BRITISH BROADCASTING CORPORATION
RADIO SCIENCE UNIT
CASE NOTES
Programme 4. - Contraception
RADIO 4
TUESDAY 20/02/07 2100-2130
PRESENTER: MARK PORTER
REPORTER: CLAUDIA HAMMOND
CONTRIBUTORS:
DIANA MANSOUR
ANNE SZAREWSKI
SAM HUTT
PIERRE BOULOUX
RICHARD ANDERSON
PRODUCER:
ERIKA WRIGHT
NOT CHECKED AS BROADCAST
PORTER
Hello. Today's programme is all about recent developments in the world of contraception.
I'll be looking at the science behind the latest "period free" version of the Pill - Anya. It isn't available in the UK yet but given that Anya doesn't contain anything new - it's the way it's taken that's different - do the three million or so women in the UK using older versions of the Pill really need to have monthly bleeds?
I'll also be finding out why the National Institute for Health and Clinical Excellence believe we are under-using long acting contraceptives like injections and implants - and paying a high price for doing so. Should British doctors encourage more women to follow Nell's example?
NELL
The Implanon is about a four centimetre progestogen rod that is put into your arm. You get a knife cut, an incision, which they then put antiseptic on and they just insert the Implanon under the skin. It's a very, very easy little operation, that takes about two minutes. To me it's brilliant.
PORTER
And, just so you chaps don't feel left out, I'll be talking to two of the doctors at the forefront of research into contraception for men. How close are we to the male pill?
ANDERSON
People have been saying that the male pill will become available in five years or so for a very long time and clearly this is a certain amount of wishful thinking. But the studies that have been done over the last few years really have demonstrated that there is a real possibility.
PORTER
More about whether we really will have a male pill within the next five years later on.
My guest today is Dr Diana Mansour, she's consultant in community gynaecology and reproductive healthcare at Newcastle General.
Diana, let's start with contraceptive pills - two main types - the mini-pill and the pill. What's the difference?
MANSOUR
The combined pill is what most women are taking and that's a pill which has two hormones - oestrogen and progestogen. And both of those hormones make sure that women have a regular cycle and it makes a very highly effective pill. They take it for 21 days and have a seven day break; when they have their bleeding. And it's a highly effective pill if you take it properly.
PORTER
Now the name mini pill - the progestogen only pill - suggests that's it's a sort of diluted version of the pill proper - is that the case?
MANSOUR
Well it's just one hormone - it's just the progestogen hormone which you take on a daily basis, so there's no breaks whatsoever. And there are some advantages, I mean definitely it doesn't have any oestrogen in it, there's synthetic oestrogen, so you can give it to people who may have other medical conditions.
PORTER
But there is a difference in the margin of error when you come to take it and I want to come back to that in a moment Diana.
One of the latest development in this field has been to give women on the combined pill fewer periods. Women on Seasonale have just four periods a year, those on Anya have none. Neither brand is available here in the UK yet. But why, after more than 30 years of development, have the pill manufacturers decided that women don't need a pill free break and a period every month? Anne Szarewski is consultant in family planning at the Margaret Pyke centre.
SZAREWSKI
One of the disadvantages of the breaks is that women get pregnant because the dose of the pill has become so low that if you even prolong that pill free week by a day you can become pregnant. So they want to get rid of those pill free weeks. So that's one reason. The other reason I think is that in the United States, which is the biggest world market, it is almost impossible to do anything that is off licence. So here doctors don't worry too much about saying to a woman - look I know that the product licence says you should stop every month but I'm telling you it's fine to take it continuously. In America doctors won't do that because they're in such danger of being sued if anything at all goes wrong that they simply won't do it. So in America you need to have the product actually licensed to be taken back to back.
PORTER
So although a lot's been made in the media about these new types of pill, in fact really they're just the old pills running back to back.
SZAREWSKI
Yes indeed, the hormones are the same as the ones that have been always been in the pill and it's just that instead of stopping the hormone and having the bleed you just take it continuously and you don't have the bleed. And for a long time already we've said to women, who've had a particular reason for not wanting to have the bleed, you know for example they get headaches in the pill free week or they get particularly painful bleeds or something, for ages we've been saying to them - look you know you don't have to do this, you can just run the packets together. And they go - oh is that safe, is that normal, is that alright? And of course it is perfectly alright because those bleeds are completely artificial and don't have any of the same meaning as a period, they're just there to make you think you've bled.
