“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.”

Barbara Loe Fisher, President and co-founder of the National Vaccine Information Center (NVIC):

The Gardasil Marketing campaign is one of egregious deception. With its catchy tune and wholesome images, mothers and Doctors who don’t take the time to do their own research are drawn into a misleading, intricately drawn lie. Merck has come up with a billion dollar fix to a non-existent problem. Cervical cancer is no longer a clear and present danger to modern teenagers with access to normal preventative health care and PAP tests. We are putting a generation of young women at risk and ‘playing dice’ with the reproductive future of our nation.  The FDA, CDC and a raft of either uncaring, or simply corrupt, political hacks are taking Merck’s money and looking the other way, while an unsafe drug and a flawed medical hypothesis are irreparably harming our girls and bankrupting public health care coffers.

While the FDA and CDC refuse to take action, well-meaning mothers are being deceived into thinking the Gardasil HPV vaccination  will protect their daughters from cervical cancer, and some of them are now wondering HOW and WHY their young child died or became suddenly paralyzed.

Another GARDASIL VICTIM’S Story

A month after 13 year old Jenny Tetlock was vaccinated against the HPV virus, she missed the lowest hurdle in gym class. It was the first sign of a degenerative muscle disease that 15 months later left her nearly completely paralyzed.

Her father, Philip Tetlock, a professor at UC-Berkeley, has embarked on an odyssey to find out whether the vaccine, Gardasil, is to blame.

Tetlock is not the only one concerned. The public watchdog group Judicial Watch has been periodically obtaining adverse event reports on Gardasil from the FDA. 10 deaths have been linked to Gardasil since September 2007, and there have been 140 reports so far this year of serious side effects such as miscarriage and Guillain-Barré syndrome.

Sources:

A Judicial Watch Special Report: Examining the FDA’s HPV Vaccine Records June 30, 2008

©2012 An Inconvenient Woman. All Rights Reserved.

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 Gardasil 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 (www.nvic.org) 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.

©2012 An Inconvenient Woman. All Rights Reserved.

FDA for Fast Tracking Licensure

NVIC Press Release

June 27, 2006

MERCK’S GARDASIL VACCINE NOT PROVEN SAFE FOR LITTLE GIRLS
National Vaccine Information Center Criticizes
FDA for Fast Tracking Licensure

Washington, D.C. – The National Vaccine Information Center (NVIC) is calling on the CDC’s Advisory Committee on Immunization Practices (ACIP) to just say “no” on June 29 to recommending “universal use” of Merck’s Gardasil vaccine in all pre-adolescent girls. NVIC maintains that Merck’s clinical trials did not prove the human papillomavirus (HPV) vaccine designed to prevent cervical cancer and genital warts is safe to give to young girls.

“Merck and the FDA have not been completely honest with the people about the pre-licensure clinical trials,” said NVIC president Barbara Loe Fisher. “Merck’s pre and post-licensure marketing strategy has positioned mass use of this vaccine by pre-teens as a morality play in order to avoid talking about the flawed science they used to get it licensed. This is not just about teenagers having sex, it is also about whether Gardasil has been proven safe and effective for little girls.”

The FDA allowed Merck to use a potentially reactive aluminum containing placebo as a control for most trial participants, rather than a non-reactive saline solution placebo.[1] A reactive placebo can artificially increase the appearance of safety of an experimental drug or vaccine in a clinical trial. Gardasil contains 225 mcg of aluminum and, although aluminum adjuvants have been used in vaccines for decades, they were never tested for safety in clinical trials. Merck and the FDA did not disclose how much aluminum was in the placebo.[2]

Animal and human studies have shown that aluminum can cause nerve cell death [3] and that vaccine aluminum adjuvants can allow aluminum to enter the brain, [4 5] as well as cause inflammation at the injection site leading to chronic joint and muscle pain and fatigue.  [6 7] Nearly 90 percent of Gardasil recipients and 85 percent of aluminum placebo recipients followed-up for safety reported one or more adverse events within 15 days of vaccination, particularly at the injection site.[8] Pain and swelling at injection site occurred in approximately 83 percent of Gardasil and 73 percent of aluminum placebo recipients. About 60 percent of those who got Gardasil or the aluminum placebo had systemic adverse events including headache, fever, nausea, dizziness, vomiting, diarrhea, myalgia. [9 10] Gardasil recipients had more serious adverse events such as headache, gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis.

“Merck and the FDA do not reveal in public documents exactly how many 9 to 15 year old girls were in the clinical trials, how many of them received hepatitis B vaccine and Gardasil simultaneously, and how many of them had serious adverse events after being injected with Gardasil or the aluminum placebo. For example, if there were less than 1,000 little girls actually injected with three doses of Gardasil, it is important to know how many had serious adverse events and how long they were followed for chronic health problems, such as juvenile arthritis.”

