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.
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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
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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.
