by Barbara Loe Fisher
The summer of 2009 revealed two inconvenient truths about vaccination: first, the Gardasil vaccine is not as safe for girls as the government, medical organizations and Merck have said it is; and second, the H1N1 influenza pandemic is not as serious as health officials are telling us it is. Which means that fast tracked swine flu vaccines children will get in schools this fall may end up being more risky than getting the flu.
Doctors Question Benefits & Merck Marketing Tactics
On August 19, the Journal of the American Medical Association published two important articles written by doctors questioning whether HPV vaccine benefits outweigh the risks of recommending it for all young girls. The intellectually honest doctors publicly criticized the aggressive marketing of Gardasil vaccine by Merck and certain Merck-funded U.S. medical organizations and asked for more scientific evidence that universal HPV vaccination is necessary, safe and effective.
Bad Outcome Report After 1 In Every 1,855 Gardasil Shots
In the third article, written by government health officials, it was revealed that 1 in every 1,855 Gardasil shots is followed by a bad health outcome report to the government’s Vaccine Adverse Events Reporting System.
These bad health outcomes reported after Gardasil shots include lots of girls suddenly passing out and having seizures within minutes or hours of getting vaccinated and suffering head injuries and broken bones when they hit the floor. In fact, there is a larger than expected rate of girls passing out after getting Gardasil vaccine.
Girls Passing Out & Having Car Accidents
Back in 2007, the National Vaccine Information Center warned that many girls given Gardasil shots were losing consciousness within minutes or hours. Some girls have left doctors offices and fallen unconscious while driving and had car accidents. This brings up the little known fact that four girls who got Gardasil in Merck’s pre-licensure clinical trials died in car accidents. How many of those girls suddenly collapsed while driving?
Clearly, Gardasil vaccine should be given while girls are lying down and they should be warned that sudden collapse can occur without warning within 24 hours of getting vaccinated.
Blood Clots Reports After Gardasil
What else did the recently published government study on Gardasil reveal? Well, we now know that there is a greater than expected rate of reported blood clots in girls who get the vaccine. Some blood clots can lead to pulmonary embolism or stroke, which means the blood clot ends up in the lung or in the brain. In fact four girls have died after they developed a blood clot that traveled to the lung after Gardasil vaccination.
Most Bad Outcome Reports Merck Files FDA Can’t Analyze
But the most shocking fact in this study is that, although nearly 70 percent of all Gardasil reaction reports were filed by Merck, a whopping 89 percent of the reports Merck did file were so incomplete there was not enough information for health officials to do a proper follow-up and review of what happened to the girls who fell unconscious or had convulsions, developed blood clots or inflammation of the brain and nerves, including Guillain Barre syndrome that causes paralysis, or those who suddenly developed serious autoimmune disorders like rheumatoid arthritis, lupus and more.
There were 32 reports of Gardasil-related deaths between 2006 and the end of 2008 but only 20 of these death reports had enough information to be followed up. There are now a total of 43 deaths that have been reported. How many of those Gardasil related deaths cannot be evaluated because of incomplete information?
1986 Law Requires Reporting of Vaccine Injuries & Deaths
This is an outrage. Under the National Childhood Vaccine Injury Act of 1986, it is a federal legal requirement for any person – a doctor, nurse or any person who gives a vaccination in America – to file a report with the federal government whenever a vaccination is followed by a bad health outcome, especially a hospitalization, injury or death. Vaccine providers are NOT supposed to be notifying the vaccine manufacturer – which clearly is like flushing the vaccine reaction report down the toilet – they are supposed to be notifying the government. And health officials at the FDA and CDC are supposed to be analyzing each and every report of a serious vaccine injury or death.
Massive Underreporting of Vaccine Bad Outcomes
FDA and CDC officials admit that there is underreporting of vaccine-related bad health outcomes. In fact, some studies say that less than 10 percent or even less than 1 percent of serious vaccine adverse events are ever reported.
Closed Government Databases Used to Deny Vaccine Risks
But health officials are quick to downplay the significance of this. They tell us not to worry because the closed government databases, which the CDC operates with vaccine manufacturers and HMO’s they pay to participate in them, can be relied upon to reassure us that all those seizures and blood clots and cases of brain inflammation, paralysis, lupus and deaths in girls who get Gardasil shots are really – mostly - just a coincidence.
In 2005, the National Vaccine Information Center and other parent groups called on the CDC and FDA to open up those closed government vaccine monitoring databases to public scrutiny.
So far, most of that vaccine reaction data is still hidden from public view so it can’t be independently verified.
Will H1N1 Swine Flu Vaccine Risks Be Hidden From Public?
If the government can let vaccine manufacturers fast track Gardasil vaccine but can’t compel the drug company that makes the vaccine or doctors giving the vaccine - who are shielded from liability - to report each and every death and serious injury that follows vaccination, why should we believe anything government health officials tell us about the safety of vaccines?
Why should we believe that the experimental swine flu vaccines being fast tracked with only a few weeks of study in healthy children and adults are going to be safe and that all vaccine reactions will be reported to the government and then properly followed up?
No Way To Monitor H1N1 Swine Flu Vaccine Side Effects In Schools
It is far more likely that, when children get swine flu vaccine in schools and then get really sick or even die like the Gardasil girls, that all those bad health outcomes will be written off as a coincidence by health officials. That is, IF any reports are made to the government at all! Because few school nurses or other people giving children swine flu vaccines in the schools will be taking medical histories; or have a way to record vaccine information in children’s medical records, much less monitor children for signs of a vaccine reaction and then file a reaction report to the government.
This is not the way to run a national vaccine program. This is not what we expect from doctors in positions of authority who have accepted responsibility for protecting our individual health or the health of our nation.
Doctors & Drug Companies Shielded From Liability Ignoring the Law
In the early 1980’s, parents of DPT vaccine injured children worked very hard on getting informing, recording and reporting safety provisions of the National Childhood Vaccine Injury Act of 1986. We wanted to make sure everything was being done to help prevent vaccine injuries and deaths. Little did we know then that those safety provisions would be blown off by doctors and vaccine manufacturers shielded from liability in that law.
The federal vaccine safety provisions should be codified into every state vaccine law with legal sanctions for doctors and drug companies who fail to file a complete vaccine reaction report.
What Public Health Emergency?
And now, today, we have swine flu vaccines that are being rushed to market with even less testing that the fast tracked Gardasil vaccine had, with the justification that there is a public health emergency. What public health emergency?
As everyone knows by now, the swine flu is no more serious than the garden variety influenza that goes around every year. Just like everyone knows by now that most cervical cancer can be prevented with regular Pap screening and that the very expensive HPV vaccine is questionable at best.
Why are we letting employees working for government agencies and pharmaceutical companies stampede us into taking vaccines that may not be necessary, safe or effective and – certainly - are not properly monitored for safety after they are given to tens of millions of children and adults?
It is time to demand that government officials and drug companies stop conducting national vaccine experiments on the American people.
Come To Fourth International Public Conference on Vaccination
If you want to learn more about vaccines and how to be a vaccine safety and informed consent advocate in your community, come to the Fourth International Public Conference on Vaccination being held October 2-4, 2009 in Washington, D.C. For more information, go to http://www.nvic.org/.
Watch the video bellow:
Showing posts with label Gardasil. Show all posts
Showing posts with label Gardasil. Show all posts
Preventing Gardasil Vaccine Injuries & Deaths
by Barbara Loe Fisher
She is just 16: the intelligent, lively pretty girl from Kansas, who was a high school gymnast and cheerleader and got straight A’s until, in 2008, three Gardasil shots changed her life and she became one more Gardasil reaction statistic. Today, Gabrielle never knows when she will be back in the hospital emergency room. Diagnosed with inflammation in the brain and body, the brain seizures won’t stop. She has had strokes. The right side of her body is weakened. She is in almost constant pain. Gabi has developed lupus now. Her doctor says she could die.
Fast-Tracked Vaccine
Gardasil vaccine was fast tracked to licensure by the Food and Drug Administration in 2006. It contains genetically engineered virus-like protein particles (VLPs) and aluminum, which affect immune function. The exact mechanism of protection is unknown and the vaccine has not been evaluated for the potential to cause cancer or be toxic to the genes.
It is a vaccine that, by the summer of 2009, already caused more than 15,000 thousand reports of vaccine reactions, including more than 3,000 injuries and 48 deaths. 14 of the girls who died after getting Gardasil were under age 16 just like Gabrielle.
At the National Vaccine Information, we issued our first press release in the summer of 2006 warning parents that Gardasil had not been adequately tested in young girls before government health officials recommended that all 11 and 12 year old girls get three doses of the vaccine.12 Merck only studied Gardasil in fewer than 1200 girls under age 16 and followed them up for about two years before lobbyists tried, unsuccessfully in 2007, to get the vaccine mandated for all sixth grade girls in every state.
Expanding Multi-Billion Dollar Market: Boys Are Next
Even though Gardasil was only tested on about a thousand young girls before licensure in 2006, CDC officials told doctors to give three doses of the vaccine to millions of little girls at a cost averaging $165 per dose. Because Merck did not test Gardasil in pre-licensure clinical trials in combination with all other vaccines routinely given to pre-teen and teenage girls, the CDC suggested that safety could be assumed and directed that Gardasil be given simultaneously with other vaccines.
Now Merck is asking the FDA to license Gardasil for young boys,16 an action that will expand Merck’s market by tens of millions of dollars. In 2008, the global sales from Gardasil topped $2 billion dollars.
HPV Virus Naturally Cleared From Bodies of Most People
But what is Gardasil vaccine supposed to protect our children against? It is supposed to prevent a sexually transmitted virus called HPV. Most people, who have been sexually active, have been exposed to HPV and clear the virus from their bodies within two years without any problems and are left with permanent, lifelong immunity to the HPV strains that caused infection.
The small minority of women, who do not clear the HPV virus, can develop cervical cancer and die IF they do not get regular Pap test screening and immediate treatment of pre-cancerous cervical lesions.
Routine Pap Screening Prevents Cervical Cancer & Death
After routine Pap tests became a standard part of health care for American women in the 1960’s, deaths from cervical cancer dropped by more than 70 percent. In fact, cervical cancer represents less than two percent of all cancers diagnosed in the U.S. every year and is not among the top ten causes of cancer deaths in American women today. About 11,000 American women are diagnosed with cervical cancer every year and about 4,000 women die. Plus Merck, government officials and doctors do not know how long three shots of Gardasil will protect against HPV infection. The vaccine only contains several of the many HPV strains associated with cervical cancer and hasn’t been on the market long enough to know how well it works.
