Category Archives: Family Planning

04.12.12

Now For the Good News – Depo-Provera Prevents Ovarian Cancer

We’ve known for years that birth control pills protect against ovarian cancer, with an up to 80% reduction in risk with long term use.  Now it appears that use of Depo-Provera may convey a similar benefit.

In a large multicenter case control study in Thailand, published ahead of print in the upcoming issue of the British Journal of Ob-Gyn, use of Depo Provera led to a 39% reduction in ovarian cancer risk. Long term use for three years or more reduced the risk of ovarian cancer by a whopping 83%.  Oh, and by the way, in case you didn’t know it, Depo-Provera also protects against uterine cancer, doing it so well that it is actually used as treatment for uterine cancer.

That’s important information for women using Depo Provera to know, particularly in light of recent media attention to the potential for breast cancer in long term Depo Provera users under age 35.

To put it all into perspective, the risk for breast cancer in women under age 35 is about a 0.2% (1 in 500). The lifetime risk for ovarian cancer is about 1.5% (1 in 66). The lifetime risk of endometrial cancer is about 2.5% (1 in 40). Unlike the possible breast cancer risks, which disappear when Depo-Provera is stopped, the protections against ovarian and endometrial cancer appear to be lifelong.

All of these cancer risks are low in comparison to the risk of unplanned pregnancy, which comprise close to half of the pregnancies conceived each year in the United States. For most women, concerns about raising or lowering cancer risk is not the driving force behind choice of contraceptive.  But on balance, the cancer risk/benefit ratio of Depo-Provera appears to be quite favorable and on par with that of combined oral contraceptives.

For women who need effective birth control, that’s good news.

1 Comment
04.09.12

Depo-Provera Use Does Not Raise Overall Breast Cancer Risk in Young Women

That’s the headline the media should have used when publicizing the results of a recent study comparing Depo-Provera use among women ages 20-44 with or without breast cancer. Because that’s exactly what the study’s authors found.

There was no difference in exposure to Depo-Provera among women with breast cancer compared to controls - about 11% of women in each group had ever used Depo-Provera.

Small Sub-group analysis raised a question

However, the researchers also did what is called sub-group analysis – looking at smaller and smaller groups within the breast cancer study population to see if they could find any women who might have a higher risk from Depo-Provera use, even if the overall group did not.

Before I get to those results, I need to point out that cases and controls, and Depo-Provera users and non-users had significant differences in body mass index, ethnicity, family history, age and pregnancy history – all factors related to breast cancer risk.  In addition, controls had had less mammograms than their counterparts who had breast cancer. There is also a large issue of recall bias at play in studies such as this, since we know that subjects with the disease or condition being studied tend to remember drug exposures better than controls do.

Despite these marked differences between the groups, no statistically significant difference was found between Depo-Provera use in breast cancer patients compared to controls.

BUT, when subgroup analysis was done, there was one group that showed a difference – women who had used Depo-Provera for a year or more within the past 5 years. Here’s the finding that led to the headlines -

However, recent users of DMPA (Depo-Provera) for 12 months or longer had a 2.2-fold increased risk of breast cancer (95% CI: 1.2-4.2).

That was all the media needed to hear, and they were off and running, with headlines such as “Depo-Provera shots tied to breast cancer ” and “Depo-Provera shots double breast cancer risk.” Such headlines fail to convey the overall results of the study in a way that is meaningful to anyone but the lawyers.

The Sub-Group analysis that raised concerns was conducted in less than 100 women

What the media did not tell you was that in this “large study”, the actual number of women in the sub-group that showed this statistically significant and concerning result was extremely small – only 34 controls and 36 cases had used Depo-Provera in the past 5 years. Among these, only 15 and 32 respectively had used Depo-Provera for a year or more in that time!

So there you have it – headlines based on a subgroup analysis of less than 100 women who were poorly matched to start with.

These kinds of studies raise far more questions than they answer

Subgroup analysis is a research tool to look for potential topics for further investigation or to inform questionable findings in the overall analysis. For researchers, this type of analysis can be valuable in defining areas for future larger study. But publicizing the results of a small subgroup analysis as if it were the findings of the larger group mis-represents the strength and reliability of the findings. And in this case, that publicity does nothing more that to frighten women away from using hormonal birth control.

