The complaint I saw else where that having to go back for three doses, as opposed to one to be just silly. The person making is obviously hasn't been paying attention to the vacinations recommended for his child previously, as many require more than an initial dose (DPT anyone?). The other required at the middle school/jr high juncture (Hep B isn't it?) also comes as 3 doses over something like 6 months (my kids had those 6 and 9 years ago, so my memory is a bit muddled)
There are two sides to every discussion, of course. This vaccine does appear to confer some benefits. If I were a sexually active woman who disliked condoms and liked to have multiple sex partners who had not yet been exposed to any of the four strains of HPV that this vaccine protects against, I just might sign myself up.
But that's not the same thing as making this vaccine MANDATORY for a preteen population it was not rigorously tested on a scant 8 months after its initial rush job FDA approval.
Aside from all the known risks of all vaccines, the unknown risks of this three shot regimen for preteens along with their other vaccine load, and the unknown long term risks of this vaccine for all populations, we have to look at cost vs. benefit.
7861 of the placebo subjects contracted 83 cases of HPV 6-, 11-, 16-, 18-related dysplasias during the testing period compared compared to 4 cases among the 7858 subjects who were given GARDASIL. That's after counting out every subject with any prior exposure to these strains. This includes 42 of the less serious HPV 6-, 11- related low grade dysplasias.
Merck has published no data for how many non-HPV 6-, 11-, 16-, 18-related dysplasias were contracted by these subjects over these periods, but some practitioners have commented that they expect the vaccine to protect against 40%-50% of all dysplasias.
In terms of every possible kind of dysplasia for which this vaccine confers protection, Merck's own clinical evidence suggests that this vaccine saved about 10 patients out of each 1000 injected from the painful process of having these dysplasias treated (over the entire course of follow ups which ranged from 18 months to 4 years). Note that the populations for these studies were not preteens but women at the height of their sexual activity. Further note that since the vaccine uses virus-like particles (a new vaccine technology) and is only about five years in testing now, there is no guarantee that it has any long term efficacy.
Of course, the pre-teen population is so less sexually active (and when active, so much less likely to be active with a previously contaminated partner) that I think it would be conservative to estimate that preteens are 5 times less likely to contract HPV dysplasias than the 16 to 26 year olds who were tested by Merck. So instead of saving 10 women per 1000 from painful treatments for HPV dysplasias, this vaccine would save perhaps 2 girls per 1000 from these procedures among the much younger population that Merck and Merck's politicians are targeting for mandatory vaccination.
Do we really want to pursue a public policy that costs $360,000 to vaccinate every 1000 girls while exposing each and every one of these thousand girls to the known adverse short term and largely unknown long terms side effects of three injections of a new vaccine just to save two of the more sexually active of these kids from having to have their dysplasias treated conventionally? What
What kind of a risk and cost vs. benefit trade off is that?
Note that nowhere are we discussing actual incidences of cervical cancer because there is no clinical evidence whatsoever that GARDASIL reduces cervical cancer rates, and even if we place our hope in the the fact that it might, cervical cancer is simply not a meaningful health risk for any girl in the target vaccination population who is getting an annual pap smear.
While it is a widely accepted medical theory that HPV "causes" cervical cancer, it's not close to being a fact. Although the vast majority do, many cases of cervical cancer don't show any association with HPV. It's a very good guess that certain strains of HPV are necessary co-factors for certain highly prevalent types of cervical cancer to emerge. The two really bad strains protected for in GARDASIL go hand in hand with 70% of current cervical cancer cases. My point is that there are 36 nasty strains of HPV screened for currently, and the human body is an ecology. We have no idea how protection against the two strains of HPV that are currently most prevalently associated with cervical cancer (typically decades after initial exposure) will affect overall cervical cancer rates far in the future.
What we instead DO know is that current practices of annual pap smears and screening for ALL bad strains of HPV continue to reduce rates of cervical cancer among the US population annually. If all US women received a pap smear every year and were then promptly treated for any abnormal growths encountered, both the cervical cancer contraction and mortality rates would plummet even further to the point where HPV-associated cervical cancer would kill no more than a handful of US women a year. Yes, that is a guess as well, but it's a far better guess than assuming that conferring protection against four of the myriad of current and future strains of harmful HPV will somehow do the trick.
