Texas HPV vaccine controversy

Texas governer Rick Perry has recently signed an Executive Order requiring all girls between the ages of 11 and 12 to be vaccinated with Gardasil, Merck’s new HPV vaccine, which is currently the only vaccine on the market that treats HPV (other HPV vaccines from other companies are in the pipeline and soon to be approved by the FDA). In response to this, Texas legislators have recently proposed a new bill to remove Gardasil from the vaccination list required by TX law for entry into public school.

Governor Perry’s Executive Order has kicked up a lot of dust. While many people initially opposed universal HPV vaccination under the premise that it would encourage promiscuity in teenagers and women, concerns about the safety of the vaccine, as well as its long-term effects, have also been raised. From a legal standpoint, many people feel that requiring HPV vaccination for entry into school is an enfringement on their rights, particularly since the public health need for this vaccine is not as pressing, given that HPV is not an airborne or contact communicable disease that can be transmitted at school, but is actually an STD requiring genital to genital contact, and the rates of cervical cancer in this country are actually very low (annual pap smear screening for cervical cancer is one of our greatest public health success stories!). Questions have also been raised about the motivation behind this vaccine, given that Merck was a contributor to Perry’s campaign fund, and Merck alone stands to profit from routine vaccination of all girls in Texas, which the New York Times is estimating will cost at least 60 million.

Rachel over at Women’s Health News has posted three very thoughtful posts about this new law which encapsulate much of the current debate. The comments from her readers in particular are very telling:

1) On the Texas HPV Vaccine Law, 2) Backlash against Texas HPV Vaccine law continues, and 3) HPV Vaccine Concerns

For my own part, I would like to address some of the misinformation about the HPV vaccine that is floating around right now. From a reader on Rachel’s site who was arguing against universal vaccination: “…2) There are 15 types of HPV. The vaccine, created by Merck, which has received so much media attention, protects against 2 types of HPV. These two types are implicated in causing 70% of the cervical cancers that develop. 30% are caused by the 13 other types of HPV which this vaccine is no protection against.”

There are actually over 100 genotypes of HPV which have been discovered to date, of which approximately 30 strains are found in the genital mucosa. Of those 30 strains, 15 have been shown to be associated with cervical cancer, in particular types 16, 18, 31, 33 and 35. These types are considered the “high risk” strains and are usually subclinical/ non-detectable. Approximately 70% of cervical cancers result from infection with HPV genotypes 16 and 18. In contrast, HPV types 6 and 11 are considered “low risk”, and are responsible for 90% of all cases of genital warts (i.e. highly clinically detectable). HPV is spread through direct genital to genital contact, and can be transmitted even when using a condom, since a condom does not cover the entire genitalia.

Gardasil is a quadrivalent human papilomavirus L1 virus-like particle vaccine which offers protection against HPV genotypes 6, 11, 16 and 18. In other words, the two strains that are most often responsible for cervical cancer, and the two strains that are most often responsible for genital warts.

However, as many readers have pointed out, Gardasil only offers protection for 2 of the 15 genotypes associated with cervical cancer and only 2 of the genotypes that cause genital warts, and the research is not conclusive on how long Gardasil is able to offer protection, or whether booster vaccines will be needed at a later date. It is also important to note that all of the research on this topic has been funded and carried out by Merck. Most importantly, the pap smear has been a highly effective screening tool for cervical cancer since the 1960s, responsible for early detection and treatment of cervical dysplasia, and the number one reason why cervical cancer rates are so low in this country (although still disproprotionate: cervical cancer rates are highest for low income and uninsured women). Worldwide, cervical cancer is the second largest cause of female cancer mortality, with an estimated 493,00 new cases each year and 274,000 annual deaths. In other words, even if you do choose to be vaccinated with Gardasil, annual pap smears are still crucial.

It will be interesting to see how this plays out, both in the media and in the legislature. It will be interesting to see if other states follow Texas’ lead. The HPV vaccine is an extraordinary breakthrough, the first vaccine ever created that actually targets cancer, but as with any new vaccine or drug touted as a new miracle, I think a little caution in the beginning is well founded, since new research is still incoming and the long-term effects are unknown.

