Gardasil Marches On

Since I last posted on this subject (1/15/06) the Food and Drug Administration (FDA) has approved the use of Gardasil. Gardasil is Merck's vaccine against the transmission of certain strains of the Human Papilloma Virus (HPV), and is intended for use by girls as young as nine and up to age 26. HPV is a viral infection that is transmitted ONLY via sexual activity. It is estimated to cause (between two of its several varieties) upwards of 70% of cases of cervical cancer, which can be deadly. The American Cancer Society (ACS) reports that roughly 9700 women are diagnosed with cervical cancer every year, and of that number, roughly 3,700 will die.

A few facts: Of those women who do contract HPV, 90% or more will clear the infection through natural immune response, requiring no treatment and sustaining no long-term health effects. It is important to note that the vaccine can only prevent infection by HPV (and only two types at that), and NOT treat an existing one. It also can’t protect against other strains of HPV which cause cervical cancer, which the ACS website points out: "It is important to realize that the vaccine doesn't protect against all cancer-causing types of HPV, so Pap tests are still necessary."

Clearly, regardless of what protections the vaccine does offer, monitoring of sexually active women via Pap is still critically necessary: treatment of any precancerous cells found via Pap can stop cervical cancer before it is fully developed.

When I first heard of Merck’s plan for the vaccine, I questioned the advisability of routine and blanket vaccination of very young girls against a virus that can be contracted only through sexual activity. While the FDA approved its use in girls as young as nine, the Centers for Disease Control (CDC) advisory panel, perhaps a bit more sensitive (the idea of 9-year-old girls as sexually active might upset parents!) fudged the age closer to puberty and issued its recommendation for girls 11 and up.

In the interim, Merck has been busy creating a new campaign to raise awareness about cervical cancer called "Tell Someone". Coincidentally, after years of stagnation and lack of profits in the vaccine business, drug companies such as Merck are making a major push to expand the adolescent market for vaccines, which pharma companies believe to be an area of tremendous growth opportunity. (Gardasil itself is administered in three doses over a course of six months, at a cost to the patient--or the insurer-- of $360.00, not including doctor's and other fees.) The campaign’s website should be lauded for getting out the word that this virus is connected to cancer. But it is heavy on the fear factor and just a little coy about clarifying that this particular cancer-causing virus can only be contracted through sexual contact. It takes several clicks to uncover that fact. In the meantime, a visitor might think a handshake or a sneeze could spread it.

However, the American Cancer Society is more upfront:

“You can prevent most precancers of the cervix by avoiding exposure to HPV. Delaying having sexual intercourse if you are young can help you avoid HPV. Limiting your number of sexual partners and avoiding sex with people who have had many other sexual partners lower your risk of exposure to HPV. Remember that HPV does not always cause warts or other symptoms, so a person may have the virus and pass it on without knowing it. “

Not only that, the ACS website is clear on the fact that, for the sexually active girl or woman, testing for the virus is not only possible but fairly easy:

“Doctors can now test for the types of HPV that are most likely to cause cervical cancer ("high-risk" types) by looking for pieces of their DNA in cervical cells. The test is done in a similar way to the Pap test in terms of how the sample is collected, and in some cases can even be done on the same sample. “

The CDC website makes a further point— that is, even if you contract HPV and it causes precancerous cells, you are not doomed to succumb to cervical cancer:

“Regular Pap testing and careful medical follow-up, with treatment if necessary, can help ensure that pre-cancerous changes in the cervix caused by HPV infection do not develop into life threatening cervical cancer. “

Well, that’s good news. Someone can easily keep track of their HPV status and make sure it doesn’t progress to anything more serious. So why do we need blanket vaccination? Especially when the vaccine does not prevent every type of potentially cancer-causing HPV?

Not surprisingly, two Michigan lawmakers recently proposed to make this vaccine mandatory in girls 11 and up. This is an important development as Michigan may set a trend for other states to follow, and a government program which sponsors the cost would increase both sales momentum and the “acceptability” factor of vaccinating young girls against an STD.

