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.

Forget the Oscars (well, not entirely: Go, Juno, go!); the movie I really want to see is A Walk To Beautiful. Having already won several awards at film festivals around the world, the film follows five courageous women as they travel to the Addis Ababa Fistula Hospital in Ethiopa to find a cure for the obstetric fistulas they suffer from. Fistulas are an opening between the vagina and rectum or the vagina and urethrea which occurs after days and days of obstructed labor. In developed countries around the world, fistulas have become a thing of the past since the advent of cesarean birth (the last U.S. fistula hospital closed its doors in 1895), but in developing countries around the world, it’s still a very grim reality. Incontinent, with either feces or urine dripping from their vaginas, women with fistulas are often shunned by their communities, ostracized and forced to live lives of isolation. The cure for fistulas is a simple surgical procedure, but with access to modern health care often hundreds of miles away, the cure might as well exist on another continent. Just check out some of these facts:

• For every woman who dies from pregnancy-related complications, 20 women survive but experience terrible injuries and disabilities.
• In Ethiopia, there are 59 OB/GYNs and 1,000 midwives for a population of 77 million.
• One woman dies from pregnancy-related complications every minute worldwide; 95% of them live in Africa and Asia.
• More than 99% of The Fistula Hospital patients are illiterate. (The hospital teaches all patients the Amharic Fideles and the Oromiyffa alphabets.)
• Number of patients treated at the Addis Ababa Fistula Hospital every year: 1,200
• Number of obstetric fistula cases occurring in Ethiopia alone each year: 9,000
• Number of new obstetric fistula cases resulting from childbirth occurring worldwide each year: 100,000
• Number of new obstetric fistula cases resulting from childbirth occurring in the U.S. each year: 0.

The movie is playing at the Quad Cinemas in New York City right now, and has recently been extended through February 28th. I’m hoping to see it on Wed., and I’ll certainly write a review afterwards. Good stuff.

(Go Juno, go!)

I got a phone call last night from a good friend from college, who has just recently been diagnosed with an ovarian cyst, and had been told by her doctor not to worry too much about it and was prescribed birth-control pills to help manage the symptoms. She wanted a second opinion, and I told her what I knew about ovarian cysts (i.e. that they’re very common, usually benign, usually do not affect fertility, and usually spontaneously resolve in a few months without incident), but I did promise that I’d do some more research on the subject for her. So here you go: more than you probably ever wanted to know about ovarian cysts!

An ovarian cyst is a fluid-filled sac that forms on the ovary. The majority of ovarian cysts are benign, and are classified as either functional or organic. We’ll start with functional cysts, because they are simpler and easier to understand.

Functional cysts are fluid-filled sacs which most often form during a normal menstrual cycle—either during the follicular phase or the luteal phase. Follicular cysts are more common and are often undiagnosed because they are usually asymptomatic. During the follicular phase of the menstrual cycle, the follicle ripens while the egg matures and becomes a small, fluid-filled sac in the process. During normal ovulation, when the egg is released the sac breaks open, the fluid is released along with the egg, and the remnants of the sac are eventually re-absorbed. If for some reason the egg is not released (i.e. there is no ovulation), the ripened follicle can remain as a cyst, and may continue to grow through the next menstrual cycle. Follicular cysts can occassionally grow quite large, and the risk of torsion or rupture increases the larger the cyst becomes. However, the majority of follicular cysts usually spontaneously disappear within one to three months.

Luteal ovarian cysts, or corpus luteum cysts, occur during the second half of the menstrual cycle, after ovulation has occurred. Once the follicle has ruptured and the egg has been released, the remaining follicle sac becomes the corpus luteum, which produces progesterone and maintains the endometrial lining of the uterus. If the egg is not fertilized and pregnancy does not occur, the corpus luteum normally disappears through a process called luteolysis, which occurs with the onset of menses. In some cases, though, the corpus luteum does not disappear, and instead seals off after ovulation, fills with fluid and forms a cyst. Luteal cysts are less common than follicular cysts and usually disappear on their own within a few weeks. However, they can sometimes grow up to four inches and may cause bleeding, torsion, or pain.

If a small blood vessel ruptures inside a functional cyst, the cyst fills with blood instead of clear fluid, and is then called a hemorrhagic cyst. However, like follicular and luteal cysts, hemorrhagic cysts rarely rupture, are often self-limiting, and will most likely spontaneously resolve on their own.