PORTER
Perhaps we should explain how the pill free week results in a "period" (in inverted commas) because one of the other concerns that the women have is that if they run three packs back to back that the period that then follows that will be three times as heavy.
SZAREWSKI
Ah well that's not true at all and in fact quite often it's lighter because it's not like the blood is building up somewhere and waiting to sort of gush out. When you're on the pill the lining of the womb simply doesn't build up and so you have nothing there to come away. And it's only by stopping the hormones - so it's that withdrawal, that's why it's actually called a withdrawal bleed, because you withdraw the hormones that you're taking - and that suddenly stimulates the lining of the womb to sort of just go wompf build up and then drop off and that's why you get usually a quite light bleed.
PORTER
And with the latest guidelines on the pill, I mean if you're a healthy woman, you're a non-smoker, you don't have any of the risk factors, you can literally take the pill from your teens right through until your late 40s or even until you're 50.
SZAREWSKI
Yes up to 50, as long as you don't smoke, as you say, and you don't have risk factors for heart disease.
PORTER
Is there any group of women who wouldn't be suitable for running pills back to back or are they exactly the same as a woman who'd be suitable to take any form of pill?
SZAREWSKI
There's really no woman who wouldn't be suitable, which doesn't mean every woman is successful at doing it because you need to sort of tailor it to some extent because not all women will be able to run packets back to back for the same length of time and not all pills are as successful to do that with. So, for example, you can't do it with the so-called phasic pills, where you have different doses of hormones throughout the month. You can't do it with them because once you start running them together you just get breakthrough bleeding anyway. Also some pills just don't have the sort of balance of hormones that allows you to keep going, you'll just get breakthrough bleeding. So I think you do have to be sure that it's a type of pill that is quite kind of good for running together. And then you'll also find that for the majority of women they can't go forever without bleeding. And so that's why I think the three monthly cycle is quite popular because a lot of women can do three packets.
PORTER
When you say they can't do it you mean that even if they were to run the pills back to back they would get some bleeding?
SZAREWSKI
They start to get breakthrough bleeding and then they get worried because they don't understand quite why it's happened and so on and so I often say to women actually just take your pill until such time as you start to get breakthrough bleeding and then you'll know that you need to have a break at some point soon, doesn't have to be straightaway because it's not dangerous that you're getting breakthrough bleeding, it's just a real nuisance. So, for example, if you know this week when you started to get your breakthrough bleeding you know this is a bad week to have a bleed just keep going for another week and then have your break because the problem is that generally speaking they'll just carry on bleeding until they do have a break. So it's nice to have the break and then stop bleeding again. And once they've done that it'll usually be the same length of time for each individual woman, so she can sort of tailor it to her own body.
PORTER
Anne Szarewski talking to me earlier.
Diana, just to clarify: we're talking about the combined contraceptive pill - the pill, not the mini-pll, and while it is perfectly acceptable for a woman to keep running packs of the existing brands of the pill back to back, you should check with your GP or family planning clinic first to make sure that you're on the right sort of pill.
MANSOUR
Absolutely.
PORTER
Well one problem with all types of pill of course is that you have to remember to take them. What sort of margin for error is there with the conventional pill?
MANSOUR
Well with the conventional pill you've got - well we normally say 12-24 hours but we'll stick to a 12 hour rule and most women can normally remember to take something within 12 hours. Saying that, however, we will always quote perfect failure rates, from studies that have been done with perfect women who remember their pills. And so perhaps one woman out of a hundred would get pregnant using these pills. In practice well ...
PORTER
The real world.
MANSOUR
... we've found out that we miss on average about three pills a month. So you can imagine that when you actually look at real life figures it's about 1 in 20 women over a year will get pregnant.
PORTER
So if 20 women take the pill for a year, one of them will get pregnant?
MANSOUR
One of them will get pregnant.
