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Human Papilloma Virus or HPV is an incurable
sexually transmitted disease. And it's the cause of most cases of cervical
caner in women. Merck and another huge pharmaceutical company have developed
a vaccine for HPV. This latest development has created a controversy:
the new vaccine will encourage sexual activity among our youth. Others
say they need to be protected. But Merck has crossed the line. They
have plans to lobby states to require the vaccine for all twelve-year-old
children before they can enter school. It won't matter if you're teaching
your children abstinence until marriage. If Merck gets its way, they'll
force you to pay for the vaccine and impose it on your children. All
the while, Merck will be making tens of millions of dollars selling
the vaccine.
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Overview
WHITEHOUSE STATION, New Jersey, February 21, 2007 (LifeSiteNews.com)
- The Growing opposition among family and medical organizations, along
with Among the groups opposed to the campaign was the American Academy
of "Merck's early push was not the way to go," said Larry
Pickering, The vaccine's benefits were sharply questioned by the National
Vaccine In a statement to the press June 27, 2006, the NVIC criticized
the Food "Merck and the FDA have not been completely honest with the
people about In particular, the use of aluminum in the vaccine and placebo
used in "Merck and the FDA do not reveal in public documents exactly
how many 9 to "Clinical trial investigators dismissed most of the 102 Gardasil
and "There is too little long term safety and efficacy data,
especially in More than 20 states are considering legislation that would make
the Apart from the revelation of serious health concerns and inadequate
Read NVIC statement on dangers of Gardasil: (c) Copyright: LifeSiteNews.com is a production of Interim Publishing.
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What's all this noise about the the test?
27 June 2006
MERCK'S GARDASIL VACCINE NOT PROVEN SAFE (Excerpt)
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 [June 27, 2006]
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Latest News:Canada Published: Thursday, March 22, 2007 A lobbyist with past ties to Prime Minister Stephen Harper was retained last month by the drug company that stands to benefit from a newly announced $300 million in federal funding for a vaccination program to prevent cervical cancer. Ken Boessenkool, who served as Mr. Harper's senior policy adviser until 2004, registered to lobby the federal government on immunization policy on behalf of Merck Frosst Canada. On Monday, Finance Minister Jim Flaherty announced in his budget statement that the government would make a $300-million fund available to provinces and territories to pay for the costs of vaccinating girls and young women against human papillomavirus (HPV), the leading cause of cervical cancer. The Harper government's decision to fund the HPV vaccination surprised some observers, particularly with the negative response from some conservative groups against Merck's efforts to win support for the vaccine in the U.S. Faced with a strong backlash, the company recently suspended its U.S. lobbying efforts. As the manufacturer of Gardasil, the only approved vaccine for HPV in Canada, Merck Frosst appears well-positioned to benefit from the program. Provinces or territories that want to take advantage of the funding for the HPV vaccination programs must come to Merck to buy the vaccine. The vaccination costs about $300 for a course of three Gardasil injections. There are no generic versions available. In his filings with the Registrar of Lobbyists, Mr. Boessenkool listed his potential points of contact as the Prime Minister's Office, Health Canada, Industry Canada, the Privy Council Office and MPs. He listed his subject matter as "Monitoring health and immunization policies especially effecting (sic) National Immunization Strategy." Mr. Boessenkool works in the Calgary office of the lobbying firm Hill & Knowlton. Merck also retained Hill & Knowlton president Michael Coates to lobby on immunization. Merck spokesman Vincent Lamoureux said the firm had a specific mandate to lobby the federal government on Gardasil. "We had a lobbying firm to help us understand the policy process of government," Mr. Lamoureux said. Merck has worked with Hill & Knowlton for many years, during Conservative and Liberal governments, he said. Hill & Knowlton also lobbies the Ontario government on HPV vaccination. Mr. Lamoureux said the company was pleased by the federal government announcement and called it "excellent news for Canadian women." Although cervical cancer is the second-most common type of the disease in women aged 20 to 44, it remains comparatively rare. There were only 1,350 new cases last year and 390 deaths. Still, the National Advisory Committee on Immunization last month recommended vaccination with Gardasil for girls as young as nine and women up to age 26. Neither Mr. Boessenkool nor Mr. Coates returned calls for comment. Mr. Coates, who worked as a volunteer adviser for the Conservatives during the last two election campaigns and helped Mr. Harper prepare for the televised leaders' debate, wrote in an e-mail that it was Hill & Knowlton policy not to comment on clients' issues without their permission. © The Ottawa Citizen 2007 |
Conflict of Interest
You've probably heard of Gardasil. It's a vaccine, developed by the drug conglomerate,
Merck and Co., which is effective against some of the many strains of Human
Papilloma Virus (HPV). HPV is a sexually transmitted disease and considered
to be the seed of cervical cancer, causing a vast majority of reported cases.
Gardasil has been recommended for girls and women ages 9 to 26.
It can legitimately be argued that this medical breakthrough is a positive
advance for women's health. However, we've previously witnessed several medical
advances that crossed ethical boundaries, and the makers of Gardasil are no
exception.
Merck is helping to bankroll efforts to pass state laws mandating the use
of Gardasil for girls as young as 11-years-old. Their efforts are working.
Currently, at least 18 states are debating whether or not to mandate Gardasil
for schoolgirls.
Merck is admittedly funneling money for this lobbying effort through an advocacy
group called, Women in Government. Its membership consists of female state
legislators around the nation. Members of Women in Government have introduced
many of the state bills mandating Gardasil around the nation. Merck won't
say how much money they're spending on the lobbying effort, but it's been
reported they've doubled their lobbying budget to between $150,000 and $250,000
in Texas alone, where mandating the drug is expected to be a harder sell.
This development is a conflict of interest for the drug company. Let's consider
the financial windfall Merck would enjoy if states mandate the use of Gardasil.
Each regimen of the drug costs $360. It's given in three injections over a
six-month period. Steve Brozak, a drug-industry analyst from WBB Securities,
projects Gardasil will reach at least one billion dollars in sales every year.
He believes billions more will be made for the company if states require the
vaccine.
Even though most states propose opt-out provisions for parents who have moral
objections, the requirement intrudes on families' privacy and it begins to
chip away at parents' authority to make moral and medical decisions for their
children. Further, it sends a conflicting message to children whose parents
advocate abstinence until marriage. The vaccine should be available to parents
and women who want it, but it shouldn't be pushed or forced on those who don't.
Texas Governor, Rick Perry, says "I look at this no different than vaccinating
our children for polio." I respectfully disagree. It sends the wrong
message to millions of unsuspecting and vulnerable young girls that the risks
of premarital sex are minimized with this vaccine. It will likely provide
a false sense of security among many girls, resulting in more teenage sex,
other STDs, pregnancy and abortion. It has taken years of effort to reduce
the pregnancy and abortion rate of teenage girls. We don't want to see government
programs enacted which reverse this positive trend.
Sadly, missing in the discussion on Gardasil is this key point: HPV is a preventable
disease if people don't engage in risky sexual behavior. And it appears nearly
everyone discussing the issue seems to have abdicated the concept of abstinence
until marriage - the best and most simple answer.
Sincerely,
Bradley Mattes
Executive Director
Life Issues Institute
www.lifeissues.org
1/31/07
Life Issues Institute is dedicated to changing hearts and minds of millions
of people through education. Organizations and individuals around the world
depend upon Life Issues Institute to provide the latest information and effective
tools to protect innocent human life from womb to tomb. Please visit our home
page for more pro-life news!
* The American College of Pediatricians is opposed to "any legislation which would require HPV vaccination for school attendance. This would amount to a precedent-setting action that trespasses on the right of parents to make medical decisions for their children as well as on the rights of the children to attend school. Most 9-12 year old children are not sexually active; many have not entered puberty. Forcing a parent to forsake his/her better judgment and discuss this information with the child would be inappropriate and unnecessarily intrusive."
* The National Vaccine Information Center (NVIC), a leading vaccine
safety and informed consent advocacy organization, is urging state legislatures
to investigate the safety and cost of mandating Merck's HPV vaccine for all
pre-adolescent girls before introducing legislation amending state vaccine
laws. NVIC reports that testing of the drug resulted in numerous health problems,
including loss of consciousness, seizures, arthritis joint pain and Guillain-Barre
Syndrome.