Unknown If Gardasil Prevents HPV Infection Long-Term
In fact, girls are still supposed to get Pap tests even if they have been vaccinated because nobody really knows if Gardasil will prevent HPV infection for a long time without booster shots.
So here’s the bottom line: Gardasil vaccine is supposed to prevent a sexually transmitted infection that is naturally cleared from the body within two years by the vast majority of people. Getting regular Pap tests can help prevent almost all cases of cervical cancer and death.
Treating Gabrielle’s serious Gardasil vaccine injury has cost her family and insurance company tens of thousands of dollars.
Most Vaccine Reactions Not Reported
How many more Gabrielle’s are out there? We don’t know, even though there have been many similar Gardasil reaction reports from doctors and parents in the U.S. and other countries like Spain and Australia.
Fewer than 10 percent, perhaps only one percent of all serious health problems following vaccination are ever reported to U.S. federal health agencies. This means that - instead of the more than 15,000 bad health outcomes following Gardasil vaccination that have already been reported in America – actually there could have been between 150,000 and 1.5 million adverse health events following Gardasil shots which have never been counted.
Government & Doctors Say: “It’s All A Coincidence!”
Why? Because many doctors write off Gardasil related hospitalizations, injuries and deaths as just a “coincidence” and do not report. Labeling bad things that happen after vaccination as a “coincidence” minimizes the risks of vaccination. Officials at the CDC and FDA have dismissed what happened to Gabrielle after she got her Gardasil shots as a coincidence.
In fact, they have only admitted that Gardasil can cause a sudden loss of consciousness and warn that “FDA and the CDC continue to receive reports of traumatic injuries of individuals fainting and falling after receiving Gardasil. Some who have fainted have had serious injuries from falling, which have often occurred while still in the healthcare provider’s office, and other fainting episodes resulted in motor vehicle accidents.” (This fact makes it dangerous for girls to drive alone to and from doctor’s offices where Gardasil shots are given).
But government health officials have told doctors and the American public that ALL of the other serious Gardasil reaction reports, including seizures, paralysis, brain inflammation, rheumatoid arthritis, lupus, heart attacks, blood clots, strokes and deaths in young girls and women, are just a coincidence.
All of them.
How unscientific, illogical and irresponsible. We expect a lot more from doctors in charge of making sure vaccines are safe.
What if all of the injuries and deaths associated with Vioxx had been allowed to be written off as a “coincidence” after that dangerous drug had been on the market for years?
Pharmaceutical Products Carry Risks Greater for Some
Every pharmaceutical product, including every vaccine, carries a risk of injury or death. That risk can be greater for some than others.At the not-for-profit National Vaccine Information Center, we have been operating a Vaccine Reaction Registry for nearly three decades.
The most tragic cases of vaccine injury we see are when doctors revaccinate babies, children, teenagers and adults over and over again and ignore the fact that symptoms are getting worse and worse after each dose of vaccine.
Know Gardasil Reaction Symptoms
It is so important to know how to recognize Gardasil vaccine reaction symptoms like:
fainting
seizures
numbness & tingling
pain & weakness
hair loss
rashes
extreme fatigue
other health problems
Report Vaccine Reactions to NVIC
If you or a loved one has suffered a health problem after a Gardasil shot or another vaccine, after a report has been made to the federal Vaccine Adverse Event Reporting System (VAERS), go to http://www.nvic.org/Forms/CivilianReactionPage.aspx and file a report. We won’t dismiss your report as just a coincidence. We will treat it seriously and with the respect it deserves.
On the NVIC website, you can sign learn more about HPV and Gardasil Vaccine. You can sign the “Investigate Gardasil Risks Now” petition to Congress and the Obama Administration. You can sign up for this NVIC Vaccine E-newsletter and register for the Fourth International Public Conference on Vaccination being held this Oct. 2-4, 2009 in Washington, D.C., where you can learn from vaccine experts and network with other families in your state to protect vaccine choices.
Empower yourself with information and take action now so we can stop girls like Gabrielle from becoming one more vaccine reaction statistic.
For live links to original sources for references, go to:
http://www.nvic.org/NVIC-Vaccine-News/July-2009/Preventing-Gardasil-Vaccine-Injuries-Deaths.aspx
She is just 16: the intelligent, lively pretty girl from Kansas, who was a high school gymnast and cheerleader and got straight A’s until, in 2008, three Gardasil shots changed her life and she became one more Gardasil reaction statistic. Today, Gabrielle never knows when she will be back in the hospital emergency room. Diagnosed with inflammation in the brain and body, the brain seizures won’t stop. She has had strokes. The right side of her body is weakened. She is in almost constant pain. Gabi has developed lupus now. Her doctor says she could die.
Fast-Tracked Vaccine
Gardasil vaccine was fast tracked to licensure by the Food and Drug Administration in 2006. It contains genetically engineered virus-like protein particles (VLPs) and aluminum, which affect immune function. The exact mechanism of protection is unknown and the vaccine has not been evaluated for the potential to cause cancer or be toxic to the genes.
It is a vaccine that, by the summer of 2009, already caused more than 15,000 thousand reports of vaccine reactions, including more than 3,000 injuries and 48 deaths. 14 of the girls who died after getting Gardasil were under age 16 just like Gabrielle.
At the National Vaccine Information, we issued our first press release in the summer of 2006 warning parents that Gardasil had not been adequately tested in young girls before government health officials recommended that all 11 and 12 year old girls get three doses of the vaccine.12 Merck only studied Gardasil in fewer than 1200 girls under age 16 and followed them up for about two years before lobbyists tried, unsuccessfully in 2007, to get the vaccine mandated for all sixth grade girls in every state.
Expanding Multi-Billion Dollar Market: Boys Are Next
Even though Gardasil was only tested on about a thousand young girls before licensure in 2006, CDC officials told doctors to give three doses of the vaccine to millions of little girls at a cost averaging $165 per dose. Because Merck did not test Gardasil in pre-licensure clinical trials in combination with all other vaccines routinely given to pre-teen and teenage girls, the CDC suggested that safety could be assumed and directed that Gardasil be given simultaneously with other vaccines.
Now Merck is asking the FDA to license Gardasil for young boys,16 an action that will expand Merck’s market by tens of millions of dollars. In 2008, the global sales from Gardasil topped $2 billion dollars.
HPV Virus Naturally Cleared From Bodies of Most People
But what is Gardasil vaccine supposed to protect our children against? It is supposed to prevent a sexually transmitted virus called HPV. Most people, who have been sexually active, have been exposed to HPV and clear the virus from their bodies within two years without any problems and are left with permanent, lifelong immunity to the HPV strains that caused infection.
The small minority of women, who do not clear the HPV virus, can develop cervical cancer and die IF they do not get regular Pap test screening and immediate treatment of pre-cancerous cervical lesions.
Routine Pap Screening Prevents Cervical Cancer & Death
After routine Pap tests became a standard part of health care for American women in the 1960’s, deaths from cervical cancer dropped by more than 70 percent. In fact, cervical cancer represents less than two percent of all cancers diagnosed in the U.S. every year and is not among the top ten causes of cancer deaths in American women today. About 11,000 American women are diagnosed with cervical cancer every year and about 4,000 women die. Plus Merck, government officials and doctors do not know how long three shots of Gardasil will protect against HPV infection. The vaccine only contains several of the many HPV strains associated with cervical cancer and hasn’t been on the market long enough to know how well it works.
Unknown If Gardasil Prevents HPV Infection Long-Term
In fact, girls are still supposed to get Pap tests even if they have been vaccinated because nobody really knows if Gardasil will prevent HPV infection for a long time without booster shots.
So here’s the bottom line: Gardasil vaccine is supposed to prevent a sexually transmitted infection that is naturally cleared from the body within two years by the vast majority of people. Getting regular Pap tests can help prevent almost all cases of cervical cancer and death.
Treating Gabrielle’s serious Gardasil vaccine injury has cost her family and insurance company tens of thousands of dollars.
Most Vaccine Reactions Not Reported
How many more Gabrielle’s are out there? We don’t know, even though there have been many similar Gardasil reaction reports from doctors and parents in the U.S. and other countries like Spain and Australia.
Fewer than 10 percent, perhaps only one percent of all serious health problems following vaccination are ever reported to U.S. federal health agencies. This means that - instead of the more than 15,000 bad health outcomes following Gardasil vaccination that have already been reported in America – actually there could have been between 150,000 and 1.5 million adverse health events following Gardasil shots which have never been counted.
Government & Doctors Say: “It’s All A Coincidence!”
Why? Because many doctors write off Gardasil related hospitalizations, injuries and deaths as just a “coincidence” and do not report. Labeling bad things that happen after vaccination as a “coincidence” minimizes the risks of vaccination. Officials at the CDC and FDA have dismissed what happened to Gabrielle after she got her Gardasil shots as a coincidence.
In fact, they have only admitted that Gardasil can cause a sudden loss of consciousness and warn that “FDA and the CDC continue to receive reports of traumatic injuries of individuals fainting and falling after receiving Gardasil. Some who have fainted have had serious injuries from falling, which have often occurred while still in the healthcare provider’s office, and other fainting episodes resulted in motor vehicle accidents.” (This fact makes it dangerous for girls to drive alone to and from doctor’s offices where Gardasil shots are given).
But government health officials have told doctors and the American public that ALL of the other serious Gardasil reaction reports, including seizures, paralysis, brain inflammation, rheumatoid arthritis, lupus, heart attacks, blood clots, strokes and deaths in young girls and women, are just a coincidence.
All of them.
How unscientific, illogical and irresponsible. We expect a lot more from doctors in charge of making sure vaccines are safe.
What if all of the injuries and deaths associated with Vioxx had been allowed to be written off as a “coincidence” after that dangerous drug had been on the market for years?
Pharmaceutical Products Carry Risks Greater for Some
Every pharmaceutical product, including every vaccine, carries a risk of injury or death. That risk can be greater for some than others.At the not-for-profit National Vaccine Information Center, we have been operating a Vaccine Reaction Registry for nearly three decades.
