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Gardasil: Do the benefits of the HPV vaccine outweigh the risks?

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The controversy surrounding the Gardasil vaccine has been around from the moment it was approved for use in young girls. And from the very beginning I have had a problem with Gardasil being referred to as a cervical cancer vaccine - because it's not. I also have a problem with the 'fear mongering' commercials designed to look like public service announcements, and the possibility of making this vaccine (yet another) required by the government.

In the end, I want to research the facts and be the one to make an educated decision about whether or not to vaccinate my daughter for the HPV virus. To be perfectly honest...At this point I don't see any indication that the benefits of this vaccine outweigh the risks. Although the risks are very small, the benefits seem to be even smaller.

But don't take my word for it...Look at some of the most recent facts about Gardasil.

From The New York Times - Study Weighs Risks of Vaccine For Cervical Cancer...

“There are not a huge number of side effects here, that’s fairly certain,” said the editorial writer, Dr. Charlotte Haug, an infectious disease expert from Norway, about the vaccine. “But you are giving this to perfectly healthy young girls, so even a rare thing may be too much of a risk.

“I wouldn’t accept much risk of side effects at all in an 11-year-old girl, because if she gets screened when she’s older, she’ll never get cervical cancer,” Dr. Haug said in an interview. “You don’t have to die from cervical cancer if you have access to health care.”

This is the point I have been trying to make from the beginning of the world-wind push to insist every girl get this vaccine in order to be "one less" person to get cervical cancer.

The FDA and CDC are still claiming that the benefits outweigh the risks of this vaccine. But there is a lot of information for parents to look at before they make the decision to have their child vaccinated.

To start with...When you break the numbers down in this article, it basically says that the small number of "severe" adverse reactions are within acceptable limits...

That was calculated as a rate of 53.9 adverse event reports to the Vaccine Adverse Event Reporting System for every 100,000 doses of vaccine distributed.
. . .
Of the total number of reports, 6.2 percent, or 772 reports, were considered serious events, including 32 reports of death.

As of June 1, 2009, more than 25 million doses of Gardasil were distributed in the United States. So by the looks of it, 6.2 severe adverse reactions for every 100,000 doses is clearly a very low number. And if this vaccine can save lives by preventing a deadly disease like cervical cancer, the benefits must surely outweigh the risks. Right?

But before you can determine whether the risks of the vaccine are acceptable, we need to take a look at the actual risks of cervical cancer.

This is from the CDC website - Cervical cancer rates in the United States...

For every 100,000 women in the United States - between 3.5 and 12.8 women will develop cervical cancer (that's about 4-13 women for every 100,000 women, depending on what state you live in). And because we have such effective treatment for cervical cancer in the United States, only between 1.6 and 3.7 women in 100,000 will die from cervical cancer.

So...The risk of death from cervical cancer is even less than the incidence of severe adverse reactions to the vaccine. These numbers seem to indicate that the benefit of not getting cervical cancer is even less than the risk of severe adverse reactions to the vaccine.

To help put the numbers into perspective...

Compare that to breast cancer where 123.8 women for every 100,000 will develop breast cancer and 24.5 of 100,000 will die from it.

And compare that to the 1 of every 2.5 women who will die of heart disease (the leading cause of death for women).

From The LA Times - Is HPV Vaccine Worth It?

Taking into account both articles is a related editorial. It states: "Whether a risk is worth taking depends not only on the absolute risk, but on the relationship between the potential risk and the potential benefit. If the potential benefits are substantial, most individuals would be willing to accept the risks. But the net benefit of the HPV vaccine to a woman is uncertain. Even if persistently infected with HPV, a

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Lilyv 5 pts

I have been reading your articles on Gardasil and the negative effects it has had. The last article I could find was in 2009, have you written anything since then.

I am not keen on seeing this drug given to my grandchildren, but there does not seem to be any recent articles in the on the internet, everything seems to be mainly in 2007 a year after the drug came out, and a few up to 2009.

I live in New Zealand and it was introduced in 2008 and I have not found any adverse reports on it over here.

I did read on a site in New Zealand that since PAP smears were introduced the incidence of invasive cervical cancer has dropped 40%, however it also mentioned this was a significant health cost, so I'm wondering if the vaccine is cheaper for the government so that is why the governments are pushing it.

