New Contraception Options

November 15, 2011

think it’s important to start with why we need new. When it’s I think clear for many of our subscribers and many clinicians that the methods that we already have are very effective, that despite having very effective methods, throughout Europe, United States and around the world we are still met with very high rates of unintended pregnancy.

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Hans van der Slikke, MD:  “It’s October 2002 and we are at the ASRM in Seattle and next to me is Professor Lee Shulman from Illinois, Chicago, ‘Welcome’.” 

Lee P. Shulman, MD:  “Nice to be here, thank you Hans.” 

Hans van der Slikke, MD:  “I can welcome you today as a member of the Board of Contraception for OBGYN.net.” 

Lee P. Shulman, MD:  “Nice to be a part of it.” 

Hans van der Slikke, MD:  “Very…thank you very much for being part of it now.  And, now we’re here we can review some of the new types of contraception which are demonstrated these days during this conference and I want to ask you what’s really new, what are the new concepts today, what are the advantages, what are the drawbacks?” 

Lee P. Shulman, MD:  “I think it’s important to start with why we need new.  When it’s I think clear for many of our subscribers and many clinicians that the methods that we already have are very effective, that despite having very effective methods, throughout Europe, United States and around the world we are still met with very high rates of unintended pregnancy.  Speaking specifically for the United States and somewhat for other parts of the world, one issue is that it’s very clear that although oral contraceptive pills are very effective when used properly, there’s apparently a large number of women who don’t use their pills properly, either because they’ve not been well trained in how to use them or they’re perhaps not the right patient for that particular method.  And that’s why looking at methods that are not…do not require daily use can be an important, and should be an important, part of the counseling process.” 

Hans van der Slikke, MD:  “Or maybe more and more as well because they don’t like taking these pills every day and they are tired of taking it, they are scared for the side effects, like thrombosis.” 

Lee P. Shulman, MD:  “Absolutely.  You now, it’s funny, there’s a phrase called ‘the monkey on your back’, you want to get the monkey off your back, and a lot of my patients talk about the pill monkey, that they have to take a pill, day in and day out and their partners don’t have to do really anything.  It’s clear that having more acceptable, if you will, non-daily use methods is likely going to improve compliance, is likely going to improve, in a sense, the choices, not necessarily better choices but choices that are more likely to be used correctly and consistently because essentially all we want is for our patients to choose a method that they are going to likely to use properly.  So to that end, we’ve seen the last 18 months or so a really a wide array of new contraceptive options, non-daily use methods.  The first two that were essentially out of the box, if you will, in 2000, the year 2000, were the combination injectable, which is marketed in the United States as Lunelle, around the world as Lunella, which is a combination of a much lower dose of medroxyprogesterone acetate, 25 milligrams and a weak estrogen called Estradiol Cypionate.  It is not the next generation of Depo-Provera, it’s rather more like an injectable pill, rapidly reversible if patients so choose.  Regular cycles, obviously the major drawback it requires a monthly intra-muscular injection, so what its benefit is, is really its drawback.  But it has in a sense, drawn upon a relatively loyal, if you will, following in the United States.  Women who use it, who have been able to incorporate it, are very happy with the method.  Around the same time was the introduction of a new intra-uterine device, a level Norgestrel IUS, now I say introduction, I’m glad I’m speaking to you because this is not a new device in Europe…” 

Hans van der Slikke, MD:  “…been around for 20 years.” 

Lee P. Shulman, MD:  “Right.  It’s been used for about 15 or so years, the studies that were done in Finland...in the United States it’s a new device and I’m just going to say briefly, obviously I think many people know it’s reliable, safe and effective.  For me the potential impact of this method is not just as a contraceptive but as a treatment for gynecologic disorders and perhaps for hormone replacement, progestational hormone replacement therapy.” 

Hans van der Slikke, MD:  “Yes.” 

Lee P. Shulman, MD:  “But now we get to real new devices, new methods and the two that have been recently introduced in the United States have been the vaginal ring, marketed in the United States and I believe around the world, as the NuvaRing.” 

Hans van der Slikke, MD:  “This is similar in the world.” 

Lee P. Shulman, MD:  “Right.” 

Hans van der Slikke, MD:  “But in Europe it is the same name.” 