So I still object stubbornly to this trend, for a number of reasons. First, safety. The imprimatur of FDA and CDC approval does not make this vaccine safe. Only time will tell that, and only after it has been rolled out in a broad manner among prepubescent girls. For anyone who believes that the FDA say-so is all the reassurance they need, I’d point out that the FDA approved Vioxx and Merck had deep market penetration before that drug’s safety issues became obvious. Merck is fighting hard in court venues around the country as former patients and their families claim death and disability resulted from its use.

Second, there are reasonable options. If one can prevent HPV infections by refraining from or being very careful about sexual contact, and if HPV infections can clear up on their own or be verified by testing, and if HPV-related precancerous cells can be treated before turning cancerous, aren’t there many ways to avoid HPV-related cervical cancer without subjecting your daughter to possible side effects of the vaccine?

And finally, I object because I don’t like the social engineering aspect of it. Here's what I mean. If adult women want this protection, they should be welcome to choose it. And pharma companies have a right to want to expand their customer base. But it shouldn't be our priority to enhance their revenue stream by being obliged to buy a product for which the real need is questionable. I don’t like the effect it has on our cultural psychology: It says that to catch ‘em early, before they start having sex, we need to vaccinate at age nine. Or eleven. What happened to childhood? The medical establishment and the legislators are already buying in. When the grownups start taking this notion seriously, the children will too, no matter what sort of defensive spin you put on it. And there’s no way that can be good for children.

If you want further information, go here.

Comments

[spudmomof6]

I strongly agree. Having two girls, ages 19 and 6, I have a stake in both the pre and post adolescent vaccination push. I wish that pharmaceutical companies would put as much effort in curing diseases that are not caused by behavior (which, obviously, can be modified) and work on those that strike without regard to the patient's health practices. It used to be that when we got 'the talk' about sexual activity from our parents, they could include all the dangers inherent in early and nonexclusive sexual activity. It served the same function as the current truthful but scary tactics we use to keep kids from driving under the influence. Now, what can you realistically say (save the aspect of sin) that they cannot counter with, "That's ok, I'll just take a pill or wear a condom or get a shot and I'll be fine." ADULTS know that the dangers are not all physical; how do we get strong and stable families (with beautiful grandchildren, I might add) if sex is just another recreational activity, like riding roller coasters or watching TV? I feel especially blessed to know that my older children have made the choice to reserve their physical affection for someone committed enough to wait for the marriage covenant, and can only hope that their example and straight talk will help the younger ones make the same decision.

Some will counter that rape is the scenario that changes everything. Been there. That's just one more reason for prompt medical treatment rather than trying to pretend nothing happened. Seeing the psychological damage caused by one incident only makes me more convinced that we will have more problems down the road by making it easier for women to avoid reporting an attack. Fortunately, my daughter has taken back her future and is nearly fully recovered after a year and a half. I shudder to think what she would still be suffering through had she simply been able to get a morning after pill off the shelf and felt she could not turn to her family for help and support.

[Brianna]

I really don't see why you're against this vaccine. Sorry to say it, but not everyone is modest, so what are we to do? "Recommended for children who are likely to become sluts or for those who may not have appropriate health care to prevent the virus from becomming cancer in the future, but all others can wait until just before marriage and can skip it entirely if they trust their husband." Being against vaccination in general, or new vaccines in particular, is another thing entirely (something which I can understand but disagree with) but I really do not think it is fair for you to pick on this one.

[wendy]

Liz, I didn't know that the vaccine only protects against two types of HPV. I have to admit I was on the fence on this one--for some of the reasons Brianna alludes to--but the fact that the vaccine does not protect against all strains makes me concerned. I don't think that this fact has gotten much coverage, and I'm concerned that sexually active young women could endanger themselves more--imagining that they are protected when they're not. Certainly blanket vaccination seems ill-advised when we don't know the long-term effects.

[Elin]

I'm with you, Liz. It's great if the vaccine is available - but I don't think it should be mandatory, especially since Pap testing is still necessary (which would catch ALL kinds of HPV, not just the kinds the vaccine targets).

It has made me angry since I was a teenager (twenty years ago now!) when doctors etc. ASSUME that you are going to be having sex as soon as you hit your teens. And then they look at you as if you have three heads when you tell them you are not sexually active. It makes you feel as if you aren't a "normal healthy" young woman... when, as things like HPV and other STDs show, you're actually healthier abstaining!