Materials currently on hand - for your information below.
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HPV Vaccine: Vaccine Center Issues Second Warning (updated 3.07) The National Vaccine Information Center (new update 21Feb) warned state officials to investigate the safety of a cancer vaccine as Texas became the first state to make the HPV vaccine mandatory for school-age girls (this webpage is being updated regularly)... http://www.medinstitute.org/content.php?name=HPVVaccineStatement [The articles found here have been rearranged in chronological order for a better flow of information] 27 June 2006 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.[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 [June 27, 2006] The info below was forwarded by a Texas legislator who is a survivor of cervical cancer and who opposes Gov. Perry's mandate for her 15 year old daughter as well as for her state. This is "another misguided move promoted by pharmaceutical companies, who will profit enormously". HPV Vaccine Mandate for 6th Grade Girls What Do We Really Know About the HPV Vaccine? QUESTIONABLE NECESSITY AND EFFECTIVENESS The American Cancer Society says that even though infection with the sexually transmitted virus HPV is an important risk factor for cervical cancer, most women with HPV infection do not get cervical cancer. Doctors believe other factors must come into play for this cancer to develop. Some of these factors are smoking, HIV infection, Chlamydia infection, diet, long-term use of birth control pills, multiple pregnancies, low income, mothers who took hormonal drug DES, and family history. [1] These are not typical risk factors affecting junior high girls. According to the National Institutes of Health National Cancer institute, in more than 90% of the cases, HPV infections are harmless and go away without treatment. [2] Also, according to the CDC, most cervical cancer can be prevented and cervical cancer is very rare in women who get regular PAP tests.[3] Cervical Cancer is not a major killer in the state of Texas thanks to PAP screenings: in 2000, there were 371 deaths from cervical cancer, in 2001 there were 352 and in 2002 there were 329. [4] The CDC says there are more than 100 strains or types of HPV and over 30 strains are sexually transmitted. [5] Yet the vaccine under consideration for mandate covers only 4 strains. [6] Merck says that about 30% of cervical cancers can't be prevented by the vaccine, so women will still need regular cervical cancer screenings. [7]. The only current vaccine manufacturer for the HPV vaccine, Merck, admits on their package insert that the duration of immunity from the vaccine is unknown. [8] In clinical trials, the vaccine's effectiveness was followed for 4 years.[9] Yet we do know from the CDC that the incubation period for the HPV virus is about 20 years [10] and the median age of women diagnosed with cervical cancer is 48 [11]. Therefore, no claims to proof of cervical cancer prevention by vaccinating preteen girls should be made. QUESTIONABLE SAFETY The HPV vaccine Gardasil was approved by the FDA on June 8, 2006 after 6 months of review.[12] It has been on the market for less than 1 year. The chairman of the American Academy of Pediatrics committee on infectious diseases was quoted in the Washington Post in response to a proposed mandate in Washington D.C. saying that he thought it was premature to recommend making the vaccine mandatory. "I think it's too early," said Joseph A. Bocchini,…"This is a new vaccine. It would be wise to wait until we have additional information about the safety of the vaccine." [13] Dr. Martin Meyers, director of the National Network for Immunization Information, was quoted in the Baltimore Sun in response to a proposed bill in Maryland to mandate HPV vaccines for 6th grade girls, "A lot of us are worried it's a little early to be pushing a mandated HPV vaccine." He also said "It's not the vaccine community pushing for this." The article spotlighted HPV vaccine manufacturer Merck's aggressive role in pushing for a mandate where across the U..S., HPV vaccine mandates could mean $4 billion dollars in sales for Merck [14] who is currently plagued by lawsuits for withholding critical safety information to doctors and patients about their popular painkiller drug Vioxx.[15] The FDA's Vaccine Adverse Events Reporting System has already received 82 reports of serious adverse events following HPV vaccination with Gardasil since its approval last June. [16] More questions remain. Disclaimers printed on the manufacturer's package insert state that the vaccine has not been tested for it's own ability to cause cancer [17] and the effect on a woman's reproductive capacity is unknown. [18] Additionally, the vaccine is genetically engineered yet the manufacturer admits it has not tested the vaccine for genotoxicity[17] (testing to see if the vaccine is toxic to our own human DNA). Each dose of the vaccine contains 225 mcg of aluminum [6] which means girls receiving all 3 HPV doses will be directly injected with 675 mcg of aluminum. QUESTIONABLE COST The retail cost of the vaccine is $120 per dose, or $360 for the full series of 3 shots. [7] According to the bill's author Sen. Leticia Van de Putte, there are 162,000 6th grade girls[19] which translates to forcing Texas families paying over $58 million dollars not including the doctor visits for a vaccine not proven to prevent cervical cancer. This is a high price to force families to pay especially for families skeptical of the necessity, efficacy, or safety of the vaccine. Merck is absolved from liability for the injuries and deaths caused by the HPV vaccine through the National Childhood Vaccine Injury Act of 1986 [20] leaving families to deal with the emotional and monetary costs of the harm caused by the vaccine to their daughters on their own. The vaccine is available to anyone who wants it, so it does not need to be mandated. Federal health programs such as Vaccines for Children cover the HPV vaccine to children and teens under 19 years of age, who are either uninsured, Medicaid-eligible, American Indian, or Alaska Native. The VFC Program also allows children and teens to get VFC vaccines through Federally Qualified Health Centers or Rural Health Centers, if their private health insurance does not cover the vaccine [7], so insurance mandates which raise the cost of insurance for everyone who does not want or need the vaccine are not necessary. [1] The American Cancer Society, What Causes Cancer of the Cervix. Link: What Causes Cancer of the Cervix [2] The National Institutes for Health, National Cancer Institute . [3] The Centers for Disease Control and Prevention, Cervical Cancer Screening and Prevention. Most cervical cancer can be prevented [4] The Centers for Disease Control and Prevention United States Cancer Statistics. http://apps.nccd.cdc.gov/uscs/ [5] Centers for Disease Control and Prevention, Sexually Transmitted Diseases, Genital HPV Infection - CDC Fact Sheet. http://www.cdc.gov/STD/HPV/STDFact-HPV.htm [6] Gardasil package Insert. 2006. Page 1. http://www.fda.gov/cber/label/hpvmer060806LB.pdf [7] Centers for Disease Control and Prevention, HPV Vaccine Questions and Answers. http://www.cdc.gov/STD/HPV/STDFact-HPV-vaccine.htm [8] Gardasil package Insert. 2006. Page 5, paragraph 6. http://www.fda.gov/cber/label/hpvmer060806LB.pdf [9] Gardasil package Insert. 2006. Page 2, paragraph 2. http://www.fda.gov/cber/label/hpvmer060806LB.pdf [10] Centers for Disease Control and Prevention, National Immunization Program, Advisory Committee on Immunization Practices, Minutes of the October 26-27, 2005 ACIP meeting, p. 57. http://www.cdc.gov/nip/acip/minutes/acip-min-oct05.pdf [11] National Institutes of Health, National Cancer Institute, Cancer Stat Fact Sheets http://seer.cancer.gov/statfacts/html/cervix.html [12] FDA News, Press Release. http://www.fda.gov/bbs/topics/NEWS/2006/NEW01385.html [13] The Washington Post, "D.C. Bill Would Mandate Vaccine" by Nikita Stewart and Rob Stein. January 10, 2007, p. A01. Link: Washington Post article - D.C. Bill Would Mandate Vaccine [14] The Baltimore Sun, "Drug Firm Pushes Vaccine Mandate, Merck Lobbies Md. On HPV Preventive. by Laura Smitherman, January 29, 2007 . [15] The Star-Ledger, "Attorneys Lay Out Cases to Open Double Vioxx Trial", by Susan Todd, January 23, 2007 .