Yes, GARDASIL's benefit data against the four strains of HPV it targets are compelling. HOWEVER, the benefit data against ALL forms of HPV are not published by Merck and estimated by OP-GYNs to be a mixed bag. The benefit data against cervical cancer itself are nonexistent. The long term risk data for any population are nonexistent. There are almost no risk data at all for pre-teens. The fact that the "placebo control" was a shot of alum that was recently shown to cause neural death in mice is particularly problematic in terms of interpreting the small amount of risk data that were gathered.
Studies of the long-term benefits of a new drug or vaccine take a long time. It would take several decades to prove conclusively that this vaccine prevents cervical cancer deaths. So why the rush to make these three injections COMPULSORY for preteens?
Perhaps this would be excusable if GARDASIL conferred protection against HPV generally, but it does not. We have absolutely no way of even guessing how conferring protection against four strains of HPV will affect cervical cancer rates decades down the line. If you do, please quantify the expected benefits in terms of the expected reduction of cervical cancer contraction and mortality rates for the population of US women who get annual pap smears. The only thing you can say about this number is that it is unknown and tiny.
I am not trying to stop anyone from signing up themselves or their kids for this. If you want to pay $360 to make your little girl one of Merck's test subjects, please do. As I said, the vaccine shows promise. It may be a life saver for a small segment of the population (especially those too poor or uninformed to get annual pap smears), and it offers protection against most genital warts and a good percentage of HPV dysplasias. The procedures to remove these warts and dysplasias are very painful, so these benefits are compelling. However, the risk and cost vs. benefit profile of this vaccine is not such that it is good public policy to mandate it -- especially not for a pre-teen population on which it has never been sufficiently tested -- even with an "opt out" clause. If Merck wants to make sure that women and parents who want it and can't afford it can get it, they should offer it to low income individuals and families on a sliding scale rather than lobbying state and federal governments to pony up the billions.
If stick dog were a sexually active woman who disliked condoms, it would probably be too late for "her" to be vacinated against HPV. The age was chosen Because most 6th and 7th graders aren't sexualy active yet.
The rest? See this link. (Thanks, Elizabeth on the Pandagon thread.)
http://emc.medicines.org.uk/emc/
...ocumentId=19016
Typical. I considered EXACTLY your point in what I wrote. Read it again.
Then you act like some link answers all my facts, points and concerns!
Why don't you just stick you fingers in in your ears and shout "la la la, can't hear you" instead? Because that would make for as effective a discussion.
For a full discussion on this issue click on my homepage. In the meantime, here are MY sources --
Merck and the FDA: http://www.fda.gov/cber/label/
hp...mer060806LB.htm
NY Times: http://tinyurl.com/2cyzsj
and concerning the new evidence that alum injections cause neural death in mice:
http://www.straight.com/article/...w-sinister-
side
http://tinyurl.com/3xhtdz
As I was only responding to the one point specifically, that if the specific you set out were true it would be too late for adequate protection for the majority of women, you are vastly over reacting. My 1st comment also only remarked on 1 particular arguement, not the value of all.
The link did have information about HPV taken with hep B (that innoculation load you mentioned). That it does confer some immunity reaction in boys, etc. That it has been studied in more than just the study you cited. So, we should disregard Elizabeth's link why? Because it's UK rather than US? Because it's not published in NYT?
Who is sticking their fingers in their ears here? That would be you. I questioned and disagreed with your conclussions, I did not claim all your info was wrong or that your conclusions were wholy baseless. Grow up.
Since i'm still irritated by your absolute dismissal, I'll point out that the study does not disagree with you completely, in fact supports some of your points. The fact you didn't bring this up in your tirade indicates you did not even look at the link in anything more than a cursory fashion.
Great post, Sarah. thank you.
This is a situation where parents should talk to their family doctor (whom they presumably trust), to get all of the information before making a decision. Sara of http://www.parentingwithsara.com just wrote a column about this, illustrating how parents can become confused when they lack information. cheers, tk
I was diagnosed with HPV in 1991 when I was 19. I am now 34 and since then have endured over 35 pap smears, about 8 colposcopies & a few biopsies. It's not a fun course. I know some people out there know what it's like to sit & wait for a pap smear result to come back. You don't know if there's going to be a section of abnormal cells or not. If there is it leads to another test. If not, a follow up pap in six months. I have had so many biopsies of my cervix it was hard to have children. I had one miscarriage where I was bleeding so much they were using bed linens. I had one child premature 3 months because I couldn't keep her in because my cervix was so beat up. If the side effects of Gardasil are at the injection site and there are a few cases of arthritis, I would rather have my child endure that than what I have been going through. I have 2 little girls & I will make damn sure thay receive those shots when the time comes. It's not a matter of promoting your daughter to have sex earlier if she gets the shots, it's a matter of educating her. And parents that don't want to do that should just have their doctors administer the shots with regular vaccinations and not even tell them what it is.