PORTER
That's a pretty high - and presumably - is it worse for the progesterone only pill - the mini pill?
MANSOUR
For most POPs - progesterone only pills - yes you're supposed to take them within three hours. There is one, however, where you've got a 12 hour window and that would appear to have the same failure rate or safety efficacy rate as the combined pill.
PORTER
But still I mean I think a lot of people will be surprised that the failure rate's that high in the real world. One of the ways round that of course is to use a longer acting form of contraception. Recent guidelines from the National Institute for Health and Clinical Excellence suggested that we under use those methods in the UK, things like injections, implants and intrauterine devices. Why do you think that is?
MANSOUR
I think there's two things: it's looking at it from the users view or the professionals, the health professional. From a woman's point of view I think there's been lots of myths out there. We worry that these particular methods are dangerous, they're going to give us infections, they're going to make us infertile, they're going to bring on an earlier menopause. That if we've got, say, an implant nobody can get it out; if we've got an intrauterine device, it goes wandering around our bodies. I mean there's all sorts of myths that were around when I was a youngster and are still there.
PORTER
I mean in practice when you mention these to women you often see they curl their lip sometimes, don't they, and say well I'm not sure that's for me, I think I'll stick to the pill. What about professionals from the other side of the desk - they often get things wrong too don't they?
MANSOUR
Well yes I think they do and it's really our role to not only educate users but actually educate ourselves. And things are changing fairly rapidly. We know that not all nurses, doctors can provide all these methods but there certainly should be within each large local area expertise to be able to offer these to all women. Often these are seen to be expensive, although of course they do prevent pregnancy and overall they're actually more cost effective than women being on the pill over a year.
PORTER
Well with five years before it needs to be changed, the intrauterine system Mirena is one of the longest lasting of the long acting contraceptives. And, unlike other types of intrauterine device or coil, it has a useful side effect too. As Claudia Hammond discovered.
HAMMOND
It's been called the best kept secret in contraception. It's a T-shaped piece of plastic, less than two inches long. It lasts five years and it's 20 times more effective in preventing pregnancy than the pill. And you can have one fitted whether you've had children or not. Sounds too good to be true, so to find out exactly how it works I went to see this man.
MUSIC
Professional musician Hank Wankford there but when he's not singing country and western he's Dr Sam Hutt, a specialist in contraception and reproductive healthcare at the Margaret Pyke Clinic in London and in his time he's fitted hundreds of Mirenas.
HUTT
It has a little what is called silastic membrane which is filled with progestogen which is the synthetic copy of progesterone. And the silastic membrane is very clever because it'll deliver a metered dose of so many micrograms every day to the lining of the womb.
HAMMOND
How does it actually prevent pregnancy - is it the hormones that are preventing that?
HUTT
Well it's the hormone that affects the endometrium, which is the medical word for the lining of the womb, and it makes it thinner. The other effect is that the progestogen actually affects the little plug of mucus that you have in the canal of your cervix. With the Merina in that little plug stays very, very thick and sort of impenetrable to the sperm. So in a funny way it's like having a biological cap preventing the sperms getting in in the first place but if they do get in and they do get to the egg, the egg has not got a lot of chance of implanting.
HAMMOND
So you will still ovulate as normal then, if there's still an egg there?
HUTT
For the most part yes but some people will get affected by the progestogen, affecting their ovaries and may even stop them ovulating.
HAMMOND
And so does that mean that it has fewer side effects for people than the pill which is stopping people ovulating?
HUTT
Absolutely right. If I were talking to a woman who wanted to have intrauterine contraception I would centre pretty much on what her periods are like. If she has four, five day long periods, moderate flow, not heavy, not painful, basically easy then we would probably go towards the copper IUD, which will tend to make your periods heavier and longer. If you say at the first consultation - ah I've got seven day long periods and it's the curse and it's awful - that's when a Mirena is going to come into its own because that's going to decrease your amount of bleeding. And also, as it happens, make it less painful.
VOX POPS
I'd had very heavy periods before kids and then very, very heavy periods when my periods came back and it was very nice to get back to a light cycle but certainly I didn't get the PMT that I'd had on the pill before I'd had children.
