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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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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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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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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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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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?

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Even though I am not adverse to controversy (I like spicy arguments now and again…”), I really wanted to avoid abortion and emergency contraception for awhile. But, I just can’t…

Last weekend I was involved in a case that was an opportunity for further reflection. I performed a cesarean section on a newly-turned fourteen-year-old. Unfortunately, her pregnancy was the result of a rape by a “family friend” when she was 13 years old.

In this particular case, the rape was not revealed until well after the time that emergency contraception was an option. And, abortion was never an option.

But, as I sat with this patient and her family over the weekend and helped them deal with the unarguably far-reaching consequences of life’s events, which included major surgery, adoption vs. parenting, etc., etc., I couldn’t help but reflect on the following:

What if I were in the emergency room responding to a similar case of the rape of a thirteen year-old? The gathering of evidence and the recommendations around STD prevention are fairly straightforward.

But what about the potential of pregnancy and the choice to offer her emergency contraception? I find myself wondering whether any physician, no matter his or her beliefs about abortion or the mode of action of “emergency contraception” or practice setting, would or could ethically withhold the choice to take the “morning after pill” under such circumstances. I would like to believe that no physician would put his or her “morals” in the path of such a patient choice. It seems clear to me that at least offering the prescription is the right thing to do, and I believe that most, if not all of the physicians with whom I have worked would offer that choice.

I am left feeling kind of numb with the whole conversation about the legalities of abortion and emergency conversation. I feel that legislating what patients may or may not do, or what doctors or clinics or hospitals must or must not do is polarizing, and only gets in the way of doing the right things for patients. I’m tired of arguing.

RW, MD

Related Topics: Syphillis Rising in the US, Protecting Your Child from Sex Abuse

Technorati Tags: birth control, morning after pill, sexual abuse, medical ethics

I recently wrote a blog entry about new guidelines for managing abnormal Pap smears in young women.

At the end of the ACOG Committee Opinion, there’s an interesting aside that deserves comment: the fine line about confidentiality issues and informed consent when evaluating and treating adolescents with these problems.

This is an issue that has come up more than once in our practice. Frequently, young women have Paps done as part of STD screening, or in order to get prescriptions for birth control pills. When their Paps occasionally come back abnormal, they’re called in for further work-up and possible treatment.

Historically, adolescents are allowed by state laws to obtain contraception and STD screening without parental consent. But, when a problem is uncovered, and further testing and treatment are necessary, the ethical and consent issues become cloudy.

For example, we recently had a 17-year-old woman with an abnormal Pap smear. When she came back for colposcopy, she insisted that the workup be kept confidential or she would not undergo the evaluation. We went ahead and did the evaluation without parental notification or consent under the assumption that we were managing STD. But, when a high-grade lesion that required excisional biopsy was uncovered, some of us questioned the wisdom of proceeding with the procedure without parental involvement.

This was a tough case. The patient clearly did not want her parents to know anything about this. But, we were recommending therapy with potential cervix-damaging consequences, and one could argue that a 17-year-old shouldn’t be responsible for such decisions on her own. And there were insurance issues here as well: her insurance coverage was as a minor under her parents’ policy, and we couldn’t guarantee that billing confidentiality could be maintained. She again threatened to avoid further care for her problem if that involved notifying her parents. So, we were faced with several ethical dilemmas…

As a patient advocate, I can make the argument that this condition is the result of STD exposure and that the patient should have the right to make adult decisions about adult problems. But as a parent, I would expect to be notified if my minor child needed a surgical procedure, especially if it had such far-reaching consequences as potentially threatening her fertility, or my pocketbook!

The obvious superficial best choice here would be for the adolescent to come out about this to her parents and receive their support, despite the consequences. But, that’s not always easy in all circumstances. And, it’s surely not easy being caught in these situations where we’re trying to provide the best overall support for our patients.

RW, MD

Related Topics: New Healthcare for Teens, Teens Look to Parents for Sex Info

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With the birth of Tom Cruise and Katie Holmes’ baby girl, Suri, it’s worth taking a look at the controversy about their intention to have a “silent birth.” According to their religion, the birth and the immediate postpartum period should be conducted as silently as possible in order to provide the “best possible environment for the birthing mother and her new baby.” I’m not sure why this upset anyone. That sounds like noble intent, to me.

I am not very familiar with Scientology and its tenets, but I do know that the idea of welcoming a newborn into the world in a calm, quiet, peaceful environment seems intuitively appropriate to me. I’m familiar with similar practices employed by my patients over the years, like the “Leboyer Method,” which was popularized by the French obstetrician Frederick Leboyer in his classic Birth Without Violence. The practice of “gentle birth” appeals to many segments of the world’s population without regard to religious practices.

It appears there’s a misconception that’s been spread in the media that women are discouraged from making a sound during birth, and that’s understandably produced an uproar among womens’ advocates and birth experts. But, all the accounts I’ve read of “silent” births indicate that womens’ choices are supported in the process including birth location, position, provider / birth attendant choice, anesthesia options, and even noise-making! And, I don’t think that Tom’s appropriately paternalistic intentions to support his idea of a nurturing environment for his beloved newborn necessarily infringe upon Katie’s birth choice and experience…

So, I ask, “what’s wrong with a little silence?” Surely no one would argue that silence might be more welcoming to a newborn’s acute senses than a blaring TV or Nintendo – whether it has long-lasting effects or not. I don’t think it takes medical research to make that case. And, to put it in perspective: why not cut Tom and Katie a little slack, if this is the experience they wanted for themselves and their family? This is, after all, America: the land of “Cesarean Birth on Maternal Demand” and elective newborn circumcision – neither of which is supported by sound medical research.

RW, MD

Related Topics: Elective C-Section Under Spotlight, Few Would Choose Their Babies’ Sex

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I know this isn’t about pregnancy, but every now and then I feel the need to comment on noteworthy news for the vast majority of women who are not pregnant…

This month, the American College of Obstetricians and Gynecologists released a Committee Opinion on the Evaluation and Management of Abnormal Cervical Cytology and Histology in the Adolescent. In plain English, that means that there are new guidelines about how to deal with abnormal Pap smears and cervix biopsies in young women.

The new guidelines have come about because of improved understanding of the natural history and cancer-causing potential of human papilloma virus (HPV), and because we have improved Pap smears (liquid-based) and high-risk HPV DNA testing available to us now. The net result is that we are finally able to say that most HPV-related problems in young women are unlikely to cause cancer, and we are comfortable using the new tools to follow the abnormalities conservatively rather than treat them aggressively unnecessarily.

This is good news, because most HPV infections and their resulting abnormalities will resolve on their own without treatment. The treatments (cryotherapy, laser, and LEEP) are known to increase the risk of damage to the cervix, and it seems prudent to limit these procedures in the relatively young.

The bottom line here is that if you or your young daughter’s Pap smear is abnormal, it is now reasonable to take a more conservative approach to managing these lesions without a fear of cancer developing. Such observation requires good compliance with follow-up, however, and only well-informed, reliable young women should take advantage of these relaxed guidelines.

RW, MD

Related Topics: WebMD Video: Cervical Cancer Vaccine, New Guidelines for Cancer Screening

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