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Gardasil: Do the Risks Outweigh the Benefits?

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Over 24 million doses have been distributed in the U.S. But how safe is it? Momlogic investigates.

Girl getting vaccine

We've all seen the "One Less" commercials promoting Gardasil, the cervical cancer vaccine that helps protect against 4 types of human papillomavirus (HPV). This three-dose vaccine, which was introduced in 2006, is for girls age 9 to 26. Over 24 million doses have been distributed in the U.S.

The momlogic office has been flooded with letters and e-mails from mothers grappling over whether to vaccinate their tweens and teens or not. Some wonder if their kids even need it, since they're not sexually active. ("Will giving my daughter these shots be like giving her a license to have sex?") Others are concerned about the side effects. As of May 1, 2009, more than 24 million doses of Gardasil have been distributed in the United States. There have been 13,758 Vaccine Adverse Event Reporting System (VAERS) reports following vaccination. Ninety-three percent were reports of events considered to be non-serious, like fainting, headache, or fever. But seven percent were considered to be serious -- such as hospitalization, or even death. Yes, death. Thirty-nine women have died after getting the Gardasil vaccine, according to the CDC. To date, none of these deaths has been officially linked directly to the vaccine.

Guillain-Barré Syndrome (GBS), a rare disorder that causes muscle weakness, has been reported to have occurred after vaccination with Gardasil. Barbara Mellers' 15-year-old daughter, Jenny, passed away in March 2009 from what doctors suspect was autoimmune in causation. She started developing muscle weakness shortly after getting her third Gardasil shot in March 2007. "In May 2007, Jenny came home from school one day having tripped over a hurdle in P.E. class. It was 1 and a half feet high. All the other kids cleared it easily," Barbara recalls. By December, Jenny had to use a walker at school, and her muscle weakness was getting progressively worse. No one knew what was wrong with her, and she was sent to countless specialists. By summer 2008, Jenny was a quadriplegic who could breathe only with machine support. "We had wonderful friends helping us look for other children who were similar to Jenny," Barbara says. "We set up a website. We reached out to doctors all over the world to find treatments, experimental drugs, and medications. We tried so many things. Sometimes we thought she was getting better. Maybe the disease was slowing down or even reversing. Then she'd get a little worse, and we knew we were wrong." Despite everyone's Herculean efforts, Jenny died in pediatric ICU on March 15th, 2009. To read more of Jenny's story, click here.

Was Gardasil to blame for Jenny's death? That has yet to be determined. Her family hesitates to declare that Gardasil was the cause of her death, but some prominent medical scientists at leading universities see the connection as possible and even plausible. Jenny's parents, both college professors, would like to persuade the Centers for Disease Control (CDC) to investigate how many Jennys are out there.

Is Gardasil safe for YOUR daughter? We asked two well-respected OB/GYNs, Dr. Hilda Hutcherson and Dr. Suzanne Gilberg-Lenz, to weigh in on this serious issue.

ML: Is Gardasil a must for all teen girls, even if they are not sexually active?

Dr. Hilda: Many people tie this vaccine to sexual activity, but we need to separate it from sexual activity and look at it as cancer prevention. When you look at it as cancer prevention, it's a lot easier to embrace it. I tell moms that you are giving something to your daughter that could potentially save her life in the future.

Dr. Suzanne: I try to explain to moms, in plain English, what HPV is and why it poses problems -- i.e., what the virus is, what the subtypes are, and which are the "bad players." I tell them that Gardasil may reduce the risk of transmission of four specific subtypes of the virus that can cause genital warts and that can cause dysplasia, or potentially pre-cancerous changes of the cervix that may lead to cervical cancer if left untreated in some, not all, women.

Moms should ask themselves: Are they getting their daughters vaccinated with a clear understanding of what the vaccination can and cannot do, or are they doing it out of panic, fear, or guilt?

With all due respect, no one ever knows for sure what another is really up to, and even the best mother-daughter relationships might harbor some secrets. Furthermore, assuming that the non-sexual teen will reliably remain in that state is just an accident waiting to happen. I say give your daughters (and sons!) all the best info and resources, and guide them to trusted grown-ups (counselors, doctors, etc.) ahead of time, if at all possible, so that they do have someone who is not you to talk to just in case. My teen patients who are given these opportunities may feel embarrassed initially (the "mooo-om" syndrome), but also appreciate the respect that their parents are giving them to make decisions safely and wisely.

