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New Contraception Options
Lee P. Shulman, MD, interviewed by Hans van der Slikke, MD
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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.”
