It was the first lifestyle drug, launched against fierce opposition from the moral right, which revolutionised social and sexual attitudes and helped define the 1960s. Now, almost 50 years on, it is to be made available over the counter without a prescription.
Another milestone in the history of the contraceptive pill was signalled last week with the disclosure that, from the New Year, pilot schemes in two south-London primary care trusts, Southwark and Lambeth, will, for the first time, allow pharmacists and nurses to provide it to women over the age of 16.
The aim is to test whether making the Pill more easily accessible reduces unwanted pregnancies. Pharmacies are open for longer hours than GP surgeries and do not require an appointment or have long waits. The Family Planning Association said that it received scores of calls from women who had run out of the Pill and didn't know where to go to replenish their supply in the evenings or at weekends. Britain's teenage-pregnancy rate remains the highest in Western Europe (though it is falling in many areas) and difficulties with access to contraception are believed to be a key factor.
The Pill is now considered so safe and its use so routine, that the involvement of a doctor is no longer required. Half a century ago, a very different attitude prevailed...
The beginning – early skirmishes
The Pill was licensed in Britain in 1961. Women who desperately wanted it fought a tense battle with the religious, state and medical authority figures who tried to stop them getting it. One group of provincial doctors accused a colleague of "undermining the reputation of the medical practice in the neighbourhood as well as the morals of the public at large". A Catholic scientist condemned contraceptive users as "ignorant of the fact that sustained happiness comes only from dutiful sacrifice". By contrast, the poet Philip Larkin celebrated the changes it wrought with the immortal line, "Sexual intercourse began in nineteen sixty-three". Credit for the discovery is usually attributed to Carl Djerassi, the Austrian chemist (also a novelist and playwright) but several others were involved in its development.
The Pill gave women unprecedented control over their fertility, and it did not interfere with spontaneity or sensation. For the first time, sex became an act that women could enjoy on an equal footing with men. But feminists who grew up in the 1960s have more recently claimed that it was a "misogynist tyrant in disguise", urging women to be ever more available for male pleasure, and pumping their bodies full of chemicals.
The medical revolution – Has it increased happiness?
It was the first prescription drug to bring large numbers of healthy young women into doctors' surgeries, launching the era of preventive medicine and screening, as Lara Marks observed in Sexual Chemistry: A History of the Contraceptive Pill, published in 2001. It allowed women to control their bodies and plan when to have children with a reliability of which previous generations could only dream. But the consequences that have flowed from that – delayed childbearing, the huge increase in women going out to work, an obsession with perfect sex, and the rise in infertility have led some to question whether it has increased or diminished human happiness.
Today, more than 3.5 million people in the UK use the Pill, and 300 million are estimated to have used it worldwide over the past four decades. Not all societies were impressed, however. In Japan, fears that it would lead to an increase in sexually transmitted diseases (due to reduced condom use) prevented it from being approved for almost 40 years. It was finally licensed there in 1999, and only 1 per cent of Japanese women of childbearing age use it, compared with 25 per cent in the UK.
Is it safe? – risks and benefits
From the start, fears about the long-term effects of the Pill dominated medical debate. Few drugs are taken daily for years by healthy individuals not suffering from any medical condition. In those circumstances, a guarantee of safety was paramount. The Royal College of General Practitioners established a research project in 1968 with one of the largest databases in the world. Its latest report, published in 2007, 39 years later, found that far from causing cancer, as long suspected, the Pill provides protection against it.
The results, published in the British Medical Journal, showed that it caused a small increase in cervical cancer but this was outweighed by reductions in ovarian, womb and bowel cancer, for women who had taken it for up to eight years. Women who used it for longer had a slightly increased overall risk. There was no effect on breast cancer. Professor Valerie Beral, head of the Cancer Research UK Epidemiology Unit at Oxford University, estimated, in The Lancet earlier this year, that the Pill had saved 100,000 lives from ovarian cancer worldwide, because of the huge number of women taking it. An earlier study by Professor Beral showed that taking the Pill was linked with a slight increase in breast cancer, but this returned to normal 10 years after stopping it. The Pill does carry a small risk of triggering blood clots (thromboses) and of causing heart disease and stroke in women who smoke or have high blood pressure and are over 35. These women are advised to avoid the standard combined pill containing oestrogen and progestogen, and opt instead for a progestogen-only pill.
The impact on women's sexuality
Young single women have always had sex – statistics show that in 1875, 40 per cent of brides were pregnant on their wedding day. What changed with the advent of the Pill was that they were able to enjoy sex for the first time.
The effect has been long-lasting. Those who were in their thirties during the sexual revolution of the 1960s still retain a liberal attitude to sex now that they are in their seventies, four decades later. A Swedish study published in the British Medical Journal earlier this year found that septuagenarians were having better sex, and more of it, than ever before. It was the women who were particularly satisfied with their sex lives, more so than the men.
