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What Every Parent Should Know About Gardisil

On June 8, 2006, the United States Food and Drug Administration approved a vaccine against human papillomavirus (HPV) marketed by Merck and Company. Almost immediately, television commercials appeared touting Gardisil, the new “cervical cancer vaccine.” Web campaigns were launched to spread the word about HPV, which can cause cervical cancer, and to create awareness about the vaccine, recommended for girls and women ages 9 to 26. The marketing campaign has left some parents and young women scratching their heads, uncertain as to how HPV is spread, what the vaccine actually prevents, and whether they or their daughter need it.

What is HPV?
Human papillomavirus (HPV) refers to a group of viruses that includes more than 100 different strains or types. Approximately 30% of HPV strains are sexually transmitted and can infect the genital areas of men and women. Most people who become infected with HPV will have no symptoms and will unknowingly carry the virus. Some strains of HPV cause genital warts, and the presence of HPV increases the risk of developing cancer of the cervix, anus, or genitals.
According to the Centers for Disease Control, more than 50% of the adult population is infected with a sexually transmitted type of HPV, though only a fraction of that group has experienced symptoms. HPV is heavily linked to the development of cervical cancer; particularly HPV types 16, 18, 31, 33, and 45, as well as a few others.

About Cervical Cancer
There are two main types of cervical cancers: squamous cell carcinoma and adenocarcinoma. About 80-90% of cervical cancers are classified as squamous cell carcinoma, while the remainder fall into the adenocarcinoma category. Adenocarcinomas are becoming more common among women born in the last 20 to 30 years, while the incidence of squamous cell carcinoma is decreasing.

Pap smears, designed to spot cellular changes in the cervix, are recommended annually. Because of this screening tool, the incidence of death from cervical cancer has declined by about 4% annually since 1952, although 2007 is projected to see a rise in cervical cancer diagnoses. The American Cancer Society estimates that in 2007, about 11,150 cases of invasive cervical cancer will be diagnosed in the United States. About 3,670 women will die from cervical cancer in the United States during 2007. According to Dr. Joan Walker, a gynecologic oncologist at OU Medical Center, this year an estimated 160 Oklahoma women will be diagnosed with cervical cancer that could have been prevented by the vaccine.

What is Gardasil?
Gardasil is a new vaccine that immunizes against the four most common types of sexually transmitted HPV (Types 6, 11, 16, and 18). Types 6 and 11 are considered “low-risk” strains, meaning that they are unlikely to lead to pre-cancerous changes, though these strains cause about 90% of genital warts. Types 16 and 18 cause about 70% of cervical cancers. The vaccine is most effective when used prior to any exposure to the virus, hence the recommended age range of 9-26. Gardasil is a series of three injections (costing approximately $120 per shot) over a six-month period.

In Oklahoma, females age nine through 18, with parental permission, may be vaccinated through the Vaccines for Children Program. To receive the free vaccine at the Oklahoma County Health Department, girls must meet these criteria:

  • be uninsured or have insurance which doesn't cover vaccines, or
  • be Native American, or
  • be on Medicaid.

Girls who don't fit the above guidelines need to see their physician for the vaccine. Private insurance covers the vaccine, typically paying around 80% after a deductible is met. The vaccine is currently voluntary in most states, though some have introduced legislation to make the vaccine mandatory for all girls prior to entering the sixth grade. Texas Governor Rick Perry signed such a law in February and now all girls entering sixth grade are required to receive the vaccinations, though parents may opt out by signing an affidavit objecting to the vaccine for philosophical or religious reasons.

Important Considerations
The prospect of mandating a vaccine against a sexually transmitted disease for preteen girls does not sit well with some parents. Some fear that it will be one more strike against abstinence education, while others argue that they hesitate to proceed with any vaccine that lacks data on its long-term effects. Others simply feel it is a decision that needs to be made within a family. While the majority of moms polled (unscientifically) for this article conceded that they would probably vaccinate their daughters (or encourage vaccination in their older daughters), most did so with reservations.

Marketing campaigns for Gardasil have omitted important information about HPV and how it is spread. The television ads show attractive teenagers while a voice-over gives information about the “vaccine that can prevent cancer.” While Gardasil may indeed be an effective tool for reducing the likelihood of developing cervical cancer, parents and older patients need far more information to make an informed decision than what is provided in the advertising. Valuable information can be found at Cancer.org and the Centers for Disease Control website, cdc.gov. Questions and concerns should be addressed with health care providers.

