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Do You Trust Gardasil?

A friend e-mailed me yesterday saying her college-student daughter had reported that 200 girls/women had died after receiving Gardasil, the three-shot vaccine aimed at preventing cervical cancer by protecting against the human papillomavirus (HPV) that can cause it.

"Any truth to that?" she wondered.

Reports and rumors about Gardasil's adverse effects, including deaths, have been circulating on the Internet (and apparently on college campuses) for months. In fact, the vaccine's been controversial longer than it's been available: Even before Gardasil's June 2006 FDA approval, conservative groups took aim, arguing that the vaccine -- which is to be administered to girls and women ages 9 to 26 -- would promote promiscuity by making sex seem safer.

Other critics suggest that the vaccine could ultimately increase the damage done by cervical cancer, which is almost always treatable if it's caught early by a PAP smear; some women, they say, may feel complacent about their cervical-cancer risk and skip the PAP smears. Gardasil doesn't protect against every strain of HPV, so even vaccinated women remain at risk and still need that annual screening. Gardasil doesn't protect against other sexually transmitted diseases, either; some worry that young women will assume it does and not insist on condom use or take other steps to actually protect themselves from STDs.

Many have objected to the aggressive marketing and lobbying campaigns mounted by Merck, Gardasil's maker, noting that those efforts may have unduly swayed pediatricians to recommend the vaccine, patients to ask for it, and state legislatures to require its administration to school-age girls.

For now, I'm relying on the information provided by the U.S. Centers for Disease Control and Prevention (CDC) on its Gardasil-safety page. In sum, the CDC says as of June 30, 20 deaths among females who had received Gardasil had been reported, but that in none of those instances could the death clearly be linked to the vaccine. You would expect some young women in this age-group to die, whether or not they had received the vaccine.

I've been watching all of this closely: At the strong recommendation of my highly trusted pediatrician, my husband and I decided to have our 14-year-old daughter receive the shots last year. She suffered no serious ill effects, except for a lot of pain that started at the injection site and migrated around her body in the days after the shots. Ask anyone who's had these shots: They hurt.

Would we have made the same decision if we'd heard about Gardasil-related deaths? At the time, we felt good knowing that we'd taken a step to keep our daughter healthy long after she leaves home. But for a moment, I found myself wondering: Were we overly influenced by Merck's TV ads -- the ubiquitous ones promising "One less"? Worse, might our pediatrician been caught up in the Gardasil hype?

Those kinds of questions cross every parent's mind as we make decisions about preventive treatment for their children. That's when it's time to distinguish online rumor from the scientific information that the CDC readily posts online. Here's how the CDC review concludes: "FDA and CDC continue to find that Gardasil is a safe and effective vaccine that will potentially benefit the health of millions of women by providing protection against the types of HPV that cause the majority of cervical cancer, genital warts, and other HPV-related diseases."

I don't in any way want to diminish the anguish parents who have lost daughters must feel. But when it comes to choosing treatment, you have to put science over speculation. The greater danger, it seems to me, lies in being scared away from potentially life-saving shots by Internet (or campus) rumors.

Have you had the shots yourself? Or, like me, have you arranged them for your daughter?

By Jennifer LaRue Huget  |  August 19, 2008; 7:00 AM ET
Categories:  Women's Health  
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Comments

Any vaccine can cause adverse reactions. Even the polio and smallpox vaccine had fatalities but their risk to benefit ratio made them far more beneficial than not. The same is true for the Gardasil vaccine. It is a beneficial vaccine and not some entry into promiscuity or something that makes sex safer.

If your daughter was not promiscuous before being vaccinated with Gardasil, she will not suddenly become promiscuous. If your daughter did not engage in sexual intercourse before this vaccine, she will likely not change her behavior after receiving this vaccine. In short, like the Hepatitis vaccine, the MMR vaccine, this vaccine does not change behavior but provides protection.

