British action 'based on sketchy evidence'

IMRE KARACS

Bonn

The German pharmaceutical company Schering, which markets Femodene, reacted with anger yesterday to the British blacklist of its top-selling drug. "This is a very, very isolated action by the British authorities," stressed Ralf Harenberg, Schering's spokesman at its Berlin headquarters.

But the British committee's "surprising and unreasonable action", as Schering put it, is not without precedent in the drug's country of origin. Following a report by Professor Peter Schonhofer in 1989, which first identified Femodene's side- effects, the German press kept scare stories running for more than a year. In the ensuing panic, Schering's market share in Germany collapsed.

The government drugs licensing agency, however, has never taken action as drastic as that by the British authorities. Germany's official position is that the evidence against the "third-generation oral contraceptives" singled out in London is still sketchy.

At the peak of the Femodene scare in 1989, the German health authorities instructed doctors to report the drug's side-effects. Professor Schonhofer's findings were later refuted by other scientists.

But the uproar in Britain may yet change the German authorities' relaxed position. Yesterday, the government was engaged in feverish talks with the pharmaceutical companies concerned, and an announcement was due after the weekend.

Meanwhile, the pill remains by far the most popular form of contraception. Oral contraceptives are available on demand from the local GP and, while some apply an age limit, in practice anyone who wants to go on the pill can do so without parental consent. Unlike in Britain, the charities have little role to play in this form of family planning.

If there is a debate in Germany about contraception, it is more of an ideological kind. After reunification in 1990, the East inherited an abortion- on-demand policy from communist days which the West, particularly the Catholic regions, found hard to stomach. The East has finally been brought in line and women there have taken with gusto to the pill denied by the inefficient health system of old.

This situation will not change even if the German authorities were to follow the British line. After the debacle of 1989-90, German women switched from "third-generation" brands, and the drug companies merely reshuffled their product range. Schering claims it can now do the same in Britain, where its top drug Femodene earned DM35m (pounds 15.76m) last year.