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Contraception
   
  Advice on pill safety that led to the 1995 pill scare is reversed
By Maxine Lattimer

Government health advisers effectively made a U-turn in their advice on contraceptive pills, which had sparked a major health scare four years ago. Thousands of women immediately stopped taking certain types of the pill in October 1995 after the Government warned that a range of the latest 'third generation' contraceptives carried twice the risk of blood clots forming in the legs than other products. Doctors were told by the Government's Committee on Safety of Medicines (CSM) that they should switch women from the low dose third generation contraceptives to higher dose second generation pills. Medics and manufacturers criticised the way the advice was given to the media before they were told and was based on yet-to-be-published research. The makes of third generation pill affected by the health scare were Mercilon and Marvelon (manufactured by Organon), Semodene and Triadene (manufactured by Schering), and Minulet and Tri-Minulet (manufactured by Wyeth). The scare led to a surge in unwanted pregnancies and a 9% rise in the number of abortions.

At a press conference held at the Department of Health Dr Jeremy Metters, the Deputy Chief Medical Officer, issued new advice effectively advising doctors that they could prescribe third generation pills as a 'first line' contraceptive. Doctors had previously been told only to prescribe third generation pills if women were intolerant to other contraceptives and were told of the extra risk. From June this year, information leaflets contained in all packets of third generation pills will inform women of the slightly increased risk of deep vein thrombosis compared to older forms of the contraceptive. The Government still did not admit their mistake that led to the 1995 pill panic. Dr Metters said 'The Committee on Safety of Medicines gave the advice that it thought was right at the time, based on the data that was available. Since then a lot of work has been done and the data has been extensively worked over. The advice of the CSM in 1995 was that the increased risk was sufficient that women should be switched from third generation contraceptives to second generation contraceptives. The advice from the Medicines Commission now is that if women are fully informed that there is a greater risk with third generation pills and they have discussed that with their doctor, then third generation contraception should be provided.'

Dr Metters said that the scientific findings had not changed since 1995 and there was still a slightly increased risk of deep vein thrombosis from third generation pills. The risk of thrombosis for women not taking any oral contraceptive is around five cases per 100,000 women per year. The incidence in users of second generation pills is about 15 per 100,000 women per year of use, compared to around 25 in users of third generation pills. Dr Metters said 'We are still talking about tiny risks. Women should not think that this is any great risk, but they have a right to be aware of the data.' When asked if the advice given to doctors and women in 1995 was wrong, he said 'We would have been criticised if we had sat on the data. Contraception is a very personal thing and women have a right to all the information that is available.' When asked if he regretted that the scare led to a surge in the abortion rate, Dr Metters said 'Of course I regret unnecessary abortions. Any abortion and any unwanted pregnancy is a matter of regret.'

A spokeswoman for the British Medical Association said 'GPs were critical in 1995 of the way this whole issue was handled and it was a nightmare, with increased abortions and unwanted pregnancies. We now seem to be getting back to a situation where doctors can prescribe the contraception that they feel is best for their patients on the basis of their medical history and discussing it with women. This is a liberalisation of the issue and we welcome it. The new advice is being sent out to doctors today and the extra information showing the comparable risks will appear in packets of third generation contraceptives from June.'

The fact that safe, low dose third generation pills can now be returned to first line use to be welcomed, but frankly this is four years too late. The advice given by the CSM in 1995 that these pills should not be prescribed was unnecessary and alarmist. The pill scare that followed was a disaster that should never have happened. It caused a massive increase in the rates of unintended pregnancies and undermined general confidence in the safety of the pill. It reversed a downward trend in the number and rate of abortion. Abortions to women resident in Britain rose by 9 per cent in 1996 and has remained at an increased level. Where I work at the British Pregnancy Advisory Service we are still seeing women requesting abortions who wrongly believe the pill is dangerous and so miss out on a very safe and extremely effective method of contraception.
 
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