----- Original Message -----
From: "NVIC" <news@...>
To: <email@...>
Sent: Wednesday, August 13, 2008 9:52 AM
Subject: NVIC] GARDASIL Vaccine: The Damage Continues


NVIC Vaccine E-NewsletterAugust 13, 2008



GARDASIL Vaccine: The Damage Continues

by Barbara Loe Fisher

w
ww.vaccineawakening.blogspot.com
(http://rs6.net/tn.jsp?e=001DXlGpOpTYUsTJ7lK0g-dUP525JGdJ467JBBzaHRYGc4gm9pPQlSV\
quQ2KaXZRJSj_i1d4SBNYayaA2Pp2ClN-6r-rQgi1wVjEm49ieqqfILfESomrI9Qy4zBFU__SZnLXaje\
d6Duhqk=)

www.NVIC.org
(http://rs6.net/tn.jsp?e=001DXlGpOpTYUujrI6D8X8xdLio67UWV9bQuOUdu6Jl4GTfHh2RQH9t\
xoXz-pFiaAMUosSMWuZplR0kujuDC7ZPEzlhvfJrpu08aBXl0xackmU=)

www.Stand
UpBeCounted.org
(http://rs6.net/tn.jsp?e=001DXlGpOpTYUtFNO3TgoekAVsqUnUjzsQwcqIvAZ0aUUmr-8A7qJXI\
xuLxhN7ugI1D0zowi1lEqYahlJ8YVBKDt0gxt6baxiLQFnvNXrXaB3g6mCbOgnAPLw==)

The vaccine reaction reports keep coming into the
National Vaccine Information Center (NVIC)
(http://rs6.net/tn.jsp?e=001DXlGpOpTYUsDk56mFRmg365arvrbFkzISR1VTRC4soUJpW7RJklx\
rNmcBHw6nYG2UvoO7s1suZbiZQjEdU_pY9wcFkINxAPRXGfL8QLQkYKTWj_socVEzdt3ZDgO07VzLRY1\
2fklLQs=)
from mothers describing how they took their healthy
teenage girls into a pediatrician or gynecologist's
office where they were given a GARDASIL shot and,
then, nothing was ever the same again. The reports
of HPV vaccine reactions, injuries and deaths
continue to roll in, not only to NVIC but also to the
federal
Vaccine Adverse Events Reporting System
(http://rs6.net/tn.jsp?e=001DXlGpOpTYUuNgF0Jp60BRQs9QwyMeUT9Iz7AxtFGx6ozJnIqS3yf\
-kBcozRzN8OkiLuf6EdKYxTS4xDWqpvK-yMlQ_IS9vtf-b3eNWJSSTXoic30UpeXM6n8ZKcQEmfThMtY\
ghl7eso=)
(Search
HPV4 at
http://www.medalerts.org/vaersdb/index.html
(http://rs6.net/tn.jsp?e=001DXlGpOpTYUuNgF0Jp60BRQs9QwyMeUT9Iz7AxtFGx6ozJnIqS3yf\
-kBcozRzN8OkiLuf6EdKYxTS4xDWqpvK-yMlQ_IS9vtf-b3eNWJSSTXoic30UpeXM6n8ZKcQEmfThMtY\
ghl7eso=))
newspapers, and television stations. And the only
response that comes from officials at the CDC, FDA
and drug companies when perfectly healthy teenage
girls collapse into unconsciousness, suffer a massive
seizure, get paralyzed or die suddenly after being
injected with GARDASIL is the zombie mantra: "It is a
coincidence."



Last week a nurse who is an administrator in the
outpatient department for a group of hospitals in
California called and asked if NVIC had been getting
reports of unusual collapse
(http://rs6.net/tn.jsp?e=001DXlGpOpTYUuaT8Z2Ujv88FiIG97wiuVOligKdZ0QLv5mS--DOJ4s\
ijOP6YpUP3vgS4eS5lRDRD5r2WX5bAtj4CvHJYUFTPHbbJ-70HHch2X4XQx928hO7tRFkxOQsHqoWYUr\
lXxW2Qb-6GJojuq_JEzbqSfEiC6dCWUv1EPAbbvuGCHweHVZlNcCfj-luPt6oatwLIQ4ibfshQyNxcSb\
VP7N8XOkpQhmRmXLjRDJZcC5zzgiRfzMO_1b7ck9zIZlv6qCK7MksSMPsucJwM_u4yBuYA69Nur96mfE\
2cTZ-PHJbETv_A3Tfw==)
after GARDASIL
vaccination. I said, yes, we are getting those reports
and she said "A lot of our patients are collapsing after
the shot is given. It happens with GARDASIL more
frequently than with any other vaccine we give." That
same week, NVIC received a report from the mother of
a 15 year old daughter who got her first GARDASIIL
shot last month. Within 10 minutes of being injected,
she collapsed and had her first grand mal seizure,
became incontinent, temporarily lost vision in her right
eye, suffered uncontrolled vomiting and had to be
taken by ambulance to the hospital. Another report to
NVIC that week also involved first-time seizures in a
15 year old girl after she got a GARDASIL shot.