Organic cysts are the second type of ovarian cyst, and are much less common than functional cysts. They’re referred to as complex cycts because of how they appear on ultrasound, and may contain blood, serous or solid material inside them. The type of cyst that forms depends on the type of ovarian tissue the cyst arises from. “Mucinous or serous cysts arise from mucinous or secretory ovarian glandular cells and can become very large, though they usually grow slowly.” (Schuiling & Likis, 2006). Another type of organic cyst known as a dermoid cyst arises from ovarian germ cells. Because germ cells have the capability of forming any material in the body, dermoid cysts sometimes contain unusual substances such as hair cells, skin cells, bone cells, tooth enamel or other body material. Dermoid cysts tend to grow rapidly and can become very large. They are rarely malignant, however, because they don’t spontaneously regress and there is some (albeit small) chance of malignancy, dermoid cysts are most often surgically removed . Another kind of organic cyst is known as a cystadenoma, which forms in the stromal tissue on the outside of the ovary, and can also grow quite large and cause a fair amount of pain.

Ovarian cysts can also be caused by other illnesses. Endometrial tissue begins to grow outside the uterus in women with endometriosis, and can sometimes attach itself to the ovary, forming an endometrioma, which is a solid cyst. Women with polycystic ovarian syndrome (PCOS) form multiple functional cysts within their ovaries from repetitive anovulatory cycles, and are often infertile. While neither of these kinds of cysts are malignant, managing these types of cysts requires dealing with the underlying etiology—either endometriosis or PCOS—and these cysts usually do not resolve on their own without assistance.

Because ovarian cysts are usually asymptomatic, many women have them without realizing that they do, and they often resolve on their own without the woman even being aware. Otherwise, the woman may experience pressure or fullness in the abdomen, pain during intercourse, persistent low-back ache, urinary frequency, chronic pelvic pain or pain during menstruation. Ovarian cysts are sometimes detected during a routine pelvic exam if a large mass or fullness is felt around the ovaries. However, diagnosis is most often made by ultrasound (either abdominal or transvaginal ultrasound), and management depends in part on the size of the cyst.

For most functional cysts, nothing needs to be done. Simple cysts don’t require therapy unless they’re larger than 8 cms, rupture or lead to ovarian torsion. The “watch and wait” approach is most often used, since these cysts usually spontaneously resolve on their own. If there is minor pain associated with the cyst, medication like Motrin or Tylenol is usually enough to manage the pain while waiting for the cyst to disappear. Follow-up ultrasounds at 1-3 months after diagnoses are sometimes performed, but aren’t mandatory unless the symptoms persist or worsen. If the cyst is between 5-8 cm, repeat visits to your doctor or midwife may be needed to follow the growth of the cyst. Surgery may be required to drain and remove larger cysts (anything greater than 8 cm), and is usually done either through laparoscopy or laparotomy. Other tests, such as a blood test to check for CA-125, a tumor marker which can indicate malignant growth, may also be performed for larger cysts just to rule out cancer. Oral contraceptive pills can be prescribed to help reduce the likelihood of repeat cyst formation, and may be especially helpful in women who keep having ovarian cysts. Since ovulation and the ripening of a follicle are often the causes of functional cyst formation, birth control prevents this from happening by preventing ovulation.

Organic cysts are generally more complex and usually require medical treatment. An MRI or cat-scan may be used in addition to ultrasound in order to diagnose the exact type of cyst (dermoid, cystadenoma, endomerioma etc.) The tumor marker CA-125 will most likely be checked to rule out cancer, and larger cysts greater than 8 cm will most likely be removed via surgery.

Warning signs for the rupture of an ovarian cyst include nausea and vomiting, fever, sudden, severe abdominal pain, fainting, dizziness, weakness or rapid breathing. In the case of very large cysts, rupture can be quite dangerous, so emergency care should be sought immediately if any of the warning signs appear. Otherwise, as in the case of my friend, who has some type of functional cyst by the sound of it, I’d agree with her doctor’s assessment that she shouldn’t worry too much about it. The cysts will probably go away on their own, and using oral contraceptives will make the likelihood of future cyst formation very, very slim.

References and further resources:

Shuiling & Likis (2006) Chapter 22: Benign Gynecologic Conditions. Women’s Gynecologic Health, pp. 584-587, Boston, MA: Jones and Bartlett.

Varney, H. et. al. (2004) Chapter 14: Common Diagnoses in Women’s Gynecological Health. Varney’s Midwifery: Fourth Edition, p. 406, Boston, MA: Jones and Bartlett.

Women’s Health.gov: Ovarian Cysts

Emedicine: Ovarian Cysts

So, I’m back in the blogosphere again, and realizing that I’ve been missing a lot of important news by taking a vacation for a few months. Here’s a quick overview of some of the stories I’ve found most pressing (and/or impressive) lately, even though some of these stories are old news by blog standards, and many other people have already done a much better job at covering them than I have.