What is your opinion on this and where do you think people are at in U.S.A. now in 2011.

spdy69 5 pts

First of all, I applaud you for looking up facts on Wikipedia about Hepatitis B. I think if anyone on this post wants to be really educated, they will properly research the topic using peer reviewed journals. First of all, HPV has no cure - and yes, many times it does clear spontaneously, but many times the virus remains latent for years before it is "reactivated" later on in life. Pap smears can only tell if you have cervical dysplasia and cervical dysplasia only occurs when the HPV has been "activated." Most women carry the inactivated form of HPV and after 30 years of age, the risk of it "activating" increases exponentially. This is why the majority of cervical cancer cases occur in older women (because HPV is more likely to activate at this time).  Secondly, you say that the incidence of cervical cancer is just "a blip"  compared to the 20 million Americans that carry the HPV virus. Well did you know that cervical cancer is the second leading cause of cancer deaths WORLDWIDE? In 2008, a study by Watson et al assessed the burden of HPV-associated cancers in the U.S. during 1998 through 2003 using cancer registry data. The study estimated that an average of 10,800 new cases of cervical cancer are diagnosed each year in the U.S. along with 2300 cases of vulvar cancers, 800 cases of penile cancers, 600 cases of vaginal cancers, 3000 cases of anal cancers, and 7400 cases of head and neck cancers, all of which were associated with HPV. Actual morbidity and mortality for cervical cancer alone in 2005 revealed 11,999 diagnoses of cervical cancer and 3,925 deaths as a result of the disease.

Also, in 2007, the U.S. National Health and Nutrition Examination Survey concluded that women between the ages of 20 and 24 (44.8%) had the highest prevalence of HPV infection. During that same year, the CDC reported that of those infected with HPV approximately 23% of cases were caused by high risk (HR) types. Furthermore, HR types were found to be strongly associated with younger populations, accounting for 64% of women between the ages of 14 and 29. Individuals that contract HR types were also more likely to be infected specifically with types 16 and 18 (the two types that cause more than 90% of cervical cancer cases), affecting 26% of women between the ages of 14 and 29.

Also, transmission is not solely due to sexual intercourse. This is the most common however many many studies have shown reservoirs for the virus on the penis shaft, scrotum, anus, cervix, vagina, vulva, urine, and hands...This means that non-penetration sexual activity including "casual contact" - or oral-genital or hand-genital contact can transmit the virus....So yes folks, your 11 and 12 year olds who are touching other kids (and not having sex) CAN get the virus!!! And guess what??? There have been tons of studies looking at the percentage of CHILDREN who have HPV - and not just HPV, but the high risk types that can lead to a number of different cancers (not just cervical).

I personally think it's a no-brainer that children should get the HPV vaccine. I'm not necessarily a proponent for the vaccine being REQUIRED, as I think everyone should have the choice as to whether or not they want their child to be vaccinated ...but I I think it's crazy that anyone would say no to an anti-cancer vaccine.

And yes, we don't know long term effects of the vaccine --- but as of now it has shown 100% efficacy in preventing cervical cancer from the two most common types of HPV --- and no serious adverse effects have been directly linked to the HPV vaccine.

If I had a daughter, she would be getting this vaccine, no doubt.

sebeaver 5 pts

I find myself also struggling to make a real decision on whether the risks out weight the benefits of Gardasil. My initial thoughts were pro this vaccine because anything that prevents cancer should be a good thing, right? Well looking at the statistics of the drug, it seems like the adverse risks of this drug are pretty low, however, may seem higher than the risk of cervical cancer itself? That kind of turned me away and made me think that it might actually be in girls best interest not to get the vaccine. However, with any type of medicine, there always are health risks, and HVP doesn't always lead to cervical cancer if regularly screened. So for me, it comes down to the decision of the parent or the girl. If they feel by getting this vaccine is right for them then I say do it. I think be informed about the vaccine and knowing the risks will help some one determine if that is a risk they want to take. I think making this vaccine mandatory is a little ridiculous because I honestly didn't think cervical cancer was that big or a concern compared to something like breast cancer. 

I did hear something interesting on this topic today, Gardasil (or a vaccine like it) in a few years will be available for young men between the ages 9-26. It is my understanding that men are the carriers for HVP, so by making this vaccine available to men, would it be more effective at eliminating cervical cancer for women? 

-Shannon Beaver

Catherine Morgan 5 pts

Thanks for sharing your story, I am very sorry to hear about your daughter.  I've always wondered how many adverse reactions were actually reported to VAERS, considering so many people have never even heard of it.