Through June 30, 2008, there have been reports
that at least 17 to 20 deaths have occurred following
GARDASIL and were filed with the federal Vaccine
Adverse Events Reporting System (VAERS), although
the FDA has yet to admit even one death is causally
related to the vaccine, suggesting that the girls would
have died that day even if no vaccine had been given.
Many of the teenage girls ,who die suddenly after
vaccination without explanation, were among the
brightest and the best and in top physician condition.
This was true for 17 year old Jessica Ericzon, a New
York softball player, snowboarder and honor roll
student who dropped dead within 48 hours
(http://rs6.net/tn.jsp?e=001DXlGpOpTYUsw8qhSfoD-o87vr07KOkS8Q21PaJ-XEKo5a1o9HsUA\
A6z9iK7gsmyrHYFypBDPsT4vUejq7igOzRZnqzKxKYU7e8G9WoVWlBmd8ztb37tCPvhIYO1fibjgfM40\
Qu7efaxI93EJLvNWzQfe-ONJ5ihepZero9gmEVcRSQ_Z8KpWN_Q5XSSDYkU6COss3WXOOfBt_U-CuJsD\
QmJlNkzRhplM0PgN7gXEtqI=)
of getting a GARDASIL shot. A coroner could find no
cause for her death after an autopsy.



There have been so many reports of reactions
(http://rs6.net/tn.jsp?e=001DXlGpOpTYUvw4cbF35rYtdpaaCBuGmnuKWlLUvd6bw_2__rtUIN5\
HjDBRhBi3C3wDqxa4PC3r9Cr_wbWHla-XiFZbMWUmQ1fHyCTsJVRoyI3TSl4Br9u7UNwS3mWrRZ9ysCE\
HArZSOR2zbGIPJdoT0pla2Nas6Bj9KLQAAJ8iAo=),
injuries and deaths following GARDASIL vaccination
(20-25 percent of all vaccine adverse event reports
being filed with VAERS are for GARDASIL vaccine
reactions) that the FDA and CDC issued a
statement
(http://rs6.net/tn.jsp?e=001DXlGpOpTYUt0EKjpJgesG_I0HcYqJgQZi0Zw6P_eUAoH4_c7sMiw\
c1Cp9T0sJz191CV2NX0cyK7TjcKxuqDXVXP8BDg2-BGYKkD1WwITvQlceHl9yqrvgyluBpCr0wQfZQbo\
Z15PEgHxGT7MN9NsR1eMq6goy5ViWZALqsL-3pk=)defending
the vaccine's safety
on July 22.



But one of the vaccine's developers has urged
caution and offers practical advice about the need for
continued use of Pap screening to prevent cervical
cancer rather than relying on the vaccine to do the
job. " If you are at all concerned, then don't have the
vaccine - have regular Pap smears and you will be
equally protected from cervical cancer....Pap
screening is still the only proven method we have for
cervical cancer prevention," said Professor
Diane Harper, Ph.D.
(http://rs6.net/tn.jsp?e=001DXlGpOpTYUt0KsLcb6X6vFaDlj_tYkgflf8Q007eUbHXJqzpe0Bf\
tz2sWLX2DhAgakxvI7DsOIN2_sdQwnOK6HKaZtCgD3NxYbLdNytz1IzOz5SQopf461W6hSg1syxTW-Bv\
6N2t4dM=)
"We don't know how long
the vaccine will protect a woman from HPV infection,
and the vaccine does not protect against all types of
HPV infection that cause cervical cancer."



The "coincidence" defense mounted by doctors
and drug company officials every time a vaccination is
followed by injury and death is as old as it is
unscientific. It is amazing that they have been able to
get away with it for so long. Babies can't talk and
babies can't walk so who they will become is still a
dream. But young girls and women have already
become much of who they will be and, on the cusp of
fulfilling the dream, their vaccine deaths and injuries
are much more difficult to sweep under the carpet.




It is immoral for doctors in government and
industry to continue to look away from the damage
done when vaccines cut down the brightest and most
physically fit among us. The suggestion that these
healthy, high functioning girls were biologically
compromised and would have died or been injured
that day even if no vaccine had been given is
ludicrous. If those in government responsible for
protecting the public health and safety look the other
way when healthy individuals die and are injured by
pharmaceutical products pronounced by government
as "safe" for public use, then we cannot be assured
that any licensed drug or vaccine is safe.



Last year, the head of the FDA in China was
executed for allowing toxic pharmaceutical products to
be licensed and released for public use that ended up
killing and crippling people.







__________________________________________





"I just kept thinking about the good outcomes
rather than what could actually happen." What
happened to Crystal Olivera was arm pain so severe
that it left her unconscious immediately after a
Gardasil shot, something she had never experienced
with her hepatitis and meningitis vaccines. "The next
thing I know I am on the floor in the fetal position." Had
she known more about Gardasil - "I wish I'd waited a
little until it was out in the public more and also that
they did more research about the negative side
effects." - Jamie Colby, Fox News (July 11,
2008) SEE VIDEO at http://www.foxnews.com/video2/video08.html?
maven_referralObject=2233990&maven_referralPlayli
stId=&sRevUrl=http://www.foxnews.com/health/index.ht
ml
(http://rs6.net/tn.jsp?e=001DXlGpOpTYUuaT8Z2Ujv88FiIG97wiuVOligKdZ0QLv5mS--DOJ4s\
ijOP6YpUP3vgS4eS5lRDRD5r2WX5bAtj4CvHJYUFTPHbbJ-70HHch2X4XQx928hO7tRFkxOQsHqoWYUr\
lXxW2Qb-6GJojuq_JEzbqSfEiC6dCWUv1EPAbbvuGCHweHVZlNcCfj-luPt6oatwLIQ4ibfshQyNxcSb\
VP7N8XOkpQhmRmXLjRDJZcC5zzgiRfzMO_1b7ck9zIZlv6qCK7MksSMPsucJwM_u4yBuYA69Nur96mfE\
2cTZ-PHJbETv_A3Tfw==)