But for some women, the Pill triggers mood swings, health problems and sexual difficulties. Scientists say that these women have lower levels of testosterone – the male hormone, also present in women, which affects the libido. A study published in the Journal of Sexual Medicine suggested that the Pill suppressed the hormone both directly and through suppression of ovulation in a "double hit", and warned that GPs should consider this physiological effect of the drug before assuming that a woman's sexual problems were psychological.
Several studies over the last 30 years have claimed to show a link between the Pill and loss of sexual desire in certain women. But the Family planning Association said that there were many other confounding factors, such as the nature of a woman's relationships, and it was impossible to tell if the association was cause and effect.
The end of menstruation
The Pill works by turning the ovaries off so that they stop producing eggs. This means that the regular bleed that women on the Pill have each month is not a genuine menstrual period, but a fake. When the Pill was first introduced in the 1960s, it could have been designed to eliminate the monthly bleed. But there were no simple pregnancy tests available and scientists believed that women would want the reassurance of a regular period as proof that they were not pregnant. And with church leaders railing against it, drug manufacturers felt that to mimic the natural monthly cycle as closely as possible would make it more acceptable.
As a result, women on the combined pill take it for three weeks followed by a seven-day break when they have a "withdrawal" bleed – not a genuine menstrual period. (Women on the progestogen-only pill take it continuously but have a similar regular monthly bleed).
Doctors say that there is no reason why women on the Pill should continue to suffer the pain, discomfort and misery of menstruation. The bleed that they have is not natural and the idea that menstruation is normal is wrong (throughout history, women have been pregnant or breastfeeding or post-menopausal, so didn't have periods). Some gynaecologists admit to personally taking the combined pill continuously to put an end to menstruation.
In the US, a contraceptive pill, Lybrel, launched last year, is the first that is recommended for taking 365 days a year, to eliminate periods altogether. Its makers, Wyeth, have applied to launch it in Europe under the brand name Anya.
A male pill soon?
In your dreams. Surveys suggest that women would be enthusiastic about handing over responsibility for contraception to men – especially if it were guaranteed by a hormonal implant under the skin. But progress is frustratingly slow. A key difference between the male and female reproductive systems is that while in women it works like clockwork, producing an egg each month, in men it is continuously producing sperm. Interrupting the male reproductive system without affecting the libido presents a greater, and so far unsolved, challenge.
Freedom years: The Pill's breakthroughs
1954
Dr Gregory Pincus and Dr John Rock begin trials on 50 women of the drug that would later be called Enovid, the first oral contraceptive pill.
1957
It is approved by the US Food and Drug Administration (FDA) in 1957, but officially is only licensed to treat medical problems, not for use as a contraceptive.
1960
The FDA allows Enovid to be sold as a contraceptive pill.
1961
The pill is first licensed in the UK.
1967
12.5 million women worldwide use the Pill.
1968
On 25 July, Pope Paul VI condemns the use of artificial contraception in an encyclical, Humanae Vitae.
1984
Emergency hormonal contraception (known as the "morning-after pill"), which can prevent pregnancy up to 72 hours after intercourse has taken place, is licensed for use in the UK.
2001
Women can buy emergency contraception without a prescription.
2007
A report from the Royal College of General Practitioners finds that, overall, the Pill protects against cancer.
2008
On 1 October, Sarah Palin states she "would not choose to participate in that kind of contraception".
On 12 December, the Vatican condemns the use of the morning-after pill.
BUT (still in Britain)
Doctors and health professionals are "duping" thousands of women by only offering them a limited range of contraception that does not include alternatives better tailored to their health and lifestyle needs.
Health experts say clinicians are sticking to "old favourites" of brands of contraceptive Pills, which are cheaper to prescribe than "designer" Pills.
The Family Planning Association (FPA) says that, as a result, many women are forced to put up with painful periods, water retention and problem skin because their contraception is not being tailored to alleviate these symptoms, which in some cases could be helped by new style Pills.
The majority of women still bear the responsibility for contraception, but clinicians are not making their patients properly aware of long-term protection such as implants and hormone-releasing devices (IUS) because these require specialist expertise to fit.
The FPA warns that women are at risk of unwanted pregnancy because they are prescribed contraception that does not suit their lifestyles. They end up ditching it altogether rather than facing the embarrassment of demanding something more suitable.
This month, the National Institute for Health and Clinical Excellence(Nice), the body responsible for providing advice to the NHS, is expected to tell GPs and clinics that they need to offer women more choice, especially with products that offer long-term protection, and that clinicians need more training in how to fit these devices.
The Royal College of Obstetricians and Gynaecologists, which sets standards to improve women's health, is to publish evidence in November highlighting the lack of contraceptive choice for women.