For the first few months the spotting occurred quite a lot, maybe for a few weeks at a time when it happened, I think I had a check up after six months where maybe I thought about having it taken out but they told me to persevere, so I did, and I suppose after about six months it really started to settle down.
HUTT
Do be prepared that you will possibly get this spotting and some greasy skin and breast tenderness for a few weeks at the beginning and it goes for most people.
HAMMOND
Because when you look at the list of side effects, and I know that you know they have to list everything and some of them are presumably much rarer than others, I mean there are all sorts of things like unpredictable bleeding, acne and even possible perforation of the uterus putting it in, I mean presumably some of these things are very rare are they?
HUTT
Thankfully perforation of the uterus is fairly rare, it's of the nature of something between 1 in 1-2,000. The irregular bleeding is probably the most difficult thing for people to deal with and that is a problem. The other thing is that it can go the other way - you can finish up having no periods at all.
HAMMOND
And what about having it put in, I mean this is the other thing that worries people of how much it will hurt, particularly if they haven't had children, is it going to be agony?
HUTT
Many women can have it fitted with no more than like a period cramp. For some people it is the - and I quote - "the worst pain I have ever had in my life". When you put something through the cervix there is a whole range and I've often had the experience where I've fitted a Merina on nalip [phon.], on a woman who's never had babies, no problem and then the next person has had three kids and I measure inside and they go ahh and has to have the local. And some cervixes feel pain and some don't.
VOX POPS
I don't feel any side effects from it that I'm aware of. It doesn't interfere - I can't feel it, my husband can't feel it. I don't have periods anymore, which is wonderful. It's safe and I can just forget about it, so you don't even have to worry about contraception.
I found sex slightly uncomfortable with it, and my husband said he could feel it. It was never painful, it's just, you know, it was just - I was aware that something was there all the time. But then I went in to tell my doctor that I wanted to have the Merina out, so I was lying on the couch having a smear and what had happened was the coil had actually fallen out during the smear test and she had had it in her hand afterwards. So it obviously hadn't been in for a while so I'm very lucky I wasn't pregnant.
HUTT
You've got this round about 10% chance of it coming out and if it lies in the low part of your womb your womb won't like it. So that was her problem for that. I would say that the majority of people I think are happy with the Merina especially people who have menorrhagia and menorrhagia is the medical word for excessive bleeding.
HAMMOND
Now I understand all about the Merina but I still find it hard to believe that this doctor could be one and the same man as Hank Wangford. But judging by the number of Stetsons in his flat I think it must be true.
MUSIC
PORTER
Hank Wangford - aka Dr Sam Hutt - ending that report from Claudia Hammond. You are listening to Case Notes . I'm Dr Mark Porter and I am discussing developments in contraception with my guest Dr Diana Mansour.
Diana, we heard there that the Merina can be used in women of all ages, the traditional teachings, certainly when I was at medical school, was that we wouldn't use an intrauterine device or coil or Merina in somebody who hadn't had a child, what's the thinking now?
MANSOUR
Well I think we've changed our views quite a lot and in fact there's been work in Finnish women showing that it's very acceptable in women who haven't had children.
PORTER
What about the implant and injection - they use the same type of hormone as Merina but don't last as long?
MANSOUR
That's right. Well the implant is fitted normally in the inside of the upper arm and will last for three years, of course it can be taken out before then, and is highly effective, I mean you occasionally get failures but it really is very, very effective and can be taken out at any stage. The injection, you need to give that every 12 weeks, and that's normally into a muscle, normally into the bottom ...
PORTER
Into the bottom yeah. And presumably once that's gone in, of course, you can't do anything about that?
MANSOUR
No, and the thing is although the contraceptive action will last about 12 weeks if you have more injections you tend to get less bleeding and in fact many women get no bleeds after a year but it takes time to wear off as well and so they can get erratic bleeding as it's wearing off.
PORTER
But if you have a - if you're on injections for a couple of years or you have the implant for a couple of years and you want to then start a family how long would it take to return to normal fertility - roughly?