"Jessica Ericzon, 17, was "an all-
American teenager," as described by one of her
upstate LaFargeville teachers. Last February, she was
working on her softball pitches, getting ready for a
class trip to Universal Studios in Florida and hitting
the slopes to snowboard with her older brother. Then
one day, the blond, blue-eyed honors student
collapsed dead in her bathroom. It started with a pain
in the back of her head. On the advice of her family
doctor, Jessie had taken a series of three Gardasil
shots. The vaccine, marketed for females ages 9 to
26, is the first found to ward off strains of the sexually
transmitted human papillomavirus, or HPV, which can
cause cervical cancer. Jessie got the first injection in
July 2007. After her second shot in September, she
complained of a pain in the back of her head, fatigue
and soreness in some joints, said her mom, Lisa. On
Feb. 20, while on winter break from school, she got
her third and final dose of the vaccine. The next
night, "she told me the spot on the back of her head
was bothering her again," her mom said. The next
morning, Feb. 22, Lisa, a hospital technician, left for
work just after 5 a.m., leaving Jessie asleep. Jessie
never showed up for the class she was taking at
Jefferson Community College. When her mom got
home at 3:20 p.m., she found Jessie sprawled on her
back on the bathroom floor, with blood spots on her
head where it had hit a flowerpot. Jefferson County
Medical Examiner Samuel Livingstone is
stumped. "She was essentially dead by the time she
hit the floor. Whatever it was, it was instantaneous,"
Livingstone said. His autopsy found no cause."
- Susan Edelman, New York Post (July 20,
2008)
http://www.nypost.com/seven/0720200
8/news/regionalnews/my_girl_died_as_guinea_pig_fo
r_gardasil_120737.htm
(http://rs6.net/tn.jsp?e=001DXlGpOpTYUsw8qhSfoD-o87vr07KOkS8Q21PaJ-XEKo5a1o9HsUA\
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QmJlNkzRhplM0PgN7gXEtqI=)



" Katherine Kimzey got her first injection of
Gardasil along with a Hepatitis-A vaccine and a
chicken pox booster. She got the second injection two
months later, along with the D-TaP vaccination. Six
weeks after the second injection of Gardasil,
Katherine passed out. "I tried to get up and my neck
was stiff, and I couldn't move it," the teenager
explained. "I couldn't move at all." Katherine spent five
days in the hospital......Shannon Nelson, 18, from the
Chicago area, got the Gardasil shot and two other
vaccines-- at the same time. Within a week the soccer
star could barely move. "When I went into the hospital I
couldn't walk at all. I had to have a wheelchair. It just
got worse each day," she explained. Nelson spent 23
days in the hospital and while she's better now the
teenager believes one of the vaccines she received is
responsible for her illness and her neurologist says
it's certainly possible. Katherine Kimzey is back on the
soccer field in North Texas. But she still has
occasional pain and doesn't know what the future will
hold. Thinking about her past experience she says
she still worries and so does her mom. Michelle
Kimzey says next time; she won't be so quick to jump
on the new vaccine bandwagon. "I think the
connection is huge," she said.....In a statement to CBS
11 News, Merck -- the maker of Gardasil -- said it has
analyzed the reports of paralysis and death, and
believes: no safety issue related to the vaccine has
been identified." - Ginger Allen, CBS News 11 -
Dallas (July 21, 2008) http://cbs11tv.com/health/Gardasil.ce
rvical.cancer.2.776277.html
(http://rs6.net/tn.jsp?e=001DXlGpOpTYUvw4cbF35rYtdpaaCBuGmnuKWlLUvd6bw_2__rtUIN5\
HjDBRhBi3C3wDqxa4PC3r9Cr_wbWHla-XiFZbMWUmQ1fHyCTsJVRoyI3TSl4Br9u7UNwS3mWrRZ9ysCE\
HArZSOR2zbGIPJdoT0pla2Nas6Bj9KLQAAJ8iAo=)



"Consumer concerns over safety have
not been assuaged by "reassurances from the
government," said Barbara Loe Fisher, cofounder of
the National Vaccine Information Center (NVIC). "We
have heard reassurances about safety before - for
example, with the whole-cell pertussis (diphtheria-
pertussis-tetanus [DPT]) vaccine in the 1980s," she
said, noting that this was subsequently withdrawn and
replaced by an acellular version in the United States in
the 1990s. Ms. Fisher has a son whom she believes
was damaged by the DPT vaccine 28 years ago, and
she has worked ever since as an activist in the
vaccine safety field in various capacities, including a 4-
year stint as a consumer member of the FDA
Vaccines and Related Biological Products Advisory
Committee.....In addition, the NVIC has been running
its own private vaccine reaction registry for the past 26
years, and it currently has about 140 reports on
Gardasil, Ms. Fisher said. "These include reports of
injury and death, and we are seeing a pattern of what
we have termed 'atypical collapse,' " she
commented. "These include cases where a girl
suddenly passes into unconsciousness either
immediately or within 24 hours of vaccination and then
revives feeling weak and unable to speak properly or
exhibiting other neurological signs. What we are
concerned about is that girls are not aware of this
possibility and could be crossing the road or driving a
car and suddenly pass out." Ms. Fisher also outlined
concerns about how Gardasil has been studied. She
pointed out that very few of the participants in the
clinical trials were aged 11 to 12 years, which is the
recommended target age for the vaccine. The New
York Times reported in 2006 that of the 20,000 trial
participants, 1200 were younger than 16 years."
- Zosia Chustecka, Medscape Medical News
(August 8, 2008)
http://www.medscape.com/viewarticle/578110
(http://rs6.net/tn.jsp?e=001DXlGpOpTYUt0KsLcb6X6vFaDlj_tYkgflf8Q007eUbHXJqzpe0Bf\
tz2sWLX2DhAgakxvI7DsOIN2_sdQwnOK6HKaZtCgD3NxYbLdNytz1IzOz5SQopf461W6hSg1syxTW-Bv\
6N2t4dM=)