From hormone implants to the rhythm method, there are currently as many as 14 different types of contraception on offer to women in this country. With the Pill alone, there are now 23 different brands available, each suited to women's individual lifestyles and medical histories. For example, Yasmin, a "fourth-generation" Pill reputedly aids weight loss.
Another product, Mirena, an intrauterine device that pumps hormones directly into the bloodstream, has been shown to reduce heavy bleeding and therefore the need for women to undergo hysterectomies.
Yet official figures indicate that clinicians are failing to tailor contraception to their patients' needs and are sticking to old favourites that are also cheaper. Despite the wide range of products available, the condom and the Pill account for nearly half of all contraception used by women aged between 16 and 49, a figure that has remained relatively constant for the past seven years. The most commonly prescribed type of Pill is Microgynon, which was developed in the 1970s and accounts for nearly half of total sales. "New generation" brands are used by less than a quarter of women on the Pill.
The popularity of some "designer" Pills has declined partly because of health scares about the risk of blood clots, but experts say the real reason they are not being widely used is because they are more expensive than older brands.
An investigation by The Independent on Sunday found that some clinics were failing to tell women about the choices available. One clinic in north London visited by an IoS reporter did not have the facilities to offer a proper check-up and did not offer any explanation about the different types of contraceptives available.
The nurse there was vague about contraception that offers long-term protection against pregnancy and suggested that the Pill was the best option. At one point, she became angry when our reporter suggested that she was planning to get a second opinion about the most suitable type of Pills on offer.
Another clinic, based at a London hospital, was better equipped to advise patients. The senior nurse there pointed out that GPs often did not have proper sexual health training to fit devices such as IUDs, which have to be placed within the uterus. She did suggest that the contraceptive patch may be suitable but admitted that the clinic had limited resources and did not normally tell patients about the patch.
The FPA said increasing numbers of callers to its helpline were complaining that they were not being offered enough advice from their doctors or from clinics.
"There are a few favourites [Pills] - the cheaper ones - that get picked over and over again," said Toni Belfield, from the FPA.
"Women should have the choice to be able to tailor contraception throughout their lives but they are not doing so. It is well recognised that women are not told about longer-lasting contraception methods."
Bea Hodgkin, who works in publishing, wanted a natural method of contraception but spent three years on the Pill because her doctors were reluctant to prescribe the coil.
The 25-year-old, who lives in west London, said she has friends who have had similar experiences where they have not been told about or offered more choice over the type of contraception they use.
"With the Pill, I didn't like the thought of having hormones that meant I was not in control of my emotions," explains Ms Hodgkin, who eventually persuaded her clinic to fit the coil.
"But I would say they actively discouraged me from getting it [the coil]. They're really reluctant to give it to people who are not married or don't have kids, and they thought I was too young."
Only around eight per cent of women use a long-acting method of contraception, an issue that health experts say needs to be investigated.
Dr Anna Glasier, from the Royal College of Obstetricians and Gynaecologists, said that women can expect to require contraception for at least 30 years of their lives, and that their changing needs during this time needed to be properly addressed.
"There is a feeling that the low uptake of long-acting methods of contraception is because they are not easily available," said the director of family planning at Lothian Primary Care NHS trust.
"It's women who bear the brunt of contraception but often the benefits are not stated clearly enough. "
Additional reporting by Sara Newman and Hannah Swerling
The five pills GPs like most
Microgynon: Most commonly prescribed. Like all "combined Pills" contains oestrogen and progestogen. NHS cost £2.82
Cilest: Very popular. £8.57
Ovranette: Can help women with heavy periods. £2.46
Marvelon: Combined Pill whose use fell briefly after scare. £6.70
Yasmin: Advert claiming it helped weight loss was withdrawn. Ensuing media attention ensured popularity. £14.70
Pills they don't push
Ovysmen: May reduce acne, period pains and premenstrual symptoms. NHS cost £1.70
Binovum: 21-day course Pill. £2.24
Brevinor: Has far lower doses of oestrogen than early Pills. £1.99
Loestrin: A low-dose Pill for older pre-menopausal women. £3.93
Logynon: Pack includes "dummy" pills for the forgetful. £3.92
Norimin: Unsuitable for women with high blood pressure. £2.28
Noriny: Recommended for women with epilepsy. £9.98
Synphase: Low on oestrogen. NHS cost £3.60
Trinordiol: Comes in three different strengths, with the highest one the week before the period. NHS cost £4.34
Trinovum: Low dosage increases throughout the monthly cycle. NHS cost £3.11
Mercilon: Contains hormones desogestrel or gestodene. £8.57
Femodene: Subject of recent failed lawsuit claiming that users developed blood clots. £6.84
Minulet: New low-dose combination Pill. NHS cost £6.84
Tri-Minulet: Suitable for heavy or painful periods. £9.54
Dianette: Often prescribed to teenagers. £3.70
Microval: Contains only progestogen, so ideal for women with history of blood clots. £1.89
Femulen: OK for nursing mothers. £3.31
Almost 60 years after the development of the Pill, scientists have announced they are working on the first alternative oral contraceptive, and they hope it will be free of side-effects.