According to the Merck product manufacturer insert, there was 1 case of juvenile arthritis, 2 cases of rheumatoid arthritis, 5 cases of arthritis, and 1 case of reactive arthritis out of 11,813 Gardasil recipients plus 1 case of lupus and 2 cases of arthritis out of 9,701 participants primarily receiving an aluminum containing placebo. Clinical trial investigators dismissed most of the 102 Gardasil and placebo associated serious adverse events, including 17 deaths, that occurred in the clinical trials as unrelated.

“There is too little long term safety and efficacy data, especially in young girls, and too little labeling information on contraindications for the CDC to recommend Gardasil for universal use, which is a signal for states to mandate it,” said Fisher. “Nobody at Merck, the CDC or FDA know if the injection of Gardasil into all pre-teen girls – especially simultaneously with hepatitis B vaccine – will make some of them more likely to develop arthritis or other inflammatory autoimmune and brain disorders as teenagers and adults. With cervical cancer causing about one percent of all cancer deaths in American women due to routine pap screening, it was inappropriate for the FDA to fast track Gardasil. It is way too early to direct all young girls to get three doses of a vaccine that has not been proven safe or effective in their age group.”

The National Vaccine Information Center (NVIC), founded in 1982 by parents of vaccine injured children, has been a leading critic of one-size-fits-all mass vaccination policies and the lack of basic science research into biological mechanisms and high risk factors for vaccine-induced brain and immune system dysfunction.  As a member of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC), Barbara Loe Fisher urged trials include adequate safety data on pre-adolescent children and warned against fast tracking Gardasil at the November 28-29, 2001 VRBPAC meeting .

Full 2001 FDA Transcript: http://www.fda.gov/ohrms/dockets/ac/cber01.htm#Vaccines & Related Biological

For more information go to www.NVIC.org.

-end-

1. Merck & Co., Inc. 2006. Gardasil [Quadrivalent Human Papillomavirus Types 6,11,16,18) Recombinant Vaccine] product insert. Table 6.
2. Food and Drug Administration. May 18, 2006. FDA Background Document for Vaccines and Related Biological Products Advisory Committee: Gardasil HPV Quadrivalent Vaccine.
3. Kawahara M et al. 2001. Effects of aluminum on the neurotoxicty of primary cultured neurons and on the aggregation of betamyloid protein. Brain Res. Bull. 55, 211-217.
4. Redhead K. et al. 1992. Aluminum-adjuvanted vaccines transiently increase aluminum levels in murine brain tissue. Pharmacol. Toxico. 70, 278-280.
5. Sahin G. et al. 1994. Determination of aluminum levels in the kidney, liver and brain of mice treated with aluminum hydroxide. Biol. Trace. Elem. Res. 1194 Apr-May;41 (1-2):129-35.
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 eta la. 2005. Macrophagic myofastitis associated with vaccine derived aluminum. MJA, 183 (03):145-146.
8. Merck & Co. May 18, 2006. Merck briefing document for Vaccines and Related Biological Products Advisory Committee: Gardasil. Table 24.
9. Merck & Co., Inc. 2006. Gardasil product insert: Serious Adverse Experiences.
10. Food and Drug Administration. May 18, 2006. FDA Background Document for Vaccines and Related Biological Products Advisory Committee.: Gardasil. Table 32.
11. Food and Drug Administration. November 29, 2001. Vaccines and Related Biological Products Advisory Committee. Excerpt from transcript.

Where Do Inconvenient Women Go to Learn More

I do my best to site every one of my sources. I read hundreds of newsletters, RRS feeds, periodicals, articles and emails from other “Inconvenient Women each week. One of my favorite Inconvenient Women is Barbara Loe Fisher, Co-Founder of National Vaccine Information Center (NVIC)

“If the State can tag, track down and force citizens against their will to be injected with biologicals of unknown toxicity today, there will be no limit on which individual freedoms the State can take away in the name of the greater good tomorrow.”

— Barbara Loe Fisher, Co-Founder and President of the National Vaccine Information Center Complete Bio

The National Vaccine Information Center (NVIC) is a national, non-profit educational organization founded in 1982. The oldest and largest consumer organization advocating the institution of vaccine safety and informed consent protections in the mass vaccination system, NVIC is responsible for launching the vaccine safety and informed consent movement in America in the early 1980′s.

The Mission of The National Vaccine Information Center (NVIC) is dedicated to the prevention of vaccine injuries and deaths through public education and to defending the informed consent ethic. As an independent clearinghouse for information on diseases and vaccines, NVIC does not promote the use of vaccines and does not advise against the use of vaccines. We support the availability of all preventive health care options, including vaccination, and the right of consumers to make educated, voluntary health care choices.

NVIC provides assistance to those who have suffered vaccine reactions; promotes research to evaluate vaccine safety and effectiveness, as well as to identify factors which place individuals at high risk for suffering vaccine reactions; and monitors vaccine research, development, regulation, policy-making and legislation. NVIC works to protect the right of citizens to exercise the human right to informed consent to medical interventions which carry a risk of injury or death for themselves or their children, including vaccination.

©2012 An Inconvenient Woman. All Rights Reserved.