Category Archives: Family Planning

More on the Ortho Evra Patch and the FDA

The NY Times revealed on Sunday that Ortho, in reporting the results of a 1999 clinical trial of the contraceptive patch to the FDA, used a “correction factor” to adjust down the estrogen exposure in the patch by about 40%.

This adjustment was never part of the study protocol, a plan filed with the F.D.A…The company mentioned its decision to use the “correction factor” only once in a 435-page report filed with the F.D.A., and then only in a complex mathematical formula. When the study was published in 2002, there was no reference to the alteration.

The FDA recently updated the package labeling for the Patch to reflect the higher estrogen dosing and to warn users of the potential for blood clots from Patch. Ortho is now facing lawsuits from women who experienced blood clots they claim are related to the increased estrogen dose in the Patch.

According to the Times, the drug maker is attempting to block the suits, claiming that because the FDA approved the patch, Ortho should be immune to any lawsuits stemming from complications related to its use. It’s an argument that has made before, with recent success in favor of medical device makers.

If that’s the case, then doctors should be immune to lawsuits, since the Medical Board licenced us, right?

Somehow, I don’t think that’s gonna’ happen.
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My thoughts on the Patch

Thoughts on the Contraceptive Patch and Blood Clot Risks

The FDA has updated the labelingfor the Ortho Evra Patch to warn users that the patch may have a higher risk of blood clots than other lower dose hormonal contraceptives.This is the second major labeling change since the patch was approved in 2001. The first change came in 2005, when it was found that the patch exposed women to increased levels of estrogen compared to low dose pills. This latest labeling change includes data from two recent studies that found a two-fold increase in thrombo-embolic events associated with the patch (as well as a third study that found no increased risk).

Although a bit late, I believe that the FDA is doing the right thing. Women who use the patch need to be informed that they are taking a higher dose estrogen product, and that higher doses may cause more clots.

It’s called informed choice.

A Little Background

In retrospect, I was not surprised to find out in 2005 that the patch has higher estrogen exposure than most pills. Breast tenderness was reported in the clinical trials in around a fifth of patch users, compared with less than 10% of pill users. And I had seen the same complaints from my patients who were using the patch.

In fact, shortly after the patch came on the market, I had begun to wonder about the estrogen levels and how they compared to the pill. Unfortunately, neither the package insert nor the contraceptive literature was helpful – no one source had comparative data. I remember asking the Ortho rep if he could tell me how the estrogen dose in the patch compared with a 35 microgram pill. The answer was something like “It’s like comparing apples and oranges. The trans-dermal dose has a different metabolism, so you can’t compare the dose itself.” Which is technically true.

But what you can compare is total estrogen exposure, something pharmacokinetics experts call “the area under the curve” or AUC. This kind of comparison was published in 2005 in a study comparing the patch to the vaginal contraceptive ring and a 30 ug (standard dose) pill.

Lo and behold, the AUC for patch users was 3.4 times that of ring users and 60% higher than in pill users! Now all that breast tenderness made sense. (This was the kind of data that prompted the Ortho Evra label change in 2005.)

Here was my thinking, simplistic though it may be. If EE levels are 60% higher on the patch than the 30 ug pill, doesn’t that mean the patch is equivalent to a 48 ug pill? And didn’t we long ago stop prescribing 50 ug pills because the clot risk was too high? So if I wasn’t routinely offering my patients the 50 ug pill as a first line method, why would I routinely prescribe the patch as a first line method?

Just because the patch isn’t first line, does not mean it has no place in our birth control armamentarium. 

What kind of women might want to use the patch? Well, some women take other meds that interfere with the effectiveness of birth control pills. Topamax is the most common such drug. For these women, the higher estrogen levels in the patch may be enough to give them the protection they need against pregnancy.

Another candidate for the patch is the woman who can’t remember to take a pill and is unable to use a barrier or IUD. Such a woman will often be willing to accept the higher estrogen dose in return for protection against pregnancy. This is not an unreasonable trade-off if you have had an unplanned pregnancy due to missed pills. However, is you want ease of use and compliance, you could also use the Nuva Ring, which comes at a much lower dose (but the clotting risks have not been compared). So that’s your choice.

The CME Response

I am getting a bit perturbed with all the posturing and spinning about the patch out there in CME land. All the thought leaders with conflict disclosure lists longer than my CV, who are weighing in on the clot data. Arguing that the studies are not conclusive, that one study used medical chart data and the other insurance claims data, etc., etc. Some are insinuating that the media is over-hyping the risks of the Patch, despite what seems to me to be quite responsible reporting on this issue.

