Fw: NVIC] GARDASIL Vaccine: The Damage Continues

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-----Forwarded Message----- From: NVIC Sent: Aug 13, 2008 9:56 AM putney1963@... Subject: NVIC] GARDASIL Vaccine: The Damage Continues

NVIC Vaccine E-Newsletter

August 13, 2008

GARDASIL Vaccine: The Damage Continues

by Barbara Loe Fisher

w ww.vaccineawakening.blogspot.comwww.NVIC.orgwww.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 PostJuly 20, 2008By 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, 2008http://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 StoryHowever, 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 SyndromeGBS 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 SitesThe 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 AssuagedConsumer 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 EducationDealing 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.

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