I've seen these ads on TV lately about HPV - I didn't realize it was for the vaccine, but here in Canada pharmaceutical advertising is so strictly controlled that it is hard to tell what the product is! The thing is that the ads made it sound as if nobody had ever heard of HPV before! I don't know about the rest of you, but the first time I was offered a Pap smear, at age 20, the doctor told me about HPV. It was on that basis that I refused Pap smears for many years (although by my late 20's the Dr. recommended I have one whether I was sexually active or not) Don't people listen at the doctor's office? Or didn't their doctors tell them?

It seems as if there is a lot of manipulation in the marketing of this vaccine - not only with ads that suggest that HPV is something "new" that isn't already routinely screened for, but which play down the fact that it is transmitted sexually. And then to market it across the board to girls as young as nine? Give me a break!

(I've just re-read Brianna's post. I guess I am showing my national flag again... I just assume that people have access to adequate health care at the stage they need it. I realize this is not the case everywhere. On the other hand, if you have a private health-care system, who is paying for this vaccination? Wouldn't that jeopardize the less fortunate in the same way?)

[Elin]

Sorry, I should have read the original post more carefully - I gather the government, at least in Michigan, is thinking of sponsoring the vaccinations. So that answers my last question.

If the government of Michigan is so concerned about women's cervical health, why don't they do something more useful and sponsor regular Pap tests - since those are still necessary, even with this vaccine? Of course, that would be more expensive. But it also would be more effective. Sounds to me more like it's just a form of Big-Pharma-pleasing window-dressing on the part of the Michigan gov't.

[spinal tap]

Brianna - Could you explain how you "understand" someone being against vacinations "in general", but have issues (as posited by your straw-man recommendation) with a well researched, reasoned position? This seems counter-intuitive.....

This is one of the best "blogs" I've seen. I'd suggest Brianna re-read the post in order to answer her own question. And while not all people (both women AND men) are modest, what we should do is try to foster this virtue in children, for their own benefit.

[Kelly]

Sorry, but I strongly disagree.

First, to clear up some misunderstandings in your post. Gardasil actually protects against four of the main variants of HPV, types 6, 11, 16 and 18. To break it down, HPV 16 and 18 cause 70% of cervical cancer and adenocarcinomas, and 50% of the precancerous histologic lesions, CIN. The four variants together cause 90% of genital warts, which can be infectious and invisible for both men and women, and are not protected against from common prophylactic means (they can be, but as they can grow in areas not covered by condoms, they can be transmitted when you believe you're having safe sex). Since warts can be flat, smooth, internal, or simply invisible, it's extremely hard to get an accurate number of how many cases of HPV/genital warts there are - 200,000 per year is the tallied number, but it's expected to be significantly higher. Unfortunately, the highly cancerous versions of HPV tend to be the ones that are invisible to detection.

It's also worth remembering that HPV is indicated in other forms of genital cancer, as well as soft palate cancers.

Secondly, the vaccine age approval is nothing more than a reflection of the ages that Merck tested the vaccine in. This has practical reasons: most people, by age 26, are infected with HPV. Women who test clean of any of the variants being covered by Gardasil are encouraged to have the vaccine, regardless of their age. While their is not proof it will work, the body really doesn't have an internal clock going "oh, you're 28, so Gardasil won't work in you."

While the majority of HPV cases do clear up on their own, those are the low cancer risk variants that can be unsightly, but cause no real harm. (There are, after all, over 40 variants.) But the vaccine is not targetting these low cancer risk variants, it's targetting the ones that kill.

Gardasil is also one of those vaccines that has been developed not just by the Big Pharma, but in conjunction with the National Cancer Institute, whose interest is in protecting the public, not in benefiting the stockholders. While it's certainly more than sane to be suspicious of Big Pharma's, and to carefully read the FDA decisions, the CDC isn't implicated in or even involved in vaccines on the level you imply. Beyond that, the true test of science is empirical study and peer review - this is where the issues with Vioxx came out, after all. In the case of Gardasil, empirical evidence from around the world backs up the claims of the NCI and Merck. There is nothing in the vaccine suspension that brings any cause for concern, and is in fact the standard suspension for any number of vaccines we give children and ourselves daily.