Even if a young woman remains a virgin until marriage, she can be infected by HPV (if her husband carries the infection). Even if she is in a monogamous relationship, she can still be at risk for cervical cancer if her partner has been exposed or carries the virus. You cannot look at a male and know if they have or do not have this virus.

If you want your daughters to be safe, then teach them safe sex practice and protection. If you want your daughters to make good choices, then have an honest and open discussion with them about these issues but do not confuse protection against HPV with making moral or personal choices. These two entities are mutually exclusive.

It is very sad to see a young woman with genital warts or cervical cancer (single or married) because she believed that a vaccine would somehow corrupt her morals.

Posted by: nb3c | August 19, 2008 6:57 AM | Report abuse

I got the series of three shots as soon as they were released on the market and experienced no pain or side effects. My gynecologist told me that about three out of five of her patients has contracted HPV and that I'm one of the few patients she has under 30 who doesn't have the virus. I'm hoping it stays that way, even though I'm only protected against two strains.

Posted by: SWester | August 19, 2008 7:31 AM | Report abuse

My daughter (12) has finished the series of shots last year. She said it didn't hurt any worse than the TDaP she had to get last year, too. And along with the chicken pox shot and flu vaccine, anything to keep her healthy is okay by me.

I am planning on having my 10 year old daughter vaccinated next year, too.

Posted by: pamsdds | August 19, 2008 7:41 AM | Report abuse

I will not vaccinate my daughter and find the idea of a mandated vaccine to be outrageous. A LOT of the routine vaccinations that are done are totally unnecessary. Like the hepatitis B vaccine that all infants are given in the hospital just as a matter of course unless you specifically opt out of it.

Why would you need to protect an infant from a blood borne STD? If you know that the mother doesn't have it? But millions of babies are given this vaccine just as a matter of course. It's stupid and just a profit generator for the pharmaceutical companies.

So too the rotovirus vaccine...a new vaccine against rotovirus that 95% of children will contract anyway, whether they are vaccinated or not, and that has some awful potential side effects.

Regular PAP smears and advising my daughter on the dangers of promiscuity, along with the need for safe sex will have to suffice as her protection against the disease.

By the time my daughter is of the age where the vaccine would even be an option, there will be more research into it, and the longterm effects.

I hope that your daughters aren't the victims of what are essentially live human trials...

Posted by: KL_VA | August 19, 2008 7:55 AM | Report abuse

Gardasil is just the latest moneymaker being heavily promoted by Big Pharma. At the rate they are going, these firms will soon be marketing a vaccine to prevent hangnails. Safe and effacious, my tuchus. Give it a couple of years and prepare for the lawsuits, ala Vioxx, another highly pushed moneymaker for the same company, Merck. With Vioxx yanked from the market for greatly increasing the risk of death from cardiac events, and lawsuits likely to run into the high millions, Merck badly needs the revenue stream, hence the rush to market Gardasil before the competition could introduce their own snakeoil preparation. You seriously think the bozos at the FDA got this one right? It's all about the Benjamins. Follow the money trail.

Posted by: Truth Teller | August 19, 2008 8:10 AM | Report abuse

I got the vaccine and had no pain or side effects of any kind ... seems to me that i should be better safe than sorry. my gyno said HPV is very very easy to get, and condoms don't prevent it at all, so there's not much you can do in general to avoid it if you are sexually active.

also i have friends who already had HPV who got the shots anyway, to help prevent possibly getting additional strains.

i'm well into adulthood, but as a child and now i always wondered why adults thought children were so unintelligent that they can't possibly understand that this shot (or condoms, or sex education) won't prevent 100% of diseases and pregnancy. as far as i'm aware, information and safety do not generally lead to promiscuity, even in children ... so why not be as safe as possible?