C’mon guys. Most of you have spent the last 4 decades convincing us all that pills are safer than they were years ago, largely because the estrogen dose is lower. Don’t ask us to ignore those risks now.

More questions

I keep asking myself – Could Ortho and the FDA not have known this data? Didn’t anyone ask how the patch and the pill compare? If they were seeing breast tenderness and nausea at a higher than expected rate in patch vs. pill users in the clinical trial, didn’t they wonder what estrogen levels were?

So I went back and read the initial FDA review of the patch to see what sort of data was presented in this regard. Turns out the reviewers did note that weekly estrogen exposure was higher in patch than pill users, and directly related this data to the two pulmonary emboli reported in clinical trials.

There were two Pulmonary Emboli reported during the trial in patch users, one of which Ortho tried to discount since there was a protocol violation. The FDA’s reviewer disagreed and insisted that both cases be counted. The reviewer also recommended that the package insert reflect a concern that the patch has an increased risk for venous thromboembolism. In the end, the package insert merely stated that “it is unknown if the risk of venous thromboembolism with Ortho Evra is different than that for oral contraceptive users.”

Now what the FDA and Ortho could have done was to approve the patch as a niche method with known higher estrogen levels which, on balance, could be seen as an acceptable price to pay for the ease of use and compliance. Instead it was approved and marketed it as a first line method for any woman, with no discussion as to how estrogen levels might compare to other products already available out there. And I think that was just wrong.

Compare this to how Ortho advertizes their pill Ortho Tricyclen lo – “Do you want a high level of effectiveness and a low level of hormones?” it asks us on their web site. As if any of these methods have low hormones – they all work because their hormone levels are supra-physiological. But Ortho’s marketing folks know that women believe lower hormone levels are better. Why? Because that’s what we’ve been telling them for years!

The right way to label the patch

So, to make a very long story short, it took us 7 years to get here, but the FDA prodcut labeling for Ortho Evra is finally appropriate.

And Ortho’s website now states, “The patch is a not for everyone”. And that’s right. The patch is a niche method. It absolutely should remain on the market for those women who for whatever reason, can’t or don’t want other methods and are willing to accept a slightly higher clot risk in return for the benefit of effective contraception. But it’s not for everyone.

So, what is the risk?

Actually, despite everything I’ve just said, the risk for getting a blood clot on either the pill or the patch is quite low. How low? Well, that depends on what you think the background risk for DVT is in the general female population. For argument’s sake, let’s say that risk is 5 per 100,000 women per year. (A commonly quoted number, represented by that little red dot at the bottom right of the grid of 10,000 women).

The risk with oral contraceptives would be about 20 per 100,000 and the risk with the patch about 40 per 100,000 women per year.

Now, compare that to the risk of a DVT in pregnancy – about 16 per 10,000.
These are very low risks, aren’t they?

But multiply them by the millions of women using a method for decades of their life, and you can see that the differences in risk can lead to significant increases in population rates of DVT. And, if you had a choice between two birth control methods that were equally effective for you, you might want to choose the one with a lower risk. On the other hand, if the method with the higher risk was more effective for you, you might be willing to accept the increased risk in return for that efficacy.

As I said, it’s all about informed choice.
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FDA Warnings on Nonoxynol-9 Re-Define Sponge Worthiness

Elaine’s date tries to convince her that he is “Sponge-Worthy”
The FDA has issued a new ruling requiring manufacturers of contraceptive and spermicidal products containing Nonoxynol-9 to warn users that Nonoxynol-9 does not protect against HIV or other STD’s. Labels must also warn that Nonoxynol-9 can irritate the vagina and rectum, which may increase the risk of contracting HIV/AIDS from an infected partner.

Nonoxyl-9 is the active ingredient in the contraceptive sponge. It’s also found in spermacidal jellies used with diaphragms and cervical caps, and in contraceptive inerts, foam and vaginal film.

Nonoxynol-9 is a surfactant, and acts to disrupt sperm membranes, thus preventing pregnancy. Contraceptive efficacy of N-9 containing spermicides ranges from 70% if used alone to 80-90% when used with a diaphragm. Advantages include absence of hormones and easy reversibility. The disadvantages are that they are less effective than hormonal methods, can cause irritation and can increase HIV transmission if your partner is HIV-infected.