Dr. Walker points out the continued importance of regular pap smears and HPV screenings in addition to the vaccine, but feels the vaccine will have a dramatic impact on cervical cancer rates, perhaps eliminating 70-75% of all cervical cancers. “It will take 10 years to see the effect of lowering of CIN 3 [precancer] rates and 20 years to see the decline in cancer rates. But I am excited to watch it happen.”

HPV: An Edmond Mom Tells Her Story
How HPV affects my life

I thank the Lord daily I'm okay. I give him thanks for allowing me to have a son. It has been a long road to obtaining my dream of motherhood, but I've been blessed and my dreams have come true. Unfortunately, this is not the case for many women in this world who've contracted HPV.

When I was 18 years old, I found out I had cervical dysplasia, abnormal cells on the surface of the cervix considered to be a precancerous condition, and would have to have outpatient surgery to remove the abnormal cells. You can only imagine the shock and horror not only I, but my family, felt. How was it possible at such a tender age to receive such devastating news? Unbeknownst to me, I had contracted HPV, human papillomavirus, a sexually-transmitted disease that causes the majority of cervical cancer cases.

No one deserves the lifelong scare of having HPV. I thought I was being safe. I had a steady boyfriend whom I loved-puppy love, but the love a teenager feels seems real and true at the time. I had no idea making the choice to be with him in a sexual manner would lead to health problems I never could have imagined.

Once diagnosed with HPV and cervical dysplasia, I still had no understanding of the virus, the potential problems it could cause, or how it could possibly destroy my chances of ever realizing my life long dream of being a mother. My doctor, a fantastic lady esteemed in her field, played it down as though it was not a big deal. I now believe she was merely trying to keep me from being scared out of my mind. Besides, HPV is so common amongst women I imagine to a physician who deals with the virus daily, it is the norm. I do wish I would have been given more information at the time of diagnosis so I could fully understand what was happening to my body and what would be my reality from then on.

Between the ages of 18 and 25, I had numerous biopsies taken. I had three surgeries to remove abnormal cells so they would not turn in to cancer. I had multiple other procedures performed to remove the pre-cancerous cells and to test for further problems and the potential of it spreading to my uterus. I can't explain the physical pain I endured, not to mention the emotional turmoil of always having the lingering question in the back of my mind-do I have cancer and will they have to do a hysterectomy before I have the chance to have children? It was scary. It was heart wrenching. It changed me forever.

I have not had a bad pap smear in almost seven years. My mom helped me research why my dysplasia kept reoccurring and one thing we learned was tobacco smoke really aggravates the problem. I smoked a pack a day for 10 years. Once I learned this important fact, I had my good solid reason to put down the cigarettes forever. I have now been a reformed smoker for almost six years and I have not had a bad pap smear result since!

There is no cure for HPV. It can come back at any time. The scare will always exist for me. There have been other circumstances of the disease that have impacted my life. I have an insufficient cervix due to having had so much of it removed. When I finally got pregnant with my son, I had to talk to my doctor about my medical history and together we decided I would need a cervical cerclage. In my fourteenth week of pregnancy, I literally had my cervix sown shut to support the growing baby in my womb so I would not miscarry. If I had not had this done, I most likely would have lost my son.

At 27 weeks, I went into pre-term labor. I can't say for 100% certainty it was because my now very small cervix was having a hard time supporting the baby in my womb, but the question is always there. At 30 weeks, I delivered my son despite the doctor's best attempts to keep him from being delivered early. He went on to spend the first month of his life in the neonatal intensive care unit. As I write this, he is 19 months old and is thriving! He is a blessing and a wonder to behold and it truly my miracle baby. Who knows for sure if my problems from HPV are part of the reason he came into this world before his tiny body was fully ready, but I've carried tremendous amounts of guilt and have had to work long and hard to forgive myself and be thankful he turned out to be healthy.

I hope and pray I'll be able to have more children, but I don't know. My annual exam is quickly approaching and each year the dread and fear of my pap results looms above me like a dark cloud. I can't begin to tell you of the guilt, shame, depression, and emotional damage I've experienced through it all. It has taken over a decade for me to realize I didn't deserve this. I was not being punished. I'm not dirty or bad. It happens to so many women and yet the education and the information, as well as the awareness still do not exist to prevent this vicious disease from destroying many more lives.