Posted by: ffx | August 19, 2008 8:11 AM | Report abuse

I know it looks like Big Medicine, but babies and little kids are the best chance we have to get people innoculated against pervasive illnesses that are easily spread. If it wasn't required by state law and school districts there would be a much lower percentage rate of innoculation against diseases that only recently killed a LOT of people in this country. Go back over the past 100 years and you'll be reminded of why we innoculate against TB, polio (at 52, I have peers who are living their lives with the after-effects of their polio), tetnus, influenza, small pox, hepatitis, pneumonia, etc. Many of these illnesses are no longer the threat they used to be in this country BECAUSE OF VACCINATION.
Yes, I had my 13 year-old vaccinated against HPV. Right now she's a very quiet, modest little girl. If she follows in her mother's footsteps, she'll have a quiet and happy little sex life with very few partners. But ONE partner could give her HPV. If I could have my son innoculated against HPV or a major cause of testicular cancer, etc. I would being in line with him, too.
HPV has very little to do with moral character and everything to do with epidemiology.

Posted by: Yo' Mama | August 19, 2008 8:21 AM | Report abuse

My gynecologist is very opposed to the vaccine and did not recommend at all.

Posted by: Arlington, VA | August 19, 2008 9:14 AM | Report abuse

Got my daughter vaccinated. The benefits seem to far outweigh the medical risks. And, this cancer is not easily treated if you miss it -- it can progress very quickly and is a painful death.

Posted by: Hebell | August 19, 2008 9:25 AM | Report abuse

My father's heart attacks were induced by the Vioxx he was prescribed, so I'm not a fan of Merck. Nor am I a fan of the government MANDATING Gardasil under the ridiculous argument that HPV is an infectious disease like mumps or chicken pox. Mandating the innnoculation of children against AIR-BORNE diseases is one thing, mandating innoculating them against sexually-transmitted viruses is quite another. That decision must be left solely to the parents, not politicians who are getting payoffs from Merck (yes, David Catania, I'm talking about you).

Posted by: WashingtonDame | August 19, 2008 9:30 AM | Report abuse


One thing I never see brought up: if you have a pap smear come back as abnormal, often caused by HPV, there are various things your gyno may do. They usually involve burning cells off your cervix, or procedures like a LEEP. Having had a LEEP or other procedures performed on your cervix can make you vulnerable to something called cervical incompetance in pregnancy. Many woman who have had these procedures either lose pregnancies around 17-20 weeks, or need to have their cervix's stiched with a cerclage...and are then on bedrest for the rest of their pregnancies.

Maybe this isn't a persuasive argument for getting your daughter vaccinated, but it's another part to consider. Cervical cancer caused by HPV may be rare, but abnormal pap smears aren't. Many women then have procedures like a LEEP done and this leaves their ability to carry a child vulnerable.

I'm glad my daughter is only one. Hopefully by the time she's 12-14 people will be less spooked by this vaccine and it's safety will be backed up by more years of use.

Posted by: Bethesda, MD | August 19, 2008 9:34 AM | Report abuse

This vaccine is a big oops waiting to happen. If I sold a vaccine that cured cancer but killed a third of the people on it, all I would have to do is pay the right people in the FDA hush money to roll it out as the new miracle cure. Yes, my example is harsh but let’s not dismiss the fact that the FDA has been wrong on many occasions about products they originally Ok’d. I say all of this to say that at the end of the day dont be fooled in to thinking that Merck (the same company that produced VIOXX) cares about young women. At the end of the day it is their legal duty to increase profits for their shareholders. Write me off if you want to but are you willing to risk your child’s health on a vaccine that we all know very little about besides what Merck tells us. Yes if there were more testing done and if this was 5 years from now who knows what time would tell. Meanwhile everyone’s in a rush to get their child vaccinated because they want to do right by their kids. Could you face yourself if the very vaccine you supported and rushed out to get ends up with horrible long-term effects. I will not be getting this vaccine because for me there is not enough evidence that it does what it’s supposed to. I will caution that everyone considering the vaccine read very carefully and if the vaccine is for your child I recommend that you sit down and talk about it. Make sure that there is a dialogue before the decision is made.