So before you dip into your sponge stock or take out your diaphragm for a guy, better make sure he’s truly worthy and does not carry the HIV virus. If you’re not sure, forget the sponge or diaphragm and use a condom.

TBTAM’s Rules for Spermicide Use

  1. If you are at risk for HIV or if your partner’s HIV status is unknown to you, don’t use Nonoxynol-9 containing contraceptives. Use a non-spermicidal lubricated condom. If you want additional protection against pregnancy beyond that which condoms provide, look towards additional methods that don’t entail spermicide use, like the oral contraceptive.

  2. If you are at low risk for HIV infection, and especially if you know that your partner is HIV negative, go ahead and use whatever contraceptive works best for you, including spermicides, diaphragms and sponges.

  3. The best way to protect yourself against HIV infection is to limit your number of sexual partners, or as TBTAM has said again and again – Save sex for those you love. But since even someone you love could have HIV, both of you should get that HIV test before you stop using a condom or use spermicides.

The Road to the Ruing

We’ve known for some time that Nonoxynol-9 use can increase HIV transmission, from studies of sex-workers in Thailand and Africa, who were found to acquire HIV more often when they used Nonoxynol-9 spermacides along with condoms, compared to their counterparts who used just condoms.

In 2002, the CDC issued a warning against the use of Nonoxynol-9 for HIV or STD prevention, and advised against using spermicidal lubricated condoms for HIV prevention. In response, over a dozen condom manufacturers, including Planned Parenthood, stopped adding spermicides to their products, as did makers of personal lubricants.

But at the FDA, the issue became politicized, since it involved labeling on condoms.

Right-wing advocates of abstinence wanted the label to say that condoms don’t protect against AIDS. AIDS Advocacy Groups wanted to be sure that the labeling did not discourage condom use. Women’s groups were concerned that the warning against spermicides might be applied too broadly, causing women who were at low to no risk of HIV to turn away from effective contraception. Also at the table were the condom manufacturers, some of whom continued to manufacture spermicide-lubricated condoms on the grounds that these condoms are appropriate for couples without HIV. And, I suspect, the instability of the FDA leadership over recent years didn’t help the matter…

In 2003, the GAO, under pressure from the right wing lobbyists, issued a statement against the FDA, urging them to move forward on the labeling change. Four years later, the ruling is finally final.

The FDA warning goes beyond the 2000 CDC message to address the widespread use of Nonoxyl-9 in contraceptives, and to correct any remaining mis-perception that these spermicides protect against HIV.

The ruling also contains wording for condom labels that states that their consistent use greatly reduces, but does not eliminate, the risk of catching or spreading HIV. A nice compromise, I think, on that issue.
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The full FDA Ruling is posted on the FDA Website
Great info on Nonoxynol-9 from IBIS Reproductive Health

Cervical Cancer and Birth Control PIlls

A recent meta-analysis has confirmed that use of birth control pills slightly increases the risk of cervical cancer. But before you stop your pills, take a deep breath, relax and read further.

Because the risk is really small. How small? Well, if you live in a developed country (meaning you have access to Pap smears), use of the pill for 10 years increases your chance of having cervical cancer from 3.8 per 1,000 to 4.5 per 1,000.

Remember that the real cause of cervical cancer is not birth control pills. It’s infection with the Human Papilloma Virus (HPV).

But estrogen metabolites of the pill may make your DNA more susceptible to changes induced by the HPV virus. The pill can also make the glands of the cervix more exposed to infection by the HPV virus. The other big factor may be that women taking the pill may use condoms less frequently, thus making them more likely to get HPV.

The good news is that once you stop the pill, the increased risk of cervical cancer goes away. That means that when you get older and don’t need birth control, you won’t be paying the price for your decision to use pills when you needed them to prevent pregnancy.

Bottom line – limiting your number of sexual partners and getting pap smears regularly are the most important things you can do to prevent cervical cancer. There is also a vaccine to prevent HPV, but remember that it only protects against 2 of the 12 subtypes of HPV that cause cervical cancer, so it’s not a panacea.

And remember, the pill cuts the risk of ovarian cancer, a protective effect that lasts up to 20 years after you stop the pill. It also reduces your risks of endometrial cancer. And keeps your menstrual cycles shorter, lighter and less painful. Not to mention it prevents pregnancy.