I for one am not changing my prescribing practices around Depo-Provera based on this study. Depo-Provera remains an important contraceptive option for many women, although potential side effects (irregular bleeding, weight gain) limit its acceptability as a first line method for the majority of them.  Overall, about 3% of women who use contraception in the United States currently use Depo-Provera.

The discussion around breast cancer and current hormonal contraception is not new

The magnitude of the risk cited, and it’s relationship to current use of Depo-Provera in younger women, is similar to that which has been reported in the past in studies of oral contraceptives and breast cancer risk.  Specifically with Depo-Provera, the risk that appears in current users in some studies actually disappears with longer term use, suggesting that the mechanism may be acceleration of growth of pre-existing tumors, rather than induction of new cancers over time.

Overall, neither oral contraceptives nor Depo-Provera appear to increase lifetime risk of breast cancer. Both reduce the risk of endometrial cancers, and the pill reduces ovarian cancer risk.

Future research may elucidate better what the effect of medroxyprogesterone acetate, the drug in Depo-Provera and the one studied as hormone replacement in the Women’s Health Initiative, may be on breast cancer risk. For now, that risk has best been defined in post-menopausal women, and not in users of hormonal contraception.

_________________________________________________

Further reading on Breast Cancer Risks and Depo-Provera

  • Depot medroxyprogesterone acetate and breast cancer. A review of current knowledge. Drug Safety Review, 1996
  • WHO Study showed similar results in subgroup analysis for current use in women under age 35.
  • WHO Memorandum on Depo-Provera and Cancer risks.
  • New Zealand study showing risk with longer term use in younger women, with same limitation of small numbers
  • Pooled Analysis of WHO and New Zealand Studies . JAMA 1995

Conflict statement – In the late 90′s, I published two studies of Depo-Provera acceptance and continuation, one of which was partially funded by small investigator-initiated grant from Upjohn that paid part of my research assistant’s salary, along with an NIH training grant.  I have no current conflicts to report.

6 Comments
02.01.12

Pfizer Recalls Lo-Ovral & Its Generic Birth Control Pill. What Should You Do?

You’ve heard by now that Pfizer has recalled about a million birth control pills due to concerns the the hormone dosing and pill order in the packs could be wrong. This could affect the pills efficacy, exposing women to unplanned pregnancy.  There are no concerns beyond this about safety.

The pill they’ve recalled is called Lo-Ovral or its generic Norgestrel 0.3 mg/Ethinyl Estradiol 0.03mg. I’ve posted a list of the affected lots below. The first thing you need to do is check your pill pack against the list to see if you are taking a recalled pill.

If you’re not taking a recalled pack, take a deep breath and relax. Then share this post on Facebook or wherever you share, so that your friends who may be taking a recalled pill learn about it as soon as possible.

What should you do if you are taking a recalled pack?

Talk to your doctor about what you should do if you are taking a recalled pack. Here’s what I’ll be telling my affected patients.  (Disclaimer – What follows is advice I will be giving my patients.  What your doctor may want you to do could differ. )

  • First of all, don’t panic.  If you’re not spotting or bleeding out of schedule,  you’re probably still protected against pregnancy. But make no assumptions – Presume you are unprotected and follow the steps below.
  • Head immediately to the pharmacy for a new pack of pills.
  • If you’ve been sexually active since your last period, do a pregnancy test. If it’s negative (and it most likely will be negative), start your new pack immediately and use condoms for the next two weeks. Your next period should come at the end of your new pack of pills. If it does not, do another pregnancy test. If you don’t want to wait till then to be sure you’re not pregnant, you can do a second pregnancy test two to three weeks after the first.
  • If you’ve had sex in the past 5 days, discuss with your doc if you should consider taking emergency contraception.
  • If you haven’t been sexually active, no harm has been done. Get a new pack and start it right away. Use condoms if you have sex in the next two weeks.
  • If you’re pregnant, contact your doctor. What you decide is up to you, but know that accidental exposure to normal doses of birth control pills in early pregnancy should not impact the pregnancy outcome.

4 Comments
12.29.11

Teen Mom Kailyn Gets Mirena – Contraceptive Choice or Product Placement?

In this week’s episode of Teen Mom 2, Kailyn heads to her gynecologist for birth control and leaves with a Mirena IUD in her uterus.

The entire encounter, obviously edited, ran more like a commercial for Mirena than a contraceptive counseling session. Other contraceptives were mentioned generically only  -”a patch”, “a ring”, “the pill” – but when it came to the IUD, all we hear is the word Mirena – six times, to be exact, during the entire 2 and a half minute encounter with the doc.

