What you need to know about Gardasil and HPV
Gardasil Researcher Drops A Bombshell
Harper: Controversal Drug Will Do Little To Reduce Cervical Cancer Rates
By Susan Brinkmann, For The Bulletin
Dr. Diane Harper, lead researcher in the development of two human papilloma virus vaccines, Gardasil and Cervarix, said the controversial drugs will do little to reduce cervical cancer rates and, even though they’re being recommended for girls as young as nine, there have been no efficacy trials in children under the age of 15.
Dr. Harper, director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, made these remarks during an address at the 4th International Public Conference on Vaccination which took place in Reston, Virginia on Oct. 2-4. Although her talk was intended to promote the vaccine, participants said they came away convinced the vaccine should not be received. Read more here.
Should the Government mandate the HPV Vaccine?
Tennessee Eagle Forum’s answer is a resounding NO!
OUTCOME OF THE BILL PROHIBITING THE MANDATING OF THE HPV VACCINE:
This certainly is not the outcome we had anticipated when the bill was introduced and we are saddened that some legislators were not willing to protect parental rights from potential government intrusion into sensitive health care decisions for their children.
HB 1580- Rep. Joey Hensley, M.D. (R-Hohenwald)
Requires the general assembly, instead of authorizing the commissioner of health, subject to the approval of the public health council, to specifically authorize an immunization for a disease only transmitted sexually, for which a preventive vaccine has been approved and recommended for girls and women in a specific age group.
It is hard to know where to start with this sad tale. Dr. Hensley presented the measure as a Parental Rights Bill, which is exactly what it is. Full Committee Chairman Rep. Joe Armstrong (D-Knoxville) who is not a member of the subcommittee, but is permitted to sit in and vote, led the charge.
If I did not know precisely what the bill actually did, I would never have suspected from what Armstrong and Rep. JoAnne Favors had to say—it was so misrepresented. Dr. Kelly Moore, Dept. of Health, was called on to testify. She commented about how wonderful the vaccine was, etc. Understand, this bill had NOTHING to say about the merits of the vaccine, it only addressed the prohibition against mandating it without coming back to the legislature for debate.
Rep. DuBois pointed out that it was good to have expert opinion, but that legislators had a responsibility to protect the fundamental rights of parents to raise their children and make health care decision for them. Dr. Moore did say that the Commissioner was not interested in mandating the vaccine now and that should any mandate be considered the rules and regulations would come back through the respective Government Operations Committees.
The ability of parents to have a voice would depend on knowing about the specific committee meeting. This legislation had 17 Senate sponsors and 40 House sponsors. Despite the outcome, we brought a lot of attention to the issue to the legislators as well as the public.
A voice vote was taken and our bill failed:
Voting YES: Reps. Chris Crider, Tom DuBois, and Debra Maggart.
Voting NO: Reps. Lois DeBerry, JoAnne Favors and Joe Armstrong
It appeared that Chairman Mary Pruitt didn’t vote one way or the other. (Sherry Jones was absent.)
You may have read that Republican Texas Governor Rick Perry recently issued an Executive Order mandating the human papillomavirus (HPV) Vaccine Gardasil (Merck) for all little girls entering the sixth grade in 2008. While there is a complicated opt-out provision, Texas parents and many legislators were stunned and furious at this over-reaching of the government into the private lives of families. Even the Texas Medical Association, the American Academy of Physicians and Surgeons and others OPPOSE the government mandating this vaccine.
Texas lawmakers have introduced legislation to countermand the Executive Order and now some parents have even filed suit against the Governor.
Merck has spent millions on slick television advertisements [see: http://www.gardasil.com/tv-commercial-for-gardasil.html] promoting this vaccine, but if you listen carefully to the ad and read their printed material, they make no promises. They have also been spending hundreds of thousands of dollars across the country to encourage states to MANDATE the vaccine for young girls. According to reports Merck spent between $150,000 and $250,000 lobbying their cause in Texas – the lobbyist being a former staff member of the Governor.
Mandating bills have been introduced in a number of states, but this blatant interference with family privacy and decision-making has created so much controversy that Merck recently announced that they would ‘back off’ of the push to mandate the vaccine.
Gardasil, at a minimum, will cost $120 per injection – three being the required course of treatment. Wall Street analysts had predicted that Gardasil is projected to generate $2 billion to $4 billion this year without state mandates. Some speculated that this profit would offset losses Merck endured after it pulled Vioxx off the market in 2004. The FDA-approved anti-inflammatory drug for osteoarthritis and acute pain was linked to increased risk of heart attack and stroke. Lawsuits are pending.
There was concern that a ‘mandate’ might be forthcoming for families in our state through an Executive Order, from a Department of Health requirement, or through legislation.