A Gynecologist’s Perspective

I’ve been a practicing gynecologist for 20 years now. In that time, I can remember only 1 case of cervical cancer in my private practice, in a woman age 60 who was completely cured with a hysterectomy. (The cancer was so small they could not find it in the hysterectomy specimen because I had removed it all with my office biopsy.)

I recall many more cases of cervical cancer from my residency, most during my oncology rotation, and all in women who had not had pap smears in years. I remember vividly the woman who presented to the ER bleeding from a large cancer on her cervix. She had not seen a doctor since giving birth to the last of her 7 children, who was now 25 years old. I don’t think she ever took birth control pills.

On the other hand, I’ve lost count of the number of unplanned pregnancies that have occurred among my patients, and the number of my patients who have had abortions for an unwanted pregnancy.

Given this experience, I see no reason for woman to stop taking the birth control pills because of concerns about cervical cancer.

I can think of only one situation where I might tell a woman to stop the pill for this reason. That is the rare patient with recurrent cervical dysplasia and persistent HPV infection that does not clear. I had one such patient, and I changed her to the progesterone-only pill. She is doing well.

Keeping Your Fertility Options Open

What do you do when you’re 35, have 3 kids and for various reasons have run out of acceptable contraceptive options? You have a surgical sterilization, that’s what.

But here’s the question – who gets snipped, the male or the female member of the couple? I almost always advise that the male should be the one.

It’s not personal, guys. It’s because vasectomy is a brief office procedure performed under local anesthesia, compared to a tubal ligation, which is an intra-abdominal procedure performed under general anesthesia. A no-scalpel vasectomy can be performed in as little as 7 minutes, with exceedingly low rates of complications.

“As a couple,” I usually say, ” “Your safest option is a vasectomy”.

But a patient recently objected to the idea of a vasectomy, because it was really her decision to stop having children. Hubby would have kept on going if she had been willing.

“If anything ever happened to me, I would want him to be able to have more children,” she said.

Now this was a woman who had already had several C-sections. Neither she nor her huband liked the idea of her having another surgical procedure. What to do?

“Have him freeze some sperm before the vasectomy”, I said. “That way he may still be able to father children in the future if anything ever happens to you.”

And that’s what they did.

Sperm Banking Before Vasectomy

Sperm banking before vasectomy is not a guarantee of future fertility, since frozen and thawed sperm may be less viable than fresh sperm. Overall, pregnancy rates using cryo-preserved sperm are about 50% lower than with fresh sperm. Assisted reproductive technologies such as intracytoplasmic sperm injection (ICSI) may improve these odds.

How long can frozen sperm be saved? Well, pregnancies have been reported using thawed sperm that have been frozen up to 21 years!

Sperm banking is not terribly expensive, with costs of about $500 per year. Sperm should be frozen and thawed as a test prior to vasectomy to see if they survive storage. And experts advise banking multiple samples in two separate sperm banks as insurance against lab accidents.

When weighed against the option of vasectomy reversal surgery, hedging your bets by sperm banking before getting snipped seems a reasonable option.

A word of caution, though. Urologists who perorm vasectomy generally advise that vasectomy be reserved for men who are really sure they want no more children.

In other words, if are considering banking some sperm because you’re not sure if you will want children in the future, then consider the possibility that you may not be ready for permanent sterilization.

Trojan’s Ad Needs to Evolve

Trojan has mounted (oops – Freudian slip?) a new ad campaign urging young men to be sexually responsible by using a condom every time they have sex. The mantra : It’s time we evolve. From their website:

Sex itself isn’t an unhealthy thing that needs to be policed or demonized; it’s a natural expression of our humanity. Using protection consistently and correctly is a critical component to managing one’s sexual health.

Trojan claims they are trying to break down the predjudice that condom use automatically mean promiscuity. From today’s NY Times:

“We have to change the perception that carrying a condom for women or men is a sign they’re on the prowl and just want to have sex,” said Linda Kaplan Thaler, chief executive of the Kaplan Thaler Group, the New York advertising agency that created the “Evolve” campaign.

Unfortunately, Trojan seems to be sending that exact message with their ad. Set entirely in a bar, with a cute little ditty of a tune beneath it, the ad shows men, portrayed (literally) as pigs, on the prowl trying to pick up a series of girls, all of whom seem to be alone at the bar. None of the pigs are successful. But then, one pig heads to a vending machine and buys a condom, at which point he is transformed into the cutie that he really is, and gets the girl.

