Belly Tales

Chlamydia is the sexually transmitted infection du jour in our clinic. On a daily basis I probably encounter at least one, often 2, and sometimes 3-4 women per day who have it. For the majority of the women I see, learning that they have an STI is often like a wake-up call. They usually get treated, then their partner gets treated, and then, to their credit, they often remain STI free for the rest of their pregnancy. Many of them choose to break-up with the partner that infected them, or stop sleeping with him/her altogether, or else become religious in their condom use. However, sometimes it’s not that easy. In one woman whom I’ve been taking care of since I started my new job (i.e. over 5 months now) she’s had chlamydia 3 times. In other words, she’s been reinfected twice after being treated, probably because her partner has 1) never been treated or 2) keeps getting reinfected himself. In another case, a woman has been treated twice for chlamydia now because her husband has multiple wives, and obviously we still haven’t gotten all of them treated yet. I spend much of my day talking myself hoarse about safe sex, strict condom use and the importance of getting partners treated. And then the CDC releases studies which show that nearly half of all adolescent African American girls have had at least one STI, compared to only 20% of all white and Mexican-American teenagers (keep in mind that the predominant populations in our clinic are African American and Hispanic). It makes me want to cry. We get fifteen minutes alloted to us on our templates to take care of an OB or gynecology revisit. That’s fifteen minutes to conduct an entire interval history, address any questions or concerns, follow-up on lab results and order upcoming tests, do the physical exam (listen to the fetal heart tones, Leopold’s, measure the fundal height etc.), and then write a note on it. Fifteen minutes is barely enough time to tell a woman she has chlamydia, what the treatment is, how important it is that she get treated and then not reinfect herself, how crucial it is that her partner is also treated, and how essential condom use with future partners is. It’s like the tip of the ice berg when really these women need so much more than just counselling on safer sex and strict condom use. They need to learn how to assert their power—how to put their foot down with a partner that may potentially be cheating on them, how to say emphatically “no condom, no koochie” and not buckle in to seduction or pressuring, how to choose and insist on respectful partners. It’s like staring at a huge, roaring wildfire, and your only weapon against it is a tiny fire extinguisher. So what do we do? Keep trying to extinguish the chlamydia, one case at a time, and keep talking ourselves hoarse about safe sex.

So, I’ve been a bit incommunicado thanks to the intensity of my clinical schedule, and the fact that last week was our first exam, and I was busy spending every spare minute studying for it (I’m very pleased to report that I did well on my exam, despite my deepest concerns regarding my sincere lack of study-time). In the meantime, lots of news has been breaking out all over the place, and I’ve been letting it slide. But no longer! Here’s what’s new in the world of women’s health and midwifery news:

First, Merck has recently stated that they’re going to stop lobbying for state legislatures to adopt universal HPV vaccine requirements, in part because of all of the sudden bad press and objections to their lobbying efforts and their fear that continued lobbying would undermine use of the vaccine. Meanwhile, questions continue to arise regarding Merck’s financial invovlement with Texas Governor Rick Perry’s campaign. The CDC has also recently emphasized that no additional warning labels will be placed on Gardasil and that so far, all of the side effects reported with use of the vaccine (mostly inflammation reactions at the injection site and fainting) are low risk.

Since we’re on the subject of vaccines, it appears that research is now targeting Chlamydia for a new vaccine.

A post by Miriam Zoila Perez, the latest NAPW guest blogger, is up on Feministing regarding Radical Doulas.

The Mommy Blawg has a great break-down of all of the latest midwifery legislation being proposed in various states, particularly legislation working to legalize that status of direct-entry midwives (CPMs).

And finally, via Women’s Health News, Tenessee Representative Stacey Campfield has recently proposed legislation requiring a death certificate for each terminated pregnancy in the state of TN, while simultaneously not requiring death certificates for each spontaneous abortion (miscarriage) that occurs in the state of TN. In most states, death certificates aren’t issued until the baby reaches certain gestational age and/or weight requirements, such as 20 weeks, or 500 gms. Since most elected terminations occur during the first trimester, and most spontaneous miscarriages also occur during the first trimester, does it not seem a bit hypocritical to issue death certificates for one and not the other? Naturally, the Tennessee Guerilla Women have plenty to say on the subject. And while Campfield continues to look foolish by trying to deflect attention away from the nitty-gritty details of his bill, NARAL Pro-Choice America has joined the fray by setting up an online form for the women of Tennessee to contact their state representatives.

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.

In addition to the moral debate that surrounds giving Gardasil, Merck’s new HPV vaccine, to young girls, the National Vaccine Information Center (NVIC) is also urging against a “universal use” recommendation by the CDC’s Advisory Committee on Immunization Practices (ACIP) on June 29th. The NVIC doesn’t feel that Merck’s clinical trials proved that the HPV vaccine is safe for young girls.