MY GIRL DIED AS 'GUINEA PIG' FOR GARDASIL

http://www.nypost.com/seven/0720200
8/news/regionalnews/my_girl_died_as_guinea_pig_fo
r_gardasil_120737.htm
(http://rs6.net/tn.jsp?e=001DXlGpOpTYUsw8qhSfoD-o87vr07KOkS8Q21PaJ-XEKo5a1o9HsUA\
A6z9iK7gsmyrHYFypBDPsT4vUejq7igOzRZnqzKxKYU7e8G9WoVWlBmd8ztb37tCPvhIYO1fibjgfM40\
Qu7efaxI93EJLvNWzQfe-ONJ5ihepZero9gmEVcRSQ_Z8KpWN_Q5XSSDYkU6COss3WXOOfBt_U-CuJsD\
QmJlNkzRhplM0PgN7gXEtqI=)
* Make a difference SUPPORT NVIC

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


...

TRAGIC: Jessica Ericzon collapsed dead days after
receiving a shot of the cervical-cancer vaccine
Gardasil.

New York Post

July 20, 2008


By SUSAN EDELMAN






She loved SpaghettiO's, pepperoni, lilies,
listening to
her iPod and making her pals laugh.



In her senior yearbook, she wrote, "The best
things in life aren't things, they're friends."



Now that's the quote chiseled into her
gravestone.



Jessica Ericzon, 17, was "an all-American
teenager," as described by one of her upstate
LaFargeville teachers.



Last February, she was working on her softball
pitches, getting ready for a class trip to Universal
Studios in Florida and hitting the slopes to snowboard
with her older brother.



Then one day, the blond, blue-eyed honors
student collapsed dead in her bathroom.



It started with a pain in the back of her head.



On the advice of her family doctor, Jessie had
taken a series of three Gardasil shots.



The vaccine, marketed for females ages 9 to 26,
is the first found to ward off strains of the sexually
transmitted human papillomavirus, or HPV, which can
cause cervical cancer.



Jessie got the first injection in July 2007.



After her second shot in September, she
complained of a pain in the back of her head, fatigue
and soreness in some joints, said her mom, Lisa.




On Feb. 20, while on winter break from school,
she got her third and final dose of the vaccine.



The next night, "she told me the spot on the back
of her head was bothering her again," her mom
said.



The next morning, Feb. 22, Lisa, a hospital
technician, left for work just after 5 a.m., leaving Jessie
asleep.



Jessie never showed up for the class she was
taking at Jefferson Community College.



When her mom got home at 3:20 p.m., she found
Jessie sprawled on her back on the bathroom floor,
with blood spots on her head where it had hit a
flowerpot.



Jefferson County Medical Examiner Samuel
Livingstone is stumped.



"She was essentially dead by the time she hit the
floor. Whatever it was, it was instantaneous,"
Livingstone said. His autopsy found no cause.



He speculates she suffered a cardiac arrhythmia,
or irregular heartbeat, extremely rare in young
people.



Jessie had been on birth-control pills for a year to
treat acne, records show.



Livingstone reported Jessie's death to the federal
Vaccine Adverse Events Reporting System.



Run by the FDA and the Centers for Disease
Control and Prevention, it has collected 8,000 reports
of problems after Gardasil shots, including paralysis,
seizures and miscarriages.



Seventeen other deaths following the vaccine
have been reported since Merck & Co. introduced it in
2006.



Officials have confirmed 11 of the reported deaths
so far, said CDC spokesman Curtis Allen.



They have found "no pattern or connection" to
Gardasil in eight deaths and are still reviewing three,
he said.



Lisa Ericzon now feels her daughter was "a
guinea pig" for Gardasil, and is urging parents to
research the vaccine before letting their daughters get
it.



"I want other mothers to know," said Lisa, the first
parent of a girl who died after Gardasil to speak
publicly.



"I don't want them to go through what I went
through."



Jessie planned to major in psychology at SUNY
Plattsburgh and pursue her greatest ambition - to
become a New York state trooper.



Just six days before she died, she got to ride
along with a trooper canine unit. She was
ecstatic
.


Her family started the Jessica Ericzon Memorial
Fund to award scholarships to her classmates.