Message? – Carrying condoms will get you laid.

Fox and CBS are refusing to air the ad. I’m not sure why – this ad is no worse than what they are showing 24-7 on their stations already. I say air it and let’s get this conversation going.

Trojan – Bad start, but at least it’s a start. Keep trying – I’ll be watching. And so will millions of young men. See if you can find a way to reach them in a way that doesn’t cheapen women or promote promiscuity. You’ve got some brilliant advertising folks working for you – I’m sure they can help you figure it out …

Outrage

Today’s Supreme Court decision constitutes an absolutely unprecedented intrusion into the practice of medicine and into the relationship between a woman and her doctor. Every physician in America should be outraged. And to not provide an exception in the law for the health of the mother shows complete and utter disregard for women.

One shining star in this dark sky is Ruth Bader-Binsberg, who was so outraged that she chose to read her dissenting opinion, apparently something rarely done. Here’s just a little of what she said:

In sum, the notion that the Partial-Birth Abortion Ban Act furthers any legitimate governmental interest is, quite simply, irrational. The Court’s defense of the statute provides no saving explanation. In candor, the Act, and the Court’s defense of it, cannot be understood as anything other than an effort to chip away at a right declared again and again by this Court—and with increasing comprehension of its centrality to women’s lives.

I encourage you to read Bader-Ginsberg’s opinion in its entirety. It is brillliant, beautifully written, and utterly dismantles the majority opinion. She shows without a doubt that those in the majority chose to completely ignore not only the legal precedent but every bit of legitimate medical evidence presented to them.

You may argue all you want as to whether or not you personally believe in abortion, but at this point in time, abortion is legal. The courts have no right to decide what technique a physician uses to perform that legal act. That decision is made by the physician and the woman, with her health and best interests in mind.

It is time that the Supreme Court take down the statue of Justice that stands at their doorstep. Let’s stop pretending that justice is what this court hands out. For justice is a woman. And this Supreme Court has no right to display her as their icon.

Union Pacific and Contraceptive Coverage – What’s Really Going On?

All right, I’m confused.

Union Pacific goes to a higher court to argue that they do not have to provide healthcare coverage for the cost of prescription contraceptives, and they win.

Than I read in the NY Times that the Union Pacific, which has been providing coverage for contraception since they lost the initial lower court case in 2005, does not intend to take the coverage away.

In July 2005, a federal district court in Nebraska ruled in favor of the plaintiffs and ordered Union Pacific to cover all prescription contraception approved by the Food and Drug Administration.

Under Thursday’s ruling, the company could end that coverage. But a spokesman for Union Pacific, the nation’s largest rail line with more than 50,000 workers, said yesterday that the coverage would continue.

“We’re not going to take it away,” the spokesman, Mark Davis, said. The ruling covers all of the railroad’s unionized female employees.

So what were they doing in court????

Addendum:

Okay, so I may have figured it out. Apparently after UP initially filed their appeal, collective bargaining between the railroads and the unions led to contraceptive coverage anyway, so they can’t back out on it now.

However the 8th Circuit ruling means that UP won’t have to pay the plaintiffs attornies’ fees or back contraceptive costs. Still, I can’t help but wonder who else was pushing them to continue their appeal on this one. It has such far reaching impact…

Union Pacific and Contraceptive Coverage – What’s Really Going On?

All right, I’m confused.

Union Pacific goes to a higher court to argue that they do not have to provide healthcare coverage for the cost of prescription contraceptives, and they win.

Than I read in the NY Times that the Union Pacific, which has been providing coverage for contraception since they lost the initial lower court case in 2005, does not intend to take the coverage away.

In July 2005, a federal district court in Nebraska ruled in favor of the plaintiffs and ordered Union Pacific to cover all prescription contraception approved by the Food and Drug Administration.

Under Thursday’s ruling, the company could end that coverage. But a spokesman for Union Pacific, the nation’s largest rail line with more than 50,000 workers, said yesterday that the coverage would continue.

“We’re not going to take it away,” the spokesman, Mark Davis, said. The ruling covers all of the railroad’s unionized female employees.

So what were they doing in court????

Addendum:

Okay, so I may have figured it out. Apparently after UP initially filed their appeal, collective bargaining between the railroads and the unions led to contraceptive coverage anyway, so they can’t back out on it now.