Standing in the gap for parents and families in Tennessee, we have introduced legislation that prohibits ANY mandate for this vaccine unless is it specifically authorized by the General Assembly. See information below:
SB1958 by *Finney R., *Burchett, *Tracy, *Ketron, *Crowe, *Watson, *McNally, *Norris, *Stanley, *Beavers, *Southerland. (HB1580 by *Hensley, *Bell, *Lollar, *Cobb J, *Watson , *Hawk, *Baird, *Maggart, *Todd, *Eldridge, *Strader, *Lynn, *Lundberg, *Ford, *Campfield, *Hill, *McDaniel, *Johnson P, *Mumpower, *Dean, *Casada, *Floyd, *Rowland, *Johnson C, *McCormick, *Coley, *Matheny, *Matlock, *Harrison, *Swafford, *Williams, *Dunn.)
Requires the general assembly, instead of authorizing the commissioner of health, subject to the approval of the public health council, to specifically authorize an immunization for a disease only transmitted sexually, for which a preventive vaccine has been approved and recommended for girls and women in a specific age group. - Amends TCA Section 49-6-5001
To read the bill, go to: http://www.legislature.state.tn.us/bills/currentga/BILL/SB1958.pdf
When signing on as co-sponsors, many legislators thanked TN Eagle Forum for being pro-active and taking a leadership position on this important issue of family privacy and decision making.
This bill does not address the merits of Gardasil, however, there are many concerns about the vaccine and parents should research the material provided here before making a decision to inject these powerful chemicals into the bodies of young girls just as they are about to enter puberty.
Parents should remember that HPV is a sexually transmitted disease. It is not a contagious disease like measles or chicken pox which can be caught by casual contact. Gardasil is thought to be effective for only four types of the 30 genital HPV types.
HPV vaccine being pushed for teen girls isn't all you may think it is
By BOBBIE PATRAY
Republican Texas Gov. Rick Perry set off a nationwide firestorm by issuing an executive order mandating that by the fall of 2008, all sixth-grade girls in his state be given the new Merck Gardasil vaccine for human papillomavirus (HPV), which was developed to prevent some cervical cancers. Although there is a rather involved opt-out provision, parents and legislators were furious at the government interfering with the private health-care decisions of families for their minor children.
This action coincided with Merck's expensive national television marketing campaign to promote the vaccine and the company's efforts to pass legislation mandating its use. Part of the campaign was donating generously to Women in Government (WIG) a Washington-based advocacy group composed of female legislators. Neither Merck nor WIG will reveal the amount given, however, according to the WIG website, mandating legislation has been introduced in nearly 20 states.
At a minimum price of $360 for the three injections, mandating the vaccine for a never-ending supply of sixth-grade girls would be a windfall for Merck.
It didn't take Texas lawmakers long to introduce legislation to countermand the executive order, and the parents of three Texas girls have filed a lawsuit claiming Perry's order went beyond his authority and illegally mandated the vaccine.
The Texas Medical Association and the American Academy of Physicians and Surgeons does not support the mandate, nor does Dr. Jon Abramson, chairman of the Centers for Disease Control and Prevention's advisory committee on immunization practices.
HPV is not like measles or chicken pox — easily transmitted between children in the classroom. It is a sexually transmitted disease directly connected to a specific behavior.
The incidences of cervical cancer have declined dramatically since the introduction of the PAP smear into a women's health regimen. In fact, 85 percent of those deaths could have been prevented with regular PAP smears. Gardasil materials admit that there are 30 strains of HPV that are transmitted sexually. This vaccine "may" protect from only four of those.
As the debate has continued, we have learned that most sexually active women will get HPV and their bodies will throw it off just as other viruses are thrown off. Of all the women infected with HPV, only about 3.4 percent are infected with the types that are targeted by the Gardasil.
We have no idea what pumping this drug into little girls just starting into puberty will mean in 10-15 years. There have been 82 cases of serious side effects reported; who knows how many went unreported? Infectious disease specialists say the incubation period of HPV becoming cancer is 10-15 years. This means that the average cervical cancer patient, who is 47, contracted the virus in her 30s and wouldn't be protected by this vaccine she received as a teen.
The bottom line is that parents should be very cautious and do in-depth research before deciding to give Gardasil to their daughters.
Perry orders HPV vaccine
AUSTIN – Gov. Rick Perry – usually a hero to social conservatives – surprised many of them Friday by making Texas the first state to mandate a vaccine for sixth-grade girls to prevent a sexually transmitted infection that leads to most kinds of cervical cancer.
In his executive order, Mr. Perry said girls must receive the human papillomavirus vaccine before school starts in September 2008. While noting that parents may opt out of the vaccine for conscience or religious reasons, he said it "provides us with an incredible opportunity to effectively target and prevent cervical cancer."