DOC: If you don’t like the birth control pill, you do have other options. You know that there’s a birth control patch.
KAILYN: (suspiciously) Yeah
DOC: There’s a once a month vaginal ring. The ring itself is not uncomfortable. (Hands her the ring) They’re one size fits all – Right Isaac? (Baby plays with Nuvaring) They’re cool, right?
KAILYN: I just feel like me putting something in myself is all that much more room for error.
DOC: There’s also the Mirena.
KAILYN: Whaaaat is Mirena?
DOC: The Mirena goes right inside your uterus. They’re THE most effective method of birth control available because it really doesn’t rely on you to do anything or remember to do anything. (Part of a pamphlet shot) That’s what it looks like. It lasts for 5 years. If before 5 years you decide you want to have another child, it’s very easy to remove a Mirena right in the office.
KAILYN: I think I want Mirena.
DOC: If you want to, we can put it in today – and it only takes about a minute to put it in.
KAILYN: Does it hurt?
DOC: It’ll hurt a little tiny bit for a few seconds when it goes in
KAILYN: OK.All right – let’s do it.
DOC: You’re sure?
KAILYN: I’m sure
DOC: I’ll get you set up for it then.
(Staff member, who appears to have been waiting outside the door on cue walks in and offers to take the baby. Kailyn next gets onto table and we cut to Doc doing insertion.)
DOC: All right, if at any point it’s too much, we’ll stop…All right, this is the part that causes the little cramp (Kailyn winces slightly) You’re Mirena is in! You have birth control for FIVE YEARS. You can push yourself up off the edge.
KAILYN: So I’m being protected right now?
DOC: Immediately
KAILYN: I feel better already
DOC: (Smiles) Good. And I will recheck it for you in 6 weeks. Call me in the meantime if you need something before then.
KAILYN: All right, thank you.
(“Protected” stamped across screen. Fade out)

What Kailyn (and MTV’s millions of teen viewers) didn’t hear about Mirena

No one appears to have told Kailyn about anything other than Mirena’s convenience and efficacy and that it pinched a bit going in.

There is no mention that if Kailyn chooses Mirena, she should be prepared for changes in her menstrual cycle, most likely irregular spotting and over time, absence of menses.

Or that Mirena may worsen what appears to be her already pretty bad case of acne, so let’s have a plan for handling that up front.  (Or maybe reconsider Nuvaring – it’s actually pretty darned easy to use and could actually help her skin.)

No one mentioned  that there is another IUD called Paragard that acts a little differently. Or that IUD’s in general carry a small risk of pelvic infection at the time of insertion, should not be used by women who have already had PID, and don’t protect against STD’s, so is her boyfriend still going to use a condom?

All MTV viewers saw was a young woman dismissing every other form of birth control and happily leaving her doctor’s office with Mirena. Best 180 seconds of product marketing Bayer ever got.

Kailyn chose Mirena, but will she continue it?

If Kailyn’s counseling session really went down the way it was edited, I’d have concerns that she was not adequately prepared for the actual experience of having a Mirena, and might end up discontinuing her IUD much sooner than either she or her doctor expect.  She wouldn’t be alone in that regard – Early data suggest that close to 50% of teens will discontinue their IUD in the first 1-2 years of use.

Let’s not set teens up for failure by hyping Mirena on reality TV. Tell them what they need to know in order to make responsible, informed decisions.

It’s called contraceptive choice. Not Contraceptive marketing.

4 Comments
12.19.11

Pharmacies Commonly Deny Older Teens Access to Emergency Contraception

It’s bad enough that the federal government is preventing younger teens from getting easier access to the morning after pill.

Now we find out that older teens, who by current law should be able to buy ECP’s without a prescription, are being told by pharmacies that they can’t. 

In a phone survey conducted by researchers in five cities nationwide, pharmacies gave a disturbingly high rate of incorrect information out to callers posing as 17 year olds seeking access to the morning after pill, telling them that they could not obtain it based on their age.