However the 8th Circuit ruling means that UP won’t have to pay the plaintiffs attornies’ fees or back contraceptive costs. Still, I can’t help but wonder who else was pushing them to continue their appeal on this one. It has such far reaching impact…

Judges Uphold Union Pacific’s Right to Refuse Payment for Birth Control

In yet another backward step for reproductive rights of women, the Eighth Circuit Court of Appeals, in a 2 to 1 decision, reversed a lower court decision in favor of the female employees of Union Pacific Railroad, who had successfully sued their employer in 2005 for refusing to cover prescription contraceptives in their employee health plan.

The court argued that, since the plan did not cover contraception for men or women, it did not discriminate against women.

Union Pacific’s health plans do not cover any contraception used by women such as birth control, sponges, diaphragms, intrauterine devices or tubal ligations or any contraception used by men such as condoms and vasectomies. Therefore, the coverage provided to women is not less favorable than that provided to men. Thus, there is no violation of Title VII.

The judges sidestepped the one of the major arguments in support of the plaintiffs – That since UP covered Viagra and drugs for male baldness, it should cover contraception. Here’s the opinion again:

We decline to address whether pregnancy is a “disease.” Instead, we simply hold that the district court erred in using the comparator “medicines or medical services [that] prevent employees from developing diseases or conditions that pose an equal or lesser threat to employees’ health than does pregnancy.”

Believe it or not, Union Pacific was named by Working Mother Magazine as one of it’s 100 best companies to work for in 2006. How that happened, I’ll never know….

Turning Lemons into Lemonade

Gynecology can be a bit of a schizophrenic field. I don’t know of any other area of medicine where the desired clinical outcome can be so completely opposite. I’m speaking of course, about pregnancy. We’re either trying to prevent it, or trying to make it happen, not infrequently in the same patient, just at different times in her life.

One upside to this schizophrenic medicine is that if a treatment worsens one of the outcomes, it may then be good for the other. Take, for example, the Cox-2 inhibitors (Vioxx, Celebrex, Bextra).

COX-2 and the Ovary

Cox-2 is shorthand for cyclo-oxygenase 2, an enzyme that catalyzes the production of prostaglandins from their precursor phospholipids. Prostaglandins are produced in cells all over the body, where they do things like cause smooth muscle to contract, or stimulate pain receptors. They are why you may have menstrual cramps, among other things.

Cox-2 in the prostglandin production pathway

But prostaglandins are not just bad guys – they are thought to have an important role in the physiologic process of ovulation. The ovary has it’s own stores of prostaglandin precursors and cox-2. As ovulation time nears, cox-2 activity in the follicle increases, converting the precursors to prostaglandins. The prostaglandins act to break down the follicle wall and contract the smooth muscle cells in the wall of the ovary, leading to extrusion of the egg. Pretty neat, huh?

Just how important is the Cox-2 enzyme to ovulation? Well, let’s just say that knock-out mice lacking the enzyme are completely infertile. I’d call that important, wouldn’t you?

Cox-2 Inhibitors (The Lemon Part)

Now, as I said before, drugs that interfere with Cox-2 are called Co-x 2 inhibitors. You know them as Bextra, Celebrex and the now defunct Vioxx. You may even have taken them for treatment of menstrual cramps. (For which they are an effective treatment.)

But now that you know what Cox-2 does, you won’t be surprised to find out that taking them can interfere with ovulation. (That’s the lemon part.) In fact, the adverse effect on ovulation is strong enough that it is recommended that women avoid using the Cox-2 inhibitors if they are trying to get pregnant.

A Different Angle (The Lemonade Part)

But, let’s think about it another way, as did the authors of a very interesting study published last month in Human Reproduction.

The investigators took women who were just about to ovulate, and randomized them to receive either the emergency contraceptive pill (ECP) or the ECP + a Cox-2 inhibitor. (Remember that the primary mechanism of action of the ECP is to inhibit ovulation.)

As the graph shows, the addition of the cox 2 inhibitor increased the number of cycles where ovulation was inhibited. This effect was strongest the farther away from ovulation the meds were given, so that the larger the follicle,and the closer to ovulation, the lower the odds were that the treatment would prevent the follicle from rupturing. That’s probably because cox-2 activity is kind of like a runaway train – if you get it early, you can put on the brakes, but if you wait too long, well, let’s just say you’d better step out of the way…

Conclusion? Cox-2 inhibitors are a bad thing if you are trying to get pregnant. But if pregnancy is something you’re trying to avoid right now, they may prove to be quite useful medications.