ML: Many mothers who write to us with hesitancy about the vaccine fear they are hurting their daughters by NOT allowing her the vaccine. Are they?

Dr. Hilda: I don't believe in making mothers feel guilty. I just try to provide the information. I say, "These are the facts we have right now. You use the information given to you and make the best decision based upon this." You as a mom have to make the right decision for your child.

Dr. Suzanne: It is true that rates of STDs among teens are on the rise. According to a 2006 Kaiser Family Foundation report, 25% of 15- to 19-year-olds and nearly 50% of American teens have had chlamydia, trichomoniasis, or HPV, with HPV being most common. 35% of 13- to 19-year-olds are HPV-positive. But it is also true that 80-90% of those infected, even with the highest-risk HPV strains, will clear the infection on their own within two years. In the end, it is a crap shoot!

ML: What about uninsured girls whose parents can't afford the pricey protection?

Dr. Hilda: The people who need it the most aren't getting it. It's an access issue. They don't have access to something that could be life-saving, because they can't afford it. I feel it's something we should provide for women who can't afford it. Children age 18 and younger may be eligible to get vaccines, including the HPV vaccine, for free through the Vaccines for Children program.

Dr. Suzanne: I believe that leveling the field was one of the aims of the bills that some states proposed to require vaccinations for school entry, similar to other more common vaccinations such as measles, hepatitis B, etc. It's also important to note here that 85% of diagnoses and deaths due to cervical cancer occur in developing nations. Clearly, poverty and lack of health care play a big role in this disease and need attention. We should be getting this vaccination to the poor women of the world regardless of their country or residence.

ML: It's a brand-new drug -- why are we lining up our daughters to get these injections without more thought?

Dr. Hilda: The FDA doesn't let anything get through unless it was adequately tested, and I think this vaccine was properly tested. I feel comfortable recommending this vaccine to my family members. There's nothing on this planet that doesn't have risks, but you have to weigh the benefits and the risks.

When you measure the few women who possibly had a bad outcome (that we can't yet directly link to the vaccine) and the thousands of women whose lives can be saved, I come out on the side of the benefits outweighing the risks.

Dr. Suzanne: Why are we lining up our daughters to get these injections? Because as moms, we want to do the right thing, and we got the message loud and clear that this was the right thing.

ML: How do we know the long-term side effects when the drug was so quickly approved and administered in waves?

Dr. Hilda: There are reported short-term side effects and reactions like fainting, but I haven't seen that in my office. In terms of the long-term side effects, the FDA has approved this and deemed it safe. I don't think it was "quickly" approved because they don't "quickly" approve anything! Gardasil was thoroughly tested before it came on the market. And if it protects you from cervical cancer and can potentially save your life, that beneficial effect cannot be disputed and in my opinion, outweighs the risks.

Dr. Suzanne: The FDA approval process involved more than 4,000 vaccinations over 4 years, and this government body felt that this was adequate to bring the product to market. Understanding that there had been no way, prior to this point in time, to prevent the disease -- and the public health and personal impacts of not only cervical cancer, but frequent pap smears, colposcopies, cervical biopsies, the physical and psychological pain, shame, and blame -- is really critical in adding context to the decision to develop the vaccination and bring it to market rapidly. There has been long-term frustration in this area for patients, researchers, and practitioners.

A handful of my patients developed side effects. One developed mysterious neurological symptoms that we cannot diagnose. There is no way to know if this is a coincidence or not, but more than one study, including a 2007 study looking at 270,000 doses administered in Australia, has revealed a five- to ten-fold increase in "reactions" to this vaccination over other common vaccinations. The absolute numbers are quite low -- 7 incidents in 270,000 -- but statistically significant.

ML: What about the reported deaths?

Dr. Hilda: These cannot be directly tied to this vaccine. Millions have received the vaccine, and 39 young people tragically died at some point after receiving the vaccine. Those deaths have not been tied directly to the vaccine at this point. I feel for the families, and no young person should have to die, but this vaccine will save thousands of lives per year.

Dr. Suzanne: It has been very hard to link the reported incidents, reactions, and deaths to the vaccination, partly because there is no obvious pattern and the absolute numbers are low. But for most mothers, they are obviously a cause for concern.

ML: Would you allow your daughter to get the Gardasil vaccine?

Dr. Hilda: Yes.

Dr. Suzanne. She is only 8. The jury is out.

How do you determine whether the benefits outweigh the risks for your daughter? Both doctors agree that this isn't a decision that should be taken lightly. Download momlogic's Should Your Daughter Get the Gardasil Vaccine? Questions Every Mother Should Ask printable guide for more guidance.