The availability of emergency contraception did not differ based on neighborhood income… However, in 19% (n = 138) of calls, the adolescent was told she could not obtain emergency contraception under any circumstance. This misinformation occurred more often (23.7% vs 14.6%) among pharmacies in low-income neighborhoods (adjusted odds ratio [AOR], 1.93; 95% CI, 1.53-2.43). When callers queried the age threshold for over-the-counter access, they were given the correct age less often by pharmacies in low-income neighborhoods (50.0% vs 62.8%; AOR, 0.59 [95% CI, 0.45-0.79]). In all but 11 calls, the incorrect age was stated as erroneously too high, potentially restricting access. Adjusting analyses for pharmacy chain as a fixed effect yielded virtually identical results.

The back and forth on teen access to ECP has been confusing, to say the least.  But since 2009, teens age 17 and older have had over the counter access to Plan B.

Pharmacists need to get the rules straight.

 

1 Comment
12.11.11

Birth Control & Blood Clots – Visualizing The Risks

If you’ve been using the Patch, Yaz or Yasmin, you’ve got to be wondering in the wake of this week’s news whether or not you should reconsider your choice of contraceptive. After all, the FDA has pretty much confirmed that these methods have a higher risk of blood clots than older birth control pills. By now, your mom has probably called you and told you to get off that nasty pill, your roommate may already have hidden next week’s patch from you, and you’re holding your breath waiting for a call back from your doctor, who’s probably fielding about a hundred calls today alone from worried pill and patch users

All you really want to know, though, is this -

What’s My Risk? 

It’s an important question that deserves an answer and a conversation with  your doctor. Let’s see if I can help inform that discussion. But first, you need to know a a bit about the subject at hand – blood clots.

What are Blood Clots?

Blood clots are blockages in the vein or artery that occurs when the blood coagulates in the blood vessels.

  • A DVT (deep veinous thrombosis) occurs when blood coagulates in the veins of the leg or arm, where it causes pain, swelling and inflammation.
  • A PE (pulmonary embolus) occurs when a clot forms in the lungs or breaks off from a DVT in the leg and gets lodged in the lung. PE’s causes shortness of breath and chest pain, and if large enough, lack of oxygen and even death.

DVTs and PEs are treated with blood thinners, which almost always work to dissolve the clot, although long term sequelae of the clot can occur.

  • Clots to the heart and brain are exceedingly rare in young women. In birth control pill users, that risk is confined to women over 35 who smoke (and should not use estrogen containing hormonal birth control) and women who suffer from ischemic migraine with aura or underlying medical problems such as heart arrythmias that predispose them to stoke. (Women over 35 with regular migraine may also be at increased risk).

For the otherwise normal, healthy young woman on pills or the Patch, the risk for heart attack and stroke is just too rare to even begin to compare between users and non-users of these methods. And in fact, these risks have not been reliably shown to differ between currently marketed methods. So in this discussion we’re going to confine ourselves to talking about the risk from DVT, where the data appear to be a bit clearer.

How does Birth Control cause blood clots?  

Birth control methods that contain estrogen increase the risks of blood clots by altering the delicate balance of clotting factors produced in the liver. In spite of this, however, most women taking estrogen don’t get clots. So, other factors must also be at play for a clot to form.  Here are those other factors that we know and understand -

  • Long plane flights and car rides. Prolonged immobilization can cause the blood to pool in the legs and clot. In my two decades of practice, almost every clot I’ve seen in my patients using estrogen containing birth control occurred after a long plane flight or car ride. That’s why it’s so important to get out of your seat and walk around on a long plane flight and make frequent stops on long car rides.  And, unless they’re rising in business or first class with a seat that allows them to elevate their legs, I also advise all my patients taking estrogen to wear knee high travel compression socks, since studies have shown that these can lower clot risks due to plane travel.
  • Genetic mutations / Family History. Some people are predisposed to clotting because they carry a mutation in their clotting factors, the most common of which is Factor V Leyden mutation, found in about 5% of the population. Women with such mutations should avoid estrogen. Some day we’ll have an inexpensive blood test to identify these women, but right now the best clue to a genetic mutation is a family history of blood clots. In families with such histories, genetic screening can be done in the affected individuals to identify the mutation and then screening of other family members to find out who is at risk.
  • Obesity and smoking also increase the risks of clotting, in the arteries as well as the veins. Women over 35 who smoke should not use estrogen containing birth control.
  • Surgery and hospitalization. Prolonged immobilization is the reason. Hospitals use compression stocking, pneumatic air pumping leg wraps and even low doses of blood thinners to prevent clots due to hospitalization. (God forbid they get the patients up and walking, but that takes nursing staff, and we’d rather spend the dollars on devices and drugs, don’t get me started…)
  • Varicose veins. Birth control pills don’t cause varicose veins, but women who have varicosities (not superficial tiny spider veins, but large deep veins in the leg) have a higher risk of clotting due to pooling of the blood in the veins of the extremities.
  • Advancing Age. The biggest factor associated with blood clot risks is age, with the elderly being at particularly high risk compared to younger individuals. However, pills are generally still safe to use in healthy women up to the age of menopause.
  • Pregnancy. Perhaps the highest risk women take for blood clots is during pregnany, a time when your risk for clotting increases up to 5 times the rate in non-pregnant women.  Here, the hormone of pregnancy, fluid shifts and edema in the legs are culprits. Researchers often compare the risks of hormonal birth control to the risk of pregnancy, although a better comparison is to compare it to the risk from using another method, combined with the risk of getting pregnant from that method if it is less effective.

