A year ago tomorrow 1.5 million women - half of all those using oral contraception - were advised to change their brand of Pill after unpublished data suggested third-generation Pills were twice as likely to cause clots as older, cheaper brands.
In the ensuing panic thousands of women stopped taking their Pills, resulting in claims of unplanned pregnancies, terminations and, more recently, overbooking in maternity wards. Family doctor services suffered because of up to 2 million extra consultations from anxious women.
Many doctors, scientists and family planning experts criticised the decision by the Committee on Safety of Medicines to issue its warning on seven of the most popular Pill brands, before publication and analysis of the studies. Those involved in the research were outraged.
Yesterday Stephen Killick, professor of reproductive medicine at Hull University, said that the studies' conclusions were "interesting but really rather unremarkable and of so little risk to be of almost no concern to the individual woman".
Speaking at a symposium in central London organised by the Contraceptive Alliance (an umbrella group for family planning doctors, nurses, charities, patients' groups and manufacturers) Professor Killick said that apart from Germany, every other European drug regulatory authority had waited for publication of the data before making a decision. None subsequently issued a Pill alert, nor had prescribing practice changed. In the UK the market share of the third-generation contraceptives fell from around 40 per cent to about 10 per cent.
An expert group from the European drug safety agency which advises members of the European Union, also refused to bow to pressure from the British and German governments. In the US action was taken for legal reasons but there was little media coverage and certainly no Pill scare.
The risk of blood clots (venous thrombosis) for women not on the Pill is about five per 100,000; for women taking second-generation Pills it rises to 15/100,000; for women on third-generation Pills (those containing the synthetic hormones gestodene and desogestrel) it is 30/100,000; and for a pregnant woman the risk is 60/100,000.
Professor Killick said women should be told of the increased risk of the third-generation Pills, but this had to be put into perspective, and the protective effect of the Pill against ovarian cancer and heart disease far outweighed the blood clot concerns.
The Pill has been at the centre of "scare" stories - most notably about breast cancer - since it first became available in the 1960s. However, the 1995 debacle has raised many questions about the Government's handling of the information, and conspiracy theories as to the reasons for it.
Health ministers had mooted the idea of taking some brands of the Pill off NHS prescription since the early 1990s. The third-generation Pills were the most expensive and possible savings of up to pounds 25m could be achieved if their availability was restricted. Other theories suggest that health ministers at the Department of Health was keen to pre-empt a decision by other European countries, and had fully expected them to follow the UK's lead. Certainly some members of the Committee on Safety of Medicines felt they were rushed into the decision.
Yet another explanation is that the Pill scare was "got up" to distract the media from the troubles of the Home Secretary, Michael Howard, over prisons which had prompted calls for his resignation. What is indisputable is that Tom Sackville, the junior health minister involved in the Pill decision, was quietly moved to the Home Office six weeks after the scare. "It was a monumental cock-up at every level, and acknowledged as such," a source close to the CSM said yesterday.Reuse content