See? Lemonade.

Make your own Lemonade

The key to great lemonade is to dissolve the sugar by making a syrup. Add some fresh mint to your glass for a special taste.

1 cup of sugar
1 cup of water
Juice of 4-6 lemons (about 1cup)

Pour water into a small sauce pan. Add sugar, and heat, stirring frequently, until the sugar is dissolved completely. Cool a bit. Add the juice and the sugar water to a pitcher. Add around 4 cups of cold water, more or less to the desired strength. Refrigerate 30 to 40 minutes.

Serve with ice and sliced lemons. Serves 6.
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References: Massai MR et al. Human Reproduction 2006; 22: 434-439. / Sirois J et al. Human Reproduction Update 2004 10(5):373-385. (Photos used with permission from Photostock.com. Pathway used with permission from Wickipedia.

Snaps to Brown University

I got a call from the on-campus Pharmacy at Brown University today, requesting refills on my patient’s birth control pills. Turns out Brown University is one of only 2 campuses in their state who have an on-campus pharmacy, which is affiliated with the campus Health Service. I’m sure that a lot of their business is antibiotics and other medications needed by the students there. But I’ll bet they fill a lot of birth control prescriptions. And I think that’s just great.

Anything we can do that removes a barrier between young people and contraception gets snaps from me. Most college health services require you to leave campus and go to a local pharmacy to fill your presriptions. Here in the big city, that’s not too much of a problem. But put a college in the middle of nowhere, and for students without a car, that’s a significant disadvantage. Some schools get around it by giving out pills for free through subsidy programs, which is even better. But if you can’t do that, an on-campus pharmacy is the next best thing, as far as I’m concerned.

And though I focus on the contraceptive issue (after all, it’s what I do), it’s even more impressive that kids with conditions like asthma and diabetes can get their meds right on campus.

What are snaps? Well, if Legally Blonde 2 was showing at your house two times this weekend (once with your younger daughter and her sleepover friend, and the next day when your older daughter insisted on seeing it before it went back to the video store), you would know…

Another So-Called “Teen” Pregnancy

She’s 16 and 9 weeks pregnant, having come to the resident’s clinic this afternoon complaining of bleeding after intercourse 2 days ago. The baby is fine (very cute on sono, we all agree), but it’s clear by her exam that she has a rather severe infection of her cervix, most likely due to Chlamydia. On further questioning she admits to having been treated for Chlamydia not too long ago.

“Did your boyfriend get treated?”

No, he didn’t. He told her that his doctor told him he didn’t have Chlamydia, so he didn’t need to be treated. This of course, cannot be true, because we treat anyone potentially exposed. Which means that her boyfriend did not go to a doctor – he basically lied to her.

He’s 21, the FOB. That means “Father of the Baby” in OB chart-speak, although I could think of a similar acronym that might be more appropriate. He also sleeps with his other baby’s mother, who is 15. She has a 3 month old baby girl.

I ask my patient why she still sees this guy, if she knows he sleeps with another girl. “He’s my baby-father”, she says. “So when I get the urge, he’s the one I go to.”

So this means they all have chlamydia – her, her baby-father, and her baby-father’s other baby-mama. I tell her this, and ask to consider whether she really wants to continue sleeping with him.

And although our former surgeon general was forced to resign for suggesting that teens be taught about masturbation, I take my chances and tell her that there are other things she can do to satisfy her urges that don’t involve exposing herself and her baby to serious infection. I don’t know if I got through, but I hope so.

We treat her infection, talk to her about getting her partner treated, send some labs, talk to social work and make her a follow-up appointment. Her baby is due the end of September.

According to the Alan Guttmacher Institute, fathers of babies born to teens are often significantly older than their female partners. It is estimated that, among girls who have given birth to a child by age 15, 39 percent of the fathers are between the ages of 20 and 29.

Category: Second Opinions

Birth Control as Art

TBTAM the gynecologist was just a little overcome when she read this in a recent post by MegSpohn, who was describing the arts scene in Denver.

“Have you seen “Invesco Field at Mile High?” Looks like a diaphragm that has Jumbo-vision and seats thousands. We also have some weird public art outside the Convention Center that’s kind of a giant, rusty, coiled spring, which of course reminds me of an I.U.D. that someone left out in front of the Convention Center.”

Now that’s a girl who’s in touch with her inner-gynecologist.