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


Adverse Reactions Reported After Gardasil Shots

CBS 11 News (Dallas)

Ginger Allen, Reporting


July 21, 2008

http://cbs11tv.com/health/Gardasil.ce
rvical.cancer.2.776277.html
(http://rs6.net/tn.jsp?e=001DXlGpOpTYUvw4cbF35rYtdpaaCBuGmnuKWlLUvd6bw_2__rtUIN5\
HjDBRhBi3C3wDqxa4PC3r9Cr_wbWHla-XiFZbMWUmQ1fHyCTsJVRoyI3TSl4Br9u7UNwS3mWrRZ9ysCE\
HArZSOR2zbGIPJdoT0pla2Nas6Bj9KLQAAJ8iAo=)

DALLAS (CBS 11 News) ¯
The cervical cancer vaccine called Gardasil has been
on the market for about two years. Thousands of girls
and women across the country, who've received the
series of shots, have reported painful and scary side
effects and one Dallas family is going through a
similar ordeal.




Seizures, temporary paralysis and excruciating
pain - those are a few of the symptoms some have
reported after taking Gardasil. It took months for a
North Texas teen to recover and her family says the
Gardasil shots are the only explanation that makes
sense.




Dallas mother Michelle Kimzey saw the ads and
heard all of the positive news about Gardasil and how
it could help prevent cervical cancer. So when she
took her 13-year-old daughter, Katherine, to the doctor,
getting the vaccine was a 'no-brainer'.




"I thought, wow! When we left the office, I said, I
just protected her from one more disease!"




Katherine got her first injection of Gardasil along
with a Hepatitis-A vaccine and a chicken pox booster.
She got the second injection two months later, along
with the D-TaP vaccination.




Six weeks after the second injection of Gardasil,
Katherine passed out. "I tried to get up and my neck
was stiff, and I couldn't move it," the teenager
explained. "I couldn't move at all."




Katherine spent five days in the hospital.




Before the Gardasil vaccine, Katherine was a
healthy teen. Her mother suspected Gardasil had
something to do with the sudden illness, but doctors
ran every test they could think of and couldn't make the
connection.




"The most definitive answer was, that's not it,"
Michelle Kimzey said. "We can't tell you what's wrong,
but that's not it."




Barbara Loe Fisher is president of the National
Vaccine Information Center, an independent, non-
profit clearinghouse for information on vaccines and
disease. She says nearly 100 parents, including
Katherine's, have contacted the organization believing
their daughters have suffered an adverse reaction
following a Gardasil shot - at times- given in
combination with other vaccines.




Fisher says the reports of complication have
caused a real 'crisis of trust' in the hearts and minds
of parents.




Since Gardasil won FDA approval, eight million
shots have been given. Officials with the Centers for
Disease Control say more than 9,000 adverse
reactions have been reported. But only six-percent of
those are considered serious and that's less than half
of what is reported for most vaccines.




Dallas OBGYN Dr. Sheila Chhutani says half of
all women will be infected with HPV at some point
during their lives. She believes the small number of
adverse reactions is far outweighed by the vaccine's
benefits.




"So when you look at those numbers and
compare them to the numbers of adverse affects with
the Gardasil....to me, right now, there is still no
comparison."




Dr. Chhutani offers Gardasil to patients between
the ages of nine and 26. She will not however give the
injection at the same time as other vaccines. Dr.
Chhutani says there should be more investigation into
whether Gardasil -- given in combination with other
vaccines -- could cause an adverse reaction.




Shannon Nelson, 18, from the Chicago area, got
the Gardasil shot and two other vaccines-- at the
same time. Within a week the soccer star could barely
move.




"When I went into the hospital I couldn't walk at
all. I had to have a wheelchair. It just got worse each
day," she explained.




Nelson spent 23 days in the hospital and while
she's better now the teenager believes one of the
vaccines she received is responsible for her illness
and her neurologist says it's certainly possible.




Katherine Kimzey is back on the soccer field in
North Texas. But she still has occasional pain and
doesn't know what the future will hold. Thinking about
her past experience she says she still worries and so
does her mom.




Michelle Kimzey says next time; she won't be so
quick to jump on the new vaccine bandwagon. "I think
the connection is huge," she said.




The CDC is also looking into 17 reported deaths
but doesn't believe Gardasil is to blame.




In a statement to CBS 11 News, Merck -- the
maker of Gardasil -- said it has analyzed the reports of
paralysis and death, and believes: no safety issue
related to the vaccine has been identified.




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


HPV Vaccine Deemed Safe and Effective, Despite
Reports of Adverse Events

by Zosia Chustecka

Medscape Medical News

August 8, 2008




http://www.medscape.com/viewarticle/578110
(http://rs6.net/tn.jsp?e=001DXlGpOpTYUt0KsLcb6X6vFaDlj_tYkgflf8Q007eUbHXJqzpe0Bf\
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Editor's note: This article replaces "HPV Vaccine
Adverse Events Worrisome Says Key Investigator,"
which was posted on July 26, 2008, and was removed
after editorial review.

Reports of adverse events after administration of the
human papillomavirus (HPV) vaccine (Gardasil,
Merck) have been making headlines, and questions
over the safety of the vaccine have been raised by
consumers, parents, healthcare professionals, and
others, notes a recent joint statement from the US
Centers for Disease Control and Prevention (CDC)
and the Food and Drug Administration (FDA). But
having analyzed the available data, the agencies offer
reassurance.


"Based on ongoing assessments of vaccine
safety information, the FDA and CDC continue to find
that Gardasil is a safe and effective vaccine," the
agencies said in a statement released on July 22,
2008. "The benefits continue to outweigh the risks,"
they said. "This vaccine is an important cervical cancer
prevention tool," they added.