Lee P. Shulman, MD:  “Right.  And in the United States, soon to be in Europe, well in the United States the transdermal patch is called Ortho Evra.  I believe in Canada and in Europe it will just be called Evra, it will not be called Ortho Evra.  The vaginal ring and the transdermal patch are essentially systemic delivery systems.  One with a small ring that’s inserted in the vagina and in a conventional fashion it’s kept there for 21 days.  In the transdermal patch, it is a weekly patch that is replaced and removed, again for 21 days.  Both methods, very, very, very high rates of regular cyclicity, regular bleeding, excellent bleeding profiles, well accepted side-effect profiles.  What are the issues?  One is a patch that needs to be removed and replaced, the other is a foreign body within the vagina.  Again, speaking primarily that I have done to an American audience and not being able to take the American experience and sort of connect it to Asia or Europe or South America, the major issue for American clinicians is very simple.  Most American clinicians have looked at methods like the patch, like the ring and their older components, Depo-Provera, which I know is not used in Europe, but non-daily use methods as what I call ‘go-to’ methods.  Everyone starts with the Pill, when people mess up with the Pill then we go to another method.  And that’s the thinking that needs to change.  We have wonderful new options, again how they differ from the older methods, not in safety, not in efficacy but in side-effect profile.   And hopefully make them more amenable to wider use, not after there’s been a problem but to prevent the problem.  It really is, as an American, as a physician, I’m embarrassed by 50% of the pregnancies in the United States being unintended or unplanned.  We use no different methods than in Europe.  I would daresay that our training is very little different and yet we are beset with this profound social and economic problem that I think can be readily addressed by educating clinicians about these new methods.  Not getting them to take patients off methods that they’re happy with.  If they’re happy with them don’t mess with it.  But to find those women who are likely to do better on a non-daily use method.  Talk to them about what’s available and get them to start those.” 

Hans van der Slikke, MD:  “I agree with you.  It’s very important but don’t you think even a more important thing is how can you reach these women?  Most young women, most unemployed, uninsured…” 

Lee P. Shulman, MD:  “You’re right.” 

Hans van der Slikke, MD: “…how can you reach people and second, how can you convince them to use these tools, these…” 

Lee P. Shulman, MD:  “The second answer is easier than the first because as we’ve seen in the United States things like direct-to-consumer advertising really do set the stage for attitudes from women.  And it’s clear, whether or not we physicians like or don’t like direct-to-consumer advertising, it is in fact a reality in the United States.  And therefore, we can in fact change perceptions, whether we’re…that’s putting too much responsibility in the hands of people who we may not want that responsibility, it is still a fact of life.  So we can, and I think it’s important for methods like the patch, to get women to start thinking about that as a first line option, all right.  To come into their doctor’s office and say ‘Talk to me about the patch.  Talk to me about the Pill.’  The first issue is far more difficult because again I think as you are well aware both in Europe and in the United States, unfortunately a lot of women do not come for that first contraceptive counseling until they’ve already had a pregnancy, an unintended, unplanned, unprotected sexual event.  We know that, for example with adolescents, they usually do not come for contraceptive counseling and care until 12 months after their first sexual event, experience and that’s obviously leaving wide open the chances for life-altering issues.  What we have to do is make these methods available.  How that’s done is going to depend, at least in the Unites States, based on States, based on governments.  I will say that there have been certain companies that have been far more aggressive, for lack of a better term, in getting these methods available for Department of Public Health patients in the United States.  And unfortunately there are other companies that have not, in a sense, gone down that road until well afterwards.  And I think truly, that those companies that are going to be aggressive, not just in getting them on appropriate plans, but making it more readily available for women who cannot afford out-of-pocket expense, it is going to be in the short term far better for patients than in the long term.  Help make those products, in a sense, an accepted first line option instead of a go-to…you know, a method that clinicians and patients only think about after there’s been a problem.” 

Hans van der Slikke, MD:  “Are these patches and this ring over-the-counter?” 

Lee P. Shulman, MD:  “No, and that’s a continuing discussion in the United States.  We have really no…aside from barrier methods, condoms, we essentially do not have any appreciable over-the-counter contraceptive products.  Barrier methods, spermicidals, those types are over-the-counter.  There’s been a growing use of over-the-counter emergency contraception, although it’s not yet readily available, in some states they’ve made it more easy.  But that’s still a discussion that continues in the federal government as well as state governments.” 

Hans van der Slikke, MD:  “Yes, I see, it’s the same in The Netherlands but we all know, since last year the experience in France, that contraceptive pills over-the-counter and the number of abortions went down spectacularly.” 

Lee P. Shulman, MD:  “Yes.” 

Hans van der Slikke, MD:  “So, this must have been a good thing to do.” 

Lee P. Shulman, MD:  “Well, not to defend nor to chastise but you know it’s clear that even with our counseling, patients are misusing the products.  If you can improve the access to those products, I don’t think in the long run you’ll be, in a sense, providing methods.  Again, you have a pharmacist who is providing, who is going to give some professional information about how to use and how to use properly.  It’s not as though they’re coming to a supermarket and buying it with absolutely no professional intervention.  We’ve got to find a better way of getting these products out and I don’t think the safeguard in this situation of a clinician providing the counseling necessarily insures that that method is going to be used properly and in fact we have very good data that again, one million pregnancies in women using pills the month that they conceive, I think really argues that against that sort of concept.” 

Hans van der Slikke, MD:  “So our main task as clinicians stays to give our patients, consumers, information and then to help them to match the right contraceptive device with them.” 

Lee P. Shulman, MD:  “Educate, empower and support.  Because a method is something that you wouldn’t use or your partner wouldn’t use, doesn’t mean it’s not the right method for that woman sitting in your office.” 

Hans van der Slikke, MD:  “Okay.  Thank you very much for having this interview.” 

Lee P. Shulman, MD:  “Thank you very much.”