Over 24 million doses have been distributed in the U.S. But how safe is it? Momlogic investigates.
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-BarrĂ© 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.
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.
Would you allow (or have you allowed) your daughter to get the Gardasil vaccine? Why or why not?
|Dr. Suzanne Gilberg-Lenz completed her undergraduate education at Wesleyan University and post-baccalaureate pre-med studies at Mills College. She earned her medical degree from the USC School of Medicine and has been in private practice for 9 years. She is the co-founder of Cedar Sinai Medical Center's Green Committee and lives in Los Angeles with her husband and two children.|
|Dr. Hilda Hutcherson is a clinical professor of Obstetrics and Gynecology at Columbia University. She has written three books, including "Pleasure: A Woman's Guide to Getting the Sex You Want, Need and Deserve." She lives in Pelham, New York with her husband and four children.|