“Merck and the FDA have not been completely honest with the people about the pre-licensure clinical trials,” said NVIC president Barbara Loe Fisher. “Merck’s pre and post-licensure marketing strategy has positioned mass use of this vaccine by pre-teens as a morality play in order to avoid talking about the flawed science they used to get it licensed. This is not just about teenagers having sex, it is also about whether Gardasil has been proven safe and effective for little girls.”

The FDA allowed Merck to use a potentially reactive aluminum containing placebo as a control for most trial participants, rather than a non-reactive saline solution placebo. A reactive placebo can artificially increase the appearance of safety of an experimental drug or vaccine in a clinical trial. Gardasil contains 225 mcg of aluminum and, although aluminum adjuvants have been used in vaccines for decades, they were never tested for safety in clinical trials. Merck and the FDA did not disclose how much aluminum was in the placebo.

Animal and human studies have shown that aluminum adjuvants can cause brain cell death and that vaccine aluminum adjuvants can allow aluminum to enter the brain, as well as cause inflammation at the injection site leading to chronic joint and muscle pain and fatigue. Nearly 90 percent of all Gardasil recipients and 85 percent of aluminum placebo recipients reported one or more adverse events within 15 days of vaccination, particularly at the injection site. Pain and swelling at injection site and fever occurred in approximately 83 percent of Gardasil and 73 percent of aluminum placebo recipients. About 60 percent of those who got Gardasil or the aluminum placebo had systemic adverse events including headache, fever, nausea, dizziness, vomiting, diarrhea, myalgia. Gardasil recipients had more serious adverse events such as headache, gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis.

Hmm. This certainly throws a new wrinkle in the story.

You can read the full article over at Red Orbit.

The FDA has recently approved Gardasil, Merck’s vaccine that helps prevent cervical cancer caused by Human Papilloma virus (HPV) strains 6, 11, 16 and 18. This is incredibly exciting news, since this is the first vaccine to target cervical cancer, and the first ever vaccine for cancer, period (amazing! a vaccine for cancer!!!). The vaccine has been approved for young women ages 9 to 26, but the recommendation is to give it to girls ages 11 and 12, preferably before they’ve had sex for the first time.

I was listening to a discussion on the radio this morning about Gardasil and the issues that surround its use, and opinions seem to be pretty reasonable on all sides of the debate. Conservative group are not opposing the vaccine itself, but are arguing against making it mandatory. From the NY Times article on the subject:

“Despite rumors to the contrary, our organization doesn’t oppose the vaccine and we have taken no position regarding mandatory laws,” said Wendy Wright, president of Concerned Women of America, a conservative group based in Washington.

Some groups support the vaccine but oppose mandatory vaccinations because cervical cancer is caused by a sexually transmitted virus.

“We can prevent it by the best public health method, and that’s not having sex before marriage,” said Linda Klepacki of Focus on the Family, a Christian advocacy organization based in Colorado Springs.

That’s a very good strategy, but what if the husband you’ve saved yourself for just so happens to have HPV? While not having sex is certainly a sure-fire way to avoid HPV and other sexually transmitted diseases, women can still get HPV on their wedding night from their very first sexual contact. A vaccine doesn’t promote promiscuity, but rather protects you from a very very very very very common STD that many people (men especially) do not even know they have.

Making this vaccine mandatory may help ensure that it’s covered by insurance companies and federal programs which might otherwise choose not to pay for such an expensive drug (a 3-part series over 6 months, costing $120 per shot, so $360 total). From the same Times article above:

A federal program is expected to provide the vaccine to 45 percent of the children in the United States for whom it is recommended. But state programs that cover other children are having trouble buying other expensive vaccines.

North Carolina, for instance, spends $11 million annually to provide every child with seven vaccines. Gardasil alone would probably cost at least another $10 million.

“Increasingly, states are asked to make a Sophie’s choice about which diseases they will allow children to be hospitalized or killed by,” said Dr. Paul Offit, director of infectious diseases at Children’s Hospital of Philadelphia.

It will be interesting to see how all of this unfolds, but for now, it’s enough just to know that this vaccine has finally been approved. As Dr. Sedlis (the guest professor who lectured us on the interpretation of pap smears) jokingly said, if this vaccine becomes widespread, gynecologists are going to be out of a job in 20 years, since pap smears and the mangement of abnormal paps is their bread and butter. This is a vaccine that could possibly someday eliminate the need for routine pap screening for all women, and make cervical cancer, which is already rare in this country, all but obsolete. That’s pretty powerful stuff!

Addendum:
Slate Article: very astute break down of many of the issues surrounding the vaccine, including the costs, benefits and risks and moral issues, well worth reading.
Moderately Insane: HPV Insanity: interesting break down the risks v. benefits of the HPV vaccine, in very plain English.
Women’s Health News post on HPV vaccine, full of amazing resources, per usual.