Plan B

After stalling for years, the FDA has finally approved Plan B, a form of emergency contraception, for over-the-counter sales. That means that a woman will be able to step up to the drugstore counter and purchase it without a prescription and without a pharmacist's blessing, if she can prove that she's at least 18 years old. Younger women will continue to need a prescription.

The policy to restrict the sales to adults in drugstores seems arbitrary, especially in the face of all the unplanned teen pregnancies. It seems to me that any policy that would make the medication conveniently available, even in gas stations and convenience markets to anyone who thinks she might need it would have been more prudent. The only downside to taking it "incorrectly" seems to be decreased efficacy, and the easier it is to get, the better it might be utilized.

There are arguments that making emergency contraception more available will increase promiscuity and unsafe sex. But research shows that more than half of the pregnancies in the US are unplanned, which means there's a lot of unintentional unprotected intercourse going on anyway. If EC provides an option to reduce unintended pregnancies after the act, it makes sense to me to have it readily available when it is needed.

Emergency contraception, when used properly, decreases the chance of pregnancy from 8% to 1%, which is a significant reduction. But, it must be taken within 72 hours of unprotected intercourse, and, the sooner the better. It does not protect against sexually transmitted disease, and, it should not be used for routine contraception.

When it comes to how Plan B's availability, it seems that politics prevailed, but at least approval is here in some form.

-RW, MD

Related Topics: Many Teens Use Condoms Incorrectly, Teens Still Look to Parents for Sex Info

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HPV Vaccine is FDA Approved - What's Next?

Yesterday the FDA gave final approval for Gardasil, Merck's new HPV vaccine that promises to significantly reduce the risk of cervix cancer, precancerous lesions of the cervix, and genital warts.

Here are the facts and answers to FAQs as I see them:

• The vaccine is currently approved for use in girls and women ages 9 to 26.
• Women, and the parents of girls should consider the vaccine before sexual activity is initiated, but it may be given to any age-appropriate woman regardless of prior HPV exposure because it offers protection for four-subtypes of HPV virus.
• The vaccine offered 100% protection against high-grade precancerous lesions, cervical cancer, and genital warts in women who had no prior HPV exposure in pre-release studies.
• The vaccine will not prevent progression or expression of HPV-related disease that is caused by a virus type that a woman has already been exposed to.
• The usefulness in older women, and in men and boys is currently being studied. At this point, they are not candidates for vaccination.
• The vaccine will not reduce the importance of regular gyn exams and Pap smears.
  
• The vaccine schedule consists of three doses, given over a six-month period.
• It is not recommended for pregnant women, or for women who are trying for a pregnancy during the vaccination period.
• The vaccine is produced from highly-purified "virus-like particles" that are part of a protein that's found in the wall of HPV. There is no active or intact virus in the vaccine; it is made from yeast that has been genetically modified to produce the particles.
• Follow-up studies in more than 20,000 women for up to four years indicates that the vaccine is extremely safe. Adverse reactions and side-effects are very rare.
• The vaccine is $120 per dose, so the series costs $360. Insurance coverage for the vaccine is yet to be worked out, but it should be covered as are other preventive care measures.
• Details may be found in the Patient Education Pamphlet.

The opportunity to significantly lower the amount of HPV-related disease is HUGE, and I think this is great news for women and for parents of young women or women-to-be. I know that I am going to recommend in favor of vaccination for my patients, their daughters, and, specifically, for my daughter.

I hope that the third-party payors will quickly pave the way for this to become universally available. And, most of all, I hope that the current government, with its sometimes anti-women, anti-progress politics, won't try to stall or block the availability of public funding for the large numbers of uninsured women who probably need it most. We'll see......

RW, MD

Related Topics: WebMD Video: Cervical Cancer - Hear from Experts and Patients, Cervical Cancer Vaccine Approved

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Mucous describes Mucus

This is just a playful little spelling lesson post...

I notice, almost daily, that many of our posters on the WebMD message boards misspell (or misuse) the words mucus and mucous when they're describing the uniquely feminine qualities of cervical and vaginal secretions. There's so much variation in the posts, everyone gets confused. (And, I have to admit, it took a medical education and a specialty certification before I finally got the terms right!)

Here's how they should be used:

• Mucus is a noun - it's the stuff we're always talking about.

• Mucous is an adjective that describes the qualities of mucus.

• Mucas isn't a word.

Hope that helps!

RW, MD

Related Topics: Pregnancy Calendar, Getting Pregnant

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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?

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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

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