Source: ACOG (Sept., 2006) ACOG Committee Opinion #344: Human Papillomavirus Vaccination. Obstetrics & Gynecology, 108 (3), Part 1: 699-705.

This entry was posted in Choice, Gynecology, Politics, Primary Care, STIs, Women's Health. Bookmark the permalink. Trackbacks are closed, but you can post a comment.

5 Comments

  1. Posted February 8, 2007 at 4:45 pm | Permalink

    Thanks for the clarification about which strains are covered by the vaccine. It really frustrates me when people concerned with public health decide they don’t need to worry about giving enough information for people to make informed consent to a treatment. :-p

    On a tangential note… yeah, PAP smears have done wonders for decreasing cervical cancer. I think they’re also more stressful for women than they need to be. It needs to be acknowledged that it’s an invasive, uncomfortable procedure and it should be done no more frequently than actually necessary. If a woman has had an ASCUS result, but the HPV genotype is found to be one that is NOT associated with cancer, the doctor still wants you to come back in 3 months, then 6 months, then 6 months again, just to make sure it didn’t turn into cancer… but at that point why is there any increased risk?

    Also, the implements they use to take the sample have changed in recent years. Instead of the “popsicle stick” with the wide, curved end, there are a couple different plastic spiky devices used in sequence. Maybe I have more nerve endings on my cervix than average, but these things HURT, and it continues to hurt for a day or 2 afterward! The first time they were used on me, I didn’t see them and didn’t know to expect anything different, and I was wondering if I was crazy afterward because I felt so invaded and uncomfortable. The next time, I saw the tools laid out and realized what had happened. The doctor said, basically, that this is what they always use now, and too bad if I don’t like it.

    I have always followed up with routine care, but I am really close to deciding to refuse regular PAP tests because of these concerns. It would make a really big difference if the people in the doctor’s office showed any understanding. It’s a great practice in most other ways… but like everyone else they just consider PAPs as simple and ordinary as taking someone’s temperature. It’s not that easy.

    Sorry for venting on you. But I figure that you, Ms. Midwife, might actually be able to use this information in some useful way, so it might be worth sharing.

  2. The Student
    Posted February 8, 2007 at 6:55 pm | Permalink

    Hmmm. I think you’re talking about the cytobrush,

    which is a wire instrument with a bunch of stiff plastic bristles on the end that is twirled inside the endocervical canal to collect cells from the squamocolumnar junction, and is used in conjunction with the spatula (the popscicle stick with the wide end). Or maybe you’re talking about the cervical broom or cytobroom, ,
    which has a head on it that actually looks a little bit like a plastic broom with softer plastic bristles. The cytobroom is used for liquid based cytological methods, like the Thin Prep pap, rather than the older slide and fixative method, and the cervical broom has become the instrument of choice for gathering samples because it is supposed to gently swipe cells from both the endocervical canal and the ectocervix (so that you don’t need a spatula AND a cytobrush, just a broom), and is then twirled vigorously in the liquid medium to release the cells into the liquid. When the cells are eventually examined under a microscope, they’re generally much easier to see because they have essentially been “rinsed” by the liquid.

    In my own experience, I have found that it’s the cytobrush that usually causes a little bit of bleeding when you twirl it inside the endocervical canal, especially in friable pregnant cervices, and is often the most uncomfortable part of the pap. The cervical broom seems gentler, because the plastic ends are softer and more forgiving than a wire brush with stiff bristles. But I do absolutely believe that women can feel their cervices, and that for some women a pap might be much more painful or sensitive than for others. If a care provider has an attitude of “too bad if you don’t like” it, though, why would you go back to that same provider?