OBGYN Questions HPV Vaccine Gardasil
Obstetrics and Gynecology
The American College of Obstetricians and Gynecologists
I am writing in response to the recent Committee Opinion 344 Published in the September issue of Obstetrics and Gynecology. I have several concerns regarding Gardasil.
First, the Gardasil’s product insert states their 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.1 The MAXIMUM median follow up in any of their studies is FOUR years.
HPV Vaccine Mandates Risky And Expensive
Main Category: Sexual Health / STDs News
Article Date: 03 Feb 2007 - 0:00 PST
The National Vaccine Information Center (NVIC), the nation's leading vaccine safety and informed consent advocacy organization, is urging state legislatures to investigate the safety and cost of mandating Merck's HPV vaccine (GARDASIL) for all pre- adolescent girls before introducing legislation amending state vaccine laws. In an analysis of reports made to the federal Vaccine Adverse Event Reporting System (VAERS) since the CDC's July 2006 universal use recommendation for all young girls, NVIC found reports of loss of consciousness, seizures, joint pain and Guillain-Barre Syndrome. In a separate evaluation of costs for young girls being vaccinated in private pediatrician offices, NVIC discovered that parents living in the Washington, D.C. area will be paying between $500 and $900 to have their daughters receive three doses of GARDASIL.
Feb. 7, 2007, 11:46AM
Doctors say Perry's vaccine mandate for girls is premature
They hail inoculation for cancer-causing virus but cite liability, cost concerns
By TODD ACKERMAN
Copyright 2007 Houston Chronicle
Gov. Rick Perry's order requiring schoolgirls to get inoculated against a sexually transmitted virus linked to cervical cancer may be unpopular with social conservatives, but another important group also is lining up against it: doctors.
From, among others, the Texas Medical Association and the American Academy of Pediatrics, many doctors are saying it's too early to mandate the vaccine, which was approved for use last June. It protects against four strains of the human papillomavirus that cause 70 percent of cervical cancers.
The HPV Vaccine and School Mandates:
Questions and Answers – comprehensive list
Cancer-virus vaccine targets wrong age group
By Gregory Lopes and Christopher M. Dolan
THE WASHINGTON TIMES
February 21, 2007
Lawmakers looking to force preteen girls to take Gardasil, a new vaccine against a virus that causes cervical cancer, are targeting the wrong age group, cancer data shows.
Middle-school girls inoculated with the breakthrough vaccine will be no older than 18 when they pass Gardasil's five-year window of proven effectiveness -- more than a decade before the typical cancer patient contracts the sexually transmitted human papillomavirus (HPV).
Infectious disease specialists and cancer pathologists say the incubation period for HPV becoming cancer is 10 to 15 years -- meaning the average cervical cancer patient, who is 47, contracted the virus in her 30s and would not be protected by Gardasil taken as a teen.
American College of Pediatricians States Position on HPV Vaccine
The American College of Pediatricians commends the researchers, prelicensure study participants, and vaccine manufacturers for bringing the Human Papilloma Virus (HPV) vaccine to fruition. Despite the monumental contribution of Dr. George N.
Papanicolaou, who developed the “Pap” test in 1928 and published a description of its use in diagnosing uterine cancer in 1943, cervical cancer is still a major health problem for women. It is the 2nd most common cancer worldwide, and the 11th most common cancer in American women. Despite a 70% reduction in deaths from cervical cancer with the routine use of Pap smears, in 2005 it still took the lives of 3710 women in the United States, and 290,000 worldwide. While the average age of death from malignancies in general is 72 years, the average age of women dying of cervical cancer is 57 years. The cost of cervical cancer screening and treatment has been calculated to be as high as 6 billion dollars per year in the United States alone.
Currently, an HPV vaccine is approved for children and adults ages 9-26. Despite encouraging results in prelicensure studies, research definitively establishing the duration of HPV vaccine protection, degree of protection and spectrum of side effects remain to be determined.
Vaccine center issues warning
By Gregory Lopes
THE WASHINGTON TIMES
February 3, 2007
The National Vaccine Information Center yesterday warned state officials to investigate the safety of a breakthrough cancer vaccine as Texas became the first state to make the vaccine mandatory for school-age girls.
Negative side effects of Gardasil, a new Merck vaccine to prevent the sexually transmitted virus that causes cervical cancer, are being reported in the District of Columbia and 20 states, including Virginia. The reactions range from loss of consciousness to seizures.
MERCK'S GARDASIL VACCINE NOT PROVEN SAFE
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. 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.
Animal and human studies have shown that aluminum can cause nerve cell death  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. 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.