Contributing Editor Catherine Morgan

at Catherine-Morgan.com ( http://catherine-morgan.com/ ) and Women4Hope ( http://women4hope.wordpress.com/ )

rdmathis2 5 pts

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.

Leighbra 5 pts

I've actually been losing sleep over this issue recently, because my daughter is 11, and due for a doctor's appt for a booster to her DTaP series, and I know that this will be brought up.

The thing that most gives me pause is that we don't have any real indicator about this vaccine needing boosters or not. If the vaccine lasts 6-7 years, and these girls are getting it at 11, they may be unprotected (but still think they're covered) as they head off to college.

I'm a big supporter of immunizations, and don't think that this vaccine will magically turn my 11 year old into a promiscuous wanton tween, but I'm not fond of experimenting on my kids. I figure if she does need the shot later on, when we're talking about birth control will be a more appropriate time for her to get it.

I spent a considerable amount of time talking to the rep at the Pearl of Wisdom booth at BlogHer 09, it would be interesting for one of them to reply to this post.

dufmanno 5 pts

I'm struggling with this decision as I sit here with the kids medical forms. The school sent information letting us know we can opt out of this vaccination with no consequences so I think that's the route I'm going to take. Frightening the number of required shots you need these days to even send them into a classroom.

TW 6 pts

 Because they do it at the hospital before they leave or did at that time. He was my first child and I was exceptionally well read and obsessively read all the hospital maternity info and they never mentioned it. Silver nitrate, I was ready for. Hep B no.

~TW ( http://ramblewoman.blogspot.com )
( http://retro-food.com/ )

Retro-Food ( http://retro-food.com/ )

( http://retro-food.com/ )

Catherine Morgan 5 pts

Hi TW.  The Hepatitis B Vaccine is much more important than Gardasil.  Here are some facts about Hepatitis B...

Hepatitis B can be fatal.
Hepatitis B, once caught, has no cure. There is, however, safe and proven prevention in the form of the hepatitis B vaccine.
Hepatitis
B virus infects over 200,000 people in the US every year, and there are
currently 1.5 million chronic carriers in America alone.
Hepatitis
B kills over 5,000 Americans each year. It is a leading cause of
chronic cirrhosis and a known cause of hepatocellular carcinoma. Death
is usually delayed 10 to 20 years from the time of original infection.
The
hepatitis B virus is found in blood and body fluids such as semen,
vaginal secretions and breast milk. It can be spread through sexual
contact; by sharing needles or razors; and by tattooing or body
piercing with unsterile equipment. However, 40% of those infected do
not know how they contracted the disease and acknowledge no risk
factors when asked.
Pregnant women with hepatitis B
will infect more than 50% of their infants. 90% of the 6,000 infants
infected perinatally in the US each year will become chronic hepatitis
B carriers, and 25% will eventually die of cirrhosis or liver cancer.
Up
to 30% of all pediatric infections occur through contact with adult
chronic carriers of hepatitis B living in the same household.
Once you have Hepatitis B, you have it.  It will not go away on it's own and it can not be cured with any medication. On the other hand, the majority of HPV infections will clear up on their own without treatment, and when needed there are effective treatments.  It is very, very rare for HPV to cause cervical cancer.  Think about it this way - About 50% of all men and women will have an HPV virus at some point in their lives (that's huge numbers 20-30 million just in the US). But the incidence of cervical cancer in comparison to those numbers is barely a blip. There is just no comparison of the importance of the Hep B vaccine and the HPV vaccine, it's comparing apples to oranges.

Thanks for your comment TW.

Contributing Editor Catherine Morgan
at Catherine-Morgan.com ( http://catherine-morgan.com/ ) and Women4Hope ( http://women4hope.wordpress.com/ )

confusedhomemaker 5 pts

The press jumped on the idea fed to them via companies who seemed to implying that objecting or having concerns about this drug was simply a stance a only an extreme religious loon who was obsessed with sex would take. And people jumped at the bait, making it about an ancillary issue versus the real health effects of this vaccine on women's health (including the health of minor females).

When the concerns about possible sexual behavior weren't the reason most people I know or read writing concerns about this vaccine, instead it was the overall efficacy and long term benefits to administering this drug to females of all ages.  I'm apt to argue that it was a red herring all along to push the real objections based on science off to the side while focusing on a supposed belief that having this vaccine would increase sexual behavior by religious persons. Talking about that issue distracted people from the real issue which related to the actual need & effect of this vaccine on female health. 

beth aka confusedhomemaker

http://theconfusedhomemaker.com/ ( http://theconfusedhomemaker.com/ )

TW 6 pts

 My son was an hour old when I was asked to sign the Hep B vaccine consent...using very much the same reasons that HPV vaccination is recommended. 

