MCA under fire as Schering withdraws pill ad
Thursday , December 12, 2002
The Medicines Control Agency has come under criticism following the withdrawal of Schering Health Care's UK adverts for its contraceptive pill Yasmin. The MCA initially approved the ads in June, but after reviewing the evidence decided that some of the company's claims were misleading could not be substantiated and has ordered the ads to be withdrawn. Schering launched Yasmin in the UK the April amid claims that it would not lead to weight gain, a common issue for women taking other oral contraceptives. The company also claimed the pill, which is more expensive than rival products, had a positive effect on pre-menstrual symptoms and skin and hair condition. These claims had previously been challenged by Prof Joe Collier, Editor of the Drug and Therapeutics Bulletin (DTB) and Professor of Medicines Policy and Honorary Consultant at St George's Hospital Medical School, who has now called the MCA behaviour "unacceptable". "There should be a full inquiry into how the MCA, which is partly funded by the pharmaceutical industry, allowed this advert to go through", he told The Observer. "This level of incompetence, which would appear to favour the industry rather than the public, is totally unacceptable". Schering threaten to take legal action against the DTB, part of the Consumers' Association, although this has now been dropped. An investigation by the ABPI Prescriptions Medicines Code of Practice Authority ruled that Schering was in breach of advertising guidelines on 10 counts. "The panel considers that the claims that Yasmin had been shown repeatedly to have no associated weight gain was a strong, absolute claim which did not reflect all of the evidence and was misleading in that regard, and could not be substantiated", said the PMCPA. It also said claims that the pill was "truly different" and had a positive effect on skin condition were also unsubstantiated. Schering said it would appeal against the decision but told Reuters it believed the claims accurately reflect data published in peer-reviewed journals. The company estimated peak annual sales of the contraceptive could exceed E400 million (£256 million). Meanwhile, Schering AG is to collaborate with fertility rivals Organon in the development of a male contraceptive pill. A phase II multicentre trial has already been designed with the companies estimating a product could be available within five to seven years. "The collaboration between Organon and Schering offers a firm basis for the challenges still to be undertaken in the development of an effective and safe male contraceptive", said Dr Driek Vergouwen, Executive VP, Research and Development at Organon International.
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