[17] Gardasil package Insert. 2006, Page 8, paragraph 17. http://www.fda.gov/cber/label/hpvmer060806LB.pdf [18] Gardasil package Insert. 2006, Page 9, paragraph 1. http://www.fda.gov/cber/label/hpvmer060806LB.pdf [19] Houston Chronicle, Vaccine Proposal Likely to Stir Debate, by Todd Ackerman. Jan. 10, 2007. http://www.chron.com/disp/story.mpl/front/4459579.html. [20] U.S. Department of Health and Human Services Health Resources and Services Administration National Vaccine Injury Compensation Program. http://www.hrsa.gov/vaccinecompensation/ [prepared by Dawn Richardson, http://www.vaccineinfo.net/]
~October 2006 http://www.vaccineinfo.net/immunization/vaccine/hpv/doc_against_HPV.shtml 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. However, the time course from CIN III to invasive cancer averages between 8.1 to 12.6 years.2 Claiming this vaccine prevents cervical cancer, with the longest median study subject being 4 years, is inappropriate. The vaccine only "protects" against 4 high risk HPV subtypes. We are currently screening for 15 "high risk" HPV subtypes. This may lead to an increase in infection with other and possibly more aggressive subtypes. According to ACOG, "The vast majority of women clear or suppress HPV 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."3 Seventy percent of women clear the virus spontaneously after 18 months and 90 % clear the virus after 2 years.4 Vaccinating children against HPV with a vaccine that is of unknown duration of efficacy may 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, including the cervical cancer which the vaccine is supposedly preventing. This would require an unknown number of boosters and is a setup for complacency in the older population that is a recipe for disaster. The likelihood for regression to a normal pap from CIN II with expectant management is 40%.5 This beats Gardasil's reduction of CIN II-III of only 39% in the "general population impact group" which is where most people would currently fall.6 This includes "all subjects who received at least one vaccination (regardless of baseline HPV status at Day 1."7 Since ACOG does not currently recommend serologic testing for HPV before vaccination this will be the endpoint from here out. In this case, "first do no harm" rules. 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? Vaccinating children for this or any other sexually transmitted infection is not without risk. There are over 30,000 immunization reactions reported to the Vaccine Adverse Events Reporting System (VAERS) annually 8, and it has been estimated that only 10% or less of vaccine reactions are reported.9 In light of these facts the integrity of the post marketing surveillance of vaccines is questionable. Currently no vaccine has ever been examined for possible carcinogenic, mutagenic, or teratogenic effects, and yet the pharmaceutical industry stands ready to add Gardasil to the list of vaccines mandated for school admission. Currently, precancerous lesions are readily identifiable and treatable in the developed world. Cervical cancer causes approximately one percent of all cancer deaths in America. The 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. The Committee Opinion states that there continues to be a significant population of women not receiving adequate screening. If you estimate the cost of the series at $360.00 (the most expensive vaccine on the market) administered to all adolescent girls and use that money to expand and enhance screening, I believe the results might be quite impressive. To invest that amount of healthcare dollars in an immunization with no long term efficacy or safety data is unwise. 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 premature.
Drug Conglomerate funds campaign to impose Mandatory
HPV Vaccine on Young Girls A nation-wide campaign to introduce mandatory vaccination against the sexually-transmitted Human Papilloma Virus for girls as young as nine is being funded by the drug company that produced the vaccine. Gardasil, the highly-publicized vaccine recently developed to prevent HPV infections in sexually active young women, has been aggressively marketed in the US as a protection against the disease responsible for the vast majority of cervical cancer. HPV is contracted through sexual activity, with sexually promiscuous behavior greatly increasing the likelihood of infection. The massive drug company Merck and Co. developed the vaccine. Merck is helping to fund efforts to establish state laws mandating immunization of 11 and 12 year olds, according to a report released by the Life Issues Institute Jan.31. The company has admitted to funneling money through the advocacy group Women in Government, with a membership of female state legislators. Members of the group have backed many of the state measures to introduce mandatory immunization with Gardasil. Merck has refused to say how much money is being spent on the lobbying efforts, but reports say their budget in Texas alone has doubled to between $150,000 to $250,000. The US Food and Drug Administration approved Gardasil in July 2006 for sale and marketing to girls as young as nine. Later that month a CDC committee voted unanimously to recommend that girls ages 11 and 12 receive the vaccine. Legislation has been introduced in five states that would make vaccination for HPV mandatory for young girls, including Colorado, Connecticut, Kansas, Michigan, and Wisconsin. A similar bill in Maryland is to be withdrawn, but will likely be reintroduced during the next legislative session, according to a report by the Kaiser Network. Most of the bills would require girls to receive the immunization by age 11--some contain parental opt-out clauses that would allow parents to refuse the vaccine for their daughter by signing a document indicating they were informed on the issue. If the state measures are ratified, the financial boon to Merck would be significant. As it stands the company stands to reach at least $1 billion in sales per year, according to estimates by drug-industry analyst Steve Brozak with WBB Securites. Forcing the vaccine on young girls is an infringement on the rights of their parents, opponents say, and ignores the fact that HPV is a highly preventable disease largely caused by risky sexual behavior. "Even though most states propose opt-out provisions for parents who have moral objections, the requirement intrudes on families' privacy and it begins to chip away at parents' authority to make moral and medical decisions for their children," said Bradley Mattes, executive director of the Life Issues Institute. "Further, it sends a conflicting message to children whose parents advocate abstinence until marriage. Mandating immunization sends the message to young girls that they are expected to engage in sexual activity, Mattes said. "It appears nearly everyone discussing the issue seems to have abdicated the concept of abstinence until marriage - the best and most simple answer." As well, Mattes said the vaccine would undo years of effort to reduce the pregnancy and abortion rate of teenage girls by providing a "false sense of security among many girls, resulting in more teenage sex, other STDs, pregnancy and abortion." See Life Issues Institute report: See report from the Kaiser Network: 3 February 2007 HPV Vaccine Mandates Risky And Expensive http://www.medicalnewstoday.com/medicalnews.php?newsid=62176 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. "GARDASIL safety appears to have been studied in fewer than 2,000 girls aged 9 to 15 years pre-licensure clinical trials and it is unclear how long they were followed up. VAERS is now receiving reports of loss of consciousness, seizures, arthritis and other neurological problems in young girls who have received the shot," said NVIC President Barbara Loe Fisher. "At the same time, parents who take their daughters to private pediatricians are going to be shocked to find that they will be paying two to three times the widely publicized $360 cost for the three-dose series. The cost is going to break the pocketbooks of parents and break the banks of both insurance companies and taxpayers, when the reality is that almost all cases of HPV- associated cervical cancer can be prevented with annual pap screening of girls who are sexually active." Between July 2006 and January 2007, there have been 82 reports of adverse events filed with VAERS following receipt of GARDASIL by girls and boys ranging in age from 11 to 27 years. Reaction reports have come from 21 states, including Virginia and the District of Columbia. All but three of the reports were for adverse events which occurred within one week of vaccination and more than 60 percent occurred within 24 hours of vaccination. "The most frequent serious health events after GARDASIL shots are neurological symptoms," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. "These young girls are experiencing severe headaches, dizziness, temporary loss of vision, slurred speech, fainting, involuntary contraction of limbs (seizures), muscle weakness, tingling and numbness in the hands and feet and joint pain. Some of the girls have lost consciousness during what appears to be seizures." Debold added "The manufacturer product insert should include mention of syncopal episodes, seizures and Guillain-Barre Syndrome so doctors and parents are aware these vaccine adverse responses have been associated with the vaccine." VAERS reports also indicate the doctors are administering GARDASIL to girls and women at the same with Tdap, DT, meningococcal (Menactra), hepatitis