Questioning the safety of Gardasil

All Alexa and Erich Fritz wanted was to protect their little girl.

So when their daughter’s Culpeper pediatrician suggested a fairly new vaccine that’s supposed to prevent certain types of cervical cancer, the Reva couple reluctantly allowed the physician to inject two doses of the Gardasil vaccine.

“The worst thing is that I did tell the doctor no and let myself get pushed into allowing this,” Alexa said. “The guilt is awful. I wish I had taken the stupid shot and not her.”

Merck & Co., a global research-driven pharmaceutical company that produces Gardasil, defends its product, and when asked about the vaccine, product communications representative Pam Eisele points to the company’s online statement.

“Nothing is more important to Merck than the safety of our medi-cines and vaccines. We are confi-dent in the safety profile of Gar-dasil,” the statement reads. “While no vaccine or medicine is com-pletely without risk, leading health organizations throughout the world including the U.S. Centers for Disease Control and Prevention and the European Medicines Agency have reviewed all of the safety information available to them about Gardasil and continue to recommend its use.”

Approved in June 2006, a rec-ommended three doses of the vac-cine is usually given to young girls and women ages 9 to 26 within a six-month period to protect against four types of human papillomavi-rus, a sexually transmitted infec-tion.
Instead, the Fritzs claim, the vaccine has caused more problems than it’s worth.

Alexa and Erich described their daughter, Haley Fritz — an 11-year-old sixth-grader at Floyd T. Binns Middle School — as a healthy, active preteen until last summer.

After being given the vaccine, Alexa said, her daughter now suffers from a laundry list of symptoms such as headaches, muscle pains and anxiety, sleep-walking, chest pains, stomach and backaches, hot flashes, migraines, rheumatoid arthritis and fi-bromyalgia, a chronic widespread pain.

Today, the lethargic preteen is homebound and on a specialized diet; she also has a new Freder-icksburg-based pediatrician.
“So I can only eat healthy foods and for a kid that’s only 11¾ years old, it’s pretty hard,” said Haley, who received her first shot in July and second in
September. “Seeing all the kids at school with their sugarful, glutenful lunches, I almost die. I’ve been switching from this medicine to that and from diet to diet, but still we ha-ven’t found a cure.”

Gardasil researchers recognize the side affects connected to the vaccine and listed a few on its Web site — pain, swelling, itching, bruising, headache, fever, nausea, dizziness, vomiting and fainting. Some allergic reactions are diffi-culty breathing, wheezing, hives and rash.

Sharing information
The Fritz family isn’t alone in its claims against the vaccine.

Two North Carolina women — Marian Green and Rosemary Mathis — created the Truth-AboutGardasil.org Web site in 2009 after they say their children became sick from the Gardasil shot.

Like Alexa Fritz, countless moms share their horror stories on Web sites such as this one and the National Vaccine Information Center, a national, nonprofit educational organization and vaccine-safety watchdog.

For instance, Teresa Allen of Gig Harbor, Wash., writes about her daughter, Kristyn, 16, who began suffering from back pain, numbness, headaches, chest pains, and weakness immediately after receiving the vaccine.

“This vaccine has completely changed our lives. My daughter is scared every day that she will be another ‘one less’ living,” Teresa wrote on the TruthAboutGar-dasil.org. “Merck should be ashamed. Our daughters are NOT guinea pigs for the big pharmaceu-tical companies.”

Shannon Shrag talks about her daughter, Gabrielle, 15, and how she suffers from some of the same symptoms as other young girls who received the vaccine.

Gabrielle endures excessive fatigue, loss of concentration, memory loss, etc.

“Gabi has been robbed of a normal life,” Shrag wrote on the NVIC site. “She may never have the opportunity to achieve her dreams. I may never get the oppor-tunity to watch her be all she can be as a young woman, a college student, a wife and a mom. All of this because of a vaccine that was intended to save lives of millions, a vaccine that was fast-tracked and lacked long-term safety studies.”

Vaccine stats
Since Sept. 1, the Vaccine Ad-verse Event Reporting System — an early-warning system that helps the Centers for Disease Control and Prevention and the U.S. Food and Drug Administra-tion detect possible side effects or adverse events after vaccination — has received 15,037 reports of “adverse events” following
Gardasil vaccines in the U.S.

So far, more than 26 million doses of the vaccine have been distributed countrywide.

According to the CDC Web site, 93 percent of the events were considered non-serious and 7 percent were classified as serious.

As of Sept. 1, 44 women have died after receiving the vaccine, according to the CDC. Twenty-seven of those reports were confirmed and 17 remain unconfirmed due to no identifiable patient information.

Before licensing its vaccine, Gardasil was studied in five clinical trials using 21,000 girls and women ages 9 through 26.

“Based on all of the information we have today, CDC continues to recommend Gardasil vaccination for the prevention of four types of HPV,” the CDC Web site states. “As with all approved vaccines, CDC and FDA will continue to closely monitor the safety of Gardasil. Any problems detected with this vaccine will be reported to health officials, health care provid-ers and the public, and needed action will be taken to ensure the public’s health and safety.”

In its conclusion, VAERS states, “There is no proven causal associa-tion between the vaccine and the adverse event. The only association is in time, meaning that the adverse event occurred sometime after vaccination. Therefore, we cannot conclude that the events reported to VAERS were caused by the vaccine.”

Opposing opinions
Dr. Peyton T. Taylor Jr., a pro-fessor of OBGYN and internal medicine (global health) and dep-uty medical director of the cancer center at the University of Vir-ginia, said although there are serious reports about the vaccine, they are low in frequency.

“So parents have to balance the low risk of complications versus protection,” said Taylor, who isn’t familiar with the Fritz case. “I do think the vaccine has a very favorable safety profile.”

In places where legislation is pending to make the vaccine man-datory for school entrance, there is a parental opt-out policy.
The Parents and Citizens Committee To Stop Medical Ex-perimentation in D.C. uses slogans such as “If in doubt, opt-out,” and “No HPV shots 4 me” on its
Web site to warn parents about what they describe as a dangerous vaccine.

“I had some initial concerns about this,” said committee mem-ber Peter Tucker, who has re-searched the vaccine extensively and posted the committee’s report on its Web site, “and there is no evidence that giving a young girl the vaccine will prevent cervical cancer decades down the road. It’s more effective to prevent HPV when you don’t get the vaccine.”