Swissmedic responds to criticism by health insurance provider CSS
01.09.2015
According to an analysis presented by the Lucerne-based CSS Institute for Empirical Health Economics at the beginning of September 2015, the medicinal product information for the hormonal contraceptive Yasmin is “incomplete, misleading and incorrect in parts”, and the information provided by Swissmedic to patients concerning the risks and side effects of medicinal products is wholly inadequate. Swissmedic refutes these serious allegations on the grounds that the arguments presented are based on an erroneous interpretation of figures and fail to take account of the development of data over time.
The analysis, entitled „Naive Haftpflichtklage oder tragischer Regulierungsfehler im Fall Céline contra Yasmin?“ (Naive liability action or tragic regulatory error in the case of Céline versus Yasmin?), was presented at a CSS media briefing on 31 August 2015. It deals with the consequences of a serious adverse effect of the hormonal contraceptive Yasmin. Céline, who was 16 at the time, experienced serious pulmonary embolism after she started taking the contraceptive, and, as a result, is severely handicapped and reliant on carers. Swissmedic deeply regrets the tragedy that has befallen the young woman.
In his report, the author, Prof. Konstantin Beck, levels serious allegations at Swissmedic as the agency responsible for monitoring medicinal products. He asserts that the Patient information and Information for healthcare professionals for Yasmin are incomplete, misleading and incorrect in parts, most notably as regards the information on the risk of thromboembolisms.
Swissmedic regards Professor Beck's allegations as unfounded and therefore also views the need for action he derives from them as irrelevant. In Swissmedic's view, Professor Beck's statements are based on fundamentally erroneous assumptions and incorrect figures.
In particular
- Our current level of knowledge is confused with that of March 2008, when Céline had her pulmonary embolism. The article is based on the erroneous assumption that in March 2008, Yasmin was already known to increase the risk of thromboembolisms more significantly than older, second-generation preparations.
- The assertion that the body of information available (Patient information and Information for healthcare professionals) is incomplete, misleading and contradictory is based largely on the incorrect reproduction of the figures provided in the Patient information and Information for healthcare professionals as well as the studies available at the time.
- The extrapolations of relative and absolute risk that are derived from these figures are correspondingly questionable.
In fact the Federal Supreme Court stated in its verdict on Céline's family's claim for damages against Bayer, the manufacturer of Yasmin, that the medicinal product information (i.e. the Patient information and Information for healthcare professionals) contains all relevant details. It also said that in the case of prescription-only medicinal products, it was necessary to obtain the specialist knowledge of the doctor since patients are unable to assess the risks unaided.
Background information
It is one of Swissmedic's core tasks to ensure that information on medicinal products is fully up to date. In performing this task, Swissmedic records and assesses reports of adverse effects from Switzerland, observes international developments and works with partner authorities.
As regards hormonal contraceptives, of which Yasmin is one, Swissmedic has repeatedly provided information on new findings and updated the medicinal product information (the Patient information and Information for healthcare professionals) accordingly. In some cases it has been the first agency to do so. All medical information have been published on the Internet. In doing so, Swissmedic has worked closely with the Swiss Society of Gynaecology and Obstetrics (SGGG).
While new adverse effects change a medicinal product's risk profile, not every new adverse effect results in that product being withdrawn from the market. This does not occur until the overall risk-benefit assessment produces a negative result.
