The controversial injectable contraceptive Depo-Provera goes "on trial" before a panel of distinguished medical and legal experts in London next week. They will decide whether the drug should be licensed for long-term use in Britain in the face of massive adverse publicity in America, where it has been claimed the drug is dangerous, might be misused and might be given only to poorly educated socially deprived women without their understanding its implications.
The American manufacturers, Upjohn, have fought for a British licence for Depo-Provera, which is at least as effective as the Pill and more reliable than the IUD, cap or sheath, for seven years.
Next week's British hearing has arisen because Kenneth Clarke, the Health Minister, chose as one of his first ministerial actions to overrule the committee on Safety of Medicines which advised him to grant Depo-Provera a full licence for women for whom other methods of contraception were inappropriate. Mr Clarke is believed to have taken his decision because of the risk of women of low social class being given the drug without their informed consent.
One of the hearing's key witnesses will be Dame Josephine Barnes, a former president of the British Medical Association, who will argue that the problems of giving Depo-Provera to women who cannot understand its risks and benefits are no different from those of any drug.
Already, the Royal College of Obstetricians and Gynaecologists and the Family Planning Association have come down in favour of Depo-Provera becoming just another alternative in the choice of contraceptives.
No one is quite sure what will come out the hearing. No drug wrangle has ever reached this stage of the agreed procedures. Kenneth Clarke has already overruled his medical advisors once - he could, in theory, overrule the independent panel's recommendations too.
Upjohn does not stand to make a lot of money out of Depo-Provera in Britain. Around two million women get the Pill from their GP - at a cost of about ú13.5m. According to Dame Josephine, several thousand women who would probably get Depo-Provera if it were fully licensed. But a positive decision from the British authorities would help Upjohn to sell the drug in other areas - such as developing countries - where the market is much larger.
In its 400-page written evidence to the panel, the Coordinating Group on Depo-Provera, composed of women actively involved in women's health issues, has drawn on information it has received about more than 100 women who felt they were not fully informed of the possible side effects of Depo-Provera. Many were women with a poor understanding of English for whom no provision had been made for information to be given in their own language.
Six out of seven women who answered an appeal for women who felt they had been mistreated in one London health district were black and several were young unmarried mothers.
Three years ago one professional singer got an out of court settlement of ú3,750 from King's College Hospital, London, because her career was disrupted as a result of side effects from Depo-Provera which had not been fully explained to her.
The drug has been used most widely in developing countries where there have been many reports especially from Africa and Asia of women given the drug without their fully informed consent and of doctors exceeding their own countries' recommendations of its use.
There was even a report of women in a Cambodian refugee camp being given the drug with the promise of extra food. Even so, the drug is used as part of WHO and International Planned Parenthood Federation contraception programmes.
At present several health authorities including America and Canada are considering whether to license Depo-Provera, after lengthy debate on the medical and social implications. In the past, the US has refused to license the drug for even short term use.
The Coordinating Group on Depo-Provera - the main pressure group against the drug - will not be allowed to give verbal evidence at the hearing. But its comprehensive written evidence would do justice to an organization with much greater resources at its disposal.
Much of the evidence rests on the known side effects of the drug but also raised doubts about the largely unknown long term effects of continued use of Depo-Provera. The group argues that if Depo-Provera is to come on the market at all its use should be limited and controlled so that the terms of the drug's licence are not exceeded.
Upjohn's expert witnesses - a list of whom reads like a Who's Who of obstetrics and pharmacology - will give verbal evidence.
The hearing will be held in the conference suite, Riverwalk House, Millbank, London, SW1, starting on Monday, April 25, 1983 at 10am.
On the panel will be Professor Rosalinde Hurley, chairwoman of the Medicines Commission at the DHSS, Professor A. Asscher, also a member of the Medicines Commission, Ian Kennedy, director of the Centre of Law, Medicine and Ethics at King's College, London, Professor H. Jacobs, consultant gynaecologist and Professor F.A. Langley.
The benefits and side-effects Depo-Provera is a synthetic form of one of the body's natural hormones, progesterone. Each injection prevents pregnancy for at least three months by stopping a woman's eggs developing and by making her womb hostile to any fertilized egg which might creep through.
Since 1978 Depo-Provera has been used in Britain for short-term contraception, which means one, or at most two, injections. Doctors can, and often do, exert their "clinical judgment" and give Depo-Provera for longer periods - for years, rather than months.
There is evidence that Depo-Provera has been misused - given to socially disadvantaged women without full counselling about the drug and its side effects. Its very nature makes it an ideal drug for women who find it impossible to remember to take the pill or use other forms of contraception. A few doctors are thought to have taken it upon themselves to inject such women - often after an abortion or an unwanted child - without explaining the full implications of the drug.
Depo-Provera often prevents a woman from having her normal period. This in itself worries women given insufficient counselling since they think they may be pregnant when their periods stop. In the first months or even up to a year after taking the drug she will have some unpredictable bleeding. Before the injection is given there is no way of knowing whether this will be mild or severe.
Once the injection is given there is no turning back - for the first months the woman must simply "grin and bear it" if she is one of the unfortunate minority who bleeds severely.
Depo-Provera does not cause permanent infertility but women may be slow to conceive after they stop the drug, so it is better kept for women not planning further children. It is often these older women who have a narrow choice of contraceptive methods because their weight, blood pressure or smoking puts them at risk of heart problems if they take the pill.
An enthusiastic supporter of Depo-Provera is Dr John Tylleskar, of the department of obstetrics and gynaecology at the general hospital in Motala, southern Sweden, and also runs his own practice. He believes Depo-Provera is the best contraceptive for women over 35 who do not want more children, and half of his patients in that category use the drug.
Motala is a provincial town with a population of about 30,000 and is far removed from the poor inner cities of Britain when Depo-Provera achieved its controversial status. More than 400 Motala women use the drug, a proportion at least 20 times greater than in the rest of Sweden.
Dr Tylleskar recently surveyed 182 women who first had Depo-Provera in the early 1970s. Some had had a single injection, others had stayed on the drug for 12 years. Four out of five liked the drug, but 22 per cent had stopped it because of side effects. The most common of these were irregular bleeding, weight gain, decreased sex drive and depression.
Since most women who stopped treatment did so within a year of starting Depo-Provera, the survey supported the view that, provided women can cope with the bleeding irregularities in the first months, they generally use the contraceptive for several years.
And what of the benefits? Forty-five per cent of the women in the survey said that not having periods was an advantage, as was the simplicity and reliability of the method.
One woman I spoke to at Dr Tylleskar's clinic, started having Depo-Provera nine years ago after suffering a thrombosis that made it impossible to continue with the Pill. She experienced some bleeding in the early months, but it was not bad enough to make her stop the treatment. A bonus was the disappearance of eczema and migraine from which she had previously suffered.
Two other women had started Depo-Provera because of the risk of circulatory problems with the Pill. One had high blood pressure, the other a family history of heart problems.
The oldest patient Dr Tylleskar had had on the drug was 54. Since there is a tentative theory that Depo-Provera may have a role in protecting women from breast cancer, the doctor believes women should continue to use it even after the menopause.
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