A, and other vaccines, even though the Merck product insert states that, with the exception of hepatitis B vaccine, "Co-administration of GARDASIL with other vaccines has not been studied." There is no publicly available information about how many of the 9 to 15 year old girls in Merck's pre- licensure clinical trials received GARDASIL simultaneously with hepatitis B vaccine. Although approximately half of all families in the U.S. select a pediatrician in private practice to provide their children routine care, including vaccinations, children can receive government subsidized reduced cost or free vaccinations in public health clinics through the Vaccines for Children program if they cannot afford to pay for vaccinations administered by private pediatricians. NVIC's survey of four private pediatric practices in the Virginia suburbs of Washington, D.C. found that parents could be charged anywhere from $525 to $930 for three GARDASIL shots depending upon whether the child was a first-time or current patient. Costs for the vaccine plus an administration fee ranged from $140 to $275 per shot with an additional office visit charge that fluctuated between $35 and $185 depending upon whether a nurse or doctor saw the child. HPV is the most common sexually transmitted infection in the U.S. and most persons naturally clear the infection from the body without symptoms. However, many years of chronic HPV infection is associated with a higher risk of pre- cancerous changes in the cervix that can lead to cancer unless diagnosed and treated promptly. High risk factors for chronic HPV infection include smoking, long-term use of oral contraceptives and co-infection with HIV, herpes and chlamydia. There has been a more than 70 percent drop in cervical cancer deaths in American women since the 1950's due to routine pap smears and nearly all cervical cancers can be prevented with regular pap smear screening and treatment. In its product manufacturer insert, Merck states that "Vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care." Merck also states that "The duration of immunity following a complete schedule of immunization with GARDASIL has not been established." For more information about HPV infection and GARDASIL safety, including NVIC's five-page report on GARDASIL adverse event reports to VAERS as well as a direct link to VAERS reports, go to NVIC's website at http://www.nvic.org. National Vaccine Information Center 5 February 2007 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. "Young girls are experiencing severe headaches, dizziness, temporary loss of vision and some girls have lost consciousness during what appear to be seizures," said Vicky Debold, health policy analyst for the National Vaccine Information Center, a nonprofit watchdog organization that was created in the early 1980s to prevent vaccine injuries. Following federal approval of the vaccine in July 2006, a storm of legislation was introduced across the nation that would make the vaccine mandatory in schools. The District and Virginia are part of a group of at least 17 states considering such legislation. A measure had been introduced in Maryland, but it was shelved last week over concerns about the mandatory language in the bill. Yesterday, Texas Gov. Rick Perry signed an order making Texas the first state to require the vaccine. Girls ages 11 and 12 would receive the human papillomavirus (HPV) vaccine before entering the sixth grade starting in September 2008. The American Cancer Society estimates there were 9,710 new cases of cervical cancer in the United States in 2006. The District's cancer control center estimates a total of cervical cancer cases in the city last year, and the American Cancer Society estimates that last year Maryland and Virginia each had 210 cases of cervical center. Merck began marketing Gardasil last year after the Food and Drug Administration (FDA) approved it for females ages 9 to 26. The vaccine is the first of its kind to build immunity against four strains of HPV: HPV types 16 and 18 lead to 70 percent of cervical cancer cases in the United States, and 6 and 11 which cause 90% of genital warts. According to an independent physician, this vaccine has been studied in detail on over 24,000 women and serious side effects were no different from the placebo in essentially all categories, including mortality. Since moderate to severe dysplasia is known to precede
cervical cancer if untreated, it should dramatically reduce the rates
of cervical cancer RELATED TO HPV 16 and 18. Merck studied a group of women for 4 1/2 years and the antibody levels are stable. Merck plans to continue to study these groups to see any signs which would indicated the need for a booster and let us know. This protocol is just like with any other vaccine. If you have an efficacious vaccine, there is no need to wait 10 or 20 years to learn of the need for a booster. We have and continue to challenge Merck on these issues so we do not just take their word for it. Its side effects were reported to the Vaccine Adverse Event Reporting System, a federal reporting system for consumers to notify federal regulators of bad reactions to medications. The adverse events began being reported in July 2006, when an advisory panel to the Centers for Disease Control and Prevention recommended girls ages 11 and 12 receive the series of shots. The types of side effects reported are not cause for alarm, according to the American Cancer Society. "We have not been informed of an instance that would call into question the overall safety of the vaccine," said Debbie Saslow, director of breast and cervical cancer control at the American Cancer Society, adding that about 70 similar events had been known in October 2006. Likewise, the CDC will not alter its approval of the vaccine despite the number of adverse events revealed through the reporting system. "A report to the Vaccine Adverse Event Reporting System does not necessarily mean the adverse event was serious or that it was caused by the vaccine," said CDC spokesman Curtis Allen. "This vaccine has been tested around the world and has been found to be safe and effective." Merck is heavily promoting the vaccine through its salespeople imploring doctors to provide it and running TV ads urging young women to get vaccinated so there will be "One Less" cancer patient. But physicians disagree with public health officials over whether Gardasil is the panacea for cancer. Clayton Young, an obstetrician/gynecologist in Texas, objects to Merck's claim that Gardasil will prevent cervical cancer. "There is no proof Gardasil will stop cervical cancer," he said. "They haven't been studying it long enough to make that claim." Merck spokesman Chris Loder said the vaccine is effective for five years and the Whitehouse Station, N.J., drug maker is not sure how long afterward the vaccine will work. Critics point out that an additional booster shot may be necessary. Advocates for a mandatory vaccine say that although the vaccine does not prevent all causes of cervical cancer, Gardasil is an effective vaccine against the most prevalent cause and therefore is a correct public health measure. Gardasil is delivered in three separate injections that cost $120 to $150 per injection. Blue Cross Blue Shield, an omnipresent health insurer in the Mid-Atlantic region, covers the vaccine for girls in the federally recommended age groups. Merck revenue from Gardasil reached $155 million for
the fourth quarter of 2006 and $255 million for the entire year. [3Feb07,
The Washington Times, G. Lopes,
The Medical Institute's Statement on HPV Vaccine An HPV (human papillomavirus) vaccine[1] received FDA approval in June 2006. This vaccine is intended to provide immunity against four common HPV types - 16, 18, 6, & 11. Scientific evidence on immunization with the quadrivalent vaccine suggests that it substantially reduces the risk of pre-cancer and cancer of the cervix caused by HPV types 16 & 18[2,3,4] (responsible for ~70% of all cervical cancers in the US)[5], substantially reduces the risk of genital warts caused by HPV types 6 & 11[6] (responsible for ~90% of all genital warts in the US)[7], and is cost effective when administered to adolescent females[8]. However, there is no evidence to suggest that the vaccine... --reduces the risk for cervical cancers caused by other HPV types (responsible for ~30% of all cervical cancers in the US) --reduces the risk of other sexually transmitted infections (STIs) --offers any protection against the other consequences of nonmarital sexual activity such as pregnancy and emotional damage. Furthermore, Therefore, we promote abstinence for unmarried persons as a primary method to prevent pregnancy,[9,10] STIs including HIV,[11] and the emotional consequences of sexual activity[12]; we promote monogamy as a primary method to prevent STIs including HIV[13] --encourage further research into the duration of immunity
and the optimal timing of immunization Finally, we encourage physicians to counsel all their patients regarding sexual health. References: February 5, 2007 Now parents are being told they must get their young daughters vaccinated against HPV as if to say to the child, "We do not expect nor believe that you will stay abstinent until marriage." The decision to get young girls vaccinated for HPV is
not an easy decision to make. In less than a year since approval,
82 cases of serious adverse events following HPV vaccinations of Gardasil
have been reported (http://www.medalerts.org/vaersdb/findfield.php?PAGENO=1&PERPAGE=10&VAX=HPV4).