Shannon, I hope I didn't give the impression that I don't want people pursuing this vaccine. Even on the cost side, I imagine that it's cheaper to administer the vaccine regimen than it is to give pap smears every year for a woman's adult life. I'm just uncomfortable with the idea of requiring Gardasil at such an early date.
(And as it happens, I've been unfortunate enough to have a few irregular pap smears in my day, so I can sympathize with what you've been through.)
Does anyone even know the full side effects? I was all excited working in the field of gynecology to beable to have my daughter 17 vacinated. 9 out of 10 abnormal papsmears are due to some type of HPV. I knew my daughter was sexually active and had discussed with her the benefits of condoms and other protection measures. So my daughter started to receive the Shots, her second shot was 06/27/07 and became pregnant on or around July 18, 07. She is due in April and expecting a baby girl (sophie). I now regret being so excited to have my daughter vacinated. She was on birthcontrol so she was not trying for a pregnancy, but unexpected things do happen and in her case it did happen. At 16 weeks she was offered a MSAFP QUAD screen which came back positive for Down Syndrome a 1:9 chance, which is a very high chance that she does even though she has no factors that come in to play. Her or her Fiance have no family history of Down syndrome or any form of birth defects, or her age has no factor. We are going to be doing furthor testing to confirm. But will not be 100% sure until the baby is born. So in my opinion and if you were thinking about giving this shot to your daughter i would have to discourrage you. We will love this precious little girl no matter what the outcome. But i personally believe had it not been for this shot the outcome would not have been this way.
Thanks
wromero
This vaccine seems a little rushed. You might want to consider the fact that there have been some very, very weird side effects. Soem girls having fainted or having seizures. Also, why 12 year old girls, and why now? I t seems that this vaccine would be meant for women with more active sex lives. So why all the 12 year old girls? Also the vaccine is said to only last for four years. Even weirder yet are the test results which no one heard about. This vaccine is not for pregnant women, but they only figured that out AFTER five out the pregnant women tested on had children with deformities and phsycological problems. Overall, I don't think I'd let my daughter take the vaccine yet until we know more about it. If we suddenly figure out that thsi vaccine causes some side effect that could be potentionally life altering then I geuss I made the right decision.
Pelvic pain
Severe stomach pain
Pain, swelling or stiffness in joints
Pain, swelling, redness or itching at the injection site
Mild fever
Nausea, vomiting, diarrhea, upset stomach (always)
Dizziness (often)
Runny or stuffy nose, sore throat, cough
Muscle pain and general weakness (constant)
Fainting (2 times)
My daughter has recvd 2 of the vaccines/shots and will not get the third. She has been hospitalized (ER) twice over the past 5 months. Once, by ambulance from her college dorm. Diagnosis: NONE-stress etc due to college life. They ran all the blood tests, MRI of her head (fainting), ultrasound for ? of gallbladder disease/stones--all negative. Next, they want to run GI series. Of course, I will have these test, in fear that there could be something else but I am so sceptic now after reading all these reports and blogs...
My daughter is an athlete, plays college Lacrosse, and is in such pain all the time now. She NEVER had any of these symptoms prior to recving this vaccine. PLEASE, think twice about having your daughter receive this vaccine. Educate yourself and her about the ramifications of this drug. Teach her to abstain instead of feeling the pain from this drug... even death (God forbid)---there have been at least 11 deaths to date and over 4000 reports of negative reactions...
I can understand the fear...which is why I had her take the vaccine to begin with...I now wish I had not. My daughter loves sports and cannot play now, this would have been her 2nd year playing college lacrosse and it is just destroying her "college" life feeling the way she does. Shoulda-coulda...wish I read more about Gardisil before having her take it....
http://www.judicialwatch.org/
arc...AERSReports.pdf
So, here's my beef. I understand the risks of cervical cancer and of its treatment. I've done my research on that. My main reason for starting the Gardasil regimen is that I quite simply do not want genital warts and am willing to take this step to prevent them. However, when I look to see WHEN the vaccine starts working, I have not been able to come up with ANYTHING. I know that it takes the three shots over six months for the vaccine to be permanently effective, but what about those six months where a woman such as myself is sexually active? I diligently use condoms, but their effectiveness is only 70%. The only reason I can see is that they don't want to disclose such information and run the risk of being sued.
Commenting by HaloScan
