Gardasil is “Mostly” Safe, But Is It Effective?
Here in Virginia, health officials are pushing the vaccine that protects against HPV. As the Washington Post reports, the Commonwealth wants Gardasil administered to every girl entering the 6th grade. Parents here can opt out simply by refusing to give their girls the shot.
But fears of adverse affects still abound. This month, a study in the Journal of the American Medical Association showed that in the 2.5 years between June 2006 and December 2008, there were
12,424 reports of side effects, or 54 reports per 100,000 doses given. That included 32 reports of death, or 1 per 1 million girls vaccinated, though it’s unclear whether the vaccine or something else was to blame.
An NPR report also stated that we’re not sure how many of those deaths were due to preexisting conditions in the teen girls, such as blood clots:
All of these people had a known risk factor for having blood clots. Most commonly was that they were on some sort of estrogen birth control. But obesity, traveling, immobility and some of these people had genetic risk factors for getting - for having blood clots, as well.
So…we’re blaming the girls for their deaths? For their previously unknown medical conditions? Not only are we as yet uncertain of Gardasil’s safety, we also have no clue about its efficacy, especially long-term.
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These adverse effects were reported by physicians to the Vaccine Adverse Events Reporting System (VAERS). JAMA notes that this is a voluntary, passive reporting system, so the data is limited.
They point out that only systematic, prospective, controlled studies will be able to distinguish the true harmful effects of the HPV vaccine. These limitations work both ways: it is also difficult to conclude that a serious event is not caused by the vaccine.
After some of these adverse effects, the FDA recently ordered that the manufacturer of Gardasil, Merck, must now add a few more warnings to its labeling, including:
fainting, tonic-clonic (jerking) movements, and “seizure-like” reactions.
Dr. Charlotte Haug, writing an editorial for JAMA this month, points out a few other problems with HPV vaccines overall.
- There are over 100 different types of HPV. Yes, HPV is the most common STD, at an estimated 79% over a lifetime. Most of these go undiagnosed and many clear up from our own immunity. Women get annual Pap smears to check for precancerous cells associated with cervical cancer. Nearly all cases of cervical cancer (and some cases of penile cancer) are caused by HPV.
- Gardasil and other HPV vaccines operate under the theory that if the STD spread can be prevented, so can cervical cancer.
- There are over 11,000 cases of cervical cancer diagnosed each year and 4,070 deaths.
- Gardasil only protects against two types of HPV, responsible for about 60% of cervical cancer cases. Approximately 15 of the 100 types of HPV are cancer-causing.
- Before Gardasil was approved by the FDA, drugmaker Merck tested about 2,500 with the vaccine and followed up one month and again 3 years later to check the incidence of cervical cancer and HPV infection. The girls and women tested were between 16 and 23 years old and with a lifetime history of sexual partners bewteen 0-4. Gardasil was 100% effective against cervical disease and had a maximum efficacy of 34% when it came to “lesions”.
- HPV vaccines are recommended for girls as young as 9 and has only been tested on a few hundred 11- and 12year-olds. And we’re not sure about long-term efficacy, as Dr. Haug states in her editorial:
In a few women, [HPV] infection persists and some women may develop precancerous cervical lesions and eventually cervical cancer. It is currently impossible to predict in which women this will occur and why. Likewise, it is impossible to predict exactly what effect vaccination of young girls and women will have on the incidence of cervical cancer 20 to 40 years from now. The true effect of the vaccine can be determined only through clinical trials and long-term follow-up.
It’s on the Recommended Immunization Schedule for girls aged 7-18, and drugmaker Merck is hoping that the FDA will soon approve it for boys. After all, we’ve already got parents circumcising boys over the fear of penile cancer. Why not add a vaccine to the mix?
Image: Wikimedia Commons
I am still doubtful of the effectiveness of Gardasil verses safe sex practices and routine Pap smears.
What I really don’t get about Gardasil is that there is strong indication that it only lasts about 3-5 years but the push is to give it to *MIDDLE SCHOOLERS*????? The average age for girls to lose their virginity in the U.S. is 17.3 and nearly half of girls are still virgins on their 18th birthdays. So the shot will wear off right about the midway part of high school, just when the average girl would actually start to need protection against HPV.
Real smart idea…
The language of this article is alarmist - no one in the study is “blaming the women” for having adverse reactions - they were stating that pre-existing health problems like blood clots made it difficult to determine whether the vaccine was the root cause of the complications.