MANSOUR
Well with the implant and as we've heard with the intrauterine system - hormonal system - it's immediate - as soon as you have it removed you start to ovulate and you're ovulating normally within the next month. With the injection it can take on average up to about six months before you start to ovulate.
PORTER
What about concerns about side effects? The one that I read about but I'm not so sure about is bone density - that by stopping women - they don't have periods on the injection, for instance, and that this can affect their bone density, make them more prone to get osteoporosis later in life, a concern if you're giving it to very young women - where do you stand on that?
MANSOUR
Well in fact - I mean a number of these methods - the mini pill, that we've talked about, the IUS, the injection, the implant - can all cause no bleeds in women, it doesn't give a regular monthly bleed but a lot of women like that. The real issue is really with the injection, not with the other methods, because with the other methods you're still producing some oestrogen from your ovaries, which protect your bones. In fact with the injection there isn't really any evidence it causes osteoporosis, it's one of these sort of myths again that's out in the medical population as well as amongst users. It does in studies suggest that you have a reduction in bone mineral density, so the bones aren't as thick when you're using it, about the same as if you were breastfeeding for a year but it's recoverable. And there are papers around looking at women and their bones at the menopause, comparing those who've used the injection compared to non-users, and the bones are exactly the same.
PORTER
Okay. So far we have concentrated on hormones for women, but what about hormones for men? British researchers may now be at the forefront of the race to develop an effective male contraceptive but the concept is far from new. Richard Anderson is Professor of Clinical Reproductive Sciences at the University of Edinburgh.
ANDERSON
The potential use of steroids to suppress men's sperm production has actually been around for a very long time, the first scientific study I know of was back in the mid-1930s, which predates any female methods. And then the first sort of proper scientific studies compatible with what we would now be doing again go back to the early 1970s. So these methods have been around for a very long time but have only latterly been taken up by industry and that's really what's going to provide the momentum needed to take it forward into the market place.
PORTER
Often referred to as the male pill, one of the most promising versions actually uses a combination of an implant and injections - two types of hormone: progestogen and testosterone. A method that Pierre Bouloux, Professor of Endocrinology at the Royal Free Hospital, has been helping to develop.
BOULOUX
The average Joe Bloggs who's healthy has anything from 150 to perhaps 400 million sperms per ejaculate and the idea was to try and get the concentration of sperm down to less than one million per mil.
PORTER
You're delivering these drugs how?
BOULOUX
So the progesterone like drug was given as a small rod, which was implanted under the skin on the inner aspect of the arm, that was done under local anaesthesia and it's about two and a half inches long, it's flexible, it was slid under the skin so that the vast majority of men could feel it under their skin, and it's reassuring, they know where it is, and that's delivering the progesterone like drug. And the idea behind that is that it switches off the pituitary gland production of the two key hormones which are essential for sperm production - one called LH and FSH. As a consequence of which the testes stop producing sperm but also stop producing the male hormone testosterone. We don't want that to happen of course, so we had to add back testosterone. That was done by an injection at intervals of around 8 to 12 weeks. And the study showed very elegantly that within three months we achieved the primary objective of the study which is to switch the sperm to less than one million per mil.
PORTER
How well was it received by the men, what sort of side effects were there?
BOULOUX
They were weight gain, there was a proportion of patients who complained of mood changes, some individuals got a bit of acne...
PORTER
Did you get any structural changes in the testes themselves, do they shrink?
BOULOUX
Yes, I think when - that is a predictable side effect when you give somebody a drug which switches off LH and FSH, which are the two key hormones from the pituitary gland that normally maintain the volume of the testes. The bit I haven't mentioned is what about the recovery. Within three months of stopping the combination 60-70% had already regained sperm concentrations to what they were like prior to the treatment and the vast majority were back to normal within six months. So it's clearly reversible and I suspect that we have not reached the point where we say that this is the best combination of hormones. I think it's going to take 5-10 years before we really have these products on the market.
PORTER
How well do you think it would be received by the population here in the UK in general?
BOULOUX
With respect to acceptability in men, and also women I suspect, it would be nice to have a treatment that only had to be given for example once a year as opposed to one which you would have to have regular treatments. In terms of the type of person who's going to most likely come forward - I suspect it'll be a person who has completed his family, who's very sensible, and in whom perhaps there may be contraindications with the use of the pill and other forms of contraception in his wife.
