[NVIC] GARDASIL Vaccine: The Damage Continues

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> NVIC Vaccine E-Newsletter

> August 13, 2008

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> GARDASIL Vaccine: The Damage Continues

>

> by Barbara Loe Fisher

>

> w ww.vaccineawakening.blogspot.com

> www.NVIC.org

> www.Stand UpBeCounted.org

>

> The vaccine reaction reports keep coming into the National Vaccine

> Information Center (NVIC) 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 (Search HPV4 at

> http://www.medalerts.org/vaersdb/index.html) 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 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 zon, a New York softball player,

> snowboarder and honor roll student who dropped dead within 48 hours

> 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, 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

> 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. " 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. " - 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

>

> " zon, 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, . 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, , 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 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. " -

> 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

>

> " 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, 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. " spent

> five days in the hospital...... , 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.

> 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.

> 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. 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 , CBS News 11 -

> Dallas (July 21, 2008) http://cbs11tv.com/health/Gardasil.ce

> rvical.cancer.2.776277.html

>

> " 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

>

>

>

>

> 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

>

>

> ...

>

> TRAGIC: zon 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.

>

> zon, 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, .

>

> 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, , 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 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 .

>

> They have found " no pattern or connection " to Gardasil in eight

> deaths and are still reviewing three, he said.

>

> zon 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 , 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 zon Memorial Fund to award

> scholarships to her classmates.

>

>

> Adverse Reactions Reported After Gardasil Shots

>

> CBS 11 News (Dallas)

> Ginger , Reporting

>

> July 21, 2008

> http://cbs11tv.com/health/Gardasil.ce rvical.cancer.2.776277.html

>

> 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 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, , 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! "

>

> 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, 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. "

>

> spent five days in the hospital.

>

> Before the Gardasil vaccine, 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, " 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

> '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.

>

> , 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.

>

> 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.

>

> 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.

>

> 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

>

> 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 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 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 [GlaxoKline],

> 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

> GlaxoKline 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 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 , 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 GlaxoKline, 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. 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 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. 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. 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.

>

>

>

>

> National Vaccine Information Center

>

> NVIC E-News is a free service of the National Vaccine Information

> Center and is supported through donations.

>

> NVIC is funded through the financial support of its members and

> does not receive any government subsidies. Barbara Loe Fisher,

> President and Co- founder.

>

> Learn more about vaccines, diseases and how to protect your

> informed consent rights www.nvic.org

>

>

>

>

>

>

>

>

>

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