Posted by: MsTisa | August 19, 2008 9:46 AM | Report abuse

The CDC's webpage is not the place to go for information about the risks of vaccines. CDC works for big pharma now, so they have an interest in minimizing the appearance of risk in these vaccines. The agency picks and chooses what it wants to report to the public from the vaccine injury database. If you go to that database directly (which you can do), you will find many other very serious reactions to this vaccine, including complete, apparently irreversible, paralysis. And no, you should not expect a certain percentage of perfectly healthy young women to suddenly just drop dead for no reason. The women who died after receiving this vaccine died of complications from the vaccine. I am continually amazed at how gullible people can be -- just because the CDC says there's no link between a vaccine given one day and death the next day, you believe them. Incredible!

Posted by: clara | August 19, 2008 10:17 AM | Report abuse

I am a family doc who has administered many gardisil immunizations. From the medical literature we can infer they they do work very effectively to prevent cancer in STUDIED populations. This is a wonderful scientific achievement. The problem is that cervical cancer has become very rare in women who have access to medical care because of the effectiveness of PAP smear screening and treatment of abnormalities. (Of course in my mind prevention is always better than treatment.) The same group of gals who can get pap smears will get the gardisil shots. Thus it is highly likely that the same population of poor and uneducated women who do not have access to medical services and do not get pap smears will be the least likely to get their gardisil shots as well.They are and will remain at risk for the development of cervical cancer. Thus the USE EFFECTIVENESS of this vaccine in preventing cancer is likely to be disappointing. The answer to better health once again is not more medical breakthroughs, but a universal health care system.

Posted by: paradocsMD | August 19, 2008 10:32 AM | Report abuse

I am a family doc who has administered many gardisil immunizations. From the medical literature we can infer they they do work very effectively to prevent cancer in STUDIED populations. This is a wonderful scientific achievement. The problem is that cervical cancer has become very rare in women who have access to medical care because of the effectiveness of PAP smear screening and treatment of abnormalities. (Of course in my mind prevention is always better than treatment.) The same group of gals who can get pap smears will get the gardisil shots. Thus it is highly likely that the same population of poor and uneducated women who do not have access to medical services and do not get pap smears will be the least likely to get their gardisil shots as well.They are and will remain at risk for the development of cervical cancer. Thus the USE EFFECTIVENESS of this vaccine in preventing cancer is likely to be disappointing. The answer to better health once again is not more medical breakthroughs, but a universal health care system.

Posted by: paradocsMD | August 19, 2008 10:33 AM | Report abuse

I wish the vaccine had been available when I was younger. Perhaps then I would not have had to have a hysterectomy at age 29, made necessary by the HPV virus I received from my husband. As a result, I was not able to have another child, which I wanted very much.

Posted by: bajacalla | August 19, 2008 10:35 AM | Report abuse

I am still waiting for more information.
How often does a vaccine or drug get approved just to find that it doesn't work as well as they thought or is actually harmful to more people then they thought?
Measles vaccine came out in the 60's and 20 years later they find a booster is needed.
Chicken pox vaccine came out in the mid 90's and a decade later they find you need 2 shots for it to be effective. I didn't get my youngest vaccinated for chicken pox when it was first reccommended just because of the experience with the measles vaccine. I knew that there would be a change and figured I'd wait for it.
I fell the same way about Gardisil. Additionally since I keep hearing about younger girls having more side effects it doesn't seem like it would be appropiate for the preteen set.

Because they "experts' never seem to be sure the best way to do things I had both polio vaccines in the early 60's.

Posted by: Liz | August 19, 2008 10:48 AM | Report abuse

I have to say that I am very happy that my step-daughter is only 3. By the time she would get the vaccine, I am hopeful that they can figure out if it is safe or not.