First, Verizon Wireless, the cellphone megagiant, has gotten itself into a heap of trouble by initially refusing to allow NARAL Pro-Choice America to host a text messaging service on its network. Verizon initially claimedthat company policy allows it to refuse “highly controversial” and potentially “unsavory” messages from being distributed on its network. NARAL quickly shot back with an action alert and Verizon was flooded with thousands of e-mails and text messages from angry subscribers, and several anti-censorship groups also joined the fray. Quickly realizing it had made a huge mistake (especially when it discovered that other cellphone networks like Sprint and AT&T had approved the NARAL text messaging service without a whiff of protest), Verizon reversed its position, allowing the NARAL text service to go forward, and issued a statement in the press, but NARAL is still hounding Verizon to put its new public policy in writing. Interstingly, since the issue dealt with text messaging and shortcodes, the story was picked up not only by pro-choice and anti-censorship news carriers and blogs, but by sites like Ars Technica and Slashdot.

Sticking to the technology theme, the website Facebook recently started banning pictures of women breastfeeding from user accounts, and in some instances has banned specific users altogether (for example, Karen Speed from Australia, who has chronicled the entire event on her blog, One Small Step for Breastfeeding). Facebook banned certain pictures on account of their “obscene content” and asserted its right to remove pictures as a violation of its terms of use policy, but as the Sydney Morning Herald points out, it’s not exactly clear what constitues an “exposed breast”, which is the specific violation, and Facebook hasn’t provided any further. clarification. Right. So, breastfeeding is obscene, and women aren’t allowed to post their own pictures of themselves breastfeeding on their own facebook accounts. If this bothers you as much as it bothered me, go join the new facebook group entitled Hey, Facebook, breastfeeding is not obscene!

In other news, a 43 year old Russian woman has recently given birth to a 17 lb. baby, her 12th baby to date. Wow!!

Finally, this is a quick reminder to local folks that the 5th annual Miles for Midwives will be occurring this weekend, Oct. 6th, at Prospect Park. The 5K run/walk helps to raise awareness for midwifery, as well as raise money for the ACNM local NYC chapter, and Friends of the Birth Center. My beloved boy and I will both be there, of course, running and sweating in the sunshine. Race time is 10:00 am, rain or shine. If you’re interested in joining the race, you can register at Active.com.

Finally, the long-awaited SUNY Downstate Gala will be occurring this coming weekend, celebrating 75 years of continuous midwifery education. SUNY Downstate is actually the oldest and longest running midwifery program in the country, and is commerorating the event by a day-long educational symposium featuring speakers such as well-known author Barbara Katz Rothman and keynote speaker Joyce Thompson, CNM, followed by a dinner-dance. Sounds amazing! Go Downstate!

People ask me a lot of questions, and unfortunately I rarely get a chance to post very many of them here. However, I thought this was a particularly good one, and might be useful to other readers as well, so here we go:

“I came across your website when I was google searching the words “Ina May” and hyperthyroidism. Reading a bit on your blog, I saw that you did a monstrous report on the condition. I have a ten month old baby girl (my first) and was recently diagnosed with hyperthyroidism (my TSH was .004) but have not yet been to an endocrinologist. My physician put me on atenolol, but I am still breastfeeding so I’m not taking it. Anyway, I was wondering what your report was about, and if you might have any suggestions that you could share. Many thanks in advance.”

Funny that you should ask about this, because we actually had our lecture on thyroid conditions during pregnancy today. My earlier report was on different thryoid conditions which are often seen during primary care of women (not necessarily during pregnancy), although today’s lecture focused only on pregnancy. My first suggestion would be to go to an endocrinologist as soon as possible. There are many different causes of hyperthyroidism, the most common cause being Grave’s Disease, which is an autoimmune disorder caused by thyroid stimulating antibodies. However, there are many other different causes of hyperthyroidism, running the gamut from pituitary tumors (very rare) to iodine-induced hyperthyroidism. This is why you’ll really need an endocrinologist to help figure all of this out; it’s complicated stuff, with many different etiologies.

Another thing to think about is when your symptoms first began. Was it before your pregnancy, during your pregnancy, or has it been only during the postpartum period? If only during the postpartum period, there might be another cause for the hyperthyroidism: postpartum thyroid dysfunction (also called lymphocytic thyroiditis or postpartum thyroiditis), which occurs in about 5-10% of all pregnancies. With this disorder, usually hyperthyroidism develops first, about 2-3 months postpartum, and will continue for up to 4 months postpartum, followed by a hypothyroid phase lasting 1-3 months. In 70-90% of all cases, this will usually resolve spontaneously without treatment, usually within 6 months. However, 10-30% of women with postpartum thyroiditis may have permanent hypothyroidism, so again, it would be a good idea to have an endocrinologist following this in order to determine the true cause of your hyperthyroidism, and whether it will resolve or not.

