No evidence Pill posed higher risk

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The Independent Online
The "third-generation" contraceptive Pills at the centre of a major scare last year, pose no higher risk to public health than other brands of oral contraceptives, according to the European Commission.

The statement by Martin Bangemann, the European Commissioner with responsibility for licensing medicines, raises new questions about the controversial Government advice to 1.5 million British women in October 1995 to change from these Pills to older, cheaper, brands.

The ensuing panic led to thousands of unplanned pregnancies, and has been blamed for almost 3,000 extra abortions in England and Wales in the first quarter of 1996, a rise of 6.7 per cent on 1995. This is the highest figure since 1991, according to the Office of National Statistics which released the figures yesterday.

Chris Smith, Labour's spokesman on health, yesterday accused the Government of "bungling" the Pill safety issue. In addition, maternity units around the country have reported higher than expected birth rates of up to 25 per cent.

The Government acted after the Committee on Safety of Medicines had assessed the findings of three unpublished studies which linked third-generation Pills, containing the synthetic hormones desogestrel and gestodene, with an increased risk of blood clots.

Analysis of the same data by the European drug safety advisory committee subsequently concluded that no action was necessary other than informing women of the possible increased risk. Only Germany and Norway followed the UK lead in advising women against the Pills.

Further analysis and submissions by the Pill manufacturers to the Committee for Proprietary Medicinal Products, which advises EU members, found no reason to issue new advice or change the product licence for the drugs.

In a written reply to a question by Graham Watson, a Liberal Democrat MEP, Mr Bangemann said: "Following that consideration it was concluded that from a public health point of view, there was no evidence that the major benefits of risks are different for desogestrel or gestodene-containing oral contraceptives..."

The Department of Health has consistently refused to admit that it mishandled the Pill alert, although Sir Kenneth Calman, the Chief Medical Officer, conceded in his annual report for 1995 that "the absolute risk [of a blood clot] is very small in all types of oral contraceptives, and much smaller than the risk of pregnancy ... The message to continue to take the oral contraceptive Pill, seemed to be ignored in the pressure for action."

Health ministers are still pursuing a change to the licence for third- generation Pills, to position them as "second-line" contraceptives. The manufacturers are fighting this and their appeal will be heard by the CSM on 28 November.

Market share for the seven brands affected has fallen from 40 to 10 per cent.

Dr Andrew Watt, a drug safety expert and former Department of Health employee, yesterday said that "it remains my view that one-and-a-half million British women were caused unnecessary anxiety by substandard and sloppy consideration of incomplete data".

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