I would not want to be making this decision about my children right now. I don't trust their tests. I used to take Vioxx for my arthritis and I can only say that I am greatly relieved that I did not have any side effects. I ended up going off of the drug on my own because the recommended dosage was simply not strong enough to resolve the pain. My doctor says that I shouldn't have any lingering side effects from taking the drug and I hope she is right.

Posted by: Billie | August 19, 2008 11:26 AM | Report abuse

paradocsMD, Gardasil is available almost free of charge to children who are Medicaid-eligible.

http://www.iht.com/articles/ap/2006/11/01/business/NA_FIN_US_Merck_Vaccine.php

Posted by: Tom T. | August 19, 2008 11:37 AM | Report abuse

To clara: Did you actually go to the VAERS (Vaccine Adverse Event Reporting System)? In 2007-2008 of the 8560 adverse events reported associated with Gardasil, 17 were deaths caused by:

Cardiopathy: 2
Thrombosis: 3
Arrhythmia: 3
Influenza sepsis: 1
Anaphylactic reaction: 1
Drugs: 1
Diabetic ketoacidosis: 1
Meningitis: 1
Unknown: 4

Only one case (anaphylactic reaction) was linked to the vaccine. And yes, you can expect a certain percent of woman to drop dead but they were not healthy (cardiac disease, diabetes, infections) nor they died for no reason (except the 4 "unknown" for lack of or inconclusive autopsy). There are also approx. 30 reports of paralysis, almost all resolved spontaneously after a few hours, so they were not irreversible. When are you and the superstitious anti-vaccine lobby you belong to, stop spreading lies?

Posted by: ogs | August 19, 2008 12:25 PM | Report abuse

I am a 26-year-old female and I know two women with HPV. These women are not promiscuous. They each slept with a man, while in a long-term committed relationship, and were infected. Educating young women about the dangers of unprotected sex and continuing routine pap smears are part of the solution. There’s nothing wrong with letting Gardasil be another defense against HPV.

Posted by: Arlington | August 19, 2008 12:35 PM | Report abuse

Having listened carefully to the ads and the info I've read this vaccine provides protection against "some" strains of HPV that have been known to cause cervical cancer. Doesn't sound like a true vaccine to me; more like a prophylactic. In spite of my experience with both of these, I am hesitant to vaccinate my daughters because of the huge (marketing and $$) push by Merck to force this on the widest possible population. It makes the vaccine suspect. I doubt I will have my 9 y.o. vaccinated for another 5+ years so that I can see where the chips fall.

Posted by: flabbergast | August 19, 2008 12:39 PM | Report abuse

Interesting Discussion. I think it's great that we have the option of the vaccine but am totally opposed to the government mandating it. Before the vaccine became available, Merck was recommending boosters after 5 years because of decreased effectiveness. So those who are vaccinating 9, 10, or even 13 year olds, will most likely need to give their little ones a booster when they're more likely to be sexually active. Listen, we don't know what goes into vaccines (mercury was used as a preservative in the first vaccines our children received as recently as 10 years ago and is still being used in flu shots today). For those choosing to vaccinate their daughters - why the rush? Why give a 9 year old a boost of chemicals on the chance that in 5-8 years she'll become sexually active? Wait until you both can make an informed decision on the matter. For those who are old enough to know that they're going to have unprotected sex then yes, this is another tool in your toolbox of protection, but for sure there are many, many other STDs (including AIDS) that you are still susceptible to. Finally, isn't it interesting that Merck created this for women and girls? If the males are the carriers then why didn't they develop the vaccine for the males?

Posted by: PB | August 19, 2008 1:06 PM | Report abuse

To Ogs:

Just because the VAERS says the person died of cardiac arrest, you assume it had nothing to do with the vaccine. Boy, the pharm. industry counts on people to be as stupid as you. Aren't they lucky there are so many of you.

And the cases of paralysis do NOT all resolve after a few hours. There are now numerous cases of complete paralysis -- one that happened in April of this year to a young girl -- that months later have not resolved. (She is still completely paralyzed.)