These incidents should have been discussed thoroughly in open forum
in the Legislature before any mandate was even considered. The HPV vaccine covers 4 out of types of HPV (Types 6, 11,16,18) which account for 70% of cervical cancers and 90% of genital warts. That still leaves 30% of cervical cancers and 10% of genital warts which are not covered by the HPV vaccine. Also, it will be important for the public to be continually reminded that there are many more sexually transmitted diseases than just HPV (e.g., chlamydia, herpes, hepatitis, trichomoniasis, gonorrhea, syphilis, HIV/AIDS, etc.) A definite drawback to Gardasil is that girls must get three full doses of the vaccine for it to be effective. How many families are going to understand the urgency of making sure their girls get three full doses over a six months' period of time? The seriousness of HPV has been one of the driving forces behind the plea for teens to remain abstinent until marriage. Condoms do not offer adequate protection against HPV since the virus is often carried on the parts of the body which are not covered by the condom. It is important NOT to downplay the seriousness of HPV. Close to 90% of women who are infected with HPV will clear it; but according to the American Cancer Society webpage (Link: Cancer.org - How many women get cancer of the cervix=), "The American Cancer Society predicts that there will be about 11,150 new cases of invasive cervical cancer in the United States in 2007. About 3,670 women will die from this disease that same year." In other words, only a small percentage of 80% of women will develop cervical cancer; but because 80% represents a huge number of women, the small percentage of 80% adds up to a very sizeable population -- 11,150 new cases with 3,670 yearly who will die of HPV. Women in Government [is] a powerful group which is pushing Merck's agenda http://www.womeningovernment.org/prevention/documents/LargeCampaignActivityMap2-1-2007.pdf). Gov. Perry's executive order gives the public another reason to doubt politicians... Gov. Perry and his wife may have been very well meaning in trying to protect girls from this dangerous disease; but an executive order was the wrong way to gain public acceptance of the HPV vaccination. Middle-income taxpayers will be hit twice: once to pay higher private insurance premiums and second, to pay for higher taxes to cover the cost of free immunizations for girls on Medicaid and other state/federal programs. A better solution would have been for the Governor to have thrown the power and influence of his office behind abstinence-until-marriage programs and to have enlisted all state agencies, public schools, the film industry, and the media to surround our teens with the unequivocal abstinence message. If after studying all the medical information about
the HPV vaccination, the parents want their daughters to have the
vaccination, then that should be the parents' decision and not one
made by a politician.
7 February 2007 Andy Schlafly, General Counsel for the Association
of American Physicians & Surgeons, successfully debated against
the proposed mandate for the HPV vaccine. View MSNBC's live coverage
of the debate. For every dollar spent on the vaccine itself, there
will be another $1-2 spent by taxpayers and insurance companies administering
the vaccine. That's billions of dollars, and much of it could go to
abortion providers and referral services as they administer this vaccine
under the proposed mandates.
20 February 2007 Merck gives up push for girls to get shots: The Opposition
to STD vaccine called 'distracting' February 20, 2007 This is very good news but the problem is not over. And don't forget to watch out for "Women in Government" who have been lobbying your state for Merck. If you look on the group's website, you'll see the director for your state. Keep an eye on these women (Laura Hall in AL) and the campaign donations they receive. [B.P., 21Feb07]
for immediate release
VACCINE SAFETY GROUP RELEASES GARDASIL REACTION REPORT Washington, D.C. - The National Vaccine Information Center (NVIC) today released a new analysis of the federal Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck's GARDASIL) during the last six months of 2006. Out of the 385 individual GARDASIL adverse event reports made to VAERS, two-thirds required additional medical care and about one-third of all reports were for children 16-years-old and under, with nearly 25 percent of those children having received simultaneously one or more of the 18 vaccines that Merck did not study in combination with GARDASIL. NVIC is calling on the FDA and CDC to warn parents and doctors that GARDASIL should not be combined with other vaccines and that young girls should be monitored for at least 24 hours for syncopal (collapse/fainting) episodes that can be accompanied by seizure activity, as well as symptoms of tingling, numbness and loss of sensation in the fingers and limbs, all of which should be reported to VAERS immediately. "Because Merck only studied GARDASIL in fewer than 1200 girls under age 16 in pre-licensure trials, it is critical that doctors and parents be made aware of the nature of the initial adverse event reports coming into VAERS and that they report serious health problems after vaccination when they occur," said NVIC President Barbara Loe Fisher. "There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a GARDASIL vaccination compared to those getting a Tdap (tetanus-diphtheria-acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre Syndrome. And doctors who give GARDASIL in combination with other vaccines are basically conducting an experiment on their young patients because Merck has not published any safety data for simultaneous vaccination with any vaccine except hepatitis B vaccine." According to NVIC's report, a majority of GARDASIL adverse
event reports to VAERS involved those who suffered fever, nausea,
headache or pain; 14 percent were for syncopal episodes with or without
neurological signs; and 8 percent experienced tingling, numbness and
loss of sensation, facial paralysis or Guillain-Barre Syndrome. "About 4 reports per day were filed with VAERS in December 2006 for the HPV vaccine," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. "Some of these girls are being injured when they collapse after getting the vaccine and others are complaining of neurological symptoms that should not be ignored. Doctors and nurses should take note of the patient safety issues related to giving this vaccine. Giving GARDASIL simultaneously with any of the 18 vaccines Merck did not study in combination is not an evidence-based guideline and should involve informed consent and a signed patient release. To avoid unnecessary injuries, teenage girls should be vaccinated laying down, not be left unattended and probably should not walk or drive themselves home from the doctor's office after they get vaccinated." NVIC also found that there were several VAERS reports of HPV infection, genital warts and cervical lesions after GARDASIL vaccination. It is unknown if the girls were infected with HPV before being vaccinated or if GARDASIL failed to protect them. One case of HPV infection occurred in a 22-year-old girl who had participated in a Merck GARDASIL trial in 2003 when she had shown "strong conversion to all 4 vaccine types" but "tested positive for high risk HPV" in 2006, according to the VAERS report. In a May 18, 2006 Background Document for the FDA Vaccines and Related Biological Products Advisory Committee (VRPBAC), the FDA staff stated that Merck clinical trial data indicated there may be "the potential for GARDASIL to enhance cervical disease in subjects who had evidence of persistent infection with vaccine-relevant HPV types prior to vaccination." [2] Girls and women now being vaccinated with GARDASIL are not routinely being tested for active HPV infection before vaccination. The FDA staff also questioned whether the "HPV types not contained in the vaccine might offset the overall clinical effectiveness of the vaccine." There are more than 15 types of HPV associated with cervical cancer but GARDASIL only contains HPV types 16 and 18. It is unknown whether non-vaccine HPV types will become more dominant in the future. However, there are indications this could occur because some of the seven strains of pneumococcal contained in Wyeth's PREVNAR vaccine, which was recommended by the CDC for universal use in all babies in 2000, have been replaced by some of the more than 80 other pneumococcal strains not contained in the vaccine. [4] [5] [6] VAERS is a passive surveillance system and depends upon voluntary reporting of serious health problems following vaccination, even though safety provisions in the National Childhood Vaccine Injury Act of 1986 mandated that health care providers report vaccine adverse events. There have been estimates that fewer than 10 percent, even as low as 1 to 4 percent, of adverse events which occur after prescription drug or vaccine use are ever reported to government adverse event reporting systems. [7] [8] [9] [10] "If only 1 to 4 percent of all adverse events associated with GARDASIL vaccination are being reported to VAERS, there could have been up to 38,000 health problems after GARDASIL vaccination in 2006 which were never reported," said Fisher. "How many girls are really having short-term health problems associated with getting this vaccine that could turn into long-term neurological or immune system disorders? And how many will go on to develop fertility problems, cancer or damage to their genes, all of which Merck admits in its product insert that it has not studied at all? We just don't know enough to be mandating GARDASIL for anyone, much less vulnerable 11 to 12 year old girls entering puberty." For a copy of NVIC's Report on VAERS and GARDASIL, references for this statement and information about how to report a vaccine reaction to VAERS, go to www.nvic.org. References: [1] Food and Drug Administration, Center for Biologics
Evaluation Research. Feb. 13, 2007. FDA Public Health Notification:
Information on Rota Teq and Intussusception. http://www.frc.org/get.cfm?i=IF07B01&f=WA07C01 Medical Institute of Sexual Health: Focus on the Family Green Journal:
21 February 2007 Perry's staff discussed vaccine on
day Merck made donation: Spokesman says timing a coincidence.