As parents, we have a responsibility to educate our children about HPV, especially our daughters who potentially bear the brunt of this wicked virus. Research the virus. Study it and the devastation it can cause and in turn, educate your children. Help them make better choices, or at least educated ones. Be glad and rejoice you've done all you can to help them avoid a life long struggle of the potentially fatal diagnosis of cervical cancer.

If you think HPV will not affect you, your family members, or your children, think again.
HPV is so common that by age 50 as many as 8 of 10 women who have sex will be infected with it. There are more than 100 types of HPV. The most dangerous types are HPV 16 and 18. Together, these two types of HPV account for an estimated 70 percent of cervical cancer cases.
(Above statistics from: http://www.makethecommitment.org/cervical_cancer/cause.asp)

Shannon Fields is a freelance writer and a Certified Pharmacy Technician at Innovative Pharmacy Solutions. She holds a BA in Psychology with a minor in English from the University of Central Oklahoma. Shannon lives in Edmond with her husband and two daughters.

4 comments (Add your own)

1. GARDASIL KILLS wrote:
GOOGLE

GARDASIL and DEATHS

STUPID

Monday, February 09, 2009
Gardasil Death & Brain Damage: A National Tragedy
by Barbara Loe Fisher

The tragic story of Gardasil vaccine is one that is playing out real time in the homes of trusting parents, who thought they were doing the right thing to try to make their daughters "one less," and in the 21st century cyberspace forum of public opinion as well as on television. On Feb. 6, CBS-TV Evening News released NVIC's new report on Gardasil vaccine risks. (watch VIDEO here)

Today, NVIC launched a petition and issued a national press release calling on President Barack Obama, his Administration and Congress to investigate the fast track licensure and universal use recommendation of Gardasil in 2006 and the dismissal of more than 10,000 reports of Gardasil-related reactions, injuries and deaths to the Vaccine Adverse Events Reporting System (VAERS) as a "coincidence" by federal health officials.

NVIC's latest Gardasil risk report comparing the number and severity of adverse events reported to the federal Vaccine Adverse Events Reporting System (VAERS) through November 30, 2008, reveals that death and serious health problems such as stroke, blood clots, cardiac arrest, seizures, fainting, lupus and rechallenge cases are reported three to 30 times more frequently after Gardasil vaccination than after meningococcal (Menactra) vaccination. If the deaths and serious injuries being reported after Gardasil were only a "coincidence," there would be little or no difference between the frequency and severity of vaccine-related adverse events between two vaccines if the vaccines were equally reactive and the number of doses were roughly the same.

Gardasil and Menactra vaccines were licensed within a year of each other and recommended by the CDC for universal use in 11-12 year olds. Although Menactra is given to boys and girls and has already been mandated in many states for high school and college entry, Gardasil is only given to girls and is not yet mandated. Menatra is given as one-dose series and, by February 25, 2008, the CDC reported that about 15.5 million doses of Menactra had been distributed in the U.S. Gardasil is given in a three dose series and the CDC reported that, by July 2008, about 16 million doses had been distributed in the U.S.

This means that about 15 million doses of Menactra were given to about 15 million boys and/or girls and about 16 million doses of Gardasil - if every girl got three doses - were given to about five million girls. It is individuals - not doses of vaccine - who collapse, convulse, become paralyzed, have heart attacks, develop lupus and other chronic health problems after being vaccinated. The fact that death and serious health problems are reported 3 to 30 times more frequently after Gardasil than after Menactra is highly significant and it is irresponsible for federal health officials and Merck to blow it off as unimportant.

What is sad is that the average junior high or high school student could do this VAERS analysis and come to the same conclusion. It does not take an M.D., Ph.D. or math genius to figure it out. In the hours before the CBS News report was broadcast, the best answer that Merck could come up with to address the differences between adverse events associated with Gardasil and Menactra was this:

"It's important to remember that the proven benefit of GARDASIL is that it helps prevent cervical cancer caused by the two virus types responsible for most cases of cervical cancer. Nothing is more important to Merck than the safety of our products and we carefully monitor the safety of GARDASIL on a routine basis. Experts at the FDA and CDC also continue to review data and, as recently as four months ago, said "GARDASIL continues to be safe and effective, and its benefits continue to outweigh its risks." NVIC is not a medical organization and has a long history of raising concerns about vaccines that are in direct conflict with the opinion of leading medical experts. We encourage consumers to get reliable information about the safety of vaccines from www.cdc.gov."