The most tragic cases of vaccine injury we see are when doctors revaccinate babies, children, teenagers and adults over and over again and ignore the fact that symptoms are getting worse and worse after each dose of vaccine.
Know Gardasil Reaction Symptoms
It is so important to know how to recognize Gardasil vaccine reaction symptoms like:
fainting
seizures
numbness & tingling
pain & weakness
hair loss
rashes
extreme fatigue
other health problems
Report Vaccine Reactions to NVIC
If you or a loved one has suffered a health problem after a Gardasil shot or another vaccine, after a report has been made to the federal Vaccine Adverse Event Reporting System (VAERS), go to http://www.nvic.org/Forms/CivilianReactionPage.aspx and file a report. We won’t dismiss your report as just a coincidence. We will treat it seriously and with the respect it deserves.
On the NVIC website, you can sign learn more about HPV and Gardasil Vaccine. You can sign the “Investigate Gardasil Risks Now” petition to Congress and the Obama Administration. You can sign up for this NVIC Vaccine E-newsletter and register for the Fourth International Public Conference on Vaccination being held this Oct. 2-4, 2009 in Washington, D.C., where you can learn from vaccine experts and network with other families in your state to protect vaccine choices.
Empower yourself with information and take action now so we can stop girls like Gabrielle from becoming one more vaccine reaction statistic.
For live links to original sources for references, go to:
http://www.nvic.org/NVIC-Vaccine-News/July-2009/Preventing-Gardasil-Vaccine-Injuries-Deaths.aspx
Gardasil Death & Brain Damage: A National Tragedy
by Barbara Loe Fisher
The tragic story of Gardasil vaccine is one that is playing out real time in the homes of trusting parents, who thought they were doing the right thing to try to make their daughters "one less," and in the 21st century cyberspace forum of public opinion as well as on television. On Feb. 6, CBS-TV Evening News released NVIC's new report on Gardasil vaccine risks. (watch VIDEO here)
Today, NVIC launched a petition and issued a national press release calling on President Barack Obama, his Administration and Congress to investigate the fast track licensure and universal use recommendation of Gardasil in 2006 and the dismissal of more than 10,000 reports of Gardasil-related reactions, injuries and deaths to the Vaccine Adverse Events Reporting System (VAERS) as a "coincidence" by federal health officials.
NVIC's latest Gardasil risk report comparing the number and severity of adverse events reported to the federal Vaccine Adverse Events Reporting System (VAERS) through November 30, 2008, reveals that death and serious health problems such as stroke, blood clots, cardiac arrest, seizures, fainting, lupus and rechallenge cases are reported three to 30 times more frequently after Gardasil vaccination than after meningococcal (Menactra) vaccination. If the deaths and serious injuries being reported after Gardasil were only a "coincidence," there would be little or no difference between the frequency and severity of vaccine-related adverse events between two vaccines if the vaccines were equally reactive and the number of doses were roughly the same.
Gardasil and Menactra vaccines were licensed within a year of each other and recommended by the CDC for universal use in 11-12 year olds. Although Menactra is given to boys and girls and has already been mandated in many states for high school and college entry, Gardasil is only given to girls and is not yet mandated. Menatra is given as one-dose series and, by February 25, 2008, the CDC reported that about 15.5 million doses of Menactra had been distributed in the U.S. Gardasil is given in a three dose series and the CDC reported that, by July 2008, about 16 million doses had been distributed in the U.S.
This means that about 15 million doses of Menactra were given to about 15 million boys and/or girls and about 16 million doses of Gardasil - if every girl got three doses - were given to about five million girls. It is individuals - not doses of vaccine - who collapse, convulse, become paralyzed, have heart attacks, develop lupus and other chronic health problems after being vaccinated. The fact that death and serious health problems are reported 3 to 30 times more frequently after Gardasil than after Menactra is highly significant and it is irresponsible for federal health officials and Merck to blow it off as unimportant.
What is sad is that the average junior high or high school student could do this VAERS analysis and come to the same conclusion. It does not take an M.D., Ph.D. or math genius to figure it out. In the hours before the CBS News report was broadcast, the best answer that Merck could come up with to address the differences between adverse events associated with Gardasil and Menactra was this:
"It's important to remember that the proven benefit of GARDASIL is that it helps prevent cervical cancer caused by the two virus types responsible for most cases of cervical cancer. Nothing is more important to Merck than the safety of our products and we carefully monitor the safety of GARDASIL on a routine basis. Experts at the FDA and CDC also continue to review data and, as recently as four months ago, said "GARDASIL continues to be safe and effective, and its benefits continue to outweigh its risks." NVIC is not a medical organization and has a long history of raising concerns about vaccines that are in direct conflict with the opinion of leading medical experts. We encourage consumers to get reliable information about the safety of vaccines from www.cdc.gov."
No, it doesn't take a doctor, health official or "medical organization" to do the math. What it takes is caring about every life - whether that life represents a baby, toddler, child, teenager, young adult, adult or senior citizen - because every life is important and nobody deserves to be written off by a drug company or government agency as an expendable casualty of public health policy.
Gabrielle, the 15 year old gymnast, honor roll student and cheerleader from Wichita, Kansas, who talks about how her health has been destroyed by Gardasil vaccine in the CBS report and in the NVIC video press release, spends most of her time at home or at doctors' offices now. A few weeks ago, her school voted her Homecoming Princess. On Saturday, she tried to go to the Homecoming dance. As she was getting dressed, she collapsed with seizures and severe abdominal pain. The medication she has been taking to try to control the seizures she developed after Gardasil vaccination caused her to develop kidney stones. She was rushed to the emergency room and hospitalized.
In the past 27 years, the stories of death and brain damage that have been reported to the National Vaccine Information Center have never changed. Whether the vaccine victims are 15 months old or 15 years old, the stories are the same: a trusting parent took a bright, healthy child to a doctor for a routine vaccination and the child was never the same again.
Gardasil vaccine was inappropriately fast tracked and licensed by the FDA and recommended by the CDC with too little attention paid to the reports of brain and immune system dysfunction that developed after vaccination in pre-licensure clinical trials. That same cavalier attitude toward Gardasil-related deaths and serious health problems, which have been experienced by many girls and young women after licensure, is inexcusable.
Americans are losing trust in pharmaceutical companies making drugs and vaccines and in federal health agencies, whose responsibility is to ensure that drugs and vaccines licensed for public use are safe, effective and necessary. If those responsible for protecting our health are not going to step up to the plate and do their jobs, then it is up to the people to do it.
At www.NVIC.org you can sign the Investigate Gardasil Vaccine Risks Now! petition, read NVIC's new report on Gardasil risks, and check out our new website that makes it easier to navigate and find information to prevent vaccine injuries and deaths.
In 2009, I have a sense of déjà vu, as the story of Gardasil vaccine plays out real time. There are striking parallels between how those operating the mass vaccination system reacted in the 1980's to persistent reports that DPT vaccine was harming more children than originally assumed and the way they are reacting now to persistent reports that Gardasil is more reactive than it was originally assumed. Assumption of safety is no substitute for proof of safety. And turning away from human suffering in order to protect the status quo is not the way to run a government that needs the trust and support of the people.
In the 18th century, Queen Marie Antoinette looked down at a starving people pleading for bread to stay alive and said "Let them eat cake." It is time for everyone in government, industry and medicine to take a different approach to persistent reports of vaccine injuries and deaths or risk metaphorically suffering the same fate that ended the monarchy in France. In the 21st century, today's peasants don't have pitchforks - they have laptops, desktops, smartphones and the internet.
The tragic story of Gardasil vaccine is one that is playing out real time in the homes of trusting parents, who thought they were doing the right thing to try to make their daughters "one less," and in the 21st century cyberspace forum of public opinion as well as on television. On Feb. 6, CBS-TV Evening News released NVIC's new report on Gardasil vaccine risks. (watch VIDEO here)
Today, NVIC launched a petition and issued a national press release calling on President Barack Obama, his Administration and Congress to investigate the fast track licensure and universal use recommendation of Gardasil in 2006 and the dismissal of more than 10,000 reports of Gardasil-related reactions, injuries and deaths to the Vaccine Adverse Events Reporting System (VAERS) as a "coincidence" by federal health officials.
NVIC's latest Gardasil risk report comparing the number and severity of adverse events reported to the federal Vaccine Adverse Events Reporting System (VAERS) through November 30, 2008, reveals that death and serious health problems such as stroke, blood clots, cardiac arrest, seizures, fainting, lupus and rechallenge cases are reported three to 30 times more frequently after Gardasil vaccination than after meningococcal (Menactra) vaccination. If the deaths and serious injuries being reported after Gardasil were only a "coincidence," there would be little or no difference between the frequency and severity of vaccine-related adverse events between two vaccines if the vaccines were equally reactive and the number of doses were roughly the same.
Gardasil and Menactra vaccines were licensed within a year of each other and recommended by the CDC for universal use in 11-12 year olds. Although Menactra is given to boys and girls and has already been mandated in many states for high school and college entry, Gardasil is only given to girls and is not yet mandated. Menatra is given as one-dose series and, by February 25, 2008, the CDC reported that about 15.5 million doses of Menactra had been distributed in the U.S. Gardasil is given in a three dose series and the CDC reported that, by July 2008, about 16 million doses had been distributed in the U.S.
This means that about 15 million doses of Menactra were given to about 15 million boys and/or girls and about 16 million doses of Gardasil - if every girl got three doses - were given to about five million girls. It is individuals - not doses of vaccine - who collapse, convulse, become paralyzed, have heart attacks, develop lupus and other chronic health problems after being vaccinated. The fact that death and serious health problems are reported 3 to 30 times more frequently after Gardasil than after Menactra is highly significant and it is irresponsible for federal health officials and Merck to blow it off as unimportant.
What is sad is that the average junior high or high school student could do this VAERS analysis and come to the same conclusion. It does not take an M.D., Ph.D. or math genius to figure it out. In the hours before the CBS News report was broadcast, the best answer that Merck could come up with to address the differences between adverse events associated with Gardasil and Menactra was this:
"It's important to remember that the proven benefit of GARDASIL is that it helps prevent cervical cancer caused by the two virus types responsible for most cases of cervical cancer. Nothing is more important to Merck than the safety of our products and we carefully monitor the safety of GARDASIL on a routine basis. Experts at the FDA and CDC also continue to review data and, as recently as four months ago, said "GARDASIL continues to be safe and effective, and its benefits continue to outweigh its risks." NVIC is not a medical organization and has a long history of raising concerns about vaccines that are in direct conflict with the opinion of leading medical experts. We encourage consumers to get reliable information about the safety of vaccines from www.cdc.gov."