21 February 2007 Cancer-virus vaccine targets wrong age group. 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. "It is a delicate balancing act," said Debbie Saslow, director of breast and cervical cancer control at the American Cancer Society. "If the vaccine is given at too young an age, it may wear off. Yet if it is given too late, it won't work." Merck & Co. is still studying the longevity of Gardasil, the lone HPV vaccine on the market, which won approval from the Food and Drug Administration in June. But that hadn't impeded its lobbying efforts. Legislators in at least 20 states and cities, including Virginia and the District of Columbia, are considering HPV vaccinations for girls 11 to 13 as a requirement for school attendance. Texas already has done so. "We are doing further tests and follow-up. But right now, we know it is effective for five years," said Dr. Richard Haupt, executive director of medical affairs in Merck's vaccine division. Gardasil, a $360 series of three shots over six months, protects against two HPV strains that cause nearly 70 percent of cervical cancer cases. It also prevents two strains linked to 90 percent of genital warts cases. Merck, which did not respond to repeated requests for
its HPV incubation statistics, unexpectedly suspended its lobbying
campaign yesterday. "It can occur more rapidly, but very commonly, it is a 20-year period before it leads to cancer," said Dr. Bocchini, whose group has endorsed HPV vaccinations on 11- and 12-year-olds but has withheld support for its mandated use. Even when applying a longer 20-year incubation period, requiring Gardasil for sixth-grade girls, as nearly all the legislation does, would not prevent the overwhelming majority of cervical cancer cases in the U.S. American Cancer Society numbers show that from 2000 to 2003, more than 70 percent of cervical cancer patients were older than 40 -- still outside Gardasil's five-year protection window if given to sixth-graders. Merck is working on a booster shot to extend Gardasil's five years of protection. "We are aware of some evidence of immune memory. But if a booster shot is necessary, it would likely be another dose of Gardasil," Dr. Haupt said. None of the HPV vaccine legislation being considered addresses the potential for booster inoculations that could fall outside the enforcement mechanism -- rules that bar students from school unless they have the required shots. Vaccine boosters vary in longevity. A hepatitis B booster is required every 10 years, while others can provide lifelong immunity. Lawmakers pushed HPV legislation to the fast track after
the Advisory Committee on Immunization Practices, run by the Centers
for Disease Control and Prevention, in July endorsed such an inoculation
for girls 11 to 12. Seventy percent of females are sexually active by age 18, according to the CDC. But based on cancer statistics, cervical cancer incubation periods, and the five-year life-span of Gardasil, state lawmakers -- who have billed the inoculations as a cure to cervical cancer -- would have a much greater effect on cervical cancer rates by mandating its use later. Cervical cancer rates are less than one per 100,000 women until age 20 and then begin to pick up in the late 20s and early 30s. Thus, women who likely contracted HPV in their early 20s could be protected by Gardasil taken at 17 or 18. GlaxoSmithKline is developing another HPV vaccine, Cervarix,
which has not been licensed but is expected to be released later this
year. It is effective for 4½ years, according to an April 2006
study in Lancet, a British medical journal. "However, only a few will get an infection that stays and won't go away, and only a portion of those will get a precancerous lesion. At that point, only a few will eventually develop cervical cancer," Dr. Saraiya said. Fewer than one-hundredth of 1 percent of the 108 million U.S. women older than 18 (0.009 percent) get cervical cancer and even fewer die from it. There were an estimated 9,700 new cervical cancer cases and 3,700 fatalities in 2006, according to the American Cancer Society. But the fact that very few U.S. women are affected by cervical cancer, statistically speaking, hasn't stopped the rush by lawmakers to push mandatory HPV vaccines for school girls. Earlier this month, Texas became the first state to enact an HPV vaccine law when Gov. Rick Perry bypassed the Legislature and signed an executive order mandating all girls entering sixth grade be inoculated. Mr. Perry drew fire when it was revealed that his former chief of staff was lobbying for Merck. Lawmakers are trying to reverse the order. In Maryland, HPV legislation was pulled days after a Baltimore Sun report on Merck's lobbying efforts in Annapolis. The bill's sponsor, state Sen. Delores Kelley, Baltimore County Democrat, cited the growing burden on families because of the high costs of mandatory vaccinations. Virginia Delegate Phillip A. Hamilton, Newport News Republican, sponsored the HPV-vaccination legislation that his state's House passed earlier this month and is expected to become law. "What was intriguing to me was that it was a cancer vaccine," he said. Mr. Hamilton, who has received contributions from Merck
in the past, said the pharmaceutical company played no role in his
decision to the sponsor the bill. D.C. officials have just begun hearings on a proposal to require HPV vaccinations before girls turn 13 and to create an HPV reporting program in the city's Department of Health. Merck has waged an extensive lobbying campaign in statehouses, and has helped raise the profile of HPV through a large-scale communications campaign, highlighted by the "Tell Someone" TV ad being shown on channels with high-teen viewership, such as MTV. Wall Street analysts predict that Gardasil, which is projected to generate $2 billion to $4 billion this year without state mandates, will help offset losses Merck endured after it pulled Vioxx off the market in 2004. Vioxx, an FDA-approved anti-inflammatory drug for osteoarthritis
and acute pain that was used by 2 million people, was linked to increased
risk of heart attack and stroke. "Merck's goal is to support
efforts to implement policies that ensure that Gardasil is used to
achieve what it was designed to do: help reduce the burden of cervical
cancer -- the second-leading cancer among women around the world --
and other HPV-related diseases for as many people as possible, and
as quickly as possible," Merck said about its lobbying efforts.
"Because HPV infection is caused by sexual activity, it is not transmitted by casual contact and therefore is not in the same class as other diseases like polio for which mandatory, school-based vaccination is a public-health imperative," Family Research Council President Tony Perkins said in an alert sent to its members to lobby Mr. Perry to rescind his Texas order. Delegate John J. Welch III, Virginia Beach Republican, opposes his state's measure for several reasons. "I think parental rights are paramount. They should trump everything," Mr. Welch said. "When we have a drug that can cure cancer, of course I'm all for it," he said. "But given the fact the drug is so new, I don't think that the commonwealth should mandate it." Once a major killer in the U.S., cervical cancer has been nearly wiped out since the creation of the Pap test, which detects precancerous lesions and early cancer and is credited with a 74 percent drop in cervical cancer deaths since 1955. The CDC says most cervical cancer diagnoses in the U.S. are in women who either have never had a Pap test or have not had a Pap test in the previous five years. Those inoculated with Gardasil still will have to have regular Pap tests for the disease, which is hard to detect because it does not usually cause pain. Cervical cancer does have high mortality rates in low-income regions of U.S. and poor nations where health care coverage is not routine. Cervical cancer is the fifth most common cancer among women worldwide, according to the World Health Organization, and kills about 230,000 women a year, most in developing countries. Because of these figures, public health officials still back use of the vaccine. "The vaccine is not nearly as effective as vaccines
for mumps or measles, but it is an important step forward in public
health," said Dr. John Swartzberg, director of public health
policy at the University of California at Berkeley. "The vaccine
will decrease the two most common strains of HPV that cause cancer,
and we'll be left with strains that have far less potential to cause
cancer. In this case, the benefits outweigh the risks." Dr. Clayton Young, an obstetrician-gynecologist in Texas, is concerned that Gardasil will actually strengthen cancer-causing strains of HPV. "My concern is that we are pushing ourselves into something worse than we already have," Dr. Young said. "Vaccinating for only two strains may lead to an increase in infection with other and possibly more aggressive strains." Gardasil is effective against two of 10 carcinogenic HPV strains. Those two strains dominate the current statistics, estimated to have caused 6,800 new cervical cancer cases in 2006, while the other eight strains combined affected 2,900 women. The probability of additional cancer-causing HPV strains leading to as many cervical cancer cases as today is minute, said Dr. Haupt, executive director of medical affairs in Merck's vaccine division. Despite Merck's doubt, the company is studying the additional cancer-causing HPV types in Scandinavian countries, where national cancer registries allow drug companies to track people with the disease. "It is an important issue to us," Dr. Haupt said. "But we think the two types of HPV that Gardasil work for are unique, and if other types become more common, they will not cause cancer at the same rate and won't over time." Physicians also point to concerns about Gardasil that cast doubt on the vaccine's overall capability to stop cervical cancer from occurring in females. For instance, clinical trials for the vaccine's effectiveness at preventing cervical cancer did not include the age group of girls for whom the vaccine is being recommended. "The number one problem with the vaccine is that it has not been tested adequately on the group that is recommended to get it," said Dr. Joseph DeSoto, a fellow in the American Institute of Chemists and a physician-scientist at the National Institutes of Health. According to Merck's clinical study documents on Gardasil, 20,541 women ages 16 to 26 participated in four studies. The documents show some data is available on 9-year-old girls related to immune responses to the vaccine but not whether it prevents cancer. Because most 9-year-old girls are not sexually active, it is not possible to test the effectiveness of Gardasil against cervical cancer, Mr. Haupt said. Instead, the clinical trials measured antibody responses against HPV as a proxy for cervical cancer. Merck conducted two clinical trials that involved 1,121 girls ages 9 to 15, according to Merck's labeling documents for Gardasil. "The clinical trials tested younger girls, but they only looked at immune response to the vaccine, not whether it prevented cervical cancer," Dr. Young said. "It has not been studied long enough to know that it prevents cervical cancer." [21Feb07, Gregory Lopes and Christopher M. Dolan, Jim McElhatton contributed to this report, The Washington Times ]
Merck Drug Company Drops Campaign for Mandatory HPV
Vaccine: Alarm raised over incomplete disclosure of serious side
effects. Previous: Drug Conglomerate funds campaign to impose
Mandatory HPV Vaccine on Young Girls HPV Condom Study Shows The Failure of Condom Education
Merck had been funneling money through an advocacy group,
Women in Government.
