Posted: 7/14/2009 9:00:00 PM
| with 65 comments
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.1
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.
Gardasil vaccine was fast tracked to licensure by the Food and Drug Administration in 2006.2
It contains genetically engineered virus-like protein particles (VLPs) and aluminum, 3,4,5
which affect immune function. 6,7,8
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.10
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.11
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.13
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.14
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.15
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.17
In 2008, the global sales from Gardasil topped $2 billion dollars.18
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.19,20,21
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.22
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.23,24,25
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.26,27,28
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.29,30,31,32,33
Fewer than 10 percent, perhaps only one percent of all serious health problems following vaccination are ever reported to U.S. federal health agencies.34,35
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.36,37
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.”38
(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.39,40,41
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?42,43
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.44
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:
numbness & tingling
pain & weakness
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),45
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.46
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.47
Empower yourself with information and take action now so we can stop girls like Gabrielle from becoming one more vaccine reaction statistic.
1 NVIC. “Gardasil & The Damage Done - Gabrielle”
2 VRBPAC. Background Document: Gardasil HPV Quadrivalent Vaccine. May 18, 2006.
3 BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets: HPV Vaccine, rDNA/Merck.
4 FDA. Gardasil (Human Papillomavirus Vaccine) Questions & Answers: What Is A Recombinant Vaccine?
5 Ruiz W, McClements WL et al. Kinetics and isotype profile of antibody responses in rhesus macaques induced following vaccination with HPV 6, 11, 16 and 18 L1-virus-like particles formulated with or without Merck aluminum adjuvant. J Immune Based Ther Vaccines. 2005; 3: 2.
6 Gherardi M et al. 2001. Macrophagaic myofastitis lesions assess long-term persistence of vaccine-derived aluminum hydroxide in muscle. Brain, Vol 124, No. 9, 1821-1831.
7 Shingde M et al. 2005. Macrophagic myofastitis associated with vaccine derived aluminum. MJA, 183 (03):145-146.
8 Lenz P,Day PM et al. Papillomavirus-Like Particles Induce Acute Activation of Dendritic Cells.The Journal of Immunology, 2001, 166: 5346-5355.
10 Merck & Co., Inc. 2006, 2008. Gardasil Quadrivalent Human Papillomavirus Types 6,11,16,18) Recombinant Vaccine product insert
11 MedAlerts: U.S. Government VAERS Database. HPV4Vaccine.
12 NVIC. June 27, 2006 Press Release: Merck’s Gardasil Not Proven Safe for Little Girls.
13 Pettypiece S, Zimm A. Merck Stops Campaign to Mandate Gardasil Vaccine Use (Update 3). Bloomberg News. Feb. 20, 2007.
14 Shots, Etc.
15 CDC. Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP): Concomitant Administration of HPV Vaccine with Other Vaccines; Simultaneous Administration with Other Vaccines. MMWR. Mar. 12, 2007/56; 1-24.
16 Medical News Today. Gardasil Debate Shifts as Merck Pushes for Use in Boys. Mar. 27, 2009.
17 CBS News. Cervical Cancer Vaccine – For Boys? Drugmaker Merck Seeks to Expand Market for Anti-SD Injection Gardasil. Jan. 6, 2009.
18 Reports-Research.com. Datamonitor: Merck & Co. – Gardasil shows promise in older women. June 15, 2009.
19 CDC. Genital HPV Infection Fact Sheet.
20 Rousseau MC, Franco EL et al. A cumulative case-control study of risk factor profiles for oncogenic and non-oncogenic cervical human papillomavirus infections. Cancer Epidemiology Biomarkers & Prevention. Vol. 9; 469-476. May 2000.
Rutgers University. HPV: Diagnosis & Treatment of Genital Human Papillomavirus Infection.
22 Saskow D, Runowicz CD et al. American Cancer Society Guidelines for the Early Detection of Cervical Neoplasia and Cancer. CA Cancer J Clin 2002; 52:342
23 Hill, M. More than 650,000 Cancer Deaths Avoided. WebMD Health News. May 27, 2009.
24 CDC. Cervical Center Statistics.
25 American Cancer Society. Cancer Facts & Figures. 2005.
26 Springen K. The Fast Track. Newsweek. August 20, 2008.
27 Merck & Co., Inc. 2006, 2008. Gardasil Quadrivalent Human Papillomavirus Types 6,11,16,18) Recombinant Vaccine] product insert
28 National Cancer Institute, NIH. HPV Vaccines: Questions & Answers (#9: How long do the [HPV] vaccines protect against infection?)
29 Laino C.. Gardasil Linked to Nerve Disorder: Cervical Cancer Vaccines May Raise Risk of Guillain-Barre Syndrome. WebMD. April 30, 2009.
30 Kotz D. CDC Takes Closer Look at Gardasil and Paralysis. U.S. News & World Report. March 20, 2009.
31 Sutton I, Lahoria R et al. CNS demyelination and quadrivalent HPV vaccination. Mult Scler. 2009 Jan; 15(1): 116-9.
32 Reuters. Update 1- Spain halts batch of Merck’s Gardasil. Feb. 10, 2009.
TypicallySpanish.com. Valencia vaccine girls rushed back into intensive care. March 15, 2009.
33 Yahoo 7 News – Australia. Today Tonight: Gardasil side effects controversy. Dec. 7, 2007.
34 Rosenthal S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events.. Am J Public Health 1995; 85:1706-9.
35 Braun M. Vaccine adverse event reporting system (VAERS): usefulness and limitations. John’s Hopkins Bloomberg School of Public Health.
36 Myers MG, Orenstein WA, Marcuse EK. Countering Vaccine Misinformation (Transcript). American Academy of Pediatrics. 2009.
37 Fagone J. Will This Doctor Hurt Your Baby? Philadelphia Magazine. June 1, 2009.
38 FDA. Information Pertaining to Labeling Revisions for Gardasil (Reminder to Health Care Providers: 15 Minute Observation Needed After Vaccination). June 9, 2009.
39 CDC. Reports of Health Concerns Following HPV Vaccination. June 10, 2009.
40 Attkisson S. New Worries About Gardasil Safety: Vaccine Safety Group Study Shows Higher Incidence of Medical Side-Effects Than Another Vaccine. CBS Evening News. Feb. 6, 2009
41 Fisher BL, Debold V. An Analysis by the National Vaccine Information Center of Gardasil & Menactra Adverse Events Reports to the Vaccine Adverse Events Reporting System (VAERS). NVIC. February 2009.
42 ConsumerAffairs.com. “FDA Estimates Vioxx Causes 27,785 Deaths.” Nov. 4, 2004.
and “Researchers Claim Vioxx Safety Study Was Actually Marketing Plan.”
Aug. 19, 2008.
43 Loudon M. The FDA Exposed: And Interview with Dr. David Graham, The Vioxx Whistleblower. MrGreen.Biz.com. August 30, 2005.
44 NVIC Vaccine Reaction Registry. Civilian Reaction Reporting Form.
46 NVIC “Investigate Gardasil Risks Now!” Petition.
47 Fourth International Public Conference on Vaccination Oct. 2-4, 2009.
Posted: 7/14/2009 9:00:00 PM
| with 65 comments