The manufacturer also issued a statement, dated
July 10, 2008, saying it too had analyzed available
data and it "believes that no safety issue related to the
vaccine has been identified. These types of events are
events that could also be seen in the general
population, even in the absence of vaccination."


Both statements were issued after several cases
of damage allegedly caused by the vaccine were
highly publicized in the lay media in the United States.
One example is the case of a 13-year-old now almost
completely paralyzed, as reported on CBS News.
Another report described a 19-year-old who collapsed
and died 2 weeks after receiving the first dose of
Gardasil. This report first appeared in East Bay
Express News (California) and was recycled on
NaturalNews.com with the headline "Girl Dies after
HPV Jab," although the report contained additional
information that the woman had been taking an oral
contraceptive, which the CDC thought contributed to
her death.


Merck spokesperson Tracy Ogden told Medscape
Oncology that the company has received many
comments from physicians and from groups
representing patients who are concerned about recent
media reports about Gardasil and the detrimental
effect they may have on vaccine uptake and protection
against cervical cancer.


"There is a great deal of hype, lack of
understanding, fear-mongering, and totally unrelated
agendas surrounding this issue. It is distressing that
these reports have absolutely nothing to do with
objective science, and objective science is the
process through which we should and must make our
decisions related to the public welfare," said Maurie
Markman, MD, professor of gynecologic medical
oncology at the University of Texas MD Anderson
Cancer Center, in Houston, who acts as an advisor to
Medscape Oncology.


"In any large population, there are going to be
events such as death and paralysis, and it is
understandable from human point of view that when
tragedy strikes, people will look around for an
explanation as to why it may have happened. But the
fact that an event happened after vaccination does not
mean that it happened because of the vaccination,"
Dr. Markman emphasized.



Data Are "Overwhelmingly Positive"



"That is why we do randomized clinical trials," he
continued, "and it is very important that 2 separate
large clinical-trial programs with 2 different products
have come to very similar conclusions." (The other
HPV vaccine, Cervarix [GlaxoSmithKline], is not
available in the United States but is marketed
elsewhere in the world). Dr. Markman pointed out that
he has no links with either manufacturer.


"The data are overwhelmingly positive that this is
an extremely safe and extremely effective vaccine," he
said.


However, Diane Harper, MD, professor of
community and family medicine/obstetrics and
gynecology at Dartmouth Medical School, in Hanover,
New Hampshire, and director of the Gynecologic
Cancer Prevention Research Group at the Norris
Cotton Cancer Center, is more circumspect. Dr.
Harper, who was involved in clinical trials with both
HPV vaccines, commented during an
interview, "Serious adverse events reported do
happen, but in small numbers of women being
vaccinated, and some of these events may be so rare
that they will never be directly linked to the vaccine."



Dr. Harper notes that she has received money
from both Merck and GlaxoSmithKline for consultation
about and conducting clinical trials on the HPV
vaccines. "This is a good vaccine and it is generally
safe," she said.


Vaccine Is Only Part of the Story


However, there is also another very important part
to the cervical cancer prevention story, Dr. Harper said,
and that is regular Pap tests. Even women who are
vaccinated need to have regular Pap testing, as
otherwise they are still at risk of developing cervical
cancer. And women who decide not to have the
vaccine can still protect themselves by undergoing
Pap testing.


Dr. Harper feels this message has not been
made clear to the general public and that it has been
overshadowed by what she considers to be
aggressive and inappropriate promotion of Gardasil.
As a gynecologist dealing with the general population,
her advice on the HPV vaccine is that "if you are at all
concerned, then don't have the vaccine - have regular
Pap smears and you will be equally protected from
cervical cancer."


She continued, "Whether or not to get vaccinated
with Gardasil is a personal choice by each girl/woman
and/or her parents." Each individual must weigh her
family health history and whether it may put her at any
possible risk for an adverse event that Gardasil might
trigger (not even necessarily cause). As examples, Dr.
Harper mentioned family history of motor neuron
disease or autoimmune diseases, which could affect
how the person reacts to the vaccine. She illustrated
this point by saying: "Salt does not usually kill
anybody, but for a person with congestive heart failure,
it could lead to fatal pulmonary edema, so you could
say that salt caused their death, as it was the last
straw that broke the camel's back."


Details of the Adverse-Events Reports



Gardasil is 1 of the "most heavily studied and
intensively monitored vaccines," commented John
Iskander, MD, acting director of the Immunization
Safety Office at the CDC in Atlanta, Georgia. So far the
available data suggest that it is safe, he said in an
interview, although he added that "there are no
medical products, including vaccines, that are
completely safe and effective."


"We have drawn attention to the possibly
increased risk of fainting after Gardasil, again not
saying that this is a property of the vaccine, and that
precautions should be taken to avoid injury," he
said. "But there has been nothing that has warranted
a change in the recommendation for its use."


Dr. Iskander has been heading the postlicensure
safety monitoring of the vaccine. The CDC and FDA
monitor the safety of all vaccines through the Vaccine
Adverse Event Reporting System (VAERS). This
system collects unconfirmed reports of events
occurring after vaccination, and anyone can file such a
report.


As of June 30, 2008, the VAERS system had
received 9749 reports of adverse events after Gardasil
vaccination, of which the great majority (94%) were
classified as nonserious and the remaining 6%
classified as serious.