No, it doesn't take a doctor, health official or "medical organization" to do the math. What it takes is caring about every life - whether that life represents a baby, toddler, child, teenager, young adult, adult or senior citizen - because every life is important and nobody deserves to be written off by a drug company or government agency as an expendable casualty of public health policy.
Gabrielle, the 15 year old gymnast, honor roll student and cheerleader from Wichita, Kansas, who talks about how her health has been destroyed by Gardasil vaccine in the CBS report and in the NVIC video press release, spends most of her time at home or at doctors' offices now. A few weeks ago, her school voted her Homecoming Princess. On Saturday, she tried to go to the Homecoming dance. As she was getting dressed, she collapsed with seizures and severe abdominal pain. The medication she has been taking to try to control the seizures she developed after Gardasil vaccination caused her to develop kidney stones. She was rushed to the emergency room and hospitalized.
In the past 27 years, the stories of death and brain damage that have been reported to the National Vaccine Information Center have never changed. Whether the vaccine victims are 15 months old or 15 years old, the stories are the same: a trusting parent took a bright, healthy child to a doctor for a routine vaccination and the child was never the same again.
Gardasil vaccine was inappropriately fast tracked and licensed by the FDA and recommended by the CDC with too little attention paid to the reports of brain and immune system dysfunction that developed after vaccination in pre-licensure clinical trials. That same cavalier attitude toward Gardasil-related deaths and serious health problems, which have been experienced by many girls and young women after licensure, is inexcusable.
Americans are losing trust in pharmaceutical companies making drugs and vaccines and in federal health agencies, whose responsibility is to ensure that drugs and vaccines licensed for public use are safe, effective and necessary. If those responsible for protecting our health are not going to step up to the plate and do their jobs, then it is up to the people to do it.
At www.NVIC.org you can sign the Investigate Gardasil Vaccine Risks Now! petition, read NVIC's new report on Gardasil risks, and check out our new website that makes it easier to navigate and find information to prevent vaccine injuries and deaths.
In 2009, I have a sense of déjà vu, as the story of Gardasil vaccine plays out real time. There are striking parallels between how those operating the mass vaccination system reacted in the 1980's to persistent reports that DPT vaccine was harming more children than originally assumed and the way they are reacting now to persistent reports that Gardasil is more reactive than it was originally assumed. Assumption of safety is no substitute for proof of safety. And turning away from human suffering in order to protect the status quo is not the way to run a government that needs the trust and support of the people.
In the 18th century, Queen Marie Antoinette looked down at a starving people pleading for bread to stay alive and said "Let them eat cake." It is time for everyone in government, industry and medicine to take a different approach to persistent reports of vaccine injuries and deaths or risk metaphorically suffering the same fate that ended the monarchy in France. In the 21st century, today's peasants don't have pitchforks - they have laptops, desktops, smartphones and the internet.
Gardasil Deaths, Injuries & Money
by Barbara Loe Fisher
At the same time that more Gardasil injuries and deaths are being reported every day, those promoting mass use of Gardasil are busy denying the significance of vaccine reactions while Merck is making plans to increase its market share by asking young boys to roll up their sleeves as well.
The discussion in states about whether or not Gardasil should be mandated is still taking place even though all but two state legislatures (Virginia and D.C.) rejected mandates in 2007. It makes it easier for pro- forced vaccination proponents to keep proposed Gardasil mandates on the table when the CDC insists all of the health problems, hospitalizations, injuries and deaths that have been reported to the government's Vaccine Adverse Events Reporting System (VAERS) after Gardasil vaccination are just a "coincidence."
Through the end of October 2008, the government has published a list of 9,762 Gardasil- related adverse events, including 30 deaths, that have been reported to VAERS. This number does not include the Gardasil vaccine-related health problems which have been reported to the VAERS but not yet published. It is estimated that only between one and 10 percent of all serious health problems following administration of pharmaceutical products are ever reported to the government. This gross underreporting of vaccine- related hospitalizations, injuries and deaths means that there potentially could be nearly one million health problems following Gardasil vaccination that have actually occurred since the vaccine was licensed in 2006.
But who needs to count if it is all just a "coincidence?" It is good for business to downplay the significance of vaccine reactions and so researchers associated with Glaxo Smith Kline (GSK), who are perhaps looking toward the lucrative U.S. market for GSK's new HPV vaccine (Cervarix), are doing just that.
Waiting for approval at the FDA, Cervarix contains a powerful adjuvant (ASO4) that has not been licensed for use in the U.S. That adjuvant is designed to send the immune system into overdrive. Will it also swell the numbers of VAERS Gardasil adverse events reports that can be conveniently written off as a coincidence by doctors, government and drug company officials?
When perfectly healthy, bright teenage girls and young women get an HPV vaccination and collapse, have seizures, become paralyzed, are left with crippling fatigue and joint pain or suddenly die, their mothers and fathers deserve more than a "coincidence" explanation from doctors, government health officials and vaccine manufacturers. Until the public stands up to the Big Lie and calls it for what it is, those in charge of the U.S. vaccination system will continue to get away with putting policy and profits before good science every time a new vaccine is licensed and recommended for use by millions of Americans.
VIDEO: On Gardasil deaths click here
VIDEO: On Gardasil reactions click here
VIDEO: On Gardasil reactions click here
For Facts about HPV Infection click here
"Emily Tarsell has several paintings done by her daughter, Chris, hanging throughout her Baltimore County home. Chris Tarsell was a talented and aspiring artist, but she suddenly and inexplicably died in June at the age of 21. "No one heard from her," Tarsell said. "They went into her bedroom and found her in the bed, dead." Tarsell said she learned of her daughter's death when police officers knocked on her door. "It was about, I don't know, maybe eight o'clock. I was alone, and then they told me," she said. During an autopsy, a pathologist searched for the cause of Chris's death, but found none. Her final report listed cardiac arrest, cause undetermined, Miller reported. "They could not find anything. All the tests came back negative, so it's still unknown," Tarsell said. Weeks later, a family member mentioned to Tarsell news reports about Gardasil. "My sister and I were stunned," Tarsell said...."It's basically written off as a coincidence -- not connected," said Barbara Loe Fisher, a safety watchdog for the National Vaccine Information Center. She said she is critical of the CDC, FDA and Gardasil in particular, arguing the vaccine was put on the market too fast. "You cannot have the same people who are regulating, making policy for and promoting mass use of vaccines also in charge of making sure they're safe," Fisher said. She said a big shortcoming is the VAERS reporting system. "It's a very passive, voluntary system," she said." - Jayne Miller, WBAL-TV (Baltimore), November 21, 2008) www.youtube.com/watch?v=mqZNhOclixc
"Across the country different states including Arkansas have looked at mandating gardasil for school aged girls. It's a vaccine that helps prevent certain strains of HPV, the Human Papillomavirus which is a sexually transmitted disease that can lead to cervical cancer. But do the benefits outweigh the risks? Jesalee Parsons was 13 when her mother signed off on her to get the Gardasil vaccine at school. Now nearly two years later she says she is still in pain. Jesalee says she was diagnosed with Acute Pancreatitis and since getting one only dose of Gardasil has spent close to 100 days in the hospital, and had two surgeries to remove Pseudocysts. While doctors cannot explain why she has had health problems she and her mother are convinced the vaccine is to blame....Barbara Loe Fisher--President of the National Vaccine Information Center--wants parents to be informed before they allow their daughters to get the three dose vaccine. "We are seeing girls who are collapsing and then having seizure activity when they come to consciousness, continuing seizure disorders. We are seeing arthritis, chronic fatigue, paralysis. Some of these who are going in are perfectly healthy girls going in to get this vaccine and walk out and are chronically ill." The vaccine manufactured by Merck was tested on thousands of females in clinical trials prior to being approved but Fisher says it was not studied thoroughly enough in children. ""If your read the reports you can see certainly a number of them are related to that shot. These are healthy girls, healthy women who are going in and then dying, sometimes within hours, sometimes within days of getting this injection and often the autopsy reports come back with no known cause." - KATV-11 (Little Rock), November 6, 2008 http://www.katv.com/news/stories/110 8/567520_video.html?ref=newsstory
"A study of Merck & Co Inc's cervical cancer vaccine Gardasil found that allergic reactions were uncommon and most young women can tolerate subsequent doses, Australian researchers said on Wednesday. The research involved 25 Australian girls with suspected hypersensitivity to the vaccine which was administered as part of a national immunization program to all females aged 12 to 26 in the country beginning in 2007.....Choo and colleagues noted some components of Merck's treatment -- such as aluminum salts and yeast -- have been associated with allergic reactions.." - Reuters, December 2, 2008 http://www.reuters.com/article/healthNews/idUSTRE4B 20232008 1203
"Expected sluggish sales for some top products also is playing a role. Merck predicts sales of Gardasil to be flat in 2009 at $1.4 billion to $1.6 billion, a marked slowdown from the product's first couple of years. Merck said Gardasil already has achieved a high rate of vaccinations among girls 13 to 18 years old, and indicated it would be difficult to further boost the rate in this age group. The company also is trying to increase immunizations among women 19 to 26 years old, whose vaccination rate has been lower than expected. Merck has applied for U.S. regulatory approval to market Gardasil to women up to age 45 years old, and plans to file for approval by the end of December to market the vaccine to males ages 9 to 26, for the prevention of external lesions caused by the same virus that causes cervical cancer. It's also possible Gardasil will face new competition in the U.S. next year because GlaxoSmithKline (GSK) is awaiting regulatory decision on its own cervical- cancer vaccine, Cervarix." - Peter Loftus, Dow Jones Newswire (December 4, 2008) http://money.cnn.com/news/newsfeed s/articles/djf500/200812041031DOWJONESDJONLIN E000733_FORTUNE5.htm
At the same time that more Gardasil injuries and deaths are being reported every day, those promoting mass use of Gardasil are busy denying the significance of vaccine reactions while Merck is making plans to increase its market share by asking young boys to roll up their sleeves as well.