Finally, though, your argument about "social engineering" and "childhood" are the most spurious. You're suggesting that by vaccinating a 9 year old against HPV, the 9 year old is going to run out and become sexually active. This is hogwash, plain and simple. There is absolutely zero data that would even give this the merest credence - tell me, when you received your tetanus vaccine, did you go out and step on a rusty nail, just because you could? I mean, it might have been painful, but it wouldn't run the risk of hurting you.

This is the exact same logic you're using to argue that Gardasil is going to confer some sense of irresponsible behaviour on girls. But when you take the emotional "omg my baby is going to have sex eventually" aspect out of it, and transfer the example to something as benign as tetanus, the fallacy of the argument becomes clear.

But beyond that? Children receive numerous vaccinations through-out their childhood, and well into adulthood. If you think kids pay any attention to what's being injected into them, you're giving way too much credit to your kids. For them, it's a doctor visit, it's a needle, and that's all. Go up to any 12 year old and ask them what vaccinations they've had - they might be able to list tetanus, especially if it was under a painful circumstance, and MMR, but that's it.

Yes, there are recommendations for avoiding HPV infection, and they're the same for avoiding any STI. But all it takes is sex with one person, and you cannot judge infection visually - there's no way to no. (And this doesn't even address things like date and stranger rape, and the vaccine is not effective after exposure.)

Thinking beyond the self for the moment, there are also future children - fetuses can be infected by HPV upon birth. Many women with precancerous and suspicious HPV are recommended and counceled to have their pregnancies time with a "clean" cervix in an effort to downgrade the risk to fetus.

Yes, it can be uncomfortable to realize that children are going to behave in ways that you don't approve of... but as a parent, your job is to protect your child as best as possible. That means protecting them from danger, and cervical cancer is really, really dangerous. Yes, the short term means acknowledging the sexual potential of your child, but it is, in the long run, the better thing for your child.

[Liz Neville]

Kelly, it's obvious you have a zeal for the subject and I thank you for commenting so thoroughly. On the other hand, I see nothing in your argument or the facts you present that in any way undermine my case. I'd encourage you to reread the facts as I presented them or go directly to the ACS and CDC Websites from which I draw the quotes.

I don't object to the availability of the vaccine, or to adult women availing themselves of what protection it does afford. What I do find objectionable is clearly stated in last paragraphs of the post, so I won't repeat them. But I do wish you'd stopped and ruminated a bit on their basis before launching into such an impassioned "defense" against a case I never made.

[verbify]

Actually, Liz, I do believe that Kelly spoke to the arguments in the last three paragraphs of your post. Where you expressed concern for the safety of the vaccine and compared it to Vioxx, Kelly rejoined that the vaccine has been widely tested beyond the FDA, beyond even this country's borders, and further addressed your point about Vioxx by refuting the analogy. In your second-to-last paragraph, you note that there appear to be many other ways to avoid contracting HPV, and Kelly disagreed by identifying two instances (date rape and stranger rape) which are much more difficult to control. I would add to that list incest, molestation, and the further danger of rohypnol. In your last paragraph you objected to the social engineering aspect of the drug, to which Kelly responded that she felt it irrelevant--the girls (at the very least) would have to be aware of the reasons for the vaccine and the danger against which it is innoculating them for any changes in attitude to be effected. While I appreciate that you are coming from different perspectives, I do think that Kelly responded adequately to each of your major objections. I think that between your posts, the rest of your readers have been presented with an accurate summation of the reasoning and arguments coming from both sides on this issue.

Like you, I am concerned about the big pharmaceutical companies lobbying for mandatory vaccinations in order to line their coffers. It's really tough for me to believe that companies that size work out of any kind altruism. I do, however, believe that the people at the National Cancer Institute work primarily to help people. And I understand (though my understanding of the intricacies is limited) that the research and resources involved in searching for cures and vaccinations against cancer and other health problems is incredibly costly. Thus, to a degree, I see how a company such as Merck should recoup its investment, especially when the product can save so many lives, and when a portion of the money Merck makes will be funneled back into research to address other health problems. And while I also understand your point that HPV does not always lead to cervical cancer and can clear up on its own, I think of the many STIs which can also be treated with general antibiotics, and then realize that I'd never advise a (sexually active) person not to bother with condoms (or, alternately, not to ask their new spouse about his/her sexual history), since only a *few* STIs are deadly.