The progestin component of pills

Scientists believe one of the factors affecting clot risk in one method vs another may be the progestin component.

  • Northindrone (1st generation progestin)
  • Levonogestrel (2nd generation progestin)
  • Norgestimate, desogestrel, gestodene (3rd generation progestins)
  • Dropeserinone (the progestin in Yaz)

Why? It’s not so clear, and some experts maintain that it makes no biologic sense that, estrogen dose being equal, progestins should impact clot risk at all. Despite this, research is mounting that lower clot risks seem to exist for first and second generation pills. Norgestimate pills may have a similarly low risk, perhaps because they are metabolized in the body to levonorgestrel. The progestin in the Patch is metabolized to norgestimate, but the higher estrgoen dose in the patch probably contributes to that method’s higher clot risk compared to norgestimate pills.

Now that you’re an expert on blood clots, let’s visualize the risks of your birth control

Because the risk of PE is so low, most studies either combined DVT and PE risk, or report on DVT risks alone, which is what I’m going to do.  In general using the patch or  yaz will increase your odds of a DVT by about 50% – that’s called relative risk of 1.5. Translating that to absolute risks is difficult, because the actual numbers of clots occurring in a given study depends on so many things, not the least of which is how they define that a clot has occurred. Each study the FDA examined used a slightly different methodology – some used pharmacy database prescriptions for blood thinners, some used claims-based diagnoses and others added confirmatory chart reviews. Each method has it’s biases, and none is perfect.

Absoute Risk DVT- Background

The background rate of clots among healthy women of reproductive age that I have seen most often quoted in the literature is about 4 per 10,000.  This is your risk if you do not take hormonal birth control.The dots represent 10,000 women over a year’s time, with brown dots unaffected women and red dots those who have a DVT.

DVT Risk – Levonorgestrel and norgestimate pills

The risk in users of second generation pills containing levonorgestrel, or 3rd generation norgestimate pills is about 6 per 10,000. This is the risk that Ortho Evra and Yaz were compared to by the FDA. Here’s what that looks like -

DVT Risk – Ortho Evra Patch

Use of the patch increases that risk to 9 per 10,000.  Here’s what that looks like -

In case you’re having trouble visualizing it, I’ll put it side-by-side.

So you can see, as reported to the FDA,there is an excess of about 3 cases of clots per 10,000 women using the patch compared with those using an older pill. If you’re on the patch, clot risk does not appear to diminish over time. So your excess risk remains about 3 per 10,000 as long as you use the patch.

DVT Risk – Yaz

The risk from using Yaz and Yasmin comes in pretty close to that of the patch, at around 10 per 10,0000. The risk for clots with Yaz decreases the longer you use it. So if you’ve been on it for over a year with no clot, your risk drops significantly for getting a clot in the future, to about 5 per 10,000.

DVT Risk -Pregnancy

Finally, what about the clot risk from pregnancy? Actually, that’s the highest risk of all – about 20 per 10,000 or 2 per 1,000.

What about the Ring? And pills containing desogestrel?

Excellent question. The FDA hasn’t addressed the clot risk with the Ring specifically outside of the FDA approval process. We do know that the ring imparts a significantly lower estrogen exposure than the patch and a 35 ug pill, but it’s unclear if that translates to a lower clot risk. The ring, after all, contains etononorgestrel,  the active metabolite of desogestrel.