The discussion in states about whether or not Gardasil should be mandated is still taking place even though all but two state legislatures (Virginia and D.C.) rejected mandates in 2007. It makes it easier for pro- forced vaccination proponents to keep proposed Gardasil mandates on the table when the CDC insists all of the health problems, hospitalizations, injuries and deaths that have been reported to the government's Vaccine Adverse Events Reporting System (VAERS) after Gardasil vaccination are just a "coincidence."
Through the end of October 2008, the government has published a list of 9,762 Gardasil- related adverse events, including 30 deaths, that have been reported to VAERS. This number does not include the Gardasil vaccine-related health problems which have been reported to the VAERS but not yet published. It is estimated that only between one and 10 percent of all serious health problems following administration of pharmaceutical products are ever reported to the government. This gross underreporting of vaccine- related hospitalizations, injuries and deaths means that there potentially could be nearly one million health problems following Gardasil vaccination that have actually occurred since the vaccine was licensed in 2006.
But who needs to count if it is all just a "coincidence?" It is good for business to downplay the significance of vaccine reactions and so researchers associated with Glaxo Smith Kline (GSK), who are perhaps looking toward the lucrative U.S. market for GSK's new HPV vaccine (Cervarix), are doing just that.
Waiting for approval at the FDA, Cervarix contains a powerful adjuvant (ASO4) that has not been licensed for use in the U.S. That adjuvant is designed to send the immune system into overdrive. Will it also swell the numbers of VAERS Gardasil adverse events reports that can be conveniently written off as a coincidence by doctors, government and drug company officials?
When perfectly healthy, bright teenage girls and young women get an HPV vaccination and collapse, have seizures, become paralyzed, are left with crippling fatigue and joint pain or suddenly die, their mothers and fathers deserve more than a "coincidence" explanation from doctors, government health officials and vaccine manufacturers. Until the public stands up to the Big Lie and calls it for what it is, those in charge of the U.S. vaccination system will continue to get away with putting policy and profits before good science every time a new vaccine is licensed and recommended for use by millions of Americans.
VIDEO: On Gardasil deaths click here
VIDEO: On Gardasil reactions click here
VIDEO: On Gardasil reactions click here
For Facts about HPV Infection click here
"Emily Tarsell has several paintings done by her daughter, Chris, hanging throughout her Baltimore County home. Chris Tarsell was a talented and aspiring artist, but she suddenly and inexplicably died in June at the age of 21. "No one heard from her," Tarsell said. "They went into her bedroom and found her in the bed, dead." Tarsell said she learned of her daughter's death when police officers knocked on her door. "It was about, I don't know, maybe eight o'clock. I was alone, and then they told me," she said. During an autopsy, a pathologist searched for the cause of Chris's death, but found none. Her final report listed cardiac arrest, cause undetermined, Miller reported. "They could not find anything. All the tests came back negative, so it's still unknown," Tarsell said. Weeks later, a family member mentioned to Tarsell news reports about Gardasil. "My sister and I were stunned," Tarsell said...."It's basically written off as a coincidence -- not connected," said Barbara Loe Fisher, a safety watchdog for the National Vaccine Information Center. She said she is critical of the CDC, FDA and Gardasil in particular, arguing the vaccine was put on the market too fast. "You cannot have the same people who are regulating, making policy for and promoting mass use of vaccines also in charge of making sure they're safe," Fisher said. She said a big shortcoming is the VAERS reporting system. "It's a very passive, voluntary system," she said." - Jayne Miller, WBAL-TV (Baltimore), November 21, 2008) www.youtube.com/watch?v=mqZNhOclixc
"Across the country different states including Arkansas have looked at mandating gardasil for school aged girls. It's a vaccine that helps prevent certain strains of HPV, the Human Papillomavirus which is a sexually transmitted disease that can lead to cervical cancer. But do the benefits outweigh the risks? Jesalee Parsons was 13 when her mother signed off on her to get the Gardasil vaccine at school. Now nearly two years later she says she is still in pain. Jesalee says she was diagnosed with Acute Pancreatitis and since getting one only dose of Gardasil has spent close to 100 days in the hospital, and had two surgeries to remove Pseudocysts. While doctors cannot explain why she has had health problems she and her mother are convinced the vaccine is to blame....Barbara Loe Fisher--President of the National Vaccine Information Center--wants parents to be informed before they allow their daughters to get the three dose vaccine. "We are seeing girls who are collapsing and then having seizure activity when they come to consciousness, continuing seizure disorders. We are seeing arthritis, chronic fatigue, paralysis. Some of these who are going in are perfectly healthy girls going in to get this vaccine and walk out and are chronically ill." The vaccine manufactured by Merck was tested on thousands of females in clinical trials prior to being approved but Fisher says it was not studied thoroughly enough in children. ""If your read the reports you can see certainly a number of them are related to that shot. These are healthy girls, healthy women who are going in and then dying, sometimes within hours, sometimes within days of getting this injection and often the autopsy reports come back with no known cause." - KATV-11 (Little Rock), November 6, 2008 http://www.katv.com/news/stories/110 8/567520_video.html?ref=newsstory
"A study of Merck & Co Inc's cervical cancer vaccine Gardasil found that allergic reactions were uncommon and most young women can tolerate subsequent doses, Australian researchers said on Wednesday. The research involved 25 Australian girls with suspected hypersensitivity to the vaccine which was administered as part of a national immunization program to all females aged 12 to 26 in the country beginning in 2007.....Choo and colleagues noted some components of Merck's treatment -- such as aluminum salts and yeast -- have been associated with allergic reactions.." - Reuters, December 2, 2008 http://www.reuters.com/article/healthNews/idUSTRE4B 20232008 1203
"Expected sluggish sales for some top products also is playing a role. Merck predicts sales of Gardasil to be flat in 2009 at $1.4 billion to $1.6 billion, a marked slowdown from the product's first couple of years. Merck said Gardasil already has achieved a high rate of vaccinations among girls 13 to 18 years old, and indicated it would be difficult to further boost the rate in this age group. The company also is trying to increase immunizations among women 19 to 26 years old, whose vaccination rate has been lower than expected. Merck has applied for U.S. regulatory approval to market Gardasil to women up to age 45 years old, and plans to file for approval by the end of December to market the vaccine to males ages 9 to 26, for the prevention of external lesions caused by the same virus that causes cervical cancer. It's also possible Gardasil will face new competition in the U.S. next year because GlaxoSmithKline (GSK) is awaiting regulatory decision on its own cervical- cancer vaccine, Cervarix." - Peter Loftus, Dow Jones Newswire (December 4, 2008) http://money.cnn.com/news/newsfeed s/articles/djf500/200812041031DOWJONESDJONLIN E000733_FORTUNE5.htm
CDC Gardasil Risk Report Is A Cover-up
This week the Centers for Disease Control (CDC) in association with the Food and Drug Administration (FDA) in the U.S. Department of Health and Human Services (DHHS) issued a report on Gardasil vaccine safety that amounts to a cover-up of serious reactions, including paralysis and deaths, that have been reported to the government's Vaccine Adverse Events Reporting System (VAERS).
Today (October 24, 2008), the National Vaccine Information Center issued a press release that calls on the CDC and FDA to release to the public the study design, data and names of principal investigators involved in the report maintaining that Gardasil vaccine is safe with no serious side effects. NVIC will also be calling on the newly elected President and members of Congress to remove the nation's vaccine safety monitoring system from DHHS and place it in a separate entity reporting directly to Congress.
Sadly, U.S. government officials have learned nothing in the past 26 years from parents asking for investigation of vaccination side effects and identification of individuals at higher risk for having vaccine reactions so their lives can be spared. Now, a callous disregard for human life, which has been tragically demonstrated for decades, is once again illustrated in this latest refusal to properly evaluate the risks of the newly licensed Gardasil vaccine. Why should anyone have confidence in government and drug company officials who do not bother to scientifically investigate the biological mechanisms contributing to serious reactions, injuries and deaths and why some individuals may be more vulnerable than others for suffering Gardasil reactions?
Conflicts of interest are rampant in a mass vaccination infrastructure that has the same people, who are regulating and promoting vaccines, also evaluating vaccine safety. This kind of conflict of interest cannot be tolerated. The people - and only the people being told and often forced to buy and use vaccines - can reform the system by getting involved in the democratic process and appealing to their elected officials and demanding change. Because 26 years is long enough to wait for those in government responsible for ensuring vaccine safety to do the right thing.
At the end of the day, the only way we can have the ability to place economic and political pressure on the public health system to change is to have the right to make informed, voluntary decisions about which vaccines we and our children use. The right to informed consent to vaccination or any medical intervention which carries a risk of injury or death is a human right. Anything less, as we can see from the latest whitewash of Gardasil vaccine risks by government health officials we are supposed to trust, is a threat to both individual and public health.
____________________________________________________________
BusinessWire
NVIC Says Government Denies Gardasil Risks
Vaccine Watchdog Group Calls for Transparency
WASHINGTON--(BUSINESS WIRE)--The National Vaccine Information Center (NVIC) is calling on the Centers for Disease Control (CDC) and Food and Drug Administration (FDA) to publicly release the study design, data and names of principal investigators involved in a statement this week maintaining that Gardasil vaccine is safe with no serious side effects. NVIC will also be calling on the newly elected President and members of Congress to remove the nation's vaccine safety monitoring system from the Department of Health and Human Services (DHHS) and place it in a separate entity reporting directly to Congress to restore trust in the nation's public health laws based on federal mass vaccination policies.
The CDC and FDA are alleging that the vast majority - if not all - of the approximately 9,000 HPV vaccine adverse events, including 27 deaths, reported to the federal Vaccine Adverse Event Reporting System (VAERS) are not causally related to the Gardasil vaccine based on internal analysis, including review of medical records of girls and women vaccinated in HMO's participating in the federal Vaccine Safety Datalink (VSD) Project and other closed government operated databases.
"Transparency in government is essential to trust in government and replication is the hallmark of good science," said NVIC co-founder and president Barbara Loe Fisher. "Parents of young girls and women cut down in their prime - some of them paralyzed or dead within hours or days of getting Gardasil vaccine - deserve better answers than a whitewashing of this vaccine's very serious side effects. Until there is an independent confirmation of these unverified findings by individuals and companies without financial ties to the government or industry, it is not credible."