    Paps suck. While routine, they really are an uncomfortable and invasive procedure, and they do make you feel very splayed and very vulnerable, and as a provider who does paps on a regular basis, it would be good to NEVER lose sight of this!  (My own memories of speculum exams being performed on me by fellow students when we were learning how to insert speculums last year are still quite fresh, so no worries about me losing sight of this any time soon!) As a rule, paps are always the very last thing you do during a physical exam, because after the pelvic is finished, she’s ready to hop off that table, reclaim her dignity, and put her clothes on as fast as humanly possible. A few things I have begun to do routinely (recommended to me by Nazelgaving Midwife) is to give the woman a tissue before the pap even begins, so that she feels like she has some measure of control and can wipe and clean herself up immediately afterwards instead of having to remain with legs splayed waiting for someone to hand her a tissue, and the other thing I’ve been trying to routinely do is to compliment every woman’s cervix in some way, especially because that’s such a hidden, secret and sometimes embarassing or frightening part of a woman’s body, and how nice to undo some of that negativity by telling a woman she’s actually beautiful? Another trick I recently learned from one of my preceptors is to apply a very thin layer of gel to the outside of the blades of the speculum (not the tip, which actually comes in contact with the cervix and can mess up sample results) so that when you’re sliding in the speculum, it actually slides just a little bit, instead of getting stuck and tugging on sensitive tissue. We were taught in school to only use warm water on the blades so we wouldn’t interfere with the sample results, but the water has usually dripped off the blades by the time you get from the sink to the woman, and it isn’t the best lubricant in the world anyway. The preceptor who taught me this trick argued that the lubricant, if applied to the blades only, will usually collect near the entrance to the vagina (introitus) as the speculum is being slid inside, and therefore doesn’t come anywhere close to the cervix, where it can alter sample results (but does make putting in the speculum a lot easier). I’m still not sure if this is the best idea in the world, but I have tried the lubricant method once now and I do think it does make the entire procedure a little bit more comfortable for the woman.

    As for ASCUS follow-up: according to the latest guidelines (ACOG Practice Bulletin No. 45, Aug, 2003), if a woman has pap results with ASCUS (atypical squamous cells of undetermined significance) but her HPV DNA capture test is negative (i.e. she is not infected with high-risk HPV strains), the recommendation is to have her return for repeat follow-up paps at 6 months and 12 months. I don’t understand why anyone would recommend coming back at 3 months, where the results would most likely be the same and no new information could be gleaned from having another pap so soon after the last one. On the other hand, if the HPV DNA capture tests are positive (i.e. the woman is infected with a high-risk strain of HPV), the recommendation is for colposcopy, just to make sure there isn’t any precancerous lesion present.

    Thank you for forcing me to review all of this cervical cytology stuff, which I haven’t thought about in quite some time now! Not sure if this was helpful at all, but maybe it was, and as ever, thanks for the reminder that paps really are invasive, no-fun procedures. They are becoming very routine for me…reminders are good!

  3. Posted February 10, 2007 at 9:05 pm | Permalink

    Thank you. It helps to have the right words to use, and some sense of what other practitioners do, when I try to talk with the doctor.
    I think this practice uses the cytobroom and then the cytobrush.
    :-S
    Have you heard anything about better or worse times in the fertility cycle for doing a PAP? Like, if you’re fertile and the cervix is more open already, is a PAP less likely to scrape things up?

    They didn’t actually tell me “too bad,” they just didn’t seem to have any alternative to offer and didn’t seem that concerned. Also, you’ve made me notice that I’ve been generalizing — the person I had that conversation with was the physician’s assistant, who I’ve had other concerns about as well. But she’s not my regular doctor. So one thing I can do is have a conversation with my regular doctor about this before I assume the attitude of the whole practice. Unfortunately, the PAP was equally uncomfortable when each of them did it. But at least the attitude might be better.

  4. Posted February 11, 2007 at 10:00 am | Permalink

    What a fantastic blog entry about the HPV vaccine. I have been fired from my blogging position *sniff* and was busy transitioning my site during this whole controversy, and I have yet to do an entry on it.

    I love the way you, feministing and Rachel have covered it, and I am so tickled that the blog writers I subscribe to read each others’ blogs.

  5. The Student
    Posted February 11, 2007 at 5:15 pm | Permalink

    Awww, thank you for reading! Good luck on your site tranisition, Hilary.

    Becca: I have no idea if there’s a better or worse time to do a pap in terms of sensitivity and comfort, although your thought regarding ovluation as being a particularly sensitive time makes a lot of sense to me. I wonder if there’s any research out there on this? I doubt it, but I guess it would be interesting to check anyway. Hopefully talking with your doctor about your discomforts will indeed reveal a different attitude, which may make a huge difference with regards to how you feel. Take care! :-)

Post a Comment

Your email is never published nor shared. Required fields are marked *

*
*

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>