Pills containing desogestrel have come in at a risk of about double that of levonorgestrel pills, so I’m going to assume in the absence of data to prove otherwise that the  risk of the ring would be about 8 per 10,000.

Why does it take so long for us to learn about these risks for methods that are already on the market?

Almost all newer contraceptives will have an undefined clot risk, since clinical trials are just too small to detect a statistically significant increase in clots, which as you know now are relatively uncommon events. It’s only when a method makes it out into the general population of millions of women that an increased clot risk becomes evident. (Of course, if the manufacturer does not report all the clots that occur in a trial, that’s a different story, and the subject of recent lawsuits related to Yaz.)

Bottom Line

Your chance of dying from a blood clot related to your contraceptive is about one in a million. The chance you’ll get a blood clot is well below one percent no matter what method of birth control you use.  In that very low risk range, your chance of a blood clot, in order of increasing risk, is -

       Method

Risk per 10,000*

Percent risk*
Non-hormonal. Not pregnant.

4 per 10,000

0.04 %
Levonorgestrel pills Noregstimate pills

6 per 10,000

0.06 %
Desogestrel Pills

8 per 10,000

0.08%
Nuvaring

? 8 per 10,000

0.08%
OrthoEvra Patch

9 per 10,000

0.09 %
Drosperinone pills

10 per 10,000

0.1%
Pregnancy

20 per 10,000

0.2%
* These numbers are estimates based on my best good faith interpretation of the literature and data presented to the FDA on 12/8-9/11. Better numbers may be forthcoming from the FDA or other sources in the future, but for now I need something for my patients and myself to work with. Margaret Polaneczky, MD

Bottom Line

Even if you take the pill or the patch, the odds are overwhelming that you’ll make it through your reproductive years without ever having a blood clot. 

The risk of actually dying from a blood clot due to your hormonal birth control is about one in a million.

If you want to avoid the clot risk associated with estrogen containing contraceptives, you can use something else for birth control. Depo provera, the progestin only pill, Implanon, the IUD and barriers such as condoms and diaphragm are all reasonable choices.Each of these methods come with their own risks and benefit, and none is perfect.

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Additional Reading from TBTAM

9 Comments
12.09.11

FDA Allows the Patch to Stay, But with Better Labeling Supporting an Informed Contraceptive Choice

After cautiously clearing Yaz for continued use yesterday, an FDA Advisory Panel today addressed post-marketing data showing similarly increased blood clot risks among users of the contraceptive patch.  The committee, after having been clearly quite  extensively briefed,  heard testimony from Ortho Evra’s  manufacturer and experts in epidemiology, gynecology and hematology. They also heard moving testimony about  a young woman who died from a massive pulmonary embolism while using the Nuvaring,whose parents argued that not only the Patch, but most of the newer methods carry an increased clot risk that no woman should be allowed to take without being adequately informed.

The committee ruled that despite limitations of the data, the patch most likely carried a 1.5 times relative risk of blood clots compared to 2nd generation levonogestrel pills, but not necessarily higher than that of newer pills containing 3rd and 4th generation progestins and drosperinone.  With a few dissenters, the committee voted to allow the Patch to stay on the market, but asked for new product labeling outlining the increased clot risks.

The Power of a Good Graphic

The Committee seemed to be particularly moved in their deliberations by a visual presentation from  the manufacturer showing that the relative risks of Ortho Evra, while elevated compared to older second generation oral contraceptives, were comparable to that of other newer contraceptives – all of which have remained on the market. A summary slide presented by Anita Nelson, MD, showing absolute risks clustering in a similar range between the patch and other new progestin-containing pills, appeared to be equally compelling in this regard.

In perhaps a reaction to the power of a good graphic, the committee also very astutely recognized that current package labeling is ineffective in conveying comparative risks between methods for both clinicians and their patients, and asked for visual representation of risk in package labeling. They also spent sometime brainstorming how to best communicate risks to patients in general, recognizing that leaving it to the manufacturers may not be the best way to accomplish this important goal.

The Patch – A Unique Method for a Niche Market

The group’s decision on the patch appears to have been impacted in large part by the opinion that the method has a unique place among contraceptive methods due to its transdermal delivery system., even if it is that very system which may be imparting the increased risk.  Although dissenters pointed out that research has not shown the patch to have improved efficacy or compliance over pills,  anecdotal reports from members of the committee and gynecologist Dr Anita Nelson stressed that for some of their patients, the patch was simply the only method they were willing and able to use.  This testimony from practicing physicians appeared to have influenced most of the  panel members, even those who argued initially that the method’s risks did not outweigh the benefit, that there was a niche group of women for women the method might still be appropriate.