We also have slightly more than “no clue” about it’s effectiveness at preventing HPV, even if that doesn’t necessarily translate into solid data regarding it’s ability to prevent the cancers linked to HPV. HPV has other complications besides cervical cancer (sterility and death are on the list) so it’s worth preventing the infection even if it turns out that doing so doesn’t protect from the cancer.
17.3 may be the national average age at which student have sex, but it’s not the average for Virginia, where this program is being considered and it varies widely from the average depending on social grouping criteria (race, economic status). It’s naive to suggest that since the average is 17.3, middle school is “too soon.”
Gardasil _is_ a safe-sex practice, and the risks associated with it are lower than the risk of contracting an STD _despite_ using a condom.
My 13 year old daughter was injured by Gardasil and completely disabled for the past year. Merck got it right when they used the slogan “One Less” for Gardasil. Because of Gardasil, my daughter was “One Less”. She was “One Less Student”, “One Less Active Child”, “One Less in every aspect of her life”. Take it from a mother who has spent the past year sitting by my child’s beside wondering if she would die in her sleep. INVESTIGATE BEFORE YOU VACCINATE. DO NOT trust your doctor to make this decision. If you want to understand Merck’s role in the medical community, investigate some of their former wonderdrugs such as VIOXX and then marvel at how many people died from it before it was pulled off the market. The CDC AND FDA need to do their job and get this off the market before more children are harmed. The public is not aware of VAERS and the #’s are grossly understated. I have had to tell my child’s doctors about VAERS and make them file reports or she would not be one of the current statistics in VAERS. Even then, her information has not been entered correctly so I know that VAERS is not what it should be.Please do not let this happen to your child.
Crosius: You seem to like commenting on my vaccine blogs. You are clearly pro-; I am obviously not.
Merck tested Gardasil for effectiveness against cervical disease after 3 years. Because HPV doesn’t immediately cause cervical disease or cancer (hence annual Paps), that is a poor indication of whether it works. Plus, Gardasil didn’t protect well against “lesions” (genital warts). Did you read that list above? Those aren’t my facts; those are the facts in the Journal of the American Medical Association.
Read the comment following yours and you might understand the cause for alarm.
And because we haven’t tested the HPV vaccine long-term, we DON’T have a clue about long-term efficacy. Will women need a shot again in their 20s? Their 30s?
And if it only protects against 2 of the cancer-causing forms of HPV and 2 that cause warts (of the hundred), I’d say that’s hardly a cause for celebration.
Ask the parents of the girls with adverse effects and see how they feel about the protection Gardasil has given their girls.
It’s not alarmist to be skeptical.
[...] according to CBS. The rate of serious adverse events on par with the death rate of cervical cancer. Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical [...]
A friend told me about his professor’s daughter who, soon after receiving the Gardisil vaccine, came down with a debilatating disease and, soon after, died. There is a website about her death and the possible link to the vaccine http://jenjensfamily.blogspot.com/.
For every story that tells of someone dying from the vaccine, there is going to be another story that tells of someone dying from cervical cancer. Like this story:
http://www.mydeathspace.com/article/2006/11/09/China_Stogner_%2823%29_died_of_cervical_cancer
and this one:
http://www.celebitchy.com/42471/jade_goody_died_of_cervical_cancer/
I am twenty-two. I grew up in Nashville, TN where the majority of my friends had sex before their 18th birthday. A large amount of people had sex in middle school. I know someone with cervical cancer who did not get the vaccine. I have yet to ask her whether or not she wishes she got it, but I think I know what her answer would be.
I understand the point behind preaching safe sex instead of pushing the Gardasil shot, but the truth is, kids are not going to listen. They never have and probably never will. Before the age of 25, kids do not understand the consequences of their actions- death and cancer are only something talked about in a far away place, away from their reality. The same reason college kids binge drink, chain smoke, and snort cocaine- they cannot grasp long-term effects of their actions. So how can we expect preaching safe sex will change their ways?
Getting the Gardasil shot is a risk. As it says above, 1 per 1 million girls vaccinated died from the vaccination. But, it is a greater risk to not get the vaccine. 3, 924 women die every year from cervical cancer (http://www.cdc.gov/cancer/cervical/statistics/). There are 3,301,112,087 women in the world. That means 1 in every 84,117 women die from cervical cancer.
If you are a virgin or have protected sex, then by all means, don’t get the vaccine. If you personally know someone who has died or had serious side effects from the vaccine, then I don’t blame you for not getting it- I wouldn’t either. But if you have children from the ages of 15-25, I guarantee you a lot of them are not virgins and are not having safe sex. Try talking to them, sure. But if you feel that doesn’t work, get the vaccine.