Merck said that as of June 2008, it has distributed
more than 30 million doses of Gardasil worldwide,
including nearly 18 million doses in the United States.
The company says it cannot determine the exact
number of doses that have been administered, but,
based on private insurance claims data and a broad
estimate of public-sector use, it estimates that at least
8 million US women have received at least 1 dose.
Gardasil has been available in the United States
since June 2006.


Dr. Iskander commented that, of the 9749
adverse events reported, the 6% to 7% serious
adverse event rate for Gardasil compares with a
serious adverse event rate of about 10% to 15%
reported for all vaccines (including Gardasil) in the
VAERS system.


However, Dr. Harper counters that a direct
comparison of these percentages is an invalid metric
to use, as the population may not have been as
motivated to report less serious events in other
vaccines (eg, targeted at infants or the elderly) that
have been less actively promoted, and this could
artificially elevate the proportion of serious adverse
events reported.


The nonserious adverse event reports include
syncope, pain at the injection site, headache, nausea,
and fever. The agencies note in their statement that
fainting is common after injections and vaccinations,
especially in adolescents, and say that they have
reminded immunization providers about the
recommendation to watch individuals carefully for 15
minutes after vaccination. Falls after fainting can
cause injury and can be prevented by keeping the
individual seated during the observation period, they
add. This recommendation was added to the Gardasil
prescribing information, and so far this is the only
change that has been made to the product's labeling.
The serious adverse event reports were death,
Guillain-Barré syndrome (GBS), and thromboembolic
disorders.


Most of the individuals in whom thromboembolic
disorders have been reported already had risk factors
such as the use of oral contraceptives, which are
known to increase the risk of clotting, the agencies
comment.


Incidence of Guillain-Barré Syndrome


GBS occurs spontaneously in the general
population, and Dr. Iskander noted that there is a
baseline occurrence of this disorder among
adolescents of about 1 to 2 per 100,000 persons per
year. The CDC and FDA say the available data do not
suggest an association with the vaccine: "To date,
there is no evidence that Gardasil has increased the
rate of GBS above that expected in the population."
Dr. Iskander said more definitive data on the
incidence of GBS, as well as other adverse events,
should be available within the next few months from
the Vaccine Safety Datalink (VSD) Project. A large,
controlled study is almost complete that is comparing
a vaccinated population (360,000 doses of Gardasil)
and an unvaccinated population and looking at 9 very
specific important outcomes, including GBS, blood
clots, and seizures. "We are working feverishly to
complete this study," Dr. Iskander said, "and then we
will be able to say whether any of these events are
occurring at a higher incidence in the vaccinated
population."


With circumspection, Dr. Harper added: "It is
unlikely that there will ever be a statistically associated
relationship between peripheral neuropathies (GBS,
etc) and Gardasil because the occurrence is rare -
this does not mean that Gardasil is not involved in
triggering these diseases; it means that we will never
have enough evidence to prove absolutely no
association in any subgroup of the population."


Dr. Harper noted that GBS has been associated
with the meningococcal vaccine Menactra (Sanofi
Pasteur). "This vaccine is no longer recommended in
Canada because the incidence of GBS after Menactra
is higher than the general Canadian population
incidence," she commented. In the United States,
promotion materials for Menactra state: "There is a
potential for an increased chance of getting Guillain-
Barré syndrome following vaccination."


The CDC recommends meningococcal vaccine
for children aged 11 to 18 years, which overlaps with
the age group that is approved to receive
Gardasil. "The administration of Menactra with
Gardasil (on the same day, different arms) is probably
not wise," Dr. Harper commented, although she
added that there is no CDC contraindication against
coadministration of multiple vaccines.


Adverse-Event Reports on Watchdog Web
Sites


The actual reports collected by VAERS have been
made available on the Web site of the watchdog
organization JudicialWatch, which obtained the
records from the FDA under the Freedom of
Information Act. A compact disc containing 8864
records was sent by the FDA on June 10, 2008.


JudicialWatch says the adverse event
reports "read like a catalog of horrors," and it
questions the safety of the vaccine, but the group also
questions its efficacy in preventing cervical cancer and
criticizes Merck's promotion of the product. "Given all
of the questions about Gardasil, the best public health
policy would be to reevaluate its safety and prohibit its
distribution to minors," it says. "In the least,
governments should rethink any efforts to mandate or
promote this vaccine for children," JudicialWatch
concludes in a special report on the vaccine,
published on its Web site on June 30, 2008. The
VAERS records of adverse events after Gardasil
vaccination on the JudicialWatch Web site have been
used by other groups to highlight concerns over safety
of the product.


Part of the problem stems from an ignorance
about the VAERS system, says Kenneth Alexander,
MD, PhD, chief of pediatric infectious disease at the
University of Chicago, in Illinois. He has acted as a
paid speaker for both Merck and GlaxoSmithKline, but
he pointed out that he has been researching HPV
since 1992, long before the vaccines came along.
"There is a lack of understanding that temporal
relationships do not prove causality," he said in an
interview. "In scientific terms, this is a very sensitive
assay, but it is entirely nonspecific. It is not designed
to pick up cause-and-effect relationships, and so it
picks up a lot of noncausal events."