As one member of the panel pointed out today, that niche has already been carved by adverse media reporting and the pull back of the manufacturer from DTC advertising and detailing of the method. As a result, the patch was now used by only about 2% of hormonal contraceptive users in 2010. It is this 2% that the Committee appeared to be considering in their decision top allow the patch to remain on the market. It’s a decision with which I have to agree.

Who are the patch users?

They’re sometimes women who have breakthrough bleeding on every pill they try. Women using anti-seizure drugs that cause hormone levels in lower dose pills to drop below the range of efficacy. Women with estrogen withdrawal headaches on pills, who want the efficacy of a hormone but need the steady levels a patch provides (and aren’t willing to use the ring).  And women who have gotten pregnant on pills, don’t want an IUD or Depo, and whose partners won’t wear condoms.

Now the FDA is making sure that they’re woman who’ve been informed that the price they pay for the benefits the patch provides is a slightly higher risk of blood clots. Hopefully, as a result of the FDA Panel’s deliberations today, the Patch’s (and other hormonal contraceptive method) package labeling will evolve from a medical legal document into a tool to truly inform and support an educated contraceptive choice.

__________________________________________________________

More on Today’s Ruling

4 Comments
12.08.11

Politics & The Morning After Pill


Kathleen Sibelius, head of HSS, has overruled the FDA and blocked its recommended approval of the emergency contraceptive Plan B for over the counter access. The move runs counter to Sibelius’  pro-choice record, and to President Obama’s stated commitment to uphold science over politics.

Her argument? She is protecting 11 year old girls, who she states do not have the cognitive maturity to use the medication correctly.

Apparently, though, 11 year olds have the maturity to use Tylenol, a drug that have been shown to cause serious side effects, and even death, if taken at too high a dose.  (Some studies suggest that even taking it at recommended doses for as little as 4 days can cause liver abnormalities.) In fact, if they want to, any 11 year old can purchase up to 100 Tylenol pills for less than a week’s allowance.

The morning after pill, on the other hand, has no serious side effects, even if taken improperly. At a cost of almost $50 for one pill, it is likely never to be purchased by anyone, adult or teen, in a dose large enough to do anything other than what it’s intended to do, which is to prevent an unplanned pregnancy.

This is a travesty.

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More on the Morning after Pill

8 Comments
10.31.11

The Mississippi Personhood Amendment – An Open Letter to Dr Freda Bush

On November 8, Mississippians will be voting on ballot amendment 26 , the so called “Personhood Amendment” that if passed, would declare a fertilized egg a person.

The question at hand is, would the Personhood Amendment be used to outlaw contraception?

Dr Freda Bush, an Ob-Gyn and spokesperson for the Personhood amendment in Mississippi, is misleading voters that it will not. In a press conference in support of the amendment in September, she stated this -

The personhood amendment will not ban the use of hormonal contraceptives.

The video of this press conference is being used to reassure voters about the intent of amendment 26. And yet the information Dr Bush presents about contraception and the amendment stands in complete contrast to that which the personhood movement itself has presented. Here is the standard “talking point” on contraception from personhood sites at states across the country seeking to pass similar amendments -

Won’t a Personhood Law Outlaw Contraceptives?

No, recognizing personhood has no effect on contraceptives because true “contra-ception” only prevents conception (fertilization). However, personhood would prohibit any chemical abortion that kills the youngest boys and girls before or after they implant in their mother’s womb. When the abortion industry says that personhood would outlaw contraceptives, it’s lying. These people have spent decades telling women that such chemicals did not kill a living embryo. Women should know whether or not a chemical would kill their children. A personhood law will end the lies.

It has been a long standing tenet of the anti-abortion movement that birth control pills are considered to be “chemical abortifacents”. They will most surely attempt to use this amendment, if passed, to outlaw hormonal contraception.

Still not convinced? Check out the Colorado Personhood website, where they adress what they call the “scare tactics” of those who oppose the amendment. Here, they try to convince voters that the amendment would not ban contraceptives, and yet in the end only barrier methods come out unscathed.

