HPV Vaccine Nearly Ready to Roll

Last week brought the much awaited news that the FDA has cleared the path for approval of Gardasil, Merck's HPV vaccine that promises to significantly reduce the risks of cervical cancer to women who are vaccinated before exposure to the virus. The studies reported that none of the women who received the vaccine developed precancerous lesions of the cervix during the study period! And, that's great news!

Not only will the vaccine most likely significantly lower the rates of cervical cancer, but there are other great benefits as well: there will be way-fewer rates of genital warts (condylomata), because the vaccine also protects against some of the "low-risk" HPV subtypes. And, there will be significant cost savings by reducing the numbers of colposcopies, treatments, and follow-ups of these problems. Many of our young patients will be spared the sometimes traumatic first experiences with a gynecologist that these problems sometimes dictate, and they'll avoid the potentially fertility-risking treatment procedures such as LEEP and conization.

There's a lot that will need to be worked out and perfected with this in the years to come, like how to effectively vaccinate adolescents before they're sexually active, whether to vaccinate boys (the vectors) or not, and whether to include additional less prevalent viral subtypes in the vaccines. But this is a great start.

Gynecologists see enough HPV-related disease to understand the importance of vaccination, but the problem is that we frequently don't see young women until after they've become sexually active. (See my previous blog entry about new thoughts about timing the first visit with a gynecologist.)

We need to be sure to do what it takes to educate and get buy-in from pediatricians, family-practitioners, and parents to make this work.

The big picture is that 75% of high school students admit to having premarital sex, and that's where these problems frequently start. As with most things, we tend not to address issues unless they're right in front of our noses. The prospect of near-future sexual activity is something that most parents don't want to think about with their young teenagers, but we're going to have to get over that hump and make this vaccination a standard of care if we want to prevent this disease.

A couple of disclaimers: The availability of the vaccine in no way sends the message that having sex may be taken lightly. Abstinence and safe-sex programs still have their roles in pregnancy prevention, disease prevention, and psycho-social indications. And, the vaccine will not eradicate the need for a yearly gyn checkup and cervical cancer screening. Just because there will (hopefully) be far fewer abnormalities, doesn't mean we'll quit screening for cervix cancer and other problems.

RW, MD

Related Topics: WebMD Video: Will a Cervical Cancer Vaccine Soon Be a Reality?, How Long will the Cervical Cancer Vaccine Last?

Technorati Tags: gardasil, cervical cancer vaccine

Are Periods Passe?

The Choice to "Opt-Out" of Menses....

There's a lot of discussion these days about taking oral contraceptives in unconventional ways to delay or avoid menstruation. Seasonale, a birth control pill that's been available since 2003, extends a woman's cycle length to three months, so she only has withdrawal bleeding (a "period") quarterly. Now, there's news that Wyeth is seeking FDA approval for Lybrel, which is taken daily, continuously without monthly or quarterly breaks, and will optimally eliminate withdrawal bleeding altogether!

When the pill was developed, the 21-on, 7-off formulas were instituted in order to mimic normal cyclic menstruation. But, the timing is arbitrary - who's to say that bimonthly, quarterly, semiannually, or no periods at all aren't just as good? For years we've presecribed oral contraceptives continuously for women with endometriosis. And, we have frequently recommended short-term variations in pill-taking strategies for women who want to avoid their periods during their weddings, or vacations. It usually works....but not always.

Hormonal contraception has been around for a long time, and there's plenty of information and experience that says it's relatively safe and efficacious for large numbers of women. It even prevents problems for some women, or keeps them from worsening, as with ovarian cysts, endometriosis, and ovarian cancer. But, some women choose not to take them due to hormonal side-effects or intuition...

There are probably not different health risks or danger to fertility by taking oral contraceptives in creative ways to control or eliminate menstruation vs. conventional formulations. But, there are not any long-term studies of large numbers of women that prove this safety. (We thought that postmenopausal women could take continuous progestin to avoid withdrawal bleeding - a supposition that turned out not to be the safest choice...) Intuitively, I believe that if a woman chooses to take oral contraception, there are probably not significantly different risks no matter how she takes it, but I can't say that with authority.

I predict that the acceptance rates of the new formulations will be determined by the efficacy they have in eliminating unwanted bleeding. Wyeth claims that Lybrel stopped 71% of women's bleeding after seven months...but what did it take to get through those seven months? Was there unexpected and nagging breakthrough bleeding? And, what about the other 29% - how long should they tolerate unexpected bleeding in hopes that they'll eventually stop?

My experience is that women would rather know when to expect bleeding than be surprised by it. They're unlikely to put up with random breakthrough bleeding for more than two or three months, even if they're reassured that it's to be expected and it's safe. And, I know that I can't predict which women are good candidates for extended or continuous hormonal therapy.

So, unless these newer formulations are better than conventional OCs at preventing breakthrough bleeding, they're probably not going to work for a majority of women, unless we're able to create a paradigm shift in their thinking that it's worth putting up with unwanted bleeding for six months or longer in order to achieve no-menses nirvana.

RW, MD

Related Topics: Message Board: Birth Control Options, Birth Control Overview

Technorati Tags: Seasonale, Seasonique, Lybrel, birth control

First Ob-Gyn Appointment for Girls

I just attended the Annual Clinical meeting of the American College of Obstetricians & Gynecologists in Washington, DC last week. I was interested to hear that a recommendation of an ACOG Task Force is that adolescent women (girls?) between the ages of 12 and 14 are now encouraged to have an appointment with an ob-gyn physician before they become sexually active. I mention this because many of my patients have asked me over the years, "when should my daughter have her first visit?"

The purpose of the early visit is not necessarily to perform an examination or Pap smear. Unless she is having problems with her periods, an exam really isn't necessary. It is merely a chance to have a conversation during which reproductive health topics may be discussed, and questions answered.

It is the opinion of the task force that these subjects are not being adequately covered by school programs, pediatricians, and family physicians, and that early education and familiarization with ob-gyns will help decrease unplanned pregnancy and sexually transmitted disease in this vulnerable population. Providing a link to an ob-gyn practice will hopefully improve access to birth control and emergency contraception, as well as STD information and screening, and abstinence support. And, with the new HPV vaccine that will be available this year, it seems prudent to get the word out there about cervical cancer prevention.

I think this is a great idea. Since 75% of high-school students now admit to having sexual intercourse, it seems the earlier the better to initiate these conversations.

Related Topics: Media May Prompt Teen Sex, Teen Virginity Pledges: Can They Work?

Technorati Tags: teens, ob-gyn, reproductive health, sex education