ANDERSON
If you say to a woman - do you trust men in general then she's quite rightly going to say no but if you ask a woman - do you trust your partner to take a pill, the man who you sleep with every night, the man you bring up your children with, the man you share a bank account with, then you get a different answer. And indeed when we did a survey of best part of 2,000 women attending family planning clinics locally we found that almost all the women said they would trust their partner to do this. There were a few who wouldn't but the vast majority did.
BOULOUX
I think it's a cultural thing because everybody's thought of contraception as being largely the female domain with the exception of condoms of course and abstinence - the best form of contraception. But in general terms I think this is a message that has got to be put across. So I think that the male population isn't prepared for that yet.
ANDERSON
You only have to go back a couple of generations to remember that in say our grandparents or great grandparents days the only contraception available was male methods, which were condoms and withdrawal, so really we've seen a huge change towards the female methods that have become so dominant since the advent of the pill 40 odd years ago. And that's such a rapid change I see no reason why a little bit more of a middle ground couldn't be reached. And indeed in that survey I mentioned the main reason that women would trust their men to take the pill and were interested in that is that women were feeling that they were taking the whole burden of contraception on themselves and it was about time that that was a more shared experience.
PORTER
Professors Richard Anderson and Pierre Bouloux talking to me earlier.
Diana, you're the one working in family planning clinics - where do you see a male pill or male contraceptive fitting in, if at all?
MANSOUR
Well I always think it would be nice that men took their role in contraception and for many of them yes condoms are okay but they do fail and otherwise you've got vasectomy. So yes it would be good to have an option, if it was pill, I'm not so sure men would be so keen to have implants and injections and having to take a few months before it works - I've never known a man wait for anything. So I'm a little bit cynical and it's been 10 years off for the last 30 years and yes we're going to have wait, aren't we.
PORTER
You're not holding your breath though?
MANSOUR
I'm not.
PORTER
Okay. Briefly I want to end with a reminder about emergency contraception - so far we've concentrated on obviously the ideal thing - that's to prepare and prevent unplanned pregnancy in the first place. But what happens - what can we do to help people after the event, if you have an accident because accidents do happen?
MANSOUR
Oh they do and unfortunately we see the results of those actions and 180,000 or more women actually have terminations each year. And many of them feel they weren't going to get pregnant and they do. Women often aren't aware of emergency contraception or where to get it or that they should have something in the bathroom cupboard just in case they have an accident - if they miss pills or if they have accidents with their condoms.
PORTER
So what is available - we've got the so-called morning after pill?
MANSOUR
We've got a particular progestogen only hormonal type of pill that you take as a one-off dose within three days, 72 hours, of having the accident.
PORTER
What happens if you've gone on longer than that?
MANSOUR
Well there's a bit of evidence it will still probably work up to five days and many of us would actually give it out up to five days. But what's more effective is having a copper intrauterine device fitted, that's almost a hundred percent because even with the hormonal version there is a point in your cycle where it doesn't work and that's when you've had the trigger to ovulate. So if you're unfortunate enough to have had unprotected sex just after this trigger and when you're about to ovulate ...
PORTER
Mid cycle for most women roughly.
MANSOUR
Mid cycle - you are likely to get pregnant.
PORTER
So you should seek expert advice and that's ...
MANSOUR
Seek expert advice and there are more effective options, such as a copper IUD, to be fitted.
PORTER
So GP or family planning clinic and up to five days in the case of the copper IUD.
MANSOUR
Absolutely.
PORTER
Diana Mansour than you very much, we must leave it there. Don't forget you can hear any part of the programme again by using the Listen Again facility at out website at bbc.co.uk/radio4.
Next week's programme is all about blood pressure. At least one in five British adults is thought to have worryingly high blood pressure - and more likely than not blissfully unaware of the problem. I'll be finding out why high blood pressure is so important. Who should be tested and how including a look at DIY devices for use at home and talking to one of UK's leading authorities about the latest thinking on treatment.
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