Contraception comes from the words “contra” and “conception”. Properly understood it means something that prevents conception. In 1965 the American College of Obstetricians and Gynecologists issued a medical bulletin which “officially” changed the definition of conception from the union of a sperm and an egg to implantation of the young human being in the wall of the uterus. The reason they did this was to make chemical abortifacients seem more palatable to the American people who would now be tricked into believing that the human being did not begin until implantation. While the AMA and pro-abortion bioethicists have tried to obfuscate the meaning of conception, embryology is very clear about the beginning of life: the beginning of life (under normal sexual reproduction) takes place when the sperm touches the ovum. Barrier methods of contraception that prevent the union of the sperm and the egg will not be outlawed, since neither a sperm nor an egg by itself is a human being.

Dr Bush, you and I both know that to our patients, the word “Contraception” means more than just condoms. You yourself have stated that you prescribe birth control pills in your practice. Can you honestly tell me that the “talking points” of this campaign do not encompass the intention of making such prescribing activities illegal?

You have admitted publicly since your press conference that

“I’m not the authority on what would and would not be banned”.

I think that is correct. And yet you have portrayed yourself as that authority. As a result, your press conference is being used to spread misinformation that directly contradicts what appears clearly to be the true intent of the law, which is to outlaw both abortion and any birth control method other than diaphragms and condoms.

Dr Bush, you must by now realize the full intentions of those who are using you. They are taking full advantage not only of your pro-life politics, but of your gender and your race to sway voters to vote against their own self-interest, for a bill that would limit their access to the contraceptives they have relied upon, and that you have prescribed, for years.

Fortunately, it’s not too late. You still have time to hold another press conference. To tell the public, and your patients, the truth about Amendment 26. Don’t tell them that their birth control is safe if you are not sure it is. Tell them the truth.

Your patients have trusted you for years. They deserve no less.

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Required reading - The Next Front in the Abortion Wars – Birth Control.

Photo credit – Phil Bryant, AP Photo. Licensed for editorial use.

11 Comments
10.23.11

Emergency Contraception is NOT an Abortifacent

When patients ask me how emergency contraception prevents pregnancy, I tell them that it’s primary mechanism is to delay ovulation (release of an unfertilized egg from the ovary).  There is no evidence that the EC aborts or prevents implantation of an already fertilized egg.

The efficacy of EC depends on where you are in your menstrual cycle when you have unprotected sex -

  • If you are destined to ovulate in the next 1-5 days, EC will delay the release of the egg from the ovary until the sperm have lost their viability in the reproductive tract. This is how it works.
  • If you’ve already ovulated and the egg is still in your reproductive tract, you’re possibly already pregnant by the time you take EC. If so, it’s not going to work.
  • If you’re not due to ovulate for >5 days or are 5 days or more past ovulation, then you’re unlikely to have gotten pregnant anyway, and the EC hasn’t done much. (But take it anyway, please, since not every ovulation is predictable)

Now a nicely done study reinforces yet again that delay of ovulation is indeed the mechanism by which this important contraceptive works to prevent pregnancy.

Researchers enrolled 450 women presenting for emergency contraception at a clinic in Chile,where they assessed where in their cycle these women were at the time of unprotected intercourse by using hormone assays and ultrasounds throughout the rest of that menstrual cycle to see if they ovulated, menstruated or became pregnant.  (Previous studies relied on menstrual history alone to pinpoint ovulation, a much less reliable methodology.) The EC used in this study was levonorgestrel.

Altogether, 103 women who took EC did so just prior to ovulating – Although 16 pregnancies would be expected in this group based on normative data, none of theses women became pregnant. In contrast, 45 women took EC on the day of ovulation – 8.7 pregnancies would be expected to occur in this group , and in fact, 8 pregnancies did occur.

The efficacy when used before ovulation was 100%. On the contrary, when used after ovulation has occurred, the number of observed and expected pregnancies is not statistically different, indicating that no reproductive process subsequent to ovulation is interfered with by LNG-EC. This finding is incompatible with the inhibition of implantation by LNG-EC and is consistent with the mechanism of action of EC reported in a recent review.

Other research has shown that EC does not alter the proteins in the endometrium necessary for the implantation of  the fertilized egg.

Although overall, EC has not had a major impact on unplanned pregnancy rates in the United States, it remains an important method of contraception for women. It’s important to counteract misinformation about its mechanism of action for women considering it’s use.

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More info on EC from The Emergency Contraception Website

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