[back] Gardasil

Dear PROVE Members,
On Thursday, June 29th, the Advisory Committee on Immunization Practices(ACIP) issued a unanimous decision to recommend vaccinating all preteen (11 and 12 year old) girls with multiple doses of the new HPV vaccine. 

Many months prior to the vote, those in favor of the vaccine had mounted an impressive but dangerous distraction campaign of focusing the media on the "morality" issues of the vaccine to distract and suppress public debate on the very real outstanding safety and efficacy questions. 

The following excellent objection to giving adolescent girls the HPV vaccine "Gardasil" is written by a Texas Board Certified Obstetrician Gynecologist who is also the father of vaccine injured children.  Share this with family, friends, and especially your health providers so they can look at this objectively instead of under the influence of the marketing by the manufacturer who is now poised to make billions of dollars without any responsibility for the harm they may cause.  Remember - everytime ACIP puts a new vaccine on the schedule, it invokes IMMUNITY FROM LIABILITY FOR THE VACCINE MANUFACTURER - parents won't be able to file a lawsuit against MERCK for the injuries and health problems this vaccine may cause their daughter.

Additionally, another very well written piece outlining even more concerns on the HPV vaccine was put out by the National Vaccine Information Center and can be read on their site at http://www.nvic.org/PressReleases/pr62706gardasil.htm or appended below.

Together, these two pieces ought to make parents really think about whether or not they want this shot given to their daughter.  Please pass this on.

OBGYN Against ACIP HPV Vaccine Decision

I am a Board Certified Obstetrician Gynecologist and have several objections to the ACIP "recommendations".

Most of the following is taken directly form the Gardasil package insert.

First, the endpoint is the prevention of "High Grade disease", this encompasses CIN II-III and adenocarcinoma in situ (AIS) which are "immediate and necessary precursors" for squamous cell and adenocarcinoma of the cervix.  The MAXIMUM of the median follow up in any of their studies is FOUR years.  However, the time course from CIN III to invasive cancer averages between 8.1 to 12.6 years.  Claiming this vaccine "prevents cervical cancer", with the longest median study subject being 4 years, is ludicrous. 

Furthermore, the vast majority of women clear or suppress the virus to levels not associated with CIN II or III and for most women this occurs promptly.  The duration of HPV positivity (which is directly related to the likelihood of developing a high grade lesion or cervical cancer) is shorter, and the likelihood of clearance is higher, in younger women.

Therefore, vaccinating these children against HPV with a vaccine that is of unknown duration of efficacy will only postpone their exposure to an age which they are less likely clear the infection on their own and be subject to more severe disease.  This would require an unknown number of boosters and is a setup for complacency in the older population that is a recipe for disaster.  Furthermore, the likelihood for regression to a normal pap from CIN II is 40%.  This beats Gardasil's "best" reduction of CIN II-III of only 12%.  In this case, "first do no harm" rules.

Furthermore the vaccine only "protects" against 4 high risk HPV subtypes.  We are currently screening for 13 "high risk" HPV subtypes. This may lead to an increase in infection with other and possibly more aggressive subtypes.

The study of the vaccine in children and adolescents is limited to only measuring the development of antibodies to the HPV subtypes in the vaccine.  There is absolutely no evidence that the vaccine prevents anything when administered at this young age.  Merck expects you to extrapolate their adult data to the immune response in children.  If they were really interested in vaccine efficacy in children, should it not be studied properly in children?

Currently, precancerous lesions are readily identifiable and treatable in the developed world.  The only utility of this vaccine may be in third world countries in which regular screening is not available and cervical cancer is still a major cause of morbidity and mortality.  All of the data reported and advertised by Merck is based on world wide morbidity and mortality related to cervical cancer.  Nowhere will you find specific data related to developed nations.

I have personally witnessed the devastation caused by severe vaccine reaction, including patients, their children, nurses and my own family.  To proceed with mass vaccination against this embellished "threat" is irresponsible.

Clayton Young, M.D., F.A.C.O.G.


for immediate release
June 27, 2006

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 .[11]

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

For more information go to www.NVIC.org.

Dawn Richardson
PROVE(Parents Requesting Open Vaccine Education)
prove@vaccineinfo.net (email)
http://vaccineinfo.net/ (web site)
PROVE provides information on vaccines, and immunization policies and practices that affect the children and adults of Texas.  Our mission is to prevent vaccine injury and death and to promote and protect the right of every person to make informed independent vaccination decisions for themselves and their family.
This information is not to be construed as medical OR legal advice.
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