Homosexual men seek 'female cancer' HPV Vaccine. Homosexual men are requesting a controversial "sex disease" vaccine designed to prevent a female cancer. Gardasil protects against the most common of sexually transmitted infections, human papillomavirus (HPV), which can cause cervical cancer. But HPV also causes genital warts and anal and penile cancer, and men argue the vaccine would guard against these. Many private clinics are offering it to men. One in London says it has immunised dozens in the last six weeks. Controversy The government is considering whether all girls, and
possibly boys, aged 11 or 12 should get it routinely in schools, ultimately
to cut cervical cancer rates. Strong demand "We've had a strong demand for it. I had a man
come in for the vaccine this morning. He was 24. Then I have one this
afternoon who is 67 years old. More proof "We should not just be looking at vaccinating people
in their pre-teen years. Other people would benefit as well." Trials in men Merck said its priority was to tackle cervical cancer,
but has not ruled out giving the vaccine to other groups - including
men who have sex with men. About 400 people are diagnosed with anal cancer each
year in the UK. The disease is slightly more common in women than
men.
27 February 2007 CDC Doctor Opposes Law for Vaccine. The chairman of the federal panel that recommended the new cervical-cancer vaccine for pre-teen girls says lawmakers should not make the Gardasil inoculation mandatory, as the District and more than 20 states, including Virginia, are considering. Dr. Jon Abramson, chairman of the Centers for Disease Control and Prevention's advisory committee on immunization practices (ACIP), also said he and panel members told Merck & Co., the drug Gardasil's maker, not to lobby state lawmakers to require the vaccine for school attendance. "I told Merck my personal opinion that it shouldn't be mandated," Dr. Abramson told The Washington Times. "And they heard it from other committee members." Dr. Abramson said he opposes mandating Gardasil, which prevents the cervical-cancer-causing human papillomavirus (HPV), because the sexually transmitted HPV is not a contagious disease like measles and he is not sure states can afford to inoculate all students. "The vaccines out there now are for very communicable diseases. A child in school is not at an increased risk for HPV like he is measles," Dr. Abramson said. In addition, Dr. Abramson said a discussion about making the vaccine mandatory should not be made until states show the money is available to vaccinate every child, adding, "I don't see that yet." Taken in a series of three shots at $120 each, Gardasil is the most expensive vaccine on the market. About 45 percent of children would be eligible for free vaccines from the federal Vaccinations for Children program, while the other 55 percent would depend on the state programs and insurance companies. The ACIP, a 15-member panel charged with developing vaccine schedules and dosages, recommended Gardasil for 11- and 12-year-olds in July, spurring Merck's lobbying efforts and the legislative push to make the HPV vaccine mandatory for sixth-grade girls. Merck suspended its lobbying efforts last week amid criticism from parents, who said it would interfere with control over their children, and from conservative groups that said it would encourage premarital sex. Merck responded yesterday to Dr. Abramson's comments
with a statement it had made previously: Gardasil is nearly 100 percent effective against two strains of HPV that lead to 70 percent of cervical cancer cases in the United States. Nearly 11,000 cervical-cancer cases occur in the U.S. each year, killing more than 3,700, according to the American Cancer Society. But cancer data show that lawmakers looking to force pre-teen girls to take Gardasil, the lone vaccine on the market, are targeting the wrong age group. 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 HPV, The Washington Times reported last week. 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. Dr. Abramson said the panel thinks the vaccine will last for at least 10 years. Even if it provides 10 years of protection, it would still leave girls given the inoculation in the sixth grade vulnerable during their late 20s and early 30s, when most cervical-cancer patients contract HPV. At that point, another round of Gardasil would be necessary. Merck is still studying Gardasil's longevity and the potential for a booster shot. ACIP is the only entity in the federal government to issue immunization recommendations and does not recommend a vaccine be made mandatory; those decisions are left to the states. But the committee's recommendation on the use of a vaccine often plays the lead role in whether states will act to make it part of their mandatory vaccine list, said Barbara Fisher, president of the National Vaccine Information Center, which is opposed to laws making Gardasil mandatory. "They are the signal for states to act," she said. "The committee knows that and I think they see people getting upset about it." Earlier this month, Texas became the first state to enact an HPV vaccine law when Gov. Rick Perry bypassed the state Legislature and signed an executive order mandating all girls entering sixth grade be inoculated. Mr. Perry, who drew fire when it was revealed that his former chief of staff, Mike Toomey, lobbies for Merck, said his order is based on the CDC recommendation. The Virginia General Assembly last week approved legislation
that would require that girls receive the Gardasil before entering
sixth grade starting Oct. 1, 2008. The legislation allows parents
to opt not to have their daughters vaccinated.
HPV VACCINE RESOLUTION [At time of posting (9Mar07), unknown if this resolution has passed.]
Comments by Physicians to AAPLOG AAPLOG does not take a position on HPV vaccination question. (It is not an abortion related issue) If you will allow me a personal comment: The major vector
in HPV Anyway, fyi, here are the unedited comments we received from doctors: Being a prolife gyn with four teenagers of our own I
have definite opinions, xxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxx http://www.nvic.org/Diseases/HPV/pr022107HPV.htm xxxxxxxxxxxxxxxxxxxxx Thanks for your careful handling of a delicate topic...
as an old duffer, I I am currently in Thailand with CMDE and just now decided to check my email as I just finished giving a lecture on HPV and HPV vaccine-ironic. You may know that CMDA has a statement supporting the use of the vaccine but of course supporting abstinence til marriage. I think its very important to offer immunization on a medical and ethical basis since cervical cancer is the number 2 cancer killer for women in the world...I am not commenting on parental rights,drug company lobbying etc but the scientific facts. What a nice opportunity to have another opening to discuss the importance of abstinence with their child.