No, it doesn't take a doctor, health official or "medical organization" to do the math. What it takes is caring about every life - whether that life represents a baby, toddler, child, teenager, young adult, adult or senior citizen - because every life is important and nobody deserves to be written off by a drug company or government agency as an expendable casualty of public health policy.

Gabrielle, the 15 year old gymnast, honor roll student and cheerleader from Wichita, Kansas, who talks about how her health has been destroyed by Gardasil vaccine in the CBS report and in the NVIC video press release, spends most of her time at home or at doctors' offices now. A few weeks ago, her school voted her Homecoming Princess. On Saturday, she tried to go to the Homecoming dance. As she was getting dressed, she collapsed with seizures and severe abdominal pain. The medication she has been taking to try to control the seizures she developed after Gardasil vaccination caused her to develop kidney stones. She was rushed to the emergency room and hospitalized.

In the past 27 years, the stories of death and brain damage that have been reported to the National Vaccine Information Center have never changed. Whether the vaccine victims are 15 months old or 15 years old, the stories are the same: a trusting parent took a bright, healthy child to a doctor for a routine vaccination and the child was never the same again.

Gardasil vaccine was inappropriately fast tracked and licensed by the FDA and recommended by the CDC with too little attention paid to the reports of brain and immune system dysfunction that developed after vaccination in pre-licensure clinical trials. That same cavalier attitude toward Gardasil-related deaths and serious health problems, which have been experienced by many girls and young women after licensure, is inexcusable.

Americans are losing trust in pharmaceutical companies making drugs and vaccines and in federal health agencies, whose responsibility is to ensure that drugs and vaccines licensed for public use are safe, effective and necessary. If those responsible for protecting our health are not going to step up to the plate and do their jobs, then it is up to the people to do it.

At www.NVIC.org you can sign the Investigate Gardasil Vaccine Risks Now! petition, read NVIC's new report on Gardasil risks, and check out our new website that makes it easier to navigate and find information to prevent vaccine injuries and deaths.

In 2009, I have a sense of déjà vu, as the story of Gardasil vaccine plays out real time. There are striking parallels between how those operating the mass vaccination system reacted in the 1980's to persistent reports that DPT vaccine was harming more children than originally assumed and the way they are reacting now to persistent reports that Gardasil is more reactive than it was originally assumed. Assumption of safety is no substitute for proof of safety. And turning away from human suffering in order to protect the status quo is not the way to run a government that needs the trust and support of the people.

In the 18th century, Queen Marie Antoinette looked down at a starving people pleading for bread to stay alive and said "Let them eat cake." It is time for everyone in government, industry and medicine to take a different approach to persistent reports of vaccine injuries and deaths or risk metaphorically suffering the same fate that ended the monarchy in France. In the 21st century, today's peasants don't have pitchforks - they have laptops, desktops, smartphones and the internet.
Posted by Barbara Loe Fisher at 12:49 PM

August 2, 2009 @ 5:10 PM

2. GARDASIL KILLS wrote:
KILLS YOU

KILLS YOUR DAUGHTER

CAUSES AUTO-IMMUNE DISEASES

HUNDREDS OF DEAD AND DYING WOMEN

KILL YOUR DAUGHTER With GARDASIL. STUPID

August 2, 2009 @ 5:11 PM

3. Sandra Rice wrote:
I had my daughter of 12 years old vaccinated last year. I actually waited a year before doing it to see if there were problems. NOW, I am extremely upset. Have I just caused enormous problems for my daughter. She had no reaction at the time of the shots. But will I see signs of problems later? When do the reactions begin? RIGHT away or later? Where can I get my questions answered? I am very upset now. I, myself, have battled breast cancer twice. It is a very bad process to go thru. So, I thought if I could protect my daughter from any type of cancer I would. NOW, what have I done? Is the drug company and the FDA going to do? They are messing with our children now. Mess with me, but not my kids.

August 19, 2009 @ 10:15 AM

4. wrote:
My daughter's pediatrician was trying to bully me into getting her the vaccine. . she even said, "Do you WANT your daughter to get cervical cancer?" right in front of my child after I'd refused the vaccine. I was SO angry!

January 21, 2010 @ 12:30 PM

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