Posted by: clara | August 19, 2008 1:08 PM | Report abuse

From "smart" clara:
"Just because the VAERS says the person died of cardiac arrest, you assume it had nothing to do with the vaccine. Boy, the pharm. industry counts on people to be as stupid as you. Aren't they lucky there are so many of you."

If you would bother to read the full description of each case, you would notice that all the ones that died from cardiac troubles had a history of cardiac disease.
The vaccine might have something to do with those cases or not, there is no way to know. If you know anything about reporting adverse events, you should know that anything that happens medically to someone after he/she takes a drug/vaccine must be reported in association with that drug/vaccine, even hearsay. There is often no further investigation and even if there was, there is no way to find out if it was a cause/effect relationship without a carefully designed clinical trial.

Posted by: ogs | August 19, 2008 2:50 PM | Report abuse

To Ogs:

First of all, if you know anything about VAERS you know that the adverse events reported to VAERS represented but a small fraction of all the adverse events that actually occur. Doctors are supposed to report all such events, but it is an entirely voluntary system, and many do not comply. (Government officials openly acknowledge this fact.) What is even more frightening, however, is that sometimes even when docs try to report an adverse event, they are unable to get through to anyone. For example, one doctor tried to report to VAERS after a newborn baby died following a Hep B vaccine (a totally non-sensical vaccine to give newborn babies, by the way). The doctor repeatedly got voicemail, and no one ever called him back! So the system, as it is, represents only a tiny fraction of the whole. Still, there are many adverse events reported, and it is usually more than a coincidence when someone with an underlying medical condition, such as heart trouble, dies a short period after receiving a vaccine. This is precisely why the original advocates of innoculation always emphasized two things: 1) That the threat from the disease must be imminent; and 2) That it mustbe serious, i.e. big risk of life-long disability or death. They knew that vaccines could never be made entirely safe. If the threat of serious disease is not serious and imminent (e.g. Hep B, chicken pox, mumps, to name a few), and there are other, safer ways to greatly reduce the risk of the disease (e.g. cervical cancer), then humans should not be vaccinated. But because government-mandated vaccines now make drug companies so filthy rich, these basic principles, which were the connerstone of the U.S. vaccination program in previous generations, have been thrown out the windown.

Posted by: clara | August 19, 2008 3:56 PM | Report abuse

PB had it right. MEN are the carriers. If the government wants to mandate anything, it should be to vaccinate all men and boys before they start school. Men are the problem here, women are the sufferers. So follow the problem to the source and SOLVE THE PROBLEM; don't just treat the outcome. More women need to be in positions of power in these companies so idiotic decisions like this aren't presented like a miracle band aid to what women suffer through the promiscuity of MEN.

Posted by: dmt2 | August 20, 2008 4:17 PM | Report abuse

More news this morning on Gardasil. See http://abcnews.go.com/search?searchtext=gardisil&type=
on ABC News.
According to The New England Journal of Medicine Editorial - Does Gardasil Really Prevent Cancer? The Journal does say it will kill the bacteria..... BUT???
Seems to be a BIG But?? Prevents the infection of 2 of the virus strains.
I will hold on the decision whether my daughter should have the shot. She is 12 and unfortunately the information that will confirm that the drug does kill the cancer will not be known before I need to make the decision!!!!

Posted by: Karen | August 21, 2008 9:57 AM | Report abuse

Anyone considering Gardasil should read this from the vaccine info center http://www.909shot.com/PRESSRELEASES/pr62706gardasil.htm

Gardasil has not been proven safe. Girls who receive it are the guinea pigs in Merck's trial now. All for their own profit.

Posted by: concerned | August 21, 2008 11:39 AM | Report abuse

fr KL_VA:

>...Regular PAP smears and advising my daughter on the dangers of promiscuity, along with the need for safe sex will have to suffice as her protection against the disease....

Um, you've heard of RAPE, haven't you?????

Posted by: Alex | August 22, 2008 10:13 AM | Report abuse

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