Is the Gardasil vaccine safe for your daughter? Momlogic's OB/GYN Dr. Suzanne Gilberg-Lenz went on NBC's "Today" show this morning to shed more light on the subject.


Would you allow (or have you allowed) your daughter to get the Gardasil vaccine? Why or why not?




next: 'Cash for Clunkers' Program Runs Out of Gas
43 comments so far | Post a comment now
Gigohead  July 30, 2009, 10:11 AM

I’m not rushing just yet to get my 9 year-old vaccinated. I’ll wait until the verdict is officially out on these which won’t be in a few more years. I’d like to see the 5 and 10 year history of this vaccine. If my daughter gets it by 19 than that’s fine too. I do hope this works. I don’t want her to ever get cervical cancer, but I also do want her to be safe. Waiting right now is the logical choice for me.

No Way July 30, 2009, 10:11 AM

I’m 24 and my doctor recommended that I get the Gardasil vaccine. I’d heard about it and just trusted her word and the info she gave me. After 1 shot I was sick for 3 weeks. Nonstop headaches, nausea, delayed period (didn’t get it for 2 months).

I decided not to get the 2nd and 3rd injections. I have a daughter who isn’t yet old enough for this, but once she is I will NOT be giving it to her.

Nina July 30, 2009, 2:33 PM

The HPV Vaccine has to be one of the murkiest medical topics in recent history. For parents who dutifully vaccinated their children, a cancer-preventing vaccine is a dream come true. But what is it about HPV and/or Cervical Cancer that we need a vaccine and, in some states, make it mandatory? What increases in HPV related illness and cervical cancer have the medical community been seeing to so strongly support vaccination? To me, these questions are unanswered and from where I sit, the cart is before the horse. I’d rather a doctor discuss healthy lifestyle habits (diet, exercise, not smoking, annual physicals) and the HPV Pap Test, than to recommend a vaccine to girls as young as 9.

Anonymous July 30, 2009, 3:39 PM

Women are freaking out about this just like they did with Norplant.

ame i. July 30, 2009, 5:13 PM

I’m just not sure yet. My daughters are 11 and 9 so I have time to wait and see what other reports come through before deciding.
I married young with no sexual experience besides my husband, same with him. He died in 2003.
My “now” husband of almost 2 years agreed to visit his doctor for STD testing before we were intimate. I had no reason to but did also.

Kirstie July 30, 2009, 5:53 PM

The large number of potential reactions really worried me, so I chose not to get the vaccine when I was offered it - at the same time I got the vaccine for meningitis, which was required to live in a dorm. I’m definitely pro-vaccine, but I’d choose to wait to learn more about this one if I was thinking about getting it. Girls have suffered paralysis, coma, severe swelling, etc - it’s pretty scary.

I know I won’t ever bother getting Gardasil, as I’ve only ever been with one person, who was also a virgin when we got together. Since we’re planning to get married … I think I’ll be okay on HPV. =]

Rosemary Mathis July 30, 2009, 6:27 PM

My 13 year daughter missed almost the entire school year last year because of the Gardasil vaccine. Because of Gardasil, she was one less child, one less student, and possibly could have been one less daughter. She was vaccine injured and is being treated by Wake Forest Medical Center and Duke University Children’s hospital. She was given this vaccine by her pediatrician who highly recommended it. Within 2 weeks after taking the last dose, she was taken down almost completely. She went from being well with no previous illnesses to being sick 97% of the time. She was in this state for around 5 months. The worst part is that doctors do not understand vaccine injuries and when they occur and the injured are pretty much on their own to research and treat the symptoms. The vaccine injury has caused my child to struggle for a year and least important, has also cost thousands of dollars in medical expenses. In my opinion, the benefits do not outweigh the risks and I do not want my daughter to be one less because of this vaccine. Parent should investigate before you vaccinate because there are a lot of sick girls out there who would agree, it is not worth it. The CDC and FDA need to investigate the side effects of vaccines, because basically, the public is own their own in this fight. Our government is not doing their job in this area.

Gloria  July 30, 2009, 7:19 PM

“The people who need it the most aren’t getting it. It’s an access issue. “tsh tsh Dr. Hilda, do you have preconceived notions about the poor people being more promiscuous than the rich?

Facts indicate that more white people, rich or poor, rank highest in the grouping of the more than 24 million juveniles with HPVs in this country’s population.