* In June 2006 NVIC questioned the quality and quantity of Merck's pre-licensure Gardasil vaccine safety data in girls under age 16 and, in 2007, issued three reports analyzing serious Gardasil adverse events reported to VAERS;
* In 2007, Merck lobbied in many states for Gardasil vaccine mandates but failed in most;
* During 2008, about 20 percent of all vaccine adverse event reports to VAERS were related to Gardasil even though it is not a mandated vaccine like most others;
* Last week, reports that Merck's Garda sil sales are falling dramatically and are not offsetting similar declining sales of other drugs associated with safety concerns prompted Merck to lower profit projections and layoff employees.
NVIC was founded in 1982 and worked with Congress on the 1986 National Childhood Vaccine Injury Act. The non- profit watchdog group advocates for safer vaccine policies and the legal right for Americans to make informed, voluntary decisions about vaccination.
Contacts:
National Vaccine Information Center
Barbara Loe Fisher, 703-938-0342
Permalink:
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October 21, 2008
Reports of Health Concerns Following HPV Vaccination
HPV Vaccine Safety
The safety of the HPV vaccine was studied in 7 clinical trials before it was licensed. There were over 21,000 girls and women ages 9 through 26 in these clinical trials.
Since it was licensed, CDC and FDA have been closely monitoring the safety of the HPV vaccine. There are 3 systems used to monitor the safety of vaccines after they are licensed and being used in the U.S. These systems can monitor side effects already known to be caused by vaccines as well as detect rare side effects that were not identified during a vaccine's clinical trials. The 3 systems are:
* The Vaccine Adverse Event Reporting System (VAERS)--a useful early warning public health system that helps CDC and FDA detect possible side effects or adverse events following vaccination.
* The Vaccine Safety Datalink (VSD) Project--a project between CDC and 8 health care organizations to study patterns in reports detected by VAERS and determine if a vaccine is causing a side effect.
* The Clinical Immunization Safety Assessment (CISA) Network--a project between 6 academic centers in the U.S. which conduct research on adverse events that might be caused by vaccines.
Reports to VAERS Following HPV Vaccination
As of August 31, 2008, there have been 10,326 VAERS reports of adverse events following Gardasil vaccination in the United States. Of these reports, 94% were reports of events considered to be non-serious, and 6% were reports of events considered to be serious.
Based on all of the information we have today, CDC and FDA have determined that Gardasil is safe to use and effective in preventing 4 types of HPV. As with all approved vaccines, CDC and FDA will continue to closely monitor the safety of Gardasil. Any problems detected with this vaccine will be reported to health officials, healthcare providers, and the public, and needed action will be taken to ensure the public's health and safety.
Non-serious adverse event reports
VAERS defines non-serious adverse events as those other than hospitalization, death, permanent disability, and life-threatening illness.
The vast majority (94%) of the adverse events reports following Gardasil have been non-serious. Reports of non-serious adverse events after Gardasil vaccination have included fainting, pain and swelling at the injection site (the arm), headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries, which can be easily prevented by keeping the vaccinated person seated for up to 15 minutes after vaccination.
Serious adverse event reports
VAERS defines serious adverse events as adverse events that involve hospitalization, death, permanent disability, and life-threatening illness. As with all VAERS reports, serious events may or may not have been caused by the vaccine.
All serious reports (6%) for Gardasil have been carefully analyzed by medical experts. Experts have not found a common medical pattern to the reports of serious adverse events reported for Gardasil that would suggest that they were caused by the vaccine. The following is a summary of the serious adverse event reports that were submitted to VAERS between June 8, 2006 and August 31, 2008.
Guillain-Barré Syndrome (GBS)
Guillain-Barré Syndrome (GBS) has been reported after vaccination with Gardasil. GBS is a rare disorder that causes muscle weakness. It occurs in 1-2 out of every 100,000 people in their teens. A number of infections can cause GBS. There has been no indication that Gardasil increases the rate of GBS in girls and women above the rate expected in the general population, whether or not they were vaccinated.
Blood Clots
People have reported blood clots after getting Gardasil. These clots have occurred in the heart, lungs, and legs. Most of these people had a risk of getting blood clots, such as taking oral contraceptives (the birth control pill).
Deaths
As of August 31, 2008, there have been 27 U.S. reports of death among females who have received the vaccine. There was no common pattern to the deaths that would suggest that they were caused by the vaccine. Of the 27 U.S. reports:
* 3 reports were related to diabetes or heart failure
* 3 reports were related to viral illnesses or meningitis (an infection in the brain)
* 2 reports were related to drug use
* 2 reports were related to blood clots
* 5 reports are being evaluated (attempting to follow up/identify case)
* 1 report is still under review or VAERS is still waiting for additional medical records, such as an autopsy report or death certificate
* 1 report of seizure disorder (history of seizures)
* 3 reports had an unknown cause of death
* 7 reports that could not be evaluated because they did not have enough information to identify the person, or to verify that a person had died
Reports of adverse events after getting a vaccine can be submitted to VAERS by fax at 1-877-721-0366, online at https://secure.vaers.org/VaersDataEntryintro.htm , or by mail to Vaccine Adverse Event Reporting System, P.O. Box 1100, Rockville, MD 20849-1100.
GARDASIL Vaccine: The Damage Continues
by Barbara Loe Fisher
www.vaccineawakening.blogspot.com
www.NVIC.org
www.StandUpBeCounted.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 Jessica Ericzon, 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." - Jamie Colby, Fox News (July 11, 2008) SEE VIDEO at http://www.foxnews.com/video2/video08.html?maven_referralObject=2233990&maven_referralPlaylistId=&sRevUrl=http://www.foxnews.com/health/index.html
"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/07202008/news/regionalnews/my_girl_died_as_guinea_pig_for_gardasil_120737.htm
" 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.cervical.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
www.vaccineawakening.blogspot.com
www.NVIC.org
www.StandUpBeCounted.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 Jessica Ericzon, 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." - Jamie Colby, Fox News (July 11, 2008) SEE VIDEO at http://www.foxnews.com/video2/video08.html?maven_referralObject=2233990&maven_referralPlaylistId=&sRevUrl=http://www.foxnews.com/health/index.html
"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/07202008/news/regionalnews/my_girl_died_as_guinea_pig_for_gardasil_120737.htm
" 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.cervical.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
Action on Virginia "Opt-Out" GARDASIL Mandate
by Barbara Loe Fisher
Virginia Delegate Bob Marshall has introduced a bill in the Virginia state legislature which would repeal a law passed by the General Assembly last year requiring sixth grade girls to get three doses of HPV vaccine (HB 89) by October 2008. Governor Kane has indicated he will not support a repeal of the mandate. Delegate Marshall has also authored a bill to delay the HPV vaccine mandate implementation until 2011 (HB 188).
The health subcommittee of the Virginia House Health, Welfare and Institutions Committee will hear HB 89 and HB 188 this afternoon (Monday, Jan. 14). It is a possibility that the full Committee might hear the bills at a later date if they are not passed out of subcommittee.
If you are a Virginia resident and would like to contact health subcommittee members (all of whom sit on the full Committee) and make your views known, following is contact information for committee members:
Chairman, Delegate John O'Bannon deljobannon@house.state.va.us (804) 698-1073
Delegate Jeff Frederick deljfrederick@house.state.va.us (804) 698-1052
Delegate David Nutter deldnutter@house.state.va.us (804) 698-1007
Delegate Chris Peace delcpeace@house.state.va.us (804) 698-1097
Delegate Ward Armstrong delwarmstrong@house.state.va.us (804) 698-1010
Delegate Algie Howell delahowell@house.state.va.us (804) 698-1090
Delegate Lionell Spruill dellspruill@house.state.va.us (804) 698-1077
Virginia state Senator Ken Cuccinelli is working on similar legislation in the state Senate and it is important that the Senate legislation be compatible with HB 89 and HB 188. You can contact Senator Cuccinelli's office at:
EveMarie@cuccinelli.com and district37@sov.state.va.us
Virginia Governor Tim Kane signed the HPV vaccine mandate into law last year after it was revised to include an "opt-out" provision that did not require parents to claim medical or religious reasons for the "opt-out." Merck's GARDASIL vaccine is the only HPV vaccine on the market and Merck lobbied aggressively in Texas, California, New York and more than 20 states in early 2007 to push through HPV vaccine mandates. Texas Governor Rick Perry (R) issued an Executive Order in early 2007 to try to force GARDASIL to be given to sixth graders in Texas but the Texas legislature rebelled and later passed legislation over-riding the Executive Order.
Virginia and New Jersey were the only two states to vote for an HPV vaccine mandate for pre-adolescent girls and both states modified the mandate to include an "opt-out" provision.
Merck's GARDASIL has been associated with collapse episodes, seizures, Guillain Barre syndrome and other serious health problems among young girls and women since the vaccine was licensed in mid-2006. During 2007, the National Vaccine Information Center published three analyses of GARDASIL adverse events being reported to VAERS, which indicated that GARDASIL is far more reactive than methodologically flawed pre-licensure clinical trials revealed. http://www.nvic.org/Diseases/HPV/HPVHOME.htm
A quick review of GARDASIL adverse health outcomes, which Virginia girls and young women aged 5 to 26 suffered and were reported to VAERS, revealed reports of loss of consciousness, seizures/convulsions, head injuries and fractures, joint swelling, blood disorders (ITP), abnormal cervical smears, spontaneous abortions, and medical errors (5 year old given wrong vaccine). The VAERS reports also included events labeled as life threatening or causing disability.
The NVIC staff continues to receive reports from parents of young girls, as well as young adult women, living in many different states that indicate GARDASIL is causing atypical fainting/sudden collapse within several hours of vaccination, as well as other neurological events. Many of these health problems following GARDASIL are being written off as "coincidental" by nurses and physicians without any evidence the health problem would have occurred if the vaccine had not been administered.
If you would like to work in the state of Virginia on educating Virginia state legislators about vaccine safety and informed consent issues, contact NVIC at NVICinfo@gmail.com
Virginia Delegate Bob Marshall has introduced a bill in the Virginia state legislature which would repeal a law passed by the General Assembly last year requiring sixth grade girls to get three doses of HPV vaccine (HB 89) by October 2008. Governor Kane has indicated he will not support a repeal of the mandate. Delegate Marshall has also authored a bill to delay the HPV vaccine mandate implementation until 2011 (HB 188).
The health subcommittee of the Virginia House Health, Welfare and Institutions Committee will hear HB 89 and HB 188 this afternoon (Monday, Jan. 14). It is a possibility that the full Committee might hear the bills at a later date if they are not passed out of subcommittee.