Instead of controlling the woman's monthly cycle, the new drug would work in an entirely different way by targeting a gene that controls female fertility and it would be completely reversible.
Unlike the existing Pill, it would not contain hormones and scientists hope it would have far fewer adverse effects. It could be delivered through a patch on the skin which would need to be worn for only a few days each month, when the woman was ovulating. Women who take the Pill complain of mood swings and nausea and are at higher risk of blood clots and high blood pressure. The Pill contains small doses of the hormones oestrogen and progestogen which block ovulation but cause side-effects.
The new contraceptive, which is in the early stages of development, would avoid these side-effects because it does not depend on manipulating hormones.
Instead it would allow ovulation to occur as normal but would prevent the sperm penetrating the egg by targeting a gene called ZP3. Blocking the gene prevents production of a protein that forms part of the coating of the egg which enables sperm to bind to the outer layer. The technique is based on RNA interference, which targets specific genes.
Dr Zev Williams, of Brigham and Women's Hospital in Boston, presented the findings at the American Society for Reproductive Medicine conference in Washington. He said trials on humans were a decade away and the drug had only been tested in mouse and human kidney cells. But the results had demonstrated "proof of principle" showing that it worked. "Mice that have ZP3 knocked out are infertile. They just don't get pregnant. If you could block this in women, you could prevent pregnancy from occurring. Our work is a proof of concept, in cell culture."
Dr Williams said there were only three kinds of contraceptive – hormones, IUDs and barriers – and there was an obvious need for a wider choice. "Since the 1950s we have had the entire biomolecular revolution in medicine, and yet these three options are still all there is. We simply don't have a contraceptive drug that is non-hormonal and reversible. What we are trying to do is to think about contraception in a new way. Obviously there are going to be big hurdles and it is going to take a lot of time, but the need is there and we think it can be achieved."
Some women derive benefit from the hormonal effects of the Pill because it regulates their monthly cycle or reduces menstrual pain. "But for women who use the Pill just as a contraceptive, a non-hormonal approach would be wonderful," Dr Williams said. "You could get all the benefits without the nausea, the headaches, the mood alterations, and the raised risk of thrombosis, stroke and heart attacks."
Andrew Sharkey, senior research associate in the Department of Pathology at Cambridge University, said: "The advantage of ZP3 is that it doesn't occur anywhere else in the body, so the effect is highly targeted. You can get weight gain with oestrogen and some pills have an effect on libido and mood and every woman has a different response. The oral Pill is nearly 60 years old and there has been no real advance since then."
How the process was discovered
RNA interference – which means, in scientific terms, silencing, or quelling – came about originally through experimentation among plant researchers during the 1990s. Although the aim was to produce darker flowers, what emerged were almost entirely white flowers, less pigmented and – crucially – indicating that 'chalone synthase' had been significantly decreased. It was used on other organisms such as worms and fruit flies, and in 1998 a paper in the journal Nature by the scientists Craig C Mello and Andrew Fire, introduced the concept of gene silencing and they won the Nobel Prize in 2006
(my bold formatting)
Pill thought to disrupt instinctive mechanism that brings together people with complementary genes and immune systems
The pill is thought to disrupt an instinctive mechanism that brings people with complementary genes and immune systems together.
By passing on a wide-ranging set of immune system genes, they increase their chances of having a healthy child that is not vulnerable to infection.
Couples with different genes are also less likely to experience fertility problems or miscarriages.
Experts believe women are naturally attracted to men with immune system genes that differ their own because of their smell.
The major histocompatability complex (MHC) cluster of genes, which helps build proteins involved in the body's immune response, also influences smell signals called pheromones.
Although pheromones may be almost unnoticeable at a conscious level, they can exert a potent effect.
A man's pheromonal odour is partly determined by his MHC. From a woman's point of view, a man with an alluring smell is also likely to have suitable immune system genes.
The new research provides evidence that the contraceptive pill can upset this process.
Researchers asked 100 women to sniff six male body odour samples from 97 volunteers and say which they preferred, with tests carried out both before and after the women had started taking the pill.
"The results showed that the preferences of women who began using the contraceptive pill shifted towards men with genetically similar odours," the University of Liverpool's Dr Craig Roberts, who led the study, said.
"Not only could MHC similarity in couples lead to fertility problems, it could also ultimately lead to the breakdown of relationships when women stop using the contraceptive pill, as odour perception plays a significant role in maintaining attraction to partners."
Being on the pill simulates a state of pregnancy, which may reverse a woman's reaction to male odours.
Finding particular men sexually attractive is not so important once a woman is expecting a child.
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