My rich friends growing up were more prone to pregnancy in 6th grade than the lower income friends.

Socioeconomics has nothing to do with priorities or values or supervision.

I WILL tell you that jobs and socializing do keep parents from supervising their children/juveniles.

I am also surprised to hear that you ALL still think that:
1. HPVs cause cancer, cervical or otherwise
2. that there aren’t other solutions for cervical cancer less hazardous, like natural progesterone creams and essential oils
3. that everyone has to have pre-marital sex, thus STDs
4. and that gardasil isn’t causing effects in those who think they don’t have phenotypical signs of a reaction.

With no lab tests on animals to significantly TEST the magnitude of how the vaccine alters the organs, blood or other systems in the body there is simply NO WAY to know what is actually happening in the body after the vaccine is given.

In vitro is a poor substitute for a living body with diverse organs (heart) and other systems that function in unison or not at all.

Animals need to be tested so scientists can observe the organs and blood and what happens to them as far as catalyst toxins are concerned. The girls are getting poisoned.

It is simply an experiment and VAERs is simply the collection of results.

Results that should have been collected from lab animals before subjecting it to humans.

1 death is too many, 32 is outrageous and 76 is over the top.

How can these VAERs results even be monitored correctly, from being tampered with?

Moms have complained that the results are incorrect and there is no way to get the site to correct the logged posts.

Because no lab tests were conducted, no medical community can correctly and assuredly recognize the failed cases or even treat them; something that they should be doing for free as well as compensate the families of the grieving.

The victims are off alone wondering how to save their girls from resulting in death. Not a pretty picture!

Lindy July 30, 2009, 10:54 PM

My daughter had the shots at 18 (she’s now 20) and had no side effects at all.

Concerned Teen, 19 July 31, 2009, 12:47 AM

I would NEVER give my children this shot. This shot only protects you from a FEW kinds of cancers. That is only a few, and in my opinion it’s completely pointless. Right now cancer is still a medical mystery. Out of all the money that is raised each year to help us find this cure, nothing has yet to show up. Nor do I think it ever will. This shot will not cure you from cervical cancer! My grandmother died two years ago from breast cancer and i watched her go through all the chemo, radiation, and experimental treatments. It is all one big game. She was alive when this shot came out, and we talked about the potential risks and benefits of it. The risks far out way the benefits, and never in a million years would she allow me to put this harmful shot in my body. My question is, why are we coming out with this shot now? Years ago we were perfectly fine without it.

Lara July 31, 2009, 10:57 AM

I think Dr. Suzanne did an admirable job on the Today show. I was extreamly disappointed that Dr. Nancy tried to shut down the discussion about the potential problems in the long term with this vaccine. The fact is that there are no long term studies, three years of data isnt enough to produce what the FDA considers long term- nor for that matter what we as patients should consider long term. While the FDA reports there has been no link between the deaths and the vaccine, are you willing to take the risk with the life of your daugter for the current benefit? I have a 7 year old daughter and currently I am unwilling to take that risk. I plan to revisit the question time and time again, as we have seen many many times in the past, hind sight is 20/20 (for example HRT, Phen/Fen, Thalidamide- it could go on and on).

Nina July 31, 2009, 12:07 PM

I was always very disappointed in the Today Show segment. Shame on NBC for allowing Dr. Nancy to hijack the discussion and discredit Dr. Suzanne’s comments. Furthermore, to broadcast Gardasil as a Cancer Vaccine was bad journalism. It is a vaccine that protects against some HPV strains that may cause cancer. Not even Gardasil’s own product information is as definitive about the cancer aspect of the vaccine as Dr. Nancy was today.

I posted a question to the show that wasn’t chosen. Here it is:
Dr. Nancy, do you think HPV and/or Cervical Cancer is so prevalent and such a risk to the public health that we need to vaccinate for it?

What is it about HPV and Cervical Cancer that we need a vaccine? That question has yet to be answered. Dr. Suzanne made an unsuccessful attempt today to discuss how serious HPV/cervical cancer are in third world countries, but Dr. Nancy shut her down.
Gardasil is not like any other vaccine a person receives in their life. Please, please, please seriously consider HPV, cervical cancer and the vaccine itself before agreeing to receive it. There is much more to this fast-tracked vaccine than was discussed on the Today Show.


Mary Ann July 31, 2009, 12:44 PM

I appreciated your thoughtful comments on the Today show. I think there are plenty of questions and that this vaccine is still relatively new. I thought your example re: HRT and long term effects was relevant in terms of how long it may take to discover potential unintended effects of any treatment.
My daughter is almost 19. We have discussed this, researched all we can and she has decided she will not be getting this vaccine at this time.