Consumer Concerns Not Assuaged


Consumer concerns over safety have not been
assuaged by "reassurances from the government,"
said Barbara Loe Fisher, cofounder of the National
Vaccine Information Center (NVIC). "We have heard
reassurances about safety before - for example, with
the whole-cell pertussis (diphtheria-pertussis-tetanus
[DPT]) vaccine in the 1980s," she said, noting that this
was subsequently withdrawn and replaced by an
acellular version in the United States in the 1990s.



Ms. Fisher has a son whom she believes was
damaged by the DPT vaccine 28 years ago, and she
has worked ever since as an activist in the vaccine
safety field in various capacities, including a 4-year
stint as a consumer member of the FDA Vaccines and
Related Biological Products Advisory Committee.
The NVIC, self-billed as "America's Vaccine Safety
Watchdog," has also accessed VAERS reports and
made them available in a searchable database on its
Web site. These data show that during 2008, reports
about Gardasil have accounted for 20% to 25% of all
VAERS reports on all vaccines, Ms. Fisher said. "This
is striking, as Gardasil isn't a mandatory vaccine while
many other childhood vaccines are, but we don't know
what this means."


In addition, the NVIC has been running its own
private vaccine reaction registry for the past 26 years,
and it currently has about 140 reports on Gardasil, Ms.
Fisher said. "These include reports of injury and
death, and we are seeing a pattern of what we have
termed 'atypical collapse,' " she commented. "These
include cases where a girl suddenly passes into
unconsciousness either immediately or within 24
hours of vaccination and then revives feeling weak
and unable to speak properly or exhibiting other
neurological signs. What we are concerned about is
that girls are not aware of this possibility and could be
crossing the road or driving a car and suddenly pass
out."


Ms. Fisher also outlined concerns about how
Gardasil has been studied. She pointed out that very
few of the participants in the clinical trials were aged
11 to 12 years, which is the recommended target age
for the vaccine. The New York Times reported in 2006
that of the 20,000 trial participants, 1200 were younger
than 16 years.


Ms. Fisher added that the fact that the placebo
used was aluminum based, and so the results may
not give a true picture of the events associated with
the vaccine, and noted the lack of any prelicensure
data on administration of Gardasil simultaneously
with other vaccines, in particular the meningococcal
vaccine, which is targeted at a similar age range. She
suggested that the vaccine was recommended for
preadolescent girls prematurely.


"A lot of people reading these VAERS reports are
shaking the pepper shaker to try to find salt," Dr.
Alexander told Medscape Oncology. He is especially
concerned that a small number of people, and he
mentioned specifically JudicialWatch and the
NVIC, "may have another agenda and may have an
axe to grind."


Dealing With Safety Concerns Is Part of
Patient Education


Dealing with concerns over safety is part of
patient education, although it can become "a little
onerous to explain all of the time," said Kevin Ault, MD,
associate professor of gynecology and obstetrics at
Emory University, in Atlanta, Georgia, and with the
Winship Cancer Institute. He has been administering
Gardasil to the "catch-up" population at the university
clinic and said that by the time he sees these young
women, they have usually already decided that they
want the vaccine, but even so, there are lots of
questions about safety, some which are unfounded.
For example, he has been surprised at how many
times he has been asked about mercury in vaccines
and autism (after publicity over the measles-mumps-
rubella vaccine) and has had to explain that no
vaccine in the US now contains mercury and that,
anyway, autism is not a risk for an individual in their
20s.


There has been a steady, low-level rate
of "agitation" over the safety question for about a year
now, Dr. Ault told Medscape Oncology in an interview,
but he has not noticed any increase over the past
month or so. His position is that the data available so
far show that the vaccine is safe; the serious adverse
events that have been reported are very rare, and there
has been no consistent association between the
vaccine and any particular serious adverse event. "It
comes down to patient education," he said.


Improving the Health of Young People



Dr. Alexander said that reassuring about safety is
only part of the story, and educating about the benefits
of HPV vaccination is very important. He is a strong
advocate for HPV vaccination: "Do I think this is going
to prevent people from dying from cervical cancer?
Absolutely.


"In the end, we all want to improve the health of
our young people," Dr. Alexander commented. "The
question is, is HPV immunization a good way to do it?
From my perspective, we have the proven benefits that
these vaccines prevent HPV infections and cervical
precancers. These real and proven benefits of HPV
immunization must be balanced against the potential
but rare and entirely unproven associations of the
vaccine with serious adverse effects. As I add things
up, the proven benefits far, far outweigh the
theoretical, rare, and unproven risks."


However, Dr. Harper said: "In developed
countries where Pap screening systems have been
effective for decades, the biggest value of the HPV
vaccine will not be in preventing deaths from cervical
cancer. The true value of the HPV vaccine will be to
provide women with a greater reassurance that their
future Pap screens will more likely be normal.


"Pap screening is still the only proven method we
have for cervical cancer prevention," Dr. Harper
pointed out. "We don't know how long the vaccine will
protect a woman from HPV infection, and the vaccine
does not protect against all types of HPV infection that
cause cervical cancer." She said that the data so far
show that vaccination is effective for 5 years, but it is
still unknown whether boosters may be needed.
Gardasil protects against 4 types of HPV, 2 of which
are responsible for about 70% of cervical cancer, and
the other 2 for about 90% of genital warts.


"In the end, regardless of whether a woman
chooses to be vaccinated or not, the take-home
message is to start and continue Pap screening
throughout your life," Dr. Harper said.










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