If you are a Virginia resident and would like to contact health subcommittee members (all of whom sit on the full Committee) and make your views known, following is contact information for committee members:
Chairman, Delegate John O'Bannon deljobannon@house.state.va.us (804) 698-1073
Delegate Jeff Frederick deljfrederick@house.state.va.us (804) 698-1052
Delegate David Nutter deldnutter@house.state.va.us (804) 698-1007
Delegate Chris Peace delcpeace@house.state.va.us (804) 698-1097
Delegate Ward Armstrong delwarmstrong@house.state.va.us (804) 698-1010
Delegate Algie Howell delahowell@house.state.va.us (804) 698-1090
Delegate Lionell Spruill dellspruill@house.state.va.us (804) 698-1077
Virginia state Senator Ken Cuccinelli is working on similar legislation in the state Senate and it is important that the Senate legislation be compatible with HB 89 and HB 188. You can contact Senator Cuccinelli's office at:
EveMarie@cuccinelli.com and district37@sov.state.va.us
Virginia Governor Tim Kane signed the HPV vaccine mandate into law last year after it was revised to include an "opt-out" provision that did not require parents to claim medical or religious reasons for the "opt-out." Merck's GARDASIL vaccine is the only HPV vaccine on the market and Merck lobbied aggressively in Texas, California, New York and more than 20 states in early 2007 to push through HPV vaccine mandates. Texas Governor Rick Perry (R) issued an Executive Order in early 2007 to try to force GARDASIL to be given to sixth graders in Texas but the Texas legislature rebelled and later passed legislation over-riding the Executive Order.
Virginia and New Jersey were the only two states to vote for an HPV vaccine mandate for pre-adolescent girls and both states modified the mandate to include an "opt-out" provision.
Merck's GARDASIL has been associated with collapse episodes, seizures, Guillain Barre syndrome and other serious health problems among young girls and women since the vaccine was licensed in mid-2006. During 2007, the National Vaccine Information Center published three analyses of GARDASIL adverse events being reported to VAERS, which indicated that GARDASIL is far more reactive than methodologically flawed pre-licensure clinical trials revealed. http://www.nvic.org/Diseases/HPV/HPVHOME.htm
A quick review of GARDASIL adverse health outcomes, which Virginia girls and young women aged 5 to 26 suffered and were reported to VAERS, revealed reports of loss of consciousness, seizures/convulsions, head injuries and fractures, joint swelling, blood disorders (ITP), abnormal cervical smears, spontaneous abortions, and medical errors (5 year old given wrong vaccine). The VAERS reports also included events labeled as life threatening or causing disability.
The NVIC staff continues to receive reports from parents of young girls, as well as young adult women, living in many different states that indicate GARDASIL is causing atypical fainting/sudden collapse within several hours of vaccination, as well as other neurological events. Many of these health problems following GARDASIL are being written off as "coincidental" by nurses and physicians without any evidence the health problem would have occurred if the vaccine had not been administered.
If you would like to work in the state of Virginia on educating Virginia state legislators about vaccine safety and informed consent issues, contact NVIC at NVICinfo@gmail.com
One Less? Evaluating the High Cost of GARDASIL
by Barbara Loe Fisher
To view a TV news story on the HPV Vaccine controversy, click here.
The debate about whether all young girls should routinely be vaccinated with HPV vaccine continues to be a big topic of discussion in homes and doctors' offices around the country. At the same time, reports of serious reactions to Merck's HPV vaccine, GARDASIL, continue to pile up. Last month, a young 15 year old soccer player and star athlete in Kansas almost died within three hours of being injected with GARDASIL. In September, a 12 year old Florida girl who played softball and ran cross country suddenly collapsed shortly after getting a shot of GARDASIL and became paralyzed. Twenty-eight American women, who were pregnant when they were injected with GARDASIL vaccine, have miscarried their babies.
Last year at this time, Merck was giving marching orders to lobbyists and teaming up with politicians to ram school mandates for 11 year old girls to get injected with three doses of its new and very expensive HPV Vaccine, GARDASIL. Never mind that GARDASIL had only been studied in less than 1200 girls under age 16 in pre-licensure clinical trials and was not tested for safety in combination with other vaccines like meningococcal and TdaP vaccines routinely given to pre-adolescents today.
Merck failed to make the case that the only opposition to the proposed mandates was coming from parents who did not want their pre-teen daughters to get a vaccine for a sexually transmitted disease because of religious beliefs and moral convictions. NVIC argued that, beyond the moral and parental rights issues, there was a legitimate case to be made that GARDASIL should not be mandated because of outstanding product safety issues. At the end of the day, parents across the nation made it made it clear that they did not want three doses of a poorly tested vaccine for a sexually transmitted infection that cannot be acquired in the school setting to be added to school mandates that already include dozens of doses of vaccines.
The proposed HPV vaccine mandates failed in all the states in 2007 but that did not prevent GARDASIL from becoming a blockbuster new product for Merck and it does not mean that Merck and pro-forced vaccination proponents will not try again in 2008 to get laws passed requiring its use. One Wall Street guru has predicted the $300 million Merck made this year will grow to more than $4 billion. In fact, brisk GARDASIL sales was one reason why, despite the $4.85 billion the drug maker had to pay for patients injured by painkiller Vioxx, the company turned a profit in 2007.
NVIC issued three reports in 2007 analyzing GARDASIL reaction reports being filed in the federal Vaccine Adverse Events Reporting System (VAERS) by nurses, doctors and patients. To date, the FDA VAERS data reveal that more than 4,000 GARDASIL adverse events have been reported to VAERS through October 2007. Descriptions of these vaccine reaction reports can be viewed and VAERS database searches made on NVIC's website.
(Click here and here to access the GARDASIL reaction reports directly)
On August 15, 2007, NVIC wrote a letter to the Centers for Disease Control accompanied by a detailed NVIC analysis of increased GBS and other serious adverse event reports in VAERS that have occurred when GARDASIL is given at the same time with meningococcal vaccine (Menactra) asking the CDC to issue an advisory to doctors and parents to be cautious when administering GARDASIL with Menactra. The CDC quickly dismissed the significance of the increased risk of injecting GARDASIL simultaneously with Menactra and refused to alert anyone to the potential increased risk.
Now a new study, which was funded by Kaiser (CDC's research partner) and authored by researchers with financial ties to vaccine manufacturers, has been published in a medical journal in a pro-active pre-damage, damage control attempt to dismiss the serious autoimmune and other negative health outcomes following HPV vaccination as "a coincidence." Because teenagers and adult women can talk (while babies cannot), those who are in the business of hyping HPV vaccination for profit and power know they will have a much bigger problem covering up the brain and immune system damage that occurs when healthy girls and women are injected with HPV vaccine. Just like Merck tried to make opposition to HPV vaccine mandates all about sex, so public health officials and doctors promoting HPV vaccination are going to try to sweep HPV vaccine reactions under the carpet using the unscientific but convenient "coincidence" defense.
Lost in all the hype for young girls to be "One Less" is discussion of the basic facts about HPV infection in America :
* The majority of women clear the HPV virus from their bodies naturally but women with risk factors, such as HIV infection, smoking, long-time use of oral contraceptives, and co-infection with herpes simplex virus or chlamydia, are at higher risk for chronic HPV infection.
* Between 1955 and 1992, cervical cancer deaths in American women dropped by 74 percent due to routine pap smears.
* There are about 9,800 new cases of cervical cancer annually diagnosed in the U.S., which represents .007 percent out of the approximately 1,372,000 new cancer cases of all types diagnosed.
* There are about 3,700 deaths in mostly older American women annually attributed to HPV-related cervical cancer, which is about .006 percent of the approximately 570,000 cancer deaths that occur in the U.S.
* Most cervical pre-cancers develop slowly, so nearly all cervical cancers can be prevented with regular pap smear screening and prompt treatment.