Patricia Vance July 31, 2009, 12:57 PM

I have 2 granddaughters ages 13 and 12 who have received 2 of the 4 Gardasil vaccinations and will not be getting the other 2. The 12 year old (11 at the time) suffered temporary paralysis the same day of the injection, both times. The first time, the hand of the arm injected was paralyzed for several days. The second time, one side of her face was paralyzed for several days. This caused her face to droop on that side and made eating very difficult. It was a very scary thing for an 11 year old. When her mother took her to the doctor both times, the doctor was very uncooperative about reporting the reactions to anyone for further study. We have our suspicions as to why he didn’t report the reactions, but no proof. He actually had the audacity to expect their mother to bring them back for the 3d shot. She informed him in no uncertain terms that they WOULD NOT be getting anymore of the vaccine and that she was not pleased with his lack of concern. Unfortunately, they are on a state run medical program for children’s health care and not able to just go to any doctor they choose. We are very angry about this doctor’s complacency and truly believe that many other doctors, for whatever reasons, are not reporting serious adverse reactions that need to be studied so the true risks of the vaccine are made known. Mothers need to be able to make an educated decision about having their daughters vaccinated or not.

SW July 31, 2009, 2:53 PM

Two of my nieces (perfectly healthy and active girls) completed the series of Gardasil vaccinations. One niece developed a non-malignant breast tumor. While the other niece developed a form of hypothyroidism called Hashimoto’s Thyroiditis, which caused (among other things) weight loss, lack of hunger and lack of energy. She will have to be on medicine for the rest of her life. Her doctor said she needed to get the shots because, “everyone else was getting them.” I had read that one State was going to make this mandatory for all girls within the state to get vaccinated….OMG… I don’t believe that we have seen all the fallout from this drug. There needs to be more education (aside from the false advertising) so mothers and girls can make informed decisions.

merry July 31, 2009, 3:40 PM

Patricia, if I’m not mistaken, isn’t there a way that your daughter can report the incidences on her own? My son had a bad reaction to miralax and there was a way that we were able to make a report without the doctor. We just specified that we were the parent, not the physician, but we still answered as many questions as we could and described the problem, and then it shows up in the database as a parent-reported problem. I would encourage you to look into this further and see if there isn’t a way to get it reported, somehow.

Annon July 31, 2009, 4:10 PM

Don’t miss the book “The HPV Vaccine Controversy: Sex, Cancer, God and Politics” authored by Shobha S. Krishnan, M.D, Barnard college, Columbia University. It is written without the influence of any pharmaceutical companies or special interest groups. The book educates both professionals and the public about HPV infections, the diseases they cause and the role/ controversies surrounding the new vaccines. The Journal of the American Medical Association (JAMA, June 17th 2009) calls the book superb and a terrific contribution to the field. It is available at amazon.com, Barnes and Noble .com and through international distributors. Link to the book: http://www.greenwood.com/catalog/C35011.aspx

Ningu'n Nombre August 1, 2009, 3:16 AM

First of all I think the person recieving the vaccine should have the final say,NOT THE MOM,NOT MERCK,NOT the OBGYN,NOT THE GOVERNMENT!Two I find it odd that this drug is being pushed so hard,playing of peoples’ fear of a gender specific cancer.With YAZ! having to redo it’s advertising PR (“YAZ! is not for PMS,the FDA wants us to clear up a few things, it’s for PMDD and not for PMS and ACNE”,SORRY!),yes I do believe these drug giants (i.e. Beyer[YAZ!] and Merck {Gardi-what-ever-it’s-called]) are playing on fear,going as far as to suggest to the US and the Mexican government that it’s of upmost prudnence;as though all girls will get cervical cancer right of the bat, without the shot.It’s all MONEY ladies, and if I were a feminist I’d be very angry…things are not right,our girls are now money making drug pawns.

E. McKillop August 3, 2009, 3:33 PM

Merck continues to deny that Gardasil is causing side effects and death. Merck also lied about the safety of Vioxx. Do you want to trust your daughter with a drug made by a liar?

peyton August 3, 2009, 10:21 PM

i was wondering what was the most common side effects of this drug?? i have had health issues scince the shot and now i dont have the same dr that gave me the shot,my current dr did blood wrk and everything “looked”fine so where do i go from there??


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