~TW ( http://ramblewoman.blogspot.com )
( http://retro-food.com/ )

Retro-Food ( http://retro-food.com/ )

( http://retro-food.com/ )

Suzanne 5 pts

I'm neither religious, conservative, or against vaccines in general, but there's just something about the way this was pushed and advertised that really, really bothers me. Again, HPV is not something you just catch. People can protect against it without having a foreign substance injected into their systems. I just don't trust the drug industry any more. A friend of mine who ran stats for a drug manufacturer told me some horror stories about how they pervert their safety tests.

Suzanne Reisman ( http://www.blogher.com/member/suzanne-reisman ), Contributing Editor - Feminism & Gender ( http://blogher.org/topic/feminism-gender )
Campaign for Unshaved Snatch (CUSS) & Other Rants ( http://cussandotherrants.com/ )

Suzanne 5 pts

Damn, that makes me depressed.

Suzanne Reisman ( http://www.blogher.com/member/suzanne-reisman ), Contributing Editor - Feminism & Gender ( http://blogher.org/topic/feminism-gender )
Campaign for Unshaved Snatch (CUSS) & Other Rants ( http://cussandotherrants.com/ )

Catherine Morgan 5 pts

Hi Mir.  I think you made the right call with your daughter, time will continue reveal the risks and benefits of this vaccine.  If you do decide to have your daughter vaccinated, at least you will have had the opportunity to make an educated decision about it.

I think it says a lot about the benefits/risks of Gardasil when doctors are beginning to let it slide when parents are refusing this vaccine. 

Thanks for commenting.

:-)

Contributing Editor Catherine Morgan
at Catherine-Morgan.com ( http://catherine-morgan.com/ ) and Women4Hope ( http://women4hope.wordpress.com/ )

Catherine Morgan 5 pts

Hi Suzanne.  I totally agree.  The sad thing is...they have probably already estimated the costs of future lawsuits, and still know they will be making huge profits. 

Contributing Editor Catherine Morgan
at Catherine-Morgan.com ( http://catherine-morgan.com/ ) and Women4Hope ( http://women4hope.wordpress.com/ )

Mir Kamin 6 pts

You know, when we first started writing about Gardasil here at BlogHer, I really believed that all of the anti-vaccine hype came from the religious/conservative camp, eager to equate the vaccine with a green light for promiscuity.

But the more I read about it, the more I feel like I really didn't take in the whole picture, initially. My daughter's ped tried to talk me into the vaccine for her this summer and I declined. I'm not saying she'll never get it, but right now, I can't justify it.

Thanks for staying on top of this issue, Catherine. I'm getting a great education.

--
Mir Kamin
(BlogHer contributing editor)

Personal: Woulda Coulda Shoulda ( http://wouldashoulda.com/ )

Having it all with less: Want Not ( http://wantnot.net/ )

LucindaA 5 pts

I read about the push to require it and I was outraged.  This is one vaccine I would opt out of because I just don't see the benefit outweighing the risk.  I think you are spot on.

Suzanne 5 pts

Given the very poor track record of drug companies , biased tests, and medical safety, it scared me how hard Gardasil was being pushed. HPV is a preventable disease, and everything else you said about how it is not a drug for cervical cancer. This isn't like MMR, which I fully support. This is a scare tactic for a drug company to make a lot of money very quickly, consequences be damned. In a few years, I wonder how much of the short-term profit will go to paying out lawsuits.

Suzanne Reisman ( http://www.blogher.com/member/suzanne-reisman ), Contributing Editor - Feminism & Gender ( http://blogher.org/topic/feminism-gender )
Campaign for Unshaved Snatch (CUSS) & Other Rants ( http://cussandotherrants.com/ )

Suzanne 5 pts

Wow, that's intense. I guess I'd say the only difference between the two is that you can get Hep B from a blood transfusion, and I don't think you can get HPV that way. Still, only an hour old? Just wow.

Suzanne Reisman ( http://www.blogher.com/member/suzanne-reisman ), Contributing Editor - Feminism & Gender ( http://blogher.org/topic/feminism-gender )
Campaign for Unshaved Snatch (CUSS) & Other Rants ( http://cussandotherrants.com/ )