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"We already are asking our children to get more than 50 doses of vaccines by age twelve!" says the National Vaccine Information Center's Barbara Loe Fisher. If you have a daughter, there maybe one more vaccine on the list. Twenty-six states and the District of Columbia have introduced legislation requiring girls, as young as eleven, to get the vaccine that could prevent the Human Papillomavirus. "As a mother you kind of want to wrap your child in bubble wrap and just protect them from anything you can." Janet Riessman says protecting her daughter, Sage, from the virus which can cause cervical cancer was an easy decision. "For me it was all prevention." But some parents and even healthcare advocates have questions about safety. Barbara Loe Fisher tells dvmMoms.com, "It was only studied on less than 1,200 girls under the age of 16." This HPV vaccine has been on the market for little over a year. There have already been more than 4,000 reported adverse reactions and at least three people have died. The FDA and the CDC say these numbers may not tell the full story. And they claim most reactions have been minor. "The 4,000 adverse events that have been reported could be just the tip of the iceberg," says Loe Fisher. She says half of those reactions were serious enough to send girls to the emergency room. She's concerned about making the HPV vaccine mandatory." - Lesli Foster, WUSA-TV , November 28, 2007
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"A Lawrence couple is furious over a new government-approved vaccine designed to prevent a type of cancer. They say it almost killed their daughter and significantly altered her life. 15-year-old Marissa Omon is an athlete. The daughter of a Nigerian soccer player she played basketball, volleyball and track, until now. Surgeons put a defibrillator inside her chest Monday night fearing her heart could stop at any moment. "HPV [vaccine] cost my daughter. It almost cost her her life," said Edem Omon. Edem Omon is convinced his healthy, athletic teenage daughter Miranda almost died because of a vaccine doctors gave her to prevent cervical cancer....Edem said he reluctantly allowed a doctor to give her the HPV vaccine. "He convinced me the drug was safe," said Edem. Less than three hours later, while practicing basketball at Free State High School, Miranda suddenly collapsed. Her heart stopped. Paramedics needed a defibrillator to revive her. Miranda was rushed to Children's Mercy where she spent several days unable to walk or talk. Doctors ran a battery of tests, CT scans, x-rays and biopsies. They could find no explanation for Miranda's sudden heart problem. They say they do not believe the HPV vaccine has anything to do with it." Larry Seward, KSHB-TV, November 13, 2007
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"Christina Bell says she had seen ads for the vaccine so after consulting with her doctor she agreed to have her 12-year-old daughter, Brittany vaccinated. Two months ago the Florida girl suddenly collapsed. Her mother says Brittany used to play softball and run cross country. Now she can't feel her legs. Kelley Dougherty of Merck tells IB News that paralysis is not one of the recognized side effects of Gardasil use and is not even on the warning label." - Jane Akre, Injuryboard.com, November 14, 2007
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"Since June 2006, when the HPV vaccine Gardasil was approved by the Food and Drug Administration, there have been 28 reported cases in which pregnant women miscarried after receiving the vaccine. Nonetheless, based on the clinical trials done prior to approval of the drug - which indicated that miscarriages among pregnant women given Gardasil were statistically consistent with miscarriages among women given placebos and in the general population - the FDA remains convinced the vaccine is safe and is not further investigating its effect on pregnant women. In May, a 24-year-old woman suffered a miscarriage, which an investigator in a report issued to the federal government said, "may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy." In July, a 17-year-old girl from Texas was unaware she was pregnant when she got her second dose of Gardasil. She miscarried, but the cause of the miscarriage hasn't been determined, according to a report. The reasons for two other miscarriages this year in Florida - one by a 16-year-old and another by a 24-year-old both - are undetermined, according to reports. But it is known that both women had Gardasil vaccinations shortly before the miscarriages." - Fred Lukas, CNS News.com, December 6, 2007
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Concerns about supposed adverse effects of vaccines seem to occur regularly. Usually the evidence for the adverse effect leading to the scare derives from some case reports rather than from trials or carefully conducted comparative studies. Spontaneous reports of suspected adverse drug reactions, including those to vaccines, remain an important source of new information for monitoring the safety of medicines. However, suspicion about an event does not demonstrate causality. Many suspected adverse drug reactions are simply coincident in time with administration of the drug or vaccine. During the next few years, there will be vaccines introduced to groups of people who have not traditionally been vaccinated. Pandemic flu vaccine may be given to age groups who have not been, in large scale, recipients of vaccines. The human papilloma virus (HPV) disease burden and the outstanding efficacy profile of the novel HPV vaccines are such that these vaccines are currently being implemented or considered for implementation in many industrialized countries......We are concerned that the large-scale implementation of HPV vaccines in industrialized countries could reactivate the vaccine-safety debates linking vaccination to autoimmune diseases. This could possibly represent a major issue for the sustainability of HPV immunization programs in industrialized countries, and consequently for their implementation in developing countries where they are most needed...." - Claire-Anne Siegrist, MD et al., Pediatr Infect Dis J. 2008;26(11):979-984 (Subscription required)
PLAY THE VIDEO - WUSA -9, WASHINGTON DC
Canadians Follow GARDASIL Money Trail
Canadians Follow GARDASIL Money Trail
by Barbara Loe Fisher
Abraham Lincoln once said "You can fool some of the people all of the time, and all of the people some of the time, but you cannot fool all of the people all of the time." It is getting increasingly difficult for multi-national pharmaceutical corporations to hide the fact that they are engaging politicians from both sides of the aisle in the US, Canada and Europe to provide them with an assured, blockbuster market for new vaccines like Merck's GARDASIL.
http://www.agoracosmopolitan.com/home/Frontpage/2007/10/29/01919.html
It doesn't seem to matter how poorly a new vaccine has been tested or how many people die or become seriously injured after it has hit the streets. Those deaths and injuries are conveniently written off by government officials as a " coincidence" and the exploitation of the people by drug companies for profit continues without a pause.
Wall Street is doing a good job keeping us up-to- date with just how much money big pharmaceutical corporations are raking in now that Congress bowed to Big Pharma pressure and pretty much removed all liability from the business of making and selling vaccines in the 1980's and, again after September 11, 2001, in the name of "national security" and "the greater good" and the admonition that "disease is just a plane ride away." Mandating every new vaccine the drug industry produces and taking away all exemptions to vaccination is another money making guarantee.
Revenue predictions for Merck are that GARDASIL profits will climb from $300 million to $4 billion over the next year. Sanofi Pasteur, another mega giant vaccine maker is growing its vaccine sector by 50 percent. "It's a great trend and I would buy Merck" advises one Wall Street guru.
http://www.thestreet.com/funds/tv-recap/10388133.html
One day enough voters will figure out that vaccinating 300 million Americans and 33 million Canadians with multiple vaccines from cradle to the grave has more to do with keeping drug companies in the money than keeping people healthy. Then the politicians, who have committed hundreds of millions of taxpayer dollars to underwrite new product rollouts for pharmaceutical companies selling vaccines while shielding them from all liability for vaccine injuries and deaths, will be looking for another job.
--------------------------------------------------------------------------------
The Stephen Harper Conservative minority government earlier this year made a decision to spend $300 million on a campaign to inoculate females nine to 13 against cervical cancer. Sounds like great leadership on a critical health issue doesn't it? The problem is that the decision appears to be motivated to financially support the U.S. Big Business Pharmaceutical interests that developed the vaccine.... The American-based National Vaccine Information Center (NVIC) had released in February 2007 a new analysis of the U.S. Federal Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck's GARDASIL) during the last six months of 2006....Judicial Watch, a U.S. government watchdog, became concerned while noting large donations to key politicians originating from Merck.... The Toronto Star recently reported that Merck Frosst Canada Ltd hired public relations giant Hill & Knowlton to push the immunization strategies using some well-connected lobbyists...." - Paul Chen, The Canadian (October 30, 2007)
"Gardasil, the human papillomavirus vaccine from Merck, is going to be huge, Cramer and stockpickr.com's James Altucher agreed. It's going from about $300 million to $4 billion in revenue over the next year, and that's just one vaccine, he said. Plus, now they're doing late-stage trials on a hepatitis-B vaccine. "I think if you want a solid 15%, maybe 20% a year for a long time, Merck is a great bet," Altucher said. "This is a re-energized Merck," Cramer said. "It's a really great Merck. It keeps going up. It keeps beating numbers, but it's still only back to where it was a couple of years ago, so I agree with you, I think there's more [room for it] to climb." When Altucher pointed out Sanofi-Aventis (SNY) , where vaccine growth was 50%, Cramer said it is another company that he likes. For years, vaccines were risky, because if something went wrong, it was only a matter of time before a company had a class-action suit against it. "So the drug companies pretty much decided there was no real money in vaccines," Cramer explained. One of the big changes the analysts didn't pick up on is that since then, the plaintiffs' bar has been beaten back, so the litigation risk of vaccines has declined. "It's a great trend and I would buy Merck," Cramer said." - The Street.com (November 2, 2007)
by Barbara Loe Fisher
Abraham Lincoln once said "You can fool some of the people all of the time, and all of the people some of the time, but you cannot fool all of the people all of the time." It is getting increasingly difficult for multi-national pharmaceutical corporations to hide the fact that they are engaging politicians from both sides of the aisle in the US, Canada and Europe to provide them with an assured, blockbuster market for new vaccines like Merck's GARDASIL.
http://www.agoracosmopolitan.com/home/Frontpage/2007/10/29/01919.html
It doesn't seem to matter how poorly a new vaccine has been tested or how many people die or become seriously injured after it has hit the streets. Those deaths and injuries are conveniently written off by government officials as a " coincidence" and the exploitation of the people by drug companies for profit continues without a pause.
Wall Street is doing a good job keeping us up-to- date with just how much money big pharmaceutical corporations are raking in now that Congress bowed to Big Pharma pressure and pretty much removed all liability from the business of making and selling vaccines in the 1980's and, again after September 11, 2001, in the name of "national security" and "the greater good" and the admonition that "disease is just a plane ride away." Mandating every new vaccine the drug industry produces and taking away all exemptions to vaccination is another money making guarantee.
Revenue predictions for Merck are that GARDASIL profits will climb from $300 million to $4 billion over the next year. Sanofi Pasteur, another mega giant vaccine maker is growing its vaccine sector by 50 percent. "It's a great trend and I would buy Merck" advises one Wall Street guru.
http://www.thestreet.com/funds/tv-recap/10388133.html
One day enough voters will figure out that vaccinating 300 million Americans and 33 million Canadians with multiple vaccines from cradle to the grave has more to do with keeping drug companies in the money than keeping people healthy. Then the politicians, who have committed hundreds of millions of taxpayer dollars to underwrite new product rollouts for pharmaceutical companies selling vaccines while shielding them from all liability for vaccine injuries and deaths, will be looking for another job.
--------------------------------------------------------------------------------
The Stephen Harper Conservative minority government earlier this year made a decision to spend $300 million on a campaign to inoculate females nine to 13 against cervical cancer. Sounds like great leadership on a critical health issue doesn't it? The problem is that the decision appears to be motivated to financially support the U.S. Big Business Pharmaceutical interests that developed the vaccine.... The American-based National Vaccine Information Center (NVIC) had released in February 2007 a new analysis of the U.S. Federal Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck's GARDASIL) during the last six months of 2006....Judicial Watch, a U.S. government watchdog, became concerned while noting large donations to key politicians originating from Merck.... The Toronto Star recently reported that Merck Frosst Canada Ltd hired public relations giant Hill & Knowlton to push the immunization strategies using some well-connected lobbyists...." - Paul Chen, The Canadian (October 30, 2007)
"Gardasil, the human papillomavirus vaccine from Merck, is going to be huge, Cramer and stockpickr.com's James Altucher agreed. It's going from about $300 million to $4 billion in revenue over the next year, and that's just one vaccine, he said. Plus, now they're doing late-stage trials on a hepatitis-B vaccine. "I think if you want a solid 15%, maybe 20% a year for a long time, Merck is a great bet," Altucher said. "This is a re-energized Merck," Cramer said. "It's a really great Merck. It keeps going up. It keeps beating numbers, but it's still only back to where it was a couple of years ago, so I agree with you, I think there's more [room for it] to climb." When Altucher pointed out Sanofi-Aventis (SNY) , where vaccine growth was 50%, Cramer said it is another company that he likes. For years, vaccines were risky, because if something went wrong, it was only a matter of time before a company had a class-action suit against it. "So the drug companies pretty much decided there was no real money in vaccines," Cramer explained. One of the big changes the analysts didn't pick up on is that since then, the plaintiffs' bar has been beaten back, so the litigation risk of vaccines has declined. "It's a great trend and I would buy Merck," Cramer said." - The Street.com (November 2, 2007)
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