever further into memory. Thedisease is cruel beyond belief."As a parent,
I've wrestled with whether or when toget my 12-year-old daughter vaccinated
against HPV.As much as vaccines are vital in protecting against life-threatening
infectious diseases, they do, indeed, havethe potential to cause harm-however
rare that maybe. Evidence is mounting that the mercury-basedvaccine preservative
thimerosal could trigger autismin certain susceptible kids, as my
colleagueBernadine Healy previously reported. We don't knowyet whether Jenny's
illness is linked to Gardasil,though it's certainly plausible given the timing
ofsymptoms several weeks after vaccination, which iswhen vaccine-related
neurological problems typicallyoccur. I'm not sure whether Jenny's case has
changedmy opinion about the value of Gardasil. But it certainlyhas given me
pause.~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~FEDS' WARNING SHOTGARDASIL
Cancer Vaccine Probed ForLink To 18 DeathsNew York Postby Susan Edelman and
Bruce GoldingJuly 6,
2008http://www.nypost.com/seven/07062008/news/nationalnews/feds_warning_shot_118\
716.htmGARDASIL - a new cervical-cancer vaccine heavilymarketed to young girls
in ubiquitous ads on TV andin movie theaters - is under investigation for
possiblelinks to paralysis, seizures, and 18 deaths.Federal health officials
have logged8,000 "adverse events" in girls and women injectedwith the Merck &
Co. vaccine introduced two yearsago, more than 500 of them from New York.And
lawyers last month filed the first two claimson behalf of girls with ailments
blamed on Gardasilunder a federal program to compensate victims ofvaccine-caused
illness, The Post has learned.Both girls got the injections at their
middleschools.One is Jesalee Parsons, now 15, of Oklahoma,who began vomiting the
day she got a Gardasil shotand developed pancreatitis, her claim says."It makes
me mad because they're saying howgreat it is, but they never mention how many
peoplehave been hurt by it," Jesalee told The Post.Healthy all her life, her
family says, Jesalee hasbeen hospitalized on and off for more than a year.
Sherestricts her diet, takes pain pills and misses manyschool days."I'm pretty
sick all the time," she said.The other claim was filed for Jessica Vega
ofNevada, who came down with Guillain-BarréSyndrome, an immune-system disorder,
at age 14 - aweek after her second Gardasil shot.Thirty others have reported the
syndrome aftergetting the vaccine.JESSICA'S mom, Rhonda Vega, says the
girl'slower legs and arms were paralyzed, but she'slearned to walk again.
"Protecting girls againstcervical cancer is a fabulous thing, but if this is
what'sgoing to happen, they need to research it more," shesaid.In Florida, the
mother of 13-year-old BrittanyLeClaire said her daughter suffered headaches
andlethargy after a Gardasil shot last Aug. 13. On Sept. 2,Brittany's left leg
became paralyzed. After months on awalker, she limps.Her pediatrician "highly
recommended" thevaccination, mom Christina Bell said. "He told me itwas a cancer
preventative. I thought it was the rightthing to do. You see it advertised on TV
every 15minutes."Brittany's case is one of six being prepared forfiling by
Boston vaccine lawyer Kevin Conway. He saidother cases include "paralysis,
seizures and braindamage."Gardasil was licensed by the Food and
DrugAdministration in June 2006 for females ages 9 to 26.Sold worldwide, it's
been given to more than 8 millionUS girls and women, Merck says.The vaccine is
aimed at warding off strains of thehuman papillomavirus, or HPV, which can lead
tocancer. The vaccinations cost a total $360.Securities and Exchange
Commissiondocuments show Merck made $1.5 billion in Gardasilsales last year.ONE
doctor who helped conduct clinical trials onGardasil told The Post the vaccine
has beenaggressively marketed to girls too young to need it."There's a huge push
for giving this to girls 11and 12 years of age," said Dr. Diane Harper
ofDartmouth Medical School. "There's no hurry. You cangive it to someone who is
20, 25 or 30 and still havethe same level of protection."The Vaccine Adverse
Event Reporting System,run by the FDA and the Centers for Disease Controland
Prevention, has collected thousands of reports ofhealth problems after Gardasil
shots.The fatalities include:* A 17-year-old New York girl who collapsed anddied
on Feb. 22 this year, two days after the last ofthree Gardasil injections. An
autopsy could notpinpoint the cause, but doctors suspect a heart-rhythm
disorder.* An 11-year-old who suffered a heart attack inMay 2007, three days
after a Gardasil shot. The nursewho reported it said a doctor blamed it on
"ananaphylactic [severe allergic] reaction to Gardasil."The feds could not
confirm the case.* A 12-year-old girl with no prior medicalproblems who died in
her sleep on Oct. 6, 2007, threeweeks after a Gardasil shot.DR. John Iskander,
the CDC's acting director forimmunization safety, said a review of 10
confirmeddeaths found no common thread. Officials "concludedto the degree of
certainty possible" that Gardasilwasn't to blame."It's tragic that young,
apparently healthy people,do die," Iskander said.But he added that doctors hold
special meetingsweekly to review new cases, and compare them toprior
ones.Fainting is the main symptom linked to Gardasil,he said.Merck spokeswoman
Kelley Dougherty said thecompany "actively monitors" reports of side effects."An
event report does not mean that a causalrelationship between an event and
vaccination hasbeen established - just that the event occurred
aftervaccination," she said.A Post analysis of adverse- event reports
filedthrough April 30 found that about 20 percent followedinjections of
Gardasil, plus up to seven other vaccinesat the same time - including shots to
prevent flu,chicken pox, hepatitis and tetanus. Almost 6,300cases involved
Gardasil alone.Under a federal law passed in the late 1980s,victims of vaccines
may file a claim under the VaccineInjury Compensation Program, but cannot sue
thepharmaceutical.Last year, the government added HPV to a list ofvaccines,
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
$1million.susan.edelman@...~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~N\
ational Vaccine Information CenterNVIC E-News is a free service of theNational
VaccineInformation Center and is supported through donations.NVIC is funded
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