14 March 2007 Researcher blasts HPV marketing http://www.kpcnews.com/articles/2007/03/14/online_features/hpv_vaccine/hpv01.txt Diane M. Harper, a lead researcher in the development of the humanpapilloma virus vaccine, says giving the drug to 11-year-old girls "is a great big public health experiment." LEBANON, N.H. - A lead researcher who spent 20 years developing the vaccine for humanpapilloma virus says the HPV vaccine is not for younger girls, and that it is "silly" for states to be mandating it for them. Not only that, she says it's not been tested for effectiveness in younger girls, and administering the vaccine to girls as young as 9 may not even protect them at all. And, in the worst-case scenario, instead of serving to reduce the numbers of cervical cancers within 25 years, such a vaccination crusade actually could cause the numbers to go up. "Giving it to 11-year-olds is a great big public health experiment," said Diane M. Harper, who is a scientist, physician, professor and the director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center at Dartmouth Medical School in New Hampshire. "It is silly to mandate vaccination of 11- to 12-year-old girls There also is not enough evidence gathered on side effects to know that safety is not an issue." Internationally recognized as a pioneer in the field, Harper has been studying HPV and a possible vaccine for several of the more than 100 strains of HPV for 20 years - most of her adult life. All of her trials have been with subjects ages 15 to 25. In her own practice, Harper believes the ideal way of administering the new vaccine is to offer it to women ages 18 and up. At the time of their first inoculation, they should be tested for the presence of HPV in their system. If the test comes back negative, then schedule the follow-up series of the three-part shots. But if it comes back positive? "Then we don't know squat, because medically we don't know how to respond to that," Harper said. Harper is an independent researcher whose vaccine work is funded through Dartmouth in part by both Merck & Co. and GlaxoSmithKline, which means she is an employee of the university, not the drug companies. Merck's vaccine, Gardasil, protects against four strains of HPV, two of which cause genital warts, Nos. 6 and 11. The other two, HPV 16 and 18, are cancer-causing viruses. Merck's vaccine was approved last year by the Food and Drug Administration, and recommended in June for females ages 9 to 26 by the Centers for Disease Control's Advisory Committee on Immunization Practices (ACIP). Glaxo has stated publicly that its vaccine, Cervarix, which protects against the two cancer-causing strains, should be on the market by 2008. As the director of an international clinical trial for these vaccines, and as author of lead articles about the vaccines' effectiveness, Harper has been quoted widely as saying this vaccine could have enormous potential to eradicate the great majority of cervical cancers. Not tested on young girls Picking up on this, but before the trials were even completed, major news media and women's advocacy groups began trumpeting the vaccine as an answer to cancer of the cervix. Once it was approved by the FDA and ACIP, Women In Government (WIG), a non-profit organization comprised of female state and federal legislators, began championing Merck's vaccine in their home states, with many of the ladies introducing legislation that would mandate the vaccine for 11- and 12-year-olds. In Indiana, Sen. Connie Lawson, R-Danville, introduced such a bill in this year's General Assembly, but in the face of strong opposition, it was reduced to an education/information-only bill that requires data collection on any Hoosier girls who do get the vaccine. The bill is now awaiting a hearing in the Indiana House. So far at least 26 states are reported to be considering some form of legislation requiring the new vaccine for younger girls. In February, Republican Texas Gov. Rick Perry bypassed his legislature and mandated it for all 11- and 12-year-old girls in his state. Monday, The Associated Press reported that New Mexico's governor, Democratic presidential contender Bill Richardson, is set to sign a bill requiring sixth grade girls in his state to get the vaccine. The idea is to inoculate them before they become sexually active, since HPV can be spread through sexual intercourse. But that idea, no matter how good the intentions behind it, is not the right thinking, Harper said. The zealousness to inoculate all these younger girls may very well backfire at the very time they need protection most, she said. "This vaccine should not be mandated for 11-year-old girls," she reiterated. "It's not been tested in little girls for efficacy. At 11, these girls don't get cervical cancer - they won't know for 25 years if they will get cervical cancer. "Also, the public needs to know that with vaccinated women and women who still get Pap smears (which test for abnormal cells that can lead to cancer), some of them will still get cervical cancer." The reason, she said, is because the vaccine does not protect against all HPV viruses that cause cancer - it's only effective against two that cause about 70 percent of cervical cancers. For months, Harper said, she's been trying to convince major television and print media to listen to her and tell the facts about the usefulness and effectiveness of this vaccine. "But no one will print it," she said. The rest of the story According to Harper, the facts about the HPV vaccine are: o It is not a cancer vaccine or cure. It is a prophylactic - preventative - vaccine for a virus that can cause cancer. "Merck has proven it has zero percent effectiveness for curing cancer," Harper said. "But it is a very, very good vaccine that prevents types of HPV responsible for half of the high-grade cervical lesions that cause about 70 percent of cervical cancers. For the U.S. what that means is the vaccine will prevent about half of high-grade precursors of cancer but half will still occur, so hundreds of thousands of women who are vaccinated with Gardasil and get yearly Pap testing will still get a high-grade dysplasia (cell abnormality)." o It is not 100 percent effective against all HPVs. It is 100 percent effective against two types that cause 70 percent of cervical cancers. o The vaccine only works if the woman/girl does not have a current vaccine type related infection (in other words, the vaccine only works when the woman/girl does not have HPV 6, 11, 16 or 18 - the viruses that Gardasil targets when she receives her first vaccine shot). o The vaccine doesn't care if the girl/woman has been sexually active, Harper said. "HPV is a skin-to-skin infection. Although the only way to get cervical dysplasia is through an HPV infection, and HPV is most often associated with sexual activity, HPV is not just spread through sex. We have multiple papers where that's documented. We know that 3-year-olds, 5-year-olds, 10-year-olds, and women who have never had sex have been found to be positive for the cancer-causing HPV types." o Therefore, for example, if a girl is positive for HPV 16 when she is inoculated with the vaccine at any age, she will not be protected against it later, Harper said. "That means it's a failure and those people are at risk for getting the HPV 16 and 18 cancers later." o The only way to test for the presence of HPV is through a vaginal swab - which is inappropriate for young girls, she said. o So what happens if the girls are vaccinated anyway, not knowing whether they were carrying the virus at the time of their inoculation? "They will not be protected if they were positive for the virus at the time they are vaccinated," Harper said. o That is why it is important to note that the vaccine has not been tested for efficacy (effectiveness) in younger girls, she said. Instead, the effectiveness was "bridged" from the older girls to the younger ones - meaning that Merck assumed that because it proved effective in the older girls, it also would be effective in the younger ones. The actual tests on the younger girls, ages 9 to 15, were only for safety and immune response, Harper said, and then only as a shot by itself, or in combination with only one other vaccine, Hepatitis B. It has not been tested in conjunction with any other shots a girl receives at about age 11, Harper said. o So far more than 40 cases of Guillian-Barre syndrome - a dangerous immune disorder that causes tingling, numbness and even paralysis of the muscles have been reported in girls who have received the HPV vaccine in combination with the meningitis vaccine. Scientists already know that sometimes a vaccine can trigger the syndrome in a subject. "With the HPV vaccine, it is a small number but higher than is expected, and we don't know if it's the combination of the two, or the meningitis alone," Harper said. o In the end, inoculating young girls may backfire because it will give them a false sense of protection. And, for both young girls and women, because the vaccine's purpose has been so misinterpreted - and mis-marketed - Harper feels that too many girls and women who have had the vaccine will develop a false sense of security, believing they are immune to cancer when they are not, and failing to continue with their annual Pap exams, are crucial to diagnosing dysplasia before it can develop into cancer. Keep getting pap smears The message to consumers, Harper said, is don't stop getting Pap smears just because you've gotten the HPV vaccine. "This vaccine is good, and it will save a huge number of lives around the world," Harper said. "But an important point is that, if women get the vaccine and then not get their Pap smears, or decide to get them infrequently, what will happen in the U.S. is that we will have an increase in cervical cancer, because the Pap screening does a very good job. "That's my main diatribe. We don't need mandatory vaccinations for little girls. What we do need to ask, though, is how long does it last, and when do you need a booster?" Message for governors For the governors of the states in this country, Harper has another message. One has to do with the fact that vaccinating little girls now is not going to protect them later. Since it can take a decade or more to even manifest itself as dysplasia, the HPVs against which this vaccine works may infect a little girl at the age she needs the vaccine most - meaning she will have to have a booster at the right point in time or she will not be protected. And, remember, it won't work at all if she was positive for the virus when she was inoculated in the first place. Merck knows this, Harper said. "To mandate now is simply to Merck's benefit, and only to Merck's benefit," she said. Merck was required to put together a database on the efficacy in children before Gardasil was approved, Harper said. But instead, the company put together four study sites that "are not necessarily representative, and may not even have enough numbers to determine what they need to know." Since she doesn't personally have access to the money Merck and GlaxoSmithKline pay for her HPV vaccine research, Harper doesn't know exactly how much either has paid Dartmouth for her work. The trials are expensive, between $4,000 and $5,000 for each patient, she said. With over 100 patients in her study, some big bucks could be in the balance, should Merck or Glaxo become upset with her for making these comments. Why, then, would she risk speaking out like this - at a time when her words very well could influence legislation across the country, and prompt legislators to drop the mandates? Isn't she afraid of losing her funding? "I want to be able to sleep with myself when I
go to bed at night," Harper said. "My concern is still,
let's get women's health better. It is still a good vaccine. But let's
be honest. Don't over-promise." |