As has been stated several times in this comment thread, girls' and women's physical safety must overcome hypothetical threats to their morality.

[Liz Neville]

A further note by the author: due to an editing change, a point I made in the second paragraph of the original post is misleading and needs to be corrected. In fact, Gardasil is effective against FOUR types of HPV, not two. The other two types are responsible for genital warts and not potentially cancerous cells and thus were not germane to my point; however I did want to clarify. All the other facts are corroborated by the American Cancer Society and Centers for Disease Control Websites.

[Elin]

Well, I knew it wouldn't be long - last night I opened up a Canadian women's magazine to read "Cancer Vaccine Now Available for Girls" - Gardasil has been approved for use in Canada on girls from 9 to 26. At this point, it is not covered by provincial health plans, so will cost about $400 Cdn., but I'm sure it will eventually be covered (although perhaps not for 9 year olds!) I wonder if it will eventually become mandatory?

Thanks, Liz, Kelly and Verbify for your comments. Lots to think about before I have a daughter (if I ever do).

[wendy]

I am so conflicted on this issue. One of my dearest friends (and the mother of several young children) died of cervical cancer a few years ago. If there is anything that can be done to reduce the death rate, I want women to take advantage of it. On the other hand, I'm nervous about sending a signal to children that the vaccine protects 100% when it does not. I fear this assumption could be more dangerous than not taking the vaccine.

[Constance]

I think the issue is about much more than facing the truth about our children's sexual activities. As parents, we have responsibilities and one of them is to keep our children safe. To accept, in sheep-like manner, that numerous vaccinations are okay and to agree to yet another one really baffles me. We live in an environment that we have limited control over, but to give doctors and pharmaceutical companies the okay to have my child injected with carcenogenic heavy metals would be beyond ignorance. Before advertising yet another toxin, we need to look at statistics from vaccines in general and they are not encouraging. It feels like our society is hypnotised and blindly accepts "drug research." Remember that many of the universities and research facilities are financially supported by the pharmaceutical industry. I completely agree with you, Liz, on the profit factor, though I am opposing the vaccine all together on many levels. Before you submit your kids to the vaccine, read the ingredients and do some research. What you think might be preventing cancer, may yet be another cause of it!

[April]

This is some food for thought. What if the side effect that we don't know about it sterilization. We have a whole generation of women that was made to get the vaccine when they were 11-13 and by the time they decide to have children a whole decade goes by and then we realize ohhh none of our girls can have children. Then what? This vaccine is to young to make mandatory. We need at least 20 years of trials. One trial that was done vaccinated 21,000 women 5 got pregnant during the trial and all 5 had babies born with birth defects.
http://209.85.165.104/search?q=cache:Px7dCSC7B88J:www.healthfinder.gov/news/newsstory.asp%3FdocID%3D532763+Gardasil+dangers&hl=en&ct=clnk&cd=1&gl=us
Think about it!
April

Please read the information on Gardasil at the National Vacine Information Center before having your daughter receive this vacine. The web address is: www.nvic.org. I think many of you will be very suprised at what you read here. After researching as many facts as you can find on Gardasil, then make your decision. Remember the Vioxx disaster. Gardasil definitely needs more testing.

[Shelza]

I am a Gardasil Taker. I think the shot is a good thing. Cancer of all sorts runs in my family and anything I can do to prevent it, I'm going to do. It was actually me who asked my doctor about the shot and my mom supported me 100%. I don't think it's right for you to talk bad about the girls who get this shot. We're taking care of oursleves, and in my eyes, that's very respectible.
So I'm Shelza Blake, 16 years old, and I'm ONE LESS.

[Joanna]

do you people have those "one less" t-shirts?

[Carmen]

I am a 19 year old receiver of Gardasil. I was wondering if you all know where i could get a "one less" t shirt?