Pill scare based on wrong data EU claims

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The Independent Online
British government advice that women on seven brands of the Pill should swap to other brands because of blood-clot fears has been rejected by the European drug-safety watchdog. The decision has renewed criticism that the warnings, in October 1995, were unnecessary and premature and based on incomplete data.

Scores of unplanned pregnancies and extra abortions have been linked with the Pill scare in October 1995, which affected 1.5 million women - half of all Pill-users - taking some of the most popular brands, known as "third- generation" contraceptives.

The Committee on Safety of Medicines (CSM) based its advice on three independent studies, unpublished at that point, which suggested that these Pills, containing the synthetic hormones gestodene and desogestrel, were twice as likely to cause blood clots as other brands. The risk, however, was still half that of a woman developing a clot in pregnancy.

Family-planning experts condemned the decision, saying women should be told of the findings but not advised to swap brands unless they fell into a high-risk group for blood clots. Walter Spitzer, a principal investigator of one of the three studies, was so outraged he flew to London from Canada for just three hours to hold a press conference. He accused the CSM of breaking scientific rules by issuing a warning on the basis of unpublished and unreviewed data.

Now a six-month review of all available data by the Committee for Proprietary Medicinal Products (CPMP), a European drug-safety watchdog, has failed to establish any scientific reason to change advice to women taking these Pills in the EU, or recommend a change in the drug-licensing requirements.

This was despite heavy lobbying by British representatives and the German delegation. German scientists were the first to warn about blood-clot problems associated with some of the newer Pills and last year issued advice similar to the British. The CPMP's advice is not binding on the 15 national drug-regulatory authorities but is certainly influential and embarrassing to the British.

After a three-day meeting in London, the CPMP yesterday acknowledged the data indicates that the blood-clot risk of desogestrel or gestodene- containing Pills is higher than other brands but said the impact of "biases and confounders [in the studies] on the differences could not be fully evaluated".

The clinical relevance of differences in blood-clotting effects of the different Pills was "unknown", the CPMP said, and claims of a protective role against heart attack for the third-generation Pills was as yet "inconclusive". The committee has requested more analysis of the studies.

Rolf Bass, head of the Human Medicines Evaluation Unit at the European Agency for the Evaluation of Medicinal Products, confirmed that "for the time being there is no need for further action on these Pills".

Simon Hughes, the Liberal Democrat spokesman on health, who has tabled 150 questions on the Pill scare, yesterday said the CPMP announcement was "the best evidence yet ... that there was no medical need to warn women last autumn to stop taking third-generation oral contraceptives".

A spokesman for Organon, maker of Marvelon and Mercilon, two of the brands, said: "We are pleased with the CPMP's decision that no action is necessary which it reached after six months of careful consideration. The CSM made its decision after six days."

Conspiracy theories have been advanced to explain the Government's decision, including one that it was a plot to remove the most expensive brands of the Pill from NHS prescription. Other sources said it was to distract attention from the fight in the Commons by Michael Howard, the Home Secretary, for his political life, on the day of the Pill announcement. The Health Department has denied them all.