The Gardasil Vaccine: Bad Medicine?

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Parents should think hard and do their research before submitting their young daughters as guinea pigs for the under-tested, possibly harmful human papillomavirus (HPV) vaccine.

By Anastacia Mott Austin

While making sandwiches for my children’s lunch, I glance at the calendar on the refrigerator. Tomorrow my 11-year-old daughter has an appointment with her doctor to update her vaccinations.

She's about to become a test subject for the American government's plan to inject all little girls her age with an inadequately tested, hormone-altering, and potentially carcinogenic vaccine.

The cancer that is caused by the disease she’ll be vaccinated for affects just one-hundredth of one percent of adult American women. The makers of this vaccine have made it clear that their product could not be tested for its ability to prevent this cancer.

Nobody in the study, control or placebo group, contracted the cancer. This is because its incubation period is 15-20 years; most women who have it (average age: 47) contracted the virus which caused it in their thirties. The longest test trial was less than four years. The vaccine’s makers state that the effectiveness of this vaccine is five years, maximum. This means my daughter will need at least four booster shots after the age of eleven.

What the drug makers do not mention is that this is the most expensive vaccine ever made, at $360 per three-shot series. They do not tell me about the vaccine's known carcinogenic and estrogenic compounds that will be injected into the body of my pre-pubescent little girl, or the fact that the shot has not been tested to find out if it can potentially cause more cases of cancer than it is supposed to prevent.

They do not tell me that twice as many children are having side effects such as "collapsing" as with the Tdap shot. For safety's sake, the National Vaccine Information Center advises that girls getting the vaccine should be lying down when receiving it, and should not walk or drive home after getting it.

They can't tell me what this vaccine will do to my daughter, because it hasn't even been tested on a large enough sample of children her age. They, of course, would not tell me that the makers of this vaccine have had thousands of lawsuits over previous medications they have put on the market prematurely that have caused injury and death.

Can I refuse this dangerous, experimental treatment if I do not want to have my child used in this way, so the pharmaceutical company (which will profit approximately 2 billion dollars a year on this vaccine) can find out exactly what it will do to little girls not even at puberty yet? Until recently, not if I live in Texas .

On February 2, 2007, Texas Governor Rick Perry signed an executive order mandating that all girls in the state entering sixth grade receive the new human papillomavirus (HPV) vaccine, Gardasil. Made by the drug company Merck (the makers of Vioxx), Gardasil has been heavily promoted as an anti-cervical cancer vaccine. It claims to protect against four of the 100 strains of the human papillomavirus, which some studies have shown can cause cervical cancer.

By signing an executive order, Governor Perry bypassed the Texas Legislature completely, saving himself a possibly lengthy battle to make this vaccine mandatory. By mandating the vaccine, it comes under the federal vaccine protection laws, and Merck cannot be sued if the vaccine turns out to be harmful. Why would he do this? Could it be a coincidence that three days before this decision, Merck made a campaign contribution to Perry?

This decision caused a firestorm of protest on all sides. Conservatives took offense at the implication that their little girls would become sexually active, and possibly contract a sexually transmitted disease. Others resented state intrusion into parenting decisions, claiming that the government should not be mandating anything for schoolchildren involving STD prevention. Until now, almost all state-mandated vaccines were for diseases that could be transmitted by coughing or not washing hands at school.

Feminists demanded to know; why just the girls? Where did we think these girls were getting HPV? Just because HPV is asymptomatic in men (as it is in 99.99 percent of women) and there is less cancer risk, why only vaccinate half of the population that can transmit the disease?

Others found it difficult to understand how a vaccine that had not been effectively tested for toxic side effects could be steamrolled onto the public so quickly. The vaccine was only approved by the FDA in June of last year, and almost immediately added to the childhood vaccination schedule. Why the rush?

First of all, Merck is the same company responsible for Vioxx. Accused of failing to disclose that Vioxx raised heart attack risk significantly in cardiac patients, Merck is being sued by of thousands of plaintiffs. The Vioxx disaster could end up costing Merck billions of dollars. Some have called Gardasil the HPV—Help Pay for Vioxx—vaccine.

What else could explain this rush to market a vaccine that has largely not been tested on its targeted subjects (girls aged 11-19), has not been tested for cancer-causing effects, and has not been tested long-term at all?

Merck's case studies for the HPV vaccine (paid for by Merck) included only 1200 test subjects under the age of 16, and the drug was only tested for an average of 18 months. This is not nearly enough time to test for the long-term side effects of a vaccine that will be used on young girls just entering adolescence.

The Gardasil vaccine contains Polysorbate 80 (also known as Tween 80), a known carcinogen. In addition, this ingredient has been shown to have estrogenic alterative effects and cause reproductive disturbances in rats:

Previous studies…have shown that Polysorbate 80 administered by intraperitoneal injection to neonatal female rats on days 4-7 after birth produced estrogenic effects including earlier vaginal opening, prolongation of the estrus cycle and persistent vaginal estrus. Some of these effects were evident many weeks after cessation of administration of Polysorbate 80 [Gajdova et al. Food Chem Toxicol 31(3):183-90 (1993)].

We don't know what those estrogenic effects would be on the developing bodies of pre-adolescent girls. The statistics being reported to the Vaccine Adverse Effect Response System (VAEECS) are already troubling:

"Because Merck only studied Gardasil in fewer than 1200 girls under age 16 in prelicensure 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 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"

Despite serious concerns about this vaccine, more than 29 states are currently considering mandating it for middle-school aged girls. Texas Governor Perry is not the only one to have felt the pressure by Merck's heavy lobbying.

Fortunately, the Texas legislature did not appreciate being bypassed by Perry, and responded to overwhelming feedback from parents, doctors, and educators by overturning the order mandating the HPV vaccine in Texas. Several states considering the vaccine have responded similarly with differing requirements for the vaccine, though many are still in the process of deciding the issue.

Why not use the billions of dollars that will be going to Merck, and instead fund a campaign to make HPV screening and Pap smears (far cheaper and more effective tools for fighting cervical cancer) free and accessible to everyone?

Most American parents willingly take their children into the pediatrician's office to get regularly scheduled vaccinations. They believe their doctors that vaccines are safe and effective, and will not harm their children. They do not ask questions about the ingredients in the shots, or what effects they might have on young children.

I am not one of them. Luckily, I live in California, not Texas, and I can still say no to this vaccine.

I look again at the calendar on the fridge. Angrily, I open the drawer next to it and take out a big, black marker. I cross out the appointment time with a decisive black stripe.

We will never wait outside of a doctor's office for an experimental and dangerous treatment that has not been properly tested. Being an informed parent is part of my duty to my children, and I will never take on blind faith the recommendation of someone who profits from his or her own advice.

I do not trust the pharmaceutical industry to make decisions for me about my children's health, and I cannot honestly understand those who do.

Why? Because it's bad medicine.

By Buzzle Staff and Agencies
Published: 7/1/2007