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Articles : Vaccinations
  
Gardasil & Swine Flu Vaccines: Inconvenient Truths: Back to Articles
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; 1 and second, the H1N1 influenza pandemic is not as serious as health officials are telling us it is. 2 3 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. 4
 
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 5 and asked for more scientific evidence that universal HPV vaccination is necessary, safe and effective. 6
 
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. 7 8 9 Some girls have left doctors offices and fallen unconscious while driving and had car accidents. 10 This brings up the little known fact that four girls who got Gardasil in Merck’s pre-licensure clinical trials died in car accidents. 11 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. 12 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, 13 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. 14 15

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. 16 17 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 18 but can’t compel the drug company that makes the vaccine or doctors giving the vaccine - who are shielded from liability 19 - 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 20 are going to be safe and that all vaccine reactions will be reported to the government and then properly followed up? 21

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. 22
 
    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 23 with even less testing that the fast tracked Gardasil vaccine had, with the justification that there is a public health emergency. 24 25 26 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. 27Just 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. 28
 
        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.

 

1 Slade BA, Leidel L, Vellozzi C, Woo EJ et al. Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine. JAMA, August 19, 2009; Vol. 302, No.7: pp.750-757.
 
2 Morens DM, Taubenberger JK. Understanding Influenza Backwards. JAMA, August 12, 2009; Vol. 302, No. 6: pp.679-680.
 
3 Collignon P. Take a deep breath – Swine flu is not that bad. AENJ, June 1, 2009; Vol. 12, No. 3: pp. 71-72.
 
4 Macfarlane J. Swine flu jab link to killer nerve disease: Leaked letter reveals concern of neurologists over 25 deaths in America. Daily Mail (UK), August 15, 2009.
 
5 Rothman SM, Rothman DJ. Marketing HPV Vaccine: Implications for Adolescent Health and Medical Professionalism. JAMA, August 19, 2009; Vol. 302, No. 7: pp.781-786.
 
6 Haug C. The Risks and Benefits of HPV Vaccination. JAMA, August19, 2009; Vol. 302, No. 7: pp. 795-796.
 
7 Debold V, Fisher BL. HPV Vaccine Safety Analysis of VAERS Reports: Adverse Reactions, Concerns & Implications. NVIC, February 1, 2009 and additional reference.
 
8 Debold V, Fisher BL. HPV Vaccine Safety Analysis of VAERS Reports – Part II. NVIC, February 18, 2009 and additional reference.
 
9 Debold V, Downey C, Fisher BL. HPV Vaccine Safety Analysis of VAERS Reports – Part III. NVIC, August 15, 2009 and additional reference.
 
1 0 FDA. Information Pertaining to Labeling Revision for Gardasil: 15-Minute Observation Period Needed After Vaccination. June 9, 2009.
 
1 1 Merck & Co., Inc. 2006, 2008. Gardasil Quadrivalent Human Papillomavirus Types 6,11,16,18 Recombinant Vaccine Product Insert.
 
1 2 MedAlerts. HPV Vaccine Death Reports through June 30, 2009. Accessed August 23, 2009.
and Event Details Report 2 and Event Details Report 3
1 3 National Childhood Vaccine Injury Act of 1986 (PL99-660) and CDC Fact Sheet For Vaccine Information Statements
 
1 4 Braun M. Vaccine adverse event reporting system (VAERS): usefulness and limitations. Johns Hopkins Bloomberg School of Public Health.
 
 
1 5 Rosenthanl S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health 1995; 85: pp. 1706-9.
 
 
1 6 Fisher BL.Statement on National Immunization Program Procedures & Data Sharing Program. Institute of Medicine. August 23, 2004.
 


 
1 7 NVIC. Show Us the Vaccine Data Petition.
 
 
1 8 FDA. Vaccines & Related Biological Products Advisory Committee. Background Document: Gardasil HPV Quadrivalent Vaccine. May 18, 2009.
 
 
1 9 Institute of Medicine. The Children’s Vaccine Initiative: Achieving the Vision. Appendix B: National Vaccine Injury Compensation Program. 1993.
 
2 0 FDA. Vaccines & Related Biological Products Advisory Committee. Transcript of July 23, 2009 VRBPAC meeting on H1N1 influenza virus vaccines and copies of CDC, vaccine manufacturer and other presentations.
 
 2 1 Fisher, BL. Swine Flu Vaccine Should Not Be Given To Children in Schools. NVIC, July 22, 2009.
 
2 2 Fisher BL. National Vaccine Injury Compensation Program: A Failed Experiment in Tort Reform? Advisory Commission on Childhood Vaccines. November 18, 2008.
 
 2 3 DeNoon DJ. Swine Flu Vaccine Fast-Tracked to September? WebMD, July 17, 2009.

 2 4 Department of Health & Human Services Secretary Kathleen Sibelius. Determination that a Public Health Emergency Exists. April 26, 2009. And Renewal of a Determination that a Public Health Emergency Exists, July 24, 2009.
 
 
2 5 CBS News. August 12, 2009. Washington Unplugged: H1N1 Vaccine Dangers with Sharyl Attkisson, Jennifer Ashton, MD and Barbara Loe Fisher.
 
2 6 Stein R. Swine Flu Vaccine Campaign Waits On Vaccine. Washington Post, August 23, 2009.
 
2 7 Jefferson T. A Whole Industry Is Waiting for a Pandemic. Spiegel Online. July 21, 2009.
 
2 8 CBS News. August 19, 2009. Gardasil Researcher Speaks Out: “Public Should Receive More Complete Warnings.” 
 

 
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