Treatments for hyperthyroidism usually include either PTU (Propylthiouricil) or Methimazole (Tapazole), both of which interfere with the synthesis of thyroid hormones by preventing iodine uptake. Both of these medications can be used during pregnancy AND are safe for breastfeeding. Atenolol (a beta blocker) was also listed in our lecture as one of the drugs used to help control the severe hypermetabolic symptoms of hyperthyroidism, such as tachycardia (fast pulse), tremors, palpitations and heat intolerance. Beta blockers are actually the treatment of choice for thyroiditis, and are safe to use during pregnancy. There is no contraindications to using beta blockers while breastfeeding. I just visited the website forum of Dr. Thomas Hale, one of the leading experts on pharmacology during breastfeeding, and looked up Atenolol. In this post, as you can see, one woman was concerned about the possibility of a baby having hypoglycemia after breastfeeding from a mother who was taking atenolol, but it seems that while atenolol might cause hypoglycemia in adults, he didn’t think it was present in breastmilk in suffiicient quantities to cause hypoglycemia in an infant:

I spoke with a Pediatric Cardiologist whom I greatly respect. He assured me that he’s used beta blockers and atenolol many times in pediatric patients and has yet to see hypoglycemia.It is true that in adult diabetics, it may induce hypoglycemia, but I’m reassured that his probably does not occur in infants, particularly from minor exposure via milk.He also told me that infants are apparently less sensitive to beta blockers and that even higher doses are sometimes required to be effective.So I’d look for something else causing hypoglycemia in your infants.

The thread on antihypertensives makes it very clear that beta blockers are fine during breastfeeding, so I think you would be okay taking atenolol and nursing at the same time. Medications in Mother’s Milk might be a really good resource for you.

Other treatment options for hyperthyroidism, if that is indeed what you have (as opposed to postpartum thyroiditis), include radioactive iodine treatment or surgery (partial thyroidectomy), but again, these are options best discussed with your endocriniologist.

I’m including a few resources here in case you want to look any of this stuff up yourself. These were some of the references from my presentation. Hope this helps!

Smeltzer, S., Bare, B. (2000) Metaboloic and Endocrine Function; Assessment and Management of Patient with Endocrine Disorders. Brunner and Suddarth’s Textbook of Medical-Surgical Nursing, Lippincott, Williams and Wilkins: New York.

Reid, J., & Wheeler, S. (2005) Hyperthyroidism: Diagnosis and Treatment. American Family Physician, 72(4): 623-630.

American Association of Clinical Endocrinologists. (2002). Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Hyperthyroidism and Hypothyroidism. Endocrine Practice, 8(6):458-469.

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.

This just arrived in my inbox, moments ago. I can’t find a single news story written about this yet, in any of the papers. Is it really possible for a blog to beat the newspapers when it comes to a story? Neato!

We did it!
At 9:20 a.m. today, the FDA approved over-the-counter access to the “morning-after” pill!

Dear *******,

Thanks to the letters, petitions, and support from people like you, the FDA finally overcame the political pressure from the White House, Congress, and anti-choice lobbyists, and approved the morning-after pill for over-the-counter sales.

Medical experts and scientists at the FDA have asserted for years that the morning-after pill - which can prevent an unintended pregnancy if taken within 72 hours after sex - should be available without a prescription. It’s safe, it’s effective, and it’s a commonsense way for women to prevent unintended pregnancy.

Thank you again for helping achieve this victory for women - your action does make a difference.

My best,

Nancy Keenan
President
NARAL Pro-Choice America

Wow, is this for real?? HOORAY!!! It only took two years too long, but let’s hear it for strong scientific evidence finally winning out in the end. I’ll update with more articles on this as they are written, because I’m sure this will be in the news today. This calls for a real celebration, though, and a thankful prayer for a return (even if, perhaps, momentary and fleeting) to rational, evidence-based thinking on the part of our government. I’m thrilled! Just got back from a long shift at work, and am off to bed, but with news like this, I’m off to bed HAPPY.

(I really hope I don’t wake up later today and find out that this was all a dream. Someone pinch me, please.)

ADDENDUM:

This news is now in The New York Times, so it must be true. Wheeee!

Feministing maps out the conservative response to today’s news, with unabashed glee.

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.